Substance,CAS,key_information,Extraction_Timestamp,dossierType,page,linkPage,Toxicity Type,Route,Dose descriptor,Effect level,Endpoint conclusion,Species 2-methoxyethanol,109-86-4," ORAL ROUTE RAT (reliable studies only reported.  Gavage unless stated otherwise) - NOAEL<70mg/kg (90 day drinking water) (testes, thymus) - BMDL10=15.4mg/kg (10 day) (creatine:creatinine ratio) - NOAEL<50mg/kg (10 day) (thymus) - NOAEL<50mg/kg (5 day) (testes, sperm) - NOAEL<161mg/kg (21 day-drinking water) (thymus, immune system) - NOAEL=50mg/kg (11 day) (sperm) - NOAEL<100mg/kg (4 day) (testes, white blood cells) ORAL ROUTE MOUSE - NOAEL=295mg/kg (90 day - drinking water) (testes, spleen) - NOAEL=125mg/kg (5 week) (testes, sperm) DERMAL ROUTE (rat, all available studies reported) - NOAEL (4 week) <100mg/kg (occluded); 100mg/kg (non-occluded.)  (Body weight gain) - NOAEL (13 week) <1000mg/kg - NOAEL (1 week) <625mg/kg (occluded); =1250mg/kg (non-occluded) (sperm count, testes-epididymides weight) INHALATION (rat unless specified, reliability 1 or 2 studies only included.) - NOAEC (90 day): female: 30ppm (body wt, clin chem.); male 100ppm (body wt, liver-testes wt, haematology) - NOAEC (90 day, rabbit): female 30ppm (thymus wt, haematology); male: <30ppm (testes) - NOAEC (2 wk): <100ppm (male and female) (WBC) - NOAEC (2 wk, mouse): female 100ppm (thymus); male 300ppm (thymus-liver-testes wt) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/901f6295-c572-4b7e-a62e-9f14e481aaa7/documents/IUC5-eae2ba76-c92d-4d6e-8b85-d76cf86373f9_93644b5c-354b-4f24-820a-ac821cde84fc.html,,,,,, 2-methoxyethanol,109-86-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/901f6295-c572-4b7e-a62e-9f14e481aaa7/documents/IUC5-eae2ba76-c92d-4d6e-8b85-d76cf86373f9_93644b5c-354b-4f24-820a-ac821cde84fc.html,Short-term repeated dose toxicity – systemic effects,oral,BMDL10,15.6 mg/kg bw/day,, 2-methoxyethanol,109-86-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/901f6295-c572-4b7e-a62e-9f14e481aaa7/documents/IUC5-eae2ba76-c92d-4d6e-8b85-d76cf86373f9_93644b5c-354b-4f24-820a-ac821cde84fc.html,Short-term repeated dose toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,, 2-methoxyethanol,109-86-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/901f6295-c572-4b7e-a62e-9f14e481aaa7/documents/IUC5-eae2ba76-c92d-4d6e-8b85-d76cf86373f9_93644b5c-354b-4f24-820a-ac821cde84fc.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,95 mg/m3,, 2-methoxyethanol,109-86-4," ORAL LD50 values: Rat, male: 2460mg/kg Rat, male: 2257mg/kg (fasted), 3930mg/kg (non-fasted) Rat, male: 3250mg/kg Rat, female: 3400mg/kg Guinea pig, male/female; 950mg/kg INHALATION LC50 values (all rat): >20mg/l (male and female) >16mg/l.  NOEC=0.95mg/l (male) ~16mg/l (male) DERMAL LD50 (all male rabbit) 3930mg/kg 1340ml/kg ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/901f6295-c572-4b7e-a62e-9f14e481aaa7/documents/IUC5-ad9d1ff2-557a-4004-98fc-4be9b0e0c6d1_93644b5c-354b-4f24-820a-ac821cde84fc.html,,,,,, 2-methoxyethanol,109-86-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/901f6295-c572-4b7e-a62e-9f14e481aaa7/documents/IUC5-ad9d1ff2-557a-4004-98fc-4be9b0e0c6d1_93644b5c-354b-4f24-820a-ac821cde84fc.html,,oral,LD50,950 mg/kg bw,adverse effect observed, 2-methoxyethanol,109-86-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/901f6295-c572-4b7e-a62e-9f14e481aaa7/documents/IUC5-ad9d1ff2-557a-4004-98fc-4be9b0e0c6d1_93644b5c-354b-4f24-820a-ac821cde84fc.html,,dermal,LD50,"1,340 mg/kg bw",adverse effect observed, 2-methoxyethanol,109-86-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/901f6295-c572-4b7e-a62e-9f14e481aaa7/documents/IUC5-ad9d1ff2-557a-4004-98fc-4be9b0e0c6d1_93644b5c-354b-4f24-820a-ac821cde84fc.html,,inhalation,LC50,16 mg/m3,adverse effect observed, "Decane-1,10-diol",112-47-0," A 4-week toxicity study is available on 1,6-hexanediol, an analogue substance of 1,10 -decanediol. The oral administration (by gavage) of 1,6-hexanediol in dose levels of 100, 400 and 1000 mg/kg bw/d to Wistar rats caused no substance-related effects. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1aa39015-d882-4c51-9a01-6c65c2fb8826/documents/59649c76-614c-4f15-9664-7cd759ffe604_7551dcde-5cf1-4b7a-b3d3-69489331aace.html,,,,,, "Decane-1,10-diol",112-47-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1aa39015-d882-4c51-9a01-6c65c2fb8826/documents/59649c76-614c-4f15-9664-7cd759ffe604_7551dcde-5cf1-4b7a-b3d3-69489331aace.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Decane-1,10-diol",112-47-0," The acute toxicity of 1,10 -decanediol was evaluated by oral and dermal route. The oral and dermal LD50 of 1,10 -decanediol are higher than 10 000 and 2000 mg/kg bw respectively. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aa39015-d882-4c51-9a01-6c65c2fb8826/documents/4e0735ff-c5fe-4921-b55a-fa4c6619c048_7551dcde-5cf1-4b7a-b3d3-69489331aace.html,,,,,, "Decane-1,10-diol",112-47-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aa39015-d882-4c51-9a01-6c65c2fb8826/documents/4e0735ff-c5fe-4921-b55a-fa4c6619c048_7551dcde-5cf1-4b7a-b3d3-69489331aace.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Decane-1,10-diol",112-47-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aa39015-d882-4c51-9a01-6c65c2fb8826/documents/4e0735ff-c5fe-4921-b55a-fa4c6619c048_7551dcde-5cf1-4b7a-b3d3-69489331aace.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,2,3,4,4a,5,6,7-octahydro-2,5,5-trimethyl-2-naphthol",41199-19-3,For Ambrinol 95 the LD50 is >2000 mg/kg bw which based on read-across from a multi-constituent containing 56% Ambrinol and a similar analogue tested in an OECD TG 401. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc65444d-68e3-476e-ad3f-381c9c8516fe/documents/8e195fe1-b3c0-4023-b838-2755714b7607_2e32070a-8b92-48de-a3ae-0bfa7a4a069c.html,,,,,, "1,2,3,4,4a,5,6,7-octahydro-2,5,5-trimethyl-2-naphthol",41199-19-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc65444d-68e3-476e-ad3f-381c9c8516fe/documents/8e195fe1-b3c0-4023-b838-2755714b7607_2e32070a-8b92-48de-a3ae-0bfa7a4a069c.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1,2,3,4,4a,7,8,8a-octahydro-2,4a,5,8a-tetramethyl-1-naphthyl formate",65405-72-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/984ece17-9d23-429f-882d-79347038fee8/documents/IUC5-e20ff8ba-63ec-43f8-9d70-c0136e3afa66_01474e9a-c26b-4bab-8dbe-47169d7ddaea.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "DL-hexane-1,2-diol",6920-22-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Fifteen animals/sex/dose group received a daily dermal dose of test article at dose levels of 0, 350, 700, or 1000 mg/kg ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f68268b3-04e7-4815-9f2d-9a16cc1cc022/documents/IUC5-541d265f-4fcf-46dd-a586-a7d34994484a_c5f93af0-ea0f-43c7-9b16-fa661da56711.html,,,,,, "DL-hexane-1,2-diol",6920-22-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f68268b3-04e7-4815-9f2d-9a16cc1cc022/documents/IUC5-541d265f-4fcf-46dd-a586-a7d34994484a_c5f93af0-ea0f-43c7-9b16-fa661da56711.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,700 mg/kg bw/day,,rat "DL-hexane-1,2-diol",6920-22-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Although the study dates pre-OECD protocols draft protocols were already available at that time and used as basis for study design. Even though the study has slight reporting deficiencies the number of animals was high (in total 63 animals used) and dose/response relationship was satisfactory, even at such high doses used in this study (up to 10 ml/kg i.e. 9500 mg/kg bw). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f68268b3-04e7-4815-9f2d-9a16cc1cc022/documents/IUC5-60e77b87-a54f-401b-ac22-a496ae7fea71_c5f93af0-ea0f-43c7-9b16-fa661da56711.html,,,,,, "DL-hexane-1,2-diol",6920-22-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f68268b3-04e7-4815-9f2d-9a16cc1cc022/documents/IUC5-60e77b87-a54f-401b-ac22-a496ae7fea71_c5f93af0-ea0f-43c7-9b16-fa661da56711.html,,oral,LD50,"6,166 mg/kg bw",no adverse effect observed, "1,3-bis(isocyanatomethyl)cyclohexane",38661-72-2," Based on the results of a dose range finding study with analogue 1,4 -H6XDI it was concluded that a repeated dose study with the undiluted substance is not possible. Taking into account that it was impossible to develop an analytical method it was concluded that it is technically not feasible to dose animals to a stable form of the test item and to conduct a repeated dose study. The considerations are also included in the read across document, attached in Section 13. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a3f06ea-bb27-457c-baed-447e1dbb5d0f/documents/285e0afb-e402-4034-8be3-c14d2004b20f_f9d541c6-5c8c-4106-b7d4-5aeb79fee224.html,,,,,, "1,3-bis(isocyanatomethyl)cyclohexane",38661-72-2," In an acute oral toxicity test, the oral LD50 of 1,4-H6XDI was found to be > 300 mg/kg bw and < 2000 mg/kg bw. This result is read across to 1,3-H6XDI. In an acute oral toxicity study with mice the LD50 was found to be between 520.8 and 625 mg/kg body weight. In an oral acute toxicity study, the LD50 of 1,3-H6XDI was found to be > 1600 mg/kg bw and < 2500 mg/ kg bw in  male and female rats. In an acute inhalation toxicity, conducted equivalent to OECD 403, the LC50 of 1,3-H6XDI was found to be > 0.147 mg/L and < 0.239 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a3f06ea-bb27-457c-baed-447e1dbb5d0f/documents/5c5b1fca-f3c8-4ec0-b860-8a1cf1f6f7d7_f9d541c6-5c8c-4106-b7d4-5aeb79fee224.html,,,,,, "1,3-bis(isocyanatomethyl)cyclohexane",38661-72-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a3f06ea-bb27-457c-baed-447e1dbb5d0f/documents/5c5b1fca-f3c8-4ec0-b860-8a1cf1f6f7d7_f9d541c6-5c8c-4106-b7d4-5aeb79fee224.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "1,3-bis(isocyanatomethyl)cyclohexane",38661-72-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a3f06ea-bb27-457c-baed-447e1dbb5d0f/documents/5c5b1fca-f3c8-4ec0-b860-8a1cf1f6f7d7_f9d541c6-5c8c-4106-b7d4-5aeb79fee224.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "1,3-bis(isocyanatomethyl)cyclohexane",38661-72-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a3f06ea-bb27-457c-baed-447e1dbb5d0f/documents/5c5b1fca-f3c8-4ec0-b860-8a1cf1f6f7d7_f9d541c6-5c8c-4106-b7d4-5aeb79fee224.html,,inhalation,LC50,147.1 mg/m3,adverse effect observed, "1,3-dimethyl-3-phenylbutyl acetate",68083-58-9," Based on an OECD Guideline 407 and GLP, a NOEL (No Observed Effect Level) for the read-across substance, 4-methyl-4-phenylpentan-2-ol, of 100 mg/kg bw/day was identified. The findings at 400mg/kg/day, including short term transient neurological effects in a few animals immediately post dosing, could not be seen in a longer duration study at the same dose, and increases in relative kidney weights were not accompanied by evidence of kidney damage (biochemcial or histopathogical). That´s why these findings were considered to be incidental and a NOAEL (No Observed Adverse Effect Level) for the read-across substance, 4-methyl-4-phenylpentan-2-ol, of 400mg/kg bw/day can be identified. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d7a83bf-62cb-426d-81eb-8b138956cc28/documents/52a05964-9371-4f0d-8094-78210f8d0224_8c66ad8d-424b-4413-bd59-7962a0671f1e.html,,,,,, "1,3-dimethyl-3-phenylbutyl acetate",68083-58-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d7a83bf-62cb-426d-81eb-8b138956cc28/documents/52a05964-9371-4f0d-8094-78210f8d0224_8c66ad8d-424b-4413-bd59-7962a0671f1e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,494.32 mg/kg bw/day,,rat "1,3-dimethyl-3-phenylbutyl acetate",68083-58-9," No mortality was observed in 6 female Sprague-Dawley rats in an acute oral toxicity study with the test substance, conducted in accordance with OECD TG 423 at a limit dose of 2000 mg/kg. The LD50 was therefore identified as >2000 mg/kg p.o. and the median lethal dose derived was LD50 cut off ≥ 5,000 mg/kg b.w. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d7a83bf-62cb-426d-81eb-8b138956cc28/documents/9d5c4b91-b52f-4376-802c-91a1d696bca7_8c66ad8d-424b-4413-bd59-7962a0671f1e.html,,,,,, "1,3-dimethyl-3-phenylbutyl acetate",68083-58-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d7a83bf-62cb-426d-81eb-8b138956cc28/documents/9d5c4b91-b52f-4376-802c-91a1d696bca7_8c66ad8d-424b-4413-bd59-7962a0671f1e.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "Butane-1,4-diol",110-63-4,"Oral, rat: NOAEL: 225 mg/kg bw/day (subchronic, read-across) (NTP, 1992) Oral, mouse: NOAEL: 525 mg/kg bw/day (subchronic, read-across) (NTP, 1992) Oral, rat: NOAEL:200 mg/kg bw/day (subacute) (MHW, 1999) Oral, rat: NOAEL: 500 mg/kg bw/day (subacute) (Jedrychowski, 1992) Inhalation, rat: NOAEC 1 mg/L (subacute) (DuPont, 1984) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): NOAEC is based on data from two similar reports on a 14-d repeated exposure study with aerosols. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Several subacute and subchronic studies on rats and mice were conducted in line with OECD guidelines or at an equivalent level. They are considered reliable for assessment of repeated dose toxicity of the test substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63769c0b-c24b-4be0-b2d5-03b356bc89fe/documents/IUC5-dac02682-0a8c-47f1-90d3-41987bcf492a_29e6cb8a-034c-4cdd-b265-07ecc6b07b77.html,,,,,, "Butane-1,4-diol",110-63-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63769c0b-c24b-4be0-b2d5-03b356bc89fe/documents/IUC5-dac02682-0a8c-47f1-90d3-41987bcf492a_29e6cb8a-034c-4cdd-b265-07ecc6b07b77.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,100 mg/m3",,rat "Butane-1,4-diol",110-63-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63769c0b-c24b-4be0-b2d5-03b356bc89fe/documents/IUC5-dac02682-0a8c-47f1-90d3-41987bcf492a_29e6cb8a-034c-4cdd-b265-07ecc6b07b77.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,225 mg/kg bw/day,,rat "Butane-1,4-diol",110-63-4," LD50, oral rat: 1500 mg/kg bw LC50, inhal rat: >5.1 mg/L and >15 mg/L LD50, dermal rat: >2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63769c0b-c24b-4be0-b2d5-03b356bc89fe/documents/IUC5-41c68db7-dadd-4b1f-8417-9ad7474ca883_29e6cb8a-034c-4cdd-b265-07ecc6b07b77.html,,,,,, "Butane-1,4-diol",110-63-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63769c0b-c24b-4be0-b2d5-03b356bc89fe/documents/IUC5-41c68db7-dadd-4b1f-8417-9ad7474ca883_29e6cb8a-034c-4cdd-b265-07ecc6b07b77.html,,oral,LD50,"1,500 mg/kg bw",adverse effect observed, "Butane-1,4-diol",110-63-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63769c0b-c24b-4be0-b2d5-03b356bc89fe/documents/IUC5-41c68db7-dadd-4b1f-8417-9ad7474ca883_29e6cb8a-034c-4cdd-b265-07ecc6b07b77.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Butane-1,4-diol",110-63-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63769c0b-c24b-4be0-b2d5-03b356bc89fe/documents/IUC5-41c68db7-dadd-4b1f-8417-9ad7474ca883_29e6cb8a-034c-4cdd-b265-07ecc6b07b77.html,,inhalation,discriminating conc.,"9,400 mg/m3",no adverse effect observed, Tetramethylene dimethacrylate,2082-81-7,"Subacute oral toxicity was tested in an OECD 422 using 1,4 butanediol dimethacrylate. The NOAEL is 300 mg/kg/d due to histopathological findings in the forestomach (males and females) (focal hyperplasia of the squamous epthelium of the forestomach associated with hyperkeratosis) and a reduced body weight and food consumption at 1000 mg/kg bw/d (see expert statement, Chapter 13.2). Further effects (e.g. reduced thymus weight, changes in clinical biochemistry) are considered to be stress-related due to the emerging Methacrylic acid leading to a reduced food consumption and consequently a reduced body weight. The increased kidney weight is considered as not adverse since there were microscopic changes or functional restrictions observed. The minimal degree of multifocal perilobular hepatocytic vacuolation observed in the liver of 3/10 high dose females is considered as normal background observation in animal studies and therefore not adverse.  No effects on the nervous system were observed.    Subchronic oral toxicity was tested in an OECD 408 using 1,4-BDDMA. The NOAEL is 500 mg/kg bw/d based on weigth loss in male rats associated with metabolic stress and the high level of ALT.    ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f9e58d3-0dfc-486f-9eab-569c95784727/documents/IUC5-968b8b1b-6788-44ae-9f87-34b195be9ef0_1e1a6ea8-d212-4930-8049-182e29db7e50.html,,,,,, Tetramethylene dimethacrylate,2082-81-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f9e58d3-0dfc-486f-9eab-569c95784727/documents/IUC5-968b8b1b-6788-44ae-9f87-34b195be9ef0_1e1a6ea8-d212-4930-8049-182e29db7e50.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Tetramethylene dimethacrylate,2082-81-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f9e58d3-0dfc-486f-9eab-569c95784727/documents/IUC5-968b8b1b-6788-44ae-9f87-34b195be9ef0_1e1a6ea8-d212-4930-8049-182e29db7e50.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,ca.500 mg/kg bw/day,,rat Tetramethylene dimethacrylate,2082-81-7,"Acute oral toxicity: LD50 (rat, combined) = 10066 mg/kg bw; OECD Guideline 401; pre-GLP studyAcute inhalation toxicity: no relevant route of exposure due to the low vapour pressure (see IUCLID section 7.1)Acute dermal toxicity: LD 50 (rat) > 2000 mg/kg bw; OECD 402; GLP-Guideline study Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): One relevant, reliable (Klimisch score = 2) and adequate study is available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f9e58d3-0dfc-486f-9eab-569c95784727/documents/IUC5-08c16091-4776-4516-9ca9-1c98ce1a8518_1e1a6ea8-d212-4930-8049-182e29db7e50.html,,,,,, Tetramethylene dimethacrylate,2082-81-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f9e58d3-0dfc-486f-9eab-569c95784727/documents/IUC5-08c16091-4776-4516-9ca9-1c98ce1a8518_1e1a6ea8-d212-4930-8049-182e29db7e50.html,,oral,LD50,"10,066 mg/kg bw",no adverse effect observed, Tetramethylene dimethacrylate,2082-81-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f9e58d3-0dfc-486f-9eab-569c95784727/documents/IUC5-08c16091-4776-4516-9ca9-1c98ce1a8518_1e1a6ea8-d212-4930-8049-182e29db7e50.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Naphthalene-1,5-diol",83-56-7," Based on effects on kidneys and forestomach, a No Observed Adverse Effect Level (NOAEL) for naphthalene-1,5-diol of 50 mg/kg/day was established (oral route, 90 days). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19a14b3c-afcc-4f6a-bd95-f92677aaee9e/documents/39f31397-7a4c-488c-9550-e3b01a280b4a_c59a905c-5f0f-40b5-9b8f-02f4aba64311.html,,,,,, "Naphthalene-1,5-diol",83-56-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19a14b3c-afcc-4f6a-bd95-f92677aaee9e/documents/39f31397-7a4c-488c-9550-e3b01a280b4a_c59a905c-5f0f-40b5-9b8f-02f4aba64311.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Naphthalene-1,5-diol",83-56-7," LD50 (oral, rat) > 5000 mg/kg b.w ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19a14b3c-afcc-4f6a-bd95-f92677aaee9e/documents/ee109e4f-fd57-40f4-9f9b-32462ba2de1b_c59a905c-5f0f-40b5-9b8f-02f4aba64311.html,,,,,, "Naphthalene-1,5-diol",83-56-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19a14b3c-afcc-4f6a-bd95-f92677aaee9e/documents/ee109e4f-fd57-40f4-9f9b-32462ba2de1b_c59a905c-5f0f-40b5-9b8f-02f4aba64311.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Pentane-1,5-diol",111-29-5,"Repeated dose toxicity: - oral: NOAEL = 1000 mg/kg bw/day (OECD 422; 1,5-pentanediol  CAS 111-29-5)- oral: NOAEL = 1000 mg/kg bw/day (OECD 407; analogue 1,6-hexanediol  CAS 629-11-8) - oral: NOAEL = 400 mg/kg bw/day (OECD 408; analogue 1,6-hexanediol CAS 629-11-8) - oral: NOAEL (systemic parental toxicity) = 1000 mg/kg bw/d (OECD 422; metabolite d-valerolactone CAS 542-28-9) - oral: NOAEL (local parental toxicity)=  300 mg/kg bw/d (OECD 422; metabolite d-valerolactone CAS 542-28-9)   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a2f9f1d-55e5-4cb4-99eb-f5a21519f5c5/documents/IUC5-107b6909-3f31-46a6-ab53-1e95eddf7e63_72bd0b1f-1df5-4d68-9f6d-bfb28084f4e0.html,,,,,, "Pentane-1,5-diol",111-29-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a2f9f1d-55e5-4cb4-99eb-f5a21519f5c5/documents/IUC5-107b6909-3f31-46a6-ab53-1e95eddf7e63_72bd0b1f-1df5-4d68-9f6d-bfb28084f4e0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,, "Pentane-1,5-diol",111-29-5,"1,5 pentandiol is of low acute toxicity via all routes of exposure. The following lethal doses after acute exposures have been determined in the key studies:- oral: LD50 = ca. 10000 mg/kg bw- dermal: LD50 > 19800 mg/kg bw- inhalative: no deaths within 7 h exposure to saturated vapor atmosphere(IRT) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a2f9f1d-55e5-4cb4-99eb-f5a21519f5c5/documents/IUC5-0171108c-1ea5-459f-a216-9e51eb62935c_72bd0b1f-1df5-4d68-9f6d-bfb28084f4e0.html,,,,,, "Pentane-1,5-diol",111-29-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a2f9f1d-55e5-4cb4-99eb-f5a21519f5c5/documents/IUC5-0171108c-1ea5-459f-a216-9e51eb62935c_72bd0b1f-1df5-4d68-9f6d-bfb28084f4e0.html,,oral,LD50,"10,000 mg/kg bw",, "Pentane-1,5-diol",111-29-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a2f9f1d-55e5-4cb4-99eb-f5a21519f5c5/documents/IUC5-0171108c-1ea5-459f-a216-9e51eb62935c_72bd0b1f-1df5-4d68-9f6d-bfb28084f4e0.html,,dermal,LD50,"19,800 mg/kg bw",, Hexamethylene diisocyanate,822-06-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): The study is GLP compliant and is of high quality (Klimisch score=1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The study is GLP compliant and is of high quality (Klimisch score=1) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/90ecf9af-9d81-4a61-9d85-08291a24380f/documents/6ae6a8d0-e301-42e1-a9db-f8774c2eb3e9_bbbebb23-d5e6-477e-9d73-d0654b18f8f7.html,,,,,, Hexamethylene diisocyanate,822-06-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/90ecf9af-9d81-4a61-9d85-08291a24380f/documents/6ae6a8d0-e301-42e1-a9db-f8774c2eb3e9_bbbebb23-d5e6-477e-9d73-d0654b18f8f7.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.035 mg/m3,adverse effect observed,rat Hexamethylene diisocyanate,822-06-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The studies are of sufficient quality (Klimisch score=2) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The study is GLP compliant and is of high quality (Klimisch score=1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study is of sufficient quality (Klimisch score=2) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90ecf9af-9d81-4a61-9d85-08291a24380f/documents/7401d2fc-2871-42ba-8c1f-2db819e70648_bbbebb23-d5e6-477e-9d73-d0654b18f8f7.html,,,,,, Hexamethylene diisocyanate,822-06-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90ecf9af-9d81-4a61-9d85-08291a24380f/documents/7401d2fc-2871-42ba-8c1f-2db819e70648_bbbebb23-d5e6-477e-9d73-d0654b18f8f7.html,,oral,LD50,746 mg/kg bw,adverse effect observed, Hexamethylene diisocyanate,822-06-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90ecf9af-9d81-4a61-9d85-08291a24380f/documents/7401d2fc-2871-42ba-8c1f-2db819e70648_bbbebb23-d5e6-477e-9d73-d0654b18f8f7.html,,dermal,discriminating dose,"7,000 mg/kg bw",no adverse effect observed, Hexamethylene diisocyanate,822-06-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90ecf9af-9d81-4a61-9d85-08291a24380f/documents/7401d2fc-2871-42ba-8c1f-2db819e70648_bbbebb23-d5e6-477e-9d73-d0654b18f8f7.html,,inhalation,LC50,124 mg/m3,adverse effect observed, Hexamethylenediamine,124-09-4,"The NOAEC/inhalation for rat = 10 mg/m3/day for upper respiratory tract local damage (larynx and nose), (kr: 2, OECD 413, NTP, 1993).The NOAEL/oral for rabbits = 25 mg/kg bw/day (kr:1, prenatal developmental toxicity study, OECD 414, CiToxLab, 2017 ) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6790f142-425a-46ce-a232-f0d03685c74f/documents/410e02ed-c6de-435b-ad97-ee8dc8b2f34c_16d7c6da-884e-4a4e-bd47-6b2e7cc62541.html,,,,,, Hexamethylenediamine,124-09-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6790f142-425a-46ce-a232-f0d03685c74f/documents/410e02ed-c6de-435b-ad97-ee8dc8b2f34c_16d7c6da-884e-4a4e-bd47-6b2e7cc62541.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rabbit Hexamethylenediamine,124-09-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6790f142-425a-46ce-a232-f0d03685c74f/documents/410e02ed-c6de-435b-ad97-ee8dc8b2f34c_16d7c6da-884e-4a4e-bd47-6b2e7cc62541.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,10 mg/m3,,rat Hexamethylenediamine,124-09-4,"Oral: LD50 Combined (Males and females) = 1160 mg/kg.bw in rats (kr: 2, Directive 92/69/EEC, B.1)Dermal: LD50 Combined (Males and females) = 1900 mg/kg.bw in rats (Kr: 2, Directive 92/69/EEC, B.3) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6790f142-425a-46ce-a232-f0d03685c74f/documents/d3edec2d-e9fe-487f-9e70-4f67ce7a0724_16d7c6da-884e-4a4e-bd47-6b2e7cc62541.html,,,,,, Hexamethylenediamine,124-09-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6790f142-425a-46ce-a232-f0d03685c74f/documents/d3edec2d-e9fe-487f-9e70-4f67ce7a0724_16d7c6da-884e-4a4e-bd47-6b2e7cc62541.html,,oral,LD50,"1,160 mg/kg bw",, Hexamethylenediamine,124-09-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6790f142-425a-46ce-a232-f0d03685c74f/documents/d3edec2d-e9fe-487f-9e70-4f67ce7a0724_16d7c6da-884e-4a4e-bd47-6b2e7cc62541.html,,dermal,LD50,"1,900 mg/kg bw",, 1'-acetonaphthone,941-98-0," Repeated dose toxicity: Oral The No Observed Adverse Effect Level (NOAEL) for test substance was considered  to be <100 mg/Kg bw/ day in male rats. Repeated dose toxicity: Inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance methyl 1-naphthyl ketone (941-98-0) which is reported as 0.0003922823 mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical methyl 1-naphthyl ketone is highly unlikely. Therefore this study is considered for waiver. Repeated dose toxicity: Dermal The No Observed Adverse Effect level (NOAEL) for test chemical  was  considered to be 0.5mL (557.2 mg/kg) when applied to the clipped backs of guinea pigs. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/931dbe6e-9855-43af-9745-cf5c410b78ab/documents/fb993851-e255-4171-a209-bbbc62477a8d_7708c2d2-88fa-4757-88fb-93715e2462f2.html,,,,,, 1'-acetonaphthone,941-98-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/931dbe6e-9855-43af-9745-cf5c410b78ab/documents/fb993851-e255-4171-a209-bbbc62477a8d_7708c2d2-88fa-4757-88fb-93715e2462f2.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,557.2 mg/kg bw/day,,rabbit 1'-acetonaphthone,941-98-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/931dbe6e-9855-43af-9745-cf5c410b78ab/documents/fb993851-e255-4171-a209-bbbc62477a8d_7708c2d2-88fa-4757-88fb-93715e2462f2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 1'-acetonaphthone,941-98-0," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value isbetween 300-2000 mg/kg bw, for acute oral toxicity.Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity.  Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 5.23E-02 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats, rabbits and guinea pigs for the test chemical. The LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/931dbe6e-9855-43af-9745-cf5c410b78ab/documents/0daa24bb-7193-4f72-852b-5c11f1e9a12b_7708c2d2-88fa-4757-88fb-93715e2462f2.html,,,,,, 1'-acetonaphthone,941-98-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/931dbe6e-9855-43af-9745-cf5c410b78ab/documents/0daa24bb-7193-4f72-852b-5c11f1e9a12b_7708c2d2-88fa-4757-88fb-93715e2462f2.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, 1'-acetonaphthone,941-98-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/931dbe6e-9855-43af-9745-cf5c410b78ab/documents/0daa24bb-7193-4f72-852b-5c11f1e9a12b_7708c2d2-88fa-4757-88fb-93715e2462f2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-hexyl-1H-pyrazole-4,5-diamine sulfate (2:1)",1361000-03-4," Daily administration of 1-hexyl 4,5-diamine pyrazole sulfate by oral gavage to Sprague Dawley rats at a dose level of 20 mg/kg bw/day to males, and 8 and 20 mg/kg bw/day to females for 90 days resulted in minimal to mild decreases in red blood cell mass; no other toxicological significant or relevant findings were noted. The NOAEL is 5.0 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7dc2d8a-3b6e-44bd-9e39-817183bcbf0e/documents/022fe3bc-6c7e-47eb-85d5-ab1058c4afd7_94be5802-ac3c-47ac-9ca7-5116c245f37e.html,,,,,, "1-hexyl-1H-pyrazole-4,5-diamine sulfate (2:1)",1361000-03-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7dc2d8a-3b6e-44bd-9e39-817183bcbf0e/documents/022fe3bc-6c7e-47eb-85d5-ab1058c4afd7_94be5802-ac3c-47ac-9ca7-5116c245f37e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,, "1-hexyl-1H-pyrazole-4,5-diamine sulfate (2:1)",1361000-03-4," The acute oral toxicity of 1-HEXYL-1H-PYRAZOLE-4,5-DIAMINE HEMISULFATE was determined from a 28-day repeated dose finding study conducted using the dihydrochloride salt. The determined LD50, oral value of 218 mg/kg bw is considered conservative since none of the animals died at this dose and it was 10-fold lower than that of a structurally related chemical. It was also in accordance with the required test concentrations and possible LD50 estimations (between 50 and 300 mg/kg bw) for the OECD. Based on the calculated LD50 oral. value, 1-HEXYL-1H-PYRAZOLE-4,5-DIAMINE HEMISULFATE should be classified as Acute Tox Cat.3; H301: “toxic if swallowed”, according to the Globally Harmonized System of Classification and Labeling (GHS). Based on the available acute oral toxicity and toxicokinetics data for 1-HEXYL-1H-PYRAZOLE-4,5-DIAMINE HEMISULFATE, the acute dermal, as well as acute inhalation, toxic potential for 1-HEXYL-1H-PYRAZOLE-4,5-DIAMINE HEMISULFATE could be calculated. The calculated inhalation toxicity value (LC50, inhal.) for 1-HEXYL-1H-PYRAZOLE-4,5-DIAMINE HEMISULFATE is 2.51 mg/L. When this concentration is combined with the results of in vitro eye irritation studies, it can be concluded that the substance would not have a local effect in the lungs. The calculated LC50, inhal. is consistent with the measured value (in in vivo studies) for an analogue of 1-HEXYL-1H-PYRAZOLE-4,5-DIAMINE HEMISULFATE, namely 1-hydroxyethyl-4,5-diamino pyrazole sulphate. Based on the calculated LC50 inhal. value, 1-HEXYL-1H-PYRAZOLE-4,5-DIAMINE HEMISULFATE should be classified as Acute Tox Cat.3; H331: “toxic if inhaled”, according to the Globally Harmonized System of Classification and Labeling (GHS). As demonstrated by the toxicokinetics data, the bioavailability after application to the skin is lower than the oral bioavailability. The calculated acute dermal toxicity (LD50, dermal) of 1-HEXYL-1H-PYRAZOLE-4,5-DIAMINE HEMISULFATE is 1050 mg/kg bw. Therefore, it should be classified as Acute Tox Cat.4; H312: “harmful in contact with skin”, according to the Globally Harmonized System of Classification and Labeling (GHS). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7dc2d8a-3b6e-44bd-9e39-817183bcbf0e/documents/IUC5-7c550e4b-f068-4437-8687-bbefc1f92f7a_94be5802-ac3c-47ac-9ca7-5116c245f37e.html,,,,,, "1-hexyl-1H-pyrazole-4,5-diamine sulfate (2:1)",1361000-03-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7dc2d8a-3b6e-44bd-9e39-817183bcbf0e/documents/IUC5-7c550e4b-f068-4437-8687-bbefc1f92f7a_94be5802-ac3c-47ac-9ca7-5116c245f37e.html,,oral,LD50,218 mg/kg bw,adverse effect observed, "1-hexyl-1H-pyrazole-4,5-diamine sulfate (2:1)",1361000-03-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7dc2d8a-3b6e-44bd-9e39-817183bcbf0e/documents/IUC5-7c550e4b-f068-4437-8687-bbefc1f92f7a_94be5802-ac3c-47ac-9ca7-5116c245f37e.html,,dermal,LD50,"1,050 mg/kg bw",adverse effect observed, "1-hexyl-1H-pyrazole-4,5-diamine sulfate (2:1)",1361000-03-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7dc2d8a-3b6e-44bd-9e39-817183bcbf0e/documents/IUC5-7c550e4b-f068-4437-8687-bbefc1f92f7a_94be5802-ac3c-47ac-9ca7-5116c245f37e.html,,inhalation,LC50,2.51 mg/m3,adverse effect observed, 2-imino-1-methylimidazolidin-4-one,60-27-5," Due to legal reasons it is not justified to perform this studies. The substance is used solely for cosmetic uses. According to Directive 76/768/EEC (Cosmetics Directive) and in Regulation 1223/2009/EC (Cosmetics Regulation) it is not allowed to perform animal tests, although cosmetic raw materials are subject to restriction (marketing ban). Therefore the test on acute oral toxicity has to be waived. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09c5862a-13af-4602-b46d-878118c5f9f7/documents/9a18cf3c-dd7d-4493-b60d-12a0232168dd_fa6f5d01-7594-4628-806a-01f25554f9a7.html,,,,,, 1-naphthol,90-15-3," The repeated daily oral administration of 1-naphthol to rats for 13 weeks at 65, 130, or 400 mg/kg bw/day resulted in a number of altered urine and clinical chemistry parameters. However none of these findings were considered adverse. Microscopic, treatment-related changes were restricted to the stomach and spleen. In gastric tissues, squamous hyperplasia and hyperkeratosis of the nonglandular stomach were present in all males and most females given 400 mg/kg bw/day; and in both sexes at 130 mg/kg bw/day. At the high-dose level, gastric changes were moderate to severe and in both sexes given 130 mg/kg bw/day were minimal to mild. Treatment-related stomach or changes in spleen were not observed in rats at the 65 mg/kg bw/day group. The NOAEL was set at 130 mg/kg bw. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/573d56f7-d62e-4ad4-86ba-6d84fd06bdb6/documents/5b062f56-4457-4348-a6c1-0c1913128c64_75ab9b12-3af1-4d9b-ad6c-514d9ae15cdc.html,,,,,, 1-naphthol,90-15-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/573d56f7-d62e-4ad4-86ba-6d84fd06bdb6/documents/5b062f56-4457-4348-a6c1-0c1913128c64_75ab9b12-3af1-4d9b-ad6c-514d9ae15cdc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,130 mg/kg bw/day,,rat 1-naphthol,90-15-3, The LD50 by ingestion was estimated to be between 1000 to 2000 mg/kg bw. The LD50 by dermal exposure was estimated to be >880 mg/kg bw. The LC50 by inhalation exposure (dust) was estimated to > 97 mg/m3. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/573d56f7-d62e-4ad4-86ba-6d84fd06bdb6/documents/18e3bacc-08ea-405a-9fed-64266ce80d69_75ab9b12-3af1-4d9b-ad6c-514d9ae15cdc.html,,,,,, 1-naphthol,90-15-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/573d56f7-d62e-4ad4-86ba-6d84fd06bdb6/documents/18e3bacc-08ea-405a-9fed-64266ce80d69_75ab9b12-3af1-4d9b-ad6c-514d9ae15cdc.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, 1-naphthol,90-15-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/573d56f7-d62e-4ad4-86ba-6d84fd06bdb6/documents/18e3bacc-08ea-405a-9fed-64266ce80d69_75ab9b12-3af1-4d9b-ad6c-514d9ae15cdc.html,,dermal,LD50,880 mg/kg bw,adverse effect observed, 1-naphthol,90-15-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/573d56f7-d62e-4ad4-86ba-6d84fd06bdb6/documents/18e3bacc-08ea-405a-9fed-64266ce80d69_75ab9b12-3af1-4d9b-ad6c-514d9ae15cdc.html,,inhalation,LC50,97 mg/m3,no adverse effect observed, 1-nitropropane,108-03-2,"One sub-chronic oral study in Sprague-Dawley rats (28 day) which is a GLP guideline study. One sub-chronic inhalation study in Spraque-Dawley rats which is a GLP, OECD 422 study; a combined repeated inhalation exposure study wtih the reproduction/developmental screening test. One chronic inhalation study in male and female Long Evans Rats. Study duration was up to 21.5 months at 100 ppm 1-nitropropane. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a546818-82fe-4afa-8a12-960c8e2bc3f1/documents/IUC5-cc7fa7d5-79e1-44f9-bfe0-4ba4fe90abb5_d484f9a3-130c-463f-a560-853969a0e158.html,,,,,, 1-nitropropane,108-03-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a546818-82fe-4afa-8a12-960c8e2bc3f1/documents/IUC5-cc7fa7d5-79e1-44f9-bfe0-4ba4fe90abb5_d484f9a3-130c-463f-a560-853969a0e158.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat 1-nitropropane,108-03-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a546818-82fe-4afa-8a12-960c8e2bc3f1/documents/IUC5-cc7fa7d5-79e1-44f9-bfe0-4ba4fe90abb5_d484f9a3-130c-463f-a560-853969a0e158.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,91 mg/m3,,rat 1-nitropropane,108-03-2,Acute oral toxicity study of 1-nitropropane in the ratAcute dermal toxicity study in the rabbit.Acute inhalation toxicity study in the rat. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a546818-82fe-4afa-8a12-960c8e2bc3f1/documents/IUC5-1262abef-1b12-40fd-951e-d0a66c949cae_d484f9a3-130c-463f-a560-853969a0e158.html,,,,,, 1-nitropropane,108-03-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a546818-82fe-4afa-8a12-960c8e2bc3f1/documents/IUC5-1262abef-1b12-40fd-951e-d0a66c949cae_d484f9a3-130c-463f-a560-853969a0e158.html,,oral,LD50,506 mg/kg bw,, 1-nitropropane,108-03-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a546818-82fe-4afa-8a12-960c8e2bc3f1/documents/IUC5-1262abef-1b12-40fd-951e-d0a66c949cae_d484f9a3-130c-463f-a560-853969a0e158.html,,dermal,LD50,"2,000 mg/kg bw",, 1-nitropropane,108-03-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a546818-82fe-4afa-8a12-960c8e2bc3f1/documents/IUC5-1262abef-1b12-40fd-951e-d0a66c949cae_d484f9a3-130c-463f-a560-853969a0e158.html,,inhalation,LC50,"5,500 mg/m3",, "2,3,6-trimethylphenol",2416-94-6,Oral: NOAEL = 100 mg/kg bw; rat; OECD TG 407; GLP; K1 Inhalation: no data available Dermal: no data available ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2830815-4601-4faf-8a24-8af1c9e45a8b/documents/IUC5-c56971dc-d0ab-4bff-84f1-8c52c1b95bd1_e278f0b3-2de9-4c7d-88c4-0a7d941fd91d.html,,,,,, "2,3,6-trimethylphenol",2416-94-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2830815-4601-4faf-8a24-8af1c9e45a8b/documents/IUC5-c56971dc-d0ab-4bff-84f1-8c52c1b95bd1_e278f0b3-2de9-4c7d-88c4-0a7d941fd91d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2,3,6-trimethylphenol",2416-94-6,Oral: LD50 = 3600 mg/kg bw; rat; similar to OECD TG 401; pre-GLP; K2 Inhalation: discr. dose = 0.59 mg/L; rat; similar to OECD TG 403; pre-GLP; K2 Dermal: LD50 > 2000 mg/kg bw; rat; similar to OECD TG 402; non-GLP; K4 ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2830815-4601-4faf-8a24-8af1c9e45a8b/documents/IUC5-5eb377b7-90e4-4407-a113-954a4d1cc18c_e278f0b3-2de9-4c7d-88c4-0a7d941fd91d.html,,,,,, "2,3,6-trimethylphenol",2416-94-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2830815-4601-4faf-8a24-8af1c9e45a8b/documents/IUC5-5eb377b7-90e4-4407-a113-954a4d1cc18c_e278f0b3-2de9-4c7d-88c4-0a7d941fd91d.html,,oral,LD50,"3,600 mg/kg bw",adverse effect observed, "2,3,6-trimethylphenol",2416-94-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2830815-4601-4faf-8a24-8af1c9e45a8b/documents/IUC5-5eb377b7-90e4-4407-a113-954a4d1cc18c_e278f0b3-2de9-4c7d-88c4-0a7d941fd91d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,3,6-trimethylphenol",2416-94-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2830815-4601-4faf-8a24-8af1c9e45a8b/documents/IUC5-5eb377b7-90e4-4407-a113-954a4d1cc18c_e278f0b3-2de9-4c7d-88c4-0a7d941fd91d.html,,inhalation,discriminating conc.,0.59 mg/L,no adverse effect observed, "Butane-2,3-diol",513-85-9,"Oral: The acute oral LD50 was determined to be > 5000 mg/kg bw in rats. Inhalation: No mortality was observed in an inhalation risk test with a saturated vapor (LD50 > 0,85 mg/l) in rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60c58594-a48c-46b4-902a-f01c44800a27/documents/IUC5-e66b41bf-4d92-4ece-a0da-fabf162b183b_de5f2a85-0a67-47dc-95bd-5d21105e67ac.html,,,,,, "(2R,3S)-butane-2,3-diol",5341-95-7,"No study is available with the target substance. However, no toxic effects were observed in a 2-year feeding study in rats receiving up to 5000 mg/kg bw/day of the structural analogue substance butane-1,3-diol (CAS 107-88-0) (Celanese, 1963a, Scala and Paynter, 1967) and in a chronic feeding study in dogs receiving up to 750 mg/kg bw /day (Celanese, 1963b, Scala and Paynter, 1967). In a sub-chronic feeding study in dogs receiving the structural similar substance butane-1,3-diol (CAS 107-88-0) the NOAEL was 6000 mg/kg bw/day (Reuzel et al., 1978). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): limitations of the individual studies, but sufficient information for a WoE assessment ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd82bf60-28be-4448-8678-38359ab67383/documents/02b5acf0-f889-471f-b570-dce10eeaea22_6de063a2-9e64-4738-8bed-12e44c585c9b.html,,,,,, "(2R,3S)-butane-2,3-diol",5341-95-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd82bf60-28be-4448-8678-38359ab67383/documents/02b5acf0-f889-471f-b570-dce10eeaea22_6de063a2-9e64-4738-8bed-12e44c585c9b.html,Chronic toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat "(2R,3S)-butane-2,3-diol",5341-95-7,"No study is available on acute toxicity for the substance. However, adequate and reliable data are reported here for a structural analogue (source substance 2,3 -butandiol). Oral: The acute oral LD50 was determined to be > 5000 mg/kg bw in rats. Inhalation: No mortality was observed in an inhalation risk test with a saturated vapor (LD50 > 0,85 mg/L) in rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): sufficient for evaluation Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): sufficient for evaluation ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd82bf60-28be-4448-8678-38359ab67383/documents/adb74d70-c24f-4db6-baa1-3cb93af433d2_6de063a2-9e64-4738-8bed-12e44c585c9b.html,,,,,, "(2R,3S)-butane-2,3-diol",5341-95-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd82bf60-28be-4448-8678-38359ab67383/documents/adb74d70-c24f-4db6-baa1-3cb93af433d2_6de063a2-9e64-4738-8bed-12e44c585c9b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "(2R,3S)-butane-2,3-diol",5341-95-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd82bf60-28be-4448-8678-38359ab67383/documents/adb74d70-c24f-4db6-baa1-3cb93af433d2_6de063a2-9e64-4738-8bed-12e44c585c9b.html,,inhalation,LC50,850 mg/m3,no adverse effect observed, "(R,R)-(-)-butane-2,3-diol",24347-58-8," No toxic effects were observed in a 2-year feeding study in rats receiving up to 5000 mg 1,3-butylene glycol/kg bw /d (Celanese, 1963a, Scala and Paynter, 1967) and in a chronic feeding study in dogs receiving up to 750 mg/kg bw /d (Celanese, 1963b, Scala and Paynter, 1967). In a subchronic feeding study in dogs the NOAEL was 6000 mg/kg bw and day and the LOAEL 9000 mg/kg bw and day (Reuzel et al., 1978). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c30f3376-d070-44d6-afdf-6ed8ccf01456/documents/f91b9ef8-8ba5-4b5a-bfe5-b8fde8e0e008_ab12aeb1-f6cd-4a0d-aa48-429f235d1b14.html,,,,,, "(R,R)-(-)-butane-2,3-diol",24347-58-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c30f3376-d070-44d6-afdf-6ed8ccf01456/documents/f91b9ef8-8ba5-4b5a-bfe5-b8fde8e0e008_ab12aeb1-f6cd-4a0d-aa48-429f235d1b14.html,Chronic toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat "(R,R)-(-)-butane-2,3-diol",24347-58-8," Oral: The acute oral LD50 was determined to be > 5000 mg/kg bw in rats. Inhalation: No mortality was observed in an inhalation risk test with a saturated vapor (LD50 > 0,85 mg/l) in rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c30f3376-d070-44d6-afdf-6ed8ccf01456/documents/c48550a3-fab2-418b-8242-1c12c20bd647_ab12aeb1-f6cd-4a0d-aa48-429f235d1b14.html,,,,,, "(R,R)-(-)-butane-2,3-diol",24347-58-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c30f3376-d070-44d6-afdf-6ed8ccf01456/documents/c48550a3-fab2-418b-8242-1c12c20bd647_ab12aeb1-f6cd-4a0d-aa48-429f235d1b14.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "(R,R)-(-)-butane-2,3-diol",24347-58-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c30f3376-d070-44d6-afdf-6ed8ccf01456/documents/c48550a3-fab2-418b-8242-1c12c20bd647_ab12aeb1-f6cd-4a0d-aa48-429f235d1b14.html,,inhalation,LC50,850 mg/m3,no adverse effect observed, "2,3-dihydro-2,2,6-trimethylbenzaldehyde",116-26-7," Oral: NOAEL (rat): 125 mg/kg body weight per day ; male/female, OECD TG 422, 2020 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1c496f7-bd39-4ec3-985e-7c226e52dc54/documents/c3cbc97b-a9cd-4773-bba5-1ca82d454cf2_263a8fd3-4dfb-4f13-9f64-c2dbcb5181c3.html,,,,,, "2,3-dihydro-2,2,6-trimethylbenzaldehyde",116-26-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1c496f7-bd39-4ec3-985e-7c226e52dc54/documents/c3cbc97b-a9cd-4773-bba5-1ca82d454cf2_263a8fd3-4dfb-4f13-9f64-c2dbcb5181c3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "2,3-dihydro-2,2,6-trimethylbenzaldehyde",116-26-7," Oral: LD50 > 300 - < 2000 mg/kg bw, female rat, OECD TG 423, 2015 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1c496f7-bd39-4ec3-985e-7c226e52dc54/documents/1990f566-4852-4385-8c24-588cee7b79f9_263a8fd3-4dfb-4f13-9f64-c2dbcb5181c3.html,,,,,, "2,3-dihydro-2,2,6-trimethylbenzaldehyde",116-26-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1c496f7-bd39-4ec3-985e-7c226e52dc54/documents/1990f566-4852-4385-8c24-588cee7b79f9_263a8fd3-4dfb-4f13-9f64-c2dbcb5181c3.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "2,3-epoxypropyltrimethylammonium chloride",3033-77-0," The key repeated dose toxicity study was a 28-day oral (gavage) study conducted in male and female rats, with a further post-exposure period of 28 days (OECD 407). The study identified an LOAEL value of 3.16 mg/kg bw/day, based on effects to the kidney. The gonads and bone-marrow were also identified as main target organs. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82b7250c-73d5-4a88-9d76-d0555e2abd3e/documents/IUC5-ff4056a7-6669-41f2-8274-7ee26a28f13e_1ba72f0a-8532-4b85-b7a9-797c2ac77139.html,,,,,, "2,3-epoxypropyltrimethylammonium chloride",3033-77-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82b7250c-73d5-4a88-9d76-d0555e2abd3e/documents/IUC5-ff4056a7-6669-41f2-8274-7ee26a28f13e_1ba72f0a-8532-4b85-b7a9-797c2ac77139.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,3.16 mg/kg bw/day,,rat "2,3-epoxypropyltrimethylammonium chloride",3033-77-0," Annex VII requires only data for the oral route. The key oral study, conducted in a manner similar to (the now deleted) OECD 401 involved gavage administration of one of five doses of a 20% solution of EPTAC (diluted from 71.9% aqueous EPTAC as delivered) to male and female rats. An LD50 value of 1.34 ml/kg bw (or 1513 mg/kg bw) was reported for 71.9% EPTAC, equivalent to 1088 mg/kg bw for pure EPTAC. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82b7250c-73d5-4a88-9d76-d0555e2abd3e/documents/IUC5-3acb67fe-6752-48e7-9e42-cb39b248d79e_1ba72f0a-8532-4b85-b7a9-797c2ac77139.html,,,,,, "2,3-epoxypropyltrimethylammonium chloride",3033-77-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82b7250c-73d5-4a88-9d76-d0555e2abd3e/documents/IUC5-3acb67fe-6752-48e7-9e42-cb39b248d79e_1ba72f0a-8532-4b85-b7a9-797c2ac77139.html,,oral,LD50,"1,088 mg/kg bw",, "2,3-epoxypropyltrimethylammonium chloride",3033-77-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82b7250c-73d5-4a88-9d76-d0555e2abd3e/documents/IUC5-3acb67fe-6752-48e7-9e42-cb39b248d79e_1ba72f0a-8532-4b85-b7a9-797c2ac77139.html,,dermal,LD50,"1,600 mg/kg bw",, "Naphthalene-2,3-diol",92-44-4,"Acute Oral Toxicity The  acute  oral  median  lethal  dose  (LD50)  of  the  test  material  in  the  female Sprague-Dawley CD strain rat was estimated to be in the range of 300 - 500 mg/kg bodyweight. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): K1 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58b7c76a-64cd-428b-a257-fa1a96ac424f/documents/8d432cff-52d1-48f5-9bf2-c6e4de588667_b1d317fd-bdaa-49a7-b70b-cde40207d813.html,,,,,, "Naphthalene-2,3-diol",92-44-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58b7c76a-64cd-428b-a257-fa1a96ac424f/documents/8d432cff-52d1-48f5-9bf2-c6e4de588667_b1d317fd-bdaa-49a7-b70b-cde40207d813.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "2,3-xylenol",526-75-0,"Acute toxicity: Oral LD50 was estimated to be 790 mg/kg bw when rat were orally exposed with 2,3-dimethylphenol.   Acute toxicity: Inhalation LD50 was considered to be > 85.5 mg/m3when Fischer 344 male rat were exposed to saturated vapors of 2,3-dimethylphenol for 4 h.   Acute toxicity: dermal LD50 was estimated to be 987 mg/kg bw when Vienna White male and female rabbit were dermally exposed with 2,3-dimethylphenol.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/338e7b7f-f85e-4032-a196-a88fc241c296/documents/f078c98b-9693-4bf8-bb65-e575a400a7b3_7780b10c-2965-4a9a-85bd-3ce632a1296c.html,,,,,, "2,3-xylenol",526-75-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/338e7b7f-f85e-4032-a196-a88fc241c296/documents/f078c98b-9693-4bf8-bb65-e575a400a7b3_7780b10c-2965-4a9a-85bd-3ce632a1296c.html,,oral,LD50,790 mg/kg bw,adverse effect observed, "2,3-xylenol",526-75-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/338e7b7f-f85e-4032-a196-a88fc241c296/documents/f078c98b-9693-4bf8-bb65-e575a400a7b3_7780b10c-2965-4a9a-85bd-3ce632a1296c.html,,dermal,LD50,987 mg/kg bw,adverse effect observed, "2,3-xylenol",526-75-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/338e7b7f-f85e-4032-a196-a88fc241c296/documents/f078c98b-9693-4bf8-bb65-e575a400a7b3_7780b10c-2965-4a9a-85bd-3ce632a1296c.html,,inhalation,LC50,85.5 mg/m3,no adverse effect observed, "2-(2,4-diaminophenoxy)ethanol dihydrochloride",66422-95-5,"The test substance 2,4-diaminophenoxyethanol dihydrochloride was administered daily by gavage to Sprague-Dawley rats at the dose level of 4, 20 or 100 mg/kg bw/day for 13 weeks. At 4 and 20 mg/kg bw/day the test item was well tolerated. A 100 mg/kg bw/day, ptyalism was observed in both males and females and lower body weight gains were noted for males. Presence of urinary bilirubin, nitrites, glucose and coloured urine in both males and females was observed at the end of the treatment period. After a 4 week treatment-free period, all the above-mentioned changes were no longer noted. Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg bw/day on completion of treatment and treatment-free periods. Under the experimental conditions of the study, the NOEL is established to be 20 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ff4de6f-12d2-4d20-8ec2-27230eaa4474/documents/IUC5-14c23952-6da1-4b55-b090-688c39536dba_338dbed2-3ce5-41ab-8256-998babf968c1.html,,,,,, "2-(2,4-diaminophenoxy)ethanol dihydrochloride",66422-95-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ff4de6f-12d2-4d20-8ec2-27230eaa4474/documents/IUC5-14c23952-6da1-4b55-b090-688c39536dba_338dbed2-3ce5-41ab-8256-998babf968c1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "2-(2,4-diaminophenoxy)ethanol dihydrochloride",66422-95-5," Under the experimental conditions, the LD50 of the test item was close to 1000 mg/kg bw since a single dose of 1000 mg/kg induced death in 1/5 male and 3/5 female rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ff4de6f-12d2-4d20-8ec2-27230eaa4474/documents/IUC5-858aa5e1-ab83-40d3-bb1a-83ba2a7d7f18_338dbed2-3ce5-41ab-8256-998babf968c1.html,,,,,, "2-(2,4-diaminophenoxy)ethanol dihydrochloride",66422-95-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ff4de6f-12d2-4d20-8ec2-27230eaa4474/documents/IUC5-858aa5e1-ab83-40d3-bb1a-83ba2a7d7f18_338dbed2-3ce5-41ab-8256-998babf968c1.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, "[4-(2-hydroxyethoxy)-1,3-phenylene]diammonium sulphate",70643-20-8,"The test substance 2,4-diaminophenoxyethanol dihydrochloride was administered daily by gavage to Sprague-Dawley rats at the dose level of 4, 20 or 100 mg/kg bw/day for 13 weeks. At 4 and 20 mg/kg bw/day the test item was well tolerated. A 100 mg/kg bw/day, ptyalism was observed in both males and females and lower body weight gains were noted for males. Presence of urinary bilirubin, nitrites, glucose and coloured urine in both males and females was observed at the end of the treatment period. After a 4 week treatment-free period, all the above-mentioned changes were no longer noted. Deposition of brownish pigment in the thyroids and an augmented degree of spleen hemosiderosis were also observed for most animals given 100 mg/kg bw/day on completion of treatment and treatment-free periods. Under the experimental conditions of the study, the NOAEL is established to be 20 mg/kg bw/day. For the purpose of REACH registration, read across with the analogue substance 2-(2,4-diaminophenoxy)ethanol dihydrochloride appears appropriate. A NOAEL of 25 mg/kg bw/day is calculated for 2,4 -diaminophenoxyethanol sulphate dihydrate. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe016723-03ac-4bf8-ae53-6bf22d16dc7a/documents/IUC5-0af75833-1211-4f13-8726-04d550ea2b77_08aa9fcd-dda6-46e8-b583-22a93976608f.html,,,,,, "[4-(2-hydroxyethoxy)-1,3-phenylene]diammonium sulphate",70643-20-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe016723-03ac-4bf8-ae53-6bf22d16dc7a/documents/IUC5-0af75833-1211-4f13-8726-04d550ea2b77_08aa9fcd-dda6-46e8-b583-22a93976608f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat "[4-(2-hydroxyethoxy)-1,3-phenylene]diammonium sulphate",70643-20-8,"For the purpose of REACH registration, read across with the analogue substance 2-(2,4-diaminophenoxy)ethanol dihydrochloride appears appropriate. Under the experimental conditions, the LD50 of the test item was close to 1000 mg/kg bw since a single dose of 1000 mg/kg induced death in 1/5 male and 3/5 female rats. Based on the available data for 2-(2,4-diaminophenoxy)ethanol dihydrochloride the acute oral toxicity of 2-(2,4-diaminophenoxy)ethanol sulphate is calculated to be 1104 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe016723-03ac-4bf8-ae53-6bf22d16dc7a/documents/IUC5-bb775876-de95-47f3-a1a4-e4f94c1e45cf_08aa9fcd-dda6-46e8-b583-22a93976608f.html,,,,,, "[4-(2-hydroxyethoxy)-1,3-phenylene]diammonium sulphate",70643-20-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe016723-03ac-4bf8-ae53-6bf22d16dc7a/documents/IUC5-bb775876-de95-47f3-a1a4-e4f94c1e45cf_08aa9fcd-dda6-46e8-b583-22a93976608f.html,,oral,LD50,"1,104 mg/kg bw",adverse effect observed, "2,4-dimethylcyclohex-3-ene-1-methyl acetate",67634-26-8,Acute oral toxicity (based on read across from Iso cyclo geraniol): LD50 > 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f85ef80a-068e-46de-9f67-02db4fe448b5/documents/70d9990f-783e-491b-8d91-fdb38284ca70_ef903e71-7912-425c-bdc7-c7ee6f3bd511.html,,,,,, "2,4-dimethyl-4-phenyltetrahydrofuran",82461-14-1," A Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD Guideline 422) was performed. - NOAEL for F0 male and female reproductive and systemic toxicity: 600 mg/kg bw/day, based on a lack of adverse findings noted during the premating period or on neurobehavior, motor activity, and pathology parameters and based on no effects on male or female reproductive indices at any dose level (OECD 422 - oral gavage, GLP, Rel.1) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/520a3e41-954b-4075-b43c-cd952178664b/documents/ef90cd88-c50b-4e5b-a5c6-5aa1b4f9431e_49b18163-06f0-46c9-9ecf-b55455f47cc6.html,,,,,, "2,4-dimethyl-4-phenyltetrahydrofuran",82461-14-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/520a3e41-954b-4075-b43c-cd952178664b/documents/ef90cd88-c50b-4e5b-a5c6-5aa1b4f9431e_49b18163-06f0-46c9-9ecf-b55455f47cc6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat "2,4-dimethyl-4-phenyltetrahydrofuran",82461-14-1," Oral Oral LD50 = 3980 mg/kg bw (eq. to OECD 401, K, Rel.2, Standard acute Method) Oral LD50 < 4960 mg/kg bw (eq. to OECD 401, S, Rel.4, Standard acute Method) Inhalation Waiver (exposure considerations) Dermal Waiver (study scientifically not necessary) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/520a3e41-954b-4075-b43c-cd952178664b/documents/45acd02e-2349-4577-90fc-82c5208cbdd4_49b18163-06f0-46c9-9ecf-b55455f47cc6.html,,,,,, "2,4-dimethyl-4-phenyltetrahydrofuran",82461-14-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/520a3e41-954b-4075-b43c-cd952178664b/documents/45acd02e-2349-4577-90fc-82c5208cbdd4_49b18163-06f0-46c9-9ecf-b55455f47cc6.html,,oral,LD50,"3,980 mg/kg bw",adverse effect observed, "2,4-xylenol",105-67-9,"Based on the results, the NOAEL of 180 mg/kg bw/day from the 90-day study in rats has been considered further for the hazard/risk assessment. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a01578d8-a3d6-4160-b0c6-29f407c45619/documents/e0dfecfe-2400-4cce-a7de-dc1be6b891d6_cb6ec5ae-f196-4a0e-8ed1-0bed4fe36822.html,,,,,, "2,4-xylenol",105-67-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a01578d8-a3d6-4160-b0c6-29f407c45619/documents/e0dfecfe-2400-4cce-a7de-dc1be6b891d6_cb6ec5ae-f196-4a0e-8ed1-0bed4fe36822.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,> 240 mg/kg bw/day,,rat "2,4-xylenol",105-67-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a01578d8-a3d6-4160-b0c6-29f407c45619/documents/e0dfecfe-2400-4cce-a7de-dc1be6b891d6_cb6ec5ae-f196-4a0e-8ed1-0bed4fe36822.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,180 mg/kg bw/day,,rat "2,4-xylenol",105-67-9,"The oral LD50 value of the test substance was 3200 mg/kg bw/day based on a literature source (BG RCI, 2005) and has also been classified as corrosive under harmonized classfication. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a01578d8-a3d6-4160-b0c6-29f407c45619/documents/7dd14520-5d47-4691-a7c5-05731c2b9888_cb6ec5ae-f196-4a0e-8ed1-0bed4fe36822.html,,,,,, "2,4-xylenol",105-67-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a01578d8-a3d6-4160-b0c6-29f407c45619/documents/7dd14520-5d47-4691-a7c5-05731c2b9888_cb6ec5ae-f196-4a0e-8ed1-0bed4fe36822.html,,oral,LD50,"3,200 mg/kg bw",adverse effect observed, "2,5,6-trimethylcyclohex-2-en-1-one",20030-30-2,"repeated dose toxicity:- oral: subacute: 28 day (rat, OECD 407) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab3002e8-1329-4f3a-965c-bef9b531901e/documents/IUC5-22df0081-d19f-4ea3-8bce-4a2e0e1130e7_1ee6de72-5836-4268-8317-2d0f28e05eba.html,,,,,, "2,5,6-trimethylcyclohex-2-en-1-one",20030-30-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab3002e8-1329-4f3a-965c-bef9b531901e/documents/IUC5-22df0081-d19f-4ea3-8bce-4a2e0e1130e7_1ee6de72-5836-4268-8317-2d0f28e05eba.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,300 mg/kg bw/day,, "2,5,6-trimethylcyclohex-2-en-1-one",20030-30-2,"Acute Toxicity- oral: LD50 = 1866 mg/kg bw (rat)- inhalative: LC50 = 20.55 mg/l (8h, rat)- ip: LD50 = 243 mg/kg bw (mouse) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab3002e8-1329-4f3a-965c-bef9b531901e/documents/IUC5-f59e3efd-a6f1-4cae-8e01-b4fc98074493_1ee6de72-5836-4268-8317-2d0f28e05eba.html,,,,,, "2,5,6-trimethylcyclohex-2-en-1-one",20030-30-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab3002e8-1329-4f3a-965c-bef9b531901e/documents/IUC5-f59e3efd-a6f1-4cae-8e01-b4fc98074493_1ee6de72-5836-4268-8317-2d0f28e05eba.html,,oral,LD50,"1,866 mg/kg bw",, "2,5-xylenol",95-87-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c6a5f0d-9575-4656-b8a1-abe84260736e/documents/7586096c-f7ab-466e-aa94-c876c944197c_947ce7a7-099f-49a4-985f-2beb04d06e8b.html,,oral,LD50,444 mg/kg bw,adverse effect observed, "Pyridine-2,6-dicarboxylic acid",499-83-2, Assessment of acute toxicity or its classification is not warranted as the substance is classified as skin corrosive 1A according to the EU CLP (1272/2008) criteria. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f472d580-874b-478b-9730-d2c0c89aaa4f/documents/738b3750-f7bc-4830-938c-7a60f2bf56c9_a941f921-0ad0-443a-a5f0-dd5379fcab49.html,,,,,, "2,6-dimethylheptan-4-one",108-83-8, DIBK: A non-GLP oral repeated dose (90d) toxicity study using rats 2 non-GLP 6 week inhalation studies (rat and guinea pig) A non-GLP 9 -day vapour inhalation study in rats A non-GLP 14 -day inhalation study in rats a non-GLP 10 -day dermal study in guinea pigs Data on category members MIBK: A GLP 90 -day oral repeated dose study in rats 2 GLP Chronic toxicity/carcinogenicity studies via inhalation in rats and mice ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d9f59047-ecb5-4705-8bfc-7d82d6e397ca/documents/f2843d02-f7c0-4d71-a5fe-75ef5af3d738_e1ce1726-fcc8-4195-80b2-97ba79906327.html,,,,,, "2,6-dimethylheptan-4-one",108-83-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d9f59047-ecb5-4705-8bfc-7d82d6e397ca/documents/f2843d02-f7c0-4d71-a5fe-75ef5af3d738_e1ce1726-fcc8-4195-80b2-97ba79906327.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"2,650 mg/m3",,rat "2,6-dimethylheptan-4-one",108-83-8, A GLP-study according to OECD guideline 401 and several non-GLP studies equivalent or similar to OECD guidelines 401 and 403 are available for diisobutyl ketone (DIBK). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9f59047-ecb5-4705-8bfc-7d82d6e397ca/documents/7d686732-f015-45e1-bd02-c43de31b9670_e1ce1726-fcc8-4195-80b2-97ba79906327.html,,,,,, "2,6-dimethylheptan-4-one",108-83-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9f59047-ecb5-4705-8bfc-7d82d6e397ca/documents/7d686732-f015-45e1-bd02-c43de31b9670_e1ce1726-fcc8-4195-80b2-97ba79906327.html,,oral,LD50,"5,233 mg/kg bw",adverse effect observed, "2,6-dimethylheptan-4-one",108-83-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9f59047-ecb5-4705-8bfc-7d82d6e397ca/documents/7d686732-f015-45e1-bd02-c43de31b9670_e1ce1726-fcc8-4195-80b2-97ba79906327.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,6-dimethylheptan-4-one",108-83-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9f59047-ecb5-4705-8bfc-7d82d6e397ca/documents/7d686732-f015-45e1-bd02-c43de31b9670_e1ce1726-fcc8-4195-80b2-97ba79906327.html,,inhalation,LC50,"14,500 mg/m3",adverse effect observed, "2,6-dimethyloct-7-en-2-ol",18479-58-8,"In a GLP compliant subchronic oral toxicity study with the analogue substance dimyrcetol according to OECD guideline 408, the NOAEL was found to be 500 mg/kg bw/day in male and female rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc933fc2-4b01-40a8-a113-23293629c4e3/documents/IUC5-4a97f518-57f4-46dc-9952-0818fa19ceb0_b5d1e072-0c37-4552-8cfd-3451ddfbc4ea.html,,,,,, "2,6-dimethyloct-7-en-2-ol",18479-58-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc933fc2-4b01-40a8-a113-23293629c4e3/documents/IUC5-4a97f518-57f4-46dc-9952-0818fa19ceb0_b5d1e072-0c37-4552-8cfd-3451ddfbc4ea.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "2,6-dimethyloct-7-en-2-ol",18479-58-8,"In an acute oral toxicity study in male and female rats, the LD50 was found to be 3020 mg/kg bw in bot sexes. In an acute oral toxicity study in rats with the analogue chemical Dimyrcetol, the LD50 was found to be 4100 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc933fc2-4b01-40a8-a113-23293629c4e3/documents/IUC5-06e7841f-304d-4aef-900e-b8589be533ea_b5d1e072-0c37-4552-8cfd-3451ddfbc4ea.html,,,,,, "2,6-dimethyloct-7-en-2-ol",18479-58-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc933fc2-4b01-40a8-a113-23293629c4e3/documents/IUC5-06e7841f-304d-4aef-900e-b8589be533ea_b5d1e072-0c37-4552-8cfd-3451ddfbc4ea.html,,oral,LD50,"3,020 mg/kg bw",no adverse effect observed, "2,6-dimethylheptan-2-ol",13254-34-7," Dimetol was administered by diet to male and female Wistar Han rats at dose levels of 1000, 3000 and 10000 ppm. Males were exposed for 2 weeks prior to mating, during mating, and up to termination (for 29 days). The females were exposed for 2 weeks prior to mating, during mating, during postcoitum, and at least 4 days of lactation (for 39-57 days). Diet preparation analysis showed that the diets were prepared accurately and were homogenous. Parental results: Parental toxicity was evident at 10000 ppm and was characterized by lower body weight gains for males Day 8 of the premating period onwards. Palatability issues of the test diet likely contributed to the lower gains as food consumption was lower during the first week of treatment. Males and females at this dose level had higher absolute and relative liver weights with relative liver weights approximately 16% and 20% higher for males and females than controls, respectively. At the microscopic examination, cortical hyaline droplets representing alpha2uglobulin were recorded at an increased incidence and severity in the kidneys of males treated at 10000 ppm. These changes resulted from the increased/altered liver metabolism resulting in excessive accumulation of alpha- 2uglobulin in the renal proximal tubular epithelial cells and are regarded as specific to the male rat. Alpha-2uglobulin does not occur in the human kidney and that this finding does not indicate any potential risk to human health. This was accompanied by an increased incidence and severity of corticomedullary tubular basophilia and in one instance by granular casts. These granular casts are considered to be indicative of primary tubular injury and therefore this finding was considered to be adverse. There were no relevant microscopic findings noted for females at 10000 ppm. No treatment-related changes were noted in any of the remaining parental parameters investigated in this study (i.e. clinical appearance, functional observations, clinical laboratory investigations and macroscopic examination). Reproductive results: No reproductive toxicity was observed up to the highest dose level tested (10000 ppm). Developmental results: No developmental toxicity was observed up to the highest dose level tested (10000 ppm). In conclusion, treatment with Dimetol by dietary administration in male and female Wistar Han rats at dose levels of 1000, 3000 and 10000 ppm revealed parental toxicity at 10000 ppm. No reproductive or developmental toxicity was observed for treatment up to 10000 ppm. Based on these results, a parental No Observed Adverse Effect Level (NOAEL) of 3000 ppm was determined and a reproductive and developmental NOAEL of at least 10000 ppm was derived. When corrected for mean test article intake, the parental NOAEL of 3000 ppm corresponds to 228-231 mg/kg for males and 251-382 mg/kg for females. The reproductive and developmental NOAEL of 10000 ppm corresponds to 714-734 mg/kg for males and 830-1216 mg/kg for females. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/437b9200-3406-4548-ae9e-3e45b101c319/documents/a332bafd-1ee5-4ab5-98d1-44ce8b51b183_6b301b15-d412-496a-a18f-829d19205dd1.html,,,,,, "2,6-dimethylheptan-2-ol",13254-34-7," Acute Inhalation Toxicity In line with Column 2, point 8.5.2, Annex VIII of Regulation 1907/2006, an acute inhalation study does not need to be performed as the substance has a low vapour pressure and the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. The acute toxicity endpoint has been addressed by assessing the toxicity via the oral , which is more appropriate when considering the properties of this substance. Acute Dermal Toxicity In line with section 1.1, Annex XI of Regulation 1907/2006, an acute dermal toxicity study does not need to be per-formed as use of existing data, from the supporting study, indicates that the substance it likely to have an LD50 above the limits of classification for acute dermal toxicity. Acute Oral Toxicity The acute oral toxicity in rats was determined to be 2000 mg/kg using a weight of the evidence approach considering two pre-GLP studies. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/437b9200-3406-4548-ae9e-3e45b101c319/documents/2cb717b0-546e-43cb-811d-f97884b51773_6b301b15-d412-496a-a18f-829d19205dd1.html,,,,,, "2,6-xylenol",576-26-1,ORAL A 28 day repeated dose/reprotoxicity study was carried out in rats in accordance with OECD 422 on a structural analogue of the registered material. The NOAEL was deemed to be greater than or equal to 200 mg/kg/day.   INHALATION A 14 day repeated dose inhalation study was carried out in rats. The NOAEC was deemed to be 200 mg/m³.   ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7600729-9c4a-4e67-851a-13ca05a1aff4/documents/IUC5-4ae2dd22-834c-48ad-b690-d7eb164d07fa_fc5ad40f-225d-4a50-a3b0-0d42397771a9.html,,,,,, "2,6-xylenol",576-26-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7600729-9c4a-4e67-851a-13ca05a1aff4/documents/IUC5-4ae2dd22-834c-48ad-b690-d7eb164d07fa_fc5ad40f-225d-4a50-a3b0-0d42397771a9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "2,6-xylenol",576-26-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7600729-9c4a-4e67-851a-13ca05a1aff4/documents/IUC5-4ae2dd22-834c-48ad-b690-d7eb164d07fa_fc5ad40f-225d-4a50-a3b0-0d42397771a9.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,200 mg/m3,,rat "2,6-xylenol",576-26-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7600729-9c4a-4e67-851a-13ca05a1aff4/documents/IUC5-4ae2dd22-834c-48ad-b690-d7eb164d07fa_fc5ad40f-225d-4a50-a3b0-0d42397771a9.html,Repeated dose toxicity – local effects,inhalation,NOAEC,200 mg/m3,adverse effect observed,rat "2,6-xylenol",576-26-1,ORAL Key study: An acute oral study was performed using methodology similar to that outlined in OECD 401 and identified an LD50 in rats of 1470 mg/kg. Supporting study: An acute oral study was performed to an unknown method and provided an LD50 of 296 mg/kg bw in the rat.   INHALATION Waived (substance is corrosive)   DERMAL Waived (substance is corrosive) Supporting study: Study with limited reporting provided an LD50 of 1000 mg/kg in the rabbit  ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7600729-9c4a-4e67-851a-13ca05a1aff4/documents/IUC5-acf11ca5-f1a5-4a43-aec8-c7e510416759_fc5ad40f-225d-4a50-a3b0-0d42397771a9.html,,,,,, "2,6-xylenol",576-26-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7600729-9c4a-4e67-851a-13ca05a1aff4/documents/IUC5-acf11ca5-f1a5-4a43-aec8-c7e510416759_fc5ad40f-225d-4a50-a3b0-0d42397771a9.html,,oral,LD50,"1,470 mg/kg bw",adverse effect observed, "Naphthalene-2,7-diol",582-17-2,"The method used is not intended to allow the calculation of a precise LD50 value. The test item was ranked into classes of Globally Harmonized Classification System (GHS) LD50 between 300 and 2000 mg/kg bw GHS Category 4 Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): K1 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a397f8fd-7383-4124-a85b-c5a97f24d9f6/documents/50fb7fae-53cd-4417-99b5-37f6ecafb0a8_d684383e-60c7-4d3d-bc4b-daa0c775c760.html,,,,,, "Naphthalene-2,7-diol",582-17-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a397f8fd-7383-4124-a85b-c5a97f24d9f6/documents/50fb7fae-53cd-4417-99b5-37f6ecafb0a8_d684383e-60c7-4d3d-bc4b-daa0c775c760.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, 2-(2-aminoethoxy)ethanol,929-06-6,"Subchronic dermal and oral as well as subacute inhalative data are available for the determination of the repeated dose toxicity: oral Under the conditions of an OECD 422 combined repeated dose toxicity study with the reproductive/developmental screening test in Wistar rats, the no observed adverse effect level (NOAEL) for general systemic toxicity, fertility and reproductive performance and for developmental toxicity in the offspring was 15000 ppm for male (about 793 mg/kg bw/d) and female (about 1175 mg/kg bw/d) Wistar rats, the highest concentration tested. The study was performed as a dose-range-finding-study before an OECD 443. In the subsequent oral extended one-generation reproduction toxicity study (OECD 443) the NOAEL for general, systemic toxicity is 340 mg/kg bw/d, based on clinical signs of toxicity and mortality during lactation, in the F0 parental animals as well as adolescent and adult F1 offspring.   inhalation In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422) the no observed adverse effect concentration (NOAEC) for general systemic toxicity as well as reproductive performance, fertility and developmental toxicity in male and female Wistar rats was 40 mg/m³. The NOAEC for local signs of toxicity in male and female Wistar rats was 4 mg/m³.   dermal In a subchronic dermal study following OECD test guideline 411 dermal irritation was noted at the lowest dose tested (17 mg/kg/day). The NOAEL for systemic toxicity was determined to be 175 mg/kg/day (highest dose tested). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e176e43a-b4b3-4026-aa87-213263548f40/documents/IUC5-592f72fa-c5f6-460d-bfbd-f28b55494fde_4486fca7-46c5-4b7f-b05b-e5b1d71852e1.html,,,,,, 2-(2-aminoethoxy)ethanol,929-06-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e176e43a-b4b3-4026-aa87-213263548f40/documents/IUC5-592f72fa-c5f6-460d-bfbd-f28b55494fde_4486fca7-46c5-4b7f-b05b-e5b1d71852e1.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,40 mg/m3,,rat 2-(2-aminoethoxy)ethanol,929-06-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e176e43a-b4b3-4026-aa87-213263548f40/documents/IUC5-592f72fa-c5f6-460d-bfbd-f28b55494fde_4486fca7-46c5-4b7f-b05b-e5b1d71852e1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,340 mg/kg bw/day,,rat 2-(2-aminoethoxy)ethanol,929-06-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e176e43a-b4b3-4026-aa87-213263548f40/documents/IUC5-592f72fa-c5f6-460d-bfbd-f28b55494fde_4486fca7-46c5-4b7f-b05b-e5b1d71852e1.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,175 mg/kg bw/day,,rat 2-(2-aminoethoxy)ethanol,929-06-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e176e43a-b4b3-4026-aa87-213263548f40/documents/IUC5-592f72fa-c5f6-460d-bfbd-f28b55494fde_4486fca7-46c5-4b7f-b05b-e5b1d71852e1.html,Repeated dose toxicity – local effects,dermal,NOAEL,17 ,adverse effect observed,rat 2-(2-aminoethoxy)ethanol,929-06-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e176e43a-b4b3-4026-aa87-213263548f40/documents/IUC5-592f72fa-c5f6-460d-bfbd-f28b55494fde_4486fca7-46c5-4b7f-b05b-e5b1d71852e1.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4 mg/m3,adverse effect observed,rat 2-(2-aminoethoxy)ethanol,929-06-6,"Acute Toxicity:- LD50 (oral, rat) = 3400kg/kg bw (BASF, 1969)- LC50 (inhalation, rat) > 8,7 mg/m3 (BASF, 1969)- LD50 (dermal, rabbit) > 3000 mg/kg bw (Huntsman, 1991) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e176e43a-b4b3-4026-aa87-213263548f40/documents/IUC5-a515b4d6-1069-4a54-8a12-b988542d91a4_4486fca7-46c5-4b7f-b05b-e5b1d71852e1.html,,,,,, 2-(2-aminoethoxy)ethanol,929-06-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e176e43a-b4b3-4026-aa87-213263548f40/documents/IUC5-a515b4d6-1069-4a54-8a12-b988542d91a4_4486fca7-46c5-4b7f-b05b-e5b1d71852e1.html,,oral,LD50,"3,400 mg/kg bw",no adverse effect observed, 2-(2-aminoethoxy)ethanol,929-06-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e176e43a-b4b3-4026-aa87-213263548f40/documents/IUC5-a515b4d6-1069-4a54-8a12-b988542d91a4_4486fca7-46c5-4b7f-b05b-e5b1d71852e1.html,,dermal,LD50,"> 3,000 mg/kg bw",no adverse effect observed, 2-(2-aminoethoxy)ethanol,929-06-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e176e43a-b4b3-4026-aa87-213263548f40/documents/IUC5-a515b4d6-1069-4a54-8a12-b988542d91a4_4486fca7-46c5-4b7f-b05b-e5b1d71852e1.html,,inhalation,LC50,> 8.7 mg/m3,no adverse effect observed, 2'-acetonaphthone,93-08-3," Repeated dose toxicity: Oral A 90-day repeated dose toxicity study was performed to investigate the toxic nature of 1-(2-naphthyl)ethanone in 15 male and 15 female rats of the FDRL strain. The test chemical was diluted in cotton seed oil in a concentration sufficient to provide the predetermined dosage in 2% of the diet. The daily consumption of the test chemical was 33 mg/kg body weight/day for males and 36.9 mg/kg body weight/day for females. The individual body weight and food consumption was recorded during the administrating period. In addition, haematological and blood chemical determinations were made on 8 rats of each sex at a 6-week period, and in all rats at 12 weeks. The tests were terminated at 90 days and at autopsy, liver and kidney weights were recorded. The following organs from half the animals in each group were taken for histological examination: liver, kidneys, stomach, small and large intestines, spleen, pancreas, heart, lungs, bone marrow, muscle, brain, spinal cord, bladder, adrenals, thyroid, pituitary, gonads, salivary glands, and lymph nodes. Measurements of growth, haematological and blood clinical chemical analysis, gross and histological examination of the major organs revealed no significant adverse effects, related to the test chemical administration. Hence, the repeated exposure to 1-(2-naphthyl)ethenone up to concentration of 33 and 36.9 mg/kg body weight/day exerted no specific target organ toxicity when administered in feed to rats for 90 days.The NOAEL (No Observed Adverse Effect Level ) of the test chemical was considered to be 33 mg/kg body weigh/day for males and 36.9 mg/kg body weight/day for females. Repeated dose toxicity: Inhalation 2'-acetonaphthone (CAS no 93-08-3) has very low vapor pressure of 0.0009 mm Hg at 21.9°C. So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely. Also, the particle size distribution was determined in the range of 500 micrometer to 1000 micron.Therefore this end point for repeated dose toxicity by inhalation route is considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value for2'-acetonaphthone (CAS no 93-08-3)(as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ffe2824-c755-472b-81aa-d340eb0b83c6/documents/361529b3-e2b3-4c02-a36b-f6be7ec2eca2_a5151ebc-ff0a-4b42-84d9-2bded8446220.html,,,,,, 2'-acetonaphthone,93-08-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ffe2824-c755-472b-81aa-d340eb0b83c6/documents/361529b3-e2b3-4c02-a36b-f6be7ec2eca2_a5151ebc-ff0a-4b42-84d9-2bded8446220.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,33 mg/kg bw/day,,rat 2'-acetonaphthone,93-08-3," Acute oral toxicity:    The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The median lethal dose LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified as´Not classified ´.   Acute Inhalation Toxicity:   The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0009 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity:   The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that median lethal dose LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ffe2824-c755-472b-81aa-d340eb0b83c6/documents/74e80d2e-7f4b-4899-a342-6d73611c0f10_a5151ebc-ff0a-4b42-84d9-2bded8446220.html,,,,,, 2'-acetonaphthone,93-08-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ffe2824-c755-472b-81aa-d340eb0b83c6/documents/74e80d2e-7f4b-4899-a342-6d73611c0f10_a5151ebc-ff0a-4b42-84d9-2bded8446220.html,,oral,LD50,"2,300 mg/kg bw",no adverse effect observed, 2'-acetonaphthone,93-08-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ffe2824-c755-472b-81aa-d340eb0b83c6/documents/74e80d2e-7f4b-4899-a342-6d73611c0f10_a5151ebc-ff0a-4b42-84d9-2bded8446220.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, (3-ammonio-4-methoxyphenyl)(2-hydroxyethyl)ammonium sulphate,83763-48-8," The registered substance 2-amino-4-hydroxyethylaminoanisole sulfate was evaluated on two tests by two different routes of exposure : one oral and one dermal, for potential subchronic toxicity (OECD Guideline 408 90 Days oral method, GLP compliant, Klimisch 1) (OECD Guideline 410 28 days dermal method, GLP compliant, Klimisch 1). The No Observed Adverse Level (NOAEL) was defined as 300 mg/kg/day for dermal route and as 15 mg/kg/day for oral route (gavage). According to results of the key studies, a 15 week repeated dose study in rats provided a NOAEL of 15 mg/kg bw/day. It is readily absorbed from the gastro-intestinal tract. Considering the effects observed at 50 and 200 mg/kg bw/day: anaemia and morphological and histological changes in the thyroid, the kidneys and the pituitary, and according to CLP criteria the substanec should be classified as STOT RE Categoy 2, H373: May cause damage to organs (blood, thyroid, kidneys, pituitary) through prolonged or repeated exposure by oral route. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de1c76d5-cec8-4e1a-9c01-94ad870719a2/documents/7b66837a-b6d5-44a9-ab36-d8d3d8649a32_a1223882-993c-4e18-b1a9-7537ff2c29f8.html,,,,,, (3-ammonio-4-methoxyphenyl)(2-hydroxyethyl)ammonium sulphate,83763-48-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de1c76d5-cec8-4e1a-9c01-94ad870719a2/documents/7b66837a-b6d5-44a9-ab36-d8d3d8649a32_a1223882-993c-4e18-b1a9-7537ff2c29f8.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,300 mg/kg bw/day,,guinea pig (3-ammonio-4-methoxyphenyl)(2-hydroxyethyl)ammonium sulphate,83763-48-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de1c76d5-cec8-4e1a-9c01-94ad870719a2/documents/7b66837a-b6d5-44a9-ab36-d8d3d8649a32_a1223882-993c-4e18-b1a9-7537ff2c29f8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat (3-ammonio-4-methoxyphenyl)(2-hydroxyethyl)ammonium sulphate,83763-48-8," Based on the result of the key study (OCED 401 method equivalent, Klimish 2), the registered item 2-amino-4-hydroxyethylaminoanisole sulfate was defined as Toxic Acute Hazard Category 4 according to GHS regulation. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de1c76d5-cec8-4e1a-9c01-94ad870719a2/documents/7c8abce2-35d8-47e3-b07a-6a06f36ed835_a1223882-993c-4e18-b1a9-7537ff2c29f8.html,,,,,, (3-ammonio-4-methoxyphenyl)(2-hydroxyethyl)ammonium sulphate,83763-48-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de1c76d5-cec8-4e1a-9c01-94ad870719a2/documents/7c8abce2-35d8-47e3-b07a-6a06f36ed835_a1223882-993c-4e18-b1a9-7537ff2c29f8.html,,oral,LD50,588 mg/kg bw,adverse effect observed, 2-amino-4-nitrophenol,99-57-0," Repeated dose toxicity: via oral route; NOAEL was considered to be 250 mg/kg/day for test chemical in Fischer 344 male and female rats for 13 weeks by oral gavage. Repeated dose toxicity; via Inhalation route According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 2-amino-4-nitrophenol, which is reported as 0.000034952875 mmHg at 25°C as well as the particle size distribution indicates that the majority particle size is above 75 micro meter. Thus, exposure by inhalation is also unlikely for 2-amino-4-nitrophenol given the comparatively larger size of the particulates. Repeated dose toxicity; via Dermal route NOAEL was considered to be 1000 mg/kg/day for test chemical in New Zealand White male and female rabbit for 13 weeks by dermal route.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91546434-22e0-4466-a81f-6cbdd5fa9ddd/documents/b5bb5925-161f-402c-af79-e932e5572caf_ac467085-7844-4a27-a872-9e231d30389f.html,,,,,, 2-amino-4-nitrophenol,99-57-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91546434-22e0-4466-a81f-6cbdd5fa9ddd/documents/b5bb5925-161f-402c-af79-e932e5572caf_ac467085-7844-4a27-a872-9e231d30389f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 2-amino-4-nitrophenol,99-57-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91546434-22e0-4466-a81f-6cbdd5fa9ddd/documents/b5bb5925-161f-402c-af79-e932e5572caf_ac467085-7844-4a27-a872-9e231d30389f.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rabbit 2-amino-4-nitrophenol,99-57-0," Acute oral toxicity:  Acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the given test chemical. The LD50 value was considered to be 2400 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  Acute Inhalation toxicity dose (LC50) was considered based on different studies conducted on mice and rats for the test chemical. The LC50 value was considered to be 527 mg/L (527000 mg/m3). The study concluded that the LC50 value is >5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute Inhalation toxicity. Acute Dermal toxicity:  The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The LD50 value is 2190 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91546434-22e0-4466-a81f-6cbdd5fa9ddd/documents/2a4cc0db-58a9-485e-967e-b7decfd4591a_ac467085-7844-4a27-a872-9e231d30389f.html,,,,,, 2-amino-4-nitrophenol,99-57-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91546434-22e0-4466-a81f-6cbdd5fa9ddd/documents/2a4cc0db-58a9-485e-967e-b7decfd4591a_ac467085-7844-4a27-a872-9e231d30389f.html,,oral,LD50,"2,400 mg/kg bw",no adverse effect observed, 2-amino-4-nitrophenol,99-57-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91546434-22e0-4466-a81f-6cbdd5fa9ddd/documents/2a4cc0db-58a9-485e-967e-b7decfd4591a_ac467085-7844-4a27-a872-9e231d30389f.html,,dermal,LD50,"2,190 mg/kg bw",no adverse effect observed, 2-amino-4-nitrophenol,99-57-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91546434-22e0-4466-a81f-6cbdd5fa9ddd/documents/2a4cc0db-58a9-485e-967e-b7decfd4591a_ac467085-7844-4a27-a872-9e231d30389f.html,,inhalation,LC50,"527,000 mg/m3",no adverse effect observed, 2-amino-6-chloro-4-nitrophenol,6358-09-4," The repeated dose oral toxicity study of Chlororange (2-amino-6-chloro-4-nitrophenol) was performed by following methods similar to the OECD Guideline 408 (Repeated Dose 90 -Day Oral Toxicity in Rodents). Male and female rats were assigned to 4 groups (15 animals/sex/group;for control and 90 mg/kg dose groups an additional 10 animals/sex formed recovery groups) and were treated for 90 days as follows: Group 1: Control (0.5% Carboxymethylcellulose) Group 2: 10 mg/kg bw/day Group 3: 30 mg/kg bw/day Group 4: 90 mg/kg bw/day No animals died during the study. No adverse clinical signs, except for an orange-red discoloration of urines in the mid and high dose animals, were observed. Body weight gain rates were significantly reduced in high-dose males during the second half of the study. The reduced male body weight was nearly compensated by significantly increased weight gain rates during the recovery period. No significant differences were seen in food consumption andfood conversion ratios. Hematological investigation revealed intergroup differences in prothrombin time, leukocyte and reticulocyte count, which occurred sporadically within the limits of the normal range. Clinical chemistry values indicated several statistical significant intergroup differences. These changes, however, were not persistent, not dose-related and randomly sex-related and were therefore considered to be coincidental. No test substance-related findings were seen at terminal autopsy. Organ weight changes of the liver, lung and thymus of males and females in the high dose and recovery groups were not consistent. However, increases in kidney weight were found in males and females both of the high dose and recovery groups. The histomorphological examinations revealed no treatment related organ alterations in high-dose group animals. Based on above, treatment related adverse effects were observed at the highest tested dose level i.e.90 mg/kg bw/day (reduced body weight and increased kidney weights). In conclusion, Chlororange (2-amino-6-chloro-4-nitrophenol) when administered by oral gavage daily for 13 weeks to male and female Crl: Wi/Br strain Wistar rats at dose levels of 0, 10, 30 and 90 mg/kg bw/day, revealed a no observed adverse effect level (NOAEL) at 30 mg/kg bw/day for male and female rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bcd0b12-a2ff-4d45-a6f2-0c03f6c1f774/documents/b47ba31a-1dc7-4ba6-90f7-8d50b2066175_9d5b8f71-c3fa-447c-87cd-577c60cb53f6.html,,,,,, 2-amino-6-chloro-4-nitrophenol,6358-09-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bcd0b12-a2ff-4d45-a6f2-0c03f6c1f774/documents/b47ba31a-1dc7-4ba6-90f7-8d50b2066175_9d5b8f71-c3fa-447c-87cd-577c60cb53f6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat 2-amino-6-chloro-4-nitrophenol,6358-09-4," In the study of Chibanguza (1988) the acute oral toxicity (LD50) of Cholorange(2 -Amino-6 -chloro-4 -nitrophenol) was determined orally on male and female rats.Crl.:(WI) BR - Wistar rats. The test substance was administered as a 20% dilution in aqua deionto animals orally by stomach tube at a limit dose of 2000 mg/kg bw to ten animals (5 males and 5 females). Post treatment, animals were examined for mortality and clinical signs at about 20 minutes, 1h, 2 h, 3h, 6 h, 24h, 48 h and thereafter once daily up to Day 14. Body weights were recorded on Day 0, Day 7 and on Day 14. After 14 days of observation, all surviving animals were subjected to complete gross necropsy following their sacrifice at the end of Day 14 or spontaneous death. No mortality was observed during the study.Red-orange-stained bedding (urines red-orange-stained) was observed up to 5 days post administration.Body weights changes after each observation period showed a normal weight gain. No macroscopic findings were noted during necropsy. Based on above, the acute oral toxicity (LD50) of Cholorange was determined to be > 2000 mg/kg bw.Therefore, this test substance is not classified according to EU criteria for classification. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bcd0b12-a2ff-4d45-a6f2-0c03f6c1f774/documents/202bfaa2-cd76-481f-96a0-4f549ec946d2_9d5b8f71-c3fa-447c-87cd-577c60cb53f6.html,,,,,, 2-amino-6-chloro-4-nitrophenol,6358-09-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bcd0b12-a2ff-4d45-a6f2-0c03f6c1f774/documents/202bfaa2-cd76-481f-96a0-4f549ec946d2_9d5b8f71-c3fa-447c-87cd-577c60cb53f6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-aminobutan-1-ol,96-20-8,"The REACH dataset for 2AB (2-Aminobutan-1-ol, CAS N° 96-20-8) includes read-across studies on analogues 2AB-HCl (2-Aminobutan-1-ol hydrochloride, CAS N° 59173-62-5), AMP (2-Amino-2-methylpropanol, CAS N° 124-68-5) and AMP-HCl (2-Amino-2-methylpropanol hydrochloride, CAS N° 3207-12-3). A read-across justification document is included in IUCLID section 13 and allows to extend all knowledge and conclusions on AMP/AMP-HCl/2AB-HCl to 2AB. The read-across approach is essentially based on: 1) very close structure, 2) structural similarity with essential nutrient choline which is involved in the toxicity mode of action, 3) identical toxicological effects and target organs, and 4) very close pKa values for AMP and 2AB (alkaline substances) and neutral state for their salts AMP-HCl and 2AB-HCl.   A) ORAL ROUTE I. Selection of key studies in animals: A large number of animal studies are available on the repeated dose oral toxicity of AMP and AMP-HCl (including via reproduction and developmental toxicity studies) so the AMP toxicological database is of unprecedented quality and allows a highly robust assessment for read-across to 2AB. AMP was tested under multiple forms with variable pH (as highly alkaline AMP, pH-adjusted AMP, or AMP HCl where pH is also artificially reduced), variable purity (industrial or high-purity grade) and dosing regimen (in diet or by gavage), in multiple species (rat, mouse, rabbit, dog, monkey) and over multiple dosing periods (5 days to 1 year). Clinical data are also available and summarized in next sections. Dog studies are not included in the 2AB dataset as dog is not a recommended species and to keep the 2AB dataset at a manageable size. In addition, repeated dose oral toxicity data on 2AB-HCl are available in an OECD 422 study. All studies are outlined in Table 1 below. For repeat-dose toxicity, the liver was AMP’s and 2AB’s target organ in all animal studies which included suitable investigations. Generally, this was evidenced by increased liver enzymes and liver weight and hepatocyte vacuolation. The only other toxic effect was local toxicity caused by the alkalinity of test materials in studies with no or partial pH adjustment. There was no clear trend concerning compared sensitivity between males and females. Table 1: Overview of animal repeat-dose toxicity studies Reference Test item Species Duration (weeks) Neutralized ? Dosage form pH at LOAEL, if it hadn’t been neutralized Gives robust information about liver toxicity ? NOAEL males NOAEL females LOAEL males LOAEL females MTD males MTD females Millard 2021 AMP-HCl Rat 18 Yes 10.9-11.1 Yes 71 >=142 142 not reached not reached not reached Lankas 1981 AMP-HCl Rat 13 Yes 10.8-11.1 Partial (histopathology at top-dose only) 19 23 187 233 not reached not reached Pittz 1977/1979  AMP Rat 13 No Measured: >11 No (no histopathology) ND ND ND ND < 500 500 to <750 Pittz 1977/1979  AMP Rat 13 Yes 12.3 Partial (histopathology at top-dose only) <=750 <=750 <=1100 <=1100 not reached not reached Goldenthal 1976 AMP Rat 8 Yes ? 11.2-11.7 Yes 162 345 314 717 not reached 717 to <1355 Goldenthal 1976 AMP Mouse 8 Yes ? No LOAEL No (too low doses tested) >=501 >=685 not reached not reached not reached not reached Carney 2005 AMP-HCl Rat 5 to 8 Yes 10.6-10.7 Yes 213 <71 710 71 not reached not reached Carney 2010 2AB-HCl Rat 5 to 8 Yes 10.7 Yes 40 40 229 229 not reached not reached Murphy 2020 AMP Rabbit 3 Yes 11.7 (at lethal dose) No (no histopathology) ND ND ND ND ND 23.7 to <71.0 Carney 2005 AMP-HCl Rat 2 Yes No LOAEL No (no histopathology) ND ND ND ND not reached not reached Pittz 1977 AMP Rat 0.7 (5d) No Measured: >11 No (histopathology after 10-day recovery) ND ND ND ND 1000 to <2500 500 to <1000 Pittz 1977 AMP Monkey 0.7 (5d) No Measured: >11 No (histopathology after 10-day recovery) ND ND ND ND ND < 500 NOAEL/LOAEL/MTD values in mg AMP or 2AB (base)/kg/day. Blue: excludes use to derive a long-term DNEL. Bold: key studies. ND: not determined due to missing investigations. Red: excess pH, MTD would have been exceeded if AMP or 2AB hadn’t been neutralized. Following selection criteria were used to select the two key studies to derive a long-term DNEL: studies shorter than 4 weeks are excluded; studies which failed to identify a LOAEL (too low dose-levels) are excluded; studies which did not investigate liver histopathology at all dose-levels are excluded, as liver is the target organ and histopathology the best way to determine adversity of effects; where several studies remain, the study of longest duration is selected. As a consequence, the 3 following key studies are selected: for AMP-HCl, the key study is the OECD 443 study (Millard 2021, 18-weeks); for 2AB-HCl, it is the OECD 422 study (Carney 2010, 5 to 8 weeks); the OECD 421 study on AMP-HCl (Carney 2005, 5 to 8 weeks) also needs to be considered to compare both test items for the purpose of read-across. All 3 studies involved neutralization of AMP or 2AB’s pH and are thus largely over-conservative. This is further discussed below. II. Species sensitivity ranking by oral route: No sensitivity ranking can be proposed for 2AB as only rat data are available. Assessment of all repeat-dose toxicity data on AMP/AMP-HCl allowed to conclude the following species sensitivity ranking (for details, see AMP REACH registration): general toxicity: rabbit > monkey/dog > rat > mouse (insufficient data to compare dog/monkey and to rank humans) liver toxicity: dog > rat > mouse (insufficient data to rank rabbit, monkey and humans) III. Description of key studies in rats: a) AMP-HCl 18-week study (Millard, 2021): In an OECD 443 study, groups of 19 to 30 CD rats/sex/dose were fed diets containing AMP-HCl over two generations. Toxicologically relevant effects were limited to liver toxicity in male rats of F0 and F1A generations (doses converted into AMP): At 142 mg AMP/kg bw/day, liver weights were 12% increased in F0 only, and minimal to moderate (adverse) hepatocellular vacuolation was seen in 24/30 F0 rats and 8/20 F1A rats; At 71 mg AMP/kg bw/day, non-adverse hepatocellular vacuolation was seen in 11/25 F0 rats (minimal to mild) and 7/22 F1A rats (minimal); At 35 mg AMP/kg bw/day, non-adverse minimal hepatocellular vacuolation was seen in 4/25 F0 rats and 1/22 F1A rats. The NOAEL for parental/general toxicity was 71 and 142 mg AMP/kg bw/day in males and females, resp. The absence of irreversible liver lesions means effects do not warrant STOT RE classification. At the LOAEL (males: 142 mg AMP/kg bw/day), diet contained 0.224-0.341 % w/w AMP, allowing to estimate that diet pH would range 10.9-11.1 (see Fernandes 2023 under IUCLID §4.20). Turner et al, 2011 (see IUCLID § 4.20) indicate that oral dosage above pH 9 may result in tissue necrosis and vascular thrombosis. Thus, if AMP had been tested as is instead of its neutralized form AMP-HCl, the study’s LOAEL could not have been reached due to dose-limiting, pH-mediated toxicity and no other toxic effects would have been noted. Since OECD guidelines referenced by REACH do NOT require any neutralization or pH adjustment, this study represents artificial dose maximization in excess of REACH principles, removing AMP's critical toxic effect which is pH-dependent non-specific toxicity. This bias introduced by neutralization, also affecting the two other key studies below, is discussed in more details below (part C)). b) AMP-HCl 5-to-8 week study (Carney 2005): In an OECD 421 study, groups of 12 CD rats/sex/dose were fed diets containing AMP-HCl. Duration of treatment was: F0 males: 5 weeks, F0 females: <8 weeks, F1: <4 weeks (indirect via gestation and 4-day lactation). The following repeat-dose toxicity effects were noted: At 710 mg AMP/kg bw/day, liver weights were increased in males only. Hepatocellular changes were noted in all animals: very slight diffuse cytoplasmic microvacuolization in periportal zone and multifocal vacuolization consistent with fatty change (grade: up to ""readily observed""). Kidney weights were increased in males, non toxicologically relevant in absence of histopathological changes.  At 213 and 71 mg AMP/kg bw/day, females showed similar hepatocellular changes as at 710 mg AMP/kg bw/day.  As fatty liver was ""readily observed"" at the high- (both sexes), mid- and low-dose levels (females only), it is proposed to consider this level of fatty change as adverse and to set NOAELs for parental toxicity at 213 mg AMP/kg bw/day in males and < 71 mg AMP/kg bw/day in females. The analogue 2AB-HCl showed similar effects in an OECD 422 study (see below). Compared to the OECD 443 study on AMP-HCl (see above) in same strain of rats and same dietary administration method, OECD 421/422 study designs are much less robust as they include half less animals (12 vs. 19-30/sex/dose-level) and exposure period is much shorter (F0 males: 5 weeks, F0 females: <8 weeks, F1: < 4 weeks indirect via gestation/4-day lactation; vs. in OECD 443: F0 males/females: 18 weeks, F1: 6 weeks indirect via gestation/lactation + 13-14 weeks via diet). At the LOAEL (females: 71 mg AMP/kg bw/day), diet contained 0.087-0.116 % w/w AMP, allowing to estimate that diet pH would range 10.6-10.7 (see Fernandes 2023 under IUCLID §4.20). Thus, if AMP had been tested as is instead of AMP-HCl, the LOAEL could not have been reached due to dose-limiting, pH-mediated toxicity. This study represents artificial dose maximization in excess of REACH principles, removing AMP's critical toxic effect which is pH-dependent non-specific toxicity. c) 2AB-HCl 5-to-8 week study (Carney 2010): In an OECD 422 study, groups of 12 CD rats/sex/dose were fed diets containing 2AB-HCl. Duration of treatment was: F0 males: <5 weeks, F0 females: <8 weeks, F1: <4 weeks (indirect via gestation and 4-day lactation). The following repeat-dose toxicity effects were noted: At 229 mg 2AB/kg bw/day: parental local effects : dermal inflammation in 1/12 male and 8/12 females, possibly induced by feed contact as 2AB is corrosive to skin. parental systemic effects: both sexes showed lower body weight (-6% to -8% on last day) and food consumption (-8% to -11%) during pre-mating. Males had slight increases in alanine aminotransferase and aspartate aminotransferase activities. Males had higher relative liver weight (female organ weights were not assessed). Most animals in both sexes showed very slight hepatocellular hypertrophy and 4/12 males showed slight hepatocellular vacuolization (fatty change). Males had increased urine pH due to elimination of alkaline 2AB (non-adverse effect). At 40 mg 2AB/kg bw/day: parental systemic effects: both sexes had higher liver weights and females had higher adrenal weights (non-adverse in absence of microscopic findings). Males had increased urine pH (non-adverse). At 7.8 mg 2AB/kg/day: parental systemic effects: males had increased urine pH (non-adverse). Segregation of adverse/non-adverse effects allows to set NOAEL/LOAEL values for local and systemic parental toxicity (both sexes) as 40/229 mg 2AB/kg bw/day, resp. The analogue AMP-HCl showed similar effects in an OECD 421 study (see above). Compared to the OECD 443 study, OECD 421/422 study designs are much less robust (half less animals, much shorter exposure). At the NOAEL (40 mg 2AB/kg bw/day), diet contained 0.0486-0.0503 % w/w 2AB, allowing to estimate that diet pH would be 10.7 (see Fernandes 2023 under IUCLID §4.20). Thus, if 2AB had been tested as is instead of 2AB-HCl, the LOAEL could not have been reached due to dose-limiting, pH-mediated toxicity. This study represents artificial dose maximization in excess of REACH principles, removing AMP's critical toxic effect which is pH-dependent non-specific toxicity. IV. Read-across of AMP-HCl animal data to 2AB: A read-across justification document is included in IUCLID section 13 and allows to extend all knowledge and conclusions on AMP/AMP-HCl/2AB-HCl to 2AB. To determine whether NOAEL values from AMP-HCl’s OECD 443 study (most robust study) can be directly extrapolated to 2AB or need correction, it is necessary to check the relative potency of both substances in terms of liver histopathological lesions. The below table allows a comparison of AMP-HCl’s and 2AB-HCl’s dose-responses for hepatocyte vacuolation, with dose-levels ranked in ascending order. Table 2: Overview of hepatocyte vacuolation dose-response in rat key studies on AMP-HCl and 2AB-HCl 2AB-HCl, OECD 422 (Carney 2010) AMP-HCl, OECD 421 (Carney 2005) AMP-HCl, OECD 443 (Millard 2021)   M F   M F   M F Dose-level 0 0 Dose-level 0 0 Dose-level 0 0 very slight 7/12 6/12 grade 1 2/12 3/12 minimal 0/25 0/25 slight 1/12 2/12 grade 2 0/12 0/12 mild 0/25 0/25   grade 3 0/12 0/12 moderate 0/25 0/25 Dose-level 7.8 7.8 not tested not tested very slight 9/12 12/12 slight 1/12 0/12 Dose-level 40 40 not tested Dose-level 35 35 very slight 8/12 8/12 minimal 4/25 ND slight 0/12 2/12 mild 0/25 ND       moderate 0/25 ND not tested Dose-level 71 71 Dose-level 71 71 grade 1 2/12 5/12 minimal 10/25 ND grade 2 0/12 3/12 mild 1/25 ND grade 3 0/12 4/12 moderate 0/25 ND not tested not tested Dose-level 142 142 minimal 10/30 0/30 mild 7/30 0/30 moderate 7/30 0/30 Dose-level 229 229 Dose-level 213 213 not tested very slight 8/12 9/12 grade 1 1/12 6/12 slight 4/12 1/12 grade 2 0/12 1/12       grade 3 0/12 4/12 not tested Dose-level 710 710 not tested grade 1 3/12 5/12 grade 2 6/12 5/12 grade 3 1/12 1/12 Bold: NOAEL   red: adverse effects, LOAEL.   NOAEL/LOAEL values in mg AMP or 2AB (base)/kg/day.      Grades: 1: infrequently observed, 2: occasionally observed, 3: readily observed. ND: not investigated. This comparison evidences that: There is no consistent sensitivity difference between sexes. Therefore, it is proposed to focus on the most sensitive sex for each study (females for Carney 2005, males for Carney 2010 and Millard 2021). The two screening studies (Carney 2005 and 2010) show that 2AB-HCl induces less important hepatocyte vacuolation than AMP-HCl (max grades at 213-229 mg base/kg/day were “slight” vs. “readily observed"", resp.). In AMP-HCl studies (Carney 2005, Millard 2021), longer exposure at same dose-level of 71 mg AMP/kg/day halved the incidence and reduced the importance of hepatocyte vacuolation. Thus, lesions do not involve accumulation of any material and are reversible. As 2AB induced less pronounced liver effects than AMP, there is neither a need to correct AMP-HCl's OECD 443 NOAEL value of 71 mg AMP/kg/day to cover 2AB, nor a need for an extra safety factor in systemic DNEL derivation to reflect read-across. V. Human oral key studies on pamabrom (see Exposure related observations in humans, IUCLID § 7.10.3): Pamabrom is an Over The Counter (OTC) diuretic agent which is an AMP salt of 8-bromotheophylline, CAS No. 606-04-2. It is an equimolar mixture of 74.4% w/w 8-Bromotheophylline (CAS No. 10381-75-6) and 25.6% w/w AMP. Clinical data on this test material can be used for AMP safety assessment based on the AMP/Pamabrom bioequivalence study (see Basic Toxicokinetics /IUCLID §7.1.1) which indicated that Pamabrom’s AMP, and AMP as is, were equivalent in terms of AUC0-t, AUC0-inf and AUC0-168h. Pamabrom doses can be converted into equivalent AMP doses based on the AMP content of 25.6% w/w in this drug and assuming a patient weight of 70 kg when not indicated. a) Clinical trials: Six clinical studies are available on pamabrom. NOAELs are expressed in AMP based on pamabrom posology and AMP content. In all cases the below-listed NOAELs were the maximum tested dose: 1) Trial in severe cardiac failure patients (Doherty et al, 1953): Only 2/18 patients reported adverse effects potentially related to pamabrom upon longer treatment: 1/18 case of maculopapular rash (4th week of treatment) and 1/18 case of diarrhea (day 120 of treatment). A third patient stopped treatment after 2 weeks due to therapeutic success. The NOAEL was therefore >= 2.2 mg AMP/kg bw/day x 2 to 17 weeks depending on patient. 2) Trial in women with premenstrual tension - Preliminary study (McGavack et al, 1956): No adverse effect in n=9 women. The NOAEL was >= 2.9 mg AMP/kg bw/day x 4 weeks. 3) Trial in women with premenstrual tension - Main study (McGavack et al, 1956): No adverse effect in n=43 women. The NOAEL was >= 1.5 mg AMP/kg bw/day x 2 weeks (mean: variable   treatment regime). 4) Trial in women with primary dysmenorrhea (Ortiz et al, 2016): Minor effects in 3/189 patients (somnolence, dizziness and increased thirst, 1 case each). The NOAEL was >= 0.32 mg AMP/kg bw/day x 3 days. 5) Trial in pregnant women (Patterson, 1958): No adverse effects in n=38 pregnant women with edema classified as mild pre-eclampsia. The NOAEL was >= 5.9 mg AMP/kg bw/day x 1 week (if considering only the second treatment cycle), and >= 2.9 mg AMP/kg bw/day x 2 weeks (if considering both treatment cycles in patients treated twice). 6) Trial in pregnant women (James et al, 1957): No adverse effects in n=180 pregnant women with edema treated for unknown duration (Klimisch 4 study). The max. NOAEL was >= 2.2 mg AMP/kg bw/day, and in most patients it was >=1.6 mg AMP/kg bw/day. Considering all clinical trials, the most robust human NOAEL for repeat-dose toxicity comes from study 2) with monitoring of hematology and blood biochemistry. The NOAEL was >= 2.9 mg AMP/kg bw/day x 4 weeks. b) 70 years of safe clinical use - Pharmacovigilance argument: In the US, pamabrom is used since early 1950’s so it has a track-record of >70 years of safe use in an ill population. Based on the National Library of Medicines database, at least 20 US OTC drugs currently contain pamabrom (full list provided in study summary). Their claims include back/leg/joint pain and edema (1 drug) and premenstrual and menstrual pain/discomfort/edema (19 drugs). Based on contents and posology for each drug, AMP has a human NOAEL of >=0.73 mg AMP/kg/day for up to 10-day treatment cycles, repeated over periods. c) Overall human oral NOAEL for repeat-dose toxicity: No serious adverse effect was ever reported during 70 years of clinical trials and medication with pamabrom based on 5 publications (6 trials) and posology of 20 OTC drugs. The most robust human NOAEL for repeat-dose toxicity comes from study 2) (preliminary study by McGavack et al, 1956) where the NOAEL was >= 2.9 mg AMP/kg bw/day x 4 weeks. All other studies and OTC drug posology confirm AMP NOAEL values in the mg/kg bw/day range, always the highest tested dose whatever the treatment duration (3 days to 17 weeks + one trial where treatment duration was not indicated). The fact that the NOAEL in human is lower than in rats does not mean that humans are more sensitive, as no higher dose-levels have been tested in humans. Therefore the human NOAEL is underestimated and cannot be used to set the long-term systemic DNEL value.   B) OTHER ROUTES I. Dermal route (Carney 2006): This OECD 414 study cannot be used to derive repeat-dose toxicity DNELs because: AMP was adjusted to pH 9.5 (limiting the potential to express local effects); The study did not include liver histopathology (leaving systemic effects unexplored). II. Inhalation route (Sullivan 2017): Nose-only exposure of rats to AMP aerosol (10% AMP solution in water) for 6 hours/day for 5 days at 700 to 2000 mg AMP/m3 resulted in: Significant local irritation/corrosion on skin (scabs, crusts, epidermal hyperplasia, mixed cell infiltrates, necrosis and ulceration); Significant local irritation/corrosion in nasal cavities (atrophy of goblet cells and olfactory epithelium, epithelium hyperplasia, mixed cell infiltrates, squamous metaplasia of respiratory epithelium, ulceration of turbinates); Minimal systemic toxicity in liver (increased aspartate aminotransferase, decreased albumin, higher liver weight, hepatocyte vacuolation). Based on Fernandes, 2023 (see IUCLID § 4.20), pH of a 10% AMP solution would be 12.3, confirming that the observed skin and respiratory tract lesions represent corrosive effects (local toxicity). The study conclusion did not distinguish local and systemic NOAEC/LOAEC values. Based on corrosion to skin/respiratory tract, the local LOAEC was <=700 mg/m3 in both sexes. Based on minimal liver vacuolation, the systemic NOAEC and LOAEC were 700 and 1400 mg/m3 in both sexes, resp. Minimal liver vacuolation being a reversible effect, STOT RE classification is not required. This study shows that the most sensitive general toxic effect upon inhalation of high airborne AMP concentrations is not liver toxicity but pH-related corrosion of respiratory tract and skin.   C) NON-RELEVANCE OF ADVERSE EFFECTS TO HUMANS I. Influence of pH adjustment on relevance of toxicology studies for hazard classification (see pH and pKa, IUCLID § 4.20/4.21): Bibliography on maximum tolerated pH, together with pH/concentration curves for AMP (Fernandes, 2023), allow to conclude that repeated administration of non-neutralized AMP solutions above: 0005% w/w for oral route (reaching pH 9, maximum tolerated pH by oral route according to Turner, 2011), or 8% w/w for topical application (reaching pH 11.5, maximum tolerated pH for skin according to Shu-Hua 2020, REACH regulation 2006, ECHA 2017), would lead to animal death or severe dose-limiting suffering. In almost all AMP/2AB in vivo toxicology studies (see IUCLID § 7.5.1, 7.5.3, 7.8), neutralization of AMP/2AB (pH adjustment or testing as hydrochloride salts) allowed to test much higher concentrations and (in some studies) observe toxic effects. Since OECD guidelines referenced by REACH do NOT require any neutralization or pH adjustment, such studies represent artificial dose maximization in excess of REACH principles, removing AMP/2AB's critical toxic effect which is pH-dependent non-specific toxicity. This is confirmed experimentally by the 4 in vivo repeat-dose studies (see IUCLID §7.5.1 and 7.5.2) where AMP was tested without pH adjustment: A 13-week oral rat study (Pittz 1977/79) was done in duplicate at 500 to 1700 mg AMP/kg bw/day with or without neutralization to pH 6.5-7.3 using HCl. Non-neutralized AMP triggered mortality from 500 mg/kg bw/day due to pH >11 in dosage forms, while neutralized AMP did not cause death up to 1700 mg/kg bw/day. This proves that neutralizing AMP artificially increases its maximum tolerated dose (MTD) by a factor of at least 3.5. In a 5-day study on rats inhaling non-neutralized AMP aerosols (Sullivan 2017), local corrosion to skin and respiratory tract occurred at much lower airborne concentrations (LOAEC: 700 mg/m3) than liver toxicity (non-adverse minimal hepatocyte vacuolation up to 2000 mg/m3). pH of the 10% aerosol was calculated as 12.3 using the pH curves. Thus, protecting against local effects upon inhalation will protect against systemic effects. In 5-day oral studies in rats and monkeys (Pittz 1977) where non-neutralized AMP reached pH >11, mortality occurred in both species. The maximum tolerated dose (MTD) in mg AMP/kg bw/day were: well below 500 in female monkeys; 500 in female rats; 1000 in male rats. No NOAEL could be set in either species due to a 10-day recovery before necropsy and liver examinations. GHS/CLP classification is about hazard and not about risk. It aims at identifying high-dose effects of the pure substance tested in animals according to OECD guidelines, not effects of a neutralized salt which is another chemical. AMP/2AB being highly alkaline substances, this limits dose-levels and the pattern is dominated by local toxic effects. Identifying potential risks at low-dose as can exist in actual exposure conditions (where pH is balanced), is not the aim of GHS/CLP classification, but the aim of chemical risk assessment. Therefore, toxicity observed only thanks to adjustment of pH shall be ignored for classification but shall be considered for risk assessment (DNEL derivation). II. Ingestion (only route with adverse liver toxicity) is a negligible exposure route for REACH identified uses: Adverse liver effects were only observed after dietary ingestion of AMP-HCl or 2AB-HCl (see IUCLID §7.5.1), and not in dermal and inhalation studies (see IUCLID § 7.5.2/7.5.3). The liver is the first organ exposed to AMP after gastro-intestinal absorption (first-pass effect), so the observed adverse effects on the liver can only occur upon direct ingestion. In humans, direct ingestion only happens via the OTC drug pamabrom and such US pharma uses are out of scope of REACH/GHS/CLP. AMP and 2AB are not approved food additives in EU and are not used to treat drinking water so REACH identified uses do not involve direct ingestion of AMP or 2AB. AMP and 2AB are extremely water soluble, readily biodegradable and non-bioaccumulative so no significant oral exposure to AMP or 2AB via environmental emissions is expected from REACH identified uses. For all these reasons, toxicology data acquired by oral route are an extreme, barely realistic worst-case of actual systemic toxicity potential by exposure routes related to REACH uses. Indeed, by skin contact and inhalation, systemic exposure potential to AMP and 2AB is very limited due to: risk management measures protecting against local corrosive effects of AMP, 2AB and their industrial formulations (see CSR); negligible volatility (vapour pressure: 45 Pa for AMP at 20°C, 58.1 Pa for 2AB at 25°C); few identified uses with a potential to generate aerosols (see IUCLID § 3.5 Use information); low concentration in end products (use as pH modifier, see CSR); only 7-17% dermal absorption of AMP through human skin (see IUCLID § 7.1.2 Dermal absorption); absence of liver first-pass effect by these routes: the liver is exposed to much smaller concentrations of AMP/2AB than by ingestion of the same total exposure dose. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c70a6f2-2819-44d4-a322-6a4a08068652/documents/IUC5-699ddcc3-85d7-4075-9ffc-367d8fe069c8_824e3f7c-abd6-4b45-a2c8-c6513b3af5ec.html,,,,,, 2-aminobutan-1-ol,96-20-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c70a6f2-2819-44d4-a322-6a4a08068652/documents/IUC5-699ddcc3-85d7-4075-9ffc-367d8fe069c8_824e3f7c-abd6-4b45-a2c8-c6513b3af5ec.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,700 mg/m3,,rat 2-aminobutan-1-ol,96-20-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c70a6f2-2819-44d4-a322-6a4a08068652/documents/IUC5-699ddcc3-85d7-4075-9ffc-367d8fe069c8_824e3f7c-abd6-4b45-a2c8-c6513b3af5ec.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,71 mg/kg bw/day,,rat 2-aminobutan-1-ol,96-20-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c70a6f2-2819-44d4-a322-6a4a08068652/documents/IUC5-699ddcc3-85d7-4075-9ffc-367d8fe069c8_824e3f7c-abd6-4b45-a2c8-c6513b3af5ec.html,Repeated dose toxicity – local effects,inhalation,LOAEC,700 mg/m3,adverse effect observed,rat 2-aminobutan-1-ol,96-20-8,"Acute oral LD50 of 2AB was > 1800 mg/kg bw (1/5 deaths) in male rats and ranged 800-1800 mg/kg bw (0/5-5/5 deaths, resp.) in females. ATE value is concluded as 1300 mg/kg bw, the average between female LD0 and LD100 values (800 and 1800 mg/kg bw, resp.). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c70a6f2-2819-44d4-a322-6a4a08068652/documents/IUC5-062ebdcd-6246-4c8f-95aa-bde5ae8a39c0_824e3f7c-abd6-4b45-a2c8-c6513b3af5ec.html,,,,,, 2-aminobutan-1-ol,96-20-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c70a6f2-2819-44d4-a322-6a4a08068652/documents/IUC5-062ebdcd-6246-4c8f-95aa-bde5ae8a39c0_824e3f7c-abd6-4b45-a2c8-c6513b3af5ec.html,,oral,LD50,"1,300 mg/kg bw",adverse effect observed, 2-benzylheptanol,92368-90-6, The acute oral LD50 was established to be greater than 5000 mg/kg bw. The acute dermal LD50 was > 5000 mg/kg bw in rats.   ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54a60e70-47e3-4aa2-a330-3a0417717681/documents/IUC5-82019298-c62f-436b-86bc-e56508eb8612_e320c458-1500-4b2d-8e23-105d9a3b159e.html,,,,,, 2-benzylheptanol,92368-90-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54a60e70-47e3-4aa2-a330-3a0417717681/documents/IUC5-82019298-c62f-436b-86bc-e56508eb8612_e320c458-1500-4b2d-8e23-105d9a3b159e.html,,oral,discriminating dose,"5,000 mg/kg bw",adverse effect observed, 2-benzylheptanol,92368-90-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54a60e70-47e3-4aa2-a330-3a0417717681/documents/IUC5-82019298-c62f-436b-86bc-e56508eb8612_e320c458-1500-4b2d-8e23-105d9a3b159e.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Bronopol,52-51-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): The database for repeated dose dermal toxicity is complete and is considered to meet the relevant data requirements of REACH. No concentration of Bronopol with clear effects of systemic toxicity were noted in a well-documented study in rabbits up to and including the high-dose level of 5 mg/kg bw/day. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): The database for repeated dose dermal toxicity is complete and is considered to meet the relevant data requirements of REACH. No concentration of Bronopol with clear toxic effects was tested in this well-documented study on rabbits. NOAEL: 2 mg/kg bw/day; LOAEL: 5 mg/kg bw/day (referring to skin findings). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The database for repeated dose oral toxicity (systemic effects) is complete and is considered to meet the relevant data requirements of REACH. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19800cb9-abcd-4c9a-9539-01fc146a5cc4/documents/IUC5-185d74be-4571-4881-a0e8-f82cd1f0acd0_9b0dc721-a290-4fc6-bf1d-53085c4a805b.html,,,,,, Bronopol,52-51-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19800cb9-abcd-4c9a-9539-01fc146a5cc4/documents/IUC5-185d74be-4571-4881-a0e8-f82cd1f0acd0_9b0dc721-a290-4fc6-bf1d-53085c4a805b.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,5 mg/kg bw/day,,rabbit Bronopol,52-51-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19800cb9-abcd-4c9a-9539-01fc146a5cc4/documents/IUC5-185d74be-4571-4881-a0e8-f82cd1f0acd0_9b0dc721-a290-4fc6-bf1d-53085c4a805b.html,Chronic toxicity – systemic effects,oral,NOAEL,7 mg/kg bw/day,,rat Bronopol,52-51-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19800cb9-abcd-4c9a-9539-01fc146a5cc4/documents/IUC5-185d74be-4571-4881-a0e8-f82cd1f0acd0_9b0dc721-a290-4fc6-bf1d-53085c4a805b.html,Repeated dose toxicity – local effects,dermal,,2 ,adverse effect observed,rabbit Bronopol,52-51-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The key study was selected. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): No exact LC50 could be determined. Therefore, the classification is based on a weight of evidence approach considering the LC50 (4h) > 580 mg/m3 determined in the study by Hazleton Laboratories Europe Ltd (1986) and the LC50 (4h) > 120 - < 1140 mg/m3 determined in the study by Dow (2003). An aerosol was tested in both studies. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The key study was selected. As LD50 value >2000 mg/kg was determined. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19800cb9-abcd-4c9a-9539-01fc146a5cc4/documents/IUC5-faba712a-20e0-424c-bbc5-1c2677a39deb_9b0dc721-a290-4fc6-bf1d-53085c4a805b.html,,,,,, Bronopol,52-51-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19800cb9-abcd-4c9a-9539-01fc146a5cc4/documents/IUC5-faba712a-20e0-424c-bbc5-1c2677a39deb_9b0dc721-a290-4fc6-bf1d-53085c4a805b.html,,oral,LD50,193 mg/kg bw,adverse effect observed, Bronopol,52-51-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19800cb9-abcd-4c9a-9539-01fc146a5cc4/documents/IUC5-faba712a-20e0-424c-bbc5-1c2677a39deb_9b0dc721-a290-4fc6-bf1d-53085c4a805b.html,,dermal,discriminating dose,"2,000 mg/kg bw",adverse effect observed, Bronopol,52-51-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19800cb9-abcd-4c9a-9539-01fc146a5cc4/documents/IUC5-faba712a-20e0-424c-bbc5-1c2677a39deb_9b0dc721-a290-4fc6-bf1d-53085c4a805b.html,,inhalation,discriminating conc.,588 mg/m3,adverse effect observed, "2-chlorobenzene-1,4-diammonium sulphate",6219-71-2," Repeated dose toxicity: Oral Combined repeated dose & carcinogenicity study was performed to determine the toxic nature of 2-Chloro-p-phenylenediamine SO4. The study was performed using 6 week old male F344 rats in a 28 days study. The test chemical was mixed with 1% CMC and used at dose level of 0 or 100 mg/Kg/day.Rats were humanly sacrificed with CO2-O2 (4:1) gas inhalation at 3, 14 or 28 days after administration. The livers were immediately excised and weighed. Tissues were fixed in 10% neutral-buffered formalin, and subsequently sectioned and stained with hematoxylin and eosin.No histological abnormalities were noted due to test chemical treatment. The No Observed Adverse Effect Level (NOAEL) for 2-Chloro-p-phenylenediamine SO4 is considered to be 100 mg/kg/day. Repeated dose toxicity: Inhalation 2-chlorobenzene-1,4-diammonium sulphate has very low vapor pressure (2.12E-012 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated inhalation toxicity was considered for waiver Repeated dose toxicity: Dermal The acute dermal toxicity value for 2-chlorobenzene-1,4-diammonium sulphate (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not irritating and not sensitizing to the skin. Based on these considerations, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a96e6f4e-8164-4b20-a12e-537ba88c336b/documents/26807f9b-b0be-4d1f-8284-3238050cbd2d_555e9362-6d29-4c83-87e1-cad3ec533b58.html,,,,,, "2-chlorobenzene-1,4-diammonium sulphate",6219-71-2,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a96e6f4e-8164-4b20-a12e-537ba88c336b/documents/26807f9b-b0be-4d1f-8284-3238050cbd2d_555e9362-6d29-4c83-87e1-cad3ec533b58.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2-chlorobenzene-1,4-diammonium sulphate",6219-71-2," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target substance 2-chlorobenzene-1,4-diammonium sulphate (6219-71-2) was estimated to be 3976.64 mg/kg bw,and for differentstudies available on the structurally similar read across substance 6-aminonaphthalene-2-sulphonic acid (93-00-5) was considered to be 5000 mg/kg bw and for 1,3-Phenylenediamine-4-sulfonic acid (88-63-1) was considered to be 3480 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-chlorobenzene-1,4-diammonium sulphate (6219-71-2) cannot be classified for acute oral toxicity. Acute Inhalation Toxicity:  2-chlorobenzene-1,4-diammonium sulphate has very low vapor pressure (2.12E-012 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for acute inhalation toxicity was considered for waiver. Acute Dermal Toxicity: In Acute dermal toxicity, LD50 value was predicted based on OECD QSAR toolbox for target substance 2-chlorobenzene-1,4-diammonium sulphate (6219-71-2) was estimated to be 20718.78 mg/kg bw andfor differentstudies available on structurally similar read across substance 6-aminonaphthalene-2-sulphonic acid (93-00-5)was considered to be >2000 mg/kg bw and for functionally similar read across substance 4,4'-Diaminodiphenyl sulfone (80-08-0) was considered to be >4000 mg/kg bw.All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-chlorobenzene-1,4-diammonium sulphate (6219-71-2) cannot be classified for acute dermal toxicity. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a96e6f4e-8164-4b20-a12e-537ba88c336b/documents/3e5d9b37-f83f-4a19-9dd9-3b3b5fef3663_555e9362-6d29-4c83-87e1-cad3ec533b58.html,,,,,, "2-chlorobenzene-1,4-diammonium sulphate",6219-71-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a96e6f4e-8164-4b20-a12e-537ba88c336b/documents/3e5d9b37-f83f-4a19-9dd9-3b3b5fef3663_555e9362-6d29-4c83-87e1-cad3ec533b58.html,,oral,LD50,"3,976.64 mg/kg bw",no adverse effect observed, "2-chlorobenzene-1,4-diammonium sulphate",6219-71-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a96e6f4e-8164-4b20-a12e-537ba88c336b/documents/3e5d9b37-f83f-4a19-9dd9-3b3b5fef3663_555e9362-6d29-4c83-87e1-cad3ec533b58.html,,dermal,LD50,"20,718.78 mg/kg bw",no adverse effect observed, 2-ethyl-3-methylpyrazine,15707-23-0, In an acute oral toxicity study the oral LD50 value for the test substance was determined to be 600 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bbe7eb6-56d8-4958-8bb7-503749fdee47/documents/a7f17d4c-5f12-4514-b7d2-a78d57d7d1ca_2b0fedd8-0577-46bc-bf19-d114a6e46df3.html,,,,,, 2-ethyl-3-methylpyrazine,15707-23-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bbe7eb6-56d8-4958-8bb7-503749fdee47/documents/a7f17d4c-5f12-4514-b7d2-a78d57d7d1ca_2b0fedd8-0577-46bc-bf19-d114a6e46df3.html,,oral,LD50,600 mg/kg bw,adverse effect observed, 2-ethylbutyric acid,88-09-5," 2-Ethylbutyric acid was shown to have a No Observed Adverse Effect Level (NOAEL) of 300 mg/kg bw/day in rats as part of a 14-day repeated dose toxicity (oral) experiment. A combined repeated dose and reproductive / developmental toxicity experiment was performed for 2-ethylbutyric acid over a 42-day period, in which there was a reported decrease in white blood cells at 50 mg/kg bw/day and in platelet count at 250 mg/kg bw/day in male rats. Following necropsy, kidney weight was reported to be significantly higher at 250 mg/kg bw/day in male and female rats. The NOAEL was subsequently considered to be 10 mg/kg bw/day in males and 50 mg/kg bw/day in females. The results of this experiment have been selected for the purpose of the endpoint conclusion given that they are more conservative and they have been obtained in a key study (Klimisch score = 2). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cdcfdbb-9b5c-4298-b031-3776b6298d78/documents/4376c881-30a2-4fab-898b-5901377cfdb5_2cd08534-0e2c-477d-864d-218417425659.html,,,,,, 2-ethylbutyric acid,88-09-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cdcfdbb-9b5c-4298-b031-3776b6298d78/documents/4376c881-30a2-4fab-898b-5901377cfdb5_2cd08534-0e2c-477d-864d-218417425659.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat 2-ethylbutyric acid,88-09-5," An LD50 (lethal dose, 50 %) of >2000 mg/kg and 2200 mg/kg was obtained for 2-ethylbutyric acid in two studies for acute toxicity in rats via the oral route. As the former result is more conservative and is based on a reliable study report (Klimisch score = 2), the endpoint conclusion for acute toxicity (oral) is concluded to be >2000 mg/kg. This value is outside of the CLP Regulation (EC) No 1272/2008 criteria and, therefore, the registered substance does not require classification as an acute oral toxin. An LD50 of 0.52 ml/kg (478 mg/kg) was determined in a range-finding acute toxicity (dermal) experiment involving rabbits. The endpoint conclusion for acute dermal toxicity has been selected as LD50 = 478 mg/kg, which is indicative of the registered substance requiring a classification for Acute Toxicity (Dermal) (Category 3) (CLP Regulation (EC) No 1272/2008). 2-Ethylbutyric acid can be regarded as an acute toxin (Category 3) via the dermal route. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cdcfdbb-9b5c-4298-b031-3776b6298d78/documents/5455bed3-17dc-4fd0-bce2-abb3548230a6_2cd08534-0e2c-477d-864d-218417425659.html,,,,,, 2-ethylbutyric acid,88-09-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cdcfdbb-9b5c-4298-b031-3776b6298d78/documents/5455bed3-17dc-4fd0-bce2-abb3548230a6_2cd08534-0e2c-477d-864d-218417425659.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-ethylbutyric acid,88-09-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cdcfdbb-9b5c-4298-b031-3776b6298d78/documents/5455bed3-17dc-4fd0-bce2-abb3548230a6_2cd08534-0e2c-477d-864d-218417425659.html,,dermal,LD50,478 mg/kg bw,adverse effect observed, 2-ethylhexan-1-ol,104-76-7,"The oral chronic NOAEL was 200 mg/kg bw in male and female mice in a 2-year carcinogenicity study, based on organ weight changes and mortality at higher doses. The oral subchronic NOAEL was 250 mg/kg bw in male and female Fischer F344 rats and B6C3F1 mice; based on local irritation of the forestomach and increased relative organ weights (stomach, liver in rats and mice; additionally brain, kidneys, testes in rats).No treatment-related effects were noted in a OECD Guideline 413 study (Subchronic Inhalation Toxicity: 90-Day). The NOAEC was 120 ppm, i.e. 638.4 mg/m³ the highest concentration tested. No reliable study with repeated dermal application is available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d43acac3-4454-467c-9a0e-691ee6b94b37/documents/755b2312-e699-4438-a0b7-2a25507c1d4a_0fdb2f54-c7d7-4ccf-8b15-1139d4d34547.html,,,,,, 2-ethylhexan-1-ol,104-76-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d43acac3-4454-467c-9a0e-691ee6b94b37/documents/755b2312-e699-4438-a0b7-2a25507c1d4a_0fdb2f54-c7d7-4ccf-8b15-1139d4d34547.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,mouse 2-ethylhexan-1-ol,104-76-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d43acac3-4454-467c-9a0e-691ee6b94b37/documents/755b2312-e699-4438-a0b7-2a25507c1d4a_0fdb2f54-c7d7-4ccf-8b15-1139d4d34547.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,638.4 mg/m3,,rat 2-ethylhexan-1-ol,104-76-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d43acac3-4454-467c-9a0e-691ee6b94b37/documents/755b2312-e699-4438-a0b7-2a25507c1d4a_0fdb2f54-c7d7-4ccf-8b15-1139d4d34547.html,Chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,mouse 2-ethylhexan-1-ol,104-76-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d43acac3-4454-467c-9a0e-691ee6b94b37/documents/755b2312-e699-4438-a0b7-2a25507c1d4a_0fdb2f54-c7d7-4ccf-8b15-1139d4d34547.html,Repeated dose toxicity – local effects,inhalation,NOAEC,53.2 mg/m3,adverse effect observed, 2-ethylhexan-1-ol,104-76-7,"Oral LD50 (rat) = 2047 mg/kg bwDermal LD0 (rat) >3000 mg/kg bwInhalation LC50 (rat) - vapour: no mortality at 0.89 mg/L (4h) or when exposed to saturation concentration (1, 2, 4, and 8 h) - mixed vapour and aerosol: between 1 and 4 mg/L ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d43acac3-4454-467c-9a0e-691ee6b94b37/documents/a4def130-96d0-4fc1-860a-a9d6de50be87_0fdb2f54-c7d7-4ccf-8b15-1139d4d34547.html,,,,,, 2-ethylhexan-1-ol,104-76-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d43acac3-4454-467c-9a0e-691ee6b94b37/documents/a4def130-96d0-4fc1-860a-a9d6de50be87_0fdb2f54-c7d7-4ccf-8b15-1139d4d34547.html,,oral,LD50,"2,047 mg/kg bw",adverse effect observed, 2-ethylhexan-1-ol,104-76-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d43acac3-4454-467c-9a0e-691ee6b94b37/documents/a4def130-96d0-4fc1-860a-a9d6de50be87_0fdb2f54-c7d7-4ccf-8b15-1139d4d34547.html,,dermal,LD0,"> 3,000 mg/kg bw",no adverse effect observed, 2-ethylhexan-1-ol,104-76-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d43acac3-4454-467c-9a0e-691ee6b94b37/documents/a4def130-96d0-4fc1-860a-a9d6de50be87_0fdb2f54-c7d7-4ccf-8b15-1139d4d34547.html,,inhalation,LC50,> 1 mg/L,adverse effect observed, "3,3'-[methylenebis(oxymethylene)]bisheptane",22174-70-5,Reliable study OECD guideline followed and GLP compliant ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bd4bd91-7ae2-4904-8324-65022fde0f27/documents/IUC5-36273994-f473-41bd-b710-281adc9eeeef_031ae80e-2913-4fff-9481-cd924109f582.html,,,,,, "3,3'-[methylenebis(oxymethylene)]bisheptane",22174-70-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bd4bd91-7ae2-4904-8324-65022fde0f27/documents/IUC5-36273994-f473-41bd-b710-281adc9eeeef_031ae80e-2913-4fff-9481-cd924109f582.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,3'-[methylenebis(oxymethylene)]bisheptane",22174-70-5,The test was performed according to OECD TG 423 and GLP (Klimisch code 1) The test was performed according to OECD TG 402 and GLP (Klimisch code 1) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bd4bd91-7ae2-4904-8324-65022fde0f27/documents/IUC5-847ecad1-fbd9-454a-8617-8e2dbafb9121_031ae80e-2913-4fff-9481-cd924109f582.html,,,,,, "3,3'-[methylenebis(oxymethylene)]bisheptane",22174-70-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bd4bd91-7ae2-4904-8324-65022fde0f27/documents/IUC5-847ecad1-fbd9-454a-8617-8e2dbafb9121_031ae80e-2913-4fff-9481-cd924109f582.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,3'-[methylenebis(oxymethylene)]bisheptane",22174-70-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bd4bd91-7ae2-4904-8324-65022fde0f27/documents/IUC5-847ecad1-fbd9-454a-8617-8e2dbafb9121_031ae80e-2913-4fff-9481-cd924109f582.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-(1-ethylpentyl)-1,3-dioxolane",4359-47-1,Acute oral toxicity: OECD TG 401: 7100 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e9c8b65-0f3f-4467-80a9-08f67aa6018a/documents/67fb7bed-a1a3-4339-8466-dda119572b4f_6849037c-136f-4516-97ee-575e21331e05.html,,,,,, 2-heptylcyclopentanone,137-03-1,Fleuramone tested in an OECD TG 422 the NOAEL is >= 800 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ad2de83-8a0c-4644-b30a-9e332e5a886d/documents/IUC5-57c21075-558f-4c09-887b-0d414ba6d477_12253544-43f6-4b65-96df-b4316e30e88b.html,,,,,, 2-heptylcyclopentanone,137-03-1, Acute oral toxicity (OECD TG 401): >5000 mg/kg bw. Acute dermal toxicity (OECD TG 402): =5000 mg/kg bw. Acute inhalation: no adverse effects predicted ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ad2de83-8a0c-4644-b30a-9e332e5a886d/documents/585a375c-2d8e-436e-93b7-c58fc82826d3_12253544-43f6-4b65-96df-b4316e30e88b.html,,,,,, 2-hydroxyethyl acrylate,818-61-1," 2 -hydroxyethyl acrylate (HEA) itself is comprehensively tested in respect to subacute (rat inhalation), subchronic (rat oral, dog oral) and chronic toxicity (rat inhalation). The data are supported by tests performed with the structural analogue 2 hydroxypropyl acrylate (HPA) which was tested in subacute studies in rat, mouse, dog and rabbit by inhalation exposure and in subchronic studies in rats after oral administration. Inhalation In the 2 years inhalation study with male/female Sprague-Dawley rats (DowChemCo, 1979) the lowest observed adverse effect concentration (LOAEC), based on severe local irritation effects was 5 ppm (equivalent to approx. 0.024 mg/L). No toxicity was observed in rats exposed to 0.5 ppm HEA (corresponding to 0.0024 mg/L), thus NOAEC in this study was determined to be 0.0024 mg/L. Gross and histopathologic examination of rats exposed to 5.0 ppm HEA revealed a characteristic yellow staining of the haircoat, as well as an increased incidence, increased severity and earlier onset of the lesions associated with chronic murine pneumonia. These exposure-related effects were not observed in rats exposed to 0.5 ppm HEA. Oral In the subchronic oral feed studies in rat and dogs no systemic toxicity were described up to the highest dose tested (rat: males 196 mg/kg bw/day; females 305 mg/kg bw/day) (dog: males 125 mg/kg bw/day; females 131 mg/kg bw/day). In a study according to OECD TG 422, the oral administration of HEA by gavage to male and female Wistar rats resulted in signs of parental toxicity at the mid- and high-dose of 40 and 120 mg/kg bw/d, such as a combination of clinical signs and gastrointestinal pathology, being the consequence of the irritating properties of the test item. The NOAEL for general systemic toxicity was 40 mg/kg bw/day for male and female Wistar rats based on the reduced food consuption (lactation phase) and the significant increased liver weights and the NOAEL for local effects (gastrointestinal pathology) was 12 mg/kg bw/day.The NOAEL for reproductive performance and fertility was set to 120 mg/kg bw/day for male and female Wistar rats. The NOAEL for developmental toxicity was 120 mg/kg bw/day. The structural analog hydroxypropyl acrylate (HPA) was also tested in an OECD 422 combined repeated dose toxicity study with the reproductive/developmental screening test in Wistar rats, the NOAEL (no observed adverse effect level) for general, systemic toxicity of Hydroxypropylacrylate was 150 mg/kg bw/d for male and female rats. Based on pathological findings characteristic of irritation in forestomach and duodenum in F0 parental rats of both sexes at 150 and 50 mg/kg as well as corresponding temporary reductions of food consumption in F0 females at 150 mg/kg bw/d a NOAEL of 15 mg/kg bw/d was determined for local effects in the gastrointestinal tract. The NOAEL for fertility and reproductive performance was 150 mg/kg bw/d for the F0 parental rats. The NOAEL for developmental toxicity in the F1 progeny was 150 mg/kg bw/d. In a study according OECD TG 408 performed with the structurally analogue substance HPA the NOAEL for systemic toxicity was 100 mg/kg bw/day. This study is used in a read across approach for HEA. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76033fe9-84ee-4450-97e5-519c18a7d997/documents/IUC5-d85f2165-549b-44e9-a216-4616e9f9a100_39887906-907f-42a8-9097-dd9de1e10ef0.html,,,,,, 2-hydroxyethyl acrylate,818-61-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76033fe9-84ee-4450-97e5-519c18a7d997/documents/IUC5-d85f2165-549b-44e9-a216-4616e9f9a100_39887906-907f-42a8-9097-dd9de1e10ef0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 2-hydroxyethyl acrylate,818-61-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76033fe9-84ee-4450-97e5-519c18a7d997/documents/IUC5-d85f2165-549b-44e9-a216-4616e9f9a100_39887906-907f-42a8-9097-dd9de1e10ef0.html,Chronic toxicity – systemic effects,inhalation,NOAEC,24 mg/m3,,rat 2-hydroxyethyl acrylate,818-61-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76033fe9-84ee-4450-97e5-519c18a7d997/documents/IUC5-d85f2165-549b-44e9-a216-4616e9f9a100_39887906-907f-42a8-9097-dd9de1e10ef0.html,Repeated dose toxicity – local effects,inhalation,LOAEC,24 mg/m3,adverse effect observed,rat 2-hydroxyethyl acrylate,818-61-1," Acute oral toxicity (OECD TG 401), LD50 = 540 mg/kg bw Acute dermal toxicity (OECD TG 402), LD50 > 1000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76033fe9-84ee-4450-97e5-519c18a7d997/documents/IUC5-0b71748c-e58d-4020-93e9-184917de1be9_39887906-907f-42a8-9097-dd9de1e10ef0.html,,,,,, 2-hydroxyethyl acrylate,818-61-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76033fe9-84ee-4450-97e5-519c18a7d997/documents/IUC5-0b71748c-e58d-4020-93e9-184917de1be9_39887906-907f-42a8-9097-dd9de1e10ef0.html,,oral,LD50,540 mg/kg bw,adverse effect observed, 2-hydroxyethyl acrylate,818-61-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76033fe9-84ee-4450-97e5-519c18a7d997/documents/IUC5-0b71748c-e58d-4020-93e9-184917de1be9_39887906-907f-42a8-9097-dd9de1e10ef0.html,,dermal,LD50,"1,000 mg/kg bw",no adverse effect observed, "Acrylic acid, monoester with propane-1,2-diol",25584-83-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): guideline study ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f17e660f-98c8-44b7-b97f-1543d713722a/documents/IUC5-5e8ab7b9-ac20-46d7-887a-f76592a2e7c3_f4c4e0bf-3bb2-448c-bce3-59394ea6a766.html,,,,,, "Acrylic acid, monoester with propane-1,2-diol",25584-83-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f17e660f-98c8-44b7-b97f-1543d713722a/documents/IUC5-5e8ab7b9-ac20-46d7-887a-f76592a2e7c3_f4c4e0bf-3bb2-448c-bce3-59394ea6a766.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Acrylic acid, monoester with propane-1,2-diol",25584-83-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f17e660f-98c8-44b7-b97f-1543d713722a/documents/IUC5-5e8ab7b9-ac20-46d7-887a-f76592a2e7c3_f4c4e0bf-3bb2-448c-bce3-59394ea6a766.html,Repeated dose toxicity – local effects,inhalation,NOAEC,2.4 mg/m3,adverse effect observed,rat "Acrylic acid, monoester with propane-1,2-diol",25584-83-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f17e660f-98c8-44b7-b97f-1543d713722a/documents/IUC5-d9f03daf-c187-4559-83fe-7d3649b6da02_f4c4e0bf-3bb2-448c-bce3-59394ea6a766.html,,oral,LD50,820 mg/kg bw,adverse effect observed, "Acrylic acid, monoester with propane-1,2-diol",25584-83-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f17e660f-98c8-44b7-b97f-1543d713722a/documents/IUC5-d9f03daf-c187-4559-83fe-7d3649b6da02_f4c4e0bf-3bb2-448c-bce3-59394ea6a766.html,,dermal,discriminating dose,"1,000 mg/kg bw",adverse effect observed, 3-methyl-2-butenyl salicylate,68555-58-8," In a GLP compliant and OECD guideline study on oral acute toxicity, the LD50 value was determined to be 2717 mg/kg bw after 14 days. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/158aa8ca-d4f9-4373-b5ea-53a0364f7c4c/documents/c9f828dd-81a8-40fd-a7a3-69db724743c8_97f4778d-c4d1-42de-8165-88f27d915fe7.html,,,,,, 3-methyl-2-butenyl salicylate,68555-58-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/158aa8ca-d4f9-4373-b5ea-53a0364f7c4c/documents/c9f828dd-81a8-40fd-a7a3-69db724743c8_97f4778d-c4d1-42de-8165-88f27d915fe7.html,,oral,LD50,"2,717 mg/kg bw",adverse effect observed, 2-methoxy-4-(methoxymethyl)phenol,5533-03-9,Acute oral toxicity: OECD TG 401: between 300 mg/kg and 2000 mg/kg. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdd86039-c9bf-49c1-8a8d-fd82081d5ebf/documents/f89f7bee-90cc-4f56-bd88-55a528023e3a_7a1767b0-0e15-4496-b760-952477e6ece8.html,,,,,, "2-(methoxymethyl)benzene-1,4-diamine",337906-36-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The NOAEL of the base form of MBB was calculated from the sulfate form NOAEL (90 mg/kgbw/d). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/279ae78b-dcdd-4932-9be0-180bed937b21/documents/c59bdc6e-b88f-4e73-8492-96fc15633ce4_7e14a8e2-447a-4e1e-b34c-fcab2a860557.html,,,,,, "2-(methoxymethyl)benzene-1,4-diamine",337906-36-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/279ae78b-dcdd-4932-9be0-180bed937b21/documents/c59bdc6e-b88f-4e73-8492-96fc15633ce4_7e14a8e2-447a-4e1e-b34c-fcab2a860557.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,55 mg/kg bw/day,,rat "2-(methoxymethyl)benzene-1,4-diamine",337906-36-2," The acute oral toxicity of MBB or MBB SULFATE 1:1 was determined based on the maximum tolerated dose (MTD) after oral application in in vivo genotoxicity studies in rats carried out with the sulfate salt. The determination of the MTD (with respect to the number of animals used and dose selection) was in line with the OECD guideline 423 for the determination of acute oral toxicity. The approach to determine the acute oral toxicity by using MTD data from in vivo genotoxicity studies is accepted by the German and EU regulatory agencies  and is based on the current state-of-the-art science. The calculated oral LD50 values (LD50, calc, oral) for the sulfate salt and free base of 2- METHOXY-METHYL-P-PHENYLENEDIAMINE were determined to be 150 mg/kg bw and 91.5 mg/kg bw, respectively. The LD50, calc, oral for the sulfate salt (150 mg/kg bw) was used for the route extrapolation calculations, since the in vivo toxicity and kinetics assays used in the calculations were also carried out with the sulfate salt. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/279ae78b-dcdd-4932-9be0-180bed937b21/documents/c172d92d-94fa-40e3-a7a2-aa17e271eb0d_7e14a8e2-447a-4e1e-b34c-fcab2a860557.html,,,,,, "2-(methoxymethyl)benzene-1,4-diamine",337906-36-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/279ae78b-dcdd-4932-9be0-180bed937b21/documents/c172d92d-94fa-40e3-a7a2-aa17e271eb0d_7e14a8e2-447a-4e1e-b34c-fcab2a860557.html,,oral,LD50,91.5 mg/kg bw,, "2-(methoxymethyl)benzene-1,4-diamine",337906-36-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/279ae78b-dcdd-4932-9be0-180bed937b21/documents/c172d92d-94fa-40e3-a7a2-aa17e271eb0d_7e14a8e2-447a-4e1e-b34c-fcab2a860557.html,,dermal,LD50,366 mg/kg bw,, "2-(methoxymethyl)benzene-1,4-diamine",337906-36-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/279ae78b-dcdd-4932-9be0-180bed937b21/documents/c172d92d-94fa-40e3-a7a2-aa17e271eb0d_7e14a8e2-447a-4e1e-b34c-fcab2a860557.html,,inhalation,LC50,"1,080 mg/m3",, "(R,S)-5-cyclohexyl-2-methyl-pentan-1-ol",1141487-54-8,"Results from a GLP conform combined 28-day repeated dose oral toxicity/reproduction/developmental toxicity screening study (OECD 422) in rats are available indicating no systemic effects of toxicity of the test item up to the highest does tested of 1000 mg/kg bw/d. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Acceptable (RL=1) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcac9f4b-1fd6-4306-afae-8d450e5feba3/documents/IUC5-65592a09-d71e-4a23-87ee-71fe37b4ab9d_a2af63a5-fdd4-41bd-96ea-a7afd0c0fd44.html,,,,,, "(R,S)-5-cyclohexyl-2-methyl-pentan-1-ol",1141487-54-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcac9f4b-1fd6-4306-afae-8d450e5feba3/documents/IUC5-65592a09-d71e-4a23-87ee-71fe37b4ab9d_a2af63a5-fdd4-41bd-96ea-a7afd0c0fd44.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "(R,S)-5-cyclohexyl-2-methyl-pentan-1-ol",1141487-54-8,"Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 420, GLP compliant, female rats) Acute inhalation toxicity: data waiving Acute dermal toxicity: LD50 > 2000 mg/kg bw (OECD 402, GLP compliant, male and female rats) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcac9f4b-1fd6-4306-afae-8d450e5feba3/documents/IUC5-98fd99a8-31ee-419a-9250-41936284a35e_a2af63a5-fdd4-41bd-96ea-a7afd0c0fd44.html,,,,,, "(R,S)-5-cyclohexyl-2-methyl-pentan-1-ol",1141487-54-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcac9f4b-1fd6-4306-afae-8d450e5feba3/documents/IUC5-98fd99a8-31ee-419a-9250-41936284a35e_a2af63a5-fdd4-41bd-96ea-a7afd0c0fd44.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "(R,S)-5-cyclohexyl-2-methyl-pentan-1-ol",1141487-54-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcac9f4b-1fd6-4306-afae-8d450e5feba3/documents/IUC5-98fd99a8-31ee-419a-9250-41936284a35e_a2af63a5-fdd4-41bd-96ea-a7afd0c0fd44.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Reaction mass of 2-methyl-3-{[(2R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl]oxy}propan-1-ol and 2-methyl-3-{[(2S)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl]oxy}propan-1-ol",128119-70-0,"OECD 407: NOAEL was determined to be 150 mg/kg bw/day, based on increased liver weight increases of 33 and 66% in male and female rats, respectively, treated at 1000 mg/kg bw/day. OECD 421 (male): NOAEL was determined ​to be 124 mg/kg bw, based on increased liver weight increase of 16% in male rats treated at 252-283 mg/kg bw/day. OECD 421 (female): NOAEL was determined ​to be 144 mg/kg bw, based on lower body weight (6-13%), body weight gain (35-77%) and food consumption (±24%) in female rats treated at 264-395 mg/kg bw/day.  The overall repeated dose toxicity NOAEL is set to the lowest value of 124 mg/kg bw.  ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7d46cef-98c8-4926-83be-02f07ca17d93/documents/IUC5-95a895da-2b82-4b56-b773-36d004fead02_ba551842-2291-4db0-9e22-27a41dbdc760.html,,,,,, "Reaction mass of 2-methyl-3-{[(2R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl]oxy}propan-1-ol and 2-methyl-3-{[(2S)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl]oxy}propan-1-ol",128119-70-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7d46cef-98c8-4926-83be-02f07ca17d93/documents/IUC5-95a895da-2b82-4b56-b773-36d004fead02_ba551842-2291-4db0-9e22-27a41dbdc760.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,124 mg/kg bw/day,,rat "Reaction mass of 2-methyl-3-{[(2R)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl]oxy}propan-1-ol and 2-methyl-3-{[(2S)-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl]oxy}propan-1-ol",128119-70-0,"- Oral LD50: > 2000 mg/kg bw (OECD TG 401)- Inhalation LC50 > 5200 mg/m3 (route-to-route extrapolation from acute oral toxicity study)- Dermal LD50: > 2000 mg/kg (OECD TG 402) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): One acute oral toxicity study is available, which is performed according to OECD guidelines and under GLP conditions. This study is adequate for covering this endpoint. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7d46cef-98c8-4926-83be-02f07ca17d93/documents/IUC5-be1cf54a-091e-41c4-88a7-b4063a0ded31_ba551842-2291-4db0-9e22-27a41dbdc760.html,,,,,, "2-methyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-2-buten-1-ol",28219-60-5,Repeated dose toxicity: Oral The No Observed Adverse Effect Level (NOAEL) for the given test compound was considered to be 500 mg/Kg bw/day.   Repeated dose toxicity: Inhalation A short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment.   Repeated dose toxicity: Dermal A short-term toxicity study does not need to be conducted because exposure of humans via dermal in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/300c5007-f825-4269-9638-43d6292ba91c/documents/2adbdbbe-0b67-4295-9fce-8ce8364ffd3f_0ff7b349-af27-4a4b-901b-a4da6d79c857.html,,,,,, "2-methyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-2-buten-1-ol",28219-60-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/300c5007-f825-4269-9638-43d6292ba91c/documents/2adbdbbe-0b67-4295-9fce-8ce8364ffd3f_0ff7b349-af27-4a4b-901b-a4da6d79c857.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-methyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-2-buten-1-ol",28219-60-5,"Data available for the structurally similar read across substances of the target chemical have been reviewed to determine the acute Oral, Dermal and Inhalational toxicity of the test chemical.The studies are as mentioned below: Acute oral toxicity:  The acute oral LD50 value was considered to be 3800 mg/kg bw, with 95% C.L. of 3060 – 4710 mg/kg bw, when male and female rats were treated with the test chemical (CAS 115-71-9) alpha-santalol via oral gavage route. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.   Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to low vapour pressure of the test chemical, which is reported to be 0.0317 Pa (0.000237 mmHg). Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rabbits for the given test chemical. The LD50 value is >5000 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the test chemical (CAS 115-71-9) alpha-santalol cannot be classified for acute dermal toxicity.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/300c5007-f825-4269-9638-43d6292ba91c/documents/94276668-a944-4c55-bd27-b3dc81172920_0ff7b349-af27-4a4b-901b-a4da6d79c857.html,,,,,, "2-methyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-2-buten-1-ol",28219-60-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/300c5007-f825-4269-9638-43d6292ba91c/documents/94276668-a944-4c55-bd27-b3dc81172920_0ff7b349-af27-4a4b-901b-a4da6d79c857.html,,oral,LD50,"3,800 mg/kg bw",no adverse effect observed, "2-methyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-2-buten-1-ol",28219-60-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/300c5007-f825-4269-9638-43d6292ba91c/documents/94276668-a944-4c55-bd27-b3dc81172920_0ff7b349-af27-4a4b-901b-a4da6d79c857.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, 5-[(2-hydroxyethyl)amino]-o-cresol,55302-96-0," Repeated dose toxicity: Oral (gavage): NOAEL-90 days in the male and female rat = 220 mg/kg bw/day based on clinical signs, body weight and weight gain and urinalysis (OECD Guideline 408, GLP, Klimisch 1). Dermal: no study available. Inhalation: no study available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78687ef2-8671-4c93-a013-6feaabfc163f/documents/85c20e61-c1bc-4851-9c19-4ceb8ad9e949_f8843792-dd29-4045-ae94-b6882d4acb60.html,,,,,, 5-[(2-hydroxyethyl)amino]-o-cresol,55302-96-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78687ef2-8671-4c93-a013-6feaabfc163f/documents/85c20e61-c1bc-4851-9c19-4ceb8ad9e949_f8843792-dd29-4045-ae94-b6882d4acb60.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,220 mg/kg bw/day,,rat 5-[(2-hydroxyethyl)amino]-o-cresol,55302-96-0," Oral (gavage): LD0: > 2,000 mg/kg for female rat (limit test; OECD Guideline 420, GLP, Klimisch 1) Dermal: LD50: > 2,000 mg/kg for male and female rat (limit test; OECD Guideline 402, GLP, Klimisch 1) Inhalation: no study available ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78687ef2-8671-4c93-a013-6feaabfc163f/documents/db816947-0835-4573-a1d6-41fe42f5445d_f8843792-dd29-4045-ae94-b6882d4acb60.html,,,,,, 2-methylbutan-1-ol,137-32-6,Repeated dose toxicity:The oral NOAEL was found to be at least 1000 mg/kg bw/day for all category members. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2e62c17-8b09-4b68-933f-fb72de438169/documents/e1e388b3-cff9-479b-88d9-bae4ebd26c23_6a7c2001-7f1c-4ee5-9d93-2f89f7994ea1.html,,,,,, 2-methylbutan-1-ol,137-32-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2e62c17-8b09-4b68-933f-fb72de438169/documents/e1e388b3-cff9-479b-88d9-bae4ebd26c23_6a7c2001-7f1c-4ee5-9d93-2f89f7994ea1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-methylbutan-1-ol,137-32-6,"oral:All the LD50 values of the test substance and category members were found to be greater than 2000 mg/kg bw.inhalation:No mortalities occured when 2-methylbutan-1-ol or the read-across substances were applied as vapour. In a study conducted on a read-across substance (CAS 94624-12-1), which was applied as an aerosol, the LC50 in mice was found to be < 14 mg/L, but greater than 14mg/L for rats and guinea pigs.dermal:All the dermal LD50 value were found to be greater than 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2e62c17-8b09-4b68-933f-fb72de438169/documents/9c05c0a4-6f70-4775-a166-b7de21b4eacc_6a7c2001-7f1c-4ee5-9d93-2f89f7994ea1.html,,,,,, 2-methylbutan-1-ol,137-32-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2e62c17-8b09-4b68-933f-fb72de438169/documents/9c05c0a4-6f70-4775-a166-b7de21b4eacc_6a7c2001-7f1c-4ee5-9d93-2f89f7994ea1.html,,oral,LD50,"4,172 mg/kg bw",adverse effect observed, 2-methylbutan-1-ol,137-32-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2e62c17-8b09-4b68-933f-fb72de438169/documents/9c05c0a4-6f70-4775-a166-b7de21b4eacc_6a7c2001-7f1c-4ee5-9d93-2f89f7994ea1.html,,dermal,LD50,"2,889 mg/kg bw",adverse effect observed, 2-methylbutan-1-ol,137-32-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2e62c17-8b09-4b68-933f-fb72de438169/documents/9c05c0a4-6f70-4775-a166-b7de21b4eacc_6a7c2001-7f1c-4ee5-9d93-2f89f7994ea1.html,,inhalation,discriminating conc.,"12,500 mg/m3",no adverse effect observed, 2-methylbutyraldehyde,96-17-3,"The oral LD50 of 2-methylbutyraldehyde was determined to be 6880 mg/kg bw in male rats (Carpenter, 1974).The inhalation LC50 of 2-methylbutyraldehyde was determined to be 50.5 mg/L in rats (Carpenter, 1974).The dermal LD50 of 2-methylbutyraldehyde was determined to be 5400 mg/kg in male rabbits (Carpenter, 1974). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67a1aa80-5fa1-4c74-a7e0-4d57fe2e56ae/documents/IUC5-fe5c03e2-91b0-4cfa-a762-d48276a16b3c_e4b126ed-431b-4270-a54d-16e15c5156ad.html,,,,,, 2-methylbutyraldehyde,96-17-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67a1aa80-5fa1-4c74-a7e0-4d57fe2e56ae/documents/IUC5-fe5c03e2-91b0-4cfa-a762-d48276a16b3c_e4b126ed-431b-4270-a54d-16e15c5156ad.html,,oral,LD50,"6,880 mg/kg bw",, 2-methylbutyraldehyde,96-17-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67a1aa80-5fa1-4c74-a7e0-4d57fe2e56ae/documents/IUC5-fe5c03e2-91b0-4cfa-a762-d48276a16b3c_e4b126ed-431b-4270-a54d-16e15c5156ad.html,,dermal,LD50,"5,400 mg/kg bw",, 2-methylbutyraldehyde,96-17-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67a1aa80-5fa1-4c74-a7e0-4d57fe2e56ae/documents/IUC5-fe5c03e2-91b0-4cfa-a762-d48276a16b3c_e4b126ed-431b-4270-a54d-16e15c5156ad.html,,inhalation,LC50,"50,500 mg/m3",, Isobutyraldehyde,78-84-2,"No systemic effects were observed in rats and mice after inhalation exposure for 90 days at all concentrations, which did not cause lethality due to lung lesions as a result of a local irritant reaction. The NOAEC in both species was 5.9mg/L (2000ppm).The mouse was more susceptible to local irritation. The NOAEC in the mouse was 1.5mg/L (500ppm) vs 2.9mg/L (1000ppm) in the rat. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69ef5694-c21f-44e1-8022-4603272603bb/documents/IUC5-16a3b869-298f-4daf-969d-c54465791116_c6334697-ffb3-464a-ae77-e3a74cdf93d2.html,,,,,, Isobutyraldehyde,78-84-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69ef5694-c21f-44e1-8022-4603272603bb/documents/IUC5-16a3b869-298f-4daf-969d-c54465791116_c6334697-ffb3-464a-ae77-e3a74cdf93d2.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"5,900 mg/m3",,other:Mouse and rat Isobutyraldehyde,78-84-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69ef5694-c21f-44e1-8022-4603272603bb/documents/IUC5-16a3b869-298f-4daf-969d-c54465791116_c6334697-ffb3-464a-ae77-e3a74cdf93d2.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,500 mg/m3",adverse effect observed,mouse Isobutyraldehyde,78-84-2,The LD50 for acute oral toxicity was determined to be 3730 mg/kg bw.The LC50 for acute inhalation toxicity was determined to be above 23.6 mg/L air after a 4 hour exposure.The LD50 for acute dermal toxicity was determined to be 5583 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69ef5694-c21f-44e1-8022-4603272603bb/documents/IUC5-062e57d8-ed82-40de-ada1-ba4fc8c89b78_c6334697-ffb3-464a-ae77-e3a74cdf93d2.html,,,,,, Isobutyraldehyde,78-84-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69ef5694-c21f-44e1-8022-4603272603bb/documents/IUC5-062e57d8-ed82-40de-ada1-ba4fc8c89b78_c6334697-ffb3-464a-ae77-e3a74cdf93d2.html,,oral,LD50,"3,730 mg/kg bw",adverse effect observed, Isobutyraldehyde,78-84-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69ef5694-c21f-44e1-8022-4603272603bb/documents/IUC5-062e57d8-ed82-40de-ada1-ba4fc8c89b78_c6334697-ffb3-464a-ae77-e3a74cdf93d2.html,,dermal,LD50,"5,583 mg/kg bw",adverse effect observed, Isobutyraldehyde,78-84-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69ef5694-c21f-44e1-8022-4603272603bb/documents/IUC5-062e57d8-ed82-40de-ada1-ba4fc8c89b78_c6334697-ffb3-464a-ae77-e3a74cdf93d2.html,,inhalation,discriminating conc.,"23,600 mg/m3",adverse effect observed, 2-methylpropan-1-ol,78-83-1,"oral   90 d, rat, drinking water: NOAEL >= ca. 1450 mg/kg bw/ day (= 16000 ppm; no effects observed; OECD 408, GLP; BG Chemie 1990)   90 d, rat, gavage: NOAEL >= 1000 mg/kg bw/ day; NOEL =316 mg/kg bw/day due to transient clinical signs and transient body weight gain reduction (GLP; US EPA 1985)   dermal   4-6 times 0.3 mL for 24 h within 7 d, rabbit, occlusive: no systemic toxicity studied; local: highly irritant (TSCATS OTS 0510692, 1986; Val. 4)   inhalation   90 d, rat, 6 h/d, 5 d/wk: NOAEL systemic >= ca. 7.5 mg/L/day (2500 ppm); NOEL systemic = ca. 3.0 mg/L/day due to slight hematologic effects with questionable biological significance (GLP, neurotoxicity guideline, CMA 1996a)   2-gen study/ca. 17 wks for the parental generation, 6 h/d, 7 d/wk: NOAEL systemic >= ca. 7.5 mg/L/day (2500 ppm, no effects observed; GLP, EPA OPPTS 870.3800; ACC 2003) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f3334d6-b7be-4612-9809-cb4adfce3f97/documents/IUC5-b3ce2eac-f108-40f3-9209-aa8dfae73fb9_db2338c0-88b3-4de4-9244-e339276527cb.html,,,,,, 2-methylpropan-1-ol,78-83-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f3334d6-b7be-4612-9809-cb4adfce3f97/documents/IUC5-b3ce2eac-f108-40f3-9209-aa8dfae73fb9_db2338c0-88b3-4de4-9244-e339276527cb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,450 mg/kg bw/day",,rat 2-methylpropan-1-ol,78-83-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f3334d6-b7be-4612-9809-cb4adfce3f97/documents/IUC5-b3ce2eac-f108-40f3-9209-aa8dfae73fb9_db2338c0-88b3-4de4-9244-e339276527cb.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"7,500 mg/m3",,rat 2-methylpropan-1-ol,78-83-1,"Oral   Rat: LD50 = >2830 mg/kg bw (males)/ 3350 mg/kg bw (females; GLP, OECD 401; Union Carbide Corporation 1993)   Mouse: LD50 = 3500 mg/kg bw (Kushneva et al. 1983, Val. 4)   Rabbit: LD50 = ca. 3000 mg/kg bw (Munch 1972).   Inhalation   Rat, 6 h: LC0 >= 18.2 mg/L (GLP, neurotoxicity guideline, CMA 1994)   Rat, 4 h: LC50 = 24.6 mg/L (standardized test; Smyth et al. 1954)   Rat, 4 h: LC50 = 19.6 mg/L; irritation of the respiratory tract (Kushneva et al. 1983, Val. 4)   Mouse, 4 h: LC50 = 15.5 mg/L (Kushneva et al. 1983, Val. 4)   Rabbit, 4 h: LC50 = 26.3 mg/L (Kushneva et al. 1983, Val. 4)   Guinea pig, 4 h: LC50 = 19.9 mg/L (Kushneva et al. 1983, Val. 4)   Dermal   Rabbit: LD50 = > 2000 mg/kg bw (males); 2460 mg/kg bw (females; GLP, OECD 402; Union Carbide Corporation 1993)   Rabbit: LD 50 = 3392 mg/kg bw (males; standardized test; Smyth et al. 1954)   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f3334d6-b7be-4612-9809-cb4adfce3f97/documents/IUC5-b0cf0b35-cb1b-498a-b62f-f13a267cc061_db2338c0-88b3-4de4-9244-e339276527cb.html,,,,,, 2-methylpropan-1-ol,78-83-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f3334d6-b7be-4612-9809-cb4adfce3f97/documents/IUC5-b0cf0b35-cb1b-498a-b62f-f13a267cc061_db2338c0-88b3-4de4-9244-e339276527cb.html,,oral,LD50,"3,350 mg/kg bw",adverse effect observed, 2-methylpropan-1-ol,78-83-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f3334d6-b7be-4612-9809-cb4adfce3f97/documents/IUC5-b0cf0b35-cb1b-498a-b62f-f13a267cc061_db2338c0-88b3-4de4-9244-e339276527cb.html,,dermal,LD50,"2,460 mg/kg bw",adverse effect observed, 2-methylpropan-1-ol,78-83-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f3334d6-b7be-4612-9809-cb4adfce3f97/documents/IUC5-b0cf0b35-cb1b-498a-b62f-f13a267cc061_db2338c0-88b3-4de4-9244-e339276527cb.html,,inhalation,discriminating conc.,"18,200 mg/m3",no adverse effect observed, 2-methylresorcinol,608-25-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/992c6cd1-f821-44f6-b186-eae738d68d6e/documents/IUC5-334d0232-77a2-4354-9515-3a6537254a3a_75802f4d-e233-4856-a987-f2f3a510e0eb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 2-methylresorcinol,608-25-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/992c6cd1-f821-44f6-b186-eae738d68d6e/documents/IUC5-f971ad64-33a1-403a-8193-321c837a92d2_75802f4d-e233-4856-a987-f2f3a510e0eb.html,,oral,LD50,200 mg/kg bw,adverse effect observed, 2-naphthol,135-19-3,"The toxicity of 2-naphthol following a short-term (4 weeks) repeated oral exposure was investigated using a method similar to the OECD Testing Guideline 407. The study was GLP-compliant. Groups of five male and female SD rats were exposed to 0, 50, 150 or 450 mg/kg bw/d of test substance in CMC. In addition, two groups of five male and female SD rats received 0 or 450 mg/kg bw/d of test substance in CMC to be used as recovery groups.  The recovery period was 4 weeks. Animals were observed twice daily for mortality and general clinical signs. More in-depth clinical observations were conducted weekly. Bodyweights were recorded weekly. Food and water consumptions were calculated on a weekly or daily basis, respectively. During the last week of the treatment and recovery periods, blood and urine samples were collected to investigate haematology and clinical chemistry parameters, and to conduct urinalysis. Ophthalmological examination was conducted on all groups prior to commencement, and during week 4 of treatment and recovery periods. Animals were sacrificed at the end of the treatment or recovery period. Detailed post-mortem examinations were conducted. Absolute and relative weight of selected organs were determined. Histopathological examination of selected tissues was conducted. The results of the study indicate that daily administration of the test substance was well-tolerated by animals exposed for 4 consecutive weeks. A slight increase in both absolute and relative adrenal weight was reported in all treated groups, but no relationship with dose levels was observed. Limited findings were concluded to be treatment-related, including brown staining of the coat in female animals receiving the highest-dose of test substance, as well as transient changes in the levels of creatinine, sodium and calcium in male animals at the same dose levels. While these changes in creatinine levels could potentially be indicative of a nephrotoxic effects, no supportive findings were identified during this study. A NOAEL of 150 mg/kg bw/d can be derived from these results based on the brown staining observed in female animals, and changes in several clinical biochemistry parameters at 450 mg/kg bw/d. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33e0ed17-b162-41dc-878f-6cde696b3449/documents/48539cec-dd44-4620-8929-49ec43a714aa_7ceb832c-d42f-4829-8cc1-204b770d64bb.html,,,,,, 2-naphthol,135-19-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33e0ed17-b162-41dc-878f-6cde696b3449/documents/48539cec-dd44-4620-8929-49ec43a714aa_7ceb832c-d42f-4829-8cc1-204b770d64bb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat 2-naphthol,135-19-3,"The acute toxicity of the test substance 2-naphthol via the oral route was evaluated during a study performed according to the OECD Testing Guideline 401 (Acute Oral Toxicity).  The study was GLP compliant.   The fixed dose method was used.  The following doses were investigated and administered by gavage.   1250 mg/kg bw: concentration in sesame oil: 25%, administration volume: 5 ml/kg b.w.1600 mg/kg bw: concentration in sesame oil: 25%, administration volume: 6 and 4 ml/kg b.w.2000 mg/kg bw: concentration in sesame oil: 25%, administration volume: 8 ml/kg b.w.2500 mg/kg bw: concentration in sesame oil: 25%, administration volume: 10 ml/kg b.w.   Following exposure to the test substance, animals were observed for 14 days.  Lethality occured until day 3 after administration.  The following clinical signs were observed at the day of administration: decreased spontaneous activity, squatting position, prone/lateral position, irregular breathing, respiratory rales, narrowed palpebral fissure and bristled fur.  In higher doses (as from 1600 mg/kw/bw) dizziness, tonic-clonic seizures and decreased position reflexes were observed.  From day 1 after administration withdrawn flanks, blood clored incrusted muzzles and diarrhoea were observed.  For one make animal in the 2500 mg/kg/bw group the position- and paw pinch-reflex was eliminated.  For a female animal in the 2500 mg/kg/bw group no increase of body weight could be determined after 7 days.  At the end of the test period, this animal considerably exceeded its initial weight.  The development of body weight for the other animals was not affected.  The macroscopic examination of the died male and female animals revealed the following characteristics: blood vessels of the gastrointestinal tract considerably injected - stomach and small intestine filled with substance remains - stomach inflated - clotted blood in small intestines - urinary bladder fillded with brownish-gloomy liquid.  The animals killed at the end of the follow-up period were free of macroscopic visible changes.   Based on LD50 values of 1340 mg/kw/bw in female rats and 1300 mg/kg/bw in males rats, 2-naphthol was classified as harmful according to the CLP regulation.   The acute toxicity of the test substance 2-naphthol via the inhalation route was evaluated during a study performed according to the OECD Testing Guideline 403 (Acute Inhalation Toxicity).  The study was GLP compliant.   Groups of 5 male and female Wistar rats were exposed for 4 hours to concentrations of 0.9, 1.94, 2.50, 5.06 mg/L (air) of 2-naphthol. The substance was aerosoled at 50% in polyethylene glycol 400 / ethanol (1:1). Analysis were conducted during exposure to confirm the actual concentrations the animals were exposed to. At the end of exposure, animals were observed for 14 days. Bodyweight and clinical signs were recorded. At the end of the observation period, surviving animals were necropsied. All the animals exposed to the highest concentration of test substance in air were found dead by the end of the observation period. At 2.50 mg/L (air), 9/10 animals died as a result of the exposure. 1/10 animals exposed to 1.94 mg/L (air) of test substance for 4 hours was found dead. All the animals exposed to 0.90 mg/L (air) survived until the end of the observation period. The animals showed irregular respiration, sonorous rales, panting, gasping, sneezing, narrowed palpebral fissures, stilted, uncoordinated and ataxic gait, ataxia, trembling, decreased spontaneous activity, sunken flanks, squatting posture, prone position, straddling hind limbs, forward crawling, ruffled and bristling coat, blood-coloured encrusted noses, blood coloured nasal discharge, stupor, sedation, reduced or absent pawreflex to pinching, reduced or no placing reflex, delayed or no corneal reflex, corneal opacity and diarrhea. Body weight development was impaired during the first week. At the end of the study, all surviving animals had surpassed their initial weights. At necropsy, changes were observed in the lungs of animals. The 4h-LC50 was determined to be 2.20 mg/L (air) based on the deaths observed during the study. Since this value is between 1.0 and 5.0 mg/L (air), 2-naphthol meets the criteria for classification as Acute Tox. 4; H332 according to Regulation (EC) No.1272/2008.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33e0ed17-b162-41dc-878f-6cde696b3449/documents/a0b6f9af-f44b-4b37-980e-a12e6f18400d_7ceb832c-d42f-4829-8cc1-204b770d64bb.html,,,,,, 2-naphthol,135-19-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33e0ed17-b162-41dc-878f-6cde696b3449/documents/a0b6f9af-f44b-4b37-980e-a12e6f18400d_7ceb832c-d42f-4829-8cc1-204b770d64bb.html,,oral,LD50,"1,300 mg/kg bw",adverse effect observed, 2-naphthol,135-19-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33e0ed17-b162-41dc-878f-6cde696b3449/documents/a0b6f9af-f44b-4b37-980e-a12e6f18400d_7ceb832c-d42f-4829-8cc1-204b770d64bb.html,,inhalation,LC50,2.2 mg/m3,adverse effect observed, 2-nitro-p-phenylenediamine,5307-14-2,"The compound, 2-nitro-p-phenylenediamin, was administered orally in an oil-in-water emulsion by stomach tube to groups of ten fasted Charles River CD rats (five males and five females per group).The LD50's were calculated by the method of Weil (1952).The LD50 and its 95% confidence limits was 3080 (2130 – 4460) mg/kgbw for the test material. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2314a91c-650c-4f42-b180-921711286158/documents/IUC5-daa5962e-a0d9-41d3-9ea4-e373b9de684b_39f0591a-62b2-4160-b409-a3656e5367c0.html,,,,,, 2-nitro-p-phenylenediamine,5307-14-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2314a91c-650c-4f42-b180-921711286158/documents/IUC5-daa5962e-a0d9-41d3-9ea4-e373b9de684b_39f0591a-62b2-4160-b409-a3656e5367c0.html,,oral,LD50,"3,080 mg/kg bw",no adverse effect observed, 2-o-tolylethanol,19819-98-8,"Acute oral toxicity (read across from Etaphen, which is tested in an OECD TG 401): LD50 = 1609.3 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1191eed-db5a-406b-b2c6-e279a5fbfbfb/documents/IUC5-12beae78-d8fa-406f-91dc-02149113d93f_d26c4806-63dc-4b9b-b16a-6f28a1f52f9a.html,,,,,, 2-o-tolylethanol,19819-98-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1191eed-db5a-406b-b2c6-e279a5fbfbfb/documents/IUC5-12beae78-d8fa-406f-91dc-02149113d93f_d26c4806-63dc-4b9b-b16a-6f28a1f52f9a.html,,oral,LD50,"1,609.3 mg/kg bw",adverse effect observed, Octan-2-ol,123-96-6," The test item, was administered daily by oral gavage to male and female Sprague-Dawley rats, for 2 weeks before mating, during mating, and until sacrifice for males, or through gestation and until Day 14 p.p. for females, at dose-levels of 100, 300 and 1000 mg/kg/day.Based on the results, the NOAEL (No Observed Adverse Effect Level) was considered to be 300 mg/kg/day for systemic toxicity due to clinical signs observed at the high dose-level and 100 mg/kg/day for local toxicity due to microscopic findings noted in the forestomach of animals of the mid- and high-dose groups. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db8f1b1e-f4bf-499c-aaf0-2d46c30d9553/documents/022fb8df-a04f-4891-968e-966d2fec240a_80eb8550-6009-4e3a-ac55-f57bfb0f157f.html,,,,,, Octan-2-ol,123-96-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db8f1b1e-f4bf-499c-aaf0-2d46c30d9553/documents/022fb8df-a04f-4891-968e-966d2fec240a_80eb8550-6009-4e3a-ac55-f57bfb0f157f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Octan-2-ol,123-96-6, One acute study by oral route is available for octan-2-ol with an LD50 > 2000 mg/kg. No mortality was observed indicating that acute toxicity is of low concern. No acute studies are available by dermal route or inhalation. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db8f1b1e-f4bf-499c-aaf0-2d46c30d9553/documents/77958363-e613-409e-a15e-1a11883bad95_80eb8550-6009-4e3a-ac55-f57bfb0f157f.html,,,,,, Octan-2-ol,123-96-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db8f1b1e-f4bf-499c-aaf0-2d46c30d9553/documents/77958363-e613-409e-a15e-1a11883bad95_80eb8550-6009-4e3a-ac55-f57bfb0f157f.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-sec-butylcyclohexan-1-one,14765-30-1, Combined 28-Day Toxicity Study with the Reproduction/Developmental Toxicity Screening Test of FRESKOMENTHE by Dietary Administration in Rats test dated on 2017 and performed according to the OECD Guideline No. 422 ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c1fec23-2a1d-47cd-bb08-9256d8b7369d/documents/9c88b965-cacb-4702-bb66-69d17afaca82_6b7e050e-91e5-4112-9ad8-96070c30d18f.html,,,,,, 2-sec-butylcyclohexan-1-one,14765-30-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c1fec23-2a1d-47cd-bb08-9256d8b7369d/documents/9c88b965-cacb-4702-bb66-69d17afaca82_6b7e050e-91e5-4112-9ad8-96070c30d18f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,151 mg/kg bw/day,,rat 2-sec-butylcyclohexan-1-one,14765-30-1," The Freskomenthe, Acute Oral Toxicity In Rats test owned by RIFM dated on 1978 has determined a Freskomenthe LD50 (rat) = 2400mg/Kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c1fec23-2a1d-47cd-bb08-9256d8b7369d/documents/8c058f18-0582-4598-891a-31c113b3021f_6b7e050e-91e5-4112-9ad8-96070c30d18f.html,,,,,, 2-sec-butylcyclohexan-1-one,14765-30-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c1fec23-2a1d-47cd-bb08-9256d8b7369d/documents/8c058f18-0582-4598-891a-31c113b3021f_6b7e050e-91e5-4112-9ad8-96070c30d18f.html,,oral,LD50,"2,400 mg/kg bw",adverse effect observed, 2-tert-butyl-p-cresol,2409-55-4,"A valid proprietary acute oral toxicity is available. According this study the LD50 = 3150 mg/kg is established for male and female rats. A supporting study also conducted with rats revealed a LD50 =2500 mg/kg bw. Rats seems to be less sensitive compared with mice and guinea pigs. In an older and less valid study for dermal toxicity a LD50 = 2200 mg/kg bw (24 h, rabbit) was found. The substance seems to have low systemic toxicity, but may cause fatalities through exposure of relatively large areas of the skin. This may be due to secondary effects from the severe chemical burn rather than from systemic effects of the compound (LD50 = 2200 mg/kg bw is also quoted in the MAK statement for 2-tert-butyl-p-cresol).  ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f3fd483-d5cf-467b-a1ee-9708db3edd07/documents/IUC5-d5e62e1e-6b1b-4630-b034-935b130ff587_d7c4458c-9a82-4b96-abd5-6226440e5dbc.html,,,,,, 2-tert-butyl-p-cresol,2409-55-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f3fd483-d5cf-467b-a1ee-9708db3edd07/documents/IUC5-d5e62e1e-6b1b-4630-b034-935b130ff587_d7c4458c-9a82-4b96-abd5-6226440e5dbc.html,,oral,LD50,"3,150 mg/kg bw",no adverse effect observed, 2-tert-butylcyclohexyl ethyl carbonate,67801-64-3," Repeated dose toxicity oral: NOAEL ≥ 500 mg/kg bw/d (OECD 422, RA, K, Rel.2) (equivalent to an overall intake of at least 437 mg/kg bw/day in female rats and 505 mg/kg bw/day in male rats) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2054792-c2ae-4c1f-aac1-1eab064fa9cd/documents/e855632e-634b-4a60-9f2f-ff6a149fc3d3_020c4ced-51cf-40e9-a862-15c12db7eef6.html,,,,,, 2-tert-butylcyclohexyl ethyl carbonate,67801-64-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2054792-c2ae-4c1f-aac1-1eab064fa9cd/documents/e855632e-634b-4a60-9f2f-ff6a149fc3d3_020c4ced-51cf-40e9-a862-15c12db7eef6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat 2-tert-butylcyclohexyl ethyl carbonate,67801-64-3," Acute toxicity: oral: LD50 > 2000 mg/kg bw (sim. to OECD 401, K, rel. 1) Acute toxicity: dermal: LD50 > 5000 mg/kg bw (sim. to OECD 402, RA, rel. 4) Acute toxicity: inhlalation: waiver ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2054792-c2ae-4c1f-aac1-1eab064fa9cd/documents/9661348b-7428-4c0c-82ba-c99f8c7e878d_020c4ced-51cf-40e9-a862-15c12db7eef6.html,,,,,, 2-tert-butylcyclohexyl ethyl carbonate,67801-64-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2054792-c2ae-4c1f-aac1-1eab064fa9cd/documents/9661348b-7428-4c0c-82ba-c99f8c7e878d_020c4ced-51cf-40e9-a862-15c12db7eef6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-tert-butylcyclohexyl ethyl carbonate,67801-64-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2054792-c2ae-4c1f-aac1-1eab064fa9cd/documents/9661348b-7428-4c0c-82ba-c99f8c7e878d_020c4ced-51cf-40e9-a862-15c12db7eef6.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-tert-butyl-4-methoxyphenol,121-00-6," Repeated dose toxicity: Oral   In a 90 days repeat dose toxicity study, male Sprague-Dawley rats were exposed to the test chemical by oral gavage in the concentrations of 0 or 50 mg/kg/day. The results showed only effect in Morris Water Maze (Hidden platform MWM and Probe trial), MDA content and SOD activity when exposed to 50 mg/kg/day the test chemical alone. In combination with 2 mg/kg/day B(a)P, the results showed an improved performance in MWM compared to the rats in the B(a)P group, demonstrating that the test chemical has a protective action against the harmful effect of B(a)P. The MDA level of rats in B(a)P-test chemical-was lower, and SOD activity was higher than in the B(a)P-group, thus also showing positive effect against B(a)P damage. The activity of ATPase improved significantly in B(a)P-test chemical-treated rats, which indicates that the test chemical plays a positive role in energy metabolism. Therefore, no observed adverse effect level (NOAEL) was considered to be 50 mg/kg body weight/ day in male Sprague-Dawley rat when exposed to the test chemical by oral gavage on a daily basis for 90 days. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1518a9ce-d8ff-4f1b-9541-e187f4240d50/documents/d66fee52-3afa-47f6-87ae-b2ca95a06f6a_bb36a54d-d780-4362-bd98-4fdb0111312a.html,,,,,, 2-tert-butyl-4-methoxyphenol,121-00-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1518a9ce-d8ff-4f1b-9541-e187f4240d50/documents/d66fee52-3afa-47f6-87ae-b2ca95a06f6a_bb36a54d-d780-4362-bd98-4fdb0111312a.html,Chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 2-tert-butyl-4-methoxyphenol,121-00-6," Acute Toxicity:Oral Under the condition of the study, the acute oral LD50 value of test chemical was considered to be >2000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of test chemical when administered via oral route in Wistar rats falls into the “Category Not classified” criteria of CLP. Acute toxicity:Inhalation: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account the low vapour  pressure of the test substance, which is reported as 0.00234 mm Hg. Thus, exposure to inhalable dust,  mist and vapour of the chemical is highly unlikely.  The particle size distribution of the test substance was found to vary in the size of 106-150 µm, so the potential for the generation of inhalable forms is low.Therefore this study is considered for waiver. Acute toxicity:Dermal The acute dermal median lethal dose of test chemical was >2000 mg/kg body weight.Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the test chemical does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1518a9ce-d8ff-4f1b-9541-e187f4240d50/documents/05fd7190-8469-4788-adb2-d9ebacfe8412_bb36a54d-d780-4362-bd98-4fdb0111312a.html,,,,,, 2-tert-butyl-4-methoxyphenol,121-00-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1518a9ce-d8ff-4f1b-9541-e187f4240d50/documents/05fd7190-8469-4788-adb2-d9ebacfe8412_bb36a54d-d780-4362-bd98-4fdb0111312a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-tert-butyl-4-methoxyphenol,121-00-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1518a9ce-d8ff-4f1b-9541-e187f4240d50/documents/05fd7190-8469-4788-adb2-d9ebacfe8412_bb36a54d-d780-4362-bd98-4fdb0111312a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-(p-cumenyl)-2-methylpropionaldehyde,6658-48-6," - A 28-Day Study of SILVIAL by dermal exposure of Wistar Rats study performed in 2017/2018 to determine the potential toxicity of SILVIAL, when given dermally for 28 days to Wistar rats and evaluate the No Observed Adverse Effect Level (NOAEL) . ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11466160-4c82-4bc7-8807-a0eb739dab55/documents/a2d22946-a565-4fc0-a31e-ce6e72252736_584df292-2dd0-4830-ac87-0bfc095373af.html,,,,,, 3-(p-cumenyl)-2-methylpropionaldehyde,6658-48-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11466160-4c82-4bc7-8807-a0eb739dab55/documents/a2d22946-a565-4fc0-a31e-ce6e72252736_584df292-2dd0-4830-ac87-0bfc095373af.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,300 mg/kg bw/day,,rat 3-(p-cumenyl)-2-methylpropionaldehyde,6658-48-6,WoE approach based on Klimish 4 _1 page study summary : - Acute Oral toxicity in rats on Rhodial abstract_ dated on 1977_LD50 (Oral) >5000 mg/Kg bw - Acute Dermal toxicity in rabbits on Rhodial abstract_ dated on 1977_LD50 (dermal) >5000 mg/Kg bw - Acute Inhalation toxicity in rats (Klimish 1) dated on 2018 - LC50>5.14 mg/L in males as females rats ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11466160-4c82-4bc7-8807-a0eb739dab55/documents/0ccb5c07-c18a-49f1-8d61-41abc21b089e_584df292-2dd0-4830-ac87-0bfc095373af.html,,,,,, 3-(p-cumenyl)-2-methylpropionaldehyde,6658-48-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11466160-4c82-4bc7-8807-a0eb739dab55/documents/0ccb5c07-c18a-49f1-8d61-41abc21b089e_584df292-2dd0-4830-ac87-0bfc095373af.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 3-(p-cumenyl)-2-methylpropionaldehyde,6658-48-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11466160-4c82-4bc7-8807-a0eb739dab55/documents/0ccb5c07-c18a-49f1-8d61-41abc21b089e_584df292-2dd0-4830-ac87-0bfc095373af.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "3-ethoxy-1,1,5-trimethylcyclohexane",67583-77-1," Repeated dose toxicity, oral route (OECD 422, GLP, K, rel. 1): Parental NOAEL (males) for systemic effects = 15000 ppm (nominal); 729 mg/kg bw/day (actual dose received - highest dose tested) Parental NOAEL (females) for systemic effects = 15000 ppm (nominal); 725 mg/kg bw/day (actual dose received - highest dose tested) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8fca543-8983-4f51-bf91-e2cfe68c02b3/documents/98a44e73-83fe-4b0a-8760-fbf9d5ed937f_61adfab1-d351-4e52-9e94-6a69cdeef694.html,,,,,, "3-ethoxy-1,1,5-trimethylcyclohexane",67583-77-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8fca543-8983-4f51-bf91-e2cfe68c02b3/documents/98a44e73-83fe-4b0a-8760-fbf9d5ed937f_61adfab1-d351-4e52-9e94-6a69cdeef694.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,725 mg/kg bw/day,,rat "3-ethoxy-1,1,5-trimethylcyclohexane",67583-77-1,- Acute toxicity: oral: LD50 > 2000 mg/kg bw- Acute toxicity: dermal: LD50 > 2000 mg/kg bw- Acute toxicity: inhalation: waiving ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8fca543-8983-4f51-bf91-e2cfe68c02b3/documents/348a16e6-4f92-4c8e-bd42-d6aeeb055edd_61adfab1-d351-4e52-9e94-6a69cdeef694.html,,,,,, "3-ethoxy-1,1,5-trimethylcyclohexane",67583-77-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8fca543-8983-4f51-bf91-e2cfe68c02b3/documents/348a16e6-4f92-4c8e-bd42-d6aeeb055edd_61adfab1-d351-4e52-9e94-6a69cdeef694.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-ethoxy-1,1,5-trimethylcyclohexane",67583-77-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8fca543-8983-4f51-bf91-e2cfe68c02b3/documents/348a16e6-4f92-4c8e-bd42-d6aeeb055edd_61adfab1-d351-4e52-9e94-6a69cdeef694.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, cis-hex-3-en-1-ol,928-96-1," Repeat dose toxicity via the oral route (OECD 422): Based on the results of the study, a NOAEL for general toxicity in males and females was considered to be 1000 mg/kg/day, the highest dose level tested. Repeat dose toxicity via the oral route (comparable to OECD 408): The NOEL was found to be 1250 ppm, which is equivalent to an intake of approximately 120- 150 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14ce9eab-5937-4e6e-9a47-205943e4894f/documents/IUC5-37c2fbd8-63d1-4fa1-8d3a-da8a32d1688e_a5a0ea4d-0c5b-4c7c-b3ff-a4155c0d59ef.html,,,,,, cis-hex-3-en-1-ol,928-96-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14ce9eab-5937-4e6e-9a47-205943e4894f/documents/IUC5-37c2fbd8-63d1-4fa1-8d3a-da8a32d1688e_a5a0ea4d-0c5b-4c7c-b3ff-a4155c0d59ef.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat cis-hex-3-en-1-ol,928-96-1, Acute oral toxicity: The test substance was found to have a LD50 of 4615 mg/kg (key study result). Acute inhalation toxicity: The test substance was found to have an LC50 of >4.99 mg/L. Acute dermal toxicity: New test not required. Literature data reports LD50 of >5000 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14ce9eab-5937-4e6e-9a47-205943e4894f/documents/IUC5-683036a2-269b-466a-b0c8-5149b025352a_a5a0ea4d-0c5b-4c7c-b3ff-a4155c0d59ef.html,,,,,, cis-hex-3-en-1-ol,928-96-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14ce9eab-5937-4e6e-9a47-205943e4894f/documents/IUC5-683036a2-269b-466a-b0c8-5149b025352a_a5a0ea4d-0c5b-4c7c-b3ff-a4155c0d59ef.html,,oral,LD50,"4,615 mg/kg bw",no adverse effect observed, "3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate",1115-20-4,In an oral 90-d study (OECD408) the NOAEL for HPN was 300 mg/kg bw/d. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77c36644-33b6-4240-8c43-1ab1ff73c3ba/documents/IUC5-356beeea-5ca4-4960-9c3d-2cd95623f203_46ddb81b-fe7a-4eec-ae21-7848d01fe6e6.html,,,,,, "3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate",1115-20-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77c36644-33b6-4240-8c43-1ab1ff73c3ba/documents/IUC5-356beeea-5ca4-4960-9c3d-2cd95623f203_46ddb81b-fe7a-4eec-ae21-7848d01fe6e6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate",1115-20-4,oral: LD50 (rat) = 8000 mg/kg bwinhalation risk test: no mortality ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77c36644-33b6-4240-8c43-1ab1ff73c3ba/documents/IUC5-d326fcda-ca6c-4652-a7bf-a660b3eee729_46ddb81b-fe7a-4eec-ae21-7848d01fe6e6.html,,,,,, "3-hydroxy-2,2-dimethylpropyl 3-hydroxy-2,2-dimethylpropionate",1115-20-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77c36644-33b6-4240-8c43-1ab1ff73c3ba/documents/IUC5-d326fcda-ca6c-4652-a7bf-a660b3eee729_46ddb81b-fe7a-4eec-ae21-7848d01fe6e6.html,,oral,LD50,"8,000 mg/kg bw",adverse effect observed, 3-methylbut-3-en-1-ol,763-32-6," Under the conditions of this screening study, 50 mg/kg bw/day was the no-observed-adverse-effect-level (NOAEL) for males systemic toxicity and the lowest-observed-adverse-effect-level (LOAEL) for F0 female systemic toxicity (pregnant and lactating with more extended dosing period). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a689ee57-d136-42f3-b33b-08393087dd99/documents/df8bd6a6-48f9-4837-8265-688de6736852_84f0405c-890a-483e-a990-dc4785611adf.html,,,,,, 3-methylbut-3-en-1-ol,763-32-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a689ee57-d136-42f3-b33b-08393087dd99/documents/df8bd6a6-48f9-4837-8265-688de6736852_84f0405c-890a-483e-a990-dc4785611adf.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,50 mg/kg bw/day,,rat 3-methylbut-3-en-1-ol,763-32-6,"ORAL LD50, rat > 5440 mg/kg bw (BASF, 1968)DERMAL No data are available.INHALATION No mortality was observed when 12 rats were exposed for 8 hours to an  atmosphere that had been saturated at 20°C with the volatile parts of the  compound. The nominal concentration of the test substance was 21.5 mg/l. (BASF, 1968) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a689ee57-d136-42f3-b33b-08393087dd99/documents/9584b029-002d-4194-9f95-5c918c75d5c0_84f0405c-890a-483e-a990-dc4785611adf.html,,,,,, 3-methylbut-3-en-1-ol,763-32-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a689ee57-d136-42f3-b33b-08393087dd99/documents/9584b029-002d-4194-9f95-5c918c75d5c0_84f0405c-890a-483e-a990-dc4785611adf.html,,oral,LD50,"5,440 mg/kg bw",adverse effect observed, 3-methoxybutan-1-ol,2517-43-3,"Taking information into account both for putative metabolites and for closely related structural analogues of 3-methoxybutan-1-ol highlights the significant extent of the toxicology database that is available to assess the repeat-dose toxicity profile. An understanding of the likely metabolic fate, and hence systemic exposure profiles of these substances, underpins the repeat-dose toxicity profile. The repeat-dose toxicity of the structural analogue of 3-methoxybutan-1-ol, namely 3-methoxy-3-methyl-1-butanol, has been assessed in guideline 90-day studies. The lowest NOEL was 60 mg/kg/day (LEL=200mg/kg/day) and was based on reversible liver/kidney effects (in the absence of histopathological change) and considered by the authors as non-adverse. Although such effects have not been reported in any short-term 3-methoxybutan-1-ol study, as this is the lowest NOEL reported for any structural analogues of 3-methoxybutan-1-ol considered in this review, it is used albeit as a conservative surrogate NOEL for 3-methoxybutan-1-ol. Thus the NOEL for 3-methoxybutan-1-ol repeat-dose toxicity is considered to be 60 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9efe97dd-4fca-4373-870c-2aa9dcd83a77/documents/IUC5-1127fc98-830a-47b3-95c2-d7924c6ba5b9_37764956-615f-49fe-a88e-cc97aed9df2f.html,,,,,, 3-methoxybutan-1-ol,2517-43-3,"There are sufficient data to assess the acute toxicity of 3-methoxybutan-1-ol and it is considered to have low acute toxicity by oral, inhalation and dermal routes of exposure. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9efe97dd-4fca-4373-870c-2aa9dcd83a77/documents/IUC5-4e0a4674-2270-4da7-aaa4-e359ae967449_37764956-615f-49fe-a88e-cc97aed9df2f.html,,,,,, "3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-3-en-2-one",65113-95-3,"An OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents) was performed to GLP, a synopsis is given below. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2751464b-7bed-41bd-be15-498e13008469/documents/IUC5-f01299f7-867c-4910-ac17-c3e2bc9cf8ad_f4980ed6-7102-4848-bd87-c9c512c5723a.html,,,,,, "3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-3-en-2-one",65113-95-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2751464b-7bed-41bd-be15-498e13008469/documents/IUC5-f01299f7-867c-4910-ac17-c3e2bc9cf8ad_f4980ed6-7102-4848-bd87-c9c512c5723a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-3-en-2-one",65113-95-3,Acute Toxicity - Oral study ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2751464b-7bed-41bd-be15-498e13008469/documents/IUC5-21ff371c-c7b1-4e7d-bdc8-05e236bd1fd6_f4980ed6-7102-4848-bd87-c9c512c5723a.html,,,,,, "3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-3-en-2-one",65113-95-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2751464b-7bed-41bd-be15-498e13008469/documents/IUC5-21ff371c-c7b1-4e7d-bdc8-05e236bd1fd6_f4980ed6-7102-4848-bd87-c9c512c5723a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol",67801-20-1,"A OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents) was performed to GLP, a synopsis is given below. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75639cc5-9c45-4021-bd32-fa32d8cd5d27/documents/IUC5-a60f2188-5036-4d03-9a63-5ce001224a70_eebe1866-0b82-42e3-a58d-4f3ac093eaf9.html,,,,,, "3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol",67801-20-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75639cc5-9c45-4021-bd32-fa32d8cd5d27/documents/IUC5-a60f2188-5036-4d03-9a63-5ce001224a70_eebe1866-0b82-42e3-a58d-4f3ac093eaf9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol",67801-20-1,Acute Oral Toxicity: Key study >1000 mg/kg/day. Supporting study: >5000 mg/kg/dayAcute Dermal Toxicity: >2000 mg/kg/day.Acute Inhalation Toxicity: Waiver based on relatively harmless levels of acute toxicity via the oral and dermal routes. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75639cc5-9c45-4021-bd32-fa32d8cd5d27/documents/IUC5-f17c06f2-0de8-44f4-bd21-4dcfdb761431_eebe1866-0b82-42e3-a58d-4f3ac093eaf9.html,,,,,, "3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol",67801-20-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75639cc5-9c45-4021-bd32-fa32d8cd5d27/documents/IUC5-f17c06f2-0de8-44f4-bd21-4dcfdb761431_eebe1866-0b82-42e3-a58d-4f3ac093eaf9.html,,oral,LD50,"1,000 mg/kg bw",, "3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-ol",67801-20-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75639cc5-9c45-4021-bd32-fa32d8cd5d27/documents/IUC5-f17c06f2-0de8-44f4-bd21-4dcfdb761431_eebe1866-0b82-42e3-a58d-4f3ac093eaf9.html,,dermal,LD50,"2,000 mg/kg bw",, 3-methyl-5-phenylpent-2-enenitrile,93893-89-1,"A repeated oral dose toxicity study was conducted in rats (key study). A NOAEL of 50 mg/kg bw/day for both male and female rats was established.   In a Reproduction/Developmental Toxicity Screening Test in Sprague-Dawley rats according to OECD guideline 421, the NOAEL for in general toxicity of was determined to be 12.5 mg/kg/day in both sexes. For reproductive toxicity, the NOAEL was >200 mg/kg bw/day (males) and 50 mg/kg bw/day (females) and for developmental toxicity, the NOAEL was determined to be 50 mg/kg/day (both sexes).   A supporting study was conducted as a dose finding study for a 4-week repeated dose toxicity study in rats. It was established that 250 mg/kg bw/day should be used as the high dose level in the 4-week dose toxicity study.   Overall conclusion: The lowest systemic NOAEL from the Reproduction/Developmental Toxicity Screening Test (OECD guideline 421) was used for risk assessment. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d93d1616-302c-42ca-9b08-d14e3ed2b866/documents/ff71b939-0dd8-4bcc-b896-8dd04a4f0aeb_77ca10c5-f127-4ad8-ae84-06b1e935a3e7.html,,,,,, 3-methyl-5-phenylpent-2-enenitrile,93893-89-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d93d1616-302c-42ca-9b08-d14e3ed2b866/documents/ff71b939-0dd8-4bcc-b896-8dd04a4f0aeb_77ca10c5-f127-4ad8-ae84-06b1e935a3e7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,12.5 mg/kg bw/day,,rat 3-methyl-5-phenylpent-2-enenitrile,93893-89-1,Oral: The oral LD50 of the test substance in rat was established to be in the range from 300 to 2000 mg/kg bw. Inhalation: The inhalation LD50 of the test substance in rat was found to be 5.31 mg/L aerosol. Dermal: The dermal LD50 of the test substance in rats was determined to be greater than 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d93d1616-302c-42ca-9b08-d14e3ed2b866/documents/343bfc6c-3372-4c0f-a13a-7d793ae377c3_77ca10c5-f127-4ad8-ae84-06b1e935a3e7.html,,,,,, 3-methyl-5-phenylpent-2-enenitrile,93893-89-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d93d1616-302c-42ca-9b08-d14e3ed2b866/documents/343bfc6c-3372-4c0f-a13a-7d793ae377c3_77ca10c5-f127-4ad8-ae84-06b1e935a3e7.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, 3-methyl-5-phenylpent-2-enenitrile,93893-89-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d93d1616-302c-42ca-9b08-d14e3ed2b866/documents/343bfc6c-3372-4c0f-a13a-7d793ae377c3_77ca10c5-f127-4ad8-ae84-06b1e935a3e7.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 3-methyl-5-phenylpent-2-enenitrile,93893-89-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d93d1616-302c-42ca-9b08-d14e3ed2b866/documents/343bfc6c-3372-4c0f-a13a-7d793ae377c3_77ca10c5-f127-4ad8-ae84-06b1e935a3e7.html,,inhalation,LC50,"5,310 mg/m3",no adverse effect observed, Octan-3-ol,589-98-0," Repeated dose toxicity: Oral 90 days repeated dose oral toxicity study was performed to determine the toxic nature of Octan-3-ol. The study was performed using male and female Wistar rats. The test chemical was dissolved in soyabean oil and used at dose level of 0, 25, 100 or 400 mg/Kg/day. During the study period, the animals were observed for mortality, clinical signs, food consumption, water consumption, body weight and organ weight changes, hematology, clinical chemistry parameters and the treated animals were subjected to gross and histopathology. Two animals in the low-dose group (25 mg/kg/day) died due to accidental intratracheal dosing and were excluded from the study. No effects on the clinical appearance of the rats attributed to dosing were observed. An increase in food consumption and a statistically significant increase in water uptake was observed among rats dosed with the test chemical. Statistically significant increases in terminal body weight were found for female rats dosed with octan-3-ol (100 and 400 mg/Kg/day), compared with the control group. Absolute and relative liver weights of the400 mg/kg/day dosed male rats were significantly higher than those of the control. A slight increase in absolute and relative liver weight was observed in the female rats dosed with 100 and 400 dosed groups compared with the controls. However, the changes were not dose related and only reached statistical significance for the 100 mg/kg/day dosed group (absolute liver weight). The relative heart weight was significantly increased in all dosed male rats except for the 400 mg/Kg/day dose octan-3-ol rats. No effect on relative heart weight was observed in female rats. No further treatment-related changes in organ weights were observed. Treatment-related effects were observed in the kidneys, but in males only. The incidences of tubular karyomegaly and luminal desquamation of tubular epithelial cells in the cortex were increased in rats dosed with the 100 and 400 mg/Kg/day of octan-3-ol, although the incidence of tubular karyomegaly in the 100 mg/Kg/day -dose octan-3-ol group was not significantly increased (P=0.08). The lesions were minimal to mild. In all other organs examined, no treatment-related changes were observed. Based on the observations made, the No observed adverse effect level (NOAEL) for the test compound octan-3-ol is considered to be 25 mg/Kg/day. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6051772a-4d68-4207-b1b3-ed915590bcab/documents/b25fe75f-1c3c-4eba-aa29-b3afb6d078c1_3fd2b029-7bd8-4cb3-b337-0de7023ef6ba.html,,,,,, Octan-3-ol,589-98-0,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6051772a-4d68-4207-b1b3-ed915590bcab/documents/b25fe75f-1c3c-4eba-aa29-b3afb6d078c1_3fd2b029-7bd8-4cb3-b337-0de7023ef6ba.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Octan-3-ol,589-98-0," Acute Oral Toxicity:  In Acute oral toxicity,LD50 value for target substance 3-Octanol (589-98-0) was considered to be >5000 mg/kg bw ,and for differentstudies available on the similar read across substance Heptan-2-ol (543-49-7) was considered to be 2580 mg/kg bw and for 2-Octanol (123-96-6) was considered to be >3200 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 3-Octanol (589-98-0) cannot be classified for acute oral toxicity. Acute Dermal Toxicity: In Acute dermal toxicity, LD50 value for target substance 3-Octanol (589-98-0) was considered to be >5000 mg/kg bw,and for differentstudies available on structurally similar read across substance Heptan-3-ol (589-82-2) was considered to be 4360 mg/kg bw and for 3-Pentanol (584-02-1) was considered to be 2520 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 3-Octanol (589-98-0) cannot be classified for acute dermal toxicity. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6051772a-4d68-4207-b1b3-ed915590bcab/documents/b7078fdc-ee91-494f-8a15-2b4004f9ddb7_3fd2b029-7bd8-4cb3-b337-0de7023ef6ba.html,,,,,, Octan-3-ol,589-98-0,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6051772a-4d68-4207-b1b3-ed915590bcab/documents/b7078fdc-ee91-494f-8a15-2b4004f9ddb7_3fd2b029-7bd8-4cb3-b337-0de7023ef6ba.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Octan-3-ol,589-98-0,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6051772a-4d68-4207-b1b3-ed915590bcab/documents/b7078fdc-ee91-494f-8a15-2b4004f9ddb7_3fd2b029-7bd8-4cb3-b337-0de7023ef6ba.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, 3-(p-cumenyl)propionaldehyde,7775-00-0, Acute oral toxicity of Cyclemax: a study according to OECD TG 423 was performed: LD50 > 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0140ac74-ada5-4dbf-80ba-874fd181eab5/documents/d5574f41-0707-4ea0-b82e-a04324d0d677_6159388a-f771-4214-b112-5fe81c066d05.html,,,,,, 3-phenylbutyraldehyde,16251-77-7,"Acute Toxicity (oral, rat, OECD 401): > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b588e38-22d1-4099-89ae-3730ba833c90/documents/IUC5-3f10cd47-93f4-44e1-9701-3d611778b9ec_6d7c664a-e215-42fb-9e08-35b3b3004997.html,,,,,, 3-phenylbutyraldehyde,16251-77-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b588e38-22d1-4099-89ae-3730ba833c90/documents/IUC5-3f10cd47-93f4-44e1-9701-3d611778b9ec_6d7c664a-e215-42fb-9e08-35b3b3004997.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4,4'-isopropylidenediphenol",80-05-7," Oral:  Multi generational studies in mice and rats have shown that Bisphenol A affects kidney and liver weight in parental animals dosed with 50 – 600 mg/kg bw/d and its progeny. This finding is supported by the recently conducted CLARITY Core study. It revealed no conclusive evidence for systemic toxicity in rats exposed up to 25 mg BPA/kg bw/d (Stop-Dose & Continuous Dose). Given that kidney and liver weight are considered as relevant systemic effects for human risk assessment a BMDL10 for mean relative kidney weight of 8960 µg/kg bw/d in male mice of the F0 generation was taken as starting point according to EFSA’s Scientific opinion on BPA in 2015.   Inhalation:  In rats exposed daily to airborne Bisphenol A for 13 weeks there was a NOAEC of 10 mg/m3, with mild olfactory epithelium inflammation at 50 and 150 mg/m3. There was no evidence of systemic toxicity in this study.  ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d9de292-990f-403c-82a8-096416da9af0/documents/6df140a2-ccf3-4f4f-a060-63730be250c6_f62ffbdd-feb0-4774-84fa-5ab9f7ffb22e.html,,,,,, "4,4'-isopropylidenediphenol",80-05-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d9de292-990f-403c-82a8-096416da9af0/documents/6df140a2-ccf3-4f4f-a060-63730be250c6_f62ffbdd-feb0-4774-84fa-5ab9f7ffb22e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,mouse "4,4'-isopropylidenediphenol",80-05-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d9de292-990f-403c-82a8-096416da9af0/documents/6df140a2-ccf3-4f4f-a060-63730be250c6_f62ffbdd-feb0-4774-84fa-5ab9f7ffb22e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,150 mg/m3,,rat "4,4'-isopropylidenediphenol",80-05-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d9de292-990f-403c-82a8-096416da9af0/documents/6df140a2-ccf3-4f4f-a060-63730be250c6_f62ffbdd-feb0-4774-84fa-5ab9f7ffb22e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,10 mg/m3,adverse effect observed,rat "4,4'-isopropylidenediphenol",80-05-7,"Bisphenol A is of low acute toxicity by all routes of exposure relevant to human health. Oral LD50 values beyond 2,000 mg/kg are reported in rodents, and dermal LD50 values above 2,000 mg/kg are indicated in the rabbit. For inhalation, a 6-hour exposure to 170 mg/m3 (the highest attainable concentration) produced no death in rats; slight and transient slight nasal tract epithelial damage was observed.  ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d9de292-990f-403c-82a8-096416da9af0/documents/15858f34-4f57-4177-9810-6ae7467fc2ca_f62ffbdd-feb0-4774-84fa-5ab9f7ffb22e.html,,,,,, "4,4'-isopropylidenediphenol",80-05-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d9de292-990f-403c-82a8-096416da9af0/documents/15858f34-4f57-4177-9810-6ae7467fc2ca_f62ffbdd-feb0-4774-84fa-5ab9f7ffb22e.html,,oral,LD50,"4,100 mg/kg bw",adverse effect observed, "4,4'-isopropylidenediphenol",80-05-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d9de292-990f-403c-82a8-096416da9af0/documents/15858f34-4f57-4177-9810-6ae7467fc2ca_f62ffbdd-feb0-4774-84fa-5ab9f7ffb22e.html,,dermal,LD50,"3,000 mg/kg bw",adverse effect observed, "4,4'-isopropylidenediphenol",80-05-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d9de292-990f-403c-82a8-096416da9af0/documents/15858f34-4f57-4177-9810-6ae7467fc2ca_f62ffbdd-feb0-4774-84fa-5ab9f7ffb22e.html,,inhalation,discriminating conc.,170 mg/m3,adverse effect observed, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane",25068-38-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e39f7d34-635c-471a-a161-7d336353f525/documents/IUC5-05c5bd00-c8d1-4963-b5c9-a905aa85bcb6_1c144fec-239f-4b56-86b7-3a52b7c072bc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,8-dimethyl-4,9-decadienal",71077-31-1,Acute oral toxicity (OECD TG 401): >5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d7ad357-ea2c-4491-9810-2b54ccfe6545/documents/IUC5-ca201ae6-7d8a-46b0-b584-0e1a53849b8b_97c2e9bf-5b6c-4d37-8424-6f8369ae5758.html,,,,,, 5-amino-o-cresol,2835-95-2," According to the results of the in vivo key studies (Acceptable study followed basic scientific principle, Klimisch 2). The NOAEL No Observed Adverse Effect Level was defined at 180 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b586ebbf-d88e-4436-a8ca-0afed0251a41/documents/d7f9c30c-990e-4f84-b003-0e6e27cdd846_2c45b3a5-ce90-4012-90b2-2a9be612d8d1.html,,,,,, 5-amino-o-cresol,2835-95-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b586ebbf-d88e-4436-a8ca-0afed0251a41/documents/d7f9c30c-990e-4f84-b003-0e6e27cdd846_2c45b3a5-ce90-4012-90b2-2a9be612d8d1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,180 mg/kg bw/day,,rat 5-amino-o-cresol,2835-95-2," According to the results of the key study (Klimisch 2), the Lethal Dose of the registered substance 4 -amino-2 -Hydroxytoluene was defined as 3600 mg/kg bw. Hence, the substance was not classified for Acute Hazard Oral according to CLP regulation. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b586ebbf-d88e-4436-a8ca-0afed0251a41/documents/43e3dd20-b504-4b6b-82ae-2c7e39e0f6d4_2c45b3a5-ce90-4012-90b2-2a9be612d8d1.html,,,,,, 5-amino-o-cresol,2835-95-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b586ebbf-d88e-4436-a8ca-0afed0251a41/documents/43e3dd20-b504-4b6b-82ae-2c7e39e0f6d4_2c45b3a5-ce90-4012-90b2-2a9be612d8d1.html,,oral,LD50,"3,600 mg/kg bw",adverse effect observed, 5-amino-o-cresol,2835-95-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b586ebbf-d88e-4436-a8ca-0afed0251a41/documents/43e3dd20-b504-4b6b-82ae-2c7e39e0f6d4_2c45b3a5-ce90-4012-90b2-2a9be612d8d1.html,,dermal,LD50,"5,688 mg/kg bw",no adverse effect observed, 5-amino-o-cresol,2835-95-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b586ebbf-d88e-4436-a8ca-0afed0251a41/documents/43e3dd20-b504-4b6b-82ae-2c7e39e0f6d4_2c45b3a5-ce90-4012-90b2-2a9be612d8d1.html,,inhalation,LC50,"42,570 mg/m3",no adverse effect observed, 4-amino-3-nitrophenol,610-81-1," Based on the results of the key studies (Hill, 1992, Klimisch 1, OECD 407 ; Brownlie, 1997, Klimisch 1, OECD 408) , the No Observed Adverse Effect Level (NOAEL) of the test article 4 -amino-3 -nitrophenol when administered orally by gavage to rats was defined at 250 mg/kg/day. The Test Article was not classififed for STOT-RE according to the CLP regulation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9807dcc1-2300-49bc-8fb8-9f6edee9e118/documents/469a3d44-a031-4587-80f1-9405557f512f_bc465ea6-2075-439e-9c69-e30d561af782.html,,,,,, 4-amino-3-nitrophenol,610-81-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9807dcc1-2300-49bc-8fb8-9f6edee9e118/documents/469a3d44-a031-4587-80f1-9405557f512f_bc465ea6-2075-439e-9c69-e30d561af782.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 4-amino-3-nitrophenol,610-81-1," Based on the result of the key study (Clouzeau, OECD 401, Klimisch 1, GLP), the LD50 value of the test article 4-amino-3-nitrophenol was between the range of 500 mg/kg and 1000 mg/kg. Hence, according to the CLP regulation, the test item was classified as Category 4 for Acute Oral Hazard. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9807dcc1-2300-49bc-8fb8-9f6edee9e118/documents/e8a0dbac-121f-45b1-be00-c119fc4e5b99_bc465ea6-2075-439e-9c69-e30d561af782.html,,,,,, 4-amino-3-nitrophenol,610-81-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9807dcc1-2300-49bc-8fb8-9f6edee9e118/documents/e8a0dbac-121f-45b1-be00-c119fc4e5b99_bc465ea6-2075-439e-9c69-e30d561af782.html,,oral,LD50,500 mg/kg bw,adverse effect observed, 4-amino-m-cresol,2835-99-6," According to the result of the key study (Klimisch 1, OECD guideline 408 method, GLP compliant), the substance 1-Hydroxy-3-methyl-4-aminobenzol-sulfate induced slight toxicity in rats treated for 90 days by oral route. Effects observed were: increase in absolute spleen weight in the high dose group. The NOAEL (No observe adverse effect level) was defined as 60 mg/kg/day. Based on this result on the sulfate form, the converted NOAEL for the registered substance 4 -amino-3-methylphenol was defined at 42.6 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0499a05f-ecbf-42ae-917f-ddf7002dde39/documents/23484d8c-f992-439b-9765-663760d05a9a_d2ff3c31-da8a-4fff-8b7d-ba68afd1b78f.html,,,,,, 4-amino-m-cresol,2835-99-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0499a05f-ecbf-42ae-917f-ddf7002dde39/documents/23484d8c-f992-439b-9765-663760d05a9a_d2ff3c31-da8a-4fff-8b7d-ba68afd1b78f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,42.6 mg/kg bw/day,,rat 4-amino-m-cresol,2835-99-6," According to the results of the two keys studies performed, the Lethal Dose 50 was defined as 870 mg/kg bw on rats treated by gavage. Hence, the test item was classified as Category 4 for Acute toxicity hazard by oral route according to GHS criteria and regulation. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0499a05f-ecbf-42ae-917f-ddf7002dde39/documents/f1dcac41-b40e-43dc-b251-9a860b37e924_d2ff3c31-da8a-4fff-8b7d-ba68afd1b78f.html,,,,,, 4-amino-m-cresol,2835-99-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0499a05f-ecbf-42ae-917f-ddf7002dde39/documents/f1dcac41-b40e-43dc-b251-9a860b37e924_d2ff3c31-da8a-4fff-8b7d-ba68afd1b78f.html,,oral,LD50,870 mg/kg bw,adverse effect observed, 4-amino-m-cresol,2835-99-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0499a05f-ecbf-42ae-917f-ddf7002dde39/documents/f1dcac41-b40e-43dc-b251-9a860b37e924_d2ff3c31-da8a-4fff-8b7d-ba68afd1b78f.html,,dermal,LD50,"2,409 mg/kg bw",no adverse effect observed, 4-amino-m-cresol,2835-99-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0499a05f-ecbf-42ae-917f-ddf7002dde39/documents/f1dcac41-b40e-43dc-b251-9a860b37e924_d2ff3c31-da8a-4fff-8b7d-ba68afd1b78f.html,,inhalation,LC50,0.012 mg/m3,no adverse effect observed, 4-chlororesorcinol,95-88-5,"Repeated dose : OralIn subchronic toxicity study of 4-Chlororesorcinol on male and female HanBrl: Wistar(SPF) rats, the NOAEL was considered to be 70 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd2a6e86-7ae4-4d66-b95d-af030495f78e/documents/583f6881-07da-4544-b412-ea7d23e64e19_77667a8a-658f-4de9-b196-4bc7c3fbef7e.html,,,,,, 4-chlororesorcinol,95-88-5,4-chlororesorcinol is likely to exhibit the Acute toxicity via oral route. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd2a6e86-7ae4-4d66-b95d-af030495f78e/documents/13b56aa3-45b6-4336-9128-bd992ea08f96_77667a8a-658f-4de9-b196-4bc7c3fbef7e.html,,,,,, 4-chlororesorcinol,95-88-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd2a6e86-7ae4-4d66-b95d-af030495f78e/documents/13b56aa3-45b6-4336-9128-bd992ea08f96_77667a8a-658f-4de9-b196-4bc7c3fbef7e.html,,oral,LD50,369 mg/kg bw,adverse effect observed, 4-chlororesorcinol,95-88-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd2a6e86-7ae4-4d66-b95d-af030495f78e/documents/13b56aa3-45b6-4336-9128-bd992ea08f96_77667a8a-658f-4de9-b196-4bc7c3fbef7e.html,,dermal,LD50,"1,244 mg/kg bw",adverse effect observed, 4-ethylbenzaldehyde,4748-78-1," When the substance was orally administered to rats, the LD50 was 1900 mg/kg in males and 1450 mg/kg in females (mean: 1,680 mg/kg). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41351758-4a18-4e2f-86bf-e0dd8ba32e03/documents/3b37e1ae-f606-4f29-b79f-07e93907eada_954e4584-0be0-4fd3-b9ef-4dd5010b20f9.html,,,,,, 4-ethylbenzaldehyde,4748-78-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41351758-4a18-4e2f-86bf-e0dd8ba32e03/documents/3b37e1ae-f606-4f29-b79f-07e93907eada_954e4584-0be0-4fd3-b9ef-4dd5010b20f9.html,,oral,LD50,"1,450 mg/kg bw",adverse effect observed, 4-ethylphenol,123-07-9,"In a repeated dose 28-Day oral toxicity study equivalent to OECD Technical Guideline 407, doses of 0, 100, 300 and 1000 mg/kg bw/d 4-ethylphenol were administered by gavage to male and female rats. No mortality was observed in any group exposed to 4-ethylphenol. In the 300 mg/kg bw/d dose group an increased organ weight of the liver and a squamous cell hyperplasia in the forestomach was observed in male rats. An expression of toxic symptoms like a staggering gait, salivation was observed in the highest dose group (1000 mg/kg) for male and female rats. Also, low body weights, high relative organ weights for liver or kidney and mucosal and squamous cell hyperplasia in the forestomach were determined. At the end of the recovery period in both, males and females a recovery tendency of the body weight and a reversibility of the other changes was observed According to the observations described, the No-Observed-Effect-Level (NOEL) for male rats was 100 mg/kg bw/d and was 300 mg/kg bw/d for female rats. In a second, supporting repeated 28-Day oral toxicity study equivalent to OECD Technical Guideline 407 young rats were exposed to 4-ethylphenol at the same dose levels. Almost the same toxicological symptoms as salvation, staggering gait and high values of liver weight were observed in the higher dose groups. Based on lesions in the forestomach the NOAEL for rats in this study was derived to be 100 mg/kg bw/d. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7f08f033-91d6-43dd-9a6c-4e4e8b99d117/documents/26d4936b-3ed8-4ac5-8b19-9f0ddec87c05_a5d7df98-80a3-433c-a29c-17820a3d4a5c.html,,,,,, 4-ethylphenol,123-07-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7f08f033-91d6-43dd-9a6c-4e4e8b99d117/documents/26d4936b-3ed8-4ac5-8b19-9f0ddec87c05_a5d7df98-80a3-433c-a29c-17820a3d4a5c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 4-ethylphenol,123-07-9,"Acute toxicity, oral route: In an acute oral toxicity study with rats equivalent to OECD Technical Guideline 401 no mortality occurred after administration of 2000 mg/kg bw of 4-ethylphenol. Furthermore, no abnormalities were recorded at necropsy 14 day after administration. 10 min after administration of 2000 mg/kg clinical signs like rapid breathing and a staggering gait were observed. These symptoms disappeared two hours after administration and no clinical signs were found later until the end of the study except of significantly lower male body-weights. The median lethal dose of the tested material after single oral administration to rats of both sexes, observed over a period of 14 days, is: LD50 (rat): > 2000 mg/kg body weight. According to classification criteria outlined in Regulation (EC) No 1272/2008, 4-ethylphenol is not to be classified with respect to acute oral toxicity.   Acute toxicity, dermal route: Read-Across: No systemic toxicity was observed after single dermal application of 5000 mg/kg bw of 4-ethynylphenol on rabbits and no critical effects were observed. Since a read across from 4-ethynylphenol to 4-ethylphenol is appropriate due to expected comparable toxicological properties, the median lethal dose (LD50) of 4-ethylphenol after single dermal administration is considered >5000 mg/kg body weight. According to classification criteria outlined in Regulation (EC) No 1272/2008, 4-ethylphenol is not to be classified with respect to acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f08f033-91d6-43dd-9a6c-4e4e8b99d117/documents/0066b499-e6a9-45d5-bb39-34c581f5cd26_a5d7df98-80a3-433c-a29c-17820a3d4a5c.html,,,,,, 4-formyl-2-methoxyphenyl isobutyrate,20665-85-4, Oral (Dietary) Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test in the Rat_ Givaudan Key study 2016 ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b67cc80f-c5a1-4d67-b43b-7f9e86adfb45/documents/8c711195-5484-49c7-93c2-2afa52c268c3_75b7082e-e7a3-422c-9967-dfd6da3fb3e8.html,,,,,, 4-formyl-2-methoxyphenyl isobutyrate,20665-85-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b67cc80f-c5a1-4d67-b43b-7f9e86adfb45/documents/8c711195-5484-49c7-93c2-2afa52c268c3_75b7082e-e7a3-422c-9967-dfd6da3fb3e8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-formyl-2-methoxyphenyl isobutyrate,20665-85-4,"Key study:- Givaudan 1983: Acute oral toxicity, no guideline followed (similar to OECD 401), LD50 > 5 mL/kg bw (male and female rats). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b67cc80f-c5a1-4d67-b43b-7f9e86adfb45/documents/cafe580a-8ac5-4d4e-81b1-b049357ad430_75b7082e-e7a3-422c-9967-dfd6da3fb3e8.html,,,,,, 4-formyl-2-methoxyphenyl isobutyrate,20665-85-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b67cc80f-c5a1-4d67-b43b-7f9e86adfb45/documents/cafe580a-8ac5-4d4e-81b1-b049357ad430_75b7082e-e7a3-422c-9967-dfd6da3fb3e8.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 4-hydroxybenzoic acid,99-96-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c254e4a1-697a-4f94-9305-684c43d47ddc/documents/IUC5-49429dc7-5f24-4e6b-b107-75b036a2d9f7_b7671bfa-ed31-4886-b921-37527e83392e.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,60 mg/m3,,rat 4-hydroxybenzoic acid,99-96-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c254e4a1-697a-4f94-9305-684c43d47ddc/documents/IUC5-49429dc7-5f24-4e6b-b107-75b036a2d9f7_b7671bfa-ed31-4886-b921-37527e83392e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-hydroxybenzoic acid,99-96-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c254e4a1-697a-4f94-9305-684c43d47ddc/documents/IUC5-49429dc7-5f24-4e6b-b107-75b036a2d9f7_b7671bfa-ed31-4886-b921-37527e83392e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,60 mg/m3,adverse effect observed,rat 4-hydroxybenzoic acid,99-96-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c254e4a1-697a-4f94-9305-684c43d47ddc/documents/IUC5-3b1d7942-942f-4efc-a804-dfc04d23b8e5_b7671bfa-ed31-4886-b921-37527e83392e.html,,oral,discriminating dose,"2,000 mg/kg bw",, 4-hydroxybenzoic acid,99-96-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c254e4a1-697a-4f94-9305-684c43d47ddc/documents/IUC5-3b1d7942-942f-4efc-a804-dfc04d23b8e5_b7671bfa-ed31-4886-b921-37527e83392e.html,,dermal,discriminating dose,"2,000 mg/kg bw",, 4-hydroxybenzoic acid,99-96-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c254e4a1-697a-4f94-9305-684c43d47ddc/documents/IUC5-3b1d7942-942f-4efc-a804-dfc04d23b8e5_b7671bfa-ed31-4886-b921-37527e83392e.html,,inhalation,discriminating conc.,"7,910 mg/m3",, 4-hydroxybutyl acrylate,2478-10-6," Data for 4 -hydroxybutyl acrylate: -oral:NOAEL = 40 mg/kg bw (BASF, 2022; OECD 408/422) Data from the structural analogue 2-hydroxyethyl acrylate (CAS No. 818-61-1): - oral: NOAEL = approx. 196 – 305 mg/kg bw/day (Sherman rats, no guideline, 100 days, diet) - oral: NOAEL = approx. 125 - 131 mg/kg bw/day (Beagle dogs, no guideline, 97 days, diet) - inhalation: LOAEC = 5 ppm corresponding to approx. 0.024 mg/L (Sherman rats, local effects, no guideline, 28 days, vapour) - inhalation: NOAEC = 0.5 ppm corresponding to approx. 0.0024 mg/L (Sprague-Dawley rats, pneumonia, no guideline, 18 months, vapour) - dermal: no data Data from the structural analogue Methyl acrylate (CAS No. 96-33-3): - oral: NOAEL = 5 mg/kg bw/day (DowChemCo, rats, OECD 408. 90 days, drinking water) - oral: LOAEL = 20 mg/kg bw/day (DowChemCo, rats, OECD 408, 90 days, drinking water) - inhalation: NOAEC = 0.082 mg/L (BASF, rats, OECD 413, 12 weeks, vapour) - inhalation: LOAEC = 0.44 mg/L (BASF, rats, OECD 413, 12 weeks, vapour) - dermal: no data   Data from the structural analogue hydroxypropyl acrylate (CAS No. 25584-83-2): - oral: NOAEL = 150 mg/kg bw/day (Wistar rats, systemic effects, OECD 422, gavage) - oral: NOAEL = 15 mg/kg bw/day (Wistar rats, local effects, OECD 422, gavage) - inhalation: LOAEC = 5 ppm corresponding to approx. 0.027 mg/L (Sprague-Dawley rats, local effects, no guideline, 28 days, vapour) - inhalation: NOAEC = 5 ppm corresponding to approx. 0.027 mg/L (Swiss-Webster mice, local effects, no guideline, 28 days, vapour) - inhalation: LOAEC = 5 ppm corresponding to approx. 0.027 mg/L (New Zealand White rabbits, local effects, no guideline, 28 days, vapour) - inhalation: LOAEC = 5 ppm corresponding to approx. 0.027 mg/L (Beagle dogs, local effects, no guideline, 28 days, vapour) - dermal: no data Data from the structural analogue n-butyl acrylate (CAS No. 141-32-2): - oral: NOAEL = 84 mg/kg bw/day for males (DowChemicalCo, rats, OECD 408, 13 weeks, drinking water) - oral: NOAEL = 111 mg/kg bw/day for females (DowChemicalCo, rats, OECD 408, 13 weeks, drinking water) - inhalation: NOAEC = 108 ppm (BASF, Sprague-Dawley rats, local effects, OECD 413, 13 weeks, vapour) - inhalation: LOAEC = 211 ppm (BASF, Sprague-Dawley rats, local effects, OECD 413, 13 weeks, vapour) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43cce6ca-726b-4763-9b5b-b388d56ed3cf/documents/IUC5-a0038c5b-faa0-44e8-8815-d74627e9edcf_fd98083d-597d-4947-9ae2-be345ead3374.html,,,,,, 4-hydroxybutyl acrylate,2478-10-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43cce6ca-726b-4763-9b5b-b388d56ed3cf/documents/IUC5-a0038c5b-faa0-44e8-8815-d74627e9edcf_fd98083d-597d-4947-9ae2-be345ead3374.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat 4-hydroxybutyl acrylate,2478-10-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43cce6ca-726b-4763-9b5b-b388d56ed3cf/documents/IUC5-a0038c5b-faa0-44e8-8815-d74627e9edcf_fd98083d-597d-4947-9ae2-be345ead3374.html,Chronic toxicity – systemic effects,inhalation,NOAEC,2.4 mg/m3,,rat 4-hydroxybutyl acrylate,2478-10-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43cce6ca-726b-4763-9b5b-b388d56ed3cf/documents/IUC5-a0038c5b-faa0-44e8-8815-d74627e9edcf_fd98083d-597d-4947-9ae2-be345ead3374.html,Repeated dose toxicity – local effects,inhalation,LOAEC,24 mg/m3,adverse effect observed,rat 4-hydroxybutyl acrylate,2478-10-6, Oral exposure route:  In a study the acute oral toxicity (LD50) of test substance in rats was determined to be 823 mg/kg bw. Inhalation exposure route: In a further study the the acute toxicity for the inhalation exposure route of test substance in rats was investigated. The LC0 was determined to be approx. 0.17 mg/L (nominal). The inhalation of a highly saturated vapour-air-mixture represents an unlikely acute hazard. Dermal exposure route: The acute dermal toxicity (LD50) of test substance in rats was determined to be > 2000 mg/kg bw in male and female rats. After a single skin contact the substance was considered to be virtually nontoxic. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43cce6ca-726b-4763-9b5b-b388d56ed3cf/documents/IUC5-e7147d9f-9ede-4ef5-8870-5eebbe5c6155_fd98083d-597d-4947-9ae2-be345ead3374.html,,,,,, 4-hydroxybutyl acrylate,2478-10-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43cce6ca-726b-4763-9b5b-b388d56ed3cf/documents/IUC5-e7147d9f-9ede-4ef5-8870-5eebbe5c6155_fd98083d-597d-4947-9ae2-be345ead3374.html,,oral,LD50,823 mg/kg bw,adverse effect observed, 4-hydroxybutyl acrylate,2478-10-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43cce6ca-726b-4763-9b5b-b388d56ed3cf/documents/IUC5-e7147d9f-9ede-4ef5-8870-5eebbe5c6155_fd98083d-597d-4947-9ae2-be345ead3374.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 4-hydroxybutyl acrylate,2478-10-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43cce6ca-726b-4763-9b5b-b388d56ed3cf/documents/IUC5-e7147d9f-9ede-4ef5-8870-5eebbe5c6155_fd98083d-597d-4947-9ae2-be345ead3374.html,,inhalation,discriminating conc.,170 mg/m3,no adverse effect observed, 4-[(3-hydroxypropyl)amino]-3-nitrophenol,92952-81-3,Substance not classified. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49213bbe-bc64-474e-9345-9f0066011097/documents/IUC5-5dfcb377-44d5-4488-b21a-698898953551_d8a512ac-ba79-49c7-a3e3-d7c6ae0e40c8.html,,,,,, 4-methyl-4-phenylpentan-2-one,7403-42-1," Oral (OECD 401), rat: LD50: > 2000 mg/kg bw (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9705fd5d-3363-498e-a4b8-a234ec45acc3/documents/a8da6a87-058a-4f52-adf4-1bc67f8f4bfc_f96595c4-ec87-46e2-b6e9-39fef3f8b06e.html,,,,,, p-tolualdehyde,104-87-0, Acute oral toxicity: The LD50 value was determined to be 1000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/764792e6-6596-48fc-a975-a58cf7302347/documents/11867d33-83a1-4550-8f53-3aeee91be453_237e613f-b5a4-4a00-a305-a9931aed4369.html,,,,,, p-tolualdehyde,104-87-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/764792e6-6596-48fc-a975-a58cf7302347/documents/11867d33-83a1-4550-8f53-3aeee91be453_237e613f-b5a4-4a00-a305-a9931aed4369.html,,oral,LD50,"1,000 mg/kg bw",, 4-methylpent-3-en-2-one,141-79-7,"In a combined repeated dose and reproductive/developmental toxicity study by inhalation in rats (OECD 422), a lowest-observed-adverse-effect concentration (LOAEC) for toxicity was determined to be 31 ppm based on effects on feed consumption, body weights, body weight gain, and nasal passage histopathology. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb0c5513-adb3-417b-9589-89b72f7e5ac6/documents/IUC5-63d44047-b0ea-4e3b-8cf3-11445ca7e64d_aef79439-cd39-4bcf-96af-e027fc07e517.html,,,,,, 4-methylpent-3-en-2-one,141-79-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb0c5513-adb3-417b-9589-89b72f7e5ac6/documents/IUC5-63d44047-b0ea-4e3b-8cf3-11445ca7e64d_aef79439-cd39-4bcf-96af-e027fc07e517.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,124 mg/m3,,rat 4-methylpent-3-en-2-one,141-79-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb0c5513-adb3-417b-9589-89b72f7e5ac6/documents/IUC5-63d44047-b0ea-4e3b-8cf3-11445ca7e64d_aef79439-cd39-4bcf-96af-e027fc07e517.html,Repeated dose toxicity – local effects,inhalation,LOAEC,124 mg/m3,adverse effect observed,rat 4-methylpent-3-en-2-one,141-79-7,The acute oral LD50 of Mesityl oxide was greater than 300 but less than 2000 mg/kg body weight (OECD 423). A weight of evidence approach based on pre-guideline studies identified a 4-hr LC50 of 1130 ppm (4530 mg/m3) in rats. The acute dermal LD50 was reported to be 5150 mg/kg for the rabbit. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb0c5513-adb3-417b-9589-89b72f7e5ac6/documents/IUC5-24b7fe9d-b1db-4ae9-b2cb-91f0e1e8053c_aef79439-cd39-4bcf-96af-e027fc07e517.html,,,,,, 4-methylpent-3-en-2-one,141-79-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb0c5513-adb3-417b-9589-89b72f7e5ac6/documents/IUC5-24b7fe9d-b1db-4ae9-b2cb-91f0e1e8053c_aef79439-cd39-4bcf-96af-e027fc07e517.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, 4-methylpent-3-en-2-one,141-79-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb0c5513-adb3-417b-9589-89b72f7e5ac6/documents/IUC5-24b7fe9d-b1db-4ae9-b2cb-91f0e1e8053c_aef79439-cd39-4bcf-96af-e027fc07e517.html,,dermal,LD50,"5,150 mg/kg bw",adverse effect observed, 4-methylpent-3-en-2-one,141-79-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb0c5513-adb3-417b-9589-89b72f7e5ac6/documents/IUC5-24b7fe9d-b1db-4ae9-b2cb-91f0e1e8053c_aef79439-cd39-4bcf-96af-e027fc07e517.html,,inhalation,LC50,"4,530 mg/m3",adverse effect observed, 4-methylpentan-2-ol,108-11-2,"Repeated dose studies with MIBC and its primary metabolites, MIBK and HMP, indicated that systemic toxicity is minimal. The NOAEC for subchronic inhalation exposure was 886 ppm (3700 mg/m3) for MIBC (6-weeks with rats) and 450 ppm (1840 mg/m3) for MIBK (2-year with rats). The NOAEL for the ultimate metabolite, HMP, via gavage dosing for 45 days was 30 mg/kg/day for males (based on hyaline droplet nephropathy) and 100 mg/kg/day for females. There were no organ-specific toxic effects for either chemical relevant for human risk assessment. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2ffc815-6bd2-4d36-8092-6903954a718c/documents/IUC5-38c7407d-372e-4798-a286-bc4f602ab098_7a083db0-ad15-4b21-89c4-7a94816e4f75.html,,,,,, 4-methylpentan-2-ol,108-11-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2ffc815-6bd2-4d36-8092-6903954a718c/documents/IUC5-38c7407d-372e-4798-a286-bc4f602ab098_7a083db0-ad15-4b21-89c4-7a94816e4f75.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"3,698 mg/m3",,rat 4-methylpentan-2-ol,108-11-2,"Studies with experimental animals indicate that MIBC is of low toxicity by the oral, dermal and inhalation routes of exposure. MIBC has typical organic solvent effects in rats following acute inhalation exposures with anesthetic effects occurring at 10 mg/L (2360 ppm). The 4-h LC50 was greater than 16000 mg/m3 in rats. The acute oral and dermal LD50 values for MIBC are 2590 mg/kg in rats and 2870 mg/kg in rabbits, respectively. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2ffc815-6bd2-4d36-8092-6903954a718c/documents/IUC5-08b3d3aa-c336-436b-b81c-97e3e8c9ffa1_7a083db0-ad15-4b21-89c4-7a94816e4f75.html,,,,,, 4-methylpentan-2-ol,108-11-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2ffc815-6bd2-4d36-8092-6903954a718c/documents/IUC5-08b3d3aa-c336-436b-b81c-97e3e8c9ffa1_7a083db0-ad15-4b21-89c4-7a94816e4f75.html,,oral,LD50,"2,590 mg/kg bw",, 4-methylpentan-2-ol,108-11-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2ffc815-6bd2-4d36-8092-6903954a718c/documents/IUC5-08b3d3aa-c336-436b-b81c-97e3e8c9ffa1_7a083db0-ad15-4b21-89c4-7a94816e4f75.html,,dermal,LD50,"2,870 mg/kg bw",, 4-methylpentan-2-ol,108-11-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2ffc815-6bd2-4d36-8092-6903954a718c/documents/IUC5-08b3d3aa-c336-436b-b81c-97e3e8c9ffa1_7a083db0-ad15-4b21-89c4-7a94816e4f75.html,,inhalation,discriminating conc.,"16,000 mg/m3",, 4-nitro-m-phenylenediamine,5131-58-8," LD50 was considered to be 1650 mg/kg (1380-1800) when SPF Wistar female rats were treated with 4-nitrobenzene-1,3-diamine orally by gavage. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6db00f90-a4b7-4449-924c-7cda21bddd34/documents/b9c3444b-8d3a-4e1f-a09a-1fa4b2596388_c0c74d80-3011-4d4e-b2f1-c08e875a5362.html,,,,,, 4-nitro-m-phenylenediamine,5131-58-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6db00f90-a4b7-4449-924c-7cda21bddd34/documents/b9c3444b-8d3a-4e1f-a09a-1fa4b2596388_c0c74d80-3011-4d4e-b2f1-c08e875a5362.html,,oral,LD50,"1,650 mg/kg bw",adverse effect observed, 4-tert-butylbenzaldehyde,939-97-9,"Acute Oral Toxicity, rat: LD50 = 50.6 mg/kg bw (BASF79/168)Acute dermal toxicity, Rabbit: LD 50 > 2000 mg/kg bw (BASF79/168) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57fab96c-5e8b-48d9-b22c-9978fa562344/documents/IUC5-33ec7d52-db18-4c81-8dfd-96b0e88aa8d8_e67da83a-add0-4d72-98b0-15544b808572.html,,,,,, 4-tert-butylcyclohexanol,98-52-2,"28 days, subacute, oral, rat (OECD 407): NOAEL = 150 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f221f40-2ad4-4fa7-9874-5d781da6bd4c/documents/db7d11e3-8c20-497d-a0de-d1fd3344729f_27e770a9-ab3a-4faf-9546-a79b5081abd8.html,,,,,, 4-tert-butylcyclohexanol,98-52-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f221f40-2ad4-4fa7-9874-5d781da6bd4c/documents/db7d11e3-8c20-497d-a0de-d1fd3344729f_27e770a9-ab3a-4faf-9546-a79b5081abd8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat 4-tert-butylcyclohexanol,98-52-2,"Oral (similar to OECD 401), rat: LD50 = 4200 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f221f40-2ad4-4fa7-9874-5d781da6bd4c/documents/f44d563c-abcf-4cac-b7c5-fe62e067152e_27e770a9-ab3a-4faf-9546-a79b5081abd8.html,,,,,, p-menth-1-en-4-ol,562-74-3,"Acute oral toxicity: LD50 of 1300.0 mg/kg bw (MB Research Lab, 1977)   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fccaf84-f874-444b-8aea-b4dd62263625/documents/242a278b-8865-4ef3-b593-33ffbfababfd_5c501567-a7f2-4444-b4b0-720f0719c4c8.html,,,,,, p-menth-1-en-4-ol,562-74-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fccaf84-f874-444b-8aea-b4dd62263625/documents/242a278b-8865-4ef3-b593-33ffbfababfd_5c501567-a7f2-4444-b4b0-720f0719c4c8.html,,oral,LD50,"1,300 mg/kg bw",adverse effect observed, 4-tert-butylcyclohexyl acetate,32210-23-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53857fa5-ea18-4ef1-b80d-a567937ed3b8/documents/3192e726-bdbd-41cd-9452-f12f8601ae2a_da33bf19-94ed-458b-9593-60150a1ed0a5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 4-tert-butylcyclohexyl acetate,32210-23-4," - Acute toxicity: oral (rats; combined): LD50 = 3370 mg/kg bw (similar to OECD 401, K, rel.2). - Acute toxicity: inhalation: Waiver. - Acute toxicity: dermal (rabbits, combined): LD50 > 4680 mg/kg bw (similar to OECD 402, K, rel.2) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53857fa5-ea18-4ef1-b80d-a567937ed3b8/documents/2d8a02e3-8b9d-4aff-94f0-72f3b5706be4_da33bf19-94ed-458b-9593-60150a1ed0a5.html,,,,,, 4-tert-butylcyclohexyl acetate,32210-23-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53857fa5-ea18-4ef1-b80d-a567937ed3b8/documents/2d8a02e3-8b9d-4aff-94f0-72f3b5706be4_da33bf19-94ed-458b-9593-60150a1ed0a5.html,,oral,LD50,"3,370 mg/kg bw",no adverse effect observed, 4-tert-butylcyclohexyl acetate,32210-23-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53857fa5-ea18-4ef1-b80d-a567937ed3b8/documents/2d8a02e3-8b9d-4aff-94f0-72f3b5706be4_da33bf19-94ed-458b-9593-60150a1ed0a5.html,,dermal,LD50,"4,680 mg/kg bw",no adverse effect observed, 3-(4-tert-butylphenyl)propionaldehyde,18127-01-0," In a GLP OECD 422 study, Bourgeonal was administered via oral gavage to male and female Crl:CD(SD) Sprague Dawley rats once daily beginning before cohabitation, through mating and continuing for at least 28 days (male rats) or through parturition until Day 14 of lactation (female rats) at doses of 0.5, 1, or 5 mg/kg/dose. Administration of Bourgeonal did not produce any mortality or clinical signs in the P generation males or females at any dose. There were no Bourgeonal related effects on mating and fertility in the P generation males or females or any effects on estrous cycling and natural delivery parameters in the P generation females. There were no Bourgeonal-related differences in any preweaning developmental parameter evaluated in the F1generation offspring. Furthermore, there were no Bourgeonal-related macroscopic or microscopic findings or alterations in the organ weights in the P generation adults or F1generation pups. Based on these findings, the no-observed-adverse-effect-level (NOAEL) for general toxicity, mating, and fertility for Bourgeonal in P generation males and females was 5 mg/kg/dose. The NOAEL for development of the F1 generation offspring was also 5 mg/kg/dose. In a GLP non guideline study, rats were orally gavaged over a period of 5 days. Treatment of male rats with Bourgeonal was associated with systemic toxicity at 250 and 100 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89c4a830-0cb1-48fe-9611-d0bede299668/documents/IUC5-918a5a38-57c2-4ced-b75b-cdd11a888c10_6d445cfa-87f6-447e-be09-dd47e9c631d1.html,,,,,, 3-(4-tert-butylphenyl)propionaldehyde,18127-01-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89c4a830-0cb1-48fe-9611-d0bede299668/documents/IUC5-918a5a38-57c2-4ced-b75b-cdd11a888c10_6d445cfa-87f6-447e-be09-dd47e9c631d1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat 3-(4-tert-butylphenyl)propionaldehyde,18127-01-0,"The test substance was assessed for acute oral toxicity in rats using a single dose administered by oral gavage. The LD50 was calculated to be 2.66 mL/kg bw with 95% confidence limits of 2.43 and 2.9 mL/kg bw.The test substance was assessed for acute dermal toxicity in New Zealand white rabbits. There were no treatment-related deaths therefore the LD50 was > 5000 mg/kg.Supporting information was available on the analogue substance Florhydral. An acute dermal toxicity study was performed on rats using a fixed dose procedure. The LD50 was > 5000 mg/kg for Florhydral. A further acute dermal study was performed on rabbits also using a fixed dose procedure. In this study on the analogue substance, Florhydral, the LD50 was > 5000 mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89c4a830-0cb1-48fe-9611-d0bede299668/documents/IUC5-00ba0214-4789-4c53-8e05-df1df698e9c2_6d445cfa-87f6-447e-be09-dd47e9c631d1.html,,,,,, 3-(4-tert-butylphenyl)propionaldehyde,18127-01-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89c4a830-0cb1-48fe-9611-d0bede299668/documents/IUC5-00ba0214-4789-4c53-8e05-df1df698e9c2_6d445cfa-87f6-447e-be09-dd47e9c631d1.html,,oral,LD50,"2,550 mg/kg bw",adverse effect observed, 3-(4-tert-butylphenyl)propionaldehyde,18127-01-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89c4a830-0cb1-48fe-9611-d0bede299668/documents/IUC5-00ba0214-4789-4c53-8e05-df1df698e9c2_6d445cfa-87f6-447e-be09-dd47e9c631d1.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, 4-tert-butyltoluene,98-51-1,"ORAL 28-day study in rats (0, 1.5, 5, 15, 50 mg/kg bw/d by gavage), equivalent to OECD TG 407. (Nihon Bioresearch, Inc.,)The LOAEL is 5 mg/kg bw for males and 15 mg/kg bw for females. The NOEL is 1.5 mg/kg bw for males and 5 mg/kg bw for females. DERMAL No data are available. INHALATION 26- week study in rats (ca. 0.15 or 0.3 mg/l) (Hine et al., 1954). A NOAEL could not be established, based on adverse findings observed at both dose levels. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a96d8e92-0894-46ba-bb31-d9170c57ee61/documents/IUC5-b824611a-49a6-422a-8319-48f51870d7b1_a70b2a0d-0f96-4c93-910f-be39442fb2fb.html,,,,,, 4-tert-butyltoluene,98-51-1,"ORAL Oral LD50 (male rat): ca. 1550 mg/kg bw (original value: LD50 = 1.8 ± 0.14 ml/kg bw) (Hine et al., 1954) DERMAL Dermal LD50 (rabbit): ca. 16880 mg/kg bw (95% C.I. ca. 11880 – 23940) (Hine et al., 1954) (Original value: Dermal LD50 = 19.6 ml/kg bw (95% C.I. 13.8 – 27.8)) INHALATION LC50 (female rat): ca. 1.5 mg/L (Original value: LC50 = 248 ± 36 ppm) (Hine et al., 1954) The substance, p-tertiary butyl toluene, causes damage to central nervous system after single application. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a96d8e92-0894-46ba-bb31-d9170c57ee61/documents/IUC5-8b492094-e506-44ce-8ef8-80c0b650b1d9_a70b2a0d-0f96-4c93-910f-be39442fb2fb.html,,,,,, "3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol",3407-42-9,"Repeated dose toxicity: Oral OECD 408 (GLP) (Key Study No. 1):  NOAEL was considered to be 300 mg/kg bw/day as no adverse effects were observed at this dose level in either male or female rats. LOAEL was considered to be 1000 mg/kg bw/day based on significant changes in clinical chemistry, organ weight, and histopathological findings (liver lesions) in both male and female rats.  OECD 407 (GLP) (Key Study No. 2): The No-Observed-Effect-Level (NOEL) in both genders was considered to be 125 mg/kg bw/day. The Lowest-Observed-Effect-Level (LOEL) was considered to be 375 mg/kg bw/day in both genders based on significant changes in clinical chemistry, hematology (females only) and organ weight (liver; females only). Few of the significant changes in clinical chemistry could be corroborated with increased liver weight and these were considered to be due to increased metabolic demand in the liver as a result of treatment with a xenobiotic (i.e. adaptive change). The other changes in hematology (females only) and clinical chemistry could not be corroborated with any gross or histopathological lesions in the liver, kidney, or any other organ or tissue, or any clinical signs of toxicity, and these changes in hematology and clinical chemistry were therefore considered to be of unclear toxicological significance in terms of adversity. A conservative NOAEL value can be considered to be 125 mg/kg bw/day in this study, i.e. the same dose level where the NOEL value was observed. Repeated dose toxicity: Inhalation The test substance 3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol has very low vapor pressure (0.00162 Pa), so the potential for the generation of inhalable vapours of 3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol is low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and therefore this end point was considered for waiver   Repeated dose toxicty: Dermal The results for acute toxicity by the dermal route indicate the LD50 value to be greater than 2000 mg/kg body weight. In addition, the skin sensitization also indicates negative skin sensitization potential by the chemical 3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol. Also considering the use of the chemical as a fragrance chemical and considering the low volatility absorption by the dermal route is not likely to be significant. Thus, given the above considerations, it is assumed that 3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol shall not exhibit repeated dose toxicity by the dermal route. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a32997e4-980d-4568-ac1e-f3481c1f44a7/documents/25852b5a-cc69-4fde-9953-871470df3dbd_45145405-dc34-4af2-aa20-3d9e14265be0.html,,,,,, "3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol",3407-42-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a32997e4-980d-4568-ac1e-f3481c1f44a7/documents/25852b5a-cc69-4fde-9953-871470df3dbd_45145405-dc34-4af2-aa20-3d9e14265be0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol",3407-42-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a32997e4-980d-4568-ac1e-f3481c1f44a7/documents/25852b5a-cc69-4fde-9953-871470df3dbd_45145405-dc34-4af2-aa20-3d9e14265be0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol",3407-42-9,"Acute oral toxicity:    The acute oral toxicity dose (LD50) for test chemical was considered based on experimental study, the value considered to be >2000 mg/kg bw in rats. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute oral toxicity.   Acute Inhalation toxicity: For test chemical, acute toxicity testing by the inhalation route was considered for waiver given that the substance has low vapour pressure of 0.00162 Pa at 25 degree C . Thus, exposure by inhalation is also unlikely for test chemical given the comparitively larger size of the particulates.   Acute Dermal toxicity:   The acute dermal toxicity dose (LD50) for test chemical was considered based on experimental study, the value considered to be >2000 mg/kg bw in rabbits. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a32997e4-980d-4568-ac1e-f3481c1f44a7/documents/39c24121-81e4-4ada-b99d-4c5901b93c4d_45145405-dc34-4af2-aa20-3d9e14265be0.html,,,,,, "3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol",3407-42-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a32997e4-980d-4568-ac1e-f3481c1f44a7/documents/39c24121-81e4-4ada-b99d-4c5901b93c4d_45145405-dc34-4af2-aa20-3d9e14265be0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol",3407-42-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a32997e4-980d-4568-ac1e-f3481c1f44a7/documents/39c24121-81e4-4ada-b99d-4c5901b93c4d_45145405-dc34-4af2-aa20-3d9e14265be0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "5-bromo-5-nitro-1,3-dioxane",30007-47-7," Male and female Han Wistar rats were exposed to the test substance for 5 days per week for 14 weeks in a non-GLP study, comparable to OECD Guideline 408. Based upon the following effect observed in animals initially dosed with 100 mg/kg bw/day and subsequently increased to 200 mg/kg bw/day in week 7:  Mucosal necrosis and purulent mucosal inflammation in the cutaneous stomach, single cell necroses and slightly increased single-cell fatty degeneration in the liver, increased hypoxic changes in the heart, progressive transformation of the adrenal cortex and activation of the lymph nodes, the NOAEL for this substance in Han Wistar rats has be determined to be 50 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b89803eb-0cea-425b-9a11-d04d64a0f8d5/documents/504f713b-e4c0-495a-bf53-dae06928b9e4_0b1ecb76-fd01-402d-951b-633240f6985a.html,,,,,, "5-bromo-5-nitro-1,3-dioxane",30007-47-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b89803eb-0cea-425b-9a11-d04d64a0f8d5/documents/504f713b-e4c0-495a-bf53-dae06928b9e4_0b1ecb76-fd01-402d-951b-633240f6985a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "5-bromo-5-nitro-1,3-dioxane",30007-47-7," Acute oral toxicity testing has been conducted in two studies in rodents. The key study, equivalent to the OECD 401 guideline, was conducted in male Wistar rats and derived an LD50 value of 455 mg/kg bw based upon 9 tested doses between 100 and 754 mg/kg bw delivered in olive oil by oral gavage. A supporting study conducted in mice (non-GLP, non-guideline) determined the LD50 to be 590 mg/kg bw; no details on doses, number or sex of animals is available. Testing by the inhalation and dermal routes was waived for animal welfare reasons based upon the dermal corrosivity of the test substance. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b89803eb-0cea-425b-9a11-d04d64a0f8d5/documents/df3b816a-e56f-4d72-94ce-70534085b994_0b1ecb76-fd01-402d-951b-633240f6985a.html,,,,,, "5-bromo-5-nitro-1,3-dioxane",30007-47-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b89803eb-0cea-425b-9a11-d04d64a0f8d5/documents/df3b816a-e56f-4d72-94ce-70534085b994_0b1ecb76-fd01-402d-951b-633240f6985a.html,,oral,LD50,455 mg/kg bw,adverse effect observed, "Octahydro-4,7-methano-1H-inden-5-yl acetate",64001-15-6," The Acute oral toxicity of Cyclacet Dihydro, using read across from Cyclacet: 2750 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8432b55-1dd2-423e-86ec-348983e872fe/documents/4437d2e8-5dfe-4b3a-8231-dd30d00389fd_cd44a465-ff82-4ef2-b19a-b62e9563720f.html,,,,,, 5-methyl-5-phenylhexan-3-one,4927-36-0,Acute oral toxicity using read across from Vetikon (OECD TG 401): LD50 >2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/485924c5-d0cd-4c82-9a55-4d31b40fb5f6/documents/IUC5-887d21e5-ceb5-411a-9f73-2307ee1b289f_760d0a61-19b3-49d8-892f-d10e2ab66027.html,,,,,, Aminocaproic acid,60-32-2," In an acute oral toxicity study in mouse, a LD50 of 14300 mg/kg bw was determined (reference 7.2.1 -1). In an acute oral toxicity study in dog, a LD50 of above 7000 mg/kg bw was determined (reference 7.2.1 -2). In an acute oral toxicity study in monkey, a LD50 of above 7000 mg/kg bw was determined (reference 7.2.1 -3). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a4eb466-b0db-42f5-9255-766f51133891/documents/756e52ea-ad12-4de5-9673-e49199153a71_2469aba4-83cc-4878-9af4-32e2d51e9a06.html,,,,,, Aminocaproic acid,60-32-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a4eb466-b0db-42f5-9255-766f51133891/documents/756e52ea-ad12-4de5-9673-e49199153a71_2469aba4-83cc-4878-9af4-32e2d51e9a06.html,,oral,discriminating dose,"7,000 mg/kg bw",no adverse effect observed, 6-methylhept-5-en-2-one,110-93-0, Repeated dose toxicity (OECD TG 408): NOAEL = 200 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5dc787d-3805-4525-a58d-7d65710343a0/documents/b9f554c6-15b0-4671-b303-0ed5398a623d_2d1cc10e-934b-4703-8482-5f232185600d.html,,,,,, 6-methylhept-5-en-2-one,110-93-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5dc787d-3805-4525-a58d-7d65710343a0/documents/b9f554c6-15b0-4671-b303-0ed5398a623d_2d1cc10e-934b-4703-8482-5f232185600d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat 6-methylhept-5-en-2-one,110-93-0, Acute oral toxicity (similar to OECD TG 401): LD50 = 3570 mg/kg bw Acute dermal toxicity (non-guideline study): LD50 >5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5dc787d-3805-4525-a58d-7d65710343a0/documents/620b98b5-fbdb-4b9d-b69e-52074c1c18c3_2d1cc10e-934b-4703-8482-5f232185600d.html,,,,,, 6-methylhept-5-en-2-one,110-93-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5dc787d-3805-4525-a58d-7d65710343a0/documents/620b98b5-fbdb-4b9d-b69e-52074c1c18c3_2d1cc10e-934b-4703-8482-5f232185600d.html,,oral,LD50,"3,570 mg/kg bw",adverse effect observed, 6-methylhept-5-en-2-one,110-93-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5dc787d-3805-4525-a58d-7d65710343a0/documents/620b98b5-fbdb-4b9d-b69e-52074c1c18c3_2d1cc10e-934b-4703-8482-5f232185600d.html,,dermal,LD50,"5,000 mg/kg bw",adverse effect observed, 6-sec-butylquinoline,65442-31-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/faeb1ffa-0467-4ea7-a5ed-08bdabc04820/documents/10af1f57-518d-420e-ade7-616245bcffb5_ca47e4ce-8739-4598-8cc8-dc2ab6de2866.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole",7747-35-5,"The repeat dose toxicity of the substance were examined in 28-day and 90-day repeat dose oral studies in the dog and the rat. The 4-week oral study in rats was associated with gastrointestinal (portal of entry) effects, and systemic effects were attributed to chronic active inflammation and ulceration of the stomach. The 4-week oral study in dogs found vomiting to be the dose-limiting effect, with no other signs of systemic toxicity. Subsequent subchronic (90-day) studies in both rats and dogs supported these findings, and in the 90 day dog study a NOEL and NOAEL for systemic effects could not be established because of the vomiting that occurred in some dogs at all dose levels. Other toxicological findings were interpreted to be either secondary to the effects already noted or of limited toxicological significance. The NOAEL for systemic toxicity in rats was 50 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acc3793f-36cf-43d2-8034-f3aba8abaf0b/documents/IUC5-8232d73d-92a7-4c24-80d3-42405b818077_bbcbcf24-1c97-4680-9abb-2a28d10be71d.html,,,,,, "7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole",7747-35-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acc3793f-36cf-43d2-8034-f3aba8abaf0b/documents/IUC5-8232d73d-92a7-4c24-80d3-42405b818077_bbcbcf24-1c97-4680-9abb-2a28d10be71d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole",7747-35-5,"The acute oral toxicity of CS-1246 is low with LD50 levels in male and female rats at 5249 mg/kg (4503-6673 mg/kg), and 3674 mg/kg (3216-4197 mg/kg) respectively. The acute dermal toxicity in the rat is therefore greater than 2,000 mg/kg. In an acute dermal toxicity study in the rabbit with abraded skin the dermal LD50 was 1948 mg/kg (1596-18495 mg/kg). The acute dermal study in rat is considered to be the key study for this enpoint as it meets current protocol guidelines and is conducted to GLP.The acute inhalation LC50 was calculated to be 3.1 mg/L (95% CI, 2.7-3.5 mg/L) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acc3793f-36cf-43d2-8034-f3aba8abaf0b/documents/IUC5-e435bb72-0492-47f4-a487-33d2e85d0e10_bbcbcf24-1c97-4680-9abb-2a28d10be71d.html,,,,,, "7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole",7747-35-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acc3793f-36cf-43d2-8034-f3aba8abaf0b/documents/IUC5-e435bb72-0492-47f4-a487-33d2e85d0e10_bbcbcf24-1c97-4680-9abb-2a28d10be71d.html,,oral,LD50,"3,674 mg/kg bw",, "7a-ethyldihydro-1H,3H,5H-oxazolo[3,4-c]oxazole",7747-35-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acc3793f-36cf-43d2-8034-f3aba8abaf0b/documents/IUC5-e435bb72-0492-47f4-a487-33d2e85d0e10_bbcbcf24-1c97-4680-9abb-2a28d10be71d.html,,inhalation,LC50,3.1 mg/m3,, A mixture of cis- and trans-cyclohexadec-8-en-1-one,3100-36-5,"In the key subacute feeding study in male and female Wistar rats according to OECD guideline 407, the NOAEL was 232.25 mg/kg bw/day in males and 250.75 mg/kg bw/day in females. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Reliable with restrictions (RL2) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/902a2b83-b618-4f47-8d18-a3b4ada3845a/documents/25953e99-ae67-477a-b2e6-104d066dff36_d40a2664-6273-414a-9b9b-fa4a25fbed79.html,,,,,, A mixture of cis- and trans-cyclohexadec-8-en-1-one,3100-36-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/902a2b83-b618-4f47-8d18-a3b4ada3845a/documents/25953e99-ae67-477a-b2e6-104d066dff36_d40a2664-6273-414a-9b9b-fa4a25fbed79.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,232.25 mg/kg bw/day,,rat A mixture of cis- and trans-cyclohexadec-8-en-1-one,3100-36-5,"In the key acute oral toxicity study in rats according to OECD guideline 401, the LD50 was higher than 10000 mg/kg bw.   In the key acute dermal toxicity study in rabbits according to OECD guideline 402, the LD50 was higher than 4600 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable without restrictions (RL1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Reliable with restrictions (RL2): According to OECD 402 and GLP, but individual animal results not provided in the report. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/902a2b83-b618-4f47-8d18-a3b4ada3845a/documents/2fa701b5-1e78-4459-b1d6-0f405c33d05a_d40a2664-6273-414a-9b9b-fa4a25fbed79.html,,,,,, A mixture of cis- and trans-cyclohexadec-8-en-1-one,3100-36-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/902a2b83-b618-4f47-8d18-a3b4ada3845a/documents/2fa701b5-1e78-4459-b1d6-0f405c33d05a_d40a2664-6273-414a-9b9b-fa4a25fbed79.html,,oral,discriminating dose,"> 10,000 mg/kg bw",no adverse effect observed, A mixture of cis- and trans-cyclohexadec-8-en-1-one,3100-36-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/902a2b83-b618-4f47-8d18-a3b4ada3845a/documents/2fa701b5-1e78-4459-b1d6-0f405c33d05a_d40a2664-6273-414a-9b9b-fa4a25fbed79.html,,dermal,discriminating dose,"> 4,600 mg/kg bw",no adverse effect observed, p-menth-1-en-8-yl acetate,80-26-2,A 20-week repeated dose toxicity study in rats the NOAEL was >=400 mg/kg bw/day (10000 mg/kg diet) for alpha-Terpinyl Acetate. This NOAEL is supported with information from its main metabolite: Terpineol multi. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fadd74e-f4ce-4e9d-ab0b-a53be1a4b12a/documents/IUC5-11e35ce3-f384-4f73-acc8-2182ae9c6b85_4ea77ee2-31d9-442f-9e95-e324c54f6857.html,,,,,, p-menth-1-en-8-yl acetate,80-26-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fadd74e-f4ce-4e9d-ab0b-a53be1a4b12a/documents/IUC5-11e35ce3-f384-4f73-acc8-2182ae9c6b85_4ea77ee2-31d9-442f-9e95-e324c54f6857.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat p-menth-1-en-8-yl acetate,80-26-2,A LD50 of 5075 mg/kg bw (95% CI = 4160-6190) was obtained in the acute oral toxicity study with rats. A LC50 value of 30450 mg/m3 was calculated for acute inhalation toxicity being above the saturated vapour pressure of 281 mg/m3. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fadd74e-f4ce-4e9d-ab0b-a53be1a4b12a/documents/IUC5-0ab60fbf-1ee4-47b1-9aca-c94f40835a23_4ea77ee2-31d9-442f-9e95-e324c54f6857.html,,,,,, "Fir, Abies alba, ext.",90028-76-5,"Acute toxicity, oral: LD50 > 5000 mg/kg bw (K, Rel.2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c5c8398-4b1a-45e5-bbe1-7b2cd913da37/documents/7982d8df-5663-490f-85fc-c5119319cd22_f5cec3fc-555b-44ba-b43c-cafaa13bef89.html,,,,,, "Fir, Abies alba, ext.",90028-76-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c5c8398-4b1a-45e5-bbe1-7b2cd913da37/documents/7982d8df-5663-490f-85fc-c5119319cd22_f5cec3fc-555b-44ba-b43c-cafaa13bef89.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Fir, Abies balsamea, ext.",85085-34-3," Acute oral toxicity: LD50 >2000 mg/kg bw (according to OECD TG 423, EU TM B.1tris) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37db5e89-8eb0-4476-a8ef-579e37206d00/documents/95a89925-c453-4a87-be59-ec726727285a_401d7e8a-a807-4a3c-b332-0e884a07f1cc.html,,,,,, "Fir, Abies balsamea, ext.",85085-34-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37db5e89-8eb0-4476-a8ef-579e37206d00/documents/95a89925-c453-4a87-be59-ec726727285a_401d7e8a-a807-4a3c-b332-0e884a07f1cc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fir, Abies sibirica, ext.",91697-89-1," Acute toxicity, oral: LD50 > 5000 mg/kg bw (K, Rel.2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1dc8a3b-8ad9-401f-b0ce-253f50027b69/documents/c519460e-b1ac-4064-9955-4f4d6aad1c4e_61cd79de-59bb-4855-803a-ddc5ff63668c.html,,,,,, "Fir, Abies sibirica, ext.",91697-89-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1dc8a3b-8ad9-401f-b0ce-253f50027b69/documents/c519460e-b1ac-4064-9955-4f4d6aad1c4e_61cd79de-59bb-4855-803a-ddc5ff63668c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Acetaldehyde,75-07-0,"Effects of acetaldehyde following oral administration to animals have been much less well studied than those following inhalation. In a 28-day study in which acetaldehyde was administered to rats by the oral route, the NOEL was 125 mg/kg bw per day. At the next higherconcentration 675 mg/kg bw per day, a borderline increase in hyperkeratosis of the forestomach was oserved. In rats exposed to 0.05% acetaldehyde in drinking-water for 6 months, acetaldehyde induced synthesis of rat liver collagen, an observation that was supported by in vitro data. No other effects were examined and the toxicological significance of this observation is unknown.In a repeated dose inhalation study, the lowest concentration at which effects were observed (degenerative changes in the olfactory epithelium in rats) was 437 mg/m3 following administration for 5 weeks. The NOELs identified for respiratory effects were 275 mg/m3 in rats exposed for 4 weeks and 700 mg/m3 in hamsters exposed for 13 weeks. Increased incidences of tumours have been observed in inhalation studies on rats and hamsters exposed to acetaldehyde. See thereto key information under IUCLID section 7.7: Carcinogenicity.No repeated dose dermal studies were identified. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8924968a-508e-4ce2-86e6-7b2c135dcdc9/documents/c091a50e-3621-48f7-b73e-9b7902824ef8_4f865cde-eef1-423d-9275-493aa0dd0187.html,,,,,, Acetaldehyde,75-07-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8924968a-508e-4ce2-86e6-7b2c135dcdc9/documents/c091a50e-3621-48f7-b73e-9b7902824ef8_4f865cde-eef1-423d-9275-493aa0dd0187.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Acetaldehyde,75-07-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8924968a-508e-4ce2-86e6-7b2c135dcdc9/documents/c091a50e-3621-48f7-b73e-9b7902824ef8_4f865cde-eef1-423d-9275-493aa0dd0187.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,275 mg/m3,,rat Acetaldehyde,75-07-0,"Several actue toxicity studies are available. In the acute oral toxicity studies, the LD50 in rats and mice ranged from 660 to 1930 mg/kg bw. LC50 (0.5-4 h) in rats and Syrian hamsters ranged from 24 to 37 g/m3. It is therefore concluded that the acute toxicity of acetaldehyde is low. LD50 values by the dermal route were not available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8924968a-508e-4ce2-86e6-7b2c135dcdc9/documents/192fb158-9304-444e-81e5-11ba7a24a9d1_4f865cde-eef1-423d-9275-493aa0dd0187.html,,,,,, "1,1-diethoxyethane",105-57-7," According to the available literature, the oral LD50 of the test substance is above 4000 mg/kg bw in rat (reference 7.2.1-1 to 7.2.1-3) and above 2360 mg/kg bw in rabbit (reference 7.2.1-4). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78bd9247-cfde-4f38-9749-c44bc8ef8e4e/documents/644e58f4-4d43-44da-987f-83a0e89b5b8c_0fe06c0e-cd57-4317-9b82-803368a71b41.html,,,,,, "1,1-diethoxyethane",105-57-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78bd9247-cfde-4f38-9749-c44bc8ef8e4e/documents/644e58f4-4d43-44da-987f-83a0e89b5b8c_0fe06c0e-cd57-4317-9b82-803368a71b41.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, [2-(1-propoxyethoxy)ethyl]benzene,7493-57-4, Acute oral toxicity (OECDTG401): LD50 > 5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87911581-9b74-492b-a713-035bed3c0efb/documents/b458ccbf-15d8-4a62-800e-1f330fd1baab_fbe98d95-4026-488a-b526-54a5f84070f6.html,,,,,, Acetic acid,64-19-7,"This review of acetic acid for REACh has not uncovered any information to undermine the following statement.“Long-term toxicity/carcinogenicity studies in animals with oral exposure are not necessary, considering that humans are exposed to orally ingested acetic acid from various food sources and there is no evidence that such exposure is causally related to toxic effects and an increased cancer incidence. Therefore, no new animal toxicity studies conforming to long-term toxicity or carcinogenicity test guidelines are necessary for Annex I inclusion of acetic acid.” (EU DAR, 2008). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3151b201-9c26-4917-af22-4309e9c79394/documents/IUC5-fca90b54-be01-4f4e-90a1-e77329670049_0e796632-cffa-44e1-85a2-d885f5160547.html,,,,,, Acetic acid,64-19-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3151b201-9c26-4917-af22-4309e9c79394/documents/IUC5-fca90b54-be01-4f4e-90a1-e77329670049_0e796632-cffa-44e1-85a2-d885f5160547.html,Repeated dose toxicity – local effects,dermal,NOAEL,30 ,adverse effect observed, Acetic acid,64-19-7,"There is sufficient information to conclude that acetic acid is of low acute, oral inhalation and dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3151b201-9c26-4917-af22-4309e9c79394/documents/IUC5-24d402a9-0c2b-4667-9078-ebd34226042a_0e796632-cffa-44e1-85a2-d885f5160547.html,,,,,, Acetic acid,64-19-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3151b201-9c26-4917-af22-4309e9c79394/documents/IUC5-24d402a9-0c2b-4667-9078-ebd34226042a_0e796632-cffa-44e1-85a2-d885f5160547.html,,oral,LD50,"3,310 mg/kg bw",no adverse effect observed, Acetic acid,64-19-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3151b201-9c26-4917-af22-4309e9c79394/documents/IUC5-24d402a9-0c2b-4667-9078-ebd34226042a_0e796632-cffa-44e1-85a2-d885f5160547.html,,inhalation,LC50,"40,000 mg/m3",adverse effect observed, Acetone,67-64-1,"13 week oral drinking water, rat male : LOAEL 20,000 ppm corresponding to a dose of 1,700 mg/kg bw/d (target organs: testis, kidneys, and hematopoetic system); NOAEL 10,000 ppm or 900 mg/kg bw/d rat, female: NOAEL 50,000 ppm or 3,100 mg/kg bw/d mouse, male: NOAEL 20,000 ppm or 4,858 mg/kg bw/d mouse, female: LOAEL 50,000 ppm or 11,298 mg/kg bw/d (target organ: liver) NOAEL 20,000 ppm or 5,945 mg/kg bw/d 8-week inhalation, 5 d/wk, 3 hr/d, rat: 3-hr NOAEC 19,000 ppm acetone (45,000 mg/m3), extrapolated to 6-hr NOAEC 9,500 ppm (22,500 mg/m3) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f0b75c4-a963-4ebb-96f5-2e9f1366aade/documents/IUC5-15972e44-1d9d-4de9-80b0-ba54707c2e9d_0a7ae69f-7622-499b-af53-daa371e88085.html,,,,,, Acetone,67-64-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f0b75c4-a963-4ebb-96f5-2e9f1366aade/documents/IUC5-15972e44-1d9d-4de9-80b0-ba54707c2e9d_0a7ae69f-7622-499b-af53-daa371e88085.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,900 mg/kg bw/day,, Acetone,67-64-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f0b75c4-a963-4ebb-96f5-2e9f1366aade/documents/IUC5-15972e44-1d9d-4de9-80b0-ba54707c2e9d_0a7ae69f-7622-499b-af53-daa371e88085.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"22,500 mg/m3",, Acetone,67-64-1,"LD50 oral: rat 5800 mg/kgLD50 dermal: guinea pig, rabbit at least 7400 mg/kgLC50 inhalation: rat 3 hr 132000 mg/m3; rat 4 hr 76000 mg/m3 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f0b75c4-a963-4ebb-96f5-2e9f1366aade/documents/IUC5-3e73e28c-a73d-4ecb-b5f5-5335615b2ef0_0a7ae69f-7622-499b-af53-daa371e88085.html,,,,,, Acetone,67-64-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f0b75c4-a963-4ebb-96f5-2e9f1366aade/documents/IUC5-3e73e28c-a73d-4ecb-b5f5-5335615b2ef0_0a7ae69f-7622-499b-af53-daa371e88085.html,,oral,LD50,"5,800 mg/kg bw",, Acetone,67-64-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f0b75c4-a963-4ebb-96f5-2e9f1366aade/documents/IUC5-3e73e28c-a73d-4ecb-b5f5-5335615b2ef0_0a7ae69f-7622-499b-af53-daa371e88085.html,,dermal,LD50,"7,400 mg/kg bw",, Acetone,67-64-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f0b75c4-a963-4ebb-96f5-2e9f1366aade/documents/IUC5-3e73e28c-a73d-4ecb-b5f5-5335615b2ef0_0a7ae69f-7622-499b-af53-daa371e88085.html,,inhalation,LC50,"76,000 mg/m3",, Acetophenone,98-86-2,"In a 90-day repeated dose toxicity study in rat by gavage (OECD TG 408, GLP), a NOAEL was established at 250 mg/kg bw/d based on reduced body weight gain, reduced spontaneous activity and increased % reticulocytes. In an Extended One-Generation Reproductive Toxicity Study (OECD TG 443, GLP, see IUCLID section 7.8.1), the NOAELs for systemic toxicity (excluding reproductive and developmental toxicity endpoints) were considered to be:• 75 mg/kg/day in males based on adverse clinical signs from 225 mg/kg onwards,• lower than 75 mg/kg/day in females based on difficulties to deliver from this dose level. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): good quality (OECD study, GLP) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22e5e8e6-99f1-487f-873f-304702ee6b3b/documents/ae9b2be2-2090-44ac-b91e-d69d57e71346_bd44e197-9739-4b12-97ca-0fd580c1a135.html,,,,,, Acetophenone,98-86-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22e5e8e6-99f1-487f-873f-304702ee6b3b/documents/ae9b2be2-2090-44ac-b91e-d69d57e71346_bd44e197-9739-4b12-97ca-0fd580c1a135.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat Acetophenone,98-86-2,"oral LD50 rat: 2,081 mg/kg bw (key study: Worstmann, 1981)dermal LD50 rat: 3,300 mg/kg bw (key study: Marzin, 1978) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22e5e8e6-99f1-487f-873f-304702ee6b3b/documents/ad999d52-f730-4328-a6e4-5e9be0723f00_bd44e197-9739-4b12-97ca-0fd580c1a135.html,,,,,, Acetophenone,98-86-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22e5e8e6-99f1-487f-873f-304702ee6b3b/documents/ad999d52-f730-4328-a6e4-5e9be0723f00_bd44e197-9739-4b12-97ca-0fd580c1a135.html,,oral,LD50,"2,081 mg/kg bw",adverse effect observed, Acetophenone,98-86-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22e5e8e6-99f1-487f-873f-304702ee6b3b/documents/ad999d52-f730-4328-a6e4-5e9be0723f00_bd44e197-9739-4b12-97ca-0fd580c1a135.html,,dermal,LD50,"3,300 mg/kg bw",adverse effect observed, Acetylcysteine,616-91-1," According to the available literature, the oral LD50 of the test substance is above 3000 mg/kg bw in mouse and above 5050 mg/kg bw in rat (reference 7.2.1 -1 to 7.2.1 -6). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c92c0675-47c4-482b-bebc-f175e5c79524/documents/e3dd20f7-957a-4609-9efd-7f83c2d26db8_8ee5cfa8-0fdd-41ad-aa1d-230d7175e370.html,,,,,, Acetylcysteine,616-91-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c92c0675-47c4-482b-bebc-f175e5c79524/documents/e3dd20f7-957a-4609-9efd-7f83c2d26db8_8ee5cfa8-0fdd-41ad-aa1d-230d7175e370.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 3-[(2-acetamidoacetyl)amino]propanoic acid,1016788-34-3," The substance is only used as active ingredient for cosmetic products. The acute toxicity endpoint (oral route) has been assessed using a weight of evidence approach, avoiding the use of animals for in vivo tests. -In vitro acute toxicity test:: 3T3 NRU cytotoxicity assay oaccording to the OECD guidance document nº 129, the ECVAM OB-ALM nº139 protocol and the EURL ECVAM Recommendation, April 2013. Under the retained experimental conditions, the mean LD50 of the test item is equal to 3229 mg/kg, which is higher than 2000 mg/kg. The test item  N-acetylglycyl beta-alanine may be not classified for acute toxicity according to the CLP classification. -In vitro 3T3 NRU PhototoxicityTest according to the OECD guideline Nº432. The substance was found to be not phototoxic. -Predictive Acute Toxicity Assessment with the MultiCASE (CASE Ultra version 1.6.0.3). -Read-across approach from analogues (breakdown products) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8664d17-6d67-4209-b5dd-5885efb9894f/documents/c26559a2-4321-405f-bba6-c47e1cc6457a_7e8b8f8f-1793-49ba-94a0-ad8ffd2611aa.html,,,,,, "1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone",15323-35-0, The oral 28-day NOAEL is 5 mg/kg bw. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12026651-dc12-4562-96e0-f80e143ad4bf/documents/7e9f8f12-b087-42d9-8603-94707db846bf_590d8e99-be00-47d4-8c00-6159efab6a9a.html,,,,,, "1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone",15323-35-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12026651-dc12-4562-96e0-f80e143ad4bf/documents/7e9f8f12-b087-42d9-8603-94707db846bf_590d8e99-be00-47d4-8c00-6159efab6a9a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat "1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone",15323-35-0, The acute oral LD50 is 797 mg/kg bw The acute dermal LD50 is >10000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12026651-dc12-4562-96e0-f80e143ad4bf/documents/8b988bb7-0cd5-4870-a774-f1ec9ebe284c_590d8e99-be00-47d4-8c00-6159efab6a9a.html,,,,,, "1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone",15323-35-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12026651-dc12-4562-96e0-f80e143ad4bf/documents/8b988bb7-0cd5-4870-a774-f1ec9ebe284c_590d8e99-be00-47d4-8c00-6159efab6a9a.html,,oral,LD50,797 mg/kg bw,adverse effect observed, "1,1,2,3,3,6-hexamethylindan-5-yl methyl ketone",15323-35-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12026651-dc12-4562-96e0-f80e143ad4bf/documents/8b988bb7-0cd5-4870-a774-f1ec9ebe284c_590d8e99-be00-47d4-8c00-6159efab6a9a.html,,dermal,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one",1506-02-1,"- Oral: sub-chronic 90 days, NOAEL 5 mg/kg bw/day, rat, OECD 408, GLP, Lambert 1996 - Overall, the effects seen in the 13-week oral study with AHTN do not warrant classification - Subchronic (14-week) dermal toxicity study with Traseolide in rats: Although the authors did not report a NOAEL and concluded that the NOEL is 1mg/kg bw/d, a NOAEL can be derived from evaluating the raw data when taking the deficiencies of the studies into account. This NOAEL could be set to ≥10mg/kg bw/d.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35db1dfe-c83f-4040-939b-b9561003df88/documents/eeb2451e-2989-457c-8422-520734b19234_4604e8d7-a478-4556-b552-052e6e02ddf0.html,,,,,, "1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one",1506-02-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35db1dfe-c83f-4040-939b-b9561003df88/documents/eeb2451e-2989-457c-8422-520734b19234_4604e8d7-a478-4556-b552-052e6e02ddf0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,, "1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one",1506-02-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35db1dfe-c83f-4040-939b-b9561003df88/documents/eeb2451e-2989-457c-8422-520734b19234_4604e8d7-a478-4556-b552-052e6e02ddf0.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 ,, "1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one",1506-02-1," The dermal and oral toxicity of AHTN are determined by a number of studies. Based on the lowest reliable LD50 for AHTN, the classification of category 4 of the acute oral toxicity applies (Harmful if swallowed). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35db1dfe-c83f-4040-939b-b9561003df88/documents/be89bc6f-7206-4d57-a5c8-fede1bf3860e_4604e8d7-a478-4556-b552-052e6e02ddf0.html,,,,,, "1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one",1506-02-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35db1dfe-c83f-4040-939b-b9561003df88/documents/be89bc6f-7206-4d57-a5c8-fede1bf3860e_4604e8d7-a478-4556-b552-052e6e02ddf0.html,,oral,LD50,920 mg/kg bw,adverse effect observed, "1-(5,6,7,8-tetrahydro-3,5,5,6,8,8-hexamethyl-2-naphthyl)ethan-1-one",1506-02-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35db1dfe-c83f-4040-939b-b9561003df88/documents/be89bc6f-7206-4d57-a5c8-fede1bf3860e_4604e8d7-a478-4556-b552-052e6e02ddf0.html,,dermal,LD50,"7,940 mg/kg bw",adverse effect observed, Oxaceprol,33996-33-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): K1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/328891ae-10fd-45d7-95ac-e2dbd8f36d71/documents/f2ca3e7b-f941-478b-be79-13820e61d018_41609dd1-e7df-46ba-8d3d-0e92a26d70a6.html,,,,,, Oxaceprol,33996-33-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/328891ae-10fd-45d7-95ac-e2dbd8f36d71/documents/f2ca3e7b-f941-478b-be79-13820e61d018_41609dd1-e7df-46ba-8d3d-0e92a26d70a6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Oxaceprol,33996-33-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 1 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/328891ae-10fd-45d7-95ac-e2dbd8f36d71/documents/06326849-d69f-41c0-a524-10a30f7cc2d1_41609dd1-e7df-46ba-8d3d-0e92a26d70a6.html,,,,,, Oxaceprol,33996-33-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/328891ae-10fd-45d7-95ac-e2dbd8f36d71/documents/06326849-d69f-41c0-a524-10a30f7cc2d1_41609dd1-e7df-46ba-8d3d-0e92a26d70a6.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Tributyl O-acetylcitrate,77-90-7,"ATBC was administered to rats via diet in a combined chronic/carcinogenicity study over 2 years. For the chronic toxicity part, an interim sacrifice was performed after 52 weeks. Intended daily doses were 100, 300 and 1000 mg/kg bw and the actually achieved doses were met with very low deviations from nominal. The following results were obtained after the 52 weeks chronic period: ATBC induced slight reductions in body weight and food consumption. Changes in clinical chemistry parameters were defined to various parameters indicating adaptive changes of metabolic activation, which were not considered to be of primary toxicological relevance. Further, the adaptive changes were expressed by few macroscopically discernible liver changes, liver weight increase and minimal hepatocellular hypertrophy in individual animals.The NOAEL was given with 300 mg/kg bw/d for males and with 1000 mg/kg bw for females. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3f9ec03-dc63-48ba-a380-e50a93397894/documents/IUC5-e20bf6fd-5fa9-469f-ad77-c0a7205f4f85_61f40e29-84be-4f02-a3f8-36245bedbc70.html,,,,,, Tributyl O-acetylcitrate,77-90-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3f9ec03-dc63-48ba-a380-e50a93397894/documents/IUC5-e20bf6fd-5fa9-469f-ad77-c0a7205f4f85_61f40e29-84be-4f02-a3f8-36245bedbc70.html,Chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Tributyl O-acetylcitrate,77-90-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): There are a lot of data available for the toxicological profile of ATBC. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): good quality ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3f9ec03-dc63-48ba-a380-e50a93397894/documents/IUC5-c8dc05e0-7ce2-4d36-9c58-761eb06aa7f4_61f40e29-84be-4f02-a3f8-36245bedbc70.html,,,,,, Tributyl O-acetylcitrate,77-90-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3f9ec03-dc63-48ba-a380-e50a93397894/documents/IUC5-c8dc05e0-7ce2-4d36-9c58-761eb06aa7f4_61f40e29-84be-4f02-a3f8-36245bedbc70.html,,oral,LD50,"31,500 mg/kg bw",no adverse effect observed, Tributyl O-acetylcitrate,77-90-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3f9ec03-dc63-48ba-a380-e50a93397894/documents/IUC5-c8dc05e0-7ce2-4d36-9c58-761eb06aa7f4_61f40e29-84be-4f02-a3f8-36245bedbc70.html,,dermal,LD50,"1,000 mg/kg bw",no adverse effect observed, Triethyl O-acetylcitrate,77-89-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f898b9ea-68e4-44d8-bb27-8b591d1a02c7/documents/fb479969-14f8-46dd-bd2f-0ac03a0e0659_c0c251c2-526e-461b-ab88-4702323c7d67.html,,oral,LD50,"7,000 mg/kg bw",no adverse effect observed, Triethyl O-acetylcitrate,77-89-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f898b9ea-68e4-44d8-bb27-8b591d1a02c7/documents/fb479969-14f8-46dd-bd2f-0ac03a0e0659_c0c251c2-526e-461b-ab88-4702323c7d67.html,,dermal,LD50,"> 10,000 mg/kg bw",no adverse effect observed, 2-acetoxyethyl stearate,22613-51-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ced7e206-5052-4237-990e-2da34992b80d/documents/00c96eb0-b38a-4a66-9367-9bd872b588bb_7f502bbd-d34b-481d-a45c-ff2d9bb3eaa1.html,,oral,LD50,"4,830 mg/kg bw",no adverse effect observed, "Reaction mass of 1,3-diacetoxypropan-2-yl 12-acetoxyoctadecanoate and 2,3-diacetoxypropyl 12-acetoxyoctadecanoate",736150-63-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/963790ac-79c2-4a23-849b-d06a612f9b74/documents/IUC5-9f82882d-eee9-4d71-9947-3af6a6a7afa5_a75665cf-29c9-46de-b6cc-f3e7296d9ee9.html,,oral,LD50,"5,000 mg/kg bw",, "Reaction mass of 1,3-diacetoxypropan-2-yl 12-acetoxyoctadecanoate and 2,3-diacetoxypropyl 12-acetoxyoctadecanoate",736150-63-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/963790ac-79c2-4a23-849b-d06a612f9b74/documents/IUC5-9f82882d-eee9-4d71-9947-3af6a6a7afa5_a75665cf-29c9-46de-b6cc-f3e7296d9ee9.html,,dermal,LD50,"2,000 mg/kg bw",, Benzofuran-2-yl methyl ketone,1646-26-0," Oral (OECD 401), rat: LD50: > 2000 mg/kg bw (limit test) Dermal (OECD 402), rat: LD50: > 2000 mg/kg bw (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1dae3f55-596d-4d3d-98f1-0a84b7e8a02a/documents/9b4643d5-ed74-4478-8ae1-fd6aee848725_0173a5e7-11c4-4412-9700-4e0bc8e7dfd9.html,,,,,, "[3R-(3α,3aβ,7β,8aα)]-1-(2,3,4,7,8,8a-hexahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl)ethan-1-one",32388-55-9," Subchronic NOAEL (oral, rat, male/female): 80 mg/kg bw/day (OECD 408/GLP) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0768d49-61ea-4e89-8feb-01bf9da23334/documents/IUC5-acb97875-ec29-4a60-afc0-21012ecefa6c_d3937fd7-bb18-44d3-8573-ffbf05733df0.html,,,,,, "[3R-(3α,3aβ,7β,8aα)]-1-(2,3,4,7,8,8a-hexahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl)ethan-1-one",32388-55-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0768d49-61ea-4e89-8feb-01bf9da23334/documents/IUC5-acb97875-ec29-4a60-afc0-21012ecefa6c_d3937fd7-bb18-44d3-8573-ffbf05733df0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat "[3R-(3α,3aβ,7β,8aα)]-1-(2,3,4,7,8,8a-hexahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl)ethan-1-one",32388-55-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0768d49-61ea-4e89-8feb-01bf9da23334/documents/IUC5-acb97875-ec29-4a60-afc0-21012ecefa6c_d3937fd7-bb18-44d3-8573-ffbf05733df0.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,300 mg/kg bw/day,,rat "[3R-(3α,3aβ,7β,8aα)]-1-(2,3,4,7,8,8a-hexahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl)ethan-1-one",32388-55-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0768d49-61ea-4e89-8feb-01bf9da23334/documents/IUC5-acb97875-ec29-4a60-afc0-21012ecefa6c_d3937fd7-bb18-44d3-8573-ffbf05733df0.html,Repeated dose toxicity – local effects,dermal,LOAEL,50 mg/cm2,adverse effect observed,rat "[3R-(3α,3aβ,7β,8aα)]-1-(2,3,4,7,8,8a-hexahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl)ethan-1-one",32388-55-9," LD50 (oral; males/females) = 4500 mg/kg bw (3810 - 5310, 95% C.I)  (Equivalent/similar to 401) LD50 (dermal; males/females) = >5000 mg/kg bw (Equivalent/similar to 402) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0768d49-61ea-4e89-8feb-01bf9da23334/documents/IUC5-d0d2f97c-65ac-462f-840d-0b841450c186_d3937fd7-bb18-44d3-8573-ffbf05733df0.html,,,,,, "[3R-(3α,3aβ,7β,8aα)]-1-(2,3,4,7,8,8a-hexahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl)ethan-1-one",32388-55-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0768d49-61ea-4e89-8feb-01bf9da23334/documents/IUC5-d0d2f97c-65ac-462f-840d-0b841450c186_d3937fd7-bb18-44d3-8573-ffbf05733df0.html,,oral,LD50,"4,500 mg/kg bw",no adverse effect observed, "[3R-(3α,3aβ,7β,8aα)]-1-(2,3,4,7,8,8a-hexahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl)ethan-1-one",32388-55-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0768d49-61ea-4e89-8feb-01bf9da23334/documents/IUC5-d0d2f97c-65ac-462f-840d-0b841450c186_d3937fd7-bb18-44d3-8573-ffbf05733df0.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Chromium, 3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonic acid complex",5610-64-0," oral, rats, LD50 > 8587 mg/kg dermal, rats, LD50 (LD0) > 5000 mg/kg ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff71ee09-9e4c-433e-8333-8833fc587b78/documents/ca9746dc-c2e6-4fc1-879f-4f8416d8a6ff_acd0512d-515c-40fa-bc99-592a4a8bc500.html,,,,,, "Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt",129-17-9,"Repeated Dose toxicity (Oral): The No observed adverse effect level taken from a peer reviewed publication is reported to be 375 mg/kg bw when rats were repeatedly exposed to the test chemical (C.I. Food Blue 3) for a 90 day period.Repeated Dose toxicity (Inhalation): The estimated vapour pressure of the chemical hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt is very low  i.e. 1.145239e-31 Pascal. With such low vapour pressure, repeated exposure by the inhaltion route is highly unlikely. Thus, this end point was considered for waiver since no adverse effect by this route are expected.Repeated dose toxicity (Dermal): The chemical hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt (Synonym C.I. Food Blue 3) is dominantly used as a food color. THus, repeated exposure by the dermal route is highly unlikely. Hence this end point was considered for waiver since no adverse effect by this route are expected.. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/dba422bb-6a67-41f5-8080-341f40f5cffa/documents/IUC5-353a7f5a-5e9b-4ddb-8406-8bbcee8b597a_49d1ca97-65df-4659-8446-4a8e2db14013.html,,,,,, "Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt",129-17-9,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/dba422bb-6a67-41f5-8080-341f40f5cffa/documents/IUC5-353a7f5a-5e9b-4ddb-8406-8bbcee8b597a_49d1ca97-65df-4659-8446-4a8e2db14013.html,Chronic toxicity – systemic effects,oral,NOAEL,375 mg/kg bw/day,,rat "Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt",129-17-9,"The chemical hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt (Synonym C.I. Food Blue 3) is unlikely to exhibit acute toxicity by the oral and inhalation route of exposure. However, predicted data using the OECD recommended QSAR indicated that it is likely to cause acute dermal toxicity in Category 4. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dba422bb-6a67-41f5-8080-341f40f5cffa/documents/IUC5-6b6e3331-25d0-44fe-9dc1-169dd82a79d7_49d1ca97-65df-4659-8446-4a8e2db14013.html,,,,,, "Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt",129-17-9,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dba422bb-6a67-41f5-8080-341f40f5cffa/documents/IUC5-6b6e3331-25d0-44fe-9dc1-169dd82a79d7_49d1ca97-65df-4659-8446-4a8e2db14013.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, sodium salt",129-17-9,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dba422bb-6a67-41f5-8080-341f40f5cffa/documents/IUC5-6b6e3331-25d0-44fe-9dc1-169dd82a79d7_49d1ca97-65df-4659-8446-4a8e2db14013.html,,dermal,LD50,"1,313.588 mg/kg bw",adverse effect observed, "Bis[hydrogen [4-[4-(diethylamino)-5'-hydroxy-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium], calcium salt",3536-49-0, NOAEL = 500 mg/kg bw/day LOAEL = 1500 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62c3cc67-f5a9-4bce-859a-976a3ec68a50/documents/e86f7816-39fa-4bd0-895a-64d29b84a276_bffbb15b-11bf-4698-86e8-86afe389ab57.html,,,,,, "Bis[hydrogen [4-[4-(diethylamino)-5'-hydroxy-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium], calcium salt",3536-49-0, LD50 rat oral route > 5000 mg/kg/bw LD50 mouse oral route > 3000 mg/Kg/bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62c3cc67-f5a9-4bce-859a-976a3ec68a50/documents/22683470-81cc-42c9-8aea-140a924593bb_bffbb15b-11bf-4698-86e8-86afe389ab57.html,,,,,, "Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",4368-56-3,LD50 oral = 9476.1 mg/kg bwLD50 dermal > 5020 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0d1d997-4507-4bd3-b832-059d526c6573/documents/IUC5-58eb176a-391f-4a15-86ae-7ec1489dc8bd_bfe7429e-10c9-4214-ac01-b2617c7b018a.html,,,,,, "Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",4368-56-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0d1d997-4507-4bd3-b832-059d526c6573/documents/IUC5-58eb176a-391f-4a15-86ae-7ec1489dc8bd_bfe7429e-10c9-4214-ac01-b2617c7b018a.html,,oral,LD50,"9,476.1 mg/kg bw",no adverse effect observed, "Sodium 1-amino-4-(cyclohexylamino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",4368-56-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0d1d997-4507-4bd3-b832-059d526c6573/documents/IUC5-58eb176a-391f-4a15-86ae-7ec1489dc8bd_bfe7429e-10c9-4214-ac01-b2617c7b018a.html,,dermal,LD50,"5,020 mg/kg bw",no adverse effect observed, "Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate",860-22-0,Acute oral toxicity:The acute oral LD50 value of substance Indigocarmine is considered to be >2000 mg/kg ddY mice. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c884507e-42d8-45cf-8e31-e084122c1d4d/documents/IUC5-ac2c2ae6-b929-435c-a099-4ab171532677_6c17322a-f691-4a71-9262-8200aa6e9a7a.html,,,,,, "Disodium 5,5'-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate",860-22-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c884507e-42d8-45cf-8e31-e084122c1d4d/documents/IUC5-ac2c2ae6-b929-435c-a099-4ab171532677_6c17322a-f691-4a71-9262-8200aa6e9a7a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aluminium, 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid complex",16521-38-3," Acute oral Toxicity:  In Acute oral toxicity, LD50-Cut-off value for target substance Aluminium, 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2 ,3-dihydro- 3-oxo-1H-indole-5-sulfonic acid complex (CAS No. 16521-38-3) was considered to be 5000 mg/kg bw. The study concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Aluminium, 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2 ,3-dihydro- 3-oxo-1H-indole-5-sulfonic acid complex (CAS No. 16521-38-3) cannot be classified for acute oral toxicity. Acute Dermal Toxicity: In Acute dermal toxicity, LD50 value for target substance Aluminium, 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2 ,3-dihydro- 3-oxo-1H-indole-5-sulfonic acid complex (CAS No. 16521-38-3) was considered to be >2000 mg/kg bw. The study concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Aluminium, 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2 ,3-dihydro- 3-oxo-1H-indole-5-sulfonic acid complex (CAS No. 16521-38-3)cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/beb8fa14-6657-4ea9-bb6f-8416d7876d0c/documents/ac64c945-0588-4e97-914c-adc573b238a5_03012be9-21e9-4298-af34-b559c09ec7d6.html,,,,,, "Aluminium, 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid complex",16521-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/beb8fa14-6657-4ea9-bb6f-8416d7876d0c/documents/ac64c945-0588-4e97-914c-adc573b238a5_03012be9-21e9-4298-af34-b559c09ec7d6.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Aluminium, 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid complex",16521-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/beb8fa14-6657-4ea9-bb6f-8416d7876d0c/documents/ac64c945-0588-4e97-914c-adc573b238a5_03012be9-21e9-4298-af34-b559c09ec7d6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)]amino]-2'-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt",3844-45-9," CAS 3844 -45 -9 has been investigated in several studies, most of them being done prior to the introduction of GLP and harmonized testing guidelines. The European Food Safety Agency (EFSA) re-evaluated all available experimental data in 2010 ( EFSA Journal 2010;8(11):)1853) and for the use as a colorant of food stuff (E133) issued an acceptable daily intake of 6 mg/kg bw derived from a NOEL of 631 mg/kg bw reported in a chronic feeding study in rats (Borzelleca 1990). The EFSA evaluation contains all repeated-dose toxicity hazard information that was available for the EU REACH registration in 2017. The high molecular weight and the octanol-water-partition coefficient indicate that the substance is unlikely to penetrate the skin. An assessment of the inhalation route is not performed as the substance is not volatile and handled in a non-inhalable form (granules / water-based solutions). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1eedba5-22c9-4820-94d1-6db437597cb4/documents/a00d9f36-9712-4e98-8146-da81ca3ff842_46c0e332-0ff1-47f0-b813-efd2a88ce577.html,,,,,, "Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)]amino]-2'-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt",3844-45-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1eedba5-22c9-4820-94d1-6db437597cb4/documents/a00d9f36-9712-4e98-8146-da81ca3ff842_46c0e332-0ff1-47f0-b813-efd2a88ce577.html,Chronic toxicity – systemic effects,oral,NOAEL,631 mg/kg bw/day,,rat "Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)]amino]-2'-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt",3844-45-9,No acute oral toxicity was observed in rats after a single gavage dose of 1900 mg/kg bw. Poorly documented data on intraperitoneal injection also shows that the substance is of low toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1eedba5-22c9-4820-94d1-6db437597cb4/documents/373c4778-7aef-4746-bb2e-699793b7f5a9_46c0e332-0ff1-47f0-b813-efd2a88ce577.html,,,,,, "Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)]amino]-2'-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt",3844-45-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1eedba5-22c9-4820-94d1-6db437597cb4/documents/373c4778-7aef-4746-bb2e-699793b7f5a9_46c0e332-0ff1-47f0-b813-efd2a88ce577.html,,oral,discriminating dose,"1,900 ",no adverse effect observed, "Dihydrogen (ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, aluminium salt",68921-42-6," Repeated dose toxicity: Oral Based on the data available, the No Observed Adverse Effect Level (NOAEL) for the test chemical was considered to be in range of 500 -2500 mg/Kg bw using male and female rats or mice . Hence the test chemical is not likely to be toxic upon repeated exposure by oral route as per the criteria mentioned in CLP regulation. Repeated dose toxicity: inhalation The melting point of test chemical is >300 °C.This suggests that test chemical decomposes above300 °C without melting and also it does not exhibit very high vapour pressure. Inhalation is therefore not the likely route of exposure and hence this end point is considered for waiver. Repeated dose toxicity: dermal Repeated dermal toxicity is unlikely to occur since dermal absorption of test chemical is limited. Also considering the use of the chemical as a colouring agent in food and cosmetics and considering the volatility absorption by the dermal route is not considered to be significant. Thus, given the above considerations, it is assumed that test chemical shall not exhibit acute dose toxicity by the repeated dermal route. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6455ce45-3e18-447e-866e-6a07e06a5963/documents/dfc64762-40c4-40a9-a62b-f9400aef4a2e_699cc611-fc91-41a7-bddf-75111637d06a.html,,,,,, "Dihydrogen (ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, aluminium salt",68921-42-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6455ce45-3e18-447e-866e-6a07e06a5963/documents/dfc64762-40c4-40a9-a62b-f9400aef4a2e_699cc611-fc91-41a7-bddf-75111637d06a.html,Chronic toxicity – systemic effects,oral,NOAEL,"2,500 mg/kg bw/day",,rat "Dihydrogen (ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, aluminium salt",68921-42-6," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to very low vapour pressure of the test chemical. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6455ce45-3e18-447e-866e-6a07e06a5963/documents/ad1b6699-42a8-4d2a-a5f3-2a628ad19968_699cc611-fc91-41a7-bddf-75111637d06a.html,,,,,, "Dihydrogen (ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, aluminium salt",68921-42-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6455ce45-3e18-447e-866e-6a07e06a5963/documents/ad1b6699-42a8-4d2a-a5f3-2a628ad19968_699cc611-fc91-41a7-bddf-75111637d06a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Dihydrogen (ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, aluminium salt",68921-42-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6455ce45-3e18-447e-866e-6a07e06a5963/documents/ad1b6699-42a8-4d2a-a5f3-2a628ad19968_699cc611-fc91-41a7-bddf-75111637d06a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Diammonio(ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium",2650-18-2," NOAEL (repeated oral toxicity, chronic study, male rat) = 1072 mg/kg bw/ day NOAEL (repeated oral toxicity, chronic study, female rat) = 631 mg/kg bw/ day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/40ef82cb-929f-44d5-bc50-dd78dcb773a6/documents/dbf5eead-3776-4ba4-91ad-e13b64899d07_4d84b597-1873-41b1-be5a-43c1813eb639.html,,,,,, "Diammonio(ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium",2650-18-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/40ef82cb-929f-44d5-bc50-dd78dcb773a6/documents/dbf5eead-3776-4ba4-91ad-e13b64899d07_4d84b597-1873-41b1-be5a-43c1813eb639.html,Chronic toxicity – systemic effects,oral,NOAEL,631 mg/kg bw/day,,rat "Diammonio(ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium",2650-18-2,LC50 > 1900 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40ef82cb-929f-44d5-bc50-dd78dcb773a6/documents/f404f67f-c943-4bdb-99ca-01521442c638_4d84b597-1873-41b1-be5a-43c1813eb639.html,,,,,, "Diammonio(ethyl)[4-[[4-[ethyl(3-sulphonatobenzyl)amino]phenyl](2-sulphonatophenyl)methylene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium",2650-18-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40ef82cb-929f-44d5-bc50-dd78dcb773a6/documents/f404f67f-c943-4bdb-99ca-01521442c638_4d84b597-1873-41b1-be5a-43c1813eb639.html,,oral,discriminating dose,"1,900 mg/kg bw",no adverse effect observed, Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate,633-96-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e42839e7-44cd-48c0-aa5d-de876729086e/documents/IUC5-72625a6d-0f5a-4f57-959b-c390426fcf64_64622082-7e57-4454-ae26-a1808113c0cb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,2.5 mg/kg bw/day,,rat Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate,633-96-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e42839e7-44cd-48c0-aa5d-de876729086e/documents/IUC5-72625a6d-0f5a-4f57-959b-c390426fcf64_64622082-7e57-4454-ae26-a1808113c0cb.html,Chronic toxicity – systemic effects,dermal,NOAEL,4 mg/kg bw/day,,mouse Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate,633-96-5,NOAEL oral rat > 5000 mg/kgNOAEL dermal mouse = not determined ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e42839e7-44cd-48c0-aa5d-de876729086e/documents/IUC5-9d52b61c-c050-4cff-abdd-9805395c4eb9_64622082-7e57-4454-ae26-a1808113c0cb.html,,,,,, Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate,633-96-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e42839e7-44cd-48c0-aa5d-de876729086e/documents/IUC5-9d52b61c-c050-4cff-abdd-9805395c4eb9_64622082-7e57-4454-ae26-a1808113c0cb.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium 4-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate,633-96-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e42839e7-44cd-48c0-aa5d-de876729086e/documents/IUC5-9d52b61c-c050-4cff-abdd-9805395c4eb9_64622082-7e57-4454-ae26-a1808113c0cb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium 1-(1-naphthylazo)-2-hydroxynaphthalene-4',6,8-trisulphonate",2611-82-7, NOAEL = 500 mg/kg bw/d ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4060b2ab-5c58-4eb6-87de-9fa35f1de303/documents/IUC5-4a533624-c077-4cf1-a47d-a9e5656a2be3_70b17248-6f22-496c-a61e-7d1180b5220a.html,,,,,, "Trisodium 1-(1-naphthylazo)-2-hydroxynaphthalene-4',6,8-trisulphonate",2611-82-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4060b2ab-5c58-4eb6-87de-9fa35f1de303/documents/IUC5-4a533624-c077-4cf1-a47d-a9e5656a2be3_70b17248-6f22-496c-a61e-7d1180b5220a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Trisodium 1-(1-naphthylazo)-2-hydroxynaphthalene-4',6,8-trisulphonate",2611-82-7, LD50 > 8000 mg/kg LD0 = 8000 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4060b2ab-5c58-4eb6-87de-9fa35f1de303/documents/IUC5-e179c382-93f0-43f6-ae58-b6c184bb8d79_70b17248-6f22-496c-a61e-7d1180b5220a.html,,,,,, "Trisodium 3-hydroxy-4-(4'-sulphonatonaphthylazo)naphthalene-2,7-disulphonate",915-67-3, Acute Oral: The acute oral LD50 in male DDY mice was determined to be greater than 2000 mg/kg after dosing with Amaranth dye. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1e9d654-b544-4f9d-bf9c-902140ebff9f/documents/IUC5-9a122610-676c-4c95-a000-cef778225277_0dfb6c1d-9ed4-487a-8d53-e4f916b4b681.html,,,,,, "Trisodium 3-hydroxy-4-(4'-sulphonatonaphthylazo)naphthalene-2,7-disulphonate",915-67-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1e9d654-b544-4f9d-bf9c-902140ebff9f/documents/IUC5-9a122610-676c-4c95-a000-cef778225277_0dfb6c1d-9ed4-487a-8d53-e4f916b4b681.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aluminium, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl)azo]-2,7-naphthalenedisulfonic acid complex",12227-62-2," Repeated dose toxicity: Oral: Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for Aluminium, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl)azo]-2,7- naphthalene disulfonic acid complex. The study assumed the use of male and female Wistar rats in a 90 days toxicity study. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Level (NOAEL) for Aluminium, 3-hydroxy-4-[(4-sulfo- 1-naphthalenyl)azo]-2,7-naphthalene disulfonic acid complex is predicted to be 1069.599975586 mg/Kg bw/day.   Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. Repeated dose toxicity: Inhalation Aluminium, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl)azo]-2,7-naphthalenedisulfonic acid complex has very low vapor pressure of 4.51E-23 mm Hg, so the potential for the generation of inhalable vapurs is very low, also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore is end point was considered for waiver Repeated dose toxicity: Dermal The acute dermal toxicity value for Aluminium, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl)azo]-2,7- naphthalene disulfonic acid complex (as provided in section 7.2.3) based on the data available from the read across chemicals is >2000 mg/kg body weight. The substance was also considered to be not irritating and not sensitizing to the skin on the basis of read across data. Based on these considerations, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/18d30a9c-97cf-4edd-b44d-ead348d3338b/documents/0d432470-e47a-468f-9882-96c07cd0d841_7e786fa0-362c-415e-bf53-c77e3109ff09.html,,,,,, "Aluminium, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl)azo]-2,7-naphthalenedisulfonic acid complex",12227-62-2,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/18d30a9c-97cf-4edd-b44d-ead348d3338b/documents/0d432470-e47a-468f-9882-96c07cd0d841_7e786fa0-362c-415e-bf53-c77e3109ff09.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,069.6 mg/kg bw/day",,rat "Aluminium, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl)azo]-2,7-naphthalenedisulfonic acid complex",12227-62-2," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target Aluminium, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl)azo]-2,7-naphthalenedisulfonic acid complex (12227-62-2)was estimated to be 3563.15 mg/kg bw, and for different studies available on the structurally similar read across substance Disodium 5-amino-4-hydroxy-3-(phenylazo) naphthalene-2, 7-disulphonate (3567-66-6) was considered to be 5000 mg/kg bw and for Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (3734-67-6) was considered to be >2000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Aluminium, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl)azo]-2,7-naphthalenedisulfonic acid complex (12227-62-2) cannot be classified for acute oral toxicity.   Acute Inhalation Toxicity:  Aluminium, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl)azo]-2,7-naphthalenedisulfonic acid complex has very low vapour pressure of 4.51E-23 mm Hg, so the potential for the generation of inhalable vapurs is very low, also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore is end point was considered for waiver Acute Dermal Toxicity: In Acute dermal toxicity, LD50 value was predicted based on OECD QSAR toolbox for target substance Aluminium, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl)azo]-2,7-naphthalenedisulfonic acid complex (12227-62-2) was estimated to be 9503.62 mg/kg bw, and for different studies available on structurally similar read across substance Disodium 5-amino-4-hydroxy-3-(phenylazo) naphthalene-2, 7-disulphonate (3567-66-6)and Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (3734-67-6) was considered to be >2000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Aluminium, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl)azo]-2,7-naphthalenedisulfonic acid complex (12227-62-2) cannot be classified for acute dermal toxicity.   ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18d30a9c-97cf-4edd-b44d-ead348d3338b/documents/337c65f1-4261-47d2-97cc-3014c3000460_7e786fa0-362c-415e-bf53-c77e3109ff09.html,,,,,, "Aluminium, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl)azo]-2,7-naphthalenedisulfonic acid complex",12227-62-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18d30a9c-97cf-4edd-b44d-ead348d3338b/documents/337c65f1-4261-47d2-97cc-3014c3000460_7e786fa0-362c-415e-bf53-c77e3109ff09.html,,oral,LD50,"3,563.15 mg/kg bw",no adverse effect observed, "Aluminium, 3-hydroxy-4-[(4-sulfo-1-naphthalenyl)azo]-2,7-naphthalenedisulfonic acid complex",12227-62-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18d30a9c-97cf-4edd-b44d-ead348d3338b/documents/337c65f1-4261-47d2-97cc-3014c3000460_7e786fa0-362c-415e-bf53-c77e3109ff09.html,,dermal,LD50,"9,503.62 mg/kg bw",no adverse effect observed, "Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate",3567-66-6,"Based on the QSAR prediction done using the Danish (Q)SAR Database, the LD50 was estimated to be 3700 mg/kg/d on rat for substance disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate. Thus based on this value it can be concluded that the substance can be classified as non toxic as per the criteria of CLP regulation. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f5ded5d-d13e-4db4-96de-52583af5d7cb/documents/IUC5-b5789f3c-30f1-4b3c-8674-0c2113013a1f_4ae6d794-019b-4890-b02a-5ed64180eade.html,,,,,, "Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate",3567-66-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f5ded5d-d13e-4db4-96de-52583af5d7cb/documents/IUC5-b5789f3c-30f1-4b3c-8674-0c2113013a1f_4ae6d794-019b-4890-b02a-5ed64180eade.html,,oral,LD50,"3,700 mg/kg bw",no adverse effect observed, "Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate",16423-68-0," Repeated Dose Toxicity Oral In a Combined repeated dose & carcinogenicity study, Charles River CD male and female rats were exposed to the test chemical. The studies consisted of an in utero and an F1 phase. In the former, the chemical was administered to five groups of the F 0 generation rats (60 of each sex/group) at levels of 0.0, 0.0, 0.1, 0.5 or 1.0% ('original study') and 0.0 or 4.0% ('high-dose study').Food consumption increased in all treated groups in a dose-related manner. In male rats, thyroid cystic follicular cell hyperplasia, follicular cysts, follicular adenomas and carcinomas were observed in 4.0 % treated rats of original study and chronic study.When treated with 0.5 %, thyroid cystic follicular cell hyperplasia was observed in original study rats.In female rats, when treated with 0.5 and 4.0 %, follicular adenoma was observed.When treated with 1.0 % in female rats, follicular adenomas and carcinomas were observed. The observed changes in female rat are not statistically significant as compared control. NOAEL was considered to be 0.5 % (251 mg/kg/day) for male rats and 1.0 % (641 mg/kg/day) for female rats when treated with the test chemical. Repeated Dose Inhalation Toxicity A short-term toxicity study need not be conducted as exposure of humans via inhalation route during production/use is highly unlikely based on thorough and rigorous exposure assessment provided. Taking into account the low vapour pressure of the substance (7.572711605e-21 Pascal), the exposure to the test chemical via inhalation is highly unlikely. Hence this endpoint can be considered for waiver. Repeated Dose Dermal Toxicity A short-term toxicity study need not be conducted as exposure of humans via dermal route during production/use is highly unlikely based on thorough and rigorous exposure assessment provided. The acute dermal LD50 (section 7.2.3) was greater than 2000 mg/kg. Hence, this study can be considered for waiver ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df93c444-7fc5-4f5c-aba1-9a613edd81b9/documents/7409849e-f4d8-4a69-bfad-9020d28484c8_e81954c1-0181-4eef-bfd3-11c7b0267565.html,,,,,, "Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate",16423-68-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df93c444-7fc5-4f5c-aba1-9a613edd81b9/documents/7409849e-f4d8-4a69-bfad-9020d28484c8_e81954c1-0181-4eef-bfd3-11c7b0267565.html,Chronic toxicity – systemic effects,oral,NOAEL,651 mg/kg bw/day,,rat "Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate",16423-68-0," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is >2000 mg/kg bw for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The study doesnot need to be conducted because exposure of humans via inhalation isnot likely taking in to account, the vapor pressure of the test chemical and/or the possibility of exposure to aerosols, dusts/mists and vapours is highly unlikely. Taking into account the low vapour pressure of the substance (7.572711605e-21 Pascal), acute toxicity by inhalation is unlikely. Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The study concluded that LD50 value is >2000 mg/kg bw for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df93c444-7fc5-4f5c-aba1-9a613edd81b9/documents/fc170b03-4bb2-4e91-8712-bb191b007d23_e81954c1-0181-4eef-bfd3-11c7b0267565.html,,,,,, "Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate",16423-68-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df93c444-7fc5-4f5c-aba1-9a613edd81b9/documents/fc170b03-4bb2-4e91-8712-bb191b007d23_e81954c1-0181-4eef-bfd3-11c7b0267565.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 2-(2,4,5,7-tetraiodo-6-oxido-3-oxoxanthen-9-yl)benzoate",16423-68-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df93c444-7fc5-4f5c-aba1-9a613edd81b9/documents/fc170b03-4bb2-4e91-8712-bb191b007d23_e81954c1-0181-4eef-bfd3-11c7b0267565.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate",17372-87-1," Repeated dose toxicity: Oral The No Observed adverse effect level (NOAEL) for  test chemical  is considered to be in a dose range of 1000mg/kg bw in rats for subchronic study Repeated dose study: Inalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl)benzoate (17372-87-1)which is reported as 8.62571e-13 mmHg at 25 C. Also considering the particle size distribution of the substance the majority of the particles was found to be in the size of 150 micron -10 micron which is much larger size range compared to the inhalable particulate matter .Thus, exposure to inhalable dust, mist and vapour of the chemical Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl)benzoate is highly unlikely. Therefore this study is considered for waiver. Repeated dose study: Dermal The acute toxicity value for Disodium 2-(2, 4, 5, 7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl)benzoate (17372-87-1) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that Disodium 2-(2, 4, 5, 7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl) benzoate shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxo-3H-xanthen-9-yl)benzoate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/68fc1039-74fd-4f55-b5f7-110dec608abd/documents/c05a1da0-b055-4b03-a800-585a9d25b7e9_fa42ef6a-ea87-4ef6-b861-bf749c15fcce.html,,,,,, "Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate",17372-87-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/68fc1039-74fd-4f55-b5f7-110dec608abd/documents/c05a1da0-b055-4b03-a800-585a9d25b7e9_fa42ef6a-ea87-4ef6-b861-bf749c15fcce.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate",17372-87-1," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical.The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity.Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.  Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 2.54E-020 mm Hg = 3.39E-018 Pa at 25 deg C. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The study concluded that the LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68fc1039-74fd-4f55-b5f7-110dec608abd/documents/cb1e0764-f3eb-48a5-b4a1-a821f5ff25cb_fa42ef6a-ea87-4ef6-b861-bf749c15fcce.html,,,,,, "Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate",17372-87-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68fc1039-74fd-4f55-b5f7-110dec608abd/documents/cb1e0764-f3eb-48a5-b4a1-a821f5ff25cb_fa42ef6a-ea87-4ef6-b861-bf749c15fcce.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate",17372-87-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68fc1039-74fd-4f55-b5f7-110dec608abd/documents/cb1e0764-f3eb-48a5-b4a1-a821f5ff25cb_fa42ef6a-ea87-4ef6-b861-bf749c15fcce.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid",18472-87-2," Repeated dose toxicity: oral In a repeated dose oral toxicity study, Fischer-344 (F-344) male rats were treated with3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydr oxy-3-oxoxanthen-9-yl) benzoic acid (D&C Red No. 28) (CAS Number: 18472-87-2) orally in diet in the concentration of 500 mg/kg/day. Increase in body weight gain was observed in treated rats. As there is no control in the study the effect were not supposed to be treatment related. Daily intake would be 500 mg/kg for 14 days. Therefore, NOAEL was considered to be 500 mg/kg/day on the basis of body weight when Fischer-344 (F-344) male rats were treated with3,4,5,6-tetrachloro-2-(1,4,5,8 -tetrabromo-6-hydr oxy-3-oxoxanthen-9-yl)benzoic acid (D&C Red No. 28) (CAS Number: 18472-87-2)for 14 days. Repeated dose toxicity: Inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid, which is reported as 3.12E-021 Pa. Also considering the particle size distribution of the substance, the majority of the particles were found to be in the size of 75.0 micrometer which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (CAS Number: 18472-87-2) is highly unlikely. Therefore this study is considered for waiver. Repeated dose toxicity: Dermal The acute toxicity value for 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not irrtating to skin. Also, given the use of the chemical as dye; repeated exposure by the dermal route is unlikely. Thus, it is expected that 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no dermal absorption data as well as no data available that suggests that 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/682eebdb-1ddf-41fd-8fef-e408335a25ff/documents/6bae9b0e-5ad2-4be3-aeb3-1155e1d03513_c555a537-2d35-4748-bb58-a46f664af102.html,,,,,, "3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid",18472-87-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/682eebdb-1ddf-41fd-8fef-e408335a25ff/documents/6bae9b0e-5ad2-4be3-aeb3-1155e1d03513_c555a537-2d35-4748-bb58-a46f664af102.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid",18472-87-2," Acute toxicity: oral The acute oral LD50 of 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (CAS No. 18472-87-2) was >2000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of 3,4,5,6-tetrachloro-2-(1,4,5,8- tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (CAS No. 18472-87-2), when administered via oral route (gavage) in Sprague Dawley rats falls into the “Category not classified” as per criteria of CLP.   Acute toxicity: dermal The acute dermal median lethal dose (LD50) of 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid, when administered to male and female Sprague Dawley rats was considered to be greater than 2000 mg/kg body weight. Thus according to CLP criteria for acute toxicity rating for the chemicals, it infers that 3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid (CAS No. 18472-87-2) does not classify as an acute dermal toxicant. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/682eebdb-1ddf-41fd-8fef-e408335a25ff/documents/7c7c7863-9980-4be6-9021-b136c8833442_c555a537-2d35-4748-bb58-a46f664af102.html,,,,,, "3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid",18472-87-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/682eebdb-1ddf-41fd-8fef-e408335a25ff/documents/7c7c7863-9980-4be6-9021-b136c8833442_c555a537-2d35-4748-bb58-a46f664af102.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,4,5,6-tetrachloro-2-(1,4,5,8-tetrabromo-6-hydroxy-3-oxoxanthen-9-yl)benzoic acid",18472-87-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/682eebdb-1ddf-41fd-8fef-e408335a25ff/documents/7c7c7863-9980-4be6-9021-b136c8833442_c555a537-2d35-4748-bb58-a46f664af102.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate",4430-18-6," According to the key studies results (Klimisch 1, GLP compliant study, OECD Guideline 408 method), the main adverse effect was an increase of Activated Partial Thromboplastine. Hence the No Observed Adverse Effect Level was defined as 200 mg/kg bw/day in rats exposed to the test item Jarocol Violet 43, according CLP classification. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c3fc7f3-7168-4ba7-bdf8-fd39f34e4bb5/documents/4a2fc52e-e5e4-4dd9-941e-8d7afdd83c8b_62dd8344-b983-41c4-9249-6526a4162f62.html,,,,,, "Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate",4430-18-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c3fc7f3-7168-4ba7-bdf8-fd39f34e4bb5/documents/4a2fc52e-e5e4-4dd9-941e-8d7afdd83c8b_62dd8344-b983-41c4-9249-6526a4162f62.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate",4430-18-6," The registered item Acid Violet 43 is not classified as acute oral hazard according to the key study (GLP, OECD Guideline 401 followed, Klimisch 2) and the CLP regulation. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c3fc7f3-7168-4ba7-bdf8-fd39f34e4bb5/documents/25a969c9-76cb-42a9-9c5e-a8075da1d510_62dd8344-b983-41c4-9249-6526a4162f62.html,,,,,, "Sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate",4430-18-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c3fc7f3-7168-4ba7-bdf8-fd39f34e4bb5/documents/25a969c9-76cb-42a9-9c5e-a8075da1d510_62dd8344-b983-41c4-9249-6526a4162f62.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate,1934-21-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b8e7f94-32c3-4ca5-a52d-7299a92cba3f/documents/IUC5-2d910061-4ee2-4c92-9df6-2320ba7301de_3fed2967-7810-4e36-bb5f-a21859c15542.html,Chronic toxicity – systemic effects,oral,NOAEL,"8,103 mg/kg bw/day",,rat Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate,1934-21-0,"Migrated Data from field(s)Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Expert judgement based on available information. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b8e7f94-32c3-4ca5-a52d-7299a92cba3f/documents/IUC5-d1abfdea-0e38-4406-b793-ba6b4998f6ad_3fed2967-7810-4e36-bb5f-a21859c15542.html,,,,,, Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate,1934-21-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b8e7f94-32c3-4ca5-a52d-7299a92cba3f/documents/IUC5-d1abfdea-0e38-4406-b793-ba6b4998f6ad_3fed2967-7810-4e36-bb5f-a21859c15542.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex",12225-21-7," Repeated dose toxicity: Oral Based on the prediction done using the OECD QSAR toolbox version 3.1 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for aluminum tris(4-{[3-carboxy-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl] diazenyl}benzenesulfonate). The study assumed the use of male and female Sprgue Dawley rats. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Level (NOAEL) for aluminum tris(4-{[3-carboxy-5-oxo-1- (4-sulfophenyl)-4,5-dihydro-1H-pyrazol-4-yl]diazenyl}benzenesulfonate) is predicted to be 2940.66 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. Repeated dose toxicity: Inhalation The test substance aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex has very low vapor pressure [0.000000000000000000000913 (9.13E-022) Pa]. Also the particle size distribution of the substance was found to vary in the size of 150 µm to 600 µm, so the potential for the generation of inhalable vapours of aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex is low. Moreover the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur and therefore repeated dose toxicity via the inhalation route was considered for waiver. Repeated dose toxicity: Dermal Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose dermal toxicity was predicted for the test compound Pigment yellow 100. The study assumed the use of male and female New Zealand White rabbits in 21 days study. No significant alterations were noted at the mentioned dose level. The predicted No Observed Adverse Effect Level (NOAEL) for Pigment yellow 100 is considered to be 87.065673828 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ec91d4e-4b91-492a-88e2-d361852f3b67/documents/IUC5-e3c1e054-ef34-49fc-ab8a-ce45987174ec_bbe9e704-fe5c-4aa2-8037-fae55c0f5d40.html,,,,,, "Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex",12225-21-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ec91d4e-4b91-492a-88e2-d361852f3b67/documents/IUC5-e3c1e054-ef34-49fc-ab8a-ce45987174ec_bbe9e704-fe5c-4aa2-8037-fae55c0f5d40.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,940.66 mg/kg bw/day",,rat "Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex",12225-21-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ec91d4e-4b91-492a-88e2-d361852f3b67/documents/IUC5-e3c1e054-ef34-49fc-ab8a-ce45987174ec_bbe9e704-fe5c-4aa2-8037-fae55c0f5d40.html,Chronic toxicity – systemic effects,dermal,NOAEL,87.066 mg/kg bw/day,,mouse "Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex",12225-21-7," Acute Oral Toxicity:  The acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity:  This data was considered for waiver considering the low vapour pressure of this chemical (0.000000000000000000000913 Pa) as well as the particle size distribution. Majority of the particles were found to be in the size 150 (62.5%) micrometer in size which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex is highly unlikely. Acute Dermal Toxicity: The acute dermal toxicity dose (LD50) was considered based on experimenatl study conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ec91d4e-4b91-492a-88e2-d361852f3b67/documents/IUC5-122797f5-6b91-45b0-86e2-071524f8d7a5_bbe9e704-fe5c-4aa2-8037-fae55c0f5d40.html,,,,,, "Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex",12225-21-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ec91d4e-4b91-492a-88e2-d361852f3b67/documents/IUC5-122797f5-6b91-45b0-86e2-071524f8d7a5_bbe9e704-fe5c-4aa2-8037-fae55c0f5d40.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aluminium, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-1H-pyrazole-3-carboxylic acid complex",12225-21-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ec91d4e-4b91-492a-88e2-d361852f3b67/documents/IUC5-122797f5-6b91-45b0-86e2-071524f8d7a5_bbe9e704-fe5c-4aa2-8037-fae55c0f5d40.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 3-(p-anilinophenylazo)benzenesulphonate,587-98-4," Repeated dose toxicity: oral The No Observed Adverse Effect level (NOAEL) for the test compound sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (metanil yellow) is determined to be 500 mg/Kg bw upon repeated exposure for 180 days to male and female albino mice by oral intubation route. Repeated dose toxicity: inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate, which is reported as 6.93E-16 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate is highly unlikely. Therefore this study is considered for waiver. Repeated dose toxicity: dermal The acute toxicity value for sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (as provided in section 7.2.3) is >2000 mg/kg body weight. Thus, it is expected that sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no dermal absorption data as well as no data available that suggests that sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ceaa223-fc69-4b6c-8b62-8184e7b79b9a/documents/1913c264-2bf2-4edf-a710-7e65d30a0f2e_53be37de-aab4-4622-8fa6-fc6a775c9a47.html,,,,,, Sodium 3-(p-anilinophenylazo)benzenesulphonate,587-98-4,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ceaa223-fc69-4b6c-8b62-8184e7b79b9a/documents/1913c264-2bf2-4edf-a710-7e65d30a0f2e_53be37de-aab4-4622-8fa6-fc6a775c9a47.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,mouse Sodium 3-(p-anilinophenylazo)benzenesulphonate,587-98-4," Acute toxicity: oral The acute oral LD50 value of the test substance sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate (Acid Yellow 36) is determined to be 5000 mg/kg for rats. Acid toxicity: inhalation The study need not be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Acute toxicity: dermal The acute dermal median lethal dose (LD50) value of sodium 3-[(4-anilinophenyl)diazenyl]benzenesulfonate in rabbit was estimated to be 8331.25 mg/kg of body weight, by QSAR toolbox. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ceaa223-fc69-4b6c-8b62-8184e7b79b9a/documents/075108b0-09ae-42a5-9c44-47545321f314_53be37de-aab4-4622-8fa6-fc6a775c9a47.html,,,,,, Sodium 3-(p-anilinophenylazo)benzenesulphonate,587-98-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ceaa223-fc69-4b6c-8b62-8184e7b79b9a/documents/075108b0-09ae-42a5-9c44-47545321f314_53be37de-aab4-4622-8fa6-fc6a775c9a47.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium 3-(p-anilinophenylazo)benzenesulphonate,587-98-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ceaa223-fc69-4b6c-8b62-8184e7b79b9a/documents/075108b0-09ae-42a5-9c44-47545321f314_53be37de-aab4-4622-8fa6-fc6a775c9a47.html,,dermal,LD50,"8,331.25 mg/kg bw",no adverse effect observed, Disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate,518-47-8,LD50 was considered to be 6720 mg/kg bw when rats were treated with Sodium fluorescein orally. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c377440-b66c-4d0a-8feb-56ba48ffa78d/documents/IUC5-bc02f248-3ad0-4290-8710-3eab9a7f8ee6_6ad7bb31-948b-4698-9f9a-fe3bda3d976e.html,,,,,, Disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate,518-47-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c377440-b66c-4d0a-8feb-56ba48ffa78d/documents/IUC5-bc02f248-3ad0-4290-8710-3eab9a7f8ee6_6ad7bb31-948b-4698-9f9a-fe3bda3d976e.html,,oral,LD50,"6,720 mg/kg bw",no adverse effect observed, Acrylic acid,79-10-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): similar to OECD TG 411 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): similar to OECD TG 413 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): similar to OECD TG 413 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): similar to OECD TG 411 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): similar to OECD TG 452 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bef56756-5aad-4df2-b0a5-689e3049309d/documents/IUC5-741d8f6a-367d-468c-a369-ce1151d528f1_fd9871d6-b6da-49a3-84ec-2c8e741e6633.html,,,,,, Acrylic acid,79-10-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bef56756-5aad-4df2-b0a5-689e3049309d/documents/IUC5-741d8f6a-367d-468c-a369-ce1151d528f1_fd9871d6-b6da-49a3-84ec-2c8e741e6633.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,15 mg/m3,,mouse Acrylic acid,79-10-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bef56756-5aad-4df2-b0a5-689e3049309d/documents/IUC5-741d8f6a-367d-468c-a369-ce1151d528f1_fd9871d6-b6da-49a3-84ec-2c8e741e6633.html,Chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat Acrylic acid,79-10-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bef56756-5aad-4df2-b0a5-689e3049309d/documents/IUC5-741d8f6a-367d-468c-a369-ce1151d528f1_fd9871d6-b6da-49a3-84ec-2c8e741e6633.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 mg/m3,adverse effect observed,mouse Acrylic acid,79-10-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): OECD TG 423 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): similar to OECD TG 403 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): OECD TG 402 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bef56756-5aad-4df2-b0a5-689e3049309d/documents/IUC5-22b20a13-8e40-49dc-beaa-7e1c22ca89c2_fd9871d6-b6da-49a3-84ec-2c8e741e6633.html,,,,,, Acrylic acid,79-10-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bef56756-5aad-4df2-b0a5-689e3049309d/documents/IUC5-22b20a13-8e40-49dc-beaa-7e1c22ca89c2_fd9871d6-b6da-49a3-84ec-2c8e741e6633.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, Acrylic acid,79-10-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bef56756-5aad-4df2-b0a5-689e3049309d/documents/IUC5-22b20a13-8e40-49dc-beaa-7e1c22ca89c2_fd9871d6-b6da-49a3-84ec-2c8e741e6633.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Acrylic acid,79-10-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bef56756-5aad-4df2-b0a5-689e3049309d/documents/IUC5-22b20a13-8e40-49dc-beaa-7e1c22ca89c2_fd9871d6-b6da-49a3-84ec-2c8e741e6633.html,,inhalation,LC50,"5,100 mg/m3",adverse effect observed, Acrylonitrile,107-13-1,"Repeated exposure to acrylonitrile by the oral route results in damage to the gastrointestinal tract and neurotoxicity. The respiratory tract is affected following repeated exposure by inhalation; the critical effect of repeated inhalation exposure is identified as local irritation.  For repeated dose toxicity by the oral route, the key study is the F344 rat drinking water study of Johannsen & Levinskas (1980), from which a NOAEL of 3 ppm (equivalent to average daily dose levels of 0.25 mg/kg bw/d in males and 0.36 mg/kg bw/d in females) was derived. For repeated dose inhalation toxicity, the key study is the 2 -generation rat study of Nemec et al. (2008), from which a LOAEC of 5 ppm (11 mg/m3) was determined based on irritant effects on the nasal mucosa. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d7fee9a-ec6c-4f04-93b2-8d1a49b2b324/documents/a78bbdd5-69c2-4cc6-8abb-2b83daa600e6_03ac4443-b358-40f0-9cb5-973bba8afba4.html,,,,,, Acrylonitrile,107-13-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d7fee9a-ec6c-4f04-93b2-8d1a49b2b324/documents/a78bbdd5-69c2-4cc6-8abb-2b83daa600e6_03ac4443-b358-40f0-9cb5-973bba8afba4.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,11 mg/m3,,rat Acrylonitrile,107-13-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d7fee9a-ec6c-4f04-93b2-8d1a49b2b324/documents/a78bbdd5-69c2-4cc6-8abb-2b83daa600e6_03ac4443-b358-40f0-9cb5-973bba8afba4.html,Chronic toxicity – systemic effects,oral,NOAEL,0.25 mg/kg bw/day,,rat Acrylonitrile,107-13-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d7fee9a-ec6c-4f04-93b2-8d1a49b2b324/documents/a78bbdd5-69c2-4cc6-8abb-2b83daa600e6_03ac4443-b358-40f0-9cb5-973bba8afba4.html,Repeated dose toxicity – local effects,inhalation,LOAEC,11 mg/m3,adverse effect observed,rat Acrylonitrile,107-13-1,"The acute toxicity dataset for acrylonitrile is extensive and is reviewed in the EU RAR (2004) and Sapphire Group report (2004).  The results of a guideline-comparable study in the rat show an acute oral LD50 value of 81 (62 -107 mg/kg bw).  In contrast to the results of earlier studies, a modern guideline-compliant study of dermal toxicity in the rat reports an LD50 value of >200 mg/kg bw. In a modern, guideline-comparable study the acute inhalation (4 -hour) LC50 of acrylonitrile in the rat was calculated to be 2.05 mg/L. The EU RAR (2004) reviews the available data on the acute oral toxicity of acrylonitrile. Oral LD50 values for various species are reported to be in the range 25 -186 mg/kg bw with a species sensitivity of mouse>guinea pig>rabbit and rat. The results of a guideline-comparable study in the rat show an acute oral LD50 value of 81 (62 -107) mg/kg bw. A recent, guideline-compliant study is supported by older and largely non-standard data. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d7fee9a-ec6c-4f04-93b2-8d1a49b2b324/documents/b99383a5-4cea-482d-9c90-eec70cf02d22_03ac4443-b358-40f0-9cb5-973bba8afba4.html,,,,,, Acrylonitrile,107-13-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d7fee9a-ec6c-4f04-93b2-8d1a49b2b324/documents/b99383a5-4cea-482d-9c90-eec70cf02d22_03ac4443-b358-40f0-9cb5-973bba8afba4.html,,oral,LD50,81 mg/kg bw,adverse effect observed, Acrylonitrile,107-13-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d7fee9a-ec6c-4f04-93b2-8d1a49b2b324/documents/b99383a5-4cea-482d-9c90-eec70cf02d22_03ac4443-b358-40f0-9cb5-973bba8afba4.html,,dermal,LD50,200 mg/kg bw,adverse effect observed, Acrylonitrile,107-13-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d7fee9a-ec6c-4f04-93b2-8d1a49b2b324/documents/b99383a5-4cea-482d-9c90-eec70cf02d22_03ac4443-b358-40f0-9cb5-973bba8afba4.html,,inhalation,LC50,"2,050 mg/m3",adverse effect observed, "acrylic acid, 3-(trimethoxysilyl)propyl ester",4369-14-6," In the key 28-day oral repeated dose toxicity study (CAS No. 4369-14-6, EC No. 419-560-6), conducted according to OECD Test Guideline 407 and in compliance with GLP (reliability score 2, Hita Research Laboratories, 1994b), the NOAEL for local effects was 40 mg/kg bw/day based on local effects seen in the stomach at higher doses; a NOAEL for systemic toxicity was not concluded in the study report, but it is the reviewer's opinion that it is at least 1000 mg/kg bw/day, the highest dose tested. The local stomach effects are attributed to the corrosive properties of the registered substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2428bc98-3321-4b68-ba6f-25455c3b607b/documents/39de7dad-20f1-4665-90a5-7f0949bbbb10_b7878b17-930f-469d-af26-7a94e0a72d74.html,,,,,, "acrylic acid, 3-(trimethoxysilyl)propyl ester",4369-14-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2428bc98-3321-4b68-ba6f-25455c3b607b/documents/39de7dad-20f1-4665-90a5-7f0949bbbb10_b7878b17-930f-469d-af26-7a94e0a72d74.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "acrylic acid, 3-(trimethoxysilyl)propyl ester",4369-14-6," The key acute oral toxicity study with 3-(trimethoxysilyl)propyl acrylate (CAS No. 4369-14-6, EC No. 419-560-6) was conducted according to the now-deleted OECD Test Guideline 401 and in compliance with GLP (reliability score 1, Hita Research Laboratories, 1994a). The LD50 value in this study was >2000 mg/kg bw in male and female rats.   The key acute inhalation toxicity study with 3-(trimethoxysilyl)propyl acrylate aerosol was conducted according to OECD Test Guideline 403 and in compliance with GLP (reliability score 1, SafePharm Laboratories Limited, 1995c). The LC50 value in this study was 3.79 mg/L aerosol for male and female rats following a 4-hour inhalation exposure.   A dermal study does not need to be conducted because the registered substance is classified as corrosive to the skin. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2428bc98-3321-4b68-ba6f-25455c3b607b/documents/26766aa3-931d-4eca-97da-8d448cc93816_b7878b17-930f-469d-af26-7a94e0a72d74.html,,,,,, "acrylic acid, 3-(trimethoxysilyl)propyl ester",4369-14-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2428bc98-3321-4b68-ba6f-25455c3b607b/documents/26766aa3-931d-4eca-97da-8d448cc93816_b7878b17-930f-469d-af26-7a94e0a72d74.html,,oral,LD50,">=2,000 mg/kg bw",no adverse effect observed, "acrylic acid, 3-(trimethoxysilyl)propyl ester",4369-14-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2428bc98-3321-4b68-ba6f-25455c3b607b/documents/26766aa3-931d-4eca-97da-8d448cc93816_b7878b17-930f-469d-af26-7a94e0a72d74.html,,inhalation,LC50,"3,790 mg/m3",adverse effect observed, 2-[[(butylamino)carbonyl]oxy]ethyl acrylate,63225-53-6," Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, local effects, oral (OECD 422), rat: NOAEL = 100 mg/kg bw/day Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, systemic toxicity, oral (OECD 422), rat: NOAEL = 300 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e23cb7db-c992-48e5-bfaf-b2be5ecfcfb5/documents/17c4bfac-91d2-4169-8a77-b37d4d71f772_5ef9638e-8463-4c82-90e0-1422453ffec7.html,,,,,, 2-[[(butylamino)carbonyl]oxy]ethyl acrylate,63225-53-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e23cb7db-c992-48e5-bfaf-b2be5ecfcfb5/documents/17c4bfac-91d2-4169-8a77-b37d4d71f772_5ef9638e-8463-4c82-90e0-1422453ffec7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 2-[[(butylamino)carbonyl]oxy]ethyl acrylate,63225-53-6,"Oral (OECD 423), rat: LD50 > 2000- 5000 mg/kg bw Inhalation (OECD 436), rat: LC50 > 0.5 - 1 mg/L air (test substance containing > 83.6% of the main compound) Inhalation (OECD 436), rat: LC50 > 1 - 5 mg/L air (test substance containing >=80<84 %  of the main compound) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The available information comprises adequate, reliable (Klimisch score 1) and consistent studies, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e23cb7db-c992-48e5-bfaf-b2be5ecfcfb5/documents/IUC5-6251211f-93b5-4a38-8a00-ab806b09888e_5ef9638e-8463-4c82-90e0-1422453ffec7.html,,,,,, 2-[[(butylamino)carbonyl]oxy]ethyl acrylate,63225-53-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e23cb7db-c992-48e5-bfaf-b2be5ecfcfb5/documents/IUC5-6251211f-93b5-4a38-8a00-ab806b09888e_5ef9638e-8463-4c82-90e0-1422453ffec7.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, 2-[[(butylamino)carbonyl]oxy]ethyl acrylate,63225-53-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e23cb7db-c992-48e5-bfaf-b2be5ecfcfb5/documents/IUC5-6251211f-93b5-4a38-8a00-ab806b09888e_5ef9638e-8463-4c82-90e0-1422453ffec7.html,,inhalation,LC50,0.5 mg/m3,adverse effect observed, Adenine,73-24-5," In an in vivo repeated dose toxicity study in rat similar to OECD 407, an LD50 oral of 227 mg/kg bw was determined (LOAEL = 35 mg/kg bw/d) (reference 7.5.1 -1). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0000ba7f-54f4-4889-9d2d-a71c3d2cd54c/documents/8ecfbb26-0bd0-41f0-8926-1327efdc4372_f42f9f9c-2257-430f-9615-41d53ba7cd27.html,,,,,, Adenine,73-24-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0000ba7f-54f4-4889-9d2d-a71c3d2cd54c/documents/8ecfbb26-0bd0-41f0-8926-1327efdc4372_f42f9f9c-2257-430f-9615-41d53ba7cd27.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,35 mg/kg bw/day,,rat Adenine,73-24-5," Available repeated dose oral toxicity data in rats were used to determine the LD50 of the test substance in accordance with REACH Annex XI, 1.1.2 (7.5.1 -1). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0000ba7f-54f4-4889-9d2d-a71c3d2cd54c/documents/95a727f7-b114-4628-af68-108355bb8ecc_f42f9f9c-2257-430f-9615-41d53ba7cd27.html,,,,,, Adenine,73-24-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0000ba7f-54f4-4889-9d2d-a71c3d2cd54c/documents/95a727f7-b114-4628-af68-108355bb8ecc_f42f9f9c-2257-430f-9615-41d53ba7cd27.html,,oral,LD50,227 mg/kg bw,adverse effect observed, Adipic acid,124-04-9," In a 2-year oral feeding study adipic acid was of low repeated dose toxicity, however it was not tested according to current standards. The NOAEL was 1% for male rats (approx. 750 mg/kg bw/day) and higher doses (3 and 5%) caused body weight retardation with no indication of specific target organ toxicity. The NOAEL for female rats was 1% (approx. 750 mg/kg bw/day), the highest dose tested in females. In humans no symptoms were reported after oral administration of up to 7 g adipic acid per day for up to 10 days to 7 individuals to investigate compound excretion. There is no repeated inhalation toxicity study with histopathological examination of the nose available. There are no studies on repeated inhalation or dermal application available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d0fe7ef-efe9-4c16-bce1-5c24fbe8cc5d/documents/IUC5-b271e00c-a948-4de1-985f-ff46b5f76d53_5fbec5bd-35fc-4c61-b0f5-108ef0551ec6.html,,,,,, Adipic acid,124-04-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d0fe7ef-efe9-4c16-bce1-5c24fbe8cc5d/documents/IUC5-b271e00c-a948-4de1-985f-ff46b5f76d53_5fbec5bd-35fc-4c61-b0f5-108ef0551ec6.html,Chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat Adipic acid,124-04-9, Adipic acid is of very low acute toxicity. The oral and dermal LD50 in rats are > 5000 mg/kg bw. In an acute inhalation test neither mortality nor clinical symptoms were observed during and after 4 hour exposure to 7700 mg/m3 of adipic acid. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d0fe7ef-efe9-4c16-bce1-5c24fbe8cc5d/documents/IUC5-a57baad0-fa2d-436e-bdb0-b0a1304c7a17_5fbec5bd-35fc-4c61-b0f5-108ef0551ec6.html,,,,,, Adipic acid,124-04-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d0fe7ef-efe9-4c16-bce1-5c24fbe8cc5d/documents/IUC5-a57baad0-fa2d-436e-bdb0-b0a1304c7a17_5fbec5bd-35fc-4c61-b0f5-108ef0551ec6.html,,oral,LD50,"5,560 mg/kg bw",, Adipic acid,124-04-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d0fe7ef-efe9-4c16-bce1-5c24fbe8cc5d/documents/IUC5-a57baad0-fa2d-436e-bdb0-b0a1304c7a17_5fbec5bd-35fc-4c61-b0f5-108ef0551ec6.html,,dermal,discriminating dose,"7,940 mg/kg bw",, Adipic acid,124-04-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d0fe7ef-efe9-4c16-bce1-5c24fbe8cc5d/documents/IUC5-a57baad0-fa2d-436e-bdb0-b0a1304c7a17_5fbec5bd-35fc-4c61-b0f5-108ef0551ec6.html,,inhalation,discriminating conc.,"7,700 mg/m3",, Adipohydrazide,1071-93-8," In a GLP-compliant OECD guideline 408 study (90 days) with rats the NOAEL was set at 100 mg/kg bw/day, based on adverse changes in liver at the next dose levels (increased severity in single cell necrosis, changes in clinical liver parameters, weight changes). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a01dd6a-4789-4ed7-9383-1fbac017a930/documents/IUC5-55e44c81-65fe-4a3e-90e4-18e17727dc7c_e31f4eeb-c996-4659-b15c-d11744e3715a.html,,,,,, Adipohydrazide,1071-93-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a01dd6a-4789-4ed7-9383-1fbac017a930/documents/IUC5-55e44c81-65fe-4a3e-90e4-18e17727dc7c_e31f4eeb-c996-4659-b15c-d11744e3715a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Adipohydrazide,1071-93-8,"The acute oral LD50 to rats of adipic acid dihydrazide is greater than 2000 mg/kg bodyweight. The acute inhalation LC50,4h to rats of adipic acid dihydrazide is greater than 5.3 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a01dd6a-4789-4ed7-9383-1fbac017a930/documents/IUC5-cd1c9129-61b1-4d3d-bb35-304f3be5db68_e31f4eeb-c996-4659-b15c-d11744e3715a.html,,,,,, Adipohydrazide,1071-93-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a01dd6a-4789-4ed7-9383-1fbac017a930/documents/IUC5-cd1c9129-61b1-4d3d-bb35-304f3be5db68_e31f4eeb-c996-4659-b15c-d11744e3715a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Adipohydrazide,1071-93-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a01dd6a-4789-4ed7-9383-1fbac017a930/documents/IUC5-cd1c9129-61b1-4d3d-bb35-304f3be5db68_e31f4eeb-c996-4659-b15c-d11744e3715a.html,,inhalation,LC50,"5,300 mg/m3",no adverse effect observed, L-alanine,56-41-7,Information on repeated oral dose toxicity was gathered by read-across from L-alanyl-L-glutamine.A subchronic oral toxicity guideline study of L-alanyl-L-glutamine (L-AG) with rats was conducted for 90 days. No treatment-related significant or toxicologically relevant findings were observed. All data from the oral route of administration suggest that they sufficiently cover the dermal and inhalative routes. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f0a5c1b-a7be-4a9a-9728-775f068f9d15/documents/IUC5-0e35205b-ab2c-458c-b3d4-47527ac0c95b_21a2482f-26e0-49b4-a9e0-05328ea289ab.html,,,,,, L-alanine,56-41-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f0a5c1b-a7be-4a9a-9728-775f068f9d15/documents/IUC5-0e35205b-ab2c-458c-b3d4-47527ac0c95b_21a2482f-26e0-49b4-a9e0-05328ea289ab.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,283 mg/kg bw/day",,rat L-alanine,56-41-7,An acute oral LD50 value of > 5110mg/kg bw from a reliable study was derived. No mortality occurred during the observation period of 14days. No signs of toxicity were observed either at the male nor the female animals.The acute dermal study and the acute inhalation study were waived based on the very low systemic toxicity as well as on the physico-chemical and toxikokinetic properties. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f0a5c1b-a7be-4a9a-9728-775f068f9d15/documents/IUC5-7d0313e8-2beb-4089-80e1-b05e82effded_21a2482f-26e0-49b4-a9e0-05328ea289ab.html,,,,,, L-alanine,56-41-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f0a5c1b-a7be-4a9a-9728-775f068f9d15/documents/IUC5-7d0313e8-2beb-4089-80e1-b05e82effded_21a2482f-26e0-49b4-a9e0-05328ea289ab.html,,oral,LD50,"5,110 mg/kg bw",no adverse effect observed, Ethanol,64-17-5," Oral route (mg/kgbw/day): Rat NOAEL (90 day): 1730, 3250 (male), 3900 (male/female), <4400 (female).  LOAEL (90 day): 3160 Mouse NOAEL (90 day) >9400 (female), <9700 (male) Monkey NOEL (chronic) <6200mg/kg/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a59b447-50d5-42a8-b6a4-14a48f991cb9/documents/IUC5-4a597698-9419-4ae2-ba40-171782ecbb0c_29b8b5ec-9c01-4e61-a7c5-66507ffd2ac5.html,,,,,, Ethanol,64-17-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a59b447-50d5-42a8-b6a4-14a48f991cb9/documents/IUC5-4a597698-9419-4ae2-ba40-171782ecbb0c_29b8b5ec-9c01-4e61-a7c5-66507ffd2ac5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,730 mg/kg bw/day",,rat Ethanol,64-17-5,"ORAL (LD50 values)Rat: female: 15010mg/kg; male (young adult): 10600mg/kg; male (old adult); 7060mg/kg; not sex specific: old adult: 11500mg/kg; young adult: 17750mg/kg; immature animal: 6160mg/kg, ~12000mg/kg, male/female :10470mg/kg; >7692mg/kg (female).Mouse: 8350mg/kgHuman: LD50 ~2000mg/kgINHALATIONRat (4hr): LC50: male: 51mg/l, female: 55mg/lMouse: LC50>60000ppmDERMALNo reliable data. Information indicates LC50>15800mg/lINTRAPERITONEAL (LD50 values)Rat: young animals LD50 5500-6710mg/kg. Old animals LD50: 4070-5100mg/kgMouse: Male 9020, 9710mg/kg. Female: 9450mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a59b447-50d5-42a8-b6a4-14a48f991cb9/documents/IUC5-a2234835-9721-477e-9da5-20a17322145e_29b8b5ec-9c01-4e61-a7c5-66507ffd2ac5.html,,,,,, Ethanol,64-17-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a59b447-50d5-42a8-b6a4-14a48f991cb9/documents/IUC5-a2234835-9721-477e-9da5-20a17322145e_29b8b5ec-9c01-4e61-a7c5-66507ffd2ac5.html,,oral,LD50,"10,470 mg/kg bw",, Ethanol,64-17-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a59b447-50d5-42a8-b6a4-14a48f991cb9/documents/IUC5-a2234835-9721-477e-9da5-20a17322145e_29b8b5ec-9c01-4e61-a7c5-66507ffd2ac5.html,,dermal,LD50,"15,800 mg/kg bw",, Ethanol,64-17-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a59b447-50d5-42a8-b6a4-14a48f991cb9/documents/IUC5-a2234835-9721-477e-9da5-20a17322145e_29b8b5ec-9c01-4e61-a7c5-66507ffd2ac5.html,,inhalation,LC50,"50,000 mg/m3",, Allantoin,97-59-6,"Annex XI to the REACH Regulation provides for the waiver of additional animal testing in scenarios where adequate data exist, and further animal testing is not scientifically necessary to further the safety argument for the test substance. Given the preponderance of evidence, as well as the availability of a 2-year tumorigenicity study, it is scientifically unnecessary to generate additional mammalian data for Allantoin. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ec8a2f0-4b75-4e41-9e49-0eb310ba3886/documents/IUC5-f6ec0c5f-2b4a-4816-84d8-dc5b4d408756_e67dac0d-73a5-4464-9466-cb13e304dc81.html,,,,,, Allantoin,97-59-6,"In a reliable acute oral toxicity study, no mortality was recorded during the duration of the study. The LD50 was determined to be >5,000 mg/kg bw. No symptoms were noted during the observation period and no significant, treatment-related body weight changes were observed during the duration of the study. No abnormalities were detected upon gross examination of the principal organs of animals euthanized at the end of study. In a study reported in the European Agency for the Evaluation of Medicinal Products summary report on Allantoin, the dermal LD50 in rats is more than or equal to 5,000 mg/kg bw. No data are available via the inhalation route of exposure. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ec8a2f0-4b75-4e41-9e49-0eb310ba3886/documents/IUC5-2a594222-6190-4c3c-a4b2-707e25eaffd0_e67dac0d-73a5-4464-9466-cb13e304dc81.html,,,,,, Allantoin,97-59-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ec8a2f0-4b75-4e41-9e49-0eb310ba3886/documents/IUC5-2a594222-6190-4c3c-a4b2-707e25eaffd0_e67dac0d-73a5-4464-9466-cb13e304dc81.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Allantoin,97-59-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ec8a2f0-4b75-4e41-9e49-0eb310ba3886/documents/IUC5-2a594222-6190-4c3c-a4b2-707e25eaffd0_e67dac0d-73a5-4464-9466-cb13e304dc81.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Allyl butyrate,2051-78-7," Chronic oral toxicity study was performed by P. M. JENNER et.al (Food Cosmet. Tex 1964.) to determine the oral toxic nature of Allyl butyrate IUPAC : 2-Propen-1-yl butanoate (2051-78-7). Repeated toxicity study forAllyl butyratein male and femaleOsborne-Mendel rats was observed when they were exposed in a concentration of 50 and 90 mg/kg for 17 and 18 week respectively by oral (gavage). Rough and granular surface, firm consistency, nutmeg appearance was observed in liver at 90 mg/kg/day. At 90 mg/kg/day slight to moderate bile duct proliferation and fibrosis with pseudolobule formation .Necrosis with polymorph nuclear infiltration and swollen, foamy liver in 2-8 rats was observed. At 50 mg/kg/day slight to marked prebrochial lymphocyte infilteration was examined in treated group compare to controls. No effect was observed in liver at 50 mg/kg/day. As no significant change were observed on the clinical sign and gross pathology of other organ Therefore NOAEL was found to be 50 mg/kg/day for Allyl butyrate for chronic study. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/138a4631-48af-40c4-b26a-99dd149df721/documents/558da790-afa1-47b1-95f1-e873c327a9a3_d1b01b61-7513-4a3d-8376-622461a27c63.html,,,,,, Allyl butyrate,2051-78-7, Acute oral toxicity: LD50 was considered to be 250 mg/kg bw (216-290) when Osborne-Mendel male and female rat was treated with Allyl butyrate orally. Acute dermal toxicity: LD50 was considered to be 530 mg/kg bw when rabbits was treated with Allyl butyrate dermally. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/138a4631-48af-40c4-b26a-99dd149df721/documents/d7ac6c34-e4ae-4c43-9d68-a4cd3586480b_d1b01b61-7513-4a3d-8376-622461a27c63.html,,,,,, Allyl butyrate,2051-78-7,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/138a4631-48af-40c4-b26a-99dd149df721/documents/d7ac6c34-e4ae-4c43-9d68-a4cd3586480b_d1b01b61-7513-4a3d-8376-622461a27c63.html,,oral,LD50,250 mg/kg bw,adverse effect observed, Allyl butyrate,2051-78-7,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/138a4631-48af-40c4-b26a-99dd149df721/documents/d7ac6c34-e4ae-4c43-9d68-a4cd3586480b_d1b01b61-7513-4a3d-8376-622461a27c63.html,,dermal,LD50,530 mg/kg bw,adverse effect observed, Allyl hexanoate,123-68-2,The NOAEL for oral (feeding) repeated dose toxicity was >214 mg/kg bw/day in a chronic study in the rat. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbe012a8-2097-4c9b-94b4-9e034811ae9d/documents/IUC5-0361b63b-9528-4fc5-a13a-75ca9fab1f28_a6406972-2716-4aaf-a248-9576d7b25fed.html,,,,,, Allyl hexanoate,123-68-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbe012a8-2097-4c9b-94b4-9e034811ae9d/documents/IUC5-0361b63b-9528-4fc5-a13a-75ca9fab1f28_a6406972-2716-4aaf-a248-9576d7b25fed.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,214 mg/kg bw/day,,rat Allyl hexanoate,123-68-2,Oral: LD50 = 218 mg/kg body weight leading to classification into CLP Acute Toxicity Hazard Category 3Dermal: LD50 = 820 mg/kg body weight leading to classification into CLP Acute Toxicity Category 3Inhalation: no information available ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbe012a8-2097-4c9b-94b4-9e034811ae9d/documents/IUC5-877e5215-8207-455c-9040-dc025098a545_a6406972-2716-4aaf-a248-9576d7b25fed.html,,,,,, Allyl hexanoate,123-68-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbe012a8-2097-4c9b-94b4-9e034811ae9d/documents/IUC5-877e5215-8207-455c-9040-dc025098a545_a6406972-2716-4aaf-a248-9576d7b25fed.html,,oral,LD50,218 mg/kg bw,adverse effect observed, Allyl hexanoate,123-68-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbe012a8-2097-4c9b-94b4-9e034811ae9d/documents/IUC5-877e5215-8207-455c-9040-dc025098a545_a6406972-2716-4aaf-a248-9576d7b25fed.html,,dermal,LD50,820 mg/kg bw,adverse effect observed, Allyl hexanoate,123-68-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbe012a8-2097-4c9b-94b4-9e034811ae9d/documents/IUC5-877e5215-8207-455c-9040-dc025098a545_a6406972-2716-4aaf-a248-9576d7b25fed.html,,inhalation,LC50,792 mg/m3,adverse effect observed, Allyl (cyclohexyloxy)acetate,68901-15-5,"In a subchronic feeding study according to OECD guideline 408 in rats, the no observed adverse effect level (NOAEL) of the test substance is considered to be 0.1%, corresponding to 67.6 mg/kg bw/day (males) and 75.7 mg/kg bw/day (females).    In a supporting study (28-day feeding study in rats, according to OECD guideline 407), the NOAEL of the test substance was 0.03%, corresponding to 32.8 mg/kg bw/day (males) and 32.2 mg/kg bw/day (females) under the conditions of this study. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.6, of Regulation (EC) No 1907/2006. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f21a8b40-ff9c-4217-9cb1-0c19657a3ef1/documents/393fb72b-9738-4ea8-afb9-58729f144449_36d88550-2575-4f78-822c-442c854e5264.html,,,,,, Allyl (cyclohexyloxy)acetate,68901-15-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f21a8b40-ff9c-4217-9cb1-0c19657a3ef1/documents/393fb72b-9738-4ea8-afb9-58729f144449_36d88550-2575-4f78-822c-442c854e5264.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,67.6 mg/kg bw/day,,rat Allyl (cyclohexyloxy)acetate,68901-15-5,"Oral (equivalent to OECD 401), rat: LD50 = 620.42 mg/kg bwDermal (OECD 402), rat: LD50 > 2000 mg/kg bw (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f21a8b40-ff9c-4217-9cb1-0c19657a3ef1/documents/IUC5-b37c1e23-4f5e-4c4a-b993-62bbe470fbdb_36d88550-2575-4f78-822c-442c854e5264.html,,,,,, Allyl (cyclohexyloxy)acetate,68901-15-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f21a8b40-ff9c-4217-9cb1-0c19657a3ef1/documents/IUC5-b37c1e23-4f5e-4c4a-b993-62bbe470fbdb_36d88550-2575-4f78-822c-442c854e5264.html,,oral,LD50,620.42 mg/kg bw,adverse effect observed, Allyl 3-cyclohexylpropionate,2705-87-5,"The NOAEL for oral repeated dose toxicity was >214 mg/kg bw/day in a chronic study in the rat. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Pre-GLP, pre-OECD TG study, but with sufficient detail in documentation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb7ef747-f761-42b3-a494-998d6df86e12/documents/IUC5-50644e4f-92a7-4f84-ad23-bc00acea1d8d_38e568eb-f8b1-4774-89f5-e9ad57c55474.html,,,,,, Allyl 3-cyclohexylpropionate,2705-87-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb7ef747-f761-42b3-a494-998d6df86e12/documents/IUC5-50644e4f-92a7-4f84-ad23-bc00acea1d8d_38e568eb-f8b1-4774-89f5-e9ad57c55474.html,Chronic toxicity – systemic effects,oral,NOAEL,214 mg/kg bw/day,,rat Allyl 3-cyclohexylpropionate,2705-87-5,"The substance is acutely toxic via the oral and dermal route and needs to be classified according to CLP. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The two available studies follow principles that are generally similar to those of OECD TG 401 and are reliable with restrictions. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): One study is available, which is reliable with restrictions ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb7ef747-f761-42b3-a494-998d6df86e12/documents/IUC5-d782736a-604c-4670-8a7c-c1835896dea7_38e568eb-f8b1-4774-89f5-e9ad57c55474.html,,,,,, Allyl 3-cyclohexylpropionate,2705-87-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb7ef747-f761-42b3-a494-998d6df86e12/documents/IUC5-d782736a-604c-4670-8a7c-c1835896dea7_38e568eb-f8b1-4774-89f5-e9ad57c55474.html,,oral,LD50,380 mg/kg bw,adverse effect observed, Allyl 3-cyclohexylpropionate,2705-87-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb7ef747-f761-42b3-a494-998d6df86e12/documents/IUC5-d782736a-604c-4670-8a7c-c1835896dea7_38e568eb-f8b1-4774-89f5-e9ad57c55474.html,,dermal,LD50,"1,600 mg/kg bw",adverse effect observed, Allyl heptanoate,142-19-8,"Oral (OECD 408), rat: NOAEL = 84.25 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/94dea9ec-b624-464d-b992-afa72a660c2b/documents/IUC5-cc46ed33-3e21-4482-93f7-501927ff422b_98538d33-59db-480f-85d5-524a83a9aadc.html,,,,,, Allyl heptanoate,142-19-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/94dea9ec-b624-464d-b992-afa72a660c2b/documents/IUC5-cc46ed33-3e21-4482-93f7-501927ff422b_98538d33-59db-480f-85d5-524a83a9aadc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,84.25 mg/kg bw/day,,rat Allyl heptanoate,142-19-8,Oral: LD50 = 238 mg/kg bw allyl heptanoate (value derived from read across compound allyl hexanoate LD50 = 218 mg/kg bw)Dermal: LD50 = 810 mg/kg bw allyl heptanoate ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94dea9ec-b624-464d-b992-afa72a660c2b/documents/IUC5-1d3d170f-fed5-401a-98e2-59c6cc7abe6c_98538d33-59db-480f-85d5-524a83a9aadc.html,,,,,, Allyl heptanoate,142-19-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94dea9ec-b624-464d-b992-afa72a660c2b/documents/IUC5-1d3d170f-fed5-401a-98e2-59c6cc7abe6c_98538d33-59db-480f-85d5-524a83a9aadc.html,,oral,LD50,238 mg/kg bw,adverse effect observed, Allyl heptanoate,142-19-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94dea9ec-b624-464d-b992-afa72a660c2b/documents/IUC5-1d3d170f-fed5-401a-98e2-59c6cc7abe6c_98538d33-59db-480f-85d5-524a83a9aadc.html,,dermal,LD50,810 mg/kg bw,adverse effect observed, Allyl methacrylate,96-05-9," - oral, rat, subacute: NOAEL = 15 mg/kg bw, LOAEL = 60 mg/kg bw (according to OECD 422) - dermal, subacute (28 days), rabbit: NOAEL: 25 mg/kg/d ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/228aff67-1e0e-4f64-bde5-0d2e906e49a4/documents/IUC5-1d944222-6812-4a44-80b1-2bfcf1af502c_2f5511a4-1fa6-4af2-85ae-543cecff88ed.html,,,,,, Allyl methacrylate,96-05-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/228aff67-1e0e-4f64-bde5-0d2e906e49a4/documents/IUC5-1d944222-6812-4a44-80b1-2bfcf1af502c_2f5511a4-1fa6-4af2-85ae-543cecff88ed.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat Allyl methacrylate,96-05-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/228aff67-1e0e-4f64-bde5-0d2e906e49a4/documents/IUC5-1d944222-6812-4a44-80b1-2bfcf1af502c_2f5511a4-1fa6-4af2-85ae-543cecff88ed.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,25 mg/kg bw/day,,rabbit Allyl methacrylate,96-05-9,"Acute oral toxicity:- oral: rat (males): LD50 = 470 mg/kg- inhalative, rat (males/females): LC50 = 1.47 mg/L (according to EU, OECD and EPA OTS 798.1150 (Acute inhalation toxicity))- dermal, rat (males): LD50 = 467 mg/kg ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/228aff67-1e0e-4f64-bde5-0d2e906e49a4/documents/IUC5-8d3025d7-09e3-477a-a942-00d09e8c2f56_2f5511a4-1fa6-4af2-85ae-543cecff88ed.html,,,,,, Allyl methacrylate,96-05-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/228aff67-1e0e-4f64-bde5-0d2e906e49a4/documents/IUC5-8d3025d7-09e3-477a-a942-00d09e8c2f56_2f5511a4-1fa6-4af2-85ae-543cecff88ed.html,,oral,LD50,470 mg/kg bw,adverse effect observed, Allyl methacrylate,96-05-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/228aff67-1e0e-4f64-bde5-0d2e906e49a4/documents/IUC5-8d3025d7-09e3-477a-a942-00d09e8c2f56_2f5511a4-1fa6-4af2-85ae-543cecff88ed.html,,dermal,LD50,467 mg/kg bw,adverse effect observed, Allyl methacrylate,96-05-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/228aff67-1e0e-4f64-bde5-0d2e906e49a4/documents/IUC5-8d3025d7-09e3-477a-a942-00d09e8c2f56_2f5511a4-1fa6-4af2-85ae-543cecff88ed.html,,inhalation,LC50,"1,470 mg/m3",adverse effect observed, Allyl phenoxyacetate,7493-74-5," Oral (OECD 422), rat: NOAEL 50 mg/kg bw/day in males and females ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f3c1bfe-151f-4382-8fff-61e00c18ba91/documents/8d6e1d35-0f2b-44ee-801b-a3e35d61a850_7b1f0936-b54a-48f6-8d86-8bb21b15fc4f.html,,,,,, Allyl phenoxyacetate,7493-74-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f3c1bfe-151f-4382-8fff-61e00c18ba91/documents/8d6e1d35-0f2b-44ee-801b-a3e35d61a850_7b1f0936-b54a-48f6-8d86-8bb21b15fc4f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Allyl phenoxyacetate,7493-74-5,"Oral (OECD 401), rat: LD50 = 835 mg/kg bwDermal (OECD 402), rat: LD50 > 2000 mg/kg bw (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f3c1bfe-151f-4382-8fff-61e00c18ba91/documents/IUC5-2e18cc6d-9553-4894-8a7b-60d991b625b9_7b1f0936-b54a-48f6-8d86-8bb21b15fc4f.html,,,,,, Allyl phenoxyacetate,7493-74-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f3c1bfe-151f-4382-8fff-61e00c18ba91/documents/IUC5-2e18cc6d-9553-4894-8a7b-60d991b625b9_7b1f0936-b54a-48f6-8d86-8bb21b15fc4f.html,,oral,LD50,835 mg/kg bw,adverse effect observed, Allyl propionate,2408-20-0," Subacute repeated dose oral toxicity study was performed to determine the oral toxic nature of Allyl propionate upon repeated exposure for 13 weeks. The study was performed using rats. The test chemical was mixed with feed at dose levels of 18 mg/Kg bw and fed to rats for 13 weeks. During the study, the animals were observed for hepatotoxicity. No signs of hepatic toxicity were noted at the mentioned dose level. Based on the data available, the No Observed Adverse Effect Level (NOAEL) for Allyl propionate is considered to be 18 mg/Kg bw/day. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/716db697-4005-413e-8d79-dbe3305916d2/documents/d2148092-78fc-4a8d-94ff-cbb82e84d9bd_b967215d-c9b1-4de5-91d8-37724bffc5d8.html,,,,,, Allyl propionate,2408-20-0,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/716db697-4005-413e-8d79-dbe3305916d2/documents/d2148092-78fc-4a8d-94ff-cbb82e84d9bd_b967215d-c9b1-4de5-91d8-37724bffc5d8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,18 mg/kg bw/day,,rat Allyl propionate,2408-20-0," Acute oral toxicity LD50 was estimated to be 294.153mg/kg bw, when male and female Sprague-Dawley rats were exposed with 2-Propenyl Propanoate (2408-20-0) orally. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/716db697-4005-413e-8d79-dbe3305916d2/documents/432e6514-aab7-4e8b-972a-64957e4bf7f4_b967215d-c9b1-4de5-91d8-37724bffc5d8.html,,,,,, Allyl propionate,2408-20-0,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/716db697-4005-413e-8d79-dbe3305916d2/documents/432e6514-aab7-4e8b-972a-64957e4bf7f4_b967215d-c9b1-4de5-91d8-37724bffc5d8.html,,oral,LD50,294.153 mg/kg bw,no adverse effect observed, "4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one",127-41-3,"Repeated dose toxicity: Oral OECD 408 study (GLP) with a source substance: The no-observed-effect-level (NOEL) under the conditions of the present study was 100 ppm for both sexes (about 7 and 8 mg/kg bw/day for males and females) based on adaptive liver effects in both sexes and minor urine findings in males at 1000 ppm which correspond to a dosage of 72 and 83 mg/kg bw/day for males and females (no-observed-adverse-effect-level, NOAEL). The lowest-observed-adverse-effect-level (LOAEL) was found at 10 000 ppm (720 and 801 mg/kg bw/day for males and females) due to liver, kidney and thyroid findings in both sexes. OECD 408 study (GLP) with a source substance: The male rat NOAEL was considered at 5 mg/kg bw/day based on histopathological changes in kidneys at 30 and 500 mg/kg bw/day (which were not considered relevant for humans) and the female rat NOAEL was considered at 500 mg/kg bw/day. 17-week study with a source substance : The rat NOAEL was considered at 10000 ppm for both genders. Swelling of parenchymal cells in the liver was reported at all dose levels (very slight at 1000 ppm; slight at 2500 ppm; and slight to moderate at 10000 ppm). This effect was most likely an adaptive response to treatment due to increased metabolic demand of the liver.   Repeated dose toxicity: Inhalation 4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one (CAS no 127-41-3)has very low vapor pressure of3.61 Pa (0.0271 mm Hg), so the potential for the generation of inhalable vapours is very low, also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route of exposure was considered for waiver.   Repeated dose Toxicity: Dermal The acute toxicity value for 4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one ( 127-41-3 ) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, used predominantly as a fragrance ingredient in cosmetic products especially in perfumery as well as in non-cosmetic products such as household cleaners and detergents. Its use worldwide is in the region of 100–1000 metric tonnes per annum. The maximum skin level that results from the use of alpha ionone in formulae that go into fine fragrances has been reported to be 1% (Belsito et al, 2007), assuming the dermal systemic exposure in cosmetic products to be 0.0512 mg/Kg/day. Since the exposure concentration related to the chemical is very less, hence the end point is considered for waiver. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80dfa5ce-6bf9-46ba-9eda-1b55e94c4ba6/documents/d6a8c8c9-d3ab-4750-8c03-f5a7747544ca_94553082-33e8-43c4-a491-b89b91e71faf.html,,,,,, "4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one",127-41-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80dfa5ce-6bf9-46ba-9eda-1b55e94c4ba6/documents/d6a8c8c9-d3ab-4750-8c03-f5a7747544ca_94553082-33e8-43c4-a491-b89b91e71faf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,72 mg/kg bw/day,,rat "4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one",127-41-3,"Acute oral toxicity:    The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is 4590 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.   Acute Inhalation Toxicity:   The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 3.61 Pa (0.0271 mm Hg). Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity:   The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The LD50 value is >5000 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80dfa5ce-6bf9-46ba-9eda-1b55e94c4ba6/documents/7274ca9f-4648-49bc-a415-07fe4743d8c9_94553082-33e8-43c4-a491-b89b91e71faf.html,,,,,, "4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one",127-41-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80dfa5ce-6bf9-46ba-9eda-1b55e94c4ba6/documents/7274ca9f-4648-49bc-a415-07fe4743d8c9_94553082-33e8-43c4-a491-b89b91e71faf.html,,oral,LD50,"4,590 mg/kg bw",no adverse effect observed, "4-(2,6,6-trimethylcyclohex-2-ene-1-yl)-but-3-ene-2-one",127-41-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80dfa5ce-6bf9-46ba-9eda-1b55e94c4ba6/documents/7274ca9f-4648-49bc-a415-07fe4743d8c9_94553082-33e8-43c4-a491-b89b91e71faf.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one",127-51-5," Repeated dose toxicity: oral The test substance was considered to have a NOAEL of 3.55 mg/kg/day in male rats and 4.10 mg/kg/day in female rats after 90-Days of feeding. The test chemical is not likely to classify as a toxicant upon repeated application by the oral route of exposure. Repeated dose toxicity: inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one, which is reported as 0.22 Pa, thus exposure to inhalable dust, mist and vapour of the chemical 3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one is highly unlikely. Also it is a fragrance ingredient found in a variety of consumer products, humans have the potential to be exposed to low but continuous levels, primarily via the dermal route. Therefore this study is considered for waiver. Repeated dose toxicity: dermal On the basis of the review of the kidney histopathology data and considering the dermal inflammation and infection in the rats, the results of this study are concluded to show a systemic NOAEL of topical alpha-isomethyl ionone of 50 mg/kg. The test chemical α- isomethylionone is not likely to classify as a toxicant upon repeated application by the dermal route of exposure. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7dcfa740-f8a1-43e8-bcdb-2d5dd178411d/documents/e4043c51-105b-4f1e-bd69-44eae10ab0d5_40ecb7e4-282e-4513-8034-9b7dc2f3e1cc.html,,,,,, "3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one",127-51-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7dcfa740-f8a1-43e8-bcdb-2d5dd178411d/documents/e4043c51-105b-4f1e-bd69-44eae10ab0d5_40ecb7e4-282e-4513-8034-9b7dc2f3e1cc.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,50 mg/kg bw/day,,rat "3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one",127-51-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7dcfa740-f8a1-43e8-bcdb-2d5dd178411d/documents/e4043c51-105b-4f1e-bd69-44eae10ab0d5_40ecb7e4-282e-4513-8034-9b7dc2f3e1cc.html,Chronic toxicity – systemic effects,oral,NOAEL,3.55 mg/kg bw/day,,rat "3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one",127-51-5," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is >5000 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.22 Pa (0.0016 mm Hg). Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The LD50 value is >5000 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7dcfa740-f8a1-43e8-bcdb-2d5dd178411d/documents/e3a375ec-0a3c-4895-b66f-e0c52ab281e1_40ecb7e4-282e-4513-8034-9b7dc2f3e1cc.html,,,,,, "3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one",127-51-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7dcfa740-f8a1-43e8-bcdb-2d5dd178411d/documents/e3a375ec-0a3c-4895-b66f-e0c52ab281e1_40ecb7e4-282e-4513-8034-9b7dc2f3e1cc.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3-methyl-4-(2,6,6-trimethyl-2-cyclohexen-1-yl)-3-buten-2-one",127-51-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7dcfa740-f8a1-43e8-bcdb-2d5dd178411d/documents/e3a375ec-0a3c-4895-b66f-e0c52ab281e1_40ecb7e4-282e-4513-8034-9b7dc2f3e1cc.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "(1α,2α,5α)-2,2,6-trimethylbicyclo[3.1.1]heptan-2-ol",4948-28-1,"In the key acute oral toxicity study in male and female rats, the LD50 was found to be 2050 mg/kg bw in male and females.   In a supporting acute oral toxicity study in male and female rats, all animals died at a single dose of 5000 mg/kg bw. The LD50 is thus <5000 mg/kg bw.   In an acute dermal toxicity study in male and female rabbits, all animals survived after a single dose of 5000 mg/kg bw. The LD50 is thus >5000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable with restrictions Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Reliable with restrictions ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2104a69-0dcd-4e51-af4c-872592bde3f5/documents/ddda0626-dc8c-4eb9-927f-bda54ec53677_42ff4f1d-a7f0-4f42-bea7-574bfdcda520.html,,,,,, "(1α,2α,5α)-2,2,6-trimethylbicyclo[3.1.1]heptan-2-ol",4948-28-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2104a69-0dcd-4e51-af4c-872592bde3f5/documents/ddda0626-dc8c-4eb9-927f-bda54ec53677_42ff4f1d-a7f0-4f42-bea7-574bfdcda520.html,,oral,LD50,"2,050 mg/kg bw",no adverse effect observed, "(1α,2α,5α)-2,2,6-trimethylbicyclo[3.1.1]heptan-2-ol",4948-28-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2104a69-0dcd-4e51-af4c-872592bde3f5/documents/ddda0626-dc8c-4eb9-927f-bda54ec53677_42ff4f1d-a7f0-4f42-bea7-574bfdcda520.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "p-mentha-1,3-diene",99-86-5," Weight of evidence and read-across approach: Some reliable experimental studies on repeated dose toxicity are available from the analogue substance d-limonene and thus a weight of evidence and read across approach was applied to fulfill this information requirement for alpha terpinene. There are subacute and subchronic studies in rats, mice and dogs. Signs of nephrotoxicity were observed in males of all the studies conducted with rats. The absence of any d-limonene-induced renal lesions in the studies with dogs and mice provides evidence that hydrocarbon induced nephropathy in the male rat is species- and sex-specific. Therefore, the male rat response to d-limonene may not be appropriate for assessing the potential risk of a similar nephrotoxic response in any other species, including humans. According to CLP annex I 3.9.2.8.1. (e), substance-induced species-specific mechanisms of toxicity, i.e. demonstrated with reasonable certainty to be not relevant for human health, shall not justify classification. When administered orally by gavage for at least 6 months, d-limonene induces some toxicological effects from 1000 mg/kg bw/d. At this dose level, following 90 days of exposure, d-limonene induces decreased bodyweight gain and clinical signs in mice. 180 days of exposure to d-limonene at this dose level decreased bodyweight gain and increased relative and absolute kidney weights of dogs (with protein casts in the renal tubules of females). Thus, the key value has been selected to be the LOAEL at 1000 mg/kg bw/d. The key study was then selected to be the 180-d toxicity study by oral route in dogs (Webb, 1990) for DNEL derivation since mammalian exposure is more relevant than rodent exposure regarding human health effect assessment. Moreover effects were seen in this study on the target organ of d-limonene, kidneys. Based on the weight of evidence and read-across approach, the key value for alpha terpinene is considered to be LOAEL = 1000 mg/kg bw from the 180-d dog study. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b93491ac-e53e-427d-affb-03abb899171c/documents/defe00db-8fd9-493c-a468-69e0e5732c40_bca89f83-4c62-42b1-9a7e-a6a4562b2588.html,,,,,, "p-mentha-1,3-diene",99-86-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b93491ac-e53e-427d-affb-03abb899171c/documents/defe00db-8fd9-493c-a468-69e0e5732c40_bca89f83-4c62-42b1-9a7e-a6a4562b2588.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,"1,000 mg/kg bw/day",,dog "p-mentha-1,3-diene",99-86-5," Acute oral toxicity. Key study: The key study (1973) on oral acute toxicity was conducted in rats using alpha terpinene. 10 rats per treatment were exposed to the following doses: 1.05, 1.31, 1.64, 2.05 and 5 g/kg. Rats were observed for 14 days.   No clinical findings and deaths occurred in the lowest tested dose (1.05 g/kg). Lethargy was observed on the day of dosing in rats dosed at 1.31, 1.64, 2.05 and 5 g/kg. The rats dosed at 2.05 and 5 g/kg exhibited loss of righting reflex and piloerection.   The exposure to the middle doses (1.31 and 1.64 g/kg) caused 40% of death. 80% of death animals were found at 2.05 g/kg within 10 days after a single exposure. The highest dose caused 100% of death after 24 hrs. (8 deaths) and 48 hrs (2 deaths), respectively.   Based on the results the LD50 was calculated to be 1.68 g/kg (1.46 - 1.90). Acute inhalation toxicity. Data waiving (study scientifically not necessary): According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route needs to be provided. The information is provided for dermal route. Acute dermal toxicity: Key study: Test method according to OECD 402, GLP study. The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in rats. 3 female Sprague-Dawley rats were tested for a exposure period of 24 h. Initially, a range finding study was conducted at a single dose of 2000 mg/kg bw in one animal. Based on the results of range finding two additional rats were tested at a dose of 2000 mg/kg bw. No mortality was observed. The body weight evolution of the animals remained normal during the study. Erythema was noted in treated animals (3/3) between days 1 and 7. This reaction was associated with dryness of the skin (3/3) between days 3 and 12 and scab (3/3) between days 3 and 8. The skin recovered a normal aspect at day 13. No other clinical signs were observed. The macroscopic examination of the animals at the end of the study did not reveal treatment related effects. . ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b93491ac-e53e-427d-affb-03abb899171c/documents/b9755a87-b090-495b-831f-8893675871d6_bca89f83-4c62-42b1-9a7e-a6a4562b2588.html,,,,,, "p-mentha-1,3-diene",99-86-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b93491ac-e53e-427d-affb-03abb899171c/documents/b9755a87-b090-495b-831f-8893675871d6_bca89f83-4c62-42b1-9a7e-a6a4562b2588.html,,oral,LD50,"1,680 mg/kg bw",adverse effect observed, "p-mentha-1,3-diene",99-86-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b93491ac-e53e-427d-affb-03abb899171c/documents/b9755a87-b090-495b-831f-8893675871d6_bca89f83-4c62-42b1-9a7e-a6a4562b2588.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Aluminium oxide,1344-28-1," chronic toxicity: oral, rat: NOAEL: 322.5 mg/kg bw/day as aluminium citrate (equivalent to 113.36 mg Al oxide/kg bw/day) inhalation, rat: NOAEC >= 75 mg/m³ as aluminium oxide ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/659b1eee-02c5-4ca7-8577-f4cf04ee8a98/documents/9cecacc4-9f38-4087-9e0e-15604bbe1631_2df8153c-8ee6-4d0b-af81-c6546e5dabbc.html,,,,,, Aluminium oxide,1344-28-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/659b1eee-02c5-4ca7-8577-f4cf04ee8a98/documents/9cecacc4-9f38-4087-9e0e-15604bbe1631_2df8153c-8ee6-4d0b-af81-c6546e5dabbc.html,Chronic toxicity – systemic effects,oral,NOAEL,113 mg/kg bw/day,,rat Aluminium oxide,1344-28-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/659b1eee-02c5-4ca7-8577-f4cf04ee8a98/documents/9cecacc4-9f38-4087-9e0e-15604bbe1631_2df8153c-8ee6-4d0b-af81-c6546e5dabbc.html,Repeated dose toxicity – local effects,inhalation,NOAEC,75 mg/m3,no adverse effect observed,rat Aluminium oxide,1344-28-1,Oral: LD50 (rat) > 2000 mg/kg bwInhalation: LC50(rat) > 2.3 mg/L ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/659b1eee-02c5-4ca7-8577-f4cf04ee8a98/documents/9daef7ff-89dd-46b8-9dde-963f66fd3871_2df8153c-8ee6-4d0b-af81-c6546e5dabbc.html,,,,,, Aluminium tribenzoate,555-32-8," No repeated dose toxicity data are available for aluminium tribenzoate, the endpoint is filled by read across (rationale is attached in section 13). There are several publications and evaluations available for both the benzoate and aluminium ion. Based on the results of a feeding study with benzoic acid over 4 generations (chosen as key study), the NOAEL was established to be at least 1% in feed, which correlates to approximately 430 mg aluminium tribenzoate/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/441e9026-7886-4463-a44d-16224a39db00/documents/dea4fccf-310e-475d-a1a7-be7c454d32f5_7eab4c26-5108-4f25-b65a-2387924454a9.html,,,,,, Aluminium tribenzoate,555-32-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/441e9026-7886-4463-a44d-16224a39db00/documents/dea4fccf-310e-475d-a1a7-be7c454d32f5_7eab4c26-5108-4f25-b65a-2387924454a9.html,Chronic toxicity – systemic effects,oral,NOAEL,430 mg/kg bw/day,,rat Aluminium tribenzoate,555-32-8," An acute oral toxicity study with rats is available, performed according to OECD/EC test guidelines and GLP principles. The results demonstrate that aluminium tribenzoate has an acute oral LD50 >2000 mg/kg bw. Aluminium tribenzoate was concluded not to have acute inalation toxicity, based on data on substance analogues. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/441e9026-7886-4463-a44d-16224a39db00/documents/fb08903f-11c6-44e8-a051-8939c3a206b1_7eab4c26-5108-4f25-b65a-2387924454a9.html,,,,,, Aluminium tri-sec-butanolate,2269-22-9," Upon contact with water or moisture (e.g. within mucous membranes) aluminium tri-sec-butanolate hydrolyses immediately to butan-2-ol and aluminium 3+ cations (as hydroxide and oxyhydroxide). Hence, toxicity is determined by the toxicity of these two species Male Sprague-Dawley rats were exposed to aluminium hydroxide with diet at 302 mg Al/kg body weight for 28 days. During the entire experimental period, no mortality was reported and no treatment-related clinical signs were observed. There were no significant differences in body weight, food and water consumption and haematological parameters compared to controls that received basal diet. There were no other significant group differences in organ weights and microscopic changes. Aluminium concentrations in femur samples were <1 ppm (quantifiable in all 5 samples from animals treated with Al (OH)3 and in 2 samples from the control animals).The results of this study provide no evidence for significant deposition of Al in the bone and for toxicity of Al hydroxide during 28-day dietary administration at daily doses up to ≈300 mg Al/kg body weight. (Hicks 1987) Sodium aluminium phosphate was administered to beagle dogs with diet at concentrations 0% (control), 0.3%, 1.0% and 3.0% for 6 months. There were no significant group differences in body weight throughout the experiment. Reductions in mean body weight occurred in all groups during week 27, which the authors attributed to “pre-termination tests and increased handling by technicians.” No treatment-related clinical signs and no ocular changes in any of the animals were observed. In most weeks, treated male and female dogs consumed less food than control dogs. In male animals, none of the differences in mean food consumption values were statistically significant. In females, significant reductions occurred “sporadically”. The authors did not consider these differences in food consumption as “toxicologically significant”, a conclusion that was supported by the absence of corresponding reduction in body weights. The treatment did not have any effect on haematological and blood biochemistry parameters, urinalysis results and results of analysis for occult blood in faeces. There were no significant differences in mean organ weights between the treated groups and the control group. Gross pathology and histopathology findings were in the “normal range of variations for dogs of this strain and age”; no treatment-related lesions were observed. The results of this study provide no evidence for toxicity of acidic form of sodium aluminium phosphate during 6-month administration at concentrations up to 3% in the diet (30 mg/kg bw as Al) (Katz 1984). In a poorly documented study Aluminium (as Aluminium citrate) in drinking water was shown to affect erythropoiesis in rats with normal renal function (Vittori 1999). Although inhalation exposure may not be too relevant for aluminium tri-sec-butylate, hydrolysis forms 2-butanol having a high vapour pressure and exposure to 2-butanol, when handling aluminium tri-sec-butylate, is considered relevant. 2-butanol itself has not been investigated in a subchronic inhalation study but its primary metabolite methyl ethyl ketone using rats as test animals and resulting in a NOAEC of 2518 ppm, 7425 mg/m3 (mid dose tested). Main effects at the high dose in this study were reduced body weight and reduced organ weight with liver and kidneys being target organs. Hence, it can be concluded, that only limited systemic or local effects at elevated concentrations from 2-butanol inhalation exposure is to be expected. Inhalation toxicity studies on aluminium/aluminium oxide dust are of limited relevance, as aluminium tri-sec-butylate upon contact with moist air would hydrolyse and hardly any aluminium dust may be formed this way but can be considered as a worst case. In sub-chronic studies performed with rats (6 month) guinea pigs (12 month) and hamsters (6 month) by Gross et al. (1973) NOAEC values of 70 mg/m3, 30 mg/m3 and 70 mg/m3 air respectively were found. In conclusion of a weight of evidence approach it can be summarized, that neither aluminium3+ nor 2-butanol caused significant effect in subacute and subchronic studies. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c432a191-7305-4590-8456-b7df1fe452df/documents/9a601620-292f-4836-af7a-f1822dc1a192_3680d175-0b94-4d7e-b3f5-0f09cb857957.html,,,,,, Aluminium tri-sec-butanolate,2269-22-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c432a191-7305-4590-8456-b7df1fe452df/documents/9a601620-292f-4836-af7a-f1822dc1a192_3680d175-0b94-4d7e-b3f5-0f09cb857957.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Aluminium tri-sec-butanolate,2269-22-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c432a191-7305-4590-8456-b7df1fe452df/documents/9a601620-292f-4836-af7a-f1822dc1a192_3680d175-0b94-4d7e-b3f5-0f09cb857957.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"7,425 mg/m3",,rat Aluminium tri-sec-butanolate,2269-22-9," Upon contact with water or moisture (e.g. within mucous membranes) aluminium tri-sec-butanolate hydrolyses immediately to butan-2-ol and aluminium 3+ cations (as hydroxide and oxyhydroxide). Hence, toxicity is determined by the toxicity of these two species. The acute oral toxicity of butan-2-ol in rat as expressed as LD50 is 2193 mg/kg bw (Price 1986). For aluminium nitrate and aluminium tri-isopropanolate oral LD50 values of 4280 mg/kg and 11300 mg/kg bw are reported (Smyth 1969). For acute inhalation toxicity no LC50 could be derived for butan-2-ol and a LC50 of 888 mg/m3 for aluminium flakes were derived (Reynolds 1986). The dermal LD50 for butan-2-ol in rats is >2000 mg/kg bw (Price 1986). Butan-2-ol showed local irritant effects on the respiratory system and transient effects on the CNS (drowsiness and dizziness) and is therefore classified as STOT SE 3, H335/H336 (according to Annex VI of Regulation EC 1272/2008). Aluminium species (hydroxide or oxide) that may be formed during hydrolysis are not classified for acute toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c432a191-7305-4590-8456-b7df1fe452df/documents/211d24bd-2b2f-4eba-824c-9ecd1ef5b124_3680d175-0b94-4d7e-b3f5-0f09cb857957.html,,,,,, Aluminium tri-sec-butanolate,2269-22-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c432a191-7305-4590-8456-b7df1fe452df/documents/211d24bd-2b2f-4eba-824c-9ecd1ef5b124_3680d175-0b94-4d7e-b3f5-0f09cb857957.html,,oral,LD50,"2,193 mg/kg bw",no adverse effect observed, Aluminium tri-sec-butanolate,2269-22-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c432a191-7305-4590-8456-b7df1fe452df/documents/211d24bd-2b2f-4eba-824c-9ecd1ef5b124_3680d175-0b94-4d7e-b3f5-0f09cb857957.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Silicic acid, aluminum calcium sodium salt",1344-01-0,"A read-across was made from the registered substance to the results of testing on the similar substance silicic acid, aluminium, sodium salt. The test substance was found to be non-toxic to rats and mice via repeated oral, dietary exposure. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5bd9c48e-221d-49de-bafe-a39dcc25d31b/documents/IUC5-82170d11-89de-469a-9826-e3e02769373d_f2ff7e47-3581-4d9a-b691-1b0ea0e4f1be.html,,,,,, "Silicic acid, aluminum calcium sodium salt",1344-01-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5bd9c48e-221d-49de-bafe-a39dcc25d31b/documents/IUC5-82170d11-89de-469a-9826-e3e02769373d_f2ff7e47-3581-4d9a-b691-1b0ea0e4f1be.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"4,750 mg/kg bw/day",,rat "Silicic acid, aluminum calcium sodium salt",1344-01-0,"The substance is not considered acutely toxic via the oral, inhalation or dermal routes. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5bd9c48e-221d-49de-bafe-a39dcc25d31b/documents/IUC5-f75d6f7d-a851-426f-b7da-302ee0fa0489_f2ff7e47-3581-4d9a-b691-1b0ea0e4f1be.html,,,,,, "Silicic acid, aluminum calcium sodium salt",1344-01-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5bd9c48e-221d-49de-bafe-a39dcc25d31b/documents/IUC5-f75d6f7d-a851-426f-b7da-302ee0fa0489_f2ff7e47-3581-4d9a-b691-1b0ea0e4f1be.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Silicic acid, aluminum calcium sodium salt",1344-01-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5bd9c48e-221d-49de-bafe-a39dcc25d31b/documents/IUC5-f75d6f7d-a851-426f-b7da-302ee0fa0489_f2ff7e47-3581-4d9a-b691-1b0ea0e4f1be.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Aluminium chloride,7446-70-0,"Oral: read-across to CAS 1327-41-9, according to OECD guideline 422, GLP-compliant, rat, NOAEL for systemic toxicity: 1000 mg/kg bw/day, NOAEL for local toxicity: 200 mg/kg bw/day Inhalation: according to OECD guideline 413, GLP-compliant, rat, NOAEC for systemic toxicity: 0.1 mg/m3 air, LOAEC for local toxicity: 0.1 mg/m3 air ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe4172dc-2e36-448d-ac45-3497980b2412/documents/ad7175da-3faa-47cb-b89c-46e106f0925c_e768058e-1566-4517-942e-bb60b5a0c141.html,,,,,, Aluminium chloride,7446-70-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe4172dc-2e36-448d-ac45-3497980b2412/documents/ad7175da-3faa-47cb-b89c-46e106f0925c_e768058e-1566-4517-942e-bb60b5a0c141.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Aluminium chloride,7446-70-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe4172dc-2e36-448d-ac45-3497980b2412/documents/ad7175da-3faa-47cb-b89c-46e106f0925c_e768058e-1566-4517-942e-bb60b5a0c141.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.1 mg/m3,,rat Aluminium chloride,7446-70-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe4172dc-2e36-448d-ac45-3497980b2412/documents/ad7175da-3faa-47cb-b89c-46e106f0925c_e768058e-1566-4517-942e-bb60b5a0c141.html,Repeated dose toxicity – local effects,inhalation,LOAEC,0.1 mg/m3,adverse effect observed,rat Aluminium chloride,7446-70-0,"The test substance is classified as corrosive to the skin (Cat 1B). Therefore, acute toxicity testing is considered unwarranted and no studies are available concerning acute inhalation or acute dermal toxicity of the test substance. In a supporting study in Wistar rats, the LD50 for males has been found to be 3450 mg/kg bw and the LD50 for females has been found to be 3470 mg/kg bw after oral exposure to the test substance. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe4172dc-2e36-448d-ac45-3497980b2412/documents/IUC5-7a8cd289-616f-434b-a0e9-86d89d85954f_e768058e-1566-4517-942e-bb60b5a0c141.html,,,,,, Aluminium chloride,7446-70-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe4172dc-2e36-448d-ac45-3497980b2412/documents/IUC5-7a8cd289-616f-434b-a0e9-86d89d85954f_e768058e-1566-4517-942e-bb60b5a0c141.html,,oral,LD50,"3,450 mg/kg bw",no adverse effect observed, Dialuminium chloride pentahydroxide,12042-91-0," Repeated dose toxicity, oral route: NOAEL = 1000 mg/kg bw/d (analogue substance, OECD 422, Key, rel.2), corresponding to a ca. NOAEL of 290 mg/kg bw/day for Dialuminium chloride penntahydroxide Repeated dose toxicity, inhalation : LOAEL = 15.3 mg/m3 (OECD 413, Key, rel.2) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e5af026-138f-493e-993c-95c3cc89a475/documents/53efcd8a-83b2-4699-a4bd-ca78ac9894ae_dac37342-535d-4377-9a04-7c75e73441db.html,,,,,, Dialuminium chloride pentahydroxide,12042-91-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e5af026-138f-493e-993c-95c3cc89a475/documents/53efcd8a-83b2-4699-a4bd-ca78ac9894ae_dac37342-535d-4377-9a04-7c75e73441db.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,290 mg/kg bw/day,,rat Dialuminium chloride pentahydroxide,12042-91-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e5af026-138f-493e-993c-95c3cc89a475/documents/53efcd8a-83b2-4699-a4bd-ca78ac9894ae_dac37342-535d-4377-9a04-7c75e73441db.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,15.3 mg/m3,,rat Dialuminium chloride pentahydroxide,12042-91-0," Acute Oral toxicity: - LD50 = 9187 mg/kg bw (OECD 401, Key, rel.2) - LD50 > 2000 mg/kg bw (OECD 401, Supp, rel.2) Acute dermal toxicity: LD50 > 2000 mg/kg bw (OECD 402, Key, rel.2) Acute inhalation toxicity: Based on the particle size the inhalatory toxicity test with the solid test article was not possible. Instead an aqueous suspension in deionised water was tested. 1 < LC50(aqueous suspension) < 5 mg/L (OECD 403, GLP, Supp, rel.4). This result cannot be used for the assessment of the solid substance. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e5af026-138f-493e-993c-95c3cc89a475/documents/IUC5-ee6e730b-e55b-4e7f-b63e-9d0a21189081_dac37342-535d-4377-9a04-7c75e73441db.html,,,,,, Dialuminium chloride pentahydroxide,12042-91-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e5af026-138f-493e-993c-95c3cc89a475/documents/IUC5-ee6e730b-e55b-4e7f-b63e-9d0a21189081_dac37342-535d-4377-9a04-7c75e73441db.html,,oral,LD50,"9,187 mg/kg bw",no adverse effect observed, Dialuminium chloride pentahydroxide,12042-91-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e5af026-138f-493e-993c-95c3cc89a475/documents/IUC5-ee6e730b-e55b-4e7f-b63e-9d0a21189081_dac37342-535d-4377-9a04-7c75e73441db.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Bis(acetato-O)hydroxyaluminium,142-03-0," A NOAEL of 30 mg Al/kg bw/d has been determined in a chronic repeated dose toxicity study for the source substance (reference [7.5.1 -1]). Considering the differing molecular weights of source and target substance, a NOAEL of 180 mg/kg bw/d was determined for aluminium acetate (reference [7.5.1 -2]). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9cbf58f5-9431-46e2-b845-6b4c370f2fe9/documents/99d0d272-1e1a-40e9-a420-8a3258e62ac8_a12a7e06-a81d-4e09-94bd-420e44628321.html,,,,,, Bis(acetato-O)hydroxyaluminium,142-03-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9cbf58f5-9431-46e2-b845-6b4c370f2fe9/documents/99d0d272-1e1a-40e9-a420-8a3258e62ac8_a12a7e06-a81d-4e09-94bd-420e44628321.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,180 mg/kg bw/day,,rat Bis(acetato-O)hydroxyaluminium,142-03-0," Acute oral toxicity Based on the results of the OECD 423 study, the test item has no acute toxic potential, and the LD50 value is higher than 2000 mg/kg after single oral administration in female rats (reference 7.2.1 -1). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9cbf58f5-9431-46e2-b845-6b4c370f2fe9/documents/f8ee6638-7bf9-46c8-97b0-47a6ec98d3e7_a12a7e06-a81d-4e09-94bd-420e44628321.html,,,,,, Bis(acetato-O)hydroxyaluminium,142-03-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9cbf58f5-9431-46e2-b845-6b4c370f2fe9/documents/f8ee6638-7bf9-46c8-97b0-47a6ec98d3e7_a12a7e06-a81d-4e09-94bd-420e44628321.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Aluminum, benzoate C16-18-fatty acids complexes",94166-87-7,"An oral repeated dose toxicity study in rats incorporating reprotoxicity screening was conducted according to OECD 422 study design in which no adverse effect was seen in any of the toxicological parameters examined at any dose. The dose levels used were 0 (control), 375, 750 and 1500 mg/kg/day of the test substance as supplied in medicinal white oil. However, only 15% of these dose levels equate to the active substance i.e. 225 mg/kg/day at the high dose level. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7e90b8c-84b2-4f9e-8314-ebed4b2b1af0/documents/IUC5-f72f6956-6202-4497-bcc9-b81fbe4f7c56_2e857df2-bb16-479d-b225-8258b312874a.html,,,,,, "Aluminum, benzoate C16-18-fatty acids complexes",94166-87-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7e90b8c-84b2-4f9e-8314-ebed4b2b1af0/documents/IUC5-f72f6956-6202-4497-bcc9-b81fbe4f7c56_2e857df2-bb16-479d-b225-8258b312874a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,225 mg/kg bw/day,,rat "Aluminum, benzoate C16-18-fatty acids complexes",94166-87-7,An acute oral toxicity study determined an LD50 as >2000mg/kg bodyweight and an acute dermal toxicity study also determined an LD50 as >2000 mg/kg bodyweight. There is no evidence of a relevant intrinsic acute oral or dermal toxicity requiring classification or substance specific Risk Management Measures. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7e90b8c-84b2-4f9e-8314-ebed4b2b1af0/documents/IUC5-a9f33872-ef0a-4fbe-b8d4-3a31e781d0c1_2e857df2-bb16-479d-b225-8258b312874a.html,,,,,, "Aluminum, benzoate C16-18-fatty acids complexes",94166-87-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7e90b8c-84b2-4f9e-8314-ebed4b2b1af0/documents/IUC5-a9f33872-ef0a-4fbe-b8d4-3a31e781d0c1_2e857df2-bb16-479d-b225-8258b312874a.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Aluminum, benzoate C16-18-fatty acids complexes",94166-87-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7e90b8c-84b2-4f9e-8314-ebed4b2b1af0/documents/IUC5-a9f33872-ef0a-4fbe-b8d4-3a31e781d0c1_2e857df2-bb16-479d-b225-8258b312874a.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Aluminium fluoride,7784-18-1,"In a 12-month dietary feeding study conducted with the read-across substance Cryolite (trisodium hexafluoroaluminate), LOAEL values of 95 and 105 mg/kg body weight/day (the low-dose) were derived for male and female dogs, respectively (Tompkins, 1992). No other oral studies were identified.The key 28-day inhalation study was a GLP rat study conducted according to OECD testing guideline 412, in which a NOAEC of 7 mg/m3 (the mid-dose) was identified (Muijser and Junker, 2006). The key subchronic study was a 5-month study in rats that tested aluminum fluoride at a concentration equivalent to 0.41 mg aluminum/m3; however, limited details on experimental methods and results were presented (ATSDR, 2008).Dermal exposure is not considered the most relevant route of exposure; no dermal studies were identified. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92698646-3ce3-4f9a-ad54-dc23e2ff2802/documents/IUC5-ea47eeda-e5f5-4fae-935d-34c90dbd09f8_4d2fb0aa-ecb9-495d-a8ea-dfb8732cf378.html,,,,,, Aluminium fluoride,7784-18-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92698646-3ce3-4f9a-ad54-dc23e2ff2802/documents/IUC5-ea47eeda-e5f5-4fae-935d-34c90dbd09f8_4d2fb0aa-ecb9-495d-a8ea-dfb8732cf378.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,95 mg/kg bw/day,, Aluminium fluoride,7784-18-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92698646-3ce3-4f9a-ad54-dc23e2ff2802/documents/IUC5-ea47eeda-e5f5-4fae-935d-34c90dbd09f8_4d2fb0aa-ecb9-495d-a8ea-dfb8732cf378.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,7 mg/m3,, Aluminium fluoride,7784-18-1,"Aluminium fluoride is of low acute toxicity following oral exposure. The minimum lethal oral dose of AlF3 in rats was determined to be greater than 2000 mg/kg body weight in an OECD guideline and GLP-compliant study (Test No. 420) (Bollen, 2001). No treatment-related effects were observed in all parameters examined. In the IUCLID Dataset for aluminium fluoride as reported by the European Commission European Chemicals Bureau (2000), the minimum lethal oral dose of AlF3 in guinea pigs was determined to be equal to or greater than 600 mg/kg body weight; however, no conclusions regarding the reliability of this study could be reached based on the lack of detailed information.In accordance with column 2 of REACH (Regulation (EC) No 1907/2006) Annex VIII, the acute toxicity by dermal exposure study (required in section 8.5.3) does not need to be conducted as acute toxicity studies are available for the oral and inhalation routes of exposure.Aluminium fluoride also is of low acute toxicity following inhalational exposure to the maximum practicable concentration. The LC50 of AlF3 in rats was determined to be greater than 0.530 mg/L in air, the maximum practicable concentration, in an OECD guideline and GLP-compliant study (Test No. 403) (Coombs, 2002). Clinical signs observed during the exposure period included exaggerated breathing in all test rats from 4 hours into exposure. No other treatment-related effects were observed in all parameters examined. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92698646-3ce3-4f9a-ad54-dc23e2ff2802/documents/IUC5-ac289143-5ed8-4a3b-b851-da9c58918f76_4d2fb0aa-ecb9-495d-a8ea-dfb8732cf378.html,,,,,, Aluminium hydroxide,21645-51-2,"Based on read-acrossOral: NOAEL (chronic, rat) 30 mg Al/kg bw/day as aluminium citrate.Inhalation: LOAEC (subchronic, rat) 70 mg Al/m³ as aluminium oxide. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad69fd8d-157d-4c0d-8285-2128387dcb63/documents/ef0e4f2e-3301-48d1-a47f-c29b81a30804_cf4d7d93-53c2-4340-a4cc-86a026553a3d.html,,,,,, Aluminium hydroxide,21645-51-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad69fd8d-157d-4c0d-8285-2128387dcb63/documents/ef0e4f2e-3301-48d1-a47f-c29b81a30804_cf4d7d93-53c2-4340-a4cc-86a026553a3d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,70 mg/m3,,rat Aluminium hydroxide,21645-51-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad69fd8d-157d-4c0d-8285-2128387dcb63/documents/ef0e4f2e-3301-48d1-a47f-c29b81a30804_cf4d7d93-53c2-4340-a4cc-86a026553a3d.html,Chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat Aluminium hydroxide,21645-51-2,"It is recommended that aluminium hydroxide is not to be classified for acute oral, dermal and inhalation toxicity.Oral LD50 (rat) > 2000 mg/kg bwInhalation LC50 (rat) >  2.3 mg/L ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad69fd8d-157d-4c0d-8285-2128387dcb63/documents/84063918-2ac4-4212-926e-8b045dcf2750_cf4d7d93-53c2-4340-a4cc-86a026553a3d.html,,,,,, Aluminium triisopropanolate,555-31-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b32525f-076e-44e4-92f9-9f07cf433b04/documents/030844e4-889d-45c6-8124-ea462414e1ac_6f4a90a8-febb-4f50-a08c-29154ce955b5.html,,oral,LD50,"11,300 mg/kg bw",no adverse effect observed, Aluminium trilactate,18917-91-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): All reported studies are of high quality (Klimisch score=2). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/585bdc3b-a911-4d53-a428-194493af7774/documents/IUC5-51c05c03-b01f-48aa-8768-009508ddb8d9_4c4be85a-1e29-410e-b6b0-0e0c25f9d837.html,,,,,, Aluminium trilactate,18917-91-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/585bdc3b-a911-4d53-a428-194493af7774/documents/IUC5-51c05c03-b01f-48aa-8768-009508ddb8d9_4c4be85a-1e29-410e-b6b0-0e0c25f9d837.html,Chronic toxicity – systemic effects,oral,NOAEL,294.41 mg/kg bw/day,,dog Aluminium trilactate,18917-91-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The key study is GLP compliant and of high quality (Klimisch score = 1). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/585bdc3b-a911-4d53-a428-194493af7774/documents/IUC5-ab2c0432-3bc7-4ff4-96c1-fb6577876304_4c4be85a-1e29-410e-b6b0-0e0c25f9d837.html,,,,,, Aluminium trilactate,18917-91-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/585bdc3b-a911-4d53-a428-194493af7774/documents/IUC5-ab2c0432-3bc7-4ff4-96c1-fb6577876304_4c4be85a-1e29-410e-b6b0-0e0c25f9d837.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Aluminum magnesium oxide,11137-98-7," A repeated dose 28-day oral toxicity study in rats performed according to OECD 407 guideline and GLP principles is available, the NOAEL was determined to be 1000 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f352c685-2e9e-4286-ba56-44deb7568143/documents/47b87931-6063-4344-88a4-ee269469a81a_30603b57-ce98-41cd-be32-d882cf606fc7.html,,,,,, Aluminum magnesium oxide,11137-98-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f352c685-2e9e-4286-ba56-44deb7568143/documents/47b87931-6063-4344-88a4-ee269469a81a_30603b57-ce98-41cd-be32-d882cf606fc7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Aluminum magnesium oxide,11137-98-7, Acute oral (OECDTG423): LD50 >2000 mg/kg bw Acute inhalation (OECDTG403): LC50 >5 mg/L ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f352c685-2e9e-4286-ba56-44deb7568143/documents/6c10dd65-6ab0-49d1-8256-1a91433fda29_30603b57-ce98-41cd-be32-d882cf606fc7.html,,,,,, Aluminum magnesium oxide,11137-98-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f352c685-2e9e-4286-ba56-44deb7568143/documents/6c10dd65-6ab0-49d1-8256-1a91433fda29_30603b57-ce98-41cd-be32-d882cf606fc7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Aluminum magnesium oxide,11137-98-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f352c685-2e9e-4286-ba56-44deb7568143/documents/6c10dd65-6ab0-49d1-8256-1a91433fda29_30603b57-ce98-41cd-be32-d882cf606fc7.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Aluminatesilicate,1327-36-2,"Oral: Subchronic: OECD408, rat: NOEL = 8% in diet / 4 g/kg bw/d (diet; read across to CAS 7631-86-9)   Inhalation: OECD413, rat: NOAEC < 34.9 mg/m³ air (read across to CAS 7631-86-9) OECD413, rat: NOAEC = 1.3 mg/m³ air (read across to CAS 7631-86-9) Similar to OECD413, rat: NOAEC < 50 mg/m³ air (read across to CAS 7631-86-9) OECD413, rat: NOAEC = 5 mg/m³ air (systemic) and 1 mg/m³ air (local) (read across to CAS 7631-86-9) OECD413, rat: LOAEC = 2.5 mg/m³ air (read across to CAS 7631-86-9)   Dermal: No data ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06c6cd7d-eff1-47f8-9e57-30cc91b86917/documents/0fc38b43-9e26-4e1b-9a52-d189822925a5_a9220559-1c76-4d73-8d4a-9d276cfdc2af.html,,,,,, Aluminatesilicate,1327-36-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06c6cd7d-eff1-47f8-9e57-30cc91b86917/documents/0fc38b43-9e26-4e1b-9a52-d189822925a5_a9220559-1c76-4d73-8d4a-9d276cfdc2af.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"4,000 mg/kg bw/day",,rat Aluminatesilicate,1327-36-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06c6cd7d-eff1-47f8-9e57-30cc91b86917/documents/0fc38b43-9e26-4e1b-9a52-d189822925a5_a9220559-1c76-4d73-8d4a-9d276cfdc2af.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,1 mg/m3,,rat Aluminatesilicate,1327-36-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06c6cd7d-eff1-47f8-9e57-30cc91b86917/documents/0fc38b43-9e26-4e1b-9a52-d189822925a5_a9220559-1c76-4d73-8d4a-9d276cfdc2af.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1 mg/m3,no adverse effect observed,rat Aluminatesilicate,1327-36-2,"Acute oral toxicity (read-across to synthetic amorphous silica): LD50 > 2000 mg/kg bw/dAcute oral toxicity (read-across to silic acid, aluminium salt): LD50 > 2000 mg/kg bw/dAcute inhalation toxicity: LC50 > 5 mg/kg bw/dAcute inhalation toxicity (read-across to synthetic amorphous silica): > 5 mg/kg bw/dAcute dermal toxicity (read-across to silic acid, aluminium salt): > 2000 mg/kg bw/dAcute dermal toxicity (read-across to synthetic amorphous silica): > 2000 mg/kg bw/d ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06c6cd7d-eff1-47f8-9e57-30cc91b86917/documents/424f083f-1423-4be9-9dd6-ea5a96f28bf1_a9220559-1c76-4d73-8d4a-9d276cfdc2af.html,,,,,, Aluminatesilicate,1327-36-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06c6cd7d-eff1-47f8-9e57-30cc91b86917/documents/424f083f-1423-4be9-9dd6-ea5a96f28bf1_a9220559-1c76-4d73-8d4a-9d276cfdc2af.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Aluminatesilicate,1327-36-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06c6cd7d-eff1-47f8-9e57-30cc91b86917/documents/424f083f-1423-4be9-9dd6-ea5a96f28bf1_a9220559-1c76-4d73-8d4a-9d276cfdc2af.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Aluminatesilicate,1327-36-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06c6cd7d-eff1-47f8-9e57-30cc91b86917/documents/424f083f-1423-4be9-9dd6-ea5a96f28bf1_a9220559-1c76-4d73-8d4a-9d276cfdc2af.html,,inhalation,LC50,> 5 mg/L,no adverse effect observed, Aluminium sulphate,10043-01-3," Combined repeated dose / reproductive screening study (OECD 422): study performed on Aluminium chloride basic relevant for Aluminium sulphate in a read-across approach based on Aluminium  (Al3+)  toxicity (K, Reliability 1). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3458dc88-ae7f-4091-9dd4-c619dd79da05/documents/IUC5-dd9eac27-91a5-4e74-bd0c-7cd48de41ce3_7f9ab5af-d9de-4b11-a47d-a748d50ea06a.html,,,,,, Aluminium sulphate,10043-01-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3458dc88-ae7f-4091-9dd4-c619dd79da05/documents/IUC5-dd9eac27-91a5-4e74-bd0c-7cd48de41ce3_7f9ab5af-d9de-4b11-a47d-a748d50ea06a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,142 mg/kg bw/day",,rat Aluminium sulphate,10043-01-3," - Acute toxicity: oral: The acute oral median lethal dose to rats of Aluminum sulphate, hydrate was found to be greater than 2000 mg/kg bodyweight and less than 5000 mg/kg bw (comparable to OECD 401, Kr: 2). - Acute toxicity: dermal: The Single Dose Acute Dermal LD50 of Aluminum Sulfate, Hydrate applied to the skin for 24 hours, is greater than 5000 mg/kg bw  (comparable to OECD 402, Kr: 2) . - Acute toxicity: inhalation: No data available on the registered substance. However, two studies performed on analogous (CAS N°: 39290-78-3 and Catapal Alumina Fines) were available. In these studies (OECD 403, Kr. 2, GLP), the LC50, 4h value (droplet or particle aerosol) in rats was considered to exceed 5 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3458dc88-ae7f-4091-9dd4-c619dd79da05/documents/IUC5-32b28ea4-81ba-425d-bb80-bb5ff73f5b19_7f9ab5af-d9de-4b11-a47d-a748d50ea06a.html,,,,,, Aluminium sulphate,10043-01-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3458dc88-ae7f-4091-9dd4-c619dd79da05/documents/IUC5-32b28ea4-81ba-425d-bb80-bb5ff73f5b19_7f9ab5af-d9de-4b11-a47d-a748d50ea06a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Aluminium sulphate,10043-01-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3458dc88-ae7f-4091-9dd4-c619dd79da05/documents/IUC5-32b28ea4-81ba-425d-bb80-bb5ff73f5b19_7f9ab5af-d9de-4b11-a47d-a748d50ea06a.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Aluminium sulphate,10043-01-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3458dc88-ae7f-4091-9dd4-c619dd79da05/documents/IUC5-32b28ea4-81ba-425d-bb80-bb5ff73f5b19_7f9ab5af-d9de-4b11-a47d-a748d50ea06a.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Aluminium triformate,7360-53-4,Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test: OECD 422: NOAEL (males and females) 316 mg/kg body weight. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96662836-2688-4e7f-be1f-0cb26d9cd869/documents/IUC5-63f1b1cd-2c45-46c7-8629-e7b3595673a8_3b615a6d-067d-40d6-8b8f-1bd8596e833e.html,,,,,, Aluminium triformate,7360-53-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96662836-2688-4e7f-be1f-0cb26d9cd869/documents/IUC5-63f1b1cd-2c45-46c7-8629-e7b3595673a8_3b615a6d-067d-40d6-8b8f-1bd8596e833e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,316 mg/kg bw/day,,rat Aluminium triformate,7360-53-4,"Acute oral toxicity: OECD420, EU method B.1 bis: LD50 >2000 mg/kg body weightAcute inhalation toxicity: OECD 403, EU method B.2: LC50 >2.51 mg/L (highest tchnically feasible dust concentration) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96662836-2688-4e7f-be1f-0cb26d9cd869/documents/IUC5-a35114fd-d838-4354-8f88-61f1ff8cc90d_3b615a6d-067d-40d6-8b8f-1bd8596e833e.html,,,,,, Aluminium triformate,7360-53-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96662836-2688-4e7f-be1f-0cb26d9cd869/documents/IUC5-a35114fd-d838-4354-8f88-61f1ff8cc90d_3b615a6d-067d-40d6-8b8f-1bd8596e833e.html,,oral,LD50,"2,000 mg/kg bw",, Aluminium triformate,7360-53-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96662836-2688-4e7f-be1f-0cb26d9cd869/documents/IUC5-a35114fd-d838-4354-8f88-61f1ff8cc90d_3b615a6d-067d-40d6-8b8f-1bd8596e833e.html,,inhalation,LC50,"2,510 mg/m3",, Aluminium dihydrogen triphosphate,13939-25-8,"NOAEL (46 days, rats): 300 mg/kg bw/day (Aluminium dihydrogen triphosphate (EC 237-714-9), OECD 422, GLP )NOAEL (90 days, dogs): 322.88 mg/kg bw/day (read-across from Sodium aluminium phosphate (CAS 7785-88-8)) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/40733701-0e44-4d8d-a4bf-3bc11265c133/documents/IUC5-2f462e9b-816d-4f24-b6ae-54086256864c_935fa7fe-b45e-41f5-8366-31a28fe32598.html,,,,,, Aluminium dihydrogen triphosphate,13939-25-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/40733701-0e44-4d8d-a4bf-3bc11265c133/documents/IUC5-2f462e9b-816d-4f24-b6ae-54086256864c_935fa7fe-b45e-41f5-8366-31a28fe32598.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,322.88 mg/kg bw/day,,dog Aluminium dihydrogen triphosphate,13939-25-8,"Oral: LD50(rat, m/f) > 2000 mg/kg bw (OECD 401 and 420, GLP)Inhalation: LC50(rat, m/f) > 3.46 mg/L (max. achievable concentration, OECD 436, GLP)Dermal: no study available ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40733701-0e44-4d8d-a4bf-3bc11265c133/documents/IUC5-3dca13bc-cdd3-4fb0-af85-21417cde862f_935fa7fe-b45e-41f5-8366-31a28fe32598.html,,,,,, Aluminium dihydrogen triphosphate,13939-25-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40733701-0e44-4d8d-a4bf-3bc11265c133/documents/IUC5-3dca13bc-cdd3-4fb0-af85-21417cde862f_935fa7fe-b45e-41f5-8366-31a28fe32598.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Aluminium dihydrogen triphosphate,13939-25-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40733701-0e44-4d8d-a4bf-3bc11265c133/documents/IUC5-3dca13bc-cdd3-4fb0-af85-21417cde862f_935fa7fe-b45e-41f5-8366-31a28fe32598.html,,inhalation,discriminating conc.,"3,460 mg/m3",no adverse effect observed, "Tris(N-hydroxy-N-nitrosophenylaminato-O,O')aluminium",15305-07-4," The median lethal dose of RCX 15-116 after a single oral administration to female rats, observed over a period of 14 days is: LD50cut-off (rat): 500 mg/ kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/decc5c78-60ac-40b1-8d67-976b30ac092e/documents/5c42bbef-94b2-42c3-a7ab-d8151126624d_3fcb44cf-b7be-4f7e-9f39-c05201d6b250.html,,,,,, "Tris(N-hydroxy-N-nitrosophenylaminato-O,O')aluminium",15305-07-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/decc5c78-60ac-40b1-8d67-976b30ac092e/documents/5c42bbef-94b2-42c3-a7ab-d8151126624d_3fcb44cf-b7be-4f7e-9f39-c05201d6b250.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Aluminium tristearate,637-12-7, Acute oral toxicity: LD50 was considered to be > 5000 mg/kg bw when rats were treated with aluminum trioctadecanoate orally. Acute dermal toxicity: LD50 was considered to be > 3000 mg/kg bw when Guinea pigs were treated with aluminum trioctadecanoate orally. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74814483-69dd-4b86-863f-9c0fc62b2ed0/documents/db0c4a56-605b-47b2-b6c7-afbf72d17b1c_620cc77a-5052-4d7b-bc39-b2faa8add472.html,,,,,, Aluminium tristearate,637-12-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74814483-69dd-4b86-863f-9c0fc62b2ed0/documents/db0c4a56-605b-47b2-b6c7-afbf72d17b1c_620cc77a-5052-4d7b-bc39-b2faa8add472.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Aluminium tristearate,637-12-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74814483-69dd-4b86-863f-9c0fc62b2ed0/documents/db0c4a56-605b-47b2-b6c7-afbf72d17b1c_620cc77a-5052-4d7b-bc39-b2faa8add472.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, Dialuminium zinc tetraoxide,12068-53-0," An oral repeated dose 28-Day toxicity study in rodents (OECD 407) is available. NOAEL (oral, rat) >= 1000 mg/kg bw/day (m/f) for systemic toxicity ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3506f461-78fc-46fc-b420-33967ea9ba2b/documents/a9177be8-ca6d-4434-b8a8-7768e5421371_23ddacf7-dd39-492b-85fe-003cb6eb8425.html,,,,,, Dialuminium zinc tetraoxide,12068-53-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3506f461-78fc-46fc-b420-33967ea9ba2b/documents/a9177be8-ca6d-4434-b8a8-7768e5421371_23ddacf7-dd39-492b-85fe-003cb6eb8425.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dialuminium zinc tetraoxide,12068-53-0," Oral, rat: LD50 cut-off value: unclassified (Colas, 2011a) Inhalation, rat: WoE LC50: > 5 mg/m³ (RA CAS 1314-13-2, maximal attainable concentration under experimental conditions) Dermal, rat: LD50: > 2000 mg/kg bw (Colas, 2011b) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3506f461-78fc-46fc-b420-33967ea9ba2b/documents/IUC5-8f5b965f-c230-465a-b90b-81324a0347d9_23ddacf7-dd39-492b-85fe-003cb6eb8425.html,,,,,, 2-amino-2-ethylpropanediol,115-70-8," Oral (OECD 422 with AEPD), 42 days, rat: NOAEL (systemic) ≥ 1000 mg/kg bw/day Oral (OECD 408 with APD), 90 days, rats: NOAEL (systemic) 250 mh/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16bc8614-447d-40dc-b1b8-07b0b118cb38/documents/IUC5-4b9ffdf7-b645-4cd4-a6cb-080c23a977d6_6e769aff-6b11-48ca-933e-2555df3447b9.html,,,,,, 2-amino-2-ethylpropanediol,115-70-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16bc8614-447d-40dc-b1b8-07b0b118cb38/documents/IUC5-4b9ffdf7-b645-4cd4-a6cb-080c23a977d6_6e769aff-6b11-48ca-933e-2555df3447b9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-amino-2-ethylpropanediol,115-70-8,"Oral (OECD 423), rat: LD50 = 5000 mg/kg bw (cut-off value, limit test)Dermal, rat: LD50 > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16bc8614-447d-40dc-b1b8-07b0b118cb38/documents/IUC5-cb587344-d9a2-4ce8-a502-a49e6211a9f7_6e769aff-6b11-48ca-933e-2555df3447b9.html,,,,,, 2-amino-2-ethylpropanediol,115-70-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16bc8614-447d-40dc-b1b8-07b0b118cb38/documents/IUC5-cb587344-d9a2-4ce8-a502-a49e6211a9f7_6e769aff-6b11-48ca-933e-2555df3447b9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-aminoethyl hydrogen sulphate,926-39-6, Publication: Gigiena Truda i Professional'nye Zabolevaniya. Labor Hygiene and Occupational Diseases. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec379397-0b66-4ba2-bedc-7a5713265ccb/documents/417c1600-915e-46f0-9eaf-397600718a3f_43987100-4b4b-4e7f-9000-82e043e24634.html,,,,,, 2-aminoethyl hydrogen sulphate,926-39-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec379397-0b66-4ba2-bedc-7a5713265ccb/documents/417c1600-915e-46f0-9eaf-397600718a3f_43987100-4b4b-4e7f-9000-82e043e24634.html,,oral,LD50,"1,100 mg/kg bw",adverse effect observed, Aminoguanidinium hydrogen carbonate,2582-30-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Two studies were performed according to the respective OECD guideline under GLP conditions and evaluated with a Klimisch score 1. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5047a299-4c56-481d-ab8a-8ec8e0dd2f89/documents/IUC5-3aa5ecdb-49bd-4ff9-bf6c-a0497e196fbf_ab9a290c-0f62-4ad2-803e-f960ccb0fbe0.html,,,,,, Aminoguanidinium hydrogen carbonate,2582-30-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5047a299-4c56-481d-ab8a-8ec8e0dd2f89/documents/IUC5-3aa5ecdb-49bd-4ff9-bf6c-a0497e196fbf_ab9a290c-0f62-4ad2-803e-f960ccb0fbe0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,88 mg/kg bw/day,,rat Aminoguanidinium hydrogen carbonate,2582-30-1,The LD(50) rat oral is > 5000 mg/kg bwThe LD(50) rat dermal is > 5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5047a299-4c56-481d-ab8a-8ec8e0dd2f89/documents/IUC5-c0a835a5-15c5-49b1-bb82-ce59fdaaaa2e_ab9a290c-0f62-4ad2-803e-f960ccb0fbe0.html,,,,,, Aminoguanidinium hydrogen carbonate,2582-30-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5047a299-4c56-481d-ab8a-8ec8e0dd2f89/documents/IUC5-c0a835a5-15c5-49b1-bb82-ce59fdaaaa2e_ab9a290c-0f62-4ad2-803e-f960ccb0fbe0.html,,oral,discriminating dose,"5,000 mg/kg bw",adverse effect observed, Aminoguanidinium hydrogen carbonate,2582-30-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5047a299-4c56-481d-ab8a-8ec8e0dd2f89/documents/IUC5-c0a835a5-15c5-49b1-bb82-ce59fdaaaa2e_ab9a290c-0f62-4ad2-803e-f960ccb0fbe0.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Carbazamidine monohydrochloride,1937-19-5, LD50 (oral) > 5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a181e48-1f54-4a4a-90cd-ec95a8796c23/documents/43498b37-125f-498b-a12e-f1bf9d10d08a_ae35e8d9-97e4-4fcf-a6a1-6abe5741f072.html,,,,,, Carbazamidine monohydrochloride,1937-19-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a181e48-1f54-4a4a-90cd-ec95a8796c23/documents/43498b37-125f-498b-a12e-f1bf9d10d08a_ae35e8d9-97e4-4fcf-a6a1-6abe5741f072.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-amino-2-methylpropane-1,3-diol",115-69-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/52f1d0ea-ba4e-4df2-8c0d-a2b3a64ff598/documents/IUC5-581f8455-21f5-46f2-a6e4-a7af17364574_8a94aa23-ba69-4065-bd45-bb5c2a16cd49.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "2-amino-2-methylpropane-1,3-diol",115-69-5,"Oral toxicity: key study in rats using APD (category member), 3 supporting studies from Category Members (AEPD and AMPD)Dermal: key study in rabbits conducted on APD, one supporting study from category member AEPD ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52f1d0ea-ba4e-4df2-8c0d-a2b3a64ff598/documents/IUC5-c75033bb-5ae8-4309-9e7d-4e718fd13e0c_8a94aa23-ba69-4065-bd45-bb5c2a16cd49.html,,,,,, "2-amino-2-methylpropane-1,3-diol",115-69-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52f1d0ea-ba4e-4df2-8c0d-a2b3a64ff598/documents/IUC5-c75033bb-5ae8-4309-9e7d-4e718fd13e0c_8a94aa23-ba69-4065-bd45-bb5c2a16cd49.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-amino-2-methylpropane-1,3-diol",115-69-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52f1d0ea-ba4e-4df2-8c0d-a2b3a64ff598/documents/IUC5-c75033bb-5ae8-4309-9e7d-4e718fd13e0c_8a94aa23-ba69-4065-bd45-bb5c2a16cd49.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-amino-2-methylpropanol,124-68-5,"The REACH dataset on AMP (2-Amino-2-methylpropanol, CAS N° 124-68-5) contains data on AMP-HCl (2-Amino-2-methylpropanol hydrochloride, CAS N° 3207-12-3) which is a neutralized form.   A) ORAL ROUTE   I. Selection of key animal oral studies for long-term systemic DNEL: 15 animal studies are available on the repeated dose oral toxicity of AMP or AMP-HCl (including via reproduction and developmental toxicity studies) so the AMP toxicological database is of unprecedented quality and allows a highly robust assessment. Studies are outlined in Table 1 below. AMP was tested under multiple forms with variable pH (as highly alkaline AMP, pH-adjusted AMP, or AMP-HCl where pH is also artificially reduced), variable purity (industrial or high-purity grade) and dosing regimen (in diet or by gavage), in multiple species (rat, mouse, rabbit, dog, monkey) and over multiple dosing periods (5 days to 1 year). NB: Clinical data are also available and summarized in next sections. The liver was AMP's target organ in all animal studies which included suitable investigations. Generally, this was evidenced by increased liver enzymes and liver weight and hepatocyte vacuolation. Only in two dog studies were irreversible liver effects noted (hepatocyte necrosis and fibrosis). The only other toxic effect was local toxicity caused by the alkalinity of the test material, in studies with no or partial pH adjustment. There was no clear trend concerning relative sensitivity of males and females. Table 1: Overview of animal repeat-dose toxicity studies Study N° Reference Species Duration (weeks) AMP grade tested AMP form tested Dosage form pH at LOAEL, if AMP hadn't been neutralized Gives robust information about liver toxicity ? Irreversible liver toxicity observed ? NOAEL males NOAEL females LOAEL males LOAEL females MTD males MTD females  1 Pittz 1977 Rat 0.7 (5d) Industrial As is >11 at all doses No (liver histopathology after 10-day recovery) No ND ND ND ND 1000 to <2500 500 to <1000  2 Carney 2005 Rat 2 High-purity Neutralized No LOAEL No (no liver histopathology) ND ND ND ND ND not reached not reached  3  Carney 2005 Rat 5 to 8 High-purity Neutralized 10.6-10.7 Yes No 213 <71 710 71 not reached not reached  4 Goldenthal 1976 Rat 8 Industrial Neutralized ? 11.2-11.7 Yes No 162 345 314 717 not reached 717 to <1355  5 Lankas 1981 Rat 13 Industrial Neutralized 10.8-11.1 Partial (liver histopathology at top-dose only) No 19 23 187 233 not reached not reached  6 Pittz 1977/1979  Rat 13 Industrial As is >11 at all doses No (no liver histopathology) ND ND ND ND ND < 500 500 to <750  7 Pittz 1977/1979  Rat 13 Industrial Neutralized 12.3 Partial (liver histopathology at top-dose only) No <=750 <=750 <=1100 <=1100 not reached not reached  8 Millard 2021 Rat 18 High-purity Neutralized 10.9-11.1 Yes No 71 >=142 142 not reached not reached not reached  9 Goldenthal 1976 Dog 4 Industrial Neutralized ? 11.0 Yes Scattered hepatocyte necrosis, slight fibrosis 20 19 54 70 54 to <62 70 to <108  10 Lankas 1981 Dog 14 Industrial Neutralized 11.0-11.2 Yes Very slight scattered hepatocyte necrosis, moderate fibrosis 17 17 81 82 not reached not reached  11 Griffin 1990/1993 Dog 26 Industrial Neutralized No LOAEL No (too low doses tested) No >=2.8 >=2.7 not reached not reached not reached not reached  12 Griffin 1990/1993 Dog 52 Industrial Neutralized No LOAEL No (too low doses tested) No >=2.7 >=2.4 not reached not reached not reached not reached  13 Pittz 1977 Monkey 0.7 (5d) Industrial As is >11 at all doses No (liver histopathology after 10-day recovery) No ND ND ND ND ND < 500  14 Murphy 2020 Rabbit 3 Industrial Neutralized 11.7 (at lethal dose) No (no liver histopathology) ND ND ND ND ND ND 23.7 to <71.0  15 Goldenthal 1976 Mouse 8 Industrial Neutralized ? No LOAEL No (too low doses tested) No >=501 >=685 not reached not reached not reached not reached NOAEL/LOAEL/MTD values in mg AMP (base)/kg/day. Blue: excludes use to derive a long-term DNEL. Bold: key studies. ND: not determined due to missing investigations. Red: excess pH, MTD would have been exceeded if AMP hadn’t been neutralized. Following selection criteria were used to select the two key studies to derive a long-term DNEL: studies shorter than 4 weeks are excluded; studies which failed to identify a LOAEL (too low dose-levels) are excluded; studies which did not investigate liver histopathology at all dose-levels are excluded, as liver is the target organ and histopathology the best way to determine adversity of effects; as above exclusion criteria pre-select 5 robust studies in two species (rats: 5-8, 8 and 18 weeks; dogs: 4 and 14 weeks), the study of longest duration in rat and dog is selected. As a consequence: for rats, the key study is the OECD 443 study (Millard 2021, 18 weeks);  for dogs, the key study is similar to OECD 409 (Lankas 1981, 14 weeks). Both studies involved neutralization of AMP via testing of AMP-HCl, and are thus largely over-conservative. This is further discussed below. II. Species sensitivity ranking by oral route: Studies are available in mouse, rat, rabbit, dog, monkey and human. We can rank their relative sensitivity for systemic toxicity by comparing MTD, NOAEL and LOAEL values for similar exposure durations: human cannot be ranked: only low dose-levels were tested so MTD and LOAEL values are not known (see details in next sections). concerning general toxicity based on comparison of MTD values: rabbits are more sensitive than monkeys over 5 days to 3 weeks: lethality was reached at 1000 mg AMP/kg bw/day in monkeys although pH was >11 (study N° 13), and as low as 71.0 mg AMP/kg bw/day in rabbits although pH was neutralized (study N° 14); rabbits are more sensitive than dogs over 3-4 weeks (studies N° 9 and 14); monkeys are more sensitive than rats over 5 days (studies N° 1 and 13); dogs are more sensitive than rats over 4-8 weeks (studies N° 3, 4 and 9); rats are more sensitive than mice over 8 weeks (studies N° 4 and 15). concerning liver toxicity based on comparison of NOAEL-LOAEL ranges: dogs are more sensitive than rats over 4-8 weeks (studies N° 3, 4 and 9) and 14-18 weeks (studies N° 8 and 10); rats are more sensitive than mice over 5-8 weeks (studies N° 3, 4 and 15). Therefore the sensitivity ranking is: general toxicity: rabbit > monkey/dog > rat > mouse (insufficient data to compare dog/monkey and to rank humans) liver toxicity: dog > rat > mouse (insufficient data to rank rabbit, monkey and humans) III. Description of key studies on AMP-HCl:  a) Rat 18-week study (Millard, 2021): In an OECD 443 study, groups of 19 to 30 CD rats/sex/dose were fed diets containing AMP-HCl over two generations. Toxicologically relevant effects were limited to liver toxicity in male rats of F0 and F1A generations (doses converted into AMP): At 142 mg AMP/kg bw/day, liver weights were 12% increased in F0 only, and minimal to moderate (adverse) hepatocellular vacuolation was seen in 24/30 F0 rats and 8/20 F1A rats; At 71 mg AMP/kg bw/day, non-adverse hepatocellular vacuolation was seen in 11/25 F0 rats (minimal to mild) and 7/22 F1A rats (minimal); At 35 mg AMP/kg bw/day, non-adverse minimal hepatocellular vacuolation was seen in 4/25 F0 rats and 1/22 F1A rats. The NOAEL for parental/general toxicity was 71 and 142 mg AMP/kg bw/day in males and females, resp. The absence of irreversible liver lesions means effects do not warrant STOT RE classification. At the LOAEL (males: 142 mg AMP/kg bw/day), diet contained 0.224-0.341 % w/w AMP, allowing to estimate that diet pH would range 10.9-11.1 (see Fernandes 2023 under IUCLID §4.20) if AMP hadn't been neutralized. Turner et al, 2011 (see IUCLID § 4.20) indicate that oral dosage above pH 9 may result in tissue necrosis and vascular thrombosis. Thus, if AMP had been tested as is instead of its neutralized form AMP-HCl, the study’s LOAEL could not have been reached due to dose-limiting, pH-mediated toxicity and no other toxic effects would have been noted. Since OECD guidelines referenced by REACH do NOT require any neutralization or pH adjustment, this study represents artificial dose maximization in excess of REACH principles, removing AMP's critical toxic effect which is pH-dependent non-specific toxicity. This bias introduced by neutralization, also affecting the two other key studies below, is discussed in more details below (part C)). Indirect proof of reversibility of liver effects observed in rats can be inferred by comparing LOAEL/NOAEL values in OECD 443 vs. OECD 421 on AMP-HCl: much longer exposure at same dose-level (71 mg AMP/kg/day) resulted in less frequent and pronounced liver effects at the time of histopathological examination. b) Dog 14-week study (Lankas, 1981): In a 14-week repeated-dose study similar to OECD 409, groups of 4 beagle dogs/sex/dose were fed diets containing AMP-HCl. Following effects were noted (doses converted into AMP): At 81 mg AMP/kg bw/day: Lower body weight gain and hemoglobin concentration. Multiple indications of liver toxicity: higher serum liver enzyme activities, lower cholesterol, increased liver weights, discoloration and mottling of liver, microscopic lesions including vacuolization, periportal cirrhosis (lipid deposition, hepatocellular necrosis and fibrosis) and bile duct hyperplasia. Also some local irritation: minimal to moderate chronic gastritis. At 17 mg AMP/kg bw/day: Non-adverse liver effects (increased weight, minimal to moderate reversible lesions) and local irritation (gastric inflammation). At 0.78 (males)/0.85 (females) mg AMP/kg bw/day: local irritation (gastric inflammation). The systemic NOAEL was 17 mg AMP/kg bw/day in both sexes. STOT RE classification does not apply, as discussed under ""Justification for classification or non-classification"". At the tested dietary concentratioins, pH would range 10.1-11.1 if AMP hadn't been neutralized. Thus, as the OECD 443 study, this study represents artificial and non-guideline dose maximization by orders of magnitude, removing of AMP's critical toxic effect, which is pH-dependent non-specific toxicity. This bias introduced by neutralization is discussed in more details below (part C)). When comparing liver lesions with those observed in the 4-week study by Goldenthal 1976, 3.5 times longer exposure at similar LOAEL values only lead to a marginal increase in grading of liver cirrhosis (see Table 1: moderate vs. slight fibrosis, necrosis stayed slight) at the time of histopathological examination. This again shows absence of accumulation of the test material in liver. IV. Human oral key studies on pamabrom (see Exposure related observations in humans, IUCLID § 7.10.3): Pamabrom is an Over The Counter (OTC) diuretic agent which is an AMP salt of 8-bromotheophylline, CAS No. 606-04-2. It is an equimolar mixture of 74.4% w/w 8-Bromotheophylline (CAS No. 10381-75-6) and 25.6% w/w AMP. Clinical data on this test material can be used for AMP safety assessment based on the AMP/Pamabrom bioequivalence study (see Basic Toxicokinetics /IUCLID §7.1.1) which indicated that Pamabrom’s AMP, and AMP as is, were equivalent in terms of AUC0-t, AUC0-inf and AUC0-168h. Pamabrom doses can be converted into equivalent AMP doses based on the AMP content of 25.6% w/w in this drug and assuming a patient weight of 70 kg when not indicated. a) Clinical trials: Six clinical studies are available on pamabrom. NOAELs are expressed in AMP based on pamabrom posology and AMP content. In all cases the below-listed NOAELs were the maximum tested dose: 1) Trial in severe cardiac failure patients (Doherty et al, 1953): Only 2/18 patients reported adverse effects potentially related to pamabrom upon longer treatment: 1/18 case of maculopapular rash (4th week of treatment) and 1/18 case of diarrhea (day 120 of treatment). A third patient stopped treatment after 2 weeks due to therapeutic success. The NOAEL was therefore >= 2.2 mg AMP/kg bw/day x 2 to 17 weeks depending on patient. 2) Trial in women with premenstrual tension - Preliminary study (McGavack et al, 1956): No adverse effect in n=9 women. The NOAEL was >= 2.9 mg AMP/kg bw/day x 4 weeks. 3) Trial in women with premenstrual tension - Main study (McGavack et al, 1956): No adverse effect in n=43 women. The NOAEL was >= 1.5 mg AMP/kg bw/day x 2 weeks (mean: variable   treatment regime). 4) Trial in women with primary dysmenorrhea (Ortiz et al, 2016): Minor effects in 3/189 patients (somnolence, dizziness and increased thirst, 1 case each). The NOAEL was >= 0.32 mg AMP/kg bw/day x 3 days. 5) Trial in pregnant women (Patterson, 1958): No adverse effects in n=38 pregnant women with edema classified as mild pre-eclampsia. The NOAEL was >= 5.9 mg AMP/kg bw/day x 1 week (if considering only the second treatment cycle), and >= 2.9 mg AMP/kg bw/day x 2 weeks (if considering both treatment cycles in patients treated twice). 6) Trial in pregnant women (James et al, 1957): No adverse effects in n=180 pregnant women with edema treated for unknown duration (Klimisch 4 study). The max. NOAEL was >= 2.2 mg AMP/kg bw/day, and in most patients it was >=1.6 mg AMP/kg bw/day. Considering all clinical trials, the most robust human NOAEL for repeat-dose toxicity comes from study 2) with monitoring of hematology and blood biochemistry. The NOAEL was >= 2.9 mg AMP/kg bw/day x 4 weeks. b) 70 years of safe clinical use - Pharmacovigilance argument: In the US, pamabrom is used since early 1950’s so it has a track-record of >70 years of safe use in an ill population. Based on the National Library of Medicines database, at least 20 US OTC drugs currently contain pamabrom (full list provided in study summary). Their claims include back/leg/joint pain and edema (1 drug) and premenstrual and menstrual pain/discomfort/edema (19 drugs). Based on contents and posology for each drug, AMP has a human NOAEL of >=0.73 mg AMP/kg/day for up to 10-day treatment cycles, repeated over periods. c) Overall human oral NOAEL for repeat-dose toxicity: No serious adverse effect was ever reported during 70 years of clinical trials and medication with pamabrom based on 5 publications (6 trials) and posology of 20 OTC drugs. The most robust human NOAEL for repeat-dose toxicity comes from study 2) (preliminary study by McGavack et al, 1956) where the NOAEL was >= 2.9 mg AMP/kg bw/day x 4 weeks. All other studies and OTC drug posology confirm AMP NOAEL values in the mg/kg bw/day range, always the highest tested dose whatever the treatment duration (3 days to 17 weeks + one trial where treatment duration was not indicated). The fact that the NOAEL in human is lower than in animals does not mean that humans are more sensitive, as no higher dose-levels have been tested in humans. Therefore the human NOAEL is underestimated and cannot be used to set any systemic DNEL values. V. Selection of final study for human long-term oral DNEL calculation: Key NOAEL values are available in rats and dogs as summarized below and both may in principle be used to derive a long-term human DNEL. However, interim calculations (simplified calculations not down to the actual DNEL value) are sufficient to demonstrate that a single NOAEL value can be selected to derive the long-term human DNEL values: Species Study Test item Study duration (weeks) Assessment factor for extrapolation to chronic exposure (1) Systemic NOAEL in most sensitive sex (mg AMP/kg bw/day) Actual body weight at NOAEL, week 1 to last study week, mean Allometric scaling factor to a 70kg-human, based on mean actual body weight (ECHA Guidance R.8, 2008) (2) Remaining interspecies variability Intraspecies variability (for general population) Corrected NOAEL (4) equivalent to a long-term systemic oral DNEL for general population Rat Millard, 2021 AMP-HCl 18 1 (1) 71 (males) 443g to 717g, mean: 580g (males) 3.31 2.5 10 = 71/1/3.31/2.5/10 = 0.86 mg AMP/kg bw/day Dog Lankas, 1981 AMP-HCl 14 2 17 (both sexes) 8.5kg to 10.6kg, mean 9.55kg (males) 8.4kg to 9.9kg, mean 9.15kg (females) overall mean: 9.35 kg 1.65 1.5 (3) 10 = 17/2/1.65/1.5/10 = 0.34 mg AMP/kg bw/day (1): assessment factor not required because OECD 443 showed less frequent/pronounced liver effects than OECD 421 study, showing no dependency upon exposure duration in rats (2): = (BWhuman/BWanimal)^0.25 (3): lower assessment factor used as the default value of 2.5 is when only rat studies are available, while we demonstrated above that dog is more sensitive than rats and mice (4): = systemic NOAEL /Assessment factor for extrapolation to chronic exposure /Allometric scaling factor /Remaining species differences (simplified calculation to allow simple comparison of rat and dog studies) bold: final key study to derive human long-term DNEL values This table demonstrates that the worst-case starting point to derive the human long-term systemic DNEL is the dog 14-week study (Lankas, 1981). Corrected NOAELs confirm that dogs are more sensitive than rats to AMP effects.   B) OTHER ROUTES I. Dermal route (Carney 2006): This OECD 414 study cannot be used to derive repeat-dose toxicity DNELs because: AMP was adjusted to pH 9.5 (limiting the potential to express local effects); The study did not include liver histopathology (leaving systemic effects unexplored). II. Inhalation route (Sullivan 2017): Nose-only exposure of rats to AMP aerosol (10% AMP solution in water) for 6 hours/day for 5 days at 700 to 2000 mg AMP/m3 resulted in: Significant local irritation/corrosion on skin (scabs, crusts, epidermal hyperplasia, mixed cell infiltrates, necrosis and ulceration); Significant local irritation/corrosion in nasal cavities (atrophy of goblet cells and olfactory epithelium, epithelium hyperplasia, mixed cell infiltrates, squamous metaplasia of respiratory epithelium, ulceration of turbinates); Minimal systemic toxicity in liver (increased aspartate aminotransferase, decreased albumin, higher liver weight, hepatocyte vacuolation). Based on Fernandes, 2023 (see IUCLID § 4.20), pH of a 10% AMP solution would be 12.3, confirming that the observed skin and respiratory tract lesions represent corrosive effects (local toxicity). The study conclusion did not distinguish local and systemic NOAEC/LOAEC values. Based on corrosion to skin/respiratory tract, the local LOAEC was <=700 mg/m3 in both sexes. Based on minimal liver vacuolation, the systemic NOAEC and LOAEC were 700 and 1400 mg/m3 in both sexes, resp. Minimal liver vacuolation being a reversible effect, STOT RE classification is not required. This study shows that the most sensitive general toxic effect upon inhalation of high airborne AMP concentrations is not liver toxicity but pH-related corrosion of respiratory tract and skin.   C) NON-RELEVANCE OF ADVERSE EFFECTS TO HUMANS I. Influence of pH adjustment on relevance of toxicology studies for hazard classification (see pH and pKa, IUCLID § 4.20/4.21): Bibliography on maximum tolerated pH, together with pH/concentration curves for AMP (Fernandes, 2023), allow to conclude that repeated administration of non-neutralized AMP solutions above: 0005% w/w for oral route (reaching pH 9, maximum tolerated pH by oral route according to Turner, 2011), or 8% w/w for topical application (reaching pH 11.5, maximum tolerated pH for skin according to Shu-Hua 2020, REACH regulation 2006, ECHA 2017), would lead to animal death or severe dose-limiting suffering. In almost all AMP in vivo toxicology studies (see IUCLID § 7.5.1, 7.5.3, 7.8), neutralization of AMP (pH adjustment or testing as hydrochloride salts) allowed to test much higher concentrations and (in some studies) observe toxic effects. Since OECD guidelines referenced by REACH do NOT require any neutralization or pH adjustment, such studies represent artificial dose maximization in excess of REACH principles, removing AMP's critical toxic effect which is pH-dependent non-specific toxicity. This is confirmed experimentally by the 4 in vivo repeat-dose studies (see IUCLID §7.5.1 and 7.5.2) where AMP was tested without pH adjustment: A 13-week oral rat study (Pittz 1977/79) was done in duplicate at 500 to 1700 mg AMP/kg bw/day with or without neutralization to pH 6.5-7.3 using HCl. Non-neutralized AMP triggered mortality from 500 mg/kg bw/day due to pH >11 in dosage forms, while neutralized AMP did not cause death up to 1700 mg/kg bw/day. This proves that neutralizing AMP artificially increases its maximum tolerated dose (MTD) by a factor of at least 3.5. In a 5-day study on rats inhaling non-neutralized AMP aerosols (Sullivan 2017), local corrosion to skin and respiratory tract occurred at much lower airborne concentrations (LOAEC: 700 mg/m3) than liver toxicity (non-adverse minimal hepatocyte vacuolation up to 2000 mg/m3). pH of the 10% aerosol was calculated as 12.3 using the pH curves. Thus, protecting against local effects upon inhalation will protect against systemic effects. In 5-day oral studies in rats and monkeys (Pittz 1977) where non-neutralized AMP reached pH >11, mortality occurred in both species. The maximum tolerated dose (MTD) in mg AMP/kg bw/day were: well below 500 in female monkeys; 500 in female rats; 1000 in male rats. No NOAEL could be set in either species due to a 10-day recovery before necropsy and liver examinations. GHS/CLP classification is about hazard and not about risk. It aims at identifying high-dose effects of the pure substance tested in animals according to OECD guidelines, not effects of a neutralized salt which is another chemical. AMP being a highly alkaline substance, this limits dose-levels and the pattern is dominated by local toxic effects. Identifying potential risks at low-dose as can exist in actual exposure conditions (where pH is balanced), is not the aim of GHS/CLP classification, but the aim of chemical risk assessment. Therefore, toxicity observed only thanks to adjustment of pH shall be ignored for classification but shall be considered for risk assessment (DNEL derivation). II. Ingestion (only route with adverse liver toxicity) is a negligible exposure route for REACH identified uses: Adverse liver effects were only observed after dietary ingestion of AMP-HCl (see IUCLID §7.5.1), and not in dermal and inhalation studies (see IUCLID § 7.5.2/7.5.3). The liver is the first organ exposed to AMP after gastro-intestinal absorption (first-pass effect), so the observed adverse effects on the liver can only occur upon direct ingestion. In humans, direct ingestion only happens via the OTC drug pamabrom and such US pharma uses are out of scope of REACH/GHS/CLP. AMP is not an approved food additive in EU and is not used to treat drinking water so REACH identified uses do not involve direct ingestion of AMP. AMP is extremely water soluble, readily biodegradable and non-bioaccumulative so no significant oral exposure to AMP via environmental emissions is expected from REACH identified uses. For all these reasons, toxicology data acquired by oral route are an extreme, barely realistic worst-case of actual systemic toxicity potential by exposure routes related to REACH uses. Indeed, by skin contact and inhalation, systemic exposure potential to AMP is very limited due to: risk management measures protecting against local corrosive effects of AMP and its industrial formulations (see CSR); negligible volatility (vapour pressure: 45 Pa at 20°C); few identified uses with a potential to generate aerosols (see IUCLID § 3.5 Use information); low concentration in end products (use as pH modifier, see CSR); only 7-17% dermal absorption of AMP through human skin (see IUCLID § 7.1.2 Dermal absorption); absence of liver first-pass effect by these routes: the liver is exposed to much smaller concentrations of AMP than by ingestion of the same total exposure dose. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7342c32c-1a67-48c2-9f39-27312e40004e/documents/IUC5-fdd00775-9189-40a9-96a9-0866bfbe9e42_730afe80-4067-4727-a7d5-91afbc7d30cd.html,,,,,, 2-amino-2-methylpropanol,124-68-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7342c32c-1a67-48c2-9f39-27312e40004e/documents/IUC5-fdd00775-9189-40a9-96a9-0866bfbe9e42_730afe80-4067-4727-a7d5-91afbc7d30cd.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,700 mg/m3,,rat 2-amino-2-methylpropanol,124-68-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7342c32c-1a67-48c2-9f39-27312e40004e/documents/IUC5-fdd00775-9189-40a9-96a9-0866bfbe9e42_730afe80-4067-4727-a7d5-91afbc7d30cd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,dog 2-amino-2-methylpropanol,124-68-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7342c32c-1a67-48c2-9f39-27312e40004e/documents/IUC5-fdd00775-9189-40a9-96a9-0866bfbe9e42_730afe80-4067-4727-a7d5-91afbc7d30cd.html,Repeated dose toxicity – local effects,inhalation,LOAEC,700 mg/m3,adverse effect observed,rat 2-amino-2-methylpropanol,124-68-5,"Oral studies: 1 study in the rat (key study), 1 study in the rabbit, 3 studies in the mouseDermal Studies: 1 study in the RabbitOther studies: 1 intraperitoneal study in the mouse ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7342c32c-1a67-48c2-9f39-27312e40004e/documents/IUC5-5529090d-7dae-4b9f-b6cd-96e65145106f_730afe80-4067-4727-a7d5-91afbc7d30cd.html,,,,,, 2-amino-2-methylpropanol,124-68-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7342c32c-1a67-48c2-9f39-27312e40004e/documents/IUC5-5529090d-7dae-4b9f-b6cd-96e65145106f_730afe80-4067-4727-a7d5-91afbc7d30cd.html,,oral,LD50,"2,900 mg/kg bw",, "3-aminopropane-1,2-diol",616-30-8,"The oral LD50 must be above 2000 mg Aminopropandiol/kg body weight (Scantox 2003, 14300).No data is availahle of acute toxicities by dermal and inhalation routes. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b59226d4-772d-4aa5-b5fd-ac13d894d153/documents/IUC5-74678854-86e2-4b75-b683-b97c4114f2b9_b768bc06-4591-495f-a3e2-cc75492d7759.html,,,,,, "3-aminopropane-1,2-diol",616-30-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b59226d4-772d-4aa5-b5fd-ac13d894d153/documents/IUC5-74678854-86e2-4b75-b683-b97c4114f2b9_b768bc06-4591-495f-a3e2-cc75492d7759.html,,oral,discriminating dose,"2,000 mg/kg bw",, Nitrilotrimethylenetris(phosphonic acid),6419-19-8," In a well-conducted key chronic toxicity/carcinogenicity study, ATMP-H (CAS 6419 -19 -8; EC No., 229-146-5; powder, 100% active acid) was administered via the diet to Long-Evans rats at dose levels of 50, 150 or 500 mg active acid/kg bw/day for 24 months. The NOAEL for carcinogenicity and general toxicity was at least 500 mg active acid/kg bw/day (BioDynamics Inc., 1979c, Reliability 2). The key repeated dose toxicity study on DTPMP sodium salt is included in support of read-across of the reproductive toxicity study on DTPMP (5-7Na) only. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6bdc8921-6e0f-430d-a06b-23a7f112c847/documents/7331f9ee-3604-4d83-937e-5656ca0817ed_0814a1ed-69be-4196-af50-48ffbd564d21.html,,,,,, Nitrilotrimethylenetris(phosphonic acid),6419-19-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6bdc8921-6e0f-430d-a06b-23a7f112c847/documents/7331f9ee-3604-4d83-937e-5656ca0817ed_0814a1ed-69be-4196-af50-48ffbd564d21.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Nitrilotrimethylenetris(phosphonic acid),6419-19-8," In the key acute oral toxicity study, conducted prior to OECD test guidelines and GLP but according to a protocol similar to the now-deleted OECD Test Guideline 401, an LD50 of 2910 mg active acid/kg bw (the doses were corrected for purity) was determined for ATMP-H (CAS 6419-19-8; EC No., 229-146-5 aqueous solution containing 25% active acid) in the rat (Younger Laboratories, 1967, Reliability 2). In the key acute dermal toxicity study conducted prior to the adoption of OECD test guidelines and GLP, but according to a protocol similar to OECD Test Guideline 402, the LD50 for ATMP-H (aqueous solution containing 25% w/w active acid) was concluded to be >6310 mg active acid/kg bw (Younger Laboratories, 1967, Reliability 2).  Key acute oral and dermal toxicity studies on ATMP-xNa are included in support of read-across of the reproductive toxicity study on DTPMP (5-7Na) only. Key acute toxicity studies on DTPMP acid and sodium salts are included in support of read-across of the reproductive toxicity study on DTPMP (5-7Na) only. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6bdc8921-6e0f-430d-a06b-23a7f112c847/documents/e2a397b0-32ad-4024-8c91-394aaf297572_0814a1ed-69be-4196-af50-48ffbd564d21.html,,,,,, Nitrilotrimethylenetris(phosphonic acid),6419-19-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6bdc8921-6e0f-430d-a06b-23a7f112c847/documents/e2a397b0-32ad-4024-8c91-394aaf297572_0814a1ed-69be-4196-af50-48ffbd564d21.html,,oral,LD50,"2,910 mg/kg bw",no adverse effect observed, Nitrilotrimethylenetris(phosphonic acid),6419-19-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6bdc8921-6e0f-430d-a06b-23a7f112c847/documents/e2a397b0-32ad-4024-8c91-394aaf297572_0814a1ed-69be-4196-af50-48ffbd564d21.html,,dermal,LD50,"> 6,310 mg/kg bw",no adverse effect observed, "Ammonia, anhydrous",7664-41-7," Ammonia is a gas and testing via the oral route is not feasible. Studies with read-across compounds diammonium phosphate and diammonium sulphate are available and provide useful information on the systemic toxicity of ammonia and its salts. Subacute, subchronic and chronic toxicity testing in rats with these source substances resulted in NOAEL values of 250, 868 and 258 mg/kg bw, which are equivalent to ‘target’ NOAEL values of 68, 225 and 67 mg/kg bw. Dermal effects will be dominated by local corrosion/irritation and significant systemic toxicity is not predicted. The repeated dose toxicity of the substance by inhalation has been adequately tested under a number of non-standard inhalation toxicity studies as weight-of-evidence. The data indicate that the primary effect of exposure to inhaled anhydrous ammonia is local irritation of the respiratory tract. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67c658ab-1a17-4008-bc2a-f32e5a35dab3/documents/83962c60-a99b-405d-a307-cd6e76975663_1b0ffe0c-2f1f-450f-b0d9-7daeeffd8e50.html,,,,,, "Ammonia, anhydrous",7664-41-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67c658ab-1a17-4008-bc2a-f32e5a35dab3/documents/83962c60-a99b-405d-a307-cd6e76975663_1b0ffe0c-2f1f-450f-b0d9-7daeeffd8e50.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,68 mg/kg bw/day,,rat "Ammonia, anhydrous",7664-41-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67c658ab-1a17-4008-bc2a-f32e5a35dab3/documents/83962c60-a99b-405d-a307-cd6e76975663_1b0ffe0c-2f1f-450f-b0d9-7daeeffd8e50.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,35 mg/m3,,rat "Ammonia, anhydrous",7664-41-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67c658ab-1a17-4008-bc2a-f32e5a35dab3/documents/83962c60-a99b-405d-a307-cd6e76975663_1b0ffe0c-2f1f-450f-b0d9-7daeeffd8e50.html,Repeated dose toxicity – local effects,inhalation,NOAEC,35 mg/m3,adverse effect observed,rat "Ammonia, anhydrous",7664-41-7, Anhydrous ammonia is a gas hence testing for acute toxicity via the oral route is technically unfeasible. The substance is corrosive and is classified accordingly: waivers are therefore proposed in respect of acute oral and dermal toxicity. A number of non-standard acute inhalation toxicity studies in the rat and mouse indicate that the substance is toxic by inhalation. A key LC50 value of 9850 mg/m³ in rats exposed for 60 minutes was retained. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67c658ab-1a17-4008-bc2a-f32e5a35dab3/documents/d4ac4673-b334-47e6-b786-1ac5146f9ae1_1b0ffe0c-2f1f-450f-b0d9-7daeeffd8e50.html,,,,,, "Ammonia, anhydrous",7664-41-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67c658ab-1a17-4008-bc2a-f32e5a35dab3/documents/d4ac4673-b334-47e6-b786-1ac5146f9ae1_1b0ffe0c-2f1f-450f-b0d9-7daeeffd8e50.html,,inhalation,LC50,"9,850 mg/m3",adverse effect observed, Ammonium acetate,631-61-8," Repeated dose toxicity: oral: Weight of evidence: Read-across approach from experimental results from non-standard studies on rats with Sodium Acetate and Citric acid, sodium salt and experimental results on rats treated with Ammonium Acetate. All these studies showed no signs of toxicity, even though in some studies, the limit dose was exceeded. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c31cdfb-6833-471e-8c9b-234c79a6256d/documents/IUC5-822e7b92-1016-4c95-8614-fa2b06400390_574ed43f-a4f4-4f0e-b394-4dc4fd2d072b.html,,,,,, Ammonium acetate,631-61-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c31cdfb-6833-471e-8c9b-234c79a6256d/documents/IUC5-822e7b92-1016-4c95-8614-fa2b06400390_574ed43f-a4f4-4f0e-b394-4dc4fd2d072b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"3,102.02 mg/kg bw/day",,rat Ammonium acetate,631-61-8, Acute oral toxicity: Weight of evidence: The LD50 was higher than 2000 mg/kg bw (2333.28-3546.59 mg/kg bw). Read-across approach from experimental results obtained with analogues Potassium Acetate and Ammonium Sulphate. The  read-across approach acute toxicity effect is lower than the subacute toxicity data obtained from an experimental study. The difference can be explained as an estimation error of the read across (the choosen value is the lowest one). Both results are higher than 2000 mg/kg/bw and  shows no oral toxicity of ammonium acetate. Acute dermal toxicity: Weight of evidence: The LD50 was greater than 2000 mg/kg bw (> 2333.28-26556.42 mg/kg bw). Read-across approach from experimental results obtained with analogues Fumaric Acid and Ammonium Sulphate. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c31cdfb-6833-471e-8c9b-234c79a6256d/documents/IUC5-07211653-6637-4e53-9ba5-bd544872ffbe_574ed43f-a4f4-4f0e-b394-4dc4fd2d072b.html,,,,,, Ammonium acetate,631-61-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c31cdfb-6833-471e-8c9b-234c79a6256d/documents/IUC5-07211653-6637-4e53-9ba5-bd544872ffbe_574ed43f-a4f4-4f0e-b394-4dc4fd2d072b.html,,oral,LD50,"2,338.28 mg/kg bw",, Ammonium acetate,631-61-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c31cdfb-6833-471e-8c9b-234c79a6256d/documents/IUC5-07211653-6637-4e53-9ba5-bd544872ffbe_574ed43f-a4f4-4f0e-b394-4dc4fd2d072b.html,,dermal,LD50,"2,338.28 mg/kg bw",, Aluminium ammonium bis(sulphate),7784-25-0,"- Combined repeated dose / reproductive screening study (OECD 422): study performed on Aluminium chloride basic relevant for Aluminium ammonium (bis)sulfate in a read-across approach based on Aluminium (Al3+) toxicity (K, Reliability 2)- Combined OECD426/OECD452: study conducted on Aluminium citrate relevant for Aluminium ammonium (bis)sulfate in a worst case read-across approach based on Aluminium (Al3+) toxicity (K, Reliability 2) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9c444d2-b44d-4830-8f9d-08898d2c437d/documents/IUC5-7fe8ce55-d520-408d-a33e-651099360a1a_eb7c07df-c7cf-4c69-a14c-f41443ee270d.html,,,,,, Aluminium ammonium bis(sulphate),7784-25-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9c444d2-b44d-4830-8f9d-08898d2c437d/documents/IUC5-7fe8ce55-d520-408d-a33e-651099360a1a_eb7c07df-c7cf-4c69-a14c-f41443ee270d.html,Chronic toxicity – systemic effects,oral,NOAEL,504 mg/kg bw/day,,rat Aluminium ammonium bis(sulphate),7784-25-0,"Acute toxicity: Oral: LD50 females: > 2000 mg/kg bw (K, Reliability 1)Acute toxicity: Dermal: LD50 combined: > 2000 mg/kg bw (K, Reliability 1)Acute toxicity: Inhalation: exposure based waiving ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9c444d2-b44d-4830-8f9d-08898d2c437d/documents/IUC5-8762c6a1-5dd4-4c33-a707-728581a7464e_eb7c07df-c7cf-4c69-a14c-f41443ee270d.html,,,,,, Aluminium ammonium bis(sulphate),7784-25-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9c444d2-b44d-4830-8f9d-08898d2c437d/documents/IUC5-8762c6a1-5dd4-4c33-a707-728581a7464e_eb7c07df-c7cf-4c69-a14c-f41443ee270d.html,,oral,LD50,"2,000 mg/kg bw",, Aluminium ammonium bis(sulphate),7784-25-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9c444d2-b44d-4830-8f9d-08898d2c437d/documents/IUC5-8762c6a1-5dd4-4c33-a707-728581a7464e_eb7c07df-c7cf-4c69-a14c-f41443ee270d.html,,dermal,LD50,"2,000 mg/kg bw",, Ammonium benzoate,1863-63-4," A literature reference is available summarizing test results of an acute oral toxicity test with rat and mice. An OECD SIDS report for analogoues substances Benzoic acid, Sodium Benzoate and Potassium Benzoate is available and taken into consideration as well as an in silico category approach on the HPV category of Benzoates. An OECD SIDS report for the analogoues substance Ammonium chloride is taken into consideration. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a9a7433-0fc0-4cd3-8b01-3df914778146/documents/d392d7c4-ff2b-494f-a55c-818ef00d1925_8df6d9a1-0946-4b8e-b64c-f6c61df0b177.html,,,,,, Ammonium benzoate,1863-63-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a9a7433-0fc0-4cd3-8b01-3df914778146/documents/d392d7c4-ff2b-494f-a55c-818ef00d1925_8df6d9a1-0946-4b8e-b64c-f6c61df0b177.html,,oral,LD50,825 mg/kg bw,adverse effect observed, Ammonium hydrogencarbonate,1066-33-7,"Repeated dose toxicity:- oral: NOAEL = 684 mg/kg bw/day (70 days feeding study; Analogy CAS 12125-02-9, ammonium chloride)-oral: NOAEL = 1695.6 mg/kg bw/day (13 weeks feeding study, Analogy CAS 12125-02-9, ammonium chloride)- inhalative: NOAEC = 262 mg/m3 air (90 days; Analogy 7664-41-7, ammonia, anhydrous) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51f27470-2118-4691-ac9c-81d45637389e/documents/IUC5-451bd8a6-fe8b-4a09-8e6b-328ca2df43a1_16adcb84-98fc-4633-8f87-b4f0a8a2d8cc.html,,,,,, Ammonium hydrogencarbonate,1066-33-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51f27470-2118-4691-ac9c-81d45637389e/documents/IUC5-451bd8a6-fe8b-4a09-8e6b-328ca2df43a1_16adcb84-98fc-4633-8f87-b4f0a8a2d8cc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,684 mg/kg bw/day,, Ammonium hydrogencarbonate,1066-33-7,Acute toxicity:- oral: LD50 = ca. 1576 mg/kg bw (OECD 401)- dermal: LD50 = >2000 mg/kg bw (OECD 403; Analogy CAS 7783-20-0)- inhalative: LC50 >4.74 mg/l (EPA OTS 798.1150; Analogy CAS 144-55-8) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51f27470-2118-4691-ac9c-81d45637389e/documents/IUC5-0c5da2a5-f438-4d2b-bd3b-2b8fe9ea9334_16adcb84-98fc-4633-8f87-b4f0a8a2d8cc.html,,,,,, Ammonium hydrogencarbonate,1066-33-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51f27470-2118-4691-ac9c-81d45637389e/documents/IUC5-0c5da2a5-f438-4d2b-bd3b-2b8fe9ea9334_16adcb84-98fc-4633-8f87-b4f0a8a2d8cc.html,,oral,LD50,"1,576 mg/kg bw",, Ammonium hydrogencarbonate,1066-33-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51f27470-2118-4691-ac9c-81d45637389e/documents/IUC5-0c5da2a5-f438-4d2b-bd3b-2b8fe9ea9334_16adcb84-98fc-4633-8f87-b4f0a8a2d8cc.html,,dermal,LD50,"2,000 mg/kg bw",, Ammonium hydrogencarbonate,1066-33-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51f27470-2118-4691-ac9c-81d45637389e/documents/IUC5-0c5da2a5-f438-4d2b-bd3b-2b8fe9ea9334_16adcb84-98fc-4633-8f87-b4f0a8a2d8cc.html,,inhalation,LC50,"4,740 mg/m3",, Ammonium hydrogensulphite,10192-30-0,"A 3-generation chronic toxicity study (Til et al. 1972a) with treatment of rats (20 per sex and group) with dose levels of 0, 0.125, 0.25, 0.5, 1.0 or 2.0% Na2S2O5 administered in a 50 ppm thiamine-containing diet was identified as most reliable study for repeated dose toxicity and was defined as key study (read-across info). Based on the read across concept for the group of sulfite substances, this result is also applicable to ammonium hydrogensulfite. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5316f4aa-9d33-412a-9970-53712a7a0aa6/documents/IUC5-ee3dbc6a-d65b-478e-a380-c1aaf3ef8d45_2bc58e6f-59aa-40cf-895a-b8d8d9bfbe03.html,,,,,, Ammonium hydrogensulphite,10192-30-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5316f4aa-9d33-412a-9970-53712a7a0aa6/documents/IUC5-ee3dbc6a-d65b-478e-a380-c1aaf3ef8d45_2bc58e6f-59aa-40cf-895a-b8d8d9bfbe03.html,Chronic toxicity – systemic effects,oral,NOAEL,113 mg/kg bw/day,,rat Ammonium hydrogensulphite,10192-30-0,"Based on the described read-across methodology information from sodium sulfite (CAS 7757-83-7), sodium metabisulfite (CAS 7681 -57 -4) and potassium metabisulfite (CAS 16731 -55 -8) were used to determine acute toxicity values (oral, dermal and inhalative) for ammonium hydrogensulfite.Please see `discussion` below. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5316f4aa-9d33-412a-9970-53712a7a0aa6/documents/IUC5-e40377f2-c1c3-4cb7-a891-f8cd1e3dda66_2bc58e6f-59aa-40cf-895a-b8d8d9bfbe03.html,,,,,, Ammonium carbamate,1111-78-0,"No data is available on repeated dose toxicity for ammonium carbamate. An assessment has been performed using data from ammonium chloride (CAS# 12125-02-9) and ammonium hydrogencarbonate (CAS# 1066-33-7). In a 90 day study with rats, a NOAEL of 1695.6 mg/kg bw/day was achieved. In a study with gaseous ammonia, using different species, a NOAEL of 262 mg/m3 was established for rats, using continuous (24 hr/day) exposure for 90 consecutive days, based on mortality at the next dose level. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b87c6d0-0572-4357-8ee8-6a009f56a324/documents/IUC5-1592866f-5c16-44fc-aedc-0c8cf268c456_3b3bfe26-efe4-45ae-bc05-fbbb6a58e052.html,,,,,, Ammonium carbamate,1111-78-0,"The results of an acute oral study according to OECD 401 was assessed as a key study. Here, a LD50 in the range of >681-< 1470 mg/kg bw was determined. No data are available for acute inhalation toxicity of ammonium carbamate. In a read across approach, data from ammonia and sodium bicarbonate assessing acute inhalation toxicity indicated an estimated LC50 of 6.6 mg/L/4 h (rats) and > 4.74 mg/L/4 h (rats), respectively. The LD50 assessed in an acute dermal toxicity study according to OECD 402 (key study) was > 5000 mg/kg bw in rats. This result is supported by the outcome of an older study (OECD 434) for ammonium sulfate, where a LD50 of >2000 mg/kg was determined. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b87c6d0-0572-4357-8ee8-6a009f56a324/documents/IUC5-57cd3382-8def-4318-893e-e6a7badbb45d_3b3bfe26-efe4-45ae-bc05-fbbb6a58e052.html,,,,,, Ammonium carbonate,10361-29-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d5087b11-e242-4b83-8582-ec166e5d00c1/documents/IUC5-46243f0a-43eb-4715-85bc-646c1e286d90_e45ba80d-5704-47fa-9a2b-177b03cda2e1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,256 mg/kg bw/day",, Ammonium carbonate,10361-29-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5087b11-e242-4b83-8582-ec166e5d00c1/documents/IUC5-21e612a1-05f3-435b-ac24-484c305ea8ff_e45ba80d-5704-47fa-9a2b-177b03cda2e1.html,,oral,LD50,"1,800 mg/kg bw",adverse effect observed, Ammonium chloride,12125-02-9,"In an in vivo repeated dose toxicity study similar to OECD guideline 408 in rats (Lina, 2004), a NOAEL (90 days) of 1695.6 mg/kg bw/d was determined. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5acd73ec-984b-47b3-b899-4a3fb3d8c616/documents/IUC5-f1a19b0e-678c-4b2b-843d-744b8d288c30_b635e75f-0d9c-41f7-83b0-f02a4c06919d.html,,,,,, Ammonium chloride,12125-02-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5acd73ec-984b-47b3-b899-4a3fb3d8c616/documents/IUC5-f1a19b0e-678c-4b2b-843d-744b8d288c30_b635e75f-0d9c-41f7-83b0-f02a4c06919d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,695.6 mg/kg bw/day",,rat Ammonium chloride,12125-02-9," Oral: In an acute oral toxicity study similar to OECD guideline 401 in rat, an LD50 of 1410 mg/kg bw was determined. Dermal: In an acute dermal toxicity study similar to EU method B.3 in rat, an LD50 of above 2000 mg/kg bw was determined. Inhalation: Not a relevant route of exposure. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5acd73ec-984b-47b3-b899-4a3fb3d8c616/documents/IUC5-c3ae0cfe-ce6a-4dfb-aa96-3fbe2c3549aa_b635e75f-0d9c-41f7-83b0-f02a4c06919d.html,,,,,, Ammonium chloride,12125-02-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5acd73ec-984b-47b3-b899-4a3fb3d8c616/documents/IUC5-c3ae0cfe-ce6a-4dfb-aa96-3fbe2c3549aa_b635e75f-0d9c-41f7-83b0-f02a4c06919d.html,,oral,LD50,"1,410 mg/kg bw",adverse effect observed, Ammonium chloride,12125-02-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5acd73ec-984b-47b3-b899-4a3fb3d8c616/documents/IUC5-c3ae0cfe-ce6a-4dfb-aa96-3fbe2c3549aa_b635e75f-0d9c-41f7-83b0-f02a4c06919d.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Ammonium dodecylbenzenesulphonate,1331-61-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The database is considered sufficient to fulfil the specific requirement. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f1e2a63-4d40-484d-a5dc-63779f806460/documents/IUC5-cd2c6c33-bfa2-4410-9e61-109b3da0eda8_aced7d4b-a819-46c9-ba09-4192199d332f.html,,,,,, Ammonium dodecylbenzenesulphonate,1331-61-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f1e2a63-4d40-484d-a5dc-63779f806460/documents/IUC5-cd2c6c33-bfa2-4410-9e61-109b3da0eda8_aced7d4b-a819-46c9-ba09-4192199d332f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,85 mg/kg bw/day,,rat Ammonium dodecylbenzenesulphonate,1331-61-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The oral LD50 of LAS IPA is higher than 2000 mg/kg bw. The whole database is sufficient to fully address this endpoint. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): According to REACH Regulation substances other than gases shall be tested through one more route except for the oral for acute toxicity (inhalation or demal). The dermal route was considered more appropriate for Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine, and therefore the requirement for acute inhalation toxicity is waived. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The calculated oral LD50 of LAS IPA (molar basis) is >2000 mg/kg bw. The whole database is sufficient to fully address this endpoint. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f1e2a63-4d40-484d-a5dc-63779f806460/documents/IUC5-0945efef-f608-43be-9a6a-2049a74f365e_aced7d4b-a819-46c9-ba09-4192199d332f.html,,,,,, Ammonium dodecylbenzenesulphonate,1331-61-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f1e2a63-4d40-484d-a5dc-63779f806460/documents/IUC5-0945efef-f608-43be-9a6a-2049a74f365e_aced7d4b-a819-46c9-ba09-4192199d332f.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Ammonium fluoride,12125-01-8,"In rodents, repeated exposure to fluoride salts, such as sodium fluoride, causes alteration of teeth at daily doses of 4 mg NaF/kg bw/day or greater. At higher doses of 10 and 25 mg NaF/kg bw/day an increase in dental effects was observed as well as toxic effects in bone and stomach. The severity of the toxic effects is related to increasing dose and duration of exposure. In a life-time chronic exposure study in the rats, an extremely high concentration of 175 ppm sodium fluoride in drinking water was associated with an increased incidence of osteosclerosis in female rats and equivocal evidence of osteosarcoma in male rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa32a467-aaa2-41a5-b3e9-51a64d1786a1/documents/IUC5-7c382532-4180-43e5-a020-da4f670041ff_703ee7dd-7ce4-4735-bca5-db23e9026ffd.html,,,,,, Ammonium fluoride,12125-01-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa32a467-aaa2-41a5-b3e9-51a64d1786a1/documents/IUC5-7c382532-4180-43e5-a020-da4f670041ff_703ee7dd-7ce4-4735-bca5-db23e9026ffd.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,10 mg/kg bw/day,, Ammonium fluoride,12125-01-8,"Based on the reported acute oral LD50 values for sodium fluoride in experimental animals, fluoride salts are considered moderately toxic if ingested ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa32a467-aaa2-41a5-b3e9-51a64d1786a1/documents/IUC5-93e25362-4dc5-476b-b60f-82470d62c972_703ee7dd-7ce4-4735-bca5-db23e9026ffd.html,,,,,, Ammonium fluoride,12125-01-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa32a467-aaa2-41a5-b3e9-51a64d1786a1/documents/IUC5-93e25362-4dc5-476b-b60f-82470d62c972_703ee7dd-7ce4-4735-bca5-db23e9026ffd.html,,oral,LD50,148.5 mg/kg bw,adverse effect observed, Ammonium fluoride,12125-01-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa32a467-aaa2-41a5-b3e9-51a64d1786a1/documents/IUC5-93e25362-4dc5-476b-b60f-82470d62c972_703ee7dd-7ce4-4735-bca5-db23e9026ffd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ammonium fluoride,12125-01-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa32a467-aaa2-41a5-b3e9-51a64d1786a1/documents/IUC5-93e25362-4dc5-476b-b60f-82470d62c972_703ee7dd-7ce4-4735-bca5-db23e9026ffd.html,,inhalation,LC50,"1,000 mg/m3",adverse effect observed, Ammonium hexafluorosilicate,16919-19-0, The LD50 of ammonium hexafluorosilicate was considered to be 70 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1675046-f922-4913-8cf4-98626d84fa3c/documents/098d0916-dfb3-40e1-95d4-a2a1d24ee56c_ba26d168-697e-4cd2-88dd-10f015a58a07.html,,,,,, Ammonium hexafluorosilicate,16919-19-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1675046-f922-4913-8cf4-98626d84fa3c/documents/098d0916-dfb3-40e1-95d4-a2a1d24ee56c_ba26d168-697e-4cd2-88dd-10f015a58a07.html,,oral,LD50,70 mg/kg bw,adverse effect observed, Ammonium glycyrrhizate,53956-04-0," See ""Justification for Classification"" ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5670e16-04a5-453d-8a2e-a3e47b5b6691/documents/d0b10082-be5a-4dd7-bede-6a9dfa528052_e750971d-6159-43d0-8f6f-167d69d3244d.html,,,,,, Ammonium glycyrrhizate,53956-04-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5670e16-04a5-453d-8a2e-a3e47b5b6691/documents/d0b10082-be5a-4dd7-bede-6a9dfa528052_e750971d-6159-43d0-8f6f-167d69d3244d.html,,oral,LD50,"12,700 mg/kg bw",no adverse effect observed, Ammonium N-methyl-N-(1-oxododecyl)glycinate,68003-46-3," Repeated dose toxicity - oral (no OECD, 2-year study), rat: NOAEL ≥ 1000 mg/kg bw/day Repeated dose toxicity - oral (OECD 408, 90-day), rat: NOAEL ≥ 250 mg/kg bw/day RA from source substance Sodium N-lauroylsarcosinate (CAS 137-16-6) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe29f97b-f558-4fca-9797-764b7025e2a4/documents/170666e6-1850-4a19-9625-b74fde7503cf_9f258e01-3139-48a6-bb5a-8fec5eb9af14.html,,,,,, Ammonium N-methyl-N-(1-oxododecyl)glycinate,68003-46-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe29f97b-f558-4fca-9797-764b7025e2a4/documents/170666e6-1850-4a19-9625-b74fde7503cf_9f258e01-3139-48a6-bb5a-8fec5eb9af14.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Ammonium N-methyl-N-(1-oxododecyl)glycinate,68003-46-3," Oral (OECD 420), rat: LD50 > 2000 mg/kg bw Inhalation: Data waiving as studies for two other routes, i.e. oral and dermal, are provided. Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe29f97b-f558-4fca-9797-764b7025e2a4/documents/IUC5-42f6cae4-d0e1-4a9e-8f58-a9e98e4ad37f_9f258e01-3139-48a6-bb5a-8fec5eb9af14.html,,,,,, Ammonium nitrate,6484-52-2,"A reliable 28-day oral OECD 422 study has been performed in rats (5 rats/sex/dose) via gavage, containing 50, 750 or 1500 mg/kg bw/day potassium nitrate. There were no treatment-related deaths and no signs of overt clinical toxicity. There were no effects on body weight, food consumption, or food efficiency. Functional observational battery (FOB) and motor activity tests identified no treatment-related changes in behavior, function, or motor activity. No treatment-related histopathological changes were reported. Therefore, it was concluded that the NOAEL is ≥ 1500 mg KNO3/kg bw/day, ≥920 mg nitrate/kg bw/day (or higher, highest dose tested). A reliable 28 -day oral OECD 407, EU B.7 guideline study has been performed in rats (5 rats/sex/dose) via gavage, containing 50, 150 or 1000 mg/kg bw/day Nitcal-K (potassium pentacalcium nitrate decahydrate). There were no treatment-related deaths and no signs of overt clinical toxicity. There were no effects on body weight, food consumption, or food efficiency. Functional observational battery (FOB) and motor activity tests identified no treatment-related changes in behavior, function, or motor activity. In haematology high-dose males reticulocytes and red cell distribution width were slightly increased; in high-dose females red blood cell count and haematocrit was slightly decreased. Reviewer: these changes are not consistent between males/females, are very slight, and three out of four appeared to be in the historical control range from this strain (based on NOTOX historical data) and this kind of study. Therefore, these are not considered adverse. At gross pathology a thickened limiting ridge and/or foci in glandular mucosa in 2 and 3 high-dose males and females, respectively, were noted. This is a local effect and reversible. At histopathology some non-neoplastic effects were observed: hyperplasia/hyperkeratosis of the limiting ridge of the stomach in 4 and 3 high dose males and females, respectively. This is considered a local effect and reversible according to the reviewer. In addition an increased severity of haemopoietic foci (erythroid) in the spleen at high dose was noted. Reviewer: The effect in the spleen is limited to one male and one female with a moderate severity at the high dose. However, this is a symptom expected in young animals in such a study, in addition it is considered a reversible effect. This is based on expertise of an experienced pathologist. Therefore, it was concluded that the NOAELsystemic is ≥1000 mg Nitcal-K/kg bw/day, ≥56 mg nitrate/kg bw/day(highest dose tested).  In conclusion, no systemic adverse effects were observed up to and including the highest dose tested in two 28-day oral toxicity studies. The data from the 104-week carcinogenicity study in rats (Maekawa et al., 1982) do not indicate adverse toxic effects / carcinogenic potential of sodium nitrate. The Maekawa et al. (1982) study was used by SCF and EFSA for the derivation of the ADI.  F344 rats (50 animals per sex per group, 8 weeks old) were given 0%, 2.5% and 5% sodium nitrate in the diet ad libitum (equivalent to 0, 1250 and 2500 mg/kg bw per day, or 0, 910, or 1820 mg/kg bw per day expressed as nitrate ion) in a 2-year feeding study (Maekawa et al., 1982). Rats in the control group were given a basic diet without nitrate ad libitum. Treatment was stopped at week 104 and the rats were given a basic diet until week 123 to account for the number of survivors in at least one group of either sex that was less than 20%. Diet and water consumption was constant in all groups throughout the study. The growth curves showed that the mean body weight of male fats did not differ more than 10%, whereas female rats differed by more than 10% in the high-dose group after week 60. However, no statistically significant differences were reported for this parameter. Treatment with sodium nitrate did not have statistically significant effect on survival rates, although male rats in the 5% group (equivalent to 2500 mg sodium nitrate/kg bw per day, 1820 mg nitrate ion/kg bw per day) had 10% higher cumulative mortality compared to the 2.5% group (equivalent to 1250 mg sodium nitrate/kg bw per day, 910 mg nitrate ion/kg bw per day). At the end of the study (2 years), both male and female control groups showed a statistically significant lower number of survivors compared to both treatment groups. However, the mean survival time did not differ significantly among all groups. The incidence of tumours in all groups, including controls, was high. For example, the percentage of animals showing tumours in the control groups was reported to reach 94% and 92% for male and female rats, respectively. In male rats from the 2.5% sodium nitrate group (equivalent to 1250 mg/kg bw per day, 910 nitrate ion/kg bw per day), tumour incidence was reported to be 100%, whereas, in male rats from the 5% dose group (equivalent to 2500 mg/kg bw per day, 1820 mg nitrate ion/kg bw per day), the incidence was 96%. All other groups showed lower absolute tumour incidences than controls. The most commonly observed tumour in males was in the testes (interstitial cell) followed by the mammary gland, adrenal gland and liver. Tumours of the mammary gland, pituitary gland, uterus and adrenal gland were the most commonly observed tumours in females. Overall, there was no statistically significant difference of any specific tumour. The time of appearance of the first background tumour was not affected in any treatment group. Only the incidences of tumours of the haematopoietic organs were reported to be statistically significantly lower in the treated groups compared to controls, especially concerning mononuclear cell leukaemia. In conclusion, no adverse effects were observed up to and including the highest dose tested. Sodium nitrate did not have carcinogenic activity in F344 rats when administered continuously for 2 years. In conclusion, no carcinogenic effects were observed and the NOAEL for adverse toxic effects is ≥2500 mg sodium nitrate/kg bw/day, ≥1820 mg nitrate/kg bw/day (highest dose tested). Expert statement: Based on the existing data, read across and current ADI values no relevant toxicity after sub-chronic exposure is expected. Overall, generation of additional sub-chronic oral toxicity data is considered not scientifically justified and the sub-chronic oral toxicity study (90-days) thus waived. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0da721c-5e80-46ed-963a-74b054faf9ea/documents/e091d179-cc37-4f8f-924d-f1e063b890e3_9ca75d8e-c78e-4ffe-a164-38371fc92d39.html,,,,,, Ammonium nitrate,6484-52-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0da721c-5e80-46ed-963a-74b054faf9ea/documents/e091d179-cc37-4f8f-924d-f1e063b890e3_9ca75d8e-c78e-4ffe-a164-38371fc92d39.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,920 mg/kg bw/day,,rat Ammonium nitrate,6484-52-2,"The acute oral and dermal toxicity (LD50) is >2000 and >5000 mg/kg bw, respectively, for ammonium nitrate. The acute inhalation toxicity is not tested. An acute inhalation study is not required due to the low vapour pressure and the high particle size of ammonium nitrate. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0da721c-5e80-46ed-963a-74b054faf9ea/documents/27e9191b-7a76-4660-b036-83cbdf10032f_9ca75d8e-c78e-4ffe-a164-38371fc92d39.html,,,,,, Ammonium nitrate,6484-52-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0da721c-5e80-46ed-963a-74b054faf9ea/documents/27e9191b-7a76-4660-b036-83cbdf10032f_9ca75d8e-c78e-4ffe-a164-38371fc92d39.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Ammonium nitrate,6484-52-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0da721c-5e80-46ed-963a-74b054faf9ea/documents/27e9191b-7a76-4660-b036-83cbdf10032f_9ca75d8e-c78e-4ffe-a164-38371fc92d39.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Ammonium oleate,544-60-5,"The analogue substance 9-octadecenoic acid caused changes in the epidermis, the corium and in hair follicles after repeated applications to the skin of rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe2f3f17-e546-4f18-869a-be2fa0175c39/documents/IUC5-68f9c21b-0eff-4e61-8552-33e8033042ff_71a26254-70d1-4658-be94-13c2591aff8f.html,,,,,, Ammonium oleate,544-60-5,"oral:For an analogue substance a LD50 value of 47.3 mL/kg bw (42097 mg/kg bw) was determined in rats after oral administration.intravenous:After intravenous application, a LD50 of approximately 267 mg/kg bw was determined for the analogue substance. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe2f3f17-e546-4f18-869a-be2fa0175c39/documents/IUC5-f05c023f-beae-4c05-ac3b-ed2f0ae934ed_71a26254-70d1-4658-be94-13c2591aff8f.html,,,,,, Ammonium oleate,544-60-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe2f3f17-e546-4f18-869a-be2fa0175c39/documents/IUC5-f05c023f-beae-4c05-ac3b-ed2f0ae934ed_71a26254-70d1-4658-be94-13c2591aff8f.html,,oral,LD50,"42,097 mg/kg bw",no adverse effect observed, Diammonium peroxodisulphate,7727-54-0," The oral repeated dose toxicity of diammonium persulfate was based on a subacute oral toxicity study and a read across approach from dipotassium persulfate and disodium persulfate, as these substances show similar toxicological properties. A subacute NOAEL of 41.1 mg/kg bw/day and a subchronic NOAEL of 91 mg/kg bw/day were determined. Diammonium persulfate was tested for subchronic inhalation toxicity. A NOAEC value of 10.3 mg/m³ was determined. Repeated dose toxicity via the dermal route was waived for the Persulfate Category. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2718093f-e787-4b97-86a7-709ef6b08fbb/documents/6e7dd716-3670-41b2-92b5-59e9d566924f_428e31bd-4670-48f8-b296-b8471f9e8a29.html,,,,,, Diammonium peroxodisulphate,7727-54-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2718093f-e787-4b97-86a7-709ef6b08fbb/documents/6e7dd716-3670-41b2-92b5-59e9d566924f_428e31bd-4670-48f8-b296-b8471f9e8a29.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,91 mg/kg bw/day,,rat Diammonium peroxodisulphate,7727-54-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2718093f-e787-4b97-86a7-709ef6b08fbb/documents/6e7dd716-3670-41b2-92b5-59e9d566924f_428e31bd-4670-48f8-b296-b8471f9e8a29.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,10.3 mg/m3,,rat Diammonium peroxodisulphate,7727-54-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2718093f-e787-4b97-86a7-709ef6b08fbb/documents/6e7dd716-3670-41b2-92b5-59e9d566924f_428e31bd-4670-48f8-b296-b8471f9e8a29.html,Repeated dose toxicity – local effects,inhalation,NOAEC,10.3 mg/m3,adverse effect observed,rat Diammonium peroxodisulphate,7727-54-0," Diammonium persulfate was tested for acute toxicity via the oral, dermal and inhalation routes in rats. In an acute oral toxicity study LD50 and LD0 values of 742 mg/kg bw and 300 mg/kg bw, respectively, in the male rat and LD50 value of 700 mg/kg bw in the female rat were determined. In an acute dermal toxicity study LD50 and LD0 values of greater than 2000 mg/kg bw and 2000 mg/kg bw  were determined, respectively. In an acute inhalation toxicity study (whole body exposure) LC50 and LC0 values of greater than 2.95 mg/L and 2.95 mg/L, respectively, were determined. Additional studies were available for substances of the Persulfate Category. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2718093f-e787-4b97-86a7-709ef6b08fbb/documents/c7295d3e-7908-441c-9097-cd790b2657e0_428e31bd-4670-48f8-b296-b8471f9e8a29.html,,,,,, Diammonium peroxodisulphate,7727-54-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2718093f-e787-4b97-86a7-709ef6b08fbb/documents/c7295d3e-7908-441c-9097-cd790b2657e0_428e31bd-4670-48f8-b296-b8471f9e8a29.html,,oral,LD50,700 mg/kg bw,adverse effect observed, Diammonium peroxodisulphate,7727-54-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2718093f-e787-4b97-86a7-709ef6b08fbb/documents/c7295d3e-7908-441c-9097-cd790b2657e0_428e31bd-4670-48f8-b296-b8471f9e8a29.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Diammonium peroxodisulphate,7727-54-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2718093f-e787-4b97-86a7-709ef6b08fbb/documents/c7295d3e-7908-441c-9097-cd790b2657e0_428e31bd-4670-48f8-b296-b8471f9e8a29.html,,inhalation,discriminating conc.,"2,950 mg/m3",no adverse effect observed, Ammonium dihydrogenorthophosphate,7722-76-1,"No study with ammonium dihydrogenorthophoshate is present. Based on a reliable oral OECD 422 study with diammonium hydrogenorthophoshate in rats, local effects were observed in the stomach at the lowest dose tested (250 mg/kg bw/day). However, the systemic NOAEL is determined to be 250 mg/kg bw/day based on horizontal banding of dental surface at mid dose (LOAEL), with effects on haematological and clinical chemistry parameters at highest dose level. The read-across rationale can be found in the category approach document attached in IUCLID Section 13 and is fully included in the CSR. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/450dccce-4919-45a8-835f-ba6739743d6e/documents/IUC5-e267d242-fbfd-47a6-a4a5-7f8613f114a2_3901f164-8af7-4cd5-ac4c-04e535051835.html,,,,,, Ammonium dihydrogenorthophosphate,7722-76-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/450dccce-4919-45a8-835f-ba6739743d6e/documents/IUC5-e267d242-fbfd-47a6-a4a5-7f8613f114a2_3901f164-8af7-4cd5-ac4c-04e535051835.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Ammonium dihydrogenorthophosphate,7722-76-1,"Based on reliable studies with ammonium dihydrogenorthophosphate for acute oral and dermal exposure to rats, the oral LD50 is >2000 mg/kg bw and the dermal LD50 is >2000 mg/kg bw. No reliable acute inhalation study is present for the substance. A reliable acute toxicity inhalation study with read across substance diammonium hydrogenorthophosphate shows an LC50 is > 5 mg/L. The read-across rationale can be found in the category approach document attached in Section 13 of IUCLID and is fully incorporated in the CSR. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/450dccce-4919-45a8-835f-ba6739743d6e/documents/IUC5-e1774c73-6ef7-441f-a5d2-250dfce08b94_3901f164-8af7-4cd5-ac4c-04e535051835.html,,,,,, Ammonium dihydrogenorthophosphate,7722-76-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/450dccce-4919-45a8-835f-ba6739743d6e/documents/IUC5-e1774c73-6ef7-441f-a5d2-250dfce08b94_3901f164-8af7-4cd5-ac4c-04e535051835.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ammonium dihydrogenorthophosphate,7722-76-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/450dccce-4919-45a8-835f-ba6739743d6e/documents/IUC5-e1774c73-6ef7-441f-a5d2-250dfce08b94_3901f164-8af7-4cd5-ac4c-04e535051835.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Ammonium dihydrogenorthophosphate,7722-76-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/450dccce-4919-45a8-835f-ba6739743d6e/documents/IUC5-e1774c73-6ef7-441f-a5d2-250dfce08b94_3901f164-8af7-4cd5-ac4c-04e535051835.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Ammonium sulphate,7783-20-2," oral In the subchronic part of the study from Ota et al 2006, groups of 10 rats/sex were fed a diet containing the test substance (purity not given) at concentrations of 0, 0.1, 0.6, or 3% for 1 year. These concentrations corresponded to average daily intakes of 0, 42, 256, and 1527 mg/kg bw/d for males and 0, 48, 284, and 1490 mg/kg bw/d for females, respectively. For investigation of the carcinogenic potential, groups of 50 rats/sex were fed a diet containing the test substance (purity not given) at concentrations of 0, 1.5, or 3% for 2 years. These concentrations corresponded to average daily intakes of 0, 564.1, and 1288.2 mg/kg bw/d for males and 0, 649.9, and 1371.4 mg/kg bw/d for females respectively. Absolute and relative kidney weights were increased at the high dose level for both sexes. Absolute spleen weights were decreased and relative liver weights were increased in high dose males. No macroscopic changes were recorded by gross pathology, except for massive nodular or focal lesions suggesting neoplastic changes. At histopathological examination, non-neoplastic and neoplastic lesions were noted in the control and treatment groups, with no significant inter-group difference in their incidences or severity. The authors concluded that the NOAEL of ammonium sulfate was 256 and 284 mg/kg bw/d in males and females, respectively, and the compound is noncarcinogenic under the conditions of the study. Inhalation A 14-day inhalation study on rats exposed to 300 mg/m³, the only tested dose, did not report histopathological changes in the lower respiratory tract. As the respiratory tract is the target organ for inhalation exposure, the NOEL for toxicity to the lower respiratory tract is 300 mg/m³(Pepelko, Mattox and Cohen, 1980). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9e3ae7b-f01d-4ad3-823f-8a2244bb69b4/documents/IUC5-e9bf2e9c-9bc8-4a97-81c2-83f975354898_85ca7227-80bb-431a-af8d-4fe7e88b9821.html,,,,,, Ammonium sulphate,7783-20-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9e3ae7b-f01d-4ad3-823f-8a2244bb69b4/documents/IUC5-e9bf2e9c-9bc8-4a97-81c2-83f975354898_85ca7227-80bb-431a-af8d-4fe7e88b9821.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,300 mg/m3,,rat Ammonium sulphate,7783-20-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9e3ae7b-f01d-4ad3-823f-8a2244bb69b4/documents/IUC5-e9bf2e9c-9bc8-4a97-81c2-83f975354898_85ca7227-80bb-431a-af8d-4fe7e88b9821.html,Chronic toxicity – systemic effects,oral,NOAEL,256 mg/kg bw/day,,rat Ammonium sulphate,7783-20-2," Ammonium sulfate is of relatively low acute toxicity (LD50, oral, rat: 2000 - 4250 mg/kg bw; LD50 dermal, rat/mouse > 2000 mg/kg bw; 8-h LC50, inhalation, rat > 1000 mg/m³). Clinical signs after oral exposure included staggering, prostration, apathy, and laboured and irregular breathing immediately after dosing at doses near to or exceeding the LD50 value. In humans, inhalation exposure to 0.1 - 0.5 mg ammonium sulfate/m³ aerosol for two to four hours produced no pulmonary effects. At 1 mg ammonium sulfate/m³ very slight pulmonary effects in the form of a decrease in expiratory flow, in pulmonary flow resistance and dynamic lung compliance were found in healthy volunteers after acute exposure. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9e3ae7b-f01d-4ad3-823f-8a2244bb69b4/documents/IUC5-4cfc3442-ff09-4cfc-a8e5-46d0333fbdca_85ca7227-80bb-431a-af8d-4fe7e88b9821.html,,,,,, Ammonium sulphate,7783-20-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9e3ae7b-f01d-4ad3-823f-8a2244bb69b4/documents/IUC5-4cfc3442-ff09-4cfc-a8e5-46d0333fbdca_85ca7227-80bb-431a-af8d-4fe7e88b9821.html,,oral,LD50,"4,250 mg/kg bw",adverse effect observed, Ammonium sulphate,7783-20-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9e3ae7b-f01d-4ad3-823f-8a2244bb69b4/documents/IUC5-4cfc3442-ff09-4cfc-a8e5-46d0333fbdca_85ca7227-80bb-431a-af8d-4fe7e88b9821.html,,dermal,LD50,"2,000 mg/kg bw",, Ammonium sulphate,7783-20-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9e3ae7b-f01d-4ad3-823f-8a2244bb69b4/documents/IUC5-4cfc3442-ff09-4cfc-a8e5-46d0333fbdca_85ca7227-80bb-431a-af8d-4fe7e88b9821.html,,inhalation,LC50,"1,000 mg/m3",no adverse effect observed, Ammonium sulphite,10196-04-0,"A 3-generation chronic toxicity study (Til et al. 1972a) with treatment of rats (20 per sex and group) with dose levels of 0, 0.125, 0.25, 0.5, 1.0 or 2.0% Na2S2O5 administered in a 50 ppm thiamine-containing diet was identified as most reliable study for repeated dose toxicity and was defined as key study (read-across info, see `discussion`). Based on the read across concept for the group of sulfite substances, this result is also applicable to ammonium sulfite. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ddc1883-d972-4f0e-af07-f3e10aaf58b9/documents/IUC5-1c43acdd-5757-4f2e-bb51-05b3134931ac_0a1ce8ab-bfd7-40d9-961a-a09514c0f92d.html,,,,,, Ammonium sulphite,10196-04-0,"Based on the described read-across methodology information from sodium sulfite (CAS 7757-83-7), sodium metabisulfite (CAS 7681 -57 -4) and potassium metabisulfite (CAS 16731 -55 -8) were used to determine acute toxicity values (oral, dermal and inhalative) for ammonium sulfite.Please see `discussion` below. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ddc1883-d972-4f0e-af07-f3e10aaf58b9/documents/IUC5-d6fc2616-acf2-4b87-b484-8a170dbc786a_0a1ce8ab-bfd7-40d9-961a-a09514c0f92d.html,,,,,, Ammonium thiocyanate,1762-95-4,There is one acceptable study report available on a 90-day study in rats performed with ammonium thiocyanate according to OECD408 and GLP. Mortality was observed at 500 mg/kg bw per day. At 100 mg/kg bw signs of toxicity include changes in haematological and clinical chemistry parameters. The NOAEL is 20 mg NH4SCN/kg bw/day. (Equal to 15.3 mg SCN-/kg bw/day) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54972465-9393-4d8d-93b3-ea03fb0c4fcb/documents/IUC5-8d9e64ee-4a46-45c6-b337-151272319b36_05c4746e-80d6-4210-b49b-c4fcfa376bde.html,,,,,, Ammonium thiocyanate,1762-95-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54972465-9393-4d8d-93b3-ea03fb0c4fcb/documents/IUC5-8d9e64ee-4a46-45c6-b337-151272319b36_05c4746e-80d6-4210-b49b-c4fcfa376bde.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat Ammonium thiocyanate,1762-95-4,"They key value from acute oral toxicity is derived from a study with ammonium thiocyanate in Japanese quails (OECD 401, GLP), LD50 508 mg/kg bw.A guideline acute dermal study with ammonium thiocyanate is not available. In an acute dermal toxicity study with potassium thiocyanate no mortalities occurred and the LD50 is >2000 mg/kg bw.An acute inhalation study is not available but inhalation is not a likely route of exposure due to the low vapour pressure, hygroscopic properties of the substance and the way of use. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54972465-9393-4d8d-93b3-ea03fb0c4fcb/documents/IUC5-989618a4-39c4-4716-b6f0-a0af433dcddd_05c4746e-80d6-4210-b49b-c4fcfa376bde.html,,,,,, Ammonium thiocyanate,1762-95-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54972465-9393-4d8d-93b3-ea03fb0c4fcb/documents/IUC5-989618a4-39c4-4716-b6f0-a0af433dcddd_05c4746e-80d6-4210-b49b-c4fcfa376bde.html,,oral,LD50,508 mg/kg bw,adverse effect observed, Ammonium thiocyanate,1762-95-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54972465-9393-4d8d-93b3-ea03fb0c4fcb/documents/IUC5-989618a4-39c4-4716-b6f0-a0af433dcddd_05c4746e-80d6-4210-b49b-c4fcfa376bde.html,,dermal,discriminating dose,"2,000 mg/kg bw",adverse effect observed, Ammonium mercaptoacetate,5421-46-5,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyInformation.KeyInformation): No reliable data is available on the repeated dose toxicity of ammonium thioglycolate. However, the subchronic toxicity of sodium thioglycolate was evaluated by oral and dermal administrations. In an oral repeated dose toxicity study (OECD 408), sodium mercaptoacetate was administered by gavage, 7 days/week, for 13 weeks, to male and female Sprague-Dawley rats. Sporadic mortality and fully reversible effects on some haematological and biochemical parameters and histopathological changes in liver were observed at 60 mg/kg bw/d. These effects may be related to the inhibition of the β-oxidation of fatty acids a known mechanism of action of sodium mercaptoacetate. Consequently, based on the effects observed at 60 mg a. i. /kg/day, particularly mortality, hematological and significant blood chemistry changes associated with liver microscopic changes and the limited blood chemistry effects without microscopic adverse changes in the liver observed at 20 mg a. i. /kg/day, the NOAEL of sodium mercaptoacetate was 20 mg a. i. /kg/day, and the NOEL was 7 mg a. i. /kg/day given by daily oral administration (gavage) to rats for 13 weeks. Additional information on the oral repeated dose toxicity of sodium mercaptoacetate is provided by the 2-generation reprotoxicity study (OECD 416) study and the reproduction/developmental screening test (OECD 421). The results of both studies support the NOAEL 20 mg a. i. /kg/day defined in the 13-week toxicity study. In a repeated dose dermal toxicity (OECD 411), sodium mercaptoacetate was administered via dermal route, 5 days per week, for 13 weeks to male and female Fischer 344 rats and B6C3F1 mice. All animals survived the 13 weeks administration. The only treatment related effect was skin irritation at the site of application. The LOELs for skin irritation were 11.25 and 45 mg/kg bw/d and the NOAELs for systemic toxicity were higher than 180 and 360 mg/kg bw/d in rats and mice, respectively.Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): adequate and valid ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ebfea59-9d40-4073-9e7f-a32f7c57170b/documents/9ca427de-48b0-4f51-bacf-0ccfe616cf4e_937bdfac-edfd-4f0f-9f29-a9387c9307bc.html,,,,,, Ammonium mercaptoacetate,5421-46-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ebfea59-9d40-4073-9e7f-a32f7c57170b/documents/9ca427de-48b0-4f51-bacf-0ccfe616cf4e_937bdfac-edfd-4f0f-9f29-a9387c9307bc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,19 mg/kg bw/day,,rat Ammonium mercaptoacetate,5421-46-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ebfea59-9d40-4073-9e7f-a32f7c57170b/documents/9ca427de-48b0-4f51-bacf-0ccfe616cf4e_937bdfac-edfd-4f0f-9f29-a9387c9307bc.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,172 mg/kg bw/day,,rat Ammonium mercaptoacetate,5421-46-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ebfea59-9d40-4073-9e7f-a32f7c57170b/documents/9ca427de-48b0-4f51-bacf-0ccfe616cf4e_937bdfac-edfd-4f0f-9f29-a9387c9307bc.html,Repeated dose toxicity – local effects,dermal,LOAEL,63 ,adverse effect observed, Ammonium mercaptoacetate,5421-46-5,Ammonium thioglycolate is toxic if swallowed (Acute Tox 3). ATG is non-toxic by the percutaneous route. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ebfea59-9d40-4073-9e7f-a32f7c57170b/documents/IUC5-9afc7dbd-ac79-4ac8-8d3c-154289550616_937bdfac-edfd-4f0f-9f29-a9387c9307bc.html,,,,,, Ammonium mercaptoacetate,5421-46-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ebfea59-9d40-4073-9e7f-a32f7c57170b/documents/IUC5-9afc7dbd-ac79-4ac8-8d3c-154289550616_937bdfac-edfd-4f0f-9f29-a9387c9307bc.html,,oral,LD50,100 mg/kg bw,adverse effect observed, Ammonium mercaptoacetate,5421-46-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ebfea59-9d40-4073-9e7f-a32f7c57170b/documents/IUC5-9afc7dbd-ac79-4ac8-8d3c-154289550616_937bdfac-edfd-4f0f-9f29-a9387c9307bc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ammonium 2-mercaptopropionate,13419-67-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b641beed-63c5-46ed-a2fe-9fdc85e9e7dd/documents/a2ee54dd-70ea-46a1-888f-1d5881113826_b1e10bef-2553-4955-bd7e-57c8e78aa0da.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat Ammonium 2-mercaptopropionate,13419-67-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b641beed-63c5-46ed-a2fe-9fdc85e9e7dd/documents/308bda3a-18b2-422e-9ed6-dd642490ccd5_b1e10bef-2553-4955-bd7e-57c8e78aa0da.html,,oral,LD50,"1,518 mg/kg bw",adverse effect observed, Ammonium 2-mercaptopropionate,13419-67-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b641beed-63c5-46ed-a2fe-9fdc85e9e7dd/documents/308bda3a-18b2-422e-9ed6-dd642490ccd5_b1e10bef-2553-4955-bd7e-57c8e78aa0da.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, Ammonium trioxovanadate,7803-55-6,"Description of key information - soluble vanadium substances group (oral) A comprehensive literature search was recently conducted for the vanadium category substances, to source relevant information for the hazard and risk assessment. For the group of the soluble vanadium substances, a limited number of studies is available, and the different experimental approaches lead to a variety of endpoints measured. Of the limited effects noted following oral exposure with soluble vanadium substances, it appears most likely that effects on haematological parameters are the most consistently reported among a number of investigators (Mountain et al 1953, Zaporowska et al. 1993, Scibior et al 2006, Scibior, 2005, NTP, 2002, NTP, 2023). Altogether, haematological effects have been found with a variety of different vanadium compounds including sodium metavanadate, vanadium pentoxide, and ammonium metavanadate supporting the use of this endpoint for risk assessment purposes. Furthermore, epithelial hyperplasia in the small intestine of rats and mice were observed after the administration of sodium metavanadate and vanadyl sulfate (NTP, 2023). Therefore, this endpoint should also be considered for risk assessment purposes. Information on repeated dose toxicity following inhalation exposure to divanadium pentaoxide is available in a NTP study (k_NTP 2002) with exposure of male and female rats and mice to V2O5 over 16-days, 3-months and 2-years. Pulmonary reactivity to divanadium pentaoxide was also investigated following subchronic inhalation exposure in a non-human primate animal model. Data of the repeated-dose toxicity via the dermal route are not available for any vanadium substance. Following the HERAG guidance for metals and metal salts (see section 7.1.2 of the technical dossier: dermal absorption), negligible percutaneous uptake based on minimal penetration, i.e. a dermal absorption rate in the range of maximally 0.1 - 1.0 %, can be anticipated. Dermal absorption in this order of magnitude is not considered to be “significant”. Thus, regarding repeated-dose toxicity of vanadium substances, the dermal exposure route is not expected to be the most relevant. EBRC (2007) HERAG fact sheet - Assessment of occupational dermal exposure and dermal absorption for metals and inorganic metal compounds, EBRC Consulting GmbH, Hannover, Germany, August 2007, 49 pages.   Further information: Divanadium pentaoxide has been excluded from the soluble vanadium substances read-across group due to its legal classification. Thus, studies conducted with divanadium pentaoxide are reported for information purposes only. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4a788ea-f9e3-4fe6-a2ee-5ba903aa0473/documents/IUC5-f5c2d8b3-28cf-449e-ade5-b6134c32ed89_6ec5196e-30aa-4746-8dc4-6c6f9177473b.html,,,,,, Ammonium trioxovanadate,7803-55-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4a788ea-f9e3-4fe6-a2ee-5ba903aa0473/documents/IUC5-f5c2d8b3-28cf-449e-ade5-b6134c32ed89_6ec5196e-30aa-4746-8dc4-6c6f9177473b.html,Repeated dose toxicity – local effects,inhalation,LOAEC,0.64 mg/m3,adverse effect observed,rat Ammonium trioxovanadate,7803-55-6," Acute oral toxicity: LD50 = 141.4 mg/kg bw (OECD 401; GLP; female rats) Acute inhalation toxicity: LC50 = 2.4 mg/L air (analytical) (OECD 403; GLP, female rats) Acute dermal toxicity: LD50 > 2500 mg/kg bw (OECD 402; GLP) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4a788ea-f9e3-4fe6-a2ee-5ba903aa0473/documents/IUC5-5e318393-c74c-4f86-aea4-bd4ec98f57c1_6ec5196e-30aa-4746-8dc4-6c6f9177473b.html,,,,,, Ammonium trioxovanadate,7803-55-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4a788ea-f9e3-4fe6-a2ee-5ba903aa0473/documents/IUC5-5e318393-c74c-4f86-aea4-bd4ec98f57c1_6ec5196e-30aa-4746-8dc4-6c6f9177473b.html,,oral,LD50,141.4 mg/kg bw,adverse effect observed, Ammonium trioxovanadate,7803-55-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4a788ea-f9e3-4fe6-a2ee-5ba903aa0473/documents/IUC5-5e318393-c74c-4f86-aea4-bd4ec98f57c1_6ec5196e-30aa-4746-8dc4-6c6f9177473b.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, Ammonium trioxovanadate,7803-55-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4a788ea-f9e3-4fe6-a2ee-5ba903aa0473/documents/IUC5-5e318393-c74c-4f86-aea4-bd4ec98f57c1_6ec5196e-30aa-4746-8dc4-6c6f9177473b.html,,inhalation,LC50,"2,430 mg/m3",adverse effect observed, Pentan-1-ol,71-41-0,Repeated dose toxicity:   The oral NOAEL was found to be 1000 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/674d3bbf-9778-49ec-b59f-56d5fd1954a9/documents/IUC5-ac86d0c0-c4f4-42d7-8099-cd43fb7aa4fa_63e8debb-fde8-4a54-af43-c4c1b8a84cfb.html,,,,,, Pentan-1-ol,71-41-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/674d3bbf-9778-49ec-b59f-56d5fd1954a9/documents/IUC5-ac86d0c0-c4f4-42d7-8099-cd43fb7aa4fa_63e8debb-fde8-4a54-af43-c4c1b8a84cfb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Pentan-1-ol,71-41-0,"oral:   all the LD50 values of the test substance and category members were found to be greater than 2000 mg/kg bw.   inhalation:   No mortalities occured when pentan-1-ol or the read-across substances were applied as vapour. In a study conducted on a read-across substance which was applied as an aerosol, the LC50 in mice was found to be <14 mg/L.   dermal:   All the dermal LD50 value were found to be greater than 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/674d3bbf-9778-49ec-b59f-56d5fd1954a9/documents/IUC5-9e58f2b3-b487-49f0-aa12-c0ad358cfb28_63e8debb-fde8-4a54-af43-c4c1b8a84cfb.html,,,,,, Pentan-1-ol,71-41-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/674d3bbf-9778-49ec-b59f-56d5fd1954a9/documents/IUC5-9e58f2b3-b487-49f0-aa12-c0ad358cfb28_63e8debb-fde8-4a54-af43-c4c1b8a84cfb.html,,oral,LD50,"3,645 mg/kg bw",adverse effect observed, Pentan-1-ol,71-41-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/674d3bbf-9778-49ec-b59f-56d5fd1954a9/documents/IUC5-9e58f2b3-b487-49f0-aa12-c0ad358cfb28_63e8debb-fde8-4a54-af43-c4c1b8a84cfb.html,,dermal,LD50,"2,292 mg/kg bw",adverse effect observed, Pentan-1-ol,71-41-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/674d3bbf-9778-49ec-b59f-56d5fd1954a9/documents/IUC5-9e58f2b3-b487-49f0-aa12-c0ad358cfb28_63e8debb-fde8-4a54-af43-c4c1b8a84cfb.html,,inhalation,discriminating conc.,"14,000 mg/m3",no adverse effect observed, Octan-3-one,106-68-3," Acute toxicity, Oral (similar to OECD 401): LD50 5000mg/kg bw Acute toxicity, Dermal (similar to OECD 402): LD50 >5000mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09c8b651-f31f-46b0-8b20-5cbcbab2acb1/documents/50f2c471-6d03-4878-948f-391017173d83_0d7ee86e-6261-48ec-a15d-a146666fe30e.html,,,,,, Octan-3-one,106-68-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09c8b651-f31f-46b0-8b20-5cbcbab2acb1/documents/50f2c471-6d03-4878-948f-391017173d83_0d7ee86e-6261-48ec-a15d-a146666fe30e.html,,oral,LD50,"5,000 mg/kg bw",adverse effect observed, Pentyl formate,638-49-3, Acute oral toxicity: LD50 was considered to be > 2000 mg/kg bw when rat were treated with Pentyl formate orally. Acute dermal toxicity: LD50 was considered to be > 2000 mg/kg bw when rabbits were treated with Pentyl formate dermally. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2d8a093-8222-4150-bb37-d591a87f1291/documents/e51ffa77-c1f7-464f-b0cb-813ccefd8ead_8623adaa-982b-401d-801d-0d4f8f4c98f2.html,,,,,, Pentyl formate,638-49-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2d8a093-8222-4150-bb37-d591a87f1291/documents/e51ffa77-c1f7-464f-b0cb-813ccefd8ead_8623adaa-982b-401d-801d-0d4f8f4c98f2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Pentyl formate,638-49-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2d8a093-8222-4150-bb37-d591a87f1291/documents/e51ffa77-c1f7-464f-b0cb-813ccefd8ead_8623adaa-982b-401d-801d-0d4f8f4c98f2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Pentyl phenylacetate,5137-52-0," Repeated dose toxicity: Oral Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for pentyl 2-phenylacetate. The study assumed the use of male and female Wistar rats in a 8 week toxicity study. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Level (NOAEL) for pentyl 2-phenylacetate is predicted to be 1061.904785156 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. Repeated dose toxicity: Inhalation pentyl 2-phenylacetate has very low vapor pressure (0.0029852451 mm Hg), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated inhalation toxicity was considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value for pentyl 2-phenylacetate (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not irritating and not sensitizing to the skin. Based on these considerations, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6421fa7-2e02-41ea-a1c9-7685e7082dd9/documents/9e2fe6a5-e8f7-4335-857e-fd2ed6753d37_553f8f5b-cef4-42e8-989c-3d59eecd5de4.html,,,,,, Pentyl phenylacetate,5137-52-0,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6421fa7-2e02-41ea-a1c9-7685e7082dd9/documents/9e2fe6a5-e8f7-4335-857e-fd2ed6753d37_553f8f5b-cef4-42e8-989c-3d59eecd5de4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,061.905 mg/kg bw/day",,rat Pentyl phenylacetate,5137-52-0," Acute oral toxicity LD50 was estimated to be 3874mg/kg bw, when male and female Spartan rats were exposed with pentyl 2-phenylacetate (5137-52-0) orally. Acute inhalation toxicity: Reactive Orange 013 has very low vapor pressure (0.0029852451 mm Hg), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for acute inhalation toxicity was considered for waiver. Acute dermal toxicity LD50 was estimated to be 3178 mg/kg bw, when male and female New Zealand White rabbits were exposed with pentyl 2-phenylacetate (5137-52-0) by dermal application. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6421fa7-2e02-41ea-a1c9-7685e7082dd9/documents/930f3d1e-f875-40b0-abe0-2a452c4b2c6c_553f8f5b-cef4-42e8-989c-3d59eecd5de4.html,,,,,, Pentyl phenylacetate,5137-52-0,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6421fa7-2e02-41ea-a1c9-7685e7082dd9/documents/930f3d1e-f875-40b0-abe0-2a452c4b2c6c_553f8f5b-cef4-42e8-989c-3d59eecd5de4.html,,oral,LD50,"3,874 mg/kg bw",no adverse effect observed, Pentyl phenylacetate,5137-52-0,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6421fa7-2e02-41ea-a1c9-7685e7082dd9/documents/930f3d1e-f875-40b0-abe0-2a452c4b2c6c_553f8f5b-cef4-42e8-989c-3d59eecd5de4.html,,dermal,LD50,"3,178 mg/kg bw",no adverse effect observed, Pentyl propionate,624-54-4,"There is a 28-day repeated dose inhalation study in rats for n-pentyl propionate and along with a 2 -week oral range finder (females only) but no repeated dose dermal study available. In addition, there are several repeated dose inhalation studies ranging from 9 days to 90 days in duration for the other substances in the category, n-propyl propionate and n-butyl propionate refer to the justification for read across attached to section 13 of the dataset). The only common finding across all the studies has been histopathologic changes in the nasal tissues (olfactory epithelium damage) and this can be considered to be a local effect, while again across all the studies there have been no major indications of any systemic toxicity up to the highest doses tested. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18c3ad0e-fd87-49af-bf39-16116ec5f9ef/documents/IUC5-436b618b-9f51-450e-8661-c08684a3b665_f8f7d191-7630-48be-961e-0f19a2c65703.html,,,,,, Pentyl propionate,624-54-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18c3ad0e-fd87-49af-bf39-16116ec5f9ef/documents/IUC5-436b618b-9f51-450e-8661-c08684a3b665_f8f7d191-7630-48be-961e-0f19a2c65703.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"8,111 mg/m3",,rat Pentyl propionate,624-54-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18c3ad0e-fd87-49af-bf39-16116ec5f9ef/documents/IUC5-436b618b-9f51-450e-8661-c08684a3b665_f8f7d191-7630-48be-961e-0f19a2c65703.html,Repeated dose toxicity – local effects,inhalation,NOAEC,683.157 mg/m3,adverse effect observed,rat Pentyl propionate,624-54-4,"Acute oral - In a non-GLP study conducted with study methodology equivalent to OECD TG 401, the LD50 value of pentyl propionate to male and female Sprague Dawley rats was > 16 ml/kg (Conversion from ml/kg to mg/kg resulted in - 16 ml/kg - 13920 mg/kg (based on density of 0.87)).Acute dermal - In a non-GLP study conducted with study methodology equivalent to OECD TG 402, the acute dermal LD50 value of pentyl propionate to male and female New Zealand rabbits was > 16 ml/kg (Conversion from ml/kg to mg/kg resulted in - 16 ml/kg - 13920 mg/kg (based on density of 0.87)). Acute inhalation - In a non-GLP study conducted with study methodology equivalent to OECD TG 403, the acute inhalation LC50 value of pentyl propionate to male and female Sprague Dawley rats exposed to saturated vapors over a period of 6 hours was 10070 mg/m3 or 10.07 mg/l (based on conversion). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18c3ad0e-fd87-49af-bf39-16116ec5f9ef/documents/IUC5-c5030163-44cd-47ef-9974-fd02638cd794_f8f7d191-7630-48be-961e-0f19a2c65703.html,,,,,, 2-diethoxymethyl-1-phenylhept-1-ene,60763-41-9,Acute oral toxicity: OECD TG 401: > 5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8822572d-dcf2-42e2-a61b-b695ae57a704/documents/b5349003-fd0c-4824-a63e-a66e80d405a5_e6cf2569-5f79-4fd9-8e62-b8e795d6b637.html,,,,,, 2-pentylcyclopentan-1-one,4819-67-4,"Repeated dose toxicity oral: NOAEL = 683 mg/kg bw/day in female rats; NOAEL = 704 mg/kg bw/day in male rats (OECD 422, K, rel. 2, read-across). Absence of significant effects that could be considered to be adverse at the highest dose tested and below. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a8d3a55-8863-48f5-a7ff-52f53ab10eb2/documents/IUC5-61f5d9b8-7259-45fb-91b7-7571890902bf_7eab47f7-1f08-466e-9930-f498980a47ce.html,,,,,, 2-pentylcyclopentan-1-one,4819-67-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a8d3a55-8863-48f5-a7ff-52f53ab10eb2/documents/IUC5-61f5d9b8-7259-45fb-91b7-7571890902bf_7eab47f7-1f08-466e-9930-f498980a47ce.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,683 mg/kg bw/day,,rat 2-pentylcyclopentan-1-one,4819-67-4,"Acute toxicity: oral: LD50 > 5000 mg/kg bw (similar to OECD 401 in rats, K, rel.2);Acute toxicity: dermal: LD50 > 2000 mg/kg bw (similar to OECD 402 in rabbits, K, rel.2);Acute toxicity: inhalation: waiver. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a8d3a55-8863-48f5-a7ff-52f53ab10eb2/documents/IUC5-6fa288c9-18a0-4247-9c0d-a3637aefa2e3_7eab47f7-1f08-466e-9930-f498980a47ce.html,,,,,, 2-pentylcyclopentan-1-one,4819-67-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a8d3a55-8863-48f5-a7ff-52f53ab10eb2/documents/IUC5-6fa288c9-18a0-4247-9c0d-a3637aefa2e3_7eab47f7-1f08-466e-9930-f498980a47ce.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-pentylcyclopentan-1-one,4819-67-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a8d3a55-8863-48f5-a7ff-52f53ab10eb2/documents/IUC5-6fa288c9-18a0-4247-9c0d-a3637aefa2e3_7eab47f7-1f08-466e-9930-f498980a47ce.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-pentylcyclopent-2-en-1-one,25564-22-1,"In a reliable study, the acute oral toxicity test of Pentyl Cyclopentenone FAB was determined to be between 2.0 and 5.0 mL/kg bw. No acute dermal or inhalation studies were available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ce414d9-7a48-46cd-a052-8940e1221382/documents/IUC5-ce811168-882a-4342-bbf0-06feadb14f1b_c5ec7af9-ea06-4bb7-a656-f8b4bc17b502.html,,,,,, 2-pentylcyclopent-2-en-1-one,25564-22-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ce414d9-7a48-46cd-a052-8940e1221382/documents/IUC5-ce811168-882a-4342-bbf0-06feadb14f1b_c5ec7af9-ea06-4bb7-a656-f8b4bc17b502.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amylase, gluco-",9032-08-0," The repeated dose oral toxicity of glucoamylase has been tested, while the repeated dose inhalation and dermal toxicity were waived based on exposure considerations and the properties of the substance. - The repeated dose oral toxicity was a subchronic toxicity test conducted according to OECD guideline 408, and in compliance with GLP. It was concluded that the No Observed Adverse Effect Level (NOAEL) in rats was the highest dose level tested, 1519.2 mg enzyme concentrate dry matter/kg bw/day. - The dermal study was waived because of the low likelihood of absorption of enzymes through the skin due to the physico-chemical properties of the enzyme protein. - The inhalation study was waived because exposure is too low to exert any toxicity. Potential exposure by inhalation to an amount of enzyme that toxicologically relevant is unrealistic, due to the formulation of enzymes and the stringent work practices, enforced because of the risk of sensitisation by inhalation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/352fbd03-a36a-4fe6-9677-632265bc1978/documents/IUC5-21cd8921-4b63-4989-aa05-9b666e267bef_ddcb8750-b287-42b9-8f6d-9a2666eb36df.html,,,,,, "Amylase, gluco-",9032-08-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/352fbd03-a36a-4fe6-9677-632265bc1978/documents/IUC5-21cd8921-4b63-4989-aa05-9b666e267bef_ddcb8750-b287-42b9-8f6d-9a2666eb36df.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,470 mg/kg bw/day",,rat "Amylase, gluco-",9032-08-0," The acute oral toxicity of glucoamylase has been tested, while the acute inhalation and dermal toxicity was regarded as scientifically unjustified. The acute oral toxicity was a short-term toxicity test conducted according to OECD guideline, and in compliance with GLP. The conclusion is that glucoamylase is non-toxic by oral exposure (GHS Toxicity category V). Acute toxicity via the inhalation and dermal route is waived based on exposure considerations and the known properties of the substance. Based on weight of evidence, glucoamylase does not exert any acute dermal or inhalation toxicity under foreseeable realistic exposure levels for both workers and consumers. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/352fbd03-a36a-4fe6-9677-632265bc1978/documents/IUC5-646e9b79-4be3-41fd-8368-097e7b711fe6_ddcb8750-b287-42b9-8f6d-9a2666eb36df.html,,,,,, "Amylase, gluco-",9032-08-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/352fbd03-a36a-4fe6-9677-632265bc1978/documents/IUC5-646e9b79-4be3-41fd-8368-097e7b711fe6_ddcb8750-b287-42b9-8f6d-9a2666eb36df.html,,oral,LD50,"1,996.3 mg/kg bw",no adverse effect observed, "Amyris balsamifera, ext.",90320-49-3, Acute oral toxicity (similar to OECD TG 401): LD50 >5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f989c416-33a8-4366-be12-e975ecdd30c4/documents/9cca0af7-c5ac-40ac-ab39-1744c06f167f_dae5f7c0-1e0a-4655-acb0-cda0ba818f87.html,,,,,, "Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled",8007-24-7,"Administration of Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) by once daily oral gavage for 90 days did not result in adverse effects in rats at levels of 50 and 150 mg/kg bw/day. Histopathological examinations showed, epithelial hyperplasia of the non-glandular mucosa of the stomach (forestomach, squamous mucosa) at 50, 150 and 500 mg/kg bw/day in males and females with a dose-related increase in severity, up to marked in males and moderate in females. At 150 and 500 mg/kg bw/day this correlated with macroscopically irregular stomach surfaces. These findings at 500 mg/kg bw/day were interpreted to be adverse due to the overall severity and concurrent presence of ulceration in some animals. Furthermore, a lower body weight gain was observed in males at 500 mg/kg bw/day which was also considered to be adverse. Other test substance-related changes in clinical signs, body weight, clinical pathology, organ weights and histopathology were considered non-adverse. In the study, no toxicologically relevant treatment related changes in T3 or T4 were evident in either males or females. An increase of TSH was observed in males at 150 and 500 mg/kg bw/day and females at 500 mg/kg bw/day. However, there was considerable variability in the responses observed within the groups and these were largely within the upper 95%ile of the historical control data. This change was associated with the limited extent of diverse follicular cell hypertrophy in the thyroid gland of males and females. These changes were, in most instances, minimal in severity, with the exception of a few males in the higher test doses (where changes of mild severity were observed) and were not degenerative in nature. Follicular cell hypertrophy of the thyroid gland at a low level is common background finding in rats of the strain and age used in the study. No statistically significant effects on the absolute or relative weights of organs potentially sensitive to endocrine disruptors were evident at any of the test doses. Based on the results generated a No Observed Adverse Effect Level (NOAEL) for the systemic toxicity of Cashew Nutshell Extract, Decarboxylated, Distilled (Distilled Grade) of 150 mg/kg bw/day was established. This NOAEL also provides protection against the observed local effects on stomach morphology due to the known irritancy of the test substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4ec8896-ea5d-4da1-bbf3-8d60e7acf265/documents/IUC5-8d441193-024f-45f3-990b-2fd7ee4f2f7b_8f753da8-81fb-48dd-9609-163d2161b07a.html,,,,,, "Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled",8007-24-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4ec8896-ea5d-4da1-bbf3-8d60e7acf265/documents/IUC5-8d441193-024f-45f3-990b-2fd7ee4f2f7b_8f753da8-81fb-48dd-9609-163d2161b07a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled",8007-24-7,"The substance is not expected to show acute toxicity effect by the oral, inhalation and dermal route.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4ec8896-ea5d-4da1-bbf3-8d60e7acf265/documents/IUC5-1e6bbc6d-c7a8-44af-a537-ed7d8f7af7e4_8f753da8-81fb-48dd-9609-163d2161b07a.html,,,,,, "Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled",8007-24-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4ec8896-ea5d-4da1-bbf3-8d60e7acf265/documents/IUC5-1e6bbc6d-c7a8-44af-a537-ed7d8f7af7e4_8f753da8-81fb-48dd-9609-163d2161b07a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled",8007-24-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4ec8896-ea5d-4da1-bbf3-8d60e7acf265/documents/IUC5-1e6bbc6d-c7a8-44af-a537-ed7d8f7af7e4_8f753da8-81fb-48dd-9609-163d2161b07a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-methoxybenzyl alcohol,105-13-5," Repeated dose toxicity: via oral route; NOAEL was considered to be in a dose range of  125-625  mg/kg bw  when rodents  were exposed daily to test substance by oral route for repeated dose study. Repeated inhalation study: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 4-methoxybenzyl alcohol (105-13-5 )which is reported as 0.001799398 mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical 4-methoxybenzyl alcohol is highly unlikely. Therefore this study is considered for waiver. Repeated dermal study; The test substance was evaluated for its repeated dose dermal toxicity study in rabbits for 13 weeks. The test material was exposed to abraded skin of rabbits in the concentration of 0.06mg/Kg for 13 weeks. The animals were observed for clinical sign, mortality, gross and histopathology. Dermal irritation was observed in animals. Somnolence (general depressed activity) was also observed. Therefore LOAEL was considered to be 0.06mg/Kg in rabbits for 13 weeks by dermal exposure. As it is a single dose study and no significant effect were observed. The test substance cannot be classified as per CLP for repeated dose toxicity. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/326bc2a2-b6de-4e86-b729-835757810153/documents/207bb9f6-5dad-4216-88ec-7c4ec8b1b4e4_d46e3ffe-5815-4167-8c7c-b6f91f8a8342.html,,,,,, 4-methoxybenzyl alcohol,105-13-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/326bc2a2-b6de-4e86-b729-835757810153/documents/207bb9f6-5dad-4216-88ec-7c4ec8b1b4e4_d46e3ffe-5815-4167-8c7c-b6f91f8a8342.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat 4-methoxybenzyl alcohol,105-13-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/326bc2a2-b6de-4e86-b729-835757810153/documents/207bb9f6-5dad-4216-88ec-7c4ec8b1b4e4_d46e3ffe-5815-4167-8c7c-b6f91f8a8342.html,Sub-chronic toxicity – systemic effects,dermal,LOAEL,0.06 mg/kg bw/day,,rabbit 4-methoxybenzyl alcohol,105-13-5," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the given test chemical. The LD50 value is 1200 mg/kg bw. The study concluded that the LD50 value is between 300 - 2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0018 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The LD50 value is 3000 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/326bc2a2-b6de-4e86-b729-835757810153/documents/bad48868-d22e-490e-8cad-df9974bc0798_d46e3ffe-5815-4167-8c7c-b6f91f8a8342.html,,,,,, 4-methoxybenzyl alcohol,105-13-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/326bc2a2-b6de-4e86-b729-835757810153/documents/bad48868-d22e-490e-8cad-df9974bc0798_d46e3ffe-5815-4167-8c7c-b6f91f8a8342.html,,oral,LD50,"1,200 mg/kg bw",adverse effect observed, 4-methoxybenzyl alcohol,105-13-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/326bc2a2-b6de-4e86-b729-835757810153/documents/bad48868-d22e-490e-8cad-df9974bc0798_d46e3ffe-5815-4167-8c7c-b6f91f8a8342.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, Anisole,100-66-3,"The inhalation toxicity of anisole was studied in a sub-acute (29-day) inhalation toxicity study in Wistar rats according to the OECD guideline N°412 and in compliance with GLP ( Muijser 2012). Based on the experimental conditions of this study: - The NOAEC male and female rats was 3 g/m3 based on the absence of toxicologically relevant systemic effects. Only minor changes were observed in hematological and biochemical parameters at 3 g/m3. However these observations showed no dose- relation effects and there was no correlation between observations in males and females. Moreover, most changes were reversible after 18 days of recovery and were not accompanied by histopathological changes. No specific target organ toxicity was observed. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f47f399-b748-40e5-ba54-32bd66098c86/documents/IUC5-4e3ca1ae-876d-4650-8c6f-402217ea064a_7462af12-c0b7-452d-9aa4-b4faf76d45ec.html,,,,,, Anisole,100-66-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f47f399-b748-40e5-ba54-32bd66098c86/documents/IUC5-4e3ca1ae-876d-4650-8c6f-402217ea064a_7462af12-c0b7-452d-9aa4-b4faf76d45ec.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"3,000 mg/m3",,rat Anisole,100-66-3,Anisole is not harmful by any of the three routes of exposure: - Oral LD50 in male and female rats was 3700 mg/kg bw (95% confidence limits: 3240-4220 mg/kg bw).- Oral LD50 of Anisole to male white mice by gavage was 2800 mg/kg bw.- Dermal LD50/rabbits > 5000 mg/kg bw- Inhalation LC50 Male and Female rats/4 hours/ vapours: >6.51 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f47f399-b748-40e5-ba54-32bd66098c86/documents/IUC5-286a9e9f-7c6f-47a9-8f9a-e10e74a78bba_7462af12-c0b7-452d-9aa4-b4faf76d45ec.html,,,,,, "Anthemis nobilis, ext.",8015-92-7," The acute oral and dermal toxicity of Anthemis nobilis, ext. (Chamomile oil), was evaluated using 10 rats and 4 rabbits, respectively (strains and sex unspecified). The animals were administered a single dose of 5 g/kg bw, and were then observed for 14 days. There were no mortalities. The acute oral and dermal LD50 was reported to be > 5 g/kg bw (Johnson et al., 2017). No relevant acute inhalation toxicity data were identified, or are needed. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5981384e-a171-4734-bd6b-6aeefa17da19/documents/6143ae1a-b3ac-422b-b1e5-b0e9a213addd_dd83523e-a4d8-40e4-9609-8f0c0f2c502a.html,,,,,, Anthraquinone,84-65-1, One 90 days study of repeated dose toxicity by oral route was performed in 2018. The LOAEL of 50 mg/kg bw/day was established. There are two other studies of repeated dose toxicity by oral route for Anthraquinone available (as study summary) with these results: NOAEL: 2 mg/kg bw/day (28-day study) NOAEL: 1.36 mg/kg bw/day (90-day study) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bbc971e-10d1-4105-a59c-aabe8987686d/documents/IUC5-f2becd76-599f-4706-ba33-88654aea50fa_6409f5c3-b840-4c13-b10b-6dd056b7f71d.html,,,,,, Anthraquinone,84-65-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bbc971e-10d1-4105-a59c-aabe8987686d/documents/IUC5-f2becd76-599f-4706-ba33-88654aea50fa_6409f5c3-b840-4c13-b10b-6dd056b7f71d.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,50 mg/kg bw/day,,rat Anthraquinone,84-65-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bbc971e-10d1-4105-a59c-aabe8987686d/documents/IUC5-f2becd76-599f-4706-ba33-88654aea50fa_6409f5c3-b840-4c13-b10b-6dd056b7f71d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,5.2 mg/m3,, Anthraquinone,84-65-1,Acute toxicity:Oral: LD50: >2000 mg/kg bw for rat (limit test)Inhalation: LC50 >0.244 mg/l for ratDermal: LD50: >3000 mg/kg bw for rabbit ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bbc971e-10d1-4105-a59c-aabe8987686d/documents/IUC5-7db5700b-ccc0-491f-9888-2791353dd71d_6409f5c3-b840-4c13-b10b-6dd056b7f71d.html,,,,,, Anthraquinone,84-65-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bbc971e-10d1-4105-a59c-aabe8987686d/documents/IUC5-7db5700b-ccc0-491f-9888-2791353dd71d_6409f5c3-b840-4c13-b10b-6dd056b7f71d.html,,oral,LD50,"2,000 mg/kg bw",, Anthraquinone,84-65-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bbc971e-10d1-4105-a59c-aabe8987686d/documents/IUC5-7db5700b-ccc0-491f-9888-2791353dd71d_6409f5c3-b840-4c13-b10b-6dd056b7f71d.html,,dermal,LD50,"3,000 mg/kg bw",, Anthraquinone,84-65-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bbc971e-10d1-4105-a59c-aabe8987686d/documents/IUC5-7db5700b-ccc0-491f-9888-2791353dd71d_6409f5c3-b840-4c13-b10b-6dd056b7f71d.html,,inhalation,LC50,244 mg/m3,, Icosanoic acid,506-30-9,"The substance Eicosanoic acid does not exhibit repeated dose toxicity by the oral,inhalation and dermal route. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/4819ba77-3fab-448e-afc6-d8df6c6f4827/documents/IUC5-1bc6a687-186e-4f96-9f86-61514421e173_d4d9eb16-fbda-42e1-b8d7-2acc2b41cd04.html,,,,,, Icosanoic acid,506-30-9,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/4819ba77-3fab-448e-afc6-d8df6c6f4827/documents/IUC5-1bc6a687-186e-4f96-9f86-61514421e173_d4d9eb16-fbda-42e1-b8d7-2acc2b41cd04.html,Short-term repeated dose toxicity – systemic effects,oral,,"1,500 mg/kg bw/day",,rat Icosanoic acid,506-30-9,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/4819ba77-3fab-448e-afc6-d8df6c6f4827/documents/IUC5-1bc6a687-186e-4f96-9f86-61514421e173_d4d9eb16-fbda-42e1-b8d7-2acc2b41cd04.html,Short-term repeated dose toxicity – systemic effects,inhalation,,238.2 ,,rat Icosanoic acid,506-30-9,"The substance Eicosanoic acid is not expected to show acute toxicity effect by the oral, inhalation and dermal route. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4819ba77-3fab-448e-afc6-d8df6c6f4827/documents/IUC5-9cf6cd45-ac21-4367-aa93-8aacf6d56b8c_d4d9eb16-fbda-42e1-b8d7-2acc2b41cd04.html,,,,,, Icosanoic acid,506-30-9,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4819ba77-3fab-448e-afc6-d8df6c6f4827/documents/IUC5-9cf6cd45-ac21-4367-aa93-8aacf6d56b8c_d4d9eb16-fbda-42e1-b8d7-2acc2b41cd04.html,,oral,LD50,"8,250 mg/kg bw",no adverse effect observed, Icosanoic acid,506-30-9,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4819ba77-3fab-448e-afc6-d8df6c6f4827/documents/IUC5-9cf6cd45-ac21-4367-aa93-8aacf6d56b8c_d4d9eb16-fbda-42e1-b8d7-2acc2b41cd04.html,,dermal,LD50,"3,575.76 mg/kg bw",no adverse effect observed, Icosan-1-ol,629-96-9,"A reliable 90-days dietary study in rats, using hexadecan-1-ol and reporting a NOAEL value greater than 4415 mg/kg bw/day based on no observed adverse effects is read-across (Scientific Assoc, 1966a; rel. 2) There is also a reliable 26-week oral gavage study available on an analogue substance docosan-1-ol that reported no adverse effects at the highest dose tested, 1000 mg/kg bw/day (Iglesias et al., 2002a).   Both studies are used as weight of evidence but as no adverse systemic effects were observed for category members, the study using the highest dose from the available data was considered as the basis for classification. Therefore, the 90-day dietary study conducted with the structurally analogous substance hexadecan-1-ol is used to derive the NOAEL for icosan-1-ol.   A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test has been commissioned with the analogue substance docosan-1-ol and is conducted according to OECD Test Guideline 422 and in compliance with GLP. Results will be reported once the final report is available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c1ee875-ec1b-45b5-b2dd-15d7df2b09a9/documents/172f584c-2bef-4d11-bb91-3fead1b2afec_03790890-3741-42c6-aacc-15f76a5ce2b6.html,,,,,, Icosan-1-ol,629-96-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c1ee875-ec1b-45b5-b2dd-15d7df2b09a9/documents/172f584c-2bef-4d11-bb91-3fead1b2afec_03790890-3741-42c6-aacc-15f76a5ce2b6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"4,415 mg/kg bw/day",,rat Icosan-1-ol,629-96-9,"The key acute oral toxicity study is read-across from the structurally analogous substance docosan-1-ol (CAS 661-19-8, EC 221-546-6). The study was conducted according to OECD Test Guideline 401 and in compliance with GLP, and reports an LD50 value of > 2000 mg/kg in rat (Safepharm Laboratories, 1997; rel 1).   The key acute dermal toxicity study for icosan-1-ol (CAS 629-96-9, EC 211-119-4), conducted according to generally acceptable scientific principles and prior to GLP, reports an LD50 value of > 16800 mg/kg (Smyth 1969; rel 2).    No testing is required via inhalatory route since high reliability studies are already in place via the oral and dermal route. Furthermore, the LC50 for inhalation is expected to be greater than the substantially saturated vapour concentration based on weight of evidence across category. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c1ee875-ec1b-45b5-b2dd-15d7df2b09a9/documents/66ae86fb-3cb5-46f2-8cac-bcefae2334be_03790890-3741-42c6-aacc-15f76a5ce2b6.html,,,,,, Icosan-1-ol,629-96-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c1ee875-ec1b-45b5-b2dd-15d7df2b09a9/documents/66ae86fb-3cb5-46f2-8cac-bcefae2334be_03790890-3741-42c6-aacc-15f76a5ce2b6.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Icosan-1-ol,629-96-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c1ee875-ec1b-45b5-b2dd-15d7df2b09a9/documents/66ae86fb-3cb5-46f2-8cac-bcefae2334be_03790890-3741-42c6-aacc-15f76a5ce2b6.html,,dermal,LD50,"> 16,800 mg/kg bw",no adverse effect observed, Arginine,74-79-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP guideline study with Klimisch Code 1. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01441d6a-4d69-4e9a-b859-d9a4c2828d64/documents/IUC5-e75e8e07-662a-40e0-bef3-7841c882c952_b1a3ec4b-5bf5-4c6a-8ea1-7f89a394eb42.html,,,,,, Arginine,74-79-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01441d6a-4d69-4e9a-b859-d9a4c2828d64/documents/IUC5-e75e8e07-662a-40e0-bef3-7841c882c952_b1a3ec4b-5bf5-4c6a-8ea1-7f89a394eb42.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,130.9 mg/kg bw/day",,rat Arginine,74-79-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch code 2: Comparable to guideline study with acceptable restrictions ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01441d6a-4d69-4e9a-b859-d9a4c2828d64/documents/IUC5-0ac0c0ac-425b-4a6f-8f71-2ef217058623_b1a3ec4b-5bf5-4c6a-8ea1-7f89a394eb42.html,,,,,, Arginine,74-79-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01441d6a-4d69-4e9a-b859-d9a4c2828d64/documents/IUC5-0ac0c0ac-425b-4a6f-8f71-2ef217058623_b1a3ec4b-5bf5-4c6a-8ea1-7f89a394eb42.html,,oral,LD50,"5,110 mg/kg bw",no adverse effect observed, (+)-L-arginine hydrochloride,1119-34-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch code 1: GLP guideline study ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c96b0445-bab5-4f2f-9353-98338f8e9451/documents/IUC5-b7dcc2fb-048d-447c-b549-ace5319087a5_93a69043-fc35-4983-83ae-66a6612bfe47.html,,,,,, (+)-L-arginine hydrochloride,1119-34-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch code 2: Study well documented, meets generally accepted scientific principles, acceptable for assessment. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c96b0445-bab5-4f2f-9353-98338f8e9451/documents/IUC5-adc6e1dd-fb1f-4b64-9ea9-d452639911a4_93a69043-fc35-4983-83ae-66a6612bfe47.html,,,,,, (+)-L-arginine hydrochloride,1119-34-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c96b0445-bab5-4f2f-9353-98338f8e9451/documents/IUC5-adc6e1dd-fb1f-4b64-9ea9-d452639911a4_93a69043-fc35-4983-83ae-66a6612bfe47.html,,oral,LD50,"12,400 mg/kg bw",no adverse effect observed, "Artemisia herba-alba, ext.",84775-75-7, Based on CLP regulation an ATE for oral toxicity was calculated at 223.6 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9aa0da7-4055-4750-9c3e-2d6b17fedacd/documents/74d59d69-c91b-4779-875a-27b7b93e4406_44a4a118-6d29-49da-8d7d-1adb008b3875.html,,,,,, "Artemisia herba-alba, ext.",84775-75-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9aa0da7-4055-4750-9c3e-2d6b17fedacd/documents/74d59d69-c91b-4779-875a-27b7b93e4406_44a4a118-6d29-49da-8d7d-1adb008b3875.html,,oral,discriminating dose,194 mg/kg bw,adverse effect observed, "Artemisia pallens, ext.",91844-86-9,"Acute toxicity oral, rat (MB research, 1976, OECD Guideline 401): LD50 > 5 mg/kg body weight. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The oral LD50 value of Davana oil is determined to be greater than 5 g/kg body weight. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11ccdeec-4300-400b-9083-0c45045e9c03/documents/cb5e0038-2774-4eab-b1ae-28d43f96a120_d5ebed57-c101-4bbc-a669-eb8e52d0cbc9.html,,,,,, "Artemisia pallens, ext.",91844-86-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11ccdeec-4300-400b-9083-0c45045e9c03/documents/cb5e0038-2774-4eab-b1ae-28d43f96a120_d5ebed57-c101-4bbc-a669-eb8e52d0cbc9.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "Ascophyllum nodosum, ext.",84775-78-0,"OECD TG 408, GLP, 100, 300, 1000 mg/kg bw/day, rat, Results: NOAEL = 1000 mg/kg bw/day.  ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/27021bfb-970b-4bc1-bb7e-14812a76c9db/documents/IUC5-8cdd4851-4ee9-4979-bc1f-4570731551e2_e17bc104-77d0-4d59-bb7b-e2c4a7ffdfc3.html,,,,,, "Ascophyllum nodosum, ext.",84775-78-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/27021bfb-970b-4bc1-bb7e-14812a76c9db/documents/IUC5-8cdd4851-4ee9-4979-bc1f-4570731551e2_e17bc104-77d0-4d59-bb7b-e2c4a7ffdfc3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Ascophyllum nodosum, ext.",84775-78-0,"oral OPPTS 870.1100 (2002), GLP, rat (female), oral, 14-day observation period, LD50 > 5000 mg/kg bw   inhalation OPPTS 870.1300 (1998), GLP, rat (male/female), inhalation, 4 h, 14-day observation period, LC50 > 5.48 mg/L   dermal OPPTS 870.1200 (1998), GLP, rat (male/female), dermal, 14-day observation period, LD50 > 5000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27021bfb-970b-4bc1-bb7e-14812a76c9db/documents/IUC5-8da76d24-528b-424a-9c31-2ffb2297bda1_e17bc104-77d0-4d59-bb7b-e2c4a7ffdfc3.html,,,,,, "Ascophyllum nodosum, ext.",84775-78-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27021bfb-970b-4bc1-bb7e-14812a76c9db/documents/IUC5-8da76d24-528b-424a-9c31-2ffb2297bda1_e17bc104-77d0-4d59-bb7b-e2c4a7ffdfc3.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "Ascophyllum nodosum, ext.",84775-78-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27021bfb-970b-4bc1-bb7e-14812a76c9db/documents/IUC5-8da76d24-528b-424a-9c31-2ffb2297bda1_e17bc104-77d0-4d59-bb7b-e2c4a7ffdfc3.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "Ascophyllum nodosum, ext.",84775-78-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27021bfb-970b-4bc1-bb7e-14812a76c9db/documents/IUC5-8da76d24-528b-424a-9c31-2ffb2297bda1_e17bc104-77d0-4d59-bb7b-e2c4a7ffdfc3.html,,inhalation,LC50,5.48 mg/L,no adverse effect observed, "O-6-deoxy-α-L-mannopyranosyl-(1→4)-O-β-D-glucopyranosyl-(1→6)-β-D-glucopyranosyl (2α,3β,4α)-2,3,23-trihydroxyurs-12-en-28-oate",16830-15-2,"The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat.According to the criteria for classification, packaging and labelling of dangerous substances in accordance with the E.E.C. Directives 67/548 and 99/45, the test item must not be classified. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14cc792c-bb41-48ad-a9dc-c353572ea1cf/documents/b17ae8fd-946a-4f63-98e8-7a5f5158b666_e45d0b53-8f2c-41a7-95e9-2266ff298908.html,,,,,, "O-6-deoxy-α-L-mannopyranosyl-(1→4)-O-β-D-glucopyranosyl-(1→6)-β-D-glucopyranosyl (2α,3β,4α)-2,3,23-trihydroxyurs-12-en-28-oate",16830-15-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14cc792c-bb41-48ad-a9dc-c353572ea1cf/documents/b17ae8fd-946a-4f63-98e8-7a5f5158b666_e45d0b53-8f2c-41a7-95e9-2266ff298908.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Asparagine,70-47-3," - subchronic (90 d study) repeated dose toxicity study oral (diet), rat Fischer 344/DuCrj m/f (OECD TG 408), dose levels: 1.25%, 2.5%, and 5% , corresponding to 857, 1708 and 3466 mg/kg bw/day (females) and 753, 1537 and 3242 mg/kg bw/day(males); NOAEL = 1730 mg/kg bw/day (females) and 1650 mg/kg bw/day (males). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bbf970f2-624f-47c1-9a43-295a3e94bbc3/documents/b063e388-36b1-47a4-9d9b-1ba4d60dd829_2466923a-a28f-4435-bb84-10baddc0e5f6.html,,,,,, Asparagine,70-47-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bbf970f2-624f-47c1-9a43-295a3e94bbc3/documents/b063e388-36b1-47a4-9d9b-1ba4d60dd829_2466923a-a28f-4435-bb84-10baddc0e5f6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,650 mg/kg bw/day",,rat Asparagine,70-47-3," Acute oral toxicity: LD50 > 16000 mg/kg bw, in female and male CFY rats, comparable to OECD Test Guideline 401, non-GLP study Acute inhalation toxicity: No study available, particle size, partition coefficient and water solubility of the test item indicate that although its solubility is high and the partition coefficient is low, the mean median diameter is above the threshold for inhalation, thus, exposure via inhalation is not expected. Due to the low vapour pressure the exposure to aerosols is also not expected. Acute toxicity: dermal: No study available, partition coefficient, water solubility and molecular weight indicate that the test item although small enough is considered to be highly hydrophilic and dermal penetration is considered to be very low. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbf970f2-624f-47c1-9a43-295a3e94bbc3/documents/5af23080-ff04-4f90-a838-f790425db27f_2466923a-a28f-4435-bb84-10baddc0e5f6.html,,,,,, Asparagine,70-47-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbf970f2-624f-47c1-9a43-295a3e94bbc3/documents/5af23080-ff04-4f90-a838-f790425db27f_2466923a-a28f-4435-bb84-10baddc0e5f6.html,,oral,LD50,"16,000 mg/kg bw",no adverse effect observed, Aspartic acid,56-84-8,"In 2 subchronic feeding studies with rats, NOAELs of 700 respectively 500 mg/kg bw/day were found. The NOEL of 700 mg/kg bw/day is preferred, as in this study by Tada 2008, 4 doses were investigated, wheras the 500 mg/kg bw/day of the Karaman 2011 study originate from a single dose experiment and are therefore less adequate.It can be anticipated that no different toxic effects will be produced by the other routes because L-aspartic acid will be metabolised in each cell where it enters the Krebs cycle and the urea cycle and is rapidly metabolised to CO2. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6aa8f048-062c-4e52-a7ec-3f72eaea13e7/documents/IUC5-e0c40d97-4605-4e85-b109-48a829644775_4b8f2ae0-b6a3-4669-bb01-dab3a1dc21b3.html,,,,,, Aspartic acid,56-84-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6aa8f048-062c-4e52-a7ec-3f72eaea13e7/documents/IUC5-e0c40d97-4605-4e85-b109-48a829644775_4b8f2ae0-b6a3-4669-bb01-dab3a1dc21b3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,700 mg/kg bw/day,,rat Aspartic acid,56-84-8,L-aspartic acid is a naturally occurring amino acid and is practically non-toxic in the acute toxicity studies available. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6aa8f048-062c-4e52-a7ec-3f72eaea13e7/documents/IUC5-77ea3e3b-9388-436c-87d6-8d08b42b89f8_4b8f2ae0-b6a3-4669-bb01-dab3a1dc21b3.html,,,,,, Aspartic acid,56-84-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6aa8f048-062c-4e52-a7ec-3f72eaea13e7/documents/IUC5-77ea3e3b-9388-436c-87d6-8d08b42b89f8_4b8f2ae0-b6a3-4669-bb01-dab3a1dc21b3.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Aspartic acid,56-84-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6aa8f048-062c-4e52-a7ec-3f72eaea13e7/documents/IUC5-77ea3e3b-9388-436c-87d6-8d08b42b89f8_4b8f2ae0-b6a3-4669-bb01-dab3a1dc21b3.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Aziridine,151-56-4,"In an oral repeated dose study with rabbits an NOAEL could not be derived. The effect seen in surviving animals was renal papillary necrosis. Effects seen in animals that died during the study were apathy, atony, and proteinuria.In a 10 day dermal repeated dose study with rabbits a NOAEL could not be identified. Effects seen in surviving animals were skin edema and red-brown, widespread parchment-like necrosis with confluent blood discharge.Regarding inhalation exposure, Sprague-Dawley rats that were exposed 5 hours/day, 5 days/week for 27 weeks or until death a NOAEC could not be identified. Exposure to the test substance caused reduced lifespan of the rats, histopathological changes in kidney and trachea and an increased incidence of tumours in trachea, lung, skin and breast. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e10af955-f84e-46bb-a7d5-86b11884861e/documents/IUC5-4ec02f9e-0505-4232-9cbe-24dd594fe9e2_cd77cf57-5493-417b-b640-99849661007d.html,,,,,, Aziridine,151-56-4,"The acute oral and acute dermal toxicity was investigated in studies performed comparable to the relevant guidelines (OECD420 and Hill, Ass. Food and Drug Off. 18, 1954), resulting in an LD50 of 4.9 mg/kg bw, and 12.45 mg/kg bw, respectively (BASF AG, 1967; BASF AG, 1965). The acute inhalation toxicity was investigated in a study according to internal BASF guidelines, an LC50 was not determined in this study (BASF AG, 1966). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e10af955-f84e-46bb-a7d5-86b11884861e/documents/IUC5-7ce6918f-0d5f-4fc3-9058-bf90b02166b5_cd77cf57-5493-417b-b640-99849661007d.html,,,,,, Aziridine,151-56-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e10af955-f84e-46bb-a7d5-86b11884861e/documents/IUC5-7ce6918f-0d5f-4fc3-9058-bf90b02166b5_cd77cf57-5493-417b-b640-99849661007d.html,,oral,LD50,4.9 mg/kg bw,, Aziridine,151-56-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e10af955-f84e-46bb-a7d5-86b11884861e/documents/IUC5-7ce6918f-0d5f-4fc3-9058-bf90b02166b5_cd77cf57-5493-417b-b640-99849661007d.html,,dermal,LD50,12.45 mg/kg bw,, Barium chloride,10361-37-2,Reliable studies via the oral route are available for barium dichloride. The main adverse effect caused by barium dichloride was the nephrotoxicity in rats and mice of both sexes. No information via the dermal and inhalation route is available for barium dichloride and other soluble barium substances. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/627558c4-4e5d-40ac-821a-7717a83920ec/documents/346f04bf-229f-472d-9cbf-e6e0e72361f7_122c2999-97dd-4cb3-84a7-296b2568840c.html,,,,,, Barium chloride,10361-37-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/627558c4-4e5d-40ac-821a-7717a83920ec/documents/346f04bf-229f-472d-9cbf-e6e0e72361f7_122c2999-97dd-4cb3-84a7-296b2568840c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,139 mg/kg bw/day,,rat Barium chloride,10361-37-2,Acute oral toxicity: LD50 ≥ 100 till ≤ 300 mg/kg bw.Acute dermal toxicity: derogation statement included; according to SIAR 2008 an LD50 > 2000 mg/kg was stated in the NIAR report 2008Acute inhalation toxicity: LC50 > 1 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/627558c4-4e5d-40ac-821a-7717a83920ec/documents/3bd2d506-b850-40df-acbc-c9e382e2e234_122c2999-97dd-4cb3-84a7-296b2568840c.html,,,,,, Barium dodecairon nonadecaoxide,12047-11-9,Inhaled barium hexaferrite powder may induce pneumoconiosis (identified as critical effect) following repeated exposure at concentrations higher than 30 mg/m3 (NOAEC). ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b125c2b1-216c-4653-99d2-525adc2e24df/documents/IUC5-775e2564-eebe-4646-a7fc-4120970df46e_30af1418-14a5-4e14-9f5f-fb4b7fa3beba.html,,,,,, Barium dodecairon nonadecaoxide,12047-11-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b125c2b1-216c-4653-99d2-525adc2e24df/documents/IUC5-775e2564-eebe-4646-a7fc-4120970df46e_30af1418-14a5-4e14-9f5f-fb4b7fa3beba.html,Chronic toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat Barium dodecairon nonadecaoxide,12047-11-9,Acute oral toxicity: the estimated DL50 value is higher than 2000 mg/kg bw.Acute inhalation toxicity: no DL50 value may be estimated. The substance can cause adverse effects to the lungs. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b125c2b1-216c-4653-99d2-525adc2e24df/documents/IUC5-02e1501f-1449-4810-bec6-c34d1c2f7379_30af1418-14a5-4e14-9f5f-fb4b7fa3beba.html,,,,,, Barium dodecairon nonadecaoxide,12047-11-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b125c2b1-216c-4653-99d2-525adc2e24df/documents/IUC5-02e1501f-1449-4810-bec6-c34d1c2f7379_30af1418-14a5-4e14-9f5f-fb4b7fa3beba.html,,oral,LD50,"2,001 mg/kg bw",, Barium sulfate,7727-43-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48b71d0b-0977-46dc-aa2a-666a6ffda615/documents/IUC5-a696934f-06b8-4d45-aa61-489b55af89c7_95d75e2b-a9dc-41a4-b517-171503150ffd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,104 mg/kg bw/day,,rat Barium sulfate,7727-43-7,"Acute toxicity, oral: LD50 >5000 mg/kg bw Acute toxicity, dermal: waiving (LD50 >2000 mg/kg bw (only secondary information))Acute toxicity, inhalation: waiving ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48b71d0b-0977-46dc-aa2a-666a6ffda615/documents/IUC5-2c46936c-3843-48ea-80cb-27fea4e58551_95d75e2b-a9dc-41a4-b517-171503150ffd.html,,,,,, Barium sulphide,21109-95-5,"According to the data requirements as outlined in section 8.6, column 2, Annexes VIII-IX, of Regulation (EC) 1907/2006 a repeated dose toxicity study shall be performed via the most appropriate route of administration, having regard to the likely route of human exposure. However, in case of barium sulfide the inhalation route AND the oral route are considered as the relevant routes of exposures. Adequate repeated dose toxicity studies are available for inhalation of hydrogen sulfide and oral intake of barium chloride dihydrate (see discussion). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04029319-e282-43eb-a0de-18fcaae81db3/documents/IUC5-44ee8115-4eda-4aa6-9ed4-60a6eb30d826_52ab5196-a13d-4448-9754-7f34c25fbad7.html,,,,,, Barium sulphide,21109-95-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04029319-e282-43eb-a0de-18fcaae81db3/documents/IUC5-44ee8115-4eda-4aa6-9ed4-60a6eb30d826_52ab5196-a13d-4448-9754-7f34c25fbad7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,75.5 mg/kg bw/day,,rat Barium sulphide,21109-95-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04029319-e282-43eb-a0de-18fcaae81db3/documents/IUC5-44ee8115-4eda-4aa6-9ed4-60a6eb30d826_52ab5196-a13d-4448-9754-7f34c25fbad7.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,552 mg/m3,,rat Barium sulphide,21109-95-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04029319-e282-43eb-a0de-18fcaae81db3/documents/IUC5-44ee8115-4eda-4aa6-9ed4-60a6eb30d826_52ab5196-a13d-4448-9754-7f34c25fbad7.html,Repeated dose toxicity – local effects,inhalation,NOAEC,69.5 mg/m3,adverse effect observed,rat Barium sulphide,21109-95-5,One study is available for acute oral toxicity (k_Müller_1983_BaS) conducted with barium sulfide in accordance with OECD 401. An LD50 of 307 mg/kg bw has been calculated for males/females. The LD50 for males is 336 mg/kg bw and for females an LD50 of 275 mg/kg bw. has been calculated (see attachment in the IUCLID robust study summary 7.2.1). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04029319-e282-43eb-a0de-18fcaae81db3/documents/IUC5-c4fb7902-771d-449e-a7cc-4157da50a888_52ab5196-a13d-4448-9754-7f34c25fbad7.html,,,,,, Barium sulphide,21109-95-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04029319-e282-43eb-a0de-18fcaae81db3/documents/IUC5-c4fb7902-771d-449e-a7cc-4157da50a888_52ab5196-a13d-4448-9754-7f34c25fbad7.html,,oral,LD50,214 mg/kg bw,adverse effect observed, "[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride",2580-56-5, Acute oral toxicity in rats: LD50 between 300 and 2000 mg/kg. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c124739d-4310-41d4-912f-d62fcb9be9e0/documents/fba55cba-e25f-4550-8af0-fac8b6fbfd76_45a0f29a-bc0d-4ef0-80d1-a3897f68c6c8.html,,,,,, "[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride",2580-56-5,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c124739d-4310-41d4-912f-d62fcb9be9e0/documents/fba55cba-e25f-4550-8af0-fac8b6fbfd76_45a0f29a-bc0d-4ef0-80d1-a3897f68c6c8.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium methyl sulphate,12270-13-2," No data is available for the target substance. Thus, available data from the structural analogue (chloride salt) of the target substance was used in a read-across approach. Details on the read-across rational are provided in section 13. The source substance was tested in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422). Based on the occurrence of the histopathological findings observed in the heart of all dose levels, the NOAEL for general toxicity could not be determined. Thus, the LOAEL for systemic effects can be considered to be 40 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8957f974-3817-4593-aefe-6a0440b58ff5/documents/5846348d-7547-44f3-b57f-22f0620f38ec_c6c041bf-9d18-40d2-b2c4-454ca94c2c6f.html,,,,,, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium methyl sulphate,12270-13-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8957f974-3817-4593-aefe-6a0440b58ff5/documents/5846348d-7547-44f3-b57f-22f0620f38ec_c6c041bf-9d18-40d2-b2c4-454ca94c2c6f.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,40 mg/kg bw/day,,rat 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium methyl sulphate,12270-13-2," In an acute oral toxicity study (Grundler, 1981) conducted with the target substance (18.3%) in a mixture, the combined oral LD50 was determined to be 3.680 mg/kg bw. By extrapolating the concentration of 18.3% of the target substance within the mixture to 100% the calculated combined LD50 value would be 675 mg/kg bw. In a second acute oral toxicity study (Hackenberg, 1977) conducted with the target substance (20%) in a mixture, the combined oral LD50 was determined to 2.060 mg/kg bw. By extrapolating the concentration of 20% of the target substance within the mixture to 100% the calculated LD50 value would be 412 mg/kg bw for both sexes. Supporting information is provided by the study by Katz, 1970 in a read-across approach to get information on the toxicity of the chromophore itself. In this study, the acute oral LD50 in rats was determined to be 3.700 mg/kg bw in males and 4.300 mg/kg bw in females. Details on the read-across rational are provided in section 13. No data regarding the target substance was available for acute toxicity via the inhalation route. Furthermore, as the substance is only marketed as an aqueous solution containing significant concentrations of free acetic acid as stabiliser, this route of exposure is not relevant and animal testing is not considered to be in accordance with animal welfare regulations. Thus, available data from the chloride salt of the target substance was used in a read-across approach solely to get information on the toxicity of the chromophore itself. Based on the results obtained from an in vivo acute inhalation study, the combined LC0 value of the source substance can be considered to be 1.0408 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8957f974-3817-4593-aefe-6a0440b58ff5/documents/66e3059d-8538-4625-a305-bd1b8b0ce4ca_c6c041bf-9d18-40d2-b2c4-454ca94c2c6f.html,,,,,, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium methyl sulphate,12270-13-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8957f974-3817-4593-aefe-6a0440b58ff5/documents/66e3059d-8538-4625-a305-bd1b8b0ce4ca_c6c041bf-9d18-40d2-b2c4-454ca94c2c6f.html,,oral,LD50,412 mg/kg bw,adverse effect observed, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium methyl sulphate,12270-13-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8957f974-3817-4593-aefe-6a0440b58ff5/documents/66e3059d-8538-4625-a305-bd1b8b0ce4ca_c6c041bf-9d18-40d2-b2c4-454ca94c2c6f.html,,inhalation,LC50,"1,040.8 mg/m3",no adverse effect observed, "3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride",68123-13-7,LD50 for the test chemical Basic Blue 99 is found to be between 2700 mg/kg. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eadcca7d-b29b-4787-b207-d1841d12e081/documents/IUC5-97b38be7-d0e3-4c58-8f5b-b36014d5af60_34d8a4f7-2823-4ff4-91e4-3e18144d9460.html,,,,,, "3-[(4-amino-6-bromo-5,8-dihydro-1-hydroxy-8-imino-5-oxo-2-naphtyl)amino]-N,N,N-trimethylanilinium chloride",68123-13-7,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eadcca7d-b29b-4787-b207-d1841d12e081/documents/IUC5-97b38be7-d0e3-4c58-8f5b-b36014d5af60_34d8a4f7-2823-4ff4-91e4-3e18144d9460.html,,oral,LD50,"2,700 mg/kg bw",no adverse effect observed, [8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride,26381-41-9,"LD50 was considered to be between 2000 and 4000 mg/kg bw when CYF male and female rats were treated with Basic Brown 16. Therefore, Basic Brown 16 cannot be classified as per the criteria of CLP regulation for acute oral toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea1261a1-4fef-4e77-b3c5-b5b508444deb/documents/IUC5-da57eb62-a2a7-4260-bec8-8db1509e8e35_a96237b1-414a-4938-af6e-de3f94c264c1.html,,,,,, [8-[(p-aminophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride,26381-41-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea1261a1-4fef-4e77-b3c5-b5b508444deb/documents/IUC5-da57eb62-a2a7-4260-bec8-8db1509e8e35_a96237b1-414a-4938-af6e-de3f94c264c1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, [8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride,68391-32-2," Acute oral toxicity: The study was designed and conducted to determine the acute oral toxicity profile of [8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-2-naphthyl] trimethylammonium chloride in Sprague Dawley rats. Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. As no mortality were observed at 24 hours after the dosing, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups. It was concluded that the acute oral median lethal dose (LD50) of [8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride supplied by Sustainability Support Services (Europe) AB, Sweden, when administered to Sprague Dawley rats was found to be 2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that [8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-2-naphthyl]trimethyl ammonium chloride falls into the “Category 4” which is relatively nontoxic. Acute Dermal toxicity: The study was designed and conducted to determine the acute dermal toxicity profile of [8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-2-naphthyl] trimethylammonium chloride in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days.Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. It was concluded that the acute dermal median lethal dose (LD50) of [8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-2-naphthyl] trimethylammonium chloride supplied bySustainability Support Services (Europe) AB, Sweden, when administered to male and female Sprague Dawley rats was found to be greater than 2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that [8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy -2-naphthyl] trimethylamm onium chloride does not exhibits acute toxicity by the dermal route. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ad8f8a6-4396-431b-8e8c-c6dccfb6eb25/documents/IUC5-50c37465-a2a9-40dc-8e4f-cac5423b554c_4e69ad9d-c02c-457b-a9ea-008dece6b485.html,,,,,, [8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride,68391-32-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ad8f8a6-4396-431b-8e8c-c6dccfb6eb25/documents/IUC5-50c37465-a2a9-40dc-8e4f-cac5423b554c_4e69ad9d-c02c-457b-a9ea-008dece6b485.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, [8-[(4-amino-3-nitrophenyl)azo]-7-hydroxy-2-naphthyl]trimethylammonium chloride,68391-32-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ad8f8a6-4396-431b-8e8c-c6dccfb6eb25/documents/IUC5-50c37465-a2a9-40dc-8e4f-cac5423b554c_4e69ad9d-c02c-457b-a9ea-008dece6b485.html,,dermal,LD50,"2,000 mg/kg bw",, "[4-[4-(diethylamino)benzhydrylene]cyclohexa-2,5-dien-1-ylidene]diethylammonium hydrogen sulphate",633-03-4,"OECD 423, ks, LD50 = ca 674 mg/Kg bw OECD 423, ss, LD50 = ca 786 mg/Kg bw 1983, ss, LD50 of 520 mg/Kg bw 1994, ss, LD50 for Wistar rat = 275 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b0d94c4-bfb5-4c46-ad5a-91efb6441c89/documents/IUC5-f2364eee-5af7-4477-9701-75a53325f8d7_2e927b2b-d286-4954-a0d1-98a7770320de.html,,,,,, "[4-[4-(diethylamino)benzhydrylene]cyclohexa-2,5-dien-1-ylidene]diethylammonium hydrogen sulphate",633-03-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b0d94c4-bfb5-4c46-ad5a-91efb6441c89/documents/IUC5-f2364eee-5af7-4477-9701-75a53325f8d7_2e927b2b-d286-4954-a0d1-98a7770320de.html,,oral,LD50,674 mg/kg bw,adverse effect observed, "[4-[4-(diethylamino)benzhydrylene]cyclohexa-2,5-dien-1-ylidene]diethylammonium hydrogen sulphate",633-03-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b0d94c4-bfb5-4c46-ad5a-91efb6441c89/documents/IUC5-f2364eee-5af7-4477-9701-75a53325f8d7_2e927b2b-d286-4954-a0d1-98a7770320de.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthylium chloride",989-38-8, In an acute oral toxicity study an LD50 of 250 mg/kg was determined for the test item in rats. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb073295-72b4-4a98-bedb-e599959865b2/documents/8bcaa0e8-5486-4664-85bc-47f5fe640d68_6bba7085-343b-4e9f-b3b1-76c618688553.html,,,,,, "9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthylium chloride",989-38-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb073295-72b4-4a98-bedb-e599959865b2/documents/8bcaa0e8-5486-4664-85bc-47f5fe640d68_6bba7085-343b-4e9f-b3b1-76c618688553.html,,oral,LD50,250 mg/kg bw,adverse effect observed, "3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethylxanthylium chloride",3068-39-1," Oral (Subacute): Under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) of the test material is 1.5 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fad3227d-c023-4a62-a603-098984a6cbfb/documents/d63d9e79-5753-4178-ba10-590c76d1e49c_aa437e6a-f221-41b3-8d24-1cd97a709cbd.html,,,,,, "3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethylxanthylium chloride",3068-39-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fad3227d-c023-4a62-a603-098984a6cbfb/documents/d63d9e79-5753-4178-ba10-590c76d1e49c_aa437e6a-f221-41b3-8d24-1cd97a709cbd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat "3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethylxanthylium chloride",3068-39-1," Acute oral toxicity: Under the conditions of the study, the LD50 of the test material was found to be 449 mg/kg bw for males and females combined (95 % confidence limit 322 to 626 mg/kg bw). The LD50 for males was 410 mg/kg bw (95 % CL 265 to 636 mg/kg bw) and for females was 453 mg/kg bw (95 % CL 266 to 771 mg/kg bw). Acute inhalation toxicity: Under the conditions of this study, the 4 h LC50 value via the inhalation route was established to be within the range of 0.05 to 0.5 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fad3227d-c023-4a62-a603-098984a6cbfb/documents/bf6684d7-2db2-4b13-91d1-a05ae9be5677_aa437e6a-f221-41b3-8d24-1cd97a709cbd.html,,,,,, "3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethylxanthylium chloride",3068-39-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fad3227d-c023-4a62-a603-098984a6cbfb/documents/bf6684d7-2db2-4b13-91d1-a05ae9be5677_aa437e6a-f221-41b3-8d24-1cd97a709cbd.html,,oral,LD50,410 mg/kg bw,adverse effect observed, "3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethylxanthylium chloride",3068-39-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fad3227d-c023-4a62-a603-098984a6cbfb/documents/bf6684d7-2db2-4b13-91d1-a05ae9be5677_aa437e6a-f221-41b3-8d24-1cd97a709cbd.html,,inhalation,LC50,50 mg/m3,adverse effect observed, [7-hydroxy-8-[(2-methoxyphenyl)azo]-2-naphthyl]trimethylammonium chloride,68391-30-0,An acute oral study was carried on Wistar rats to determine the acute oral toxicity of Basic Red 76. Groups of 3 male and 3 female rats received a single oral dose of 2000 mg/kg bw.The LD50 was reported to be greater than 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71e9d8b8-b521-4a2e-98d5-06b851e76f7d/documents/IUC5-e7914f65-0fd9-415a-954c-249557559a4f_0e480bb1-f883-48f2-952f-4df3d81ce380.html,,,,,, [7-hydroxy-8-[(2-methoxyphenyl)azo]-2-naphthyl]trimethylammonium chloride,68391-30-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71e9d8b8-b521-4a2e-98d5-06b851e76f7d/documents/IUC5-e7914f65-0fd9-415a-954c-249557559a4f_0e480bb1-f883-48f2-952f-4df3d81ce380.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,6-bis(diethylamino)-9-[2-(methoxycarbonyl)phenyl]xanthylium tetrachlorozincate",73398-89-7," Acute oral toxicity:Under the conditions of the study, the oral LD50 value of the test material in Wistar rats was established to be within the range of 50 to 300 mg/kg body weight. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d73ee979-fcf5-4276-8747-d8096a4733a3/documents/0da24960-cf33-4877-977a-443a775417ae_71b6510d-740b-45cd-801d-df4f028d8fce.html,,,,,, "3,6-bis(diethylamino)-9-[2-(methoxycarbonyl)phenyl]xanthylium tetrachlorozincate",73398-89-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d73ee979-fcf5-4276-8747-d8096a4733a3/documents/0da24960-cf33-4877-977a-443a775417ae_71b6510d-740b-45cd-801d-df4f028d8fce.html,,oral,LD50,50 mg/kg bw,adverse effect observed, "(4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride",632-99-5," LD50 was estimated to be 2884 mg/kg bw when Wistar female rats were orally exposed with (4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3452868-b02c-48dc-8bcb-fd65a7ec0412/documents/4de04fda-ca4a-4338-a9cd-8c888fb94478_e8d751a6-70fd-4b01-ac62-a17b1322630c.html,,,,,, "(4-(4-aminophenyl)(4-iminocyclohexa-2,5-dienylidene)methyl)-2-methylaniline hydrochloride",632-99-5,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3452868-b02c-48dc-8bcb-fd65a7ec0412/documents/4de04fda-ca4a-4338-a9cd-8c888fb94478_e8d751a6-70fd-4b01-ac62-a17b1322630c.html,,oral,LD50,"2,884 mg/kg bw",no adverse effect observed, "4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride",3248-91-7," Repeated dose oral toxicity study was performed to determine the oral toxic nature of Basic Violet 2 upon repeated exposure for 13 weeks to rats (SCCS, 2011). The test chemical dissolved in water as vehicle at dose levels of 3, 10 or 30 mg/kg bw/day was administered by the gavage route to 10 male and 10 female Sprague Dawley Hsd: SD strain rats for 13 weeks. The animals were observed for mortality, clinical signs, ophthalmology, neurotoxicity, body weight and organ weight changes, food intake, hematological and clinical chemistry changes. Staining of the faeces in all test groups. Occasional hunched posture and dyspnoea in a few 30 mg/kg bw/day rats was noted. On day 57, 2 females from the 30 mg/Kg bw/day died due to misdosing. Females of the 30 mg/Kg bw/day showed reduced body weight from day 8 of treatment.With regard to body weight a statistically significant reduction was observed in females at 30 mg/kg/bw and at 10 mg/kg bw/d also a reduction was noted. In males only a slight reduction was observed at 30 mg/kg/bw. This was accompanied by reduced body weight gains in all these groups. In females at 30 mg/kg/bw also food consumption was reduced. Food intake was lowered in the 30 mg/Kg bw/day females in the last week. Dose related effects were noted in the hematological parameters.Haematological observations were reduction in red blood cells counts in both males and females which were statistically significant at 10 and 30 mg/kg bw/d for males and at 30 mg/kg bw/d for females. Furthermore, haematocrit values were slightly reduced in all dose groups in females. Further, the values for mean corpuscular haemoglobin (MCH) and mean corpuscular volume (MCV) were slightly increased in males and females of all dose groups. However, all changes were in the range of the historical controls.Dose related effects were noted in the clinical parameters.Some differences were observed with regard to Na, Ca, K, glucose, cholesterol as well as in the levels of alkaline phosphatase and aspartate aminotransferase. It was argued that all values were well within the range of historical controls. Relative organ weights were statistically significantly increased in x males and females at 30 m/kg bw/d for liver, kidneys and heart, the latter being additionally elevated (statistically significant) in males at 10 mg/kg bw/d. In addition, at 30 mg/kg bw slight increases were observed in relative testes weights in males and relative brain weights in females (both statistically significant). Despite the results of the statistical analyses of differences to controls, the differences were slight and all mean values remained well within the range of historical control data. The only organ in which a histopathological correlate was observed was the liver (centrilobular hepatocytic hypertrophy in five 10 mg/Kg bw/day males and in most high-dose males and females. Hepatocytic necrosis in one 30 mg/Kg bw/day male). Dark and firm areas in the liver in three 30 mg/Kg bw/day males. Centrilobular hepatocytic hypertrophy in five 10 mg/Kg bw/day males and in most 30 mg/Kg bw/day males and females. Hepatocytic necrosis in one 30 mg/Kg bw/day male. Nephropathy (tubular basophilia / dilatation and /or chronic inflammation) in five 10 mg/Kg bw/day males and six 30 mg/kg bw/day males. At the doses 30 and/or 10 mg/kg bw/day histopathological findings in liver and kidney indicate organ toxicity which is supported by changes in body and organ weights as well as in biochemical parameters (cholesterol, aspartate aminotransferase, alkaline phosphatase). Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for the test compound Basic violet 2 is considered to be 3 mg/Kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e0aa9d5-8dc0-47c7-8995-d8284fbdafad/documents/1ba2bf6a-e1ec-4436-9b25-e9d036f79e4b_66b4dd3c-71b1-4ac7-b5cc-84ed236abbdf.html,,,,,, "4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride",3248-91-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e0aa9d5-8dc0-47c7-8995-d8284fbdafad/documents/1ba2bf6a-e1ec-4436-9b25-e9d036f79e4b_66b4dd3c-71b1-4ac7-b5cc-84ed236abbdf.html,Chronic toxicity – systemic effects,oral,NOAEL,3 mg/kg bw/day,,rat "4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride",3248-91-7," Acute Oral Toxicity: The LD50 was estimated to be 26631 mg/kg bw,when male and female Sprague-Dawley rats were orally exposed with 4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride. Acute Dermal Toxicity: The LD50 was estimated to be 2713 mg/kg bw,when male New Zealand White rabbits were exposed with 4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride(3248-91-7) by dermal application. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e0aa9d5-8dc0-47c7-8995-d8284fbdafad/documents/de2e83ff-5c08-4fe1-9fa1-caa6eeb7b67d_66b4dd3c-71b1-4ac7-b5cc-84ed236abbdf.html,,,,,, "4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride",3248-91-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e0aa9d5-8dc0-47c7-8995-d8284fbdafad/documents/de2e83ff-5c08-4fe1-9fa1-caa6eeb7b67d_66b4dd3c-71b1-4ac7-b5cc-84ed236abbdf.html,,oral,LD50,"26,631 mg/kg bw",no adverse effect observed, "4-[(4-amino-m-tolyl)(4-imino-3-methylcyclohexa-2,5-dien-1-ylidene)methyl]-o-toluidine monohydrochloride",3248-91-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e0aa9d5-8dc0-47c7-8995-d8284fbdafad/documents/de2e83ff-5c08-4fe1-9fa1-caa6eeb7b67d_66b4dd3c-71b1-4ac7-b5cc-84ed236abbdf.html,,dermal,LD50,"2,713 mg/kg bw",no adverse effect observed, "[4-[4,4'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride",548-62-9," Repeated dose toxicity Oral: Combined repeated dose & carcinogenicity study was performed to determine the mutagenic nature of gentian violet. The study was performed using male and female Fischer F344 rats. Male and female weanling animals (F0) were randomly divided into four groups under barrier conditions and administered 0 (control), 100, 300 or 600 ppm (Males: 0, 30, 80 or 160 mg/Kg bw and females: 0, 40, 100 or 200 mg/Kg bw) GV in their feed for at least 80 days. All rats had access to feed and drinking-water ad lib. While receiving dosed feed, the females were mated with males (one male/ female) of the same dose level. Brother/sister matings were avoided. Two males and two females were selected randomly from each litter (F1a generation) and allocated three animals per cage as weanlings to the chronic study. Litter mates were not assigned to the same cage. The F1a animals continued on the same dose levels as their respective parents for 12, 18 or 24 months. The animals were observed for changes in body weight, food consumption, mortality and morbundity and the presence of lesions.   In females, the body weights increased gradually throughout the study in 0, 30, 80 or 160 mg/Kg bw dosed group. However, the rate of increase was lower in the 160 mg/Kg bw group. After about 85 wk, the body weight of animals fed the 80 mg/Kg bw increased at a lower rate than the 30 mg/Kg bw and control groups. In males, at 200 mg/Kg bw dose group, a lower average body weight was noted than those for any other dose group. Body weights of male rats of 40 and 100 mg/Kg bw groups peaked at about 460g at about 70wk and then started a gradual decline at about 85 wk.   Food consumption at week 1-20 showed a rapid decrease, then became stable, except for an unexplained increase after 90 wk. Consumption in the controls and test groups was essentially the same and stabilized at about 30-35 g food/kg body weight for the females and 25-30 g food/kg body weight for the males.   253 rats were found to be in the moribund stage throughout the study period. At the end of the dosing period, the mortality rates in the females were 33, 38, 60 and 66% for the controls and 30, 80 and 160 mg/Kg dose groups, respectively. For males, the same respective dose groups had mortality rates after 104 wk of 33, 33, 48 and 39% for 0, 40, 100 or 200 mg/kg bw. The mortality in females was significantly different from the controls at the 0.001 level in the 80 mg/Kg bw (P = 0.00007) and 160 mg/Kg bw groups (P= 0.00005). In males, only the 100 mg/Kg bw (P = 0.0057) had a higher mortality than the control animals at the 0.05 levels.   No dose-related pathology was noted in rats necropsied at 12 months. Although statistical analysis of the incidence of hepatocellular adenomas in females showed a significant difference in the 80 mg/Kg bw dose group, the incidence was very low and there was no significant difference in the 160 mg/Kg bw group. The incidence of follicular cell adenocarcinomas of the thyroid gland in female rats at the 24-month necropsy was 1, 1, 5 and 8% in the controls, and 30, 80 and 160 mg/Kg bw groups, respectively. The 80 and 160 mg/kg bw dose groups were significantly different from the controls. The incidence of mononuclear cell leukemia appeared to be a time-related response, that is, the leukemia showed a dose response in female rats administered GV in the diet for 18 months, but these effects were not observed in those rats necropsied at 24 months. Incidences of leukemia were high in all groups of female rats fed GV for 24 months and statistical analysis showed no significant differences overall or in the dose groups. In the males fed GV for 24 months, the only statistically significant differences from the controls for neoplastic lesions were noted in the 100 and 200 mg/Kg bw dosed groups for hepatocellular adenomas and in the high-dose group for follicular cell adenocarcinomas of the thyroid gland. The incidence of follicular cell adenocarcinomas of the thyroid gland in rats fed GV for 24 months was 1, 5, 3 and 6% in the controls and 40, 100 and 200 mg/Kg bw dosed groups, respectively. No incidence of mononuclear cell leukaemia show a dose response in male rats fed GV for either 18 or 24 months. No non neoplastic effects related to administration of the test substance were observed at the 12- and 18-month necropsies in male and female rats. Most non-neoplastic lesions in the female rats that showed a dose response at 24 months were located in the liver. Lesions in the liver included eosinophilic foci, haematopoietic cell proliferation, mixed cell foci, regeneration, centrilobular necrosis and bile duct hyperplasia. Innon-neoplastic lesions noted in the liver of male rats included clear cell foci, eosinophilic foci, mixed cell loci, regeneration and centrilobular necrosis. Lesions in other organs included follicle cyst of the thyroid gland, red pulp hyperplasia of the spleen and hyperplasia of the mesenteric lymph nodes.   Based on the observations made, the No Observed Adverse Effect level (NOAEL) for Gentian violet in male and female rats is considered to be 30 and 40 mg/Kg bw respectively. Repeated dose toxicity Inhalation: Gentian violet has a very low vapor pressure (2.57 X 10-12 Pa), so the potential for the generation of inhalable vapours is very low, also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Repeated dose toxicity Dermal: Repeated dose dermal toxicity study was performed to determine the dermal toxic nature of Gentian violet. The study was performed using female Charles River CD rats. 2 mL/Kg dye formulation P-23 containing 0.002% ( 0.00942 mg/Kg) test compound was applied to the dorso-scapular area. The application was made during the gestation days 1, 4, 7, 10, 13, 16 and 19. The animals were observed for clinical signs, body weight changes, dermal irritation if any and food consumption. No dye formulation related toxicity was noted.Changes in female body weights and food consumption were similar for rats in the untreated controls and all dye-treated groups. No irritation or other changes in appearance were noted except for changes in skin and hair color at the site of topical application of the dye formulation. Based on the observations made,the No Observed Adverse Effect Level (NOAEL) for gentian violet in female Charles River CD rats is considered to be 0.00942 mg/Kg. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/938f831b-508e-4bd5-9a8d-03cef08549b9/documents/e4992f9e-2c81-469b-a366-59f56d8035ae_994fdc08-8f82-4744-873c-6c55f0c0ffe1.html,,,,,, "[4-[4,4'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride",548-62-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/938f831b-508e-4bd5-9a8d-03cef08549b9/documents/e4992f9e-2c81-469b-a366-59f56d8035ae_994fdc08-8f82-4744-873c-6c55f0c0ffe1.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,0.009 mg/kg bw/day,,rat "[4-[4,4'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride",548-62-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/938f831b-508e-4bd5-9a8d-03cef08549b9/documents/e4992f9e-2c81-469b-a366-59f56d8035ae_994fdc08-8f82-4744-873c-6c55f0c0ffe1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "[4-[4,4'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride",548-62-9," Acute oral toxicity LD50 was estimated to be 711mg/kg bw, when male Fischer 344 rat were exposed with N-(4-{bis[4-(dimethylamino)phenyl]methylene}cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium chloride (548-62-9) orally. Acute inhalation toxicity Gentian violet has a very low vapor pressure (2.57 X 10-12 Pa), so the potential for the generation of inhalable vapours is very low, also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver Acute dermal toxicity LD50 was estimated to be 6869.69mg/kg bw, when male and female New Zealand White rabbits were exposed with N-(4-{bis[4-(dimethylamino)phenyl]methylene}cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium chloride (548-62-9) by dermal application. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/938f831b-508e-4bd5-9a8d-03cef08549b9/documents/306ff1d4-274b-4793-9c9d-aed1e56557c8_994fdc08-8f82-4744-873c-6c55f0c0ffe1.html,,,,,, "[4-[4,4'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride",548-62-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/938f831b-508e-4bd5-9a8d-03cef08549b9/documents/306ff1d4-274b-4793-9c9d-aed1e56557c8_994fdc08-8f82-4744-873c-6c55f0c0ffe1.html,,oral,LD50,711 mg/kg bw,adverse effect observed, "[4-[4,4'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium chloride",548-62-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/938f831b-508e-4bd5-9a8d-03cef08549b9/documents/306ff1d4-274b-4793-9c9d-aed1e56557c8_994fdc08-8f82-4744-873c-6c55f0c0ffe1.html,,dermal,LD50,"6,869.69 mg/kg bw",no adverse effect observed, "2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate",54060-92-3,"The toxicity of the test item, following daily oral administration by gavage for four consecutive weeks and recovery from any treatment related effects during a period of two weeks, was investigated in a study according to OECD 407. The NOAEL of 95 mg/kg bw/day based on the effects on mortality, body weight, food consumption, certain clinical chemistry parameters and organ weights seen in the high dose group. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8877ae2f-8147-4df0-9163-7eab80a29875/documents/IUC5-bf046355-576e-4ca0-b804-0930c284573f_10886bd7-d9fd-4144-a0a8-9c52437a929c.html,,,,,, "2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate",54060-92-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8877ae2f-8147-4df0-9163-7eab80a29875/documents/IUC5-bf046355-576e-4ca0-b804-0930c284573f_10886bd7-d9fd-4144-a0a8-9c52437a929c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,95 mg/kg bw/day,,rat "2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate",54060-92-3,"Two acute oral toxicity studies in rats are available, with a reported LD50 values of 841 mg/kg (Bonhard 1982) and 200-400 mg/kg (Ivens-Kohl 1989), respectively. Three acute inhalation toxicity studies in rats are available. Reported LC50 values are 0.29-0.47 mg/L (Pauluhn 1983) and 0.076 mg/L (Pauluhn 1993). The third study (Pauluhn 1994) was conducted with test item with very low dustability (below limit of detection). No mortality occurred based on a lack of exposure. Dermal toxicity was determined in rats exposed up to 2000 mg/kg bw (the study was conducted with a product containing 75% dye). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8877ae2f-8147-4df0-9163-7eab80a29875/documents/IUC5-39bf1850-d266-4258-8340-97e6da7cdb5b_10886bd7-d9fd-4144-a0a8-9c52437a929c.html,,,,,, "2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate",54060-92-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8877ae2f-8147-4df0-9163-7eab80a29875/documents/IUC5-39bf1850-d266-4258-8340-97e6da7cdb5b_10886bd7-d9fd-4144-a0a8-9c52437a929c.html,,oral,LD50,200 mg/kg bw,adverse effect observed, "2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate",54060-92-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8877ae2f-8147-4df0-9163-7eab80a29875/documents/IUC5-39bf1850-d266-4258-8340-97e6da7cdb5b_10886bd7-d9fd-4144-a0a8-9c52437a929c.html,,dermal,LD50,"1,500 mg/kg bw",adverse effect observed, "2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium methyl sulphate",54060-92-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8877ae2f-8147-4df0-9163-7eab80a29875/documents/IUC5-39bf1850-d266-4258-8340-97e6da7cdb5b_10886bd7-d9fd-4144-a0a8-9c52437a929c.html,,inhalation,LC50,76 mg/m3,adverse effect observed, "3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-N,N,N-trimethylanilinium chloride",68391-31-1," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical 3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4- yl)azo]-N,N,N-trimethylanilinium chloride/Basic Yellow 57 (CAS No. 68391-31-1) cannot be classified for acute oral toxicity.     Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical 3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4- yl)azo]-N,N,N-trimethylanilinium chloride/Basic Yellow 57 (CAS No. 68391-31-1) cannot be classified for acute dermal toxicity.     ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/180e4208-cfd8-459c-884d-bb256e5e5cb1/documents/1848859a-dd26-4132-b0bb-25939a5dbb30_832b60c1-96f1-45d7-8b7c-f208db498e35.html,,,,,, "3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-N,N,N-trimethylanilinium chloride",68391-31-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/180e4208-cfd8-459c-884d-bb256e5e5cb1/documents/1848859a-dd26-4132-b0bb-25939a5dbb30_832b60c1-96f1-45d7-8b7c-f208db498e35.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-N,N,N-trimethylanilinium chloride",68391-31-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/180e4208-cfd8-459c-884d-bb256e5e5cb1/documents/1848859a-dd26-4132-b0bb-25939a5dbb30_832b60c1-96f1-45d7-8b7c-f208db498e35.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Docosanamide,3061-75-4," RA-S CAS 112-84-5, Oral (OECD 408): NOAEL (subchronic) >= 1000 mg/kg bw/day (male/female) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/652db958-b65d-43a2-a44e-8809e820d522/documents/4f80adfd-2f9d-4036-a20e-0967ce03c27f_5a98117e-b9b3-4e34-8a6c-1ec89999df2e.html,,,,,, Docosanamide,3061-75-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/652db958-b65d-43a2-a44e-8809e820d522/documents/4f80adfd-2f9d-4036-a20e-0967ce03c27f_5a98117e-b9b3-4e34-8a6c-1ec89999df2e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Docosanamide,3061-75-4,"RA-S CAS 112-84-5, OECD 423, rat: LD50 > 2500 mg/kg bwRA-S CAS 112-84-5, OECD 436, rat: LC50 > 2800 mg/m³ (highest feasible aerosol concentration with respirable MMAD)RA-S CAS 112-84-5, OECD 402, rat: LD50 > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/652db958-b65d-43a2-a44e-8809e820d522/documents/f129cc76-2009-489c-8c06-a47497ecd118_5a98117e-b9b3-4e34-8a6c-1ec89999df2e.html,,,,,, Docosanamide,3061-75-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/652db958-b65d-43a2-a44e-8809e820d522/documents/f129cc76-2009-489c-8c06-a47497ecd118_5a98117e-b9b3-4e34-8a6c-1ec89999df2e.html,,oral,LD50,"> 2,500 mg/kg bw",no adverse effect observed, Docosanamide,3061-75-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/652db958-b65d-43a2-a44e-8809e820d522/documents/f129cc76-2009-489c-8c06-a47497ecd118_5a98117e-b9b3-4e34-8a6c-1ec89999df2e.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Docosanamide,3061-75-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/652db958-b65d-43a2-a44e-8809e820d522/documents/f129cc76-2009-489c-8c06-a47497ecd118_5a98117e-b9b3-4e34-8a6c-1ec89999df2e.html,,inhalation,LC50,"> 2,800 mg/m3",no adverse effect observed, N-[3-(dimethylamino)propyl]docosanamide,60270-33-9," - subacute 4-week study; oral (gavage), rat (Sprague-Dawley); 5 rats/dose/sex in the groups treated with 30 and 60 mg/kg bw/d, 10 rats/dose/sex in the control group and in the group treated with 120 mg/kg bw/d., OECD TG 407, GLP; NOAEL = 60 mg/kg bw/day (based on lower food intake and slight reduction in body weight gain at 120 mg/kg bw/day); read-across: N-[3-(dimethylamino)propyl] C12-C18 alkylamide - Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test, 10 Wistar rats/sex/dose by gavage at dose levels of 0, 5, 15 and 45 mg/kg bw/d; Males were exposed for 28 days, Females were exposed for 54 days, according to OECD guideline 422, GLP; NOAEL(reproduction/development) = 45 mg/kg; NOAEL(parental toxicity) = 15 mg/kg bw/d (increased salivation, reduced body weight gain at 45 mg/kg bw/d); read-across: N-[3-(dimethylamino)propyl] C12-C18 alkylamide   - subchronic 90 d study; oral (gavage), rat (Crl:WI (Han)); 10/sex/dose; 0, 15, 30, 60 mg/kg bw/d; OECD TG 408, GLP; NOAEL systemic effects: 60 mg/kgbw/day (no signs of systemic toxicity); NOAEL local effects: 15 mg/kg bw/day (local effects in the non-glandular stomach) ; read-across: N-[3-(dimethylamino)propyl] C12-C18 alkylamide ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff109042-a156-45d2-86fe-f0b27e6899df/documents/IUC5-c29b2c63-9f85-4619-87c9-c0ec04af2581_c118aaed-fd4d-43ed-9450-abacc2da43c6.html,,,,,, N-[3-(dimethylamino)propyl]docosanamide,60270-33-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff109042-a156-45d2-86fe-f0b27e6899df/documents/IUC5-c29b2c63-9f85-4619-87c9-c0ec04af2581_c118aaed-fd4d-43ed-9450-abacc2da43c6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat N-[3-(dimethylamino)propyl]docosanamide,60270-33-9,"Data on acute toxicity is not available for the target substance DIMAPDO. For the assessment of acute effects of DIMAPDO the results from the following study is taken into consideration: Acute oral toxicity: LD50 expected to be > 2000 mg/kg bw based on a read-across study with the source substance N-[3-(dimethylamino)propyl]stearamide (C18) and N-[3-(dimethylamino)propyl] docosanamide (C22) 50:50 (w/w %) according to OECD Guideline 423, GLP compliant ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff109042-a156-45d2-86fe-f0b27e6899df/documents/IUC5-806ceda8-0df3-4011-8bfc-e1d58ef12cb2_c118aaed-fd4d-43ed-9450-abacc2da43c6.html,,,,,, N-[3-(dimethylamino)propyl]docosanamide,60270-33-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff109042-a156-45d2-86fe-f0b27e6899df/documents/IUC5-806ceda8-0df3-4011-8bfc-e1d58ef12cb2_c118aaed-fd4d-43ed-9450-abacc2da43c6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, N-[3-(dimethylamino)propyl]docosanamide,60270-33-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff109042-a156-45d2-86fe-f0b27e6899df/documents/IUC5-806ceda8-0df3-4011-8bfc-e1d58ef12cb2_c118aaed-fd4d-43ed-9450-abacc2da43c6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Docosanoic acid,112-85-6,"Key studies on oral repeated dose toxicity are available for the following category members:Subchronic (84 days, rat): NOAEL oral ≥ 12500 mg/kg bw/day; CAS# 112-80-1, C18:1 (Calandra, 1969)Subacute (OECD 422, rat): NOAEL oral ≥ 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao et al., 2002)In conclusion, no human hazard for systemic toxicity after repeated oral exposure was identified for the members of the fatty acids category.No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/247546dd-2632-492c-882d-b7b060725837/documents/be0a258e-21d8-463f-946b-161cd679a57c_325ba199-d633-4024-aa55-22386d9ded7d.html,,,,,, Docosanoic acid,112-85-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/247546dd-2632-492c-882d-b7b060725837/documents/be0a258e-21d8-463f-946b-161cd679a57c_325ba199-d633-4024-aa55-22386d9ded7d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"12,500 mg/kg bw/day",,rat Docosanoic acid,112-85-6,"Oral (OECD 401, limit test), rat: LD50 >5000 mg/kg bw (Gloxhuber and Kästner, 1981)Oral (OECD 401, limit test), rat: LD50 >2000 mg/kg bw (Ohara, 2002)Inhalation, IRT, rat, 8h: LC50 >1.3682 mg/L air; CAS# 142-62-1, C6 (Smyth et al., 1954)Dermal (OECD 402, limit test), rat: LD50 >2000 mg/kg bw ; CAS# 112-05-0, C9 (van Otterdijk, 2001)Dermal (OECD 402, limit test), rat: LD50 >2000 mg/kg bw; CAS# 111-20-6, C10d (Yu, 1999)Dermal (OECD 402, limit test), rat: LD50 >2000 mg/kg bw; CAS# 334-48-5, C10 (TalviOja, 2006) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/247546dd-2632-492c-882d-b7b060725837/documents/a1b45cb7-dd66-4b34-9cdb-3f1a6e5876ca_325ba199-d633-4024-aa55-22386d9ded7d.html,,,,,, Docosanoic acid,112-85-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/247546dd-2632-492c-882d-b7b060725837/documents/a1b45cb7-dd66-4b34-9cdb-3f1a6e5876ca_325ba199-d633-4024-aa55-22386d9ded7d.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Docosanoic acid,112-85-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/247546dd-2632-492c-882d-b7b060725837/documents/a1b45cb7-dd66-4b34-9cdb-3f1a6e5876ca_325ba199-d633-4024-aa55-22386d9ded7d.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Docosyltrimethylammonium methyl sulphate,81646-13-1,"Repeated oral toxicity:A similar supporting substance was tested in a 28-day oral gavage study in rats that received daily doses of 0, 10, 50 and 150 mg/kg/day. One male of the high dose group died and two females of the high dose group had to be humanely killed during the treatment period. In a dose dependent fashion, animals at 50 and 150 mg/kg/day showed various effects on body weight, hematology, clinical chemistry, organ weights, macroscopic and microscopic examination. In animals at 10 mg/kg/day, mesenteric lymph nodes were affected to a minimal or mild degree only and no further treatment-related changes were noted in these animals. Therefore, a No Observed Adverse Effect Level (NOAEL) for the test substance of 10 mg/kg/day was established. The 28-day study results are supported by an OECD 421 study with the same substance that reported a parental NOAEL of 30 mg/kg/day.Additional data on similar supporting substances was also considered. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a7b95da-1bbb-46b5-b408-c6fa8a73b732/documents/IUC5-4a22507b-bd8e-4000-bc97-7dc8876f8b14_5f194d83-3077-4d67-9c43-0d21a43eb32c.html,,,,,, Docosyltrimethylammonium methyl sulphate,81646-13-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a7b95da-1bbb-46b5-b408-c6fa8a73b732/documents/IUC5-4a22507b-bd8e-4000-bc97-7dc8876f8b14_5f194d83-3077-4d67-9c43-0d21a43eb32c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Docosyltrimethylammonium methyl sulphate,81646-13-1,Acute oral toxicityThe LD50 in female Wistar rats after a single oral application of the similar supporting substance C20-22-alkyltrimethylammonium chloride was 3190 mg/kg bw.Acute dermal toxicity:In a weight-of-evidence approach data on acute dermal toxicity of similar substances were used together with information on dermal absorption and taking into consideration the low acute oral toxicity of the substance. From this combined evidence it can be concluded that the acute dermal toxicity is >2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a7b95da-1bbb-46b5-b408-c6fa8a73b732/documents/IUC5-39839cf7-3139-4b6e-93ef-55d8515c953d_5f194d83-3077-4d67-9c43-0d21a43eb32c.html,,,,,, Docosyltrimethylammonium methyl sulphate,81646-13-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a7b95da-1bbb-46b5-b408-c6fa8a73b732/documents/IUC5-39839cf7-3139-4b6e-93ef-55d8515c953d_5f194d83-3077-4d67-9c43-0d21a43eb32c.html,,oral,LD50,"3,190 mg/kg bw",adverse effect observed, Docosyl acrylate,18299-85-9,"Oral  In two combined repeated oral dose and reproductive / developmental toxicity screening studies (OECD 422) in rats the structural analogues 2-Propenoic acid, C12-14-alkyl esters and 2-Propenoic acid, C18-22-alkyl esters showed no toxicity up to the highest administered dose of 1000 mg/kg bw/day (see table 1).  Table 1. Data on repeated oral dose toxicity     Ester   Method   Species   NOAEL   Reference 2-Propenoic acid, C12-14- alkyl esters     OECD TG 422   Rats   1000 mg/kg bw/day (highest dose tested)   BASF SE 2013 2-Propenoic acid, C18-22- alkyl esters     OECD TG 422   Rats   1000 mg/kg bw/day (highest dose tested) BASF SE 2013 The available data from the group of long-chain acrylate esters for repeated dose toxicity cover the shortest and longest chain lengths present in the category. Within both studies the NOAEL was 1000 mg/kg bw/d the highest dose tested and the limit dose for this kind of study.  The long-chain alky acrylates have a decreasing bioavailability with increasing chain length. As described in the chapter 7.1. Toxicokinetics in silico and in vitro studies were performed to address this.  A PBPK model using The Simcyp Animal Simulator Version 22 Release 1 (Certara UK, Hartley, 2023)) was used for PBPK simulations of ethyl acrylate, 2-ethylhexyl acrylate, dodecyl acrylate, tetradecyl acrylate, hexadecyl acrylate, octadecyl acrylate, Icosyl acrylate and docosyl acrylate. A whole body PBPK model, which allows for the addition of further specific organs, or a minimal PBPK model was used in simulations. The expected low gastrointestinal and systemic uptake was confirmed in this in silico PBPK modelling. For dodecyl acrylate, tetradecyl acrylate, hexadecyl acrylate, octadecyl acrylate; icosyl acrylate and docosyl acrylate the predicted fraction absorbed was 0.81, 0.71, 0.015, 0.0001, 0.0022, and 0.0006, respectively. In addition, an in vitro intestinal absorption test with acrylates in the EpiIntestinal model was performed with dodecyl acrylate, hexadecyl acrylate, octadecyl acrylate and docosyl acrylate (BASF SE, 2024). The results of this in vitro intestinal absorption test (EpiIntestinal model) indicate that none of the four compounds (dodecyl acrylate , hexadecyl acrylate, octadecyl acrylate and docosyl acrylate) crosses the intestinal barrier. Based on the results regarding the hydrolysis and metabolism of the compounds to the corresponding alcohols, we identified a considerable transfer of 1-dodecanol (6.3%) and a marginal transfer of 1-hexadecanol (0.4%) to the receptor chamber, indicating that hydrolysis products of short chain acrylates might cross the intestinal barrier. In the in vitro intestinal absorption test the concentration of dodecyl acrylate of 5 mM (limited by cytotoxicity in higher concentrations) equates to a dose of 509.6 mg/kg BW, the concentration of hexadecyl acrylate, octadecyl acrylate and docosyl acrylate of 100 mM equates to doses of 12572, 13760 and 16140 mg/kg BW, respectively, which markedly exceeds the in vivo limit dose of 1000 mg/kg BW (repeated dose toxicity / reproduction toxicity). Taken together, it can be postulate that under realistic exposure scenarios no physiologically relevant uptake of the long-chain alkyl acrylates occurs. Based on this data it can be expected that dodecyl acrylate, the category member with the shortest alkyl chain has a low likelihood to be bioavailable after oral uptake. Whereas for the other category members the bioavailiability after oral uptake can be regarded to be negligible. Therefore, the registrant proposes to perform a subchronic study, according to OECD TG 408 with dodedyl acrylate to support the data requirements according to REACH Annex IX. In addition, a repeated oral dose and reproductive / developmental toxicity screening studies according to OECD TG 422 is ongoing with hexadecyl acrylate to support the hypothesis.   Inhalation  The inhalation route is not of relevance due to the very low vapour pressure of the substances (see chapter on Toxicokinetics).  Dermal  The experimental repeated dose oral toxicity data demonstrated in accordance with acute dermal and oral tests the low toxicity of the long-chain alkyl esters. In addition, the characteristics of skin penetration and metabolism in the skin show the limited bioavailability of the esters via the dermal route (see chapter on Toxicokinetics). Therefore, the potential for repeated dermal dose toxicity can be considered low.  Conclusion  In conclusion, the long-chain alkyl acrylate esters (C12 – C22) showed no oral toxicity after repeated application. Studies available are considered to be reliable and suitable to cover the endpoint repeated dose toxicity and fulfil the REACH information requirements of Annex VIII / IX, section 8.6.  The variable part of the category approach is the length and/or configuration of the side chain of the parent ester and the alcohol metabolite, as well as their impacts on physico-chemical properties and consequent biological properties. Despite these variations, the available data support a lack of systemic toxicity for all the category members, since data is availablefor the shortest and longest chain lengths present in the category. These repeated dose toxicity studies have also reported a similar and common profile of target organs (i.e. a lack of systemic toxicity). Thus, the results of the collection of these studies conducted on these substances are consistent and can be regarded as offering a true picture of repeated dose toxicity for the category. In order to fill the data-gap for the mono-constituents, a category based read-across is applied to the repeated dose toxicity studies available for oral route. Overall, the read-across approach is applied with a high level of confidence.    Therefore, the registrant proposes to perform a subchronic study, according to OECD TG 408 with dodedyl acrylate to support the data requirements according to REACH Annex IX. In addition, a repeated oral dose and reproductive / developmental toxicity screening studies according to OECD TG 422 is ongoing with hexadecyl acrylate to support the hypothesis of negligible bioavailability. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96027cb1-4681-4f9f-b88d-6a1f546e901d/documents/62562159-15e1-4017-a3a0-b4af8f24417b_c256aa5a-cdee-4981-bb01-0ab6c53c1bca.html,,,,,, Docosyl acrylate,18299-85-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96027cb1-4681-4f9f-b88d-6a1f546e901d/documents/62562159-15e1-4017-a3a0-b4af8f24417b_c256aa5a-cdee-4981-bb01-0ab6c53c1bca.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Docosyl acrylate,18299-85-9,"Three oral toxicity studies conducted with mixtures of long-chain acrylate esters and one study with octadecyl acrylate (C18) showed no acute toxicity after oral exposure (see table 1).   Table 1 . Acute oral toxicity data from the source substances    Ester   Method   Species   LD50   Reference 2-Propenoic acid, C16-18-alkyl esters     OECD TG 423   Rats   > 2000 mg/kg bw   BASF SE 2012 Octadecyl acrylate   EU B.1 Rats > 5000 mg/kg bw BASF SE 1985 2-Propenoic acid, C18-22-alkyl esters     OECD TG 423   Rats   > 2000 mg/kg bw   BASF SE 2012 2-Propenoic acid, C12-14-alkyl esters   OECD TG 401 Rats > 5570 mg/kg bw BASF AG 1964 The available data from the group of long-chain acrylate esters for the oral route cover all chain lengths present in the category. They are consistent and sufficient to enable an assessment for this endpoint.  Inhalation  The inhalation route is not of relevance due to the low vapour pressure of the substances (see chapter on Toxicokinetics).  Dermal  Three dermal toxicity studies conducted with mixtures of long-chain acrylate esters showed no acute toxicity after dermal application (see table 2 ).  Table 2 . Acute dermal toxicity data from the source substances  Ester Method Species LD50 Reference 2-Propenoic acid, C12-14-alkyl esters   OECD TG 402 Rat > 5000 mg/kg bw BASF SE 2012 2-Propenoic acid, C16-18-alkyl esters       OECD TG 402     Rat     > 5000 mg/kg bw     BASF SE 2012 2-Propenoic acid, C18-22-alkyl esters   OECD TG 402 Rat > 5000 mg/kg bw BASF SE 2012 The available data from the group of long-chain acrylate esters for the dermal route cover all chain lengths present in the category. They are consistent and sufficient to enable an assessment for this endpoint.    ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96027cb1-4681-4f9f-b88d-6a1f546e901d/documents/8c5112d2-f71a-4b65-88ef-232eab77c71b_c256aa5a-cdee-4981-bb01-0ab6c53c1bca.html,,,,,, Docosyl acrylate,18299-85-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96027cb1-4681-4f9f-b88d-6a1f546e901d/documents/8c5112d2-f71a-4b65-88ef-232eab77c71b_c256aa5a-cdee-4981-bb01-0ab6c53c1bca.html,,oral,discriminating dose,"5,570 mg/kg bw",no adverse effect observed, Docosyl acrylate,18299-85-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96027cb1-4681-4f9f-b88d-6a1f546e901d/documents/8c5112d2-f71a-4b65-88ef-232eab77c71b_c256aa5a-cdee-4981-bb01-0ab6c53c1bca.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Docosyl acrylate,18299-85-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96027cb1-4681-4f9f-b88d-6a1f546e901d/documents/8c5112d2-f71a-4b65-88ef-232eab77c71b_c256aa5a-cdee-4981-bb01-0ab6c53c1bca.html,,inhalation,discriminating conc.,690 mg/m3,no adverse effect observed, Docosan-1-ol,661-19-8," A reliable 90-days dietary study in rats, using hexadecan-1-ol and reporting a NOAEL value greater than 4400 mg/kg bw/day based on no observed adverse effects is read-across (Scientific Assoc, 1966a; rel. 2) There is also a reliable 26-week oral gavage study available on the registered substance docosan-1-ol that reported no adverse effects at the highest dose tested, 1000 mg/kg bw/day (Iglesias et al., 2002a). Both studies are used as weight of evidence but as no adverse systemic effects were observed for category members, the study using the highest dose from the available data was considered as the basis for classification. Therefore, the 90-day dietary study conducted with the structurally analogous substance hexadecan-1-ol is used to derive the NOAEL for docosan-1-ol. A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test is commissioned with the registered substance and will be conducted according to OECD Test Guideline 422 and in compliance with GLP. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b24ecb7-5525-4f6d-be7f-db18f1812b29/documents/d7ad7c1c-d5f0-40cc-85d4-a427f8b2b181_2ed7d09e-6b88-4b01-a66c-c8c560a9f34c.html,,,,,, Docosan-1-ol,661-19-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b24ecb7-5525-4f6d-be7f-db18f1812b29/documents/d7ad7c1c-d5f0-40cc-85d4-a427f8b2b181_2ed7d09e-6b88-4b01-a66c-c8c560a9f34c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"4,400 mg/kg bw/day",,rat Docosan-1-ol,661-19-8," The key acute oral toxicity study for docosan-1-ol, conducted according to OECD Test Guidelie 423, and in compliance with GLP, reports an LD50 value of > 2000 mg/kg bw (Safepharm Laboratories, 1997).  The key acute dermal toxicity study is read-across from the structurally analogous substance icosan-1-ol (CAS 629-96-9, EC 211-119-4). The study was conducted according to generally acceptable scientific principles, and prior to GLP. The study reports an LD50 value of > 16800 mg/kg (Smyth, 1969). No testing is required via inhalatory route since high reliability studies are already in place via the oral and dermal route. Furthermore, the LC50 for inhalation is expected to be greater than the substantially saturated vapour concentration based on weight of evidence across category. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b24ecb7-5525-4f6d-be7f-db18f1812b29/documents/d1178676-e712-4c39-9266-bda2386909a3_2ed7d09e-6b88-4b01-a66c-c8c560a9f34c.html,,,,,, Docosan-1-ol,661-19-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b24ecb7-5525-4f6d-be7f-db18f1812b29/documents/d1178676-e712-4c39-9266-bda2386909a3_2ed7d09e-6b88-4b01-a66c-c8c560a9f34c.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Docosan-1-ol,661-19-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b24ecb7-5525-4f6d-be7f-db18f1812b29/documents/d1178676-e712-4c39-9266-bda2386909a3_2ed7d09e-6b88-4b01-a66c-c8c560a9f34c.html,,dermal,LD50,"> 16,800 mg/kg bw",no adverse effect observed, Docosyl docosanoate,17671-27-1," Short-term (28-day) repeated dose toxicity (OECD 422): NOAEL = 1000 mg/kg bw/day Study performed with the analogue source substance fatty acids C20-22 (even numbered), C18-22 (even numbered) alkyl esters (EC 701-233-7) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e82d10f-3e85-4776-9fb4-2a0d566c93bc/documents/b76146dd-a975-46b6-9d31-b0bc5b380dbe_a5afc1bc-8fc6-4c71-8640-813a7d3eb78a.html,,,,,, Docosyl docosanoate,17671-27-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e82d10f-3e85-4776-9fb4-2a0d566c93bc/documents/b76146dd-a975-46b6-9d31-b0bc5b380dbe_a5afc1bc-8fc6-4c71-8640-813a7d3eb78a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Docosyl docosanoate,17671-27-1," Oral (OECD 423, limit test): LD50 (rat, f) > 2000 mg/kg bw Study performed with the analogue source substance fatty acids C20-22 (even numbered), C18-22 (even numbered) alkyl esters (EC 701-233-7) Inhalation (OECD 436): LD50 > 5.7 mg/L air Study performed with the analogue source substance 2-ethylhexyl oleate (CAS 26399-02-0) Dermal (OECD 402): LD50 > 2000 mg/kg bw Study performed with the analogue source substance decyl oleate (CAS 3687-46-5) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e82d10f-3e85-4776-9fb4-2a0d566c93bc/documents/4a7f94b5-eed2-4ea4-b0de-181383ee5492_a5afc1bc-8fc6-4c71-8640-813a7d3eb78a.html,,,,,, Benzaldehyde,100-52-7,"Repeated dose studies with the test substance are available. A 16 -day oral range finding study in rats (NTP, 1990): no effects were found upto doses of 400 mg/kg bw/day. A 16 -day oral range finding study in mice (NTP, 1990): no effects were found upto doses of 400 mg/kg bw/day. A 13 -week oral range finding study in rats (Kluwe, 1982): no effects were found at 400 m/kg bw/day (effects at 800 mg/kg bw/day). A 13 -week oral range finding study in mice (Kluwe, 1982): no effects were found at 300 mg/kg bw/day (effects at 600 mg/kg bw/day) for males and 600-1200 mg/kg bw/day (effects at 1200 mg/kg bw/day) for females. In a 16 -week oral toxicity study in rats (Hagan, 1966), a NOAEL of 500 mg/kg bw/day was established. A chronic (carcinogenicity) study in rats (NTP, 1990) with a NOAEL of 400 mg/kg bw.A chronic (carcinogenicity) study in mice (NTP, 1990): effects at 300 mg/kg bw (LOAEL).LOAEL converted to NOAEL using an assessment factor of 3.Based on route-to-route extrapolation from the oral LOAEL assuming an oral and dermal absorption of 100%, the NOAEL for dermal toxicity will be 100 mg/kg bw/day.In a subacute inhalation study in rats (Lahan, 1991), a NOAEC could not be derived, since effects of the test substance were noted in all treatment groups. Clinical observations (indicative of neurotoxicity), hypothermia and goblet cell metaplasia were noted at concentrations of 500 ppm and above. Therefore, the LOAEC is established at 500 ppm (equivalent to 2.2 mg/L and 2200 mg/m3).   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea4fba40-464c-41c8-8fb0-6af106cf5eb6/documents/13b20f19-dd22-4b17-946a-0c4ca7a03a16_0f531a0f-eaaa-49a4-bf5d-035d9c266ded.html,,,,,, Benzaldehyde,100-52-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea4fba40-464c-41c8-8fb0-6af106cf5eb6/documents/13b20f19-dd22-4b17-946a-0c4ca7a03a16_0f531a0f-eaaa-49a4-bf5d-035d9c266ded.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,"2,200 mg/m3",,rat Benzaldehyde,100-52-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea4fba40-464c-41c8-8fb0-6af106cf5eb6/documents/13b20f19-dd22-4b17-946a-0c4ca7a03a16_0f531a0f-eaaa-49a4-bf5d-035d9c266ded.html,Chronic toxicity – systemic effects,oral,LOAEL,300 mg/kg bw/day,,mouse Benzaldehyde,100-52-7,"Several studies on the acute toxicity of the test substance are available. Based on a weight of evidence, a conclusion on the acute oral toxicity of the test substance is drawn. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea4fba40-464c-41c8-8fb0-6af106cf5eb6/documents/f7705b94-f77c-4d1c-9604-e2d4c08248b4_0f531a0f-eaaa-49a4-bf5d-035d9c266ded.html,,,,,, Benzaldehyde,100-52-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea4fba40-464c-41c8-8fb0-6af106cf5eb6/documents/f7705b94-f77c-4d1c-9604-e2d4c08248b4_0f531a0f-eaaa-49a4-bf5d-035d9c266ded.html,,oral,LD50,"1,430 mg/kg bw",adverse effect observed, Benzaldehyde,100-52-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea4fba40-464c-41c8-8fb0-6af106cf5eb6/documents/f7705b94-f77c-4d1c-9604-e2d4c08248b4_0f531a0f-eaaa-49a4-bf5d-035d9c266ded.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Benzaldehyde,100-52-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea4fba40-464c-41c8-8fb0-6af106cf5eb6/documents/f7705b94-f77c-4d1c-9604-e2d4c08248b4_0f531a0f-eaaa-49a4-bf5d-035d9c266ded.html,,inhalation,discriminating conc.,"1,000 mg/m3",adverse effect observed, 3-benzylidenephthalide,575-61-1,The obtained results are disregarded as the substance is out from the applicability domain of the model. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2aa853b6-ed25-49a6-9fe9-de2dcb6fb895/documents/IUC5-e4e978c6-b978-44a0-b654-f42721ef6a30_b2b6a051-c762-4b90-aeab-76406ad45bec.html,,,,,, Benzethonium chloride,121-54-0," Repeated dose toxicity In a 28d feeding study, continuous feeding of benzethonium chloride to rats at various dietary levels up to 2500 ppm resulted in a number of changes (e.g. body weights, hematology, biochemistry, urinalysis, organ weights) in the top-dose group. From the results obtained in the present study it was concluded that the no-observed-effect level NOEL of benzethonium chloride was 500 ppm in the diet of rats for 4 weeks. This level was equivalent to an intake of about 40 mg benzethonium chloride/kg body weight/day. In further subchronic studies, little or no toxic effects were found when Benzethonium Chloride was administered orally or percutaneously. The maximum tolerated dose of Benzethonium Chloride administered subcutaneously was 3.0 and 35 mg/kg in rats and mice, respectively. Chronic oral studies were also generally negative for toxic effects due to Benzethonium Chloride except for a slight increase in mortality and reduced body weight in rats at the high dietary concentration (5000 ppm) in one study. Greatly enlarged ceca were also noted in this latter study. In 1 of 2 chronic subcutaneous studies on Benzethonium Chloride, reduced weight gain was found at the high dose only, and a 13 percent incidence of sarcomas at injection sites was dose related. Source: CIR-Report (Lit: Journal of the American College of Toxicology, Volume 4, Number 5, 1985, Mary Ann Liebert, Inc., Publishers) GLP-report (owner: Lonza) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e6a61a0-44f7-4f9a-8949-c305db740fd0/documents/5a78a07a-4d9c-4359-80e8-9d86035810a7_db779c0b-c366-47b3-98bb-0f54f8d98901.html,,,,,, Benzethonium chloride,121-54-0," Acute oral toxicity The key study was performed on rats in accordance with EPA test guidelines no. 798.1175. Based on the mortality observed during the definitive study, the oral LD50 value was calculated to be 295 mg/kg with 95% Confidence Limits of 160 and 543 mg/kg. Acute dermal toxicity The test item, at a concentration of 10% in water, when placed on intact skin of albino rabbits for periods of 2 or 24 hours resulted in erythema and edema followed by scaling; no effects were observed with a 0.5 hour contact time. Reaction of abraded skin was more severe at all contact times (0.5, 2 and 24 hours) as evidenced by erythema and edema followed by eschar formation, which began to separate in the second week exposing apparently normal skin underneath (Source: Lit: Department of Pharmacology, Medical College of Virginia, Aug. 7, 1969) A number of additional acute toxicity studies (topical, subcutaneous,intraperitoneal, intravenous application) can be found in literature. In those toxicity studies, Benzethonium Chloride was moderately to slightly toxic when administered orally or intraperitoneally and mildly toxic to mice treated intranasally with concentrations of 0.25 to 4 percent. The subcutaneous LD50 for Benzethonium Chloride was 119.0 mg/kg in rats and the intravenous LD50 was 35 and 19.1 mg/kg in mice and rats, respectively (Source: CIR-Report (Lit: Journal of the American College of Toxicology, Volume 4, Number 5, 1985, Mary Ann Liebert, Inc., Publishers)) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e6a61a0-44f7-4f9a-8949-c305db740fd0/documents/e4a30f15-e3c8-4191-99d4-803d8e47e497_db779c0b-c366-47b3-98bb-0f54f8d98901.html,,,,,, Benzethonium chloride,121-54-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e6a61a0-44f7-4f9a-8949-c305db740fd0/documents/e4a30f15-e3c8-4191-99d4-803d8e47e497_db779c0b-c366-47b3-98bb-0f54f8d98901.html,,oral,LD50,295 mg/kg bw,adverse effect observed, Benzimidazole,51-17-2," Repeated dose toxicity: Oral The No Observed Adverse Effect Level (NOAEL) of the test chemical 1H-benzimidazole using rats via oral route, is considered to be 200 mg/kg body weight. Repeated dose toxicity: Inhalation 1H-benzimidazole (CAS no 51-17-2) has very low vapour pressure (7.6x10-5 mmHg = 0.01018 Pa.). Also the particle size distribution was determined to be in the range of 150 micron to 25 micron. So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the end point for repeated dose toxicity by oral route was considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value for 1H-benzimidazole (CAS no 51-17-2) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b86c9d94-ffbd-4238-89d5-cb8cbc173a33/documents/2d5a1389-645b-484b-81eb-e6b10e50e6f9_e60f9933-24c4-41a8-b184-eb0d1feed8cf.html,,,,,, Benzimidazole,51-17-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b86c9d94-ffbd-4238-89d5-cb8cbc173a33/documents/2d5a1389-645b-484b-81eb-e6b10e50e6f9_e60f9933-24c4-41a8-b184-eb0d1feed8cf.html,Chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Benzimidazole,51-17-2," Acute oral Toxicity:  In Acute oral toxicity,LD50 value for target substance1H-benzimidazole(51-17-2)was estimated to be 640 mg/kg bw in rats.Thus, based on the predictions on 1H-benzimidazole, it can be concluded that LD50 value is between 300-2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 1H-benzimidazole can be classified as ‘Category IV’ of acute oral toxicity. Acute Inhalation Toxicity:  1H-benzimidazole (51-17-2) has very low vapour pressure (7.6x10-5 mmHg = 0.01018 Pa.),So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver. Acute Dermal Toxicity: The acute dermal toxicity dose (LD50) for 1H-benzimidazole (51-17-2) was based on data available for the structurally and functionally similar read across chemicals. The LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 1H-benzimidazole (51-17-2) cannot be classified for acute dermal toxicity.  ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b86c9d94-ffbd-4238-89d5-cb8cbc173a33/documents/78853f0d-cbf2-44e4-a29e-4abd5781e274_e60f9933-24c4-41a8-b184-eb0d1feed8cf.html,,,,,, Benzimidazole,51-17-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b86c9d94-ffbd-4238-89d5-cb8cbc173a33/documents/78853f0d-cbf2-44e4-a29e-4abd5781e274_e60f9933-24c4-41a8-b184-eb0d1feed8cf.html,,oral,LD50,640 mg/kg bw,adverse effect observed, Benzimidazole,51-17-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b86c9d94-ffbd-4238-89d5-cb8cbc173a33/documents/78853f0d-cbf2-44e4-a29e-4abd5781e274_e60f9933-24c4-41a8-b184-eb0d1feed8cf.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,2-benzisothiazol-3(2H)-one",2634-33-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fc092af-9ef1-4af6-aaf9-ee8ddc0a27e3/documents/969b0a11-1d21-4da4-a11b-7287d6123d6b_db9299b3-6d73-4b36-b6be-cd0e3841438b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,69 mg/kg bw/day,,rat "1,2-benzisothiazol-3(2H)-one",2634-33-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fc092af-9ef1-4af6-aaf9-ee8ddc0a27e3/documents/6e29fb4e-d30e-4e59-bc80-ffa1c9c98302_db9299b3-6d73-4b36-b6be-cd0e3841438b.html,,oral,LD50,490 mg/kg bw,adverse effect observed, "1,2-benzisothiazol-3(2H)-one",2634-33-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fc092af-9ef1-4af6-aaf9-ee8ddc0a27e3/documents/6e29fb4e-d30e-4e59-bc80-ffa1c9c98302_db9299b3-6d73-4b36-b6be-cd0e3841438b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "6-phenyl-1,3,5-triazine-2,4-diyldiamine",91-76-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study is a GLP compliant and has Klimisch score 1. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30070ff3-fb68-478e-a56c-503d83ea6c2b/documents/IUC5-845e2fa6-11da-4ef1-9e72-cd1a7e73eb8b_6467afaa-e03f-4820-90e4-c7559468dc23.html,,,,,, "6-phenyl-1,3,5-triazine-2,4-diyldiamine",91-76-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30070ff3-fb68-478e-a56c-503d83ea6c2b/documents/IUC5-845e2fa6-11da-4ef1-9e72-cd1a7e73eb8b_6467afaa-e03f-4820-90e4-c7559468dc23.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,19 mg/kg bw/day,,rat "6-phenyl-1,3,5-triazine-2,4-diyldiamine",91-76-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is a GLP compliant and has Klimisch score 1. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The study is a GLP compliant and has Klimisch score 1. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30070ff3-fb68-478e-a56c-503d83ea6c2b/documents/IUC5-5e26d2c0-a02a-44ee-b95d-78d723713c92_6467afaa-e03f-4820-90e4-c7559468dc23.html,,,,,, "6-phenyl-1,3,5-triazine-2,4-diyldiamine",91-76-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30070ff3-fb68-478e-a56c-503d83ea6c2b/documents/IUC5-5e26d2c0-a02a-44ee-b95d-78d723713c92_6467afaa-e03f-4820-90e4-c7559468dc23.html,,oral,LD50,933 mg/kg bw,adverse effect observed, "6-phenyl-1,3,5-triazine-2,4-diyldiamine",91-76-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30070ff3-fb68-478e-a56c-503d83ea6c2b/documents/IUC5-5e26d2c0-a02a-44ee-b95d-78d723713c92_6467afaa-e03f-4820-90e4-c7559468dc23.html,,inhalation,LC50,2.932 mg/m3,adverse effect observed, Benzoic acid,65-85-0,"Oral: The studies available on the analogue sodium benzoate are feeding studies in rat and mice (one drinking water study in mice). Mice seem to be less susceptible to the effects of the analogue than rats. Effects are severe decrease of body weight with effects in the liver. The no effect level is 2% in the diet of rats. In the reports available different conversion methods are used to calculate the actual test substance intake. This may have been done by actual measurement of food intake, but is not clearly described in the publications. Therefore a calculation was done based on the factors as described in the WHO report (EHS Environmental Health Criteria 240). This leads to a NOAEL of 1000 mg/kg bw based on the 2% dietary level in rats.In a chronic toxicity/carcinogenicity study in rats (Sodemoto, 1979) no signs of toxicity were reported at 2% of the analogue in feed (stated to be equivalent to 1000 mg/kg bw).Dermal: A study is available with a NOAEL of the key study of > 2500 mg/kg bw/day (Marroquin, 1981).Inhalation: A study is available with a NOAEL of the key study of 250 mg/m3 (Benson, 1981). These findings were primarily attributed to the physico-chemical properties of these fine low-solubility particles. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c3b0363-9226-443e-85cb-eed1821e2f2c/documents/595f9df7-d85b-4591-97bb-864e71895c54_5c5eb013-c945-437e-938f-45a9d2fbd84d.html,,,,,, Benzoic acid,65-85-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c3b0363-9226-443e-85cb-eed1821e2f2c/documents/595f9df7-d85b-4591-97bb-864e71895c54_5c5eb013-c945-437e-938f-45a9d2fbd84d.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,500 mg/kg bw/day",,rabbit Benzoic acid,65-85-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c3b0363-9226-443e-85cb-eed1821e2f2c/documents/595f9df7-d85b-4591-97bb-864e71895c54_5c5eb013-c945-437e-938f-45a9d2fbd84d.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,250 mg/m3,,rat Benzoic acid,65-85-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c3b0363-9226-443e-85cb-eed1821e2f2c/documents/595f9df7-d85b-4591-97bb-864e71895c54_5c5eb013-c945-437e-938f-45a9d2fbd84d.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Benzoic acid,65-85-0,Oral: Two studies are available with a LD50 of 2250 mg/kg bw in mice and 2565 mg/kg bw in ratsDermal: Multiple studies are available with a LD50 of the key study of >2000 mg/kg bw.Inhalation: A study is available with a LC50 of the key study of 12200 mg/m3 air.Other routes: A study is available with the LD50 of 1460 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c3b0363-9226-443e-85cb-eed1821e2f2c/documents/bddbe455-1180-46b6-9c16-2b94541fff9e_5c5eb013-c945-437e-938f-45a9d2fbd84d.html,,,,,, Benzoic acid,65-85-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c3b0363-9226-443e-85cb-eed1821e2f2c/documents/bddbe455-1180-46b6-9c16-2b94541fff9e_5c5eb013-c945-437e-938f-45a9d2fbd84d.html,,oral,LD50,"2,250 mg/kg bw",no adverse effect observed, Benzoic acid,65-85-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c3b0363-9226-443e-85cb-eed1821e2f2c/documents/bddbe455-1180-46b6-9c16-2b94541fff9e_5c5eb013-c945-437e-938f-45a9d2fbd84d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Benzoic acid,65-85-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c3b0363-9226-443e-85cb-eed1821e2f2c/documents/bddbe455-1180-46b6-9c16-2b94541fff9e_5c5eb013-c945-437e-938f-45a9d2fbd84d.html,,inhalation,LC50,"12,200 mg/m3",no adverse effect observed, Benzonitrile,100-47-0,Several sub-acute and sub-chronic studies (up to 90 days) are available for the oral and inhalation route. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d86a292-1609-409a-8e60-7341be5bf46a/documents/IUC5-10bef704-a0c1-4aa8-9ffe-7c810a3093d6_7e848114-9d71-4537-a8cb-96206e8a446f.html,,,,,, Benzonitrile,100-47-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d86a292-1609-409a-8e60-7341be5bf46a/documents/IUC5-10bef704-a0c1-4aa8-9ffe-7c810a3093d6_7e848114-9d71-4537-a8cb-96206e8a446f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,37.5 mg/kg bw/day,,rat Benzonitrile,100-47-0,Several acute toxicity studies are available for all routes. Overall with sufficient reliability. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d86a292-1609-409a-8e60-7341be5bf46a/documents/IUC5-322a5d2f-9b97-41f0-90aa-fdb9c26d6a0e_7e848114-9d71-4537-a8cb-96206e8a446f.html,,,,,, Benzonitrile,100-47-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d86a292-1609-409a-8e60-7341be5bf46a/documents/IUC5-322a5d2f-9b97-41f0-90aa-fdb9c26d6a0e_7e848114-9d71-4537-a8cb-96206e8a446f.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, Benzonitrile,100-47-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d86a292-1609-409a-8e60-7341be5bf46a/documents/IUC5-322a5d2f-9b97-41f0-90aa-fdb9c26d6a0e_7e848114-9d71-4537-a8cb-96206e8a446f.html,,dermal,LD50,"1,400 mg/kg bw",adverse effect observed, Benzonitrile,100-47-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d86a292-1609-409a-8e60-7341be5bf46a/documents/IUC5-322a5d2f-9b97-41f0-90aa-fdb9c26d6a0e_7e848114-9d71-4537-a8cb-96206e8a446f.html,,inhalation,LC50,"8,000 mg/m3",adverse effect observed, Benzophenone,119-61-9," Subchronic oral (diet) study in rats, 90 days: NO(A)EL 20 mg/kg bw (Burdock et al., 1991). From two other 14 week oral studies with dosing of F344/N rats and B6C3F1 mice with 0, 1250, 2500, 5000, 10000 or 20000 ppm continuously via diet no NO(A)EL values were derived due to effects even at the lowest dose. The LOAEL for rats and mice was given with 75-80 mg/kg bw and 200-270 mg/kg bw, resp. (NTP, 2000). For the dermal and inhalation route, there are no data available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69a5afee-5238-4ff7-ac31-d9af693cbb31/documents/IUC5-7c658860-f27a-404a-9f96-b531940fec5b_e05cf98e-5130-4e28-a662-c7b3fc163244.html,,,,,, Benzophenone,119-61-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69a5afee-5238-4ff7-ac31-d9af693cbb31/documents/IUC5-7c658860-f27a-404a-9f96-b531940fec5b_e05cf98e-5130-4e28-a662-c7b3fc163244.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat Benzophenone,119-61-9,"Acute toxicity, oral: mouse LD50 = ca. 2895 mg/kg bw; rat LD50: > 10000 mg/kg bw (Caprino et al., 1975; Opdyke, 1979)Acute toxicity, dermal: rabbit LD50: 3535 mg/kg bw (Opdyke, 1979) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69a5afee-5238-4ff7-ac31-d9af693cbb31/documents/IUC5-6e63db20-4542-4890-a1ae-e2e06496aff1_e05cf98e-5130-4e28-a662-c7b3fc163244.html,,,,,, Benzophenone,119-61-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69a5afee-5238-4ff7-ac31-d9af693cbb31/documents/IUC5-6e63db20-4542-4890-a1ae-e2e06496aff1_e05cf98e-5130-4e28-a662-c7b3fc163244.html,,oral,LD50,"2,895 mg/kg bw",adverse effect observed, Benzophenone,119-61-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69a5afee-5238-4ff7-ac31-d9af693cbb31/documents/IUC5-6e63db20-4542-4890-a1ae-e2e06496aff1_e05cf98e-5130-4e28-a662-c7b3fc163244.html,,dermal,LD50,"3,535 mg/kg bw",no adverse effect observed, "2,4-dihydroxybenzophenone",131-56-6,"Short-term repeated NOAEL (rat, male) = 300 mg/kg bw/day (OECD 422/GLP) Short-term repeated NOAEL (rat, female) = 1000 mg/kg bw/day (OECD 422/GLP) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1f18e4f0-a518-4cab-bb79-256962c1e936/documents/IUC5-6dcc366d-3e47-4029-a592-3e65f6ffc2de_e38f8d98-7565-4e63-acda-56d3c5bea5d8.html,,,,,, "2,4-dihydroxybenzophenone",131-56-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1f18e4f0-a518-4cab-bb79-256962c1e936/documents/IUC5-6dcc366d-3e47-4029-a592-3e65f6ffc2de_e38f8d98-7565-4e63-acda-56d3c5bea5d8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2,4-dihydroxybenzophenone",131-56-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f18e4f0-a518-4cab-bb79-256962c1e936/documents/IUC5-0d8052c3-8cad-48ed-86e6-6f7eb5516fe0_e38f8d98-7565-4e63-acda-56d3c5bea5d8.html,,oral,LD50,"8,600 mg/kg bw",adverse effect observed, Octabenzone,1843-05-6,"The test item caused adverse effects on kidneys upon subchronic feed application to rats with a NOAEL of 1500 ppm (ca 75 mg/kg bw). Upon gavage dosage, rats do not suffer from adverse findings at doses of up to 1000 mg/kg bw as shown in a GLP-compliant 28d study and in a GLP-compliant OECD 422 study. In dogs, liver was identified as target organ in a two year feeding study; the NOAEL was 3000 ppm (ca 100 mg/kg bw). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/843a3bca-5642-4df7-bd03-09a659afe2c1/documents/55ec045a-2673-47f9-8c4b-a36df3104032_5a81b72c-630c-40b8-a0aa-05724bfd1a88.html,,,,,, Octabenzone,1843-05-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/843a3bca-5642-4df7-bd03-09a659afe2c1/documents/55ec045a-2673-47f9-8c4b-a36df3104032_5a81b72c-630c-40b8-a0aa-05724bfd1a88.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat Octabenzone,1843-05-6,The test item did not cause mortality or signs of acute intoxication in male rats that received a single oral dose of 10000 mg/kg body weight or in male rabbits that received a single dermal dose of 10000 mg/kg body weight. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/843a3bca-5642-4df7-bd03-09a659afe2c1/documents/22b4b54f-20cf-41e8-8356-7805f2c502a9_5a81b72c-630c-40b8-a0aa-05724bfd1a88.html,,,,,, Octabenzone,1843-05-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/843a3bca-5642-4df7-bd03-09a659afe2c1/documents/22b4b54f-20cf-41e8-8356-7805f2c502a9_5a81b72c-630c-40b8-a0aa-05724bfd1a88.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, Octabenzone,1843-05-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/843a3bca-5642-4df7-bd03-09a659afe2c1/documents/22b4b54f-20cf-41e8-8356-7805f2c502a9_5a81b72c-630c-40b8-a0aa-05724bfd1a88.html,,dermal,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, Sulisobenzone,4065-45-6,"Repeated dose toxicity: Oral Based on the data available, the No Observed Adverse Effect Level (NOAEL) for the test chemical was considered to be 1250mg/Kg bw/day in male and female rats following oral gavage exposure for a period of 48 -66 days.   Repeated dose toxicity: inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the test chemical which is reported as mm Hg. Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely. Therefore this study is considered for waiver.   Repeated dose toxicity: dermal The acute toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c7a69b1-9e51-4e4a-9b30-8f6dac099ad3/documents/83d29919-a4a2-48f6-ab4d-efd8b993b8d4_7633af8b-c3ba-46cc-a20e-e97294c99ff4.html,,,,,, Sulisobenzone,4065-45-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c7a69b1-9e51-4e4a-9b30-8f6dac099ad3/documents/83d29919-a4a2-48f6-ab4d-efd8b993b8d4_7633af8b-c3ba-46cc-a20e-e97294c99ff4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,250 mg/kg bw/day",,rat Sulisobenzone,4065-45-6,"Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The LD50 value is 3530 mg/kg bw. The studies concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.   Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to low vapour pressure of the test chemical, which is reported to be 1.79E-009 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on study conducted on rabbits for the test chemical. The LD50 value is >5000 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c7a69b1-9e51-4e4a-9b30-8f6dac099ad3/documents/IUC5-11397434-630e-46e4-a62e-6d367b19602d_7633af8b-c3ba-46cc-a20e-e97294c99ff4.html,,,,,, Sulisobenzone,4065-45-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c7a69b1-9e51-4e4a-9b30-8f6dac099ad3/documents/IUC5-11397434-630e-46e4-a62e-6d367b19602d_7633af8b-c3ba-46cc-a20e-e97294c99ff4.html,,oral,LD50,"3,530 mg/kg bw",no adverse effect observed, Sulisobenzone,4065-45-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c7a69b1-9e51-4e4a-9b30-8f6dac099ad3/documents/IUC5-11397434-630e-46e4-a62e-6d367b19602d_7633af8b-c3ba-46cc-a20e-e97294c99ff4.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Benzothiazole,95-16-9,"oral, gavage, single dose, similar to OECD 401, LD50=257 mg/kg bw (m), LD50=177 mg/kg bw (f)  inhalation, 4 h, aerosol, according to OECD 403, GLP, LC50 (m/f)=5000 mg/m³ dermal, 24 h, occlusive, according to OECD 402, GLP, LD50=1231 mg/kg bw (m), LD50=933 mg/kg bw (f) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07a45611-7234-4f35-be15-fd9dce362358/documents/IUC5-19325436-7405-4147-a1fc-0c07ca7d7752_23a99de1-8a48-4bc8-86f1-c86566171240.html,,,,,, Benzothiazole,95-16-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07a45611-7234-4f35-be15-fd9dce362358/documents/IUC5-19325436-7405-4147-a1fc-0c07ca7d7752_23a99de1-8a48-4bc8-86f1-c86566171240.html,,oral,LD50,177 mg/kg bw,adverse effect observed, Benzothiazole,95-16-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07a45611-7234-4f35-be15-fd9dce362358/documents/IUC5-19325436-7405-4147-a1fc-0c07ca7d7752_23a99de1-8a48-4bc8-86f1-c86566171240.html,,dermal,LD50,933 mg/kg bw,adverse effect observed, Benzothiazole,95-16-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07a45611-7234-4f35-be15-fd9dce362358/documents/IUC5-19325436-7405-4147-a1fc-0c07ca7d7752_23a99de1-8a48-4bc8-86f1-c86566171240.html,,inhalation,LC50,"5,000 mg/m3",adverse effect observed, Benzotriazole,95-14-7,A LOAEL of 325 mg/kg bw/day is taken from a chronic carcinogenicity study. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83f4e63b-547b-4d28-8c91-99571444fe3c/documents/91500381-7ed4-4ee5-9ddb-2d52a092e957_10550544-7bfe-4ceb-8e83-5f73214f7711.html,,,,,, Benzotriazole,95-14-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83f4e63b-547b-4d28-8c91-99571444fe3c/documents/91500381-7ed4-4ee5-9ddb-2d52a092e957_10550544-7bfe-4ceb-8e83-5f73214f7711.html,Chronic toxicity – systemic effects,oral,LOAEL,325 mg/kg bw/day,,rat Benzotriazole,95-14-7,"The substance has an oral LD50 of 720 mg/kg bw. In an acute dermal toxicity test the limit dose of 2000 mg/kg bw did not lead to mortality, the dermal LD50 is set to 2000 mg/kg bw by default.A valid inhalative LC50 is not available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83f4e63b-547b-4d28-8c91-99571444fe3c/documents/f875aaa0-56da-4dd6-8d91-e382736ffd3b_10550544-7bfe-4ceb-8e83-5f73214f7711.html,,,,,, Benzotriazole,95-14-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83f4e63b-547b-4d28-8c91-99571444fe3c/documents/f875aaa0-56da-4dd6-8d91-e382736ffd3b_10550544-7bfe-4ceb-8e83-5f73214f7711.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Benzotriazole,95-14-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83f4e63b-547b-4d28-8c91-99571444fe3c/documents/f875aaa0-56da-4dd6-8d91-e382736ffd3b_10550544-7bfe-4ceb-8e83-5f73214f7711.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "A mixture of: isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-tetracosylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol. n=5 or 6",125304-04-3," In a subacute study with rats the test substance did not cause any adverse effects up to the highest dose tested (1000 mg/kg), therefore, the NOAEL was set at 1000 mg/kg bw. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5777dad-44e0-44c3-a9e4-1cd484519fec/documents/IUC5-1ac36cbf-56da-4d7b-8da8-570a0f1c6533_b8e82573-1a0b-486b-98da-8ee5d16af4bc.html,,,,,, "A mixture of: isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-tetracosylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol. n=5 or 6",125304-04-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5777dad-44e0-44c3-a9e4-1cd484519fec/documents/IUC5-1ac36cbf-56da-4d7b-8da8-570a0f1c6533_b8e82573-1a0b-486b-98da-8ee5d16af4bc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "A mixture of: isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-tetracosylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol. n=5 or 6",125304-04-3, - Acute oral toxicity (OECD guideline 401 & GLP): LD50 > 5000 mg/kg bw - Acute dermal toxicity (OECD guideline 402): LD50 > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5777dad-44e0-44c3-a9e4-1cd484519fec/documents/IUC5-3051fdb7-c66c-4152-b44c-9fa1d5126400_b8e82573-1a0b-486b-98da-8ee5d16af4bc.html,,,,,, "A mixture of: isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-tetracosylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol. n=5 or 6",125304-04-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5777dad-44e0-44c3-a9e4-1cd484519fec/documents/IUC5-3051fdb7-c66c-4152-b44c-9fa1d5126400_b8e82573-1a0b-486b-98da-8ee5d16af4bc.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "A mixture of: isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-dodecylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-(n)-tetracosylphenol; isomers of 2-(2H-benzotriazol-2-yl)-4-methyl-5,6-didodecyl-phenol. n=5 or 6",125304-04-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5777dad-44e0-44c3-a9e4-1cd484519fec/documents/IUC5-3051fdb7-c66c-4152-b44c-9fa1d5126400_b8e82573-1a0b-486b-98da-8ee5d16af4bc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-hydroxy-2-methylpropiophenone,7473-98-5, OECD 408 study (Repeated Dose Oral Toxicity 90 days study) conducted to recognised training guidelines with CLP certification. Repeated dose toxicity study (28 days) conducted to generally recognised scientific standards. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6210e24-5a3b-4dd6-a61c-5231c0b295c1/documents/e2ebdf2f-5677-43e9-ad71-e7c919ee3c0f_caff12db-894e-49af-9169-d791553c5e4b.html,,,,,, 2-hydroxy-2-methylpropiophenone,7473-98-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6210e24-5a3b-4dd6-a61c-5231c0b295c1/documents/e2ebdf2f-5677-43e9-ad71-e7c919ee3c0f_caff12db-894e-49af-9169-d791553c5e4b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 2-hydroxy-2-methylpropiophenone,7473-98-5,A single dose of the test item was administered by gavage at concentrations up to 3200 mg/kg bw and topically at concentrations up to 10000 mg/kg bw. Mortality occurred at concentrations from 1400 mg/kg bw (orally) or 5000 mg/kg bw (dermally) onward. Signs of toxicity as wells as effects on liver and urinary bladder were recorded in deceased animals. Scheduled sacrificed animals in both studies did not show any adverse findings. The LD50 after oral administration is therefore considered to be 1694 mg/kg bw and after dermal application 6929 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6210e24-5a3b-4dd6-a61c-5231c0b295c1/documents/2d6daa3d-0b8f-491d-b300-10725d97ee5e_caff12db-894e-49af-9169-d791553c5e4b.html,,,,,, 2-hydroxy-2-methylpropiophenone,7473-98-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6210e24-5a3b-4dd6-a61c-5231c0b295c1/documents/2d6daa3d-0b8f-491d-b300-10725d97ee5e_caff12db-894e-49af-9169-d791553c5e4b.html,,oral,LD50,"1,694 mg/kg bw",adverse effect observed, 2-hydroxy-2-methylpropiophenone,7473-98-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6210e24-5a3b-4dd6-a61c-5231c0b295c1/documents/2d6daa3d-0b8f-491d-b300-10725d97ee5e_caff12db-894e-49af-9169-d791553c5e4b.html,,dermal,LD50,"6,929 mg/kg bw",no adverse effect observed, Dibenzoyl peroxide,94-36-0,"Subacute and/or chronic toxicity studies are available for both the oral and dermal routes of administration. Considering the limited toxicological effects reported in subacute (Park, 2002; Jia et al., 2011), subchronic (Anke van Erp, 2023) and chronic (Sharratt et al., 1964) toxicity studies and also for the BPO metabolite, benzoic acid (IPCS, 2000) , the NOAEL of ca. 200 mg/kg bw/day in rats derived from the 120 weeks dietary administration of benzoyl peroxide in rats can be considered as a conservative NOAEL. There were no findings indicative of systemic toxicity resulting from daily topical exposure of rats and mice to benzoyl peroxide gels at dose level of 100 and 833 mg/kg bw/d for 104 consecutive weeks, respectively. Skin irritation was observed at a dose level as low as 0.3 mg/cm²/day (1.67%) in rats but not at 0.17 mg/cm² (1%) in mice (CHPA, 2000, 2001).  As the chronic study in rat did not allow to derive a NOAEL for the local irritation, the NOAEL issued from the mouse study is used for risk assessment. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc64c6cd-9509-42ff-9b8d-03c8067bbb49/documents/IUC5-ee0233de-911d-4da8-baea-14d5aac01abb_bf5f1d51-3909-48b9-9a93-882a1da306eb.html,,,,,, Dibenzoyl peroxide,94-36-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc64c6cd-9509-42ff-9b8d-03c8067bbb49/documents/IUC5-ee0233de-911d-4da8-baea-14d5aac01abb_bf5f1d51-3909-48b9-9a93-882a1da306eb.html,Chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Dibenzoyl peroxide,94-36-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc64c6cd-9509-42ff-9b8d-03c8067bbb49/documents/IUC5-ee0233de-911d-4da8-baea-14d5aac01abb_bf5f1d51-3909-48b9-9a93-882a1da306eb.html,Chronic toxicity – systemic effects,dermal,NOAEL,833 mg/kg bw/day,,rat Dibenzoyl peroxide,94-36-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc64c6cd-9509-42ff-9b8d-03c8067bbb49/documents/IUC5-ee0233de-911d-4da8-baea-14d5aac01abb_bf5f1d51-3909-48b9-9a93-882a1da306eb.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.17 mg/cm2,adverse effect observed,mouse Dibenzoyl peroxide,94-36-0,"The acute oral toxicity of benzoyl peroxide is low: LD50 in mice >2,000 mg/kg, and in rats 5,000 mg/kg. No deaths occurred in male rats following inhalation of 24.3 mg/l. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc64c6cd-9509-42ff-9b8d-03c8067bbb49/documents/IUC5-2650724e-f6b9-43b1-abc8-4ff08cb69d54_bf5f1d51-3909-48b9-9a93-882a1da306eb.html,,,,,, Dibenzoyl peroxide,94-36-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc64c6cd-9509-42ff-9b8d-03c8067bbb49/documents/IUC5-2650724e-f6b9-43b1-abc8-4ff08cb69d54_bf5f1d51-3909-48b9-9a93-882a1da306eb.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Dibenzoyl peroxide,94-36-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc64c6cd-9509-42ff-9b8d-03c8067bbb49/documents/IUC5-2650724e-f6b9-43b1-abc8-4ff08cb69d54_bf5f1d51-3909-48b9-9a93-882a1da306eb.html,,inhalation,discriminating conc.,"24,300 mg/m3",no adverse effect observed, Benzyl acetate,140-11-4, Five oral repeated dose toxicity studies are available. The studies were conducted using rats and mice as the test species. The studies were conducted for a period of 14 days or 13 weeks. There is no indication that the studies conformed to guidelines or were GLP compliant. The NOAEL derived for subchronic exposure to rats was 250 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e5b3a39-9274-475c-ae75-c7d7a4c7df8d/documents/IUC5-0c16c4c0-48ad-4e2c-a007-e885fff1599c_75ef12c9-0189-4780-a4f4-fd2479918c2c.html,,,,,, Benzyl acetate,140-11-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e5b3a39-9274-475c-ae75-c7d7a4c7df8d/documents/IUC5-0c16c4c0-48ad-4e2c-a007-e885fff1599c_75ef12c9-0189-4780-a4f4-fd2479918c2c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Benzyl acetate,140-11-4," Several studies are available for Acute oral, dermal and inhalation toxicity. The studies were conducted using rats, mice and rabbits as the test species. Two of the Acute Oral Toxicity studies conformed to OECD Guideline 401. The Acute Inhalation Toxicity Study conformed to OECD Guideline 403. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e5b3a39-9274-475c-ae75-c7d7a4c7df8d/documents/IUC5-f1fdde60-fd85-4586-9aa6-7b8a1bff2b2c_75ef12c9-0189-4780-a4f4-fd2479918c2c.html,,,,,, Benzyl acetate,140-11-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e5b3a39-9274-475c-ae75-c7d7a4c7df8d/documents/IUC5-f1fdde60-fd85-4586-9aa6-7b8a1bff2b2c_75ef12c9-0189-4780-a4f4-fd2479918c2c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Benzyl acetate,140-11-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e5b3a39-9274-475c-ae75-c7d7a4c7df8d/documents/IUC5-f1fdde60-fd85-4586-9aa6-7b8a1bff2b2c_75ef12c9-0189-4780-a4f4-fd2479918c2c.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Benzyl acetate,140-11-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e5b3a39-9274-475c-ae75-c7d7a4c7df8d/documents/IUC5-f1fdde60-fd85-4586-9aa6-7b8a1bff2b2c_75ef12c9-0189-4780-a4f4-fd2479918c2c.html,,inhalation,LC50,766 mg/m3,no adverse effect observed, 4-phenylbutan-2-one,2550-26-7,NOAEL (oral) = 500 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54178a3d-0b2a-4dd5-8479-7449be47b366/documents/IUC5-ac61957c-1f93-40a7-940b-87bfdb48d03d_efda4752-de5c-44cd-bbaa-a0e41d207206.html,,,,,, 4-phenylbutan-2-one,2550-26-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54178a3d-0b2a-4dd5-8479-7449be47b366/documents/IUC5-ac61957c-1f93-40a7-940b-87bfdb48d03d_efda4752-de5c-44cd-bbaa-a0e41d207206.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat 4-phenylbutan-2-one,2550-26-7,Oral: LD50 = 3200 mg/kg body weight leading to no classification according to CLPDermal: LD50 > 5000 mg/kg body weight leading to no classification according to CLPInhalation: no information available ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54178a3d-0b2a-4dd5-8479-7449be47b366/documents/IUC5-e9b7576d-4ccd-4b53-9e15-c726a872b98d_efda4752-de5c-44cd-bbaa-a0e41d207206.html,,,,,, Benzyl alcohol,100-51-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): No effect observed even at the highest dose concentration tested. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): No effect observed even at the highest dose concentration tested. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2db735b0-abeb-4b59-88b0-15994088e929/documents/IUC5-18749935-ae53-4bc8-a25b-801335eb3baf_738a36d4-63e2-4ab1-89cd-df5789884564.html,,,,,, Benzyl alcohol,100-51-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2db735b0-abeb-4b59-88b0-15994088e929/documents/IUC5-18749935-ae53-4bc8-a25b-801335eb3baf_738a36d4-63e2-4ab1-89cd-df5789884564.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,072 mg/m3",,rat Benzyl alcohol,100-51-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2db735b0-abeb-4b59-88b0-15994088e929/documents/IUC5-18749935-ae53-4bc8-a25b-801335eb3baf_738a36d4-63e2-4ab1-89cd-df5789884564.html,Chronic toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat Benzyl alcohol,100-51-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2db735b0-abeb-4b59-88b0-15994088e929/documents/IUC5-18749935-ae53-4bc8-a25b-801335eb3baf_738a36d4-63e2-4ab1-89cd-df5789884564.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,072 mg/m3",adverse effect observed,rat Benzyl alcohol,100-51-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2db735b0-abeb-4b59-88b0-15994088e929/documents/IUC5-6323baca-fe37-48e1-ac5a-fb9fef51dec5_738a36d4-63e2-4ab1-89cd-df5789884564.html,,oral,LD50,"1,620 mg/kg bw",adverse effect observed, Benzyl alcohol,100-51-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2db735b0-abeb-4b59-88b0-15994088e929/documents/IUC5-6323baca-fe37-48e1-ac5a-fb9fef51dec5_738a36d4-63e2-4ab1-89cd-df5789884564.html,,inhalation,discriminating conc.,"4,178 mg/m3",no adverse effect observed, Benzyl benzoate,120-51-4,"The oral toxicity of benzyl benzoate was determined in a repeated exposure study primarily investigating cytostatic activity but there were no indications of adverse systemic effects up to the cytostatically effective dose level of 800 mg/kg bw/d.In a subacute dermal toxicity study the lowest effective dose level was 1250 mg/kg bw/d. Mortalities occurred at 2000 mg/kg bw/d but no adverse systemic toxicity was noted at 1250 mg/kg bw/d or lower dose levels. No local dermal effects were identified. Benzyl benzoate was shown to be hydrolysed relatively rapidly in human plasma in vitro; a half-life of 19 minutes was shown. Benzyl benzoate hydrolyses to benzoic acid (65-85-0) and the corresponding alcohol (benzyl alcohol, CAS 100-51-6). This hydrolysis rate indicates rapid metabolism in vivo and suggests that bioaccumulation of benzyl benzoate is unlikely.(Nielsen NM & Bundgaard H, Prodrugs as delivery systems, 68. Chemical and plasma-catalyzed hydrolysis of various esters of benzoic acid: a reference system for designing prodrug esters of carboxylic acid agents, International Journal of Pharmaceutics 39: 75-85 (1987).http://www.inchem.org/documents/jecfa/jecmono/v48je14.htmBased on the fast hydrolysis to benzoic acid and benzyl alcohol the systemic effects of these two substances are considered after absorption of benzyl benzoate.   In a 13 week study male and female rats received once daily on 5 days/week 0, 50, 100, 200, 400, 800 mg/kg bw benzyl alcohol via gavage. Based on clinical signs and reduced body weight development in males and females and histopathological changes in the brain at 800 mg/kg bw the NOAEL was considered to be 400 mg/kg bw/day (NTP TR 343, 1989).   Benzoic acid (BA) was administered in the diet to male and female Sprague Dawley Crl:CD(SD) rats in an OECD Test Guideline 443 Extended One-Generation Reproductive Toxicity (EOGRT) study to test for effects that may occur as a result of pre- and postnatal exposure. The study included cohorts of F1 offspring to evaluate potential effects of benzoic acid on reproduction, the developing immune system, and the developing neurological system with the inclusion of learning and memory assessments. Benzoic acid was incorporated in the diet at concentrations of 0, 7,500, 11,500, and 15,000 mg/kg diet (ppm). These concentrations were selected based on the results of preliminary studies, and, based on average food consumption, were intended to supply BA doses of approximately 0, 500, 750, and 1000 mg/kg bw/day. To avoid exceeding these target dose levels, the dietaryThe highest dietary concentration (15,000 ppm), providing a dosage of approximately 1000 mg/kg bw/day, was the NOAEL for benzoic acid in this EOGRT study.   The NOAEL of 400 mg/kg bw/day from the 13 week study with benzyl alcohol is used for the derivation of the systemic DNELs. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): One 30-day range-finding rat study and one non-standard 90-day rabbit are available Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): One 30-day range-finding rat study and one non-standard 90-day rabbit are available Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Non-standard assessment of toxicity ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31bd28e6-fa3e-42a9-9b09-e5afb98765d5/documents/IUC5-baaa728d-39bd-4f13-a8f2-000a94d00664_1ab9f9bc-3c18-42e8-b6ac-b1f9cb3cfe1d.html,,,,,, Benzyl benzoate,120-51-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31bd28e6-fa3e-42a9-9b09-e5afb98765d5/documents/IUC5-baaa728d-39bd-4f13-a8f2-000a94d00664_1ab9f9bc-3c18-42e8-b6ac-b1f9cb3cfe1d.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,781 mg/kg bw/day,,rat Benzyl benzoate,120-51-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31bd28e6-fa3e-42a9-9b09-e5afb98765d5/documents/IUC5-baaa728d-39bd-4f13-a8f2-000a94d00664_1ab9f9bc-3c18-42e8-b6ac-b1f9cb3cfe1d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat Benzyl benzoate,120-51-4,"Acute oral toxicity studies are available in the rat and mouse; an early acute dermal toxicity study is also available in the rat. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable rat study supported by data in the mouse Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Non-standard screening study in the rabbit ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31bd28e6-fa3e-42a9-9b09-e5afb98765d5/documents/IUC5-df265119-4e3e-42a7-852a-8dcb1897faf8_1ab9f9bc-3c18-42e8-b6ac-b1f9cb3cfe1d.html,,,,,, Benzyl benzoate,120-51-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31bd28e6-fa3e-42a9-9b09-e5afb98765d5/documents/IUC5-df265119-4e3e-42a7-852a-8dcb1897faf8_1ab9f9bc-3c18-42e8-b6ac-b1f9cb3cfe1d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Benzyl butyrate,103-37-7," Repeated Dose Oral Toxicity Repeated dose oral toxicity study was performed using rats to determine the toxic nature of the test chemical. The test chemical was incorporated into the diet of 24 (12/sex) rats for 12 weeks as part of a blend with five other aromatic esters. The total intake was 2229.9 (males) and 1815.9 mg (females); The test chemical alone was not measured. Observations were made on physical appearance, behavior, and food utilization.  Urine samples were collected at the end of the 12 weeks. Liver and kidney weights were obtained. The no observed adverse effect level (NOAEL) is considered to be 2229.9 mg/Kg (males) and 1815.9 mg/Kg (females) when rats were exposed to the test chemical for 12 weeks. Repeated dose inhalation toxicity A short-term toxicity study need not be conducted because exposure of humans via inhalation route in production/use is highly unlikely based on the provided thorough and rigorous risk assessment. The test chemical has very low vapour pressure (6.5061 Pa.= 0.0487997562 mmHg),So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the short term inhalation toxicity end point was considered for waiver. Repeated dose dermal toxicity A short-term toxicity study need not be conducted because exposure of humans via dermal route in production/use is highly unlikely based on the provided thorough and rigorous risk assessment. he acute dermal toxicity value for Benzyl butyrate (CAS no 103-37-7) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver     ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ff53935-4d0a-41ba-90ab-75537b22db98/documents/2c9d09c0-c13c-4327-a01e-347179e1ee4d_d9bdbcb5-ba09-456a-9c53-5276228cd3b0.html,,,,,, Benzyl butyrate,103-37-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ff53935-4d0a-41ba-90ab-75537b22db98/documents/2c9d09c0-c13c-4327-a01e-347179e1ee4d_d9bdbcb5-ba09-456a-9c53-5276228cd3b0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,220 mg/kg bw/day",,rat Benzyl butyrate,103-37-7," Acute toxicity: Oral The reported study was designed and conducted to determine the acute oral toxicity profile of the given test chemical. Acute oral toxicity study was performed in groups of 10 young adult Osborne-Mendel rats evenly divided by sex using test chemical at dose concentration of 2330 mg/kg bw. 50% mortality was observed at dose 2330 mg/kg bw.Clinical signs like somnolence (general depressed activity), Scrawny appearance, tremors at higher doses were observed. Hence, LD50 value was considered to be 2330 mg/kg bw (1940-2800) with 95% confidence limits, when rats were treated with test chemical orally. Acute toxicity: Inhalation The study doesnot need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.Test chemical has very low vapour pressure (6.5061 Pa.= 0.0487997562 mmHg),So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver Acute toxicity: Dermal The reported study was designed and conducted to determine the acute dermal toxicity profile of the given test chemical. In acute dermal toxicity study, five rabbits were treated with test chemical in the concentration of 5000 mg/kg bw by dermal application followed by a 14 days observation period. No mortality was observed in treated rabbits at dose 5000 mg/kg bw. Necropsy was not conducted. Therefore, LD50 value was considered to be >5000 mg/kg bw,when rabbits were treated with test chemical by dermal application.  ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ff53935-4d0a-41ba-90ab-75537b22db98/documents/b7f2200d-6d1a-49e5-804d-ae39e31e3ba5_d9bdbcb5-ba09-456a-9c53-5276228cd3b0.html,,,,,, Benzyl butyrate,103-37-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ff53935-4d0a-41ba-90ab-75537b22db98/documents/b7f2200d-6d1a-49e5-804d-ae39e31e3ba5_d9bdbcb5-ba09-456a-9c53-5276228cd3b0.html,,oral,LD50,"2,330 mg/kg bw",no adverse effect observed, Benzyl butyrate,103-37-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ff53935-4d0a-41ba-90ab-75537b22db98/documents/b7f2200d-6d1a-49e5-804d-ae39e31e3ba5_d9bdbcb5-ba09-456a-9c53-5276228cd3b0.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Benzyl cinnamate,103-41-3, The substance is not toxic after oral repeated dosing. Rat: Oral (OECD 422): NOAEL = 600 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db918f86-97ab-42af-89b8-5d36442f8780/documents/01ea8866-26f8-4c8b-b07e-c8dfb8a01fd5_43789e05-7e92-470d-ad55-ef4e47631271.html,,,,,, Benzyl cinnamate,103-41-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db918f86-97ab-42af-89b8-5d36442f8780/documents/01ea8866-26f8-4c8b-b07e-c8dfb8a01fd5_43789e05-7e92-470d-ad55-ef4e47631271.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat Benzyl cinnamate,103-41-3,The substance is not acute toxic. For oral acute toxicity the LD50 was determined to be 3280 mg/kg bw and for dermal acute toxicity the LD50 > 3000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db918f86-97ab-42af-89b8-5d36442f8780/documents/88d06449-9073-4779-bfd2-5f508b712771_43789e05-7e92-470d-ad55-ef4e47631271.html,,,,,, Benzyl cinnamate,103-41-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db918f86-97ab-42af-89b8-5d36442f8780/documents/88d06449-9073-4779-bfd2-5f508b712771_43789e05-7e92-470d-ad55-ef4e47631271.html,,oral,LD50,"3,280 mg/kg bw",adverse effect observed, Benzyl formate,104-57-4, Oral: The LD50 value of the test substance was found to be 1000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f542f240-b5ca-465b-ae85-d192499c8f73/documents/IUC5-459a0b3d-388a-454b-a89a-080b0b5adca4_28a959ea-51a1-4afa-b60e-8f6d5db5223a.html,,,,,, Benzyl formate,104-57-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f542f240-b5ca-465b-ae85-d192499c8f73/documents/IUC5-459a0b3d-388a-454b-a89a-080b0b5adca4_28a959ea-51a1-4afa-b60e-8f6d5db5223a.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, 2-benzyloxyethanol,622-08-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1894c3ef-b5df-415f-9302-e2da0fb22c56/documents/d5fbb440-59c8-4225-9e63-92ae3faefbb9_b4ad6f89-015c-4e95-bcd4-e946a506698a.html,,oral,LD50,"1,190 ",adverse effect observed, Benzyl isobutyrate,103-28-6," Repeated dose toxicity oral: The No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day when rats were exposed to the test chemical orally. Repeated dose toxicity: Inhalation The repeated dose inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0412 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value for benzyl isobutyrate (CAS no 103-28-6) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bed2cd8-d427-45cb-8abd-beb7528f2802/documents/e1682544-b77b-4d55-b1ac-88887546350d_66140f63-6948-47d2-a580-3d4b92114ef8.html,,,,,, Benzyl isobutyrate,103-28-6,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bed2cd8-d427-45cb-8abd-beb7528f2802/documents/e1682544-b77b-4d55-b1ac-88887546350d_66140f63-6948-47d2-a580-3d4b92114ef8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Benzyl isobutyrate,103-28-6," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mouse for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.   Acute Inhalation Toxicity: Test chemical has very low vapour pressure (0.0428 mm Hg = 5.7 Pa),So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver.   Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bed2cd8-d427-45cb-8abd-beb7528f2802/documents/54a073c9-7c0d-4a85-ab54-bdd53e910711_66140f63-6948-47d2-a580-3d4b92114ef8.html,,,,,, Benzyl isobutyrate,103-28-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bed2cd8-d427-45cb-8abd-beb7528f2802/documents/54a073c9-7c0d-4a85-ab54-bdd53e910711_66140f63-6948-47d2-a580-3d4b92114ef8.html,,oral,LD50,"2,850 mg/kg bw",no adverse effect observed, Benzyl isobutyrate,103-28-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bed2cd8-d427-45cb-8abd-beb7528f2802/documents/54a073c9-7c0d-4a85-ab54-bdd53e910711_66140f63-6948-47d2-a580-3d4b92114ef8.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Benzyl isovalerate,103-38-8," Repeated dose toxicity oral: The No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day when rats were exposed to the test chemical orally. Repeated dose toxicity: Inhalation The repeated dose inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0355 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study for repeated dose toxicity by inhalation route of exposure is considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value forbenzyl isovalerate (CAS no 103-38-8)(as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d709b11-ee4e-4bd8-bae6-5e3266f1a289/documents/aa2a0f2b-cfae-4eda-a1cb-ca7b19cc0df9_e0a6a741-5fb2-4471-92c2-bdafdd01d0d0.html,,,,,, Benzyl isovalerate,103-38-8,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d709b11-ee4e-4bd8-bae6-5e3266f1a289/documents/aa2a0f2b-cfae-4eda-a1cb-ca7b19cc0df9_e0a6a741-5fb2-4471-92c2-bdafdd01d0d0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Benzyl isovalerate,103-38-8," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: Test chemical has very low vapour pressure (4.74 Pa.= 0.0355 mmHg),So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver. Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d709b11-ee4e-4bd8-bae6-5e3266f1a289/documents/4fba58d5-6739-494d-b370-7c6c14e3d647_e0a6a741-5fb2-4471-92c2-bdafdd01d0d0.html,,,,,, Benzyl isovalerate,103-38-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d709b11-ee4e-4bd8-bae6-5e3266f1a289/documents/4fba58d5-6739-494d-b370-7c6c14e3d647_e0a6a741-5fb2-4471-92c2-bdafdd01d0d0.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Benzyl isovalerate,103-38-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d709b11-ee4e-4bd8-bae6-5e3266f1a289/documents/4fba58d5-6739-494d-b370-7c6c14e3d647_e0a6a741-5fb2-4471-92c2-bdafdd01d0d0.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Benzyl phenylacetate,102-16-9, Acute oral toxicity: LD50 was considered to be > 5000 mg/kg bw when rat were treated with benzyl phenylacetate orally. Acute dermal toxicity: LD50 was considered to be > 10950 mg/kg bw when rabbits were treated with benzyl phenylacetate dermally. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c77833c-6aa5-40fd-8716-5527b9562174/documents/2540cabc-e28d-4057-8947-58e8dfe07323_10352f50-af0b-4df9-93cf-789e6beead8d.html,,,,,, Benzyl phenylacetate,102-16-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c77833c-6aa5-40fd-8716-5527b9562174/documents/2540cabc-e28d-4057-8947-58e8dfe07323_10352f50-af0b-4df9-93cf-789e6beead8d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Benzyl phenylacetate,102-16-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c77833c-6aa5-40fd-8716-5527b9562174/documents/2540cabc-e28d-4057-8947-58e8dfe07323_10352f50-af0b-4df9-93cf-789e6beead8d.html,,dermal,LD50,"10,950 mg/kg bw",no adverse effect observed, Benzyl propionate,122-63-4, The NOAEL for systemic toxicity was determined to be 500 mg/kg bw/day in an OECD 422 Guideline study. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f83b03a1-1a0d-4362-89cd-0dee521024c1/documents/dcfdb0d2-d1ea-4923-ae4c-4553971c3c18_905619b9-d29e-4af9-af29-680cc973c173.html,,,,,, Benzyl propionate,122-63-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f83b03a1-1a0d-4362-89cd-0dee521024c1/documents/dcfdb0d2-d1ea-4923-ae4c-4553971c3c18_905619b9-d29e-4af9-af29-680cc973c173.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Benzyl propionate,122-63-4, In an acute oral toxicity study the LD50 was determined to be 3300 mg/kg bw. The LD50 value for acute dermal toxicity was determined to be greater than 5000 mg/kg bw in rabbits. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f83b03a1-1a0d-4362-89cd-0dee521024c1/documents/ac0ff789-b0ec-4117-811d-76495c763459_905619b9-d29e-4af9-af29-680cc973c173.html,,,,,, Benzyl propionate,122-63-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f83b03a1-1a0d-4362-89cd-0dee521024c1/documents/ac0ff789-b0ec-4117-811d-76495c763459_905619b9-d29e-4af9-af29-680cc973c173.html,,oral,LD50,"3,300 mg/kg bw",adverse effect observed, Benzyl propionate,122-63-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f83b03a1-1a0d-4362-89cd-0dee521024c1/documents/ac0ff789-b0ec-4117-811d-76495c763459_905619b9-d29e-4af9-af29-680cc973c173.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Benzyl salicylate,118-58-1," The objective of this study was to evaluate the potential toxicity of Benzyl Salicylate when administered via the diet to Sprague Dawley rats for at least 90 consecutive days. The study design was as follows:  Group Number  Treatment  Dietary Concentrationa (ppm)*  Equivalent dose in mg/kg bw/d(males and females respectively) Number of animals/sex/group  1  Basal Diet  0  0  10  2  Benzyl Salicylate  1500   86 - 106  10  3  Benzyl Salicylate  3000  177 - 204  10  4  Benzyl Salicylate  6000  357 - 429  10 *Test substance was presented as a fixed dietary admix concentration without adjustment for body weight. There was no adjustment for purity when preparing the test or control diets. Animals were administered the test substance continuously in the diet for at least 90 consecutive days. The following parameters and end points were evaluated in this study: clinical signs, body weights, body weight gains, food consumption, ophthalmology, clinical pathology parameters (hematology, coagulation, serum chemistry, and urinalysis), thyroid hormone concentration (T3, T4, and TSH), gross necropsy findings, organ weights, and histopathologic examinations. Average compound consumption for the 1500, 3000, and 6000 ppm groups was 86, 177, and 357 mg/kg/day for males and 106, 204, and 429 mg/kg/day for females, respectively. All animals survived to the scheduled necropsy. There were no direct test substance-related clinical, ophthalmic, macroscopic, or microscopic observations or effects on serum chemistry, hematology, coagulation, urinalysis, thyroid hormone concentration, and organ weights. Adverse test substance-related lower body weights and body weight gains were noted in the 6000 ppm group males and females generally throughout the dosing period. In the 6000 ppm group males, lower food consumption was noted during the first week of dosing and lower food efficiency was noted throughout the first month of the dosing period. Lower mean food efficiency was also noted for females in the 6000 ppm group during 7 of the 13 weekly intervals during the study. Effects on mean food efficiency were considered adverse as they were a contributing factor to the adverse effects on body weights in males and females at 6000 ppm. Based on the results of this study, dietary administration of benzyl salicylate to Crl:CD(SD) rats at concentrations of 1500, 3000, and 6000 ppm for a minimum of 90 days resulted in adverse lower body weights, lower body weight gains, and decreased food efficiency for males and females at 6000 ppm. Therefore, the no-observed-effect level (NOEL) was considered to be 3000 ppm (equivalent to 177 and 204 mg/kg/day for males and females, respectively). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0208dde-f154-44f2-a3a5-f85b3ff5b545/documents/IUC5-426664b6-7c5b-4c6e-8167-2088f40e0c7a_e82feb3f-10d2-40a3-aed6-b69c29df3329.html,,,,,, Benzyl salicylate,118-58-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0208dde-f154-44f2-a3a5-f85b3ff5b545/documents/IUC5-426664b6-7c5b-4c6e-8167-2088f40e0c7a_e82feb3f-10d2-40a3-aed6-b69c29df3329.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,177 mg/kg bw/day,,rat Benzyl salicylate,118-58-1,"Acute oral toxicity: LD50 >3,000mg/kg in rat for both males and femalesAcute inhalation waivedAcute dermal toxicity: LD50>2000mg/kg in rat ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0208dde-f154-44f2-a3a5-f85b3ff5b545/documents/IUC5-36f3d28e-07a5-4fbb-9454-c5746f0f74cc_e82feb3f-10d2-40a3-aed6-b69c29df3329.html,,,,,, Benzyl salicylate,118-58-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0208dde-f154-44f2-a3a5-f85b3ff5b545/documents/IUC5-36f3d28e-07a5-4fbb-9454-c5746f0f74cc_e82feb3f-10d2-40a3-aed6-b69c29df3329.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, Benzyl salicylate,118-58-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0208dde-f154-44f2-a3a5-f85b3ff5b545/documents/IUC5-36f3d28e-07a5-4fbb-9454-c5746f0f74cc_e82feb3f-10d2-40a3-aed6-b69c29df3329.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-benzyloxane,60466-73-1," Oral LD50 > 2000 mg/kg bw (OECD 423, K, Rel.1, class method in rats) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37233bf7-11be-43d7-aa8d-d799dfcd33ea/documents/4e831d38-b818-4b79-a19c-47d6b490d4c4_5c70c18c-48df-4168-adea-e524448730d7.html,,,,,, 3-benzyloxane,60466-73-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37233bf7-11be-43d7-aa8d-d799dfcd33ea/documents/4e831d38-b818-4b79-a19c-47d6b490d4c4_5c70c18c-48df-4168-adea-e524448730d7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Benzyl 4-hydroxybenzoate,94-18-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Data is from peer reviewed journal Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Data is from peer reviewed journal ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b36d7b1-69f3-4356-b22a-76a696f6c3ce/documents/IUC5-e1122485-8b37-40dc-b481-ed985f8cfe81_25ba629c-ae09-4330-bb74-5d867f43734f.html,,,,,, Benzyl 4-hydroxybenzoate,94-18-8,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b36d7b1-69f3-4356-b22a-76a696f6c3ce/documents/IUC5-e1122485-8b37-40dc-b481-ed985f8cfe81_25ba629c-ae09-4330-bb74-5d867f43734f.html,Sub-chronic toxicity – systemic effects,oral,,0.16 mg/kg bw/day,,rat Benzyl 4-hydroxybenzoate,94-18-8,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b36d7b1-69f3-4356-b22a-76a696f6c3ce/documents/IUC5-e1122485-8b37-40dc-b481-ed985f8cfe81_25ba629c-ae09-4330-bb74-5d867f43734f.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,33 mg/kg bw/day,,mouse Benzyl 4-hydroxybenzoate,94-18-8,"Acute Oral  toxicity studies were carried out to estimate the toxicity of TridecanolIn the acute oral study conducted in Carworth - Wistar rats, the acute oral LD50 (with± 1.96 standard deviations) for tridecyl alcohol was found to be 2290.4 mg/kg (17.2ml/kg) ( range 16383.6 - 31834.8 mg/kg (12.3 – 23.9ml/kg)). ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b36d7b1-69f3-4356-b22a-76a696f6c3ce/documents/IUC5-15b34161-50b7-410d-8be8-520976c24fc8_25ba629c-ae09-4330-bb74-5d867f43734f.html,,,,,, Benzyl 4-hydroxybenzoate,94-18-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b36d7b1-69f3-4356-b22a-76a696f6c3ce/documents/IUC5-15b34161-50b7-410d-8be8-520976c24fc8_25ba629c-ae09-4330-bb74-5d867f43734f.html,,oral,LD50,"2,290.4 mg/kg bw",no adverse effect observed, "β,4-dimethylcyclohex-3-ene-1-propan-1-al",6784-13-0,Acute oral toxicity: LD50 is >2000 mg/kg bw in an OECD TG 423 ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e277792-2c48-49ad-8249-6b3ebb97ef07/documents/012968e7-ebd7-4c03-bc87-b83479e4ebdc_8839047a-14a5-4a72-8314-81a56dcc794e.html,,,,,, "β,4-dimethylcyclohex-3-ene-1-propan-1-al",6784-13-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e277792-2c48-49ad-8249-6b3ebb97ef07/documents/012968e7-ebd7-4c03-bc87-b83479e4ebdc_8839047a-14a5-4a72-8314-81a56dcc794e.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, β-alanine,107-95-9,"-Repeated dose toxicity: oral (GLP, OECD TG 407), NOAEL=1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9c7c040-3611-4c4a-9ed9-28bd25b33625/documents/IUC5-e06a9798-3326-461b-9336-fd5382630beb_6fcfd8c5-61b0-4014-953f-eb4531e4c129.html,,,,,, β-alanine,107-95-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9c7c040-3611-4c4a-9ed9-28bd25b33625/documents/IUC5-e06a9798-3326-461b-9336-fd5382630beb_6fcfd8c5-61b0-4014-953f-eb4531e4c129.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, β-alanine,107-95-9,"- Acute toxicity: -oral: LD50 >5000 mg/kg bw (limit test, Guidelines for Toxicity Studies of Drugs (Japan) , GLP conditions, fixed dose procedure); -inhalation: waiver; -dermal: waiver. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9c7c040-3611-4c4a-9ed9-28bd25b33625/documents/IUC5-5dd19cd8-d725-400b-a263-4348aa3c6be1_6fcfd8c5-61b0-4014-953f-eb4531e4c129.html,,,,,, Caryophyllene,87-44-5, No mortality or signs of toxicity were observed up to 5000 mg/kg in mice by oral administration. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f68a72ad-b7ef-4f66-8865-b7d4537c778a/documents/5b083e28-97ca-4250-92d8-2211c8520548_117a9e1a-013e-45f1-9a6b-47678bf68863.html,,,,,, Caryophyllene,87-44-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f68a72ad-b7ef-4f66-8865-b7d4537c778a/documents/5b083e28-97ca-4250-92d8-2211c8520548_117a9e1a-013e-45f1-9a6b-47678bf68863.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one",14901-07-6,"Repeated dose toxicity (Oral): OECD 408 study (GLP) with the target substance (rats; dietary): The no-observed-effect-level (NOEL) under the conditions of the present study was 100 ppm for both sexes (about 7 and 8 mg/kg bw/day for males and females) based on adaptive liver effects in both sexes and minor urine findings in males at 1000 ppm which correspond to a dosage of 72 and 83 mg/kg bw/day for males and females (no-observed-adverse-effect-level, NOAEL). The lowest-observed-adverse-effect-level (LOAEL) was found at 10 000 ppm (720 and 801 mg/kg bw/day for males and females) due to liver, kidney and thyroid findings in both sexes.   OECD 408 study (GLP) with a source substance (rats; oral gavage): The male rat NOAEL was considered at 5 mg/kg bw/day based on histopathological changes in kidneys at 30 and 500 mg/kg bw/day (which were not considered relevant for humans) and the female rat NOAEL was considered at 500 mg/kg bw/day.   17-week study with a source substance (rats; dietary): The rat NOAEL was considered at 10000 ppm for both genders. Swelling of parenchymal cells in the liver was reported at all dose levels (very slight at 1000 ppm; slight at 2500 ppm; and slight to moderate at 10000 ppm). This effect was most likely an adaptive response to treatment due to increased metabolic demand of the liver.   Repeated dose toxicity (Inhalation): The No Observed Adverse Effect Concentration (NOAEC) beta ionone on Sprague–Dawley rats in 13 weeks study was observed at dose concentration of 7.5 mg/l of air   Repeated dose toxicity study (Dermal): a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment  ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5ed50a8-8e96-40ec-9222-6291fadbdede/documents/0936d91c-3f64-4307-91ff-0eafbfc0e6a2_2a1f8aee-1521-428e-bb80-8765e5525caf.html,,,,,, "4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one",14901-07-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5ed50a8-8e96-40ec-9222-6291fadbdede/documents/0936d91c-3f64-4307-91ff-0eafbfc0e6a2_2a1f8aee-1521-428e-bb80-8765e5525caf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,72 mg/kg bw/day,,rat "4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one",14901-07-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5ed50a8-8e96-40ec-9222-6291fadbdede/documents/0936d91c-3f64-4307-91ff-0eafbfc0e6a2_2a1f8aee-1521-428e-bb80-8765e5525caf.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,7.5 mg/m3,,rat "4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one",14901-07-6,Acute oral toxicity study of the test substance beta ionone (CAS 14901-07-6) was performed on the rats via gavage route. The LD50 value was found to be 7120 mg/kg(7.12 g/kg) bw thus based on the CLP criteria it was concluded that the test substance was found to be not classified for oral toxicity study. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5ed50a8-8e96-40ec-9222-6291fadbdede/documents/e9c0a208-e686-4615-8d47-5001beb73c75_2a1f8aee-1521-428e-bb80-8765e5525caf.html,,,,,, "4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one",14901-07-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5ed50a8-8e96-40ec-9222-6291fadbdede/documents/e9c0a208-e686-4615-8d47-5001beb73c75_2a1f8aee-1521-428e-bb80-8765e5525caf.html,,oral,LD50,"7,120 mg/kg bw",no adverse effect observed, "4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one",14901-07-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5ed50a8-8e96-40ec-9222-6291fadbdede/documents/e9c0a208-e686-4615-8d47-5001beb73c75_2a1f8aee-1521-428e-bb80-8765e5525caf.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "4-(2,6,6-trimethylcyclohex-1-ene-1-yl)-but-3-ene-2-one",14901-07-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5ed50a8-8e96-40ec-9222-6291fadbdede/documents/e9c0a208-e686-4615-8d47-5001beb73c75_2a1f8aee-1521-428e-bb80-8765e5525caf.html,,inhalation,LC50,> 5.27 mg/L,no adverse effect observed, 2-cyclododecylpropan-1-ol,118562-73-5,The LD50 value for male and female animals p.o. is greather than 10 000 mg/kg bw.The LD50 value for male and female animals dermal is greather than 2 000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8297ef83-e3cf-4438-bd9d-baae2e03ecda/documents/IUC5-10d7977c-3553-4b62-8d52-9ec2267f2dbb_5af374ed-3ed1-4f86-bf7e-f80b0931364c.html,,,,,, 2-cyclododecylpropan-1-ol,118562-73-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8297ef83-e3cf-4438-bd9d-baae2e03ecda/documents/IUC5-10d7977c-3553-4b62-8d52-9ec2267f2dbb_5af374ed-3ed1-4f86-bf7e-f80b0931364c.html,,oral,discriminating dose,"10,000 mg/kg bw",adverse effect observed, 2-cyclododecylpropan-1-ol,118562-73-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8297ef83-e3cf-4438-bd9d-baae2e03ecda/documents/IUC5-10d7977c-3553-4b62-8d52-9ec2267f2dbb_5af374ed-3ed1-4f86-bf7e-f80b0931364c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Betaine,107-43-7," Betaine has been tested previously for acute toxicity and it is not classified (11179 mg/kg bw/day). Betaine has also been tested for sub-acute (28-day reversibility), sub-chronic (14-day range finding + 90-day sub-chronic), chronic toxicity (52-week) and carcinogenicity (104-week). In all of these tests betaine did not cause any adverse effects, chronic toxic properties or carcinogenic properties up to 5% oral feed (500 times expected exposure for human), therefore No Effect Levels and other descriptors could not be identified and calculated. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff86bf1f-7ce7-46a6-9b4f-d91e968b4cd7/documents/84339bdc-ad62-4a6e-b4ff-313ce5c5c24a_34e6119a-921b-4e55-9108-3d326bb4f50b.html,,,,,, Betaine,107-43-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff86bf1f-7ce7-46a6-9b4f-d91e968b4cd7/documents/84339bdc-ad62-4a6e-b4ff-313ce5c5c24a_34e6119a-921b-4e55-9108-3d326bb4f50b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat Betaine,107-43-7," The study for oral acute toxicity was conducted according to OECD technical guideline 401, in accordance with GLP. LD50-value in rats was determined to be 11179 mg/kg bw. For acute dermal toxicity, it is unnecessary and unjustified to test the toxicity of betaine, based on the results of skin irritation and skin sensitisation testing. For inhalation toxicity testing, it is scientifically unjustified and technically not possible to carry out the testing based on the properties of the substance. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff86bf1f-7ce7-46a6-9b4f-d91e968b4cd7/documents/48daef42-dfac-47f0-905d-91d203d26a55_34e6119a-921b-4e55-9108-3d326bb4f50b.html,,,,,, Betaine,107-43-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff86bf1f-7ce7-46a6-9b4f-d91e968b4cd7/documents/48daef42-dfac-47f0-905d-91d203d26a55_34e6119a-921b-4e55-9108-3d326bb4f50b.html,,oral,LD50,"11,179 mg/kg bw",, "3,3'-oxybis(ethyleneoxy)bis(propylamine)",4246-51-9,"OECD 422, rat, gavage (GLP, reliability 1, 2013): NOAEL systemic toxicity: 600 mg/kg bw/d NOAEL local toxicity: 100 mg/kg bw/d (females) NOAEL local toxicity: <100 mg/kg bw/d (males)   OECD 408, rat, gavage (GLP, reliability 1, 2023): NOAEL systemic toxicity = 600 mg/kg bw/d NOAEL local toxicity = 200 mg/kg bw/d ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a1f4c51-4c79-4ed8-bf41-e0faab547b4e/documents/IUC5-d3e4477f-1337-49f9-97e1-79c3185f45e2_5483a543-e352-4d7c-af9c-6313f7f9412b.html,,,,,, "3,3'-oxybis(ethyleneoxy)bis(propylamine)",4246-51-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a1f4c51-4c79-4ed8-bf41-e0faab547b4e/documents/IUC5-d3e4477f-1337-49f9-97e1-79c3185f45e2_5483a543-e352-4d7c-af9c-6313f7f9412b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,>= 600 mg/kg bw/day,,rat "3,3'-oxybis(ethyleneoxy)bis(propylamine)",4246-51-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a1f4c51-4c79-4ed8-bf41-e0faab547b4e/documents/IUC5-d3e4477f-1337-49f9-97e1-79c3185f45e2_5483a543-e352-4d7c-af9c-6313f7f9412b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,>= 600 mg/kg bw/day,,rat "3,3'-oxybis(ethyleneoxy)bis(propylamine)",4246-51-9,"oral: similar OECD 401, non-GLP, reliability 2, rat: LD50 =2850 mg/kg bw (male) rats; LD50 = 3160 mg/kg bw (female) dermal: similar to OECD 402, non-GLP, reliability 2, rat: LD50 > 2150 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a1f4c51-4c79-4ed8-bf41-e0faab547b4e/documents/IUC5-d53a7b7f-7fe2-4b16-8a80-a6468de3477f_5483a543-e352-4d7c-af9c-6313f7f9412b.html,,,,,, "3,3'-oxybis(ethyleneoxy)bis(propylamine)",4246-51-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a1f4c51-4c79-4ed8-bf41-e0faab547b4e/documents/IUC5-d53a7b7f-7fe2-4b16-8a80-a6468de3477f_5483a543-e352-4d7c-af9c-6313f7f9412b.html,,oral,LD50,"2,850 mg/kg bw",adverse effect observed, "3,3'-oxybis(ethyleneoxy)bis(propylamine)",4246-51-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a1f4c51-4c79-4ed8-bf41-e0faab547b4e/documents/IUC5-d53a7b7f-7fe2-4b16-8a80-a6468de3477f_5483a543-e352-4d7c-af9c-6313f7f9412b.html,,dermal,LD50,"2,150 mg/kg bw",adverse effect observed, 3-{2-[2-(3-azaniumylpropoxy)ethoxy]ethoxy}propan-1-aminium di[(2Z)-3-carboxyprop-2-enoate],1629579-82-3," Repeated dose toxicity: oral. 33Oxy.001 Under the conditions of the study, the NOAEL has been determined as 600 mg/kg bw/day in relation to parental systemic toxicity (male/female); 100 mg/kg bw/day in relation to local effect (female – histopathology (lesions in the upper digestive tract at all dose levels) and < 100 mg/kg bw/day in relation to local effect (male – histopathology (lesions in the upper digestive tract at all dose levels). Repeated dose toxicity: oral. Maleic Acid_RA to Maleic Anhydride.002 The NOEL of a 90-days dietary feeding study with Maleic Anhydride to Beagle dogs was 60 mg/kg/day, which was the highest concentration tested. Repeated dose toxicity: oral. Maleic Acid_RA to Maleic Anhydride.003 The LOEL of a 2-years dietary feeding study with rats was 32 mg/kg/day, the NOEL was 10 mg/kg/day. Repeated dose toxicity: oral. Maleic Acid.004 Toxic effects were observed at concentrations of 0.5 %, 1 % and 1.5 % of maleic acid in the diet, fed to male rats for two years. The main findings were increased mortality rate, reduced body weight/body weight gain and histopathological changes in liver, testis and kidneys. Repeated dose toxicity: oral. Maleic Acid_RA to Maleic Anhydride.005 The NOEL of a 90-days dietary feeding study with rats was 40 mg/kg/day, which was the highest concentration tested. Repeated dose toxicity: oral. Maleic Acid_RA to Maleic Anhydride.006 The LOEL of a 90-days dietary feeding study with rats was 100 mg/kg/day, which was the lowest concentration tested. Repeated dose toxicity: oral. Maleic Acid_RA to Maleic Anhydride.007 The LOEL of a 183-days dietary feeding study with rats was 250 mg/kg/day, which was the lowest concentration tested. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c565884-30fe-4cca-8140-7400d7037dae/documents/7d27be2e-f708-4355-b9fc-e769d1486ed2_a4b0c591-54c0-4c14-86b2-8f806dbd8a2e.html,,,,,, 3-{2-[2-(3-azaniumylpropoxy)ethoxy]ethoxy}propan-1-aminium di[(2Z)-3-carboxyprop-2-enoate],1629579-82-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c565884-30fe-4cca-8140-7400d7037dae/documents/7d27be2e-f708-4355-b9fc-e769d1486ed2_a4b0c591-54c0-4c14-86b2-8f806dbd8a2e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 3-{2-[2-(3-azaniumylpropoxy)ethoxy]ethoxy}propan-1-aminium di[(2Z)-3-carboxyprop-2-enoate],1629579-82-3, Acute Oral Acute toxicity: oral. 33Oxy.001 The Oral LD50 of the test substance was determined to be 3160 mg/kg bw in male and female rats. This substance is classified as OECD GHS Toxicity Category V for oral toxicity. Acute toxicity: oral. MA.002 The Oral LD50 of Maleic acid was determined to be 2870 (2470-3250) mg/kg bw or Oral LD50=2382.1 (2050.1-2697.5) mg/kg bw. This substance is classified as OECD GHS Toxicity Category V for oral toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c565884-30fe-4cca-8140-7400d7037dae/documents/b3ded67e-2fee-4d46-919e-aa7ab9a026c8_a4b0c591-54c0-4c14-86b2-8f806dbd8a2e.html,,,,,, 3-{2-[2-(3-azaniumylpropoxy)ethoxy]ethoxy}propan-1-aminium di[(2Z)-3-carboxyprop-2-enoate],1629579-82-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c565884-30fe-4cca-8140-7400d7037dae/documents/b3ded67e-2fee-4d46-919e-aa7ab9a026c8_a4b0c591-54c0-4c14-86b2-8f806dbd8a2e.html,,oral,LD50,"2,470 mg/kg bw",no adverse effect observed, 3-{2-[2-(3-azaniumylpropoxy)ethoxy]ethoxy}propan-1-aminium di[(2Z)-3-carboxyprop-2-enoate],1629579-82-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c565884-30fe-4cca-8140-7400d7037dae/documents/b3ded67e-2fee-4d46-919e-aa7ab9a026c8_a4b0c591-54c0-4c14-86b2-8f806dbd8a2e.html,,dermal,LD50,"2,150 mg/kg bw",adverse effect observed, "2,2'-[6-(4-methoxyphenyl)-1,3,5-triazine-2,4-diyl]bis{5-[(2-ethylhexyl)oxy]phenol}",187393-00-6,"90 day NOAEL (Oral, rat): >= 1000 mg/kg bw 90 day NOAEL (Dermal, rat): >= 1000 mg/kg bw ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f50c9bc0-48ad-42f3-adc7-c7ccd90703f0/documents/5fb184b6-959d-4985-be92-e7d52ebd9a16_f0048deb-0beb-412b-9021-77d7cf3b3600.html,,,,,, "2,2'-[6-(4-methoxyphenyl)-1,3,5-triazine-2,4-diyl]bis{5-[(2-ethylhexyl)oxy]phenol}",187393-00-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f50c9bc0-48ad-42f3-adc7-c7ccd90703f0/documents/5fb184b6-959d-4985-be92-e7d52ebd9a16_f0048deb-0beb-412b-9021-77d7cf3b3600.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2'-[6-(4-methoxyphenyl)-1,3,5-triazine-2,4-diyl]bis{5-[(2-ethylhexyl)oxy]phenol}",187393-00-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f50c9bc0-48ad-42f3-adc7-c7ccd90703f0/documents/5fb184b6-959d-4985-be92-e7d52ebd9a16_f0048deb-0beb-412b-9021-77d7cf3b3600.html,Chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "2,2'-[6-(4-methoxyphenyl)-1,3,5-triazine-2,4-diyl]bis{5-[(2-ethylhexyl)oxy]phenol}",187393-00-6,"LD50, oral rat: >2000 mg/kg bwLC50, inhal rat: > 0.649 mg/L (active ingredient)LD50, dermal rat: >2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f50c9bc0-48ad-42f3-adc7-c7ccd90703f0/documents/f85e522c-ba5c-49b6-9a40-a7606e6ac386_f0048deb-0beb-412b-9021-77d7cf3b3600.html,,,,,, "2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)propane-1,3-diol",6976-37-0,"Based on the observations after oral treatment with the test item in a study conducted according to OECD 422 in rats the No Observed Adverse Effect Levels (NOAEL) for systemic toxicity of male/female rats was determined to be 1000 mg/kg bw/d (reference 7.5.1-1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study is considered of sufficient quality as it is a well described GLP compliant study conducted to recognized international test guidelines. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/145a77c8-ac74-4cb1-8c56-8ff42c07e3a9/documents/31cec4f1-b0c1-4a01-98e2-fe492d764585_cd34d4f0-a237-4060-b1c9-fbd288995ed2.html,,,,,, "2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)propane-1,3-diol",6976-37-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/145a77c8-ac74-4cb1-8c56-8ff42c07e3a9/documents/31cec4f1-b0c1-4a01-98e2-fe492d764585_cd34d4f0-a237-4060-b1c9-fbd288995ed2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)propane-1,3-diol",6976-37-0,"In a GLP-study according to OECD TG 423 (acute class method) with rats, the LD50 of the substance was determined as > 2000 mg/kg bw (reference 7.2.1-1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available study is of high quality and reliable without restrictions. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/145a77c8-ac74-4cb1-8c56-8ff42c07e3a9/documents/c5792a6f-6d36-4564-aad5-e56a1209ab35_cd34d4f0-a237-4060-b1c9-fbd288995ed2.html,,,,,, "2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)propane-1,3-diol",6976-37-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/145a77c8-ac74-4cb1-8c56-8ff42c07e3a9/documents/c5792a6f-6d36-4564-aad5-e56a1209ab35_cd34d4f0-a237-4060-b1c9-fbd288995ed2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,5,7,10-tetraoxaundecane",4431-83-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Good quality from OECD 410 and GLP study (KC1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Good quality from read-across preformed according to OECD Joint meeting of the chemicals committee and the working party on chemical, pesticides and biotechnology, Guidance on grouping of chemicals, ENV/JM/MONO(2007)28 (KC2) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8eb94471-2d07-4207-96b4-327b24604737/documents/IUC5-4830d7f4-250d-4602-b4ef-4aae0cc265fa_367a2a93-3139-4221-8685-f78e95ff0d48.html,,,,,, "2,5,7,10-tetraoxaundecane",4431-83-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8eb94471-2d07-4207-96b4-327b24604737/documents/IUC5-4830d7f4-250d-4602-b4ef-4aae0cc265fa_367a2a93-3139-4221-8685-f78e95ff0d48.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "2,5,7,10-tetraoxaundecane",4431-83-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8eb94471-2d07-4207-96b4-327b24604737/documents/IUC5-4830d7f4-250d-4602-b4ef-4aae0cc265fa_367a2a93-3139-4221-8685-f78e95ff0d48.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"3,127.89 mg/m3",,rat "2,5,7,10-tetraoxaundecane",4431-83-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The test was performed according to OECD TG 423 and GLP (Klimisch code 1). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The test was performed according to OECD TG 402 and GLP (Klimisch code 1). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8eb94471-2d07-4207-96b4-327b24604737/documents/IUC5-e89c11ef-bebf-4cd7-9c18-455fd4348ee8_367a2a93-3139-4221-8685-f78e95ff0d48.html,,,,,, "2,5,7,10-tetraoxaundecane",4431-83-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8eb94471-2d07-4207-96b4-327b24604737/documents/IUC5-e89c11ef-bebf-4cd7-9c18-455fd4348ee8_367a2a93-3139-4221-8685-f78e95ff0d48.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,5,7,10-tetraoxaundecane",4431-83-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8eb94471-2d07-4207-96b4-327b24604737/documents/IUC5-e89c11ef-bebf-4cd7-9c18-455fd4348ee8_367a2a93-3139-4221-8685-f78e95ff0d48.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dimethylbis(octadecyloxy)silane,29043-70-7," The key 28-day oral study, conducted according to OECD TG 407, and in compliance with GLP, reported a NOAEL value for dimethylbis(octadecyloxy)silane of ≥1000 mg/kg bw in rats (RCC, 1999). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/988782f2-f421-40ca-bec6-344de184a398/documents/6d6e1544-9b09-4c4d-8025-f815a54a68de_c0bc7f27-e3db-4b45-be6e-e6d54c2ad914.html,,,,,, Dimethylbis(octadecyloxy)silane,29043-70-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/988782f2-f421-40ca-bec6-344de184a398/documents/6d6e1544-9b09-4c4d-8025-f815a54a68de_c0bc7f27-e3db-4b45-be6e-e6d54c2ad914.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dimethylbis(octadecyloxy)silane,29043-70-7," Acute oral toxicity: LD₅₀ >2000 mg/kg bw OECD Guideline 401, GLP compliant (RTC, 1996). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/988782f2-f421-40ca-bec6-344de184a398/documents/67542bf9-1815-4987-ae48-215e5818ba4b_c0bc7f27-e3db-4b45-be6e-e6d54c2ad914.html,,,,,, Dimethylbis(octadecyloxy)silane,29043-70-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/988782f2-f421-40ca-bec6-344de184a398/documents/67542bf9-1815-4987-ae48-215e5818ba4b_c0bc7f27-e3db-4b45-be6e-e6d54c2ad914.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide",162881-26-7,Study conducted to generally recognised scientific standards with GLP. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b92bd09-37bb-43c9-a457-f10073c72343/documents/eb16c264-ee6d-4444-bc21-e07adc237ebc_0d849689-ff29-4736-8c9b-eae4a201df7a.html,,,,,, "Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide",162881-26-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b92bd09-37bb-43c9-a457-f10073c72343/documents/eb16c264-ee6d-4444-bc21-e07adc237ebc_0d849689-ff29-4736-8c9b-eae4a201df7a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide",162881-26-7,"An acute oral toxicity study conducted according to the OECD TG 401 (1987) and to GLP is available (Huntington Life Science Ltd 964053). An acute dermal toxicity study conducted according to the OECD TG 402 (1987) and to GLP is available (Huntingdon Life Sciences Ltd 964054).For each of the acute oral and dermal route of exposure, the LD50 is > 2000 mg/kg bw.No inhalation study is available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b92bd09-37bb-43c9-a457-f10073c72343/documents/730a56b6-5382-4d56-8e53-4cca77e41560_0d849689-ff29-4736-8c9b-eae4a201df7a.html,,,,,, "Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide",162881-26-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b92bd09-37bb-43c9-a457-f10073c72343/documents/730a56b6-5382-4d56-8e53-4cca77e41560_0d849689-ff29-4736-8c9b-eae4a201df7a.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Phenyl bis(2,4,6-trimethylbenzoyl)-phosphine oxide",162881-26-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b92bd09-37bb-43c9-a457-f10073c72343/documents/730a56b6-5382-4d56-8e53-4cca77e41560_0d849689-ff29-4736-8c9b-eae4a201df7a.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Levomenol,23089-26-1," The LD50 of Candeia Oil after oral administration was found to be > 2000 mg/kg bw for male and female rats (reference 7.2.1 -1). Candeia Oil (source substance), which is a plant extract containing (+/-)-α-Bisabolol as main constituent, is considered to be a suitable read across substance for (-)-α-Bisabolol (target substance). Therefore, it can be assumed that the LD50 of (-)-α-Bisabolol is also > 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e9c4d30-faf6-4eb4-9d4e-6e627a11d8e7/documents/a4486b02-15e7-4a3d-81a8-d5e2be388e8a_0b93798c-3396-459a-b60b-14d95483d89d.html,,,,,, Levomenol,23089-26-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e9c4d30-faf6-4eb4-9d4e-6e627a11d8e7/documents/a4486b02-15e7-4a3d-81a8-d5e2be388e8a_0b93798c-3396-459a-b60b-14d95483d89d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bismuth citrate,813-93-4,"The NOAEL was determined to be 1000 mg/kg bw/day for male and female rats in a 90 day repeated dose study (OECD 408) via the oral route with read-across substance, bismuth subnitrate. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56457f31-c1cd-47d6-b228-c3ead2536ee8/documents/IUC5-f7461be6-1332-43fc-807b-859f5a44f8f8_3bc65fab-e4b0-482c-8c01-a5f4f4cd7448.html,,,,,, Bismuth citrate,813-93-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56457f31-c1cd-47d6-b228-c3ead2536ee8/documents/IUC5-f7461be6-1332-43fc-807b-859f5a44f8f8_3bc65fab-e4b0-482c-8c01-a5f4f4cd7448.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Bismuth citrate,813-93-4,"Bismuth citrate is not acutely toxic via the oral route based on read-across to related substance, bismuth subsalicylate. By read across, bismuth citrate is not acutely toxic via the inhalation route. Acute toxicity via the dermal route was not tested. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56457f31-c1cd-47d6-b228-c3ead2536ee8/documents/IUC5-78b468d7-d6aa-46b5-a4ce-3cb240ce8824_3bc65fab-e4b0-482c-8c01-a5f4f4cd7448.html,,,,,, Bismuth citrate,813-93-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56457f31-c1cd-47d6-b228-c3ead2536ee8/documents/IUC5-78b468d7-d6aa-46b5-a4ce-3cb240ce8824_3bc65fab-e4b0-482c-8c01-a5f4f4cd7448.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Bismuth citrate,813-93-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56457f31-c1cd-47d6-b228-c3ead2536ee8/documents/IUC5-78b468d7-d6aa-46b5-a4ce-3cb240ce8824_3bc65fab-e4b0-482c-8c01-a5f4f4cd7448.html,,inhalation,LC50,"5,070 mg/m3",no adverse effect observed, Bismuth hydroxide nitrate oxide,1304-85-4,The NOAEL was determined to be 1000 mg/kg bw/day for male and female rats in a 90 day repeated dose study (OECD 408) via the oral route with bismuth subnitrate. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/474f4762-6f80-477e-ad4d-4b624fbe0ce0/documents/IUC5-d116bf67-f887-40d3-b5e8-adebe6af6875_303a0c09-710d-4634-9157-4c4b272f1374.html,,,,,, Bismuth hydroxide nitrate oxide,1304-85-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/474f4762-6f80-477e-ad4d-4b624fbe0ce0/documents/IUC5-d116bf67-f887-40d3-b5e8-adebe6af6875_303a0c09-710d-4634-9157-4c4b272f1374.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Bismuth hydroxide nitrate oxide,1304-85-4,"By read across to bismuth subsalicylate, bismuth subnitrate is not acutely toxic via the oral route. By read across to dibismuth trioxide, bismuth subnitrate is not acutely toxic via the inhalation route. Acute toxicity via the dermal route was not tested. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/474f4762-6f80-477e-ad4d-4b624fbe0ce0/documents/IUC5-36db7fa6-cfef-423b-9d5f-0d9be5d2fb5c_303a0c09-710d-4634-9157-4c4b272f1374.html,,,,,, Bismuth hydroxide nitrate oxide,1304-85-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/474f4762-6f80-477e-ad4d-4b624fbe0ce0/documents/IUC5-36db7fa6-cfef-423b-9d5f-0d9be5d2fb5c_303a0c09-710d-4634-9157-4c4b272f1374.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Bismuth hydroxide nitrate oxide,1304-85-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/474f4762-6f80-477e-ad4d-4b624fbe0ce0/documents/IUC5-36db7fa6-cfef-423b-9d5f-0d9be5d2fb5c_303a0c09-710d-4634-9157-4c4b272f1374.html,,inhalation,LC50,"5,070 mg/m3",no adverse effect observed, "1,1'-isopropylidenebis(p-phenyleneoxy)dipropan-2-ol",116-37-0," No relevant treatment-related findings were observed for clinical signs, clinical biochemistry, histopathological or reproductive parameters up to the dose-level of 180 mg/kg bw/day in a 90-day repeated toxicity study (OECD 408). Treatment related toxicity including mortality was evident at 250 and 500 mg/kg in a Combined 28 -day and reproduction screening study (OECD 422). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/839e4703-3872-42d6-a45e-97b54d943e5b/documents/35cb6d9a-b006-42be-92ac-f801d06f1b9d_0a3f460f-04cd-4099-8d20-4878e1c6c93b.html,,,,,, "1,1'-isopropylidenebis(p-phenyleneoxy)dipropan-2-ol",116-37-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/839e4703-3872-42d6-a45e-97b54d943e5b/documents/35cb6d9a-b006-42be-92ac-f801d06f1b9d_0a3f460f-04cd-4099-8d20-4878e1c6c93b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,180 mg/kg bw/day,,rat "1,1'-isopropylidenebis(p-phenyleneoxy)dipropan-2-ol",116-37-0,"An acute oral and dermal toxicity studies with rats are available, both showing LD50 values >2000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Study performed in 1975, no GLP, but considered appropriate for the endpoint. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study has been performed according to OECD and/or EC guidelines and according to GLP principles. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/839e4703-3872-42d6-a45e-97b54d943e5b/documents/712b97ab-47ce-44ff-b34a-01cff243be84_0a3f460f-04cd-4099-8d20-4878e1c6c93b.html,,,,,, "1,1'-isopropylidenebis(p-phenyleneoxy)dipropan-2-ol",116-37-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/839e4703-3872-42d6-a45e-97b54d943e5b/documents/712b97ab-47ce-44ff-b34a-01cff243be84_0a3f460f-04cd-4099-8d20-4878e1c6c93b.html,,oral,LD50,"2,760 mg/kg bw",adverse effect observed, "1,1'-isopropylidenebis(p-phenyleneoxy)dipropan-2-ol",116-37-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/839e4703-3872-42d6-a45e-97b54d943e5b/documents/712b97ab-47ce-44ff-b34a-01cff243be84_0a3f460f-04cd-4099-8d20-4878e1c6c93b.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, Boric acid,10043-35-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The key study provides BMD which is based on results of two studies and therefore is more accurate and more precise than NOAEL established in one study. The oral BMD has been extrapolated to inhalation BMD of 103.9 mg/m³ for zinc borate anhydrous by route-to-route extrapolation (see section ""DNEL derivation""). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study meets generally accepted scientific standards with acceptable restrictions. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ade282f5-ea48-4e41-b61e-db6215a2b2ee/documents/43ae6ef8-c151-4697-a85d-e8335dfe3bfe_0d9402ee-1e54-4e43-8d65-e2ed52ce3eee.html,,,,,, Boric acid,10043-35-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ade282f5-ea48-4e41-b61e-db6215a2b2ee/documents/43ae6ef8-c151-4697-a85d-e8335dfe3bfe_0d9402ee-1e54-4e43-8d65-e2ed52ce3eee.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,103.9 mg/m3,,rat Boric acid,10043-35-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ade282f5-ea48-4e41-b61e-db6215a2b2ee/documents/43ae6ef8-c151-4697-a85d-e8335dfe3bfe_0d9402ee-1e54-4e43-8d65-e2ed52ce3eee.html,Chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Boric acid,10043-35-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): High quality (there are a lot of reliable studies for different species available). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): High quality (3 reliable studies available). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Guideline study. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ade282f5-ea48-4e41-b61e-db6215a2b2ee/documents/127231f7-781f-4b37-a638-63d8b28c0e6c_0d9402ee-1e54-4e43-8d65-e2ed52ce3eee.html,,,,,, Boric acid,10043-35-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ade282f5-ea48-4e41-b61e-db6215a2b2ee/documents/127231f7-781f-4b37-a638-63d8b28c0e6c_0d9402ee-1e54-4e43-8d65-e2ed52ce3eee.html,,oral,LD50,"3,765 mg/kg bw",no adverse effect observed, Boric acid,10043-35-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ade282f5-ea48-4e41-b61e-db6215a2b2ee/documents/127231f7-781f-4b37-a638-63d8b28c0e6c_0d9402ee-1e54-4e43-8d65-e2ed52ce3eee.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Boric acid,10043-35-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ade282f5-ea48-4e41-b61e-db6215a2b2ee/documents/127231f7-781f-4b37-a638-63d8b28c0e6c_0d9402ee-1e54-4e43-8d65-e2ed52ce3eee.html,,inhalation,LC50,"2,000 mg/m3",no adverse effect observed, DL-borneol,507-70-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): the result is reliable ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1f27a5d-9b61-4207-931d-918f27b5124e/documents/47f77eae-3490-4480-ad06-8a0152dd4592_7a03c3ef-0024-4db0-b215-d47bba8a5c6d.html,,,,,, DL-borneol,507-70-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1f27a5d-9b61-4207-931d-918f27b5124e/documents/47f77eae-3490-4480-ad06-8a0152dd4592_7a03c3ef-0024-4db0-b215-d47bba8a5c6d.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,250 mg/kg bw/day,,rat DL-borneol,507-70-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): peer-reviewed Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): peer-reviewed ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1f27a5d-9b61-4207-931d-918f27b5124e/documents/bd6726d0-2f7c-40db-a06f-e538ce9d10cb_7a03c3ef-0024-4db0-b215-d47bba8a5c6d.html,,,,,, DL-borneol,507-70-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1f27a5d-9b61-4207-931d-918f27b5124e/documents/bd6726d0-2f7c-40db-a06f-e538ce9d10cb_7a03c3ef-0024-4db0-b215-d47bba8a5c6d.html,,oral,LD50,"1,310 mg/kg bw",adverse effect observed, DL-borneol,507-70-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1f27a5d-9b61-4207-931d-918f27b5124e/documents/bd6726d0-2f7c-40db-a06f-e538ce9d10cb_7a03c3ef-0024-4db0-b215-d47bba8a5c6d.html,,inhalation,LC50,500 mg/m3,adverse effect observed, "Bulnesia sarmienti, ext.",89958-10-1,Acute oral toxicity: LD50 >5000 mg/kg bw (similar to OECD 401) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23b877c7-4911-46ea-a163-82800e35d348/documents/IUC5-f812751c-a157-4375-9f96-264749e88a0c_c4f91e0f-84d2-4e1c-90b1-4be72915b929.html,,,,,, "Bulnesia sarmienti, ext.",89958-10-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23b877c7-4911-46ea-a163-82800e35d348/documents/IUC5-f812751c-a157-4375-9f96-264749e88a0c_c4f91e0f-84d2-4e1c-90b1-4be72915b929.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Bulnesia sarmienti, ext., acetate",94333-88-7,Acute oral toxicity: similar to OECD TG 401: LD50 is 10000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fd9fc83-82f8-4165-a09a-4a7f719bc734/documents/6251ae07-bb7d-4bc7-b1a6-e84958b6e5aa_6ba8cae3-04ef-4c0c-9eee-394a33830b55.html,,,,,, Bumetrizole,3896-11-5,"Subacute studies: NOAEL(rat) = ca. 1000 (male and female) mg/kg bw /d (highest dose tested)Subchronic studies: NOAEL (rat) = 637 (male), 740 (female) mg/kg bw/d (highest dose tested)Subchronic studies: NOAEL (dog) = 153 (female), 168 (male) mg/kg bw/d (highest dose tested) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da87bb42-f3ec-4759-8218-4199227bd26a/documents/IUC5-4593c556-0ca4-43a6-85a7-e34203c8442f_b7cde285-7c6b-45c9-b0d6-a6d8c17703e4.html,,,,,, Bumetrizole,3896-11-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da87bb42-f3ec-4759-8218-4199227bd26a/documents/IUC5-4593c556-0ca4-43a6-85a7-e34203c8442f_b7cde285-7c6b-45c9-b0d6-a6d8c17703e4.html,Chronic toxicity – systemic effects,oral,NOAEL,113 mg/kg bw/day,,rat Bumetrizole,3896-11-5," The test substance was practically non toxic in rats after a single dose oral or a 24 hour dermal exposure to the test substance, each route producing an LD50 greater than 2,000 mg/kg bw in male and female animals. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da87bb42-f3ec-4759-8218-4199227bd26a/documents/IUC5-1e091675-29b1-49fe-8c99-1844314ba9d2_b7cde285-7c6b-45c9-b0d6-a6d8c17703e4.html,,,,,, Bumetrizole,3896-11-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da87bb42-f3ec-4759-8218-4199227bd26a/documents/IUC5-1e091675-29b1-49fe-8c99-1844314ba9d2_b7cde285-7c6b-45c9-b0d6-a6d8c17703e4.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bumetrizole,3896-11-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da87bb42-f3ec-4759-8218-4199227bd26a/documents/IUC5-1e091675-29b1-49fe-8c99-1844314ba9d2_b7cde285-7c6b-45c9-b0d6-a6d8c17703e4.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Buta-1,3-diene",106-99-0,"1,3-Butadiene is a flammable gas at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. It exhibits marked species differences in repeat dose toxicity studies via inhalation exposure. It has low toxicity in the rat, with minimal effects seen after exposure to 8000 ppm (17,701 mg/m3) for 2 years. No chronic non-neoplastic effects were seen in humans, although data are limited. The mouse is the most sensitive species where the target organs are bone marrow, ovary, and testis. A NOAEC for repeat dose toxicity in the chronic studies has not been established due to neoplasia-related toxicity. Species differences in metabolism are believed to be responsible for the species-specific toxicity with humans being more similar to rats. The NOAEC for repeat dose toxicity is therefore 1000 ppm (2212 mg/m3) as defined by rat studies. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/863d1d14-b0d9-48fc-87c9-965728252bbf/documents/IUC5-abba2b36-f6ee-450d-a433-59e88b3c5998_e769d05f-dd7a-46c8-87d1-d8ea203aa2c9.html,,,,,, "Buta-1,3-diene",106-99-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/863d1d14-b0d9-48fc-87c9-965728252bbf/documents/IUC5-abba2b36-f6ee-450d-a433-59e88b3c5998_e769d05f-dd7a-46c8-87d1-d8ea203aa2c9.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"2,212 mg/m3",,rat "Buta-1,3-diene",106-99-0,"1,3-Butadiene is a flammable gas at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. Limited data suggest that 1,3-butadiene has low inhalational acute toxicity in both animals and humans. The acute inhalation LC50 of 1,3-butadiene in mice is 270,000 mg/m3 (122,024 ppm) and humans can tolerate an exposure concentration of 17,702 mg/m3 of (8000 ppm) for 8 hours without adverse symptoms.   The requirement for data on acute oral toxicity is waived in accordance with REACH Annex XI, as 1,3 -butadiene is a flammable gas at room temperature.   The quality of data on the acute inhalation toxicity of 1,3 -butadiene is given a reliability score of 4. This study, whilst containing limitations, still examines the key endpoint for acute toxicity, and is included here in addition to the numerous studies that been reported with human subjects. In the rat the LC50 value after a 4h exposure was 285,000 mg/m˄3 (128,803 ppm) and in the mouse was 270,000 mg/m˄3 (122,024 ppm) after 2h exposure. Rapid onset of narcosis was reported in both species (Shugaev, 1969). Similar results from other low quality studies are described in the EU RAR (2002). Volunteer studies have been carried out in humans. Unsteadiness was noted after exposure at 4000 ppm for 6 h and the odour was described as objectionable, but there was little effect at 8000 ppm (17,701 mg/m˄3) for 8h (Carpenter et al, 1944). Other human studies described in the EU RAR (2002) are stated to be “unreliable and of doubtful significance” and are not described here.   The requirement for data on acute dermal toxicity is waived in accordance with REACH Annex XI, as 1,3 -butadiene is a flammable gas at room temperature. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/863d1d14-b0d9-48fc-87c9-965728252bbf/documents/IUC5-d10e22f2-7526-4655-a946-ac7fd40f6151_e769d05f-dd7a-46c8-87d1-d8ea203aa2c9.html,,,,,, Butane,106-97-8," Members of the Petroleum Gases category show low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration for the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c81871f6-a482-432f-b312-2caeeeaf99b1/documents/b721eb2d-40a4-4218-82f6-fa011ddca2e8_1b5a449c-ca5a-4f1d-afad-851b475ffab2.html,,,,,, Butane,106-97-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c81871f6-a482-432f-b312-2caeeeaf99b1/documents/b721eb2d-40a4-4218-82f6-fa011ddca2e8_1b5a449c-ca5a-4f1d-afad-851b475ffab2.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"4,437 mg/m3",,rat Butane,106-97-8," The LC50 in mice of a mixture of isobutane, butane, and propane is 57.42% (approximately 539,600 ppm). The LC50 in rats of propane exceeds 800000 ppm (equivalent to 1,442,738 mg/m3 or 1443 mg/L)). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c81871f6-a482-432f-b312-2caeeeaf99b1/documents/e2a1c422-b9eb-4d66-96a7-2e6bdee5435c_1b5a449c-ca5a-4f1d-afad-851b475ffab2.html,,,,,, But-1-ene,106-98-9, Members of the butenes category are flammable gases at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. Members of the butenes category have low sub-chronic toxicity. Inhalation exposure is the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies of up to 2 years in rats or mice. Nasal lesions were observed in 2 year rodent studies at the highest concentration but are considered to be a non-adverse adaptation to chronic exposure to a hydrocarbon. Members of the butenes category are flammable gases at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. Members of the butenes category have low sub-chronic toxicity. Inhalation exposure is the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies of up to 2 years in rats or mice. Nasal lesions were observed in 2 year rodent studies at the highest concentration but are considered to be a non-adverse adaptation to chronic exposure to a hydrocarbon. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17bfd9ba-e45a-4fd0-a126-b7b16c4d991e/documents/6b665189-4f72-41a2-a8d5-6e3a12f6123f_a4e15e69-24b9-4e16-ab0d-c1ae2c19ddf1.html,,,,,, But-1-ene,106-98-9,"Members of the butenes category are flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. Members of the butenes category have low acute inhalation toxicity. The LC50 for but-2 -ene is greater than 10,000 ppm (22,948 mg/m3). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17bfd9ba-e45a-4fd0-a126-b7b16c4d991e/documents/a952f1cf-a06d-4ef5-ac6e-1ab8b1756557_a4e15e69-24b9-4e16-ab0d-c1ae2c19ddf1.html,,,,,, Butene,25167-67-3, Members of the butenes category are flammable gases at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. Members of the butenes category have low sub-chronic toxicity. Inhalation exposure is the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies of up to 2 years in rats or mice. Nasal lesions were observed in 2 year rodent studies at the highest concentration but are considered to be a non-adverse adaptation to chronic exposure to a hydrocarbon. Members of the butenes category are flammable gases at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. Members of the butenes category have low sub-chronic toxicity. Inhalation exposure is the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies of up to 2 years in rats or mice. Nasal lesions were observed in 2 year rodent studies at the highest concentration but are considered to be a non-adverse adaptation to chronic exposure to a hydrocarbon. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca759e9c-309a-46fa-b087-86f9032d264b/documents/a121a868-8584-4ce3-ad15-cdba1e8f20cc_372f50ff-b5a3-4fbe-b045-ee9da61d07fe.html,,,,,, Butene,25167-67-3,"Members of the butenes category are flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. Members of the butenes category have low acute inhalation toxicity. The LC50 for but-2 -ene is greater than 10,000 ppm (22,948 mg/m3). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca759e9c-309a-46fa-b087-86f9032d264b/documents/7feb8bdb-92d9-4f2c-83cf-595997105ca0_372f50ff-b5a3-4fbe-b045-ee9da61d07fe.html,,,,,, "4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one",13215-88-8," Oral (OECD 401), rat: LD50 calculated = 1203 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a76bfd4b-52fa-446f-9794-c074fd2aca95/documents/9e76a79f-6e57-4ed5-9a7f-ca61e6d7b56e_1c56e601-908b-4e1a-b63e-ba41f91f5f8a.html,,,,,, "4-(2-butenylidene)-3,5,5-trimethylcyclohex-2-en-1-one",13215-88-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a76bfd4b-52fa-446f-9794-c074fd2aca95/documents/9e76a79f-6e57-4ed5-9a7f-ca61e6d7b56e_1c56e601-908b-4e1a-b63e-ba41f91f5f8a.html,,oral,LD50,"1,203 mg/kg bw",adverse effect observed, 2-(2-butoxyethoxy)ethyl acetate,124-17-4," ORAL ROUTE (all rat) - NOAEL rat (for surrogate): 250mg/kg, LOAEL 1000mg/kg (90 day drinking water study). Molar equivalency is 315mg/kg and 1260mg/kg respectively. DERMAL - NOAEL rat (for surrogate): >2000ml/kg (13 week occlusive study)  equivalent to 2400mg/kg (rounded to 2 sig fig.)  max dose tested and no systemic effects seen ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e6430c8-f658-4c18-aa0c-c0f44e072ff0/documents/40d8fa71-f855-4716-a5e5-13ff9131eeec_c780fd3a-b653-44cb-a6d5-6fe8f2c6e0cb.html,,,,,, 2-(2-butoxyethoxy)ethyl acetate,124-17-4,"Acute oral toxicity (LD50): rat=11920mg/kg, 7.1ml/kg, guinea pig=2340mg/kg, 2.7ml/kg. mouse=6.6ml/kg, rabbit=2.8ml/kg, chicken=5.0ml/kg. Acute inhalation (LC50). Cannot be reached at saturated vapour concentration.Acute dermal toxicity (LD50) rabbit=5400-5700mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e6430c8-f658-4c18-aa0c-c0f44e072ff0/documents/9e9bdfe2-c15e-4d59-bebf-b199a4097ee5_c780fd3a-b653-44cb-a6d5-6fe8f2c6e0cb.html,,,,,, 2-(2-butoxyethoxy)ethyl acetate,124-17-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e6430c8-f658-4c18-aa0c-c0f44e072ff0/documents/9e9bdfe2-c15e-4d59-bebf-b199a4097ee5_c780fd3a-b653-44cb-a6d5-6fe8f2c6e0cb.html,,oral,LD50,"2,340 mg/kg bw",, 2-(2-butoxyethoxy)ethyl acetate,124-17-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e6430c8-f658-4c18-aa0c-c0f44e072ff0/documents/9e9bdfe2-c15e-4d59-bebf-b199a4097ee5_c780fd3a-b653-44cb-a6d5-6fe8f2c6e0cb.html,,dermal,LD50,"5,400 mg/kg bw",, 2-(2-butoxyethoxy)ethanol,112-34-5," ORAL ROUTE (all rat) - NOAEL 250mg/kg, LOAEL 1000mg/kg (90 day drinking water study). KEY STUDY - NOAEL 51-65mg/kg, LOAEL 254-327 mg/kg (90 day gavage study) - NOAEL 891mg/kg (6 week gavage study) - NOAEL 94mg/kg, LOAEL 650mg/kg (30 day drinking water study) - NOAEL 65mg/kg (F), 165mg/kg (M), LOAEL (marginal) 165mg/kg (F), 440mg/kg (M) approx. 28 day feeding study DERMAL - NOAEL 2000mg/kg (13 week occlusive study) (<200mg/kg for local effects - irritation) - NOAEL 2000mg/kg (13 week occlusive study) (600mg/kg for local effects - irritation) INHALATION - NOAEC 94mg/m3 (90 day study) - NOEC 39mg/m3 (5 week study).  NOAEC could be defined as 121mg/m3 - NOAEC 100mg/m3 (2 week rangefinder study) - LOAEC (aerosol form, 4 weeks) 254mg/m3 - LOAEC (aerosol form, 4 weeks) 350mg/m3 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7e3b982-395b-4ca3-afdc-80ed44f69f0c/documents/625815d8-7a63-4442-b61b-9b6ffacc0869_679a9b61-3330-431d-a6e0-7aed365204b1.html,,,,,, 2-(2-butoxyethoxy)ethanol,112-34-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7e3b982-395b-4ca3-afdc-80ed44f69f0c/documents/625815d8-7a63-4442-b61b-9b6ffacc0869_679a9b61-3330-431d-a6e0-7aed365204b1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 2-(2-butoxyethoxy)ethanol,112-34-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7e3b982-395b-4ca3-afdc-80ed44f69f0c/documents/625815d8-7a63-4442-b61b-9b6ffacc0869_679a9b61-3330-431d-a6e0-7aed365204b1.html,Repeated dose toxicity – local effects,inhalation,NOAEC,94 mg/m3,adverse effect observed,rat 2-(2-butoxyethoxy)ethanol,112-34-5," ORAL: Mouse, male: LD50=2410mg/kg (fasted animals), 5530mg/kg (fed animals) Rat, male: LD50=7291mg/kg (fasted animals), 9633mg/kg (fed animals) Rat, male: LD50=6560mg/kg Guinea pig, male/female: LD50=2000mg/kg Rat: LD50=3305, 5560mg/kg Rat: LD50>5080mg/kg Rabbit: LD50=2200mg/kg INHALATION: LD50 greater than saturated vapour pressure DERMAL Rabbit, male: LD50=2764mg/kg Rat: LD50>2000ml/kg (4 hour exposure only) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7e3b982-395b-4ca3-afdc-80ed44f69f0c/documents/758865f4-03cf-4076-9d06-5f0b01d31692_679a9b61-3330-431d-a6e0-7aed365204b1.html,,,,,, 2-(2-butoxyethoxy)ethanol,112-34-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7e3b982-395b-4ca3-afdc-80ed44f69f0c/documents/758865f4-03cf-4076-9d06-5f0b01d31692_679a9b61-3330-431d-a6e0-7aed365204b1.html,,oral,LD50,"2,410 mg/kg bw",adverse effect observed, 2-(2-butoxyethoxy)ethanol,112-34-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7e3b982-395b-4ca3-afdc-80ed44f69f0c/documents/758865f4-03cf-4076-9d06-5f0b01d31692_679a9b61-3330-431d-a6e0-7aed365204b1.html,,dermal,LD50,"2,764 mg/kg bw",adverse effect observed, 2-butoxyethanol,111-76-2, See tables in discussion section ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57c85aa7-f198-4012-9d0f-9dbcc25424e0/documents/IUC5-28649648-d050-4079-bfae-2406965932cb_6904173c-d8a4-49e9-afd0-47e025ee496e.html,,,,,, 2-butoxyethanol,111-76-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57c85aa7-f198-4012-9d0f-9dbcc25424e0/documents/IUC5-28649648-d050-4079-bfae-2406965932cb_6904173c-d8a4-49e9-afd0-47e025ee496e.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,69 mg/kg bw/day,, 2-butoxyethanol,111-76-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57c85aa7-f198-4012-9d0f-9dbcc25424e0/documents/IUC5-28649648-d050-4079-bfae-2406965932cb_6904173c-d8a4-49e9-afd0-47e025ee496e.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,152 mg/m3,, 2-butoxyethanol,111-76-2,"ORAL: Guinea pig: 1200, 1414mg/kg.  Average approx 1300mg/kg Rat LD50: 615 (female), 880 (male), 1480, 2420 (male), 2600 (male).  500-1500 (female), 1000-2000 (female)  Average: ~1400mg/kg. Mouse: 1230, 1519-2005.  Average approx 1500mg/kg Rabbit:  LD100<650mg/kg Dog: LD0>650mg/kg Human: LOAEL=400mg/kg INHALATION (Saturated vapour pressure estimated at 3.9mg/l, excluding unreliable data): Guinea pig: LC0 (4hr) >2.25mg/l, LC0 (1hr) >3.2-3.4mg/l, LC0(7hr)>400ppm (2mg/l), LC0(7hr)>400ppm (2mg/l), LC0(7hr)>400ppm (2mg/l) Rat: LC50  >3.9mg/l (4hr), 2.2-2.4mg/l (4hr) , >4.26mg/l (7hr). female (4hr) ~900ppm, male (7hr) >900ppm, >1.44mg/l(3hr) Dog: LC0(7hr)>400ppm (2mg/l), Dog: LC0(7hr)>400ppm (2mg/l), Dog: LC0(7hr)>400ppm (2mg/l) Rabbit LC50(7hr) ~ 400ppm (2mg/l) (based on an average of 3 replicates) DERMAL (excluding unreliable data) Guinea pig: 230-300, >1200 (possibly >2000), >2000mg/kg Rat: LD50>2000mg/kg (occlusive and semiocclusive conditions.) Rabbit: LD50 (mg/kg) = 435, 612, 405, 567, 841 (occlusive), >2000 (semiocclusive). Assessment based on choice of most appropriate species to represent toxicity to humans (guinea pig) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57c85aa7-f198-4012-9d0f-9dbcc25424e0/documents/65ef8c84-e5d5-40e7-8bb9-b1c1e952b66c_6904173c-d8a4-49e9-afd0-47e025ee496e.html,,,,,, 2-butoxyethanol,111-76-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57c85aa7-f198-4012-9d0f-9dbcc25424e0/documents/65ef8c84-e5d5-40e7-8bb9-b1c1e952b66c_6904173c-d8a4-49e9-afd0-47e025ee496e.html,,oral,LD50,"1,300 mg/kg bw",adverse effect observed, 2-butoxyethyl acetate,112-07-2, Oral route (surrogate substance with mol wt correction: LOAEL=94mg/kgbw/day. Dermal route (surrogate substance with mol wt correction: LOAEL=203mg/kgbw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de24b64f-b98d-49f8-a300-57fccec56ca5/documents/IUC5-7f2cd463-cb5e-40f0-8fc5-99731dbbd5f6_3987d44a-37e0-4859-9846-8132a2c55e62.html,,,,,, 2-butoxyethyl acetate,112-07-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de24b64f-b98d-49f8-a300-57fccec56ca5/documents/IUC5-7f2cd463-cb5e-40f0-8fc5-99731dbbd5f6_3987d44a-37e0-4859-9846-8132a2c55e62.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,94 mg/kg bw/day,, 2-butoxyethyl acetate,112-07-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de24b64f-b98d-49f8-a300-57fccec56ca5/documents/IUC5-7f2cd463-cb5e-40f0-8fc5-99731dbbd5f6_3987d44a-37e0-4859-9846-8132a2c55e62.html,Short-term repeated dose toxicity – systemic effects,dermal,LOAEL,203 mg/kg bw/day,, 2-butoxyethyl acetate,112-07-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de24b64f-b98d-49f8-a300-57fccec56ca5/documents/IUC5-7f2cd463-cb5e-40f0-8fc5-99731dbbd5f6_3987d44a-37e0-4859-9846-8132a2c55e62.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,206 mg/m3,, 2-butoxyethyl acetate,112-07-2," All available ORAL LD50 values Rat: 1600, 1880, 2400-3000, 7000 mg/kg Mouse: 2820 mg/kg Rabbit: 118-940mg/kg, ~987mg/kg Cat: >940mg/kg Reliable INHALATION LC50 values Rat: LC50(4hr)>2.66mg/l (SVC); LT50(SVC)=8hr, LC50(8hr)>SVC (3.91mg/l), LC0(3hr)>SVC (3.68mg/l) where SVC=saturated vapour concentration. All available DERMAL acute toxicity values: Rabbit LD50: 1580mg/kg (occlusive exposure) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de24b64f-b98d-49f8-a300-57fccec56ca5/documents/IUC5-4ac21ae6-cf40-49f2-979c-d8ac3fc37bb9_3987d44a-37e0-4859-9846-8132a2c55e62.html,,,,,, 2-butoxyethyl acetate,112-07-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de24b64f-b98d-49f8-a300-57fccec56ca5/documents/IUC5-4ac21ae6-cf40-49f2-979c-d8ac3fc37bb9_3987d44a-37e0-4859-9846-8132a2c55e62.html,,oral,LD50,"1,880 mg/kg bw",adverse effect observed, 2-butoxyethyl acetate,112-07-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de24b64f-b98d-49f8-a300-57fccec56ca5/documents/IUC5-4ac21ae6-cf40-49f2-979c-d8ac3fc37bb9_3987d44a-37e0-4859-9846-8132a2c55e62.html,,dermal,LD50,"1,500 mg/kg bw",adverse effect observed, Butyl O-acetylricinoleate,140-04-5, LD50 was estimated to be 4184 mg/kg bw when Sprague-Dawley male and female rats were orally exposed with butyl 12-acetoxyoctadec-9-enoate ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/743248fd-8a3d-4b52-98a8-388fa8429ee6/documents/b9c7cb4c-68ed-454b-b117-707819ad8657_83e56d02-227f-4c2d-969b-a758c39df66d.html,,,,,, Butyl O-acetylricinoleate,140-04-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/743248fd-8a3d-4b52-98a8-388fa8429ee6/documents/b9c7cb4c-68ed-454b-b117-707819ad8657_83e56d02-227f-4c2d-969b-a758c39df66d.html,,oral,LD50,"4,184 mg/kg bw",no adverse effect observed, Butyl acrylate,141-32-2," In a subchronic study in Sprague-Dawley rats following vapour inhalation for 13-weeks, the NOAEC was 570 mg/m3 (108 ppm). The respective LOAEC based on reduced body weight, clinico-chemical changes and changed organ weights was 1100 mg/m3 (211 ppm). Following chronic exposure by the inhalation route (5 d/w, 6 h/d), the NOAEC for ocular effects in rats was 258 mg/m3 (45 ppm); the LOAEC for local effects on the nasal epithelium was 86 mg/m3 (15 ppm). The systemic NOAEC was >= 773 mg/m3 (135 ppm). Following a 90-day oral administration of BA in the drinking water, the NOAEL was 84 (male) and 111 (female) mg/kg bw/d for F344 rats, respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/777d7570-4b43-457e-a7ba-01245085b8c7/documents/IUC5-defff7e1-ab8c-4499-8cc2-a2db78952d13_2817797c-05b2-48f3-8721-2831359fa4db.html,,,,,, Butyl acrylate,141-32-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/777d7570-4b43-457e-a7ba-01245085b8c7/documents/IUC5-defff7e1-ab8c-4499-8cc2-a2db78952d13_2817797c-05b2-48f3-8721-2831359fa4db.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,84 mg/kg bw/day,,rat Butyl acrylate,141-32-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/777d7570-4b43-457e-a7ba-01245085b8c7/documents/IUC5-defff7e1-ab8c-4499-8cc2-a2db78952d13_2817797c-05b2-48f3-8721-2831359fa4db.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,570 mg/m3,,rat Butyl acrylate,141-32-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/777d7570-4b43-457e-a7ba-01245085b8c7/documents/IUC5-defff7e1-ab8c-4499-8cc2-a2db78952d13_2817797c-05b2-48f3-8721-2831359fa4db.html,Repeated dose toxicity – local effects,inhalation,NOAEC,110 mg/m3,adverse effect observed,rat Butyl acrylate,141-32-2," Butyl acrylate is of low toxicity after a single ingestion and short term skin contact. Butyl acrylate is of moderate toxicity after short-term inhalation. Oral: LD50 = 3150 mg/kg bw (rat, BASF Test) Dermal: LD50: 2000 - 3024 mg/kg bw (rabbit, occlusive) Inhalation: LC50 = 10.3 mg/L (rat, OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/777d7570-4b43-457e-a7ba-01245085b8c7/documents/IUC5-a7f8c615-9698-49ce-bf7f-5d85931fcfad_2817797c-05b2-48f3-8721-2831359fa4db.html,,,,,, Butyl acrylate,141-32-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/777d7570-4b43-457e-a7ba-01245085b8c7/documents/IUC5-a7f8c615-9698-49ce-bf7f-5d85931fcfad_2817797c-05b2-48f3-8721-2831359fa4db.html,,oral,LD50,"3,150 mg/kg bw",no adverse effect observed, Butyl acrylate,141-32-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/777d7570-4b43-457e-a7ba-01245085b8c7/documents/IUC5-a7f8c615-9698-49ce-bf7f-5d85931fcfad_2817797c-05b2-48f3-8721-2831359fa4db.html,,dermal,discriminating dose,"2,000 mg/kg bw",adverse effect observed, Butyl acrylate,141-32-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/777d7570-4b43-457e-a7ba-01245085b8c7/documents/IUC5-a7f8c615-9698-49ce-bf7f-5d85931fcfad_2817797c-05b2-48f3-8721-2831359fa4db.html,,inhalation,LC50,"10,300 mg/m3",adverse effect observed, Butyl benzoate,136-60-7," Repeated dose toxicity - oral: A key K1 study in male and female Wistar rats in a combined repeated dose toxicity test with reproductive/developmental screening was conducted according to OECD 422 (Martell A., 2013). The NOAEL is established to be 1000 mg/kg body weight/day.   Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure.   Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f3eb89b-dc2a-4e4e-a469-fedc2dc4b500/documents/bb7786bb-1e45-45b7-baf3-e44a6ef582a9_b7b92940-5b4d-49c9-81da-5c0217d0a8ac.html,,,,,, Butyl benzoate,136-60-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f3eb89b-dc2a-4e4e-a469-fedc2dc4b500/documents/bb7786bb-1e45-45b7-baf3-e44a6ef582a9_b7b92940-5b4d-49c9-81da-5c0217d0a8ac.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Butyl benzoate,136-60-7," Acute toxicity - Oral: In an acute oral toxicity study in female Sprague-Dawley rats, following the up-and-down procedure in accordance with the OECD Guideline 425, the LD50 was established to be greater than 2000 mg/kg (Vasquez, 2012). Acute toxicity - Inhalation : In an acute inhalation toxicity study in male and female Wistar rats, following a method according to (US EPA) guidelines and OPPTS 870.1303, the LC50 was established to exceed 15.246 mg/L ( Ferreira, 2012). Acute toxicity - Dermal: In an acute dermal toxicity study in male and female Sprague-Dawley rats, following the standard acute method according to OECD Guideline 402 and EC method B.3, the LD50 was established to exceed 2000 mg/kg body weight (Vasquez, 2012). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f3eb89b-dc2a-4e4e-a469-fedc2dc4b500/documents/45e41407-53d0-4aa7-a726-c15c30b0d556_b7b92940-5b4d-49c9-81da-5c0217d0a8ac.html,,,,,, Butyl benzoate,136-60-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f3eb89b-dc2a-4e4e-a469-fedc2dc4b500/documents/45e41407-53d0-4aa7-a726-c15c30b0d556_b7b92940-5b4d-49c9-81da-5c0217d0a8ac.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Butyl benzoate,136-60-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f3eb89b-dc2a-4e4e-a469-fedc2dc4b500/documents/45e41407-53d0-4aa7-a726-c15c30b0d556_b7b92940-5b4d-49c9-81da-5c0217d0a8ac.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Butyl benzoate,136-60-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f3eb89b-dc2a-4e4e-a469-fedc2dc4b500/documents/45e41407-53d0-4aa7-a726-c15c30b0d556_b7b92940-5b4d-49c9-81da-5c0217d0a8ac.html,,inhalation,LC50,"15,246 mg/m3",no adverse effect observed, Benzyl butyl phthalate,85-68-7,"Acute toxicity tests with butyl benzyl phthalate in rats and mice (oral, up to 20 g/kg bw), rabbits (dermal, up to 10 g/kg bw), and rats (inhalation, saturated vapour) indicate that this compound does not need to be classified for acute toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8287daf5-8c0b-4af8-a1cd-8aa5542d792f/documents/IUC5-d574cb0a-d284-4608-ac7d-f5a8f7297f2e_c272ab59-01db-4f19-9b14-90675b5ecc1a.html,,,,,, Benzyl butyl phthalate,85-68-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8287daf5-8c0b-4af8-a1cd-8aa5542d792f/documents/IUC5-d574cb0a-d284-4608-ac7d-f5a8f7297f2e_c272ab59-01db-4f19-9b14-90675b5ecc1a.html,,oral,LD50,"2,330 mg/kg bw",, Butyl butyrate,109-21-7,"The test item is not to be considered acute toxic. The LD50 is 9518 mg/kg bw. Even though the study is not according to OECD or GLP, the result is reliable within a weight of evidence approach. With the dermal acute and intraperitoneal acute studies and the read-across data of ethyl hexanoate it is evident that the substance is not acute toxic. Even though the study is not according to OECD or GLP, the result is reliable and in support of the oral acute toxicity studies to strengthen that the substance is not acute toxic. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a02f53a-102b-4e2e-aa76-3ca57c467f26/documents/7681361f-53ce-4fbf-985f-e8ac18f060ca_b8c17e30-36a5-4593-a9e7-fe71b91bc48e.html,,,,,, Butyl butyrate,109-21-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a02f53a-102b-4e2e-aa76-3ca57c467f26/documents/7681361f-53ce-4fbf-985f-e8ac18f060ca_b8c17e30-36a5-4593-a9e7-fe71b91bc48e.html,,oral,LD50,"9,518 mg/kg bw",no adverse effect observed, Butyl butyrate,109-21-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a02f53a-102b-4e2e-aa76-3ca57c467f26/documents/7681361f-53ce-4fbf-985f-e8ac18f060ca_b8c17e30-36a5-4593-a9e7-fe71b91bc48e.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,2'-butyliminodiethanol",102-79-4,"Oral DBEA (CAS 102-81-8) - Oral, 90 d (OECD 408), rat: NOAEL = 50 mg/kg bw - Oral, 28 d (OECD 407), rat: NOEL = 50 mg/kg bw/d; NOAEL = 100 mg/kg bw/d; LOAEL = 400 mg/kg bw/d  - Oral, 5 weeks (OECD 407), rat: NOAEL (male) = 430 mg/kg bw/d; NOAEL (female) = 330mg/kg bw/d BEA (CAS 111-75-1) - Oral, 90 d (OECD 408), rat: NOAEL = 240 mg/kg bw/d (highest dose tested)- Oral, screening (OECD 422), rat: NOAEL (reproductive and developmental parameters; males and females) = 240 mg/kg bw/d (highest dose tested), NOAEL (systemic; males) = 120 mg/kg bw/d, NOAEL (systemic; females) = 240 mg/kg bw/d   Inhalation DBEA (CAS 102-81-8) - Inhalative, screening (OECD 422), rat: NOAEC (reproductive and developmental parameters; males and females) = 236.3 mg/m³, NOAEC (systemic; males and females) = 236.3 mg/m³ (highest dose tested), NOAEC (local, males and females) = 20.6 mg/m³ - inhalative, 6 month, rat: NOAEC = 156 mg/m³ (males) - inhalative, 5 days, rat: NOAEC = 234 mg/m³  (= 33 ppm); LOAEC = 495 mg/m³  (=70 ppm)   Dermal no study available Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): GLP guideline study on a structurally similar chemical. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): GLP guideline study on a structurally similar chemical. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP guideline study (Klimisch 1). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e32d14b-8f6a-4360-b12c-9a72dfdfada7/documents/IUC5-a677b02a-4726-495d-bd83-2b55bebda487_dd7c93f8-984b-4a04-a7b7-715a38c5ec2e.html,,,,,, "2,2'-butyliminodiethanol",102-79-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e32d14b-8f6a-4360-b12c-9a72dfdfada7/documents/IUC5-a677b02a-4726-495d-bd83-2b55bebda487_dd7c93f8-984b-4a04-a7b7-715a38c5ec2e.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,236.3 mg/m3,,rat "2,2'-butyliminodiethanol",102-79-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e32d14b-8f6a-4360-b12c-9a72dfdfada7/documents/IUC5-a677b02a-4726-495d-bd83-2b55bebda487_dd7c93f8-984b-4a04-a7b7-715a38c5ec2e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "2,2'-butyliminodiethanol",102-79-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e32d14b-8f6a-4360-b12c-9a72dfdfada7/documents/IUC5-a677b02a-4726-495d-bd83-2b55bebda487_dd7c93f8-984b-4a04-a7b7-715a38c5ec2e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,20.6 mg/m3,adverse effect observed,rat "2,2'-butyliminodiethanol",102-79-4," - Acute toxicity oral: similar to OECD 401, rats, dose levels: 190, 1900, 3100, 3900, 4850 and 6200 mg/kg bw. LD50 is ca. 4800 mg/kg bw(m/f); - Acute toxicity inhalation: data waiving due to low vapour pressure and absence of mortality in acute inhalation tests with the source substance BEA (CAS 111-75-1) and DBEA (102-81-8); - Acute toxicity dermal: GLP, OECD 402, Wistar rats, Dose level: 2000 mg/kg bw; no effects, slight skin reactions; LD50 > 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e32d14b-8f6a-4360-b12c-9a72dfdfada7/documents/IUC5-cb037d34-a6c4-4f1f-be9e-e88ac002e948_dd7c93f8-984b-4a04-a7b7-715a38c5ec2e.html,,,,,, "2,2'-butyliminodiethanol",102-79-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e32d14b-8f6a-4360-b12c-9a72dfdfada7/documents/IUC5-cb037d34-a6c4-4f1f-be9e-e88ac002e948_dd7c93f8-984b-4a04-a7b7-715a38c5ec2e.html,,oral,LD50,"4,800 mg/kg bw",no adverse effect observed, 2-butyl-2-ethylpropanediol,115-84-4,28-day and 90-day oral (gavage) toxicity studies in the rat are available.   ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4da285da-464e-4f4d-95a9-e313f497e04d/documents/IUC5-32dfd1ce-ccf2-4e66-8262-fdee1cff394b_35a11b49-9367-47de-9878-ef16711686da.html,,,,,, 2-butyl-2-ethylpropanediol,115-84-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4da285da-464e-4f4d-95a9-e313f497e04d/documents/IUC5-32dfd1ce-ccf2-4e66-8262-fdee1cff394b_35a11b49-9367-47de-9878-ef16711686da.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat 2-butyl-2-ethylpropanediol,115-84-4,Studies of acute oral and acute dermal toxicity are available for BEPD. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4da285da-464e-4f4d-95a9-e313f497e04d/documents/IUC5-fb94a4eb-2fc7-43bc-b675-27c5ee097abc_35a11b49-9367-47de-9878-ef16711686da.html,,,,,, 2-butyl-2-ethylpropanediol,115-84-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4da285da-464e-4f4d-95a9-e313f497e04d/documents/IUC5-fb94a4eb-2fc7-43bc-b675-27c5ee097abc_35a11b49-9367-47de-9878-ef16711686da.html,,oral,LD50,"2,900 mg/kg bw",no adverse effect observed, 2-butyl-2-ethylpropanediol,115-84-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4da285da-464e-4f4d-95a9-e313f497e04d/documents/IUC5-fb94a4eb-2fc7-43bc-b675-27c5ee097abc_35a11b49-9367-47de-9878-ef16711686da.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Butyl glycollate,7397-62-8, Animal data demonstrate that butyl glycollate (Polysolvan O) induced only very mild and reversible functional effects. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa4703d5-ffdb-4f52-bb63-0d08002ecfbf/documents/IUC5-1e11f132-52c7-4c74-9e53-823e68664d1a_62043995-2db5-47c9-9c82-394e59357766.html,,,,,, Butyl glycollate,7397-62-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa4703d5-ffdb-4f52-bb63-0d08002ecfbf/documents/IUC5-1e11f132-52c7-4c74-9e53-823e68664d1a_62043995-2db5-47c9-9c82-394e59357766.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Butyl glycollate,7397-62-8, The acute oral toxicity is very low and the key LD50 value in rats was 4595 mg/kg bw. The acute inhalation toxicity in rats is also very low. The ALC in rats was greater than 6.2 mg/L/4h. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa4703d5-ffdb-4f52-bb63-0d08002ecfbf/documents/IUC5-1c87835f-862a-451c-aa74-6c04f9c0f981_62043995-2db5-47c9-9c82-394e59357766.html,,,,,, Butyl glycollate,7397-62-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa4703d5-ffdb-4f52-bb63-0d08002ecfbf/documents/IUC5-1c87835f-862a-451c-aa74-6c04f9c0f981_62043995-2db5-47c9-9c82-394e59357766.html,,oral,LD50,"4,595 mg/kg bw",, Butyl 3-hydroxybutyrate,53605-94-0,"No lethality was observed following acute exposure to either n-butyl-3-hydroxybutyrate or the related ester alcohol, isopropyl-3-hydroxybutyrate, by either oral, dermal or inhalation. Dosages were administered up to a limiting concentration of 5000 mg/kg via oral or dermal administration, and up to 5.11 mg/L (mist/aerosol) via inhalation exposure. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f57b2202-4552-419e-9f37-3c482f359f0e/documents/IUC5-cac55042-7d6f-4ca0-8a6d-284555c1fc6d_b1f82ff3-423a-4d85-ac96-254bdc7b61f3.html,,,,,, 4-Hydroxy-cyclohexanecarboxylic acid butyl ester,1384257-92-4," No test for acute oral toxicity is available for 4 -hydroxycyclohexanecarboxylic acid butyl ester. However, an oral LD50 value of 3962 mg/kg bw in the rat is available for a structurally similar compound. (Q)SAR analysis revealed that the target compound as well as the source compound will result in the same metabolite after absorption. In addition 2 further structurally very similar compounds have been tested with LD50 values of more than 3000 mg/kg bw/day. Therefore, based on this read-across, it can be concluded that the oral LD50 value of 4 -hydroxycyclohexanecarboxylic acid butyl ester is in the range of 3962 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48fa4ded-f06b-47a9-a4b7-12b734f50bb1/documents/2fb65b3a-6980-455a-8560-ad072cac4e31_3087d6f7-a827-4231-9922-53d2b58de1a6.html,,,,,, 4-Hydroxy-cyclohexanecarboxylic acid butyl ester,1384257-92-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48fa4ded-f06b-47a9-a4b7-12b734f50bb1/documents/2fb65b3a-6980-455a-8560-ad072cac4e31_3087d6f7-a827-4231-9922-53d2b58de1a6.html,,oral,LD50,"3,962 mg/kg bw",no adverse effect observed, N-butyl 4-oxopentanoate,2052-15-5,"NOAEL (90 d, rats, f/m, Similar Substance 01) = 1000 mg/kg body weight/day.NOEL (90 d, rats, f/m, Similar Substance 03) = 125 mg/kg body weight/day.LOEL (90 d, rats, f/m, Similar Substance 03) = 500 mg/kg body weight/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c18b6d18-9ac6-4796-9217-e8da565cf345/documents/f4b22c04-3381-43b3-bdb5-db36e5ead135_fd5e8898-949b-4504-8b33-1acfd74e8589.html,,,,,, N-butyl 4-oxopentanoate,2052-15-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c18b6d18-9ac6-4796-9217-e8da565cf345/documents/f4b22c04-3381-43b3-bdb5-db36e5ead135_fd5e8898-949b-4504-8b33-1acfd74e8589.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat N-butyl 4-oxopentanoate,2052-15-5,"LD50 (oral) > 2000 mg/kg bw (rat, female) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c18b6d18-9ac6-4796-9217-e8da565cf345/documents/bfa7d616-d6f7-4ddb-9c44-cfc9377c05a7_fd5e8898-949b-4504-8b33-1acfd74e8589.html,,,,,, N-butyl 4-oxopentanoate,2052-15-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c18b6d18-9ac6-4796-9217-e8da565cf345/documents/bfa7d616-d6f7-4ddb-9c44-cfc9377c05a7_fd5e8898-949b-4504-8b33-1acfd74e8589.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Butyl hydrogen maleate,925-21-3," The oral administration of Butyl Hydrogen Maleate to rats by gavage, at dose levels of 175, 100 and 30 mg/kg bw/day, resulted in treatment-related changes at all dose levels. A ‘No Observed Effect Level’ (NOEL) for systemic toxicity could therefore not be established. The effects detected at 100 and 30 were considered not to represent an adverse effect, therefore the ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was considered to be 100 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07e1b8eb-91ec-48d8-9ab6-ca8c4d7f686d/documents/IUC5-6d905e1e-bff7-46be-b828-0f4e1f3fe3e4_bfc46389-5f59-4388-8d97-fb15e76b4451.html,,,,,, Butyl hydrogen maleate,925-21-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07e1b8eb-91ec-48d8-9ab6-ca8c4d7f686d/documents/IUC5-6d905e1e-bff7-46be-b828-0f4e1f3fe3e4_bfc46389-5f59-4388-8d97-fb15e76b4451.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Butyl hydrogen maleate,925-21-3,No studies to assess the acute toxicity of the test material were carried out as an in vitro skin irritation study concluded that the test material should be considered to be corrosive to skin. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07e1b8eb-91ec-48d8-9ab6-ca8c4d7f686d/documents/IUC5-eb30e495-d94b-4ed4-98f1-4c2bb0ff0704_bfc46389-5f59-4388-8d97-fb15e76b4451.html,,,,,, Butyl methacrylate,97-88-1,"Oral OECD 408, GLP, 90d, rat: NOAEL systemic 120 mg/kg bw/d (BASF, 2009) Inhalation chronic, rat: NOAEC local 60 ppm/ ca. 355 mg/m³ (olfactory epithelium of the URT); NOAEC systemic 500 ppm/ ca. 2955 mg/m3 (body weight effects); NOEC systemic 60 ppm/ ca. 355 mg/m³  (hematology & kidneys/ liver weight; based on a Weight-of-Evidence assessment 2023 using on 7 inhalation studies with nBMA and metabolites) Dermal No relevant data available ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d689ba83-806c-4b74-b197-13f5bd6601e8/documents/IUC5-1d3dced9-b9aa-44c8-9774-230c5911ba5d_d434e783-79a8-472f-b05d-0f9e925365dd.html,,,,,, Butyl methacrylate,97-88-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d689ba83-806c-4b74-b197-13f5bd6601e8/documents/IUC5-1d3dced9-b9aa-44c8-9774-230c5911ba5d_d434e783-79a8-472f-b05d-0f9e925365dd.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"11,175 mg/m3",,rat Butyl methacrylate,97-88-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d689ba83-806c-4b74-b197-13f5bd6601e8/documents/IUC5-1d3dced9-b9aa-44c8-9774-230c5911ba5d_d434e783-79a8-472f-b05d-0f9e925365dd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat Butyl methacrylate,97-88-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d689ba83-806c-4b74-b197-13f5bd6601e8/documents/IUC5-1d3dced9-b9aa-44c8-9774-230c5911ba5d_d434e783-79a8-472f-b05d-0f9e925365dd.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,500 ,, Butyl methacrylate,97-88-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d689ba83-806c-4b74-b197-13f5bd6601e8/documents/IUC5-1d3dced9-b9aa-44c8-9774-230c5911ba5d_d434e783-79a8-472f-b05d-0f9e925365dd.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,832 mg/m3",adverse effect observed,rat Butyl methacrylate,97-88-1,"LD 50 (oral) rat: > 2000 mg/kg / LD 0 (oral) rat: > 2000 mg/kg LD 50 (dermal) rabbit: > 2000 mg/kg / LD 0 (dermal) rabbit: > 2000 mg/kg LC0 (inhal). (4h) rat: ca. 27 mg/L (vapor/aerosol); approx lethal conc. (4h), rat: ca. 29 mg/L (vapor/aerosol)   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d689ba83-806c-4b74-b197-13f5bd6601e8/documents/IUC5-55ca30cd-26f1-45d1-a99b-c55f34153948_d434e783-79a8-472f-b05d-0f9e925365dd.html,,,,,, Butyl methacrylate,97-88-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d689ba83-806c-4b74-b197-13f5bd6601e8/documents/IUC5-55ca30cd-26f1-45d1-a99b-c55f34153948_d434e783-79a8-472f-b05d-0f9e925365dd.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Butyl methacrylate,97-88-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d689ba83-806c-4b74-b197-13f5bd6601e8/documents/IUC5-55ca30cd-26f1-45d1-a99b-c55f34153948_d434e783-79a8-472f-b05d-0f9e925365dd.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Butyl methacrylate,97-88-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d689ba83-806c-4b74-b197-13f5bd6601e8/documents/IUC5-55ca30cd-26f1-45d1-a99b-c55f34153948_d434e783-79a8-472f-b05d-0f9e925365dd.html,,inhalation,LC0,"27,000 mg/m3",no adverse effect observed, "1-[4-(1,1-dimethylethyl)phenyl]-3-(4-methoxyphenyl)propane-1,3-dione",70356-09-1," A sub-chronic oral toxicity study (90-day) revealed a NOAEL of 450 mg/kg bw/day, and a LOAEL of 1000 mg/kg bw/day. In one dermal repeated dose toxicity study (21 days) a NOAEL of 360 mg/kg bw/day (highest concentration tested) was obtained with the rabbit. Applying route to route extrapolation, by assuming that penetration of BMDBM through skin is equal to penetration through the intestinal wall, the same effect levels as for oral route shall apply for the dermal route of exposure. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ea895dd-fd50-4708-99a4-c8727b87e086/documents/IUC5-29f53be7-efeb-4b43-b83a-b0415da34653_0d113436-a33b-4793-b7ff-5aa1c5f87371.html,,,,,, "1-[4-(1,1-dimethylethyl)phenyl]-3-(4-methoxyphenyl)propane-1,3-dione",70356-09-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ea895dd-fd50-4708-99a4-c8727b87e086/documents/IUC5-29f53be7-efeb-4b43-b83a-b0415da34653_0d113436-a33b-4793-b7ff-5aa1c5f87371.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,360 mg/kg bw/day,,rat "1-[4-(1,1-dimethylethyl)phenyl]-3-(4-methoxyphenyl)propane-1,3-dione",70356-09-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ea895dd-fd50-4708-99a4-c8727b87e086/documents/IUC5-29f53be7-efeb-4b43-b83a-b0415da34653_0d113436-a33b-4793-b7ff-5aa1c5f87371.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat "1-[4-(1,1-dimethylethyl)phenyl]-3-(4-methoxyphenyl)propane-1,3-dione",70356-09-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ea895dd-fd50-4708-99a4-c8727b87e086/documents/IUC5-29f53be7-efeb-4b43-b83a-b0415da34653_0d113436-a33b-4793-b7ff-5aa1c5f87371.html,Repeated dose toxicity – local effects,dermal,NOAEL,6.6 mg/cm2,adverse effect observed,rabbit "1-[4-(1,1-dimethylethyl)phenyl]-3-(4-methoxyphenyl)propane-1,3-dione",70356-09-1, In an acute oral toxicity study with the rat the LD50 of BMDBM was greater than 16000 mg/kg bw . No dermal toxicity effects up to the maximum applied dose of 1000 mg/kg bw were observed in an acute dermal toxicity study with the rat. No study on inhalation toxicity of BMDBM is available. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ea895dd-fd50-4708-99a4-c8727b87e086/documents/IUC5-c2e904e0-af39-4c4f-9239-6298f209ed7c_0d113436-a33b-4793-b7ff-5aa1c5f87371.html,,,,,, Butyl propionate,590-01-2,"There is a GLP 90-day repeated dose inhalation study in rats available for butyl propionate however no repeated oral or dermal dose studies are available. In addition, there are other repeated dose inhalation studies ranging up to 28 days in duration for the other substances in the category, n-propyl propionate and pentyl propionate refer to the justification for read across attached to section 13 of the dataset). The only common finding across all the studies has been histopathologic changes in the nasal tissues (olfactory epithelium damage) and this can be considered to be a local effect, while again across all the studies there have been no major indications of any systemic toxicity up to the highest doses tested. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e70bc12a-326d-443b-aa07-162c560aeff7/documents/3cb42d73-6588-46b7-b280-6be08d2b254f_fe5b32a0-e6bc-4b59-8ec9-04b113d61837.html,,,,,, Butyl propionate,590-01-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e70bc12a-326d-443b-aa07-162c560aeff7/documents/3cb42d73-6588-46b7-b280-6be08d2b254f_fe5b32a0-e6bc-4b59-8ec9-04b113d61837.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,300 mg/m3",adverse effect observed,rat Butyl propionate,590-01-2,"Acute oral - In a non-GLP study conducted with study methodology equivalent to OECD TG 401, the LD50 value of butyl propionate to male and female Sprague Dawley rats was > 14 ml/kg (Conversion from ml/kg to mg/kg resulted in - 14.1 ml/kg - 12345 mg/kg (based on density of 0.87)).Acute dermal - In a non-GLP study conducted with study methodology equivalent to OECD TG 402, the acute dermal LD50 value of butyl propionate to male and female New Zealand rabbits was > 16 ml/kg (Conversion from ml/kg to mg/kg resulted in - 16 ml/kg - 14008 mg/kg (based on density of 0.87)). Acute inhalation - In a non-GLP study conducted with study methodology equivalent to OECD TG 403, the acute inhalation LC50 value of butyl propionate to male and female Sprague Dawley rats exposed to saturated vapors over a period of 6 hours was 10070 mg/m3 or 10.07 mg/l (based on conversion). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e70bc12a-326d-443b-aa07-162c560aeff7/documents/befc4ea0-22db-46eb-8337-73de685cb8b4_fe5b32a0-e6bc-4b59-8ec9-04b113d61837.html,,,,,, "6-tert-butyl-2,4-xylenol",1879-09-0," Key value determined in compliance wiith GLP and analytical verification performed, however no reference guidelines detailed in the report. 3month NOAEL 100 ppm in the rat. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48f9460b-e950-4c63-a2d0-172fc7024d2b/documents/IUC5-e0df2555-cf92-4126-888b-fc274a5576ed_908be161-c453-47f4-9806-eabfaf7094f3.html,,,,,, "6-tert-butyl-2,4-xylenol",1879-09-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48f9460b-e950-4c63-a2d0-172fc7024d2b/documents/IUC5-e0df2555-cf92-4126-888b-fc274a5576ed_908be161-c453-47f4-9806-eabfaf7094f3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,6 mg/kg bw/day,,rat "6-tert-butyl-2,4-xylenol",1879-09-0, Acute toxic effects are noted. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48f9460b-e950-4c63-a2d0-172fc7024d2b/documents/IUC5-b3ac1ece-7673-448f-ab55-6c8c574ad734_908be161-c453-47f4-9806-eabfaf7094f3.html,,,,,, "6-tert-butyl-2,4-xylenol",1879-09-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48f9460b-e950-4c63-a2d0-172fc7024d2b/documents/IUC5-b3ac1ece-7673-448f-ab55-6c8c574ad734_908be161-c453-47f4-9806-eabfaf7094f3.html,,oral,LD50,910 mg/kg bw,adverse effect observed, "6-tert-butyl-2,4-xylenol",1879-09-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48f9460b-e950-4c63-a2d0-172fc7024d2b/documents/IUC5-b3ac1ece-7673-448f-ab55-6c8c574ad734_908be161-c453-47f4-9806-eabfaf7094f3.html,,dermal,LD50,50 mg/kg bw,adverse effect observed, "Butane-1,3-diol",107-88-0,"No toxic effects were observed in a 2-year feeding study in rats receiving up to 5000 mg 1,3-butylene glycol/kg bw /d (Celanese, 1963a, Scala and Paynter, 1967) and in a chronic feeding study in dogs receiving up to 750 mg 1,3-butylene glycol/kg bw /d (Celanese, 1963b, Scala and Paynter, 1967). In a subchronic feeding study in dogs the NOAEL was 6000 mg/kg bw and day and the LOAEL 9000 mg/kg bw and day (Reuzel et al., 1978). Effectcs at the LOAEL were changes in behaviour, haematology, blood biochemistry, organ weights and growth rate. These data are supported by additional studies in rats and dogs of less reliability (Kopf et al., 1950; Smyth et al., 1951).No adverse effects were observed in a non-reliable dermal study in rats which were exposed for 4 or 14 days to 20100 mg 1,3-butylene glycol/kg bw/d (Kopf et al., 1950). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d8aa59f-e967-4d87-be0b-92cf22072f72/documents/IUC5-ec206a9e-4bba-4048-b4e2-9b28c4c712e3_7bd6e86f-d3d3-4a57-b3ea-9392bb094f54.html,,,,,, "Butane-1,3-diol",107-88-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d8aa59f-e967-4d87-be0b-92cf22072f72/documents/IUC5-ec206a9e-4bba-4048-b4e2-9b28c4c712e3_7bd6e86f-d3d3-4a57-b3ea-9392bb094f54.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"20,100 mg/kg bw/day",,guinea pig "Butane-1,3-diol",107-88-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d8aa59f-e967-4d87-be0b-92cf22072f72/documents/IUC5-ec206a9e-4bba-4048-b4e2-9b28c4c712e3_7bd6e86f-d3d3-4a57-b3ea-9392bb094f54.html,Chronic toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat "Butane-1,3-diol",107-88-0,"The acute toxicity of the test substance is low. This is based on oral LD50 values > 10000 mg/kg bw in several species, no lethal effects in the rat at 8 h exposure to saturated vapour concentration and a dermal LD50 > 20000 mg/kg bw as well as a low toxicity after parenteral application. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d8aa59f-e967-4d87-be0b-92cf22072f72/documents/IUC5-9b32f5d5-5750-41b7-ae28-7ee96922890a_7bd6e86f-d3d3-4a57-b3ea-9392bb094f54.html,,,,,, "Butane-1,3-diol",107-88-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d8aa59f-e967-4d87-be0b-92cf22072f72/documents/IUC5-9b32f5d5-5750-41b7-ae28-7ee96922890a_7bd6e86f-d3d3-4a57-b3ea-9392bb094f54.html,,oral,LD50,"22,800 mg/kg bw",no adverse effect observed, "Butane-1,3-diol",107-88-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d8aa59f-e967-4d87-be0b-92cf22072f72/documents/IUC5-9b32f5d5-5750-41b7-ae28-7ee96922890a_7bd6e86f-d3d3-4a57-b3ea-9392bb094f54.html,,inhalation,discriminating conc.,292 mg/m3,no adverse effect observed, "(R)-(-)-butane-1,3-diol",6290-03-5," Rats received 1,3-butylene glycol in the diet at levels of 1.0, 3.0, and 10%, for two years (500, 1500 and 5000 mg/kg/d). The control group was fed the basal laboratory diet. The physical appearance and behavior of the test rats generally was comparable with those of the corresponding controls. Organ weights and ratios were comparable with the controls. None of the test rats showed any sign of compound related effect.   Dogs received 1,3-butylene glycol in the diet at levels of 0.5, 1.0, and 3.0%, for two years (125, 250 and 750 mg/kg/d). The control group was fed the basal laboratory diet. The physical appearance and behavior of the test dogs generally was comparable with those of the corresponding controls. Organ weights and ratios were comparable with the controls. None of the test dogs showed any sign of compound related effect.   Values generated on the source substance will represent a very similar or slightly worse case than the target substance.  Therefore, it is predicted that the target substance (R)-(-)-1,3-butanediol will be without deleterious effect at the highest levels fed to experimental animals, namely, 10% (5000 mg/kg/d) in the diet of rats and 3% (750 mg/kg/d) in the diet of dogs. HYPOTHESIS FOR THE ANALOGUE APPROACH Data for butane-1,3-diol (CAS No. 107-88-0) was used to address the toxicological data requirements for (R)-(-)-butane-1,3-diol (CAS No. 6290-03-5) in an analogue read-across approach. The basis for this read-across approach is the extreme structural similarity of the source and target substances, in that the source substance is a racemic mixture of a pair of enantiomers, whereas the target substance is solely the R-enantiomer of that source pair. Two compounds that are enantiomers of each other have the same physical properties, except for the direction in which they rotate polarized light and how they interact with different optical isomers of other compounds (ECHA, 2008). Passive absorption of a substance into a test species and distribution through its tissues are governed by the physical-chemical properties of the substance, particularly its molecular size, log P, and water solubility (ECHA, 2014), and are therefore expected to be exactly the same for both enantiomers. The R-enantiomer half of the source substance and all of the target substance have been shown to metabolise in a mammalian system to a physiological ketone body, whereas the S-enantiomer of that ketone body derived from the other half of the source substance has been shown to metabolise into a compound that is not naturally present, but which can still be utilized by a less direct pathway (Desrochers et al., 1992). On the premise that a less direct metabolic pathway must be more energy-expensive, and therefore may be more likely to perturb the system and potentially produce an adverse effect, toxicity data on the source substance will represent a very similar or slightly worse case than, and provide a sound basis for a slightly conservative assessment of, the toxicity of the target substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2439e5c5-e187-40ec-b580-3d067c42c706/documents/b42e6af6-7ece-4970-ba2d-29234f518334_c996949f-c4fe-4198-8d31-4fafd1f72502.html,,,,,, "(R)-(-)-butane-1,3-diol",6290-03-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2439e5c5-e187-40ec-b580-3d067c42c706/documents/b42e6af6-7ece-4970-ba2d-29234f518334_c996949f-c4fe-4198-8d31-4fafd1f72502.html,Chronic toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat "(R)-(-)-butane-1,3-diol",6290-03-5," The acute oral toxicity data generated on the source substance [(R/S)-butane-1,3-diol (203-529-7; 107-88-0)] will represent a very similar or slightly worse case than the target substance [(R)-(-)-Butane-1,3-diol]. Non-fasted rats were given single oral doses. The LD50 (observation period: 14 days) of (R/S)-butane-1,3-diol was 22800 mg/kg bw. The acute oral toxicity of (R)-(-)-Butane-1,3-diol is predicted to be LD50 of approximately 22800 mg/kg bw.   The acute inhalation toxicity data generated on the source substance [(R/S)-butane-1,3-diol (203-529-7; 107-88-0)] will represent a very similar or slightly worse case than the target substance [(R)-(-)-Butane-1,3-diol]. No lethal effects were observed in rats after a single 8-hours exposure to a (R/S)-butane-1,3-diol saturated vapour. The acute inhalation toxicity of (R)-(-)-Butane-1,3-diol is predicted to be 8-hour LC50 greater than the saturated vapour concentration.   The work of this group pre-dates range finding toxicity guidelines and provided much of the basis for their development. Their results are cited by many subsequent authoritative review bodies and are often found in SIDS and SIAR documents via secondary references. Therefore, these results are deemed reliable.   Testing by the dermal route does not need to be conducted as the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects after dermal exposure are predicted on the basis of non-testing approaches (e.g. read-across). HYPOTHESIS FOR THE ANALOGUE APPROACH Data for butane-1,3-diol (CAS No. 107-88-0) was used to address the toxicological data requirements for (R)-(-)-butane-1,3-diol (CAS No. 6290-03-5) in an analogue read-across approach. The basis for this read-across approach is the extreme structural similarity of the source and target substances, in that the source substance is a racemic mixture of a pair of enantiomers, whereas the target substance is solely the R-enantiomer of that source pair. Two compounds that are enantiomers of each other have the same physical properties, except for the direction in which they rotate polarized light and how they interact with different optical isomers of other compounds (ECHA, 2008). Passive absorption of a substance into a test species and distribution through its tissues are governed by the physical-chemical properties of the substance, particularly its molecular size, log P, and water solubility (ECHA, 2014), and are therefore expected to be exactly the same for both enantiomers. The R-enantiomer half of the source substance and all of the target substance have been shown to metabolise in a mammalian system to a physiological ketone body, whereas the S-enantiomer of that ketone body derived from the other half of the source substance has been shown to metabolise into a compound that is not naturally present, but which can still be utilized by a less direct pathway (Desrochers et al., 1992). On the premise that a less direct metabolic pathway must be more energy-expensive, and therefore may be more likely to perturb the system and potentially produce an adverse effect, toxicity data on the source substance will represent a very similar or slightly worse case than, and provide a sound basis for a slightly conservative assessment of, the toxicity of the target substance. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2439e5c5-e187-40ec-b580-3d067c42c706/documents/b2a57516-238c-4ed2-a5c7-940161f3ab8a_c996949f-c4fe-4198-8d31-4fafd1f72502.html,,,,,, "(R)-(-)-butane-1,3-diol",6290-03-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2439e5c5-e187-40ec-b580-3d067c42c706/documents/b2a57516-238c-4ed2-a5c7-940161f3ab8a_c996949f-c4fe-4198-8d31-4fafd1f72502.html,,oral,LD50,"22,800 mg/kg bw",no adverse effect observed, 2-butylaminoethanol,111-75-1," The substance N-butylethanolamine (BEA) did not induce mortalities and clinical signs in treated animals in a 90 day oral repeated dose toxicity study. Furthermore, BEA was shown not to induce reprotoxic or developmental toxicity in an oral OECD 422 study in rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67a90590-c3b4-418f-a6c0-ef946cf18961/documents/IUC5-ee39db93-20cb-4869-8a67-b51ec7516036_2f8d2e8a-f5f9-4483-8aea-30d5bed3ce0f.html,,,,,, 2-butylaminoethanol,111-75-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67a90590-c3b4-418f-a6c0-ef946cf18961/documents/IUC5-ee39db93-20cb-4869-8a67-b51ec7516036_2f8d2e8a-f5f9-4483-8aea-30d5bed3ce0f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,240 mg/kg bw/day,,rat 2-butylaminoethanol,111-75-1,"Acute Toxicity:- oral: LD50: 892 - 1310 mg/kg bw mg/kg bw (rat; BASF, 1977)- dermal: LD0 of > 2000 mg/kg bw (Latven, 1977)- inhalation: IHT - no mortality (rat, BASF XXVI/45, 1977) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67a90590-c3b4-418f-a6c0-ef946cf18961/documents/IUC5-a489462a-868e-4794-a93d-a5172a0230b1_2f8d2e8a-f5f9-4483-8aea-30d5bed3ce0f.html,,,,,, 2-butylaminoethanol,111-75-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67a90590-c3b4-418f-a6c0-ef946cf18961/documents/IUC5-a489462a-868e-4794-a93d-a5172a0230b1_2f8d2e8a-f5f9-4483-8aea-30d5bed3ce0f.html,,oral,LD50,892 mg/kg bw,adverse effect observed, 2-butylaminoethanol,111-75-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67a90590-c3b4-418f-a6c0-ef946cf18961/documents/IUC5-a489462a-868e-4794-a93d-a5172a0230b1_2f8d2e8a-f5f9-4483-8aea-30d5bed3ce0f.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-butyloctanoic acid,27610-92-0,"On the basis of this combined repeated dose oral toxicity and reproduction/ developmental toxicity screening test according to OECD guideline 422 with the test item 2-butyloctanoic acid in male and female Wistar rats with dose levels of 100, 250, and 500 mg/kg bw/day the following conclusions can be made: The NOAEL (No Observed Adverse Effect Level) for male animals is considered to be at 500 mg/kg bw/day. Considering the severe toxicity in the dose range finding study (BSL study number 2100408) at 600 and 1000 mg/kg bw/day and the post-natal effects in females treated at 500 mg/kg bw/day, the NOAEL for maternal toxicity is determined to be 250 mg/kg bw/day. 2-butyl octanoic acid seems to have a very steep dose-response relationship.  In the 28-Day Repeated Dose Oral Toxicity supporting study with the similar substance Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid, in male and female Wistar rats with dose levels of 50, 250, and 1000 mg/kg body weight day revealed no major toxicity or mortality. No mortality or signs of Reaction mass of 2-butylheptanoic acid and 2-ethylnonanoic acid and 2-methyldecanoic acid and 2-propyloctanoic acid were found at the dose level of 1000 mg/kg bw/day. Therefore, the NOAEL of the similar substance in this study is considered to be 1000 mg/kg bw/day. In the supporting study according to the OECD guideline 422 with the similar substance docosanoic acid a NOAEL of 1000 mg/kg bw/d was considered.    ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a92e5bf-b990-43ad-87b5-a86d6e87e1a7/documents/d9e16e2f-c15d-45fa-bc02-b842e0fad0ef_6f70829d-2b74-48c7-8f23-eb086b36409d.html,,,,,, 2-butyloctanoic acid,27610-92-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a92e5bf-b990-43ad-87b5-a86d6e87e1a7/documents/d9e16e2f-c15d-45fa-bc02-b842e0fad0ef_6f70829d-2b74-48c7-8f23-eb086b36409d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 2-butyloctanoic acid,27610-92-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a92e5bf-b990-43ad-87b5-a86d6e87e1a7/documents/IUC5-d80a6ff1-6241-4a5b-ab33-c070efc2c7ee_6f70829d-2b74-48c7-8f23-eb086b36409d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-butyloctanoic acid,27610-92-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a92e5bf-b990-43ad-87b5-a86d6e87e1a7/documents/IUC5-d80a6ff1-6241-4a5b-ab33-c070efc2c7ee_6f70829d-2b74-48c7-8f23-eb086b36409d.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-butyloctan-1-ol,3913-02-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4e30327-680d-473f-8c78-a8466efa5992/documents/0463c470-d0eb-4c84-af88-bb19561be0bf_0a7af5d7-ba6e-4f2d-87ce-d2e0c6b2f372.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,839.6 mg/kg bw/day,,rat 2-butyloctan-1-ol,3913-02-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4e30327-680d-473f-8c78-a8466efa5992/documents/IUC5-a9d96f38-4e5a-449c-b2fe-07576085c0e7_0a7af5d7-ba6e-4f2d-87ce-d2e0c6b2f372.html,,oral,LD50,"26,533 mg/kg bw",adverse effect observed, 2-butyloctan-1-ol,3913-02-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4e30327-680d-473f-8c78-a8466efa5992/documents/IUC5-a9d96f38-4e5a-449c-b2fe-07576085c0e7_0a7af5d7-ba6e-4f2d-87ce-d2e0c6b2f372.html,,dermal,discriminating dose,"1,674 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18, 2-butyloctyl esters",101227-08-1,subacute oral toxicity: NOAEL 1000 mg/kg bw/d of the source substance 2-Ethylhexylstearate ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/665942ce-f063-447c-84cf-25c22167223c/documents/IUC5-3752c870-b58d-4cf1-9ed8-527eea520830_cf5b37f4-7e92-472a-b026-6c969a1491f1.html,,,,,, "Fatty acids, C16-18, 2-butyloctyl esters",101227-08-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/665942ce-f063-447c-84cf-25c22167223c/documents/IUC5-3752c870-b58d-4cf1-9ed8-527eea520830_cf5b37f4-7e92-472a-b026-6c969a1491f1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C16-18, 2-butyloctyl esters",101227-08-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate, reliable (Klimisch score 1). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The available information comprises adequate, reliable (Klimisch score 2) and consistent studies, from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s) and common precursors/breakdown products (refer to endpoint discussion for further details). The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch 2 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/665942ce-f063-447c-84cf-25c22167223c/documents/IUC5-c6ea0fdf-8219-4dc3-b864-f9a1378d605b_cf5b37f4-7e92-472a-b026-6c969a1491f1.html,,,,,, "Fatty acids, C16-18, 2-butyloctyl esters",101227-08-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/665942ce-f063-447c-84cf-25c22167223c/documents/IUC5-c6ea0fdf-8219-4dc3-b864-f9a1378d605b_cf5b37f4-7e92-472a-b026-6c969a1491f1.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18, 2-butyloctyl esters",101227-08-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/665942ce-f063-447c-84cf-25c22167223c/documents/IUC5-c6ea0fdf-8219-4dc3-b864-f9a1378d605b_cf5b37f4-7e92-472a-b026-6c969a1491f1.html,,inhalation,discriminating conc.,"5,700 mg/m3",no adverse effect observed, butyl 4-hydroxybenzoate,94-26-8," A read-across approach was conducted on source substance isobutyl 4-hydroxybenzoate: Acute toxicity after single oral application was tested in female rats, which received 2000 mg/kg bw (two groups of three females). All animals survived until the end of the study.The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, prone position, moving the bedding, ataxia, hunched posture, piloerection and half eyelid closure. All symptoms recovered within 1 day post-dose. Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain. At necropsy, no macroscopic findings were observed in any animal of any step. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4782c790-fe96-4e20-a914-08d0c445e9c1/documents/c2d28249-89c1-450b-804e-22dbb9940d45_74ec969f-fc85-42fd-af36-2ab312f871a0.html,,,,,, butyl 4-hydroxybenzoate,94-26-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4782c790-fe96-4e20-a914-08d0c445e9c1/documents/c2d28249-89c1-450b-804e-22dbb9940d45_74ec969f-fc85-42fd-af36-2ab312f871a0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-(4-tert-butylbenzyl)propionaldehyde,80-54-6,"Key study repeated dose toxicity oral: 90 day rat oral (OECD TG 408, GLP) NOEL = 5 mg/kg bw/d ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f0c5904-cfce-4f52-91c7-295b3538e018/documents/IUC5-f5ed460d-5d09-4de1-8234-6c29a36b47d1_db9397fa-ff63-4bdf-8784-2384e26e3fb9.html,,,,,, 2-(4-tert-butylbenzyl)propionaldehyde,80-54-6,Key study for acute oral toxicity (rat): LD50 1390 mg/kgKey study for acute dermal toxicity (rat): LD50 >2000 mg/kgSupportive study for acute dermal toxicity (rabbit): LD50 >5000 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f0c5904-cfce-4f52-91c7-295b3538e018/documents/IUC5-3ca93dd2-6400-4d11-9c0d-210bcc79a0fb_db9397fa-ff63-4bdf-8784-2384e26e3fb9.html,,,,,, Butyraldehyde,123-72-8,"4 repeated dose toxicty (oral) studies are available and 9 repeated dose toxicity (inhalation) studies are available. The species used for conduction of these studies included rat, mouse, guinea pig, rabbit and dog. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89189da2-f333-4c69-b58f-3094652189c8/documents/a86fd6ac-4beb-461c-b48c-82f506fdf4e8_fa86f3c1-f70d-4624-949e-2c84967a8d2c.html,,,,,, Butyraldehyde,123-72-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89189da2-f333-4c69-b58f-3094652189c8/documents/a86fd6ac-4beb-461c-b48c-82f506fdf4e8_fa86f3c1-f70d-4624-949e-2c84967a8d2c.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,75 mg/kg bw/day,, Butyraldehyde,123-72-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89189da2-f333-4c69-b58f-3094652189c8/documents/a86fd6ac-4beb-461c-b48c-82f506fdf4e8_fa86f3c1-f70d-4624-949e-2c84967a8d2c.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,150 mg/m3,, Butyraldehyde,123-72-8,A large number of toxicity studies are available in various species. The results indicate that the substance is of relatively low toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89189da2-f333-4c69-b58f-3094652189c8/documents/7a6b1a9d-b92d-47bd-a459-d7d1c3908207_fa86f3c1-f70d-4624-949e-2c84967a8d2c.html,,,,,, Butyraldehyde,123-72-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89189da2-f333-4c69-b58f-3094652189c8/documents/7a6b1a9d-b92d-47bd-a459-d7d1c3908207_fa86f3c1-f70d-4624-949e-2c84967a8d2c.html,,oral,LD50,"5,890 mg/kg bw",no adverse effect observed, Butyraldehyde,123-72-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89189da2-f333-4c69-b58f-3094652189c8/documents/7a6b1a9d-b92d-47bd-a459-d7d1c3908207_fa86f3c1-f70d-4624-949e-2c84967a8d2c.html,,inhalation,LC50,"> 5,460 mg/L",no adverse effect observed, Butyric acid,107-92-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6627bbc-885d-4928-b2ba-260025e1ba1f/documents/b2a3f178-a699-433e-98cb-fd40e4ca9028_46780cde-70ab-43a8-a60a-df904c05b6f6.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,830 mg/m3",,rat Butyric acid,107-92-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6627bbc-885d-4928-b2ba-260025e1ba1f/documents/70ec8753-f2ca-4468-815b-d0b1342074f1_46780cde-70ab-43a8-a60a-df904c05b6f6.html,,oral,LD50,"1,632 mg/kg bw",adverse effect observed, Butyric acid,107-92-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6627bbc-885d-4928-b2ba-260025e1ba1f/documents/70ec8753-f2ca-4468-815b-d0b1342074f1_46780cde-70ab-43a8-a60a-df904c05b6f6.html,,dermal,LD50,"6,096 mg/kg bw",no adverse effect observed, Butyric acid,107-92-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6627bbc-885d-4928-b2ba-260025e1ba1f/documents/70ec8753-f2ca-4468-815b-d0b1342074f1_46780cde-70ab-43a8-a60a-df904c05b6f6.html,,inhalation,LC50,"5,100 mg/m3",no adverse effect observed, γ-butyrolactone,96-48-0,"90-Day NOAEL (Oral, rat): 225 mg/kg bw ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0aeb1911-4cab-48e7-abb2-a9e12a46ef80/documents/IUC5-1f08c280-eed3-446f-8eff-d576e1a53359_9ff88f2a-a167-459f-9ff2-86029c7495d8.html,,,,,, γ-butyrolactone,96-48-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0aeb1911-4cab-48e7-abb2-a9e12a46ef80/documents/IUC5-1f08c280-eed3-446f-8eff-d576e1a53359_9ff88f2a-a167-459f-9ff2-86029c7495d8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,225 mg/kg bw/day,, γ-butyrolactone,96-48-0,Oral LD50: 1582 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0aeb1911-4cab-48e7-abb2-a9e12a46ef80/documents/IUC5-07420054-c804-473c-abbb-bf07f12ac76c_9ff88f2a-a167-459f-9ff2-86029c7495d8.html,,,,,, γ-butyrolactone,96-48-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0aeb1911-4cab-48e7-abb2-a9e12a46ef80/documents/IUC5-07420054-c804-473c-abbb-bf07f12ac76c_9ff88f2a-a167-459f-9ff2-86029c7495d8.html,,oral,LD50,"1,582 mg/kg bw",, "Naphtha (petroleum), hydrotreated heavy",64742-48-9,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4962b07-6934-4efd-b313-7ae4441a27cb/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_bcfea1ee-6f29-411f-8abf-579b458ff1b9.html,,,,,, "Naphtha (petroleum), hydrotreated heavy",64742-48-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4962b07-6934-4efd-b313-7ae4441a27cb/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_bcfea1ee-6f29-411f-8abf-579b458ff1b9.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), hydrotreated heavy",64742-48-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4962b07-6934-4efd-b313-7ae4441a27cb/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_bcfea1ee-6f29-411f-8abf-579b458ff1b9.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), hydrotreated heavy",64742-48-9," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4962b07-6934-4efd-b313-7ae4441a27cb/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_bcfea1ee-6f29-411f-8abf-579b458ff1b9.html,,,,,, "Naphtha (petroleum), hydrotreated heavy",64742-48-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4962b07-6934-4efd-b313-7ae4441a27cb/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_bcfea1ee-6f29-411f-8abf-579b458ff1b9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), hydrotreated heavy",64742-48-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4962b07-6934-4efd-b313-7ae4441a27cb/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_bcfea1ee-6f29-411f-8abf-579b458ff1b9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), hydrotreated heavy",64742-48-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4962b07-6934-4efd-b313-7ae4441a27cb/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_bcfea1ee-6f29-411f-8abf-579b458ff1b9.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Hydrocarbons, C10-C13, n-alkanes",129813-66-7, Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test – NOAEL ≥ 1000 mg/kg for rats (OECD 422) Repeated Dose Oral 90d - NOAEL ≥ 5000 mg/kg bw/day for rats (OECD 408) Repeated Dose Inhalation 90d – NOAEC ≥ 10400 mg/m3 for rats (similar to OECD TG 413) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/997e1bec-8055-4109-b072-41e337a3969a/documents/38769453-8e27-4cb5-8ce7-8f3760b72798_f5c04a24-29d8-419f-8e00-7ddd3faca0f5.html,,,,,, "Hydrocarbons, C10-C13, n-alkanes",129813-66-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/997e1bec-8055-4109-b072-41e337a3969a/documents/38769453-8e27-4cb5-8ce7-8f3760b72798_f5c04a24-29d8-419f-8e00-7ddd3faca0f5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat "Hydrocarbons, C10-C13, n-alkanes",129813-66-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/997e1bec-8055-4109-b072-41e337a3969a/documents/38769453-8e27-4cb5-8ce7-8f3760b72798_f5c04a24-29d8-419f-8e00-7ddd3faca0f5.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"10,400 mg/m3",,rat "Hydrocarbons, C10-C13, n-alkanes",129813-66-7, Acute Toxicity-Oral LD50 > 15000 mg/kg in rats (OECD TG 401) Acute Toxicity-Inhalation LC50 > 6100 mg/m3 (OECD TG 403) Acute Toxicity-Dermal LD50 > 3160 mg/kg in rabbits (OECD TG 402) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/997e1bec-8055-4109-b072-41e337a3969a/documents/ae402ed2-c26d-461d-933f-ceaa7cd29529_f5c04a24-29d8-419f-8e00-7ddd3faca0f5.html,,,,,, "Hydrocarbons, C10-C13, n-alkanes",129813-66-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/997e1bec-8055-4109-b072-41e337a3969a/documents/ae402ed2-c26d-461d-933f-ceaa7cd29529_f5c04a24-29d8-419f-8e00-7ddd3faca0f5.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C10-C13, n-alkanes",129813-66-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/997e1bec-8055-4109-b072-41e337a3969a/documents/ae402ed2-c26d-461d-933f-ceaa7cd29529_f5c04a24-29d8-419f-8e00-7ddd3faca0f5.html,,dermal,LD50,"3,160 mg/kg bw",no adverse effect observed, "Hydrocarbons, C10-C13, n-alkanes",129813-66-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/997e1bec-8055-4109-b072-41e337a3969a/documents/ae402ed2-c26d-461d-933f-ceaa7cd29529_f5c04a24-29d8-419f-8e00-7ddd3faca0f5.html,,inhalation,LC50,"6,100 mg/m3",no adverse effect observed, "Alkanes, C10-13-iso-",68551-17-7, Oral NOAEL (Rat): >1000 mg/Kg bw/day Inhalation NOAEC (Rat): ≥ 10400 mg/m3 ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2efd54c0-5533-430a-aaf1-9a53b693df7d/documents/16587c6c-6069-4c88-afa5-6cce6131a92b_de15787d-3c6b-4b0e-95d8-c4bf6a6c3054.html,,,,,, "Alkanes, C10-13-iso-",68551-17-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2efd54c0-5533-430a-aaf1-9a53b693df7d/documents/16587c6c-6069-4c88-afa5-6cce6131a92b_de15787d-3c6b-4b0e-95d8-c4bf6a6c3054.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Alkanes, C10-13-iso-",68551-17-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2efd54c0-5533-430a-aaf1-9a53b693df7d/documents/16587c6c-6069-4c88-afa5-6cce6131a92b_de15787d-3c6b-4b0e-95d8-c4bf6a6c3054.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"10,400 mg/m3",,rat "Alkanes, C10-13-iso-",68551-17-7, Oral LD50 (rat) > 5000 mg/Kg bw Inhalation LC50 (rat) >5000 mg/m³ Dermal LD50 (rabbit) > 3.16 mL/Kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2efd54c0-5533-430a-aaf1-9a53b693df7d/documents/c11fb70a-5ccb-4db1-aec1-0b73e81f0196_de15787d-3c6b-4b0e-95d8-c4bf6a6c3054.html,,,,,, "Alkanes, C10-13-iso-",68551-17-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2efd54c0-5533-430a-aaf1-9a53b693df7d/documents/c11fb70a-5ccb-4db1-aec1-0b73e81f0196_de15787d-3c6b-4b0e-95d8-c4bf6a6c3054.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Alkanes, C10-13-iso-",68551-17-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2efd54c0-5533-430a-aaf1-9a53b693df7d/documents/c11fb70a-5ccb-4db1-aec1-0b73e81f0196_de15787d-3c6b-4b0e-95d8-c4bf6a6c3054.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Alcohols, C11-15-secondary, ethoxylated",68131-40-8," In a 90 -day oral toxicity study in the rat doses of 0, 100, 300 or 1000 mg/kg bw/day were given to male and female rats by oral gavage. No adverse clinical effects, body weight changes, blood or urine clinical pathology changes were observed. Adverse effects were identified by histopathological examination in the forestomach in both males and females and in the kidney of males. The lesions in the forestomach were a consequence of the irritancy of the surfactant test material but is considered to be a rodent-specific finding since there is no forestomach in humans. The hyaline droplet nephropathy findings are also male rat specific and are not relevant to humans. Therefore the human relevant NOAEL can be set at 1000 mg/kg bw/day. No target organ toxicity is identified which is relevant to humans. No repeat dose studies have been conducted by the inhalation or dermal routes. Waivers for inhalation and dermal repeat-dose studies are proposed because: 1. The repeat-dose dermal toxicity of Softanol 30 can be predicted by the oral sub-chronic toxicity study data and the acute dermal toxicity study data. A repeat dose dermal toxicity study is considered unjustified on scientific grounds in view of the mode of action of Softanol 30, a secondary alcohol ethoxylate, whose toxicity is driven by its surfactant properties.  A 90-day oral toxicity study in the rat has been conducted (see below) and the findings are considered sufficient to enable the prediction of repeat-dose dermal toxicity for Softanol 30, using a NOAEL of 1000 mg/kg/day.  It is considered that the toxicity of Softanol 30 by the dermal route is low and there is no requirement to classify as a STOT-RE via the dermal route.   2. The repeat-dose inhalation toxicity of Softanol 30 can be qualitatively predicted based on the general low toxicity of secondary alcohol ethoxylates via oral and dermal routes and the low acute oral and dermal toxicity of Softanol 30 which is considered to have a local mode of toxicity driven by its surfactant properties.   The value of a repeat-dose inhalation toxicity study for Softanol 30 which will only ever be exposed by inhalation to humans as a mixture containing other surfactants is considered to be too low to justify.  Therefore it is considered unjustified on scientific grounds to conduct a repeat-dose inhalation toxicity study nor classify Softanol 30 in relation to STOT-RE respiratory toxicity hazard. 90 -day oral toxicity study Alcohols, C11-15-secondary, ethoxylated was orally administered to male and female rats for 90 days to investigate its potential to induce toxicity and its profile. Following the end of administration, recovery from toxic effects was assessed during a 14-day withdrawal period. In the 1000 mg/kg group, transient inhibition of body weight gain or food consumption was noted at the start of administration in males and females. In the 1000 mg/kg group, necropsy and histopathological examination revealed abnormalities in the forestomach mucosa in both males and females. These changes were likely due to the irritancy of the test substance; however, they were not noted in the necropsy of the preliminary study of Alcohols, C11-15- secondary, ethoxylated (SR15064). Accordingly, these changes were considered influenced by the duration of administration. Histopathological changes in the forestomach mucosa, which were slight in degree, were noted also in males in the 300 mg/kg group. As the severity of the changes in the forestomach mucosa was reduced during the recovery period, they were considered reversible. The liver weight was high and centrilobular hypertrophy of hepatocytes was noted in both males or females in the 1000 mg/kg group. In addition, hypertrophy of follicular cells in the thyroid was noted in males in this group. These changes were considered hepatic enzyme induction, which are adaptive changes accompanying drug-induced metabolic activation of the liver, and their secondary changes. The changes in the liver, of which severity was reduced during the recovery period, were considered to be reversible. The increased liver weight in females in the 300 mg/kg group was considered unrelated to the test article administration because it was within the range of historical control data of the test facility, and no histological changes indicated hepatic enzyme induction. In males in the 1000 mg/kg group, eosinophilic body of proximal tubular epithelium, which was likely to be α2μ-globulin nephropathy that is specific to male rats, was increased in severity compared to that in the other groups. In addition, kidney weight was increased in males of this group. The renal changes were considered to be reversible because their severity was reduced during the recovery period. In females, kidney weight was high in the 100 to 1000 mg/kg groups, which was considered unrelated to the test article administration because it was within the range of historical control data of the test facility and no related histopathological changes were detected. As described above, irritation of the stomach mucosa was noted at 1000 mg/kg in females and 300 mg/kg and higher doses in males; therefore, the no-observed-adverseeffect level (NOAEL) of Alcohols, C11-15-secondary, ethoxylated was considered to be 100 mg/kg in males and 300 mg/kg in females. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/065ae49c-e3cf-4790-8c90-5a1d803dfb68/documents/IUC5-76003195-4c1f-4388-9cdd-e20ef757278c_4a934046-a215-4881-b9d7-0fe732cc7e8e.html,,,,,, "Alcohols, C11-15-secondary, ethoxylated",68131-40-8,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/065ae49c-e3cf-4790-8c90-5a1d803dfb68/documents/IUC5-76003195-4c1f-4388-9cdd-e20ef757278c_4a934046-a215-4881-b9d7-0fe732cc7e8e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Alcohols, C11-15-secondary, ethoxylated",68131-40-8,"The oral LD50 for female rats of Softanol 30 was demonstrated to be greater than 2000 mg/kg bodyweight (HLS 2010, PLZ0014).The dermal LD50 for male and female rats was higher than 2000 mg/kg (RCC 1997, report 650518). A waiver for acute inhalation toxicity has been submitted. The justification for the waiver is that the study is scientifically not necessary / other information available. Acute inhalation exposure to Softanol 30 alone as a mist is unlikely because of the processes used to manufacture the substance and the protective measures in place. Acute inhalation exposure to softanol 30 may occur but will only occur as a mixture with other surfactants which will affect the biological response to the surfactant properties of Softanol 30 which is locally toxic. Therefore the value of an acute inhalation toxicity study is considered to be too low to justify. In general the acute inhalation toxicity of secondary alcohol ethoxylates is low (HERA, 2009). The acute inhalation toxicity of Softanol 30 should not be classified under the CLP regulation. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/065ae49c-e3cf-4790-8c90-5a1d803dfb68/documents/IUC5-927fc1e7-54eb-4879-b820-817536e57f15_4a934046-a215-4881-b9d7-0fe732cc7e8e.html,,,,,, "Alcohols, C11-15-secondary, ethoxylated",68131-40-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/065ae49c-e3cf-4790-8c90-5a1d803dfb68/documents/IUC5-927fc1e7-54eb-4879-b820-817536e57f15_4a934046-a215-4881-b9d7-0fe732cc7e8e.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Alcohols, C11-15-secondary, ethoxylated",68131-40-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/065ae49c-e3cf-4790-8c90-5a1d803dfb68/documents/IUC5-927fc1e7-54eb-4879-b820-817536e57f15_4a934046-a215-4881-b9d7-0fe732cc7e8e.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Alcohols, C12-13",75782-86-4,"In a guideline 28-day study, an oral NOAEL of 300 mg/kg bw/day was determined for Safol 23 (Sasol 1999) but the effects seen in this study are not ascribed to a dose response effect but rather are associated with the method of dosing, and therefore are not suitable as a basis for DNEL. In studies on related materials, oral NOAELS were 2000 mg/kg bw/day for Dodecanol (Hansen 1992a) and 1440 mg/kg bw/day for Alcohols C7-11 branched and linear (Hellwig & Jackh 1997). A read-across from a reliable 13-week dietary study in rats using Hexanol reported a NOAEL of 1127 mg/kg bw/day and no adverse effects were noted at any of the dose levels administered during the study (Scientific Associates Inc. 1966). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e857828a-2c15-4111-833a-d9e8db84ba3f/documents/IUC5-7c1d8390-9491-4995-bbec-fe34a50f55b1_a40e5669-10b9-48ad-83ea-5af4b591d068.html,,,,,, "Alcohols, C12-13",75782-86-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e857828a-2c15-4111-833a-d9e8db84ba3f/documents/IUC5-7c1d8390-9491-4995-bbec-fe34a50f55b1_a40e5669-10b9-48ad-83ea-5af4b591d068.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,723 mg/kg bw/day,,rat "Alcohols, C12-13",75782-86-4,"The key study for acute oral toxicity reports an LD50 value of >2000mg/kg with unremarkable findings at necropsy (Sasol, 1998; rel 1). Similarly, an LD50 of >2000mg/kg is reported for acute dermal toxicity (Sasol, 1998; rel 1). The data for acute inhalation toxicity is waived based on the low toxicity of related alcohols via the inhalation route across category, and the availability of high reliability studies via the oral and dermal routes. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e857828a-2c15-4111-833a-d9e8db84ba3f/documents/IUC5-1e6b3b82-c4db-4f62-96f6-ed357aa9cf89_a40e5669-10b9-48ad-83ea-5af4b591d068.html,,,,,, "Alkanes, C12-14-iso-",68551-19-9, Oral NOAEL (Rat): >1000 mg/Kg bw/day Inhalation NOAEC (Rat): ≥ 10400 mg/m3 ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3357289-2fb0-4e8b-bdd4-9528e1aa41d3/documents/9f55f70e-16b2-4164-ba34-7a4c38dc2b5c_87aa0521-44e7-4d6b-a249-c2dbe1b071ef.html,,,,,, "Alkanes, C12-14-iso-",68551-19-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3357289-2fb0-4e8b-bdd4-9528e1aa41d3/documents/9f55f70e-16b2-4164-ba34-7a4c38dc2b5c_87aa0521-44e7-4d6b-a249-c2dbe1b071ef.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Alkanes, C12-14-iso-",68551-19-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3357289-2fb0-4e8b-bdd4-9528e1aa41d3/documents/9f55f70e-16b2-4164-ba34-7a4c38dc2b5c_87aa0521-44e7-4d6b-a249-c2dbe1b071ef.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"10,400 mg/m3",,rat "Alkanes, C12-14-iso-",68551-19-9, Oral LD50 (rat) > 5000 mg/Kg bw Inhalation LC50 (rat) >5000 mg/m³ Dermal LD50 (rabbit) > 3.16 mL/Kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3357289-2fb0-4e8b-bdd4-9528e1aa41d3/documents/f39ca85d-07ab-4d67-a67b-16e07e423bf5_87aa0521-44e7-4d6b-a249-c2dbe1b071ef.html,,,,,, "Alkanes, C12-14-iso-",68551-19-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3357289-2fb0-4e8b-bdd4-9528e1aa41d3/documents/f39ca85d-07ab-4d67-a67b-16e07e423bf5_87aa0521-44e7-4d6b-a249-c2dbe1b071ef.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Alkanes, C12-14-iso-",68551-19-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3357289-2fb0-4e8b-bdd4-9528e1aa41d3/documents/f39ca85d-07ab-4d67-a67b-16e07e423bf5_87aa0521-44e7-4d6b-a249-c2dbe1b071ef.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Alcohols, C12-14, ethoxylated",68439-50-9," Oral (subacute, rat, m/f, OECD 422): NOAEL (systemic toxicity) ≥ 1000 mg/kg bw/day Oral (subacute, rat, m/f, OECD 422): NOAEL (local toxicity) ≥ 1000 mg/kg bw/day Oral (subchronic, rat, m/f, OECD 408): NOAEL (systemic toxicity) ≥ 1000 mg/kg bw/day Oral (subchronic, rat, m/f, OECD 408): NOAEL (local toxicity) ≥ 1000 mg/kg bw/day   Conclusion based on data obtained with alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) and considering all the available data on repeated dose toxicity in the Alcohol Ethoxylates (AE) category, in a Weight-of-Evidence approach. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8860fe80-b965-4396-8a7c-c8b4cbae94e0/documents/b338025b-823c-460c-be13-cb0d3a55186e_f4c77d00-89ef-4ab5-b0d8-7b9d13ac3609.html,,,,,, "Alcohols, C12-14, ethoxylated",68439-50-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8860fe80-b965-4396-8a7c-c8b4cbae94e0/documents/b338025b-823c-460c-be13-cb0d3a55186e_f4c77d00-89ef-4ab5-b0d8-7b9d13ac3609.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Alcohols, C12-14, ethoxylated",68439-50-9," Oral (rat, m/f, OECD 401): LD50 > 2000 mg/kg bw Conclusion based on data obtained with alcohols, C12-14, ethoxylated (CAS No. 68439-50-9, EC No. 500-213-3) and considering all available data on acute toxicity in the Alcohol Ethoxylates (AE) category in a Weight-of-Evidence approach. Inhalation: No study required as the inhalation route of exposure is considered less relevant than the dermal route for AE substances. Dermal: According to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, no study is required as the AE substances do not meet the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8860fe80-b965-4396-8a7c-c8b4cbae94e0/documents/9391b3d6-7a52-4bb2-8808-c54762793a59_f4c77d00-89ef-4ab5-b0d8-7b9d13ac3609.html,,,,,, "Alcohols, C12-14, ethoxylated",68439-50-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8860fe80-b965-4396-8a7c-c8b4cbae94e0/documents/9391b3d6-7a52-4bb2-8808-c54762793a59_f4c77d00-89ef-4ab5-b0d8-7b9d13ac3609.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Solvent naphtha (petroleum), heavy arom.",64742-94-5,"A number of subacute and subchronic studies with kerosines are available (OECD 410, 412, 413, and other non-guideline protocols). The repeated inhalation and oral studies of kerosine in rats produced no consistent toxicological effects other than changes in male rat kidneys that are not considered relevant to humans. The NOAEC for inhalation exposure is greater than or equal to 1000 mg/m3 (vapour).  The systemic dermal NOAEL is greater than or equal to 495 mg/kg bw/day, based on a well conducted 90-day study in rats.  The NOAEL for systemic effects of oral exposure is 750 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6f0c48e-bd55-48d9-a30c-ccaed3586346/documents/bd929bbb-c8db-4c8c-a90d-cad25fc9c5f5_72a69d65-05e5-4e79-884f-00cbdd672961.html,,,,,, "Solvent naphtha (petroleum), heavy arom.",64742-94-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6f0c48e-bd55-48d9-a30c-ccaed3586346/documents/bd929bbb-c8db-4c8c-a90d-cad25fc9c5f5_72a69d65-05e5-4e79-884f-00cbdd672961.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Solvent naphtha (petroleum), heavy arom.",64742-94-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6f0c48e-bd55-48d9-a30c-ccaed3586346/documents/bd929bbb-c8db-4c8c-a90d-cad25fc9c5f5_72a69d65-05e5-4e79-884f-00cbdd672961.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,495 mg/kg bw/day,,rat "Solvent naphtha (petroleum), heavy arom.",64742-94-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6f0c48e-bd55-48d9-a30c-ccaed3586346/documents/bd929bbb-c8db-4c8c-a90d-cad25fc9c5f5_72a69d65-05e5-4e79-884f-00cbdd672961.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat "Solvent naphtha (petroleum), heavy arom.",64742-94-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6f0c48e-bd55-48d9-a30c-ccaed3586346/documents/bd929bbb-c8db-4c8c-a90d-cad25fc9c5f5_72a69d65-05e5-4e79-884f-00cbdd672961.html,Repeated dose toxicity – local effects,dermal,LOAEL,1 mg/cm2,adverse effect observed,rat "Solvent naphtha (petroleum), heavy arom.",64742-94-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6f0c48e-bd55-48d9-a30c-ccaed3586346/documents/bd929bbb-c8db-4c8c-a90d-cad25fc9c5f5_72a69d65-05e5-4e79-884f-00cbdd672961.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,000 mg/m3",no adverse effect observed,rat "Solvent naphtha (petroleum), heavy arom.",64742-94-5,"Kerosines are of low acute toxicity with mortality rarely reported even at very high exposures in experimental animal studies conducted by oral (similar to OECD 420), dermal (similar to OECD 402), and inhalation (similar to OECD 403) exposure.  • The oral LD50 was > 5000 mg/kg bw in male and female rats for kerosine.• The dermal LD50 was > 2000 mg/kg/bw in male and female rabbits for kerosine.• The inhalation LC50 was > 5.28 mg/L vapour in male and female rats for kerosine. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6f0c48e-bd55-48d9-a30c-ccaed3586346/documents/82237dfe-fd02-46b2-870a-385efbf26c2b_72a69d65-05e5-4e79-884f-00cbdd672961.html,,,,,, "Solvent naphtha (petroleum), heavy arom.",64742-94-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6f0c48e-bd55-48d9-a30c-ccaed3586346/documents/82237dfe-fd02-46b2-870a-385efbf26c2b_72a69d65-05e5-4e79-884f-00cbdd672961.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Solvent naphtha (petroleum), heavy arom.",64742-94-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6f0c48e-bd55-48d9-a30c-ccaed3586346/documents/82237dfe-fd02-46b2-870a-385efbf26c2b_72a69d65-05e5-4e79-884f-00cbdd672961.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Solvent naphtha (petroleum), heavy arom.",64742-94-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6f0c48e-bd55-48d9-a30c-ccaed3586346/documents/82237dfe-fd02-46b2-870a-385efbf26c2b_72a69d65-05e5-4e79-884f-00cbdd672961.html,,inhalation,LC50,"5,280 mg/m3",no adverse effect observed, "Benzoic acid, C12-15-alkyl esters",68411-27-8,"Based on the results of the present Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test, the NOAEL (No Observed Adverse Effect Level) for general, reproductive and developmental toxicity was considered to be 1000 mg/kg/day for males and females.   Oral administration of the structurally related source substance Benzoic Acid Isononylester, to rats, by gavage, for a period of 28 consecutive days resulted in treatment related changes in either sex at a dose level of 1000 mg/kg/day and in males treated with 150 mg/kg/day.   In a subchronic repeated dose toxicity study with the source substance Benzoic Acid Isononylester, there was no evidence of treatment related effects in either sex treated with 300 mg/kg/day, which was the highest administered dose level. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44c0d7dc-87a9-481f-9580-718a5541cc9b/documents/25f07f7d-b481-452d-b578-1f4f527e3351_740bcb46-555b-44c4-aae4-1159d1b33983.html,,,,,, "Benzoic acid, C12-15-alkyl esters",68411-27-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44c0d7dc-87a9-481f-9580-718a5541cc9b/documents/25f07f7d-b481-452d-b578-1f4f527e3351_740bcb46-555b-44c4-aae4-1159d1b33983.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Benzoic acid, C12-15-alkyl esters",68411-27-8,Acute toxicity oral: The acute oral lethal dose (LD50) of the test material in Wistar rats was calculated as being 34500 mg/kg bodyweight. In a second study the acute oral lethal dose (LD50) of the test material in Wistar -derived albino rats was > 5 g/kg bodyweight. Acute toxicity dermal: The acute dermal lethal dose (LD50) of the test material in albino rabbits was found to be greater than 2000 mg/kg bodyweight.Acute toxicity inhalation: In the Acute Inhalation Toxicity study on Wistar-derived rats the LC50 of the test material was determined as being > 200 mg/l. There was a 10 % mortality observed in the exposed rats. Under the conditions if this study the test material is considered to be not toxic by inhalation to rats. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44c0d7dc-87a9-481f-9580-718a5541cc9b/documents/e2aa2aa0-1193-49bf-a0a8-3d3756e6b76c_740bcb46-555b-44c4-aae4-1159d1b33983.html,,,,,, "Benzoic acid, C12-15-alkyl esters",68411-27-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44c0d7dc-87a9-481f-9580-718a5541cc9b/documents/e2aa2aa0-1193-49bf-a0a8-3d3756e6b76c_740bcb46-555b-44c4-aae4-1159d1b33983.html,,oral,LD50,"34,500 mg/kg bw",adverse effect observed, "Benzoic acid, C12-15-alkyl esters",68411-27-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44c0d7dc-87a9-481f-9580-718a5541cc9b/documents/e2aa2aa0-1193-49bf-a0a8-3d3756e6b76c_740bcb46-555b-44c4-aae4-1159d1b33983.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzoic acid, C12-15-alkyl esters",68411-27-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44c0d7dc-87a9-481f-9580-718a5541cc9b/documents/e2aa2aa0-1193-49bf-a0a8-3d3756e6b76c_740bcb46-555b-44c4-aae4-1159d1b33983.html,,inhalation,LC50,200 mg/m3,adverse effect observed, "Hexanoic acid, 2-ethyl-, C12-15-alkyl esters",90411-66-8, Study performed to recognised testing guideline and GLP. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0ed02eb-3f6b-472c-94fb-bde0a5c05c84/documents/4cc2a171-c3ce-40a2-98c7-515ee6b642a6_ae9f972f-c289-4a98-9ca2-d151e0c28385.html,,,,,, "Hexanoic acid, 2-ethyl-, C12-15-alkyl esters",90411-66-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0ed02eb-3f6b-472c-94fb-bde0a5c05c84/documents/4cc2a171-c3ce-40a2-98c7-515ee6b642a6_ae9f972f-c289-4a98-9ca2-d151e0c28385.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Hexanoic acid, 2-ethyl-, C12-15-alkyl esters",90411-66-8, Study conducted to recognised testing guidelines with GLP certification where appropriate. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0ed02eb-3f6b-472c-94fb-bde0a5c05c84/documents/8a8d0124-aa7f-4f98-9fae-d102a8156336_ae9f972f-c289-4a98-9ca2-d151e0c28385.html,,,,,, "Hexanoic acid, 2-ethyl-, C12-15-alkyl esters",90411-66-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0ed02eb-3f6b-472c-94fb-bde0a5c05c84/documents/8a8d0124-aa7f-4f98-9fae-d102a8156336_ae9f972f-c289-4a98-9ca2-d151e0c28385.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hexanoic acid, 2-ethyl-, C12-15-alkyl esters",90411-66-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0ed02eb-3f6b-472c-94fb-bde0a5c05c84/documents/8a8d0124-aa7f-4f98-9fae-d102a8156336_ae9f972f-c289-4a98-9ca2-d151e0c28385.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Propanoic acid, 2-hydroxy-, C12-15-alkyl esters",93925-36-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Low (not assignable). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Based on tests with shorter chain alkyl lactates. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Based on tests with shorter chain alkyl lactates. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): Low (not assignable). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9fa82d8-578e-457f-80f8-32e48aecd1f6/documents/IUC5-903ca0b3-548e-4889-b8ec-7462a85b70a5_524c24b5-6ee1-41dc-b0e3-c8b38f4d1e15.html,,,,,, "Propanoic acid, 2-hydroxy-, C12-15-alkyl esters",93925-36-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9fa82d8-578e-457f-80f8-32e48aecd1f6/documents/IUC5-903ca0b3-548e-4889-b8ec-7462a85b70a5_524c24b5-6ee1-41dc-b0e3-c8b38f4d1e15.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rat "Propanoic acid, 2-hydroxy-, C12-15-alkyl esters",93925-36-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9fa82d8-578e-457f-80f8-32e48aecd1f6/documents/IUC5-903ca0b3-548e-4889-b8ec-7462a85b70a5_524c24b5-6ee1-41dc-b0e3-c8b38f4d1e15.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,600 mg/m3,,rat "Propanoic acid, 2-hydroxy-, C12-15-alkyl esters",93925-36-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9fa82d8-578e-457f-80f8-32e48aecd1f6/documents/IUC5-903ca0b3-548e-4889-b8ec-7462a85b70a5_524c24b5-6ee1-41dc-b0e3-c8b38f4d1e15.html,Repeated dose toxicity – local effects,inhalation,NOAEC,200 mg/m3,adverse effect observed,rat "Propanoic acid, 2-hydroxy-, C12-15-alkyl esters",93925-36-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): High Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): High; no mortality occurred at levels of > 2000 to > 5000 mg/m3. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): High; dermal exposure to a combination of dodecyl and tridecyl lactates induced no mortality at levels of > 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9fa82d8-578e-457f-80f8-32e48aecd1f6/documents/IUC5-b71bd512-737e-4d52-a0c8-8369b8c2864d_524c24b5-6ee1-41dc-b0e3-c8b38f4d1e15.html,,,,,, "Propanoic acid, 2-hydroxy-, C12-15-alkyl esters",93925-36-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9fa82d8-578e-457f-80f8-32e48aecd1f6/documents/IUC5-b71bd512-737e-4d52-a0c8-8369b8c2864d_524c24b5-6ee1-41dc-b0e3-c8b38f4d1e15.html,,oral,LD50,"20,000 mg/kg bw",no adverse effect observed, "Propanoic acid, 2-hydroxy-, C12-15-alkyl esters",93925-36-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9fa82d8-578e-457f-80f8-32e48aecd1f6/documents/IUC5-b71bd512-737e-4d52-a0c8-8369b8c2864d_524c24b5-6ee1-41dc-b0e3-c8b38f4d1e15.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Propanoic acid, 2-hydroxy-, C12-15-alkyl esters",93925-36-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9fa82d8-578e-457f-80f8-32e48aecd1f6/documents/IUC5-b71bd512-737e-4d52-a0c8-8369b8c2864d_524c24b5-6ee1-41dc-b0e3-c8b38f4d1e15.html,,inhalation,discriminating conc.,"2,000 mg/m3",adverse effect observed, "Alcohols, C12-15, ethoxylated",68131-39-5," Oral (subacute, rat, m/f, OECD 422): NOAEL (systemic toxicity) = 1000 mg/kg bw/day Oral (subacute, rat, m/f, OECD 422): NOAEL (local toxicity) = 1000 mg/kg bw/day   Oral (subchronic, rat, m/f, OECD 408): NOAEL (systemic toxicity) = 1000 mg/kg bw/day Oral (subchronic, rat, m/f, OECD 408): NOAEL (local toxicity) = 300 mg/kg bw/day   Conclusion based on data obtained with alcohols, C12-15, branched and linear, ethoxylated (CAS No. 106232-83-1, EC No. 500-294-5) and considering all the available data on repeated dose toxicity in the Alcohol Ethoxylates (AE) category, in a Weight-of-Evidence approach. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd489b81-4e46-4b8a-bcc4-962da7006bff/documents/IUC5-5a4ef6cb-d4a3-48b3-9d58-e0cad0334e6e_3e42ce68-4828-4730-b3a1-ea13eafad8a8.html,,,,,, "Alcohols, C12-15, ethoxylated",68131-39-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd489b81-4e46-4b8a-bcc4-962da7006bff/documents/IUC5-5a4ef6cb-d4a3-48b3-9d58-e0cad0334e6e_3e42ce68-4828-4730-b3a1-ea13eafad8a8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Alcohols, C12-15, ethoxylated",68131-39-5," Oral: LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute oral toxicity in the Alcohol Ethoxylates (AE) category in a Weight-of-Evidence approach. Inhalation: No study required as the inhalation route of exposure is considered less relevant than the dermal route for AE substances. Dermal: According to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, no study is required as the AE substances do not meet the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd489b81-4e46-4b8a-bcc4-962da7006bff/documents/1ada3b36-ba1f-4cf4-a9f5-9b3c222cbd14_3e42ce68-4828-4730-b3a1-ea13eafad8a8.html,,,,,, "Alcohols, C12-15, ethoxylated",68131-39-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd489b81-4e46-4b8a-bcc4-962da7006bff/documents/1ada3b36-ba1f-4cf4-a9f5-9b3c222cbd14_3e42ce68-4828-4730-b3a1-ea13eafad8a8.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Glycerides, C12-18",67701-26-2,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca6b7634-be69-4b4c-88c8-dae23fde8274/documents/IUC5-a7441c24-a9d1-4277-8d42-603d79a6ca69_ff2e5d4f-5c02-4f3d-a034-e6577a4fa0ef.html,,,,,, "Glycerides, C12-18",67701-26-2,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca6b7634-be69-4b4c-88c8-dae23fde8274/documents/IUC5-10d75d70-87b2-49ae-9752-ad7c9a8456c3_ff2e5d4f-5c02-4f3d-a034-e6577a4fa0ef.html,,,,,, "Distillates (petroleum), hydrotreated light",64742-47-8,"A number of subacute and subchronic studies with kerosines and jet fuels are available (OECD 410, 412, 413, and other non-guideline protocols). The repeated inhalation and oral studies of kerosine in rats produced no consistent toxicological effects other than changes in male rat kidneys that are not considered relevant to humans. The NOAEC for inhalation exposure is greater than or equal to 1000 mg/m3 (vapour).  The systemic dermal NOAEL is greater than or equal to 495 mg/kg bw/day, based on a well conducted 90-day study in rats.  The NOAEL for systemic effects of oral exposure is 750 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff20186a-b22c-453c-9b77-f7a9cb8035fa/documents/89277e09-fd6a-4778-85aa-41521a1ff043_c76d4855-a225-4606-a967-fe2932854d21.html,,,,,, "Distillates (petroleum), hydrotreated light",64742-47-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff20186a-b22c-453c-9b77-f7a9cb8035fa/documents/89277e09-fd6a-4778-85aa-41521a1ff043_c76d4855-a225-4606-a967-fe2932854d21.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Distillates (petroleum), hydrotreated light",64742-47-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff20186a-b22c-453c-9b77-f7a9cb8035fa/documents/89277e09-fd6a-4778-85aa-41521a1ff043_c76d4855-a225-4606-a967-fe2932854d21.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,495 mg/kg bw/day,,rat "Distillates (petroleum), hydrotreated light",64742-47-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff20186a-b22c-453c-9b77-f7a9cb8035fa/documents/89277e09-fd6a-4778-85aa-41521a1ff043_c76d4855-a225-4606-a967-fe2932854d21.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat "Distillates (petroleum), hydrotreated light",64742-47-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff20186a-b22c-453c-9b77-f7a9cb8035fa/documents/89277e09-fd6a-4778-85aa-41521a1ff043_c76d4855-a225-4606-a967-fe2932854d21.html,Repeated dose toxicity – local effects,dermal,LOAEL,1 mg/cm2,adverse effect observed,rat "Distillates (petroleum), hydrotreated light",64742-47-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff20186a-b22c-453c-9b77-f7a9cb8035fa/documents/89277e09-fd6a-4778-85aa-41521a1ff043_c76d4855-a225-4606-a967-fe2932854d21.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,000 mg/m3",no adverse effect observed,rat "Distillates (petroleum), hydrotreated light",64742-47-8,"Kerosines are of low acute toxicity with mortality rarely reported even at very high exposures in experimental animal studies conducted by oral (similar to OECD 420), dermal (similar to OECD 402), and inhalation (similar to OECD 403) exposure.  • The oral LD50 was > 5000 mg/kg bw in male and female rats for kerosine.• The dermal LD50 was > 2000 mg/kg/bw in male and female rabbits for kerosine.• The inhalation LC50 was > 5.28 mg/L vapour in male and female rats for kerosine. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff20186a-b22c-453c-9b77-f7a9cb8035fa/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_c76d4855-a225-4606-a967-fe2932854d21.html,,,,,, "Distillates (petroleum), hydrotreated light",64742-47-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff20186a-b22c-453c-9b77-f7a9cb8035fa/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_c76d4855-a225-4606-a967-fe2932854d21.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated light",64742-47-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff20186a-b22c-453c-9b77-f7a9cb8035fa/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_c76d4855-a225-4606-a967-fe2932854d21.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated light",64742-47-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff20186a-b22c-453c-9b77-f7a9cb8035fa/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_c76d4855-a225-4606-a967-fe2932854d21.html,,inhalation,LC50,"5,280 mg/m3",no adverse effect observed, "Distillates (petroleum), hydrotreated middle",64742-46-7," There are three sub-acute repeated dose oral studies conducted according to OECD TG 422 and one 90 -day oral toxicity study according to OECD TG 408. In a 90-day oral study on CAS 64742-79-6, there were no treatment related adverse effects on systemic toxicity up to and including the highest dose of 1000 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 1000 mg/kg/day corresponding achieved dose level of 970 mg/kg/day for males and 971 mg/kg/day for females (under the test conditions and doses employed). In sub-acute oral studies on CAS 64742-79-6 and CAS 64742-46-7, there were no treatment-related adverse effects on systemic toxicity parameters up to and including the highest doses tested (1000 and 750 mg/kg/day respectively) and accordingly the NOAELs were set at these levels. In a sub-acute oral study on CAS 64742-80-9 (conducted according to OECD TG 422) at doses of 100, 300 and 1000 mg/kg/day. At 300 mg/kg/day, there were minimal gross pathological, histopathological, or biochemical treatment-related effects such as higher liver weights, spleen weights, hypertrophy in liver, follicular epithelial hypertrophy in thyroid and hyaline droplets in kidneys. This dose was determined to be the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats. A second OECD 422 study on CAS 64742-80-9 has recently reported and is included as an endpoint study record; results and potential follow-up actions (further testing proposals and/or classification) are currently under discussion and are not yet included in this summary section. In two 28-day inhalation studies with hydrodesulphurised middle distillates(CAS 64742-80-9), the Lowest Observed Adverse Effect Level (LOAEL) values were 23 and 24 mg/m3(equivalent to OECD TG 412).  These studies and values were considered unreliable.     A 90-day inhalation study of diesel fuel (aerosol) (a read-across study from VHGO category; substance CAS 68334-30-5) resulted in a conservative sub-chronic No Observed Adverse Effect Concentration (NOAEC) of 0.88 mg/L determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of greater than or equal to 1.71 mg/L was established for systemic effects, based on no significant findings at this level (OECD TG 413).   The systemic NOAEL for 28-day dermal exposure to other gas oils was 1000 mg/kg/day, based on moribund state and early mortality in the higher dose groups (OECD TG 410).   In a read-across study (from the CrackedGO category; substance CAS 64741-59-9), a systemic NOAEL of 25 mg/kg body weight/day was obtained for males, and 125 mg/kg body weight/day for females, based upon reductions in thymus weight (OECD TG 411).  In another 90-day sub-chronic study (OECD TG 411),  dermal exposure to coker light gas oil resulted in a systemic LOAEL of 30 mg/kg body weight/day for males and females, based upon clinical signs and irritation noted at all doses. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0e5b970-8ae7-4f4e-9004-951c70426c92/documents/4153b25a-c693-4dd2-840b-48bff6f387a4_490b0087-9bf7-4cf4-904e-f05090360234.html,,,,,, "Distillates (petroleum), hydrotreated middle",64742-46-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0e5b970-8ae7-4f4e-9004-951c70426c92/documents/4153b25a-c693-4dd2-840b-48bff6f387a4_490b0087-9bf7-4cf4-904e-f05090360234.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Distillates (petroleum), hydrotreated middle",64742-46-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0e5b970-8ae7-4f4e-9004-951c70426c92/documents/4153b25a-c693-4dd2-840b-48bff6f387a4_490b0087-9bf7-4cf4-904e-f05090360234.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), hydrotreated middle",64742-46-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0e5b970-8ae7-4f4e-9004-951c70426c92/documents/4153b25a-c693-4dd2-840b-48bff6f387a4_490b0087-9bf7-4cf4-904e-f05090360234.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Distillates (petroleum), hydrotreated middle",64742-46-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0e5b970-8ae7-4f4e-9004-951c70426c92/documents/4153b25a-c693-4dd2-840b-48bff6f387a4_490b0087-9bf7-4cf4-904e-f05090360234.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Distillates (petroleum), hydrotreated middle",64742-46-7,"Acute Oral Toxicity:The acute oral LD50 for other gas oils is > 5000 mg/kg of bodyweight in male and female rats, based on no mortality and minimal signs of toxicity (OECD 401).Acute Inhalation Toxicity:The acute inhalation LC50 for other gas oils for both male and female rats is 4.6 mg/L (aerosol) (OECD 403). This is supported by a further study  in which a hydrodesulphurised middle distillate gave an LC50 of 7.64 mg/L (aerosol). In addition a read-across study with a straight run gas oil gave an LC50 of >2.53 mg/lAcute Dermal Toxicity:The acute dermal LD50 for other gas oils is > 2000mg/kg body weight for male and female rabbits, based on no mortality or evidence of adverse effects (OECD 402). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0e5b970-8ae7-4f4e-9004-951c70426c92/documents/c88d6084-86a3-40df-b097-077ae945a66f_490b0087-9bf7-4cf4-904e-f05090360234.html,,,,,, "Distillates (petroleum), hydrotreated middle",64742-46-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0e5b970-8ae7-4f4e-9004-951c70426c92/documents/c88d6084-86a3-40df-b097-077ae945a66f_490b0087-9bf7-4cf4-904e-f05090360234.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated middle",64742-46-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0e5b970-8ae7-4f4e-9004-951c70426c92/documents/c88d6084-86a3-40df-b097-077ae945a66f_490b0087-9bf7-4cf4-904e-f05090360234.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated middle",64742-46-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0e5b970-8ae7-4f4e-9004-951c70426c92/documents/c88d6084-86a3-40df-b097-077ae945a66f_490b0087-9bf7-4cf4-904e-f05090360234.html,,inhalation,LC50,"4,600 mg/m3",no adverse effect observed, "Alcohols, C14-15",75782-87-5,"In a reliable 90-day study, using a protocol similar to OECD guideline 408, an oral NOAEL of 169 mg/kg bw/day was determined for the test substance in rats (Ito et al. 1978) but the effects seen in this study are not ascribed to a dose response effect, and therefore are not suitable as a basis for DNEL. Studies with Hexadecanol and Alcohols C16-18 and C18 unsatd. gave NOAELs of >4257 (Scientific Associates 1996a). A read-across from a reliable 13-week dietary study in rats using Hexanol reported a NOAEL of 1127 mg/kg bw/day and no adverse effects were noted at any of the dose levels administered during the study (Scientific Associates Inc. 1966). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30381b2e-f6d2-4be5-bb19-5e46ba8aeca1/documents/IUC5-3586eb5a-02e0-4636-8aa8-2d946052b576_e83ac6d2-99ca-45d8-9ca1-064d9edb467a.html,,,,,, "Alcohols, C14-15",75782-87-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30381b2e-f6d2-4be5-bb19-5e46ba8aeca1/documents/IUC5-3586eb5a-02e0-4636-8aa8-2d946052b576_e83ac6d2-99ca-45d8-9ca1-064d9edb467a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,723 mg/kg bw/day,,rat "Alcohols, C14-15",75782-87-5,"The key study for acute oral toxicity reports an LD50 value of >5000 mg/kg in rat (Biolab 1990; rel 2). The acute dermal study reports an LD50 value of 6180mg/kg (Lifestream Laboratories, 1966; rel 2) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30381b2e-f6d2-4be5-bb19-5e46ba8aeca1/documents/IUC5-e3040a40-25bc-4a37-994f-92e4dd328ad5_e83ac6d2-99ca-45d8-9ca1-064d9edb467a.html,,,,,, "Distillates (petroleum), heavy hydrocracked",64741-76-0,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98792d55-4231-4a41-a3f2-c1b9fd43c544/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_c72bb633-8ab7-4a08-b525-bee2e4826b5b.html,,,,,, "Distillates (petroleum), heavy hydrocracked",64741-76-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98792d55-4231-4a41-a3f2-c1b9fd43c544/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_c72bb633-8ab7-4a08-b525-bee2e4826b5b.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Distillates (petroleum), heavy hydrocracked",64741-76-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98792d55-4231-4a41-a3f2-c1b9fd43c544/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_c72bb633-8ab7-4a08-b525-bee2e4826b5b.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Distillates (petroleum), heavy hydrocracked",64741-76-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98792d55-4231-4a41-a3f2-c1b9fd43c544/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_c72bb633-8ab7-4a08-b525-bee2e4826b5b.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Distillates (petroleum), heavy hydrocracked",64741-76-0,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 =  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 =  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 = 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98792d55-4231-4a41-a3f2-c1b9fd43c544/documents/73761dae-46d6-428e-8e40-e5cc70088d96_c72bb633-8ab7-4a08-b525-bee2e4826b5b.html,,,,,, "Distillates (petroleum), heavy hydrocracked",64741-76-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98792d55-4231-4a41-a3f2-c1b9fd43c544/documents/73761dae-46d6-428e-8e40-e5cc70088d96_c72bb633-8ab7-4a08-b525-bee2e4826b5b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), heavy hydrocracked",64741-76-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98792d55-4231-4a41-a3f2-c1b9fd43c544/documents/73761dae-46d6-428e-8e40-e5cc70088d96_c72bb633-8ab7-4a08-b525-bee2e4826b5b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), heavy hydrocracked",64741-76-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98792d55-4231-4a41-a3f2-c1b9fd43c544/documents/73761dae-46d6-428e-8e40-e5cc70088d96_c72bb633-8ab7-4a08-b525-bee2e4826b5b.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Distillates (petroleum), hydrotreated light paraffinic",64742-55-8,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f85c547-18df-4fb1-ab97-0b6611619ecd/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_9962d77e-7e69-4ac7-a4b0-ff54337745dd.html,,,,,, "Distillates (petroleum), hydrotreated light paraffinic",64742-55-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f85c547-18df-4fb1-ab97-0b6611619ecd/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_9962d77e-7e69-4ac7-a4b0-ff54337745dd.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Distillates (petroleum), hydrotreated light paraffinic",64742-55-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f85c547-18df-4fb1-ab97-0b6611619ecd/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_9962d77e-7e69-4ac7-a4b0-ff54337745dd.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Distillates (petroleum), hydrotreated light paraffinic",64742-55-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f85c547-18df-4fb1-ab97-0b6611619ecd/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_9962d77e-7e69-4ac7-a4b0-ff54337745dd.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Distillates (petroleum), hydrotreated light paraffinic",64742-55-8,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f85c547-18df-4fb1-ab97-0b6611619ecd/documents/73761dae-46d6-428e-8e40-e5cc70088d96_9962d77e-7e69-4ac7-a4b0-ff54337745dd.html,,,,,, "Distillates (petroleum), hydrotreated light paraffinic",64742-55-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f85c547-18df-4fb1-ab97-0b6611619ecd/documents/73761dae-46d6-428e-8e40-e5cc70088d96_9962d77e-7e69-4ac7-a4b0-ff54337745dd.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated light paraffinic",64742-55-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f85c547-18df-4fb1-ab97-0b6611619ecd/documents/73761dae-46d6-428e-8e40-e5cc70088d96_9962d77e-7e69-4ac7-a4b0-ff54337745dd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated light paraffinic",64742-55-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f85c547-18df-4fb1-ab97-0b6611619ecd/documents/73761dae-46d6-428e-8e40-e5cc70088d96_9962d77e-7e69-4ac7-a4b0-ff54337745dd.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Fatty acids, C18-36, esters with ethylene glycol",94944-95-3," The analogue substance (Glycerides, Montan wax) was administered to Wistar rats in the feed on 90 consecutive days in four groups (15 males and females each) with 0; 2000; 10000 and 50000 mg/kg diet. The behaviour, state of health, body weight development and the relative feed and water consumption of the animals were not affected in the exposed groups. In the middle and at the end of the exposure significant differences in some of the haematological parameters appeared between the higher dosage samples and the controls. Since, however, all values lay within the normal range for the rat strain used and the animals' ages, there was no indication of a substance-related effects. With respect to the clinical-chemical parameters the substance dose of 50,000 mg/kg feed caused a significant reduction in urea nitrogen in males, and an increase in the uric acid of males and in potassium of females. Since the values lay within the normal range, the changes have been evaluated as being biologically irrelevant. There were no abnormal urinalysis findings. Macroscopic evaluation showed that there were no substance-related, statistically significant changes in the relative organ weights. There were no gross findings and histopathology did not show any adverse effects. Therefore the NOAEL of this study was 50000 mg/kg diet, corresponding to body doses of 3916 mg/kg bw/day for males and 4090 mg/kg bw/day for females (Corley 1980). A chronic toxicity study was conducted in male Wistar rats administered ethylene glycol via the diet at 0, 50, 150, 300, or 400 mg/kg/day for up to twelve months. Mortality occurred in 5 of 20 rats at 300 mg/kg/day (days 111–221) and 4 of 20 rats at 400 mg/kg/day (days 43–193), with remaining rats at this dose euthanized early (day 203) due to excessive weight loss. Increased water consumption and urine volume with decreased specific gravity occurred at 300 mg/kg/day presumably due to osmotic diuresis. Calculi (calcium oxalate crystals) occurred in the bladder or renal pelvis at ≥300 mg/kg bw. Rats dying early at ≥300 mg/kg/day had transitional cell hyperplasia with inflammation and hemorrhage of the bladder wall. Crystal nephropathy (basophilic foci, tubule or pelvic dilatation, birefringent crystals in the pelvic fornix, or transitional cell hyperplasia) affected most rats at 300 mg/kg/day, all at 400 mg/kg/day, but none at ≤150 mg/kg/day. The NOAEL of 150 mg/kg/day is the same as that reported after 16-week exposure and appears to be a threshold dose below which no renal toxicity occurs, regardless of exposure duration. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0873b856-5053-44a9-8cb1-9c9e8ad916c6/documents/7488711e-e7c6-475c-aff8-1bccf2d77a9d_4f33728c-f98d-4019-8bd4-0bc48378ee2c.html,,,,,, "Fatty acids, C18-36, esters with ethylene glycol",94944-95-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0873b856-5053-44a9-8cb1-9c9e8ad916c6/documents/7488711e-e7c6-475c-aff8-1bccf2d77a9d_4f33728c-f98d-4019-8bd4-0bc48378ee2c.html,Chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Fatty acids, C18-36, esters with ethylene glycol",94944-95-3, The LD50 of the substance is > 6400 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0873b856-5053-44a9-8cb1-9c9e8ad916c6/documents/899a3d1b-0c74-48e2-8faa-4783971e4535_4f33728c-f98d-4019-8bd4-0bc48378ee2c.html,,,,,, "Fatty acids, C18-36, esters with ethylene glycol",94944-95-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0873b856-5053-44a9-8cb1-9c9e8ad916c6/documents/899a3d1b-0c74-48e2-8faa-4783971e4535_4f33728c-f98d-4019-8bd4-0bc48378ee2c.html,,oral,LD50,"6,400 mg/kg bw",no adverse effect observed, "Glycerides, C18-36",91052-08-3," Oral: OECD 422, rat, NOAEL ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec685cff-4bab-4a1d-a87c-b3f01eb1eda5/documents/2d3f15f3-2768-4dbc-b4bb-3ce66359cb72_96df0fe5-7107-4e43-a94e-7e2c131cd9e0.html,,,,,, "Glycerides, C18-36",91052-08-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec685cff-4bab-4a1d-a87c-b3f01eb1eda5/documents/2d3f15f3-2768-4dbc-b4bb-3ce66359cb72_96df0fe5-7107-4e43-a94e-7e2c131cd9e0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Glycerides, C18-36",91052-08-3, Oral (OECD 401): LD50 > 2000 mg/kg bw Dermal (OECD 402): LD50 > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec685cff-4bab-4a1d-a87c-b3f01eb1eda5/documents/f682428b-84f1-46c5-bf7e-193b2759ea07_96df0fe5-7107-4e43-a94e-7e2c131cd9e0.html,,,,,, "Glycerides, C18-36",91052-08-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec685cff-4bab-4a1d-a87c-b3f01eb1eda5/documents/f682428b-84f1-46c5-bf7e-193b2759ea07_96df0fe5-7107-4e43-a94e-7e2c131cd9e0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Glycerides, C18-36",91052-08-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec685cff-4bab-4a1d-a87c-b3f01eb1eda5/documents/f682428b-84f1-46c5-bf7e-193b2759ea07_96df0fe5-7107-4e43-a94e-7e2c131cd9e0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Alkenes, C20-24 α-",93924-10-8," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a421dbdc-9d40-442d-833b-5886c4d754cb/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_9cbf079c-23a2-49e7-a593-730864b956ff.html,,,,,, "Alkenes, C20-24 α-",93924-10-8,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a421dbdc-9d40-442d-833b-5886c4d754cb/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_9cbf079c-23a2-49e7-a593-730864b956ff.html,,,,,, "Alkenes, C24-28 α-",93924-11-9," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92b468c3-05b2-4257-94df-2b83da1bbc3a/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_e7e98ae4-ffee-4032-95ac-d4d3cfec2490.html,,,,,, "Alkenes, C24-28 α-",93924-11-9,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92b468c3-05b2-4257-94df-2b83da1bbc3a/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_e7e98ae4-ffee-4032-95ac-d4d3cfec2490.html,,,,,, "Naphtha (petroleum), hydrodesulfurized heavy",64742-82-1,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/601b6970-ec8f-4618-a4f2-dbf3e418df9a/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_b268de16-68f8-4790-acf4-29ba3765bf28.html,,,,,, "Naphtha (petroleum), hydrodesulfurized heavy",64742-82-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/601b6970-ec8f-4618-a4f2-dbf3e418df9a/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_b268de16-68f8-4790-acf4-29ba3765bf28.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), hydrodesulfurized heavy",64742-82-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/601b6970-ec8f-4618-a4f2-dbf3e418df9a/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_b268de16-68f8-4790-acf4-29ba3765bf28.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), hydrodesulfurized heavy",64742-82-1," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/601b6970-ec8f-4618-a4f2-dbf3e418df9a/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_b268de16-68f8-4790-acf4-29ba3765bf28.html,,,,,, "Naphtha (petroleum), hydrodesulfurized heavy",64742-82-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/601b6970-ec8f-4618-a4f2-dbf3e418df9a/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_b268de16-68f8-4790-acf4-29ba3765bf28.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), hydrodesulfurized heavy",64742-82-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/601b6970-ec8f-4618-a4f2-dbf3e418df9a/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_b268de16-68f8-4790-acf4-29ba3765bf28.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), hydrodesulfurized heavy",64742-82-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/601b6970-ec8f-4618-a4f2-dbf3e418df9a/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_b268de16-68f8-4790-acf4-29ba3765bf28.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha (petroleum), hydrotreated light",64742-49-0,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89b10cff-ab85-4101-9d24-9202cd553328/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_6a3d8c39-1512-4a9a-bf58-9140544a7c4b.html,,,,,, "Naphtha (petroleum), hydrotreated light",64742-49-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89b10cff-ab85-4101-9d24-9202cd553328/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_6a3d8c39-1512-4a9a-bf58-9140544a7c4b.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), hydrotreated light",64742-49-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89b10cff-ab85-4101-9d24-9202cd553328/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_6a3d8c39-1512-4a9a-bf58-9140544a7c4b.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), hydrotreated light",64742-49-0," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89b10cff-ab85-4101-9d24-9202cd553328/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_6a3d8c39-1512-4a9a-bf58-9140544a7c4b.html,,,,,, "Naphtha (petroleum), hydrotreated light",64742-49-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89b10cff-ab85-4101-9d24-9202cd553328/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_6a3d8c39-1512-4a9a-bf58-9140544a7c4b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), hydrotreated light",64742-49-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89b10cff-ab85-4101-9d24-9202cd553328/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_6a3d8c39-1512-4a9a-bf58-9140544a7c4b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), hydrotreated light",64742-49-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89b10cff-ab85-4101-9d24-9202cd553328/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_6a3d8c39-1512-4a9a-bf58-9140544a7c4b.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Solvent naphtha (petroleum), light arom.",64742-95-6,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9b4b0c6-0d19-4b17-b6bc-50636197e69c/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_3e4b5751-b68d-47a2-8dd0-35ddd818f146.html,,,,,, "Solvent naphtha (petroleum), light arom.",64742-95-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9b4b0c6-0d19-4b17-b6bc-50636197e69c/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_3e4b5751-b68d-47a2-8dd0-35ddd818f146.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Solvent naphtha (petroleum), light arom.",64742-95-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9b4b0c6-0d19-4b17-b6bc-50636197e69c/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_3e4b5751-b68d-47a2-8dd0-35ddd818f146.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Solvent naphtha (petroleum), light arom.",64742-95-6," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9b4b0c6-0d19-4b17-b6bc-50636197e69c/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_3e4b5751-b68d-47a2-8dd0-35ddd818f146.html,,,,,, "Solvent naphtha (petroleum), light arom.",64742-95-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9b4b0c6-0d19-4b17-b6bc-50636197e69c/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_3e4b5751-b68d-47a2-8dd0-35ddd818f146.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Solvent naphtha (petroleum), light arom.",64742-95-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9b4b0c6-0d19-4b17-b6bc-50636197e69c/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_3e4b5751-b68d-47a2-8dd0-35ddd818f146.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Solvent naphtha (petroleum), light arom.",64742-95-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9b4b0c6-0d19-4b17-b6bc-50636197e69c/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_3e4b5751-b68d-47a2-8dd0-35ddd818f146.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Alcohols, C9-11, ethoxylated",68439-46-3,For the whole category of alcohol ethoxylates (AE) a NOAEL of 500 mg/kg bw/day was established. ,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9478d9d7-2a6a-4941-9833-5491aa397160/documents/IUC5-3168ddf2-3f74-4e85-9b22-e28db6f387d6_c9be533c-dded-4776-b2b3-68c642e7800b.html,,,,,, "Alcohols, C9-11, ethoxylated",68439-46-3,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9478d9d7-2a6a-4941-9833-5491aa397160/documents/IUC5-3168ddf2-3f74-4e85-9b22-e28db6f387d6_c9be533c-dded-4776-b2b3-68c642e7800b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Alcohols, C9-11, ethoxylated",68439-46-3,"Oral (OECD 401), rat: LD50 = 3488 mg/kg bwDermal (OECD 402), rat and rabbit: LD50 > 2000 mg/kg bwInhalation (OECD 403), rat, 4 h, (limit test): LC50 > 1600mg/m³ (maximum technically attainable concentration) ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9478d9d7-2a6a-4941-9833-5491aa397160/documents/IUC5-b88b55fa-5d4b-4418-9234-8876c0d30aa9_c9be533c-dded-4776-b2b3-68c642e7800b.html,,,,,, "Alcohols, C9-11, ethoxylated",68439-46-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9478d9d7-2a6a-4941-9833-5491aa397160/documents/IUC5-b88b55fa-5d4b-4418-9234-8876c0d30aa9_c9be533c-dded-4776-b2b3-68c642e7800b.html,,oral,LD50,"3,488 mg/kg bw",no adverse effect observed, "Alcohols, C9-11, ethoxylated",68439-46-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9478d9d7-2a6a-4941-9833-5491aa397160/documents/IUC5-b88b55fa-5d4b-4418-9234-8876c0d30aa9_c9be533c-dded-4776-b2b3-68c642e7800b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Alcohols, C9-11, ethoxylated",68439-46-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9478d9d7-2a6a-4941-9833-5491aa397160/documents/IUC5-b88b55fa-5d4b-4418-9234-8876c0d30aa9_c9be533c-dded-4776-b2b3-68c642e7800b.html,,inhalation,LC50,"1,600 mg/m3",no adverse effect observed, Caffeine,58-08-2,"ORAL In a 90-day subchronic toxicity study (NTP 1983) Caffeine (purity 99.9%) was administered to 12 Fischer 344 rats/sex/dose in water at dose levels of 0, 188, 375, 750, 1500, 3000 ppm (0, 19.7, 41.8, 85.4, 151.0, 271.9 mg/kg bw/d for males); 0, 23.1, 51.0, 104.2, 174.2, 287.0 mg/kg bw/d for females). The LOAEL is 3000 ppm. The NOAEL is 1500 ppm. In a 90-day subchronic toxicity study (NTP 1983) Caffeine (purity 99.9%) was administered to 12 B6C3F1 mice/sex/dose in water at dose levels of 0, 94, 188, 375, 750, 1500 ppm (0, 21.4, 43.6, 85.4, 130.5, 167.4 mg/kg/d for males; 0, 24.6, 46.6, 87.9, 134.4, 179.4 mg/kg/d for females). The NOAEL is 1500 ppm (the highest dose administered). DERMAL and INHALATION No valid studies are available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79b4a36c-d06d-4578-9fba-cb0879fdd6f9/documents/IUC5-389e5d97-0387-40d7-9a55-47c684d1d61c_c011611b-b4bd-47de-957a-ae3f69c7d570.html,,,,,, Caffeine,58-08-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79b4a36c-d06d-4578-9fba-cb0879fdd6f9/documents/IUC5-389e5d97-0387-40d7-9a55-47c684d1d61c_c011611b-b4bd-47de-957a-ae3f69c7d570.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,151 mg/kg bw/day,, Caffeine,58-08-2,"ORALLD50 Combined = 367.7 mg/kg bw Caffeine is of SLIGHT Toxicity based on the LD50 in males and females.DERMAL LD50 Combined > 2000 mg/kg bw (no mortality occurred, limit test) Caffeine of LOW Toxicity based on an LD50 exceeding 2000 mg/kg bw. INHALATION LC50 Combined: ca. 4.94 mg/L Caffeine is of SLIGHT to LOW toxicity based on the LD50 in males and females. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79b4a36c-d06d-4578-9fba-cb0879fdd6f9/documents/IUC5-d2f854b7-252e-4dc1-a024-b3dbd90bc927_c011611b-b4bd-47de-957a-ae3f69c7d570.html,,,,,, Caffeine,58-08-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79b4a36c-d06d-4578-9fba-cb0879fdd6f9/documents/IUC5-d2f854b7-252e-4dc1-a024-b3dbd90bc927_c011611b-b4bd-47de-957a-ae3f69c7d570.html,,oral,LD50,367.7 mg/kg bw,, Caffeine,58-08-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79b4a36c-d06d-4578-9fba-cb0879fdd6f9/documents/IUC5-d2f854b7-252e-4dc1-a024-b3dbd90bc927_c011611b-b4bd-47de-957a-ae3f69c7d570.html,,dermal,LD50,"2,000 mg/kg bw",, Caffeine,58-08-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79b4a36c-d06d-4578-9fba-cb0879fdd6f9/documents/IUC5-d2f854b7-252e-4dc1-a024-b3dbd90bc927_c011611b-b4bd-47de-957a-ae3f69c7d570.html,,inhalation,LC50,"4,940 mg/m3",, Calcium di(acetate),62-54-4,"Repeated dose toxicity: oral:Weight of evidence: Read-across from experimental results from no-standard studies on rats with Sodium Acetate and Citric acid, sodium salt. All these studies showed no signs of toxicity, even though in one study, the limit dose was exceeded. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04ab9e78-c601-466b-bda6-8c8417ad73bf/documents/IUC5-68236de9-eaf6-4204-898c-83ca567d938e_eec3b7de-c48b-44c0-b94a-50e8cf4a05e8.html,,,,,, Calcium di(acetate),62-54-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04ab9e78-c601-466b-bda6-8c8417ad73bf/documents/IUC5-68236de9-eaf6-4204-898c-83ca567d938e_eec3b7de-c48b-44c0-b94a-50e8cf4a05e8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"3,472 mg/kg bw/day",,rat Calcium di(acetate),62-54-4,Acute oral toxicity: Key study: The oral LD50 in female rats was 2700 mg/kg bw (test method according to OECD 401).Acute inhalation toxicity: Key study: The (4h) LC50 in male/female rats was greater than 5.6 mg/L air (test method equivalent to OECD 403).Acute dermal toxicity: Key study: Read-across from experimental data on the analogue Fumaric Acid. The LD 50 for Calcium Acetate is calculated to be greater than 27247.2 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04ab9e78-c601-466b-bda6-8c8417ad73bf/documents/IUC5-02af0e07-c31d-4526-bd90-f5ed2df674c0_eec3b7de-c48b-44c0-b94a-50e8cf4a05e8.html,,,,,, Calcium di(acetate),62-54-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04ab9e78-c601-466b-bda6-8c8417ad73bf/documents/IUC5-02af0e07-c31d-4526-bd90-f5ed2df674c0_eec3b7de-c48b-44c0-b94a-50e8cf4a05e8.html,,oral,LD50,"2,700 mg/kg bw",, Calcium di(acetate),62-54-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04ab9e78-c601-466b-bda6-8c8417ad73bf/documents/IUC5-02af0e07-c31d-4526-bd90-f5ed2df674c0_eec3b7de-c48b-44c0-b94a-50e8cf4a05e8.html,,dermal,LD50,"27,247.2 mg/kg bw",, Calcium di(acetate),62-54-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04ab9e78-c601-466b-bda6-8c8417ad73bf/documents/IUC5-02af0e07-c31d-4526-bd90-f5ed2df674c0_eec3b7de-c48b-44c0-b94a-50e8cf4a05e8.html,,inhalation,LC50,"5,600 mg/m3",, "Glass, oxide, chemicals",65997-17-3,"E-glass microfibre is assessed to possess no toxic properties after repeated oral or dermal exposure. E-glass microfibre is able to induce an inflammatory response in the lungs after inhalation exposure.The potential to induce an inflammatory response in lungs of healthy male Wistar rats following repeated inhalation exposure is documented in a study of repeated exposure for 3 months, followed by recovery periods of 1, 7, or 14 weeks, according to EC guideline ECB/TM16 (97) rev. 1, 1999. This observation is supported by a study of short-term repeated exposure for 7 hours to a fibre concentration of 1000 WHO fibres/ml air. The inflammatory response exhibits a pattern of progressively increasing level, with repeated exposure of 7 hours daily for 1 to 14 days (Searl et al 1999). The LOAEC for induction of inflammatory response in the lungs of rats exposed repeatedly for 3 months was 15 WHO fibres/ml air (Bellman et al 2003). Based on the data for repeated dose toxicity for exposure by inhalation, E-glass microfibre should be classified as holding specific target organ toxicity with repeated exposure Cat. 2 (H373) as it is able to induce an irreversible inflammatory response and fibrosis in the lungs. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b12f957f-fd51-425d-b9ff-b766b79a213b/documents/IUC5-f05eebd1-6d32-4b28-b2c6-5c0a2b8c7be4_0ca2d379-7acb-4c77-bc23-f7d662981130.html,,,,,, "Glass, oxide, chemicals",65997-17-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b12f957f-fd51-425d-b9ff-b766b79a213b/documents/IUC5-f05eebd1-6d32-4b28-b2c6-5c0a2b8c7be4_0ca2d379-7acb-4c77-bc23-f7d662981130.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,15 ,,rat "Glass, oxide, chemicals",65997-17-3,"E-glass microfibre is assessed to have no acute toxicity by ingestion, by skin contact or by inhalation. E-glass microfibre shall not be classified as an acute toxicant according to the criteria in Council Directive 67/548/EEC and Regulation (EC) 1272/2008. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b12f957f-fd51-425d-b9ff-b766b79a213b/documents/IUC5-42c07fd7-6503-46cc-ab5e-f6529bf30fcc_0ca2d379-7acb-4c77-bc23-f7d662981130.html,,,,,, Calcium didocosanoate,3578-72-1,"Dose responsive localized dermal effects at the test site (dorsal surface), consisting of scabbed post dose findings and elevated dermal scores. These findings were most pronounced at 1000 mg/kg bw/day and were seen most frequently at this dose level. The findings at 300 mg/kg bw/day were at a lower incidence and with lower dermal scores. Dermal scores and findings at 100 mg/kg bw/day were comparable to the controls. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/768270e0-089c-4afa-bda5-d7d93e116f18/documents/ad7bdac2-f925-4efd-9da1-4bb4851b6ea4_3e14b087-b105-4441-a6b9-fdd861427402.html,,,,,, Calcium didocosanoate,3578-72-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/768270e0-089c-4afa-bda5-d7d93e116f18/documents/ad7bdac2-f925-4efd-9da1-4bb4851b6ea4_3e14b087-b105-4441-a6b9-fdd861427402.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,089.75 mg/kg bw/day",,rat Calcium didocosanoate,3578-72-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/768270e0-089c-4afa-bda5-d7d93e116f18/documents/ad7bdac2-f925-4efd-9da1-4bb4851b6ea4_3e14b087-b105-4441-a6b9-fdd861427402.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,500 mg/kg bw/day",,rat Calcium didocosanoate,3578-72-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/768270e0-089c-4afa-bda5-d7d93e116f18/documents/ad7bdac2-f925-4efd-9da1-4bb4851b6ea4_3e14b087-b105-4441-a6b9-fdd861427402.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.86 mg/cm2,adverse effect observed,rat Calcium didocosanoate,3578-72-1,It is considered from the results that all the substances in the category of calcium salts of C14-C22 monocarboxylic acids exhibit a similar lack of acute oral and dermal toxicity potential across the entire category. There is no evidence of a relevant intrinsic acute oral or dermal toxicity requiring classification or substance specific RMMs. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/768270e0-089c-4afa-bda5-d7d93e116f18/documents/041bff4c-dada-486a-8ba0-f9ca88df1b10_3e14b087-b105-4441-a6b9-fdd861427402.html,,,,,, Calcium didocosanoate,3578-72-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/768270e0-089c-4afa-bda5-d7d93e116f18/documents/041bff4c-dada-486a-8ba0-f9ca88df1b10_3e14b087-b105-4441-a6b9-fdd861427402.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Calcium didocosanoate,3578-72-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/768270e0-089c-4afa-bda5-d7d93e116f18/documents/041bff4c-dada-486a-8ba0-f9ca88df1b10_3e14b087-b105-4441-a6b9-fdd861427402.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Calcium carbonate,471-34-1," Repeat dose toxicity - oral: A 14 day range finder study, a 28 day and a 90-day repeat dose oral toxicity study in rats are available that have evaluated the repeated dose toxicity of uncoated nano calcium carbonate. A 28 day study in the mouse is also available, as well as a number of human studies on bulk calcium carbonate. None of the studies described any severe or adverse toxicological effects following oral administration of the test material. Repeat dose toxicity - dermal: No studies on the repeated dose dermal toxicity of bulk calcium carbonate are available. Repeat dose toxicity - inhalation: A 90 day inhalation toxicity study in the rat is has been performed using uncoated nano calcium carbonate in which no systemic toxicity was observed. Local effects were observed in the lung, these were irritation and increased lung weights. The NOAEC was 0.212 mg/L. The results of these studies are read across to the bulk calcium carbonate. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/158755ab-6e69-42c9-840f-dadb37c39d8d/documents/262d6fcd-353c-448e-8974-e7c673234937_5ed0b8fb-ed67-4c2f-8b36-af07256ebb5d.html,,,,,, Calcium carbonate,471-34-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/158755ab-6e69-42c9-840f-dadb37c39d8d/documents/262d6fcd-353c-448e-8974-e7c673234937_5ed0b8fb-ed67-4c2f-8b36-af07256ebb5d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Calcium carbonate,471-34-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/158755ab-6e69-42c9-840f-dadb37c39d8d/documents/262d6fcd-353c-448e-8974-e7c673234937_5ed0b8fb-ed67-4c2f-8b36-af07256ebb5d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,399 mg/m3,,rat Calcium carbonate,471-34-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/158755ab-6e69-42c9-840f-dadb37c39d8d/documents/262d6fcd-353c-448e-8974-e7c673234937_5ed0b8fb-ed67-4c2f-8b36-af07256ebb5d.html,Repeated dose toxicity – local effects,inhalation,NOAEC,212 mg/m3,adverse effect observed,rabbit Calcium carbonate,471-34-1,"Bulk calcium carbonate is not considered to be acutely harmful by the oral, dermal or inhalation routes. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/158755ab-6e69-42c9-840f-dadb37c39d8d/documents/IUC5-f5e2539e-4b0a-4cdc-b689-1271493ac276_5ed0b8fb-ed67-4c2f-8b36-af07256ebb5d.html,,,,,, Calcium carbonate,471-34-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/158755ab-6e69-42c9-840f-dadb37c39d8d/documents/IUC5-f5e2539e-4b0a-4cdc-b689-1271493ac276_5ed0b8fb-ed67-4c2f-8b36-af07256ebb5d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Calcium carbonate,471-34-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/158755ab-6e69-42c9-840f-dadb37c39d8d/documents/IUC5-f5e2539e-4b0a-4cdc-b689-1271493ac276_5ed0b8fb-ed67-4c2f-8b36-af07256ebb5d.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Calcium carbonate,471-34-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/158755ab-6e69-42c9-840f-dadb37c39d8d/documents/IUC5-f5e2539e-4b0a-4cdc-b689-1271493ac276_5ed0b8fb-ed67-4c2f-8b36-af07256ebb5d.html,,inhalation,discriminating conc.,"3,000 mg/m3",no adverse effect observed, Dicalcium pyrophosphate,7790-76-3, There are currently no experimental data available to assess repeated dose toxicity for the test substance. A data waiver is set in place to justify that no further repeated dose toxicity testing is required. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00d6d188-fe5b-4e03-8b10-242518768865/documents/04cc0070-a2c1-476e-a9bc-a90c772dee1c_de4fd53b-cae0-4fcf-a550-11ffb791686c.html,,,,,, Dicalcium pyrophosphate,7790-76-3,"Oral: LD50(rat, f) > 2000 mg/kg bw (OECD 420, GLP)Inhalation: LC50(rat, m/f) > 5.09 mg/L (OECD 436, GLP)Dermal: no study available ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00d6d188-fe5b-4e03-8b10-242518768865/documents/IUC5-78c75866-adad-4bc3-989a-4f11d2556368_de4fd53b-cae0-4fcf-a550-11ffb791686c.html,,,,,, Dicalcium pyrophosphate,7790-76-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00d6d188-fe5b-4e03-8b10-242518768865/documents/IUC5-78c75866-adad-4bc3-989a-4f11d2556368_de4fd53b-cae0-4fcf-a550-11ffb791686c.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Dicalcium pyrophosphate,7790-76-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00d6d188-fe5b-4e03-8b10-242518768865/documents/IUC5-78c75866-adad-4bc3-989a-4f11d2556368_de4fd53b-cae0-4fcf-a550-11ffb791686c.html,,inhalation,discriminating conc.,"5,090 mg/m3",no adverse effect observed, Calcium chloride,10043-52-4," In accordance with column 2 of REACH Annex VIII and IX, the repeated dose toxicity studies (required under section 8.6) are not needed if a substance undergoes immediate disintegration and there are sufficient data on the cleavage products. In aqueous solution calcium chloride immediately dissociates into the ions Ca2+and Cl-, which are both essential nutrients for humans and a daily intake of more than 1000 mg for each of the ions is recommended. As for healthy humans, the tolerable upper intake level for calcium is set at 2500 mg per day (equivalent to 6.9 g CaCl2per day)[1].For chloride, the reference nutrient intake is set at 2500 mg/day (equivalent to 3.9 g CaCl2per day)[2]. The estimated intake of calcium chloride in a form of food additives (160-345 mg/day) is considerably smaller than these values. Consistent with this, the establishment of an ADI for calcium chloride has not been deemed necessary by JECFA[3]. Therefore, repeated dose toxicity studies are considered (scientifically) not necessary. There is one study for repeated dose oral toxicity in rats although the data presented in the study is not sufficient. The study shows no adverse effect of calcium chloride on rats fed 20 mg CaCl2/g diet (comparable to 1000 mg/kg bw/day or more) for 12 months. [1]Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, 1999 [2]Department of Health, UK, 1991 [3]Joint FAO/WHO Expert Committee on Food Additives; 1974, 2001 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc4a31c9-0950-4bb0-a220-3e0751f548ef/documents/656a8d15-ee06-43b0-9adc-acd4481a93f7_6ed24ef0-a414-41d3-83ae-b725f015e7ff.html,,,,,, Calcium chloride,10043-52-4," The combined oral LD50 for male and female rats, determined in a GLP-compliant guideline study, was 2301 mg/kg bw. The dermal LD50 for rabbits was above 5000 mg/kg bw. No reliable animal data on acute inhalation toxicity are available; however, human data suggest that calcium chloride is not acutely toxic by inhalation. A non-reliable acute toxicity study with rats reported signs of respiratory tract irritation at 40 and 160 mg/m3. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc4a31c9-0950-4bb0-a220-3e0751f548ef/documents/6274f2ef-92b9-4639-80ea-372b1456ec3c_6ed24ef0-a414-41d3-83ae-b725f015e7ff.html,,,,,, Calcium chloride,10043-52-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc4a31c9-0950-4bb0-a220-3e0751f548ef/documents/6274f2ef-92b9-4639-80ea-372b1456ec3c_6ed24ef0-a414-41d3-83ae-b725f015e7ff.html,,oral,LD50,"2,301 mg/kg bw",, Calcium chloride,10043-52-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc4a31c9-0950-4bb0-a220-3e0751f548ef/documents/6274f2ef-92b9-4639-80ea-372b1456ec3c_6ed24ef0-a414-41d3-83ae-b725f015e7ff.html,,dermal,LD50,"5,000 mg/kg bw",, Tricalcium dicitrate,813-94-5,"Read across from a fairly limited reliable report of a non-standard oral feeding study using citric acid in the rat, conducted without GLP compliance, identified 5-day NOAEL values in the rat of 4000 mg/kg bw/day (which corresponds to 5160 mg tri calcium dicitrate/kg (bw)/d*). (Hoffman, 1976; rel 2) In addition read across from a fairly limited reliable report of a non-standard 10 day feeding study using citric acid conducted without GLP compliance in mice and rats, identified 10-day NOAEL values in the mouse of 1000 and 4000 g/kg bw/day, (which corresponds to 1290 and 5160 mg tri calcium dicitrate /kg (bw)/d*)respectively.* based on a conversion factor of 1.29 obtained by: (Mass of one mole of salt)/(mass of citric acid produced when tricalcium dicitrate dissociates) = 498.4 / (2 * 192.9) = 1.29. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/576b612c-09f2-4ef9-9de3-46965df0abc6/documents/IUC5-6597746b-e79c-41e3-ad80-8f29a56196bd_3531bfaa-4a63-4872-8ab6-9cb6c64dbdca.html,,,,,, Tricalcium dicitrate,813-94-5,"The key study for acute oral toxicity was read across from zinc dicitrate, which report an LD50 value of 5400mg/kg (Roche, 1981; rel 2). [PLACEHOLDER FOR DERMAL TOX READ ACROSS]. Data for the acute toxicity inhalation endpoint was waived, since reliable data was available for the acute oral and dermal endpoints. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/576b612c-09f2-4ef9-9de3-46965df0abc6/documents/IUC5-e578c25e-dc42-4423-99cd-7016ee487e5b_3531bfaa-4a63-4872-8ab6-9cb6c64dbdca.html,,,,,, Tricalcium dicitrate,813-94-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/576b612c-09f2-4ef9-9de3-46965df0abc6/documents/IUC5-e578c25e-dc42-4423-99cd-7016ee487e5b_3531bfaa-4a63-4872-8ab6-9cb6c64dbdca.html,,oral,LD50,"5,400 mg/kg bw",, Calcium bis(dihydrogenorthophosphate),7758-23-8, There are currently no experimental data available to assess repeated dose toxicity for the test substance. A data waiver is set in place to justify that no further repeated dose toxicity testing is required. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92aab367-7910-4e95-8fb3-dcc419c58cfb/documents/599ba379-0d55-4722-9b68-404627975bdd_5d9dde31-0635-4936-9786-541e6aa92e71.html,,,,,, Calcium bis(dihydrogenorthophosphate),7758-23-8," Oral (similar to OECD 401, RL2), rat: LD50 > 3968 mg/kg bw for females, LD 50 > 5000 mg/kg bw for males Dermal (similar to OECD 402, RL2), rabbit: LD50 > 2000 mg/kg bw (limit test) Inhalation (OECD 403, RL1), rat: LC50 > 2.6 mg/L air (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92aab367-7910-4e95-8fb3-dcc419c58cfb/documents/IUC5-5493e0b9-c589-4e4b-8784-d7968f3255e9_5d9dde31-0635-4936-9786-541e6aa92e71.html,,,,,, Calcium bis(dihydrogenorthophosphate),7758-23-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92aab367-7910-4e95-8fb3-dcc419c58cfb/documents/IUC5-5493e0b9-c589-4e4b-8784-d7968f3255e9_5d9dde31-0635-4936-9786-541e6aa92e71.html,,oral,LD50,"3,986 mg/kg bw",adverse effect observed, Calcium bis(dihydrogenorthophosphate),7758-23-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92aab367-7910-4e95-8fb3-dcc419c58cfb/documents/IUC5-5493e0b9-c589-4e4b-8784-d7968f3255e9_5d9dde31-0635-4936-9786-541e6aa92e71.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Calcium bis(dihydrogenorthophosphate),7758-23-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92aab367-7910-4e95-8fb3-dcc419c58cfb/documents/IUC5-5493e0b9-c589-4e4b-8784-d7968f3255e9_5d9dde31-0635-4936-9786-541e6aa92e71.html,,inhalation,LC50,"2,600 mg/m3",no adverse effect observed, Sodium calcium edetate,62-33-9,"Four repeated oral toxicity studies were available for EDTA-CaNa2; results of these studies were compared with studies with other metal chelates and with EDTA (see below). One repeated inhalation toxicity study was avalaible for DTPA-CaNa3, another Ca-containing chelate. Several ip and iv studies were also available showing various effects but mostly on kidneys. However, as workers and consumers are not exposed via these non-physiological routes these studies are not further taken into account. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65ddb8ca-fa37-432b-86db-93d7012ad752/documents/IUC5-59ea3137-3690-4f6e-b4c5-68f539339414_4d1eee83-8767-4a59-9c9c-cd7ea2aedae5.html,,,,,, Sodium calcium edetate,62-33-9,"The LD50 value in rats was ca. 10 g/kg bw; the LD50 value in rabbits was ca. 7 g/kg bw and the LD50 in dogs ca. 12 g/kg bw, the 7-h LC50 value was in excess of 1.13 mg/L (nominal). Non-physiological routes of exposure (iv and ip) also showed low acute toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65ddb8ca-fa37-432b-86db-93d7012ad752/documents/IUC5-4098cfbd-8613-417d-a924-29b5c096558f_4d1eee83-8767-4a59-9c9c-cd7ea2aedae5.html,,,,,, Calcium dodecylbenzenesulphonate,26264-06-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31a672ed-8b49-48c8-8035-a2c34a6e30de/documents/IUC5-a7fcfc49-0cd4-452a-ac1b-b72aef3c70e0_6f68288c-0144-449d-a738-bdb541a724ee.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Calcium dodecylbenzenesulphonate,26264-06-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31a672ed-8b49-48c8-8035-a2c34a6e30de/documents/IUC5-a7fcfc49-0cd4-452a-ac1b-b72aef3c70e0_6f68288c-0144-449d-a738-bdb541a724ee.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,286 mg/kg bw/day,,rat Calcium dodecylbenzenesulphonate,26264-06-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31a672ed-8b49-48c8-8035-a2c34a6e30de/documents/IUC5-a7fcfc49-0cd4-452a-ac1b-b72aef3c70e0_6f68288c-0144-449d-a738-bdb541a724ee.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,4.35 mg/m3,,rat Calcium dodecylbenzenesulphonate,26264-06-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31a672ed-8b49-48c8-8035-a2c34a6e30de/documents/IUC5-a7fcfc49-0cd4-452a-ac1b-b72aef3c70e0_6f68288c-0144-449d-a738-bdb541a724ee.html,Repeated dose toxicity – local effects,dermal,NOAEL,1.6 mg/cm2,no adverse effect observed,rat Calcium dodecylbenzenesulphonate,26264-06-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31a672ed-8b49-48c8-8035-a2c34a6e30de/documents/IUC5-a7fcfc49-0cd4-452a-ac1b-b72aef3c70e0_6f68288c-0144-449d-a738-bdb541a724ee.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4.35 mg/m3,no adverse effect observed,rat Calcium dodecylbenzenesulphonate,26264-06-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31a672ed-8b49-48c8-8035-a2c34a6e30de/documents/IUC5-5ed0cb99-6eb0-43da-8467-ee71fd25bbaa_6f68288c-0144-449d-a738-bdb541a724ee.html,,oral,LD50,"1,300 mg/kg bw",adverse effect observed, Calcium dodecylbenzenesulphonate,26264-06-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31a672ed-8b49-48c8-8035-a2c34a6e30de/documents/IUC5-5ed0cb99-6eb0-43da-8467-ee71fd25bbaa_6f68288c-0144-449d-a738-bdb541a724ee.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Calcium dodecylbenzenesulphonate,26264-06-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31a672ed-8b49-48c8-8035-a2c34a6e30de/documents/IUC5-5ed0cb99-6eb0-43da-8467-ee71fd25bbaa_6f68288c-0144-449d-a738-bdb541a724ee.html,,inhalation,LC50,310 mg/m3,no adverse effect observed, Calcium fluoride,7789-75-5," The results of studies of repeated dose oral toxicity indicate that calcium fluoride exhibits typical fluoride toxicity, however the low water solubility of the substance indicates that the oral bioavailability of fluoride from the substance is less than other salts such as sodium fluoride, thereby limiting its toxicity. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d82d78bc-952a-4639-85c0-d9dd9190697d/documents/a1894f06-f789-47f1-92f3-d400146df5f4_6579b53a-065b-43f5-bba4-dc070149fb70.html,,,,,, Calcium fluoride,7789-75-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d82d78bc-952a-4639-85c0-d9dd9190697d/documents/a1894f06-f789-47f1-92f3-d400146df5f4_6579b53a-065b-43f5-bba4-dc070149fb70.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,1.2 mg/kg bw/day,,mouse Calcium fluoride,7789-75-5," Acute oral toxicity: The key acute oral toxicity study on calcium difluoride yielded an LD50 > 2000 mg CaF2/kg bw/d in rats. Acute dermal toxicity No acute dermal toxicity study on calcium difluoride is available. Dermal acute toxicit information is however available for read-across source substance sodium fluoride (NaF). The dermal LD50 of NaF is found to be > 2000 mg NaF/kg bw/d in rats. As a consequence, it can be reasonably expected that the dermal acute toxicity of calcium difluoride is low too. Acute inhalation toxicity The key acute inhalation toxicity study on calcium difluoride yielded an inhalation LC50 of 5070 mg CaF2/m3. Conclusion: The substance is of low acute toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d82d78bc-952a-4639-85c0-d9dd9190697d/documents/12e0c989-b82e-47aa-a333-c852c6790cb3_6579b53a-065b-43f5-bba4-dc070149fb70.html,,,,,, Calcium fluoride,7789-75-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d82d78bc-952a-4639-85c0-d9dd9190697d/documents/12e0c989-b82e-47aa-a333-c852c6790cb3_6579b53a-065b-43f5-bba4-dc070149fb70.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Calcium fluoride,7789-75-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d82d78bc-952a-4639-85c0-d9dd9190697d/documents/12e0c989-b82e-47aa-a333-c852c6790cb3_6579b53a-065b-43f5-bba4-dc070149fb70.html,,inhalation,LC50,"5,070 mg/m3",no adverse effect observed, Calcium glycerophosphate,27214-00-2, Introduction The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat. Methods A group of three fasted females was treated with the test item at a dose level of 2000 mg/kg body weight. This was followed by a further group of three fasted females at the same dose level. Dosing was performed sequentially. The test item was administered orally as a suspension in arachis oil BP. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. Results Mortality. There were no deaths. Clinical Observations. There were no signs of systemic toxicity. Body Weight. All animals showed expected gains in body weight. Necropsy. No abnormalities were noted at necropsy. Conclusion The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg body weight (Globally Harmonized Classification System - Unclassified). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a132e560-c7a3-4376-86d2-0ea7643ac790/documents/12923399-1c69-424f-9d99-4e33a6dacf7d_933c8e9f-9e3f-4c34-b4c1-81511bcbf468.html,,,,,, Calcium glycerophosphate,27214-00-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a132e560-c7a3-4376-86d2-0ea7643ac790/documents/12923399-1c69-424f-9d99-4e33a6dacf7d_933c8e9f-9e3f-4c34-b4c1-81511bcbf468.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Calcium dihydroxide,1305-62-0," Toxicity of calcium via the oral route is addressed by upper intake levels (UL) for adults determined by the Scientific Committee on Food (SCF), being UL = 2500 mg/d, corresponding to 36 mg/kg bw/d (70 kg person) for calcium. Toxicity of calcium dihydroxide via the dermal route is not considered as relevant in view of the anticipated negligible absorption through skin. Toxicity of calcium dihydroxide via inhalation (local effect, irritation of mucous membranes) is addressed by an IOELV of 1 mg/m³ respirable fraction (8h-TWA) (Commission Directive (EU) 2017/164 of 31 January 2017). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6e8b4cd-2ef5-4bd5-8529-f02a802e0964/documents/fce784e8-9f55-493d-9ba6-91fad7aa416a_d6494ffe-c2d1-4ec8-a776-31ce3ca22e17.html,,,,,, Calcium dihydroxide,1305-62-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6e8b4cd-2ef5-4bd5-8529-f02a802e0964/documents/fce784e8-9f55-493d-9ba6-91fad7aa416a_d6494ffe-c2d1-4ec8-a776-31ce3ca22e17.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,107 mg/m3,,rat Calcium dihydroxide,1305-62-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6e8b4cd-2ef5-4bd5-8529-f02a802e0964/documents/fce784e8-9f55-493d-9ba6-91fad7aa416a_d6494ffe-c2d1-4ec8-a776-31ce3ca22e17.html,Repeated dose toxicity – local effects,inhalation,NOAEC,107 mg/m3,no adverse effect observed,rat Calcium dihydroxide,1305-62-0,"Acute oral toxicity: LD50 (rat) > 2000 mg/kg bw for calcium dihydroxide (Arcelin, 2007)LD50 (rat) > 2000 mg/kg bw for calcium carbonate (Bradshaw, 2008)Acute inhalation toxicity:4-h LC50 (rat) >6.04 mg/L air for calcium dihydroxide, based on read-across to Flue dust, Portland cement (EC 270-659-9)(TNO, 2010)4-h LC50 (rat) >3 mg/L air (highest technically achievable concentration) for calcium carbonate (Schuler, 2010)Acute dermal toxicity:LD50 (rabbit) > 2500 mg/kg bw for calcium dihydroxide (Kietzmann, 1994)LD50 (rat) > 2000 mg/kg bw for calcium carbonate (Bradshaw, 2010) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6e8b4cd-2ef5-4bd5-8529-f02a802e0964/documents/IUC5-08192d00-9a1f-4534-a45b-92ad2688b760_d6494ffe-c2d1-4ec8-a776-31ce3ca22e17.html,,,,,, Calcium dihydroxide,1305-62-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6e8b4cd-2ef5-4bd5-8529-f02a802e0964/documents/IUC5-08192d00-9a1f-4534-a45b-92ad2688b760_d6494ffe-c2d1-4ec8-a776-31ce3ca22e17.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Calcium dihydroxide,1305-62-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6e8b4cd-2ef5-4bd5-8529-f02a802e0964/documents/IUC5-08192d00-9a1f-4534-a45b-92ad2688b760_d6494ffe-c2d1-4ec8-a776-31ce3ca22e17.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, Calcium dihydroxide,1305-62-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6e8b4cd-2ef5-4bd5-8529-f02a802e0964/documents/IUC5-08192d00-9a1f-4534-a45b-92ad2688b760_d6494ffe-c2d1-4ec8-a776-31ce3ca22e17.html,,inhalation,discriminating conc.,"6,040 mg/m3",adverse effect observed, Calcium hypochlorite,7778-54-3,"Repeated dose toxicity.Oral. Key study (Anonymous). Test method similar to OECD 407. A NOAEC of>7500 ppm avCI was determined.  Repeated dose toxicity.Oral. Key study (Hasegawa). Test method similar to OECD 408. A LO(A)EL 0.2 %, corresponding to 100 mg/kg bw/d (males) and 114.4 mg/kg bw/d (females) and a NO(A)EL 0.1 %, corresponding to 50 mg/kg bw/d (males) and 57.2 mg/kg bw/d (females) (assuming a water consumption of 25 mL/day for a rat and a body weight of 500 and 350g) were determined. Repeated dose toxicity.Oral. Key study (Daniel, 1990). Test method similar to OECD 408. A LO(A)EL > 250 mg/L (16.7 mg/kg bw/d males; 24.9 mg/kg bw/d females) NO(A)EL ≥ 250 mg/L (16.7 mg/kg bw/d males; 24.9 mg/kg bw/d females) were determined. Repeated dose toxicity.Oral. Key study (Daniel, 1991). Test method similar to OECD 408. A LO(A)EL > 34.4 mg/kg bw/day NO(A)EL ≥ 34.4 mg/kg bw/day were determined. Repeated dose toxicity.Oral. Key study (NTP, 1992, mice). Test method similar to OECD 453. A NO(A)EL> 275 ppm (45.8 mg/kg bw/d for males and 55 mg/kg bw/d for females) was determined. Repeated dose toxicity.Oral. Key study (NTP, 1992, rat). Test method similar to OECD 453. A NO(A)EL> 275 ppm (13.75 mg/kg bw/d for males and 15.7 mg/kg bw/d for females) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4637f10-296d-4736-9af2-0f3a8f5c98ed/documents/90efb12a-0b24-486b-9eb3-8b902928bcfb_c8a7757c-1b2d-4beb-bde2-81a387253f12.html,,,,,, Calcium hypochlorite,7778-54-3,"Acute oral toxicity: Key study. Test method mainly accoding to to OECD 401. The LD50 of the test item is 0.85 g/kg bw=850 mg/kg bw (<2000 mg/kg) by oral route in the rat. Acute inhalation toxicity: Key study. Under the conditions of this study, the 4-hour LC50 for test item was calculated to be 0.51 mg/L (with 95 % confidence limits of 0.43-0.79 mg/L). Acute dermal toxicity: Key study. Under the conditions of this study, the dermal LD50 for test item was determined to be >2 g/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4637f10-296d-4736-9af2-0f3a8f5c98ed/documents/134fece3-f3ae-4b6b-b841-95d609d8813a_c8a7757c-1b2d-4beb-bde2-81a387253f12.html,,,,,, Calcium hypochlorite,7778-54-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4637f10-296d-4736-9af2-0f3a8f5c98ed/documents/134fece3-f3ae-4b6b-b841-95d609d8813a_c8a7757c-1b2d-4beb-bde2-81a387253f12.html,,oral,LD50,850 mg/kg bw,adverse effect observed, Calcium hypochlorite,7778-54-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4637f10-296d-4736-9af2-0f3a8f5c98ed/documents/134fece3-f3ae-4b6b-b841-95d609d8813a_c8a7757c-1b2d-4beb-bde2-81a387253f12.html,,dermal,,"> 2,000 mg/kg bw",no adverse effect observed, Calcium hypochlorite,7778-54-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4637f10-296d-4736-9af2-0f3a8f5c98ed/documents/134fece3-f3ae-4b6b-b841-95d609d8813a_c8a7757c-1b2d-4beb-bde2-81a387253f12.html,,inhalation,LC50,510 mg/m3,adverse effect observed, Calcium dilactate,814-80-2,"Repeated-dose toxicity should be considered a non-relevant end point for a biochemically essential substance, at least in the framework of normal toxicological testing. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f728f95a-20f6-4258-b6bf-5c8372d7f83e/documents/IUC5-cd3c6029-0663-43ab-ba64-a86837e5f622_2021704c-df85-4fdf-99f1-15c0201affc6.html,,,,,, Calcium dilactate,814-80-2,"Calcium lactate fully dissociates into Ca2+ ions and lactate. The toxicological effects of lactate can be understood in terms of the toxicological effect of lactic acid. Calcium ions - i.e. simple calcium salts, are non-toxic.Despite being irritating to abraded rabbit skin, lactic acid is practically non-toxic by the oral, inhalation and dermal route. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f728f95a-20f6-4258-b6bf-5c8372d7f83e/documents/IUC5-d5af8bd3-176b-4fce-aa38-fcab7241abdb_2021704c-df85-4fdf-99f1-15c0201affc6.html,,,,,, Calcium dilactate,814-80-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f728f95a-20f6-4258-b6bf-5c8372d7f83e/documents/IUC5-d5af8bd3-176b-4fce-aa38-fcab7241abdb_2021704c-df85-4fdf-99f1-15c0201affc6.html,,oral,LD50,"4,290 mg/kg bw",, Calcium dilactate,814-80-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f728f95a-20f6-4258-b6bf-5c8372d7f83e/documents/IUC5-d5af8bd3-176b-4fce-aa38-fcab7241abdb_2021704c-df85-4fdf-99f1-15c0201affc6.html,,dermal,LD50,"2,420 mg/kg bw",, Calcium dilactate,814-80-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f728f95a-20f6-4258-b6bf-5c8372d7f83e/documents/IUC5-d5af8bd3-176b-4fce-aa38-fcab7241abdb_2021704c-df85-4fdf-99f1-15c0201affc6.html,,inhalation,LC50,"7,400 mg/m3",, Calcium oxide,1305-78-8," Toxicity of calcium via the oral route is addressed by upper intake levels (UL) for adults determined by the Scientific Committee on Food (SCF), being UL = 2500 mg/d, corresponding to 36 mg/kg bw/d (70 kg person) for calcium. Toxicity of calcium oxide via the dermal route is not considered as relevant in view of the anticipated negligible absorption through skin. Toxicity of calcium oxide via inhalation (local effect, irritation of mucous membranes) is addressed by an IOELV of 1 mg/m³ respirable fraction (8h-TWA) (Commission Directive (EU) 2017/164 of 31 January 2017). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67bac592-cb4c-4b32-86cb-e0ffcda0e1ff/documents/46dfaecc-2264-4b30-acb8-e50cce1f5074_67066073-1242-43d8-80b0-6f7fecfab519.html,,,,,, Calcium oxide,1305-78-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67bac592-cb4c-4b32-86cb-e0ffcda0e1ff/documents/46dfaecc-2264-4b30-acb8-e50cce1f5074_67066073-1242-43d8-80b0-6f7fecfab519.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,107 mg/m3,,rat Calcium oxide,1305-78-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67bac592-cb4c-4b32-86cb-e0ffcda0e1ff/documents/46dfaecc-2264-4b30-acb8-e50cce1f5074_67066073-1242-43d8-80b0-6f7fecfab519.html,Repeated dose toxicity – local effects,inhalation,NOAEC,107 mg/m3,no adverse effect observed,rat Calcium oxide,1305-78-8,CaO is not acutely toxic. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67bac592-cb4c-4b32-86cb-e0ffcda0e1ff/documents/IUC5-cc59278d-5231-4d98-b920-65051931343f_67066073-1242-43d8-80b0-6f7fecfab519.html,,,,,, Calcium oxide,1305-78-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67bac592-cb4c-4b32-86cb-e0ffcda0e1ff/documents/IUC5-cc59278d-5231-4d98-b920-65051931343f_67066073-1242-43d8-80b0-6f7fecfab519.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Calcium oxide,1305-78-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67bac592-cb4c-4b32-86cb-e0ffcda0e1ff/documents/IUC5-cc59278d-5231-4d98-b920-65051931343f_67066073-1242-43d8-80b0-6f7fecfab519.html,,inhalation,discriminating conc.,"6,040 mg/m3",adverse effect observed, Calcium dipropionate,4075-81-4,"No repeated dose toxicity study with calcium dipropionate is available, thus the repeated dose toxicity will be addressed with existing data on the individual dissociation products calcium and propionic acid. In relevant and reliable repeated dose toxicity studies for both dissociation products of calcium dipropionate, there were no toxicological findings reported that would justify a classification. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfbcb7c5-27f8-41a8-9d9f-f73d77b29717/documents/IUC5-cd7cb678-5cb1-4c7d-a992-472dc0737998_af1e60d9-272b-45b7-a4e6-6c7d4417599f.html,,,,,, Calcium dipropionate,4075-81-4,"In a GLP conform OECD 423 study, the acute oral LD50 value of the test item Calcium dipropionate was found to be > 2000 mg/kg bw in female Han:WIST rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfbcb7c5-27f8-41a8-9d9f-f73d77b29717/documents/IUC5-e690ba3d-359d-498c-a509-e2fa0cba107a_af1e60d9-272b-45b7-a4e6-6c7d4417599f.html,,,,,, Calcium dipropionate,4075-81-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfbcb7c5-27f8-41a8-9d9f-f73d77b29717/documents/IUC5-e690ba3d-359d-498c-a509-e2fa0cba107a_af1e60d9-272b-45b7-a4e6-6c7d4417599f.html,,oral,LD50,"> 2,000 mg/kg bw",adverse effect observed, "Silicic acid, calcium salt",1344-95-2,"Oral: Subchronic (90-day, OECD 408): NOAEL = 1000 mg/kg bw/day Chronic (24-month, similar OECD 452): NOAEL = 2500 - 3200 mg/kg bw/day (corresponding to 5% in diet)   Inhalation: Subacute (28-day, OECD 412): NOEC = 11.3 mg/m3 air Subacute (28-day, similar OECD 412): LOEC (female) = 121 mg/m3 air Subchronic (90-day, OECD 413): NOAEC (systemic toxicity) = 5 mg/m3 air, LOAEC (nasal cavities) = 1 mg/m3 air (data obtained with analogue substance CAS 7631-86-9) Chronic (22-month, no guideline): NOAEC ca. 124 mg/m3 air   In a subchronic (90-day) repeated dose toxicity study, calcium silicate produced no relevant biological effects. The No-Observed-Adverse-Effect-Level (NOAEL) was determined to be 1000 mg/kg bw/day. In a 2-y feeding study, calcium silicate produced no significant adverse effects. Inhalation exposure to calcium silicate: Target organ is the lung. Based on results from synthetic amorphous silica (SAS), the parent substance, low exposure concentration of respirable dust particles provokes an inflammation response, which is reversible. No histopathological manifestations following exposure of 13 weeks to 1.3 mg/m3. An experimental NOAEC (acute to subchronic) of 1 mg/m3 (respirable) was established for SAS aerosol.   Available and suitable data on the source substance silicon dioxide (CAS 7631-86-9) was taken into account by read-across following a structural analogue approach. A detailed rationale and justification for the analogue read-across approach is provided in the technical dossier (see IUCLID section 13). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8943e1f5-6591-4fb5-88f5-9ced3c9cb08a/documents/IUC5-58ea5f79-ce17-4c83-b204-789f9e7dc907_3b05a486-6f95-403d-aee2-ca667ef48420.html,,,,,, "Silicic acid, calcium salt",1344-95-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8943e1f5-6591-4fb5-88f5-9ced3c9cb08a/documents/IUC5-58ea5f79-ce17-4c83-b204-789f9e7dc907_3b05a486-6f95-403d-aee2-ca667ef48420.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,11.3 mg/m3,, "Silicic acid, calcium salt",1344-95-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8943e1f5-6591-4fb5-88f5-9ced3c9cb08a/documents/IUC5-58ea5f79-ce17-4c83-b204-789f9e7dc907_3b05a486-6f95-403d-aee2-ca667ef48420.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Silicic acid, calcium salt",1344-95-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8943e1f5-6591-4fb5-88f5-9ced3c9cb08a/documents/IUC5-58ea5f79-ce17-4c83-b204-789f9e7dc907_3b05a486-6f95-403d-aee2-ca667ef48420.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,5 mg/m3,,rat "Silicic acid, calcium salt",1344-95-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8943e1f5-6591-4fb5-88f5-9ced3c9cb08a/documents/IUC5-58ea5f79-ce17-4c83-b204-789f9e7dc907_3b05a486-6f95-403d-aee2-ca667ef48420.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1 mg/m3,adverse effect observed,rat "Silicic acid, calcium salt",1344-95-2,"Oral (OECD 401): LD50 (rat, m/f) > 5000 mg/kg bw (data obtained with analogue substance CAS 7631-86-9) Oral (similar OECD 401): LD50 (rat, m/f) > 10000 mg/kg bw Oral (no guideline): LD50 (rat, m) > 5000 mg/kg bw   Inhalation (OECD 436): LC50 (rat, m/f, 4 h) > 5.01 mg/L air (data obtained with analogue substance CAS 7631-86-9) Inhalation (similar OECD 403): LC50 (rat, m/f, 4 h) > 0.69 mg/L air (data obtained with analogue substance CAS 7631-86-9)   The acute oral administration of ≥ 5000 mg calcium silicate/kg bw failed to produce signs of toxicity or deaths in treated animals. Based on structure analogy to SAS, the acute inhalation of Ca silica dust may cause discomfort and dyspnea as well as transient signs of local irritation to nasal, bronchiolar and ocular mucous membranes.   Available and suitable data on the source substance silicon dioxide (CAS 7631-86-9) was taken into account by read-across following a structural analogue approach. A detailed rationale and justification for the analogue read-across approach is provided in the technical dossier (see IUCLID section 13). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8943e1f5-6591-4fb5-88f5-9ced3c9cb08a/documents/IUC5-2405dc02-12b2-4ef7-a90f-9511978aa4a8_3b05a486-6f95-403d-aee2-ca667ef48420.html,,,,,, Calcium distearate,1592-23-0,"Dose responsive localized dermal effects at the test site (dorsal surface), consisting of scabbed post dose findings and elevated dermal scores. These findings were most pronounced at 1000 mg/kg bw/day and were seen most frequently at this dose level. The findings at 300 mg/kg bw/day were at a lower incidence and with lower dermal scores. Dermal scores and findings at 100 mg/kg bw/day were comparable to the controls. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b95fc44-0807-45f2-9904-2c0703aabcf8/documents/ad7bdac2-f925-4efd-9da1-4bb4851b6ea4_b2ea6919-f408-4e13-92b4-7ec8216baab2.html,,,,,, Calcium distearate,1592-23-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b95fc44-0807-45f2-9904-2c0703aabcf8/documents/ad7bdac2-f925-4efd-9da1-4bb4851b6ea4_b2ea6919-f408-4e13-92b4-7ec8216baab2.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,089.75 mg/kg bw/day",,rat Calcium distearate,1592-23-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b95fc44-0807-45f2-9904-2c0703aabcf8/documents/ad7bdac2-f925-4efd-9da1-4bb4851b6ea4_b2ea6919-f408-4e13-92b4-7ec8216baab2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,500 mg/kg bw/day",,rat Calcium distearate,1592-23-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b95fc44-0807-45f2-9904-2c0703aabcf8/documents/ad7bdac2-f925-4efd-9da1-4bb4851b6ea4_b2ea6919-f408-4e13-92b4-7ec8216baab2.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.86 mg/cm2,adverse effect observed,rat Calcium distearate,1592-23-0,It is considered from the results that all the substances in the category of calcium salts of C14-C22 monocarboxylic acids exhibit a similar lack of acute oral and dermal toxicity potential across the entire category. There is no evidence of a relevant intrinsic acute oral or dermal toxicity requiring classification or substance specific RMMs. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b95fc44-0807-45f2-9904-2c0703aabcf8/documents/041bff4c-dada-486a-8ba0-f9ca88df1b10_b2ea6919-f408-4e13-92b4-7ec8216baab2.html,,,,,, Calcium distearate,1592-23-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b95fc44-0807-45f2-9904-2c0703aabcf8/documents/041bff4c-dada-486a-8ba0-f9ca88df1b10_b2ea6919-f408-4e13-92b4-7ec8216baab2.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Calcium distearate,1592-23-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b95fc44-0807-45f2-9904-2c0703aabcf8/documents/041bff4c-dada-486a-8ba0-f9ca88df1b10_b2ea6919-f408-4e13-92b4-7ec8216baab2.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Calcium tartrate,3164-34-9,Tartaric acid and its salts do not have significant (sub)chronic toxicity. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff4b3580-f931-45f8-bdb7-4509d6e238f6/documents/2a8c1329-dfda-44d6-9ceb-0698a75276c1_b9916f74-78f2-4dcb-b09c-f29057cf8eaf.html,,,,,, Calcium tartrate,3164-34-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff4b3580-f931-45f8-bdb7-4509d6e238f6/documents/2a8c1329-dfda-44d6-9ceb-0698a75276c1_b9916f74-78f2-4dcb-b09c-f29057cf8eaf.html,Chronic toxicity – systemic effects,oral,NOAEL,"2,460 mg/kg bw/day",,rat Calcium tartrate,3164-34-9,Tartaric acid and its salts does not have significant acute toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff4b3580-f931-45f8-bdb7-4509d6e238f6/documents/d04fce80-e023-401f-9296-ffc13b985da3_b9916f74-78f2-4dcb-b09c-f29057cf8eaf.html,,,,,, Calcium tartrate,3164-34-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff4b3580-f931-45f8-bdb7-4509d6e238f6/documents/d04fce80-e023-401f-9296-ffc13b985da3_b9916f74-78f2-4dcb-b09c-f29057cf8eaf.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Calcium sulphidoacetate,29820-13-1,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyInformation.KeyInformation): No reliable data is available on the repeated dose toxicity of calcium thioglycolate. However, the subchronic toxicity of sodium thioglycolate was evaluated by oral and dermal administrations. Based on the results of the source substance, the subchronic oral NOAEL is determined to be 32.28 mg/kg bw/day, while the dermal subchronic NOAEL is determined to be >=290 mg/kg bw/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): adequate and valid ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f92492b-4873-413b-9ae9-a82b053e1aa4/documents/87b2f0d0-e209-4e8c-b39b-0b6eaa99d28c_b27f35dd-f638-4b8c-ae6b-aa26c4fc70d6.html,,,,,, Calcium sulphidoacetate,29820-13-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f92492b-4873-413b-9ae9-a82b053e1aa4/documents/87b2f0d0-e209-4e8c-b39b-0b6eaa99d28c_b27f35dd-f638-4b8c-ae6b-aa26c4fc70d6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,32.28 mg/kg bw/day,,rat Calcium sulphidoacetate,29820-13-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f92492b-4873-413b-9ae9-a82b053e1aa4/documents/87b2f0d0-e209-4e8c-b39b-0b6eaa99d28c_b27f35dd-f638-4b8c-ae6b-aa26c4fc70d6.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,290.6 mg/kg bw/day,,rat Calcium sulphidoacetate,29820-13-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f92492b-4873-413b-9ae9-a82b053e1aa4/documents/87b2f0d0-e209-4e8c-b39b-0b6eaa99d28c_b27f35dd-f638-4b8c-ae6b-aa26c4fc70d6.html,Repeated dose toxicity – local effects,dermal,LOAEL,63 ,adverse effect observed, Calcium sulphidoacetate,29820-13-1,CaTG is toxic by ingestion. In contact with skin and by inhalation CaTG can cause irritating effects. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f92492b-4873-413b-9ae9-a82b053e1aa4/documents/4847ac27-4a10-49ef-80aa-8bda19bb6bd1_b27f35dd-f638-4b8c-ae6b-aa26c4fc70d6.html,,,,,, Calcium sulphidoacetate,29820-13-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f92492b-4873-413b-9ae9-a82b053e1aa4/documents/4847ac27-4a10-49ef-80aa-8bda19bb6bd1_b27f35dd-f638-4b8c-ae6b-aa26c4fc70d6.html,,oral,LD50,245 mg/kg bw,adverse effect observed, Calcium sulphidoacetate,29820-13-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f92492b-4873-413b-9ae9-a82b053e1aa4/documents/4847ac27-4a10-49ef-80aa-8bda19bb6bd1_b27f35dd-f638-4b8c-ae6b-aa26c4fc70d6.html,,dermal,LD50,"1,389 mg/kg bw",adverse effect observed, Calcium sulphidoacetate,29820-13-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f92492b-4873-413b-9ae9-a82b053e1aa4/documents/4847ac27-4a10-49ef-80aa-8bda19bb6bd1_b27f35dd-f638-4b8c-ae6b-aa26c4fc70d6.html,,inhalation,LC50,"1,896 mg/m3",adverse effect observed, Calcium titanium trioxide,12049-50-2," A study was performed for calcium titanium trioxide to evaluate potential acute toxicity via the oral route from a single dose in female Wistar Han™ (sub-strain: RccHan™: WIST) rats. The experimental results are considered to be a suitable predictor of toxicity by the oral route in humans. The study was carried out according to Good Laboratory Practise (GLP), OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method), and EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure) of Commission Regulation (EC) No. 440/2008. A fixed-dose procedure was followed and no deviation from the protocols was reported. Administration of calcium titanium trioxide was by oral gavage at a dose volume of 10 mL/kg using arachis oil BP as a vehicle. An initial sighting test was performed to determine an initial dose level for the main test that would produce some signs of toxicity but without causing severely toxic effects or mortality. Doses levels of 300 and 2000 mg/kg were administered as part of the sighting test to a single animal per dose level investigated and all animals were observed for a minimum of fourteen days. As no mortality was observed during the sighting experiment, the main test was conducted at a dose level of 2000 mg/kg using a group of five animals. After a 14-day observation period, no mortality was found in the group of five female rats as part of the main test. In addition, there were no signs of systemic toxicity, weight gain above that expected, nor abnormalities at necropsy. The LD50 of calcium titanium trioxide was subsequently determined to be >2000 mg/kg. The substance does not meet the criteria for classification according to Regulation 1272/2008. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43d91d27-81d1-4fd4-b2f5-ca42987f37cf/documents/4a7b368f-b95d-4a81-bc9d-6df62466604f_97c576ff-c035-41cf-8174-2a662772ef76.html,,,,,, Calcium titanium trioxide,12049-50-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43d91d27-81d1-4fd4-b2f5-ca42987f37cf/documents/4a7b368f-b95d-4a81-bc9d-6df62466604f_97c576ff-c035-41cf-8174-2a662772ef76.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Camphene,79-92-5,"Repeated dose toxicity: oral: Key study: For female rats the NOEL was 250 mg / kg bw/day. For male rats, the NOEL could not be determined (it was lower than 62.5 mg/kg bw/day). Test method was according to OECD guideline 407 and GLP. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/84e46617-2751-4bcc-904f-9291b7e5fed6/documents/IUC5-ffcedb97-787b-4db3-b0f1-c453320ba9a1_7d74a878-6293-4957-951c-45795acc5ebf.html,,,,,, Camphene,79-92-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/84e46617-2751-4bcc-904f-9291b7e5fed6/documents/IUC5-ffcedb97-787b-4db3-b0f1-c453320ba9a1_7d74a878-6293-4957-951c-45795acc5ebf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,62.5 mg/kg bw/day,,rat Camphene,79-92-5,"Acute toxicity: oral: Weight of evidence: Experimental results from different independent sources in two species (rat and mouse) and read-across from the analogue 5-ethylidene-8,9,10-trinorborn-2-ene (experimental results from different independent sources). The acute oral LD50 value is always reported to be greater than 2000 mg/kg bw.Acute toxicity: dermal: Weight of evidence: Experimental results from different independent sources in rabbits and read-across from the analogue 5-ethylidene-8,9,10-trinorborn-2-ene. A route-to-route extrapolation from the oral to the dermal route is also provided. The acute dermal LD50 value is always reported to be greater than 2000 mg/kg bw.Acute toxicity: inhalation: key study: Based on available guidelines on route-to-route extrapolation of toxicity data when assessing health risks of chemicals, an extrapolation based on the acute oral toxicity data is calculated for the inhalation route. The 4 -h LC50 would be greater than 25 mg/l. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84e46617-2751-4bcc-904f-9291b7e5fed6/documents/IUC5-e6777b63-e5b3-40a6-840e-1b0abb21f264_7d74a878-6293-4957-951c-45795acc5ebf.html,,,,,, (+)-bornan-2-one,464-49-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): the result is reliable ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/384ddff5-c740-4323-b36e-1bed328a7a9d/documents/7330ef0a-1fe0-4e2f-a4fb-879b46da98c3_35535c93-fdc8-4772-8340-1c0865db48ed.html,,,,,, (+)-bornan-2-one,464-49-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/384ddff5-c740-4323-b36e-1bed328a7a9d/documents/7330ef0a-1fe0-4e2f-a4fb-879b46da98c3_35535c93-fdc8-4772-8340-1c0865db48ed.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,250 mg/kg bw/day,,rat (+)-bornan-2-one,464-49-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): peer-reviewed Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): peer-reviewed ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/384ddff5-c740-4323-b36e-1bed328a7a9d/documents/088357f7-53cd-414c-928f-d6c4fccdcbb0_35535c93-fdc8-4772-8340-1c0865db48ed.html,,,,,, (+)-bornan-2-one,464-49-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/384ddff5-c740-4323-b36e-1bed328a7a9d/documents/088357f7-53cd-414c-928f-d6c4fccdcbb0_35535c93-fdc8-4772-8340-1c0865db48ed.html,,oral,LD50,"1,310 mg/kg bw",adverse effect observed, (+)-bornan-2-one,464-49-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/384ddff5-c740-4323-b36e-1bed328a7a9d/documents/088357f7-53cd-414c-928f-d6c4fccdcbb0_35535c93-fdc8-4772-8340-1c0865db48ed.html,,inhalation,LC50,500 mg/m3,adverse effect observed, Bornan-2-one,76-22-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): the result is reliable ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86130f44-869d-4aa8-8ca3-10877c9a127d/documents/IUC5-05370a7b-d25c-40ee-ba48-c8a178856cd9_1c3e964d-8524-44a9-871d-9c93a37e0873.html,,,,,, Bornan-2-one,76-22-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86130f44-869d-4aa8-8ca3-10877c9a127d/documents/IUC5-05370a7b-d25c-40ee-ba48-c8a178856cd9_1c3e964d-8524-44a9-871d-9c93a37e0873.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,250 mg/kg bw/day,,rat DL-6-oxobornane-10-sulphonic acid,5872-08-2,No data were found in the scientific literature. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd6b34d7-d1a8-47d9-8083-20257b02aad3/documents/IUC5-599c7866-8728-4632-8189-eec84f8fbf64_8fd0278f-0de0-408d-a0de-ae8dc2104b8e.html,,,,,, "Ylang-ylang, ext.",83863-30-3, Repeated dose toxicity (OECD TG 422): NOAEL = 718 mg/kg bw/day in males and 953 mg/kg bw/day in females. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4ecff5e-c283-4fc8-9e54-eb07afed8925/documents/63bdf5a4-a875-41f9-81a9-6174a1b9ff3f_a3549472-624d-465e-bf66-13b9330f9ab8.html,,,,,, "Ylang-ylang, ext.",83863-30-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4ecff5e-c283-4fc8-9e54-eb07afed8925/documents/63bdf5a4-a875-41f9-81a9-6174a1b9ff3f_a3549472-624d-465e-bf66-13b9330f9ab8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,718 mg/kg bw/day,,rat "Ylang-ylang, ext.",83863-30-3, Acute oral toxicity (OECD TG 401) LD50 >5000 mg/kg bw Acuter dermal toxicity (OECD TG 402) LD50 >5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4ecff5e-c283-4fc8-9e54-eb07afed8925/documents/93fd90cf-5cae-42a8-9e31-764ecb775368_a3549472-624d-465e-bf66-13b9330f9ab8.html,,,,,, Hexanoic acid,142-62-1," Key studies on oral repeated dose toxicity are available for the following category members: Subchronic (84 days, rat): NOAEL oral ≥ 12500 mg/kg bw/day; CAS# 112-80-1, C18:1 (Calandra, 1969) Subacute (OECD 422, rat): NOAEL oral ≥ 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao et al., 2002) Subacute (OECD 407, rat): NOAEL oral ≥ 1000 mg/kg bw/day; CAS# 112-05-0, C9 (van Otterdijk, 2002) Subacute (OECD 407, rat): NOAEL oral ≥ 1000 mg/kg bw/day; CAS# 70321-72-1, C8-18 and C18-unsatd, distn. residues (Potokar, 1983) In conclusion, no human hazard for systemic toxicity after repeated oral exposure was identified for the members of the fatty acids category. No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b14a4b9c-cd76-4eaa-854d-6632f8d1b431/documents/4b06db2d-7187-4d37-a624-d49e139c7f7f_a4cc6377-a198-4cf8-81a2-9b6911089096.html,,,,,, Hexanoic acid,142-62-1," No acute toxicity studies are required according to Regulation (EC) No. 1907/2006 Annex VII and VIII, Section 8.5, Column 2 as hexanoic acid is classified as corrosive to the skin. However, taken all available data together in a weight of evidence approach, hexanoic acid is considered not acutely toxic via the oral and dermal route: Oral, rat: estimated LD50: 6440 mg/kg bw (Smyth et al., 1954) Oral, screening, rat: estimated LD50: 3000 mg/kg bw (Smyth and Carpenter, 1944) Dermal, rabbit, 24h: LD50: 586 mg/kg bw (Smyth et al., 1954) Dermal, screening, guinea pigs, 4d: LD50: 4650 mg/kg bw (Smyth and Carpenter, 1944) Dermal (OECD 402, limit test), rat: LD50 >2000 mg/kg bw; CAS# 112-05-0, C9 (van Otterdijk, 2001) Dermal (OECD 402, limit test), rat: LD50 >2000 mg/kg bw; CAS# 111-20-6, C9d (Yu, 1999) Dermal (OECD 402, limit test), rat: LD50 >2000 mg/kg bw; CAS# 334-48-5, C10 (TalviOja, 2006) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b14a4b9c-cd76-4eaa-854d-6632f8d1b431/documents/IUC5-021d05e4-51fb-4094-a1d2-592f446cc09d_a4cc6377-a198-4cf8-81a2-9b6911089096.html,,,,,, Hexanoic acid,142-62-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b14a4b9c-cd76-4eaa-854d-6632f8d1b431/documents/IUC5-021d05e4-51fb-4094-a1d2-592f446cc09d_a4cc6377-a198-4cf8-81a2-9b6911089096.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Hexanoic acid,142-62-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b14a4b9c-cd76-4eaa-854d-6632f8d1b431/documents/IUC5-021d05e4-51fb-4094-a1d2-592f446cc09d_a4cc6377-a198-4cf8-81a2-9b6911089096.html,,dermal,LD50,"> 20,000 mg/kg bw",no adverse effect observed, ε-caprolactam,105-60-2," Based on the available data from a study compareable to OECD Guideline 408 the NOEAL for general systemic effects in mal rats was 29 mg/kg bw/d and 342 mg/kg bw/d in female rats. The NOAEC in rats for systemic inhalation effects was 0.245 mg/l and for local effects 0.066mg/l based on the results of a study performed described by TSCA, EPA September 195 and May 1989. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1018f5b-1299-42b2-afc1-afd8757b78cd/documents/IUC5-453cac74-7a9d-47c6-aae1-acfbf9d0e761_230f8f84-b001-4c53-aba7-a77b02796d10.html,,,,,, ε-caprolactam,105-60-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1018f5b-1299-42b2-afc1-afd8757b78cd/documents/IUC5-453cac74-7a9d-47c6-aae1-acfbf9d0e761_230f8f84-b001-4c53-aba7-a77b02796d10.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,29 mg/kg bw/day,,rat ε-caprolactam,105-60-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1018f5b-1299-42b2-afc1-afd8757b78cd/documents/IUC5-453cac74-7a9d-47c6-aae1-acfbf9d0e761_230f8f84-b001-4c53-aba7-a77b02796d10.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,245 mg/m3,, ε-caprolactam,105-60-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1018f5b-1299-42b2-afc1-afd8757b78cd/documents/IUC5-453cac74-7a9d-47c6-aae1-acfbf9d0e761_230f8f84-b001-4c53-aba7-a77b02796d10.html,Repeated dose toxicity – local effects,inhalation,NOAEC,66 mg/m3,adverse effect observed, ε-caprolactam,105-60-2,LD50 Oral (rat) = 1876 mg/kg bw (male) and 1475 mg/kg bw (female)LD50 Dermal = >2000 mg/kg bw (rat) LC50 Inhalation-aerosol (rat) = 8.16 mg/l (male/female) with 1 of 10 dead animals at limit dose of approx 5 mg/l. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1018f5b-1299-42b2-afc1-afd8757b78cd/documents/IUC5-d714cb77-40bb-440b-8cc8-08d0b08ef5c6_230f8f84-b001-4c53-aba7-a77b02796d10.html,,,,,, ε-caprolactam,105-60-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1018f5b-1299-42b2-afc1-afd8757b78cd/documents/IUC5-d714cb77-40bb-440b-8cc8-08d0b08ef5c6_230f8f84-b001-4c53-aba7-a77b02796d10.html,,oral,LD50,"1,475 mg/kg bw",adverse effect observed, ε-caprolactam,105-60-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1018f5b-1299-42b2-afc1-afd8757b78cd/documents/IUC5-d714cb77-40bb-440b-8cc8-08d0b08ef5c6_230f8f84-b001-4c53-aba7-a77b02796d10.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, ε-caprolactam,105-60-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1018f5b-1299-42b2-afc1-afd8757b78cd/documents/IUC5-d714cb77-40bb-440b-8cc8-08d0b08ef5c6_230f8f84-b001-4c53-aba7-a77b02796d10.html,,inhalation,LC50,"816,000 mg/m3",adverse effect observed, "Octan-1-ol, ethoxylated",27252-75-1,"An acute toxicity study is not required for octan-1-ol, ethoxylated (CAS No. 27252-75-1, EC No. 500-058-1) according to the REACH Regulation (EC) No. 1907/2006, Annex VII, Section 8.5, Column 2, because the substance is classified as corrosive to the skin. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47e4a7f0-f658-4f1d-a127-0eb972d63507/documents/9791328e-b7c0-4cec-bbec-3a4dcf69974d_2a3851cb-eef1-41d5-bf46-51513b91c167.html,,,,,, Octanoic acid,124-07-2," Key studies on oral repeated dose toxicity are available for the following category members: Subchronic (84 days, rat): NOAEL oral ≥ 12500 mg/kg bw/day; CAS# 112-80-1, C18:1 Subacute (OECD 422, rat): NOAEL oral ≥ 1000 mg/kg bw/d; CAS# 112-85-6, C22 Subacute (OECD 407, rat): NOAEL oral ≥ 1000 mg/kg bw/day; CAS# 112-05-0, C9 Subacute (OECD 407, rat): NOAEL oral ≥ 1000 mg/kg bw/day; CAS# 70321-72-1, C8-18 and C18-unsatd, distn. residues In conclusion, no human hazard for systemic toxicity after repeated oral exposure was identified for the members of the fatty acids category. No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1753482f-9d72-4461-9f20-370de537aeb3/documents/IUC5-396342cd-2399-4e89-b25f-7045b6dbf2a1_13950830-341d-4d73-a994-95a3b435253e.html,,,,,, Octanoic acid,124-07-2," Oral (OECD 401, limit test), rat: LD50 >2000 mg/kg bw No testing via the inhalation and dermal route was performed due to the corrosive properties of octanoic acid. However, hazard assessment for acute dermal toxicity is conducted by means of read-across based on a category approach. Reliable studies on acute dermal toxicity are available for the following fatty acids category members: Dermal (OECD 402, limit test), rat: LD50 >2000 mg/kg bw; CAS# 112-05-0, C9, CAS# 123-99-9, C9d; CAS# 111-20-6, C10d; CAS# 334-48-5, C10 Taken together members of the fatty acids category are not acutely toxic via the dermal route. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1753482f-9d72-4461-9f20-370de537aeb3/documents/0ed6a461-e848-469b-a91b-40d0602d283a_13950830-341d-4d73-a994-95a3b435253e.html,,,,,, N-(1-oxooctyl)glycine,14246-53-8,"The test item was administered daily by oral gavage to male and female Sprague-Dawley rats, for 2 weeks before mating, during mating, gestation and until day 5 post-partum, at dose-levels of 25, 75 or 200 mg/kg/day. Loud breathing was observed at all dose-levels but no microscopic abnormalities were found in the respiratory organs of the 200 mg/kg/day animals therefore it was considered that this clinical observation did not induce long-term effects. Males treated at 200 mg/kg/day gained minimally less weight during the first 2 weeks of treatment but some of this was recuped during the second 2 weeks and was therefore considered not to represent an effect of treatment. No histopathological lesions considered to be reflective of systemic toxicity were observed. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/593dee3a-f378-4c07-b27a-07c397eab676/documents/5ceef3da-2b04-4ce1-9e9b-e30442e6dd2b_70cafc73-8860-4588-be4b-2da3c1024f9f.html,,,,,, N-(1-oxooctyl)glycine,14246-53-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/593dee3a-f378-4c07-b27a-07c397eab676/documents/5ceef3da-2b04-4ce1-9e9b-e30442e6dd2b_70cafc73-8860-4588-be4b-2da3c1024f9f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,, N-(1-oxooctyl)glycine,14246-53-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/593dee3a-f378-4c07-b27a-07c397eab676/documents/a4b5f8dc-c478-4bd0-b84e-b67cebdba121_70cafc73-8860-4588-be4b-2da3c1024f9f.html,,oral,LD50,"> 1,000 mg/kg bw",no adverse effect observed, N-(1-oxooctyl)glycine,14246-53-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/593dee3a-f378-4c07-b27a-07c397eab676/documents/a4b5f8dc-c478-4bd0-b84e-b67cebdba121_70cafc73-8860-4588-be4b-2da3c1024f9f.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Octan-1-ol,111-87-5," There are no reliable repeated dose toxicity data on octan-1-ol (CAS 111-87-5). A reliable 13-week dietary study in rats using hexan-1-ol reported a NOAEL of 1127 mg/kg bw/day (Scientific Associates Inc., 1966) is read-across. The results of this key study are supported by a reliable three-week feeding study in rats using hexan-1-ol which reported a NOAEL of approximately 1000 mg/kg bw/day (Moody, 1978). In addition a 90-day repeated dose dermal toxicity study (Wil Research, 1995) in rats where a multi-constituent solution containing circa 50% decan-1-ol and circa 45% octan-1-ol (semi-occluded conditions) reported no systemic effects at the highest dose tested. The study did give rise to marked dermal irritative effect. It is however important to take into account the different test protocol that was used, that is a subchronic repeated dose dermal toxicity study (6 hours/day for 5 days/week during 90 days, in rats) compared to an OECD Test Guideline acute dermal irritation study (4 hours in rabbits). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2573eec9-8668-43d2-9c58-3ad8d3f20133/documents/11988678-5a4f-47e0-ae1c-89fe386d5337_ac9c6997-b850-41e2-8278-52fecac3b228.html,,,,,, Octan-1-ol,111-87-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2573eec9-8668-43d2-9c58-3ad8d3f20133/documents/11988678-5a4f-47e0-ae1c-89fe386d5337_ac9c6997-b850-41e2-8278-52fecac3b228.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,127 mg/kg bw/day",,rat Octan-1-ol,111-87-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2573eec9-8668-43d2-9c58-3ad8d3f20133/documents/11988678-5a4f-47e0-ae1c-89fe386d5337_ac9c6997-b850-41e2-8278-52fecac3b228.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat Octan-1-ol,111-87-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2573eec9-8668-43d2-9c58-3ad8d3f20133/documents/11988678-5a4f-47e0-ae1c-89fe386d5337_ac9c6997-b850-41e2-8278-52fecac3b228.html,Repeated dose toxicity – local effects,dermal,NOAEL,2.8 mg/cm2,adverse effect observed,rat Octan-1-ol,111-87-5," In the key acute oral toxicity study for octan-1-ol, conducted according to an appropriate OECD Test Guideline 401 but full details were not available, and in compliance with GLP, an LD50 value of >5000 mg/kg bw was reported when applied as an aqueous solution (Henkel, 1981; rel 2). In the key acute dermal toxicity study for octan-1-ol, which was well-documented and meets generally accepted scientific principles, although conducted prior to GLP, an LD50 value of 2000-4000 mg/kg bw was reported (Scientific Associates 1976; rel 2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2573eec9-8668-43d2-9c58-3ad8d3f20133/documents/1961e1d7-46dc-46bd-9217-499b61ddc01a_ac9c6997-b850-41e2-8278-52fecac3b228.html,,,,,, Octan-1-ol,111-87-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2573eec9-8668-43d2-9c58-3ad8d3f20133/documents/1961e1d7-46dc-46bd-9217-499b61ddc01a_ac9c6997-b850-41e2-8278-52fecac3b228.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Octan-1-ol,111-87-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2573eec9-8668-43d2-9c58-3ad8d3f20133/documents/1961e1d7-46dc-46bd-9217-499b61ddc01a_ac9c6997-b850-41e2-8278-52fecac3b228.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Octyl octanoate,2306-88-9,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45d14140-b4cd-4dea-bcab-4c9e321fef4b/documents/IUC5-2be39757-41f7-4a49-b03d-300254e7bacb_7b5101ee-15f9-44bb-9f1d-0835615b178d.html,,,,,, Octyl octanoate,2306-88-9,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45d14140-b4cd-4dea-bcab-4c9e321fef4b/documents/IUC5-b7765b29-fc70-4101-8017-28197aa32203_7b5101ee-15f9-44bb-9f1d-0835615b178d.html,,,,,, "Octane-1,2-diol",1117-86-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b1cdd14-205b-45d4-9fb2-dcee444a703b/documents/IUC5-cac879b4-7f84-40ca-8b28-c1ff58669973_d5821577-a9d2-49f5-817e-f1ad7e70332d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Octane-1,2-diol",1117-86-8," Oral rat (standard acute method):                                                         LD50 > 2000 mg/kg bw  (no mortality at 2000 mg/kg bw). Acute dermal rat:                                                                                      Waiving, as this study was considered to be scientifically unjustified.       Acute inhalation rat - read-across from pentane-1,2-diol:              LC50 > 7015 mg/m^3 (no mortality at 7015 mg/m^3). In addition octane-1,2-diol has quite a low vapour pressure (0.15 Pa at 20 °C, 0.28 Pa at 25°C) limiting the risk of human exposure to its vapour. Conclusion:              No requirement of classification for acute oral, dermal or inhalation toxicity [DIRECTIVE 67/548/EEC & Reg. (EC) 1272/2008]. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b1cdd14-205b-45d4-9fb2-dcee444a703b/documents/IUC5-5e678b9a-874a-4d58-bcb1-88e23242d3c0_d5821577-a9d2-49f5-817e-f1ad7e70332d.html,,,,,, Octyl laurate,5303-24-2," Oral (read across): OECD 407, rat, NOAEL = 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/355ea256-94a8-4d4d-8641-342edcb87de8/documents/df90e9fc-0420-4afe-9d21-088ce7d48a1e_571f34d6-3469-4053-b5a7-9a4da6759f99.html,,,,,, Octyl laurate,5303-24-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/355ea256-94a8-4d4d-8641-342edcb87de8/documents/df90e9fc-0420-4afe-9d21-088ce7d48a1e_571f34d6-3469-4053-b5a7-9a4da6759f99.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Octyl laurate,5303-24-2," Oral (OECD 401, rat, read across): LD50 > 2000 mg/kg bw Dermal (OECD 404, rat, read across): LD50 > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/355ea256-94a8-4d4d-8641-342edcb87de8/documents/b11d4582-33e5-45d9-b871-67e5c9ce1142_571f34d6-3469-4053-b5a7-9a4da6759f99.html,,,,,, "1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane",17955-88-3,"In the key 90-day oral repeated dose toxicity study with 1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane (CAS 17955-88-3, EC 241-881-3), conducted according to OECD Test Guideline 408 and GLP, Han Wistar rats were administered 0, 100, 300, or 1000 mg/kg bw/day of the test item via oral gavage, with dried and deacidified corn oil as the vehicle and negative control and a 28-day recovery period included. There were no treatment-related effects observed during the study, consequently, the NOAEL was identified as at least 1000 mg/kg bw/day (Charles River Laboratories, 2024, reliability 1). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0aacdb5-f228-4bea-b2c7-567c790d7623/documents/11d117d9-0089-49c2-b6b2-fb02853ef0e1_62f7ccc3-ba96-4a8e-bbc5-7a85f85d414c.html,,,,,, "1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane",17955-88-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0aacdb5-f228-4bea-b2c7-567c790d7623/documents/11d117d9-0089-49c2-b6b2-fb02853ef0e1_62f7ccc3-ba96-4a8e-bbc5-7a85f85d414c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat "1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane",17955-88-3,"In the key acute oral toxicity study, conducted according to OECD TG 423, and in compliance with GLP, the reported LD50 value for 1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane (CAS: 17955-88-3, EC: 241-881-3) was > 2000 mg/kg bw in rats (Eurofins, 2016a, reliability 1). In the key acute dermal toxicity study, conducted according to OECD TG 402, and in compliance with GLP, the reported LD50 value for 1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane was > 2000 mg/kg bw  in rats (Eurofins, 2016b, reliability 1). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0aacdb5-f228-4bea-b2c7-567c790d7623/documents/b4a920b1-4706-4677-8372-7d8b28af275f_62f7ccc3-ba96-4a8e-bbc5-7a85f85d414c.html,,,,,, "1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane",17955-88-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0aacdb5-f228-4bea-b2c7-567c790d7623/documents/b4a920b1-4706-4677-8372-7d8b28af275f_62f7ccc3-ba96-4a8e-bbc5-7a85f85d414c.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1,1,1,3,5,5,5-heptamethyl-3-octyltrisiloxane",17955-88-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0aacdb5-f228-4bea-b2c7-567c790d7623/documents/b4a920b1-4706-4677-8372-7d8b28af275f_62f7ccc3-ba96-4a8e-bbc5-7a85f85d414c.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, N-(n-octyl)-2-pyrrolidinone,2687-94-7,"Several GLP guideline studies were performed: - EPA OPP 82-1 / 90 d study in rat (diet) with a NOEL of 600 ppm (33-65 mg/kg for males, 43-69 mg/kg for females).- EPA OPP 82-1 / 90 d study in dogs (capsule) with a NOAEL of 30 mg/kg for males and females. - OECD415 study / extended 1 generation study with a systemic NOAEL of 1000 mg/kg bw/d for males and 100 mg/kg bw/d for females (see IUCLID section 7.8.1). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d73e8d87-ded5-4109-ac13-bb64ff9d3924/documents/IUC5-e90d74ed-92ff-4112-b1cc-4246ceb98361_7e11f4a9-fae4-4751-9af1-8db7bee89380.html,,,,,, N-(n-octyl)-2-pyrrolidinone,2687-94-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d73e8d87-ded5-4109-ac13-bb64ff9d3924/documents/IUC5-e90d74ed-92ff-4112-b1cc-4246ceb98361_7e11f4a9-fae4-4751-9af1-8db7bee89380.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat N-(n-octyl)-2-pyrrolidinone,2687-94-7,"The acute oral toxicity and the acute dermal toxicity of the test substance were investigated in Wistar rats, both studies were performed according to the respective OECD guidelines. - oral: LD50 (rat) > 2200 mg/kg bw- dermal: LD50 (rat) > 4000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d73e8d87-ded5-4109-ac13-bb64ff9d3924/documents/IUC5-0055237a-347d-4100-83d4-d027a06addcf_7e11f4a9-fae4-4751-9af1-8db7bee89380.html,,,,,, N-(n-octyl)-2-pyrrolidinone,2687-94-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d73e8d87-ded5-4109-ac13-bb64ff9d3924/documents/IUC5-0055237a-347d-4100-83d4-d027a06addcf_7e11f4a9-fae4-4751-9af1-8db7bee89380.html,,oral,discriminating dose,"2,200 mg/kg bw",no adverse effect observed, N-(n-octyl)-2-pyrrolidinone,2687-94-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d73e8d87-ded5-4109-ac13-bb64ff9d3924/documents/IUC5-0055237a-347d-4100-83d4-d027a06addcf_7e11f4a9-fae4-4751-9af1-8db7bee89380.html,,dermal,discriminating dose,"4,000 mg/kg bw",no adverse effect observed, "D-Glucopyranose, oligomers, decyl octyl glycosides",68515-73-1,An oral subchronic repeated dose toxicity study revealed a NOAEL of 1000 mg/kg/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c092f41-44d9-4db5-8f52-c8463faeae97/documents/IUC5-32274caf-7b49-4507-a11d-e8ceda72f5af_3282da4b-d93d-4938-8ff5-d0a44572867b.html,,,,,, "D-Glucopyranose, oligomers, decyl octyl glycosides",68515-73-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c092f41-44d9-4db5-8f52-c8463faeae97/documents/IUC5-32274caf-7b49-4507-a11d-e8ceda72f5af_3282da4b-d93d-4938-8ff5-d0a44572867b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, "D-Glucopyranose, oligomers, decyl octyl glycosides",68515-73-1,"Many high quality studies investigating the acute toxicity of APG have shown that in terms of acute toxicity the use of these compounds are of low concern. They are of low oral, dermal and inhalation toxicity. From a structural activity point of view, the length of the alkyl chain did not exert any meaningful influence on acute toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c092f41-44d9-4db5-8f52-c8463faeae97/documents/IUC5-ec345e2c-f1d2-4449-b555-c3f2eff31ea3_3282da4b-d93d-4938-8ff5-d0a44572867b.html,,,,,, "D-Glucopyranose, oligomers, decyl octyl glycosides",68515-73-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c092f41-44d9-4db5-8f52-c8463faeae97/documents/IUC5-ec345e2c-f1d2-4449-b555-c3f2eff31ea3_3282da4b-d93d-4938-8ff5-d0a44572867b.html,,oral,LD50,"2,000 mg/kg bw",, "D-Glucopyranose, oligomers, decyl octyl glycosides",68515-73-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c092f41-44d9-4db5-8f52-c8463faeae97/documents/IUC5-ec345e2c-f1d2-4449-b555-c3f2eff31ea3_3282da4b-d93d-4938-8ff5-d0a44572867b.html,,dermal,LD50,"2,000 mg/kg bw",, "Capsicum annuum, ext.",84625-29-6," Key study: Test method similar to OECD TG 408. In a 13-week subchronic study, paprika color showed little or no significant toxicity even with 5% supplementation in the diet. Thus, the NOAEL was concluded to be 5% in the diet (0.67 g/rat/day or 2948.4 mg/kg bw/day for male rats and 0.43 g/rat/day or 3197.4 mg/kg bw/day for female rats). Key study: Test method similar to OECD TG 452. In a 52-week chronic study, the NOEL was estimated to be 2.5% in the diet (1253 mg/kg bw/day) and the NOAEL was determined to be 5% in the diet (2388 mg/kg bw/day) for male rats, and for females, the NOEL was concluded to be 5% in the diet (2826 mg/kg bw/day). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2437f48-a060-4b63-8358-f927aeba17c5/documents/9f71fbe0-a984-4628-b0c7-f674dbbf9740_11efbe0e-49ce-4468-bd06-090524096894.html,,,,,, "Capsicum annuum, ext.",84625-29-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2437f48-a060-4b63-8358-f927aeba17c5/documents/9f71fbe0-a984-4628-b0c7-f674dbbf9740_11efbe0e-49ce-4468-bd06-090524096894.html,Chronic toxicity – systemic effects,oral,NOAEL,"2,388 mg/kg bw/day",,rat "Capsicum annuum, ext.",84625-29-6, Acute oral toxicity: Supporting study. The LD50 of the test item is higher than 11250 mg/kg body weight by oral route in the rat. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2437f48-a060-4b63-8358-f927aeba17c5/documents/7f2f5910-02b5-40c2-9d1f-4e2b422c380d_11efbe0e-49ce-4468-bd06-090524096894.html,,,,,, "Capsicum annuum, ext.",84625-29-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2437f48-a060-4b63-8358-f927aeba17c5/documents/7f2f5910-02b5-40c2-9d1f-4e2b422c380d_11efbe0e-49ce-4468-bd06-090524096894.html,,oral,LD50,"11,250 mg/kg bw",no adverse effect observed, Captan,133-06-2,"1. Subchronic (90-day) study inhalation (nose only), rat ALpk:APfSD (Wistar derived) m/f, USEPA Guideline 82-4; method B.29 of Regulation (EC) No 440/2008, Repeated Dose (90 Days) Toxicity (Inhalation): NOEC: 0.60 mg/L 2. Chronic Toxicity (52 weeks) oral feed, beagle dogs m/f, (USEPA Guideline 83-1 (Chronic Toxicity)), Repeated dose (one dose daily/52 weeks), Toxicity (oral): NOEL: 300 mg/kg bw/day (m/f) 3. Subacute (21-day) study dermal (occlusive), rabbit (New Zealand White) m/f, (USEPA Guideline 83-1. (Repeated Dose (21 Days) Toxicity (Dermal): NOEL: 110 mg/kg bw/day (m/f) systemic effects, NOEL: 12.5 mg/kg bw (m/f) local effects ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/435e269f-a0b7-473d-b8d5-064e98769058/documents/IUC5-91f26520-f3cb-4b81-8b1d-4e2d7d3e12d1_2984d94b-122c-438b-b276-1ff6a72666f3.html,,,,,, Captan,133-06-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/435e269f-a0b7-473d-b8d5-064e98769058/documents/IUC5-91f26520-f3cb-4b81-8b1d-4e2d7d3e12d1_2984d94b-122c-438b-b276-1ff6a72666f3.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,110 mg/kg bw/day,,rabbit Captan,133-06-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/435e269f-a0b7-473d-b8d5-064e98769058/documents/IUC5-91f26520-f3cb-4b81-8b1d-4e2d7d3e12d1_2984d94b-122c-438b-b276-1ff6a72666f3.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,300 mg/m3,,rat Captan,133-06-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/435e269f-a0b7-473d-b8d5-064e98769058/documents/IUC5-91f26520-f3cb-4b81-8b1d-4e2d7d3e12d1_2984d94b-122c-438b-b276-1ff6a72666f3.html,Chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,dog Captan,133-06-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/435e269f-a0b7-473d-b8d5-064e98769058/documents/IUC5-91f26520-f3cb-4b81-8b1d-4e2d7d3e12d1_2984d94b-122c-438b-b276-1ff6a72666f3.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.48 mg/cm2,adverse effect observed,rabbit Captan,133-06-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/435e269f-a0b7-473d-b8d5-064e98769058/documents/IUC5-91f26520-f3cb-4b81-8b1d-4e2d7d3e12d1_2984d94b-122c-438b-b276-1ff6a72666f3.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.6 mg/m3,adverse effect observed,rat Captan,133-06-2,"1. Acute (one single dose) study oral (gavage), rat m/f, (OECD 401 (1987) = EEC B.1 (1992): LD50 > 2000 mg/kg bodyweight. 2. Acute (single 4 hour exposure) study inhalation, rat m/f, EEC B.2 (1984), OECD 403 (1984): LC50 = 0.67 mg/l (female, 95% confidence limits 0.36 - 1.22).In accordance with the provisions of regulation 1272/2008, Annex I, 3. is classified as acute toxic cat. 3 . 3. Acute (one single application) study dermal, rabbit m/f, EPA FIFRA, Subdivision F, §81-2 (1981) = EEC B.3 (1992): LD50 > 2000 mg/kg ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/435e269f-a0b7-473d-b8d5-064e98769058/documents/IUC5-af4db132-54d0-4359-98d1-80fa8573059d_2984d94b-122c-438b-b276-1ff6a72666f3.html,,,,,, Captan,133-06-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/435e269f-a0b7-473d-b8d5-064e98769058/documents/IUC5-af4db132-54d0-4359-98d1-80fa8573059d_2984d94b-122c-438b-b276-1ff6a72666f3.html,,inhalation,LC50,670 mg/m3,adverse effect observed, "2-Propenoic acid, homopolymer",9003-01-4," Following repeated oral administration of the analogue acrylic acid in drinking water to Wistar rats at the dose levels of 0, 120, 800, 2000 or 5000 ppm (equivalent to 0, 6, 40, 100 or 200 mg/kg and 0, 10, 66, 150 or 375 mg/kg, for males and females respectively) for 12 months, the dose of 800 ppm in males (equivalent to 40 mg/kg) was identified as a NOAEL based on decreased water intake and body weight at higher dose levels. No target organs were identified. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acc84d3e-3d80-49b7-8b1a-fec78ac6ef27/documents/2e403ea1-7ff9-4112-a000-56478e828564_93174655-6f48-4973-b363-a35d71b6ce6d.html,,,,,, "2-Propenoic acid, homopolymer",9003-01-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acc84d3e-3d80-49b7-8b1a-fec78ac6ef27/documents/2e403ea1-7ff9-4112-a000-56478e828564_93174655-6f48-4973-b363-a35d71b6ce6d.html,Chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat "2-Propenoic acid, homopolymer",9003-01-4,"Information was obtained from read-across from supporting substance (acrylic acid) which is of moderate toxicity after a single ingestion and after short-term inhalation exposure. Acrylic acid is not toxic after short-term skin contact, when tested in non-corrosive concentrations.- Oral: LD50 = 1500 mg/kg or 146-1405 mg/kg bw (rat) depending on the concentration tested- Dermal: LD50 > 2000 mg/kg bw (rabbit, occlusive)- Inhalation: LC50 > 5.1 mg/L (rat, vapour saturated atmosphere) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acc84d3e-3d80-49b7-8b1a-fec78ac6ef27/documents/5248a04c-f6a9-4022-8e44-4efe63364f1b_93174655-6f48-4973-b363-a35d71b6ce6d.html,,,,,, "2-Propenoic acid, homopolymer",9003-01-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acc84d3e-3d80-49b7-8b1a-fec78ac6ef27/documents/5248a04c-f6a9-4022-8e44-4efe63364f1b_93174655-6f48-4973-b363-a35d71b6ce6d.html,,oral,LD50,"1,500 mg/kg bw",adverse effect observed, Carnosine,305-84-0," Acute Toxicity oral, mouse: LD50> 14930 mg/kg bw   Acute toxicity, intravenous administration, rat: LD50 > 2000 mg/kg bw, no adverse effect observed after administration of doses up to 2000 mg/kg bw (Please refer to study entry: acute toxicity: other routes (WoE_AT_rat_RL2)) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c558a8b-b74b-4283-873a-e4bd3772b171/documents/b250001f-338b-47bc-8067-6ce022114e47_f5cbad47-0f7e-4060-a2a4-5355f1e0a81e.html,,,,,, Carvacrol,499-75-2," There is no repeated dose toxicity data available for Carvacrol. A read across approach was conducted with a Combined Repeated Dose and Reproduction/Developmental Toxicity Screening Test from Thymol (CAS No. 89-83-8). Read-across from Thymol - subacute NOEL (male/female, rat): 8 mg/kg bw/day (OECD 422/GLP) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01acdec4-9484-4f72-9395-fa207ba29ab7/documents/4500b980-bfaa-4c79-a717-a56d57e5ec4c_0b326836-6a9e-4745-840d-ba6e2500405e.html,,,,,, Carvacrol,499-75-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01acdec4-9484-4f72-9395-fa207ba29ab7/documents/4500b980-bfaa-4c79-a717-a56d57e5ec4c_0b326836-6a9e-4745-840d-ba6e2500405e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,8 mg/kg bw/day,,rat Carvacrol,499-75-2, Acute Oral Toxicity: LD50 (male/female) is 810mg/kg bw with 95% confidence limits of 710-920 mg/kg bw. (Similar to OECD 401) Acute Inhalational Toxicity: This endpoint is waived as the substance is classified as Skin corrosive Category 1B/C. Acute Dermal Toxicity: This endpoint is waived as the substance is classified as Skin corrosive Category 1B/C. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01acdec4-9484-4f72-9395-fa207ba29ab7/documents/0100dd7a-431e-48a8-98a7-85d39dccaf52_0b326836-6a9e-4745-840d-ba6e2500405e.html,,,,,, Carvacrol,499-75-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01acdec4-9484-4f72-9395-fa207ba29ab7/documents/0100dd7a-431e-48a8-98a7-85d39dccaf52_0b326836-6a9e-4745-840d-ba6e2500405e.html,,oral,LD50,810 mg/kg bw,adverse effect observed, "L-p-mentha-1(6),8-dien-2-one",6485-40-1, Read Across from d-carvone - Subchronic NOAEL (mouse): 375 mg/kg bw/day (equivalent or similar to OECD 408) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d4309bf-cc3f-4d50-91f0-31be4efc5bd9/documents/IUC5-301f02c0-a77e-44be-bb6b-13d67edce708_63125fd4-8f64-4428-bc32-c668bbff72dc.html,,,,,, "L-p-mentha-1(6),8-dien-2-one",6485-40-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d4309bf-cc3f-4d50-91f0-31be4efc5bd9/documents/IUC5-301f02c0-a77e-44be-bb6b-13d67edce708_63125fd4-8f64-4428-bc32-c668bbff72dc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,375 mg/kg bw/day,,mouse "L-p-mentha-1(6),8-dien-2-one",6485-40-1, LD50 Oral (male/female): 5400mg/kg bw  (OECD 401;GLP)   LD50 Dermal: >2000mg/kg bw  (OECD 402; GLP) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d4309bf-cc3f-4d50-91f0-31be4efc5bd9/documents/IUC5-31e05cc3-7c92-4f82-a82c-e77dc7080ca2_63125fd4-8f64-4428-bc32-c668bbff72dc.html,,,,,, "L-p-mentha-1(6),8-dien-2-one",6485-40-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d4309bf-cc3f-4d50-91f0-31be4efc5bd9/documents/IUC5-31e05cc3-7c92-4f82-a82c-e77dc7080ca2_63125fd4-8f64-4428-bc32-c668bbff72dc.html,,oral,LD50,"5,400 mg/kg bw",no adverse effect observed, "L-p-mentha-1(6),8-dien-2-one",6485-40-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d4309bf-cc3f-4d50-91f0-31be4efc5bd9/documents/IUC5-31e05cc3-7c92-4f82-a82c-e77dc7080ca2_63125fd4-8f64-4428-bc32-c668bbff72dc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, (S)-2-methyl-5-(1-methylvinyl)cyclohex-2-en-1-one,2244-16-8," Repeated dose toxicity: Oral Chronic toxicity study was performed for d- carvone using B6C3F1 mice. The test chemical was mixed with corn oil and dosed by the gavage route of exposure to male and female at dose levels of 0, 375 or 750 mg/kg. During the study period, the animals were observed for clinical signs, body weight changes, organ weight changes and histopathalogy.The survival of both 375 mg/Kg (after week 101) and 750 mg/Kg (after week 92) groups of female mice was significantly greater than that of the vehicle controIs. No significant differences were observed between any groups of male mice. No compound-related clinical signs were observed. Mean body weights of dosed and vehicle control male mice were similar throughout most of the studies; mean body weights of dosed female mice were within 7% of those of vehicle controls throughout most of the studies. No increase in neoplastic lesions was observed in dosed mice. No increases in tumor incidences were observed in mice administered d-carvone. In the current study, only nine primary neoplasms were seen in female vehicle control mice, each in a different animal. This low number may be related to the early deaths of female vehicle control mice. However, the incidences of male mice with primary neoplasms (vehicle control, 27/50; low dose, 15/50; high dose, 16/50) and the total numbers of primary neoplasms (vehicle control, 38; low dose, 18; high dose, 20) were significantly lower in dosed groups than in vehicle controls. It is not known if the low tumor yields are related to d-carvone administration. The only lesions considered possibly related to d-carvone in the 2-year studies in mice were atrophy of the olfactory epithelium and hyperplasia of the underlying Bowman's glands. These mayhave been related to reflux of d-carvone into the nose after the gavage needle was withdrawn, because inflammatory exudate and ""foreign material"" were often found in the nasal passage of dosed animals. Based on these considerations, the No observed Adverse Effect level (NOAEL) for d-carvone using male and female mice in 103 weeks study is considered to be 750 mg/kg/day. Repeated dose toxicity: Inhalation Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for d-carvone. The study assumed the use of male and female Wistar rats in a 90 days toxicity study. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Concentration (NOAEC) for d-carvone is predicted to be 2364.870605469 mg/L.   Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. Repeated dose toxicity: Dermal The acute dermal toxicity value for d-carvone (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not irritating to the skin. Based on these considerations, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b788878-bc6f-48be-b668-8b32ea5b8011/documents/e52b3fb1-deee-494d-9a75-4df59cb8c02d_da883e9e-f145-4f56-aa4f-88ac82bb2e4e.html,,,,,, (S)-2-methyl-5-(1-methylvinyl)cyclohex-2-en-1-one,2244-16-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b788878-bc6f-48be-b668-8b32ea5b8011/documents/e52b3fb1-deee-494d-9a75-4df59cb8c02d_da883e9e-f145-4f56-aa4f-88ac82bb2e4e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"2,364,870 mg/m3",,rat (S)-2-methyl-5-(1-methylvinyl)cyclohex-2-en-1-one,2244-16-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b788878-bc6f-48be-b668-8b32ea5b8011/documents/e52b3fb1-deee-494d-9a75-4df59cb8c02d_da883e9e-f145-4f56-aa4f-88ac82bb2e4e.html,Chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,mouse (S)-2-methyl-5-(1-methylvinyl)cyclohex-2-en-1-one,2244-16-8," Acute Oral Toxicity:  In Acute oral toxicity,LD50 value for target substance d-Carvone (2244-16-8) was considered to be 3710 mg/kg bw and 3560 mg/kg bw in rats. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw.Thus, comparing this value with the criteria of CLP regulation, d-Carvone (2244-16-8) cannot be classified for acute oral toxicity. Acute Inhalation Toxicity:  In Acute inhalation toxicity, LD50 value was predicted based on OECD QSAR toolbox for target substance d-Carvone (2244-16-8) was estimated to be 22.07 mg/L in air ( 22070 mg/m3),and for differentstudies available on the structurally similar read across substance 2-Methyl-5-(1-methylethenyl)-2-cyclohexenone (99-49-0) was considered to be >5.66 mg/l in air and for Spearmint Oil (8008-79-5) was considered to be >5.43 mg/l in air. All these studies concluded that the LC50 value is greater than 5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, d-Carvone (2244-16-8) cannot be classified for acute inhalation toxicity. Acute Dermal Toxicity: In Acute dermal toxicity, LD50 value for target substance d-Carvone (2244-16-8) was considered to be 4000 mg/kg bw; 3840 mg/kg bw and 3840 mg/kg bw in rabbits. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, d-Carvone (2244-16-8) cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b788878-bc6f-48be-b668-8b32ea5b8011/documents/30749de2-4f78-4f29-80b5-f73eaceb7709_da883e9e-f145-4f56-aa4f-88ac82bb2e4e.html,,,,,, (S)-2-methyl-5-(1-methylvinyl)cyclohex-2-en-1-one,2244-16-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b788878-bc6f-48be-b668-8b32ea5b8011/documents/30749de2-4f78-4f29-80b5-f73eaceb7709_da883e9e-f145-4f56-aa4f-88ac82bb2e4e.html,,oral,LD50,"3,710 mg/kg bw",no adverse effect observed, (S)-2-methyl-5-(1-methylvinyl)cyclohex-2-en-1-one,2244-16-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b788878-bc6f-48be-b668-8b32ea5b8011/documents/30749de2-4f78-4f29-80b5-f73eaceb7709_da883e9e-f145-4f56-aa4f-88ac82bb2e4e.html,,dermal,LD50,"4,000 mg/kg bw",no adverse effect observed, (S)-2-methyl-5-(1-methylvinyl)cyclohex-2-en-1-one,2244-16-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b788878-bc6f-48be-b668-8b32ea5b8011/documents/30749de2-4f78-4f29-80b5-f73eaceb7709_da883e9e-f145-4f56-aa4f-88ac82bb2e4e.html,,inhalation,LC50,"22,070 mg/m3",no adverse effect observed, "Castor oil, hydrogenated, ethoxylated",61788-85-0," In a study according to OECD 422, oral administration (by gavage) of the substance to Wistar rats at the doses of 100, 300 and 1000 mg/kg/day for two weeks prior to mating and up to the day before sacrifice inclusive (males) or up to days 13-15 of lactation (females) was well tolerated. No test item related mortality was recorded during the study. There were no signs of evident toxicity related to clinical signs, sensory reactivity, grip strength or motor activity. Regarding body weights and food consumption, lower mean values with respect to Control were recorded in males as well as for food consumption in females. However, given the magnitude observed and the fact that the effect in food consumption was also recorded during pre-test, it needs to be considered as a non-adverse effect. The statistical differences observed in in hematology, coagulation or clinical biochemistry were not considered to be test item related, based on the magnitude and in the absence of a dose relation. These values were within those observed in rats of this strain and age and were there attributed to normal biological variation. There was no indication of an effect of the substance on T4 levels and there was no evidence of a test-item effect in the histopathology performed on F0 adults. There were no changes in the macroscopic examination or organ weights that could be attributable to the substance. Administration of the substance to Wistar rats by oral gavage for 5-8 weeks was not associated with macro/micropathological findings in this study. In the testes, seminiferous tubules were evaluated with respect to their stage in the spermatogenic cycle and the integrity of the various cell types present within the different stages. No cell or stage-specific abnormalities were noted in males treated at 1000 mg/kg. The NOAEL for repeated dose toxicity was considered to be 1000 mg/kg/day for males and females, taking into account the slight decrease in food consumption and body weights. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/402fc1d3-8383-48bd-bf6d-d7f35549d910/documents/2f60b578-fc85-4676-a15d-f2c436804c5c_adacd106-df70-4932-919c-dd0879dac203.html,,,,,, "Castor oil, hydrogenated, ethoxylated",61788-85-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/402fc1d3-8383-48bd-bf6d-d7f35549d910/documents/2f60b578-fc85-4676-a15d-f2c436804c5c_adacd106-df70-4932-919c-dd0879dac203.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Castor oil, hydrogenated, ethoxylated",61788-85-0," In a fixed dose procedure 5 female rats received a single dose of 2000 mg/kg bw by gavage. Rats were observed for 14 days thereafter. No mortality occurred. One female showed hunched posture, ataxia, noisy respiration, increased salivation and lethargy during the first day. The other females showed hunched posture during the first 2 hours after dosing. There were no effects on body weight and no macroscopic findings. Based on these findings the oral LD50 of the substance is > 2000 mg/kg bw. As the substance is of low acute oral toxicity, is not classified as STOT SE and there are no other signs of systemic toxicity, the acute dermal toxicity study has been waived. As the inhalation exposure route is not relevant for this substance no acute study via the inhalation route is included. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/402fc1d3-8383-48bd-bf6d-d7f35549d910/documents/48a66aed-d209-4063-9fa1-b78de06eaca6_adacd106-df70-4932-919c-dd0879dac203.html,,,,,, "Castor oil, hydrogenated, ethoxylated",61788-85-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/402fc1d3-8383-48bd-bf6d-d7f35549d910/documents/48a66aed-d209-4063-9fa1-b78de06eaca6_adacd106-df70-4932-919c-dd0879dac203.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Catalase,9001-05-2," The repeated dose oral toxicity of Catalase has been tested.  The repeated dose inhalation and dermal toxicity were waived based on exposure considerations and the properties of the substance. The repeated dose oral toxicity was a subchronic toxicity test conducted according to OECD guideline 408, and in compliance with GLP. Under the conditions of this study, the NOAEL for the test substance was 1000 mg TP/kg bw/day for male and female rats, based on a lack of test substance-related effects at the highest dose tested. This NOAEL is equivalent to 1289 mg TOS/kg bw/day in males and females. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed60e45f-f2e0-44cf-a8d7-35e18081ca2d/documents/IUC5-327eac56-34f1-4ce5-8429-adeb30f863df_0fc389c0-b98e-4305-98a0-84570698b84d.html,,,,,, Catalase,9001-05-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed60e45f-f2e0-44cf-a8d7-35e18081ca2d/documents/IUC5-327eac56-34f1-4ce5-8429-adeb30f863df_0fc389c0-b98e-4305-98a0-84570698b84d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,289 mg/kg bw/day",,rat Catalase,9001-05-2," An acute oral toxicity study according to OECD Guideline No 425 has been performed and under the conditions of the study, the oral LD50 for Catalase was greater than 5000 mg TP/kg bw (equivalent to 6443 mg TOS/kg bw) for female rats. No other acute toxicity studies were performed with Catalase. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed60e45f-f2e0-44cf-a8d7-35e18081ca2d/documents/686916f4-bbb2-48f2-b3b5-43c7d81d4bf2_0fc389c0-b98e-4305-98a0-84570698b84d.html,,,,,, "Cedrus atlantica, ext.",92201-55-3,Acute oral toxicity: LD50 >5000 mg/kg bw (similar to OECD 401) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/328a103b-28f4-4d47-b370-bcdb8f30b754/documents/IUC5-7027651e-4d4b-4e1d-b252-cabbaa52ebfb_ba96b8d7-305e-4f50-8d12-87f24edb0880.html,,,,,, "Cedrus atlantica, ext.",92201-55-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/328a103b-28f4-4d47-b370-bcdb8f30b754/documents/IUC5-7027651e-4d4b-4e1d-b252-cabbaa52ebfb_ba96b8d7-305e-4f50-8d12-87f24edb0880.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Cedrus deodara, ext.",91771-47-0, Acute oral toxicity using read across from Cedarwood Texas oil distilled: (similar to OECD TG 401): LD50 >5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7af7acd-0442-46fc-a431-3074a1f6b860/documents/a65043a2-97d7-4d4a-bdd4-90f09cb4f12c_5a147ec2-b214-4e72-af83-09df272de75c.html,,,,,, "[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl acetate",77-54-3,"Acute oral toxicity (similar to OECD TG 401): 44,750 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c15942f-48f7-40b1-a13a-2df519b4c937/documents/54680726-516a-470e-9d65-dff799a90ad9_261cdb69-0b30-4934-b55b-53e629425a8a.html,,,,,, "6-tert-butyl-1,1-dimethylindan-4-yl methyl ketone",13171-00-1,Acute oral toxicity: somewhat similar to OECD TG 401: LD50 > 5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95509368-ecd3-4549-8569-3c739ce7e836/documents/6aa12b7d-0ea1-4f09-bdb2-1b4f1c55379f_a224dadb-adeb-46c4-83c4-a0f712225521.html,,,,,, Cellulase,9012-54-8,"The repeated dose oral toxicity of cellulase has been tested, while the repeated dose inhalation and dermal toxicity were waived based on exposure considerations and the properties of the substance. - The dermal study was waived because systemic exposure by the dermal route is unlikely based upon the existing toxicokinetic knowledge of enzymes, which due to their relatively large molecular weight, high water-solubility and low logPow value are not expected to be absorbed through the skin. Therefore, it can be safely assumed that the enzyme do not exert any dermal toxicity. Evidence from animal studies and historical human experience derived from the use of detergent enzymes for decades confirm that exposure to technical enzymes will not result in any toxicologically relevant uptake by dermal route. - The inhalation study was waived because exposure is too low to exert any toxicity. Potential exposure by inhalation to an amount of enzyme, which is toxicologically relevant, is unrealistic due to the stringent work practices and the formulation of enzymes, enforced because of the risk of sensitization by inhalation. - The repeated dose oral toxicity was a subchronic toxicity test conducted according to OECD guideline 608 , and in compliance with GLP. The conclusion was that the No Observed Adverse Effect Level (NOAEL) in rats was the highest dose level tested- 1000 mg/kg bw/day which is equivalent to 1013.3 mg enzyme concentrate dry matter/kg bw/day = 469 mg active enzyme protein/kg bw/day.Based on the repeated dose oral study and weight of evidence, cellulase does not exert any repeated dose oral, dermal or inhalation toxicity to workers or consumers. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Toxicological data has been generated within the enzyme producing industry during the last 40 years. Substantial documentation on the safety of the production strains have been generated, and the enzyme test materials are thoroughly characterized. High quality studies for all relevant endpoints, in vivo studies as well as in vitro studies, show that industrial enzymes from well-known and well-characterized production strains have very similar safety profiles across the catalytic activities. The database can thus be considered of high quality. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acc73b9d-8b1b-4766-8984-99dade8280d4/documents/IUC5-fbb3ba6a-e332-43fc-b790-342d89b06197_147b9dcf-d8be-4b28-a94a-0ef45e6c1963.html,,,,,, Cellulase,9012-54-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acc73b9d-8b1b-4766-8984-99dade8280d4/documents/IUC5-fbb3ba6a-e332-43fc-b790-342d89b06197_147b9dcf-d8be-4b28-a94a-0ef45e6c1963.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Cellulase,9012-54-8,"Acute toxicity via the oral route has been tested. No signs of toxicity were observed in five male and five female rats treated with a single oral dose of 2960 mg enzyme concentrate dry matter/kg bw. The test was conducted according to OECD guidelines and GLP standards. Acute toxicity via inhalation route has been tested. Cellulase causes only minimal evidence of toxicity in rats after 4 hours of inhalation of a concentration of 4.86 mg/L (corresponding to 4.72 mg enzyme concentrate dry matter/L). The LC50 for Cellulase is in excess of 4.72 mg enzyme concentrate dry matter/L. The test was conducted according to OECD guidelines and GLP standards. Acute toxicity via dermal route is waived based on exposure considerations and the known properties of the substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Toxicological data has been generated within the enzyme producing industry during the last 40 years. Substantial documentation on the safety of the production strains have been generated, and the enzyme test materials are thoroughly characterized. High quality studies for all relevant endpoints, in vivo studies as well as in vitro studies, show that industrial enzymes from well-known and well-characterized production strains have very similar safety profiles across the catalytic activities. Read-across can therefore be applied for the majority of toxicological endpoints. The database can thus be considered of high quality. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Toxicological data has been generated within the enzyme producing industry during the last 40 years. Substantial documentation on the safety of the production strains have been generated, and the enzyme test materials are thoroughly characterized. High quality studies for all relevant endpoints, in vivo studies as well as in vitro studies, show that industrial enzymes from well-known and well-characterized production strains have very similar safety profiles across the catalytic activities. Read-across can therefore be applied for the majority of toxicological endpoints. The database can thus be considered of high quality. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acc73b9d-8b1b-4766-8984-99dade8280d4/documents/bdca1dcc-4b80-476f-bc8d-be67e3444ed5_147b9dcf-d8be-4b28-a94a-0ef45e6c1963.html,,,,,, Cellulase,9012-54-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acc73b9d-8b1b-4766-8984-99dade8280d4/documents/bdca1dcc-4b80-476f-bc8d-be67e3444ed5_147b9dcf-d8be-4b28-a94a-0ef45e6c1963.html,,oral,LD50,"2,960 mg/kg bw",no adverse effect observed, Cellulase,9012-54-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acc73b9d-8b1b-4766-8984-99dade8280d4/documents/bdca1dcc-4b80-476f-bc8d-be67e3444ed5_147b9dcf-d8be-4b28-a94a-0ef45e6c1963.html,,inhalation,LC50,"4,720 mg/m3",adverse effect observed, "Hydrocotyle asiatica, ext.",84696-21-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2db17708-40ff-4a58-bf6e-ffd663fefaed/documents/ce028425-923a-4c5b-9250-1125233972be_0d4a56cd-61b6-456e-8730-617070fad32a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hydrocotyle asiatica, ext.",84696-21-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2db17708-40ff-4a58-bf6e-ffd663fefaed/documents/9040e58a-e0ab-4bd5-bdc2-f256dd750372_0d4a56cd-61b6-456e-8730-617070fad32a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocotyle asiatica, ext.",84696-21-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2db17708-40ff-4a58-bf6e-ffd663fefaed/documents/9040e58a-e0ab-4bd5-bdc2-f256dd750372_0d4a56cd-61b6-456e-8730-617070fad32a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Cerium dioxide,1306-38-3," > Oral route: Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422, GLP) performed with nanoCeO2: * NOAEL (parent) = 1000 mg/kg bw/day (no significant effect observed for the systemic toxicity and the reproductive performances) * NOEL (developmental) = 1000 mg/kg bw/day (no significant effect observed on pups) > Inhalation route (1 year) - provisional pending the publication of the carcinogenicity study done by BASF * Systemic effect: NOAEC (male/female rodent) > 3 mg/m3 * Local effect (respiratory tract): NOAEC (male/female rodent) ≥ will be defined later when the carcinogenicity study will be available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9085f25d-4c4e-4f83-b15c-6ba02627af12/documents/18e9305f-bd9e-4952-bd3a-954635319612_00922388-4902-4a4e-9188-525a72878a57.html,,,,,, Cerium dioxide,1306-38-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9085f25d-4c4e-4f83-b15c-6ba02627af12/documents/18e9305f-bd9e-4952-bd3a-954635319612_00922388-4902-4a4e-9188-525a72878a57.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Cerium dioxide,1306-38-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9085f25d-4c4e-4f83-b15c-6ba02627af12/documents/18e9305f-bd9e-4952-bd3a-954635319612_00922388-4902-4a4e-9188-525a72878a57.html,Chronic toxicity – systemic effects,inhalation,NOAEC,3 mg/m3,,rat Cerium dioxide,1306-38-3,"LD50 oral, rat > 5000 mg/kg bwLC50 inhalation, rat > 5.05 mg/L (4 hours)LD50 dermal, rat > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9085f25d-4c4e-4f83-b15c-6ba02627af12/documents/6998fafc-b53a-4962-bf0a-ed89d9713ecf_00922388-4902-4a4e-9188-525a72878a57.html,,,,,, Cerium dioxide,1306-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9085f25d-4c4e-4f83-b15c-6ba02627af12/documents/6998fafc-b53a-4962-bf0a-ed89d9713ecf_00922388-4902-4a4e-9188-525a72878a57.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Cerium dioxide,1306-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9085f25d-4c4e-4f83-b15c-6ba02627af12/documents/6998fafc-b53a-4962-bf0a-ed89d9713ecf_00922388-4902-4a4e-9188-525a72878a57.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Cerium dioxide,1306-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9085f25d-4c4e-4f83-b15c-6ba02627af12/documents/6998fafc-b53a-4962-bf0a-ed89d9713ecf_00922388-4902-4a4e-9188-525a72878a57.html,,inhalation,LC50,5.05 mg/m3,no adverse effect observed, Cetalkonium chloride,122-18-9," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is 1300 mg/kg bw. The study concluded that LD50 is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 1.24E-008 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is 1300 mg/kg bw. The study concluded that LD50 value is between 1000-2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03538a61-3ac0-453c-b516-3fbf60746a1e/documents/fd702126-1a0b-43ba-9222-df8889c4e6b2_50dbeb45-2dea-41b1-90f9-11fdfb9dd9a1.html,,,,,, Cetalkonium chloride,122-18-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03538a61-3ac0-453c-b516-3fbf60746a1e/documents/fd702126-1a0b-43ba-9222-df8889c4e6b2_50dbeb45-2dea-41b1-90f9-11fdfb9dd9a1.html,,oral,LD50,"1,300 mg/kg bw",adverse effect observed, Cetalkonium chloride,122-18-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03538a61-3ac0-453c-b516-3fbf60746a1e/documents/fd702126-1a0b-43ba-9222-df8889c4e6b2_50dbeb45-2dea-41b1-90f9-11fdfb9dd9a1.html,,dermal,LD50,"1,300 mg/kg bw",adverse effect observed, "Quaternary ammonium compounds, di-C16-18-alkyldimethyl, chlorides",92129-33-4,"The potential toxicity of quaternary ammonium compound, di-C16 -18 -alkyldimethyl, chloride following repeated administration was assessed using:- A subacute (28-day) oral toxicity study performed in rats according to OECD guideline 407 in compliance with Good laboratory practices (Hoechst, 1990)- A subchronic (90-day) feeding study performed in Beagle-dogs according to a method similar to OECD guideline 408 (Lindberg, 1971). Based on some limitations of the 90-day feeding study in dogs, the valid 28-day subacute toxicity study in rats is taken for risk characterisation which is in accordance with the existing EU risk assessment on Dioctadecyldimethylammonium chloride. Based on the results of this study, the NOAEL with regard to systemic oral toxicity was established at 100 mg/kg body weight per day. In an earlier study predating official test guidelines and Good Laboratories Practices, rabbits received technical grade Dioctadecyldimethylammonium chloride (75% active in isopropanol/water) via the dermal route of exposure. Twenty applications (5 per week for 4 consecutive weeks) of 2 mL of 0, 0.2 and 2% aqueous test substance solutions (corresponding to about 0, 4 and 40 mg/kg body weight per day) induced mild local dermal effects but no clinical or morphological signs of substance related systemic toxicity. The NOAEL for dermal systemic effects was greater 40 mg/kg body weight per day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b49e928-f003-4535-8cb9-b42d043c4624/documents/IUC5-761735d5-b59d-4c3e-8089-d4485891bcb8_c783f706-4045-4817-bdf4-924a79257ea4.html,,,,,, "Quaternary ammonium compounds, di-C16-18-alkyldimethyl, chlorides",92129-33-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b49e928-f003-4535-8cb9-b42d043c4624/documents/IUC5-761735d5-b59d-4c3e-8089-d4485891bcb8_c783f706-4045-4817-bdf4-924a79257ea4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Quaternary ammonium compounds, di-C16-18-alkyldimethyl, chlorides",92129-33-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b49e928-f003-4535-8cb9-b42d043c4624/documents/IUC5-761735d5-b59d-4c3e-8089-d4485891bcb8_c783f706-4045-4817-bdf4-924a79257ea4.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,40 mg/kg bw/day,,rabbit "Quaternary ammonium compounds, di-C16-18-alkyldimethyl, chlorides",92129-33-4,"The acute oral toxicity of quaternary ammonium compound, di-C16-18-alkyldimethyl, chloride was assessed using:- An acute oral toxicity limit test performed in rats according to OECD 401 guideline. A statement that the report and the study were audited by the Quality Assurance Unit of the testing laboratory was including in the study report (Kynoch, 1984).- A standard acute oral test performed in rats. The study predates GLP requirements and OECD guidelines but the described method is very closed to the OECD guideline 401 (Oser, 1953).The results of the above mentioned studies were supported by a third study for which only the executive summary of the study report was available (Hoechst, 1986a).The substance is of very low acute toxicity following oral exposure: the oral median lethal dose( LD50) is greater than 2000 mg/kg bw . The acute dermal toxicity of quaternary ammonium compound, di-C16-18-alkyldimethyl, chloride was assessed using:- An acute dermal toxicity limit test performed in rats according to OECD 402 guideline in compliance with Good laboratory practices (Clouzeau, 1988).The substance is of low acute toxicity following dermal exposure: The dermal median lethal dose (LD50) is greater than 2000 mg/kg bw.The acute inhalation toxicity of quaternary ammonium compound, di-C16-18-alkyldimethyl, chloride was assessed using:-An acute inhalation toxicity limit test study performed in rats according to a technique from the US Federal Hazardous Substances Regulations specified in the Revised, Federal Register, september 17, 1964 (Young, 1974). The study predates OECD guidelines and GLP requirements . Although, the study had somme limitations, it do not indicate major concerns. The LC50 was found to be in excess of 180 mg/l after one hour exposure whole-body.In summary, it is concluded that the acute systemic toxicity of quaternary ammonium compound, di-C16-18-alkyldimethyl, chloride is very low for all routes of exposure. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b49e928-f003-4535-8cb9-b42d043c4624/documents/IUC5-c961a3d1-f2e4-4e2c-bd4f-8053c95bc882_c783f706-4045-4817-bdf4-924a79257ea4.html,,,,,, "Quaternary ammonium compounds, di-C16-18-alkyldimethyl, chlorides",92129-33-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b49e928-f003-4535-8cb9-b42d043c4624/documents/IUC5-c961a3d1-f2e4-4e2c-bd4f-8053c95bc882_c783f706-4045-4817-bdf4-924a79257ea4.html,,oral,LD50,"2,000 mg/kg bw",, "Quaternary ammonium compounds, di-C16-18-alkyldimethyl, chlorides",92129-33-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b49e928-f003-4535-8cb9-b42d043c4624/documents/IUC5-c961a3d1-f2e4-4e2c-bd4f-8053c95bc882_c783f706-4045-4817-bdf4-924a79257ea4.html,,dermal,LD50,"2,000 mg/kg bw",, "Quaternary ammonium compounds, di-C16-18-alkyldimethyl, chlorides",92129-33-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b49e928-f003-4535-8cb9-b42d043c4624/documents/IUC5-c961a3d1-f2e4-4e2c-bd4f-8053c95bc882_c783f706-4045-4817-bdf4-924a79257ea4.html,,inhalation,LC50,"180,000 mg/m3",, "Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO",68439-49-6," Oral (subacute, rat, m/f, OECD 422): NOAEL (systemic toxicity) ≥ 1000 mg/kg bw/day Oral (subacute, rat, m/f, OECD 422): NOAEL (local toxicity) ≥ 1000 mg/kg bw/day Oral (subchronic, rat, m/f, OECD 408): NOAEL (systemic toxicity) = 300 mg/kg bw/day Oral (subchronic, rat, m/f, OECD 408): NOAEL (local toxicity) = 1000 mg/kg bw/day   Conclusion based on data obtained with alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5) and considering all the available data on repeated dose toxicity in the Alcohol Ethoxylates (AE) category, in a Weight-of-Evidence approach. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49398643-7b6d-4019-98d0-dd55c2183672/documents/IUC5-24f72ff2-0d8b-4218-9628-38c1d1e8b1a3_b54e50a5-c8d5-473c-9c4b-158f09c135e9.html,,,,,, "Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO",68439-49-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49398643-7b6d-4019-98d0-dd55c2183672/documents/IUC5-24f72ff2-0d8b-4218-9628-38c1d1e8b1a3_b54e50a5-c8d5-473c-9c4b-158f09c135e9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO",68439-49-6," Oral (rat, m/f, OECD 401): LD50 > 10000 mg/kg bw Conclusion based on data obtained with alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO (CAS No. 68439-49-6, EC No. 939-518-5) and considering all available data on acute toxicity in the Alcohol Ethoxylates (AE) category in a Weight-of-Evidence approach. Inhalation: No study required as the inhalation route of exposure is considered less relevant than the dermal route for AE substances. Dermal: According to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, no study is required as the AE substances do not meet the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49398643-7b6d-4019-98d0-dd55c2183672/documents/IUC5-9599e1b1-e72d-4e18-9bf4-aaf3a14ec210_b54e50a5-c8d5-473c-9c4b-158f09c135e9.html,,,,,, "Alcohols, C16-18 (even numbered), ethoxylated, < 2.5 EO",68439-49-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49398643-7b6d-4019-98d0-dd55c2183672/documents/IUC5-9599e1b1-e72d-4e18-9bf4-aaf3a14ec210_b54e50a5-c8d5-473c-9c4b-158f09c135e9.html,,oral,LD50,"> 10,000 mg/kg bw",no adverse effect observed, "Alcohols, C16-18, ethoxylated, phosphates",106233-09-4,"Oral, subacute:according to OECD TG 422 in rats: systemic NOAEL=800 mg/kg bw/d (highest dose tested) (NOAEL = 660 mg/kg bw corrected for molecular weight)local NOAEL=200 mg/kg bw/d (highest dose tested) (NOAEL = 166 mg/kg bw corrected for molecular weight) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5010bda2-617f-4812-9f15-ff5fc8d9597d/documents/IUC5-cbaea078-8d54-478d-adbf-0051975fa5c6_fd5f3fc6-98eb-44fc-ab70-00b72423185c.html,,,,,, "Alcohols, C16-18, ethoxylated, phosphates",106233-09-4,"Oral LD50 (OECD guideline 401), rat > 10000 mg/kg bwDermal LD50 (OECD guideline 402), rat > 2000 mg/kg bwAcute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5010bda2-617f-4812-9f15-ff5fc8d9597d/documents/IUC5-e5eae7bc-3a5b-4a42-b4b2-ad0971d334dd_fd5f3fc6-98eb-44fc-ab70-00b72423185c.html,,,,,, "Alcohols, C16-18",67762-27-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Inhalation exposure: There are no reliable Inhalation Repeated studies available for local effects. The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m3/kg for 24 hours exposure. The resulting air concentration needs to be additionally corrected for 24 hlight activity (20 m3), assuming 100 % absorption for both routes. NOAEL rat 750 mg/kg bw/day ÷1.15 m3/kgbw ÷20m3/rat NOAECrat 32.6 mg/m3 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b48d342f-3f0a-46ff-b2e3-0c8e46a595ca/documents/IUC5-903b9b70-ea3f-4b32-9036-efda8c1d7e94_62d182af-5b93-4474-a0ec-be4e2949bca2.html,,,,,, "Alcohols, C16-18",67762-27-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b48d342f-3f0a-46ff-b2e3-0c8e46a595ca/documents/IUC5-903b9b70-ea3f-4b32-9036-efda8c1d7e94_62d182af-5b93-4474-a0ec-be4e2949bca2.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Alcohols, C16-18",67762-27-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b48d342f-3f0a-46ff-b2e3-0c8e46a595ca/documents/IUC5-903b9b70-ea3f-4b32-9036-efda8c1d7e94_62d182af-5b93-4474-a0ec-be4e2949bca2.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,188.79 mg/m3",,rat "Alcohols, C16-18",67762-27-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b48d342f-3f0a-46ff-b2e3-0c8e46a595ca/documents/IUC5-903b9b70-ea3f-4b32-9036-efda8c1d7e94_62d182af-5b93-4474-a0ec-be4e2949bca2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Alcohols, C16-18",67762-27-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b48d342f-3f0a-46ff-b2e3-0c8e46a595ca/documents/IUC5-903b9b70-ea3f-4b32-9036-efda8c1d7e94_62d182af-5b93-4474-a0ec-be4e2949bca2.html,Repeated dose toxicity – local effects,dermal,NOAEL,5.62 mg/cm2,no adverse effect observed,rat "Alcohols, C16-18",67762-27-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b48d342f-3f0a-46ff-b2e3-0c8e46a595ca/documents/IUC5-903b9b70-ea3f-4b32-9036-efda8c1d7e94_62d182af-5b93-4474-a0ec-be4e2949bca2.html,Repeated dose toxicity – local effects,inhalation,NOAEC,32.6 mg/m3,no adverse effect observed,rat "Alcohols, C16-18",67762-27-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b48d342f-3f0a-46ff-b2e3-0c8e46a595ca/documents/IUC5-0a8465f6-c8bc-407a-8d4f-4bd9315b525c_62d182af-5b93-4474-a0ec-be4e2949bca2.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Alcohols, C16-18",67762-27-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b48d342f-3f0a-46ff-b2e3-0c8e46a595ca/documents/IUC5-0a8465f6-c8bc-407a-8d4f-4bd9315b525c_62d182af-5b93-4474-a0ec-be4e2949bca2.html,,dermal,LD50,"10,000 mg/kg bw",no adverse effect observed, "Alcohols, C16-18",67762-27-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b48d342f-3f0a-46ff-b2e3-0c8e46a595ca/documents/IUC5-0a8465f6-c8bc-407a-8d4f-4bd9315b525c_62d182af-5b93-4474-a0ec-be4e2949bca2.html,,inhalation,LC50,"21,000 mg/m3",no adverse effect observed, "Hexanoic acid, 2-ethyl-, C16-18-alkyl esters",90411-68-0,"A 28 -day study (BASF, 1993) with the structural analogue Fatty acids, C8 -10, C12 -18 -alkyl esters is available, where no adverse effects were found revealing a NOAEL of 1000 mg/kg bw (highest dose tested). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/836098d6-f73b-4d90-a2a8-16c058340c7e/documents/IUC5-68d792cf-daef-46d8-b2fc-7001bdf7888b_95af7cee-7cb5-4918-9c06-ce8e53719c9b.html,,,,,, "Hexanoic acid, 2-ethyl-, C16-18-alkyl esters",90411-68-0,"Acute oral toxicity:according to OECD 401, in compliance with GLP, RL1 (Pittermann, 1991): LD50>2000 mg/kg bwAcute inhalation toxicity:according to OECD 436, in compliance with GLP, RL1 (Huygevoort, 2010): LC50>5.7 mg/L airAcute dermal toxicity:no data available ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/836098d6-f73b-4d90-a2a8-16c058340c7e/documents/IUC5-0f120e0b-2413-4ebc-8132-ad5a26ed7246_95af7cee-7cb5-4918-9c06-ce8e53719c9b.html,,,,,, "Isononanoic acid, C16-18 (even numbered)-alkyl esters",111937-03-2," Oral (OECD 408), 90 days, rat: NOAEL (systemic) = 100 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5adfeeab-80a7-45e8-a245-2f2789496222/documents/efa57af6-f3d7-4aa0-99d6-07041cd71585_dae14149-9f3d-41e3-a948-80a7e94f4906.html,,,,,, "Isononanoic acid, C16-18 (even numbered)-alkyl esters",111937-03-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5adfeeab-80a7-45e8-a245-2f2789496222/documents/efa57af6-f3d7-4aa0-99d6-07041cd71585_dae14149-9f3d-41e3-a948-80a7e94f4906.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Isononanoic acid, C16-18 (even numbered)-alkyl esters",111937-03-2,Oral (OECD 401): LD50 values > 5000 mg/kg bwInhalation (OECD 436): LC50 > 5.7 mg/L airDermal: no data available ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5adfeeab-80a7-45e8-a245-2f2789496222/documents/b2f83371-d939-4c3f-8153-704aaf0bbf2e_dae14149-9f3d-41e3-a948-80a7e94f4906.html,,,,,, "Hexadecan- l-ol, ethoxylated",9004-95-9," Oral (subacute, rat, m/f, OECD 422): NOAEL (systemic toxicity) ≥ 1000 mg/kg bw/day Oral (subacute, rat, m/f, OECD 422): NOAEL (local toxicity) = 300 mg/kg bw/day Conclusion based on data obtained with hexadecan-1-ol, ethoxylated (CAS No. 9004-95-9, EC No. 500-014-1) and considering all the available data on repeated dose toxicity in the Alcohol Ethoxylates (AE) category, in a Weight-of-Evidence approach. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8983aa0f-d51f-479f-9323-d1a7484144e2/documents/af8a8731-b1bc-473c-872a-660dd7dd1d96_c92365de-c5ee-41dd-afa2-cd8e70609476.html,,,,,, "Hexadecan- l-ol, ethoxylated",9004-95-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8983aa0f-d51f-479f-9323-d1a7484144e2/documents/af8a8731-b1bc-473c-872a-660dd7dd1d96_c92365de-c5ee-41dd-afa2-cd8e70609476.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hexadecan- l-ol, ethoxylated",9004-95-9," Oral: LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute oral toxicity in the Alcohol Ethoxylates (AE) category in a Weight-of-Evidence approach. Inhalation: No study required as the inhalation route of exposure is considered less relevant than the dermal route for AE substances. Dermal: According to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, no study is required as the AE substances do not meet the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8983aa0f-d51f-479f-9323-d1a7484144e2/documents/1dcf55ee-4f45-4031-9b46-3c41571c4494_c92365de-c5ee-41dd-afa2-cd8e70609476.html,,,,,, "Hexadecan- l-ol, ethoxylated",9004-95-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8983aa0f-d51f-479f-9323-d1a7484144e2/documents/1dcf55ee-4f45-4031-9b46-3c41571c4494_c92365de-c5ee-41dd-afa2-cd8e70609476.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alcohols, C16-18 and C18-unsatd., ethoxylated",68920-66-1," Oral (subacute, rat, m/f, OECD 422): NOAEL (systemic toxicity) = 1000 mg/kg bw/day Oral (subacute, rat, m/f, OECD 422): NOAEL (local toxicity) = 300 mg/kg bw/day   Oral (subchronic, rat, m/f, OECD 408): NOAEL (systemic toxicity) = 300 mg/kg bw/day Oral (subchronic, rat, m/f, OECD 408): NOAEL (local toxicity) ≥ 1000 mg/kg bw/day   Conclusion based on data obtained with alcohols, C16-18 and C18 unsatd., ethoxylated (CAS No. 68920-66-1, EC No. 500-016-2) and considering all the available data on repeated dose toxicity in the Alcohol Ethoxylates (AE) category, in a Weight-of-Evidence approach. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ced2efc3-3f37-4657-a7af-0be592343f26/documents/cf4f81c5-272e-4852-9e40-00c557fe6555_53d67a35-3334-415a-8d08-a5435025494c.html,,,,,, "Alcohols, C16-18 and C18-unsatd., ethoxylated",68920-66-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ced2efc3-3f37-4657-a7af-0be592343f26/documents/cf4f81c5-272e-4852-9e40-00c557fe6555_53d67a35-3334-415a-8d08-a5435025494c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Alcohols, C16-18 and C18-unsatd., ethoxylated",68920-66-1," Oral: LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute oral toxicity in the Alcohol Ethoxylates (AE) category in a Weight-of-Evidence approach. Inhalation: No study required as the inhalation route of exposure is considered less relevant than the dermal route for AE substances. Dermal: According to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, no study is required as the AE substances do not meet the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ced2efc3-3f37-4657-a7af-0be592343f26/documents/c86c019f-34fd-4cf2-8974-95dbe14cbed5_53d67a35-3334-415a-8d08-a5435025494c.html,,,,,, "Alcohols, C16-18 and C18-unsatd., ethoxylated",68920-66-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ced2efc3-3f37-4657-a7af-0be592343f26/documents/c86c019f-34fd-4cf2-8974-95dbe14cbed5_53d67a35-3334-415a-8d08-a5435025494c.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Cetrimonium bromide,57-09-0,"Oral Key study An OECD TG 422, Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test were performed to determine the potential toxic effects of FeF Cetyl Trimethyl Ammonium Bromide (CTAB) USP/NF when given orally by gavage for a minimum of 28 days to Wistar Han rats and to evaluate the potential to affect male and female reproductive performance.In addition, parental, reproduction (up to and including implantation) and developmental (from implantation onwards) No Observed Adverse Effect Levels (NOAELs) were evaluated.The dose levels in this study were selected to be 0, 5, 15 and 50 mg/kg/day, based on the results of the Dose Range Finder (Test Facility Reference No. 20212914, see Appendix 6, Appendix 7 and Appendix 8). In this Dose Range Finding Study, severe adverse local effects in the stomach were seen at dose levels above 50 mg/kg/day. The following parameters and end points were evaluated in this study: mortality/ moribundity, clinical signs, functional observations, body weight and food consumption, estrous cycle determination, clinical pathology, measurement of thyroid hormone T4 (F0-males), gross necropsy findings, organ weights and histopathologic examinations.  No adverse parental effects were recorded up to the highest dose level tested (50 mg/kg/day). At 50 mg/kg/day, a non-adverse lower grip strength of the hindlimbs was recorded for males. Forelimb grip strength, however, was considered unaffected by treatment with the test item. Also, a non-adverse lower motor activity was recorded for females at 50 mg/kg/day (for ambulations, i.e. relocation of the entire body position like walking). However, total movements (all movements made by the animals, including ambulations but also smaller or more fine movements like grooming, weaving or movements of the head) were considered not affected by treatment with the test item. Also, motor activity habituation pattern appeared similar to the concurrent control group. These changes in grip strength and motor activity were recorded in opposite sexes and were not associated with concurrent clinical signs or histopathological changes in examined muscle and neuronal tissues. It was therefore considered that these variations did not represent an adverse effect on neurobehavior of these animals. Motor activity and grip strength at 5 and 15 mg/kg/day were considered not to be affected by treatment with the test item.Non-adverse but treatment-related changes in body weight and food intake were recorded at 50 mg/kg/day. A lower mean body weight (gain) was recorded for males (throughout treatment) and females (post-coitum) This was accompanied by a slightly lower food consumption during Weeks 1 and 2 of treatment (males and females), and post-coitum (females). Body weights and food consumption at 5 and 15 mg/kg/day were considered not affected by treatment with the test item. Other treatment-related in-life findings were confined to piloerection recorded for all females at 50 mg/kg/day on Day 1 of treatment, and occasionally also during Weeks 4 to 6 of the study. Given the slight magnitude of these findings, these were considered not to represent an adverse effect of the test item.Non-adverse but treatment-related changes in clinical biochemistry parameters at 50 mg/kg/day consisted of slightly higher alanine and aspartate aminotransferase activities (males and females), and inorganic phosphate (males) and calcium concentration (females). There was no apparent correlation between higher alanine and aspartate aminotransferase activities recorded at 50 mg/kg/day and higher liver weights recorded for females at 50 mg/kg/day. These enzyme activity increases were slightly more pronounced in the opposite sex, i.e. males, for which liver weights were similar to the control mean. Overall, the higher liver weight for females at 50 mg/kg/day was considered not related to treatment with the test item in absence of a clear dose-related trend and microscopic correlates. Clinical biochemistry parameters at 5 and 15 mg/kg/day were considered not to be affected by treatment with the test item.Test item-related increased apoptosis of lymphocytes (mainly cortical) of the thymus was recorded in males at 50 mg/kg/day. As there was no macroscopic correlate or related organ weight change and at the recorded low degree, this finding was regarded non-adverse.No local stomach effect were recorded in the Main study up to the highest dose level administered (50 mg/kg/day). In the Dose Range Finding study, local stomach effects were recorded at dose levels higher than the maximum dose level administered in the Main study (i.e. at 100 mg/kg/day and higher).No test item-related mortality occurred.  No treatment-related changes were noted in any of the other parameters investigated in this study (i.e. functional observations (hearing ability, pupillary reflex and static righting reflex), hematology and coagulation parameters, male total T4 thyroid hormone levels and macroscopic examination).   In a supporting oral 1-year study rats were dosed via drinking water with cetrimonium bromide at 0; 10; 20 and 45 mg/kg bw/d. No histopathological findings were observed in the stomach (only organ subject to histopathological examination). At 45 mg/kg bw/d significant and persistent decrease in body weight was observed in male which was suggested to be due to lower observed efficiency of food conversion. The authors concluded that cetrimonium bromide may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or interfering with absorption of nutritional substances.   No dermal studies are available for cetrimonium bromide.    For the read-across substance cetrimonium chloride a NOAEL of 10 mg/kg bw/d was concluded in an evaluation performed by SSCS. In the 28D dermal study with rabbits dosed on 25% of their body surface with 10 mg/kg bw/d (2 ml/kg bw/d) no systemic effects were noted. However, the exposed skin showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate. Thus, local effects on skin were observed at this dose level.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch score 2 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1844aa47-9930-4c37-bc21-7a07dbd29c80/documents/IUC5-5af04e96-93f3-4ac2-9b5e-7d93d11becae_b94a514d-37a6-46d3-8743-0a2dbfd4742b.html,,,,,, Cetrimonium bromide,57-09-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1844aa47-9930-4c37-bc21-7a07dbd29c80/documents/IUC5-5af04e96-93f3-4ac2-9b5e-7d93d11becae_b94a514d-37a6-46d3-8743-0a2dbfd4742b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Cetrimonium bromide,57-09-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1844aa47-9930-4c37-bc21-7a07dbd29c80/documents/IUC5-5af04e96-93f3-4ac2-9b5e-7d93d11becae_b94a514d-37a6-46d3-8743-0a2dbfd4742b.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rabbit Cetrimonium bromide,57-09-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1844aa47-9930-4c37-bc21-7a07dbd29c80/documents/IUC5-5af04e96-93f3-4ac2-9b5e-7d93d11becae_b94a514d-37a6-46d3-8743-0a2dbfd4742b.html,Repeated dose toxicity – local effects,dermal,LOAEL,0.05 mg/cm2,adverse effect observed,rabbit Cetrimonium bromide,57-09-0,Read-across from data on acute oral and acute dermal toxicity on cetrimonium chloride  indicates that cetrimonium bromide should be classified as Acute tox 4 for acute oral toxicity based on LD50 values for cetrimonium chloride in the range of 465 - 891 mg/kg bw.  A dermal LD50 value of 4.3 ml/kg bw was found  (corresponding to 2150 mg/kg bw ) which is above the CLP classification criteria.A 30 minutes inhalation study with mice indicates pulmonary irritation as dose-related reduced tidal volume and increase in respiratory frequency was found with a LOEC of 1.8 mg cetrimonium bromide/m3 and a NOEC of 0.57 mg cetrimonium bromide/m3 .  Initial signs of pulmonary inflammation were found at 19 mg cetrimonium bromide/m3 based on an increase in macrophages in BAL. Thus it is considered relevant to apply classification with STOT SE3; H335. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1844aa47-9930-4c37-bc21-7a07dbd29c80/documents/IUC5-dfcf5a34-a5b0-41de-a8b8-4c14b338c1ac_b94a514d-37a6-46d3-8743-0a2dbfd4742b.html,,,,,, Cetrimonium bromide,57-09-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1844aa47-9930-4c37-bc21-7a07dbd29c80/documents/IUC5-dfcf5a34-a5b0-41de-a8b8-4c14b338c1ac_b94a514d-37a6-46d3-8743-0a2dbfd4742b.html,,oral,LD50,465 mg/kg bw,adverse effect observed, Cetrimonium bromide,57-09-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1844aa47-9930-4c37-bc21-7a07dbd29c80/documents/IUC5-dfcf5a34-a5b0-41de-a8b8-4c14b338c1ac_b94a514d-37a6-46d3-8743-0a2dbfd4742b.html,,dermal,LD50,"2,150 mg/kg bw",adverse effect observed, Cetrimonium bromide,57-09-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1844aa47-9930-4c37-bc21-7a07dbd29c80/documents/IUC5-dfcf5a34-a5b0-41de-a8b8-4c14b338c1ac_b94a514d-37a6-46d3-8743-0a2dbfd4742b.html,,inhalation,discriminating conc.,1.8 mg/m3,adverse effect observed, Cetrimonium chloride,112-02-7," Overall, considering the repeated dose studies with the test and read across substances (Coco TMAC and C16 TMAB), the main critical effects associated with these substances were due to their corrosive properties. The systemic effects such as the reduction of body weight and food consumption were considered to be secondary compared to the corrosive properties of the substances. Therefore, in the absence of ‘true’ systemic effects and in line with the biocides assessment reports, the derivation of a systemic DNEL has been considered to be non-relevant and only a qualitative local risk assessment has been conducted for the test substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b65d9f03-e0db-4dcc-8017-d068879d8301/documents/9d36b000-ffd2-42f7-b241-f03f2a4719b0_ffd59a67-2303-4c7e-a925-01c1a1cf175a.html,,,,,, Cetrimonium chloride,112-02-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b65d9f03-e0db-4dcc-8017-d068879d8301/documents/9d36b000-ffd2-42f7-b241-f03f2a4719b0_ffd59a67-2303-4c7e-a925-01c1a1cf175a.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rabbit Cetrimonium chloride,112-02-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b65d9f03-e0db-4dcc-8017-d068879d8301/documents/9d36b000-ffd2-42f7-b241-f03f2a4719b0_ffd59a67-2303-4c7e-a925-01c1a1cf175a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40.3 mg/kg bw/day,,rat Cetrimonium chloride,112-02-7,"The oral LD50 value of the test substance was determined to be 699 mg a.i./kg bw in rats, suggesting a moderate acute toxicity potential. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b65d9f03-e0db-4dcc-8017-d068879d8301/documents/IUC5-820d488d-d5d4-48cd-991a-d6b5732453b2_ffd59a67-2303-4c7e-a925-01c1a1cf175a.html,,,,,, Cetrimonium chloride,112-02-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b65d9f03-e0db-4dcc-8017-d068879d8301/documents/IUC5-820d488d-d5d4-48cd-991a-d6b5732453b2_ffd59a67-2303-4c7e-a925-01c1a1cf175a.html,,oral,LD50,699 mg/kg bw,adverse effect observed, Hexadecyltrimethylammonium methyl sulphate,65060-02-8," Overall, considering the repeated dose studies with the read across substances (e.g., Coco TMAC) as mentioned in the Biocides assessment report, the main critical effects associated with these substances were due to their corrosive properties. The systemic effects such as the reduction of body weight and food consumption were considered to be secondary compared to the corrosive properties of the substances. Therefore, in the absence of ‘true’ systemic effects and in line with the biocides assessment reports, the derivation of a systemic DNEL has been considered to be non-relevant and only a qualitative local risk assessment has been conducted for the test substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a7a1a06-0896-48c5-bd56-9a338e93551d/documents/a940890e-92c8-47a3-820f-b3e136ea3be6_00a8f59a-eda7-4c96-91f8-5eeaf217940d.html,,,,,, Hexadecyltrimethylammonium methyl sulphate,65060-02-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a7a1a06-0896-48c5-bd56-9a338e93551d/documents/a940890e-92c8-47a3-820f-b3e136ea3be6_00a8f59a-eda7-4c96-91f8-5eeaf217940d.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rabbit Hexadecyltrimethylammonium methyl sulphate,65060-02-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a7a1a06-0896-48c5-bd56-9a338e93551d/documents/a940890e-92c8-47a3-820f-b3e136ea3be6_00a8f59a-eda7-4c96-91f8-5eeaf217940d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40.3 mg/kg bw/day,,rat Hexadecyltrimethylammonium methyl sulphate,65060-02-8," Based on the results of the read across study, the acute LD50 of the test substance in male/female rats for the test substance is considered to be >600 mg/kg bw (i.e., 570 mg a.i./kg bw). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a7a1a06-0896-48c5-bd56-9a338e93551d/documents/ad8f164a-94d7-44ca-9a92-a286def7ac58_00a8f59a-eda7-4c96-91f8-5eeaf217940d.html,,,,,, Hexadecyltrimethylammonium methyl sulphate,65060-02-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a7a1a06-0896-48c5-bd56-9a338e93551d/documents/ad8f164a-94d7-44ca-9a92-a286def7ac58_00a8f59a-eda7-4c96-91f8-5eeaf217940d.html,,oral,LD50,570 mg/kg bw,adverse effect observed, Hexadecyltrimethylammonium toluene-p-sulphonate,138-32-9, In an acute oral toxicity study in rats Toluene-4 -sulphonic acid was found to have an LD50 of 1410 mg/kg bw. The NOAEL is 1250 mg/kg/bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5d0842f-4ea2-4333-ab95-7af4ad904605/documents/5a53453d-6651-47cb-b983-3843ee92256a_7ef8e3ca-e927-42cc-ad77-e7a7625887e8.html,,,,,, Hexadecyltrimethylammonium toluene-p-sulphonate,138-32-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5d0842f-4ea2-4333-ab95-7af4ad904605/documents/5a53453d-6651-47cb-b983-3843ee92256a_7ef8e3ca-e927-42cc-ad77-e7a7625887e8.html,,oral,LD50,"1,410 mg/kg bw",adverse effect observed, Hexadecyl acetate,629-70-9,The test item is a waxy solid that is used in the neat state exclusively as a cosmetic ingredient under industrial conditions. No evidence of systemic toxicity or local effects has been reported in acute studies and long-term investigations involving vertebrate animals are not appropriate. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb172ad4-19cb-4a04-8633-0b22b49528ef/documents/IUC5-a8c8a476-3603-42db-8a20-42487fa8d77d_c2947609-b053-4290-a893-c09c1b266747.html,,,,,, Hexadecyl acetate,629-70-9,No toxicity reported following oral or dermal administration of the test item (LD50 oral 40.0 mL/kg using a preparation declared to contain 90 % of test item; LD50 dermal > 5000 mg/kg). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb172ad4-19cb-4a04-8633-0b22b49528ef/documents/IUC5-03b1190c-ad86-4b34-ac4e-d62abd68505f_c2947609-b053-4290-a893-c09c1b266747.html,,,,,, Hexadecan-1-ol,36653-82-4,"  In the key study, no adverse effects were seen after dietary administration of a reliable 13-week oral feeding study in rats using hexadecan-1-ol, resulting in a NOAEL value of >4400 mg/kg bw/day. (Scientific Assoc, 1966a; rel. 2) In addition read-across from a reliable 28 day oral gavage study in rats using hexadecan-1-ol reported a NOAEL value of >1000 mg/kg bw/day (Henkel, 1985a; rel. 2). A 4-week reliable oral study in rats using octadecan-1-ol reported a NOAEL value of 1000 mg/kg bw/day, the highest dose tested (Henkel, 1986a; rel. 1). A reliable 26-week oral gavage study in rats using docosan-1-ol reported no adverse effects at the highest dose tested, 1000 mg/kg bw/day (Iglesias et al., 2002a). Further supporting data come from a 90-day feeding study in rats with of alcohols, C14-15-branched and linear (Ito et al., 1978) which reported a NOAEL value of >3548 mg/kg bw/day. Read-across data from a reliable 13-week dietary study in rats using hexan-1-ol reported a NOAEL of 1127 mg/kg bw/day (Scientific Associates Inc., 1966). No adverse effects were noted at any of the dose levels administered during the study. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f5d5fcc-c773-4ce6-8d45-fdaf999c2992/documents/09748988-a30f-4d82-a0e9-f090fe8001b6_9eaeb762-6650-46f2-bf58-f4c241687779.html,,,,,, Hexadecan-1-ol,36653-82-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f5d5fcc-c773-4ce6-8d45-fdaf999c2992/documents/09748988-a30f-4d82-a0e9-f090fe8001b6_9eaeb762-6650-46f2-bf58-f4c241687779.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"4,400 mg/kg bw/day",,rat Hexadecan-1-ol,36653-82-4," The key acute oral toxicity study for hexadecan-1-ol, conducted according to the now-deleted OECD Test Guideline 401 and in compliance with GLP, reports an LD50 value of >2000mg/kg (Safepharm Laboratories, 1996; rel 1). There are no acute inhalation and acute dermal toxicity data for hexadecan-1-ol. Therefore, data are read-across from tetradecan-1-ol. The key acute inhalation toxicity study with tetradecan-1-ol, conducted prior to OECD Test Guideline and GLP, reports an LC50 of >1.5 mg/L air in rat, following 1-hour whole body inhalation exposure to vapour, which is the equivalent to 0.375 mg/L for a 4-hour exposure (Scientific Associates, 1977; rel 2). The key acute dermal toxicity study for tetradecan-1-ol, conducted prior to OECD Test Guideline and GLP, reports an LD50 value of 8000-12000 mg/kg bw in rabbit (Scientific Associates 1977; rel 2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f5d5fcc-c773-4ce6-8d45-fdaf999c2992/documents/66c9d025-39ac-4540-95d8-dd611a51ca78_9eaeb762-6650-46f2-bf58-f4c241687779.html,,,,,, Hexadecan-1-ol,36653-82-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f5d5fcc-c773-4ce6-8d45-fdaf999c2992/documents/66c9d025-39ac-4540-95d8-dd611a51ca78_9eaeb762-6650-46f2-bf58-f4c241687779.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Hexadecan-1-ol,36653-82-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f5d5fcc-c773-4ce6-8d45-fdaf999c2992/documents/66c9d025-39ac-4540-95d8-dd611a51ca78_9eaeb762-6650-46f2-bf58-f4c241687779.html,,dermal,LD50,"8,000 mg/kg bw",no adverse effect observed, Hexadecan-1-ol,36653-82-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f5d5fcc-c773-4ce6-8d45-fdaf999c2992/documents/66c9d025-39ac-4540-95d8-dd611a51ca78_9eaeb762-6650-46f2-bf58-f4c241687779.html,,inhalation,LC50,"1,500 mg/m3",no adverse effect observed, (carboxylatomethyl)hexadecyldimethylammonium,693-33-4," Other than slight clinical chemistry changes observed in high dose animals; no gross or histologic alterations, including to reproductive organs, attributed to test material (cetyl betaine) were observed. In addition, reviews by US EPA on the class of substance (surrogate betaines) demonstrate that toxicity for this class is limited to GI tract irritation with no evidence of specific organ toxicity. In view of the primary use in cosmetics, further animal testing can not be justifed. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9d04e1b-ea0c-49f7-b2e0-6d971aab4e17/documents/71224070-18f4-422f-8121-e1fd21795608_13cc52b2-d100-41d3-bbe1-5ad2b45dd6b1.html,,,,,, Hexadecyl 2-ethylhexanoate,59130-69-7,"A 28 -day study (BASF, 1993) with the structural analogue Fatty acids, C8 -10, C12 -18 -alkyl esters is available, where no adverse effects were found revealing a NOAEL of 1000 mg/kg bw (highest dose tested). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9636ab07-7c9c-41ef-9c23-92630fbafa86/documents/IUC5-e8815990-59d4-42a1-b31b-61ef00c399f9_42536141-3227-45a4-a07d-0c414ea19c1e.html,,,,,, Hexadecyl 2-ethylhexanoate,59130-69-7,"Acute oral toxicity:according to OECD 401, in compliance with GLP, RL1 (Pittermann, 1991): LD50>2000 mg/kg bwAcute inhalation toxicity:according to OECD 436, in compliance with GLP, RL1 (Huygevoort, 2010): LC50>5.7 mg/L air.Acute dermal toxicity:No data available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9636ab07-7c9c-41ef-9c23-92630fbafa86/documents/IUC5-951a3ad7-6c45-4bbb-984b-81d29480ee05_42536141-3227-45a4-a07d-0c414ea19c1e.html,,,,,, Hexadecyl lactate,35274-05-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Low (not assignable). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Based on tests with shorter chain alkyl lactates. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Based on tests with shorter chain alkyl lactates. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): Low (not assignable). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9358c234-931e-4f1b-a6c4-3aef080ae002/documents/233d79c5-02f7-4129-aae9-5421f2f4e283_6ffd6f1b-46b1-4c45-b06c-d7bf72466c6d.html,,,,,, Hexadecyl lactate,35274-05-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9358c234-931e-4f1b-a6c4-3aef080ae002/documents/233d79c5-02f7-4129-aae9-5421f2f4e283_6ffd6f1b-46b1-4c45-b06c-d7bf72466c6d.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rat Hexadecyl lactate,35274-05-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9358c234-931e-4f1b-a6c4-3aef080ae002/documents/233d79c5-02f7-4129-aae9-5421f2f4e283_6ffd6f1b-46b1-4c45-b06c-d7bf72466c6d.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,600 mg/m3,,rat Hexadecyl lactate,35274-05-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9358c234-931e-4f1b-a6c4-3aef080ae002/documents/233d79c5-02f7-4129-aae9-5421f2f4e283_6ffd6f1b-46b1-4c45-b06c-d7bf72466c6d.html,Repeated dose toxicity – local effects,inhalation,NOAEC,200 mg/m3,adverse effect observed,rat Hexadecyl lactate,35274-05-6," Justification for selection of acute toxicity – oral endpoint: Key studies performed with products containing hexadecyl lactate or C12 -C16 (even) lactates. Ceraphyl®28 containing C16 lactate, Ceraphyl®31 containing C12 -C16 (even) lactates and Ceraphyl®41 containing C12 -C15 lactates all have an oral LD50 of 20,000 mg/kg - inhalation endpoint: The inhalation LC50 of lactate esters is generally above 5000 mg/m3. – dermal endpoint: A combination of dodecyl and tridecyl lactates, linear and branched, proved to be non-toxic. Supporting test with other alkyl lactates confirm the low acute dermal toxicity of the product for registration. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9358c234-931e-4f1b-a6c4-3aef080ae002/documents/IUC5-4d7739d4-73d9-44a1-8e32-3ed9937a94bb_6ffd6f1b-46b1-4c45-b06c-d7bf72466c6d.html,,,,,, Hexadecyl lactate,35274-05-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9358c234-931e-4f1b-a6c4-3aef080ae002/documents/IUC5-4d7739d4-73d9-44a1-8e32-3ed9937a94bb_6ffd6f1b-46b1-4c45-b06c-d7bf72466c6d.html,,oral,LD50,"20,000 mg/kg bw",no adverse effect observed, Hexadecyl palmitate,540-10-3," Oral (OECD 422, read across): NOAEL m/f rat ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ad0e83d-79fe-4d6f-9132-c73fce8699fd/documents/2a8c7740-f1c4-43cf-9bda-465a73bb929a_8ae3a4fb-58db-4c99-9846-ebfc93551261.html,,,,,, Hexadecyl palmitate,540-10-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ad0e83d-79fe-4d6f-9132-c73fce8699fd/documents/2a8c7740-f1c4-43cf-9bda-465a73bb929a_8ae3a4fb-58db-4c99-9846-ebfc93551261.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Hexadecyl palmitate,540-10-3," Oral (similar to OECD 401): LD50 m/f rat > 2000 mg/kg bw Dermal (read across, OECD 404): LD50 m/f rat > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ad0e83d-79fe-4d6f-9132-c73fce8699fd/documents/66a534f4-a1e9-4665-b4b6-ef550c8d1f85_8ae3a4fb-58db-4c99-9846-ebfc93551261.html,,,,,, Hexadecyl dihydrogen phosphate,3539-43-3," Five male and 5 female Fü-albino SPF rats were randomly selected for an acute oral toxicity study. Fasted rats were given a single dose of the test substance suspended in SSV (Standard Suspended Vehicle) by gavage at a dose level of 5000 mg/kg bw. They were observed for 15 days for toxic signs, mortality and body weight changes. All rats were examined for gross lesions. The LD50 value determined for the test substance in rats was greater than 5000 mg/kg bw. No compound-related deaths occurred. No compound-related incompatibility reactions were observed. No compound-related effect on body weight development appeared. No compound-related gross or microscopic lesions were observed. The substance that has been tested for this end point is the potassium salt of the hexadecyl hydrogen phosphate. Once in biological situations, and in particular stomach acid solution, the potassium ion will dissociate from the substance leaving the hexadecyl dihydrogen phosphate anion as the organic species that will be present in situ. This is the same as the substance under consideration and thus read-across is considered totally valid. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1942a875-85d7-4b54-ba1b-c8cd6b0c44ce/documents/4f17a774-16ba-453b-bfed-b8e49a11a92b_148e9210-d216-40cb-8f07-0f70da27b856.html,,,,,, Hexadecyl dihydrogen phosphate,3539-43-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1942a875-85d7-4b54-ba1b-c8cd6b0c44ce/documents/4f17a774-16ba-453b-bfed-b8e49a11a92b_148e9210-d216-40cb-8f07-0f70da27b856.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Hexadecyl (R)-12-hydroxyoleate,10401-55-5,"Oral: OECD 422, rat, NOAEL ≥ 1000 mg/kg bw/day   The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the LCAE category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available, and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the LCAE category. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f1147b4-5f3f-42ba-a0b3-1ce621d77cc8/documents/IUC5-3eca23fe-2e0e-449d-bf58-706d95fbe87e_55638017-734f-45fd-a0c1-57417bde0909.html,,,,,, Hexadecyl (R)-12-hydroxyoleate,10401-55-5,"Oral: LD50 > 2000 mg/kg bw Inhalation: LC50 > 5.7 mg/LDermal: LD50 > 2000 mg/kg bw   The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the LCAE category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available, and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the LCAE category. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f1147b4-5f3f-42ba-a0b3-1ce621d77cc8/documents/IUC5-48767df4-a6f5-48c5-ad0d-f3dac56e0b9a_55638017-734f-45fd-a0c1-57417bde0909.html,,,,,, Hexadecyltrimethoxysilane,16415-12-6," RDT oral (OECD TG 408, GLP), rat: NOAEL = 100 mg/kg bw/day RDT inhalation: no data available RDT dermal: no data available ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c600fc41-c737-4de6-b8a1-2f4379df7509/documents/88d3da40-13fe-44b5-8697-948a4757ca6d_6162ea1a-c776-433e-b02d-e6139e1944e4.html,,,,,, Hexadecyltrimethoxysilane,16415-12-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c600fc41-c737-4de6-b8a1-2f4379df7509/documents/88d3da40-13fe-44b5-8697-948a4757ca6d_6162ea1a-c776-433e-b02d-e6139e1944e4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Hexadecyltrimethoxysilane,16415-12-6,"Acute oral toxicity (OECD TG 423, GLP): LD50>2000 mg/kg bwAcute inhalation toxicity: data waiver according to Column 2 of REACH Annex VIIIAcute dermal toxicity: data waiver according to Column 2 of REACH Annex VIII ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c600fc41-c737-4de6-b8a1-2f4379df7509/documents/34d6a541-13cb-44af-9342-0cdac315ba98_6162ea1a-c776-433e-b02d-e6139e1944e4.html,,,,,, Cetylpyridinium chloride,123-03-5,CPC demonstrates local irritation when administered orally to rats in a chronic study. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b06f806-8b18-4c0f-9847-d6581189e6f1/documents/IUC5-4503d2c4-6130-4144-8674-54709d94b392_9ac3ef94-0ad9-4df6-824e-f37870fc3290.html,,,,,, Cetylpyridinium chloride,123-03-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b06f806-8b18-4c0f-9847-d6581189e6f1/documents/IUC5-4503d2c4-6130-4144-8674-54709d94b392_9ac3ef94-0ad9-4df6-824e-f37870fc3290.html,Chronic toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat Cetylpyridinium chloride,123-03-5,"The oral LD50 of CPC is 560 mg/kg bw, and the inhalation LC50 is between 0.054 and 0.51 mg/L or 54 to 510 mg/m3. The dermal LD50 is greater than 5000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b06f806-8b18-4c0f-9847-d6581189e6f1/documents/IUC5-d96e0cca-681c-4d64-b902-cf2134798323_9ac3ef94-0ad9-4df6-824e-f37870fc3290.html,,,,,, Cetylpyridinium chloride,123-03-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b06f806-8b18-4c0f-9847-d6581189e6f1/documents/IUC5-d96e0cca-681c-4d64-b902-cf2134798323_9ac3ef94-0ad9-4df6-824e-f37870fc3290.html,,oral,LD50,560.3 mg/kg bw,adverse effect observed, Cetylpyridinium chloride,123-03-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b06f806-8b18-4c0f-9847-d6581189e6f1/documents/IUC5-d96e0cca-681c-4d64-b902-cf2134798323_9ac3ef94-0ad9-4df6-824e-f37870fc3290.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Cetylpyridinium chloride,123-03-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b06f806-8b18-4c0f-9847-d6581189e6f1/documents/IUC5-d96e0cca-681c-4d64-b902-cf2134798323_9ac3ef94-0ad9-4df6-824e-f37870fc3290.html,,inhalation,LC50,54 mg/m3,adverse effect observed, "Matricaria recutita, ext.",84082-60-0," In an acute oral toxicity study, the oral LD50 of Essential oil of Blue Chamomilla was higher than 5000 mg/kg bw in rats (Rel. K2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5460ba5-10e1-48a2-9582-35cb54a88cb9/documents/76ca789f-a625-4403-8084-098b496e8ef5_5bb1bb96-e3ab-4077-bfeb-971c0b825aff.html,,,,,, "Matricaria recutita, ext.",84082-60-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5460ba5-10e1-48a2-9582-35cb54a88cb9/documents/76ca789f-a625-4403-8084-098b496e8ef5_5bb1bb96-e3ab-4077-bfeb-971c0b825aff.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Charcoal,16291-96-6,"Due to the low water solubiliy of the UVCB substance, systemic exposure via the oral and dermal routes is not expected. Some exposure to inhalable charcoal particles (< 100 µm), in particular during manufacturing and (re)packing, cannot be ruled out. Inhaled charcoal particles may produce a slight inflammatory response of the lungs.   Thus, to account for the information requirements according to Annex X of Regulation (EC) 1907/2006 a weight-of-evidence approach is chosen. It is based on epidemiological data on the consequences of charcoal dust exposure of workers as well as published clinical case reports. Moreover, the actual discussion about the chronic inhalation toxicity of poorly soluble low toxicity particles such as carbon black and coal particles is reflected. Finally, a species comparative sub-chronic inhalation toxicity study with carbon black in rats, mice and hamsters is summarized. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/736475be-6dea-4684-917e-3e464d9acc9b/documents/65522494-bfb1-44e5-a2b3-51595ffb03f2_5c51a2e5-f8a8-4bd7-bd3b-2b0b077470f1.html,,,,,, Charcoal,16291-96-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/736475be-6dea-4684-917e-3e464d9acc9b/documents/65522494-bfb1-44e5-a2b3-51595ffb03f2_5c51a2e5-f8a8-4bd7-bd3b-2b0b077470f1.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,1 mg/m3,,rat Charcoal,16291-96-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/736475be-6dea-4684-917e-3e464d9acc9b/documents/65522494-bfb1-44e5-a2b3-51595ffb03f2_5c51a2e5-f8a8-4bd7-bd3b-2b0b077470f1.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1 mg/m3,adverse effect observed,rat Charcoal,16291-96-6,"The acute inhalative toxicity of charcoal (Probe 2: C-Fix=80.5%) was investigated in a study in rats that was performed according to OECD guideline no. 403, EU method B.2 and the US EPA Health Effects Test guideline OPPTS 870.1300, Acute Inhalation Toxicity, as per August 1998. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/736475be-6dea-4684-917e-3e464d9acc9b/documents/4045287e-9ba8-401d-8b13-72ceaf8bc6a9_5c51a2e5-f8a8-4bd7-bd3b-2b0b077470f1.html,,,,,, Charcoal,16291-96-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/736475be-6dea-4684-917e-3e464d9acc9b/documents/4045287e-9ba8-401d-8b13-72ceaf8bc6a9_5c51a2e5-f8a8-4bd7-bd3b-2b0b077470f1.html,,inhalation,LC50,> 4.97 mg/L,adverse effect observed, Tosylchloramide sodium,127-65-1," There are several studies available for evaluation of which the 90-day in dogs, rats and mice are the longest in duration. Most relevant: Toxicty to reproduction study oral in rats 2 -generation study in rats (OECDTG 416): NOAEL 65 mg/kgbw/d (based on 1000 ppm in diet) due to transient effects on body weights at 3000 ppm (read-across from p-TSA). Other available data: Repeated dose toxicity oral (OECDTG 408) with p-TSA: NOAEL 90-d rat = 3000 ppm (214 mg/kg/day for males; 248 mg/kg/day for females). Repeated dose toxicity oral (OECDTG 409) with p-TSA: NOAEL 90-d dog = 8000 ppm (260 mg/kg/day for males; 255 mg/kg/day for males). Toxicity to reproduction screening study (OECD 422, oral-rat with p-TSA): NOAEL of < 120 mg/kg bw/d. Repeated dose toxicity dermal in rabbits with Halamid (21 -day, comparable to guideline study with acceptable restrictions) : NOEL for systemic effects is 225 mg/kg bw/day NOEL for effects on the skin is 25 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0d7ab93-c869-4cbd-9b83-e87a57fe839f/documents/7563b497-6457-4768-9427-ed92967bd671_941878ab-6352-4c02-be0b-50e425da2b7d.html,,,,,, Tosylchloramide sodium,127-65-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0d7ab93-c869-4cbd-9b83-e87a57fe839f/documents/7563b497-6457-4768-9427-ed92967bd671_941878ab-6352-4c02-be0b-50e425da2b7d.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,225 mg/kg bw/day,,rabbit Tosylchloramide sodium,127-65-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0d7ab93-c869-4cbd-9b83-e87a57fe839f/documents/7563b497-6457-4768-9427-ed92967bd671_941878ab-6352-4c02-be0b-50e425da2b7d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,65 mg/kg bw/day,,rat Tosylchloramide sodium,127-65-1, Acute toxicity oral (OECD TG 401): 381.6 mg/kg bw Acute toxicity dermal (OECD TG 402): not applicable (corrosive to skin) Acute toxicity inhalation (OECD TG 403) : not applicable (corrosive to skin) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0d7ab93-c869-4cbd-9b83-e87a57fe839f/documents/183aec05-e40d-4e09-99c9-89409f743a2b_941878ab-6352-4c02-be0b-50e425da2b7d.html,,,,,, Tosylchloramide sodium,127-65-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0d7ab93-c869-4cbd-9b83-e87a57fe839f/documents/183aec05-e40d-4e09-99c9-89409f743a2b_941878ab-6352-4c02-be0b-50e425da2b7d.html,,oral,LD50,381.6 mg/kg bw,adverse effect observed, Chlorhexidine,55-56-1,"For the oral route a subchronic study in rats (using chlorhexidine digluconate solution in water to achieve the following nominal dose levels (as chlorhexidine base) through administration in drinking water: 50, 100 and 200 mg/kg bw/day). Additionally chronic oral studies have been performed with rats (using 20% chlorhexidine digluconate solution in water to achieve the following nominal dose levels (as chlorhexidine base) through administration in drinking water: 0, 5, 25 and 50 mg/kg bw/day; additional group was dosed with chlorhexidine at 50 mg/kg bw/day and para-chloranilin at 0,125 mg/kg bw/day) and dogs (using 20% chlorhexidine digluconate solution in water to achieve the following nominal dose levels (as chlorhexidine base) through administration in capsules: 0, 0.5, 5 and 40/25 mg/kg bw/d; highest dose was reduced after 28 w). For dermal exposure data from a 13-week study with chlorhexidine diacetate in rabbits as well as from a 13-week bathing study in neonatal rhesus monkeys are taken into consideration. The dose levels expressed as chlorhexidine base administered in this 13-week dermal toxicity study in rabbits were: 0, 250, 500 or 1000 mg/kg bw/d, whereas in the 13-week bathing study in neonatal Rhesus monkeys an 8% (w/v as Chlorhexidine digluconate) was adminstered.Due to the physico-chemical properties of the substance exposure via inhalation is unlikely. Therefore, testing for inhalation toxicity is scientifically not justified. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8547b0ce-ba1b-4d44-9812-eb7333c72043/documents/IUC5-834550f1-6204-4bb7-ba40-52bf050245fb_c43d2f34-3040-4d41-9bf2-a0b59bd864d5.html,,,,,, Chlorhexidine,55-56-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8547b0ce-ba1b-4d44-9812-eb7333c72043/documents/IUC5-834550f1-6204-4bb7-ba40-52bf050245fb_c43d2f34-3040-4d41-9bf2-a0b59bd864d5.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,250 mg/kg bw/day,,rabbit Chlorhexidine,55-56-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8547b0ce-ba1b-4d44-9812-eb7333c72043/documents/IUC5-834550f1-6204-4bb7-ba40-52bf050245fb_c43d2f34-3040-4d41-9bf2-a0b59bd864d5.html,Chronic toxicity – systemic effects,oral,LOAEL,5 mg/kg bw/day,,rat Chlorhexidine,55-56-1,"The acute toxicity of chlorhexidine was tested for the oral and dermal route and in both cases the acute toxicity was low.For the inhalatory route there are no studies available. However, due to the physico-chemical properties of the substance, exposure via inhalation is unlikely. Therefore, testing for acute inhalation toxicity is scientifically not justified. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8547b0ce-ba1b-4d44-9812-eb7333c72043/documents/IUC5-a500fb2b-fcfc-4833-a106-bf7876fd4d1d_c43d2f34-3040-4d41-9bf2-a0b59bd864d5.html,,,,,, Chlorhexidine,55-56-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8547b0ce-ba1b-4d44-9812-eb7333c72043/documents/IUC5-a500fb2b-fcfc-4833-a106-bf7876fd4d1d_c43d2f34-3040-4d41-9bf2-a0b59bd864d5.html,,oral,LD50,"5,000 mg/kg bw",, Chlorhexidine,55-56-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8547b0ce-ba1b-4d44-9812-eb7333c72043/documents/IUC5-a500fb2b-fcfc-4833-a106-bf7876fd4d1d_c43d2f34-3040-4d41-9bf2-a0b59bd864d5.html,,dermal,LD50,"2,815 mg/kg bw",, "D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)",18472-51-0,"For the oral route chronic studies have been performed with rats and dogs. The data base for dermal exposure is more limited, so that additional data (13-week study with chlorhexidine diacetate in rabbits) are taken into consideration.Due to the physico-chemical properties of the substance exposure via inhalation is unlikely. Therefore, testing for inhalation toxicity is scientifically not justified. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a836982-bb92-462f-bdae-64c33d03fab2/documents/IUC5-bf1df6f3-9312-455a-9964-b672c83f5562_5af4b677-f82f-4a07-ac8d-3b2feec9be7e.html,,,,,, "D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)",18472-51-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a836982-bb92-462f-bdae-64c33d03fab2/documents/IUC5-bf1df6f3-9312-455a-9964-b672c83f5562_5af4b677-f82f-4a07-ac8d-3b2feec9be7e.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,360 mg/kg bw/day,,rabbit "D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)",18472-51-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a836982-bb92-462f-bdae-64c33d03fab2/documents/IUC5-bf1df6f3-9312-455a-9964-b672c83f5562_5af4b677-f82f-4a07-ac8d-3b2feec9be7e.html,Chronic toxicity – systemic effects,oral,NOAEL,0.89 mg/kg bw/day,,dog "D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)",18472-51-0,"The acute toxicity of chlorhexidine gluconate was tested for the oral and dermal route and in both cases the acute toxicity was low.For the inhalatory route there are no studies available. However, due to the physico-chemical properties of the substance, exposure via inhalation is unlikely. Therefore, testing for acute inhalation toxicity is scientifically not justified. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a836982-bb92-462f-bdae-64c33d03fab2/documents/IUC5-f00028c2-c777-4493-9a7c-ee2dcf1da574_5af4b677-f82f-4a07-ac8d-3b2feec9be7e.html,,,,,, "D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)",18472-51-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a836982-bb92-462f-bdae-64c33d03fab2/documents/IUC5-f00028c2-c777-4493-9a7c-ee2dcf1da574_5af4b677-f82f-4a07-ac8d-3b2feec9be7e.html,,oral,LD50,"2,000 mg/kg bw",, "D-gluconic acid, compound with N,N''-bis(4-chlorophenyl)-3,12-diimino-2,4,11,13-tetraazatetradecanediamidine (2:1)",18472-51-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a836982-bb92-462f-bdae-64c33d03fab2/documents/IUC5-f00028c2-c777-4493-9a7c-ee2dcf1da574_5af4b677-f82f-4a07-ac8d-3b2feec9be7e.html,,dermal,LD50,"5,000 mg/kg bw",, Chlorhexidine dihydrochloride,3697-42-5," Oral toxicity: No mortality or clinical signs was observed up to 5110 mg/kg bw. Due to no mortality, the LD50 value for male and female animals was estimated to be > 5000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0a26826-23f5-46b0-8b1c-204862671bd4/documents/df4344a6-a77d-4f77-bf7f-c8a8e7f5a937_cf468de0-5260-458d-8fee-a83146612782.html,,,,,, Chlorine dioxide,10049-04-4,"Repeated dose toxicity (oral): NOAEL = 200 mg/L (11.5 mg/kg bw/d) (K, reliability 2) i.e. the highest dose tested Repeated dose toxicity (inhalation): LOAEC = 2.8 mg/m3 (1ppm) (WoE, reliability 4) Repeated dose toxicity (dermal): a repeated dose toxicity study by dermal route does not need to be provided because short term toxicity was already assessed via oral and inhalation route. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73d3f826-c7c0-440f-b259-990f3a33f315/documents/9f9e3c48-6992-462b-b0a5-a3f9ab1a3ec8_f51919ed-79db-40e8-b10f-c2e63324b695.html,,,,,, Chlorine dioxide,10049-04-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73d3f826-c7c0-440f-b259-990f3a33f315/documents/9f9e3c48-6992-462b-b0a5-a3f9ab1a3ec8_f51919ed-79db-40e8-b10f-c2e63324b695.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,11.5 mg/kg bw/day,,rat Chlorine dioxide,10049-04-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73d3f826-c7c0-440f-b259-990f3a33f315/documents/9f9e3c48-6992-462b-b0a5-a3f9ab1a3ec8_f51919ed-79db-40e8-b10f-c2e63324b695.html,Repeated dose toxicity – local effects,inhalation,LOAEC,2.8 mg/m3,adverse effect observed,rat Chlorine dioxide,10049-04-4," Acute Oral toxicity on Chlorine dioxide at 0.2%: LD50 combined: 94 mg/kg bw (K, Reliability 1). Acute Dermal toxicity: not applicable as Chlorine dioxide is classified as corrosive. Acute Inhalation toxicity: - Gas: LC50 combined = 89,6 mg/m3 = 32 ppm (K, Reliability 1) - Solution at 0,6 %: LC50 combined = 6.83 mg 0.6% ClO2 solution/L air/4h as pure ClO2 = 6830 mg/m3 (K, Reliability 2)     Acute Oral toxicity Acute Dermal toxicity Acute Inhalation toxicity Chlorine dioxide Gas1 NC N/A Acute Tox. 1 (H330: Fatal if inhaled) Chloride dioxide [0.5-0.82 %[ aqueous solution Acute Tox. 3* (H301: Toxic if swallowed)² N/A NC3 Chloride dioxide [0.82-1 %[ aqueous solution Acute Tox. 3* (H301: Toxic if swallowed)² N/A Acute Tox. 4 (H332: Harmful if inhaled)3 Chloride dioxide [1-2 %[ aqueous solution Acute Tox. 3* (H301: Toxic if swallowed)² N/A Acute Tox. 4 (H332: Harmful if inhaled)3 1Classification of gas form is provided for information purpose only, as the registered reference substance; but the substance will actually be used only as aqueous solutions generated in situ. ² Existing harmonised classification (Index N°017-026-01-0), as Acute Tox. 3 * considered as a minimum classification in the harmonised entry, no more severe level was identified based on available data. 3According to the study result (Haferkorn, 2012), and applying the classification criteria for acute inhalation toxicity (5 mg/L for mist/aerosol), chlorine dioxide solutions have to be classified as category 4 for acute inhalation toxicity (ATI4) above a concentration limit of 0.82%, based on prorata of concentration according to CLP Regulation (EC) 1272/2008 (6.83 mg/L x 0.6% / 5 mg/L). NC = Not classified N/A: not applicable as Chlorine dioxide is classified as corrosive. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73d3f826-c7c0-440f-b259-990f3a33f315/documents/ea0eb28b-7438-4795-837d-c123abc0c6cc_f51919ed-79db-40e8-b10f-c2e63324b695.html,,,,,, Chlorine dioxide,10049-04-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73d3f826-c7c0-440f-b259-990f3a33f315/documents/ea0eb28b-7438-4795-837d-c123abc0c6cc_f51919ed-79db-40e8-b10f-c2e63324b695.html,,oral,LD50,94 mg/kg bw,adverse effect observed, Chlorine dioxide,10049-04-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73d3f826-c7c0-440f-b259-990f3a33f315/documents/ea0eb28b-7438-4795-837d-c123abc0c6cc_f51919ed-79db-40e8-b10f-c2e63324b695.html,,inhalation,LC50,"6,830 mg/m3",no adverse effect observed, Chloroacetic acid,79-11-8," Key study (NTP): 13 -week study in rats according to OECD 408, LOAEL 30 mg/kg bw (not used in DNEL derivation). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04842417-d17d-4fb7-a8f7-4fcdaab52c23/documents/IUC5-1cffd643-a2dc-40c0-be54-14e0ea034132_4e94aa7f-87b3-48ab-ba61-b4a3ebbc7c80.html,,,,,, Chloroacetic acid,79-11-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04842417-d17d-4fb7-a8f7-4fcdaab52c23/documents/IUC5-1cffd643-a2dc-40c0-be54-14e0ea034132_4e94aa7f-87b3-48ab-ba61-b4a3ebbc7c80.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,30 mg/kg bw/day,,rat Chloroacetic acid,79-11-8," Acute oral toxicity: rat LD50  90 mg/kg bw, standard acute toxicity method Acute dermal toxicity: rat LD50 305 mg/kg bw. Non-guideline, non GLP but similar to standard acute dermal toxicity test Acute inhalation toxicity: rat 4 -h LC50 >1286 mg/m3 (no mortality)  OECD 403, GLP ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04842417-d17d-4fb7-a8f7-4fcdaab52c23/documents/IUC5-25eaebfa-ab74-403c-87de-a166680e477a_4e94aa7f-87b3-48ab-ba61-b4a3ebbc7c80.html,,,,,, Chloroacetic acid,79-11-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04842417-d17d-4fb7-a8f7-4fcdaab52c23/documents/IUC5-25eaebfa-ab74-403c-87de-a166680e477a_4e94aa7f-87b3-48ab-ba61-b4a3ebbc7c80.html,,oral,LD50,90 mg/kg bw,adverse effect observed, Chloroacetic acid,79-11-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04842417-d17d-4fb7-a8f7-4fcdaab52c23/documents/IUC5-25eaebfa-ab74-403c-87de-a166680e477a_4e94aa7f-87b3-48ab-ba61-b4a3ebbc7c80.html,,dermal,LD50,305 mg/kg bw,adverse effect observed, Chlorbutanol,57-15-8," Chlorobutanol has been widely used as sedative-hypnotic agent used for procedural sedation, particularly in the pediatric population, and to treat anxiety, insomnia, and alcohol withdrawal syndrome, preservative in ophthalmic, parenteral, and optic preparations. It is strutural similar to chloral hydrat and has a similar toxicity as this substance. In therapeutic use several symptoms such as CNS depression,ataxia, GI irritation including gastritis and vomiting may occur. Therapeutic doses for adults range from 0.3 to 3g. several studies on animals result in LDo of 200 - 300 mg/kg bw The lethal dosis for humans is estimated 50 -500 mg/kg bw. The key study on rats (Bandman et al) results in an LC50 of 510 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e49fa5cb-0393-47f9-a677-ded0452d6af0/documents/64d8d188-2065-4322-936d-50a4e2648b90_2adbb959-e968-4d6e-b516-e90cd97d50cc.html,,,,,, Chlorbutanol,57-15-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e49fa5cb-0393-47f9-a677-ded0452d6af0/documents/64d8d188-2065-4322-936d-50a4e2648b90_2adbb959-e968-4d6e-b516-e90cd97d50cc.html,,oral,LD50,510 mg/kg bw,adverse effect observed, Chloroform,67-66-3,"Oral route: Repeated dose toxicity studies in laboratory animals identified the liver, kidneys and nasal cavity as the target organs for the toxic potential of chloroform. The lowest LOAEL for hepatotoxicity following repeated oral exposure to chloroform was 15 mg/kg bw/day reported from a 7-year study in dogs. A NOAEL for the mentioned target organs of 34 mg/kg bw/day was determined in female F-344 rats receiving chloroform by oral gavage for three weeks. Inhalation route: The NOAEC for renal lesions, induction of cell proliferation and tumour formation in the kidneys following repeated inhalation exposure of male mice to chloroform vapours for 90 days was 25 mg/m3 (exposure for 5 days a week) or 50 mg/m3 (exposure for 7 days a week).  Distinct nasal lesions in the form of a generalised atrophy of ethmoid turbinates were observed in male and female F-344 rats exposed to 50 mg/m3 for 90 days. In another key 90 -day study in mice, the NOAEC was 10 mg/m3 as changes were observed at the next higher level of 49 mg/m3. A key 90 -day study in rats resulted in a NOAEC of 49 mg/m3. In the chronic inhalation study in mice and rats (Yamamoto, 2002), the LOAEC for nasal changes was 24.5 mg/m3 in mice and 49.5 mg/m3 in rats; a NOAEC of 10 mg/m3 for nasal changes was observed in a 90-day inhalation study (Larson, 1996). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b0c870b-6249-40d1-b67c-9c3becec94de/documents/IUC5-fc288485-9c01-4e0e-bca5-d7b45ce06a33_3242c6ee-14e0-4f05-a5e4-ce82f66f509b.html,,,,,, Chloroform,67-66-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b0c870b-6249-40d1-b67c-9c3becec94de/documents/IUC5-fc288485-9c01-4e0e-bca5-d7b45ce06a33_3242c6ee-14e0-4f05-a5e4-ce82f66f509b.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,15 mg/kg bw/day,,dog Chloroform,67-66-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b0c870b-6249-40d1-b67c-9c3becec94de/documents/IUC5-fc288485-9c01-4e0e-bca5-d7b45ce06a33_3242c6ee-14e0-4f05-a5e4-ce82f66f509b.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,10 mg/m3,,mouse Chloroform,67-66-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b0c870b-6249-40d1-b67c-9c3becec94de/documents/IUC5-fc288485-9c01-4e0e-bca5-d7b45ce06a33_3242c6ee-14e0-4f05-a5e4-ce82f66f509b.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,25 mg/m3,,mouse Chloroform,67-66-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b0c870b-6249-40d1-b67c-9c3becec94de/documents/IUC5-fc288485-9c01-4e0e-bca5-d7b45ce06a33_3242c6ee-14e0-4f05-a5e4-ce82f66f509b.html,Chronic toxicity – systemic effects,oral,LOAEL,15 mg/kg bw/day,,dog Chloroform,67-66-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b0c870b-6249-40d1-b67c-9c3becec94de/documents/IUC5-fc288485-9c01-4e0e-bca5-d7b45ce06a33_3242c6ee-14e0-4f05-a5e4-ce82f66f509b.html,Repeated dose toxicity – local effects,inhalation,NOAEC,10 mg/m3,adverse effect observed,"other:mouse, rat: atrophy of the ethmoid turbinates " Chloroform,67-66-3,"A wide range of acute oral LD50 values has been reported for chloroform in mice (36 to 1366 mg chloroform/kg body weight) and rats (450 to 2000 mg chloroform/kg body weight). Although, the mouse has been considered as the most sensitive species, the proposal for classification is based on a rat study (Chu et al. 1980) as requested by the EU and GHS regulation. In this study, the lowest LD50 of 908 mg/kg/body weight was found in male rats. A wide range of LC50 values has also been reported in mice and rats. An assessment can be made by a weight of evidence approach and the LC50 value determined in Bonnet et al. (1980) (9.17 mg/L/6 hours/ chloroform vapours) can be used to derive a 4-hour inhalation LC50 value of 10.5 mg/L. One dermal toxicity study, however non reliable, indicate that dermal application of a single dose of 3.98 g/kg for 24 hours did not cause mortality in rabbits (Torkelson et al. 1976). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b0c870b-6249-40d1-b67c-9c3becec94de/documents/IUC5-a7cde6d0-5a77-48a7-9038-3b8a2cce28c7_3242c6ee-14e0-4f05-a5e4-ce82f66f509b.html,,,,,, Chloroform,67-66-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b0c870b-6249-40d1-b67c-9c3becec94de/documents/IUC5-a7cde6d0-5a77-48a7-9038-3b8a2cce28c7_3242c6ee-14e0-4f05-a5e4-ce82f66f509b.html,,oral,LD50,908 mg/kg bw,adverse effect observed, Chloroform,67-66-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b0c870b-6249-40d1-b67c-9c3becec94de/documents/IUC5-a7cde6d0-5a77-48a7-9038-3b8a2cce28c7_3242c6ee-14e0-4f05-a5e4-ce82f66f509b.html,,inhalation,LC50,"10,500 mg/m3",adverse effect observed, Clorofene,120-32-1,"oral according to US-EPA Guideline 83-2, rat, 2 years, 5d/week, oral gavage,NOAEL (males) < 30 mg/kg bw/d, LOAEL = 30 mg/kg bw/d (males), NOAEL (females) = 60 mg/kg bw/d based on kidney effects, LOAEL (females) = 120 mg/kg bw/d (Hejtmancik 1988a)   dermal similar to OECD Guideline 410, rabbit, 3 weeks, exposure on 5d/week for 6h/d, Systemic effects: LOAEL = 40 mg/kg bw/day (based on kidney effects in ♀)NOAEL = 10 mg/kg bw/day Local effects:All animals treated with >=40 mg/kg bw of chlorophene developed skin changes.LOAEL = 40 mg/kg bw/dayNOAEL = 10 mg/kg bw/day (Krötlinger 1985) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6dc541d7-b49b-4082-9674-3e710ec31896/documents/74e66265-5259-4b20-95ae-1d4493d54d50_64b74747-2574-4863-b3f7-e1ecfcc5b1cc.html,,,,,, Clorofene,120-32-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6dc541d7-b49b-4082-9674-3e710ec31896/documents/74e66265-5259-4b20-95ae-1d4493d54d50_64b74747-2574-4863-b3f7-e1ecfcc5b1cc.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rabbit Clorofene,120-32-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6dc541d7-b49b-4082-9674-3e710ec31896/documents/74e66265-5259-4b20-95ae-1d4493d54d50_64b74747-2574-4863-b3f7-e1ecfcc5b1cc.html,Chronic toxicity – systemic effects,oral,LOAEL,30 mg/kg bw/day,,rat Clorofene,120-32-1,"Acute toxicity: oral: Similar to OECD 401, rats, 5 animals/sex/dose, m/f; Doses: 1500, 2500, 3150, 3969, 5000 mg/kg; LD50 (female= most sensitive)= 3852 mg/kg bw (Cummins and Gardner 1983a).   Acute toxicity: dermal: Similar to OECD 402, rats, 5 animals/sex/dose, m/f, Dose: 2000 mg/kg bw; LD50 = > 2000 mg/kg bw (Cummins and Gardner 1983c).  Acute toxicity: inhalation: Similar to OECD 403, rats, 5 animals/sex/dose, m/f, Doses: 2.07, 2.40 and 3.13 mg/L (actual concentration for the active ingredient), LC50 (female= most sensitive sex) = 2.43 mg/L (2430 mg/m³) (Cummins and Gardner 1983b) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6dc541d7-b49b-4082-9674-3e710ec31896/documents/a6b98678-8282-4756-962a-84f4767a9935_64b74747-2574-4863-b3f7-e1ecfcc5b1cc.html,,,,,, Clorofene,120-32-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6dc541d7-b49b-4082-9674-3e710ec31896/documents/a6b98678-8282-4756-962a-84f4767a9935_64b74747-2574-4863-b3f7-e1ecfcc5b1cc.html,,oral,LD50,"3,852 mg/kg bw",adverse effect observed, Clorofene,120-32-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6dc541d7-b49b-4082-9674-3e710ec31896/documents/a6b98678-8282-4756-962a-84f4767a9935_64b74747-2574-4863-b3f7-e1ecfcc5b1cc.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Clorofene,120-32-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6dc541d7-b49b-4082-9674-3e710ec31896/documents/a6b98678-8282-4756-962a-84f4767a9935_64b74747-2574-4863-b3f7-e1ecfcc5b1cc.html,,inhalation,LC50,"2,430 mg/m3",adverse effect observed, Hexachloroplatinic acid,16941-12-1," In an OECD Test Guideline 407 study, to GLP, rats were administered diammonium hexachloroplatinate by gavage for 28 days. The systemic toxicity NOAEL was 10 mg/kg bw/day on the basis of clinical signs of toxicity (including reduced body weight and growth) in the mid and high dose groups (30 and 100 mg/kg bw/day), resulting in morphological changes to the kidneys and stomach (Hansen, 2015a).   In support, in an OECD Test Guideline 421 reproductive/developmental toxicity screening study, rats (12/sex/group) were administered diammonium hexachloroplatinate by oral gavage at doses of 0, 10, 30 or 100 mg/kg bw/day for at least 35 days. The study NOAEL was established to be 30 mg/kg bw/day for systemic toxicity (Hansen, 2015b).   No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c3abc3d-5829-4477-acf8-2845e105af48/documents/abe3c39a-b430-4d08-af92-858ef0e543e6_521560cb-1b82-4422-9cac-0831b6b40726.html,,,,,, Hexachloroplatinic acid,16941-12-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c3abc3d-5829-4477-acf8-2845e105af48/documents/abe3c39a-b430-4d08-af92-858ef0e543e6_521560cb-1b82-4422-9cac-0831b6b40726.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Hexachloroplatinic acid,16941-12-1," The acute oral LD50 value of dihydrogen hexachloroplatinate was determined to be >25 mg/kg bw but <200 mg/kg bw in rats (van Huygevoort, 2002).   No relevant acute dermal or inhalation toxicity data were identified. However, acute toxicity testing is not appropriate as hexachloroplatinic acid is considered corrosive. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c3abc3d-5829-4477-acf8-2845e105af48/documents/6d484043-4031-4c00-8d32-890367b3fdee_521560cb-1b82-4422-9cac-0831b6b40726.html,,,,,, Hexachloroplatinic acid,16941-12-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c3abc3d-5829-4477-acf8-2845e105af48/documents/6d484043-4031-4c00-8d32-890367b3fdee_521560cb-1b82-4422-9cac-0831b6b40726.html,,oral,discriminating dose,50 mg/kg bw,adverse effect observed, "(1E)-1-chloro-3,3,3-trifluoroprop-1-ene",102687-65-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): High, 2 week, 4 week and 13 week inhalation studies all performed according to OECD 412 TG and GLP are available ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c8b6eee-68ac-4f89-9a66-d9faa49e143a/documents/IUC5-2c891381-97a2-4ce2-b83a-1acdbd866f06_556dd358-b2a0-45d1-a821-abceabd38ffe.html,,,,,, "(1E)-1-chloro-3,3,3-trifluoroprop-1-ene",102687-65-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c8b6eee-68ac-4f89-9a66-d9faa49e143a/documents/IUC5-2c891381-97a2-4ce2-b83a-1acdbd866f06_556dd358-b2a0-45d1-a821-abceabd38ffe.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"21,240 mg/m3",,rat "(1E)-1-chloro-3,3,3-trifluoroprop-1-ene",102687-65-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): GLP study conducted according to OECD guideline ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c8b6eee-68ac-4f89-9a66-d9faa49e143a/documents/IUC5-f23d2cbf-99ea-465d-bae9-50cab202d5fb_556dd358-b2a0-45d1-a821-abceabd38ffe.html,,,,,, "(1E)-1-chloro-3,3,3-trifluoroprop-1-ene",102687-65-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c8b6eee-68ac-4f89-9a66-d9faa49e143a/documents/IUC5-f23d2cbf-99ea-465d-bae9-50cab202d5fb_556dd358-b2a0-45d1-a821-abceabd38ffe.html,,inhalation,LC50,"638,000 mg/m3",adverse effect observed, Chlorphenesin,104-29-0, NOEL Chlorphenesin (repeated oral toxicity rat 28 days) = 10 mg/kg bw/day NOAEL Chlorphenesin (repeated oral toxicity rat 28 days) = 100 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f7a7f7d-fcae-4d25-ae4c-35bc34d3a0a3/documents/ade92534-557c-47b2-aa91-f030ff8bb3bf_259d03a9-4f7a-42dc-9a55-cd950296f644.html,,,,,, Chlorphenesin,104-29-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f7a7f7d-fcae-4d25-ae4c-35bc34d3a0a3/documents/ade92534-557c-47b2-aa91-f030ff8bb3bf_259d03a9-4f7a-42dc-9a55-cd950296f644.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Chlorphenesin,104-29-0, LD50 rat oral route = 3000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f7a7f7d-fcae-4d25-ae4c-35bc34d3a0a3/documents/d52b4349-ad46-4107-88ab-b80116f08574_259d03a9-4f7a-42dc-9a55-cd950296f644.html,,,,,, Chlorphenesin,104-29-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f7a7f7d-fcae-4d25-ae4c-35bc34d3a0a3/documents/d52b4349-ad46-4107-88ab-b80116f08574_259d03a9-4f7a-42dc-9a55-cd950296f644.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, Cholesterol,57-88-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): One reliable study available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): One reliable study available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/768a1ca6-0145-4f6f-b283-8f8b94b2c0d6/documents/IUC5-76ba5e7e-b54b-44e9-91f2-bdc116878b56_d51e9284-f5e5-4b74-9d52-8c8e8eddb7d2.html,,,,,, Cholesterol,57-88-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/768a1ca6-0145-4f6f-b283-8f8b94b2c0d6/documents/IUC5-76ba5e7e-b54b-44e9-91f2-bdc116878b56_d51e9284-f5e5-4b74-9d52-8c8e8eddb7d2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Cholesterol,57-88-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/768a1ca6-0145-4f6f-b283-8f8b94b2c0d6/documents/IUC5-76ba5e7e-b54b-44e9-91f2-bdc116878b56_d51e9284-f5e5-4b74-9d52-8c8e8eddb7d2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Choline chloride,67-48-1,"Repeated dose Toxicity: - Chronic (72 weeks + 31 weeks post-observation) study oral (feed), rat (Fischer 344) male (similar to OECD guideline 452): NOAEL > 1200 mg/kg bw/day (highest / only dose tested) - Subchronic (3 – 4 months) study oral (feed and drinking water), rat m/f (similar to OECD Guideline 408): NOAEL = 1300 – 2900 mg/kg bw/day, LOAEL = 3400 – 5000 mg/kg bw/day - Subacute (28 day) study oral (gavage), intraperitoneal and intranasal, mouse (Balb/c) m/f (GLP, OECD guideline 407 / no guideline available): NOEL > 200 mg/kg bw/day (highest / only dose tested) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Three equivalently reliable studies assessed with Klimisch 2 are available to cover the endpoint ""Repeated Dose Toxicity: oral"". Three different study durations are covered, one subacute, one subchronic and one chronic. The former covers the standard information requirements as demanded by REACH Annex IX column 1 No. 8.6.1 (28 days), the latter two ones, which are due to the test duration the more important ones, cover REACH Annex IX column 1 No. 8.6.2 (90 days resp. column 2, chronic). Hence, the available information meets fully the tonnage-driven data requirements of REACH. Additionally, all available studies revealed equivalent, plausible and consistent results over all three durations, i.e. give all no rise to concern of compound-related toxic effects when applying Choline chloride repeatedly and trigger no classification as STOT-RE. So, the whole database is of high quality. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0fad2e34-b01c-4c20-a920-78ad0a4c08a6/documents/IUC5-a0852ee6-7bad-4a0c-882e-8f7cabe7b73c_ec2ea776-5483-4404-b429-04936ec2657d.html,,,,,, Choline chloride,67-48-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0fad2e34-b01c-4c20-a920-78ad0a4c08a6/documents/IUC5-a0852ee6-7bad-4a0c-882e-8f7cabe7b73c_ec2ea776-5483-4404-b429-04936ec2657d.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat Choline chloride,67-48-1," 1) BASF, 1969 - acute oral toxicity, rats, LD50 ca. 5500 mg/kg bw 2) BASF, 1963 - acute oral toxicity, rats, LD50 ca. 3500 mg/kg bw 3) Salazar-Rodriguez/Sosa, 2004 - acute oral toxicity, rats, LD0 >= 2.79 g/kg bw, intermittent total dose LD0 >= 8.37 g/kg bw (3 consecutive days) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fad2e34-b01c-4c20-a920-78ad0a4c08a6/documents/IUC5-5e4403bc-8718-4259-83c2-02c1694ff081_ec2ea776-5483-4404-b429-04936ec2657d.html,,,,,, Choline chloride,67-48-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fad2e34-b01c-4c20-a920-78ad0a4c08a6/documents/IUC5-5e4403bc-8718-4259-83c2-02c1694ff081_ec2ea776-5483-4404-b429-04936ec2657d.html,,oral,LD50,"3,500 mg/kg bw",no adverse effect observed, Chromium,7440-47-3,"Oral Repeated Dose Toxicity: No chronic repeated dose toxicity study with chromium metal is available. However, based on the information available and published in the context of the NTP program (Stout et al., 2010), two chronic repeated dose oral toxicity studies were conducted with chromium picolinate monohydrate using male and female F344/N rats and B6C3F1 mice. The substance was administered ad libitum to groups of 50 male and 50 female F344/N rats in feed at concentrations of 0, 2000, 10000 and 50000 ppm (actually ingested: males: approx. 0, 90, 460 and 2400 mg/kg bw/day; females: approx. 0, 100, 510 and 2630 mg/kg bw/day) for up to 105 weeks. Average daily doses of Cr III, resulting from chromium picolinate monohydrate exposure in the present 3-month studies, ranged from approximately 1 to 500 mg/kg in rats and 2 to 1,500 mg/kg in mice. Average daily doses in the 2-year studies ranged from approximately 10 to 300 mg/kg in rats and 30 to 800 mg/kg in mice. These doses were up to five orders of magnitude higher than those consumed by humans ingesting typical doses of supplements. According to the authors, chromium picolinate monohydrate did not caused treatment-related effects on clinical signs, mortality, body weights, food consumption and histopathology (neoplastic/non-neoplastic). No exposure-related lesions occurred in the 3-month studies on rats or mice. In the 2-year study no neoplasms or non- neoplastic lesions were attributed to exposure to chromium picolinate monohydrate. This finding is supported by a sub-chronic oral repeated dose toxicity study with dichromium trioxide. Thereby, a second study (Ivankovic, 1975) for oral repeated dose toxicity was obtained from a study in which rats were fed chromium (III) oxide baked in bread for 90 days. No signs of toxicity were observed even at the highest dose (for males ca 1368 mg/kg/day and 1216 mg/kg/day for females). Thereby, it was concluded using a read-across approach and considering the chromium measurement during the study, that chromium III does not present a health hazard to either sex. Based on the findings from the 2 -year and 3-months studies, the NOEL (No-Observed-Effect-Level) of chromium picolinate monohydrate in male and female F344/N rats is considered to be > 50000 ppm (males and females : approx. equivalent to 300 mg Cr III/kg bw/) due to the absence of any relevant toxicological effects. Based on the findings from the 2 -year and 3-months studies, the NOEL (No-Observed-Effect-Level) of chromium picolinate monohydrate in male and female B6C3F1 mice is considered to be > 50000 ppm (males and females: approx. equivalent to approx. 800 mg Cr III/kg bw/day) due to the absence of any relevant toxicological effects. No adverse effects could be observed in none of these studies after the administration of chromium picolinate monohydrate and dichromium trioxide, respectively. Inhalation Repeated Dose Toxicity: The LOAEC for inhalation was derived from a guideline subchronic inhalation study with chromium(III) oxide. At the lowest concentration slight inflammation was observed in the lungs. Dermal Repeated Dose Toxicity: Due to the low bioavailability of chromium, the dermal route is not relevant for repeated dose toxicity. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d6d66265-7a8e-414c-af96-aeb34c3b078a/documents/IUC5-dad86a2f-2e89-401e-8451-7f6c0e7cbd12_2e5e06a1-3050-454d-a362-125fc3c00779.html,,,,,, Chromium,7440-47-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d6d66265-7a8e-414c-af96-aeb34c3b078a/documents/IUC5-dad86a2f-2e89-401e-8451-7f6c0e7cbd12_2e5e06a1-3050-454d-a362-125fc3c00779.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,3 mg/m3,, Chromium,7440-47-3,"An acute oral toxicity test indicated an LD50 > 5000 mg/kg for chromium(III) oxide, corresponding to ca 3400 mg Cr/kg bw. LC50 for acute inhalation toxicity is >5.41 mg/L (5410 mg/m3) air (analytical). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6d66265-7a8e-414c-af96-aeb34c3b078a/documents/IUC5-f23bc3a9-2733-438a-a38f-22ea51b7d778_2e5e06a1-3050-454d-a362-125fc3c00779.html,,,,,, Chromium,7440-47-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6d66265-7a8e-414c-af96-aeb34c3b078a/documents/IUC5-f23bc3a9-2733-438a-a38f-22ea51b7d778_2e5e06a1-3050-454d-a362-125fc3c00779.html,,oral,LD50,"3,400 mg/kg bw",, Chromium,7440-47-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6d66265-7a8e-414c-af96-aeb34c3b078a/documents/IUC5-f23bc3a9-2733-438a-a38f-22ea51b7d778_2e5e06a1-3050-454d-a362-125fc3c00779.html,,inhalation,LC50,"5,410 mg/m3",, Chymotrypsin,9004-07-3," The animals at all the tested doses (1060, 1591 and 2111 mg TOS/kg body weight) did not reveal any clinical signs of toxicity throughout the observation period and no mortality occurred. The body weight and percent change in body weight of animals at all the steps increased with respect to Day 1. A complete gross pathological examination was carried out for the animals and there were no gross pathological changes observed in any of the animals. Based on the results of the experiment and under experimental conditions employed, it can be concluded that the test item Serine Endopeptidase, batch PPA 26797 cannot be classified based on the GHS criteria. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7d7864f-b414-49aa-aa7c-a0c342af5a6f/documents/979f30e3-9f16-4c3f-828c-e21bcd7575b9_7a7e155c-c036-4046-b876-bf47c5a1ffcb.html,,,,,, 2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide,2512-29-0,"Subacute oral repeated dose study: Male and female Wistar rats (20 animals per sex and dose group) received 22 daily oral (gavage) doses of 0 or 1000 mg test item per kg bw over a period of 30 days and were partially (10 animals per sex and dose group) observed for another 14 days without treatment. Cage side observations, food consumption, body weight development, haematology, clinical biochemistry, urine analysis, macroscopic investigations, organ weights and histopathology of selected organs did not reveal any substance related toxic effects. The NOAEL in this study was 1000 mg/kg bw.   Combined repeated dose and reproduction / developmental screening: This OECD 422 study is a valid investigation of the toxicological effects resulting from repeated oral-gavage administration of the test item. The test item was administered in vehicle (1.0% CMC / 0.05% Tween 80 in highly purified water) at dosages of 100, 300, and 1000 mg/kg body weight/day, animals in control groups received the vehicle only. Test item was administered to male rats for 32 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum. Under the conditions of this study, no adverse effects were found in males or females up to the highest dose level of 1000 mg/kg bw/day. Subchronic oral repeated dose study (Pigment Yellow 74): A 90-day toxicity study in Fischer F344 rats was performed with the close analogue PY 74. Groups of 10 male and 10 female rats received 0, 50, 200 and 1000 mg/kg/day by oral gavage in corn oil for 90 days. The study included additional control and high dose groups of 6 males and 6 females each analyzed after a 4-week recovery period. All animals survived until scheduled termination without any toxic signs in life. In haematology, clinical biochemistry and urinalysis some scattered significant differences, altogether without a clear dose response and all only minor in severity, were noted. Post mortem examination including histopathology did not reveal any test substance related toxic alterations. The test substance caused elevated liver weights in the high dosed females. As there were no corresponding histopathological or clinical-biochemical alterations found, the most likely interpretation is an adaptive response by enzyme induction. No parallel trend was present in the males. The effects did not persist until the end of the recovery period. No other test substance-related effect was noted. The No-observed-adverse-effect-level (NOAEL) of the test item was 1000 mg/kg bw/day in both sexes. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b264434d-a005-45b5-847b-c616cd18b246/documents/55c8a24e-8754-480b-a0dd-54cb192cdd5f_e83e7bb5-8a11-45e5-89c1-0bc1d6a54eae.html,,,,,, 2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide,2512-29-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b264434d-a005-45b5-847b-c616cd18b246/documents/55c8a24e-8754-480b-a0dd-54cb192cdd5f_e83e7bb5-8a11-45e5-89c1-0bc1d6a54eae.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide,2512-29-0,"Ten female Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage at a dose of 10000 mg/kg bw. No animal died during the 14-day observation period, resulting in a LD50 >10000 mg/kg bw. The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): reliable ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b264434d-a005-45b5-847b-c616cd18b246/documents/1f1e52ce-06fa-4214-b6c8-d3a91f110c2d_e83e7bb5-8a11-45e5-89c1-0bc1d6a54eae.html,,,,,, 2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide,2512-29-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b264434d-a005-45b5-847b-c616cd18b246/documents/1f1e52ce-06fa-4214-b6c8-d3a91f110c2d_e83e7bb5-8a11-45e5-89c1-0bc1d6a54eae.html,,oral,LD50,"> 10,000 mg/kg bw",no adverse effect observed, 2-[(4-methyl-2-nitrophenyl)azo]-3-oxo-N-phenylbutyramide,2512-29-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b264434d-a005-45b5-847b-c616cd18b246/documents/1f1e52ce-06fa-4214-b6c8-d3a91f110c2d_e83e7bb5-8a11-45e5-89c1-0bc1d6a54eae.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-[(4-chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide,6486-23-3,"A 90-day toxicity study in Fischer F344 rats was performed with a structural analogue Pigment Yellow 74. Groups of 10 male and 10 female rats received 0, 50, 200 and 1000 mg/kg/day by oral gavage in corn oil for 90 days. The study included additional control and high dose groups of 6 males and 6 females each analyzed after a 4-week recovery period. All animals survived until scheduled termination without any toxic signs in life. In haematology, clinical biochemistry and urinalysis some scattered significant differences, altogether without a clear dose response and all only minor in severity, were noted. Post mortem examination including histopathology did not reveal any test substance related toxic alterations. The test substance caused elevated liver weights in the high dosed females. As there were no corresponding histopathological or clinical-biochemical alterations found, the most likely interpretation is an adaptive response by enzyme induction. No parallel trend was present in the males. The effects did not persist until the end of the recovery period. No other test substance-related effect was noted. The No-observed-adverse-effect-level (NOAEL) of the test item was 1000 mg/kg bw/day in both sexes. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2f9b915-11ed-4850-b2ac-13ade9627ebd/documents/e2f2bb0d-b096-4fe0-aff1-4ec29b2ccf78_4345d330-c994-42ad-9f23-508058a6ff49.html,,,,,, 2-[(4-chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide,6486-23-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2f9b915-11ed-4850-b2ac-13ade9627ebd/documents/e2f2bb0d-b096-4fe0-aff1-4ec29b2ccf78_4345d330-c994-42ad-9f23-508058a6ff49.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-[(4-chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide,6486-23-3,"Acute toxicity of the registered substance has been investigated in female SPF-Wistar rats (10 animals per dose group). The animals received 4000, 6300, 10000 or 15000 mg test item / kg bw by gavage (12.5% suspension in sesame oil). The post observation period was 7 days. The mortality was 0/10, 1/10, 9/10 and 10/10 in the 4000, 6300, 10000 or 15000 mg / kg bw dose group. The LD50 was calculated to be 8252 mg/kg bw. Animals which died showed imbalance, accelerated respiration, prone position and paralysis of the limbs. No pathologic findings were observed at necropsy. The acute dermal median lethal dose (LD50) of a close structural analogue (Pigment Yellow 1) in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable with restrictions ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2f9b915-11ed-4850-b2ac-13ade9627ebd/documents/69bf6f0e-432f-41d0-84e2-fb4974baf35d_4345d330-c994-42ad-9f23-508058a6ff49.html,,,,,, 2-[(4-chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide,6486-23-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2f9b915-11ed-4850-b2ac-13ade9627ebd/documents/69bf6f0e-432f-41d0-84e2-fb4974baf35d_4345d330-c994-42ad-9f23-508058a6ff49.html,,oral,LD50,"8,252 mg/kg bw",no adverse effect observed, 2-[(4-chloro-2-nitrophenyl)azo]-N-(2-chlorophenyl)-3-oxobutyramide,6486-23-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2f9b915-11ed-4850-b2ac-13ade9627ebd/documents/69bf6f0e-432f-41d0-84e2-fb4974baf35d_4345d330-c994-42ad-9f23-508058a6ff49.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-[(2-chloro-4-nitrophenyl)azo]-2-naphthol,2814-77-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2f42598-56da-4e1c-b0e0-5815f6981b26/documents/IUC5-879e5789-87df-4af9-ab7a-3b8bcba05b59_cc76adbc-ecef-4d41-909d-b300e1b389a1.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,500 mg/kg bw/day,,rat 1-(4-methyl-2-nitrophenylazo)-2-naphthol,2425-85-6,"2- Week Studies: Groups of five rats and five mice of each Sex were given feed containing 0,6,000,12,500, 25,000, 50,000, or 100,000 ppm C.I. Pigment Red 3 for 2 weeks. No chemical-related deaths occurred in rats or mice. Final mean body weights of exposed rats and male mice were lower than controls; female mice that received 6,000 and 50,000 ppm had significantly increased final mean body weights compared to that of the controls. The feed consumption of treated rats and mice was slightly greater than that of the controls, suggesting that C.I. Pigment Red 3 had no adverse effects on the feed palatability. Dose-related decreases in erythrocyte counts and hematocrit values and an increase in reticulocyte counts were observed in rats. Changes in these Parameters were observed in mice, but there were no clear, dose-related trends.   13-Week Studies: Groups of ten rats and ten mice of each Sex were given feed containing 0, 3,000, 6,000, 12,500, 25,000, or 50,000 ppm C.I. Pigment Red 3 for 13 weeks. The dose levels selected were 0, 6000, 12500 and 25000 ppm. This resulted in calculated time weighted average daily dose levels of 272, 567, and 1219 mg/kg b.w. in males and 323, 686, and 1388 mg/kg in females at 6000, 12500 and 25000 ppm, respectively. No chemical-related deaths were observed in rats or mice. The final mean body weights of exposed female rats were significantly lower than that of the controls; the final mean body weights of exposed male rats and exposed mice were similar to controls. There were significant increases in relative liver and kidney weights of exposed male rats. Increases in the relative liver weights in mice did not occur with a dose-related trend and thus they were not considered related to chemical administration. Sites for the toxicity of C.I. Pigment Red 3 were the bone marrow, kidney, liver, and spleen in rats. Lesions observed in rats included bone marrow hyperplasia, congestion and hematopoietic cell proliferation of the spleen, and iron-positive pigmentation of the spleen, kidney, and liver. Sites for the toxicity of C.I. Pigment Red 3 in mice were the liver, kidney, and spleen in males and the liver and spleen in females. Lesions noted among mice in the spleen were hematopoietic cell proliferation and iron-positive pigmentation. In the liver, there was hematopoietic cell proliferation in male and female mice. Cytomegaly occurred in the renal tubule epithelium of the male mouse kidney. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8e96984-824e-43e9-a23e-65dba3ef52d2/documents/e7f581e9-c236-4694-8128-0757dc65b29c_b902ece3-7630-4a74-8ea8-8e778bdfeb20.html,,,,,, 1-(4-methyl-2-nitrophenylazo)-2-naphthol,2425-85-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8e96984-824e-43e9-a23e-65dba3ef52d2/documents/e7f581e9-c236-4694-8128-0757dc65b29c_b902ece3-7630-4a74-8ea8-8e778bdfeb20.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,136 mg/kg bw/day,,rat 1-(4-methyl-2-nitrophenylazo)-2-naphthol,2425-85-6,"Acute oral toxicity: Acute toxicity after single oral application was tested in male and female rats and mice, which received 10,000 mg/kg bw. No animals in these studies died. The LD50 value for acute oral toxicity is >10,000 mg/kg bw. Acute dermal toxicity: A Study was conducted with a close analogue, C.I. Pigment Orange 5, in rats. The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bw. Acute inhalation toxicity: Study was waived; substance is not classified for this endpoint. When aerosolized in respirable form, the substance is considered likely to behave like an inert dust. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8e96984-824e-43e9-a23e-65dba3ef52d2/documents/dd9978a6-87e0-4d08-86d8-56b4ef898d61_b902ece3-7630-4a74-8ea8-8e778bdfeb20.html,,,,,, 1-(4-methyl-2-nitrophenylazo)-2-naphthol,2425-85-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8e96984-824e-43e9-a23e-65dba3ef52d2/documents/dd9978a6-87e0-4d08-86d8-56b4ef898d61_b902ece3-7630-4a74-8ea8-8e778bdfeb20.html,,oral,LD50,"> 10,000 mg/kg bw",no adverse effect observed, 1-(4-methyl-2-nitrophenylazo)-2-naphthol,2425-85-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8e96984-824e-43e9-a23e-65dba3ef52d2/documents/dd9978a6-87e0-4d08-86d8-56b4ef898d61_b902ece3-7630-4a74-8ea8-8e778bdfeb20.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 1-[(2-methoxyphenyl)azo]-2-naphthol,1229-55-6, Acute oral toxicity: LD50 was considered to be > 5000 mg/kg bw when Fischer 344 male and female rats were treated Solvent Red 1 (1-[(2-methoxyphenyl)diazenyl]-2-naphthol) orally. Acute dermal toxicity: LD50 was considered to be > 2000 mg/kg bw when New Zealand White male and female rabbits were treated with Solvent Red 1 (1-[(2-methoxyphenyl)diazenyl]-2-naphthol) by dermal application for 24 hours. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2aebc0db-9b7d-4bb9-a6b6-9c44d25e7b43/documents/2a599159-cbbe-48a3-96fe-fa34620c381c_33b37f0c-3b7c-4cb8-8f92-0f698eb9c0e9.html,,,,,, 1-[(2-methoxyphenyl)azo]-2-naphthol,1229-55-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2aebc0db-9b7d-4bb9-a6b6-9c44d25e7b43/documents/2a599159-cbbe-48a3-96fe-fa34620c381c_33b37f0c-3b7c-4cb8-8f92-0f698eb9c0e9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 1-[(2-methoxyphenyl)azo]-2-naphthol,1229-55-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2aebc0db-9b7d-4bb9-a6b6-9c44d25e7b43/documents/2a599159-cbbe-48a3-96fe-fa34620c381c_33b37f0c-3b7c-4cb8-8f92-0f698eb9c0e9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide",6535-46-2,"Repeated oral toxicity: The toxicity of Pigment Red 112 when given by oral administration (gavage) to groups of 5 rats per sex per dose for 28 consecutive days at dosages of 0, 100, 300 or 1000 mg/kg bw/day, for 7 days/week have been investigated. No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). Red staining of various body parts, red faeces and reddish contents of the gastro-intestinal tract noted among all groups treated with the test substance was considered to be related to staining properties of the test substance, and not to represent a sign of toxicity. No correlating histopathological abnormalities were noted. On the basis of these results, the high dose level of 1000 mg/kg/day was considered to be the No-Observed-Adverse-Effect Level (NOAEL) for Pigment Red 112. Repeated dermal toxicity: The dermal route was waived; substance is not classified for this endpoint. The substance is considered not to exert any local or systemic adverse effects.   Repeated inhalation toxicity: The objective of the OECD TG 413 following study was to determine the toxic potential of the test item, Pigment Red 112, when administered for 6 hours/day, 5 days per week, for 13 consecutive weeks by flow-past nose-only inhalation route to Sprague Dawley rats. This study provides information on toxic effects, target organs, the possibility of cumulative effects, the reversibility of effects (after 90 and 180 days recovery period), and an estimate of the No Observed Adverse Effects Concentration (NOAEC). Based on the observed results, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item was found to be 30 mg/m³ (0,03 mg/L) after 90 days of exposure (highest concentration tested). The nominal dose of 0.03 mg/L (6 hrs/day, 5 days/week) corresponded to an actual exposure concentration in males and females. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/628ebd00-f1a6-4de6-8ed7-c80117e763d2/documents/cd48e5da-2268-4877-8ae3-29eece5057d8_526695d0-befa-42fc-90cf-cc291bb375c3.html,,,,,, "3-hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide",6535-46-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/628ebd00-f1a6-4de6-8ed7-c80117e763d2/documents/cd48e5da-2268-4877-8ae3-29eece5057d8_526695d0-befa-42fc-90cf-cc291bb375c3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3-hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide",6535-46-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/628ebd00-f1a6-4de6-8ed7-c80117e763d2/documents/cd48e5da-2268-4877-8ae3-29eece5057d8_526695d0-befa-42fc-90cf-cc291bb375c3.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat "3-hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide",6535-46-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/628ebd00-f1a6-4de6-8ed7-c80117e763d2/documents/cd48e5da-2268-4877-8ae3-29eece5057d8_526695d0-befa-42fc-90cf-cc291bb375c3.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat "3-hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide",6535-46-2,"Acute oral toxicity: The test item (Pigment Red 112) did not cause any mortality or significant clinical signs or necropsy findings after single oral gavage administration to male and female rats at 5000 mg/kg bw in an OECD guideline and GLP compliant study. Therefore, the LD50 (male/female rat) was greater than 5000 mg/kg body weight (Hoechst, 1983). This key study is supported by further acute oral toxicity studies with Pigment Red 112 in which no lethal or other severe effects were reported at the highest dose tested of 10,000 mg/kg (Hoechst, 1979a; 1979b). Acute dermal toxicity: The test item (preparation containing Pigment Red 112 at >90%) did not cause any mortality or significant clinical signs or necropsy findings after single dermal application to male rats at 5000 mg/kg bw in an OECD guideline compliant study. The LD50 (male rat) was greater than 5000 mg/kg body weight. Acute inhalation toxicity: The mean median Lethal Concentration (LC50) of a close analogue Pigment Red 188 is more than 5.05 mg/L air in Wistar rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/628ebd00-f1a6-4de6-8ed7-c80117e763d2/documents/faf21ad3-c673-4395-82f6-8c57d1fb5de6_526695d0-befa-42fc-90cf-cc291bb375c3.html,,,,,, "3-hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide",6535-46-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/628ebd00-f1a6-4de6-8ed7-c80117e763d2/documents/faf21ad3-c673-4395-82f6-8c57d1fb5de6_526695d0-befa-42fc-90cf-cc291bb375c3.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "3-hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide",6535-46-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/628ebd00-f1a6-4de6-8ed7-c80117e763d2/documents/faf21ad3-c673-4395-82f6-8c57d1fb5de6_526695d0-befa-42fc-90cf-cc291bb375c3.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "3-hydroxy-N-(o-tolyl)-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide",6535-46-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/628ebd00-f1a6-4de6-8ed7-c80117e763d2/documents/faf21ad3-c673-4395-82f6-8c57d1fb5de6_526695d0-befa-42fc-90cf-cc291bb375c3.html,,inhalation,LC50,> 5.05 mg/L,no adverse effect observed, "N-(5-chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide",6410-41-9,"oral route: Pigment Red 112 The toxicity of the test item when given by oral administration (gavage) to groups of 5 rats per sex per dose for 28 consecutive days at dosages of 0, 100, 300 or 1000 mg/kg bw/day, for 7 days/week have been investigated. No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). Red staining of various body parts, red faeces and reddish contents of the gastro-intestinal tract noted among all groups treated with the test substance was considered to be related to staining properties of the test substance, and not to represent signs of systemic toxicity. No correlating histopathological abnormalities were noted. On the basis of these results, the high dose level of 1000 mg/kg/day was considered to be the No Observed Adverse Effect Level (NOAEL) for the test substance. Pigment Red 22 A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test was performed according to OECD TG 422. The test item was administered to Sprague Dawley rats (12/sex/dose) by gavage at dose levels of 0, 100, 300 and 1000 mg/kg/day for a total of 37 days (males) and through mating, gestation and delivery until day 4 of lactation (females). No toxic effects were observed in this study except increased liver weights in males and females of the highest dose group. As the effects on liver weight were minimal (less than 10% weight changes) and not accompanied by any histopathological or biochemical changes these effects were judged not to be adverse. The no-observed-adverse-effect level (NOAEL) for repeated dose toxicity was 1000 mg/kg under the conditions of this study. There were no effects on reproduction or development. inhalation route: Pigment Red 112 The objective of the OECD TG 413 following study was to determine the toxic potential of the close analogue, Pigment Red 112, when administered for 6 hours/day, 5 days per week, for 13 consecutive weeks by flow-past nose-only inhalation route to Sprague Dawley rats. This study provides information on toxic effects, target organs, the possibility of cumulative effects, the reversibility of effects (after 90 and 180 days recovery period), and an estimate of the No Observed Adverse Effects Concentration (NOAEC). Based on the observed results, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item was found to be 30 mg/m³ (0,03 mg/L) after 90 days of exposure (highest concentration tested). The nominal dose of 0.03 mg/L (6 hrs/day, 5 days/week) corresponded to an actual exposure concentration in males and females. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf9e03ee-4212-4232-8680-c1ecd3263149/documents/48e124bc-116d-4c72-abd4-c40de718a072_93a00287-a357-43c5-a395-e3367876432d.html,,,,,, "N-(5-chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide",6410-41-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf9e03ee-4212-4232-8680-c1ecd3263149/documents/48e124bc-116d-4c72-abd4-c40de718a072_93a00287-a357-43c5-a395-e3367876432d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N-(5-chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide",6410-41-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf9e03ee-4212-4232-8680-c1ecd3263149/documents/48e124bc-116d-4c72-abd4-c40de718a072_93a00287-a357-43c5-a395-e3367876432d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,>= 30 mg/m3,,rat "N-(5-chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide",6410-41-9,Acute oral toxicity: A close structural analogue substance (Pigment Red 112) did not cause any mortality or significant clinical signs or necropsy findings after single oral gavage administration to male and female rats at 5000 mg/kg bw in an OECD guideline and GLP compliant study. The LD50 (male/female rat) was greater than 5000 mg/kg body weight.   Acute dermal toxicity: A close structural analogue substance (<90% Pigment Red 112) did not cause any mortality or significant clinical signs or necropsy findings after single dermal application to male rats at 5000 mg/kg bw in a OECD guideline compliant study. The LD50 (male rat) was greater than 5000 mg/kg body weight.   Acute inhalation toxicity: The mean median Lethal Concentration (LC50) of a close analogue Pigment Red 188 is more than 5.05 mg/L air in an OECD and GLP compliant acute inhalation toxicity study in Wistar rats. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf9e03ee-4212-4232-8680-c1ecd3263149/documents/64e8a630-f7b2-4283-95ff-8f0d9603a542_93a00287-a357-43c5-a395-e3367876432d.html,,,,,, "N-(5-chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide",6410-41-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf9e03ee-4212-4232-8680-c1ecd3263149/documents/64e8a630-f7b2-4283-95ff-8f0d9603a542_93a00287-a357-43c5-a395-e3367876432d.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "N-(5-chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide",6410-41-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf9e03ee-4212-4232-8680-c1ecd3263149/documents/64e8a630-f7b2-4283-95ff-8f0d9603a542_93a00287-a357-43c5-a395-e3367876432d.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "N-(5-chloro-2,4-dimethoxyphenyl)-4-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide",6410-41-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf9e03ee-4212-4232-8680-c1ecd3263149/documents/64e8a630-f7b2-4283-95ff-8f0d9603a542_93a00287-a357-43c5-a395-e3367876432d.html,,inhalation,LC50,"> 5,050 mg/m3",no adverse effect observed, "2,4-dihydro-5-methyl-2-phenyl-4-(phenylazo)-3H-pyrazol-3-one",4314-14-1,In an oral acute study no mortality was recorded at a dose of 15000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4f9cab8-ad90-4ecc-b22a-ffc4f8b9368c/documents/IUC5-940af9a1-20a2-4368-abff-ffe8f189b97b_0323e622-e561-4a26-a10a-aee92c23f50e.html,,,,,, Disodium 2-amino-5-[(4-sulphonatophenyl)azo]benzenesulphonate,2706-28-7, The test chemical Fast Yelow Ab is not likely to classify as a toxicant upon repeated exposure by oral route. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66d60228-5408-4a05-91a0-06108bda5253/documents/IUC5-9fc56433-68c4-42a0-a965-058603facd9b_4cef51f2-8821-47e5-be47-f09687bc056a.html,,,,,, Disodium 2-amino-5-[(4-sulphonatophenyl)azo]benzenesulphonate,2706-28-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66d60228-5408-4a05-91a0-06108bda5253/documents/IUC5-9fc56433-68c4-42a0-a965-058603facd9b_4cef51f2-8821-47e5-be47-f09687bc056a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,500 mg/kg bw/day",,pig Disodium 2-amino-5-[(4-sulphonatophenyl)azo]benzenesulphonate,2706-28-7, acid yellow 9 was non toxic by oral route in rat. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66d60228-5408-4a05-91a0-06108bda5253/documents/IUC5-3adab316-b6fb-4b22-8f59-5e7c867ed1ff_4cef51f2-8821-47e5-be47-f09687bc056a.html,,,,,, Disodium 2-amino-5-[(4-sulphonatophenyl)azo]benzenesulphonate,2706-28-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66d60228-5408-4a05-91a0-06108bda5253/documents/IUC5-3adab316-b6fb-4b22-8f59-5e7c867ed1ff_4cef51f2-8821-47e5-be47-f09687bc056a.html,,oral,LD50,"4,813.4 mg/kg bw",no adverse effect observed, "Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate",4548-53-2,The acute oral LD50 value of substance FD&C Red No. 4 is considered to be >2000 mg/kg in rat. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fca3091a-dcf3-4a3b-87c4-7f3ff6bbb698/documents/IUC5-50e46e5b-f132-4b4f-9f05-e6fc3c3ddcbd_9b9726a2-eaaa-42f8-b946-b6d7e02612b6.html,,,,,, "Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate",4548-53-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fca3091a-dcf3-4a3b-87c4-7f3ff6bbb698/documents/IUC5-50e46e5b-f132-4b4f-9f05-e6fc3c3ddcbd_9b9726a2-eaaa-42f8-b946-b6d7e02612b6.html,,oral,LD50,"4,952.15 mg/kg bw",no adverse effect observed, Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate,3567-69-9," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalene sulphonate (CAS No. 3567-69-9) cannot be classified for acute oral toxicity.     Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalene sulphonate (CAS No. 3567-69-9) cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6187da5-0dec-41bc-b04c-ff126715638e/documents/c3bdfab5-c1ec-4757-b62c-1bbdafaf026b_33704e19-2936-4dbe-9dfd-f277b43391fc.html,,,,,, Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate,3567-69-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6187da5-0dec-41bc-b04c-ff126715638e/documents/c3bdfab5-c1ec-4757-b62c-1bbdafaf026b_33704e19-2936-4dbe-9dfd-f277b43391fc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Disodium 4-hydroxy-3-[(4-sulphonatonaphthyl)azo]naphthalenesulphonate,3567-69-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6187da5-0dec-41bc-b04c-ff126715638e/documents/c3bdfab5-c1ec-4757-b62c-1bbdafaf026b_33704e19-2936-4dbe-9dfd-f277b43391fc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 4(-2-hydroxy-1-naphthylazo)naphthalenesulphonate,1658-56-6," LD50 (oral, rat) > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b84ad172-1640-4da1-9d2b-481240e83056/documents/836715a3-3950-4639-8395-c12ff56e4b87_88d6094c-bea7-4641-bdeb-699189a696e0.html,,,,,, Sodium 4(-2-hydroxy-1-naphthylazo)naphthalenesulphonate,1658-56-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b84ad172-1640-4da1-9d2b-481240e83056/documents/836715a3-3950-4639-8395-c12ff56e4b87_88d6094c-bea7-4641-bdeb-699189a696e0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Manganese, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex",5280-66-0," The NOAEL for chronic oral toxicity is established at 25 mg/kg bw based on repeated dose toxicity studies with analogue substances. Higher doses result in kidney damage. This is derived from subacute gavage studies with Pigment Red 57:1(Ca) (OECD 422, GLP, MHLW 1993), Pigment Red 48:2(Ca) (OECD 422, GLP, MHLW 2009) and Pigment Red 57(Sr) (OECD 407, GLP, DIC 2006). No histopathology findings on kidneys were reported after a two-year skin painting study with mice with Pigment Red 57:1(Ca) (Carson 1984). Regarding the cation, available data indicate that the limit values derived by the SCOEL are lower than those calculated for the kidney effects of the organic part and will therefore be used for protection to the pigment. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25ee23d0-bccf-4e65-b361-c56fcb17209d/documents/IUC5-5f298a67-6736-47b3-8804-7f18f39f72e5_38872696-dbf9-45b6-88cd-2a12cc865da1.html,,,,,, "Manganese, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex",5280-66-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25ee23d0-bccf-4e65-b361-c56fcb17209d/documents/IUC5-5f298a67-6736-47b3-8804-7f18f39f72e5_38872696-dbf9-45b6-88cd-2a12cc865da1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat "Manganese, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex",5280-66-0," Studies of Pigment Red 48:3 and of other members of the same category indicate that Pigment Red 48:4 is not acutely toxic via the oral, inhalation, and dermal route of exposure. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25ee23d0-bccf-4e65-b361-c56fcb17209d/documents/IUC5-241994e9-5dee-41e3-9845-355b95564f35_38872696-dbf9-45b6-88cd-2a12cc865da1.html,,,,,, "Manganese, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex",5280-66-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25ee23d0-bccf-4e65-b361-c56fcb17209d/documents/IUC5-241994e9-5dee-41e3-9845-355b95564f35_38872696-dbf9-45b6-88cd-2a12cc865da1.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "Manganese, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex",5280-66-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25ee23d0-bccf-4e65-b361-c56fcb17209d/documents/IUC5-241994e9-5dee-41e3-9845-355b95564f35_38872696-dbf9-45b6-88cd-2a12cc865da1.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "Manganese, 4-[(5-chloro-4-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex",5280-66-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25ee23d0-bccf-4e65-b361-c56fcb17209d/documents/IUC5-241994e9-5dee-41e3-9845-355b95564f35_38872696-dbf9-45b6-88cd-2a12cc865da1.html,,inhalation,LC50,"1,518 mg/m3",no adverse effect observed, Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate,6417-83-0," A chronic feeding study performed with a substance analogue in rats is available (Klimisch 2). Based on the results, the NOAEL for males was found to be 0.3% in feed (corresponding to appr. 161 mg/kg bw/day). For females, the NOAEL was found to be 2.0% in feed (corresponding to 1315 mg/kg bw/day). This result is read across to the registered ubstance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1dd27c9-d32d-4273-999f-3c333a756e6e/documents/9bf04b69-dba2-490b-994c-71c556913971_ad5303f6-7840-4efb-be67-4ad15b805c23.html,,,,,, Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate,6417-83-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1dd27c9-d32d-4273-999f-3c333a756e6e/documents/9bf04b69-dba2-490b-994c-71c556913971_ad5303f6-7840-4efb-be67-4ad15b805c23.html,Chronic toxicity – systemic effects,oral,NOAEL,161 mg/kg bw/day,,rat Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate,6417-83-0," Two acute oral toxicity studies in rats were performed, both resulting in LD50 values of >5000 mg/kg bw. An acute inhalation study was performed, the results show that PR63:1 is not acutely toxic after inhalation (LC50 > 5 mg/L). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1dd27c9-d32d-4273-999f-3c333a756e6e/documents/IUC5-fa6decce-2e69-45a7-8050-58b0727ce24c_ad5303f6-7840-4efb-be67-4ad15b805c23.html,,,,,, Calcium 3-hydroxy-4-[(1-sulphonato-2-naphthyl)azo]-2-naphthoate,6417-83-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1dd27c9-d32d-4273-999f-3c333a756e6e/documents/IUC5-fa6decce-2e69-45a7-8050-58b0727ce24c_ad5303f6-7840-4efb-be67-4ad15b805c23.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate,2783-94-0,"The substance disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate does not exhibit repeated dose toxicity by the oral,inhalation and dermal route. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/551f2a09-a201-406f-8455-86179d437c55/documents/IUC5-1005a4aa-6867-40f5-8c61-a8e7b9ce20dd_6e653bdf-f567-42b0-aa73-f43116372a86.html,,,,,, Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate,2783-94-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/551f2a09-a201-406f-8455-86179d437c55/documents/IUC5-1005a4aa-6867-40f5-8c61-a8e7b9ce20dd_6e653bdf-f567-42b0-aa73-f43116372a86.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"10,000 mg/kg bw/day",,rabbit Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate,2783-94-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/551f2a09-a201-406f-8455-86179d437c55/documents/IUC5-1005a4aa-6867-40f5-8c61-a8e7b9ce20dd_6e653bdf-f567-42b0-aa73-f43116372a86.html,Chronic toxicity – systemic effects,oral,NOAEL,"16,000 mg/kg bw/day",,mouse Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate,2783-94-0," Acute toxicity:oral route: Under the condition of the study, the acute oral LD50 (Cut-off value) of Neelicol Sunset Yellow FCF   (CAS No. 2783-94-0) was >2000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of Neelicol Sunset Yellow FCF   (CAS No. 2783-94-0), when administered via oral route in Wistar rats. Acute toxicity:Dermal Route: It was concluded that the acute dermal median lethal dose (LD50) of NEELICOL SUNSET YELLOW FCF (CAS No. 2783-94-0), when administered to female Wistar rats was considered to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical NEELICOL SUNSET YELLOW FCF  (CAS No. 2783-94-0) does not classify as an acute dermal toxicant. CLP Classification: “Not classified”. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/551f2a09-a201-406f-8455-86179d437c55/documents/IUC5-9b477254-28d6-4bb8-8226-204d04240fff_6e653bdf-f567-42b0-aa73-f43116372a86.html,,,,,, Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate,2783-94-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/551f2a09-a201-406f-8455-86179d437c55/documents/IUC5-9b477254-28d6-4bb8-8226-204d04240fff_6e653bdf-f567-42b0-aa73-f43116372a86.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate,25956-17-6," Repeated Dose Toxicity study : Oral: The No Observed Adverse Effect Level (NOAEL) of the test chemical in the rat via oral route of exposure is considered to be 7300 mg/kg body weight in male and 8300 mg/kg body weight in female animals. Repeated dose Inhalation toxicity The short term inhalation study need not be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the thorough and rigorous exposure. The estimated vapour pressure of test chemical at 25 deg C was observed to be at 1.67E-021 Pa. Hence, this endpoint was considered for waiver.   Repeated dose Dermal toxicity The short term inhalation study need not be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the thorough and rigorous exposure.The acute dermal LD50 of the test chemical can be considered to be >2000 mg/kgbw. Hence, this endpoint was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d67965b-fc22-49a9-ac18-9f2a0901e4c3/documents/1d69a32c-b63d-4f6b-8b21-c05866412a28_4b8a7c54-3344-44f0-956b-5ebdaa7ff5e9.html,,,,,, Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate,25956-17-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d67965b-fc22-49a9-ac18-9f2a0901e4c3/documents/1d69a32c-b63d-4f6b-8b21-c05866412a28_4b8a7c54-3344-44f0-956b-5ebdaa7ff5e9.html,Chronic toxicity – systemic effects,oral,NOAEL,"7,300 mg/kg bw/day",,mouse Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate,25956-17-6," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the given test chemical. The LD50 value is >10000 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 1.67E-021 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The LD50 value is >10000 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d67965b-fc22-49a9-ac18-9f2a0901e4c3/documents/88cc59aa-f4a3-4d48-aea8-590c28df6cef_4b8a7c54-3344-44f0-956b-5ebdaa7ff5e9.html,,,,,, Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate,25956-17-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d67965b-fc22-49a9-ac18-9f2a0901e4c3/documents/88cc59aa-f4a3-4d48-aea8-590c28df6cef_4b8a7c54-3344-44f0-956b-5ebdaa7ff5e9.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Disodium 6-hydroxy-5-[(2-methoxy-4-sulphonato-m-tolyl)azo]naphthalene-2-sulphonate,25956-17-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d67965b-fc22-49a9-ac18-9f2a0901e4c3/documents/88cc59aa-f4a3-4d48-aea8-590c28df6cef_4b8a7c54-3344-44f0-956b-5ebdaa7ff5e9.html,,dermal,LD50,"10,000 mg/kg bw",no adverse effect observed, "Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate",3734-67-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2449649a-6004-4a7b-9984-4a9713100949/documents/IUC5-55a62cf4-46e9-402e-a65f-1b3e60bd8c5a_9556555a-7883-4956-a903-581eee090a59.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrogen bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",5601-29-6," Acute toxicity, oral: LD50 = 8290 mg/kg bw Acute toxicity, dermal: LD50 > 5000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/144a2662-4d56-4f2b-94a3-acff305ef2af/documents/IUC5-96c10646-4bbb-418e-b6ad-77c29573be70_975bd23c-9441-41f8-948c-fdf24f3c3276.html,,,,,, "Hydrogen bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",5601-29-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/144a2662-4d56-4f2b-94a3-acff305ef2af/documents/IUC5-96c10646-4bbb-418e-b6ad-77c29573be70_975bd23c-9441-41f8-948c-fdf24f3c3276.html,,oral,LD50,"8,290 mg/kg bw",no adverse effect observed, "Hydrogen bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",5601-29-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/144a2662-4d56-4f2b-94a3-acff305ef2af/documents/IUC5-96c10646-4bbb-418e-b6ad-77c29573be70_975bd23c-9441-41f8-948c-fdf24f3c3276.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Disodium 2,5-dichloro-4-(5-hydroxy-3-methyl-4-(sulphophenylazo)pyrazol-1-yl)benzenesulphonate",6359-98-4,"- Oral: NOAEL was ≥ 2.22 and ≥ 4.45 mg/kg bw/day for male and female beagle dogs, respectively (WoE) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9ef57e2-de50-41f8-945c-8c5152ab86d8/documents/0acfcc9f-d4f0-4d4a-ae94-073e39ec6250_38c95875-80bb-482f-bbad-ab437cdd185a.html,,,,,, "Disodium 2,5-dichloro-4-(5-hydroxy-3-methyl-4-(sulphophenylazo)pyrazol-1-yl)benzenesulphonate",6359-98-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9ef57e2-de50-41f8-945c-8c5152ab86d8/documents/0acfcc9f-d4f0-4d4a-ae94-073e39ec6250_38c95875-80bb-482f-bbad-ab437cdd185a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,> 2.22 mg/kg bw/day,,dog "Disodium 2,5-dichloro-4-(5-hydroxy-3-methyl-4-(sulphophenylazo)pyrazol-1-yl)benzenesulphonate",6359-98-4,"- Acute oral toxicity: LD50 > 5000 mg/kg bw, males/females, rat, OECD TG 401-like, 1971.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9ef57e2-de50-41f8-945c-8c5152ab86d8/documents/b4706357-c254-4b67-b708-eb2a2c4a40f2_38c95875-80bb-482f-bbad-ab437cdd185a.html,,,,,, "Disodium 2,5-dichloro-4-(5-hydroxy-3-methyl-4-(sulphophenylazo)pyrazol-1-yl)benzenesulphonate",6359-98-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9ef57e2-de50-41f8-945c-8c5152ab86d8/documents/b4706357-c254-4b67-b708-eb2a2c4a40f2_38c95875-80bb-482f-bbad-ab437cdd185a.html,,oral,discriminating dose,"> 5,000 mg/kg bw",no adverse effect observed, "Sodium 4-amino-5-hydroxy-3-(4-nitrophenylazo)-6-(phenylazo)naphthalene-2,7-disulphonate",1064-48-8, Acute oral toxicity: LD50 = 5000 mg/kg body weight ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc9189f4-3106-40bc-be2a-3fff5a99130e/documents/IUC5-d072c3eb-4325-4eb8-8791-2ea4f86cd2be_5a0597a4-1094-4ce1-bcc7-da9c43f86d15.html,,,,,, "Sodium 4-amino-5-hydroxy-3-(4-nitrophenylazo)-6-(phenylazo)naphthalene-2,7-disulphonate",1064-48-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc9189f4-3106-40bc-be2a-3fff5a99130e/documents/IUC5-d072c3eb-4325-4eb8-8791-2ea4f86cd2be_5a0597a4-1094-4ce1-bcc7-da9c43f86d15.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]",5102-83-0,"Subacute toxicity of the test item was investigated in an 21 days aerosol inhalation study in rats, which were exposed to 0, 52, 151, 401 mg/m³ test item (6 h/d, 5 d/w). A slight but significant (p < 0.01) decrease in the bodyweight of the male rats an the highest concentration at termination of the exposure period was observed when compared with those of the controls and the other treated animals. A slight change was found to occur in the differential leucocyte count of male and female rats at the highest exposure level, where a higher percentage of polymorphonuclear neutrophils and a lower percentage of lymphocytes was observed. This change persisted upon cessation of treatment. The lungs of all rats from the highest concentration group were slightly enlarged and yellowish in colour. The yellowish dis­coloration of the lungs was also noted in rats from the group which was sacrificed after an additional recovery period of 21 days. The lung weights, the lung to bodyweight and lung to brain weight ratios of these animals were significantly increased. The weight increase persisted in rats of this group after anadditional recovery period of 21 days. Upon histopathological examination the lungs of all rats from the highest concentration group showed focal accumulation of slightly basophilic material and of numerous foamy cells in the alveoli. In frozen sections large amount of minute yellow-brownforeign particles (1 - 3 µm) in the lumen of the alveoli, in the cytoplasm of some foamy cells, in the lumen of occasional small bronchi and in the macrophages in the interstitium were observed. There was also slight focal lymphohistiocytic infiltration in the interstitium. Focal pneumoconiosis showing brown-yellow foreign particles (dissolved by the procedure used for tissue embedding) was also observed in the treated rats from the top concentration level after the withdrawal period of 3 weeks. Small accumulation of brown-yellow particles was occasionally found in the intra­pulmonal lymphoid tissue of these animals. In the rats treated with the intermediate concentration level the lungs showed at autopsy slight yellowish discoloration. Histo­pathology revealed brown-yellow, fat soluble particles in the alveoli and in the interstitium of the lungs. In 8 out of 20 rats from this group focal accumulation of foamy cells in several alveoli was observed as well. The yellowish discoloration of the lungs was not observed in rats from the lowest concentration group. Neither accumulation of foamy cells in the alveoli, nor interstitial inflammatory infiltration was seen upon histopathology in these animals. Minute brown­yellow fat soluble foreign particles were however found in frozen sections in the interstitium of the lungs and in occasional alveoli. No other gross or microscopical changes which could be related to the inhalation of the test item were found in the treated animals. It can be inferred from the observations made during the above study that the ""no observable effect level"" for rats is below 52 mg/m³ of air. The effects observed at the lowest test concentration were only due to the deposition of the test material but did not cause adverse effects like inflammation etc. Therefore, the lowest test concentration can be regarded as ""no observable adverse effect level"". Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliabe with restriction ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e6d5070-769c-42e1-b5b0-2c2cddc544c2/documents/ec490e67-21d8-4d91-88a6-6bfb2e385fb5_de2ef510-c9f5-4642-87fa-d4bd6ec653a0.html,,,,,, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]",5102-83-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e6d5070-769c-42e1-b5b0-2c2cddc544c2/documents/ec490e67-21d8-4d91-88a6-6bfb2e385fb5_de2ef510-c9f5-4642-87fa-d4bd6ec653a0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]",5102-83-0,"Single application of 15000 mg test substance per kg bw did not cause lethality in female Wistar-rats during the 14 day observation period, resulting in a LD50 > 15000 mg/kg bw. Exposure of male and female rats to 4250 mg/m³ test item for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 4250 mg/m³. The test item was not toxic to male and female Sprague-Dawley rats after dermal application, resulting in a dermal LD50 > 3000 mg/kg bw (corresponding to > 1710 mg PY13/kg bw). The test was performed with the test item which contains relevant amounts of the submission substance. Therefore, the test results are considered adequate to fulfil the endpoint requirements. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): reliable with restriction ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e6d5070-769c-42e1-b5b0-2c2cddc544c2/documents/ddfbbe4f-4b50-440c-96d1-7cd03d29a1c9_de2ef510-c9f5-4642-87fa-d4bd6ec653a0.html,,,,,, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]",5102-83-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e6d5070-769c-42e1-b5b0-2c2cddc544c2/documents/ddfbbe4f-4b50-440c-96d1-7cd03d29a1c9_de2ef510-c9f5-4642-87fa-d4bd6ec653a0.html,,oral,LD0,"> 15,000 mg/kg bw",no adverse effect observed, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]",5102-83-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e6d5070-769c-42e1-b5b0-2c2cddc544c2/documents/ddfbbe4f-4b50-440c-96d1-7cd03d29a1c9_de2ef510-c9f5-4642-87fa-d4bd6ec653a0.html,,dermal,LD0,"> 1,710 mg/kg bw",no adverse effect observed, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2,4-dimethylphenyl)-3-oxobutyramide]",5102-83-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e6d5070-769c-42e1-b5b0-2c2cddc544c2/documents/ddfbbe4f-4b50-440c-96d1-7cd03d29a1c9_de2ef510-c9f5-4642-87fa-d4bd6ec653a0.html,,inhalation,LC0,"> 4,250 mg/m3",no adverse effect observed, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutyramide]",5567-15-7," No toxic effects were observed in an oral repeated dose toxicity study in rats (highest dose tested: 523 mg/kg bw/day). The only effect observable after subacute inhalation exposure was minimal deposition of test material in the lung, which was accompanied by minmal, fully reversible macrophage reaction (BALF). The systemic NOAECs in these studies were 30 mg/m³. No data on chronic repeated dose toxicity after inhalation or dermal exposure are available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4c0906a-a7c1-4d80-94ec-26bd9e8a701e/documents/d1b2493e-c0a1-4d4c-8efd-e288d6ef6eb6_45fe0409-43d9-4541-8fa2-3e1e4d94f345.html,,,,,, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutyramide]",5567-15-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4c0906a-a7c1-4d80-94ec-26bd9e8a701e/documents/d1b2493e-c0a1-4d4c-8efd-e288d6ef6eb6_45fe0409-43d9-4541-8fa2-3e1e4d94f345.html,Chronic toxicity – systemic effects,oral,NOAEL,523 mg/kg bw/day,,rat "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutyramide]",5567-15-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4c0906a-a7c1-4d80-94ec-26bd9e8a701e/documents/d1b2493e-c0a1-4d4c-8efd-e288d6ef6eb6_45fe0409-43d9-4541-8fa2-3e1e4d94f345.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutyramide]",5567-15-7," Oral LD50 values for Pigment Yellow 83 are > 2000 mg/kg bw, the limit for classification (LD50 (key study) > 15,000 mg/kg bw). No lethality was observed after acute inhalation exposure to the maximum technically feasible test concentration of 4.4 mg/L Pigment Yellow 13 (strucutral analogue) and 0.23 mg/L Pigment Yellow 17 (strucutral analogue). No lethality was observed after single dermal application of 1710 mg/kg bw Pigment Yellow 13 (strucutral analogue). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4c0906a-a7c1-4d80-94ec-26bd9e8a701e/documents/903a3600-03a3-41a6-80c4-c29223ea5084_45fe0409-43d9-4541-8fa2-3e1e4d94f345.html,,,,,, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutyramide]",5567-15-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4c0906a-a7c1-4d80-94ec-26bd9e8a701e/documents/903a3600-03a3-41a6-80c4-c29223ea5084_45fe0409-43d9-4541-8fa2-3e1e4d94f345.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutyramide]",5567-15-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4c0906a-a7c1-4d80-94ec-26bd9e8a701e/documents/903a3600-03a3-41a6-80c4-c29223ea5084_45fe0409-43d9-4541-8fa2-3e1e4d94f345.html,,dermal,LD50,"1,710 mg/kg bw",no adverse effect observed, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(4-chloro-2,5-dimethoxyphenyl)-3-oxobutyramide]",5567-15-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4c0906a-a7c1-4d80-94ec-26bd9e8a701e/documents/903a3600-03a3-41a6-80c4-c29223ea5084_45fe0409-43d9-4541-8fa2-3e1e4d94f345.html,,inhalation,LC50,"4,250 mg/m3",no adverse effect observed, "Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate",2519-30-4,"I.F. Gaunt, Madge Farmer, P. Grasso, S.D. Gangolli (1967) was performed on male and female ICI Alderley Park Strain 1 SPF mouse. At concentration of 2000 mg/kg and observed for 14 days. 10 mice/sex were used. The LD50values with 95 % confidence limits were calculated according to Litchfield & Wilcoxon. No toxic signs or deaths were observed during study. Therefore, the LD 50 value of Brilliant Black PN was found to be >2000 mg/kg for mice. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a22f37b-397f-4197-9d6b-668e46b280de/documents/IUC5-83ae7d09-6377-4045-a268-61f52b9c07f9_5e7634ff-39b0-403e-a764-4db60f1f47af.html,,,,,, "Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate",2519-30-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a22f37b-397f-4197-9d6b-668e46b280de/documents/IUC5-83ae7d09-6377-4045-a268-61f52b9c07f9_5e7634ff-39b0-403e-a764-4db60f1f47af.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid, sodium salts",1325-54-8,"Following the indications of column 2 of REACH Annex VIII, the most appropiate route for testing chosen has been oral route. An OECD 422 study has been selected to be performed and has allowed to determine a NOAEL which has been used to do the Chemical Safety Assessment and derive the DNELs for each route.For dermal, based on exposure considerations and the available toxicological information, testing in a 28-days by oral route has been considered sufficient.For inhalation, the study does not need to be conducted because the exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31d34413-0fe9-4ecb-919b-2f646954a5cf/documents/IUC5-344ef7c8-63f4-4f73-a6d6-d0fe88e387b3_1c81c993-c635-4b69-a9a0-5180aff9c449.html,,,,,, "Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid, sodium salts",1325-54-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31d34413-0fe9-4ecb-919b-2f646954a5cf/documents/IUC5-344ef7c8-63f4-4f73-a6d6-d0fe88e387b3_1c81c993-c635-4b69-a9a0-5180aff9c449.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid, sodium salts",1325-54-8,The acute toxicity of the substance has been determined in adequate studies in the rat following oral administration and in the rat and rabbit with dermal administrations. No studies are available for inhalation. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31d34413-0fe9-4ecb-919b-2f646954a5cf/documents/IUC5-0f308b18-2cbe-4247-a033-9df22380a4d3_1c81c993-c635-4b69-a9a0-5180aff9c449.html,,,,,, "Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid, sodium salts",1325-54-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31d34413-0fe9-4ecb-919b-2f646954a5cf/documents/IUC5-0f308b18-2cbe-4247-a033-9df22380a4d3_1c81c993-c635-4b69-a9a0-5180aff9c449.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid, sodium salts",1325-54-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31d34413-0fe9-4ecb-919b-2f646954a5cf/documents/IUC5-0f308b18-2cbe-4247-a033-9df22380a4d3_1c81c993-c635-4b69-a9a0-5180aff9c449.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-aminophenyl)azo]benzenesulfonic acid monosodium salt",50814-31-8,"OECD 401, oral, rat, limIt dose LD50 > 2000 mg/kg. Oral,rat fed with different doses, limit dose LD50 = 8700 mg/kg. EU Method B.1, oral, rat, limit dose LD50 > 2000 mg/kg   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2941f3a-6046-47a5-b885-cb9347740d1e/documents/cfa9fd3d-dce5-459d-8b39-913792f476a3_157a4743-a736-4536-8fa0-abf083b6f82e.html,,,,,, "Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt",2353-45-9,"Repeated Dose toxicity (Oral)The summaries of the various studies presented as weight of evidence having Klimisch rating 2 are presented in the table below:S. No End pointValue (mg/kg bw)SpeciesKlimisch Rating1.NOAEL7142.85Mouse22.NOAEL500Dog23.NOAEL2500Rat24.NOAEL2857Mouse2Thus, it can be seen that the no observed adverse effect level (NOAEL) values in the various chronic studies ranges from 500 to 7142.85 mg/kg bw in various animal species tested. Hence, it can be concluded that the chemical dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt (Synonym Fast Green FCF/ FD&C Green No. 3) is not likely to exhibit toxic effects, within the dose levels mentioned upon chronic repeated dosing by the oral route.Repeated Dose (Dermal)In a Chronic dermal toxicy Study, Swiss Webster male and female mice treated with F D & C Green No. 3, the concentration of 0 and 1.0 % twice weekly. The results shows that F D & C Green NO. 3.was not toxic dermally. No effect was observed on survival and clinical signs of treated mice. High or low body weights observed late in treated group were due to only a few surviving animals which reduced the biological significance of the averages. In addition, No significant incidence of gross changes was observed in treated mice. Malignant lymphoma of liver, Kidneys and Lungs, Myeloid metaplasia of Spleen were observed in treated mice. There was no indication of treatment related changes since most lesions were also evident in the control.  Therefore, NOAEL was considered to be 1.0 % (1428.5 mg/kg) when Swiss Webster male and female mice were treated with FD & C Green NO. 3.by dermal application for 19.5 months. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3612cdf9-2e31-4a43-8034-ad3429898cc1/documents/IUC5-15948a5f-c039-4267-a361-703c2f4d3dac_a2c0876f-f6cd-48b9-bc0e-c75e2f895e35.html,,,,,, "Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt",2353-45-9,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3612cdf9-2e31-4a43-8034-ad3429898cc1/documents/IUC5-15948a5f-c039-4267-a361-703c2f4d3dac_a2c0876f-f6cd-48b9-bc0e-c75e2f895e35.html,Chronic toxicity – systemic effects,oral,NOAEL,"7,142.85 mg/kg bw/day",,mouse "Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt",2353-45-9,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3612cdf9-2e31-4a43-8034-ad3429898cc1/documents/IUC5-15948a5f-c039-4267-a361-703c2f4d3dac_a2c0876f-f6cd-48b9-bc0e-c75e2f895e35.html,Chronic toxicity – systemic effects,dermal,NOAEL,"1,428.5 mg/kg bw/day",,mouse "Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt",2353-45-9,"Acute toxicity: Oral The median lethal dose (LD50) value for dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt is estimated to be 5404.28 mg/kg in rats by oral administration. This value indicates that the substance is not likely to be toxic by oral route as per the CLP criteria.Acute toxicity: Dermal The median lethal dose (LD50) value for dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt is estimated to be 2166.13 mg/kg in rats by dermal exposure. This value indicates that the substance is not likely to be toxic by dermal route as per the CLP criteria. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3612cdf9-2e31-4a43-8034-ad3429898cc1/documents/IUC5-584f6f7f-abbd-4b7a-8fe5-ee8698cb55dd_a2c0876f-f6cd-48b9-bc0e-c75e2f895e35.html,,,,,, "Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt",2353-45-9,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3612cdf9-2e31-4a43-8034-ad3429898cc1/documents/IUC5-584f6f7f-abbd-4b7a-8fe5-ee8698cb55dd_a2c0876f-f6cd-48b9-bc0e-c75e2f895e35.html,,oral,LD50,"5,404.28 mg/kg bw",no adverse effect observed, "Dihydrogen (ethyl)[4-[4-[ethyl(3-sulphonatobenzyl)amino](4-hydroxy-2-sulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene](3-sulphonatobenzyl)ammonium, disodium salt",2353-45-9,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3612cdf9-2e31-4a43-8034-ad3429898cc1/documents/IUC5-584f6f7f-abbd-4b7a-8fe5-ee8698cb55dd_a2c0876f-f6cd-48b9-bc0e-c75e2f895e35.html,,dermal,LD50,"2,166.13 mg/kg bw",no adverse effect observed, "Hydrogen [4-[[4-(diethylamino)phenyl][4-[ethyl[(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt",6505-30-2," In an acute oral toxicity study the test substance was applied as a single dose of 2500 mg/kg bw to 10 male Wistar rats per gavage. The animals were inspected for mortality and signs of intoxication during the following 14-day observation period. A dose of 2500 mg/kg body weight was tolerated without signs of poisoning by all animals. The discriminating dose was 2500 mg/kg bw. No acute inhalation or dermal toxicity studies are available. According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’.  The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/635856fa-72b4-432e-88bc-8e53e03bccf0/documents/7e8e2b5c-5f1a-459e-9d54-87e092abe882_26b3d80b-893a-49c7-b544-ed702f8b7627.html,,,,,, "Hydrogen [4-[[4-(diethylamino)phenyl][4-[ethyl[(3-sulphonatobenzyl)amino]-o-tolyl]methylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt",6505-30-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/635856fa-72b4-432e-88bc-8e53e03bccf0/documents/7e8e2b5c-5f1a-459e-9d54-87e092abe882_26b3d80b-893a-49c7-b544-ed702f8b7627.html,,oral,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt",3087-16-9," Combined repeated dose repro-devp. screen was performed for Green S orally in female rats. Wistar female rats were treated with Green S in the concentration of 0, 250, 500 and 1000 mg/kg/day orally by gavage for 19 days. The animals were observed for changes in body weight and gross pathology. No effect was observed on body weight of treated rats as compared to control. Similarly, no effects were observed on reproductive system and the foetuses of treated female rats. In addition, Slightly green colouring in the gastro-intestinal tract and the placental tissue were observed in treated female rats. Green colouring of the gastro-intestinal tract and placenta were observed because Green S is largely unabsorbed. Therefore, No Observed Adverse Effect level (NOAEL) was considered to be 1000 mg/kg/day when Wistar female rats were treated with Green S orally by gavage for 19 days. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/44da5b77-64ff-4c7a-a467-0c03b953112a/documents/f3efbdf0-98fc-4083-8f79-88572d51b43f_5de29790-8ec8-4cbc-b8d3-a0b72378d21d.html,,,,,, "Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt",3087-16-9,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/44da5b77-64ff-4c7a-a467-0c03b953112a/documents/f3efbdf0-98fc-4083-8f79-88572d51b43f_5de29790-8ec8-4cbc-b8d3-a0b72378d21d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt",3087-16-9, LD50 was considered to be > 2000 mg/kg bw in rats. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44da5b77-64ff-4c7a-a467-0c03b953112a/documents/854a756a-7173-435d-a2ac-8cbac6b93c55_5de29790-8ec8-4cbc-b8d3-a0b72378d21d.html,,,,,, "Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt",3087-16-9,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44da5b77-64ff-4c7a-a467-0c03b953112a/documents/854a756a-7173-435d-a2ac-8cbac6b93c55_5de29790-8ec8-4cbc-b8d3-a0b72378d21d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4',5'-dibromo-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one",596-03-2, The test material D and C orange no 5 is not likely to classify as a toxicant upon repeated dosing by the oral and dermal route of exposure. ,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d941629-0a52-4133-a67a-716200ba31d7/documents/IUC5-8c1e42e5-c2d0-40ed-a32e-230f1755ca12_d081b84b-40f4-4faa-8692-d6e08babee7a.html,,,,,, "4',5'-dibromo-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one",596-03-2,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d941629-0a52-4133-a67a-716200ba31d7/documents/IUC5-8c1e42e5-c2d0-40ed-a32e-230f1755ca12_d081b84b-40f4-4faa-8692-d6e08babee7a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,555.737 mg/kg bw/day,,rat "4',5'-dibromo-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one",596-03-2,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d941629-0a52-4133-a67a-716200ba31d7/documents/IUC5-8c1e42e5-c2d0-40ed-a32e-230f1755ca12_d081b84b-40f4-4faa-8692-d6e08babee7a.html,Chronic toxicity – systemic effects,dermal,NOAEL,136.5 mg/kg bw/day,,mouse "4',5'-dibromo-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one",596-03-2,"4',5'-dibromofluorescein is non toxic by oral route. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d941629-0a52-4133-a67a-716200ba31d7/documents/IUC5-80edb330-ac6b-4345-8062-7d74ac3d39a5_d081b84b-40f4-4faa-8692-d6e08babee7a.html,,,,,, "4',5'-dibromo-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one",596-03-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d941629-0a52-4133-a67a-716200ba31d7/documents/IUC5-80edb330-ac6b-4345-8062-7d74ac3d39a5_d081b84b-40f4-4faa-8692-d6e08babee7a.html,,oral,LD50,"4,932.1 mg/kg bw",no adverse effect observed, "Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate]",15876-39-8," Repeated dose toxicity: Oral Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for the test compound 2',4',5',7'-Tetrabromofluorescein aluminum salt. The study assumed the use of male and female Outbred Wistar in 90 days study. No significant alterations were noted at the mentioned dose level. The predicted No Observed Adverse Effect Level (NOAEL) for 2',4',5',7'-Tetrabromofluorescein aluminum salt is considered to be 1079 .5999 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. Repeated dose toxicity: Dermal Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose dermal toxicity was predicted for the test compound 2',4',5',7'-Tetrabromofluorescein aluminum salt. The study assumed the use of male and female New Zealand White rabbits in 28 days study. No significant alterations were noted at the mentioned dose level. The predicted No Observed Adverse Effect Level (NOAEL) for 2',4',5',7'-Tetrabromofluorescein aluminum salt is considered to be 1500.0 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/40aee9f4-f4d1-45e8-ad92-f919ebbd38ec/documents/IUC5-073a0a23-117a-404d-9fad-2d696da3174f_9543bf75-353e-45e3-bbd0-7f60a3a976b7.html,,,,,, "Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate]",15876-39-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/40aee9f4-f4d1-45e8-ad92-f919ebbd38ec/documents/IUC5-073a0a23-117a-404d-9fad-2d696da3174f_9543bf75-353e-45e3-bbd0-7f60a3a976b7.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,079.6 mg/kg bw/day",,rat "Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate]",15876-39-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/40aee9f4-f4d1-45e8-ad92-f919ebbd38ec/documents/IUC5-073a0a23-117a-404d-9fad-2d696da3174f_9543bf75-353e-45e3-bbd0-7f60a3a976b7.html,Chronic toxicity – systemic effects,dermal,NOAEL,"1,500 mg/kg bw/day",,mouse "Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate]",15876-39-8," Acute oral toxicity The  LD50 value was considered to be > 2000 mg/kg body weight. When Sprague Dawley rats were treated with Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate] (CAS No. 15876-39-8) orally. Acute dermal toxicity The acute dermal median lethal dose (LD50) was considered to be >2000 mg/kg bw.When male and female Sprague Dawley rats were treated with Di aluminium  tris [2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate] (15876-39-1) by the dermal route. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40aee9f4-f4d1-45e8-ad92-f919ebbd38ec/documents/IUC5-7eb8fa61-2ee2-4d7a-a697-61b8d275c462_9543bf75-353e-45e3-bbd0-7f60a3a976b7.html,,,,,, "Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate]",15876-39-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40aee9f4-f4d1-45e8-ad92-f919ebbd38ec/documents/IUC5-7eb8fa61-2ee2-4d7a-a697-61b8d275c462_9543bf75-353e-45e3-bbd0-7f60a3a976b7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)benzoate]",15876-39-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40aee9f4-f4d1-45e8-ad92-f919ebbd38ec/documents/IUC5-7eb8fa61-2ee2-4d7a-a697-61b8d275c462_9543bf75-353e-45e3-bbd0-7f60a3a976b7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one",13473-26-2,"Acute oral toxicity:The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value was >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute oral toxicity as 'Not Classified'.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f9a1bec-cae0-4939-961d-688c6a4a7483/documents/f668fd00-2f42-439d-aaf2-83c6596b6b51_4decb126-898a-44f1-af3a-3ad87741489a.html,,,,,, "2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxyspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one",13473-26-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f9a1bec-cae0-4939-961d-688c6a4a7483/documents/f668fd00-2f42-439d-aaf2-83c6596b6b51_4decb126-898a-44f1-af3a-3ad87741489a.html,,oral,LD50,"4,600 mg/kg bw",no adverse effect observed, "2-(3,6-dihydroxy-2,4,5,7-tetraiodoxanthen-9-yl)benzoic acid, aluminium salt",12227-78-0," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The study concluded that the LD50 value is >2000 mg/kg bw for acute oral toxicity.Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.    Acute dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The study concluded that the LD50 value is >2000 mg/kg bw for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2e975b4-4d64-4df4-97b1-7f42b403886a/documents/a4e8625f-72c9-4c36-b016-d6b57aa46b81_31687abf-dc98-44c7-92a8-42fbdfc175eb.html,,,,,, "2-(3,6-dihydroxy-2,4,5,7-tetraiodoxanthen-9-yl)benzoic acid, aluminium salt",12227-78-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2e975b4-4d64-4df4-97b1-7f42b403886a/documents/a4e8625f-72c9-4c36-b016-d6b57aa46b81_31687abf-dc98-44c7-92a8-42fbdfc175eb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-(3,6-dihydroxy-2,4,5,7-tetraiodoxanthen-9-yl)benzoic acid, aluminium salt",12227-78-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2e975b4-4d64-4df4-97b1-7f42b403886a/documents/a4e8625f-72c9-4c36-b016-d6b57aa46b81_31687abf-dc98-44c7-92a8-42fbdfc175eb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3-isobenzofurandione, reaction products with methylquinoline and quinoline",8003-22-3,"The substance 1,3-isobenzofurandione, reaction products with methylquinoline and quinoline (D & C Yellow No. 11) does not exhibit repeated dose toxicity by oral, inhalation and dermal route. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4632472b-135f-4d89-b857-a88353967775/documents/IUC5-c2311c4c-0e6e-4805-864f-678ead648ca7_ee7e5075-cc34-4441-b586-74b3a63218c5.html,,,,,, "1,3-isobenzofurandione, reaction products with methylquinoline and quinoline",8003-22-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4632472b-135f-4d89-b857-a88353967775/documents/IUC5-c2311c4c-0e6e-4805-864f-678ead648ca7_ee7e5075-cc34-4441-b586-74b3a63218c5.html,Short-term repeated dose toxicity – systemic effects,dermal,,"1,000 mg/kg bw/day",,rabbit "1,3-isobenzofurandione, reaction products with methylquinoline and quinoline",8003-22-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4632472b-135f-4d89-b857-a88353967775/documents/IUC5-c2311c4c-0e6e-4805-864f-678ead648ca7_ee7e5075-cc34-4441-b586-74b3a63218c5.html,Chronic toxicity – systemic effects,oral,,83 mg/kg bw/day,,mouse "1,3-isobenzofurandione, reaction products with methylquinoline and quinoline",8003-22-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4632472b-135f-4d89-b857-a88353967775/documents/IUC5-c2311c4c-0e6e-4805-864f-678ead648ca7_ee7e5075-cc34-4441-b586-74b3a63218c5.html,Chronic toxicity – systemic effects,inhalation,,230 mg/m3,,rat "1,3-isobenzofurandione, reaction products with methylquinoline and quinoline",8003-22-3,"Acute toxicity: OralThe acute toxicity of D&C Yellow No. 11 by oral route was estimated using QSAR Toolboox version 3.3 The median lethal dose (LD50) value of the test substance D&C Yellow No. 11 in rats was estimated to be 10200 mg/kg bw. Considering the CLP Criteria for classification of the substance, it is concluded that D&C Yellow No. 11 is not classified for acute oral toxicity to rat. Acute toxicity: InhalationThe Vapour pressure of the substance 1,3-isobenzofurandione, reaction products with methylquinoline and quinolone was found to be 2.73X10-9 mm Hg at 25 deg C (Est) which is equivalent to 0.000000363 Pascal. This the exposure by the inhaltion route is unlikely taking into consideration the low values of vapour pressure.Acute toxicity: DermalThe acute toxicity of D&C Yellow No. 11 by oral route was estimated using QSAR Toolboox version 3.3 The median lethal dose (LD50) value of the test substance D&C Yellow No. 11 in rabbits was estimated to be 4586.48 mg/kg bw. Considering the CLP Criteria for classification of the substance, it is concluded that D&C Yellow No. 11 is not classified for acute oral toxicity to rat. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4632472b-135f-4d89-b857-a88353967775/documents/IUC5-8769d77e-17d7-432c-a882-91093971dccf_ee7e5075-cc34-4441-b586-74b3a63218c5.html,,,,,, "1,3-isobenzofurandione, reaction products with methylquinoline and quinoline",8003-22-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4632472b-135f-4d89-b857-a88353967775/documents/IUC5-8769d77e-17d7-432c-a882-91093971dccf_ee7e5075-cc34-4441-b586-74b3a63218c5.html,,oral,LD50,"10,200 mg/kg bw",no adverse effect observed, "1,3-isobenzofurandione, reaction products with methylquinoline and quinoline",8003-22-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4632472b-135f-4d89-b857-a88353967775/documents/IUC5-8769d77e-17d7-432c-a882-91093971dccf_ee7e5075-cc34-4441-b586-74b3a63218c5.html,,dermal,LD50,"4,586.48 mg/kg bw",no adverse effect observed, "Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes",94891-32-4," Acute oral toxicity: Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes (CAS no.: 94891-32-4). The studies are as mentioned below: 1. The acute oral toxicity study was designed and conducted for test chemical in Sprague Dawley rats. Initially, 3 female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, 3 female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional 3 female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg resulted in diarrhoea (blue colour stools) in all animals with onset at 2 hours and no mortality after the dosing. As no mortality were observed at 24 hours after the dosing, hence additional 3 female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg resulted in diarrhoea (blue colour stools) in all animals with onset at 2 hours and no mortality after the dosing. All animals from 300 mg/kg and 2000 mg/kg dose groups survived through the study period of 14 days. Staining of the stool is attributed to the blue colour of the test item. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups. The acute oral LD50 (Cut-off value) of test chemical was 5000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category Not classified” criteria of CLP. 2. The acute oral toxicity study was designed and conducted for test chemical in Sprague Dawley rats. Initially, 3 female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, 3 female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional 3 female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. As no mortality were observed at 24 hours after the dosing, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups. The acute oral LD50 (Cut-off value) of test chemical was 5000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category Not classified” criteria of CLP. Thus, based on the above summarised studies, Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes (CAS no.: 94891-32-4) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes (CAS no.: 94891-32-4) cannot be classified for acute oral toxicity. Hence, Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes is not toxic for acute oral toxicity. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38a7cbfb-10ca-41f4-a0c3-2810c89328cc/documents/72cf122d-3888-488c-830d-872b957720ea_54d52bc5-9a2a-4191-9edb-2fb51060017e.html,,,,,, "Aluminum, 2-(1,3-dihydro-1,3-dioxo-2H-inden-2-ylidene)-1,2-dihydro-6,7-quinolinedisulfonate complexes",94891-32-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38a7cbfb-10ca-41f4-a0c3-2810c89328cc/documents/72cf122d-3888-488c-830d-872b957720ea_54d52bc5-9a2a-4191-9edb-2fb51060017e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts",95193-83-2, NOAEL (repeated oral toxicity rat chronic study) = 250 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aabf085a-e6ac-4d89-9068-38fafce0afb1/documents/8779ab6e-ab7b-43ea-ad9d-2271b9d703bb_ccd771cf-f378-4952-8f34-1ed9eeb265df.html,,,,,, "1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts",95193-83-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aabf085a-e6ac-4d89-9068-38fafce0afb1/documents/8779ab6e-ab7b-43ea-ad9d-2271b9d703bb_ccd771cf-f378-4952-8f34-1ed9eeb265df.html,Chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts",95193-83-2, LD50 rat oral > 2000 mg/kg bw. LD50 mice oral > 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aabf085a-e6ac-4d89-9068-38fafce0afb1/documents/8c17a2fd-4d35-46de-b89d-d043699c5d81_ccd771cf-f378-4952-8f34-1ed9eeb265df.html,,,,,, "1H-Indene-1,3(2H)-dione, 2-(2-quinolinyl)-, sulfonated, sodium salts",95193-83-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aabf085a-e6ac-4d89-9068-38fafce0afb1/documents/8c17a2fd-4d35-46de-b89d-d043699c5d81_ccd771cf-f378-4952-8f34-1ed9eeb265df.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium 8-hydroxypyrene-1,3,6-trisulphonate",6358-69-6," Repeated dose toxicity: Oral 90 days toxicity study was conducted in rats with test substance fed at dietary levels of 50,500 and 5000mg/kg/day. (100, 1000, 10000 ppm) Therefore No Observed Adverse Effect Level (NOAEL) for repeated oral administration of test substance in rats was considered to be 500mg/kg bw for 90 days by oral feed.   Repeated dose toxicity: inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance Solvent Green 7 also known as Pyranine; trisodium 8-hydroxypyrene-1,3,6-trisulfonate (6358-69-6 ) which is reported as 0.0001860153mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical trisodium 8-hydroxypyrene-1,3,6-trisulfonate is highly unlikely. Therefore this study is considered for waiver. Repeated dose toxicity: dermal In a two year study 60 mice were applied once a week with 3.5 mg substance (0.05 ml of a 7% solution) for 2 years. The No Observed Adverse Effect Level (NOAEL) for repeated dermal exposure to test substance  in 60 mice for 2 years is 3.5 mg (0.05 ml of a 7% solution) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/728eef1e-4fa9-47af-93ad-64c6677b84b7/documents/0f1cb207-e7ad-4b85-bcb1-aa09038f4dea_a0208444-021b-49cd-b28d-54dbb252667f.html,,,,,, "Trisodium 8-hydroxypyrene-1,3,6-trisulphonate",6358-69-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/728eef1e-4fa9-47af-93ad-64c6677b84b7/documents/0f1cb207-e7ad-4b85-bcb1-aa09038f4dea_a0208444-021b-49cd-b28d-54dbb252667f.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Trisodium 8-hydroxypyrene-1,3,6-trisulphonate",6358-69-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/728eef1e-4fa9-47af-93ad-64c6677b84b7/documents/0f1cb207-e7ad-4b85-bcb1-aa09038f4dea_a0208444-021b-49cd-b28d-54dbb252667f.html,Chronic toxicity – systemic effects,dermal,NOAEL,3.5 mg/kg bw/day,,mouse "Trisodium 8-hydroxypyrene-1,3,6-trisulphonate",6358-69-6," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is >15000 mg/kg bw. The study concluded that LD50 is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 2.48E-023 Pa at 25°C. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/728eef1e-4fa9-47af-93ad-64c6677b84b7/documents/00f64b53-4df0-4d19-bd3e-1c476e4f0eed_a0208444-021b-49cd-b28d-54dbb252667f.html,,,,,, "Trisodium 8-hydroxypyrene-1,3,6-trisulphonate",6358-69-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/728eef1e-4fa9-47af-93ad-64c6677b84b7/documents/00f64b53-4df0-4d19-bd3e-1c476e4f0eed_a0208444-021b-49cd-b28d-54dbb252667f.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "Trisodium 8-hydroxypyrene-1,3,6-trisulphonate",6358-69-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/728eef1e-4fa9-47af-93ad-64c6677b84b7/documents/00f64b53-4df0-4d19-bd3e-1c476e4f0eed_a0208444-021b-49cd-b28d-54dbb252667f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-hydroxy-4-(p-toluidino)anthraquinone,81-48-1,"In an OECD Guidelines 407 (Repeated Dose 28 Day Oral Toxicity Study in Rodents, subacute) three groups, each of five male and five female Wistar rats, received test item at dose levels of 250, 500 or 1000 mg/kg bw/day by gavage, for twenty-eight consecutive days. A control group of five males and five females was dosed with vehicle alone (Arachis oil BP). The treatment of rats with test item at dosages 250, 500 or 1000 mg/kg bw/day for twenty eight consecutive days was well tolerated and not associated with any obvious adverse toxicity. Based on the results of this study the No Observed Adverse Effect Level (NOAEL) for the oral administration of test item over twenty eight consecutive days was 1000 mg/kg bw/day (highest applied dose). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a314c8f-4b1e-4d9f-826f-2d28152eb101/documents/e7e0c6f6-ff0c-467d-a78d-43dd49e13b1a_b28c1d44-1a20-41ca-a14f-4e0f21c4ed46.html,,,,,, 1-hydroxy-4-(p-toluidino)anthraquinone,81-48-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a314c8f-4b1e-4d9f-826f-2d28152eb101/documents/e7e0c6f6-ff0c-467d-a78d-43dd49e13b1a_b28c1d44-1a20-41ca-a14f-4e0f21c4ed46.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 1-hydroxy-4-(p-toluidino)anthraquinone,81-48-1,"Several acute oral toxicity studies are available. In the key study a single dose of 5000 mg/kg bw of the test substance was applied to 5 male and 5 female Wistar rats per gavage. The dose of 5000 mg/kg body weight was tolerated without signs of poisoning by all male and female animals. Necropsy of some animals sacrificed at the end of study showed no adverse gross pathological findings. The LD50 is greater than 5000 mg/kg bw (discriminating dose). In the other acute oral toxicity studies LD50 values greater than 5000 mg/kg bw, 10000 mg/kg bw or 2000 mg/kg bw (discriminating dose each) were found.   A study was performed to assess the acute inhalation toxicity of the test item. The method used was designed to be compatible with that described in the OECD Guideline for Testing of Chemicals (2009) No. 436 ""Acute Inhalation Toxicity- Acute Toxic Class Method"" and Method B.52. Acute Inhalation Toxicity-Acute Toxic Class Method, 2014, of Commission Regulation (EC) No. 440/2008. The properties of Macrolex Violett B were shown to be unfavorable to produce a suitable test atmosphere. Mechanical systems designed to produce dust aerosols were unsuccessful in producing a suitable test atmosphere with a particle size that would have been in full compliance with the inhalation test guidelines. It was, therefore, considered to be not possible to generate a suitable test atmosphere from the test item, for use in an inhalation study.  In view of the physical nature of the test item and its apparent low volatility, it is considered unlikely to represent a significant hazard by the inhalation route.   According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’.  The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification.  ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a314c8f-4b1e-4d9f-826f-2d28152eb101/documents/6d75facd-91b5-443a-87c6-dd1ea72ce733_b28c1d44-1a20-41ca-a14f-4e0f21c4ed46.html,,,,,, 1-hydroxy-4-(p-toluidino)anthraquinone,81-48-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a314c8f-4b1e-4d9f-826f-2d28152eb101/documents/6d75facd-91b5-443a-87c6-dd1ea72ce733_b28c1d44-1a20-41ca-a14f-4e0f21c4ed46.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "1,4-bis(p-tolylamino)anthraquinone",128-80-3,"Repeated dose toxicity: Oral Two dogs were fed a diet containing 1 percent Solvent Green 3 during week 1 (290 mg/kg/day); the concentration was increased to 2 percent during week 3 (570 and 500 mg/kg/day) and 3 percent during week 5. The weight normalized doses fluctuated between 610 and 1400 mg/kg/day during the remainder of the experiment. There were no gross signs of toxicity, and no significant changes in body weight. Necropsy revealed only an accumulation of dye in the pelvis of the kidney, in the mucosa of the small and large intestines, in adipose tissue, and in the gall bladder. No histopathological alterations were observed; therefore, Solvent Green 3 was not found to be toxic under the conditions of this test. NOAEL for repeated dose toxicity was considered at 30000 ppm (about 610 to 1400 mg/kg bw/day) in dogs.   Repeated dose toxicity: Inhalation   This end point was considered for waiver since according to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. 1,4-bis(p-tolylamino)anthraquinone has very low vapor pressure of 9.40E-11 Pa (7.05E-013  mmHg). Also, the test chemical has a particle size distribution of 25-150 micron, so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route is considered for waiver.   Repeated dose toxicity: Dermal NOAEL was considered to be 500 mg/kg bw when rabbits were treated with Solvent Green 3 (1,4-bis(p-tolylamino)anthraquinone) for 13 weeks. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e718c15-e57a-4211-a0da-4d7794220926/documents/c97d06e8-61d0-4248-81c6-16be4b2e7dd7_aa593622-ccc2-4a35-b672-b808ce3d8530.html,,,,,, "1,4-bis(p-tolylamino)anthraquinone",128-80-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e718c15-e57a-4211-a0da-4d7794220926/documents/c97d06e8-61d0-4248-81c6-16be4b2e7dd7_aa593622-ccc2-4a35-b672-b808ce3d8530.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,610 mg/kg bw/day,,dog "1,4-bis(p-tolylamino)anthraquinone",128-80-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e718c15-e57a-4211-a0da-4d7794220926/documents/c97d06e8-61d0-4248-81c6-16be4b2e7dd7_aa593622-ccc2-4a35-b672-b808ce3d8530.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rabbit "1,4-bis(p-tolylamino)anthraquinone",128-80-3,"Acute Oral Toxicity (Key study):  The acute oral LD50 of 1,4-bis(p-tolylamino)anthraquinone (BAG) in rats of both sexes observed over a period of 14 days was estimated to be greater than 5000 mg/kg. The study was performed according to OECD 401.   Acute Inhalation Toxicity:  The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely due to the very low vapour pressure of the test item, which is reported to be 9.40E-11 Pa (7.05E-013 mmHg). Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely.   Acute Dermal Toxicity (Key study): The LD50 in male and female New Zealand rabbits, upon a single dermal occlusive dose, with a 14 days post-treatment observation period, was determined to be greater than 2000 mg/kg bw.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e718c15-e57a-4211-a0da-4d7794220926/documents/3455f69a-d42f-49e6-8f9f-c5141f6e3c9a_aa593622-ccc2-4a35-b672-b808ce3d8530.html,,,,,, "1,4-bis(p-tolylamino)anthraquinone",128-80-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e718c15-e57a-4211-a0da-4d7794220926/documents/3455f69a-d42f-49e6-8f9f-c5141f6e3c9a_aa593622-ccc2-4a35-b672-b808ce3d8530.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "1,4-bis(p-tolylamino)anthraquinone",128-80-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e718c15-e57a-4211-a0da-4d7794220926/documents/3455f69a-d42f-49e6-8f9f-c5141f6e3c9a_aa593622-ccc2-4a35-b672-b808ce3d8530.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Disodium 2,2'-(9,10-dioxoanthracene-1,4-diyldiimino)bis(5-methylsulphonate)",4403-90-1,The acute oral toxicity was determined with an internal standard procedure. The test substance has a LD50 > 5000 mg/kg bw. RA - The acute oral toxicity was determined with an internal standard procedure. The test substance has a LD50 > 15000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de237e72-4e66-4b02-a93a-50e5938643ac/documents/IUC5-3f8ecf92-a361-4a04-b2bb-d89d39758509_9ab5d2d7-3391-44c6-a011-e0fa00717b8b.html,,,,,, "Disodium 2,2'-(9,10-dioxoanthracene-1,4-diyldiimino)bis(5-methylsulphonate)",4403-90-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de237e72-4e66-4b02-a93a-50e5938643ac/documents/IUC5-3f8ecf92-a361-4a04-b2bb-d89d39758509_9ab5d2d7-3391-44c6-a011-e0fa00717b8b.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "Sodium 3,3'-(9,10-dioxoanthracene-1,4-diyldiimino)bis(2,4,6-trimethylbenzenesulphonate)",4474-24-2, LD50 = 8850 mg/kg bw (5664 mg/kg bw based on active ingtredient) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7fc03a69-0faf-466b-a8dc-c2329d870859/documents/d7f492eb-fd05-42a2-9d94-bc250aad2985_7f100923-c969-4413-b666-b6b0ccb9f957.html,,,,,, "6,15-dihydroanthrazine-5,9,14,18-tetrone",81-77-6," Repeated Dose Toxicity:- oral, rat, 42 days (OECD422): NOEL (males) = 1000 mg/kg bw/d, N/LOAEL (females) = 1000 mg/kg bw/d; based on reduced food consumption and decreased body weight change during gestation (BASF SE 2012); further old toxicological studies do not show a hazard. In a mechanistic with rat alveolar macrophages it was shown that particles are taken up by macrophages without causing cytotoxicity. The substance is considered to be a passive nanomaterial. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64c58031-a640-4f79-8027-429c136ff7de/documents/f8b6a156-c4ef-4951-99d6-1d63eedc4fd3_27408107-5c9d-4fd2-8f9f-0c68cb6a1fc9.html,,,,,, "6,15-dihydroanthrazine-5,9,14,18-tetrone",81-77-6," - oral: LD50: > 5000 mg/kg bw (rat; Ciba Geigy Ltd. 1986, BASF AG 1979 and 1980; Lu, 1964; Putulina, 1966) - inhalation: LC50 > 5.5 mg/L (rat; BASF AG 1990) - 1 of 10 animals died during exposure. - dermal: LD50 > 1050 mg/kg bw (rat; BASF AG 1975) (testing was performed with a formulation containing 42% of the substance) In accordance with EC regulation 1907/2006, a substance can be assumed as non-hazardous for the dermal route, if no adverse effects were observed for the oral route at the limit dose. Therefore, for the purpose of risk assessment, the LD50 for the dermal route is considered to be greater than 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64c58031-a640-4f79-8027-429c136ff7de/documents/b35af413-1cd2-4591-adca-a54ceeb2fecd_27408107-5c9d-4fd2-8f9f-0c68cb6a1fc9.html,,,,,, "6,15-dihydroanthrazine-5,9,14,18-tetrone",81-77-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64c58031-a640-4f79-8027-429c136ff7de/documents/b35af413-1cd2-4591-adca-a54ceeb2fecd_27408107-5c9d-4fd2-8f9f-0c68cb6a1fc9.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "6,15-dihydroanthrazine-5,9,14,18-tetrone",81-77-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64c58031-a640-4f79-8027-429c136ff7de/documents/b35af413-1cd2-4591-adca-a54ceeb2fecd_27408107-5c9d-4fd2-8f9f-0c68cb6a1fc9.html,,dermal,discriminating dose,"1,050 mg/kg bw",no adverse effect observed, "6,15-dihydroanthrazine-5,9,14,18-tetrone",81-77-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64c58031-a640-4f79-8027-429c136ff7de/documents/b35af413-1cd2-4591-adca-a54ceeb2fecd_27408107-5c9d-4fd2-8f9f-0c68cb6a1fc9.html,,inhalation,discriminating conc.,"5,500 mg/m3",adverse effect observed, "7,16-dichloro-6,15-dihydroanthrazine-5,9,14,18-tetrone",130-20-1," The NOAEL (no observed adverse effect level) for general, systemic toxicity was found to be 1000 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d954a83-de64-4f66-96cc-79f1023e4b9d/documents/e4185c94-e08f-4d24-9675-bb7383d8bba2_da852fac-3fdf-4047-a5a4-9082cf7582a5.html,,,,,, "7,16-dichloro-6,15-dihydroanthrazine-5,9,14,18-tetrone",130-20-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d954a83-de64-4f66-96cc-79f1023e4b9d/documents/e4185c94-e08f-4d24-9675-bb7383d8bba2_da852fac-3fdf-4047-a5a4-9082cf7582a5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "7,16-dichloro-6,15-dihydroanthrazine-5,9,14,18-tetrone",130-20-1," The test substance did not cause any mortality up to a single oral dose of 15000 mg/kg bw. The oral LD0 and LD50 is higher than 15000 mg/kg bw. As the test substance is neither inhalable, nor likely to penetrate the skin due to its physico-chemical properties, further testing was not conducted. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d954a83-de64-4f66-96cc-79f1023e4b9d/documents/15d49497-3ae8-45da-9198-ef3774bfc939_da852fac-3fdf-4047-a5a4-9082cf7582a5.html,,,,,, "Bisbenzimidazo[2,1-b:2',1'-i]benzo[lmn][3,8]phenanthroline-8,17-dione",4424-06-0," Oral repeated dose toxicity: An OECD guideline Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test was performed with the test item (Pigment Orange 43).   The test item was administered to the main groups (10 male and 10 female) by oral gavage at dose levels of 0, 100, 300 and 1000 mg/kg Bwt/day. Recovery groups (5 male and 5 females) received dose levels of 0, and 1000 mg/kg Bwt/day. The dose formulations were administered prior to mating, during mating and post-mating periods for males, and prior to mating, during mating, during pregnancy and up to Lactation Day 13 for females. In the control and high dose recovery groups, the treatment period was followed by a 14 day no treatment (recovery) period. Animals in the recovery groups were not mated.   No toxicologically significant changes were noted in any of the parameters investigated in this study (such as clinical signs, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). A No Observed Adverse Effect Level (NOAEL) for the test item for repeated dose toxicity of 1000 mg/kg/day was established. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/396a4b52-7151-4aac-8d77-2fa810531992/documents/cc84e759-0afd-4c7c-9901-f79fa142ae2b_2d517077-0fa5-492a-b6a7-dd69356f6e17.html,,,,,, "Bisbenzimidazo[2,1-b:2',1'-i]benzo[lmn][3,8]phenanthroline-8,17-dione",4424-06-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/396a4b52-7151-4aac-8d77-2fa810531992/documents/cc84e759-0afd-4c7c-9901-f79fa142ae2b_2d517077-0fa5-492a-b6a7-dd69356f6e17.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Bisbenzimidazo[2,1-b:2',1'-i]benzo[lmn][3,8]phenanthroline-8,17-dione",4424-06-0," Acute oral toxicity: The test item (Pigment Orange 43) did not cause any mortality or clinical signs after single oral gavage administration to female rats at 2000 mg/kg bw in a valid guideline study. The relevance and the reason for the congestion in the lungs in three of six animals at necropsy was unclear beacause no impairment of breathing was observed no signs of toxicity were observed in another acute oral toxicity study in mice (max. dose 10000 mg/kg) and no congestion in the lungs or impairment of breathing were observed in a Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test in rats (max. dose: 1000 mg/kg bw/d). Acute dermal toxicity: Study was waived and classification for this endpoint is considered unwarranted, beacause the substance is not likely to become systemically available after dermal exposure and there was no evidence of toxicity observed in any of the endpoints tested. Acute inhalation toxicity: Study was waived and classification for this endpoint is considered unwarranted. When aerosolized in respirable form, the substance is considered likely to behave like an inert dust. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/396a4b52-7151-4aac-8d77-2fa810531992/documents/d484f63d-da9f-4dbc-9cc9-de45bbf9adbb_2d517077-0fa5-492a-b6a7-dd69356f6e17.html,,,,,, "Bisbenzimidazo[2,1-b:2',1'-i]benzo[lmn][3,8]phenanthroline-8,17-dione",4424-06-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/396a4b52-7151-4aac-8d77-2fa810531992/documents/d484f63d-da9f-4dbc-9cc9-de45bbf9adbb_2d517077-0fa5-492a-b6a7-dd69356f6e17.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-1,2-dihydro-3H-indol-3-one",482-89-3,"There were no adverse effects noted up to the highest dose levels tested, with Indigo containing up to 3% aniline and methylaniline as a sum. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30025889-089d-489c-b361-7ec794c3b720/documents/IUC5-c9a433d5-f65f-4f15-afab-1f2998bba518_8e8f8f9f-8fc4-4c1e-a97c-71c5e6241c7d.html,,,,,, "2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-1,2-dihydro-3H-indol-3-one",482-89-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30025889-089d-489c-b361-7ec794c3b720/documents/IUC5-c9a433d5-f65f-4f15-afab-1f2998bba518_8e8f8f9f-8fc4-4c1e-a97c-71c5e6241c7d.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat "2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-1,2-dihydro-3H-indol-3-one",482-89-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30025889-089d-489c-b361-7ec794c3b720/documents/IUC5-c9a433d5-f65f-4f15-afab-1f2998bba518_8e8f8f9f-8fc4-4c1e-a97c-71c5e6241c7d.html,Chronic toxicity – systemic effects,dermal,NOAEL,25 mg/kg bw/day,,mouse "2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-1,2-dihydro-3H-indol-3-one",482-89-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30025889-089d-489c-b361-7ec794c3b720/documents/IUC5-6566c664-6993-4421-b377-330fa914407c_8e8f8f9f-8fc4-4c1e-a97c-71c5e6241c7d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-1,2-dihydro-3H-indol-3-one",482-89-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30025889-089d-489c-b361-7ec794c3b720/documents/IUC5-6566c664-6993-4421-b377-330fa914407c_8e8f8f9f-8fc4-4c1e-a97c-71c5e6241c7d.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, "2-(1,3-dihydro-3-oxo-2H-indol-2-ylidene)-1,2-dihydro-3H-indol-3-one",482-89-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30025889-089d-489c-b361-7ec794c3b720/documents/IUC5-6566c664-6993-4421-b377-330fa914407c_8e8f8f9f-8fc4-4c1e-a97c-71c5e6241c7d.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "5,12-dihydroquino[2,3-b]acridine-7,14-dione",1047-16-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): valid and reliable. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): valid and reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26360e6c-7ddf-4007-b01b-4e71a3313818/documents/7c926aeb-40a2-42f6-8798-1179da409e21_a89be6f1-9309-440b-b0bf-a489ad98b62e.html,,,,,, "5,12-dihydroquino[2,3-b]acridine-7,14-dione",1047-16-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26360e6c-7ddf-4007-b01b-4e71a3313818/documents/7c926aeb-40a2-42f6-8798-1179da409e21_a89be6f1-9309-440b-b0bf-a489ad98b62e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "5,12-dihydroquino[2,3-b]acridine-7,14-dione",1047-16-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26360e6c-7ddf-4007-b01b-4e71a3313818/documents/7c926aeb-40a2-42f6-8798-1179da409e21_a89be6f1-9309-440b-b0bf-a489ad98b62e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.1 mg/L,,rat "5,12-dihydroquino[2,3-b]acridine-7,14-dione",1047-16-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26360e6c-7ddf-4007-b01b-4e71a3313818/documents/7c926aeb-40a2-42f6-8798-1179da409e21_a89be6f1-9309-440b-b0bf-a489ad98b62e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.1 mg/L,no adverse effect observed,rat "5,12-dihydroquino[2,3-b]acridine-7,14-dione",1047-16-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): reliable ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26360e6c-7ddf-4007-b01b-4e71a3313818/documents/2137c3f7-3c1d-44e2-8e96-86bdc46627a4_a89be6f1-9309-440b-b0bf-a489ad98b62e.html,,,,,, "5,12-dihydroquino[2,3-b]acridine-7,14-dione",1047-16-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26360e6c-7ddf-4007-b01b-4e71a3313818/documents/2137c3f7-3c1d-44e2-8e96-86bdc46627a4_a89be6f1-9309-440b-b0bf-a489ad98b62e.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "5,12-dihydroquino[2,3-b]acridine-7,14-dione",1047-16-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26360e6c-7ddf-4007-b01b-4e71a3313818/documents/2137c3f7-3c1d-44e2-8e96-86bdc46627a4_a89be6f1-9309-440b-b0bf-a489ad98b62e.html,,inhalation,LC50,> 3.1 mg/L,no adverse effect observed, "5,12-dihydro-2,9-dimethylquino[2,3-b]acridine-7,14-dione",980-26-7,"The toxicity of the test item (Pigment Red 122) when given by oral administration (gavage) to rats for 13 consecutive weeks at dosages of 0, 50, 200 or 1000 mg/kg bw/day, for 7 days/week and recovery from any treatment-related effects over a recovery period of 4 weeks, have been investigated. No toxicological alterations were observed during the in vivo phase at the following investigations: pre- and post-dose observations, clinical signs, neurotoxicity assessment, sensory reaction to stimuli, motor activity, body weight, food consumption, ophthalmoscopy and clinical pathology investigations. Necropsy gross observations and histopathological examination were performed after sacrifice of animals at the end of treatment and recovery periods, and no toxicologically relevant changes were observed. On the basis of these results, the high dose level of 1000 mg/kg/day was considered to be the No Observed Adverse Effect Level (NOAEL). Liver and blood plasma samples of male and female rats of the 1000 mg/kg bw/day group were below quantifiable limit concentrations of 1.5 ug/g dried liver and 0.4 / 0.6 ppm dried blood plasma, indicating that the test item is not or only to a negligible extent bioavailable. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77d9dd07-0a91-493d-a742-98d52105e8f8/documents/fada9a6e-f6a8-494b-9398-5ba8bd618931_13c1098e-eb9a-4dc3-96ad-0497c2bd5e34.html,,,,,, "5,12-dihydro-2,9-dimethylquino[2,3-b]acridine-7,14-dione",980-26-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77d9dd07-0a91-493d-a742-98d52105e8f8/documents/fada9a6e-f6a8-494b-9398-5ba8bd618931_13c1098e-eb9a-4dc3-96ad-0497c2bd5e34.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "5,12-dihydro-2,9-dimethylquino[2,3-b]acridine-7,14-dione",980-26-7,"The median lethal dose (LD50) of test item (Pigment Red 122) after a single oral administration to female rats, observed over a period of 14 days, was greater than 2000 mg/kg body weight. No mortality was observed after nose-only inhalation exposure to the test item (Pigment Red 122) of male and female rats at the highest technically achievable aerosol concentration of 3.055 mg/L for 4 hours. Based on the lack of lethal effects, severe clinical symptoms indicating a life-threatening or moribund state, and gross morphological abnormalities, it may be reasonably assumed that the LC50 for the test item is greater than 5 mg/l air. Pigment Red 122 caused no mortality in male and female rabbits after a single dermal application of 3000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77d9dd07-0a91-493d-a742-98d52105e8f8/documents/17e88550-795a-434b-8fb6-832717e6baac_13c1098e-eb9a-4dc3-96ad-0497c2bd5e34.html,,,,,, "5,12-dihydro-2,9-dimethylquino[2,3-b]acridine-7,14-dione",980-26-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77d9dd07-0a91-493d-a742-98d52105e8f8/documents/17e88550-795a-434b-8fb6-832717e6baac_13c1098e-eb9a-4dc3-96ad-0497c2bd5e34.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "5,12-dihydro-2,9-dimethylquino[2,3-b]acridine-7,14-dione",980-26-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77d9dd07-0a91-493d-a742-98d52105e8f8/documents/17e88550-795a-434b-8fb6-832717e6baac_13c1098e-eb9a-4dc3-96ad-0497c2bd5e34.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, "5,12-dihydro-2,9-dimethylquino[2,3-b]acridine-7,14-dione",980-26-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77d9dd07-0a91-493d-a742-98d52105e8f8/documents/17e88550-795a-434b-8fb6-832717e6baac_13c1098e-eb9a-4dc3-96ad-0497c2bd5e34.html,,inhalation,LC50,"3,050 mg/m3",no adverse effect observed, "29H,31H-phthalocyanine",574-93-6,"- Oral: NOAEL = 1000 mg/kg bw/day, subchronic - Inhalation: NOAEC = 30 mg/m3, subacute ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75724a25-28f0-42a5-a2d9-b86d9dca5ad8/documents/73754c81-3310-4a82-82a6-1dc06cb6fa2e_9cf92e30-8020-425b-816a-fe9aa6aa8dfd.html,,,,,, "29H,31H-phthalocyanine",574-93-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75724a25-28f0-42a5-a2d9-b86d9dca5ad8/documents/73754c81-3310-4a82-82a6-1dc06cb6fa2e_9cf92e30-8020-425b-816a-fe9aa6aa8dfd.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat "29H,31H-phthalocyanine",574-93-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75724a25-28f0-42a5-a2d9-b86d9dca5ad8/documents/73754c81-3310-4a82-82a6-1dc06cb6fa2e_9cf92e30-8020-425b-816a-fe9aa6aa8dfd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "29H,31H-phthalocyanine",574-93-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75724a25-28f0-42a5-a2d9-b86d9dca5ad8/documents/73754c81-3310-4a82-82a6-1dc06cb6fa2e_9cf92e30-8020-425b-816a-fe9aa6aa8dfd.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat "29H,31H-phthalocyanine",574-93-6,- Oral: LD50 > 2000 mg/kg bw - Inhalation: LC50 > 2.046 mg/L air - Dermal: LD50 > 5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75724a25-28f0-42a5-a2d9-b86d9dca5ad8/documents/4eb6dec5-cdb7-4d5c-86c1-1366c14a35fd_9cf92e30-8020-425b-816a-fe9aa6aa8dfd.html,,,,,, "29H,31H-phthalocyanine",574-93-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75724a25-28f0-42a5-a2d9-b86d9dca5ad8/documents/4eb6dec5-cdb7-4d5c-86c1-1366c14a35fd_9cf92e30-8020-425b-816a-fe9aa6aa8dfd.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "29H,31H-phthalocyanine",574-93-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75724a25-28f0-42a5-a2d9-b86d9dca5ad8/documents/4eb6dec5-cdb7-4d5c-86c1-1366c14a35fd_9cf92e30-8020-425b-816a-fe9aa6aa8dfd.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "29H,31H-phthalocyanine",574-93-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75724a25-28f0-42a5-a2d9-b86d9dca5ad8/documents/4eb6dec5-cdb7-4d5c-86c1-1366c14a35fd_9cf92e30-8020-425b-816a-fe9aa6aa8dfd.html,,inhalation,LC50,> 2.046 mg/L,no adverse effect observed, "29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper",147-14-8, Oral: sub-chronic repeated dose toxicity study in rats (similar to OECD TG 408; pre-GLP): NOAEL = ca. 4500 mg/kg bw/d (highest tested dose) Inhalation: short-term inhalation lung toxicity study in rats: NOAEC = 30 mg/m³ (highest tested concentration) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e0e44a2-3ee9-4829-a2f5-d1f48d68c134/documents/IUC5-1ec511f1-902c-447a-a13d-e5d090aa3c66_9465652f-a9e4-4a7e-a09a-e666bee9edd5.html,,,,,, "29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper",147-14-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e0e44a2-3ee9-4829-a2f5-d1f48d68c134/documents/IUC5-1ec511f1-902c-447a-a13d-e5d090aa3c66_9465652f-a9e4-4a7e-a09a-e666bee9edd5.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat "29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper",147-14-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e0e44a2-3ee9-4829-a2f5-d1f48d68c134/documents/IUC5-1ec511f1-902c-447a-a13d-e5d090aa3c66_9465652f-a9e4-4a7e-a09a-e666bee9edd5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"4,500 mg/kg bw/day",,rat "29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper",147-14-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e0e44a2-3ee9-4829-a2f5-d1f48d68c134/documents/IUC5-1ec511f1-902c-447a-a13d-e5d090aa3c66_9465652f-a9e4-4a7e-a09a-e666bee9edd5.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat "29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper",147-14-8," Oral: LD50 (rat) > 6400 mg/kg bw (pre-GLP study similar to OECD TG 401) Dermal: LD50 (rat) > 5000 mg/kg bw (non-GLP study accroding to OECD TG 402) Inhalation: LC50 (rat) > 2 mg/L bw (read-across, GLP study accroding to OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e0e44a2-3ee9-4829-a2f5-d1f48d68c134/documents/IUC5-486972e9-372f-4f10-99f7-2d7d3e4f6278_9465652f-a9e4-4a7e-a09a-e666bee9edd5.html,,,,,, "29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper",147-14-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e0e44a2-3ee9-4829-a2f5-d1f48d68c134/documents/IUC5-486972e9-372f-4f10-99f7-2d7d3e4f6278_9465652f-a9e4-4a7e-a09a-e666bee9edd5.html,,oral,discriminating dose,"6,400 mg/kg bw",no adverse effect observed, "29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper",147-14-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e0e44a2-3ee9-4829-a2f5-d1f48d68c134/documents/IUC5-486972e9-372f-4f10-99f7-2d7d3e4f6278_9465652f-a9e4-4a7e-a09a-e666bee9edd5.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Disulfo copper phthalocyanine amine salt,1328-51-4," Repeated dose subacute toxicity study was performed to determine the toxic nature of Direct blue 86 (EC name: Disulfo copper phthalocyanine amine salt). The chemical was administered by oral gavage route at dose levels of 0 or 1000 mg/Kg bw/day to 20 male and 20 females rats in a standard volume of 10 mL/kg. The treatment period was followed by a 15 day recovery period. 22 daily doses were given over a period of 30 days i.e 5 times/week, 1 dose/day for 4 weeks plus Monday and Tuesday of the last week. The doses were selectedwere selected on the basis of acute oral LD50 study. The oral LD50 value in rats was in excess of 5000 mg/Kg bw/day and no signs of toxicity were noted and hence the dose was subacute study was selected to be 1000 mg/Kg bw/day. Each day, clinical signs and body weights were recorded. Food intake was determined on a weekly basis. At the end of the treatment and the recovery period, hematology, blood chemistry, and urinalysis measurements were carried out by standard methods on animals from control and test groups. At the end of the treatment period or after the recovery period, each rat was examined externally and by dissection for macroscopic abnormalities. Each rat was autopsied and selected organs, including liver, kidneys, adrenals, and spleen were submitted for histopathological examination, following determination of the organ weights. Other organ tissues were fixed in formalin and are held for reference in the archives. Appropriate statistical analyses were performed on the different measurements. No mortality or signs of toxicity were observed during the study period and food and water consumption were within the normal range following treatment with the eight selected colorants. There was evidence of absorption, based on the coloration of urine and/or tissues following treatment with Direct Blue 86. Comparison of the urinalysis of test and control animals, and all bilirubin and urobilinogen tests were negative. The clinical examinations of liver function revealed no signs of toxicity following treatment and recovery. No overall effects were observed on the hematological profiles of the test animals compared with the controls. The statistical analyses did not reveal evidence for any treatment-related effects on liver or adrenals weights. The kidney weights were increased at termination of treatment with Direct Blue 86, and Direct Blue 15, but were normal after the 2-week recovery. This effect may relate to the morphological changes of the tubules of the kidneys, which were seen at the end of the treatment period, but not after the recovery period. Other histopathological examinations of selected tissues showed no significant effects related to the treatment.   The No Observed Adverse Effect Level (NOAEL) for Direct blue 86 in male and female rats is 1000 mg/Kg bw/day. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a3d7239-f32e-47cb-8846-15aa8fc1fb05/documents/04cb3b00-7ced-4812-b7de-938a765f4b37_4d6077ec-af6f-4582-9ed4-9b9c08445b34.html,,,,,, Disulfo copper phthalocyanine amine salt,1328-51-4,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a3d7239-f32e-47cb-8846-15aa8fc1fb05/documents/04cb3b00-7ced-4812-b7de-938a765f4b37_4d6077ec-af6f-4582-9ed4-9b9c08445b34.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Disulfo copper phthalocyanine amine salt,1328-51-4," Disulfo copper phthalocyanine amine salt (CAS no 1328-51-4) ) and it’s structurally similar read across Phthalocyanine, metal free is likely to be non hazardous by oral route of exposure. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a3d7239-f32e-47cb-8846-15aa8fc1fb05/documents/2bc6ef77-0942-4d65-b289-8e593b92e843_4d6077ec-af6f-4582-9ed4-9b9c08445b34.html,,,,,, Disulfo copper phthalocyanine amine salt,1328-51-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a3d7239-f32e-47cb-8846-15aa8fc1fb05/documents/2bc6ef77-0942-4d65-b289-8e593b92e843_4d6077ec-af6f-4582-9ed4-9b9c08445b34.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Polychloro copper phthalocyanine,1328-53-6, Pigment Green 7 did not cause adverse effects at the limit dose in subacute gavage and subchronic feeding studies. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2717f66b-eb6d-4f08-806a-e69099ab3b36/documents/efa0defe-6c5e-4bc1-9bd3-897544adb044_24cb87cc-04b3-46c1-b8a7-3ab280d6b744.html,,,,,, Polychloro copper phthalocyanine,1328-53-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2717f66b-eb6d-4f08-806a-e69099ab3b36/documents/efa0defe-6c5e-4bc1-9bd3-897544adb044_24cb87cc-04b3-46c1-b8a7-3ab280d6b744.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Polychloro copper phthalocyanine,1328-53-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2717f66b-eb6d-4f08-806a-e69099ab3b36/documents/ebef157e-7f9d-4fd3-8f93-0b05cf252983_24cb87cc-04b3-46c1-b8a7-3ab280d6b744.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Polychloro copper phthalocyanine,1328-53-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2717f66b-eb6d-4f08-806a-e69099ab3b36/documents/ebef157e-7f9d-4fd3-8f93-0b05cf252983_24cb87cc-04b3-46c1-b8a7-3ab280d6b744.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Carmine,1390-65-4, The dossier is submitted under DCG issue 10.3 as communicated to ECHA in communication INC000000234289. Incomplete endpoint summary records are indicated in the relevant sections of the dossier. Complete information is not availabole for CSR or Guidance on safe use. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba36e849-c613-4c1a-b7b3-664b5b889c41/documents/fd46f1dc-77a4-4277-87f5-a1e3e97f2f24_1ea70b71-ff39-4b19-b137-fcde158645b5.html,,,,,, Diiron trioxide,1309-37-1,"A subacute inhalation toxicity study for Fe3O4, Fe2O3 and FeOOH and a subchronic inhalation study for Fe3O4 are available. Additionally, a short-term (5-day) inhalation study with two different grades of nanomaterials was conducted. Rats were exposed to 10 and 30 mg/m³ of smaller nano-sized Fe2O3 and 30 mg/m³ of larger nano-sized Fe2O3. Based on the information from a 90-day repeated dose oral toxicity study in rats (according to OECD 408, GLP) it is concluded that the Fe3O4 does not show any adverse effects up to the highest dose level of 1000 m/kg bw/day. For dermal toxicity no reliable repeated dose toxicity studies are available for the iron oxide category. Details on the category justification are given in the read-across document attached in IUCLID section 13.2. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7885b815-92bb-42cd-aa73-f6fefb1f88f2/documents/IUC5-e1e183e8-5f42-4f02-a3ee-4ee8b71651c1_7842cf91-f6e7-4482-a588-58ca686018ca.html,,,,,, Diiron trioxide,1309-37-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7885b815-92bb-42cd-aa73-f6fefb1f88f2/documents/IUC5-e1e183e8-5f42-4f02-a3ee-4ee8b71651c1_7842cf91-f6e7-4482-a588-58ca686018ca.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4.7 mg/m3,adverse effect observed,rat Diiron trioxide,1309-37-1,"Acute toxicity, oral: LD50 > 5000mg/kg bw Acute toxicity, inhalation: LC50 > 5,05mg/L Acute toxicity, dermal: Conduct of an acute dermal toxicity study is unjustified as inhalation of the substance is considered as major route of exposure and physicochemical properties and dermal absorption data of the substance do not suggest a significant rate of absorption through the skin (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7885b815-92bb-42cd-aa73-f6fefb1f88f2/documents/IUC5-c7acdfa4-0734-4bb2-a1ea-466284c3c418_7842cf91-f6e7-4482-a588-58ca686018ca.html,,,,,, Diiron trioxide,1309-37-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7885b815-92bb-42cd-aa73-f6fefb1f88f2/documents/IUC5-c7acdfa4-0734-4bb2-a1ea-466284c3c418_7842cf91-f6e7-4482-a588-58ca686018ca.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Diiron trioxide,1309-37-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7885b815-92bb-42cd-aa73-f6fefb1f88f2/documents/IUC5-c7acdfa4-0734-4bb2-a1ea-466284c3c418_7842cf91-f6e7-4482-a588-58ca686018ca.html,,inhalation,discriminating conc.,"5,050 mg/m3",no adverse effect observed, Bismuth chloride oxide,7787-59-9," Oral (WoE, 90 d, rat): NOAEL 5000 mg/kg bw/d (female/male) Oral (WoE, 90 d, rat): NOAEL 1000 mg/kg bw/d (female/male) Read-across from source substance bismuth hydroxide nitrate oxide (CAS 1304-85-4) Dermal (WoE, 28 d, rabbit): NOAEL = 500 mg/kg bw/d (female/male) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e65b44df-5957-4a19-acc4-05927846b735/documents/57561158-94a9-4fa4-8f7a-85e2da25110c_d93af30a-481d-445a-8b4c-4fdc5cbad3e1.html,,,,,, Bismuth chloride oxide,7787-59-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e65b44df-5957-4a19-acc4-05927846b735/documents/57561158-94a9-4fa4-8f7a-85e2da25110c_d93af30a-481d-445a-8b4c-4fdc5cbad3e1.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rabbit Bismuth chloride oxide,7787-59-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e65b44df-5957-4a19-acc4-05927846b735/documents/57561158-94a9-4fa4-8f7a-85e2da25110c_d93af30a-481d-445a-8b4c-4fdc5cbad3e1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Bismuth chloride oxide,7787-59-9," Acute toxicity, oral (similar to OECD 401): LD50 > 10000 mg/kg bw (50% test substance in water) Acute toxicity, oral (similar to OECD 401): LD50 > 10000 mg/kg bw (70% test substance in castor oil) Acute toxicity, inhalation (OECD 436): LC50 > 5.07 mg/L air RA from source substance Bismuth trioxide (CAS 1304-76-3) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e65b44df-5957-4a19-acc4-05927846b735/documents/46622ff1-05c3-4ddd-bc4f-1dbbffff88e5_d93af30a-481d-445a-8b4c-4fdc5cbad3e1.html,,,,,, Carbon black,1333-86-4," A relevant systemic exposure to carbon black is not expected after oral, dermal or respiratory administration (see section on toxicokinetics for rationale of conclusion). Oral & Dermal Routes There were no adverse effects found in a 90-day GLP and guideline study after repeated oral administration by gavage. The repeated daily oral administration of carbon black for 13 weeks at 100, 300 or 1000 mg/kg/day was well tolerated by the rats; with some non-adverse findings related to the staining properties of carbon black. Accordingly, under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) was 1000 mg/kg/day (SCCS 2015). Extensive, but old studies in mice with carbon black application via the oral and dermal routes have not indicated any adverse effects, even at excessive dose levels (10% in feed, 20% suspensions for dermal application). In a chronic toxicity/carcinogenicity study, no changes were observed in organs or tissues of mice fed with various types of carbon blacks (10% CB in the diets) for 12 to 18 months (Nau, Neal et al. 1958). Another study investigating effects of ingested carbon black in rats and mice has not found any effect on tissues or organs after 2 years of exposure to a dose level equivalent to 52 or 137 mg/kg bw/day in rats and mice, respectively (Pence and Buddingh 1985). In an old study with limited documentation, no changes were found in organs or tissues of C3H male mice treated three times per week (for a total of 41 weeks) with various types of carbon black (20% carbon black suspensions in cottonseed oil, mineral oil or in 1% aqueous carboxymethylcellulose, painted onto the animals’ backs) (Nau, Neal et al. 1958). These findings are consistent with toxicokinetic evidence on carbon black; a GLP dermal penetration study was performed using the OECD 428 protocol with full-thickness human skin samples and transmission electron microscopy for semi-quantitative evaluation of dermal permeation. No permeation of carbon black particles from a cosmetic eyeliner formulation into or beyond the outer layer of the stratum corneum was found. Inhalation Lung toxicity and respiratory effects as well as particle retention kinetics, inflammation, and histopathology were examined in female rats, mice, and hamsters exposed for 13 weeks to high surface area carbon black (Printex 90, 300 m2/g HSCb, MMAD 1.2 - 2.4 µm) at doses of 0, 1, 7, and 50 mg/m3. A group of rats was also exposed to 50 mg/m3 of a low surface area carbon black (Sterling V, 37 m2/g LSCb, MMAD 0.6 - 0.9 µm). Groups of animals were sacrificed immediately, after 13 weeks of exposure, and after a 3- and 11-months recovery period for bronchoalveolar lavage (BAL) analysis, as well as for measurements of lung burdens and lung and nasal histopathology (Elder et al. 2005, Santhanam et al. 2008). Prolonged retention was found in rats exposed to mid- and high-dose HSCb and to LSCb, but LSCb was cleared faster than HSCb. Retention was also prolonged in mice exposed to mid- and high-dose HSCb, and in hamsters exposed to high-dose HSCb. Lung inflammation and histopathology were more severe and prolonged in rats than in mice and hamsters, with both parameters occurring at a similar magnitude in rats exposed to mid-dose HSCb (7 mg/m3) and LSCb (50 mg/m3). The results show that, of the three species investigated, hamsters have the most efficient clearance machinery and the least severe responses. The results from rats also show that particle surface area is an important determinant of target tissue dose and, therefore, effects. From these results, a sub-chronic NOAEC of 1mg/m3 respirable HSCb can be assigned to female rats, mice, and hamsters. A sub-chronic inhalation study was also performed in male Fischer 344 rats using respirable carbon black (Driscoll et al. 1996). Groups of male rats (4 per group) were exposed to 0, 1.1, 7.1 or 52.8 mg/m3 Monarch 880 (not treated) for 13 weeks (6 hr/d, 5d/week). The MMAD was 0.88 µm, and the specific surface area 220 m2/g. Groups of animals were sacrificed immediately after 13 weeks of exposure, and after a 3- and 8-months recovery period for bronchoalveolar lavage analysis, as well as for measurements of lung burden and lung histopathology. No pathological or biochemical changes were found in the lungs at 1.1mg/m3 (NOAEC), but there were clear dose-related increases in both biochemical and cellular markers of lung damage at the mid- and high exposure levels. Lung burdens at the end of the exposure period were 0.35, 1.8 and 7.8 mg for the low, mid and high dose groups, respectively. By 8 months, there was substantial clearance of the carbon black retained in the lungs in the low exposure group, moderate clearance in the mid- exposure group and very little clearance in the high exposure group. No increases in markers of inflammation and lung damage were reported in the low exposure group, but there were clear dose-related increases in both biochemical and cellular markers of lung damage with the two higher exposure concentrations. Histopathology revealed particle-containing macrophages located in the alveolar and alveolar duct regions of the lungs of rats exposed to 1.1 mg/m3. In contrast, rats exposed to 7.1 mg/m3 showed evidence of inflammation characterised by accumulation of neutrophils and macrophages within the alveolar spaces. There was also evidence for focal and random areas of mild epithelial hyperplasia and mild interstitial fibrosis. Exposure to 52.8 mg/m3 showed more pronounced epithelial hyperplasia and fibrosis. Fibrosis was greatest after the 8 -month recovery period. Severe lung damage (including lung tumours) was seen in Fischer 344 rats of both sexes exposed for 2 years to 2.5 and 6.5 mg/m3 (16 hrs/day, 5 days/week) (see section on carcinogenicity for full details). The lung weights of all exposure groups increased in an almost linear manner throughout the exposure period. Exposure-related lesions consisted of alveolar macrophage hyperplasia, alveolar epithelial hyperplasia, chronic-active inflammation, septal fibrosis, alveolar proteinosis, bronchiolar alveolar metaplasia, focal fibrosis with alveolar epithelial hyperplasia, squamous metaplasia and squamous cysts (Nikula et al. 1995). In a inhalation study that investigating the effects of agglomeration on toxicity of carbon black, Lim et al 2012 reported no changes in body weight, cytokine levels in the BAL fluid or blood biochemical and haematological parameters following nose only exposure of male Sprague Dawley rats to ca. 9 mg/m3 Printex 90 (6 hr/day, 5 days/week) for 90 days. Numbers of total cells in the bronchoalveolar lavage (BAL) fluid, macrophages, and polymorphonuclear leukocytes were increased and carbon black masses were clearly seen in BAL cells and lung tissues of rats exposed to Printex 90. However, few differences were found between the three differently agglomerated aerosols (Lim et al. 2012) The above inhalation studies on carbon black focussed on investigations on effects in the lungs. Reliable repeated dose studies investigating effects to organs beyond the lungs after inhalation exposure are not available. However, as reported above, a 90-day guideline study via the oral route is available. It is note that as per guideline recommendation, this study addressed effects on all relevant systemic organs. From data on MPPD modelling using information on dustiness generated for Printex 90, it can be concluded that for rat and humans, the overwhelming majority of airborne particles will impact in the upper regions of the respiratory tract and will end up in the gastrointestinal tract (EBRC Consulting GmbH 2019): 1) Carbon black (based on dustiness studies for Printex 90) is predicted to have a limited deposition ability in the entire human respiratory tract; only 64.2 % of airborne material is estimated to be deposited in the human, while 35.5°% of the airborne material will deposit in the rat lung. The predominant portion of the deposited material is predicted to impact the pharynx and subsequently is most likely to be swallowed. The rest of the airborne material is not inhaled due to physical phenomena related to air streams and turbulences close to the mouth or simply exhaled (i.e. not deposited). 2) Of the inhaled fraction, only about 3.3 % or less are predicted to deposit in the deep pulmonary region (PU) of the human lung, respectively 2.0 % of the rat lung, whereas the material deposited in the tracheobronchial (TB) and the extra-thoracic region (Head) (in total: ca. 60%) may be assumed to be cleared to the GI tract (i.e., by mucociliary escalation and subsequent swallowing. From the above, it is shown that when rats and humans are exposed to airborne particles of carbon black, almost all of the deposited material would contribute to oral and not to inhalation exposure (EBRC Consulting GmbH 2019). These predictions and conclusions from MPPD modelling are validated by empirical data; Mauderly et al 1994 subjected rats to counts of radioactivity to determine the amounts of 7Be carbon black present at 0, 4, 7, 13, 28, 35, 42, 56, 73, 84, 98, 112, and 126 days after nose only inhalation exposure to [7Be]-labelled carbon black in male and female rats. They reported that by day 7, radioactivity in the head, large airways, and gastrointestinal tract was already negligible due to early mucociliary clearance from the lung. In another study, Southam et al (2002) quantified the relative distribution achieved with intranasal delivery of a non-absorbable tracer, 99mTc-labeled sulphide colloid in upper and lower respiratory tract (URT and LRT) in mice. Over the course of 1 h following instillation of 50 µl of the tracer particles, radiation in the URT decreased and appeared in the gastrointestinal tract (Southam et al 2002). Whereas ECHA guidance R7a states that testing by the inhalation route is appropriate when testing nanomaterials for certain endpoints like repeated dose toxicity if human inhalation exposure is likely. However, tests via the inhalation route and the interpretation of their results are inherently limited due to the alveolar macrophage overload effects and the corresponding impairment of respiratory function. We submit therefore that the possibility of exposure to particles of an inhalable size (aerodynamic diameter below 100 μm) has to be viewed in combination with their deposition kinetics in the human lung. The MPPD modelling and animal data underscore this point vividly considering the relative amounts of inhaled particles that is predicted to be ultimately deposited in the alveolar regions of the lung and which is likely to become bioavailable versus that which can be applied by means of direct oral application at a limit dose of 1000 mg/kg bw/d. In light of this, it becomes evident that the potential to maximize the internal dose is higher via the oral than the inhalation route. This is consistent with the recommendations of ECHA guidance R7a which considers the oral route as the default route for repeated dose toxicity testing because it is assumed to maximise systemic availability (internal dose) for most substances (ECHA R7a). In the available oral study, doses up to the limit dose for the oral route of exposure i.e. at 1000 mg/kg bw were employed. It can be argued therefore that at an external dose of this magnitude, the level of systemic exposure would have been maximised. The study is thus robust enough to provide adequate information on the potential effects of carbon black on systemic organs. Weighted together, the available studies via the oral- and inhalation route provide adequate STOT information on carbon black - with acceptable restrictions. Quality-wise, this information is comparable or equivalent to the kind that can be generated from an OECD Guideline 413 (90-Day (Sub-chronic) Inhalation Toxicity Study (version of 9 October 2017). Against this background, it is concluded that available information allows to conclude on the endpoint of repeated dose toxicity (STOT) as regards hazard identification and classification.    Reference: Southam DS, Dolovich M, O’Byrne PM and Inman MD. Distribution of intranasal instillations in mice:effects of volume, time, body position, and anesthesia. Am J Physiol Lung Cell Mol Physiol 282: L833–L839, 2002 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a2b2e46-6d75-4bbb-9e1d-c810ffdcd205/documents/IUC5-97ddf850-c08f-44d5-8d42-fd5b181f8a14_ddb784a0-edf9-4989-8681-fdb8c8350357.html,,,,,, Carbon black,1333-86-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a2b2e46-6d75-4bbb-9e1d-c810ffdcd205/documents/IUC5-97ddf850-c08f-44d5-8d42-fd5b181f8a14_ddb784a0-edf9-4989-8681-fdb8c8350357.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1 mg/m3,adverse effect observed,rat Carbon black,1333-86-4," Oral exposure: No acute toxicity via the oral route is not expected for untreated nanoforms of carbon black. The acute oral toxicity of untreated nanoforms of carbon black is very low; no clinical signs of toxicity were noted in rats treated by gavage with the maximum technically achievable dose (8,000 -10,000 mg/kg bw). Inhalation exposure: The weight-of-evidence does not indicate the potential of an acute inhalation hazard. A 5-day high-quality GLP repeated dose inhalation toxicity study by Ma-Hock et al. (2013) revealed no effects in rats at 10 mg/m3 (6h/d, 5d/wk). The MMAD in this study was in the submicron range (0.6 μm); the primary structure of the material was in the 50 - 100 nm range. There were no clinical effects, nor any changes found at necropsy, in haematology, acute phase proteins, histology (only the lung was investigated), or BAL fluid. Another well-reported and high-quality study by Vincent et al. (2001) showed no adverse effects in rats exposed for 4 hours to 4.6 mg/m3 of a non-nanoform of carbon black. In another study, Pauluhn et al 2009, exposed male rats to 229 mg/m3 Printex 90 carbon black (solid: nanoform, no surface treatment) for 6 hours (nose only) MMAD 2 µm; GSD 2.2. The animals tolerated the exposure well in this study. Kang et al 2013 reported no mortality in male Sprague-Dawley rats which were exposed to Printex 90 carbon black aerosols for 6 hours/day for 3 days or for 2 weeks. The median mass aerodynamic diameter of carbon black aerosols averaged 2.08 µm (for aerosol prepared without sonication; group N) and 1.79 µm (for aerosol prepared without sonication; group S). The average concentration of carbon black during the exposure period for group N and group S was 13.08 ± 3.18 mg/m3 and 13.67 ± 3.54 mg/ m3, respectively, in the 3-day experiment. The average concentration during the 2-week experiment was 9.83 ± 3.42 mg/m3 and 9.08 ± 4.49 mg/m3 for group N and group S, respectively. Further, it has been documented that at regulatory relevant concentrations as required in the conventional acute inhalation studies (up to 5 mg/L), dry powder aerosols of poorly soluble substances like carbon black tend to form conglomerates causing physical obstruction of the animals’ airways and impaired respiration and suffocation (Hoffman et al 2018). Death caused via this mode of action should not be misdiagnosed as toxic effect (see also OECD Guidance #39 on Inhalation Toxicity Studies 2018, section 69,). Reference: Thomas Hofmann, Lan Ma-Hock, Wera Teubner, Jasmin-Chasmina Athas, Nicole Neubauer, Wendel Wohlleben, Ulrich Veith, Nicole End, Sibylle Groeters, Bennard van Ravenzwaay and Robert Landsiedel. 2018. Reduction of Acute Inhalation Toxicity Testing in Rats: The Contact Angle of Organic Pigments Predicts Their Suffocation Potential APPLIED IN VITRO TOXICOLOGY Volume 4, Number 2, 2018 Dermal exposure: An acute dermal toxicity study does not need to be performed because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo skin irritation and skin sensitisation studies. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a2b2e46-6d75-4bbb-9e1d-c810ffdcd205/documents/e1d4b326-fcfb-461c-a07e-075c5facd5c3_ddb784a0-edf9-4989-8681-fdb8c8350357.html,,,,,, Chromium (III) oxide,1308-38-9," No chronic repeated dose toxicity study with dichromium trioxide is available. However, based on the information available from two chronic repeated dose oral toxicity studies conducted with chromium picolinate monohydrate using male and female F344/N rats and B6C3F1 mice, it was concluded using a read-across concept that dichromium trioxide does not present a health hazard to either sex. This finding is supported by a sub-chronic oral repeated dose toxicity study with dichromium trioxide. No adverse effects could be observed in none of these studies after the administration of chromium picolinate monohydrate and dichromium trioxide, respectively. The approach for read-across is described in detail in the document attached in IUCLID section 13. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67e335b6-cb1d-498c-ac18-28f483ed975c/documents/IUC5-abb1fc78-2bed-4042-91db-c3b905747f4b_8df39770-351f-4ee9-9510-1d99da19df07.html,,,,,, Chromium (III) oxide,1308-38-9, Acute oral toxicity: LD50 > 5000 mg/kg bw (equivalent or similar to OECD 401; GLP compliant) Acute inhalation toxiciy: LC50 > >5.41 mg/L (analytical; OECD 403; GLP compliant) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67e335b6-cb1d-498c-ac18-28f483ed975c/documents/IUC5-f04d5198-1301-47a6-9d73-cf62891b4b1c_8df39770-351f-4ee9-9510-1d99da19df07.html,,,,,, Chromium (III) hydroxide,1308-14-1," Regardless of the high Cr3+ doses, chromium(III) oxide did not cause any significant treatment-related changes in the general condition of animals, body weights, clinical biochemistry, haematology, or pathological examination. The lack of toxicity of chromium(III) oxide can be explained by the poor bioavailability of this water-insoluble chromium compound. Faeces of treated animals showed an intense green discoloration, indicating significant excretion of the substance into faeces. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dd4da5b-ed70-4ca5-b939-3eedad9ee439/documents/13a6155c-828e-4014-888c-f9dd93a43ed3_692fad89-1e6a-4c97-ba4a-6be326f1bf9d.html,,,,,, Chromium (III) hydroxide,1308-14-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dd4da5b-ed70-4ca5-b939-3eedad9ee439/documents/13a6155c-828e-4014-888c-f9dd93a43ed3_692fad89-1e6a-4c97-ba4a-6be326f1bf9d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat Chromium (III) hydroxide,1308-14-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dd4da5b-ed70-4ca5-b939-3eedad9ee439/documents/13a6155c-828e-4014-888c-f9dd93a43ed3_692fad89-1e6a-4c97-ba4a-6be326f1bf9d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"44,000 mg/m3",,rat Chromium (III) hydroxide,1308-14-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dd4da5b-ed70-4ca5-b939-3eedad9ee439/documents/13a6155c-828e-4014-888c-f9dd93a43ed3_692fad89-1e6a-4c97-ba4a-6be326f1bf9d.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"44,000 mg/m3",no adverse effect observed,rat Chromium (III) hydroxide,1308-14-1," From extensive work on chromium III salts, there is no evidence of acute toxicity. Some corrosive salts will cause harm at high concentrations, but this is not considered to be a toxic effect. In view of the wealth of data on chromium salts, no further animal testing is justifed. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dd4da5b-ed70-4ca5-b939-3eedad9ee439/documents/32e63340-7c12-4c93-a7cb-a20fd8a741ac_692fad89-1e6a-4c97-ba4a-6be326f1bf9d.html,,,,,, Chromium (III) hydroxide,1308-14-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dd4da5b-ed70-4ca5-b939-3eedad9ee439/documents/32e63340-7c12-4c93-a7cb-a20fd8a741ac_692fad89-1e6a-4c97-ba4a-6be326f1bf9d.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Cobalt aluminate blue spinel,1345-16-0,"Sub-acute oral toxicity 28 -day repeated dose toxicity studies were conducted in rats as a limit test to assess the effect of the analogue pigment cobalt zinc aluminate blue spinel in rats following repeated oral administration. The study was performed according to OECD test guideline 407 and in compliance with GLP. No signs of toxicity were observed in rats when administered at a dose of 1000 mg/kg bw/day for up to 28 days. Consequently, the no observed adverse effect level (NOAEL) in rats is 1000 mg/kg/day. Sub-chronic inhalation toxicity A 90 -day repeated dose inhalation toxicity study with the analogue pigment cobalt zinc aluminate blue spinel is available. The study was performed according to OECD test guideline 413 and in compliance with GLP. No signs of local or systemic toxicity up to the maximum tolerated concentration were reported in the study record of the source substance. The highest concentrations in the study caused a more than 2-fold increase of the lung clearance half time, indicating for an overload of particle clearance (hence exceeting the maximum tolerated concentration). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a651127-d7d2-4490-957a-c4c66616610a/documents/e767e2a4-a403-42ea-b5f0-82600d8f464f_f2836770-18eb-4212-ae54-f1defa43486a.html,,,,,, Cobalt aluminate blue spinel,1345-16-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a651127-d7d2-4490-957a-c4c66616610a/documents/e767e2a4-a403-42ea-b5f0-82600d8f464f_f2836770-18eb-4212-ae54-f1defa43486a.html,Repeated dose toxicity – local effects,inhalation,NOAEC,6 mg/m3,no adverse effect observed,rat Cobalt aluminate blue spinel,1345-16-0, Acute oral toxicity: LD50 > 10000 mg/kg bw (OECD 401 (1987); non-GLP compliant) Acute inhalation toxicity: LC50 (rats; 4 hours) > 5.06 mg/L air (actual concentration) (OECD 436 (2009); GLP compliant)(read across to cobalt zinc aluminate blue spinel) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a651127-d7d2-4490-957a-c4c66616610a/documents/IUC5-4de87ef5-76ac-4980-905a-720599bfd5d1_f2836770-18eb-4212-ae54-f1defa43486a.html,,,,,, Copper,7440-50-8,"ORAL : The pivotal repeat dose study was a 90-day study by the oral route with copper sulphate pentahydrate. In rats and mice, ingestion of copper sulphate pentahydrate produced forestomach lesions that could be to the irritant effects of the compound. The NOAEL for this effect was 16.7 mg Cu/kg bw/day in rats and 97 and 126 mg Cu/kg bw/day in male and female mice respectively. In rats inflammation of the liver was observed. The NOAEL’s for liver and kidney damage were 16.7 mg Cu/kg bw/day in rats. This is the pivotal study and the NOAEL of 16.7 mg Cu/kg bw/day will be used in the risk characterisation. INHALATION : the pivotal study in the 28 days rat inhalation study on Cu2O. The main conclusion is observed effects at all doses (0.2-2 mg/m3) but no adverse effects at the highest dose tested (2 mg/m3). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/769a3561-67ad-491f-9696-f2addc049add/documents/IUC5-eb2e38e0-87b7-4dd7-84c1-372bd81c5883_50f830c2-19e3-4a12-ac36-5d2d9f515eaf.html,,,,,, Copper,7440-50-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/769a3561-67ad-491f-9696-f2addc049add/documents/IUC5-eb2e38e0-87b7-4dd7-84c1-372bd81c5883_50f830c2-19e3-4a12-ac36-5d2d9f515eaf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat Copper,7440-50-8,"Several high quality criteria studies (reliability 1 or 2) on coated copper flakes and several copper compounds are available from the VRA. These have been evaluated by the Competent authorities for Existing Substances and Biocides. Some additional studies (reliability 1-3) on “coated copper flakes” were submitted thereafter and have been discussed in more details in the chemical safety report (section 5.2.1.2 and section 5.2.3). Only high quality criteria (reliability 1 or 2) studies relevant to the hazard assessment of coated copper flakes and copper (powder and massive forms) were retained for the CSR. The VRA provides additional, lower quality studies as well as studies specific to other soluble copper compounds. If not pivotal to this copper REACH dossier, they are described in the copper VRA but not further discussed below.For the hazard profile of copper powder, information on solubility, bioavailability and bioaccessibility (sections 5.1) are combined with the hazard profile of copper compounds and coated copper flakes in a read-across approach to assess its potential hazards . ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/769a3561-67ad-491f-9696-f2addc049add/documents/IUC5-de0755d3-c748-4f60-8366-6c0f05e761f8_50f830c2-19e3-4a12-ac36-5d2d9f515eaf.html,,,,,, Copper,7440-50-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/769a3561-67ad-491f-9696-f2addc049add/documents/IUC5-de0755d3-c748-4f60-8366-6c0f05e761f8_50f830c2-19e3-4a12-ac36-5d2d9f515eaf.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Copper,7440-50-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/769a3561-67ad-491f-9696-f2addc049add/documents/IUC5-de0755d3-c748-4f60-8366-6c0f05e761f8_50f830c2-19e3-4a12-ac36-5d2d9f515eaf.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Copper,7440-50-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/769a3561-67ad-491f-9696-f2addc049add/documents/IUC5-de0755d3-c748-4f60-8366-6c0f05e761f8_50f830c2-19e3-4a12-ac36-5d2d9f515eaf.html,,inhalation,LC50,"5,110 mg/m3",adverse effect observed, Triiron tetraoxide,1317-61-9,"A subacute inhalation toxicity study for Fe3O4, Fe2O3 and FeOOH and a subchronic inhalation study for Fe3O4 are available. Additionally, a short-term (5-day) inhalation study with two different grades of nanomaterials was conducted. Rats were exposed to 10 and 30 mg/m³ of smaller nano-sized Fe2O3 and 30 mg/m³ of larger nano-sized Fe2O3. Based on the information from a 90-day repeated dose oral toxicity study in rats (according to OECD 408, GLP) it is concluded that the Fe3O4 does not show any adverse effects up to the highest dose level of 1000 m/kg bw/day. For dermal toxicity no reliable repeated dose toxicity studies are available for the iron oxide category. Details on the category justification are given in the read-across document attached in IUCLID section 13.2. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4e0981a-644c-4538-9f05-070dd6a58493/documents/IUC5-d834a075-9cc9-4556-9cd5-9dd886d07d08_fde3e620-12d5-4e55-8b25-f802ef54c4ab.html,,,,,, Triiron tetraoxide,1317-61-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4e0981a-644c-4538-9f05-070dd6a58493/documents/IUC5-d834a075-9cc9-4556-9cd5-9dd886d07d08_fde3e620-12d5-4e55-8b25-f802ef54c4ab.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4.7 mg/m3,no adverse effect observed,rat Triiron tetraoxide,1317-61-9,Two reliable studies for oral toxicity were evaluated. In an acute inhalation toxicity study rats were exposed to a concentration of 640mg/m³ (maximum attainable concentration) Fe3O4 nanoparticles. None of the animals died. In an additional acute inhalation toxicity study with Fe2O3 as a surrogate for the iron oxide group the discriminating dose was 5050 mg/m³. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4e0981a-644c-4538-9f05-070dd6a58493/documents/IUC5-4e0b141e-ba69-4bc2-a4a2-dbaed50ff5ad_fde3e620-12d5-4e55-8b25-f802ef54c4ab.html,,,,,, Triiron tetraoxide,1317-61-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4e0981a-644c-4538-9f05-070dd6a58493/documents/IUC5-4e0b141e-ba69-4bc2-a4a2-dbaed50ff5ad_fde3e620-12d5-4e55-8b25-f802ef54c4ab.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Triiron tetraoxide,1317-61-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4e0981a-644c-4538-9f05-070dd6a58493/documents/IUC5-4e0b141e-ba69-4bc2-a4a2-dbaed50ff5ad_fde3e620-12d5-4e55-8b25-f802ef54c4ab.html,,inhalation,discriminating conc.,640 mg/m3,adverse effect observed, Iron hydroxide oxide yellow,51274-00-1,"A subacute inhalation toxicity study for Fe3O4, Fe2O3 and FeOOH and a subchronic inhalation studyfor Fe3O4 are available. Based on the information from a 90-day repeated dose oral toxicity study in rats (according to OECD 408, GLP) it is concluded that iron hydroxide oxide yellow does not show any adverse effects up to the highest dose level of 1000 m/kg bw/day. For dermal toxicity no reliable repeated dose toxicity studies are available for the iron oxide category. Details on the category justification are given in the read-across document attached in IUCLID section 13.2. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/deacb9de-7495-49d7-84da-81b71f161a05/documents/IUC5-9527a689-c295-4b09-b15a-248a9f276923_b6e6a5d9-70dc-4cb1-bbd9-81391f49131b.html,,,,,, Iron hydroxide oxide yellow,51274-00-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/deacb9de-7495-49d7-84da-81b71f161a05/documents/IUC5-9527a689-c295-4b09-b15a-248a9f276923_b6e6a5d9-70dc-4cb1-bbd9-81391f49131b.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4.7 mg/m3,adverse effect observed,rat Iron hydroxide oxide yellow,51274-00-1,In an oral acute toxicity study 10 animals were treated with 10000 mg/kg bw FeOOH. During an observation time of 14 days none of the animals showed signs of toxicity or died. In an acute inhalation toxicity study with Fe2O3 as a surrogate for the iron oxide group the discriminating dose was 5050 mg/m³. No study for acute dermal toxicity is available. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/deacb9de-7495-49d7-84da-81b71f161a05/documents/IUC5-85bd576d-2919-431f-9f42-46eeb6e8e9c3_b6e6a5d9-70dc-4cb1-bbd9-81391f49131b.html,,,,,, Iron hydroxide oxide yellow,51274-00-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/deacb9de-7495-49d7-84da-81b71f161a05/documents/IUC5-85bd576d-2919-431f-9f42-46eeb6e8e9c3_b6e6a5d9-70dc-4cb1-bbd9-81391f49131b.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, Iron hydroxide oxide yellow,51274-00-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/deacb9de-7495-49d7-84da-81b71f161a05/documents/IUC5-85bd576d-2919-431f-9f42-46eeb6e8e9c3_b6e6a5d9-70dc-4cb1-bbd9-81391f49131b.html,,inhalation,discriminating conc.,"5,050 mg/m3",no adverse effect observed, Ammonium iron(3+) hexakis(cyano-C)ferrate(4-),25869-00-5,"oral:Based on a weight of eveidence approach and based on the available read-across data, there is no evidence that Ammonium iron (3+) hexakis (cyano-C) ferrate (4- ) causes any adverse effects after repeated administration of doses up to 2500 mg/kg bw/d.dermal:no data are available for dermal repeated dose toxicity.inhalation:no data are available for repeated dose toxicity after inhalation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ae5e289c-816b-403f-8031-3053b9e09f78/documents/IUC5-5565797f-0976-4b18-8601-9cbcd1574f06_73ad456d-1d84-4126-922e-ba745458c1b8.html,,,,,, Ammonium iron(3+) hexakis(cyano-C)ferrate(4-),25869-00-5,"Oral (OECD 423), rat: LD50 = 5000 mg/kg bw (cut-off limit)Dermal (OECD 402), rat: LD50 > 2000 mg/kg bwNo acute inhalation toxicity studies are available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae5e289c-816b-403f-8031-3053b9e09f78/documents/IUC5-b375e5ba-2fbe-4b77-9e4a-c98504c45810_73ad456d-1d84-4126-922e-ba745458c1b8.html,,,,,, Magnesium carbonate,546-93-0,"Repeat dose oral toxicity: A 28-day and a 90-day repeat dose oral toxicity study in rats are available that have evaluated the repeated dose toxicity of magnesium chloride hexahydrate. These results are directly applicable to magnesium carbonate. A 13-week study in the mouse and a number of human studies are also available. No severe or adverse toxicological effects were reported following oral administration of the test material for 28 days. The main effects observed in the 90-day study in rats and some of the long-term human studies were transient soft stools and diarrhoea. Based on the human data, the EC SCF has concluded a NOAEL equivalent to 14.5 mg MgCO3/kg bw/day.Repeat dose dermal toxicity: No studies on the repeated dose dermal toxicity of magnesium carbonate are available.Repeat dose inhalation toxicity: No studies on the repeated dose inhalation toxicity of magnesium carbonate are available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8547868-addf-4986-8a0f-bcb05aed9be8/documents/IUC5-5ef9f891-04d7-43d2-a859-4d37f078aa6c_28aa68dd-176a-44ba-8871-a53cd67d51b4.html,,,,,, Magnesium carbonate,546-93-0,Magnesium carbonate is not considered to be acutely harmful by the oral route. Testing via the dermal and inhalation routes is not required or scientifically justified. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8547868-addf-4986-8a0f-bcb05aed9be8/documents/IUC5-783755b8-b568-42cb-aa69-0111707c2902_28aa68dd-176a-44ba-8871-a53cd67d51b4.html,,,,,, Trimanganese bis(orthophosphate),14154-09-7,"Acute oral toxicity: One key study is available, the study was performed on the registered substance in accordance with the relevant OECD test guideline and under the conditions of GLP. Acute inhalation toxicity: One key study is available, the study was performed on the registered substance in accordance with the relevant OECD test guideline and under the conditions of GLP. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5fd80a8-b345-442f-8059-e6d468320781/documents/6323d6e3-079b-481b-9018-6c6bd9e260d9_6c8f5736-99a7-4eb5-8c26-6b6685a1d9ef.html,,,,,, Trimanganese bis(orthophosphate),14154-09-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5fd80a8-b345-442f-8059-e6d468320781/documents/6323d6e3-079b-481b-9018-6c6bd9e260d9_6c8f5736-99a7-4eb5-8c26-6b6685a1d9ef.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Trimanganese bis(orthophosphate),14154-09-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5fd80a8-b345-442f-8059-e6d468320781/documents/6323d6e3-079b-481b-9018-6c6bd9e260d9_6c8f5736-99a7-4eb5-8c26-6b6685a1d9ef.html,,inhalation,LC50,> 5.07 mg/L,no adverse effect observed, Silver,7440-22-4,"Silver metal massive and powder:Oral: no adverse effects via repeated exposure via oral route is expected for silver (massive and powder).Inhalation: a strong weight of evidence using the available data demonstrates that adverse effects via repeatedexposure via inhalation route are not expected for silver metal (massive and powder). The repeated dose inhalationtoxicity studies performed with nanosilver only identified adverse local effects and inflammation, which in certainis reversible but any case considered relevant for nanoparticles only. There is no systemic / local effect expected viarepeated exposure to silver metal (massive and powder) inhalation route.Dermal: route considered to be less relevantFor further information, please refer to section 13 documents ""CSR Annex 11 - Weight of Evidence Justification for Silver metal - human health endpoints. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b43d6b46-c045-45c9-9cff-f7f664e55bec/documents/IUC5-26dd4b13-33ec-4e7d-87f3-c4d76725b55b_1bb13f1a-69ec-46a9-96cf-50f2310fc909.html,,,,,, Silver,7440-22-4,"Reliable experimental studies in animals indicate a low acute toxicity of elemental silver (including nanoforms), following exposure via the oral, dermal or inhalation route. No mortality or any relevant clinical signs of acute toxicity were observed and the following effect levels were established for silver as follows: LD50oral > 5000 mg/kg, LD50dermal > 2000 mg/kg and LC50inhalation > 5.16 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b43d6b46-c045-45c9-9cff-f7f664e55bec/documents/IUC5-bed8a489-9562-46f1-b679-0a5aef803b91_1bb13f1a-69ec-46a9-96cf-50f2310fc909.html,,,,,, Titanium dioxide,13463-67-7,"Titanium dioxide did not show any adverse effects in 90-day and 28-day oral repeated dose toxicity studies in rats with a NOAEL of 1000 and 24,000 mg/kg bw/day, respectively. No adverse effects were observed in rats and mice orally exposed up to a dose of 3500 mg/kg bw/day over a period of 103 weeks in a carcinogenicity bioassay. Titanium dioxide is not absorbed to any relevant extent through human skin, thus no toxic effects can be expected via the dermal route of exposure. Titanium dioxide showed adverse pulmonary effects in chronic inhalation studies only at concentrations above the maximum tolerated dose (MTD).   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c5c11b0-f180-47e0-ac54-a198dbda9db1/documents/6df3d3bb-4af8-4286-9441-b491067f38fd_387df676-a807-44df-9fa3-383d8179d9a6.html,,,,,, Titanium dioxide,13463-67-7,"Acute toxicity, oral: LD50 > 5000 mg/kg bw Acute toxicity, inhalation: LC50 > 6.82 mg/L (MMAD=1.55 µm, GSD=1.70 µm) Acute toxicity, dermal: Conduct of an acute dermal toxicity study is unjustified as inhalation of the substance is considered as major route of exposure and physicochemical properties and dermal absorption data of the substance do not suggest a significant rate of absorption through the skin (cf. Annex VIII section 8.5 Column 2 of Regulation (EC) 1907/2006). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c5c11b0-f180-47e0-ac54-a198dbda9db1/documents/f2dd5f98-7968-4774-be6f-8aaf952a7eb6_387df676-a807-44df-9fa3-383d8179d9a6.html,,,,,, Zinc oxide,1314-13-2,"Animal data Oral: The repeated dose toxicity of the zinc category substances has been examined in a number of sub-chronic oral repeated dose toxictiy studies. The NOAEL for systemic effects of the zinc category substances was determined to be 25 mg Zn/kg bw/day, derived in an oral 90-day study with nano zinc oxide in rats. Inhalation: The repeated dose inhalation toxicity of micro and nano-ZnO has been examined respectively in a subacute (28 days) and two subchronic (90 days) inhalation studies. The lowest NOAEC was determined to be 0.47 mg/m³ (target concentration: 0.5 mg/m³) for micro ZnO. For nano-ZnO the BMCL10 was determined to be 0.971 mg/m³. Dermal: No adverse effects were observed in a 90-day repeated dose toxicity study via the dermal route with nano-ZnO. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): guideline studies available ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab1ed875-06ec-4db4-b59e-e52324caa7fa/documents/b00a2b30-def8-4a44-846f-f05da27ce99a_bc7bd01a-fd67-47d1-b116-fc4c9d4d5fab.html,,,,,, Zinc oxide,1314-13-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab1ed875-06ec-4db4-b59e-e52324caa7fa/documents/b00a2b30-def8-4a44-846f-f05da27ce99a_bc7bd01a-fd67-47d1-b116-fc4c9d4d5fab.html,Repeated dose toxicity – local effects,inhalation,BMCL10,0.971 mg/m3,adverse effect observed,rat Zinc oxide,1314-13-2,Acute oral toxicity: key studies carried out according to OECD guideline no 401 or 423 indicating for both micro- and nanomaterial zinc oxide LD50 > 2000 mg/kg bw Acute inhalation toxicity: key study carried out according to OECD guideline no 403 indicating for micro zinc oxide LC50 > 5.7 mg/L/4hrs. Acute dermal toxicity: key study carried out according to OECD guideline no 402 indicating for nano zinc oxide LD50 >2000 mg/kg bw.     ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab1ed875-06ec-4db4-b59e-e52324caa7fa/documents/IUC5-2acb568b-3545-4ff9-8f59-07ca6d853295_bc7bd01a-fd67-47d1-b116-fc4c9d4d5fab.html,,,,,, Zinc oxide,1314-13-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab1ed875-06ec-4db4-b59e-e52324caa7fa/documents/IUC5-2acb568b-3545-4ff9-8f59-07ca6d853295_bc7bd01a-fd67-47d1-b116-fc4c9d4d5fab.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Zinc oxide,1314-13-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab1ed875-06ec-4db4-b59e-e52324caa7fa/documents/IUC5-2acb568b-3545-4ff9-8f59-07ca6d853295_bc7bd01a-fd67-47d1-b116-fc4c9d4d5fab.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Zinc oxide,1314-13-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab1ed875-06ec-4db4-b59e-e52324caa7fa/documents/IUC5-2acb568b-3545-4ff9-8f59-07ca6d853295_bc7bd01a-fd67-47d1-b116-fc4c9d4d5fab.html,,inhalation,LC50,"5,700 mg/m3",no adverse effect observed, Cinnamaldehyde,104-55-2," Repeated dose toxicity: Oral The purpose of the study was to examine the relative toxicity of the test chemical in B6C3F1 mice when administered in corn oil by gavage. The test chemical was administered on a daily basis at dose concentration of 0, 656, 1310, 2620, 5250 or 10500 mg/kg/day for 14 days. No statistically significant differences in body weight, liver weight, spleen weight and kidney weight was observed. In addition, no statistically significant differences in organ:body weight ratios between surviving treated mice and control mice was observed. All mice from two highest dose group as well as all female mice and three male mice from the 656 mg/kg/day dose group died within the first 2 days of dosing. No clinical signs or gross lesions were observed in surviving mice and dead mice. Only a minimal to mild forestomach hyperplasia in both sexes and a minimal kidney nephropathy at doses of 1310 mg/kg/day and higher was shown. Hence, the no observed adverse effect level (NOAEL) of the test chemical was considered to be 656 mg/kg/day inB6C3F1 mice. The low observed adverse effect level (LOAEL) of the test chemical was considered to be 1310 mg/kg/day in B6C3F1 mice. Repeated dose toxicity: Inhalation The test chemical has very low vapor pressure (0.0289 mmHg at 25˚C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver.   Repeated dose toxicity: Dermal Repeated dose toxicity LOAEL (Lowest observed adverse effect level) of the test chemical to mouse by the dermal route was estimated at a dose concentration of 750 mg/kg bw/day. On the basis of this LOAEL value it is concluded that the test chemical was not toxic to rat by dermal route below the above mentioned dose. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf74e1b2-0fad-4778-850b-71d7293db50a/documents/67670d3b-c993-43dc-86ed-ac23a7166742_5de36bd2-ddd8-49c2-bc7a-a20252ea4f30.html,,,,,, Cinnamaldehyde,104-55-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf74e1b2-0fad-4778-850b-71d7293db50a/documents/67670d3b-c993-43dc-86ed-ac23a7166742_5de36bd2-ddd8-49c2-bc7a-a20252ea4f30.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,656 mg/kg bw/day,,mouse Cinnamaldehyde,104-55-2," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats, mice and guinea pigs for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.   Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0289 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: Based on all the available data, it was concluded that the test chemical was not toxic when applied dermally to the test animals. Thus, from all the observations and results, the LD50 of the test chemical was observed to be >2000 mg/kg bw, and is not classified as per the CLP criteria of classification and labelling. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf74e1b2-0fad-4778-850b-71d7293db50a/documents/74e48ba2-42d9-40d2-96a3-fd33246deb45_5de36bd2-ddd8-49c2-bc7a-a20252ea4f30.html,,,,,, Cinnamaldehyde,104-55-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf74e1b2-0fad-4778-850b-71d7293db50a/documents/74e48ba2-42d9-40d2-96a3-fd33246deb45_5de36bd2-ddd8-49c2-bc7a-a20252ea4f30.html,,oral,LD50,"3,400 mg/kg bw",no adverse effect observed, Cinnamaldehyde,104-55-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf74e1b2-0fad-4778-850b-71d7293db50a/documents/74e48ba2-42d9-40d2-96a3-fd33246deb45_5de36bd2-ddd8-49c2-bc7a-a20252ea4f30.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Camphor tree, ext.",92201-50-8,"Acute toxicity, oral: LD50 = 5100 mg/kg bw (K, Rel.2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55caeebf-c7e0-46a5-a16d-7335d8443f42/documents/IUC5-9d45f84c-1b8a-4a00-b51e-0fed1874e8a5_be50ef88-45f9-46c0-9e5d-7771251c7cf9.html,,,,,, "Camphor tree, ext.",92201-50-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55caeebf-c7e0-46a5-a16d-7335d8443f42/documents/IUC5-9d45f84c-1b8a-4a00-b51e-0fed1874e8a5_be50ef88-45f9-46c0-9e5d-7771251c7cf9.html,,oral,LD50,"5,100 mg/kg bw",no adverse effect observed, "Cinnamomum cassia, ext.",84961-46-6,Acute oral toxicity: LD50>2000 mg/kg bw (similar to OECD 420)Acute dermal toxicity: LD50=332 mg/kg bw (similar to OECD 402) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5597d78-c946-47ed-9363-853215ffb2ed/documents/52b53e8c-9dc7-4e29-aa5a-30da64c758c7_05722c0b-2bad-434d-b879-45c7a9a1a754.html,,,,,, "Cinnamomum cassia, ext.",84961-46-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5597d78-c946-47ed-9363-853215ffb2ed/documents/52b53e8c-9dc7-4e29-aa5a-30da64c758c7_05722c0b-2bad-434d-b879-45c7a9a1a754.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "Cinnamomum cassia, ext.",84961-46-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5597d78-c946-47ed-9363-853215ffb2ed/documents/52b53e8c-9dc7-4e29-aa5a-30da64c758c7_05722c0b-2bad-434d-b879-45c7a9a1a754.html,,dermal,LD50,332 mg/kg bw,adverse effect observed, "Cinnamomum zeylanicum, ext.",84649-98-9,Acute oral toxicity: LD50 2650 mg/kg bw (standard acute method) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78d78786-2dd9-4dd7-8c56-0a5ccc403762/documents/IUC5-462f447d-2097-4f92-8216-bf41d4daa02d_b029720a-4062-4644-ac9e-dbb6465b226e.html,,,,,, "Cinnamomum zeylanicum, ext.",84649-98-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78d78786-2dd9-4dd7-8c56-0a5ccc403762/documents/IUC5-462f447d-2097-4f92-8216-bf41d4daa02d_b029720a-4062-4644-ac9e-dbb6465b226e.html,,oral,LD50,"2,650 mg/kg bw",, Cinnamonitrile,1885-38-7," Acute oral toxicity The LD50 was estimated to be 275.34 mg/kg bw,when female Wistar rats were orally exposed with Cinnamyl nitrile (1885-38-7) via gavage. Acute dermal toxicity The LD50 value was estimated to be 1059.79 mg/kg bw,when male and female New Zealand White rabbits were exposed occlusively with Cinnamyl nitrile (1885-38-7) by dermal application for 24 hours. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c9add75-0380-4d94-9609-4715258a2ee6/documents/e02a6a4e-9274-4e02-ac87-a12574abe9e9_c931cf36-44fd-41b3-959c-bf26f926f7c4.html,,,,,, Cinnamonitrile,1885-38-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c9add75-0380-4d94-9609-4715258a2ee6/documents/e02a6a4e-9274-4e02-ac87-a12574abe9e9_c931cf36-44fd-41b3-959c-bf26f926f7c4.html,,oral,LD50,275.34 mg/kg bw,adverse effect observed, Cinnamonitrile,1885-38-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c9add75-0380-4d94-9609-4715258a2ee6/documents/e02a6a4e-9274-4e02-ac87-a12574abe9e9_c931cf36-44fd-41b3-959c-bf26f926f7c4.html,,dermal,LD50,"1,059.79 mg/kg bw",adverse effect observed, Cinnamyl acetate,103-54-8, The NOAEL for systemic toxicity in rats is considered to be > 600 mg/kg bw/day as there were no adverse effects observed in any parameters up to the highest dose tested. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d56fee5c-16ca-47f8-9b35-02b7546c3aa3/documents/2cd8822b-a62d-42c6-a4ac-d373966d8a28_bbb98478-8897-41b0-bde4-425ebc56bb30.html,,,,,, Cinnamyl acetate,103-54-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d56fee5c-16ca-47f8-9b35-02b7546c3aa3/documents/2cd8822b-a62d-42c6-a4ac-d373966d8a28_bbb98478-8897-41b0-bde4-425ebc56bb30.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat Cinnamyl acetate,103-54-8," Two acute oral toxicity studies have been performed, one key study and one supporting study performed on three species. None were following a guideline nor performed under GLP. All results yielded high LD50 values > 3000 mg/kg bw. One acute dermal toxicity study is available, in which no mortality was observed upon administration of a dermal dose (5000 mg/kg bw) of the test item. The acute oral and dermal studies are taken together in a weight of evidence approach. The available data show that the substance does not exert acute toxicity, irrespective of the administration route. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d56fee5c-16ca-47f8-9b35-02b7546c3aa3/documents/1c6a17f9-c59b-48bd-b181-cca8cbd02408_bbb98478-8897-41b0-bde4-425ebc56bb30.html,,,,,, Cinnamyl acetate,103-54-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d56fee5c-16ca-47f8-9b35-02b7546c3aa3/documents/1c6a17f9-c59b-48bd-b181-cca8cbd02408_bbb98478-8897-41b0-bde4-425ebc56bb30.html,,oral,LD50,"3,300 mg/kg bw",adverse effect observed, Cinnamyl acetate,103-54-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d56fee5c-16ca-47f8-9b35-02b7546c3aa3/documents/1c6a17f9-c59b-48bd-b181-cca8cbd02408_bbb98478-8897-41b0-bde4-425ebc56bb30.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Cinnamyl alcohol,104-54-1,"Repeated dose toxicity: oral - OECD 407 (2008) study: NOAEL for the substance (rats; oral gavage) was considered at 1000 mg/kg bw/day in both sexes. - Sub-chronic (90-days) toxicity study: NOAEL for the structural analogue (rats; exposure by diet) was considered at 4100 ppm in both sexes (about 275 mg/kg bw/day in males and 300 mg/kg bw/day in females) based on observed forestomach lesions at 8200 ppm and higher. - Chronic (2-year) toxicity study: NOEL for the structural analogue (rats; exposure by diet) was considered at 1000 ppm in males (about 50 mg/kg bw/day in both sexes) and at 2100 ppm in females (about 100 mg/kg bw/day). At 2100 ppm in males and at 4100 ppm in females, significant changes in body weight and food intake were observed. Repeated Dose Toxicity: Inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the test chemical, which is reported as 0.00268 mm Hg. Also considering the particle size distribution of the substance, the majority of the particles were found to be in the size of 105.0 micrometer which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely. Therefore this study is considered for waiver.   Repeated Dose Toxicity: Dermal The acute toxicity value for the test chemical (as provided in section 7.2.3) is >5000 mg/kg body weight. Also, given the use of the chemical as flavour and fragrance agents; repeated exposure by the dermal route is unlikely. Thus, it is expected that the test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that the test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b265d2f-ee82-4b3d-808d-b4c030084f96/documents/a7c65b63-46c0-44c3-a140-4a9d541faed1_ad87fe32-da98-46dc-bd50-7632445cf768.html,,,,,, Cinnamyl alcohol,104-54-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b265d2f-ee82-4b3d-808d-b4c030084f96/documents/a7c65b63-46c0-44c3-a140-4a9d541faed1_ad87fe32-da98-46dc-bd50-7632445cf768.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Cinnamyl alcohol,104-54-1,"Acute oral toxicity:    The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats, mice and guinea pigs for the given test chemical. The LD50 value is 2000 mg/kg bw. The study concluded that the LD50 value is between >300 - ≤ 2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity.   Acute Inhalation Toxicity:   The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.024 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity:   The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b265d2f-ee82-4b3d-808d-b4c030084f96/documents/4842d9b5-f28b-40a6-802b-67e8f15da2b7_ad87fe32-da98-46dc-bd50-7632445cf768.html,,,,,, Cinnamyl alcohol,104-54-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b265d2f-ee82-4b3d-808d-b4c030084f96/documents/4842d9b5-f28b-40a6-802b-67e8f15da2b7_ad87fe32-da98-46dc-bd50-7632445cf768.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Cinnamyl alcohol,104-54-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b265d2f-ee82-4b3d-808d-b4c030084f96/documents/4842d9b5-f28b-40a6-802b-67e8f15da2b7_ad87fe32-da98-46dc-bd50-7632445cf768.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Cinnamyl formate,104-65-4," Acute Oral Toxicity: The lethal concentration (LD50) value for acute oral toxicity test was considered to be 2900 mg/kg bw(95% C.I. 2380–3540 mg/kg) ,when 50 rats were treated with Cinnamyl formate (104-65-4) orally. Acute Dermal Toxicity: The LD50 value was considered to be >5000 mg/kg bw,when 6 rabbits were treated occlusively with Cinnamyl formate (104-65-4) by dermal application for exposure of 24 hours. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9513b46e-4872-4719-906f-aed29b22d625/documents/bde9ca36-ebee-4148-8ba3-8075da6b30b3_7dcf8a15-d354-47fb-8152-a256288f1860.html,,,,,, Cinnamyl formate,104-65-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9513b46e-4872-4719-906f-aed29b22d625/documents/bde9ca36-ebee-4148-8ba3-8075da6b30b3_7dcf8a15-d354-47fb-8152-a256288f1860.html,,oral,LD50,"2,900 mg/kg bw",no adverse effect observed, Cinnamyl formate,104-65-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9513b46e-4872-4719-906f-aed29b22d625/documents/bde9ca36-ebee-4148-8ba3-8075da6b30b3_7dcf8a15-d354-47fb-8152-a256288f1860.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Cinnamyl propionate,103-56-0," Acute oral toxicity LD 50 was considered to be 3400 mg/kg, When rats were treated with Cinnamyl propionate (103-56-0) orally. Acute dermal toxicity The LD50 was considered to be >5000 mg/kg. When rabbits were treated with Cinnamyl propionate (103-56-0)by dermal application ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36a21dd3-95fc-420a-8a01-831134044245/documents/73a191e0-acb0-47dd-b89d-6e9725d71921_75bb8769-7559-42f4-aa1b-cac238c7f0bd.html,,,,,, Cinnamyl propionate,103-56-0,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36a21dd3-95fc-420a-8a01-831134044245/documents/73a191e0-acb0-47dd-b89d-6e9725d71921_75bb8769-7559-42f4-aa1b-cac238c7f0bd.html,,oral,LD50,"3,400 mg/kg bw",no adverse effect observed, Cinnamyl propionate,103-56-0,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36a21dd3-95fc-420a-8a01-831134044245/documents/73a191e0-acb0-47dd-b89d-6e9725d71921_75bb8769-7559-42f4-aa1b-cac238c7f0bd.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "cis-2-methyl-4-propyl-1,3-oxathiane",59323-76-1," Oral (gavage): NOAEL : ≥ 600 mg/kg bw/day, male/female, OECD TG 422, 2018 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3702b2e-9fcb-43ab-9296-fe0b2f58caa5/documents/40d72492-647a-4da8-b3b8-437165ef0366_986c1c24-efda-4e88-8d25-95f1e09c2115.html,,,,,, "cis-2-methyl-4-propyl-1,3-oxathiane",59323-76-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3702b2e-9fcb-43ab-9296-fe0b2f58caa5/documents/40d72492-647a-4da8-b3b8-437165ef0366_986c1c24-efda-4e88-8d25-95f1e09c2115.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat "cis-2-methyl-4-propyl-1,3-oxathiane",59323-76-1," Oral: measured LD50 > 2000 mg/kg bw, female rat, OECD TG 423, 2006 Inhalation: LC50 (male/female): > 4.87 mg/L, mean maximum achievable atmosphere concentration, male/female rat, OECD TG 436, 2018 Dermal: estimated LD50 > 2000 mg/kg bw based upon absence of systemic toxicity in oral and other relevant studies, applicant assessment 2018 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3702b2e-9fcb-43ab-9296-fe0b2f58caa5/documents/8e0d1588-310a-4cf5-9c20-ffbf5927e80f_986c1c24-efda-4e88-8d25-95f1e09c2115.html,,,,,, "cis-2-methyl-4-propyl-1,3-oxathiane",59323-76-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3702b2e-9fcb-43ab-9296-fe0b2f58caa5/documents/8e0d1588-310a-4cf5-9c20-ffbf5927e80f_986c1c24-efda-4e88-8d25-95f1e09c2115.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "cis-2-methyl-4-propyl-1,3-oxathiane",59323-76-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3702b2e-9fcb-43ab-9296-fe0b2f58caa5/documents/8e0d1588-310a-4cf5-9c20-ffbf5927e80f_986c1c24-efda-4e88-8d25-95f1e09c2115.html,,inhalation,LC50,"4,870 mg/m3",adverse effect observed, cis-2-tert-butylcyclohexan-1-ol,7214-18-8,"Acute oral toxicity (based on read across from Verdox after conversion for molecular weight difference ): LD50 = 3624 mg/kg bw Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The acute oral toxicity result is of sufficient quality and adequate for this dossier. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df80a750-ef79-4a40-98f9-a325b77eae5d/documents/d570305f-3303-4fc5-91a2-9bab8059c1a1_451cf680-f892-4bd9-8e47-4c778a49083f.html,,,,,, cis-2-tert-butylcyclohexan-1-ol,7214-18-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df80a750-ef79-4a40-98f9-a325b77eae5d/documents/d570305f-3303-4fc5-91a2-9bab8059c1a1_451cf680-f892-4bd9-8e47-4c778a49083f.html,,oral,LD50,"3,624 mg/kg bw",no adverse effect observed, "cis-3,5,5-trimethylcyclohexan-1-ol",933-48-2,Acute toxicity: oral: LD50 = 3250 mg/kg bw (WoE).Acute toxicity: dermal: LD50 = 2430 mg/kg bw ( WoE). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b64c7f89-4489-4c93-bafd-d1c93996bd27/documents/IUC5-4c02c21e-7dd5-4895-a6ad-f4bc098e2e30_a62a1c36-e4f2-43ea-aca3-77356020d4a9.html,,,,,, "cis-3,5,5-trimethylcyclohexan-1-ol",933-48-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b64c7f89-4489-4c93-bafd-d1c93996bd27/documents/IUC5-4c02c21e-7dd5-4895-a6ad-f4bc098e2e30_a62a1c36-e4f2-43ea-aca3-77356020d4a9.html,,oral,LD50,"3,250 mg/kg bw",adverse effect observed, "cis-3,5,5-trimethylcyclohexan-1-ol",933-48-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b64c7f89-4489-4c93-bafd-d1c93996bd27/documents/IUC5-4c02c21e-7dd5-4895-a6ad-f4bc098e2e30_a62a1c36-e4f2-43ea-aca3-77356020d4a9.html,,dermal,LD50,"2,430 mg/kg bw",adverse effect observed, (Z)-hex-3-enyl acetate,3681-71-8,"Repeat dose toxicity via the oral route: The NOAEL of the test material administered orally by gavage to Wistar rats, could be established at 1000 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/770ec74f-41ce-480e-9f50-d885e2da6ae2/documents/IUC5-70c040fb-34eb-4c3b-a0c8-fd1521d6e6aa_6023b5a2-2084-4dd2-8f71-753a1de8ee3f.html,,,,,, (Z)-hex-3-enyl acetate,3681-71-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/770ec74f-41ce-480e-9f50-d885e2da6ae2/documents/IUC5-70c040fb-34eb-4c3b-a0c8-fd1521d6e6aa_6023b5a2-2084-4dd2-8f71-753a1de8ee3f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat (Z)-hex-3-enyl acetate,3681-71-8,Acute oral toxicity: The test substance was found to have a LD50 greater than 2000 mg/kg bodyweight.Acute inhalation toxicity: The test substance was found to have an LC50 greater than 5.92 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/770ec74f-41ce-480e-9f50-d885e2da6ae2/documents/IUC5-faaa0bfa-fb69-40be-a46d-946a4df096b4_6023b5a2-2084-4dd2-8f71-753a1de8ee3f.html,,,,,, (Z)-hex-3-enyl benzoate,25152-85-6,Acute oral toxicity: similar or equivalent to OECD TG 401: LD50 > 5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6022c9a6-867b-4ef8-987e-345e6a149a0a/documents/IUC5-495bc9fa-b22a-44e9-95a7-8449e92aa31e_6ff4a403-92b7-4420-9778-1c2a693b929a.html,,,,,, (Z)-hex-3-enyl (Z)-hex-3-enoate,61444-38-0,"Oral: LD50= > 2000 mg/kg bw, male/female rat, OECD 423, RCC Ltd Toxicology Division 2000 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/064da7c3-a304-4bce-a515-305f25ac1c36/documents/IUC5-86503461-cb5a-4ce5-8a6c-319b88a6e48b_c12aba1a-328d-4ce0-b0ca-8499dc19b8bc.html,,,,,, (Z)-hex-3-enyl (Z)-hex-3-enoate,61444-38-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/064da7c3-a304-4bce-a515-305f25ac1c36/documents/IUC5-86503461-cb5a-4ce5-8a6c-319b88a6e48b_c12aba1a-328d-4ce0-b0ca-8499dc19b8bc.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, (Z)-hex-3-enyl isobutyrate,41519-23-7," WoE appraoch based on the two Klimish 4 tests below : - Acute Oral Toxicity Of Selected Flavor Chemicals, Drug And Chemical Toxicology, 3(3), 249-258 dated on 1980 _ LD50 (Oral) = 250000 ml/Kg bw - Acute Oral toxicity in rats on Cis-3-Hexenyl Isobutyrate abstract_ dated on 1976_LD50 (Oral) > 5000 mg/Kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69955dd1-40d7-4e0f-a67c-5960720c6def/documents/796a74ee-d50c-44cf-944c-6054996f4dc0_4f1ece6f-a20e-4756-908b-315310b2afb3.html,,,,,, (Z)-hex-3-enyl isobutyrate,41519-23-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69955dd1-40d7-4e0f-a67c-5960720c6def/documents/796a74ee-d50c-44cf-944c-6054996f4dc0_4f1ece6f-a20e-4756-908b-315310b2afb3.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, cis-hex-3-en-1-yl methyl carbonate,67633-96-9,Acute oral (OECD TG 401): > 5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f038f806-ef9d-4192-9ee2-f33a7c93ca5e/documents/eb296330-49b3-45f4-9eb3-80ce2e9a0eb6_3610d79d-09d6-41e5-90f7-3c961f2362d6.html,,,,,, (Z)-3-hexenyl salicylate,65405-77-8,90-day toxicity study (OECD 408): NOAEL 100 mg/kg bw/day combined repeated dose and reproduction / developmental screening (OECD 422): NOAEL 200 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2de559e2-f9e0-416e-834b-5aa06e54c3b1/documents/IUC5-66b6a279-bf07-40a8-9ff0-761b295ce350_e364341e-f8fd-4d94-a849-2b0ada9f4c85.html,,,,,, (Z)-3-hexenyl salicylate,65405-77-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2de559e2-f9e0-416e-834b-5aa06e54c3b1/documents/IUC5-66b6a279-bf07-40a8-9ff0-761b295ce350_e364341e-f8fd-4d94-a849-2b0ada9f4c85.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat (Z)-3-hexenyl salicylate,65405-77-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2de559e2-f9e0-416e-834b-5aa06e54c3b1/documents/IUC5-66b6a279-bf07-40a8-9ff0-761b295ce350_e364341e-f8fd-4d94-a849-2b0ada9f4c85.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat (Z)-3-hexenyl salicylate,65405-77-8,ORAL Acute oral LD50 was determined to be LD50 3330 mg/kg (male) and 3031 mg/kg (female) in the rat; study conducted in accordance with OECD 401; Potokar (1984a)   DERMAL Acute dermal LD50 was determined to be >2000 mg/kg bw (male/female); rabbit; study conducted in accordance with EU Method B3; Kästner (1984)   ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2de559e2-f9e0-416e-834b-5aa06e54c3b1/documents/IUC5-63c4b563-10dd-47a4-9cae-c8e6a168e599_e364341e-f8fd-4d94-a849-2b0ada9f4c85.html,,,,,, (Z)-3-hexenyl salicylate,65405-77-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2de559e2-f9e0-416e-834b-5aa06e54c3b1/documents/IUC5-63c4b563-10dd-47a4-9cae-c8e6a168e599_e364341e-f8fd-4d94-a849-2b0ada9f4c85.html,,oral,LD50,"3,031 mg/kg bw",no adverse effect observed, (Z)-3-hexenyl salicylate,65405-77-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2de559e2-f9e0-416e-834b-5aa06e54c3b1/documents/IUC5-63c4b563-10dd-47a4-9cae-c8e6a168e599_e364341e-f8fd-4d94-a849-2b0ada9f4c85.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 3-methyl-2-pent-2-enylcyclopent-2-enone,488-10-8," Oral: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD TG 422, GLP): NOAEL (m) = 92.17 mg/kg bw/day / NOAEL (f) = 96.63 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc04b1a0-d08b-494d-8fc9-8786f0030a07/documents/4c75e9c1-29e4-41aa-bdf1-7ac8ac4fdb21_0f1b2a76-207e-4e8f-a787-9490370a1312.html,,,,,, 3-methyl-2-pent-2-enylcyclopent-2-enone,488-10-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc04b1a0-d08b-494d-8fc9-8786f0030a07/documents/4c75e9c1-29e4-41aa-bdf1-7ac8ac4fdb21_0f1b2a76-207e-4e8f-a787-9490370a1312.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,92.17 mg/kg bw/day,,rat 3-methyl-2-pent-2-enylcyclopent-2-enone,488-10-8," Oral (no guideline stated), male/female rats: LD50 = 4300 mg/kg bw Dermal (no guideline stated), rabbits: LD50 > 5000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc04b1a0-d08b-494d-8fc9-8786f0030a07/documents/61346df4-981e-4740-9601-95910656d4da_0f1b2a76-207e-4e8f-a787-9490370a1312.html,,,,,, 3-methyl-2-pent-2-enylcyclopent-2-enone,488-10-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc04b1a0-d08b-494d-8fc9-8786f0030a07/documents/61346df4-981e-4740-9601-95910656d4da_0f1b2a76-207e-4e8f-a787-9490370a1312.html,,oral,LD50,"4,300 mg/kg bw",no adverse effect observed, 3-methyl-2-pent-2-enylcyclopent-2-enone,488-10-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc04b1a0-d08b-494d-8fc9-8786f0030a07/documents/61346df4-981e-4740-9601-95910656d4da_0f1b2a76-207e-4e8f-a787-9490370a1312.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, (Z)-tetrahydro-6-(2-pentenyl)-2H-pyran-2-one,25524-95-2, The acute median lethal dose (LD50) in rats following single oral administration of Jasminlactone was greater than 4000 mg/kg in female or male rats. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcd6ffa3-f3b1-451e-a924-c4d1d2385aca/documents/7ee6f95b-e560-486b-a956-053fcc133e2a_82bc4e25-73fd-4b30-9a5b-c918fcbb8ee3.html,,,,,, (Z)-tetrahydro-6-(2-pentenyl)-2H-pyran-2-one,25524-95-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcd6ffa3-f3b1-451e-a924-c4d1d2385aca/documents/7ee6f95b-e560-486b-a956-053fcc133e2a_82bc4e25-73fd-4b30-9a5b-c918fcbb8ee3.html,,oral,LD50,"> 4,000 mg/kg bw",no adverse effect observed, "Cistus ladaniferus, ext.",8016-26-0,"Toxicidad por dosis repetidas: LD50 ORAL RAT: 8980 mg / kg Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Irritant to mucous membranes, membranes and upper respiratory tract. May be harmful by inhalation ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/316de5b9-3910-4d4e-8ced-9db8ef0f8cc3/documents/fcb11ffc-220b-4bb2-9060-564cc30dbdef_095664a3-2295-46ae-8929-24ac8e8db9f1.html,,,,,, "Cistus ladaniferus, ext.",8016-26-0,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/316de5b9-3910-4d4e-8ced-9db8ef0f8cc3/documents/fcb11ffc-220b-4bb2-9060-564cc30dbdef_095664a3-2295-46ae-8929-24ac8e8db9f1.html,Sub-chronic toxicity – systemic effects,oral,,"8,980 mg/kg bw/day",,guinea pig "Cistus ladaniferus, ext.",8016-26-0,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/316de5b9-3910-4d4e-8ced-9db8ef0f8cc3/documents/fcb11ffc-220b-4bb2-9060-564cc30dbdef_095664a3-2295-46ae-8929-24ac8e8db9f1.html,Sub-chronic toxicity – systemic effects,inhalation,,"8,980 mg/m3",,guinea pig "Cistus ladaniferus, ext.",8016-26-0,Repeated dose toxicity: LD50 ORAL RAT: 8980 mg / kg ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/316de5b9-3910-4d4e-8ced-9db8ef0f8cc3/documents/8628c0ba-f601-4c95-acee-64144daa5dcb_095664a3-2295-46ae-8929-24ac8e8db9f1.html,,,,,, Citraconic anhydride,616-02-4,This substance is an on-site isolated intermediate and therefore no additional testing is warranted. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f735399a-2921-4449-a755-98c4d7bb7b90/documents/IUC5-53eb5cbd-757a-45db-b82b-48a9dba0ce9b_8902f22d-fb21-4578-b22b-f0e0bd916902.html,,,,,, Citraconic anhydride,616-02-4," The substance is known to be corrosive to skin so acute toxicity testing is unjustified. The substance is an intermediate used under SCC and therefore exposure via oral, dermal and /or inhalation is unlikely. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f735399a-2921-4449-a755-98c4d7bb7b90/documents/IUC5-c5cc1fe8-442e-4512-9c52-ad925ce3f568_8902f22d-fb21-4578-b22b-f0e0bd916902.html,,,,,, Citral,5392-40-5,"Chronic oral toxicity (similar to OECD TG 453, according to GLP; NTP 2003c-d)rat: NOAEL 100 mg/kg bw/dmouse: LOAEL 60 mg/kg bw/d for femalesSubchronic inhalation toxicity (Weight of evidence: Gaworski 1992,1993)rat: NOAEC 34 ppm = 215 mg/m3 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1f8aa3c-7974-475b-ad48-4553fe006eb4/documents/IUC5-be31af8b-3690-47cc-93e8-d365fc026f07_28a905eb-05b3-4aec-94b7-57130120aaee.html,,,,,, Citral,5392-40-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1f8aa3c-7974-475b-ad48-4553fe006eb4/documents/IUC5-be31af8b-3690-47cc-93e8-d365fc026f07_28a905eb-05b3-4aec-94b7-57130120aaee.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,60 mg/kg bw/day,, Citral,5392-40-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1f8aa3c-7974-475b-ad48-4553fe006eb4/documents/IUC5-be31af8b-3690-47cc-93e8-d365fc026f07_28a905eb-05b3-4aec-94b7-57130120aaee.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,215 mg/m3,, Citral,5392-40-5,Acute oral toxicity: LD50 rat 6800 mg/kgAcute dermal toxicity: LD50 rat > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1f8aa3c-7974-475b-ad48-4553fe006eb4/documents/IUC5-5e7057bc-f691-4f31-a77e-74c6e5fa2987_28a905eb-05b3-4aec-94b7-57130120aaee.html,,,,,, "1,1-diethoxy-3,7-dimethylocta-2,6-diene",7492-66-2," Repeated dose oral toxicity test was performed on male and female rats to determine the oral toxic nature of Citral diethyacetal. The animals were treated with the test chemical Citral diethylacetal at a dose level of 0 or 56 mg/Kg bw for 12 weeks (84 days). The animals were observed for Daily food consumption, growth rate, food intake and efficiency, gross pathology including organ weight and haemoglobin concentration. The treated animals had normal behaviour and appearance during the study. Growth, food intake, and efficiency of food use were reported not to be affected, and gross examination revealed no changes in organ weights or haemoglobin concentration. Hence, the No Observed Adverse Effect Level (NOAEL) for Citral diethylacetal is 56 mg/kg in male and female rats. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8abb3e8-423c-492a-84bc-045ae731ad86/documents/adb77570-d8fc-477e-b383-f1896a1bc3c9_e4b6bca6-653d-4b34-bac3-9344cf3f2d7c.html,,,,,, "1,1-diethoxy-3,7-dimethylocta-2,6-diene",7492-66-2,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8abb3e8-423c-492a-84bc-045ae731ad86/documents/adb77570-d8fc-477e-b383-f1896a1bc3c9_e4b6bca6-653d-4b34-bac3-9344cf3f2d7c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,56 mg/kg bw/day,,rat "1,1-diethoxy-3,7-dimethylocta-2,6-diene",7492-66-2," Acute oral toxicity: LD50 was considered to be > 5000 mg/kg bw when male rat were treated with 1,1-diethoxy-3,7-dimethylocta-2,6-diene orally. Acute dermal toxicity: LD50 was considered to be > 5000 mg/kg bw when rabbits were treated with 1,1-diethoxy-3,7-dimethylocta-2,6-diene dermally. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8abb3e8-423c-492a-84bc-045ae731ad86/documents/c42e4ce7-6ba7-4143-a0a1-a39e520e4911_e4b6bca6-653d-4b34-bac3-9344cf3f2d7c.html,,,,,, "1,1-diethoxy-3,7-dimethylocta-2,6-diene",7492-66-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8abb3e8-423c-492a-84bc-045ae731ad86/documents/c42e4ce7-6ba7-4143-a0a1-a39e520e4911_e4b6bca6-653d-4b34-bac3-9344cf3f2d7c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "1,1-diethoxy-3,7-dimethylocta-2,6-diene",7492-66-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8abb3e8-423c-492a-84bc-045ae731ad86/documents/c42e4ce7-6ba7-4143-a0a1-a39e520e4911_e4b6bca6-653d-4b34-bac3-9344cf3f2d7c.html,,dermal,LD50,"5,000 ",no adverse effect observed, "2,6-Octadienal, 3,7-dimethyl-, acid-isomerized",90480-35-6," For this endpoint a Combined Repeated Dose Toxicity 28-day / Reproduction/Developmental Toxicity Screening Test was performed. The study was performed in accordance to OECD TG 422 and in compliance to GLP. The No-Observed-Adverse-Effect Level (NOAEL) for general systemic toxicity when the test item is administered via oral gavage to Sprague-Dawley rats with dose levels of 0, 35, 150 and 600 mg/kg bw/day is considered to be 150 mg/kg/day for both sexes. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38f351a5-125f-4cf0-9fa6-b79d565ef11d/documents/47715e4d-7ca2-4233-a48c-2d44437dab9d_c15cd103-031f-489a-bc8f-64f7b24f658e.html,,,,,, "2,6-Octadienal, 3,7-dimethyl-, acid-isomerized",90480-35-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38f351a5-125f-4cf0-9fa6-b79d565ef11d/documents/47715e4d-7ca2-4233-a48c-2d44437dab9d_c15cd103-031f-489a-bc8f-64f7b24f658e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "2,6-Octadienal, 3,7-dimethyl-, acid-isomerized",90480-35-6," For the enpoint of acute toxicity two key studies are available: one for acute oral toxicity and one for acute dermal toxicity. No data are available on acute toxicity via inhalation route. Both studies were performed according to their respective OECD test guidelines and in accordance to GLP. Acute oral toxicity The substance is not acute oral toxic. The oral LD50 is > 5000 mg/kg bw. Acute dermal toxicity Based on the result of this study, the LD50 value of the test substance was considered to be > 2000 mg/kg in male and female rats under the conditions of this study. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38f351a5-125f-4cf0-9fa6-b79d565ef11d/documents/02a48a8d-db6c-4bf7-910d-8c752071e112_c15cd103-031f-489a-bc8f-64f7b24f658e.html,,,,,, "2,6-Octadienal, 3,7-dimethyl-, acid-isomerized",90480-35-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38f351a5-125f-4cf0-9fa6-b79d565ef11d/documents/02a48a8d-db6c-4bf7-910d-8c752071e112_c15cd103-031f-489a-bc8f-64f7b24f658e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,6-Octadienal, 3,7-dimethyl-, acid-isomerized",90480-35-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38f351a5-125f-4cf0-9fa6-b79d565ef11d/documents/02a48a8d-db6c-4bf7-910d-8c752071e112_c15cd103-031f-489a-bc8f-64f7b24f658e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Citric acid,77-92-9," There are no reliable 28-day or 90-day studies available, so this endpoint is waived. Numerous studies have been reported in the literature and are discussed below. The most reliable studies are 10-day studies in rats and mice, with the following results: NOAEL (10 d) 4000 mg/kg bw/day rats (unidentified gender)   LD50 (10 d) 5660 (+/- 0.44) mg/kg bw/day rats (unidentified gender) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/891540c8-350a-4291-95ce-9a577d99f6e7/documents/a2f9a327-8091-4ef4-bdd8-9cda28b39bd8_42f4482c-740b-4789-a8b3-812cd2cc024d.html,,,,,, Citric acid,77-92-9," An acute oral LD50 value of 5400 mg/kg bw in mouse is reported in a reliability 2 study which is broadly equivalent to the OECD test guideline 401 (Roche 1981). An acute dermal LD50 value of >2000mg/kg bw in rat was determined in a reliable study conducted according to OECD 402 and in compliance with GLP (Safepharm, 2006; rel 1). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/891540c8-350a-4291-95ce-9a577d99f6e7/documents/ff43db99-0ab6-43e9-9418-703beca0e3b0_42f4482c-740b-4789-a8b3-812cd2cc024d.html,,,,,, Citric acid,77-92-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/891540c8-350a-4291-95ce-9a577d99f6e7/documents/ff43db99-0ab6-43e9-9418-703beca0e3b0_42f4482c-740b-4789-a8b3-812cd2cc024d.html,,oral,LD50,"5,400 mg/kg bw",no adverse effect observed, Citric acid,77-92-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/891540c8-350a-4291-95ce-9a577d99f6e7/documents/ff43db99-0ab6-43e9-9418-703beca0e3b0_42f4482c-740b-4789-a8b3-812cd2cc024d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Citronellol,106-22-9,Acute toxicity:- oral: LD50 = 3450 mg/kg bw- dermal: LD50 = 2650 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57ce44ea-da6e-4e32-9aeb-83c954aeb73d/documents/IUC5-f222f279-8a10-451a-8be9-2bb3ed39b072_00eb9696-e133-4251-86b7-3dcc2ad572c6.html,,,,,, Citronellol,106-22-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57ce44ea-da6e-4e32-9aeb-83c954aeb73d/documents/IUC5-f222f279-8a10-451a-8be9-2bb3ed39b072_00eb9696-e133-4251-86b7-3dcc2ad572c6.html,,oral,LD50,"3,450 mg/kg bw",, Citronellol,106-22-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57ce44ea-da6e-4e32-9aeb-83c954aeb73d/documents/IUC5-f222f279-8a10-451a-8be9-2bb3ed39b072_00eb9696-e133-4251-86b7-3dcc2ad572c6.html,,dermal,LD50,"2,650 mg/kg bw",, "(-)-3,7-dimethyloct-6-en-1-ol",7540-51-4," This endpoint was read across from three structurally similar substances, in a weight of evidence approach. The substances were 1) a mixture of linalool/citronellol (3,7-dimethyloct-6-en-1-ol, CAS 106-22-9 / 3,7-dimethylocta-1,6-dien-3-ol, CAS 78-70-6, 50% each), 2) a mixture of geraniol (3,7-dimethyl-2,6-octadienol) and the isomer (3,7-dimethyl-1,6-octadienol), and 3) citronellyl acetate in a geranyl acetate mixture (71% geranyl acetate (3,7-dimethylocta-2,6-dien-1-yl acetate (E)-, CAS 105-87-3) and 29% citronellyl acetate (3,7-dimethyloct-6-en-1-yl acetate, CAS 150-84-5)). In a feeding study in rats from secondary literature, a mixture of linalool/citronellol (50% each) were orally administered daily for 90 days, thus giving a daily amount of approx. 50 mg/kg bw/d citronellol (Trubek, 1958). Food intake and body weight gain was reduced in males, however, the authors attributed this effect to be caused by the palatability of the given mixture and considered these effects to be biologically insignificant. In a limited urine analysis, in haematology, in gross examinations and in liver and kidney weights, no test substance related effects were observed. The NOEL was determined as 51 and 56 mg/kg bw/d (the highest doses tested) citronellol for males and female, respectively.   A mixture of geraniol (3,7-dimethyl-2,6-octadienol) and the isomer (3,7-dimethyl-1,6-octadienol) was fed to five male and five female individually housed Osborne-Mendel rats per dose group (Hagan, 1967). Thereby, a concentrations of 1000 ppm (= ca. 55 mg/kg bw/day) was administered for 189-169 days and a concentration of 10000 ppm (= ca. 550 mg/kg bw/day) was given for 112 days. During the study, the food consumption was monitored and blood was collected at the end of study and was subjected analysis of white cell counts, red cell counts and hemoglobin and hematocrit content. Also, animals were necropsied and histopathology was performed. Since no clinical signs, no effects on body weight as well as no histopathological changes were observed, the NOEL could be estimated as 10000 ppm. Thus the NOAEL would be > 550 mg/kg bw/day.   Repeated dose toxicity was analyzed in a 13 week oral toxicity study in rats performed by the National Toxicity Program of the US National Institutes of Health (NTP, 1987). In this study, doses of 250, 500, 1000, 2000 and 4000 mg/kg bw/d of food-grade geranyl acetate (71% geranyl acetate (CAS 105-87-3) and 29% citronellyl acetate (CAS 150-84-5)) in corn oil was administered by gavage to ten male and female Fischer 344 rats for 13 weeks. 1/10 female and 2/10 male of the 4000 mg/kg bw/d group died, in addition to one animal accidently killed by gavage error in the 500 mg/kg bw/d group. Besides mortality, the observed substance related toxic effect was a depressed mean body weight of the animals of the 4000 mg/kg bw/d group compared to control (19% for the males, 8% for the females). Three males showed reddened mucosa of the stomach, however no test substance related histopathological changes were observed. Thus, a NOAEL of 2000 mg/kg bw/d of food-grade geranyl acetate has been set, corresponding to 580 mg/kg bw/d citronellyl acetate. In the same study, also, ten male and female B6C3F1 mice per dose were gavaged by doses of 125, 250, 500, 1000, 2000 mg/kg bw food-grade geranyl acetate in corn oil for the 13 week study. Seven males and nine females of the 2000 mg/kg bw group died. Also, three females of the lower dose groups died, but this was accidentally due to an error of gavage. No other clinical signs of toxicity were noted during the study. The males of the 2000 mg/kg bw group exhibit a delay in body weight gain. Liver, kidney and myocardium of males and females of the 2000 mg/kg bw group displayed cytoplasmic vacuolization with lipid inclusions indicative of fatty degeneration. Furthermore, stomach lesions including inflammation and edema were reported in this group. Thus, the NOAEL was set at 1000 mg/kg bw/d food-grade geranyl acetate corresponding to 290 mg/kg bw/d citronellyl acetate. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df148ef7-1c4b-4fcd-be48-6f689b3c7f3c/documents/f38ae06f-bd22-4600-a697-dd7bf94ec91d_1b4a1f06-4f7e-445e-ac51-6a36586e0a81.html,,,,,, "(-)-3,7-dimethyloct-6-en-1-ol",7540-51-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df148ef7-1c4b-4fcd-be48-6f689b3c7f3c/documents/f38ae06f-bd22-4600-a697-dd7bf94ec91d_1b4a1f06-4f7e-445e-ac51-6a36586e0a81.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "(-)-3,7-dimethyloct-6-en-1-ol",7540-51-4," These endpoints were fulfilled using read across from Citronellol (3,7-dimethyl-6-Octen-1-ol, CAS 106 -22 -9). Acute oral toxicity The acute oral toxicity of the substance was assessed in rats at doses 2025 – 5000 mg/kg bw. The LD 50 was 3450 mg/kg bw. Acute dermal toxicity The acute dermal toxicity was assessed in rabbits according toe the standard acute method. Doses of 1250, 2500 and 5000 mg.kg bw were tested. The LD 50 value was 2650 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df148ef7-1c4b-4fcd-be48-6f689b3c7f3c/documents/9d73d3a3-013b-469f-a1c6-d001aae468bf_1b4a1f06-4f7e-445e-ac51-6a36586e0a81.html,,,,,, "(-)-3,7-dimethyloct-6-en-1-ol",7540-51-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df148ef7-1c4b-4fcd-be48-6f689b3c7f3c/documents/9d73d3a3-013b-469f-a1c6-d001aae468bf_1b4a1f06-4f7e-445e-ac51-6a36586e0a81.html,,oral,LD50,"3,450 mg/kg bw",no adverse effect observed, "(-)-3,7-dimethyloct-6-en-1-ol",7540-51-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df148ef7-1c4b-4fcd-be48-6f689b3c7f3c/documents/9d73d3a3-013b-469f-a1c6-d001aae468bf_1b4a1f06-4f7e-445e-ac51-6a36586e0a81.html,,dermal,LD50,"2,650 mg/kg bw",no adverse effect observed, Citronellyl acetate,150-84-5,Acute toxicity:- oral: LD50 = 6800 mg/kg bw (Calandra 1971)- dermal: LD50 >2000 mg/kg bw (Calandra 1971) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b95ee255-aa82-4bfd-9eea-4418c1e7daba/documents/IUC5-1fdd7a5d-11cf-4ea6-bbd0-41b47a2f4eb4_3fe97f97-7ea9-49d4-a8ab-983df4535268.html,,,,,, Citronellyl butyrate,141-16-2," Oral (OECD 423), rat: LD50 cut-off >= 5000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8b1b3f2-17df-4f1b-aa72-af2e9a71b185/documents/22d266af-5098-436d-b511-4870179a2e3e_7c856f85-fa07-4297-a27a-d6bd30198a07.html,,,,,, Citronellyl formate,105-85-1, The NOAEL for systemic toxicity was considered to be 800 mg/kg/day for animals of both sexes. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3408b800-1e06-4468-ba77-516dce8f5ff0/documents/b6097842-0de9-4870-b95d-af42bee99598_46441aa2-3186-4e52-95dc-e52f0b76dfd7.html,,,,,, Citronellyl formate,105-85-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3408b800-1e06-4468-ba77-516dce8f5ff0/documents/b6097842-0de9-4870-b95d-af42bee99598_46441aa2-3186-4e52-95dc-e52f0b76dfd7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,800 mg/kg bw/day,,rat Citronellyl formate,105-85-1," In an acute oral toxicity study with rats, performed equivalent to OECD 401 guidelines, an LD50 of >6800 mg/kg bw was determined. In an acute dermal toxicity study with rats, performed equivalent to OECD 402 guidelines, an LD50 of >2000 mg/kg bw was determined. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3408b800-1e06-4468-ba77-516dce8f5ff0/documents/d0bfb440-eb5e-4c4d-befe-896dbbb67aff_46441aa2-3186-4e52-95dc-e52f0b76dfd7.html,,,,,, "3,7-dimethyloct-6-enyl isobutyrate",97-89-2," Acute oral toxicity:  In acute oral toxicity study, rat were treated with test chemical in the concentration of 5000 mg/kg bw orally. No mortality was observed at 5000 mg/kg bw in treated rat. Therefore, LD50 was considered to be > 5000 mg/kg bw when rats were treated with test chemical orally.   Acute Inhalation Toxicity:   The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.01425 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: In acute dermal toxicity study, rabbits were treated with test chemical in the concentration of 5000 mg/kg bw orally. No mortality was observed at 5000 mg/kg bw in treated rabbits. Therefore, LD50 was considered to be > 5000 mg/kg bw when rabbits were treated with test chemical dermally. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f3bd548-480b-4ec7-9b74-c885677a1de3/documents/4581d7b5-3fd2-441e-be6a-4b38af140c34_dfa83ba4-b0c6-419e-8c61-31b2f4528449.html,,,,,, "3,7-dimethyloct-6-enyl isobutyrate",97-89-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f3bd548-480b-4ec7-9b74-c885677a1de3/documents/4581d7b5-3fd2-441e-be6a-4b38af140c34_dfa83ba4-b0c6-419e-8c61-31b2f4528449.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,7-dimethyloct-6-enyl isobutyrate",97-89-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f3bd548-480b-4ec7-9b74-c885677a1de3/documents/4581d7b5-3fd2-441e-be6a-4b38af140c34_dfa83ba4-b0c6-419e-8c61-31b2f4528449.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,7-dimethyloct-6-enenitrile",51566-62-2,"90 day repeated dose toxicity study, rat, oral (OECD 408, GLP): NOAEL = 300 mg/kg bw/d (highest dose tested; Safepharm Laboratories, 2008) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32e9987c-07fc-404f-9672-cd3be80c1d43/documents/IUC5-6d6d34c6-34d0-49ca-963d-f05b77665cb6_49c58468-9bb7-4f64-a04e-c3c4bcf61a7f.html,,,,,, "3,7-dimethyloct-6-enenitrile",51566-62-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32e9987c-07fc-404f-9672-cd3be80c1d43/documents/IUC5-6d6d34c6-34d0-49ca-963d-f05b77665cb6_49c58468-9bb7-4f64-a04e-c3c4bcf61a7f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "3,7-dimethyloct-6-enenitrile",51566-62-2,"Acute oral toxicty: LD50=4490 mg/kg bw (Consumer Product Testing Company, 1979).Acute inhalation toxicty: LC50 > 4.9 mg/L air (BASF, 1982).Acute dermal toxicty: LD50 >5.0 mg/kg bw (RIFM, 1977). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32e9987c-07fc-404f-9672-cd3be80c1d43/documents/IUC5-04aa7bbb-045b-4860-9671-8c429d0feaa3_49c58468-9bb7-4f64-a04e-c3c4bcf61a7f.html,,,,,, "Lime (Citrus aurantifolia), ext.",90063-52-8,"Acute oral toxicity: LD50 > 4.367 g/kg bw (5 ml/kg bw) (standard acute method, limit test; similar to OECD 401)Acute dermal toxicity: LD50 > 4.367 g/kg bw (5 ml/kg bw) (standard acute method, limit test; similar to OECD 402) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ac1cadd-3dc7-4ef3-bf92-04b301cc25e6/documents/IUC5-28341852-c314-4b74-917d-efe21f905fc0_33049ce5-3404-4512-bcc1-bd66c223870a.html,,,,,, "Lime (Citrus aurantifolia), ext.",90063-52-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ac1cadd-3dc7-4ef3-bf92-04b301cc25e6/documents/IUC5-28341852-c314-4b74-917d-efe21f905fc0_33049ce5-3404-4512-bcc1-bd66c223870a.html,,oral,LD50,"4,367 mg/kg bw",, "Lime (Citrus aurantifolia), ext.",90063-52-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ac1cadd-3dc7-4ef3-bf92-04b301cc25e6/documents/IUC5-28341852-c314-4b74-917d-efe21f905fc0_33049ce5-3404-4512-bcc1-bd66c223870a.html,,dermal,LD50,"4,367 mg/kg bw",, "Orange, sour, ext.",72968-50-4,"Acute toxicity oral:- Standard acute method (rat): LD50 > 5000 mg/kg bw (limit test, not according to guideline)Acute toxicity dermal: - Standard acute method (rabbit): LD50 > 8.5 g/kg bw (limit test, not according to guideline) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fbfe5a85-4c73-441d-b7ba-2d40599f6bc8/documents/IUC5-87ff0bb0-3210-4fdc-a107-3633aa8b04c1_e277fc14-ca09-4970-9463-e3e39722095b.html,,,,,, "Orange, sour, ext.",72968-50-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fbfe5a85-4c73-441d-b7ba-2d40599f6bc8/documents/IUC5-87ff0bb0-3210-4fdc-a107-3633aa8b04c1_e277fc14-ca09-4970-9463-e3e39722095b.html,,oral,LD50,"5,000 mg/kg bw",, "Orange, sour, ext.",72968-50-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fbfe5a85-4c73-441d-b7ba-2d40599f6bc8/documents/IUC5-87ff0bb0-3210-4fdc-a107-3633aa8b04c1_e277fc14-ca09-4970-9463-e3e39722095b.html,,dermal,LD50,"8,500 mg/kg bw",, "Bergamot, ext.",89957-91-5,"Repeated dose toxicity via oral route (WoE):- Subacute oral toxicity study in rats (similar to OECD 407, read-across): NOAEL = 117 mg/kg bw/day- Subchronic (6-month) toxicity study in dogs (similar to OECD 409, read-across): NOAEL = 100 mg/kg bw/day- Subchronic toxicity study in rats (similar to OECD 408, read-across): NOAEL = 600 mg/kg bw/day- Subchronic toxicity study in mice (similar to OECD 408, read-across): NOAEL = 500 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ccc156f-f0d7-4610-bd62-3640394f56a0/documents/IUC5-853512c8-7a57-4c90-a61e-b9b5d0504868_dd061c0a-077c-4b5f-b662-65f3fd841b3b.html,,,,,, "Bergamot, ext.",89957-91-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ccc156f-f0d7-4610-bd62-3640394f56a0/documents/IUC5-853512c8-7a57-4c90-a61e-b9b5d0504868_dd061c0a-077c-4b5f-b662-65f3fd841b3b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,117 mg/kg bw/day,,rat "Bergamot, ext.",89957-91-5,Acute oral toxicity: LD50>10000 mg/kg bw (similar to OECD guideline 401)Acute dermal toxicity: LD50>20000 mg/kg bw (similar to OECD guideline 402) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ccc156f-f0d7-4610-bd62-3640394f56a0/documents/IUC5-b237299b-f67c-4920-8b19-4efa76e164e4_dd061c0a-077c-4b5f-b662-65f3fd841b3b.html,,,,,, "Bergamot, ext.",89957-91-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ccc156f-f0d7-4610-bd62-3640394f56a0/documents/IUC5-b237299b-f67c-4920-8b19-4efa76e164e4_dd061c0a-077c-4b5f-b662-65f3fd841b3b.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Bergamot, ext.",89957-91-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ccc156f-f0d7-4610-bd62-3640394f56a0/documents/IUC5-b237299b-f67c-4920-8b19-4efa76e164e4_dd061c0a-077c-4b5f-b662-65f3fd841b3b.html,,dermal,LD50,"20,000 mg/kg bw",no adverse effect observed, "Orange, sweet, ext.",8028-48-6,Repeated dose toxicity: oralWeight of evidence approach6-month repeated dose toxicity study in dogs: LOAEL 1000 mg/kg bw/day90-day repeated dose toxicity study in mice: LOAEL 1000 mg/kg bw/day90-day repeated dose toxicity study in rats: LOAEL 1200 mg/kg bw/daysupporting 6-month repeated dose toxicity study in dogs: LOAEL 1000 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc3b54e7-cb62-4ab3-a6d4-eeee3fdded72/documents/IUC5-e4d77b52-a9ba-4527-bc77-a2672e775f57_e099ca2e-c9c7-43f1-8614-452e0459a8a4.html,,,,,, "Orange, sweet, ext.",8028-48-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc3b54e7-cb62-4ab3-a6d4-eeee3fdded72/documents/IUC5-e4d77b52-a9ba-4527-bc77-a2672e775f57_e099ca2e-c9c7-43f1-8614-452e0459a8a4.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,"1,000 mg/kg bw/day",,other:WoE approach "Orange, sweet, ext.",8028-48-6,"Acute oral toxicity: LD50>5000 mg/kg bw (standard acute method, limit test)Acute dermal toxicity: LD50>5000 mg/kg bw (standard acute method, limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc3b54e7-cb62-4ab3-a6d4-eeee3fdded72/documents/IUC5-d7cc6684-adbf-4cc3-b82a-9cbdab5be25c_e099ca2e-c9c7-43f1-8614-452e0459a8a4.html,,,,,, "Orange, sweet, ext.",8028-48-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc3b54e7-cb62-4ab3-a6d4-eeee3fdded72/documents/IUC5-d7cc6684-adbf-4cc3-b82a-9cbdab5be25c_e099ca2e-c9c7-43f1-8614-452e0459a8a4.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Orange, sweet, ext.",8028-48-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc3b54e7-cb62-4ab3-a6d4-eeee3fdded72/documents/IUC5-d7cc6684-adbf-4cc3-b82a-9cbdab5be25c_e099ca2e-c9c7-43f1-8614-452e0459a8a4.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Grapefruit, ext.",90045-43-5,Repeated dose toxicity: oralWeight of evidence approach6-month repeated dose toxicity study in dogs: LOAEL 1000 mg/kg bw/day90-day repeated dose toxicity study in mice: LOAEL 1000 mg/kg bw/day90-day repeated dose toxicity study in rats: LOAEL 1200 mg/kg bw/daysupporting 6-month repeated dose toxicity study in dogs: LOAEL 1000 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed07f119-47bf-4727-b82a-ffdc90bb4b2a/documents/IUC5-ecc1e511-482d-4536-a5a3-10d426b8ff40_69c8e72b-4edc-48a5-a03d-d6ad0d00d7b2.html,,,,,, "Grapefruit, ext.",90045-43-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed07f119-47bf-4727-b82a-ffdc90bb4b2a/documents/IUC5-ecc1e511-482d-4536-a5a3-10d426b8ff40_69c8e72b-4edc-48a5-a03d-d6ad0d00d7b2.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,"1,000 mg/kg bw/day",, "Grapefruit, ext.",90045-43-5,"Acute oral toxicity:LD50 > 5000 mg/kg bw (standard acute method, limit test; similar to OECD 401)Acute dermal toxicity:LD50 > 5000 mg/kg bw (standard acute method, limit test; similar to OECD 402) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed07f119-47bf-4727-b82a-ffdc90bb4b2a/documents/IUC5-99de4b2e-8c81-4491-81e9-045073128a18_69c8e72b-4edc-48a5-a03d-d6ad0d00d7b2.html,,,,,, "Grapefruit, ext.",90045-43-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed07f119-47bf-4727-b82a-ffdc90bb4b2a/documents/IUC5-99de4b2e-8c81-4491-81e9-045073128a18_69c8e72b-4edc-48a5-a03d-d6ad0d00d7b2.html,,oral,LD50,"5,000 mg/kg bw",, "Grapefruit, ext.",90045-43-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed07f119-47bf-4727-b82a-ffdc90bb4b2a/documents/IUC5-99de4b2e-8c81-4491-81e9-045073128a18_69c8e72b-4edc-48a5-a03d-d6ad0d00d7b2.html,,dermal,LD50,"5,000 mg/kg bw",, "Lemon, ext.",84929-31-7,"Acute oral toxicity: LD50>5000 mg/kg bw (standard acute method, limit test)Acute dermal toxicity: LD50>10000 mg/kg bw (standard acute method, limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e07e9835-ca93-47c4-aea3-037270df3835/documents/IUC5-ae8d5f6a-dbf5-4c24-b351-bac1bd7c272c_1cbbcd7c-6bf3-4771-a07c-051e9ddbe9b9.html,,,,,, "Lemon, ext.",84929-31-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e07e9835-ca93-47c4-aea3-037270df3835/documents/IUC5-ae8d5f6a-dbf5-4c24-b351-bac1bd7c272c_1cbbcd7c-6bf3-4771-a07c-051e9ddbe9b9.html,,oral,LD50,"5,000 mg/kg bw",, "Lemon, ext.",84929-31-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e07e9835-ca93-47c4-aea3-037270df3835/documents/IUC5-ae8d5f6a-dbf5-4c24-b351-bac1bd7c272c_1cbbcd7c-6bf3-4771-a07c-051e9ddbe9b9.html,,dermal,LD50,"10,000 mg/kg bw",, "Mandarin orange, ext.",84929-38-4,OECD TG 422: NOAEL 300 mg/kg bw/d ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0e2f954-4167-4655-a904-f3ff98e07c13/documents/IUC5-793ddb1c-bdd9-4602-8c46-1587b7723553_3d7f44f6-aa15-4bfb-87fa-8ca373ae2d58.html,,,,,, "Mandarin orange, ext.",84929-38-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0e2f954-4167-4655-a904-f3ff98e07c13/documents/IUC5-793ddb1c-bdd9-4602-8c46-1587b7723553_3d7f44f6-aa15-4bfb-87fa-8ca373ae2d58.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Mandarin orange, ext.",84929-38-4,"Acute toxicity oral:- Standard acute method (rat): LD50 > 5000 mg/kg bw (equivalent or similar to OECD401, limit test))Acute toxicity dermal: - Standard acute method (rabbit): LD50 > 5000 mg/kg bw (equivalent or similar to OECD402, limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0e2f954-4167-4655-a904-f3ff98e07c13/documents/IUC5-89f36f89-7e6f-482f-8cdb-037f7dddd928_3d7f44f6-aa15-4bfb-87fa-8ca373ae2d58.html,,,,,, "Mandarin orange, ext.",84929-38-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0e2f954-4167-4655-a904-f3ff98e07c13/documents/IUC5-89f36f89-7e6f-482f-8cdb-037f7dddd928_3d7f44f6-aa15-4bfb-87fa-8ca373ae2d58.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Mandarin orange, ext.",84929-38-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0e2f954-4167-4655-a904-f3ff98e07c13/documents/IUC5-89f36f89-7e6f-482f-8cdb-037f7dddd928_3d7f44f6-aa15-4bfb-87fa-8ca373ae2d58.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Tangor, Murcote, ext.",93686-22-7, Repeated dose toxicity: oral (read-across & Weight of evidence): - 6-month repeated dose toxicity study in dogs: LOAEL 1000 mg/kg bw/day - 90-day repeated dose toxicity study in mice: LOAEL 1000 mg/kg bw/day - 90-day repeated dose toxicity study in rats: LOAEL 1200 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79b4d27d-6b32-4eb0-86ae-fb770812ed1a/documents/97526962-7a66-4a44-b85d-04a4bcf894e6_c6ee7e2a-8d45-44bd-8c5f-60e74b2ac3d3.html,,,,,, "Tangor, Murcote, ext.",93686-22-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79b4d27d-6b32-4eb0-86ae-fb770812ed1a/documents/97526962-7a66-4a44-b85d-04a4bcf894e6_c6ee7e2a-8d45-44bd-8c5f-60e74b2ac3d3.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,"1,000 mg/kg bw/day",,"other:dog, mouse, rat" "Tangor, Murcote, ext.",93686-22-7, Acute oral toxicity (similar to OECD TG 401): LD50 > 5000 mg/kg bw Acute dermal toxicity (similar to OECD TG 402): LD50 > 5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79b4d27d-6b32-4eb0-86ae-fb770812ed1a/documents/IUC5-ead49a9b-f81d-4069-99b1-8bc36b5562f4_c6ee7e2a-8d45-44bd-8c5f-60e74b2ac3d3.html,,,,,, "Tangor, Murcote, ext.",93686-22-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79b4d27d-6b32-4eb0-86ae-fb770812ed1a/documents/IUC5-ead49a9b-f81d-4069-99b1-8bc36b5562f4_c6ee7e2a-8d45-44bd-8c5f-60e74b2ac3d3.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Tangor, Murcote, ext.",93686-22-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79b4d27d-6b32-4eb0-86ae-fb770812ed1a/documents/IUC5-ead49a9b-f81d-4069-99b1-8bc36b5562f4_c6ee7e2a-8d45-44bd-8c5f-60e74b2ac3d3.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,7-dimethylocta-2,6-dienyl acetate",16409-44-2," The NOAEL is 100 mg/kg bw, based on read-across from Geraniol 60 (Geraniol 60/Nerol 40%). Two studies are used to cover this repeated dose endpoint: The repeated dose toxicity from the OECD TG 414 developmental toxicity study of Geraniol 60 is used for deriving the NOAEL. The 13 wk study (similar to OECD TG 408) of Geranyl (Citronellyl) Acetate is used to cover the key repeated dose toxicity parameters. Since the outcomes of the OECD TG 414 study with Geraniol 60 is more conservative than the outcomes of the Geranyl (Citronellyl) Acetate study and the observed effects are similar, the Geraniol 60 study is used as the leading result for NOAEL derivation and would also conservatively reflect the effects of the 13 wk sub-chronic study. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73e8db70-3405-4943-bc23-c52970a3a073/documents/94cb139b-66bb-4317-a3f3-8e8390ee4d3a_4f8be1b9-ee49-4241-8ad5-ffc8c663106c.html,,,,,, "3,7-dimethylocta-2,6-dienyl acetate",16409-44-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73e8db70-3405-4943-bc23-c52970a3a073/documents/94cb139b-66bb-4317-a3f3-8e8390ee4d3a_4f8be1b9-ee49-4241-8ad5-ffc8c663106c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "3,7-dimethylocta-2,6-dienyl acetate",16409-44-2, Acute oral toxicity for Neryl acetate multi: LD50 >4555 mg/kg bw (based on read-across from Neryl Acetate mono tested in an OECD TG 401) Acute dermal toxicity for Neryl acetate multi: LD50 > 5466 mg/kg bw (based on read-across from Neryl Acetate mono tested in an OECD TG 402) Acute inhalation for Neryl aceate multi (oral to inhalation route extrapolation): LC50 > 11843 mg/m3. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73e8db70-3405-4943-bc23-c52970a3a073/documents/5f16bd79-330c-42f6-a28a-bc9be903382c_4f8be1b9-ee49-4241-8ad5-ffc8c663106c.html,,,,,, Climbazole,38083-17-9,The following four repeated dose toxicity studies were performed in rats with crinipan; in two studies each the test item was administered via the oral route or via the inhalation route.1. Sub-acute (28-day repeated) oral toxicity study in male Wistar rats: LOAEL 50 mg/kg bw/day2. Sub-chronic (90-day repeated) oral toxicity study in male and female rats: NOAEL 45 mg/kg bw/day)3. Sub-acute (21-day repeated) inhalation toxicity study in male and female rats (1976): LOAEC 69.1 mg/m34. Sub-acute (21-day repeated) inhalation toxicity study in male and female rats (1977): NOAEC 44.3 mg/m3No dermal studies were performed with crinipan. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c439341a-c5f9-419b-bec2-733e478ecfd0/documents/IUC5-abcecaa7-7755-4785-bd5d-c5c34b00e103_4eb92cc8-aed5-46bb-b073-9d5b39dd1163.html,,,,,, Climbazole,38083-17-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c439341a-c5f9-419b-bec2-733e478ecfd0/documents/IUC5-abcecaa7-7755-4785-bd5d-c5c34b00e103_4eb92cc8-aed5-46bb-b073-9d5b39dd1163.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,44.3 mg/m3,,rat Climbazole,38083-17-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c439341a-c5f9-419b-bec2-733e478ecfd0/documents/IUC5-abcecaa7-7755-4785-bd5d-c5c34b00e103_4eb92cc8-aed5-46bb-b073-9d5b39dd1163.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat Climbazole,38083-17-9,"Acute toxicity studies with crinipan were performed in rats (study report: Bayer/Symrise 1975039), mice (study report: Bayer/Symrise 1975038), rabbits (study report: Bayer/Symrise 1975040), and dogs (study report: Bayer/Symrise 1975039). The results clearly classify crinipan as moderately toxic with oral LD50 of 400 mg/kg bw in rats. Accordingly, the compound is classified into ‘Category 4’ according to the current EU-CLP.No study on the acute toxicity of crinipan upon dermal application was conducted. This is considered justified, since no local corrosive or irritant effects on the skin were observed after topical application of crinipan (see the corrosion/irritation section of this Technical Dossier for details), the dermal absorption of crinipan is low (see the corrosion/irritation section of this Technical Dossier for details), and crinipan is only moderately toxic following oral application (e.g., the LD50 value of crinipan in rats was determined at 400 mg/kg; see the studies on acute oral toxicity documented in this Technical Dossier for details). Accordingly, it is considered unlikely that crinipan might elicit any noteworthy degree of local or systemic toxicity following dermal application, in particular as pharmacokinetic studies showed only limited dermal penetration. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c439341a-c5f9-419b-bec2-733e478ecfd0/documents/IUC5-95e9a573-b486-4001-8c04-7e2aaa2194b9_4eb92cc8-aed5-46bb-b073-9d5b39dd1163.html,,,,,, Climbazole,38083-17-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c439341a-c5f9-419b-bec2-733e478ecfd0/documents/IUC5-95e9a573-b486-4001-8c04-7e2aaa2194b9_4eb92cc8-aed5-46bb-b073-9d5b39dd1163.html,,oral,LD50,400 mg/kg bw,adverse effect observed, Cobalt dichloride,7646-79-9,Acute oral toxicity:LD50(rat) = 537 mg cobalt dichloride hexahydrate/kg bw (Confidence interval: 479 – 601 mg/kg bw)Acute dermal toxicity:Conduct of an acute dermal toxicity study for cobalt chloride is unjustified since dermal uptake is considered negligible.Acute inhalation toxicity:The classification from the acute oral toxicity is read-across to the acute toxicity via inhalation. Further results from the ongoing testing programme will be included upon availability. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4bd551b7-9cb6-4146-88d2-b3890974ba80/documents/IUC5-58819aba-829e-4ffe-a2bd-685995991fbb_5c5a079c-6f4a-477c-88b3-3d2f1607088c.html,,,,,, Cobalt dichloride,7646-79-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4bd551b7-9cb6-4146-88d2-b3890974ba80/documents/IUC5-58819aba-829e-4ffe-a2bd-685995991fbb_5c5a079c-6f4a-477c-88b3-3d2f1607088c.html,,oral,LD50,537 mg/kg bw,adverse effect observed, "1-Propanaminium, 3-amino-N-[2-[(2-hydroxyethyl)amino]-2-oxoethyl]-N,N-dimethyl-, N-C12-18 acyl derivs., chlorides",164288-56-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca8b6e0e-1182-4cee-a2c0-1c024ac2a2f1/documents/06aad591-4bbc-4a15-bc7e-f649e96ce4cb_4e794408-0964-4755-81a7-72acaa97f4c5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "1-Propanaminium, 3-amino-N-[2-[(2-hydroxyethyl)amino]-2-oxoethyl]-N,N-dimethyl-, N-C12-18 acyl derivs., chlorides",164288-56-6,"Acute toxicity studies are performed on the notified chemical (i.e. 1-Propanaminium,3-(1-oxododecyl)-amino-N-(2-((2-hydroxyethyl)amino)-2-oxoethyl)-N,N-dimethyl) and the market name MONTALINE C 40. Either oral toxicity tests (OECD 401 and OECD 420) or dermal toxicity test (OECD 402) results in a same conclusion. The notified chemical doesn't required EU labelling (i.e. LD 50 > 2000 mg/kg).Based on this weight of evidence, the acute inhalation test is not judged redundant and not performed. The DNEL for worker is then calculated by extrapolation. The calculated values are summarised as below: ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca8b6e0e-1182-4cee-a2c0-1c024ac2a2f1/documents/IUC5-68527901-6f07-4d76-a2db-20e984ea8d9b_4e794408-0964-4755-81a7-72acaa97f4c5.html,,,,,, "1-Propanaminium, 3-amino-N-[2-[(2-hydroxyethyl)amino]-2-oxoethyl]-N,N-dimethyl-, N-C12-18 acyl derivs., chlorides",164288-56-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca8b6e0e-1182-4cee-a2c0-1c024ac2a2f1/documents/IUC5-68527901-6f07-4d76-a2db-20e984ea8d9b_4e794408-0964-4755-81a7-72acaa97f4c5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-Propanaminium, 3-amino-N-[2-[(2-hydroxyethyl)amino]-2-oxoethyl]-N,N-dimethyl-, N-C12-18 acyl derivs., chlorides",164288-56-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca8b6e0e-1182-4cee-a2c0-1c024ac2a2f1/documents/IUC5-68527901-6f07-4d76-a2db-20e984ea8d9b_4e794408-0964-4755-81a7-72acaa97f4c5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-C8-18(even numbered) acyl derivs., hydroxides, inner salts",97862-59-4,"Reliable data on repeated dose toxicity of AAPBs are available for the oral route from 28-day and 90-day gavage studies as well as from a 90-day feeding study in rats. In these studies performed according to the corresponding OECD Guidelines on C8-18 AAPB and Coco AAPB, up to and including the highest tested doses, no indication of any systemic toxicity of AAPBs relevant in view of a potential serious health risk for humans was found. NOELs derived from the 90-day gavage and the 90-day feeding study relevant in view of a potential serious health risk for humans were the highest tested doses of 300 mg a. i./kg bw/day (corresponding to 1000 mg product (a. i. ca. 30 %)/kg bw/day) and 1 % in feed (corresponding to 731 mg product/kg bw/day and 247 mg a. i./kg bw/day based on measured food consumption), respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96c9adef-d681-4fda-a78a-dcf7253b3b04/documents/IUC5-6ae2605b-6242-4ed1-ae02-448c601c9abb_7314d592-22df-4102-8637-20f6fdcb1f02.html,,,,,, "1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-C8-18(even numbered) acyl derivs., hydroxides, inner salts",97862-59-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96c9adef-d681-4fda-a78a-dcf7253b3b04/documents/IUC5-6ae2605b-6242-4ed1-ae02-448c601c9abb_7314d592-22df-4102-8637-20f6fdcb1f02.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-C8-18(even numbered) acyl derivs., hydroxides, inner salts",97862-59-4,"There is no evidence on relevant intrinsic acute toxic activity of AAPB constituting a hazard to human health. Acute toxicity data on AAPBs are available for the oral and for the dermal route. Acute animal studies by inhalation route are unjustified. Due to its very low vapour pressure, an exposure to AAPB vapour is negligible. Generation of aerosols may be theoretically possible, however the estimated exposure is very low. Furthermore, systemic toxicity relevant to humans did not appear neither in acute nor in repeated dose toxicity studies by other exposure routes. Considering the exposure probability and the available information on the intrinsic toxic activity of the substance, an inhalative risk to humans is unlikely and therefore, the conduct of an inhalative toxicity study is unjustified. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96c9adef-d681-4fda-a78a-dcf7253b3b04/documents/IUC5-d35dab19-5035-4fd1-944e-4417cdb38990_7314d592-22df-4102-8637-20f6fdcb1f02.html,,,,,, "1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-C8-18(even numbered) acyl derivs., hydroxides, inner salts",97862-59-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96c9adef-d681-4fda-a78a-dcf7253b3b04/documents/IUC5-d35dab19-5035-4fd1-944e-4417cdb38990_7314d592-22df-4102-8637-20f6fdcb1f02.html,,oral,LD50,"2,335 mg/kg bw",no adverse effect observed, "1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-C8-18(even numbered) acyl derivs., hydroxides, inner salts",97862-59-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96c9adef-d681-4fda-a78a-dcf7253b3b04/documents/IUC5-d35dab19-5035-4fd1-944e-4417cdb38990_7314d592-22df-4102-8637-20f6fdcb1f02.html,,dermal,LD50,620 mg/kg bw,no adverse effect observed, "1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts",61789-40-0,"Repeated oral toxicity: NOAEL was considered to be 500 mg/kg bw when male and female Sprague-Dawley rats were treated with test chemical orally by gavage for 28 days. Hence the test chemical is not likely to classify as repeated dose oral toxic as per the criteria mentioned in CLP regulation.   Repeated dose inhalation toxicity: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapor pressure of the test substance, which is reported as 4.60E-15 mm Hg at 25 C. Thus, exposure to inhalable dust, mist and vapor of the chemical is highly unlikely. Therefore this study is considered for waiver.   Repeated dose dermal toxicity: In accordance with column 2 of Annex IX, this end point was considered for waiver since the acute toxicity by the dermal route has already been provided in section 7.2.3 (as part of the Annex VIII information requirements). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1b1a079-4f84-4dca-82eb-0cf028af84c7/documents/378600c5-81e6-44b1-af2e-46b38d4c15e3_fe5cf51b-b302-4a36-8d04-e7f8a807b59e.html,,,,,, "1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts",61789-40-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1b1a079-4f84-4dca-82eb-0cf028af84c7/documents/378600c5-81e6-44b1-af2e-46b38d4c15e3_fe5cf51b-b302-4a36-8d04-e7f8a807b59e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts",61789-40-0," Acute oral toxicity:  Acute oral toxicity dose (LD50) of target chemical was considered based on different experimental studies conducted on rats and mice, the LD50 values were considered to be >5000 mg/kg bw in rat and 6450 mg/kg bw in mice. The studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  The given test chemical has very low vapour pressure (6.41E-13 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal Toxicity: Acute Dermal toxicity dose (LD50) for target chemical was considered based on experimental study conducted on rats, the value was considered to be >2000 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1b1a079-4f84-4dca-82eb-0cf028af84c7/documents/1bf1270a-0210-4de2-bd00-094c7bca208f_fe5cf51b-b302-4a36-8d04-e7f8a807b59e.html,,,,,, "1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts",61789-40-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1b1a079-4f84-4dca-82eb-0cf028af84c7/documents/1bf1270a-0210-4de2-bd00-094c7bca208f_fe5cf51b-b302-4a36-8d04-e7f8a807b59e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "1-Propanaminium, 3-amino-N-(carboxymethyl)-N,N-dimethyl-, N-coco acyl derivs., hydroxides, inner salts",61789-40-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1b1a079-4f84-4dca-82eb-0cf028af84c7/documents/1bf1270a-0210-4de2-bd00-094c7bca208f_fe5cf51b-b302-4a36-8d04-e7f8a807b59e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-coco acyl derivs., hydroxides, inner salts",68139-30-0," In an experimental study performed according to OECD Test Guideline 401 on a read-across substance, the oral LD50 in rats was calculated to be 3020 or 2950 mg active ingredient/kg bw, for females or both genders, respectively, at 24 hours and 14 days after administration. No deaths were observed at the lowest dose of 1000 mg/kg bw. In a supporting epxerimental study not performed according to an OECD Test Guideline, the substance itself was determined to have an oral LD50 in rats of >5000 mg/kg bw, following 3 out of 10 mortalities after 14 days exposure to doses of 5 g/kg bw. No death or ill effects were observed in the 5 male rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ab0231a-8adf-4565-b1ff-d673c8e3aac0/documents/e512c2ab-fdf4-4adc-bbe7-17c0e3ac3865_b813205c-e846-4e8c-a6f6-20cc3db701fc.html,,,,,, "Amides, coco, N-[3-(dimethylamino)propyl], N-oxides",68155-09-9," A 28-day study (OECD 407 and Eu Method B.7, GLP) was conducted (Stepan, 2000). Five Sprague-Dawley rats per sex per dose were exposed by gavage to 15, 150, and 1000 mg/kg/day of the active ingredient. 15 mg/kg/day was reported as NOEL based on liver, blood and spleen effects. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a43a7ffb-8ddb-4485-8c0e-87ddc344ed1d/documents/4a575359-083a-4200-8003-7a3b569f3135_cb2a9c1b-d859-45db-bb8b-dc3d057db0a0.html,,,,,, "Amides, coco, N-[3-(dimethylamino)propyl], N-oxides",68155-09-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a43a7ffb-8ddb-4485-8c0e-87ddc344ed1d/documents/4a575359-083a-4200-8003-7a3b569f3135_cb2a9c1b-d859-45db-bb8b-dc3d057db0a0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "Amides, coco, N-[3-(dimethylamino)propyl], N-oxides",68155-09-9," Oral: LD50 of between 500 and 1000 mg/kg. OECD 423, GLP (Stepan, 2000), Sprague-Dawley rats exposed to 200 mg/kg (only females) and 2000 mg/kg (males and females). Two animals treated with 2000 mg/kg were found dead one or two days after dosing. Necropsy results revealed dark liver and dark kidneys in the 2000 mg/kg group.  Dermal: LD50 greater than 2000 mg/kg OECD 402, GLP (Stepan, 2000), 5 Sprague-Dawley rats exposed to 2000 mg/kg. No observed mortality. In four animals, a slight brown discoloration was observed. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a43a7ffb-8ddb-4485-8c0e-87ddc344ed1d/documents/8cb08e4b-9347-4e8e-ad1d-4d5e668a00af_cb2a9c1b-d859-45db-bb8b-dc3d057db0a0.html,,,,,, "Amides, coco, N-[3-(dimethylamino)propyl], N-oxides",68155-09-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a43a7ffb-8ddb-4485-8c0e-87ddc344ed1d/documents/8cb08e4b-9347-4e8e-ad1d-4d5e668a00af_cb2a9c1b-d859-45db-bb8b-dc3d057db0a0.html,,oral,discriminating dose,500 mg/kg bw,adverse effect observed, "D-Glucopyranose, oligomeric, C10-16(even numbered) alkyl glycosides",110615-47-9,An oral subchronic repeated dose toxicity study revealed a NOAEL of 1000 mg/kg/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea98e2fb-c0c4-42f3-b3b4-812d441097a5/documents/IUC5-c087c843-900e-43e6-b46c-795538d1f5a4_1cb299eb-af87-4bae-b74a-f40031881c06.html,,,,,, "D-Glucopyranose, oligomeric, C10-16(even numbered) alkyl glycosides",110615-47-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea98e2fb-c0c4-42f3-b3b4-812d441097a5/documents/IUC5-c087c843-900e-43e6-b46c-795538d1f5a4_1cb299eb-af87-4bae-b74a-f40031881c06.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, "D-Glucopyranose, oligomeric, C10-16(even numbered) alkyl glycosides",110615-47-9,"Many high quality studies investigating the acute toxicity of APG have shown that in terms of acute toxicity the use of these compounds are of low concern. They are of low oral, dermal and inhalation toxicity. From a structural activity point of view, the length of the alkyl chain did not exert any meaningful influence on acute toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea98e2fb-c0c4-42f3-b3b4-812d441097a5/documents/IUC5-3cde2e93-88fa-4a4a-aa47-ccffe2452cdc_1cb299eb-af87-4bae-b74a-f40031881c06.html,,,,,, "D-Glucopyranose, oligomeric, C10-16(even numbered) alkyl glycosides",110615-47-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea98e2fb-c0c4-42f3-b3b4-812d441097a5/documents/IUC5-3cde2e93-88fa-4a4a-aa47-ccffe2452cdc_1cb299eb-af87-4bae-b74a-f40031881c06.html,,oral,LD50,"2,000 mg/kg bw",, "D-Glucopyranose, oligomeric, C10-16(even numbered) alkyl glycosides",110615-47-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea98e2fb-c0c4-42f3-b3b4-812d441097a5/documents/IUC5-3cde2e93-88fa-4a4a-aa47-ccffe2452cdc_1cb299eb-af87-4bae-b74a-f40031881c06.html,,dermal,LD50,"2,000 mg/kg bw",, "Imidazolium compounds, 1-[2-(2-carboxyethoxy)ethyl]-1(or 3)-(2-carboxyethyl)-4,5-dihydro-2-norcoco alkyl",68919-40-4," Based on a LD50 oral in mice of 9800 mg/kg bw, the registered substance is not classified for acute oral toxicity according to CLP and GHS UN criteria. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52e8fa48-8f1b-4b51-96c9-c72a614c3b4c/documents/23dc08cd-b106-4100-b8c2-6d70f5b0c9aa_0f36c047-7f24-4781-a03a-82eb7789977e.html,,,,,, "Imidazolium compounds, 1-[2-(2-carboxyethoxy)ethyl]-1(or 3)-(2-carboxyethyl)-4,5-dihydro-2-norcoco alkyl",68919-40-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52e8fa48-8f1b-4b51-96c9-c72a614c3b4c/documents/23dc08cd-b106-4100-b8c2-6d70f5b0c9aa_0f36c047-7f24-4781-a03a-82eb7789977e.html,,oral,LD50,"9,800 mg/kg bw",no adverse effect observed, "Quaternary ammonium compounds, coco alkyltrimethyl, chlorides",61789-18-2," Overall, considering the repeated dose studies with the test substance and read across substance (C16 TMAB and C16 TMAC) the main critical effects associated with these substances were due to their corrosive properties. The systemic effects such as the reduction of body weight and food consumption were considered to be secondary compared to the corrosive properties of the substances. Therefore, in the absence of ‘true’ systemic effects and in line with the biocides assessment reports, the derivation of a systemic DNEL has been considered to be non-relevant and only a qualitative local risk assessment has been conducted for the test substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbb10cc5-8ca5-4491-b14b-22482449bd52/documents/a70057f5-26ed-4b6e-8d9f-b3d84e46f23e_b254bb30-fffc-4988-ac7b-8dc984ab5f2f.html,,,,,, "Quaternary ammonium compounds, coco alkyltrimethyl, chlorides",61789-18-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbb10cc5-8ca5-4491-b14b-22482449bd52/documents/a70057f5-26ed-4b6e-8d9f-b3d84e46f23e_b254bb30-fffc-4988-ac7b-8dc984ab5f2f.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rabbit "Quaternary ammonium compounds, coco alkyltrimethyl, chlorides",61789-18-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbb10cc5-8ca5-4491-b14b-22482449bd52/documents/a70057f5-26ed-4b6e-8d9f-b3d84e46f23e_b254bb30-fffc-4988-ac7b-8dc984ab5f2f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40.3 mg/kg bw/day,,rat "Quaternary ammonium compounds, coco alkyltrimethyl, chlorides",61789-18-2,"In line with the biocides assessment report, the oral and dermal LD50 values of the test substance was considered to be at 207 and 429 mg a.i./kg bw respectively, suggesting of moderate acute toxicity potential. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbb10cc5-8ca5-4491-b14b-22482449bd52/documents/33e6255d-7de4-45ee-a4aa-49383c31af28_b254bb30-fffc-4988-ac7b-8dc984ab5f2f.html,,,,,, "Quaternary ammonium compounds, coco alkyltrimethyl, chlorides",61789-18-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbb10cc5-8ca5-4491-b14b-22482449bd52/documents/33e6255d-7de4-45ee-a4aa-49383c31af28_b254bb30-fffc-4988-ac7b-8dc984ab5f2f.html,,oral,LD50,207 mg/kg bw,adverse effect observed, "Quaternary ammonium compounds, coco alkyltrimethyl, chlorides",61789-18-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbb10cc5-8ca5-4491-b14b-22482449bd52/documents/33e6255d-7de4-45ee-a4aa-49383c31af28_b254bb30-fffc-4988-ac7b-8dc984ab5f2f.html,,dermal,LD50,429 mg/kg bw,adverse effect observed, "Glycine, N-methyl-, N-coco acyl derivs.",68411-97-2," Repeated dose toxicity - oral (no OECD, 2-year study), rat: NOAEL ≥ 1000 mg/kg bw/day Repeated dose toxicity - oral (OECD 408, 90-day), rat: NOAEL ≥ 250 mg/kg bw/day RA from source substance Sodium N-lauroylsarcosinate (CAS 137-16-6) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d71341b5-8f31-4be5-bf63-fb290c20e0b4/documents/96288f21-8f21-44e8-baf3-8a324baa177f_14fec790-2ac2-4881-bb3d-abc8f9d184d0.html,,,,,, "Glycine, N-methyl-, N-coco acyl derivs.",68411-97-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d71341b5-8f31-4be5-bf63-fb290c20e0b4/documents/96288f21-8f21-44e8-baf3-8a324baa177f_14fec790-2ac2-4881-bb3d-abc8f9d184d0.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Glycine, N-methyl-, N-coco acyl derivs.",68411-97-2," Oral: Data waiving Inhalation: Data waiving Dermal: Data waiving As the registered substance is classified for its skin corrosion properties as Skin Corr. 1B (H314), no acute toxicity studies have to be conducted according to Regulation (EC) No. 1907/2006 (REACH), Annexes VII and VIII, Item 8.5, Column 2. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d71341b5-8f31-4be5-bf63-fb290c20e0b4/documents/108a625a-af5e-41cf-89b7-142d4472bf05_14fec790-2ac2-4881-bb3d-abc8f9d184d0.html,,,,,, Diamond,7782-40-3,Diamond is not bioavailable (and not systemically available) and therefore not acute toxic. Limit tests on oral and dermal toxicity resulted in LD50 values > 2000 mg/kg bw. Diamond was further not toxic in an inhalation study (5.20 mg/L). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/350a3a34-43d0-48ff-a48c-a490ed5dad47/documents/IUC5-908e40d3-4eaf-4bd8-9ef5-ad4258800db6_af3080f1-ec03-4c53-b8e4-448780e5c4ea.html,,,,,, Diamond,7782-40-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/350a3a34-43d0-48ff-a48c-a490ed5dad47/documents/IUC5-908e40d3-4eaf-4bd8-9ef5-ad4258800db6_af3080f1-ec03-4c53-b8e4-448780e5c4ea.html,,oral,LD50,"2,000 mg/kg bw",, Diamond,7782-40-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/350a3a34-43d0-48ff-a48c-a490ed5dad47/documents/IUC5-908e40d3-4eaf-4bd8-9ef5-ad4258800db6_af3080f1-ec03-4c53-b8e4-448780e5c4ea.html,,dermal,LD50,"2,000 mg/kg bw",, Diamond,7782-40-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/350a3a34-43d0-48ff-a48c-a490ed5dad47/documents/IUC5-908e40d3-4eaf-4bd8-9ef5-ad4258800db6_af3080f1-ec03-4c53-b8e4-448780e5c4ea.html,,inhalation,LC50,5.2 mg/m3,, Palladium,7440-05-3," No relevant repeated dose toxicity data were identified for palladium.   Palladium is considered to fall within the scope of the read-across category 'Palladium, Palladium monoxide and palladium dihydroxide'. In an OECD Test Guideline 422 combined repeated dose and reproductive/developmental toxicity screening study in rats, involving the gavage administration of palladium dihydroxide for at least 28 days, the systemic NOAEL was the highest tested dose (1000 mg/kg bw/day). Although some treatment related microscopic findings (mucosal discoloration in the non-glandular stomach, ileum, cecum, colon and/or rectum) were noted at dose levels of 300 and 1000 mg/kg bw/day, these were considered to result from direct (local) contact with the test substance rather than systemic toxicity (Török-Bathó, 2015). The oral NOAEL for palladium dihydroxide (1000 mg/kg bw/day) equates to an NOAEL of 758 mg/kg bw/day for palladium (based on MWt ratio). No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Overall, good-quality database which meets REACH Standard Information Requirements. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c8c1aa5-c8f1-40a3-992b-5a210de0ccac/documents/IUC5-794b34e1-3d3c-4b14-9f80-2e8fc5ba91b3_28fd4b1c-adae-4735-a1a3-972dc0b61ce7.html,,,,,, Palladium,7440-05-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c8c1aa5-c8f1-40a3-992b-5a210de0ccac/documents/IUC5-794b34e1-3d3c-4b14-9f80-2e8fc5ba91b3_28fd4b1c-adae-4735-a1a3-972dc0b61ce7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Palladium,7440-05-3," No relevant acute oral, dermal or inhalation toxicity data were identified with palladium.The substance is considered to fall withing the scope of the read-across category 'Palladium, palladium monoxide and Palladium dihydroxide'. In an acute oral toxicity study, groups of male Sprague-Dawley rats were administered palladium monoxide by stomach tube and observed for 14 days. Using the prescribed statistical method, the acute oral median lethal dose (LD50) was found to exceed 4.9 g/kg bw. Via a weight-of-evidence argumentation, the registrants consider it justified to avoid in vivo testing for acute toxicity(oral) for this substance (as exemplified in ECHA Guidance R.7a Figure 7.4-4) and consider the substance of low acute hazard via the oral route with an assumed LD50>2000 mg/kg(bw). Based on this experimental evidence, palladium is considered to have an LD50>2000 mg/kg(bw). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c8c1aa5-c8f1-40a3-992b-5a210de0ccac/documents/IUC5-6a5abb65-8b06-4025-ad3b-56b432702147_28fd4b1c-adae-4735-a1a3-972dc0b61ce7.html,,,,,, Palladium,7440-05-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c8c1aa5-c8f1-40a3-992b-5a210de0ccac/documents/IUC5-6a5abb65-8b06-4025-ad3b-56b432702147_28fd4b1c-adae-4735-a1a3-972dc0b61ce7.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Platinum,7440-06-4, No relevant repeated dose toxicity data were identified. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8232c32-b219-4b61-8411-2d9a2a358ab5/documents/ad2f2be7-492a-43ab-84e9-aaa19b9aa8c5_faafd0de-3ac1-437a-9894-442fefaf0237.html,,,,,, Platinum,7440-06-4," No relevant acute oral, dermal or inhalation toxicity data were identified. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8232c32-b219-4b61-8411-2d9a2a358ab5/documents/930e9487-ee3a-432b-98f3-dc6e37a78b49_faafd0de-3ac1-437a-9894-442fefaf0237.html,,,,,, Sulfur,7704-34-9,"Sulfur did not induce toxicity in an oral 28 day or an oral 90 day toxicity study up to 1000 mg/kg bw/day.Regarding dermal exposure, no systemic toxicity was observed up to 1000 mg/kg bw/day in a 28 day study. For dermal local effects, a NOAEL of 400 mg/kg bw/day was derived based on a higher incidence of hyperkeratosis in the treated skin (treatment related and reversible). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3467c49-de17-4683-a079-f08d079951a7/documents/fd7ae448-fbbf-45e4-8611-aef93a9c33de_1c8e1c9a-26c1-460d-8e2d-269b1f81f500.html,,,,,, Sulfur,7704-34-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3467c49-de17-4683-a079-f08d079951a7/documents/fd7ae448-fbbf-45e4-8611-aef93a9c33de_1c8e1c9a-26c1-460d-8e2d-269b1f81f500.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat Sulfur,7704-34-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3467c49-de17-4683-a079-f08d079951a7/documents/fd7ae448-fbbf-45e4-8611-aef93a9c33de_1c8e1c9a-26c1-460d-8e2d-269b1f81f500.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sulfur,7704-34-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3467c49-de17-4683-a079-f08d079951a7/documents/fd7ae448-fbbf-45e4-8611-aef93a9c33de_1c8e1c9a-26c1-460d-8e2d-269b1f81f500.html,Repeated dose toxicity – local effects,dermal,NOAEL,400 ,adverse effect observed,rat Sulfur,7704-34-9,The acute oral and dermal LD50 values of sulfur are higher than 2000 mg/kg bw. The acute inhalation LC50 is higher than 5.43 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3467c49-de17-4683-a079-f08d079951a7/documents/7abb2540-04b2-425d-9ea1-0eb00e1f3d95_1c8e1c9a-26c1-460d-8e2d-269b1f81f500.html,,,,,, Sulfur,7704-34-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3467c49-de17-4683-a079-f08d079951a7/documents/7abb2540-04b2-425d-9ea1-0eb00e1f3d95_1c8e1c9a-26c1-460d-8e2d-269b1f81f500.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sulfur,7704-34-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3467c49-de17-4683-a079-f08d079951a7/documents/7abb2540-04b2-425d-9ea1-0eb00e1f3d95_1c8e1c9a-26c1-460d-8e2d-269b1f81f500.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sulfur,7704-34-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3467c49-de17-4683-a079-f08d079951a7/documents/7abb2540-04b2-425d-9ea1-0eb00e1f3d95_1c8e1c9a-26c1-460d-8e2d-269b1f81f500.html,,inhalation,LC50,"5,430 mg/m3",no adverse effect observed, Rosin,8050-09-7," Several key guideline (OECD 408, 414, 421, & 422 ) studies that investigated the repeated dose toxicity potential of Rosin; Rosin, hydrogenated; Rosin, oligomers; and Rosin, reaction products with formaldehyde following oral dietary exposure in rats are available. The results are summarized below: OECD 408 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL was determined to be 5000 ppm (equivalent to a mean achieved dosage of 335.2 mg/kg bw/day for males and 401.2 mg/kg bw/day for females) based on reduced body weight gains in animals of either sex exposed to 7500 ppm. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The NOAEL for systemic toxicity of Rosin, reaction products with formaldehyde was considered to be 3000 ppm (equivalent to mean achieved dosages of approximately 213.1 mg/kg bw/day or 255.2 mg/kg bw/day for males and females, respectively), based on the effects on body weight, body weight gain and, to a lesser extent, food consumption, observed among females exposed to diets containing 7500 ppm of the test material for ninety days. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): Based on a lack of adverse treatment-related effects observed at the highest concentration tested, the systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 6000 ppm for either sex (equivalent to a mean achieved dosage of 334.5 mg/kg bw/day for males and 399.8 mg/kg bw/day for females). OECD 414 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 2500 ppm (equivalent to a mean achieved dosage of 199.3 mg/kg bw/day) based on lower maternal body weight gain during gestation and an initial effect on food consumption at 7500 ppm and lower maternal body weight gain at 5000 ppm. OECD 421 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 1000 ppm in males (equivalent to 84 mg/kg bw/d) and 3000 ppm in females (equivalent to 309 mg/kg bw/d) based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material. OECD 422 1) Rosin (CAS# 8050 -09 -7): In a key combined repeated dose, reproductive/developmental toxicity screening study (Harlan Laboratories Ltd, 2015a), the sytemic toxicity NOAEL for Tall oil rosin was determined to be 5000 ppm. In another key combined repeated dose, reproductive/developmental toxicity study (Harlan Laboratories Ltd., 2014a), the systemic toxicity NOAEL for Gum Rosin was determined to be 2500 ppm. A NOEL (No Observed Effect Level) for general toxicity could not be established due to effects on body weights at all dose levels in females during the lactation period. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The systemic toxicity NOAEL for Rosin, reaction product with formaldehyde was determined to be 10000 ppm and the NOEL was established at a concentration of 1000 ppm. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): The systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 3000 ppm. Based on the histopathological changes observed in adrenal glands, no NOEL for systemic toxicity was established for females whereas for males it was at the dose level of 1000 ppm. 4) Rosin, oligomers: The systemic toxicity NOAEL for Rosin, oligomers in male rats was determined to be 7500 ppm, based on statistically significant body weight and body weight gain effects observed at the 15000 ppm concentration level. The systemic toxicity NOAEL for female rats was determined to be 3000 ppm, based on effects on body weight and body weight gain in females exposed to the test material at 7500 and 15000 ppm. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efbf0b48-2500-40e2-bf3a-cf34f56f55ae/documents/e60a7c54-109e-4a58-a8f2-cda7c1e09856_5fb1abc0-9cf3-431c-a93c-f2a0b6ec742b.html,,,,,, Rosin,8050-09-7,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efbf0b48-2500-40e2-bf3a-cf34f56f55ae/documents/30876267-d418-4f04-976c-90cc762c06e2_5fb1abc0-9cf3-431c-a93c-f2a0b6ec742b.html,,,,,, Rosin,8050-09-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efbf0b48-2500-40e2-bf3a-cf34f56f55ae/documents/30876267-d418-4f04-976c-90cc762c06e2_5fb1abc0-9cf3-431c-a93c-f2a0b6ec742b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Rosin,8050-09-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efbf0b48-2500-40e2-bf3a-cf34f56f55ae/documents/30876267-d418-4f04-976c-90cc762c06e2_5fb1abc0-9cf3-431c-a93c-f2a0b6ec742b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Commiphora myrrha, ext.",84929-26-0," In an acute oral toxicity study (limit test), ten rats were given  2050, 2560, 3200 and 5000 mg/kg bw/day and 5 rats were given 1050 and 1640 mg/kg bw/day of Myrrh oil . Animals were observed for mortality and clinical signs for 14 days. In this study, the oral LD50 is 1650 mg/kg bw in rats. Under the experimental conditions of this study, the test substance is classified Acute tox 4 (H302) according to Regulation (EC) No. 1272/2008 (CLP) and to GHS ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a5c899d-ae81-4a16-8e1d-0908ee4a3b39/documents/60dcc629-9f6f-4322-b86c-ef4189a52a9a_b5fc4cf8-5817-4779-b4e6-7860cbf4653a.html,,,,,, "Commiphora myrrha, ext.",84929-26-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a5c899d-ae81-4a16-8e1d-0908ee4a3b39/documents/60dcc629-9f6f-4322-b86c-ef4189a52a9a_b5fc4cf8-5817-4779-b4e6-7860cbf4653a.html,,oral,LD50,"1,650 mg/kg bw",adverse effect observed, Copper(II) carbonate-copper(II) hydroxide (1:1),12069-69-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f62c8ca-1713-481e-9db1-b7e4b88ca7f4/documents/e1f453cb-4e6f-49b0-b8fd-58a463907798_d7954f59-d710-4456-8105-ec4633e7b2fc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat Copper di-D-gluconate,527-09-3, LOAEL= 94.7 mg/kg bw/day (QSAR prediction). ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2648ac9-1928-45f0-b4c8-69272373fbf9/documents/72a11233-9736-45b2-baa4-0cb5cfe505f1_ff056450-55e6-4650-80a0-f353a06495bc.html,,,,,, Copper di-D-gluconate,527-09-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2648ac9-1928-45f0-b4c8-69272373fbf9/documents/72a11233-9736-45b2-baa4-0cb5cfe505f1_ff056450-55e6-4650-80a0-f353a06495bc.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,94.7 mg/kg bw/day,, Copper di-D-gluconate,527-09-3," DL50 (Oral): 1709 mg/kg bw; OECD 401 DL50 (Dermal): 2130 mg/kg bw; QSAR prediction CL50 (inhalation): in accordance with column 2 of REACH Annex VIII, the study does not need to be conducted since exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or dorplets of an inhalable size. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2648ac9-1928-45f0-b4c8-69272373fbf9/documents/47e03f2b-e616-40ef-9b1c-1d20d110d64e_ff056450-55e6-4650-80a0-f353a06495bc.html,,,,,, Copper di-D-gluconate,527-09-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2648ac9-1928-45f0-b4c8-69272373fbf9/documents/47e03f2b-e616-40ef-9b1c-1d20d110d64e_ff056450-55e6-4650-80a0-f353a06495bc.html,,oral,LD50,"1,709 mg/kg bw",adverse effect observed, Copper di-D-gluconate,527-09-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2648ac9-1928-45f0-b4c8-69272373fbf9/documents/47e03f2b-e616-40ef-9b1c-1d20d110d64e_ff056450-55e6-4650-80a0-f353a06495bc.html,,dermal,LD50,"2,130 mg/kg bw",no adverse effect observed, Copper glycinate,32817-15-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba0a9e55-9d9f-484a-b203-03f02c57679d/documents/3e8dbfb3-07a7-4bdd-8cd4-00d2c9e89b2d_29ed3bac-d8d0-4950-ba54-8386d293bb5f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,2.5 mg/m3,no adverse effect observed, Copper glycinate,32817-15-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba0a9e55-9d9f-484a-b203-03f02c57679d/documents/7347097e-7fb5-4d07-8e79-fac97dc0e899_29ed3bac-d8d0-4950-ba54-8386d293bb5f.html,,oral,LD50,481 mg/kg bw,adverse effect observed, Copper glycinate,32817-15-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba0a9e55-9d9f-484a-b203-03f02c57679d/documents/7347097e-7fb5-4d07-8e79-fac97dc0e899_29ed3bac-d8d0-4950-ba54-8386d293bb5f.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, Copper glycinate,32817-15-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba0a9e55-9d9f-484a-b203-03f02c57679d/documents/7347097e-7fb5-4d07-8e79-fac97dc0e899_29ed3bac-d8d0-4950-ba54-8386d293bb5f.html,,inhalation,LC50,"4,450 mg/m3",adverse effect observed, Copper sulphate,7758-98-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd9c4cf5-346b-47c9-892a-778eb7ba7a74/documents/55aac19e-e536-4cf3-b1d4-f3845f57f888_4a720c85-8ba4-44d7-99a8-68556d5a3902.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat "Coriander, ext.",84775-50-8,"In an acute oral toxicity study, the oral LD50 of test item was 3588 mg/kg bw in rats (Rel. K2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5128c28-bea9-4cb8-ba38-6c4a03e6729d/documents/dfbce3f7-0306-48f3-9a22-179d48193c03_3dcfabae-6bbb-4867-88da-0d37bec8fe75.html,,,,,, "Coriander, ext.",84775-50-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5128c28-bea9-4cb8-ba38-6c4a03e6729d/documents/dfbce3f7-0306-48f3-9a22-179d48193c03_3dcfabae-6bbb-4867-88da-0d37bec8fe75.html,,oral,LD50,"3,588 mg/kg bw",adverse effect observed, Coumarin,91-64-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable because all data come from RIFM database. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa3d9dd3-52df-4d60-9898-c89420fc1862/documents/IUC5-a274967e-d8af-4344-9817-d3616507aa45_0884dc4a-47b3-4ca9-bd4c-677a45a13111.html,,,,,, Coumarin,91-64-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa3d9dd3-52df-4d60-9898-c89420fc1862/documents/IUC5-a274967e-d8af-4344-9817-d3616507aa45_0884dc4a-47b3-4ca9-bd4c-677a45a13111.html,,oral,LD50,520 mg/kg bw,adverse effect observed, N-amidinosarcosine,57-00-1," There are several studies in the animal model and clinical and case studies in humans available on the effects of long-term supplementation of Creatine (Monohydrate) (see IUCLID section 7.10.5). Among them a subacute oral toxicity (28-day) according OECD guideline 407, the corresponding dose-range finding study, a subacute oral toxicity study (42 days) in rats with the cystic kidney disease and two clilnical trials by Kreider et al (2003) and Gualano et al (2008). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9801808-39de-4603-827d-6b4e208f7de1/documents/ba49c296-36d7-441a-bbe8-f413ed28cacf_d51933a9-b3db-41d2-914c-dc7a316a6f22.html,,,,,, N-amidinosarcosine,57-00-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9801808-39de-4603-827d-6b4e208f7de1/documents/ba49c296-36d7-441a-bbe8-f413ed28cacf_d51933a9-b3db-41d2-914c-dc7a316a6f22.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,758.36 mg/kg bw/day",,rat N-amidinosarcosine,57-00-1," Four reliable acute toxicity studies on Creatine monohydrate are available. Two oral studies in rats, one dermal study in the rat and one intraperitoneal study in mice. All studies are indicating no acute effect up to 2000 mg/kg body weight. A LD50 exceeding 2000 mg/kg body weight could be established. The corresponding calculated LD50 of creatine is exceeding 1758.36 mg/kg body weight. As none of the animals died during the studies the LD0 of creatine is exceeding 1758.36 mg/kg body weight. Therefore the LD50 of Creatine is expected to be above 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9801808-39de-4603-827d-6b4e208f7de1/documents/52c031a0-25cc-4a81-bef6-d1e11cd9d690_d51933a9-b3db-41d2-914c-dc7a316a6f22.html,,,,,, N-amidinosarcosine,57-00-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9801808-39de-4603-827d-6b4e208f7de1/documents/52c031a0-25cc-4a81-bef6-d1e11cd9d690_d51933a9-b3db-41d2-914c-dc7a316a6f22.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, N-amidinosarcosine,57-00-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9801808-39de-4603-827d-6b4e208f7de1/documents/52c031a0-25cc-4a81-bef6-d1e11cd9d690_d51933a9-b3db-41d2-914c-dc7a316a6f22.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, p-tolyl acetate,140-39-6," The repeated dose toxicity study was predicted using OECD QSAR toolbox version 3.3 (2017) with log kow as the primary descriptor and considering the six closest read across substances; to evaluate the toxic effects of administration of p-tolyl acetate (CAS No. 140-39-6) in rats by the oral route in a 13 weeks of exposure. No adverse effects were observed. Therefore, the no-observed adverse effect level (NOAEL) of p-tolyl acetate (CAS No. 140-39-6) in rat was estimated to be 610.66 mg/kg bw/day. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5968d2ba-1ff8-419f-aa66-9bf80be8467b/documents/91e617e2-3ba3-4828-a0d1-60524c44a158_7b27935b-5c71-4f3f-979c-b2ff762e1b7d.html,,,,,, p-tolyl acetate,140-39-6,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5968d2ba-1ff8-419f-aa66-9bf80be8467b/documents/91e617e2-3ba3-4828-a0d1-60524c44a158_7b27935b-5c71-4f3f-979c-b2ff762e1b7d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,610.66 mg/kg bw/day,,rat p-tolyl acetate,140-39-6, The substance p-tolyl acetate is likely to be hazardous by oral route and non hazardous by dermal route of exposure. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5968d2ba-1ff8-419f-aa66-9bf80be8467b/documents/4626e71f-4bef-40bd-a5b6-6c1d1019b06a_7b27935b-5c71-4f3f-979c-b2ff762e1b7d.html,,,,,, p-tolyl acetate,140-39-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5968d2ba-1ff8-419f-aa66-9bf80be8467b/documents/4626e71f-4bef-40bd-a5b6-6c1d1019b06a_7b27935b-5c71-4f3f-979c-b2ff762e1b7d.html,,oral,LD50,"1,900 mg/kg bw",adverse effect observed, p-tolyl acetate,140-39-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5968d2ba-1ff8-419f-aa66-9bf80be8467b/documents/4626e71f-4bef-40bd-a5b6-6c1d1019b06a_7b27935b-5c71-4f3f-979c-b2ff762e1b7d.html,,dermal,LD50,"2,100 mg/kg bw",no adverse effect observed, Crotonaldehyde,4170-30-3,Oral gavage (90 days) resulted in irritancy related effects at 5 mg/kg bw and above in rats. Nasal lesions in the form of acute irritation were observed in females at the 5 mg/kg bw. Oral feed in rats (14 days) did not result in any systemic or irritancy effects at the highest dose tested (175 mg/kg bw). ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e25f1c6a-8c78-4b44-a640-7323c1cb2f09/documents/IUC5-14688ad5-070d-4637-9642-e991d22909bf_4f027b66-2525-4139-b130-a82ac4ecffd5.html,,,,,, Crotonaldehyde,4170-30-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e25f1c6a-8c78-4b44-a640-7323c1cb2f09/documents/IUC5-14688ad5-070d-4637-9642-e991d22909bf_4f027b66-2525-4139-b130-a82ac4ecffd5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,, Crotonaldehyde,4170-30-3,Acute oral LD50 rats: 174 mg/kgAcute dermal LD50 in guinea pigs: 26 mg/kgAcute inhalation LC50 in rats (4 hour): 120 ppm (336 mg/m3) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e25f1c6a-8c78-4b44-a640-7323c1cb2f09/documents/IUC5-01326f2c-0112-4857-937a-2f7f621e3195_4f027b66-2525-4139-b130-a82ac4ecffd5.html,,,,,, Crotonaldehyde,4170-30-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e25f1c6a-8c78-4b44-a640-7323c1cb2f09/documents/IUC5-01326f2c-0112-4857-937a-2f7f621e3195_4f027b66-2525-4139-b130-a82ac4ecffd5.html,,oral,LD50,174 mg/kg bw,, Crotonaldehyde,4170-30-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e25f1c6a-8c78-4b44-a640-7323c1cb2f09/documents/IUC5-01326f2c-0112-4857-937a-2f7f621e3195_4f027b66-2525-4139-b130-a82ac4ecffd5.html,,dermal,LD50,26 mg/kg bw,, Crotonaldehyde,4170-30-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e25f1c6a-8c78-4b44-a640-7323c1cb2f09/documents/IUC5-01326f2c-0112-4857-937a-2f7f621e3195_4f027b66-2525-4139-b130-a82ac4ecffd5.html,,inhalation,LC50,336 mg/m3,, "Cypress, Cupressus funebris, ext.",85085-29-6, Acute oral toxicity (method similar to OECD TG 401): LD50 >5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c039076-3946-4385-a793-7bcb7d9607f0/documents/901a3e3b-d010-4077-9b6f-c004c8ce3d4d_a82ab51f-5756-48e6-aa41-5b7e4e612112.html,,,,,, "Cypress, Cupressus sempervirens, ext.",84696-07-1,"Acute toxicity, oral: LD50 (rat) > 5000 mg/kg bw (K, Rel.2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c49ce0d0-75e6-4f80-b897-ac1b45f2d87a/documents/IUC5-07415d7b-2d94-4226-a853-0eebf51d0446_b283f4fa-f1e8-4552-b556-53c69d0b8e8e.html,,,,,, "Cypress, Cupressus sempervirens, ext.",84696-07-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c49ce0d0-75e6-4f80-b897-ac1b45f2d87a/documents/IUC5-07415d7b-2d94-4226-a853-0eebf51d0446_b283f4fa-f1e8-4552-b556-53c69d0b8e8e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Copper di(acetate),142-71-2,"The pivotal repeat dose study was a 90-day study by the oral route with copper sulphate pentahydrate. In rats and mice, ingestion of copper sulphate pentahydrate produced forestomach lesions that could be to the irritant effects of the compound. The NOAEL for this effect was 16.7 mg Cu/kg bw/day in rats and 97 and 126 mg Cu/kg bw/day in male and female mice respectively. In rats inflammation of the liver was observed. The NOAEL’s for liver and kidney damage were 16.7 mg Cu/kg bw/day in rats. This is the pivotal study and the NOAEL of 16.7 mg Cu/kg bw/day will be used in the risk characterisation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ddfae21c-20fa-4e40-9435-86f4ba96a955/documents/348bb370-3036-42bd-8557-20a1f6a942aa_44aceaa4-c59f-4aef-8438-5c795a322013.html,,,,,, Copper di(acetate),142-71-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ddfae21c-20fa-4e40-9435-86f4ba96a955/documents/348bb370-3036-42bd-8557-20a1f6a942aa_44aceaa4-c59f-4aef-8438-5c795a322013.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat Copper dichloride,7447-39-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab180fd1-3e29-4f75-98c0-525bb99d1fbb/documents/7bf519d5-8272-4ea8-9fe5-34529794f670_ed251c4d-b167-4e3f-853b-531548cd6341.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat Copper oxide,1317-38-0,"The pivotal repeat dose study was a 90-day study by the oral route with copper sulphate pentahydrate. In rats and mice, ingestion of copper sulphate pentahydrate produced forestomach lesions that could be to the irritant effects of the compound. The NOAEL for this effect was 16.7 mg Cu/kg bw/day in rats and 97 and 126 mg Cu/kg bw/day in male and female mice respectively. In rats inflammation of the liver was observed. The NOAEL’s for liver and kidney damage were 16.7 mg Cu/kg bw/day in rats. This is the pivotal study and the NOAEL of 16.7 mg Cu/kg bw/day will be used in the risk characterisation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c525a13-c92a-4037-ad11-6787389cf468/documents/71ec53b0-e15a-48d6-b12e-a0ccca8b914d_44379021-25ff-48a1-966a-a5b789391742.html,,,,,, Copper oxide,1317-38-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c525a13-c92a-4037-ad11-6787389cf468/documents/71ec53b0-e15a-48d6-b12e-a0ccca8b914d_44379021-25ff-48a1-966a-a5b789391742.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat Dicopper oxide,1317-39-1,"The pivotal repeat dose study was a 90-day study by the oral route with copper sulphate pentahydrate. In rats and mice, ingestion of copper sulphate pentahydrate produced forestomach lesions that could be to the irritant effects of the compound. The NOAEL for this effect was 16.7 mg Cu/kg bw/day in rats and 97 and 126 mg Cu/kg bw/day in male and female mice respectively. In rats inflammation of the liver was observed. The NOAEL’s for liver and kidney damage were 16.7 mg Cu/kg bw/day in rats. This is the pivotal study and the NOAEL of 16.7 mg Cu/kg bw/day will be used in the risk characterisation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d5f4550a-b635-4f4e-9489-3e6c88b539f4/documents/6d1efd7e-bf49-41a7-9fe9-04a020e2e4d2_c1334150-1875-4603-bfae-83033d39a189.html,,,,,, Dicopper oxide,1317-39-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d5f4550a-b635-4f4e-9489-3e6c88b539f4/documents/6d1efd7e-bf49-41a7-9fe9-04a020e2e4d2_c1334150-1875-4603-bfae-83033d39a189.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat Cyanocobalamin,68-19-9,key study: There is a slight dose-related antinociceptive effect for cyanocobalamin at high dose levels in the writhing reaction test. No toxic effects were observed at any dose level tested orally. The NOAEL was determined to be ≥ 5620 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/288436cb-b45d-47f1-af6e-e637bf9e5202/documents/IUC5-ee540620-6d8a-4ea3-b6f0-270056ad36a3_b5fccddd-9410-4adb-90ff-79db65fd1ed0.html,,,,,, Cyanocobalamin,68-19-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/288436cb-b45d-47f1-af6e-e637bf9e5202/documents/IUC5-ee540620-6d8a-4ea3-b6f0-270056ad36a3_b5fccddd-9410-4adb-90ff-79db65fd1ed0.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,"5,620 mg/kg bw/day",,mouse Cyanocobalamin,68-19-9,Acute toxicity (oral):Supporting study: Only few data on test method reported. No toxic effects were observed for the test substance up to a dose level of 5000 mg/kg bw/day. Acute toxicity (other routes):Supporting study: No guideline was followed. Only few data on test method reported. The intraperitoneal and subcutaneous LD100 of Vitamin B12 is determined to be 3 mg/kg. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/288436cb-b45d-47f1-af6e-e637bf9e5202/documents/IUC5-d0b8063c-7253-4441-8d59-4fdfdce43356_b5fccddd-9410-4adb-90ff-79db65fd1ed0.html,,,,,, Cyanocobalamin,68-19-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/288436cb-b45d-47f1-af6e-e637bf9e5202/documents/IUC5-d0b8063c-7253-4441-8d59-4fdfdce43356_b5fccddd-9410-4adb-90ff-79db65fd1ed0.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, 3-p-cumenyl-2-methylpropionaldehyde,103-95-7," Oral studies in different species: 28-day study (rats): A 28 days range finder study was performed on Cyclamen Aldehyde (CA) prior to a 90 days sub-chronic toxicity study required by ECHA (ECHA, 2017). Animals were evaluated after necropsy for sperm parameters. Serum samples and tissue samples were preserved for additional analytical investigations. Male animals (n = 5 per group) were treated for 28 days by oral gavage with 0, 30, 100 and 300 mg/kg bw/d. No mortality, toxicologically relevant clinical signs nor any effects on food consumption were observed up to 300 mg/kg bw/d. At 100 mg/kg bw/d, adverse test item-related reduction of motile sperms, progressive sperm and number of cells with a normal morphology was noted . In addition, increased number of spermatocytes with a detached head/abnormal neck and decreased number of cells with a coiled tail were noted. However, these effects on spermatogenesis at the mid dose did not reach statistical significance and no gross lesions or correlating histopathological effects in the testis were noted. At 300 mg/kg/d, adverse lower body weight and body weight gain were observed starting in the first week of dosing. At histopathological examination of the testis, adverse degeneration of elongating spermatids and spermatid retention was observed in all males. Statistically highly significant reduction of the percentage of motile (-77.8%) and progressive sperms (-91%) and of sperms with normal morphology (-97%) was observed. Total sperm numbers were also significantly affected at this concentration (-39%) (Figure 1). Thus the LOAL for male reproductive toxicity was at 100 mg/kg bw/d based on the directional effects and 300 mg/kg bw/d for the statistically significant effects with treatment for 28 days. 90 -day Study (rats): A 90-day subchronic toxicity study in rats was requested by ECHA upon review of the Cycalmen Aldehyde submission, despite the availability of a one-generation study with prolonged treatment. It was conducted under GLP according to the OECD guideline 408 (OECD, 2018) with four groups of each 10 animals per sex dosed daily by oral gavage with 0, 15, 30 and 120 mg/kg bw/d of CA.At the tope dose of 120 mg/kg bw/d, statistically highly significant reduction (p< 0.01) of the percentage of motile (-55%) and progressive sperms (-76%) and of sperms with normal morphology (-73%) was observed . Total sperm numbers were also reduced at this concentration (-29%), while no statistically significant effects were noted at the mid and low dose (15 and 30 mg/kg bw/d). These sperm effects correlated to lower weight of the epididymides and sperm granulomas and were considered to be adverse. Thus the LOAL for male reproductive effects was at 120 mg/kg bw/d upon this prolonged treatment duration. In the liver, hepatocellular hypertrophy was noted in males starting at 30 mg/kg/d and in females starting at 15 mg/kg/d, which correlated with higher liver weight. However, the hypertrophy was without any changes in liver enzyme activity or significant morphologic degenerative changes microscopically, and was therefore interpreted to be an adaptive effect, and non-adverse. Further mild effects were reduced body weight gain at top dose (8% lower for males and 5% lower in females), vacuolation of the urothelium in the urinary bladder and higher kidney and heart weights in females, that were not considered adverse. These latter findings were without microscopic or macroscopic correlate, generally low in magnitude and without any corroborative evidence of alteration of function, and hence considered to be not adverse. Thus, the NOAEL for general toxicity was at ≥ 120 mg/kg bw/d for males and females. In summary, different studies observe similar effects of CA on male rat reproductive organs and function below the dose for general toxicity, while effects in females only occur at the dose of general toxicity. Depending on treatment duration, male reproductive function is affected with a NOAEL of 25 mg to 30 mg in the studies with treatment for 83 – 90 days while the NOAEL is at 100 – 125 mg / kg bw/d in the studies conducted for 14 – 28 days (100 mg /kg bw/d for directional effects). The NOAEL for general toxicity is occurring at the same or at one higher dose group, and is mostly based on changes in organ weights, especially on liver weights. 14 -day Study (Rabbits): The potential toxicity of CA was studied by oral gavage dosing of 0, 30, 100 or 300 mg/kg bw/d for 14 consecutive days to groups of five male New Zealand White rabbits. Potential effects on the male reproductive organs, including sperm parameters were specifically assessed. Body weights, body weight gains and food consumption values were comparable among the groups and were unaffected by dosages of CA as high as 300 mg/kg/d. CA did not affect the weights of the reproductive (testes, epididymides, seminal vesicles [with and without fluid] or prostate) or non-reproductive (liver or kidneys) tissues at any dosage level. There were no microscopic findings in the testes or epididymides at the 300 mg/kg/d dose observed. In addition, there were no changes in sperm motility (number and percentage of motile sperm or non-motile sperm from ejaculated semen samples), sperm concentration (total and cauda epididymal sperm count and density) or sperm morphology at any dosage level. Thus, a NOAEL of ≥ 300 mg/kg bw/d for both general toxicity and for effects on male reproductive organs was determined for CA when administered orally to male rabbits for 14 days at dosages up to 300 mg/kg/d. Cyclamen aldehyde (CA; 3-(4-isopropylphenyl)-2-methylpropanal) has been widely used for the last 100 years as a muguet note in perfumery. The safe use of this material is well established through the understanding of exposure and based on quantitative risk assessment confirmed by the RIFM Expert Panel, which is supported by a wide range of toxicology studies conducted over the last 20 years. Repeated dose studies in rats performed for hazard identification had indicated adverse effects on sperm maturation leading to impaired fertility. CA is structurally related to some other aryl substituted branched chain aromatic aldehydes, that have shown a propensity for spermatogenic effects in the rat. These aldehydes are metabolized by primary hepatocytes to para-substituted benzoic acid derivatives. An example of such an intermediary metabolite with reported male reprotoxicity in the rat is 4-tert-butyl-benzoic acid (p-tBBA). In rats, CA is efficiently transformed by oxidative degradation of the side-chain to 4-isopropyl-benzoic acid (iPBA)on the one hand and by hydroxylation (putative at the isopropyl group) on the other hand. The effect on spermatogenesis appears to be linked to iPBA, the main circulating metabolite. iPBA and its conjugates were detected as dominant circulating metabolites, reaching a concentration of 264mM in plasma 24 h after the last dosing at the toxic dose of 300 mg/kg bw/d of CA. However, metabolism studies in rat, rabbit and human primary cultures of suspended hepatocytes, indicated species differences with iPBA readily formed by rat hepatocytes but below detection limit in cells from rabbits and humans. In plated rat hepatocytes, iPBA is detected as Coenzyme A-conjugate and this conjugate (iPBA-CoA) accumulates to rather stable levels over 22 h. It has been shown, that in vitro accumulation of CoA-conjugates is a metabolic hallmark strongly correlated to male rat reproductive toxicity for a number of structurally related compounds. iPBA-CoA is also formed in vivo both in the liver and in the testes of rats dosed with CA. iPBA-CoA does not accumulate in plated rabbit and human hepatocytes where it is rapidly cleared within 22 h. In a rabbit in vivo study, no effects of CA on spermatogenesis were observed. Thus, a species specific metabolic fate linked to CA toxicity in male rats can be postulated based on analytical data invitro and in vivo in the liver, and in male reproductive tissue in vivo. There is strong evidence that this species specific metabolic fate in the rat is not relevant to the rabbit, which is a non-responder species. Finally, lack of accumulation of iPBA-CoA in human hepatocytes indicates that like the rabbit, humans are unlikely to be vulnerable to iPBA hepatic and testicular toxicity. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36e771ea-3ed3-4063-94c1-145bb05d4176/documents/IUC5-aa6a219c-6173-44bb-be09-45840e2e9849_9b22fed4-14b9-45b4-85c8-bf1496f12c90.html,,,,,, 3-p-cumenyl-2-methylpropionaldehyde,103-95-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36e771ea-3ed3-4063-94c1-145bb05d4176/documents/IUC5-aa6a219c-6173-44bb-be09-45840e2e9849_9b22fed4-14b9-45b4-85c8-bf1496f12c90.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat 3-p-cumenyl-2-methylpropionaldehyde,103-95-7, Rats: Oral: LD₅₀ 3810 mg/kg bw/d and estimated LD50 can be considered to be > 5000 mg/kg/d (previous-guideline study). Oral: LD₅₀ ca. 5000 mg/kg bw (previous-guideline study). Oral :LD₅₀ >2000 mg/kg bw (previous-guideline study). Dermal LD50>5000 mg/kg bw (previous-guideline study). Rabbits: Dermal LD50>5000 mg/kg bw (previous-guideline study). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36e771ea-3ed3-4063-94c1-145bb05d4176/documents/IUC5-b25cf00f-4dc9-4b9e-bbab-577dceb1b217_9b22fed4-14b9-45b4-85c8-bf1496f12c90.html,,,,,, 3-p-cumenyl-2-methylpropionaldehyde,103-95-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36e771ea-3ed3-4063-94c1-145bb05d4176/documents/IUC5-b25cf00f-4dc9-4b9e-bbab-577dceb1b217_9b22fed4-14b9-45b4-85c8-bf1496f12c90.html,,oral,LD50,"3,180 mg/kg bw",no adverse effect observed, 3-p-cumenyl-2-methylpropionaldehyde,103-95-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36e771ea-3ed3-4063-94c1-145bb05d4176/documents/IUC5-b25cf00f-4dc9-4b9e-bbab-577dceb1b217_9b22fed4-14b9-45b4-85c8-bf1496f12c90.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Cycloheptapentylose,7585-39-9," In a 52 week chronic feeding study with rats minimal effects on liver and minimal pigment deposition in the epthelium of cortical tubules were obseerved at converted doses of 1313 mg/kg b.w./day and 1743 mg/kg b.w. /day for male and females, respectiveley. At higher concetration these effects increased in incidence but not in severity. In a thirteen week subchronic feeding study no such effects were observed at an equivalent dose of about 9000 mg/kg b.w. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/499d8a7b-9404-4993-9ea4-20025ac58119/documents/IUC5-624ac920-9dfa-447e-8981-ebc104003e20_aebf85cc-8772-4bf3-8702-50d479c837e0.html,,,,,, Cycloheptapentylose,7585-39-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/499d8a7b-9404-4993-9ea4-20025ac58119/documents/IUC5-624ac920-9dfa-447e-8981-ebc104003e20_aebf85cc-8772-4bf3-8702-50d479c837e0.html,Chronic toxicity – systemic effects,oral,LOAEL,"1,313 mg/kg bw/day",,rat Cycloheptapentylose,7585-39-9,".Beta.-Cyclodextrin is relatively harmless in case of oral, dermal and inhalative administration. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/499d8a7b-9404-4993-9ea4-20025ac58119/documents/IUC5-96579bbf-dbef-4783-b598-9837479a7cca_aebf85cc-8772-4bf3-8702-50d479c837e0.html,,,,,, Cycloheptapentylose,7585-39-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/499d8a7b-9404-4993-9ea4-20025ac58119/documents/IUC5-96579bbf-dbef-4783-b598-9837479a7cca_aebf85cc-8772-4bf3-8702-50d479c837e0.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Cycloheptapentylose,7585-39-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/499d8a7b-9404-4993-9ea4-20025ac58119/documents/IUC5-96579bbf-dbef-4783-b598-9837479a7cca_aebf85cc-8772-4bf3-8702-50d479c837e0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Cycloheptapentylose,7585-39-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/499d8a7b-9404-4993-9ea4-20025ac58119/documents/IUC5-96579bbf-dbef-4783-b598-9837479a7cca_aebf85cc-8772-4bf3-8702-50d479c837e0.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "1,1-dimethoxycyclododecane",950-33-4,"Oral (acute oral toxicity study), mouse: LD50: 30.3 g/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23e7f231-f97e-4241-81f4-6bec51f21238/documents/IUC5-a9bc2e7f-031b-4604-a7e2-1b752ec1d886_30a35887-7371-424f-ae17-8d8509e0f0c6.html,,,,,, Cyclohexane,110-82-7," The NOAEC for subchronic toxicity in mice is 2000 ppm (6,880 mg/m3) (based on haematological changes at 7000 ppm (24,080 mg/m3). In both rats and mice, the NOEC for acute, transient effects was 500 ppm (1,720 mg/m3). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc85222a-89cf-4e41-8d3c-99249c1de818/documents/IUC5-d4e72252-fe8b-4714-ae19-4684371823b4_2f92dca6-72f3-4e13-abb5-000fad3b5b95.html,,,,,, Cyclohexane,110-82-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc85222a-89cf-4e41-8d3c-99249c1de818/documents/IUC5-d4e72252-fe8b-4714-ae19-4684371823b4_2f92dca6-72f3-4e13-abb5-000fad3b5b95.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"6,880 mg/m3",,mouse Cyclohexane,110-82-7," Cyclohexane is of low acute toxicity by the oral (LD50 >5,000 mg/kg), inhalation (4 h LC50 >32,880 mg/m3) or dermal (LD50 >2,000 mg/kg) routes. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc85222a-89cf-4e41-8d3c-99249c1de818/documents/IUC5-be0ff3fa-be01-484a-92be-07e9467fb6ea_2f92dca6-72f3-4e13-abb5-000fad3b5b95.html,,,,,, Cyclohexane,110-82-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc85222a-89cf-4e41-8d3c-99249c1de818/documents/IUC5-be0ff3fa-be01-484a-92be-07e9467fb6ea_2f92dca6-72f3-4e13-abb5-000fad3b5b95.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Cyclohexane,110-82-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc85222a-89cf-4e41-8d3c-99249c1de818/documents/IUC5-be0ff3fa-be01-484a-92be-07e9467fb6ea_2f92dca6-72f3-4e13-abb5-000fad3b5b95.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Cyclohexane,110-82-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc85222a-89cf-4e41-8d3c-99249c1de818/documents/IUC5-be0ff3fa-be01-484a-92be-07e9467fb6ea_2f92dca6-72f3-4e13-abb5-000fad3b5b95.html,,inhalation,LC50,"> 32,880 mg/m3",no adverse effect observed, Cyclohexanecarboxylic acid,98-89-5,"According to Directive 67/548/EEC and to Regulation (EC) n. 1272/2008, the substance should not be classified for oral acute toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/626fb1c4-6f63-4c1a-92dd-c0f3f6904d62/documents/IUC5-00fe982a-3298-49b3-b811-06de12c1360f_1055ea1a-9f5c-4707-b707-3279f6711e68.html,,,,,, Cyclohexanecarboxylic acid,98-89-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/626fb1c4-6f63-4c1a-92dd-c0f3f6904d62/documents/IUC5-00fe982a-3298-49b3-b811-06de12c1360f_1055ea1a-9f5c-4707-b707-3279f6711e68.html,,oral,LD50,"3,265 mg/kg bw",no adverse effect observed, Cyclohexanol,108-93-0," Oral route NOAEL = 143 mg/kg bw/day, 3 months, read-across from cyclohexanone, OECD 408, BASF (1994) NOAEL = 462 mg/kg bw/day, 2 years, read-across from cyclohexanone, OECD 453, Lijinsky (1986) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/596fd274-f418-458a-b557-d0722bedad3a/documents/3b664896-daba-46a2-9bbd-28cbae55bb17_a16c4830-596b-4cf0-ae82-d8348ed3c595.html,,,,,, Cyclohexanol,108-93-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/596fd274-f418-458a-b557-d0722bedad3a/documents/3b664896-daba-46a2-9bbd-28cbae55bb17_a16c4830-596b-4cf0-ae82-d8348ed3c595.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,143 mg/kg bw/day,,rat Cyclohexanol,108-93-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/596fd274-f418-458a-b557-d0722bedad3a/documents/3b664896-daba-46a2-9bbd-28cbae55bb17_a16c4830-596b-4cf0-ae82-d8348ed3c595.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"2,007.2 mg/m3",,rat Cyclohexanol,108-93-0," In five available oral acute toxicity studies in the rat the LD50 values ranged from 1400 to 2600 mg/kg bw. A reliable acute inhalation toxicity study in the rat resulted in a 4-hour LC50 value of >3.6 mg/L. Three weight-of-evidence acute dermal toxicity studies in the rabbit are available; two were producing LD50 values in the range from 1000 to 2000 mg/kg bw, one resulted in a LD50 value in the range from 501 to 794 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/596fd274-f418-458a-b557-d0722bedad3a/documents/ca89d426-c050-4cdd-837c-bb2892a1413e_a16c4830-596b-4cf0-ae82-d8348ed3c595.html,,,,,, Cyclohexanol,108-93-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/596fd274-f418-458a-b557-d0722bedad3a/documents/ca89d426-c050-4cdd-837c-bb2892a1413e_a16c4830-596b-4cf0-ae82-d8348ed3c595.html,,oral,LD50,"1,400 mg/kg bw",adverse effect observed, Cyclohexanol,108-93-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/596fd274-f418-458a-b557-d0722bedad3a/documents/ca89d426-c050-4cdd-837c-bb2892a1413e_a16c4830-596b-4cf0-ae82-d8348ed3c595.html,,dermal,discriminating dose,"1,250 mg/kg bw",adverse effect observed, Cyclohexanol,108-93-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/596fd274-f418-458a-b557-d0722bedad3a/documents/ca89d426-c050-4cdd-837c-bb2892a1413e_a16c4830-596b-4cf0-ae82-d8348ed3c595.html,,inhalation,discriminating conc.,"3,600 mg/m3",no adverse effect observed, Cyclohexanone,108-94-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16b5c4d3-777e-41bc-a16e-5dbabe2bf162/documents/IUC5-febb600e-2ba3-4dca-8cf9-bc0ce0bf690f_5aeafd6a-bb36-4fd8-a194-fe43235c4169.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,143 mg/kg bw/day,,rat Cyclohexanone,108-94-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16b5c4d3-777e-41bc-a16e-5dbabe2bf162/documents/IUC5-febb600e-2ba3-4dca-8cf9-bc0ce0bf690f_5aeafd6a-bb36-4fd8-a194-fe43235c4169.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,408 mg/m3,,rat Cyclohexanone,108-94-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16b5c4d3-777e-41bc-a16e-5dbabe2bf162/documents/IUC5-fd34c808-3417-42fb-9290-5abb0a808069_5aeafd6a-bb36-4fd8-a194-fe43235c4169.html,,oral,LD50,"1,890 mg/kg bw",adverse effect observed, Cyclohexanone,108-94-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16b5c4d3-777e-41bc-a16e-5dbabe2bf162/documents/IUC5-fd34c808-3417-42fb-9290-5abb0a808069_5aeafd6a-bb36-4fd8-a194-fe43235c4169.html,,inhalation,discriminating conc.,"6,200 mg/m3",adverse effect observed, Dodecamethylcyclohexasiloxane,540-97-6,"The key 90-day repeated dose inhalation toxicity study in rats with dodecamethylcyclohexasiloxane (D6) was conducted according to OECD Test Guideline 413 and in compliance with GLP (Dow Corning Corporation, 2013). The systemic NOAEC was concluded to be greater than 30 ppm (546 mg/m³) based on the absence of adverse effects in either sex up to the highest dose tested. The study report concluded that the local NOAEC was 1 ppm (18.2 mg/m³), the lowest concentration tested, based on hyperplasia and inflammation in the nasal tissues at 10 (182 mg/m3) and 30 ppm (546 mg/m3), indicative of a mucosal irritation and therefore local effects. However, an independent expert review of the study (see attachment for full report) concluded that the morphological findings were consistent with an adaptive response to deposited test material in the aerosol phase and not an adverse effect of the test material itself. Additionally, the findings observed in the nasal passages of obligate nasal breathing rats, which have thicker mucous layers lining the airways, are of questionable relevance to humans. It was therefore concluded that the NOAEC is greater than the highest concentration tested (546 mg/m3).    The key repeated dose oral toxicity study with dodecamethylcyclohexasiloxane (D6) (Dow Corning Corporation, 2005) was a 4-week rat combined repeated dose toxicity study with the reproductive/developmental toxicity study screening test, conducted according to OECD Test Guideline 422 and in compliance with GLP. A NOAEL of at least 1000 mg/kg bw/day, the highest dose tested, was reported in the study. The observed liver effects (increased absolute and/or relative liver weight in all treated groups and periportal lipidosis at all doses in females) were described as “of minimal toxicologic significance” and the thyroid effects (follicular cell hypertrophy, incidence possibly treatment-related in both sexes) were referred to as secondary and adaptive to the liver changes. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29fc1d9e-f066-4ddb-b6c2-2caf5195cfe6/documents/0698fe99-1b43-40a0-8f41-19d738f164fb_e70db12e-9c91-44a3-b2b0-63a91fd5c912.html,,,,,, Dodecamethylcyclohexasiloxane,540-97-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29fc1d9e-f066-4ddb-b6c2-2caf5195cfe6/documents/0698fe99-1b43-40a0-8f41-19d738f164fb_e70db12e-9c91-44a3-b2b0-63a91fd5c912.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dodecamethylcyclohexasiloxane,540-97-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29fc1d9e-f066-4ddb-b6c2-2caf5195cfe6/documents/0698fe99-1b43-40a0-8f41-19d738f164fb_e70db12e-9c91-44a3-b2b0-63a91fd5c912.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,546 mg/m3,,rat Dodecamethylcyclohexasiloxane,540-97-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29fc1d9e-f066-4ddb-b6c2-2caf5195cfe6/documents/0698fe99-1b43-40a0-8f41-19d738f164fb_e70db12e-9c91-44a3-b2b0-63a91fd5c912.html,Repeated dose toxicity – local effects,inhalation,NOAEC,>= 546 mg/m3,no adverse effect observed,rat Dodecamethylcyclohexasiloxane,540-97-6," In the key acute oral toxicity study with dodecamethylcyclohexasiloxane (D6) (NOTOX, 1999a), conducted according to OECD Test Guideline 423 and in compliance with GLP, an LD50 value of greater than 2000 mg/kg bw was concluded. In the key acute dermal toxicity study with dodecamethylcyclohexasiloxane (D6) (NOTOX, 1999b), conducted according to OECD Test Guideline 402 and in compliance with GLP, an LD50 value of greater than 2000 mg/kg bw was concluded. No inhalation studies are available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29fc1d9e-f066-4ddb-b6c2-2caf5195cfe6/documents/6307b411-cf58-4667-9677-df65ec8a1851_e70db12e-9c91-44a3-b2b0-63a91fd5c912.html,,,,,, Dodecamethylcyclohexasiloxane,540-97-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29fc1d9e-f066-4ddb-b6c2-2caf5195cfe6/documents/6307b411-cf58-4667-9677-df65ec8a1851_e70db12e-9c91-44a3-b2b0-63a91fd5c912.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dodecamethylcyclohexasiloxane,540-97-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29fc1d9e-f066-4ddb-b6c2-2caf5195cfe6/documents/6307b411-cf58-4667-9677-df65ec8a1851_e70db12e-9c91-44a3-b2b0-63a91fd5c912.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-(cyclohex-1-en-1-yl)-3-methylbutan-1-ol,1359994-45-8, Oral LD50 is 1000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40048a23-68b6-49ba-b2ae-bed1dd63d0f7/documents/d310475c-2c9c-4518-a6c6-cf0d9ee0e446_05203adb-34c7-4256-a8f2-634cf43155be.html,,,,,, 4-(cyclohex-1-en-1-yl)-3-methylbutan-1-ol,1359994-45-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40048a23-68b6-49ba-b2ae-bed1dd63d0f7/documents/d310475c-2c9c-4518-a6c6-cf0d9ee0e446_05203adb-34c7-4256-a8f2-634cf43155be.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, [2-(cyclohexyloxy)ethyl]benzene,80858-47-5,Acute oral toxicity: OECD TG 401: > 5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf9f5f7b-734f-4575-b1f1-03bc55f065f2/documents/IUC5-48bb7e7f-d2f4-451d-8394-b4ed2ac6f342_0c2b2725-c2f9-4da2-b017-115b12a85ea8.html,,,,,, 4-cyclohexyl-4-methylpentan-2-one,4927-39-3,The substance is not acute oral toxic. The LD50 value is greater than 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6b3a8fd-a845-4577-971a-3e69ac80a880/documents/IUC5-3b137be7-fcb8-44d5-ac51-3d6389021f38_1a0ec696-018e-403a-ac45-f43233f42252.html,,,,,, 4-cyclohexyl-4-methylpentan-2-one,4927-39-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6b3a8fd-a845-4577-971a-3e69ac80a880/documents/IUC5-3b137be7-fcb8-44d5-ac51-3d6389021f38_1a0ec696-018e-403a-ac45-f43233f42252.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Cyclohexylamine,108-91-8,"Based on the chronic studies discussed above and the available comprehensive reviews of the available subacute and subchronic data (Bopp et al., 1986, NL Health Council 2010, MAK 2006) it can be concluded, that the NOAEL for repeated dose toxicity after oral ingestion is 15 mg/kg bw/day in rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4705eb9-511c-41f8-985f-781fe845a9d5/documents/IUC5-a92d1e39-a1bf-48ec-ad71-0982026281a9_19a00673-01f2-44ba-a15f-5975404239a4.html,,,,,, Cyclohexylamine,108-91-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4705eb9-511c-41f8-985f-781fe845a9d5/documents/IUC5-a92d1e39-a1bf-48ec-ad71-0982026281a9_19a00673-01f2-44ba-a15f-5975404239a4.html,Chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat Cyclohexylamine,108-91-8,In general LD50 values in oral acute studies are between 150 mg/kg and 1660 mg/kg. Only limited data are available concerning acute dermal toxicity. The lowest LD50 reported in the literature is 275 mg/kg. Cyclohexylamine is of low acute inhalation toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4705eb9-511c-41f8-985f-781fe845a9d5/documents/IUC5-55545ea1-4781-443e-9acd-f0037fc00922_19a00673-01f2-44ba-a15f-5975404239a4.html,,,,,, 1-cyclohexylethanol,1193-81-3," Acute oral toxicity (somewhat similar to OECD TG 401): LD50 = 2100 mg/kg bw. Acute dermal toxicity (somewhat equivalent to OECD TG 402): No correct LD50 could be derived, the LD50 is very likely between 794 mg/kg bw and 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bf6579e-6025-4b31-b643-293159aeb2e3/documents/97a0acf4-789f-4c0a-bacd-6f1162640e61_07889eaa-f3ae-427e-9b5a-c097e936f905.html,,,,,, α-methylcyclohexylmethyl acetate,13487-27-9,Acute oral toxicity: similar to OECD TG 401: LD50 8200 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11e4cbfb-98f8-4de3-bf72-d4e386f0af8e/documents/IUC5-0a3ac590-fd7d-46ef-8b86-bd303409df1c_154d0b4e-2416-4a4e-8f9d-f76b939220a9.html,,,,,, 1-cyclohexylethyl butyrate,63449-88-7," Some information on repeated dose and reproductive toxicity is available for this registered substance, which is not included because it does not affect the classification and labelling ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09b95835-d670-430e-8014-b3e276e08f1f/documents/e5f0ab6c-c3e0-4589-a4f7-10f285bc2f51_47c83e79-6e0d-4745-a685-b84f24716cb7.html,,,,,, 1-cyclohexylethyl butyrate,63449-88-7,Acute oral toxicity: similar to OECD TG 401: LD50 8300 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09b95835-d670-430e-8014-b3e276e08f1f/documents/IUC5-da512a76-903a-4b84-a5cb-ae77d234dd26_47c83e79-6e0d-4745-a685-b84f24716cb7.html,,,,,, "3-(cyclohexyloxy)propane-1,2-diol",10305-41-6,"Oral (OECD TG 401), rat: LD50 > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad344421-c9c3-45bc-bfc5-81e97d5a9e1d/documents/IUC5-967eecb0-c3c9-4501-b5a1-4d834f414091_81891684-11c1-4375-aa49-e09106374aba.html,,,,,, Octamethylcyclotetrasiloxane,556-67-2," In the key repeated dose inhalation study, exposure to D4 for up to 24 months (Batelle, 2004) resulted in a NOAEC for general toxicity of 150 ppm, based on chronic nephropathy. The NOAEC for local respiratory effects was also 150 ppm based on findings in the nasal cavity. In a three-week dermal exposure study (Bayer AG, 1988) in rabbits conducted using a protocol similar to OECD 410 and GLP, there were no adverse effects and therefore the dermal NOAEL was ≥ 1 ml/kg bw/day (equivalent to ≥960 mg/kg bw/day). There are no reliable data that define a NOAEL for the oral route. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65500976-9c68-49cf-b250-12fda79d206e/documents/c3a0b9dd-3746-4623-b55e-a5bc1b3d1479_9e985ff4-3852-4375-a6f6-736352c90121.html,,,,,, Octamethylcyclotetrasiloxane,556-67-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65500976-9c68-49cf-b250-12fda79d206e/documents/c3a0b9dd-3746-4623-b55e-a5bc1b3d1479_9e985ff4-3852-4375-a6f6-736352c90121.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,960 mg/kg bw/day,,rabbit Octamethylcyclotetrasiloxane,556-67-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65500976-9c68-49cf-b250-12fda79d206e/documents/c3a0b9dd-3746-4623-b55e-a5bc1b3d1479_9e985ff4-3852-4375-a6f6-736352c90121.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,820 mg/m3",,rat Octamethylcyclotetrasiloxane,556-67-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65500976-9c68-49cf-b250-12fda79d206e/documents/c3a0b9dd-3746-4623-b55e-a5bc1b3d1479_9e985ff4-3852-4375-a6f6-736352c90121.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,820 mg/m3",adverse effect observed,rat Octamethylcyclotetrasiloxane,556-67-2," In the key (a single dose only) acute oral study (Bayer AG, 1979) in male rats, the LD50 was greater than 4800 mg/kg bw. There were no deaths or clinical signs of toxicity at this dose.   In the key acute inhalation study (RCC, 1994), rats were exposed to a nose only single 4-hour exposure of a mixture of vapour and liquid D4. All animals showed initial body weight loss and slightly reduced food intakes. Hunched posture, stiff gait, ruffled fur were noted in all groups with restlessness and/or excitement during exposure among those animals that died. At necropsy, decedents had a red discoloration of the lungs which was likely due to the aerosol exposure. The LC50 was calculated to be 36 mg/L air/4h, corresponding to an atmosphere of 2975 ppm.   The LD50 in the key dermal study (Bayer AG, 1985) in rats was >2.5 ml/kg bw (>2375 mg/kg bw based on density of 0.95 g/cm3). No deaths occurred and no clinical signs were observed following a single application of undiluted D4.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65500976-9c68-49cf-b250-12fda79d206e/documents/d8fef9a8-d3e9-487b-add9-fe6658f0c5f8_9e985ff4-3852-4375-a6f6-736352c90121.html,,,,,, Octamethylcyclotetrasiloxane,556-67-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65500976-9c68-49cf-b250-12fda79d206e/documents/d8fef9a8-d3e9-487b-add9-fe6658f0c5f8_9e985ff4-3852-4375-a6f6-736352c90121.html,,oral,LD50,"4,800 mg/kg bw",no adverse effect observed, Octamethylcyclotetrasiloxane,556-67-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65500976-9c68-49cf-b250-12fda79d206e/documents/d8fef9a8-d3e9-487b-add9-fe6658f0c5f8_9e985ff4-3852-4375-a6f6-736352c90121.html,,dermal,LD50,"2,375 mg/kg bw",no adverse effect observed, Octamethylcyclotetrasiloxane,556-67-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65500976-9c68-49cf-b250-12fda79d206e/documents/d8fef9a8-d3e9-487b-add9-fe6658f0c5f8_9e985ff4-3852-4375-a6f6-736352c90121.html,,inhalation,LC50,"36,000 mg/m3",adverse effect observed, Decamethylcyclopentasiloxane,541-02-6," A well reported 90-day oral study (Bayer AG, 1991), conducted in the main according to the current guideline and in accordance with GLP is reported. For the purposes of human hazard assessment, the NOAEL is considered to be greater than or equal to the highest dose tested, 1000 mg/kg/day.   The key repeated dose inhalation toxicity study (RCC Ltd., 2005) is a two-year combined chronic toxicity and carcinogenicity study in rats conducted to an EPA guideline, to OECD guideline 453 and to GLP. In these studies the highest vapour concentration that could be reliably and effectively generated without appreciable aerosol or condensation was observed to be 160 ppm. The NOAEC for general toxicity in this study was ≥160 ppm (2420 mg/m3; the highest dose tested). Local effects on the nasal cavity and adaptive increases in liver weights (with no microscopic findings) were observed. The NOAEC for carcinogenic effects was ≥160ppm (2420mg/m3).   In the key dermal study, administration of undiluted D5 under occlusive conditions over a 28-day period at doses up to and including 1600 mg/kg bw/day resulted in no adverse effects on survival, body weight, food consumption, clinical observations, clinical pathology, haematology, ophthalmoscopy, organ weights, or gross or microscopic pathology, and no dermal irritation (Dow Corning Corporation 1990d). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0ed2745-63b8-4fa6-aca6-59cf122f46fb/documents/85dcc476-7f16-4ccb-98e4-326344c6ac00_5f4e6d61-b6e0-4028-ad4a-2255aa454dfb.html,,,,,, Decamethylcyclopentasiloxane,541-02-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0ed2745-63b8-4fa6-aca6-59cf122f46fb/documents/85dcc476-7f16-4ccb-98e4-326344c6ac00_5f4e6d61-b6e0-4028-ad4a-2255aa454dfb.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,600 mg/kg bw/day",,rat Decamethylcyclopentasiloxane,541-02-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0ed2745-63b8-4fa6-aca6-59cf122f46fb/documents/85dcc476-7f16-4ccb-98e4-326344c6ac00_5f4e6d61-b6e0-4028-ad4a-2255aa454dfb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Decamethylcyclopentasiloxane,541-02-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0ed2745-63b8-4fa6-aca6-59cf122f46fb/documents/85dcc476-7f16-4ccb-98e4-326344c6ac00_5f4e6d61-b6e0-4028-ad4a-2255aa454dfb.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"2,420 mg/m3",,rat Decamethylcyclopentasiloxane,541-02-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0ed2745-63b8-4fa6-aca6-59cf122f46fb/documents/85dcc476-7f16-4ccb-98e4-326344c6ac00_5f4e6d61-b6e0-4028-ad4a-2255aa454dfb.html,Repeated dose toxicity – local effects,inhalation,NOAEC,600 mg/m3,adverse effect observed,rat Decamethylcyclopentasiloxane,541-02-6," In the key acute oral toxicity study (Toxikon Corporation, 1990a), which was comparable to the now deleted OECD 401, and to GLP, the LD50 value for male and female rats was >5000 mg/kg bw.   In the key acute inhalation toxicity study (RCC, 1994), which was comparable to OECD 403, and to GLP, the LC50 value was 8670 mg/m3.   In the key acute dermal toxicity limit test (WIL Research Laboratories, 1977), which was pre-GLP, but comparable to OECD 402, the LD50 value was >2000 mg/kg bw.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0ed2745-63b8-4fa6-aca6-59cf122f46fb/documents/e10c30fc-95a2-415c-8f89-6e8e9d0195eb_5f4e6d61-b6e0-4028-ad4a-2255aa454dfb.html,,,,,, Decamethylcyclopentasiloxane,541-02-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0ed2745-63b8-4fa6-aca6-59cf122f46fb/documents/e10c30fc-95a2-415c-8f89-6e8e9d0195eb_5f4e6d61-b6e0-4028-ad4a-2255aa454dfb.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Decamethylcyclopentasiloxane,541-02-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0ed2745-63b8-4fa6-aca6-59cf122f46fb/documents/e10c30fc-95a2-415c-8f89-6e8e9d0195eb_5f4e6d61-b6e0-4028-ad4a-2255aa454dfb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Decamethylcyclopentasiloxane,541-02-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0ed2745-63b8-4fa6-aca6-59cf122f46fb/documents/e10c30fc-95a2-415c-8f89-6e8e9d0195eb_5f4e6d61-b6e0-4028-ad4a-2255aa454dfb.html,,inhalation,LC50,"8,670 mg/m3",adverse effect observed, Methoxycarbonyloxycyclooct-4-ene,87731-18-8,The NOAEL for repeated dose toxicity is set to 500 mg/kg bw based on acute and all repeated dose toxicity information.  Several studies are used to derive a NOAEL for repeated dose toxicity. Based on the acute oral toxicity study (LC50 2400 mg/kg bw) the highest dose selected in the 28-day gavage OECD TG 407 was 500 mg/kg bw at which no adverse effects were seen. Dietary dosing was selected for the next studies (DRF for OECD TG 421 and OECD TG 421) because peak exposure are prevented as well as potential acidic/irritation due to ester (carboxylate) cleavage. The highest dose in the 14-day DRF for the Reproscreen study was 1000 mg/kg bw (15000 ppm) nominal. At this dose food consumption and body weight were reduced (probably due to palatability). Also high increased relative liver weight especially in males was seen (+48%). Therefore the highest dose tested in the Reproscreen study is  500 mg/kg bw (7500 ppm) in which no adverse repeated dose toxicity was seen. Therefore the NOAEL is set to 500 mg/kg bw based on acute oral toxicity at 2000 mg/kg bw (2 females died) and based on highly increased liver weight at 1000 mg/kg bw (+48%) in the DRF for the OECD TG 421. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1062ca9-dc76-465c-b61f-20fd6516f83c/documents/IUC5-17bd96a0-dd1d-481f-bb93-1d4c6ea8e634_d66bcb3f-bbc7-4d9b-8a28-c8521e5a4bb4.html,,,,,, Methoxycarbonyloxycyclooct-4-ene,87731-18-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1062ca9-dc76-465c-b61f-20fd6516f83c/documents/IUC5-17bd96a0-dd1d-481f-bb93-1d4c6ea8e634_d66bcb3f-bbc7-4d9b-8a28-c8521e5a4bb4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Methoxycarbonyloxycyclooct-4-ene,87731-18-8,"Acute oral toxicity: LD50 is >2000 mg/kg bw in an OECD TG 401 Acute toxicity inhalation: LC50 is 6240 mg/m3 using route to route extrapolation and vapour exposure Acute dermal toxicity: LD50 is >2000 mg/kg bw in an OECD TG 402. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The one acute oral toxicity study available is of sufficient quality for the present dossier. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The acute inhalation toxicity is derived using route to route extrapolation from the acute toxicity results, using 100% absorption. This assessment is considered to be sufficiently adequate for covering this endpoint. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The one acute dermal toxicity study available is of sufficient quality for the present dossier. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1062ca9-dc76-465c-b61f-20fd6516f83c/documents/IUC5-9891c08b-83b9-4cc0-8bb9-1e139a1ad748_d66bcb3f-bbc7-4d9b-8a28-c8521e5a4bb4.html,,,,,, Cyclopentadecanone,502-72-7," In the available OECD guideline 422 study increased liver weight in males (18% above the controls) and hepatocellular hypertrophy and follicular cell hypertrophy of the thyroid gland in both sexes were seen in parental animals at the lowest dose level of 100 mg/kg bw/day. Athough these changes were considered to be non-adverse by the study director, for risk assessment purposes the dose level of 100 mg/kg bw/day is considered to be a LOAEL for general toxicity. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/887842c4-40b0-47c6-9ed0-a1d658028af2/documents/740ea5a7-eadb-46b1-9ce4-192d6008cc32_37968b73-d33b-4055-973c-9965dc04a3ce.html,,,,,, Cyclopentadecanone,502-72-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/887842c4-40b0-47c6-9ed0-a1d658028af2/documents/740ea5a7-eadb-46b1-9ce4-192d6008cc32_37968b73-d33b-4055-973c-9965dc04a3ce.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat Cyclopentadecanone,502-72-7, Cyclopentadecanone is not acutely toxic by oral and dermal route. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/887842c4-40b0-47c6-9ed0-a1d658028af2/documents/ae10a380-75fa-4328-926a-1ce5a2036979_37968b73-d33b-4055-973c-9965dc04a3ce.html,,,,,, Cyclopentadecanone,502-72-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/887842c4-40b0-47c6-9ed0-a1d658028af2/documents/ae10a380-75fa-4328-926a-1ce5a2036979_37968b73-d33b-4055-973c-9965dc04a3ce.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Cyclopentadecanone,502-72-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/887842c4-40b0-47c6-9ed0-a1d658028af2/documents/ae10a380-75fa-4328-926a-1ce5a2036979_37968b73-d33b-4055-973c-9965dc04a3ce.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Cyclopentanone,120-92-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fceb94dd-e09c-4d93-ab68-6f9deaa9e6e3/documents/f9270f9b-36f2-4d80-904d-fe403cb808bf_09695293-9d3a-486b-a393-1e8f5c20c860.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,723 mg/kg bw/day,,rat Cyclopentanone,120-92-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fceb94dd-e09c-4d93-ab68-6f9deaa9e6e3/documents/f9270f9b-36f2-4d80-904d-fe403cb808bf_09695293-9d3a-486b-a393-1e8f5c20c860.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"3,040 mg/m3",,rabbit Cyclopentanone,120-92-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fceb94dd-e09c-4d93-ab68-6f9deaa9e6e3/documents/f9270f9b-36f2-4d80-904d-fe403cb808bf_09695293-9d3a-486b-a393-1e8f5c20c860.html,Repeated dose toxicity – local effects,inhalation,NOAEC,750 mg/m3,adverse effect observed,rabbit Cyclopentanone,120-92-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fceb94dd-e09c-4d93-ab68-6f9deaa9e6e3/documents/e99b2772-bd7b-49a7-83bf-cc28e7a827b2_09695293-9d3a-486b-a393-1e8f5c20c860.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Cyclopentanone,120-92-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fceb94dd-e09c-4d93-ab68-6f9deaa9e6e3/documents/e99b2772-bd7b-49a7-83bf-cc28e7a827b2_09695293-9d3a-486b-a393-1e8f5c20c860.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Cyclopentanone,120-92-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fceb94dd-e09c-4d93-ab68-6f9deaa9e6e3/documents/e99b2772-bd7b-49a7-83bf-cc28e7a827b2_09695293-9d3a-486b-a393-1e8f5c20c860.html,,inhalation,LC50,"> 19,500 mg/m3",no adverse effect observed, "Cymbopogon citratus, ext.",89998-14-1,Acute oral toxicity: LD50>5000 mg/kg bw based on read across from Cymbopogon flexuosus (similar to OECD 401) Acute dermal toxicity: LD50>2000 mg/kg bw based on read across from Cymbopogon flexuosus (similar to OECD 402) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35d47dde-c628-4044-80bd-d2fcd1de6b1c/documents/9779a7d4-57c2-4bb9-af23-7a21745ce9c2_a6fa78de-403c-4346-a433-8b737fee1ae1.html,,,,,, "Cymbopogon citratus, ext.",89998-14-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35d47dde-c628-4044-80bd-d2fcd1de6b1c/documents/9779a7d4-57c2-4bb9-af23-7a21745ce9c2_a6fa78de-403c-4346-a433-8b737fee1ae1.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Cymbopogon citratus, ext.",89998-14-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35d47dde-c628-4044-80bd-d2fcd1de6b1c/documents/9779a7d4-57c2-4bb9-af23-7a21745ce9c2_a6fa78de-403c-4346-a433-8b737fee1ae1.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Cymbopogon winterianus, ext.",91771-61-8, Repeated dose toxicity (OECD TG 422): NOAEL >708 mg/kg bw/day for males and >771 mg/kg bw/day for females (highest dose tested) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fedb320a-0f12-4657-914d-800c38e91a2e/documents/19024287-1d60-4ee7-9cf4-ce752fb89fa2_be9f61ba-4d60-4324-a37d-d328dca1793f.html,,,,,, "Cymbopogon winterianus, ext.",91771-61-8, Acute oral toxicity: 300 >LD50< 2000 mg/kg bw (OECD 420) Acute dermal toxicity: LD50> 2000 mg/kg bw (OECD 402) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fedb320a-0f12-4657-914d-800c38e91a2e/documents/IUC5-1f6d5d45-ce80-4ea9-bb55-05ea41022e62_be9f61ba-4d60-4324-a37d-d328dca1793f.html,,,,,, "Cymbopogon winterianus, ext.",91771-61-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fedb320a-0f12-4657-914d-800c38e91a2e/documents/IUC5-1f6d5d45-ce80-4ea9-bb55-05ea41022e62_be9f61ba-4d60-4324-a37d-d328dca1793f.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "Cyperus scariosus, ext.",91771-62-9, LD50 (oral) > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/630e7d90-44b9-4fbe-bdee-3f0ffd503fc1/documents/a4262298-85b9-47dc-9254-0d420f583297_2e2ed7d2-3d64-4a63-a20c-abfe176b1461.html,,,,,, "Cyperus scariosus, ext.",91771-62-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/630e7d90-44b9-4fbe-bdee-3f0ffd503fc1/documents/a4262298-85b9-47dc-9254-0d420f583297_2e2ed7d2-3d64-4a63-a20c-abfe176b1461.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Mercaptamine hydrochloride,156-57-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68ec3edd-2ac9-447e-9073-f3cba4ed65c1/documents/87150a98-7c82-4ee0-bf76-a2c1d67c0b7a_0d57460d-342d-4842-8e18-74bfcd49f8b6.html,,oral,LD50,"1,352 mg/kg bw",adverse effect observed, L-cysteine,52-90-4," In an oral toxicity study for repeated exposure in rats, L-cysteine was administered with doses of 500, 1000, or 2000 mg / kg / day for 28 consecutive days (6 male rats / dose). The control group was treated with 0.5% of methylcellulose. The toxicological observations showed renal lesions and increase of basophilic tubules in all treated animals. At 1000 and 2000 mg / kg / day indicative symptoms of focal erosion were observed in the mucosa of the stomach. Finally, an increase in reticulocyte counting was found in rats treated with 2000 mg / kg / day of L-cysteine. In this study, the NOAEL was estimated <500 mg / kg / day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72f3cb6c-3cd2-4c41-940a-1cf10381a62b/documents/06c450de-fb66-4bb5-91e5-8958c3a19028_1360f777-f078-4f89-a059-f75e2727f99c.html,,,,,, L-cysteine,52-90-4, Acute toxicity (oral): LD50 rat = 1890 mg/kg Acute toxicity (dermal): LD50 rat > 2000 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72f3cb6c-3cd2-4c41-940a-1cf10381a62b/documents/57c7ce65-484d-4956-a7f1-d4f3f87d0369_1360f777-f078-4f89-a059-f75e2727f99c.html,,,,,, L-cysteine,52-90-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72f3cb6c-3cd2-4c41-940a-1cf10381a62b/documents/57c7ce65-484d-4956-a7f1-d4f3f87d0369_1360f777-f078-4f89-a059-f75e2727f99c.html,,oral,LD50,"1,890 mg/kg bw",adverse effect observed, Cysteine hydrochloride,52-89-1,"See section carcinogenicity (chronic study of Kitahori et al. 1997).The animals of the dosage groups showed dose-related toxic effects of the kidneys. No no-effect level was identified, but the clear decline of toxic effects beween the 2 dosages allows the estimation that a level of at least 13 mg/kg bw /day should be a no-effect level. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): One reliable study (Kitahori et al. 1997) with detailed documentation of results. Sufficient animal numbers. The study is valid with restrictions. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d5d87c33-4df6-44df-a2dd-3ce125cb098c/documents/603a7bf1-a92c-4ba7-a08f-d30faf03d1c4_e0064a81-3d7c-4cc6-9dd0-ae7a628feadc.html,,,,,, Cysteine hydrochloride,52-89-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d5d87c33-4df6-44df-a2dd-3ce125cb098c/documents/603a7bf1-a92c-4ba7-a08f-d30faf03d1c4_e0064a81-3d7c-4cc6-9dd0-ae7a628feadc.html,Chronic toxicity – systemic effects,oral,NOAEL,13 mg/kg bw/day,,rat Cysteine hydrochloride,52-89-1,"The oral LD50 of L-Cysteine hydrochloride monohydrate is higher than 2000 mg/kg bw. in the rat.The dermal LD50 of the test item L-Cysteine hydrochloride monohydrate is higher than 2000 mg/kg bw. by dermal route in the rat.In accordance with article 2(7)(b) and Annex V 6., REACH the hydrate free form of L-Cysteine hydrochloride is registered. L-Cysteine hydrochloride monohydrate (CAS 7048-04-6, hydrate part of the molecule = 10.25 %) is the manufactured and imported substance and was used for testing.It is generally accepted that water and especially water of crystallisation has no toxicologically relevant effects. Therefore, the effect levels of L-Cysteine hydrochloride monohydrate can be used to calculate the corresponding dosages of L-Cysteine hydrochloride (anhydrous (free of water of crystallisation)).Thus, the conclusion on hazard assessment and classification holds true for the anhydrous form as well. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5d87c33-4df6-44df-a2dd-3ce125cb098c/documents/8a781a20-5be6-4afe-ac06-446b3a7e75dd_e0064a81-3d7c-4cc6-9dd0-ae7a628feadc.html,,,,,, Cysteine hydrochloride,52-89-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5d87c33-4df6-44df-a2dd-3ce125cb098c/documents/8a781a20-5be6-4afe-ac06-446b3a7e75dd_e0064a81-3d7c-4cc6-9dd0-ae7a628feadc.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Cysteine hydrochloride,52-89-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5d87c33-4df6-44df-a2dd-3ce125cb098c/documents/8a781a20-5be6-4afe-ac06-446b3a7e75dd_e0064a81-3d7c-4cc6-9dd0-ae7a628feadc.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde",4501-58-0,"The acute oral toxicity for (R)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde was determined to be > 2000 mg/kg bw according to a study performed in agreement with OECD Guideline 401. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is GLP complaint and has Klimisch score of 1. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Substance is an intermediate and only available data need to be submitted. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fb73452-8776-45ad-8ec9-e5376f5a901c/documents/b286a4d0-523a-4bfa-9d3f-ed9d4a980ea6_68d12ed5-99f1-439e-80ff-0665d5e9d00d.html,,,,,, "Carrot, ext.",84929-61-3," Acute toxicity, oral in mice: LD50 > 5000 mg/kg bw (equivalent or similar to OECD 401, non-GLP, K, Rel. 2) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3418d287-c48a-4a9f-9f16-a0768de27c46/documents/163fe544-1e85-4435-a92d-26aaba6f9177_d66081ee-1f77-4c72-90f3-2ad9ba184f68.html,,,,,, "Carrot, ext.",84929-61-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3418d287-c48a-4a9f-9f16-a0768de27c46/documents/163fe544-1e85-4435-a92d-26aaba6f9177_d66081ee-1f77-4c72-90f3-2ad9ba184f68.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Decahydro-2-naphthyl acetate,10519-11-6, The oral LD50 was determined to be >5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d334566-52ee-4433-a89d-ad6ad6c1fd6f/documents/8aef4525-ce4a-447a-b6bb-3cfd4027f24c_5a339d19-951e-4b1b-bbc4-270707912ad9.html,,,,,, Decahydro-2-naphthyl acetate,10519-11-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d334566-52ee-4433-a89d-ad6ad6c1fd6f/documents/8aef4525-ce4a-447a-b6bb-3cfd4027f24c_5a339d19-951e-4b1b-bbc4-270707912ad9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Decahydrospiro[furan-2(3H),5'-[4,7]methano[5H]indene]",68480-11-5, Acute oral toxicity: based on read across information: LD50 > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a9ddd4a-fd81-4901-8255-64ab150ca3b9/documents/8383248d-9b7d-4fb4-95ae-c300a0cea33d_d55df221-c496-4097-9b6f-2a02f0c84b9c.html,,,,,, Decanal,112-31-2,"Repeated dose toxicity - oral route: Sub-chronic NOAEL ≥ 1000 mg/kg bw/day; OECD 408, gavage, rats; Anon., 2024, (Klimisch: rel.1). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd827e05-11de-48aa-afb2-75c48ebe9185/documents/IUC5-8ec50320-eff3-4df3-b2f0-88934fd875cf_e150d5a5-bee7-442c-875f-6813544de399.html,,,,,, Decanal,112-31-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd827e05-11de-48aa-afb2-75c48ebe9185/documents/IUC5-8ec50320-eff3-4df3-b2f0-88934fd875cf_e150d5a5-bee7-442c-875f-6813544de399.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat Decanal,112-31-2,"Acute toxicity via Oral route: LD50(male, rat) = 3.73 mL/kg bw, ca. 3088 mg/kg bw (no guideline, WOE, Rel.4). Combined LD50(rat) > 3332 mg/kg bw (no guideline, WOE, Rel.4). Combined LD50(mouse) > 4175 mg/kg bw (no guideline, WOE, Rel.4). Acute toxicity via Dermal route: LD50(male, rabbit) = 5.04 mL/kg bw, ca. 4173 mg/kg bw (no guideline, K, Rel.2). Acute toxicity via Inhalation route: No mortality was observed up to the highest exposure of 8 hr duration. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd827e05-11de-48aa-afb2-75c48ebe9185/documents/IUC5-73a8b0a6-d99d-4cad-98e0-1dd1e08c0eac_e150d5a5-bee7-442c-875f-6813544de399.html,,,,,, Decanal,112-31-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd827e05-11de-48aa-afb2-75c48ebe9185/documents/IUC5-73a8b0a6-d99d-4cad-98e0-1dd1e08c0eac_e150d5a5-bee7-442c-875f-6813544de399.html,,oral,LD50,"ca.3,088 mg/kg bw",adverse effect observed, Decanal,112-31-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd827e05-11de-48aa-afb2-75c48ebe9185/documents/IUC5-73a8b0a6-d99d-4cad-98e0-1dd1e08c0eac_e150d5a5-bee7-442c-875f-6813544de399.html,,dermal,LD50,"ca.4,173 mg/kg bw",no adverse effect observed, Decane,124-18-5, Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test – NOAEL ≥ 1000 mg/kg for rats (OECD 422) Repeated Dose Oral 90d - NOAEL ≥ 5000 mg/kg bw/day for rats (OECD 408) Repeated Dose Inhalation 90d – NOAEL ≥ 10400 mg/m3 for rats (similar to OECD TG 413) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3f2a1dd-5290-484a-b54b-9be4e4da92e4/documents/84609c59-7b9b-432f-a570-b188947aa806_8d4c8714-a29a-4e51-abc8-079c766fd09e.html,,,,,, Decane,124-18-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3f2a1dd-5290-484a-b54b-9be4e4da92e4/documents/84609c59-7b9b-432f-a570-b188947aa806_8d4c8714-a29a-4e51-abc8-079c766fd09e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat Decane,124-18-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3f2a1dd-5290-484a-b54b-9be4e4da92e4/documents/84609c59-7b9b-432f-a570-b188947aa806_8d4c8714-a29a-4e51-abc8-079c766fd09e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"10,400 mg/m3",,rat Decane,124-18-5, Acute Toxicity-Oral LD50 > 5000 mg/kg in rats (OECD TG 401) Acute Toxicity-Inhalation LC50 > 6100 mg/m3 (OECD TG 403) Acute Toxicity-Dermal LD50 > 3160 mg/kg in rabbits (OECD TG 402) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3f2a1dd-5290-484a-b54b-9be4e4da92e4/documents/a460dd41-5ef2-4683-9f06-dab98c80a3b8_8d4c8714-a29a-4e51-abc8-079c766fd09e.html,,,,,, Decane,124-18-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3f2a1dd-5290-484a-b54b-9be4e4da92e4/documents/a460dd41-5ef2-4683-9f06-dab98c80a3b8_8d4c8714-a29a-4e51-abc8-079c766fd09e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Decane,124-18-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3f2a1dd-5290-484a-b54b-9be4e4da92e4/documents/a460dd41-5ef2-4683-9f06-dab98c80a3b8_8d4c8714-a29a-4e51-abc8-079c766fd09e.html,,dermal,LD50,"3,160 mg/kg bw",no adverse effect observed, Decane,124-18-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3f2a1dd-5290-484a-b54b-9be4e4da92e4/documents/a460dd41-5ef2-4683-9f06-dab98c80a3b8_8d4c8714-a29a-4e51-abc8-079c766fd09e.html,,inhalation,LC50,"6,100 mg/m3",no adverse effect observed, Decanenitrile,1975-78-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49dba737-896c-4e0f-9a5b-9339ae31a640/documents/IUC5-fea84d8b-d488-4e11-a4f3-1b59e6483b8f_aedcf190-8c49-421a-9137-6bdd76cf43c4.html,,oral,LD50,"2,000 ",no adverse effect observed, (E)-4-decenal,65405-70-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c47d1117-036f-40ce-aa98-0ae7f32c2d8f/documents/IUC5-fc339844-6c91-49fe-95cd-41ea77c4b929_be1850e1-8d25-4ca1-8fab-4f122a746393.html,,oral,LD50,"7,000 mg/kg bw",no adverse effect observed, Dec-1-ene,872-05-9," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c566986a-2625-4ab1-a66f-f26bb91e49f7/documents/612daf75-9d0a-41a4-bb63-4603c7c632a3_e502749f-214e-42db-8b19-40783d5bd1c4.html,,,,,, Dec-1-ene,872-05-9,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c566986a-2625-4ab1-a66f-f26bb91e49f7/documents/72a428b0-9f1e-41f3-a976-b8cbf39b08f7_e502749f-214e-42db-8b19-40783d5bd1c4.html,,,,,, Dec-9-en-1-ol,13019-22-2, Acute toxcity: Oral LD50 > 10000 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96cf688f-6022-402c-a413-0e373e5333ac/documents/2459872e-f51d-4a0d-bb69-fb43caba9b6a_2c5d9e75-8a90-4529-aae4-cfbbcb9aeb8a.html,,,,,, Dec-9-en-1-ol,13019-22-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96cf688f-6022-402c-a413-0e373e5333ac/documents/2459872e-f51d-4a0d-bb69-fb43caba9b6a_2c5d9e75-8a90-4529-aae4-cfbbcb9aeb8a.html,,oral,LD50,"10,000 mg/kg bw",adverse effect observed, "Decan-1-ol, ethoxylated",26183-52-8,For the whole category of alcohol ethoxylates (AE) a NOAEL of 500 mg/kg bw/day was established. ,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b3578f7-74e3-49e1-89fd-ec67010705de/documents/e801bd0d-de2e-4b8a-9c5e-a7a2317a5b14_1d2f1956-310f-4364-95e5-1467c85f099c.html,,,,,, "Decan-1-ol, ethoxylated",26183-52-8,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b3578f7-74e3-49e1-89fd-ec67010705de/documents/e801bd0d-de2e-4b8a-9c5e-a7a2317a5b14_1d2f1956-310f-4364-95e5-1467c85f099c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Decan-1-ol, ethoxylated",26183-52-8," Oral (OECD 401), rat: LD50 > 2000 mg/kg bw Dermal (OECD 402), rabbit: LD50 > 2000 mg/kg bw Inhalation (OECD 403), rat, 4 h, (limit test): LC50 > 1600 mg/m³ (maximum technically attainable concentration) ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b3578f7-74e3-49e1-89fd-ec67010705de/documents/47257b69-4537-4591-8b74-742c18226deb_1d2f1956-310f-4364-95e5-1467c85f099c.html,,,,,, "Decan-1-ol, ethoxylated",26183-52-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b3578f7-74e3-49e1-89fd-ec67010705de/documents/47257b69-4537-4591-8b74-742c18226deb_1d2f1956-310f-4364-95e5-1467c85f099c.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Decan-1-ol, ethoxylated",26183-52-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b3578f7-74e3-49e1-89fd-ec67010705de/documents/47257b69-4537-4591-8b74-742c18226deb_1d2f1956-310f-4364-95e5-1467c85f099c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Decan-1-ol, ethoxylated",26183-52-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b3578f7-74e3-49e1-89fd-ec67010705de/documents/47257b69-4537-4591-8b74-742c18226deb_1d2f1956-310f-4364-95e5-1467c85f099c.html,,inhalation,discriminating conc.,"1,600 mg/m3",no adverse effect observed, Decyl acetate,112-17-4, The substance is not acute toxic. The oral LD50 is > 4315 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b31bd4d3-ea5e-4fd6-9050-766ecb249213/documents/3695755c-aca7-4b59-b63f-b367b8df3fdd_df03de3e-03b6-4738-b35e-535d2d2b27b8.html,,,,,, Decyl acetate,112-17-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b31bd4d3-ea5e-4fd6-9050-766ecb249213/documents/3695755c-aca7-4b59-b63f-b367b8df3fdd_df03de3e-03b6-4738-b35e-535d2d2b27b8.html,,oral,LD50,"4,315 mg/kg bw",no adverse effect observed, Decan-1-ol,112-30-1," There is no reliable repeated dose toxicity study available for decan-1-ol (CAS 112-30-1). The results for repeated oral exposure are based on read-across data from a dodecan-1-ol and hexan-1-ol feeding study. These two studies report NOAEL values of 2000 mg/kg bw/day based on an OECD Test Guideline 422 study (Hansen 1992) for dodecan-1-ol, and 1127 mg/kg be/day based on a 13-week oral study in the rat (Scientific Associates Inc., 1966) for hexan-1-ol. In addition a 90-day repeated dose dermal study (Wil Research, 1995) in rats where a multi-constituent solution containing circa 50% decanol (semi-occluded conditions) reported no systemic effects at the highest dose tested. The study did gave rise to marked dermal irritative effect.  It is however important to take into account the different test protocol that was used, that is a subchronic repeated dose dermal study (6 hours/day for 5 days/week during 90 days in rats) compared to an OECD test guideline acute dermal irritation study (4 hours in rabbits). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e4a1d69-df3c-4fd6-9fb7-1c2442883f80/documents/af53ef93-3637-4a28-9053-6905b5bdbdde_9c66e452-47c0-45b4-8232-36545003e1bf.html,,,,,, Decan-1-ol,112-30-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e4a1d69-df3c-4fd6-9fb7-1c2442883f80/documents/af53ef93-3637-4a28-9053-6905b5bdbdde_9c66e452-47c0-45b4-8232-36545003e1bf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,127 mg/kg bw/day",,rat Decan-1-ol,112-30-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e4a1d69-df3c-4fd6-9fb7-1c2442883f80/documents/af53ef93-3637-4a28-9053-6905b5bdbdde_9c66e452-47c0-45b4-8232-36545003e1bf.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat Decan-1-ol,112-30-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e4a1d69-df3c-4fd6-9fb7-1c2442883f80/documents/af53ef93-3637-4a28-9053-6905b5bdbdde_9c66e452-47c0-45b4-8232-36545003e1bf.html,Repeated dose toxicity – local effects,dermal,LOAEL,2.8 mg/cm2,adverse effect observed,rat Decan-1-ol,112-30-1," The key acute oral toxicity study with decan-1-ol in rat, conducted according to a protocol similar to OECD Test Guideline 423 and in compliance with GLP, reports an LD50 value of >5000 mg/kg bw (Eurofins 2009; rel 1). The key acute inhalation toxicity study with decan-1-ol, conducted prior to OECD Test Guideline and GLP, reported an LC50 of >71mg/L in rats, following 1-hour whole body inhalation exposure to the atmosphere generated as a mist (Scientific Associates 1977; rel 2). The key acute dermal toxicity study with decan-1-ol, conducted according to a protocol similar to OECD Test Guideline 402 and in compliance with GLP, reports an LD50 value of >5000 mg/kg bw in rat (Eurofins 2009; rel 1). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e4a1d69-df3c-4fd6-9fb7-1c2442883f80/documents/d60a5828-dd98-4d85-b99c-842e6cf8f877_9c66e452-47c0-45b4-8232-36545003e1bf.html,,,,,, Decan-1-ol,112-30-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e4a1d69-df3c-4fd6-9fb7-1c2442883f80/documents/d60a5828-dd98-4d85-b99c-842e6cf8f877_9c66e452-47c0-45b4-8232-36545003e1bf.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Decan-1-ol,112-30-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e4a1d69-df3c-4fd6-9fb7-1c2442883f80/documents/d60a5828-dd98-4d85-b99c-842e6cf8f877_9c66e452-47c0-45b4-8232-36545003e1bf.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Decan-1-ol,112-30-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e4a1d69-df3c-4fd6-9fb7-1c2442883f80/documents/d60a5828-dd98-4d85-b99c-842e6cf8f877_9c66e452-47c0-45b4-8232-36545003e1bf.html,,inhalation,LC50,"71,000 mg/m3",no adverse effect observed, Decyl laurate,36528-28-6," Oral: read across, OECD 407, rat, NOAEL = 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f5794ed-113e-45f2-8423-c56b587011d8/documents/9c56b740-ae87-46bd-bed8-0e67d09d2b6b_2f3c07f9-5253-4e22-9599-e932e7bd6209.html,,,,,, Decyl laurate,36528-28-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f5794ed-113e-45f2-8423-c56b587011d8/documents/9c56b740-ae87-46bd-bed8-0e67d09d2b6b_2f3c07f9-5253-4e22-9599-e932e7bd6209.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Decyl laurate,36528-28-6," Oral (OECD 401, rat, read across): LD50 > 2000 mg/kg bw Dermal (OECD 402, rat, read across): LD50 > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f5794ed-113e-45f2-8423-c56b587011d8/documents/c063a353-3ba2-4245-a69f-ca88f2d3fef6_2f3c07f9-5253-4e22-9599-e932e7bd6209.html,,,,,, Decyl oleate,3687-46-5,"Study on oral subacute repeated dose toxicity was available for (CAS No.):3687-46-5.Key, Potokar, 1987, Cognis, 28d oral rat, RL2- 1000 mg/ kg bw/ dayThere were no dermal or inhalation repeat dose toxicity studies available for any of the category members. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/942a20ee-57b1-4d5e-82c2-8a87c52559a3/documents/IUC5-f85755ba-e114-4cd1-9489-92a430bf3e5b_4a51c5e9-3abd-4098-938e-8ee295282abb.html,,,,,, Decyl oleate,3687-46-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/942a20ee-57b1-4d5e-82c2-8a87c52559a3/documents/IUC5-f85755ba-e114-4cd1-9489-92a430bf3e5b_4a51c5e9-3abd-4098-938e-8ee295282abb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Decyl oleate,3687-46-5,"All available acute toxicity studies within this category showed that LCAEs are non-toxic via the oral and dermal route.Studies on acute oral toxicity were available for the following members of this category (CAS No.): 3687-46-5 and 95912-87-1.Studies on acute oral toxicity were available for (CAS No.): 3687-46-5: Key, Dufour, 1994, Stearinerie, AOT mouse, RL2 – LD50 oral > 2000 mg/kg bw.Gloxhuber, 1967, Cognis, AOT rat, RL2 –LD50 oral >17000 mg/kg bw. Potokar, 1970, Cognis, AOT, rat, RL2 –LD 50 oral > 8660 mg/kg bw. RA-C, CAS 95912-87-1, Kaestner, 1977, Cognis, AOT rat, RL2-LD50 oral > 5000 mg/ kg bw.RA-C, CAS 3687-46-5, key, Dufour, 1994, Stearinerie, AOT mouse, RL2- LD50 oral > 2000 mg/kg bw.Study on acute dermal toxicity was available for (CAS No.).3687-46-5.Key, Beerens-Heijnen, 2010, Cognis, rat, RL1 –LD50 dermal >2000 mg/ kg bw.There were no acute inhalation toxicity studies available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/942a20ee-57b1-4d5e-82c2-8a87c52559a3/documents/IUC5-d5468d49-ed2a-4db4-bfa3-07f0f869b65c_4a51c5e9-3abd-4098-938e-8ee295282abb.html,,,,,, "N,N-dimethyldecylamine N-oxide",2605-79-0," The key study for the oral route is a 90-day repeated dose oral toxicity study in rats comparable to OECD TG 408 [Hazelton Laboratories (1974)] performed using C12 -14 AO. The NOAEL was 0.1% (in the diet) or 1000 mg AO/kg diet. Using a food consumption factor of 0.088 kg food/kg bw/day for rats of this strain and age, this translates into a delivered dose of 88 mg AO/kg bw/day. This value represents the highest NOAEL below the lowest LOAEL and was selected for use in the risk assessment to characterize the risk of long term systemic toxicity via the oral and (by route to route extrapolation) dermal and inhalation routes. With regard to dermal toxicity, repeated dermal treatment of rats (6 hours/day/5 days/week) for 90 days with the substance at dosage levels of 0.27 % AO and 1.33 % AO revealed local signs of irritation but no effects attributable to direct systemic toxicity. A NOAEL regarding systemic effects was therefore not established. Under the conditions of the study the LOEL for local dermal toxicity (irritation) in mice was determined to be 0.27 % AO. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1db8375f-1c91-488c-9dc9-6580abe9b735/documents/22c7d74e-293a-405a-882c-1b8dbad38708_ec437638-a56b-4e9f-ac4d-19f7fa26c8f0.html,,,,,, "N,N-dimethyldecylamine N-oxide",2605-79-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1db8375f-1c91-488c-9dc9-6580abe9b735/documents/22c7d74e-293a-405a-882c-1b8dbad38708_ec437638-a56b-4e9f-ac4d-19f7fa26c8f0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,88 mg/kg bw/day,,rat "N,N-dimethyldecylamine N-oxide",2605-79-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1db8375f-1c91-488c-9dc9-6580abe9b735/documents/22c7d74e-293a-405a-882c-1b8dbad38708_ec437638-a56b-4e9f-ac4d-19f7fa26c8f0.html,Repeated dose toxicity – local effects,dermal,LOAEL,0.045 mg/cm2,adverse effect observed,mouse "N,N-dimethyldecylamine N-oxide",2605-79-0," Acute oral toxicity: In the key study, performed using C10 AO, the LD50 (rat) was between 300 and 2000 mg AO/kg bw with an LD50 cut-off value of 1000 mg AO/kg bw [Haferkorn J (2012)]. Acute dermal toxicity: One reliable study is available using C10 AO. In this study the reported LD50 (rat) was > 2000 mg AO/kg bw [Haferkorn J (2012)]. Acute inhalation toxicity: No studies are available. The substance is a solid with very low vapour pressure. It is manufactured and supplied as an aqueous solution therefore there is no possibility of exposure to dust. It is used in some spraying applications, but it is expected that inhalation exposure from these applications will be low and hence the dermal route is more relevant. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1db8375f-1c91-488c-9dc9-6580abe9b735/documents/IUC5-70ac1422-f833-47be-b43b-4c62f9f31566_ec437638-a56b-4e9f-ac4d-19f7fa26c8f0.html,,,,,, "N,N-dimethyldecylamine N-oxide",2605-79-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1db8375f-1c91-488c-9dc9-6580abe9b735/documents/IUC5-70ac1422-f833-47be-b43b-4c62f9f31566_ec437638-a56b-4e9f-ac4d-19f7fa26c8f0.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, "N,N-dimethyldecylamine N-oxide",2605-79-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1db8375f-1c91-488c-9dc9-6580abe9b735/documents/IUC5-70ac1422-f833-47be-b43b-4c62f9f31566_ec437638-a56b-4e9f-ac4d-19f7fa26c8f0.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Decane-1,2-diol",1119-86-4,The NOAEL of the 28-day oral repeat dose toxicity study in rats (OECD407) was 100 mg/kg/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e596ecfe-f5b8-45e2-8743-78f748c9ecf0/documents/IUC5-a899a4b3-398c-491e-ba52-87ac332bec34_7be42f4e-5fa4-425e-84f9-f4d122710136.html,,,,,, "Decane-1,2-diol",1119-86-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e596ecfe-f5b8-45e2-8743-78f748c9ecf0/documents/IUC5-a899a4b3-398c-491e-ba52-87ac332bec34_7be42f4e-5fa4-425e-84f9-f4d122710136.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Decane-1,2-diol",1119-86-4,"In regulatory guideline acute toxicity studies, there were no mortalities among 3 male and 3 female animals dosed with a single oral dose of 2000 mg/kg and there were no mortalities among 5 males and 5 females dosed dermally at 2000 mg/kg . ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e596ecfe-f5b8-45e2-8743-78f748c9ecf0/documents/IUC5-afa5ff56-871f-4bca-9daa-9547eb1a880f_7be42f4e-5fa4-425e-84f9-f4d122710136.html,,,,,, "Decane-1,2-diol",1119-86-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e596ecfe-f5b8-45e2-8743-78f748c9ecf0/documents/IUC5-afa5ff56-871f-4bca-9daa-9547eb1a880f_7be42f4e-5fa4-425e-84f9-f4d122710136.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "Decane-1,2-diol",1119-86-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e596ecfe-f5b8-45e2-8743-78f748c9ecf0/documents/IUC5-afa5ff56-871f-4bca-9daa-9547eb1a880f_7be42f4e-5fa4-425e-84f9-f4d122710136.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-decyltetradecanoic acid,93778-52-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d93fa83-b656-427b-b1bb-3eb5acf75842/documents/aa3c62b5-25dc-4fd8-bddf-89d138e227c1_e43a4ac1-f2ba-4226-b847-a1f893137b0a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-decyltetradecanoic acid,93778-52-0,"All acute studies (oral, dermal) showed that the target substance is practically not toxic with LD50 > 2000 mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d93fa83-b656-427b-b1bb-3eb5acf75842/documents/9db55144-1e68-4ad0-87f5-d0578ba658cc_e43a4ac1-f2ba-4226-b847-a1f893137b0a.html,,,,,, 2-decyltetradecanoic acid,93778-52-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d93fa83-b656-427b-b1bb-3eb5acf75842/documents/9db55144-1e68-4ad0-87f5-d0578ba658cc_e43a4ac1-f2ba-4226-b847-a1f893137b0a.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-decyltetradecanoic acid,93778-52-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d93fa83-b656-427b-b1bb-3eb5acf75842/documents/9db55144-1e68-4ad0-87f5-d0578ba658cc_e43a4ac1-f2ba-4226-b847-a1f893137b0a.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-decyltetradecanol,58670-89-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fed219d1-2dd5-4d12-9a23-e0c310735bf3/documents/IUC5-ed4b9740-9465-4729-aa26-71809c2a717f_039b9552-eeb2-49a4-bdff-93d1e3607689.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,>= 839.6 mg/kg bw/day,,rat 2-decyltetradecanol,58670-89-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fed219d1-2dd5-4d12-9a23-e0c310735bf3/documents/IUC5-c8298e7e-087e-468d-b31f-785970ef905a_039b9552-eeb2-49a4-bdff-93d1e3607689.html,,oral,discriminating dose,"39,069 mg/kg bw",no adverse effect observed, 2-decyltetradecanol,58670-89-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fed219d1-2dd5-4d12-9a23-e0c310735bf3/documents/IUC5-c8298e7e-087e-468d-b31f-785970ef905a_039b9552-eeb2-49a4-bdff-93d1e3607689.html,,dermal,discriminating dose,"1,680 mg/kg bw",no adverse effect observed, "3-acetyl-6-methyl-2H-pyran-2,4(3H)-dione",520-45-6," Study 001: rat gavage doses 10 to 300 mg/kg bw/day, 24 doses in 34 days; treatment related mortality and adverse toxicity at 300 mg/kg bw/day. No adverse effects at 0, 10, 30, 100 mg/kg bw/day. NOAEL 100 mg/kg bw/day. Study 002: rat dietary 0.02, 0.05, and 0.10 % (by weight, DHA – equivalent to 200, 500 or 1000 ppm or 16, 39 or 78 mg/kg bw/day). Two-year study, 25 animals/group. No adverse effects. NOEL 1000 ppm (78 mg/kg bw/day). Study 003: monkey (Macaca mulatta) gavage doses 0, 50, 100, 200 or 300 mg/kg bw/day (single animal/group)– DHA equivalent, DHA or DHA-Na dosed. One-year study, for doses up to 100 mg/kg bw/day no adverse toxicity. Adverse toxicity at 200 or 300 mg/kg bw/day. NOAEL 100 mg/kg bw/day. Study 004: rat dietary 2500 ppm for 350 days -12 male rats treated group. Part of the study was designed investigate the adverse effects of 4-(dimethylamino)azobenzene (DAB) and any effects DHA may have on its own or in combination with DAB. DHA had no adverse toxic effects, NOAEL 2500 ppm (equivalent to 250 mg/kg/bw/day). The data suggested that DHA delayed the induction of hepatomas and cholangiocarcinoma’s in rats fed DAB. Study 005: rat dietary 20 mg/day/head (dose in mg/kg not stated), 20 male rats treated 15 weeks with DHA. Transient body weight and food consumption reduced, liver weight increased with concomitant enzyme induction. No NOAEL. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1309b9e-4a21-4d0b-be6e-10bb40e81573/documents/ddf9bff9-6a79-4518-87e3-9b893f7bb9a3_2d979eed-0af0-46e9-8369-bc70fd59d5d4.html,,,,,, "3-acetyl-6-methyl-2H-pyran-2,4(3H)-dione",520-45-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1309b9e-4a21-4d0b-be6e-10bb40e81573/documents/ddf9bff9-6a79-4518-87e3-9b893f7bb9a3_2d979eed-0af0-46e9-8369-bc70fd59d5d4.html,Chronic toxicity – systemic effects,oral,NOAEL,78 mg/kg bw/day,,rat "3-acetyl-6-methyl-2H-pyran-2,4(3H)-dione",520-45-6," Oral LD50 in rats 1480/1620 mg/kg (females/males); range of doses 1000 to 6400 mg/kg bw; significant toxicity at 2000 mg/kg. Dermal LD50 in rabbits >3000 mg/kg; low dose 1000 mg/kg, top dose 5000 mg/kg; one animal died at 5000 mg/kg . ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1309b9e-4a21-4d0b-be6e-10bb40e81573/documents/3c0d2606-8366-4e7f-bdd2-f55e3427d70c_2d979eed-0af0-46e9-8369-bc70fd59d5d4.html,,,,,, "3-acetyl-6-methyl-2H-pyran-2,4(3H)-dione",520-45-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1309b9e-4a21-4d0b-be6e-10bb40e81573/documents/3c0d2606-8366-4e7f-bdd2-f55e3427d70c_2d979eed-0af0-46e9-8369-bc70fd59d5d4.html,,oral,LD50,"1,480 mg/kg bw",adverse effect observed, "3-acetyl-6-methyl-2H-pyran-2,4(3H)-dione",520-45-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1309b9e-4a21-4d0b-be6e-10bb40e81573/documents/3c0d2606-8366-4e7f-bdd2-f55e3427d70c_2d979eed-0af0-46e9-8369-bc70fd59d5d4.html,,dermal,LD50,"3,000 mg/kg bw",adverse effect observed, Decan-5-olide,705-86-2," Repeated dose toxicity: Oral Based on the data available, the No Observed Adverse Effect Level (NOAEL) for the test chemical was considered to be 1000mg/Kg bw using male and female rats. Hence the test chemical is not likely to be toxic upon repeated exposure by oral route as per the criteria mentioned in CLP regulation. Repeated dose toxicity: inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the test chemical which is reported as  mm Hg. Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely. Therefore this study is considered for waiver. Repeated dose toxicity: dermal The acute toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1aca4ad-0e9f-43e9-bbef-beb012c37a79/documents/b4164656-6b26-421e-95bc-b7d94ff30bc6_ad978098-258c-40fb-aa96-bac898bd69a9.html,,,,,, Decan-5-olide,705-86-2," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The studies concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to low vapour pressure of the test chemical, which is reported to be 0.00479 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the given test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1aca4ad-0e9f-43e9-bbef-beb012c37a79/documents/d90e5365-ab49-45aa-b5d2-385f24ca4d5a_ad978098-258c-40fb-aa96-bac898bd69a9.html,,,,,, Decan-5-olide,705-86-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1aca4ad-0e9f-43e9-bbef-beb012c37a79/documents/d90e5365-ab49-45aa-b5d2-385f24ca4d5a_ad978098-258c-40fb-aa96-bac898bd69a9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Decan-5-olide,705-86-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1aca4ad-0e9f-43e9-bbef-beb012c37a79/documents/d90e5365-ab49-45aa-b5d2-385f24ca4d5a_ad978098-258c-40fb-aa96-bac898bd69a9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dodecan-5-olide,713-95-1," Repeated dose toxicity: Oral Based on the data available, the No Observed Adverse Effect Level (NOAEL) for the test chemical was considered to be 1000mg/Kg bw using male and female rats. Hence the test chemical is not likely to be toxic upon repeated exposure by oral route as per the criteria mentioned in CLP regulation. Repeated dose toxicity: inhalation The repeated dose  inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.00099 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. Repeated dose toxicity: dermal The acute toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/371d093a-dd86-421a-b134-55a7f41be1cf/documents/1bd147bb-e3c4-41f5-809d-91feb065f96d_78b3fbfc-90e6-4bbd-ac0d-40aff65ad861.html,,,,,, Dodecan-5-olide,713-95-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/371d093a-dd86-421a-b134-55a7f41be1cf/documents/1bd147bb-e3c4-41f5-809d-91feb065f96d_78b3fbfc-90e6-4bbd-ac0d-40aff65ad861.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dodecan-5-olide,713-95-1," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The studies concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.00099 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the given test chemical. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/371d093a-dd86-421a-b134-55a7f41be1cf/documents/8843f9be-9979-464f-9bf3-efd2da5606c7_78b3fbfc-90e6-4bbd-ac0d-40aff65ad861.html,,,,,, Dodecan-5-olide,713-95-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/371d093a-dd86-421a-b134-55a7f41be1cf/documents/8843f9be-9979-464f-9bf3-efd2da5606c7_78b3fbfc-90e6-4bbd-ac0d-40aff65ad861.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dodecan-5-olide,713-95-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/371d093a-dd86-421a-b134-55a7f41be1cf/documents/8843f9be-9979-464f-9bf3-efd2da5606c7_78b3fbfc-90e6-4bbd-ac0d-40aff65ad861.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Denatonium benzoate,3734-33-6, NOAEL was considered to be 5359.05mg/kg for mice when exposed to denatonium orally for 3 weeks. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8dc6498-f307-411a-a12d-3b5bb26c6f42/documents/5a09ba2f-daee-4109-bfbb-c8891338608f_f895143e-a6af-4b9b-99b5-841d54ae3ac5.html,,,,,, Denatonium benzoate,3734-33-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8dc6498-f307-411a-a12d-3b5bb26c6f42/documents/5a09ba2f-daee-4109-bfbb-c8891338608f_f895143e-a6af-4b9b-99b5-841d54ae3ac5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,535.896 mg/kg bw/day,,mouse Denatonium benzoate,3734-33-6," Acute toxicity: Oral LD50 values were considered to be for all animals 749 mg/kg bw , Males: 841(707-1000) mg/kg bw and Females: 648 (506-832) mg/kg bw, When rat were treated with denatonium benzoate (3734-33-6) orally.   Acute toxicity: Inhalation The median lethal Concentration (LC50) and 95% confidence limits was considered to be0.20 mg/L (0.13 - 0.36) when the male and female Sprague-Dawley rats were treated with Denatonium benzoate ( Bitrex®) by inhalation route. Acute toxicity: Dermal LD50 was considered to be >2000mg/kg body weight. When rats were treated with denatonium benzoate (3734-33-6) by dermal application. Based upon the study results and available information, the substance denatonium benzoate (CAS No 3734-33-6) is expected to show acute toxicity effect by the oral route for category IV as per CLP classification and for by the inhalation route category II and dermal route qualified as not classified as per CLP classification ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8dc6498-f307-411a-a12d-3b5bb26c6f42/documents/a9343cf6-45c2-4ad1-a173-4f7f58d07095_f895143e-a6af-4b9b-99b5-841d54ae3ac5.html,,,,,, Denatonium benzoate,3734-33-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8dc6498-f307-411a-a12d-3b5bb26c6f42/documents/a9343cf6-45c2-4ad1-a173-4f7f58d07095_f895143e-a6af-4b9b-99b5-841d54ae3ac5.html,,oral,LD50,749 mg/kg bw,adverse effect observed, Denatonium benzoate,3734-33-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8dc6498-f307-411a-a12d-3b5bb26c6f42/documents/a9343cf6-45c2-4ad1-a173-4f7f58d07095_f895143e-a6af-4b9b-99b5-841d54ae3ac5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Denatonium benzoate,3734-33-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8dc6498-f307-411a-a12d-3b5bb26c6f42/documents/a9343cf6-45c2-4ad1-a173-4f7f58d07095_f895143e-a6af-4b9b-99b5-841d54ae3ac5.html,,inhalation,LC50,0.2 mg/m3,adverse effect observed, Kerosine (petroleum),8008-20-6,"A number of subacute and subchronic studies with kerosines and jet fuels are available (OECD 410, 412, 413, and other non-guideline protocols). The repeated inhalation and oral studies of kerosine in rats produced no consistent toxicological effects other than changes in male rat kidneys that are not considered relevant to humans. The NOAEC for inhalation exposure is greater than or equal to 1000 mg/m3 (vapour).  The systemic dermal NOAEL is greater than or equal to 495 mg/kg bw/day, based on a well conducted 90-day study in rats.  The NOAEL for systemic effects of oral exposure is 750 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f272449a-6bed-49e6-bea2-f3c349a67d78/documents/89277e09-fd6a-4778-85aa-41521a1ff043_0906198c-3fac-4513-a74e-c46e0bcfa70d.html,,,,,, Kerosine (petroleum),8008-20-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f272449a-6bed-49e6-bea2-f3c349a67d78/documents/89277e09-fd6a-4778-85aa-41521a1ff043_0906198c-3fac-4513-a74e-c46e0bcfa70d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat Kerosine (petroleum),8008-20-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f272449a-6bed-49e6-bea2-f3c349a67d78/documents/89277e09-fd6a-4778-85aa-41521a1ff043_0906198c-3fac-4513-a74e-c46e0bcfa70d.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,495 mg/kg bw/day,,rat Kerosine (petroleum),8008-20-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f272449a-6bed-49e6-bea2-f3c349a67d78/documents/89277e09-fd6a-4778-85aa-41521a1ff043_0906198c-3fac-4513-a74e-c46e0bcfa70d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat Kerosine (petroleum),8008-20-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f272449a-6bed-49e6-bea2-f3c349a67d78/documents/89277e09-fd6a-4778-85aa-41521a1ff043_0906198c-3fac-4513-a74e-c46e0bcfa70d.html,Repeated dose toxicity – local effects,dermal,LOAEL,1 mg/cm2,adverse effect observed,rat Kerosine (petroleum),8008-20-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f272449a-6bed-49e6-bea2-f3c349a67d78/documents/89277e09-fd6a-4778-85aa-41521a1ff043_0906198c-3fac-4513-a74e-c46e0bcfa70d.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,000 mg/m3",no adverse effect observed,rat Kerosine (petroleum),8008-20-6,"Kerosines are of low acute toxicity with mortality rarely reported even at very high exposures in experimental animal studies conducted by oral (similar to OECD 420), dermal (similar to OECD 402), and inhalation (similar to OECD 403) exposure.  • The oral LD50 was > 5000 mg/kg bw in male and female rats for kerosine.• The dermal LD50 was > 2000 mg/kg/bw in male and female rabbits for kerosine.• The inhalation LC50 was > 5.28 mg/L vapour in male and female rats for kerosine. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f272449a-6bed-49e6-bea2-f3c349a67d78/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_0906198c-3fac-4513-a74e-c46e0bcfa70d.html,,,,,, Kerosine (petroleum),8008-20-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f272449a-6bed-49e6-bea2-f3c349a67d78/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_0906198c-3fac-4513-a74e-c46e0bcfa70d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Kerosine (petroleum),8008-20-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f272449a-6bed-49e6-bea2-f3c349a67d78/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_0906198c-3fac-4513-a74e-c46e0bcfa70d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Kerosine (petroleum),8008-20-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f272449a-6bed-49e6-bea2-f3c349a67d78/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_0906198c-3fac-4513-a74e-c46e0bcfa70d.html,,inhalation,LC50,"5,280 mg/m3",no adverse effect observed, "Nuclease, deoxyribo-",9003-98-9,"13-week oral toxicity: The no-observed-adverse-effect level (NOAEL) was considered to be 100% of the Deoxyribonuclease batch PPW70965, 1012.8 mg enzyme concentrate dry matter/kg bw/day.  ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c9509e7-ae38-483d-bda5-309feac22f2e/documents/3caecfe3-6d4d-4150-aacb-a1471dd83cc5_e8933e1c-8344-4ded-857a-d425eb587a0a.html,,,,,, "Nuclease, deoxyribo-",9003-98-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c9509e7-ae38-483d-bda5-309feac22f2e/documents/3caecfe3-6d4d-4150-aacb-a1471dd83cc5_e8933e1c-8344-4ded-857a-d425eb587a0a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,006 mg/kg bw/day",,rat "Nuclease, deoxyribo-",9003-98-9,"The oral administration of Deoxyribonuclease, batch PPW70965 to HanWistar rats at doses up to 100% of the test item, 1012.8 mg enzyme concentrate dry matter/kg bwt/day administered at a dose volume of 10 mL/kg bw/day for 13 weeks was well-tolerated, with no evidence of any adverse finding at any of the administered doses. Consequently, the no-observed-adverse-effect level (NOAEL) was considered to be the highest dose tested, 1012.8 mg enzyme concentrate dry matter/kg bw/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Toxicological data has been generated within the enzyme producing industry during the last 40 years. Substantial documentation on the safety of the production strains have been generated, and the enzyme test materials are thoroughly characterized. High quality studies for all relevant endpoints, in vivo studies as well as in vitro studies, show that industrial enzymes from well-known and well-characterized production strains have very similar safety profiles across the catalytic activities. Read-across can therefore be applied for the majority of toxicological endpoints. The database can thus be considered of high quality. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Toxicological data has been generated within the enzyme producing industry during the last 40 years. Substantial documentation on the safety of the production strains have been generated, and the enzyme test materials are thoroughly characterized. High quality studies for all relevant endpoints, in vivo studies as well as in vitro studies, show that industrial enzymes from well-known and well-characterized production strains have very similar safety profiles across the catalytic activities. Read-across can therefore be applied for the majority of toxicological endpoints. The database can thus be considered of high quality. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c9509e7-ae38-483d-bda5-309feac22f2e/documents/e2cf4abc-bd99-47fe-8254-f9fe8ffe654c_e8933e1c-8344-4ded-857a-d425eb587a0a.html,,,,,, Bis(4-tert-butylcyclohexyl) peroxydicarbonate,15520-11-3,"Two repeated dose toxicity studies are available for the target substance. In a sub-acute 28-day repeated dose toxicity study (OECD 407), the NOAEL was considered to be 500 mg/kg bw/day based on adverse histopathological findings. In a sub-chronic 90-day (OECD 408) repeated dose toxicity study, the NOAEL was considered to be 1000 mg/kg bw/day for females. Due to species-specific findings, which are considered as not relevant for humans, a NOAEL could not be determined for male rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d53bb15f-6be4-430a-aeb2-6b9c0a58a2c0/documents/IUC5-d61ad22d-4c6b-44e6-9f57-66f5c847dce1_6f420c4a-c35e-498e-a4c7-09cc5378ba95.html,,,,,, Bis(4-tert-butylcyclohexyl) peroxydicarbonate,15520-11-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d53bb15f-6be4-430a-aeb2-6b9c0a58a2c0/documents/IUC5-d61ad22d-4c6b-44e6-9f57-66f5c847dce1_6f420c4a-c35e-498e-a4c7-09cc5378ba95.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Bis(4-tert-butylcyclohexyl) peroxydicarbonate,15520-11-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d53bb15f-6be4-430a-aeb2-6b9c0a58a2c0/documents/IUC5-fefd0858-5d0a-42dc-b623-75a874847c4f_6f420c4a-c35e-498e-a4c7-09cc5378ba95.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides",68391-05-9," Overall, as mentioned in the Biocides assessment report available on the read across substance, the main critical effects associated with these substances were due to their corrosive properties. The systemic effects such as the reduction of body weight and food consumption were considered to be secondary compared to the corrosive properties of the substances. Therefore, in the absence of ‘true’ systemic effects and in line with the biocides assessment reports, the derivation of a systemic DNEL has been considered to be non-relevant and only a qualitative local risk assessment has been conducted for the test substance.  ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33f37da1-76cc-455b-b909-c7a93c352b3a/documents/0f000a80-022e-4a01-af57-bfafdc1f65f2_09ed140d-ffee-46ef-84bc-9cf59bd4993f.html,,,,,, "Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides",68391-05-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33f37da1-76cc-455b-b909-c7a93c352b3a/documents/0f000a80-022e-4a01-af57-bfafdc1f65f2_09ed140d-ffee-46ef-84bc-9cf59bd4993f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,dog "Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides",68391-05-9," The oral LD50 value of the test substance was determined to be 720 mg a.i./kg bw in rats, suggesting a moderate acute toxicity potential. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33f37da1-76cc-455b-b909-c7a93c352b3a/documents/c5c10005-fd37-4bca-bc64-e8a08f7213aa_09ed140d-ffee-46ef-84bc-9cf59bd4993f.html,,,,,, "Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides",68391-05-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33f37da1-76cc-455b-b909-c7a93c352b3a/documents/c5c10005-fd37-4bca-bc64-e8a08f7213aa_09ed140d-ffee-46ef-84bc-9cf59bd4993f.html,,oral,LD50,720 mg/kg bw,adverse effect observed, "7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate",72869-86-4," Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, oral (OECD 422), rat: NOAEL = 100 mg/kg bw/day for males NOAEL = 300 mg/kg bw/day for females ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98392ef3-5b3b-4d87-aea9-1af873dc03aa/documents/7688f36c-0fef-48f2-85fd-5ddc8fd61185_d0f4f019-5554-4981-aac7-29b9885c852d.html,,,,,, "7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate",72869-86-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98392ef3-5b3b-4d87-aea9-1af873dc03aa/documents/7688f36c-0fef-48f2-85fd-5ddc8fd61185_d0f4f019-5554-4981-aac7-29b9885c852d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate",72869-86-4," Oral (OECD 401), rat: LD50 > 5000 mg/kg bw Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98392ef3-5b3b-4d87-aea9-1af873dc03aa/documents/IUC5-994fe80b-5703-485e-bbaf-e2d78744517d_d0f4f019-5554-4981-aac7-29b9885c852d.html,,,,,, "7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate",72869-86-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98392ef3-5b3b-4d87-aea9-1af873dc03aa/documents/IUC5-994fe80b-5703-485e-bbaf-e2d78744517d_d0f4f019-5554-4981-aac7-29b9885c852d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "7,7,9(or 7,9,9)-trimethyl-4,13-dioxo-3,14-dioxa-5,12-diazahexadecane-1,16-diyl bismethacrylate",72869-86-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98392ef3-5b3b-4d87-aea9-1af873dc03aa/documents/IUC5-994fe80b-5703-485e-bbaf-e2d78744517d_d0f4f019-5554-4981-aac7-29b9885c852d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Bis[C5-(linear and branched)-alkyl] benzene-1,4-dicarboxylate",2097734-13-7," One repeated dose toxicity study (28 days) according to OECD guideline 422 was conducted with DiPT and revealed no test-item related signs of toxicity. The NOAEL for systematic toxicity is above the highest administered dose 1000 mg test item/kg b.w./day, p.o.. A 90-day Study according to OECD TG 408 was conducted with 100, 300 or 1000 mgDi-(iso)-pentyl terephthalate (DPT)/kg b.w./day. The no-observed-adverse-effect level (NOAEL) was 1000 mg Di-(iso)-pentyl terephthalate (DPT)/kg b.w./day by oral administration for 90 days. The no-observed-effect level (NOEL) was 300 mg (iso)-pentyl terephthalate (DPT)/kg b.w./day by oral administration for 90 days. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0950b1b5-1475-45cf-b8b9-bef07264c418/documents/2511562e-c336-4145-8840-508d02e7a187_bcf20acd-9730-4a6a-abaa-fe50760ce3e0.html,,,,,, "Bis[C5-(linear and branched)-alkyl] benzene-1,4-dicarboxylate",2097734-13-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0950b1b5-1475-45cf-b8b9-bef07264c418/documents/2511562e-c336-4145-8840-508d02e7a187_bcf20acd-9730-4a6a-abaa-fe50760ce3e0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Bis[C5-(linear and branched)-alkyl] benzene-1,4-dicarboxylate",2097734-13-7," Two acute toxicity tests were conducted, an oral and a dermal study. For both exposure routes, the acute oral median lethal dose (LD50) of the test material in rats was estimated to be greater than 2000 mg/kg bodyweight. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0950b1b5-1475-45cf-b8b9-bef07264c418/documents/ef638c82-0927-4a5f-908e-193aebd8c9f3_bcf20acd-9730-4a6a-abaa-fe50760ce3e0.html,,,,,, "Bis[C5-(linear and branched)-alkyl] benzene-1,4-dicarboxylate",2097734-13-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0950b1b5-1475-45cf-b8b9-bef07264c418/documents/ef638c82-0927-4a5f-908e-193aebd8c9f3_bcf20acd-9730-4a6a-abaa-fe50760ce3e0.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Bis[C5-(linear and branched)-alkyl] benzene-1,4-dicarboxylate",2097734-13-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0950b1b5-1475-45cf-b8b9-bef07264c418/documents/ef638c82-0927-4a5f-908e-193aebd8c9f3_bcf20acd-9730-4a6a-abaa-fe50760ce3e0.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)phenol",991-84-4," In a 28day palatabiltiy study with limited examinations a NOAEL was derived at 1010 mg/kg body weight for male rats and 987 mg/kg body weight for female rats (highest concentration tested). In a 90 days subchronic feeding study with rats performed similar to OECD guideline 408, a NOAEL was set at 1297.3 mg/kg body weight in the rat (highest concentration tested). In a second 90day feeding study with dogs a NOAEL was set at 818 mg/kg body weight in the dog (highest concentration tested). No specific systemic toxicity was observed in neither study. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60f05d98-5a8d-4b21-95ac-80198a60e072/documents/IUC5-8d6cecd2-a650-44dc-829b-3ed7aaa9d33b_fa9a1cd2-0de5-4d8b-a15c-f204ee8647fe.html,,,,,, "2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)phenol",991-84-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60f05d98-5a8d-4b21-95ac-80198a60e072/documents/IUC5-8d6cecd2-a650-44dc-829b-3ed7aaa9d33b_fa9a1cd2-0de5-4d8b-a15c-f204ee8647fe.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,297.3 mg/kg bw/day",,rat "2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)phenol",991-84-4," In an acute oral toxicity study, conducted similar to the OECD-Guideline 401, the oral LD50 in rats was determined to be > 3000 mg/kg body weight (no mortality). In an acute inhalation toxicity study similar to OECD-Guideline 403, the inhalative LC50 was determined to be > 1 mg/l (no mortality). In an acute dermal toxicity study following OECD-Guideline 402 the dermal LD50 was determined to be > 1600 mg/kg body weight (no mortality). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60f05d98-5a8d-4b21-95ac-80198a60e072/documents/IUC5-3d472847-8ef8-41e1-8b1f-21671721b853_fa9a1cd2-0de5-4d8b-a15c-f204ee8647fe.html,,,,,, "2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)phenol",991-84-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60f05d98-5a8d-4b21-95ac-80198a60e072/documents/IUC5-3d472847-8ef8-41e1-8b1f-21671721b853_fa9a1cd2-0de5-4d8b-a15c-f204ee8647fe.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, "2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)phenol",991-84-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60f05d98-5a8d-4b21-95ac-80198a60e072/documents/IUC5-3d472847-8ef8-41e1-8b1f-21671721b853_fa9a1cd2-0de5-4d8b-a15c-f204ee8647fe.html,,dermal,LD50,"1,600 mg/kg bw",no adverse effect observed, "2,6-di-tert-butyl-4-(4,6-bis(octylthio)-1,3,5-triazin-2-ylamino)phenol",991-84-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60f05d98-5a8d-4b21-95ac-80198a60e072/documents/IUC5-3d472847-8ef8-41e1-8b1f-21671721b853_fa9a1cd2-0de5-4d8b-a15c-f204ee8647fe.html,,inhalation,LC50,"1,000 mg/m3",no adverse effect observed, "2,5-di-tert-butylhydroquinone",88-58-4, The no-observed-adverse-effect-level (NOAEL) of test item YAPOX 2245 is considered as 50 mg/kg body weight when administered to Sprague Dawely rats by oral gavge ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e12f0b6-f3ec-43de-92fe-c66646d9c4f2/documents/9eed9b80-ba08-457a-a655-5f24e8812b10_8e20ae99-a96f-4098-8a1d-6c23162a8248.html,,,,,, "2,5-di-tert-butylhydroquinone",88-58-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e12f0b6-f3ec-43de-92fe-c66646d9c4f2/documents/9eed9b80-ba08-457a-a655-5f24e8812b10_8e20ae99-a96f-4098-8a1d-6c23162a8248.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "2,5-di-tert-butylhydroquinone",88-58-4, Oral (OECD 420); di-tert-butyl hydroquinone; LD50 50 mg/kg bw Dermal (OECD 402); di-tert-butyl hydroquinone; LD50 > 2 000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e12f0b6-f3ec-43de-92fe-c66646d9c4f2/documents/e9637674-a6af-43d0-b149-b161bd0806d3_8e20ae99-a96f-4098-8a1d-6c23162a8248.html,,,,,, "2,5-di-tert-butylhydroquinone",88-58-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e12f0b6-f3ec-43de-92fe-c66646d9c4f2/documents/e9637674-a6af-43d0-b149-b161bd0806d3_8e20ae99-a96f-4098-8a1d-6c23162a8248.html,,oral,LD50,50 mg/kg bw,adverse effect observed, "2,5-di-tert-butylhydroquinone",88-58-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e12f0b6-f3ec-43de-92fe-c66646d9c4f2/documents/e9637674-a6af-43d0-b149-b161bd0806d3_8e20ae99-a96f-4098-8a1d-6c23162a8248.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-hydroxy-4-methylpentan-2-one,123-42-2," Repeated dose studies with Diacetone alcohol (4-hydroxy-4-methylpentan-2-one) indicated that systemic toxicity is minimal. The NOAEL via oral gavage dosing (13-week study) was established at 600 mg/kg/day for male and female rats, excluding the sex- and species-specific hyaline droplet nephropathy in males in the determination of the NOAEL. There were no organ-specific toxic effects for either chemical relevant for human risk assessment. The NOAEC for subacute inhalation exposure was 4685 mg/m3 (6-weeks study with rats). Oral route OECD 408 study The potential toxicity of diacetone alcohol was evaluated following daily oral administration (gavage) to rats for 13 weeks. On completion of the treatment period, designated animalsof the control- and high-dose groups were held for a 6-week treatment-free period in order to evaluate the reversibility of any findings. The study was performed based on the OECD guideline No. 408 and in compliance with the Good Laboratory Practices. Three groups of 10 (low- and mid-dose groups) or 15 (high-dose group) male and female Sprague-Dawley rats each received the test item by daily oral gavage administration for at least 13 weeks. The test item was administered at 25, 150 and 600 mg/kg/day as a solution in the vehicle (corn oil) under a constant dosage-volume of 5 mL/kg/day. A control group of 15 animals per sex received the vehicle alone under the same experimental conditions. On completion of the treatment period, the animals in each group were sacrificed, with the exception of the recovery animals (last 5 animals per sex in the control and high-dose groups) which were kept for a 6-week treatment-free period. The concentration of the dose formulations was checked in Weeks 1, 4, 9 and 13. The animals were checked at least twice daily during the treatment and treatment-free periods for mortality and morbidity, and once daily for clinical signs. In addition, detailed clinical examinations were performed once before the beginning of the treatment period and then weekly. The body weight was recorded once before the beginning of the treatment period, and then at least once a week during the study as well as food consumption. Functional Observation Battery was evaluated on all main animals once in Week 12. Ophthalmological examinations were performed on all main animals before the beginning of the treatment period and once at the end of the treatment period. Estrous cycle stage was determined on all main females daily for 21 consecutive days at the end of the treatment period and at the end of the treatment-free period for recovery animals. Hematology, blood biochemistry and urinalysis were performed towards the end of thetreatment period for main animals and towards the end of treatment-free period for recovery animals. On completion of the treatment period and treatment-free periods, the animals were euthanized and submitted to a full macroscopic post-mortem examination. Sperm investigations were performed at sacrifice of the males. A microscopic examination was performed on selected tissues from animals of the control- and high-dose groups sacrificed at the end of the treatment period, and on macroscopic lesions, kidneys and adrenals (males only) and liver from animals of the low- and mid-dose groups sacrificed at the end of the treatment period. Kidneys and adrenals (males only) and liver of recovery animals were examined microscopically at the end of the treatment-free period. Males kidney slides immunostained with an antibody for Alpha 2u-globulin protein were also microscopically examined at the end of treatment period. The test item concentrations in the administered dose formulations analyzedin Weeks 1, 4, 9 and 13 were within the acceptance criteria (± 10%) and no test item was detected in control formulations. There were no test item treatment-related deaths or clinical signs. A dose-related increase in horizontal movement and rearing was observed in males during the recording of motor activity. In absence of correlated clinical signs or other findings at the Functional Observation Battery, this was not considered adverse. Non-adverse slightly lower body weight was recorded from Week 10 in males during the treatment period at 600 mg/kg/day. Body weight gain returned to normal at the end of the treatment-free period, suggesting reversibility. No effects on body weight and body weight gain were noted in females. There were no differences in food consumption between control and test item-treated animals during the treatment and treatment-free periods. At the end of the treatment period, a higher number of females given 600 mg/kg/day remained in diestrous for several consecutive days when compared with controls. This was no longer observed at the end of the treatment-free period and was therefore not considered to be adverse. There were no test item-related ophthalmology findings at the end of the treatment period. At hematology at the end of the treatment period, when compared with controls, a slightly higher neutrophil count was noted in males treated at 600 mg/kg/day (+53%). In females, mean red blood cell count was statistically significantly decreased at 150 and 600 mg/kg/day when compared with controls (up to -6%) and was associated with lower hemoglobin (-5%) and packed cell volume (-7%) at 600 mg/kg/day. Lower total white blood cell (-24%) and lymphocyte counts were also noted (-26%) at the highest dose. These findings were not considered to be adverse in view of their amplitude (remained within the physiological range) and were no longer observed at the end of the treatment-free period, suggesting reversibility. At blood biochemistry in both genders, moderately higher cholesterol concentration was noted at 600 mg/kg/day (+40 % for males and +43% for females). In males, a lower inorganic phosphorus concentration was also noted from 150 mg/kg/day (up to -13%), when compared with controls. These findings were not considered to be adverse and recovery was complete at the end of the treatment-free period. At urinalysis, a slight non-adverse decrease of pH values was noted in males at 600 mg/kg/day. Urinary findings were no longer observed at the end of the treatment-free period. At sperm analyses, when compared to controls, there were no effects attributed to the test item treatment. Test item administration at 600 mg/kg/day induced minimal to slight non-adverse centrilobular hepatocellular hypertrophy that correlated with increases in liver weights and with an increase in the incidence of macroscopically accentuated lobular pattern, in both sexes. In the kidneys, in males only, there were increased incidence and severity of tubular hyaline droplets (consistent with a2u-globulin), tubular basophilia and granular casts, from 25 mg/kg/day, which correlated with increased kidney weights. Given the nature and the severity of the microscopic alterations associated with the hyaline deposits (mostly minimal to slight), hyaline droplet accumulation and related renal lesions were considered to be non-adverse, in this study. Moreover, these findings are specific to male rats and non-relevant for humans.  Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) after the 13-week treatment period was established at 600 mg/kg/day. OECD 422 study A repeated dose study according to OECD TG 422 was conducted with Diacetone alcohol (4-hydroxy-4-methyl-2-pentanone) (MHW, 1997a). In this study, 10 rats/sex/group were dosed by gavage with 0, 30, 100, 300, or 1000 mg/kg/day of Diacetone alcohol in distilled water for approximately 45 days. Decreased locomotor activity and stimulation response were observed at 300 and 1000 mg/kg/day for both sexes. Altered blood parameters, dilatation of the distal tubules of the kidneys, hepatocellular hypertrophy, and vacuolization of the zona fasciculata of the adrenals were observed in males from the 1000 mg/kg/day group. Females at 300 mg/kg/day showed dilatation of the distal tubules and fatty degeneration of the proximal tubular epithelium in the kidneys. At 1000 mg/kg/day, female body weight gain was reduced, liver weight was increased, hepatocellular hypertrophy was noted, and kidney lesions similar to those at 300 mg/kg/day were also recorded. In addition, increased incidence and/or severity of hyaline droplets in the tubular epithelium was noted in males at 100 mg/kg/day and greater. The kidney effects observed are suggestive of chronic progressive nephropathy (CPN) and a2u-globulin nephropathy, a condition not relevant for human risk assessment (U. S. EPA. (1991) Alpha2u-globulin: Association with chemically induced renal toxicity and neoplasia in the male rat. Risk Assessment Forum. EPA/625/3-91/019F). Therefore, the NOAEL for this study was 100 mg/kg/day for males and females (excluding the sex- and species-specific hyaline droplet nephropathy observed in the males). MTD study in rabbits The potential toxic effects of diacetone alcohol was evaluated following daily oral administration (gavage) in the non-pregnant female rabbit to establish a Maximum Tolerated Dose (MTD) for an OECD 414 study in this species (Bentz, 2018). Three non-pregnant female New Zealand White rabbits received diacetone alcohol by daily oral gavage for 3 weeks. Diacetone alcohol was administered under a volume of 5 ml/kg at 100 mg/kg/day during the first week, 300 mg/kg/day during the second week and 1000 mg/kg/day during the third week, formulated as a solution in drinking water. The animals were observed at least once daily for morbidity, mortality and clinical signs. Body weight was recorded twice during the acclimation period and then every 1 to 3 days. Food consummption was recorded throughout the treatment period for intervals of 2 to 3 days. On completion of the treatment, animals were euthanized and a post-mortem macroscopic examination of the principal thoracic and abdominal organs was performed No unscheduled death occurred and no clinical signs were observed through the whole treatment period. There were no test item-related effects at 100 and 300 mg/kg/day. During treatment at 1000 mg/kg/day, body weight of the females appeared to be minimally affected (down to -4%), but at the end of the week of treatment 2/3 animals seemed to recover. Food consumption was decreased by -27 to -67%. At necropsy, no findings were observed.  Under the experimental conditions of this study, the Maximum Tolerated Dose (MTD) was established to be over 1000 mg/kg/day. Inhalation route A 6-week whole body inhalation study was conducted with Diacetone alcohol (4-hydroxy-4-methylpentan-2-one) in Wistar rats. Animals were exposed to analytical concentrations of 0, 233, 1041 and 4685 mg/m3 of Diacetone alcohol for 6 hours per day for 5 days per week for 6 weeks (Butterworth et al., 1980). This non-GLP study was equivalent to OECD Test Guideline 412. There were no clinical signs of toxicity in the first four weeks of exposure; however, slight lethargy was noted for a few hours in 233 and 4685 mg/m3 exposed animals over the following 2 weeks. The body weights of females exposed to 4685 mg/m3 were significantly lower (-5%) than controls at week 6. After 2 weeks, food consumption was significantly decreased in males compared to controls; however, this was not noted in subsequent weeks. Haemoglobin was significantly increased (+6%) in females exposed to 4685 mg/m3 compared to controls. Lactate dehydrogenase (LDH) was significantly higher (+48%) in females exposed to 4685 mg/m3 compared to controls. In males, plasma protein was increased (+3%) at the 4685 mg/m3 concentration and plasma sodium was reduced (-0.7%) at all concentrations. Liver and kidney weights were increased in males (compared to controls) exposed to 1041 (liver+13%) and 4685 mg/m3 (liver+23%) and 4685 mg/m3 (kidney +17%), respectively. Histologically, the abnormal presence of eosinophilic hyaline droplets in the proximal tubules of males exposed to the high concentration was noted. There was no suggestion of cellular damage and the response may have been due to cellular accumulation of the chemical or a metabolite. A review of the study data suggests that a NOAEC of 4685 mg/m3 and a NOEC of 1041 mg/m3 can be considered for repeated-dose inhalational toxicity, based on liver weight changes not associated with histological alterations and probably secondary to a metabolic over load and based on the male rat-specific eosinophilic hyaline droplets in the proximal tubular cells as hyaline droplet formation in male rats is not considered to be relevant to human health for the purposes of risk assessment (U. S. EPA, 1991). No irritation of the respiratory tract was observed up to the highest concentration tested. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f588993-ec13-4ad1-9948-634da3166b4f/documents/IUC5-89244a72-a446-4b65-bb50-098825e964fa_1223f520-cbcf-4ebf-9bec-826b0f0b7bee.html,,,,,, 4-hydroxy-4-methylpentan-2-one,123-42-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f588993-ec13-4ad1-9948-634da3166b4f/documents/IUC5-89244a72-a446-4b65-bb50-098825e964fa_1223f520-cbcf-4ebf-9bec-826b0f0b7bee.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"4,685 mg/m3",,rat 4-hydroxy-4-methylpentan-2-one,123-42-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f588993-ec13-4ad1-9948-634da3166b4f/documents/IUC5-89244a72-a446-4b65-bb50-098825e964fa_1223f520-cbcf-4ebf-9bec-826b0f0b7bee.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat 4-hydroxy-4-methylpentan-2-one,123-42-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f588993-ec13-4ad1-9948-634da3166b4f/documents/IUC5-89244a72-a446-4b65-bb50-098825e964fa_1223f520-cbcf-4ebf-9bec-826b0f0b7bee.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"4,685 mg/m3",no adverse effect observed,rat 4-hydroxy-4-methylpentan-2-one,123-42-2," 4-hydroxy-4-methylpentan-2-one is associated with low acute toxicity in rats following oral exposure (LD50= 3002 mg/kg bw), dermal exposure (LD0> 2 ml/kg (equivalent to 1875 mg/kg bw) and inhalation (4-h LC0 > 7.6 mg/L). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f588993-ec13-4ad1-9948-634da3166b4f/documents/IUC5-9a8f3588-d5b5-4786-973f-1aac219238de_1223f520-cbcf-4ebf-9bec-826b0f0b7bee.html,,,,,, 4-hydroxy-4-methylpentan-2-one,123-42-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f588993-ec13-4ad1-9948-634da3166b4f/documents/IUC5-9a8f3588-d5b5-4786-973f-1aac219238de_1223f520-cbcf-4ebf-9bec-826b0f0b7bee.html,,oral,LD50,"3,002 mg/kg bw",adverse effect observed, 4-hydroxy-4-methylpentan-2-one,123-42-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f588993-ec13-4ad1-9948-634da3166b4f/documents/IUC5-9a8f3588-d5b5-4786-973f-1aac219238de_1223f520-cbcf-4ebf-9bec-826b0f0b7bee.html,,dermal,discriminating dose,"1,875 mg/kg bw",no adverse effect observed, 4-hydroxy-4-methylpentan-2-one,123-42-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f588993-ec13-4ad1-9948-634da3166b4f/documents/IUC5-9a8f3588-d5b5-4786-973f-1aac219238de_1223f520-cbcf-4ebf-9bec-826b0f0b7bee.html,,inhalation,discriminating conc.,"7,600 mg/m3",no adverse effect observed, "Diammonium 2,2'-dithiodiacetate",68223-93-8,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyInformation.KeyInformation): Based on read-across form the source substance NaTG, the targes substance DADTDG shows an oral NOAEL of 38 mg/kg bw/day, while the dermal LOAEL for local effects in rats is determinde to be 21 mg/kg bw/day and the dermal NOAEL for systemic effects is determined to be >=341 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4cd66506-e176-48b7-b65d-190101a7be6f/documents/IUC5-f74e0d0f-11a3-493b-a63c-d48e288da42b_37f4fea3-4b9a-4f79-8c0f-ac96df9be65f.html,,,,,, "Diammonium 2,2'-dithiodiacetate",68223-93-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4cd66506-e176-48b7-b65d-190101a7be6f/documents/IUC5-f74e0d0f-11a3-493b-a63c-d48e288da42b_37f4fea3-4b9a-4f79-8c0f-ac96df9be65f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,38 mg/kg bw/day,,rat "Diammonium 2,2'-dithiodiacetate",68223-93-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4cd66506-e176-48b7-b65d-190101a7be6f/documents/IUC5-f74e0d0f-11a3-493b-a63c-d48e288da42b_37f4fea3-4b9a-4f79-8c0f-ac96df9be65f.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,341 mg/kg bw/day,,rat "Diammonium 2,2'-dithiodiacetate",68223-93-8,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyInformation.KeyInformation): Classification as acute tox. 4 based on the determined oral LD50 between 300 and 500 mg/kg bw. Classification criteria for dermal route not met, LD0>2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4cd66506-e176-48b7-b65d-190101a7be6f/documents/IUC5-0944f164-3068-4c54-9943-7ea9eafc25ba_37f4fea3-4b9a-4f79-8c0f-ac96df9be65f.html,,,,,, "Diammonium 2,2'-dithiodiacetate",68223-93-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4cd66506-e176-48b7-b65d-190101a7be6f/documents/IUC5-0944f164-3068-4c54-9943-7ea9eafc25ba_37f4fea3-4b9a-4f79-8c0f-ac96df9be65f.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, "Diammonium 2,2'-dithiodiacetate",68223-93-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4cd66506-e176-48b7-b65d-190101a7be6f/documents/IUC5-0944f164-3068-4c54-9943-7ea9eafc25ba_37f4fea3-4b9a-4f79-8c0f-ac96df9be65f.html,,dermal,LD0,"> 2,000 mg/kg bw",adverse effect observed, "Diammonium [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]ferrate(2-)",85959-68-8," In an extended oral OECD 422 study with the structurally related chelate DTPA-FeHNa male animals were exposed for at least 13 weeks and females for almost 14 weeks. At the high dose level the following effects were observed: soft faeces (both sexes), decreased body weight gain (males), prolonged prothrombin time (males), increased haemoglobin concentration (males), decreased ALAT activity and chloride concentration (males) and increased relative weights of kidneys and liver (both sexes). No toxicologically relevant changes were observed at the lower levels of 500 and 150 mg/kg bw (see also read across document in section 13). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96a8183b-9516-4f22-92f6-6f83c374ff26/documents/IUC5-8deec44f-63e0-473a-abf1-e0c70321830b_8b42e681-c8c9-409c-95ab-a5bdc062f688.html,,,,,, "Diammonium [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]ferrate(2-)",85959-68-8," The oral LD50 value is in excess of 2000 mg/kg bw; the 4-h LC50 value of structurally related substances is in excess of 5 g/m3. No acute dermal toxicity studies are available but based on read across (see also section 13), acute dermal toxicity following exposure to DTPA-Fe(NH4)2 is not expected. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96a8183b-9516-4f22-92f6-6f83c374ff26/documents/IUC5-0066b134-e469-43e0-ad14-7eaf867a1be3_8b42e681-c8c9-409c-95ab-a5bdc062f688.html,,,,,, Diammonium hydrogenorthophosphate,7783-28-0,"Based on a reliable oral OECD 422 study with diammonium hydrogenorthophoshate in rats, local effects were observed in the stomach at the lowest dose tested (250 mg/kg bw/day). However, the systemic NOAEL is determined to be 250 mg/kg bw/day based on horizontal banding of dental surface at mid dose (LOAEL), with effects on haematological and clinical chemistry parameters at highest dose level. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91912366-0b77-4087-99ad-bec4019791d1/documents/IUC5-9b05a3b0-ef7c-4b8a-9089-b5a0d8899fb0_e08577ba-477b-4c99-b910-0df516fc471a.html,,,,,, Diammonium hydrogenorthophosphate,7783-28-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91912366-0b77-4087-99ad-bec4019791d1/documents/IUC5-9b05a3b0-ef7c-4b8a-9089-b5a0d8899fb0_e08577ba-477b-4c99-b910-0df516fc471a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Diammonium hydrogenorthophosphate,7783-28-0,"Based on reliable studies with diammonium hydrogenorthophosphate for acute oral, dermal and inhalation exposure to rats, the oral and dermal LD50 is >2000 mg/kg bw and the LC50 is > 5 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91912366-0b77-4087-99ad-bec4019791d1/documents/IUC5-5b2dc205-ee49-47e9-a930-3cf20d2fd65c_e08577ba-477b-4c99-b910-0df516fc471a.html,,,,,, Diammonium hydrogenorthophosphate,7783-28-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91912366-0b77-4087-99ad-bec4019791d1/documents/IUC5-5b2dc205-ee49-47e9-a930-3cf20d2fd65c_e08577ba-477b-4c99-b910-0df516fc471a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Diammonium hydrogenorthophosphate,7783-28-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91912366-0b77-4087-99ad-bec4019791d1/documents/IUC5-5b2dc205-ee49-47e9-a930-3cf20d2fd65c_e08577ba-477b-4c99-b910-0df516fc471a.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Diammonium hydrogenorthophosphate,7783-28-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91912366-0b77-4087-99ad-bec4019791d1/documents/IUC5-5b2dc205-ee49-47e9-a930-3cf20d2fd65c_e08577ba-477b-4c99-b910-0df516fc471a.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea",78491-02-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): This study using a close chemical analogue found no evidence of systemic toxicity, but Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Due to the number of subchronic and subacute toxicity studies available and the reliability (Klimisch 1) of the selected key subchronic study, overall database quality is high. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30bb6b2b-6d36-451b-93ce-420368dfdb55/documents/IUC5-7611be4e-5af2-4910-8413-6d8a9e98b7d9_8c019bf7-f843-4559-a7a4-d80397f409a4.html,,,,,, "1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea",78491-02-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30bb6b2b-6d36-451b-93ce-420368dfdb55/documents/IUC5-7611be4e-5af2-4910-8413-6d8a9e98b7d9_8c019bf7-f843-4559-a7a4-d80397f409a4.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,200 mg/kg bw/day,,rabbit "1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea",78491-02-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30bb6b2b-6d36-451b-93ce-420368dfdb55/documents/IUC5-7611be4e-5af2-4910-8413-6d8a9e98b7d9_8c019bf7-f843-4559-a7a4-d80397f409a4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea",78491-02-8,Acute oral toxicity to rodents is low: LD50 >2000 mg/kg.Acute dermal toxicity to rabbits is low: LD50 >2000 mg/kg. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30bb6b2b-6d36-451b-93ce-420368dfdb55/documents/IUC5-bada1e86-0974-4c13-8078-22d0bfe53c4e_8c019bf7-f843-4559-a7a4-d80397f409a4.html,,,,,, "1-[1,3-bis(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]-1,3-bis(hydroxymethyl)urea",78491-02-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30bb6b2b-6d36-451b-93ce-420368dfdb55/documents/IUC5-bada1e86-0974-4c13-8078-22d0bfe53c4e_8c019bf7-f843-4559-a7a4-d80397f409a4.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Dibenzyl ether,103-50-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Scientifically acceptable and sufficiend documented for evaluation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/864eddb8-1bfc-4e36-8e29-337db3cb3b9d/documents/IUC5-3fd189d6-0f16-4b47-994a-2e76467d739e_a6392b90-63a8-4db0-8c91-1c595c508822.html,,,,,, Dibenzyl ether,103-50-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/864eddb8-1bfc-4e36-8e29-337db3cb3b9d/documents/IUC5-3fd189d6-0f16-4b47-994a-2e76467d739e_a6392b90-63a8-4db0-8c91-1c595c508822.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,620 mg/kg bw/day,,rat Dibenzyl ether,103-50-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Scientifically acceptable and sufficiend documented for evaluation. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): In this study report, the authors calculated a LD 50 for rabbits higher than 5.15 m/kg (equivalant to 5397 mg/kg bw) in an acute test after an exposure of 24 hours under occlusive conditions to dibenzyl oxide. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/864eddb8-1bfc-4e36-8e29-337db3cb3b9d/documents/IUC5-cb049bd4-2f28-4da2-8d72-b3d841edae26_a6392b90-63a8-4db0-8c91-1c595c508822.html,,,,,, Dibenzyl ether,103-50-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/864eddb8-1bfc-4e36-8e29-337db3cb3b9d/documents/IUC5-cb049bd4-2f28-4da2-8d72-b3d841edae26_a6392b90-63a8-4db0-8c91-1c595c508822.html,,oral,LD50,"3,860 mg/kg bw",adverse effect observed, Dibenzyl ether,103-50-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/864eddb8-1bfc-4e36-8e29-337db3cb3b9d/documents/IUC5-cb049bd4-2f28-4da2-8d72-b3d841edae26_a6392b90-63a8-4db0-8c91-1c595c508822.html,,dermal,LD50,"5,397 mg/kg bw",no adverse effect observed, Bis-O-(benzylidene)-D-glucitol,32647-67-9," The following test data has been used to assess the repeated dose toxicity of the substance. - reading across the results of a 28 -day repeated dose toxicity study conducted on a structurally similar analogue substance. - 3-month subactue toxicity study of substance itself by oral administration to mice and rats. 28 -day repeated dose toxicity study: Source Substance; Gel All DX (EC-413 -110 -2): A 28-day repeated-dose oral toxicity study of the test material followed by a 14-day recovery test was conducted in male and female Crj: CD (SD) rats (6/sex/ group), 5 weeks of age at the start of dosing. The highest dose was set at 1000 mg/kg, and 3 lower doses at 200, 40 and 8 mg/kg. Recovery groups were separately provided for vehicle control and 1000 mg/kg groups. There were no deaths on account of administration of the test material. No abnormalities were noted in general conditions, body weights, food consumption, haematological examinations, blood chemical examinations, urinalysis, necropsy and histopathological examinations. In organ weights, increased absolute and relative liver weights were noted in males of the 1000 mg/kg group. In the recovery test, no abnormalities were noted. In conclusion, No Observed Effect Level of the test material for rats was considered to be 200 mg/kg/day under the conditions tested. The No Observed Adverse Effect Level was considered to be 1000 mg/kg/day. 3-month subactue toxicity study by oral administration to mice and rats: A 3-month subacute (oral feed) study of dibenzyliden sorbitol was conducted in mice and rats, and the following results were obtained. No special changes were noted in the general symptoms, food ingestion volume, water-intake volume, body weight change, urinalysis findings, etc. The blood and serum biochemistry tests indicated significant differences in some parameters both in mice and rats but all these changes were within the physiological range of variation and indicated no relation to the administration of D.B.S. Macroscopic autopsy findings detected some lesions in the kidney, liver, lung and bladder, etc. of some animals but there was no change specifically observed in the dose groups. As to the organ weights, the weight of liver tended to increase slightly but there was no other tendency that was commonly observed in the males and females of mice and rats and that demonstrated a proportionally certain relation to the dose in the remaining organs. As to the histopathological findings, some localized abnormal findings were obtained from the lung, kidney, heart, liver, pancreas and adrenal gland but all of these events occurred as single episodes and there was no specific change to indicate the correlation to the administration of D.B.S. As described in the above, the results of a 3-month subacute toxicity study by oral administration of D.B.S. indicated that dibenzyliden sorbitol was very stable and had hardly any toxicity. The maximum dose that does not demonstrate the toxicity in such case is 3,200 mg/kg/day for the male and female mice, and 2,000 mg/kg/day for the male and female rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/669dfd78-36ff-4bb3-a3d9-921810208034/documents/aed08f04-ebd4-4649-b1dd-f83672fe957e_79542336-5632-4a4d-ac3a-1d6f8491e458.html,,,,,, Bis-O-(benzylidene)-D-glucitol,32647-67-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/669dfd78-36ff-4bb3-a3d9-921810208034/documents/aed08f04-ebd4-4649-b1dd-f83672fe957e_79542336-5632-4a4d-ac3a-1d6f8491e458.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Bis-O-(benzylidene)-D-glucitol,32647-67-9," Acute Oral Toxicity: The study was performed to assess the acute oral toxicity of the test item (EC 251-136-4) in the Wistar strain rat. Following a sighting test at a dose level of 2000 mg/kg, an additional four fasted female animals were given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg body weight. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy.   Results Mortality. There were no deaths. Clinical Observations. There were no signs of systemic toxicity. Body Weight. All animals showed expected gains in body weight. Necropsy. No abnormalities were noted at necropsy. Conclusion The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System-Unclassified). Acute Dermal Toxicity: The acute dermal toxicity of the substance (EC 251-136-4) has been assessed by reading across the results of studies conducted on two structurally similar analogue substances, which are detailed below. Source Substance; Gel All DX (EC-413 -110 -2): A study was performed to assess the acute dermal toxicity of the test material (EC 413-110-2) in the Sprague-Dawley CD strain rat. A group of 10 animals (5 males and 5 females) was given a single 24-hour, semi-occluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight. The animals were observed for 14 days after the day of treatment and were then killed for gross pathological examination. There were no deaths. No signs of systemic toxicity or skin irritation were noted during the study. All animals showed an expected gain in bodyweight during the study. No abnormalities were noted at necropsy. The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be > 2000 mg/kg bodyweight. Source Substance; Gel All MD (EC 402-950-5): The purpose of the study is to determine the acute dermal toxicity of technical GEL-ALL-MD (EC 402-950-5) to the rat. Groups of 5 male and 5 female Sprague-Dawley rats received a single, 24 hour occluded, topical application of 2100 mg Technical Gel-ALL-MD/kg bodyweight, moistened with 0.5% w/v sodium carboxymethylcellulose in distilled water. A further 5 male and 5 female control animals were treated similarly except that no test material was applied to the skin. Animals were observed for 14 days after treatment and then examined post mortem. There were no mortalities, no treatment-related clinical signs and no evidence of skin irritation. No treatment-related effects on bodyweight were recorded and no abnormalities were seen post-mortem. In both sexes the acute dermal LD50 was greater than 2100 mg/kg bw. Acute inhalation toxicity: Study waived for target substance (EC 251-136-4). An acute inhalation study conducted on source substance EC 402-950-5 gave an LC50 (4 hr) >0.67 mg/L air, the maximum attainable concentration. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/669dfd78-36ff-4bb3-a3d9-921810208034/documents/7bdc2ad7-8fcf-4a32-ba3f-1624052365d3_79542336-5632-4a4d-ac3a-1d6f8491e458.html,,,,,, Bis-O-(benzylidene)-D-glucitol,32647-67-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/669dfd78-36ff-4bb3-a3d9-921810208034/documents/7bdc2ad7-8fcf-4a32-ba3f-1624052365d3_79542336-5632-4a4d-ac3a-1d6f8491e458.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Bis-O-(benzylidene)-D-glucitol,32647-67-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/669dfd78-36ff-4bb3-a3d9-921810208034/documents/7bdc2ad7-8fcf-4a32-ba3f-1624052365d3_79542336-5632-4a4d-ac3a-1d6f8491e458.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1'-[methylenebis(oxy)]dibutane",2568-90-3,"OECD TG 408 study available: Toxicity study by oral gavage administration to Crl:CD(SD) rats for 13 weeks Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Endpoint derived by read-across (Klimisch code 2) from an OECD TG 413 (GLP) study with methylal (Hofmann, 1994). RSS of the source test report is provided. RSS of the source subtance is provided. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Reliable study report. Study conducted according to the OECD TG 408 and GLP. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c1452ba-3e7a-4dfd-84ac-141056d76208/documents/IUC5-d15b2926-7206-49f6-b654-0b6ca44a7c95_19155f56-cbd4-4025-976b-8caceed81e44.html,,,,,, "1,1'-[methylenebis(oxy)]dibutane",2568-90-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c1452ba-3e7a-4dfd-84ac-141056d76208/documents/IUC5-d15b2926-7206-49f6-b654-0b6ca44a7c95_19155f56-cbd4-4025-976b-8caceed81e44.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,1'-[methylenebis(oxy)]dibutane",2568-90-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c1452ba-3e7a-4dfd-84ac-141056d76208/documents/IUC5-d15b2926-7206-49f6-b654-0b6ca44a7c95_19155f56-cbd4-4025-976b-8caceed81e44.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"6,300 mg/m3",,rat "1,1'-[methylenebis(oxy)]dibutane",2568-90-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Acute oral toxicity was studied in an OECD 401 and GLP test. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Acute dermal toxicity was studied in an OECD 402 and GLP test. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c1452ba-3e7a-4dfd-84ac-141056d76208/documents/IUC5-d632884c-7c78-41ff-92ad-e1bcc832ebba_19155f56-cbd4-4025-976b-8caceed81e44.html,,,,,, "1,1'-[methylenebis(oxy)]dibutane",2568-90-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c1452ba-3e7a-4dfd-84ac-141056d76208/documents/IUC5-d632884c-7c78-41ff-92ad-e1bcc832ebba_19155f56-cbd4-4025-976b-8caceed81e44.html,,oral,LD50,"6,873 mg/kg bw",no adverse effect observed, "1,1'-[methylenebis(oxy)]dibutane",2568-90-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c1452ba-3e7a-4dfd-84ac-141056d76208/documents/IUC5-d632884c-7c78-41ff-92ad-e1bcc832ebba_19155f56-cbd4-4025-976b-8caceed81e44.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dibutyl adipate,105-99-7,"In conclusion, no human hazard for systemic toxicity after repeated oral, dermal, or inhalation exposure was identified for the PFAE linear category members. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c84bc5df-ecf3-4b38-aeda-a481da3e863f/documents/390b4a39-466d-43dd-8c42-a9f0d373115b_03d49e69-7843-4447-82ed-6c80e49ba2f1.html,,,,,, Dibutyl adipate,105-99-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c84bc5df-ecf3-4b38-aeda-a481da3e863f/documents/390b4a39-466d-43dd-8c42-a9f0d373115b_03d49e69-7843-4447-82ed-6c80e49ba2f1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Dibutyl adipate,105-99-7,All available acute oral toxicity studies within this category resulted in acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.7 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c84bc5df-ecf3-4b38-aeda-a481da3e863f/documents/e6bfb0c8-2974-4ca2-b6d7-9c5da5bdce6a_03d49e69-7843-4447-82ed-6c80e49ba2f1.html,,,,,, 2-dibutylaminoethanol,102-81-8," Repeated dose toxicity: - oral, subacute (OECD407), rat: NOAEL(systemic toxicity; males and females) = 100 mg/kg bw, LOAEL(systemic toxicity) = 400 mg/kg bw (Mortality, depressed body weight gain, decreased food consumption, variations in clinico-chemical parameters and histological changes) - oral,sub-chronic (OECD 408), rat: NOAEL 50 mg/kg bw/day, kidneys: vacuolation of the epithelial cells - inhalative, screening (OECD422), rat: NOAEC(systemic; males and females) = 236.3 mg/m³ (highest dose tested), NOAEC(reproductive and developmental parameters; males and females) = 236.3 mg/m³, NOAEC(local, males and females) = 20.6 mg/m³ ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca12fef0-7c20-495e-84dd-9c8a5a5273bc/documents/IUC5-b41d2b9d-7c14-48b5-a3da-f50e07cb31a0_ac97b36c-e615-4423-a050-7dfb913a4d85.html,,,,,, 2-dibutylaminoethanol,102-81-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca12fef0-7c20-495e-84dd-9c8a5a5273bc/documents/IUC5-b41d2b9d-7c14-48b5-a3da-f50e07cb31a0_ac97b36c-e615-4423-a050-7dfb913a4d85.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,236.3 mg/m3,,rat 2-dibutylaminoethanol,102-81-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca12fef0-7c20-495e-84dd-9c8a5a5273bc/documents/IUC5-b41d2b9d-7c14-48b5-a3da-f50e07cb31a0_ac97b36c-e615-4423-a050-7dfb913a4d85.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 2-dibutylaminoethanol,102-81-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca12fef0-7c20-495e-84dd-9c8a5a5273bc/documents/IUC5-b41d2b9d-7c14-48b5-a3da-f50e07cb31a0_ac97b36c-e615-4423-a050-7dfb913a4d85.html,Repeated dose toxicity – local effects,inhalation,NOAEC,20.6 mg/m3,adverse effect observed,rat 2-dibutylaminoethanol,102-81-8,"- Acute oral toxicity: LD50 > 550 - < 688 mg/kg (rat);- Acute inhalation toxicity: 3 inhalation hazard tests, no mortality (rat);- Acute dermal toxicity: LD50 1680 mg/kg bw (rabbit); ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca12fef0-7c20-495e-84dd-9c8a5a5273bc/documents/IUC5-855d9247-0cf1-4f97-ba58-dbfbd42f3050_ac97b36c-e615-4423-a050-7dfb913a4d85.html,,,,,, 2-dibutylaminoethanol,102-81-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca12fef0-7c20-495e-84dd-9c8a5a5273bc/documents/IUC5-855d9247-0cf1-4f97-ba58-dbfbd42f3050_ac97b36c-e615-4423-a050-7dfb913a4d85.html,,oral,LD50,550 mg/kg bw,adverse effect observed, 2-dibutylaminoethanol,102-81-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca12fef0-7c20-495e-84dd-9c8a5a5273bc/documents/IUC5-855d9247-0cf1-4f97-ba58-dbfbd42f3050_ac97b36c-e615-4423-a050-7dfb913a4d85.html,,dermal,LD50,"1,680 mg/kg bw",adverse effect observed, "(S)-N,N'-dibutyl-2-[(1-oxododecyl)amino]glutaramide",63663-21-8," Key Study (Mihara, 1988) Under the conditions of this study, it was estimated that the LD50 value of the test material is greater than 2.0 g/kg body weight. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6bba77ca-9141-4e87-b374-65e1e393a38c/documents/IUC5-bd2af45a-3ae9-4e2e-991f-9e26cd9bb54b_592dce79-da02-49ff-9217-dbaee47a07f7.html,,,,,, Dibutyl maleate,105-76-0,"Based on a combined repeated dose toxicity study with reproduction/developmental toxicity screening test (OECD 422 and under GLP conditions; RL1)) in rats and a 90-day oral toxicity study (OECD 408 and under GLP conditions), the subchronic oral via gavage LOAEL for systemic toxicity of dibutyl maletae is considered to be 30 mg/kg/day, based on chronic progressive nephropathy and mineralization in the kidneys and increased liver and kidney weights. Repeated dose dermal studies of dibutyl maleate have not been reported.Repeated dose inhalation studies of dibutyl maleate have not been reported. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11dd994e-f8d1-43bb-953d-57006bd233ae/documents/IUC5-e6b3f001-fc9c-4808-94f9-bee99085eaf4_28cc0fbf-ae86-4ad1-b2dd-70ff8aca95cb.html,,,,,, Dibutyl maleate,105-76-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11dd994e-f8d1-43bb-953d-57006bd233ae/documents/IUC5-e6b3f001-fc9c-4808-94f9-bee99085eaf4_28cc0fbf-ae86-4ad1-b2dd-70ff8aca95cb.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,30 mg/kg bw/day,,rat Dibutyl maleate,105-76-0,"Acute toxicity testing by any route (oral, inhalation, and dermal) demonstrate no evidence of toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11dd994e-f8d1-43bb-953d-57006bd233ae/documents/IUC5-44ac449b-8364-49ab-985f-be1aa42e56c3_28cc0fbf-ae86-4ad1-b2dd-70ff8aca95cb.html,,,,,, Dibutyl maleate,105-76-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11dd994e-f8d1-43bb-953d-57006bd233ae/documents/IUC5-44ac449b-8364-49ab-985f-be1aa42e56c3_28cc0fbf-ae86-4ad1-b2dd-70ff8aca95cb.html,,oral,LD50,"3,730 mg/kg bw",, Dibutyl maleate,105-76-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11dd994e-f8d1-43bb-953d-57006bd233ae/documents/IUC5-44ac449b-8364-49ab-985f-be1aa42e56c3_28cc0fbf-ae86-4ad1-b2dd-70ff8aca95cb.html,,dermal,LD50,"2,000 mg/kg bw",, Dibutyl maleate,105-76-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11dd994e-f8d1-43bb-953d-57006bd233ae/documents/IUC5-44ac449b-8364-49ab-985f-be1aa42e56c3_28cc0fbf-ae86-4ad1-b2dd-70ff8aca95cb.html,,inhalation,LC50,"5,000 mg/m3",, Dibutyl phthalate,84-74-2,based ion BASF testing programme ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ac5a3cf-7792-48ce-ab71-72bad67bae5f/documents/3fee5272-3ce5-4314-9eff-5e0754fe0d97_529f0536-1c0a-485d-b064-246b6f152cfd.html,,,,,, Dibutyl phthalate,84-74-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ac5a3cf-7792-48ce-ab71-72bad67bae5f/documents/3fee5272-3ce5-4314-9eff-5e0754fe0d97_529f0536-1c0a-485d-b064-246b6f152cfd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,152 mg/kg bw/day,,rat Dibutyl phthalate,84-74-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ac5a3cf-7792-48ce-ab71-72bad67bae5f/documents/3fee5272-3ce5-4314-9eff-5e0754fe0d97_529f0536-1c0a-485d-b064-246b6f152cfd.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,509 mg/m3,,rat Dibutyl phthalate,84-74-2,see endpoints ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ac5a3cf-7792-48ce-ab71-72bad67bae5f/documents/b3e01d2c-dcde-4ac9-9ced-286b946543d9_529f0536-1c0a-485d-b064-246b6f152cfd.html,,,,,, Dibutyl phthalate,84-74-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ac5a3cf-7792-48ce-ab71-72bad67bae5f/documents/b3e01d2c-dcde-4ac9-9ced-286b946543d9_529f0536-1c0a-485d-b064-246b6f152cfd.html,,oral,LD50,"6,279 mg/kg bw",, Dibutyl phthalate,84-74-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ac5a3cf-7792-48ce-ab71-72bad67bae5f/documents/b3e01d2c-dcde-4ac9-9ced-286b946543d9_529f0536-1c0a-485d-b064-246b6f152cfd.html,,dermal,LD50,"20,000 mg/kg bw",, Dibutyl phthalate,84-74-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ac5a3cf-7792-48ce-ab71-72bad67bae5f/documents/b3e01d2c-dcde-4ac9-9ced-286b946543d9_529f0536-1c0a-485d-b064-246b6f152cfd.html,,inhalation,LC50,4.25 mg/m3,, Dibutyl sebacate,109-43-3,"In conclusion, no human hazard for systemic toxicity after repeated oral, dermal, or inhalation exposure was identified for the PFAE linear category members. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/763ccc41-44cb-4af8-9e08-85789db9f520/documents/IUC5-aa8e4203-6a2c-4f6d-8961-1596a6486f1b_78a945ad-82fb-44ca-b53e-0caffd42129c.html,,,,,, Dibutyl sebacate,109-43-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/763ccc41-44cb-4af8-9e08-85789db9f520/documents/IUC5-aa8e4203-6a2c-4f6d-8961-1596a6486f1b_78a945ad-82fb-44ca-b53e-0caffd42129c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Dibutyl sebacate,109-43-3,All available acute oral toxicity studies within this category resulted in acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.7 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/763ccc41-44cb-4af8-9e08-85789db9f520/documents/IUC5-c25534be-a32d-45f9-8e64-4b2e303fb506_78a945ad-82fb-44ca-b53e-0caffd42129c.html,,,,,, Calcium hydrogenorthophosphate,7757-93-9, There are currently no experimental data available to assess repeated dose toxicity for the test substance. A data waiver is set in place to justify that no further repeated dose toxicity testing is required. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7237df8-4421-4dae-ab01-684e36960bc9/documents/ec8ed222-87b9-4ca3-9f1f-bdb3cb135ee3_07427a74-94b8-489d-bf93-7cd271b03de0.html,,,,,, Calcium hydrogenorthophosphate,7757-93-9," Oral (similar to OECD 401, RL2), rat: LD50 > 3968 mg/kg bw for females, LD 50 > 5000 mg/kg bw for males Dermal (similar to OECD 402, woe, RL2 and 4), rabbit: LD50 > 7940 mg/kg bw (lowest value) Inhalation based on read across from calcium bis(dihydrogenorthophosphate) (OECD 403, RL1), rat: LC50 > 2.6 mg/L air (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7237df8-4421-4dae-ab01-684e36960bc9/documents/62f4e41b-06cc-4d93-8582-052fc6086744_07427a74-94b8-489d-bf93-7cd271b03de0.html,,,,,, Calcium hydrogenorthophosphate,7757-93-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7237df8-4421-4dae-ab01-684e36960bc9/documents/62f4e41b-06cc-4d93-8582-052fc6086744_07427a74-94b8-489d-bf93-7cd271b03de0.html,,oral,LD50,"3,968 mg/kg bw",no adverse effect observed, Calcium hydrogenorthophosphate,7757-93-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7237df8-4421-4dae-ab01-684e36960bc9/documents/62f4e41b-06cc-4d93-8582-052fc6086744_07427a74-94b8-489d-bf93-7cd271b03de0.html,,dermal,LD50,"7,940 mg/kg bw",no adverse effect observed, Calcium hydrogenorthophosphate,7757-93-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7237df8-4421-4dae-ab01-684e36960bc9/documents/62f4e41b-06cc-4d93-8582-052fc6086744_07427a74-94b8-489d-bf93-7cd271b03de0.html,,inhalation,LC50,"2,600 mg/m3",no adverse effect observed, Dioctyl carbonate,1680-31-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aaed6daa-d381-41a1-8108-29be2b391481/documents/67b6647d-d359-44f1-8065-4b63de726ed3_1a8e1896-34f4-413d-b88e-3d2550c0ae85.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dioctyl carbonate,1680-31-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aaed6daa-d381-41a1-8108-29be2b391481/documents/4a72bd58-7f0e-42c5-803b-a6aa97117d51_1a8e1896-34f4-413d-b88e-3d2550c0ae85.html,,oral,LD50,"5,000 mg/kg bw",, Dioctyl carbonate,1680-31-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aaed6daa-d381-41a1-8108-29be2b391481/documents/4a72bd58-7f0e-42c5-803b-a6aa97117d51_1a8e1896-34f4-413d-b88e-3d2550c0ae85.html,,dermal,LD50,"5,000 mg/kg bw",, Dioctyl ether,629-82-3,"repeated dose toxicity (rat, 90 day study): NOAEL > 1000 mg/kg bw ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/61f80c4b-1d36-45df-ab23-8e65ae884162/documents/683a9f30-2f9f-4eba-89d3-7426c9cde8b6_15937d23-2767-48cf-b0f8-04d1b4a3f6cb.html,,,,,, Dioctyl ether,629-82-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/61f80c4b-1d36-45df-ab23-8e65ae884162/documents/683a9f30-2f9f-4eba-89d3-7426c9cde8b6_15937d23-2767-48cf-b0f8-04d1b4a3f6cb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dioctyl ether,629-82-3,acute oral toxicity (rat): LD50 > 2000 mg/kg bw (no mortality)acute dermal toxicity (rat): LD50 > 2000 mg/kg bw (no mortality) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61f80c4b-1d36-45df-ab23-8e65ae884162/documents/84f2e7d6-c34d-49c2-a079-31448be4da07_15937d23-2767-48cf-b0f8-04d1b4a3f6cb.html,,,,,, Dioctyl ether,629-82-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61f80c4b-1d36-45df-ab23-8e65ae884162/documents/84f2e7d6-c34d-49c2-a079-31448be4da07_15937d23-2767-48cf-b0f8-04d1b4a3f6cb.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Dioctyl ether,629-82-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61f80c4b-1d36-45df-ab23-8e65ae884162/documents/84f2e7d6-c34d-49c2-a079-31448be4da07_15937d23-2767-48cf-b0f8-04d1b4a3f6cb.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,4-dichlorobenzyl alcohol",1777-82-8, The test substance was determined to have a NOAEL of 400 mg/kg bw/d in propylene glycol in rats. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ab877d3-37cd-4d05-ae6a-477dce6a29cd/documents/IUC5-5006276b-6301-468f-a28d-bd809bdfa3a1_ed897a90-6e31-49db-9355-3208c7a27d45.html,,,,,, "2,4-dichlorobenzyl alcohol",1777-82-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ab877d3-37cd-4d05-ae6a-477dce6a29cd/documents/IUC5-5006276b-6301-468f-a28d-bd809bdfa3a1_ed897a90-6e31-49db-9355-3208c7a27d45.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat "2,4-dichlorobenzyl alcohol",1777-82-8,"The acute oral LD50 in mice was 2455 mg/kg bw, in ducks > 2510 mg/kg bw and in rats > 3000 and > 4800 mg/kg bw.  The acute inhalation LD50 was > 2.04 mg/L in rats. The acute dermal LD50 was > 2000 mg/kg bw in rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ab877d3-37cd-4d05-ae6a-477dce6a29cd/documents/IUC5-6967dbe5-0717-416e-b6b5-c31c848e2aff_ed897a90-6e31-49db-9355-3208c7a27d45.html,,,,,, "2,4-dichlorobenzyl alcohol",1777-82-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ab877d3-37cd-4d05-ae6a-477dce6a29cd/documents/IUC5-6967dbe5-0717-416e-b6b5-c31c848e2aff_ed897a90-6e31-49db-9355-3208c7a27d45.html,,oral,LD50,"2,455 mg/kg bw",no adverse effect observed, "2,4-dichlorobenzyl alcohol",1777-82-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ab877d3-37cd-4d05-ae6a-477dce6a29cd/documents/IUC5-6967dbe5-0717-416e-b6b5-c31c848e2aff_ed897a90-6e31-49db-9355-3208c7a27d45.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,4-dichlorobenzyl alcohol",1777-82-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ab877d3-37cd-4d05-ae6a-477dce6a29cd/documents/IUC5-6967dbe5-0717-416e-b6b5-c31c848e2aff_ed897a90-6e31-49db-9355-3208c7a27d45.html,,inhalation,LC50,"2,040 mg/m3",adverse effect observed, "Sodium 1,4-dicyclohexyl sulphonatosuccinate",23386-52-9,"Subacute toxicity was tested with the registered substance in Wistar rats by oral gavage at 0 (distilled water), 100, 300 and 1000 mg solid/kg bw/day in a supporting 14-day dose range finding and at 0 (distilled water), 100, 300 and 1000/600 mg solid/kg bw/day in a key combined repeated dose/reproductive toxicity study (OECD No. 422). On day 28 of the dosing period the high dose was reduced to 600 mg/kg bw/day due to mortalities and increasing incidence and severity of noisy/laboured respiration.  The NOAEL for local toxicity of the parental generation was 300 mg solid/kg bw/day (based on noisy/laboured respiration at 600 mg solid/kg bw/day). The NOAEL for systemic toxicity of the parental generation was >= 600 mg solid/kg bw/day.   Subchronic toxicity was tested with read-across substance butanedioic acid, sulfo-, 1,4-bis(1,3-dimethylbutyl) ester, sodium salt (CAS 2373-38-8) in Wistar rats by dietary administration at 0 (control diet), 1500, 3900 and 13000 ppm in a key 90-day repeated dose toxicity study (OECD No. 408). In case of High dose males, the 15000 ppm diet was used from Day 44/45 to Day 90. The NOAEL was 13000 ppm (increased to 15000 ppm in males from day 44/45), corresponding to a mean group test item intake of 870.5 mg/kg bw/day for both sexes (826 mg/kg bw/day in males and 915 mg/kg bw/day in females). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c98b2597-5fef-405a-85a5-db6ee1e76bcf/documents/bfe84fce-fe6f-4a8c-8ecd-68118f4b2686_53f272ae-0dd9-4a02-bcf6-839c18d12b39.html,,,,,, "Sodium 1,4-dicyclohexyl sulphonatosuccinate",23386-52-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c98b2597-5fef-405a-85a5-db6ee1e76bcf/documents/bfe84fce-fe6f-4a8c-8ecd-68118f4b2686_53f272ae-0dd9-4a02-bcf6-839c18d12b39.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,>= 600 mg/kg bw/day,,rat "Sodium 1,4-dicyclohexyl sulphonatosuccinate",23386-52-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c98b2597-5fef-405a-85a5-db6ee1e76bcf/documents/bfe84fce-fe6f-4a8c-8ecd-68118f4b2686_53f272ae-0dd9-4a02-bcf6-839c18d12b39.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,870.5 mg/kg bw/day,,rat "Sodium 1,4-dicyclohexyl sulphonatosuccinate",23386-52-9,"Key studies were performed for oral acute toxicity according to OECD 401 method in male rats, leading to a LD50 of >2830 mg act.ingr./kg bw, and for dermal acute toxicity according to OECD 402 method in male rabbits, demonstrating a LD50 of >4000 mg act.ingr./kg bw. Acute inhalation toxicity was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulfosuccinates due to their substance properties ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c98b2597-5fef-405a-85a5-db6ee1e76bcf/documents/31c1d675-1aa4-4b7f-91ee-5ee484b4ea10_53f272ae-0dd9-4a02-bcf6-839c18d12b39.html,,,,,, "Sodium 1,4-dicyclohexyl sulphonatosuccinate",23386-52-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c98b2597-5fef-405a-85a5-db6ee1e76bcf/documents/31c1d675-1aa4-4b7f-91ee-5ee484b4ea10_53f272ae-0dd9-4a02-bcf6-839c18d12b39.html,,oral,LD50,"2,830 mg/kg bw",no adverse effect observed, "Sodium 1,4-dicyclohexyl sulphonatosuccinate",23386-52-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c98b2597-5fef-405a-85a5-db6ee1e76bcf/documents/31c1d675-1aa4-4b7f-91ee-5ee484b4ea10_53f272ae-0dd9-4a02-bcf6-839c18d12b39.html,,dermal,LD50,"4,000 mg/kg bw",no adverse effect observed, "1-decene, dimer",17438-89-0,"Three read-across 28-day oral exposure studies (OECD 407) and three 90-day oral exposure studies (OECD 408/OECD 415) were identified either within category or from a structural analogue. There were no key dermal or inhalation repeated dose studies identified.Overall, the 28-day exposure studies found no toxicity when the respective poly alpha olefins were administered orally. Results were as follows.• The NOAEL is 6245 mg/kg/day in male rats and 6771 mg/kg/day in female rats for the 28-day oral repeated dose study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1-dodecene dimer with 1-decene, hydrogenated.• The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1 -dodecene, trimer.For the 90-day oral exposure studies, results were as follows.• The NOAEL is 4145.4 mg/kg bw in male rats and 4619.9 mg/kg bw in female rats for the 90-day exposure study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg bw in male and female rats for the 91-day exposure study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg bw in male and female rats for the 90-day one-generation reproduction study with subchronic toxicity from 1 -dodecene, trimer. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d59c5093-7944-4a21-bcd4-ed58c9badf4b/documents/99e8738b-e983-416f-a736-01b102ebd53d_64a7cd03-144b-4834-82d8-6d636c1e96c6.html,,,,,, "1-decene, dimer",17438-89-0,"One key acute oral toxicity studies (16 CFR 1500) and one key acute dermal toxicity study (OECD 402) were identified. Additional read-across studies were identified for numerous poly alpha olefins that showed similar acute oral and dermal toxicity results. Eight key acute inhalation studies (OECD 403) were identified for poly alpha olefins; four of which were for dec-1-ene, dimers, hydrogenated. • The oral LD50 was > 5000 mg/kg bw in male and female rats for dec-1-ene, dimers, hydrogenated; 1-dodecene dimer with 1-decene, hydrogenated; 1-decene trimer, hydrogenated and tetramers; 1-decene, homopolymer, hydrogenated; 1 -dodecene, trimer; and 1 -dodcene, polymer with 1 -decene.• The oral LD50 was > 2000 mg/kg bw in male and female rats for decene trimer hydrogenated.• The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for dec-1-ene, dimers, hydrogenated.• The dermal LD50 was > 2000 mg/kg/bw in male and female rats for both 1 -dodecene dimer with 1 -decene, hydrogenated; 1 -dodecene dimer with 1 -decene, hydrogenated;1 -dodecene, trimer; and 1 -dodecene, polymer with 1 -decene. • The inhalation LC50 values for dec-1 -ene, dimers, hydrogenated in male and female rats were all reported as < 5.0 mg/L.• Dec-1-ene, dimers, hydrogenated is classified for aspiration toxicity based on its kinematic viscosity at 40°C. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d59c5093-7944-4a21-bcd4-ed58c9badf4b/documents/52bb3c38-3146-45ac-ae60-fd9d5f38ea66_64a7cd03-144b-4834-82d8-6d636c1e96c6.html,,,,,, Didecyldimethylammonium chloride,7173-51-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Data published in the DDAC assessment report for Product Type 8 conducted under Directive 98/8/EC (evaluating Competent Authority: Italy, June 2015 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Good quality. In line with the data presented in the DDAC assessment report for Product Type 8 conducted under Directive 98/8/EC (evaluating Competent Authority: Italy, June 2015 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac077f09-fc3c-4e6b-97cf-a375adce402e/documents/IUC5-6c03cd25-d8fc-4d3c-abad-715013ba0f1a_641074fb-9ff7-4fbb-a737-b765ec6d46c5.html,,,,,, Didecyldimethylammonium chloride,7173-51-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac077f09-fc3c-4e6b-97cf-a375adce402e/documents/IUC5-6c03cd25-d8fc-4d3c-abad-715013ba0f1a_641074fb-9ff7-4fbb-a737-b765ec6d46c5.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,12 mg/kg bw/day,, Didecyldimethylammonium chloride,7173-51-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac077f09-fc3c-4e6b-97cf-a375adce402e/documents/IUC5-6c03cd25-d8fc-4d3c-abad-715013ba0f1a_641074fb-9ff7-4fbb-a737-b765ec6d46c5.html,Chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,dog Didecyldimethylammonium chloride,7173-51-5," -         Key value from Registrant: oral LD50 = 264 mg a.i./kg bw (females); dermal LD50 = 3342 mg/kg bw -         Key value from DDAC biocides assessment report for Product Type 8 (June 2015): oral LD50 = 238 mg a.i./kg bw; dermal LD50 = 3342 mg/kg bw In the present report, the oral and dermal LD50 of 238 and 3342 mg a.i./kg bw was selected as key value, in line with the DDAC biocides assessment report for Product Type 8. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac077f09-fc3c-4e6b-97cf-a375adce402e/documents/IUC5-a5c12ecf-cbbe-4d02-8d6f-a451dae6b6d3_641074fb-9ff7-4fbb-a737-b765ec6d46c5.html,,,,,, Didecyldimethylammonium chloride,7173-51-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac077f09-fc3c-4e6b-97cf-a375adce402e/documents/IUC5-a5c12ecf-cbbe-4d02-8d6f-a451dae6b6d3_641074fb-9ff7-4fbb-a737-b765ec6d46c5.html,,oral,LD50,238 mg/kg bw,adverse effect observed, Didecyldimethylammonium chloride,7173-51-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac077f09-fc3c-4e6b-97cf-a375adce402e/documents/IUC5-a5c12ecf-cbbe-4d02-8d6f-a451dae6b6d3_641074fb-9ff7-4fbb-a737-b765ec6d46c5.html,,dermal,LD50,"3,342 mg/kg bw",adverse effect observed, "2,2'-iminodiethanol",111-42-2," Nose-only exposure of rats to DEA aerosols for 3 months (OECD TG 413) resulted in a systemic NOAEC of 15 mg/m³ and the NOAEC for local respiratory tract effects was 3 mg/m³. Repeated unoccluded dermal application of ethanolic DEA solutions in subchronic (13 weeks, protocol similar to OECD TG 411) a NOAEL for systemic effects or local skin irritation could not be achieved (LOAEL 32 mg/kg bw in rats; 80 mg/kg bw in mice). The 2 year dermal studies (NTP, 1999, protocol similar to OECD TG 451) with rats and mice also showed non-carcinogenic effects. Critical effects appear to be kidney (nephropathy) and liver toxicity, anaemia and dermal hyperkeratosis/acanthosis. The overall dermal LOAEL based on the 13 week and 2 years study is concluded to be 8 mg/kg bw/day. In rats, subchronic oral treatment via the drinking water (protocol similar to OECD TG 408) resulted in a LOAEL of 25/14 mg/kg bw (equal to 320/160 ppm) in males/females. In the subchronic oral study in mice a LOAEL of 104/142 mg/kg bw (equal to 630/630 ppm) was noted in males/females. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4140653-157b-48f1-8348-56fcbdfc0e10/documents/IUC5-e16c51ee-e37f-4ec4-b076-87ba002c4bab_2b0dea32-6176-44ef-87fc-614789d21c17.html,,,,,, "2,2'-iminodiethanol",111-42-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4140653-157b-48f1-8348-56fcbdfc0e10/documents/IUC5-e16c51ee-e37f-4ec4-b076-87ba002c4bab_2b0dea32-6176-44ef-87fc-614789d21c17.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,14 mg/kg bw/day,, "2,2'-iminodiethanol",111-42-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4140653-157b-48f1-8348-56fcbdfc0e10/documents/IUC5-e16c51ee-e37f-4ec4-b076-87ba002c4bab_2b0dea32-6176-44ef-87fc-614789d21c17.html,Short-term repeated dose toxicity – systemic effects,dermal,LOAEL,8 mg/kg bw/day,, "2,2'-iminodiethanol",111-42-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4140653-157b-48f1-8348-56fcbdfc0e10/documents/IUC5-e16c51ee-e37f-4ec4-b076-87ba002c4bab_2b0dea32-6176-44ef-87fc-614789d21c17.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,3 mg/m3,, "2,2'-iminodiethanol",111-42-2,"DEA has a moderate acute oral toxicity, while it is considered low after inhalation exposure. For the dermal route, no reliable data is available. As oral and inhalation data are available, no dermal data is required under REACH. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4140653-157b-48f1-8348-56fcbdfc0e10/documents/IUC5-acf1e7b5-ea7c-4454-829a-4d2f195c9ca0_2b0dea32-6176-44ef-87fc-614789d21c17.html,,,,,, Bis(2-ethoxyethyl) ether,112-36-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7871f3a5-e3d4-4b8f-9e76-3253cbd16e66/documents/IUC5-a3e602fe-7edd-418f-a6ea-531cb5dbddc7_4fe615c9-98bd-4cc1-9854-cf1a517f5bdb.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"2,490 mg/m3",,rat Bis(2-ethoxyethyl) ether,112-36-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7871f3a5-e3d4-4b8f-9e76-3253cbd16e66/documents/IUC5-a3e602fe-7edd-418f-a6ea-531cb5dbddc7_4fe615c9-98bd-4cc1-9854-cf1a517f5bdb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Bis(2-ethoxyethyl) ether,112-36-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7871f3a5-e3d4-4b8f-9e76-3253cbd16e66/documents/IUC5-a3e602fe-7edd-418f-a6ea-531cb5dbddc7_4fe615c9-98bd-4cc1-9854-cf1a517f5bdb.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"2,490 mg/m3",no adverse effect observed,rat Diethyl carbonate,105-58-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Publication of acceptable quality. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): No official guideline method but methodology and results well documented, good quality standard. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): OECD 408 study is available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bbeadc40-f106-4920-a2ce-e8f9062b5fcc/documents/IUC5-b9e716a4-8f59-47d8-a33f-eca96f5852bb_562fa922-ca47-4c70-bc8e-6afeae90f543.html,,,,,, Diethyl carbonate,105-58-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bbeadc40-f106-4920-a2ce-e8f9062b5fcc/documents/IUC5-b9e716a4-8f59-47d8-a33f-eca96f5852bb_562fa922-ca47-4c70-bc8e-6afeae90f543.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"48,300 mg/kg bw/day",,mouse Diethyl carbonate,105-58-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bbeadc40-f106-4920-a2ce-e8f9062b5fcc/documents/IUC5-b9e716a4-8f59-47d8-a33f-eca96f5852bb_562fa922-ca47-4c70-bc8e-6afeae90f543.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"18,995 mg/m3",,rat Diethyl carbonate,105-58-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bbeadc40-f106-4920-a2ce-e8f9062b5fcc/documents/IUC5-b9e716a4-8f59-47d8-a33f-eca96f5852bb_562fa922-ca47-4c70-bc8e-6afeae90f543.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Diethyl carbonate,105-58-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Good quality of the data (study report). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Good quality of the data (study report). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbeadc40-f106-4920-a2ce-e8f9062b5fcc/documents/IUC5-3e8c4212-6f3f-4ac9-826c-ef5d0d463715_562fa922-ca47-4c70-bc8e-6afeae90f543.html,,,,,, Diethyl carbonate,105-58-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbeadc40-f106-4920-a2ce-e8f9062b5fcc/documents/IUC5-3e8c4212-6f3f-4ac9-826c-ef5d0d463715_562fa922-ca47-4c70-bc8e-6afeae90f543.html,,oral,LD50,"4,876 mg/kg bw",no adverse effect observed, Diethyl carbonate,105-58-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbeadc40-f106-4920-a2ce-e8f9062b5fcc/documents/IUC5-3e8c4212-6f3f-4ac9-826c-ef5d0d463715_562fa922-ca47-4c70-bc8e-6afeae90f543.html,,inhalation,discriminating conc.,"19,500 mg/m3",no adverse effect observed, Diethyl malonate,105-53-3," A study on dimethyl malonate according to OECD 407 and OECD 422, respectively, is available. Please see the section toxicokinetics/metabolism for the read-across justification. Based on the study results a LOAEL value of 1000 mg/kg bw for both male and female can be stated for dimethyl malonate. Based on the study results a NOAEL value of 300 mg/kg bw for both male and female can be stated for dimethyl malonate. The values are corrected for diethyl malonate by molecular weight correction: M(dimethyl malonate) = 132.1 g/mol M(diethyl malonate) = 160.2 g/mol LOAEL: 1000 mg/kg bw *160.2 g/mol / 132.1 g/mol = 1213 mg/ kg bw NOAEL: 300 mg/kg bw *160.2 g/mol / 132.1 g/mol = 364 mg/ kg bw ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e65dc416-5dc3-46fb-9f63-5cb585f60456/documents/a6b16b62-e259-4607-a485-eba96ea5fff5_d176574a-c750-4071-86ee-0196208cfbba.html,,,,,, Diethyl malonate,105-53-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e65dc416-5dc3-46fb-9f63-5cb585f60456/documents/a6b16b62-e259-4607-a485-eba96ea5fff5_d176574a-c750-4071-86ee-0196208cfbba.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,364 mg/kg bw/day,,rat Diethyl malonate,105-53-3, The LD50 oral value determined by the study is 15.8 g/kg. This value is far above the limit for a classification as acute toxic. It can be concluded based on the study results that the acute dermal toxicity is > 16960 mg/kg bw and thus far above the limit for a classification according to GHS criteria. Exposure of humans is unlikely due to the low vapour pressure of the substance. The oral and dermal routes are considered to be the most relevant exposure routes. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e65dc416-5dc3-46fb-9f63-5cb585f60456/documents/2de36560-3e4f-440c-a0b6-222d0b5a2ad1_d176574a-c750-4071-86ee-0196208cfbba.html,,,,,, Diethyl malonate,105-53-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e65dc416-5dc3-46fb-9f63-5cb585f60456/documents/2de36560-3e4f-440c-a0b6-222d0b5a2ad1_d176574a-c750-4071-86ee-0196208cfbba.html,,oral,LD50,"15,794 mg/kg bw",no adverse effect observed, Diethyl malonate,105-53-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e65dc416-5dc3-46fb-9f63-5cb585f60456/documents/2de36560-3e4f-440c-a0b6-222d0b5a2ad1_d176574a-c750-4071-86ee-0196208cfbba.html,,dermal,LD50,"16,960 mg/kg bw",no adverse effect observed, Diethyl oxalate,95-92-1,The following information is taken into account for any hazard / risk assessment: ​ ​ Key Information: A NOAEL for subacute oral toxicity of 20 mg/kg bw/day was derived from a 28 day toxicity study in rats (according to OECD TG 407; GLP-conform) exposed to the test item. A NOAEL for subchronic oral toxicity of 6 mg/kg bw/day was derived from a 90 day toxicity study in rats (according to OECD TG 408; GLP-conform) exposed to the test item.   ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d10a9437-5c62-4f25-92ab-ca8f64833d61/documents/8ce6e2aa-c70e-4421-8df1-64e9940ee53c_70ed23d8-d4a1-4cec-ac05-447bf6148c6c.html,,,,,, Diethyl oxalate,95-92-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d10a9437-5c62-4f25-92ab-ca8f64833d61/documents/8ce6e2aa-c70e-4421-8df1-64e9940ee53c_70ed23d8-d4a1-4cec-ac05-447bf6148c6c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,6 mg/kg bw/day,,rat Diethyl oxalate,95-92-1,Oral: The acute oral LD50 was determined to be 400 - 1600 mg/kg bw in rats (handbook information) Dermal: The acute dermal LD50 was determined to be > 2000 mg/kg bw in rats.   ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d10a9437-5c62-4f25-92ab-ca8f64833d61/documents/19b79f83-1025-4577-a7b9-b0193d2304f6_70ed23d8-d4a1-4cec-ac05-447bf6148c6c.html,,,,,, Diethyl oxalate,95-92-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d10a9437-5c62-4f25-92ab-ca8f64833d61/documents/19b79f83-1025-4577-a7b9-b0193d2304f6_70ed23d8-d4a1-4cec-ac05-447bf6148c6c.html,,oral,discriminating dose,400 mg/kg bw,adverse effect observed, Diethyl oxalate,95-92-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d10a9437-5c62-4f25-92ab-ca8f64833d61/documents/19b79f83-1025-4577-a7b9-b0193d2304f6_70ed23d8-d4a1-4cec-ac05-447bf6148c6c.html,,dermal,discriminating dose,"2,000 mg/kg bw",adverse effect observed, Diethyl phthalate,84-66-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d411946e-b58c-457c-8ae4-4e3603c33d51/documents/IUC5-3725c309-6802-4b01-9989-eb0c180a35ef_d51e0e4b-f9fe-4869-9a0e-1417914d8167.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Diethyl phthalate,84-66-2,Acute toxicity:Oral - LD50 = > 5 mL/kgInhalatiin - LC50 = > 511 ppmDermal: LD50 = > 10 mL/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d411946e-b58c-457c-8ae4-4e3603c33d51/documents/IUC5-6f157efa-825a-44e6-9fa0-a7ac6d1b29d4_d51e0e4b-f9fe-4869-9a0e-1417914d8167.html,,,,,, Diethyl phthalate,84-66-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d411946e-b58c-457c-8ae4-4e3603c33d51/documents/IUC5-6f157efa-825a-44e6-9fa0-a7ac6d1b29d4_d51e0e4b-f9fe-4869-9a0e-1417914d8167.html,,oral,LD50,"5,591 mg/kg bw",no adverse effect observed, Diethyl phthalate,84-66-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d411946e-b58c-457c-8ae4-4e3603c33d51/documents/IUC5-6f157efa-825a-44e6-9fa0-a7ac6d1b29d4_d51e0e4b-f9fe-4869-9a0e-1417914d8167.html,,dermal,LD50,"11,181 mg/kg bw",no adverse effect observed, Diethyl phthalate,84-66-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d411946e-b58c-457c-8ae4-4e3603c33d51/documents/IUC5-6f157efa-825a-44e6-9fa0-a7ac6d1b29d4_d51e0e4b-f9fe-4869-9a0e-1417914d8167.html,,inhalation,discriminating conc.,"4,640 mg/m3",no adverse effect observed, Diethyl sebacate,110-40-7," Three studies were reported in this evaluation. Therefore, three LD50 were determined. The first experiment was on rats (male/female) and LD50 was 14470mg/kg bw. The second experiment was also on rats (female) and LD50 was 32000 mg/kg bw. The third experiment was on mouse (sex not reported) and LD50 was >32000 mg/kg bw. Therefore, the smallest oral LD50 is used (14470 mg/kg bw). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/466e36c5-cfbd-45d9-af59-35bf5964817b/documents/8c2da2ea-1de7-4b75-98fb-8796bb6ba0fe_e9b238a7-e494-4dcb-9a1c-44ddb31c08da.html,,,,,, Diethyl sebacate,110-40-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/466e36c5-cfbd-45d9-af59-35bf5964817b/documents/8c2da2ea-1de7-4b75-98fb-8796bb6ba0fe_e9b238a7-e494-4dcb-9a1c-44ddb31c08da.html,,oral,LD50,"14,470 mg/kg bw",adverse effect observed, Diethyl succinate,123-25-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf6d847b-b2a5-4e5d-a4cb-8f0e9667f3b2/documents/89c2e443-3b33-4e0d-8199-0ca1922a5fec_4f690abd-a843-4505-b493-b9be6b2d24c6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Diethyl succinate,123-25-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf6d847b-b2a5-4e5d-a4cb-8f0e9667f3b2/documents/6392fbc9-b044-4d98-89cf-98e1caf92f71_4f690abd-a843-4505-b493-b9be6b2d24c6.html,,oral,LD50,"8,530 mg/kg bw",no adverse effect observed, Diethyl succinate,123-25-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf6d847b-b2a5-4e5d-a4cb-8f0e9667f3b2/documents/6392fbc9-b044-4d98-89cf-98e1caf92f71_4f690abd-a843-4505-b493-b9be6b2d24c6.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Diethylamine,109-89-7,"- inhalation: NOAEC (systemic): 125 ppm (male/female), no adverse effects up to the highest tested dose, OECD 422, GLP, K1, 2022 - inhalation: LOAEC (local): 16 ppm (female), OECD 422, GLP, K1, 2022 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af84d53c-e48b-4eb9-97d8-9a2c101349b8/documents/d6326365-17c2-4995-844e-0023a3690301_b872a50e-f6cf-4deb-95ff-8e41a05d2ea2.html,,,,,, Diethylamine,109-89-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af84d53c-e48b-4eb9-97d8-9a2c101349b8/documents/d6326365-17c2-4995-844e-0023a3690301_b872a50e-f6cf-4deb-95ff-8e41a05d2ea2.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,125 ,, Diethylamine,109-89-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af84d53c-e48b-4eb9-97d8-9a2c101349b8/documents/d6326365-17c2-4995-844e-0023a3690301_b872a50e-f6cf-4deb-95ff-8e41a05d2ea2.html,Repeated dose toxicity – local effects,inhalation,LOAEC,16 ,adverse effect observed, Diethylamine,109-89-7,"oral: LD50 = 100 mg/kg bw, similar to OECD 401, non-GLP, K2, rat, 1979 inhalation: LC50 = 17 mg/mL, similar to OECD 403, non-GLP, K2, rat, 1979 dermal: LD50 = 582 mg/kg, similar to Draize method, non-GLP, K2, rabbit, 1950 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af84d53c-e48b-4eb9-97d8-9a2c101349b8/documents/57a0c963-5879-4930-84c6-7782778b3fcf_b872a50e-f6cf-4deb-95ff-8e41a05d2ea2.html,,,,,, Diethylamine,109-89-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af84d53c-e48b-4eb9-97d8-9a2c101349b8/documents/57a0c963-5879-4930-84c6-7782778b3fcf_b872a50e-f6cf-4deb-95ff-8e41a05d2ea2.html,,oral,LD50,100 mg/kg bw,adverse effect observed, Diethylamine,109-89-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af84d53c-e48b-4eb9-97d8-9a2c101349b8/documents/57a0c963-5879-4930-84c6-7782778b3fcf_b872a50e-f6cf-4deb-95ff-8e41a05d2ea2.html,,dermal,LD50,582 mg/kg bw,adverse effect observed, Diethylamine,109-89-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af84d53c-e48b-4eb9-97d8-9a2c101349b8/documents/57a0c963-5879-4930-84c6-7782778b3fcf_b872a50e-f6cf-4deb-95ff-8e41a05d2ea2.html,,inhalation,LC50,"17,300 mg/m3",adverse effect observed, hexyl 2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate,302776-68-7," 90-day repeated dose toxicity (subchronic) study according to OECD TG 408: NOAEL is determined at 15,000 ppm, equivalent to 1248.8 mg/kg bw/day in males and 1452.1 mg/kg bw/day in females. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4593bb8d-1f30-4f2e-8eb7-0545a3fce60c/documents/IUC5-f93cd1d2-421f-4275-94ca-d90965aee474_84e201b4-42bf-45a3-95ad-6a5589aff617.html,,,,,, hexyl 2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate,302776-68-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4593bb8d-1f30-4f2e-8eb7-0545a3fce60c/documents/IUC5-f93cd1d2-421f-4275-94ca-d90965aee474_84e201b4-42bf-45a3-95ad-6a5589aff617.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,249 mg/kg bw/day",, hexyl 2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate,302776-68-7," - Acute oral toxicity studies revealed a LD50 > 2000 mg/ kg bw and no mortality was observed after oral exposure with Hexyl 2-(1-(diethylaminohydroxyphenyl)methanoyl)benzoate (BASF 2003; 10A0636/021054 and supporting study BASF 2000; 10A0408/991123).   - The key study for acute inhalative toxicity study revealed a LC0 = 5.22 mg/L and no mortality was observed after 4h of exposure with Hexyl 2-(1-(diethylaminohydroxyphenyl)methanoyl)benzoate (BASF SE 2017; 13I0636/02X067) Based on the absence of acute oral and inhalative toxicity and the low dermal penetration rate, no acute dermal toxicity is to be expected. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4593bb8d-1f30-4f2e-8eb7-0545a3fce60c/documents/IUC5-a49b1262-8a53-4f08-9ff6-1495fa052fe5_84e201b4-42bf-45a3-95ad-6a5589aff617.html,,,,,, hexyl 2-[4-(diethylamino)-2-hydroxybenzoyl]benzoate,302776-68-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4593bb8d-1f30-4f2e-8eb7-0545a3fce60c/documents/IUC5-a49b1262-8a53-4f08-9ff6-1495fa052fe5_84e201b4-42bf-45a3-95ad-6a5589aff617.html,,oral,LD50,"2,000 mg/kg bw",, 7-(diethylamino)-4-methyl-2-benzopyrone,91-44-1," Repeated dose toxicity: Oral No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg body weight, when rats were treated with the given test chemical via oral route. Repeated dose toxicity: Inhalation A short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment.7-Diethylamino-4-methylcoumarin (CAS no 91-44-1) has very low vapor pressure of 0.00257 Pa. (1.92765825e-5 mmHg), so the potential for the generation of inhalable vapours is very low, also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route of exposure was considered for waiver. Repeated dose toxicity: Dermal A short-term toxicity study does not need to be conducted because exposure of humans via dermal in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the acute dermal toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4ede481-8011-4d65-ab66-922aa97d28f3/documents/a33a684c-a81f-435d-9f72-6f37907dc568_3a06f126-db5a-4a1d-975c-f608f871be2e.html,,,,,, 7-(diethylamino)-4-methyl-2-benzopyrone,91-44-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4ede481-8011-4d65-ab66-922aa97d28f3/documents/a33a684c-a81f-435d-9f72-6f37907dc568_3a06f126-db5a-4a1d-975c-f608f871be2e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 7-(diethylamino)-4-methyl-2-benzopyrone,91-44-1," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is 5000 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to low vapour pressure of the test chemical, which is reported to be 0.00257 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4ede481-8011-4d65-ab66-922aa97d28f3/documents/8c60332c-944d-4c16-854c-51dac16fdf0a_3a06f126-db5a-4a1d-975c-f608f871be2e.html,,,,,, 7-(diethylamino)-4-methyl-2-benzopyrone,91-44-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4ede481-8011-4d65-ab66-922aa97d28f3/documents/8c60332c-944d-4c16-854c-51dac16fdf0a_3a06f126-db5a-4a1d-975c-f608f871be2e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 7-(diethylamino)-4-methyl-2-benzopyrone,91-44-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4ede481-8011-4d65-ab66-922aa97d28f3/documents/8c60332c-944d-4c16-854c-51dac16fdf0a_3a06f126-db5a-4a1d-975c-f608f871be2e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Diethylbenzene,25340-17-4,A number of oral and inhalation repeated dose studies in rats. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c5fc1c67-3295-4a3d-afd9-86ef9b0c32ab/documents/IUC5-9d60e5ef-cd24-4456-acbe-0d10ffadd585_ff770bd3-941b-4e3f-9a01-75748928ec5f.html,,,,,, Diethylbenzene,25340-17-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c5fc1c67-3295-4a3d-afd9-86ef9b0c32ab/documents/IUC5-9d60e5ef-cd24-4456-acbe-0d10ffadd585_ff770bd3-941b-4e3f-9a01-75748928ec5f.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,190 mg/m3,,rat Diethylbenzene,25340-17-4,"Acute oral, dermal and inhalation toxicity studies using mixed DEB. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5fc1c67-3295-4a3d-afd9-86ef9b0c32ab/documents/IUC5-586f7b7a-c5de-4c0f-b525-c34d40007f33_ff770bd3-941b-4e3f-9a01-75748928ec5f.html,,,,,, Diethylbenzene,25340-17-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5fc1c67-3295-4a3d-afd9-86ef9b0c32ab/documents/IUC5-586f7b7a-c5de-4c0f-b525-c34d40007f33_ff770bd3-941b-4e3f-9a01-75748928ec5f.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Diethylbenzene,25340-17-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5fc1c67-3295-4a3d-afd9-86ef9b0c32ab/documents/IUC5-586f7b7a-c5de-4c0f-b525-c34d40007f33_ff770bd3-941b-4e3f-9a01-75748928ec5f.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Diethylbenzene,25340-17-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5fc1c67-3295-4a3d-afd9-86ef9b0c32ab/documents/IUC5-586f7b7a-c5de-4c0f-b525-c34d40007f33_ff770bd3-941b-4e3f-9a01-75748928ec5f.html,,inhalation,LC50,"> 2,100 ",no adverse effect observed, "2,2'-oxydiethanol",111-46-6," In an oral study on rats (Gaunt, 1976) a NOAEL of 300 mg/kg bw/day was determined from a 98-days experiment. After prolonged exposure of 225 days effects on kidney were already seen in dose groups at 300 mg/kg bw/day. Vacuolization of the tubular epithelium (hydropic degeneration) and tubular necrosis were the histopathological findings. For the crystaluria and increased urine volumes after concentration tests, the results in the male and the female rats were inconsistent, and no clear dose-response relationships was observed for these effects. Therefore, the evaluation is based on the histopathological findings. Hydropic degeneration of the kidneys started to occur at oral dose levels of 1550 mg/kg bw/day for 14 weeks and was not seen at 300 mg/kg bw/day. The conclusion is that the NOAEL for hydropic degeneration is 300 mg/kg bw/day (0.4% 2,2’-oxydiethanol in food) in the male rats. The dermal NOAELwas determined to be 2200 mg/kg bw/day, based on a study performed with a structural analogue of DEG in which dogs were exposed for weeks. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/037beccb-d4d4-4687-b381-8b1cfd413206/documents/a64db4a2-3868-4c77-a302-b128b34120f4_56836f93-46d7-4a3e-851f-89a82e3ad309.html,,,,,, "2,2'-oxydiethanol",111-46-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/037beccb-d4d4-4687-b381-8b1cfd413206/documents/a64db4a2-3868-4c77-a302-b128b34120f4_56836f93-46d7-4a3e-851f-89a82e3ad309.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"4,440 mg/kg bw/day",,dog "2,2'-oxydiethanol",111-46-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/037beccb-d4d4-4687-b381-8b1cfd413206/documents/a64db4a2-3868-4c77-a302-b128b34120f4_56836f93-46d7-4a3e-851f-89a82e3ad309.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2,2'-oxydiethanol",111-46-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/037beccb-d4d4-4687-b381-8b1cfd413206/documents/a64db4a2-3868-4c77-a302-b128b34120f4_56836f93-46d7-4a3e-851f-89a82e3ad309.html,Repeated dose toxicity – local effects,inhalation,NOAEC,120 mg/m3,adverse effect observed,other:human "2,2'-oxydiethanol",111-46-6, An oral lethal dose for humans was determined to be 0.014 mg/kg bw. The dermal LD50 for rabbits was determined to be 13330 mg/kg bw. The inhalation LC50 for rats was determined to be 4.6 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/037beccb-d4d4-4687-b381-8b1cfd413206/documents/63f2d556-bc25-41e1-b029-2c03f63f7578_56836f93-46d7-4a3e-851f-89a82e3ad309.html,,,,,, "2,2'-oxydiethanol",111-46-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/037beccb-d4d4-4687-b381-8b1cfd413206/documents/63f2d556-bc25-41e1-b029-2c03f63f7578_56836f93-46d7-4a3e-851f-89a82e3ad309.html,,dermal,LD50,"13,330 mg/kg bw",no adverse effect observed, "2,2'-oxydiethanol",111-46-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/037beccb-d4d4-4687-b381-8b1cfd413206/documents/63f2d556-bc25-41e1-b029-2c03f63f7578_56836f93-46d7-4a3e-851f-89a82e3ad309.html,,inhalation,discriminating conc.,4.6 ,no adverse effect observed, Oxydiethylene dibenzoate,120-55-8,"A 13 -week repeated oral dose (dietary) study (OECD & GLP) was conducted to determine the effects of prolonged exposure on rats of the test material DEGDB.  Groups of ten rats were dosed by dietary administration with DEGDB for a period of 13 weeks at levels 0 (untreated diet control), 250, 1000, 1750, and 2500 mg/kgbw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3dec02b2-8077-4533-b9e9-a48e8721693b/documents/IUC5-b7ec829e-a9fc-4c88-81cd-b8c15dd2498a_4418d2a8-cbb2-443d-98e4-79eeec13a354.html,,,,,, Oxydiethylene dibenzoate,120-55-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3dec02b2-8077-4533-b9e9-a48e8721693b/documents/IUC5-b7ec829e-a9fc-4c88-81cd-b8c15dd2498a_4418d2a8-cbb2-443d-98e4-79eeec13a354.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Oxydiethylene dibenzoate,120-55-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3dec02b2-8077-4533-b9e9-a48e8721693b/documents/IUC5-65909925-49ea-4e7b-9995-55dc5ad3a024_4418d2a8-cbb2-443d-98e4-79eeec13a354.html,,oral,LD50,"3,000 mg/kg bw",, Oxydiethylene dibenzoate,120-55-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3dec02b2-8077-4533-b9e9-a48e8721693b/documents/IUC5-65909925-49ea-4e7b-9995-55dc5ad3a024_4418d2a8-cbb2-443d-98e4-79eeec13a354.html,,dermal,LD50,"2,000 mg/kg bw",, Oxydiethylene dibenzoate,120-55-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3dec02b2-8077-4533-b9e9-a48e8721693b/documents/IUC5-65909925-49ea-4e7b-9995-55dc5ad3a024_4418d2a8-cbb2-443d-98e4-79eeec13a354.html,,inhalation,LC50,0.2 mg/m3,, "Oxydi-2,1-ethanediyl bismethacrylate",2358-84-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/794b1247-a153-40c5-b6db-68d071d15617/documents/a3e52fd7-b2a2-4a5e-94d2-856334f60561_d4eea08a-260a-4cf9-bd3c-9a4df7ebe6f0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,500 mg/kg bw/day",,rat "Oxydi-2,1-ethanediyl bismethacrylate",2358-84-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/794b1247-a153-40c5-b6db-68d071d15617/documents/06b4de6d-5429-40e7-8727-605549d1d1f8_d4eea08a-260a-4cf9-bd3c-9a4df7ebe6f0.html,,oral,LD50,"3,790 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, esters with diethylene glycol",68153-38-8," Information is available on the oral repeated dose toxicity of Rosin esters (simple, linear, and bulky). No treatment-related or biologically relevant findings were apparent in rats following oral sub-chronic dietary exposure to Resin acids and rosin acids, esters with glycerol, Resin acids and rosin acids, esters with ethylene glycol, Resin acids and rosin acids, esters with triethylene glycol, Resin acids and rosin acids, hydrogenated, esters with glycerol and Resin acids and rosin acids, hydrogenated, esters with pentaerythritol. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10568c8f-f4b3-4ce1-a551-34a5b5ec6337/documents/1715a0a9-7d3b-4e03-b1b8-c069ca22d33f_07ecc18f-138b-4fed-af94-f53982a21519.html,,,,,, "Resin acids and Rosin acids, esters with diethylene glycol",68153-38-8,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10568c8f-f4b3-4ce1-a551-34a5b5ec6337/documents/f481cfce-ff08-48a3-8f61-85d6f9c268fd_07ecc18f-138b-4fed-af94-f53982a21519.html,,,,,, "Resin acids and Rosin acids, esters with diethylene glycol",68153-38-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10568c8f-f4b3-4ce1-a551-34a5b5ec6337/documents/f481cfce-ff08-48a3-8f61-85d6f9c268fd_07ecc18f-138b-4fed-af94-f53982a21519.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, esters with diethylene glycol",68153-38-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10568c8f-f4b3-4ce1-a551-34a5b5ec6337/documents/f481cfce-ff08-48a3-8f61-85d6f9c268fd_07ecc18f-138b-4fed-af94-f53982a21519.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2'-iminodi(ethylamine)",111-40-0,Repeat dose toxicity studies include a 90-day (subchronic) dietary toxicity study with the dichloride salt of diethylenetriamine (DETA) in Albino Rats and a 7 day oral gavage study in rats and 7 day dietary study.One chronic dermal study in rats was evaluated where DETA was applied throughout the lifetime of the animal One subacute inhalation toxicity study in rats. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34a048d7-5d22-4e6b-a3c4-8a72ec01c906/documents/IUC5-57e2c7a7-c5a1-4cfc-abde-765e1d351a7b_a435b991-afb0-4ec6-89a4-d2608e78cda2.html,,,,,, "2,2'-iminodi(ethylamine)",111-40-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34a048d7-5d22-4e6b-a3c4-8a72ec01c906/documents/IUC5-57e2c7a7-c5a1-4cfc-abde-765e1d351a7b_a435b991-afb0-4ec6-89a4-d2608e78cda2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,70 mg/kg bw/day,, "2,2'-iminodi(ethylamine)",111-40-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34a048d7-5d22-4e6b-a3c4-8a72ec01c906/documents/IUC5-57e2c7a7-c5a1-4cfc-abde-765e1d351a7b_a435b991-afb0-4ec6-89a4-d2608e78cda2.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,114 mg/kg bw/day,, "2,2'-iminodi(ethylamine)",111-40-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34a048d7-5d22-4e6b-a3c4-8a72ec01c906/documents/IUC5-57e2c7a7-c5a1-4cfc-abde-765e1d351a7b_a435b991-afb0-4ec6-89a4-d2608e78cda2.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,550 mg/m3,, "2,2'-iminodi(ethylamine)",111-40-0,"Oral acute toxicityOne key study and three supporting studies were found to determine the acute oral toxicity of diethylene triamine in the rat.Acute inhalation toxicityTwo acute inhalations: one using Fischer 344 rats exposed to aerolosize diethylene triamine the other exposing rats to substantially saturated vapors of diethylene triamine at 23 degrees C for 8 hours. Acute dermal toxicityTwo studies, one key and the other supporting were conducted to determine the dermal LD50 in rabbits for diethylene triamine. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34a048d7-5d22-4e6b-a3c4-8a72ec01c906/documents/IUC5-1f1500c0-d9da-469d-9ad8-875e8b96ccf7_a435b991-afb0-4ec6-89a4-d2608e78cda2.html,,,,,, "2,2'-iminodi(ethylamine)",111-40-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34a048d7-5d22-4e6b-a3c4-8a72ec01c906/documents/IUC5-1f1500c0-d9da-469d-9ad8-875e8b96ccf7_a435b991-afb0-4ec6-89a4-d2608e78cda2.html,,oral,LD50,"1,553 mg/kg bw",, "2,2'-iminodi(ethylamine)",111-40-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34a048d7-5d22-4e6b-a3c4-8a72ec01c906/documents/IUC5-1f1500c0-d9da-469d-9ad8-875e8b96ccf7_a435b991-afb0-4ec6-89a4-d2608e78cda2.html,,dermal,LD50,"1,045 mg/kg bw",, "2,2'-iminodi(ethylamine)",111-40-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34a048d7-5d22-4e6b-a3c4-8a72ec01c906/documents/IUC5-1f1500c0-d9da-469d-9ad8-875e8b96ccf7_a435b991-afb0-4ec6-89a4-d2608e78cda2.html,,inhalation,,70 mg/m3,, "[[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetrakisphosphonic acid",15827-60-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6883b38-dae5-4d0a-b45a-10e75e435cf7/documents/10a2783d-f133-47b9-909d-8439707d9e96_7b646454-bca3-48b9-a3c3-7489c99df8c6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,82.5 mg/kg bw/day,, "[[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetrakisphosphonic acid",15827-60-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6883b38-dae5-4d0a-b45a-10e75e435cf7/documents/7b645297-fdfb-4941-9bc1-cccd1edc033f_7b646454-bca3-48b9-a3c3-7489c99df8c6.html,,oral,LD50,"4,164 mg/kg bw",adverse effect observed, "[[(phosphonomethyl)imino]bis[ethane-2,1-diylnitrilobis(methylene)]]tetrakisphosphonic acid",15827-60-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6883b38-dae5-4d0a-b45a-10e75e435cf7/documents/7b645297-fdfb-4941-9bc1-cccd1edc033f_7b646454-bca3-48b9-a3c3-7489c99df8c6.html,,dermal,LD50,"> 4,605 mg/kg bw",no adverse effect observed, Bis(2-ethylhexyl) adipate,103-23-1,"28-day, oral, gavage, rat: NOAEL = 200mg/kg (Miyata 2006, according to draft of the enhanced OECD 407 guideline)2-year, oral, diet, rat: NOAEL = 600mg/kg (NTP, 1982, comparable to OECD 451) Within this study, additional range finding studies in rats and mice were performed (2-weeks, 90-days) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/27427528-4587-4a68-a7de-ce70f1833d62/documents/IUC5-708b1d49-a002-48b3-9607-9f3d8605b1a5_7d6f1e3d-e034-4589-95a0-d02ebed0ef31.html,,,,,, Bis(2-ethylhexyl) adipate,103-23-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/27427528-4587-4a68-a7de-ce70f1833d62/documents/IUC5-708b1d49-a002-48b3-9607-9f3d8605b1a5_7d6f1e3d-e034-4589-95a0-d02ebed0ef31.html,Chronic toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat Bis(2-ethylhexyl) adipate,103-23-1," Acute oral toxicity: NTP (1982, comparable to OECD 401): rats: LD50 > 20000 mg/kg mice: LD50 > 20000mg/kg (females), app. 15000mg/kg (males) BASF (1955, comparable to OECD 401) rats: LD50 app. 19100mg/kg (converted from 20.7ml/kg) 1 rabbit and 1 cat: no mortality at app. 4600mg/kg Smyth (1951) LD50: 9100 mg/kg bw Acute inhalation toxicity BASF (1998, OECD 403, GLP) rats: LC50 >5.7mg/L Acute dermal toxicity Smyth (1951) rabbits: LD50=16300 ml/kg bw (~15 076 mg/kg bw) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27427528-4587-4a68-a7de-ce70f1833d62/documents/IUC5-3ce72462-7e59-4154-9ffc-26b9df3ffecd_7d6f1e3d-e034-4589-95a0-d02ebed0ef31.html,,,,,, Bis(2-ethylhexyl) adipate,103-23-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27427528-4587-4a68-a7de-ce70f1833d62/documents/IUC5-3ce72462-7e59-4154-9ffc-26b9df3ffecd_7d6f1e3d-e034-4589-95a0-d02ebed0ef31.html,,oral,LD50,"20,000 mg/kg bw",no adverse effect observed, Bis(2-ethylhexyl) adipate,103-23-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27427528-4587-4a68-a7de-ce70f1833d62/documents/IUC5-3ce72462-7e59-4154-9ffc-26b9df3ffecd_7d6f1e3d-e034-4589-95a0-d02ebed0ef31.html,,dermal,LD50,"15,076 mg/kg bw",adverse effect observed, Bis(2-ethylhexyl) adipate,103-23-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27427528-4587-4a68-a7de-ce70f1833d62/documents/IUC5-3ce72462-7e59-4154-9ffc-26b9df3ffecd_7d6f1e3d-e034-4589-95a0-d02ebed0ef31.html,,inhalation,discriminating conc.,"5,700 mg/m3",no adverse effect observed, Bis(2-ethylhexyl) carbonate,14858-73-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e80674dc-ee4d-4c73-99fe-b6a47aab41cc/documents/1900da24-a6fa-410b-bdc9-f45f25c8abca_5fc26289-6bec-474a-a278-94b09e54e190.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,275 mg/kg bw/day,,rat Bis(2-ethylhexyl) carbonate,14858-73-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e80674dc-ee4d-4c73-99fe-b6a47aab41cc/documents/0286661a-12fd-4f17-9325-2a9686ed2d05_5fc26289-6bec-474a-a278-94b09e54e190.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Bis(2-ethylhexyl) carbonate,14858-73-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e80674dc-ee4d-4c73-99fe-b6a47aab41cc/documents/0286661a-12fd-4f17-9325-2a9686ed2d05_5fc26289-6bec-474a-a278-94b09e54e190.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Bis(2-ethylhexyl) fumarate,141-02-6," A 90-day toxicity study has been performed instead of the 28-day toxicity study. No systemic effects have been reported. No toxicologically significant changes were noted in any of the other parameters investigated in this study (i.e. clinical appearance, functional observations, ophthalmoscopy, body weight, food consumption, clinical laboratory investigations and macroscopic examination). No adverse effects were observed in the reproductive organs examined in this study. Spermatogenic staging profiles were normal for all males examined. NOAEL (rat, 90 day, oral) > 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0a80771-4375-4f9b-9c04-757a944dd72d/documents/30d68735-9467-46f7-932c-a7016d3e3fbe_09bcd535-006a-47ce-8139-ecae732b76cf.html,,,,,, Bis(2-ethylhexyl) fumarate,141-02-6," Acute oral toxicity, rats: LD50 = 29.2 g per kg body weight Acute dermal toxicity, rabbits. LD50 > 20 mL per kg body weight which is equal to 18840 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0a80771-4375-4f9b-9c04-757a944dd72d/documents/21c8081f-d309-4eb7-a3d8-c6394a97266d_09bcd535-006a-47ce-8139-ecae732b76cf.html,,,,,, Bis(2-ethylhexyl) fumarate,141-02-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0a80771-4375-4f9b-9c04-757a944dd72d/documents/21c8081f-d309-4eb7-a3d8-c6394a97266d_09bcd535-006a-47ce-8139-ecae732b76cf.html,,oral,LD50,"29,200 mg/kg bw",, Bis(2-ethylhexyl) fumarate,141-02-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0a80771-4375-4f9b-9c04-757a944dd72d/documents/21c8081f-d309-4eb7-a3d8-c6394a97266d_09bcd535-006a-47ce-8139-ecae732b76cf.html,,dermal,LD50,"18,840 mg/kg bw",, Bis(2-ethylhexyl) maleate,142-16-5," In the absence of significant data with dioctyl maleate itself, a weight of evidence approach was applied. Because of the chemical similarities of dioctyl maleate to n-butyl maleate and dibutyl maleate, the available repeated-dose toxicity data should be sufficient for read-across assessment. Animal studies showed that the main target organs were the kidneys. A 90-day oral study in rats with dibutyl maleate revealed the most severe systemic effects (CPN). Therefore, the LOAEL of 30 mg/kg/day was selected for the derivation of the DNEL for long systemic effects. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8725e747-d9b0-4f87-8ee1-9850ce76ae25/documents/IUC5-341d743e-f14e-4899-8ad4-539ad4a96020_d794f3a6-26d4-49a8-b5c9-307e92b33b7f.html,,,,,, Bis(2-ethylhexyl) maleate,142-16-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8725e747-d9b0-4f87-8ee1-9850ce76ae25/documents/IUC5-341d743e-f14e-4899-8ad4-539ad4a96020_d794f3a6-26d4-49a8-b5c9-307e92b33b7f.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,30 mg/kg bw/day,,rat Bis(2-ethylhexyl) maleate,142-16-5," Acute toxicity testing by oral, dermal and inhalation exposure demonstrated no evidence of toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8725e747-d9b0-4f87-8ee1-9850ce76ae25/documents/IUC5-d042b591-1d75-4d0f-862f-4f31198dc689_d794f3a6-26d4-49a8-b5c9-307e92b33b7f.html,,,,,, Bis(2-ethylhexyl) maleate,142-16-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8725e747-d9b0-4f87-8ee1-9850ce76ae25/documents/IUC5-d042b591-1d75-4d0f-862f-4f31198dc689_d794f3a6-26d4-49a8-b5c9-307e92b33b7f.html,,oral,LD50,"2,000 mg/kg bw",, Bis(2-ethylhexyl) maleate,142-16-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8725e747-d9b0-4f87-8ee1-9850ce76ae25/documents/IUC5-d042b591-1d75-4d0f-862f-4f31198dc689_d794f3a6-26d4-49a8-b5c9-307e92b33b7f.html,,dermal,LD50,"14,000 mg/kg bw",, Bis(2-ethylhexyl) maleate,142-16-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8725e747-d9b0-4f87-8ee1-9850ce76ae25/documents/IUC5-d042b591-1d75-4d0f-862f-4f31198dc689_d794f3a6-26d4-49a8-b5c9-307e92b33b7f.html,,inhalation,LC50,"5,000 mg/m3",, Bis(2-ethylhexyl) phthalate,117-81-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f1917da-0781-4b4c-bf29-759626d96047/documents/b2611e5c-c071-422d-b4ed-4b88dc63042e_19f56294-d09c-44ac-b824-60c31b09d317.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,29 mg/kg bw/day,,rat Bis(2-ethylhexyl) phthalate,117-81-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f1917da-0781-4b4c-bf29-759626d96047/documents/b2611e5c-c071-422d-b4ed-4b88dc63042e_19f56294-d09c-44ac-b824-60c31b09d317.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,50 mg/m3,, Bis(2-ethylhexyl) phthalate,117-81-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f1917da-0781-4b4c-bf29-759626d96047/documents/b2611e5c-c071-422d-b4ed-4b88dc63042e_19f56294-d09c-44ac-b824-60c31b09d317.html,Repeated dose toxicity – local effects,inhalation,NOAEC,50 mg/m3,adverse effect observed, Bis(2-ethylhexyl) phthalate,117-81-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f1917da-0781-4b4c-bf29-759626d96047/documents/07f9ae2f-5ba1-4e1c-b23e-08f7d28090df_19f56294-d09c-44ac-b824-60c31b09d317.html,,oral,discriminating dose,"20,000 mg/kg bw",no adverse effect observed, Bis(2-ethylhexyl) phthalate,117-81-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f1917da-0781-4b4c-bf29-759626d96047/documents/07f9ae2f-5ba1-4e1c-b23e-08f7d28090df_19f56294-d09c-44ac-b824-60c31b09d317.html,,dermal,LD50,"19,800 mg/kg bw",adverse effect observed, Bis(2-ethylhexyl) phthalate,117-81-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f1917da-0781-4b4c-bf29-759626d96047/documents/07f9ae2f-5ba1-4e1c-b23e-08f7d28090df_19f56294-d09c-44ac-b824-60c31b09d317.html,,inhalation,discriminating conc.,"10,620 mg/m3",adverse effect observed, Bis(2-ethylhexyl) sebacate,122-62-3,"In conclusion, no human hazard for systemic toxicity after repeated oral, dermal, or inhalation exposure was identified for the PFAE linear category members. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07172d3f-a840-4daa-9357-5cd46eb67574/documents/IUC5-aa8e4203-6a2c-4f6d-8961-1596a6486f1b_080bca3b-b90d-4bdf-b82d-94b7f6cd2f84.html,,,,,, Bis(2-ethylhexyl) sebacate,122-62-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07172d3f-a840-4daa-9357-5cd46eb67574/documents/IUC5-aa8e4203-6a2c-4f6d-8961-1596a6486f1b_080bca3b-b90d-4bdf-b82d-94b7f6cd2f84.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Bis(2-ethylhexyl) sebacate,122-62-3,All available acute oral toxicity studies within this category resulted in acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.7 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07172d3f-a840-4daa-9357-5cd46eb67574/documents/IUC5-c25534be-a32d-45f9-8e64-4b2e303fb506_080bca3b-b90d-4bdf-b82d-94b7f6cd2f84.html,,,,,, Docusate sodium,577-11-7," Repeated dose oral toxicity was tested in various species, including rats, dogs, rabbits and monkeys. The NOAEL of 1000 mg/kg bw/day obtained in the key subchronic dietary toxicity study in rats was confirmed to be consistent with data from docusate sodium in supporting studies in rats; other data from other species were of limited reliability and relevance and therefore not taken into account. Repeated dose inhalation toxicity was tested in rats by aerosol of a product containing an effective Docusate sodium concentration of 0.21%. The concentration of exposure was 4.2 mg/m3 , exposed 4 hours a day, 5 days a week, for 13 weeks. The study was not considered relevant as findings were minor, no NOAEC was defined wiht only one dose tested, and further details were not available in literature. Literature data on repeated dermal testing in experimental animals were found. No NOAEL values were defined, and further details were not available in literature. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83c6079d-1324-400b-9df3-81b3867853af/documents/b385200e-a855-425f-896d-282f60abfdb1_278e6592-aee3-4c5b-b749-c64a2c52b386.html,,,,,, Docusate sodium,577-11-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83c6079d-1324-400b-9df3-81b3867853af/documents/b385200e-a855-425f-896d-282f60abfdb1_278e6592-aee3-4c5b-b749-c64a2c52b386.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Docusate sodium,577-11-7," Both oral and dermal acute toxicity were tested in various studies with docusate sodium and formulations, demonstrating that LD50 values were above the limit dose of 2000 mg active ingredient/kg bw. LD50 values are  approximately 3000 mg/kg bw for acute oral toxicity in rats and 2525 mg/kg bw for acute dermal toxicity in rabbits. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83c6079d-1324-400b-9df3-81b3867853af/documents/aa928005-6ffa-4361-b152-b0d24224dfa3_278e6592-aee3-4c5b-b749-c64a2c52b386.html,,,,,, Docusate sodium,577-11-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83c6079d-1324-400b-9df3-81b3867853af/documents/aa928005-6ffa-4361-b152-b0d24224dfa3_278e6592-aee3-4c5b-b749-c64a2c52b386.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, Docusate sodium,577-11-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83c6079d-1324-400b-9df3-81b3867853af/documents/aa928005-6ffa-4361-b152-b0d24224dfa3_278e6592-aee3-4c5b-b749-c64a2c52b386.html,,dermal,LD50,"2,525 mg/kg bw",no adverse effect observed, Docusate sodium,577-11-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83c6079d-1324-400b-9df3-81b3867853af/documents/aa928005-6ffa-4361-b152-b0d24224dfa3_278e6592-aee3-4c5b-b749-c64a2c52b386.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, Bis(2-ethylhexyl) succinate,2915-57-3,"Oral (rat): NOEL = 551mg/kg/day (male), 630 mg/kg bw/day (female) 90 days, National Toxicology Program 1982 Oral (mouse): NOAEL = not determoined, but figure of 2000 mg/kg bw/day used for DNEL estimate (based on significant reduced weight gain that may have been taste aversion), 90 days mouse dietary male/female, National Toxicology Program 1982   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9afd52ae-0867-465c-9839-d8c70e0e95cb/documents/0c1fd6a2-77db-4be2-b6a2-a452b0633408_a8ca68e0-9ad9-41de-9101-49a08486a2d4.html,,,,,, Bis(2-ethylhexyl) succinate,2915-57-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9afd52ae-0867-465c-9839-d8c70e0e95cb/documents/0c1fd6a2-77db-4be2-b6a2-a452b0633408_a8ca68e0-9ad9-41de-9101-49a08486a2d4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,550 mg/kg bw/day,,rat Bis(2-ethylhexyl) succinate,2915-57-3,Studies were conducted according to recognised testing guidelines and with GLP certification.   ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9afd52ae-0867-465c-9839-d8c70e0e95cb/documents/778cccfb-8b67-4502-8105-9615df69042d_a8ca68e0-9ad9-41de-9101-49a08486a2d4.html,,,,,, Bis(2-ethylhexyl) terephthalate,6422-86-2," The overall NOEL for the 90-day feeding study was 0.5% in the diet (equivalent to 277 and 309 mg/kg bw/day for males and females, respectively). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0bb1dc57-e672-49a8-b940-3e4c0327eba7/documents/IUC5-3ba3ca67-2a47-4f87-86ec-89cbe1c72f81_6d630186-3a59-4cfa-8ff3-2621fdebbdd7.html,,,,,, Bis(2-ethylhexyl) terephthalate,6422-86-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0bb1dc57-e672-49a8-b940-3e4c0327eba7/documents/IUC5-3ba3ca67-2a47-4f87-86ec-89cbe1c72f81_6d630186-3a59-4cfa-8ff3-2621fdebbdd7.html,Short-term repeated dose toxicity – systemic effects,dermal,,813 mg/kg bw/day,,guinea pig Bis(2-ethylhexyl) terephthalate,6422-86-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0bb1dc57-e672-49a8-b940-3e4c0327eba7/documents/IUC5-3ba3ca67-2a47-4f87-86ec-89cbe1c72f81_6d630186-3a59-4cfa-8ff3-2621fdebbdd7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,277 mg/kg bw/day,,rat Bis(2-ethylhexyl) terephthalate,6422-86-2," The single dose oral LD50 in rats was greater than 5000 mg/kg bw. The dermal LD50 in guinea pigs was > 20.0 mL/kg bw (equivalent to 19,680 mg/kg bw). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0bb1dc57-e672-49a8-b940-3e4c0327eba7/documents/IUC5-8a6d7c00-a85e-4add-88dd-9c33d3f6bac6_6d630186-3a59-4cfa-8ff3-2621fdebbdd7.html,,,,,, Bis(2-ethylhexyl) terephthalate,6422-86-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0bb1dc57-e672-49a8-b940-3e4c0327eba7/documents/IUC5-8a6d7c00-a85e-4add-88dd-9c33d3f6bac6_6d630186-3a59-4cfa-8ff3-2621fdebbdd7.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Bis(2-ethylhexyl) terephthalate,6422-86-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0bb1dc57-e672-49a8-b940-3e4c0327eba7/documents/IUC5-8a6d7c00-a85e-4add-88dd-9c33d3f6bac6_6d630186-3a59-4cfa-8ff3-2621fdebbdd7.html,,dermal,LD50,"19,680 mg/kg bw",no adverse effect observed, Bis(2-ethylhexyl)amine,106-20-7,"Combined repeated dose and reproduction / developmental screening study, rat, oral, OECD TG 422, under GLP, NOAEL = 75 mg/kg bw/day, K1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bb42458-3b08-45ad-8a59-b22c7d9467d2/documents/IUC5-c83f37f7-060e-4675-8f0a-3d2d490f2a81_5719f4a6-1243-4d80-b23d-09a06dc7dac6.html,,,,,, Bis(2-ethylhexyl)amine,106-20-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bb42458-3b08-45ad-8a59-b22c7d9467d2/documents/IUC5-c83f37f7-060e-4675-8f0a-3d2d490f2a81_5719f4a6-1243-4d80-b23d-09a06dc7dac6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat Bis(2-ethylhexyl)amine,106-20-7,"Oral: rat, similar to OECD TG 401, non-GLP, LD50 = 1008 mg/kg bw, K2 Dermal: rabbit, LD50 = 956 mg/kg bw, K4 Inhalation: rat, similar to OECD TG 403, under GLP, LC50 = 910 mg/m3, K1 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bb42458-3b08-45ad-8a59-b22c7d9467d2/documents/IUC5-b52073bf-c770-4ba8-bf1c-f41d3c55857b_5719f4a6-1243-4d80-b23d-09a06dc7dac6.html,,,,,, Bis(2-ethylhexyl)amine,106-20-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bb42458-3b08-45ad-8a59-b22c7d9467d2/documents/IUC5-b52073bf-c770-4ba8-bf1c-f41d3c55857b_5719f4a6-1243-4d80-b23d-09a06dc7dac6.html,,oral,LD50,"1,008 mg/kg bw",adverse effect observed, Bis(2-ethylhexyl)amine,106-20-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bb42458-3b08-45ad-8a59-b22c7d9467d2/documents/IUC5-b52073bf-c770-4ba8-bf1c-f41d3c55857b_5719f4a6-1243-4d80-b23d-09a06dc7dac6.html,,dermal,LD50,956 mg/kg bw,adverse effect observed, Bis(2-ethylhexyl)amine,106-20-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bb42458-3b08-45ad-8a59-b22c7d9467d2/documents/IUC5-b52073bf-c770-4ba8-bf1c-f41d3c55857b_5719f4a6-1243-4d80-b23d-09a06dc7dac6.html,,inhalation,LC50,910 mg/m3,adverse effect observed, "2,4-Pyridinedicarboxylic acid, diethyl ester",41438-38-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): reliability 1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72bb8678-c949-4332-baca-8db7017b1d2b/documents/IUC5-6121a067-2ae3-4a9b-8e8e-eac8650332e0_38648041-b2a0-474f-9497-6dbb44a0ebc6.html,,,,,, "2,4-Pyridinedicarboxylic acid, diethyl ester",41438-38-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72bb8678-c949-4332-baca-8db7017b1d2b/documents/IUC5-6121a067-2ae3-4a9b-8e8e-eac8650332e0_38648041-b2a0-474f-9497-6dbb44a0ebc6.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,750 mg/kg bw/day,,rat "2,4-Pyridinedicarboxylic acid, diethyl ester",41438-38-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliability 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): reliability 2 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72bb8678-c949-4332-baca-8db7017b1d2b/documents/IUC5-2af12d1e-d308-480b-bb41-50810770a181_38648041-b2a0-474f-9497-6dbb44a0ebc6.html,,,,,, Oxybispropanediol,59113-36-9,Repeated dose inhalation toxicity is read-across from glycerol: a 14-day and 90-day study available. And a 2-year oral repeated dose toxicity study is available with glycerol. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9048c226-35cf-49d3-979f-07dab18fe628/documents/IUC5-e469f5bb-5662-4393-9461-9f97e0ba31e1_981f509d-2a5c-4b33-bb9b-7ae8983aa2a8.html,,,,,, Oxybispropanediol,59113-36-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9048c226-35cf-49d3-979f-07dab18fe628/documents/IUC5-e469f5bb-5662-4393-9461-9f97e0ba31e1_981f509d-2a5c-4b33-bb9b-7ae8983aa2a8.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,662 mg/m3,,rat Oxybispropanediol,59113-36-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9048c226-35cf-49d3-979f-07dab18fe628/documents/IUC5-e469f5bb-5662-4393-9461-9f97e0ba31e1_981f509d-2a5c-4b33-bb9b-7ae8983aa2a8.html,Chronic toxicity – systemic effects,oral,NOAEL,"10,000 mg/kg bw/day",,rat Oxybispropanediol,59113-36-9,"A reliable oral toxicity study in rats (according to OECD 401) with diglycerol has been performed showing an LD50 > 5000 mg/kg bw. A second oral toxicity study in rats (according to OECD 401) with cyclic diglycerol also showed an LD50 > 2000 mg/kg bw. No studies on acute exposure via inhalation or skin are available. A dermal toxicity study performed with glycerol was performed, showing an LD50>2000 mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9048c226-35cf-49d3-979f-07dab18fe628/documents/IUC5-278ffc66-9f72-41b5-bc6d-929a8fb0fa8f_981f509d-2a5c-4b33-bb9b-7ae8983aa2a8.html,,,,,, Oxybispropanediol,59113-36-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9048c226-35cf-49d3-979f-07dab18fe628/documents/IUC5-278ffc66-9f72-41b5-bc6d-929a8fb0fa8f_981f509d-2a5c-4b33-bb9b-7ae8983aa2a8.html,,oral,LD50,"5,000 mg/kg bw",, Oxybispropanediol,59113-36-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9048c226-35cf-49d3-979f-07dab18fe628/documents/IUC5-278ffc66-9f72-41b5-bc6d-929a8fb0fa8f_981f509d-2a5c-4b33-bb9b-7ae8983aa2a8.html,,dermal,LD50,"18,700 mg/kg bw",, "Reaction mass of 3-[3-(2,3-dihydroxypropoxy)-2-hydroxypropoxy]propane-1,2-diol and 3-(2,3-dihydroxypropoxy)propane-1,2-diol and 3-[3-[3-(2,3-dihydroxypropoxy)-2-hydroxypropoxy]-2-hydroxypropoxy]propane-1,2-diol",25618-55-7,"All repeated dose toxicity data is based on the read across substances glycerol and Polyglycerol Polyricinoleate (PGPR). See ""Read across report"" attached to the dossier. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b1ed8b5-d1c7-4e91-adf1-89fcd3f226f7/documents/IUC5-b6c8d819-db5a-4939-905e-e25f079ea0cb_e156bb25-a5d2-430d-9120-9113422458a0.html,,,,,, "Reaction mass of 3-[3-(2,3-dihydroxypropoxy)-2-hydroxypropoxy]propane-1,2-diol and 3-(2,3-dihydroxypropoxy)propane-1,2-diol and 3-[3-[3-(2,3-dihydroxypropoxy)-2-hydroxypropoxy]-2-hydroxypropoxy]propane-1,2-diol",25618-55-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b1ed8b5-d1c7-4e91-adf1-89fcd3f226f7/documents/IUC5-b6c8d819-db5a-4939-905e-e25f079ea0cb_e156bb25-a5d2-430d-9120-9113422458a0.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,660 mg/m3,,rat "Reaction mass of 3-[3-(2,3-dihydroxypropoxy)-2-hydroxypropoxy]propane-1,2-diol and 3-(2,3-dihydroxypropoxy)propane-1,2-diol and 3-[3-[3-(2,3-dihydroxypropoxy)-2-hydroxypropoxy]-2-hydroxypropoxy]propane-1,2-diol",25618-55-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b1ed8b5-d1c7-4e91-adf1-89fcd3f226f7/documents/IUC5-b6c8d819-db5a-4939-905e-e25f079ea0cb_e156bb25-a5d2-430d-9120-9113422458a0.html,Chronic toxicity – systemic effects,oral,NOAEL,"10,000 mg/kg bw/day",,rat "Reaction mass of 3-[3-(2,3-dihydroxypropoxy)-2-hydroxypropoxy]propane-1,2-diol and 3-(2,3-dihydroxypropoxy)propane-1,2-diol and 3-[3-[3-(2,3-dihydroxypropoxy)-2-hydroxypropoxy]-2-hydroxypropoxy]propane-1,2-diol",25618-55-7,"Two acute oral toxicity studies on rats with Polyglycerol-3 are available.An acute dermal toxicity test is available with the read-across substance glycerol (see ""Read across report"" attached to the dossier). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b1ed8b5-d1c7-4e91-adf1-89fcd3f226f7/documents/IUC5-cec9b155-6f9a-4b59-a607-97233220b1f1_e156bb25-a5d2-430d-9120-9113422458a0.html,,,,,, Dihexyl adipate,110-33-8,"In conclusion, no human hazard for systemic toxicity after repeated oral, dermal, or inhalation exposure was identified for the PFAE linear category members. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0079d14b-0b4f-42d8-a0db-147c27c3e9a5/documents/41f4b853-475a-45fa-be4c-744c2d75e1e0_d5669b6f-260e-470b-b36c-da8deffe3f08.html,,,,,, Dihexyl adipate,110-33-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0079d14b-0b4f-42d8-a0db-147c27c3e9a5/documents/41f4b853-475a-45fa-be4c-744c2d75e1e0_d5669b6f-260e-470b-b36c-da8deffe3f08.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Dihexyl adipate,110-33-8,All available acute oral toxicity studies within this category resulted in acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.7 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0079d14b-0b4f-42d8-a0db-147c27c3e9a5/documents/01223145-fa6a-4dfd-856f-9704ca7345bc_d5669b6f-260e-470b-b36c-da8deffe3f08.html,,,,,, Dihexyl fumarate,19139-31-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7307f2be-8d9f-4e01-b50e-8aee13cd9c1b/documents/2ff11353-911f-4567-bab0-72641c337c4f_da30e5f1-486e-4b5a-9d02-c54212113142.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dihexyl fumarate,19139-31-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7307f2be-8d9f-4e01-b50e-8aee13cd9c1b/documents/14cc1aeb-5756-4690-b695-f411a2292680_da30e5f1-486e-4b5a-9d02-c54212113142.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Dihexyl fumarate,19139-31-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7307f2be-8d9f-4e01-b50e-8aee13cd9c1b/documents/14cc1aeb-5756-4690-b695-f411a2292680_da30e5f1-486e-4b5a-9d02-c54212113142.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "1,2,3,5,6,7-hexahydro-1,1,2,3,3-pentamethyl-4H-inden-4-one",33704-61-9,"Under the conditions of the test (OECD 408, GLP), the NOAEL was determined to be 10 mg/kg bw/day, based on increased adverse clinical observations, decreased pH and increased ketones in the urine of female rats, increased kidney weights, increased liver weights for female rats only and increased incidence and/or severity of histological changes in the kidney at the three highest doses. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04af9d25-4e4a-43ca-a6c1-fd1c515e8e48/documents/IUC5-abd34a66-a57d-4051-af45-9d239cd84568_966d0133-001b-4e3f-8760-cb7aa07202a7.html,,,,,, "1,2,3,5,6,7-hexahydro-1,1,2,3,3-pentamethyl-4H-inden-4-one",33704-61-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04af9d25-4e4a-43ca-a6c1-fd1c515e8e48/documents/IUC5-abd34a66-a57d-4051-af45-9d239cd84568_966d0133-001b-4e3f-8760-cb7aa07202a7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "1,2,3,5,6,7-hexahydro-1,1,2,3,3-pentamethyl-4H-inden-4-one",33704-61-9,- Acute oral toxicity: LD50 is 2685 mg/kg bw (female) (method similar to OECD TG 401)- Acute inhalation toxicity: LD50 is 6981 mg/m3 (route-to-route extrapolation from acute oral toxicity study)- Acute dermal toxicity: LD50 is 2685 mg/kg bw (route-to-route extrapolation from acute oral toxicity study) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04af9d25-4e4a-43ca-a6c1-fd1c515e8e48/documents/IUC5-ab7e5f69-03f3-42a2-8097-99c0e395a6a9_966d0133-001b-4e3f-8760-cb7aa07202a7.html,,,,,, "1,2,3,5,6,7-hexahydro-1,1,2,3,3-pentamethyl-4H-inden-4-one",33704-61-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04af9d25-4e4a-43ca-a6c1-fd1c515e8e48/documents/IUC5-ab7e5f69-03f3-42a2-8097-99c0e395a6a9_966d0133-001b-4e3f-8760-cb7aa07202a7.html,,oral,LD50,"2,685 mg/kg bw",no adverse effect observed, "1,2,3,5,6,7-hexahydro-1,1,2,3,3-pentamethyl-4H-inden-4-one",33704-61-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04af9d25-4e4a-43ca-a6c1-fd1c515e8e48/documents/IUC5-ab7e5f69-03f3-42a2-8097-99c0e395a6a9_966d0133-001b-4e3f-8760-cb7aa07202a7.html,,dermal,LD50,"2,685 mg/kg bw",no adverse effect observed, "1,2,3,5,6,7-hexahydro-1,1,2,3,3-pentamethyl-4H-inden-4-one",33704-61-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04af9d25-4e4a-43ca-a6c1-fd1c515e8e48/documents/IUC5-ab7e5f69-03f3-42a2-8097-99c0e395a6a9_966d0133-001b-4e3f-8760-cb7aa07202a7.html,,inhalation,LC50,"6,981 mg/m3",no adverse effect observed, p-propylanisole,104-45-0, The available data include two acute oral toxicity studies in rats. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d7bc83a-a711-4cd0-ab5e-9f73e0998fdc/documents/90c0730c-f9b3-4639-b69d-fe9568c78f09_46b1ec5d-2b09-4970-928f-53a2f33d4cc2.html,,,,,, p-propylanisole,104-45-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d7bc83a-a711-4cd0-ab5e-9f73e0998fdc/documents/90c0730c-f9b3-4639-b69d-fe9568c78f09_46b1ec5d-2b09-4970-928f-53a2f33d4cc2.html,,oral,LD50,"4,400 mg/kg bw",no adverse effect observed, "3,7-dimethyloctan-1-ol",106-21-8,"Repeated dose toxicity:- oral (OECD 408, GLP, rat): NOAEL = 150 mg/kg bw/d (BASF 1996; 51C0279/94026; read across: 2-propyl-1-heptanol, CAS 10042-59-8 ) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/642ca92d-9d6a-488b-89d3-4f9600a3ff2b/documents/IUC5-d71f73bd-1e26-454e-a48e-35f56cc5a1fb_f2c1acca-ad38-4fdf-b2f7-600fd7aa4a79.html,,,,,, "3,7-dimethyloctan-1-ol",106-21-8,Acute oral toxicity: non-toxic after single oral administration (Shelanski 1973)Acute dermal toxicity: of low acute toxicity after single dermal administration (WoE). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/642ca92d-9d6a-488b-89d3-4f9600a3ff2b/documents/IUC5-dd4dde4d-2c93-4cc4-b5a8-982a65cccb90_f2c1acca-ad38-4fdf-b2f7-600fd7aa4a79.html,,,,,, "3,7-dimethyl-1-octyl acetate",20780-49-8," Repeated dose toxicity: Oral No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg body weight, when Sprague Dawley male and female rats were treated with the given test chemical via oral route, over a period of 90 days.   Repeated dose toxicity: Inhalation A short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the given test chemical has very low vapor pressure 12.93 Pa (0.0900074 mmHg), so the potential for the generation of inhalable vapors is very low. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated inhalation toxicity was considered for waiver.   Repeated dose toxicity: Dermal A short-term toxicity study does not need to be conducted because exposure of humans via dermal in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the acute dermal toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdf33537-1103-449e-8fb7-2231c71af838/documents/157a3582-fe1f-4101-be6d-bfcb5c5c0ac8_5d2962c9-72e4-4477-b574-d0bf3a4db123.html,,,,,, "3,7-dimethyl-1-octyl acetate",20780-49-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdf33537-1103-449e-8fb7-2231c71af838/documents/157a3582-fe1f-4101-be6d-bfcb5c5c0ac8_5d2962c9-72e4-4477-b574-d0bf3a4db123.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,7-dimethyl-1-octyl acetate",20780-49-8," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The LD50 value is >5000 mg/kg bw. The value concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to low vapour pressure of the test chemical, which is reported to be 0.097 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rabbits for the given test chemical. The LD50 value is 5000 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdf33537-1103-449e-8fb7-2231c71af838/documents/ed4e9875-4965-4335-a161-9862b80335ab_5d2962c9-72e4-4477-b574-d0bf3a4db123.html,,,,,, "3,7-dimethyl-1-octyl acetate",20780-49-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdf33537-1103-449e-8fb7-2231c71af838/documents/ed4e9875-4965-4335-a161-9862b80335ab_5d2962c9-72e4-4477-b574-d0bf3a4db123.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,7-dimethyl-1-octyl acetate",20780-49-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdf33537-1103-449e-8fb7-2231c71af838/documents/ed4e9875-4965-4335-a161-9862b80335ab_5d2962c9-72e4-4477-b574-d0bf3a4db123.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-methoxy-4-propylphenol,2785-87-7," Repeated dose toxicity oral: systemic NOAEL = 151.84 mg/kg bw/day in female mice (similar to OECD 408, read-across to trans-isoeugenol K, rel. 2) Repeated dose toxicity oral: local NOAEL = 76 mg/kg bw/day in male rats (similar to OECD 408, read-across to trans-isoeugenol, K, rel. 2) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ceb5b03-5763-42bc-a2c6-5f9f9401a439/documents/cd7a811f-4841-4dbe-a73d-8b0799163362_12b01165-c63c-4716-9ec0-338073843d53.html,,,,,, 2-methoxy-4-propylphenol,2785-87-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ceb5b03-5763-42bc-a2c6-5f9f9401a439/documents/cd7a811f-4841-4dbe-a73d-8b0799163362_12b01165-c63c-4716-9ec0-338073843d53.html,Chronic toxicity – systemic effects,oral,NOAEL,151.84 mg/kg bw/day,,rat 2-methoxy-4-propylphenol,2785-87-7,"Acute toxicity: oral: LD50 = 2600 mg/kg bw (similar to OECD 401 in rats, K, rel.2);Acute toxicity: dermal: LD50 > 2000 mg/kg bw (OECD 402, K, rel. 1);Acute toxicity: inhalation: waiver. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ceb5b03-5763-42bc-a2c6-5f9f9401a439/documents/3b88efa8-baec-4a51-97b5-142da9031515_12b01165-c63c-4716-9ec0-338073843d53.html,,,,,, 2-methoxy-4-propylphenol,2785-87-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ceb5b03-5763-42bc-a2c6-5f9f9401a439/documents/3b88efa8-baec-4a51-97b5-142da9031515_12b01165-c63c-4716-9ec0-338073843d53.html,,oral,LD50,"2,600 mg/kg bw",adverse effect observed, 2-methoxy-4-propylphenol,2785-87-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ceb5b03-5763-42bc-a2c6-5f9f9401a439/documents/3b88efa8-baec-4a51-97b5-142da9031515_12b01165-c63c-4716-9ec0-338073843d53.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,7-dimethyl-6-octenyl 2-methylcrotonate",24717-85-9," Oral (OECD 423), rat: LD50 cut-off ≥ 5000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd063c66-db51-4efb-8694-4c26c0630496/documents/993383d0-e18f-4e67-90a4-34943256d620_b1e6c905-4509-406d-a4ff-8f72ad45d221.html,,,,,, 2-hexylcyclopent-2-enone,95-41-0, Oral LD50 is >5000 mg/kg bw Dermal LD50 is >5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9ec7ae3-1db6-4f1d-9d84-d32a9fd8b902/documents/2e95918c-a91c-412f-9f4c-b2c7a091cbf7_de87bb10-16f2-4664-a6d2-e80c96902f79.html,,,,,, 2-hexylcyclopent-2-enone,95-41-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9ec7ae3-1db6-4f1d-9d84-d32a9fd8b902/documents/2e95918c-a91c-412f-9f4c-b2c7a091cbf7_de87bb10-16f2-4664-a6d2-e80c96902f79.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, 2-hexylcyclopent-2-enone,95-41-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9ec7ae3-1db6-4f1d-9d84-d32a9fd8b902/documents/2e95918c-a91c-412f-9f4c-b2c7a091cbf7_de87bb10-16f2-4664-a6d2-e80c96902f79.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "3,7-dimethylocta-1,6-diene",2436-90-0,Oral LD50 > 5000 mg/kg bw in rats.Dermal LD50 > 5000 mg/kg bw in rats. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c2bcda8-4944-4674-ad02-2cb3a724ea27/documents/f960e5de-816e-49bb-a245-e6e3c0893fb8_a2efe7e3-5f4d-4037-88b8-f66ee2db4073.html,,,,,, "3,7-dimethylocta-1,6-diene",2436-90-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c2bcda8-4944-4674-ad02-2cb3a724ea27/documents/f960e5de-816e-49bb-a245-e6e3c0893fb8_a2efe7e3-5f4d-4037-88b8-f66ee2db4073.html,,oral,LD50,"5,000 mg/kg bw",, "3,7-dimethylocta-1,6-diene",2436-90-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c2bcda8-4944-4674-ad02-2cb3a724ea27/documents/f960e5de-816e-49bb-a245-e6e3c0893fb8_a2efe7e3-5f4d-4037-88b8-f66ee2db4073.html,,dermal,LD50,"5,000 mg/kg bw",, "2,6-dimethyloct-7-en-2-yl acetate",53767-93-4," Dihydromyrcenyl acetate has a NOAEL >=868.7 mg/kg bw based on read across from Dihydromyrcenol, which was tested via feed in an OECD TG 422. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29ac4a0e-43cf-46c7-91ac-58384ea63e31/documents/1b54c1c4-30ef-4c4f-815e-244fcfff1288_1b5a8dc9-5aa6-40a0-a6ae-1a3825951a80.html,,,,,, "2,6-dimethyloct-7-en-2-yl acetate",53767-93-4, Acute oral toxicity: OECD TG 401: LD50 >5000 mg/kg bw Acute dermal toxicity: OECD TG 402: LD50 >5000 mg/kg bw Acute inhalation (route to route extrapolation): no adverse effect predicted ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29ac4a0e-43cf-46c7-91ac-58384ea63e31/documents/44c32214-c6b8-409b-9775-279277dde2d4_1b5a8dc9-5aa6-40a0-a6ae-1a3825951a80.html,,,,,, "2,6-dimethyloct-7-en-2-yl formate",25279-09-8, Acute oral toxicity: Key study: OECD Guideline 420. GLP study. The acute oral median lethal dose (LD50) of test item in Wistar rats was found to be greater than 2000 mg/kg body weight. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b189685-b66a-4590-af40-9152b4161b3a/documents/fe933f54-37ea-46e0-970f-7439c3a0293e_fb053b6b-cd6b-49b5-bf99-5ede4997eaca.html,,,,,, "2,6-dimethyloct-7-en-2-yl formate",25279-09-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b189685-b66a-4590-af40-9152b4161b3a/documents/fe933f54-37ea-46e0-970f-7439c3a0293e_fb053b6b-cd6b-49b5-bf99-5ede4997eaca.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3-dihydroxyacetone",96-26-4," The repeat dose toxicity of the test material was investigated in a 14-day dose-range-finding study and a 90-day subchronic study in rats using oral administration by gavage. The highest dose level of the 90-day study was 1000 mg/kg bw/day established from the 14-day dose range finding study in rats. The daily administration of the test material for 90 days did not result in any adverse effect in the rats up to the limit dose of 1000 mg/kg bw/day. Thus, a NOEL of 1000 mg/kg bw/day was established for the substance based on this 90-day oral toxicity study. All available repeat dose studies were performed according to international accepted guidelines and under GLP regulation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/81578de4-7341-44eb-b774-b10b9d8c5a95/documents/IUC5-3588f052-f2ae-4b88-9a7b-fdb8237b2931_8b03389b-0b1a-4ada-98a7-25398b717868.html,,,,,, "1,3-dihydroxyacetone",96-26-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/81578de4-7341-44eb-b774-b10b9d8c5a95/documents/IUC5-3588f052-f2ae-4b88-9a7b-fdb8237b2931_8b03389b-0b1a-4ada-98a7-25398b717868.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,3-dihydroxyacetone",96-26-4," The acute toxicty of the test item was investigated in rats after oral, inhalative and peritoneal administration. In all these tests, no mortalities have been observed up to the highest dose tested, i.e. the LD50 values exceeded 16000 mg/kg (oral), 5.114 mg/L (inhalative) and 6400 mg/kg (peritoneal), respectively. Based on this study, the test item is considered to be neither harmful nor toxic after single administration. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81578de4-7341-44eb-b774-b10b9d8c5a95/documents/IUC5-a6968735-714a-4fa5-a8a9-ba9f0f22f024_8b03389b-0b1a-4ada-98a7-25398b717868.html,,,,,, "1,3-dihydroxyacetone",96-26-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81578de4-7341-44eb-b774-b10b9d8c5a95/documents/IUC5-a6968735-714a-4fa5-a8a9-ba9f0f22f024_8b03389b-0b1a-4ada-98a7-25398b717868.html,,oral,discriminating dose,"16,000 mg/kg bw",no adverse effect observed, "1,3-dihydroxyacetone",96-26-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81578de4-7341-44eb-b774-b10b9d8c5a95/documents/IUC5-a6968735-714a-4fa5-a8a9-ba9f0f22f024_8b03389b-0b1a-4ada-98a7-25398b717868.html,,inhalation,discriminating conc.,5.114 mg/m3,no adverse effect observed, "Biphenyl-4,4'-diol",92-88-6,"Two studies are available: > A Combined repeated dose and reproduction / developmental screening study in Sprague-Dawley rats (Japanese NIHS, 2004) according to OECD 422 and using oral (gavage) administration: NOAEL= 40 mg/kg bw/day. > A 90-day repeated dose toxicity study (J. Ducroq, 2018) in Wistar rats by oral route (gavage) according to OECD 408 guideline: NOAEL = 125 mg/kg bw/day Both studies are GLP compliant.   In the OECD 422 study the administered doses were 8, 40 and 200 mg/kg bw/day. In the OECD 408 study the administered doses were 30, 125 and 500 mg/kg bw/day. The latest study, with the longest exposure (subchronic; 90 days), is regarded as the most relevant study to derive a point of departure (NOAEL) for human health risk assessment. In addition, the intervals between doses in the OECD 422 study are significatively too large. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch score = 1. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a0242f2-6984-4e2b-8f58-de7dc8bb74df/documents/IUC5-4a63f1e8-7e39-4dc2-8ad9-1db1c6c92338_a7856689-7a36-4a0a-b306-fa263c848ff5.html,,,,,, "Biphenyl-4,4'-diol",92-88-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a0242f2-6984-4e2b-8f58-de7dc8bb74df/documents/IUC5-4a63f1e8-7e39-4dc2-8ad9-1db1c6c92338_a7856689-7a36-4a0a-b306-fa263c848ff5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "Biphenyl-4,4'-diol",92-88-6, Studies of acute oral and acute dermal toxicity are available; reliable studies indicate low toxicity by these routes of administration. Limited data also indicate low acute inhalation toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a0242f2-6984-4e2b-8f58-de7dc8bb74df/documents/IUC5-2c898805-6315-4437-89f1-4cc0bcae326a_a7856689-7a36-4a0a-b306-fa263c848ff5.html,,,,,, "Biphenyl-4,4'-diol",92-88-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a0242f2-6984-4e2b-8f58-de7dc8bb74df/documents/IUC5-2c898805-6315-4437-89f1-4cc0bcae326a_a7856689-7a36-4a0a-b306-fa263c848ff5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Biphenyl-4,4'-diol",92-88-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a0242f2-6984-4e2b-8f58-de7dc8bb74df/documents/IUC5-2c898805-6315-4437-89f1-4cc0bcae326a_a7856689-7a36-4a0a-b306-fa263c848ff5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Ethanol, 2,2'-iminobis-, N-tallow alkyl derivs., N-oxides",61791-46-6," In an in vivo acute oral toxicity study according to OECD guideline 423, an LD50 of above 2000 mgkg/kg bw was determined. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ab3ec03-792e-44dc-bf89-53f9c89ed174/documents/3d5619b4-1673-4e61-a925-a539f2c1fca9_b4320530-2601-4115-b8d6-e69fcdcc23f8.html,,,,,, "2,2'-[(4-methylphenyl)imino]bisethanol",3077-12-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study (Klimisch score 1) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products and similarities in PC/ECO/TOX properties. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.6, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b5bd138-3dcc-45b3-851f-c11551ad4d85/documents/74c9e17f-8d90-4cbb-928b-c2f74a7085ff_0d235b54-f90e-41b3-9de1-d0563de5b12f.html,,,,,, "2,2'-[(4-methylphenyl)imino]bisethanol",3077-12-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b5bd138-3dcc-45b3-851f-c11551ad4d85/documents/74c9e17f-8d90-4cbb-928b-c2f74a7085ff_0d235b54-f90e-41b3-9de1-d0563de5b12f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2,2'-[(4-methylphenyl)imino]bisethanol",3077-12-1,"The available information comprises an adequate, reliable (Klimisch score 2) and consistent study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006. The available information comprises an adequate and reliable study (Klimisch score 1) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products and similarities in PC/ECO/TOX properties. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b5bd138-3dcc-45b3-851f-c11551ad4d85/documents/eef63173-1ba8-49df-a777-5b7bb71a410a_0d235b54-f90e-41b3-9de1-d0563de5b12f.html,,,,,, "2,2'-[(4-methylphenyl)imino]bisethanol",3077-12-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b5bd138-3dcc-45b3-851f-c11551ad4d85/documents/eef63173-1ba8-49df-a777-5b7bb71a410a_0d235b54-f90e-41b3-9de1-d0563de5b12f.html,,oral,LD50,959 mg/kg bw,adverse effect observed, "Sodium 1,2-diisobutoxycarbonylethanesulphonate",127-39-9,"Subacute toxicity was tested with the registered substance in Wistar rats by oral gavage at 0 (distilled water), 100, 300 and 1000 mg solid/kg bw/day in a supporting 14-day dose range finding and a key combined repeated dose/reproductive toxicity study (OECD No. 422). The NOAEL for systemic toxicity of the parental generation was 1000 mg solid/kg bw/day. Subchronic toxicity was tested with read-across substance butanedioic acid, sulfo-, 1,4-bis(1,3-dimethylbutyl) ester, sodium salt (CAS 2373-38-8) in Wistar rats by dietary administration at 0 (control diet), 1500, 3900 and 13000 ppm in a key 90-day repeated dose toxicity study (OECD No. 408). In case of High dose males, the 15000 ppm diet was used from Day 44/45 to Day 90. The NOAEL was 13000 ppm (increased to 15000 ppm in males from day 44/45), corresponding to a mean group test item intake of 870.5 mg/kg bw/day for both sexes (826 mg/kg bw/day in males and 915 mg/kg bw/day in females). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c89b877a-d837-41a8-b8f4-82d67e5ed117/documents/bc626332-97c6-4162-b74b-3a784f13f6d9_704489b5-b877-4e42-838a-38fcb89c7b6c.html,,,,,, "Sodium 1,2-diisobutoxycarbonylethanesulphonate",127-39-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c89b877a-d837-41a8-b8f4-82d67e5ed117/documents/bc626332-97c6-4162-b74b-3a784f13f6d9_704489b5-b877-4e42-838a-38fcb89c7b6c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Sodium 1,2-diisobutoxycarbonylethanesulphonate",127-39-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c89b877a-d837-41a8-b8f4-82d67e5ed117/documents/bc626332-97c6-4162-b74b-3a784f13f6d9_704489b5-b877-4e42-838a-38fcb89c7b6c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,870.5 mg/kg bw/day,,rat "Sodium 1,2-diisobutoxycarbonylethanesulphonate",127-39-9,"Oral acute toxicity testing equivalent to OECD 401 test method was performed in male rats, leading to a LD50 >2000 mg act.ingr./kg bw. Dermal acute toxicity testing equivalent to OECD 402 test method was performed in male rabbits, demonstrating a LD50 > 2000 mg act.ingr./kg bw. Acute inhalation toxicity was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulfosuccinates due to their substance properties. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c89b877a-d837-41a8-b8f4-82d67e5ed117/documents/d6552f8d-1728-424c-8607-043627045f7f_704489b5-b877-4e42-838a-38fcb89c7b6c.html,,,,,, "Sodium 1,2-diisobutoxycarbonylethanesulphonate",127-39-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c89b877a-d837-41a8-b8f4-82d67e5ed117/documents/d6552f8d-1728-424c-8607-043627045f7f_704489b5-b877-4e42-838a-38fcb89c7b6c.html,,oral,LD50,"2,772 mg/kg bw",no adverse effect observed, "Sodium 1,2-diisobutoxycarbonylethanesulphonate",127-39-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c89b877a-d837-41a8-b8f4-82d67e5ed117/documents/d6552f8d-1728-424c-8607-043627045f7f_704489b5-b877-4e42-838a-38fcb89c7b6c.html,,dermal,LD50,"2,250 mg/kg bw",no adverse effect observed, Diisodecyl adipate,27178-16-1," A subchronic oral toxicity study similar to OECD 408 was performed with the read-across substance, bis(2-ethylhexyl) adipate (CAS 103-23-1), in Fischer 344 rats and B6C3F1 mice at dose levels of 1600, 3100, 6300, 12500 and 25000 ppm for a period of 90 days (NTP, 1982). Ten animals per sex and dose received the test substance daily via diet, whereas a similar constituted control group was administered the plain diet. No signs of toxic effects and no mortality were observed in any of the animals during the study period. In mice, an adverse decrease in body weight gain compared to controls was noted starting at 3100 ppm in males and at 6300 or 25000 ppm in females, respectively. In rats, body weight gain was adversely reduced in males at 12500 and 25000 ppm. Average food consumption was not altered between treated and control groups of both genders and species. No adverse effects were noted at histopathological examination in rats and mice. Clinical chemistry and haematological parameters were not reported in this study. Based on these results, a NOAEL of 1600 ppm was derived for male B6C3F1 mice, corresponding to an actual ingested dose of 200 mg/kg bw/day. In male rats, the NOAEL was set at 6300 ppm, which was equivalent to a dose of 630 mg/kg bw/day. In female rats, the NOAEL was set at 25000 ppm, which was equivalent to a dose of 2187 mg/kg bw/day. The subchronic dermal toxicity of read-across substance, bis(tridecyl) adipate, was investigated in a 90-day study similar to OECD guideline 411 and in compliance with GLP (Lane, 1985 and 1986). The undiluted test substance was applied once daily for 5 days/week to the clipped skin of 10 Sprague Dawley rats per sex and group at dose levels of 800 and 2000 mg/kg bw/day under open conditions. A similar constituted group of animals remained untreated and served as controls. During the study, no treatment-related mortalities and no signs of systemic toxicity were observed. In general, most clinical signs involved local effects from the collars (e.g. lesions around the neck, reddish nasal discharge, chromodacryorrhea) or ocular bleedings (e.g. corneal opacities). Chronic deterioration of the skin (CDS), manifested only as flaking, was observed in males and females treated with 800 and 2000 mg/kg bw. Very slight erythema occurred in animals of both sexes at 2000 mg/kg bw/day and mostly at the beginning of the study. During the first part of the study, scabbing was observed on the backs of most animals of both treatment groups, with males being more affected than females. However, no dose-dependent relationship was apparent in either sex and scabbing was rarely seen later in the study. A slight, statistically significant decrease in body weights compared to controls was noted in treated males from Day 36 to the end of the study at 2000 mg/kg bw/day. Urinalysis revealed a dose-dependent increase in protein concentrations in females during Weeks 5, 9, and 13, and males during Weeks 5 and 9. Furthermore, the concentration of urinary ketone was slightly and dose-relatedly increased in both sexes. No toxicologically relevant changes in parameters of haematology were observed at any sampling interval. At study termination, a dose-dependent (correlation at a 95% confidence level) and statistically significant increase in clinical chemistry parameters was only seen in serum globulin concentration in females. Relative to body weight, the livers were mildly enlarged (p<0.05) in exposed rats of both sexes at 2000 mg/kg bw/day and in males at 800 mg/kg bw/day. The mean absolute kidney weight was slightly increased in males and females at 2000 mg/kg bw/day and in males at 800 mg/kg bw/day. A statistically significant increase in relative kidney weights was observed in both sexes and at both dose levels. In treated females, relative thymus weights were significantly decreased, whereas the decrease in relative thymus weight was not significant in males. Since no concomitant changes in histopathology were observed in liver, kidney and thymus, the effects on organ weights in the animals were considered to be non-adverse and adaptive responses (kidney, liver) to treatment with the test substance. Microscopic examination revealed mild hyperplasia of sebaceous glands of both sexes at 2000 mg/kg bw/day. No further treatment-related lesions were observed at gross and histopathological examination. Based on the results of this study, the systemic NOAEL for subchronic dermal toxicity in Bis(tridecyl) adipate was considered to be ≥ 2000 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3174b301-1523-4ec5-93ad-ddeaab2c44b1/documents/IUC5-0ee8eb24-34ad-4c0d-9afb-36f58d849335_39565ce5-2205-4dbe-adb4-e6ca1757b7c8.html,,,,,, Diisodecyl adipate,27178-16-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3174b301-1523-4ec5-93ad-ddeaab2c44b1/documents/IUC5-0ee8eb24-34ad-4c0d-9afb-36f58d849335_39565ce5-2205-4dbe-adb4-e6ca1757b7c8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,mouse Diisodecyl adipate,27178-16-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3174b301-1523-4ec5-93ad-ddeaab2c44b1/documents/IUC5-0ee8eb24-34ad-4c0d-9afb-36f58d849335_39565ce5-2205-4dbe-adb4-e6ca1757b7c8.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rat Diisodecyl adipate,27178-16-1," The acute oral LD50 value for read-across substance, bis(2-ethylhexyl) adipate, was determined to be ca. 19100 mg/kg bw. The acute oral LD50 value for read-across substance, diisononyl adipate, was determined to be > 5000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3174b301-1523-4ec5-93ad-ddeaab2c44b1/documents/IUC5-f72fa8cf-4a64-44cc-8aad-e53ce1db389c_39565ce5-2205-4dbe-adb4-e6ca1757b7c8.html,,,,,, Diisodecyl adipate,27178-16-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3174b301-1523-4ec5-93ad-ddeaab2c44b1/documents/IUC5-f72fa8cf-4a64-44cc-8aad-e53ce1db389c_39565ce5-2205-4dbe-adb4-e6ca1757b7c8.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Diisodecyl adipate,27178-16-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3174b301-1523-4ec5-93ad-ddeaab2c44b1/documents/IUC5-f72fa8cf-4a64-44cc-8aad-e53ce1db389c_39565ce5-2205-4dbe-adb4-e6ca1757b7c8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Diisononyl adipate,33703-08-1,"Studies with the stuctural analogue diethylhexyl adipate (DEHA):28-day, oral, gavage, rat: NOAEL = 200mg/kg (Miyata 2006, according to draft of the enhanced OECD 407 guideline)2-year, oral, diet, rat: NOAEL = 600mg/kg (NTP, 1982, comparable to OECD 451) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ae79f00-0186-45a8-90b6-6d76ecde8a9c/documents/IUC5-44ad0e58-453e-4596-9411-2471b406c030_aedd5833-30ff-422c-81de-18d909b37dcb.html,,,,,, Diisononyl adipate,33703-08-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ae79f00-0186-45a8-90b6-6d76ecde8a9c/documents/IUC5-44ad0e58-453e-4596-9411-2471b406c030_aedd5833-30ff-422c-81de-18d909b37dcb.html,Chronic toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat Diisononyl adipate,33703-08-1,"Acute oral toxicity (rat): LD50 of >5000 mg/kg bw (BASF, 1984)Acute inhaltion toxicity (rat): LC50 of > 5.7 mg/L (study performed with the structural analogue diethylhexyl adipate (DEHA)) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae79f00-0186-45a8-90b6-6d76ecde8a9c/documents/IUC5-f26ed055-7b3d-489a-a093-2800a14fd5bb_aedd5833-30ff-422c-81de-18d909b37dcb.html,,,,,, Diisononyl adipate,33703-08-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae79f00-0186-45a8-90b6-6d76ecde8a9c/documents/IUC5-f26ed055-7b3d-489a-a093-2800a14fd5bb_aedd5833-30ff-422c-81de-18d909b37dcb.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Diisononyl adipate,33703-08-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae79f00-0186-45a8-90b6-6d76ecde8a9c/documents/IUC5-f26ed055-7b3d-489a-a093-2800a14fd5bb_aedd5833-30ff-422c-81de-18d909b37dcb.html,,inhalation,discriminating conc.,"5,700 mg/m3",no adverse effect observed, Di-''isononyl'' phthalate,28553-12-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bd312bd-f1e0-4672-ad2b-2c9c3cf96158/documents/c0c61552-f2f2-48f7-9574-74862099d6d7_f0d4543d-d408-482b-8412-e96d74e734fd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,32 mg/kg bw/day,, Di-''isononyl'' phthalate,28553-12-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bd312bd-f1e0-4672-ad2b-2c9c3cf96158/documents/c0c61552-f2f2-48f7-9574-74862099d6d7_f0d4543d-d408-482b-8412-e96d74e734fd.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,, Di-''isononyl'' phthalate,28553-12-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bd312bd-f1e0-4672-ad2b-2c9c3cf96158/documents/c0c61552-f2f2-48f7-9574-74862099d6d7_f0d4543d-d408-482b-8412-e96d74e734fd.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,500 mg/m3,, Di-''isononyl'' phthalate,28553-12-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bd312bd-f1e0-4672-ad2b-2c9c3cf96158/documents/794a264e-50fd-4642-a8e4-13b904f2efa5_f0d4543d-d408-482b-8412-e96d74e734fd.html,,oral,LD50,"10,000 mg/kg bw",, Di-''isononyl'' phthalate,28553-12-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bd312bd-f1e0-4672-ad2b-2c9c3cf96158/documents/794a264e-50fd-4642-a8e4-13b904f2efa5_f0d4543d-d408-482b-8412-e96d74e734fd.html,,dermal,LD50,"3,160 mg/kg bw",, Di-''isononyl'' phthalate,28553-12-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bd312bd-f1e0-4672-ad2b-2c9c3cf96158/documents/794a264e-50fd-4642-a8e4-13b904f2efa5_f0d4543d-d408-482b-8412-e96d74e734fd.html,,inhalation,LC50,"4,400 mg/m3",, "1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich",68515-48-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65badaaa-e918-4acf-aed4-c471d1d656f1/documents/c0c61552-f2f2-48f7-9574-74862099d6d7_a61d7c00-2995-43fb-a9da-7506ff45b10c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,32 mg/kg bw/day,, "1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich",68515-48-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65badaaa-e918-4acf-aed4-c471d1d656f1/documents/c0c61552-f2f2-48f7-9574-74862099d6d7_a61d7c00-2995-43fb-a9da-7506ff45b10c.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,, "1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich",68515-48-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65badaaa-e918-4acf-aed4-c471d1d656f1/documents/c0c61552-f2f2-48f7-9574-74862099d6d7_a61d7c00-2995-43fb-a9da-7506ff45b10c.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,500 mg/m3,, "1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich",68515-48-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65badaaa-e918-4acf-aed4-c471d1d656f1/documents/794a264e-50fd-4642-a8e4-13b904f2efa5_a61d7c00-2995-43fb-a9da-7506ff45b10c.html,,oral,LD50,"10,000 mg/kg bw",, "1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich",68515-48-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65badaaa-e918-4acf-aed4-c471d1d656f1/documents/794a264e-50fd-4642-a8e4-13b904f2efa5_a61d7c00-2995-43fb-a9da-7506ff45b10c.html,,dermal,LD50,"3,160 mg/kg bw",, "1,2-Benzenedicarboxylic acid, di-C8-10-branched alkyl esters, C9-rich",68515-48-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65badaaa-e918-4acf-aed4-c471d1d656f1/documents/794a264e-50fd-4642-a8e4-13b904f2efa5_a61d7c00-2995-43fb-a9da-7506ff45b10c.html,,inhalation,LC50,"4,400 mg/m3",, "1,1'-iminodipropan-2-ol",110-97-4," In a sub-chronic oral toxicity study in rats, performed according to OECD guideline 408, NOAELs of 100 mg/kg bw/day for males and 500 mg/kg bw/day for females were established. In a sub-acute dermal toxicity study in rats, performed according to OECD guideline 410, NOAELs of 100 mg/kg bw/day (corresponding to 0.8 mg/cm2) for dermal irritation and 750 mg/kg bw/day (the highest dose tested) for systemic toxicity were established. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eaca5583-a91d-41b4-b132-0da1420b77dd/documents/IUC5-a0ae04ba-2e00-4d59-aba6-8ad3a4594f6e_500120e5-91cb-49f3-9245-10539dcfe18b.html,,,,,, "1,1'-iminodipropan-2-ol",110-97-4, Acute toxicity data indicate low toxicity: in rats the oral LD50 was > 2000 mg/kg bw; in rabbits the dermal LD50 (24h) was approximately 8000 mg/kg bw. Inhalation exposure for 8 hours to vapour saturated with DIPA failed to cause any deaths in rats (LC50 was not determined). A 3-hour inhalation exposure to 500-2069 mg/m3 DIPA (aerosol) did not cause any mortality in mice. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eaca5583-a91d-41b4-b132-0da1420b77dd/documents/IUC5-07354762-099c-4857-b1dd-849b845f0e68_500120e5-91cb-49f3-9245-10539dcfe18b.html,,,,,, Diisopropyl adipate,6938-94-9,"In conclusion, no human hazard for systemic toxicity after repeated oral, dermal, or inhalation exposure was identified for the PFAE linear category members. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/979da837-ce72-407f-ad8a-5d8a81ed1c35/documents/IUC5-aa8e4203-6a2c-4f6d-8961-1596a6486f1b_f7f063ac-8dba-4bf0-8d33-f4bf008f3a32.html,,,,,, Diisopropyl adipate,6938-94-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/979da837-ce72-407f-ad8a-5d8a81ed1c35/documents/IUC5-aa8e4203-6a2c-4f6d-8961-1596a6486f1b_f7f063ac-8dba-4bf0-8d33-f4bf008f3a32.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Diisopropyl adipate,6938-94-9,All available acute oral toxicity studies within this category resulted in acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.7 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/979da837-ce72-407f-ad8a-5d8a81ed1c35/documents/IUC5-c25534be-a32d-45f9-8e64-4b2e303fb506_f7f063ac-8dba-4bf0-8d33-f4bf008f3a32.html,,,,,, Diisopropyl sebacate,7491-02-3,"In conclusion, no human hazard for systemic toxicity after repeated oral, dermal, or inhalation exposure was identified for the PFAE linear category members. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c76855b9-6e6b-49b5-bd32-3ad7132264b7/documents/IUC5-1ae3aac3-74b8-4861-b73b-4b564f295848_ebbe70f9-a356-4372-bbbf-dc84356c30ab.html,,,,,, Diisopropyl sebacate,7491-02-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c76855b9-6e6b-49b5-bd32-3ad7132264b7/documents/IUC5-1ae3aac3-74b8-4861-b73b-4b564f295848_ebbe70f9-a356-4372-bbbf-dc84356c30ab.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Diisopropyl sebacate,7491-02-3,All available acute oral toxicity studies within this category resulted in acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.7 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c76855b9-6e6b-49b5-bd32-3ad7132264b7/documents/IUC5-8daaf6b3-0865-4e56-ab9c-715d23435612_ebbe70f9-a356-4372-bbbf-dc84356c30ab.html,,,,,, Diisopropylamine,108-18-9,"The signs of toxicity observed after subacute exposure to diisopropylamine were mainly related to its irritant/corrosive properties. The NOAE(C)Ls were 50 mg/kg/d by oral route, >=150 mg/kg/d by dermal route and less than 0.10 mg/l by inhalation. For an analogue substance, dimethylamine, no treatment-related effects were observed in rats exposed to 16 ppm (33.6 mg/m3) for 13 weeks. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cdbecf9-4da8-498c-8928-aa46c0c72059/documents/IUC5-06b20517-5f6e-4974-9b3b-40518263b010_2c156dc8-1fd1-4161-8ff3-b7a228ea7d56.html,,,,,, Diisopropylamine,108-18-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cdbecf9-4da8-498c-8928-aa46c0c72059/documents/IUC5-06b20517-5f6e-4974-9b3b-40518263b010_2c156dc8-1fd1-4161-8ff3-b7a228ea7d56.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Diisopropylamine,108-18-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cdbecf9-4da8-498c-8928-aa46c0c72059/documents/IUC5-06b20517-5f6e-4974-9b3b-40518263b010_2c156dc8-1fd1-4161-8ff3-b7a228ea7d56.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,150 mg/kg bw/day,,rat Diisopropylamine,108-18-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cdbecf9-4da8-498c-8928-aa46c0c72059/documents/IUC5-06b20517-5f6e-4974-9b3b-40518263b010_2c156dc8-1fd1-4161-8ff3-b7a228ea7d56.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,100 mg/m3,,rat Diisopropylamine,108-18-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cdbecf9-4da8-498c-8928-aa46c0c72059/documents/IUC5-06b20517-5f6e-4974-9b3b-40518263b010_2c156dc8-1fd1-4161-8ff3-b7a228ea7d56.html,Repeated dose toxicity – local effects,dermal,NOAEL,2.32 mg/cm2,no adverse effect observed,rat Diisopropylamine,108-18-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cdbecf9-4da8-498c-8928-aa46c0c72059/documents/IUC5-06b20517-5f6e-4974-9b3b-40518263b010_2c156dc8-1fd1-4161-8ff3-b7a228ea7d56.html,Repeated dose toxicity – local effects,inhalation,LOAEC,100 mg/m3,adverse effect observed,rat Diisopropylamine,108-18-9,"The acute toxicity studies in rats with Diisopropylamine (DIPA) determined an oral LD50 of 420 (277-563) mg/kg, a 4-hour inhalation LC50 of 5.35 mg/l and a dermal LD50 higher than 2000 mg/kg and lower than 5000 mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cdbecf9-4da8-498c-8928-aa46c0c72059/documents/IUC5-8b89da06-859c-4a5e-a4b4-07eab98ee521_2c156dc8-1fd1-4161-8ff3-b7a228ea7d56.html,,,,,, Diisopropylamine,108-18-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cdbecf9-4da8-498c-8928-aa46c0c72059/documents/IUC5-8b89da06-859c-4a5e-a4b4-07eab98ee521_2c156dc8-1fd1-4161-8ff3-b7a228ea7d56.html,,oral,LD50,420 mg/kg bw,adverse effect observed, Diisopropylamine,108-18-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cdbecf9-4da8-498c-8928-aa46c0c72059/documents/IUC5-8b89da06-859c-4a5e-a4b4-07eab98ee521_2c156dc8-1fd1-4161-8ff3-b7a228ea7d56.html,,dermal,discriminating dose,"2,000 mg/kg bw",adverse effect observed, Diisopropylamine,108-18-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cdbecf9-4da8-498c-8928-aa46c0c72059/documents/IUC5-8b89da06-859c-4a5e-a4b4-07eab98ee521_2c156dc8-1fd1-4161-8ff3-b7a228ea7d56.html,,inhalation,LC50,"5,350 mg/m3",adverse effect observed, Bis(16-methylheptadecyl) malate,67763-18-2,"RDT oral (OECD guideline 408), rat NOAEL = 630/2187 (males/females) mg/kg bw/day (RA from CAS 103-23-1) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a69aa64-32bb-4c91-b1d4-6fbc04e519ba/documents/IUC5-ddf0f16e-db9d-437b-ac43-fa6d49ad84a8_b8d0ea75-c112-4f81-8b20-7bc16c0b8e57.html,,,,,, Bis(16-methylheptadecyl) malate,67763-18-2,"Oral LD50 (OECD 401), mouse, LD50 >5000 mg/kg bw Dermal LD50 (OECD 402), rat, LD50 >2000 mg/kg bw (RA from CAS 149144-85-4) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a69aa64-32bb-4c91-b1d4-6fbc04e519ba/documents/IUC5-aef1fcec-4b9c-492a-8ea0-a7fa3c0a0717_b8d0ea75-c112-4f81-8b20-7bc16c0b8e57.html,,,,,, "Didodecyl 3,3'-thiodipropionate",123-28-4,"Subchronic gavage application to rats of the test substance caused signs of early or ongoing myocarditis at doses of 1000 mg/kg bw (Pharamkon No. 924102, 1993). Findings were reversible within the 4-week recovery period. The NOAEL is 350 mg/kg bw and the NOEL is 125 mg/kg bw. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7af3116d-1d6d-4da0-b707-a39726abb9a8/documents/7ba1d794-a93c-426e-aa55-b43ae02452f7_e1beed3e-2075-40cc-b488-f632466d1ed7.html,,,,,, "Didodecyl 3,3'-thiodipropionate",123-28-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7af3116d-1d6d-4da0-b707-a39726abb9a8/documents/7ba1d794-a93c-426e-aa55-b43ae02452f7_e1beed3e-2075-40cc-b488-f632466d1ed7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,350 mg/kg bw/day,,rat "Didodecyl 3,3'-thiodipropionate",123-28-4,OECD 401: LD50 >5000 mg/kg bw (no mortality)OECD 402: LD50 >2000 mg/kg bw (no mortality) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7af3116d-1d6d-4da0-b707-a39726abb9a8/documents/a6a77827-9cb0-41b5-b687-e492f9ab6a47_e1beed3e-2075-40cc-b488-f632466d1ed7.html,,,,,, "Didodecyl 3,3'-thiodipropionate",123-28-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7af3116d-1d6d-4da0-b707-a39726abb9a8/documents/a6a77827-9cb0-41b5-b687-e492f9ab6a47_e1beed3e-2075-40cc-b488-f632466d1ed7.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "Didodecyl 3,3'-thiodipropionate",123-28-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7af3116d-1d6d-4da0-b707-a39726abb9a8/documents/a6a77827-9cb0-41b5-b687-e492f9ab6a47_e1beed3e-2075-40cc-b488-f632466d1ed7.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Rosin, oligomers",65997-05-9," Several key guideline (OECD 408, 414, 421, & 422 ) studies that investigated the repeated dose toxicity potential of Rosin; Rosin, hydrogenated; Rosin, oligomers; and Rosin, reaction products with formaldehyde following oral dietary exposure in rats are available. The results are summarized below: OECD 408 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL was determined to be 5000 ppm (equivalent to a mean achieved dosage of 335.2 mg/kg bw/day for males and 401.2 mg/kg bw/day for females) based on reduced body weight gains in animals of either sex exposed to 7500 ppm. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The NOAEL for systemic toxicity of Rosin, reaction products with formaldehyde was considered to be 3000 ppm (equivalent to mean achieved dosages of approximately 213.1 mg/kg bw/day or 255.2 mg/kg bw/day for males and females, respectively), based on the effects on body weight, body weight gain and, to a lesser extent, food consumption, observed among females exposed to diets containing 7500 ppm of the test material for ninety days. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): Based on a lack of adverse treatment-related effects observed at the highest concentration tested, the systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 6000 ppm for either sex (equivalent to a mean achieved dosage of 334.5 mg/kg bw/day for males and 399.8 mg/kg bw/day for females). OECD 414 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 2500 ppm (equivalent to a mean achieved dosage of 199.3 mg/kg bw/day) based on lower maternal body weight gain during gestation and an initial effect on food consumption at 7500 ppm and lower maternal body weight gain at 5000 ppm. OECD 421 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 1000 ppm in males (equivalent to 84 mg/kg bw/d) and 3000 ppm in females (equivalent to 309 mg/kg bw/d) based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material. OECD 422 1) Rosin (CAS# 8050 -09 -7): In a key combined repeated dose, reproductive/developmental toxicity screening study (Harlan Laboratories Ltd, 2015a), the sytemic toxicity NOAEL for Tall oil rosin was determined to be 5000 ppm. In another key combined repeated dose, reproductive/developmental toxicity study (Harlan Laboratories Ltd., 2014a), the systemic toxicity NOAEL for Gum Rosin was determined to be 2500 ppm. A NOEL (No Observed Effect Level) for general toxicity could not be established due to effects on body weights at all dose levels in females during the lactation period. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The systemic toxicity NOAEL for Rosin, reaction product with formaldehyde was determined to be 10000 ppm and the NOEL was established at a concentration of 1000 ppm. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): The systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 3000 ppm. Based on the histopathological changes observed in adrenal glands, no NOEL for systemic toxicity was established for females whereas for males it was at the dose level of 1000 ppm. 4) Rosin, oligomers: The systemic toxicity NOAEL for Rosin, oligomers in male rats was determined to be 7500 ppm, based on statistically significant body weight and body weight gain effects observed at the 15000 ppm concentration level. The systemic toxicity NOAEL for female rats was determined to be 3000 ppm, based on effects on body weight and body weight gain in females exposed to the test material at 7500 and 15000 ppm. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86a3229d-c916-4279-973b-24b7cd75b55b/documents/c28ec369-736c-47b6-a92d-1183c93e44ed_d69f2e27-4ce0-4595-9d73-9040cf8fb349.html,,,,,, "Rosin, oligomers",65997-05-9,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86a3229d-c916-4279-973b-24b7cd75b55b/documents/6de6680e-2801-4f0f-8007-f39f8ddc7c22_d69f2e27-4ce0-4595-9d73-9040cf8fb349.html,,,,,, "Rosin, oligomers",65997-05-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86a3229d-c916-4279-973b-24b7cd75b55b/documents/6de6680e-2801-4f0f-8007-f39f8ddc7c22_d69f2e27-4ce0-4595-9d73-9040cf8fb349.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Rosin, oligomers",65997-05-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86a3229d-c916-4279-973b-24b7cd75b55b/documents/6de6680e-2801-4f0f-8007-f39f8ddc7c22_d69f2e27-4ce0-4595-9d73-9040cf8fb349.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Bis(2-methoxyethyl) ether,111-96-6,"Several repeated dose studies with diethylen glycol dimethylether as well as read-across approaches with respective metabolites have been performed.All obtained effect concentrations or levels are liste:Oral (read across to 2-Methoxyethanol, a metabolite of Diethylene glycol dimethyl ether):NOAEL (14 days, drinking water study, male mouse): 200 mg/kg bw/dNOAEL (14 days, drinking water study, female mouse): 600 mg/kg bw/dNOAEL (13 weeks, drinking water study, male/female mouse): < 2000 ppmLOAEL (14 days, drinking water study, male rat): 200 mg/kg bw/dLOAEL (14 days, drinking water study, female rat): 200 mg/kg bw/dNOAEL (13 weeks, drinking water study, male rat): < 750 ppmInhalation:NOAEC (2 weeks, 6h/d, nose only, male rat): 30 ppm (key study)NOAEC (3 weeks, 5 d/w, 6h/d, whole body, male/female rat): 200 ppm (corresponding 318.4 mg/kg bw/d)NOAEC (2 weeks, 5 d/w, 6h/d, nose only, female rat): 370 ppm (corresponding to 589 mg/kg bw/d)LOAEC (2 weeks, 5 d/w, 6h/d, nose only, male rat): 110 ppm (corresponding to 175.1 mg/kg bw/d)NOAEC (5 days, 7h/d, whole body, male mouse): 250 ppmNOAEC (2 weeks, 6h/d, nose only, male rat): < 110 ppm (corresponding to 175.1 mg/kg bw/d) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): No repeated dose toxicity study with oral application have been performed with diethylene glycol dimethyl ether, but sufficient information after inhalation is available. Additionally, data of the main toxic metabolite, 2-methoxyethanol, is available after oral dose administration. Here, a NOAEL of 200 mg/kg bw was observed. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d96ec365-eef9-49a5-a3e0-e0f4764c31b3/documents/IUC5-a67bae52-640d-4fd7-851b-55d68522e122_23467c2a-a36c-4daf-a72e-3d12b536caeb.html,,,,,, Bis(2-methoxyethyl) ether,111-96-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d96ec365-eef9-49a5-a3e0-e0f4764c31b3/documents/IUC5-a67bae52-640d-4fd7-851b-55d68522e122_23467c2a-a36c-4daf-a72e-3d12b536caeb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,, Bis(2-methoxyethyl) ether,111-96-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d96ec365-eef9-49a5-a3e0-e0f4764c31b3/documents/IUC5-a67bae52-640d-4fd7-851b-55d68522e122_23467c2a-a36c-4daf-a72e-3d12b536caeb.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,110 ,, Bis(2-methoxyethyl) ether,111-96-6,"Several acute toxicity studies have been performed or a read-across with ethylene-dimethylether was performed.Oral:- female rats, LD50: 4760 mg/kg bw- female mice, LD50: 2978 mg/kg bwInhalation:- male/female rats, LC0 (7h exposure): 11 mg/L -> 19.3 mg/L (4h calculated exposure)- rats, LC50 (ethylene glycol dimethyl ether; 6h exposure): > 20 mg/LDermal:- female rats, LD50 (ethylene glycol dimethyl ether): > 5000 mg/kg bw Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): obtained from 7 h exposure of a saturated atmosphere. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d96ec365-eef9-49a5-a3e0-e0f4764c31b3/documents/IUC5-5a8d69eb-9cde-4a99-8118-2e74fa9f14b5_23467c2a-a36c-4daf-a72e-3d12b536caeb.html,,,,,, Bis(2-methoxyethyl) ether,111-96-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d96ec365-eef9-49a5-a3e0-e0f4764c31b3/documents/IUC5-5a8d69eb-9cde-4a99-8118-2e74fa9f14b5_23467c2a-a36c-4daf-a72e-3d12b536caeb.html,,oral,LD50,"4,760 mg/kg bw",adverse effect observed, Bis(2-methoxyethyl) ether,111-96-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d96ec365-eef9-49a5-a3e0-e0f4764c31b3/documents/IUC5-5a8d69eb-9cde-4a99-8118-2e74fa9f14b5_23467c2a-a36c-4daf-a72e-3d12b536caeb.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Bis(2-methoxyethyl) ether,111-96-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d96ec365-eef9-49a5-a3e0-e0f4764c31b3/documents/IUC5-5a8d69eb-9cde-4a99-8118-2e74fa9f14b5_23467c2a-a36c-4daf-a72e-3d12b536caeb.html,,inhalation,LC0,11 mg/L,no adverse effect observed, "Dimethyl naphthalene-2,6-dicarboxylate",840-65-3,"Oral route:The NOEL for NDC is >50,000 ppm (>3000 mg/kg b.w./day) NDC in the diet (IIT Research Institute, 1990).Inhalation route:The NOAEC for NDC is >10.02 mg/m3 (IIT Research Institute, 1988).Dermal route:Based upon low human exposure potential and available study data, this endpoint is being waived. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ae071833-08ad-4939-990f-662361308e45/documents/IUC5-fb70ad10-9c59-430a-8542-634fc42d066c_3b6aedeb-9a82-496f-b338-6000acc5325d.html,,,,,, "Dimethyl naphthalene-2,6-dicarboxylate",840-65-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ae071833-08ad-4939-990f-662361308e45/documents/IUC5-fb70ad10-9c59-430a-8542-634fc42d066c_3b6aedeb-9a82-496f-b338-6000acc5325d.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,10.2 mg/m3,,rat "Dimethyl naphthalene-2,6-dicarboxylate",840-65-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ae071833-08ad-4939-990f-662361308e45/documents/IUC5-fb70ad10-9c59-430a-8542-634fc42d066c_3b6aedeb-9a82-496f-b338-6000acc5325d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,000 mg/kg bw/day",,rat "Dimethyl naphthalene-2,6-dicarboxylate",840-65-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ae071833-08ad-4939-990f-662361308e45/documents/IUC5-fb70ad10-9c59-430a-8542-634fc42d066c_3b6aedeb-9a82-496f-b338-6000acc5325d.html,Repeated dose toxicity – local effects,inhalation,NOAEC,10.02 mg/m3,no adverse effect observed,rabbit "Dimethyl naphthalene-2,6-dicarboxylate",840-65-3,"Acute toxicity - Oral: NDC has an LD50 >5,000 mg/kg b.w .Acute toxicity - Inhalation: The 4-hour acute inhalation median lethal concentration (LC50) of NDC in rats in a nose-only exposure is > 2.15 mg/L air.Acute toxicity - Dermal: The acute dermal median lethal dose (LD50) of NDC is > 2,000 mg/kg b.w.. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae071833-08ad-4939-990f-662361308e45/documents/IUC5-651d3389-41e7-4915-abb4-23d3a35a8d77_3b6aedeb-9a82-496f-b338-6000acc5325d.html,,,,,, "Dimethyl naphthalene-2,6-dicarboxylate",840-65-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae071833-08ad-4939-990f-662361308e45/documents/IUC5-651d3389-41e7-4915-abb4-23d3a35a8d77_3b6aedeb-9a82-496f-b338-6000acc5325d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Dimethyl naphthalene-2,6-dicarboxylate",840-65-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae071833-08ad-4939-990f-662361308e45/documents/IUC5-651d3389-41e7-4915-abb4-23d3a35a8d77_3b6aedeb-9a82-496f-b338-6000acc5325d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Dimethyl naphthalene-2,6-dicarboxylate",840-65-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae071833-08ad-4939-990f-662361308e45/documents/IUC5-651d3389-41e7-4915-abb4-23d3a35a8d77_3b6aedeb-9a82-496f-b338-6000acc5325d.html,,inhalation,LC50,2.15 mg/m3,no adverse effect observed, "N,N-dimethyl dec-9-enamide",1356964-77-6,"Oral:Dog subchronic (13 weeks; gavage; mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide) NOAEL (systemic) = 200mg/kg bw/d; NOEL (local) = 40mg/kg bw/d Dermal: No data availableInhalation:No reliable relevant studies available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ae79f2d-2eba-4ef3-a351-2ee153b0f2eb/documents/IUC5-c56921f6-ef43-4af9-831c-4eaacc8c2960_22e29f75-d8cf-458f-b917-efb90199de69.html,,,,,, "N,N-dimethyl dec-9-enamide",1356964-77-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ae79f2d-2eba-4ef3-a351-2ee153b0f2eb/documents/IUC5-c56921f6-ef43-4af9-831c-4eaacc8c2960_22e29f75-d8cf-458f-b917-efb90199de69.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,dog "N,N-dimethyl dec-9-enamide",1356964-77-6,"Acute oral toxicity: GLP study conducted in female Sprague-Dawley rats according to OECD 425 test guideline. The statistical estimated acute oral LD50 was determined to be 550 mg/kg body weight and a 95% PL confidence interval of 265.4 mg/kg to 1520 mg/kg.Acute dermal toxicity: GLP study conducted in rats according to OECD TG 402 using the read-across substance N,N-dimethyldecanamide. LD50 > 5000 mg/kg bwAcute inhalation toxicity: GLP study in rats performed according to OECD TG 403 using the read across substance N,N-dimethyldecan-1 -amide, mixture with N,N-dimethyloctan-1 -amide. LC50 > 3551 mg/m3. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae79f2d-2eba-4ef3-a351-2ee153b0f2eb/documents/IUC5-e5498cad-4137-4af9-931a-eccd6b9b55bd_22e29f75-d8cf-458f-b917-efb90199de69.html,,,,,, "N,N-dimethyl dec-9-enamide",1356964-77-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae79f2d-2eba-4ef3-a351-2ee153b0f2eb/documents/IUC5-e5498cad-4137-4af9-931a-eccd6b9b55bd_22e29f75-d8cf-458f-b917-efb90199de69.html,,oral,LD50,550 mg/kg bw,adverse effect observed, "N,N-dimethyl dec-9-enamide",1356964-77-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae79f2d-2eba-4ef3-a351-2ee153b0f2eb/documents/IUC5-e5498cad-4137-4af9-931a-eccd6b9b55bd_22e29f75-d8cf-458f-b917-efb90199de69.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "N,N-dimethyl dec-9-enamide",1356964-77-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae79f2d-2eba-4ef3-a351-2ee153b0f2eb/documents/IUC5-e5498cad-4137-4af9-931a-eccd6b9b55bd_22e29f75-d8cf-458f-b917-efb90199de69.html,,inhalation,discriminating conc.,"3,551 mg/m3",no adverse effect observed, Dimethyl adipate,627-93-0,"- Oral route (14 days, rat): NOEL = 10000 ppm (equivalent to 980 mg/kg bw)- Dermal route (14 days, rat): NOEL (systemic toxicity) = 1000 mg/kg bw- Inhalation (90 days, rat):       NOEC (respiratory local toxicity) = 50 mg/m3 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1addbdf4-c588-4e30-96a8-460b50f80a27/documents/52ed37d5-936f-4cda-877e-5e35eb3e6909_af5e248b-f3b5-46fe-a41f-5b8743c05bd1.html,,,,,, Dimethyl adipate,627-93-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1addbdf4-c588-4e30-96a8-460b50f80a27/documents/52ed37d5-936f-4cda-877e-5e35eb3e6909_af5e248b-f3b5-46fe-a41f-5b8743c05bd1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,980 mg/kg bw/day,,rat Dimethyl adipate,627-93-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1addbdf4-c588-4e30-96a8-460b50f80a27/documents/52ed37d5-936f-4cda-877e-5e35eb3e6909_af5e248b-f3b5-46fe-a41f-5b8743c05bd1.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat Dimethyl adipate,627-93-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1addbdf4-c588-4e30-96a8-460b50f80a27/documents/52ed37d5-936f-4cda-877e-5e35eb3e6909_af5e248b-f3b5-46fe-a41f-5b8743c05bd1.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,50 mg/m3,,rat Dimethyl adipate,627-93-0,"LD50 (oral, rat) > 5000 mg/kg bw LC50 (inhalation, rat) > 11 mg/L airLD50 (dermal, rabbit) > 5000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1addbdf4-c588-4e30-96a8-460b50f80a27/documents/fa451054-c03d-4614-8957-f76053704e47_af5e248b-f3b5-46fe-a41f-5b8743c05bd1.html,,,,,, Dimethyl adipate,627-93-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1addbdf4-c588-4e30-96a8-460b50f80a27/documents/fa451054-c03d-4614-8957-f76053704e47_af5e248b-f3b5-46fe-a41f-5b8743c05bd1.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Dimethyl adipate,627-93-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1addbdf4-c588-4e30-96a8-460b50f80a27/documents/fa451054-c03d-4614-8957-f76053704e47_af5e248b-f3b5-46fe-a41f-5b8743c05bd1.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Dimethyl adipate,627-93-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1addbdf4-c588-4e30-96a8-460b50f80a27/documents/fa451054-c03d-4614-8957-f76053704e47_af5e248b-f3b5-46fe-a41f-5b8743c05bd1.html,,inhalation,LC50,"11,000 mg/m3",no adverse effect observed, "N,N-dimethyldocosylamine",21542-96-1,"Full details of these endpoints are provided in the IUCLID dossier and they are considered reliable. The substance is considered ""Harmful if swallowed"" (Acute tox 4).Waiving was done according to ANNEX VII colum2 of the REACH regulation: the available information regarding skin irritation indicates that the criteria for classification as corrosive for the skin is met ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a26c1441-cd79-409d-a27e-27a6edba7d6f/documents/IUC5-64692a7d-4178-4ef9-9f39-db5fca03fe46_00ad1e73-b6e6-4ea5-8fa9-ad4de705d358.html,,,,,, 2-methyl-4-phenylpentanol,92585-24-5,"In an OECD TG 407 study, Pamplefleur, formulated in corn oil , was administered to rats by intragastric intubation at dosaqe levels of 5 , 55 or 500 mg/kg/day. Treatment was carried out once daily, for twenty-eight consecutive days. Control animals similarly received corn oil at a dosage volume of 5 ml/kg/day.The 'no adverse effect' level for oral administration of Pamplefleur to rats was considered to be 55 mg/kg/day based on increased adjusted liver weights accompanied with minimal generalised hepatocyte enlargement was seen in both sexes. Adjusted kidney weights were increased in females. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c81f19b-577a-4fdf-bcb8-52c1e45336ac/documents/IUC5-5ad693d7-f808-4b39-969d-7bc241ffcbe0_76852e9f-7cbe-4906-b1b2-53898e94a430.html,,,,,, 2-methyl-4-phenylpentanol,92585-24-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c81f19b-577a-4fdf-bcb8-52c1e45336ac/documents/IUC5-5ad693d7-f808-4b39-969d-7bc241ffcbe0_76852e9f-7cbe-4906-b1b2-53898e94a430.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,55 mg/kg bw/day,,rat 2-methyl-4-phenylpentanol,92585-24-5,"An acute oral study according to OECD Guideline 401 was conducted at test concentrations up to 5000 mg/kg, the LD50 value was calculated to be 3600 mg/kg. Acute dermal: In a study performed according to OECD 402 the LD 50 was found to be greater than 2000 mg/kg of body weight. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c81f19b-577a-4fdf-bcb8-52c1e45336ac/documents/IUC5-2aa385e6-7a63-4d05-9f63-393e1d8a1c91_76852e9f-7cbe-4906-b1b2-53898e94a430.html,,,,,, 2-methyl-4-phenylpentanol,92585-24-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c81f19b-577a-4fdf-bcb8-52c1e45336ac/documents/IUC5-2aa385e6-7a63-4d05-9f63-393e1d8a1c91_76852e9f-7cbe-4906-b1b2-53898e94a430.html,,oral,LD50,"3,600 mg/kg bw",no adverse effect observed, 2-methyl-4-phenylpentanol,92585-24-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c81f19b-577a-4fdf-bcb8-52c1e45336ac/documents/IUC5-2aa385e6-7a63-4d05-9f63-393e1d8a1c91_76852e9f-7cbe-4906-b1b2-53898e94a430.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N-dimethyldecan-1-amide",14433-76-2,"Oral:Dog subchronic (13 weeks; gavage; mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide) NOAEL (systemic) = 200mg/kg bw/d; NOEL (local) = 40mg/kg bw/d (Bayer, 2000) Dermal: No data availableInhalative:No reliable relevant studies available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89e7a132-6b4b-426c-976a-d88dd8a04e0a/documents/68e44758-3cf5-4f4f-b1ec-611b540fa064_2ea4022d-032e-46d2-8958-52d4dd12cc31.html,,,,,, "N,N-dimethyldecan-1-amide",14433-76-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89e7a132-6b4b-426c-976a-d88dd8a04e0a/documents/68e44758-3cf5-4f4f-b1ec-611b540fa064_2ea4022d-032e-46d2-8958-52d4dd12cc31.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,dog "N,N-dimethyldecan-1-amide",14433-76-2,Acute oral toxicity (rat): LD50 > 2000 mg/kg bw (Cognis 1997)Acute dermal toxicity (rat): LD50 > 5000 mg/kg bw (Cognis 1997)Acute inhalative toxicity (rat): LC50 mixture of dimethylamides (mainly C8/C10): > 3551 mg/m3 (Bayer 1991) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89e7a132-6b4b-426c-976a-d88dd8a04e0a/documents/95b6383e-dde9-4112-8404-20e6203e61af_2ea4022d-032e-46d2-8958-52d4dd12cc31.html,,,,,, "N,N-dimethyldecan-1-amide",14433-76-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89e7a132-6b4b-426c-976a-d88dd8a04e0a/documents/95b6383e-dde9-4112-8404-20e6203e61af_2ea4022d-032e-46d2-8958-52d4dd12cc31.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N,N-dimethyldecan-1-amide",14433-76-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89e7a132-6b4b-426c-976a-d88dd8a04e0a/documents/95b6383e-dde9-4112-8404-20e6203e61af_2ea4022d-032e-46d2-8958-52d4dd12cc31.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "N,N-dimethyldecan-1-amide",14433-76-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89e7a132-6b4b-426c-976a-d88dd8a04e0a/documents/95b6383e-dde9-4112-8404-20e6203e61af_2ea4022d-032e-46d2-8958-52d4dd12cc31.html,,inhalation,discriminating conc.,"3,551 mg/m3",no adverse effect observed, Dimethyl carbonate,616-38-6,"90-day oral toxicity study in rats, No Effect Level = 500 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9373845f-a141-489a-be21-ea5c124b9e01/documents/IUC5-59b2e365-068c-4b47-b91c-94ff00f6b566_11e51ad0-c3a0-4c30-a77f-3bfc9164447d.html,,,,,, Dimethyl carbonate,616-38-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9373845f-a141-489a-be21-ea5c124b9e01/documents/IUC5-59b2e365-068c-4b47-b91c-94ff00f6b566_11e51ad0-c3a0-4c30-a77f-3bfc9164447d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,, Dimethyl carbonate,616-38-6,Acute oral LD50 in rats >5000 mg/kg bodyweight.Acute inhaled LD50 in rats (4h) >5.36 mg/L.Acute dermal LD50 in rabbits > 2000 mg/kg bodyweight. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9373845f-a141-489a-be21-ea5c124b9e01/documents/IUC5-eb513b2e-cac7-4a9b-a598-d051aa4a6925_11e51ad0-c3a0-4c30-a77f-3bfc9164447d.html,,,,,, "5,9-dimethyl-4,8-decadienal",762-26-5,Acute oral toxicity: OECD TG 401: > 5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96824cdb-7c74-4f58-95f2-eed778ea3533/documents/f2620334-c8fe-4952-8f2c-9c8343991b34_60fc5b91-e050-4c8d-bbaa-ced34183f72e.html,,,,,, Dimethyl ether,115-10-6," NOAEL = 47106 mg/m3 (2.5% or 25000 ppm in air), being the highest concentration tested in a 2-year chronic study in rat.  ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5465d48d-dfe0-431e-9c44-992acd1d6029/documents/d7f173ed-ec28-465a-84fd-860af16b22e2_cd24a4a5-ef9c-457e-a9a7-efc02cb15a78.html,,,,,, Dimethyl ether,115-10-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5465d48d-dfe0-431e-9c44-992acd1d6029/documents/d7f173ed-ec28-465a-84fd-860af16b22e2_cd24a4a5-ef9c-457e-a9a7-efc02cb15a78.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"47,106 mg/m3",,rat Dimethyl ether,115-10-6, 4h-LC50 = 164000 ppm (309018 mg/m3); 4 -h LOAEL = 84000 ppm (158277 mg/m3) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5465d48d-dfe0-431e-9c44-992acd1d6029/documents/008611c4-e2f1-49cf-9dbb-3ecfe95e30e3_cd24a4a5-ef9c-457e-a9a7-efc02cb15a78.html,,,,,, Dimethyl ether,115-10-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5465d48d-dfe0-431e-9c44-992acd1d6029/documents/008611c4-e2f1-49cf-9dbb-3ecfe95e30e3_cd24a4a5-ef9c-457e-a9a7-efc02cb15a78.html,,inhalation,LC50,"309,018 mg/m3",adverse effect observed, Dimethyl glutarate,1119-40-0,"- Oral route (14 days, rat): NOEL = 10000 ppm (equivalent to 980 mg/kg bw)- Dermal route (14 days, rat): NOEL (systemic toxicity) = 1000 mg/kg bw- Inhalation (90 days, rat):       NOEC (respiratory local toxicity) = 50 mg/m3 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a63b0036-9ef2-4b70-b23c-079dffa487df/documents/25b7a054-202f-47a4-b462-532d2c144813_5ae17bc5-33ef-40b7-844b-e243f1975869.html,,,,,, Dimethyl glutarate,1119-40-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a63b0036-9ef2-4b70-b23c-079dffa487df/documents/25b7a054-202f-47a4-b462-532d2c144813_5ae17bc5-33ef-40b7-844b-e243f1975869.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,980 mg/kg bw/day,,rat Dimethyl glutarate,1119-40-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a63b0036-9ef2-4b70-b23c-079dffa487df/documents/25b7a054-202f-47a4-b462-532d2c144813_5ae17bc5-33ef-40b7-844b-e243f1975869.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat Dimethyl glutarate,1119-40-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a63b0036-9ef2-4b70-b23c-079dffa487df/documents/25b7a054-202f-47a4-b462-532d2c144813_5ae17bc5-33ef-40b7-844b-e243f1975869.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,50 mg/m3,,rat Dimethyl glutarate,1119-40-0,"LD50 (oral, rat) > 5000 mg/kg bw LC50 (inhalation, rat) > 11 mg/L airLD50 (dermal, rat) > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a63b0036-9ef2-4b70-b23c-079dffa487df/documents/62c8e02b-5d37-4dce-9530-66e15094539c_5ae17bc5-33ef-40b7-844b-e243f1975869.html,,,,,, "2,6-dimethylhept-5-enal",106-72-9,"As the NOAEL of 300 mg/kg/d is well above the CLP guideline concentration values for specific target organ toxicity for repeat dose exposure, the substance can be considered not classified for this endpoint. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c3f4b72-0701-45ec-a247-adbc269f9e0d/documents/IUC5-7c33335f-0ea2-48f6-b5c9-cd084f497e52_bff5b612-a69c-41ba-8343-d52a7410356a.html,,,,,, "2,6-dimethylhept-5-enal",106-72-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c3f4b72-0701-45ec-a247-adbc269f9e0d/documents/IUC5-7c33335f-0ea2-48f6-b5c9-cd084f497e52_bff5b612-a69c-41ba-8343-d52a7410356a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2,6-dimethylhept-5-enal",106-72-9,LD50s >5000 mg/kg for both oral and dermal studies. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c3f4b72-0701-45ec-a247-adbc269f9e0d/documents/IUC5-53dbdf78-93e2-403f-a057-8fef734cb020_bff5b612-a69c-41ba-8343-d52a7410356a.html,,,,,, "2,6-dimethylhept-5-enal",106-72-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c3f4b72-0701-45ec-a247-adbc269f9e0d/documents/IUC5-53dbdf78-93e2-403f-a057-8fef734cb020_bff5b612-a69c-41ba-8343-d52a7410356a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,6-dimethylhept-5-enal",106-72-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c3f4b72-0701-45ec-a247-adbc269f9e0d/documents/IUC5-53dbdf78-93e2-403f-a057-8fef734cb020_bff5b612-a69c-41ba-8343-d52a7410356a.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "1,3-dimethylimidazolidin-2-one",80-73-9,"28-day repeated dose toxicity (HRC, 1989) 28-day repeated dose toxicity NOAEL(oral) = 30 mg/kg bw/day   28-day repeated dose toxicity (Biosafety Research Center, 2011) 28-day repeated dose toxicity NOAEL(oral) = 20 mg/kg bw/day Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): This key study was part of a series of animal studies conducted to methods equivalent to modern regulatory standards. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74e805e3-6f02-4f37-869f-845c2771c23f/documents/ca35d7a9-3ecb-424b-90fd-f1c2f3c9f2cd_d4f53893-10a4-44a2-a2b2-b5d47fda6576.html,,,,,, "1,3-dimethylimidazolidin-2-one",80-73-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74e805e3-6f02-4f37-869f-845c2771c23f/documents/ca35d7a9-3ecb-424b-90fd-f1c2f3c9f2cd_d4f53893-10a4-44a2-a2b2-b5d47fda6576.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "1,3-dimethylimidazolidin-2-one",80-73-9,Acute oral toxicity:   deaths occurred in rats at 2000 mg/kg bodyweight with no deaths seen at 300 mg/kg bodyweight.Acute inhaled toxicity:  no data available.Acute dermal toxicity:  no deaths seen in rats exposed at 2000 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74e805e3-6f02-4f37-869f-845c2771c23f/documents/d4ff4ef1-3ca2-49fd-9e55-34445d96f796_d4f53893-10a4-44a2-a2b2-b5d47fda6576.html,,,,,, "1,3-dimethylimidazolidin-2-one",80-73-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74e805e3-6f02-4f37-869f-845c2771c23f/documents/d4ff4ef1-3ca2-49fd-9e55-34445d96f796_d4f53893-10a4-44a2-a2b2-b5d47fda6576.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "1,3-dimethylimidazolidin-2-one",80-73-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74e805e3-6f02-4f37-869f-845c2771c23f/documents/d4ff4ef1-3ca2-49fd-9e55-34445d96f796_d4f53893-10a4-44a2-a2b2-b5d47fda6576.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, 1-(dimethylamino)propan-2-ol,108-16-7," Under the conditions of a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test performed according to OECD TG 422 and GLP, the oral administration of the test substance by gavage to male and female Wistar rats revealed signs of systemic toxicity at a dose level of 375 mg/kg bw/d taking clinical findings in male and female animals into account. Thus, the no observed adverse effect level (NOAEL) for general systemic toxicity was 120 mg/kg bw/d for male for female Wistar rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57c5cf88-a957-4bd7-a360-b3252485c16b/documents/IUC5-8894f30d-553e-45db-bf1f-74812dc3170c_edbc7d6e-d32c-4ae9-aca0-b0ca3ef8d664.html,,,,,, 1-(dimethylamino)propan-2-ol,108-16-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57c5cf88-a957-4bd7-a360-b3252485c16b/documents/IUC5-8894f30d-553e-45db-bf1f-74812dc3170c_edbc7d6e-d32c-4ae9-aca0-b0ca3ef8d664.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat 1-(dimethylamino)propan-2-ol,108-16-7," Acute toxicity data indicate low toxicity: in rats the oral LD50 was 1360 mg/kg bw (comparable to OECD TG 402, non-GLP), and the dermal LD50 was 1232 mg/kg bw (according to OECD TG 402, GLP). No adequate data for the assessment of acute inhalation toxicity are available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57c5cf88-a957-4bd7-a360-b3252485c16b/documents/IUC5-abe1a163-eff3-49f8-b26f-c94bee12ed12_edbc7d6e-d32c-4ae9-aca0-b0ca3ef8d664.html,,,,,, 1-(dimethylamino)propan-2-ol,108-16-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57c5cf88-a957-4bd7-a360-b3252485c16b/documents/IUC5-abe1a163-eff3-49f8-b26f-c94bee12ed12_edbc7d6e-d32c-4ae9-aca0-b0ca3ef8d664.html,,oral,LD50,"1,360 mg/kg bw",adverse effect observed, 1-(dimethylamino)propan-2-ol,108-16-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57c5cf88-a957-4bd7-a360-b3252485c16b/documents/IUC5-abe1a163-eff3-49f8-b26f-c94bee12ed12_edbc7d6e-d32c-4ae9-aca0-b0ca3ef8d664.html,,dermal,LD50,"1,232 mg/kg bw",adverse effect observed, Dimethyl maleate,624-48-6,"A OECD 421 screening study was performed. Increased maternal and paternal deaths (3/12 females and 2/12 males at the highest dose), as well as stomach lesions and salivation were observed. At 200 mg/kg/d only findings like salivation and increased activity were observed, which were considered to be caused by the unpleasant taste or odour of the test substance and therefore are not considered as a toxic effect. Based on the results, the NOAEL for repeated dose toxicity was considered to be 200 mg/kg bw/day.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc629e0d-0577-4794-b79d-10ccd78c60dd/documents/IUC5-bb4a3009-ce91-4dc8-b2eb-84d1dbbd2b07_f3d76366-f59a-4c71-9421-465702065d85.html,,,,,, Dimethyl maleate,624-48-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc629e0d-0577-4794-b79d-10ccd78c60dd/documents/IUC5-bb4a3009-ce91-4dc8-b2eb-84d1dbbd2b07_f3d76366-f59a-4c71-9421-465702065d85.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Dimethyl maleate,624-48-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc629e0d-0577-4794-b79d-10ccd78c60dd/documents/IUC5-bb4a3009-ce91-4dc8-b2eb-84d1dbbd2b07_f3d76366-f59a-4c71-9421-465702065d85.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,60 mg/kg bw/day,,rat Dimethyl maleate,624-48-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc629e0d-0577-4794-b79d-10ccd78c60dd/documents/IUC5-bb4a3009-ce91-4dc8-b2eb-84d1dbbd2b07_f3d76366-f59a-4c71-9421-465702065d85.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.34 mg/cm2,adverse effect observed,rat Dimethyl maleate,624-48-6,"For the acute oral toxicity three studies are available, which gave LD50 values in the range of 1340 to 1909 mg/kg bw. Based on the results, classification as Acute Tox. 4, H302 is warranted in accordance with CLP Regulation 1272/2008. In an acute inhalation study, rats (6 per group) were exposed to saturated vapors (2842 mg/m³) of dimethyl maleate for time periods up to 8 hours. The observation time after exposure was 14 days. The rats exposed for 4 hours survived 14 days. Based on the results, no classification is warranted in accordance with CLP Regulation 1272/2008. In an acute dermal toxicity study no mortality occurred and the LD50 was determined to be greater 2000 mg/kg bw. Based on the results, no classification is warranted in accordance with CLP Regulation 1272/2008. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc629e0d-0577-4794-b79d-10ccd78c60dd/documents/IUC5-9a8373a7-2899-4ab7-8770-cc8e963ddf2a_f3d76366-f59a-4c71-9421-465702065d85.html,,,,,, Dimethyl maleate,624-48-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc629e0d-0577-4794-b79d-10ccd78c60dd/documents/IUC5-9a8373a7-2899-4ab7-8770-cc8e963ddf2a_f3d76366-f59a-4c71-9421-465702065d85.html,,oral,LD50,"1,410 mg/kg bw",adverse effect observed, Dimethyl maleate,624-48-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc629e0d-0577-4794-b79d-10ccd78c60dd/documents/IUC5-9a8373a7-2899-4ab7-8770-cc8e963ddf2a_f3d76366-f59a-4c71-9421-465702065d85.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Dimethyl maleate,624-48-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc629e0d-0577-4794-b79d-10ccd78c60dd/documents/IUC5-9a8373a7-2899-4ab7-8770-cc8e963ddf2a_f3d76366-f59a-4c71-9421-465702065d85.html,,inhalation,LC0,"2,842 mg/m3",adverse effect observed, 2-dimethylaminoethanol,108-01-0,"- Repeated dose toxicity, oral gavage: Millard 2021. Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test accoding to OECD 422 and GLP, conc. tested: 0, 15, 50, 150 mg/kg bw/day. No adverse effects observed. NOAEL is 150 mg/kg bw/day - Repeated dose toxicity, inhalation: Klonne et al., 1987. Dimethylethanolamine: Acute, 2-week and 13-week Inhalation Toxicity Studies in Rats. Comparable to the OECD guideline 413, conc. tested: 8, 24 and 76 ppm (corresponding to 29.2, 87.5 and 277.1 mg/m³). NOEC is 87.5 mg/m³. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Good quality: guideline study and accoding to GLP ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aab77db7-02d8-4077-a69c-5123103cdde4/documents/IUC5-16439e17-5b94-4cc7-9e2b-0b859c1f627e_d64d3788-14cf-41a8-af7c-74f462b254db.html,,,,,, 2-dimethylaminoethanol,108-01-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aab77db7-02d8-4077-a69c-5123103cdde4/documents/IUC5-16439e17-5b94-4cc7-9e2b-0b859c1f627e_d64d3788-14cf-41a8-af7c-74f462b254db.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat 2-dimethylaminoethanol,108-01-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aab77db7-02d8-4077-a69c-5123103cdde4/documents/IUC5-16439e17-5b94-4cc7-9e2b-0b859c1f627e_d64d3788-14cf-41a8-af7c-74f462b254db.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,87.5 mg/m3,,rat 2-dimethylaminoethanol,108-01-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aab77db7-02d8-4077-a69c-5123103cdde4/documents/IUC5-16439e17-5b94-4cc7-9e2b-0b859c1f627e_d64d3788-14cf-41a8-af7c-74f462b254db.html,Repeated dose toxicity – local effects,inhalation,NOAEC,87.5 mg/m3,adverse effect observed,rat 2-dimethylaminoethanol,108-01-0,"Acute toxicity oral: Pharmakon Research International, Inc. Waverly, PA 18471, 1991; according the OECD 401; Sprague Dawley rats, 800, 1200 and 2500 mg/kg bw. Acute toxicity inhalation: Ballantyne & Leung, 1992; Acute Toxicity and Primary Irritancy of Alkylalkanolamines, Vet Human Toxicol 38 (6) Dec. 1996; similar to the OECD 403, rats, 1668, 2408 and 3311 actual measured concentrations; BASF AG. 1969; Industrial hygiene orientating investigation; similar to the OECD 403, rats, rat were exposed sequentially to vapours for 10 and 30 min, 1 h, 3 h and 7 h Acute toxicity dermal: Acute Exposure Dermal Toxicity. Pharmakon Research International, Inc., 1992; New Zealand White rabbit, 3000 mg/kg/bw limit test ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aab77db7-02d8-4077-a69c-5123103cdde4/documents/IUC5-0197482b-71f4-4dd8-8f2a-ad6dc7703d5f_d64d3788-14cf-41a8-af7c-74f462b254db.html,,,,,, 2-dimethylaminoethanol,108-01-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aab77db7-02d8-4077-a69c-5123103cdde4/documents/IUC5-0197482b-71f4-4dd8-8f2a-ad6dc7703d5f_d64d3788-14cf-41a8-af7c-74f462b254db.html,,oral,LD50,"1,182.7 mg/kg bw",adverse effect observed, 2-dimethylaminoethanol,108-01-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aab77db7-02d8-4077-a69c-5123103cdde4/documents/IUC5-0197482b-71f4-4dd8-8f2a-ad6dc7703d5f_d64d3788-14cf-41a8-af7c-74f462b254db.html,,dermal,discriminating dose,"3,000 mg/kg bw",adverse effect observed, 2-dimethylaminoethanol,108-01-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aab77db7-02d8-4077-a69c-5123103cdde4/documents/IUC5-0197482b-71f4-4dd8-8f2a-ad6dc7703d5f_d64d3788-14cf-41a8-af7c-74f462b254db.html,,inhalation,LC50,"5,983 mg/m3",adverse effect observed, Dimethyl oxalate,553-90-2," The acute oral toxicity of the test item dimethyl oxalate was evaluated in female and male Sprague Dawley rats according to OECD 401 and EU Method B.1 guidelines and in compliance with GLP. The test substance induced mortality in the rat following oral administration of a single dose at levels of 2000 (5/5 female, 2/5 male) and 1414 (1/5 female) mg/kg. Main clinical sings after 2000 and 1414 mg/kg were ataxia, hunched posture, lethargy, decreased respiratory rate and laboured respiration. Gross pathology examination showed haemorrhagic lungs, dark liver and pale kidneys for animals died during the study. Kidneys showed to be enlarged with three males and sloughing of the non -glandular epithelium of the stomach was noted with females at dose 2000 mg/kg. At dose 1414 mg/kg pale kidneys were noted at necropsy of animals killed at the end of the study. No mortality or other relevant signs of toxicity were observed following dosing at 1000 mg/kg. The results suggest the LD50 to be 1569 (1366 – 1803) mg/kg bw and indicate the classification of Acute Oral Toxicity Category 4. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/613cb36e-a7d1-41e2-9e03-5ad913d18fb7/documents/00718b41-e470-40cf-9f8d-04a27f1d5ef6_396d3783-a8c5-4ce7-882a-3f951c516499.html,,,,,, Dimethyl oxalate,553-90-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/613cb36e-a7d1-41e2-9e03-5ad913d18fb7/documents/00718b41-e470-40cf-9f8d-04a27f1d5ef6_396d3783-a8c5-4ce7-882a-3f951c516499.html,,oral,LD50,"1,569 mg/kg bw",adverse effect observed, Hexadecyldimethylamine,112-69-6," Data on repeated dose toxicity are available for C10-DMA, C12-14-DMA, C16-DMA and C18-DMA. Two studies, one with C12-14 DMA one with C16-DMA were performed according to OECD TG 408 (90 day oral toxicity studies). Other studies were performed either according to OECD TG 422, OECD TG 407 or OECD TG 421. NOAEL values from the 90-day oral toxicity studies were 75 mg/kg bw/d (C16-DMA) and 225 mg/kg bw/d (C12-14-DMA). NOAEL/NOEL values from the other studies were between 50 and 180 mg/kg bw/d. Subchronic/chronic toxicity of DMAs are also assessed based on the data on read-across source substances DMAOs. A two-year study with C10-16 DMAO is currently used as key study to cover the endpoint subchronic/chronic toxicity. The NOAEL of 42.3 and 52.6 mg/kg/d were obtained for males and females respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4432c226-22bd-414d-adf2-020c11999248/documents/149baf09-bc1f-4eee-9339-104e9f42e486_9983ab1e-dad4-4cab-94e4-fb8defbdf57c.html,,,,,, Hexadecyldimethylamine,112-69-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4432c226-22bd-414d-adf2-020c11999248/documents/149baf09-bc1f-4eee-9339-104e9f42e486_9983ab1e-dad4-4cab-94e4-fb8defbdf57c.html,Chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Hexadecyldimethylamine,112-69-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): good ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4432c226-22bd-414d-adf2-020c11999248/documents/20703b5e-73d9-44a8-8d6e-244a6dbfa02b_9983ab1e-dad4-4cab-94e4-fb8defbdf57c.html,,,,,, Hexadecyldimethylamine,112-69-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4432c226-22bd-414d-adf2-020c11999248/documents/20703b5e-73d9-44a8-8d6e-244a6dbfa02b_9983ab1e-dad4-4cab-94e4-fb8defbdf57c.html,,oral,LD50,"1,015 mg/kg bw",adverse effect observed, "α,α-dimethylphenethyl butyrate",10094-34-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed50ff11-b7f7-4a39-abb2-9b88ba22c902/documents/76a578b5-66b4-4f90-b301-20b8cbcf1a3a_eccda3ff-880e-4aa8-86da-699d89a8229c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "α,α-dimethylphenethyl butyrate",10094-34-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed50ff11-b7f7-4a39-abb2-9b88ba22c902/documents/24a4fed6-88eb-4c6e-8c5c-42ad76b06fdf_eccda3ff-880e-4aa8-86da-699d89a8229c.html,,oral,LD50,"3,300 mg/kg bw",no adverse effect observed, "α,α-dimethylphenethyl butyrate",10094-34-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed50ff11-b7f7-4a39-abb2-9b88ba22c902/documents/24a4fed6-88eb-4c6e-8c5c-42ad76b06fdf_eccda3ff-880e-4aa8-86da-699d89a8229c.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, 4-methyl-4-phenylpentan-2-ol,2035-93-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): One study conducted according to OECD test guideline and allocated a Klimisch score of 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): One study conducted according to OECD test guideline and allocated a Klimisch score of 1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f77705f1-954e-4d44-8ed7-615b0ba0cc9c/documents/IUC5-0baa4ad4-f7a6-4b61-8d34-4d3de806cf34_43301aae-29ef-4434-ad8d-93ad6285d449.html,,,,,, 4-methyl-4-phenylpentan-2-ol,2035-93-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f77705f1-954e-4d44-8ed7-615b0ba0cc9c/documents/IUC5-0baa4ad4-f7a6-4b61-8d34-4d3de806cf34_43301aae-29ef-4434-ad8d-93ad6285d449.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat 4-methyl-4-phenylpentan-2-ol,2035-93-0,No mortality was observed in 6 female Wistar rats in an acute oral toxicity study conducted according to the acute toxic class method (OECD TG 423) at a limit dose of 2000 mg/kg. The LD50 was identified as >2000mg/kg p.o. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f77705f1-954e-4d44-8ed7-615b0ba0cc9c/documents/IUC5-3fd38ece-51a5-4150-a68a-37127f6b6f69_43301aae-29ef-4434-ad8d-93ad6285d449.html,,,,,, 4-methyl-4-phenylpentan-2-ol,2035-93-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f77705f1-954e-4d44-8ed7-615b0ba0cc9c/documents/IUC5-3fd38ece-51a5-4150-a68a-37127f6b6f69_43301aae-29ef-4434-ad8d-93ad6285d449.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2-dimethyl-3-phenylpropanol",13351-61-6,"Acute oral toxicity: The potential of the test item to cause acute oral toxicity was determined in a study equivalent to OECD 401. The LD50 (males) was determined to be 2240 mg/kg bw, the LD50 of females was determined to be 1730 mg/kg bw. The mean LD50 rats was determined to be 1970 mg/kgbw. Acute dermal toxicity: The potential of the test item to cause acute dermal toxicity to rats was determined. No mortality was observed. The LD50 was determined to be >15000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/352fbc8f-a80b-453d-ade9-a2182d43390e/documents/IUC5-ed531dbd-036b-4688-9f1d-36936203c1a4_1e2899e3-8368-4c73-8559-cf2c67437fef.html,,,,,, "2,2-dimethyl-3-phenylpropanol",13351-61-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/352fbc8f-a80b-453d-ade9-a2182d43390e/documents/IUC5-ed531dbd-036b-4688-9f1d-36936203c1a4_1e2899e3-8368-4c73-8559-cf2c67437fef.html,,oral,LD50,"1,970 mg/kg bw",adverse effect observed, "2,2-dimethyl-3-phenylpropanol",13351-61-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/352fbc8f-a80b-453d-ade9-a2182d43390e/documents/IUC5-ed531dbd-036b-4688-9f1d-36936203c1a4_1e2899e3-8368-4c73-8559-cf2c67437fef.html,,dermal,discriminating dose,"15,000 mg/kg bw",no adverse effect observed, Dimethyl phthalate,131-11-3,"DMP: Mouse, 1-year, dermal, similar to OECD 453 (GLP): No histopathologic changes: NOAEL 2700 mg/kg (NTP 1993)   Rat, oral, OECD 422 (GLP): no adverse effects observed, NOAEL 1007 mg/kg bw (males) and 1595 mg/kg bw (females) (BASF 2023) RA to DEP (CAS 84-66-2): Rat, 90days, oral (feed), similar to OECD 408 (no GLP): red. b.w. (gain) and food consumption, increased liver weight: NOAEL = 750mg/kg (Brown 1977) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6f5f758-c41e-4a64-accb-6055e04d3a4f/documents/IUC5-724a7dd4-0b83-40cf-b4e1-bcfb1d4c67a0_d85e8588-2c7d-40de-b467-9b8bbd00207b.html,,,,,, Dimethyl phthalate,131-11-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6f5f758-c41e-4a64-accb-6055e04d3a4f/documents/IUC5-724a7dd4-0b83-40cf-b4e1-bcfb1d4c67a0_d85e8588-2c7d-40de-b467-9b8bbd00207b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,, Dimethyl phthalate,131-11-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6f5f758-c41e-4a64-accb-6055e04d3a4f/documents/IUC5-724a7dd4-0b83-40cf-b4e1-bcfb1d4c67a0_d85e8588-2c7d-40de-b467-9b8bbd00207b.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,700 mg/kg bw/day",, Dimethyl phthalate,131-11-3,"DMP is practically non-toxic after a single ingestion, after short-term inhalation and short-term skin contact.Oral: LD50 = 8200 mg/kg bw (rat)Dermal: LD50 > 12000 mg/kg bw (rabbit, occlusive)Inhalation: LC0 = 10.4 mg/L (rat) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6f5f758-c41e-4a64-accb-6055e04d3a4f/documents/IUC5-5b6c31eb-07e6-4492-91aa-fa4c5e199503_d85e8588-2c7d-40de-b467-9b8bbd00207b.html,,,,,, Dimethyl phthalate,131-11-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6f5f758-c41e-4a64-accb-6055e04d3a4f/documents/IUC5-5b6c31eb-07e6-4492-91aa-fa4c5e199503_d85e8588-2c7d-40de-b467-9b8bbd00207b.html,,oral,LD50,"8,200 mg/kg bw",no adverse effect observed, Dimethyl phthalate,131-11-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6f5f758-c41e-4a64-accb-6055e04d3a4f/documents/IUC5-5b6c31eb-07e6-4492-91aa-fa4c5e199503_d85e8588-2c7d-40de-b467-9b8bbd00207b.html,,dermal,discriminating dose,"12,000 mg/kg bw",no adverse effect observed, Dimethyl phthalate,131-11-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6f5f758-c41e-4a64-accb-6055e04d3a4f/documents/IUC5-5b6c31eb-07e6-4492-91aa-fa4c5e199503_d85e8588-2c7d-40de-b467-9b8bbd00207b.html,,inhalation,discriminating conc.,"10,400 mg/m3",no adverse effect observed, Dimantine,124-28-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): good ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12f860c4-d55d-4b34-a94b-06d93dcb2d06/documents/111a559a-8a5b-4796-942a-eb04b2043a46_613f1777-f36c-4572-8794-e1fa4f9a92c2.html,,,,,, Dimantine,124-28-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12f860c4-d55d-4b34-a94b-06d93dcb2d06/documents/111a559a-8a5b-4796-942a-eb04b2043a46_613f1777-f36c-4572-8794-e1fa4f9a92c2.html,Chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Dimantine,124-28-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): good ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12f860c4-d55d-4b34-a94b-06d93dcb2d06/documents/00581bd6-11e4-433e-a93c-d933f38b4be0_613f1777-f36c-4572-8794-e1fa4f9a92c2.html,,,,,, Dimantine,124-28-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12f860c4-d55d-4b34-a94b-06d93dcb2d06/documents/00581bd6-11e4-433e-a93c-d933f38b4be0_613f1777-f36c-4572-8794-e1fa4f9a92c2.html,,oral,LD50,"1,015 mg/kg bw",adverse effect observed, Dimethyl succinate,106-65-0, Some adverse effects were observed in repeated dose toxicity studies at a high dose/concentration. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/520b08dc-511f-4d2b-a244-7c47aaa537dc/documents/8f3b221e-42f4-4558-bfad-439aa2e6cde6_21e0f7fc-df23-4982-9dcf-06d568d0cdc6.html,,,,,, Dimethyl succinate,106-65-0," Overall, the substance has an acute oral LD50 of about 5000 mg/kg bw. The substance has a inhalation RD50 of 1600 mg/m3. The substance has an acute dermal LD50 of > 5000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/520b08dc-511f-4d2b-a244-7c47aaa537dc/documents/6623426f-b0ca-4c2f-8856-89f74529540e_21e0f7fc-df23-4982-9dcf-06d568d0cdc6.html,,,,,, Dimethyl sulphone,67-71-0," Repeated dose toxicity: oral Oral administration of 1500 mg/kg/day (1.5 g/kg/day) test substance for 90 days did not cause any adverse effects or mortality. Body weight and estimated food consumption were not affected. No hematological or clinical chemical alterations were noted. Renal histology of treated animals was normal.Thus,the no-observed adverse effect level (NOAEL) of test substance in this 90 day gavage study was determined to be 1500 mg/kg/day. Repeated dose toxicity: inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance Dimethyl sulfone, methanesulfonylmethane (67-71-0) which is reported as 0.0073581053 mmHg. As the particle size distribution of the substance dimthyl sulphone, the majority of the particles were found to be in the size of 150 micrometer which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical the particle size distribution is highly unlikely. Therefore this study is considered for waiver.   Repeated dose toxicity: dermal The acute toxicity value for Dimethyl sulfone, methanesulfonylmethane (67-71-0) (as provided in section 7.2.3) is >5000 mg/kg body weight. The substance was also found to be not irrtating to skin. Also, given the use of the chemical as dietary supplements used in a variety of conditions including pain, inflammation,allergies, arthritis, parasitic infections and the maintenance of normal keratin levels in hair, skin and nails.; repeated exposure by the dermal route is unlikely. Thus, it is expected that dimethyl sulphone shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no dermal absorption data as well as no data available that suggests that dimethyl sulphone shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa17946d-0498-4abb-bbd2-553baaa889d3/documents/3baa6ae4-e694-4205-babc-59afaf6e985e_c87ac75e-b949-4c80-9672-1edef34769ec.html,,,,,, Dimethyl sulphone,67-71-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa17946d-0498-4abb-bbd2-553baaa889d3/documents/3baa6ae4-e694-4205-babc-59afaf6e985e_c87ac75e-b949-4c80-9672-1edef34769ec.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,500 mg/kg bw/day",,rat Dimethyl sulphone,67-71-0," Acute oral toxicity:  Acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The studies concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  Acute Inhalation toxicity dose (LC50) was considered based on study conducted on rats. The LC50 value was considered to be >600 mg/L (600000 mg/m3). The study concluded that the LC50 value is >5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute Inhalation toxicity. Acute Dermal toxicity:  The acute dermal toxicity dose (LD50) was considered based on study conducted on rabbits for the test chemical. The LD50 value was considered to be >5000 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa17946d-0498-4abb-bbd2-553baaa889d3/documents/58cd4d50-4b13-4dec-a161-d2fffb12b774_c87ac75e-b949-4c80-9672-1edef34769ec.html,,,,,, Dimethyl sulphone,67-71-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa17946d-0498-4abb-bbd2-553baaa889d3/documents/58cd4d50-4b13-4dec-a161-d2fffb12b774_c87ac75e-b949-4c80-9672-1edef34769ec.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dimethyl sulphone,67-71-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa17946d-0498-4abb-bbd2-553baaa889d3/documents/58cd4d50-4b13-4dec-a161-d2fffb12b774_c87ac75e-b949-4c80-9672-1edef34769ec.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Dimethyl sulphone,67-71-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa17946d-0498-4abb-bbd2-553baaa889d3/documents/58cd4d50-4b13-4dec-a161-d2fffb12b774_c87ac75e-b949-4c80-9672-1edef34769ec.html,,inhalation,LC50,"600,000 mg/m3",no adverse effect observed, Dimethyl sulphide,75-18-3,"Oral route of exposureGroups of male and female rats were given doses of dimethyl sulphide in corn oil by gavage for 2 (5/sex/group), 6 (5/sex/group), or 14 (15/sex/group) weeks at doses of 0, 2.5, 25, or 250 mg/kg bw/day (Butterworth et al., 1975). No treatment-related effects were observed for body weights, food consumption, water consumption, hematology, and blood chemistry. Organ weights showed statistically significant increase in relative brain weight (to bodyweight) of female rats in the 250 mg/kg bw/day group at the 2-week interval. At 6 weeks, significant decreases in absolute, but not relative, heart weights were noted in these females. At 14 weeks, in male rats, absolute small intestine weights were significantly higher at all dose levels compared to the control group, and the relative small intestine weights were significantly increased at the highest two doses but not at the lowest dose.Females, dosed at 250 mg/kg bw/day, had statistically significant decreased absolute and relative thyroid weights (by 23 percent each).However, in males of this group, the relative thyroid weights were higher (by 19 percent).These organ weight changes could not be correlated with histopathological findings. Histopathological examination revealed some degree of fatty degeneration of the liver cells and some chronic inflammation of lungs and kidneys.The incidence and severity of these changes were comparable in treated and control animals.No abnormalities were seen in testes and ovaries.The NOAEL was 250 mg/kg bw/day. Inhalation route of exposureA Testing Proposal was submitted to conduct a study according to the OECD Testing Guideline 413, as inhalation is a relevant route of exposure considering the properties of the substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c34575b7-6f9c-4cd0-b2bb-f9bfc60f2fdc/documents/IUC5-d1c2171c-da71-4024-aa37-164304197949_dcee5830-3469-477e-ab2b-5bdf08d5cb10.html,,,,,, Dimethyl sulphide,75-18-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c34575b7-6f9c-4cd0-b2bb-f9bfc60f2fdc/documents/IUC5-d1c2171c-da71-4024-aa37-164304197949_dcee5830-3469-477e-ab2b-5bdf08d5cb10.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Dimethyl sulphide,75-18-3,"No mortality was observed when animals received a single dose of 2000 mg/kg bw of dimethyl sulphide via the oral and dermal routes. When exposed to the substance via inhalation for 4 hours, the LC50 was 40250 ppm, equivalent to 102 mg/L (vapour). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c34575b7-6f9c-4cd0-b2bb-f9bfc60f2fdc/documents/IUC5-438618fc-cee3-4eb0-8b03-572442dddf58_dcee5830-3469-477e-ab2b-5bdf08d5cb10.html,,,,,, Dimethyl sulphide,75-18-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c34575b7-6f9c-4cd0-b2bb-f9bfc60f2fdc/documents/IUC5-438618fc-cee3-4eb0-8b03-572442dddf58_dcee5830-3469-477e-ab2b-5bdf08d5cb10.html,,oral,LD0,"2,000 mg/kg bw",no adverse effect observed, Dimethyl sulphide,75-18-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c34575b7-6f9c-4cd0-b2bb-f9bfc60f2fdc/documents/IUC5-438618fc-cee3-4eb0-8b03-572442dddf58_dcee5830-3469-477e-ab2b-5bdf08d5cb10.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, Dimethyl sulphide,75-18-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c34575b7-6f9c-4cd0-b2bb-f9bfc60f2fdc/documents/IUC5-438618fc-cee3-4eb0-8b03-572442dddf58_dcee5830-3469-477e-ab2b-5bdf08d5cb10.html,,inhalation,LC50,"102,000 mg/m3",no adverse effect observed, "1,3-dimethylbut-3-enyl isobutyrate",80118-06-5,"Acute toxicity: oral: LD50 Combined > 5000 mg/kg bw (similar to OECD 401, rats, K, rel.2);Acute toxicity dermal: no study availableAcute toxicity inhalation: no study available ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/324dcab1-4f6c-4ba0-87f5-b700c8b6744d/documents/IUC5-8127aef5-e22d-4610-8671-7abf62b2921f_52b34b4a-cd5d-475b-a3b4-f83ed4d94682.html,,,,,, "1,3-dimethylbut-3-enyl isobutyrate",80118-06-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/324dcab1-4f6c-4ba0-87f5-b700c8b6744d/documents/IUC5-8127aef5-e22d-4610-8671-7abf62b2921f_52b34b4a-cd5d-475b-a3b4-f83ed4d94682.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Dimethylcyclohex-3-ene-1-carbaldehyde,27939-60-2,"Vertoliff repeated dose information from a rat oral gavage OECD TG 407 study: NOAEL for systemic effects is 500 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): For repeated dose toxicity one subacute oral study is available performed with Vertoliff according to OECD guideline 407 in compliance with GLP. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db1bed2c-425c-4cbd-926f-de4168428d4a/documents/66814262-ee50-4414-81aa-85c32eae8ed1_d1033b76-2a48-4089-9e97-885e43d828cf.html,,,,,, Dimethylcyclohex-3-ene-1-carbaldehyde,27939-60-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db1bed2c-425c-4cbd-926f-de4168428d4a/documents/66814262-ee50-4414-81aa-85c32eae8ed1_d1033b76-2a48-4089-9e97-885e43d828cf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Dimethylcyclohex-3-ene-1-carbaldehyde,27939-60-2,Vertoliff acute oral toxicity is derived from the analogue Triplal for which a study similar to OECD TG 401 was performed: LD50 rat = 3900 mg/kg bw Acute inhalation toxicity LC50 route to route extrapolation is > 10140 mg/m³ Vertoliff acute dermal toxicity is derived from the analogue Triplal for which a study similar to OECD 402 with rabbits was performed: LD50 > 5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db1bed2c-425c-4cbd-926f-de4168428d4a/documents/b27755ea-8611-4cb3-a6cd-3a6d1e30b9af_d1033b76-2a48-4089-9e97-885e43d828cf.html,,,,,, "2,2-dimethyl-3-(3-methylpenta-2,4-dienyl)oxirane",69103-20-4,"Oral: LD50= > 5000 mg/kg bw, male rat, equiv. to OECD 401, M B Research Laboratories Inc. 1979Dermal: LD50= > 2000 mg/kg bw, male/female rabbit, equiv. to OECD 402, M B Research Laboratories Inc. 1979 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efe3f40e-5194-4fe2-8d10-a4cc7fe65380/documents/IUC5-5674d4aa-6950-42f9-ab02-f9421a1aae91_16315b0c-3a44-4fc3-b709-5b8e27ff4796.html,,,,,, "2,2-dimethyl-3-(3-methylpenta-2,4-dienyl)oxirane",69103-20-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efe3f40e-5194-4fe2-8d10-a4cc7fe65380/documents/IUC5-5674d4aa-6950-42f9-ab02-f9421a1aae91_16315b0c-3a44-4fc3-b709-5b8e27ff4796.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2,2-dimethyl-3-(3-methylpenta-2,4-dienyl)oxirane",69103-20-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efe3f40e-5194-4fe2-8d10-a4cc7fe65380/documents/IUC5-5674d4aa-6950-42f9-ab02-f9421a1aae91_16315b0c-3a44-4fc3-b709-5b8e27ff4796.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "6,6-dimethoxy-2,5,5-trimethylhex-2-ene",67674-46-8, The experimental data on the target substance and the QSAR prediction on rats and mice confirm the lack of toxicity of methyl pamplemousse in an in vivo test system post single application of the test substance. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b16b96f0-b56c-457b-8247-d4ad4a77438e/documents/b84cc18b-0e1e-44c2-9b01-7e08ecd4e260_cda526cf-c2bb-41d2-89a3-1451cad75c80.html,,,,,, "N,N-dimethylacrylamide",2680-03-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3cd0c638-e46f-483a-8434-0d17613dd241/documents/b7372a94-23cb-4dbb-9951-c4c4d4e13ad3_aa408821-d10e-4872-aea2-67f66efba9fb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "N,N-dimethylacrylamide",2680-03-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3cd0c638-e46f-483a-8434-0d17613dd241/documents/b7372a94-23cb-4dbb-9951-c4c4d4e13ad3_aa408821-d10e-4872-aea2-67f66efba9fb.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rat "N,N-dimethylacrylamide",2680-03-7,"LD50(oral) was >215 and <464 mg/kg bw. LC50(inhalation, vapour, 1h) was >3.16 mg/L. No mortality occurred. LD50(dermal) can be assumed to be in the range of > 500 -2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cd0c638-e46f-483a-8434-0d17613dd241/documents/IUC5-7268f19a-485e-4f10-a64f-d1253d71e25e_aa408821-d10e-4872-aea2-67f66efba9fb.html,,,,,, "N,N-dimethylacrylamide",2680-03-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cd0c638-e46f-483a-8434-0d17613dd241/documents/IUC5-7268f19a-485e-4f10-a64f-d1253d71e25e_aa408821-d10e-4872-aea2-67f66efba9fb.html,,oral,LD50,> 215 mg/kg bw,adverse effect observed, "N,N-dimethylacrylamide",2680-03-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cd0c638-e46f-483a-8434-0d17613dd241/documents/IUC5-7268f19a-485e-4f10-a64f-d1253d71e25e_aa408821-d10e-4872-aea2-67f66efba9fb.html,,dermal,LD50,> 500 mg/kg bw,adverse effect observed, "N,N-dimethylacrylamide",2680-03-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cd0c638-e46f-483a-8434-0d17613dd241/documents/IUC5-7268f19a-485e-4f10-a64f-d1253d71e25e_aa408821-d10e-4872-aea2-67f66efba9fb.html,,inhalation,LC50,> 3.16 mg/L,no adverse effect observed, 2-(dimethylamino)-2-methylpropan-1-ol,7005-47-2,"Oral (OECD 408), 90 days, rat:NOAEL (systemic) = 300 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ad8dd11-411c-4913-af35-63eb6926f388/documents/IUC5-d0697de4-9f11-4fa5-8548-8f2d80f6f07f_db61c72c-0111-4392-b55e-af648f272abe.html,,,,,, 2-(dimethylamino)-2-methylpropan-1-ol,7005-47-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ad8dd11-411c-4913-af35-63eb6926f388/documents/IUC5-d0697de4-9f11-4fa5-8548-8f2d80f6f07f_db61c72c-0111-4392-b55e-af648f272abe.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 2-(dimethylamino)-2-methylpropan-1-ol,7005-47-2,"Oral (similar to OECD 401), rat: LD50 = 1656 mg/kg bw (female), 1767 mg/kg bw (male)Dermal (similar to OECD 402), rabbit: LD50 > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ad8dd11-411c-4913-af35-63eb6926f388/documents/IUC5-a5f5fc8a-0a72-4333-99ae-b08db758e5bc_db61c72c-0111-4392-b55e-af648f272abe.html,,,,,, 2-(dimethylamino)-2-methylpropan-1-ol,7005-47-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ad8dd11-411c-4913-af35-63eb6926f388/documents/IUC5-a5f5fc8a-0a72-4333-99ae-b08db758e5bc_db61c72c-0111-4392-b55e-af648f272abe.html,,oral,LD50,"1,656 mg/kg bw",adverse effect observed, 2-dimethylaminoethyl methacrylate,2867-47-2," Key study: In a recently performed subchronic oral toxicity study in rats (OECD TG 408) with additional neurotoxicity screening in rats, the NOAEL for systemic toxicity was determined to the highest dose administered, 500 mg/kg/d. There was no evidence for the induction of damage of the nerve system which was indicated in a former study (OECD TG 422) at a dose of 1000 mg/kg/d. The NOAEL for the repeated dose toxicity by oral gavage in the OECD TG 422 study was determined to be 200 mg/kg/day. The overall oral NOAEL was determined to be 500 mg/kg bw/d due to the absence of neurotoxic effects in the guideline-conform 90 d-study. A repeated inhalation study in rats for 3 weeks revealed a NOAEC of 100 ppm. Nose and eye irritation was observed at 250 ppm (LOEL). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6727765-83ca-4b0c-9b0d-4f559779290a/documents/84fc40b4-35f7-4087-b48d-3d431094d784_33b83237-ec32-40fc-b015-b55f62e6900e.html,,,,,, 2-dimethylaminoethyl methacrylate,2867-47-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6727765-83ca-4b0c-9b0d-4f559779290a/documents/84fc40b4-35f7-4087-b48d-3d431094d784_33b83237-ec32-40fc-b015-b55f62e6900e.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,643 mg/m3,,rat 2-dimethylaminoethyl methacrylate,2867-47-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6727765-83ca-4b0c-9b0d-4f559779290a/documents/84fc40b4-35f7-4087-b48d-3d431094d784_33b83237-ec32-40fc-b015-b55f62e6900e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat 2-dimethylaminoethyl methacrylate,2867-47-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6727765-83ca-4b0c-9b0d-4f559779290a/documents/84fc40b4-35f7-4087-b48d-3d431094d784_33b83237-ec32-40fc-b015-b55f62e6900e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,643 mg/m3,adverse effect observed,rat 2-dimethylaminoethyl methacrylate,2867-47-2," No mortality occurred in a well-conducted GLP guideline study (OECD TG 401) at the dose level of 2000 mg/kg. Therefore, the acute oral LD50 of this substance is considered to be higher than 2000 mg/kg bw. No mortality occurred in a well-conducted GLP guideline study (OECD TG 402) at the dose level of 2000 mg/kg. Therefore, the acute dermal LD50 of this substance is considered to be higher than 2000 mg/kg bw. According to a report on the acute 4-hour inhalation toxicity in rats the acute inhalation LC50 of this substance is considered to be 620 mg/m³. The reliability of this value is not assignable since no sufficiently detailed data were available for assessment. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6727765-83ca-4b0c-9b0d-4f559779290a/documents/3bf41471-31e6-4961-84d8-9334b19f2414_33b83237-ec32-40fc-b015-b55f62e6900e.html,,,,,, 2-dimethylaminoethyl methacrylate,2867-47-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6727765-83ca-4b0c-9b0d-4f559779290a/documents/3bf41471-31e6-4961-84d8-9334b19f2414_33b83237-ec32-40fc-b015-b55f62e6900e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-dimethylaminoethyl methacrylate,2867-47-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6727765-83ca-4b0c-9b0d-4f559779290a/documents/3bf41471-31e6-4961-84d8-9334b19f2414_33b83237-ec32-40fc-b015-b55f62e6900e.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, N-[3-(dimethylamino)propyl]methacrylamide,5205-93-6, No signs o adverse effects in the highest dose group (300 mg/kg/d) of male/female animals in a subchronic repeated dose toxicity study OECD 408 by oral application. Subacute effects in an OECD 422 study by oral application at 400 mg/kg/d could not be confirmed. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9dcee90f-464b-4989-a867-213bdb4650c7/documents/e539b608-7c70-48ae-9f69-478665dd398c_7f4f562f-203d-48e4-ae0e-985981b37d96.html,,,,,, N-[3-(dimethylamino)propyl]methacrylamide,5205-93-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9dcee90f-464b-4989-a867-213bdb4650c7/documents/e539b608-7c70-48ae-9f69-478665dd398c_7f4f562f-203d-48e4-ae0e-985981b37d96.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat N-[3-(dimethylamino)propyl]methacrylamide,5205-93-6," N-[3-Dimethylamino)propyl]methacrylamide is of low acute toxicity in tests by oral or dermal administration (LD50: > 2000 mg/kg, (Mellon Institute, Chemical Hygiene Fellowship (CHF), 1973) or by inhalation. The data requirements with regard to REACH legislation, annex VII – X, are fulfilled. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9dcee90f-464b-4989-a867-213bdb4650c7/documents/bc08ba38-9bba-47aa-b880-af0af9d63eb9_7f4f562f-203d-48e4-ae0e-985981b37d96.html,,,,,, N-[3-(dimethylamino)propyl]methacrylamide,5205-93-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9dcee90f-464b-4989-a867-213bdb4650c7/documents/bc08ba38-9bba-47aa-b880-af0af9d63eb9_7f4f562f-203d-48e4-ae0e-985981b37d96.html,,oral,LD50,"3,334 mg/kg bw",no adverse effect observed, N-[3-(dimethylamino)propyl]methacrylamide,5205-93-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9dcee90f-464b-4989-a867-213bdb4650c7/documents/bc08ba38-9bba-47aa-b880-af0af9d63eb9_7f4f562f-203d-48e4-ae0e-985981b37d96.html,,dermal,LD50,"2,355 mg/kg bw",no adverse effect observed, 3-aminopropyldimethylamine,109-55-7,"OECD 407 (DMAPA)   A 28-day oral toxicity study according to OECD guideline 407 was performed on Wistar rats exposed to the test substance at 0, 10, 50, and 250 mg/kg bw/day. One of five high dose males showed impaired respiration. Four out of ten high dose females died. Decreased spontaneous activity, stilted gait, swollen abdomen, and impaired respiration were observed between days 11 and 24, mainly in the females that died. In the four high-dose females that died, macroscopically discoloration of lungs with multiple red spots on its surfaces and foamy content were observed among other findings. Histopathology revealed lesions, which included congestion of organs, pulmonary hemorrhage, and edema. In addition, one of the females exhibited marked loss of lymphatic follicles of the spleen with massive marginal zone and periarteriolar lymphoid sheath atrophy. The high-dose male rat that exhibited clinical signs had focal ballooning degeneration of the squamous epithelium of the fore-stomach. These data demonstrate that DMAPA induces clinical symptoms, systemic toxicity in male and additionally mortality in female rats when administered 28 times during 29 days at the dose level of 250 mg/kg body weight. The female rats seem to be more sensitive. Although a direct systemic-toxic effect on the respiratory tract cannot be excluded, it can be considered as more likely that the observed findings are related to the oral treatment with this corrosive substance. Due to gavage either local placement in the laryngeal/pharyngeal area or secondary aspiration after reflux from the stomach/esophagus appeared reasonable as noted for other corrosive substances too. The NOAEL was 50 mg/kg bw/day (Hoechst 1996; reliability score: 1).       OECD 408 (DEAPA)   In a standard subchronic toxicity study (OECD TG 408/GLP) with the structurally related DEAPA Sprague-Dawley rats were treated daily by gavage with the test item for 13 weeks. Male and female rats received dietary target doses of 0, 50, 250 or 750 mg/kg bw/d of DEAPA. During the treatment period, three females given 750 mg/kg bw/d showed clinical signs which were considered to be adverse (i.e. hunched posture, dyspnea, abdominal, loud breathing and/or bent head). One female given 750 mg/kg bw/d more severely affected, showed signs of very poor clinical condition and was sacrificed in week 11. Body weight gain was slightly lower but not adversely effected in males given 750 mg/kg bw/d. Food consumption was not affected by the test item treatment. No ophthalmology findings were observed at the end of the treatment period. Estrous cycle was not altered by the test item treatment. The epididymal sperm motility and morphology and the spermatozoa count were unaffected by the test item treatment. At hematology only minimal to very slight alterations were noted what were finally considered as not adverse. The same was true for none adverse findings in clinical chemistry and urinalysis. Moreover, all changes in hematology, clinical chemistry and urinalysis were completely reversible. At the end of the treatment period, only minor and non-adverse findings were noted in isolated organs and/or animals by histopathology at 750 mg/kg bw/d in both sexes and at 250 mg/kg bw/d in single females. Especially in the females, some of them may be considered as stress-related and due to the irritant potential. Finally, the NOAEL for males was considered to be 750 mg/kg bw/d, and for females 250 mg/kg bw/d predominantly due to the severe clinical findings including death (Consortium Alkylamines 42760 TCR).   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72a7349d-7071-470f-94e1-f4189a1a3497/documents/IUC5-265d54a0-f4e6-4944-bc26-3314f13063c7_03fb516f-4910-460c-84fe-cf14acd44f15.html,,,,,, 3-aminopropyldimethylamine,109-55-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72a7349d-7071-470f-94e1-f4189a1a3497/documents/IUC5-265d54a0-f4e6-4944-bc26-3314f13063c7_03fb516f-4910-460c-84fe-cf14acd44f15.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 3-aminopropyldimethylamine,109-55-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP and OECD Guideline study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The weight-of-evidence studies were conducted according to and equivalent or similar to an OECD Guideline. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Three study records were used for a weight-of-evidence approach, two of the studies were GLP and OECD Guideline compliant. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72a7349d-7071-470f-94e1-f4189a1a3497/documents/IUC5-aa563e2c-a7b7-4aff-8470-ef02f9f4cd98_03fb516f-4910-460c-84fe-cf14acd44f15.html,,,,,, 3-aminopropyldimethylamine,109-55-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72a7349d-7071-470f-94e1-f4189a1a3497/documents/IUC5-aa563e2c-a7b7-4aff-8470-ef02f9f4cd98_03fb516f-4910-460c-84fe-cf14acd44f15.html,,oral,LD50,410 mg/kg bw,adverse effect observed, 3-aminopropyldimethylamine,109-55-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72a7349d-7071-470f-94e1-f4189a1a3497/documents/IUC5-aa563e2c-a7b7-4aff-8470-ef02f9f4cd98_03fb516f-4910-460c-84fe-cf14acd44f15.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, 3-aminopropyldimethylamine,109-55-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72a7349d-7071-470f-94e1-f4189a1a3497/documents/IUC5-aa563e2c-a7b7-4aff-8470-ef02f9f4cd98_03fb516f-4910-460c-84fe-cf14acd44f15.html,,inhalation,discriminating conc.,"4,310 mg/m3",adverse effect observed, 2-methyl-1-phenylpropan-2-ol,100-86-7," Read-across to PEA (CAS No. 60-12-8) - Repeated dose toxicity (dermal, subchronic): NOEL = 500 mg/kg bw/day (Equivalent or similar to OECD 411) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44f0d1fc-b2fe-463b-970f-a0af2dfedb6e/documents/65b1691e-9c40-4d94-877b-fff4e1fa8820_32fb6eb5-2084-49e2-a645-5a408ee18427.html,,,,,, 2-methyl-1-phenylpropan-2-ol,100-86-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44f0d1fc-b2fe-463b-970f-a0af2dfedb6e/documents/65b1691e-9c40-4d94-877b-fff4e1fa8820_32fb6eb5-2084-49e2-a645-5a408ee18427.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rat 2-methyl-1-phenylpropan-2-ol,100-86-7, Acute oral toxicity: LD50 (male/female) = 1280 mg/kg bw with 95% confidence limits of 934 -1770 mg/kg bw (equivalent or similar to OECD 401) Read-across to PEA (CAS No. 60 -12 -8) - Acute inhalation toxicity: LC50 (male/female) = > 4.63 mg/L (nominal concentration) (Equivalent or similar to OECD 403/GLP) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44f0d1fc-b2fe-463b-970f-a0af2dfedb6e/documents/fee103c1-49c6-4a4c-99d0-dee784bf31d3_32fb6eb5-2084-49e2-a645-5a408ee18427.html,,,,,, 2-methyl-1-phenylpropan-2-ol,100-86-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44f0d1fc-b2fe-463b-970f-a0af2dfedb6e/documents/fee103c1-49c6-4a4c-99d0-dee784bf31d3_32fb6eb5-2084-49e2-a645-5a408ee18427.html,,oral,LD50,"1,280 mg/kg bw",adverse effect observed, 2-methyl-1-phenylpropan-2-ol,100-86-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44f0d1fc-b2fe-463b-970f-a0af2dfedb6e/documents/fee103c1-49c6-4a4c-99d0-dee784bf31d3_32fb6eb5-2084-49e2-a645-5a408ee18427.html,,inhalation,LC50,4.63 mg/m3,no adverse effect observed, "α,α-dimethylphenethyl acetate",151-05-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/529f3e67-75ed-4e4c-a60d-530f5c6092a1/documents/08057d59-9458-4a24-9af4-507d6819e8a0_159bc41f-6fe6-403f-98ac-bd9d8cb9f323.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "α,α-dimethylphenethyl acetate",151-05-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/529f3e67-75ed-4e4c-a60d-530f5c6092a1/documents/1e4535e2-39b4-45d0-9daa-46d35a6e934c_159bc41f-6fe6-403f-98ac-bd9d8cb9f323.html,,oral,LD50,"3,300 mg/kg bw",no adverse effect observed, "α,α-dimethylphenethyl acetate",151-05-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/529f3e67-75ed-4e4c-a60d-530f5c6092a1/documents/1e4535e2-39b4-45d0-9daa-46d35a6e934c_159bc41f-6fe6-403f-98ac-bd9d8cb9f323.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, "1,5-dimethylbicyclo[3.2.1]octan-8-one oxime",75147-23-8,The test item has a mean LD50 of 730 mg/kg and is therefore considered acute toxic category 4 via the oral route. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32e40acd-f577-401a-ac37-9efb0933f297/documents/IUC5-c5f6205f-2b3d-448d-b02c-89f9896274dd_7c1c079f-b937-48a9-9779-fdbfdb07b460.html,,,,,, "1,5-dimethylbicyclo[3.2.1]octan-8-one oxime",75147-23-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32e40acd-f577-401a-ac37-9efb0933f297/documents/IUC5-c5f6205f-2b3d-448d-b02c-89f9896274dd_7c1c079f-b937-48a9-9779-fdbfdb07b460.html,,oral,LD50,730 mg/kg bw,adverse effect observed, "1-(2,3-dimethyl-2-bicyclo[2.2.1]heptanyl)ethanone",854737-10-3," Oral LD50 (rats / females) > 2000 mg/kg bw (OECD 423, K, Rel.2, class method in rats) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f569582-a198-4650-950d-3df5875d4f2f/documents/8646d7f4-51b4-41ab-85e2-473c8ce4702b_e39d1ecb-b3f4-4bf9-94c6-b2c373efc29a.html,,,,,, "1-(2,3-dimethyl-2-bicyclo[2.2.1]heptanyl)ethanone",854737-10-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f569582-a198-4650-950d-3df5875d4f2f/documents/8646d7f4-51b4-41ab-85e2-473c8ce4702b_e39d1ecb-b3f4-4bf9-94c6-b2c373efc29a.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1-(5,5-dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one",56973-85-4," Extended-Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test: NOAEL = 700 ppm (based on reduced food consumption of females throughout the post-coitum and lactation period at 2000 ppm (approximately 30-40% lower than controls), hypertrophy of the urothelium of the urinary bladder in females at 2000 ppm and renal changes in males at 2000 ppm (hyaline droplet accumulation, accompanied by renal tubular basophilia and granular casts and associated higher renal weight). [700 ppm in the diet corresponded to mean daily test item intake levels of 51 mg/kg bw/day in males, and 59 (pre-mating period), 87 (post-coitum period) and 129 (lactation period) mg/kg bw/day in females.] ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00a4900c-6319-4840-8840-20fef3e5e6b3/documents/7bc38426-eba8-4385-bdd0-5700e8cd5282_385932a6-fe44-4f1f-bf62-03073955519f.html,,,,,, "1-(5,5-dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one",56973-85-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00a4900c-6319-4840-8840-20fef3e5e6b3/documents/7bc38426-eba8-4385-bdd0-5700e8cd5282_385932a6-fe44-4f1f-bf62-03073955519f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,51 mg/kg bw/day,,rat "1-(5,5-dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one",56973-85-4," Acute toxicity: oral: LD50 > 2500 mg/kg bw (WoE, Target: eq. OECD 401 in rats, non-GLP, rel.2 & Source: OECD 401 in rats, GLP, rel.1) Acute toxicity: inhalation: waiver Acute toxicity: dermal: LD50 expected to be > 2500 mg/kg bw (rabbits, non-OECD, non-GLP, rel.4, S + waiver) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00a4900c-6319-4840-8840-20fef3e5e6b3/documents/c80f1c06-29b4-40be-ada6-a495b37f2837_385932a6-fe44-4f1f-bf62-03073955519f.html,,,,,, "1-(5,5-dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one",56973-85-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00a4900c-6319-4840-8840-20fef3e5e6b3/documents/c80f1c06-29b4-40be-ada6-a495b37f2837_385932a6-fe44-4f1f-bf62-03073955519f.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "1-(5,5-dimethyl-1-cyclohexen-1-yl)pent-4-en-1-one",56973-85-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00a4900c-6319-4840-8840-20fef3e5e6b3/documents/c80f1c06-29b4-40be-ada6-a495b37f2837_385932a6-fe44-4f1f-bf62-03073955519f.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, "(1R)-1-[(4R,4aR,8aS)-2,6-bis(3,4-dimethylphenyl)tetrahydro[1,3]dioxino[5,4-d][1,3]dioxin-4-yl]ethane-1,2-diol",135861-56-2,"In two acute oral toxicity studies, no mortality was noted following a single oral administration of the substance at 5000 mg/kg bw. Body weight gains were not affected by treatment, and no abnormality was noted at necropsy. The only clinical sign of toxicity was soft stools in two females on day of treatment in Glaza (1992) study.In an acute dermal study conducted according to OECD guideline 402, the estimated dermal LD50 values for male and female rats were determined to be greater than 2000 mg/kg bw following a single cutaneous application at 2000 mg/kg bw. All animals appeared normal and exhibited body weight gain throughout the study. The gross necropsy examinations at termination revealed no macroscopic findings that could be associated with treatment.An acute inhalation has been waived and does not need be conducted because the test substance has very low vapor pressure (Vp = 1.23 x 10E-6 Pa at 25 °C) and high melting point (261 - 265 °C), so the potential for the generation of inhalable forms is very low. Further, the particle size distribution shows that proportions of inhalable, thoracic and especially respirable fractions are relatively small: proportion of test material having an inhalable particle size less than 100µm is (13.2%); proportion of test material having a thoracic particle size less than 10.2µm (9.72%); proportion of test material having a respirable particle size less than 5.4µm (1.40%). Reliable data on actue toxicity is available for the oral (LD50 > 5000 mg/kg bw) and dermal route (LD50 > 2000 mg/kg bw ), where the substance was clearly not toxic. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4ac924a-bdd8-4652-83a5-a33674f7121e/documents/IUC5-11a11040-82d8-4758-99f6-f9e968874191_5d9e25b2-131d-4ee7-8c18-48897025618b.html,,,,,, "D-Glucitol, 1-deoxy-1-(dimethylamino)-",76326-99-3," The registration substance, N, N-Dimethyl-D-glucamine, was evaluated to determine the toxic potential when administered for a period of 28 consecutive days repeatedly by oral (gavage) route to Sprague Dawley rats. This study provides information on any major toxic effects, target organs, possibility of cumulative effects and also to assess the reversibility of effects after 14 days recovery period and to estimate the No Observed Adverse Effect Level (NOAEL). A total of 60 (30 males + 30 females) Sprague Dawley rats were distributed to main and recovery groups. Each main group and recovery group consisted of 5 males and 5 females. The animals were administered N, N-Dimethyl-D-Glucamine at the dose levels of 0, 100, 300 and 1000 mg/kg/day. The vehicle and test item formulations were administered at the dose volume of 10 mL/kg body weight. The concentration analysis of the prepared dose formulations was performed on week 1 and week 4 of the experiment as per the validated method. The results of the analysed formulations were within the range of 90 to 110% of the nominal concentration and the relative standard deviation (% RSD) is equal to or less than 10.0%. All animals were observed for clinical signs, mortality and morbidity, detailed clinical examination, body weight and feed consumption. Ophthalmological examination and neurological/functional examination was carried out during week 4 for main groups and during week 6 for recovery groups. Haematology, clinical chemistry analysis, urinalysis, gross pathology and organ weighing were performed on day 29 for main groups and on day 43 for recovery groups. Histopathological examination was conducted on the tissues from the vehicle control and high dose group animals. The animals did not reveal any clinical signs of toxicity throughout the treatment and recovery period. No mortality or morbidity was observed throughout the experimental period. No treatment related changes in body weight, percent change in body weight, feed consumption, ophthalmoscopic examination, neurological/functional examination, haematology, clinical chemistry, urinalysis, organ weights (both absolute and relative) were observed. There were no gross pathological changes observed at any of the doses tested in either sex. No treatment related histopathological findings were noticed. The NOAEL of 1000 mg/kg/day was obtained. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8b5c6a0-f736-4d37-bdfb-242b9be8fe22/documents/e6d1bdf6-829c-4c46-97e6-50a0bda77356_708de0b2-ce31-4920-8742-ad9b262037b8.html,,,,,, "D-Glucitol, 1-deoxy-1-(dimethylamino)-",76326-99-3, The registration substance is of low acute and dermal toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8b5c6a0-f736-4d37-bdfb-242b9be8fe22/documents/ed8da0cb-c7da-470f-a7b9-8ce9a9870379_708de0b2-ce31-4920-8742-ad9b262037b8.html,,,,,, "D-Glucitol, 1-deoxy-1-(dimethylamino)-",76326-99-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8b5c6a0-f736-4d37-bdfb-242b9be8fe22/documents/ed8da0cb-c7da-470f-a7b9-8ce9a9870379_708de0b2-ce31-4920-8742-ad9b262037b8.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "D-Glucitol, 1-deoxy-1-(dimethylamino)-",76326-99-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8b5c6a0-f736-4d37-bdfb-242b9be8fe22/documents/ed8da0cb-c7da-470f-a7b9-8ce9a9870379_708de0b2-ce31-4920-8742-ad9b262037b8.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,4-dimethoxybenzene",150-78-7,LD50 range by oral route: 3600 - 8500 mg/kg. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7437f4b5-8060-435a-9b60-b1b0a236999d/documents/IUC5-17efc0c4-3f07-43e6-83f2-7ebb86295484_de08fa7d-7891-4829-b81f-9c4f04898a8e.html,,,,,, "4-hydroxy-2,5-dimethylfuran-2(3H)-one",3658-77-3," Subchronic toxicity study (oral) (similar to OECD TG 408, range-finding study for a 2 -year carcinogenicity study, GLP, K, Rel.1): NOAEL = 400 mg/kg bw/day (corresponding to actual doses of 386.0 mg kg bw in male rats and 391.4mg kg bw in female rats). No adverse effect reported at the highest dose level tested in this study. Carcinogenicity study (chronic) (OECD 451, GLP, K, Rel.1): LOAEL = 400 mg/kg bw/day (corresponding to actual doses of 388.85 mg/kg bw/day in males and 389.28 mg/kg bw/day in females),based on reduced body weight gains in males and females at 400 mg/kg bw/day and decreased survival in males at 400 mg/kg bw/day. NOEL = 200 mg/kg bw/day (corresponding to actual doses of 194.25 mg/kg bw/day in males and 195.90 mg/kg bw/day in females) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fe7a20e-9958-400b-a320-d263aa36526b/documents/27b6580c-9017-4100-b86a-3b1b2a735c83_d3aa3ab9-2a9a-4257-b9c6-e86c043dc2fd.html,,,,,, "4-hydroxy-2,5-dimethylfuran-2(3H)-one",3658-77-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fe7a20e-9958-400b-a320-d263aa36526b/documents/27b6580c-9017-4100-b86a-3b1b2a735c83_d3aa3ab9-2a9a-4257-b9c6-e86c043dc2fd.html,Chronic toxicity – systemic effects,oral,NOAEL,194.25 mg/kg bw/day,,rat "4-hydroxy-2,5-dimethylfuran-2(3H)-one",3658-77-3," Acute toxicity oral: LD50 < 2000 mg/kg bw (WoE, eq. OECD 401 in rats, non-GLP, rel.2 & study in mice, non-OECD, non GLP, rel.4) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fe7a20e-9958-400b-a320-d263aa36526b/documents/92021ea0-5a06-4f43-b96c-4e62e4193026_d3aa3ab9-2a9a-4257-b9c6-e86c043dc2fd.html,,,,,, "4-hydroxy-2,5-dimethylfuran-2(3H)-one",3658-77-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fe7a20e-9958-400b-a320-d263aa36526b/documents/92021ea0-5a06-4f43-b96c-4e62e4193026_d3aa3ab9-2a9a-4257-b9c6-e86c043dc2fd.html,,oral,LD50,"1,608 mg/kg bw",adverse effect observed, "3,4-dihydro-6-hydroxy-7-methoxy-2,2-dimethyl-1(2H)-benzopyran",83923-51-7,"Key study: Test method according to OECD TG 423, GLP study. The LD50 cut off value for the test item was determined to be 5000 mg/kg body weight when administered as a single dose by oral gavage to female Sprague Dawley rat. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29190f48-2dc2-4bf6-b73e-afece6b6b934/documents/1eff0565-b3d5-4dad-a3c4-2e777ca0c370_4a26be99-9bf5-41e3-9ac0-2fb6ce5df6b0.html,,,,,, "3,4-dihydro-6-hydroxy-7-methoxy-2,2-dimethyl-1(2H)-benzopyran",83923-51-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29190f48-2dc2-4bf6-b73e-afece6b6b934/documents/1eff0565-b3d5-4dad-a3c4-2e777ca0c370_4a26be99-9bf5-41e3-9ac0-2fb6ce5df6b0.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, (ethylenedioxy)dimethanol,3586-55-8," The LD50(rat, oral) was determined to be between 200 and 2000 mg/kg for males and females. The LD50(rat, dermal) was determined to be > 2000 mg/kg for males and females. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aea1079-c5c2-48c9-8bd3-6b8cfba37648/documents/4d826cac-7b12-468c-8403-52a1d24cb3d5_d7a1aefe-09c9-439e-a80c-723483c84c7c.html,,,,,, "1,3-bis(hydroxymethyl)urea",140-95-4," Oral: In an in vivo acute oral toxicity study in rats (Acute-Toxic-Class Method = ATC-Method) according to OECD Guideline 423, a LD50 > 2000 mg/kg bw was determined (UN GHS: No Category) (reference 7.2.1-1). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33d90e14-a7ce-475b-a575-1ba22fffdbae/documents/92bc7334-251f-4764-a6d0-61af36d96385_d6b78e9e-943a-4e16-bcb3-9f6fcc4d3336.html,,,,,, "1,3-bis(hydroxymethyl)urea",140-95-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33d90e14-a7ce-475b-a575-1ba22fffdbae/documents/92bc7334-251f-4764-a6d0-61af36d96385_d6b78e9e-943a-4e16-bcb3-9f6fcc4d3336.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,2-bis(hydroxymethyl)butanoic acid",10097-02-6,"To evaluate the toxicity of the test substance a subacute study in rats by oral route was performed. The study was conducted in accordance with B.7 92/69/EEC of July 31, 1992. The test substance was administered orally via gavage to groups of 6 male and 6 female Crj:CD (SD) IGS rats using target doses of 0, 8, 40, 200 and 1000 mg/kg bw/d for 4 weeks. Based oh the results of the study, 1000 mg/kg bw/d was established as the no-observed-adverse-effect-level (NOAEL) and 200 mg/kg bw/d the no-observed-effect-level (NOEL) for male and female rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2bbe074-bc49-4e86-b62d-bdcf4bf870bb/documents/d3e8a6c5-4ee7-4b2e-bafa-a41dfcf9ed82_b3d16b58-fd74-4560-a644-bb59fd81ab11.html,,,,,, "2,2-bis(hydroxymethyl)butanoic acid",10097-02-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2bbe074-bc49-4e86-b62d-bdcf4bf870bb/documents/d3e8a6c5-4ee7-4b2e-bafa-a41dfcf9ed82_b3d16b58-fd74-4560-a644-bb59fd81ab11.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2-bis(hydroxymethyl)butanoic acid",10097-02-6,"Acute oral Performed according to EU Method B.1 (Acute Toxicity (Oral)) guideline and in compliance with GLP, Groups (5/sex/dose) of CD rats of Sprague-Dawley origin (Hsd:Sprague-Dawley(CD)) were given a single oral (gavage) dose of DMBA at 2000 mg/kg bw. Animals were then observed for mortality, clinical signs and bodyweights for 14 days. No mortality was observed. Clinical signs of reaction to treatment comprised piloerection, hunched posture (in all animals), soft to liquid faeces (in all males and three females) and increased salivation (in one female). There were no other signs of reaction to treatment and recovery was complete in all rats by Day 8. All animals were considered to have achieved satisfactory bodyweight gains throughout the study. No abnormalities were observed at the study termination necropsy. In this study, the combined oral LD50 of DMBA was considered to be higher than 2000 mg/kg bw in rats. Under the test conditions, the oral LD50 for DMBA is higher than 2000 mg/kg bw in rats therefore it is not classified according to the CLP Regulation (EC) N° (1272-2008).   Acute inhalation toxicity The first acute inhalation toxicity study with 2,2-bis(hydroxymethyl)butanoic acid was carried out in accordance to the OECD Guideline 436: Acute inhalation toxicity – Acute toxic class method (2009) in GLP conditions. The study was performed with 3 males and 3 females of rats (Rattus norvegicus, strain Wistar) for each tested group. Concentration of test material in air (vehicle) was: nominal concentration = 4.5 mg/L (Group 1) and 9.6 mg/L (Group 2) , achieved mean concentration (measured in breathing zone using gravimetric and analytical techniques was 1.11 mg/L or 24.7 % of output (Group 1) and 3.67 mg/L or 38.2 % of output (Group 2).Type of inhalation exposure was Head-Nose only and the animals were adapted to the exposure tubes for 5 days with gradually increased time to a total duration of 4 hours by the fifth day.All the rats were observed for mortality and clinical signs during exposure and daily during the subsequent 14-day post-exposure periodThe maximal cut-off value of exposure concentration 5 mg/L was failed to reach achieving a respirable particle size (MMAD = 1-4 μm). For Group 2, exposure was performed with a feasible concentration of 3.67 ± 0.51 mg/L with a maximal analytical value of 4.6 mg/L for one sample.There were no animal’s morbidity and mortality on 1.11 ± 0.25 mg/L and 3.67 ± 0.51 mg/L exposure. Clinical signs in some animals treated with lower and higher concentrations were observed 24-48 hours after exposure and considered to be caused by the irritative effect of the test item. The total weight gain in all animals was positive, except for one female in group 1, which showed a fall in body weight on the last day of the study for an unclear reason. No gross findings were revealed during necropsy.Based on effects on the maximal feasible concentration 3.67 ± 0.51 mg/L that was lower than the cut-off value 5 mg/L, the acute inhalation LC50 in rats is considered to be more than 5 mg/L. The second acute inhalation toxicity study with the test item (DMBA)  was carried out in accordance to the OECD Guideline 403: Acute inhalation toxicity (2009) in GLP conditions. The concentration level was used in this limit test corresponds to the maximum feasible concentration achieved previously by generating dust aerosol from a pelletized substance under a 12 bar pressure scraped off in a dust generator at a speed of 0.1 mm/min and Flow application 15 L/min, Flow air 5 L/min. At the same conditions, but with the lower relative humidity in the inhalation chamber, the mean feasible concentration of exposure was 3.2 mg/L.There were no animal’s morbidity and mortality and significant clinical signs on this concentration; the total weight gain in all animals was positive. The decrease in body temperature and respiration rate 24-48 hours after exposure was reversible. No gross findings were revealed during necropsy two weeks after exposure and no test item related microscopic findings were found in the nasal cavity, nasopharynx, paranasal sinus, larynx, trachea and lungs.Based on effects on the maximal feasible concentration 3.2 ± 0.4 mg/L and 3.2 ± 0.3 mg/L (for males and females), the acute inhalation LC50 in rats is considered to be more than cut-off value 5 mg/L.     Acute dermal toxicity   The test of acute dermal toxicity to the rat (strain Wistar) for DMBA was performed as a limit test according to 92/69/EWG, B.3 (OECD 402) under GLP condition.  5 females and 5 males of rats were exposed with semiocclusive type of coverage to dose of 2000 mg/kg bw for 24 hours. Results: No mortalities occurred and no clinical symptoms were observed. The body weight gain was within the range commonly recorded for animals of this strain and age. No effects to the organs were observed. Only slight scaling of the treated skin was observed in one male and two females, which persisted in two animals (one female and one male) until day 11 and in one female animal until day 12 of the observation period. The LD50 was established as more than 2000 mg/kg bw. (LD 50 > 2000 mg/kg bw). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2bbe074-bc49-4e86-b62d-bdcf4bf870bb/documents/IUC5-bc9de2ee-91db-4833-ac0e-149fb64aeea3_b3d16b58-fd74-4560-a644-bb59fd81ab11.html,,,,,, "2,2-bis(hydroxymethyl)butanoic acid",10097-02-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2bbe074-bc49-4e86-b62d-bdcf4bf870bb/documents/IUC5-bc9de2ee-91db-4833-ac0e-149fb64aeea3_b3d16b58-fd74-4560-a644-bb59fd81ab11.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,2-bis(hydroxymethyl)butanoic acid",10097-02-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2bbe074-bc49-4e86-b62d-bdcf4bf870bb/documents/IUC5-bc9de2ee-91db-4833-ac0e-149fb64aeea3_b3d16b58-fd74-4560-a644-bb59fd81ab11.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,2-bis(hydroxymethyl)butanoic acid",10097-02-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2bbe074-bc49-4e86-b62d-bdcf4bf870bb/documents/IUC5-bc9de2ee-91db-4833-ac0e-149fb64aeea3_b3d16b58-fd74-4560-a644-bb59fd81ab11.html,,inhalation,LC50,> 5 mg/L,no adverse effect observed, "Cyclohex-1,4-ylenedimethanol",105-08-8," In a subchronic oral toxicity study, 1,4-cyclohexanedimethanol was administered via the drinking water to groups of male and female Crl:CD(SD)IGS BR rats (10 females/dose and 12 males/dose) at target concentrations of 0 (0 mg/mL), 0.4% (4.0 mg/mL), 0.8% (8.0 mg/mL), and 1.25% (12.5 mg/mL) for 13 weeks. One male rat each from the low- and high-dose groups were found dead or euthanized in extremis before study termination. Clinical abnormalities related to test substance exposure included minimal to severe hematuria and/or brown/red discoloration of the urine, primarily in high-dose group animals. Softened or reduced feces occurred in animals in all groups but severity and incidence were slightly greater among treated groups. Other abnormal signs were observed occasionally in a few treated animals. During functional observational battery testing, significantly higher incidences of “possibly bloodstained” urine were observed for the high-dose animals at various times throughout the study; no other treatment-related changes were detected during the FOB assessment and there were no effects on motor activity. Reductions in mean body weights, body weight gains, and/or feed consumption values were seen in high-dose animals; there were no treatment-related effects on water consumption in any group. Moderate to large amounts of blood were detected in the urine of both sexes, primarily in the high-dose groups. Protein urinary concentrations were slightly increased in the high-dose animals and a dose-dependent decrease in urinary pH was observed in both sexes. No treatment-related changes in clinical chemistry, hematology, or cell morphology were observed. Organ weight changes were limited to statistically significantly lower mean absolute heart weights for high-dose males and lower mean terminal body weights and absolute thymus weights in high-dose females. Increases in a number of mean relative organ weights in high-dose females were considered related to the reduced terminal body weight changes and were not considered toxicologically significant. No toxicologically significant gross or microscopic lesions were observed at necropsy for any of the treated groups. Under the conditions of this study, the NOEL following exposure to 1,4-cyclohexanedimethanol in the drinking water for 13 weeks was 0.8% (resulting in doses of 479 mg/kg bw/day for male rats and 754 mg/kg bw/day for female rats). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a723a24-9850-4027-aab6-fdc34d6ae936/documents/IUC5-f3ce88bf-4425-4577-8b9c-98064a095bb3_867c8479-1dcd-4b99-9b7b-443ab2590e5f.html,,,,,, "Cyclohex-1,4-ylenedimethanol",105-08-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a723a24-9850-4027-aab6-fdc34d6ae936/documents/IUC5-f3ce88bf-4425-4577-8b9c-98064a095bb3_867c8479-1dcd-4b99-9b7b-443ab2590e5f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,754 mg/kg bw/day,,rat "Cyclohex-1,4-ylenedimethanol",105-08-8, An acute oral toxicity study showed the rat LD50 was > 2000 mg/kg. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a723a24-9850-4027-aab6-fdc34d6ae936/documents/IUC5-484e311f-e338-48f9-9e02-63e375057675_867c8479-1dcd-4b99-9b7b-443ab2590e5f.html,,,,,, "Cyclohex-1,4-ylenedimethanol",105-08-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a723a24-9850-4027-aab6-fdc34d6ae936/documents/IUC5-484e311f-e338-48f9-9e02-63e375057675_867c8479-1dcd-4b99-9b7b-443ab2590e5f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Cyclohex-1,4-ylenedimethanol",105-08-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a723a24-9850-4027-aab6-fdc34d6ae936/documents/IUC5-484e311f-e338-48f9-9e02-63e375057675_867c8479-1dcd-4b99-9b7b-443ab2590e5f.html,,inhalation,LC50,"1,250 mg/m3",no adverse effect observed, "2,2-bis(hydroxymethyl)propionic acid",4767-03-7,"A modern 90-day rat study performed with the substance reports a NOAEL of 1000 mg/kg bw/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A high-quality 90-day rat study is available for the substance ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdafc2c4-8302-4e32-8e3b-f6830554c0ba/documents/be5e04d3-a44f-4506-a08d-e24da338ded0_198bce39-a477-43b9-948b-22f577946d07.html,,,,,, "2,2-bis(hydroxymethyl)propionic acid",4767-03-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdafc2c4-8302-4e32-8e3b-f6830554c0ba/documents/be5e04d3-a44f-4506-a08d-e24da338ded0_198bce39-a477-43b9-948b-22f577946d07.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2-bis(hydroxymethyl)propionic acid",4767-03-7,"The acute oral LD50 of Bis-MPA (dimethylolpropionic acid) in rats is >2000 mg/kg bw. The acute dermal LD50 of Bis-MPA (dimethylolpropionic acid) in rats in >2000 mg/kg bw. A waiver is proposed for acute inhalation toxicity. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): A modern GLP and guideline-compliant acute oral toxicity study is available for the substance Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): A modern GLP and guideline-compliant acute dermal toxicity study is available for the substance. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdafc2c4-8302-4e32-8e3b-f6830554c0ba/documents/5edd6505-6ebd-4845-8d05-62c5c2cf1b32_198bce39-a477-43b9-948b-22f577946d07.html,,,,,, "2,2-bis(hydroxymethyl)propionic acid",4767-03-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdafc2c4-8302-4e32-8e3b-f6830554c0ba/documents/5edd6505-6ebd-4845-8d05-62c5c2cf1b32_198bce39-a477-43b9-948b-22f577946d07.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,2-bis(hydroxymethyl)propionic acid",4767-03-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdafc2c4-8302-4e32-8e3b-f6830554c0ba/documents/5edd6505-6ebd-4845-8d05-62c5c2cf1b32_198bce39-a477-43b9-948b-22f577946d07.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-phenylpropan-2-ol,617-94-7, Oral: No valid studies are available. The available studies get a K4 since no original references are available only secondary references. Since only secondary references are available the data is not sufficient for C&L purposes. This substance is a transported isolated intermediate and therefore no additional testing is warranted. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dcf6b9cd-f871-4e84-a24a-35792f9d15d8/documents/IUC5-ae1662b6-b088-425a-af2f-98660b6d2216_c0534357-3ec9-45a1-bd46-791f78132b80.html,,,,,, 2-phenylpropan-2-ol,617-94-7," Oral:  WoE: The available LD50s range from ± 1000 – 3000 mg/kg bw. Inhalation: No valid studies are available. The available study gets a K4 since no original references are available only secondary references. No LD50 is available, no LD50 available, data is not sufficient for C&L purposes. This substance is a transported isolated intermediate and therefore no additional testing is warranted. Dermal: No valid studies are available. The available study gets a K4 since no original references are available only secondary references. The available LD50 is 4300 mg/kg bw. Since only one secondary reference is available the data is not sufficient for C&L purposes. This substance is a transported isolated intermediate and therefore no additional testing is warranted. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcf6b9cd-f871-4e84-a24a-35792f9d15d8/documents/IUC5-94b94db3-7e3c-46dd-ac85-b679ccf05865_c0534357-3ec9-45a1-bd46-791f78132b80.html,,,,,, "N,N-dimethyl-p-toluidine",99-97-8,Repeated Dose toxicity: Oral Chronic toxicity study (rats: oral gavage) (Key Study): LOAEL was considered to be 6 mg/kg body weight /day when male and female rats were treated with test chemical orally.   ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c188325c-8d20-4253-bdde-3795cd11240d/documents/8f29c0b5-1209-415f-b2f2-c0351aa61d26_c6b74b04-62c0-4e89-b424-21c51636d1bd.html,,,,,, "N,N-dimethyl-p-toluidine",99-97-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c188325c-8d20-4253-bdde-3795cd11240d/documents/8f29c0b5-1209-415f-b2f2-c0351aa61d26_c6b74b04-62c0-4e89-b424-21c51636d1bd.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,19.1 mg/m3,,rat "N,N-dimethyl-p-toluidine",99-97-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c188325c-8d20-4253-bdde-3795cd11240d/documents/8f29c0b5-1209-415f-b2f2-c0351aa61d26_c6b74b04-62c0-4e89-b424-21c51636d1bd.html,Chronic toxicity – systemic effects,oral,LOAEL,6 mg/kg bw/day,,rat "N,N-dimethyl-p-toluidine",99-97-8,"Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the given test chemical. The LD50 value is 1650 mg/kg bw. The study concluded that the LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity.   Acute Inhalation Toxicity: The acute inhalation toxicity dose (LC50) was considered based on study conducted on rats for the given test chemical. The LC50 value is 1400 mg/m3 (1.4 mg/L). The study concluded that the LC50 value is between 1.0-5.0 mg/L, for acute inhalation toxicity. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified in “Category 2” for acute inhalation toxicity.   Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on study conducted on rabbts for the test chemical. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c188325c-8d20-4253-bdde-3795cd11240d/documents/bd22ffa8-d0f0-4d11-94fd-1405586123f2_c6b74b04-62c0-4e89-b424-21c51636d1bd.html,,,,,, "N,N-dimethyl-p-toluidine",99-97-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c188325c-8d20-4253-bdde-3795cd11240d/documents/bd22ffa8-d0f0-4d11-94fd-1405586123f2_c6b74b04-62c0-4e89-b424-21c51636d1bd.html,,oral,LD50,"1,650 mg/kg bw",adverse effect observed, "N,N-dimethyl-p-toluidine",99-97-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c188325c-8d20-4253-bdde-3795cd11240d/documents/bd22ffa8-d0f0-4d11-94fd-1405586123f2_c6b74b04-62c0-4e89-b424-21c51636d1bd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N-dimethyl-p-toluidine",99-97-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c188325c-8d20-4253-bdde-3795cd11240d/documents/bd22ffa8-d0f0-4d11-94fd-1405586123f2_c6b74b04-62c0-4e89-b424-21c51636d1bd.html,,inhalation,LC50,"1,400 mg/m3",adverse effect observed, "Dodecanedioic acid, 1,12-bis(2-octyldodecyl) ester",129423-55-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f34bb49-ed14-4894-9e0a-9049f4e3b836/documents/8d8d582a-c790-46e2-8bb4-2dd1dfb3b265_1373bb81-31a9-4771-9753-2712f7a4a7de.html,,oral,discriminating dose,> 20 ,adverse effect observed, "5,7-dihydroxy-2-(3-hydroxy-4-methoxyphenyl)-4-benzopyrone",520-34-3," Acute toxicity: oral. Weight of evidence. Based on the read across approach from two analogue substances, the LD50 of the test item is not acutely toxic, with an LD50 greater than 4934 mg/kg bw in mice (worst case). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6bf0bcd-ad3d-4e39-979e-e6aba163620e/documents/70e5f5c7-5e54-434d-acea-018afba846f0_7c92e5a4-36c1-46ed-a0e6-28faa5b5e1ac.html,,,,,, "5,7-dihydroxy-2-(3-hydroxy-4-methoxyphenyl)-4-benzopyrone",520-34-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6bf0bcd-ad3d-4e39-979e-e6aba163620e/documents/70e5f5c7-5e54-434d-acea-018afba846f0_7c92e5a4-36c1-46ed-a0e6-28faa5b5e1ac.html,,oral,LD50,"4,934 mg/kg bw",no adverse effect observed, trans-1-(1-oxohexadecyl)-4-[(1-oxohexadecyl)oxy]-L-proline,41672-81-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bce619c0-cad5-42aa-939b-6e1da4bb15fa/documents/d385376b-e8ca-44a8-b065-24aceaf6139b_96e2be06-fedd-4a6c-a4ab-e668cade6da8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat trans-1-(1-oxohexadecyl)-4-[(1-oxohexadecyl)oxy]-L-proline,41672-81-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bce619c0-cad5-42aa-939b-6e1da4bb15fa/documents/a762362d-f4f5-453b-93cd-95114e8d31c6_96e2be06-fedd-4a6c-a4ab-e668cade6da8.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, trans-1-(1-oxohexadecyl)-4-[(1-oxohexadecyl)oxy]-L-proline,41672-81-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bce619c0-cad5-42aa-939b-6e1da4bb15fa/documents/a762362d-f4f5-453b-93cd-95114e8d31c6_96e2be06-fedd-4a6c-a4ab-e668cade6da8.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Dimethylbis[2-[(1-oxohexadecyl)oxy]ethyl]ammonium chloride,97158-31-1, rat oral LD50 > 2000 mg/kg dermal: data waiving ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ae451b0-7019-4262-811f-fab66fe07941/documents/c64c3424-5cb5-4d49-a7fa-f6dbae650ff9_f8ef74c7-2fc7-449a-9aae-c7bd7da03ba8.html,,,,,, Dimethylbis[2-[(1-oxohexadecyl)oxy]ethyl]ammonium chloride,97158-31-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ae451b0-7019-4262-811f-fab66fe07941/documents/c64c3424-5cb5-4d49-a7fa-f6dbae650ff9_f8ef74c7-2fc7-449a-9aae-c7bd7da03ba8.html,,oral,LD50,"2,000 ",no adverse effect observed, "Fatty acids, C5-9, hexaesters with dipentaerythritol",67762-52-1,"Repeated dose toxicity: Oral NOAEL (rat, m/f): 1000 mg/kg bw/day (OECD 408, GLP analogue approach) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b8945818-51a0-4ef4-bbcd-38b8ee5716c7/documents/IUC5-a800659c-41dd-401a-b026-d148e7b74064_ed6239a8-a356-4768-a780-6cad5681bb11.html,,,,,, "Fatty acids, C5-9, hexaesters with dipentaerythritol",67762-52-1,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401, GLP)Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, GLP, analogue approach)Acute toxicity: Inhalation LC50 (rat, m/f): > 5.0 mg/L air (OECD 403, analogue approach) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8945818-51a0-4ef4-bbcd-38b8ee5716c7/documents/IUC5-bef17457-2e18-4e2a-bd4e-707318bf1266_ed6239a8-a356-4768-a780-6cad5681bb11.html,,,,,, "Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol",84418-63-3,"Repeated dose toxicity: Oral NOAEL (rat, m/f): >= 1000 mg/kg bw/day (OECD 407, GLP, analogue approach) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5fb7b1e2-a616-48c8-82cf-7a89476bc0ab/documents/IUC5-244ed419-f26d-40bc-b6d9-a170e2c4d261_27293557-5e02-428d-b8c8-c1b29af5c6ba.html,,,,,, "Isononanoic acid, mixed esters with dipentaerythritol, heptanoic acid and pentaerythritol",84418-63-3,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401, GLP, analogue approach)Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, GLP, analogue approach)Acute toxicity: Inhalation LC50 (rat, m/f): > 5.0 mg/L air (OECD 403, analogue approach) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fb7b1e2-a616-48c8-82cf-7a89476bc0ab/documents/IUC5-702dac54-58d9-4b20-a8db-2bd275b65be7_27293557-5e02-428d-b8c8-c1b29af5c6ba.html,,,,,, Diphenyl ether,101-84-8,"Oral: 13-week dietary study in rats was conducted according to OECD Guideline 408Dermal: 13-week dermal study was conducted in rats. No information on guidelines; however, the study was published in a peer reviewed journal in 2003.Inhalation: Repeated inhalation exposures were conducted in rats, rabbits and dogs 7 hours per day, 5 days per week for a total of 20 exposures. Study was conducted prior to guidelines and published in a peer reviewed journal. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d3ad062-1657-4cc7-adf0-d647f17048c2/documents/IUC5-ec56fccc-3bd0-4d11-914e-73dd04b25bb5_48ca265f-28fc-4d6b-8c1c-d91a45e38a7c.html,,,,,, Diphenyl ether,101-84-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d3ad062-1657-4cc7-adf0-d647f17048c2/documents/IUC5-ec56fccc-3bd0-4d11-914e-73dd04b25bb5_48ca265f-28fc-4d6b-8c1c-d91a45e38a7c.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,139 mg/m3,,rat Diphenyl ether,101-84-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d3ad062-1657-4cc7-adf0-d647f17048c2/documents/IUC5-ec56fccc-3bd0-4d11-914e-73dd04b25bb5_48ca265f-28fc-4d6b-8c1c-d91a45e38a7c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,301 mg/kg bw/day,,rat Diphenyl ether,101-84-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d3ad062-1657-4cc7-adf0-d647f17048c2/documents/IUC5-ec56fccc-3bd0-4d11-914e-73dd04b25bb5_48ca265f-28fc-4d6b-8c1c-d91a45e38a7c.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat Diphenyl ether,101-84-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d3ad062-1657-4cc7-adf0-d647f17048c2/documents/IUC5-ec56fccc-3bd0-4d11-914e-73dd04b25bb5_48ca265f-28fc-4d6b-8c1c-d91a45e38a7c.html,Repeated dose toxicity – local effects,dermal,NOAEL,2.5 mg/cm2,no adverse effect observed,rat Diphenyl ether,101-84-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d3ad062-1657-4cc7-adf0-d647f17048c2/documents/IUC5-ec56fccc-3bd0-4d11-914e-73dd04b25bb5_48ca265f-28fc-4d6b-8c1c-d91a45e38a7c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,35 mg/m3,adverse effect observed,rat Diphenyl ether,101-84-8,Oral studies follow a standard acute method or are equivalent or similar to OECD 401. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d3ad062-1657-4cc7-adf0-d647f17048c2/documents/IUC5-35f4af47-b35d-402a-ad41-249efd4acebc_48ca265f-28fc-4d6b-8c1c-d91a45e38a7c.html,,,,,, Diphenyl ether,101-84-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d3ad062-1657-4cc7-adf0-d647f17048c2/documents/IUC5-35f4af47-b35d-402a-ad41-249efd4acebc_48ca265f-28fc-4d6b-8c1c-d91a45e38a7c.html,,oral,LD50,"2,830 mg/kg bw",no adverse effect observed, Diphenyl ether,101-84-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d3ad062-1657-4cc7-adf0-d647f17048c2/documents/IUC5-35f4af47-b35d-402a-ad41-249efd4acebc_48ca265f-28fc-4d6b-8c1c-d91a45e38a7c.html,,dermal,LD50,"7,940 mg/kg bw",no adverse effect observed, Dipotassium dihydrogen ethylenediaminetetraacetate,2001-94-7," An acute oral toxicity study has not been conducted on K2EDTA. However, the acute oral LD50 of edetic acid in rats was found to be 4500 mg/kg bw (BASF 1973). K2EDTA is not acutely toxic via the inhalation route. In a OECD 403 guideline compliant acute inhalation study in F344 rats, acute exposure to K2EDTA for 4hours resulted in an LC50 of >5.80mg/L. Furthermore it is highly unlikely that K2EDTA would be acutely toxic via the dermal route as K salts of EDTA are unable to penetrate the skin with data generated in humans indicating 0.001% of the total dose is absorbed. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cba6f1c5-d75d-48d4-adb8-a2730ed33f03/documents/8156d63c-b7d1-4738-935d-3dea93fc2fb3_1d942ff3-f918-4c89-80df-e6826d5bacd5.html,,,,,, Dipotassium dihydrogen ethylenediaminetetraacetate,2001-94-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cba6f1c5-d75d-48d4-adb8-a2730ed33f03/documents/8156d63c-b7d1-4738-935d-3dea93fc2fb3_1d942ff3-f918-4c89-80df-e6826d5bacd5.html,,oral,LD50,"4,500 mg/kg bw",, Dipotassium dihydrogen ethylenediaminetetraacetate,2001-94-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cba6f1c5-d75d-48d4-adb8-a2730ed33f03/documents/8156d63c-b7d1-4738-935d-3dea93fc2fb3_1d942ff3-f918-4c89-80df-e6826d5bacd5.html,,inhalation,LC50,5.8 ,no adverse effect observed, Dipotassium oxalate,583-52-8," Oral (no guideline followed), rat: LD50 = 375 mg/kg bw (female) (RA from CAS 144-62-7) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b06d27f-c45d-42ce-b6ca-22e6af989eec/documents/abfebba6-c7ef-48a2-ab34-4ed053bbcbb1_e5e38379-344e-44b1-9afd-f875580fb79f.html,,,,,, Dipotassium oxalate,583-52-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b06d27f-c45d-42ce-b6ca-22e6af989eec/documents/abfebba6-c7ef-48a2-ab34-4ed053bbcbb1_e5e38379-344e-44b1-9afd-f875580fb79f.html,,oral,LD50,375 mg/kg bw,no adverse effect observed, Dipotassium hydrogenorthophosphate,7758-11-4,"The key information has been provided on the analogous substance sodium aluminium phosphate. The key study (Matalski K, 1972b) has been selected as the most reliable or appropriate study for use in the derivation of DNELS. Data exists for dipotassium hydrogenorthophosphate (Shim, 2005), however as the study is only a 28-day study and in accordance with Annex XI, Section 3.2 (a.ii) of Regulation (EC) N0. 1907/2006 (REACH) the data are not considered to be suitable for derivation of a DNEL as subchronic data are available. Additional supporting data provided are not considered to fulfil the guideline requirements for repeated dose toxicity (sub-chronic or chronic). Full justification for the choice of data and the rationale for read-across can be found below. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/459354ed-0e93-4d0b-91d3-f6af15f9481b/documents/IUC5-ae8e3796-2ebf-43cc-ba0d-0a69984c515a_69073c71-e8e8-4fd4-9fe3-17b3f1e78a72.html,,,,,, Dipotassium hydrogenorthophosphate,7758-11-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/459354ed-0e93-4d0b-91d3-f6af15f9481b/documents/IUC5-ae8e3796-2ebf-43cc-ba0d-0a69984c515a_69073c71-e8e8-4fd4-9fe3-17b3f1e78a72.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,322.88 mg/kg bw/day,,dog Dipotassium hydrogenorthophosphate,7758-11-4,"Acute oral toxicity: Five studies are available to assess the acute oral toxicity of dipotassium hydrogenorthophosphate. All studies indicate that dipotassium hydrogenorthophosphate has a low potential for systemic toxicity following acute administration via the oral route. The key study (Bradshaw J, 2010) has been conducted according to a current guideline (OECD 420) according to the principles of GLP. The acute oral median dose (LD50) of dipotassium hydrogenorthophosphate in the female Wistar strain rat was estimated to be > 2000 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP). Additional supporting data (Freeman C (1987) Blaszcak D (1986), Parke G (1975)) are considered to be sufficient to support the overall classification; however these studies are not sufficient as stand-alone data sources for this endpoint.Acute inhalation toxicity: One key study is available to assess the acute inhalation toxicity of the analogous substance sodium dihydrogenorthophosphate. The key study (Signorin J, 1993) has been conducted according to the relevant guidelines (EU and US) and according to the principles of GLP. The acute inhalation median concentration (LC50) in male and female rats was estimated to be > 0.83 mg/L (the maximum attainable concentration). It is therefore anticipated that dipotassium hydrogenorthophosphate is of equally low concern via the inhalation route (see below for justification).Acute dermal toxicity: One key study and a number of supporting studies are provided. All studies support no classification. The key study (Blaszcak D, 1986) estimated the LD50 of dipotassium hydrogenorthophosphate to be >5,000 mg /kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/459354ed-0e93-4d0b-91d3-f6af15f9481b/documents/IUC5-380c3d1e-1428-48de-90db-8284d91019d2_69073c71-e8e8-4fd4-9fe3-17b3f1e78a72.html,,,,,, Oxydipropanol,25265-71-8,"NTP drinking water studies with rats and mice of different exposure durations (14-day, 90-day and 2-year) were available for assessment. The main effects were found in liver and kidneys. Increased incidence and severity of chronic progressive nephropathy (CPN) and subsequent renal insufficiency was observed in male rats exposed to 10,000 and 40,000 ppm dipropylene glycol in drinking water in the 2-year study. However, as rodent CPN is believed not to have a strict counterpart in humans, these findings were considered to be irrelevant for human risk assessment. Based on the results of 2-year carcinogenicity study with rats, the NOAEL for repeated dose toxicity was established to correspond to 470 and 530 mg/kg bw/day for male and female rats, respectively (actual ingested dose), based on the bile duct hyperplasia and olfactory epithelium degeneration and/or atrophy. These values shall be used for the risk assessment and DNEL derivation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04a0664b-c087-4c56-9804-dc07c5d6e7fb/documents/IUC5-28699b60-783f-4b8c-93fc-31e770d50ff2_894d9b1f-e2f1-4d89-ad7f-a5b8234e226c.html,,,,,, Oxydipropanol,25265-71-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04a0664b-c087-4c56-9804-dc07c5d6e7fb/documents/IUC5-28699b60-783f-4b8c-93fc-31e770d50ff2_894d9b1f-e2f1-4d89-ad7f-a5b8234e226c.html,Chronic toxicity – systemic effects,oral,NOAEL,470 mg/kg bw/day,,rat Oxydipropanol,25265-71-8,"Dipropylene glycol has a low acute toxicity by oral, dermal and inhalation routes. In rats, LD50 value by oral route is > 5000 mg/kg bw. In the acute dermal toxicity study with rabbits, LD50 was > 5010 mg/kg bw. The classification for acute toxicity is not warranted based on these values. In the acute inhalation toxicity study with rats, LC50 value was > 2.34 mg/l/4h. The latter value is below the cut-off value of 5 mg/l/4 h, established for classification of aerosols in accordance to Directive 67/548/EEC. However, as higher concentration levels were not attainable and based on the absence of mortality and of any clinical signs of toxicity in the study, the classification of dipropylene glycol for acute inhalation toxicity is not warranted. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04a0664b-c087-4c56-9804-dc07c5d6e7fb/documents/IUC5-705b45f1-a0f3-424c-848f-4ee3431e522e_894d9b1f-e2f1-4d89-ad7f-a5b8234e226c.html,,,,,, Oxydipropanol,25265-71-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04a0664b-c087-4c56-9804-dc07c5d6e7fb/documents/IUC5-705b45f1-a0f3-424c-848f-4ee3431e522e_894d9b1f-e2f1-4d89-ad7f-a5b8234e226c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Oxydipropanol,25265-71-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04a0664b-c087-4c56-9804-dc07c5d6e7fb/documents/IUC5-705b45f1-a0f3-424c-848f-4ee3431e522e_894d9b1f-e2f1-4d89-ad7f-a5b8234e226c.html,,dermal,LD50,"5,010 mg/kg bw",no adverse effect observed, Oxydipropanol,25265-71-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04a0664b-c087-4c56-9804-dc07c5d6e7fb/documents/IUC5-705b45f1-a0f3-424c-848f-4ee3431e522e_894d9b1f-e2f1-4d89-ad7f-a5b8234e226c.html,,inhalation,LC50,"2,340 mg/m3",no adverse effect observed, Oxydipropyl dibenzoate,27138-31-4,"A 13 -week repeated oral dose (dietary) study (HLS 1999, VCL 232/971947, OECD & GLP) was conducted to determine the effects of prolonged exposure on rats of the test material DPGDB. Groups of ten rats were dosed by dietary administration with DPGDB for a period of 13 weeks at levels 0 (untreated diet control), 250, 1000, 1750, and 2500 mg/kgbw/day.DPGDB was found to be non-toxic orally under the conditions of this repeated dose toxicity test. The NOAEL was determined at 1000mg/kg/d. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d6b3ae2-c0d8-4aeb-bf7f-6b3b748812fd/documents/8caffe73-5723-4424-a102-9dec02776d51_db5eaa31-4926-4f73-8c3d-23281a70844e.html,,,,,, Oxydipropyl dibenzoate,27138-31-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d6b3ae2-c0d8-4aeb-bf7f-6b3b748812fd/documents/8caffe73-5723-4424-a102-9dec02776d51_db5eaa31-4926-4f73-8c3d-23281a70844e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Oxydipropyl dibenzoate,27138-31-4,"The results of the oral, dermal and inhalation studies indicate that DPGDB is not classified for acute toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d6b3ae2-c0d8-4aeb-bf7f-6b3b748812fd/documents/1398e602-518b-41c2-9a80-d299bc55451d_db5eaa31-4926-4f73-8c3d-23281a70844e.html,,,,,, Oxydipropyl dibenzoate,27138-31-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d6b3ae2-c0d8-4aeb-bf7f-6b3b748812fd/documents/1398e602-518b-41c2-9a80-d299bc55451d_db5eaa31-4926-4f73-8c3d-23281a70844e.html,,oral,LD50,"3,914 mg/kg bw",no adverse effect observed, Oxydipropyl dibenzoate,27138-31-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d6b3ae2-c0d8-4aeb-bf7f-6b3b748812fd/documents/1398e602-518b-41c2-9a80-d299bc55451d_db5eaa31-4926-4f73-8c3d-23281a70844e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Oxydipropyl dibenzoate,27138-31-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d6b3ae2-c0d8-4aeb-bf7f-6b3b748812fd/documents/1398e602-518b-41c2-9a80-d299bc55451d_db5eaa31-4926-4f73-8c3d-23281a70844e.html,,inhalation,LC50,"200,000 mg/m3",no adverse effect observed, "3,3'-iminodi(propylamine)",56-18-8,NOAEL (parental systemic toxicity): 15 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/696e2968-bdcd-425c-8d8e-bfba0859fa52/documents/IUC5-68fbf185-0d00-4fe3-ac61-5c3bc1ad3ad6_df0f7179-f3ff-4b43-bc1c-976702db7b5f.html,,,,,, "3,3'-iminodi(propylamine)",56-18-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/696e2968-bdcd-425c-8d8e-bfba0859fa52/documents/IUC5-68fbf185-0d00-4fe3-ac61-5c3bc1ad3ad6_df0f7179-f3ff-4b43-bc1c-976702db7b5f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "3,3'-iminodi(propylamine)",56-18-8,The oral LD50 was 700 mg/kg bw in rats.The inhal. LC50 was ca. 0.03 mg/L air.The dermal LD50 value falls between 200 and 400 mg/kg. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/696e2968-bdcd-425c-8d8e-bfba0859fa52/documents/IUC5-370ed2c3-3458-4d80-aa0c-b6827596c629_df0f7179-f3ff-4b43-bc1c-976702db7b5f.html,,,,,, "3,3'-iminodi(propylamine)",56-18-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/696e2968-bdcd-425c-8d8e-bfba0859fa52/documents/IUC5-370ed2c3-3458-4d80-aa0c-b6827596c629_df0f7179-f3ff-4b43-bc1c-976702db7b5f.html,,oral,LD50,700 mg/kg bw,adverse effect observed, "3,3'-iminodi(propylamine)",56-18-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/696e2968-bdcd-425c-8d8e-bfba0859fa52/documents/IUC5-370ed2c3-3458-4d80-aa0c-b6827596c629_df0f7179-f3ff-4b43-bc1c-976702db7b5f.html,,dermal,discriminating dose,200 mg/kg bw,adverse effect observed, "3,3'-iminodi(propylamine)",56-18-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/696e2968-bdcd-425c-8d8e-bfba0859fa52/documents/IUC5-370ed2c3-3458-4d80-aa0c-b6827596c629_df0f7179-f3ff-4b43-bc1c-976702db7b5f.html,,inhalation,LC50,30 mg/m3,adverse effect observed, "Balsams, gurjun",8030-55-5, Acute toxicity oral (OECD Guideline 401): LD50 > 5000 mg/kg Acute toxicity dermal (OECD Guideline 402): LD50 >5000 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fbcfe720-e08c-4e74-8771-63a9ad1e1894/documents/9b3c2851-6352-4e6f-b92a-a18c6a0fc931_ccacbadd-1074-41cd-82b9-8bb2ef15506f.html,,,,,, "Hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate]",2610-10-8,NOAEL > 1000 mg/kg bw/day at 30 days ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43718e88-5a48-422f-bfb0-361ba4290f62/documents/IUC5-c62e8f48-3d72-4b39-bae7-c7e8688135d5_fc71251e-072e-4aea-98f5-a0e4be61258b.html,,,,,, "Hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate]",2610-10-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43718e88-5a48-422f-bfb0-361ba4290f62/documents/IUC5-c62e8f48-3d72-4b39-bae7-c7e8688135d5_fc71251e-072e-4aea-98f5-a0e4be61258b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate]",2610-10-8,Oral toxicity: LD50 > 2000 mg/kg bwInhalation toxicity > 5 mg/m3Dermal toxicity: LD50 > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43718e88-5a48-422f-bfb0-361ba4290f62/documents/IUC5-aa21b6f4-2ad0-4af4-8541-c09e71b77a63_fc71251e-072e-4aea-98f5-a0e4be61258b.html,,,,,, "Hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate]",2610-10-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43718e88-5a48-422f-bfb0-361ba4290f62/documents/IUC5-aa21b6f4-2ad0-4af4-8541-c09e71b77a63_fc71251e-072e-4aea-98f5-a0e4be61258b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate]",2610-10-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43718e88-5a48-422f-bfb0-361ba4290f62/documents/IUC5-aa21b6f4-2ad0-4af4-8541-c09e71b77a63_fc71251e-072e-4aea-98f5-a0e4be61258b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hexasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[[2-sulphonato-4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate]",2610-10-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43718e88-5a48-422f-bfb0-361ba4290f62/documents/IUC5-aa21b6f4-2ad0-4af4-8541-c09e71b77a63_fc71251e-072e-4aea-98f5-a0e4be61258b.html,,inhalation,LC50,5 mg/m3,no adverse effect observed, Disodium 7-benzamido-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate,2610-11-9,NOAEL > 1000 mg/kg bw/day at 30 days ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c62ce255-806f-413f-8dcf-24ec691b7dcc/documents/IUC5-321b789a-084b-46c1-8f2b-050cea4ea14b_2bd934ef-2264-40ab-b027-dba948710576.html,,,,,, Disodium 7-benzamido-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate,2610-11-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c62ce255-806f-413f-8dcf-24ec691b7dcc/documents/IUC5-321b789a-084b-46c1-8f2b-050cea4ea14b_2bd934ef-2264-40ab-b027-dba948710576.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Disodium 7-benzamido-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate,2610-11-9,The study was performed on a tested substance with a higher content of active ingredient. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c62ce255-806f-413f-8dcf-24ec691b7dcc/documents/IUC5-fc6b66f2-cb97-4d99-b60d-760b63532178_2bd934ef-2264-40ab-b027-dba948710576.html,,,,,, Disodium 7-benzamido-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate,2610-11-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c62ce255-806f-413f-8dcf-24ec691b7dcc/documents/IUC5-fc6b66f2-cb97-4d99-b60d-760b63532178_2bd934ef-2264-40ab-b027-dba948710576.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Disodium 7-benzamido-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate,2610-11-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c62ce255-806f-413f-8dcf-24ec691b7dcc/documents/IUC5-fc6b66f2-cb97-4d99-b60d-760b63532178_2bd934ef-2264-40ab-b027-dba948710576.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Hexamethyldisiloxane,107-46-0," In a 28-day repeated oral gavage study (Shin-Etsu Chemical Co, 1994) in rats that was conducted using a test protocol that is comparable to the appropriate OECD test guideline, and in compliance with GLP, the NOAEL for HMDS was 160 mg/kg bw/day based on reduced food consumption, reduced body weight gain, increase organ weights (liver, spleen and brain), changes to white cell count and corpuscular parameters in male rats that received 640 mg/kg bw/day.   In a 2-generation reproductive toxicity whole body inhalation study in SD rats, the evaluation of endpoints relevant to the assessment of repeat dose toxicity resulted in the observation of brown pigment in the periportal areas of the liver in the F1 generation. These hepatic findings were considered to be human relevant and adverse, therefore the repeat dose NOAEC was 400 ppm (2657 mg/m³).  In a two-year combined chronic toxicity and oncogenicity whole body vapour inhalation study in Fischer 344 rats, conducted to GLP (Research and Consulting Company Ltd, 2005), the target organs of hexamethyldisiloxane were kidney, nasal cavity and testes. Effects in the kidneys were considered species-specific (alpha-2 u-globulin mediated mechanism). Effects in the nasal cavity were were consistent with exposure to a mild irritant but also commonly seen in ageing rats and therefore considered to be non-specific and non-adverse. Effects on the testes (Leydig cell tumours) were increased following exposure to all concentrations, but they are considered to be a spontaneous finding as they are common to Fischer 344 rats and were also observed in control animals. Therefore the NOAEC for systemic effects relevant to humans is ≥5000 ppm (33200 mg/m³). The key dermal study is a 28-day repeated dose dermal toxicity study in rats (Dow Corning Corporation, 1993), conducted using a protocol similar to OECD 410, and to GLP, the NOAEL was considered to be 1000 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6cf08885-1511-4fc6-9316-5e9dbb445c30/documents/c5b53611-bfad-4a9b-af0a-3b27d42de6c4_66c2fefd-993b-4c56-87c1-f5f40e53beca.html,,,,,, Hexamethyldisiloxane,107-46-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6cf08885-1511-4fc6-9316-5e9dbb445c30/documents/c5b53611-bfad-4a9b-af0a-3b27d42de6c4_66c2fefd-993b-4c56-87c1-f5f40e53beca.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,160 mg/kg bw/day,,rat Hexamethyldisiloxane,107-46-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6cf08885-1511-4fc6-9316-5e9dbb445c30/documents/c5b53611-bfad-4a9b-af0a-3b27d42de6c4_66c2fefd-993b-4c56-87c1-f5f40e53beca.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat Hexamethyldisiloxane,107-46-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6cf08885-1511-4fc6-9316-5e9dbb445c30/documents/c5b53611-bfad-4a9b-af0a-3b27d42de6c4_66c2fefd-993b-4c56-87c1-f5f40e53beca.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"2,657 mg/m3",,rat Hexamethyldisiloxane,107-46-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6cf08885-1511-4fc6-9316-5e9dbb445c30/documents/c5b53611-bfad-4a9b-af0a-3b27d42de6c4_66c2fefd-993b-4c56-87c1-f5f40e53beca.html,Repeated dose toxicity – local effects,dermal,NOAEL,"1,000 ",no adverse effect observed,rat Hexamethyldisiloxane,107-46-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6cf08885-1511-4fc6-9316-5e9dbb445c30/documents/c5b53611-bfad-4a9b-af0a-3b27d42de6c4_66c2fefd-993b-4c56-87c1-f5f40e53beca.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"33,200 mg/m3",no adverse effect observed,rat Hexamethyldisiloxane,107-46-0," In the key oral acute toxicity study (Bushy Run Research Center, 1982) in rats the LD50 was determined to be > 16.0 ml/kg (12.16 g/kg bw) for males and females.  The key inhalation study (Dow Corning Corporation, 1997) in rats gave an LC50 of 15956 ppm (ca. 106 mg/l).  In the key acute dermal toxicity study (Institut Francais de Recherches et Essais Biologiques, 1982), the LD50 for male and female rats was determiend to be >2000 mg/kg.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6cf08885-1511-4fc6-9316-5e9dbb445c30/documents/b9439d05-b9ea-4304-af49-b3a62174ae57_66c2fefd-993b-4c56-87c1-f5f40e53beca.html,,,,,, Hexamethyldisiloxane,107-46-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6cf08885-1511-4fc6-9316-5e9dbb445c30/documents/b9439d05-b9ea-4304-af49-b3a62174ae57_66c2fefd-993b-4c56-87c1-f5f40e53beca.html,,oral,LD50,"12,160 mg/kg bw",adverse effect observed, Hexamethyldisiloxane,107-46-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6cf08885-1511-4fc6-9316-5e9dbb445c30/documents/b9439d05-b9ea-4304-af49-b3a62174ae57_66c2fefd-993b-4c56-87c1-f5f40e53beca.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Hexamethyldisiloxane,107-46-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6cf08885-1511-4fc6-9316-5e9dbb445c30/documents/b9439d05-b9ea-4304-af49-b3a62174ae57_66c2fefd-993b-4c56-87c1-f5f40e53beca.html,,inhalation,LC50,"106,000 mg/m3",adverse effect observed, "Butanedioic acid, sulfo-, C-C16-18-alkyl esters, disodium salt",91697-07-3," No repeated dose toxicity study is available for the target substance C16 -18 sulfosuccinate. The repeated dose toxicity was assessed based on information of a read-across substance. A combined repeated dose and reproductive/developmental screening study which was performed with a close homolog C12 -18 sulfosuccinate according to OECD guideline 422 showed NOAEL-levels of 60 mg/kg bw for paternal/maternal toxicity, 120 mg/kg bw for reproductive toxicity and 120 mg/kg bw for developmental toxicity. For risk assessment, the lowest NOAEL of 60 mg/kg bw with the read-across substance C12 -18 sulfosuccinate tested in the OECD 422 study was selected. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b99d58aa-9edc-4314-8ce0-375ab65adcfc/documents/396c3ec9-a183-492b-a3d2-af6d26e1fdad_2e0df4d1-b8fd-4112-af1c-527e89c5b259.html,,,,,, "Butanedioic acid, sulfo-, C-C16-18-alkyl esters, disodium salt",91697-07-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b99d58aa-9edc-4314-8ce0-375ab65adcfc/documents/396c3ec9-a183-492b-a3d2-af6d26e1fdad_2e0df4d1-b8fd-4112-af1c-527e89c5b259.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat "Butanedioic acid, sulfo-, C-C16-18-alkyl esters, disodium salt",91697-07-3," No acute oral toxicity study is available for the target substance C16 -18 Sulfosuccinate. The acute oral toxicity of the source substance C12-18 Sulfosuccinate is low. A key study is available with test item containing ≥ 90 % a.i. dosed by gavage in Wistar rats at 480, 1400 and 2000 mg/kg bw (BASF SE, 1987). Five (for low and mid dose) and two rats (for high dose) were used per sex. Clinical observations and gross macroscopic observations were observed at all dose levels. The LD50 was between 580 and 1400 mg/kg for male and female rats, and therefore the test item was considered harmful. Two supporting studies for acute oral toxicity by gavage were available. In the first supporting study, the test item containing ≥ 90 % a.i. was tested by oral gavage in male and female Wistar rats (BASF SE, 1986). The male LD50was > 2000mg/kg bw, the female male LD50was ca. 1400 mg/kg bw. In the second supporting study, the test item containing ≥ 90 % a.i. was tested by oral gavage in male Wistar rats (BASF SE, 1969). The test item was administered by single gavage in aqua dest. as solvent and an application volume of 20 mL/kg bw to fasted animals at doses of 1580, 1990, 2510 and 3160 mg/kg bw. Ten male rats were used per sex and dose. The LD50 was 2400 mg/kg bw. In conclusion, the test item is considered of low toxic potential based on the most dentrimental study, indicating an LD50 between 580 and 1400 mg/kg bw. For the LD50 value, 580 mg/kg bw was used as worst case value. Acute dermal toxicity: No acute dermal toxicity study is availabe for the target substance C16 -18 Sulfosuccinate. The acute dermal toxicity of the source substance C12-18 Sulfosuccinate is low. A key study for acute dermal toxicity according to OECD 402 was conducted with the substance containing > 95 % a.i. (BASF, 2013). A dose level of 2000 mg/kg bw was employed. The test item was applied once for 24 hours on the shaved intact dorsal skin of rats (5 cm x 6 cm, approx. 1/10 of body surface). This treatment was followed by an observation period of 2 weeks. There were no signs of toxicity and no deaths. A very slight erythema (barely perceptible) on the application site was observed in all 5 of 5 male and 5 of 5 female animals on test days 2 and 3. All animals gained the expected body weight throughout the whole experimental period. No macroscopic findings were observed at necropsy. In conclusion, as LD50exceeds 2000 mg/kg bw and only very slight erythema was observed, there is no acute dermal toxicity hazard. The same is assumed for C16 -18 Sulfosuccinate. Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulfosuccinates due to their substance properties. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b99d58aa-9edc-4314-8ce0-375ab65adcfc/documents/575c8fd5-858a-4c71-8a44-929b57e46eb2_2e0df4d1-b8fd-4112-af1c-527e89c5b259.html,,,,,, "Butanedioic acid, sulfo-, C-C16-18-alkyl esters, disodium salt",91697-07-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b99d58aa-9edc-4314-8ce0-375ab65adcfc/documents/575c8fd5-858a-4c71-8a44-929b57e46eb2_2e0df4d1-b8fd-4112-af1c-527e89c5b259.html,,oral,LD50,580 mg/kg bw,adverse effect observed, "Butanedioic acid, sulfo-, C-C16-18-alkyl esters, disodium salt",91697-07-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b99d58aa-9edc-4314-8ce0-375ab65adcfc/documents/575c8fd5-858a-4c71-8a44-929b57e46eb2_2e0df4d1-b8fd-4112-af1c-527e89c5b259.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)",27344-41-8,"oral: NOAEL (female) = 226 mg/kg bw., NOAEL (male) = 190 mg/kg bw. CIBA, 1990, OECD 453 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3669e7ee-d2b1-414f-ba75-4076787a016f/documents/IUC5-2fdeda2a-0d8f-49fe-b43e-925a5adf3dca_dac6d2be-dc6c-48e8-874c-84d5da26dbba.html,,,,,, "Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)",27344-41-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3669e7ee-d2b1-414f-ba75-4076787a016f/documents/IUC5-2fdeda2a-0d8f-49fe-b43e-925a5adf3dca_dac6d2be-dc6c-48e8-874c-84d5da26dbba.html,Chronic toxicity – systemic effects,oral,NOAEL,190 mg/kg bw/day,,rat "Disodium 2,2'-([1,1'-biphenyl]-4,4'-diyldivinylene)bis(benzenesulphonate)",27344-41-8,"oral: LD50 > 2000 mg/kg bw, CIBA, 281834, 1990, OECD 401dermal: LD50 > 2000 mg/kg bw; CIBA, 281845, 1990, OECD 402inhalation: LC50 = 3.92 mg/L air (4 hour exposition); CIBA, 280980, 1990, OECD 403 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3669e7ee-d2b1-414f-ba75-4076787a016f/documents/IUC5-fa1cb844-8bc0-4bf9-84d0-9279dd36dcb9_dac6d2be-dc6c-48e8-874c-84d5da26dbba.html,,,,,, "Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)",14025-15-1, One well performed and reported subchronic oral toxicity study was available.   ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b11c29f-c2ae-4cb8-bce1-28a1fe774506/documents/IUC5-672fb7fc-9c20-4ca8-b65e-f21bdbb89f3c_dcf69085-d14c-4db4-b963-ac6c9cf76c02.html,,,,,, "Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)",14025-15-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b11c29f-c2ae-4cb8-bce1-28a1fe774506/documents/IUC5-672fb7fc-9c20-4ca8-b65e-f21bdbb89f3c_dcf69085-d14c-4db4-b963-ac6c9cf76c02.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,150 mg/kg bw/day,,rat "Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)",14025-15-1," The oral LD50 value in rats was 890 mg/kg bw; the 4-h LC50 value is in excess of 5.30 g/m3. No acute dermal toxicity studies are available but based on read across (see also section 13), acute dermal toxicity following exposure to EDTA-CuNa2 is not expected.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b11c29f-c2ae-4cb8-bce1-28a1fe774506/documents/IUC5-15dc1a42-3867-4caf-9293-d0ce3c405398_dcf69085-d14c-4db4-b963-ac6c9cf76c02.html,,,,,, "Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)",14025-15-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b11c29f-c2ae-4cb8-bce1-28a1fe774506/documents/IUC5-15dc1a42-3867-4caf-9293-d0ce3c405398_dcf69085-d14c-4db4-b963-ac6c9cf76c02.html,,oral,LD50,890 mg/kg bw,adverse effect observed, Disodium 2-hydroxyethyliminodi(acetate),135-37-5,"Treatment-related microscopic changes characterized by renal tubular vacuolation with a slight increase in the incidence of basophilic tubules were noted in high dose male animals (500 mg/kg bw nominal; 205 mg/kg bw actual) after 13 weeks of oral treatment. With the exception of one high dose male, which died during the treatment free period (19 week) and had marked tubular vacuolation of the kidneys, no microscopic observations related to treatment were noted after the 4 week interim sacrifice. Further, the minimal to moderate vacuolation appeared reversible as it was not apparent after 4 weeks without treatment. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8f7da3c-de7c-4f58-836c-790493748d6d/documents/IUC5-c810b823-5cd5-4022-b30c-5c8691112ac7_6b6e674e-3a20-49e2-99c9-1304ce10980b.html,,,,,, Disodium 2-hydroxyethyliminodi(acetate),135-37-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8f7da3c-de7c-4f58-836c-790493748d6d/documents/IUC5-c810b823-5cd5-4022-b30c-5c8691112ac7_6b6e674e-3a20-49e2-99c9-1304ce10980b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,41 mg/kg bw/day,,rat Disodium 2-hydroxyethyliminodi(acetate),135-37-5,"The acute median lethal oral dose of EDG (acid) in male and female rats was determined to be 1600 (95% confidence limits: 1400-2000) mg/kg bw. A study with EDG-Na2 showed mortality in 1/3 rats treated at 2000 mg/kg bw. Although this could lead to the conclusion that the LD50 would be >2000 mg/kg bw, however, a possible second mortality in this group would have resulted in an LD50 value < 2000 mg/kg bw.    The acute percutaneous toxicity (LD50) of EDG Na salt was >2 mL/kg bw when administered as a 40% w/v slurry to New Zealand White rabbits; thus the dermal LD50 value was in excess of 800 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8f7da3c-de7c-4f58-836c-790493748d6d/documents/IUC5-7736c867-87a7-4f8a-92ed-7ea30ef4a42a_6b6e674e-3a20-49e2-99c9-1304ce10980b.html,,,,,, Disodium 2-hydroxyethyliminodi(acetate),135-37-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8f7da3c-de7c-4f58-836c-790493748d6d/documents/IUC5-7736c867-87a7-4f8a-92ed-7ea30ef4a42a_6b6e674e-3a20-49e2-99c9-1304ce10980b.html,,oral,LD50,"1,600 mg/kg bw",adverse effect observed, "Acetic acid, hydroxysulfo-, disodium salt",29736-24-1, NOAEL values of 250 mg/kg bw/day and 300 mg/kg bw/day were obtained from a 90 day study on a structural similar substance and from a 28 day study on the substance itself. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37019aa0-9d73-4682-a036-8f708695e6ee/documents/IUC5-b96eb009-cbb4-4ecf-b8a9-29151db85614_e9270b36-3c37-404b-b787-60d8c5712a5f.html,,,,,, "Acetic acid, hydroxysulfo-, disodium salt",29736-24-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37019aa0-9d73-4682-a036-8f708695e6ee/documents/IUC5-b96eb009-cbb4-4ecf-b8a9-29151db85614_e9270b36-3c37-404b-b787-60d8c5712a5f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 ,, "Acetic acid, hydroxysulfo-, disodium salt",29736-24-1,No indication for acute oral or acute dermal toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37019aa0-9d73-4682-a036-8f708695e6ee/documents/IUC5-aff931ce-b6d4-4d61-9c91-a085d3bea3af_e9270b36-3c37-404b-b787-60d8c5712a5f.html,,,,,, "Acetic acid, hydroxysulfo-, disodium salt",29736-24-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37019aa0-9d73-4682-a036-8f708695e6ee/documents/IUC5-aff931ce-b6d4-4d61-9c91-a085d3bea3af_e9270b36-3c37-404b-b787-60d8c5712a5f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Acetic acid, hydroxysulfo-, disodium salt",29736-24-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37019aa0-9d73-4682-a036-8f708695e6ee/documents/IUC5-aff931ce-b6d4-4d61-9c91-a085d3bea3af_e9270b36-3c37-404b-b787-60d8c5712a5f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Acetic acid, hydroxysulfo-, disodium salt",29736-24-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37019aa0-9d73-4682-a036-8f708695e6ee/documents/IUC5-aff931ce-b6d4-4d61-9c91-a085d3bea3af_e9270b36-3c37-404b-b787-60d8c5712a5f.html,,inhalation,LC50,"5,160 mg/m3",no adverse effect observed, Disodium C-isodecyl sulphonatosuccinate,37294-49-8," In a key OECD 422 study, read-across substance butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts (CAS 90268 -36 -3) was administered orally to rats at dose levels of 60, 120 or 300 mg test item/kg bw/day (Hansen, 2013). One of 10 male and one of 10 female animals of the high dose group died prematurely on test day 33 or on gestation day 9. Slight to moderate salivation was noted in a few male and female animals of the medium dose group, whereas in the (medium and) high dose group, effects comprised of piloerection and a slight to extreme salivation, reduced body weight, clinical chemistry changes, organ weights changes (thymus, liver), macroscopic changes (stomach) and histopathological changes in the liver (hepatocellular hypertrophy and macrovesicular vacuolation evoked by fatty change) and the non-glandular stomach (squamous cell hyperplasia) of male and female animals. These latter changes are considered to be related to a local activity of the test item. As humans lack a forestomach, the relevance of these changes for humans is questionable. A NOAEL of 60 mg/kg bw/day for maternal and paternal toxicity was concluded, which can also be accepted for the target substance (based upon read-across justification). Supporting dose range finding studies were available for the read across substances disodium isodecyl sulfosuccinate (CAS 37294 -29 -8) and butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts(CAS 90268 -36 -3), both applied by oral gavage to Wistar rats for 14 days, and both leading to a NOAEL of 300 mg/kg bw. Subchronic (90 -day) dietary toxicity studies were available for the target substance both in rats and dogs, however the studies were disregarded due to limitations compared to OECD 408 guideline. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d1a0d110-4eca-4b23-a214-d04f24cf3d0c/documents/b23c7b2a-ab2c-4578-84d2-5bd72e59f68d_ab7ef4e3-c0b5-49cf-8ee4-508fe7c14dfe.html,,,,,, Disodium C-isodecyl sulphonatosuccinate,37294-49-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d1a0d110-4eca-4b23-a214-d04f24cf3d0c/documents/b23c7b2a-ab2c-4578-84d2-5bd72e59f68d_ab7ef4e3-c0b5-49cf-8ee4-508fe7c14dfe.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat Disodium C-isodecyl sulphonatosuccinate,37294-49-8," In an acute oral toxicity study with rats (WIL Research 507498, key study) performed according to OECD/EC test guidelines, the oral LD50 of disodium isodecyl sulfosuccinate in Wistar rats was established to be within the range 300-2000 mg/kg body weight. The acute dermal toxicity showed an LD50 > 5000 mg/kg in rabbits. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1a0d110-4eca-4b23-a214-d04f24cf3d0c/documents/f8d8ba60-b10a-4c96-9749-2f11a1bccb0d_ab7ef4e3-c0b5-49cf-8ee4-508fe7c14dfe.html,,,,,, Disodium C-isodecyl sulphonatosuccinate,37294-49-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1a0d110-4eca-4b23-a214-d04f24cf3d0c/documents/f8d8ba60-b10a-4c96-9749-2f11a1bccb0d_ab7ef4e3-c0b5-49cf-8ee4-508fe7c14dfe.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Disodium 4-[2-[2-[2-(dodecyloxy)ethoxy]ethoxy]ethyl] 2-sulphonatosuccinate,40754-59-4," Estimated LD50 was considered to be 170000 mg/kg bw when rat were treated disodium 4-oxo-2-sulfonato-5, 8, 11, 14-tetraoxahexacosan-1-oate orally.    ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fe1b173-917c-4dcf-846e-2eb2a371dfba/documents/b584d039-d88f-477e-ab87-2a378aeffde4_f9015398-aee3-4d3e-8a42-28a35ad6f37a.html,,,,,, Disodium 4-[2-[2-[2-(dodecyloxy)ethoxy]ethoxy]ethyl] 2-sulphonatosuccinate,40754-59-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fe1b173-917c-4dcf-846e-2eb2a371dfba/documents/b584d039-d88f-477e-ab87-2a378aeffde4_f9015398-aee3-4d3e-8a42-28a35ad6f37a.html,,oral,LD50,"170,000 mg/kg bw",no adverse effect observed, Disodium (Z)-1-(octadec-9-enyl) 2-sulphonatosuccinate,94213-67-9," The acute oral toxicity of Disodium (Z)-1-(octadec-9-enyl) 2-sulphonatosuccinate (CAS 94213 -67 -9) was derived from a key study with read across substance CAS 90268-36-3 containing ≥90% act. ingr., showing LD50 values of <1400 mg/kg and >580 mg/kg for male rats and <1400 mg/kg and >580 mg/kg for female rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78534c01-3093-4e72-ba76-7e24123163fa/documents/25d320a3-c634-4a23-9080-e889387a4d9a_4ca40e1a-a0a9-4b16-ba8d-1c71a0a60c28.html,,,,,, Disodium (Z)-1-(octadec-9-enyl) 2-sulphonatosuccinate,94213-67-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78534c01-3093-4e72-ba76-7e24123163fa/documents/25d320a3-c634-4a23-9080-e889387a4d9a_4ca40e1a-a0a9-4b16-ba8d-1c71a0a60c28.html,,oral,LD50,580 mg/kg bw,adverse effect observed, "1H-Benzimidazole-4,6-disulfonic acid, 2,2'-(1,4-phenylene)bis-, disodium salt",180898-37-7," NOAEL (13 weeks, rat, oral) > 10000 ppm (subchronic) (OECD 408; GLP compliant) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5b4697a-f925-40d6-ba34-a7184ea78906/documents/IUC5-16eaa550-1946-4394-afaa-db52a090b2f5_e0cf0cf2-f11a-458c-b24b-4fbc14f89d7c.html,,,,,, "1H-Benzimidazole-4,6-disulfonic acid, 2,2'-(1,4-phenylene)bis-, disodium salt",180898-37-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5b4697a-f925-40d6-ba34-a7184ea78906/documents/IUC5-16eaa550-1946-4394-afaa-db52a090b2f5_e0cf0cf2-f11a-458c-b24b-4fbc14f89d7c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,695 mg/kg bw/day,,rat "1H-Benzimidazole-4,6-disulfonic acid, 2,2'-(1,4-phenylene)bis-, disodium salt",180898-37-7," Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 401 (1987); GLP compliant) Acute inhalation toxicity: LC50 > 1.87 mg/L air (analytical concentration)(OECD 403 (1981); GLP compliant) Acute dermal toxicity: LD50 > 20000 mg/kg bw of 10% aqueous solution of the test material (2000 mg/kg bw active ingredient)(OECD 402 (1987), GLP compliant) The key study reliable without restrictions meets the requirements in order to cover the endpoint. The second study, which is also reliable without restrictions, is chosen to be a supportive study (RL 2), since only a 10% aqueous solution of the test substance was tested. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5b4697a-f925-40d6-ba34-a7184ea78906/documents/IUC5-1680c661-04a3-475b-8d37-084f23ca25fb_e0cf0cf2-f11a-458c-b24b-4fbc14f89d7c.html,,,,,, "1H-Benzimidazole-4,6-disulfonic acid, 2,2'-(1,4-phenylene)bis-, disodium salt",180898-37-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5b4697a-f925-40d6-ba34-a7184ea78906/documents/IUC5-1680c661-04a3-475b-8d37-084f23ca25fb_e0cf0cf2-f11a-458c-b24b-4fbc14f89d7c.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1H-Benzimidazole-4,6-disulfonic acid, 2,2'-(1,4-phenylene)bis-, disodium salt",180898-37-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5b4697a-f925-40d6-ba34-a7184ea78906/documents/IUC5-1680c661-04a3-475b-8d37-084f23ca25fb_e0cf0cf2-f11a-458c-b24b-4fbc14f89d7c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1H-Benzimidazole-4,6-disulfonic acid, 2,2'-(1,4-phenylene)bis-, disodium salt",180898-37-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5b4697a-f925-40d6-ba34-a7184ea78906/documents/IUC5-1680c661-04a3-475b-8d37-084f23ca25fb_e0cf0cf2-f11a-458c-b24b-4fbc14f89d7c.html,,inhalation,discriminating conc.,"1,870 mg/m3",no adverse effect observed, Disodium hydrogenorthophosphate,7558-79-4,"The key information has been provided on the analogous substance sodium aluminium phosphate. The key study (Matalski K, 1972b) has been selected as the most reliable or appropriate study for use in the derivation of DNELS. In addition a reliable 28 day study (OECD 422) exists for the analogous substance dipotassium hydrogenorthophosphate (Shim, 2005), however as the study is only a 28-day study and in accordance with Annex XI, Section 3.2 (a.ii) of Regulation (EC) N0. 1907/2006 (REACH) the data are not considered to be suitable for derivation of a DNEL as subchronic data are available. Furthermore, full access to the data has not been granted to all registrants.Additional supporting data provided on sodium dihydrogenorthophosphate are not considered to fulfil the guideline requirements for repeated dose toxicity (sub-chronic or chronic). Full justification for the choice of data and the rationale for read-across can be found below. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/620ed8f4-245d-4cc6-bafd-916d8f7f75ac/documents/IUC5-b009f957-67b5-4c70-a276-82c4d58c5503_6d06dba0-fcdb-4db8-af38-c7bef187ee73.html,,,,,, Disodium hydrogenorthophosphate,7558-79-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/620ed8f4-245d-4cc6-bafd-916d8f7f75ac/documents/IUC5-b009f957-67b5-4c70-a276-82c4d58c5503_6d06dba0-fcdb-4db8-af38-c7bef187ee73.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,322.88 mg/kg bw/day,,dog Disodium hydrogenorthophosphate,7558-79-4,"Acute oral toxicity: Three studies are available to assess the acute oral toxicity of disodium hydrogenorthophosphate. All studies indicate that disodium hydrogenorthophosphate has a low potential for systemic toxicity following acute administration via the oral route. The key study (Bradshaw J , 2010) has been conducted according to a current guideline (OECD 420) according to the principles of GLP. The acute oral median dose (LD50) of disodium hydrogenorthophosphate in the female Wistar strain rat was estimated to be > 2000 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP). Additional supporting data (Birch MD, 1973 and Smyth HF, 1969) are considered to be sufficient to support the overall classification; however these studies are not sufficient as stand-alone data sources for this endpoint.Acute inhalation toxicity: One key study is available to assess the acute inhalation toxicity of the analogous substance sodium dihydrogenorthophosphate. The key study (Signorin J, 1993) has been conducted according to the relevant guidelines (EU and US) and according to the principles of GLP. The acute inhalation median concentration (LC50) in male and female rats was estimated to be > 0.83 mg/L (the maximum attainable concentration). It is therefore anticipated that disodium hydrogenorthophosphate is of equally low concern via the inhalation route (see 'discussion' for justification).Acute dermal toxicity: One key study and a number of supporting studies are provided. All studies support no classification. The key study (Moore, 2006) details the acute dermal toxicity of the analogue substance potassium pentahydrogen bis(phosphate) which has an LD50 of >2,000 mg /kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP). This classification can be read across to disodium hydrogenorthophosphate on the basis of the argumentation provided below (see 'discussion' for justification). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/620ed8f4-245d-4cc6-bafd-916d8f7f75ac/documents/IUC5-824e8f25-f45d-42e7-b4f4-eaabd64d5b36_6d06dba0-fcdb-4db8-af38-c7bef187ee73.html,,,,,, Disodium dihydrogenpyrophosphate,7758-16-9," One key study is available on an analogous substance (Seo D, 2011) for the sub-chronic toxicity endpoint. This study is considered to be a reliability 2 study as it has been conducted to the appropriate guideline (OECD 408) and under the conditions of GLP. On the basis of this study the NOAEL was determined to be 500 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef757355-16c7-42c2-bc9c-16fb9520361a/documents/IUC5-9e7705bd-9143-408e-a718-2c36ae85c5be_28833427-da75-4a27-9ecd-0e8963b79a41.html,,,,,, Disodium dihydrogenpyrophosphate,7758-16-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef757355-16c7-42c2-bc9c-16fb9520361a/documents/IUC5-9e7705bd-9143-408e-a718-2c36ae85c5be_28833427-da75-4a27-9ecd-0e8963b79a41.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Disodium dihydrogenpyrophosphate,7758-16-9,"Acute oral toxicity: The oral LD50 value is derived using a weight of evidence approach. Taking into account the five studies available on disodium dihydrogenpyrophosphate and the available studies on tetrapotassium pyrophosphate and tetrasodium pyrophosphate which are considered to be of similar systemic toxicity, the weight of evidence indicates that the oral LD50 is greater than the classification limit of 2000 mg/kg bw/day.Acute inhalation toxicity: One key study is available to assess the acute inhalation toxicity of disodium dihydrogenpyrophosphate. Disodium dihydrogenpyrophosphate is considered to exhibit a low potential toxicity via the inhalation route and is not expected to be of significant concern. The key study (Signorin J, 1993) has been conducted according to the relevant guidelines (EU and US) and according to the principles of GLP. The acute inhalation median concentration (LC50) of disodium dihydrogenpyrophosphate in male and female rats was estimated to be > 0.58 mg/L (the maximum attainable concentration). Acute dermal toxicity: One Key study is available to assess the acute dermal toxicity of disodium dihydrogenpyrophosphate. The key study (Bradshaw, 2010) has been conducted according to a current guideline (OECD Method 402) and according to the principles of GLP. The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be > 2000 mg/kg bodyweight and is therefore not considered to be classified in accordance with Regulation (EC) No. 1272/2008. In addition, a number of supporting studies on the analogous substances tetrapotassium pyrophosphate and tetrasodium pyrophosphate are provided to support the conclusion that sodium and potassium pyrophosphates exhibit low systemic toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef757355-16c7-42c2-bc9c-16fb9520361a/documents/IUC5-5d8bf869-ae7f-4e8d-a7c9-6c1821d4be06_28833427-da75-4a27-9ecd-0e8963b79a41.html,,,,,, Disodium sebacate,17265-14-4, After 6 months repeated exposure in feed the derived NOEL of the test substance was > 1000 mg/kg bw in rats and > 1500 mg/kg bw in rabbits. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56a2bcd1-8f81-4e29-9801-881a25df4b68/documents/d5c2ac64-b3a0-4917-91e0-cc016303d15a_7e3a403c-3406-4567-b6ea-7163a432156e.html,,,,,, Disodium sebacate,17265-14-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56a2bcd1-8f81-4e29-9801-881a25df4b68/documents/d5c2ac64-b3a0-4917-91e0-cc016303d15a_7e3a403c-3406-4567-b6ea-7163a432156e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Disodium sebacate,17265-14-4, The oral LD50 was ≥ 5000 mg/kg in rats. The dermal LD50 of a structurally related compound was ≥ 2000 mg/kg.   ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56a2bcd1-8f81-4e29-9801-881a25df4b68/documents/6211e8b2-7ad7-438b-b7fc-f0bd552fd536_7e3a403c-3406-4567-b6ea-7163a432156e.html,,,,,, Disodium sebacate,17265-14-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56a2bcd1-8f81-4e29-9801-881a25df4b68/documents/6211e8b2-7ad7-438b-b7fc-f0bd552fd536_7e3a403c-3406-4567-b6ea-7163a432156e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Disodium sebacate,17265-14-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56a2bcd1-8f81-4e29-9801-881a25df4b68/documents/6211e8b2-7ad7-438b-b7fc-f0bd552fd536_7e3a403c-3406-4567-b6ea-7163a432156e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium selenite,10102-18-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Literature data of good quality (Klimisch 2). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Read-across from GLP study of hight quality (Klimisch 1) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a27e8b4b-d310-43b3-b1cb-80870b3db17c/documents/9340bae4-02ea-4d71-952d-b4389a8a9ba3_3f888d24-2ad4-41b5-9b78-fa7178522765.html,,,,,, Sodium selenite,10102-18-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a27e8b4b-d310-43b3-b1cb-80870b3db17c/documents/9340bae4-02ea-4d71-952d-b4389a8a9ba3_3f888d24-2ad4-41b5-9b78-fa7178522765.html,,oral,LD50,7 mg/kg bw,adverse effect observed, Sodium selenite,10102-18-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a27e8b4b-d310-43b3-b1cb-80870b3db17c/documents/9340bae4-02ea-4d71-952d-b4389a8a9ba3_3f888d24-2ad4-41b5-9b78-fa7178522765.html,,inhalation,LC50,0.052 mg/m3,adverse effect observed, Disodium succinate,150-90-3," Repeated dose toxicity: Oral The NOAEL  was considered to be 2500 mg/kg/day) when Sprague Dawley male rats were treated with test substance. Repeated dose toxicity: Inhalation Disodium succinate has a particle size distribution of 53-150 micron, so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route is considered for waiver. Repeated dose toxicity: Dermal The acute toxicity value for Disodum succinate (150-90-3) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 2 Disodum succinate shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Disodum succinate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67f9f2a6-14b4-4f99-b7eb-09e6d6bb3135/documents/b1726cbf-a6ec-4ea9-a459-e38c65f8634a_f3e7b11b-ce84-4623-8750-f49c35df11d8.html,,,,,, Disodium succinate,150-90-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67f9f2a6-14b4-4f99-b7eb-09e6d6bb3135/documents/b1726cbf-a6ec-4ea9-a459-e38c65f8634a_f3e7b11b-ce84-4623-8750-f49c35df11d8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"2,500 mg/kg bw/day",,rat Disodium succinate,150-90-3," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical; also it has a particle size distribution of 53-150 micron, so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67f9f2a6-14b4-4f99-b7eb-09e6d6bb3135/documents/4476d6ae-70b4-4e43-99da-056ec0b679fa_f3e7b11b-ce84-4623-8750-f49c35df11d8.html,,,,,, Disodium succinate,150-90-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67f9f2a6-14b4-4f99-b7eb-09e6d6bb3135/documents/4476d6ae-70b4-4e43-99da-056ec0b679fa_f3e7b11b-ce84-4623-8750-f49c35df11d8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Disodium succinate,150-90-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67f9f2a6-14b4-4f99-b7eb-09e6d6bb3135/documents/4476d6ae-70b4-4e43-99da-056ec0b679fa_f3e7b11b-ce84-4623-8750-f49c35df11d8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Disodium tartrate,868-18-8, Oral (no guideline followed): NOAEL ≥ 3100 mg/kg bw/day (males); NOAEL ≥ 4100 mg/kg bw/day (females); RA from source substance Monosodium L(+) tartrate (CAS 526 -94 -3) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66633f36-4aab-4a3a-ad74-491145c25801/documents/16d461de-195a-4094-9aa2-8cf619fb44a4_dc4e50b7-6b3e-4578-8b7a-b1df4ed7cc82.html,,,,,, Disodium tartrate,868-18-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66633f36-4aab-4a3a-ad74-491145c25801/documents/16d461de-195a-4094-9aa2-8cf619fb44a4_dc4e50b7-6b3e-4578-8b7a-b1df4ed7cc82.html,Chronic toxicity – systemic effects,oral,NOAEL,"3,100 mg/kg bw/day",,rat Disodium tartrate,868-18-8," Oral (no guideline followed), rat: LD50 > 3100 mg/kg bw RA from source substance Monosodium L(+) tartrate (CAS 526 -94 -3) Inhalation: no data available Dermal: no data available ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66633f36-4aab-4a3a-ad74-491145c25801/documents/69a6697a-d72d-466d-9856-8ed5a984c1e2_dc4e50b7-6b3e-4578-8b7a-b1df4ed7cc82.html,,,,,, Disodium tartrate,868-18-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66633f36-4aab-4a3a-ad74-491145c25801/documents/69a6697a-d72d-466d-9856-8ed5a984c1e2_dc4e50b7-6b3e-4578-8b7a-b1df4ed7cc82.html,,oral,LD50,"3,100 mg/kg bw",no adverse effect observed, Disodium 4-[2-[(1-oxoundec-10-enyl)amino]ethyl] 2-sulphonatosuccinate,26650-05-5,"In a supporting 5 days repeated dose oral toxicity study in rats with the registered substance, slightly reduced relative weights of liver and kidney were observed. A  supporting 14-day dose range finding study with the registered substance was conducted in Wistar rats by oral gavage at 0 and 1000 mg active ingredient /kg bw/day. There were no test item-related mortality, clinical signs, effects on body weight, body weight gain nor food intake. No test item-related adverse effects were seen on the examined haematology and clinical chemistry parameters. No test item related gross macroscopic findings were recorded at necropsy in any animals. The differences in organ weights did not reach statistical significance and were not considered test item related. In conclusion, the registered substance revealed no test item-related adverse effects. In a key combined reproduction and/or development toxicity study according to OECD guideline 422, the registered substance was dosed orally by gavage to rats at dose levels of 100, 300 and 1000 mg active ingredient/kg bw/day. In summary the substance did not result in test item related mortality or adverse clinical signs, effects on bodyweight, body weight gain, and food consumption, functional observation battery (FOB) and locomotor activity measurement. No test item related findings were seen in the clinical pathology parameters.  No test item-related macroscopic and microscopic findings were observed in evaluated males and females from any of the dose groups. NOAEL (no-observed-adverse-effect level) for repeated dose toxicity was 1000 mg/kg bw/day. Finally a supporting repeated dose dermal toxicity study in rabbits with the registered substance dosed at 0.357 mL/kg, 0.714 mL/kg and 1.428 mL/kg with a product (50 % aqueous solution) for 20 applications showed a mild to moderate irritation but no edema. No dose related effects occurred on body weight gain and food consumption. The urine and blood data showed no significant deviations from the norms, respectively between the initial and final readings. Neither the macroscopical nor the microscopical histopathological examination of the tissues of 1 animal each of the group with the lowest and highest dose level revealed any serious damage. The treated skin of the animal treated showed slight hyperkeratosis and slight chronical inflammation in the stratum papilare. Inhalation toxicity was waived as the exposure to workers is unlikely due to low vapour pressure ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/055f171c-52b8-47eb-8a11-4734790ecf08/documents/5d8e8599-6cb9-4001-b2c7-7a0aa8343f65_076cb617-e40e-4257-b93e-e89ce48f0205.html,,,,,, Disodium 4-[2-[(1-oxoundec-10-enyl)amino]ethyl] 2-sulphonatosuccinate,26650-05-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/055f171c-52b8-47eb-8a11-4734790ecf08/documents/5d8e8599-6cb9-4001-b2c7-7a0aa8343f65_076cb617-e40e-4257-b93e-e89ce48f0205.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Disodium 4-[2-[(1-oxoundec-10-enyl)amino]ethyl] 2-sulphonatosuccinate,26650-05-5,"A key oral acute toxicity study was performed in rats by single oral dose of SBU 185 (50% active ingredient), demonstrating an LD50 > 2450 mg act. ingr./kg bw.  Supporting acute toxicity studies were available in mice either by single  oral and single subcutaneous dose of SBU-185 (at least 49% active ingredient), demonstrating LD50 of ca. 3450 and 1617 mg act. ingr./kg bw, respectively. Inhalation acute toxicity is waived based on the low vapour pressure of the registered substance which  is1.75 x 10E-18 hPa at 25°C (EPIWIN). A key study for acute dermal toxicity in rats with read-across substance Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1- oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts showed and LD50 >2000 mg active ingredient/kg bw and revealed no signs of toxicity and no deaths at tested dose of 2000 mg/kg.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/055f171c-52b8-47eb-8a11-4734790ecf08/documents/85e3d9f9-e6d1-46ff-b572-c853d3e99d53_076cb617-e40e-4257-b93e-e89ce48f0205.html,,,,,, Disodium 4-[2-[(1-oxoundec-10-enyl)amino]ethyl] 2-sulphonatosuccinate,26650-05-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/055f171c-52b8-47eb-8a11-4734790ecf08/documents/85e3d9f9-e6d1-46ff-b572-c853d3e99d53_076cb617-e40e-4257-b93e-e89ce48f0205.html,,oral,LD50,"2,450 mg/kg bw",no adverse effect observed, Disodium 4-[2-[(1-oxoundec-10-enyl)amino]ethyl] 2-sulphonatosuccinate,26650-05-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/055f171c-52b8-47eb-8a11-4734790ecf08/documents/85e3d9f9-e6d1-46ff-b572-c853d3e99d53_076cb617-e40e-4257-b93e-e89ce48f0205.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dimethylbis[2-[(1-oxooctadecyl)oxy]ethyl]ammonium chloride,67846-68-8,"- Subacute (28 day) study; oral (gavage), rat (Wistar); 5/sex/dose), according to OECD guideline 407, GLP; NOAEL = 1000 mg/kg bw/day (highest dose level tested)- Subacute (28 day) study; oral (gavage), rat (Charles River CD; 25/sex/dose), equivalent to OECD guideline 407, GLP; NOAEL = 500 mg/kg bw/d (highest dose level tested); read across from MDEA-Esterquat C16-18 and C18 unsatd. - Subchronic (91 day) study; oral (gavage), rat (Crl CD BR; 15/sex/dose), equivalent to OECD guideline 408, GLP; NOAEL = 500 mg/kg bw/d (highest dose level tested); read across from MDEA-Esterquat C16-18 and C18 unsatd. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/4aeb06d5-fd94-41fa-8ff6-bb79ff37ff94/documents/IUC5-f219b40a-ba38-4ddb-a89e-b8835c861aca_1132cb78-eaaf-4757-b61c-581026cf5595.html,,,,,, Dimethylbis[2-[(1-oxooctadecyl)oxy]ethyl]ammonium chloride,67846-68-8,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/4aeb06d5-fd94-41fa-8ff6-bb79ff37ff94/documents/IUC5-f219b40a-ba38-4ddb-a89e-b8835c861aca_1132cb78-eaaf-4757-b61c-581026cf5595.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Dimethylbis[2-[(1-oxooctadecyl)oxy]ethyl]ammonium chloride,67846-68-8,"Acute oral toxicity: LD50 > 2000 mg/kg bw, rat, OECD Guideline 423, GLP compliantAcute dermal toxicity: LD50 > 2000 mg/kg bw, rabbit, OECD Guideline 402, GLP compliant; read-across MDEA-Esterquat C16-18 and C18 unsatd.Acute inhalation toxicity: inhalation is no relevant route of exposure ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aeb06d5-fd94-41fa-8ff6-bb79ff37ff94/documents/IUC5-7d295908-a5fb-4e4a-bd20-7f8697c3d3c6_1132cb78-eaaf-4757-b61c-581026cf5595.html,,,,,, Dimethylbis[2-[(1-oxooctadecyl)oxy]ethyl]ammonium chloride,67846-68-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aeb06d5-fd94-41fa-8ff6-bb79ff37ff94/documents/IUC5-7d295908-a5fb-4e4a-bd20-7f8697c3d3c6_1132cb78-eaaf-4757-b61c-581026cf5595.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dimethylbis[2-[(1-oxooctadecyl)oxy]ethyl]ammonium chloride,67846-68-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aeb06d5-fd94-41fa-8ff6-bb79ff37ff94/documents/IUC5-7d295908-a5fb-4e4a-bd20-7f8697c3d3c6_1132cb78-eaaf-4757-b61c-581026cf5595.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Dioctadecyl 3,3'-thiodipropionate",693-36-7,"Repeated dose, oral, subchronic: NOAEL = 1000 mg/kg bw/day, rat, OECD 408, GLP, 2023, K1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8064bcc8-3db6-4d55-bc00-426410568d87/documents/2811d271-103c-402d-a4b0-2f050c5477f5_4a5764ad-ba0a-4bfc-845c-ca0a0b7f398a.html,,,,,, "Dioctadecyl 3,3'-thiodipropionate",693-36-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8064bcc8-3db6-4d55-bc00-426410568d87/documents/2811d271-103c-402d-a4b0-2f050c5477f5_4a5764ad-ba0a-4bfc-845c-ca0a0b7f398a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Dioctadecyl 3,3'-thiodipropionate",693-36-7,"LD50 oral, rat: >5000 mg/kg bw LD50 dermal, rat: >2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8064bcc8-3db6-4d55-bc00-426410568d87/documents/02de8c8b-b700-4557-a8b3-11f1727f732d_4a5764ad-ba0a-4bfc-845c-ca0a0b7f398a.html,,,,,, "Dioctadecyl 3,3'-thiodipropionate",693-36-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8064bcc8-3db6-4d55-bc00-426410568d87/documents/02de8c8b-b700-4557-a8b3-11f1727f732d_4a5764ad-ba0a-4bfc-845c-ca0a0b7f398a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Dioctadecyl 3,3'-thiodipropionate",693-36-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8064bcc8-3db6-4d55-bc00-426410568d87/documents/02de8c8b-b700-4557-a8b3-11f1727f732d_4a5764ad-ba0a-4bfc-845c-ca0a0b7f398a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Diutan,125005-87-0,"A 4-week oral toxicity study of Diutan found no evidence of toxicity at the maximum tested dosage of 1000 mg/kg/day.The closely similar chemical analogue gellan gum has shown similarly low toxicity in a variety of repeat-dose studies, performed in different species. In a 13-week rat study, administration of gellan gum at up to 6% in the diet found no evidence of toxicity: the NOAEL of 6% in diet equated to achieved test substance intake s of 6.99-2.95 g/kg/day (males), 7.26-3.76 g/kg/day (females). In a 96-98 week mouse carcinogenicity study, feeding gellan gum at up to 3% in diet (overall achieved intakes 4.9 g/kg/day (males), 6.2 g/kg/day (females)) produced no overt signs of toxicity and no adverse histopathology findings. To support the use of gellan gum as a food additive, it has also been investigated using less commonly performed repeat-dose test protocols. Toxicology Monograph 724 (Food Additive Series 28, 1990) of the Joint FAO/WHO Expert Committee on Food Additives describes:- a carcinogenicity study using rats exposed to gellan gum in utero then fed for 2 further years at up to 5% in the diet, which found no neoplastic or non-neoplastic changes associated with test exposure- a 52-week beagle dog study using levels up to 6% in the diet which found no effect of treatment- a 28-day rhesus monkey study giving oral doses up to 3 g/kg/day which found no overt signs of toxicity.It is reasonable to predict that Diutan would show a similar pattern of low toxicity in subchronic and chronic toxicity studies. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a707f85d-5416-445a-8a02-4b3690cef308/documents/IUC5-7a79db7a-510b-4234-baa1-ff2ee1db8a86_164f3286-7261-4718-a1c4-c8438ae07088.html,,,,,, Diutan,125005-87-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a707f85d-5416-445a-8a02-4b3690cef308/documents/IUC5-7a79db7a-510b-4234-baa1-ff2ee1db8a86_164f3286-7261-4718-a1c4-c8438ae07088.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"4,900 mg/kg bw/day",,rat Diutan,125005-87-0,Reliable studies of acute oral and acute inhalation toxicity in the rat are available. Both found no deaths and no significant toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a707f85d-5416-445a-8a02-4b3690cef308/documents/IUC5-cb0f007e-b518-43af-8f97-be3363d92459_164f3286-7261-4718-a1c4-c8438ae07088.html,,,,,, "5,5-dimethylhydantoin",77-71-4,"Repeat oral dose studies, via gavage (90 days) with rats and chronic dietary studies in rats and dogs (104 weeks), on DMH produced no adverse effects in the rat at the highest dose level tested (NOAEL = 1000 mg/kg bw/day). In a 1-year dietary repeat-dose study in the dog, signs of toxicity, decreasing bodyweight, increase in adrenal weight and mild hypertrophy in the adrenal cortex, were observed at the highest dose level tested, however these were not considered to be of an adverse nature (NOAEL = 40,000 ppm, ie, 1000 mg/kg/d, NOEL = 12,000 ppm, ie, 300 mg/kg/d). A repeat dose (90 day) dermal study was performed in the rat at dose concentration of 39, 130 and 390 mg/kg/day. The highest dose tested was limited by solubility. No systemic toxicity or dermal irritation was observed. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c2ea501-9d2b-48c6-a100-10ca877e561d/documents/IUC5-62df4176-5be7-4e71-ba63-d7e27bda2e48_0984ad22-b915-41f7-ad3c-7585eb967980.html,,,,,, "5,5-dimethylhydantoin",77-71-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c2ea501-9d2b-48c6-a100-10ca877e561d/documents/IUC5-62df4176-5be7-4e71-ba63-d7e27bda2e48_0984ad22-b915-41f7-ad3c-7585eb967980.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,, "5,5-dimethylhydantoin",77-71-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c2ea501-9d2b-48c6-a100-10ca877e561d/documents/IUC5-62df4176-5be7-4e71-ba63-d7e27bda2e48_0984ad22-b915-41f7-ad3c-7585eb967980.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,390 mg/kg bw/day,, "5,5-dimethylhydantoin",77-71-4,An acute oral and dermal study have been performed. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c2ea501-9d2b-48c6-a100-10ca877e561d/documents/IUC5-44a99417-d909-4aae-8346-0e9d5fb9105b_0984ad22-b915-41f7-ad3c-7585eb967980.html,,,,,, "5,5-dimethylhydantoin",77-71-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c2ea501-9d2b-48c6-a100-10ca877e561d/documents/IUC5-44a99417-d909-4aae-8346-0e9d5fb9105b_0984ad22-b915-41f7-ad3c-7585eb967980.html,,oral,LD50,"5,000 mg/kg bw",, "5,5-dimethylhydantoin",77-71-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c2ea501-9d2b-48c6-a100-10ca877e561d/documents/IUC5-44a99417-d909-4aae-8346-0e9d5fb9105b_0984ad22-b915-41f7-ad3c-7585eb967980.html,,dermal,LD50,"20,000 mg/kg bw",, "1,3-bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione",6440-58-0,"DMDMH readily undergoes hydrolysis to DMH and therefore data is provided for both substances. In the case of long term testing, the data on DMH is considered more relevant. In a 90 day study with DMH the NOAEL was >1000 mg/kg and in 90 day dermal study the NOEL was 390 mg/kg (limited by solubility). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4247d81-db63-460e-ae47-5abf6fbc9cde/documents/IUC5-84de38c7-483b-41bc-b643-b42fc3dc2775_4c8f577e-99cc-4e2d-920e-bcb6b0345b17.html,,,,,, "1,3-bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione",6440-58-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4247d81-db63-460e-ae47-5abf6fbc9cde/documents/IUC5-84de38c7-483b-41bc-b643-b42fc3dc2775_4c8f577e-99cc-4e2d-920e-bcb6b0345b17.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,3-bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione",6440-58-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4247d81-db63-460e-ae47-5abf6fbc9cde/documents/IUC5-84de38c7-483b-41bc-b643-b42fc3dc2775_4c8f577e-99cc-4e2d-920e-bcb6b0345b17.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,390 mg/kg bw/day,,rat "1,3-bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione",6440-58-0,DMDMH readily undergoes hydrolysis to DMH and therefore data is provided for both substances. DMDMH is of low to moderate acute toxicity and DMH is of low acute toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4247d81-db63-460e-ae47-5abf6fbc9cde/documents/IUC5-33ef15ed-63f2-4011-b247-225ae501ddec_4c8f577e-99cc-4e2d-920e-bcb6b0345b17.html,,,,,, "1,3-bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione",6440-58-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4247d81-db63-460e-ae47-5abf6fbc9cde/documents/IUC5-33ef15ed-63f2-4011-b247-225ae501ddec_4c8f577e-99cc-4e2d-920e-bcb6b0345b17.html,,oral,LD50,"1,572 mg/kg bw",adverse effect observed, "1,3-bis(hydroxymethyl)-5,5-dimethylimidazolidine-2,4-dione",6440-58-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4247d81-db63-460e-ae47-5abf6fbc9cde/documents/IUC5-33ef15ed-63f2-4011-b247-225ae501ddec_4c8f577e-99cc-4e2d-920e-bcb6b0345b17.html,,dermal,LD50,"1,052 mg/kg bw",no adverse effect observed, Dimethyl sulfoxide,67-68-5,"DMSO is of low toxicity by repeated administration. In a 13-week inhalation toxicity study, the NOAEC could be established at ca. 1.0 mg/l for respiratory tract irritation and ca. 2.8 mg/l (the highest concentration tested) for systemic toxicity. Other repeated dose toxicity studies performed by different routes of administration and with several mammalian species have also shown that DMSO produced only slight systemic toxicity. With the exception of a decrease of the body weight gain and some hematological effects (which could be secondary to an increased diuresis) at very high dose levels, the most common finding observed in these studies is changes of the refractive power of the lens. Species in which such lens alterations readily develop include the rat, rabbit, dog and pig, while primates are not sensitive. Clinical signs of systemic toxicity and the alterations of the lens have never been observed or reported in clinical and epidemiological studies performed in humans, even after exposure to high dose level (1000 mg/kg/d for 3 months) or for a long period of time (up to 19 months). The NOAELs by oral and dermal routes in primates are 2970 and 8910 mg/kg bw/d, respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fe46e0d-17b0-4f33-bc16-5b2a86afb8a1/documents/334f8ab8-451a-4b9d-9214-df1d66e5ccd1_28f0d32d-abc0-4b9d-b4d3-08ca7dc354fb.html,,,,,, Dimethyl sulfoxide,67-68-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fe46e0d-17b0-4f33-bc16-5b2a86afb8a1/documents/334f8ab8-451a-4b9d-9214-df1d66e5ccd1_28f0d32d-abc0-4b9d-b4d3-08ca7dc354fb.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"2,800 mg/m3",,rat Dimethyl sulfoxide,67-68-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fe46e0d-17b0-4f33-bc16-5b2a86afb8a1/documents/334f8ab8-451a-4b9d-9214-df1d66e5ccd1_28f0d32d-abc0-4b9d-b4d3-08ca7dc354fb.html,Chronic toxicity – systemic effects,oral,NOAEL,"2,970 mg/kg bw/day",,monkey Dimethyl sulfoxide,67-68-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fe46e0d-17b0-4f33-bc16-5b2a86afb8a1/documents/334f8ab8-451a-4b9d-9214-df1d66e5ccd1_28f0d32d-abc0-4b9d-b4d3-08ca7dc354fb.html,Chronic toxicity – systemic effects,dermal,NOAEL,"8,910 mg/kg bw/day",,monkey Dimethyl sulfoxide,67-68-5,"The acute inhalation toxicity of DMSO in rats has been investigated in studies compliant with OECD guidelines and also in non-guideline studies. For the oral and dermal routes, only non-guideline studies are available. DMSO is of low acute toxicity. In non-guideline studies, LD50 in rats are generally higher than 20,000 mg/kg bw and 40,000 mg/kg bw by the oral and dermal routes, respectively. In an acute inhalation study performed following the OECD guideline # 403, the 4h-LC50 in rats was higher than 5330 mg/m3. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fe46e0d-17b0-4f33-bc16-5b2a86afb8a1/documents/7cb331b8-2809-4507-96ad-a59704dd3558_28f0d32d-abc0-4b9d-b4d3-08ca7dc354fb.html,,,,,, Dimethyl sulfoxide,67-68-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fe46e0d-17b0-4f33-bc16-5b2a86afb8a1/documents/7cb331b8-2809-4507-96ad-a59704dd3558_28f0d32d-abc0-4b9d-b4d3-08ca7dc354fb.html,,oral,LD50,"28,300 mg/kg bw",, Dimethyl sulfoxide,67-68-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fe46e0d-17b0-4f33-bc16-5b2a86afb8a1/documents/7cb331b8-2809-4507-96ad-a59704dd3558_28f0d32d-abc0-4b9d-b4d3-08ca7dc354fb.html,,dermal,LD50,"40,000 mg/kg bw",, Dimethyl sulfoxide,67-68-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fe46e0d-17b0-4f33-bc16-5b2a86afb8a1/documents/7cb331b8-2809-4507-96ad-a59704dd3558_28f0d32d-abc0-4b9d-b4d3-08ca7dc354fb.html,,inhalation,discriminating conc.,"5,330 mg/m3",, Docosane,629-97-0," No key or supporting data is available for docosane. However, key repeated dose oral toxicity data in rats is available from a structurally related substance, C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) and is presented below: 90 day repeated dose oral toxicity study in the rat: - treatment-related effects in animals of either sex treated with 1000 and 200 mg/Kg/day - no such effects were detected in animals of either sex treated with 50 mg/Kg/day and the “No Observed Effect Level” (NOEL) was, therefore, considered to be 50 mg/Kg/day. - the effects detected at 200 and 1000 mg/Kg/day in the lungs and mesenteric lymph nodes were considered to be secondary to aspiration following the oral gavage and a normal response of the lymph nodes clearing the material, respectively, and were therefore not considered to be an adverse effect of treatment; the “No Observed Adverse Effect Level” (NOAEL) was therefore considered to be 1000 mg/Kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/52700ef1-ab4f-4154-81a3-5dc9a5cc705d/documents/387c90e9-1b58-4a2a-bc6e-22e14e805bc5_3caccabd-2c5f-416b-a735-668c4fd6b36c.html,,,,,, Docosane,629-97-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/52700ef1-ab4f-4154-81a3-5dc9a5cc705d/documents/387c90e9-1b58-4a2a-bc6e-22e14e805bc5_3caccabd-2c5f-416b-a735-668c4fd6b36c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Docosane,629-97-0," No acute oral, dermal, or inhalation toxicity data is available for docosane. However, key oral toxicity and supporting dermal and inhalation toxicity data is available from structurally related substances, C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) and C8-C26 branched and linear hydrocarbons – Distillates (CAS# 848301-67-7) and is presented below. 1) Acute oral toxicity: The acute oral median lethal dose (LD50) of C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) in the female Sprague-Dawley CD strain rat was estimated to be greater than 5000 mg/kg bodyweight. 2) Acute inhalation and dermal toxicity: Based on lack of skin irritation and systemic effects in a read across skin irritation study, docosane is not considered to be acutely harmful in contact with skin. Moreover, the substance is unlikely to form aerosols or particles of inhalable size. Therefore it is considered justifiable not to conduct these studies. Supporting data on a related substance C8-C26 branched and linear hydrocarbons – Distillates (CAS# 848301-67-7) indicate the low dermal and inhalation toxicity: a) Acute inhalation toxicity study (Shell, 2013a), conducted according to OECD 436 and GLP, reported an acute inhalation median lethal concentration (4 hr LC50) of Distillates (Fischer-Tropsch), C8-26-branched and linear, in the RccHanTM: WIST strain rat >5 mg/L. b) Acute dermal toxicity study (Shell, 2015a), conducted according to OECD 402 (Acute Dermal Toxicity) and GLP, reported an LD50 in male and female rats >2000 mg/Kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52700ef1-ab4f-4154-81a3-5dc9a5cc705d/documents/842a551c-2966-4184-8a71-747dcde84f9d_3caccabd-2c5f-416b-a735-668c4fd6b36c.html,,,,,, Docosane,629-97-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52700ef1-ab4f-4154-81a3-5dc9a5cc705d/documents/842a551c-2966-4184-8a71-747dcde84f9d_3caccabd-2c5f-416b-a735-668c4fd6b36c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Docosane,629-97-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52700ef1-ab4f-4154-81a3-5dc9a5cc705d/documents/842a551c-2966-4184-8a71-747dcde84f9d_3caccabd-2c5f-416b-a735-668c4fd6b36c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Docosane,629-97-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52700ef1-ab4f-4154-81a3-5dc9a5cc705d/documents/842a551c-2966-4184-8a71-747dcde84f9d_3caccabd-2c5f-416b-a735-668c4fd6b36c.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "[3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan",6790-58-5,"Read-across on racemic form of Cycloalkane ethers: Combined repeated dose toxicity study with the reproduction/development toxicity screening test: NOAEL = 800 mg/kg bw/day (OECD 422, GLP, rel. 1) 90-day repeated dose toxicity study by oral gavage administration in rats: NOAEL = 100 mg/kg bw/day based on increased body weight-adjusted liver weights apparent for both sexes at 400 or 800 mg/kg bw/day (OECD 408, GLP, rel. 1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The key study is GLP-compliant and of high quality (Klimisch score = 1) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e60aa137-d779-43d2-b78c-6535ed8a6c04/documents/IUC5-bd9b382d-c26a-4ecd-a95a-bd9d1fe58a4d_5d7069ea-6a09-43ea-961c-9245e8ea62cc.html,,,,,, "[3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan",6790-58-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e60aa137-d779-43d2-b78c-6535ed8a6c04/documents/IUC5-bd9b382d-c26a-4ecd-a95a-bd9d1fe58a4d_5d7069ea-6a09-43ea-961c-9245e8ea62cc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "[3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan",6790-58-5,"Acute toxicity: oral: LD50 > 2000 mg/kg bw (OECD 401 in rats and mice; WoE, rel.2 and read-across, OECD 420, GLP, WoE, rel. 1);Acute toxicity: dermal: LD50 > 2000 mg/kg bw (similar to OECD 402, K, rel. 2);Acute toxicity: inhalation: waiver. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The two studies performed on the registered substance in rats and mice were non-GLP, but followed or were similar to OECD Test guideline No 401. The study performed on the source substance was performed according to OECD test guideline No. 420 and in compliance with GLP. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): In the key study, conducted under worst-case conditions (abraded skin, occlusive dressing), no mortality was observed. An additional dermal study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover this endpoint. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e60aa137-d779-43d2-b78c-6535ed8a6c04/documents/IUC5-76600ad9-c07b-472b-9df8-493a1a9924a4_5d7069ea-6a09-43ea-961c-9245e8ea62cc.html,,,,,, "[3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan",6790-58-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e60aa137-d779-43d2-b78c-6535ed8a6c04/documents/IUC5-76600ad9-c07b-472b-9df8-493a1a9924a4_5d7069ea-6a09-43ea-961c-9245e8ea62cc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "[3aR-(3aα,5aβ,9aα,9bβ)]-dodecahydro-3a,6,6,9a-tetramethylnaphtho[2,1-b]furan",6790-58-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e60aa137-d779-43d2-b78c-6535ed8a6c04/documents/IUC5-76600ad9-c07b-472b-9df8-493a1a9924a4_5d7069ea-6a09-43ea-961c-9245e8ea62cc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dodecane,112-40-3,Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test – NOAEL ≥ 1000 mg/kg for rats (OECD 422)   Repeated Dose Oral 90d - NOAEL ≥ 5000 mg/kg bw/day for rats (OECD 408)   Repeated Dose Inhalation 90d – NOAEC ≥ 10400 mg/m3 for rats (similar to OECD TG 413) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3bc52e9-c78e-4649-9eef-33d361cdde54/documents/9272b9a3-d8da-451a-ac7b-3bab06fcddf9_208c3ac0-814c-457f-93ba-37fc4f69f574.html,,,,,, Dodecane,112-40-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3bc52e9-c78e-4649-9eef-33d361cdde54/documents/9272b9a3-d8da-451a-ac7b-3bab06fcddf9_208c3ac0-814c-457f-93ba-37fc4f69f574.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat Dodecane,112-40-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3bc52e9-c78e-4649-9eef-33d361cdde54/documents/9272b9a3-d8da-451a-ac7b-3bab06fcddf9_208c3ac0-814c-457f-93ba-37fc4f69f574.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,">= 5,000 mg/kg bw/day",,rat Dodecane,112-40-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3bc52e9-c78e-4649-9eef-33d361cdde54/documents/9272b9a3-d8da-451a-ac7b-3bab06fcddf9_208c3ac0-814c-457f-93ba-37fc4f69f574.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"10,400 mg/m3",,rat Dodecane,112-40-3,Acute Toxicity-Oral LD50 > 5000 mg/kg in rats (OECD TG 401)   Acute Toxicity-Inhalation LC50 > 6100 mg/m3 (OECD TG 403)   Acute Toxicity-Dermal LD50 > 3160 mg/kg in rabbits (OECD TG 402) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3bc52e9-c78e-4649-9eef-33d361cdde54/documents/759c3bed-7779-47c1-a518-f5144d9cf4d5_208c3ac0-814c-457f-93ba-37fc4f69f574.html,,,,,, Dodecane,112-40-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3bc52e9-c78e-4649-9eef-33d361cdde54/documents/759c3bed-7779-47c1-a518-f5144d9cf4d5_208c3ac0-814c-457f-93ba-37fc4f69f574.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Dodecane,112-40-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3bc52e9-c78e-4649-9eef-33d361cdde54/documents/759c3bed-7779-47c1-a518-f5144d9cf4d5_208c3ac0-814c-457f-93ba-37fc4f69f574.html,,dermal,LD50,"3,160 mg/kg bw",no adverse effect observed, Dodecane,112-40-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3bc52e9-c78e-4649-9eef-33d361cdde54/documents/759c3bed-7779-47c1-a518-f5144d9cf4d5_208c3ac0-814c-457f-93ba-37fc4f69f574.html,,inhalation,LC50,"6,100 mg/m3",no adverse effect observed, Dodecanedioic acid,693-23-2,A 90-day oral gavage repeated dose study in rats showed no adverse effects up to dose levels of 1800 mg/kg bw/d.A 14-day oral gavage repeated dose study in rats showed no adverse effects up to dose levels of 2400 mg/kg bw/d.A 50-day oral combined repeated dose and reproductive toxicity study in rats showed no adverse effects up to dose levels of 1000 mg/kg bw/d. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfd8046d-d9f0-463e-8474-06e2e15aa6fd/documents/IUC5-88261b79-8c74-4672-be02-e9ebf141923f_a36364a1-9bd6-42f9-a7a7-b3ed733b74fa.html,,,,,, Dodecanedioic acid,693-23-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfd8046d-d9f0-463e-8474-06e2e15aa6fd/documents/IUC5-88261b79-8c74-4672-be02-e9ebf141923f_a36364a1-9bd6-42f9-a7a7-b3ed733b74fa.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,800 mg/kg bw/day",,rat Dodecanedioic acid,693-23-2,Experimental studies on oral and dermal acute toxicity are available. Dodecanedioic Acid has very low toxicity upon acute exposure. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfd8046d-d9f0-463e-8474-06e2e15aa6fd/documents/IUC5-d41cc603-5e6d-43f7-925e-4627a8fccaae_a36364a1-9bd6-42f9-a7a7-b3ed733b74fa.html,,,,,, Dodecanedioic acid,693-23-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfd8046d-d9f0-463e-8474-06e2e15aa6fd/documents/IUC5-d41cc603-5e6d-43f7-925e-4627a8fccaae_a36364a1-9bd6-42f9-a7a7-b3ed733b74fa.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, Dodecanedioic acid,693-23-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfd8046d-d9f0-463e-8474-06e2e15aa6fd/documents/IUC5-d41cc603-5e6d-43f7-925e-4627a8fccaae_a36364a1-9bd6-42f9-a7a7-b3ed733b74fa.html,,dermal,LD50,"6,000 mg/kg bw",no adverse effect observed, Dodecanenitrile,2437-25-4,"Repeated dose toxicity: oral  Based on the available study data it was observed that the NOAEL value of the test substance Dodecanentirile (2437-25-4) was 250 mg/kg bw/day in male and female rats by oral route for 47 days repeated dose study. thus as per the CLP criteria the test substance was found to be not classified for repeated dose toxicity study   Repeated dose toxicity: inhalation Dodecanentirile is a closed-system intermediate; therefore, little to no exposure to workers is expected because the reaction vessels used to manufacture this material are part of multipurpose, closed-system operation. The data provided herein are being submitted in accordance with the U.S. Environmental Protection Agency's interpretation of Section 8(e) of the Toxic Substances Control Act (TSCA).Also, given the use of the chemical as cleanser or washing purpose. Therefore repeated exposure by the inhalation route is unlikely since the use of respiratory mask is common practice in industries. Thus, it is expected that Dodecanentirile shall not exhibit 28 day repeated dose toxicity by the inhalation route. In addition, there is no data available that suggests that Dodecanentirile (2437-25-4) shall exhibit repeated dose toxicity by the inhalation route. Hence this end point was considered for waiver.   Repeated dose toxicity: dermal The acute toxicity value for Dodecanentirile (as provided in section 7.2.3) is 4230.6mg/kg body weight. Also, given the use of the chemical as a closed-system intermediate; therefore, little to no exposure to workers is expected because the reaction vessels used to manufacture this material are part of multipurpose, closed-system operation. The data provided herein are being submitted in accordance with the U.S. Environmental Protection Agency's interpretation of Section 8(e) of the Toxic Substances Control Act (TSCA). Therefore repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that Dodecanentirile (2437-25-4) shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Dodecanentirile (2437-25-4) shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82d5f68a-50e1-407f-9760-19e252da5b7b/documents/da31340e-b455-4ee7-90c7-6b200541097d_475935fc-8606-4803-9143-ca215b7726fa.html,,,,,, Dodecanenitrile,2437-25-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82d5f68a-50e1-407f-9760-19e252da5b7b/documents/da31340e-b455-4ee7-90c7-6b200541097d_475935fc-8606-4803-9143-ca215b7726fa.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,567.036 mg/kg bw/day,,rat Dodecanenitrile,2437-25-4,"Data available for the structurally similar read across chemicals has been reviewed to determine the Acute toxicity of the test chemical. Acute oral toxicity: Acute oral toxicity study of Dodecanenitrile (CAS No. 2437-25-4) in rat .This study was performed as per - OECD Guideline 401 (Acute Oral Toxicity) .The LD50 value is 3400 mg/kg bw.   Acute inhalation toxicity: The acute inhalation toxicity Study of 1-tridecanol (CAS no.112-70-9) in rats .(LC50) was considered to be >12 ppm (>12000 mg/m3), when rats were exposed with the given test chemical via inhalation route for 6 hours.   Acute Dermal toxicity: The Acute Dermal toxicity of 1-tridecanol (CAS no.112-70-9) ,the dose (LD50) was considered to be 7070 mg/kg bw, with 95% confidence limit of 2330-21400 mg/kg bw, when Group 4 male New Zealand rabbits were treated with test chemical by dermal application occlusively to the clipped skin.   Based on the above values and comparing it with CLP classification criteria it can be concluded that the substance Dodecanenitrile is not toxic via oral, inhalation and dermal route of administration and considered as Not classified.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82d5f68a-50e1-407f-9760-19e252da5b7b/documents/dd66041e-016c-418f-b69c-d192698c63a0_475935fc-8606-4803-9143-ca215b7726fa.html,,,,,, Dodecanenitrile,2437-25-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82d5f68a-50e1-407f-9760-19e252da5b7b/documents/dd66041e-016c-418f-b69c-d192698c63a0_475935fc-8606-4803-9143-ca215b7726fa.html,,oral,LD50,"3,400 mg/kg bw",no adverse effect observed, Dodecanenitrile,2437-25-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82d5f68a-50e1-407f-9760-19e252da5b7b/documents/dd66041e-016c-418f-b69c-d192698c63a0_475935fc-8606-4803-9143-ca215b7726fa.html,,dermal,LD50,"> 2,600 mg/kg bw",no adverse effect observed, Dodecanenitrile,2437-25-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82d5f68a-50e1-407f-9760-19e252da5b7b/documents/dd66041e-016c-418f-b69c-d192698c63a0_475935fc-8606-4803-9143-ca215b7726fa.html,,inhalation,LC50,"> 120,003 mg/m3",no adverse effect observed, Dodec-1-ene,112-41-4," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea6e7692-acf3-4278-b9d4-c9e5df918570/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_b8fc4db6-9068-44ff-85c4-310a74a10dcf.html,,,,,, Dodec-1-ene,112-41-4,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea6e7692-acf3-4278-b9d4-c9e5df918570/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_b8fc4db6-9068-44ff-85c4-310a74a10dcf.html,,,,,, Dodecylbenzenesulphonic acid,27176-87-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b86b01ed-7437-49ae-a0ad-a810157316ec/documents/IUC5-276584f1-ed7e-4650-945c-886f7a133a0b_29bb8615-77a2-41c1-aa3b-3cbe9785a552.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Dodecylbenzenesulphonic acid,27176-87-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b86b01ed-7437-49ae-a0ad-a810157316ec/documents/IUC5-276584f1-ed7e-4650-945c-886f7a133a0b_29bb8615-77a2-41c1-aa3b-3cbe9785a552.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,286 mg/kg bw/day,,rat Dodecylbenzenesulphonic acid,27176-87-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b86b01ed-7437-49ae-a0ad-a810157316ec/documents/IUC5-276584f1-ed7e-4650-945c-886f7a133a0b_29bb8615-77a2-41c1-aa3b-3cbe9785a552.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,4.35 mg/m3,,rat Dodecylbenzenesulphonic acid,27176-87-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b86b01ed-7437-49ae-a0ad-a810157316ec/documents/IUC5-276584f1-ed7e-4650-945c-886f7a133a0b_29bb8615-77a2-41c1-aa3b-3cbe9785a552.html,Repeated dose toxicity – local effects,dermal,NOAEL,1.6 mg/cm2,no adverse effect observed,rat Dodecylbenzenesulphonic acid,27176-87-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b86b01ed-7437-49ae-a0ad-a810157316ec/documents/IUC5-276584f1-ed7e-4650-945c-886f7a133a0b_29bb8615-77a2-41c1-aa3b-3cbe9785a552.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4.35 mg/m3,no adverse effect observed,rat Dodecylbenzenesulphonic acid,27176-87-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b86b01ed-7437-49ae-a0ad-a810157316ec/documents/IUC5-51b06533-ec79-47fa-8c9e-54207770bf7a_29bb8615-77a2-41c1-aa3b-3cbe9785a552.html,,oral,LD50,650 mg/kg bw,adverse effect observed, Dodecylbenzenesulphonic acid,27176-87-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b86b01ed-7437-49ae-a0ad-a810157316ec/documents/IUC5-51b06533-ec79-47fa-8c9e-54207770bf7a_29bb8615-77a2-41c1-aa3b-3cbe9785a552.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dodecylbenzenesulphonic acid,27176-87-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b86b01ed-7437-49ae-a0ad-a810157316ec/documents/IUC5-51b06533-ec79-47fa-8c9e-54207770bf7a_29bb8615-77a2-41c1-aa3b-3cbe9785a552.html,,inhalation,LC50,310 mg/m3,no adverse effect observed, "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.",85536-14-7," Repeated dose toxicity studies were conducted through oral route in rats (Yoneyama 1976 a, Yoneyama 1972; Ito 1978 a, b, c; Oser 1965; study 1 - 6 in CSR) and mice (Yoneyama 1976 b, study 7 CSR) and through dermal route in rats (Ito 1978 b) and through subcutaneous route in monkeys (Heywood 1978). One oral study was performed with C10-13 LAS Na (Ito 1978a), two oral studies were performed with C10-13 LAS Mg (Ito 1978b and c) and four oral studies were performed with C10-14 LAS Na (Yoneyama 1976 a and b, Yoneyama 1972 and Oser 1965). The dermal study was performed with C10-13 LAS Mg (Ito 1978 d). C10-13 LAS Mg and C10-13 LAS Na are considered to be a similar substance as C10-13 LAS H as they all disassociate in vivo to form the identical LAS anion.   C10-14 LAS Na (source substance) has very similar composition to C10-13 LAS (target substance). Therefore read-across is considered to be acceptable. The target and source substance only differ slightly in the C10 and C14 content. The substances present a similar potency of toxicological behaviour with respect to acute oral toxicity, with LD50 being 1080 mg/kg bw for the target substance and 900 mg/kg bw for the source substance. With respect to repeated dose endpoint, for the studies available on the source and target substances, the doses at which effects were observed were similar (after consideration of exposure route and dose spacing) as were the observed effects.  For dietary exposures, LOAELs ranged from 300 to 500 for source and target substances, respectively. In both substances, the significant secondary effects observed at higher doses were similar. For the key studies available for the source substance, no significant effects in liver and kidneys were observed at the NOAELs of 40 mg/kg bw/day and 85 mg/kg bw/day. The consistency in the adverse effects seen in liver and kidneys in both studies supports the selection of 85 mg/kg bw/day as the appropriate NOAEL.   For the target substance, the supporting (limited) study by the same route resulted in a NOAEL of 150 mg/kg/day. Therefore, there is no evidence in the available data set that there are significant differences in potency between the source and target substances. In addition, use of data from the source substance represents an overall conservative approach in terms of the quantitative aspects of the repeated dose toxicity of these substances. In conclusion, considering the entire dataset, the highest NOAEL for systemic toxicity below the lowest LOAEL (115 mg/kg bw/day from the 26 weeks dietary study with C10-14 LAS Na in rats, Yoneyama 1972, based on histopathological changes in liver and kidney) is 85 mg/kw bw/day from the 9 months drinking water study in rats with C10-14 LAS Na (Yoneyama 1976 a). In this drinking water study, the LOAEL was slightly higher at 145 mg/kg bw/day and based on liver and kidney enzyme changes. The consistency in the adverse effects seen in liver and kidneys in these studies (i.e. Yoneyama 1976 and Yoneyama 1972) supports the selection of 85 mg/kg bw/day as the appropriate NOAEL. Further, the selection of 85 mg/ kg bw/day as the appropriate NOAEL is also supported by the higher NOAEL of 150 mg/kg bw/day observed in the 26 weeks oral gavage study in rats with C10-13 LAS Mg (Ito 1978 b). Therefore, based on the entire data set, the point of departure taken forward for risk assessment purposes is the NOAEL of 85 mg/kg bw/day.   For dermal exposure, the systemic toxicity NOAEL was established at 5.0% (equivalent to 2500 mg/kg bw/day), based on no toxicologically relevant changes at any dose level in a sub-chronic 26 -weeks dermal repeated dose toxicity study with C10-13 LAS Mg in rats (Ito 1978 d). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91a7d2b8-c39c-4326-be80-32719e7a790a/documents/16a08150-db25-4f8a-966f-9e19c1571e13_c7e2a832-c6ec-4736-94df-5adfd18e739e.html,,,,,, "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.",85536-14-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91a7d2b8-c39c-4326-be80-32719e7a790a/documents/16a08150-db25-4f8a-966f-9e19c1571e13_c7e2a832-c6ec-4736-94df-5adfd18e739e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,85 mg/kg bw/day,,rat "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.",85536-14-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91a7d2b8-c39c-4326-be80-32719e7a790a/documents/16a08150-db25-4f8a-966f-9e19c1571e13_c7e2a832-c6ec-4736-94df-5adfd18e739e.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,500 mg/kg bw/day",,rat "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.",85536-14-7," Oral toxicity of LAB Sulfonic Acid was examined in rats. Groups of 5 male and 5 female rats were exposed orally to 0, 1250, 1415, 1580, or 1990 mg/kg bw of LAB Sulfonic Acid. The animals were then monitored for 14 days for mortality and clinical signs. Body weights were measured on days 7 and 14, and necropsies were performed at the end of the study. Within approximately 30 minutes of application, symptoms observed included dry skin, diarrhea, squatting attitude, small dark red eyes, ataxia, hypothermia, diuresis, occasional trembling, tumbling, and prone position. Nine animals in the 1580 and 1990 mg/kg doses died. In the other doses, the number of animals that died were 0 and 3 of 10 for the 1250 and 1415 mg/kg doses, respectively. Post mortem sections showed strong hyperemias and swelling, as well as partial damage to the stomach and intestinal mucosae. Also, effects to the stomach, liver, and peritoneum were seen. The tissue sections showed swelling of the gastric mucosa in 3 animals, as well as the growing together of organs of the abdominal cavity with the diaphragm in 2 animals. The resulting LD50value was 1470 mg/kg bw. Based on the results of the acute oral toxicity study, LAB Sulfonic Acid is classified Category 4, harmful if swallowed according to the CLP directive. No study is required for inhalation exposure (data waiving). In accordance with column 2 of REACH Annex VIII-X, in addition to the oral route, for substances other than gases, an acute toxicity study for at least one other route is required. The choice of the second route will depend on the nature of the substance and the likely route of human exposure. As dermal is the most likely route of exposure and acute dermal toxicity data are available, no data gap for inhalation exposure exists. Dermal toxicity was examined in a study on LAS (read across). The clipped skin on the backs (approximate 10% of the area) of five male and five female rats were exposed to a dose of 2000 mg/kg LAS (read across) and kept under an occlusive dressing for 24 hours, then observed for another 14 days after the dressing was removed and the skin washed in warm water. The treated areas were examined daily for signs of dermal irritation and assessed according to the standard scoring system for erythema, eschar and oedema. On day 15 all animals were sacrificed and given a macroscopic post-mortem examination of internal organs. No mortality was observed at exposures to 2000 mg/kg of the undiluted test material. There were no signs of systemic reaction. Well defined or slight erythema and slight oedema were observed at all test sites after removal of the occlusive dressings, and these reactions were unresolved before progressive hardening of the skin was first detected on day 4. All test sites were entirely covered by scab formation from day 7. Sloughing from the scabbed skin began at various times between day 7 and day 12 and was completed before test termination. Therefore, results indicate slight erythema and slight oedema but no acute mortality. The dermal LD50 is > 2000 mg/kg and LAS (read across) is not classified for acute dermal toxicity under CLP. The acute toxicity of LAB Sulfonic Acid was examined via both the oral (LAB Sulfonic Acid) and dermal (LAS, read-across) routes. Based on the results of the acute oral toxicity study, LAB Sulfonic Acid is classified Category 4, harmful if swallowed according to the CLP directive. The dermal LD50 is > 2000 mg/kg and LAS (read across) is not classified for acute dermal toxicity under CLP. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91a7d2b8-c39c-4326-be80-32719e7a790a/documents/8c9edbba-0534-432c-9fd7-a673b44db1e5_c7e2a832-c6ec-4736-94df-5adfd18e739e.html,,,,,, "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.",85536-14-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91a7d2b8-c39c-4326-be80-32719e7a790a/documents/8c9edbba-0534-432c-9fd7-a673b44db1e5_c7e2a832-c6ec-4736-94df-5adfd18e739e.html,,oral,LD50,"1,470 mg/kg bw",adverse effect observed, "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.",85536-14-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91a7d2b8-c39c-4326-be80-32719e7a790a/documents/8c9edbba-0534-432c-9fd7-a673b44db1e5_c7e2a832-c6ec-4736-94df-5adfd18e739e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-(2H-benzotriazol-2-yl)-p-cresol,2440-22-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c3d9361-528e-4ae1-97de-8b3e20be64c6/documents/a31a1828-1e56-4bce-af26-9d92bb9d7660_4a72405a-2336-4019-b116-5ff3cfd6ab0a.html,Chronic toxicity – systemic effects,oral,NOAEL,47 mg/kg bw/day,,rat 2-(2H-benzotriazol-2-yl)-p-cresol,2440-22-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c3d9361-528e-4ae1-97de-8b3e20be64c6/documents/24c29de2-0fca-4a5a-bbac-d3d072763130_4a72405a-2336-4019-b116-5ff3cfd6ab0a.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, 2-(2H-benzotriazol-2-yl)-p-cresol,2440-22-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c3d9361-528e-4ae1-97de-8b3e20be64c6/documents/24c29de2-0fca-4a5a-bbac-d3d072763130_4a72405a-2336-4019-b116-5ff3cfd6ab0a.html,,inhalation,discriminating conc.,590 mg/m3,adverse effect observed, Edetic acid,60-00-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37f71285-c428-4fc9-9c0b-3b0f42ce07a9/documents/IUC5-a77c0220-4528-4778-a122-f83dce7d5785_9b845c35-39b5-4f3c-9d56-36e30f8be713.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Edetic acid,60-00-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37f71285-c428-4fc9-9c0b-3b0f42ce07a9/documents/IUC5-c94bb6db-c05d-4e1c-ab02-acf8fa3185b4_9b845c35-39b5-4f3c-9d56-36e30f8be713.html,,oral,LD50,"4,500 mg/kg bw",, Icosane,112-95-8, Repeated Dose Oral 90d - NOAEL ≥ 500 mg/kg bw/day for rats (OECD 408); BMDL = 1857 mg/Kg bw/day. Repeated Dose Inhalation 90d – NOAEC ≥ 6000 mg/m3 for rats (similar to OECD TG 413) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c630e68d-e2d3-4000-88b7-33121a140c96/documents/9712027c-182b-4c02-8ac3-355fa8b74446_1816d25b-eae9-4afa-9190-6edd56bab4f6.html,,,,,, Icosane,112-95-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c630e68d-e2d3-4000-88b7-33121a140c96/documents/9712027c-182b-4c02-8ac3-355fa8b74446_1816d25b-eae9-4afa-9190-6edd56bab4f6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Icosane,112-95-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c630e68d-e2d3-4000-88b7-33121a140c96/documents/9712027c-182b-4c02-8ac3-355fa8b74446_1816d25b-eae9-4afa-9190-6edd56bab4f6.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"6,000 mg/m3",,rat Icosane,112-95-8, Oral LD50 (rat) > 5000 mg/Kg bw   Inhalation LC50 (rat) >5991 mg/m³   Dermal LD50 (rabbit) > 2000 mg/Kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c630e68d-e2d3-4000-88b7-33121a140c96/documents/9fcf4d05-fe50-4b48-85a4-773691a19b28_1816d25b-eae9-4afa-9190-6edd56bab4f6.html,,,,,, Icosane,112-95-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c630e68d-e2d3-4000-88b7-33121a140c96/documents/9fcf4d05-fe50-4b48-85a4-773691a19b28_1816d25b-eae9-4afa-9190-6edd56bab4f6.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Icosane,112-95-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c630e68d-e2d3-4000-88b7-33121a140c96/documents/9fcf4d05-fe50-4b48-85a4-773691a19b28_1816d25b-eae9-4afa-9190-6edd56bab4f6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Icosane,112-95-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c630e68d-e2d3-4000-88b7-33121a140c96/documents/9fcf4d05-fe50-4b48-85a4-773691a19b28_1816d25b-eae9-4afa-9190-6edd56bab4f6.html,,inhalation,LC50,"5,991 mg/m3",no adverse effect observed, "Cardamom, ext.",85940-32-5,"Acute toxicity, oral: LD50 = ca. 5000 mg/kg bw (K, Rel.2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b63d4f3e-c745-4247-aa34-61a3d52dabbc/documents/IUC5-b78a5898-a8b5-4671-92db-3194f194729e_96a2950f-3f83-4dd8-8222-c245b71f3271.html,,,,,, "Cardamom, ext.",85940-32-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b63d4f3e-c745-4247-aa34-61a3d52dabbc/documents/IUC5-b78a5898-a8b5-4671-92db-3194f194729e_96a2950f-3f83-4dd8-8222-c245b71f3271.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "1-chloro-2,3-epoxypropane",106-89-8,"In carcinogenicity studies and subchronic studies, histopathologic changes were noted at the site of entry following oral or inhalation administration, thus histopathologic changes were observed in the stomach following oral administration and nasal turbinates following inhalation exposure to vapors. In addition, some slight histologic changes were observed in the liver and kidneys following both oral and inhalation exposure for 90 days; these occured at the same or higher doses than the portal of entry effects. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a389aa2-3b75-4d26-bc62-ccfdffa665a2/documents/2a5c2ba8-b322-481b-8ae7-14aba49840ca_9f3fd57c-4935-4fe8-b0d9-07339da50668.html,,,,,, "1-chloro-2,3-epoxypropane",106-89-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a389aa2-3b75-4d26-bc62-ccfdffa665a2/documents/2a5c2ba8-b322-481b-8ae7-14aba49840ca_9f3fd57c-4935-4fe8-b0d9-07339da50668.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,1 mg/kg bw/day,,rat "1-chloro-2,3-epoxypropane",106-89-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a389aa2-3b75-4d26-bc62-ccfdffa665a2/documents/2a5c2ba8-b322-481b-8ae7-14aba49840ca_9f3fd57c-4935-4fe8-b0d9-07339da50668.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,95 mg/m3,,rat "1-chloro-2,3-epoxypropane",106-89-8," Using the GHS classification system, epichlorohydrin is a Category 3 following oral, dermal and inhalation exposure. KJB 05/10/2018. The acute inhalation classification was corrected from category 2 to category 3 in 7.2.2 in Applicants summary and conclusion section. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a389aa2-3b75-4d26-bc62-ccfdffa665a2/documents/4f16752c-32eb-456c-9544-b1977496d3e7_9f3fd57c-4935-4fe8-b0d9-07339da50668.html,,,,,, "1-chloro-2,3-epoxypropane",106-89-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a389aa2-3b75-4d26-bc62-ccfdffa665a2/documents/4f16752c-32eb-456c-9544-b1977496d3e7_9f3fd57c-4935-4fe8-b0d9-07339da50668.html,,oral,LD50,175 mg/kg bw,adverse effect observed, "1-chloro-2,3-epoxypropane",106-89-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a389aa2-3b75-4d26-bc62-ccfdffa665a2/documents/4f16752c-32eb-456c-9544-b1977496d3e7_9f3fd57c-4935-4fe8-b0d9-07339da50668.html,,dermal,LD50,515 mg/kg bw,adverse effect observed, "1-chloro-2,3-epoxypropane",106-89-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a389aa2-3b75-4d26-bc62-ccfdffa665a2/documents/4f16752c-32eb-456c-9544-b1977496d3e7_9f3fd57c-4935-4fe8-b0d9-07339da50668.html,,inhalation,LC50,"4,114 mg/m3",adverse effect observed, "Soybean oil, epoxidized",8013-07-8,A combined repeated dose toxicity with the reproduction/developmental toxicity screening test was carried out on rats according to OECD test guideline 422. A combined chronic toxicity/carcinogenicity study was carried out according to OECD test guideline 453. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c6b4ed6-c363-417d-bcb4-948bf4d0805c/documents/IUC5-2ff20ddd-4765-4f08-866c-96d44a6b46d2_67505c88-110b-4e90-8c8c-9b32f4fa3797.html,,,,,, "Soybean oil, epoxidized",8013-07-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c6b4ed6-c363-417d-bcb4-948bf4d0805c/documents/IUC5-2ff20ddd-4765-4f08-866c-96d44a6b46d2_67505c88-110b-4e90-8c8c-9b32f4fa3797.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Soybean oil, epoxidized",8013-07-8,The acute oral toxicity was observed in five male and five female rats over a period of 14 days. The LD50 was found to be greater than 5000 mg/kg. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c6b4ed6-c363-417d-bcb4-948bf4d0805c/documents/IUC5-171a4707-f931-43cc-bb22-146b69413c0f_67505c88-110b-4e90-8c8c-9b32f4fa3797.html,,,,,, "Soybean oil, epoxidized",8013-07-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c6b4ed6-c363-417d-bcb4-948bf4d0805c/documents/IUC5-171a4707-f931-43cc-bb22-146b69413c0f_67505c88-110b-4e90-8c8c-9b32f4fa3797.html,,oral,LD50,"5,000 mg/kg bw",, "Soybean oil, epoxidized",8013-07-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c6b4ed6-c363-417d-bcb4-948bf4d0805c/documents/IUC5-171a4707-f931-43cc-bb22-146b69413c0f_67505c88-110b-4e90-8c8c-9b32f4fa3797.html,,dermal,LD50,"2,000 mg/kg bw",, Hexan-6-olide,502-44-3,A 90-day rat inhalation study demonstrates local irritation (as indicated by effects on the eyes and nose) in the absence of any systemic toxicity at an exposure concentration of 45 ppm (203 mg/m3). A local NOAEC of 15 ppm (70 mg/m3) is therefore derived for this study; a systemic NOAEC of 203 mg/m3 is derived. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/471a730a-4f58-4ad5-893a-246ba37f8929/documents/IUC5-88bdae2f-400c-4cc4-ba71-25ed6870cd77_f4928d13-2549-48b0-9a5e-d41b5cbbed9a.html,,,,,, Hexan-6-olide,502-44-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/471a730a-4f58-4ad5-893a-246ba37f8929/documents/IUC5-88bdae2f-400c-4cc4-ba71-25ed6870cd77_f4928d13-2549-48b0-9a5e-d41b5cbbed9a.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,203 mg/m3,,rat Hexan-6-olide,502-44-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/471a730a-4f58-4ad5-893a-246ba37f8929/documents/IUC5-88bdae2f-400c-4cc4-ba71-25ed6870cd77_f4928d13-2549-48b0-9a5e-d41b5cbbed9a.html,Repeated dose toxicity – local effects,inhalation,NOAEC,70 mg/m3,no adverse effect observed,rat Hexan-6-olide,502-44-3, The substance is of low acute toxicity by the oral roure (LD50 values reported are >2000-4290 mg/kg bw) and also by the dermal route (LD50 6400 mg/kg bw). Acute toxicity by inhalation is not investigated due to the low volatilty of the substance; this is not considered to be a relevant expousre route and a waiver is proposed according to Column 2 of Annex VIII of the REACH Regulation. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/471a730a-4f58-4ad5-893a-246ba37f8929/documents/IUC5-f92fe211-1132-4ad8-acc7-7d5456a58d76_f4928d13-2549-48b0-9a5e-d41b5cbbed9a.html,,,,,, Hexan-6-olide,502-44-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/471a730a-4f58-4ad5-893a-246ba37f8929/documents/IUC5-f92fe211-1132-4ad8-acc7-7d5456a58d76_f4928d13-2549-48b0-9a5e-d41b5cbbed9a.html,,oral,LD50,"4,290 mg/kg bw",no adverse effect observed, Hexan-6-olide,502-44-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/471a730a-4f58-4ad5-893a-246ba37f8929/documents/IUC5-f92fe211-1132-4ad8-acc7-7d5456a58d76_f4928d13-2549-48b0-9a5e-d41b5cbbed9a.html,,dermal,LD50,"6,400 mg/kg bw",no adverse effect observed, (Z)-docos-13-enamide,112-84-5,Oral (OECD 408): NOAEL (subchronic) >= 1000 mg/kg bw/day (male/female)Waiving - Repeated dose toxicity: inhalationWaiving - Repeated dose toxicity: dermal ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4bb39c5-c8f2-4bf2-b59f-0694ce7741fa/documents/IUC5-51ceda97-014f-4646-bf46-b9a9b3c944b0_fc560ac0-9d6f-4f85-a0d7-e5dace302d86.html,,,,,, (Z)-docos-13-enamide,112-84-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4bb39c5-c8f2-4bf2-b59f-0694ce7741fa/documents/IUC5-51ceda97-014f-4646-bf46-b9a9b3c944b0_fc560ac0-9d6f-4f85-a0d7-e5dace302d86.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat (Z)-docos-13-enamide,112-84-5,Oral (OECD 423): LD50 > 5000 mg/kg bw Inhalation (OECD 436): LC50 > 2.8 mg/L air Dermal (OECD 402): LD50 > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4bb39c5-c8f2-4bf2-b59f-0694ce7741fa/documents/IUC5-d30e9aec-5d92-42b9-80e3-476e83c7ef73_fc560ac0-9d6f-4f85-a0d7-e5dace302d86.html,,,,,, (Z)-docos-13-enamide,112-84-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4bb39c5-c8f2-4bf2-b59f-0694ce7741fa/documents/IUC5-d30e9aec-5d92-42b9-80e3-476e83c7ef73_fc560ac0-9d6f-4f85-a0d7-e5dace302d86.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, (Z)-docos-13-enamide,112-84-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4bb39c5-c8f2-4bf2-b59f-0694ce7741fa/documents/IUC5-d30e9aec-5d92-42b9-80e3-476e83c7ef73_fc560ac0-9d6f-4f85-a0d7-e5dace302d86.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, (Z)-docos-13-enamide,112-84-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4bb39c5-c8f2-4bf2-b59f-0694ce7741fa/documents/IUC5-d30e9aec-5d92-42b9-80e3-476e83c7ef73_fc560ac0-9d6f-4f85-a0d7-e5dace302d86.html,,inhalation,LC50,2.8 ,no adverse effect observed, Erythritol,149-32-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e18c461-19b2-4933-8462-894df6536db7/documents/7740d3e4-6917-40f5-aefa-d7823411437b_65f88623-506c-4f3c-8e02-79202390367e.html,,oral,LD50,"13,100 mg/kg bw",no adverse effect observed, Aesculin,531-75-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): LD50 >2000 mg/kg bw, LD50 cut-off (rat): 5000 mg/kg OECD guideline study ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ded8f23-2cc8-4b53-addd-5c48f9d5457e/documents/5de4d12d-62e4-4052-b58a-3255b37f5fa8_b2efa0e6-2bbc-48a0-8c37-e5c6d6741d61.html,,,,,, Aesculin,531-75-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ded8f23-2cc8-4b53-addd-5c48f9d5457e/documents/5de4d12d-62e4-4052-b58a-3255b37f5fa8_b2efa0e6-2bbc-48a0-8c37-e5c6d6741d61.html,,oral,LD50,"5,000 mg/kg bw",, Estradiol,50-28-2,"Study report: Test substance was administered to 3 Sprague Dawley rats each group daily via gavage for 5 days. Doses applied were 20 and 300 mg/kg bw/d. Spraque-Dawley rats revealed transient decrease in body weight gain and water consumption at 20 and 300 mg/kg, but no liver toxicity (Research Report No. AG69). Study report: Test substance was administered in combination with Levonorgestrel to 10 female Jcl: Sprague Dawley SDrats/dose in 0.5% CMC-Na + 0.04% Tween 80 by gavage at dose levels of 0 (control), 0.02, 0.4 and 20 mg/kg bw/day for 28 consecutive days. Additionally, Estradiol was administered to 10 female Jcl:SD rats at a dose of 18.2 mg/kg bw for 10 days. Control, Estradiol and high dose groups included 6 additional animals per sex to be sacrificed after 2 weeks of recovery. No mortality occurred. No clinical signs and no changes were observed at the weekly detailed clinical observations. Some changes on body weight and food consumption were noted. Body weight gains were significantly inhibited in the 20000 µg/kg and E2 groups during the treatment period. Significant decreases in RBC, Hb, PCV and MCHC were observed in the 20000 µg/kg and E2 groups. Reversible effects in coagulation were seen in the highest dose group. On the basis of the results obtained in this study, the dose level of 0.4 mg/kg bw/day was considered the LOEL (Lowest Observed Effect Level).   Other studies revealed no effects during a subacute treatment period. Application of Estradiol (1.28 mg/kg or 2.4 mg/kg every third day or 1.28 mg/kg once a week) to beagle dogs showed clinical, haematological, biochemical and histopathological effects but not indication of neoplastic or anaplastic processes (Research Report No. 3102). Several clinical studies are available, indicating different effects after long-term exposure to Estradiol. Only few real repeated dose studies were found for Estradiol in the literature, most reports focussed on carcinogenic effects. Nevertheless, effects on several organs, hematopoiesis, centrilobular hepatocellular hypertrophy, diffuse hyperplasia of the pituitary gland, feminization of the male mammary gland, mammary gland hyperplasia in females, cystic ovarian follicles, hypertrophy of the endometrium and endometrial glands in the uterus, degeneration of the seminiferous epithelium, and atrophy of the testes and accessory sex glands were reported. The toxic effects of Estradiol are an exaggeration of the normal pharmacological effects and result in an increase of female characteristics. Estradiol is widely used for oral contraception and in post-menopausal hormonal therapy. Therefore a wide base of case reports is available pointing out various types of adverse effects. The most frequent adverse dermatologic reaction associated with estrogen therapy is chloasma, melasma and erythema. An increased risk of thromboembolic and thrombotic disorders including thrombophlebitis, pulmonary embolism, stroke, subarachnoid hemorrhage, and myocardial infarction was reported for the use as oral contraceptive as well as breakthrough bleeding, spotting, changes in menstrual flow, missed menses (during use), or amenorrhea (after use). Dysmenorrhea and a premenstrual-like syndrome also occurred. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): comparable to guideline study Klimisch score 2 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43ad681e-1f64-4f2e-925b-a253860434b5/documents/IUC5-7b379628-7e5c-430d-88d5-78eff24f1455_32ed48fd-a2ac-43e8-82e4-bd55ebdda90e.html,,,,,, Estradiol,50-28-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43ad681e-1f64-4f2e-925b-a253860434b5/documents/IUC5-7b379628-7e5c-430d-88d5-78eff24f1455_32ed48fd-a2ac-43e8-82e4-bd55ebdda90e.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,0.4 mg/kg bw/day,,rat Estradiol,50-28-2,"LD50 oral (rat):> 2000 mg/kg bw [report, Ishida 2001] ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43ad681e-1f64-4f2e-925b-a253860434b5/documents/IUC5-3419281e-b3d9-4f99-b8ce-3886059da309_32ed48fd-a2ac-43e8-82e4-bd55ebdda90e.html,,,,,, Estradiol,50-28-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43ad681e-1f64-4f2e-925b-a253860434b5/documents/IUC5-3419281e-b3d9-4f99-b8ce-3886059da309_32ed48fd-a2ac-43e8-82e4-bd55ebdda90e.html,,oral,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, Ethane,74-84-0," Members of the Petroleum Gases category show low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration for the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04e385b3-c15d-4703-979c-8a612e2d196a/documents/IUC5-ea1b160f-72da-4646-96bd-142ff2ea98fc_d1699273-f196-4503-b9b4-664e4d886d35.html,,,,,, Ethane,74-84-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04e385b3-c15d-4703-979c-8a612e2d196a/documents/IUC5-ea1b160f-72da-4646-96bd-142ff2ea98fc_d1699273-f196-4503-b9b4-664e4d886d35.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"4,437 mg/m3",,rat Ethane,74-84-0," The LC50 in mice of a mixture of isobutane, butane, and propane is 57.42% (approximately 539,600 ppm). The LC50 in rats of propane exceeds 800000 ppm (equivalent to 1,442,738 mg/m3 or 1443 mg/L)). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04e385b3-c15d-4703-979c-8a612e2d196a/documents/IUC5-0e932d4a-93f7-4136-a726-befb579d5a96_d1699273-f196-4503-b9b4-664e4d886d35.html,,,,,, 2-aminoethanol,141-43-5," The exposure of rats to the test substance for 28 days by inhalation caused concentration-related lesions in larynx, trachea and lung. No histopathological effects were seen in any other organ outside the respiratory tract. The NOAEC for systemic toxicity is the highest tested concentration of 150 mg/m3. The NOAEC for local effects was the lowest tested concentration of 10 mg/m3. In the two-generation oral reproductive toxicity study with the test substance (HCl), the NOAEL for general systemic toxicity was set at 300 mg/kg bw/day based on reduced food consumption and/or body weight gain, as well as organ weight changes unaccompanied by histopathological findings. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bbbc7157-d338-419d-b0e9-fe9687bc18d4/documents/IUC5-a22fd65c-2375-491a-b6ab-08ca02c2b84f_8e662a50-3341-44c9-b87c-95c6879731ee.html,,,,,, 2-aminoethanol,141-43-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bbbc7157-d338-419d-b0e9-fe9687bc18d4/documents/IUC5-a22fd65c-2375-491a-b6ab-08ca02c2b84f_8e662a50-3341-44c9-b87c-95c6879731ee.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,150 mg/m3,,rat 2-aminoethanol,141-43-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bbbc7157-d338-419d-b0e9-fe9687bc18d4/documents/IUC5-a22fd65c-2375-491a-b6ab-08ca02c2b84f_8e662a50-3341-44c9-b87c-95c6879731ee.html,Chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 2-aminoethanol,141-43-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bbbc7157-d338-419d-b0e9-fe9687bc18d4/documents/IUC5-a22fd65c-2375-491a-b6ab-08ca02c2b84f_8e662a50-3341-44c9-b87c-95c6879731ee.html,Repeated dose toxicity – local effects,inhalation,NOAEC,10 mg/m3,adverse effect observed,rat 2-aminoethanol,141-43-5," The LD50 values for acute oral toxicity is 1089 mg/kg bw in rats. The LD50 values for acute dermal toxicity is 2504 mg/kg bw in rats. The LC50 value for acute inhalation toxicity for 6 hours exposure duration, was established to exceed 1300 mg/m3, corresponding to a recalculated value for 4 hours of 1487 mg/m3.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbbc7157-d338-419d-b0e9-fe9687bc18d4/documents/IUC5-77f29e3d-5a30-4629-abd9-b66a017b2057_8e662a50-3341-44c9-b87c-95c6879731ee.html,,,,,, 2-aminoethanol,141-43-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbbc7157-d338-419d-b0e9-fe9687bc18d4/documents/IUC5-77f29e3d-5a30-4629-abd9-b66a017b2057_8e662a50-3341-44c9-b87c-95c6879731ee.html,,oral,LD50,"1,089 mg/kg bw",adverse effect observed, 2-aminoethanol,141-43-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbbc7157-d338-419d-b0e9-fe9687bc18d4/documents/IUC5-77f29e3d-5a30-4629-abd9-b66a017b2057_8e662a50-3341-44c9-b87c-95c6879731ee.html,,dermal,LD50,"2,504 mg/kg bw",adverse effect observed, 2-aminoethanol,141-43-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbbc7157-d338-419d-b0e9-fe9687bc18d4/documents/IUC5-77f29e3d-5a30-4629-abd9-b66a017b2057_8e662a50-3341-44c9-b87c-95c6879731ee.html,,inhalation,discriminating conc.,"1,487 mg/m3",no adverse effect observed, (2-hydroxyethyl)ammonium mercaptoacetate,126-97-6,"No reliable data is available on the repeated dose toxicity of MeaTG. However, the subchronic toxicity of sodium thioglycolate was evaluated by oral and dermal administrations. In an oral repeated dose toxicity study (OECD 408), sodium mercaptoacetate was administered by gavage, 7 days/week, for 13 weeks, to male and female Sprague-Dawley rats. Sporadic mortality and fully reversible effects on some haematological and biochemical parameters and histopathological changes in liver were observed at 60 mg/kg bw/d. These effects may be related to the inhibition of the β-oxidation of fatty acids a known mechanism of action of sodium mercaptoacetate. Consequently, based on the effects observed at 60 mg a. i. /kg/day, particularly mortality, hematological and significant blood chemistry changes associated with liver microscopic changes and the limited blood chemistry effects without microscopic adverse changes in the liver observed at 20 mg a. i. /kg/day, the NOAEL of sodium mercaptoacetate was 20 mg a. i. /kg/day, and the NOEL was 7 mg a. i. /kg/day given by daily oral administration (gavage) to rats for 13 weeks. Additional information on the oral repeated dose toxicity of sodium mercaptoacetate is provided by the 2-generation reprotoxicity study (OECD 416) study and the reproduction/developmental screening test (OECD 421). The results of both studies support the NOAEL 20 mg a. i. /kg/day defined in the 13-week toxicity study. In a repeated dose dermal toxicity (OECD 411), sodium mercaptoacetate was administered via dermal route, 5 days per week, for 13 weeks to male and female Fischer 344 rats and B6C3F1 mice. All animals survived the 13 weeks administration. The only treatment related effect was skin irritation at the site of application. The LOELs for skin irritation were 11.25 and 45 mg/kg bw/d and the NOAELs for systemic toxicity were higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): adequate and valid ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47514026-f18f-4898-98fb-df5a20e78e06/documents/1ddd96c6-4a97-44a9-9e50-3a0e204f76fa_8f6b46d7-7661-4e06-b4c2-8e128cba944b.html,,,,,, (2-hydroxyethyl)ammonium mercaptoacetate,126-97-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47514026-f18f-4898-98fb-df5a20e78e06/documents/1ddd96c6-4a97-44a9-9e50-3a0e204f76fa_8f6b46d7-7661-4e06-b4c2-8e128cba944b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,27 mg/kg bw/day,,rat (2-hydroxyethyl)ammonium mercaptoacetate,126-97-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47514026-f18f-4898-98fb-df5a20e78e06/documents/1ddd96c6-4a97-44a9-9e50-3a0e204f76fa_8f6b46d7-7661-4e06-b4c2-8e128cba944b.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,242 mg/kg bw/day,,rat (2-hydroxyethyl)ammonium mercaptoacetate,126-97-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47514026-f18f-4898-98fb-df5a20e78e06/documents/1ddd96c6-4a97-44a9-9e50-3a0e204f76fa_8f6b46d7-7661-4e06-b4c2-8e128cba944b.html,Repeated dose toxicity – local effects,dermal,LOAEL,63 ,adverse effect observed, (2-hydroxyethyl)ammonium mercaptoacetate,126-97-6,MeaTG is toxic (Acute Tox 3) by ingestion. In contact with skin MEATG can cause irritating effects locally. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47514026-f18f-4898-98fb-df5a20e78e06/documents/IUC5-5d22c001-229c-46c5-a720-3467fa921044_8f6b46d7-7661-4e06-b4c2-8e128cba944b.html,,,,,, (2-hydroxyethyl)ammonium mercaptoacetate,126-97-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47514026-f18f-4898-98fb-df5a20e78e06/documents/IUC5-5d22c001-229c-46c5-a720-3467fa921044_8f6b46d7-7661-4e06-b4c2-8e128cba944b.html,,oral,LD50,181 mg/kg bw,adverse effect observed, (2-hydroxyethyl)ammonium mercaptoacetate,126-97-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47514026-f18f-4898-98fb-df5a20e78e06/documents/IUC5-5d22c001-229c-46c5-a720-3467fa921044_8f6b46d7-7661-4e06-b4c2-8e128cba944b.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-(2-ethoxyethoxy)ethanol,111-90-0," RELIABLE DATA, ORAL ROUTE, NOAEL values: Dog: 1000 mg/kg (90 day) Rat: 250, 800 (90 day), 1340mg/kg (42 day) Mouse: ~5000mg/kg (14 day), 1000mg/kg (28 day) Pig: 167mg/kg (90 day) INHALATION NOEC (28 days, rats) >saturated vapour pressure. Local effects with NOEC of 0.09mg/L DERMAL (mg/kgbw/day) Rabbit 28 day: Systemic effects NOAEL>1000. Local effects NOAEL=300 (based on histopathology), NOEL=100 based on transient irritation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6551807-ac8e-441b-a13b-b559326f09c0/documents/IUC5-8eecfa03-fa3a-450b-b004-4fe4c3205cd7_f0d4aef3-bc04-47cc-b7a9-e9b80792a89d.html,,,,,, 2-(2-ethoxyethoxy)ethanol,111-90-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6551807-ac8e-441b-a13b-b559326f09c0/documents/IUC5-8eecfa03-fa3a-450b-b004-4fe4c3205cd7_f0d4aef3-bc04-47cc-b7a9-e9b80792a89d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, 2-(2-ethoxyethoxy)ethanol,111-90-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6551807-ac8e-441b-a13b-b559326f09c0/documents/IUC5-8eecfa03-fa3a-450b-b004-4fe4c3205cd7_f0d4aef3-bc04-47cc-b7a9-e9b80792a89d.html,Repeated dose toxicity – local effects,inhalation,NOAEC,90 mg/m3,adverse effect observed,rat 2-(2-ethoxyethoxy)ethanol,111-90-0,"ORAL LD50 values:Rat, male: 5900-6100, 6310, 6439, 7300, 9740, 10502 (fasted), 15918 (fed) mg/kg, >5000mg/kg. 6.62mg/kgRat, female :4900-5600mg/kg, <5000mg/kg, 6.42mg/kgRat, sex not specified: 3956-4945, >5000, 5340, 5400, 5500, 6300, 6400, 6500, 7500, 8690mg/kgMouse, male: 6031mg/kg (fed and fasted)Mouse, sex not specified: 6500, 7248, 7863, 12400mg/kgRabbit: 4450, 5600mg/kgGuinea pig: 3000, 3800, 4970 mg/kgINHALATIONLC50>saturated vapour pressure (0.94mg/l)LC50>5.24mg/l (aerosol)DERMAL (mg/kgbw)Rabbit: male: 9143, 1176. Female: 8476. Sex not specified: 7714, 8500Guinea pig: 5900 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6551807-ac8e-441b-a13b-b559326f09c0/documents/IUC5-69f61536-1fb1-4c2e-a5b9-c82817a2f0f6_f0d4aef3-bc04-47cc-b7a9-e9b80792a89d.html,,,,,, 2-(2-ethoxyethoxy)ethanol,111-90-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6551807-ac8e-441b-a13b-b559326f09c0/documents/IUC5-69f61536-1fb1-4c2e-a5b9-c82817a2f0f6_f0d4aef3-bc04-47cc-b7a9-e9b80792a89d.html,,oral,LD50,"6,031 mg/kg bw",, 2-(2-ethoxyethoxy)ethanol,111-90-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6551807-ac8e-441b-a13b-b559326f09c0/documents/IUC5-69f61536-1fb1-4c2e-a5b9-c82817a2f0f6_f0d4aef3-bc04-47cc-b7a9-e9b80792a89d.html,,dermal,LD50,"9,143 mg/kg bw",, 2-(2-ethoxyethoxy)ethyl acetate,112-15-2,"Inhalation: NOAEC (rat, m/f) = 520 mg/m³ (subchronic) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5b5361b-3179-4eb5-94fb-351e53c3cfc4/documents/IUC5-618e5ffb-b9e7-4479-b8f3-6885d2c05b12_e3608d52-1197-4fe4-ad39-dfd5b4c62dcb.html,,,,,, 2-(2-ethoxyethoxy)ethyl acetate,112-15-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5b5361b-3179-4eb5-94fb-351e53c3cfc4/documents/IUC5-618e5ffb-b9e7-4479-b8f3-6885d2c05b12_e3608d52-1197-4fe4-ad39-dfd5b4c62dcb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-(2-ethoxyethoxy)ethyl acetate,112-15-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5b5361b-3179-4eb5-94fb-351e53c3cfc4/documents/IUC5-618e5ffb-b9e7-4479-b8f3-6885d2c05b12_e3608d52-1197-4fe4-ad39-dfd5b4c62dcb.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,520 mg/m3,,rat 2-(2-ethoxyethoxy)ethyl acetate,112-15-2,Oral: LD50 = 3930 mg/kg bwInhalation: LC0 = ca. 1 mg/LDermal: LD50 = > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5b5361b-3179-4eb5-94fb-351e53c3cfc4/documents/IUC5-bd48826b-337b-40c9-b208-c6a9827c5302_e3608d52-1197-4fe4-ad39-dfd5b4c62dcb.html,,,,,, 2-(2-ethoxyethoxy)ethyl acrylate,7328-17-8," OECD 422 study:.   Three groups of ten male and ten female rats received Ethoxy ethoxy ethyl acrylate at doses of 25, 75 and 225 mg/kg/day by oral gavage administration. Males were treated daily for two weeks before pairing, up to necropsy after a minimum of five consecutive weeks. Females were treated daily for two weeks before pairing, throughout pairing, gestation and until Day 13 of lactation   Oral administration of Ethoxy ethoxy ethyl acrylatewas well toleratedwith no mortalities and no adverse effects of treatment on clinical condition, sensory reactivity, grip strength, motor activity, body weight gain, food intake or blood chemistry measurements in males and females treated with Ethoxy ethoxy ethyl acrylate.   Microscopic findings in the stomach of males and females treated at 75 or225 mg/kg/day are compatible with secondary (reactive) changes due to an irritant effect of the test item on the stomach when administered by oral gavage. Inflammatory lesions were present in the glandular and non-glandular region of the stomach.   Macroscopically enlarged local lymph nodes in males treated at 225 mg/kg/day show histological features suggestive of local immunostimulation, which could be secondary to the gastric inflammatory changes.   In addition, an increase in total and differential leucocyte counts were observed in males treated at 225 mg/kg/day which is likely secondary due to the minimal to moderate inflammatory changes observed at microscopic evaluation in the forestomach of 9/10 males in this group. However, no similar increase in leucocyte counts was detected in females treated at 225 mg/kg/day despite the minimal to slight microscopic stomach lesions observed in 9/10 females at this dose level.   A NOAELanda LOAEL were establishedto 25- and 75 mg/kgbw/day, respectively both for effects related to local stomach inflammation observed in both sexes. Furthermore a NOAEL for systemic toxicity at 225 mg/kg kg/day can be concluded. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/658d91f4-1a72-4456-b81c-1d66dce8f17a/documents/IUC5-b8932aef-3fad-4d16-afec-f8b1091f56c2_56c485e9-5bc6-4af1-9946-59e8c9a4dd92.html,,,,,, 2-(2-ethoxyethoxy)ethyl acrylate,7328-17-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/658d91f4-1a72-4456-b81c-1d66dce8f17a/documents/IUC5-b8932aef-3fad-4d16-afec-f8b1091f56c2_56c485e9-5bc6-4af1-9946-59e8c9a4dd92.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,225 mg/kg bw/day,,rat 2-(2-ethoxyethoxy)ethyl acrylate,7328-17-8, Acute oral toxicity: Ethoxyethoxyethyl acrylate (EOEOEA) was reported to have an oral LD50 = 1850 mg/kg bw in rats whereas the Danish QSAR database predicted an oral LD50 = 900mg/kg bw in rats for the substance. Based on this information EOEOEA is expected to have an oral LD50 in the range between 900 -1850 mg/kg bw and therefore meets the criteria for Acute Tox. 4 classification (300< x ≤2000 mg/kg bw) according to the CLP regulation 1272/2008.   Acute dermal toxicity: The dermal LD50 values of EOEOEA in male and female Wistar rats was established according to OECD Guideline 402 (Acute Dermal Toxicity) and observed to be within the range of 400-2000 mg/kg bw. In another OECD 402 study male rabbits had a LD50 –value in the range of 1000-2000 mg/kg bw and for females LD50 >2000 mg/kg bw. According to the CLP regulation 1272/2008 the dermal LD50 value obtained in rats meets the criteria for the classification as Acute Tox 3; H311 (200< x ≤1000 mg/kg bw). No data available on inhalational toxicity of EOEOEA. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/658d91f4-1a72-4456-b81c-1d66dce8f17a/documents/IUC5-31d8278e-233a-46fd-9465-0dc6175289ad_56c485e9-5bc6-4af1-9946-59e8c9a4dd92.html,,,,,, 2-(2-ethoxyethoxy)ethyl acrylate,7328-17-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/658d91f4-1a72-4456-b81c-1d66dce8f17a/documents/IUC5-31d8278e-233a-46fd-9465-0dc6175289ad_56c485e9-5bc6-4af1-9946-59e8c9a4dd92.html,,oral,LD50,900 mg/kg bw,adverse effect observed, 2-(2-ethoxyethoxy)ethyl acrylate,7328-17-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/658d91f4-1a72-4456-b81c-1d66dce8f17a/documents/IUC5-31d8278e-233a-46fd-9465-0dc6175289ad_56c485e9-5bc6-4af1-9946-59e8c9a4dd92.html,,dermal,LD50,400 mg/kg bw,adverse effect observed, 2-ethoxyethanol,110-80-5,"In a subchronic oral study (13 weeks) a NOAEL of 100 µL/kg/day (91.9 mg/kg/day, density 0.919 at 25 °C) was determined. Additionally female rats were administered the test substance during gestation (days 1 to 21) and the hereby obtained NOAEL was 25 µL/kg/day. This value was therefore considered as the overall NOAEL for oral repeated dose toxicity (key data from Stenger et al. 1971);In a subchronic study the toxic potential of the test substance 2-ethoxyethanol has been evaluated via inhalation in rats and rabbits. The animals were treated 6 hours daily for 13 weeks. The derived NOELs were 400 ppm for rats and 100 ppm for rabbits (key data from Barbee et al. 1984).In the lowest dose group (1 mL/day applied dermally) the test substance was teratogenic to offspring. Regarding the mean body weight at day 21 of gestation of the lowest dose group (304 g), the applied dose was 3023 mg/kg/day (key data from Hardin 1982). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/692f5e27-e55c-49a8-a30c-00cf8eeacd32/documents/IUC5-5fd11a1d-947b-40f4-ac59-c738e528b509_f7432745-5255-4f06-8662-eb7fd09f4010.html,,,,,, 2-ethoxyethanol,110-80-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/692f5e27-e55c-49a8-a30c-00cf8eeacd32/documents/IUC5-5fd11a1d-947b-40f4-ac59-c738e528b509_f7432745-5255-4f06-8662-eb7fd09f4010.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,23 mg/kg bw/day,,rat 2-ethoxyethanol,110-80-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/692f5e27-e55c-49a8-a30c-00cf8eeacd32/documents/IUC5-5fd11a1d-947b-40f4-ac59-c738e528b509_f7432745-5255-4f06-8662-eb7fd09f4010.html,Short-term repeated dose toxicity – systemic effects,dermal,LOAEL,"3,023 mg/kg bw/day",,rat 2-ethoxyethanol,110-80-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/692f5e27-e55c-49a8-a30c-00cf8eeacd32/documents/IUC5-5fd11a1d-947b-40f4-ac59-c738e528b509_f7432745-5255-4f06-8662-eb7fd09f4010.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,374 mg/m3,,rabbit 2-ethoxyethanol,110-80-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/692f5e27-e55c-49a8-a30c-00cf8eeacd32/documents/IUC5-3cff0a91-e053-4a68-9b81-877ccf5a1110_f7432745-5255-4f06-8662-eb7fd09f4010.html,,oral,LD50,"1,400 mg/kg bw",, 2-ethoxyethanol,110-80-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/692f5e27-e55c-49a8-a30c-00cf8eeacd32/documents/IUC5-3cff0a91-e053-4a68-9b81-877ccf5a1110_f7432745-5255-4f06-8662-eb7fd09f4010.html,,dermal,LD50,"3,271 mg/kg bw",, 2-ethoxyethanol,110-80-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/692f5e27-e55c-49a8-a30c-00cf8eeacd32/documents/IUC5-3cff0a91-e053-4a68-9b81-877ccf5a1110_f7432745-5255-4f06-8662-eb7fd09f4010.html,,inhalation,LC50,"7,360 mg/m3",, "Ethyl 2,6,6-trimethylcyclohexa-1,3-ene-1-carboxylate",35044-59-8,"Oral: LD50= LD50 cut-off > 5000mg/kg bw, female rat, OECD 423, Wil Research B.V. 2015 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/198bee41-bdd5-482a-ac29-18268fe8be95/documents/IUC5-37e4c7d1-284b-4056-ad38-e723bee9740f_b950f8a5-14e7-4bd4-9a23-3090db004cf9.html,,,,,, "Ethyl 2,6,6-trimethylcyclohexa-1,3-ene-1-carboxylate",35044-59-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/198bee41-bdd5-482a-ac29-18268fe8be95/documents/IUC5-37e4c7d1-284b-4056-ad38-e723bee9740f_b950f8a5-14e7-4bd4-9a23-3090db004cf9.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Ethyl 2-methylbutyrate,7452-79-1, No adverse effect found therefore substance not classified. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5a122b0-0ce7-4a44-bb41-32cdf6e9add8/documents/IUC5-696384fd-f40d-4127-b106-35a759d35d11_7b084e52-ff10-4a78-b177-f80f809f75c8.html,,,,,, Ethyl 2-methylbutyrate,7452-79-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5a122b0-0ce7-4a44-bb41-32cdf6e9add8/documents/IUC5-696384fd-f40d-4127-b106-35a759d35d11_7b084e52-ff10-4a78-b177-f80f809f75c8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Ethyl 2-methylbutyrate,7452-79-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Klimisch 1, key study for closely related structural analogue Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch 1 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5a122b0-0ce7-4a44-bb41-32cdf6e9add8/documents/IUC5-aaffcc64-2ead-483d-957d-a6f9946e7661_7b084e52-ff10-4a78-b177-f80f809f75c8.html,,,,,, Ethyl 2-methylbutyrate,7452-79-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5a122b0-0ce7-4a44-bb41-32cdf6e9add8/documents/IUC5-aaffcc64-2ead-483d-957d-a6f9946e7661_7b084e52-ff10-4a78-b177-f80f809f75c8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl 2-methylbutyrate,7452-79-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5a122b0-0ce7-4a44-bb41-32cdf6e9add8/documents/IUC5-aaffcc64-2ead-483d-957d-a6f9946e7661_7b084e52-ff10-4a78-b177-f80f809f75c8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl 2-methylbutyrate,7452-79-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5a122b0-0ce7-4a44-bb41-32cdf6e9add8/documents/IUC5-aaffcc64-2ead-483d-957d-a6f9946e7661_7b084e52-ff10-4a78-b177-f80f809f75c8.html,,inhalation,LC50,"5,967 mg/m3",no adverse effect observed, Ethyl 2-methylvalerate,39255-32-8, EMB did not induce any significant signs of systemic toxicityand no evidence of reproductive or developmental toxicity in rats dosed at up to 1000 mg/kg bw/day for up to 51 days. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c63b7a2a-ad7b-4d2f-b846-635dcdd338cc/documents/IUC5-37819c48-513a-46b0-8862-db8537e94908_768a9d18-a0ef-46a1-a5f9-84b3d4e05e47.html,,,,,, Ethyl 2-methylvalerate,39255-32-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c63b7a2a-ad7b-4d2f-b846-635dcdd338cc/documents/IUC5-37819c48-513a-46b0-8862-db8537e94908_768a9d18-a0ef-46a1-a5f9-84b3d4e05e47.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Ethyl 2-methylvalerate,39255-32-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch 2 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c63b7a2a-ad7b-4d2f-b846-635dcdd338cc/documents/IUC5-8c7a105f-c026-44ef-85db-2bf5ad1b348a_768a9d18-a0ef-46a1-a5f9-84b3d4e05e47.html,,,,,, Ethyl 2-methylvalerate,39255-32-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c63b7a2a-ad7b-4d2f-b846-635dcdd338cc/documents/IUC5-8c7a105f-c026-44ef-85db-2bf5ad1b348a_768a9d18-a0ef-46a1-a5f9-84b3d4e05e47.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Ethyl 2-methylvalerate,39255-32-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c63b7a2a-ad7b-4d2f-b846-635dcdd338cc/documents/IUC5-8c7a105f-c026-44ef-85db-2bf5ad1b348a_768a9d18-a0ef-46a1-a5f9-84b3d4e05e47.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Ethyl 2-methylvalerate,39255-32-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c63b7a2a-ad7b-4d2f-b846-635dcdd338cc/documents/IUC5-8c7a105f-c026-44ef-85db-2bf5ad1b348a_768a9d18-a0ef-46a1-a5f9-84b3d4e05e47.html,,inhalation,discriminating conc.,"5,967 mg/m3",no adverse effect observed, Ethyl 3-phenyloxirane-2-carboxylate,121-39-1, Acute oral toxicity (similar to OECD TG 401): 2300 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86814d3e-0263-49d1-b27b-062983b0c5ef/documents/4c5e8b2e-5f19-4737-8c44-8b79aa8ab248_cb6e170c-cfd6-40a2-870f-589cd0fe0cf6.html,,,,,, Ethyl acetate,141-78-6," Based on a high quality, guideline study in rats, the subchronic inhalation NOAEC for systemic toxicity of ethyl acetate is considered to be 350 ppm (1.28 mg/L), based on sedation during exposure, reduced food consumption and reduced body weight gain.  Nasal irritation was observed in this study at all exposure concentrations, therefore, the LOAEC for respiratory irritant effects in rats is considered to be 350 ppm (1.28 mg/L). A subchronic oral NOAEL of 900 mg/kg bw/day was reported in a 90-day oral study in rats cited in the EPA IRIS database (US EPA, 1988), based on depressed food consumption, suppressed body weight gain and clinical signs observed at 3,600 mg/kg/day. Repeated dose dermal studies of ethyl acetate have not been reported. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a46b38b2-09c7-48ce-9ee3-a69bf5cd6e4a/documents/IUC5-84c94d58-f1c2-4053-b5d9-a1077a375fc0_c6135253-4309-4e85-8fe0-bc2875a2dd2d.html,,,,,, Ethyl acetate,141-78-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a46b38b2-09c7-48ce-9ee3-a69bf5cd6e4a/documents/IUC5-84c94d58-f1c2-4053-b5d9-a1077a375fc0_c6135253-4309-4e85-8fe0-bc2875a2dd2d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,900 mg/kg bw/day,, Ethyl acetate,141-78-6," Ethyl acetate has a low order of toxicity in animals following single oral, dermal, or inhalation exposure.   ACUTE ORAL toxicity LD50 values (mg/kg): rat: 5620, 6100, 10200. rabbit: 4934, 7650.  mouse: 4100 ACUTE INHALATION toxicity values (mg/l) rat: LC50: >22.5 (6hr), 200 (1hr), >18 (3-4hr) mouse: LD100 ~8.8, 44 ACUTE DERMAL rabbit: >20g/kg ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a46b38b2-09c7-48ce-9ee3-a69bf5cd6e4a/documents/IUC5-8a0dcfca-5b40-40a6-b8a9-611e298ac9ea_c6135253-4309-4e85-8fe0-bc2875a2dd2d.html,,,,,, Ethyl acetate,141-78-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a46b38b2-09c7-48ce-9ee3-a69bf5cd6e4a/documents/IUC5-8a0dcfca-5b40-40a6-b8a9-611e298ac9ea_c6135253-4309-4e85-8fe0-bc2875a2dd2d.html,,oral,LD50,"4,934 mg/kg bw",, Ethyl acetoacetate,141-97-9," The test item EAA was tested in two subacute oral toxicity studies over 28 days. Treatment was either by gavage or feeding. Both studies were performed under GLP having a Klimisch 1 rating. Dose levels were 0, 50, 225 and 1000 mg/kg/day in the gavage study and 0, 100, 300 and 1000 mg/kg/day in the feeding test. In the gavage test, 5 animals per sex and dose group were treated with the test article. In addition, another 5 animals per sex of the control and highest dose group were treated and further observed in a 2-weeks recovery period. For the feeding study, 16 males and 16 females were tested per dose group, without treatment-free recovery period. There were no toxicologically relevant findings observed in both studies. Results were comparable, in both studies the NOEL/NOAEL values were found to be 1000 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/782a98a4-1835-4529-91ca-419319594b0f/documents/IUC5-a8bb3375-b37e-4f4c-a6c8-dfb76e01b2b7_497467fb-2539-488d-ab07-cc4fca7b26f6.html,,,,,, Ethyl acetoacetate,141-97-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/782a98a4-1835-4529-91ca-419319594b0f/documents/IUC5-a8bb3375-b37e-4f4c-a6c8-dfb76e01b2b7_497467fb-2539-488d-ab07-cc4fca7b26f6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Ethyl acetoacetate,141-97-9," The test item EAA was tested in acute studies by oral and dermal application on rats. The acute oral study was performed before implementation of the corresponding OECD- and GLP-guidelines in 1975, however it provides sufficient information to assess it as key study having Klimisch 2. Acute inhalation toxicity was assessed based on a read-across to the supporting substances Methylacetate and Ethylacetate. An additional Klimisch 3, non-guideline conform study with inhalative, intraperitoneal and oral application is available, but was not further assessed due to its poor quality and limited information). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/782a98a4-1835-4529-91ca-419319594b0f/documents/IUC5-f241aa38-f074-4049-9a2b-3d01c999992c_497467fb-2539-488d-ab07-cc4fca7b26f6.html,,,,,, Ethyl acetoacetate,141-97-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/782a98a4-1835-4529-91ca-419319594b0f/documents/IUC5-f241aa38-f074-4049-9a2b-3d01c999992c_497467fb-2539-488d-ab07-cc4fca7b26f6.html,,oral,LD50,"10,800 mg/kg bw",no adverse effect observed, Ethyl acetoacetate,141-97-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/782a98a4-1835-4529-91ca-419319594b0f/documents/IUC5-f241aa38-f074-4049-9a2b-3d01c999992c_497467fb-2539-488d-ab07-cc4fca7b26f6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl acetoacetate,141-97-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/782a98a4-1835-4529-91ca-419319594b0f/documents/IUC5-f241aa38-f074-4049-9a2b-3d01c999992c_497467fb-2539-488d-ab07-cc4fca7b26f6.html,,inhalation,LC50,49.2 mg/m3,no adverse effect observed, Ethyl acrylate,140-88-5,"In a chronic repeated dose study by the inhalation route a NOAEC of 20 mg/m³ was determined in rats for local effects (nasal irritation). The respective NOAEC for systemic effects was 100 mg/m³ based on body weight decrease. After subchronic exposure by vapour inhalation over 3 months the NOAEC for systemic and toxic effects was 0.1 mg/L, while the respective LOAEC was 0.31 mg/L based on retardation of body weight gain and lesions of the nasal mucosa.After subchronic exposure by gavage over a test period of 90 days, a NOAEL of 55 mg/kg bw/day was determined in rats based on grosspathological changes of the stomach. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b84e7c31-52da-4784-83c6-7ff608be5be6/documents/IUC5-69a10ad4-663f-4c34-bbee-f937ddbe6b2b_11ebaf13-6030-4f0e-8cc5-8ed0d32ed541.html,,,,,, Ethyl acrylate,140-88-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b84e7c31-52da-4784-83c6-7ff608be5be6/documents/IUC5-69a10ad4-663f-4c34-bbee-f937ddbe6b2b_11ebaf13-6030-4f0e-8cc5-8ed0d32ed541.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,20 mg/m3,, Ethyl acrylate,140-88-5,"Ethyl acrylate is of moderate toxicity after a single ingestion and of pronounced toxicity after a short-term inhalation. EA is of low toxicity after a short-term skin contact.Oral: LD50 = 1120 mg/kg bw (rat)Dermal: LD50: 3049 mg/kg bw (rat, occluded)Inhalation: LC50 = 9.0 mg/L (rat) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b84e7c31-52da-4784-83c6-7ff608be5be6/documents/IUC5-8cc661f2-5193-4c40-a083-798c8b117459_11ebaf13-6030-4f0e-8cc5-8ed0d32ed541.html,,,,,, Ethyl acrylate,140-88-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b84e7c31-52da-4784-83c6-7ff608be5be6/documents/IUC5-8cc661f2-5193-4c40-a083-798c8b117459_11ebaf13-6030-4f0e-8cc5-8ed0d32ed541.html,,oral,LD50,"1,120 mg/kg bw",, Ethyl acrylate,140-88-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b84e7c31-52da-4784-83c6-7ff608be5be6/documents/IUC5-8cc661f2-5193-4c40-a083-798c8b117459_11ebaf13-6030-4f0e-8cc5-8ed0d32ed541.html,,dermal,LD50,"3,049 mg/kg bw",, Ethyl acrylate,140-88-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b84e7c31-52da-4784-83c6-7ff608be5be6/documents/IUC5-8cc661f2-5193-4c40-a083-798c8b117459_11ebaf13-6030-4f0e-8cc5-8ed0d32ed541.html,,inhalation,LC50,"9,000 mg/m3",, Ethyl benzoate,93-89-0,"In a Combined Repeated Oral (Dietary) Dose Toxicity Study with Reproduction/Developmental Toxicity Screening Test according to OECD guideline 422, the no observed adverse effect level (NOAEL) of the test substance was 1.6% (corresponding to 953.6 mg/kg bw/day for males and 1294.5 mg/kg bw/day for females) in general toxicity, reproductive toxicity and developmental toxicity respectively, under the conditions of this study. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Reliable without restrictions ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c3c3225-b307-4b8d-947d-f7b1e68178cf/documents/IUC5-bf0ad7be-d5bb-44e6-bdad-70aa3059294e_288b69d1-6343-4a7d-80cd-ecdc9f658bce.html,,,,,, Ethyl benzoate,93-89-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c3c3225-b307-4b8d-947d-f7b1e68178cf/documents/IUC5-bf0ad7be-d5bb-44e6-bdad-70aa3059294e_288b69d1-6343-4a7d-80cd-ecdc9f658bce.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,953.6 mg/kg bw/day,,rat Ethyl benzoate,93-89-0,"oral:The LD50 values determined on three studies on rabbits and rats are greater than 2000 mg/kg bw.inhalation:Ethyl benzoate was not toxic as concentrated vapour to rats in an 8 hour inhalation study.dermal:Several studies on different animal species revealed a LD50 of >2000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available studies used in this weight of evidence approach are sufficient for assessment. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The available studies used in this weight of evidence approach are sufficient for assessment. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c3c3225-b307-4b8d-947d-f7b1e68178cf/documents/IUC5-9a124ca8-6bc3-488f-b731-165163e7fa3d_288b69d1-6343-4a7d-80cd-ecdc9f658bce.html,,,,,, Ethyl 2-naphthyl ether,93-18-5,"Repeated dose subchronic toxicity study was performed by Oser (1965) to determine the toxic nature of test chemical. The chemical was dosed to FDRL strain rats at dose levels of 5.1 mg/Kg in males and 5.7 mg/Kg in females for 90 days. Concurrent solvent control was also incorporated in the study. The animals were noted for usual observations (i.e. body weight and food consumption), haematological and blood chemical determinations, gross pathology and histopathology respectively. Administration of test substance for 90 days at a level in excess of at least 100 times the maximum estimated daily dietary intake in man evoked no adverse effect on growth, food consumption, haematology, blood chemistry, liver and kidney weights or on gross and microscopic appearance of major organs at autopsy. Hence, the No Observed Adverse Effect Level (NOAEL) for test substance is considered to be 5.1 mg/Kg in males and 5.7 mg/Kg in females. The present study is single dose study.The study does not conclude conclude higher dose value. Henceforth it is acceptable to take such low NOAEL .   Repeated inhalation   According to column 2 of REACH Annex VIII, the acute toxicity inhalation study need not be conducted because exposure of humans via inhalation route is not likely taking into account the low vapour pressure of the substance2-Ethoxynaphthalene,which is reported as 0.5182 Pa. Also considering the particle size distribution of the substance the majority of the particle size was determined to be in the range of 150-53 micron which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical2-Ethoxynaphthaleneis highly unlikely. Therefore this study is considered for waiver.   Repeated dermal   The acute toxicity value for 2-Ethoxynaphthalene (as provided in section 7.2.3) is >5000 mg/kg body weight.The substance was also found to be not irrtating to skin. Also, given the use of the chemical as dye compound; repeated exposure by the dermal route is unlikely. Thus, it is expected that 2-Ethoxynaphthalene shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no dermal absorption data as well as no data available that suggests that 2-Ethoxynaphthalene shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a62670ac-289e-4a94-8523-8bcf2d3d0e0b/documents/2cb1d21a-61da-408a-858c-a920fcfae2db_540b1915-18c9-45c5-b488-d0e4ec11921c.html,,,,,, Ethyl 2-naphthyl ether,93-18-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a62670ac-289e-4a94-8523-8bcf2d3d0e0b/documents/2cb1d21a-61da-408a-858c-a920fcfae2db_540b1915-18c9-45c5-b488-d0e4ec11921c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5.7 mg/kg bw/day,,rat Ethyl 2-naphthyl ether,93-18-5,"Acute oral toxicity:  An acute oral toxicity dose (LD50) of target chemical Ethyl 2-naphthyl ether (CAS No. 93-18-5) was considered based on experimental study conducted on rats, the LD50 value was considered to be >2000 mg/kg bw in rats. Thus, comparing this value with the criteria of CLP regulation, Ethyl 2-naphthyl ether cannot be classified for acute oral toxicity.   Acute Inhalation toxicity:  According to column 2 of REACH Annex VIII, the acute toxicity inhalation study need not be conducted because exposure of humans via inhalation route is not likely taking into account the low vapour pressure of the substance Ethyl 2-naphthyl ether (CAS no: 93-18-5),which is reported as 0.5182 Pa (0.00389 mm Hg). Also considering the particle size distribution of the substance the majority of the particle size was determined to be in the range of 150-53 micron which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.   Acute Dermal Toxicity: An acute Dermal toxicity dose (LD50) for target chemical Ethyl 2-naphthyl ether (CAS no: 93-18-5) was considered based on different experimental studies conducted on rats and rabbits, the values were considered to be >2000 mg/kg bw in rats and >5000 mg/kg bw in rabbits. The study concluded that the LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, Ethyl 2-naphthyl ether cannot be classified for acute dermal toxicity.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a62670ac-289e-4a94-8523-8bcf2d3d0e0b/documents/da658915-7043-403b-9491-662358b987e3_540b1915-18c9-45c5-b488-d0e4ec11921c.html,,,,,, Ethyl 2-naphthyl ether,93-18-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a62670ac-289e-4a94-8523-8bcf2d3d0e0b/documents/da658915-7043-403b-9491-662358b987e3_540b1915-18c9-45c5-b488-d0e4ec11921c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl 2-naphthyl ether,93-18-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a62670ac-289e-4a94-8523-8bcf2d3d0e0b/documents/da658915-7043-403b-9491-662358b987e3_540b1915-18c9-45c5-b488-d0e4ec11921c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl butyrate,105-54-4," Repeated oral toxicity In a repeated oral toxicity study, 15 male and 15 female rats were administered 14.4 mg/kg bw of the given test chemical in diet for 12 weeks. No adverse effects were noted in the animals at the mentioned dose level. The No Observed Adverse Effect Level (NOAEL) was considered to be 14.4 mg/kg bw when male and female rats were exposed to the given test chemical for 12 weeks. Repeated inhalative toxicity Male and female Sprague-Dawley Crl:CD rats were exposed to Ethyl butyrate 1 hours/day, 5 days/week for 13 weeks.The comparison of rats exposed to similar concentrations of test (contains the target chemical) and reference cigarette smoke indicated no difference at any concentration Based on the data observed, it can be concluded that Ethyl butyrate did not exert toxicity upon repeated exposure by inhalation route.The NOAEL was estimated as 0.06 mg/L when male and female Sprague-Dawley rats were exposed to Ethyl butyrate by inhalation of cigarette smoke for 13 weeks. Repeated dermal study; The acute toxicity value for Ethyl butyrate (CAS no 105-54-4) (as provided in section 7.2.3) is >2000 mg/kg/body weight per day. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that Ethyl butyrate shall not exhibit toxicity by dermal route upon repeated exposure. route. In addition, no experimental data available that suggests that Ethyl butyrate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dde82e66-c7bf-4c7b-9b78-52c41c91a04f/documents/7eef95b8-a9c9-45c2-bc35-d550e9f200c0_3923dc09-7194-4b97-a4cb-47bc51ece96c.html,,,,,, Ethyl butyrate,105-54-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dde82e66-c7bf-4c7b-9b78-52c41c91a04f/documents/7eef95b8-a9c9-45c2-bc35-d550e9f200c0_3923dc09-7194-4b97-a4cb-47bc51ece96c.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.06 mg/m3,,rat Ethyl butyrate,105-54-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dde82e66-c7bf-4c7b-9b78-52c41c91a04f/documents/7eef95b8-a9c9-45c2-bc35-d550e9f200c0_3923dc09-7194-4b97-a4cb-47bc51ece96c.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Ethyl butyrate,105-54-4," Acute oral toxicity:  Acute oral toxicity dose (LD50) of test chemical was considered based on experimental study conducted on rats, the LD50 value was considered to be >2000 mg/kg bw in rats. Thus, comparing this value with the criteria of CLP regulation, the test chemical cannot be classified for acute oral toxicity. Acute Inhalation toxicity: The acute Inhalation toxicity dose (LC50) for test chemical was considered based on the data available for the structurally and functionally similar read across chemicals. The study concluded that the LC50 value is >5 mg/L(>5000 mg/m3), for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute inhalation toxicity. Acute Dermal Toxicity: Acute Dermal toxicity dose (LD50) for test chemical was considered based on different experimental studies conducted on rats and rabbits, the value was considered to be >2000 mg/kg bw in rats and rabbits. Thus, comparing this value with the criteria of CLP regulation, the test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dde82e66-c7bf-4c7b-9b78-52c41c91a04f/documents/e3c85a21-b0b1-47aa-ac2e-46ab553a178f_3923dc09-7194-4b97-a4cb-47bc51ece96c.html,,,,,, Ethyl butyrate,105-54-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dde82e66-c7bf-4c7b-9b78-52c41c91a04f/documents/e3c85a21-b0b1-47aa-ac2e-46ab553a178f_3923dc09-7194-4b97-a4cb-47bc51ece96c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl butyrate,105-54-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dde82e66-c7bf-4c7b-9b78-52c41c91a04f/documents/e3c85a21-b0b1-47aa-ac2e-46ab553a178f_3923dc09-7194-4b97-a4cb-47bc51ece96c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl butyrate,105-54-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dde82e66-c7bf-4c7b-9b78-52c41c91a04f/documents/e3c85a21-b0b1-47aa-ac2e-46ab553a178f_3923dc09-7194-4b97-a4cb-47bc51ece96c.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Ethyl decanoate,110-38-3," Based on the category approach and on the available experimental results, the NOAEL value applied for the category is higher than 800 mg/kg bw. Hence, the category substances and the target substance did not required classification for STOT-RE in absence of adverse effects according to CLP criteria. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6be1b23-c33c-40a4-9e83-0cf57f9c0b83/documents/4b9c4857-c832-4e77-9bf3-8fde6a7a3348_c81b736d-f376-47b7-ba19-1692a24d1ff4.html,,,,,, Ethyl decanoate,110-38-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6be1b23-c33c-40a4-9e83-0cf57f9c0b83/documents/4b9c4857-c832-4e77-9bf3-8fde6a7a3348_c81b736d-f376-47b7-ba19-1692a24d1ff4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,800 mg/kg bw/day,,rat Ethyl decanoate,110-38-3," Using the read-across appraoch, according to the Annex XI item 1.5, of Regulation (EC) No 1907/2006, all available acute oral toxicity studies within the category resulted in an acute oral LD50 values higher than 2000 mg/kg bw for oral administration and dermal application, and LC50 was defined to be higher than 5 mg/L for inhalation. Hence, according to CLP criteria and REACh regualtion, the target substance ethyl decanoate is not classified for acute hazard and STOT-SE. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6be1b23-c33c-40a4-9e83-0cf57f9c0b83/documents/fe01e698-a13e-484e-a974-f1c12e081970_c81b736d-f376-47b7-ba19-1692a24d1ff4.html,,,,,, Ethyl decanoate,110-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6be1b23-c33c-40a4-9e83-0cf57f9c0b83/documents/fe01e698-a13e-484e-a974-f1c12e081970_c81b736d-f376-47b7-ba19-1692a24d1ff4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl decanoate,110-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6be1b23-c33c-40a4-9e83-0cf57f9c0b83/documents/fe01e698-a13e-484e-a974-f1c12e081970_c81b736d-f376-47b7-ba19-1692a24d1ff4.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, Ethyl decanoate,110-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6be1b23-c33c-40a4-9e83-0cf57f9c0b83/documents/fe01e698-a13e-484e-a974-f1c12e081970_c81b736d-f376-47b7-ba19-1692a24d1ff4.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Ethyl cinnamate,103-36-6," Based on read across to an appropriate source substance, the substance is not considered to be toxic after oral repeated dosing. Rat: Oral (OECD 422): NOAEL = 443.7 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbf5dfd0-3e2b-4732-8e1c-3cb991128147/documents/fd004b80-4595-445c-9275-be343fd257d1_a1628c06-6075-4dc8-b83c-99d8b78fa4fe.html,,,,,, Ethyl cinnamate,103-36-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbf5dfd0-3e2b-4732-8e1c-3cb991128147/documents/fd004b80-4595-445c-9275-be343fd257d1_a1628c06-6075-4dc8-b83c-99d8b78fa4fe.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,443.7 mg/kg bw/day,,rat Ethyl cinnamate,103-36-6,The test item is not an acute toxic substance via the oral route. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbf5dfd0-3e2b-4732-8e1c-3cb991128147/documents/0cc18ca2-f20b-4b2e-8c81-e89a540122dc_a1628c06-6075-4dc8-b83c-99d8b78fa4fe.html,,,,,, Ethyl cinnamate,103-36-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbf5dfd0-3e2b-4732-8e1c-3cb991128147/documents/0cc18ca2-f20b-4b2e-8c81-e89a540122dc_a1628c06-6075-4dc8-b83c-99d8b78fa4fe.html,,oral,LD50,"2,426 mg/kg bw",adverse effect observed, Ethyl cinnamate,103-36-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbf5dfd0-3e2b-4732-8e1c-3cb991128147/documents/0cc18ca2-f20b-4b2e-8c81-e89a540122dc_a1628c06-6075-4dc8-b83c-99d8b78fa4fe.html,,dermal,LD50,"2,217 mg/kg bw",adverse effect observed, Ethyl 2-cyanoacrylate,7085-85-0," Alkyl 2-cyanoacrylates such as ethyl 2-cyanoacrylate (ECA) are known to polymerize rapidly in the presence of water. According to Annex XI of the REACH Regulation, a test can be waived for technical reasons if the test substance is e.g. highly active. Study data shows that the polymerisation of ECA takes at maximum a few minutes to be completed, depending on the specific conditions of reaction (see 7.1.1. Basic toxikokinetics, study on polymerisation speed). This is supported by the statement by Krall et al. (1983) that alkyl 2-cyanoacrylates ""polymerize on and adhere to moist living tissues"". This effect is the basis for using this substance class as tissue adhesives in medical applications. Both, the study by Ousterhout et al. included in IUCLID section 7.1.1. and the acute oral study included in section 7.2.1 show, that oral application of fast reacting cyanoacrylates, including ECA, results in the immediate generation of a polymeric material on the mucosa or in the cavities of the gastro-intestinal tract. Effects exerted by this material and its potential degradation products do not represent the intrinsic properties of the monomeric ethyl 2-cyanoacrylate, for which systemic availability at relevant doses can be excluded. Similar effects would be expected by exposure via the inhalation route, where ECA quickly polymerizes in the humidity of the respiratory tract. For the same reason, a dermal repeated dose study is technically not feasible. Via all routes, exposure will finally occur to the polymer and not to monomeric ECA. The intrinsic property to polymerize in the presence of water limits the absorption of cyanoacrylates via all three routes (oral, dermal, inhalation). Since the intrinsic hazard of ECA cannot be evaluated in repeated dose studies, the studies are waived according to REACH Annex XI, section 2. This is in accordance with the ECHA guidance (chapter R.5, version 2.1 of December 2011), in which in chapter R.5.2.2 the example of a substance having a high reactivity with water is explicitly mentioned as a case where testing might not be feasible for technical reasons. References: Krall R. E., Neuwirth R. S. and Richart R. M., Pharmacology and Toxicology of Methyl Cyanoacrylate, Fem. Transcervic Steril., Proc. Int. Workshop, 1983, pp175 -185 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ddab6eb-2df2-4997-95f7-f885fbeced5f/documents/28e98b2e-bf18-4447-8601-c84d5da9959a_a10eedf9-a89d-422d-b46a-c9041ff8033a.html,,,,,, Ethyl 2-cyanoacrylate,7085-85-0, All available data on ethyl 2-cyanoacrylate (ECA) indicate an absence of lethal effects after application of doses >2000 mg/kg body weight via the oral or dermal route. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ddab6eb-2df2-4997-95f7-f885fbeced5f/documents/2851213a-dfb0-446d-8d25-03ea5c0b2430_a10eedf9-a89d-422d-b46a-c9041ff8033a.html,,,,,, Ethyl 4-dimethylaminobenzoate,10287-53-3,"A 28-day repeated toxicity study performed by oral route in rats is available on Ethyl 4-dimethylaminobenzoate. Under the conditions of this study the NOAEL was determined to be 74 mg/kg/day based on the testicular atrophy and anemia observed at 900 mg/kg/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available study was performed in accordance with standardised guidelines under GLP conditions. The quality of the database is considered to be high. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/414cdb6c-16e6-4cf1-8be4-a7dc36743306/documents/742c1500-8191-495f-a18d-973be3fa304f_dd5d39fc-c46a-4c6a-8933-49f6cceb8f67.html,,,,,, Ethyl 4-dimethylaminobenzoate,10287-53-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/414cdb6c-16e6-4cf1-8be4-a7dc36743306/documents/742c1500-8191-495f-a18d-973be3fa304f_dd5d39fc-c46a-4c6a-8933-49f6cceb8f67.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,74 mg/kg bw/day,,rat Ethyl 4-dimethylaminobenzoate,10287-53-3,"Based on the available data, Ethyl 4-dimethylaminobenzoate induced no mortality in rats after one administration of 2000 mg/kg/day by oral or dermal route. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): One study is available to address this endpoint. The study was performed in accordance with standardised guidelines. The quality of the database is therefore considered to be good. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): One study is available to address this endpoint. The study was performed in accordance with standardised guidelines. The quality of the database is therefore considered to be good. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/414cdb6c-16e6-4cf1-8be4-a7dc36743306/documents/ea1e7994-55b7-4749-8874-dc574176e9f0_dd5d39fc-c46a-4c6a-8933-49f6cceb8f67.html,,,,,, Ethyl 4-dimethylaminobenzoate,10287-53-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/414cdb6c-16e6-4cf1-8be4-a7dc36743306/documents/ea1e7994-55b7-4749-8874-dc574176e9f0_dd5d39fc-c46a-4c6a-8933-49f6cceb8f67.html,,oral,LD0,"2,000 mg/kg bw",no adverse effect observed, Ethyl 4-dimethylaminobenzoate,10287-53-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/414cdb6c-16e6-4cf1-8be4-a7dc36743306/documents/ea1e7994-55b7-4749-8874-dc574176e9f0_dd5d39fc-c46a-4c6a-8933-49f6cceb8f67.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, "Ethyl 2,4-dimethyl-1,3-dioxolane-2-acetate",6290-17-1, Acute oral toxicity (OECD423): LD50 > 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12ddffad-88e2-40e1-960e-b6ef0bb6ae6b/documents/61fe05f5-6b04-45bd-8c5e-18e4b1ff959f_46cdf935-acad-4467-b153-ba8f18c85e84.html,,,,,, 2-ethylaminoethanol,110-73-6,"   Read-across to DEA: - Nose-only exposure of rats to DEA aerosols for 3 months (OECD TG 413) resulted in a systemic NOAEC of 15 mg/m³ and the NOAEC for local respiratory tract effects was 3 mg/m³. - Repeated unoccluded dermal application of ethanolic DEA solutions in subchronic (13 weeks, protocol similar to OECD TG 411) a NOAEL for systemic effects or local skin irritation could not be achieved (LOAEL 32 mg/kg bw in rats; 80 mg/kg bw in mice). The 2 year dermal studies (NTP, 1999, protocol similar to OECD TG 451) with rats and mice also showed non-carcinogenic effects. Critical effects appear to be kidney (nephropathy) and liver toxicity, anaemia and dermal hyperkeratosis/acanthosis. The overall dermal LOAEL based on the 13 week and 2 years study is concluded to be 8 mg/kg bw/day. - In rats, subchronic oral treatment via the drinking water (protocol similar to OECD TG 408) resulted in a LOAEL of 25/14 mg/kg bw (equal to 320/160 ppm) in males/females. In the subchronic oral study in mice a LOAEL of 104/142 mg/kg bw (equal to 630/630 ppm) was noted in males/females. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3725c9b0-4738-4e1c-aa44-7551f3be4a86/documents/IUC5-731d4597-e004-4bc0-8343-750af8beb9ae_77900114-60ea-4bfe-891c-1db7df4878d6.html,,,,,, 2-ethylaminoethanol,110-73-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3725c9b0-4738-4e1c-aa44-7551f3be4a86/documents/IUC5-731d4597-e004-4bc0-8343-750af8beb9ae_77900114-60ea-4bfe-891c-1db7df4878d6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat 2-ethylaminoethanol,110-73-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3725c9b0-4738-4e1c-aa44-7551f3be4a86/documents/IUC5-731d4597-e004-4bc0-8343-750af8beb9ae_77900114-60ea-4bfe-891c-1db7df4878d6.html,Sub-chronic toxicity – systemic effects,dermal,LOAEL,32 mg/kg bw/day,,rat 2-ethylaminoethanol,110-73-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3725c9b0-4738-4e1c-aa44-7551f3be4a86/documents/IUC5-731d4597-e004-4bc0-8343-750af8beb9ae_77900114-60ea-4bfe-891c-1db7df4878d6.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,15 mg/m3,,rat 2-ethylaminoethanol,110-73-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3725c9b0-4738-4e1c-aa44-7551f3be4a86/documents/IUC5-731d4597-e004-4bc0-8343-750af8beb9ae_77900114-60ea-4bfe-891c-1db7df4878d6.html,Repeated dose toxicity – local effects,inhalation,NOAEC,3 mg/m3,adverse effect observed,rat 2-ethylaminoethanol,110-73-6,Acute oral toxicity studies have been performed in the rat and mouse; a supporting read-across study in the rat is also available.  Dermal toxicity studies in the rat and rabbit are available.  Two studies of acute inhalation toxicity in the rat are available. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3725c9b0-4738-4e1c-aa44-7551f3be4a86/documents/IUC5-3b9593a4-83e1-4a37-a4cb-4357fc5edbc3_77900114-60ea-4bfe-891c-1db7df4878d6.html,,,,,, 2-ethylaminoethanol,110-73-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3725c9b0-4738-4e1c-aa44-7551f3be4a86/documents/IUC5-3b9593a4-83e1-4a37-a4cb-4357fc5edbc3_77900114-60ea-4bfe-891c-1db7df4878d6.html,,oral,LD50,"1,073 mg/kg bw",adverse effect observed, 2-ethylaminoethanol,110-73-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3725c9b0-4738-4e1c-aa44-7551f3be4a86/documents/IUC5-3b9593a4-83e1-4a37-a4cb-4357fc5edbc3_77900114-60ea-4bfe-891c-1db7df4878d6.html,,dermal,LD50,"3,670 mg/kg bw",adverse effect observed, 2-ethylaminoethanol,110-73-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3725c9b0-4738-4e1c-aa44-7551f3be4a86/documents/IUC5-3b9593a4-83e1-4a37-a4cb-4357fc5edbc3_77900114-60ea-4bfe-891c-1db7df4878d6.html,,inhalation,LC50,"2,170 mg/m3",no adverse effect observed, Diethyl ether,60-29-7," An oral NOAEL of 500 mg/kg bw/day was reported for a 90-day rat study (US EPA). No other oral data are available. No dermal data are available.   The key inhalation study is considered to be a new study, requested by ECHA to be performed as subchronic inhalation study according to OECD 413 under GLP. In this study the NOAEL was reported as 1’500 ppm (high dose group in this study, i.e. ~ 4’500 mg/m³) in absence of any adverse effects observed.   This finding was supported by other studies of a structural similar substance di-isopropyl ether, mainly the study by Dalbey and Feuston (1996) in which a NOAEC of 3300 ppm (13800 mg/m³) was derived for subchronic (90-day). Further supportive inhalation effect levels include the following: NOAEC = 10000 ppm, rat, 35d (Stevens) NOEC = 2000 ppm, rat, 44d (Chenoweth) NOEC = 1000 ppm, guinea pig, 20d (Stevens) NOAEC = 2000 ppm, guinea pig, 43d (Chenoweth) NOEC = 1000 ppm, mouse, 20d (Stevens) NOEC = 2000 ppm, rabbit, 43d (Chenoweth) NOEC = 20000 ppm, rat, 90d (Reuzel, 1981) (read across from dimethyl ether) NOAEC = 20000 ppm, rat, 30 weeks (Collins, 1978) (read across from dimethyl ether) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53aa460b-84e8-4360-b987-9f6453938c72/documents/a0afdc08-a70b-42cd-8a7b-86f5cc8281a4_4cb92822-3f96-4f07-829d-865dd1e166b5.html,,,,,, Diethyl ether,60-29-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53aa460b-84e8-4360-b987-9f6453938c72/documents/a0afdc08-a70b-42cd-8a7b-86f5cc8281a4_4cb92822-3f96-4f07-829d-865dd1e166b5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,, Diethyl ether,60-29-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53aa460b-84e8-4360-b987-9f6453938c72/documents/a0afdc08-a70b-42cd-8a7b-86f5cc8281a4_4cb92822-3f96-4f07-829d-865dd1e166b5.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"4,500 mg/m3",,rat Diethyl ether,60-29-7," Oral, LD50 = 1200 - 1700 mg/kg bw, rat (Kimura) Oral, LD50 = 3560 mg/kg bw, rat (Smyth) Inhalation, LD50 = 97 mg/L, rat, male, 4h (Smyth) Inhalation, LC50 = 133 mg/L, mouse, 3h (Molitor) Inhalation, LD50 = 180/200 mg/L, mouse, male/female, 90 min (Kobayashi) Inhalation, LD50 = 95/98 mg/L, mouse, male/female, 90 min (Kobayashi) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53aa460b-84e8-4360-b987-9f6453938c72/documents/d8c9c772-7f66-4602-be2c-611af0428d46_4cb92822-3f96-4f07-829d-865dd1e166b5.html,,,,,, Diethyl ether,60-29-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53aa460b-84e8-4360-b987-9f6453938c72/documents/d8c9c772-7f66-4602-be2c-611af0428d46_4cb92822-3f96-4f07-829d-865dd1e166b5.html,,oral,LD50,"1,200 mg/kg bw",, Diethyl ether,60-29-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53aa460b-84e8-4360-b987-9f6453938c72/documents/d8c9c772-7f66-4602-be2c-611af0428d46_4cb92822-3f96-4f07-829d-865dd1e166b5.html,,inhalation,LC50,"97,000 mg/m3",, Ethyl formate,109-94-4,"Repeated dose oral NOAEL was considered to be 1000 mg/kg body weight/day when Osborne-Mendel male and female rats treated with test substance for 17 week by oral feed.   Repeated dose inhalation toxicity: Study 1 NOAEC was considered to 1 mg/L (330 ppm) when Sprague-Dawley male and female rats were inhaled with test substance for 90 days. Study 2: NOEC (NOEL) was considered to be 14 ppm when Sprague Dawley rats were exposed to test cigarette smoke by inhalation – nose only route.   Repeated dose dermal toxicity: 10 weeks repeated dermal study was conducted on male “s” strain mice with the dose concentration of 2760 mg/kg bw/day (0.3ml in acetone applied) and the histopathologic analysis is done to determine the toxic effects. No significant activity was observed In terms of epidermal hyperplasia. Therefore, NOAEL was considered to be 2760 mg/kg bw/day when male “s” strain mice were treated for 10 weeks. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Data is from peer-reviewed journal Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The data is K2 level and from publication Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Data is Klimisch 2 and from publication ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75bc26b9-fc66-48b4-9680-eb22d8ded5fb/documents/4da78d03-27e3-4892-9c0e-9a62979bb7c0_af892614-96dc-4f3e-9eb6-6a4dbe9cec9a.html,,,,,, Ethyl formate,109-94-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75bc26b9-fc66-48b4-9680-eb22d8ded5fb/documents/4da78d03-27e3-4892-9c0e-9a62979bb7c0_af892614-96dc-4f3e-9eb6-6a4dbe9cec9a.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,760 mg/kg bw/day",,mouse Ethyl formate,109-94-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75bc26b9-fc66-48b4-9680-eb22d8ded5fb/documents/4da78d03-27e3-4892-9c0e-9a62979bb7c0_af892614-96dc-4f3e-9eb6-6a4dbe9cec9a.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,1 mg/L,,rat Ethyl formate,109-94-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75bc26b9-fc66-48b4-9680-eb22d8ded5fb/documents/4da78d03-27e3-4892-9c0e-9a62979bb7c0_af892614-96dc-4f3e-9eb6-6a4dbe9cec9a.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Ethyl formate,109-94-4,"Acute oral toxicity:  The acute oral LD50 value was considered to be 1850 mg/kg, with 95% confidence limit of 1520-2240 mg/kg bw, when male and female Osborne-Mendel rats were treated with the given test chemical via oral gavage route.   Acute Inhalation toxicity:    Acute Inhalation toxicity dose (LC50) was considered based on different studies conducted on rats for the test chemical. The LC50 value was considered to be 28950 mg/m3. The study concluded that the LC50 value is >5 mg/L, for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute inhalation toxicity.   Acute Dermal toxicity:    Acute Dermal toxicity dose (LD50) was considered based on different studies conducted on rabbits for the test chemical. The LD50 value was considered to be >20000 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Data is Klimisch 1 and from study report. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Data is Klimisch 4 and from secondary source. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Data is Klimisch 2 and from publication. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75bc26b9-fc66-48b4-9680-eb22d8ded5fb/documents/f4542ad4-4496-488e-87bf-eff740178ca2_af892614-96dc-4f3e-9eb6-6a4dbe9cec9a.html,,,,,, Ethyl formate,109-94-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75bc26b9-fc66-48b4-9680-eb22d8ded5fb/documents/f4542ad4-4496-488e-87bf-eff740178ca2_af892614-96dc-4f3e-9eb6-6a4dbe9cec9a.html,,oral,LD50,"1,850 mg/kg bw",adverse effect observed, Ethyl formate,109-94-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75bc26b9-fc66-48b4-9680-eb22d8ded5fb/documents/f4542ad4-4496-488e-87bf-eff740178ca2_af892614-96dc-4f3e-9eb6-6a4dbe9cec9a.html,,dermal,LD50,"20,000 mg/kg bw",no adverse effect observed, Ethyl formate,109-94-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75bc26b9-fc66-48b4-9680-eb22d8ded5fb/documents/f4542ad4-4496-488e-87bf-eff740178ca2_af892614-96dc-4f3e-9eb6-6a4dbe9cec9a.html,,inhalation,LC50,"28,950 mg/m3",adverse effect observed, "Ethyl 3-[4-(hydroxymethyl)-2-methyl-1,3-dioxolan-2-yl]propanoate",902272-78-0, NOAEL (male/female) ≥ 1000 mg/kg/ day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2e5ab92-04e2-49b2-8a03-eed634ce324a/documents/687825e7-57e8-4298-919c-66933a6ae57d_407f82fb-6d93-4f84-9853-02c9ad703f5b.html,,,,,, "Ethyl 3-[4-(hydroxymethyl)-2-methyl-1,3-dioxolan-2-yl]propanoate",902272-78-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2e5ab92-04e2-49b2-8a03-eed634ce324a/documents/687825e7-57e8-4298-919c-66933a6ae57d_407f82fb-6d93-4f84-9853-02c9ad703f5b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Ethyl 3-[4-(hydroxymethyl)-2-methyl-1,3-dioxolan-2-yl]propanoate",902272-78-0, LD50 (oral) > 5000 mg/kg bw LD50 (dermal) > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2e5ab92-04e2-49b2-8a03-eed634ce324a/documents/9a278e50-d18e-478a-8363-5dbe03bee530_407f82fb-6d93-4f84-9853-02c9ad703f5b.html,,,,,, "Ethyl 3-[4-(hydroxymethyl)-2-methyl-1,3-dioxolan-2-yl]propanoate",902272-78-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2e5ab92-04e2-49b2-8a03-eed634ce324a/documents/9a278e50-d18e-478a-8363-5dbe03bee530_407f82fb-6d93-4f84-9853-02c9ad703f5b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Ethyl 3-[4-(hydroxymethyl)-2-methyl-1,3-dioxolan-2-yl]propanoate",902272-78-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2e5ab92-04e2-49b2-8a03-eed634ce324a/documents/9a278e50-d18e-478a-8363-5dbe03bee530_407f82fb-6d93-4f84-9853-02c9ad703f5b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl enantate,106-30-9, The test item is not toxic after repeated oral dosing. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22d7d3f7-6729-4c08-bcae-724f9f086beb/documents/be7a7067-d01d-4a93-b359-d7671342f0ad_60b5233a-4099-48b3-aa78-e20233c05edf.html,,,,,, Ethyl enantate,106-30-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22d7d3f7-6729-4c08-bcae-724f9f086beb/documents/be7a7067-d01d-4a93-b359-d7671342f0ad_60b5233a-4099-48b3-aa78-e20233c05edf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,097 mg/kg bw/day",,rat Ethyl enantate,106-30-9,The substance is not acute toxic. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22d7d3f7-6729-4c08-bcae-724f9f086beb/documents/3cf4aa0f-2120-4af7-8089-117117b8d199_60b5233a-4099-48b3-aa78-e20233c05edf.html,,,,,, Ethyl enantate,106-30-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22d7d3f7-6729-4c08-bcae-724f9f086beb/documents/3cf4aa0f-2120-4af7-8089-117117b8d199_60b5233a-4099-48b3-aa78-e20233c05edf.html,,oral,LD50,"34,640 mg/kg bw",no adverse effect observed, Ethyl enantate,106-30-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22d7d3f7-6729-4c08-bcae-724f9f086beb/documents/3cf4aa0f-2120-4af7-8089-117117b8d199_60b5233a-4099-48b3-aa78-e20233c05edf.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-ethylhexane-1,3-diol",94-96-2,No significant adverse effects were observed as a result of repeated dose exposure to EHD. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfe7347a-1317-4425-a602-5455f96bfb67/documents/IUC5-78ad8d1d-9412-41d6-a977-61e6039cf096_2b0b2d40-f5d2-49f0-933f-6d143886165a.html,,,,,, "2-ethylhexane-1,3-diol",94-96-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfe7347a-1317-4425-a602-5455f96bfb67/documents/IUC5-78ad8d1d-9412-41d6-a977-61e6039cf096_2b0b2d40-f5d2-49f0-933f-6d143886165a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2-ethylhexane-1,3-diol",94-96-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfe7347a-1317-4425-a602-5455f96bfb67/documents/IUC5-78ad8d1d-9412-41d6-a977-61e6039cf096_2b0b2d40-f5d2-49f0-933f-6d143886165a.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,884 mg/kg bw/day",,rat "2-ethylhexane-1,3-diol",94-96-2,The LD50 values for oral and dermal exposures are both greater than 2000 mg/kg bw/d. The LC50 value for inhalation was tested in a saturated atmosphere (up to 3.8 mg/L) with no findings of death or other significant toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfe7347a-1317-4425-a602-5455f96bfb67/documents/IUC5-9d9f5c33-c5ed-496b-b031-c3faa8465012_2b0b2d40-f5d2-49f0-933f-6d143886165a.html,,,,,, "2-ethylhexane-1,3-diol",94-96-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfe7347a-1317-4425-a602-5455f96bfb67/documents/IUC5-9d9f5c33-c5ed-496b-b031-c3faa8465012_2b0b2d40-f5d2-49f0-933f-6d143886165a.html,,oral,LD50,"4,636 mg/kg bw",adverse effect observed, "2-ethylhexane-1,3-diol",94-96-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfe7347a-1317-4425-a602-5455f96bfb67/documents/IUC5-9d9f5c33-c5ed-496b-b031-c3faa8465012_2b0b2d40-f5d2-49f0-933f-6d143886165a.html,,dermal,LD50,"8,960 mg/kg bw",adverse effect observed, "2-ethylhexane-1,3-diol",94-96-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfe7347a-1317-4425-a602-5455f96bfb67/documents/IUC5-9d9f5c33-c5ed-496b-b031-c3faa8465012_2b0b2d40-f5d2-49f0-933f-6d143886165a.html,,inhalation,LC50,"3,800 mg/m3",no adverse effect observed, Ethyl hexanoate,123-66-0," In the key Combined Repeated Dose Toxicity 28-day / Reproduction/Developmental Toxicity Screening Test in rats (OECD 422), the No Observed Adverse Effect Level (NOAEL) for the test item was 1000 mg/kg bw/day (top dose). These data were supported by the dose range finder study conducted in rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9de9442d-b261-4be8-8462-417ac8fc14b9/documents/4217b817-d6fa-4985-ac38-0e3e1b16ed2c_9b98398d-cf06-428b-9144-4b7cb26d944c.html,,,,,, Ethyl hexanoate,123-66-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9de9442d-b261-4be8-8462-417ac8fc14b9/documents/4217b817-d6fa-4985-ac38-0e3e1b16ed2c_9b98398d-cf06-428b-9144-4b7cb26d944c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Ethyl hexanoate,123-66-0," The test item has a low acute toxicity by the oral and dermal route. In rats, the LD50 value via the oral route is > 5000 mg/kg bw (value derived from Read -across compound Iso amyl isovalerate). In consideration of the molecular weight of both substances (172.27 and 144.21 g/mol), the corrected LD50 for the Ethyl caproate is > 4185.6 mg/kg. In rats, the LD50 value via the dermal route is > 2000 mg/kg bw (value derived from Read -across compound Ethyl propionate). In consideration of the molecular weight of both substances (144.21 and 102.13 g/mol), the corrected LD50 for the target substance is > 2824 mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9de9442d-b261-4be8-8462-417ac8fc14b9/documents/b410db28-d153-4e5d-8b45-c0cb955a4427_9b98398d-cf06-428b-9144-4b7cb26d944c.html,,,,,, Ethyl hexanoate,123-66-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9de9442d-b261-4be8-8462-417ac8fc14b9/documents/b410db28-d153-4e5d-8b45-c0cb955a4427_9b98398d-cf06-428b-9144-4b7cb26d944c.html,,oral,LD50,"4,185.6 mg/kg bw",no adverse effect observed, Ethyl hexanoate,123-66-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9de9442d-b261-4be8-8462-417ac8fc14b9/documents/b410db28-d153-4e5d-8b45-c0cb955a4427_9b98398d-cf06-428b-9144-4b7cb26d944c.html,,dermal,LD50,"2,824 mg/kg bw",no adverse effect observed, 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol,68140-98-7, The potential acute toxic effect of the test item 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol was tested according to OECD guideline 423.  The determined LD50 in rats is greater than 2000 mg/kg bw. No adverse effect was observed. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bf16d18-b203-42c3-a38f-822a15223a53/documents/56dcf368-451f-4f81-8b5f-7fe0b9152219_69a82aa8-8d52-4c9e-88dc-933f7dd0a99a.html,,,,,, 4-ethyl-2-(8-heptadecenyl)-2-oxazoline-4-methanol,68140-98-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bf16d18-b203-42c3-a38f-822a15223a53/documents/56dcf368-451f-4f81-8b5f-7fe0b9152219_69a82aa8-8d52-4c9e-88dc-933f7dd0a99a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-ethyl-3-hydroxy-4-pyrone,4940-11-8," Combined Chronic Toxicity/Carcinogenicity NOAEL (rat): >= 200 mg/kg bw/day, highest dose tested (Equivalent or similar to OECD 453). Combined Chronic Toxicity/Carcinogenicity NOAEL (dog): >= 200 mg/kg bw/day, highest dose tested (Equivalent or similar to OECD 453). Subchronic NOAEL (rat): 500 mg/kg bw/day (Equivalent or similar to OECD 408) Subchronic NOAEL (dog): 250 mg/kg bw/day (Equivalent or similar to OECD 409) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a9e5194-e983-4d9b-a679-d579b6c61574/documents/dde4fa30-7cd0-49a6-be59-bd9ef60265e7_875d2caa-76f5-4785-8b8e-600d5d841779.html,,,,,, 2-ethyl-3-hydroxy-4-pyrone,4940-11-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a9e5194-e983-4d9b-a679-d579b6c61574/documents/dde4fa30-7cd0-49a6-be59-bd9ef60265e7_875d2caa-76f5-4785-8b8e-600d5d841779.html,Chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat 2-ethyl-3-hydroxy-4-pyrone,4940-11-8, Acute oral toxicity: LD50  = 1220 mg/kg bw (with 95% CI 1000-1440 mg/kg bw) (Equivalent or similar to OECD 401)  Acute dermal toxicity: LD50 = >5000 mg/kg bw (Equivalent or similar to OECD 402) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a9e5194-e983-4d9b-a679-d579b6c61574/documents/c6970c96-d59d-4ffa-b35a-98f1a2a6e36b_875d2caa-76f5-4785-8b8e-600d5d841779.html,,,,,, 2-ethyl-3-hydroxy-4-pyrone,4940-11-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a9e5194-e983-4d9b-a679-d579b6c61574/documents/c6970c96-d59d-4ffa-b35a-98f1a2a6e36b_875d2caa-76f5-4785-8b8e-600d5d841779.html,,oral,LD50,"1,220 mg/kg bw",adverse effect observed, 2-ethyl-3-hydroxy-4-pyrone,4940-11-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a9e5194-e983-4d9b-a679-d579b6c61574/documents/c6970c96-d59d-4ffa-b35a-98f1a2a6e36b_875d2caa-76f5-4785-8b8e-600d5d841779.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Ethyl isovalerate,108-64-5," In a combined repeated dose toxicity 28-day / Reproduction/Developmental Toxicity Screening Test in rats (OECD 422), the No Observed Adverse Effect Level (NOAEL) for 3 -methylbutyl isovalerate as a Read-across substance was 800 mg/kg bw/day (top dose). In consideration of the molecular weight of both source and target substances (172.27 and 130.19 g/mol) the No Observed Adverse Effect Levels (NOAELs) for general toxicity effects and reproduction/developmental toxicity was 604.6 mg/kg/day. Using this read across approach, the target substance is not classified for long term toxicity endpoints according to CLP. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/529438d3-3b39-45b3-bf36-d200e7be009e/documents/713f3fde-1a1f-4239-aa9b-b6045a870f56_90de42b8-d1f1-4506-852a-d72e41241f35.html,,,,,, Ethyl isovalerate,108-64-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/529438d3-3b39-45b3-bf36-d200e7be009e/documents/713f3fde-1a1f-4239-aa9b-b6045a870f56_90de42b8-d1f1-4506-852a-d72e41241f35.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,604.6 mg/kg bw/day,,rat Ethyl isovalerate,108-64-5," The test item has a low acute toxicity by the oral and dermal route. In rats, the LD50 value via the oral route is > 5000 mg/kg bw (value derived from Read -across compound 3 -methylbutyl isovalerate). In consideration of the molecular weight of both substances (172.27 and 130.18 g/mol), the corrected LD50 for Ethyl isovalerate is > 3778.66 mg/kg. In rats, the LD50 value via the dermal route is > 2000 mg/kg bw (value derived from Read -across compound ethyl propionate). In consideration of the molecular weight of both substances (102.13 and 130.18 g/mol), the corrected LD50 for the target substance is >2548mg/kg. No abnormalities were observed during the studies. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/529438d3-3b39-45b3-bf36-d200e7be009e/documents/7a719eb1-870d-4c57-84e5-90d39bfaa948_90de42b8-d1f1-4506-852a-d72e41241f35.html,,,,,, Ethyl isovalerate,108-64-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/529438d3-3b39-45b3-bf36-d200e7be009e/documents/7a719eb1-870d-4c57-84e5-90d39bfaa948_90de42b8-d1f1-4506-852a-d72e41241f35.html,,oral,LD50,"3,778.66 mg/kg bw",no adverse effect observed, Ethyl isovalerate,108-64-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/529438d3-3b39-45b3-bf36-d200e7be009e/documents/7a719eb1-870d-4c57-84e5-90d39bfaa948_90de42b8-d1f1-4506-852a-d72e41241f35.html,,dermal,LD50,"2,548 mg/kg bw",no adverse effect observed, Ethyl 4-oxovalerate,539-88-8," LD50 (oral) > 2000 mg/kg bw (rat, female) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c986e70d-acf3-456c-9028-746f02f3480a/documents/77f9cee3-d596-4c61-8aa5-0de64d38dcb2_de6ad3d9-aa4d-4cbb-9c7e-064e03f3af71.html,,,,,, Ethyl 4-oxovalerate,539-88-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c986e70d-acf3-456c-9028-746f02f3480a/documents/77f9cee3-d596-4c61-8aa5-0de64d38dcb2_de6ad3d9-aa4d-4cbb-9c7e-064e03f3af71.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, ethyl N2-dodecanoyl-l-argininate hydrochloride,60372-77-2," Several studies have been assessed for Oral Repeated dose toxicity with durations according to: 28 days, 90 days and 52 weeks. In general doses have been well tolerated. However, the key study to assess a NOAEL effect was the Chronic study in rats developed during 52 weeks. The corresponding LOAEL was 18000 ppm equivalent to 907 mg/kg bw and 1128 mg/kg bw/day for the males and females respectively, based on local irritant changes in the forestomach. Based on the calculated intake data, the NOAEL in this study was 6000 ppm equivalent to 307 mg/kg bw/day in the males and 393 mg/kg bw/day in the females. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b61bb26-d00d-41ef-9610-0cb974eebdcb/documents/IUC5-6db326f5-aa6d-4d9e-a8a0-158bcda82c8a_3b4b8677-63b4-4d70-a4e6-4b06fb624343.html,,,,,, ethyl N2-dodecanoyl-l-argininate hydrochloride,60372-77-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b61bb26-d00d-41ef-9610-0cb974eebdcb/documents/IUC5-6db326f5-aa6d-4d9e-a8a0-158bcda82c8a_3b4b8677-63b4-4d70-a4e6-4b06fb624343.html,Chronic toxicity – systemic effects,oral,NOAEL,307 mg/kg bw/day,,rat ethyl N2-dodecanoyl-l-argininate hydrochloride,60372-77-2, The oral LD50 for the Nα-Lauroyl-L-arginine ethyl ester monohydrochloride (LAE) is greater than 2000 mg/kg/bw. The dermal LD50 for the Nα-Lauroyl-L-arginine ethyl ester monohydrochloride (LAE) is greater than 2000 mg/kg/bw. The inhalation LC50 for the Nα-Lauroyl-L-arginine ethyl ester monohydrochloride (LAE) is greater than 5883 mg/m3 air ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b61bb26-d00d-41ef-9610-0cb974eebdcb/documents/IUC5-6abb044f-66ef-45be-a13a-e603f5452f69_3b4b8677-63b4-4d70-a4e6-4b06fb624343.html,,,,,, ethyl N2-dodecanoyl-l-argininate hydrochloride,60372-77-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b61bb26-d00d-41ef-9610-0cb974eebdcb/documents/IUC5-6abb044f-66ef-45be-a13a-e603f5452f69_3b4b8677-63b4-4d70-a4e6-4b06fb624343.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, ethyl N2-dodecanoyl-l-argininate hydrochloride,60372-77-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b61bb26-d00d-41ef-9610-0cb974eebdcb/documents/IUC5-6abb044f-66ef-45be-a13a-e603f5452f69_3b4b8677-63b4-4d70-a4e6-4b06fb624343.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, ethyl N2-dodecanoyl-l-argininate hydrochloride,60372-77-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b61bb26-d00d-41ef-9610-0cb974eebdcb/documents/IUC5-6abb044f-66ef-45be-a13a-e603f5452f69_3b4b8677-63b4-4d70-a4e6-4b06fb624343.html,,inhalation,discriminating conc.,"5,883 mg/m3",no adverse effect observed, "3,7-dimethylnona-1,6-dien-3-ol",10339-55-6,"28-day oral toxicity study in rat (linalool), NOAEL: 117 mg/kg bw/day 90-day dermal toxicity study in rat (linalool), NOAEL: 250 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be33b208-a6d4-4cbe-b275-9f61238ede74/documents/IUC5-a716176e-43dc-49b6-88eb-dc6589630e6a_54b334e9-66da-4641-96f9-a6087ca23944.html,,,,,, "3,7-dimethylnona-1,6-dien-3-ol",10339-55-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be33b208-a6d4-4cbe-b275-9f61238ede74/documents/IUC5-a716176e-43dc-49b6-88eb-dc6589630e6a_54b334e9-66da-4641-96f9-a6087ca23944.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,117 mg/kg bw/day,,rat "3,7-dimethylnona-1,6-dien-3-ol",10339-55-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be33b208-a6d4-4cbe-b275-9f61238ede74/documents/IUC5-a716176e-43dc-49b6-88eb-dc6589630e6a_54b334e9-66da-4641-96f9-a6087ca23944.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,250 mg/kg bw/day,,rat "3,7-dimethylnona-1,6-dien-3-ol",10339-55-6,Acute toxicity oral:- The oral LD50 in mice for ethyllinalool was determined to be 5283 mg/kg bw.- The oral LD50 in rats for ethyllinalool was determined to be 5000 mg/kg bw.Acute toxicity inhalation:- The inhalative LC50 in rats for dehydrolinalool was determined to be greater than 1.0 mg/l.- The inhalative LC50 in mice for linalool was determined to be greater than 3.2 mg/l.Acute toxicity dermal:- The dermal LD50 in rabbits for ethyllinalool was determined to be greater than 5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be33b208-a6d4-4cbe-b275-9f61238ede74/documents/IUC5-fbb43ac0-ab67-41ba-8339-a176affb0570_54b334e9-66da-4641-96f9-a6087ca23944.html,,,,,, "3,7-dimethylnona-1,6-dien-3-ol",10339-55-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be33b208-a6d4-4cbe-b275-9f61238ede74/documents/IUC5-fbb43ac0-ab67-41ba-8339-a176affb0570_54b334e9-66da-4641-96f9-a6087ca23944.html,,oral,LD50,"5,283 mg/kg bw",no adverse effect observed, "3,7-dimethylnona-1,6-dien-3-ol",10339-55-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be33b208-a6d4-4cbe-b275-9f61238ede74/documents/IUC5-fbb43ac0-ab67-41ba-8339-a176affb0570_54b334e9-66da-4641-96f9-a6087ca23944.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Ethyl linoleate,544-35-4,"RA: 91051-53-5:LD50(oral) > 2000 mg/kg bw. (BASF, 2010)LD50(dermal) > 2000 mg/kg bw. (BASF, 2010) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e908525-ac7b-46bc-9f1d-9b6a75ec2218/documents/IUC5-b42a505a-f161-4ff4-bb80-0da94f817937_d2846783-4a05-435d-a788-19ec5ba557e3.html,,,,,, N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide,39711-79-0," Repeated dose toxicity: Oral In a 22-week study, groups of 15 Sprague-Dawley (CFY) rats of each sex were given the test chemical by gavage at a dose of 0, 100, 300 or 725 mg/kg bw. The parameters examined were mortality, Clinical signs, body weight, food efficiency, Urinalysis, Haematology, Biochemistry, organ weight, Opthalmoscopy, Gross pathology and histopathology. After initial dosing, but not thereafter, several males were lethargic and had mild hypothermia, ataxia and lachrymation, and two females at the highest dose were semi-comatose. Throughout the study, mild transient salivation was noted in rats at the highest dose and to a lesser extent in those at 300 mg/kg bw per day. At the end of the second week and for the remainder of the study, rats at the highest dose and a few at the intermediate dose showed reduced grooming activity. Several rats had mild sialodacryoadenitis during weeks 8-12. One male and one female at the highest dose died at week 4; however, the deaths were probably the result of an intubation error. Another male at the highest dose was killed because of ocular haemorrhage after orbital blood sampling. One male at the intermediate dose was found dead during week 12 with signs of lung congestion. An additional 11 treated rats died during the last 3 weeks of the study, probably due to blood sampling error. Significantly reduced body-weight gain was also reported in females at the highest dose, and rats at the highest dose continued to show lower weight gain during the last 9 weeks. No significant variations were found in food consumption between test and control rats; however, during the first 3 months, males at the two higher doses had a dose-related reduction in growth rate. The reduced body-weight gain observed at the highest dose was accompanied by a reduction in feed use efficiency from week 5 of the study. The only variations in haematological parameters reported were in males at weeks 12, 13, 15 and 22, which showed increased blood clotting times in thrombo tests in comparison with controls; however, this effect was thought to be a result of tissue fluid contamination, and therefore additional blood samples were collected by cardiac puncture at weeks 21 and 22. At week 21, the thrombo test values for rats at the two lower doses were below the upper normal limit; although the values for animals at the highest dose remained above the normal limits of variation, the values were markedly reduced from previous weeks. At week 22, a further improvement was noted in thrombotest values in blood collected by cardiac puncture in comparison with values in blood obtained from the orbital sinus. Statistically significant variations in clinical chemistry at week 6 were limited to a reduction in serum alkaline phosphatase activity in animals at the highest dose in comparison with controls; however, the values were within the normal limits of variation. Clinical chemistry parameters examined at week 12 revealed the following statistically significant changes: increased plasma glucose and serum sodium levels, decreased serum alkaline phosphatase activity in males at the highest dose and increased total serum protein levels in both sexes. In an extension of the study, serum protein was also increased in rats of each sex at the two lower doses. At weeks 6 and 7, urine samples from controls and animals at the two higher doses contained leukocytes; however, none were seen at week 12. Epithelial cells were reported in urine samples taken at weeks 6 and 7, but not at week 12. Females at the highest dose had a dose-related increase in specific gravity with no change in urine volume at weeks 7 and 12, whereas males had an increase in volume output with no change in specific gravity. An increased urinary volume was observed in males at the intermediate dose at week 13. Additionally, reducing substances were found in the urine of females with increasing frequency over the test period. Dose-related variations in organ weights were limited to significant increases in the absolute and relative liver weights of females in all test groups in comparison with controls ,and significantly elevated relative liver weights in males at the highest dose. All other variations in organ weights were considered to be incidental or to reflect body weight differences and, as such, were not deemed to be toxicologically significant. The results of gross examinations were unremarkable. Although histopathological examination revealed some changes in cardiac and pulmonary tissues and in the livers in all groups of animals, the changes were typical of this strain of laboratory rat and considered not to be related to treatment. Based on the observations made, no observed adverse effect level (NOAEL) for the test chemical to Sprague Dawley male rat was considered to be 300 mg/kg bw/day while to female rat it was considered to be <100 mg/kg bw/day after repeated exposure via oral route. Repeated dose toxicity: Inhalation N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide (CAS no 39711-79-0) has very low vapor pressure of 0.0072 Pa (5.4004433e-5 mm Hg), so the potential for the generation of inhalable vapours is very low, also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route of exposure was considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value for 3 N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide (CAS no 39711-79-0) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb9f65fa-ab38-4600-ad52-98d02555c71b/documents/e37a5098-a840-470d-8ef4-ad42c13e3bd8_413bea8f-a288-46ed-a1d5-d031ee9759d7.html,,,,,, N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide,39711-79-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb9f65fa-ab38-4600-ad52-98d02555c71b/documents/e37a5098-a840-470d-8ef4-ad42c13e3bd8_413bea8f-a288-46ed-a1d5-d031ee9759d7.html,Chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide,39711-79-0," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is 2900 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0072 Pa (5.4004433e-5 mm Hg). Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rabbits for the test chemical. The LD50 value is >5000 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb9f65fa-ab38-4600-ad52-98d02555c71b/documents/c28a42f2-3685-41be-b9b3-ae80407887e9_413bea8f-a288-46ed-a1d5-d031ee9759d7.html,,,,,, N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide,39711-79-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb9f65fa-ab38-4600-ad52-98d02555c71b/documents/c28a42f2-3685-41be-b9b3-ae80407887e9_413bea8f-a288-46ed-a1d5-d031ee9759d7.html,,oral,LD50,"2,900 mg/kg bw",no adverse effect observed, N-ethyl-2-(isopropyl)-5-methylcyclohexanecarboxamide,39711-79-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb9f65fa-ab38-4600-ad52-98d02555c71b/documents/c28a42f2-3685-41be-b9b3-ae80407887e9_413bea8f-a288-46ed-a1d5-d031ee9759d7.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, 5-methylheptan-3-one oxime,22457-23-4,oral and dermal studies shown to be above limits for classification ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe151fb2-cf42-4025-871b-9ace16ffe6a2/documents/IUC5-a0aa30fe-866a-417a-a34a-31d7b9452377_2b43af88-1908-46e4-9bf5-d04daa1c51dc.html,,,,,, 5-methylheptan-3-one oxime,22457-23-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe151fb2-cf42-4025-871b-9ace16ffe6a2/documents/IUC5-a0aa30fe-866a-417a-a34a-31d7b9452377_2b43af88-1908-46e4-9bf5-d04daa1c51dc.html,,oral,LD50,"3,200 mg/kg bw",no adverse effect observed, 5-methylheptan-3-one oxime,22457-23-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe151fb2-cf42-4025-871b-9ace16ffe6a2/documents/IUC5-a0aa30fe-866a-417a-a34a-31d7b9452377_2b43af88-1908-46e4-9bf5-d04daa1c51dc.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Ethyl 2,3-epoxy-3-phenylbutyrate",77-83-8,Rat oral 2 yr NOAEL - 0.1 % in diet (non-guideline study); rat oral 16 wk NOAEL < 1 % (non-guideline study); rat oral 1 yr NOAEL ≥ 0.25 % (non-guideline study); rat oral 90 day NOAEL - 0.1 % in diet (non-guideline study). ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e12cb9a-6f23-4adf-ab84-1e859c1d4a75/documents/IUC5-9b1a4caf-903b-4ae0-b805-1db7d7893929_88bdb560-5404-44e0-9e2b-895188bec505.html,,,,,, "Ethyl 2,3-epoxy-3-phenylbutyrate",77-83-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e12cb9a-6f23-4adf-ab84-1e859c1d4a75/documents/IUC5-9b1a4caf-903b-4ae0-b805-1db7d7893929_88bdb560-5404-44e0-9e2b-895188bec505.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Ethyl 2,3-epoxy-3-phenylbutyrate",77-83-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e12cb9a-6f23-4adf-ab84-1e859c1d4a75/documents/IUC5-9b1a4caf-903b-4ae0-b805-1db7d7893929_88bdb560-5404-44e0-9e2b-895188bec505.html,Chronic toxicity – systemic effects,oral,NOAEL,35 mg/kg bw/day,,rat "Ethyl 2,3-epoxy-3-phenylbutyrate",77-83-8,"Oral: Rat oral acute LD₅₀ 5470 mg/kg bw (non-guideline); guinea pig oral acute LD₅₀ 4050 mg/kg bw (non-guideline); Rat oral acute LD₅₀ >5000 mg/kg bw (non-guideline).Dermal: Rat dermal acute LD₅₀ > 2000 mg/kg bw (OECD 402); rabbit dermal acute LD₅₀ >5000 mg/kg bw (non-guideline).Inhalation: waiver: Regulation EC No. 1907/2006, Annex VIII, specifies when testing is necessary: ""Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size."" Although this is a fragrance substance and intended to be inhaled it is used in very small concentrations in finished product by consumers. The vapour pressure of the substance is 0.23 Pa at 20 °C. This is considered low and therefore consumer exposure via inhalation is unlikely.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e12cb9a-6f23-4adf-ab84-1e859c1d4a75/documents/IUC5-242bf1e4-4e0b-4dbb-bbbd-433a6bea98db_88bdb560-5404-44e0-9e2b-895188bec505.html,,,,,, "Ethyl 2,3-epoxy-3-phenylbutyrate",77-83-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e12cb9a-6f23-4adf-ab84-1e859c1d4a75/documents/IUC5-242bf1e4-4e0b-4dbb-bbbd-433a6bea98db_88bdb560-5404-44e0-9e2b-895188bec505.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Ethyl 2,3-epoxy-3-phenylbutyrate",77-83-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e12cb9a-6f23-4adf-ab84-1e859c1d4a75/documents/IUC5-242bf1e4-4e0b-4dbb-bbbd-433a6bea98db_88bdb560-5404-44e0-9e2b-895188bec505.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Ethyl octanoate,106-32-1, The test item is not toxic after repeated dosing. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b35ea369-7513-461e-931e-ca22aba5d5b7/documents/b54f6e7e-61d1-4351-864c-c4f9e0466062_adf75583-0006-4fb7-bcc7-8d25408313fb.html,,,,,, Ethyl octanoate,106-32-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b35ea369-7513-461e-931e-ca22aba5d5b7/documents/b54f6e7e-61d1-4351-864c-c4f9e0466062_adf75583-0006-4fb7-bcc7-8d25408313fb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,194 mg/kg bw/day",,rat Ethyl octanoate,106-32-1,The substance is not acute oral or acute dermal toxic. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b35ea369-7513-461e-931e-ca22aba5d5b7/documents/130846b9-a5c3-44e2-b846-4302e094ff50_adf75583-0006-4fb7-bcc7-8d25408313fb.html,,,,,, Ethyl octanoate,106-32-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b35ea369-7513-461e-931e-ca22aba5d5b7/documents/130846b9-a5c3-44e2-b846-4302e094ff50_adf75583-0006-4fb7-bcc7-8d25408313fb.html,,oral,LD50,"5,973 mg/kg bw",no adverse effect observed, Ethyl octanoate,106-32-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b35ea369-7513-461e-931e-ca22aba5d5b7/documents/130846b9-a5c3-44e2-b846-4302e094ff50_adf75583-0006-4fb7-bcc7-8d25408313fb.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18 and C18-unsatd., Et esters",85049-36-1,The available repeated dose toxicity study (90-day) resulted in a NOAELs of 5500 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8d4ed63-21f0-4e92-9f00-a673b1a0e7d8/documents/IUC5-602d99fe-48b5-438e-a09e-aed8c6f742a9_e5120c61-5c28-4fcd-a709-70631513fdd0.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., Et esters",85049-36-1,"Acute toxicity: Oral LD50 (rat, m/f): > 4360 mg/kg bw (OECD 401, analogue approach)Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, analogue approach) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8d4ed63-21f0-4e92-9f00-a673b1a0e7d8/documents/IUC5-6be4ddcb-c35d-4f1b-b99b-5f1a88f314b6_e5120c61-5c28-4fcd-a709-70631513fdd0.html,,,,,, Ethyl palmitate,628-97-7," Based on the available studies for repeated toxicity assessment and according to the category approach, the NOAEL for the target substance was defined to be higher than 1000 mg/kg bw/day. No adverse effect or mortality was observed in the studies. Hence, according to the CLP criteria, the ethyl palmitate was not classified for STOT-RE. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79751f39-2c1d-4f9d-a20d-88d875140b45/documents/16af377d-6322-45bd-945a-3428ddfcaeb4_b3764f9a-6123-4a06-8207-268057f2460e.html,,,,,, Ethyl palmitate,628-97-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79751f39-2c1d-4f9d-a20d-88d875140b45/documents/16af377d-6322-45bd-945a-3428ddfcaeb4_b3764f9a-6123-4a06-8207-268057f2460e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Ethyl palmitate,628-97-7," Based on the available studies performed on the source substances of the category, the LD50 was defined to be higher than 2000 mg/kg bw for the target substance, ethyl palmitate. Hence, the substance was not classified for Acute Toxicity according to CLP criteria. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79751f39-2c1d-4f9d-a20d-88d875140b45/documents/aa965042-7f6c-4827-9291-234cf014cf8e_b3764f9a-6123-4a06-8207-268057f2460e.html,,,,,, Ethyl palmitate,628-97-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79751f39-2c1d-4f9d-a20d-88d875140b45/documents/aa965042-7f6c-4827-9291-234cf014cf8e_b3764f9a-6123-4a06-8207-268057f2460e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl palmitate,628-97-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79751f39-2c1d-4f9d-a20d-88d875140b45/documents/aa965042-7f6c-4827-9291-234cf014cf8e_b3764f9a-6123-4a06-8207-268057f2460e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Ethyl 3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoate",5413-49-0, NOAEL (male/female) ≥ 1000 mg/kg/ day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da3f441d-927f-405a-ac1b-54595c81d681/documents/1c624790-c56b-497e-9616-af722a38519b_0a30aaa0-9ee6-4520-8f81-f99e2a55a8c3.html,,,,,, "Ethyl 3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoate",5413-49-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da3f441d-927f-405a-ac1b-54595c81d681/documents/1c624790-c56b-497e-9616-af722a38519b_0a30aaa0-9ee6-4520-8f81-f99e2a55a8c3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Ethyl 3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoate",5413-49-0, LD50 (oral) > 5000 mg/kg bw LD50 (dermal) > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da3f441d-927f-405a-ac1b-54595c81d681/documents/b9cf20a8-6430-4e09-ac81-1893b710940e_0a30aaa0-9ee6-4520-8f81-f99e2a55a8c3.html,,,,,, "Ethyl 3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoate",5413-49-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da3f441d-927f-405a-ac1b-54595c81d681/documents/b9cf20a8-6430-4e09-ac81-1893b710940e_0a30aaa0-9ee6-4520-8f81-f99e2a55a8c3.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Ethyl 3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoate",5413-49-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da3f441d-927f-405a-ac1b-54595c81d681/documents/b9cf20a8-6430-4e09-ac81-1893b710940e_0a30aaa0-9ee6-4520-8f81-f99e2a55a8c3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, [2-(1-ethoxyethoxy)ethyl]benzene,2556-10-7, Repeated dose toxicity - oral (OECD TG 422): NOAEL ≥377 mg/kg bw/day (highest dose tested) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb950627-3b29-441d-b1a4-0f628890d37a/documents/58545e14-c7e5-47d0-91ae-6b46b6a463bd_273522d5-1c50-477e-b7c8-1687dfea30a0.html,,,,,, [2-(1-ethoxyethoxy)ethyl]benzene,2556-10-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb950627-3b29-441d-b1a4-0f628890d37a/documents/58545e14-c7e5-47d0-91ae-6b46b6a463bd_273522d5-1c50-477e-b7c8-1687dfea30a0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,377 mg/kg bw/day,,rat [2-(1-ethoxyethoxy)ethyl]benzene,2556-10-7, Acute oral toxicity (OECD TG 401): LD50 >5000 mg/kg bw Acute dermal toxicity (OECD TG 402): LD50 >5000 mg/kg/ bw Acute inhalation toxicity using route to route extrapolation from the oral route: > 13000 mg/m3 ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb950627-3b29-441d-b1a4-0f628890d37a/documents/ad579c75-a8e6-4fe8-ad1a-4598cbd5ae76_273522d5-1c50-477e-b7c8-1687dfea30a0.html,,,,,, Ethyl phenylacetate,101-97-3, In a combined repeated dose oral gavage toxicity study with the reproduction/developmental toxicity screening with the test item (CAS 101 -97 -3) the No-Observed-Adverse-Effect Level (NOAEL) for general toxicity was considered to be 200 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65d85dd1-6b4b-430f-bbd9-64c915a4d36e/documents/5ed543d4-dd2b-4080-b8c0-3a9f451432a3_d575e9ac-ee3e-40d8-9094-58f310d1b393.html,,,,,, Ethyl phenylacetate,101-97-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65d85dd1-6b4b-430f-bbd9-64c915a4d36e/documents/5ed543d4-dd2b-4080-b8c0-3a9f451432a3_d575e9ac-ee3e-40d8-9094-58f310d1b393.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Ethyl phenylacetate,101-97-3,In an acute oral toxicity study the LD50 was determined to be 3300 mg/kg bw.In an acute dermal toxicity study the LD50 was determined to be >5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65d85dd1-6b4b-430f-bbd9-64c915a4d36e/documents/a13798cd-7516-4809-8759-a0edab06b8e9_d575e9ac-ee3e-40d8-9094-58f310d1b393.html,,,,,, Ethyl phenylacetate,101-97-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65d85dd1-6b4b-430f-bbd9-64c915a4d36e/documents/a13798cd-7516-4809-8759-a0edab06b8e9_d575e9ac-ee3e-40d8-9094-58f310d1b393.html,,oral,LD50,"3,300 mg/kg bw",adverse effect observed, Ethyl phenylacetate,101-97-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65d85dd1-6b4b-430f-bbd9-64c915a4d36e/documents/a13798cd-7516-4809-8759-a0edab06b8e9_d575e9ac-ee3e-40d8-9094-58f310d1b393.html,,dermal,discriminating dose,"5,000 mg/kg bw",adverse effect observed, "Silicic acid, ethyl ester",11099-06-2," Repeated dose toxicity: Oral Based on the data available, the No Observed Adverse Effect Level (NOAEL) for the test chemical was considered to be in range of 50 -200 mg/Kg bw using male and female rats. Hence the test chemical is not likely to be toxic upon repeated exposure by oral route as per the criteria mentioned in CLP regulation. Repeated dose toxicity: inhalation Based on the data available, the No Observed Adverse Effect concentration (NOAEC) for the test chemical was considered to be in range of 147-200000 mg/m³using male rats or mice . Hence the test chemical is not likely to be toxic upon repeated exposure by inhalation route as per the criteria mentioned in CLP regulation. Repeated dose toxicity: dermal The acute toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcf97cc7-ed7e-4c16-b342-028c7aa39afd/documents/57abd98a-0ade-405e-897e-bd099fdc7729_c9d4fb31-e809-4fbe-909f-2a1b602a8736.html,,,,,, "Silicic acid, ethyl ester",11099-06-2,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcf97cc7-ed7e-4c16-b342-028c7aa39afd/documents/57abd98a-0ade-405e-897e-bd099fdc7729_c9d4fb31-e809-4fbe-909f-2a1b602a8736.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,147 mg/m3,,rat "Silicic acid, ethyl ester",11099-06-2,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcf97cc7-ed7e-4c16-b342-028c7aa39afd/documents/57abd98a-0ade-405e-897e-bd099fdc7729_c9d4fb31-e809-4fbe-909f-2a1b602a8736.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Silicic acid, ethyl ester",11099-06-2," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is 7500 mg/kg bw. The study concluded that LD50 is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity dose (LC50) was considered based on different studies conducted on rats for the given test chemical. The LC50 value is 20000 mg/m3. The study concluded that LC50 value is >5 mg/L(>5000 mg/m3), for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute inhalation toxicity. Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rabbits for the given test chemical. The LD50 value is 4290 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcf97cc7-ed7e-4c16-b342-028c7aa39afd/documents/2b8f9df6-9996-46b7-a684-2a244e84ba50_c9d4fb31-e809-4fbe-909f-2a1b602a8736.html,,,,,, "Silicic acid, ethyl ester",11099-06-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcf97cc7-ed7e-4c16-b342-028c7aa39afd/documents/2b8f9df6-9996-46b7-a684-2a244e84ba50_c9d4fb31-e809-4fbe-909f-2a1b602a8736.html,,oral,LD50,"7,500 mg/kg bw",no adverse effect observed, "Silicic acid, ethyl ester",11099-06-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcf97cc7-ed7e-4c16-b342-028c7aa39afd/documents/2b8f9df6-9996-46b7-a684-2a244e84ba50_c9d4fb31-e809-4fbe-909f-2a1b602a8736.html,,dermal,LD50,"4,290 mg/kg bw",no adverse effect observed, "Silicic acid, ethyl ester",11099-06-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcf97cc7-ed7e-4c16-b342-028c7aa39afd/documents/2b8f9df6-9996-46b7-a684-2a244e84ba50_c9d4fb31-e809-4fbe-909f-2a1b602a8736.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, Ethyl propionate,105-37-3," In the key combined repeated dose with the reproduction/developmental toxicity screening test in rats (OECD 422), the No Observed Adverse Effect Level (NOAEL) for Ethyl caproate as a Read across substance was up to 1000 mg/kg bw/day (top dose). In consideration of the molecular weight of both substances (144.21 and 102.13 g/mol) No-Observed-Adverse-Effect-Levels (NOAELs) for general toxicity effects and reproduction/developmental toxicity are considered to be at least 708 mg/kg/day. Using this read across approach, the target substance was not to be classified for long term toxicity endpoints according to CLP. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9fb881d-430d-4498-82f9-a044e3c3c8a5/documents/ed8b07a6-4a4a-4baf-ac11-efe3c69cb1a5_f6471af4-319e-4192-93c0-651709ad98a5.html,,,,,, Ethyl propionate,105-37-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9fb881d-430d-4498-82f9-a044e3c3c8a5/documents/ed8b07a6-4a4a-4baf-ac11-efe3c69cb1a5_f6471af4-319e-4192-93c0-651709ad98a5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,708 mg/kg bw/day,,rat Ethyl propionate,105-37-3," The test item has a low acute toxicity by the oral and dermal routes. The available inhalation data support a classification of the test substance according to CLP as STOT SE 3 (H335). In rats, the LD50 value via the oral route is > 5000 mg/kg bw (value derived from read-across compound isoamyl isovalerate). In consideration of the molecular weight of both substances (172.27 and 102.13 g/mol), the corrected LD50 for the Ethyl propionate is > 2964.2 mg/kg. In rats, the LD50 value via the dermal route is > 2000 mg/kg bw. In an acute inhalation toxicity study in rats LT50s of 35 and 32 minutes were reported in male and female rats, respectively. Effects observed included laboured breathing, lethargy, ataxia, lacrimation, discharge (nasal, oral) and loss of reflexes. Gross pathology observations included red lungs, gas-filled stomachs and liquid-filled tracheas. The vapor concentration applied (210 mg/l) was ten times higher than the CLP classification threshold for inhalation acute toxic Category 4 of 20 mg/l. Therefore a classification for acute inhalation toxicity is not justified. The lethal effects found in the animals are nevertheless considered serious enough to apply a classification as STOT SE 3 (H335) according to CLP. It is known that highly soluble esters can hydrolyse fast in aqueous solution. Hydrolysis products of the parent substance are ethanol and propionic acid, with propionic acid having higher potency for local lung effects. The formation of propionic acid is therefore considered causing the observed effects in this study. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9fb881d-430d-4498-82f9-a044e3c3c8a5/documents/384b2233-5636-4de6-bb1f-22c23db3308b_f6471af4-319e-4192-93c0-651709ad98a5.html,,,,,, Ethyl propionate,105-37-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9fb881d-430d-4498-82f9-a044e3c3c8a5/documents/384b2233-5636-4de6-bb1f-22c23db3308b_f6471af4-319e-4192-93c0-651709ad98a5.html,,oral,LD50,"2,964.2 mg/kg bw",no adverse effect observed, Ethyl propionate,105-37-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9fb881d-430d-4498-82f9-a044e3c3c8a5/documents/384b2233-5636-4de6-bb1f-22c23db3308b_f6471af4-319e-4192-93c0-651709ad98a5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-ethylpyrrolidin-2-one,2687-91-4," Oral administration: In a subchronic oral study, administration of N-Ethyl-2 -pyrrolidone caused substance-related adverse effects at 1000 and 300 mg/kg bw/day in both sexes of rats and 100 mg/kg bw/day or higher in males (BASF, 2006). Detailed clinical examinations in an open field were conducted prior to the start of the administration period and weekly thereafter. Afunctional observational battery (FOB) and measurement of motor activity was carried out. Vaginal smears for estrus cycle determination of all female animals were prepared and evaluated each day during the last 4 weeks of the study. Clinicochemical, hematological examinations and urinalyses were performed towards the end of the administration period. Ophthalmological examinations were performed before and towards the end of the administration period. All animals were assessed by gross pathology, followed by histopathological examinations. Additionally, sperm parameters were determined immediately after necropsy and organ weight determination.  No effects were observed in females at 100 mg/kg bw/day. Food consumption, body weight, grip strength was reduced at 1000 and 300 mg/kg bw/day. Target organs were the liver in both sexes (centrilobular hypertrophy of hepatocyctes liver weight increase) and the kidney in males (alpha 2u globuline which was confirmed immunohistochemically). Histomorphologically, a centrilobular hypertrophy of hepatocytes could be correlated to the increased liver weights in both sexes. In males, a centrilobular hypertrophy was noted for the mid (300 mg/kg bw/day) and low (100 mg/kg bw/day) dose groups, although dose-dependently less pronounced. In females, no centrilobular hypertrophy was noted in the mid and low dose groups. The centrilobular hypertrophy of hepatocytes is indicative for an enzyme induction of the cytochrome P450 system and is considered to be a detoxifying, adaptive effect (no signs for cytotoxicity recorded). Kidney effects in male rats at 100 mg/kg bw/day or higher are considered not relevant to humans as they are due to a rat specific mechanism. Sperm analysis revealed an increased number of sperms with abnormal heads in males at 1000 mg/kg bw/day. The most common sperm head anomalies were abnormal hooks and amorphous heads. These results are indicative of disrupted sperm maturation, when the test compound is administered at high dosages. This effect was not associated with any histopathological changes in the testis and did not affect the number of homogenization resistant spermatids, epididymal sperm count and sperm motility. The reproductive organs in females were not affected. Beyond these findings, there were some effects on clinical chemistry and hematology parameters observed at 1000 mg/kg/day. Therefore, the overall no observed adverse effect level (NOAEL) under the conditions of this study was 100 mg/kg bw/day for females and the lowest observed adverse effect level (LOAEL 300 mg/kg bw/day) and below 100 mg/kg bw/day for males (critical effect: alpha 2u nephropathy, which is considered not to be relevant to humans). Inhalative administration: In a 28 -day study according to OECD 412, 10 male and 5 female rats per dose group received doses of 0, 80, 200, and 400 mg/m3 as a liquid aerosol with vapor fraction via nose/head-only inhalation exposure for 4 weeks on 5 consecutive days per week and 6 h per day (BASF, 2011). A concurrent control group was exposed to air. On each exposure day a clinical examination was performed before, during and after exposure. Body weights and food consumption of the animals were determined weekly. On the day after the last exposure, blood was sampled and examined for a range of hematology and clinical chemical parameters as indicated in the guideline. After blood sampling the animals were sacrificed and subject to necropsy (including macroscopic examination of the major internal organs and collection of organ weight data). Selected tissues were processed histopathologically and were evaluated by light microscopy. Histological examinations were performed in respiratory tract, liver and testes according to standardized methods. During the exposure period the animals of the control group and low concentration (80 mg/m³) showed no clinical signs and findings different from normal. During the exposure period several animals of the intermediate and high concentration (200 mg/m³) showed abnormal clinical signs including salivation, red encrusted nose, nose discharge, lacrimation of eyes. These signs were only observed directly after the daily exposure period and fully reversible before the start of next exposure. On the post-exposure observation day all animals were free of clinical signs. No treatment-related changes among clinical chemistry parameters, body weight, food consumption, or hematology were measured. The degeneration/ regeneration of the olfactory epithelium in animals of the mid and high dose group was regarded to be treatment-related. Furthermore most animals of the high dose group showed minimal focal epithelial alteration of cuboidal cells in the larynx at the base of epiglottis (level I). In females, a treatment-related effect cannot be ruled out. All other findings were considered to be incidental or spontaneous in origin and without any relation to treatment. Thus, under the test conditions of this 28 day-study, the NOAEC for local effect in nasal cavity was 80 mg/m3 while the NOAEC for systemic effects was 400 mg/m3. In an inhalation study over 90 days (65 exposures) according to OECD TG 413, 10 male and 10 female rats per dose group were exposed to vapor for 6 hours per day on 5 consecutive days at concentrations of 0, 30, 60, and 200 mg/m3 of the test item via nose/head-only inhalation exposure (BASF, 2013). On each exposure day a clinical examination was performed before, during and after exposure.Detailed clinical observation was performed at the beginning, midterm and end of the study. Ophthalmology was performed before the beginning of the exposure in all test groups and at the end of the end of the exposure in the control and high concentration group animals. Body weights and food consumption of the animals were determined weekly. At the end of the exposure period, functional observation battery and motor activity tests were performed. Against the end of the exposure period, urine was collected in all animals and were analyzed according to the guidelines. On the day after the last exposure, blood was sampled and examined for a range of hematology and clinical chemical parameters as indicated in the guideline. After blood sampling the animals were sacrificed and subject to necropsy (including macroscopic examination of the major internal organs and collection of organ weight data). In addition, sperm motility and total sperm head count (testis and caudal epididymides) was assessed. Selected tissues were processed histopathologically and were evaluated by light microscopy according to the OECD guideline. The inhalation exposure did not lead to any exposure-related clinical signs of toxicity nor were there any effect in clinical chemistry, hematology, urine and sperm parameters. Regarding pathology the target organ was the nasal cavity. Histological examination revealed signs of degeneration and regeneration of the olfactory epithelium at the highest tested concentration of 200 mg/m3. Multifocal tubular degeneration in the testes occurred in control and treated males without relation to the concentration resulting in debris and/or oligospermia in the epididymides in some of these males (see table 5). Comparable findings in testes and in the epididymides have been observed frequently in head-nose exposed control animals in past inhalation studies in the same laboratory. Therefore, the occurrence of tubular degeneration as well as of the resulting debris and oligospermia in the epididymides in this inhalative subchronic study was considered to be incidental. All other pathological findings were considered to be incidental or spontaneous in origin and without relation to treatment. Therefore, under the current test conditions, the NOAEC for local effect in nasal cavity was at the mid concentration 60 mg/m3 and for systemic toxicity at the high concentration 200 mg/m3. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12760377-cfcc-4e62-948a-50ab209b5585/documents/d1bbd51e-b577-4785-a325-8edfdb895ac5_672fd49b-ccd8-46ce-ae11-f5e045eab984.html,,,,,, 1-ethylpyrrolidin-2-one,2687-91-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12760377-cfcc-4e62-948a-50ab209b5585/documents/d1bbd51e-b577-4785-a325-8edfdb895ac5_672fd49b-ccd8-46ce-ae11-f5e045eab984.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 1-ethylpyrrolidin-2-one,2687-91-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12760377-cfcc-4e62-948a-50ab209b5585/documents/d1bbd51e-b577-4785-a325-8edfdb895ac5_672fd49b-ccd8-46ce-ae11-f5e045eab984.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,200 mg/m3,,rat 1-ethylpyrrolidin-2-one,2687-91-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12760377-cfcc-4e62-948a-50ab209b5585/documents/d1bbd51e-b577-4785-a325-8edfdb895ac5_672fd49b-ccd8-46ce-ae11-f5e045eab984.html,Repeated dose toxicity – local effects,inhalation,NOAEC,60 mg/m3,adverse effect observed,rat 1-ethylpyrrolidin-2-one,2687-91-4, 1-Ethyl-pyrrolidin-2 -one (NEP) is practically non-toxic after acute inhalative or dermal exposure. After ingestion NEP is of low acute toxicity. LD50 (rat; oral) : 3200 mg/kg LC50 (rat; inhal.): > 5.1 mg/l/4h LD50 (rat; dermal): > 2000 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12760377-cfcc-4e62-948a-50ab209b5585/documents/d8082158-7a0c-4df7-9e76-3a33805dda80_672fd49b-ccd8-46ce-ae11-f5e045eab984.html,,,,,, Ethyl pyruvate,617-35-6, Acute oral LD50 of ethyl pyruvate in a vehicle of corn oil is greater than 5000 mg/kg in male and female Sprague-Dawley rats. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6017056a-5c9d-4963-9dac-4ebb9e89a33d/documents/0bd4630a-fc7c-4698-a1ef-7269d0ea8f6b_2c6ccecf-87a7-44dc-b021-8fa04feb772a.html,,,,,, Ethyl pyruvate,617-35-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6017056a-5c9d-4963-9dac-4ebb9e89a33d/documents/0bd4630a-fc7c-4698-a1ef-7269d0ea8f6b_2c6ccecf-87a7-44dc-b021-8fa04feb772a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Ethyl salicylate,118-61-6," For this enpoint, one key study is available for acute oral toxicity. No data are available on acute toxicity via inhalation or dermal application. The study has been performed in rats. It did not follow a guideline and was pre-GLP. Each group of 10 rats were fed orally 0.34, 0.67, 1.31, 2.56 or 5.0 g/kg of test substance as a single dose. The animals were observed for 14 days. As a result, the test substance can be referred to as a category 4 compound with an LD50 of 1320 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f64e24f-1f08-4f3f-b8fb-51ae13246ce2/documents/f4398553-f1a8-4cff-9810-4946348b946a_99ac29d1-4d6c-46bb-9c13-3adfbe911576.html,,,,,, Ethyl salicylate,118-61-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f64e24f-1f08-4f3f-b8fb-51ae13246ce2/documents/f4398553-f1a8-4cff-9810-4946348b946a_99ac29d1-4d6c-46bb-9c13-3adfbe911576.html,,oral,LD50,"1,320 mg/kg bw",adverse effect observed, "4-ethyl-2,2,4,6,6-pentamethyl-3,5-dioxa-2,4,6-trisilaheptane",17861-60-8,"In a repeated dose toxicity study performed according to OECD 407 and GLP principles, a NOAEL of 50 mg/kg bw/day was determined for 3-ethylheptamethyltrisiloxane.   . ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05e2a6c9-6d2e-464a-b46a-581b1a789be7/documents/479204bb-400b-4f41-acaa-bf5e8c6a91bf_a53fb8c1-73da-4761-9e5f-60243a3dc21c.html,,,,,, "4-ethyl-2,2,4,6,6-pentamethyl-3,5-dioxa-2,4,6-trisilaheptane",17861-60-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05e2a6c9-6d2e-464a-b46a-581b1a789be7/documents/479204bb-400b-4f41-acaa-bf5e8c6a91bf_a53fb8c1-73da-4761-9e5f-60243a3dc21c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "4-ethyl-2,2,4,6,6-pentamethyl-3,5-dioxa-2,4,6-trisilaheptane",17861-60-8,"The substance was tested according to OECD guidelines 423 (oral), 403 (inhalation) and 402 (dermal). No adverese effects were observed in the three studies. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05e2a6c9-6d2e-464a-b46a-581b1a789be7/documents/ea4ea2f5-b972-46a2-86f2-402e2b6d2a18_a53fb8c1-73da-4761-9e5f-60243a3dc21c.html,,,,,, "4-ethyl-2,2,4,6,6-pentamethyl-3,5-dioxa-2,4,6-trisilaheptane",17861-60-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05e2a6c9-6d2e-464a-b46a-581b1a789be7/documents/ea4ea2f5-b972-46a2-86f2-402e2b6d2a18_a53fb8c1-73da-4761-9e5f-60243a3dc21c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-ethyl-2,2,4,6,6-pentamethyl-3,5-dioxa-2,4,6-trisilaheptane",17861-60-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05e2a6c9-6d2e-464a-b46a-581b1a789be7/documents/ea4ea2f5-b972-46a2-86f2-402e2b6d2a18_a53fb8c1-73da-4761-9e5f-60243a3dc21c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-ethyl-2,2,4,6,6-pentamethyl-3,5-dioxa-2,4,6-trisilaheptane",17861-60-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05e2a6c9-6d2e-464a-b46a-581b1a789be7/documents/ea4ea2f5-b972-46a2-86f2-402e2b6d2a18_a53fb8c1-73da-4761-9e5f-60243a3dc21c.html,,inhalation,LC50,> 10 mg/L,no adverse effect observed, 3-ethoxy-4-hydroxybenzaldehyde,121-32-4,"Two studies have been selected as key study, a 90 day study and an OECD 421 study. In the 13-week study (Huntingdon et al. , 1992) performed on rats, the NOAEL is 1000 mg/kg bw/day based on spleen weight which is higher than control group (relative) related with histopathological changes. In the OECD 421 study performed by gavage in 2017 (Charles River, 2017), transient but adverse clinical signs were observed in male and female rats at the dose level of 1000 mg/kg/day. A NOAEL of 500 mg/kg/day was therefore identified for these effects. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Good quality. This NOAEL has been identified from an OECD 421 study performed in 2017 with reliability 1. The results observed on this study are consistent with the results from the other available repeated toxicity studies and give the lower NOAEL. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/265476c4-e2a6-4461-8f9c-b2011c1bcb61/documents/33805381-b06b-4c5b-adcd-f9f5bcb617ee_2e004208-c322-4c8f-9753-2d2dc4a4161f.html,,,,,, 3-ethoxy-4-hydroxybenzaldehyde,121-32-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/265476c4-e2a6-4461-8f9c-b2011c1bcb61/documents/33805381-b06b-4c5b-adcd-f9f5bcb617ee_2e004208-c322-4c8f-9753-2d2dc4a4161f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat 3-ethoxy-4-hydroxybenzaldehyde,121-32-4,Oral LD50 > 3160 mg/kgDermal LD 50 > 2000 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/265476c4-e2a6-4461-8f9c-b2011c1bcb61/documents/28767a0f-6501-48ee-8a7b-4c3f9577e635_2e004208-c322-4c8f-9753-2d2dc4a4161f.html,,,,,, 3-ethoxy-4-hydroxybenzaldehyde,121-32-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/265476c4-e2a6-4461-8f9c-b2011c1bcb61/documents/28767a0f-6501-48ee-8a7b-4c3f9577e635_2e004208-c322-4c8f-9753-2d2dc4a4161f.html,,oral,LD50,"> 3,160 mg/kg bw",no adverse effect observed, 3-ethoxy-4-hydroxybenzaldehyde,121-32-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/265476c4-e2a6-4461-8f9c-b2011c1bcb61/documents/28767a0f-6501-48ee-8a7b-4c3f9577e635_2e004208-c322-4c8f-9753-2d2dc4a4161f.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Ethyl 2-methyl-1,3-dioxolane-2-acetate",6413-10-1," Oral NOAEL = 1000 mg/kg bw/day (male/female, rat), OECD 422, Spézia (2013) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efd7f77e-494a-4094-840b-e0441d4b9c7d/documents/IUC5-901020b9-4a49-4e2d-892c-dd6dde5c80cd_7c0ff6b9-b357-4a86-8c62-698bea1680ff.html,,,,,, "Ethyl 2-methyl-1,3-dioxolane-2-acetate",6413-10-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efd7f77e-494a-4094-840b-e0441d4b9c7d/documents/IUC5-901020b9-4a49-4e2d-892c-dd6dde5c80cd_7c0ff6b9-b357-4a86-8c62-698bea1680ff.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Ethyl 2-methyl-1,3-dioxolane-2-acetate",6413-10-1," ORAL LD50 > 5.0 g/kg, rat, Moreno (1980 & 1978) DERMAL LD50 > 5.0 g/kg, rabbit, Moreno (1980 & 1978) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efd7f77e-494a-4094-840b-e0441d4b9c7d/documents/IUC5-e7c4039e-8fc2-4f03-9207-513f457a7897_7c0ff6b9-b357-4a86-8c62-698bea1680ff.html,,,,,, "Ethyl 2-methyl-1,3-dioxolane-2-acetate",6413-10-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efd7f77e-494a-4094-840b-e0441d4b9c7d/documents/IUC5-e7c4039e-8fc2-4f03-9207-513f457a7897_7c0ff6b9-b357-4a86-8c62-698bea1680ff.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Ethyl 2-methyl-1,3-dioxolane-2-acetate",6413-10-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efd7f77e-494a-4094-840b-e0441d4b9c7d/documents/IUC5-e7c4039e-8fc2-4f03-9207-513f457a7897_7c0ff6b9-b357-4a86-8c62-698bea1680ff.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Diethoxymethane,462-95-3," DNEL have been derived from the NOAEL of 3000 ppm (or 12753 mg/m3) coming from the 12-day exposure inhalation toxicity study performed with ethylal (Katz, 1987). This value has been used as the worst case in comparison with supporting NOAEC of 6300 mg/m3 coming from the read-across (90 day inhalation study with methylal_Hofman, 1994). NOAEL coming from study of Katz (1987) is the worst-case due to extapolation from 14d to 90 day duration, leading to an extrapolation factor of 12 in DNEL calculation (2 for 14d to subacute and 6 for subacute to chronic exposure). An absenc eof adverse effect has been observed in a 22d repeated dose inhalation perform with 1000 ppm of methylal (Rutsky, 1996), supporting the relevance of shorter duration studies. Note that these studies (2 with methylal and 1 with ethylal) are characterised by an absence of adverse effects by inhalation route, supporting the same toxicokinetic profile of methyal and etyhlal. It is important to note that no alert has been found among the mechanistic profilers relevant for repeated dose toxicity in the read-across report with source methylal and target ethylal, supporting the similarity of toxicokinetic behavious of both compounds (Pavan, 2016). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/124b8e89-b924-44b9-b50a-dee474fa7a6c/documents/IUC5-b7b3ded9-7c44-44d8-b7b1-1a5990863167_180d3da9-0dbb-4b98-a17f-86884d97c882.html,,,,,, Diethoxymethane,462-95-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/124b8e89-b924-44b9-b50a-dee474fa7a6c/documents/IUC5-b7b3ded9-7c44-44d8-b7b1-1a5990863167_180d3da9-0dbb-4b98-a17f-86884d97c882.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"12,573 mg/m3",,rat Diethoxymethane,462-95-3,Not classified for Acute toxicity ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/124b8e89-b924-44b9-b50a-dee474fa7a6c/documents/IUC5-9b351c02-af0f-48ad-a400-7f964f96db80_180d3da9-0dbb-4b98-a17f-86884d97c882.html,,,,,, Diethoxymethane,462-95-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/124b8e89-b924-44b9-b50a-dee474fa7a6c/documents/IUC5-9b351c02-af0f-48ad-a400-7f964f96db80_180d3da9-0dbb-4b98-a17f-86884d97c882.html,,oral,LD50,"3,536 mg/kg bw",no adverse effect observed, Diethoxymethane,462-95-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/124b8e89-b924-44b9-b50a-dee474fa7a6c/documents/IUC5-9b351c02-af0f-48ad-a400-7f964f96db80_180d3da9-0dbb-4b98-a17f-86884d97c882.html,,dermal,LD50,"20,000 mg/kg bw",no adverse effect observed, Diethoxymethane,462-95-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/124b8e89-b924-44b9-b50a-dee474fa7a6c/documents/IUC5-9b351c02-af0f-48ad-a400-7f964f96db80_180d3da9-0dbb-4b98-a17f-86884d97c882.html,,inhalation,LC50,0.032 mg/m3,no adverse effect observed, Ethylbenzene,100-41-4,"Oral route Data obtained after oral exposure support the main findings of inhalation studies. The most comprehensive investigation is that of Mellert et al. (2007) (BASF, 2004) exposing rats by gavage at levels of 75, 250 and 750 mg/kg bw/d over 90 days. Body weight was significantly decreased in males at 750 mg/kg bw/ d. Liver and kidney weights were increased at 250 and 750 mg/kg bw/d accompanied by slight centrolobular hypertrophy, those in the kidney are characterised as chronic progressive nephropathy and accumulation of male specific protein a-2u-globulin. In addition at the two top dose levels there was a slight increase of serum alanine aminotransferase and gamma-glutamyltransferase in males and signs for a minimal regenerative anemia. Increases in total bilirubin and mild increase in hemosiderosis (observed for 1-phenylethanol only) might indicate on a mild hemolysis as possible cause of anemia. Overall, the NOAEL was 75 mg/kg bw/d.   Dermal route   No information is available for systemic toxicity after repeated dermal exposure.   Inhalation route   A number of conventional toxicology studies on rats, mice and rabbits with repeated inhalation exposures are available. Additional data but of deficient quality were reported on inhalation exposure in rhesus monkeys and guinea pigs.   Clinical signs indicative of irritation were reported in rats starting at about 400 ppm with a NOEC of 100 ppm (Cragg et al., 1989; Biodynamics, 1986) with similar signs of irritation in mice at 400 ppm (Biodynamics, 1986). Slight body weight depressions in rats started at about 750 ppm (Stott et al.,1999; 2003; NTP, 1992) in studies up to 3 months of duration, while after an exposure period of 2 years (NTP, 1999) such slight effects on body weights were already observed at 250 ppm in rats but not in mice. Mortality was increased after 4 days of exposure in rats at 2400 ppm and in mice at 1200 ppm (Biodynamics, 1986) while after a 2-year exposure there was a decreased survival of male rats at 750 ppm (but not in female rats or mice), most probably related to chronic progressive nephropathy (CPN) (NTP, 1999).   The most consistent effect is an increase in liver weight of rats and mice without histopathological alterations by standard procedures in studies with duration up to 3 months (Cragg et al., 1989; Biodynamics, 1986; Stott et al., 1999;2003; Wolf et al., 1956; NTP, 1992, WIL Research Laboratories, 2004; Faber et al, 2006). Such effects were also noted in studies dealing with fertility (cf section 4.1.2.9), e.g. in parental animals of a 1- generation (WIL Research Laboratories, Inc., 2003) and 2 -generation study (WIL Research Laboratories, Inc., 2005)and in a non guideline investigation on female fertility (Andrew et al., 1981; Hardin et al., 1981). Liver changes most probably are related to enzyme induction as has been demonstrated by several authors (Stott et al., 1999; 2003; Elovaara et al., 1985; Toftgard, Nilsen, 1982). This is supported by a proliferation of smooth endoplasmatic reticulum (Elovaara et al., 1985). An increase in kidney weight was also found. A detailed histopathological reevaluation of the kidneys of rats exposed for 3 months in the NTP (1992) study revealed a dose-related increase of the severity of CPN in male rats at 750 and 1000 ppm, but not in females. In addition, an increase in incidence of hyaline droplets was observed at these dose levels in male rats (Hard, 2002). CPN in rats has no specific relevance for humans and liver enzyme induction is not to be considered as a toxicological relevant effect for human risk assessment. The NOEC for all of these findings is 100 ppm and the NOAEC in the most relevant 90 day NTP study (1992) for extrapolation to humans is 1000 ppm (4.74 mg/l).   Similar organ-related systemic toxicity was observed after 2 years of exposure (NTP, 1999). In rats a detailed histopathological reexamination again revealed chronic progressive nephropathy at 750 ppm markedly in male and modestly in female rats in all treated groups. There was a high incidence of severe CPN with kidney alterations that may lead to renal failure. Cystic degeneration of the liver was increased in 750 ppm males, but the biological significance in the absence of other hepatotoxic changes is unclear. In mice there was a spectrum of non neoplastic liver changes for both males and females. Histopathological findings related to lung tumor formation will be reported in the section on carcinogenicity. A detailed reevaluation of the lung and liver slices from mice basically confirmed the original NTP findings (Brown, 2000). Hyperplastic changes were also reported for the thyroid in males and females at 750 ppm and for the pituitary in females starting at 250 ppm. In summary, as chronic progressive nephropathy has no toxicological relevance for human risk assessment, the NOAEC for rats was 250 ppm in males and 750 ppm in females if small reductions (5-6%) in body weight (males at 250 ppm and females at all exposure levels) for females are not taken into account. In mice the NOAEC was 75 ppm for males and females based on liver, lung, thyroid and pituitary pathology.   Organ-specific toxicity (effects on the nervous system)   In experimental animals ethylbenzene exposure induced various effects on the central nervous system:   Effects on neurotransmitters   Two studies reported modulation of neuronal transmitters at 2000 ppm (Andersson et al., 1981) or 750 ppm (Romanelli et al., 1986; Mutti and Franchini, 1987; Mutti et al., 1988), respectively, over a few days. Furthermore, at 2000 ppm a decrease of prolactin in serum was observed(Andersson et al., 1981). However, the significance of these effects is unclear.   Depressive and narcotic effects   Although depressive or narcotic effects have been observed in humans by aromatic solvents in general, the animal data are less consistent showing transient effects for ethylbenzene only at very high acute exposures.   In a 90 day oral guideline study specifically designed for the detection of neurotoxic effects dose levels up to 500 mg/kg bw/d did not lead to findings indicative of neurotoxicity in rats (Li et al., 2010).   The results of in vitro tests indicate that ethylbenzene may affect the regulatory functions of astrocytes (Naskali et al., 1994;Vaalavirta and Tähti, 1995).   It may be suspected that ethylbenzene could lead to lesions in the central nervous system similar to other organic solvents. But no indications for such morphological alterations of the central nervous system have been reported in other animal experiments including the 2-year bioassay with exposures up to 750 ppm (NTP, 1999).But because of the limited reliability of standard H&E staining for detecting neurological disorders this is not sufficient proof for the absence of minor morphological abnormalities.   Ototoxicity   Vyskocil et al.(2008) reviewed the literature for ethylbenzene induced effects on the auditory system. In workers, they found no evidence on either ethylbenzene related hearing losses or ototoxic interaction after combined exposure to ethylbenzene and noise. But given the current evidence from animal studies they recommend that ethylbenzene should be considered also as an ototoxic agent for humans.   Ethylbenzene leads to ototoxicity in rats. Persistent hearing loss in the mid-frequency range was confirmed in a series of auditory tests in rats (sound-evoked electrical responses, otoacoustic emissions, behavioral auditory tests) corresponding to a concentration dependent death of sensory cells (outer hair cells – OHC, especially in the 3rdrow) in the upper basal and middle turns of the cochlea. Outer hair cell death determined by histopathology is the most sensitive endpoint for auditory effects (Cappaert et al., 2000; Gagnaire et al., 2007). For death of outer hair cells 200 ppm was a LOEC and the NOEC was calculated to be 114 ppm (95% confidence limit) (Gagnaire et al., 2007). With increasing ethylbenzene concentrations the other endpoints for ototoxicity become affected, too, and OHC death spreads over the frequency range in the cochlea and from row 3 to row 2 and 1 of the outer hair cells. OHC death as confirmed by histopathology indicates that hearing loss is irreversible. This is substantiated by Cappaert et al. (1999) since hearing loss did not change between 1 and 4 weeks post exposure to 800 ppm over 5 days. On the other hand, electrophysiological investigations did not show any further deterioriation of auditory function when exposure to 400 ppm was prolonged from 4 over 8 up to 13 weeks (Gagnaire et al., 2007). Auditory loss remained at the same level following additional 8 weeks of recovery. This might indicate that OHC loss at this concentration was already complete at week 4 and was irreversible.   Comparable ototoxic effects were observed in rats that were repeatedly receiving etyhlbenzene via the oral route (Gagnaire and Langlais, 2005), which is in line with the experience gained from other aromatic solvents (e.g., styrene). Since only one concentration of ethylbenzene was examined, (900 mg/kg, 5 d/wk/2 weeks), a N/LOAEL could not be estimated. Other oral tests, also those following OECD standard study designs, did not include specific auditory examinations. By comparison between behavioral and electrophysiological methods Cappaert et al. (1999)concluded that ethylbenzene primarily exerts its effects on the peripheral part of the auditory system.   In a comparative study with different aromatic solvents given orally by gavage ethylbenzene belonged to the most potent ototoxicants together with styrene by means of OHC death. The potency was higher than that of toluene and p-xylene. Gagnaire et al. (2007) found that ototoxicity in mixed exposure to xylenes and ethylbenzene mainly depends on the concentration of ethylbenzene and auditory loss was higher in combined exposure than after single exposure to same ethylbenzene concentrations.   Experiments with combined exposure to noise and ethylbenzene indicated to a synergistic effect of both (Cappaert et al., 2001). In the other experiment of Fechter et al. (2007) a very high exposure to the solvent mixture used (660 ppm ethylbenzene + 400 ppm toluene) (without noise) did not result in adverse hearing effects in contrast to all the other studies with ethylbenzene, while hearing loss was reported for the combination of this solvent mixture with noise exposure of 93-95 dB. Actually no explanation for this unexpected result could be given. As synergistic effects were also known from mixed exposure to other aromatic solvents, the outcome of this study appears questionable.   By comparison with rats, guinea pigs are very insensitive against ethylbenzene-induced ototoxicity (Cappaert et al., 2002). The low sensitivity of guinea pigs was attributed to the low blood concentration of ethylbenzene in comparison to that of rats.   The critical question is whether ototoxicity of ethylbenzene in humans is best comparable to that in the rat rather to that seen in the guinea pig. Until the exact position of humans within the inter-species ranking of susceptibility to ethylbenzene-induced ototoxicity is actually known, data from the rat are to be taken as relevant for humans. This assumption is supported by a number of reports on hearing deficits in humans occupational exposed to organic solvents or from people after solvent abuse (for review cf Risk Assessment Reports on toluene and styrene).   Ethylbenzene belongs to the most ototoxic aromatic solvents, its potency being comparable to that of styrene but higher than those of toluene or p-xylene. Comparing rat data on the lowest effective concentrations for ethylbenzene and toluene, the risk of ototoxicity is expected to be higher for ethylbenzene.   Irreversible damage of auditory function and of sensory cells of the cochlea is a serious health damage. After 13 weeks of exposure minimal effects were still observed at 200 ppm (0.88 mg/l) and the NOEC was extrapolated to 114 ppm (0.5 mg/l).    With regard to DNEL derivation three aspects have to be critically evaluated: 1.     Influence of exposure duration on NOAEC 2.     Sensitivity of histopathological and (electro)physiological effects 3.     Anatomical/histological differences of target tissues between rats and humans.   1. Influence of exposure duration on NOAEC Ototoxicity leading to an increase of audiometric threshold and specific histopathological alterations with destruction of the outer hair cells in the cochlea (predominantly in row 3) is not a specific effect only of ethylbenzene, but has been described for a variety of other aromatic solvents. In a comparative oral study such histopathological effects were observed for alpha-methylstyrene, trans-beta-methylstyrene, toluene, p-xylene, n-propyl­benzene, styrene, and allylbenzene apart from ethylbenzene after oral application (Gagnaire and Langlais, 2005). After inhalation exposure qualitatively similar hearing impairments were found by reflex modification audiometry for styrene, toluene and mixed xylenes (Crofton et al., 1994). The inhalation of styrene and toluene again led to similar electrophysiological and histopathological findings (Loquet et al., 1999). Permanent hearing loss as determined by behavioral and electrophysiological methods was also described after inhalation exposure to toluene (Pryor et al., 1984), mixed xylenes, and styrene (Pryor et al., 1987).   The weight of evidence obtained from experiments with styrene and other aromatic solvents indicates that ototoxicity is exerted by the lipophilic aromatic parent chemical rather than by a metabolite: -   Similar ototoxic effects were found for a range of lipophilic organic solvents. As all of these chemicals are biotransformed to different metabolites, indirect evidence is thereby obtained that the parent chemicals themselves most probably lead to ototoxicity - When rats were exposed to toluene, pre-treatment with phenobarbital prior to toluene inhalation resulted in a marked reduction in blood toluene levels and prevented hearing loss (Pryor et al., 1991) showing induction of metabolism reduces ototoxicity. -   A comparative study of ototoxicity in rats and guinea pigs showed much higher blood levels of styrene in the rat (i.e. 23 µg/g) leading to ototoxicity, while in the guinea pig the blood levels were about 4-fold lower (i.e. about 5 µg/g) with no evidence of ototoxicity (Lataye et al., 2003). This finding compares well with that of Cappaert et al. (2002) attributing the low sensitivity of guinea pigs for ototoxicity against ethylbenzene to the low blood concentration of the parent chemical in comparison to rats. -   Inhalation to toluene induced auditory impairment as determined by auditory brainstem response in rats but not in chinchillas under similar exposure conditions. This was explained by species differences in hepatic microsomal metabolism of toluene being highest in chinchillas (Davis et al., 2002) - No changes in auditory brainstem response were seen in rats treated with phenylglyoxylic acid, a major metabolite of styrene and ethylbenzene, in drinking water over 3 months at doses up to 5000 mg/l, corresponding to 293 mg/kg bw/d (Ladefoged et al., 1998) - The higher sensitivity of young rats as compared to old ones for ototoxicity was explained by Lataye et al. (2004) by age related increases in styrene metabolism   In conclusion, the overall evidence indicates that the mechanism of aromatic solvent induced ototoxicity is very similar for these chemicals, notwithstanding different potencies, and driven by the parent compound and not by their hydrophilic metabolites. A read across approach is therefore indicated to fill specific data gaps for the risk assessment of ethylbenzene   There is strong evidence that the maximum of hearing impairment is already reached after one to a few weeks of exposure and that ototoxicity does not increase with prolongation of the exposure period. Campo P. (2001) exposed rats to 1000 ppm styrene (6h/d, 5d/week) for 1, 2, 3, or 4 consecutive weeks. Permanent hearing loss was observed using electrophysiological examinations 6 weeks after the end of each exposure period. An exposure duration of 1 week was enough to obtain the maximal hearing deficit without any further increase by prolongation of exposure. This was confirmed by histopathology of the cochlea carried out 6 weeks post-exposure: hair cell loss was virtually the same after an exposure duration of 1 or 3 weeks.   The conclusion that maximal hearing impairment is already reached after a few weeks of exposure can also be indirectly inferred by comparison of the results of The Dow Chemical Company (1992) and Maekitie et al. (2003). The Dow Chemical Company (1992) exposed male Fisher-344 rats (6h/d, 5d/week) to 0, 50, 200 and 800 ppm styrene over 13 weeks. Effects on the auditory system were determined by electrophysiology and histopathology of the cochlea a few days after the end of exposure. Clear effects were noted at an exposure of 800 ppm and the NOAEC was 200 ppm. This compares well to the NOAEC of 300 ppm determined in male Wistar rats by Maekitie et al. (2003)after an exposure to 0, 100, 300 and 600 ppm (12h/d, 5d/week) over only 4 weeks.   The conclusion that solvent induced ototoxicity already appears after a relatively short exposure duration and that continued exposure does not enhance the intensity of the response or reduces the NOAEC is also supported by studies with toluene. In a review Johnson and Nylen (1995) described for toluene that a time-integrated concentration between 12000 and 16000 ppm x h/d over 3 days was sufficient to cause loss of auditory sensitivity, while 6000 ppm x h/d over 18 month failed to produce ototoxic effects. Pryor et al. (1984) showed that a 2 week exposure to 1000 ppm toluene (14h/d, 7d/week) produced ototoxicity in Fischer rats while no effects were seen for a similar exposure schedule over 16 weeks to 400 and 700 ppm. Even 3 days at 1500 ppm (14h/d) or at 2000 ppm (8h/d) were sufficient to induce hearing loss. Nylen et al. (1987) demonstrated that the ototoxicity of toluene is governed by intensity of exposure and not by duration or cumulative exposure. Impairment of auditory function as determined electrophysiologically was found in male Sprague Dawley rats after exposure to 1000 ppm (22h/d, 7d/week) over 1 month corresponding to 0.62 million ppm x h. On the other hand, no effects were found after a cumulative exposure of 2.46 million ppm x h achieved by a shorter weekly exposure regime to 1000 ppm (6h/d, 5d/week) over 19 month.   Direct evidence that maximal hearing impairment will already be reached after a few weeks of exposure is also obtained by the data of Gagnaire et al. (2007) with ethylbenzene itself. Hearing deficits recorded electrophysiologically 4, 8, and 13 weeks after start of exposure (6h/d, 6d/week) and after additional 8 weeks of exposure free observation were all essentially the same: there was no increase of hearing loss over time and the NOAEC of 200 ppm did not change. The same applied for the two different mixed xylenes tested, containing either 10% or 20% of ethylbenzene.   In summary, an exacerbation of hearing deficits is not to be expected by prolongation of exposure beyond a few weeks or from 13 weeks to life time.   2. Sensitivity of histopathological and (electro)physiological effects   In the overall assessment it has also be taken into consideration that the NOAEC for ototoxicity as defined by auditory dysfunction is clearly higher than that defined by histopathological effects on the outer hair cells of the cochlea. Numerous investigations have shown that audiometric hearing deficits occur at higher exposure concentrations than (small) losses of hair cells in the outer row 3 of the cochlea. This was described by Gagnaire et al. (2007) for ethylbenzene and two different mixed xylenes. The NOAECs/LOAECs were found at the following concentration: ethylbenzene: auditory threshold - NOAEC 200 ppm; histopathology - LOAEC 200 ppm; mixed xylene (1): auditory threshold - NOAEC 500 ppm; histopathology - LOAEC 250 ppm; mixed xylene (2): auditory threshold - NOAEC 1000 ppm; histopathology - NOAEC 500 ppm.   Similar findings were reported for styrene by Loquet et al.(1999), Lataye et al. (2005), Pouyatos et al. (2002), or Lataye et al.(2001).In this respect the findings of Lataye et al. (2001) are important. After exposure to styrene at 1000 and 1500 ppm there was a clear cell loss in the medium spiral ganglion, but not at 750 ppm corresponding better to the dose response relationship of hearing loss (by electrophysiology) than the outer hair cell loss in the cochlea. Thus, the functional results are in better agreement with the morphological results at the level of the spiral ganglion than with those obtained at the level of the cochlea.   The inconsistency in the dose response relationship of the degenerative process of hair cells along the cochlea on the one hand with electrophysiologically measured changes of the auditory threshold on the other hand can be explained by the anatomical situation. To begin with, the auditory message comes mainly from the inner hair cells which are much less prone to damage by organic solvents than the outer hair cells, especially those in row 3. Secondly, the functional results of hearing loss are in better agreement with histopathological changes in the spiral ganglion rather than with those at the level of the cochlea. In this respect Lataye et al. (2001) point to an investigation of Prosen et al. (1990) who showed that a massive loss of outer hair cells (up to 50% in the 30% apical region of the cochlea) did not cause hearing loss at any frequency. They conclude that the functional role played by the apical outer hair cells appears to be secondary in the rat. Furthermore after oral exposure of rats to styrene Chen et al. (2008) found that a loss of outer hair cells of <33% did not result in a significant shift of hearing threshold.   Thus, taking very small losses of outer hair cells in row 3 as the decisive endpoint is a very conservative approach for risk assessment based upon hearing impairment.   3. Anatomical/histological differences of target tissues between rats and humans.   The mechanism was clarified for styrene by Campo P. (1999), Loquet et al. (1999), and Campo P. et al. (2001): Styrene, transported by blood coming from the stria vascularis or the spiral prominence, diffuses through the outer sulcus to reach the lipid-rich Hensen’s cells. These cells are in close connection with the Deiters cells that are directly located under the outer hair cells. Thus, the target cells are reached by diffusion of styrene. This explains why hair cells are lost in a sequence from the outer row 3 to row 1 as diffusion continuous and why the inner hair cell are the least sensitive. Specifically, the involvement of Hensen’s and Deiters cells was supported by histopathology of semi-thick sections of the cochlea (Campo et al., 2001) and Chen et al. (2007) demonstrated that Deiters cells are an especially vulnerable target of styrene. The latter authors further reported that the styrene concentrations in the cochlea varied along with the basilar membrane with the lowest level in the basal turn being consistent with the lowest styrene induced threshold shift and hair cell loss in this region.   The mode of action for hearing loss induced by styrene is well-defined and the weight of evidence indicates that it also applies to other aromatic solvents including ethylbenzene. As shown above ototoxicity is governed by direct impact of the (unmetabolised) parent compound on the hair cells of the cochlea. Passage to these target cells occurs via diffusion of the solvent from blood through Hensen’s and Deiters cells. Taking into account the identical target cells (outer hair cells, Hensen’s cells, Deiters cells) and the identical structure of the target organ (cochlea) and even its blood supply, the toxicodynamics for ototoxicity caused by aromatic solvents are very similar between species. This also applies to the comparison between humans and rats if as a conservative assumption humans are considered to be of comparable sensitivity as rats.   The following information is taken into account for any hazard/risk assessment:   The repeated exposure toxicity of ethylbenzene has been evaluated in animals in subchronic and chronic inhalation studies, subchronic oral toxicity studies and numerous specialized investigations. Overall, ethylbenzene poses a moderate repeated exposure toxicity hazard with consistent targeted effects to the liver, kidney and hearing.   Repeated dose toxicity (Oral): Changes in hematology, indicative of a mild regenerative anemia, and clinical chemistry parameters, indicative of hepatic microsomal enzyme induction, decreases in prothrombin time, mild alimentary effects and kidney (males only) and liver pathology were observed in rats that received gavage doses of > 250 mg/kg bwt/day ethylbenzene for 90 days. Repeated dose toxicity (Dermal): No data Repeated dose toxicity (Inhalation): 90 day inhalation study in rats concluded ototoxic effects at> 200 ppm. The study NOAEC was calculated to be 114 ppm (500 mg/m3). Value used for CSA (via oral route - systemic effects): (NOAEL: 75 mg/kg bw/day) Value used for CSA (inhalation- systemic effects): (NOAEC: 500 mg/m³)   Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint:Changes in hematology, indicative of a mild regenerative anemia, and clinical chemistry parameters, indicative of hepatic microsomal enzyme induction, decreases in prothrombin time, mild alimentary effects and kidney (males only) and liver pathology were observed in rats that received gavage doses of > 250 mg/kg bwt/day ethylbenzene for 90 days.Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint:90 day inhalation study in rats concluded ototoxic effects at > 200 ppm. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4c88c6e-06c7-4daa-b0fb-1a55459ac22f/documents/IUC5-82402b09-8d8f-495c-b673-95b205be60e0_8ed375af-eef5-45ed-9467-62cc5de8dc08.html,,,,,, Ethylbenzene,100-41-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4c88c6e-06c7-4daa-b0fb-1a55459ac22f/documents/IUC5-82402b09-8d8f-495c-b673-95b205be60e0_8ed375af-eef5-45ed-9467-62cc5de8dc08.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,500 mg/m3,, Ethylbenzene,100-41-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4c88c6e-06c7-4daa-b0fb-1a55459ac22f/documents/IUC5-82402b09-8d8f-495c-b673-95b205be60e0_8ed375af-eef5-45ed-9467-62cc5de8dc08.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat Ethylbenzene,100-41-4,"Human data on the acute toxicity of ethylbenzene are not available and studies have been limited to assessments of odor and irritation/sensory irritation. In animals ethylbenzene proved to be harmful by inhalation of the vapours (the inhalation LC50 for rats is 4000 ppm or 17.6 mg/l/4 hours) (Union Carbide, 1949). Oral and dermal toxicity is low with LD50 values above 2000 mg/kg: an oral LD50 of 3500 mg/kg was determined for rats in general (Wolf et al., 1956), and an oral LD50 of 5460 mg/kg specifically for male rats (Smyth et al., 1962); the acute dermal toxicity was tested with rabbits and revealed a dermal LD50 of 15.4 g/kg (Union Carbide, 1949).  Gerarde (1960) hypothesized that pulmonary injury resulting in chemical pneumonitis might be the principal cause of the deaths observed after oral administration of ethylbenzene to rats because necropsy after oral administration revealed hyperaemia and haemorrhage of the lungs. As a result of his experiments he concluded that aspiration of even a small amount of ethylbenzene may cause severe lung injury. And due to its low viscosity and surface tension ethylbenzene would spread over a large area of pulmonary tissue, causing oedema and haemorrhage. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4c88c6e-06c7-4daa-b0fb-1a55459ac22f/documents/IUC5-6aa1d892-636c-4a3e-a3fa-cce4eed5dbc9_8ed375af-eef5-45ed-9467-62cc5de8dc08.html,,,,,, Ethylbenzene,100-41-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4c88c6e-06c7-4daa-b0fb-1a55459ac22f/documents/IUC5-6aa1d892-636c-4a3e-a3fa-cce4eed5dbc9_8ed375af-eef5-45ed-9467-62cc5de8dc08.html,,oral,LD50,"3,500 mg/kg bw",no adverse effect observed, Ethylbenzene,100-41-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4c88c6e-06c7-4daa-b0fb-1a55459ac22f/documents/IUC5-6aa1d892-636c-4a3e-a3fa-cce4eed5dbc9_8ed375af-eef5-45ed-9467-62cc5de8dc08.html,,dermal,LD50,"15,400 mg/kg bw",no adverse effect observed, Ethylbenzene,100-41-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4c88c6e-06c7-4daa-b0fb-1a55459ac22f/documents/IUC5-6aa1d892-636c-4a3e-a3fa-cce4eed5dbc9_8ed375af-eef5-45ed-9467-62cc5de8dc08.html,,inhalation,LC50,"17,629 mg/m3",no adverse effect observed, "Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine",100545-48-0," The substance was evaluated in three repeated-dose toxicity studies performed by the oral and inhalation routes. By the oral route, rats treated for 14 days showed no remarkable effects up to a dose-level of 1000 mg/kg bw/day. By inhalation, no systemic effects were observed in rats exposed up to 2020 mg/m3 air for 14 days or up to 103.4 mg/m3 air for 90 days while local respiratory effects were noted. Histopathological evaluation performed in the subchronic study revealed local pulmonary effects. The cellular changes in the bronchoalveolar lavage (BAL) and haematology  were consistent with the microscopic findings and confirmed the local pulmonary toxicity of the test substance. Based on these findings, the NOAEC was set to 3.06 mg/m3. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbb0ec11-4454-4977-b7e7-30ae0821fb42/documents/IUC5-0967e399-c305-47b0-bc65-82fb7e0fd96f_75f09dec-c4a7-4e0b-a448-c9fb32a9f158.html,,,,,, "Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine",100545-48-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbb0ec11-4454-4977-b7e7-30ae0821fb42/documents/IUC5-0967e399-c305-47b0-bc65-82fb7e0fd96f_75f09dec-c4a7-4e0b-a448-c9fb32a9f158.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine",100545-48-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbb0ec11-4454-4977-b7e7-30ae0821fb42/documents/IUC5-0967e399-c305-47b0-bc65-82fb7e0fd96f_75f09dec-c4a7-4e0b-a448-c9fb32a9f158.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,103.4 mg/m3,,rat "Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine",100545-48-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbb0ec11-4454-4977-b7e7-30ae0821fb42/documents/IUC5-0967e399-c305-47b0-bc65-82fb7e0fd96f_75f09dec-c4a7-4e0b-a448-c9fb32a9f158.html,Repeated dose toxicity – local effects,inhalation,NOAEC,3.06 mg/m3,adverse effect observed,rat "Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine",100545-48-0,The acute oral and inhalation toxicity studies indicate that the substance is of low toxicity if swallowed (rat LD0 > or = 2000 mg/kg bw) or inhaled (rat LC0 > or = 5050 mg/m3).No information regarding the acute dermal toxicity of the test substance is available. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbb0ec11-4454-4977-b7e7-30ae0821fb42/documents/IUC5-4d6c0da4-39c4-4515-9c6a-335c32bab562_75f09dec-c4a7-4e0b-a448-c9fb32a9f158.html,,,,,, "Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine",100545-48-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbb0ec11-4454-4977-b7e7-30ae0821fb42/documents/IUC5-4d6c0da4-39c4-4515-9c6a-335c32bab562_75f09dec-c4a7-4e0b-a448-c9fb32a9f158.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Octadecanoic acid, 12-hydroxy-, reaction products with ethylenediamine",100545-48-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbb0ec11-4454-4977-b7e7-30ae0821fb42/documents/IUC5-4d6c0da4-39c4-4515-9c6a-335c32bab562_75f09dec-c4a7-4e0b-a448-c9fb32a9f158.html,,inhalation,LC50,"5,050 mg/m3",no adverse effect observed, "1,4-dioxacycloheptadecane-5,17-dione",105-95-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The key study is GLP-compliant and of high quality (Klimisch score = 2) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a877e930-db59-484d-811f-583e7dd5c6b3/documents/IUC5-9f838a9e-745f-454d-8b6e-d1f7990b9212_89eb1fac-9414-4be1-bed1-35812447eaa5.html,,,,,, "1,4-dioxacycloheptadecane-5,17-dione",105-95-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a877e930-db59-484d-811f-583e7dd5c6b3/documents/IUC5-9f838a9e-745f-454d-8b6e-d1f7990b9212_89eb1fac-9414-4be1-bed1-35812447eaa5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,4-dioxacycloheptadecane-5,17-dione",105-95-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Only basic data given. However, only one death and slight lethargy were observed at the dose level of 5000 mg/kg bw, which is 2.5 times more than the limit dose of the OECD 401/423/425. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover this endpoint. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Only basic data given. However, the result was non-toxic at the dose level of 5000 mg/kg bw, which is 2.5 times more than the limit dose of the OECD 402. A repeat study is unlikely to show worse effects, therefore this study was considered sufficiently robust to cover this endpoint. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a877e930-db59-484d-811f-583e7dd5c6b3/documents/IUC5-1cf3cdd8-cc96-4701-97a5-0bef0afba2ab_89eb1fac-9414-4be1-bed1-35812447eaa5.html,,,,,, "1,4-dioxacycloheptadecane-5,17-dione",105-95-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a877e930-db59-484d-811f-583e7dd5c6b3/documents/IUC5-1cf3cdd8-cc96-4701-97a5-0bef0afba2ab_89eb1fac-9414-4be1-bed1-35812447eaa5.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "1,4-dioxacycloheptadecane-5,17-dione",105-95-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a877e930-db59-484d-811f-583e7dd5c6b3/documents/IUC5-1cf3cdd8-cc96-4701-97a5-0bef0afba2ab_89eb1fac-9414-4be1-bed1-35812447eaa5.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Ethylene carbonate,96-49-1," Repeated dose toxicity: oral: No reliable data are available on repeated dose toxicity via the oral route for ethylene carbonate. Data with the read-across substance ethylene glycol, an ethylene carbinate metabolite, were used in a weight of evidence approach to cover the endpoint information requirements. Three reliable repeated dose toxicity studies are available for the oral route. A chronic NOAEL of 150 mg/kg bw/day (actual ingested) was observed in male Wistar rats after 12 months of daily exposure to ethylene glycol. The study was performed according to a guideline equivalent to OECD Guideline 452. In a 10 -day and 90 -day repeated dose toxicity study with ethylene glycol in male and female Sprague-Dawley rats a NOAEL of 1108 mg/kg bw/day (males)/2216 mg/kg/day (females), and a NOAEL of 554 mg/kg bw/day (males)/LOAEL of 554 mg/kg bw/day (females) were determined respectively. Repeated dose toxicity: dermal and inhalation: No reliable data are available on repeated dose toxicity via the dermal and inhalation route. Reliable chronic toxicity data (12 months exposure) are available from a study with ethylene glycol via the oral route. According to the REACH Regulation, a short-term and sub-chronic repeated dose toxicity test does not need to be conducted if a reliable chronic study is available, provided that an appropriate species and route of administration were used (Column 2 adaptation, Annexes VIII and IX respectively). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a5e8d4a-128b-4d2e-8ef7-b2df4c9f2eb0/documents/IUC5-53420908-9358-47d8-ada0-10b767d282f3_574d72e9-808d-453a-b27c-cd4330ffdced.html,,,,,, Ethylene carbonate,96-49-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a5e8d4a-128b-4d2e-8ef7-b2df4c9f2eb0/documents/IUC5-53420908-9358-47d8-ada0-10b767d282f3_574d72e9-808d-453a-b27c-cd4330ffdced.html,Chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Ethylene carbonate,96-49-1,"The LD50/LC50 values from the key-studies were: LD50 (oral, rat) 10400 mg/kg bw, LD50 (dermal, rat) > 2000 mg/kg bw, LC50 (inhalation, rat) > 730 mg/m3 air. The studies were performed respectively according to OECD guidelines 401, 402 and 403. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a5e8d4a-128b-4d2e-8ef7-b2df4c9f2eb0/documents/IUC5-0e9498f1-d908-41a5-b69f-a8f79567fdd2_574d72e9-808d-453a-b27c-cd4330ffdced.html,,,,,, Ethylene carbonate,96-49-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a5e8d4a-128b-4d2e-8ef7-b2df4c9f2eb0/documents/IUC5-0e9498f1-d908-41a5-b69f-a8f79567fdd2_574d72e9-808d-453a-b27c-cd4330ffdced.html,,oral,LD50,"10,400 mg/kg bw",no adverse effect observed, Ethylene carbonate,96-49-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a5e8d4a-128b-4d2e-8ef7-b2df4c9f2eb0/documents/IUC5-0e9498f1-d908-41a5-b69f-a8f79567fdd2_574d72e9-808d-453a-b27c-cd4330ffdced.html,,inhalation,LC50,730 mg/m3,no adverse effect observed, "1,2-dichloroethane",107-06-2," The toxicity of 1,2-dichloroethane was investigated in several oral studies in rats and mice for 90 days (Daniel et al., 1994), 2 years (Alumot et al., 1976) and 13 weeks (Morgan et al., 1990; NTP, 1991; Munson et al., 1982) and inhalation studies in rats and mice (Heppel et al., 1946; Spencer et al., 1951; Hofmann et al., 1971; Maltoni et al., 1980/Spreafico et al., 1980) and in guinea pigs, rabbits, cats, dogs, and monkeys (Heppel et al., 1946; Spencer et al., 1951), resulting in overall NOAELs or NOAECs of 37.5 mg/kg bw/d for the oral route and 41.1 mg/m³ for the inhalation route. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa282933-1026-44ed-bf54-f2748cb4698e/documents/IUC5-2e1ffd80-907f-4123-924c-0b8af9895c03_4c2c4cf4-c033-4438-815e-342c9552a1d2.html,,,,,, "1,2-dichloroethane",107-06-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa282933-1026-44ed-bf54-f2748cb4698e/documents/IUC5-2e1ffd80-907f-4123-924c-0b8af9895c03_4c2c4cf4-c033-4438-815e-342c9552a1d2.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,41.1 mg/m3,, "1,2-dichloroethane",107-06-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa282933-1026-44ed-bf54-f2748cb4698e/documents/IUC5-2e1ffd80-907f-4123-924c-0b8af9895c03_4c2c4cf4-c033-4438-815e-342c9552a1d2.html,Chronic toxicity – systemic effects,oral,NOAEL,37.5 mg/kg bw/day,,"other:several species: rats, mice, rabbits, dogs, monkeys" "1,2-dichloroethane",107-06-2," Oral route: None of the studies described fulfilled completely the requirements from internationally accepted guidelines or were documented with deficiencies. Thus, in a weight of evidence approach from out of 5 studies with conclusive results the lowest LD50 of 413 mg/kg bw  determined in mice (Munson, 1982) was chosen for classification/labelling and risk assessment. Inhalation route: For inhalation toxicity, a 4-h LC50 of 1886 ppm (approx. 7758 mg/m³)  in albino rats was derived from a dose-response graph (Spencer, 1951). Additional information, Hotchkiss study (2010), clearly suggest that the 4-h LC50 is higher that 2000 ppm (approx. 10000 mg/ m³). A new study was conducted to determine the acute inhalation toxicological properties of 1,2-dichloroethane (EDC) vapors by Hotchkiss et al (2017). Groups of five rats/sex were exposed for four hours, using a whole-body inhalation exposure system, to a mean chamber concentration of 2520 ppm EDC vapor (10.2 mg EDC/L air). Based on the data generated in this study, the 4-hour LC50of inhaled 1,2-dichloroethane vapors is > 2520 ppm (10.2 mg/L) for male and < 2520 ppm (10.2 mg/L) for female F344/DuCrl rats. Previous studies reported no mortality in any male and female F344/DuCrl rats whole-body exposed for 4 hours to vapor concentrations of 196, 678, 1904, or 2029 ppm 1,2-dichloroethane. Taking into account all of these data, calculated LC50values of > 2520 ppm (10.2 mg/L) for male and 2273 ppm (9.2 mg/L) for female F344/DuCrl rats were determined and the combined LC50for both sexes was 2404 ppm (9.7 mg/L). Dermal route: The dermal route was waived since more reliable data were available for exposure routes with higher relevance, i.e. oral and inhalation route. However, the mean LD50-value for acute dermal toxicity after application of 1,2-dichloroethane under occluded conditions to rabbits was 4890 mg/kg bw with a 95 % confidence interval of 4270–5600 mg/kg bw based on a study by Mellon Inst. Industr. Research (1948). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa282933-1026-44ed-bf54-f2748cb4698e/documents/IUC5-c0df8001-475b-4130-a80e-d1d94f4261f3_4c2c4cf4-c033-4438-815e-342c9552a1d2.html,,,,,, "1,2-dichloroethane",107-06-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa282933-1026-44ed-bf54-f2748cb4698e/documents/IUC5-c0df8001-475b-4130-a80e-d1d94f4261f3_4c2c4cf4-c033-4438-815e-342c9552a1d2.html,,oral,LD50,413 mg/kg bw,adverse effect observed, "1,2-dichloroethane",107-06-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa282933-1026-44ed-bf54-f2748cb4698e/documents/IUC5-c0df8001-475b-4130-a80e-d1d94f4261f3_4c2c4cf4-c033-4438-815e-342c9552a1d2.html,,dermal,LD50,"4,890 mg/kg bw",no adverse effect observed, "1,2-dichloroethane",107-06-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa282933-1026-44ed-bf54-f2748cb4698e/documents/IUC5-c0df8001-475b-4130-a80e-d1d94f4261f3_4c2c4cf4-c033-4438-815e-342c9552a1d2.html,,inhalation,LC50,"7,758 mg/m3",adverse effect observed, "N,N'-ethane-1,2-diylbisoleamide",110-31-6,"NOAEL (subchronic, oral, rat): 731.8 (m) and 834.5 (f) mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee7d04fe-a02b-4517-aec9-78e8b5bb0b61/documents/40210131-6aa9-4f84-b0c7-21633e150e36_9f904019-1acd-4b2b-9d3f-a552ca706fc7.html,,,,,, "N,N'-ethane-1,2-diylbisoleamide",110-31-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee7d04fe-a02b-4517-aec9-78e8b5bb0b61/documents/40210131-6aa9-4f84-b0c7-21633e150e36_9f904019-1acd-4b2b-9d3f-a552ca706fc7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,731.8 mg/kg bw/day,,rat "N,N'-ethane-1,2-diylbisoleamide",110-31-6,"Oral (OECD 401), rat: LD50 > 5000 mg/kg bw (limit test), based on read-across from Amides, C16-C18 (even), N,N'-ethylenebisInhalation (OECD 403), rat, 4 h exposure: LC50 > 6.3 mg/L (limit test), based on read-across from Amides, C16-C18 (even), N,N'-ethylenebisDermal (OECD 402), rabbit: LD50 > 2000 mg/kg bw (limit test), based on read-across from Amides, C16-C18 (even), N,N'-ethylenebis ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee7d04fe-a02b-4517-aec9-78e8b5bb0b61/documents/43b944e4-48a8-4c8c-87d2-32303075d4ef_9f904019-1acd-4b2b-9d3f-a552ca706fc7.html,,,,,, "N,N'-ethane-1,2-diylbisoleamide",110-31-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee7d04fe-a02b-4517-aec9-78e8b5bb0b61/documents/43b944e4-48a8-4c8c-87d2-32303075d4ef_9f904019-1acd-4b2b-9d3f-a552ca706fc7.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "N,N'-ethane-1,2-diylbisoleamide",110-31-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee7d04fe-a02b-4517-aec9-78e8b5bb0b61/documents/43b944e4-48a8-4c8c-87d2-32303075d4ef_9f904019-1acd-4b2b-9d3f-a552ca706fc7.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "N,N'-ethane-1,2-diylbisoleamide",110-31-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee7d04fe-a02b-4517-aec9-78e8b5bb0b61/documents/43b944e4-48a8-4c8c-87d2-32303075d4ef_9f904019-1acd-4b2b-9d3f-a552ca706fc7.html,,inhalation,LC50,"> 6,300 mg/m3",no adverse effect observed, "1,4-dioxacyclohexadecane-5,16-dione",54982-83-1," Key information for the parent compound Zenolide did not show systemic toxic effects in an oral gavage OECD TG 407 study (GLP) with Sprague Dawley rats in which a NOAEL ≥1000 mg/kg bw/day was derived. Zenolide did show systemic toxic effects in an oral OECD 421 study (GLP) with Wistar rats in which a NOAEL of 300 and 1000 mg/kg bw/day was derived for male and female rats, respectively. Zenolide is expected to have a NOAEL of 300 mg/kg bw in a chronic study because its toxicity can be based on its key metabolite Ethylene glycol. Key information for the metabolites Ethylene glycol did show systemic toxic effects in an oral 90 -day toxicity study in mice (Similar to OECD 408, GLP) in which NOAELs of 3000 and 12000 mg/kg bw/day were derived for male and female mice, respectively. Literature data revealed that Ethylene glycol did show systemic toxic effects in an oral 90 -day toxicity study in Wistar rats in which a NOAEL of 150 mg/kg bw/day was derived. In another study with F344 rats, the NOAEL was ca. 3 times higher. The 90-day NOAEL can be extrapolated to a chronic value because NOAELs for EG were the same independent from the repeated dose toxicity duration. Information from the ECHA website showed that Dodecanedioic acid did not show toxic effect in an OECD TG 422 and in an OECD TG 408 study. In both tests, a NOAEL of ≥1000 mg/kg bw was derived. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4233f9d3-3bbe-4c5d-879b-eae4a58f29ad/documents/IUC5-a7824057-d1e5-4387-823b-bc351404a9a7_a265cdb3-458f-4ead-b719-10cd452ab0bc.html,,,,,, "1,4-dioxacyclohexadecane-5,16-dione",54982-83-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4233f9d3-3bbe-4c5d-879b-eae4a58f29ad/documents/IUC5-a7824057-d1e5-4387-823b-bc351404a9a7_a265cdb3-458f-4ead-b719-10cd452ab0bc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "1,4-dioxacyclohexadecane-5,16-dione",54982-83-1, Acute oral toxicity: OECD TG 401: LD50: 4500 mg/kg bw Acute inhalation toxicity: Extrapolated from acute oral toxicity LC50: 23400 mg/m3 Acute dermal toxicity: Using route to route extrapolation LD50: >2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4233f9d3-3bbe-4c5d-879b-eae4a58f29ad/documents/IUC5-20c3115b-5a6c-432e-9129-1ad4e9e54d45_a265cdb3-458f-4ead-b719-10cd452ab0bc.html,,,,,, Ethylenediamine,107-15-3," In repeated dose studies, decreased body weights and water and feed consumption have been observed, and are probably related to the irritating nature of EDA and its high pH. Hepatocellular pleomorphism has been observed and also increased ASAT and ALAS values. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b2613f9-21bd-46e9-b9a9-09e4bd9ea92d/documents/74574028-40c1-4515-8a33-7316c45d5260_e4d8849e-7e93-45aa-ba23-da27f4586391.html,,,,,, Ethylenediamine,107-15-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b2613f9-21bd-46e9-b9a9-09e4bd9ea92d/documents/74574028-40c1-4515-8a33-7316c45d5260_e4d8849e-7e93-45aa-ba23-da27f4586391.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,327 mg/m3,,rat Ethylenediamine,107-15-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b2613f9-21bd-46e9-b9a9-09e4bd9ea92d/documents/74574028-40c1-4515-8a33-7316c45d5260_e4d8849e-7e93-45aa-ba23-da27f4586391.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,22 mg/kg bw/day,,rat Ethylenediamine,107-15-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b2613f9-21bd-46e9-b9a9-09e4bd9ea92d/documents/74574028-40c1-4515-8a33-7316c45d5260_e4d8849e-7e93-45aa-ba23-da27f4586391.html,Chronic toxicity – systemic effects,dermal,NOAEL,8.3 mg/kg bw/day,,mouse Ethylenediamine,107-15-3, LD50/LC50 (4 -h) values are based on animal test data for acute toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b2613f9-21bd-46e9-b9a9-09e4bd9ea92d/documents/bf04458d-51d0-4f65-a2c9-5c867cd09ef0_e4d8849e-7e93-45aa-ba23-da27f4586391.html,,,,,, Ethylenediamine,107-15-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b2613f9-21bd-46e9-b9a9-09e4bd9ea92d/documents/bf04458d-51d0-4f65-a2c9-5c867cd09ef0_e4d8849e-7e93-45aa-ba23-da27f4586391.html,,oral,LD50,866 mg/kg bw,adverse effect observed, Ethylenediamine,107-15-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b2613f9-21bd-46e9-b9a9-09e4bd9ea92d/documents/bf04458d-51d0-4f65-a2c9-5c867cd09ef0_e4d8849e-7e93-45aa-ba23-da27f4586391.html,,dermal,LD50,560 mg/kg bw,adverse effect observed, Ethylenediamine,107-15-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b2613f9-21bd-46e9-b9a9-09e4bd9ea92d/documents/bf04458d-51d0-4f65-a2c9-5c867cd09ef0_e4d8849e-7e93-45aa-ba23-da27f4586391.html,,inhalation,,"14,700 mg/m3",adverse effect observed, 2-ethylhexanal,123-05-7,Repeated dose toxicity: oral: no valid data availabledermal: no data availableinhalation: NOAEC: 0.54 mg/L air for systemic toxicity; NOEC: 0.14 mg/L air for peroxisome proliferation ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/42ef022e-de90-4fd1-a37d-a6e838bd464f/documents/IUC5-dcebe3f3-0897-49ac-aed5-02d7ebc4ab1f_6eeed409-402d-4ee1-9e62-612ee094d499.html,,,,,, 2-ethylhexanal,123-05-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/42ef022e-de90-4fd1-a37d-a6e838bd464f/documents/IUC5-dcebe3f3-0897-49ac-aed5-02d7ebc4ab1f_6eeed409-402d-4ee1-9e62-612ee094d499.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,540 mg/m3,, 2-ethylhexanal,123-05-7,"2 Ethylhexanal is of low toxicity after a single ingestion, and virtually nontoxic after skin contact or inhalation exposure:- oral: LD50: 2600 mg/kg bw (rat);- inhalation: > 6.83 mg/L air (OECD 403);- dermal: >16440 mg/kg bw (rat) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42ef022e-de90-4fd1-a37d-a6e838bd464f/documents/IUC5-f9ae5a92-306f-4b52-8c8b-85910269f606_6eeed409-402d-4ee1-9e62-612ee094d499.html,,,,,, 2-ethylhexanal,123-05-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42ef022e-de90-4fd1-a37d-a6e838bd464f/documents/IUC5-f9ae5a92-306f-4b52-8c8b-85910269f606_6eeed409-402d-4ee1-9e62-612ee094d499.html,,oral,LD50,"2,600 mg/kg bw",, 2-ethylhexanal,123-05-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42ef022e-de90-4fd1-a37d-a6e838bd464f/documents/IUC5-f9ae5a92-306f-4b52-8c8b-85910269f606_6eeed409-402d-4ee1-9e62-612ee094d499.html,,dermal,LD50,"16,640 mg/kg bw",, 2-ethylhexanal,123-05-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42ef022e-de90-4fd1-a37d-a6e838bd464f/documents/IUC5-f9ae5a92-306f-4b52-8c8b-85910269f606_6eeed409-402d-4ee1-9e62-612ee094d499.html,,inhalation,LC50,"6,830 mg/m3",, 2-ethylhexyl 12-(acetoxy)octadecanoate,61800-40-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d82a83fb-2dd7-4b0c-bba1-482465c40570/documents/a1f970fd-730f-4804-a60c-0464d8a3c89c_cd9c303c-44ed-4bf7-890d-e87598104efc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-ethylhexyl 12-(acetoxy)octadecanoate,61800-40-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d82a83fb-2dd7-4b0c-bba1-482465c40570/documents/70cd1cec-7b45-4f3f-869f-737961e89855_cd9c303c-44ed-4bf7-890d-e87598104efc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-ethylhexyl 12-(acetoxy)octadecanoate,61800-40-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d82a83fb-2dd7-4b0c-bba1-482465c40570/documents/70cd1cec-7b45-4f3f-869f-737961e89855_cd9c303c-44ed-4bf7-890d-e87598104efc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-ethylhexyl 12-(acetoxy)octadecanoate,61800-40-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d82a83fb-2dd7-4b0c-bba1-482465c40570/documents/70cd1cec-7b45-4f3f-869f-737961e89855_cd9c303c-44ed-4bf7-890d-e87598104efc.html,,inhalation,LC50,5.07 mg/m3,no adverse effect observed, 2-ethylhexyl 4-(dimethylamino)benzoate,21245-02-3,"A 28-day repeated toxicity study is available on 2-ethylhexyl 4-(dimethylamino)benzoate. Target organs appeared to include testis/epididymis, spleen and the liver. The NOAEL under the conditions in this study was 300 mg/kg/day based on histopathological observations in the testis/epididymis at 1000 mg/kg/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study was performed in equivalence with a standardised guideline under GLP conditions. The study was assigned a reliability score of 1 in line with the principles for assessing data quality as defined by Klimisch et al. (1997). Therefore, the quality of the database is considered to be good. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fbd4559-e1f7-4623-a8d9-a8c05afbc71a/documents/072d4f2d-ab91-44a7-ada4-998eaa8aeef5_2154db34-3a07-4dbc-8065-49ccdadb562a.html,,,,,, 2-ethylhexyl 4-(dimethylamino)benzoate,21245-02-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fbd4559-e1f7-4623-a8d9-a8c05afbc71a/documents/072d4f2d-ab91-44a7-ada4-998eaa8aeef5_2154db34-3a07-4dbc-8065-49ccdadb562a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 2-ethylhexyl 4-(dimethylamino)benzoate,21245-02-3,"Based on the available data, the oral LD50 value for the test material (50 % in corn oil) was 14900 mg/kg in both male and female rats. No acute toxicity study is available by dermal route or by inhalation. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Two studies are available to address this endpoint, one key and one supporting. The studies were conducted prior to the inception of GLP though are considered to be adequate for risk assessment purposes. The key information is included in the reports. The quality of the database is therefore considered to be good. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fbd4559-e1f7-4623-a8d9-a8c05afbc71a/documents/ff6d4f20-2b71-48d8-b18d-7e94a5a722d6_2154db34-3a07-4dbc-8065-49ccdadb562a.html,,,,,, 2-ethylhexyl 4-(dimethylamino)benzoate,21245-02-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fbd4559-e1f7-4623-a8d9-a8c05afbc71a/documents/ff6d4f20-2b71-48d8-b18d-7e94a5a722d6_2154db34-3a07-4dbc-8065-49ccdadb562a.html,,oral,LD50,"14,900 mg/kg bw",no adverse effect observed, 2-ethylhexyl 12-hydroxyoctadecanoate,29710-25-6," LD50 (rat, oral route) > 2000 mg/kg LC50 (rat, inhalation route) > 9.7 mg/L LD50 (rat. dermal route) > 2000 mg/kg ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/caebb2c7-9f7e-4cb1-bca7-5d4ee5eb3233/documents/07b64001-3074-40aa-99a2-ef5635bbd2b4_8c6a6372-a197-4542-b43e-30846ff6c14f.html,,,,,, 2-ethylhexyl 12-hydroxyoctadecanoate,29710-25-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/caebb2c7-9f7e-4cb1-bca7-5d4ee5eb3233/documents/07b64001-3074-40aa-99a2-ef5635bbd2b4_8c6a6372-a197-4542-b43e-30846ff6c14f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-ethylhexyl 12-hydroxyoctadecanoate,29710-25-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/caebb2c7-9f7e-4cb1-bca7-5d4ee5eb3233/documents/07b64001-3074-40aa-99a2-ef5635bbd2b4_8c6a6372-a197-4542-b43e-30846ff6c14f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-ethylhexyl laurate,20292-08-4,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/838070d9-91f2-4acb-904c-b5182ed68f45/documents/IUC5-2be39757-41f7-4a49-b03d-300254e7bacb_6989f2df-3d56-4bb9-b94c-a0d0c9bbd9f8.html,,,,,, 2-ethylhexyl laurate,20292-08-4,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/838070d9-91f2-4acb-904c-b5182ed68f45/documents/IUC5-b7765b29-fc70-4101-8017-28197aa32203_6989f2df-3d56-4bb9-b94c-a0d0c9bbd9f8.html,,,,,, 2-ethylhexyl methacrylate,688-84-6," In an oral OECD 408 study performed according GLP, the no observed adverse effect level (NOAEL) was 120 mg/kg body weight/day in male and female Wistar rats (BASF, 2009). Data on the primary metabolites methacrylic acid and 2-ethylhexanol do not reveal critical effects like specific target organ toxicity. Toxicity of 2-ethylhexanol is lower than the parent ester toxicity based on NOAELs. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c06b7cf6-8d91-4ce9-bb5f-ac7c0b8d0984/documents/bb6274bd-1caf-4e31-85f5-93452882bf40_06e65574-677f-45fe-b349-81453231be15.html,,,,,, 2-ethylhexyl methacrylate,688-84-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c06b7cf6-8d91-4ce9-bb5f-ac7c0b8d0984/documents/bb6274bd-1caf-4e31-85f5-93452882bf40_06e65574-677f-45fe-b349-81453231be15.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat 2-ethylhexyl methacrylate,688-84-6,"2-ethylhexyl methacrylate is of low toxicity by oral route (LD0/rat >= 2000 mg/kg). No reliable data are available on 2-ethylhexyl methacrylate for the dermal and inhalation routes. However, methyl- and n-butyl methacrylate, analogue substances to 2-ethylhexyl methacrylate are of low toxicity (LD0/rabbit >= 2000 mg/kg) by the dermal routes. As well, methyl-, ethyl- and n-butyl methacrylate are also of low acute inhalation toxicity with 4-h LC50 in rats of 28.9, 55.0 and 29.0 mg/l, respectively. Due to the low vapour pressure, inhalation is not considered as a relevant route of exposure for 2-ethylhexyl methacrylate. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c06b7cf6-8d91-4ce9-bb5f-ac7c0b8d0984/documents/7f0610da-ca9e-4f82-b873-004fcdda762d_06e65574-677f-45fe-b349-81453231be15.html,,,,,, 2-ethylhexyl methacrylate,688-84-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c06b7cf6-8d91-4ce9-bb5f-ac7c0b8d0984/documents/7f0610da-ca9e-4f82-b873-004fcdda762d_06e65574-677f-45fe-b349-81453231be15.html,,oral,LD50,"16,465 mg/kg bw",, 2-ethylhexyl (2E)-3-(4-methoxyphenyl)acrylate,83834-59-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/641b4529-a00b-483d-972e-b3536156861e/documents/6202162a-ab64-45a7-b1b7-c0052c7d1808_065bef77-b168-41a5-bfdd-11f673cf14d5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,, 2-ethylhexyl (2E)-3-(4-methoxyphenyl)acrylate,83834-59-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/641b4529-a00b-483d-972e-b3536156861e/documents/6202162a-ab64-45a7-b1b7-c0052c7d1808_065bef77-b168-41a5-bfdd-11f673cf14d5.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,500 mg/kg bw/day",, 2-Ethylhexyl-2-cyano-3-(4-methoxyphenyl)-3-phenylprop-2-enoate,947753-66-4,A NOAEL value of 1000 mg/kg bw/day was obtained in an OECD 422 combined repeated dose toxicity and reproductive effects test. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e300469e-2873-4fd1-86ec-771da81d35b4/documents/IUC5-edb72978-5b11-479c-af75-5297f7525527_d109b282-a447-4c6b-aa84-58745477347f.html,,,,,, 2-Ethylhexyl-2-cyano-3-(4-methoxyphenyl)-3-phenylprop-2-enoate,947753-66-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e300469e-2873-4fd1-86ec-771da81d35b4/documents/IUC5-edb72978-5b11-479c-af75-5297f7525527_d109b282-a447-4c6b-aa84-58745477347f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-Ethylhexyl-2-cyano-3-(4-methoxyphenyl)-3-phenylprop-2-enoate,947753-66-4,"The acute oral LD50 of the surrogate material, undecenyl methoxycrylene, was >2000 mg/kg bw. The acute dermal LD50 or the surrogate material, undecenyl methoxycrylene, was > 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e300469e-2873-4fd1-86ec-771da81d35b4/documents/IUC5-ab53311a-5c65-4837-9d22-45a377be2538_d109b282-a447-4c6b-aa84-58745477347f.html,,,,,, 2-Ethylhexyl-2-cyano-3-(4-methoxyphenyl)-3-phenylprop-2-enoate,947753-66-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e300469e-2873-4fd1-86ec-771da81d35b4/documents/IUC5-ab53311a-5c65-4837-9d22-45a377be2538_d109b282-a447-4c6b-aa84-58745477347f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-Ethylhexyl-2-cyano-3-(4-methoxyphenyl)-3-phenylprop-2-enoate,947753-66-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e300469e-2873-4fd1-86ec-771da81d35b4/documents/IUC5-ab53311a-5c65-4837-9d22-45a377be2538_d109b282-a447-4c6b-aa84-58745477347f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-ethylhexyl oleate,26399-02-0,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39fc468b-56b4-4269-8d71-b46850abe390/documents/IUC5-2be39757-41f7-4a49-b03d-300254e7bacb_6f4287af-8a92-4c28-904a-9dea7ed32346.html,,,,,, 2-ethylhexyl oleate,26399-02-0,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39fc468b-56b4-4269-8d71-b46850abe390/documents/IUC5-b7765b29-fc70-4101-8017-28197aa32203_6f4287af-8a92-4c28-904a-9dea7ed32346.html,,,,,, 2-ethylhexyl palmitate,29806-73-3,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58cd97d2-13a9-402d-a428-4367c29ce610/documents/IUC5-7b506d9c-b5fe-4eb2-a5d6-28fb7f40f59a_821e5e15-e8bf-450b-8e52-5fd27ffbb478.html,,,,,, 2-ethylhexyl palmitate,29806-73-3,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58cd97d2-13a9-402d-a428-4367c29ce610/documents/IUC5-09060edd-2111-49a6-8d79-43db35c3cdfa_821e5e15-e8bf-450b-8e52-5fd27ffbb478.html,,,,,, 2-ethylhexyl nonanoate,59587-44-9,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4faac59d-c231-4477-bd8b-ad87d8b2fe18/documents/IUC5-f0504b62-39c3-4b69-90f7-2b442bf0d6ba_459a4996-9ece-46f0-946f-43aa727ee19a.html,,,,,, 2-ethylhexyl nonanoate,59587-44-9,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401, analogue approach)Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, analogue approach)Acute toxicity: Inhalation LC50 (rat, m/f): > 5.3 mg/L air (OECD 436, analogue approach) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4faac59d-c231-4477-bd8b-ad87d8b2fe18/documents/IUC5-33c2ee52-3ae6-4915-8d93-45e182920cea_459a4996-9ece-46f0-946f-43aa727ee19a.html,,,,,, 2-ethylhexyl salicylate,118-60-5,"NOAEL (oral, dog, 2 year chronic): 83 mg/kg bw/d 2-ethylhexyl salicylate adjustedNOEAC (inhalative, rat, 28d subacute): 1155 mg/m³ 2-ethylhexyl salicylate adjusted The findings of three weight of evidence studies (subchronic in rat with 2-ethylhexyl salicylate, chronic in rats and dogs with methyl salicylate as read -across substance) are supported by a subacute study according to OECD 421 which also investigated 2-ethylhexylsalicylate and two further subchronic studies with rats and dogs tested with methyl salicylate. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98f95666-550e-4007-a29f-96658d8dae90/documents/IUC5-2740c499-d926-40a5-841a-e15345c1d80f_25a119a4-1f54-488f-9fa9-08fed93ad699.html,,,,,, 2-ethylhexyl salicylate,118-60-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98f95666-550e-4007-a29f-96658d8dae90/documents/IUC5-2740c499-d926-40a5-841a-e15345c1d80f_25a119a4-1f54-488f-9fa9-08fed93ad699.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,155 mg/m3",,rat 2-ethylhexyl salicylate,118-60-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98f95666-550e-4007-a29f-96658d8dae90/documents/IUC5-2740c499-d926-40a5-841a-e15345c1d80f_25a119a4-1f54-488f-9fa9-08fed93ad699.html,Chronic toxicity – systemic effects,oral,NOAEL,83 mg/kg bw/day,,dog 2-ethylhexyl salicylate,118-60-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98f95666-550e-4007-a29f-96658d8dae90/documents/IUC5-2740c499-d926-40a5-841a-e15345c1d80f_25a119a4-1f54-488f-9fa9-08fed93ad699.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,155 mg/m3",no adverse effect observed,rat 2-ethylhexyl salicylate,118-60-5,"LD50(oral, rat): >5000 mg/kg;LD50(dermal, rat): >5000 mg/kg ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98f95666-550e-4007-a29f-96658d8dae90/documents/IUC5-abd20fbb-1443-4328-8343-16f5b70accd1_25a119a4-1f54-488f-9fa9-08fed93ad699.html,,,,,, 2-ethylhexyl salicylate,118-60-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98f95666-550e-4007-a29f-96658d8dae90/documents/IUC5-abd20fbb-1443-4328-8343-16f5b70accd1_25a119a4-1f54-488f-9fa9-08fed93ad699.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-ethylhexyl salicylate,118-60-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98f95666-550e-4007-a29f-96658d8dae90/documents/IUC5-abd20fbb-1443-4328-8343-16f5b70accd1_25a119a4-1f54-488f-9fa9-08fed93ad699.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-ethylhexyl stearate,22047-49-0,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f82046f2-6449-4952-8510-95d6fa3a3522/documents/IUC5-2be39757-41f7-4a49-b03d-300254e7bacb_acb106f3-91ee-4172-a506-2a8ccfda0e4e.html,,,,,, 2-ethylhexyl stearate,22047-49-0,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f82046f2-6449-4952-8510-95d6fa3a3522/documents/IUC5-b7765b29-fc70-4101-8017-28197aa32203_acb106f3-91ee-4172-a506-2a8ccfda0e4e.html,,,,,, "N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide",113-48-4," Chronic/Subchronic toxicity study by the oral route A one-year dietary administration study of MGK 264 was performed in dogs according to EPA OPP 83 -1 (chronic toxicity). MGK® 264 was offered in the diet to beagle dogs at constant concentrations of 65, 250, and l,000 ppm for one year. A control group received ground diet on the same regimen. During the study twice- daily observations of mortality/moribundity and overt toxicity were performed. The dogs were weighed weekly and the food consumed was measured weekly. Ophthalmoscopic examinations of the eyes were performed pre-trial and again at weeks 12, 24 and 51. Clinical pathology examinations were performed pre-trial and at weeks, 12, 25 and 50. At the end of the treatment period the animals were sacrificed and necropsy examinations performed. Selected tissues were weighed and a full list of tissues processed for microscopic examination. All dogs survived the treatment period. No adverse effects were recorded for clinical signs, body weight, food intake, clinical pathology, macroscopic findings or organ weight. Microscopic findings of cytoplasmic pigment possibly indicating biliary stasis, was noted in the livers of the 1000 ppm males and females. In addition, there was trace hepatocellular hypertrophy in 2 of the 4 males from this group. None of these changes were associated with degenerative conditions. On the basis of the findings in the liver, the NOEL was considered to be 250 ppm which is equivalent to 7.5 mg/kg bw/day in males and 7.4 mg/kg bw/day in females based on average compound consumption. However, these changes suggested that the liver was involved in the metabolism and excretion of the test substance. Trace hepatocellular hypertrophy and cytoplasmic pigment in some animals reflected the additional work load as a consequence of ingestion of large quantities of test substance. Degenerative changes were not identified. Therefore, in the absence of degenerative changes occurring in the liver the systemic no-observed-adverse-effect-level (NOAEL) is 1000 ppm equivalent to 34.9/32.5 mg/kg bw/day in males/females.   Two 13-week dietary studies were performed in rat and mouse in order to assess possible toxicity of MGK 264 and select dose concentrations for the carcinogenicity studies in these species. These studies may be considered supporting studies only as a full microscopic examination of tissues was not performed. Nevertheless, liver changes either in weight, appearance or microscopically were reported and confirmed liver to be a target organ following administration of MGK 264 by the oral route. Subchronic toxicity by dermal application A 13-week dermal toxicity study of MGK 264 was performed in rabbits according to EPA OPP 82-3 (Subchronic dermal toxicity 90 days). Eighty New Zealand White rabbits (40 males and 40 females) were divided into four groups of 10 males and 10 females. Three groups received a solution of MGK 264 in corn oil, dermally, at dose levels of 10, 30 or 100 mg/kg/day. The remaining group received the vehicle (corn oil) alone, at the same dose volume (1 ml/kg) and served as a control. Dose levels in this study were selected based on the findings of 7 day and 14 day dose range finding studies in rabbits in which skin irritation was seen at dermal applications of 30 mg/kg bw/day or more. Animals were dosed once daily, 7 days a week for 13 weeks. The test article was left in contact with the skin for 6 hours a day under a semi-occlusive dressing. At the end of each exposure period, the backs were washed with soap and water. During the treatment period, bodyweights and food consumption were measured weekly and skin reactions and clinical observations were recorded daily. Ophthalmological examinations were carried out on all animals before treatment started and on control and high dose animals during week 13 of the study. Blood samples were taken for haematology and blood chemistry in week 13 of the study. At the end of the treatment period, all animals were killed, necropsied and the weights of the kidneys, liver and testes were recorded. A range of tissues was preserved for subsequent histopathology.   No treatment related effects were noted during the study. Microscopic examination identified minimal or moderate epidermal hyperplasia, with associated chronic inflammation in the dermis in many instances, present in the treated skin of the majority of control and high dose group animals. Focal scab formation and minimal hyperkeratosis were seen in a few control and treated animals. None of these findings were related to treatment. It was concluded that the administration of MGK 264 dermally to the rabbit, daily for 13 weeks, at dose levels up to 100 mg/kg/day was not associated with any overt signs of toxicity.   A 21-day dermal toxicity study was conducted in Crl:CD® (SD) rats to determine the potential of MGK® 264 to produce toxicity. Eighty healthy rats (40 males and 40 females) were selected for the test and equally distributed into four groups (5 males and 5 females per group). Dose levels tested were vehicle control (distilled water), 300, 600, and 1,000 mg/kg/day MGK 264. An appropriate amount of the test substance or distilled water (control group) was applied to the skin of each rat over a 22-day (males) or 23-day (females) period, 6 hours per day under occlusion, for 5 days per week. Prior to study initiation and again on Day 20, the eyes of all rats were examined by focal illumination and indirect ophthalmoscopy. The animals were observed daily for viability, signs of gross toxicity, and behavioural changes and weekly for a battery of detailed observations. The dose site of each animal was evaluated for dermal irritation once each week. Body weights were recorded twice during the acclimation period, prior to test initiation (Day 1), weekly thereafter and at terminal sacrifice. Individual food consumption was also recorded weekly. Blood was sampled from animals during Week 3 of the study and prior to terminal sacrifice for hematology, clinical biochemistry, and serology assessments. Gross necropsies were performed on all study rats, and selected organs and tissues were evaluated histologically in the control and high dose level groups. Treated and untreated skin sections were evaluated histologically for all study rats. There were no clinical observations, body weight, food consumption or food efficiency effects, organ weight changes, gross findings, clinical pathology, or histopathological alterations that were considered attributable to the dermal application of MGK® 264. In the treated groups, very slight to severe erythema and very slight to slight edema was observed over the course of the 21-day study. Although dermal application of MGK® 264 resulted in hyperplastic and inflammatory lesions at the treated skin site of both male and female rats at all doses studied, these findings were considered non adverse due to their non-systemic (localized) character and the apparent ability of the animals to recover from irritation upon cessation of treatment. Therefore, under the conditions of this study, a no-observed-adverse-effect level (NOAEL) for MGK® 264 following 3 weeks of dermal application for male and female rats was 1,000 mg/kg/day (the highest dose tested).   Subchronic toxicity by the inhalation route A 13-week inhalation toxicity study was performed according to EPA OPP 82-4 (90-day inhalation toxicity). The toxicity of MGK 264 was assessed when administered by whole-body inhalation as a liquid aerosol to rats for 6 hours per day, 5 days per week for 13 weeks. The target concentrations in this study were 0 (control; double group), 10, 40, 135 and 400 (double group) mg/m3. The highest concentration in the study represented the maximum exposure level of MGK 264 which could be generated at the appropriate particle size in the 1000 litre chambers that were used in the study. Recovery animals were included in the control and high exposure groups and were examined after a 13-week recovery period. Exposure levels were determined gravimetrically (4 times per day) and by gas chromatography (once per day). Particle size distribution measurements of the liquid aerosol were made once per chamber/day. The animals were observed for clinical signs during each exposure and weekly for detailed physical examinations. Body weight measurements were recorded pre-test and weekly. Ophthalmoscopy examinations were performed pre-test and at the end of the study. Blood samples were withdrawn for haematological and clinical chemistry examinations before the scheduled sacrifices at the end of the treatment or recovery periods. At necropsy examination, selected organs were weighed, a full list of organs were harvested and processed for histopathological examination. The mean MGK 264 exposure concentrations were determined to be 0, 0, 10±2 (mean± standard deviation), 43±6, 135±19, 400±28 and 407±41 mg/m3. Particle size distribution determinations indicated the test aerosol atmosphere was respirable in size to the rat. Particle size distribution determinations showed, on average, the mass median aerodynamic diameter to be 1.1 microns with a geometric standard deviation of 2.3. MGK 264 related changes were limited to reduced activity and excessive salivation during exposure in the high exposure groups and histopathological changes in the nasoturbinates, nasopharynx and larynx of the high exposure group. These changes which were reversible, were indicative of a localised, normal adaptive responses to an aerosol exposure and not indicative of systemic toxicity. The decreased activity was not considered to be a major detrimental response. On this basis, 135 mg/m3 was considered to be a NOAEL (no-observable-adverse-effect-level). Summary of repeat dose toxicity A comprehensive toxicity database is available for MGK 264 by the oral, dermal and inhalation application routes. These include a 90-day dermal toxicity study in the rabbit, a 90-day whole body inhalation toxicity study in the rat, repeat dose toxicity studies up to 1 year duration in the rat, mouse and dog and oncogenicity studies in the rat and mouse. The target organ for MGK 264 when administered orally, is the liver. Changes observed microscopically in the liver include cytoplasmic pigment and hepatocellular hypertrophy accompanied by increases in liver weight. Similar changes have been observed in most repeat dose studies including oncogenicity and reproductive toxicity studies. It is considered that these changes suggest that the liver and bile are involved in the metabolism and excretion of MGK 264 and are supported by metabolism and excretion data which demonstrate that enterohepatic circulation plays a role in the elimination of MGK 264 (Selim, S. 1992, 1993). Therefore, it may be concluded that these changes reflect the additional work load as a consequence of ingestion of large quantities of test substance. MGK 264 can be regarded as mildly toxic to the liver at high dose levels however degenerative changes were not observed and there was no increase in liver necrosis in studies up to 2 years duration. In the 13-week inhalation toxicity study, local point of contact toxicity was identified in the absence of systemic toxicity at the highest dose. The highest dose in the inhalation toxicity study (400 mg/m3) produced reversible microscopic changes in the nasoturbinates, nasopharynx and larynx. These were considered to be localized, normal adaptive responses to an aerosol exposure, and not indicative of systemic toxicity. In this study 135 mg/m3was considered to be the NOAEL (No-observable-adverse-effect-level). A maximum tolerated dose of 100 mg/kg bw/day was selected for the 90-day dermal toxicity study in the rabbit based on preliminary observations of dermal irritation at application rates starting at 30 mg/kg bw for 7 days. Additionally, dermal irritation was also noted in a 21-day dermal toxicity study in the rat, in which reversible hyperplastic and inflammatory skin reactions were noted at 300 mg/kg bw. However, following application of 100 mg/kg bw/day in the 90-day dermal toxicity study, systemic toxicity was not observed and therefore this study was considered inadequate to establish a dermal endpoint. For risk assessment purposes, an endpoint for dermal risk assessment will be derived from the dietary toxicity studies in which the liver was identified as a target organ for systemic toxicity.  Table 1 Summary of repeat dose toxicity of MGK 264 Study Dose levels NOAEL/NOAECSystemic or local Associated relevant effect 90-day inhalation toxicity rabbit(Newton, P., 1994) 0, 10, 40, 135, 400 mg/m3 Local NOAEC: ca.135 mg/m³ air (nominal)Systemic NOAEC: 400 mg/m3  Excessive salivation and decreased activity during the exposure period in the high exposure group; histopathology: Reversible changes related to the test material include changes in the nasoturbinates, nasopharynx and larynx indicative of a local effect of MGK 264. 90-day dermal toxicity rabbit(Lancaster, S., 1993) 10, 30, 100 mg/kg bw/day Systemic or local NOAEL: ca.100 mg/kg bw/day (nominal)   Administration of MGK 264 dermally to the rabbit for 13 weeks was not associated with any MGK 264 related adverse effects in any of the treatment groups. 21-day dermal toxicity rabbit(Mercel, D. 2006) 300, 600, 1000 mg/kg bw/day Systemic NOAEL:≥1000 mg/kg bw/day,Local NOAEL: < 300 mg/kg bw/day   Dermal application of MGK 264 resulted in lesions at treated skin sites at all doses studied; these findings were considered non-adverse due to non-systemic (localized) character and ability of animals to recover from irritation after treatment stopped. 1-year dietary toxicity study in dogs(Blair, M., 1991) 65, 250, 1000 ppm in the dietAverage compound consumption (male/female):2.1/2.0, 7.5/7.4, 34.9/32.5 mg/kg bw/day Systemic NOAEL - 1000 ppm equivalent to 34.9/32.5 mg/kg bw/day in males/females microscopic changes of brown pigment present in the liver and trace hepatocellular hypertrophy; no degenerative changes identified. Oncogenicity study in the mouse(Blair, M. 1991) 50, 400, 800 mg/kg bw/day Systemic NOEL: 50 mg/kg bw/day (nominal)Carcingenicity systemic NOEL: 800 mg/kg bw/day (nominal) no evidence of an oncogenic effect Changes in the liver and gallbladder at 400 mg/kg bw/day Oncogenicity study in the rat(Goldenthal, E.I., 1993) 50, 150, 450 mg/kg bw/day Systemic NOEL: 50 mg/kg bw/day (nominal)Carcingenicity systemic NOEL: 450 mg/kg bw/day (nominal)- no evidence of an oncogenic effect Body weight and weight gain decreased in animals receiving 450 mg/kg bw/day. Lower food consumption in 450 mg/kg bw/day females. Increased incidence of foci on the livers of animals treated at 450 mg/kg bw/day and an increased incidence of cysts in the liver in females from the 150 and 450 mg/kg bw/day groups. There were test article related microscopic findings in the livers of males and females from the 150 and 450 mg/kg bw/day groups and in the kidneys of 150 and 450 mg/kg bw/day females.There was no evidence of an oncogenic effect related to administration of the test article in this study at any dosage level. 2-generation reproductive toxicity study in the rat(Eiben, R., 2009) 400, 1600, 6400 ppm Parental systemic NOAEL 400 ppm (nominal), equivalent to 33/51 mg/kg bw/day in males/females The systemic NOAEL for reproductive parameters is 1600 ppm (127 mg/kg bw/day).  Treatment related effects on the kidney beginning at 1600 ppm (increased storage of pigment, basophilic cortical tubules, hyaline droplets in males) and liver beginning at 1600 ppm (hypertrophy and/or eosinophilic cytoplasmic change of centrilobular hepatocytes -both generations; Periportal hypertrophy increased in F0 females beginning at 1600 ppm; regarded as an adaptive response to a changed liver function and not considered as adverse). At 6400 ppm, the maternally toxic dose level, a pup weight depression was noted in most generations (in F2b pups already before Day 14 p.p.) indicating a reprotoxic effect. Developmental toxicity study in rats(Schardien, J., 1990) 100, 300, 1000 mg/kg bw/day Maternal animals systemic NOEL: 300 mg/kg (nominal)Developmental systemic NOEL - 1000 mg/kg bw/day (nominal)  Maternal toxicity occurred at 1000 mg/kg bw/day level - body weight gain inhibition. No developmental toxicity was seen; no treatment related fetal malformations and variations. Developmental toxicity study in rabbits(Schardien, J.L., 1987) 10, 30, 100 mg/kg bw/day Maternal animals:Systemic NOAEL: 100 mg/kg bw/day (nominal) Developmental systemic NOEL: 100 mg/kg bw/day (nominal) Treatment elicited maternally toxic effects (increased incidence of excessive salivation) at 100 mg/kg bw/day. No development toxic effects were seen at any dosage level.    NOAEL for systemic exposure based on changes in the liver 1. From the 1-year dietary toxicity study in dogs the systemic NOAEL was 1000 ppm equivalent to 34.9/32.5 mg/kg bw/day in males/females based on changes in the liver associated with an increased work load. 2. In the Oncogenicity study in the mouse, changes in the liver and gallbladder were present at 400 mg/kg bw/day and the Systemic NOEL was 50 mg/kg bw/day (nominal). 3. In the oncogenicity study in the rat, there were test article related microscopic findings in the livers of males and females from the 150 and 450 mg/kg bw/day groups. 4. From the 2-generation reproduction toxicity study in rats, the parental systemic NOAEL was 400 ppm (nominal), equivalent to 33/51 mg/kg bw/day in males/females. Treatment related effects on liver began at 1600 ppm (hypertrophy and/or eosinophilic cytoplasmic change of centrilobular hepatocytes in both generations whilst periportal hypertrophy was increased in F0 females beginning at 1600 ppm. It was noted that these changes were regarded as an adaptive response to a changed liver function and not considered as adverse.   Therefore, based on a review of the liver findings from the studies noted above, the lowest NOAEL was 32.5 mg/kg bw/day in the females from the 1 year dog study and this value may be taken as the definitive end point for the derivation of the DNEL for workers.   NOAEC for local effects A 13-week inhalation toxicity study in rats identified reversible changes in the nasoturbinates, nasopharynx and larynx indicative of localized, normal adaptive responses to an aerosol exposure and not indicative of systemic toxicity of MGK 264. On this basis a local effects DNEL for workers will be also be derived based on the NOAEC of 135 mg/m3 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e3ab74c-4a1e-4ddb-83ee-ff80cf1f1dd6/documents/26e1bba4-d933-47dc-9d56-07db0d74bfaa_cbac0390-5850-43f7-b942-4225278fc391.html,,,,,, "N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide",113-48-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e3ab74c-4a1e-4ddb-83ee-ff80cf1f1dd6/documents/26e1bba4-d933-47dc-9d56-07db0d74bfaa_cbac0390-5850-43f7-b942-4225278fc391.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,,rabbit "N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide",113-48-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e3ab74c-4a1e-4ddb-83ee-ff80cf1f1dd6/documents/26e1bba4-d933-47dc-9d56-07db0d74bfaa_cbac0390-5850-43f7-b942-4225278fc391.html,Chronic toxicity – systemic effects,oral,NOAEL,32.5 mg/kg bw/day,,dog "N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide",113-48-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e3ab74c-4a1e-4ddb-83ee-ff80cf1f1dd6/documents/26e1bba4-d933-47dc-9d56-07db0d74bfaa_cbac0390-5850-43f7-b942-4225278fc391.html,Repeated dose toxicity – local effects,inhalation,NOAEC,135 mg/m3,adverse effect observed,rat "N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide",113-48-4," Acute Oral Toxicity According to the OECD Test Guideline 425 Acute Oral Toxicity Statistical Program, the LD50 of MGK 264 was determined to be equal to 5000 mg/kg with a 95% confidence interval of 2736 to 6360 mg/kg. The acute oral median lethal dose (LD50) of the test material, in female Sprague-Dawley rats was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrases are required according to EEC labelling regulations. (EC 1272/2008) Inhalation Toxicity Under the conditions of this test, the acute inhalation LC50 of MGK 264 in the male rat was determined to be 1.94 mg/L. In the female rat, the acute inhalation LC50 was determined to be 1.94 mg/L. In the sexes combined, the LC50 was determined to be 1.98 mg/L. The acute inhalation lethal dose (LC50) of the test material, in female Sprague-Dawley rats (1.94 mg/L) was found to be between 1.0 and 5.0 mg/l. According to EC 1272/2008 this would be classified as a category 4 toxicity hazard for inhalation. Dermal Toxicity The acute dermal lethal dose (LD50) of the test material, in male and female Sprague-Dawley rats was found to be greater than 2000 mg/kg bodyweight. No symbol and risk phrases are required according to EEC labelling regulations. (EC 1272/2008) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e3ab74c-4a1e-4ddb-83ee-ff80cf1f1dd6/documents/478dae6b-04b1-4e60-848d-ece4edc0e5d7_cbac0390-5850-43f7-b942-4225278fc391.html,,,,,, "N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide",113-48-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e3ab74c-4a1e-4ddb-83ee-ff80cf1f1dd6/documents/478dae6b-04b1-4e60-848d-ece4edc0e5d7_cbac0390-5850-43f7-b942-4225278fc391.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide",113-48-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e3ab74c-4a1e-4ddb-83ee-ff80cf1f1dd6/documents/478dae6b-04b1-4e60-848d-ece4edc0e5d7_cbac0390-5850-43f7-b942-4225278fc391.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "N-(2-ethylhexyl)-8,9,10-trinorborn-5-ene-2,3-dicarboximide",113-48-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e3ab74c-4a1e-4ddb-83ee-ff80cf1f1dd6/documents/478dae6b-04b1-4e60-848d-ece4edc0e5d7_cbac0390-5850-43f7-b942-4225278fc391.html,,inhalation,LC50,"1,980 mg/m3",adverse effect observed, Ethyl 4-hydroxybenzoate,120-47-8,"NOAEL (rat, oral, 90 days): 1000 mg/kg bw/d based on read-across ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80eaeb90-af73-4910-b383-17cf1d1e4844/documents/611e8422-b05e-4401-9526-dcad4938e8b8_cecaf674-d645-435a-a3fc-54837319e44a.html,,,,,, Ethyl 4-hydroxybenzoate,120-47-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80eaeb90-af73-4910-b383-17cf1d1e4844/documents/611e8422-b05e-4401-9526-dcad4938e8b8_cecaf674-d645-435a-a3fc-54837319e44a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Ethyl 4-hydroxybenzoate,120-47-8,"Oral (OECD 401), rat: LD50 > 3100 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80eaeb90-af73-4910-b383-17cf1d1e4844/documents/f0ddfc46-f548-4c5d-b602-0be013761acb_cecaf674-d645-435a-a3fc-54837319e44a.html,,,,,, Ethyl 4-hydroxybenzoate,120-47-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80eaeb90-af73-4910-b383-17cf1d1e4844/documents/f0ddfc46-f548-4c5d-b602-0be013761acb_cecaf674-d645-435a-a3fc-54837319e44a.html,,oral,LD50,"3,100 mg/kg bw",adverse effect observed, Etidronic acid,2809-21-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): (active salt) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef50070b-0f81-481e-9f83-97af312fb786/documents/eedfc000-4304-4f81-8561-7662e37859ce_0367179c-3de8-49da-afe5-6ada95ecdc91.html,,,,,, Etidronic acid,2809-21-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef50070b-0f81-481e-9f83-97af312fb786/documents/eedfc000-4304-4f81-8561-7662e37859ce_0367179c-3de8-49da-afe5-6ada95ecdc91.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,34 mg/kg bw/day,,rat Etidronic acid,2809-21-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef50070b-0f81-481e-9f83-97af312fb786/documents/a46b9128-0953-45fc-a617-e6ce2c57c5de_0367179c-3de8-49da-afe5-6ada95ecdc91.html,,oral,LD50,"ca.1,878 mg/kg bw",no adverse effect observed, Etidronic acid,2809-21-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef50070b-0f81-481e-9f83-97af312fb786/documents/a46b9128-0953-45fc-a617-e6ce2c57c5de_0367179c-3de8-49da-afe5-6ada95ecdc91.html,,dermal,LD50,"> 3,505 mg/kg bw",no adverse effect observed, Etocrilene,5232-99-5,"In a subchronic study with rats (BASF SE, 2022) the test substance did not cause any adverse effects up to the highest dose tested (1000 mg/kg), therefore, the NOAEL was set at 1000 mg/kg bw ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41efb940-26cc-47c1-a866-29307f8c7087/documents/1a62ad63-e54e-4507-a9a6-61ce9c079a22_c632e169-67f7-45d3-bfcb-3df48eea61ca.html,,,,,, Etocrilene,5232-99-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41efb940-26cc-47c1-a866-29307f8c7087/documents/1a62ad63-e54e-4507-a9a6-61ce9c079a22_c632e169-67f7-45d3-bfcb-3df48eea61ca.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Etocrilene,5232-99-5,Acute oral toxicity: LD50 > 16000 mg/kg bw Acute dermal toxicity: LD50 > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41efb940-26cc-47c1-a866-29307f8c7087/documents/b43b4111-3daa-421c-9812-82278690ddf9_c632e169-67f7-45d3-bfcb-3df48eea61ca.html,,,,,, Etocrilene,5232-99-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41efb940-26cc-47c1-a866-29307f8c7087/documents/b43b4111-3daa-421c-9812-82278690ddf9_c632e169-67f7-45d3-bfcb-3df48eea61ca.html,,oral,LD50,"16,000 mg/kg bw",no adverse effect observed, Etocrilene,5232-99-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41efb940-26cc-47c1-a866-29307f8c7087/documents/b43b4111-3daa-421c-9812-82278690ddf9_c632e169-67f7-45d3-bfcb-3df48eea61ca.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Cineole,470-82-6,The test substance was assessed for repeated dose oral toxicity according to OECD 407. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc659514-8414-48d6-ba50-616b3ba95689/documents/IUC5-e23f82f5-ddaf-4fee-a33c-cd86f66913d0_d106fed1-ac5d-42b7-bf86-04be9164fc38.html,,,,,, Cineole,470-82-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc659514-8414-48d6-ba50-616b3ba95689/documents/IUC5-e23f82f5-ddaf-4fee-a33c-cd86f66913d0_d106fed1-ac5d-42b7-bf86-04be9164fc38.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat Cineole,470-82-6,"Acute oral: A key study was not available on the target substance therefore data was presented on the read across substance, Clarycet. The acute median lethal oral dose for males and females combined were 4.5 g/kg body weight; for males only it was estimated to be 4.7 g/kg body weight (and for females only was 4.3 g/kg body weight Acute dermal: A key study was not available on the target substance therefore data was presented on the read across substance, Clarycet. The LD50 of Clarycet was > 2.0 g/kg bodyweight; a supporting study on the target substance itself had an LD50 of 5.0 g/kg bodyweight. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc659514-8414-48d6-ba50-616b3ba95689/documents/IUC5-254280c5-13a1-404b-aa75-bb0a7ff00f73_d106fed1-ac5d-42b7-bf86-04be9164fc38.html,,,,,, Cineole,470-82-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc659514-8414-48d6-ba50-616b3ba95689/documents/IUC5-254280c5-13a1-404b-aa75-bb0a7ff00f73_d106fed1-ac5d-42b7-bf86-04be9164fc38.html,,oral,LD50,"4,500 mg/kg bw",no adverse effect observed, Cineole,470-82-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc659514-8414-48d6-ba50-616b3ba95689/documents/IUC5-254280c5-13a1-404b-aa75-bb0a7ff00f73_d106fed1-ac5d-42b7-bf86-04be9164fc38.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Eucalyptus maculata citriodora, ext.",85203-56-1, Repeated dose toxicity (OECD TG 422): NOAEL > 1085 mg/kg bw/day for males and 767 mg/kg bw/day for females ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb016d7a-c488-4260-b90f-01c5a3e7ea96/documents/2c374631-fd21-47d6-a27c-6fc117f9ba9e_694c049f-a9b1-4085-a1d4-a4608123dcb3.html,,,,,, "Eucalyptus maculata citriodora, ext.",85203-56-1,Acute oral toxicity: LD50 >5000 mg/kg bw (similar to OECD401)Acute dermal toxicity: LD50 = 2480 mg/kg bw (similar to OECD402) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb016d7a-c488-4260-b90f-01c5a3e7ea96/documents/IUC5-30a133d9-7fe6-476d-9eea-8a042268e732_694c049f-a9b1-4085-a1d4-a4608123dcb3.html,,,,,, "Eucalyptus maculata citriodora, ext.",85203-56-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb016d7a-c488-4260-b90f-01c5a3e7ea96/documents/IUC5-30a133d9-7fe6-476d-9eea-8a042268e732_694c049f-a9b1-4085-a1d4-a4608123dcb3.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Eucalyptus maculata citriodora, ext.",85203-56-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb016d7a-c488-4260-b90f-01c5a3e7ea96/documents/IUC5-30a133d9-7fe6-476d-9eea-8a042268e732_694c049f-a9b1-4085-a1d4-a4608123dcb3.html,,dermal,LD50,"2,480 mg/kg bw",no adverse effect observed, "Eucalyptus globulus, ext.",84625-32-1,"In an OECD 422 study, NOAELs for systemic toxicity were considered to be 300 and 1000 mg/kg bw/day for females and males rats, respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ddd3ac7e-1531-4ed6-a223-2d2bd1b1d566/documents/IUC5-807b7420-0501-4566-bd49-ab15e6bbf87e_d9fa1938-0264-4aeb-abaf-5a18d2513fe9.html,,,,,, "Eucalyptus globulus, ext.",84625-32-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ddd3ac7e-1531-4ed6-a223-2d2bd1b1d566/documents/IUC5-807b7420-0501-4566-bd49-ab15e6bbf87e_d9fa1938-0264-4aeb-abaf-5a18d2513fe9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Eucalyptus globulus, ext.",84625-32-1,"Acute toxicity, oral: LD50 = 3320 mg/kg bw (WoE).Acute toxicity, dermal: LD50 > 5000 mg/kg bw (Rel 2, K).Acute toxicity: inhalation: waiver. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ddd3ac7e-1531-4ed6-a223-2d2bd1b1d566/documents/IUC5-9656202d-c749-407c-bb5d-f4a9de7464a5_d9fa1938-0264-4aeb-abaf-5a18d2513fe9.html,,,,,, "Eucalyptus globulus, ext.",84625-32-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ddd3ac7e-1531-4ed6-a223-2d2bd1b1d566/documents/IUC5-9656202d-c749-407c-bb5d-f4a9de7464a5_d9fa1938-0264-4aeb-abaf-5a18d2513fe9.html,,oral,LD50,"3,320 mg/kg bw",no adverse effect observed, "Eucalyptus globulus, ext.",84625-32-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ddd3ac7e-1531-4ed6-a223-2d2bd1b1d566/documents/IUC5-9656202d-c749-407c-bb5d-f4a9de7464a5_d9fa1938-0264-4aeb-abaf-5a18d2513fe9.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Eucalyptus radiata australiana, ext.",92201-64-4,"Oral LD50 (mouse) = 3320 mg/kg bw (Ohsumi, 1984, Rel.4, WoE). Dermal Not required for Annex VII under REACH regulation. Inhalation Not required for Annex VII under REACH regulation. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Only basic data given in the two available studies, however results are consistent and were therefore considered sufficiently robust to cover this endpoint. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4bce1b53-9cbd-4ff2-be8a-18914d3d2618/documents/17c091fb-f960-45c4-a3f5-d9eec51d6c53_c75621fb-49b1-48cf-a2d7-9aeeaa8bd26b.html,,,,,, "Eucalyptus radiata australiana, ext.",92201-64-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4bce1b53-9cbd-4ff2-be8a-18914d3d2618/documents/17c091fb-f960-45c4-a3f5-d9eec51d6c53_c75621fb-49b1-48cf-a2d7-9aeeaa8bd26b.html,,oral,LD50,"3,320 mg/kg bw",no adverse effect observed, Eugenol,97-53-0,"Weight-of-evidence NOAEL = 300 mg/kg bw/d (Chronic study, rats, Rel.2) The available information as a whole meets the tonnage driven data requirement of REACH. Moreover, reliability and consistency are observed across the different studies. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/84128012-ebe8-4019-97b8-e20989854ca2/documents/3ed3e55f-7d30-4f74-abf4-9da8a89df571_8d206461-8c32-4109-aef7-7b8218bb0b41.html,,,,,, Eugenol,97-53-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/84128012-ebe8-4019-97b8-e20989854ca2/documents/3ed3e55f-7d30-4f74-abf4-9da8a89df571_8d206461-8c32-4109-aef7-7b8218bb0b41.html,Chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Eugenol,97-53-0,"Oral, LD50 > 2,000 mg/kg bw, rat (NTP, 1983)Oral, LD50 > 1,500 - <3,000 mg/kg bw, mouse (NTP, 1983)Inhalation, LC50 > 2.6 mg/L, rat (Clark, 1988) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84128012-ebe8-4019-97b8-e20989854ca2/documents/9307aa73-8853-4ce7-baa4-94a111f29284_8d206461-8c32-4109-aef7-7b8218bb0b41.html,,,,,, Eugenol,97-53-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84128012-ebe8-4019-97b8-e20989854ca2/documents/9307aa73-8853-4ce7-baa4-94a111f29284_8d206461-8c32-4109-aef7-7b8218bb0b41.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Eugenol,97-53-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84128012-ebe8-4019-97b8-e20989854ca2/documents/9307aa73-8853-4ce7-baa4-94a111f29284_8d206461-8c32-4109-aef7-7b8218bb0b41.html,,inhalation,LC50,"2,600 mg/m3",no adverse effect observed, 4-allyl-2-methoxyphenyl acetate,93-28-7,"Acute toxicity: lowest oral: LD50 = 1670 mg/kg bw (pre-OECD and pre-GLP, WoE, rel. 4) in rats;Acute toxicity: dermal: LD50 > 5000 mg/kg bw (similar to OECD 402, K, rel. 2) in rabbits. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d2b9e7c-defb-411e-a2d0-02f3b208fd2c/documents/73b4e7c6-d87f-425f-9937-0a8b7dbac312_42439990-233e-4c63-8b2d-49d2c483d937.html,,,,,, 4-allyl-2-methoxyphenyl acetate,93-28-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d2b9e7c-defb-411e-a2d0-02f3b208fd2c/documents/73b4e7c6-d87f-425f-9937-0a8b7dbac312_42439990-233e-4c63-8b2d-49d2c483d937.html,,oral,LD50,"1,670 mg/kg bw",adverse effect observed, 4-allyl-2-methoxyphenyl acetate,93-28-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d2b9e7c-defb-411e-a2d0-02f3b208fd2c/documents/73b4e7c6-d87f-425f-9937-0a8b7dbac312_42439990-233e-4c63-8b2d-49d2c483d937.html,,dermal,LD50,"5,000 mg/kg bw",adverse effect observed, "(E)-7,11-dimethyl-3-methylenedodeca-1,6,10-triene",18794-84-8,Rat 90 -day (OECD 408) oral NOAEL: 1000 mg/Kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0fa03d6f-1c7a-490a-bc8a-2c2e26ad26c2/documents/06a5f749-3f37-4f64-a6f0-30a1f8a6b5b9_bbf0035c-877f-49bd-9e64-738e9b3f5144.html,,,,,, "(E)-7,11-dimethyl-3-methylenedodeca-1,6,10-triene",18794-84-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0fa03d6f-1c7a-490a-bc8a-2c2e26ad26c2/documents/06a5f749-3f37-4f64-a6f0-30a1f8a6b5b9_bbf0035c-877f-49bd-9e64-738e9b3f5144.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "(E)-7,11-dimethyl-3-methylenedodeca-1,6,10-triene",18794-84-8,"Key studies were completed for each of the three exposure routes ( oral, inhalation and dermal) for the substance under GLP conditions and in accordance or equivalent to EU and OECD methods. There were no mortalities in the studies. The acute oral and dermal LD50 values were > 5000 mg/kg and the inhalation LC50 (aerosol) was > 2060 mg/m3 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fa03d6f-1c7a-490a-bc8a-2c2e26ad26c2/documents/5e9ecf8b-ddc6-4fd5-8d47-1b822a7530aa_bbf0035c-877f-49bd-9e64-738e9b3f5144.html,,,,,, "(E)-7,11-dimethyl-3-methylenedodeca-1,6,10-triene",18794-84-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fa03d6f-1c7a-490a-bc8a-2c2e26ad26c2/documents/5e9ecf8b-ddc6-4fd5-8d47-1b822a7530aa_bbf0035c-877f-49bd-9e64-738e9b3f5144.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "(E)-7,11-dimethyl-3-methylenedodeca-1,6,10-triene",18794-84-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fa03d6f-1c7a-490a-bc8a-2c2e26ad26c2/documents/5e9ecf8b-ddc6-4fd5-8d47-1b822a7530aa_bbf0035c-877f-49bd-9e64-738e9b3f5144.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "(E)-7,11-dimethyl-3-methylenedodeca-1,6,10-triene",18794-84-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fa03d6f-1c7a-490a-bc8a-2c2e26ad26c2/documents/5e9ecf8b-ddc6-4fd5-8d47-1b822a7530aa_bbf0035c-877f-49bd-9e64-738e9b3f5144.html,,inhalation,LC50,"> 2,060 mg/m3",no adverse effect observed, Farnesol,4602-84-0," The key information supporting the repeat dose toxicity of the test item included a regulatory subchronic repeated dose toxicity study with reproductive toxicity screen by oral administration (inclusion levels in the feed of 1500, 4000 and 12000 ppm) of the read-across substance, Nerolidol, in rats (OECD 422) conducted to GLP. In this study No Observed Adverse Effect Levels (NOAELs) were established following repeated daily treatment to the parent animals. Read-across is appropriate as the test substance and nerolidol are very similar in chemical structure, differing only by the interchange of a hydroxyl group and double bond on carbon positions 1 and 2, and very similar in physico-chemical properties. The oral and dermal acute and repeat dose toxicity data show that the toxicity of farnesol and nerolidol are similar in order of magnitude when comparing dose levels expressed in terms of mg/kg bodyweight. Given the similarities in chemical and biological effects, nerolidol is considered to be a suitable read-across substance. A supporting study of 28 days duration in rats by daily oral gavage administration at 500 or 1000 mg/kg/day also incorporated a recovery period and was extended to assess hepatotoxicity by analysing drug metabolising enzyme activities. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8b72e4f-c28e-40e3-98f3-d64a091bc1ed/documents/ede971ab-ab83-4101-8ee3-1323d05b0663_ed851b78-93b4-439a-8ce4-7a799f4c148a.html,,,,,, Farnesol,4602-84-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8b72e4f-c28e-40e3-98f3-d64a091bc1ed/documents/ede971ab-ab83-4101-8ee3-1323d05b0663_ed851b78-93b4-439a-8ce4-7a799f4c148a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,105 mg/kg bw/day,,rat Farnesol,4602-84-0," Acute oral toxicity: The oral LD50 could not be calculated as there was no effect on mortality in the study. Therefore the oral LD50 in rats is considered to be >20 mL/kg, which, based on a density of 0.888, is equivalent to >17760 mg/kg. Acute inhalation toxicity: This endpoint is waived as adequate data from acute studies via oral and dermal routes are available. Acute dermal toxicity: The dermal LD50 could not be calculated as there was no effect on mortality in the study. Therefore the dermal LD50 in rats is considered to be >15000 mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8b72e4f-c28e-40e3-98f3-d64a091bc1ed/documents/8e6cacab-fc7c-46c5-a30b-47de6811feb8_ed851b78-93b4-439a-8ce4-7a799f4c148a.html,,,,,, Farnesol,4602-84-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8b72e4f-c28e-40e3-98f3-d64a091bc1ed/documents/8e6cacab-fc7c-46c5-a30b-47de6811feb8_ed851b78-93b4-439a-8ce4-7a799f4c148a.html,,oral,LD50,"17,760 mg/kg bw",no adverse effect observed, Farnesol,4602-84-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8b72e4f-c28e-40e3-98f3-d64a091bc1ed/documents/8e6cacab-fc7c-46c5-a30b-47de6811feb8_ed851b78-93b4-439a-8ce4-7a799f4c148a.html,,dermal,LD50,"15,000 mg/kg bw",no adverse effect observed, "3,3-dimethyl-8,9-dinorbornan-2-one",1195-79-5," Acute oral toxicity:  Acute oral toxicity dose (LD50) of 3,3-Dimethyl-8,9-dinorbornan-2-one (CAS no: 1195-79-5) was considered based on different experimental studies conducted by Steven et al.(Weed Science, Vol. 44, No. 1, pp. 7-11, Jan. - Mar., 1996) 4400 mg/kg bw in rat; D. L. J. Opdyke (Food and Cosmetics Toxicology, Volume 14, Supplement, 1976, Pages 769-771) and Robert et al.(Essential Oil Safety (Second Edition), A Guide for Health Care Professionals, 2014, Pages 483–647) 6160 mg/kg bw in rat; Petros et al.(Regulated Chemicals Directory 1995, 2012)12750 mg/kg bw in mice; and based on OECD QSAR toolbox 2687 mg/kg bw and different studies available on structurally similar read across substances (1S)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-one (CAS no: 4695-62-9)6160 mg/kg bw; and 1,3,3-Trimethyl-2-oxabicyclo[2.2.2]octane (CAS no: 470-82-6) 2480 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 3,3-Dimethyl-8,9-dinorbornan-2-one cannot be classified for acute oral toxicity. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for 3,3-Dimethyl-8,9-dinorbornan-2-one (CAS no: 1195-79-5) was considered based on experimental study conducted by D. L. J. Opdyke (Food and Cosmetics Toxicology, Volume 14, Supplement, 1976, Pages 769-771) and Robert et al.(Essential Oil Safety (Second Edition), A Guide for Health Care Professionals, 2014, Pages 483–647) >5000 mg/kg bw; predicted based on OECD QSAR toolbox 3446 mg/kg bw and studies available for the structurally similar read across substances Exo-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol (CAS no: 124-76-5) >5000 mg/kg bw and 4-tert-Butylcyclohexanone (CAS no: 98-53-3) 5000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 3,3-Dimethyl-8,9-dinorbornan-2-one cannot be classified for acute dermal toxicity. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/147e3935-dec8-4cd8-9879-2fb91dca9599/documents/d663a483-2c72-4dd8-aa6f-b9e0b51e8c7a_500b9dc5-4c4f-4a6c-95c8-25368fc862dc.html,,,,,, "3,3-dimethyl-8,9-dinorbornan-2-one",1195-79-5,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/147e3935-dec8-4cd8-9879-2fb91dca9599/documents/d663a483-2c72-4dd8-aa6f-b9e0b51e8c7a_500b9dc5-4c4f-4a6c-95c8-25368fc862dc.html,,oral,LD50,"4,400 mg/kg bw",no adverse effect observed, "3,3-dimethyl-8,9-dinorbornan-2-one",1195-79-5,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/147e3935-dec8-4cd8-9879-2fb91dca9599/documents/d663a483-2c72-4dd8-aa6f-b9e0b51e8c7a_500b9dc5-4c4f-4a6c-95c8-25368fc862dc.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Ammonium iron(III) citrate,1185-57-5," Repeated dose toxicity: Oral The No Observed Adverse Effect Level (NOAEL) of the test chemical in the rat via oral route of exposure is considered to be in the dose range of 601 -1200 mg/kg bw/day.4 mg/kg body weight in male and female animals. Repeated dose toxicity: Inhalation a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment.Test chemical has very low vapor pressure of 3.29e-09 Pa.( 2.4677e-11 mmHg). Also, the test chemical has a particle size distribution of 52-147 micron, so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route is considered for waiver. Repeated dose toxicity: Dermal a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. The acute dermal toxicity value for Ferric ammonium citrate (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not sensitizing to the skin. Based on these considerations, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4fb6a962-6744-4dc3-b863-6519b312be77/documents/3b082933-4bf9-4780-b711-b2bcc2deb406_c6b3ab0d-fd74-4efc-a48b-70ff9018893a.html,,,,,, Ammonium iron(III) citrate,1185-57-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4fb6a962-6744-4dc3-b863-6519b312be77/documents/3b082933-4bf9-4780-b711-b2bcc2deb406_c6b3ab0d-fd74-4efc-a48b-70ff9018893a.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat Ammonium iron(III) citrate,1185-57-5," Acute oral toxicity:  The acute oral toxicity of test chemical was assessed in various experimental studies.Based on the available key and supporting studies,it can be concluded that LD50 of test chemical is >2000 mg/kg bw. Thus, comparing the above annotations with the criteria of CLP regulation, it cannot be classified for acute oral toxicity.   Acute Inhalation toxicity: the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size (The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 3.29e-09 Pa.( 2.4677e-11 mmHg). Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. )   Acute Dermal toxicity: Data available for the structurally and functionally similar test chemicals have been reviewed to determine the acute dermal toxicity of the test chemical. Based on the summarized,it can be concluded that theLD50 value of test chemical is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fb6a962-6744-4dc3-b863-6519b312be77/documents/6ba22b15-eddd-436d-b741-81a3559614d7_c6b3ab0d-fd74-4efc-a48b-70ff9018893a.html,,,,,, Ammonium iron(III) citrate,1185-57-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fb6a962-6744-4dc3-b863-6519b312be77/documents/6ba22b15-eddd-436d-b741-81a3559614d7_c6b3ab0d-fd74-4efc-a48b-70ff9018893a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ammonium iron(III) citrate,1185-57-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fb6a962-6744-4dc3-b863-6519b312be77/documents/6ba22b15-eddd-436d-b741-81a3559614d7_c6b3ab0d-fd74-4efc-a48b-70ff9018893a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Iron trichloride,7705-08-0,"- Repeated dose toxicity, oral: • FeCl3: no classification, NOAEL = 277 mg/kg bw/d, LOAEL = 554 mg/kg bw/d, 1 study (probably comparable to OECD TG 408) • Fe2(SO4)3: no classification, no studies available, accordingly read across is used from FeCl3: NOAEL = 277 mg/kg bw/d * (399.88 g/mol/2 * 162.21 g/mol) = 341.4 mg/kg bw/d, LOAEL = 683 mg/kg bw/d • FeCl2: no classification (as treatment period was at least 42 d and dosed 7 d/week), NOAEL = 125 mg/kg bw, LOAEL: 250 mg/kg bw, 1 study (compliant to OECD TG 422 and GLP • FeSO4: no classification (effects at 163.9 mg/kg bw/d not sufficient for classification), NOAEL = 54.6 mg/kg bw, LOAEL = 163.9 mg/kg bw/d for anhydrous FeSO4, 1 study (compliant to OECD TG 422 and GLP) • FeClSO4: no classification, no studies available, accordingly read across is used from FeCl3: NOAEL = 277 mg/kg bw/d * (187.36 g/mol/62.21 g/mol) = 319.9 mg/kg bw/d, LOAEL = 639.9 mg/kg bw/d- Repeated dose toxicity, dermal: no studies available- Repeated dose toxicity, inhalation: • FeCl3: one reliable but not sufficient conclusive for classification study in rabbits reported a LOAEL of 1.4 mg Fe/m³, when exposed to FeCl3 aerosol ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8896a5b1-9912-4ee1-94f5-22428d14d830/documents/IUC5-3ecae4c3-d7c3-4a0d-9154-a61f65eb5028_df1aea86-8745-4e0c-ac97-4649c3350de8.html,,,,,, Iron trichloride,7705-08-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8896a5b1-9912-4ee1-94f5-22428d14d830/documents/IUC5-3ecae4c3-d7c3-4a0d-9154-a61f65eb5028_df1aea86-8745-4e0c-ac97-4649c3350de8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Iron trichloride,7705-08-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8896a5b1-9912-4ee1-94f5-22428d14d830/documents/IUC5-3ecae4c3-d7c3-4a0d-9154-a61f65eb5028_df1aea86-8745-4e0c-ac97-4649c3350de8.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1.4 mg/m3,adverse effect observed,rabbit Iron trichloride,7705-08-0,"Acute toxicity, oral: H302: Harmful if swallowed, Category 4, OECD TG 423; study Choi 2005Acute toxicity, inhalation: No adverse effect observed in limit study, EPA OPP 81-3; US EPA 1993/Robbins 1991Acute toxicity, dermal: Non-toxic, OECD TG 402; study Choi 2004 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8896a5b1-9912-4ee1-94f5-22428d14d830/documents/IUC5-c5144fba-022d-47fa-a3aa-43ce20a9a67f_df1aea86-8745-4e0c-ac97-4649c3350de8.html,,,,,, Iron trichloride,7705-08-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8896a5b1-9912-4ee1-94f5-22428d14d830/documents/IUC5-c5144fba-022d-47fa-a3aa-43ce20a9a67f_df1aea86-8745-4e0c-ac97-4649c3350de8.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Iron trichloride,7705-08-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8896a5b1-9912-4ee1-94f5-22428d14d830/documents/IUC5-c5144fba-022d-47fa-a3aa-43ce20a9a67f_df1aea86-8745-4e0c-ac97-4649c3350de8.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Iron trichloride,7705-08-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8896a5b1-9912-4ee1-94f5-22428d14d830/documents/IUC5-c5144fba-022d-47fa-a3aa-43ce20a9a67f_df1aea86-8745-4e0c-ac97-4649c3350de8.html,,inhalation,discriminating conc.,"1,100 mg/m3",no adverse effect observed, Diiron tris(sulphate),10028-22-5,"- Repeated dose toxicity, oral: • FeCl3: no classification, NOAEL = 277 mg/kg bw/d, LOAEL = 554 mg/kg bw/d, 1 study (probably comparable to OECD TG 408) • Fe2(SO4)3: no classification, no studies available, accordingly read across is used from FeCl3: NOAEL = 277 mg/kg bw/d * (399.88 g/mol/2 * 162.21 g/mol) = 341.4 mg/kg bw/d, LOAEL = 683 mg/kg bw/d • FeCl2: no classification (as treatment period was at least 42 d and dosed 7 d/week), NOAEL = 125 mg/kg bw, LOAEL: 250 mg/kg bw, 1 study (compliant to OECD TG 422 and GLP • FeSO4: no classification (effects at 163.9 mg/kg bw/d not sufficient for classification), NOAEL = 54.6 mg/kg bw, LOAEL = 163.9 mg/kg bw/d for anhydrous FeSO4, 1 study (compliant to OECD TG 422 and GLP) • FeClSO4: no classification, no studies available, accordingly read across is used from FeCl3: NOAEL = 277 mg/kg bw/d * (187.36 g/mol/62.21 g/mol) = 319.9 mg/kg bw/d, LOAEL = 639.9 mg/kg bw/d- Repeated dose toxicity, dermal: no studies available- Repeated dose toxicity, inhalation: • FeCl3: one reliable but not sufficient conclusive for classification study in rabbits reported a LOAEL of 1.4 mg Fe/m³, when exposed to FeCl3 aerosol ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39ba9aac-ee5a-41d3-9c2f-0a239f6af47b/documents/48a92e03-8b84-405a-bd36-022543d788e8_d320bfa6-1a02-4214-ba2f-253eff06ffd0.html,,,,,, Diiron tris(sulphate),10028-22-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39ba9aac-ee5a-41d3-9c2f-0a239f6af47b/documents/48a92e03-8b84-405a-bd36-022543d788e8_d320bfa6-1a02-4214-ba2f-253eff06ffd0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Diiron tris(sulphate),10028-22-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39ba9aac-ee5a-41d3-9c2f-0a239f6af47b/documents/48a92e03-8b84-405a-bd36-022543d788e8_d320bfa6-1a02-4214-ba2f-253eff06ffd0.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1.4 mg/m3,adverse effect observed,rabbit Diiron tris(sulphate),10028-22-5,"Acute toxicity, oral: H302: Harmful if swallowed, Category 4, OECD TG 423; study Choi 2004aAcute toxicity, inhalation: No adverse effect observed in limit study, EPA OPP 81-3; US EPA 1993/Robbins 1991Acute toxicity, dermal: Non-toxic, OECD TG 402; study Choi 2004b ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39ba9aac-ee5a-41d3-9c2f-0a239f6af47b/documents/1962f494-5d0f-4bef-829d-2ec930621496_d320bfa6-1a02-4214-ba2f-253eff06ffd0.html,,,,,, Diiron tris(sulphate),10028-22-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39ba9aac-ee5a-41d3-9c2f-0a239f6af47b/documents/1962f494-5d0f-4bef-829d-2ec930621496_d320bfa6-1a02-4214-ba2f-253eff06ffd0.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Diiron tris(sulphate),10028-22-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39ba9aac-ee5a-41d3-9c2f-0a239f6af47b/documents/1962f494-5d0f-4bef-829d-2ec930621496_d320bfa6-1a02-4214-ba2f-253eff06ffd0.html,,dermal,discriminating dose,881 mg/kg bw,no adverse effect observed, Diiron tris(sulphate),10028-22-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39ba9aac-ee5a-41d3-9c2f-0a239f6af47b/documents/1962f494-5d0f-4bef-829d-2ec930621496_d320bfa6-1a02-4214-ba2f-253eff06ffd0.html,,inhalation,discriminating conc.,300 mg/m3,no adverse effect observed, Iron(II) fumarate,141-01-5," Repeated Dose toxicity- Oral Subacute repeated dose oral toxicity study was performed to determine the oral toxic nature of the test chemical using rats. The study was performed on 5 male and 5 females rats per group at dose levels of 0, 50 or 100 mg/Kg for 12 weeks. The animals were observed for changes in body weight, hematology parameters, organ weight changes were noted and histological parameters were noted. An increase in group mean body weight was observed after 12 weeks. At higher dose levels (100 mg/Kg), depressed growth rate in the male rats was noted but the effect was not observed in female rats. At 50 mg/Kg, the depression in growth rate produced in the male rats was not significant. No abnormalities were found in the red and total white cell counts or hemoglobin concentration. None of the organ weights in the dosed group differed significantly (P: 0.05) from those of the controls. Histological examination of the organs did not reveal the abnormalities apart from slight and variable increase in the iron deposition in the tissue phagocytes. Based on the observation made, the No Observed Adverse Effect  Level (NOAEL) for the test chemical was considered to be 50 mg/Kg using albino rats of WAG strain.   Repeated dose toxicity -Inhalation A short-term toxicity study doesnot need to be conducted because exposure of humans via inhalation in production/use is not likely based on the thorough and rigorous risk assessment provided. The vapor pressure of the test chemical was estimated to be 5.347939035779555e-7 mmHg at 25 degrees C. Hence, the endpoint can be considered for waiver Repeated dose toxicity -Dermal A short-term toxicity study doesnot need to be conducted because exposure of humans via dermal route in production/use is not likely based on the thorough and rigorous risk assessment provided. The test chemical is used as a dietary supplement in humans. The primary route of exposure of the test chemical is oral. Hence, this endpoint can be considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/feb33982-5639-4add-bc83-8ad5b081189e/documents/6dbfd5f4-03a7-47f5-871e-ddbf2d58e872_cb2f1bf0-0db0-4440-84de-ba8bc9639d84.html,,,,,, Iron(II) fumarate,141-01-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/feb33982-5639-4add-bc83-8ad5b081189e/documents/6dbfd5f4-03a7-47f5-871e-ddbf2d58e872_cb2f1bf0-0db0-4440-84de-ba8bc9639d84.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Iron(II) fumarate,141-01-5," Acute toxicity oral In an acute oral toxicity study,rats were dosed with the test chemical orally. 50 % mortality was observed in treated rats at 3850 mg/kg bw. Therefore,LD50 was considered to be 3850 mg/kgbw when rat were treated with the test chemical orally. Acute toxicity inhalation The study doesnot need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The vapor pressure of the test chemical was estimated to be 5.347939035779555e-7 mmHg at 25 degrees C. Hence, the endpoint can be considered for waiver   Acute toxicity dermal The study doesnot need to be conducted because skin contact in production and/or use is not likely. The test chemical is used as a dietary supplement in humans. The primary route of exposure of the test chemical is oral. Hence, this endpoint can be considered for waiver. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/feb33982-5639-4add-bc83-8ad5b081189e/documents/0d20cb9f-164d-408f-ae0f-4408979d83cc_cb2f1bf0-0db0-4440-84de-ba8bc9639d84.html,,,,,, Iron(II) fumarate,141-01-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/feb33982-5639-4add-bc83-8ad5b081189e/documents/0d20cb9f-164d-408f-ae0f-4408979d83cc_cb2f1bf0-0db0-4440-84de-ba8bc9639d84.html,,oral,LD50,"3,850 mg/kg bw",no adverse effect observed, Iron digluconate,299-29-6,"There are no repeat dose toxicity: via oral route studies on ferrous gluconate. Results of a study conducted with a structurally similar compounds, D-glucono-1,5 -lactone and iron (II) chloride, are reported and used for read across. Via read read across Iron Gluconate is classified as non-hazardous for this end point. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e20a42b7-5a9e-477a-9579-adca86bed065/documents/IUC5-210140e4-0fa6-49c5-b0e8-e0fc98352d56_6d7bb6f6-ef82-4d51-9e1e-a7547bf183e0.html,,,,,, Iron digluconate,299-29-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e20a42b7-5a9e-477a-9579-adca86bed065/documents/IUC5-210140e4-0fa6-49c5-b0e8-e0fc98352d56_6d7bb6f6-ef82-4d51-9e1e-a7547bf183e0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Iron digluconate,299-29-6,Via study data and read across Iron Gluconate is not classified as toxicJustification for using read across for the actute toxicity via the dermal route is attached. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e20a42b7-5a9e-477a-9579-adca86bed065/documents/IUC5-db26c027-2f5d-40dd-be3c-2cdf181051f4_6d7bb6f6-ef82-4d51-9e1e-a7547bf183e0.html,,,,,, Iron digluconate,299-29-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e20a42b7-5a9e-477a-9579-adca86bed065/documents/IUC5-db26c027-2f5d-40dd-be3c-2cdf181051f4_6d7bb6f6-ef82-4d51-9e1e-a7547bf183e0.html,,oral,LD50,"2,237 mg/kg bw",no adverse effect observed, Iron digluconate,299-29-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e20a42b7-5a9e-477a-9579-adca86bed065/documents/IUC5-db26c027-2f5d-40dd-be3c-2cdf181051f4_6d7bb6f6-ef82-4d51-9e1e-a7547bf183e0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Iron, bis(glycinato-.kappa.N,.kappa.O)-",20150-34-9,"No adverse effect seen. Iron will cause changes in blood parameters, but this is considered adaptive.  ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8624aef2-92f5-4d17-824d-6d3d338ad064/documents/b1f63de3-052e-4371-b9cc-96255f585643_b773fbf8-fde6-4882-9ff1-9139eba0290e.html,,,,,, "Iron, bis(glycinato-.kappa.N,.kappa.O)-",20150-34-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8624aef2-92f5-4d17-824d-6d3d338ad064/documents/b1f63de3-052e-4371-b9cc-96255f585643_b773fbf8-fde6-4882-9ff1-9139eba0290e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"ca.1,000 mg/kg bw/day",,rat "Iron, bis(glycinato-.kappa.N,.kappa.O)-",20150-34-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8624aef2-92f5-4d17-824d-6d3d338ad064/documents/50c697a8-21af-432c-914c-7254319eb952_b773fbf8-fde6-4882-9ff1-9139eba0290e.html,,oral,LD50,"> 2,000 mg/kg bw",adverse effect observed, "Iron, bis(glycinato-.kappa.N,.kappa.O)-",20150-34-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8624aef2-92f5-4d17-824d-6d3d338ad064/documents/50c697a8-21af-432c-914c-7254319eb952_b773fbf8-fde6-4882-9ff1-9139eba0290e.html,,dermal,LD50,"> 2,000 mg/kg bw",adverse effect observed, Iron sulphate,7720-78-7,"- Repeated dose toxicity, oral: • FeCl3: no classification, NOAEL = 277 mg/kg bw/d, LOAEL = 554 mg/kg bw/d, 1 study (probably comparable to OECD TG 408) • Fe2(SO4)3: no classification, no studies available, accordingly read across is used from FeCl3: NOAEL = 277 mg/kg bw/d * (399.88 g/mol/2 * 162.21 g/mol) = 341.4 mg/kg bw/d, LOAEL = 683 mg/kg bw/d • FeCl2: no classification (as treatment period was at least 42 d and dosed 7 d/week), NOAEL = 125 mg/kg bw, LOAEL: 250 mg/kg bw, 1 study (compliant to OECD TG 422 and GLP • FeSO4: no classification (effects at 163.9 mg/kg bw/d not sufficient for classification), NOAEL = 54.6 mg/kg bw, LOAEL = 163.9 mg/kg bw/d for anhydrous FeSO4, 1 study (compliant to OECD TG 422 and GLP) • FeClSO4: no classification, no studies available, accordingly read across is used from FeCl3: NOAEL = 277 mg/kg bw/d * (187.36 g/mol/62.21 g/mol) = 319.9 mg/kg bw/d, LOAEL = 639.9 mg/kg bw/d- Repeated dose toxicity, dermal: no studies available- Repeated dose toxicity, inhalation: • FeCl3: one reliable but not sufficient conclusive for classification study in rabbits reported a LOAEL of 1.4 mg Fe/m³, when exposed to FeCl3 aerosol ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21a7d91c-62ed-4d5c-87c1-0dd6db406d82/documents/IUC5-307403e6-2a34-4db0-951a-7d87d91c5adc_3c50054e-560b-4991-ab96-a39281940a54.html,,,,,, Iron sulphate,7720-78-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21a7d91c-62ed-4d5c-87c1-0dd6db406d82/documents/IUC5-307403e6-2a34-4db0-951a-7d87d91c5adc_3c50054e-560b-4991-ab96-a39281940a54.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Iron sulphate,7720-78-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21a7d91c-62ed-4d5c-87c1-0dd6db406d82/documents/IUC5-307403e6-2a34-4db0-951a-7d87d91c5adc_3c50054e-560b-4991-ab96-a39281940a54.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1.4 mg/m3,adverse effect observed,rabbit Iron sulphate,7720-78-7,"Acute toxicity, oral: H302: Harmful if swallowed, Category 4, OECD TG 423; study Choi 2005Acute toxicity, inhalation: No adverse effect observed in limit study, EPA OPP 81-3; US EPA 1993/Robbins 1991Acute toxicity, dermal: Non-toxic, OECD TG 402; study Choi 2004 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21a7d91c-62ed-4d5c-87c1-0dd6db406d82/documents/IUC5-3a1692e2-cd7b-4a46-bbad-912a529f86ba_3c50054e-560b-4991-ab96-a39281940a54.html,,,,,, Iron sulphate,7720-78-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21a7d91c-62ed-4d5c-87c1-0dd6db406d82/documents/IUC5-3a1692e2-cd7b-4a46-bbad-912a529f86ba_3c50054e-560b-4991-ab96-a39281940a54.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Iron sulphate,7720-78-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21a7d91c-62ed-4d5c-87c1-0dd6db406d82/documents/IUC5-3a1692e2-cd7b-4a46-bbad-912a529f86ba_3c50054e-560b-4991-ab96-a39281940a54.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Iron sulphate,7720-78-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21a7d91c-62ed-4d5c-87c1-0dd6db406d82/documents/IUC5-3a1692e2-cd7b-4a46-bbad-912a529f86ba_3c50054e-560b-4991-ab96-a39281940a54.html,,inhalation,discriminating conc.,"1,100 mg/m3",no adverse effect observed, 4-hydroxy-3-methoxycinnamic acid,1135-24-6," Two studies are available to evaluate the repeated doses toxicity of ferulic acid by oral route. In a study (Hirose et al 1987), the effects of naturally occurring antioxidants including ferulic acid on rat forestomach epithelium were compared with those of synthetic antioxidants, butylatedhydroxyanisole (BHA) and butylated hydroxytoluene (BHT), of which the former is a known forestomach carcinogen. Groups of five F344 male rats were given diet containing BHA, BHT, gallic acid, syringic acid, sesamol, caffeic acid, chlorogenic acid, ferulic acid, eugenol or esculin for 4 weeks at a level of 0.7% for BHT or 2% for the other compounds. Thus following an exposure of 4 weeks of 2% ferulic acid in diet, no effect was observed. The NOAEL was therefore determined to be 2000 mg/kg bw/day or higher for effect on forestomach (corresponding to the 2% ferulic acid in diet).   The second study (Tanaka et al 1993), was initially performed to investigate the protective effect of the plant phenolic antioxidants caffeic acid , ellagic acid ,chlorogenic acid and ferulic acid on the induction of tongue carcinogenesis induced by 4-NQO (4-nitroquinoline-l-oxide). However, this study was useful to assessment the repeated dose toxicity since Ferulic acid was administrated alone during 7 weeks at 500 ppm in diet. After these7 weeks, Ferulic acid did not show change in body, liver and relative livers weight. In addition, no tongue neoplasms and no pre-neoplastic lesions of the tongue were observed. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b4e9539-d506-4099-ae55-8af2be3957e7/documents/c9c954cd-b6a2-4ddc-8356-e5d216c443c7_b92fa115-c78e-4ee0-9c90-b8dc4aac4d5f.html,,,,,, Fluoren-9-one,486-25-9,"In an oral screening study for reproductive and developmental effects in rats, performed according to OECD guideline 422 and following GLP principles,  the systemic NOAEL for the parent animals for test material were derived to be 25 mg/kg bw/day, based on the adverse effects observed in clinical signs and decreased body weights and/or body weight gain and food consumption at 75 and 225 mg/kg bw/day for the parental animals. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1c785f6-ccad-4def-a234-af80961354cc/documents/32ca4984-06f5-4e29-953d-fcbbb9dd733a_25ad47c9-d517-4712-9cec-f2f179868b29.html,,,,,, Fluoren-9-one,486-25-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1c785f6-ccad-4def-a234-af80961354cc/documents/32ca4984-06f5-4e29-953d-fcbbb9dd733a_25ad47c9-d517-4712-9cec-f2f179868b29.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Fluoren-9-one,486-25-9,"Two acute toxicity studies are available, one with the substance and one with with related structural analugue ""fluorenone derivatives"", are provided as a weight-of-evidence. A combined in vivo Micronucleus/ Comet assay rats in accordance with OECD 489 and OECD 474 and according to GLP principles was considered appropriate to conclude on the acute oral toxicity of the substance. Therefore, the LD50 in rats was considered to exceed 2000 mg/kg bw/day. In a publication of an acute i.p. study with related structural analugue ""fluorenone derivatives"" the LD50 in mice after i.p. adinistration was determined to exceed 2000 mg/kg bw/day. No acute inhalation study was performed because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The substance has low vapour pressure (0.0091 Pa at 25°C) and a particle size of D90=2800 μm, D50= 1800 μm, D10= 1000 μm. No acute dermal study was performed because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and the substance is not irritating to the skin or a skin sensitizer. Skin corrosion, irritation and sensitization has been tested with in vitro methods. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1c785f6-ccad-4def-a234-af80961354cc/documents/c351e2ab-fa28-4603-bd71-e42d2ce413da_25ad47c9-d517-4712-9cec-f2f179868b29.html,,,,,, Fluoren-9-one,486-25-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1c785f6-ccad-4def-a234-af80961354cc/documents/c351e2ab-fa28-4603-bd71-e42d2ce413da_25ad47c9-d517-4712-9cec-f2f179868b29.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Disodium 4,4'-bis[[4-anilino-6-[(2-carbamoylethyl)(2-hydroxyethyl)amino]-1,3,5,-triazin-2-yl]amino]stilbene-2,2'-disulphonate",27344-06-5, NOAEL in male rats is 250 mg/kg bw/day (based on a study on OB 3b-A according to OECD guideline 422) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a900b98a-a7ca-4a00-97a8-61ef948eddbb/documents/18e22b90-0979-406a-b865-2fffa10d4cd5_ac4e3037-b696-407e-a65f-56128494e41b.html,,,,,, "Disodium 4,4'-bis[[4-anilino-6-[(2-carbamoylethyl)(2-hydroxyethyl)amino]-1,3,5,-triazin-2-yl]amino]stilbene-2,2'-disulphonate",27344-06-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a900b98a-a7ca-4a00-97a8-61ef948eddbb/documents/18e22b90-0979-406a-b865-2fffa10d4cd5_ac4e3037-b696-407e-a65f-56128494e41b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Disodium 4,4'-bis[[4-anilino-6-[(2-carbamoylethyl)(2-hydroxyethyl)amino]-1,3,5,-triazin-2-yl]amino]stilbene-2,2'-disulphonate",27344-06-5, Rat oral LD50 > 5000 mg/kg bw Rat inhalation LC50 > 1895 mg/m3 Rat dermal LD50 > 5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a900b98a-a7ca-4a00-97a8-61ef948eddbb/documents/IUC5-cce4a529-fac7-475d-b5ab-acc128f046eb_ac4e3037-b696-407e-a65f-56128494e41b.html,,,,,, "Disodium 4,4'-bis[[4-anilino-6-[(2-carbamoylethyl)(2-hydroxyethyl)amino]-1,3,5,-triazin-2-yl]amino]stilbene-2,2'-disulphonate",27344-06-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a900b98a-a7ca-4a00-97a8-61ef948eddbb/documents/IUC5-cce4a529-fac7-475d-b5ab-acc128f046eb_ac4e3037-b696-407e-a65f-56128494e41b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Disodium 4,4'-bis[[4-anilino-6-[(2-carbamoylethyl)(2-hydroxyethyl)amino]-1,3,5,-triazin-2-yl]amino]stilbene-2,2'-disulphonate",27344-06-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a900b98a-a7ca-4a00-97a8-61ef948eddbb/documents/IUC5-cce4a529-fac7-475d-b5ab-acc128f046eb_ac4e3037-b696-407e-a65f-56128494e41b.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Disodium 4,4'-bis[[4-anilino-6-[(2-carbamoylethyl)(2-hydroxyethyl)amino]-1,3,5,-triazin-2-yl]amino]stilbene-2,2'-disulphonate",27344-06-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a900b98a-a7ca-4a00-97a8-61ef948eddbb/documents/IUC5-cce4a529-fac7-475d-b5ab-acc128f046eb_ac4e3037-b696-407e-a65f-56128494e41b.html,,inhalation,LC50,"1,895 mg/m3",no adverse effect observed, "2,2'-(naphthalene-1,4-diyl)bis(benzoxazole)",5089-22-5, Oral LD50 (female) > 15000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7de9609-ddb4-4d03-b2e6-d67850243d55/documents/069d935d-4c6e-4c02-a016-9abe41cf3336_355f2f62-3ae6-4c78-ab04-9a1fe2cadd73.html,,,,,, "2,2'-(naphthalene-1,4-diyl)bis(benzoxazole)",5089-22-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7de9609-ddb4-4d03-b2e6-d67850243d55/documents/069d935d-4c6e-4c02-a016-9abe41cf3336_355f2f62-3ae6-4c78-ab04-9a1fe2cadd73.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "2,2'-(vinylenedi-p-phenylene)bisbenzoxazole",1533-45-5, NOAEL was in the dose range of 190-800 mg/kg bw for test chemical when exposed orally to rodent . ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee351814-827a-4c65-aae4-8e5661f5ad1a/documents/5615034d-06dd-4be4-9c8f-be52074af04f_865804ae-c209-407b-919a-9781a961af23.html,,,,,, "2,2'-(vinylenedi-p-phenylene)bisbenzoxazole",1533-45-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee351814-827a-4c65-aae4-8e5661f5ad1a/documents/5615034d-06dd-4be4-9c8f-be52074af04f_865804ae-c209-407b-919a-9781a961af23.html,Chronic toxicity – systemic effects,oral,NOAEL,800 mg/kg bw/day,,mouse "2,2'-(vinylenedi-p-phenylene)bisbenzoxazole",1533-45-5," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The given test chemical has very low vapour pressure (1.71E-11 Pa =1.2826052946961e-13 mmHg). So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver. Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee351814-827a-4c65-aae4-8e5661f5ad1a/documents/c25039bc-478c-4df1-87a5-f16524125ed1_865804ae-c209-407b-919a-9781a961af23.html,,,,,, "2,2'-(vinylenedi-p-phenylene)bisbenzoxazole",1533-45-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee351814-827a-4c65-aae4-8e5661f5ad1a/documents/c25039bc-478c-4df1-87a5-f16524125ed1_865804ae-c209-407b-919a-9781a961af23.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2'-(vinylenedi-p-phenylene)bisbenzoxazole",1533-45-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee351814-827a-4c65-aae4-8e5661f5ad1a/documents/c25039bc-478c-4df1-87a5-f16524125ed1_865804ae-c209-407b-919a-9781a961af23.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Formaldehyde,50-00-0,"There is evidence that formaldehyde induces toxic effects only at the site of contact after oral, dermal or inhalation exposure. Toxicity is not evident at remote sites such that general signs of toxicity occur only secondary to these local lesions. In spite of some recent studies describing effects after inhalation of formaldehyde far of the portal of entry, this assessment is still upheld after comparing these studies with key guideline studies of high validity.In chronic drinking water studies in rats local effects in the forestomach and stomach were induced, the NOAEC is 0.020-0.026% formaldehyde in drinking water. The NOAEL for systemic effects is 82 mg/kg bw/day in males and 109 mg/kg bw/day in females.Studies on repeated dermal dose toxicity in compliance to current Guidelines are not available.Local effects in the upper respiratory tract were induced after repeated inhalation exposure in experimental animals. The most sensitive site in rodents and monkeys following inhalation exposure is the respiratory epithelium in the anterior part of the nasal cavity. At higher exposure levels also the olfactory epithelium, larynx or trachea were affected. Rats are more sensitive than mice or hamsters. The LOAEC is 2 ppm in rats, 3 ppm in monkeys and 6 ppm in mice. The overall NOAEC for local effects in experimental animals is 1 ppm (1.2 mg/m³). The NOAEC for systemic effects not occurring at the site of first contact in long-term inhalation studies in rats and mice is 15 ppm. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): similar to OECD TG 453, K1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb43878b-ef6e-4cce-98ef-4f2139c2a795/documents/fd9e3bd7-96a4-46cc-b528-5e99f0264c27_416706e9-5a74-4eca-a396-1435c355f775.html,,,,,, Formaldehyde,50-00-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb43878b-ef6e-4cce-98ef-4f2139c2a795/documents/fd9e3bd7-96a4-46cc-b528-5e99f0264c27_416706e9-5a74-4eca-a396-1435c355f775.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,1.2 mg/m3,, Formaldehyde,50-00-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb43878b-ef6e-4cce-98ef-4f2139c2a795/documents/fd9e3bd7-96a4-46cc-b528-5e99f0264c27_416706e9-5a74-4eca-a396-1435c355f775.html,Chronic toxicity – systemic effects,oral,NOAEL,82 mg/kg bw/day,,rat Formaldehyde,50-00-0,"LD50(oral, rat) = 640 mg/kg bw (similar to OECD TG 401, non-GLP) LC50(inhalation, rat, 4h) < 463 ppm (OECD TG 403, GLP), local effects LD50(dermal) no data available, but not required as formaldehyde has corrosive properties. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): similar to OECD TG 401, non-GLP, K2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): OECD TG 403, GLP, K1 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb43878b-ef6e-4cce-98ef-4f2139c2a795/documents/815cfb2f-9703-47c5-8dda-847e719e752d_416706e9-5a74-4eca-a396-1435c355f775.html,,,,,, Formaldehyde,50-00-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb43878b-ef6e-4cce-98ef-4f2139c2a795/documents/815cfb2f-9703-47c5-8dda-847e719e752d_416706e9-5a74-4eca-a396-1435c355f775.html,,oral,LD50,640 mg/kg bw,adverse effect observed, Formaldehyde,50-00-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb43878b-ef6e-4cce-98ef-4f2139c2a795/documents/815cfb2f-9703-47c5-8dda-847e719e752d_416706e9-5a74-4eca-a396-1435c355f775.html,,inhalation,LC50,< 463 ,adverse effect observed, (ethoxymethoxy)cyclododecane,58567-11-6,NOAEL (oral) = 1000 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc8fa8bc-9113-4ccf-ac10-309cdaa089ac/documents/IUC5-ab0d2105-7f13-4334-97af-72343f56edbb_ece25cf7-b9fb-433d-97df-d54a79565e4d.html,,,,,, (ethoxymethoxy)cyclododecane,58567-11-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc8fa8bc-9113-4ccf-ac10-309cdaa089ac/documents/IUC5-ab0d2105-7f13-4334-97af-72343f56edbb_ece25cf7-b9fb-433d-97df-d54a79565e4d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat (ethoxymethoxy)cyclododecane,58567-11-6,"Oral (OECD 401), rat: LD50 > 5000 mg/kg body weight leading to not classification according to GLPDermal (OECD 402), rat: LD50 > 5000 mg/kg body weight leading to not classification according to GLPInhalation: no information available ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc8fa8bc-9113-4ccf-ac10-309cdaa089ac/documents/IUC5-5a58b29c-cd54-4457-af5e-daf1979bc379_ece25cf7-b9fb-433d-97df-d54a79565e4d.html,,,,,, Aminoiminomethanesulphinic acid,1758-73-2," Repeated dose toxicity oral: NOAEL (m, f): 20 mg/kg bw/day (OECD 422, GLP) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c8c6f30-6fe5-480d-a477-c08195921b24/documents/c13d4b3a-95f0-4ad7-b434-b1e96c4c8e31_01b7ff4f-1a14-45aa-8e7c-2734dc4b5d78.html,,,,,, Aminoiminomethanesulphinic acid,1758-73-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c8c6f30-6fe5-480d-a477-c08195921b24/documents/c13d4b3a-95f0-4ad7-b434-b1e96c4c8e31_01b7ff4f-1a14-45aa-8e7c-2734dc4b5d78.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat Aminoiminomethanesulphinic acid,1758-73-2, The acute toxicity tests in rats resulted in LD50= 1531 mg/kg bw for the oral toxicity of the solid substance LC50 = 0.168 mg/L for the respirable fraction of the substance ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c8c6f30-6fe5-480d-a477-c08195921b24/documents/1836f59e-57ab-48fc-8a80-9dac38e64431_01b7ff4f-1a14-45aa-8e7c-2734dc4b5d78.html,,,,,, Aminoiminomethanesulphinic acid,1758-73-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c8c6f30-6fe5-480d-a477-c08195921b24/documents/1836f59e-57ab-48fc-8a80-9dac38e64431_01b7ff4f-1a14-45aa-8e7c-2734dc4b5d78.html,,oral,LD50,"1,531 mg/kg bw",adverse effect observed, Aminoiminomethanesulphinic acid,1758-73-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c8c6f30-6fe5-480d-a477-c08195921b24/documents/1836f59e-57ab-48fc-8a80-9dac38e64431_01b7ff4f-1a14-45aa-8e7c-2734dc4b5d78.html,,inhalation,LC50,168 mg/m3,adverse effect observed, Formic acid,64-18-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/81fbf4b3-2d7f-42f6-9d07-8abecfe70f21/documents/IUC5-0429f9a8-49eb-4e58-92b5-0d8cd09a12ba_0f902ef0-b2cd-4d08-b7d0-3cff6622d989.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,122 mg/m3,,rat Formic acid,64-18-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/81fbf4b3-2d7f-42f6-9d07-8abecfe70f21/documents/IUC5-0429f9a8-49eb-4e58-92b5-0d8cd09a12ba_0f902ef0-b2cd-4d08-b7d0-3cff6622d989.html,Chronic toxicity – systemic effects,oral,NOAEL,142 mg/kg bw/day,,rat Formic acid,64-18-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81fbf4b3-2d7f-42f6-9d07-8abecfe70f21/documents/IUC5-d90c5e13-9403-4030-b2df-809f8b651805_0f902ef0-b2cd-4d08-b7d0-3cff6622d989.html,,oral,LD50,730 mg/kg bw,, Formic acid,64-18-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81fbf4b3-2d7f-42f6-9d07-8abecfe70f21/documents/IUC5-d90c5e13-9403-4030-b2df-809f8b651805_0f902ef0-b2cd-4d08-b7d0-3cff6622d989.html,,inhalation,LC50,"7,850 mg/m3",, 7-hydroxy-3-(4-methoxyphenyl)-4-benzopyrone,485-72-3, Formononetin is not considered to be acutely harmful by the oral or dermal routes. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f36ad4c-f290-4323-9d65-2ef7a7d2ac36/documents/348dfcd2-68ad-4b45-ae02-fcd05f65095f_55463744-8d4d-4068-b550-730b6b76b72c.html,,,,,, 7-hydroxy-3-(4-methoxyphenyl)-4-benzopyrone,485-72-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f36ad4c-f290-4323-9d65-2ef7a7d2ac36/documents/348dfcd2-68ad-4b45-ae02-fcd05f65095f_55463744-8d4d-4068-b550-730b6b76b72c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 7-hydroxy-3-(4-methoxyphenyl)-4-benzopyrone,485-72-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f36ad4c-f290-4323-9d65-2ef7a7d2ac36/documents/348dfcd2-68ad-4b45-ae02-fcd05f65095f_55463744-8d4d-4068-b550-730b6b76b72c.html,,dermal,LD50,"5,050 mg/kg bw",no adverse effect observed, 4-morpholinecarbaldehyde,4394-85-8," oral (OECD 407): NOAEL = 1000 mg/kgbw [BASF, 1998] inhalation (OECD 413): NOAECsystemic= 1000 mg/m3 & LOAEClocal= 100 mg/m3[BASF, 2016] No Observed Adverse Effect Concentration (NOAEC) could not be established due to local effects in nasal cavity ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b31a145-d1c4-4c69-96e1-10874627c813/documents/0a1a167a-d47d-44aa-bbcd-3cc950be3359_60c9a3bd-3c34-4246-9ead-34528909b6b0.html,,,,,, 4-morpholinecarbaldehyde,4394-85-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b31a145-d1c4-4c69-96e1-10874627c813/documents/0a1a167a-d47d-44aa-bbcd-3cc950be3359_60c9a3bd-3c34-4246-9ead-34528909b6b0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-morpholinecarbaldehyde,4394-85-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b31a145-d1c4-4c69-96e1-10874627c813/documents/0a1a167a-d47d-44aa-bbcd-3cc950be3359_60c9a3bd-3c34-4246-9ead-34528909b6b0.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat 4-morpholinecarbaldehyde,4394-85-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b31a145-d1c4-4c69-96e1-10874627c813/documents/0a1a167a-d47d-44aa-bbcd-3cc950be3359_60c9a3bd-3c34-4246-9ead-34528909b6b0.html,Repeated dose toxicity – local effects,inhalation,LOAEC,100 mg/m3,adverse effect observed,rat 4-morpholinecarbaldehyde,4394-85-8, The LD50 value derived from the key oral acute toxicity study on rats with N-formylmorpholine was > 7314 mg/kg bw. The dermal LD50 was > 18400 mg/kg bw for New Zealand White rabbits. The LC50 value was > 5.3 mg/l in male and female rats after 4 hour inhalation to liquid aerosol of the test-substance without any signs of mortality. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b31a145-d1c4-4c69-96e1-10874627c813/documents/1b88f5b9-6d1d-4830-ae3d-1e3f0b8786ee_60c9a3bd-3c34-4246-9ead-34528909b6b0.html,,,,,, 4-morpholinecarbaldehyde,4394-85-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b31a145-d1c4-4c69-96e1-10874627c813/documents/1b88f5b9-6d1d-4830-ae3d-1e3f0b8786ee_60c9a3bd-3c34-4246-9ead-34528909b6b0.html,,oral,discriminating dose,"7,314 mg/kg bw",no adverse effect observed, 4-morpholinecarbaldehyde,4394-85-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b31a145-d1c4-4c69-96e1-10874627c813/documents/1b88f5b9-6d1d-4830-ae3d-1e3f0b8786ee_60c9a3bd-3c34-4246-9ead-34528909b6b0.html,,dermal,discriminating dose,"18,400 mg/kg bw",no adverse effect observed, 4-morpholinecarbaldehyde,4394-85-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b31a145-d1c4-4c69-96e1-10874627c813/documents/1b88f5b9-6d1d-4830-ae3d-1e3f0b8786ee_60c9a3bd-3c34-4246-9ead-34528909b6b0.html,,inhalation,LC50,"5,319 mg/m3",no adverse effect observed, Fumaric acid,110-17-8," Two older studies comparable to OECD guideline 452 showed no signs of toxic effects in rats administered fumaric acid at dietary concentrations of up to 1.2 % for one or two years. The NOAEL for systemic toxicity was estimated as 1.2 % fumaric acid, or 600 mg/kg bw/d. The worst-case risk associated with subchronic dermal toxicity and subchronic inhalation toxicity of fumaric acid can be assessed using the results of chronic oral studies and additional testing cannot be justified either scientifically or in terms of animal welfare. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/beecc871-2ddf-46c0-b6f4-d4df2f496587/documents/IUC5-28c2fc38-509b-4efd-a160-ad7010360828_9e95d7c6-5a29-4f12-9469-e35f4cca83eb.html,,,,,, Fumaric acid,110-17-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/beecc871-2ddf-46c0-b6f4-d4df2f496587/documents/IUC5-28c2fc38-509b-4efd-a160-ad7010360828_9e95d7c6-5a29-4f12-9469-e35f4cca83eb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,, Fumaric acid,110-17-8," Fumaric acid was practically nontoxic when tested in guideline-comparable studies of acute oral and acute dermal toxicity. Inhalation testing is not required since a non-toxic response can be predicted based on the absence of inhalation exposure since the granulometry test confirms virtually no particles within the rat respirable range (< 6 % of particles are respirable i.e. < 10 micron). However, since human exposure via inhalation of a larger range of particles may be considered a possibility, an inhalation study was completed in rats at the maximum practical atmosphere concentration. 1.3 mg/L resulted in no adverse effects of inhalation exposure and confirmed the theoretical predictions. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/beecc871-2ddf-46c0-b6f4-d4df2f496587/documents/IUC5-42945056-b078-4945-a13e-e8b367c97618_9e95d7c6-5a29-4f12-9469-e35f4cca83eb.html,,,,,, Fumaric acid,110-17-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/beecc871-2ddf-46c0-b6f4-d4df2f496587/documents/IUC5-42945056-b078-4945-a13e-e8b367c97618_9e95d7c6-5a29-4f12-9469-e35f4cca83eb.html,,oral,LD50,"10,700 mg/kg bw",, Fumaric acid,110-17-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/beecc871-2ddf-46c0-b6f4-d4df2f496587/documents/IUC5-42945056-b078-4945-a13e-e8b367c97618_9e95d7c6-5a29-4f12-9469-e35f4cca83eb.html,,dermal,LD50,"20,000 mg/kg bw",, Fumaric acid,110-17-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/beecc871-2ddf-46c0-b6f4-d4df2f496587/documents/IUC5-42945056-b078-4945-a13e-e8b367c97618_9e95d7c6-5a29-4f12-9469-e35f4cca83eb.html,,inhalation,LC50,"1,306 mg/m3",, 2-furaldehyde,98-01-1,"Repeated dose oral, inhalation and dermal toxicity studies with furfural in rats, mice or hamsters are available. Evidence of slight systemic toxicity was seen following oral exposure whilst following inhalation exposure the primary effect is irritation and tissue damage in the nasal region. The NOAEC for nasal irritation was 8 mg/m3. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be06696e-e377-4a75-bc95-051fdee01ed7/documents/5afd3c93-e505-4a23-afe5-507420229539_d25ab28c-cfba-48e8-965a-809bc0e58ed0.html,,,,,, 2-furaldehyde,98-01-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be06696e-e377-4a75-bc95-051fdee01ed7/documents/5afd3c93-e505-4a23-afe5-507420229539_d25ab28c-cfba-48e8-965a-809bc0e58ed0.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,320 mg/m3,,rat 2-furaldehyde,98-01-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be06696e-e377-4a75-bc95-051fdee01ed7/documents/5afd3c93-e505-4a23-afe5-507420229539_d25ab28c-cfba-48e8-965a-809bc0e58ed0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,53 mg/kg bw/day,,rat 2-furaldehyde,98-01-1,The key study reports the acute oral LD50 in the rat to be 100 mg/kg. A modern reliable dermal toxicity study reports a dermal LD50 value of >2000 mg/kg in rats. A clear NOAEC of 0.54 mg/L is reported for acute inhalation toxicity and the weight of evidence from several other studies indicates an acute inhalation 4 hour LC50 of approximately 1000 mg/m3 (1 mg/L). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be06696e-e377-4a75-bc95-051fdee01ed7/documents/3337560c-cd20-48d8-8d22-b0620ef8140c_d25ab28c-cfba-48e8-965a-809bc0e58ed0.html,,,,,, 2-furaldehyde,98-01-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be06696e-e377-4a75-bc95-051fdee01ed7/documents/3337560c-cd20-48d8-8d22-b0620ef8140c_d25ab28c-cfba-48e8-965a-809bc0e58ed0.html,,oral,LD50,100 mg/kg bw,, 2-furaldehyde,98-01-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be06696e-e377-4a75-bc95-051fdee01ed7/documents/3337560c-cd20-48d8-8d22-b0620ef8140c_d25ab28c-cfba-48e8-965a-809bc0e58ed0.html,,dermal,LD50,"2,001 mg/kg bw",, 2-furaldehyde,98-01-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be06696e-e377-4a75-bc95-051fdee01ed7/documents/3337560c-cd20-48d8-8d22-b0620ef8140c_d25ab28c-cfba-48e8-965a-809bc0e58ed0.html,,inhalation,LC50,"1,000 mg/m3",, Fusel oil,8013-75-0,"No toxicity after repeated exposure was observed with the main constituents of Fusel oil, being ethanol (CAS No. 64-17-5), 3-methylbutan-1-ol (CAS No. 123-51-3), 2-methylbutan-1-ol (CAS No. 137-32-6), and 2-methylpropan-1-ol (CAS No. 78-83-1). For all 4 substances the NOAELs were ≥ 1000 mg/kg bw/day after oral exposure. The minor constituents of Fusel oil have no influence on the toxicity after repeated exposure based on the absence of a hazard and their low concentration. The available data from the main constituents of Fusel oil indicate that Fusel oil is not toxic after repeated exposure. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0f81131-2ed4-4348-b144-d67d5638e565/documents/IUC5-d431d062-471e-409b-8bb9-69a2c8a6f8f4_0aa64ff4-197c-4157-853c-70562d66668e.html,,,,,, Fusel oil,8013-75-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0f81131-2ed4-4348-b144-d67d5638e565/documents/IUC5-d431d062-471e-409b-8bb9-69a2c8a6f8f4_0aa64ff4-197c-4157-853c-70562d66668e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,068 mg/kg bw/day",,rat Fusel oil,8013-75-0,"In conclusion, no acute toxicity hazard was observed with the main constituents of Fusel oil, being ethanol (CAS No. 64-17-5), 3-methylbutan-1-ol (CA 123-51-3), 2-methylbutan-1-ol (CAS No. 137-32-6), and 2-methylpropan-1-ol (CAS No. 78-83-1). The minor constituents of Fusel oil have no influence on the acute toxic properties. The available data from the main constituents of Fusel oil indicate that Fusel oil has no acute toxic properties, independent of the route of exposure. Based on the narcotic effects of 2-methylpropan-1-ol, Fusel oil is may also exhibit narcotic effects based on the composition. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0f81131-2ed4-4348-b144-d67d5638e565/documents/IUC5-3ed7e92a-8aa0-4c2d-8093-a776327cde4e_0aa64ff4-197c-4157-853c-70562d66668e.html,,,,,, "3,4,5-trihydroxybenzoic acid",149-91-7," Repeated dose toxicity tests have been peformed by oral route in 2 publications for 28 and 90 days with determination of NOAEL of 1000 mg/kg bw/d in 28-day test and NOAEL of 119 and 128 mg/kg bw/d, respectively for males and females, in 90-day test ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdaa4a1c-0c5f-4a32-8c16-233f2df7d0f8/documents/815cb3d4-b4d7-49e1-a1b3-0e89037537ef_b19064d7-5e1d-4bda-8cc3-fc68be5f2a07.html,,,,,, "3,4,5-trihydroxybenzoic acid",149-91-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdaa4a1c-0c5f-4a32-8c16-233f2df7d0f8/documents/815cb3d4-b4d7-49e1-a1b3-0e89037537ef_b19064d7-5e1d-4bda-8cc3-fc68be5f2a07.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,119 mg/kg bw/day,,rat Hexan-4-olide,695-06-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f06157c4-23c5-4c99-8b9f-bf925f280f3d/documents/2b7734ec-38de-4c63-a1d8-f16007408b4f_9fe4390e-ecd1-4051-95fb-6fafd440be16.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat Hexan-4-olide,695-06-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f06157c4-23c5-4c99-8b9f-bf925f280f3d/documents/97db558f-bd85-401e-801d-3d321d5a9992_9fe4390e-ecd1-4051-95fb-6fafd440be16.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Hexan-4-olide,695-06-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f06157c4-23c5-4c99-8b9f-bf925f280f3d/documents/97db558f-bd85-401e-801d-3d321d5a9992_9fe4390e-ecd1-4051-95fb-6fafd440be16.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Decan-4-olide,706-14-9,"Repeated dose toxicity oral: read-across on γ-Caprolactone, NOAEL = 1000 mg/kg bw/d (OECD 407, GLP, K, rel. 2) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b6390ef-5563-4a65-b0d8-f3b3f173d6d9/documents/IUC5-da381e91-5b79-4bac-a7e9-a56019b07ff6_63fbc19f-b819-4236-8cfe-66eedffe5d5b.html,,,,,, Decan-4-olide,706-14-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b6390ef-5563-4a65-b0d8-f3b3f173d6d9/documents/IUC5-da381e91-5b79-4bac-a7e9-a56019b07ff6_63fbc19f-b819-4236-8cfe-66eedffe5d5b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Decan-4-olide,706-14-9,- Acute toxicity: oral: LD50 > 2000 mg/kg bw (WoE)- Acute toxicity: dermal: LD50 > 2000 mg/kg bw/f (WoE)- Acute toxicity: inhalation: waiving ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b6390ef-5563-4a65-b0d8-f3b3f173d6d9/documents/IUC5-5fb1f3a2-24f8-4efa-ba31-1a8b61c51f5b_63fbc19f-b819-4236-8cfe-66eedffe5d5b.html,,,,,, Decan-4-olide,706-14-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b6390ef-5563-4a65-b0d8-f3b3f173d6d9/documents/IUC5-5fb1f3a2-24f8-4efa-ba31-1a8b61c51f5b_63fbc19f-b819-4236-8cfe-66eedffe5d5b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Decan-4-olide,706-14-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b6390ef-5563-4a65-b0d8-f3b3f173d6d9/documents/IUC5-5fb1f3a2-24f8-4efa-ba31-1a8b61c51f5b_63fbc19f-b819-4236-8cfe-66eedffe5d5b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dihydro-5-octylfuran-2(3H)-one,2305-05-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e9fec40-1e2e-421e-b85d-01cc4e72313f/documents/54f4de3d-9d5d-4678-a769-2881caed51db_6e37024f-46ce-41fe-ae55-5c4d90f6a778.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat Dihydro-5-octylfuran-2(3H)-one,2305-05-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e9fec40-1e2e-421e-b85d-01cc4e72313f/documents/4e40443a-ea54-4486-b227-cbf6e03405c3_6e37024f-46ce-41fe-ae55-5c4d90f6a778.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dihydro-5-octylfuran-2(3H)-one,2305-05-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e9fec40-1e2e-421e-b85d-01cc4e72313f/documents/4e40443a-ea54-4486-b227-cbf6e03405c3_6e37024f-46ce-41fe-ae55-5c4d90f6a778.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 5-hexyldihydro-5-methylfuran-2(3H)-one,7011-83-8,The acute dermal LD50 for rabbits was greater than 5000 mg/kg bw.The test substance had an acute oral LD50 greater than 5000 mg/kg bw in rats. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cac3c705-b301-403c-9d26-1127b62f4836/documents/IUC5-b563974c-aa10-40d8-b530-f9c4d00d44a3_799227e4-8a8f-45fd-a4dd-91a758fd1963.html,,,,,, 5-hexyldihydro-5-methylfuran-2(3H)-one,7011-83-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cac3c705-b301-403c-9d26-1127b62f4836/documents/IUC5-b563974c-aa10-40d8-b530-f9c4d00d44a3_799227e4-8a8f-45fd-a4dd-91a758fd1963.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, 5-hexyldihydro-5-methylfuran-2(3H)-one,7011-83-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cac3c705-b301-403c-9d26-1127b62f4836/documents/IUC5-b563974c-aa10-40d8-b530-f9c4d00d44a3_799227e4-8a8f-45fd-a4dd-91a758fd1963.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Nonan-4-olide,104-61-0,"Repeated dose toxicity oral: read-across on γ-Caprolactone, NOAEL = 1000 mg/kg bw/d (OECD 407, GLP, K, rel. 2) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b87bfeb6-79c8-4187-80fb-5d1b01575560/documents/IUC5-b3745cd9-50fa-4b2f-9136-6e87cd06d73f_60e106a8-631e-4e42-b307-8242821585cb.html,,,,,, Nonan-4-olide,104-61-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b87bfeb6-79c8-4187-80fb-5d1b01575560/documents/IUC5-b3745cd9-50fa-4b2f-9136-6e87cd06d73f_60e106a8-631e-4e42-b307-8242821585cb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Nonan-4-olide,104-61-0,"- Acute toxicity: oral: Males LD50 = 6600 mg/kg bw (eq. OECD 401, K, rel.2)- Acute toxicity: dermal: LD50 > 50000 mg/kg bw/d (WoE)- Acute toxicity: inhalation: waiving ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b87bfeb6-79c8-4187-80fb-5d1b01575560/documents/IUC5-4bc9cc76-b118-472e-8b47-640d014be737_60e106a8-631e-4e42-b307-8242821585cb.html,,,,,, Nonan-4-olide,104-61-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b87bfeb6-79c8-4187-80fb-5d1b01575560/documents/IUC5-4bc9cc76-b118-472e-8b47-640d014be737_60e106a8-631e-4e42-b307-8242821585cb.html,,oral,LD50,"6,600 mg/kg bw",no adverse effect observed, Nonan-4-olide,104-61-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b87bfeb6-79c8-4187-80fb-5d1b01575560/documents/IUC5-4bc9cc76-b118-472e-8b47-640d014be737_60e106a8-631e-4e42-b307-8242821585cb.html,,dermal,LD50,"50,000 ",no adverse effect observed, Octan-4-olide,104-50-7," Read-across to hexan-4-olide (CAS No. 695-06-7) - Repeated dose toxicity (oral, subacute): NOAEL = 1000 mg/kg bw/day (OECD 407/GLP) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0eca2f4-17d9-44f9-b594-3e2ce75e12d8/documents/11d3a0fa-5b29-4c11-950e-d129ad70539e_cacdb4eb-6f53-4a86-9813-35f299087fa7.html,,,,,, Octan-4-olide,104-50-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0eca2f4-17d9-44f9-b594-3e2ce75e12d8/documents/11d3a0fa-5b29-4c11-950e-d129ad70539e_cacdb4eb-6f53-4a86-9813-35f299087fa7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Octan-4-olide,104-50-7, Acute oral toxicity: LD50 > 5000 mg/kg bw (equivalent or similar to OECD 401) Acute dermal toxicity: LD50 > 5000 mg/kg bw (equivalent or similar to OECD 402) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0eca2f4-17d9-44f9-b594-3e2ce75e12d8/documents/2df68fb0-5344-419f-b684-1ced5edb1761_cacdb4eb-6f53-4a86-9813-35f299087fa7.html,,,,,, Octan-4-olide,104-50-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0eca2f4-17d9-44f9-b594-3e2ce75e12d8/documents/2df68fb0-5344-419f-b684-1ced5edb1761_cacdb4eb-6f53-4a86-9813-35f299087fa7.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Octan-4-olide,104-50-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0eca2f4-17d9-44f9-b594-3e2ce75e12d8/documents/2df68fb0-5344-419f-b684-1ced5edb1761_cacdb4eb-6f53-4a86-9813-35f299087fa7.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Undecan-4-olide,104-67-6," Repeated dose toxicity oral: read-across on γ-Caprolactone, NOAEL = 1000 mg/kg bw/d (OECD 407, GLP, K, rel. 2) Repeated dose toxicity oral: read-across on γ-Butyrolactone, NOAEL = 1050 and 900 mg/kg bw/d in mice and rats, respectively (OECD 408 GLP, K, rel. 2) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83f1e409-87c0-4fa1-b677-8e033f19446a/documents/IUC5-d30843f7-10a3-4156-8165-2b3841859d64_6f0e57c0-8cda-4307-8ebe-f626dd0bf44c.html,,,,,, Undecan-4-olide,104-67-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83f1e409-87c0-4fa1-b677-8e033f19446a/documents/IUC5-d30843f7-10a3-4156-8165-2b3841859d64_6f0e57c0-8cda-4307-8ebe-f626dd0bf44c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Undecan-4-olide,104-67-6," - Acute toxicity: oral: LD50 > 2000 mg/kg bw (WoE) - Acute toxicity: dermal: Combined LD50 > 2000 mg/kg bw (OECD 402, GLP, K, rel.1) - Acute toxicity: inhalation: waiving ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83f1e409-87c0-4fa1-b677-8e033f19446a/documents/IUC5-8c1ce589-2802-472d-8735-93980f1d9309_6f0e57c0-8cda-4307-8ebe-f626dd0bf44c.html,,,,,, Undecan-4-olide,104-67-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83f1e409-87c0-4fa1-b677-8e033f19446a/documents/IUC5-8c1ce589-2802-472d-8735-93980f1d9309_6f0e57c0-8cda-4307-8ebe-f626dd0bf44c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Undecan-4-olide,104-67-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83f1e409-87c0-4fa1-b677-8e033f19446a/documents/IUC5-8c1ce589-2802-472d-8735-93980f1d9309_6f0e57c0-8cda-4307-8ebe-f626dd0bf44c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, γ-valerolactone,108-29-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The subacute study is a guideline study (OECD422) conducted under GLP. The two subchronic studies are comparable to guideline studies with acceptable restrictions. None of the studies showed adverse effects at the doses tested. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b288832-8b64-4d10-9e07-0b9e63247871/documents/3b39db1c-eea3-4382-b3cf-b565a714f8f6_cce2b18c-644a-4357-b323-2c6d58491463.html,,,,,, γ-valerolactone,108-29-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b288832-8b64-4d10-9e07-0b9e63247871/documents/3b39db1c-eea3-4382-b3cf-b565a714f8f6_cce2b18c-644a-4357-b323-2c6d58491463.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat γ-valerolactone,108-29-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Study well documented, meets generally accepted scientific principles, acceptable for assessment Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Study well documented, meets generally accepted scientific principles, acceptable for assessment ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b288832-8b64-4d10-9e07-0b9e63247871/documents/e3b13072-af70-4eb5-8339-62909170e4fb_cce2b18c-644a-4357-b323-2c6d58491463.html,,,,,, γ-valerolactone,108-29-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b288832-8b64-4d10-9e07-0b9e63247871/documents/e3b13072-af70-4eb5-8339-62909170e4fb_cce2b18c-644a-4357-b323-2c6d58491463.html,,oral,LD50,"9,249 mg/kg bw",adverse effect observed, γ-valerolactone,108-29-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b288832-8b64-4d10-9e07-0b9e63247871/documents/e3b13072-af70-4eb5-8339-62909170e4fb_cce2b18c-644a-4357-b323-2c6d58491463.html,,dermal,discriminating dose,"> 2,102 mg/kg bw",no adverse effect observed, γ-valerolactone,108-29-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b288832-8b64-4d10-9e07-0b9e63247871/documents/e3b13072-af70-4eb5-8339-62909170e4fb_cce2b18c-644a-4357-b323-2c6d58491463.html,,inhalation,discriminating conc.,"> 10,000 mg/m3",adverse effect observed, Geraniol,106-24-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4a5be3e-ef38-4f39-b029-a49e450dc376/documents/IUC5-9ee18b5d-d6d4-4b20-a1a6-c2403e9f882f_80bd7b60-f743-4f4e-b4b9-384188f98402.html,,oral,LD50,"3,600 mg/kg bw",, Geraniol,106-24-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4a5be3e-ef38-4f39-b029-a49e450dc376/documents/IUC5-9ee18b5d-d6d4-4b20-a1a6-c2403e9f882f_80bd7b60-f743-4f4e-b4b9-384188f98402.html,,dermal,LD50,"5,000 mg/kg bw",, Geranyl acetate,105-87-3,"Acute toxicity:- oral: LD50 = 6330 mg/kg bw (Jenner 1964) - dermal: LD50 > 6 ml/kg bw (Levenstein, 1972) - Neryl acetate ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3585b0fe-51d2-4929-8ef9-747fc3f92000/documents/IUC5-c926b5a8-a285-41d9-81fb-d015fa41984b_ffc4ddc9-03f4-49dc-9eb0-9a5ddb6b0ec7.html,,,,,, Geranyl butyrate,106-29-6, Geranyl butyrate is likely to be non hazardous by oral and dermal route of exposure. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6e4c246-c067-4c27-a53b-2f3aad976d88/documents/IUC5-88f77edd-866a-4ce4-9bd3-a23bb2db737e_9199c388-5e8d-444b-b840-6cd586215ce1.html,,,,,, Geranyl butyrate,106-29-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6e4c246-c067-4c27-a53b-2f3aad976d88/documents/IUC5-88f77edd-866a-4ce4-9bd3-a23bb2db737e_9199c388-5e8d-444b-b840-6cd586215ce1.html,,oral,LD50,"10,660 mg/kg bw",no adverse effect observed, Geranyl butyrate,106-29-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6e4c246-c067-4c27-a53b-2f3aad976d88/documents/IUC5-88f77edd-866a-4ce4-9bd3-a23bb2db737e_9199c388-5e8d-444b-b840-6cd586215ce1.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Geranyl formate,105-86-2," Oral (OECD 401), rat: LD50 > 6 mL/kg bw (corresponding to > 5532 mg/kg bw based on a relative density of 0.922 g/cm³) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92da7b91-1763-4bb8-9580-ed7dc164d386/documents/526e33f0-e0ce-4e7d-95bd-f80a8df3edce_bc571c87-93b7-4048-be03-da226ec5678d.html,,,,,, Geranyl isobutyrate,2345-26-8," Acute oral toxicity LD50 was considered to be > 5000 mg/kg bw when rat were treated with 3,7-dimethylocta-2,6-dien-1-yl 2-methylpropanoate orally. Acute dermal toxicity LD50 was considered to be > 5000 mg/kg bw when rabbit were treated with 3,7-dimethylocta-2,6-dien-1-yl 2-methylpropanoate dermally. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e291c50c-6ceb-4fd1-b153-396bdc99baa6/documents/2832e5a0-5f08-4a70-80ed-eec500456b95_2e0824b5-cce9-4d07-bcd2-c360284de957.html,,,,,, Geranyl isobutyrate,2345-26-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e291c50c-6ceb-4fd1-b153-396bdc99baa6/documents/2832e5a0-5f08-4a70-80ed-eec500456b95_2e0824b5-cce9-4d07-bcd2-c360284de957.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Geranyl isobutyrate,2345-26-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e291c50c-6ceb-4fd1-b153-396bdc99baa6/documents/2832e5a0-5f08-4a70-80ed-eec500456b95_2e0824b5-cce9-4d07-bcd2-c360284de957.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Geranyl phenylacetate,102-22-7," Acute oral toxicity LD50 was estimated to be 4439.30mg/kg bw, when rats were exposed with Geranyl phenylacetate (102-22-7) orally. Acute dermal toxicity LD50 was estimated to be 6696.37mg/kg bw.When male and female New Zealand White rabbits were exposed with Geranyl phenylacetate (102-22-7) by dermal application. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc0eda01-3259-4a6f-88c9-61dd49c65f80/documents/c31e8af3-1519-421c-b86f-11de1f215e06_9c6f82d2-6a15-4d58-94e3-e2e7d0684139.html,,,,,, Geranyl phenylacetate,102-22-7,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc0eda01-3259-4a6f-88c9-61dd49c65f80/documents/c31e8af3-1519-421c-b86f-11de1f215e06_9c6f82d2-6a15-4d58-94e3-e2e7d0684139.html,,oral,LD50,"4,439.3 mg/kg bw",no adverse effect observed, Geranyl phenylacetate,102-22-7,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc0eda01-3259-4a6f-88c9-61dd49c65f80/documents/c31e8af3-1519-421c-b86f-11de1f215e06_9c6f82d2-6a15-4d58-94e3-e2e7d0684139.html,,dermal,LD50,"6,696.37 mg/kg bw",no adverse effect observed, Geranyl propionate,105-90-8," Acute oral toxicity:  LD50 was considered to be >5000 mg/kg bw, when rats were treated with 3,7-dimethylocta-2,6-dien-1-yl propanoate (105-90-8) orally. Acute Dermal toxicity:  LD50 was considered to be >5000 mg/kg bw, when rabbits were treated with 3,7-dimethylocta-2,6-dien-1-yl propanoate (105-90-8) by dermal application. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d85fbe9b-5d40-4b11-a19a-237a8abf2935/documents/81033e83-9f39-4f79-954c-767558772cd2_4df8dc08-6f6f-4a4d-b723-04dc2316df8b.html,,,,,, Geranyl propionate,105-90-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d85fbe9b-5d40-4b11-a19a-237a8abf2935/documents/81033e83-9f39-4f79-954c-767558772cd2_4df8dc08-6f6f-4a4d-b723-04dc2316df8b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Geranyl propionate,105-90-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d85fbe9b-5d40-4b11-a19a-237a8abf2935/documents/81033e83-9f39-4f79-954c-767558772cd2_4df8dc08-6f6f-4a4d-b723-04dc2316df8b.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Germanium dioxide,1310-53-8," Repeated dose oral toxicity: Animal repeated dose oral toxicity studies after exposure to GeO2 are demonstrating nephrotoxicity and myopathy. The study reporting the most sensitive (most relevant) data point (Sanai et al., 1991) was used: LOAEL= 0.0375g/kg BW/d inducing systemic toxicity by weight loss, anemia, and hypo-proteinemia and renal dysfunction (indicated by the increase of blood urea nitrogen and the decrease of creatinine clearance). In this 24-week feeding study, a a dose-dependent effect of GeO2 is demonstrated in rats. The lowest LOAEL, which was reported by Yim et al., 1999 (0.01g/kg BW/d), was not retained for further assessment since this effect concentration was solely based on the subcellular effects mitochondrial myopathia. Repeated dose inhalation toxicity: 28d repeated dose inhalation (Arts et al., 1994): In a guideline study, conducted to GLP, administration of rats to Germanium dioxide by inhalation 6h/d and 5d/wk for 4wk at doses of 0,16, 72, or 309 mg/m3, had adverse effects at the highest dose especially on growth, kidneys and liver. A NOAEL of 72mg/m3 was established. Repeated dose dermal toxicity: No repeated dose toxicity study by the dermal route were identified. Testing by the dermal route has been waived. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9871fe25-3589-41ae-82e2-07bc8cf454a5/documents/98a505ff-97f0-45bf-95f5-c99d5114cd16_8c12449e-f124-4744-b4ec-0995dfecb8b9.html,,,,,, Germanium dioxide,1310-53-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9871fe25-3589-41ae-82e2-07bc8cf454a5/documents/98a505ff-97f0-45bf-95f5-c99d5114cd16_8c12449e-f124-4744-b4ec-0995dfecb8b9.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,72 mg/m3,,rat Germanium dioxide,1310-53-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9871fe25-3589-41ae-82e2-07bc8cf454a5/documents/98a505ff-97f0-45bf-95f5-c99d5114cd16_8c12449e-f124-4744-b4ec-0995dfecb8b9.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,37.5 mg/kg bw/day,,rat Germanium dioxide,1310-53-8," Assessment of the acute oral toxicity of germanium dioxide in Arulnesan et al 2012: An Acute Oral Toxicity Study of Germanium Dioxide, was carried out according to OECD 425. The test item was suspended in 1% methyl cellulose at a concentration of 200 mg/mL. The first animal was dosed at 2000 mg/kg at a dose volume of 10.0 mL/kg. Since this first animal survived, four additional animals were dosed at 2-day intervals. A total of 5 female CD (Sprague-Dawley) rats were dosed. All animals received the test item by oral gavage using a feeding cannula inserted into the stomach of the animals. The animals were observed for a 14-day period after dosing. Body weights were recorded prior to test item administration (i.e., Day 0), on Day 7 and prior to necropsy on Day 14. No mortalities were observed post dosing and during the 14-day observation period in any of the animals. All rats gained body weight by Day 7 and at the end of the study. At the end of the 14-day observation period, each animal was sacrificed and submitted for gross necropsy. No gross pathological findings were observed in any of the rats at necropsy. Based on the foregoing results, the acute oral LD50 in rats of the test item, Germanium Dioxide, was found to be in excess of 2000 mg/kg. Therefore, the test item is considered not to present a significant acute toxic risk if swallowed. Assessment of the acute inhalation toxicity of germanium dioxide in Arts et al 1994: The acute (4 -hour) inhalation toxicity of amorphous and hexagonal germanium dioxide was studied by exposing total-body one group of rats, consisting of five male and five female rats, to a test atmosphere containing amorphous germanium dioxide and hexagonal germanium dioxide at maximum attainable concentrations of 3.10 and 1.42 g/m3 in air respectively for one single time for a period of 4 hours. It was concluded that the 4 hours LC50 value of amorphous germanium dioxide was higher than 3.10g/m3 and that the 4 hours LC50 value of hexagonal germanium dioxide was higher than 1.42g/m3. In addition, a dustiness test on dust fractions of 1g GeO2 is performed.  It can be concluded from this dustiness test that the tested sample is showing little dustiness with very small dustiness values for the alveolar fraction.  Therefore, it can be concluded that the LC 50 > 3.10 g/m3 and > 1.42 g/m3 (maximum attainable concentration) implicates LC 50 > 5 g/m3 indicating GHS criteria not met for classification (reference: Final - Report on the determination of the dust generation tendency (“dustiness”) of germanium dioxide -  Report no. APS 2 00 007, 2017, DMT GmbH & Co. KG   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9871fe25-3589-41ae-82e2-07bc8cf454a5/documents/0b519e8c-545f-48d1-8e82-34ee6903408f_8c12449e-f124-4744-b4ec-0995dfecb8b9.html,,,,,, Germanium dioxide,1310-53-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9871fe25-3589-41ae-82e2-07bc8cf454a5/documents/0b519e8c-545f-48d1-8e82-34ee6903408f_8c12449e-f124-4744-b4ec-0995dfecb8b9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, D-gluconic acid,526-95-4,"Sprague Dawley (JCL:SD) rats were administered D-glucono-1,5-lactone (GDL) by oral gavage at daily doses of 0 (vehicle control), 250, 500, 1000, 2000, or 4000 mg/kg body weight for 6 months in a key, repeat-dose toxicity study. This non-GLP study was equivalent to OECD Test Guideline 408. A No-Observed-Adverse-Effect Level (NOAEL) was not identified by the authors, and one could not be determined as pathological effects in the stomach were observed in all dose-groups. However, these effects were considered not to be relevant to humans. Based on a review of the data, the Lowest-Observed-Adverse Effect Level (LOAEL) was determined to be 250 mg/kg body weight in rats. No supporting oral studies were located and no inhalation or dermal repeat-dose toxicity studies have been conducted. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7eb731a1-aa4e-4b72-8834-fbfb7df8ecc7/documents/98c0b723-5064-4fb5-bdc7-64694cba6ec3_2620d37f-3f98-430d-96e1-08bc073f7409.html,,,,,, D-gluconic acid,526-95-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7eb731a1-aa4e-4b72-8834-fbfb7df8ecc7/documents/98c0b723-5064-4fb5-bdc7-64694cba6ec3_2620d37f-3f98-430d-96e1-08bc073f7409.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,250 mg/kg bw/day,,rat D-gluconic acid,526-95-4,"Information on the acute oral toxicity of D-gluconic acid was obtained from data on the read across substance, potassium gluconate. Potassium gluconate is associated with low acute toxicity in rats following oral administration. The reported oral LD50 of potassium gluconate was 6060 mg/kg body weight in male and female Wistar rats in a study performed to test guidelines (Spanjers and Til, 1978). Transient clinical signs included sluggishness, humpback behaviour, and severe diarrhea and 7 out of 10 animals died at the high dose level of 6.21 g/kg bw between 5 and 21 hours after administration of the test article. There were no macroscopic findings at necropsy. Only 2 out of 10 animals died following application of 5.19 g/kg bw.   Information on the acute dermal toxicity effects of D-gluconic acid is available. Gluconic acid is associated with low acute toxicity following dermal administration in rats. The dermal LD50 value for gluconic acid was determined to be greater than 2000 mg/kg body weight in rats in a study performed according to test guidelines and good laboratory practice (Mortier, 2009). There were no mortalities, adverse clinical effects, body weight effects, dermal reactions, or adverse findings in organ or tissue at necropsy.   In accordance with column 2 of REACH Annex VIII, the acute toxicity by inhalation study (required in section 8.5.2) does not need to be conducted as acute toxicity studies are available for the oral and dermal routes of exposure and as inhalative exposure is unlikely. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7eb731a1-aa4e-4b72-8834-fbfb7df8ecc7/documents/39441d90-66c3-4ce1-8574-cf66e3b38969_2620d37f-3f98-430d-96e1-08bc073f7409.html,,,,,, D-gluconic acid,526-95-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7eb731a1-aa4e-4b72-8834-fbfb7df8ecc7/documents/39441d90-66c3-4ce1-8574-cf66e3b38969_2620d37f-3f98-430d-96e1-08bc073f7409.html,,oral,LD50,"6,060 mg/kg bw",no adverse effect observed, D-gluconic acid,526-95-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7eb731a1-aa4e-4b72-8834-fbfb7df8ecc7/documents/39441d90-66c3-4ce1-8574-cf66e3b38969_2620d37f-3f98-430d-96e1-08bc073f7409.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "D-glucono-1,5-lactone",90-80-2,"Sprague Dawley (JCL:SD) rats were administered D-glucono-1,5-lactone (GDL) by oral gavage at daily doses of 0 (vehicle control), 250, 500, 1000, 2000, or 4000 mg/kg body weight for 6 months in a key, repeat-dose toxicity study. This non-GLP study was equivalent to OECD Test Guideline 408. A No-Observed-Adverse-Effect Level (NOAEL) was not identified by the authors, and one could not be determined as pathological effects in the stomach were observed in all dose-groups. However, these effects were considered not to be relevant to humans. Based on a review of the data, the Lowest-Observed-Adverse Effect Level (LOAEL) was determined to be 250 mg/kg body weight in rats. No supporting oral studies were located, and no inhalation or dermal repeat-dose toxicity studies have been conducted. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25fbb925-35c9-46d1-a8c8-e8efe728ad1b/documents/f8a65439-efc3-41ea-b59d-f41a072ead5b_11bb642d-4842-4f8c-a7b0-c8baf97ae4da.html,,,,,, "D-glucono-1,5-lactone",90-80-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25fbb925-35c9-46d1-a8c8-e8efe728ad1b/documents/f8a65439-efc3-41ea-b59d-f41a072ead5b_11bb642d-4842-4f8c-a7b0-c8baf97ae4da.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,250 mg/kg bw/day,, "D-glucono-1,5-lactone",90-80-2,"Information on the acute oral toxicity of D-glucono-1,5-lactone was obtained from data on the read across substance, potassium gluconate. Potassium gluconate is associated with low acute toxicity in rats following oral administration. The reported oral LD50 of potassium gluconate was 6060 mg/kg body weight in male and female Wistar rats in a study performed to test guidelines (Spanjers and Til, 1978). Transient clinical signs included sluggishness, humpback behaviour, and severe diarrhea and 7 out of 10 animals died at the high dose level of 6.21 g/kg bw between 5 and 21 hours after administration of the test article. There were no macroscopic findings at necropsy. Only 2 out of 10 animals died following application of 5.19 g/kg bw.   Information on the acute dermal toxicity effects of D-glucono-1,5-lactone was obtained from data on the read across substance, gluconic acid. Gluconic acid is associated with low acute toxicity following dermal administration in rats. The dermal LD50 value for gluconic acid was determined to be greater than 2000 mg/kg body weight in rats in a study performed according to test guidelines and good laboratory practice (Mortier, 2009). There were no mortalities, adverse clinical effects, body weight effects, dermal reactions, or adverse findings in organ or tissue at necropsy.   In accordance with column 2 of REACH Annex VIII, the acute toxicity by inhalation study (required in section 8.5.2) does not need to be conducted as acute toxicity studies are available for the oral and dermal routes of exposure and as inhalative exposure is unlikely. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25fbb925-35c9-46d1-a8c8-e8efe728ad1b/documents/febb8aab-c9ea-4e25-88f2-d1833c01211d_11bb642d-4842-4f8c-a7b0-c8baf97ae4da.html,,,,,, "D-glucono-1,5-lactone",90-80-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25fbb925-35c9-46d1-a8c8-e8efe728ad1b/documents/febb8aab-c9ea-4e25-88f2-d1833c01211d_11bb642d-4842-4f8c-a7b0-c8baf97ae4da.html,,oral,LD50,"6,060 mg/kg bw",no adverse effect observed, "D-glucono-1,5-lactone",90-80-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25fbb925-35c9-46d1-a8c8-e8efe728ad1b/documents/febb8aab-c9ea-4e25-88f2-d1833c01211d_11bb642d-4842-4f8c-a7b0-c8baf97ae4da.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Glutamic acid,56-86-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37e3c18b-c91d-45d8-aeab-a411855269ee/documents/IUC5-ae2ec061-caac-487b-beec-b18a4f71570a_ab47c131-cabd-4866-9270-9c8cad206ba3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,500 mg/kg bw/day",,dog Glutamic acid,56-86-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37e3c18b-c91d-45d8-aeab-a411855269ee/documents/IUC5-ee202867-c1a3-40c2-a746-ffeb39e3ab76_ab47c131-cabd-4866-9270-9c8cad206ba3.html,,oral,LD50,"5,110 mg/kg bw",, Glutamic acid,56-86-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37e3c18b-c91d-45d8-aeab-a411855269ee/documents/IUC5-ee202867-c1a3-40c2-a746-ffeb39e3ab76_ab47c131-cabd-4866-9270-9c8cad206ba3.html,,dermal,LD50,"2,000 mg/kg bw",, Levoglutamide,56-85-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP guideline study with Klimisch Code 1. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0155c997-1cd5-469d-bc34-a196acda0173/documents/IUC5-0fce1c6b-5d9f-40bd-a6fa-991edd51a8cb_c5e22e79-c0a0-4328-a287-363950af1d61.html,,,,,, Levoglutamide,56-85-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0155c997-1cd5-469d-bc34-a196acda0173/documents/IUC5-0fce1c6b-5d9f-40bd-a6fa-991edd51a8cb_c5e22e79-c0a0-4328-a287-363950af1d61.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,786.3 mg/kg bw/day,,rat Glutaral,111-30-8," For the oral route, three studies performed in compliance with OECD guidelines and following GLP are available. NOAELs determined in these three studies were similar and ranged from 14.6 to 23.0 mg/kg bw pure glutaraldehyde. The NOAEL after oral exposure was determined to be 15 mg/kg bw. For the inhalation route, several studies indicate that glutaraldehyde affects primarily the respiratory tract. Systemic effects were also observed, but were rather mild and mostly at concentrations above the NOAEC for local effects. Based on all available data, the NOAECs for local and systemic effects were determined to be 0.25 and 0.5 mg/m3, respectively. For the dermal route, a 13 week dermal rat study was conducted according to OECD TG 411. The NOAEL level for systemic toxicity was established at 150 mg/kg/day, the highest dose tested. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ad9b82f-5e59-4bcf-b75a-8e11a144c034/documents/IUC5-6ed8c605-7991-4cd5-bd3b-4a22036ccf88_a6b350f6-74d0-4e6a-8ce9-2a4cd262b625.html,,,,,, Glutaral,111-30-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ad9b82f-5e59-4bcf-b75a-8e11a144c034/documents/IUC5-6ed8c605-7991-4cd5-bd3b-4a22036ccf88_a6b350f6-74d0-4e6a-8ce9-2a4cd262b625.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat Glutaral,111-30-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ad9b82f-5e59-4bcf-b75a-8e11a144c034/documents/IUC5-6ed8c605-7991-4cd5-bd3b-4a22036ccf88_a6b350f6-74d0-4e6a-8ce9-2a4cd262b625.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,150 mg/kg bw/day,,rat Glutaral,111-30-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ad9b82f-5e59-4bcf-b75a-8e11a144c034/documents/IUC5-6ed8c605-7991-4cd5-bd3b-4a22036ccf88_a6b350f6-74d0-4e6a-8ce9-2a4cd262b625.html,Chronic toxicity – systemic effects,inhalation,NOAEC,0.5 mg/m3,,mouse Glutaral,111-30-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ad9b82f-5e59-4bcf-b75a-8e11a144c034/documents/IUC5-6ed8c605-7991-4cd5-bd3b-4a22036ccf88_a6b350f6-74d0-4e6a-8ce9-2a4cd262b625.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.25 mg/m3,adverse effect observed,mouse Glutaral,111-30-8," Valid acute toxicity data for the oral, dermal and inhalation route of exposure are available for glutaraldehyde 50% aqueous solution. The LD50/LC50 obtained from these studies were as follows: - Acute oral toxicity (rat): LD50 = 77 mg/kg bw (pure glutaraldehyde) - Acute dermal toxicity (rat): LD50 > 2000 mg/kg bw (50% glutaraldehyde) - Acute inhalation toxicity (rat, 4 h exposure): 0.28 < LC50 < 0.39 mg/L air (50% glutaraldehyde) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ad9b82f-5e59-4bcf-b75a-8e11a144c034/documents/IUC5-951e3d9a-3c71-4c1a-ad6c-ca1984ee2455_a6b350f6-74d0-4e6a-8ce9-2a4cd262b625.html,,,,,, Glutaral,111-30-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ad9b82f-5e59-4bcf-b75a-8e11a144c034/documents/IUC5-951e3d9a-3c71-4c1a-ad6c-ca1984ee2455_a6b350f6-74d0-4e6a-8ce9-2a4cd262b625.html,,oral,LD50,77 mg/kg bw,adverse effect observed, Glutaral,111-30-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ad9b82f-5e59-4bcf-b75a-8e11a144c034/documents/IUC5-951e3d9a-3c71-4c1a-ad6c-ca1984ee2455_a6b350f6-74d0-4e6a-8ce9-2a4cd262b625.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Glutaral,111-30-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ad9b82f-5e59-4bcf-b75a-8e11a144c034/documents/IUC5-951e3d9a-3c71-4c1a-ad6c-ca1984ee2455_a6b350f6-74d0-4e6a-8ce9-2a4cd262b625.html,,inhalation,LC50,280 mg/m3,adverse effect observed, Glutaric acid,110-94-1," The toxicity of glutaric acid following short-term repeated oral exposure was assessed using a read-across from the analogous substance adipic acid supported by available experimental data on glutaric acid. Horn et al. (1957) derived a NOAEL of 3% for adipic acid in the diet for male rats following a chronic exposure, and above 0.1% of adipic acid in the diet for female rats as it was the highest concentration evaluated. These values are equivalent respectively to 2,070 mg/kg bw/day and 80 mg/kg bw/day. No specific target organ toxicity was identified, as the only adverse effects observed were a reduced body weight and a lower body weight gain in the groups receiving the highest concentrations of adipic acid in the diet when compared to the control groups, related to a reduced food consumption. These results were supported by Moody et al. (1978) who did not observe any significant effects when focusing on the liver of male rats exposed to 2% of adipic acid in the diet for three weeks – considered as equivalent to 2,000 mg/kg bw/day – and by the historical uses of adipic acid in foodstuff, feed and industrial processes. The experimental data on adipic acid are supported by the consistent results obtained from two subchronic studies on glutaric acid performed by Solutia Inc. (1977a, 1977b) and used as a weight of evidence for the purpose of this assessment. Results from these studies were used to derive a NOAEL above 2% in the diet for the male rats and 1% for the females following subchronic exposure to glutaric acid, equivalent to 1,720 mg/kg bw/day for the males and 980 mg/kg bw for the female rats. No specific target organ toxicity has been identified as the only significant effect observed was a reduction of the body weight of the female rats. These results are supported by the fact that glutaric acid is naturally produced in the human body during the metabolisation of several amino acids. The overall conclusion for this Registration Assessment Report, is a proposed NOAEL of 1,720 mg/kg bw/day of glutaric acid in the diet for male rats and 980 mg/kg bw/day of glutaric acid in the diet for female rats. These values are deemed to be conservative because they are derived from the results of longer-term exposure to glutaric acid while the purpose of this assessment is to assess the toxicity of glutaric acid following a short-term exposure. These values are also lower than those derived from the testing performed on the analogous substance adipic acid. No specific target organ toxicity was identified. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4537c7a6-b846-48b1-8bd5-5bcc30936d13/documents/586cfa9b-423e-4769-af58-3922d83ba5d5_9e812f35-7ac0-4520-98cd-5f41e3021f4b.html,,,,,, Glutaric acid,110-94-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4537c7a6-b846-48b1-8bd5-5bcc30936d13/documents/586cfa9b-423e-4769-af58-3922d83ba5d5_9e812f35-7ac0-4520-98cd-5f41e3021f4b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,980 mg/kg bw/day,,rat Glutaric acid,110-94-1," In accordance with Annex VII and Annex VIII of REACH, the acute toxicity does not need to be investigated as the substance is classified as corrosive to the skin. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4537c7a6-b846-48b1-8bd5-5bcc30936d13/documents/18cc4a7d-fecf-4775-b5df-88610627c1e2_9e812f35-7ac0-4520-98cd-5f41e3021f4b.html,,,,,, "Glycerol, ethoxylated",31694-55-0,"NOAEL (28 days repeated dose, Wistar): ≥ 1000 mg/kg bw. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4b7c2d3-ba42-4e2b-a32f-c4871e522113/documents/IUC5-a8b0c76d-5637-42ad-ae8f-ffaac053e507_c45ab6ef-8728-4a89-b8b4-21173f8eb547.html,,,,,, "Glycerol, ethoxylated",31694-55-0,"Acute toxicity, oral, Wistar rats (according to OECD TG 423, GLP): LD50 (predicted) > 5000 mg/kg bw. No mortality, clinical signs or necropsy findings were observed after treatment of 6 female animals with 2000 mg/kg bw test substance (BASF SE, 2011).Acute toxicity, dermal, Wistar rats (according to OECD TG 402, GLP): LD50> 5000 mg/kg bw (mortality 0/10); no clinical signs or necropsy findings were observed (BASF SE, 2011). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4b7c2d3-ba42-4e2b-a32f-c4871e522113/documents/IUC5-37895c71-1ec8-4a24-b18b-6e4f8510bd5b_c45ab6ef-8728-4a89-b8b4-21173f8eb547.html,,,,,, Glycerol,56-81-5,"In the best available dietary study, groups of 22 rats (Long-Evans)/sex/treatment received 5, 10 and 20% glycerol (natural or synthetic) in their diet (males 2000, 4000 and 8000 mg/kg bw; females 2500, 5000 and 10000 mg/kg bw) for 2 years. Although the results were not described in detail, based on this limited dietary study it can be concluded that no adverse effects were observed at up to 10,000 mg/kg bw.   The effect of glycerine following administration for 90 days in a subchronic toxicity study was examined.  Rats fed 5 or 20% glycerine in the diet for 90 days gained weight at a faster rate than control animals. There were no adverse treatment related effects noted in male or female rats fed 5% glycerine in the diet.  In the male rats which received 20 percent glycerine, there was an increase in the final liver/body weight ratio and upon microscopic examination generalized cloudy swelling and hypertrophy of the parenchymal cells was observed. The only effect in the female rats on this level was some generalized cloudy selling upon microscopic examination of the liver.  A 5% glycerol in the diet corresponded to 4580 and 6450 mg/kg/day for male and female rats, respectively, after 4 weeks and a 20% glycerol in the diet corresponded to 18,750 and 25,800 mg/kg/day for male and female rats, respectively, after 4 weeks.   A number of other studies have been incorporated in the dossier. These studies are considered less reliable indicators of the systemic effects of glycerol following repeated administration, mainly because of limited toxicity assessments and/or deficient experimental design. The effects they do report are consistent with those observed in the key studies and as such they may contribute to the overall assessment of toxicity of glycerol.     The effects following repeated dermal application of glycerin was examined. There were no effects noted in rabbits dosed 8 hours/day, 5 days/week for 45 weeks with dose levels as high as 4.0 ml/kg.  Using a density of 1.2611 g/cm3 at 20 °C, a dose of 4.0 ml/kg corresponds to 5040 mg/kg/day.   The subchronic toxicity of glycerol was examined following aerosol exposure. The NOAEC for local and systemic toxicity was 622 mg/m3. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): The available information meets the information requirements under REACH Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The available information meets the information requirements under REACH ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b5de1db-9033-4e96-9022-c68ca931d367/documents/IUC5-6a907739-cd5e-4fcf-9949-e31a6ed6fde5_a62f75a6-add2-469b-bac2-eace87d27794.html,,,,,, Glycerol,56-81-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b5de1db-9033-4e96-9022-c68ca931d367/documents/IUC5-6a907739-cd5e-4fcf-9949-e31a6ed6fde5_a62f75a6-add2-469b-bac2-eace87d27794.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"5,040 mg/kg bw/day",,rabbit Glycerol,56-81-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b5de1db-9033-4e96-9022-c68ca931d367/documents/IUC5-6a907739-cd5e-4fcf-9949-e31a6ed6fde5_a62f75a6-add2-469b-bac2-eace87d27794.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,622 mg/m3,,rat Glycerol,56-81-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b5de1db-9033-4e96-9022-c68ca931d367/documents/IUC5-6a907739-cd5e-4fcf-9949-e31a6ed6fde5_a62f75a6-add2-469b-bac2-eace87d27794.html,Chronic toxicity – systemic effects,oral,NOAEL,"10,000 mg/kg bw/day",,rat Glycerol,56-81-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b5de1db-9033-4e96-9022-c68ca931d367/documents/IUC5-6a907739-cd5e-4fcf-9949-e31a6ed6fde5_a62f75a6-add2-469b-bac2-eace87d27794.html,Repeated dose toxicity – local effects,inhalation,NOAEC,662 mg/m3,no adverse effect observed,rat Glycerol,56-81-5,"The acute oral LD50 was determined in three species, rat, mice and guinea pigs. In all three species the oral LD50 was >/= 11,500 mg/kg.The acute dermal toxicity of glycerin was examined in guinea pigs.The dermal LD50 was determined to be 45 ml/kg (56,750 mg/kg) in guinea pigs.In an inhalation study, rats were exposed to aerosol from test material at targeted concentrations of 1.0, 2.0, or 4.0 mg glycerol/L for 6 hours. The 4 h inhalation LC50 was determined to be above 5.85 mg/L in rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b5de1db-9033-4e96-9022-c68ca931d367/documents/IUC5-600a9e6c-7f74-4855-97e8-92c31ebbeec2_a62f75a6-add2-469b-bac2-eace87d27794.html,,,,,, Glycerol,56-81-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b5de1db-9033-4e96-9022-c68ca931d367/documents/IUC5-600a9e6c-7f74-4855-97e8-92c31ebbeec2_a62f75a6-add2-469b-bac2-eace87d27794.html,,oral,LD50,"11,500 mg/kg bw",no adverse effect observed, Glycerol,56-81-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b5de1db-9033-4e96-9022-c68ca931d367/documents/IUC5-600a9e6c-7f74-4855-97e8-92c31ebbeec2_a62f75a6-add2-469b-bac2-eace87d27794.html,,dermal,LD50,"56,750 mg/kg bw",no adverse effect observed, Glycerol,56-81-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b5de1db-9033-4e96-9022-c68ca931d367/documents/IUC5-600a9e6c-7f74-4855-97e8-92c31ebbeec2_a62f75a6-add2-469b-bac2-eace87d27794.html,,inhalation,LC50,> 5.85 mg/L,no adverse effect observed, "Docosanoic acid, monoester with glycerol",30233-64-8,"Data on repeated dose toxicity of glycerol monobehenate was not available. However, data from other glyceryl monoesters with structural and functional similarities are available and were included in this weight of evidence assessment. Data on Docosanoic acid (behenic acid) was also used as well as data on glycerol. The available data has been extracted from expert opinions (CIR 2016; CIR 2019; EFSA 2017; OECD 2001). No signs of toxicity were observed in two 28-day studies for glyceryl rosinate and glycerides, C8-18 and C18-unsatd. mono- and di-, acetates. The NOAEL for these two studies is therefore the highest dose tested which was 1000 mg/kg bw/day.This was also concluded for Docosanoic acid (behenic acid) in an OECD 422 study, the NOAEL was set to be > 1000 mg/kg bw/day as no treatment-related adverse effects were observed. In their evaluation of glycerol, EFSA (2017), also concluded no concern for repeated dose toxicity. Overall, they concluded that there was no safety concern regarding the use of glycerol (E 422) as a food additive.Based on the available data used in a weight of evidence approach, it can be concluded that monobehenate is of very low concern for repeated dose toxicity; and it can with a high degree of confidence be concluded that an assumed NOAEL is above 1000 mg/kg bw/day, which is normally considered as the highest relevant dose level when testing for repeated dose toxicity. Thus, no STOT RE classification according to (EC) No 1272/2008 is not warranted. The available information comprises adequate, reliable studies from reference substances with similar structure and intrinsic properties. The weight-of evidence approach is justified based on common functional group and common precursors/breakdown products. The information from these independent sources is consistent and provides sufficient weight of evidence leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2692315b-a133-433f-a986-81601a471c03/documents/a8e467ca-f4c9-4e0e-b7f7-b03a19764e1f_8c0fd461-d74b-4da3-94d8-ad332a01d490.html,,,,,, "Docosanoic acid, monoester with glycerol",30233-64-8,"Docosanoic acid, monoester with glycerol (glycerol monobehenate) is a mono constituent substance with a purity of 80-90%.Test data on acute toxicity of docosanoic acid, monoester with glycerol (Glycerol monobehenate) as well as for other glycerol monoesters of fatty acidsare available. The acute toxicity is therefore based on a weight of evidence analysis. Based on the studies available for docosanoic acid, monoester with glycerol (Glycerol monobehenate) and the relevant hydrolysis products, it can be concluded that the substance has low acute oral and dermal toxicity with LD50-values above the highest dose used for classification as acute toxicity (i.e., 2000-5000 mg/kg).Thus, glycerol monobehenate is not to be classified for acute oral and dermal toxicity. Further, inhalation is not considered a relevant exposure route for humans. The available information comprises adequate, reliable studies from reference substances with similar structure and intrinsic properties. The weight-of-evidence approach is justified based on common functional group and common precursors/breakdown products. The information from these independent sources is consistent and provides sufficient weight of evidence leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006.  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Data are available for docosanoic acid, monoester with glycerol (glycerol monobehenate) from expert opinions. Because of the structural and functional similarities, data from other expert opinions on glyceryl monoesters are also included in this weight of evidence assessment as supporting data. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Inhalation is not considered a relevant exposure route for humans. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): No acute dermal toxicity data available for docosanoic acid, monoester with glycerol (glycerol monobehenate) from expert opinions. Because of the structural and functional similarities, data from expert opinions on other glyceryl monoesters has been used in this weight of evidence assessment. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2692315b-a133-433f-a986-81601a471c03/documents/7e193861-6a84-4281-b3d0-7a1abfe3e2ac_8c0fd461-d74b-4da3-94d8-ad332a01d490.html,,,,,, "Docosanoic acid, monoester with glycerol",30233-64-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2692315b-a133-433f-a986-81601a471c03/documents/7e193861-6a84-4281-b3d0-7a1abfe3e2ac_8c0fd461-d74b-4da3-94d8-ad332a01d490.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Docosanoic acid, monoester with glycerol",30233-64-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2692315b-a133-433f-a986-81601a471c03/documents/7e193861-6a84-4281-b3d0-7a1abfe3e2ac_8c0fd461-d74b-4da3-94d8-ad332a01d490.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Decanoic acid, monoester with glycerol",26402-22-2, Oral (read-across OECD 423): LD50 > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/033b9484-e917-4c14-9ef3-c1e778294d7f/documents/0570ca87-1611-4e64-8e73-71b0d935e85c_86137aa3-f674-4bd7-bce7-9e09c2fa0416.html,,,,,, "Decanoic acid, monoester with glycerol",26402-22-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/033b9484-e917-4c14-9ef3-c1e778294d7f/documents/0570ca87-1611-4e64-8e73-71b0d935e85c_86137aa3-f674-4bd7-bce7-9e09c2fa0416.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Octanoic acid, monoester with glycerol",26402-26-6,"A testing proposal to perform a Repeated dose 90-day oral toxicity study in rodents (OECD 408) by oral route in the rat with octanoic acid, monoester with glycerol (CAS 26402-26-6, EC 247-668-1) was submitted. The new data will be included, and the hazard and risk assessment will be updated when the study report is available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8fab1ea-5586-453b-b5f3-3f0b461c1aa4/documents/IUC5-c0263101-e231-462e-8377-2ce57a3a38b0_f76cfd93-d7f7-4440-b279-25d808b45aaa.html,,,,,, "Octanoic acid, monoester with glycerol",26402-26-6,"Acute oral toxicity, rat (OECD 401, GLP): LD50 > 5000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8fab1ea-5586-453b-b5f3-3f0b461c1aa4/documents/IUC5-9b2f7c89-6661-4372-993a-029bf8cb9953_f76cfd93-d7f7-4440-b279-25d808b45aaa.html,,,,,, "D-Glucose, ether with glycerol",100402-60-6,Under the test conditions the test item showed a no-observed-adverse-effect level (NOAEL) of greater than 1000 mg/kg bw/day for systemic changes. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29d13927-65e8-4207-adcc-ef397bd9b7a7/documents/IUC5-c07c5e65-37b4-42d5-a3a2-e58478c8e3de_5d3a1f7f-67e6-4071-95d1-7d38281dfe3d.html,,,,,, "D-Glucose, ether with glycerol",100402-60-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29d13927-65e8-4207-adcc-ef397bd9b7a7/documents/IUC5-c07c5e65-37b4-42d5-a3a2-e58478c8e3de_5d3a1f7f-67e6-4071-95d1-7d38281dfe3d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "D-Glucose, ether with glycerol",100402-60-6,"Oral:Under the experimental conditions described in the study, the oral LD 50 of the test item was found to be greater than 2000 mg/kg bw in the rat.Dermal:Under the experimental conditions described in the study report, the dermal LD50 of the test item was found to be greater than 2000 mg/kg bw in rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29d13927-65e8-4207-adcc-ef397bd9b7a7/documents/IUC5-3d0b127c-2e7c-4773-8bed-b81639f1461b_5d3a1f7f-67e6-4071-95d1-7d38281dfe3d.html,,,,,, "D-Glucose, ether with glycerol",100402-60-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29d13927-65e8-4207-adcc-ef397bd9b7a7/documents/IUC5-3d0b127c-2e7c-4773-8bed-b81639f1461b_5d3a1f7f-67e6-4071-95d1-7d38281dfe3d.html,,oral,LD50,"2,000 mg/kg bw",, "D-Glucose, ether with glycerol",100402-60-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29d13927-65e8-4207-adcc-ef397bd9b7a7/documents/IUC5-3d0b127c-2e7c-4773-8bed-b81639f1461b_5d3a1f7f-67e6-4071-95d1-7d38281dfe3d.html,,dermal,LD50,"2,000 mg/kg bw",, "Resin acids and Rosin acids, hydrogenated, esters with glycerol",65997-13-9," Information is available on the oral repeated dose toxicity of Rosin esters (simple, linear, and bulky). No treatment-related or biologically relevant findings were apparent in rats following oral sub-chronic dietary exposure to Resin acids and rosin acids, esters with glycerol, Resin acids and rosin acids, esters with ethylene glycol, Resin acids and rosin acids, esters with triethylene glycol, Resin acids and rosin acids, hydrogenated, esters with glycerol and Resin acids and rosin acids, hydrogenated, esters with pentaerythritol. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cdc48ae9-96b0-4368-9b00-507009c4483d/documents/2adc7197-7f1f-4e8f-a338-e70e91b3936a_7d3e3b79-2a14-4356-9b42-54e46cba56ef.html,,,,,, "Resin acids and Rosin acids, hydrogenated, esters with glycerol",65997-13-9,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cdc48ae9-96b0-4368-9b00-507009c4483d/documents/4f855724-8d9a-4aab-b824-a894e85f0fa4_7d3e3b79-2a14-4356-9b42-54e46cba56ef.html,,,,,, "Resin acids and Rosin acids, hydrogenated, esters with glycerol",65997-13-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cdc48ae9-96b0-4368-9b00-507009c4483d/documents/4f855724-8d9a-4aab-b824-a894e85f0fa4_7d3e3b79-2a14-4356-9b42-54e46cba56ef.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, hydrogenated, esters with glycerol",65997-13-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cdc48ae9-96b0-4368-9b00-507009c4483d/documents/4f855724-8d9a-4aab-b824-a894e85f0fa4_7d3e3b79-2a14-4356-9b42-54e46cba56ef.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydroxyoctadecanoic acid, monoester with glycerol",1323-42-8," No adverse effects observed in 13-week dietary study of castor oil, a structural analogue of the registered substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01e8c174-fcb6-4844-8eba-b216b27a4484/documents/0541d14f-9aab-4b7e-a3bd-c83a3cca18de_1155012d-14e6-41c2-bc1a-a06afbe0fc12.html,,,,,, "Hydroxyoctadecanoic acid, monoester with glycerol",1323-42-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01e8c174-fcb6-4844-8eba-b216b27a4484/documents/0541d14f-9aab-4b7e-a3bd-c83a3cca18de_1155012d-14e6-41c2-bc1a-a06afbe0fc12.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"5,725 mg/kg bw/day",,rat "Hydroxyoctadecanoic acid, monoester with glycerol",1323-42-8, No adverse effects for acute toxicity endpoints. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01e8c174-fcb6-4844-8eba-b216b27a4484/documents/e2fd920a-07cd-4764-a522-940c282bda57_1155012d-14e6-41c2-bc1a-a06afbe0fc12.html,,,,,, "Hydroxyoctadecanoic acid, monoester with glycerol",1323-42-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01e8c174-fcb6-4844-8eba-b216b27a4484/documents/e2fd920a-07cd-4764-a522-940c282bda57_1155012d-14e6-41c2-bc1a-a06afbe0fc12.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Isooctadecanoic acid, monoester with glycerol",66085-00-5,All the available subacute repeated dose toxicity studies resulted in a NOAEL ≥ 1000 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/003a86e6-58d3-4022-889b-3d678a4572af/documents/IUC5-7598346c-a0fb-421f-bcd3-110471fe5f07_fb4bed05-2374-4ed0-a3f1-7cabd35a698b.html,,,,,, "Isooctadecanoic acid, monoester with glycerol",66085-00-5,The available acute oral toxicity study performed with the target substance Glycerol monoisostearate resulted in an acute oral LD50 > 2000 mg/kg bw. The available acute dermal toxicity study performed with 2 source substances resulted in an acute dermal LD50 > 2000 mg/kg bw. The available acute inhalation toxicity study performed with a source substance resulted in an acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/003a86e6-58d3-4022-889b-3d678a4572af/documents/IUC5-c26449bd-99a3-4c21-bf43-169d9140ce29_fb4bed05-2374-4ed0-a3f1-7cabd35a698b.html,,,,,, "2,3-dihydroxypropyl laurate",142-18-7,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83a7e88c-6174-4504-8ced-c9cf9f6703ec/documents/IUC5-100d09c9-bec5-46ea-87dd-82f55c82d3ca_a0c4793c-7fc1-4fa0-b54b-fa7d48fb0542.html,,,,,, "2,3-dihydroxypropyl laurate",142-18-7,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83a7e88c-6174-4504-8ced-c9cf9f6703ec/documents/IUC5-694f4908-af3e-4729-afa2-3635b21d3d49_a0c4793c-7fc1-4fa0-b54b-fa7d48fb0542.html,,,,,, "Lauric acid, ester with hydroxypropanediyl diacetate",30899-62-8,"Oral: OECD 422, rat, NOAEL ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/804853fc-9cc7-4544-9e6c-667d31a8925d/documents/IUC5-55f0d8f0-c920-42ed-9286-c00b89ab9601_202022bc-2d1d-4931-acb2-8f243b314a12.html,,,,,, "Lauric acid, ester with hydroxypropanediyl diacetate",30899-62-8,"Oral: LD50 = > 2000 mg/kg bw Inhalation: LC50 > 9.65 mg/L (time-extrapolated value, corresponding to 1.86 mg/L after 6 h exposure)Dermal: LD50 > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/804853fc-9cc7-4544-9e6c-667d31a8925d/documents/IUC5-72129ac4-ae80-4ba5-98b6-070178b21401_202022bc-2d1d-4931-acb2-8f243b314a12.html,,,,,, "2,3-dihydroxypropyl methacrylate",5919-74-4," NOAEL (OECD 422, oral, rat): 150 mg/kg bw/day RA-A CAS 27813-02-1: NOAEL (OECD 422, oral, rat) = 300 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eaf91768-edf9-46d6-ae4c-1ac4ecb47cc8/documents/874da44f-8766-43aa-aead-f27337dc50c4_5c137773-4e2a-4ba2-a12b-3846275f2667.html,,,,,, "2,3-dihydroxypropyl methacrylate",5919-74-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eaf91768-edf9-46d6-ae4c-1ac4ecb47cc8/documents/874da44f-8766-43aa-aead-f27337dc50c4_5c137773-4e2a-4ba2-a12b-3846275f2667.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "2,3-dihydroxypropyl methacrylate",5919-74-4, The oral LD50 was > 2000 mg/kg bw. The acute dermal LD50 was found to be > 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eaf91768-edf9-46d6-ae4c-1ac4ecb47cc8/documents/acb0de22-fd38-4b50-828b-cc810337058a_5c137773-4e2a-4ba2-a12b-3846275f2667.html,,,,,, "2,3-dihydroxypropyl methacrylate",5919-74-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eaf91768-edf9-46d6-ae4c-1ac4ecb47cc8/documents/acb0de22-fd38-4b50-828b-cc810337058a_5c137773-4e2a-4ba2-a12b-3846275f2667.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,3-dihydroxypropyl methacrylate",5919-74-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eaf91768-edf9-46d6-ae4c-1ac4ecb47cc8/documents/acb0de22-fd38-4b50-828b-cc810337058a_5c137773-4e2a-4ba2-a12b-3846275f2667.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Glycerol monomyristate,27214-38-6," Oral: OECD 422, rat, NOAEL ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1aeabd3d-ab5f-473d-8bb0-a4d00dec37bc/documents/6cf30269-faf0-4cf2-b420-0a538897f983_20a37911-b547-449f-a5e4-9e3fe1596977.html,,,,,, Glycerol monomyristate,27214-38-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1aeabd3d-ab5f-473d-8bb0-a4d00dec37bc/documents/6cf30269-faf0-4cf2-b420-0a538897f983_20a37911-b547-449f-a5e4-9e3fe1596977.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Glycerol monomyristate,27214-38-6, Oral: LD50 > 2000 mg/kg bw Dermal: LD50 > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aeabd3d-ab5f-473d-8bb0-a4d00dec37bc/documents/ff727b58-0289-4898-8988-09617f8a1ab1_20a37911-b547-449f-a5e4-9e3fe1596977.html,,,,,, "Glycerides, C16-18",68002-71-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ebc2bd90-c1c0-44ed-a642-fb8fc32f9c04/documents/IUC5-9f1efe99-98f3-413a-9d52-8c6463e0e515_84f2c6d2-6924-431e-899c-ca37757cb186.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,750 mg/kg bw/day",,rat "Glycerides, C16-18",68002-71-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebc2bd90-c1c0-44ed-a642-fb8fc32f9c04/documents/IUC5-97df975b-bbab-4929-b559-1b09c78a2fcd_84f2c6d2-6924-431e-899c-ca37757cb186.html,,oral,LD50,"> 4,000 mg/kg bw",no adverse effect observed, "Glycerides, C16-18",68002-71-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebc2bd90-c1c0-44ed-a642-fb8fc32f9c04/documents/IUC5-97df975b-bbab-4929-b559-1b09c78a2fcd_84f2c6d2-6924-431e-899c-ca37757cb186.html,,dermal,LD50,"> 3,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, esters with glycerol",8050-31-5," Information is available on the oral repeated dose toxicity of Rosin esters (simple, linear, and bulky). No treatment-related or biologically relevant findings were apparent in rats following oral sub-chronic dietary exposure to Resin acids and rosin acids, esters with glycerol, Resin acids and rosin acids, esters with ethylene glycol, Resin acids and rosin acids, esters with triethylene glycol, Resin acids and rosin acids, hydrogenated, esters with glycerol and Resin acids and rosin acids, hydrogenated, esters with pentaerythritol. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/560359b3-73fc-4fa1-a2a6-efa0c0978c62/documents/26144e9b-a2d6-4aa8-83cf-86519fb996f7_8f38d538-1a98-4aaf-a7cb-49ad6beb2b24.html,,,,,, "Resin acids and Rosin acids, esters with glycerol",8050-31-5,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/560359b3-73fc-4fa1-a2a6-efa0c0978c62/documents/d38658d0-1155-4ab8-875c-9704125df66c_8f38d538-1a98-4aaf-a7cb-49ad6beb2b24.html,,,,,, "Resin acids and Rosin acids, esters with glycerol",8050-31-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/560359b3-73fc-4fa1-a2a6-efa0c0978c62/documents/d38658d0-1155-4ab8-875c-9704125df66c_8f38d538-1a98-4aaf-a7cb-49ad6beb2b24.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, esters with glycerol",8050-31-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/560359b3-73fc-4fa1-a2a6-efa0c0978c62/documents/d38658d0-1155-4ab8-875c-9704125df66c_8f38d538-1a98-4aaf-a7cb-49ad6beb2b24.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Stearic acid, monoester with glycerol",31566-31-1,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc380bda-2f00-4f7b-b52e-609b1d076ba0/documents/d6713815-947d-4c08-81ac-82160afb6370_0c2d50c2-ed0a-4259-8122-9c6d7a9c6bb7.html,,,,,, "Stearic acid, monoester with glycerol",31566-31-1,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc380bda-2f00-4f7b-b52e-609b1d076ba0/documents/419196ae-2cab-4817-9e50-5e9ba62028fd_0c2d50c2-ed0a-4259-8122-9c6d7a9c6bb7.html,,,,,, "Mercaptoacetic acid, monoester with propane-1,2,3-triol",30618-84-9,The subacute oral NOAEL for GMT is 50 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77eb8da7-63ba-40a0-9494-449a844c5507/documents/IUC5-d1d8c981-d977-462a-9ee3-d2435f28763d_34689131-d7d0-4841-a9e7-c6996041988b.html,,,,,, "Mercaptoacetic acid, monoester with propane-1,2,3-triol",30618-84-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77eb8da7-63ba-40a0-9494-449a844c5507/documents/IUC5-d1d8c981-d977-462a-9ee3-d2435f28763d_34689131-d7d0-4841-a9e7-c6996041988b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Mercaptoacetic acid, monoester with propane-1,2,3-triol",30618-84-9,GMT is toxic if swallowed but non-toxic via dermal exposure. Inhalative toxicity was not determined because inhalation is not a relevant exposure route. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77eb8da7-63ba-40a0-9494-449a844c5507/documents/IUC5-70aecfe4-91df-45d6-b3d5-211f319d382f_34689131-d7d0-4841-a9e7-c6996041988b.html,,,,,, "Mercaptoacetic acid, monoester with propane-1,2,3-triol",30618-84-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77eb8da7-63ba-40a0-9494-449a844c5507/documents/IUC5-70aecfe4-91df-45d6-b3d5-211f319d382f_34689131-d7d0-4841-a9e7-c6996041988b.html,,oral,LD50,172 mg/kg bw,no adverse effect observed, "Mercaptoacetic acid, monoester with propane-1,2,3-triol",30618-84-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77eb8da7-63ba-40a0-9494-449a844c5507/documents/IUC5-70aecfe4-91df-45d6-b3d5-211f319d382f_34689131-d7d0-4841-a9e7-c6996041988b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,2,3-propanetriyl tris[(R)-12-(acetoxy)oleate]",101-34-8," Key information has been conducted according to recognised testing guidelines, prior to the adoption of the OECD principles of GLP in 1992. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b625b3c9-244f-44b2-976d-baf87a050bac/documents/9bad0e5b-d8c0-4d3c-b034-e779f703c5e6_5faa9394-b006-4a1f-9239-88a5a0a0a9e2.html,,,,,, "[3-(2,3-epoxypropoxy)propyl]trimethoxysilane",2530-83-8,"There are no sub-chronic repeated dose toxicity data for the registered substance, [3-(2,3-epoxypropoxy)propyl]trimethoxysilane (CAS 2530-83-8, EC 219-784-2). Therefore, key data are read-across from the structural analogue, [2-(3,4-epoxycyclohexyl)ethyl]triethoxysilane (CAS 10217-34-2, EC 425-050-4). In the key sub-chronic toxicity study in rats for the analogue [2-(3,4-epoxycyclohexyl)ethyl]triethoxysilane (CAS 10217-34-2, EC 425-050-4), conducted according to OECD Test Guideline 408 and in compliance with GLP, the NOAEL was concluded to be ≥1000 mg/kg bw/day (NOTOX, 1998, reliability 1).         ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc822980-32ba-4ba0-bb15-3784133e92d4/documents/325a38bb-20f6-4a75-86ac-85a57f467293_3d30bf25-c810-4819-b3d9-d0cc05e36747.html,,,,,, "[3-(2,3-epoxypropoxy)propyl]trimethoxysilane",2530-83-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc822980-32ba-4ba0-bb15-3784133e92d4/documents/325a38bb-20f6-4a75-86ac-85a57f467293_3d30bf25-c810-4819-b3d9-d0cc05e36747.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,119 mg/m3,,rat "[3-(2,3-epoxypropoxy)propyl]trimethoxysilane",2530-83-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc822980-32ba-4ba0-bb15-3784133e92d4/documents/325a38bb-20f6-4a75-86ac-85a57f467293_3d30bf25-c810-4819-b3d9-d0cc05e36747.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "[3-(2,3-epoxypropoxy)propyl]trimethoxysilane",2530-83-8,"The registered substance, [3-(2,3-epoxypropoxy)propyl]trimethoxysilane (CAS 2530-83-8, EC 219-784-2), has been tested in several acute toxicity studies via the oral, inhalation and dermal routes. The key acute, oral (gavage), toxicity study was conducted in rats according to a protocol similar to the now deleted OECD Test Guideline 401 but not in compliance with GLP; an LD50 of 8025 mg/kg bw was reported (Dow Corning Corporation, 1976, reliability 2). The key acute inhalation study was conducted in rats according to OECD Test Guideline 403 and in compliance with GLP. An LC50 of >5300 mg/m3 (>5.3 mg/l) was reported (Allied Corporation, 1982, reliability 1). The key acute dermal study was conducted pre-guideline and pre-GLP although the protocol was similar to OECD Test Guideline 402. An LD50 of 4250 mg/kg bw was reported (Mellon Institute, 1962, reliability 2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc822980-32ba-4ba0-bb15-3784133e92d4/documents/071f1572-e76e-4275-86b1-083ac8c4955e_3d30bf25-c810-4819-b3d9-d0cc05e36747.html,,,,,, "[3-(2,3-epoxypropoxy)propyl]trimethoxysilane",2530-83-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc822980-32ba-4ba0-bb15-3784133e92d4/documents/071f1572-e76e-4275-86b1-083ac8c4955e_3d30bf25-c810-4819-b3d9-d0cc05e36747.html,,oral,LD50,"8,025 mg/kg bw",no adverse effect observed, "[3-(2,3-epoxypropoxy)propyl]trimethoxysilane",2530-83-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc822980-32ba-4ba0-bb15-3784133e92d4/documents/071f1572-e76e-4275-86b1-083ac8c4955e_3d30bf25-c810-4819-b3d9-d0cc05e36747.html,,dermal,LD50,"4,248 mg/kg bw",no adverse effect observed, "[3-(2,3-epoxypropoxy)propyl]trimethoxysilane",2530-83-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc822980-32ba-4ba0-bb15-3784133e92d4/documents/071f1572-e76e-4275-86b1-083ac8c4955e_3d30bf25-c810-4819-b3d9-d0cc05e36747.html,,inhalation,LC50,"5,300 mg/m3",no adverse effect observed, Glycine,56-40-6," NOAEL (male, oral, glycine) ≥ 2000 mg/kg bw/d (28 days) LOAEL (male/female, oral, glycine) = 1561 mg/kg bw/d (108 weeks) NOAEL (male/female), oral, N-acetylglycine)  ≥ 1000 mg/kg bw/d (28 days) LOAEL (male/female, subcutaneous, glycine) = 1500 mg/kg bw/d (108 weeks) NOAEL (male, intraperitoneal, glycine) ≥ 600 mg/kg bw/d (26 weeks) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0eca25ce-f17c-45aa-8390-7e48fbf72add/documents/IUC5-e2e9df19-a72a-4b7f-b2f4-e6d119e889dd_7dc0c526-78d6-4126-9c71-766d4cd33027.html,,,,,, Glycine,56-40-6," Oral: Hazard assessment is based on the weight of evidence from all available studies. LD50 (oral) rat, male/female: 9550/7930 mg/kg bw LD50 (oral) mice, male/female: 5640/4920 mg/kg bw Inhalation: No study required since exposure of humans via inhalation is unlikely based on the low vapour pressure, MMAD and exposure considerations. No hazard is expected based on the available data on the acute oral toxicity. Dermal: No study required since exposure of humans via skin is unlikely based on QSAR predictions with the available data on the physico-chemical properties of the substance. However, systemic toxic effects after acute dermal exposure are unlikely to occur based on the available data on the acute oral toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0eca25ce-f17c-45aa-8390-7e48fbf72add/documents/IUC5-abce1869-db69-4044-abca-37e99d5e919b_7dc0c526-78d6-4126-9c71-766d4cd33027.html,,,,,, Glycine hydrochloride,6000-43-7," Based on the pH of 1.2 (see reference 4.20-1), the test item is classified as corrosive to the skin (H314). According to REACH Annex VII, 8.5 Column 2, no test for acute oral toxcicity is necessary. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf003268-3327-4cb7-b941-3bccb703bfed/documents/b650b7fc-6423-4778-b33d-71440023a7ea_e7371489-6d9b-4a33-bc25-54f3eceb08f3.html,,,,,, "Ethane-1,2-diol",107-21-1, Oral: A NOEL of 150 mg/kg bw/day was determined in rats with regard to oral exposure. The kidneys were found to be the target organ at higher doses. Dermal: A NOAEL was found to be 2200 mg/kg bw/day in dogs. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8a17560-be4e-45c5-aa92-548ce44d469e/documents/cc8afadc-01e8-4441-a6fa-5730291fcdc7_bed17eca-301f-4a77-acfb-1c31143606e3.html,,,,,, "Ethane-1,2-diol",107-21-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8a17560-be4e-45c5-aa92-548ce44d469e/documents/cc8afadc-01e8-4441-a6fa-5730291fcdc7_bed17eca-301f-4a77-acfb-1c31143606e3.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,200 mg/kg bw/day",,dog "Ethane-1,2-diol",107-21-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8a17560-be4e-45c5-aa92-548ce44d469e/documents/cc8afadc-01e8-4441-a6fa-5730291fcdc7_bed17eca-301f-4a77-acfb-1c31143606e3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Ethane-1,2-diol",107-21-1, BASF (1968) reported an acute oral LD50 value of 7712 mg/kg for male and female rats. Tyl (1985) reported an acute inhalative LC50 value of > 2.5 mg/L air for a six-hour exposure for male and female rats. An acute dermal LD50 value of > 3500 mg/kg for male and female mice was derived by Tyl (1988). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8a17560-be4e-45c5-aa92-548ce44d469e/documents/IUC5-fcb809bb-e426-4b9d-95ec-3e297a13d33b_bed17eca-301f-4a77-acfb-1c31143606e3.html,,,,,, "Ethane-1,2-diol",107-21-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8a17560-be4e-45c5-aa92-548ce44d469e/documents/IUC5-fcb809bb-e426-4b9d-95ec-3e297a13d33b_bed17eca-301f-4a77-acfb-1c31143606e3.html,,oral,LD50,"7,712 mg/kg bw",adverse effect observed, "Ethane-1,2-diol",107-21-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8a17560-be4e-45c5-aa92-548ce44d469e/documents/IUC5-fcb809bb-e426-4b9d-95ec-3e297a13d33b_bed17eca-301f-4a77-acfb-1c31143606e3.html,,dermal,discriminating dose,"3,500 mg/kg bw",adverse effect observed, "Ethane-1,2-diol",107-21-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8a17560-be4e-45c5-aa92-548ce44d469e/documents/IUC5-fcb809bb-e426-4b9d-95ec-3e297a13d33b_bed17eca-301f-4a77-acfb-1c31143606e3.html,,inhalation,discriminating conc.,"2,500 mg/m3",adverse effect observed, Ethylene dimethacrylate,97-90-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Although read-across has been used the database is regarded as being of high quality because relevant additional information from longer-term studies with metabolites and related chemicals is available which supports the assessment for EGDMA (read across done with a high level of confidence (see chapter toxicokinetics and category document, respectively)). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dcc60354-1599-4828-add7-65bfb2b5d7d4/documents/IUC5-5d7b3679-4a80-4b18-b9ec-823f6e3f474a_10b83006-52ee-447d-b3ed-cf90848baebc.html,,,,,, Ethylene dimethacrylate,97-90-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dcc60354-1599-4828-add7-65bfb2b5d7d4/documents/IUC5-5d7b3679-4a80-4b18-b9ec-823f6e3f474a_10b83006-52ee-447d-b3ed-cf90848baebc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Ethylene dimethacrylate,97-90-5,Ethyleneglycol dimethacrylate is of low acute oral and dermal toxicity. LD50 is higher than 2000 mg/kg bw in rats. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcc60354-1599-4828-add7-65bfb2b5d7d4/documents/IUC5-0879b31b-816e-477c-929f-1e60d2c90e61_10b83006-52ee-447d-b3ed-cf90848baebc.html,,,,,, Ethylene dimethacrylate,97-90-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcc60354-1599-4828-add7-65bfb2b5d7d4/documents/IUC5-0879b31b-816e-477c-929f-1e60d2c90e61_10b83006-52ee-447d-b3ed-cf90848baebc.html,,oral,LD50,"8,700 mg/kg bw",, Ethylene dimethacrylate,97-90-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcc60354-1599-4828-add7-65bfb2b5d7d4/documents/IUC5-0879b31b-816e-477c-929f-1e60d2c90e61_10b83006-52ee-447d-b3ed-cf90848baebc.html,,dermal,LD50,"2,000 mg/kg bw",, Ethylene distearate,627-83-8,"Oral (subacute): NOAEL (systemic toxicity) ≥ 1000 mg/kg bw/day Conclusion based on data obtained with ethylene distearate (EC 211-014-3, CAS 627-83-8) and considering all available data on subacuteoral toxicity in the ethylene glycol esters category in a weight of evidence approach.   Oral (subchronic): NOAEL (systemic toxicity) ≥ 1000 mg/kg bw/day Read-across based on grouping of substances (analogue approach) considering all available data on subchronic repeated dose toxicity with the source substances decanoic acid, mixed diesters with octanoic acid and propylene glycol (EC 271-516-3, CAS 68583-51-7), fatty acids, C18 and C18 unsatd. epoxidized, ester with ethylene glycol (CAS 151661-88-0), and stearic acid, monoester with propane-1,2-diol (EC 215-354-3, CAS 1323-39-3; all not part of the ethylene glycol esters category) in a weight of evidence approach. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ee3d71a-f0db-47c9-a888-0107f9d1b912/documents/IUC5-c5c5dd9c-045f-4d20-a1d4-cd2301d3569a_5f2f0062-0783-425a-a1cb-18b6b744ba6a.html,,,,,, Ethylene distearate,627-83-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ee3d71a-f0db-47c9-a888-0107f9d1b912/documents/IUC5-c5c5dd9c-045f-4d20-a1d4-cd2301d3569a_5f2f0062-0783-425a-a1cb-18b6b744ba6a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat Ethylene distearate,627-83-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ee3d71a-f0db-47c9-a888-0107f9d1b912/documents/IUC5-c5c5dd9c-045f-4d20-a1d4-cd2301d3569a_5f2f0062-0783-425a-a1cb-18b6b744ba6a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat Ethylene distearate,627-83-8,"Oral LD50 > 2000 mg/kg bw Conclusion based on data with ethylene distearate (EC 211-014-3, CAS 627-83-8) and considering all available data on acute oral toxicity in the ethylene glycol esters category in a weight of evidence approach.   Inhalation No information is required according to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, as data on acute oral toxicity are provided and the oral and dermal route are considered more relevant.   Dermal No information is required according to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5.2, Column 2, as the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure performed with ethylene glycol category substances. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ee3d71a-f0db-47c9-a888-0107f9d1b912/documents/IUC5-4feb2b45-1b7a-4cc4-9e8c-f6d2412db3cf_5f2f0062-0783-425a-a1cb-18b6b744ba6a.html,,,,,, Ethylene distearate,627-83-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ee3d71a-f0db-47c9-a888-0107f9d1b912/documents/IUC5-4feb2b45-1b7a-4cc4-9e8c-f6d2412db3cf_5f2f0062-0783-425a-a1cb-18b6b744ba6a.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-hydroxyethyl palmitate,4219-49-2,"Repeated dose toxicity: Oral NOAEL (rat, m/f): 1000 mg/kg bw/day (OECD 408, category approach) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5dbf8a0-d01e-4260-8ffe-45da49c4c97e/documents/37932a5b-3f0e-4762-9b22-29229aba6aef_c3656ced-6a45-48e6-810f-847fb2737fdc.html,,,,,, 2-hydroxyethyl palmitate,4219-49-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5dbf8a0-d01e-4260-8ffe-45da49c4c97e/documents/37932a5b-3f0e-4762-9b22-29229aba6aef_c3656ced-6a45-48e6-810f-847fb2737fdc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, 2-hydroxyethyl palmitate,4219-49-2,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401, GLP, category approach)Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, GLP, category approach)Acute toxicity: Inhalation LC50 (rat, m/f): > 2.916 mg/L air (OECD 403, category approach) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5dbf8a0-d01e-4260-8ffe-45da49c4c97e/documents/c5c08b73-e366-48d9-adfb-3f2a186c2664_c3656ced-6a45-48e6-810f-847fb2737fdc.html,,,,,, 2-hydroxyethyl palmitate,4219-49-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5dbf8a0-d01e-4260-8ffe-45da49c4c97e/documents/c5c08b73-e366-48d9-adfb-3f2a186c2664_c3656ced-6a45-48e6-810f-847fb2737fdc.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-hydroxyethyl palmitate,4219-49-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5dbf8a0-d01e-4260-8ffe-45da49c4c97e/documents/c5c08b73-e366-48d9-adfb-3f2a186c2664_c3656ced-6a45-48e6-810f-847fb2737fdc.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-hydroxyethyl palmitate,4219-49-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5dbf8a0-d01e-4260-8ffe-45da49c4c97e/documents/c5c08b73-e366-48d9-adfb-3f2a186c2664_c3656ced-6a45-48e6-810f-847fb2737fdc.html,,inhalation,LC50,> 2.916 mg/L,no adverse effect observed, "Fatty acids, tall-oil, esters with ethylene glycol",68187-85-9," Oral (read-across, similar to OECD 408) NOAEL m/f rat ≥1000 mg/kg bw/day The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62c1b880-3add-450f-851a-b223e01b5af7/documents/c594d0fc-ff12-4620-9187-ed73989513f9_9c4816e8-d075-4f40-813d-cf0caf066947.html,,,,,, "Fatty acids, tall-oil, esters with ethylene glycol",68187-85-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62c1b880-3add-450f-851a-b223e01b5af7/documents/c594d0fc-ff12-4620-9187-ed73989513f9_9c4816e8-d075-4f40-813d-cf0caf066947.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, tall-oil, esters with ethylene glycol",68187-85-9," Oral (read-across, OECD 401): LD50 m/f rat > 2000 mg/kg bw Dermal (read-across, equivalent to OECD 402): LD50 m/f rat > 2000 mg/kg bw The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62c1b880-3add-450f-851a-b223e01b5af7/documents/6392ab0a-0ebd-4798-9c7f-7326506c9ae9_9c4816e8-d075-4f40-813d-cf0caf066947.html,,,,,, Glycollic acid,79-14-1,"A key repeated dose study is available for glycolic acid. In this 90-day oral toxicity gavage study in rats in which effects were observed at the dose levels of 300 or 600 mg/kg bw/day. These included lower mean body weight, overall body weight gain, food consumption and food efficiency. No adverse clinical signs indicative of systemic toxicity and no test substance-related ophthalmological findings were observed. Toxicologically significant increased neutrophil levels in male rats dosed with 300 mg/kg per day or 600 mg/kg per day and increased urea nitrogen, phosphorus, and creatine and decreased urine concentration in male rats dosed with 300 mg/kg per day or 600 mg/kg per day were observed. Mean kidney weight of male rats in the 300 mg/kg per day and 600 mg/kg per day were significantly higher than that of the control group. Gross findings of renal pelvis dilation were observed and correlated with microscopic findings of oxalate crystal nephrosis and unilateral hydronephrosis in males dosed with 300 or 600 mg/kgper day. The effects were not evident at the 150 mg/kg bw/day level. The NOEL for this study is based on 100% glycolic acid dosed (adjusted for 70% purity of the test substance). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/608d89de-ebc8-4e02-bf32-9915d448bad9/documents/0bc1dcf6-6273-4921-abc7-8741f7866f7f_3a42948f-8cb7-4360-bf11-fb689cd4fe63.html,,,,,, Glycollic acid,79-14-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/608d89de-ebc8-4e02-bf32-9915d448bad9/documents/0bc1dcf6-6273-4921-abc7-8741f7866f7f_3a42948f-8cb7-4360-bf11-fb689cd4fe63.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Glycollic acid,79-14-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/608d89de-ebc8-4e02-bf32-9915d448bad9/documents/0bc1dcf6-6273-4921-abc7-8741f7866f7f_3a42948f-8cb7-4360-bf11-fb689cd4fe63.html,Repeated dose toxicity – local effects,inhalation,NOAEC,230 mg/m3,adverse effect observed,rat Glycollic acid,79-14-1,"Acute oral LD50 in rats of a 70% glycolic acid solution was >2000 mg/kg bw. The LD50 was based on 100% glycolic acid dosed (adjusted for 70% purity of the test substance).The acute inhalation median lethal concentration for a 4-hour nose-only exposure was 3.6 mg/L for male rats and 5.2 mg/L for female rats.In view of the extensive human exposure without adverse effect as a consequence of cosmetic uses, no dermal toxicity study was conducted. No dermal toxicity is anticipated. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/608d89de-ebc8-4e02-bf32-9915d448bad9/documents/d6edf1a8-9ec7-40fb-a2ab-018b851a4d65_3a42948f-8cb7-4360-bf11-fb689cd4fe63.html,,,,,, Glycollic acid,79-14-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/608d89de-ebc8-4e02-bf32-9915d448bad9/documents/d6edf1a8-9ec7-40fb-a2ab-018b851a4d65_3a42948f-8cb7-4360-bf11-fb689cd4fe63.html,,oral,LD50,"2,040 mg/kg bw",, Glycollic acid,79-14-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/608d89de-ebc8-4e02-bf32-9915d448bad9/documents/d6edf1a8-9ec7-40fb-a2ab-018b851a4d65_3a42948f-8cb7-4360-bf11-fb689cd4fe63.html,,inhalation,LC50,"3,600 mg/m3",, glyoxal … %; ethandial … %,107-22-2," Oral: The oral toxicity of Glyoxal (40 % aq. sol.) was assessed in rats following repeated administration via drinking water over 28 days (CIT 2619 TSR, OECD TG 407). The LOAEL was 300 mg/kg bw/day and the NOAEL was 100 mg/kg bw/day, referring to the active ingredient. Two 90 days oral studies (drinking water) were conducted according to the OECD TG 408. The NOAEL of the first study with rats (BASF 50S0496/01233) was 1000 ppm, corresponding to 72 mg/kg bw/day in males and 92.6 mg/kg bw/day in females. The second one was conducted with mice (BASF 51S0496/01234), yielding a NOAEL of 1000 ppm, corresponding to 160 and 212 mg/kg bw/day for males and females. The NOAEL value of 72 mg/kg bw/day obtained from the rat study was retained as general NOAEL for the oral repeated dose toxicity.  Dermal: Referring to the dermal route of exposure, data from a preliminary test conducted for the purpose of dosage estimation for a main dermal carcinogenicity study are available and were considered as weight of evidence (BRRC 45-508). The study resulted in a NOAEL for systemic toxicity of ca. 125 mg/kg bw/day (highest dose tested) and a NOAEL for local effects (skin lesions) of ca. 63 mg/kg bw/day. Inhalation: The subacute inhalation toxicity was conducted in rats of both sexes exposed to Glyoxal aerosol (6 hrs/day, 5 days/week) over 29 days (Hoechst 94.1056, OECD TG 412). This study resulted in a NOAEC of 0.4 mg/m3 air. Local effects were observed in the larynx. Thus, the upper respiratory tract appears to be the main target for Glyoxal under repeated inhalation conditions. As support, the publication of Gamer and coworkers (Gamer et al., 2008) investigating laryngeal epithelial alteration related to inhalation also was considered. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/895e89c1-1ba7-4f9d-b55c-a5971f21b8e4/documents/IUC5-76850b43-07db-4c1c-aaef-a58c76632272_518f8623-fa23-46d8-9072-917599915481.html,,,,,, glyoxal … %; ethandial … %,107-22-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/895e89c1-1ba7-4f9d-b55c-a5971f21b8e4/documents/IUC5-76850b43-07db-4c1c-aaef-a58c76632272_518f8623-fa23-46d8-9072-917599915481.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,125 mg/kg bw/day,,mouse glyoxal … %; ethandial … %,107-22-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/895e89c1-1ba7-4f9d-b55c-a5971f21b8e4/documents/IUC5-76850b43-07db-4c1c-aaef-a58c76632272_518f8623-fa23-46d8-9072-917599915481.html,Chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat glyoxal … %; ethandial … %,107-22-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/895e89c1-1ba7-4f9d-b55c-a5971f21b8e4/documents/IUC5-76850b43-07db-4c1c-aaef-a58c76632272_518f8623-fa23-46d8-9072-917599915481.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.4 mg/m3,adverse effect observed,rat glyoxal … %; ethandial … %,107-22-2," oral Acute oral toxicity (BASF AG 85/16): LD50 (males + females) > 2000 mg/kg bw and < 5000 mg/kg bw Acute oral toxicity (Hoechst AG 84.0195): LD50 (males + females) = 3300 mg/kg bw inhalation Acute inhalation toxicity, aerosol (Hoechst 84.0378): LC50 (males + females) = 2.44 mg/L air Acute inhalation toxicity, dust (Hoechst 84.0693): LC50 (males + females) > 1.3 mg/L air dermal Acute dermal toxicity (BASF AG 85/248): LD50 (males + females) > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/895e89c1-1ba7-4f9d-b55c-a5971f21b8e4/documents/IUC5-b92d645f-3b0c-4b74-be9b-bfd0428b26d8_518f8623-fa23-46d8-9072-917599915481.html,,,,,, glyoxal … %; ethandial … %,107-22-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/895e89c1-1ba7-4f9d-b55c-a5971f21b8e4/documents/IUC5-b92d645f-3b0c-4b74-be9b-bfd0428b26d8_518f8623-fa23-46d8-9072-917599915481.html,,oral,LD50,"3,300 mg/kg bw",adverse effect observed, glyoxal … %; ethandial … %,107-22-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/895e89c1-1ba7-4f9d-b55c-a5971f21b8e4/documents/IUC5-b92d645f-3b0c-4b74-be9b-bfd0428b26d8_518f8623-fa23-46d8-9072-917599915481.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, glyoxal … %; ethandial … %,107-22-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/895e89c1-1ba7-4f9d-b55c-a5971f21b8e4/documents/IUC5-b92d645f-3b0c-4b74-be9b-bfd0428b26d8_518f8623-fa23-46d8-9072-917599915481.html,,inhalation,LC50,"2,440 mg/m3",adverse effect observed, Glyoxylic acid,298-12-4,In a repeated dose toxicity study according to OECD guideline 422 the NOAEL was 200 mg/kg bw/d. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86514447-336f-4f8c-bbab-20c2c1bfbea8/documents/IUC5-8299d4c9-5050-4f4f-bc83-50a605b35961_0feaa3f8-ad70-43b9-9424-132dff7f64bc.html,,,,,, Glyoxylic acid,298-12-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86514447-336f-4f8c-bbab-20c2c1bfbea8/documents/IUC5-8299d4c9-5050-4f4f-bc83-50a605b35961_0feaa3f8-ad70-43b9-9424-132dff7f64bc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Glyoxylic acid,298-12-4,The oral LD50 value in the rat is 2528 mg/kg bw. The dermal LD50 in the rat was > 2000 mg/kg bw. The acute dermal toxicity study showed no mortality. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86514447-336f-4f8c-bbab-20c2c1bfbea8/documents/IUC5-95799896-b844-4454-bf79-15f198180e7f_0feaa3f8-ad70-43b9-9424-132dff7f64bc.html,,,,,, Glyoxylic acid,298-12-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86514447-336f-4f8c-bbab-20c2c1bfbea8/documents/IUC5-95799896-b844-4454-bf79-15f198180e7f_0feaa3f8-ad70-43b9-9424-132dff7f64bc.html,,oral,LD50,"2,528 mg/kg bw",, Tetrachloroauric acid,16903-35-8," An MTD study (Rhodes 2015) was conducted to determine the maximum tolerated dose over short repeat-dose periods. The study was performed using dose levels unadjusted for the density of the test material, the adjustment being applied to the dose levels after completion of the study. The follow-up main study (Rhodes 2015), according to OECD422 guidelines was also conducted with dose levels unadjusted for the compound density. Fromulation analysis of solutions prepared for the main OECD422 study gave results that were outside the acceptable range of variation of such analyses. Consequently, the main OECD422 study was repeated (LPT 2017) in which dose levels were prepared on a w/v basis thus taking into consideration the density of the test material in the production of the dose concentrations. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cea6e77d-0a27-4c46-8043-26aa4ac49c9d/documents/9ac10d9a-90d2-4130-a5bb-17f7d8f59bfd_4602c16a-96b8-485e-bd2c-2f57dba5c32a.html,,,,,, Tetrachloroauric acid,16903-35-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cea6e77d-0a27-4c46-8043-26aa4ac49c9d/documents/9ac10d9a-90d2-4130-a5bb-17f7d8f59bfd_4602c16a-96b8-485e-bd2c-2f57dba5c32a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Tetrachloroauric acid,16903-35-8,"In accordance with column 2 of REACH Annex VII and Annex VIII, acute toxicity studies do not need to be conducted since the substance is classified as corrosive to the skin. An existing non-GLP acute oral toxicity study (OECD Guideline 401) in rats suggested that the LD50 for tetrachloroauric(III) acid to be > 464 mg/kg bw. However, this was based on a study using testsolutions of very low pH and not neutralised as in other subsequent studies ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cea6e77d-0a27-4c46-8043-26aa4ac49c9d/documents/IUC5-6d0a7be9-66a8-45f8-a3ad-2bcd1358b93c_4602c16a-96b8-485e-bd2c-2f57dba5c32a.html,,,,,, Tetrachloroauric acid,16903-35-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cea6e77d-0a27-4c46-8043-26aa4ac49c9d/documents/IUC5-6d0a7be9-66a8-45f8-a3ad-2bcd1358b93c_4602c16a-96b8-485e-bd2c-2f57dba5c32a.html,,oral,LD50,464 mg/kg bw,adverse effect observed, Guaiacol,90-05-1,"Based on the only study available with reliability 2, a LOAEL of 1500 mg/kg/day was identified in rats after oral route exposure to guaiacol, the NOAEL is lower than 1500 mg/kg (published data).No data are available by dermal route and by inhalation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc9d31f1-496f-44a5-a15e-846ad1bfd654/documents/IUC5-61838b35-f182-40a6-b034-b3700ff8cc40_a48dd215-be0f-43ca-b80f-4cd94aeaa0bc.html,,,,,, Guaiacol,90-05-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc9d31f1-496f-44a5-a15e-846ad1bfd654/documents/IUC5-61838b35-f182-40a6-b034-b3700ff8cc40_a48dd215-be0f-43ca-b80f-4cd94aeaa0bc.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,"1,500 mg/kg bw/day",,rat Guaiacol,90-05-1,LD50 oral on rat: 621-725 mg/kg (published data)(reliability 2)LC50 inhalation on mice (2h): 7.57 mg/L (published data)(reliability 4) LD50 dermal on rabbit: 4600 mg/kg (published data)(reliability 2) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc9d31f1-496f-44a5-a15e-846ad1bfd654/documents/IUC5-f97ec8c9-1541-43fc-9387-7e8625844ad6_a48dd215-be0f-43ca-b80f-4cd94aeaa0bc.html,,,,,, Guaiacol,90-05-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc9d31f1-496f-44a5-a15e-846ad1bfd654/documents/IUC5-f97ec8c9-1541-43fc-9387-7e8625844ad6_a48dd215-be0f-43ca-b80f-4cd94aeaa0bc.html,,oral,LD50,621 mg/kg bw,adverse effect observed, Guaiacol,90-05-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc9d31f1-496f-44a5-a15e-846ad1bfd654/documents/IUC5-f97ec8c9-1541-43fc-9387-7e8625844ad6_a48dd215-be0f-43ca-b80f-4cd94aeaa0bc.html,,dermal,LD50,"4,600 mg/kg bw",no adverse effect observed, Diguanidinium carbonate,593-85-1,"- 28 d repeated dose oral toxicity: NOAEL ≥ 300 mg/kg bw/day, OECD TG 407 28 d, gavage ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8dc99c9b-ae6a-404e-a8b9-69ffb4840dbd/documents/IUC5-dbcb851b-714f-435f-b98f-c36505c6f697_b1b98c0e-9d64-4e0a-9f05-bace582409b8.html,,,,,, Diguanidinium carbonate,593-85-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8dc99c9b-ae6a-404e-a8b9-69ffb4840dbd/documents/IUC5-dbcb851b-714f-435f-b98f-c36505c6f697_b1b98c0e-9d64-4e0a-9f05-bace582409b8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Diguanidinium carbonate,593-85-1,"- Oral: LD50 rat: 1089 mg/kg (m) and 1045 mg/kg (f), generally compliant to OECD TG 401- Dermal: LD50: > 2000 mg/kg in female rats, OECD TG 402 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dc99c9b-ae6a-404e-a8b9-69ffb4840dbd/documents/IUC5-34157d9f-4d18-4f2c-95cd-b3f43a502335_b1b98c0e-9d64-4e0a-9f05-bace582409b8.html,,,,,, Diguanidinium carbonate,593-85-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dc99c9b-ae6a-404e-a8b9-69ffb4840dbd/documents/IUC5-34157d9f-4d18-4f2c-95cd-b3f43a502335_b1b98c0e-9d64-4e0a-9f05-bace582409b8.html,,oral,LD50,"1,045 mg/kg bw",adverse effect observed, Diguanidinium carbonate,593-85-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dc99c9b-ae6a-404e-a8b9-69ffb4840dbd/documents/IUC5-34157d9f-4d18-4f2c-95cd-b3f43a502335_b1b98c0e-9d64-4e0a-9f05-bace582409b8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Guanidinium chloride,50-01-1, A No Observed Adverse Effect Level (NOAEL) of 100 mg/kg body weight/day for repeated dose toxicity was established from an oral subchronic toxicity study according to OECD guideline 408 with Guanidine hydrochloride. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a6a06a1-47ad-4aa9-9179-46637fed644a/documents/IUC5-3b258c86-5fa6-435c-946f-e4c71367a123_142a9ee2-8b90-4a3c-9893-f006a6928a33.html,,,,,, Guanidinium chloride,50-01-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a6a06a1-47ad-4aa9-9179-46637fed644a/documents/IUC5-3b258c86-5fa6-435c-946f-e4c71367a123_142a9ee2-8b90-4a3c-9893-f006a6928a33.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Guanidinium chloride,50-01-1," Acute toxicity data on Guanidine hydrochloride are available for the oral, inhalation and dermal route. The data available from three studies for the oral route all indicate LD50 values for Guanidine hydrochloride in the range between 773.6 and 1120 mg/kg bw.The LC50 from an inhalation study for females is 3.181 mg/L air (LC50 for males = 7.655 mg/L air).The dermal LD50 is > 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a6a06a1-47ad-4aa9-9179-46637fed644a/documents/IUC5-8235e318-544b-439c-b5ac-4281785fe3b3_142a9ee2-8b90-4a3c-9893-f006a6928a33.html,,,,,, Guanidinium chloride,50-01-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a6a06a1-47ad-4aa9-9179-46637fed644a/documents/IUC5-8235e318-544b-439c-b5ac-4281785fe3b3_142a9ee2-8b90-4a3c-9893-f006a6928a33.html,,oral,LD50,773.6 mg/kg bw,adverse effect observed, Guanidinium chloride,50-01-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a6a06a1-47ad-4aa9-9179-46637fed644a/documents/IUC5-8235e318-544b-439c-b5ac-4281785fe3b3_142a9ee2-8b90-4a3c-9893-f006a6928a33.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Guanidinium chloride,50-01-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a6a06a1-47ad-4aa9-9179-46637fed644a/documents/IUC5-8235e318-544b-439c-b5ac-4281785fe3b3_142a9ee2-8b90-4a3c-9893-f006a6928a33.html,,inhalation,LC50,"3,181 mg/m3",adverse effect observed, Guanidinium phosphate (1:1),5423-22-3," A sub-acute study (oral; 28 days exposure) performed according to OECD/EC guidelines and GLP principles, is available for guanidine phosphate (1:1). Based on this study, a No Observed Adverse Effect Level (NOAEL) of 200 mg/kg was established. Based on a 90-day repeated dose study performed according to OECD guideline and GLP principles, the no observed adverse effect level (NOAEL) of analogue guanidinium hydrochloride is considered to be 100 mg/kg body weight/day. This value for sub-chronic exposure is read across to guanidine phosphate (1:1). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34ab54ce-2e32-4f81-9974-b7f1a77a1175/documents/IUC5-5490ba84-fa1e-4b1a-a9dc-d5ca376a8319_966cf7c3-9691-4b11-bd7e-699ee3521669.html,,,,,, Guanidinium phosphate (1:1),5423-22-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34ab54ce-2e32-4f81-9974-b7f1a77a1175/documents/IUC5-5490ba84-fa1e-4b1a-a9dc-d5ca376a8319_966cf7c3-9691-4b11-bd7e-699ee3521669.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Guanidinium phosphate (1:1),5423-22-3,"In an acute oral toxicity study with rats, performed according to OECD/EC test guidelines and GLP principles, an LD50 between 300 and 2000 mg/kg bw for Guanidinium phosphate (1:1)was determined.In an acute dermal toxicity study with rats, performed according to OECD/EC test guidelines, an LD50 >2000 mg/kg bw for guanidinium phosphate (1:1) was determined. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34ab54ce-2e32-4f81-9974-b7f1a77a1175/documents/IUC5-5fa8bd35-34fe-452a-8d3a-2c49ccbac111_966cf7c3-9691-4b11-bd7e-699ee3521669.html,,,,,, Guanidinium phosphate (1:1),5423-22-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34ab54ce-2e32-4f81-9974-b7f1a77a1175/documents/IUC5-5fa8bd35-34fe-452a-8d3a-2c49ccbac111_966cf7c3-9691-4b11-bd7e-699ee3521669.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Guanidinium phosphate (1:1),5423-22-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34ab54ce-2e32-4f81-9974-b7f1a77a1175/documents/IUC5-5fa8bd35-34fe-452a-8d3a-2c49ccbac111_966cf7c3-9691-4b11-bd7e-699ee3521669.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "dimethyl(3-{[4-(methylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}propyl)propylazanium bromide",502453-61-4,In a dose selection experiment preceding an in vivo Comet assay 3 animals receiving 2000 mg/kg of the test substance died whereas a dose of 600 mg/kg was found to be the maximum tolerated dose. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/003f4946-56ac-4bf4-8e1e-6df56c37ba15/documents/IUC5-c846a84f-25ee-4a7d-92d8-21c7d9cdbea3_188d8ce1-e851-4612-9377-b2ab8f33c811.html,,,,,, "2,2'-[[4-[(2-hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol",33229-34-4,"The test item, HC Blue No 2, when administered daily by gavage to Sprague-Dawley rats at the dose level of 100, 300 or 1000 mg/kg bw/day for 13 weeks was well absorbed and caused purple colouration of urine and, as a consequence, of extremities and excessive salivation in all the treated animals. At 1000 mg/kg bw/day, higher absolute and relative liver and kidney weights were observed in both sexes at the end of the dosing period and the recovery period (except for kidneys in males) while no changes were noted on hematology or biochemistry parameters. Only relative liver increases in females given 1000 mg/kg bw/day were considered to be test item related adverse effects. No treatment related findings were noted at histopathological examination. After a 4 week treatment free period, coloured urine and excessive salivation were no longer observed while the slight increase in liver weights were still observed in females given 1000 mg/kg bw/day. Under the experimental conditions of the study the NOAEL of the test item was considered to be 300 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98ff3270-54b8-45d4-872d-54150d3ed929/documents/IUC5-68319698-d532-4f6c-abe9-0ba72a13d5aa_94d4a3dc-5780-4314-8e58-99c35aa77141.html,,,,,, "2,2'-[[4-[(2-hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol",33229-34-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98ff3270-54b8-45d4-872d-54150d3ed929/documents/IUC5-68319698-d532-4f6c-abe9-0ba72a13d5aa_94d4a3dc-5780-4314-8e58-99c35aa77141.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2,2'-[[4-[(2-hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol",33229-34-4,"The acute oral toxicity of the substance was assessed according to OECD guideline 420 (acute oral toxicity - fixed dose method) in compliance to GLP. Under the experimental conditions, the maximal non-lethal dose of the test item was 2000 mg/kg by oral route in rats. In accordance with Directive 67/548 and Regulation (EC) No 1272/2008 the substance is not classified. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98ff3270-54b8-45d4-872d-54150d3ed929/documents/IUC5-17d445f2-60fe-4247-af50-86aaca2caa83_94d4a3dc-5780-4314-8e58-99c35aa77141.html,,,,,, "2,2'-[[4-[(2-hydroxyethyl)amino]-3-nitrophenyl]imino]bisethanol",33229-34-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98ff3270-54b8-45d4-872d-54150d3ed929/documents/IUC5-17d445f2-60fe-4247-af50-86aaca2caa83_94d4a3dc-5780-4314-8e58-99c35aa77141.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-(4-amino-2-nitroanilino)ethanol,2871-01-4," Based on te result of the key study (NTS, 1979, Klimisck 2, equivalent to OECD guideline), the NOAEL of the registered substance HC Red No 3 for repeated oral dose toxicity was defined at 250 mg/kg bw/day. The registered item was not classified for STOT-RE according to CLP criteria. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da4d6182-76f0-46ac-8711-581fdcb031b6/documents/c7aa8818-e782-44dd-bcef-2e9e60033d66_330c7c2a-22f9-4284-a7ae-f5b44d9e19ae.html,,,,,, 2-(4-amino-2-nitroanilino)ethanol,2871-01-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da4d6182-76f0-46ac-8711-581fdcb031b6/documents/c7aa8818-e782-44dd-bcef-2e9e60033d66_330c7c2a-22f9-4284-a7ae-f5b44d9e19ae.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 2-(4-amino-2-nitroanilino)ethanol,2871-01-4," According to the result of the key study (Sterner, 1983, Klimisch 2, method comparable to OECD 401 ; Burnett, 1987, Klimisch 2, method comparable to OECD 401), the results of the test indicated that the lethal oral dose (LD5O) was 3940 mg/kg in males and 2950 mg/kg in females, for males and females the LD50 value was 3400 mg/kg for the first study. In the second study, the LD50 value was determined to be between 2500mg/kg and 5000 mg/kg. Hence, the test item HC Red 3 was not classififed as Acute Oral Hazard according to CLP regulation and was classified as Category 5 according to GHS regulation. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da4d6182-76f0-46ac-8711-581fdcb031b6/documents/2a762585-1e90-468d-8641-cdbbd58709cd_330c7c2a-22f9-4284-a7ae-f5b44d9e19ae.html,,,,,, 2-(4-amino-2-nitroanilino)ethanol,2871-01-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da4d6182-76f0-46ac-8711-581fdcb031b6/documents/2a762585-1e90-468d-8641-cdbbd58709cd_330c7c2a-22f9-4284-a7ae-f5b44d9e19ae.html,,oral,LD50,"3,400 mg/kg bw",adverse effect observed, 2-[(2-nitrophenyl)amino]ethanol,4926-55-0," According the result of the key studies (Rush, 2005, Klimisch 1, OECD 408 for Definitive Study, GLP, Dose Range Finding Study and Definitive Study), The No Adverse Effect Level NOAEL of the test item HC Yellow No. 2 in a 90 Days Repeated Dose Toxicity Test in rats exposed by oral route was defined at 50 mg/kg/day. No adverse and toxicologically relevant effect was observed in the study. Hence, the test item was not classfified. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0f5e66c-f7c1-4447-ba9d-b021954eb230/documents/5299397f-5ec4-40b3-adfb-bd834a01166f_2cb56065-a8db-4ab5-80ad-d6e5c3ae7f1d.html,,,,,, 2-[(2-nitrophenyl)amino]ethanol,4926-55-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0f5e66c-f7c1-4447-ba9d-b021954eb230/documents/5299397f-5ec4-40b3-adfb-bd834a01166f_2cb56065-a8db-4ab5-80ad-d6e5c3ae7f1d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 2-[(2-nitrophenyl)amino]ethanol,4926-55-0," According to the results of the key study (Burnett, 1987, Klimisch 2), the Lethal Dose 50 (LD50) value of the test item HC Yellow No. 2 was defined between 625 mg/kg and 1250 mg/kg bw through oral gavage route. Hence, according to the CLP criteria, the test item was classified as Acute Oral Hazard Category 4. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0f5e66c-f7c1-4447-ba9d-b021954eb230/documents/c5c9310b-6f42-4276-a524-a4973dda0771_2cb56065-a8db-4ab5-80ad-d6e5c3ae7f1d.html,,,,,, 2-[(2-nitrophenyl)amino]ethanol,4926-55-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0f5e66c-f7c1-4447-ba9d-b021954eb230/documents/c5c9310b-6f42-4276-a524-a4973dda0771_2cb56065-a8db-4ab5-80ad-d6e5c3ae7f1d.html,,oral,LD50,"1,250 mg/kg bw",adverse effect observed, "(2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate",3779-63-3,"Repeated dose toxicity: inhalation For (2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate (EC 223-242-0) no animal studies are available for the endpoint repeated dose toxicity. An analogous read-across approach with reliable study data from the source substance HDI oligomers, isocyanurate (EC 931-274-8) is performed to fill data gaps for the endpoint repeated inhalation toxicity. Reliable subacute and subchronic inhalation study according to OECD TG 412 and OECD 413 with HDI oligomers, isocyanurate are available. Furthermore, (2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate (EC 223-242-0) and HDI oligomers, isocyanurate were tested in studies specifically addressing the pulmonary irritant potency of both substances (Pauluhn, 2012 (for (2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate); Pauluhn, 2001 (for HDI oligomers, isocyanurate)). The study protocols complied with the TRGS 430 (Technical Rule for Hazardous Substances 430, German Federal Ministry of Labour and Social Affairs) and OECD TG 403. A sub-chronic inhalation toxicity study (90 days) according to OECD TG 413 was conducted on 10 test animals per sex and dose group. In this study animals were head/nose exposed to the aerosolised HDI oligomers, isocyanurate (5 days/week, 6h/day) at concentrations of 0 (vehicle control), 0.5, 3.3, and 26.4 mg/m³ (Pauluhn, T7019467, 1987). The aerosol was of adequate respirability for the rats (MMAD approx. 1.5 µm, GSD approx. 1.4). Investigations also included lung function measurements after acetylcholine challenge towards the end of the study. No substance induced mortality was observed in the course of the study. All animals tolerated the treatment virtually without symptoms, except one male of the high dose group (26.4 mg/m³) that exhibited laboured breathing. A slightly reduced body weight gain was observed for the male rats of the 26.4 mg/m³ group towards the end of the study. Body weight gain was not affected for female animals. Lung function tests provided indications of a chronic obstructive lung disorder in rats of the 26.4 mg/m³ group. The absolute and relative lung weights were significantly increased in male and female rats of the 26.4 mg/m³ dose group. Histopathological, inflammatory changes in the respiratory tract (focal fibrosis, proliferation of connective tissue, and increase in macrophages) were seen in the 26.4 mg/m³ dose group and haematological investigations revealed increased leukocyte counts in the same dose group. Other haematological, clinical chemistry and urine analysis parameters remained unchanged. Conclusively, all tests and examinations provided evidence that changes were confined to the respiratory tract of rats repeatedly exposed to 26.4 mg/m³. The location of the damage was essentially limited to the lung periphery. All changes were nonspecific and are thus attributed to the primary irritant potential of the test substance. There were no indications of damage to organs except for the respiratory tract. The NOAEC of this study was 3.3 mg/m³ and the LOAEC was 26.4 mg/m³. A subacute inhalation toxicity study (3 weeks) according to OECD TG 412 was conducted on 10 test animals per sex and dose group. In this study the animals were head/nose exposed to the aerosolised substance (5days/week, 6h/day) at concentrations of 4.3, 14.7, and 89.8 mg/m3. (Pauluhn 1985). The aerosol was of adequate respirability for the rats. No substance induced mortality was observed in the course of the study. Clinical signs occurred for the mid and the high dose groups only. These included bloody noses of slight to moderate intensity; reduced motility on the first two exposure days and for males reduced body weight gain were observed for the high dose group only (89.8 mg/m³). As the symptoms diminished within the course of the study an adaptive effect must have occurred for the rats. At necropsy increased lung weights were seen at dose group 14.7 mg/m³ and above. Histopathological examinations revealed especially for animals exposed to 89.8 mg/m³ inflammatory changes in the lung and hyperaemia with detritus of the nose mucosa. These effects were unspecific and most probably related to the irritant properties of the substance. No other target organs than the respiratory tract were affected. Thus, the NOAEC of this study was 4.3 mg/m³ and the LOAEC was 14.7 mg/m3. The studies described above demonstrated that adverse effects elicited were caused by unspecific irritation-related responses occurring predominantly in the lower respiratory tract. Additionally, (2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate and HDI oligomers, isocyanurate were tested in studies specifically addressing the pulmonary irritant potency of both substances (Pauluhn, 2012 (for (2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate)); Pauluhn, 2001 (for HDI oligomers, isocyanurate)). The study protocols complied with the TRGS 430 (Technical Rule for Hazardous Substances 430, German Federal Ministry of Labour and Social Affairs) and OECD TG 403. The comparison of the two acute inhalation studies according to TRGS 430 shows essentially similar exposure characteristics. Extrapolations revealed non-irritation threshold concentration with NOAECs of 3.2 and 3 mg/m3 for (2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate and HDI oligomers, isocyanurate, respectively) The NOAECs from the sub-chronic and subacute studies correlate well with those from the acute studies (according to TRGS 430) indicating that the observed effect pattern is not progressively increasing with exposure time. Comparison of all findings suggests a NOAEC value in the range of 3-4.3 mg/m3 for both substances, regardless of the exposure duration. The respirable liquid aerosols of HDI oligomers, isocyanurate evaluated resulted in NOAEC values between 3.3 mg/m3 and 4.3 mg/m3 in the sub-chronic and subacute inhalation toxicity studies in rats. Due to the comparable pulmonary irritation behaviour of target and source substance based on comparable physico-chemical properties and structural similarity and comparable NCO contents, the same effects after repeated inhalation exposure can be assumed and an analogue read-across to the target substance is seen as warranted. Accordingly, the NOAEC of the target substance (2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate (EC 223-242-0) is assumed to be 3.3 mg/m³.   Repeated dose toxicity: oral Data requirement is waived. Repeated dose toxicity: dermal Data requirement is waived. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3831974e-7e95-46bd-8385-575a51211a9e/documents/346304d6-74fa-40b0-ab0d-27a9c094ebe4_39b8a4f8-66f2-4f0a-81b7-28e7941a1927.html,,,,,, "(2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate",3779-63-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3831974e-7e95-46bd-8385-575a51211a9e/documents/346304d6-74fa-40b0-ab0d-27a9c094ebe4_39b8a4f8-66f2-4f0a-81b7-28e7941a1927.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,> 26.4 mg/m3,,rat "(2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate",3779-63-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3831974e-7e95-46bd-8385-575a51211a9e/documents/346304d6-74fa-40b0-ab0d-27a9c094ebe4_39b8a4f8-66f2-4f0a-81b7-28e7941a1927.html,Repeated dose toxicity – local effects,inhalation,NOAEC,3.3 mg/m3,adverse effect observed,rat "(2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate",3779-63-3,"Acute oral Toxicity There are no acute oral toxicity study data available for the target substance (2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate (EC 223-242-0). An analogues read-across approach is performed with data of the source substance HDI oligomers, isocyanurate. Valid study data of an acute oral toxicity study (OECD TG 423) are available for the source substance HDI oligomers, isocyanurate. No mortality, no signs of systemic toxicity and no effects on body weight gain were indicated. The LD50 of the test material was estimated according to the flow chart of the OECD TG 423, Annex 2d to be > 2500 mg/kg bw. Based on physico-chemical properties and structural similarity of source and target substance, similarities in acute oral toxicity can be assumed and an analogue read-across approach to the target substance is seen as warranted, thus the target substance is not classified according to Regulation (EC) No 1272/2008 for the endpoint acute oral toxicity.   Acute dermal toxicity The endpoint acute dermal toxicity is waived according to REACH Annex VIII, 8.5.   Acute inhalation toxicity There are no acute inhalation toxicity study data available for LC50 calculation of the target substance (2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate (EC 223-242-0). An analogues read-across approach is performed with valid OECD 403 study data of the source substance HDI oligomers, isocyanurate. The analogues read-across approach is strengthen and supported by valid TRGS 430 study data of target and source substance. A reliable acute inhalation toxicity study according to OECD TG 403 is available for HDI oligomers, isocyanurate  (Pauluhn 1984). Groups of 5 to 10 male and 5 to 10 female Wistar rats were exposed to aerosolised test material. Animals were head-nose exposed to the test substance in concentrations of 150 up to 1033 mg/m³. The aerosol was of adequate respirability for the rats (90 % particles < 5 µm; MMAD 2.5-3 µm / GSD 1.7). Exposure to concentrations up to and including 162 mg/m³ were tolerated without mortality. Aerosol concentrations starting from 283 mg/m³ and higher induced test substance related mortality. Deaths occurred in all groups on the day of exposure and first postexposure days; in some cases up to the fourth postexposure day. Exposure to concentrations of 150 mg/m³ and higher were followed by concentration-dependent signs suggestive of irritation to the respiratory tract (e.g. dyspnoea, bloody snouts, salivation) and non-specific signs such as limp, reduced motility, and loss of body weight. In most instances, signs resolved completely within the first four postexposure days. At necropsy changes in lung parenchyma (toxic lung oedema) were reported and were seen in the context of local irritating properties of the substance. No other necropsy findings than at the respiratory tract were observed. The LC50 (4 h) in rats was calculated to be 543 mg/m³ for males and approx. 390 mg/m³ for females. In summary, signs of respiratory tract irritation were noted after acute exposure (4 hours) with HDI oligomers, isocyanurate, death were driven by toxic lung oedema, the LC 50 value calculated (male/females)  was  462 mg/m3 (543 mg/m³ for males and approx. 390 mg/m³ for females). The analogues read-across approach is supported by pulmonary irritant potency studies done with the target and source substance. (2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate and HDI oligomers, isocyanurate were tested in studies specifically addressing the pulmonary irritant potency of both substances (Pauluhn, 2012, 2001). The study protocols complied with the TRGS 430 (Technical Rule for Hazardous Substances 430, German Federal Ministry of Labour and Social Affairs) and OECD TG 403. Comparison of both TRGS 430 studies revealed that both substances elicited comparable pulmonary irritation effects. The comparison of the two acute inhalation studies according to TRGS 430 shows essentially similar exposure characteristics. Extrapolations revealed non-irritation threshold concentration with NOAELs of 3.2 and 3 mg/m3 for (2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate and HDI oligomers, isocyanurate, respectively) Due to the comparable pulmonary irritation behaviour of target and source substance, which based on comparable physico-chemical properties and structural similarity, similarities in acute inhalation toxicity can be assumed and an the analogue read-across approach to the target substance is seen as warranted. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3831974e-7e95-46bd-8385-575a51211a9e/documents/6f8b3e42-e7d0-4ebb-ae84-727ffed2a9ca_39b8a4f8-66f2-4f0a-81b7-28e7941a1927.html,,,,,, "(2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate",3779-63-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3831974e-7e95-46bd-8385-575a51211a9e/documents/6f8b3e42-e7d0-4ebb-ae84-727ffed2a9ca_39b8a4f8-66f2-4f0a-81b7-28e7941a1927.html,,oral,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, "(2,4,6-trioxotriazine-1,3,5(2H,4H,6H)-triyl)tris(hexamethylene) isocyanate",3779-63-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3831974e-7e95-46bd-8385-575a51211a9e/documents/6f8b3e42-e7d0-4ebb-ae84-727ffed2a9ca_39b8a4f8-66f2-4f0a-81b7-28e7941a1927.html,,inhalation,LC50,390 mg/m3,adverse effect observed, N-(2-hydroxyethyl)ethylenediaminetriacetic acid,150-39-0,There are no repeated dose studies with the substance available. Studies on two structural analogues of the substance (Na3H-EDTA and Na2H2-EDTA) are available (for read-across justification refer to Section 13) which indicate no significant concerns for toxicity/carcinogenicity. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a8be864-85ad-460d-bd11-e15e8e11b387/documents/IUC5-dc14336a-61d7-469e-b284-b491790105cc_73a4efb6-1a36-47eb-a655-b2c15753d33f.html,,,,,, N-(2-hydroxyethyl)ethylenediaminetriacetic acid,150-39-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a8be864-85ad-460d-bd11-e15e8e11b387/documents/IUC5-dc14336a-61d7-469e-b284-b491790105cc_73a4efb6-1a36-47eb-a655-b2c15753d33f.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat N-(2-hydroxyethyl)ethylenediaminetriacetic acid,150-39-0,"Acute oral toxicity - Weight of evidence suggests the median lethal dose to be close to 2000 mg/kg. In the absence of reliable data on the substance itself a key, well documented study, on the analogue tetrasodium EDTA describes the LD50 of that substance as being 1780 mg/kg. This is used to characterise the acute toxicity of this substance and the LD50, re-based according to the molecular weight of the two substances, is therefore taken as being 1303 mg/kg.Acute inhalation toxicity - The LC50(4h) for the structurally related substance Na3-HEDTA is in excess of 3.95 mg/L, the highest exposure concentration achievable.Acute dermal toxicity - No reliable data available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a8be864-85ad-460d-bd11-e15e8e11b387/documents/IUC5-6cff5ac3-44fa-4044-8d86-d460433e8bb2_73a4efb6-1a36-47eb-a655-b2c15753d33f.html,,,,,, N-(2-hydroxyethyl)ethylenediaminetriacetic acid,150-39-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a8be864-85ad-460d-bd11-e15e8e11b387/documents/IUC5-6cff5ac3-44fa-4044-8d86-d460433e8bb2_73a4efb6-1a36-47eb-a655-b2c15753d33f.html,,oral,LD50,"1,303 mg/kg bw",adverse effect observed, N-(2-hydroxyethyl)ethylenediaminetriacetic acid,150-39-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a8be864-85ad-460d-bd11-e15e8e11b387/documents/IUC5-6cff5ac3-44fa-4044-8d86-d460433e8bb2_73a4efb6-1a36-47eb-a655-b2c15753d33f.html,,inhalation,discriminating conc.,"3,950 mg/m3",no adverse effect observed, Piperonal,120-57-0, In a combined 90-day repeated dose toxicity study with the reproduction/developmental toxicity screening test performed according to OECD TGs 422 and 408 the NOAEL parental was established at 300 mg/kg bw/day based on an adverse increase in trabecular bone in both sexes at 1000 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2df39ac6-39a0-445b-b0a0-956f6d10d3f8/documents/IUC5-e520ada0-cd01-480d-a158-cdb7d9ce6bae_74cfdac5-8887-4d66-8028-375ec225e7fc.html,,,,,, Piperonal,120-57-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2df39ac6-39a0-445b-b0a0-956f6d10d3f8/documents/IUC5-e520ada0-cd01-480d-a158-cdb7d9ce6bae_74cfdac5-8887-4d66-8028-375ec225e7fc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Piperonal,120-57-0,"After review of the available data, it has been concluded that heliotropin (piperonal) is of low acute toxicity following oral and dermal exposure.The reported oral LD50 value in rats is 2,700 mg/kg body weight. Clinical signs of systemic toxicity include excitation and tremors for several hours followed by depression and ataxia. Deaths occurred between 2 hours and 5 days following dosing.The reported dermal LD50 value in rats is > 5,000 mg/kg body weight, and no clinical signs of systemic toxicity or skin irritation or other dermal reactions were observed for up to 14 days following dermal administration.Information is not available on the acute inhalation toxicity of heliotropin (piperonal). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2df39ac6-39a0-445b-b0a0-956f6d10d3f8/documents/IUC5-3b3591ba-2be1-427d-86d0-f346d266eeaa_74cfdac5-8887-4d66-8028-375ec225e7fc.html,,,,,, Piperonal,120-57-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2df39ac6-39a0-445b-b0a0-956f6d10d3f8/documents/IUC5-3b3591ba-2be1-427d-86d0-f346d266eeaa_74cfdac5-8887-4d66-8028-375ec225e7fc.html,,oral,LD50,"2,700 mg/kg bw",no adverse effect observed, Piperonal,120-57-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2df39ac6-39a0-445b-b0a0-956f6d10d3f8/documents/IUC5-3b3591ba-2be1-427d-86d0-f346d266eeaa_74cfdac5-8887-4d66-8028-375ec225e7fc.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-hydroxyethyl methacrylate,868-77-9," Repeated dose toxicity of HEMA has been investigated in an OECD 422 combined repeated dose and reproductive toxicity study. A chronic study does not have to be performed, because, like MMA, the substances are rapidly metabolised, and by analogy to MMA ultimately metabolised to carbon dioxide and water. Therefore, as demonstrated in the case of MMA in carcinogenicity studies of up to 2 years duration, there is no concern for lesions due to accumulative toxicity. MMA data with different species and different application routes are used by read-across. For EG, the glycolic metabolite of HEMA, subchronic and chronic studies in rodents show toxicity with the kidneys as target organ.   Read across evaluation according to ECHA’s ReadAcrossAssessment Framework (RAAF) The metabolism from HEMA to its primary metabolites is well understood. The same is true for the further metabolism pathways of MAA and the alcohol metabolite EG, respectively (see chapter 5.2, ATSDR 1997/ 2008/ 2010, NTP 2004a, 2004b). The endpoint specific “scientific assessment” of the read across is thus “acceptable with a high level of confidence”, see the attached Read Across Justification (2022) and Category document (2019). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79f82d0f-2aad-4076-90be-4bc74bae6d01/documents/IUC5-4a4bc703-1554-4715-9f54-4ece3eac3b7a_540ca131-5bb5-46fa-9d6d-4f5e80c64e25.html,,,,,, 2-hydroxyethyl methacrylate,868-77-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79f82d0f-2aad-4076-90be-4bc74bae6d01/documents/IUC5-4a4bc703-1554-4715-9f54-4ece3eac3b7a_540ca131-5bb5-46fa-9d6d-4f5e80c64e25.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 2-hydroxyethyl methacrylate,868-77-9,"Acute oral toxicity: LD50 > 5000 mg/kgAcute dermal toxicity: LD50 > 5000 mg/kgAcute inhalation toxicity: no data available, no toxicity is expected 2-Hydroxyethyl methacrylate is of low acute oral toxicity (LD50 > 5000 mg/kg) (Sterner, Stiglic 1977). A study on dermal toxicity of HEMA is not available. The structurally very similar substance Hydroxypropyl methacrylate (CAS 27813-02-1) is of low dermal toxicity (LD50: > 5000 mg/kg) (Rohm & Haas, 1982). Due to the low vapour pressure of HEMA, inhalation is not an expected route of exposure. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79f82d0f-2aad-4076-90be-4bc74bae6d01/documents/IUC5-ab8924e2-aa7c-4445-aa4a-bfcf3ff3fce9_540ca131-5bb5-46fa-9d6d-4f5e80c64e25.html,,,,,, 2-hydroxyethyl methacrylate,868-77-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79f82d0f-2aad-4076-90be-4bc74bae6d01/documents/IUC5-ab8924e2-aa7c-4445-aa4a-bfcf3ff3fce9_540ca131-5bb5-46fa-9d6d-4f5e80c64e25.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, 2-hydroxyethyl methacrylate,868-77-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79f82d0f-2aad-4076-90be-4bc74bae6d01/documents/IUC5-ab8924e2-aa7c-4445-aa4a-bfcf3ff3fce9_540ca131-5bb5-46fa-9d6d-4f5e80c64e25.html,,dermal,LD50,">=5,000 mg/kg bw",no adverse effect observed, 2-[(2-methyl-1-oxoallyl)oxy]ethyl acetoacetate,21282-97-3,"A sub-chronic (90 days) oral toxicity study in the rat was performed during September 1989 until May 1990 according to OECD Guideline 408, Guideline EPA OTS 798.2650 and GLP. Groups of 10 male and 10 female rats were given 0, 50, 150, or 500 mg/kg of AAEM by oral gavage. The results of this oral gavage study indicate that the test item has no potential to produce toxic effects when administered to rats at dosage of 500 mg/kg/day. Based on the lack of treatment-related effects in clinical signs, ophthalmic examinations, feed consumption, weight gain, clinical pathology, organ weights, gross pathology, microscopic pathology, and FOB results, the no-observed-effect level (NOEL) for sub-chronic exposure to AAEM was considered to be 500 mg/kg/day for both male and female rats when administered 5 days per week for 13 weeks. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f94ccd8b-efcb-4b57-91d6-751578d3b94a/documents/IUC5-dcfbed12-1235-47b2-8130-c2ea02e761f6_3b180458-1171-435e-8a3d-07aedf3cf154.html,,,,,, 2-[(2-methyl-1-oxoallyl)oxy]ethyl acetoacetate,21282-97-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f94ccd8b-efcb-4b57-91d6-751578d3b94a/documents/IUC5-dcfbed12-1235-47b2-8130-c2ea02e761f6_3b180458-1171-435e-8a3d-07aedf3cf154.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat 2-[(2-methyl-1-oxoallyl)oxy]ethyl acetoacetate,21282-97-3,"Two acute toxicity studies were carried out for the oral and dermal route. In a study according to OECD Guideline 401 (Acute toxicity oral) the LD50 oral was determined to be greater than 5000 mg/kg bw. Testing by the inhalation route was waived as exposure of humans is unlikely taking in to account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The vapour pressure of LZ649 is 0.24 Pa and no particle size distribution study was performed as the substance is a liquid. Furthermore, the second likely route of human exposure is by dermal route. Therefore a dermal study was performed. On this basis an acute inhalation study is not required. In a study according to OECD Guideline 402 (Acute Dermal Toxicity) the LD50 dermal was determined to be greater than 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f94ccd8b-efcb-4b57-91d6-751578d3b94a/documents/IUC5-a4c02e4b-6625-44d2-b4b8-da3aef0c785e_3b180458-1171-435e-8a3d-07aedf3cf154.html,,,,,, 2-[(2-methyl-1-oxoallyl)oxy]ethyl acetoacetate,21282-97-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f94ccd8b-efcb-4b57-91d6-751578d3b94a/documents/IUC5-a4c02e4b-6625-44d2-b4b8-da3aef0c785e_3b180458-1171-435e-8a3d-07aedf3cf154.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-[(2-methyl-1-oxoallyl)oxy]ethyl acetoacetate,21282-97-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f94ccd8b-efcb-4b57-91d6-751578d3b94a/documents/IUC5-a4c02e4b-6625-44d2-b4b8-da3aef0c785e_3b180458-1171-435e-8a3d-07aedf3cf154.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Hematite (Fe2O3),1317-60-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52dbf196-14d6-4448-9640-dc80959dcbf4/documents/04c7ffab-01d0-43a6-a9f4-cc61c2ca3ca1_3162cb56-035b-44e6-9f79-2176b6c72381.html,,inhalation,LC50,2.2 mg/m3,, "Lawsonia inermis, ext.",84988-66-9," An acute oral toxicity study of Henna was performed in the Rat according to the OECD Guideline N°401 (1981). The calculated oral median lethal dose was > 2000 mg/kg bw. Other studies support this result. The other oral toxicity study informs that LD50 is 2000mg/kg bw. And LD50 is 570 -2000mg/kg bw for active substance (Lawsone, HNQ) An acute dermal toxicity: Median lethal dose for Henna was > 2000 mg/kg bw, even 5000 mg/lkg bw. Lawsonia inermis showed no irritative potential for the skin after a single occlusive application for 24 hours, when tested for acute dermal toxicity under the experimental conditions. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee059239-9341-462b-8b21-81fdac16c38e/documents/9fe634a1-5159-454f-92cd-18736532af0c_26bd5ae2-f07e-4eeb-9dae-46db66387f69.html,,,,,, "Decahydro-2,2,6,6,7,8,8,heptamethyl-2H-Indeno[4,5-b] furan",476332-65-7,"Oral: NOAEL = 150 mg/kg bw/day, rats (OECD TG 407 and OECD TG 421, GLP). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Two GLP compliant oral studies (OECD TG 407 and 421) were available, both assigned a Klimisch 1 rating, adequately covering this endpoint. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b352ecbf-55b6-49b5-a836-cd9160d62fd1/documents/229a6776-db6f-43d5-98a9-4d8cc78ed9e8_338c5aa4-58dd-4704-b314-99d5b2e42a23.html,,,,,, "Decahydro-2,2,6,6,7,8,8,heptamethyl-2H-Indeno[4,5-b] furan",476332-65-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b352ecbf-55b6-49b5-a836-cd9160d62fd1/documents/229a6776-db6f-43d5-98a9-4d8cc78ed9e8_338c5aa4-58dd-4704-b314-99d5b2e42a23.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Decahydro-2,2,6,6,7,8,8,heptamethyl-2H-Indeno[4,5-b] furan",476332-65-7,"- Oral LD50: >2500 mg/kg bw (OECD TG 423, GLP).- Inhalation LD50: > 6500 mg/m3 (route-to-route extrapolation from acute oral toxicity study).- Dermal LD50: >2000 mg/kg bw (OECD TG 402, GLP). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The one study available is adequate for covering this endpoint. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The one study available is adequate for covering this endpoint. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b352ecbf-55b6-49b5-a836-cd9160d62fd1/documents/IUC5-ca63533b-0687-4b9a-b033-00ad8890f9f4_338c5aa4-58dd-4704-b314-99d5b2e42a23.html,,,,,, "Decahydro-2,2,6,6,7,8,8,heptamethyl-2H-Indeno[4,5-b] furan",476332-65-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b352ecbf-55b6-49b5-a836-cd9160d62fd1/documents/IUC5-ca63533b-0687-4b9a-b033-00ad8890f9f4_338c5aa4-58dd-4704-b314-99d5b2e42a23.html,,oral,LD50,"> 2,500 mg/kg bw",no adverse effect observed, "Decahydro-2,2,6,6,7,8,8,heptamethyl-2H-Indeno[4,5-b] furan",476332-65-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b352ecbf-55b6-49b5-a836-cd9160d62fd1/documents/IUC5-ca63533b-0687-4b9a-b033-00ad8890f9f4_338c5aa4-58dd-4704-b314-99d5b2e42a23.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Heptanal,111-71-7," Oral repeated toxicity studies : There are : 1 -One key 13-week toxicity study performed with Heptanal according to GLP and OECD 408 (Bentz, 2015) where no significant findings were observed. The NOAEL was set at 1000 mg/kg/day. 2 -One supporting repeated Dose 28-day oral rat toxicity study was available (OECD 407) (Terrill 1990) - Read-across with heptanoic acid. Rat (female/male): NOAEL = 1750 mg/kg bw/day and LOAEL = 3500 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fae9754-84e3-4e50-96ea-e18a2a4ed8f3/documents/IUC5-c043528a-c816-49b8-a9e9-3bfc8374252e_f64ced3c-c60a-4dd7-a42f-99a41784066c.html,,,,,, Heptanal,111-71-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fae9754-84e3-4e50-96ea-e18a2a4ed8f3/documents/IUC5-c043528a-c816-49b8-a9e9-3bfc8374252e_f64ced3c-c60a-4dd7-a42f-99a41784066c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Heptanal,111-71-7,Inhalation: LC50 > 18.6 mg/l for female and male rats (similar to OECD Guideline 403).Oral: LD50 > 5000 mg/kg bw (similar to OECD Guideline 401).Dermal: no reliable study is available. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fae9754-84e3-4e50-96ea-e18a2a4ed8f3/documents/IUC5-2cde9125-5e66-4b10-b54b-974ebef8d160_f64ced3c-c60a-4dd7-a42f-99a41784066c.html,,,,,, Heptanal,111-71-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fae9754-84e3-4e50-96ea-e18a2a4ed8f3/documents/IUC5-2cde9125-5e66-4b10-b54b-974ebef8d160_f64ced3c-c60a-4dd7-a42f-99a41784066c.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Heptanal,111-71-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fae9754-84e3-4e50-96ea-e18a2a4ed8f3/documents/IUC5-2cde9125-5e66-4b10-b54b-974ebef8d160_f64ced3c-c60a-4dd7-a42f-99a41784066c.html,,inhalation,discriminating conc.,18.6 mg/m3,no adverse effect observed, Heptane,142-82-5, Repeated Dose Inhalation – NOAEC (systemic) ≥ 12470 mg/m3 for rats ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e8209f2-bc38-436a-a2df-3b922e1b8490/documents/d0329368-b9a9-4503-b5f9-fd1c51be9b59_d44cc870-f60e-4f66-ac17-6568b367eb1a.html,,,,,, Heptane,142-82-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e8209f2-bc38-436a-a2df-3b922e1b8490/documents/d0329368-b9a9-4503-b5f9-fd1c51be9b59_d44cc870-f60e-4f66-ac17-6568b367eb1a.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"12,470 mg/m3",,rat Heptane,142-82-5, Oral LD50 (rat) > 5000 mg/kg bw   Inhalation LC50 (rat) > 29.9 mg/L   Dermal LD50 (rabbit) > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e8209f2-bc38-436a-a2df-3b922e1b8490/documents/0cebeb0e-d659-4462-9e66-ec9ec9b58e0b_d44cc870-f60e-4f66-ac17-6568b367eb1a.html,,,,,, Heptane,142-82-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e8209f2-bc38-436a-a2df-3b922e1b8490/documents/0cebeb0e-d659-4462-9e66-ec9ec9b58e0b_d44cc870-f60e-4f66-ac17-6568b367eb1a.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Heptane,142-82-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e8209f2-bc38-436a-a2df-3b922e1b8490/documents/0cebeb0e-d659-4462-9e66-ec9ec9b58e0b_d44cc870-f60e-4f66-ac17-6568b367eb1a.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Heptane,142-82-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e8209f2-bc38-436a-a2df-3b922e1b8490/documents/0cebeb0e-d659-4462-9e66-ec9ec9b58e0b_d44cc870-f60e-4f66-ac17-6568b367eb1a.html,,inhalation,LC50,> 29.9 mg/L,no adverse effect observed, Heptan-1-ol,111-70-6,"Oral repeated toxicity : two key studies were available for evaluation of repeated exposure toxicity. NOAEL of 1000 mg/kg/day was recorded in both studies.- A subchronic 90 day study was performed in rats with the analogue Pentanol (equivalent to OECD 408)- Butterworth, 1978). Read across justification (see document attached in chapter 13): The read accross is based on the comparable pattern of the physicochemical, structural properties and toxicological profils between the two analogues (pentanol vs. heptanol). Indeed, comparative NOAELs were observed in the repeated exposure study obtained in the OECD 422 with Heptanol (at least 28 days exposure for males and females (Spézia, 2012)) showing low order of toxicity (NOAEL= 1000 mg/kg/day) as well as in the 90 day subchronic study performed with pentanol (Butterworth, 1978), see also REACH disseminated dossiers). Based on the available data on aliphatic alcohols, it is shown that there is an inverse relationship between chain length and toxicity. The shorter chain alcohol tends to induce more pronounced effects when compared to materials with a longer chain length (i.e irritant property). We considered therefore that the 90 days study performed wth pentanol represented a worst case for assessment of heptanol repeated toxicity exposureIt was therefore considered that the use of this latter study for evaluation of the subchronic evaluation of Heptanol was justified. Indeed the same pattern of toxicity profile was obtained confirming the low order of toxicity of this aliphatic alcohols analogue category.Furthermore a SIDS on aliphatic alcohols category (SIAM 22, 2006) support the fact that the family of aliphatic alcohols is of low order of toxicity (see justification for read across, attached document in section 13).- An oral repeated dose toxicity study combined with the reproductive test (OECD 422) was perfomed with Heptanol in 2012 (Spézia, 2012) with a NOAEL for parental toxicity at 1000 mg/kg/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ae6c43cb-e4a3-4b76-8238-4f6460c157ed/documents/IUC5-da4c441a-6cd5-4d41-aec5-c35663894bbd_d716a2a2-67c3-43e9-bf0d-9739659e14d7.html,,,,,, Heptan-1-ol,111-70-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ae6c43cb-e4a3-4b76-8238-4f6460c157ed/documents/IUC5-da4c441a-6cd5-4d41-aec5-c35663894bbd_d716a2a2-67c3-43e9-bf0d-9739659e14d7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Heptan-1-ol,111-70-6,"There are an acute oral and dermal toxicity study performed in rats and rabbits, respectively (R. Truhaut, 1974). An acute inhalation study in rats was perfomed. The studies designs were comparable to respective guideline studies.LD50 oral (rats) : approx 5500 mg/kgLD50 dermal (rabbits) >2000 mg/kgLC0 (rats)=7.4 mg/m3 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae6c43cb-e4a3-4b76-8238-4f6460c157ed/documents/IUC5-591a2b09-447f-438b-b027-25a20ebab418_d716a2a2-67c3-43e9-bf0d-9739659e14d7.html,,,,,, Heptan-1-ol,111-70-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae6c43cb-e4a3-4b76-8238-4f6460c157ed/documents/IUC5-591a2b09-447f-438b-b027-25a20ebab418_d716a2a2-67c3-43e9-bf0d-9739659e14d7.html,,oral,LD50,"5,500 mg/kg bw",, Heptan-1-ol,111-70-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae6c43cb-e4a3-4b76-8238-4f6460c157ed/documents/IUC5-591a2b09-447f-438b-b027-25a20ebab418_d716a2a2-67c3-43e9-bf0d-9739659e14d7.html,,dermal,discriminating dose,"2,000 mg/kg bw",, Heptan-1-ol,111-70-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae6c43cb-e4a3-4b76-8238-4f6460c157ed/documents/IUC5-591a2b09-447f-438b-b027-25a20ebab418_d716a2a2-67c3-43e9-bf0d-9739659e14d7.html,,inhalation,discriminating conc.,7.4 mg/m3,, Hexadecane,544-76-3, Repeated Dose Oral 90d - NOAEL ≥ 500 mg/Kg bw/day for rats (OECD 408); BMDL = 1857 mg/Kg bw/day. Repeated Dose Inhalation 90d – NOAEC ≥ 6000 mg/m3 for rats (similar to OECD TG 413) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8ce92b4-e729-4aa2-9b68-e837d076e9b8/documents/d0fe5ca7-a313-4fef-b109-b6a45ed464b6_fefd15f7-196d-43d7-99fe-1561106bd98e.html,,,,,, Hexadecane,544-76-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8ce92b4-e729-4aa2-9b68-e837d076e9b8/documents/d0fe5ca7-a313-4fef-b109-b6a45ed464b6_fefd15f7-196d-43d7-99fe-1561106bd98e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Hexadecane,544-76-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8ce92b4-e729-4aa2-9b68-e837d076e9b8/documents/d0fe5ca7-a313-4fef-b109-b6a45ed464b6_fefd15f7-196d-43d7-99fe-1561106bd98e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"6,000 mg/m3",,rat Hexadecane,544-76-3, Oral LD50 (rat) > 5000 mg/Kg bw Inhalation LC50 (rat) >5991 mg/m³ Dermal LD50 (rabbit) > 2000 mg/Kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8ce92b4-e729-4aa2-9b68-e837d076e9b8/documents/462595da-e35e-4933-8786-845d8126a13a_fefd15f7-196d-43d7-99fe-1561106bd98e.html,,,,,, Hexadecane,544-76-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8ce92b4-e729-4aa2-9b68-e837d076e9b8/documents/462595da-e35e-4933-8786-845d8126a13a_fefd15f7-196d-43d7-99fe-1561106bd98e.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Hexadecane,544-76-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8ce92b4-e729-4aa2-9b68-e837d076e9b8/documents/462595da-e35e-4933-8786-845d8126a13a_fefd15f7-196d-43d7-99fe-1561106bd98e.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Hexadecane,544-76-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8ce92b4-e729-4aa2-9b68-e837d076e9b8/documents/462595da-e35e-4933-8786-845d8126a13a_fefd15f7-196d-43d7-99fe-1561106bd98e.html,,inhalation,LC50,"> 5,991 mg/m3",no adverse effect observed, Oxacycloheptadecan-2-one,109-29-5," In the GLP-compliant OECD guideline 422 study with rats, no adverse effects were observed at the highest tested dose of 1000 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/210968a1-716a-4c9f-b2a4-50b06fdff447/documents/a9346138-41cf-466b-b485-5dc2fc75a2bf_097f7d7c-1f6a-4634-8ffb-54cfac666893.html,,,,,, Oxacycloheptadecan-2-one,109-29-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/210968a1-716a-4c9f-b2a4-50b06fdff447/documents/a9346138-41cf-466b-b485-5dc2fc75a2bf_097f7d7c-1f6a-4634-8ffb-54cfac666893.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Oxacycloheptadecan-2-one,109-29-5, Oxacycloheptadecan-2-one is not acutely toxic by oral and dermal route. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/210968a1-716a-4c9f-b2a4-50b06fdff447/documents/a18f6eb8-00bb-4cda-81e0-5408423e9775_097f7d7c-1f6a-4634-8ffb-54cfac666893.html,,,,,, Oxacycloheptadecan-2-one,109-29-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/210968a1-716a-4c9f-b2a4-50b06fdff447/documents/a18f6eb8-00bb-4cda-81e0-5408423e9775_097f7d7c-1f6a-4634-8ffb-54cfac666893.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Oxacycloheptadecan-2-one,109-29-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/210968a1-716a-4c9f-b2a4-50b06fdff447/documents/a18f6eb8-00bb-4cda-81e0-5408423e9775_097f7d7c-1f6a-4634-8ffb-54cfac666893.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Hexadecene,26952-14-7," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df8a3565-5775-4560-9e1d-3fbb2b6e312b/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_66c23009-4d3c-4457-8372-8fadab1fd4dd.html,,,,,, Hexadecene,26952-14-7,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df8a3565-5775-4560-9e1d-3fbb2b6e312b/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_66c23009-4d3c-4457-8372-8fadab1fd4dd.html,,,,,, "3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indene",4488-57-7,"There are no data for TCDE. Considering the read-across substance, DCPD, oral and inhalation exposure resulted in nephrotoxicity (alterations in renal function and kidney morphology) in male rats only and characteristic of hyaline droplet nephropathy, which is not relevant for human risk assessment. Other changes which were seen in male rats in all groups (including controls) were characteristic of chronic glomerulonephropathy. Mortality was seen in rats dosed with 100 mg/kg/day orally and in mice exposed to 51 ppm by inhalation. Apart from the effects on the kidney in (male rats only), there were few histopathological changes. Single cell necrosis in the liver and fatty changes in the adrenal glands were seen in the oral rat study only. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1854b42-4f77-40a8-a2a4-cdf2604c70b0/documents/IUC5-d2a2f8f3-35f5-40e3-87c0-5f76e37d7597_fae3d71f-0ed1-4b27-b570-98d2779f37be.html,,,,,, "3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indene",4488-57-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1854b42-4f77-40a8-a2a4-cdf2604c70b0/documents/IUC5-d2a2f8f3-35f5-40e3-87c0-5f76e37d7597_fae3d71f-0ed1-4b27-b570-98d2779f37be.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,4 mg/kg bw/day,, "3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indene",4488-57-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1854b42-4f77-40a8-a2a4-cdf2604c70b0/documents/IUC5-d2a2f8f3-35f5-40e3-87c0-5f76e37d7597_fae3d71f-0ed1-4b27-b570-98d2779f37be.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,27.6 mg/m3,, "3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indene",4488-57-7,"3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indene (TCDE) is of slight - moderate acute toxicity by the oral and inhalation routes (oral LD50 670 mg/kg, inhalation 4 hour LC50 2,750 mg/m3) and is practically non-toxic by the dermal route (dermal LD50 > 2000 mg/kg). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1854b42-4f77-40a8-a2a4-cdf2604c70b0/documents/IUC5-2ebacf69-3338-4896-b5cd-c26abbee003a_fae3d71f-0ed1-4b27-b570-98d2779f37be.html,,,,,, "3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indene",4488-57-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1854b42-4f77-40a8-a2a4-cdf2604c70b0/documents/IUC5-2ebacf69-3338-4896-b5cd-c26abbee003a_fae3d71f-0ed1-4b27-b570-98d2779f37be.html,,oral,LD50,670 mg/kg bw,, "3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indene",4488-57-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1854b42-4f77-40a8-a2a4-cdf2604c70b0/documents/IUC5-2ebacf69-3338-4896-b5cd-c26abbee003a_fae3d71f-0ed1-4b27-b570-98d2779f37be.html,,dermal,LD50,"2,000 mg/kg bw",, "3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indene",4488-57-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1854b42-4f77-40a8-a2a4-cdf2604c70b0/documents/IUC5-2ebacf69-3338-4896-b5cd-c26abbee003a_fae3d71f-0ed1-4b27-b570-98d2779f37be.html,,inhalation,LC50,"2,750 mg/m3",, "3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indenyl propionate",68912-13-0,The repeated dose toxicity of Cyclaprop is based on data of two structural analogues: Cyclacet and Cyclobutanate - Key study: Cyclacet 90-day rat NOAEL ≥1500 mg/kg bw/day (OECD 408) - Supporting study: Cyclacet systemic toxicity in Reproductive/Developmental Toxicity screening study (OECD TG 421) >=1000 mg/kg bw. - Supporting study: Cyclobutanate 28 -day rat NOAEL ≥ 1000 mg/kg bw (OECD 407). ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad6af117-ba59-4878-b4e8-3a24f37bc721/documents/IUC5-6ee4c20f-8fc4-448c-94e1-97b23d81acf3_adbd3112-5f39-42fa-a236-fb567e586f1d.html,,,,,, "3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indenyl propionate",68912-13-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad6af117-ba59-4878-b4e8-3a24f37bc721/documents/IUC5-6ee4c20f-8fc4-448c-94e1-97b23d81acf3_adbd3112-5f39-42fa-a236-fb567e586f1d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat "3a,4,5,6,7,7a-hexahydro-4,7-methano-1H-indenyl propionate",68912-13-0,"Acute oral toxicity: LD50 >5000 mg/kg bw (similar to OECD TG 401, limit test) Acute dermal toxicity: LD50 >5000 mg/kg bw (similar to OECD TG 402, limit test) Acute inhalation toxicity: LD50: >35000 mg/m3 (calculated using route to route extrapolation from the acute oral toxicity results) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad6af117-ba59-4878-b4e8-3a24f37bc721/documents/IUC5-a882b975-fb34-4f74-872b-adae3b602d36_adbd3112-5f39-42fa-a236-fb567e586f1d.html,,,,,, "(2S)-1,3,4,5,6,7-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalene",1135-66-6,"Repeated dose toxicity: Oral   The no observed adverse effect level (NOAEL) was considered to be 1125 mg/kg body weight/day for the test chemical when administered orally by gavage to male and female Sprague-Dawley rats.   Repeated dose toxicity: Inhalation   The repeated dose inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0412 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.   Repeated dose toxicity: Dermal   The acute dermal toxicity value for(2S)-1,3,4,5,6,7-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalene (CAS no 1135-66-6)(as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93c2480b-e965-4ec1-aaec-4f5e803723d2/documents/a1955c32-e479-4f7f-96ff-9ebba015f293_7b3b8721-2227-401b-b692-ad08f17d3539.html,,,,,, "(2S)-1,3,4,5,6,7-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalene",1135-66-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93c2480b-e965-4ec1-aaec-4f5e803723d2/documents/a1955c32-e479-4f7f-96ff-9ebba015f293_7b3b8721-2227-401b-b692-ad08f17d3539.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,125 mg/kg bw/day",,rat "(2S)-1,3,4,5,6,7-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalene",1135-66-6," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is 6160 mg/kg bw. The study concluded that LD50 is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0412 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >5000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93c2480b-e965-4ec1-aaec-4f5e803723d2/documents/8adedd3e-f9be-43d0-83f1-acba40ab0d24_7b3b8721-2227-401b-b692-ad08f17d3539.html,,,,,, "(2S)-1,3,4,5,6,7-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalene",1135-66-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93c2480b-e965-4ec1-aaec-4f5e803723d2/documents/8adedd3e-f9be-43d0-83f1-acba40ab0d24_7b3b8721-2227-401b-b692-ad08f17d3539.html,,oral,LD50,"6,160 mg/kg bw",no adverse effect observed, "(2S)-1,3,4,5,6,7-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalene",1135-66-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93c2480b-e965-4ec1-aaec-4f5e803723d2/documents/8adedd3e-f9be-43d0-83f1-acba40ab0d24_7b3b8721-2227-401b-b692-ad08f17d3539.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "(2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one",29461-13-0," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e0af88f-5573-4fe2-b2bf-403c72480801/documents/fc8f26a3-bea5-4382-895c-68d6a1c42cd7_b3f3ac46-cbf2-4620-bf76-398c75c4b9b1.html,,,,,, "(2α,4aα,8β)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one",29461-13-0,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e0af88f-5573-4fe2-b2bf-403c72480801/documents/fc8f26a3-bea5-4382-895c-68d6a1c42cd7_b3f3ac46-cbf2-4620-bf76-398c75c4b9b1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3a,4,5,6,7,7a-hexahydro-5-methoxy-4,7-methano-1H-indene",53018-24-9," Acute Oral Toxicity, Edwards (1985) Under the conditions of the study the acute oral LD50 of the test material was between 2.0 and 5.0 mL/kg bodyweight (equivalent to between 2020 and 5050 mg/kg when taking the density of the test material as 1.01 as detailed in the study report). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4fc1f6b-7e29-4951-b480-854bd6141eaf/documents/e1c8d358-1188-4c5b-a294-997449fd5a46_ce980bd9-278c-49ab-867f-23d35a661151.html,,,,,, "1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran",1222-05-5,"NOAEL: 150 mg/kg bw derived from an OECD TG 408 (GLP) study. NOAEL: 91.7 mg/kg bw derived from an OECD TG 443 (GLP) study Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The quality of the database is high because the information fulfils the REACH requirements: a 90-day study and an extended one generation test according to OECD guidelines (and GLP) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4cb6cabd-6296-4a89-8f13-21e5bc892bcd/documents/IUC5-15cb476a-42c0-4541-961d-ee6a9d80696f_6d8b44b3-9782-460f-910f-ea01b36559a9.html,,,,,, "1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran",1222-05-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4cb6cabd-6296-4a89-8f13-21e5bc892bcd/documents/IUC5-15cb476a-42c0-4541-961d-ee6a9d80696f_6d8b44b3-9782-460f-910f-ea01b36559a9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,91.7 mg/kg bw/day,,rat "1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran",1222-05-5,Acute oral toxicity: LD50 is >3000 mg/kg bw in an OECD TG 423 Acute dermal toxicity: LD50 is >3250 mg/kg bw in an OECD TG 402 Acute inhalation toxicity 4hour LC50 is >5.04 mg/L in an OECD TG 403 ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4cb6cabd-6296-4a89-8f13-21e5bc892bcd/documents/IUC5-fc62cf9b-8a19-4cc5-98eb-50cc7c58a17f_6d8b44b3-9782-460f-910f-ea01b36559a9.html,,,,,, "1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran",1222-05-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4cb6cabd-6296-4a89-8f13-21e5bc892bcd/documents/IUC5-fc62cf9b-8a19-4cc5-98eb-50cc7c58a17f_6d8b44b3-9782-460f-910f-ea01b36559a9.html,,oral,LD50,"> 3,000 mg/kg bw",no adverse effect observed, "1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran",1222-05-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4cb6cabd-6296-4a89-8f13-21e5bc892bcd/documents/IUC5-fc62cf9b-8a19-4cc5-98eb-50cc7c58a17f_6d8b44b3-9782-460f-910f-ea01b36559a9.html,,dermal,LD50,"> 3,250 mg/kg bw",no adverse effect observed, "1,3,4,6,7,8-hexahydro-4,6,6,7,8,8-hexamethylindeno[5,6-c]pyran",1222-05-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4cb6cabd-6296-4a89-8f13-21e5bc892bcd/documents/IUC5-fc62cf9b-8a19-4cc5-98eb-50cc7c58a17f_6d8b44b3-9782-460f-910f-ea01b36559a9.html,,inhalation,LC50,"> 5,040 mg/m3",no adverse effect observed, "2-hydroxyethanesulphonic acid, compound with 4,4'-[hexane-1,6-diylbis(oxy)]bis[benzenecarboxamidine] (2:1)",659-40-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): LD50 cut-off value ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf593c2d-ca85-46b8-abc0-426640b11b12/documents/b4f5d8e3-4858-4bb5-8604-67aff45ce130_3beef227-8a13-438b-ba2d-c35936aedcb1.html,,,,,, "2-hydroxyethanesulphonic acid, compound with 4,4'-[hexane-1,6-diylbis(oxy)]bis[benzenecarboxamidine] (2:1)",659-40-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf593c2d-ca85-46b8-abc0-426640b11b12/documents/b4f5d8e3-4858-4bb5-8604-67aff45ce130_3beef227-8a13-438b-ba2d-c35936aedcb1.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Hexanal,66-25-1,"Short-term toxicity studies (4 weeks) on hexanal in Sprague-Dawley rats (10 animals per sex per dose) were carried out similar to OECD TG 407. Hexanal was administered at the doses 1, 10, 100, and 1000 mg/L in the drinking water. The actual doses received were 0.1 - 95.7 mg/kg bw/day for female and 0.1 - 124.7 mg/kg bw/day for male rats. It was shown that hexanal produced no overt toxic effects. Although treatment-related morphological changes were observed in the highest dose groups; these were considered to be mild and adaptative in nature, and could not be related to any functional changes. The only biochemical parameter affected by treatment was the reduced LDH activity in hexanal treated female rats. However, the biological significance of this change is uncertain. The growth rate and hematological parameter were not affected (Komsta et al. 1988).   Repeated Dose toxicity: Subacute study in Wistar rats, m/f, 42 resp. 51-57 days, oral: gavage (OECD TG 422, GLP): NOAEL = 1000 mg/kg Hexanal was repeatedly administered orally (by gavage) to rats at doses of 0, 100, 300 and 1000 mg/kg bw/day to Wistar rats (12/sex/group) over 42 resp. 51-57 days. There was no test item related mortality or clinical signs at any dose level (100, 300 and 1000 mg/kg bw/day). No test-item related effects were noted on Body weight and body weight gain, Food consumption, Hematology and blood coagulation, Clinical chemistry or Serum thyroid hormones. Necropsy revealed no macroscopic findings related to the effect of the test item at any dose level, no effects on organ weights were noted. Histopathological examinations did not indicate any toxic or other test item related lesions in the investigated organs of selected male and female animals at 1000 mg/kg bw/day. The NOAEL for systemic toxicity of male/ female rats was determined to 1000 mg/kg bw/day (Szakonyiné 2019). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e2687cc-a3b0-410a-b038-782737bd6eb4/documents/a7c9513d-d447-4eeb-80cd-c350713c52cc_2a0cd70d-ac76-45bb-b914-85dc020762e4.html,,,,,, Hexanal,66-25-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e2687cc-a3b0-410a-b038-782737bd6eb4/documents/a7c9513d-d447-4eeb-80cd-c350713c52cc_2a0cd70d-ac76-45bb-b914-85dc020762e4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Hexanal,66-25-1," oral non-guideline standard acute method, rat, single dose (gavage), 14 days, LD50 = 7703 mg/kg bw dermal non-guideline standard acute method, rabbit, single dose (24 h occlusive), 14 days, LD50 = 8100 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e2687cc-a3b0-410a-b038-782737bd6eb4/documents/8379a437-8695-460e-a1c7-729c478329c3_2a0cd70d-ac76-45bb-b914-85dc020762e4.html,,,,,, Hexanal,66-25-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e2687cc-a3b0-410a-b038-782737bd6eb4/documents/8379a437-8695-460e-a1c7-729c478329c3_2a0cd70d-ac76-45bb-b914-85dc020762e4.html,,oral,LD50,"7,703 mg/kg bw",no adverse effect observed, Hexanal,66-25-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e2687cc-a3b0-410a-b038-782737bd6eb4/documents/8379a437-8695-460e-a1c7-729c478329c3_2a0cd70d-ac76-45bb-b914-85dc020762e4.html,,dermal,LD50,"8,100 mg/kg bw",no adverse effect observed, N-hexane,110-54-3, Repeated Dose Oral 90d – NOAEL (systemic) = 40 mg/kg bw for rats   Repeated Dose Inhalation 90d – LOAEC (systemic) = 1760 mg/m3 for rats ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9504e62-3f6e-4bd0-9859-a722bbd02da6/documents/2a51cd1f-b910-4a2e-87c2-1bff6c7de066_9509a4dd-b273-4172-83f1-16f444789efd.html,,,,,, N-hexane,110-54-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9504e62-3f6e-4bd0-9859-a722bbd02da6/documents/2a51cd1f-b910-4a2e-87c2-1bff6c7de066_9509a4dd-b273-4172-83f1-16f444789efd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat N-hexane,110-54-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9504e62-3f6e-4bd0-9859-a722bbd02da6/documents/2a51cd1f-b910-4a2e-87c2-1bff6c7de066_9509a4dd-b273-4172-83f1-16f444789efd.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,"1,760 mg/m3",,mouse N-hexane,110-54-3, Oral LD50 (rat) = 16000 mg/kg (24 mL/kg)   Inhalation LC50 (rat) > 17600 mg/m3 (5000 ppm)   Dermal LD50 (rabbit) > 3350 mg/kg (5 mL/kg) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9504e62-3f6e-4bd0-9859-a722bbd02da6/documents/63227d30-b0d5-4860-b8eb-a020cc4c266a_9509a4dd-b273-4172-83f1-16f444789efd.html,,,,,, N-hexane,110-54-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9504e62-3f6e-4bd0-9859-a722bbd02da6/documents/63227d30-b0d5-4860-b8eb-a020cc4c266a_9509a4dd-b273-4172-83f1-16f444789efd.html,,oral,LD50,"ca.16,000 mg/kg bw",adverse effect observed, N-hexane,110-54-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9504e62-3f6e-4bd0-9859-a722bbd02da6/documents/63227d30-b0d5-4860-b8eb-a020cc4c266a_9509a4dd-b273-4172-83f1-16f444789efd.html,,dermal,LD50,"> 3,350 mg/kg bw",no adverse effect observed, N-hexane,110-54-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9504e62-3f6e-4bd0-9859-a722bbd02da6/documents/63227d30-b0d5-4860-b8eb-a020cc4c266a_9509a4dd-b273-4172-83f1-16f444789efd.html,,inhalation,LC50,"> 17,600 mg/m3",no adverse effect observed, "Hexane-1,6-diol",629-11-8,"1, 6 Hexan diol is of low toxicity after repeated oral exposure.- oral: NOEL = 1000 mg/kg bw (OECD 407), NOAEL = 400 mg/kg bw (OECD 408) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de43451e-2f8a-4518-a68f-693c461373e8/documents/IUC5-552cc6c6-926a-4eb3-aeaf-0044e9c255e0_fb8cd825-674a-46d9-8f4d-b294ddbf4ad0.html,,,,,, "Hexane-1,6-diol",629-11-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de43451e-2f8a-4518-a68f-693c461373e8/documents/IUC5-552cc6c6-926a-4eb3-aeaf-0044e9c255e0_fb8cd825-674a-46d9-8f4d-b294ddbf4ad0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat "Hexane-1,6-diol",629-11-8,"1,6 Hexanediol are of low acute toxicity via all routes of exposure.The following lethal doses after acute exposures have been determined in the key studies- oral: LD50 = ca. 3000 mg/kg bw- inhalative = no mortalities within 8 h (IRT; ca. 3.3 mg/l)- dermal: LD50 > 2500 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de43451e-2f8a-4518-a68f-693c461373e8/documents/IUC5-db986ebc-5cd4-496c-b0cb-fdf6232fdb5e_fb8cd825-674a-46d9-8f4d-b294ddbf4ad0.html,,,,,, "1,6-hexanediyl bismethacrylate",6606-59-3," No data are available for 1,6-HDDMA. However, data from the analogous substance 1,4 -BDDMA and metabolites (MAA/MMA and 1,6 -HD) allow the evaluation of repeated dose hazard of 1,6 -HDDMA after oral and inhalative exposure. Read-across to the metabolites is justified by the fact that carboxylesterases are ubiquitous in the body and half-lifes of the other category substances are only a few minutes (see category document, chapter 5.1). In the body, methyl methacrylate hydrolyses rapidly to methacrylic acid and thus serves as methacrylic acid donor in several test systems investigating systemic effects. For hazard assessment purposes of 1,6 -HDDMA however, a subacute study with the analogous substance 1,4-BDDMA is used as starting point for DNEL calculation.   Following data were considered for read across: Subacute (33-40 day) study; oral (gavage); rat, m/f (OECD guideline 422, GLP): NOAEL = 300 mg/kg bw/d due to liver and stomach findings; read-across from the analogous substance 1,4-BDDMA (RTC 2013) Subchronic (90 d) study; inhalation vapour, rat, m/f (OECD guideline 413, GLP); NOAEClocal= 100 ppm (352 mg/m3) due to local irritation effects in the respiratory epithelium; NOAECsystemic= 100 ppm (352 mg/m3) due to reduced bw gain; read-across from the metabolite MAA (BASF 2008) Chronic (2 yrs) study; oral (drinking water), rat, m/f (pre-guideline, pre-GLP): NOAEL ≥ 2000 ppm (=124 mg/kg bw/d in males and 164 mg/kg bw/d in females); read-across from the metabolite donor substance MMA (Borzelleca 1964) Chronic/ Carcinogenicity (2 yrs) study; inhalation (vapour), rat, m/f (comp. to OECD guideline 453, non-GLP): LOAEClocal= 100 ppm (ca. 416 mg/m3) due to nasal lesions; NOAECsystemic= 400 ppm (ca. 1640 mg/m3) due to reduced bw gain read-across from the metabolite donor substance MMA (Lomax 1997) Chronic/ Carcinogenicity (2 yrs) study; inhalation (vapour), rat, m/f (NTP protocol, GLP): LOAEClocal= 250 ppm for female rats and 500 ppm for male rats due to nasal lesions; NOAECsystemic≥ 500 ppm for female rats and ≥ 1000 ppm male rats; read-across from the metabolite donor substance MMA (NTP 1986) Subacute (28 d) study; oral (gavage), rat, m/f (OECD guideline 407, GLP); NOEL = 1000 mg/kgbw/d; read across from the alcohol metabolite 1,6 -HD (OECD 2002) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff1d8c25-d2fe-4523-992c-a70315a2fc3c/documents/3ee526f4-130b-4407-af6a-c48a89948c2a_e9e989df-4796-4310-8388-16d622a00155.html,,,,,, "1,6-hexanediyl bismethacrylate",6606-59-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff1d8c25-d2fe-4523-992c-a70315a2fc3c/documents/3ee526f4-130b-4407-af6a-c48a89948c2a_e9e989df-4796-4310-8388-16d622a00155.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "1,6-hexanediyl bismethacrylate",6606-59-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff1d8c25-d2fe-4523-992c-a70315a2fc3c/documents/3ee526f4-130b-4407-af6a-c48a89948c2a_e9e989df-4796-4310-8388-16d622a00155.html,Chronic toxicity – systemic effects,inhalation,NOAEC,416 mg/m3,,rat "1,6-hexanediyl bismethacrylate",6606-59-3,"1,6-Hexanediol dimethacrylate is of low acute oral toxicity. LD50 is higher than 2000 mg/kg bw in rats. Acute oral toxicity: LD50 (rat, combined) > 2000 mg/kg bw; OECD Guideline 423, GLP (Klimisch score = 1)Acute inhalation toxicity: no relevant route of exposureAcute dermal toxicity: no relevant route of exposure ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff1d8c25-d2fe-4523-992c-a70315a2fc3c/documents/IUC5-75e91819-5420-4099-9e1b-201884af699c_e9e989df-4796-4310-8388-16d622a00155.html,,,,,, "1,6-hexanediyl bismethacrylate",6606-59-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff1d8c25-d2fe-4523-992c-a70315a2fc3c/documents/IUC5-75e91819-5420-4099-9e1b-201884af699c_e9e989df-4796-4310-8388-16d622a00155.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Hex-1-ene,592-41-6," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cebcd712-1bea-4249-a4dc-545378b8e132/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_1b00b0b7-98ae-48d2-8797-3b911c97fd95.html,,,,,, Hex-1-ene,592-41-6,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cebcd712-1bea-4249-a4dc-545378b8e132/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_1b00b0b7-98ae-48d2-8797-3b911c97fd95.html,,,,,, Hexyl acetate,142-92-7,"Subchronic exposure of rats to n-butyl acetate vapour resulted in acute, transient signs of reduced activity levels during exposure to 1500 and 3000 ppm. Decreased body weight and feed consumption were noted for the 1500 and 3000 ppm groups, but there was no systemic or organ-specific toxicity. Signs of upper respiratory tract irritation were seen in the nasal passages of 1500 and 3000 ppm animals, but there was no evidence of pulmonary toxicity. The no-observed-adverse-effect concentration (NOAEC) for this study is considered to be 500 ppm (2.4 mg/L). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2db21f0d-68df-4e32-ac4c-81c3004b4855/documents/IUC5-6316600f-40c5-4094-89f2-f6d5181a93fd_d5396ae4-8651-4e6e-80f3-3abfd3358fc8.html,,,,,, Hexyl acetate,142-92-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2db21f0d-68df-4e32-ac4c-81c3004b4855/documents/IUC5-6316600f-40c5-4094-89f2-f6d5181a93fd_d5396ae4-8651-4e6e-80f3-3abfd3358fc8.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"2,400 mg/m3",,rat Hexyl acetate,142-92-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2db21f0d-68df-4e32-ac4c-81c3004b4855/documents/IUC5-6316600f-40c5-4094-89f2-f6d5181a93fd_d5396ae4-8651-4e6e-80f3-3abfd3358fc8.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"2,400 mg/m3",adverse effect observed,rat Hexyl acetate,142-92-7,"Data are available for the acute toxicity of hexyl acetate following oral, dermal and inhalation exposure.  Low toxicity is demonstrated for all exposure routes. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2db21f0d-68df-4e32-ac4c-81c3004b4855/documents/IUC5-698b9295-5409-472a-bfa3-9d13254cfbed_d5396ae4-8651-4e6e-80f3-3abfd3358fc8.html,,,,,, Hexyl acetate,142-92-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2db21f0d-68df-4e32-ac4c-81c3004b4855/documents/IUC5-698b9295-5409-472a-bfa3-9d13254cfbed_d5396ae4-8651-4e6e-80f3-3abfd3358fc8.html,,oral,LD50,"41,500 mg/kg bw",no adverse effect observed, Hexyl acetate,142-92-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2db21f0d-68df-4e32-ac4c-81c3004b4855/documents/IUC5-698b9295-5409-472a-bfa3-9d13254cfbed_d5396ae4-8651-4e6e-80f3-3abfd3358fc8.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Hexyl acetate,142-92-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2db21f0d-68df-4e32-ac4c-81c3004b4855/documents/IUC5-698b9295-5409-472a-bfa3-9d13254cfbed_d5396ae4-8651-4e6e-80f3-3abfd3358fc8.html,,inhalation,LC50,"15,300 mg/m3",no adverse effect observed, Hexan-1-ol,111-27-3," A reliable 13-week dietary study in rats using hexan-1-ol reported a NOAEL of 1127 mg/kg (Scientific Associates Inc., 1966a). No adverse effects were noted at any of the dose levels administered during the study. The results of this key study are supported by the reliable 3-week feeding study in rats which reported a NOAEL of approximately 1000 mg/kg bw/day (Moody and Reddy, 1978, 1982). In addition, a 13-week study in dogs reported a NOAEL for 370 mg/kg bw/day for male dogs and 435 mg/kg bw/day for female dogs (Scientific Associates, 1966b). Although this study had some methodology discrepancies, it is still considered to be reliable and can be used as supporting data. A reliability 4 six-month inhalation study to vapours of 118 mg/m3 (28.3 ppm) hexyl alcohol  in rabbits revealed ultrastructural  changes in the photoreceptor cells and Muller fibres. Based on the information provided, this study is considered to be of limited value. In addition, in a 90-day repeated dose dermal study (Wil Research, 1995) in rats, a multi-constituent solution containing circa 50% decan-1-ol and 45% octan-1-ol (semi-occluded conditions) reported no systemic effects at the highest dose tested. The study did however gave rise to marked dermal irritative effect. It is however important to take into account the different test protocol that was used, that is a 90-day repeated dose dermal study (6 hours/day for 5 days/week) compared to a standard 4-hour dermal irritation study and the different species (rats instead of rabbit) and test duration (90 days vs. 4 hours). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e54d1ca9-741f-48fd-826c-e4b69f34303f/documents/8b10f5a2-dd3c-40b8-93e6-3ea5e5dfcc82_8bdf963b-d49d-457a-a055-22098926bb1b.html,,,,,, Hexan-1-ol,111-27-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e54d1ca9-741f-48fd-826c-e4b69f34303f/documents/8b10f5a2-dd3c-40b8-93e6-3ea5e5dfcc82_8bdf963b-d49d-457a-a055-22098926bb1b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,127 mg/kg bw/day",,rat Hexan-1-ol,111-27-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e54d1ca9-741f-48fd-826c-e4b69f34303f/documents/8b10f5a2-dd3c-40b8-93e6-3ea5e5dfcc82_8bdf963b-d49d-457a-a055-22098926bb1b.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat Hexan-1-ol,111-27-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e54d1ca9-741f-48fd-826c-e4b69f34303f/documents/8b10f5a2-dd3c-40b8-93e6-3ea5e5dfcc82_8bdf963b-d49d-457a-a055-22098926bb1b.html,Repeated dose toxicity – local effects,dermal,LOAEL,2.8 mg/cm2,adverse effect observed,rat Hexan-1-ol,111-27-3," The key acute oral toxicity study, conducted according to a guideline similar to the now-deleted OECD Test Guideline 401 but prior to GLP compliance, reports an LD50 value of 3210 mg/kg in rat (Scientific Associates Inc 1965). The key acute inhalation toxicity study, which was conducted prior to OECD Test Guidelines and GLP, reports an LC50 value of >21 mg/L air (mist) (Scientific Associates Inc. 1977). The key acute dermal toxicity study, conducted according to a guideline similar to OECD Test Guideline 402 but prior to GLP compliance, reports a LD50 value of 1500-2000 mg/kg bw in rabbit, which is a combined value for intact and abraded skin (Scientific Associates Inc. 1977). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e54d1ca9-741f-48fd-826c-e4b69f34303f/documents/b799a972-f6d3-415d-82bc-b85012b28f3f_8bdf963b-d49d-457a-a055-22098926bb1b.html,,,,,, Hexan-1-ol,111-27-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e54d1ca9-741f-48fd-826c-e4b69f34303f/documents/b799a972-f6d3-415d-82bc-b85012b28f3f_8bdf963b-d49d-457a-a055-22098926bb1b.html,,oral,LD50,"3,210 mg/kg bw",adverse effect observed, Hexan-1-ol,111-27-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e54d1ca9-741f-48fd-826c-e4b69f34303f/documents/b799a972-f6d3-415d-82bc-b85012b28f3f_8bdf963b-d49d-457a-a055-22098926bb1b.html,,dermal,LD50,"1,500 mg/kg bw",adverse effect observed, Hexan-1-ol,111-27-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e54d1ca9-741f-48fd-826c-e4b69f34303f/documents/b799a972-f6d3-415d-82bc-b85012b28f3f_8bdf963b-d49d-457a-a055-22098926bb1b.html,,inhalation,LC50,21 mg/m3,adverse effect observed, Hexyl benzoate,6789-88-4, Acute oral toxicity: LD50: 12300 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6504891d-4031-47f8-84b4-99a35a4487cc/documents/abb290f1-cc19-4e94-a9f6-3da3c2fd08c4_08f8a12b-4440-4265-b7f6-23eb0fb1aae5.html,,,,,, Hexyl hexanoate,6378-65-0," Acute oral toxicity is based upon read-across from similar substances in a weight of evidence approach. The read-across data has been taken from existing publications which have been assessed according to the Klimisch et al, 1997 scale to be suitably relevant and reliable for REACH registration. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97686272-1522-4b55-86b7-cce29bc9e3c1/documents/f2f146d2-1d27-4b76-b1d6-51004f8d2f62_af7cbcd6-7bda-4c93-9662-aa27b92d575d.html,,,,,, Hexyl hexanoate,6378-65-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97686272-1522-4b55-86b7-cce29bc9e3c1/documents/f2f146d2-1d27-4b76-b1d6-51004f8d2f62_af7cbcd6-7bda-4c93-9662-aa27b92d575d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Hexyl laurate,34316-64-8,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a5feae8c-7c15-4497-9afa-4dceeab30585/documents/IUC5-e58d5622-6106-4329-a063-3bbfd65a1591_6755eab9-3708-47ca-9620-9625b8934a4c.html,,,,,, Hexyl laurate,34316-64-8,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5feae8c-7c15-4497-9afa-4dceeab30585/documents/IUC5-bf51705a-199d-460a-ad99-4758ce610c7b_6755eab9-3708-47ca-9620-9625b8934a4c.html,,,,,, Hexyl methacrylate,142-09-6," For n-hexyl methacrylate one acute toxicty study (oral) is availible (International Bio-Research, 1978). In this valid acute oral toxicity study (According to the ""Appraisal of the safety of chemicals in foods, drugs and cosmetics"", by the Staff of the Division of Pharmacology, FDA, 1959) groups of ten male and ten female SPF-Wistar rats (weight: 150 to 230 g) were given a single oral dose of 20 ml/kg n-hexylmethacrylate. Animals were then observed for 14 days. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67c76921-0066-4625-a552-6bef6d263dcf/documents/fa4c0244-75cf-44a7-8ecb-7b17707155a8_88637c4f-2798-4d21-89a5-c68b51427b0d.html,,,,,, Hexyl methacrylate,142-09-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67c76921-0066-4625-a552-6bef6d263dcf/documents/fa4c0244-75cf-44a7-8ecb-7b17707155a8_88637c4f-2798-4d21-89a5-c68b51427b0d.html,,oral,LD50,"17,720 mg/kg bw",no adverse effect observed, Octan-2-one,111-13-7, Repeated dose oral: The no observed adverse effect level (NOAEL) for test substance when administered orally by intubation to male rats was 10 mg/kg/day daily in 16 days study period. The study does not conclude higher dose value. Hence it is acceptable to take such low NOAEL . Repeated dose inhalation: The No Observed Adverse effect concentration (NOAEC) was considered to be  in a dose range of 80 ppm (80 mg/L) (actual dose 78.6 mg/L or 78600 mg/m3) - 6.6mg/m3 when rodents were  treated with test substance. Repeated dose dermal: The No observed adverse effect level (NOAEL) is 400 mg/kg in chronic dermal toxicity study when rats were exposed to  test substance for 21 weeks. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4aa007e9-44d2-400b-8e49-abe9a9d9f547/documents/IUC5-3f5ef376-2b0f-41fa-8960-a628a39b6c9e_d5d23f12-b29c-4bbe-bc5f-2d6c5fbe8212.html,,,,,, Octan-2-one,111-13-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4aa007e9-44d2-400b-8e49-abe9a9d9f547/documents/IUC5-3f5ef376-2b0f-41fa-8960-a628a39b6c9e_d5d23f12-b29c-4bbe-bc5f-2d6c5fbe8212.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Octan-2-one,111-13-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4aa007e9-44d2-400b-8e49-abe9a9d9f547/documents/IUC5-3f5ef376-2b0f-41fa-8960-a628a39b6c9e_d5d23f12-b29c-4bbe-bc5f-2d6c5fbe8212.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,,rat Octan-2-one,111-13-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4aa007e9-44d2-400b-8e49-abe9a9d9f547/documents/IUC5-3f5ef376-2b0f-41fa-8960-a628a39b6c9e_d5d23f12-b29c-4bbe-bc5f-2d6c5fbe8212.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"78,600 mg/m3",,rat Octan-2-one,111-13-7," Acute oral toxicity:  Acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the given test chemical. The LD50 value was considered in between 300-2000 mg/kg bw. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity. Acute Inhalation toxicity:  Acute Inhalation toxicity dose (LC50) was considered based on different studies conducted on mice and rats for the test chemical. The LC50 value was considered to be >1300 mg/L (i.e. >1300000 mg/m3). The study concluded that the LC50 value is >5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute Inhalation toxicity. Acute Dermal toxicity:  The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aa007e9-44d2-400b-8e49-abe9a9d9f547/documents/IUC5-ecc32358-e2c3-44d1-8e67-c5ff451f2680_d5d23f12-b29c-4bbe-bc5f-2d6c5fbe8212.html,,,,,, Octan-2-one,111-13-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aa007e9-44d2-400b-8e49-abe9a9d9f547/documents/IUC5-ecc32358-e2c3-44d1-8e67-c5ff451f2680_d5d23f12-b29c-4bbe-bc5f-2d6c5fbe8212.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, Octan-2-one,111-13-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aa007e9-44d2-400b-8e49-abe9a9d9f547/documents/IUC5-ecc32358-e2c3-44d1-8e67-c5ff451f2680_d5d23f12-b29c-4bbe-bc5f-2d6c5fbe8212.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Octan-2-one,111-13-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aa007e9-44d2-400b-8e49-abe9a9d9f547/documents/IUC5-ecc32358-e2c3-44d1-8e67-c5ff451f2680_d5d23f12-b29c-4bbe-bc5f-2d6c5fbe8212.html,,inhalation,LC50,"1,300,000 mg/m3",no adverse effect observed, Hexyl propionate,2445-76-3,"A subchronic toxicity study performed on a suitable structural analogue, Octyl Acetate, was used in a read-across approach to extrapolate the results to the target substance, Hexyl Propionate. Rats were exposed to Octyl Acetate via oral gavage during 13 weeks at 100, 500 or 1000 mg/kg bw/d. Several treatment-related effects were observed in the 1000 mg/kg bw/d group: slight reductions in body weight and food consumption, increased liver and kidney weights, mild tubular nephropathy in males. The specific findings consisted of an increased incidence of dilated renal tubules (cortical-medullary zone) containing granular casts and regenerative hyperplasia in proximal convoluted tubules. The NOAEL of Octyl Acetate was set at 500 mg/kg bw/d. Taking into account the molecular weight of Hexyl Propionate, the NOAEL of Hexyl Propionate for systemic toxicity was predicted to be 459 mg/kg bw/d (see OECD QSAR Toolbox analysis). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study is available in the REACH dossier of Octyl Acetate and has also been published in 1989 by Daughtrey et al. The publication was released in the Fundamental and Applied Toxicology journal, which has a good impact factor. The article was peer reviewed and is fully referenced. No information on the GLP status is available. The study is considered to be reliable with restrictions (Klimisch score of 2) and is acceptable for the read-across. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79db4287-93e8-488f-af93-6534a71345a0/documents/f597e637-d512-4e00-9227-3e0b365c23d5_aa884dd2-87be-4bc9-875e-7881d1211989.html,,,,,, Hexyl propionate,2445-76-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79db4287-93e8-488f-af93-6534a71345a0/documents/f597e637-d512-4e00-9227-3e0b365c23d5_aa884dd2-87be-4bc9-875e-7881d1211989.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,459 mg/kg bw/day,,rat Hexyl propionate,2445-76-3," Acute Oral Toxicity Oral LD50 > 5'000 mg/kg bw (eq. to OECD 401, K, Rel.2) Acute Inhalation Toxicity Waived (see justification in the related endpoint) Acute Dermal Toxicity Dermal LD50 > 5'000 mg/kg bw (eq. to OECD 402, K, Rel.2) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79db4287-93e8-488f-af93-6534a71345a0/documents/b61ff58c-6035-44a1-b66f-e2d7c1b1ee8e_aa884dd2-87be-4bc9-875e-7881d1211989.html,,,,,, Hexyl propionate,2445-76-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79db4287-93e8-488f-af93-6534a71345a0/documents/b61ff58c-6035-44a1-b66f-e2d7c1b1ee8e_aa884dd2-87be-4bc9-875e-7881d1211989.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Hexyl propionate,2445-76-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79db4287-93e8-488f-af93-6534a71345a0/documents/b61ff58c-6035-44a1-b66f-e2d7c1b1ee8e_aa884dd2-87be-4bc9-875e-7881d1211989.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Hexyl salicylate,6259-76-3," Repeated dose toxicity, oral: No oral repeated dose toxicity data are available for hexyl salicylate; however read-across data are available for the category substances methyl salicylate (17-week rat study, 2-year rat study, 8-week dog study, 2-year dog study) and isoamyl salicylate (90-day rat study). The data are relatively old but together provide a consistent weight of evidence. Repeated dose toxicity, inhalation: NOAEC inhalation (28d, rat, f/m) ≥ 249 mg/m3 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5347f2e7-e1ea-468b-ae1b-e269b181f91b/documents/IUC5-52de1a54-ea5d-40b6-9718-2ce2b67d6cba_49244b1f-dc10-445a-ae91-63a6c816a87d.html,,,,,, Hexyl salicylate,6259-76-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5347f2e7-e1ea-468b-ae1b-e269b181f91b/documents/IUC5-52de1a54-ea5d-40b6-9718-2ce2b67d6cba_49244b1f-dc10-445a-ae91-63a6c816a87d.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,249 mg/m3,,rat Hexyl salicylate,6259-76-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5347f2e7-e1ea-468b-ae1b-e269b181f91b/documents/IUC5-52de1a54-ea5d-40b6-9718-2ce2b67d6cba_49244b1f-dc10-445a-ae91-63a6c816a87d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Hexyl salicylate,6259-76-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5347f2e7-e1ea-468b-ae1b-e269b181f91b/documents/IUC5-52de1a54-ea5d-40b6-9718-2ce2b67d6cba_49244b1f-dc10-445a-ae91-63a6c816a87d.html,Repeated dose toxicity – local effects,inhalation,NOAEC,249 mg/m3,no adverse effect observed,rat Hexyl salicylate,6259-76-3," A rat acute oral toxicity study and a rabbit acute dermal toxicity study are available. The older, proprietary studies were also published in a review of available toxicological data relating to several salicylates used as fragrance ingredients. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5347f2e7-e1ea-468b-ae1b-e269b181f91b/documents/IUC5-b2f8d042-16e9-4527-8bfc-383a95cda336_49244b1f-dc10-445a-ae91-63a6c816a87d.html,,,,,, Hexyl salicylate,6259-76-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5347f2e7-e1ea-468b-ae1b-e269b181f91b/documents/IUC5-b2f8d042-16e9-4527-8bfc-383a95cda336_49244b1f-dc10-445a-ae91-63a6c816a87d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Hexyl salicylate,6259-76-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5347f2e7-e1ea-468b-ae1b-e269b181f91b/documents/IUC5-b2f8d042-16e9-4527-8bfc-383a95cda336_49244b1f-dc10-445a-ae91-63a6c816a87d.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-hexylcyclopentan-1-one,13074-65-2,"In reliable limit tests, the acute oral and dermal toxicity of hexyl cyclopentanone was determined to be greater than 5000 mg/kg bw in rats and rabbits, respectively (Moreno, 1980). No acute inhalation studies are available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a8c527e-85ac-4978-8bfc-a5279ac65773/documents/IUC5-85f40c54-b515-42be-939f-f2be55b5b37e_70c0b23f-1468-4e06-8dc9-02ece8aedbd8.html,,,,,, 2-hexylcyclopentan-1-one,13074-65-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a8c527e-85ac-4978-8bfc-a5279ac65773/documents/IUC5-85f40c54-b515-42be-939f-f2be55b5b37e_70c0b23f-1468-4e06-8dc9-02ece8aedbd8.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-hexylcyclopentan-1-one,13074-65-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a8c527e-85ac-4978-8bfc-a5279ac65773/documents/IUC5-85f40c54-b515-42be-939f-f2be55b5b37e_70c0b23f-1468-4e06-8dc9-02ece8aedbd8.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-hexyldecanoic acid,25354-97-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch 2 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33a5d4e8-44d1-4591-b9d8-9d2338e7d1f6/documents/a38231c6-11a9-429a-bc81-f21f35d233aa_6eafed08-2be2-4800-bbe5-14d0efb3e4af.html,,,,,, 2-hexyldecanoic acid,25354-97-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33a5d4e8-44d1-4591-b9d8-9d2338e7d1f6/documents/a38231c6-11a9-429a-bc81-f21f35d233aa_6eafed08-2be2-4800-bbe5-14d0efb3e4af.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-hexyldecanoic acid,25354-97-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33a5d4e8-44d1-4591-b9d8-9d2338e7d1f6/documents/61759c2a-91d2-45cb-b2ee-caa91f8d8a7c_6eafed08-2be2-4800-bbe5-14d0efb3e4af.html,,oral,discriminating dose,"2,020 mg/kg bw",no adverse effect observed, 2-hexyldecan-1-ol,2425-77-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f8cdc5f-0caa-4110-857d-307164f59644/documents/IUC5-e112f2a2-4809-4589-92f2-da82fec508fc_2e866481-2769-4351-91ac-07d0fa50de86.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,839.6 mg/kg bw/day,,rat 2-hexyldecan-1-ol,2425-77-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f8cdc5f-0caa-4110-857d-307164f59644/documents/IUC5-6b028ee0-5a05-4412-abbf-298047397036_2e866481-2769-4351-91ac-07d0fa50de86.html,,oral,discriminating dose,"33,476 mg/kg bw",no adverse effect observed, 2-hexyldecan-1-ol,2425-77-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f8cdc5f-0caa-4110-857d-307164f59644/documents/IUC5-6b028ee0-5a05-4412-abbf-298047397036_2e866481-2769-4351-91ac-07d0fa50de86.html,,dermal,discriminating dose,"1,674 mg/kg bw",no adverse effect observed, "2-methylpentane-2,4-diol",107-41-5,"  A -14 day range finding by oral route was performed (Fabreguettes, 1999): The daily administration of the test substance, HEXYLENE GLYCOL, at the dose-levels of 0, 40, 200, or 1000 mg/kg/day, by gavage to rats for 2-weeks induced no adverse effects at any dose-level. The notable findings were the increased demand in liver function in both sexes at 1000 mg/kg/day and presence of acidophilic globules in the cortical epithelium of the kidneys in males at 200 and 1000 mg/kg/day (minimal to severe). A 90-day, GLP, repeated dose oral toxicity study in rats conducted according to OECD test guideline 408 (Fabreguette, 1999) followed by a 4 week treatment free period demonstrated a NOEL for hexylene glycol of 50 mg/kg body weight/day and a NOAEL of 450 mg/kg body weight/day (the highest dose tested). Supportive data from a GLP 14-day dose range finding study in rats (NOAEL 1000 mg/kg body weight/day; the highest dose tested) indicate a low order of toxicity for hexylene glycol when administered by the oral route. Dermal and inhalation studies have not been conducted.Two additional 2 weeks repeated dose studies were performed in rat and rabbit to select dose-levels for the developmental studies in both species (OECD 414).A number of older studies have been reported but are not considered reliable indicators of the systemic effects of HG following repeated administration, because of limited exposure duration, limited toxicity assessments, and/or deficient experimental design. The effects they do report are consistent with those observed in the key study.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP study ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31d8a3cc-e0c8-4c0d-89a3-d85876ff883e/documents/IUC5-e892bd7d-0073-4549-9db1-073a6484d999_e020c49e-4e4b-4765-bbd9-719eef15f0ca.html,,,,,, "2-methylpentane-2,4-diol",107-41-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31d8a3cc-e0c8-4c0d-89a3-d85876ff883e/documents/IUC5-e892bd7d-0073-4549-9db1-073a6484d999_e020c49e-4e4b-4765-bbd9-719eef15f0ca.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat "2-methylpentane-2,4-diol",107-41-5,"HG is of low acute toxicity following oral and dermal exposures. Reported oral LD0 values for HG were greater than 2000 mg/kg body weight in rats for both routes of administration. Detailed information on the acute inhalation toxicity of HG is not available. However, the results reported in a reliable investigation have indicated that exposure of male rats to a vapour of HG did not result in deaths within a 8-hour exposure time.Acute Toxicity: OralAcute oral toxicity studies on hexylene glycol (HG), one of which was performed according to test guidelines, have demonstrated that the compound is of low acute toxicity following oral exposure to rats. The studies conducted (described below) all report on LD0 values of greater than 2000 mg/kg body weight for HG.An acute oral toxicity study on HG has been performed in accordance with OECD Guidelines for the Testing of Chemicals No. 420 and in compliance with GLP (, 1996). A sighting study was undertaken to allow selection of the discriminating dose level for the main study. The preliminary investigation was conducted in 2 fasted female rats dosed at 500 mg/kg body weight. Neither of the 2 fasted rats died. Clinical signs included pilo-erection in one rat 3 to 4 hours after dosing. Macroscopic examination at necropsy on day 15 revealed slight distension and darkening of the uterus of one rat. Since no mortality was observed in the sighting study, 5 male and 5 female fasted Crl: CD BR rats were orally administered 2000 mg/kg body weight of HG in water (vehicle) by gavage in a volume of 10 mL/kg body weight in the main study. Animals were observed over a 15-day period. No deaths occurred. Clinical signs were apparent in all rats from 2 to 3 hours after dosing and included ataxia, decreased activity, muscular flaccidity, and palpebral closure. Pilo-erection and dark feces also were observed 4 hours after dosing. Animals recovered by day 2. In addition, all rats achieved body weight gains during the first and second weeks of the study. Macroscopic examination at necropsy on day 15 revealed renal pelvic dilatation in one female and a red and distended cecum in another female. Based on the results and under the conditions of the study, the oral LD0 was greater than 2000 mg/kg body weight.The results of a study conducted by Smyth et al. (1948) support the low acute oral toxicity of HG reported by(1996). In their investigation, Smyth et al. (1948) determined the LD50 of HG in male Sherman rats to be 4700 mg/kg body weight as assessed following oral gavage administration of a range of HG doses (reported as 10, 1, 0.1, etc. g/kg body weight).Acute Toxicity: DermalAcute dermal toxicity studies on HG, one of which was performed according to test guidelines, have demonstrated that the compound is of low acute toxicity following dermal exposure to rats. The dermal LD0 of HG is greater than 2000 mg/kg body weight in rats, and also has been determined to be 13.3 mL/kg body weight in this species. In addition, no clinical signs of systemic toxicity or skin irritation or other dermal reactions were observed in rats.An acute dermal toxicity study on HG has been performed in accordance with OECD Guidelines for the Testing of Chemicals No. 402 and in compliance with GLP (, 1996). The study was performed in Crl: CD BR rats in which 5 male and 5 female animals were dermally administered 2000 mg/kg body weight of HG in a volume of 2.22 mL/kg body weight. The test substance was applied to the dorsal area (10% of total body surface) under semi-occlusive conditions for an exposure period of 24 hours. Animals were observed over a 15-day period. There were no irritation reactions or other dermal changes at the sites of HG application. In addition, no deaths occurred and no clinical signs of systemic toxicity were observed. A small loss in weight loss was observed in one female on day 15, but no other effects on body weight were observed. Gross pathology revealed renal pelvic dilatation in 2 rats and an enlarged spleen in one other animal. The dermal LD0 of HG was determined to be greater than 2000 mg/kg body weight in rats.The results of a study conducted by Smythet al. (1948) support the low acute dermal toxicity of HG reported by(1996). In their investigation, Smyth et al. (1948) determined the dermal LD50 of HG in male rabbits to be 13.3 mL/kg body weight as assessed following dermal administration with the use of a rubber cuff.Acute Toxicity: InhalationAcute inhalation toxicity studies that follow current test guidelines have not been performed, and therefore, are not available. However, the results reported by Smyth et al. (1948) are deemed reliable.One acute inhalation toxicity study has been conducted among the series of acute toxicity tests conducted by Smythet al. (1948). In their investigation, male rats were exposed for a maximum of 8 hours to a flowing stream of air substantially saturated with a vapour of HG, concentrations of which fell into a geometric series with a constant ratio of two. No deaths occurred within the 8-hour exposure time. No other information was available.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): GLP study ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31d8a3cc-e0c8-4c0d-89a3-d85876ff883e/documents/IUC5-76999b15-da98-43f2-8c6e-31d913f07b38_e020c49e-4e4b-4765-bbd9-719eef15f0ca.html,,,,,, "2-methylpentane-2,4-diol",107-41-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31d8a3cc-e0c8-4c0d-89a3-d85876ff883e/documents/IUC5-76999b15-da98-43f2-8c6e-31d913f07b38_e020c49e-4e4b-4765-bbd9-719eef15f0ca.html,,oral,LD0,"2,000 mg/kg bw",no adverse effect observed, "2-methylpentane-2,4-diol",107-41-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31d8a3cc-e0c8-4c0d-89a3-d85876ff883e/documents/IUC5-76999b15-da98-43f2-8c6e-31d913f07b38_e020c49e-4e4b-4765-bbd9-719eef15f0ca.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, "3-(hexyloxy)propane-1,2-diol",10305-38-1,"Oral (OECD TG 423), rat: LD50 cut-off value: 2500 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c41e936-bb93-493f-a8d0-2c7802b68784/documents/IUC5-bbe8eae1-48c3-4b28-a4fc-a12a54a81399_38b8c4df-93d5-4ab0-951f-49117f4a4859.html,,,,,, "Furan, 5-(hexyloxy)tetrahydro-2,2-dimethyl-",1497420-94-6,Acute oral toxicity: OECD TG 423: > 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4cce4a70-7194-4363-b850-f13c805f951a/documents/IUC5-b47babbf-0adf-4d0f-9253-b9f86269192a_3e392187-278c-4a4b-bd70-e71bb5f1b3c7.html,,,,,, "Furan, 5-(hexyloxy)tetrahydro-2,2-dimethyl-",1497420-94-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4cce4a70-7194-4363-b850-f13c805f951a/documents/IUC5-b47babbf-0adf-4d0f-9253-b9f86269192a_3e392187-278c-4a4b-bd70-e71bb5f1b3c7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-hexyloxyethanol,112-25-4,"No repeated dose toxicity studies for the oral route are available. For the dermal, a GLP study in rabbits, similar to OECD guideline is available. However, the study duration was only 11 days, during which 9 dermal applications were given. For the inhalation route, a 14-week study in rats is available, conducted under GLP and according to OECD guideline 413. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/369ffbe7-cc2b-4de8-b04c-f62c96fdf7c2/documents/3d40e360-cf49-4ade-91c8-a9a5dc2e39c6_56523d90-054e-45e5-a79d-375e1a1bf8d8.html,,,,,, 2-hexyloxyethanol,112-25-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/369ffbe7-cc2b-4de8-b04c-f62c96fdf7c2/documents/3d40e360-cf49-4ade-91c8-a9a5dc2e39c6_56523d90-054e-45e5-a79d-375e1a1bf8d8.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,222 mg/kg bw/day,,rabbit 2-hexyloxyethanol,112-25-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/369ffbe7-cc2b-4de8-b04c-f62c96fdf7c2/documents/3d40e360-cf49-4ade-91c8-a9a5dc2e39c6_56523d90-054e-45e5-a79d-375e1a1bf8d8.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,245 mg/m3,,rat 2-hexyloxyethanol,112-25-4,"Non-GLP studies equivalent to OECD guidelines 401, 402 and 403 are available in rats and rabbits. In addition, a GLP study equivalent to OECD guideline 403 is available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/369ffbe7-cc2b-4de8-b04c-f62c96fdf7c2/documents/dd8f3d53-81b5-4abd-9bd6-15cc95b3b04f_56523d90-054e-45e5-a79d-375e1a1bf8d8.html,,,,,, 2-hexyloxyethanol,112-25-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/369ffbe7-cc2b-4de8-b04c-f62c96fdf7c2/documents/dd8f3d53-81b5-4abd-9bd6-15cc95b3b04f_56523d90-054e-45e5-a79d-375e1a1bf8d8.html,,oral,LD50,738 mg/kg bw,adverse effect observed, 2-hexyloxyethanol,112-25-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/369ffbe7-cc2b-4de8-b04c-f62c96fdf7c2/documents/dd8f3d53-81b5-4abd-9bd6-15cc95b3b04f_56523d90-054e-45e5-a79d-375e1a1bf8d8.html,,dermal,LD50,757 mg/kg bw,adverse effect observed, Hexyltrimethoxysilane,3069-19-0, Oral:  OECD TG 401: LD50 > 3500 mg/kg bw (read across from CAS 1067 -25 -0 and 3069 -40 -7) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a680a4f6-632d-453d-be22-f310419a9639/documents/d564ab5b-a304-4c57-a899-3a58197cc1bd_a4da0771-aa13-4d56-ab08-ff7324fcbcd1.html,,,,,, Hexyltrimethoxysilane,3069-19-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a680a4f6-632d-453d-be22-f310419a9639/documents/d564ab5b-a304-4c57-a899-3a58197cc1bd_a4da0771-aa13-4d56-ab08-ff7324fcbcd1.html,,oral,discriminating dose,"3,500 mg/kg bw",no adverse effect observed, 12-oxahexadecan-16-olide,6707-60-4," The experimental rat LD50 dosed via the oral route was >5000 mg/kg (Klimisch 4). The experimental rat LD50 dosed via the oral route was >2000 and <8000 mg/kg (Klimisch 4). Therefore, even though the experimental data are on Klimisch 4, the consistant volue confirms the low oral toxicity of Cervolide and the lack of classification. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64b20a23-c584-4170-9b67-41c0c3a7fece/documents/991904e6-ea00-469c-ab1a-1abf1cba7010_c347be4d-f2ef-45f3-b60c-8ea07d9e1ed0.html,,,,,, 12-oxahexadecan-16-olide,6707-60-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64b20a23-c584-4170-9b67-41c0c3a7fece/documents/991904e6-ea00-469c-ab1a-1abf1cba7010_c347be4d-f2ef-45f3-b60c-8ea07d9e1ed0.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Okra, ext.",91723-07-8, acute oral toxicity: no effects expected ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8134d4f7-d979-40ed-a6aa-9171820014f2/documents/9c894202-268a-4d88-b7f2-674c90e20b22_1a11ccc6-5ea1-4ba2-89c4-43a26e57f0c0.html,,,,,, "Okra, ext.",91723-07-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8134d4f7-d979-40ed-a6aa-9171820014f2/documents/9c894202-268a-4d88-b7f2-674c90e20b22_1a11ccc6-5ea1-4ba2-89c4-43a26e57f0c0.html,,oral,LD50,"2,000 mg/kg bw",, Histidine,71-00-1,L-histidine does not require to be classified according to the criteria of the CLP regulation. The most stringent concentrations found for L-histidine are 472.9 mg/kg bw/day for males and 558.45 mg/kg bw/day for females. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/846ffde7-b188-455e-814e-5d68de23f2bd/documents/2df25b08-14c8-4110-90d8-5187728540ab_db6d9702-2cee-4cb9-8bd0-1889a0566843.html,,,,,, Histidine,71-00-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/846ffde7-b188-455e-814e-5d68de23f2bd/documents/2df25b08-14c8-4110-90d8-5187728540ab_db6d9702-2cee-4cb9-8bd0-1889a0566843.html,Chronic toxicity – systemic effects,oral,NOAEL,472.9 mg/kg bw/day,,rat Histidine,71-00-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Remark: No mortalities occurred in any of the experiments. The LD50 is therefore > 5110 mg/kg bw. However, this result cannot be entered in the preceding field. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/846ffde7-b188-455e-814e-5d68de23f2bd/documents/dba61e4a-ad59-4823-9121-335fd8249486_db6d9702-2cee-4cb9-8bd0-1889a0566843.html,,,,,, Histidine,71-00-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/846ffde7-b188-455e-814e-5d68de23f2bd/documents/dba61e4a-ad59-4823-9121-335fd8249486_db6d9702-2cee-4cb9-8bd0-1889a0566843.html,,oral,LD50,"5,110 mg/kg bw",no adverse effect observed, L-histidine monohydrochloride,645-35-2,"Oral: In a key chronic oral feeding study in rats comparable to OECD guideline 451 (reference 7.5.1-1), animals in the 2.5% groups of both sexes showed slightly shorter mean survival although these were not statistically significant. The growth curves indicated that the 2.5% group had a significant depression of body weight gain. Statistically significant increases in red blood cell count, haemoglobin value, haematocrit and platelet count were observed in male rats fed with 2.5% HMHC, while no significant changes were found in females. Non-neoplastic changes were observed frequently in all groups, including control groups, without any significant differences between the groups. No statistically significant increase in the incidence of any tumour was found in the treated groups of either sex. Even though no NOAEL (carcinogenic effects) was derived in this study, based on the significant depression of body weight gain in the 2.5% test group, in both males and females, the NOAEL (systemic effects) of 472.9 mg/kg bw/day for males and 558.45 mg/kg bw/day for females could be derived (1.25% test groups). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/265ba88a-f74c-4f1e-86fe-18c9b8006a93/documents/c98701f0-e43d-4ab7-85cc-5f4264ac0f34_49feca74-e1f9-435a-9324-a92e92887885.html,,,,,, L-histidine monohydrochloride,645-35-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/265ba88a-f74c-4f1e-86fe-18c9b8006a93/documents/c98701f0-e43d-4ab7-85cc-5f4264ac0f34_49feca74-e1f9-435a-9324-a92e92887885.html,Chronic toxicity – systemic effects,oral,NOAEL,472.9 mg/kg bw/day,,rat L-histidine monohydrochloride,645-35-2,"Oral: In an in vivo study the acute toxicity of the read-across substance (L-Histidine, CAS 71-00-1) was assessed in rats via gavage in a similar way as described in the OECD Guideline 423. The LD50 value after oral administration of the test substance was found to be > 5110 mg/kg bw in male and female rats. (UN GHS: No Category) (reference 7.2.1-1). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/265ba88a-f74c-4f1e-86fe-18c9b8006a93/documents/61aed3c2-303f-47c6-a284-73e48a2af702_49feca74-e1f9-435a-9324-a92e92887885.html,,,,,, L-histidine monohydrochloride,645-35-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/265ba88a-f74c-4f1e-86fe-18c9b8006a93/documents/61aed3c2-303f-47c6-a284-73e48a2af702_49feca74-e1f9-435a-9324-a92e92887885.html,,oral,discriminating dose,"5,110 mg/kg bw",no adverse effect observed, L-Histidine Hydrochloride Monohydrate,5934-29-2," In an acute oral toxicity study in rats conducted according to OECD 423, the target substance L-Histidine Hydrochloride Monohydrate (HHM) showed no mortality at the limit dose of 2000 mg/kg bw. Hence, the LD50 value was considered to exceed 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/064fce03-7fc8-4f8c-b0cb-fae18d4ee86a/documents/fa23d848-ae9e-4cc4-bf4c-ef3cc1948c65_5397098f-34d8-4502-b213-8fa680707070.html,,,,,, "3,7-dimethylnona-2,6-dienenitrile",61792-11-8," No-observed-adverse effect level (NOAEL) was considered to be 2000 ppm (equivalent to 111 mg/kg bw/d and 128 mg/kg bw/d for males and females, respectively). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6028155f-554d-4780-8402-d18a4e1386d7/documents/IUC5-c721c659-7363-4120-ae41-60a8a874f696_1169c543-f78b-4a53-8995-1347657907bc.html,,,,,, "3,7-dimethylnona-2,6-dienenitrile",61792-11-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6028155f-554d-4780-8402-d18a4e1386d7/documents/IUC5-c721c659-7363-4120-ae41-60a8a874f696_1169c543-f78b-4a53-8995-1347657907bc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,111 mg/kg bw/day,,rat "3,7-dimethylnona-2,6-dienenitrile",61792-11-8,Acute toxicity (oral): LD50>2000mgkg.Acute toxicity (inhalation): No data; negligible exposure from useAcute toxicity (dermal): LD50>2000mg/kg. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6028155f-554d-4780-8402-d18a4e1386d7/documents/IUC5-b6d66742-1762-4913-a84b-93c5d0469a3f_1169c543-f78b-4a53-8995-1347657907bc.html,,,,,, "3,7-dimethylnona-2,6-dienenitrile",61792-11-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6028155f-554d-4780-8402-d18a4e1386d7/documents/IUC5-b6d66742-1762-4913-a84b-93c5d0469a3f_1169c543-f78b-4a53-8995-1347657907bc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,7-dimethylnona-2,6-dienenitrile",61792-11-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6028155f-554d-4780-8402-d18a4e1386d7/documents/IUC5-b6d66742-1762-4913-a84b-93c5d0469a3f_1169c543-f78b-4a53-8995-1347657907bc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,5-dimethyl-1-vinylhept-4-enyl acetate",61931-80-4, Repeated dose toxicity - oral (OECD 422): NOAEL >= 1000 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/710e0aaa-2b54-450b-9d45-d54a74c2cf42/documents/dd3fcbf4-c309-4bcd-8cdb-529feed81963_62d5c06f-606b-41de-b8de-3c5aa7bda056.html,,,,,, "1,5-dimethyl-1-vinylhept-4-enyl acetate",61931-80-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/710e0aaa-2b54-450b-9d45-d54a74c2cf42/documents/dd3fcbf4-c309-4bcd-8cdb-529feed81963_62d5c06f-606b-41de-b8de-3c5aa7bda056.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,5-dimethyl-1-vinylhept-4-enyl acetate",61931-80-4, Acute oral toxicity in rat (pre-guideline study): LD50 = 2790 mg/kg bw (read-across) Acute inhalation toxicity in mice (non-guideline study): LC50 > 3.2 mg/L (read-across) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/710e0aaa-2b54-450b-9d45-d54a74c2cf42/documents/bf55a03f-2525-43bc-819e-b1e32e629316_62d5c06f-606b-41de-b8de-3c5aa7bda056.html,,,,,, "1,5-dimethyl-1-vinylhept-4-enyl acetate",61931-80-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/710e0aaa-2b54-450b-9d45-d54a74c2cf42/documents/bf55a03f-2525-43bc-819e-b1e32e629316_62d5c06f-606b-41de-b8de-3c5aa7bda056.html,,oral,LD50,"2,790 mg/kg bw",no adverse effect observed, "1,5-dimethyl-1-vinylhept-4-enyl acetate",61931-80-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/710e0aaa-2b54-450b-9d45-d54a74c2cf42/documents/bf55a03f-2525-43bc-819e-b1e32e629316_62d5c06f-606b-41de-b8de-3c5aa7bda056.html,,inhalation,LC50,"3,200 mg/m3",no adverse effect observed, "6,6-dimethylbicyclo[3.1.1]hept-2-ene-2-propionaldehyde",33885-51-7,"Under the conditions of the test (OECD 422, GLP), the systemic NOAEL was determined to be at least 120 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e8c8f9f-1ed3-43e6-8003-822aaf030d95/documents/96b0786b-e2dd-4ee3-a486-66746c2da18e_842d421b-493e-49a9-8f9d-3360ef437f5b.html,,,,,, "6,6-dimethylbicyclo[3.1.1]hept-2-ene-2-propionaldehyde",33885-51-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e8c8f9f-1ed3-43e6-8003-822aaf030d95/documents/96b0786b-e2dd-4ee3-a486-66746c2da18e_842d421b-493e-49a9-8f9d-3360ef437f5b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat "6,6-dimethylbicyclo[3.1.1]hept-2-ene-2-propionaldehyde",33885-51-7, Acute oral toxicity: LD50 between 200 and 2000 mg/kg bw with a derived geometric mean value of 632 mg/kg bw in an OECD TG 423. Acute inhalation toxicity: LC50 is 1651 mg/m3 which is derived from the acute oral LD50 using route to route extrapolation. Acute dermal toxicity: LD50 is 632 mg/kg bw which is derived from the acute oral LD50 using route to route extrapolation. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e8c8f9f-1ed3-43e6-8003-822aaf030d95/documents/IUC5-96c6ab21-8383-4f55-9c33-ed8799727d5c_842d421b-493e-49a9-8f9d-3360ef437f5b.html,,,,,, "6,6-dimethylbicyclo[3.1.1]hept-2-ene-2-propionaldehyde",33885-51-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e8c8f9f-1ed3-43e6-8003-822aaf030d95/documents/IUC5-96c6ab21-8383-4f55-9c33-ed8799727d5c_842d421b-493e-49a9-8f9d-3360ef437f5b.html,,oral,LD50,632 mg/kg bw,adverse effect observed, "6,6-dimethylbicyclo[3.1.1]hept-2-ene-2-propionaldehyde",33885-51-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e8c8f9f-1ed3-43e6-8003-822aaf030d95/documents/IUC5-96c6ab21-8383-4f55-9c33-ed8799727d5c_842d421b-493e-49a9-8f9d-3360ef437f5b.html,,dermal,LD50,632 mg/kg bw,adverse effect observed, "6,6-dimethylbicyclo[3.1.1]hept-2-ene-2-propionaldehyde",33885-51-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e8c8f9f-1ed3-43e6-8003-822aaf030d95/documents/IUC5-96c6ab21-8383-4f55-9c33-ed8799727d5c_842d421b-493e-49a9-8f9d-3360ef437f5b.html,,inhalation,LC50,"1,651 mg/m3",adverse effect observed, Homosalate,118-56-9,"For the repeat dose endpoint, an OECD 422 study was available for homosalate (Dettwiler, 2013), the target substance. Read across studies were also available including a 90-day oral toxicity study (OECD 408) conducted on 2-ethylhexyl salicylate (IRDC, 1994), and chronic toxicity studies conducted on methyl salicylate (Webb and Hansen, 1963; Gage, 1970) and chronic toxicity studies conducted on menthol (NCI, 1979; Tracor Jitco, 1976). From these studies the range of NOAELs for the repeat-dose toxicity endpoint are as follows: NOAEL subacute oral study with homosalate (28-day toxicity section of OECD 422): 300 mg/kg/day NOAEL subchronic (OECD 408) oral study with 2-ethylhexyl salicylate: 250 mg/kg/day NOAEL (for homosalate) from chronic oral studies in rats and dogs and a subchronic study in rats with read-across substance methyl salicylate: 86 mg/kg/day for homosalate adjusted from 50 mg/kg/day for methyl salicylate. A higher NOAEL of 250 mg/kg/day was obtained in a subchronic dog study. NOAEC (for homosalate) from subacute inhalation study (OECD 412) with read-across substance methyl salicylate: 1207 mg/m³ for homosalate adjusted from 700 mg/m³ for methyl salicylate NOAEL (for menthol as surrogate for second metabolite) from chronic toxicity study in rats (OECD 453) 250 mg/kg/day. The following studies were available for this endpoint: Endpoint Study Substance NOAEL Repeat dose toxicity: oral   Dettwiler M. 2013. Neo Heliopan HMS: Combined repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test in the Han Wistar Rat. Key study. Homosalate 300 mg/kg/day Webb and Hansen. 1963. Chronic and subacute toxicology and pathology of methyl salicylate in dogs, rats, and rabbits. 2-year study conducted in rats. Key study. Methyl salicylate 50 mg/kg/day Webb and Hansen. 1963. Chronic and subacute toxicology and pathology of methyl salicylate in dogs, rats, and rabbits. 2-year study conducted in dogs. Key study. Methyl salicylate 50 mg/kg/day IRDC. 1994. Octyl Salicylate: 13-Week Oral (Dietary) Sub-chronic Toxicity Study in Rats. Key study. 2-ethylhexyl salicylate 250 mg/kg/day Webb and Hansen. 1963. Chronic and subacute toxicology and pathology of methyl salicylate in dogs, rats, and rabbits. 17-week study in rats. Supporting study. Methyl salicylate 50 mg/kg/day Webb and Hansen. 1963. Chronic and subacute toxicology and pathology of methyl salicylate in dogs, rats, and rabbits. 59-day study in dogs. Supporting study. Methyl salicylate 250 mg/kg/day National Cancer Institute. 1979. Bioassay for dl-menthol for possible carcinogenicity – rat study. Supporting study. Menthol 375 mg/kg/day National Cancer Institute. 1979. Bioassay for dl-menthol for possible carcinogenicity – mouse study. Supporting study. Menthol 667 mg/kg/day Tracor Jitco. 1976. 90-day range-finding study in F344 rats. Supporting study. Menthol 1000 mg/kg/day Tracor Jitco. 1976. 90-day range-finding study in B6C3F1 mice. Supporting study. Menthol 1071 mg/kg/day Repeat dose toxicity: inhalation Gage JC. 1970. Subacute inhalation toxicity of 109 industrial chemicals. Br J Ind Med.; 27:1-18. Methyl salicylate 700 mg/m3 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bce15553-9643-4870-99b9-313528412347/documents/IUC5-ec618cfe-5ebc-46ef-8885-05afa22cb824_1782fb6e-f054-40ec-aa64-26bdcd005a7f.html,,,,,, Homosalate,118-56-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bce15553-9643-4870-99b9-313528412347/documents/IUC5-ec618cfe-5ebc-46ef-8885-05afa22cb824_1782fb6e-f054-40ec-aa64-26bdcd005a7f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Homosalate,118-56-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bce15553-9643-4870-99b9-313528412347/documents/IUC5-ec618cfe-5ebc-46ef-8885-05afa22cb824_1782fb6e-f054-40ec-aa64-26bdcd005a7f.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,207 mg/m3",,rat Homosalate,118-56-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bce15553-9643-4870-99b9-313528412347/documents/IUC5-ec618cfe-5ebc-46ef-8885-05afa22cb824_1782fb6e-f054-40ec-aa64-26bdcd005a7f.html,Chronic toxicity – systemic effects,oral,NOAEL,86 mg/kg bw/day,, Homosalate,118-56-9,"LD50 (oral, rat): >5000 mg/kgLD50 (dermal, rabbit): >5000 mg/kg ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bce15553-9643-4870-99b9-313528412347/documents/IUC5-57cfead8-daa3-4085-a6c8-291f59b9d9c3_1782fb6e-f054-40ec-aa64-26bdcd005a7f.html,,,,,, Peroxidase,9003-99-0,"Acute toxicity via the oral route has been tested. No signs of toxicity were observed in rats treated with a single oral dose of 2.1 mg enzyme concentrate dry matter/kg bw. The test was conducted according to OECD guidelines and GLP standards. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Substantial documentation on the safety of the production strain has been generated, and the enzyme test material was thoroughly characterized. The study was conducted in accordance with OECD test guidline No. 401, 1987 and in compliance with GLP. The database can thus be considered of high quality. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8ddcde2-9d82-41e9-86e9-2e6bbe36b065/documents/2ea57ff4-217b-4f2a-be69-59a2345b20a5_04963d67-37e8-4f25-ade8-c700fbb6fa06.html,,,,,, "Hop, Humulus lupulus, ext.",8060-28-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/243b4550-2b85-4b05-9c41-112fad31e2cd/documents/03ff0751-034f-4a98-997e-04d5bb6e20d9_5361720d-7596-4e5c-bdfc-5bf1528af269.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Hop, Humulus lupulus, ext.",8060-28-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/243b4550-2b85-4b05-9c41-112fad31e2cd/documents/5d1a8f64-5d4a-4875-b2e2-11763d296641_5361720d-7596-4e5c-bdfc-5bf1528af269.html,,oral,LD50,"2,000 mg/kg bw",, "Hop, Humulus lupulus, ext.",8060-28-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/243b4550-2b85-4b05-9c41-112fad31e2cd/documents/5d1a8f64-5d4a-4875-b2e2-11763d296641_5361720d-7596-4e5c-bdfc-5bf1528af269.html,,dermal,LD50,"2,000 mg/kg bw",, Silicon dioxide,7631-86-9,"Oral The database for the assessment of repeated dose oral toxicity comprises 3 subacute, 4 subchronic and 4 chronic studies performed from 1958 to 2020 conducted with different forms of SAS, nanostructured. The different production types of SAS, nanostructured are all represented. The studies meet the criteria of Klimisch score 1 or 2. Most studies were conducted as feeding studies but also gavage studies are available. Significant substance related specific toxicity was absent in all studies and an overall NOAEL > 1000 mg/kg bw/day can be derived. Effects observed at higher concentrations above the limit dose were attributed to malnutrition due to the high silica intake. Of note, concerns related to potential systemic toxicity of SAS, nanostructured were raised based on the finding of vacuolization of tubular epithelial cells in kidneys of mice (Boudard et al., 2019). An in-depth review of the publication however revealed that the effects reported as adverse in mice after ingestion of food-grade precipitated silica at a single low-dose level (NM-200 in drinking water, 4.5 mg/kg bw/day for up to 18 months) were within the range of normal and expected background alterations in wild-type mice of this strain and age (Weber, 2020). Furthermore, adverse kidney findings were not reported in GLP and guideline studies performed with precipitated silica (NM-200), including the limit dose (1000 mg/kg bw/day) recommended by the OECD guidelines for such type of studies (Lewin, 2011). Given the very limited documentation, the use of only one single dose level and hence the impossibility to infer a dose-response relationship, and the dosing with levels that are within the naturally occurring silica content of drinking water, the findings reported by Boudard et al. in 2019 are not suitable to substantiate a potential kidney toxicity. This was confirmed in a more recent study which was conducted to determine the chronic toxicity study of SAS, nanostructured (SIPERNAT 22S) according to OECD Guideline 452, in compliance with GLP. The test substance was administered daily in graduated doses of 0, 100, 300, and 1000 mg/kg bw/day for 12 months in rats. Animals of an additional control group were handled identically as the dose groups but received sterile water. The 4 groups comprised of 20 male and 20 female Wistar rats. To detect possible delayed occurrence or persistence of or recovery from toxic effects, recovery groups (control and high dose) were observed for 28 d following the last administration. These groups each comprised an additional 5 male and 5 female Wistar rats. Test item formulations were prepared weekly, divided into daily aliquots. Formulations were administered daily during a 12-month treatment period to male and female animals. Dose formulation analyses were performed to investigate the stability, homogeneity and total silicon concentration in test substance formulations. Additionally, particle size distribution, pH, conductivity and solid content were investigated. During the period of administration, animals were observed each day for signs of toxicity. Detailed clinical observations were performed monthly, and ophthalmological examinations were at the end of the treatment and recovery period. Body weight and food consumption were measured weekly. Blood and urine were collected for further analyses after 3 and 6 months and at the end of the treatment and recovery period. At the end of the treatment (study Day 372) and recovery period (study Day 400), respective animals were sacrificed and subjected to necropsy. The wet weight of a subset of tissues was taken, and a set of selected organs/tissues was preserved. Animals that died during the study were examined macroscopically, and at the end of the treatment or recovery period, surviving animals were sacrificed and observed macroscopically. A full histopathological evaluation of selected tissues was performed on high dose and control animals as well as for decedents. No histopathological evaluation was performed for low, mid dose and recovery animals. Any organs showing treatment-related changes in the high dose group were also examined for the other dose groups and in the recovery group. Any gross lesion macroscopically identified was examined microscopically in all animals. No toxicologically relevant clinical signs or findings during ophthalmological analyses were observed during the treatment and recovery period of the study. No toxicologically relevant effects on body weight, food consumption, parameters of haematology or clinical biochemistry could be observed during the treatment and recovery period of the study. No toxicologically relevant effects detectable on urine were identified, neither after a treatment period of approx. 3 and 6 months, nor at the end of the treatment or recovery period. No toxicologically relevant effects on organ weights and blood coagulation were seen at the end of the treatment or recovery period of the study. No test item-related macroscropic findings were observed during necropsy. Findings were either considered as incidential or as a consequence of misgavage. There were no treatment-related gross lesions or histological findings in any of the organs and tissues examined. There were no findings that distinguished control group from test item-treated animals. No pathological change was recorded in the intestinal segments, and specifically, no unusual findings were noted in the Peyer’s patches. There were also no specific findings, e.g. fibrosis, in the liver or kidneys. Furthermore, there were no specific lesions in immune organs (spleen, thymus, lymph nodes, GALT, BALT, bone marrow) that could be attributed to treatment with the test item. Overall, all dose levels of the test material were well tolerated. Mortality only occurred as a consequence of the highly viscous test item formulations and the resulting difficulties in application. No toxicologically relevant clinical signs or findings during ophthalmological analyses were observed during the treatment and recovery period of the study. No toxicologically relevant effects on body weight, food consumption, urine, parameters of haematology or clinical biochemistry could be observed during the treatment and recovery period of the study. No toxicologically relevant effects on organ weights and blood coagulation were seen at the end of the treatment or recovery period of the study. No test item-related macroscropic findings were observed during necropsy. There were no treatment-related gross lesions or histological findings in any of the organs and tissues examined. No pathological change was recorded in the intestinal segments, and specifically, no unusual findings were noted in the Peyer’s patches. There were also no specific findings, e.g. fibrosis, in the liver or kidneys. Furthermore, there were no specific lesions in immune organs (spleen, thymus, lymph nodes, GALT, BALT, bone marrow) that could be attributed to treatment with the test item. Under the study conditions, the NOEL was established at 1000 mg/kg bw/day for both sexes (Ehrenberg, 2021). Inhalation The database for the assessment of repeated dose inhalation toxicity comprises 2 subacute, 4 subchronic and 1 chronic studies performed from 1968 to 2019 with different forms of SAS, nanostructured. The studies meet the criteria of Klimisch score 1 or 2. Overall, the effects depicted through these studies showed a similar pattern but differences in severity of the pathological effects were observed. This is explained by inconsistent study design such as exposure conditions, rat strain and test substance variations (e.g., particle size, primary structure, surface area, number, density, and solubility). It has also to be noted that, in the more recent studies, the assays were conducted with a fraction of SAS significantly different from commercial silica grades. The aerosol generation requires a respirable fraction that can only be achieved by applying very high shearing forces like in the case of milling. Consequently, in the resulting test atmosphere, more than 99% of the particle fraction is below 10 µm, enabling the particles to reach the deep lung. By comparison, only minor amounts (less than 1%) of the commercially available SAS are present in the form of respirable particles under normal handling and use conditions. A 13-week repeated dose inhalation study followed by a 52-week recovery period was conducted with different SAS, nanostructured (AEROSIL 200, SIPERNAT 22 S) according to OECD Guideline 413, in compliance with GLP. Wistar rats (70/sex/group) were exposed at concentrations of 0, 1, 6 and 30 mg/m3 (AEROSIL 200 - nominal) and 30 mg/m3 (SIPERNAT 22 S - nominal) for 13 weeks, 6 h/day, 5 days/week. After the exposure period, animals of each group were retained for an observation period up to 52 weeks. The concentrations of the different test materials in the test atmosphere were determined by gravimetry. Animals were visually inspected daily for clinical symptoms and behaviour. Bodyweight changes were observed at start of exposure and weekly for 13 weeks. In a post observation (recovery) period of up to 52 weeks, bodyweight changes were monitored every 4 weeks. Haematological examinations and urine analysis were performed in Weeks 13, 26, 40, 52, and 65. Clinical chemistry examinations and gross pathology were performed in Weeks 14, 27, 40/41, 53, and 66. Histopathological examination was conducted on all organs for animals of the high dose group and all controls and on the nose, larynx, trachea, hilus, mediastinal lymph nodes and lungs of low- and mid-dose groups. SiO2 content and hydroxyproline content in lungs were also assessed. No treatment-related mortality or clinical signs were observed in any of the groups. A decrease in body weight of males of the mid- and high-dose groups was observed, whereas the males of the low-dose group were only affected during the first half of exposure. Haematological observations included increased red blood cell counts in males of the high-dose group, increased white blood cell counts in males and females of the mid- and high-dose groups and increased number of neutrophilic leucocytes in females of the low-dose group, but these effects disappeared after ca. 13-39 weeks of recovery. Males of the high-dose group exhibited lower blood glucose values at the end of exposure. Urine analysis were essentially negative. There was an increase of absolute and relative lung weights in mid- and high-dose groups animals. Recovery of lung weights occurred in all groups (rather slowly in rats exposed to AEROSIL 200 and quickly in rats exposed to SIPERNAT 22S). Thymus weights were increased in male rats exposed to SIPERNAT 22S at the end of the exposure period. Collagen content in lung was increased in all groups at the end of the exposure period but recovered slowly during the observation period. Silica could be detected in lungs of all test groups at the end of exposure period. The regional lymph nodes of rats exposed to AEROSIL 200 exhibited no or only slight amounts of silica while larger amounts were detected in the rats exposed to SIPERNAT 22S. During the observation period, no silica could be detected in lungs and regional lymph nodes of exposed to AEROSIL 200. In rats exposed to SIPERNAT 22S silica was gradually and completely cleared from the lungs, but in the lymph nodes silica was found during the total observation period. In all test animals, gross examination at autopsy reveals swollen and spotted lungs, having a spongy consistency and/or irregular surface, and enlarged mediastinal lymph nodes. Histopathological changes were found in the lungs, mediastinal lymph nodes and nose. In lungs, it was characterized by accumulation of alveolar macrophages, granular material, cellular debris and polymorphonuclear leucocytes, increase septal cellularity, alveolar bronchiolization, interstitial fibrosis and cholesterol clefts. In the mediastinal lymph nodes, accumulation of macrophages with or without necrosis was observed while in the nose, focal necrosis and slight atrophy of the nasal olfactory epithelium was seen only at the end of the exposure period. Overall, these changes in lung and mediastinal lymph node were most severe at the end of the exposure period after which they recovered partly or fully during the observation period. Under the study conditions, the NOAEC of the test substance in rats exposed by inhalation for 13 weeks was determined to be >1.3 - <5.9 mg/m³ (Reuzel, 1987). The fibrosis findings from this study were later reviewed by a pathology working group using the same (original) tissue slides according to the highest current standards. In this assessment the results of the study were re-evaluated according to diagnostic criteria and updated terminology in line with the latest recognized texts and scientific literature, that is, according to International Nomenclature and Harmonization of Diagnostic Criteria (INHAND) nomenclatures dated from 2009. The Working Group concluded that the rapid clearance of the tested synthetic amorphous silica would not lead to persistent inflammation and epithelial cell proliferation, and therefore would not result in fibrosis/lung tumour induction (Weber, 2018). These findings were confirmed in a study requested by the European Chemicals Agency (ECHA) in which a high- (CAB-O-SIL S17D) and a low- (AEROSIL OX 50) specific surface area (SSA) SAS, nanostructured grade was tested. The toxicity of the two test materials was investigated in a repeated dose 90-day nose-only inhalation study conducted according to OECD Guideline 413, in compliance with GLP. Wistar rats (males and females) were exposed at concentrations of 0, 0.5, 1, 2.5 and 5 mg/m3 for 13 weeks, 6 h/day, 5 days/week. After the exposure period, animals of each group were retained for an observation period up to 12 months. Using a feeding system and pressurized air dispersion nozzle (dynamic system) system, a mass median aerodynamic diameter (MMAD) of ≤ 3 µm could be achieved. At the end of exposure dose-dependent particle related local inflammation in lung and lung associated tissues (lymph nodes) was observed accompanied by corresponding changes of inflammatory markers in the bronchoalveolar fluid. Any clinical effects or morphological changes of other tissues indicating systemic toxicity were not associated with SAS exposure. Test item related changes in lungs were dose-dependent and characterized by increased perivascular infiltration, alveolar macrophages and macrophage aggregations as well as macrophage type II hyperplasia. Accordingly, reactive changes were observed in the bronchus-associated lymphoid tissues (BALT) and regional lymph nodes. These effects were not substance-specific as all respirable particles will show the similar response directly after exposure (day 1). Based on the varying biosolubility of these two SAS nanoforms, reversibility of effects was demonstrated for both SAS grades examined. This study with high- and low- surface area pyrogenic SAS showed no lung fibrosis and accordingly no increase of collagen. With regard to lung clearance, SAS accumulates in the regional lymph nodes associated with increase of lymph node size and inflammatory changes at the end of exposure. CAB-O-SIL S 17D exposed animals showed reversibility of lymph node effects in all affected dose groups at the end of recovery. Most likely based on the lower solubility, AEROSIL OX 50 exposed animals showed still morphological inflammatory changes after 1 year recovery in all dose groups. These lymph node findings were not accompanied by any other findings up to a dose of 2.5 mg/m³ at the end of recovery. The lower lung and lymph node effect concentration of AEROSIL OX 50 compared to CAB-O-SIL S 17D is most likely related to the lower biosolubility of this SAS grade resulting in an extension of the lung clearance. The results of the lymph nodes are indicating that solubility of AEROSIL OX 50 requires a longer period of time compared to CAB-O-SIL S 17D. Under the conditions of the studies, based on histopathology and inflammatory markers, the most conservative NOAEC for the lung in rats exposed to SAS for 13 weeks via inhalation was established at 1 mg/m3 (Creutzenberg, 2019). Overall, the effects observed in inhalation animal studies with SAS, nanostructured were restricted to the respiratory tract with no systemic effects noted. The observations made during the recovery period indicate that these effects were transient. Dermal The database for the assessment of repeated dose dermal toxicity comprises one study performed in 1958 with a SAS, nanostructured (SSA 175-225 m2/g) meeting the criteria for Klimisch score 2 and showing low chronic toxicity. The test substance, CAB-O-SIL M5, was evaluated for its repeated dose dermal toxicity in rabbits for 21 days. Albino rabbits (2/sex/dose, 1.5 - 1.9 kg at test start) were exposed at 0, 5000 and 10000 mg/kg bw/day. There was one negative control (0.5% w/v aqueous methylcellulose at 2.0 ml/kg bw/day) and one positive control (#1625 cosmetic talc at 10 g/kg bw/day). Prior to study initiation, the fur was removed from the abdominal skin area with electric clippers. Thereafter, the skin was removed twice weekly. The control and test substances were applied to the intact abdominal skin area of one male and one female of each group. The skin of the two remaining animals from each group was abraded initially and at the beginning of the second and third weeks of the study by means of a hypodermic needle which was used to make a series of longitudinal and transverse scratches over the exposed skin area. The scratches penetrated the outer epidermis but did not induce bleeding. The 0.5% w/v aqueous methylcellulose was applied under a non-absorbent paper backing to the skin of the control animals. The #1625 cosmetic talc and the test substance were moistened with sufficient 0.5% w/v aqueous methylcellulose to form a paste. The paste was spread evenly on a non-absorbent paper backing and applied to the closely clipped abdominal skin, then covered with a gauze and adhesive tape binder. Each daily exposure period lasted about 18 hours. At the end of the exposure period, the binders were removed, and the exposed skin was wiped with a dry cloth to remove excess material. Daily before reapplication of the substances, the animals were weighed and observed for gross signs of dermal irritation and systemic toxicity. Applications were made daily on a five day per week basis, for a total of 15 applications. The remaining two days, animals were observed but no material was applied to the skin. On the day of the 14th application, urine was collected form surviving animals. Two days after the 15th application, the rabbits were sacrificed. A blood sample was collected, and gross autopsies were performed. Samples of liver, kidney, spleen, blood, and urine from each animal were preserved by freezing for silicon dioxide content analysis. Histopathological examination was conducted on the skin of each animal, as well as on lung, liver, kidney, small intestine, and spleen (1/2 of the animals only due to restricted sample size) of positive control, negative control and high dose animals. There was no mortality or treatment-related effect on bodyweight noted during the study. In general, the animals in each control and test groups exhibited mild erythema and mild to moderate atonia consistently throughout the study. From the beginning of the second week until sacrifice, the exposed skin of each animal showed mild or moderate desquamation. In the control and test rabbits with abraded skin areas, there appeared to be complete healing of the skin during the week following the periodic abrasions. The skin immediately surrounding the abrasions showed a slightly greater degree of erythema than the remaining exposed skin. Otherwise, the degree of irritation was comparable among the intact and abraded skin of each group. There was no evidence of systemic effects or of gross or microscopic pathology related to treatment with the test substance. The silicon dioxide content of blood, urine, spleen, liver, and kidney was comparable for control and test animals. The authors did not derive a NOAEL for the study. However, based on the results, the NOAEL of the test substance in male and female rabbits following repeated dermal exposure for 3 weeks can be considered >= 10000 mg/kg bw/day (Elsea, 1958). Considering the findings of the dermal penetration/percutaneous absorption study conducted according to OECD Guideline 428, showing clear evidence of no dermal penetration of SAS, nanostructured (Johnson, 2013; Johnson, 2021a; Johnson, 2021b) and the low chronic toxicity observed in rabbits (Elsea, 1958), no systemic toxicity is expected after dermal exposure. References Weber K. 2020. Letter regarding ""Chronic oral exposure to synthetic amorphous silica (NM-200) results in renal and liver lesions in mice"". Kidney Int. Rep. 5(4):550-554.  ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f45e0594-0618-4fda-bfd0-8108096d5ea1/documents/fab4bf90-ee41-4055-875e-a95aeabce4c6_c9ab84d6-58ac-4ac8-a828-eaf539751f78.html,,,,,, Silicon dioxide,7631-86-9,"Oral Twenty acute oral toxicity studies were conducted with non surface treated SAS (including Tixosil 53, Sident 9, Sipernat 225, Zeo 49, Zeosyl 200, Zeosyl 113, Syloid 378, Zeofree 153, CAB-O-SIL M5 and F2, Syloid 244, Aerosil 200, CAB-O-SIL EH5, and TS-100) according to OECD Guideline 401, 420, 423, or similar in either rats or mice. Mortality and significant toxicity were absent in all the studies. LD50 values exceeded the top doses tested. Overall, LD50 values >2000 mg/kg bw or >5000 mg/kg bw were established (Guillot, 1986; Zechel, 1990; Leuschner, 1977a-c; Woltjen, 1978a-d; Rutter, 1971; Spanjers, 1979; Vasudevan, 1999; Hazelton, 1958, 1964a and b; Gardner, 1988; Hackenberg, 1974; Baskaran, 1977; Wingard, 1981; Lilja, 1990). Inhalation For the acute inhalation toxicity assessment of non surface treated SAS, six studies are available, only one of which is considered reliable. A study was conducted with Zeosil Premium 200 MP according to OECD Guideline 436. Rats were exposed by nose-only, flow-past inhalation at a mean concentration of 5.01 mg/L air for 4 h as a limit test. Under the study conditions, the LC50 was considered to be > 5.01 mg/L air (de la Torre, 2019). All other studies have technical deficiencies and do not entirely fulfill the criteria laid down in OECD Guideline 403. The achievable test concentrations varied over 3 orders of magnitude and, due to the limited particle size information and the expected agglomeration of the tested SAS forms after atmosphere generation in the test chamber, the real exposure conditions of the animals could not be verified. Dermal Five acute dermal toxicity studies are available for non surface treated SAS. A study was conducted with Syloid 244 according to the guidelines of the US Department of Transportation.  The test substance was applied to the abraded or non abraded skin of rabbits for 24 h, and the animals were then observed for 48 h. There were no signs of skin irritation and the LD50 was >2000 mg/kg bw (Guber, 1978). In another series of tests, rabbits were exposed to the test substance (Zeo 49, Zeosyl 113, Zeosyl 200, Zeofree 153, or Syloid 244) on intact and abraded skin as a single application at 4 dose levels. Exposure lasted 24 h and was followed by a 14 d observation period. In all cases, the LD50 was >5000 mg/kg bw (Woltjen, 1978a-d). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f45e0594-0618-4fda-bfd0-8108096d5ea1/documents/e3ccbc3f-d41f-4033-9d60-37da2c14b335_c9ab84d6-58ac-4ac8-a828-eaf539751f78.html,,,,,, Silicon dioxide,7631-86-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f45e0594-0618-4fda-bfd0-8108096d5ea1/documents/e3ccbc3f-d41f-4033-9d60-37da2c14b335_c9ab84d6-58ac-4ac8-a828-eaf539751f78.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Silicon dioxide,7631-86-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f45e0594-0618-4fda-bfd0-8108096d5ea1/documents/e3ccbc3f-d41f-4033-9d60-37da2c14b335_c9ab84d6-58ac-4ac8-a828-eaf539751f78.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Silicon dioxide,7631-86-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f45e0594-0618-4fda-bfd0-8108096d5ea1/documents/e3ccbc3f-d41f-4033-9d60-37da2c14b335_c9ab84d6-58ac-4ac8-a828-eaf539751f78.html,,inhalation,LC50,> 5 mg/L,adverse effect observed, 2-phenylpropan-1-ol,1123-85-9," A subchronic oral toxicity study, dosed via feed at concentrations of 10, 40 and 160 mg/kg bw/day, has revealed few effects that can be definitely attributed to treatment. The liver- and kidney-weight increases are considered to be treatment-related, although it is uncertain whether these were toxic or adaptive effects. Hence, clear adverse effects were not identified in this study and the authors, on this basis, have set the no-effect level (NOEL) for this study to 10 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e72c1c40-8a55-46c7-a50b-a2be651433a8/documents/d5323d65-db45-45ab-aefc-8b23bd258acb_d2ff0b59-518b-4b42-b71e-afa3dca74778.html,,,,,, 2-phenylpropan-1-ol,1123-85-9," The substance 2-phenylpropan-1-ol was tested for acute oral toxicity to rats and an LD50 of 2.3 g/kg bw was found. When tested for acute dermal toxicity to rabbits, and LD50 of >5 g/kg bw was found. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e72c1c40-8a55-46c7-a50b-a2be651433a8/documents/d266b992-5358-4488-a4f9-d1d0fe4994c2_d2ff0b59-518b-4b42-b71e-afa3dca74778.html,,,,,, 2-phenylpropan-1-ol,1123-85-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e72c1c40-8a55-46c7-a50b-a2be651433a8/documents/d266b992-5358-4488-a4f9-d1d0fe4994c2_d2ff0b59-518b-4b42-b71e-afa3dca74778.html,,oral,LD50,"2,300 mg/kg bw",adverse effect observed, 2-phenylpropionaldehyde-dimethyl acetal,90-87-9, Acute oral toxicity: similar to OECD TG 401: LD50 1850 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ca3b0c0-5a46-4f00-8993-6b7f480002ca/documents/5654f121-f6ee-48bd-b6f6-1efc33406eff_61cb1103-1cc9-426f-8956-46641595e8f3.html,,,,,, 2-phenylpropionaldehyde-dimethyl acetal,90-87-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ca3b0c0-5a46-4f00-8993-6b7f480002ca/documents/5654f121-f6ee-48bd-b6f6-1efc33406eff_61cb1103-1cc9-426f-8956-46641595e8f3.html,,oral,LD50,"1,850 mg/kg bw",adverse effect observed, Hydrogen bromide,10035-10-6,"Though there are minimal animal repeated dose data on hydrogen bromide (HBr) available (supporting study provided in Section 8.6.1: 20-day repeated inhalation study in the rat), there are sufficient data available on the analogue substance hydrogen chloride (HCl) (Section 8.6.2; inhalation exposure) to indicate an appropriate level for hazard identification for the main route of exposure (i.e., inhalation). The available data on the analogue HCl have been used for indication of an EU Indicative Occupational Exposure Level value (IOELV) for HBr given in Directive 2000/39/EC (15 minute IOELV limit = 6.7 mg/m3 or 2 ppm). Additional routes of exposure (i.e., oral or dermal) are not considered as appropriate routes for determination of repeated dose toxicity. Inhalation exposure to phosphorus tribromide may also be used as an indication of HBr toxicity. PBr3 reacts with moisture in the air and on wet surfaces to produce phosphonic acid and hydrogen bromide gas (HBr). The hydrolysis rate for this reaction is 4 x 10-17 cm2/s. At a relative humidity of 5%, hydrolysis half-life is 810 milliseconds. This decreases to 81 milliseconds at 50% RH, and 41 milliseconds for 100% RH. HBr is a substance that rapidly undergoes changes in contact with moisture – either in the air or in contact with respiratory or oral tissues. (See Annex VIII Section 9.2.2.1 Hydrolysis). HBr is generally unmeasurable in the body as it changes directly to hydrobromic acid in water forming hydrogen and bromide ions. In air, it may form bromine, but the reaction pathway ultimately ends with the formation of bromide ions (Annex VIII Section 8.8.1 Toxicokinetics assessment). It is generally accepted that bromide is the chemical moiety of concern for long-term assessment of systemic HBr toxicity. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37cdedb9-f9c5-46aa-a425-fd85d46d3d96/documents/IUC5-285c9716-12d9-4e98-a0b6-dcc69624b18d_037d5cc5-cd4d-465c-b8f7-117f8a77dfcc.html,,,,,, Hydrogen bromide,10035-10-6,"Hydrogen bromide (HBr) is an inorganic gas under standard temperature and pressures and forms a strong mineral acid (hydrobromic acid) in water. HBr and hydrobromic acid are classified/labelled with the symbols ""C"" and ""Xi"" and the risk phrases ""R35"" and ""R37"". Though there are minimal animal repeated dose data on hydrogen bromide (HBr) available there are sufficient data available on the analogue substances hydrogen chloride (HCl) and phosphorus tribromide which hydrolyses to phosphonic acid and HBr. (Read-across justifications in Section 8.6 Repeat dose toxicity)In an oral administration test, the LD50 value for hydrogen chloride has been determined to be 238-277 mg/kg bw for female rats (OECD SIDS 2002)Stavert, D.M., et al. (1991) indicated the toxic effects of hydrogen bromide were comparable to those of hydrogen chloride and hydrogen fluoride on the respiratory system at a high concentration of exposure (1300 ppm). There is a reported inhalation LC50 valueof 2860 ppm (9464.55 mg/m3) in rats (Back, K.C., et al., 1972). In a 4-hour nose only exposure to the analogue substance PBr3, female rats gave an LC100 at ca. 4 mg/L. The report summarised in Wolfe, R.E., et al. (1997) also noted that corrosion and local irritation effects were observed in the low dose of 1.48 mg/L. Stavert, D.M., et al. (1991) indicated that the effects of hydrogen bromide were comparable to hydrogen chloride and hydrogen floride and the threshold concentrations for hydrogen bromide vapours are about three times higher than bromine ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37cdedb9-f9c5-46aa-a425-fd85d46d3d96/documents/IUC5-b839b0cc-4abd-4326-8a97-e2e1f1e983de_037d5cc5-cd4d-465c-b8f7-117f8a77dfcc.html,,,,,, Hydrogen bromide,10035-10-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37cdedb9-f9c5-46aa-a425-fd85d46d3d96/documents/IUC5-b839b0cc-4abd-4326-8a97-e2e1f1e983de_037d5cc5-cd4d-465c-b8f7-117f8a77dfcc.html,,oral,LD50,238 mg/kg bw,, Hydrogen bromide,10035-10-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37cdedb9-f9c5-46aa-a425-fd85d46d3d96/documents/IUC5-b839b0cc-4abd-4326-8a97-e2e1f1e983de_037d5cc5-cd4d-465c-b8f7-117f8a77dfcc.html,,inhalation,LC50,"9,464.55 mg/m3",, "1-chloro-1,1-difluoroethane",75-68-3,The NOAEL for repeated dose toxicity is higher than 41000 mg/m3 in rats exposed for a period of 3 months and higher than 82000 mg/m3 in rats exposed for a period of 2 years. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5491ba14-7042-41f1-8695-41b54b41b795/documents/IUC5-00a02da3-9648-49c9-a264-3e91d437232b_9985bc24-3281-407d-bf6e-5dfd70c8a3c0.html,,,,,, "1-chloro-1,1-difluoroethane",75-68-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5491ba14-7042-41f1-8695-41b54b41b795/documents/IUC5-00a02da3-9648-49c9-a264-3e91d437232b_9985bc24-3281-407d-bf6e-5dfd70c8a3c0.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"82,000 mg/m3",, "1-chloro-1,1-difluoroethane",75-68-3,"The acute inhalation toxicity of 1-chloro-1,1-difluoroethane is low. The recalulated 4h LC50 in rats is established to be >1877331 mg/m3. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5491ba14-7042-41f1-8695-41b54b41b795/documents/IUC5-d8e4ea5d-f586-4216-9f0c-941c4a06d7dc_9985bc24-3281-407d-bf6e-5dfd70c8a3c0.html,,,,,, Chlorodifluoromethane,75-45-6,"According to Annex XI No. 2 the testing is technically not possible (not feasible): testing for a specific endpoint may be omitted if it is technically not possible to conduct the study as a consequence of the properties of the substance, e.g. high volatibility. The method described by Annex B.1 - Acute oral toxicity - is not applicable. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7fc9652-af1c-4823-948b-bab0e1fe368e/documents/IUC5-97bbdfa6-451f-413a-a244-faa1921883e5_92dee439-0583-4825-aca7-609415a1d18a.html,,,,,, 3-phenylpropyl acetate,122-72-5, 3-Phenylpropyl acetate is not likely to be toxic upon repeated exposure by oral route. ,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/94e7561c-8fe3-4eef-8773-7e30c81e157b/documents/IUC5-aee38fed-dd52-4421-a773-1f40b9373c96_f48476e5-ed34-41a3-a1cb-52e491a24c25.html,,,,,, 3-phenylpropyl acetate,122-72-5,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/94e7561c-8fe3-4eef-8773-7e30c81e157b/documents/IUC5-aee38fed-dd52-4421-a773-1f40b9373c96_f48476e5-ed34-41a3-a1cb-52e491a24c25.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,699.5 mg/kg bw/day,,rat 3-phenylpropyl acetate,122-72-5,3- Phenylpropyl acetate is likely to be non hazardous by oral and dermal route of exposure in rats and rabbits. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94e7561c-8fe3-4eef-8773-7e30c81e157b/documents/IUC5-5d91b4dd-96be-4fcb-bff8-d6513c28622c_f48476e5-ed34-41a3-a1cb-52e491a24c25.html,,,,,, 3-phenylpropyl acetate,122-72-5,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94e7561c-8fe3-4eef-8773-7e30c81e157b/documents/IUC5-5d91b4dd-96be-4fcb-bff8-d6513c28622c_f48476e5-ed34-41a3-a1cb-52e491a24c25.html,,oral,LD50,"4,700 mg/kg bw",no adverse effect observed, 3-phenylpropyl acetate,122-72-5,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94e7561c-8fe3-4eef-8773-7e30c81e157b/documents/IUC5-5d91b4dd-96be-4fcb-bff8-d6513c28622c_f48476e5-ed34-41a3-a1cb-52e491a24c25.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Norflurane,811-97-2,"A low order of toxicity was demonstrated for 1,1,1,2-tetrafluoroethane (HFC 134a) in repeated inhalation studies with no adverse effects observed at exposure concentrations of up to 50000ppm (208000mg/m3). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d343ee36-93a8-4b5c-9a68-382b9413946e/documents/b9783342-27c5-4e71-a1c5-92212b074967_af2e0457-dd3d-4a48-8236-6cf273294e8b.html,,,,,, Norflurane,811-97-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d343ee36-93a8-4b5c-9a68-382b9413946e/documents/b9783342-27c5-4e71-a1c5-92212b074967_af2e0457-dd3d-4a48-8236-6cf273294e8b.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"208,000 mg/m3",, Norflurane,811-97-2,"Inahaltion studies have shown 1,1,1,2-Tetrafluoroethane (HFC 134a) to be of an extremely low order of acute toxicity, with the 4 hour LC50 in the rat judged to be in excess of 500000ppm (2080000 mg/m3). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d343ee36-93a8-4b5c-9a68-382b9413946e/documents/aafbcfa1-c84b-48aa-8001-6d9d8c3f5a63_af2e0457-dd3d-4a48-8236-6cf273294e8b.html,,,,,, Norflurane,811-97-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d343ee36-93a8-4b5c-9a68-382b9413946e/documents/aafbcfa1-c84b-48aa-8001-6d9d8c3f5a63_af2e0457-dd3d-4a48-8236-6cf273294e8b.html,,inhalation,LC50,"2,080,000 mg/m3",, "1,1-difluoroethane",75-37-6,"Chronic Inhalation: Equivalent to OECD453, rat, NOAEC = 67485 mg/m3. Reliability = 1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f107069-856e-40a5-b7f0-fd35076b12d5/documents/81187f0d-e825-482d-aef0-1b036ded911b_e782459c-5d30-479d-82b4-d8b34821154f.html,,,,,, "1,1-difluoroethane",75-37-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f107069-856e-40a5-b7f0-fd35076b12d5/documents/81187f0d-e825-482d-aef0-1b036ded911b_e782459c-5d30-479d-82b4-d8b34821154f.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"67,485 mg/m3",,rat "1,1-difluoroethane",75-37-6,Inhalation: Acute Lethal Concentration (ALC) Test; rat; NOAEC = 66400 ppm (179280 mg/m3). Reliability = 2 ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f107069-856e-40a5-b7f0-fd35076b12d5/documents/80ed7ede-bbce-4129-9ef4-2feab75899ff_e782459c-5d30-479d-82b4-d8b34821154f.html,,,,,, "1,1-difluoroethane",75-37-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f107069-856e-40a5-b7f0-fd35076b12d5/documents/80ed7ede-bbce-4129-9ef4-2feab75899ff_e782459c-5d30-479d-82b4-d8b34821154f.html,,inhalation,discriminating conc.,"179,280 mg/m3",adverse effect observed, "1,1,1,2,3,3,3-heptafluoropropane",431-89-0,The NOAEL for repeated dose toxicity is higher than 731690 mg/m3 (105000 ppm) in rats exposed for a period of 90 days. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2c49e7e-2af1-4c76-8c83-5faf68380b4d/documents/IUC5-fd4db634-bcfc-47c7-a5a2-3ecd5569ebad_d10d39ff-9fd6-49a2-b736-ce83f904708e.html,,,,,, "1,1,1,2,3,3,3-heptafluoropropane",431-89-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2c49e7e-2af1-4c76-8c83-5faf68380b4d/documents/IUC5-fd4db634-bcfc-47c7-a5a2-3ecd5569ebad_d10d39ff-9fd6-49a2-b736-ce83f904708e.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"731,690 mg/m3",, "1,1,1,2,3,3,3-heptafluoropropane",431-89-0,"Animal studies show that 1,1,1,2,3,3,3-heptafluoropropane (HFC 227ea) has low acute inhalational toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2c49e7e-2af1-4c76-8c83-5faf68380b4d/documents/IUC5-75e35905-1523-4f80-b883-ffda9d75df8c_d10d39ff-9fd6-49a2-b736-ce83f904708e.html,,,,,, "1,1,1,2,3,3,3-heptafluoropropane",431-89-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2c49e7e-2af1-4c76-8c83-5faf68380b4d/documents/IUC5-75e35905-1523-4f80-b883-ffda9d75df8c_d10d39ff-9fd6-49a2-b736-ce83f904708e.html,,inhalation,LC50,"5,483,776 mg/m3",, "4,4'-isopropylidenedicyclohexanol",80-04-6, NOAEL: 300 mg/kg/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d1341bf-5df8-46ac-b5b3-f30cdcb57353/documents/IUC5-189df55f-0ce9-41b8-b4c4-4bf0ea38a2ed_1a58c8e7-abf1-47b9-b862-6c67a20db8fb.html,,,,,, "4,4'-isopropylidenedicyclohexanol",80-04-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d1341bf-5df8-46ac-b5b3-f30cdcb57353/documents/IUC5-189df55f-0ce9-41b8-b4c4-4bf0ea38a2ed_1a58c8e7-abf1-47b9-b862-6c67a20db8fb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "4,4'-isopropylidenedicyclohexanol",80-04-6, Neither the derrmal nor the oral study indicated any toxicity in these studies. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d1341bf-5df8-46ac-b5b3-f30cdcb57353/documents/IUC5-b45d3653-8f57-41df-abc9-6b5fd6aae913_1a58c8e7-abf1-47b9-b862-6c67a20db8fb.html,,,,,, "4,4'-isopropylidenedicyclohexanol",80-04-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d1341bf-5df8-46ac-b5b3-f30cdcb57353/documents/IUC5-b45d3653-8f57-41df-abc9-6b5fd6aae913_1a58c8e7-abf1-47b9-b862-6c67a20db8fb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-isopropylidenedicyclohexanol",80-04-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d1341bf-5df8-46ac-b5b3-f30cdcb57353/documents/IUC5-b45d3653-8f57-41df-abc9-6b5fd6aae913_1a58c8e7-abf1-47b9-b862-6c67a20db8fb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Dec-1-ene, dimers, hydrogenated",68649-11-6,"Twelve, 28-day oral exposure studies (OECD 407/422) and three 90-day oral exposure studies (OECD 408/OECD 415) were identified either within category or from a structural analogue. There were no key dermal or inhalation repeated dose studies identified.   Overall, the 28-day exposure studies found no toxicity when the respective poly alpha olefins were administered orally. Results were as follows.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dec-1-ene, dimers.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dec-1-ene, trimers, hydrogenated.   The NOAEL is 6245 mg/kg/day in male rats and 6771 mg/kg/day in female rats for the 28-day oral repeated dose study from dec-1-ene, homopolymer, hydrogenated.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dodec-1-ene, dimers.   The NOEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from dodec-1-ene, dimer, hydrogenated. The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dodec-1-ene, dimers, hydrogenated.   The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from dodec-1-ene, trimer, hydrogenated.   The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from dodec-1-ene, dimer with dec-1-ene, hydrogenated.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dodec-1-ene, homopolymer, hydrogenated.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested tetradec-1-ene, dimers, hydrogenated.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested Alkene, polymer with 1-dodecene, distn. Residues, hydrogenated, C24-56 fraction.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested tetradec-1-ene, polymer with dod-1-ecene, distn. residues, hydrogenated, C36-84 fraction.   For the 90-day oral exposure studies, results were as follows.   The NOAEL is 4159.4 mg/kg bw in male rats and 4619.9 mg/kg bw in female rats for the 90-day exposure study from dec-1-ene, homopolymer, hydrogenated.   The NOAEL is 1000 mg/kg bw in male and female rats for the 91-day exposure study from dec-1-ene, homopolymer, hydrogenated.   The NOAEL is 1000 mg/kg bw in male and female rats for the 90-day one-generation reproduction study with sub-chronic toxicity from dodec-1-ene, trimer, hydrogenated. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/81359562-6358-4da2-912d-830a2e2d949c/documents/9a83365f-cd81-4270-a29d-36cac074fbd2_66fb4d60-1bd7-41fd-a62f-37a018f08f39.html,,,,,, "Dec-1-ene, dimers, hydrogenated",68649-11-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/81359562-6358-4da2-912d-830a2e2d949c/documents/9a83365f-cd81-4270-a29d-36cac074fbd2_66fb4d60-1bd7-41fd-a62f-37a018f08f39.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Dec-1-ene, dimers, hydrogenated",68649-11-6,"Eight key acute oral toxicity studies (OECD 401 and OECD 420) and five key acute dermal toxicity studies (OECD 402) were identified for numerous poly alpha olefins that showed similar acute oral and dermal toxicity results.   Eight key/weight of evidence acute inhalation studies (OECD 403) were identified for poly alpha olefins.   Acute Oral   The oral LD50 was determined to be > 5000 mg/kg bw in male and female rats for dec-1-ene, dimers, hydrogenated; dec-1-ene, homopolymer, hydrogenated; dec-1-ene, tetramer, mixed with dec-1-ene, trimer, hydrogenated; dodec-1-ene, dimer, hydrogenated; dodec-1-ene, dimer with dec-1-ene, hydrogenated; dodec-1-ene, trimer, hydrogenated; and dodec-1-ene, polymer with dec-1-ene.   The oral LD50 was determined to be >2000 mg/kg bw in male and female rats for dec-1-ene, trimers, hydrogenated.   Acute Inhalation   The inhalation LC50 value for oct-1-ene, dimer, hydrogenated in male and female rats was reported to be >1.05 – <2.09 mg/L.   The inhalation LC50 values for dec-1-ene, dimers, hydrogenated in male and female rats were all reported as < 5.0 mg/L.   The inhalation LC50 value for dec-1-ene, homopolymer, hydrogenated in male and female rats was reported to be >5.2 mg/L.   The inhalation LC50 value for dodec-1-ene, dimers, hydrogenated in male rats was reported to be >5.06 mg/L while that for female rats was reported to be 1.71 mg/L.   The inhalation LC50 value for dodec-1-ene, trimers, hydrogenated in male and female rats was reported to be >5.06 mg/L.   The inhalation LC50 value for dodec-1-ene, polymer with dec-1-ene, hydrogenated in male and female rats was reported to be >5.0 mg/L.   Acute Dermal   The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for dec-1-ene, dimers, hydrogenated.   The dermal LD50 was > 2000 mg/kg/bw in male and female rats for dec-1-ene and dodec-1-ene, homopolymer; dodec-1-ene, dimers, hydrogenated; dodec-1-ene, trimers, hydrogenated; and dodec-1-ene, dimer with dec-1-ene, hydrogenated. Dec-1-ene, dimers, hydrogenated is classified for aspiration toxicity based on its kinematic viscosity of 5.1 cSt at 40°C. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81359562-6358-4da2-912d-830a2e2d949c/documents/80d5bf56-b5ab-4d0a-ac26-3365553cedbf_66fb4d60-1bd7-41fd-a62f-37a018f08f39.html,,,,,, "Dec-1-ene, dimers, hydrogenated",68649-11-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81359562-6358-4da2-912d-830a2e2d949c/documents/80d5bf56-b5ab-4d0a-ac26-3365553cedbf_66fb4d60-1bd7-41fd-a62f-37a018f08f39.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Dec-1-ene, dimers, hydrogenated",68649-11-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81359562-6358-4da2-912d-830a2e2d949c/documents/80d5bf56-b5ab-4d0a-ac26-3365553cedbf_66fb4d60-1bd7-41fd-a62f-37a018f08f39.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Dec-1-ene, dimers, hydrogenated",68649-11-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81359562-6358-4da2-912d-830a2e2d949c/documents/80d5bf56-b5ab-4d0a-ac26-3365553cedbf_66fb4d60-1bd7-41fd-a62f-37a018f08f39.html,,inhalation,LC50,< 5 mg/L,adverse effect observed, A mixture of isomers of branched tetracosane,151006-61-0,"Twelve, 28-day oral exposure studies (OECD 407/422) and three 90-day oral exposure studies (OECD 408/OECD 415) were identified either within category or from a structural analogue. There were no key dermal or inhalation repeated dose studies identified.   Overall, the 28-day exposure studies found no toxicity when the respective poly alpha olefins were administered orally. Results were as follows.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dec-1-ene, dimers.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dec-1-ene, trimers, hydrogenated.   The NOAEL is 6245 mg/kg/day in male rats and 6771 mg/kg/day in female rats for the 28-day oral repeated dose study from dec-1-ene, homopolymer, hydrogenated.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dodec-1-ene, dimers.   The NOEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from dodec-1-ene, dimer, hydrogenated. The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dodec-1-ene, dimers, hydrogenated.   The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from dodec-1-ene, trimer, hydrogenated.   The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from dodec-1-ene, dimer with dec-1-ene, hydrogenated.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dodec-1-ene, homopolymer, hydrogenated.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested tetradec-1-ene, dimers, hydrogenated.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested Alkene, polymer with 1-dodecene, distn. Residues, hydrogenated, C24-56 fraction.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested tetradec-1-ene, polymer with dod-1-ecene, distn. residues, hydrogenated, C36-84 fraction.   For the 90-day oral exposure studies, results were as follows.   The NOAEL is 4159.4 mg/kg bw in male rats and 4619.9 mg/kg bw in female rats for the 90-day exposure study from dec-1-ene, homopolymer, hydrogenated.   The NOAEL is 1000 mg/kg bw in male and female rats for the 91-day exposure study from dec-1-ene, homopolymer, hydrogenated.   The NOAEL is 1000 mg/kg bw in male and female rats for the 90-day one-generation reproduction study with sub-chronic toxicity from dodec-1-ene, trimer, hydrogenated. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5df18121-34f5-4b43-995d-e386c4b7e809/documents/15e00418-48e6-4245-bf8b-779bb75be01f_7ea76168-7b62-404e-9d8f-cff08586f069.html,,,,,, A mixture of isomers of branched tetracosane,151006-61-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5df18121-34f5-4b43-995d-e386c4b7e809/documents/15e00418-48e6-4245-bf8b-779bb75be01f_7ea76168-7b62-404e-9d8f-cff08586f069.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat A mixture of isomers of branched tetracosane,151006-61-0,"Eight key acute oral toxicity studies (OECD 401 and OECD 420) and five key acute dermal toxicity studies (OECD 402) were identified for numerous poly alpha olefins that showed similar acute oral and dermal toxicity results.   Eight key acute inhalation studies (OECD 403) were identified for poly alpha olefins.   Acute Oral   The oral LD50 was determined to be > 5000 mg/kg bw in male and female rats for dec-1-ene, dimers, hydrogenated; dec-1-ene, homopolymer, hydrogenated; dec-1-ene, tetramer, mixed with dec-1-ene, trimer, hydrogenated; dodec-1-ene, dimer, hydrogenated; dodec-1-ene, dimer with dec-1-ene, hydrogenated; dodec-1-ene, trimer, hydrogenated; and dodec-1-ene, polymer with dec-1-ene.   The oral LD50 was determined to be >2000 mg/kg bw in male and female rats for dec-1-ene, trimers, hydrogenated.   Acute Inhalation   The inhalation LC50 value for oct-1-ene, dimer, hydrogenated in male and female rats was reported to be >1.05 – <2.09 mg/L.   The inhalation LC50 values for dec-1-ene, dimers, hydrogenated in male and female rats were all reported as < 5.0 mg/L.   The inhalation LC50 value for dec-1-ene, homopolymer, hydrogenated in male and female rats was reported to be >5.2 mg/L.   The inhalation LC50 value for dodec-1-ene, dimers, hydrogenated in male rats was reported to be >5.06 mg/L while that for female rats was reported to be 1.71 mg/L.   The inhalation LC50 value for dodec-1-ene, trimers, hydrogenated in male and female rats was reported to be >5.06 mg/L.   The inhalation LC50 value for dodec-1-ene, polymer with dec-1-ene, hydrogenated in male and female rats was reported to be >5.0 mg/L.   Acute Dermal   The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for dec-1-ene, dimers, hydrogenated.   The dermal LD50 was > 2000 mg/kg/bw in male and female rats for dec-1-ene and dodec-1-ene, homopolymer; dodec-1-ene, dimers, hydrogenated; dodec-1-ene, trimers, hydrogenated; and dodec-1-ene, dimer with dec-1-ene, hydrogenated. Dodec-1-ene, dimers, hydrogenated with a kinematic viscosity of <20.5 cSt at 40°C meet the requirement for classification (H304) for aspiration toxicity under the EU CLP regulation. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5df18121-34f5-4b43-995d-e386c4b7e809/documents/21c51a7e-59c2-4dd3-ac04-8ec21c424f7b_7ea76168-7b62-404e-9d8f-cff08586f069.html,,,,,, A mixture of isomers of branched tetracosane,151006-61-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5df18121-34f5-4b43-995d-e386c4b7e809/documents/21c51a7e-59c2-4dd3-ac04-8ec21c424f7b_7ea76168-7b62-404e-9d8f-cff08586f069.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, A mixture of isomers of branched tetracosane,151006-61-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5df18121-34f5-4b43-995d-e386c4b7e809/documents/21c51a7e-59c2-4dd3-ac04-8ec21c424f7b_7ea76168-7b62-404e-9d8f-cff08586f069.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, A mixture of isomers of branched tetracosane,151006-61-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5df18121-34f5-4b43-995d-e386c4b7e809/documents/21c51a7e-59c2-4dd3-ac04-8ec21c424f7b_7ea76168-7b62-404e-9d8f-cff08586f069.html,,inhalation,LC50,ca.1.71 mg/L,adverse effect observed, "2,6,10-Trimethyldodecane (Farnesane)",3891-98-3," A 90 day toxicity study with Farnesane was performed by oral route using male and female rats. The oral administration of Farnesane to rats by gavage, at dose levels of 10, 100 and 1000 mg/Kg bw/day, did not result in any significant adverse toxicological effects. Therefore, the ‘No Observed Adverse Effect Level’ (NOAEL) was not derived. The ‘No Observed Effect Level’ (NOEL) for systemic toxicity was therefore considered to be 1000 mg/Kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18117a83-17a2-4e06-beb4-4964b8c2a324/documents/IUC5-cf7d0e34-c124-4310-9dc4-68fb1dcea945_b9f34797-a7b9-48fd-abd0-ef1887d21906.html,,,,,, "2,6,10-Trimethyldodecane (Farnesane)",3891-98-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18117a83-17a2-4e06-beb4-4964b8c2a324/documents/IUC5-cf7d0e34-c124-4310-9dc4-68fb1dcea945_b9f34797-a7b9-48fd-abd0-ef1887d21906.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,6,10-Trimethyldodecane (Farnesane)",3891-98-3,1) Oral LD50 > 5000 mg/Kg 2) Inhalation LC50 > 2.19 mg/L3) Dermal LD50 > 5000 mg/Kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18117a83-17a2-4e06-beb4-4964b8c2a324/documents/IUC5-9f14003a-f7af-468a-8840-696c0b46567e_b9f34797-a7b9-48fd-abd0-ef1887d21906.html,,,,,, "2,6,10-Trimethyldodecane (Farnesane)",3891-98-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18117a83-17a2-4e06-beb4-4964b8c2a324/documents/IUC5-9f14003a-f7af-468a-8840-696c0b46567e_b9f34797-a7b9-48fd-abd0-ef1887d21906.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2,6,10-Trimethyldodecane (Farnesane)",3891-98-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18117a83-17a2-4e06-beb4-4964b8c2a324/documents/IUC5-9f14003a-f7af-468a-8840-696c0b46567e_b9f34797-a7b9-48fd-abd0-ef1887d21906.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2,6,10-Trimethyldodecane (Farnesane)",3891-98-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18117a83-17a2-4e06-beb4-4964b8c2a324/documents/IUC5-9f14003a-f7af-468a-8840-696c0b46567e_b9f34797-a7b9-48fd-abd0-ef1887d21906.html,,inhalation,discriminating conc.,"2,190 ",no adverse effect observed, "Lanolin, hydrogenated",8031-44-5, LD50 (oral) > 2000 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/731bf57e-2216-4f98-94c0-64562b0147d1/documents/80a89d48-02ac-472e-ac54-ac024fab7d55_29465e08-9e04-497c-a8d6-688535d3bd57.html,,,,,, "Lanolin, hydrogenated",8031-44-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/731bf57e-2216-4f98-94c0-64562b0147d1/documents/80a89d48-02ac-472e-ac54-ac024fab7d55_29465e08-9e04-497c-a8d6-688535d3bd57.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Lecithins, hydrogenated",92128-87-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/442400c0-f4b7-416f-a5fb-6dcf3740af2b/documents/6620fa54-6b91-4498-ab77-293043484b44_ef739ffa-c6c1-4051-91e9-644ea06fdd58.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"4,860 mg/kg bw/day",,rat "Lecithins, hydrogenated",92128-87-5," Acute toxicity via oral route: An OECD 401 test was performed on hydrogentated lecithins. Under the experimental conditions employed, the test substance, administered orally at a dose rate 2g/kg, failed to lead to any mortality. The autopsy of the animals at the end of the trial failed to evidence any macroscopic lesions that could be related to a tox effect of the product. The minimal lethal dose of the product is therefore : greater than 2g / kg in the Sprague Dawley rat, when administered in a single, oral dose. Acute toxicity via inhalation route: read across on acetylated lecithins Several attempts were made to generate a respirable 2-5 mg/L atmosphere of the test substance. Due to the high viscosity of the test substance, a respirable atmosphere could not be generated. To facilitate test substance atmosphere generation, the test substance was diluted 50:50 (v/v) with corn oil. Chamber trials demonstrated a respirable atmosphere around 2.0 mg/L could be generated with test substance:corn oil 50:50 (v/v). Two groups of 5 male and 5 female Crl:CD(SD) rats were exposed nose-only for a single 4-hour period to either the vehicle corn oil or a 50:50 (v/v) mixture of test substance:corn oil in air. Animals were weighed and observed for clinical signs of toxicity during a 14-day recovery period. Rats were exposed to an aerosol concentration of 2.5 ± 1.2 mg/L corn oil (mean ± standard deviation; vehicle control).   All rats exposed to 2.5 mg/L corn oil (vehicle control) survived the exposure and the subsequent 14-day recovery period. Animals demonstrated no loss in body weight, 1, 7 or 14 days post exposure and no clinical signs of toxicity were observed. Gross pathological examination revealed no evidence of organ-specific toxicity in any of the rats 14 days following the 4-hour exposure to 2.5 mg/L corn oil. All rats exposed to 2.9 mg/L test substance:corn oil 50:50 (v/v) survived the exposure and the subsequent 14-day recovery period. Animals demonstrated no loss in body weight 1, 7 or 14 days post exposure and no clinical signs of toxicity were observed. Gross pathological examination revealed no evidence of organ-specific toxicity in any of the rats 14 days following the 2.9 mg/L test substance:corn oil 50:50 (v/v). Under the conditions of this study, the 4-hour inhalation median lethal concentration (LC50) for the test substance in male and female rats was greater than 0.89 mg/L, the maximum practically attainable atmospheric aerosol concentration. Acute toxicity via dermal route: No study performed since the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/442400c0-f4b7-416f-a5fb-6dcf3740af2b/documents/113ff94d-ac43-443d-be1e-8123fde152d0_ef739ffa-c6c1-4051-91e9-644ea06fdd58.html,,,,,, "Lecithins, hydrogenated",92128-87-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/442400c0-f4b7-416f-a5fb-6dcf3740af2b/documents/113ff94d-ac43-443d-be1e-8123fde152d0_ef739ffa-c6c1-4051-91e9-644ea06fdd58.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Lecithins, hydrogenated",92128-87-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/442400c0-f4b7-416f-a5fb-6dcf3740af2b/documents/113ff94d-ac43-443d-be1e-8123fde152d0_ef739ffa-c6c1-4051-91e9-644ea06fdd58.html,,inhalation,LC50,890 mg/m3,no adverse effect observed, "Paraffin waxes and Hydrocarbon waxes, microcryst., hydrotreated",92045-76-6,"Paraffin and hydrocarbon waxes were found to be of low acute toxicity by the oral, and dermal routes.  There are no reports of acute inhalation toxicity studies of paraffin and hydrocarbon waxes; however, due to the very low vapour pressures of these substances, exposure by inhalation is not expected. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2ec31b4-5482-46eb-820e-06d33a498bda/documents/f15719c3-410b-4c16-9d58-061adb431c23_6d98ef27-61e7-4eaf-a3bb-07055e53146f.html,,,,,, "Paraffin waxes and Hydrocarbon waxes, microcryst., hydrotreated",92045-76-6,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2ec31b4-5482-46eb-820e-06d33a498bda/documents/f15719c3-410b-4c16-9d58-061adb431c23_6d98ef27-61e7-4eaf-a3bb-07055e53146f.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rat "Paraffin waxes and Hydrocarbon waxes, microcryst., hydrotreated",92045-76-6,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2ec31b4-5482-46eb-820e-06d33a498bda/documents/f15719c3-410b-4c16-9d58-061adb431c23_6d98ef27-61e7-4eaf-a3bb-07055e53146f.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,500 mg/kg bw/day",,rat "Paraffin waxes and Hydrocarbon waxes, microcryst., hydrotreated",92045-76-6,The acute toxicity of paraffin and hydrocarbon waxes is low with no observed mortalities from oral (OECD 401/420) or dermal (OECD 402) applications. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2ec31b4-5482-46eb-820e-06d33a498bda/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_6d98ef27-61e7-4eaf-a3bb-07055e53146f.html,,,,,, "Paraffin waxes and Hydrocarbon waxes, microcryst., hydrotreated",92045-76-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2ec31b4-5482-46eb-820e-06d33a498bda/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_6d98ef27-61e7-4eaf-a3bb-07055e53146f.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Paraffin waxes and Hydrocarbon waxes, microcryst., hydrotreated",92045-76-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2ec31b4-5482-46eb-820e-06d33a498bda/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_6d98ef27-61e7-4eaf-a3bb-07055e53146f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbon waxes (petroleum), hydrotreated microcryst.",64742-60-5,"Paraffin and hydrocarbon waxes were found to be of low acute toxicity by the oral, and dermal routes.  There are no reports of acute inhalation toxicity studies of paraffin and hydrocarbon waxes; however, due to the very low vapour pressures of these substances, exposure by inhalation is not expected. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ffff51bb-46c1-49fa-8c1d-811545331698/documents/f15719c3-410b-4c16-9d58-061adb431c23_037b5d80-b31f-4ff2-97f9-11a34efeec73.html,,,,,, "Hydrocarbon waxes (petroleum), hydrotreated microcryst.",64742-60-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ffff51bb-46c1-49fa-8c1d-811545331698/documents/f15719c3-410b-4c16-9d58-061adb431c23_037b5d80-b31f-4ff2-97f9-11a34efeec73.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rat "Hydrocarbon waxes (petroleum), hydrotreated microcryst.",64742-60-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ffff51bb-46c1-49fa-8c1d-811545331698/documents/f15719c3-410b-4c16-9d58-061adb431c23_037b5d80-b31f-4ff2-97f9-11a34efeec73.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,500 mg/kg bw/day",,rat "Hydrocarbon waxes (petroleum), hydrotreated microcryst.",64742-60-5,The acute toxicity of paraffin and hydrocarbon waxes is low with no observed mortalities from oral (OECD 401/420) or dermal (OECD 402) applications. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ffff51bb-46c1-49fa-8c1d-811545331698/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_037b5d80-b31f-4ff2-97f9-11a34efeec73.html,,,,,, "Hydrocarbon waxes (petroleum), hydrotreated microcryst.",64742-60-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ffff51bb-46c1-49fa-8c1d-811545331698/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_037b5d80-b31f-4ff2-97f9-11a34efeec73.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrocarbon waxes (petroleum), hydrotreated microcryst.",64742-60-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ffff51bb-46c1-49fa-8c1d-811545331698/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_037b5d80-b31f-4ff2-97f9-11a34efeec73.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated heavy paraffinic",64742-54-7,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acedb8e8-0751-48ce-a515-68ab926b7e91/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_df19c149-623b-4e35-adcb-580a4ae80f68.html,,,,,, "Distillates (petroleum), hydrotreated heavy paraffinic",64742-54-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acedb8e8-0751-48ce-a515-68ab926b7e91/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_df19c149-623b-4e35-adcb-580a4ae80f68.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Distillates (petroleum), hydrotreated heavy paraffinic",64742-54-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acedb8e8-0751-48ce-a515-68ab926b7e91/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_df19c149-623b-4e35-adcb-580a4ae80f68.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Distillates (petroleum), hydrotreated heavy paraffinic",64742-54-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acedb8e8-0751-48ce-a515-68ab926b7e91/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_df19c149-623b-4e35-adcb-580a4ae80f68.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Distillates (petroleum), hydrotreated heavy paraffinic",64742-54-7,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acedb8e8-0751-48ce-a515-68ab926b7e91/documents/73761dae-46d6-428e-8e40-e5cc70088d96_df19c149-623b-4e35-adcb-580a4ae80f68.html,,,,,, "Distillates (petroleum), hydrotreated heavy paraffinic",64742-54-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acedb8e8-0751-48ce-a515-68ab926b7e91/documents/73761dae-46d6-428e-8e40-e5cc70088d96_df19c149-623b-4e35-adcb-580a4ae80f68.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated heavy paraffinic",64742-54-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acedb8e8-0751-48ce-a515-68ab926b7e91/documents/73761dae-46d6-428e-8e40-e5cc70088d96_df19c149-623b-4e35-adcb-580a4ae80f68.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated heavy paraffinic",64742-54-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acedb8e8-0751-48ce-a515-68ab926b7e91/documents/73761dae-46d6-428e-8e40-e5cc70088d96_df19c149-623b-4e35-adcb-580a4ae80f68.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Fatty acids, palm-oil, hydrogenated",84238-17-5,"Oral NOAEL for risk assessment purposes: 15% in feed, equivalent to an estimated 7,500 mg/kg bw/day. Dermal exposure and DNEL to be based on the oral NOAEL.No significant respiratory exposure. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4817c7f8-8c18-462c-881c-89722b011f64/documents/IUC5-8236bc39-5f37-4694-a5df-397ede48159b_4147aac7-791f-4f4d-8ca0-6391b6ffd17d.html,,,,,, "Fatty acids, palm-oil, hydrogenated",84238-17-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4817c7f8-8c18-462c-881c-89722b011f64/documents/IUC5-8236bc39-5f37-4694-a5df-397ede48159b_4147aac7-791f-4f4d-8ca0-6391b6ffd17d.html,Chronic toxicity – systemic effects,oral,NOAEL,"7,500 mg/kg bw/day",,rat "Fatty acids, palm-oil, hydrogenated",84238-17-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4817c7f8-8c18-462c-881c-89722b011f64/documents/IUC5-f6d5d474-75dc-4622-bef9-923db73f503d_4147aac7-791f-4f4d-8ca0-6391b6ffd17d.html,,oral,LD50,"5,000 mg/kg bw",, "Fatty acids, palm-oil, hydrogenated",84238-17-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4817c7f8-8c18-462c-881c-89722b011f64/documents/IUC5-f6d5d474-75dc-4622-bef9-923db73f503d_4147aac7-791f-4f4d-8ca0-6391b6ffd17d.html,,dermal,LD50,"2,000 mg/kg bw",, "Phosphatidylcholines, soya, hydrogenated",97281-48-6, The effects of chronic exposure to liposome aerosols on lung histology and alveolar macrophage function were studied in BALB/C mice. 1 -3µg of lipid inhaled per dosing per mouse was estimated from fluorescence measurements. No histological changes of the lungs or untoward effects on general health or survival of animals were noted. Alveolar macrophage phagocytic function was not affected. Transmission electron microscopy and morphometry showed no treatment related alterations. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83a4cb35-680a-4f03-891b-7722340eb99d/documents/522cd7a4-4260-40f0-8fcb-bf1860c12d13_1029abd4-c119-4a9f-a13e-7e8d70e28083.html,,,,,, "Phosphatidylcholines, soya, hydrogenated",97281-48-6," The acute oral toxicity of Phosphatidylcholine hydrogenated was investigated in one group of fasted male and female NMRI mice and WISW rats. The mice and rats were exposed to a single oral dose of the test item (10 g/kg) and observed for 14 days post exposure. No mortality, weight changes, no clinical signs nor macroscopic changes were found in NMRI mice or WISW rats exposed to the test item (10 g/kg). LD50 is therefore reported as > 10 g/kg. The acute dermal toxicity of the substance Phosphatidylcholines, soya, hydrogenated is assessed in a weight of evidence approach using available data on the group of lecithins. Dermal acute toxicity is assessed based on the low oral acute toxicity and a study with phosphatidylserine administrated subcutaneously reporting the LD50 value to be greater than 5 mg/kg bodyweight. All available studies on acute toxicity by other routes show a low acute toxicity of phosphatidylcholines, soya, hydrogenated and lecithins, with a LD50 of more than 4000 mg/kg bw. Although a relatively high dermal absorption of lecithins have been shown, the potential of acute dermal toxicity is evaluated to be low due to the high LD50 values reported. The overall conclusion based on presented data in this weight of evidence analysis, is that there are no indications of acute dermal toxicity of the substance Phosphatidylcholines, soya, hydrogenated. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83a4cb35-680a-4f03-891b-7722340eb99d/documents/d410bdc3-d5a5-4cf3-9a17-2a9bfb6bfd05_1029abd4-c119-4a9f-a13e-7e8d70e28083.html,,,,,, "Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated",68037-01-4,"Twelve, 28-day oral exposure studies (OECD 407/422) and three 90-day oral exposure studies (OECD 408/OECD 415) were identified either within category or from a structural analogue. There were no key dermal or inhalation repeated dose studies identified.   Overall, the 28-day exposure studies found no toxicity when the respective poly alpha olefins were administered orally. Results were as follows.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dec-1-ene, dimers.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dec-1-ene, trimers, hydrogenated.   The NOAEL is 6245 mg/kg/day in male rats and 6771 mg/kg/day in female rats for the 28-day oral repeated dose study from dec-1-ene, homopolymer, hydrogenated.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dodec-1-ene, dimers.   The NOEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from dodec-1-ene, dimer, hydrogenated. The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dodec-1-ene, dimers, hydrogenated.   The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from dodec-1-ene, trimer, hydrogenated.   The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from dodec-1-ene, dimer with dec-1-ene, hydrogenated.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dodec-1-ene, homopolymer, hydrogenated.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested tetradec-1-ene, dimers, hydrogenated.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested Alkene, polymer with 1-dodecene, distn. Residues, hydrogenated, C24-56 fraction.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested tetradec-1-ene, polymer with dod-1-ecene, distn. residues, hydrogenated, C36-84 fraction.   For the 90-day oral exposure studies, results were as follows.   The NOAEL is 4159.4 mg/kg bw in male rats and 4619.9 mg/kg bw in female rats for the 90-day exposure study from dec-1-ene, homopolymer, hydrogenated.   The NOAEL is 1000 mg/kg bw in male and female rats for the 91-day exposure study from dec-1-ene, homopolymer, hydrogenated.   The NOAEL is 1000 mg/kg bw in male and female rats for the 90-day one-generation reproduction study with sub-chronic toxicity from dodec-1-ene, trimer, hydrogenated. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03039ccc-978b-4e67-90ec-166b52ef2804/documents/d15fac3a-2915-4f41-9a7d-907e9e953b8f_08f9a5a6-3e3b-4840-b96f-41eb4db42092.html,,,,,, "Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated",68037-01-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03039ccc-978b-4e67-90ec-166b52ef2804/documents/d15fac3a-2915-4f41-9a7d-907e9e953b8f_08f9a5a6-3e3b-4840-b96f-41eb4db42092.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated",68037-01-4,"Eight key acute oral toxicity studies (OECD 401 and OECD 420) and five key acute dermal toxicity studies (OECD 402) were identified for numerous poly alpha olefins that showed similar acute oral and dermal toxicity results.   Eight key/weight of evidence acute inhalation studies (OECD 403) were identified for poly alpha olefins.   Acute Oral   The oral LD50 was determined to be > 5000 mg/kg bw in male and female rats for dec-1-ene, dimers, hydrogenated; dec-1-ene, homopolymer, hydrogenated; dec-1-ene, tetramer, mixed with dec-1-ene, trimer, hydrogenated; dodec-1-ene, dimer, hydrogenated; dodec-1-ene, dimer with dec-1-ene, hydrogenated; dodec-1-ene, trimer, hydrogenated; and dodec-1-ene, polymer with dec-1-ene.   The oral LD50 was determined to be >2000 mg/kg bw in male and female rats for dec-1-ene, trimers, hydrogenated.   Acute Inhalation   The inhalation LC50 value for oct-1-ene, dimer, hydrogenated in male and female rats was reported to be >1.05 – <2.09 mg/L.   The inhalation LC50 values for dec-1-ene, dimers, hydrogenated in male and female rats were all reported as < 5.0 mg/L.   The inhalation LC50 value for dec-1-ene, homopolymer, hydrogenated in male and female rats was reported to be >5.2 mg/L.   The inhalation LC50 value for dodec-1-ene, dimers, hydrogenated in male rats was reported to be >5.06 mg/L while that for female rats was reported to be 1.71 mg/L.   The inhalation LC50 value for dodec-1-ene, trimers, hydrogenated in male and female rats was reported to be >5.06 mg/L.   The inhalation LC50 value for dodec-1-ene, polymer with dec-1-ene, hydrogenated in male and female rats was reported to be >5.0 mg/L.   Acute Dermal   The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for dec-1-ene, dimers, hydrogenated.   The dermal LD50 was > 2000 mg/kg/bw in male and female rats for dec-1-ene and dodec-1-ene, homopolymer; dodec-1-ene, dimers, hydrogenated; dodec-1-ene, trimers, hydrogenated; and dodec-1-ene, dimer with dec-1-ene, hydrogenated. Dec-1-ene, homopolymer, hydrogenated substances with kinematic viscosities <20.5 cSt at 40°C meet the criteria for classification and labelling under EU CLP Regulation 1272/2008 (GHS aligned) as a Category 1 (H304) aspiration toxicant.   Dec-1-ene, homopolymer, hydrogenated substances with kinematic viscosities  >20.5 cSt 40°C are not classified for any physical, human health, or environmental endpoint under EU CLP Regulation 1272/2008 (GHS aligned).  ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03039ccc-978b-4e67-90ec-166b52ef2804/documents/519e5f26-8453-46f9-b8c0-6efc961fae12_08f9a5a6-3e3b-4840-b96f-41eb4db42092.html,,,,,, "Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated",68037-01-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03039ccc-978b-4e67-90ec-166b52ef2804/documents/519e5f26-8453-46f9-b8c0-6efc961fae12_08f9a5a6-3e3b-4840-b96f-41eb4db42092.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated",68037-01-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03039ccc-978b-4e67-90ec-166b52ef2804/documents/519e5f26-8453-46f9-b8c0-6efc961fae12_08f9a5a6-3e3b-4840-b96f-41eb4db42092.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Dec-1-ene, homopolymer, hydrogenated Dec-1-ene, oligomers, hydrogenated",68037-01-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03039ccc-978b-4e67-90ec-166b52ef2804/documents/519e5f26-8453-46f9-b8c0-6efc961fae12_08f9a5a6-3e3b-4840-b96f-41eb4db42092.html,,inhalation,LC50,> 5.2 mg/L,no adverse effect observed, "Rosin, hydrogenated",65997-06-0," Several key guideline (OECD 408, 414, 421, & 422 ) studies that investigated the repeated dose toxicity potential of Rosin; Rosin, hydrogenated; Rosin, oligomers; and Rosin, reaction products with formaldehyde following oral dietary exposure in rats are available. The results are summarized below: OECD 408 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL was determined to be 5000 ppm (equivalent to a mean achieved dosage of 335.2 mg/kg bw/day for males and 401.2 mg/kg bw/day for females) based on reduced body weight gains in animals of either sex exposed to 7500 ppm. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The NOAEL for systemic toxicity of Rosin, reaction products with formaldehyde was considered to be 3000 ppm (equivalent to mean achieved dosages of approximately 213.1 mg/kg bw/day or 255.2 mg/kg bw/day for males and females, respectively), based on the effects on body weight, body weight gain and, to a lesser extent, food consumption, observed among females exposed to diets containing 7500 ppm of the test material for ninety days. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): Based on a lack of adverse treatment-related effects observed at the highest concentration tested, the systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 6000 ppm for either sex (equivalent to a mean achieved dosage of 334.5 mg/kg bw/day for males and 399.8 mg/kg bw/day for females). OECD 414 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 2500 ppm (equivalent to a mean achieved dosage of 199.3 mg/kg bw/day) based on lower maternal body weight gain during gestation and an initial effect on food consumption at 7500 ppm and lower maternal body weight gain at 5000 ppm. OECD 421 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 1000 ppm in males (equivalent to 84 mg/kg bw/d) and 3000 ppm in females (equivalent to 309 mg/kg bw/d) based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material. OECD 422 1) Rosin (CAS# 8050 -09 -7): In a key combined repeated dose, reproductive/developmental toxicity screening study (Harlan Laboratories Ltd, 2015a), the sytemic toxicity NOAEL for Tall oil rosin was determined to be 5000 ppm. In another key combined repeated dose, reproductive/developmental toxicity study (Harlan Laboratories Ltd., 2014a), the systemic toxicity NOAEL for Gum Rosin was determined to be 2500 ppm. A NOEL (No Observed Effect Level) for general toxicity could not be established due to effects on body weights at all dose levels in females during the lactation period. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The systemic toxicity NOAEL for Rosin, reaction product with formaldehyde was determined to be 10000 ppm and the NOEL was established at a concentration of 1000 ppm. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): The systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 3000 ppm. Based on the histopathological changes observed in adrenal glands, no NOEL for systemic toxicity was established for females whereas for males it was at the dose level of 1000 ppm. 4) Rosin, oligomers: The systemic toxicity NOAEL for Rosin, oligomers in male rats was determined to be 7500 ppm, based on statistically significant body weight and body weight gain effects observed at the 15000 ppm concentration level. The systemic toxicity NOAEL for female rats was determined to be 3000 ppm, based on effects on body weight and body weight gain in females exposed to the test material at 7500 and 15000 ppm. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8925fa82-15d7-4660-a546-1355f62b1510/documents/9c0e8210-91fb-4189-a324-19cebcf75e23_056f6027-f5d2-4c40-81e5-ffe6fb1ee4d6.html,,,,,, "Rosin, hydrogenated",65997-06-0,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8925fa82-15d7-4660-a546-1355f62b1510/documents/3bfea4e5-27ca-4d48-86ff-eb71f2042955_056f6027-f5d2-4c40-81e5-ffe6fb1ee4d6.html,,,,,, "Rosin, hydrogenated",65997-06-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8925fa82-15d7-4660-a546-1355f62b1510/documents/3bfea4e5-27ca-4d48-86ff-eb71f2042955_056f6027-f5d2-4c40-81e5-ffe6fb1ee4d6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Rosin, hydrogenated",65997-06-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8925fa82-15d7-4660-a546-1355f62b1510/documents/3bfea4e5-27ca-4d48-86ff-eb71f2042955_056f6027-f5d2-4c40-81e5-ffe6fb1ee4d6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Syrups, corn, hydrogenated",68425-17-2,"According to Annex VIII, column 2, a 28-day study is not required as a suitable (sub-)chronic study is available. In a key 13-week gavage study conducted with Lycasin 80/55, a NOAEL value of 4.95 g/kg body weight/day (limit test, actual ingested) was derived for male and female dogs (Virat, 1982).One (1) key study and 1 supporting study for long term repeated dose toxicity (>=12 months) were identified. In a 52-week repeated dose toxicity study with Malbit® (87% maltitol, 5% sorbitol, 6% maltotriitol, dry substance), the NOAEL of 4.5 g/kg body weight/day was identified for male and female rats (Conz and Fumero, 1989). In a 24-month drinking water study conducted with Lycasin 80/55 (7.0% sorbitol, 52.5% maltitol, 22.5% tri- to hexasaccharides, and 17.5% higher-order hydrogenated saccharides), a NOAEL value of 18% in drinking water (limit test, nominal) was derived for male and female rats (Modderman, 1993; Leroy and Dupas, 1984). Exposure by inhalation or dermal routes are not considered the most relevant route of exposure; no inhalation or dermal studies were identified. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17092e38-b9b4-4598-b377-e498d383394b/documents/62d4aa08-3f90-460f-ab39-f7209a802e42_6faaa42b-b725-43c3-a313-0b95bf7a1c2e.html,,,,,, "Syrups, corn, hydrogenated",68425-17-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17092e38-b9b4-4598-b377-e498d383394b/documents/62d4aa08-3f90-460f-ab39-f7209a802e42_6faaa42b-b725-43c3-a313-0b95bf7a1c2e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"4,500 mg/kg bw/day",, "Syrups, corn, hydrogenated",68425-17-2,"The notifiable substance is of low acute toxicity following oral exposure, with no mortality, clinical signs, or adverse effects on body weight reported in mice and rats at a dose of up to 24.37 g/kg body weight (Dupas, 1982). The notifiable substance is of low toxicity following intravenous and intraperitoneal exposure. No mortalities or clinical signs were observed in male and female mice at an intravenous concentration of 6.39 and 8.15 g/kg body weight, respectively. Likewise, no mortalities or clinical signs were observed in mice or rats at an intraperitoneal concentration of approximately 13 g/kg body weight of Lycasin®. No LD50 value has been identified for Lycasin® for any route of exposure. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17092e38-b9b4-4598-b377-e498d383394b/documents/1106b3b9-6615-4727-82f9-20c2d6965e49_6faaa42b-b725-43c3-a313-0b95bf7a1c2e.html,,,,,, "Quaternary ammonium compounds, (hydrogenated tallow alkyl)trimethyl, chlorides",61788-78-1," Overall, considering the repeated dose studies with the read across substances (e.g., Coco TMAC) as mentioned in the Biocides assessment report, the main critical effects associated with these substances were due to their corrosive properties. The systemic effects such as the reduction of body weight and food consumption were considered to be secondary compared to the corrosive properties of the substances. Therefore, in the absence of ‘true’ systemic effects and in line with the biocides assessment reports, the derivation of a systemic DNEL has been considered to be non-relevant and only a qualitative local risk assessment has been conducted for the test substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef6be397-6841-4396-8df4-ba29921e2473/documents/d7f1e666-ddbb-402b-b349-7362a01d7753_ca5620ca-325e-450d-a3ad-28a868866a3c.html,,,,,, "Quaternary ammonium compounds, (hydrogenated tallow alkyl)trimethyl, chlorides",61788-78-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef6be397-6841-4396-8df4-ba29921e2473/documents/d7f1e666-ddbb-402b-b349-7362a01d7753_ca5620ca-325e-450d-a3ad-28a868866a3c.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rabbit "Quaternary ammonium compounds, (hydrogenated tallow alkyl)trimethyl, chlorides",61788-78-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef6be397-6841-4396-8df4-ba29921e2473/documents/d7f1e666-ddbb-402b-b349-7362a01d7753_ca5620ca-325e-450d-a3ad-28a868866a3c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40.3 mg/kg bw/day,,rat "Quaternary ammonium compounds, (hydrogenated tallow alkyl)trimethyl, chlorides",61788-78-1,"Based on the results of the read across study, the oral LD50 value of the test substance is considered to be 630 mg a.i./kg bw in rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef6be397-6841-4396-8df4-ba29921e2473/documents/4589ad18-41d7-4800-9220-c1b8f6d7ce76_ca5620ca-325e-450d-a3ad-28a868866a3c.html,,,,,, "Quaternary ammonium compounds, (hydrogenated tallow alkyl)trimethyl, chlorides",61788-78-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef6be397-6841-4396-8df4-ba29921e2473/documents/4589ad18-41d7-4800-9220-c1b8f6d7ce76_ca5620ca-325e-450d-a3ad-28a868866a3c.html,,oral,LD50,630 mg/kg bw,adverse effect observed, Branched hexatriacontane,151006-62-1,"Three read-across 28-day oral exposure studies (OECD 407) and three 90-day oral exposure studies (OECD 408/OECD 415) were identified either within category or from a structural analogue. There were no key dermal or inhalation repeated dose studies identified.Overall, the 28-day exposure studies found no toxicity when the respective poly alpha olefins were administered orally. Results were as follows.• The NOAEL is 6245 mg/kg/day in male rats and 6771 mg/kg/day in female rats for the 28-day oral repeated dose study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1-dodecene dimer with 1-decene, hydrogenated.• The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1 -dodecene, trimer.For the 90-day oral exposure studies, results were as follows.• The NOAEL is 4145.4 mg/kg bw in male rats and 4619.9 mg/kg bw in female rats for the 90-day exposure study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg bw in male and female rats for the 91-day exposure study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg bw in male and female rats for the 90-day one-generation reproduction study with subchronic toxicity from 1 -dodecene, trimer. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/213a3c75-938f-4d91-a512-f4d9b01db952/documents/df58ff52-e004-4a2c-8073-4660be9710cd_06728a9a-b559-41f5-ad53-a7f90aaf86dc.html,,,,,, Branched hexatriacontane,151006-62-1,"One key acute oral toxicity study (16 CFR 1500) and one key acute dermal toxicity study (OECD 402) were identified. Additional read-across studies were identified for numerous poly alpha olefins that showed similar acute oral and dermal toxicity results. Eight key acute inhalation studies (OECD 403) were identified for poly alpha olefins; four of which were for dec-1-ene, dimers, hydrogenated. • The oral LD50 was > 5000 mg/kg bw in male and female rats for dec-1-ene, dimers, hydrogenated; 1-dodecene dimer with 1-decene, hydrogenated; 1-decene trimer, hydrogenated and tetramers; 1-decene, homopolymer, hydrogenated; 1 -dodecene, trimer; and 1 -dodcene, polymer with 1 -decene.• The oral LD50 was > 2000 mg/kg bw in male and female rats for decene trimer hydrogenated.• The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for dec-1-ene, dimers, hydrogenated.• The dermal LD50 was > 2000 mg/kg/bw in male and female rats for both 1 -dodecene dimer with 1 -decene, hydrogenated; 1 -dodecene dimer with 1 -decene, hydrogenated;1 -dodecene, trimer; and 1 -dodecene, polymer with 1 -decene. • The inhalation LC50 values for dec-1 -ene, dimers, hydrogenated in male and female rats were all reported as < 5.0 mg/L.• Dodec-1-ene, trimers, hydrogenated is not classified for aspiration toxicity based on its kinematic viscosity at 40°C. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/213a3c75-938f-4d91-a512-f4d9b01db952/documents/c21f7fca-23a2-4668-9395-1656b7c972c3_06728a9a-b559-41f5-ad53-a7f90aaf86dc.html,,,,,, "Protein hydrolyzates, silk",96690-41-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19e37fc1-a6e1-412c-a1ec-ef6604668a0d/documents/537eb7b1-21bc-4970-86cf-6ab9271dcd76_1405931b-20cc-4c8c-88a5-d91ca98f981a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Protein hydrolyzates, silk",96690-41-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19e37fc1-a6e1-412c-a1ec-ef6604668a0d/documents/77844a89-e189-451c-a45a-ffb1e6abdc0a_1405931b-20cc-4c8c-88a5-d91ca98f981a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Cocoa, ext.",84649-99-0,"In the studies documented in CSR, the dietary level(s) of cocoa tested represent amounts far exceeding cocoa consumption by humans. A recent approximation of cocoa powder consumption in 2011 (using cocoa production data from 2011 and EU27 population statistics) approximates European cocoa powder consumption to be 18.5 mg/kg bw day. The above information, as well as the knowledge that a vast majority of the population (including children) regularly consume large quantities of cocoa containing products, clearly indicates that there is no concern regarding the repeated oral toxicity of cocoa.In accordance with the results obtained from the key and supporting studies, cocoa powder is not classified according to CLP i.e. NOEL (or derived/adjusted LOEL) dose/concentration exceeds the guidance value ranges of 10 < C ≤ 100 mg/kg/bw/day, (Regulation (EC) No 1272/2008). [ Please refer CSR 5.6.3] ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0cb7619-43e1-4b87-975c-3b1699bf3029/documents/IUC5-8d746a0c-bc29-41ba-8d92-b223f59fe435_381e8312-44ac-4411-bcf2-5ee3b75cba99.html,,,,,, "Cocoa, ext.",84649-99-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0cb7619-43e1-4b87-975c-3b1699bf3029/documents/IUC5-8d746a0c-bc29-41ba-8d92-b223f59fe435_381e8312-44ac-4411-bcf2-5ee3b75cba99.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,000 mg/kg bw/day",,rabbit "Protein hydrolyzates, vegetable",100209-45-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6c6c616-6608-43c5-a37d-e597da1a61f5/documents/IUC5-13eda0fb-c453-47a3-8d91-92c69b888956_fbb689ca-a0ac-4574-83e7-62d1647fdcdd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Hydroquinone,123-31-9,"Oral toxicity:Subchronic neurotoxicity study, Sprague-Dawley rat, 13 w gavage (5 d/w) at doses of 0, 20, 64 and 200 mg/kg bw/d: NOAEL 20 mg/kg bw/d, LOAEL 64 mg/kg bw/d (observation of tremors as clinical signs in male and female rats) (Topping, 1988, 2007).Combined carcinogenicity and chronic toxicity study, Fischer 344 rat, males, 103 w gavage (5 d/w) at doses of 0, 25 and 50 mg/kg bw/d: NOAEL 25 mg/kg bw/d, LOAEL 50 mg/kg bw/d (decreased body weight, increased severity of chronic progressive nephropathy, significant increase of renal tubuli adenoma; renal findings as sex- and species-specific effect of no toxicological relevance for human risk assessment) (Kari et al., 1992; NTP, 1989).Dermal toxicity 14 day range finding dermal toxicity study, F344 rats, 12 open applications on 5 d/w of 240 - 3840 mg/kg bw/application: NOAEL 3840 mg/kg bw (Kari et al., 1992; NTP, 1989). No effects were observed in a 90-day dermal study in rats, but HQ was applied at only 0.5% in a cream formulation (i.e. eq. to 74 mg/kg/day), which limited the use of a NOAEL as point of departure for risk assessment. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b38869d4-3f74-4da0-b100-90f5bcbfe0b5/documents/IUC5-b51aac40-528d-4276-894a-0ea451ebd26e_51a248af-f664-403d-93b3-23046133b11c.html,,,,,, Hydroquinone,123-31-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b38869d4-3f74-4da0-b100-90f5bcbfe0b5/documents/IUC5-b51aac40-528d-4276-894a-0ea451ebd26e_51a248af-f664-403d-93b3-23046133b11c.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"3,840 mg/kg bw/day",,rat Hydroquinone,123-31-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b38869d4-3f74-4da0-b100-90f5bcbfe0b5/documents/IUC5-b51aac40-528d-4276-894a-0ea451ebd26e_51a248af-f664-403d-93b3-23046133b11c.html,Chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat Hydroquinone,123-31-9,"Acute toxicity, oral: rat female LD50 = 367 mg/kg bw; rat male LD50 > 375 mg/kg bw (Sheppard, 2002; Topping et al., 2007)Acute toxicity, dermal: rabbit male or female LD50 > 2000 mg/kg bw (Sheppard, 2002; Topping et al., 2007) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b38869d4-3f74-4da0-b100-90f5bcbfe0b5/documents/IUC5-a2c00574-99c2-4862-a980-b57d606f5753_51a248af-f664-403d-93b3-23046133b11c.html,,,,,, Hydroquinone,123-31-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b38869d4-3f74-4da0-b100-90f5bcbfe0b5/documents/IUC5-a2c00574-99c2-4862-a980-b57d606f5753_51a248af-f664-403d-93b3-23046133b11c.html,,oral,LD50,367 mg/kg bw,adverse effect observed, "4-hydroxy-2,2,6,6-tetramethylpiperidinoxyl",2226-96-2,The subacute oral toxicity of 4-Hydroxy TEMPO was tested in a standard OECD 407 guideline study. Liver and spleen were identified as the target organs. The NOAEL was set to 40 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d2d10df-0022-4b89-a16a-3ef220f38c06/documents/IUC5-32a7d0e8-4142-4604-8903-35383e5d870c_467c60b7-f33b-4a9c-9305-48a55a353289.html,,,,,, "4-hydroxy-2,2,6,6-tetramethylpiperidinoxyl",2226-96-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d2d10df-0022-4b89-a16a-3ef220f38c06/documents/IUC5-32a7d0e8-4142-4604-8903-35383e5d870c_467c60b7-f33b-4a9c-9305-48a55a353289.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat "4-hydroxy-2,2,6,6-tetramethylpiperidinoxyl",2226-96-2,"The acute oral LD50 toxicity of 4-Hydroxy-TEMPO was tested in a standard OECD 401 guideline study. Classification: H302, Harmful if swallowed. An LD50 of 1053 mg/kg bw was determined. The acute dermal LD50 toxicity of 4-Hydroxy-TEMPO was tested in a standard OECD 402 guideline study. A limit test with rats at 2000 mg/kg bw dose was performed. A LD50 of >2000 mg/kg was determined. Thus, no classification in regard of dermal toxicity is necessary. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d2d10df-0022-4b89-a16a-3ef220f38c06/documents/IUC5-7ed1e737-466c-4165-aad9-cd6dbd1933d4_467c60b7-f33b-4a9c-9305-48a55a353289.html,,,,,, "4-hydroxy-2,2,6,6-tetramethylpiperidinoxyl",2226-96-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d2d10df-0022-4b89-a16a-3ef220f38c06/documents/IUC5-7ed1e737-466c-4165-aad9-cd6dbd1933d4_467c60b7-f33b-4a9c-9305-48a55a353289.html,,oral,LD50,"1,053 mg/kg bw",adverse effect observed, "4-hydroxy-2,2,6,6-tetramethylpiperidinoxyl",2226-96-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d2d10df-0022-4b89-a16a-3ef220f38c06/documents/IUC5-7ed1e737-466c-4165-aad9-cd6dbd1933d4_467c60b7-f33b-4a9c-9305-48a55a353289.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-hydroxybenzaldehyde,123-08-0, Acute oral toxicity The LD50 value of the test item after oral administration was determined to be 3980 mg/kg bw (reference 7.2.1 -1). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c49849dd-036b-4f09-b165-ef9fcd85b637/documents/b15c2621-97de-4d2a-96aa-7ebaa2483455_6cbbaeb1-3b3a-4235-a39d-b01489b493ae.html,,,,,, 4-hydroxybenzaldehyde,123-08-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c49849dd-036b-4f09-b165-ef9fcd85b637/documents/b15c2621-97de-4d2a-96aa-7ebaa2483455_6cbbaeb1-3b3a-4235-a39d-b01489b493ae.html,,oral,LD50,"3,980 mg/kg bw",no adverse effect observed, "3,4-dihydro-2H-1,4-benzoxazin-6-ol",26021-57-8," In a 90 day study, clinical signs of toxicity were minimal. The NOAEL for general toxicity in the 28-day repeat-dose study in rats was considered to be 10 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c5814c08-fbec-458a-9a4a-20a198204b9b/documents/9606694c-0bd8-4105-b1bb-f93eace8443b_51fd352f-6391-4331-b631-998f12b30cef.html,,,,,, "3,4-dihydro-2H-1,4-benzoxazin-6-ol",26021-57-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c5814c08-fbec-458a-9a4a-20a198204b9b/documents/9606694c-0bd8-4105-b1bb-f93eace8443b_51fd352f-6391-4331-b631-998f12b30cef.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "3,4-dihydro-2H-1,4-benzoxazin-6-ol",26021-57-8,"Hydroxybenzomorpholine has a low order of acute oral toxicity. Based on the available key study ((Lheritier, OECD TG 401, GLP, 1989, Klimisch 1), the acute oral LD50 value of the test item Hydroxybenzomorpholine was found to be between 1000 and 2000 mg/kg bw in male and female rats. No experimental inhalation or dermal acute toxicity studies are available for Hydroxybenzomorpholine. Acute inhalation toxicity study was waived because exposure of humans via inhalation is unlikely taking into account the relatively high melting temperature (113.2 °C), the low vapour pressure (1.66 x 10 -3 Pa at 20°C) and with the relatively high average median particle size (143μm). Acute dermal toxicity could be extrapolated from acute oral toxicity study considernig the in vitro dermal absorption with the low dermal absorption of 2.2%. The LD50 demal for Hydroxybenzomorpholine could be calculated to be between 22 727 mg/kg bw/d and 45 440 mg/kg bw/d. Hence, hydroxybenzomorpholine is not expected to be acutely hazardous via the dermal route. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliability 1 study (Guideline and GLP compliant study). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5814c08-fbec-458a-9a4a-20a198204b9b/documents/30d6d6a8-219c-49f4-956f-534f915f8432_51fd352f-6391-4331-b631-998f12b30cef.html,,,,,, "3,4-dihydro-2H-1,4-benzoxazin-6-ol",26021-57-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5814c08-fbec-458a-9a4a-20a198204b9b/documents/30d6d6a8-219c-49f4-956f-534f915f8432_51fd352f-6391-4331-b631-998f12b30cef.html,,oral,LD50,"> 1,000 mg/kg bw",adverse effect observed, 7-hydroxycitronellal,107-75-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ea09f0f-ef13-4665-be77-22310f4074ef/documents/IUC5-504fc7a0-93e7-4ceb-9566-a11677bb96cf_14f55b6f-a70e-4ec3-b3cf-1d7ba62c425a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,492 mg/kg bw/day,,rat 7-hydroxycitronellal,107-75-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ea09f0f-ef13-4665-be77-22310f4074ef/documents/IUC5-504fc7a0-93e7-4ceb-9566-a11677bb96cf_14f55b6f-a70e-4ec3-b3cf-1d7ba62c425a.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,70 mg/m3,,rat 7-hydroxycitronellal,107-75-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ea09f0f-ef13-4665-be77-22310f4074ef/documents/IUC5-504fc7a0-93e7-4ceb-9566-a11677bb96cf_14f55b6f-a70e-4ec3-b3cf-1d7ba62c425a.html,Repeated dose toxicity – local effects,inhalation,NOAEC,70 mg/m3,no adverse effect observed,rat 7-hydroxycitronellal,107-75-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ea09f0f-ef13-4665-be77-22310f4074ef/documents/IUC5-b71a04d0-eefd-4a07-9d10-858f67ef247c_14f55b6f-a70e-4ec3-b3cf-1d7ba62c425a.html,,oral,LD50,"6,800 mg/kg bw",no adverse effect observed, 7-hydroxycitronellal,107-75-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ea09f0f-ef13-4665-be77-22310f4074ef/documents/IUC5-b71a04d0-eefd-4a07-9d10-858f67ef247c_14f55b6f-a70e-4ec3-b3cf-1d7ba62c425a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,7-dimethyloctane-1,7-diol",107-74-4," The aim of the study was to obtain information on the toxicity of Hydroxycitronellol in rats when given by oral administration via gavage daily for 28 days. The rats were treated with 100, 300 or 1000 mg Hydroxycitronellol/kg b.w./day. The control animals received the vehicle (Labrasol). No deaths occurred during the course of the study. All animals survived until scheduled necropsy. No test item-related changes were observed in behaviour or external appearance, during detailed clinical observations or for any of the parameter of the neurological screening, the body weight, body weight gain and body weight at autopsy, the food and drinking water consumption, the haematological, coagulation and clinical chemistry parameters, the eyes or optic region, the auditory acuity, the relative and absolute organ weights and at macroscopic inspection at necropsy and at histopathological examination at any of the tested dose levels. The faeces of all animals were of a normal consistency throughout the study. In conclusion, under the present test conditions of this study, the NOAEL (No-Observed-Adverse-Effect-Level) is above 1000 mg Hydroxycitronellol/kg b.w./day when given by oral administration as a Labrasol formulation via gavage daily for 28 days. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cba90a26-61d1-4848-9a84-e54ad0d6a425/documents/4d624517-b4c8-4ec9-8d32-17442c01720b_726843d1-2045-41da-8713-f77932740705.html,,,,,, "3,7-dimethyloctane-1,7-diol",107-74-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cba90a26-61d1-4848-9a84-e54ad0d6a425/documents/4d624517-b4c8-4ec9-8d32-17442c01720b_726843d1-2045-41da-8713-f77932740705.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,7-dimethyloctane-1,7-diol",107-74-4," The single oral dosing of rats with 5 mL/kg of the test item caused no mortality or any visible toxic effects. As this dose level did not produce a toxic effect, a complete LD50 study was not performed. The single dermal dosing of rabbits with 5 mL/kg bw of the test item caused no mortality or any visible toxic effects, except of mild erythema. As this dose level did not produce a toxic effect, a complete LD50 study was not performed. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cba90a26-61d1-4848-9a84-e54ad0d6a425/documents/882e065f-d65c-4dc8-b225-4d24affce8a3_726843d1-2045-41da-8713-f77932740705.html,,,,,, Hydroxycyclohexyl phenyl ketone,947-19-3, Study carried out according to guideline and with GLP compliance. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0fbe88e5-76c3-4a01-b5e9-07baae9efdd4/documents/IUC5-865835c0-1023-4845-ad1a-59833cb0dc03_80368f88-4e2d-4ebb-85a0-297548ef27f6.html,,,,,, Hydroxycyclohexyl phenyl ketone,947-19-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0fbe88e5-76c3-4a01-b5e9-07baae9efdd4/documents/IUC5-865835c0-1023-4845-ad1a-59833cb0dc03_80368f88-4e2d-4ebb-85a0-297548ef27f6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Hydroxycyclohexyl phenyl ketone,947-19-3,All studies were performed using methodologies comparable to recognised testing guidelines. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fbe88e5-76c3-4a01-b5e9-07baae9efdd4/documents/IUC5-153c97f4-b994-43b8-8281-c3abf08a486b_80368f88-4e2d-4ebb-85a0-297548ef27f6.html,,,,,, Hydroxycyclohexyl phenyl ketone,947-19-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fbe88e5-76c3-4a01-b5e9-07baae9efdd4/documents/IUC5-153c97f4-b994-43b8-8281-c3abf08a486b_80368f88-4e2d-4ebb-85a0-297548ef27f6.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Hydroxycyclohexyl phenyl ketone,947-19-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fbe88e5-76c3-4a01-b5e9-07baae9efdd4/documents/IUC5-153c97f4-b994-43b8-8281-c3abf08a486b_80368f88-4e2d-4ebb-85a0-297548ef27f6.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Hydroxycyclohexyl phenyl ketone,947-19-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fbe88e5-76c3-4a01-b5e9-07baae9efdd4/documents/IUC5-153c97f4-b994-43b8-8281-c3abf08a486b_80368f88-4e2d-4ebb-85a0-297548ef27f6.html,,inhalation,LC50,"1,000 mg/m3",no adverse effect observed, Hexadecyl(2-hydroxyethyl)dimethylammonium dihydrogen phosphate,85563-48-0,AOT (OECD 401): LD50 => 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c625e6cb-b7a1-4987-a8b0-7bdc32253fec/documents/IUC5-edc66b49-f262-4f46-b990-5b0fdaf052dc_7ed021ed-f9cd-4f2c-aa70-c089295ffd70.html,,,,,, Hexadecyl(2-hydroxyethyl)dimethylammonium dihydrogen phosphate,85563-48-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c625e6cb-b7a1-4987-a8b0-7bdc32253fec/documents/IUC5-edc66b49-f262-4f46-b990-5b0fdaf052dc_7ed021ed-f9cd-4f2c-aa70-c089295ffd70.html,,oral,LD50,"2,029 mg/kg bw",no adverse effect observed, 1-(2-hydroxyethyl)imidazolidin-2-one,3699-54-5,"In a subacute oral (gavage) repeated dose toxicity study (28 days) in rats a NOAEL of 1000 mg/kg bw/day for males and females was observed. In a combined repeated gavage dose toxicity study with the reproduction/developmental toxicity screening test in rats a NOAEL of 1000 mg/kg bw/day for parental males and females was observed.In both studies, no adverse effects were observed at the dose levels tested. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5bf539a-aadb-4925-b95b-23084714a144/documents/IUC5-f0a3b3f1-3ac6-4e10-89c4-6d65b4594a7f_f3266999-6a13-4ae0-a005-f799268c8d22.html,,,,,, 1-(2-hydroxyethyl)imidazolidin-2-one,3699-54-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5bf539a-aadb-4925-b95b-23084714a144/documents/IUC5-f0a3b3f1-3ac6-4e10-89c4-6d65b4594a7f_f3266999-6a13-4ae0-a005-f799268c8d22.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, 1-(2-hydroxyethyl)imidazolidin-2-one,3699-54-5,A LD50 value of >5000 mg/kg bw was observed for rats after acute oral and dermal exposure. There are no data available concerning acute inhalation toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5bf539a-aadb-4925-b95b-23084714a144/documents/IUC5-92d8139c-8734-4acf-a1dc-a7fb4fa608af_f3266999-6a13-4ae0-a005-f799268c8d22.html,,,,,, 2-(N-methyl-p-toluidino)ethanol,2842-44-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0530ccc-018e-412c-ace1-2cf93e62cec3/documents/b511b5b1-39fb-4cf7-86a4-243691ce1c32_9a6755c5-0d8a-4f2f-94c7-6727a943ed6a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, (hydroxyethyl)urea,1320-51-0,"The only repeat dose study available is a 90 day dermal study using a 57.58% solution of hydroxyethyl urea in water (EXP3982).  As dermal exposure is the most likely route of exposure, with very little possibility of inhalation or oral exposure, this study will be used as the basis for calculation DNELs.  Additional testing by the oral and inhalation routes is not considered to be scientifically justified. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7640d96-b351-4a42-81ca-958aa1f3d7dd/documents/IUC5-e2bcd5f9-811f-44ab-bf7c-569d0c82caee_bf85ef37-5166-4d5c-8e28-7c525b8f0dcd.html,,,,,, (hydroxyethyl)urea,1320-51-0,"There are Klimisch 1 studies available on the Hydroxyethyl urea for acute oral, dermal and inhalation toxicity.  The oral and dermal studies showed LD50 values in excess of the 2000 mg/kg bodyweight limit dose.  The inhalation study did not reach the 20mg/l limit dose but at the maximum achievable dose of 4mg/l it showed no systemic toxic effect. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7640d96-b351-4a42-81ca-958aa1f3d7dd/documents/IUC5-f32d11f2-1563-418c-b571-f25418cb8574_bf85ef37-5166-4d5c-8e28-7c525b8f0dcd.html,,,,,, 2-((4-methyl-2-nitrophenyl)amino)ethanol,100418-33-5, Guidelined sub-acute and sub-chronic oral studies in rats ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/953b7f21-85d7-4e87-bfa8-915d6a7ca22c/documents/d6a2e7c4-601e-4b13-b9e8-b0c5167efd09_5b23686c-ca01-4f72-bb32-0f18b3a0eab1.html,,,,,, 2-((4-methyl-2-nitrophenyl)amino)ethanol,100418-33-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/953b7f21-85d7-4e87-bfa8-915d6a7ca22c/documents/d6a2e7c4-601e-4b13-b9e8-b0c5167efd09_5b23686c-ca01-4f72-bb32-0f18b3a0eab1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,90 mg/kg bw/day,,rat 2-((4-methyl-2-nitrophenyl)amino)ethanol,100418-33-5, Guidelined oral and dermal study in rats. Under the experimental conditions employed the LD50 was calculated to be 1564 mg/kg bw and 1436 mg/kg bw in male and female rats respectively. The substance 2-((4-methyl-2-nitrophenyl)amino)ethanol was classified as acute toxicity (oral) category 4. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/953b7f21-85d7-4e87-bfa8-915d6a7ca22c/documents/96d9f6a2-da51-46a8-8034-ec1b4dfe6fa5_5b23686c-ca01-4f72-bb32-0f18b3a0eab1.html,,,,,, 2-((4-methyl-2-nitrophenyl)amino)ethanol,100418-33-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/953b7f21-85d7-4e87-bfa8-915d6a7ca22c/documents/96d9f6a2-da51-46a8-8034-ec1b4dfe6fa5_5b23686c-ca01-4f72-bb32-0f18b3a0eab1.html,,oral,LD50,"1,436 mg/kg bw",adverse effect observed, 2-((4-methyl-2-nitrophenyl)amino)ethanol,100418-33-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/953b7f21-85d7-4e87-bfa8-915d6a7ca22c/documents/96d9f6a2-da51-46a8-8034-ec1b4dfe6fa5_5b23686c-ca01-4f72-bb32-0f18b3a0eab1.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-(1,3-benzodioxol-5-ylamino)ethanol hydrochloride",94158-14-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d48374d-fa05-415e-97f7-ef6e0b28984d/documents/68fd31fe-30ff-46fe-b232-de523969b3ad_d0b84778-ea07-4515-95d8-234ef0fd9243.html,,oral,LD50,850 mg/kg bw,no adverse effect observed, "2-(1,3-benzodioxol-5-ylamino)ethanol hydrochloride",94158-14-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d48374d-fa05-415e-97f7-ef6e0b28984d/documents/68fd31fe-30ff-46fe-b232-de523969b3ad_d0b84778-ea07-4515-95d8-234ef0fd9243.html,,dermal,LD50,"1,865 mg/kg bw",no adverse effect observed, 3-(2-hydroxyethyl)-p-phenylenediammonium sulphate,93841-25-9," In a 90 day repeated dose study performed according to OECD 408, hydroxyethyl-p-phenylenediamine sulfate induced an increase in the aspartate aminotransferase and alanine aminotransferase activities in CRL:(WI) BR rats at a dose of 55 mg/kg bw/day. The NOAEL in the study was 35 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fad452d-4b67-45a0-8ee4-f3620602c91a/documents/4589c89f-28c3-4ea5-8ffa-f4d898bf6c69_7ea21bcb-54ac-4ba8-b78c-3d89b438bb68.html,,,,,, 3-(2-hydroxyethyl)-p-phenylenediammonium sulphate,93841-25-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fad452d-4b67-45a0-8ee4-f3620602c91a/documents/4589c89f-28c3-4ea5-8ffa-f4d898bf6c69_7ea21bcb-54ac-4ba8-b78c-3d89b438bb68.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,35 mg/kg bw/day,,rat 3-(2-hydroxyethyl)-p-phenylenediammonium sulphate,93841-25-9, LD50 values of 80 -150 mg/kg bw were obtained from acute oral toxicity studies performed in rats. Classification as acute toxicity category 3 is applicable according to the CLP criteria along with hazard statement H301 : toxic if swallowed. The determination of acute inhalation and acute dermal toxicity was performed by calculation using the available acute oral toxicity and kinetic data. Classification as acute toxicity category 4 is applicable according to the CLP criteria along with hazard statement H332 : harmful if inhaled. The substance is not classified regarding acute dermal toxicity according to the CLP criteria. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fad452d-4b67-45a0-8ee4-f3620602c91a/documents/IUC5-ecc950a9-8bea-46e9-bc11-2a8a8068ca0f_7ea21bcb-54ac-4ba8-b78c-3d89b438bb68.html,,,,,, 3-(2-hydroxyethyl)-p-phenylenediammonium sulphate,93841-25-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fad452d-4b67-45a0-8ee4-f3620602c91a/documents/IUC5-ecc950a9-8bea-46e9-bc11-2a8a8068ca0f_7ea21bcb-54ac-4ba8-b78c-3d89b438bb68.html,,oral,LD50,80 mg/kg bw,adverse effect observed, 3-(2-hydroxyethyl)-p-phenylenediammonium sulphate,93841-25-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fad452d-4b67-45a0-8ee4-f3620602c91a/documents/IUC5-ecc950a9-8bea-46e9-bc11-2a8a8068ca0f_7ea21bcb-54ac-4ba8-b78c-3d89b438bb68.html,,dermal,LD50,"14,032 mg/kg bw",no adverse effect observed, 3-(2-hydroxyethyl)-p-phenylenediammonium sulphate,93841-25-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fad452d-4b67-45a0-8ee4-f3620602c91a/documents/IUC5-ecc950a9-8bea-46e9-bc11-2a8a8068ca0f_7ea21bcb-54ac-4ba8-b78c-3d89b438bb68.html,,inhalation,LC50,"1,130 mg/m3",adverse effect observed, 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonic acid,7365-45-9," Oral (OECD 407), 28 days, rat: NOAEL (systemic) ≥ 1000 mg/kg bw/day (reference 7.5.1 -1) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6218b81-9b15-4395-913a-a0ddec05b329/documents/f6f7d0b7-faf7-4f93-9702-a6f774ee95fb_44e38bfa-fa5f-4c2f-80d5-7bcc6e65c300.html,,,,,, 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonic acid,7365-45-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6218b81-9b15-4395-913a-a0ddec05b329/documents/f6f7d0b7-faf7-4f93-9702-a6f774ee95fb_44e38bfa-fa5f-4c2f-80d5-7bcc6e65c300.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonic acid,7365-45-9," Oral (OECD TG 423), rat: LD50 > 2000 mg/kg bw (reference 7.2.1 -1) Dermal (OECD TG 402), rat: LD50 > 2000 mg/kg bw (reference 7.2.3 -1). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6218b81-9b15-4395-913a-a0ddec05b329/documents/fa83d112-e4f4-45a7-ad75-83491e640d77_44e38bfa-fa5f-4c2f-80d5-7bcc6e65c300.html,,,,,, 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonic acid,7365-45-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6218b81-9b15-4395-913a-a0ddec05b329/documents/fa83d112-e4f4-45a7-ad75-83491e640d77_44e38bfa-fa5f-4c2f-80d5-7bcc6e65c300.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonic acid,7365-45-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6218b81-9b15-4395-913a-a0ddec05b329/documents/fa83d112-e4f4-45a7-ad75-83491e640d77_44e38bfa-fa5f-4c2f-80d5-7bcc6e65c300.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Hydroxylammonium chloride,5470-11-1," NOAEL (28 days, rat): 7.77 mg/kg bw/d RA from source substance bis(hydroxyammonium) sulfate (CAS 10039-54-0) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4fd8b2b-7b8d-455b-88cc-7f3de911ee26/documents/e880de46-8c40-455c-9b6e-c2f19b2981cc_8b285550-5519-4d2a-b36f-ff8c672976ac.html,,,,,, Hydroxylammonium chloride,5470-11-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4fd8b2b-7b8d-455b-88cc-7f3de911ee26/documents/e880de46-8c40-455c-9b6e-c2f19b2981cc_8b285550-5519-4d2a-b36f-ff8c672976ac.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,7.77 mg/kg bw/day,,rat Hydroxylammonium chloride,5470-11-1," Acute toxicity, oral (similar to OECD 401, RL2), male and female rats: LD50 = 642 mg/kg bw RA from source substance bis(hydroxyammonium) sulfate (CAS 10039-54-0) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4fd8b2b-7b8d-455b-88cc-7f3de911ee26/documents/c4663cb4-8571-4ee4-8d27-4e718975cd33_8b285550-5519-4d2a-b36f-ff8c672976ac.html,,,,,, Hydroxylammonium chloride,5470-11-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4fd8b2b-7b8d-455b-88cc-7f3de911ee26/documents/c4663cb4-8571-4ee4-8d27-4e718975cd33_8b285550-5519-4d2a-b36f-ff8c672976ac.html,,oral,LD50,642 mg/kg bw,adverse effect observed, Bis(hydroxylammonium) sulphate,10039-54-0,"CAS No. 10039-54-0:oral- 90 d, rat, oral: NOAEL = > 0.9 mg/kg bw/d (nominal) for males and females- 28 d, rat, oral: NOAEL = 25 ppm for males and 100 ppm for females- 12 months, rat, oral: NOAEL = 0.2/0.3 mg/kg bw/d in males and 0.4 mg/kg bw/d in females for systemic effects ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/482fa259-95c3-4f2c-80c3-7844e8a030aa/documents/IUC5-85eb8c43-3760-46c6-814f-ae4c22dcc6e5_c8a892f4-b5ae-4f15-a571-848bfe593eec.html,,,,,, Bis(hydroxylammonium) sulphate,10039-54-0, Acute toxicity oral: Rat: LD50 = 642 mg/kg bw Cat: LD50 > 50 and < 200 mg/kg bw (females) and > 200 mg/kg bw (males) Dermal Rat: LD50 > 500 mg/kg bw Acute toxicity inhalation: no mortality was observed in IHT. Acute toxicity dermal: Rabbit: LD50 > 1000 mg/kg bw (semiocclusive test conditions) Rabbit: LD50 > 100 and < 500 mg/kg bw (occlusive test conditions) Rabbit: LD50 > 400 mg/kg bw Rabbit: LD50 > 1500 and < 2000 mg/kg bw (semiocclusive test conditions) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/482fa259-95c3-4f2c-80c3-7844e8a030aa/documents/4ebc1e04-b811-47c1-87b7-7da47d65674a_c8a892f4-b5ae-4f15-a571-848bfe593eec.html,,,,,, 1-hydroxyoctan-2-one,7019-19-4," A combination of in silico QSAR and a single read-across study (for octan-2 -one) have been used in a WoE approach to determine the acute oral toxicity of 1 -hydroxyoctan-2 -one. Interpretation of QSAR Results REACHAcross™v3.1.4 estimates an 82% probability that 1 -hydroxyoctan-2 -one (SMILES: O=C(CO)CCCCCC) is not an acute oral hazard. Interpretation of read-across results for structural analogue In a acute oral toxicity study summarised in a peer reviewed literature paper from 1975, rats were treated with octan-2-one in the concentration of 5000 mg/kg orally. No mortality was observed in treated rats at 5000 mg/kg bw. Therefore, LD50 was considered to be >5000 mg/kg when rats were treated with methyl hexyl ketone orally. Conclusion Based on the considerations above, it can be confidently concluded that read-across and QSAR arguments can be used in a weight of evidence approach, to satisfy the acute oral toxicity endpoint for EXPINN PC17032 (1-hydroxyoctan-2-one) and it is appropriate and scientifically justified.   The substance is not expected to pose an acute toxic hazard via the oral route and a result of LD50 >2000 mg/kg will be used for regulatory notification and product safety/risk assessment purposes. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfec1d3b-f23e-4ea2-9d31-ddfb6ca2f88c/documents/5714e62e-99c8-4631-b49a-743c9f581103_c5bd25a8-0bcd-4961-b962-0ff623db15e0.html,,,,,, 1-hydroxyoctan-2-one,7019-19-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfec1d3b-f23e-4ea2-9d31-ddfb6ca2f88c/documents/5714e62e-99c8-4631-b49a-743c9f581103_c5bd25a8-0bcd-4961-b962-0ff623db15e0.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, L-4-hydroxyproline,51-35-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): K1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0a91755-b168-4607-8c6f-3b9036c72792/documents/167c4e80-bc94-4d9a-8061-f5b8d24d116e_12691618-5698-4750-9fa4-853d4488e70c.html,,,,,, L-4-hydroxyproline,51-35-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0a91755-b168-4607-8c6f-3b9036c72792/documents/167c4e80-bc94-4d9a-8061-f5b8d24d116e_12691618-5698-4750-9fa4-853d4488e70c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat L-4-hydroxyproline,51-35-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): K2 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0a91755-b168-4607-8c6f-3b9036c72792/documents/7dd61f38-5f33-4778-b075-2b6d03ea2544_12691618-5698-4750-9fa4-853d4488e70c.html,,,,,, L-4-hydroxyproline,51-35-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0a91755-b168-4607-8c6f-3b9036c72792/documents/7dd61f38-5f33-4778-b075-2b6d03ea2544_12691618-5698-4750-9fa4-853d4488e70c.html,,oral,LD50,"16,000 mg/kg bw",no adverse effect observed, 2-Hydroxypropyl-β-cyclodextrine ethers,128446-35-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91d44d30-2dc3-438c-bbe7-50aaa806f5e7/documents/5935c3b2-912e-4588-8292-9561d1ea3b8e_18ed0e5e-22d4-4069-97d9-f2ba641dc8e9.html,Repeated dose toxicity – local effects,inhalation,LOAEC,100 mg/m3,adverse effect observed,rat "Methacrylic acid, monoester with propane-1,2-diol",27813-02-1," Repeated dose toxicity of HPMA has been investigated in an OECD 422 combined repeated dose and reproductive toxicity study. A chronic study does not have to be performed, because, like MMA, the substances are rapidly metabolised, and by analogy to MMA ultimately metabolised to carbon dioxide and water. Therefore, as demonstrated in the case of MMA in carcinogenicity studies of up to 2 years duration, there is no concern for lesions due to accumulative toxicity. MMA data with different species and different application routes are used by read-across. For PG, the glycolic metabolite of HPMA, long term feeding studies up to 2 years in rodent and non-rodent species are available. Renal effects were observed only in high dosages.   Read across evaluation according to ECHA’s ReadAcrossAssessment Framework (RAAF) The metabolism from the HPMA to its primary metabolites is well understood. The same is true for the further metabolism pathways of MAA and the alcohol metabolite PG, respectively (see chapter 5.2, ATSDR 1997/ 2008/ 2010, NTP 2004a, 2004b). The endpoint specific “scientific assessment” of the read across is thus “acceptable with a high level of confidence”, see the attached Read Across Justification (2022) and Category document (2019).   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4111f8ba-48f5-46de-90fd-15bfc3c06ccd/documents/IUC5-bd783d76-5c74-4e0a-8f05-35148e1c187b_70c9817a-83ac-49c0-ae1e-e0de2c6493c2.html,,,,,, "Methacrylic acid, monoester with propane-1,2-diol",27813-02-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4111f8ba-48f5-46de-90fd-15bfc3c06ccd/documents/IUC5-bd783d76-5c74-4e0a-8f05-35148e1c187b_70c9817a-83ac-49c0-ae1e-e0de2c6493c2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Methacrylic acid, monoester with propane-1,2-diol",27813-02-1," Acute oral toxicity: LD50 > 5000 mg/kgAcute dermal toxicity: LD50 > 5000 mg/kgAcute inhalation toxicity: no data available, no toxicity is expected 2-Hydroxypropyl methacrylate is of low acute oral toxicity.  [MHLW, 1996: LD50 > 2000 mg/kg, Rohm & Haas, 1982: > 5000 mg/kg, Rohm & Haas, 1961: > 5000 mg/kg). Hydroxypropyl methacrylate is of low dermal toxicity (LD50: > 5000 mg/kg) (Rohm & Haas, 1982). Due to the low vapour pressure of HPMA, inhalation is not an expected route of exposure.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): One OECD 401 Guideline study is available which has been performend under GLP at concentrations up to 2000 mg/kg with original documentation in Japanese and an abstract in English (MHLW 1996). Supporting information is available with two non GLP studies at > 5000 mg/kg of Rohm & Haas and sufficient documentation. (Rohm & Haas 1982 and 1961, respectively). Additional test data are available in rats and mice where animals. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The key study is of limeted documentation. Additional handbook data support the key study. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4111f8ba-48f5-46de-90fd-15bfc3c06ccd/documents/IUC5-4356188e-ddf1-40ea-ba98-40e35a07910e_70c9817a-83ac-49c0-ae1e-e0de2c6493c2.html,,,,,, "Methacrylic acid, monoester with propane-1,2-diol",27813-02-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4111f8ba-48f5-46de-90fd-15bfc3c06ccd/documents/IUC5-4356188e-ddf1-40ea-ba98-40e35a07910e_70c9817a-83ac-49c0-ae1e-e0de2c6493c2.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Methacrylic acid, monoester with propane-1,2-diol",27813-02-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4111f8ba-48f5-46de-90fd-15bfc3c06ccd/documents/IUC5-4356188e-ddf1-40ea-ba98-40e35a07910e_70c9817a-83ac-49c0-ae1e-e0de2c6493c2.html,,dermal,LD50,">=5,000 mg/kg bw",no adverse effect observed, "4-hydroxymethyl-1,3-dioxolan-2-one",931-40-8," Two key studies have been identified: one 90d oral toxicity study (K2, The Dow Chemical Company, 1962) and one subchronic toxicity by inhalation study (K2, Renne R., 1992), both performed with the read-across substance glycerol. Repeated dose toxicity: oral: The effect of glycerol following administration for 90 days in a subchronic toxicity study was examined (The Dow Chemical Company, 1962). The test has been performed with the read-across substance glycerol. Animals were exposed orally (via diet) to 0, 5 and 20 % of test substance in diet. A NOAEL of 4850 mg/kg  was determined. This study was scored as K2 study (reliable with restrictions) because of read across purposes and was considered as the key study. Repeated dose toxicity: inhalation: The subchronic toxicity of glycerol was examined following aerosol exposure. Sprague-Dawley rats were exposed to 33, 165 and 660 mg/m³ (nominal concentration) of test item, during 6 hours/day, 5days a week for 13 weeks. The NOAEL was determined to be 167 mg/m³ (actual dose level) based on local irritant effects on the upper respiratory tract. Repeated dose toxicity: dermal: Key studies are available for the oral and inhalation routes of exposure (read across with glycerol). According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55e345dc-372b-4cff-8a15-d4687a5f05bd/documents/IUC5-a7c3c4f2-f2de-4d7d-bc51-91417597fcb0_65ef0e5f-0520-4d5f-a3c2-232910b9962e.html,,,,,, "4-hydroxymethyl-1,3-dioxolan-2-one",931-40-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55e345dc-372b-4cff-8a15-d4687a5f05bd/documents/IUC5-a7c3c4f2-f2de-4d7d-bc51-91417597fcb0_65ef0e5f-0520-4d5f-a3c2-232910b9962e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"4,580 mg/kg bw/day",,rat "4-hydroxymethyl-1,3-dioxolan-2-one",931-40-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55e345dc-372b-4cff-8a15-d4687a5f05bd/documents/IUC5-a7c3c4f2-f2de-4d7d-bc51-91417597fcb0_65ef0e5f-0520-4d5f-a3c2-232910b9962e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,167 mg/m3,adverse effect observed,rat "4-hydroxymethyl-1,3-dioxolan-2-one",931-40-8,"Acute toxicity: oral:A K2 acute oral toxicity test was performed in male and female Sprague Dawley rats according to a guideline similar to OECD Guideline 401 (Mallory VT, 1993). Acute toxicity: inhalationA K1 acute inhalation toxicity test was performed in male and female Sprague Dawley rats according to OECD Guideline 403 and US EPA OPPTS Guideline 870.1300 (Weinberg, 2014). Acute toxicity: dermalA K2 acute dermal toxicity test was performed in male and female New Zealand White rabbits according to a guideline similar to OECD Guideline 402 (Mallory VT, 1993). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55e345dc-372b-4cff-8a15-d4687a5f05bd/documents/IUC5-252feb26-55d3-409c-8d22-4d1c3ca02ed0_65ef0e5f-0520-4d5f-a3c2-232910b9962e.html,,,,,, 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide,106-15-0," Repeated dose toxicity: Oral The no observed adverse effect level (NOAEL) for the test chemical is considered to be 1000 mg/Kg bw/day using rats as the animal model. Repeated dose toxicity: Inhalation 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide (106-15-0) has very low vapour pressure (< 0.133 Pa). So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated inhalation toxicity was considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value for 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not irritating and not sensitizing to the skin. Based on these considerations, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e97d0b90-bb1f-4a87-baf6-e8ed6db90788/documents/780eff30-bf11-466b-ab3a-baf5b935badb_a0f76b0b-005f-49c8-9734-68e1abd68bf7.html,,,,,, 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide,106-15-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e97d0b90-bb1f-4a87-baf6-e8ed6db90788/documents/780eff30-bf11-466b-ab3a-baf5b935badb_a0f76b0b-005f-49c8-9734-68e1abd68bf7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide,106-15-0," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is 6500 mg/kg bw. The value concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to low vapour pressure of the test chemical, which is reported to be < 0.133 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the given test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e97d0b90-bb1f-4a87-baf6-e8ed6db90788/documents/fdda97aa-8a8e-421c-895c-c5d38e3b0e5e_a0f76b0b-005f-49c8-9734-68e1abd68bf7.html,,,,,, 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide,106-15-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e97d0b90-bb1f-4a87-baf6-e8ed6db90788/documents/fdda97aa-8a8e-421c-895c-c5d38e3b0e5e_a0f76b0b-005f-49c8-9734-68e1abd68bf7.html,,oral,LD50,"6,500 mg/kg bw",no adverse effect observed, 12-hydroxy-N-(2-hydroxyethyl)octadecan-1-amide,106-15-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e97d0b90-bb1f-4a87-baf6-e8ed6db90788/documents/fdda97aa-8a8e-421c-895c-c5d38e3b0e5e_a0f76b0b-005f-49c8-9734-68e1abd68bf7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 12-hydroxystearic acid,106-14-9,"Taking into account the properties of the substance, the oral route was identified as the most relevant route of exposure. A study conducted in accordance with the OECD Testing Guideline 422 is available on the registered substance. The NOAEL for systemic toxicity was concluded to be 1000 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24762af5-9b10-4635-9a31-d49494ff2bc5/documents/IUC5-136791d2-10ff-410c-82b2-7d0823d71a8b_03ae0f8f-a2de-4e3c-9ea4-485e6bcade3b.html,,,,,, 12-hydroxystearic acid,106-14-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24762af5-9b10-4635-9a31-d49494ff2bc5/documents/IUC5-136791d2-10ff-410c-82b2-7d0823d71a8b_03ae0f8f-a2de-4e3c-9ea4-485e6bcade3b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 12-hydroxystearic acid,106-14-9,"No mortality was observed following a single exposure to 2000 mg/kg bw of the registered substance via the oral route.   A study investigating the acute toxicity of the registered substance via inhalation does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and the possibility of exposure to aerosols, particles or droplets of an inhalable size.   A study investigating the acute toxicity of the registered substance via the dermal route does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (skin sensitisation). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24762af5-9b10-4635-9a31-d49494ff2bc5/documents/005a0950-d4fa-4a4c-94d3-02f497441ee6_03ae0f8f-a2de-4e3c-9ea4-485e6bcade3b.html,,,,,, 12-hydroxystearic acid,106-14-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24762af5-9b10-4635-9a31-d49494ff2bc5/documents/005a0950-d4fa-4a4c-94d3-02f497441ee6_03ae0f8f-a2de-4e3c-9ea4-485e6bcade3b.html,,oral,LD0,"2,000 mg/kg bw",no adverse effect observed, "Octadecane-1,12-diol",2726-73-0,A combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422 and GLP compliant) was performed and the NOAEL for repeated dose toxicity was found to be greater than 1000 mg/kg bw/day (highest dose tested). ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb8584b7-7474-4b23-a014-29a3bee54115/documents/IUC5-dfb6bd4b-1556-4b23-965a-7c27aacee1d7_9439b133-014d-4c47-93cc-ae8f242cf913.html,,,,,, "Octadecane-1,12-diol",2726-73-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb8584b7-7474-4b23-a014-29a3bee54115/documents/IUC5-dfb6bd4b-1556-4b23-965a-7c27aacee1d7_9439b133-014d-4c47-93cc-ae8f242cf913.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Octadecane-1,12-diol",2726-73-0,"Acute toxicity data indicate no acute toxicity. In rats the oral LD50 was >5000 mg/kg bw (similar to OECD 401). Dermal exposure in rats resulted in a LD50>2000 mg/kg/bw (OECD 402, GLP compliant). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb8584b7-7474-4b23-a014-29a3bee54115/documents/IUC5-b607ca92-68b1-4367-8813-b29263757bef_9439b133-014d-4c47-93cc-ae8f242cf913.html,,,,,, "Octadecane-1,12-diol",2726-73-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb8584b7-7474-4b23-a014-29a3bee54115/documents/IUC5-b607ca92-68b1-4367-8813-b29263757bef_9439b133-014d-4c47-93cc-ae8f242cf913.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Octadecane-1,12-diol",2726-73-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb8584b7-7474-4b23-a014-29a3bee54115/documents/IUC5-b607ca92-68b1-4367-8813-b29263757bef_9439b133-014d-4c47-93cc-ae8f242cf913.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ibuprofen,15687-27-1," The lowest NOAEL observed in the four repeated dose toxicity studies available is 40 mg/kg bw. In that study, the test substance induced toxic effects in the kidney in monkeys after repeated oral exposure. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3836a83b-a630-4464-8449-12fcf423146e/documents/cb736af1-a2b0-41a0-b9c9-1c37304db3aa_0e87f5c3-9652-4dc4-90dd-144ac8b2b02f.html,,,,,, Ibuprofen,15687-27-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3836a83b-a630-4464-8449-12fcf423146e/documents/cb736af1-a2b0-41a0-b9c9-1c37304db3aa_0e87f5c3-9652-4dc4-90dd-144ac8b2b02f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,monkey Ibuprofen,15687-27-1, The oral LD50 was determined to be 800 - 1600 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3836a83b-a630-4464-8449-12fcf423146e/documents/35bf24f1-6386-469a-849f-0db887fc50c3_0e87f5c3-9652-4dc4-90dd-144ac8b2b02f.html,,,,,, Ibuprofen,15687-27-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3836a83b-a630-4464-8449-12fcf423146e/documents/35bf24f1-6386-469a-849f-0db887fc50c3_0e87f5c3-9652-4dc4-90dd-144ac8b2b02f.html,,oral,LD50,800 mg/kg bw,adverse effect observed, 2-imidazolidone,120-93-4,"Key: NOAEL (male/female) = 100 ppm (8.3 mg/kg bw/d in males and 10.5 mg/kg bw/d in females) based on decreased body weight and histopathological findings in thyroid glands, rat, 90 days (subchronic), oral (drinking water), GLP, OECD 408, 2018, K1   Key: NOAEL = 500 ppm (37 mg/kg bw/day in parental males and 57 mg/kg bw/day in parental females) based on decreased body weight and food consumption and histopathological findings in thyroid glands, rat, 30-51 days (subacute), oral (drinking water), GLP, OECD 422, 2013, K1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d66001a-7465-4a56-aa69-814f5ebd2f08/documents/868229f0-33ed-4cc3-92d3-360e7a47eb66_10af7873-2d48-461b-94b5-5249c97eb458.html,,,,,, 2-imidazolidone,120-93-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d66001a-7465-4a56-aa69-814f5ebd2f08/documents/868229f0-33ed-4cc3-92d3-360e7a47eb66_10af7873-2d48-461b-94b5-5249c97eb458.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,37 mg/kg bw/day,,rat 2-imidazolidone,120-93-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d66001a-7465-4a56-aa69-814f5ebd2f08/documents/868229f0-33ed-4cc3-92d3-360e7a47eb66_10af7873-2d48-461b-94b5-5249c97eb458.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,8.3 mg/kg bw/day,,rat 2-imidazolidone,120-93-4,"Acute oral toxicity Key: LD50 > 5010 mg/kg bw, rat, pre-GLP, similar to OECD 401, 1958, K2   Acute dermal toxicity Key: LD50 > 2000 mg/kg bw, rat, GLP, OECD 402, 2012, K1 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d66001a-7465-4a56-aa69-814f5ebd2f08/documents/681372e0-7694-4fc9-946e-f43efe0920bf_10af7873-2d48-461b-94b5-5249c97eb458.html,,,,,, "N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]",39236-46-9," Subchronic oral NOEL (rat) 280 mg/kg/day based on read-across, supported by a subchronic oral NOAEL for the registered substance 653-672 mg/kg/day, which was considered insufficient for use in assessment. Subacute dermal NOAEL (systemic toxicity, rabbit) 200 mg/kg/day. Subacute LOAEL for localised dermatitis after repeated occlusive application to skin 45 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2eef0c9-415c-4dd7-a15e-78a6f747b613/documents/IUC5-8feb76dd-95d2-4baf-ae73-beb343561ee3_3277dc47-622f-4657-95a5-c5dc9869f53f.html,,,,,, "N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]",39236-46-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2eef0c9-415c-4dd7-a15e-78a6f747b613/documents/IUC5-8feb76dd-95d2-4baf-ae73-beb343561ee3_3277dc47-622f-4657-95a5-c5dc9869f53f.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,200 mg/kg bw/day,,rabbit "N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]",39236-46-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2eef0c9-415c-4dd7-a15e-78a6f747b613/documents/IUC5-8feb76dd-95d2-4baf-ae73-beb343561ee3_3277dc47-622f-4657-95a5-c5dc9869f53f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,280 mg/kg bw/day,,rat "N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]",39236-46-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2eef0c9-415c-4dd7-a15e-78a6f747b613/documents/IUC5-8feb76dd-95d2-4baf-ae73-beb343561ee3_3277dc47-622f-4657-95a5-c5dc9869f53f.html,Repeated dose toxicity – local effects,dermal,LOAEL,45 ,adverse effect observed,rabbit "N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]",39236-46-9, Acute oral LD50 in the rat 5200 mg/kg and dermal toxicity with LD0 of 8000 mg/kg. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2eef0c9-415c-4dd7-a15e-78a6f747b613/documents/IUC5-25164533-41da-414b-a637-87a4deb594cb_3277dc47-622f-4657-95a5-c5dc9869f53f.html,,,,,, "N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]",39236-46-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2eef0c9-415c-4dd7-a15e-78a6f747b613/documents/IUC5-25164533-41da-414b-a637-87a4deb594cb_3277dc47-622f-4657-95a5-c5dc9869f53f.html,,oral,LD50,"5,200 mg/kg bw",adverse effect observed, "N,N''-methylenebis[N'-[3-(hydroxymethyl)-2,5-dioxoimidazolidin-4-yl]urea]",39236-46-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2eef0c9-415c-4dd7-a15e-78a6f747b613/documents/IUC5-25164533-41da-414b-a637-87a4deb594cb_3277dc47-622f-4657-95a5-c5dc9869f53f.html,,dermal,,"8,000 mg/kg bw",no adverse effect observed, "Indigofera tinctoria, ext.",84775-63-3, The acute toxicity of 90% ehanolic extract of Indigofera tinctoria was determined as per the OECD guideline no. 423 (Acute Toxic Class Method). It was observed that the test extract was not mortal even at 2000mg/kg dose. Other studies support this result. The other oral toxicity study informs that LD0 is 4000 -5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bda0455-ec58-45e6-97cd-78df140eecaf/documents/1fc1004b-e5b1-4f20-a9d7-304b3121ad04_eda81fee-34c2-4e75-81c1-d227b23f7ba5.html,,,,,, Indole,120-72-9," This (Kaiser 1953) is just a one dose level examinations (100 mg/kg bw) ( 1 group / 25 animal/ sex) , and it had adverse effect. To determine a NOEL we would need different dose levels. Extrapolation of NOEL or LOEL is not possible from this test, therefore using for REACH has low value, it is just ranked as Klimisch 3 or 4. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34ebfd63-0d40-425e-86d8-5c3c9d700a74/documents/5103c1b5-9f74-417a-80a2-c1c2f79d3369_c7234e90-0d00-4067-b682-49f1854f3c9e.html,,,,,, Indole,120-72-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34ebfd63-0d40-425e-86d8-5c3c9d700a74/documents/5103c1b5-9f74-417a-80a2-c1c2f79d3369_c7234e90-0d00-4067-b682-49f1854f3c9e.html,Chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Indole,120-72-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): vapour pressure 1.6 Pa ( 0.016 hPa) - which is more than 0.1 Pa - no waiving possible. Particle size is less than 100 Micrometer than waiving is possible R7a guidance. Need to measure particle size MMAD ( mass median aerodynamic diameter) with laser diffraction. For it need to spraying the material. IF MMAD is more than 30 Micrometer, than waiving is possible based silicone article. If no waiving possible than need to measure it, since a fragrance has an inhalation route. Since inhalation route is more relevant than dermal route for fragrances, that is why it is recommended to have tested. If dermal acue toxicity is more relevant than no need inhalation acute toxicity. Indole is a natural metabolite found in the human body, from metabolisim of amino-acids, so it is found in human exhaled air. We have no control of the particle size of the perfume user. Need to have a read-across quotation from Manuela. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch 2 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34ebfd63-0d40-425e-86d8-5c3c9d700a74/documents/b16a89a9-06d5-42c4-a92f-bff962c977e0_c7234e90-0d00-4067-b682-49f1854f3c9e.html,,,,,, Indole,120-72-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34ebfd63-0d40-425e-86d8-5c3c9d700a74/documents/b16a89a9-06d5-42c4-a92f-bff962c977e0_c7234e90-0d00-4067-b682-49f1854f3c9e.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, Indole,120-72-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34ebfd63-0d40-425e-86d8-5c3c9d700a74/documents/b16a89a9-06d5-42c4-a92f-bff962c977e0_c7234e90-0d00-4067-b682-49f1854f3c9e.html,,dermal,LD50,790 mg/kg bw,adverse effect observed, Myo-inositol,87-89-8, Oral: QSAR predicted value; rat LC50: 194843.68 mg/kg. Reliability = 2 Inhalation: No study available Dermal: No study available ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2636673d-c059-4539-b3a0-d1d69b5f1411/documents/fc263977-8f1a-4249-9012-1bc0ed929ad2_affca42e-bf3a-4af6-abfa-78d31b0fb03f.html,,,,,, Myo-inositol,87-89-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2636673d-c059-4539-b3a0-d1d69b5f1411/documents/fc263977-8f1a-4249-9012-1bc0ed929ad2_affca42e-bf3a-4af6-abfa-78d31b0fb03f.html,,oral,LD50,"19,483.68 mg/kg bw",no adverse effect observed, 3-iodo-2-propynyl butylcarbamate,55406-53-6," Data on subchronic and chronic toxicity via oral route in rats, rabbits and mice indicate that a NOAEL of 20 mg/kg bw/d can be applied for the test item. Based on observations in a subchronic toxicity study applying dermal exposure to rats, NOEL was determined to be 50 mg/kg bw/d, whereas NOAEL was considered to be 200 mg/kg bw/d. In a subchronic inhalation toxicity study a NOAEC of 1.16 mg/m^3 was determined in rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de06560d-d9a6-490c-9f23-fdc6027da82f/documents/76eeaf89-58a8-42e5-8fa1-15261c4bc2b6_1074ed4a-02dd-44cd-8fee-84c57ed31344.html,,,,,, 3-iodo-2-propynyl butylcarbamate,55406-53-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de06560d-d9a6-490c-9f23-fdc6027da82f/documents/76eeaf89-58a8-42e5-8fa1-15261c4bc2b6_1074ed4a-02dd-44cd-8fee-84c57ed31344.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,200 mg/kg bw/day,,rat 3-iodo-2-propynyl butylcarbamate,55406-53-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de06560d-d9a6-490c-9f23-fdc6027da82f/documents/76eeaf89-58a8-42e5-8fa1-15261c4bc2b6_1074ed4a-02dd-44cd-8fee-84c57ed31344.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,1.16 mg/m3,,rat 3-iodo-2-propynyl butylcarbamate,55406-53-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de06560d-d9a6-490c-9f23-fdc6027da82f/documents/76eeaf89-58a8-42e5-8fa1-15261c4bc2b6_1074ed4a-02dd-44cd-8fee-84c57ed31344.html,Chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat 3-iodo-2-propynyl butylcarbamate,55406-53-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de06560d-d9a6-490c-9f23-fdc6027da82f/documents/76eeaf89-58a8-42e5-8fa1-15261c4bc2b6_1074ed4a-02dd-44cd-8fee-84c57ed31344.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1.16 mg/m3,adverse effect observed,rat 3-iodo-2-propynyl butylcarbamate,55406-53-6," Acute oral LD50 of the test item was determined to be 1056 mg/kg bw for female Sprague Dawley rats in an OECD 401 and GLP compliant study. The test item is considered non-toxic in rabbits, at a dose of 2000 mg/kg bw by dermal application, based upon the absence of mortality and criteria set forth by FIFRA. Acute inhalation LC50 of the test item was considered to be greater than 6.89 mg/L air for not respirable dust. However, clinical signs during exposure and post exposure were noted as well as a declined body weight in the treated group between day 2 and day 4 post exposure. Another study revealed LC50 of 0.67 mg/L for respirable dust and 0.763 mg/L for respirable liquid aerosol. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de06560d-d9a6-490c-9f23-fdc6027da82f/documents/2e854c45-1b15-4f02-8c05-ca5200ca212b_1074ed4a-02dd-44cd-8fee-84c57ed31344.html,,,,,, 3-iodo-2-propynyl butylcarbamate,55406-53-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de06560d-d9a6-490c-9f23-fdc6027da82f/documents/2e854c45-1b15-4f02-8c05-ca5200ca212b_1074ed4a-02dd-44cd-8fee-84c57ed31344.html,,oral,LD50,"1,056 mg/kg bw",adverse effect observed, 3-iodo-2-propynyl butylcarbamate,55406-53-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de06560d-d9a6-490c-9f23-fdc6027da82f/documents/2e854c45-1b15-4f02-8c05-ca5200ca212b_1074ed4a-02dd-44cd-8fee-84c57ed31344.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 3-iodo-2-propynyl butylcarbamate,55406-53-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de06560d-d9a6-490c-9f23-fdc6027da82f/documents/2e854c45-1b15-4f02-8c05-ca5200ca212b_1074ed4a-02dd-44cd-8fee-84c57ed31344.html,,inhalation,discriminating conc.,670 mg/m3,adverse effect observed, "(E)-4-(2,6,6-trimethyl-1-cyclohexen-1-yl)-3-buten-2-one",79-77-6,"Repeated dose toxicity:- sub-chronic, 90 days: NOAEL = 83 mg/kg bw/day (female), NOAEL = 71.8 mg/kg bw/day (male) (OECD 408)- 28 days: LOAEL = ca. 390-510 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d15cb671-6bfc-475d-8a05-af693bd26835/documents/IUC5-432be37d-2c8b-4f7c-8672-aaf35fc21874_072b60c1-8cb1-44df-b0b7-3aea182f39f9.html,,,,,, "(E)-4-(2,6,6-trimethyl-1-cyclohexen-1-yl)-3-buten-2-one",79-77-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d15cb671-6bfc-475d-8a05-af693bd26835/documents/IUC5-432be37d-2c8b-4f7c-8672-aaf35fc21874_072b60c1-8cb1-44df-b0b7-3aea182f39f9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,71.8 mg/kg bw/day,, "(E)-4-(2,6,6-trimethyl-1-cyclohexen-1-yl)-3-buten-2-one",79-77-6,"Acute Toxicity:- oral: LD50 5300 kg/kg bw (mouse)- dermaL. LD50 > 2000 mg/kg bw (rat; analogy mixed isomers, CAS 8013-90-9) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d15cb671-6bfc-475d-8a05-af693bd26835/documents/IUC5-f0b64177-2c0f-4f14-934f-a3ae0e48432b_072b60c1-8cb1-44df-b0b7-3aea182f39f9.html,,,,,, "(E)-4-(2,6,6-trimethyl-1-cyclohexen-1-yl)-3-buten-2-one",79-77-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d15cb671-6bfc-475d-8a05-af693bd26835/documents/IUC5-f0b64177-2c0f-4f14-934f-a3ae0e48432b_072b60c1-8cb1-44df-b0b7-3aea182f39f9.html,,oral,LD50,"5,300 mg/kg bw",, "(E)-4-(2,6,6-trimethyl-1-cyclohexen-1-yl)-3-buten-2-one",79-77-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d15cb671-6bfc-475d-8a05-af693bd26835/documents/IUC5-f0b64177-2c0f-4f14-934f-a3ae0e48432b_072b60c1-8cb1-44df-b0b7-3aea182f39f9.html,,dermal,LD50,"2,000 mg/kg bw",, Iron,7439-89-6,"Seven oral repeated dose studies (5 to 36 weeks) with carbonyl iron are available, which were largely focused on studying in rats the effects of iron overload as they are known from human pathological conditions and experiments with other iron species. Two inhalation studies (4 weeks, 6 h/day, 5 days/week) with rats are available in which carbonyl iron is compared with titanium dioxide. These studies yield the effects expected for poorly soluble particles in the rat on the alveolar macrophages, in cluding inflammation and increased cell proliferation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1850950f-d287-4263-97b9-baad8881729d/documents/IUC5-97d36722-3577-41f8-a30d-07b5a5bea847_3afbfddf-dcc2-4488-8ad0-61b4b7cefa89.html,,,,,, Iron,7439-89-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1850950f-d287-4263-97b9-baad8881729d/documents/IUC5-97d36722-3577-41f8-a30d-07b5a5bea847_3afbfddf-dcc2-4488-8ad0-61b4b7cefa89.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,5 mg/m3,,rat Iron,7439-89-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1850950f-d287-4263-97b9-baad8881729d/documents/IUC5-97d36722-3577-41f8-a30d-07b5a5bea847_3afbfddf-dcc2-4488-8ad0-61b4b7cefa89.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,26 mg/kg bw/day,,rat Iron,7439-89-6,"A series of oral acute toxicity studies with iron powders yielded LD50 values that were much higher than the limit below which which a substance needs to be classified for acute oral toxicity.A series of inhalation and intratracheal instillation studies showed carbonyl iron to be without effects on survival or local sublethal effects. Although the highest air concentration tested (250 mg/m^3) was lower than the upper threshold concentration determining classification, the results indicate that metallic iron needs not to be classified for acute inhalation toxicity.The lack of systemic bioavailability of iron upon dermal exposure makes testing for acute dermal toxicity redundant and allows for the conclusion that classification for this endpoint is not necessary. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1850950f-d287-4263-97b9-baad8881729d/documents/IUC5-becc38fc-da90-46cd-8a5a-d010b6b7c823_3afbfddf-dcc2-4488-8ad0-61b4b7cefa89.html,,,,,, Iron,7439-89-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1850950f-d287-4263-97b9-baad8881729d/documents/IUC5-becc38fc-da90-46cd-8a5a-d010b6b7c823_3afbfddf-dcc2-4488-8ad0-61b4b7cefa89.html,,oral,LD50,"7,500 mg/kg bw",adverse effect observed, Iron,7439-89-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1850950f-d287-4263-97b9-baad8881729d/documents/IUC5-becc38fc-da90-46cd-8a5a-d010b6b7c823_3afbfddf-dcc2-4488-8ad0-61b4b7cefa89.html,,inhalation,discriminating conc.,250 mg/m3,no adverse effect observed, Isopentyl acetate,123-92-2," oral: 7.5.1.001 (BG RCI (1990/91), Schilling et al. (1997)): At the highest dose of 1846.11 mg/kg bw/d (target substance) no effects were found for female animals wheras for male animals slight effects on haematology could be detected at the end of the 3-month test period. These were: Red blood cells: increase in the erythrocyte values, decrease in the mean corpuscular volume and decrease in the mean corpuscular hemoglobin content. The next lower dose was therefore pointed out to cause no adverse effects: NOAEL = ca. 435.68 mg/kg bw/d (actually received) (target substance). Effective concentrations of the source substance 3-Methylbutan-1-ol were re-calculated for the target substance isopentyl acetate using the MW. 7.5.1.002: range-finder study OECD TG 422, rat, 14 d. NOAEL = 369.22 mg/kg bw/d (sedation and mortality was found at 1476.9 mg/kg bw/d of target test substance (source substance:3-Methylbutan-1-ol) which was the highest dose tested). Effective concentrations of the source substance 3-Methylbutan-1-ol were re-calculated for the target substance isopentyl acetate using the MW. 7.5.1.003: OECD TG 422 study, rat, 42 d (m), 41-53 d (f), NOAEL =  443.07 mg/kg bw/d (target substance), NOEL = 147.69 mg/kg bw/d (target substance) (at the highest dose of 443.07 mg/kg bw/d (target substance) the body weight gain decreased in males; findings/changes evaluated to have no toxicological significance because of lack in dose-response relationship, for the following examinations: haematology, clinical chemistry, organ weights (thymus, rel. & absol. wt). Effective concentrations of the source substance 3-Methylbutan-1-ol were re-calculated for the target substance isopentyl acetate using the MW. 7.5.1.004 (Carpanini et al. (1973)): In a published subchronic toxicity study, 10 male and 10 female Ash/CSE rats were treated for 3 and 6 weeks with doses of  738.44 and 1476.9 mg/kg bw /day of the target substance (source substance 3-methylbutan-1-ol) by gavage (Carpanini et al. 1973). In addition, 30 male and 30 female Ash/CSE rats were treated for 17 weeks with doses of  221.53,  738.44 and 1476.9 mg/kg bw /day. Body weights were determined initially, at day 5 and then weekly. Food and water consumption were determined over a 24-hr period preceding the day of weighing. Urine was collected during week 3, 6, and 13. After sacrifice, haematological examinations, serum analyses, gross and histopathological examinations were performed. There were no effects associated with 17 weeks of treatment in the results of the haematological examinations, serum analyses, urinary cell counts, renal concentration tests or organ weights. The slightly reduced rate of body-weight gain (9%) observed at week 17 in the males at the highest dose level was shown to be due to a reduced food intake. Although two rats given 1476.9 mg/kg bw/day died, the histopathological examination showed that these deaths were due to dosing into the lungs and not to any toxic effects. NOEL =  738.44 mg/kg bw/d (effect on body weight of males at highest dose of 1476.9 mg/kg bw/d) of target source isopentyl acetate. Effective concentrations of the source substance isoamyl alcohol were re-calculated for the target substance isopentyl acetate using the MW. 7.5.1.005 (Gibel et al., Geschwulstforsch. 45/1: 19-24 (1975); Z Exper Chir 7: 235-239 (1974): rat, oral gav., A LOAEL of 34.11 mg/kg bw/d (target substance) could therefore be defined.   Effective concentrations of the source substance 3-Methylbutan-1-ol were re-calculated for the target substance isopentyl acetate using the MW. However, this LOAEL is eventually disregarded, adapting to the official opinion of MAK (1996) where the data of Gibel et al. (1974/1975) were disqualified. MAK evaluated the data quality to be questionable. In the study report of ""Study on the oral toxicity of 3-methylbutanol-1 in rats - Administration via the drinking water over 3 months"", Project No.: 33S0056/88020, performed by BASF (1990) and owned by BG RCI, was also referred to Gibel et al. (1974/1975). In the report is pointed out that the suspicion of carcinogenicity cannot be ruled out under consideration of the information in Gibel et al. (1974/1975) and that carcinogenity studies may therefore follow in the future. The German MAK Commission evaluated the data apparently different. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47cc5074-d76e-4821-9da1-c4a32b0b7ada/documents/2d4d40cd-169a-4e41-bbe6-95a4f8181dfd_4ac42103-494a-4517-8727-e0c49335ab5f.html,,,,,, Isopentyl acetate,123-92-2," Acute oral toxicity: LD50 Rabbit oral = 7400 mg/kg (HSDB: [American Conference of Governmental Industrial Hygienists, Inc. Documentation of the Threshold Limit Values and Biological Exposure Indices. 6th ed. Volumes I, II, III. Cincinnati, OH: ACGIH, 1991., p. 810]) LD50 rat oral = 16600 mg/kg (NIOSH (http://www.cdc.gov/niosh-rtecs/ns958940.html): Yakkyoku, 32, 1241-47, 1981, Nanzando, Tokyo, ISSN: 0044-0035) LD50 rabbit oral (Munch, J.C., Industrial medicine and surgery, Vol. 41, Nr. 4, 31-33, 19): - ND50: 32 mmol/kg (= 4160 mg/kg; calculated with a molar mass of 130) - LD50: 57 mmol/kg (= 7410 mg/kg; calculated with a molar mass of 130) Acute dermal toxicity (review: OPDYKE D L J, FOOD COSMET TOXICOL, 13 (5), 545-554, 1975. original source mentioned: Moreno, O.M. (1973). Report to RIFM, 1 February.): - LD50 rabbit > 5 g/kg Acute inhalation toxicity: Acute toxicity of ""i-Amylacetat"" to the cat, deep narcosis after 75 and 85 min at 56 mg/l in the air and after 110 and 105 min at 51 mg/l (replicates determined respectively). Ferdinand Flury und Wolfgang Wirth,  International Archives of Occupational and Environmental Health Springer Berlin / Heidelberg  ISSN 0340-0131 (Print), Heft Volume 5, Number 1, Seiten 1-90, Dezember 1933, DOI 10.1007/BF02274996 Acute toxicity other routes: LD50 guinea pig (one animal), Applied dose subcutaneous per body weight of animal (g/kg): 5 After 1/2 hour deep narcosis, thereafter rear extremities paralysed. Death after 6 days.  Ferdinand Flury und Wolfgang Wirth,  International Archives of Occupational and Environmental Health Springer Berlin / Heidelberg  ISSN 0340-0131 (Print), Heft Volume 5, Number 1, Seiten 1-90, Dezember 1933, DOI 10.1007/BF02274996 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47cc5074-d76e-4821-9da1-c4a32b0b7ada/documents/90fd6284-020c-41cd-b499-ec1ab42d9ab6_4ac42103-494a-4517-8727-e0c49335ab5f.html,,,,,, Isopentyl acetate,123-92-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47cc5074-d76e-4821-9da1-c4a32b0b7ada/documents/90fd6284-020c-41cd-b499-ec1ab42d9ab6_4ac42103-494a-4517-8727-e0c49335ab5f.html,,oral,LD50,"7,400 mg/kg bw",, 3-methylbutan-1-ol,123-51-3,The oral NOAEL for subchronic oral toxicity was found to be approximately 1250 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9440c57-3a91-46fa-bbc0-42ab7177167b/documents/IUC5-8de299fd-2c6e-45b8-bad5-35d4c039e134_26fca49d-cc7c-499a-9f49-314f0f941dd2.html,,,,,, 3-methylbutan-1-ol,123-51-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9440c57-3a91-46fa-bbc0-42ab7177167b/documents/IUC5-8de299fd-2c6e-45b8-bad5-35d4c039e134_26fca49d-cc7c-499a-9f49-314f0f941dd2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 3-methylbutan-1-ol,123-51-3,"oral:   LD50 > 5000mg/kg   Additionally, all LD50 values of the category members were found to be far greater than 2000 mg/kg bw.   inhalation:   No mortalities occured when 3-methylbutan-1-ol or the read-across substances were applied as vapour. In a study in which CAS 94624-12-1 was applied as an aerosol, the LC50 in mice was found to be below 14 mg/L, but above 14mg/L in rats and guinea pigs.   dermal:   All the dermal LD50 value were found to be greater than 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9440c57-3a91-46fa-bbc0-42ab7177167b/documents/IUC5-9c19ac12-4681-4976-9cdf-938b2540339a_26fca49d-cc7c-499a-9f49-314f0f941dd2.html,,,,,, 3-methylbutan-1-ol,123-51-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9440c57-3a91-46fa-bbc0-42ab7177167b/documents/IUC5-9c19ac12-4681-4976-9cdf-938b2540339a_26fca49d-cc7c-499a-9f49-314f0f941dd2.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, 3-methylbutan-1-ol,123-51-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9440c57-3a91-46fa-bbc0-42ab7177167b/documents/IUC5-9c19ac12-4681-4976-9cdf-938b2540339a_26fca49d-cc7c-499a-9f49-314f0f941dd2.html,,dermal,LD50,"3,216 mg/kg bw",adverse effect observed, 3-methylbutan-1-ol,123-51-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9440c57-3a91-46fa-bbc0-42ab7177167b/documents/IUC5-9c19ac12-4681-4976-9cdf-938b2540339a_26fca49d-cc7c-499a-9f49-314f0f941dd2.html,,inhalation,discriminating conc.,"11,000 mg/m3",no adverse effect observed, Allyl (3-methylbutoxy)acetate,67634-00-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch 1 ( GLP) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8f71fdb-742a-4282-88cb-a88043d62fdc/documents/c2878f9c-e555-4bae-b6eb-53cd7b716335_32306238-68c7-4c4a-8d35-b45c562396e8.html,,,,,, Allyl (3-methylbutoxy)acetate,67634-00-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8f71fdb-742a-4282-88cb-a88043d62fdc/documents/c2878f9c-e555-4bae-b6eb-53cd7b716335_32306238-68c7-4c4a-8d35-b45c562396e8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Allyl (3-methylbutoxy)acetate,67634-00-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Based on the results obtained and in line with OECD 402 the acute dermal LD50 of the given test item Allyl Amyl Glycolate (Batch No. AAG-TEST 1) is greater than 2000 mg/Kg b.w. CLP criteria not met. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8f71fdb-742a-4282-88cb-a88043d62fdc/documents/19da33c5-4e6b-466d-923a-3b5f8f625ace_32306238-68c7-4c4a-8d35-b45c562396e8.html,,,,,, Allyl (3-methylbutoxy)acetate,67634-00-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8f71fdb-742a-4282-88cb-a88043d62fdc/documents/19da33c5-4e6b-466d-923a-3b5f8f625ace_32306238-68c7-4c4a-8d35-b45c562396e8.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Allyl (3-methylbutoxy)acetate,67634-00-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8f71fdb-742a-4282-88cb-a88043d62fdc/documents/19da33c5-4e6b-466d-923a-3b5f8f625ace_32306238-68c7-4c4a-8d35-b45c562396e8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Allyl (3-methylbutoxy)acetate,67634-00-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8f71fdb-742a-4282-88cb-a88043d62fdc/documents/19da33c5-4e6b-466d-923a-3b5f8f625ace_32306238-68c7-4c4a-8d35-b45c562396e8.html,,inhalation,LC50,430 mg/m3,adverse effect observed, 3-methylbutyl butyrate,106-27-4,"In a combined repeated dose toxicity 28-day / Reproduction/Developmental Toxicity Screening Test in rats (OECD 422), the No Observed Adverse Effect Level (NOAEL) for isoamyl isovalerate as a read-across substance was 800 mg/kg bw/day (top dose). In consideration of the molecular weight of both source and target substances (172.27 and 158.24 g/mol) the No Observed Adverse Effect Levels (NOAELs) of the test item isoamyl butyrate for general toxicity effects and reproduction/developmental toxicity was 734.85 mg/kg/day. Using this read across approach, the target substance has not to be classified for long term toxicity endpoints according to CLP. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The key study was a read across from a good quality study, conducted using OECD Guideline 422 and complies with GLP and was therefore assigned 1 (reliable without restrictions). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ed8a3c3-207c-4e84-977e-f0b4423f601d/documents/c9c4ecae-e2a5-4e36-8ba5-c884a481d7a6_58cc5c4a-dd65-4be5-9bd8-1ee51e8867f9.html,,,,,, 3-methylbutyl butyrate,106-27-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ed8a3c3-207c-4e84-977e-f0b4423f601d/documents/c9c4ecae-e2a5-4e36-8ba5-c884a481d7a6_58cc5c4a-dd65-4be5-9bd8-1ee51e8867f9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,734.85 mg/kg bw/day,,rat 3-methylbutyl butyrate,106-27-4,"The test item is considered to have a low acute toxicity by the oral and dermal route. In rats, the LD50 value via the oral route is > 5000 mg/kg bw (value derived from the read-across compound isoamyl isovalerate). In consideration of the molecular weight of the source and target substances (172.27 and 158.24 g/mol), the corrected LD50 for the target substance is > 4592.8 mg/kg bw. Furthermore, a supporting oral toxicity study with the test substance isoamyl butyrate supports this result (LD50 value >5000 mg/kg bw). Mortality after dermal exposure to the test item is not expected as a supporting acute dermal toxicity study as well as the in vivo acute oral toxicity study (value derived from read-across compound isoamyl isovalerate) showed no effects up to 5000 mg/kg bw and 4592.8 mg/kg bw, respectively. For this reason, a further acute dermal toxicity study will be waived. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The key study was assigned reliability 1: reliable without restrictions. However, these data have been scored as reliability 2: reliable with restrictions when used for read across to the target test substance. The supporting study, based on the test substance, has been identified as reliability 4, due to the limited available data. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The supporting study, based on the test substance, has been identified as reliability 4, due to the limited available data. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ed8a3c3-207c-4e84-977e-f0b4423f601d/documents/20dcb634-d6fd-451b-81bf-86426fadf74b_58cc5c4a-dd65-4be5-9bd8-1ee51e8867f9.html,,,,,, 3-methylbutyl butyrate,106-27-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ed8a3c3-207c-4e84-977e-f0b4423f601d/documents/20dcb634-d6fd-451b-81bf-86426fadf74b_58cc5c4a-dd65-4be5-9bd8-1ee51e8867f9.html,,oral,LD50,"4,592.8 mg/kg bw",no adverse effect observed, 3-methylbutyl butyrate,106-27-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ed8a3c3-207c-4e84-977e-f0b4423f601d/documents/20dcb634-d6fd-451b-81bf-86426fadf74b_58cc5c4a-dd65-4be5-9bd8-1ee51e8867f9.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, 3-methylbutyl isovalerate,659-70-1," In the key Combined Repeated Dose Toxicity 28-day / Reproduction/Developmental Toxicity Screening Test in rats (OECD 422), the No Observed Adverse Effect Level (NOAEL) for the test item was 800 mg/kg bw/day (top dose). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c51c8f1-7055-43d7-9fad-77c7becb3e33/documents/6e9fc4e8-20a1-4c7e-ac5b-d16e9c10b6e4_13529fcb-33cd-4714-abd7-5df63f591cec.html,,,,,, 3-methylbutyl isovalerate,659-70-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c51c8f1-7055-43d7-9fad-77c7becb3e33/documents/6e9fc4e8-20a1-4c7e-ac5b-d16e9c10b6e4_13529fcb-33cd-4714-abd7-5df63f591cec.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,800 mg/kg bw/day,,rat 3-methylbutyl isovalerate,659-70-1," The test item has a low acute toxicity by the oral and dermal route. In rats, the LD50 value via the oral route is > 5000 mg/kg bw. In rats, the LD50 value via the dermal route is > 2000 mg/kg bw (value derived from Read -across substance Ethyl propionate). The  recalculated value to correct differences in molecular weight between source (MW 102.132) and target (MW 172. 2646) was > 3373.37 mg/kg bw isoamyl isovalerate. . ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c51c8f1-7055-43d7-9fad-77c7becb3e33/documents/ebf509e6-b7be-4ba2-b387-45b8868b6382_13529fcb-33cd-4714-abd7-5df63f591cec.html,,,,,, 3-methylbutyl isovalerate,659-70-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c51c8f1-7055-43d7-9fad-77c7becb3e33/documents/ebf509e6-b7be-4ba2-b387-45b8868b6382_13529fcb-33cd-4714-abd7-5df63f591cec.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 3-methylbutyl isovalerate,659-70-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c51c8f1-7055-43d7-9fad-77c7becb3e33/documents/ebf509e6-b7be-4ba2-b387-45b8868b6382_13529fcb-33cd-4714-abd7-5df63f591cec.html,,dermal,LD50,"3,373.37 mg/kg bw",no adverse effect observed, Isopentyl laurate,6309-51-9,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7f1e1a97-b636-4878-87d0-fc71aad1c922/documents/IUC5-2be39757-41f7-4a49-b03d-300254e7bacb_f881fadf-e636-43c0-bc9c-5b60d5c9088a.html,,,,,, Isopentyl laurate,6309-51-9,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f1e1a97-b636-4878-87d0-fc71aad1c922/documents/IUC5-b7765b29-fc70-4101-8017-28197aa32203_f881fadf-e636-43c0-bc9c-5b60d5c9088a.html,,,,,, Isopentyl p-methoxycinnamate,71617-10-2,"SUBACUTE STUDYThe effects of isopentyl p-methoxycinnamate were examined in a preliminary experiment with 3-week oral application by gavage to Sprague-Dawley rats (5 males and 5 females per group), using daily doses of 0.3, 0.9, and 2.7 mL/kg bw (312, 936, and 2808 mg/kg bw ) in 0.8% hydroxypropyl cellulose gel or the vehicle only at a constant volume of 5 mL/kg bw. The lowest dose of isopentyl p-methoxycinnamate causing observable adverse effects (LOAEL) was estimated within the range of 0.9 mL/kg to 2.7 mL/kg bw/d (corresponding to 936 to 2808 mg/kg/day). SUBCHRONIC STUDYIn this study, groups of 15 male and 15 female Wistar rats each received isopentyl p-methoxycinnamate daily by gavage in dosages of 20, 200, and 2000 mg/kg body weight in polyethylene glycol over a period of 13 weeks. The no observed adverse effect level (NOAEL) for isopentyl p-methoxycinnamate was determined at 200 mg/kg. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79c97595-03de-41c4-afc2-bb57f684749b/documents/IUC5-abbeabbf-f0f7-4c9a-acb8-91f81739c7f2_8da59b62-0e01-4f71-bb3b-9801699d9cae.html,,,,,, Isopentyl p-methoxycinnamate,71617-10-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79c97595-03de-41c4-afc2-bb57f684749b/documents/IUC5-abbeabbf-f0f7-4c9a-acb8-91f81739c7f2_8da59b62-0e01-4f71-bb3b-9801699d9cae.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Isopentyl p-methoxycinnamate,71617-10-2,"Acute oral toxicity The acute toxicity of isopentyl p-methoxycinnamate was evaluated in two studies in male and female Sprague-Dawley rats using the oral and the dermal route of application.In the oral toxicity study, LD50 values of 9,900 mg/kg bw and 9,600 mg/kg bw, were obtained for males and females, respectively.Acute dermal toxicity In the dermal toxicity study, the LD50 value was determined to be greater than 20,000 mg/kg bw.Thus, isopentyl p-methoxycinnamate showed a very low degree of acute toxicity after administration by either route. Acute inhalation toxicityThe acute inhalative toxicity of isopentyl p-methoxycinnamate was not studied, since the inhalative route is not considered relevant for this compound. This assumption is based on the facts that the vapour pressure of isopentyl p-methoxycinnamate is low (0.000014 hPa at 25°C, see section 4.6 of this IUCLID dataset) and exposure to aerosols, particles, or droplets of an inhalable size is unlikely, since isopentyl p-methoxycinnamate is exclusively used as a sunscreen agent in cosmetic products like solar oil which are not applied as a spray. Moreover, the conditions used in the manufacturing and formulation process of isopentyl p-methoxycinnamate not suggest a significant exposure via air. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79c97595-03de-41c4-afc2-bb57f684749b/documents/IUC5-9fe0be6f-59e7-4cb9-8f63-05af231c8a4b_8da59b62-0e01-4f71-bb3b-9801699d9cae.html,,,,,, Isopentyl p-methoxycinnamate,71617-10-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79c97595-03de-41c4-afc2-bb57f684749b/documents/IUC5-9fe0be6f-59e7-4cb9-8f63-05af231c8a4b_8da59b62-0e01-4f71-bb3b-9801699d9cae.html,,oral,LD50,"9,600 mg/kg bw",, Isopentyl p-methoxycinnamate,71617-10-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79c97595-03de-41c4-afc2-bb57f684749b/documents/IUC5-9fe0be6f-59e7-4cb9-8f63-05af231c8a4b_8da59b62-0e01-4f71-bb3b-9801699d9cae.html,,dermal,LD50,"20,000 mg/kg bw",no adverse effect observed, Isopentyl phenylacetate,102-19-2," Acute toxicity: Oral Acute oral toxicity study was done in rats using test chemical.No mortality was observed at dose 5000 mg/kg bw. Hence,LD50 value was considered to be >5000 mg/kg bw,when rats were treated with test chemical orally. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/059c14ae-6ebb-41fa-8243-758235aba68e/documents/5f0f35f9-7a2c-4d9c-866f-14d0130d9092_b2f84f2a-c993-41cc-bb05-9604a59a4dcc.html,,,,,, Isopentyl phenylacetate,102-19-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/059c14ae-6ebb-41fa-8243-758235aba68e/documents/5f0f35f9-7a2c-4d9c-866f-14d0130d9092_b2f84f2a-c993-41cc-bb05-9604a59a4dcc.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Isopentyl propionate,105-68-0, Acute oral toxicity: LD50 was considered to be 6924 mg/kg bw when rabbits were treated with 3-Methylbutyl propionate orally. Acute dermal toxicity: LD50 was considered to be > 4324.5 mg/kg bw when rabbits were treated with 3-Methylbutyl propionate. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a31a2f60-d280-4f0a-84d9-057e0daf0028/documents/42853d25-8ebd-4b6a-84c5-517e0a6ea632_d530d93b-fe64-4250-89cf-a4d93ebc73e7.html,,,,,, Isopentyl propionate,105-68-0,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a31a2f60-d280-4f0a-84d9-057e0daf0028/documents/42853d25-8ebd-4b6a-84c5-517e0a6ea632_d530d93b-fe64-4250-89cf-a4d93ebc73e7.html,,oral,LD50,"6,924 mg/kg bw",no adverse effect observed, Isopentyl propionate,105-68-0,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a31a2f60-d280-4f0a-84d9-057e0daf0028/documents/42853d25-8ebd-4b6a-84c5-517e0a6ea632_d530d93b-fe64-4250-89cf-a4d93ebc73e7.html,,dermal,LD50,"4,324.5 mg/kg bw",no adverse effect observed, Isopentyl salicylate,87-20-7," The LD50 of the source substance is 1310 mg/kg bw. In consideration of the molecular weight of both substances (208.25 and 194.2 g/mol), the corrected LD50 for the target substance is 1406.2 mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4e89b5d-83d2-48e6-b232-2d7034af5c6e/documents/IUC5-eb0d82e4-39c9-4daa-af67-dbdee9a0ef68_8b2de0a7-29e8-4eb3-af51-ac791dae1752.html,,,,,, Isopentyl salicylate,87-20-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4e89b5d-83d2-48e6-b232-2d7034af5c6e/documents/IUC5-eb0d82e4-39c9-4daa-af67-dbdee9a0ef68_8b2de0a7-29e8-4eb3-af51-ac791dae1752.html,,oral,LD50,"1,406 mg/kg bw",adverse effect observed, Isopentyl benzoate,94-46-2, Acute oral toxicity: LD50 was considered to be 6300 mg/kg bw when rats were treated with 3-methylbutyl benzoate orally. Acute dermal toxicity: LD50 was considered to be > 5000 mg/kg bw when rabbits were treated with 3-methylbutyl benzoate dermally. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37d8602f-19eb-4724-a5a1-c0b8f6642ce7/documents/551b59cd-bcf0-40a6-af52-3c292db2cab6_652fc1c6-75da-494c-aa0e-00928185e2a2.html,,,,,, Isopentyl benzoate,94-46-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37d8602f-19eb-4724-a5a1-c0b8f6642ce7/documents/551b59cd-bcf0-40a6-af52-3c292db2cab6_652fc1c6-75da-494c-aa0e-00928185e2a2.html,,oral,LD50,"6,300 mg/kg bw",no adverse effect observed, Isopentyl benzoate,94-46-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37d8602f-19eb-4724-a5a1-c0b8f6642ce7/documents/551b59cd-bcf0-40a6-af52-3c292db2cab6_652fc1c6-75da-494c-aa0e-00928185e2a2.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Exo-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol",124-76-5," Key study: Read-across approach. Test method similar to OECD 408. No data on GLP. Based on the read-across approach, the NOEL for isoborneol after an oral exposure of 13 weeks was determined to be 11.79 mg/kg bw/day in rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bedf6259-ac27-469f-b333-1683bb2ab5c2/documents/198d9c9e-6835-4d85-861b-5fd3c44a6edc_91137234-d749-4b84-a031-0d2af27d36e3.html,,,,,, "Exo-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol",124-76-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bedf6259-ac27-469f-b333-1683bb2ab5c2/documents/198d9c9e-6835-4d85-861b-5fd3c44a6edc_91137234-d749-4b84-a031-0d2af27d36e3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,11.79 mg/kg bw/day,,rat "Exo-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol",124-76-5," Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue L-borneol, the acute oral LD50 value of isoborneol is 6500 mg/kg bw in rats. Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of isoborneol is >7859 mg/kg bw in rats. Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of isoborneol is 7072 mg/kg bw in mice. Acute oral toxicity: Supporting study: The acute oral LD50 value of isoborneol is 5200 mg/kg bw in rats. Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue L-Borneol, the acute dermal LD50 value of isoborneol was determined to be greater than 2000 mg/kg bw in rabbits. Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue isobornyl acetate, the acute dermal LD50 value of isoborneol was determined to be greater than 15717 mg/kg bw in rabbits. Acute dermal toxicity: Supporting study: The acute dermal LD50 value of isoborneol is higher than 5000 mg/kg bw in rabbits. Acute inhalation toxicity: Data waiving (study scientifically not necessary): According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route needs to be provided. The information is provided for dermal route. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bedf6259-ac27-469f-b333-1683bb2ab5c2/documents/642bcbad-62d1-4251-b02e-217309bea9e6_91137234-d749-4b84-a031-0d2af27d36e3.html,,,,,, "Exo-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol",124-76-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bedf6259-ac27-469f-b333-1683bb2ab5c2/documents/642bcbad-62d1-4251-b02e-217309bea9e6_91137234-d749-4b84-a031-0d2af27d36e3.html,,oral,LD50,"6,500 mg/kg bw",no adverse effect observed, "Exo-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol",124-76-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bedf6259-ac27-469f-b333-1683bb2ab5c2/documents/642bcbad-62d1-4251-b02e-217309bea9e6_91137234-d749-4b84-a031-0d2af27d36e3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate",125-12-2,Repeated dose toxicity oral: key study: results from a publication leading to the conclusion that NOEL is 15 mg/kg bw/day for rats. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9fe687f-6cfd-44c5-98b3-6db909ec48c7/documents/88b06600-c596-4c4a-b2a1-a6aebcbce1f9_1a3bba63-6c4a-4a28-adc1-96f3d9ec36fd.html,,,,,, "Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate",125-12-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9fe687f-6cfd-44c5-98b3-6db909ec48c7/documents/88b06600-c596-4c4a-b2a1-a6aebcbce1f9_1a3bba63-6c4a-4a28-adc1-96f3d9ec36fd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate",125-12-2,Acute toxicity oral: LD50 for rats is greater than 10000 mg/kg bw.Acute toxicity: dermal: LD50 is 20000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9fe687f-6cfd-44c5-98b3-6db909ec48c7/documents/1a79ab3a-d94d-4e3c-9772-d386db0a5d53_1a3bba63-6c4a-4a28-adc1-96f3d9ec36fd.html,,,,,, "Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate",125-12-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9fe687f-6cfd-44c5-98b3-6db909ec48c7/documents/1a79ab3a-d94d-4e3c-9772-d386db0a5d53_1a3bba63-6c4a-4a28-adc1-96f3d9ec36fd.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acetate",125-12-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9fe687f-6cfd-44c5-98b3-6db909ec48c7/documents/1a79ab3a-d94d-4e3c-9772-d386db0a5d53_1a3bba63-6c4a-4a28-adc1-96f3d9ec36fd.html,,dermal,LD50,"20,000 mg/kg bw",no adverse effect observed, "Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate",5888-33-5," IBOA/ target substance Subacute NOAEL general systemic toxicity, rat, oral gavage: 100 mg/kg bw/d due to clinical chemistry effects (increased urea; indicative for effects on the hepatobiliar system; IBOA, OECD 422, GLP) Metabolite and metabolite donor data subchronic NOAEL general toxicity, rat, oral, drinking water: 83 mg/kg bw/d due to unspecific effects considered as secondary to unpalatibility of the test item (Acrylic Acid, 90d, pre-guideline) NOAEL general toxicity, rat, oral, drinking water: 84/111 mg/kg bw/d due to unspecific effects considered as secondary to unpalatibility of the test item (Butyl Acrylate, 90d, similar to OECD 408) NOAEL (general toxicity, rat, oral, gavage: 15 mg/kg bw/d due to liver effects (Isobornyl Acetate, 13 weeks, similar to OECD 408) chronic NOAEL general toxicity, rat, oral, drinking water: 61 mg/kg bw/d due to unspecific effects considered as secondary to unpalatibility of the test item (Acrylic Acid, 12 months, comparable to OECD 452) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d8aed5b-fdac-4dd2-944d-c9d45e91efd3/documents/IUC5-dd62b43b-2245-4122-aa8b-2b1f59de3140_380a13ba-85ac-4615-ae26-0d718a472b43.html,,,,,, "Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate",5888-33-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d8aed5b-fdac-4dd2-944d-c9d45e91efd3/documents/IUC5-dd62b43b-2245-4122-aa8b-2b1f59de3140_380a13ba-85ac-4615-ae26-0d718a472b43.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate",5888-33-5," LD50 oral, rat: 4350 mg/kg bw LD50 dermal, rabbit: > 30000 mg/kg inhalation: no data available/ no relevant pathway of exposure due to the low VP ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d8aed5b-fdac-4dd2-944d-c9d45e91efd3/documents/IUC5-29079058-91a4-4e41-bbff-523ea8516273_380a13ba-85ac-4615-ae26-0d718a472b43.html,,,,,, "Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate",5888-33-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d8aed5b-fdac-4dd2-944d-c9d45e91efd3/documents/IUC5-29079058-91a4-4e41-bbff-523ea8516273_380a13ba-85ac-4615-ae26-0d718a472b43.html,,oral,LD50,"4,350 mg/kg bw",no adverse effect observed, "Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl acrylate",5888-33-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d8aed5b-fdac-4dd2-944d-c9d45e91efd3/documents/IUC5-29079058-91a4-4e41-bbff-523ea8516273_380a13ba-85ac-4615-ae26-0d718a472b43.html,,dermal,discriminating dose,"3,000 mg/kg bw",no adverse effect observed, "Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate",7534-94-3," IBOMA OECD 421, GLP, rat, oral: NOAEL systemic toxicity 25 mg/kg bw/day (based on liver and kidney findings) Metabolite data MMA (metabolite donor for MAA) 2 yrs, rat, drinking water: NOAEL 2000 ppm (no adverse effects found) NTP, 2 yrs, rat, inhalation: NOAEC systemic toxicity 500 ppm; LOAEC local toxicity 250 ppm MAA OECD 413, GLP, 90 d, rat, inhalation: NOAEC systemic & local toxicity 100 ppm IBOAc (metabolite donor for IBO) OECD 408, 90 d, rat, oral gavage: NOAEL systemic 15 mg/kg bw/day (based on liver and kidney findings) In conclusion, the overall database does not justify a classification of isobornyl methacrylate as dangerous to human health with respect to specific target organ toxicity at repeated exposure. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/270cd404-b49f-4b7c-bc23-978364b6eabc/documents/2de116b6-3d1a-4dc9-aaab-4df180a687ae_8b0965a4-b5af-4656-a1e8-43012c30e540.html,,,,,, "Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate",7534-94-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/270cd404-b49f-4b7c-bc23-978364b6eabc/documents/2de116b6-3d1a-4dc9-aaab-4df180a687ae_8b0965a4-b5af-4656-a1e8-43012c30e540.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat "Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate",7534-94-3," Isobornyl methacrylate is of low toxicity by oral route (LD50rat >= 2000 mg/kg). No fully reliable data are available for the dermal and inhalation routes. Due to the low vapour pressure of isobornyl methacrylate, inhalation is not considered as a relevant pathway of exposure. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/270cd404-b49f-4b7c-bc23-978364b6eabc/documents/fb9de650-db23-44f8-a5e6-0bea20d6192f_8b0965a4-b5af-4656-a1e8-43012c30e540.html,,,,,, "Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl methacrylate",7534-94-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/270cd404-b49f-4b7c-bc23-978364b6eabc/documents/fb9de650-db23-44f8-a5e6-0bea20d6192f_8b0965a4-b5af-4656-a1e8-43012c30e540.html,,oral,LD50,"2,000 mg/kg bw",, "Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl propionate",2756-56-1, The NOAEL of Isobornyl propionate is >=270 mg/kg bw based on read across from a sub-chronic study carried out with Isobornyl acetate (similar to OECD 408) and supported with information from a sub-chronic study with Cyclacet. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/28dc1810-45a4-4ce9-bf7e-d9309e411e68/documents/dfdfdbf5-faeb-4c7b-aa35-c16d585c972d_0061147c-6e4b-4e4f-9d8b-3e942309d0be.html,,,,,, "Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl propionate",2756-56-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/28dc1810-45a4-4ce9-bf7e-d9309e411e68/documents/dfdfdbf5-faeb-4c7b-aa35-c16d585c972d_0061147c-6e4b-4e4f-9d8b-3e942309d0be.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,270 mg/kg bw/day,,rat "Exo-1,7,7-trimethylbicyclo[2.2.1]hept-2-yl propionate",2756-56-1, Acute oral toxicity (similar to OECD TG 401): LD50 > 5000 mg/kg bw Acute inhalation toxicity derived by route to route extrapolation LC50 >13000 mg/m3 Acute dermal toxicity (similar to OECD TG 402): LD50 > 5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28dc1810-45a4-4ce9-bf7e-d9309e411e68/documents/85b40fbc-2715-4af1-8ab2-2d67d6ec3810_0061147c-6e4b-4e4f-9d8b-3e942309d0be.html,,,,,, Isobutane,75-28-5," Members of the Petroleum Gases category show low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration for the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/728bf4fb-b8d5-43a2-ac5c-eb1d2b216341/documents/b721eb2d-40a4-4218-82f6-fa011ddca2e8_81652f5f-074f-4eca-831c-af2c9fb457ed.html,,,,,, Isobutane,75-28-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/728bf4fb-b8d5-43a2-ac5c-eb1d2b216341/documents/b721eb2d-40a4-4218-82f6-fa011ddca2e8_81652f5f-074f-4eca-831c-af2c9fb457ed.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"4,437 mg/m3",,rat Isobutane,75-28-5," The LC50 in mice of a mixture of isobutane, butane, and propane is 57.42% (approximately 539,600 ppm). The LC50 in rats of propane exceeds 800000 ppm (equivalent to 1,442,738 mg/m3 or 1443 mg/L)). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/728bf4fb-b8d5-43a2-ac5c-eb1d2b216341/documents/e2a1c422-b9eb-4d66-96a7-2e6bdee5435c_81652f5f-074f-4eca-831c-af2c9fb457ed.html,,,,,, Tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran,16409-43-1,"Repeated dose toxicity – oral: subchronic study; rat, feed; OECD TG 408, GLP (BASF 50C0087/18S026): NOAEL (male) = 12 000 ppm (1547 mg/kg bw/day); NOAEL (female) = 12 000 ppm (1620 mg/kg bw/day) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ae632f0b-c19c-4462-8f6b-9484f3512a18/documents/IUC5-e882d3d5-cbfe-4862-8395-4c0d31a8fca4_718b76f0-0c19-42a1-98da-5340b38c46ea.html,,,,,, Tetrahydro-4-methyl-2-(2-methylprop-1-enyl)pyran,16409-43-1,"Acute oral toxicity (OECD TG 423): LD50 > 2000 mg/kg bw trans-rose oxide (Symrise, 2001)Acute dermal toxicity: LD50 > 5000 mg/kg cis-rose oxide (Moreno 1973); LD50 > 2000 mg/kg bw dihydro-rose oxid (BASF 1984; 83/186) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae632f0b-c19c-4462-8f6b-9484f3512a18/documents/IUC5-ec61ed31-3b94-4070-822f-794b9b9927e2_718b76f0-0c19-42a1-98da-5340b38c46ea.html,,,,,, Isobutyl 2-naphthyl ether,2173-57-1," Repeated dose toxicity information, NOAEL 100 mg/kg bw in an OECD TG 407 study (SIDS dossier) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b837f9e-ec4c-4dc6-bc56-50d1d34e8504/documents/b308fd71-7074-45df-8e00-33592fa0ed61_2498f40c-0e81-4389-93b7-1ec85f528ab1.html,,,,,, Isobutyl 2-naphthyl ether,2173-57-1, Acute oral toxicity (study similar to OECD TG 401): LD50 > 5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b837f9e-ec4c-4dc6-bc56-50d1d34e8504/documents/b01356cf-6dfb-4b16-b983-8ba9b7bdb443_2498f40c-0e81-4389-93b7-1ec85f528ab1.html,,,,,, Isobutyl acetate,110-19-0,"For isobutyl acetate, no data on repeated dose toxicity could be located.To compensate for this lack of data, information resulting from isobutanol and isobutyl isobutyrate as supporting substances will be used as substitute. Data are available for oral and inhalation repeated dose toxicity.Repeated dose toxicity: oral (gavage)Supporting substance isobutanol: In a valid subchronic (90 d) toxicity studies, a NOAEL of 316 mg/kg bw/day has been observed (EPA/Res. Triangle Inst. 1987).The NOAEL for isobutyl acetate (conversion using the respective molecular weight) is 495 mg/kg bw/day.Supporting substance isobutyl isobutyrate: In a valid subchronic (90 d) toxicity studies, a NOAEL of 1000 mg/kg bw/day has been observed (Drake 1978).The NOAEL for isobutyl acetate (conversion using the respective molecular weight) is 805 mg/kg bw/dayRepeated dose toxicity: inhalationSupporting subsance n-butyl acetae: In a valid subchronic (90 d) toxicity study, the NOAEL was considered to be 2410 mg/m³ (OPP/CMA, 1998 and 2001)Supporting substance isobutanol: In a valid subchronic (90 d) toxicity study, the NOAEL was considered to be 7700 mg/m³ (Li/Monsanto 1999). The NOAEC for isobutyl acetate (conversion using the respective molecular weight) is 12067 mg/m³.The findings of these studies indicate that the substance is neurotoxic and may induce narcosis. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/891482c4-db26-46ca-936a-943956a1f453/documents/IUC5-2a631488-7b2a-43e5-bb79-3112a0fe99fe_ce4e1303-d4ee-421a-beb4-98117569ef32.html,,,,,, Isobutyl acetate,110-19-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/891482c4-db26-46ca-936a-943956a1f453/documents/IUC5-2a631488-7b2a-43e5-bb79-3112a0fe99fe_ce4e1303-d4ee-421a-beb4-98117569ef32.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,495 mg/kg bw/day,,rat Isobutyl acetate,110-19-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/891482c4-db26-46ca-936a-943956a1f453/documents/IUC5-2a631488-7b2a-43e5-bb79-3112a0fe99fe_ce4e1303-d4ee-421a-beb4-98117569ef32.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"2,410 mg/m3",,rat Isobutyl acetate,110-19-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/891482c4-db26-46ca-936a-943956a1f453/documents/IUC5-2a631488-7b2a-43e5-bb79-3112a0fe99fe_ce4e1303-d4ee-421a-beb4-98117569ef32.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"2,410 mg/m3",adverse effect observed,rat Isobutyl acetate,110-19-0,"The oral LD50 of isobutyl acetate was determined to be 13413 mg/kg bw in male rats (Smyth, 1962).The inhalation LC50 of isobutyl acetate is assessed to be approximately 30 mg/L in rats (Smyth, 1962 and supporing studies).The dermal LD50 of isobutyl acetate was determined to be > 17,400 mg/kg in male rabbits (Smyth, 1962). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/891482c4-db26-46ca-936a-943956a1f453/documents/IUC5-3ffae477-075b-4cb2-bcf7-4ad6a49ac4a5_ce4e1303-d4ee-421a-beb4-98117569ef32.html,,,,,, Isobutyl acetate,110-19-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/891482c4-db26-46ca-936a-943956a1f453/documents/IUC5-3ffae477-075b-4cb2-bcf7-4ad6a49ac4a5_ce4e1303-d4ee-421a-beb4-98117569ef32.html,,oral,LD50,"13,413 mg/kg bw",adverse effect observed, Isobutyl acetate,110-19-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/891482c4-db26-46ca-936a-943956a1f453/documents/IUC5-3ffae477-075b-4cb2-bcf7-4ad6a49ac4a5_ce4e1303-d4ee-421a-beb4-98117569ef32.html,,dermal,LD50,"17,400 mg/kg bw",adverse effect observed, Isobutyl acetate,110-19-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/891482c4-db26-46ca-936a-943956a1f453/documents/IUC5-3ffae477-075b-4cb2-bcf7-4ad6a49ac4a5_ce4e1303-d4ee-421a-beb4-98117569ef32.html,,inhalation,LC50,"30,000 mg/m3",adverse effect observed, Isobutyl isobutyrate,97-85-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10e69846-8b58-4ead-9de0-e6ec1d2a8b04/documents/8995cbf1-6e59-4af1-944a-8885cf8b0ba8_73c6e8ae-9171-4710-a363-59998a7a63d2.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"9,094 mg/m3",,rat Isobutyl isobutyrate,97-85-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10e69846-8b58-4ead-9de0-e6ec1d2a8b04/documents/0031f199-f09e-4154-85a5-abcf75cdf490_73c6e8ae-9171-4710-a363-59998a7a63d2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Isobutyl isobutyrate,97-85-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10e69846-8b58-4ead-9de0-e6ec1d2a8b04/documents/0031f199-f09e-4154-85a5-abcf75cdf490_73c6e8ae-9171-4710-a363-59998a7a63d2.html,,dermal,LD50,"10,000 mg/kg bw",no adverse effect observed, Isobutyl methacrylate,97-86-9,"There are no RDT experimental data available for i-BMA. Data requirements for systemic effects of i-BMA as parent ester were covered by read across to the acid metabolite donor, methyl methacrylat (MMA, CAS: 80-62-6), and the alcohol metabolite, iso-Butyl Alcohol (i-BuOH, CAS 79-41-4). Data requirements for local effects after repeated inhalation covered by read across to the structural analogous n-Butyl Methacrylate (n-BMA, CAS 97-88-1) that have comparable phys-chem properties.   Oral MMA, Borzelleca 1964:  chronic, drinking water, rat (pre-guideline): NOAEL 124/164 mg/kg/d in males/ females corresponding to NOAEL for iBMA of >= 176 mg/ kg bw/day (males) and >= 230 mg/kg bw/day (females) I-BuOH, Schilling, 1997: subchronic, drinking water, rat (OECD 408): NOAEL 1450 mg/kg bw/d, corresponding to a NOAEL (iBMA) of 2781 mg/kg bw/d for males and females   Inhalation-Systemic: MMA, NTP 1986: 2-year study, systemic NOAEC of 500 ppm for iBMA iBuOH, Li A, 1999: 90-day study, systemic NOEC is regarded as 1000 ppm and systemic NOAEC of 2500 ppm for iBMA.   Inhalation-Local: nBMA: Integrative assessment on 5 nBMA inhalation studies on rodents, NOAEC: 60 ppm   Key studies for DNEL calculation Oral-Long-term exposure: A 2-year repeat-dose oral (drinking water) exposure study with MMA in which the NOAEL was 164 mg MMA/kg bw/day, corresponding to 176 mg iBMA/kg bw/day (2,000 ppm in drinking water) (Borzelleca et al., 1964) was chosen for DNEL calculation representing the more conservative PoD in comparison to i-BuOH data. Inhalation-systemic effects: A 2-year inhalation study with MMA was chosen as the most appropriate starting point for the acidic moiety of IBMA, with a systemic NOAEC of 500 ppm (NTP 1986). Inhalation-local effects: NOAEC chronic: 60 ppm; target tissue: olfactory epithelium (integrative assessment of local effects identified in 5 guideline studes with nBMA) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d9c4d27-8752-42e4-9f43-c4c761beba77/documents/IUC5-d8561458-c5e3-44b9-b68f-7826406418a8_5bf55392-2d06-4ff9-b102-67a3e53073d6.html,,,,,, Isobutyl methacrylate,97-86-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d9c4d27-8752-42e4-9f43-c4c761beba77/documents/IUC5-d8561458-c5e3-44b9-b68f-7826406418a8_5bf55392-2d06-4ff9-b102-67a3e53073d6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,">= 1,450 mg/kg bw/day",,rat Isobutyl methacrylate,97-86-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d9c4d27-8752-42e4-9f43-c4c761beba77/documents/IUC5-d8561458-c5e3-44b9-b68f-7826406418a8_5bf55392-2d06-4ff9-b102-67a3e53073d6.html,Chronic toxicity – systemic effects,inhalation,NOAEC,>= 500 ,, Isobutyl methacrylate,97-86-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d9c4d27-8752-42e4-9f43-c4c761beba77/documents/IUC5-d8561458-c5e3-44b9-b68f-7826406418a8_5bf55392-2d06-4ff9-b102-67a3e53073d6.html,Repeated dose toxicity – local effects,inhalation,NOAEC,60 ,adverse effect observed, Isobutyl methacrylate,97-86-9,"Acute oral toxicity, rat, LD50=9590 mg/kg (Sterner and Stiglic, 1977)Acute dermal toxicity > 2000 mg/kg (read-across)Acute inhalation toxicity, LT50 290 min at 29.74 mg/L (Lawrence et al. 1974)   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d9c4d27-8752-42e4-9f43-c4c761beba77/documents/IUC5-f003255a-5ce8-46dd-a34d-64166301cef3_5bf55392-2d06-4ff9-b102-67a3e53073d6.html,,,,,, Isobutyl methacrylate,97-86-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d9c4d27-8752-42e4-9f43-c4c761beba77/documents/IUC5-f003255a-5ce8-46dd-a34d-64166301cef3_5bf55392-2d06-4ff9-b102-67a3e53073d6.html,,oral,LD50,"9,590 mg/kg bw",no adverse effect observed, Isobutyl methacrylate,97-86-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d9c4d27-8752-42e4-9f43-c4c761beba77/documents/IUC5-f003255a-5ce8-46dd-a34d-64166301cef3_5bf55392-2d06-4ff9-b102-67a3e53073d6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Isobutyl methacrylate,97-86-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d9c4d27-8752-42e4-9f43-c4c761beba77/documents/IUC5-f003255a-5ce8-46dd-a34d-64166301cef3_5bf55392-2d06-4ff9-b102-67a3e53073d6.html,,inhalation,LC50,"29,740 mg/m3",adverse effect observed, Isobutyl salicylate,87-19-4, The LD50 of the test item is 1310 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e293bc5c-c0b9-4c54-9044-863f65d03cb3/documents/d4cec4ea-278c-482f-9345-ea6c21daddc4_f0f84675-35c7-4f9a-81fd-63f13ea1b624.html,,,,,, Isobutyl salicylate,87-19-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e293bc5c-c0b9-4c54-9044-863f65d03cb3/documents/d4cec4ea-278c-482f-9345-ea6c21daddc4_f0f84675-35c7-4f9a-81fd-63f13ea1b624.html,,oral,LD50,"1,310 mg/kg bw",adverse effect observed, "N-[4-(2,4-dihydroxyphenyl)-1,3-thiazol-2-yl]-2-methylpropanamide",1428450-95-6," One study was performed to determine the acute oral toxicity of N-[4-(2,4-dihydroxyphenyl)-1,3-thiazol-2-yl]-2-methylpropanamide. There is no need to determine the acute toxicity via the dermal and the inhalation route. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7ee9484-0202-4cac-9c3f-f2c72171f380/documents/3c850b1c-54f9-48c3-a16d-50eae06327b3_e5ec80f1-3a77-4954-99b3-cc96783d7c55.html,,,,,, "N-[4-(2,4-dihydroxyphenyl)-1,3-thiazol-2-yl]-2-methylpropanamide",1428450-95-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7ee9484-0202-4cac-9c3f-f2c72171f380/documents/3c850b1c-54f9-48c3-a16d-50eae06327b3_e5ec80f1-3a77-4954-99b3-cc96783d7c55.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Triethoxyisobutylsilane,17980-47-1,"In a key 28-day repeated dose oral gavage study conducted using a protocol similar to OECD Test Guideline 407 and in compliance with GLP, the NOAEL for triethoxy(isobutyls)ilane (CAS 17980-47-1; EC 402-810-3) was at least 1000 mg/kg bw/day, based on no treatment related adverse toxicological findings at the limit dose (Huntingdon Research Centre, 1988, reliability 2).   In a key 90-day repeated nose-only inhalation study, conducted according to OECD Test Guideline 413 and in compliance with GLP, the NOAEC for triethoxy(isobutyl)silane was at least 2.54 mg/l in rats based on no treatment related adverse effects observed at any test concentration (SafePharm Laboratories, Ltd., 1992a, reliability 1). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f6d9577-4565-4aaf-a51f-fc4573eb7267/documents/bdd896a0-213e-4661-a0e9-15524397010b_faa7e0fb-a82d-476f-bd49-48e5b445e47a.html,,,,,, Triethoxyisobutylsilane,17980-47-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f6d9577-4565-4aaf-a51f-fc4573eb7267/documents/bdd896a0-213e-4661-a0e9-15524397010b_faa7e0fb-a82d-476f-bd49-48e5b445e47a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat Triethoxyisobutylsilane,17980-47-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f6d9577-4565-4aaf-a51f-fc4573eb7267/documents/bdd896a0-213e-4661-a0e9-15524397010b_faa7e0fb-a82d-476f-bd49-48e5b445e47a.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,">= 2,540 mg/m3",,rat Triethoxyisobutylsilane,17980-47-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f6d9577-4565-4aaf-a51f-fc4573eb7267/documents/bdd896a0-213e-4661-a0e9-15524397010b_faa7e0fb-a82d-476f-bd49-48e5b445e47a.html,Repeated dose toxicity – local effects,inhalation,NOAEC,">= 2,540 mg/m3",no adverse effect observed,rat Triethoxyisobutylsilane,17980-47-1,"In an acute oral toxicity study with triethoxy(isobutyl)silane (CAS 17980-47-1; EC 402-810-3), conducted according to a protocol comparable to the now deleted OECD Test Guideline 401 and in compliance with GLP, the LD₅₀ was concluded to be greater than 5000 mg/kg bw in rats (Huntingdon Research Centre Ltd., 1987a, reliability 1).   In an acute inhalation toxicity study with triethoxy(isobutyl)silane, conducted according to a protocol comparable to OECD Test Guideline 403 and in compliance with GLP, the LC₅₀ was concluded to be greater than 5.88 mg/L (Huntingdon Research Centre Ltd., 1990, reliability 1).   In an acute dermal toxicity with triethoxy(isobutyl)silane, conducted according to a protocol comparable to OECD Test Guideline 402 and in compliance with GLP, the LD₅₀ was concluded to be greater than 2000 mg/kg bw (Huntingdon Research Centre Ltd., 1987b, reliability 1). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f6d9577-4565-4aaf-a51f-fc4573eb7267/documents/8ad67613-4777-40fb-9692-41bb09c4819c_faa7e0fb-a82d-476f-bd49-48e5b445e47a.html,,,,,, Triethoxyisobutylsilane,17980-47-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f6d9577-4565-4aaf-a51f-fc4573eb7267/documents/8ad67613-4777-40fb-9692-41bb09c4819c_faa7e0fb-a82d-476f-bd49-48e5b445e47a.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Triethoxyisobutylsilane,17980-47-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f6d9577-4565-4aaf-a51f-fc4573eb7267/documents/8ad67613-4777-40fb-9692-41bb09c4819c_faa7e0fb-a82d-476f-bd49-48e5b445e47a.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Triethoxyisobutylsilane,17980-47-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f6d9577-4565-4aaf-a51f-fc4573eb7267/documents/8ad67613-4777-40fb-9692-41bb09c4819c_faa7e0fb-a82d-476f-bd49-48e5b445e47a.html,,inhalation,LC50,"> 5,880 mg/m3",no adverse effect observed, Isobutyric acid,79-31-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): sufficient for evaluation Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): sufficient for evaluation ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9056d01f-d361-4fd1-8935-1632acbb572f/documents/28ddec3d-d9ee-4caf-8094-03997274eccc_52984574-8be5-4507-a415-4c41eb10aea3.html,,,,,, Isobutyric acid,79-31-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9056d01f-d361-4fd1-8935-1632acbb572f/documents/28ddec3d-d9ee-4caf-8094-03997274eccc_52984574-8be5-4507-a415-4c41eb10aea3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,188 mg/kg bw/day",,rat Isobutyric acid,79-31-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9056d01f-d361-4fd1-8935-1632acbb572f/documents/28ddec3d-d9ee-4caf-8094-03997274eccc_52984574-8be5-4507-a415-4c41eb10aea3.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"9,150 mg/m3",,rat Isobutyric acid,79-31-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): qualified studiies available for assessment Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): qualified studies available for assessment Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): qualified studiy available for assessment ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9056d01f-d361-4fd1-8935-1632acbb572f/documents/c065acef-0435-4a98-ac27-f16da35033c2_52984574-8be5-4507-a415-4c41eb10aea3.html,,,,,, Isobutyric acid,79-31-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9056d01f-d361-4fd1-8935-1632acbb572f/documents/c065acef-0435-4a98-ac27-f16da35033c2_52984574-8be5-4507-a415-4c41eb10aea3.html,,oral,LD50,"2,230 mg/kg bw",adverse effect observed, Isobutyric acid,79-31-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9056d01f-d361-4fd1-8935-1632acbb572f/documents/c065acef-0435-4a98-ac27-f16da35033c2_52984574-8be5-4507-a415-4c41eb10aea3.html,,dermal,LD50,474 mg/kg bw,adverse effect observed, "4-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol",66068-84-6," Repeated dose toxicity: Oral The no observed adverse effect level (NOAEL) was considered to be 1125 mg/kg body weight/day for the test chemical when administered orally by gavage to male and female Sprague-Dawley rats. Repeated dose toxicity: Inhalation The repeated dose inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.00162 Pa (1.21509975e-5 mm Hg). Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely.  Therefore this study for repeated dose toxicity by inhalation route of exposure is considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value for 3-(2,3,3-trimethyl-6-bicyclo[2.2.1]heptanyl)cyclohexan-1-ol (CAS no 66068-84-6) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72582ebd-6f08-4a2b-a752-fd9dd9a524d4/documents/c14b7576-37a8-481f-922b-d49cf6dc9958_3816f9ec-e46e-4352-a6cf-20cd5795c925.html,,,,,, "4-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol",66068-84-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72582ebd-6f08-4a2b-a752-fd9dd9a524d4/documents/c14b7576-37a8-481f-922b-d49cf6dc9958_3816f9ec-e46e-4352-a6cf-20cd5795c925.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,125 mg/kg bw/day",,rat "4-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol",66068-84-6," Acute oral toxicity:  Acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the given test chemical. The LD50 value was considered to be >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  Acute Inhalation toxicity dose (LC50) was considered based on different studies conducted on rats for the test chemical. The LC50 value was considered to be >5.27 mg/L (>527000 mg/m3). The study concluded that the LC50 value is >5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute Inhalation toxicity. Acute Dermal toxicity:  The acute dermal toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72582ebd-6f08-4a2b-a752-fd9dd9a524d4/documents/f86d6076-e875-4cd0-8853-2a373665976a_3816f9ec-e46e-4352-a6cf-20cd5795c925.html,,,,,, "4-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol",66068-84-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72582ebd-6f08-4a2b-a752-fd9dd9a524d4/documents/f86d6076-e875-4cd0-8853-2a373665976a_3816f9ec-e46e-4352-a6cf-20cd5795c925.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol",66068-84-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72582ebd-6f08-4a2b-a752-fd9dd9a524d4/documents/f86d6076-e875-4cd0-8853-2a373665976a_3816f9ec-e46e-4352-a6cf-20cd5795c925.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-(5,5,6-trimethylbicyclo[2.2.1]hept-2-yl)cyclohexan-1-ol",66068-84-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72582ebd-6f08-4a2b-a752-fd9dd9a524d4/documents/f86d6076-e875-4cd0-8853-2a373665976a_3816f9ec-e46e-4352-a6cf-20cd5795c925.html,,inhalation,LC50,"527,000 mg/m3",no adverse effect observed, "2,4,6-trimethylcyclohex-3-ene-1-methanol",68527-77-5,Acute oral toxicity: OECD TG 423: > 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/522e974d-e741-46b2-ad28-0ba114581101/documents/b3feda0d-baac-406b-a732-0c1a691275d7_688f19e7-8375-4b76-bfa2-f5162504b841.html,,,,,, Isodecyl acrylate,1330-61-6,"A combined 28-Day Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test has been performed with Isodecyl Acrylate by Oral Gavage in Rats (following OECD TG 422). For females, clinical signs and mortality were observed from 300 mg/kg/day and were likely test item related. Mortality occured during premating and early lactation, and was accompanied with lower pups viability and mean pup weight. For males, a marked decrease in mean white blood cell count considered as test item-related occurred from 300 mg/kg/day and was considered adverse. A systemic No Observed Adverse Effect Level (NOAEL) of at least 100 mg/kg/day was therefore derived for males based on hematology findings. A systemic NOAEL of at least 100 mg/kg/day was derived for females based on a poor clinical condition considered to be associated with lower pup viability leading to total litter loss for a few females at higher doses. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9d78374-1bda-4ec8-8017-d55b84609b65/documents/IUC5-12d3f70d-6479-4b19-af88-2cb9ea20dab9_006fd0fc-014f-492c-bfa8-8414046595a4.html,,,,,, Isodecyl acrylate,1330-61-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9d78374-1bda-4ec8-8017-d55b84609b65/documents/IUC5-12d3f70d-6479-4b19-af88-2cb9ea20dab9_006fd0fc-014f-492c-bfa8-8414046595a4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Isodecyl acrylate,1330-61-6,"Based on the acute toxicity studies available, isodecyl acrylate shows a low toxicity after a single administration by oral or dermal route, in rats and rabbits respectively. The inhalation of a highly saturated vapour-air-mixture with isodecyl acrylate represents an unlikely acute hazard. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9d78374-1bda-4ec8-8017-d55b84609b65/documents/IUC5-e0e59ebe-8264-4d42-9907-92f69732a509_006fd0fc-014f-492c-bfa8-8414046595a4.html,,,,,, Isodecyl acrylate,1330-61-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9d78374-1bda-4ec8-8017-d55b84609b65/documents/IUC5-e0e59ebe-8264-4d42-9907-92f69732a509_006fd0fc-014f-492c-bfa8-8414046595a4.html,,oral,LD50,"9,486 mg/kg bw",no adverse effect observed, Isodecyl acrylate,1330-61-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9d78374-1bda-4ec8-8017-d55b84609b65/documents/IUC5-e0e59ebe-8264-4d42-9907-92f69732a509_006fd0fc-014f-492c-bfa8-8414046595a4.html,,dermal,LD50,"3,140 mg/kg bw",no adverse effect observed, Isodecyl acrylate,1330-61-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9d78374-1bda-4ec8-8017-d55b84609b65/documents/IUC5-e0e59ebe-8264-4d42-9907-92f69732a509_006fd0fc-014f-492c-bfa8-8414046595a4.html,,inhalation,discriminating conc.,333 mg/m3,no adverse effect observed, "Isodecyl 3,5,5-trimethylhexanoate",59231-35-5, Study performed to recognised testing guideline and GLP. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29606262-0079-47f9-bb52-94e7b154af21/documents/9d916ab0-29a6-4bf7-9422-d3255ccfaf56_cd5492c3-5152-4296-a02c-722c72bc6e77.html,,,,,, "Isodecyl 3,5,5-trimethylhexanoate",59231-35-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29606262-0079-47f9-bb52-94e7b154af21/documents/9d916ab0-29a6-4bf7-9422-d3255ccfaf56_cd5492c3-5152-4296-a02c-722c72bc6e77.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Isodecyl 3,5,5-trimethylhexanoate",59231-35-5, Studies performed in accordance with recognised testing guidelines. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29606262-0079-47f9-bb52-94e7b154af21/documents/d0e4b7d6-e871-40a3-b351-71831542455d_cd5492c3-5152-4296-a02c-722c72bc6e77.html,,,,,, Isodecyl oleate,59231-34-4,NOAEL systemic= 300 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfe330fd-44fd-4b78-805c-c2413d8ac726/documents/2e39287a-96d8-4244-a981-27df85842d8e_21b8134a-9e5d-40ba-8f94-43f4a14c07fe.html,,,,,, Isodecyl oleate,59231-34-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfe330fd-44fd-4b78-805c-c2413d8ac726/documents/2e39287a-96d8-4244-a981-27df85842d8e_21b8134a-9e5d-40ba-8f94-43f4a14c07fe.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Isodecyl oleate,59231-34-4,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfe330fd-44fd-4b78-805c-c2413d8ac726/documents/8c6b4589-e5f3-451e-b860-172cf083bd19_21b8134a-9e5d-40ba-8f94-43f4a14c07fe.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., triisobutylene fraction, hydrogenated",93685-81-5, Oral NOAEL (Rat): >1000 mg/Kg bw/day Inhalation NOAEC (Rat): ≥ 10400 mg/m3 ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6c60e74-47d9-493a-a726-b710fa334102/documents/9aaa0171-7c9d-483e-9920-b5ddffd81fe0_3d067bdf-b38b-4f8a-abd2-a8820ab8af44.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., triisobutylene fraction, hydrogenated",93685-81-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6c60e74-47d9-493a-a726-b710fa334102/documents/9aaa0171-7c9d-483e-9920-b5ddffd81fe0_3d067bdf-b38b-4f8a-abd2-a8820ab8af44.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hydrocarbons, C4, 1,3-butadiene-free, polymd., triisobutylene fraction, hydrogenated",93685-81-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6c60e74-47d9-493a-a726-b710fa334102/documents/9aaa0171-7c9d-483e-9920-b5ddffd81fe0_3d067bdf-b38b-4f8a-abd2-a8820ab8af44.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"10,400 mg/m3",,rat "Hydrocarbons, C4, 1,3-butadiene-free, polymd., triisobutylene fraction, hydrogenated",93685-81-5, Oral LD50 (rat) > 5000 mg/Kg bw Inhalation LC50 (rat) >5000 mg/m³ Dermal LD50 (rabbit) > 3.16 mL/Kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6c60e74-47d9-493a-a726-b710fa334102/documents/f17b3a22-12a1-4b8a-b9b3-a292a259b2c8_3d067bdf-b38b-4f8a-abd2-a8820ab8af44.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., triisobutylene fraction, hydrogenated",93685-81-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6c60e74-47d9-493a-a726-b710fa334102/documents/f17b3a22-12a1-4b8a-b9b3-a292a259b2c8_3d067bdf-b38b-4f8a-abd2-a8820ab8af44.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., triisobutylene fraction, hydrogenated",93685-81-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6c60e74-47d9-493a-a726-b710fa334102/documents/f17b3a22-12a1-4b8a-b9b3-a292a259b2c8_3d067bdf-b38b-4f8a-abd2-a8820ab8af44.html,,dermal,LD50,"> 2,200 mg/kg bw",no adverse effect observed, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., triisobutylene fraction, hydrogenated",93685-81-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6c60e74-47d9-493a-a726-b710fa334102/documents/f17b3a22-12a1-4b8a-b9b3-a292a259b2c8_3d067bdf-b38b-4f8a-abd2-a8820ab8af44.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "2,2,4,6,6-pentamethylheptane",13475-82-6, Oral NOAEL (Rat): >1000 mg/Kg bw/day Inhalation NOAEC (Rat): ≥ 10400 mg/m3 ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e595336d-e5fb-43f5-af45-4b09b82f0c06/documents/d1ae2212-7ebf-4bac-88a8-65cc4921d1e4_55168f46-8dfb-47fd-b3cb-99f3fa12a24b.html,,,,,, "2,2,4,6,6-pentamethylheptane",13475-82-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e595336d-e5fb-43f5-af45-4b09b82f0c06/documents/d1ae2212-7ebf-4bac-88a8-65cc4921d1e4_55168f46-8dfb-47fd-b3cb-99f3fa12a24b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2,4,6,6-pentamethylheptane",13475-82-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e595336d-e5fb-43f5-af45-4b09b82f0c06/documents/d1ae2212-7ebf-4bac-88a8-65cc4921d1e4_55168f46-8dfb-47fd-b3cb-99f3fa12a24b.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"10,400 mg/m3",,rat "2,2,4,6,6-pentamethylheptane",13475-82-6, Oral LD50 (rat) > 5000 mg/Kg bw Inhalation LC50 (rat) >5000 mg/m³ Dermal LD50 (rabbit) > 3.16 mL/Kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e595336d-e5fb-43f5-af45-4b09b82f0c06/documents/d2c990d1-9c58-45ab-822d-85b51f0dcbb9_55168f46-8dfb-47fd-b3cb-99f3fa12a24b.html,,,,,, "2,2,4,6,6-pentamethylheptane",13475-82-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e595336d-e5fb-43f5-af45-4b09b82f0c06/documents/d2c990d1-9c58-45ab-822d-85b51f0dcbb9_55168f46-8dfb-47fd-b3cb-99f3fa12a24b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,2,4,6,6-pentamethylheptane",13475-82-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e595336d-e5fb-43f5-af45-4b09b82f0c06/documents/d2c990d1-9c58-45ab-822d-85b51f0dcbb9_55168f46-8dfb-47fd-b3cb-99f3fa12a24b.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., pentaisobutylene fraction, hydrogenated",93685-79-1," Oral NOAEL (Rat): >1000 mg/Kg bw/day, based on weight of evidence from read across studies on structural analogues.   Inhalation NOAEC (Rat): > 1160 mg/m3, based on weight of evidence from read across studies on structural analogues. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5c050d4-1266-408d-aeb5-a6f9e04a8da8/documents/75bce056-edda-4872-9642-bce74e3752b4_37feed03-fc50-46ef-bdc2-afd3bc7e237a.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., pentaisobutylene fraction, hydrogenated",93685-79-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5c050d4-1266-408d-aeb5-a6f9e04a8da8/documents/75bce056-edda-4872-9642-bce74e3752b4_37feed03-fc50-46ef-bdc2-afd3bc7e237a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat "Hydrocarbons, C4, 1,3-butadiene-free, polymd., pentaisobutylene fraction, hydrogenated",93685-79-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5c050d4-1266-408d-aeb5-a6f9e04a8da8/documents/75bce056-edda-4872-9642-bce74e3752b4_37feed03-fc50-46ef-bdc2-afd3bc7e237a.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,160 mg/m3",,rat "Hydrocarbons, C4, 1,3-butadiene-free, polymd., pentaisobutylene fraction, hydrogenated",93685-79-1," For acute oral, dermal and inhalation toxicity studies, no mortality was observed at the highest doses tested, i. e. doses equal to or greater than 46.4 mL/Kg bw, 2000 mg/Kg bw and 5000 mg/m3, respectively. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5c050d4-1266-408d-aeb5-a6f9e04a8da8/documents/04651432-8154-4183-adce-1694935f375a_37feed03-fc50-46ef-bdc2-afd3bc7e237a.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., pentaisobutylene fraction, hydrogenated",93685-79-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5c050d4-1266-408d-aeb5-a6f9e04a8da8/documents/04651432-8154-4183-adce-1694935f375a_37feed03-fc50-46ef-bdc2-afd3bc7e237a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., pentaisobutylene fraction, hydrogenated",93685-79-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5c050d4-1266-408d-aeb5-a6f9e04a8da8/documents/04651432-8154-4183-adce-1694935f375a_37feed03-fc50-46ef-bdc2-afd3bc7e237a.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "2,2,4,4,6,8,8-heptamethylnonane",4390-04-9, Repeated Dose Oral 90d - NOAEL ≥ 500 mg/Kg bw/day for rats (OECD 408); BMDL = 1857 mg/Kg bw/day.   Repeated Dose Inhalation 90d – NOAEC ≥ 6000 mg/m3 for rats (similar to OECD TG 413) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a139af66-b549-407b-92a2-173ff4cece50/documents/f20dfdd3-e6c8-4546-93ad-60028f661749_37be8594-8a7f-45c9-a78f-86d1d10fde24.html,,,,,, "2,2,4,4,6,8,8-heptamethylnonane",4390-04-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a139af66-b549-407b-92a2-173ff4cece50/documents/f20dfdd3-e6c8-4546-93ad-60028f661749_37be8594-8a7f-45c9-a78f-86d1d10fde24.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "2,2,4,4,6,8,8-heptamethylnonane",4390-04-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a139af66-b549-407b-92a2-173ff4cece50/documents/f20dfdd3-e6c8-4546-93ad-60028f661749_37be8594-8a7f-45c9-a78f-86d1d10fde24.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"6,000 mg/m3",,rat "2,2,4,4,6,8,8-heptamethylnonane",4390-04-9, Oral LD50 (rat) > 5000 mg/Kg bw Inhalation LC50 (rat) >5991 mg/m³ Dermal LD50 (rabbit) > 2000 mg/Kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a139af66-b549-407b-92a2-173ff4cece50/documents/fe8e6700-49d9-40d8-a5f0-51ae35faf030_37be8594-8a7f-45c9-a78f-86d1d10fde24.html,,,,,, "2,2,4,4,6,8,8-heptamethylnonane",4390-04-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a139af66-b549-407b-92a2-173ff4cece50/documents/fe8e6700-49d9-40d8-a5f0-51ae35faf030_37be8594-8a7f-45c9-a78f-86d1d10fde24.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "2,2,4,4,6,8,8-heptamethylnonane",4390-04-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a139af66-b549-407b-92a2-173ff4cece50/documents/fe8e6700-49d9-40d8-a5f0-51ae35faf030_37be8594-8a7f-45c9-a78f-86d1d10fde24.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,2,4,4,6,8,8-heptamethylnonane",4390-04-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a139af66-b549-407b-92a2-173ff4cece50/documents/fe8e6700-49d9-40d8-a5f0-51ae35faf030_37be8594-8a7f-45c9-a78f-86d1d10fde24.html,,inhalation,LC50,"> 5,991 mg/m3",no adverse effect observed, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., tetraisobutylene fraction, hydrogenated",93685-80-4, Oral NOAEL (Rat): >1000 mg/Kg bw/day Inhalation NOAEC (Rat): ≥ 10400 mg/m3 ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d00f424f-1a11-406d-8e45-258ce39d8ae0/documents/f7221cd1-989a-4570-81f8-6162c80dbd8b_4f6eb285-fe68-448d-9723-762e14d4a9b6.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., tetraisobutylene fraction, hydrogenated",93685-80-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d00f424f-1a11-406d-8e45-258ce39d8ae0/documents/f7221cd1-989a-4570-81f8-6162c80dbd8b_4f6eb285-fe68-448d-9723-762e14d4a9b6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hydrocarbons, C4, 1,3-butadiene-free, polymd., tetraisobutylene fraction, hydrogenated",93685-80-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d00f424f-1a11-406d-8e45-258ce39d8ae0/documents/f7221cd1-989a-4570-81f8-6162c80dbd8b_4f6eb285-fe68-448d-9723-762e14d4a9b6.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"10,400 mg/m3",,rat "Hydrocarbons, C4, 1,3-butadiene-free, polymd., tetraisobutylene fraction, hydrogenated",93685-80-4,"For acute oral and dermal toxicity studies, no mortality was observed at the highest doses tested, i. e. doses equal to or greater than 5000 mg/kg bw and 2000 mg/kg bw, respectively. For acute inhalation, the LC50 was 1.85 mg/L air in males, 1.68 mg/L air for females and 1.73 mg/L air for both sexes. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d00f424f-1a11-406d-8e45-258ce39d8ae0/documents/IUC5-2104f99c-bf19-4fab-beeb-de3321242bac_4f6eb285-fe68-448d-9723-762e14d4a9b6.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., tetraisobutylene fraction, hydrogenated",93685-80-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d00f424f-1a11-406d-8e45-258ce39d8ae0/documents/IUC5-2104f99c-bf19-4fab-beeb-de3321242bac_4f6eb285-fe68-448d-9723-762e14d4a9b6.html,,oral,LD50,"5,000 mg/kg bw",, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., tetraisobutylene fraction, hydrogenated",93685-80-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d00f424f-1a11-406d-8e45-258ce39d8ae0/documents/IUC5-2104f99c-bf19-4fab-beeb-de3321242bac_4f6eb285-fe68-448d-9723-762e14d4a9b6.html,,dermal,LD50,"2,000 mg/kg bw",, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., tetraisobutylene fraction, hydrogenated",93685-80-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d00f424f-1a11-406d-8e45-258ce39d8ae0/documents/IUC5-2104f99c-bf19-4fab-beeb-de3321242bac_4f6eb285-fe68-448d-9723-762e14d4a9b6.html,,inhalation,LC50,"1,730 mg/m3",, L-isoleucine,73-32-5,"The NOAEL determined for L-isoleucine is ca. 600 mg/kg bw/d based on an observed increased maximum estrus cycle length at higher doses. As this is the only effect observed in the available repeated dose studies, and this was only observed at very high concentrations, it is reasonable to assume that the NOAEL is in reality above 1,000 mg/kg bw/day. However, based on the precautionary principle the NOAEL of 600 mg/kg bw/day is used as a starting point for the DNEL derivation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9448f4cf-626a-4baa-91c8-abbf438edbdf/documents/90203b90-3244-4f21-aae4-f72e9211152f_070b2e10-abc2-41ad-85a6-5ec019979b99.html,,,,,, L-isoleucine,73-32-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9448f4cf-626a-4baa-91c8-abbf438edbdf/documents/90203b90-3244-4f21-aae4-f72e9211152f_070b2e10-abc2-41ad-85a6-5ec019979b99.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,ca.600 mg/kg bw/day,,rat L-isoleucine,73-32-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9448f4cf-626a-4baa-91c8-abbf438edbdf/documents/a7a528ec-b6ec-471d-b99e-28cca782696f_070b2e10-abc2-41ad-85a6-5ec019979b99.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, L-isoleucine,73-32-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9448f4cf-626a-4baa-91c8-abbf438edbdf/documents/a7a528ec-b6ec-471d-b99e-28cca782696f_070b2e10-abc2-41ad-85a6-5ec019979b99.html,,inhalation,LC50,"> 5,410 mg/m3",no adverse effect observed, "1,3,4,6,7,8a-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one",23787-90-8,The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cdc757cd-0789-4cdb-be4c-6f0210d95e7b/documents/IUC5-b785971f-3a80-4ef7-ab87-69fbc1b2bdf2_53922ca4-3950-40d9-9bfe-ad5c588879c4.html,,,,,, "1,3,4,6,7,8a-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one",23787-90-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cdc757cd-0789-4cdb-be4c-6f0210d95e7b/documents/IUC5-b785971f-3a80-4ef7-ab87-69fbc1b2bdf2_53922ca4-3950-40d9-9bfe-ad5c588879c4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(2α,4aα,8α)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one",29461-14-1, The median lethal dose was LD50 ≥ 2000 mg/kg bw. The test substance does not need to be classified for acute oral toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0405405-685a-43fb-a291-8a155de0c439/documents/537c35f5-2ce1-448d-8914-24b7460e0b94_5e6bfadd-f738-4731-b09a-404e8922245d.html,,,,,, "(2α,4aα,8α)-hexahydro-1,1,5,5-tetramethyl-2H-2,4a-methanonaphthalen-8(5H)-one",29461-14-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0405405-685a-43fb-a291-8a155de0c439/documents/537c35f5-2ce1-448d-8914-24b7460e0b94_5e6bfadd-f738-4731-b09a-404e8922245d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol,64519-82-0," subchronic toxicity: OECD 408, oral (feeding) rat, 90 days: NOAEL 100 000 ppm (equivalent to ca. 7000 mg/kg bw/day in males and ca. 8400 mg/kg bw/day in females) Similar to OECD 409, oral (feeding) dog, 90 days: NOAEL 200 000 ppm (equivalent to ca. 6400 mg/kg bw/day in males and ca. 6000 mg/kg bw/day in females) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60069a30-09a7-4fd2-9b12-fe7b92e1bb58/documents/eb992e8e-b229-49ba-813f-6a56041c994d_e409d7aa-8860-42b3-978d-6ee20c43f86b.html,,,,,, Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol,64519-82-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60069a30-09a7-4fd2-9b12-fe7b92e1bb58/documents/eb992e8e-b229-49ba-813f-6a56041c994d_e409d7aa-8860-42b3-978d-6ee20c43f86b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"7,000 mg/kg bw/day",,rat Reaction mass of 1-O-α-D-glucopyranosyl-D-mannitol and 6-O-α-D-glucopyranosyl-D-glucitol,64519-82-0, Taking into account all available information the substance is considered to have no acute oral toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60069a30-09a7-4fd2-9b12-fe7b92e1bb58/documents/9b4c2718-f521-45e9-9134-fe5dfe1b8173_e409d7aa-8860-42b3-978d-6ee20c43f86b.html,,,,,, Isonicotinamide,1453-82-3, LD50 (orl rat) > 875 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc6b23b3-8a83-46bb-bff1-dd1e2794b3d5/documents/03ed5a31-c36a-4e36-b1db-fd715908ad72_91c2779d-80c1-432f-abad-4f8a8b3190e5.html,,,,,, Isononyl acetate,40379-24-6," Acute oral toxicity:  LD50 was estimated to be 6749.5 mg/kg bw when Wistar rats were orally exposed with 7-methyloctyl acetate. Acute Inhalation toxicity:  LC50 was estimated to be 61.4 mg/L air (61400 mg/m3), when rat was exposed to 7-methyloctyl acetate for 4 hr. Acute Dermal toxicity:  LD50 was estimated to be 6847 mg/kg bw when rabbits were treated with 7-methyloctyl acetate by dermal application. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3f39b6a-2f25-4bf8-9367-1c50655fd99b/documents/e0a7851d-9b35-43ce-8b90-46d0a42147e0_e871445a-28a9-41e6-a48f-099457ef74a0.html,,,,,, Isononyl acetate,40379-24-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3f39b6a-2f25-4bf8-9367-1c50655fd99b/documents/e0a7851d-9b35-43ce-8b90-46d0a42147e0_e871445a-28a9-41e6-a48f-099457ef74a0.html,,oral,LD50,"6,749.5 mg/kg bw",no adverse effect observed, Isononyl acetate,40379-24-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3f39b6a-2f25-4bf8-9367-1c50655fd99b/documents/e0a7851d-9b35-43ce-8b90-46d0a42147e0_e871445a-28a9-41e6-a48f-099457ef74a0.html,,dermal,LD50,"6,847 mg/kg bw",no adverse effect observed, Isononyl acetate,40379-24-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3f39b6a-2f25-4bf8-9367-1c50655fd99b/documents/e0a7851d-9b35-43ce-8b90-46d0a42147e0_e871445a-28a9-41e6-a48f-099457ef74a0.html,,inhalation,LC50,"61,400 mg/m3",no adverse effect observed, Isononyl alcohol,27458-94-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60c4712e-c601-4195-b51f-6ffebeddbb1c/documents/IUC5-d0cea745-d11d-426f-8385-044dc604d6c3_3aab2d55-4622-4ffe-833d-4699bdab1520.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,144 mg/kg bw/day,, Isononyl alcohol,27458-94-2,"Low acute oral, dermal and inhalation toxicity, based on test data for the material. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60c4712e-c601-4195-b51f-6ffebeddbb1c/documents/IUC5-60e9f66e-1a6d-4f82-9fb8-9ba60fb4ba86_3aab2d55-4622-4ffe-833d-4699bdab1520.html,,,,,, "3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate",59219-71-5,"The test item, isononyl isononanoate when administered daily for 13 weeks in SD rats induced premature mortality and/or severe illness status (hunched posture, decreased activity, piloerection, semi-closed eyes) associated with body weight and food consumption reduction in the females dosed at 350 mg/kg/day. Liver, kidneys and glandular region of the stomachwere affected in the early deceased animals. The surviving animals showed swollen abdomen, generally during the last weeks of treatment with a major incidence noted in females. Changes at clinical chemistry analysis (liver/metabolic parameters) and treatment-related macroscopic and/or microscopic findings in liver and kidneys were observed in animals dosed at ≥150 mg/kg/day. After 4-week recovery period, the reported changes showed a fully or almost complete reversibility. The above effects, although almost completely reversible at the end of recovery, were cause of poor health conditions of some female animals dosed at 350 mg/kg/day that lead to humane sacrifice or death. Therefore, they were considered to be adverse at this dose level.Treatment-related findings observed in animals dosed at 150 mg/kg/day were not of suchseverity to be considered adverse.On the basis of the above results, since the highest dose of 350 mg/kg/day induced toxicity including mortality, directly affecting stomach, kidneys and liver, it can be concluded that 150 mg/kg/day in the rat is the NOAEL (No Observed Adverse Effect Level) of isononyl isononanoate in the Sprague Dawley rats under the experimental conditions of the present study ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45529386-3fdc-404a-bc3a-528f248d5652/documents/IUC5-e0d2d0d3-cbc8-4f29-afa7-ff3c6a83b1f0_c9e121b7-ee12-4a01-aa35-343cd75d136c.html,,,,,, "3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate",59219-71-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45529386-3fdc-404a-bc3a-528f248d5652/documents/IUC5-e0d2d0d3-cbc8-4f29-afa7-ff3c6a83b1f0_c9e121b7-ee12-4a01-aa35-343cd75d136c.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,300 mg/kg bw/day,,rat "3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate",59219-71-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45529386-3fdc-404a-bc3a-528f248d5652/documents/IUC5-e0d2d0d3-cbc8-4f29-afa7-ff3c6a83b1f0_c9e121b7-ee12-4a01-aa35-343cd75d136c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate",59219-71-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45529386-3fdc-404a-bc3a-528f248d5652/documents/IUC5-e0d2d0d3-cbc8-4f29-afa7-ff3c6a83b1f0_c9e121b7-ee12-4a01-aa35-343cd75d136c.html,Repeated dose toxicity – local effects,dermal,NOAEL,1.76 mg/cm2,adverse effect observed,rat "3,5,5-trimethylhexyl 3,5,5-trimethylhexanoate",59219-71-5,Oral: LD50 > 4350 mg/kg bw Inhalation: LC50 > 5.7 mg/LDermal: LD50 > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45529386-3fdc-404a-bc3a-528f248d5652/documents/IUC5-0b749be0-0ac6-4cbb-884f-bfbc4db5a2f0_c9e121b7-ee12-4a01-aa35-343cd75d136c.html,,,,,, "2,2,4-trimethylpentane",540-84-1, Sub-chronic Repeated Dose Inhalation – NOAEC = 24300 mg/m3 for rats (similar to OECD TG 413) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86af0def-dc92-409f-89e3-56070a912fc0/documents/7734cd6b-f297-47b6-aa41-c1dc41a26997_4dcc4de4-0f53-4d9e-b969-705eaa21e6b2.html,,,,,, "2,2,4-trimethylpentane",540-84-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86af0def-dc92-409f-89e3-56070a912fc0/documents/7734cd6b-f297-47b6-aa41-c1dc41a26997_4dcc4de4-0f53-4d9e-b969-705eaa21e6b2.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"24,300 mg/m3",,rat "2,2,4-trimethylpentane",540-84-1, Acute toxicity oral LD50 >5000 mg/kg bw in rats (OECD TG 401) Acute toxicity dermal LD50 >2000 mg/kg bw in rabbits (OECD TG 402) Acute toxicity inhalation LC50 >33520 mg/m³ in rats (OECD TG 403) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86af0def-dc92-409f-89e3-56070a912fc0/documents/f09e347e-91d2-4ca9-851b-969b386b4c05_4dcc4de4-0f53-4d9e-b969-705eaa21e6b2.html,,,,,, "2,2,4-trimethylpentane",540-84-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86af0def-dc92-409f-89e3-56070a912fc0/documents/f09e347e-91d2-4ca9-851b-969b386b4c05_4dcc4de4-0f53-4d9e-b969-705eaa21e6b2.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "2,2,4-trimethylpentane",540-84-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86af0def-dc92-409f-89e3-56070a912fc0/documents/f09e347e-91d2-4ca9-851b-969b386b4c05_4dcc4de4-0f53-4d9e-b969-705eaa21e6b2.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,2,4-trimethylpentane",540-84-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86af0def-dc92-409f-89e3-56070a912fc0/documents/f09e347e-91d2-4ca9-851b-969b386b4c05_4dcc4de4-0f53-4d9e-b969-705eaa21e6b2.html,,inhalation,LC50,"> 33,520 mg/m3",no adverse effect observed, Isooctyl mercaptoacetate,25103-09-7,"No repeated dose toxicity studyies are available for IOTG. The administration of up to 0.2% 2-ethyl hexyl thioglycolate, a structural analogue, in the diet of rats for 28 days did not lead to a proliferation of hepatic peroxisomes, and did not produce any treatment-related effects. The 28 day NOAEL was 0.2% EHTG in the diet (the highest dose tested; 168 mg/kg bw for males; 173 mg/kg bw for females). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3db3bce-850d-405e-9486-b046c02e589b/documents/74399b82-cebb-4817-b9c6-49627c5db090_89bc64aa-b8fb-4f1c-9e03-105bdd28c8e1.html,,,,,, Isooctyl mercaptoacetate,25103-09-7,"An acute toxicity study has been conducted with 2-ethylhexyl thioglycolate, a structural analogue of IOTG, by the oral route (Schmidt et al, 1974). The acute oral toxicity value indicate moderate toxicity, with LD50 value in rats of 303 – 334 mg/kg bw. Acute dermal and inhalation toxicity of IOTG is low, with 7-hour inhalation LC0 values in rats higher than 0.36 mg/L air (vapours generated at room temperature) or > 14.3 mg/L air (vapours generated at 135°C) (Rampy, 1973) and a dermal LD0 in rats greater than 2000 mg/kg bw (Clouzeau, 1993). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3db3bce-850d-405e-9486-b046c02e589b/documents/fff7f192-cf62-4c05-852f-997fb5684b30_89bc64aa-b8fb-4f1c-9e03-105bdd28c8e1.html,,,,,, Isooctyl mercaptoacetate,25103-09-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3db3bce-850d-405e-9486-b046c02e589b/documents/fff7f192-cf62-4c05-852f-997fb5684b30_89bc64aa-b8fb-4f1c-9e03-105bdd28c8e1.html,,oral,LD50,303 mg/kg bw,, Isooctyl mercaptoacetate,25103-09-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3db3bce-850d-405e-9486-b046c02e589b/documents/fff7f192-cf62-4c05-852f-997fb5684b30_89bc64aa-b8fb-4f1c-9e03-105bdd28c8e1.html,,dermal,discriminating dose,"2,000 mg/kg bw",, Isooctyl mercaptoacetate,25103-09-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3db3bce-850d-405e-9486-b046c02e589b/documents/fff7f192-cf62-4c05-852f-997fb5684b30_89bc64aa-b8fb-4f1c-9e03-105bdd28c8e1.html,,inhalation,discriminating conc.,360 mg/m3,, Isovaleraldehyde,590-86-3,"The oral LD50 of isovaleraldehyde was determined to be 5740 mg/kg bw in male and female rats (BASF, 1974).The inhalation LC50 of isovaleraldehyde was determined to be 42.7 mg/L in rats (Carpenter, 1974).The dermal LD50 of isovaleraldehyde was determined to be 2534 mg/kg bw in male rabbits (Carpenter, 1974). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fe23e50-ab81-443f-b264-5d771d1bada6/documents/3d8af1d7-7756-4d64-943e-e8232eb55d22_24fae16f-c6ef-426c-8ee3-8ac26d093914.html,,,,,, Isovaleraldehyde,590-86-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fe23e50-ab81-443f-b264-5d771d1bada6/documents/3d8af1d7-7756-4d64-943e-e8232eb55d22_24fae16f-c6ef-426c-8ee3-8ac26d093914.html,,oral,LD50,"5,740 mg/kg bw",adverse effect observed, Isovaleraldehyde,590-86-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fe23e50-ab81-443f-b264-5d771d1bada6/documents/3d8af1d7-7756-4d64-943e-e8232eb55d22_24fae16f-c6ef-426c-8ee3-8ac26d093914.html,,dermal,LD50,"2,534 mg/kg bw",adverse effect observed, Isovaleraldehyde,590-86-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fe23e50-ab81-443f-b264-5d771d1bada6/documents/3d8af1d7-7756-4d64-943e-e8232eb55d22_24fae16f-c6ef-426c-8ee3-8ac26d093914.html,,inhalation,LC50,42.7 mg/m3,adverse effect observed, 2-methylbutane,78-78-4, Inhalation NOAEC (Rat): 20000 mg/m3 (according to OECD TG 413) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9af3a2f-0529-4cbb-a48c-908604d90306/documents/ecd78553-37a0-4a78-adc5-fb6c3b10c3b4_adb3680a-c1a6-4f85-8fd4-ef87d1336924.html,,,,,, 2-methylbutane,78-78-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9af3a2f-0529-4cbb-a48c-908604d90306/documents/ecd78553-37a0-4a78-adc5-fb6c3b10c3b4_adb3680a-c1a6-4f85-8fd4-ef87d1336924.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"20,000 mg/m3",,rat 2-methylbutane,78-78-4, Acute Toxicity - Oral LD50 > 2000 mg/Kg in rats (OECD TG 401) Acute Toxicity - Inhalation LC50 > 25300 mg/m3 (OECD TG 403) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9af3a2f-0529-4cbb-a48c-908604d90306/documents/b4300c90-99ac-4b22-b3ed-c00386acb642_adb3680a-c1a6-4f85-8fd4-ef87d1336924.html,,,,,, 2-methylbutane,78-78-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9af3a2f-0529-4cbb-a48c-908604d90306/documents/b4300c90-99ac-4b22-b3ed-c00386acb642_adb3680a-c1a6-4f85-8fd4-ef87d1336924.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-methylbutane,78-78-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9af3a2f-0529-4cbb-a48c-908604d90306/documents/b4300c90-99ac-4b22-b3ed-c00386acb642_adb3680a-c1a6-4f85-8fd4-ef87d1336924.html,,inhalation,LC50,"> 25,300 mg/m3",no adverse effect observed, 2-tert-pentylcyclohexyl acetate,67874-72-0," For Coniferan the repeated dose toxicity information is derived using information from the close analogue Verdox and with support of another analogue Cyclacet being tested in an OECD TG 408 study Verdox tested in a study similar to OECD TG 408 (extended to 10 weeks OECD TG 422): No adverse effect observed, NOAEL ≥437 mg/kg bw for males and females. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/047f9dd9-e528-4aaf-8a86-32e068a53b50/documents/IUC5-725ab068-b53b-4df2-9844-8782894ab2d3_218f2535-1367-435e-943d-670aa22af85f.html,,,,,, 2-tert-pentylcyclohexyl acetate,67874-72-0, Acute rat oral toxicity in a similar to OECD TG 401 study: LD50 >= 5000 mg/kg bw Acute rabbit dermal toxicity: similar to OECD TG 402: LD50 > 5000 mg/kg bw Acute inhalation information using route to route extrapolation: LC50 > 13000 mg/m3 ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/047f9dd9-e528-4aaf-8a86-32e068a53b50/documents/IUC5-6744af14-3b05-4185-9fda-3ed6f6f93984_218f2535-1367-435e-943d-670aa22af85f.html,,,,,, 4-tert-pentylcyclohexanone,16587-71-6," Orivone systemic toxicity is derived from the analogue trans-4-tert-butyl cyclohexanol for which an oral gavage OECD TG 408 study was performed: NOAEL = 240 mg/kg bw/ day and a LOAEL at 800 mg/kg bw. The systemic toxicity in an OECD TG 414 study with the analogue 4 -tert-butylcyclohexyl acetate (similar to OECD TG 414), with a NOAEL of 160 and a LOAEL 640 mg/kg bw, is derived. The type of effects seen in the OECD TG 414 clinical signs, such as (excess) salivation quite severe decreases in body weight and food consumption are also seen in the OECD TG 408 study and indicate a similar mode of action. The sacrificed dam / 25 dams on day 20 of the OECD TG 414 study, can be the result of low body weight and being pregnant. This dam showed a similar pattern of body weight up to day 18 as other dams in this high dose group. At day 19 and 20 this dam had the lowest body weight, therefore the body weight decrease may be crucial here. Taking the decreased body weight as a key indicator for repeated dose toxicity we can assume that in absence of such body weight loss mortality will not occur either. Therefor the derived NOAEL from the OECD TG 414 study can be used as a starting point for sub-chronic repeated exposure because the exposure and effects during pregnancy are also covered. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2cabfb7-890d-42a5-b160-a3f1d3a25106/documents/4ff379d3-a6b3-4ebf-97bd-a12b684fc266_4a71cb03-40ed-4ce2-98db-815fcb786d14.html,,,,,, 4-tert-pentylcyclohexanone,16587-71-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2cabfb7-890d-42a5-b160-a3f1d3a25106/documents/4ff379d3-a6b3-4ebf-97bd-a12b684fc266_4a71cb03-40ed-4ce2-98db-815fcb786d14.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,136 mg/kg bw/day,,rat 4-tert-pentylcyclohexanone,16587-71-6, Acute oral toxicity: a study similar to OECDTG401: LD50 = 4700 mg/kg bw Acute inhalation toxicity LC50 route to route extrapolation = 12200 mg/m3 Acute dermal toxicity: a study similar to OECDTG402: LD50 = 4700 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2cabfb7-890d-42a5-b160-a3f1d3a25106/documents/978d5121-e76b-4bac-97ef-152569172e3c_4a71cb03-40ed-4ce2-98db-815fcb786d14.html,,,,,, "3-aminomethyl-3,5,5-trimethylcyclohexylamine",2855-13-2,"In a subchronic drinking water study according to OECD TG 408 with rats, the administration of 150 mg/kg bw/day led to reduced absolute and relative kidney weights in male and female rats (histopathology being indicative for tubular nephrosis), while 59 mg/kg bw/day (males) and 62 mg/kg bw/day (females) were determined as a NOAEL (RCC 1986).     In a dose range finding study for an OECD 422 study (LPT 2020), rats showed some clinical signs such as salivation and breathing sounds in the highest dose group of 500/350 mg/kg bw. Because one male animal died in first week, the highest dose was reduced from 500 to 350 mg/kg bw/d.There was a significantly reduced food consumption in both (high) dose groups, which lead to significantly reduced body weight in the first week of application. As the food consumption recovered during the second test week, the reductions that were noted during the first test week are not considered to be of toxicological relevance. Necropsy revealed test item related gastrointestinal changes for some male and female animals of the high dose group (500/350 mg /kg b.w./day). Based on the results the following dose levels are recommended for the OECD 422 study: 30 mg/ kg/b.w./day (low dose), 100 mg/ kg/b.w./day (intermediate dose), 300 mg/ kg/b.w./day (high dose). The aim of the subsequently performed study was to obtain information on possible effects of the test item on general toxicity, reproduction and/or development according to OECD guideline 422. The test item was administered orally to rats at dose levels of 30, 100 or 300 mg/kg b.w./day. Due to mortality, the high dose level was decreased to 240 mg/kg b.w./day, starting on test day 28.Additionally, this OECD 422 serves as dose range finding study for the OECD 443 study. The NOAEL for general toxicity is considered to be 100 mg/ kg bw/day (Provivo, 2022) From two 14-day inhalative exposure studies with rats no NOAEL could be determined. At the first study’s LOAEL of 18 mg/m3, degeneration/necrosis in the olfactory epithelium of the nose were observed. Trachea, larynx and lungs were affected at 200 mg/m3 and above (degeneration/ necrosis, hyperplasia, squamous metaplasia) (DuPont, 1997). At the LOAEL of the follow-up study, i.e. at 2.2 mg/m³, reversible minimal to mild degeneration of respiratory nasal mucosa in the anterior dorsal nose was observed (DuPont, 2001).  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): The study is reliable with restrictions (Klimisch 2) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The study is reliable with restrictions (Klimisch 2) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study is reliable without restrictions (Klimisch 1) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0aa1e82-e077-4783-b63a-d954475485e3/documents/IUC5-a692485e-062f-466d-8edb-e74dea5988c0_b4386327-3a77-435f-adb6-446537d744fa.html,,,,,, "3-aminomethyl-3,5,5-trimethylcyclohexylamine",2855-13-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0aa1e82-e077-4783-b63a-d954475485e3/documents/IUC5-a692485e-062f-466d-8edb-e74dea5988c0_b4386327-3a77-435f-adb6-446537d744fa.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,59 mg/kg bw/day,,rat "3-aminomethyl-3,5,5-trimethylcyclohexylamine",2855-13-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0aa1e82-e077-4783-b63a-d954475485e3/documents/IUC5-a692485e-062f-466d-8edb-e74dea5988c0_b4386327-3a77-435f-adb6-446537d744fa.html,Repeated dose toxicity – local effects,inhalation,LOAEC,2.2 mg/m3,adverse effect observed,rat "3-aminomethyl-3,5,5-trimethylcyclohexylamine",2855-13-2, The LD50 after oral application to male rats is 1030 mg/kg bw and the kidney is the potential target organ (Klimmer 1965). Acute inhalation toxicity: The LC50 after inhalation was determined in male rats (LC50 1.07-5.01 mg/L) and in female rats (LC50 > 5.01 mg/L) resulting in a LC50 of > 5.01 mg/L for both sexes (CR 2011). Acute dermal toxicity: The LD50 after dermal exposure is > 2000 mg/kg bw in rats (Moon 2010). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0aa1e82-e077-4783-b63a-d954475485e3/documents/IUC5-c105f4d0-81c0-4902-9076-162a426fd4db_b4386327-3a77-435f-adb6-446537d744fa.html,,,,,, "3-aminomethyl-3,5,5-trimethylcyclohexylamine",2855-13-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0aa1e82-e077-4783-b63a-d954475485e3/documents/IUC5-c105f4d0-81c0-4902-9076-162a426fd4db_b4386327-3a77-435f-adb6-446537d744fa.html,,oral,LD50,"1,030 mg/kg bw",adverse effect observed, "3-aminomethyl-3,5,5-trimethylcyclohexylamine",2855-13-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0aa1e82-e077-4783-b63a-d954475485e3/documents/IUC5-c105f4d0-81c0-4902-9076-162a426fd4db_b4386327-3a77-435f-adb6-446537d744fa.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-aminomethyl-3,5,5-trimethylcyclohexylamine",2855-13-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0aa1e82-e077-4783-b63a-d954475485e3/documents/IUC5-c105f4d0-81c0-4902-9076-162a426fd4db_b4386327-3a77-435f-adb6-446537d744fa.html,,inhalation,LC50,"5,010 mg/m3",no adverse effect observed, "3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate",4098-71-9,"Partly cited from SIAR for SIAM 23 (Jeju, Korea, October 17-20, 2006):""No repeated-dose toxicity tests are available for the oral and dermal route of exposure. A subacute inhalation study (0.24, 1.05, and 4.1 mg/m3; 6 hours/day, 5 days/week, 4 weeks; OECD TG 412) with male and female Wistar rats indicates the respiratory tract to be the target organ. Clinical signs of respiratory tract irritation (nostrils: red encrustations, stridor, nasal discharge, breathing sounds, hypothermia) are restricted to the high concentration rats."" The LOAEC is 1.05 mg/m3 (histopathological changes in nasal cavity and larynx). ""At 4.1 mg/m3 also the pharynx, trachea, and lungs are affected but the lesions are reversible within the four weeks of recovery with regard to the lung and trachea. However, lesions in the nasal cavity, the pharynx, and the larynx still occurred in some animals with minimal or slight degree. The most relevant systemic effects were a slight decrease in body weight gain in the high dose group and an increased leukocyte count in the peripheral blood in mid and high dose groups."" The NOAEC is 0.24 mg/m3.A subchronic 13 week inhalation study demonstrates that rats exposed up to 1.1 mg/m3 of the test substance Isophorone Diisocyanate did not display any substance-induced clinical effects, changes in reflexes and body temperature, conclusively affected body weights or food/water consumption. There was no evidence of hematological effects. Clinical pathology and urinanalysis were unobtrusive. There were no statistically significant or conclusive dose-dependend changes in absolute or relative organ weights. The histopathological evaluation of the nasal cavity and the larynx revealed minimal or slight epithelial changes at 1.1 mg/m3. After a four week recovery period minimal epithelial metaplasia could still be detected; however clear evidence of recovery existed. This study demonstrated that the test substance was tolerated without any systemic adverse effects or clinical findings suggestive of respiratory tract irritation at any exposure level. Taking all findings into account, 0.27 mg/m3 constitutes a No-Observed-Adverse-Effect-Concentration (NOAEC). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0ab8d9d-5450-4669-a761-12d404008bdd/documents/IUC5-a688f19e-e645-4a04-94ee-eabfac96f9ad_90926473-ef21-4acb-b927-0eeddb601c0a.html,,,,,, "3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate",4098-71-9,"Cited from SIAR for SIAM 23 (Jeju, Korea, October 17-20, 2006):""Assessment of the acute inhalation toxicity data indicates that effects caused by exposure to respirable aerosols of 3 isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate were confined predominantly to the respiratory tract. Clinical signs (serous nasal discharge, bradypnea, stridor) indicated respiratory distress. There are two studies according to OECD TG 403 with LC50-values (4 h, rat) of approximately 40 mg/m3 and 31 mg/m3, respectively. Special investigations with male rats revealed airway rather than pulmonary irritation, which became evident after exposure of a concentration causing some lethality (25 mg/m3, 1 x 6 h). The dermal LD50 determined in compliance with OECD TG 402 was > 7000 mg/kg bw for rats. Non-specific, transient signs of intoxication (sedation, ataxia) and obvious skin irritation at the application site were reported. The available studies revealed a low oral toxicity with LD50-values (rat) of 4814 - 5490 mg/kg bw. Toxic symptoms after oral administration included decreased activity, piloerection, and diarrhea."" ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0ab8d9d-5450-4669-a761-12d404008bdd/documents/IUC5-50476902-4734-4369-93ab-c1234891e498_90926473-ef21-4acb-b927-0eeddb601c0a.html,,,,,, "3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate",4098-71-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0ab8d9d-5450-4669-a761-12d404008bdd/documents/IUC5-50476902-4734-4369-93ab-c1234891e498_90926473-ef21-4acb-b927-0eeddb601c0a.html,,oral,LD50,"4,814 mg/kg bw",adverse effect observed, "3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate",4098-71-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0ab8d9d-5450-4669-a761-12d404008bdd/documents/IUC5-50476902-4734-4369-93ab-c1234891e498_90926473-ef21-4acb-b927-0eeddb601c0a.html,,dermal,LD50,"7,000 mg/kg bw",no adverse effect observed, "3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate",4098-71-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0ab8d9d-5450-4669-a761-12d404008bdd/documents/IUC5-50476902-4734-4369-93ab-c1234891e498_90926473-ef21-4acb-b927-0eeddb601c0a.html,,inhalation,LC50,31 mg/m3,adverse effect observed, Isophthalic acid,121-91-5,The substance was found to be of low toxicity in a 90-day dietary rat study and in a 28-day rat inhalation study. Effects in the dietary study were limited to urolithiasis and secondary effects; findings were more marked in males. No clear or significant effects of treatment were seen in the inhalation study. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78483b41-5505-444c-847a-7ae57c3c7e2e/documents/IUC5-c5f66621-d320-42f6-9055-7222ad7807e6_e8559910-67dc-450f-93bb-1524d622c08a.html,,,,,, Isophthalic acid,121-91-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78483b41-5505-444c-847a-7ae57c3c7e2e/documents/IUC5-c5f66621-d320-42f6-9055-7222ad7807e6_e8559910-67dc-450f-93bb-1524d622c08a.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,9.59 mg/m3,,rat Isophthalic acid,121-91-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78483b41-5505-444c-847a-7ae57c3c7e2e/documents/IUC5-c5f66621-d320-42f6-9055-7222ad7807e6_e8559910-67dc-450f-93bb-1524d622c08a.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,500 mg/kg bw/day,,rat Isophthalic acid,121-91-5,"Studies indicate that isophthalic acid is of very low toxicity by the oral, inhalation and dermal routes. Acute oral LD50 values of >5000, 10900 and 13000 mg/kg bw are reported. An inhalation LC50 of greater than 11.37 mg/L is reported. A dermal LD50 of >2000 mg/kg bw is also reported. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78483b41-5505-444c-847a-7ae57c3c7e2e/documents/IUC5-fdfcc3cf-f365-4c69-88a8-0ad4f7ad0c73_e8559910-67dc-450f-93bb-1524d622c08a.html,,,,,, Isophthalic acid,121-91-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78483b41-5505-444c-847a-7ae57c3c7e2e/documents/IUC5-fdfcc3cf-f365-4c69-88a8-0ad4f7ad0c73_e8559910-67dc-450f-93bb-1524d622c08a.html,,oral,LD50,"10,900 mg/kg bw",, Isophthalic acid,121-91-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78483b41-5505-444c-847a-7ae57c3c7e2e/documents/IUC5-fdfcc3cf-f365-4c69-88a8-0ad4f7ad0c73_e8559910-67dc-450f-93bb-1524d622c08a.html,,dermal,LD50,"2,000 mg/kg bw",, Isophthalic acid,121-91-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78483b41-5505-444c-847a-7ae57c3c7e2e/documents/IUC5-fdfcc3cf-f365-4c69-88a8-0ad4f7ad0c73_e8559910-67dc-450f-93bb-1524d622c08a.html,,inhalation,LC50,"11,370 mg/m3",, 1-aminopropan-2-ol,78-96-6,"In a sub-chronic Extended One Generation Reproductive Toxicity Study according to OECD test guideline 443, including Cohort 1 and a 10-weeks premating treatment period, the pre- and postnatal effects of the test substance on development were evaluated and a thorough evaluation of systemic toxicity in pregnant and lactating females and young and adult offspring of Wistar Han rats was performed. In addition, the study provided and/or confirmed information about the effects of the test material on the integrity and performance of the adult male and female reproductive systems. The design of this study was based on the final decision on a compliance check of the test material by ECHA (Decision no. CCH-D-2114546072-57-01/FE, date 16 March 2021.) The dose levels in this study were selected to be 0, 100, 300, 1000 mg/kg/day. In conclusion, based on the results of this Extended One Generation Reproductive Toxicity Study (including Cohort 1), the following No Observed Adverse Effect Level (NOAEL) of the test substance was established: General Toxicity (F0 and F1): 100 mg/kg/day (based on histopathological findings in the kidney of males starting at 300 mg/kg/day). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e49dd981-f5fe-4d92-8980-a3f1e5923716/documents/IUC5-a37ba5c2-77cb-47a0-946c-23e21c4f293f_3d1c054c-ece3-46fc-8739-5558a07f2bb5.html,,,,,, 1-aminopropan-2-ol,78-96-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e49dd981-f5fe-4d92-8980-a3f1e5923716/documents/IUC5-a37ba5c2-77cb-47a0-946c-23e21c4f293f_3d1c054c-ece3-46fc-8739-5558a07f2bb5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 1-aminopropan-2-ol,78-96-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e49dd981-f5fe-4d92-8980-a3f1e5923716/documents/IUC5-cb9bdb19-3dbe-4a0c-9a79-f88cd4912b5f_3d1c054c-ece3-46fc-8739-5558a07f2bb5.html,,oral,LD50,"2,813 mg/kg bw",adverse effect observed, 1-aminopropan-2-ol,78-96-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e49dd981-f5fe-4d92-8980-a3f1e5923716/documents/IUC5-cb9bdb19-3dbe-4a0c-9a79-f88cd4912b5f_3d1c054c-ece3-46fc-8739-5558a07f2bb5.html,,dermal,LD50,"1,851 mg/kg bw",adverse effect observed, 1-aminopropan-2-ol,78-96-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e49dd981-f5fe-4d92-8980-a3f1e5923716/documents/IUC5-cb9bdb19-3dbe-4a0c-9a79-f88cd4912b5f_3d1c054c-ece3-46fc-8739-5558a07f2bb5.html,,inhalation,discriminating conc.,"3,460 mg/m3",no adverse effect observed, Isopropyl acetate,108-21-4," Adequate studies of the repeated dose toxicity of isopropyl acetate were not found.  The repeated dose toxicity of the in vivo hydrolysis product, isopropanol, has been studied by inhalation in rats and mice.  The NOAEL of 500 ppm isopropanol seen in the rat and mouse corresponds to 394 ppm (1.675 mg/L) isopropyl acetate and a LOAEL of 1500 ppm isopropyl alcohol corresponds to 1181 ppm (4.9 mg/L) isopropyl acetate after correcting for differences in total respiratory bioavailability. Exposure to high concentrations of isopropyl acetate or the in vivo hydrolysis product isopropanol have been reported to produce narcosis in exposed rats.  No presistent neurotoxicity was seen in subchronic studies of isopropanol. Data on ethyl acetate can be used to predict the potential for local effects through hydrolysis in the URT. Based on this available data, the BMDL10 for isopropyl acetate is predicted to be in the region 272 -523mg/m3 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c32fd221-9190-4b6c-98c0-0bda5cdb9fd5/documents/IUC5-6ab4cb02-7e41-4ad7-8d18-625a2f7d7825_d985ec00-e18e-462c-9ee0-655b04b68943.html,,,,,, Isopropyl acetate,108-21-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c32fd221-9190-4b6c-98c0-0bda5cdb9fd5/documents/IUC5-6ab4cb02-7e41-4ad7-8d18-625a2f7d7825_d985ec00-e18e-462c-9ee0-655b04b68943.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,650 mg/m3",,rat Isopropyl acetate,108-21-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c32fd221-9190-4b6c-98c0-0bda5cdb9fd5/documents/IUC5-6ab4cb02-7e41-4ad7-8d18-625a2f7d7825_d985ec00-e18e-462c-9ee0-655b04b68943.html,Repeated dose toxicity – local effects,inhalation,BMCL10,272 mg/m3,adverse effect observed,rat Isopropyl acetate,108-21-4,"Available acute toxicity values for isopropyl acetate are:Oral LD50 (rat) - 3000, 6750, 10900, 14964 mg/kg. 7.07, 9.85, 10.4, 11.3ml/kg. Oral LD50 (mouse) - 6650mg/kg. Oral LD50 (rabbit): 6945Inhalation 8-hr LC50 (rat) - 50,600 mg/m3 (reliable study). LC0 (30mins) >133,669mg/l. LC100 (4hrs) <133669mg/lDermal LD50, 24-hr occlusive exposure (rabbit) - >17.4 g/kg ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c32fd221-9190-4b6c-98c0-0bda5cdb9fd5/documents/IUC5-03f7e1f2-4689-436d-b423-a26cb5604a89_d985ec00-e18e-462c-9ee0-655b04b68943.html,,,,,, Isopropyl acetate,108-21-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c32fd221-9190-4b6c-98c0-0bda5cdb9fd5/documents/IUC5-03f7e1f2-4689-436d-b423-a26cb5604a89_d985ec00-e18e-462c-9ee0-655b04b68943.html,,oral,LD50,"6,750 mg/kg bw",, Isopropyl acetate,108-21-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c32fd221-9190-4b6c-98c0-0bda5cdb9fd5/documents/IUC5-03f7e1f2-4689-436d-b423-a26cb5604a89_d985ec00-e18e-462c-9ee0-655b04b68943.html,,inhalation,LC50,"50,600 mg/m3",, Propan-2-ol,67-63-0, GLP-guideline study according to OECD guideline 451 in rats is available for IPA. The derived NOAEC is 5000 ppm. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f2dce16-c574-4365-9d33-902b13079692/documents/IUC5-676b032e-a654-4f69-959e-0d1864fed781_106816fd-5418-44b2-b311-4f13ff63bd3d.html,,,,,, Propan-2-ol,67-63-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f2dce16-c574-4365-9d33-902b13079692/documents/IUC5-676b032e-a654-4f69-959e-0d1864fed781_106816fd-5418-44b2-b311-4f13ff63bd3d.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"12,500 mg/m3",, Propan-2-ol,67-63-0," Isopropanol is associated with low acute oral toxicity. The oral LD50 was reported to be 5840 mg/kg body weight in rats administered the test article by gavage (Smyth and Carpenter, 1948). No other study details were provided. Isopropanol is associated with low acute dermal toxicity following dermal exposure. Smyth and Carpenter (1948)  reported a dermal LD50 for isopropanol of 16.4 mL/kg body weight in rabbits. Isopropanol was reported to be well tolerated in rats at inhalation exposures up to 1500 ppm for 6 hours (Gill, 1991). At higher dose levels (5000 and 10000 ppm) a number of clinical signs were observed, including transient central system sedation and reversible narcosis. No mortalities were observed at exposures up to 10000 ppm. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f2dce16-c574-4365-9d33-902b13079692/documents/IUC5-d771b731-bf53-42c4-a90c-ffac2e54c00a_106816fd-5418-44b2-b311-4f13ff63bd3d.html,,,,,, Propan-2-ol,67-63-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f2dce16-c574-4365-9d33-902b13079692/documents/IUC5-d771b731-bf53-42c4-a90c-ffac2e54c00a_106816fd-5418-44b2-b311-4f13ff63bd3d.html,,oral,LD50,"5,840 mg/kg bw",no adverse effect observed, Propan-2-ol,67-63-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f2dce16-c574-4365-9d33-902b13079692/documents/IUC5-d771b731-bf53-42c4-a90c-ffac2e54c00a_106816fd-5418-44b2-b311-4f13ff63bd3d.html,,dermal,LD50,"13,900 mg/kg bw",no adverse effect observed, Propan-2-ol,67-63-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f2dce16-c574-4365-9d33-902b13079692/documents/IUC5-d771b731-bf53-42c4-a90c-ffac2e54c00a_106816fd-5418-44b2-b311-4f13ff63bd3d.html,,inhalation,LC50,"25,000 mg/m3",adverse effect observed, 4-isopropyl-m-cresol,3228-02-2,"NOAEL = 15000 ppm (1038 or 1010 mg/kg bw/day for males or females, respectively) (OECD 422, GLP, K, rel. 1) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38eb84d0-c93b-4c35-88b0-8c998dd5ea8e/documents/IUC5-f3aa7fe8-ceb9-4668-999d-387d13387478_47716729-e5e5-4156-ac29-93bddfba82c7.html,,,,,, 4-isopropyl-m-cresol,3228-02-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38eb84d0-c93b-4c35-88b0-8c998dd5ea8e/documents/IUC5-f3aa7fe8-ceb9-4668-999d-387d13387478_47716729-e5e5-4156-ac29-93bddfba82c7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-isopropyl-m-cresol,3228-02-2,"Acute toxicity: oral: LD50 > 2200 mg/kg bw (similar to OECD 401 in mice, WoE);Acute toxicity: inhalation: LC50 > 1.41 mg/L (maximim attainable atmosphere concentration) (OECD 403, rats, K, rel.1)Acute toxicity: dermal: LD50 >2000 mg/kg bw (OECD 402, rats, K, rel. 1); ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38eb84d0-c93b-4c35-88b0-8c998dd5ea8e/documents/IUC5-9f338a24-9a88-4ba6-a0f2-24c35b698f0a_47716729-e5e5-4156-ac29-93bddfba82c7.html,,,,,, 4-isopropyl-m-cresol,3228-02-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38eb84d0-c93b-4c35-88b0-8c998dd5ea8e/documents/IUC5-9f338a24-9a88-4ba6-a0f2-24c35b698f0a_47716729-e5e5-4156-ac29-93bddfba82c7.html,,oral,LD50,"2,200 mg/kg bw",no adverse effect observed, 4-isopropyl-m-cresol,3228-02-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38eb84d0-c93b-4c35-88b0-8c998dd5ea8e/documents/IUC5-9f338a24-9a88-4ba6-a0f2-24c35b698f0a_47716729-e5e5-4156-ac29-93bddfba82c7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-isopropyl-m-cresol,3228-02-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38eb84d0-c93b-4c35-88b0-8c998dd5ea8e/documents/IUC5-9f338a24-9a88-4ba6-a0f2-24c35b698f0a_47716729-e5e5-4156-ac29-93bddfba82c7.html,,inhalation,LC50,"1,410 mg/m3",no adverse effect observed, 4-(isopropyl)cyclohexyl propionate,63449-95-6,Acute oral toxicity: OECD TG 401: 6600 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94d9b06d-59f3-4085-96a9-ad3e7b4bb728/documents/7529a6f5-8a5d-40a7-8af7-7162d3fce15e_103061bb-d364-40f0-b499-0eda78686e75.html,,,,,, Isopropyl isodecanoate,68171-33-5,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/105988a6-8f26-4598-8f83-a71dd4a2ee21/documents/IUC5-a30076e7-6485-4489-95df-a7cceff09338_dbaa54d4-6c5f-49c2-bccf-7d9162d2c121.html,,,,,, Isopropyl isodecanoate,68171-33-5,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/105988a6-8f26-4598-8f83-a71dd4a2ee21/documents/IUC5-f347ffa7-95d7-48dc-946b-c33954160690_dbaa54d4-6c5f-49c2-bccf-7d9162d2c121.html,,,,,, "Fatty acids, lanolin, iso-Pr esters",63393-93-1,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eea853bb-8816-46e9-a2fa-9aa73544797f/documents/1950f4ef-25e4-40f9-9829-95b0f1ec84b8_86d043d9-99b2-4eda-b09c-63bc560cc55e.html,,,,,, "Fatty acids, lanolin, iso-Pr esters",63393-93-1,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eea853bb-8816-46e9-a2fa-9aa73544797f/documents/d724b871-681a-439a-9b61-490eea585162_86d043d9-99b2-4eda-b09c-63bc560cc55e.html,,,,,, Isopropyl laurate,10233-13-3,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5683934c-ddb3-4cfc-8050-d14ad24bc5a7/documents/IUC5-2be39757-41f7-4a49-b03d-300254e7bacb_521e25b9-6ebd-4811-92e7-a8b059f5214b.html,,,,,, Isopropyl laurate,10233-13-3,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5683934c-ddb3-4cfc-8050-d14ad24bc5a7/documents/IUC5-b7765b29-fc70-4101-8017-28197aa32203_521e25b9-6ebd-4811-92e7-a8b059f5214b.html,,,,,, propan-2-yl 2-(N-methyldodecanamido)acetate,230309-38-3," Oral administration of the test item to Wistar rats at doses of 0, 50, 200 or 1000 mg/kg bw/day for 28 days resulted in no changes in mortality rates, no clinical signs, no changes in the parameters of the functional observation battery (including grip strength and locomotor activity), no differences in food consumption or body weight, no effects upon haematology or clinical biochemistry parameters, no macroscopic findings and no microscopic findings. Treatment-related findings were generally restricted to increases in liver weights of males and females treated with 1000 mg/kg bw/day and increases in kidney weights of females treated with 1000 mg/kg bw/day. Based on the results of this study, 200 mg/kg bw/day was established as the no-observed-effect-level (NOEL). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb0ac6f0-5eaa-4e24-999a-8822cc2de688/documents/IUC5-319128b8-a4fb-48ad-a339-440aad057740_c022df09-f618-456d-8ff0-67724f8b701c.html,,,,,, propan-2-yl 2-(N-methyldodecanamido)acetate,230309-38-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb0ac6f0-5eaa-4e24-999a-8822cc2de688/documents/IUC5-319128b8-a4fb-48ad-a339-440aad057740_c022df09-f618-456d-8ff0-67724f8b701c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat propan-2-yl 2-(N-methyldodecanamido)acetate,230309-38-3," Acute oral toxicity: One group of three male or three female HanBrl: WIST (SPF) rats was treated by oral gavage with the test item at 2000 mg/kg bw. The test item was suspended in vehicle (PEG 300) at a concentration of 0.2 g/mL and administered at a volume of 10 mL/kg. The animals were examined for clinical signs daily during the acclimatization period, four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded daily during the acclimatization period and together with clinical signs at the same time intervals on test day 1 and twice daily on test days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. All animals survived until the end of the study period. No clinical signs were evident during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. The median lethal dose of the test item was > 2000 mg/kg bw. Acute dermal toxicity: A group of five male and five female HanBrl: WIST (SPF) rats was treated with the test item at 1840 mg/kg by dermal application. The test item was used undiluted and administered at a volume of 2 mL/kg. A second group of five male and five female HanBrl: WIST (SPF) rats was treated with the test item at 2000 mg/kg by dermal application. The test item was used undiluted and administered at a volume of 2.2 mL/kg. The animals were examined for clinical signs four times during test day 1 and once daily during test days 2-15. Mortality/viability was recorded together with clinical signs at the same time intervals on test day 1. During test days 2-15 it was recorded two times a day. Body weights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically. No deaths occurred during the study. Slight scales were observed in one female dosed with 1840 mg/kg on test day 8 until test day 12. All other animals were without clinical signs. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. The median lethal dose of the test item was > 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb0ac6f0-5eaa-4e24-999a-8822cc2de688/documents/IUC5-666260ad-3c70-447c-9dba-1b8f12b56764_c022df09-f618-456d-8ff0-67724f8b701c.html,,,,,, propan-2-yl 2-(N-methyldodecanamido)acetate,230309-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb0ac6f0-5eaa-4e24-999a-8822cc2de688/documents/IUC5-666260ad-3c70-447c-9dba-1b8f12b56764_c022df09-f618-456d-8ff0-67724f8b701c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, propan-2-yl 2-(N-methyldodecanamido)acetate,230309-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb0ac6f0-5eaa-4e24-999a-8822cc2de688/documents/IUC5-666260ad-3c70-447c-9dba-1b8f12b56764_c022df09-f618-456d-8ff0-67724f8b701c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Isopropyl oleate,112-11-8,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/433c2264-fa6f-477e-b3da-8a383f08b618/documents/IUC5-2be39757-41f7-4a49-b03d-300254e7bacb_757b7c5c-f951-41f9-9253-a4b4e836db0a.html,,,,,, Isopropyl oleate,112-11-8,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/433c2264-fa6f-477e-b3da-8a383f08b618/documents/IUC5-b7765b29-fc70-4101-8017-28197aa32203_757b7c5c-f951-41f9-9253-a4b4e836db0a.html,,,,,, Isopropyl palmitate,142-91-6,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25d42e9b-b60d-4ceb-93f9-162e212783c6/documents/IUC5-2be39757-41f7-4a49-b03d-300254e7bacb_738b7803-0d69-4395-ae37-8596a5d03aa3.html,,,,,, Isopropyl palmitate,142-91-6,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25d42e9b-b60d-4ceb-93f9-162e212783c6/documents/IUC5-b7765b29-fc70-4101-8017-28197aa32203_738b7803-0d69-4395-ae37-8596a5d03aa3.html,,,,,, 2-isopropyl-9H-thioxanthen-9-one,5495-84-1,"Two 28-day repeated toxicity studies are available on 2-isopropyl-9H-thioxanthen-9-one. According to the results obtained in the Key study (van Otterdijk, 2006), the NOAEL was 150 mg/kg/day. The key study is considered to be reliable with a klimisch score of 1. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a88d04cb-2cbc-4482-b107-7bcff9397b9d/documents/3cc7d9e7-a655-4bd6-b562-e201b05b1409_7532df87-2aca-4e4b-beee-e36e0ee24031.html,,,,,, 2-isopropyl-9H-thioxanthen-9-one,5495-84-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a88d04cb-2cbc-4482-b107-7bcff9397b9d/documents/3cc7d9e7-a655-4bd6-b562-e201b05b1409_7532df87-2aca-4e4b-beee-e36e0ee24031.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat 2-isopropyl-9H-thioxanthen-9-one,5495-84-1,"Under the conditions of the studies performed, the oral and dermal LD50 value were established to exceed 2 000 mg/kg body weight. The study was awarded a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a88d04cb-2cbc-4482-b107-7bcff9397b9d/documents/28012850-dda1-4ea1-af24-be0a9f0a5a3a_7532df87-2aca-4e4b-beee-e36e0ee24031.html,,,,,, 2-isopropyl-9H-thioxanthen-9-one,5495-84-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a88d04cb-2cbc-4482-b107-7bcff9397b9d/documents/28012850-dda1-4ea1-af24-be0a9f0a5a3a_7532df87-2aca-4e4b-beee-e36e0ee24031.html,,oral,LD0,"2,000 mg/kg bw",no adverse effect observed, 2-isopropyl-9H-thioxanthen-9-one,5495-84-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a88d04cb-2cbc-4482-b107-7bcff9397b9d/documents/28012850-dda1-4ea1-af24-be0a9f0a5a3a_7532df87-2aca-4e4b-beee-e36e0ee24031.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, Tris(isooctadecanoato-O)(propan-2-olato)titanium,61417-49-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c67e70ff-75b6-4a9b-847d-6a85c09857f1/documents/20157ae3-c83b-496b-8a82-b7d68f022461_974b5ea4-5031-451c-bc11-93d98f091ee7.html,,oral,LD50,"30,000 mg/kg bw",no adverse effect observed, "(R)-5-isopropyl-2-methylcyclohexa-1,3-diene",4221-98-1," Based on thes results of the OECD 422 study, the NOAEL of the test substance for systemic toxicity was considered to be 200 mg/kg/day for males and 75 mg/kg bw/day for females. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77315a00-1053-429f-b460-3d0ee6869100/documents/3e0a05b5-52bb-4b0d-9bf7-62e4dba584da_65e78bb3-45db-49d3-9bba-9dea909b7533.html,,,,,, "(R)-5-isopropyl-2-methylcyclohexa-1,3-diene",4221-98-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77315a00-1053-429f-b460-3d0ee6869100/documents/3e0a05b5-52bb-4b0d-9bf7-62e4dba584da_65e78bb3-45db-49d3-9bba-9dea909b7533.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat "(R)-5-isopropyl-2-methylcyclohexa-1,3-diene",4221-98-1, Acute oral toxicity The LD50 of the test substance was determined to be 5700 mg/kg bw.   Acute dermal toxicity In the acute dermal toxicity study the LD50 was determined to be greater than 5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77315a00-1053-429f-b460-3d0ee6869100/documents/IUC5-ecd8fbb7-16c5-4fbe-83d9-40178b6aca30_65e78bb3-45db-49d3-9bba-9dea909b7533.html,,,,,, "(R)-5-isopropyl-2-methylcyclohexa-1,3-diene",4221-98-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77315a00-1053-429f-b460-3d0ee6869100/documents/IUC5-ecd8fbb7-16c5-4fbe-83d9-40178b6aca30_65e78bb3-45db-49d3-9bba-9dea909b7533.html,,oral,LD50,"5,700 mg/kg bw",no adverse effect observed, "(R)-5-isopropyl-2-methylcyclohexa-1,3-diene",4221-98-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77315a00-1053-429f-b460-3d0ee6869100/documents/IUC5-ecd8fbb7-16c5-4fbe-83d9-40178b6aca30_65e78bb3-45db-49d3-9bba-9dea909b7533.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, N-isopropylacrylamide,2210-25-5, When a fixed slope of 8.333 was assumed the acute median lethal oral dose of isopropyl acrylamide and its 95% confidence limits were estimated to be: Males and females combined: 383 (322 to 454) mg/kg bodyweight Males only: 383 (300 to 487) mg/kg bodyweight Females only: 383 (300 to 487) mg/kg bodyweight Based on the conclusion the final LD50 value is concluded as 383 mg/kg/day. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/138c84e3-eb3f-4112-9c20-c70af5ec27f3/documents/8ee3cbd4-92e1-4171-8194-348bcfe1f23b_a14143c4-457a-4ee6-b445-6937f8595d0b.html,,,,,, N-isopropylacrylamide,2210-25-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/138c84e3-eb3f-4112-9c20-c70af5ec27f3/documents/8ee3cbd4-92e1-4171-8194-348bcfe1f23b_a14143c4-457a-4ee6-b445-6937f8595d0b.html,,oral,LD50,383 mg/kg bw,adverse effect observed, Isopropylamine,75-31-0,"Isopropylamine produced no systemic but local effects (nasal inflammation in rats exposed by inhalation to 500 mg/m3 for 13 weeks), while 100 mg/m3 showed no adverse effects at all. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/daec61fa-d077-4caf-98b7-c69c66d18ad4/documents/51ec9056-f656-4b8d-a0e8-edc3aa17a9c3_02d34e62-8fbb-4d53-ad12-1fb367b95543.html,,,,,, Isopropylamine,75-31-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/daec61fa-d077-4caf-98b7-c69c66d18ad4/documents/51ec9056-f656-4b8d-a0e8-edc3aa17a9c3_02d34e62-8fbb-4d53-ad12-1fb367b95543.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,500 mg/m3,,rat Isopropylamine,75-31-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/daec61fa-d077-4caf-98b7-c69c66d18ad4/documents/51ec9056-f656-4b8d-a0e8-edc3aa17a9c3_02d34e62-8fbb-4d53-ad12-1fb367b95543.html,Repeated dose toxicity – local effects,inhalation,NOAEC,100 mg/m3,adverse effect observed,rat Isopropylamine,75-31-0,"LD50(oral, rat) <172 mg/kg bw (undiluted) / mean LD50(oral, rat) = 550 - 820 mg/kg bw (diluted in water or olive oil); mean LC50(inh., rat) = 8.7 mg/L;LD50(dermal, rat) > 400 mg/kg bw (diluted, 10 % in water; no animal died at this dose which already was corrosive to the skin) and a LD50 (dermal, rabbit) of 378 mg/kg has been reported in rabbits. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/daec61fa-d077-4caf-98b7-c69c66d18ad4/documents/a8bdf10f-454a-4bdc-a157-eb20d1c67724_02d34e62-8fbb-4d53-ad12-1fb367b95543.html,,,,,, Isopropylamine,75-31-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/daec61fa-d077-4caf-98b7-c69c66d18ad4/documents/a8bdf10f-454a-4bdc-a157-eb20d1c67724_02d34e62-8fbb-4d53-ad12-1fb367b95543.html,,oral,LD50,172 mg/kg bw,adverse effect observed, Isopropylamine,75-31-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/daec61fa-d077-4caf-98b7-c69c66d18ad4/documents/a8bdf10f-454a-4bdc-a157-eb20d1c67724_02d34e62-8fbb-4d53-ad12-1fb367b95543.html,,dermal,discriminating dose,400 mg/kg bw,no adverse effect observed, Isopropylamine,75-31-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/daec61fa-d077-4caf-98b7-c69c66d18ad4/documents/a8bdf10f-454a-4bdc-a157-eb20d1c67724_02d34e62-8fbb-4d53-ad12-1fb367b95543.html,,inhalation,LC50,"8,700 mg/m3",adverse effect observed, [2-(Isopropoxycarbonyloxy)-benzoyl]-benzoylperoxide,1310672-91-3," Supporting data on repeated dose toxicity are available for CD08467 and for the read-across partner CD08479. In a repeated dose toxicity study, the test item CD08467 (purity 98.3%LC) was applied orally by gavage to Göttingen® minipigs (1/sex/dose) at dose levels of 0, 300, 600 and 1200 mg/kg bw/day for 14 days. At 1200 mg/kg/day, notable effects on physiological parameters, such as reduced body weight and food consumption, were noticed. These signs were associated with microscopic findings in the female of high-dose level group such as multifocal ulcers/erosions in the cardia region of the stomach and slight but diffuse hepatocytes vacuolation of the liver. These microscopic findings associated with effects on physiological parameters could be related to the high dose level. Since this study has methodological limitations (1 animal per sex per dose used, 14-day exposure, study not performed under the scope of GLP), it cannot be used to dertermine a NOAEL and has to be regarded as supportive information for repeated dose toxicity. In a 14-day repeated dose toxicity study, the test item CD08479 (purity: 98.1%) was applied orally by gavage to Wistar rats (6/sex/dose) at dose levels of 0, 90, 260 or 420 mg/kg bw/day in carboxymethyl cellulose (CMC) 0.1% / PG 4% / 0.2% Poloxamer 124 for 14 consecutive days. In this study, no adverse effects were observed up to the highest dose. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a9603f8-ab22-452b-9afa-7803dab685e6/documents/76056851-ae42-46d4-a171-aa9616a5f45a_33c55964-bee1-455c-a1db-17c897b3b366.html,,,,,, [2-(Isopropoxycarbonyloxy)-benzoyl]-benzoylperoxide,1310672-91-3," An additional acute toxicity study is not necessary as there is data available from short-term 14-day repeated dose toxicity studies of CD08467 and CD08479 in minipigs and rats, respectively. Repeated dose-administration studies supersede the need of additional single dose acute toxicity testing. The acute toxicity potential of CD08467 as well as its analogue CD08479 has been investigated in two sub-acute studies (see IUCLID section 7.5.1: Weiler, 2012 and Maury, 2012). CD08467 was administered daily for 2 weeks via oral gavage to minipigs at 300, 600, or 1 200 mg/kg bw/day (the maximal feasible dose due to the limit of formulability of CD08467). No mortality was observed with all 3 doses and slight treatment-related effects were seen only at the highest dose of 1 200 mg/kg. No toxicity was seen at 300 or 600 mg/kg bw/day. In another study, CD08479, the structurally related analogue of CD08467, was administered daily to rats at 420 mg/kg bw/day for 2 weeks, and no toxicity was observed at this dose. Thus, the sub-acute non-toxic dose levels have been demonstrated to be 600 mg/kg bw/day in minipigs for CD08467 and 420 mg/kg bw/day in rats for CD08479. Based on the available data showing no mortality of both studies, it can be expected that the LD50 of CD08467 by oral route is higher than the maximum (technically feasible) dose of 1 200 mg/kg bw/day in the minipigs (non-rodent toxicity with CD08467) and higher than 420 mg/kg bw/day in the rat (rodent toxicity with CD08479). In addition, both CD08467 and CD08479 are rapidly converted into salicylic acid and benzoic acid (1 mol CD08467 or CD08479 yields 1 mol salicylic acid and 1 mol benzoic acid), which are known compounds with available acute toxicity data. According to the ECHA’s C&L inventory, benzoic acid is not classified for acute toxicity. Salicylic acid is classified as Acute Tox. 4 (H302) based on a LD50 of 891 mg/kg bw (see registration dossier of salicylic acid). By extrapolating the LD50 of the metabolite salicylic acid (MW = 122.12 g/mol) to CD08467 (MW = 344.32 g/mol), the LD50 for CD08467 would be 2512 mg/kg bw, and thus, no classification is warranted for CD08467 for acute toxicity based on the criteria under CLP Regulation. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a9603f8-ab22-452b-9afa-7803dab685e6/documents/0525bf80-37e7-43c9-a243-8bf643b69ebd_33c55964-bee1-455c-a1db-17c897b3b366.html,,,,,, 4-isopropylcyclohexanol,4621-04-9," Acute Oral: Based on the LD50 results from the Moreno study (4 rats died at 2560 mg/kg and 9 died at 5000 mg/kg) and the IFF study (3 rats died at 2000 mg/kg and 7 died at 3200 mg/kg), the LD50 is therefore greater than 2000 mg/kg but less than 3200 mg/kg. In the IFF study the LD50 was determined to be 2607 mg/kg. Therefore the substance is classified Category 5 for oral toxicity under GHS guidance. Acute Dermal: No rabbits died at 5000 mg/kg. Therefore no classification is required under GH guidance. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45b47c6a-8bc2-4c75-9e29-30ed520fb4a1/documents/b36d6597-e83a-47b5-9ced-cd54ec26a87f_5b505eda-e64e-418a-8621-5df51dd8228c.html,,,,,, 4-isopropylcyclohexanol,4621-04-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45b47c6a-8bc2-4c75-9e29-30ed520fb4a1/documents/b36d6597-e83a-47b5-9ced-cd54ec26a87f_5b505eda-e64e-418a-8621-5df51dd8228c.html,,oral,LD50,"2,607 mg/kg bw",adverse effect observed, "2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane",1675-54-3,"Administration of DGEBPA via oral gavage resulted in slight body weight effects at 250 mg/kg/day and higher. Enlarged cecum was noted at necropsy in male rats receiving 250 mg/kg/day. Slight histopathologic changes were noted in the adrenal gland, cecum and kidney of male and/or female rats ingesting 250 mg/kg/day. A 3% decrease in body weight was noted in female rats gavaged with 50 mg/kg/day and a slight increase in cholesterol levels was noted which was considered to be not detrimental.In a dermal study, the only systemic toxicity was a slight decrease in body weights at 1000 mg/kg/day. Thus the NOAEL for systemic toxicity was considered to be 100 mg/kg/day. The NOEL for dermal effects in female rats was 10 mg/kg/day. In male rats a NOEL for dermal effects was not detected. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6fc4476-beba-4908-bb53-742b8ce9ad51/documents/IUC5-bcd2c316-bfe2-49fc-9724-ef0bb019daab_0025b2f7-b630-48e2-9f72-16476b5b3769.html,,,,,, "2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane",1675-54-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6fc4476-beba-4908-bb53-742b8ce9ad51/documents/IUC5-bcd2c316-bfe2-49fc-9724-ef0bb019daab_0025b2f7-b630-48e2-9f72-16476b5b3769.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,,rat "2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane",1675-54-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6fc4476-beba-4908-bb53-742b8ce9ad51/documents/IUC5-bcd2c316-bfe2-49fc-9724-ef0bb019daab_0025b2f7-b630-48e2-9f72-16476b5b3769.html,Chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane",1675-54-3,The oral and dermal LD50 values were greater than the highest doses tested. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6fc4476-beba-4908-bb53-742b8ce9ad51/documents/IUC5-cfe30c97-0307-44f6-93f8-ff2dd735fd1e_0025b2f7-b630-48e2-9f72-16476b5b3769.html,,,,,, "2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane",1675-54-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6fc4476-beba-4908-bb53-742b8ce9ad51/documents/IUC5-cfe30c97-0307-44f6-93f8-ff2dd735fd1e_0025b2f7-b630-48e2-9f72-16476b5b3769.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane",1675-54-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6fc4476-beba-4908-bb53-742b8ce9ad51/documents/IUC5-cfe30c97-0307-44f6-93f8-ff2dd735fd1e_0025b2f7-b630-48e2-9f72-16476b5b3769.html,,dermal,LD50,"23,000 mg/kg bw",no adverse effect observed, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, esters with acrylic acid",55818-57-0," Based on the 90-day repeated toxicity study, no-observed adverse effect levels (NOAEL) for systemic effects were below the lowest tested dose level of 100 mg/kg body weight/day of DGEBADA. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14ae3a76-7b0f-4c27-a097-9c480f6eb9ed/documents/IUC5-921e4315-afa7-4f41-9a3c-856047a947c4_25b3d107-5d86-4682-b47d-51c8a829d7d2.html,,,,,, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, esters with acrylic acid",55818-57-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14ae3a76-7b0f-4c27-a097-9c480f6eb9ed/documents/IUC5-921e4315-afa7-4f41-9a3c-856047a947c4_25b3d107-5d86-4682-b47d-51c8a829d7d2.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, esters with acrylic acid",55818-57-0,"Two studies are available to evaluate the acute toxicity of DGEBA diacrylate.By oral and dermal routes, no mortality or severe clinical signs were observed in rats treated with 2000 mg/kg of DGEBA diacrylate.No study by inhalation is available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14ae3a76-7b0f-4c27-a097-9c480f6eb9ed/documents/IUC5-0d8afb77-8244-4896-b6c2-3898a7526b24_25b3d107-5d86-4682-b47d-51c8a829d7d2.html,,,,,, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, esters with acrylic acid",55818-57-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14ae3a76-7b0f-4c27-a097-9c480f6eb9ed/documents/IUC5-0d8afb77-8244-4896-b6c2-3898a7526b24_25b3d107-5d86-4682-b47d-51c8a829d7d2.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, esters with acrylic acid",55818-57-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14ae3a76-7b0f-4c27-a097-9c480f6eb9ed/documents/IUC5-0d8afb77-8244-4896-b6c2-3898a7526b24_25b3d107-5d86-4682-b47d-51c8a829d7d2.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,2-dimethyl-1,3-dioxolan-4-ylmethanol",100-79-8,NOAEL (oral route) for systemic toxicity = 1000 mg/kg bw/day for males since the observed effects in males are not relevant for human risk assessment. NOEL (oral route) for systemic toxicity = 1000 mg/kg bw/day for females based on the absence of significant effects related to test item on females. NOAEC (inhalation route) for systemic and local effects = 5 mg/L (no relevant to human adverse effects reported) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a16b5dd4-2f23-4c42-8cea-fad83f2b9fdd/documents/IUC5-dcf6cb1b-710e-448f-b399-7c64d2656c27_fb105972-4f2b-4120-bccb-8abdccd513c6.html,,,,,, "2,2-dimethyl-1,3-dioxolan-4-ylmethanol",100-79-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a16b5dd4-2f23-4c42-8cea-fad83f2b9fdd/documents/IUC5-dcf6cb1b-710e-448f-b399-7c64d2656c27_fb105972-4f2b-4120-bccb-8abdccd513c6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2-dimethyl-1,3-dioxolan-4-ylmethanol",100-79-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a16b5dd4-2f23-4c42-8cea-fad83f2b9fdd/documents/IUC5-dcf6cb1b-710e-448f-b399-7c64d2656c27_fb105972-4f2b-4120-bccb-8abdccd513c6.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"5,000 mg/m3",,rat "2,2-dimethyl-1,3-dioxolan-4-ylmethanol",100-79-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a16b5dd4-2f23-4c42-8cea-fad83f2b9fdd/documents/IUC5-dcf6cb1b-710e-448f-b399-7c64d2656c27_fb105972-4f2b-4120-bccb-8abdccd513c6.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"5,000 mg/m3",no adverse effect observed,rat "2,2-dimethyl-1,3-dioxolan-4-ylmethanol",100-79-8,"- Oral LD50 (Key study lit. data, V2): 7000 mg/kg bw in rats - Dermal LD50 (Key study OECD 402, V1, 2013): > 2000 mg/kg bw in rats - Inhalation LC50 (Key study OECD 403, V1, 2015): > 5.11 mg/L in rats ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a16b5dd4-2f23-4c42-8cea-fad83f2b9fdd/documents/IUC5-ca01d45e-ed97-4f08-a2e2-8869db1a16bb_fb105972-4f2b-4120-bccb-8abdccd513c6.html,,,,,, "2,2-dimethyl-1,3-dioxolan-4-ylmethanol",100-79-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a16b5dd4-2f23-4c42-8cea-fad83f2b9fdd/documents/IUC5-ca01d45e-ed97-4f08-a2e2-8869db1a16bb_fb105972-4f2b-4120-bccb-8abdccd513c6.html,,oral,LD50,"7,000 mg/kg bw",no adverse effect observed, "2,2-dimethyl-1,3-dioxolan-4-ylmethanol",100-79-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a16b5dd4-2f23-4c42-8cea-fad83f2b9fdd/documents/IUC5-ca01d45e-ed97-4f08-a2e2-8869db1a16bb_fb105972-4f2b-4120-bccb-8abdccd513c6.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,2-dimethyl-1,3-dioxolan-4-ylmethanol",100-79-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a16b5dd4-2f23-4c42-8cea-fad83f2b9fdd/documents/IUC5-ca01d45e-ed97-4f08-a2e2-8869db1a16bb_fb105972-4f2b-4120-bccb-8abdccd513c6.html,,inhalation,discriminating conc.,"5,110 mg/m3",no adverse effect observed, "(2,2-dimethyl-1,3-dioxolan-4-yl)methyl methacrylate",7098-80-8, The LD50 was greater than 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/612ede80-7874-4050-8826-933e01c26d88/documents/eb38c6f0-5277-4919-aafd-22a6401fe947_49ce02f4-11c6-45b1-b6a2-6d4e0b5bc27d.html,,,,,, "(2,2-dimethyl-1,3-dioxolan-4-yl)methyl methacrylate",7098-80-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/612ede80-7874-4050-8826-933e01c26d88/documents/eb38c6f0-5277-4919-aafd-22a6401fe947_49ce02f4-11c6-45b1-b6a2-6d4e0b5bc27d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Isopropyl 4-hydroxybenzoate,4191-73-5, LD50 was considered to be > 2000 mg/kg bw when DDY male mice were treated with isopropyl 4-hydroxybenzoate orally. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e1dd2cc-38a9-4f4e-b6f1-db0fda5975f1/documents/a1a8e745-9ad3-497c-949f-9e845c9d3906_c89118ba-1d3f-4be6-9041-9709f6637a01.html,,,,,, Isopropyl 4-hydroxybenzoate,4191-73-5,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e1dd2cc-38a9-4f4e-b6f1-db0fda5975f1/documents/a1a8e745-9ad3-497c-949f-9e845c9d3906_c89118ba-1d3f-4be6-9041-9709f6637a01.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, β-methyl-3-(1-methylethyl)benzenepropanal,125109-85-5," NOAEL oral rat = 300mg/kg bw/d in an OECD 407, GLP study from 1991. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5f237b07-15ac-4ff5-9336-7d15af550d2d/documents/ec90c0aa-1cae-404d-818e-d7ba6c4acea0_d8f877b9-d906-4da4-a9b8-b4427d3d79ce.html,,,,,, β-methyl-3-(1-methylethyl)benzenepropanal,125109-85-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5f237b07-15ac-4ff5-9336-7d15af550d2d/documents/ec90c0aa-1cae-404d-818e-d7ba6c4acea0_d8f877b9-d906-4da4-a9b8-b4427d3d79ce.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat β-methyl-3-(1-methylethyl)benzenepropanal,125109-85-5, LD 50 oral > 2000 mg/kg LD50 dermal > 2000 mg/kg No acute inhalation study available. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f237b07-15ac-4ff5-9336-7d15af550d2d/documents/23325334-8bed-42c7-b99b-44bce56ef5fe_d8f877b9-d906-4da4-a9b8-b4427d3d79ce.html,,,,,, β-methyl-3-(1-methylethyl)benzenepropanal,125109-85-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f237b07-15ac-4ff5-9336-7d15af550d2d/documents/23325334-8bed-42c7-b99b-44bce56ef5fe_d8f877b9-d906-4da4-a9b8-b4427d3d79ce.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, β-methyl-3-(1-methylethyl)benzenepropanal,125109-85-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f237b07-15ac-4ff5-9336-7d15af550d2d/documents/23325334-8bed-42c7-b99b-44bce56ef5fe_d8f877b9-d906-4da4-a9b8-b4427d3d79ce.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Isopulegol,89-79-2,Acute oral toxicity: LD50 = 936 mg/kg bw (RIFM 1971)Acute dermal toxicity: LD50 = approx. 5 ml/kg bw (RIFM 1971) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c28ad44-c725-41c3-a4bb-6e1bc6732824/documents/IUC5-77f90222-96d0-4e07-b14d-61d456adf479_822ce345-475c-4841-b1af-cfbc617aa18c.html,,,,,, "1,4:3,6-dianhydro-D-glucitol",652-67-5,"Sprague Dawley rats were administered ad libitum with isosorbide by dietary admixture at concentrations of 12500, 25000 and 50000 ppm (corresponding to daily dose-levels of 784, 1577 or 3347 mg/kg/day for the males and 937, 2060 or 3970 mg/kg/day for the females) for 13 weeks. This GLP study was equivalent to OECD Test Guideline 408. The No Observed Effect Level (NOEL) was established at 12500 ppm (corresponding to 748 mg/kg/day in males and 937 mg/kg/day in females) and the No Observed Adverse Effect Level (NOAEL) was set at 50000 ppm (corresponding to 3347 mg/kg/day in males and 3970 mg/kg/day in females).No supporting oral studies were located and no inhalation or dermal repeat-dose toxicity studies have been conducted. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4185fe9-aa73-4faa-82ae-6e91e71043c3/documents/IUC5-0168ec34-360e-4a48-ab91-3e54ba0d42df_66e08ec7-3ada-4f45-96fd-736635d20419.html,,,,,, "1,4:3,6-dianhydro-D-glucitol",652-67-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4185fe9-aa73-4faa-82ae-6e91e71043c3/documents/IUC5-0168ec34-360e-4a48-ab91-3e54ba0d42df_66e08ec7-3ada-4f45-96fd-736635d20419.html,Chronic toxicity – systemic effects,oral,NOAEL,"3,347 mg/kg bw/day",,rat "1,4:3,6-dianhydro-D-glucitol",652-67-5,Oral: LD50: > 2000 mg/kg bw for ratDermal: LD50: > 2000 mg/kg bw for rat ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4185fe9-aa73-4faa-82ae-6e91e71043c3/documents/IUC5-ee779bca-2ba2-438d-8099-734f53a2b8d1_66e08ec7-3ada-4f45-96fd-736635d20419.html,,,,,, "1,4:3,6-dianhydro-D-glucitol",652-67-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4185fe9-aa73-4faa-82ae-6e91e71043c3/documents/IUC5-ee779bca-2ba2-438d-8099-734f53a2b8d1_66e08ec7-3ada-4f45-96fd-736635d20419.html,,oral,LD50,"2,000 mg/kg bw",, "1,4:3,6-dianhydro-D-glucitol",652-67-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4185fe9-aa73-4faa-82ae-6e91e71043c3/documents/IUC5-ee779bca-2ba2-438d-8099-734f53a2b8d1_66e08ec7-3ada-4f45-96fd-736635d20419.html,,dermal,LD50,"2,000 mg/kg bw",, "Fatty acids, C8-10, diesters with 1,4:3,6-dianhydro-D-glucitol",1215036-04-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3c7225d-f814-4143-b212-09250729a7dd/documents/82d9f907-c846-43ae-835d-f9f2b214ca7b_d0e0001b-6f44-454b-b6cb-f8782c1ef2fc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,000 mg/kg bw/day",,rat "Esterification product of sunflower-oil fatty acids, with 1,4:3,6-dianhydro-D-glucitol",1818326-42-9, The oral LD50 is > 2000 mg/kg bw (with no mortality at this dose level). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53b33cfb-ea7f-43ef-9a84-18954b2f5e66/documents/dd9ec715-da52-4532-ac7a-d68d5fbe1aa5_b3ae1f56-0be3-44d3-9bc3-273353a98dd8.html,,,,,, Isooctadecanoic acid,30399-84-9,Based on read-across from a supporting substance (structural analogue) following a category approach:Oral: NOAEL (rat) = 741 (male) and 855 (female) mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a4148e7-124e-48e1-9416-99444e4bc90d/documents/IUC5-c3cc5151-aa60-4088-862c-d528b0ebe8d0_8bdec342-8998-44a4-9c2b-a668a7ebbbca.html,,,,,, Isooctadecanoic acid,30399-84-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a4148e7-124e-48e1-9416-99444e4bc90d/documents/IUC5-c3cc5151-aa60-4088-862c-d528b0ebe8d0_8bdec342-8998-44a4-9c2b-a668a7ebbbca.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,741 mg/kg bw/day,,rat Isooctadecanoic acid,30399-84-9,Oral: LD50 (rat) > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a4148e7-124e-48e1-9416-99444e4bc90d/documents/IUC5-f3b6f170-d7ac-4824-93d7-78180a9ece85_8bdec342-8998-44a4-9c2b-a668a7ebbbca.html,,,,,, Isooctadecanoic acid,30399-84-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a4148e7-124e-48e1-9416-99444e4bc90d/documents/IUC5-f3b6f170-d7ac-4824-93d7-78180a9ece85_8bdec342-8998-44a4-9c2b-a668a7ebbbca.html,,oral,LD50,"2,000 mg/kg bw",, Isooctadecan-1-ol,27458-93-1,No repeated dose toxicity studies were available on Isostearyl aclohol by any route. Read across from a reliable 13 week study with Hexadecanol gave oral NOAEL of > 4257 mg/kg bw/day (Scientific Associates 1996a) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b1fe22f-723f-4046-8a71-4db24052362e/documents/IUC5-829ccac6-6f82-4c1a-bbd4-6920199ff054_62bdd4b3-94b7-42c6-a243-f0842eab9a56.html,,,,,, Isooctadecan-1-ol,27458-93-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b1fe22f-723f-4046-8a71-4db24052362e/documents/IUC5-829ccac6-6f82-4c1a-bbd4-6920199ff054_62bdd4b3-94b7-42c6-a243-f0842eab9a56.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"4,257 mg/kg bw/day",,rat Isooctadecan-1-ol,27458-93-1,"In an acute oral toxicity study conducted in accordance with OECD 401, a single oral administration of 2 g/kg (bw) Prisorine 3515 Iso Stearyl Aclohol was administered to 5 male and 5 female rats. No treatment related effects or mortality was reported under the conditions of this study. The LD50 is greater than 2 g/kg (bw) in the rat. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b1fe22f-723f-4046-8a71-4db24052362e/documents/IUC5-a59d8411-66f7-4680-9ed1-59ca699a929b_62bdd4b3-94b7-42c6-a243-f0842eab9a56.html,,,,,, Isooctadecan-1-ol,27458-93-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b1fe22f-723f-4046-8a71-4db24052362e/documents/IUC5-a59d8411-66f7-4680-9ed1-59ca699a929b_62bdd4b3-94b7-42c6-a243-f0842eab9a56.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Isooctadecan-1-ol,27458-93-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b1fe22f-723f-4046-8a71-4db24052362e/documents/IUC5-a59d8411-66f7-4680-9ed1-59ca699a929b_62bdd4b3-94b7-42c6-a243-f0842eab9a56.html,,dermal,LD50,"6,180 mg/kg bw",adverse effect observed, Isooctadecyl isooctadecanoate,41669-30-1,"Oral (OECD 422), rat: NOAEL (systemic):Females = 300 mg/kg bw/dayMales = ≥ 1000 mg/kg bw/dayOral (OECD 408), rat: NOAEL (systemic) = ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf0a30ff-0419-4f02-ab4a-a1c52ecde48c/documents/IUC5-24f89c8c-c8b2-40b9-9617-a737c0146286_f15973ce-0944-4150-8b5f-ec97db9847a0.html,,,,,, Isooctadecyl isooctadecanoate,41669-30-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf0a30ff-0419-4f02-ab4a-a1c52ecde48c/documents/IUC5-24f89c8c-c8b2-40b9-9617-a737c0146286_f15973ce-0944-4150-8b5f-ec97db9847a0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Isooctadecyl isooctadecanoate,41669-30-1,"Oral (OECD 401), rat: LD50 > 2000 mg/kg bw Inhalation (OECD 436), rat: LC50 > 5.7 mg/L air Dermal (OECD 402), rabbit: LD50 > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf0a30ff-0419-4f02-ab4a-a1c52ecde48c/documents/IUC5-bd61fa8e-08fa-48a9-aca5-cdb78e92e89a_f15973ce-0944-4150-8b5f-ec97db9847a0.html,,,,,, Isooctadecyl pivalate,58958-60-4,"Oral: OECD 408, rat, NOAEL ≥ 3460 mg/kg bw/day (calculated from 4.0 mL/kg bw, based on a density of 0.865 g/mL) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76b3482a-2ae8-4f40-a03f-fc7eaf50d1dc/documents/IUC5-6b4754f9-17e0-4b9e-a71e-8e4a6466e793_be8b4a21-d6bf-4339-b03c-bd9d5d30848e.html,,,,,, Isooctadecyl pivalate,58958-60-4,Oral (OECD 401): LD50 > 5000 mg/kg bw Inhalation (OECD 436): LC50 > 5.3 mg/L (read-across)Dermal (OECD 402): LD50 > 2000 mg/kg bw (read-across) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76b3482a-2ae8-4f40-a03f-fc7eaf50d1dc/documents/IUC5-e32a9731-04c1-4288-9fa1-ad413714e5b3_be8b4a21-d6bf-4339-b03c-bd9d5d30848e.html,,,,,, Isooctadecyl palmitate,72576-80-8,NOAEL systemic= 300 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/81b8c2ee-a79f-413b-87e3-2bdd133b5e3f/documents/IUC5-5ebc1a53-527b-484d-b6cf-fd1242616a5d_5d64f48f-ec19-4f42-9ccd-eec430a01a79.html,,,,,, Isooctadecyl palmitate,72576-80-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/81b8c2ee-a79f-413b-87e3-2bdd133b5e3f/documents/IUC5-5ebc1a53-527b-484d-b6cf-fd1242616a5d_5d64f48f-ec19-4f42-9ccd-eec430a01a79.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Isooctadecyl palmitate,72576-80-8,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81b8c2ee-a79f-413b-87e3-2bdd133b5e3f/documents/IUC5-b978fe4c-1f67-4f16-bed5-0f50fbcbb1bd_5d64f48f-ec19-4f42-9ccd-eec430a01a79.html,,,,,, Isotridecan-1-ol,27458-92-0,"90 -day, rat: NOAEL = 150mg/kg bw/d, based on effects on body weight, clinical chemistry and urinanalysis, excluding peroxisome proliferation (BASF 1996, OECD 408, GLP) - data generated for CAS 10042 -59 -8 In support, the NOAEL in an OECD 422 (BASF, 2023) was 250 mg/kg bw/d for systemic toxicicty based on effects on clinical chemistry, organ weights and histopathology. Further, 14 -day screening, male rats (Rhodes et al., 1983):no effects on testes, liver, and body weight at 1mM/kg b.w.NOAEL = 184 mg/kg bw (Isotridecanol, CAS 27458 -92 -0)NOAEL = 168 mg/kg bw (Isodecanol, CAS 25339 -17 -7) NOAEL = 144 mg/kg bw (Isononanol, CAS 27458 -94 -2) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edf4f1ad-150b-48b2-9dab-391a114e6f8f/documents/IUC5-a562da37-dfe7-427f-ab29-dbd2b7938ce0_984ffab5-2adf-4c72-9570-2baa77a59a35.html,,,,,, Isotridecan-1-ol,27458-92-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edf4f1ad-150b-48b2-9dab-391a114e6f8f/documents/IUC5-a562da37-dfe7-427f-ab29-dbd2b7938ce0_984ffab5-2adf-4c72-9570-2baa77a59a35.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Isotridecan-1-ol,27458-92-0,"- acute oral: rat (male/female): LD50 > 2000 mg/kg bw (BASF, 2002) rat (male): LD50 = 17.2 ml/kg bw (ca. 14500 mg/kg bw; Smyth, H.F. et al., 1962)mouse (m/f): LD50 > 5395 mg/kg (BASF, 1963) - acute inhalation:rat (male/female), IRT: LC0 >/= 0.3 mg/l (BASF, 1963)rat, IRT: LC0 >/= 0.0064 mg/l (Smyth, H.F. et al., 1962)rat, IRT: LC0 >=0.006mg/l (calculated sat. vapor conc., Scala, 1973) - acute dermal:rabbits (male): LD50 = 7.07 ml/kg bw (ca. 5960 mg/kg bw; Smyth, H.F. et al., 1962)rabbits: LD50 > 2600 mg/kg bw (Scala, R.A. and Burtis, E.G., 1973) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edf4f1ad-150b-48b2-9dab-391a114e6f8f/documents/IUC5-ace6040b-4e02-4da3-9ba9-fd800401a797_984ffab5-2adf-4c72-9570-2baa77a59a35.html,,,,,, Isotridecan-1-ol,27458-92-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edf4f1ad-150b-48b2-9dab-391a114e6f8f/documents/IUC5-ace6040b-4e02-4da3-9ba9-fd800401a797_984ffab5-2adf-4c72-9570-2baa77a59a35.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Isotridecan-1-ol,27458-92-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edf4f1ad-150b-48b2-9dab-391a114e6f8f/documents/IUC5-ace6040b-4e02-4da3-9ba9-fd800401a797_984ffab5-2adf-4c72-9570-2baa77a59a35.html,,dermal,LD50,"5,960 mg/kg bw",no adverse effect observed, Isotridecan-1-ol,27458-92-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edf4f1ad-150b-48b2-9dab-391a114e6f8f/documents/IUC5-ace6040b-4e02-4da3-9ba9-fd800401a797_984ffab5-2adf-4c72-9570-2baa77a59a35.html,,inhalation,discriminating conc.,0 mg/m3,no adverse effect observed, "Isotridecyl 3,5,5-trimethylhexanoate",59231-37-7, Study performed to recognised testing guideline and GLP. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe89ccc9-79bd-4d76-a361-088057f40d36/documents/9074673c-55ab-49a5-a60c-ef5c1c8908d2_9ef1be2d-b82f-43b2-9aeb-8eeefd5d74b8.html,,,,,, "Isotridecyl 3,5,5-trimethylhexanoate",59231-37-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe89ccc9-79bd-4d76-a361-088057f40d36/documents/9074673c-55ab-49a5-a60c-ef5c1c8908d2_9ef1be2d-b82f-43b2-9aeb-8eeefd5d74b8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Isotridecyl 3,5,5-trimethylhexanoate",59231-37-7, Studies performed in accordance with recognised testing guidelines. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe89ccc9-79bd-4d76-a361-088057f40d36/documents/58ee9bb3-819c-45f8-ab17-1a4bf6c40c50_9ef1be2d-b82f-43b2-9aeb-8eeefd5d74b8.html,,,,,, 11-methyldodecyl laurate,94134-83-5," Read-across from supporting substance (structural analogue). The experimental data obtained by testing 8-methylnonyl octadec-9-enoate can be reliably extrapolated (by read-across) to 11-methyldodecyl laurate and support the absence of repeated dose toxicity effect. Overall, 11-methyldodecyl laurate should not be classified for repeated dose toxicity in accordance with Regulation (EC) n. 1272/2008. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30f67812-d530-424c-8792-0dbf5a2396b5/documents/a7953371-8ebe-4eb2-a85c-c304f61f4e9d_69039154-01b7-4f50-85a9-3dcbf44b5dc6.html,,,,,, 11-methyldodecyl laurate,94134-83-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30f67812-d530-424c-8792-0dbf5a2396b5/documents/a7953371-8ebe-4eb2-a85c-c304f61f4e9d_69039154-01b7-4f50-85a9-3dcbf44b5dc6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 11-methyldodecyl laurate,94134-83-5, The acute oral median lethal dose of 11-methyldodecyl laurate in Wistar rats was found to be > 2000 mg/kg body weight. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30f67812-d530-424c-8792-0dbf5a2396b5/documents/0766a80b-9f22-412f-9497-e91ffef6bfa9_69039154-01b7-4f50-85a9-3dcbf44b5dc6.html,,,,,, 11-methyldodecyl laurate,94134-83-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30f67812-d530-424c-8792-0dbf5a2396b5/documents/0766a80b-9f22-412f-9497-e91ffef6bfa9_69039154-01b7-4f50-85a9-3dcbf44b5dc6.html,,oral,LD50,"5,000 mg/kg bw",adverse effect observed, Isovaleric acid,503-74-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): sufficient ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e65e2594-40b8-4556-a850-f4578a40ebfa/documents/d86cdabd-da32-49de-a138-ecf5f2dbcb22_46dca03d-f9ce-495c-a156-1dbd2d128f21.html,,,,,, Isovaleric acid,503-74-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e65e2594-40b8-4556-a850-f4578a40ebfa/documents/d86cdabd-da32-49de-a138-ecf5f2dbcb22_46dca03d-f9ce-495c-a156-1dbd2d128f21.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"4,100 mg/kg bw/day",,rat Isovaleric acid,503-74-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): suitable for assessment Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): suitable for assessment Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): suitable for assessment. Local effects on skin described. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e65e2594-40b8-4556-a850-f4578a40ebfa/documents/71123b77-1f36-4dac-9387-f478d8e36495_46dca03d-f9ce-495c-a156-1dbd2d128f21.html,,,,,, Isovaleric acid,503-74-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e65e2594-40b8-4556-a850-f4578a40ebfa/documents/71123b77-1f36-4dac-9387-f478d8e36495_46dca03d-f9ce-495c-a156-1dbd2d128f21.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, Isovaleric acid,503-74-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e65e2594-40b8-4556-a850-f4578a40ebfa/documents/71123b77-1f36-4dac-9387-f478d8e36495_46dca03d-f9ce-495c-a156-1dbd2d128f21.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Isovaleric acid,503-74-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e65e2594-40b8-4556-a850-f4578a40ebfa/documents/71123b77-1f36-4dac-9387-f478d8e36495_46dca03d-f9ce-495c-a156-1dbd2d128f21.html,,inhalation,LC50,"2,060 mg/m3",no adverse effect observed, Itaconic acid,97-65-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4e12b1e-6558-43cc-a561-50a4058357f5/documents/IUC5-329e8278-ab79-4dbd-bdc3-e386c4c7851f_0f1234c6-eb84-4937-ac88-a92b22a695bb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,001 mg/kg bw/day",,rat Itaconic acid,97-65-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4e12b1e-6558-43cc-a561-50a4058357f5/documents/IUC5-80378072-6b70-4bde-94c1-967e6a83c330_0f1234c6-eb84-4937-ac88-a92b22a695bb.html,,oral,LD50,"2,969 mg/kg bw",, Tetrahydro-3-pentyl-2H-pyran-4-yl acetate,18871-14-2,For the read-across substance Florosa a dermal 90-day repeated dose toxicity test is available with a NOAEL of >=1000 mg/kg bw/day which does not lead to classification and labelling for this endpoint. Jasmal is expected to metabolise in a metabolite similar to Florosa. Therefore the Florosa NOAEL of >=1000 mg/kg bw/day in the 90-day dermal repeated doses toxicity can be used for read-across to Jasmal. The result of the 90-day dermal toxicity study overrules the Florosa 28-oral gavage study with a NOAEL of 125 mg/kg bw. This is because when the NOAEL of the 90-dermal toxicity study is converted to the oral route using the experimental dermal absorption value of 18% the NOAEL is >=180 mg/kg bw on which bases it can be assumed that the effects seen in the 28-day oral gavage study do not have to be considered adverse. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7df9461-0858-4d75-8ded-9e55dd5d6864/documents/IUC5-85e9f210-6ab0-4b03-b128-69da1cba6d73_0418e0a2-3dfa-47d6-8354-a950920f3f42.html,,,,,, Tetrahydro-3-pentyl-2H-pyran-4-yl acetate,18871-14-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7df9461-0858-4d75-8ded-9e55dd5d6864/documents/IUC5-85e9f210-6ab0-4b03-b128-69da1cba6d73_0418e0a2-3dfa-47d6-8354-a950920f3f42.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat Tetrahydro-3-pentyl-2H-pyran-4-yl acetate,18871-14-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7df9461-0858-4d75-8ded-9e55dd5d6864/documents/IUC5-85e9f210-6ab0-4b03-b128-69da1cba6d73_0418e0a2-3dfa-47d6-8354-a950920f3f42.html,Repeated dose toxicity – local effects,dermal,NOAEL,"1,000 ",no adverse effect observed,rat Tetrahydro-3-pentyl-2H-pyran-4-yl acetate,18871-14-2, Acute oral toxicity: OECD TG 401: > 5000 mg/kg bw. Acute inhalation toxicity derived from acute oral toxicity: > 13000 mg/m3 Acute dermal toxicity: OECD TG 402: >2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7df9461-0858-4d75-8ded-9e55dd5d6864/documents/IUC5-e2fad2ac-bcab-4762-9724-306e198cea7b_0418e0a2-3dfa-47d6-8354-a950920f3f42.html,,,,,, "Juniper, Juniperus communis, ext.",84603-69-0," Oral LD50 (male and female rats) > 5000 mg/kg bw (K, Rel.2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c44f6608-501c-41b6-aba7-886b755a0023/documents/9e3a4992-7954-441e-86b4-7b026f2b1921_c7bbbb67-2ac5-4a40-9e3b-5c58cacc29dc.html,,,,,, "Juniper, Juniperus communis, ext.",84603-69-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c44f6608-501c-41b6-aba7-886b755a0023/documents/9e3a4992-7954-441e-86b4-7b026f2b1921_c7bbbb67-2ac5-4a40-9e3b-5c58cacc29dc.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Juniper, Juniperus mexicana, ext., epoxidized",99811-75-3,"Acute toxicity: oral: LD50 > 5000 mg/kg bw (Study performed similarly to standard guidelines in rats, K, rel.2) ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f49d91d-a41d-4fb4-8a17-b536898ede9f/documents/IUC5-f1b83908-9809-4fc0-921c-6f095330ac0f_33436ba2-a239-4912-8a39-256e20f5a8a4.html,,,,,, "Juniper, Juniperus mexicana, ext., epoxidized",99811-75-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f49d91d-a41d-4fb4-8a17-b536898ede9f/documents/IUC5-f1b83908-9809-4fc0-921c-6f095330ac0f_33436ba2-a239-4912-8a39-256e20f5a8a4.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Juniper, Juniperus mexicana, ext.",91722-61-1," Repeated dose toxicity (OECD TG 422): 207 mg/kg bw/day (1500 ppm), based on reduced food consumption of females throughout gestation and lactation at 5000 ppm. (read across from Cedarwood Oil Virginia) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12410334-f859-4d4d-a438-cbe42d2320c9/documents/7e149273-06f9-468f-978e-8f867bc9d3f1_829d7e8b-2a55-4123-b7fb-8bd49ee2b2c9.html,,,,,, "Juniper, Juniperus mexicana, ext.",91722-61-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12410334-f859-4d4d-a438-cbe42d2320c9/documents/7e149273-06f9-468f-978e-8f867bc9d3f1_829d7e8b-2a55-4123-b7fb-8bd49ee2b2c9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,207 mg/kg bw/day,,rat "Juniper, Juniperus mexicana, ext.",91722-61-1, Acute oral toxicity (similar to OECD TG 401): LD50 >5000 mg/kg bw Acute dermal toxicity (similar to OECD TG 402): LD50 >5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12410334-f859-4d4d-a438-cbe42d2320c9/documents/a7066bcb-6588-415e-b608-a5cdcba74fcb_829d7e8b-2a55-4123-b7fb-8bd49ee2b2c9.html,,,,,, "Juniper, Juniperus oxycedrus, ext.",90046-02-9,"Acute toxicity, oral, similar to OECD guideline 401, rats: LD50 = 8014 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c1eb42e-b202-484d-b810-098086b87069/documents/IUC5-dee98ce8-ac2e-4f43-b1f0-1949d2c7df94_d482479b-b251-40bf-927f-5fcc89a0a28a.html,,,,,, "Juniper, Juniperus oxycedrus, ext.",90046-02-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c1eb42e-b202-484d-b810-098086b87069/documents/IUC5-dee98ce8-ac2e-4f43-b1f0-1949d2c7df94_d482479b-b251-40bf-927f-5fcc89a0a28a.html,,oral,LD50,"8,014 mg/kg bw",no adverse effect observed, "Juniper, Juniperus virginiana, ext.",85085-41-2," Repeated dose toxicity (OECD TG 422): NOAEL = 207 mg/kg bw/day (1500 ppm), based on reduced food consumption of females throughout gestation and lactation at 5000 ppm. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d373a93-35d0-4459-a324-b99ad2a4c0be/documents/7b0e5c2e-e867-4843-a648-0c54b06786e1_2861426e-7cc1-40f2-b240-c5660f16772b.html,,,,,, "Juniper, Juniperus virginiana, ext.",85085-41-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d373a93-35d0-4459-a324-b99ad2a4c0be/documents/7b0e5c2e-e867-4843-a648-0c54b06786e1_2861426e-7cc1-40f2-b240-c5660f16772b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,207 mg/kg bw/day,,rat "Juniper, Juniperus virginiana, ext.",85085-41-2," Acute oral toxicity: pre- GLP, similar to OECD 401, single dose by gavage, male Wistar rat, LD50> 5000 mg/kg bw. Acute dermal toxicity: pre- GLP, similar to OECD 402, single dose by gavage, female New Zeland white rabbit, LD50> 5000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d373a93-35d0-4459-a324-b99ad2a4c0be/documents/IUC5-49805dea-db2d-45d1-baf9-6b4ad7e85427_2861426e-7cc1-40f2-b240-c5660f16772b.html,,,,,, "Juniper, Juniperus virginiana, ext.",85085-41-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d373a93-35d0-4459-a324-b99ad2a4c0be/documents/IUC5-49805dea-db2d-45d1-baf9-6b4ad7e85427_2861426e-7cc1-40f2-b240-c5660f16772b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Juniper, Juniperus virginiana, ext.",85085-41-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d373a93-35d0-4459-a324-b99ad2a4c0be/documents/IUC5-49805dea-db2d-45d1-baf9-6b4ad7e85427_2861426e-7cc1-40f2-b240-c5660f16772b.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "4-(1-ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone",36306-87-3," In conclusion, treatment with Kephalis by dietary inclusion in male and female Wistar Han rats at dose levels of 1500, 5000 and 15000 ppm revealed parental toxicity at 5000 and 15000 ppm. When corrected for mean test article intake, the parental NOAEL of 1500 ppm corresponds to 97-103 mg/kg for males and 127-175 mg/kg for females. Thus, the worse case scenario is for male animals with a NOAEL of 97 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0c06e77-ca2e-458b-8f57-b93417f3403e/documents/87c331f4-3864-4ae5-99a4-f8785bf847f2_2a5c9d73-3712-4040-b0db-8a4e06cc593e.html,,,,,, "4-(1-ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone",36306-87-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0c06e77-ca2e-458b-8f57-b93417f3403e/documents/87c331f4-3864-4ae5-99a4-f8785bf847f2_2a5c9d73-3712-4040-b0db-8a4e06cc593e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,97 mg/kg bw/day,,rat "4-(1-ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone",36306-87-3," The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. The test item does not meet the criteria for classification according to Regulation (EC) No 1272/2008, relating to the Classification, Labeling and Packaging of Substances and Mixtures. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0c06e77-ca2e-458b-8f57-b93417f3403e/documents/d07bff8b-790d-46e4-92f2-2a29e661d992_2a5c9d73-3712-4040-b0db-8a4e06cc593e.html,,,,,, "4-(1-ethoxyvinyl)-3,3,5,5-tetramethylcyclohexanone",36306-87-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0c06e77-ca2e-458b-8f57-b93417f3403e/documents/d07bff8b-790d-46e4-92f2-2a29e661d992_2a5c9d73-3712-4040-b0db-8a4e06cc593e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-oxoglutaric acid,328-50-7," Non-GLP, non-OECD compliant study, rats (Wistar), male/female, oral: gavage, doses: 2.0, 4.0, 5.0 and 10.00 g/kg bw, LD50 > 5.0 g/kg bw. Non-GLP, non-OECD compliant study, rats (Wistar), female, oral: gavage, doses: 0.5, 1.0, 2.0, 3.5 and 4.0 g/kg bw., reduction of cyanide mortality by 50% at 2.0 g/kg bw. administered 10 min prior to poisoning. In the same study: rats (Wistar), female, intraperitoneal, doses: 1.0, 2.0, 4.0 g/kg bw., adverse effects observed at 4.0 g/kg bw., LD 50 > 2.0 g/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52575054-76a3-4e91-b710-d90e8889e0f5/documents/22e64da9-7441-4afb-a649-ee030f60c7f3_9a251c9c-241a-459f-8f04-b3dac6463a33.html,,,,,, 2-oxoglutaric acid,328-50-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52575054-76a3-4e91-b710-d90e8889e0f5/documents/22e64da9-7441-4afb-a649-ee030f60c7f3_9a251c9c-241a-459f-8f04-b3dac6463a33.html,,oral,LD50,"5,000 mg/kg bw",adverse effect observed, "(1S,5S)-2,6,6-trimethylbicyclo[3.1.1]hept-2-ene",7785-26-4,"In a Preliminary Toxicity Study, the systemic toxic potential of the registered substance was assessed in a 21-day oral study (dietary administration) in Sprague-Dawley rats to aid in the selection of a suitable high dose for a subsequent OECD 421 screening study. Based on the results of this study, it was concluded that the effects observed at the high dose of 12000 ppm do not preclude the use of this dose level as the high dose for the main OECD 421 study. In a GLP and OECD 413 compliant 90-day repeated dose toxicity study by inhalation with the registered substance, the No Observed Adverse Effect Concentration (NOAEC) was considered to be 0.3 mg/L, based on the two females decedents at the concentration level of 0.9 mg/L due to general poor clinical condition. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): GLP and OECD guideline compliant study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): GLP and OECD guideline compliant study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Preliminary study ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e353b38-205c-437b-b7d8-ce720978231c/documents/aa88f019-3886-4033-9db3-9b8b51397e1f_a1722120-40ae-4b93-9120-01a863ebafa9.html,,,,,, "(1S,5S)-2,6,6-trimethylbicyclo[3.1.1]hept-2-ene",7785-26-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e353b38-205c-437b-b7d8-ce720978231c/documents/aa88f019-3886-4033-9db3-9b8b51397e1f_a1722120-40ae-4b93-9120-01a863ebafa9.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,300 mg/m3,,rat "(1S,5S)-2,6,6-trimethylbicyclo[3.1.1]hept-2-ene",7785-26-4, In a GLP study conducted on alpha-pinene multiconstituent according to the OECD 423 guideline the oral LD50 cut-off value (rats) was 500 mg/kg bw. In a GLP study conducted on alpha-pinene multiconstituent according to the OECD 402 guideline the dermal LD50 (rats) was higher than 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e353b38-205c-437b-b7d8-ce720978231c/documents/9bd5b63a-55ed-43a8-a179-d18eaf7b91c4_a1722120-40ae-4b93-9120-01a863ebafa9.html,,,,,, "(1S,5S)-2,6,6-trimethylbicyclo[3.1.1]hept-2-ene",7785-26-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e353b38-205c-437b-b7d8-ce720978231c/documents/9bd5b63a-55ed-43a8-a179-d18eaf7b91c4_a1722120-40ae-4b93-9120-01a863ebafa9.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "(1S,5S)-2,6,6-trimethylbicyclo[3.1.1]hept-2-ene",7785-26-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e353b38-205c-437b-b7d8-ce720978231c/documents/9bd5b63a-55ed-43a8-a179-d18eaf7b91c4_a1722120-40ae-4b93-9120-01a863ebafa9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, L-menthan-3-one,14073-97-3,Read-across compound DL-menthol is not toxic in rats when applied daily by oral (feed) at a dose of 375 mg/kg bw/day for 103 weeks (data derived to L-menthan-3-one NOEL = 370 mg/kg bw/day). ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/159db648-c8b5-435c-b317-c34eea83dad4/documents/IUC5-824df771-d043-4124-8f98-39c35c6765f2_e71b65d0-9cea-41d4-a09a-d58261179803.html,,,,,, L-menthan-3-one,14073-97-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/159db648-c8b5-435c-b317-c34eea83dad4/documents/IUC5-824df771-d043-4124-8f98-39c35c6765f2_e71b65d0-9cea-41d4-a09a-d58261179803.html,Chronic toxicity – systemic effects,oral,NOAEL,370 mg/kg bw/day,,rat L-menthan-3-one,14073-97-3,"Oral: LD50 > 2000 mg/kg body weight, leading to not classification according to CLP.Dermal: LD50 (Isomenthone) > 5 mL/kg body weight (> 4473 mg/kg bw), leading to not classification according to CLP.Inhalation: no information available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/159db648-c8b5-435c-b317-c34eea83dad4/documents/IUC5-aeace121-4ed7-448e-a6a9-01a3082c88b5_e71b65d0-9cea-41d4-a09a-d58261179803.html,,,,,, L-menthan-3-one,14073-97-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/159db648-c8b5-435c-b317-c34eea83dad4/documents/IUC5-aeace121-4ed7-448e-a6a9-01a3082c88b5_e71b65d0-9cea-41d4-a09a-d58261179803.html,,oral,LD50,"2,046 mg/kg bw",no adverse effect observed, Lactic acid,50-21-5," There are no reliable studies available for the assessment of the repeated dose toxicity endpoint with the target substance, lactic acid. Therefore, available data from an oral subchronic repeated dose toxicity study conducted with a suitable read-across partner, calcium lactate was used to assess the specific target organ toxicity of the target substance. Based on the results, no classification for specific target organ toxicity is warranted for lactic acid. For details and justification of read-across please refer to the report attached in section 13 of IUCLID. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/496f3271-976b-4515-aaf1-1dd6bb8034c3/documents/IUC5-66247a55-8067-4971-b41d-7f7a450336f2_a36638f9-61e0-4cf4-b1ea-474ae95f9166.html,,,,,, Lactic acid,50-21-5," There are no studies available for the assessment of the oral, inhalation and dermal acute toxicity for the target substance lactic acid. Therefore,data available from the suitable read-across substance L(+)-lactic acid was used to assess the acute toxicity via the standard routes of administration (oral, inhalation, dermal). In all studies, the obtained LD50 or LC50 values for the oral, dermal or inhalation route are above the limit values of the relevant OECD guidelines. Thus, no classification for acute toxicity is warranted. For details and justification of read-across please refer to the report attached in section 13 of IUCLID. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/496f3271-976b-4515-aaf1-1dd6bb8034c3/documents/IUC5-389b5de5-3264-456d-b2da-2d2cd45b1658_a36638f9-61e0-4cf4-b1ea-474ae95f9166.html,,,,,, Lactic acid,50-21-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/496f3271-976b-4515-aaf1-1dd6bb8034c3/documents/IUC5-389b5de5-3264-456d-b2da-2d2cd45b1658_a36638f9-61e0-4cf4-b1ea-474ae95f9166.html,,oral,LD50,"3,543 mg/kg bw",adverse effect observed, Lactic acid,50-21-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/496f3271-976b-4515-aaf1-1dd6bb8034c3/documents/IUC5-389b5de5-3264-456d-b2da-2d2cd45b1658_a36638f9-61e0-4cf4-b1ea-474ae95f9166.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Lactic acid,50-21-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/496f3271-976b-4515-aaf1-1dd6bb8034c3/documents/IUC5-389b5de5-3264-456d-b2da-2d2cd45b1658_a36638f9-61e0-4cf4-b1ea-474ae95f9166.html,,inhalation,LC50,> 7.94 mg/L,adverse effect observed, Dilactide,95-96-5,"Lactide (18:1 mixture of L-lactide and m-lactide) was tested in dogs in a 2 week dose range finding study and a subsequent 90-day full study conducted similar to OECD TG 408. The primary toxic effect was irritation of the gastrointestinal tract at 100 mg/kg bw/day in the 90-day study. Lactide is a suitable read across partner as dilactide is a mixture of D- and L-lactide isomers. In addition, an oral subchronic repeated dose toxicity study conducted with a suitable read-across partner, calcium lactate was used to assess the specific target organ toxicity of the target substance. Based on the results, no classification for specific target organ toxicity is warranted for dilactide. In addition,in an oral subchronic repeated dose toxicity study conducted with a suitable read-across partner, calcium lactate was used to assess the specific target organ toxicity of the target substance. Based on the results, no classification for specific target organ toxicity is warranted for D-lactide. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bdec418-5f7e-4658-8809-fce85d0017e7/documents/IUC5-e1abccd1-7f81-4cd4-a512-5ef88d3784e5_95fbf02e-d1b7-4b68-a887-9659af1e99ba.html,,,,,, Dilactide,95-96-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bdec418-5f7e-4658-8809-fce85d0017e7/documents/IUC5-e1abccd1-7f81-4cd4-a512-5ef88d3784e5_95fbf02e-d1b7-4b68-a887-9659af1e99ba.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,dog Dilactide,95-96-5," There are no studies available for the assessment of the oral, inhalation and dermal acute toxicity for the target substance dilactide. Therefore, data available from the suitable read-across substance L(+)-lactic acid, D-lactide and L-lactide was used to assess the acute toxicity via the standard routes of administration (oral, inhalation, dermal). A sample of D-lactide (purity >99.5%) was examined for acute oral toxicity in an experiment conducted according to OECD guideline 423 with female rats. A dose level of 2000 mg/kg bw was examined. No mortality or distinct clinical signs were observed after treatment of 6 females with 2000 mg/kg bw. In an acute dermal toxicity study, a group of young adult Wistar rats (5 males and 5 females) were dermally exposed to D-lactide (purity 99%) in polyethylene glycol 400 for 24 hours to approximately 10% of body surface area at 2000 mg/kg bw. Animals were observed for 14 days. No mortality occurred. There were no treatment related clinical signs, necropsy findings or changes in body weight. In addition, L-lactide was examined in an acute oral toxicity test and in an acute dermal toxicity study. In both GLP guideline studies no effects were observed after treatment with 2000 mg/kg bw . D- and L-lactide are suitable read across partners as Dilactide is a mixture of D- and L-lactide isomers. L(+)-lactic acid is used additionally as a read-across partner for dilactide in an acute inhalation toxicity study (OECD TG 403) in rats, in which a LC50 of > 7.94 mg/L was determined. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bdec418-5f7e-4658-8809-fce85d0017e7/documents/IUC5-77694c07-a28b-4299-bf39-4e2c46132fd5_95fbf02e-d1b7-4b68-a887-9659af1e99ba.html,,,,,, Dilactide,95-96-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bdec418-5f7e-4658-8809-fce85d0017e7/documents/IUC5-77694c07-a28b-4299-bf39-4e2c46132fd5_95fbf02e-d1b7-4b68-a887-9659af1e99ba.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Dilactide,95-96-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bdec418-5f7e-4658-8809-fce85d0017e7/documents/IUC5-77694c07-a28b-4299-bf39-4e2c46132fd5_95fbf02e-d1b7-4b68-a887-9659af1e99ba.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Dilactide,95-96-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bdec418-5f7e-4658-8809-fce85d0017e7/documents/IUC5-77694c07-a28b-4299-bf39-4e2c46132fd5_95fbf02e-d1b7-4b68-a887-9659af1e99ba.html,,inhalation,LC50,> 7.94 mg/L,adverse effect observed, "Fatty acids, lanolin",68424-43-1,"Oral: NOAEL (rat, 90d, OECD 408) ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb25af73-073a-473f-9fde-77eec7e263a2/documents/IUC5-deb7026d-a07a-41ff-832a-1d9298557a42_025953b1-d890-4563-bf2e-b391dc2dcd84.html,,,,,, "Fatty acids, lanolin",68424-43-1,"Acute oral toxicity: LD50 > 5000 mg/kg bw, similar to OECD Guideline 401, no GLPAcute dermal toxicity: LD50 > 2000 mg/kg bw, according to OECD Guideline 402, GLP compliantAcute inhalation toxicity: data waiving ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb25af73-073a-473f-9fde-77eec7e263a2/documents/IUC5-486e4eab-1c7e-43e5-8138-55f0d777acd2_025953b1-d890-4563-bf2e-b391dc2dcd84.html,,,,,, "Fatty acids, lanolin",68424-43-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb25af73-073a-473f-9fde-77eec7e263a2/documents/IUC5-486e4eab-1c7e-43e5-8138-55f0d777acd2_025953b1-d890-4563-bf2e-b391dc2dcd84.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Fatty acids, lanolin",68424-43-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb25af73-073a-473f-9fde-77eec7e263a2/documents/IUC5-486e4eab-1c7e-43e5-8138-55f0d777acd2_025953b1-d890-4563-bf2e-b391dc2dcd84.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Alcohols, lanolin",8027-33-6,"Oral, sub-chronic exposure: NOAEL systemic toxicity (OECD 408, rat, m/f): ≥ 1000 mg/kg bw/day (corresponding to the highest dose tested)     ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b58ffe1-10df-430f-8e12-901467b86718/documents/6af89160-4be5-4fd3-b0c5-7f0c6670230e_acfb5023-c3ba-46c2-bf12-34070657b294.html,,,,,, "Alcohols, lanolin",8027-33-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b58ffe1-10df-430f-8e12-901467b86718/documents/6af89160-4be5-4fd3-b0c5-7f0c6670230e_acfb5023-c3ba-46c2-bf12-34070657b294.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat "Alcohols, lanolin",8027-33-6,"Acute oral toxicity: OECD 401 (rat, m/f): LD50 > 2000 mg/kg bw   Acute dermal toxicity: OECD 402 (rat, m/f): LD50 > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b58ffe1-10df-430f-8e12-901467b86718/documents/e998b0bb-e4d6-486c-b67d-f55053686128_acfb5023-c3ba-46c2-bf12-34070657b294.html,,,,,, "Alcohols, lanolin",8027-33-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b58ffe1-10df-430f-8e12-901467b86718/documents/e998b0bb-e4d6-486c-b67d-f55053686128_acfb5023-c3ba-46c2-bf12-34070657b294.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alcohols, lanolin",8027-33-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b58ffe1-10df-430f-8e12-901467b86718/documents/e998b0bb-e4d6-486c-b67d-f55053686128_acfb5023-c3ba-46c2-bf12-34070657b294.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Lanthanum chloride, anhydrous",10099-58-8,Oral: NOAEL (rat) ≥ 738 mg/kg bw/d ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ec0666b-a893-4d55-8571-48a466a2f99d/documents/IUC5-134f5541-17dd-42cf-9a31-4b38c17da468_214c2569-bd91-4515-a769-cd27acac06f5.html,,,,,, "Lanthanum chloride, anhydrous",10099-58-8,"oral: LD50 (rat) = 2621 mg/kg bw Lanthanum chloride, anhydrous (original value: 3200 mg/kg bw Lanthanum chloride trihydrate)dermal: LD50 (rabbit) > 1638 mg/kg bw Lanthanum chloride, anhydrous ((original value: > 2000 mg/kg bw Lanthanum chloride trihydrate) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ec0666b-a893-4d55-8571-48a466a2f99d/documents/IUC5-9806f493-548c-4e35-8ba2-51b241ccbe9c_214c2569-bd91-4515-a769-cd27acac06f5.html,,,,,, Dodecanal,112-54-9,"Repeated dose toxicity: via oral route: NOAEL = 20000 ppm (eq. 1409.7 mg/kg bw/day) (OECD 408, GLP, K, Rel.1)     ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c363f4eb-9605-4b58-b86f-1098a8e2cc0c/documents/IUC5-96e846d6-2da0-4838-a223-412503217633_1b0e4b33-414f-41eb-b661-41eaaeea0924.html,,,,,, Dodecanal,112-54-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c363f4eb-9605-4b58-b86f-1098a8e2cc0c/documents/IUC5-96e846d6-2da0-4838-a223-412503217633_1b0e4b33-414f-41eb-b661-41eaaeea0924.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dodecanal,112-54-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c363f4eb-9605-4b58-b86f-1098a8e2cc0c/documents/IUC5-96e846d6-2da0-4838-a223-412503217633_1b0e4b33-414f-41eb-b661-41eaaeea0924.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,409.7 mg/kg bw/day",,rat Dodecanal,112-54-9,"Acute toxicity via Oral route: LD50 = 23100 mg/kg bw (eq. OECD 401, non-GLP, K, Rel.2). Acute toxicity via Dermal route: > 2000 mg/kg bw (eq. OECD 402, non-GLP, K, Rel.2). Acute toxicity via Inhalation route: No study available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c363f4eb-9605-4b58-b86f-1098a8e2cc0c/documents/IUC5-ea5f386d-e505-419e-82a8-a948db329efc_1b0e4b33-414f-41eb-b661-41eaaeea0924.html,,,,,, Dodecanal,112-54-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c363f4eb-9605-4b58-b86f-1098a8e2cc0c/documents/IUC5-ea5f386d-e505-419e-82a8-a948db329efc_1b0e4b33-414f-41eb-b661-41eaaeea0924.html,,oral,LD50,"23,100 mg/kg bw",no adverse effect observed, Dodecanal,112-54-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c363f4eb-9605-4b58-b86f-1098a8e2cc0c/documents/IUC5-ea5f386d-e505-419e-82a8-a948db329efc_1b0e4b33-414f-41eb-b661-41eaaeea0924.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Benzododecinium chloride,139-07-1," Based on the effects observed in the 90-day read across study, the NOEL for the test substance, C12 ADBAC, can be considered to be at 500 ppm in the diet (i.e., equivalent to 31 mg/kg bw/day (or 25 mg a.i./kg bw/d) for males and 38 mg/kg bw/d (i.e. 30 mg a.i./kg bw/d) for females). However, in the absence of ‘true’ systemic effects and in line with the biocides assessment reports, the derivation of a systemic DNEL has been considered to be non-relevant and only a qualitative local risk assessment has been conducted for the test substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01fa4790-2920-4461-8a6f-2d15c8c94038/documents/ccbcbeda-83f4-438e-b73e-34df58b6ac74_9e5ade28-a0a5-4fb5-94a9-2cc47e88acca.html,,,,,, Benzododecinium chloride,139-07-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01fa4790-2920-4461-8a6f-2d15c8c94038/documents/ccbcbeda-83f4-438e-b73e-34df58b6ac74_9e5ade28-a0a5-4fb5-94a9-2cc47e88acca.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Benzododecinium chloride,139-07-1," Based on the results of the read across studies, the oral and dermal LD50 values of the test substance, C12 ADBAC, can be considered to be 344 mg/kg bw and 2730 mg/kg bw respectively. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01fa4790-2920-4461-8a6f-2d15c8c94038/documents/366ff8cd-ec76-441a-b5b2-7500bdc9bbae_9e5ade28-a0a5-4fb5-94a9-2cc47e88acca.html,,,,,, Benzododecinium chloride,139-07-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01fa4790-2920-4461-8a6f-2d15c8c94038/documents/366ff8cd-ec76-441a-b5b2-7500bdc9bbae_9e5ade28-a0a5-4fb5-94a9-2cc47e88acca.html,,oral,LD50,344 mg/kg bw,adverse effect observed, Benzododecinium chloride,139-07-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01fa4790-2920-4461-8a6f-2d15c8c94038/documents/366ff8cd-ec76-441a-b5b2-7500bdc9bbae_9e5ade28-a0a5-4fb5-94a9-2cc47e88acca.html,,dermal,LD50,"2,730 mg/kg bw",adverse effect observed, "N,N-bis(2-hydroxyethyl)dodecanamide",120-40-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c9ca400-3283-41e5-8fa3-27e89fb42147/documents/494ff3de-e15f-4bdf-8f55-5606252733b7_14eb5f0e-aa38-43a7-8a2c-280021fd3808.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,700 mg/kg bw/day,,rat "N,N-bis(2-hydroxyethyl)dodecanamide",120-40-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c9ca400-3283-41e5-8fa3-27e89fb42147/documents/494ff3de-e15f-4bdf-8f55-5606252733b7_14eb5f0e-aa38-43a7-8a2c-280021fd3808.html,Chronic toxicity – systemic effects,dermal,NOAEL,50 mg/kg bw/day,,rat "N,N-bis(2-hydroxyethyl)dodecanamide",120-40-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c9ca400-3283-41e5-8fa3-27e89fb42147/documents/50beabcb-a1f7-429d-a66d-83137e1a880c_14eb5f0e-aa38-43a7-8a2c-280021fd3808.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N-bis(2-hydroxyethyl)dodecanamide",120-40-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c9ca400-3283-41e5-8fa3-27e89fb42147/documents/50beabcb-a1f7-429d-a66d-83137e1a880c_14eb5f0e-aa38-43a7-8a2c-280021fd3808.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, N-(2-hydroxyethyl)dodecanamide,142-78-9, OECD 422 (2018): No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be >= 1000 mg/kg bw/day for males and the No Observed Effect Level (NOEL) for systemic toxicity was considered to be >= 1000 mg/kg bw/day for females. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d9a5d165-5ae5-48a1-a905-67ed8beecbe2/documents/5e0cba3d-fe76-49f9-9767-bc2f7e973f3a_62e9aaf0-7e38-4169-b847-04c0021d665f.html,,,,,, N-(2-hydroxyethyl)dodecanamide,142-78-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d9a5d165-5ae5-48a1-a905-67ed8beecbe2/documents/5e0cba3d-fe76-49f9-9767-bc2f7e973f3a_62e9aaf0-7e38-4169-b847-04c0021d665f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat N-(2-hydroxyethyl)dodecanamide,142-78-9, OECD 420 (2018) - Oral LD50 Females rats = > 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9a5d165-5ae5-48a1-a905-67ed8beecbe2/documents/016a756a-6271-4684-a370-9b84c35581ef_62e9aaf0-7e38-4169-b847-04c0021d665f.html,,,,,, (carboxymethyl)dimethyl-3-[(1-oxododecyl)amino]propylammonium hydroxide,4292-10-8,"Reliable data on repeated dose toxicity of AAPBs are available for the oral route from 28-day and 90-day gavage studies as well as from a 90-day feeding study in rats. In these studies performed according to the corresponding OECD Guidelines on C8-18 AAPB and Coco AAPB, up to and including the highest tested doses, no indication of any systemic toxicity of AAPBs relevant in view of a potential serious health risk for humans was found. NOELs derived from the 90-day gavage and the 90-day feeding study relevant in view of a potential serious health risk for humans were the highest tested doses of 300 mg a. i./kg bw/day (corresponding to 1000 mg product (a. i. ca. 30 %)/kg bw/day) and 1 % in feed (corresponding to 731 mg product/kg bw/day and 247 mg a. i./kg bw/day based on measured food consumption), respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec3ca029-50ac-4e12-ad44-ff51ffc6eab6/documents/136c1a39-ae30-4ea4-be72-a7ebad1cab0e_1ddd7925-03c8-4d3a-b712-1c47f1ce40d0.html,,,,,, (carboxymethyl)dimethyl-3-[(1-oxododecyl)amino]propylammonium hydroxide,4292-10-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec3ca029-50ac-4e12-ad44-ff51ffc6eab6/documents/136c1a39-ae30-4ea4-be72-a7ebad1cab0e_1ddd7925-03c8-4d3a-b712-1c47f1ce40d0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat (carboxymethyl)dimethyl-3-[(1-oxododecyl)amino]propylammonium hydroxide,4292-10-8,"There is no evidence on relevant intrinsic acute toxic activity of AAPB constituting a hazard to human health. Acute toxicity data on AAPBs are available for the oral and for the dermal route. Acute animal studies by inhalation route are unjustified. Due to its very low vapour pressure, an exposure to AAPB vapour is negligible. Generation of aerosols may be theoretically possible, however the estimated exposure is very low. Furthermore, systemic toxicity relevant to humans did not appear neither in acute nor in repeated dose toxicity studies by other exposure routes. Considering the exposure probability and the available information on the intrinsic toxic activity of the substance, an inhalative risk to humans is unlikely and therefore, the conduct of an inhalative toxicity study is unjustified. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec3ca029-50ac-4e12-ad44-ff51ffc6eab6/documents/ca93a2b4-ac61-47c1-a49b-3fd5ee3e79d0_1ddd7925-03c8-4d3a-b712-1c47f1ce40d0.html,,,,,, (carboxymethyl)dimethyl-3-[(1-oxododecyl)amino]propylammonium hydroxide,4292-10-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec3ca029-50ac-4e12-ad44-ff51ffc6eab6/documents/ca93a2b4-ac61-47c1-a49b-3fd5ee3e79d0_1ddd7925-03c8-4d3a-b712-1c47f1ce40d0.html,,oral,LD50,"2,335 mg/kg bw",no adverse effect observed, (carboxymethyl)dimethyl-3-[(1-oxododecyl)amino]propylammonium hydroxide,4292-10-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec3ca029-50ac-4e12-ad44-ff51ffc6eab6/documents/ca93a2b4-ac61-47c1-a49b-3fd5ee3e79d0_1ddd7925-03c8-4d3a-b712-1c47f1ce40d0.html,,dermal,LD50,620 mg/kg bw,no adverse effect observed, Dodecylamine,124-22-1,"No data are available for the primary alkylamine dodecylamines with regard to repeated dose toxicity. However, the 28-day oral toxicity test with the structural analogous primary alkylamines (Z)-octadec-9-enylamines (Genamin OL 100 D) can be used based on read-across principles. This approach is in line with the existing EU risk assessment on primary alkylamines. Groups of five male and female rats recieved the test item by oral gavage at dose levels of 0, 3.25, 12.5 or 50 mg/kg body weight per day for a period of 28 days. At a dose of 50 mg/kg body weight per day clinical signs such as gait abnormalities, reduction in body weight gain and clinical pthology findings indicating mild toxic effects on the liver and kidneys were found. Effects observed at the mid-dose level (12.5 mg/kg) were slight reduction in growth. At the low dose group of 3.25 mg/kg body weight per day no effects were observed. Hence, the NOAEL of this study was placed at 3.25 mg/kg body weight per day. In accordance with the existing EU risk assessment on primary alkylamines, this value is considered to be valid also for dodecylamines and will be used for all relevant exposures by route-to-route extrapolation for this category of chemicals. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b57d60c-dff9-4351-82a1-4f24425676f7/documents/IUC5-1cb3d653-6be5-4d9e-89dc-852a0da3f578_5067818a-6ee1-4449-ac2f-7f2999776207.html,,,,,, Dodecylamine,124-22-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b57d60c-dff9-4351-82a1-4f24425676f7/documents/IUC5-1cb3d653-6be5-4d9e-89dc-852a0da3f578_5067818a-6ee1-4449-ac2f-7f2999776207.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,3.25 mg/kg bw/day,,rat Dodecylamine,124-22-1,"The test material Genamin 12 R 100D (dodecylamines) was tested for acute oral toxicity in a GLP compliant study according to OECD test guideline 401. The test item was applied via gavage to Wistar rats at the limit dose of 2000 mg/kg body weight in sesam oil as vehicle. Clinical signs included squatting posture, stilted gait, irregular breathing, and reduced spontaneous activity. Symptoms started between 10-60 minutes after onset of treatment and were present until day 6 (female animals) or day 9 (male animals). Gross pathology revealed no findings except in one male animal. This animal showed partly connation of stomach epithelia with lobes of liver, spleen, pancreas and abdominal wall which was most probably caused by the corrosive properties of the test material. With regard to acute dermal toxicity, a LD50 value of greater 2000 mg/kg body weight from a guideline conform study on the analogous compound C12-18-(even numbered)-alkylamines can be assumed based on read-across. Data from an inhalation study also with C12-18-(even numbered)-alkylamines indicate a 1hour LC50 greater 0.099 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b57d60c-dff9-4351-82a1-4f24425676f7/documents/IUC5-82831d30-5f8f-430e-bc61-b2c33d45b682_5067818a-6ee1-4449-ac2f-7f2999776207.html,,,,,, Dodecylamine,124-22-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b57d60c-dff9-4351-82a1-4f24425676f7/documents/IUC5-82831d30-5f8f-430e-bc61-b2c33d45b682_5067818a-6ee1-4449-ac2f-7f2999776207.html,,oral,LD50,"2,000 mg/kg bw",, Dodecylamine,124-22-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b57d60c-dff9-4351-82a1-4f24425676f7/documents/IUC5-82831d30-5f8f-430e-bc61-b2c33d45b682_5067818a-6ee1-4449-ac2f-7f2999776207.html,,dermal,LD50,"2,000 mg/kg bw",, Dodecyldimethylamine oxide,1643-20-5," No studies investigating repeated dose oral toxicity have been performed using C12 AO. Data are read across from another member of the amine oxide category, C12-14 AO, which contains a significant proportion of C12 AO itself (typically 60-80%), the remainder comprising analogues with very similar chain lengths. The key study for the oral route is a 90-day repeated dose oral toxicity study in rats comparable to OECD TG 408 [Hazelton Laboratories (1974)] performed with C12-14 AO. The NOAEL was 0.1% (in the diet) or 1000 mg AO/kg diet. Using a food consumption factor of 0.088 kg food/kg bw/day for rats of this strain and age, this translates into a delivered dose of 88 mg AO/kg bw/day. This value represents the highest NOAEL below the lowest LOAEL and was selected for use in the risk assessment to characterize the risk of long term systemic toxicity via the oral and (by route to route extrapolation) dermal and inhalation routes. With regard to dermal toxicity, repeated dermal treatment of mice (6 hours/day/5 days/week) for 90 days with C12-14 AO at dosage levels of 0.27 % AO and 1.33 % AO revealed local signs of irritation but no effects attributable to direct systemic toxicity. A NOAEL regarding systemic effects was therefore not established. Under the conditions of the study the LOEL for local dermal toxicity (irritation) in mice was determined to be 0.27 % AO. Based on an applied dose of 0.27 mg and a patch area of 6 cm2, this is equivalent to 0.045 mg/cm2. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/670b52cb-83b9-45b6-8700-4623dc54d32c/documents/IUC5-6788712d-44d5-44c3-af25-15d32a592cef_2c5b1d24-c9f7-46b5-86e6-3b608e230dc5.html,,,,,, Dodecyldimethylamine oxide,1643-20-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/670b52cb-83b9-45b6-8700-4623dc54d32c/documents/IUC5-6788712d-44d5-44c3-af25-15d32a592cef_2c5b1d24-c9f7-46b5-86e6-3b608e230dc5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,88 mg/kg bw/day,,rat Dodecyldimethylamine oxide,1643-20-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/670b52cb-83b9-45b6-8700-4623dc54d32c/documents/IUC5-6788712d-44d5-44c3-af25-15d32a592cef_2c5b1d24-c9f7-46b5-86e6-3b608e230dc5.html,Repeated dose toxicity – local effects,dermal,LOAEL,0.045 mg/cm2,adverse effect observed,mouse Dodecyldimethylamine oxide,1643-20-5," Acute oral toxicity: No studies are available on C12 AO. However, studies are available for C12-14 AO, where C12 AO makes up 60-80 % of the substance. Read across to the key study [Fulfs JC (1978)] gives an LD50 value of 1064 mg/kg bw. Acute dermal toxicity: No studies are available for C12 AO. Studies are available for C10 AO [Haferkorn j (2012b)], C12-14 AO [Dean WP (1978)] and C12-18 AO [Haferkorn J (2010)] and these are used in a weight of evidence approach since the range of chain lengths covers the C12 AO. On this basis, the LD50 is > 2000 mg/kg bw. Acute inhalation toxicity: No studies are available. The substance is a solid with very low vapour pressure. It is manufactured and supplied as an aqueous solution therefore there is no possibility of exposure to dust. It is used in some spraying applications, but it is expected that inhalation exposure from these applications will be low and hence the dermal route is more relevant. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/670b52cb-83b9-45b6-8700-4623dc54d32c/documents/e7b62a4c-c9ce-4990-8713-a85346568339_2c5b1d24-c9f7-46b5-86e6-3b608e230dc5.html,,,,,, Dodecyldimethylamine oxide,1643-20-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/670b52cb-83b9-45b6-8700-4623dc54d32c/documents/e7b62a4c-c9ce-4990-8713-a85346568339_2c5b1d24-c9f7-46b5-86e6-3b608e230dc5.html,,oral,LD50,"1,064 mg/kg bw",adverse effect observed, Dodecyldimethylamine oxide,1643-20-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/670b52cb-83b9-45b6-8700-4623dc54d32c/documents/e7b62a4c-c9ce-4990-8713-a85346568339_2c5b1d24-c9f7-46b5-86e6-3b608e230dc5.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Dodecan-1-ol, ethoxylated",9002-92-0,"Repeated dose toxicity: Oral In an OECD 422 study performed in Wistar rats, NOAEL in male rats was found at 100 mg/kg bw/day based on dose-dependent decreases in locomotor activity at 300 and 700 mg/kg bw/day whereas NOAEL in female rats was found at 300 mg/kg bw/day based on dullness in all animals treated at 700 md/kg bw/day. All of these effects, including dullness observed in all males treated at 700 mg/kg bw/day, showed complete reversibility during the recovery period.   Repeated dose toxicity: Inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance Dodecan-1-ol, ethoxylated (CAS No; 9002-92-0 EC No; 500-002-6) which is reported as 7.5X10-11mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical Dodecan-1-ol, ethoxylated (CAS No; 9002-92-0 EC No; 500-002-6) is highly unlikely. Therefore this study is considered for waiver.   Repeated dermal study; The acute toxicity value for Dodecan-1-ol, ethoxylated (CAS No; 9002-92-0 EC No; 500-002-6) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that Dodecan-1-ol, ethoxylated shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Dodecan-1-ol, ethoxylated shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): K1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14bdf7e2-55e0-4086-8d0b-81c2d77589cd/documents/900d5d23-9042-4407-b995-2a50cae33ffd_63f48e44-1671-4f59-8792-1f4c97a68b57.html,,,,,, "Dodecan-1-ol, ethoxylated",9002-92-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14bdf7e2-55e0-4086-8d0b-81c2d77589cd/documents/900d5d23-9042-4407-b995-2a50cae33ffd_63f48e44-1671-4f59-8792-1f4c97a68b57.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Dodecan-1-ol, ethoxylated",9002-92-0," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different experimental studies conducted on rats and mice for the test chemical. The LD50 value is 1000 mg/kg bw. The study concluded that the LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified into the “Category 4” for acute oral toxicity. Acute Inhalation Toxicity: The acute toxicity inhalation study need not be conducted because exposure to humans via inhalation route is not likely taking into account the low vapour pressure of the substance, which is reported as 1.77E-5 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely. Therefore this study is considered for waiver. Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on experimental studies conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14bdf7e2-55e0-4086-8d0b-81c2d77589cd/documents/b9c07283-2f2e-4e83-895d-28f7117cc058_63f48e44-1671-4f59-8792-1f4c97a68b57.html,,,,,, "Dodecan-1-ol, ethoxylated",9002-92-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14bdf7e2-55e0-4086-8d0b-81c2d77589cd/documents/b9c07283-2f2e-4e83-895d-28f7117cc058_63f48e44-1671-4f59-8792-1f4c97a68b57.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, "Dodecan-1-ol, ethoxylated",9002-92-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14bdf7e2-55e0-4086-8d0b-81c2d77589cd/documents/b9c07283-2f2e-4e83-895d-28f7117cc058_63f48e44-1671-4f59-8792-1f4c97a68b57.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Lauric acid,143-07-7,"Reliable studies on oral repeated dose toxicity are available for the following category members:Subchronic: NOAEL oral = ca. 5000 mg/kg bw/d; CAS# 143-07-7, C12 (Fitzhugh 1960)Subchronic: NOAEL oral = 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao 2002)No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c0ef8c9-7785-440b-adb3-2c0e4de85270/documents/IUC5-6df1fc00-2a3f-4536-aefe-d530f503fb9f_c6eb4cfb-4c50-4d53-b585-681ce99736a2.html,,,,,, Lauric acid,143-07-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c0ef8c9-7785-440b-adb3-2c0e4de85270/documents/IUC5-6df1fc00-2a3f-4536-aefe-d530f503fb9f_c6eb4cfb-4c50-4d53-b585-681ce99736a2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Lauric acid,143-07-7,Acute Toxicity:- oral: LD50 (rat) >5000 mg/kg bw (OECD 401)- inhalative: LC50 >0.1521 mg/L (IHT; Analogy CAS 124-07-2)- dermal: LD50 >2000 mg/kg bw (Analogy CAS 57-11-4) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c0ef8c9-7785-440b-adb3-2c0e4de85270/documents/IUC5-9dde1319-fca2-42cd-881d-598a815b9b1e_c6eb4cfb-4c50-4d53-b585-681ce99736a2.html,,,,,, N6-(1-oxododecyl)-L-lysine,52315-75-0," The aim of this repeated dose toxicity study was to obtain information on the toxicity of Famex LL T administered once daily by oral administration via gavage to rats for 28 consecutive days. The animals were treated with 100, 300 or 1000 mg Famex LL T/kg b.w./day. The control animals received the vehicle (0.5% Methylcellulose 400). None of the animals died or had to be sacrificed prematurely. No test itemrelated changes were observed for the behaviour or external appearance of the animals, the detailed clinical observations, the neurological screening, the body weight, body weight gain and body weight at autopsy, the food and drinking water consumption, for any of the haematological and clinical chemical parameters, the eyes or optic region, the auditory acuity, the relative and absolute organ weights, and at macroscopic inspection at necropsy at any dose level. The histopathological examination did not reveal any test item-related morphological changes. The experimental no-observed-effect level (NOEL) was above 1000 mg Famex LL T/kg b.w./day, by daily oral administration. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/750375a7-72ae-414a-ac20-0b66c334b8e9/documents/4f3c802b-d9d0-4ad4-9985-d3fd3fb44250_f0a90445-b16b-4362-9473-a58eff437652.html,,,,,, N6-(1-oxododecyl)-L-lysine,52315-75-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/750375a7-72ae-414a-ac20-0b66c334b8e9/documents/4f3c802b-d9d0-4ad4-9985-d3fd3fb44250_f0a90445-b16b-4362-9473-a58eff437652.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat N6-(1-oxododecyl)-L-lysine,52315-75-0, The test item was administered once orally to male ICR mice at dose levels of 1000 or 3000 mg/kg bw. This dosing caused no adverse effects and therefore the oral LD50 was > 3000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/750375a7-72ae-414a-ac20-0b66c334b8e9/documents/ab20017d-29aa-45aa-ac53-2344f8bb507f_f0a90445-b16b-4362-9473-a58eff437652.html,,,,,, N6-(1-oxododecyl)-L-lysine,52315-75-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/750375a7-72ae-414a-ac20-0b66c334b8e9/documents/ab20017d-29aa-45aa-ac53-2344f8bb507f_f0a90445-b16b-4362-9473-a58eff437652.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, N-lauroylsarcosine,97-78-9,"NOAEL (chronic, rat) ≥ 1000 mg/kg bw/day, based on read-across ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e09c1cf4-bc55-4b50-a545-18f2f8220c4c/documents/IUC5-570879ec-25d4-4d07-932a-1cbe2aa8fa75_c24b09bf-7af9-461f-a3f0-ef11ba51d669.html,,,,,, N-lauroylsarcosine,97-78-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e09c1cf4-bc55-4b50-a545-18f2f8220c4c/documents/IUC5-570879ec-25d4-4d07-932a-1cbe2aa8fa75_c24b09bf-7af9-461f-a3f0-ef11ba51d669.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat N-lauroylsarcosine,97-78-9,"Oral (OECD 401), rat (m/f): LD50 > 5000 mg/kg bw (limit test), based on read-acrossInhalation (OECD 403), rat (m/f): 1 mg/L < LC50 < 5 mg/L, based on read-acrossDermal (OECD 402), rat (m/f): LD50 > 2000 mg/kg bw (limit test), based on read-across ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e09c1cf4-bc55-4b50-a545-18f2f8220c4c/documents/IUC5-b41270cd-f3a3-495e-8bd1-ade39dcfb776_c24b09bf-7af9-461f-a3f0-ef11ba51d669.html,,,,,, N-lauroylsarcosine,97-78-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e09c1cf4-bc55-4b50-a545-18f2f8220c4c/documents/IUC5-b41270cd-f3a3-495e-8bd1-ade39dcfb776_c24b09bf-7af9-461f-a3f0-ef11ba51d669.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, N-lauroylsarcosine,97-78-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e09c1cf4-bc55-4b50-a545-18f2f8220c4c/documents/IUC5-b41270cd-f3a3-495e-8bd1-ade39dcfb776_c24b09bf-7af9-461f-a3f0-ef11ba51d669.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, N-lauroylsarcosine,97-78-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e09c1cf4-bc55-4b50-a545-18f2f8220c4c/documents/IUC5-b41270cd-f3a3-495e-8bd1-ade39dcfb776_c24b09bf-7af9-461f-a3f0-ef11ba51d669.html,,inhalation,LC50,"1,000 mg/m3",adverse effect observed, Dodecyltrimethylammonium bromide,1119-94-4," Under the conditions of the present study, the LD50 value for dodecyltrimethylammonium bromide is expected to be between 50 - 300 mg/kg bw after single oral administration in rats (reference 7.2.1-1). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d3cff5d-45e9-4f0d-8fdd-2face4396920/documents/d2e26aa2-4eb9-4a50-a172-470431dcbf7a_a90e9c6a-21bd-42c3-a3de-76bf292b3ce4.html,,,,,, Dodecyltrimethylammonium bromide,1119-94-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d3cff5d-45e9-4f0d-8fdd-2face4396920/documents/d2e26aa2-4eb9-4a50-a172-470431dcbf7a_a90e9c6a-21bd-42c3-a3de-76bf292b3ce4.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, "Laurus nobilis, ext.",84603-73-6,"Acute toxicity, oral: LD50 = 3950 mg/kg bw (K, Rel.2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90719c8d-84c3-4473-81fe-54eb19804493/documents/IUC5-04e79aae-6254-4707-9df9-e173e9a63908_a63b4928-df51-4ae0-9c9b-4d743ca74224.html,,,,,, "Laurus nobilis, ext.",84603-73-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90719c8d-84c3-4473-81fe-54eb19804493/documents/IUC5-04e79aae-6254-4707-9df9-e173e9a63908_a63b4928-df51-4ae0-9c9b-4d743ca74224.html,,oral,LD50,"3,950 mg/kg bw",no adverse effect observed, Dodecan-1-ol,112-53-8," There are no reliable long-term repeated dose toxicity data available on dodecan-1-ol (CAS 112-53-8). In the key study, no adverse effects were seen after dietary administration of Alcohols, C14-15-branched and linear for 90 days to rats (Ito et al., 1978) which reported a NOAEL value of >3548 mg/kg bw/day. This value is supported by data from a 13-week from a reliable oral feeding study in rats using hexadecan-1-ol. This study reports a NOAEL value of > 4400 mg/kg bw/day. (Scientific Associates 1966a). In addition a read across 28-day study using octadecan-1-ol (rat, oral gavage), reported a NOAEL >1000 mg/kg bw/day (Henkel, 1985a; rel. 2). A read-across from a reliable 13-week dietary study in rats using hexan-1-ol reported a NOAEL of 1127 mg/kg bw/day (Scientific Associates Inc., 1966). No adverse effects were noted at any of the dose levels administered during the study. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4d0a5c4-dbd7-47c6-a3de-6f0ffb4cf474/documents/36552117-34bf-4fc2-b673-52d263334370_fef8f79d-fc14-49a3-83db-a7636e12887d.html,,,,,, Dodecan-1-ol,112-53-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4d0a5c4-dbd7-47c6-a3de-6f0ffb4cf474/documents/36552117-34bf-4fc2-b673-52d263334370_fef8f79d-fc14-49a3-83db-a7636e12887d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,548 mg/kg bw/day",,rat Dodecan-1-ol,112-53-8," The key acute oral toxicity study for dodecan-1-ol, conducted according to the now-deleted OECD Test Guideline 401 and in compliance with GLP, reports an LD50 value of >2000 mg/kg bw in rat (Safepharm Laboratory, 1996; rel 1). There are no acute inhalation toxicity data for dodecan-1-ol. Therefore data are read-across from decan-1-ol and tetradecan-1-ol. The acute inhalation toxicity study with decan-1-ol, conducted prior to OECD Test Guideline and GLP, reports an LC50 of >71mg/L in rats, following 1-hour whole body inhalation exposure to the atmosphere generated as a mist (Scientific Associates 1977; rel 2). The acute inhalation toxicity study with tetradecan-1-ol, conducted prior to OECD Test Guideline and GLP, reports an LC50 of >1.5 mg/L air in rat, following 1-hour whole body inhalation exposure to vapour (Scientific Associates, 1977; rel 2). The key acute dermal toxicity for dodecan-1-ol conducted according to a protocol similar to OECD Test Guideline 402 but not in compliance with GLP, reports and LD50 in the range of between 8000 and 12000 mg/kg bw/day in rabbits (Scientific Associates 1977f; rel 2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4d0a5c4-dbd7-47c6-a3de-6f0ffb4cf474/documents/0359dba2-a284-444b-954f-41e05588d623_fef8f79d-fc14-49a3-83db-a7636e12887d.html,,,,,, Dodecan-1-ol,112-53-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4d0a5c4-dbd7-47c6-a3de-6f0ffb4cf474/documents/0359dba2-a284-444b-954f-41e05588d623_fef8f79d-fc14-49a3-83db-a7636e12887d.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Dodecan-1-ol,112-53-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4d0a5c4-dbd7-47c6-a3de-6f0ffb4cf474/documents/0359dba2-a284-444b-954f-41e05588d623_fef8f79d-fc14-49a3-83db-a7636e12887d.html,,dermal,LD50,">=8,000 mg/kg bw",no adverse effect observed, Dodecan-1-ol,112-53-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4d0a5c4-dbd7-47c6-a3de-6f0ffb4cf474/documents/0359dba2-a284-444b-954f-41e05588d623_fef8f79d-fc14-49a3-83db-a7636e12887d.html,,inhalation,LC50,"1,500 mg/m3",no adverse effect observed, (carboxylatomethyl)dodecyldimethylammonium,683-10-3," Other than slight clinical chemistry changes observed in high dose animals; no gross or histologic alterations, including to reproductive organs, attributed to test material (cetyl betaine) were observed. In addition, reviews by US EPA on the class of substance (surrogate betaines) demonstrate that toxicity for this class is limited to GI tract irritation with no evidence of specific organ toxicity. In view of the primary use in cosmetics, further animal testing can not be justifed. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ff7ed09-71e4-4269-b780-7e9de0463375/documents/3d41043d-6d8f-4dee-9fd3-5df588739015_f544126c-cc7b-4029-9934-5742c53e3c08.html,,,,,, (carboxylatomethyl)dodecyldimethylammonium,683-10-3," From the surrogate data available, this substance does not appear to exhibit acute toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ff7ed09-71e4-4269-b780-7e9de0463375/documents/63d532de-d7ab-4f8e-8c99-c97e025b4aa2_f544126c-cc7b-4029-9934-5742c53e3c08.html,,,,,, Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium,13197-76-7, A 90 -day oral toxicity study is available. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8f13743-555c-43be-b9e3-c9db9aa14348/documents/d37fd6b1-6706-4793-80fd-88d9b30ae404_1f640823-0413-407c-a624-39769709e47d.html,,,,,, Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium,13197-76-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8f13743-555c-43be-b9e3-c9db9aa14348/documents/d37fd6b1-6706-4793-80fd-88d9b30ae404_1f640823-0413-407c-a624-39769709e47d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,380 mg/kg bw/day,,rat Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium,13197-76-7, An acute oral toxicity study is available. A waiver is proposed for acute inhalation toxicity based on the physiochemical properties of the substance. A waiver is proposed for acute dermal toxicity based on the low acute toxicity of the substance. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8f13743-555c-43be-b9e3-c9db9aa14348/documents/f21a72dd-0b20-4097-9a13-b2772aa7b836_1f640823-0413-407c-a624-39769709e47d.html,,,,,, Dodecyl(2-hydroxy-3-sulphonatopropyl)dimethylammonium,13197-76-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8f13743-555c-43be-b9e3-c9db9aa14348/documents/f21a72dd-0b20-4097-9a13-b2772aa7b836_1f640823-0413-407c-a624-39769709e47d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dodecyl lactate,6283-92-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Low (not assignable). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Based on tests with shorter chain alkyl lactates. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Based on tests with shorter chain alkyl lactates. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): Low (not assignable). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c72d7294-b942-4790-9bfc-127f242ce27a/documents/58912bd4-7e3d-4222-94e8-bf792f700711_0469896c-04a0-4bc3-bc97-9c974e3ff43f.html,,,,,, Dodecyl lactate,6283-92-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c72d7294-b942-4790-9bfc-127f242ce27a/documents/58912bd4-7e3d-4222-94e8-bf792f700711_0469896c-04a0-4bc3-bc97-9c974e3ff43f.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rat Dodecyl lactate,6283-92-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c72d7294-b942-4790-9bfc-127f242ce27a/documents/58912bd4-7e3d-4222-94e8-bf792f700711_0469896c-04a0-4bc3-bc97-9c974e3ff43f.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,600 mg/m3,,rat Dodecyl lactate,6283-92-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c72d7294-b942-4790-9bfc-127f242ce27a/documents/58912bd4-7e3d-4222-94e8-bf792f700711_0469896c-04a0-4bc3-bc97-9c974e3ff43f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,75 mg/m3,adverse effect observed,rat Dodecyl lactate,6283-92-7," Justification for selection of acute toxicity – oral endpoint: Key studies performed with products containing C12 -C16 (even) lactates and C12 -C15 lactates. Ceraphyl®31 containing C12 -C16 (even) lactates and Ceraphyl®41 containing C12 -C15 lactates all have an oral LD50 of 20,000 mg/kg - inhalation endpoint: The inhalation LC50 of lactate esters is generally above 5000 mg/m3. – dermal endpoint: Testing with analogue alkyl lactates confirm the low acute dermal toxicity of the product for registration. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c72d7294-b942-4790-9bfc-127f242ce27a/documents/ccae8b93-91cd-4272-8daf-249bcd03c155_0469896c-04a0-4bc3-bc97-9c974e3ff43f.html,,,,,, Dodecyl lactate,6283-92-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c72d7294-b942-4790-9bfc-127f242ce27a/documents/ccae8b93-91cd-4272-8daf-249bcd03c155_0469896c-04a0-4bc3-bc97-9c974e3ff43f.html,,oral,LD50,"20,000 mg/kg bw",no adverse effect observed, Dodecyl lactate,6283-92-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c72d7294-b942-4790-9bfc-127f242ce27a/documents/ccae8b93-91cd-4272-8daf-249bcd03c155_0469896c-04a0-4bc3-bc97-9c974e3ff43f.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Dodecyl lactate,6283-92-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c72d7294-b942-4790-9bfc-127f242ce27a/documents/ccae8b93-91cd-4272-8daf-249bcd03c155_0469896c-04a0-4bc3-bc97-9c974e3ff43f.html,,inhalation,discriminating conc.,"5,000 mg/m3",, Dodecyl laurate,13945-76-1," Oral (equivalent to OECD 407, read across): NOAEL rat = 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2d1f508-880f-4d92-bdc0-6c51d302f30c/documents/a559bf44-4ba5-443f-a592-1cc8062b070b_423a4533-21a4-4ddc-9c2f-c8f142b2705f.html,,,,,, Dodecyl laurate,13945-76-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2d1f508-880f-4d92-bdc0-6c51d302f30c/documents/a559bf44-4ba5-443f-a592-1cc8062b070b_423a4533-21a4-4ddc-9c2f-c8f142b2705f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dodecyl laurate,13945-76-1," Oral (similar to OECD 401, read across): LD50 rat > 5000 mg/kg bw Dermal (OECD 402, read across): LD50 rat > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2d1f508-880f-4d92-bdc0-6c51d302f30c/documents/02de2129-e17d-4cc5-b6ee-18a88a5165cb_423a4533-21a4-4ddc-9c2f-c8f142b2705f.html,,,,,, Dodecyl methacrylate,142-90-5," Subacute study; oral (gavage); rat (Sprague Dawley SD), m/f (OECD guideline 422, Klimisch score: 1, GLP), no toxicity occurred up to the highest administered dose of 1000 mg/kg/day with dodecyl methacrylate: NOAEL = 1000 mg/kg bw/d (CIT, 2007). With regard to the low repeated dose oral toxicity and the characteristics of skin penetration and metabolism in the skin, the repeated dose dermal toxicity can be considered as low. The inhalation route is not of relevance due to the very low vapour pressure of the substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9c63451-ce8e-4a5a-8825-eab05e8b620f/documents/a2d1f995-22d9-4820-afa0-62488c142920_4cd92f38-b877-408b-866d-f9eda1220f5c.html,,,,,, Dodecyl methacrylate,142-90-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9c63451-ce8e-4a5a-8825-eab05e8b620f/documents/a2d1f995-22d9-4820-afa0-62488c142920_4cd92f38-b877-408b-866d-f9eda1220f5c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dodecyl methacrylate,142-90-5," The acute toxicity of dodecyl methacrylate ester can be considered as very low by the oral (LD50: > 5000 mg/kg, oral, rat, OECD 401, GLP, Klimisch score: 1) and dermal route (LD50: > 3000 mg/kg, Structurally related substance Isodecyl methacrylate, dermal, rabbit, Klimisch score: 2). Peer reviewed handbook data of Dodecyl methacrylate LD50: > 3000 mg/kg, dermal, rabbit (Nemec JW, Kirch LS, 1978) supports this result. The inhalation route is not of relevance due to the very low vapour pressure (0.0064 hPa at 25 °C) of the substance. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9c63451-ce8e-4a5a-8825-eab05e8b620f/documents/6797d3cd-5cb4-4260-9248-8b12b0233009_4cd92f38-b877-408b-866d-f9eda1220f5c.html,,,,,, Dodecyl methacrylate,142-90-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9c63451-ce8e-4a5a-8825-eab05e8b620f/documents/6797d3cd-5cb4-4260-9248-8b12b0233009_4cd92f38-b877-408b-866d-f9eda1220f5c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Dodecyl methacrylate,142-90-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9c63451-ce8e-4a5a-8825-eab05e8b620f/documents/6797d3cd-5cb4-4260-9248-8b12b0233009_4cd92f38-b877-408b-866d-f9eda1220f5c.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, Dodecyl oleate,36078-10-1,"NOAEL systemic= 300 mg/kg bw/day   The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the LCAE category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the LCAE category. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29342acc-f7c2-4ef3-a02d-2764a1575356/documents/c378164b-df41-49b4-a912-331d076a3520_96767226-7ddf-4cd1-b4fe-869934266020.html,,,,,, Dodecyl oleate,36078-10-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29342acc-f7c2-4ef3-a02d-2764a1575356/documents/c378164b-df41-49b4-a912-331d076a3520_96767226-7ddf-4cd1-b4fe-869934266020.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Dodecyl oleate,36078-10-1,"All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air.   The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the LCAE category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the LCAE category. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29342acc-f7c2-4ef3-a02d-2764a1575356/documents/97e90504-bc3f-448f-b21e-ecf2bf56e315_96767226-7ddf-4cd1-b4fe-869934266020.html,,,,,, N-(n-dodecyl)pyrrolidinone,2687-96-9,"Repeated dose oral:A 28-day oral toxicity study (Smith, 1989) was available which is key study. This study showed that No Observed Adverse Effect Level (NOAEL) for the test substance is 100 mg/kg/day. A 90-day oral (capsule) toxicity study with dog (Liao, 1991) which run on analog substance N-(n-octyl)-2-pyrrolidinone (2687-94-7) is available which is key study. The NOAEL was 30 mg/kg bw/day.Repeated dose inhalation:Endpoint waived as the substance is corrosive to the skin.Repeated dose dermal:A repeated dose dermal study (Busch, 1987) used 2% w/v suspension in distilled water was available which is supporting study. This study showed that a mean comedogenic grade of ≥ 2.0 in rabbits. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/749d9d42-e38c-44d2-86d6-ad37a664d720/documents/IUC5-94b3f463-32d7-4618-b8fb-a5464340b551_07d32e5d-06f9-4c7f-8ebf-d50b9c59dd23.html,,,,,, N-(n-dodecyl)pyrrolidinone,2687-96-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/749d9d42-e38c-44d2-86d6-ad37a664d720/documents/IUC5-94b3f463-32d7-4618-b8fb-a5464340b551_07d32e5d-06f9-4c7f-8ebf-d50b9c59dd23.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,38 mg/kg bw/day,,dog N-(n-dodecyl)pyrrolidinone,2687-96-9,"Acute oral toxicity:An acute oral toxicity study with rat (Nitka, 1986) which run on analog substance N-(n-octyl)-2-pyrrolidinone (2687-94-7) is available which is key study. The LD50 was 2.05 g/kg bodyweight.Acute inhalation toxicity:Study waived due to low vapour pressure (0.00204 Pa).Acute dermal toxicity:An acute dermal toxicity study (Nitka, 1987) is available which is key study. This study showed that the test substance is not toxic dermally to rabbits. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/749d9d42-e38c-44d2-86d6-ad37a664d720/documents/IUC5-f6c59b67-7d69-4083-9f19-ec1c58b3535f_07d32e5d-06f9-4c7f-8ebf-d50b9c59dd23.html,,,,,, N-(n-dodecyl)pyrrolidinone,2687-96-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/749d9d42-e38c-44d2-86d6-ad37a664d720/documents/IUC5-f6c59b67-7d69-4083-9f19-ec1c58b3535f_07d32e5d-06f9-4c7f-8ebf-d50b9c59dd23.html,,dermal,LD50,"2,000 mg/kg bw",, "N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine",2372-82-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2b08601-9e91-4982-abf4-7432bf06395c/documents/IUC5-e91a3433-d6ba-494c-89ba-ae97cac4dcc0_6079a896-f5f2-4593-bb93-848057338c68.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,15 mg/kg bw/day,,rat "N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine",2372-82-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2b08601-9e91-4982-abf4-7432bf06395c/documents/IUC5-e91a3433-d6ba-494c-89ba-ae97cac4dcc0_6079a896-f5f2-4593-bb93-848057338c68.html,Chronic toxicity – systemic effects,oral,NOAEL,4 mg/kg bw/day,,rat "N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine",2372-82-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2b08601-9e91-4982-abf4-7432bf06395c/documents/IUC5-aa7903cd-dbe5-4ea4-aef9-840dae4ab78d_6079a896-f5f2-4593-bb93-848057338c68.html,,oral,LD50,261 mg/kg bw,adverse effect observed, "N-(3-aminopropyl)-N-dodecylpropane-1,3-diamine",2372-82-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2b08601-9e91-4982-abf4-7432bf06395c/documents/IUC5-aa7903cd-dbe5-4ea4-aef9-840dae4ab78d_6079a896-f5f2-4593-bb93-848057338c68.html,,dermal,LD50,600 mg/kg bw,adverse effect observed, 1-dodecylpyridinium chloride,104-74-5," Repeated dose toxcity: Oral The No Observed Adverse Effect Level (NOAEL) for the test chemical was considered to be 40 mg/kg bw/day in CD-1 mice after repeated exposure via oral route.   Repeated inhalation study: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 1-dodecylpyridinium chloride (104-74-5) which is reported as 0.000034502838 mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical 1-dodecylpyridinium chloride is highly unlikely. Therefore this study is considered for waiver. Repeated dermal study; The acute toxicity value for 1-dodecylpyridinium chloride (104-74-5) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 1-dodecylpyridinium chloride shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 1-dodecylpyridinium chloride shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a2f57fb-0337-4857-89ff-e353e45af739/documents/968b902e-37d6-4c16-8e02-8d27753dcfeb_5eec342a-d0b4-469b-b27c-f8955cebd16c.html,,,,,, 1-dodecylpyridinium chloride,104-74-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a2f57fb-0337-4857-89ff-e353e45af739/documents/968b902e-37d6-4c16-8e02-8d27753dcfeb_5eec342a-d0b4-469b-b27c-f8955cebd16c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,mouse 1-dodecylpyridinium chloride,104-74-5," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical.The study concluded that the LD50 value isbetween50-300 mg/kg bw, for acute oral toxicity.Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 3” for acute oral toxicity.  Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0046 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The study concluded that the LD50 value is >1000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4 (>1000-2000 mg/kg bw)” for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a2f57fb-0337-4857-89ff-e353e45af739/documents/0f820bae-eab0-4b2a-a563-46701750fba5_5eec342a-d0b4-469b-b27c-f8955cebd16c.html,,,,,, 1-dodecylpyridinium chloride,104-74-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a2f57fb-0337-4857-89ff-e353e45af739/documents/0f820bae-eab0-4b2a-a563-46701750fba5_5eec342a-d0b4-469b-b27c-f8955cebd16c.html,,oral,LD50,200 mg/kg bw,adverse effect observed, 1-dodecylpyridinium chloride,104-74-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a2f57fb-0337-4857-89ff-e353e45af739/documents/0f820bae-eab0-4b2a-a563-46701750fba5_5eec342a-d0b4-469b-b27c-f8955cebd16c.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, "Lavender, Lavandula angustifolia, ext.",90063-37-9,NOAEL (males and females) = 160 mg/kg bw/day based on a GLP study conducted similarly to OECD test guideline No. 407 on a read-across substance. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b851da2d-9caa-44ba-a1be-1819fdc61f2d/documents/45615666-a2d6-4612-8b90-e14cc82cdf90_a72f5ad6-4414-4803-b92d-01a683d3ca34.html,,,,,, "Lavender, Lavandula angustifolia, ext.",90063-37-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b851da2d-9caa-44ba-a1be-1819fdc61f2d/documents/45615666-a2d6-4612-8b90-e14cc82cdf90_a72f5ad6-4414-4803-b92d-01a683d3ca34.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,160 mg/kg bw/day,,rat "Lavender, Lavandula angustifolia, ext.",90063-37-9,"Acute oral toxicity: LD50 > 5400 mg/kg bw (similar to OECD 401, 1989, GLP, rel.2) Acute dermal toxicity: LD50 > 5000 mg/kg bw (Standard acute method, 1973, pre-GLP) Acute toxicity by inhalation: no information available ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b851da2d-9caa-44ba-a1be-1819fdc61f2d/documents/02fc73c5-d7fd-44a8-a226-d6551d0a15fb_a72f5ad6-4414-4803-b92d-01a683d3ca34.html,,,,,, "Lavender, Lavandula angustifolia, ext.",90063-37-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b851da2d-9caa-44ba-a1be-1819fdc61f2d/documents/02fc73c5-d7fd-44a8-a226-d6551d0a15fb_a72f5ad6-4414-4803-b92d-01a683d3ca34.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Lavender, Lavandula angustifolia, ext.",90063-37-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b851da2d-9caa-44ba-a1be-1819fdc61f2d/documents/02fc73c5-d7fd-44a8-a226-d6551d0a15fb_a72f5ad6-4414-4803-b92d-01a683d3ca34.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Lavender, Lavandula hybrida, ext.",91722-69-9,NOAEL (males and females) = 160 mg/kg bw/day based on a GLP study conducted similarly to OECD test guideline No. 407 on a read-across substance. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7884a330-a240-42c7-b592-e966756b3a6f/documents/78f33436-9e23-41c3-b82b-1602bade93e3_f2c0f2ee-ef66-42d6-a2c0-3599dec75478.html,,,,,, "Lavender, Lavandula hybrida, ext.",91722-69-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7884a330-a240-42c7-b592-e966756b3a6f/documents/78f33436-9e23-41c3-b82b-1602bade93e3_f2c0f2ee-ef66-42d6-a2c0-3599dec75478.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,160 mg/kg bw/day,,rat "Lavender, Lavandula hybrida, ext.",91722-69-9,"Acute oral toxicity: LD50 > 5000 mg/kg bw (Standard acute method, 1973, pre-GLP) Acute dermal toxicity: LD50 > 5000 mg/kg bw (Standard acute method, 1973, pre-GLP) Acute toxicity by inhalation: no information available ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7884a330-a240-42c7-b592-e966756b3a6f/documents/b595d31a-01df-4b60-9034-940f002fb455_f2c0f2ee-ef66-42d6-a2c0-3599dec75478.html,,,,,, "Lavender, Lavandula hybrida, ext.",91722-69-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7884a330-a240-42c7-b592-e966756b3a6f/documents/b595d31a-01df-4b60-9034-940f002fb455_f2c0f2ee-ef66-42d6-a2c0-3599dec75478.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Lavender, Lavandula hybrida, ext.",91722-69-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7884a330-a240-42c7-b592-e966756b3a6f/documents/b595d31a-01df-4b60-9034-940f002fb455_f2c0f2ee-ef66-42d6-a2c0-3599dec75478.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Lavender, Lavandula latifolia, ext.",84837-04-7," In an acute oral toxicity the oral LD50 of Lavandin oil was higher than 5000 mg/kg bw in rats, as a consequence it is considered that LD50 of Spike lavender oil will be higher than 5000 mg/kg bw (Read Across Rel. K2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ca31907-99d8-41e8-86ce-dd2583480963/documents/d59f7a5b-aad3-48cf-a8b3-770a52e21d7a_17b79d50-630b-40da-b062-5b975348c7b0.html,,,,,, "Lavender, Lavandula latifolia, ext.",84837-04-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ca31907-99d8-41e8-86ce-dd2583480963/documents/d59f7a5b-aad3-48cf-a8b3-770a52e21d7a_17b79d50-630b-40da-b062-5b975348c7b0.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Lead di(acetate),301-04-2," Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eea2b157-5c22-439c-8603-992ece44b341/documents/55240df1-e7fa-4fe8-8269-766f9e1416fc_d25f207b-0a1c-4de0-9f71-43aaf3cb69a8.html,,,,,, Lead di(acetate),301-04-2, Inorganic lead compounds do not exhibit toxicity in acute toxicity tests with experimental animals. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eea2b157-5c22-439c-8603-992ece44b341/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_d25f207b-0a1c-4de0-9f71-43aaf3cb69a8.html,,,,,, Lead di(acetate),301-04-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eea2b157-5c22-439c-8603-992ece44b341/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_d25f207b-0a1c-4de0-9f71-43aaf3cb69a8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Lead di(acetate),301-04-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eea2b157-5c22-439c-8603-992ece44b341/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_d25f207b-0a1c-4de0-9f71-43aaf3cb69a8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Lead di(acetate),301-04-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eea2b157-5c22-439c-8603-992ece44b341/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_d25f207b-0a1c-4de0-9f71-43aaf3cb69a8.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, L-leucine,61-90-5,No adverse effects were observed upon oral administration of > 3000 mg/kg bw/d of L-leucine to rats for 90 days.NOAEL: 3330 mg/kg bw/d (males); 3840 mg/kg bw/d (females). ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a0a77e0-83f8-48c8-957b-68cd557a6304/documents/IUC5-ead8d46d-ee4b-466d-98ce-2bb04a58f7f8_09c492d1-5a29-4346-a336-e250598bcb26.html,,,,,, L-leucine,61-90-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a0a77e0-83f8-48c8-957b-68cd557a6304/documents/IUC5-ead8d46d-ee4b-466d-98ce-2bb04a58f7f8_09c492d1-5a29-4346-a336-e250598bcb26.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,330 mg/kg bw/day",,rat L-leucine,61-90-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): All available studies (including the study on read-across substance L-valine) are in line with each other, i.e. no mortalities occurred in any of the experiments. The LD50 is therefore > 16000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a0a77e0-83f8-48c8-957b-68cd557a6304/documents/IUC5-51552aa5-3761-47a4-a54a-0781f910feaf_09c492d1-5a29-4346-a336-e250598bcb26.html,,,,,, L-leucine,61-90-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a0a77e0-83f8-48c8-957b-68cd557a6304/documents/IUC5-51552aa5-3761-47a4-a54a-0781f910feaf_09c492d1-5a29-4346-a336-e250598bcb26.html,,oral,LD50,"16,000 mg/kg bw",no adverse effect observed, 4-oxovaleric acid,123-76-2,"No adverse treatment-related response that results in change in morphology, physiology or growth  of an animal organism was recorded. The NOAEL (No Observed Adverse Effect Level) value for REPEATED DOSE TOXICITY (90 days) in male and female rats for the test item acid was established as 1 000 mg/kg body weight/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e66f6bd6-ced7-41d7-9de1-0b13a25e5ab1/documents/f83c89bc-49e2-418d-a1ac-521a0fb1cd25_7b93552c-af49-47e8-94fa-384ada37c642.html,,,,,, 4-oxovaleric acid,123-76-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e66f6bd6-ced7-41d7-9de1-0b13a25e5ab1/documents/f83c89bc-49e2-418d-a1ac-521a0fb1cd25_7b93552c-af49-47e8-94fa-384ada37c642.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-oxovaleric acid,123-76-2," 300 mg/kg < LD50 (rat, oral) < 2000 mg/kg LD50 (rat, dermal) > 2000 mg/kg ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e66f6bd6-ced7-41d7-9de1-0b13a25e5ab1/documents/b6f6a11c-ed2b-47b1-9bfa-a60d54e23dee_7b93552c-af49-47e8-94fa-384ada37c642.html,,,,,, 4-oxovaleric acid,123-76-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e66f6bd6-ced7-41d7-9de1-0b13a25e5ab1/documents/b6f6a11c-ed2b-47b1-9bfa-a60d54e23dee_7b93552c-af49-47e8-94fa-384ada37c642.html,,oral,LD50,300 mg/kg bw,adverse effect observed, 4-oxovaleric acid,123-76-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e66f6bd6-ced7-41d7-9de1-0b13a25e5ab1/documents/b6f6a11c-ed2b-47b1-9bfa-a60d54e23dee_7b93552c-af49-47e8-94fa-384ada37c642.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Linalool,78-70-6,"In the key GLP compliant, subchronic oral feeding study according to OECD guideline 408, the no-observed-adverse-effect level (NOAEL) for administration of the test item in the diet was determined to be of 497.9 and 532.1 mg/kg/day for male and female Sprague-Dawley rats, respectively, based on adjusted intake levels in the dietary matrix of the highest dose tested.   In a supporting GLP compliant 28-day oral toxicity study equivalent to OECD 407 in rats, the NOAEL was found to be 117 mg/kg bw/day.   In a GLP compliant 90-day dermal toxicity study equivalent to OECD guideline 411 in rats, the NOAEL was found to be 250 mg/kg bw/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline study with acceptable restrictions Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline study ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26da9cbc-6f61-449e-957d-e33c5d492fa0/documents/IUC5-c9ace93b-2386-48cc-838f-7b90942de745_3415efe3-daa9-460a-95af-c6d188a3952b.html,,,,,, Linalool,78-70-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26da9cbc-6f61-449e-957d-e33c5d492fa0/documents/IUC5-c9ace93b-2386-48cc-838f-7b90942de745_3415efe3-daa9-460a-95af-c6d188a3952b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,497.9 mg/kg bw/day,,rat Linalool,78-70-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26da9cbc-6f61-449e-957d-e33c5d492fa0/documents/IUC5-c9ace93b-2386-48cc-838f-7b90942de745_3415efe3-daa9-460a-95af-c6d188a3952b.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,250 mg/kg bw/day,,rat Linalool,78-70-6,"Acute toxicity oral: - Standard acute method (Mouse): LD50 approx. 2200 mg/kg bw (comparable to deleted OECD 401). - Standard acute method (Rat): LD50 2790 mg/kg bw (similar to deleted OECD 401). Acute toxicity inhalation: - Inhalation study under standardized conditions (Mouse): 73% decrease in motility (20-50 mg, 1-hour). - Inhalation study under standardized conditions (Mouse): LC50 >3.2 mg/L (3200 mg/m³). Acute toxicity dermal: - Standard acute method (Rabbit): LD50 5610 mg/kg bw (similar to OECD 402). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Study well documented, meets generally accepted scientific principles, acceptable for assessment Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Study well documented, meets generally accepted scientific principles, acceptable for assessment Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Comparable to guideline study with acceptable restrictions ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26da9cbc-6f61-449e-957d-e33c5d492fa0/documents/IUC5-d9586f67-6e8d-4fcf-b606-7e791f169ac9_3415efe3-daa9-460a-95af-c6d188a3952b.html,,,,,, Linalool,78-70-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26da9cbc-6f61-449e-957d-e33c5d492fa0/documents/IUC5-d9586f67-6e8d-4fcf-b606-7e791f169ac9_3415efe3-daa9-460a-95af-c6d188a3952b.html,,oral,LD50,"2,200 mg/kg bw",no adverse effect observed, Linalool,78-70-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26da9cbc-6f61-449e-957d-e33c5d492fa0/documents/IUC5-d9586f67-6e8d-4fcf-b606-7e791f169ac9_3415efe3-daa9-460a-95af-c6d188a3952b.html,,dermal,LD50,"5,610 mg/kg bw",no adverse effect observed, Linalool,78-70-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26da9cbc-6f61-449e-957d-e33c5d492fa0/documents/IUC5-d9586f67-6e8d-4fcf-b606-7e791f169ac9_3415efe3-daa9-460a-95af-c6d188a3952b.html,,inhalation,discriminating conc.,"> 3,200 mg/m3",no adverse effect observed, "1,6-Octadien-3-ol, 3,7-dimethyl-, acid-isomerized",73018-51-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch 1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3cbad7e0-1474-43c9-95f7-0e470c8f598f/documents/62d243b6-eb6f-4dd5-b062-1d6f457a8558_60fffc30-8dbe-4442-9be7-938e42741224.html,,,,,, "1,6-Octadien-3-ol, 3,7-dimethyl-, acid-isomerized",73018-51-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3cbad7e0-1474-43c9-95f7-0e470c8f598f/documents/62d243b6-eb6f-4dd5-b062-1d6f457a8558_60fffc30-8dbe-4442-9be7-938e42741224.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 2-(tetrahydro-5-methyl-5-vinyl-2-furyl)propan-2-ol,60047-17-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 4 studies. Acceptable for classification. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f61b70d-7ceb-40c8-8567-65ec38aa15e3/documents/IUC5-38ebc8d3-fde1-4073-9576-133a44f5b340_fdbbc3a4-eb0b-489a-81f0-ca415b3f00ec.html,,,,,, 2-(tetrahydro-5-methyl-5-vinyl-2-furyl)propan-2-ol,60047-17-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f61b70d-7ceb-40c8-8567-65ec38aa15e3/documents/IUC5-38ebc8d3-fde1-4073-9576-133a44f5b340_fdbbc3a4-eb0b-489a-81f0-ca415b3f00ec.html,,oral,LD50,"1,150 mg/kg bw",adverse effect observed, Linalyl acetate,115-95-7,"Repeated dose toxicity - oral: 28 d, rat, gavage: NOAEL = 117 mg/kg bw/day (similar to OECD 407, GLP; HLA642-460; Read-Across to CAS No. 78-70-6)Repeated dose toxicity - oral: 28 d, rat, gavage: NOAEL = 200 mg/kg bw/day (according to OECD 407, GLP; (DSM B-158`884) Read-Across to CAS No.29171-20-8Repeated dose toxicity - dermal: 90 d, rat, open: NOAEL = 250 mg/kg bw/d (Similar to OECD 411, GLP; T&O 79-201; Read-Across to CAS No. 78-70-6) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab3b3a1a-b5f9-47d7-8244-9933daf2b712/documents/IUC5-1e1d917f-2272-49b7-8b3b-3882dc532862_4053b028-e8ce-4194-8b8e-5a2195bc58dc.html,,,,,, Linalyl acetate,115-95-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab3b3a1a-b5f9-47d7-8244-9933daf2b712/documents/IUC5-1e1d917f-2272-49b7-8b3b-3882dc532862_4053b028-e8ce-4194-8b8e-5a2195bc58dc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,117 mg/kg bw/day,,rat Linalyl acetate,115-95-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab3b3a1a-b5f9-47d7-8244-9933daf2b712/documents/IUC5-1e1d917f-2272-49b7-8b3b-3882dc532862_4053b028-e8ce-4194-8b8e-5a2195bc58dc.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,250 mg/kg bw/day,,rat Linalyl acetate,115-95-7,- Oral: Rat LD50 > 9000 mg/kg bw (BASF AG 1969)- Dermal: Rabbit: LD50 > 5000 mg/kg bw linalyl acetate (Moreno 1972) Rabbit: LD50 = 5610 mg/kg bw linalool (Fogleman 1970) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab3b3a1a-b5f9-47d7-8244-9933daf2b712/documents/IUC5-90e4e175-86d1-4fdd-ab28-cf9873dcbd9c_4053b028-e8ce-4194-8b8e-5a2195bc58dc.html,,,,,, "Lipase, triacylglycerol",9001-62-1," The repeated dose oral toxicity was a subchronic toxicity test conducted according to OECD guideline 408 (adopted 1998), and in compliance with GLP. The conclusion was that the No Observed Adverse Effect Level (NOAEL) in rats was the highest dose level tested, equivalent to 10 mL of undiluted test material/kg bw/day or 1248.3 mg enzyme concentrate dry matter/kg bw/day. The repeated dose inhalation and dermal toxicity studies were waived. - The dermal study was waived because of the low likelihood of absorption of enzymes through the skin due to the physico-chemical properties of the enzyme protein. - The inhalation study was waived because exposure is too low to exert any toxicity. Potential exposure by inhalation to an amount of enzyme that toxicologically relevant is unrealistic, due to the formulation of enzymes and the stringent work practices, enforced because of the risk of sensitisation by inhalation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d72cf61f-19ee-4f95-b273-79c6c43b1052/documents/IUC5-f9daf4b1-58c2-4d74-96ca-c233f2c0b18a_a5cfc64e-8696-42db-9bfc-cc63c5d52c45.html,,,,,, "Lipase, triacylglycerol",9001-62-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d72cf61f-19ee-4f95-b273-79c6c43b1052/documents/IUC5-f9daf4b1-58c2-4d74-96ca-c233f2c0b18a_a5cfc64e-8696-42db-9bfc-cc63c5d52c45.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,248.3 mg/kg bw/day",,rat "Lipase, triacylglycerol",9001-62-1, Acute toxicity via the oral route has been tested. No signs of toxicity were observed in ten rats treated with a single oral dose of 2740 mg enzyme concentrate dry matter/kg bw (equivalent to 1940 mg active enzyme protein/kg bw). The test was conducted according to OECD guidelines and GLP standards. Acute toxicity via the inhalation and dermal route is waived based on exposure considerations and the known properties of the substance. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d72cf61f-19ee-4f95-b273-79c6c43b1052/documents/IUC5-d05c73da-5db8-475d-a279-4318425203dc_a5cfc64e-8696-42db-9bfc-cc63c5d52c45.html,,,,,, Storax (balsam),8046-19-3, OECDTG 423: Oral LD50 > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c3dffbf-7950-4e2d-8df8-d23ce919cd7f/documents/2f8ceda7-22b3-4012-b27d-b3d277bfcf36_a5303492-8d13-4e7b-8e97-92cde48a2144.html,,,,,, Storax (balsam),8046-19-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c3dffbf-7950-4e2d-8df8-d23ce919cd7f/documents/2f8ceda7-22b3-4012-b27d-b3d277bfcf36_a5303492-8d13-4e7b-8e97-92cde48a2144.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Lithium carbonate,554-13-2,"Based on human data obtained from long–term routine treatment of bipolar disorder with lithium carbonate, a NOAEL for long-term oral toxicity of 6.43 mg lithium carbonate/kg bw/day was calculated. The MAK value (Maximum Workplace Concentration value, Germany) for lithium and its organic salts is available for workers. Based on the data evaluation of the MAK commission a systemic effect is not expected at a MAK value of 1 mg/m3 lithium carbonate. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06e6b733-be55-4da3-b7ec-744388551183/documents/6a434bcc-277b-432c-b63f-ed7e1ae6a002_6f0e177e-0d2c-4762-82ba-7d588789b801.html,,,,,, Lithium carbonate,554-13-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06e6b733-be55-4da3-b7ec-744388551183/documents/6a434bcc-277b-432c-b63f-ed7e1ae6a002_6f0e177e-0d2c-4762-82ba-7d588789b801.html,Chronic toxicity – systemic effects,oral,NOAEL,6.43 mg/kg bw/day,,other:human Lithium carbonate,554-13-2,"Acute toxicity data are available for all three ways of exposure: LD50 (rat, oral): 525 mg/kg bw LD50 (rat, inhalation): > 2000 mg/m³ LD50 (rabbit, dermal): > 3000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06e6b733-be55-4da3-b7ec-744388551183/documents/3dc396d7-a70b-4d1a-b7f1-0ab0f8013b70_6f0e177e-0d2c-4762-82ba-7d588789b801.html,,,,,, Lithium carbonate,554-13-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06e6b733-be55-4da3-b7ec-744388551183/documents/3dc396d7-a70b-4d1a-b7f1-0ab0f8013b70_6f0e177e-0d2c-4762-82ba-7d588789b801.html,,oral,LD50,525 mg/kg bw,adverse effect observed, Lithium carbonate,554-13-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06e6b733-be55-4da3-b7ec-744388551183/documents/3dc396d7-a70b-4d1a-b7f1-0ab0f8013b70_6f0e177e-0d2c-4762-82ba-7d588789b801.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, Lithium carbonate,554-13-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06e6b733-be55-4da3-b7ec-744388551183/documents/3dc396d7-a70b-4d1a-b7f1-0ab0f8013b70_6f0e177e-0d2c-4762-82ba-7d588789b801.html,,inhalation,LC50,"2,000 mg/m3",no adverse effect observed, Lithium chloride,7447-41-8," The long-term oral lithium chloride NOAEL was based on the long-term oral (human) NOAEL/ DNEL determined for lithium, as the toxicological relevance of chloride linked to the uptake of lithium chloride is regarded as very low. Thus, the long-term oral NOAEL of lithium chloride was based on the worst-case/ toxicological limiting value and was calculated to be 7.32 mg lithium chloride/ kg bw/day. Performance of repeated dermal and inhalation toxicity studies were waived. For CSA requirements NOAEL for long-term dermal toxicity and NOAEC for long-term inhalation toxicity were calculated based on the NOAEL long-term oral value. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ce152e9-d5f4-45a9-abf2-fcb00249f1a6/documents/412247d6-2945-472e-9142-f1251af2e4c9_75209821-e3dd-4779-a2d6-4ccd73740347.html,,,,,, Lithium chloride,7447-41-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ce152e9-d5f4-45a9-abf2-fcb00249f1a6/documents/412247d6-2945-472e-9142-f1251af2e4c9_75209821-e3dd-4779-a2d6-4ccd73740347.html,Chronic toxicity – systemic effects,oral,NOAEL,7.32 mg/kg bw/day,,other:human Lithium chloride,7447-41-8,"Acute toxicity data are available for all three ways of exposure:LD50 (rat, oral): 526 mg/kg bwLD50 (rat, dermal): > 2000 mg/kg bwLD50 (rat, inhalation): 5570 mg/m³ ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ce152e9-d5f4-45a9-abf2-fcb00249f1a6/documents/4104dfe1-6e64-4afd-b673-b6cd543ada27_75209821-e3dd-4779-a2d6-4ccd73740347.html,,,,,, Lithium chloride,7447-41-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ce152e9-d5f4-45a9-abf2-fcb00249f1a6/documents/4104dfe1-6e64-4afd-b673-b6cd543ada27_75209821-e3dd-4779-a2d6-4ccd73740347.html,,oral,LD50,526 mg/kg bw,adverse effect observed, Lithium chloride,7447-41-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ce152e9-d5f4-45a9-abf2-fcb00249f1a6/documents/4104dfe1-6e64-4afd-b673-b6cd543ada27_75209821-e3dd-4779-a2d6-4ccd73740347.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Lithium chloride,7447-41-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ce152e9-d5f4-45a9-abf2-fcb00249f1a6/documents/4104dfe1-6e64-4afd-b673-b6cd543ada27_75209821-e3dd-4779-a2d6-4ccd73740347.html,,inhalation,LC50,"5,570 mg/m3",no adverse effect observed, "Silicic acid, lithium magnesium sodium salt",53320-86-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97b34c53-01c7-49ad-a1de-1c20e3555120/documents/IUC5-e68443eb-f590-4510-af44-853d68cf3104_daf3772e-12cf-438b-8bb4-78579c20e65b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Silicic acid, lithium magnesium sodium salt",53320-86-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97b34c53-01c7-49ad-a1de-1c20e3555120/documents/IUC5-e5e5df2a-b68b-4dba-8328-3bfd07b912af_daf3772e-12cf-438b-8bb4-78579c20e65b.html,,oral,LD50,"2,000 mg/kg bw",, "Silicic acid, lithium magnesium sodium salt",53320-86-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97b34c53-01c7-49ad-a1de-1c20e3555120/documents/IUC5-e5e5df2a-b68b-4dba-8328-3bfd07b912af_daf3772e-12cf-438b-8bb4-78579c20e65b.html,,dermal,LD50,"2,000 mg/kg bw",, "Silicic acid, lithium magnesium sodium salt",53320-86-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97b34c53-01c7-49ad-a1de-1c20e3555120/documents/IUC5-e5e5df2a-b68b-4dba-8328-3bfd07b912af_daf3772e-12cf-438b-8bb4-78579c20e65b.html,,inhalation,LC50,200 mg/m3,, Lithium myristate,20336-96-3,"OECD 422 combined repeat dose and reproductive toxicity screening studies have been conducted on key substances which fall in the definition of the Lithium salts of monocarboxylic acids C14-C22 category. Studies were conducted via oral gavage on lithium myristate, fatty acids C16-18 lithium salts and fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. A study via dietary administration was conducted on lithium 12-hydroxystearate and a dermal study was conducted on fatty acids C18-(unsaturated) lithium salts. The NOAEL was >=500 mg/kg body weight/day for lithium myristate and fatty acids C16-18 lithium salts and was 250 mg/kg body weight/day for fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. The NOAEL for lithium 12-hydroxystearate was 2000 ppm (144 and 161 mg/kg body weight/day for males and females, respectively) based on parental body weights. The NOAEL for fatty acids C18-(unsaturated) lithium salts was 1089.75 mg/kg body weight/day based on systemic effects and 111.25 mg/kg body weight/day based on dermal scores. The results for the tested substances have been read across to the other members of the lithium salts of monocarboxylic acids C14-C22 category. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edbc6e03-c213-40fb-bac9-454eee710175/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_0eef1a92-2b7a-489f-aac6-38514005caba.html,,,,,, Lithium myristate,20336-96-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edbc6e03-c213-40fb-bac9-454eee710175/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_0eef1a92-2b7a-489f-aac6-38514005caba.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,144 mg/kg bw/day,,rat Lithium myristate,20336-96-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edbc6e03-c213-40fb-bac9-454eee710175/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_0eef1a92-2b7a-489f-aac6-38514005caba.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,089.75 mg/kg bw/day",,rat Lithium myristate,20336-96-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edbc6e03-c213-40fb-bac9-454eee710175/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_0eef1a92-2b7a-489f-aac6-38514005caba.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.86 mg/cm2,adverse effect observed,rat Lithium myristate,20336-96-3,"Oral acute toxicity studies in rats were conducted on lithium myristate, fatty acids C18-(unsaturated) lithium salts, lithium docosanoate, and fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. All studies reported no mortality and LD50 values greater than 2000 mg/kg bodyweight. These data have been read across to the other substances in the lithium salts of monocarboxylic acids C14-C22 category. A dermal toxicity study in rats was conducted on fatty acids C18-(unsaturated) lithium salts. The study reported no mortality and LD50 values greater than 2000 mg/kg bodyweight. These data have been read across to the other substances in the lithium salts of monocarboxylic acids C14-C22 category. An estimate of the inhalation dust/mist toxicity by route-to-route extrapolation using conservative standard default values results in an ATE of 10.4 mg/L/4 hours minimum. This value is well above the cut values for classification for acute inhalation toxicity hazard. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edbc6e03-c213-40fb-bac9-454eee710175/documents/754e9131-4245-46c3-8876-e6b64b352e18_0eef1a92-2b7a-489f-aac6-38514005caba.html,,,,,, Lithium myristate,20336-96-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edbc6e03-c213-40fb-bac9-454eee710175/documents/754e9131-4245-46c3-8876-e6b64b352e18_0eef1a92-2b7a-489f-aac6-38514005caba.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Lithium myristate,20336-96-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edbc6e03-c213-40fb-bac9-454eee710175/documents/754e9131-4245-46c3-8876-e6b64b352e18_0eef1a92-2b7a-489f-aac6-38514005caba.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Lithium stearate,4485-12-5,"OECD 422 combined repeat dose and reproductive toxicity screening studies have been conducted on key substances which fall in the definition of the Lithium salts of monocarboxylic acids C14-C22 category. Studies were conducted via oral gavage on lithium myristate, fatty acids C16-18 lithium salts and fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. A study via dietary administration was conducted on lithium 12-hydroxystearate and a dermal study was conducted on fatty acids C18-(unsaturated) lithium salts. The NOAEL was >=500 mg/kg body weight/day for lithium myristate and fatty acids C16-18 lithium salts and was 250 mg/kg body weight/day for fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. The NOAEL for lithium 12-hydroxystearate was 2000 ppm (144 and 161 mg/kg body weight/day for males and females, respectively) based on parental body weights. The NOAEL for fatty acids C18-(unsaturated) lithium salts was 1089.75 mg/kg body weight/day based on systemic effects and 111.25 mg/kg body weight/day based on dermal scores. The results for the tested substances have been read across to the other members of the lithium salts of monocarboxylic acids C14-C22 category. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8cebe03-80ce-41f0-8091-921b9a933d07/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_dd43074d-82a1-4354-9dee-bdfb0f93f535.html,,,,,, Lithium stearate,4485-12-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8cebe03-80ce-41f0-8091-921b9a933d07/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_dd43074d-82a1-4354-9dee-bdfb0f93f535.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,144 mg/kg bw/day,,rat Lithium stearate,4485-12-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8cebe03-80ce-41f0-8091-921b9a933d07/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_dd43074d-82a1-4354-9dee-bdfb0f93f535.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,089.75 mg/kg bw/day",,rat Lithium stearate,4485-12-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8cebe03-80ce-41f0-8091-921b9a933d07/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_dd43074d-82a1-4354-9dee-bdfb0f93f535.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.86 mg/cm2,adverse effect observed,rat Lithium stearate,4485-12-5,"Oral acute toxicity studies in rats were conducted on lithium myristate, fatty acids C18-(unsaturated) lithium salts, lithium docosanoate, and fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. All studies reported no mortality and LD50 values greater than 2000 mg/kg bodyweight. These data have been read across to the other substances in the lithium salts of monocarboxylic acids C14-C22 category. A dermal toxicity study in rats was conducted on fatty acids C18-(unsaturated) lithium salts. The study reported no mortality and LD50 values greater than 2000 mg/kg bodyweight. These data have been read across to the other substances in the lithium salts of monocarboxylic acids C14-C22 category. An estimate of the inhalation dust/mist toxicity by route-to-route extrapolation using conservative standard default values results in an ATE of 10.4 mg/L/4 hours minimum. This value is well above the cut values for classification for acute inhalation toxicity hazard. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8cebe03-80ce-41f0-8091-921b9a933d07/documents/754e9131-4245-46c3-8876-e6b64b352e18_dd43074d-82a1-4354-9dee-bdfb0f93f535.html,,,,,, Lithium stearate,4485-12-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8cebe03-80ce-41f0-8091-921b9a933d07/documents/754e9131-4245-46c3-8876-e6b64b352e18_dd43074d-82a1-4354-9dee-bdfb0f93f535.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Lithium stearate,4485-12-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8cebe03-80ce-41f0-8091-921b9a933d07/documents/754e9131-4245-46c3-8876-e6b64b352e18_dd43074d-82a1-4354-9dee-bdfb0f93f535.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Lupine, L. albus, ext.",84082-55-3," In an OECD guideline 423 study on rats, the LD50 of the test item IN 04 is higher than 2000 mg/kg body weight by oral route. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ed032f1-d3c1-4d6c-ba3c-228adeacee9b/documents/90370ac1-1892-4c14-9cec-747afb7d7b6a_d19daa46-ef6a-47b2-9580-bd7e19eb7bed.html,,,,,, "Lupine, L. albus, ext.",84082-55-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ed032f1-d3c1-4d6c-ba3c-228adeacee9b/documents/90370ac1-1892-4c14-9cec-747afb7d7b6a_d19daa46-ef6a-47b2-9580-bd7e19eb7bed.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "L-lysine, compound with S-(carboxymethyl)-L-cysteine (1:1)",49673-81-6, LD50 > 2000 mg/kg upon oral exposure. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b33cf5d1-67cf-49b1-a06f-197ba197dab6/documents/c3d6d312-581d-4b54-9119-0abfe46f69f2_c17b540a-8246-4c25-aa76-246d1ceffdec.html,,,,,, Lysine hydrochloride,657-27-2,"Two reliable 28-day and two reliable 90-day studies are available. In the 28-day key study (Fabreguettes, 1998) performed according to OECD 407 the NOEL of L-lysine HCl is 1940 mg/kg bw/d for rats (limit test), based on the absence of toxicologically adverse effects. In a second 28-day study (Neda, 2001) there were no treatment-related adverse findings in this study, but there were treatment-related findings at high dose. The urinalysis showed an increasing tendency of lowered urinary pH value and a significant increase of total excretion amount of chlorine in both males and females in the 50000 ppm group. These changes were considered to be attributable to the fact that the test substance was a hydrochloric salt. However, the findings were considered to have no toxicological significance because no changes were observed in the serum potassium measured in the blood biochemistry examination. At the end of the administration period, a significant increase of relative weight of pituitary gland was noted in females in 12500 ppm and 25000 ppm groups, and significant  increases of absolute and relative weights of right kidney were noted in a female in 50000 ppm group, which were not considered to be treatment-related in the absence of a microscopic correlate. Based on the results of this study, i.e. no toxicologically significant changes were observed even in the group administered with Lysine hydrochloride at 50000 ppm level, the no-observable-effect-level (NOEL) for Lysine hydrochloride under the conditions of this study was considered to be 50000 ppm, corresponding to an average test compound intake of 4279 and 4487 mg/kg/day for males and females, respectively.  In the 90-day key study (Mommers, 2003) performed according to OECD 408 there were considered to be findings of toxicological significance at high dose in this study. However, the decreased spleen weights at high dose in males (considered to be related to treatment) had no morphological correlate and can not be regarded as an adverse effect. The NOAEL may therefore actually be a dietary concentration of 5% (mean achieved dosage of 3002 and 3173 mg/kg bw/day for males and females, respectively). The decreased urinary pH for mid- and high dose males and high-dose females appears to be related to the administration of large quantities of an HCl salt. In the second 90-day toxicity study (Tsubuku, 2004) the concentration of 5% lysine in dietary mixture corresponding to a mean achieved dosage of 3360 and 3990 mg/kg bw/day for males and females, respectively, was considered as No-Observable-Adverse-Effect-Level (NOAEL) in a 90-day study in Sprague- Dawley rats. There were considered to be no findings of toxicological significance in this study. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4634aebd-e184-4b66-a703-58b94ff44f8c/documents/IUC5-582b6848-7333-428f-bfde-8c496161820f_4869fdfd-1a1a-453d-9984-00e3774efd3b.html,,,,,, Lysine hydrochloride,657-27-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4634aebd-e184-4b66-a703-58b94ff44f8c/documents/IUC5-582b6848-7333-428f-bfde-8c496161820f_4869fdfd-1a1a-453d-9984-00e3774efd3b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,914 mg/kg bw/day,,rat Lysine hydrochloride,657-27-2,An acute oral LD50 value of 10600 mg/kg bw from a reliable study was derived. A limit study for acute inhalation performed according to OECD 403 resulted in an LC50 value of >5000 mg/m3. The acute dermal study was waived based on the presence of an inhalation study for the second route of exposure. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4634aebd-e184-4b66-a703-58b94ff44f8c/documents/IUC5-0c067b59-0ef6-4e13-8eb4-9cf183926e5d_4869fdfd-1a1a-453d-9984-00e3774efd3b.html,,,,,, Lysine hydrochloride,657-27-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4634aebd-e184-4b66-a703-58b94ff44f8c/documents/IUC5-0c067b59-0ef6-4e13-8eb4-9cf183926e5d_4869fdfd-1a1a-453d-9984-00e3774efd3b.html,,oral,LD50,"10,600 mg/kg bw",, Lysine hydrochloride,657-27-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4634aebd-e184-4b66-a703-58b94ff44f8c/documents/IUC5-0c067b59-0ef6-4e13-8eb4-9cf183926e5d_4869fdfd-1a1a-453d-9984-00e3774efd3b.html,,inhalation,LC50,"5,000 mg/m3",, 3-aminophenol,591-27-5,"Repeated dose toxicity - Oral In a study by L’Oreal (1996), female 6-week-old Sprague-Dawley rats were exposed to 3-aminophenol daily for 13 weeks at 0, 20, 70, 200 and 600 mg/kg bw/day by oral gavage administration. No effects were observed at 20 mg/kg. From 70 mg/kg, there was a dose-related increase in thyroid hyperactivity in both male and females based on microscopic evaluation. At 70 mg/kg, the increase in thyroid function was observed in 2 (of the 10) males and in 2 (of the 10 females). This effect was not considered toxicologically relevant, due to the well-established relationship between increased thyroid hyperactivity and increased functional demand of the liver due to chemical dosing. In comparison to the controls, marked hemosiderosis was noted in the rats treated at 200 mg/kg. This was accompanied by slight changes in biochemistry parameters, i.e. slightly higher total protein levels in blood, slightly lower glucose levels in blood and slightly lower red blood cell count in blood. Based on the data, NOAEL for the test chemical was considered at 70 mg/kg bw/day in this 13 -weeks study. Serious effects occured at 600 mg/kg bw/day.   Repeated dose toxicity - Inhalation   3-aminophenol (CAS no. 591-27-5)has very a low vapor pressure of0.248 Pa at 25°C. The particle size distribution was determined to be in the range of 500 micrometer to 1000 micrometer. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely. Therefore this end point for repeated dose toxicity by inhalation route is considered for waiver   Repeated dose toxicity - Dermal In a study by L’Oreal (1979) male and female Charles river rats were exposed by dermal route two times per week for 24 months to hair dye formulations P-26 or P-25. Each topical application contained a 3-aminophenol concentration of approximately 0.59 mg/kg (for P-26) and 2.65 mg/kg (for P-25). The terminal body weight was marginally lower (9.4% lower) in the females in the P-25 treatment group as compared to the controls. Food consumption was slightly higher in the treated rats as compared to the controls. No gross lesions were considered to be compound-related. In the P-25 treatment group, hyperkeratosis and/or acanthosis of the stomach mucosa was considered to be possibly compound-related. Hepatocellular hypertrophy/hyperplasia or formation of hyperplastic/hypertrophic nodules in the livers of the rats in the P-25 treatment group (most notably in males) was also considered to be possibly compound-related. The incidence of liver hematopoiesis in both sexes in the P-25 treatment group was moderately higher as compared to the controls. This effect was of doubtful clinical significance due to absence of increased incidence of hematopoiesis in other blood forming organs. The incidence of testicular seminiferous tubular atrophy or degeneration in male rats in the P-25 and P-26 treatment groups was also of doubtful clinical significance due to historical control data of the laboratory. There were no significant changes in hematology parameters, blood biochemistry or in urine. There were also no significant changes in general behavior or food intake. NOAEL for the test chemical was found at the 0.59 mg/kg dose level. No serious effects occured at the highest dose level of 2.65 mg/kg. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01b98f7f-6cc9-466d-8a5e-2743b2117ab9/documents/f0022023-3090-4b71-98c2-a6742652f944_532c97ba-9e41-4a26-8243-f396d7ebd757.html,,,,,, 3-aminophenol,591-27-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01b98f7f-6cc9-466d-8a5e-2743b2117ab9/documents/f0022023-3090-4b71-98c2-a6742652f944_532c97ba-9e41-4a26-8243-f396d7ebd757.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,70 mg/kg bw/day,,rat 3-aminophenol,591-27-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01b98f7f-6cc9-466d-8a5e-2743b2117ab9/documents/f0022023-3090-4b71-98c2-a6742652f944_532c97ba-9e41-4a26-8243-f396d7ebd757.html,Chronic toxicity – systemic effects,dermal,LOAEL,0.59 mg/kg bw/day,,rat 3-aminophenol,591-27-5,"Acute oral toxicity:  Acute oral toxicity dose (LD50) was considered based on different experimental studies conducted on rats and mice for the given test chemical. The LD50 value is considered to be >500 mg/kg in rats. The study concluded that the LD50 value is between 300-2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity.   Acute Inhalation toxicity:  Acute Inhalation toxicity dose (LC50) was considered based on experimental study conducted on rats for the given test chemical. The LC50 value is considered to be 1162 mg/m3 (1.162 mg/L). The study concluded that the LC50 value is between 1.0-5.0 mg/L. Thus, comparing this value with the criteria of CLP regulation, test chemical can be classified in “Category 4” for acute inhalation toxicity.   Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) was considered based on experimental study conducted on rabbits for the given test chemical. The LD50 value is considered to be 8112 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01b98f7f-6cc9-466d-8a5e-2743b2117ab9/documents/eb5aada2-e812-4edb-ae55-5a7a6ceabdbf_532c97ba-9e41-4a26-8243-f396d7ebd757.html,,,,,, 3-aminophenol,591-27-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01b98f7f-6cc9-466d-8a5e-2743b2117ab9/documents/eb5aada2-e812-4edb-ae55-5a7a6ceabdbf_532c97ba-9e41-4a26-8243-f396d7ebd757.html,,oral,LD50,500 mg/kg bw,adverse effect observed, 3-aminophenol,591-27-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01b98f7f-6cc9-466d-8a5e-2743b2117ab9/documents/eb5aada2-e812-4edb-ae55-5a7a6ceabdbf_532c97ba-9e41-4a26-8243-f396d7ebd757.html,,dermal,LD50,"8,112 mg/kg bw",no adverse effect observed, 3-aminophenol,591-27-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01b98f7f-6cc9-466d-8a5e-2743b2117ab9/documents/eb5aada2-e812-4edb-ae55-5a7a6ceabdbf_532c97ba-9e41-4a26-8243-f396d7ebd757.html,,inhalation,LC50,"1,162 mg/m3",adverse effect observed, m-cresol,108-39-4," In a study according to OECD TG 408, male and female Sprague Dawley rats received 0, 50, 150, 450 mg/kg bw/day m-cresol diluted in corn oil for a period of 13 weeks by gavage. At 450 mg/kg bw male and female rats displayed lethargy, tremors, hunched posture and rough fur post dosing. Dose-dependant body weight decrease resulted in a NOAEL (male rat ) of 50 mg/kg bw/day. The NOAEL (female rat) was 150 mg/kg bw/day based on reduced body weight gain in the highest dose group (RTI 1988). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf31ceee-78af-45f5-bf5d-1dcdd173eec4/documents/IUC5-78ef3d20-6b63-4354-84de-7633382319b3_76556219-2720-4b82-adef-2a7c6e6dcfde.html,,,,,, m-cresol,108-39-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf31ceee-78af-45f5-bf5d-1dcdd173eec4/documents/IUC5-78ef3d20-6b63-4354-84de-7633382319b3_76556219-2720-4b82-adef-2a7c6e6dcfde.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat m-cresol,108-39-4," Following single oral treatment of rats LD50 is 242 mg/kg bw. Follwing dermal application to rabbits the LD50 was 2050 mg/kg bw. Clinical signs included hypoactivity, salivation, tremors and convulsions. The skin of dermal treated rabbits show additionally severe erythema and burns. The databases on acute inhalation toxicity of m-cresol in animals is very limited and does not allow final conclusion. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf31ceee-78af-45f5-bf5d-1dcdd173eec4/documents/IUC5-9ecc2927-3702-4e77-89b1-c73b3d598b3b_76556219-2720-4b82-adef-2a7c6e6dcfde.html,,,,,, m-cresol,108-39-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf31ceee-78af-45f5-bf5d-1dcdd173eec4/documents/IUC5-9ecc2927-3702-4e77-89b1-c73b3d598b3b_76556219-2720-4b82-adef-2a7c6e6dcfde.html,,oral,LD50,242 mg/kg bw,adverse effect observed, m-cresol,108-39-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf31ceee-78af-45f5-bf5d-1dcdd173eec4/documents/IUC5-9ecc2927-3702-4e77-89b1-c73b3d598b3b_76556219-2720-4b82-adef-2a7c6e6dcfde.html,,dermal,LD50,"2,050 mg/kg bw",adverse effect observed, m-phenylenediamine,108-45-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18f44fea-4cb0-432e-80c3-824d216949ff/documents/IUC5-5b270c91-ff87-4fba-9128-2b5af9c2425e_d9cffe8c-34c9-4455-a87b-88c70e501c30.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,6 mg/kg bw/day,,rat m-phenylenediamine,108-45-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18f44fea-4cb0-432e-80c3-824d216949ff/documents/IUC5-61d8360a-48e5-40ca-bd45-b39d7398a2dc_d9cffe8c-34c9-4455-a87b-88c70e501c30.html,,oral,discriminating dose,450 mg/kg bw,adverse effect observed, m-phenylenediamine,108-45-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18f44fea-4cb0-432e-80c3-824d216949ff/documents/IUC5-61d8360a-48e5-40ca-bd45-b39d7398a2dc_d9cffe8c-34c9-4455-a87b-88c70e501c30.html,,dermal,discriminating dose,"1,500 mg/kg bw",adverse effect observed, m-phenylenediamine,108-45-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18f44fea-4cb0-432e-80c3-824d216949ff/documents/IUC5-61d8360a-48e5-40ca-bd45-b39d7398a2dc_d9cffe8c-34c9-4455-a87b-88c70e501c30.html,,inhalation,LC50,"3,200 mg/m3",adverse effect observed, Magnesium di(acetate),142-72-3,"Repeated dose toxicity: oral:Weight of evidence: Read-across from experimental results from no-standard studies on rats with Sodium Acetate and Citric acid, sodium salt. All these studies showed no signs of toxicity, even though in one study, the limit dose was exceeded. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a0b733c-74c7-4e8d-b54c-6519caae7365/documents/IUC5-b096ed0d-8d1d-4119-8e1e-b5e612e10ec3_0d63034f-ba95-4618-8826-d747042deea3.html,,,,,, Magnesium di(acetate),142-72-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a0b733c-74c7-4e8d-b54c-6519caae7365/documents/IUC5-b096ed0d-8d1d-4119-8e1e-b5e612e10ec3_0d63034f-ba95-4618-8826-d747042deea3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"3,124.71 mg/kg bw/day",,rat Magnesium di(acetate),142-72-3,Acute oral toxicity: Key studies: Read-across from experimental data on the analogue substance Calcium Acetate. The oral LD50 for Magnesium Acetate for female rats is calculated to be 2422 mg/kg bw (test method according to OECD 401).Acute inhalation toxicity: Key studies: Read-across from experimental data on the analogue substance Calcium Acetate. The (4h) LC50 in male/female rats for Magnesium Acetate is calculated to be greater than 5.04 mg/L air (test method equivalent to OECD 403).Acute dermal toxicity: Key studies: Read-across from experimental data on the analogue Fumaric Acid. The LD 50 for Magnesium Acetate is calculated to be greater than 24530.58 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a0b733c-74c7-4e8d-b54c-6519caae7365/documents/IUC5-892281c3-ad50-4dfd-99ad-d6de70bd17e2_0d63034f-ba95-4618-8826-d747042deea3.html,,,,,, Magnesium di(acetate),142-72-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a0b733c-74c7-4e8d-b54c-6519caae7365/documents/IUC5-892281c3-ad50-4dfd-99ad-d6de70bd17e2_0d63034f-ba95-4618-8826-d747042deea3.html,,oral,LD50,"2,422 mg/kg bw",, Magnesium di(acetate),142-72-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a0b733c-74c7-4e8d-b54c-6519caae7365/documents/IUC5-892281c3-ad50-4dfd-99ad-d6de70bd17e2_0d63034f-ba95-4618-8826-d747042deea3.html,,dermal,LD50,"24,530.58 mg/kg bw",, Magnesium di(acetate),142-72-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a0b733c-74c7-4e8d-b54c-6519caae7365/documents/IUC5-892281c3-ad50-4dfd-99ad-d6de70bd17e2_0d63034f-ba95-4618-8826-d747042deea3.html,,inhalation,LC50,"5,040 mg/m3",, "Silicic acid, aluminum magnesium salt",1327-43-1,"Oral: Syloid 244NOAEL (male): 1760 - 3000 mg/kg bw/day for ratsNOAEL (female): 1780 - 3210 mg/kg bw/day for ratsNOAEL (male): 5270 - 7490 mg/kg bw/day for miceNOAEL (female): 3950 - 13310 mg/kg bw/day for miceDermalNo dermal repeated dose toxicity studies.Inhalation: Aerosil 200NOAEC (subchronic, Aerosil 200): 1.3 mg/m ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e575dc85-f608-4ff3-81e3-974bf2de621f/documents/IUC5-50817844-30b0-4c22-a401-49f5d4d6ebbe_97dd671d-fad8-4ec1-96d7-cdb6da36e0f4.html,,,,,, "Silicic acid, aluminum magnesium salt",1327-43-1,"Oral: Silicic acid, aluminium magnesium sodium saltLD50: > 2000 mg/kg bw for rats (Colas 2009)In accordance with the OECD guideline 423, the LD50 cut-off of the test item may be considered higher than 5000 mg/kg bw by oral route in the rat.Inhalation: Synthetic amorphous silica: The acute inhalation of dust may cause local irritation to nasal, bronchiolar and ocular mucous membranes. Synthetic amorphous silica dusts are considered as acutely non-toxic.Dermal: various forms of synthetic amorphous silicaLD50: > 5000 mg/kg bw for rabbit after 14 observation days (Calkins 1978a-e)LD50: > 2000 mg/kg bw for rabbit after 2 observation days (Calkins 1976) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e575dc85-f608-4ff3-81e3-974bf2de621f/documents/IUC5-afbb0d05-f23d-4d98-841c-30adf0cb0b5e_97dd671d-fad8-4ec1-96d7-cdb6da36e0f4.html,,,,,, Magnesium chloride,7786-30-3," Repeated dose toxicity studies have been conducted with magnesium chloride hexahydrate via the oral route. The results have been corrected to magnesium chloride anhydrous. The key study (OECD 422) and the supporting studies observed no oral toxicity for repeated exposure except a decrease in body weight. The rats being the more sensitive species, the LOAEL and NOAEL, for MgCl2 anhydrous, were deduced on it except for 2 years study (only data available for mice). NOAEL (28 days) = 466 mg/kgbw/day - rat NOAEL (90 days) = 140 mg/kgbw/day - rat LOAEL (90 days) = 713 mg/kgbw/day - rat  NOAEL (2 years) = 1309 mg/kgbw/day - mice ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ffb4daf5-b89d-4ee2-8ee9-ec08f3497913/documents/084e0b55-74b2-4f46-9e9b-9f8d8a909b56_6067993e-cf9a-4222-9187-fb0481a46349.html,,,,,, Magnesium chloride,7786-30-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ffb4daf5-b89d-4ee2-8ee9-ec08f3497913/documents/084e0b55-74b2-4f46-9e9b-9f8d8a909b56_6067993e-cf9a-4222-9187-fb0481a46349.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,309 mg/kg bw/day",,mouse Magnesium chloride,7786-30-3," Acute toxicity studies have been conducted with magnesium chloride hexahydrate via the oral and dermal route. The results have been corrected to magnesium chloride anhydrous. Thus: - For oral acute toxicity, the LC50 was > 2330 mg MgCl2/kg bw for Wistar rats (OECD 423). - For dermal acute toxicity, the LC50 was considered as > 2000 mg MgCl2/kg bw for Wistar rats (OECD 402 and toxicity data). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ffb4daf5-b89d-4ee2-8ee9-ec08f3497913/documents/059ecfd0-89a6-4d72-aec4-d7e9b2cb301f_6067993e-cf9a-4222-9187-fb0481a46349.html,,,,,, Magnesium chloride,7786-30-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ffb4daf5-b89d-4ee2-8ee9-ec08f3497913/documents/059ecfd0-89a6-4d72-aec4-d7e9b2cb301f_6067993e-cf9a-4222-9187-fb0481a46349.html,,oral,LD50,"2,330 mg/kg bw",no adverse effect observed, Magnesium chloride,7786-30-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ffb4daf5-b89d-4ee2-8ee9-ec08f3497913/documents/059ecfd0-89a6-4d72-aec4-d7e9b2cb301f_6067993e-cf9a-4222-9187-fb0481a46349.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Magnesium fluoride,7783-40-6," Oral: The oral NOAEL (mice, male, subchronic) 2690 mg/kg bw/day (2.5 % solution) (magnesium chloride) The oral NOAEL (mice, female, subchronic) 3260 mg/kg bw/day (2.5 % solution) (magnesium chloride) The oral NOAEL (rat, females, chronic) 175 mg/kg bw/day (sodium fluoride) The oral NOAEL (rat, male, chronic) 175 mg/kg bw/day (sodium fluoride)   Inhalation: No relevant studies available   Dermal: No relevant studies available ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f26224d6-7a7d-4794-a784-8e876ba5011f/documents/40165c4e-db07-43ce-b2bd-71c557c03a50_5cd4d521-4e7b-487e-910b-7b7539386127.html,,,,,, Magnesium fluoride,7783-40-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f26224d6-7a7d-4794-a784-8e876ba5011f/documents/40165c4e-db07-43ce-b2bd-71c557c03a50_5cd4d521-4e7b-487e-910b-7b7539386127.html,Chronic toxicity – systemic effects,oral,NOAEL,175 mg/kg bw/day,,rat Magnesium fluoride,7783-40-6," Oral exposure There is one good quality guideline compliant acute toxicity study via oral route (OECD 423 - Acute Toxic Class Method) conducted for magnesium fluoride (Hózová, R. 2016). The purpose of the study was to evaluate the potential toxic effect of the test item Magnesium Fluoride after single oral administration to rats. A limit dose of 2000 mg/kg body weight was used as starting dose.In this study, the LD50 value of the substance in the female rats was estimated to be greater than 2000 mg/kg of body weight. In the study of Hózová, R. (2016) three female rats were gavaged with undiluted test substance at a dose level of 2000 mg/kg bw. No mortalities were observed during the test. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. The post exposure period was 14 days. All animals showed expected gains in bodyweight. No abnormalities were noted at necropsy. The acute median lethal dose (LD50) of the test item in female Wistar rat was estimated to be greater than 2000 mg/kg bodyweight. As a conclusion, the results of the key study did not indicate this substance to be classified for acute toxicity via oral route. Inhalation exposure In accordance with column 2 of REACH Annex VIII, testing by the inhalation route is not needed if exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and there is no possibility of exposure to aerosols, particles or droplets of an inhalable size. The vapour pressure of magnesium fluoride is impossible to measure due to the extremely low value.   In addition, PPEs are in use during the use of the substance so there is no risk of exposure to magnesium fluoride via inhalation route. The PPEs and risk management measures are demonstrated in the CSR section 9 and 10. Due to these facts human exposure via inhalation route is not considered likely.   Dermal exposure In accordance with column 2 of REACH Annex VIII the acute toxicity by dermal route is not needed if skin contact in production and use is not likely. The PPEs are worn to protect skin during the use of the substance. The risks for acute systemic effects via dermal route are adequately controlled with the risk management measures presented for long-term systemic effects (see CSR sections 9&10). Based on the in vitro Skin irritation study result (OECD 439) this substance is not irritating to the skin. Due to these facts human exposure via dermal route is not considered likely. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f26224d6-7a7d-4794-a784-8e876ba5011f/documents/111cf236-44d3-40cf-99c3-a7e5ac0524fb_5cd4d521-4e7b-487e-910b-7b7539386127.html,,,,,, Magnesium fluoride,7783-40-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f26224d6-7a7d-4794-a784-8e876ba5011f/documents/111cf236-44d3-40cf-99c3-a7e5ac0524fb_5cd4d521-4e7b-487e-910b-7b7539386127.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Magnesium hexafluorosilicate,16949-65-8,Reliable information on acute oral toxicity indicates that the substance shall be classified according to in force regulations. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1742facb-73a7-438e-8079-87c0fcf376cc/documents/IUC5-eef8a765-7efb-4e65-a07e-0f4bbd09b053_7e4498a5-9ff3-4265-9839-7b37da6834e8.html,,,,,, Magnesium hexafluorosilicate,16949-65-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1742facb-73a7-438e-8079-87c0fcf376cc/documents/IUC5-eef8a765-7efb-4e65-a07e-0f4bbd09b053_7e4498a5-9ff3-4265-9839-7b37da6834e8.html,,oral,LD50,291 mg/kg bw,adverse effect observed, Magnesium hexafluorosilicate,16949-65-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1742facb-73a7-438e-8079-87c0fcf376cc/documents/IUC5-eef8a765-7efb-4e65-a07e-0f4bbd09b053_7e4498a5-9ff3-4265-9839-7b37da6834e8.html,,inhalation,LC50,"3,900 mg/m3",adverse effect observed, Magnesium glycerophosphate,927-20-8," Magnesium glycerophosphate was administered once daily to group of Wistar rats for a period of 28 days at doses of 100, 500 and 1000 mg/kg bodyweight. In the treated animals, no motality and clinical signs of toxicity were observed. There were no treatment related and toxicologically relevant changes in feed consumption, bodyweight gain, haematology, biochemistry, urinary parameters and organ weights. The gross and histopathology did not attribute to the test item Magnesium glycerophosphate at and up to 1000 mg/kg bw dose level in both sexes. Hence under the conditions of the experiment, the highest dose tested i.e., 1000 mg/kg is considered as NOEL (No Oberved Effect Level).   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79675aa7-af52-464b-8b79-2917d3385c34/documents/7349ff5c-5f94-4a8d-8e33-bab56d7f542b_df9e34fe-d424-43a0-bdb6-8c37314e058f.html,,,,,, Magnesium glycerophosphate,927-20-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79675aa7-af52-464b-8b79-2917d3385c34/documents/7349ff5c-5f94-4a8d-8e33-bab56d7f542b_df9e34fe-d424-43a0-bdb6-8c37314e058f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Magnesium glycerophosphate,927-20-8, The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg body weight. Globally Harmonized Classification System: Unclassified. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79675aa7-af52-464b-8b79-2917d3385c34/documents/62d5ec55-a523-457f-ac4d-b809f724e005_df9e34fe-d424-43a0-bdb6-8c37314e058f.html,,,,,, Magnesium glycerophosphate,927-20-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79675aa7-af52-464b-8b79-2917d3385c34/documents/62d5ec55-a523-457f-ac4d-b809f724e005_df9e34fe-d424-43a0-bdb6-8c37314e058f.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Magnesium hydrogenorthophosphate,7757-86-0, There are currently no reliable experimental data available to assess repeated dose toxicity for magnesium hydrogenorthophosphate. A data waiver is set in place to justify that no further repeated dose toxicity testing is required. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57c34665-7125-41b9-bd3c-3033679135ad/documents/e0bc824a-1773-4440-8533-ec3de73f934d_410636c8-2abc-4008-9676-e7062c12d0ea.html,,,,,, Magnesium hydrogenorthophosphate,7757-86-0," Oral (OECD 420, RL1), rat LD50 > 2000 mg/kg bw (limit test) There is no reliable data availabe regarding acute dermal toxicity for magnesium hydrogenorthophosphate. Read across data with calcium bis (dihydrogenorthophosphate) CAS 7758 -23 -8 is used and considered reliable. Dermal (similar to OECD 402, CAS 7758 -23 -8, RL2), rabbit, LD50 > 2000 mg/kg bw (limit test) There is no data regarding acute toxicity via inhalation route available for magnesium hydrogenorthophosphate. Read across data with calcium bis (dihydrogenorthophosphate) CAS 7758 -23 -8 is used and considered reliable. Inhalation (OECD 403, CAS 7758 -23 -8, RL1), rat LC50 > 2.6 mg/L air (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57c34665-7125-41b9-bd3c-3033679135ad/documents/79024020-8d2e-4d81-995b-78e461047033_410636c8-2abc-4008-9676-e7062c12d0ea.html,,,,,, Magnesium hydrogenorthophosphate,7757-86-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57c34665-7125-41b9-bd3c-3033679135ad/documents/79024020-8d2e-4d81-995b-78e461047033_410636c8-2abc-4008-9676-e7062c12d0ea.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Magnesium hydrogenorthophosphate,7757-86-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57c34665-7125-41b9-bd3c-3033679135ad/documents/79024020-8d2e-4d81-995b-78e461047033_410636c8-2abc-4008-9676-e7062c12d0ea.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Magnesium hydrogenorthophosphate,7757-86-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57c34665-7125-41b9-bd3c-3033679135ad/documents/79024020-8d2e-4d81-995b-78e461047033_410636c8-2abc-4008-9676-e7062c12d0ea.html,,inhalation,LC50,"2,600 mg/m3",no adverse effect observed, Magnesium hydroxide,1309-42-8," A combined repeated dose reproductive toxicity screening study (OECD 422) study was performed with magnesium hydroxide to assess sub-acute oral toxicity in rats. No test substance related effects were observed at the highest dose tested which was equal to the limit dose for the repeated dose toxicity test of 1000 mg/kg bw. No data is available to assess the sub-chronic toxicity of the target substance. Therefore, available data from a sub-chronic repeated dose toxicity study conducted with a suitable read-across partner was used in a weight-of-evidence approach to assess the specific target organ toxicity of the target substance. Based on the results, no classification for specific target organ toxicity is warranted for magnesium hydroxide. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a8eb6cc-7c6c-4f6c-8965-1336ba13b9d7/documents/IUC5-d50c861e-3566-4199-8a2d-423698712922_9d07f7e3-268d-4a88-ad67-b552db7fed90.html,,,,,, Magnesium hydroxide,1309-42-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a8eb6cc-7c6c-4f6c-8965-1336ba13b9d7/documents/IUC5-d50c861e-3566-4199-8a2d-423698712922_9d07f7e3-268d-4a88-ad67-b552db7fed90.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,772 mg/kg bw/day,,mouse Magnesium hydroxide,1309-42-8," In an acute oral toxicity study in rats conducted according to OECD 423, no mortality occurred at the dose level 2000 mg/kg bw. Hence, the LD50 was determined to exceed 2000 mg/kg body weight.  In an acute inhalation toxicity study conducted according to OECD 403, the inhalatory LC50 of Magnesium hydroxide in Wistar rats was established to exceed 2.1 mg/L, being this value the maximum feasible concentration that could be tested. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a8eb6cc-7c6c-4f6c-8965-1336ba13b9d7/documents/IUC5-d72642e7-2e18-4cd8-be2f-05b8fe4ccd2b_9d07f7e3-268d-4a88-ad67-b552db7fed90.html,,,,,, Magnesium hydroxide,1309-42-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a8eb6cc-7c6c-4f6c-8965-1336ba13b9d7/documents/IUC5-d72642e7-2e18-4cd8-be2f-05b8fe4ccd2b_9d07f7e3-268d-4a88-ad67-b552db7fed90.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Magnesium hydroxide,1309-42-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a8eb6cc-7c6c-4f6c-8965-1336ba13b9d7/documents/IUC5-d72642e7-2e18-4cd8-be2f-05b8fe4ccd2b_9d07f7e3-268d-4a88-ad67-b552db7fed90.html,,inhalation,LC50,> 2.1 mg/L,no adverse effect observed, Magnesium nitrate,10377-60-3," No reliable study with magnesium nitrate is available. Based on an expert statement, a sub-chroning repeated dose toxicity study does not need to be conducted. A reliable study with potassium nitrate is however available. This OECD 422 study did not show any effects up to the highest dose level tested (1500 mg/kg bw/day). The read-across rationale can be found in the document attached in the appropriate target record. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d5a31864-8a52-4053-8b22-84cf45706626/documents/IUC5-2649b706-eb73-4a94-b118-15ce91e0a82a_b6293107-2d43-44e1-acf3-9fc4cfcb3cc8.html,,,,,, Magnesium nitrate,10377-60-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d5a31864-8a52-4053-8b22-84cf45706626/documents/IUC5-2649b706-eb73-4a94-b118-15ce91e0a82a_b6293107-2d43-44e1-acf3-9fc4cfcb3cc8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,500 mg/kg bw/day",,rat Magnesium nitrate,10377-60-3," With magnesium nitrate (hexahydrate) the acute oral toxicity study with rats showed an LD50 >2000 mg/kg bw. No reliable acute dermal toxicity study with magnesium nitrate is present, however a dermal toxicity study in rats with potassium nitrate showed an LD50 >5000 mg/kg bw. An acute inhalation study is not required due to the low vapour pressure and the high particle size of magnesium nitrate (hexahydrate). The read-across rationale can be found in the document attached in the appropriate target record. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5a31864-8a52-4053-8b22-84cf45706626/documents/IUC5-04b28151-74b7-48f1-94f9-4d7ab2a6a615_b6293107-2d43-44e1-acf3-9fc4cfcb3cc8.html,,,,,, Magnesium nitrate,10377-60-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5a31864-8a52-4053-8b22-84cf45706626/documents/IUC5-04b28151-74b7-48f1-94f9-4d7ab2a6a615_b6293107-2d43-44e1-acf3-9fc4cfcb3cc8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Magnesium nitrate,10377-60-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5a31864-8a52-4053-8b22-84cf45706626/documents/IUC5-04b28151-74b7-48f1-94f9-4d7ab2a6a615_b6293107-2d43-44e1-acf3-9fc4cfcb3cc8.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Magnesium,7439-95-4,"Toxicity via the oral route is addressed by upper intake level (UL) for adults determined by the Scientific Committee on Food (SCF), being UL = 250 mg/d, corresponding to 3.6 mg/kg bw/d (70 kg person) for magnesium (the report of SCF is attached on this summary; see section 7.12).   Repeated dose toxicity: oral Short-term Soltani, 2005, 8 week rat RA (MgSO4) (Supporting) No effect levels derived The present results show that 10 g/L Mg administration in drinking water to diabetic rats causes a slight increase in its plasma levels that never reach control levels. The administration of Mg corrected hyperglycemia and has brought blood glucose back to normal levels within 24 h of its administration. Mg stabilised glucose levels over the course of treatment and seems to have some reparative effects on the pancreas of STZ-induced diabetic rats. 10 g/L MgSO4 had desired biochemical and histological effects. Lower doses had no effect and higher doses (30 g/L) decreased blood glucose, but its histological effect was deleterious. A very high concentration of 50g/L causes death.   Sub-chronic Takizawa (2000) 90-day rat RA (MgCl2.6H2O) (WoE) Under the conditions of this study, the dose of 0.5 % (i.e. 308 mg/kg bw/d for males and 299 mg/kg bw/d for females) was considered as the no-observed-adverse-effect-level (NOAEL).   Tanaka (1993) 90-day mouse RA (MgCl2.6H2O) (WoE) The present subchronic study demonstrated that only high levels (2.5 and 5%) of magnesium chloride hexahydrate exert any toxic effects and these are limited to effects on kidney weights and minimal renal tubular changes in male B6C3F1 mice. The NOEL for both sex was determined to be 1.25% magnesium chloride hexahydrate in diet which corresponds to 2.69 g/kg bw/d in males and 3.26 g/kg bw/d in females.   Sondergaard (1990) 90-day rat RA (Mg stearate) (WoE) The NOEL was established at 5% magnesium stearate in diet, which refers to 2500 mg/kg bw/day, based on effects on relative liver weights in males of the 10 and 20% groups. Increasd amounts of iron were found in the livers of animals fed 20%. In addition, male animals of the 20% group showed decreased body weight gain, and urolithiasis was found in male and female animals of this group.   Chronic Kurata (1989) 96 weeks mouse RA (MgCl2.6H2O) (Key) The NOEL was determined to be 0.5% magnesium chloride hexahydrate in diet, which refers to 730 mg/kg bw/day, based on decreased body weights in female animals.     Repeated dose toxicity: inhalation  Short-term Hori (1994) 4 weeks rat RA (MgSO4) (Supporting) Subacute inhaltion exposure of rats with the test material (short and long magnesium sulphate whiskers) did not affect growth curves, survival rates and organ weights in treated rats compared to control animals. There was no effect on the Mg contents in the lungs of different groups. Histopathology did not indicate significant differences between control and exposure groups.   Reichrtova & Takac (2005), 200 hours rat RA (MgO) (Supporting) Wistar rats were exposed by inhalation to a dust (particles smaler than 5µm) containing a high percentage of MgO (up to 1000 mg/m³). This dust was collected from environmental sample collection devices around Slovak magnesite factory. Several results were reported. Animals receiving repeated exposures totaling 200 hours showed a diminished ability to eliminate magnesium as compared to animals that received a single exposure. Repeated exposures caused increased levels of magnesium in the serum and urine, indicating that the inhaled dust was gradually dissolved in the body. The inhaled dust was eliminated by the lymphatic system as well, as evidenced by histological examination of the spleen, where particles were present in sinusoid macrophages. Even though significant amounts of magnesium were excreted, increased magnesium levels were observed in the liver, spleen, and lung 25 days after the last exposure. In the lung, dust particles were found in thickened interalveolar septa and macrophages, but no signs of pulmonary fibrosis were observed. The findings showed that MgO dust was eliminated by blood and lymph.”   Chronic  Hori (1994) 1 year rat RA (MgSO4) (Supporting) Chronic inhalation exposure of rats to the test material (long or short magnesium sulphate whiskers) did not reduce the survival rate. There were no differences in growth curves, organ weights or histopathological findings in lungs between treated and control animals.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53402491-7b6a-4d27-ba9a-be9115ea660b/documents/381cce57-9557-43e5-b9a3-03b5c91c6ebd_ec60e170-a441-43ee-9bef-baa3d4164eff.html,,,,,, Magnesium,7439-95-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53402491-7b6a-4d27-ba9a-be9115ea660b/documents/381cce57-9557-43e5-b9a3-03b5c91c6ebd_ec60e170-a441-43ee-9bef-baa3d4164eff.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,3.6 mg/kg bw/day,, Magnesium,7439-95-4,"Magnesium is not acutely toxic via the oral, dermal, or inhalation route ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53402491-7b6a-4d27-ba9a-be9115ea660b/documents/42c198cd-49db-4099-97ed-898b4ea7ffd2_ec60e170-a441-43ee-9bef-baa3d4164eff.html,,,,,, Magnesium,7439-95-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53402491-7b6a-4d27-ba9a-be9115ea660b/documents/42c198cd-49db-4099-97ed-898b4ea7ffd2_ec60e170-a441-43ee-9bef-baa3d4164eff.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Magnesium sulphate,7487-88-9,"No reliable studies with magnesium sulphate are available. A subacute oral toxicity study in rats with potassium sulphate shows no toxicity up to the highest dose tested (1500 mg/kg bw/day). In a chronic study with ammonium sulphate absolute and relative kidney weights were increased at the high dose level for both sexes, absolute spleen weights were decreased and relative liver weights were increased in high dose males. Based on these reliable studies with potassium sulphate and ammonium sulphate for oral repeated dose toxicity, the rat oral NOAEL for the sulphate category is 1500 mg/kg bw/day for subacute toxicity. For chronic toxicity the NOAEL for the sulphate category is 256 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37b4335e-64ed-474c-a45d-2d04d3cb7e7d/documents/IUC5-07d57649-919c-4d6f-8d53-8f7f4e31f95a_29bd9e40-92fa-464d-b3dd-f61129608469.html,,,,,, Magnesium sulphate,7487-88-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37b4335e-64ed-474c-a45d-2d04d3cb7e7d/documents/IUC5-07d57649-919c-4d6f-8d53-8f7f4e31f95a_29bd9e40-92fa-464d-b3dd-f61129608469.html,Chronic toxicity – systemic effects,oral,NOAEL,256 mg/kg bw/day,,rat Magnesium sulphate,7487-88-9,"No reliable study with magnesium sulphate is present. With potassium sulphate a reliable acute dermal toxicity study in rats (according to OECD 402) has been performed showing an LD50 > 2000 mg/kg bw. Reliable acute oral toxicity studies with rats according to OECD 425, one with potassium magnesium sulphate and another one with ammonium phosphate sulphate have been performed, and both showed LD50s>2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37b4335e-64ed-474c-a45d-2d04d3cb7e7d/documents/IUC5-bdf82e6a-2fa9-4fa9-8d8a-fae65cb69c89_29bd9e40-92fa-464d-b3dd-f61129608469.html,,,,,, Magnesium sulphate,7487-88-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37b4335e-64ed-474c-a45d-2d04d3cb7e7d/documents/IUC5-bdf82e6a-2fa9-4fa9-8d8a-fae65cb69c89_29bd9e40-92fa-464d-b3dd-f61129608469.html,,oral,LD50,"2,000 mg/kg bw",, Magnesium sulphate,7487-88-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37b4335e-64ed-474c-a45d-2d04d3cb7e7d/documents/IUC5-bdf82e6a-2fa9-4fa9-8d8a-fae65cb69c89_29bd9e40-92fa-464d-b3dd-f61129608469.html,,dermal,LD50,"2,000 mg/kg bw",, [carbonato(2-)]hexadecahydroxybis(aluminium)hexamagnesium,11097-59-9,"Read-across from analogue substances was applied.Key values for risk assessment: 28-d NOAEL 1000 mg/kg bw/d (read-across from substance with EC no. 423-570-6)chronic NOAEL: 605 mg/kg bw/d (in analogy to RIVM decision for Alcamizer P93, dated 23 October 2007, BMS071023.03) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54d9d491-0d62-4769-90fd-b17bdacdcc27/documents/IUC5-7acf3811-7ef5-41f3-9f36-e042279ccac5_d0bbd640-877b-4ffe-8a99-dd4d4fd51ba3.html,,,,,, [carbonato(2-)]hexadecahydroxybis(aluminium)hexamagnesium,11097-59-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54d9d491-0d62-4769-90fd-b17bdacdcc27/documents/IUC5-7acf3811-7ef5-41f3-9f36-e042279ccac5_d0bbd640-877b-4ffe-8a99-dd4d4fd51ba3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat [carbonato(2-)]hexadecahydroxybis(aluminium)hexamagnesium,11097-59-9,"Read across from Alcamizer 5 (422-150-1) and Aluminium-magnesium-zinc-carbonate-hydroxide (EC 423-570-6).Alcamizer 5: Acute oral study (EEC-Directive 92/69 B.1, according to GLP principles): Alcamizer 5 has been tested in a gavage study. The LD50 was established to be > 2000 mg/kg.Acute inhalation study (OECD 403 according to GLP principles): The LC50 was established to be > 5.16 mg/l (4 h exposure). Dermal acute toxicity (EEC-Directive 92/69 B.3, according to GLP principles): Alcamizer5 has been tested in a 24-hours, semi-occlusive study exposing 5 males and 4 females Wistar Crl: (WI)BR rat to 2000 mg/kg bw. No mortality occurred and no clinical signs were observed. The LD50 was established to be > 2000 mg/kg bw. Aluminium-magnesium-zinc-carbonate-hydroxide:Acute oral study (EEC-Directive 92/69 B.1, according to GLP principles): Aluminium-magnesium-zinc-carbonate-hydroxide-(hydrate) has been tested in a gavage study exposing 5 males and 5 females wistar rat to 2000 mg/kg bw. No mortality occurred and no clinical signs were observed. The LD50 was established to be > 2000 mg/kg bw.Acute inhalation study (OECD 403 according to GLP principles):Aluminium-magnesium-zinc-carbonate-hydroxide-(hydrate) has been tested in a nose only study exposing for 4-hours 5 males and 5 females wistar rat to a concentration of 5.17 mg/l. No mortality occurred. Slight visually decreased breathing rate in all animals during the first two hours, aggravating to moderate decreased breathing rate in the last two hours. Findings at necropsy were limited to discouraging of the lungs seen in three animals. The LC50 was established to be > 5.17 mg/l.Supporting study:single dose toxicity study: [carbonato(2-)]hexadecahydroxybis(aluminium)hexamagnesium caused no mortality when administered orally, subcutaneously or intraperitoneally, to male mice up to a dose level of 10 gram/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54d9d491-0d62-4769-90fd-b17bdacdcc27/documents/IUC5-93faa4e8-3baf-4b97-8ede-6e9e61ddd7b0_d0bbd640-877b-4ffe-8a99-dd4d4fd51ba3.html,,,,,, [carbonato(2-)]hexadecahydroxybis(aluminium)hexamagnesium,11097-59-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54d9d491-0d62-4769-90fd-b17bdacdcc27/documents/IUC5-93faa4e8-3baf-4b97-8ede-6e9e61ddd7b0_d0bbd640-877b-4ffe-8a99-dd4d4fd51ba3.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, [carbonato(2-)]hexadecahydroxybis(aluminium)hexamagnesium,11097-59-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54d9d491-0d62-4769-90fd-b17bdacdcc27/documents/IUC5-93faa4e8-3baf-4b97-8ede-6e9e61ddd7b0_d0bbd640-877b-4ffe-8a99-dd4d4fd51ba3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, [carbonato(2-)]hexadecahydroxybis(aluminium)hexamagnesium,11097-59-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54d9d491-0d62-4769-90fd-b17bdacdcc27/documents/IUC5-93faa4e8-3baf-4b97-8ede-6e9e61ddd7b0_d0bbd640-877b-4ffe-8a99-dd4d4fd51ba3.html,,inhalation,LC50,5.16 mg/m3,no adverse effect observed, Maleic acid,110-16-7,"There are two subchronic toxicity studies with maleic anhydride available. In a subchronic toxicity study performed euqivalent to OECD 408, maleic anhydride (purity 99.5%) was administered to 15 Sprague-Dawley rats/sex/dose in diet at dose levels of 0, 20, 40, 100, 250 or 600 mg/kg bw/day. The LOAEL in males is considered to be 100 mg/kg bw/day and the NOAEL in males is 40 mg/kg bw/d. The LOAEL in females is considered to be 250 mg/kg bw/day and the NOAEL in females is 100 mg/kg bw/d., based on renal changes. In a second subchronic toxicity study (similar to OECD Guideline 409), maleic anhydride (purity >99.5%) in peanut oil was administered to 4 Beagle dogs/sex/dose in diet at dose levels of 0, 20, 40 or 60 mg/kg bw/day. Here, the NOAEL is 60 mg/kg bw/day. In addition, there is one chronic toxicity study with maleic acid and two chronic toxicity studies with maleic anhydride.  In the chronic toxicity study with maleic acid 12 male Osborne-Mendel rats/dose were exposed via diet at dose levels of 0, 5000, 10000 and 15000 ppm for two years. The LOAEL is 5000 ppm maleic acid. The NOAEL cannot be identified. In a chronic toxicity study (performed equivalent to OECD 452), maleic anhydride was administered to 126 rats Fischer 344/sex/dose in diet at dose levels of 0, 10, 32 or 100 mg/kg bw/day for 2 years. The NOEL is 10 mg/kg bw/day. The LOEL is 32 mg/kg bw/day, based on small but dose related reduced body weights. In a chronic toxicity study (performed equivalent to OECD 452), maleic anhydride was administered to 50 male Sprague-Dawley rats/dose in diet at dose levels of 0, 250 and 600 mg/kg bw/day for 183 days. The LOAEL is 250 mg/kg bw/d based on increased organ weight (liver, kidnery, heart, brain, testes) and histopathological changes.  ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8031ae7-e5e1-4f10-8093-e4a587834874/documents/IUC5-f41df2e9-daf2-4fae-97c5-ef05fe592036_63bae70e-5dba-43fc-9176-d8cb7f83bee5.html,,,,,, Maleic acid,110-16-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8031ae7-e5e1-4f10-8093-e4a587834874/documents/IUC5-f41df2e9-daf2-4fae-97c5-ef05fe592036_63bae70e-5dba-43fc-9176-d8cb7f83bee5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat Maleic acid,110-16-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8031ae7-e5e1-4f10-8093-e4a587834874/documents/IUC5-f41df2e9-daf2-4fae-97c5-ef05fe592036_63bae70e-5dba-43fc-9176-d8cb7f83bee5.html,Chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Maleic acid,110-16-7,"Acute oral toxicity: There are currently two studies conducted with maleic acid. The LD50 with maleic acid is 708 mg/kg bw (no data on guideline followed) and 2870 mg/kg bw (OECD 401). Based on the first study, classification as acute tox 4 is warranted. In addition, there are two studies with maleic anhydride. Both studies are performed equivalent to OECD 401. The LD50 is 1030 and 1090 mg/kd bw. Acute dermal toxicity: There is data on one acute dermal toxicity study performed with maleic acid and two studies with maleic anhydride. LD50 for maleic acid is 1560 mg/kg bw (no data on guideline followed), whereas the LD50 for maleic anhydride are greater than 398-631 mg/kg bw (no guideline followed) and 2620 mg/kg bw (performed equivalent to OECD 402).  Acute toxicity, inhalation: Inhalation is no relevant route of exposure, as the size particles are to large to inhale. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8031ae7-e5e1-4f10-8093-e4a587834874/documents/IUC5-9561cde2-45af-444b-8c32-58581b1eb850_63bae70e-5dba-43fc-9176-d8cb7f83bee5.html,,,,,, Maleic acid,110-16-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8031ae7-e5e1-4f10-8093-e4a587834874/documents/IUC5-9561cde2-45af-444b-8c32-58581b1eb850_63bae70e-5dba-43fc-9176-d8cb7f83bee5.html,,oral,LD50,708 mg/kg bw,adverse effect observed, Maleic acid,110-16-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8031ae7-e5e1-4f10-8093-e4a587834874/documents/IUC5-9561cde2-45af-444b-8c32-58581b1eb850_63bae70e-5dba-43fc-9176-d8cb7f83bee5.html,,dermal,LD50,"1,560 mg/kg bw",adverse effect observed, Maleic anhydride,108-31-6," Suitable data were available to assess the toxicity of maleic anhydride after repeated dose exposure. Therefore, the available data from repeated dose toxicity studies conducted with maleic anhydride were used in a weight of evidence approach to assess the specific target organ toxicity of the target substance. Based on the results and in accordance with ATP13 to CLP Regulation 1272/2008 classification as STOT RE 1, H372 is warranted. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4bf3dfbe-ef6b-4087-99c6-4e377d0fdfcd/documents/IUC5-7fca3cc9-1c9f-4bf5-bc76-019df5b0c9c7_6fb3c003-81c0-4b2d-a650-5af844b2ea9d.html,,,,,, Maleic anhydride,108-31-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4bf3dfbe-ef6b-4087-99c6-4e377d0fdfcd/documents/IUC5-7fca3cc9-1c9f-4bf5-bc76-019df5b0c9c7_6fb3c003-81c0-4b2d-a650-5af844b2ea9d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,dog Maleic anhydride,108-31-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4bf3dfbe-ef6b-4087-99c6-4e377d0fdfcd/documents/IUC5-7fca3cc9-1c9f-4bf5-bc76-019df5b0c9c7_6fb3c003-81c0-4b2d-a650-5af844b2ea9d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,3.3 mg/m3,,rat Maleic anhydride,108-31-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4bf3dfbe-ef6b-4087-99c6-4e377d0fdfcd/documents/IUC5-7fca3cc9-1c9f-4bf5-bc76-019df5b0c9c7_6fb3c003-81c0-4b2d-a650-5af844b2ea9d.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1.1 mg/m3,adverse effect observed,rat Maleic anhydride,108-31-6," Data are available to assess the acute oral, inhalation and dermal toxicity of the target substance maleic anhydride. In an acute oral toxicity study conducted according to OECD 401, Wistar rats (5/sex) were orally exposed to 1.0, 1.125, 1.25 and 1.99 g/kg bw test item. Based on the results, the oral LD50 can be considered to be 1090 mg/kg bw. In a multispecies acute inhalation study one cat, one rabbit, one guinea pig, four rats and ten mice were exposed via inhalation to 4.35 mg/L air of maleic anhydride (static, presumably aerosolised atmosphere) for 1 hour. Based on the results the LC50 values in rats and mice were determined to be higher than 4.35 mg/L. However, under the conditions of this experiment, the study cannot be used for classification. Since the target substance is harmonised classified Skin Corr.1B, a waiver argument was used to cover this endpoint. In an acute dermal toxicity study groups of female albino New Zealand rabbits were dermally exposed to maleic anhydide (1930 - 3550 mg/kg bw) for 24 hours. The reported dermal LD50 in female rabbits was 2620 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4bf3dfbe-ef6b-4087-99c6-4e377d0fdfcd/documents/IUC5-93b2f6b1-0822-45b9-a4f0-6e6fd0de7ab3_6fb3c003-81c0-4b2d-a650-5af844b2ea9d.html,,,,,, Maleic anhydride,108-31-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4bf3dfbe-ef6b-4087-99c6-4e377d0fdfcd/documents/IUC5-93b2f6b1-0822-45b9-a4f0-6e6fd0de7ab3_6fb3c003-81c0-4b2d-a650-5af844b2ea9d.html,,oral,LD50,"1,090 mg/kg bw",adverse effect observed, Maleic anhydride,108-31-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4bf3dfbe-ef6b-4087-99c6-4e377d0fdfcd/documents/IUC5-93b2f6b1-0822-45b9-a4f0-6e6fd0de7ab3_6fb3c003-81c0-4b2d-a650-5af844b2ea9d.html,,dermal,LD50,"2,620 mg/kg bw",adverse effect observed, Malonic acid,141-82-2," In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test [OECD TG 422], Crj: CD (SD) IGS rats were given disodium succinate hexahydrate by gavage at 0, 100, 300, or 1,000 mg/kg bw/day. Males were dosed for 52 days from day 14 before mating and females were dosed from day 14 before mating to day 4 of lactation throughout the mating and pregnancy period. Blood urea nitrogen levels were increased in females at 1,000 mg/kg bw/day. Higher levels of urinary protein were found in one and two of the five males at 300 and 1,000 mg/kg bw/day, respectively, whereas no animals with these high levels were found in the control and 100 mg/kg bw/day groups. These findings suggest adverse effects of this compound on the kidney. Therefore, the NOAEL of disodium succinate hexahydrate for repeated dose toxicity was considered to be 100 mg (equivalent to 60 mg of disodium succinate)/kg bw/day for male rats and 300 mg (equivalent to 180 mg of disodium succinate)/kg bw/day for female rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cea8900a-d600-40cf-b784-2da1ec1cb631/documents/a436bf97-bdeb-4b6c-8e0d-bb177f6a640f_33286727-5104-46b0-9018-eebcaa3422ce.html,,,,,, Malonic acid,141-82-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cea8900a-d600-40cf-b784-2da1ec1cb631/documents/a436bf97-bdeb-4b6c-8e0d-bb177f6a640f_33286727-5104-46b0-9018-eebcaa3422ce.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat Malonic acid,141-82-2," In an oral acute toxicity study, the LD50 for malonic acid in male albino rats was 3250 mg/kg bw and for female albino rats 2750 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cea8900a-d600-40cf-b784-2da1ec1cb631/documents/7e89d7ef-e0ec-475f-b648-492555729b46_33286727-5104-46b0-9018-eebcaa3422ce.html,,,,,, Malonic acid,141-82-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cea8900a-d600-40cf-b784-2da1ec1cb631/documents/7e89d7ef-e0ec-475f-b648-492555729b46_33286727-5104-46b0-9018-eebcaa3422ce.html,,oral,LD50,"2,750 mg/kg bw",adverse effect observed, 4-O-α-D-glucopyranosyl-D-glucitol,585-88-6," Acute oral toxicity: Read-across from Syrups, corn, hydrogenated (CAS 68425-17-2/ EC 270-337-8): LD50 rat and mouse > 24.37 g/kg bw (Reliability 2 key studies; Non GLP; OECD 423 test guideline) (Research Laboratories of Roquette Freres, 1982). Based on the analogy approach applied together with the supporting peer reviewed data on Maltitol (LD50 mouse > 25.3 mL/kg bw; CIR, 2008), the target substance Maltitol is not considered to be hazardous for acute oral toxicity according to CLP. Acute dermal toxicity: no data required according to REACh (Regulation (EC) No 1907/2006), Annex VII Acute inhalation toxicity: no data required according to REACh (Regulation (EC) No 1907/2006), Annex VII ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0423f6c5-aa0e-47b9-8b6c-91b5a83f4625/documents/9a70d93b-a5ab-47b8-8a5f-7bbafedc2d7b_12e3a378-7329-4cdd-a545-ec4add1f51e6.html,,,,,, 4-O-α-D-glucopyranosyl-D-glucitol,585-88-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0423f6c5-aa0e-47b9-8b6c-91b5a83f4625/documents/9a70d93b-a5ab-47b8-8a5f-7bbafedc2d7b_12e3a378-7329-4cdd-a545-ec4add1f51e6.html,,oral,LD50,"24,370 mg/kg bw",no adverse effect observed, 3-hydroxy-2-methyl-4-pyrone,118-71-8, Read-across to Ethyl Maltol (CAS No. 4940-11-8) - Subchronic NOAEL (rat): 500 mg/kg bw/day (Equivalent or similar to OECD 408) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10cc7ca3-e795-4499-ab8c-3294bdcf36bf/documents/44fab3c8-b346-4b04-a330-03c57ff42d8d_78ef597f-a1c3-4459-a277-1766cd2cb61b.html,,,,,, 3-hydroxy-2-methyl-4-pyrone,118-71-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10cc7ca3-e795-4499-ab8c-3294bdcf36bf/documents/44fab3c8-b346-4b04-a330-03c57ff42d8d_78ef597f-a1c3-4459-a277-1766cd2cb61b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat 3-hydroxy-2-methyl-4-pyrone,118-71-8, Acute oral toxicity: LD50 (male) = 1440 mg/kg bw with 95% CI 1274-1627 mg/kg bw (Equivalent or similar to OECD 401) Acute dermal toxicity: LD50 (female) = >2000 mg/kg bw (OECD 402/GLP) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10cc7ca3-e795-4499-ab8c-3294bdcf36bf/documents/506d1227-4584-4a25-a3f0-0152ada23c2d_78ef597f-a1c3-4459-a277-1766cd2cb61b.html,,,,,, 3-hydroxy-2-methyl-4-pyrone,118-71-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10cc7ca3-e795-4499-ab8c-3294bdcf36bf/documents/506d1227-4584-4a25-a3f0-0152ada23c2d_78ef597f-a1c3-4459-a277-1766cd2cb61b.html,,oral,LD50,"1,440 mg/kg bw",adverse effect observed, 3-hydroxy-2-methyl-4-pyrone,118-71-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10cc7ca3-e795-4499-ab8c-3294bdcf36bf/documents/506d1227-4584-4a25-a3f0-0152ada23c2d_78ef597f-a1c3-4459-a277-1766cd2cb61b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Mandelic acid,90-64-2, Compilation of available data was provided in a WoE approach. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71d849af-b8c7-4f40-95d0-60bb50b876f3/documents/5d29fb29-92c3-435e-9841-b9d9f4858c88_a70b6905-c5f2-479b-abf7-610baa0b1f70.html,,,,,, Mandelic acid,90-64-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71d849af-b8c7-4f40-95d0-60bb50b876f3/documents/5d29fb29-92c3-435e-9841-b9d9f4858c88_a70b6905-c5f2-479b-abf7-610baa0b1f70.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Manganese dichloride,7773-01-5," Please refer to the RAAF report attached to section 13 of this dataset which discusses the cateogory approach for sharing of data between the three soluble manganese salts Mn chloride, Mn nitrate and Mn sulphate. There is a body of publicly available literature data on repeated application of MnCl2 however, these data are not conducted according to standardised test guidelines or the principles of GLP and are of varying quality and reliability.  Whilst the literature for repeated dose toxicity of MnCl2 shows a variety of effects on repeated application of MnCl2, these studies are not consistent in their dosing methods, duration, or with the species of test animals that are used.  As a consequence of this, the results are variable and not aligned with observations from more reliable studies conducted to standardised international guidelines and GLP.  Therefore the effects observed in the reproductive and developmental toxicity studies on MnCl2 via the inhalation route are given more weight than the lower reliability literature references and are considered to be the better indicator of the long term toxicological effects of this substance via the inhalation route rather than the older literature data. In the reproductive toxicity study by Grieve (2017) subsequently published by McGough & Jardine (2016) clinical signs of reaction to treatment to inhalation exposure of MnCl2 were confined to a few animals with wheezing respiration in the F0 generation exposed to 10 and 20 μg/L.  At 20 μg/L, overall body weights and food consumption of the F0 males throughout the study were lower than controls.  At target 10 and 20 μg/L, there was a statistically significant increase in kidney weights compared to the controls, however there was no alteration in the normal structure of these organs.  In all treated F0 females, there was a statistically significant increase in lung weights compared to the controls which was not evident in the F1 females.  The NOEL for adult effects was not established due to effects on the respiratory tract.  However, the respiratory tract effects observed are commonly observed in irritant materials and were considered not to be a unique effect of MnCl2 and therefore, when the local irritant effects are disregarded, the parental NOAEL was considered to be 20 μg/L (Grieve, 2017). In the developmental toxicity study (Dettwiler, 2015) conducted in accordance with OECD Guideline 414, treatment with MnCl2 caused breathing noises in eight females in exposed to 15 μg/L air and eighteen females exposed to 25 μg/L air.  Treatment caused a dose dependent reduction in food consumption in groups exposed to 15 μg/L air and 25 μg/L air. This reduction was statistically significant during the most of the study and was accompanied by reduced body weights, reduced body weight gain during the study and reduced corrected body weight gain at termination at both dose levels and therefore effect on food consumption was considered to be adverse.  Histopathology examination performed on the lungs from six selected pregnant females per group revealed lesions with a dose dependent frequency and severity in groups exposed to 15 μg/L and 25 μg/L.  The macroscopically identified foci in two females in groups exposed to 25 μg/L were correlated to alveolar haemorrhage or phagocytic alveolar macrophage foci. Based on these results, the NOAEL as well as the NOEL for the toxicity in pregnant females were considered to be 5 μg/L air.  In non-pregnant females, the NOEL for systemic toxicity was established at 15 μg/L air, whereas the NOAEL was established at 25 μg/L air.  These observations are consistent with a number of literature references indicating a loss of body weight during administration of MnCl2 and a developmental neurotoxicity study which also noted this loss and a dose-dependent reduction in food consumption (Dettwiler, 2016). The repeated dose studies on MnSO4 were from the US National Toxicology Program technical report on the toxicology and carcinogenesis of manganese(II) sulphate monohydrate in F344/N rats and B6C3F1 mice (feed studies) (NTP, 1993).  The studies were not conducted to then-standardised guidelines but to peer reviewed methods as specified by the NTP and as such are considered wholly reliable. The high level of MnSO4 consumed by rats on a daily basis for 13 weeks in this study, without mortality, supports the lack of acute toxicity.  In the two-year study survival of male rats exposed to 15 000 ppm was significantly lower than that of the controls attributed to increased incidences of advanced renal disease relating to the ingestion of MnSO4. The final mean bodyweight of male rats exposed to 15 000 ppm was 10 % lower than that of the controls. The mean body weights of all the other exposed groups were similar to the controls (NTP, 1993).  At both the 9- and 15-month interim evaluations, tissue concentrations of manganese were significantly elevated in the livers of male and female rats exposed to 5 000 and 15 000 ppm, with an accompanying depression of hepatic iron.  The ingestion of diets containing 15 000 ppm MnSO4 was associated with a marginal increase in the average severity of nephropathy in male rats. In these rats, lesions associated with renal failure, uraemia, and secondary hyperparathyroidism were observed.  No increased incidence of neoplasms in male or female rats was attributed to ingestion of MnSO4.  There was no evidence of carcinogenic activity of manganese sulphate monohydrate in male or female F344/N rats (NTP, 1993). In mice, no clinical findings were attributed to manganese sulphate ingestion at 13 weeks (NTP, 1993).  Concentrations of manganese were significantly elevated in the livers of mice exposed to 5 000 and 15 000 ppm at the 9 and 15 month evaluations. It was uncertain if the slightly increased incidence of follicular cell adenoma is related to the ingestion of MnSO4. The study suggests equivocal evidence of carcinogenicity in male and female mice. Based on marginally increased incidences of thyroid gland follicular cell adenoma and significantly increased incidences of follicular cell hyperplasia (NTP, 1993). There are no data available on manganese dinitrate itself. As stated above, given that the toxicity of the soluble manganese salts is generally accepted to be attributed to the Mn2+ ion it is proposed to use read across to maximise the use of the available data. The lack of GLP, guideline studies performed on MnCl2 to specifically investigate the repeated dose effects warrants the application of the information generated in the reproductive and developmental  toxicity studies on this substance.  These studies are conducted under GLP conditions to modern standardised guidelines and are considered to provide adequate information with regards to the long term effects of the substance via the inhalation route.  Similarly it is considered appropriate to use these same studies as the source of data to address the repeated dose toxicity of MnSO4 via the  inhalation route as no data are available on the toxicity of the sulphate via this route  of exposure. The repeated dose toxicity studies conducted on MnSO4 in support of the NTP programme are well conducted and reliable studies and are considered to be the most appropriate source of data on the long term effects of exposure to the Mn2+ ion via the oral route.  As such it is considered appropriate to use these studies to support this endpoint in both the MnSO4 dossier and as read across in the MnCl2 dossier.  These studies on MnSO4 via the oral route do not result in the classification of the substance and in conjunction with studies via the inhalation route conducted on MnCL2 are considered to represent the “worst case scenario” in relation to the effects of long term exposure to soluble manganese salts. No repeated dose toxicity studies are available on Mn(NO3)2 manganese dinitrate  and read-across is proposed for these endpoints. As described above, given that the toxicity of the soluble manganese salts is generally accepted to be attributed to the Mn2+ ion in conjunction with the lack of any modern studies performed on Mn(NO3)2 , it is considered appropriate to utilise read-across to the key studies performed on MnCl2 (inhalation exposure) and MnSO4 ( Oral exposure). Furthermore, it is considered that these guideline studies can be considered to give an accurate representation of the toxicity of the Mn2+ ion in Mn(NO3)2 and should therefore be considered adequate to address these endpoints. These studies via the oral route (MnSO4) do not result in the classification of the substance and as such the studies via the inhalation route as conducted on MnCL2 are considered to represent the “worst case scenario” in relation to the effects of long term exposure to soluble manganese salts. Read-across between the three salts is considered to be justified based on the high water solubility and ultimate identical physiological fate all three salts share once the anions disassociate into the respective endogenous physiological pools.  In the case of both MnCl2 and MnSO4, evidence suggests that repeated dosing triggers a strong homeostatic response which reduces the toxicity by presumably increasing excretion/decreasing absorption (Vrcic and Kello, 1988).  This can be taken as further evidence that read-across between these three soluble manganese salts  is justified. Toxicokinetic and toxicity data confirm  that the manganese cations are the driving factor for any human health effects observed.  The respective anions, chloride (Cl-), sulphate (SO42-) and nitrate (NO3 ), are readily absorbed and excreted from the human body, and their contribution on toxicological effects is not considered significant. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03f7b1f3-33bc-4c11-985a-fa18c55db767/documents/IUC5-4218bec5-6b52-4c6c-8e3c-f8755f1ae2b7_8b629640-6b75-48b0-a660-435ce10ac983.html,,,,,, Manganese dichloride,7773-01-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03f7b1f3-33bc-4c11-985a-fa18c55db767/documents/IUC5-4218bec5-6b52-4c6c-8e3c-f8755f1ae2b7_8b629640-6b75-48b0-a660-435ce10ac983.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,553 mg/kg bw/day,,rat Manganese dichloride,7773-01-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03f7b1f3-33bc-4c11-985a-fa18c55db767/documents/IUC5-4218bec5-6b52-4c6c-8e3c-f8755f1ae2b7_8b629640-6b75-48b0-a660-435ce10ac983.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.3 mg/m3,,monkey Manganese dichloride,7773-01-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03f7b1f3-33bc-4c11-985a-fa18c55db767/documents/IUC5-4218bec5-6b52-4c6c-8e3c-f8755f1ae2b7_8b629640-6b75-48b0-a660-435ce10ac983.html,Repeated dose toxicity – local effects,inhalation,NOAEC,3.9 mg/m3,no adverse effect observed,rabbit Manganese dichloride,7773-01-5," Extensive acute oral data is available on the manganese dichloride, allowing selection of an oral LD50 on which to base classification. Inhalation LC50 data is available for a surrogate material (manganese sulphate), and an estimate of the classification is made for the dermal route using dermal and oral absorption, and acute oral toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03f7b1f3-33bc-4c11-985a-fa18c55db767/documents/IUC5-a1c20b74-08ea-43a7-bb3d-6a2b2b3e883d_8b629640-6b75-48b0-a660-435ce10ac983.html,,,,,, Manganese dichloride,7773-01-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03f7b1f3-33bc-4c11-985a-fa18c55db767/documents/IUC5-a1c20b74-08ea-43a7-bb3d-6a2b2b3e883d_8b629640-6b75-48b0-a660-435ce10ac983.html,,oral,LD50,236 mg/kg bw,adverse effect observed, Manganese dichloride,7773-01-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03f7b1f3-33bc-4c11-985a-fa18c55db767/documents/IUC5-a1c20b74-08ea-43a7-bb3d-6a2b2b3e883d_8b629640-6b75-48b0-a660-435ce10ac983.html,,inhalation,LC50,4.45 mg/m3,no adverse effect observed, Manganese dioxide,1313-13-9,"REPEATED DOSE ORAL TOXICITY Supporting Study on Read Across Substance MnSO4 (NTP, 1993) Under the conditions of the study the NOAEL was 1 700 mg/kg bw for males and 2 000 mg/kg bw for females.   Supporting Study on Target Substance (Komura & Sakamoto (1991) Under the conditions of the study no NOAEL was identified.   REPEATED DOSE INHALATION TOXICITY Supporting Study on Read Across Substance MnCl2 (Grieve, 2017) Under the conditions of this study, the No Observed Effect Level was considered to be the target dose level 20 μg/L.   Supporting Study on Read Across Substance MnCl2 (Camner, 1985) Under the conditions of the study, no abnormalities were found in Mn(II) exposed animals, except for an increase in the size of alveolar macrophages in the high-dose group.   Supporting Study on Read Across Substance MnSO4 (Dorman, 2006) MnSO4 inhalation affected the haematology and resulted in increased Mn concentrations in the brain of the monkey.   Supporting Study on Target Substance (Rylander, 1971) In the animals exposed to MnO2, no significant changes in their particulate or bacterial clearance capacity as compared to the controls were observed.   Supporting Study on Target Substance (Rylander, 1973) Exposure to MnO2 caused a slight increase in the number of macrophages in the infection-controlled group. The number of leukocytes was increased in both types of guinea pig.   Supporting Study on Target Substance (Singh, 1977)  Histologically the lungs of most of the animals in the experimental group revealed normal structure of the pulmonary tissue with negligible amount of dust discernible. In some animals, small deposits of dusts persisted and cellular nodules composed of mononuclear cells, predominantly macrophages and thin reticulin fibres developed. The control animals did not reveal any comparable histologic change.   Supporting Study on Target Substance (Sylvestre, 1984) Under the conditions of the study, all exposed groups suffered emphysema-like tissue lesions, most severe in mice dosed with gas mixture plus MnO2.   MnO2 will be proposed for classification as STOT RE2 (H373)- target organ brain, on the basis of the Roels et al. (1992) study on battery workers - exposure is mainly to MnO2. The route of exposure in the study was inhalation and the sub-clinical effects seen at the exposure concentrations in the study, are believed to indicate that significant toxicity could occur at moderate exposure levels. On the basis of this proposal, it is considered that conducting animal testing would be both scientifically unjustified and unethical.  Therefore, in accordance with Annex XI, section 1.1 further sub-acute, sub-chronic and chronic toxicity tests are not considered necessary.   REPEATED DOSE DERMAL TOXICITY Short-term, sub-chronic and chronic toxicity studies via the dermal route do not need to be conducted as the physiological properties of the substance do not suggest a significant rate of absorption through the skin and no systemic effects or other evidence of absorption were seen in the skin or eye irritation studies (IUCLID section 7.3) and furthermore the water solubility of the substance is very poor (IUCLID section 4.8), and therefore a limited amount of potential substance is available for systemic absorption via the dermal route. Therefore, in accordance with Annex XI, section 1.1, testing via the inhalation route is not considered necessary. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6067752-51d7-4136-9b84-b8e2d9a4e430/documents/IUC5-6e34e0b4-2de5-4851-b9cc-334579c0bdee_6f0e698d-9b3b-4829-b0d9-de740ef2a5ae.html,,,,,, Manganese dioxide,1313-13-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6067752-51d7-4136-9b84-b8e2d9a4e430/documents/IUC5-6e34e0b4-2de5-4851-b9cc-334579c0bdee_6f0e698d-9b3b-4829-b0d9-de740ef2a5ae.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,700 mg/kg bw/day",,rat Manganese dioxide,1313-13-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6067752-51d7-4136-9b84-b8e2d9a4e430/documents/IUC5-6e34e0b4-2de5-4851-b9cc-334579c0bdee_6f0e698d-9b3b-4829-b0d9-de740ef2a5ae.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,3.9 mg/m3,,rabbit Manganese dioxide,1313-13-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6067752-51d7-4136-9b84-b8e2d9a4e430/documents/IUC5-6e34e0b4-2de5-4851-b9cc-334579c0bdee_6f0e698d-9b3b-4829-b0d9-de740ef2a5ae.html,Repeated dose toxicity – local effects,inhalation,LOAEC,3.9 mg/m3,adverse effect observed, Manganese dioxide,1313-13-9," Oral In accordance with Section 1 of REACH Annex XI, testing does not appear to be scientifically necessary; manganese dioxide is included in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) and is classified as acutely harmful by the oral route although there is no study available to justify this level of toxicity. Therefore, no further testing is proposed on animal welfare grounds and this classification is carried forward for risk assessment purposes.   Inhalation In accordance with Section 1 of REACH Annex XI, testing does not appear to be scientifically necessary; manganese dioxide is included in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) and is classified as acutely harmful by the inhalation route although there is no study available to justify this level of toxicity. Therefore, no further testing is proposed on animal welfare grounds and this classification is carried forward for risk assessment purposes.   Dermal In accordance with Column 2 of REACH Annex VIII, acute toxicity testing by the dermal route is not appropriate as the physicochemical and toxicological properties do not suggest potential for a significant rate of absorption through the skin. The substance is practically insoluble in water and inorganic ions do not pass easily through the dermal barrier. In particular the high charge on the Mn4+cation would have great difficulty in penetrating the skin. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6067752-51d7-4136-9b84-b8e2d9a4e430/documents/IUC5-9ce92972-6ded-4470-986e-bff76793cb7c_6f0e698d-9b3b-4829-b0d9-de740ef2a5ae.html,,,,,, Manganese sulphate,7785-87-7,"Key study data - US National Toxicology Program technical report on the toxicology and carcinogenesis of manganese(II) sulphate monohydrate in F344/N rats and B6C3F1 mice (feed studies) (NTP, 1993)   The National Toxicology Program (NTP) conducted a study which can be regarded a fully reliable guideline compliant GLP study on chronic toxicity.During the chronic study with rats , groups of 70 male and 70 female rats were fed diets containing 0, 1500, 5000, or 15000 ppm manganese (II) sulphate monohydrate for 103 weeks. Under the conditions of the study, the mean body weight of 15,000 ppm male rats was consistently lower than that of the control group throughout the 2-year study, and the final mean body weight was 10% lower. Survival of 15,000 ppm male rats in the 2-year study was also significantly lower than that of the control group. The reduced survival of 15,000 ppm males resulted from the increased incidences of marked nephropathy and renal failure in this group. The increased severity of nephropathy in the 15,000 ppm male rats was attributed to the ingestion of manganese (II) sulfate monohydrate.   During the chronic study with mice, groups of 70 male and 70 female mice were fed diets containing 0, 1500, 5000 or 15000 ppm manganese sulphate for 2 years. Animals were sacrificed after 9, 15 and 24 months for full histopathological evaluation.Survival of mice in the 2-year feed study was similar to that of controls. The mean body weights of 15,000 ppm male mice were slightly lower than, but within 5% of, that of the control group throughout the study. Although slight, this decrease may be chemical related. In female mice, the decreases in mean body weights were exposure related; the final mean body weights of the 1,500, 5,000, and 15,000 ppm groups were 6%, 9%, and 13% lower than that of the control group. Toxicity also occurred in the thyroid and forestomach of male and female mice. Incidences of thyroid follicular dilatation and focal hyperplasia in the 15,000 ppm males and females were increased significantly. In the forestomach, the incidence of focal hyperplasia was also increased significantly in the 15,000 ppm males and females and was accompanied by increased incidences of ulceration/erosion and inflammation. The repeated dose toxicity studies conducted on MnSO4 in support of the NTP programme are well conducted and reliable studies and are considered to be the most appropriate source of data on the long-term effects of exposure to the Mn2+ ion via the oral route. As such it is considered appropriate to use these studies to support this endpoint. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd3b030a-97d0-47e9-9d88-182507aacfbe/documents/c1abab3b-b2ba-494d-a276-8a5ca5e9c948_a8a38281-0ea6-49a6-9c43-7d7cd2b42205.html,,,,,, Manganese sulphate,7785-87-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd3b030a-97d0-47e9-9d88-182507aacfbe/documents/c1abab3b-b2ba-494d-a276-8a5ca5e9c948_a8a38281-0ea6-49a6-9c43-7d7cd2b42205.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,110 mg/kg bw/day,,rat Manganese sulphate,7785-87-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd3b030a-97d0-47e9-9d88-182507aacfbe/documents/c1abab3b-b2ba-494d-a276-8a5ca5e9c948_a8a38281-0ea6-49a6-9c43-7d7cd2b42205.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.3 mg/m3,,monkey Manganese sulphate,7785-87-7,"Acute toxicity: oral, Singh (1991) RAT_MnSO4 Under the conditions of this study, the acute oral LD50 for MnSO4 was 2150 mg/kg bw.    Acute toxicity: oral, Singh (1991) MICE_MnSO4 Under the conditions of this study, the acute oral LD50 for MnSO4 was 2330 mg/kg bw.    Acute toxicity: inhalation, Griffiths (2010)_MnSO4 It was considered that the acute inhalation median lethal concentration (4 hr LC50) of MnSO4.H2O, in the HsdHan : WIST strain rat, was greater than 4.98 mg/L. The equivalent LC50 value for the anhydrous form of this material is considered to be >4.45 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd3b030a-97d0-47e9-9d88-182507aacfbe/documents/IUC5-81d24d0e-5efe-404b-96d4-9d3d8dada7ea_a8a38281-0ea6-49a6-9c43-7d7cd2b42205.html,,,,,, Manganese sulphate,7785-87-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd3b030a-97d0-47e9-9d88-182507aacfbe/documents/IUC5-81d24d0e-5efe-404b-96d4-9d3d8dada7ea_a8a38281-0ea6-49a6-9c43-7d7cd2b42205.html,,oral,LD50,"2,150 mg/kg bw",no adverse effect observed, Manganese sulphate,7785-87-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd3b030a-97d0-47e9-9d88-182507aacfbe/documents/IUC5-81d24d0e-5efe-404b-96d4-9d3d8dada7ea_a8a38281-0ea6-49a6-9c43-7d7cd2b42205.html,,inhalation,LC50,> 4.45 mg/L,no adverse effect observed, D-mannose,3458-28-4, 5 -Month drinking water study; mouse; NOAEL for systemic toxicity = 20% (highest dose tested); Reliability = 2 ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/adc9941b-970c-4553-a9b2-2f8e2d0ca0a6/documents/fe97dbb9-f52c-407e-8ff2-be868a22dcea_93db114c-6a1f-4f09-a3f8-c29d64ac4dfb.html,,,,,, D-mannose,3458-28-4, Oral: OECD 425; rat LD50 >5000 mg/kg. Reliability = 1 Inhalation: No study available Dermal: OECD 402; rat LC50 >5000 mg/kg. Reliability = 1 ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/adc9941b-970c-4553-a9b2-2f8e2d0ca0a6/documents/31c9c353-850a-4c59-8846-bc537c288e12_93db114c-6a1f-4f09-a3f8-c29d64ac4dfb.html,,,,,, D-mannose,3458-28-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/adc9941b-970c-4553-a9b2-2f8e2d0ca0a6/documents/31c9c353-850a-4c59-8846-bc537c288e12_93db114c-6a1f-4f09-a3f8-c29d64ac4dfb.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, D-mannose,3458-28-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/adc9941b-970c-4553-a9b2-2f8e2d0ca0a6/documents/31c9c353-850a-4c59-8846-bc537c288e12_93db114c-6a1f-4f09-a3f8-c29d64ac4dfb.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Reaction products of monoethanolamine and boric acid (1:1),26038-87-9," Oral route: A Sub-chronic toxicity study (90-day), oral route (Annex IX, Section 8.6.2.; Test method: EU B.26/OECD TG 408) in rats is proposed to be conducted on Reaction products of monoethanolamine and boric acid 1:3 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6eba4076-cfea-4c08-adcf-14f5366e32c1/documents/c007db9d-f1e5-426d-a18b-3023129ff819_48a22f88-817f-4734-8152-999541861c66.html,,,,,, "Alfalfa, ext.",84082-36-0, LD50 (oral) >3000 mg/kg bw (alfalfa-derived products oral suppplements) LD50 (oral) >2250 mg/kg bw (phyto-preparation of alfalfa extract) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38fa3495-7165-4c2a-b03a-7c03ee73808a/documents/1f1ed8db-0e97-41f1-bd98-2e8c07e8d416_63ec8348-9a1f-43b1-b2dd-04d4425cb372.html,,,,,, "Alfalfa, ext.",84082-36-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38fa3495-7165-4c2a-b03a-7c03ee73808a/documents/1f1ed8db-0e97-41f1-bd98-2e8c07e8d416_63ec8348-9a1f-43b1-b2dd-04d4425cb372.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, Butanone,78-93-3,"In a 90-day inhalation study in Fischer 344 rats, animals were exposed to methyl ethyl ketone (MEK) concentrations at 0 (control), 1254 ppm, 2518 ppm, or 5041 ppm for 6 hours/day, 5 days/week for 89 or 90 consecutive days. This GLP study was equivalent to OECD Test Guideline 413. Although a NOEC was not determined by study authors, based on the data a NOAEC of 5014 ppm can be considered for subchronic inhalation toxicity given that the effects noted in both sexes at 5014 ppm were limited to non specific effects including decreased body weight and increased absolute liver weights and liver to body weight ratios. Supportive studies for MEK were not located. Dermal and oral studies have not been conducted. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9dde2708-22c4-49b5-b4a7-e18e0ca69faf/documents/IUC5-37decc15-a3df-4160-9238-e21472ffcd10_f38860b7-79bf-4db8-88ea-fb34c4517f46.html,,,,,, Butanone,78-93-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9dde2708-22c4-49b5-b4a7-e18e0ca69faf/documents/IUC5-37decc15-a3df-4160-9238-e21472ffcd10_f38860b7-79bf-4db8-88ea-fb34c4517f46.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"14,870 mg/m3",,rat Butanone,78-93-3,"The following information is taken into account for any hazard / risk assessment: Key information on the acute oral toxicity of methyl ethyl ketone (MEK, CAS 78-93-3, EC 201-159-0, also known as 2-butanone) was obtained from data on the read across substance, secondary butyl alcohol (SBA, CAS 78-92-2, EC 201-158-5). SBA is reported to have low acute oral toxicity following oral administration. Reported oral LD50 values of SBA were 2054 mg/kg body weight for males and 2328 mg/kg body weight for females in a study performed similar to test guidelines and in compliance with good laboratory practice. The overall calculated oral LD50 in rats was 2193 mg/kg body weight. Clinical signs included gait and/or posture abnormalities in all rats at all dose levels. In the higher dose groups, some rats were comatose or prostrate within a few hours of dosing, with some animals being unconscious for 24 hours or more.   The dermal LD50 for MEK in male rabbits was reported by Smyth et al. (1962, reliability 2). As discussed below, the study is lacking details, but is deemed reliable. The dermal LD50 in male rabbits is reported to be greater than 10 mL/kg body weight. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9dde2708-22c4-49b5-b4a7-e18e0ca69faf/documents/IUC5-0634a155-5ce5-41a8-b778-298bbab3e205_f38860b7-79bf-4db8-88ea-fb34c4517f46.html,,,,,, Butanone,78-93-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9dde2708-22c4-49b5-b4a7-e18e0ca69faf/documents/IUC5-0634a155-5ce5-41a8-b778-298bbab3e205_f38860b7-79bf-4db8-88ea-fb34c4517f46.html,,oral,LD50,"2,193 mg/kg bw",no adverse effect observed, Butanone,78-93-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9dde2708-22c4-49b5-b4a7-e18e0ca69faf/documents/IUC5-0634a155-5ce5-41a8-b778-298bbab3e205_f38860b7-79bf-4db8-88ea-fb34c4517f46.html,,dermal,LD50,"8,000 mg/kg bw",no adverse effect observed, "Melaleuca alternifolia, ext.",85085-48-9,"Migrated Data from field(s)Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): This study has been assigned a reliability of 1 and meets the information requirements of REACH. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69b92e4a-e867-4745-8fbf-637d789a2217/documents/6f4d18f6-6e21-4485-825b-5df094b6136d_14be6319-b315-4e4e-b7ff-675d93a4d854.html,,,,,, "Melaleuca alternifolia, ext.",85085-48-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69b92e4a-e867-4745-8fbf-637d789a2217/documents/6f4d18f6-6e21-4485-825b-5df094b6136d_14be6319-b315-4e4e-b7ff-675d93a4d854.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,45 mg/kg bw/day,,rat "Melaleuca alternifolia, ext.",85085-48-9,"Migrated Data from field(s)Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Bolt (1989) has been assigned a reliability of 2. Kubaszky (2010) has been assigned a reliability of 1. Both studies meet the information requirements of REACH.Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): This study has been assigned a reliability of 1 and meets the information requirements of REACH.Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): This study has been assigned a reliability of 2 and meets the information requirements of REACH. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69b92e4a-e867-4745-8fbf-637d789a2217/documents/f94fabe9-51fb-41b6-9974-dae44b92a4e6_14be6319-b315-4e4e-b7ff-675d93a4d854.html,,,,,, "Melaleuca alternifolia, ext.",85085-48-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69b92e4a-e867-4745-8fbf-637d789a2217/documents/f94fabe9-51fb-41b6-9974-dae44b92a4e6_14be6319-b315-4e4e-b7ff-675d93a4d854.html,,oral,LD50,"1,691 mg/kg bw",adverse effect observed, "Melaleuca alternifolia, ext.",85085-48-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69b92e4a-e867-4745-8fbf-637d789a2217/documents/f94fabe9-51fb-41b6-9974-dae44b92a4e6_14be6319-b315-4e4e-b7ff-675d93a4d854.html,,inhalation,LC50,"4,780 mg/m3",adverse effect observed, "Cajuput, ext.",85480-37-1,"Acute toxicity, oral: LD50 = 3870 mg/kg bw (WoE). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/714493e7-5f6e-4e3d-b7f5-2783dd93f42c/documents/IUC5-0b46fc2b-ceed-447e-95d8-5b1979eea6bc_8a3967fe-4e19-4c09-95f5-00ec678c8577.html,,,,,, "Cajuput, ext.",85480-37-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/714493e7-5f6e-4e3d-b7f5-2783dd93f42c/documents/IUC5-0b46fc2b-ceed-447e-95d8-5b1979eea6bc_8a3967fe-4e19-4c09-95f5-00ec678c8577.html,,oral,LD50,"3,870 mg/kg bw",no adverse effect observed, Melaleuca viridiflora extract,132940-73-9,"Acute toxicity, oral: LD50 cut-off = 2500 mg/kg bw (K). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/232a710f-b14b-43a8-8e3f-1248684456fd/documents/IUC5-28f15085-cc8a-48ef-8b07-0cdd1b987210_c550eabc-26c7-4bdf-bbf7-69c804e76275.html,,,,,, Melaleuca viridiflora extract,132940-73-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/232a710f-b14b-43a8-8e3f-1248684456fd/documents/IUC5-28f15085-cc8a-48ef-8b07-0cdd1b987210_c550eabc-26c7-4bdf-bbf7-69c804e76275.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Melamine,108-78-1,"When tested in oral repeated dose toxicity studies in rats, melamine caused formation of urinary calculi in the bladder and hyperplasia in the bladder epithelium of both sexes. The effects were dose-related, with the male rats being more sensitive than females to the effects in the bladder. Mice were also investigated: The incidence of bladder stones was dose related as in rats, being greater in males than in females, but starting at much higher doses than in rats. In a newer subchronic study with monkeys the kidney was also the primary target organ. A NOAEL of 60 mg/kg/d was obtained, much the same as in the rat study, but it should be considered that the study is of poor reliability. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e54db5c-6cea-4045-bb5f-b2734a2be8f3/documents/IUC5-7fae6773-7a04-4a5d-b7a1-543259c118e3_4e72b4e3-9b31-4fdc-a8d5-6bc9939e1a8a.html,,,,,, Melamine,108-78-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e54db5c-6cea-4045-bb5f-b2734a2be8f3/documents/IUC5-7fae6773-7a04-4a5d-b7a1-543259c118e3_4e72b4e3-9b31-4fdc-a8d5-6bc9939e1a8a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,72 mg/kg bw/day,,rat Melamine,108-78-1,"Melamine has a low acute toxicity by the oral, dermal and inhalation route. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e54db5c-6cea-4045-bb5f-b2734a2be8f3/documents/IUC5-2f99ca88-b0ae-433a-991e-e549bec60195_4e72b4e3-9b31-4fdc-a8d5-6bc9939e1a8a.html,,,,,, Melamine,108-78-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e54db5c-6cea-4045-bb5f-b2734a2be8f3/documents/IUC5-2f99ca88-b0ae-433a-991e-e549bec60195_4e72b4e3-9b31-4fdc-a8d5-6bc9939e1a8a.html,,oral,LD50,"3,161 mg/kg bw",, "Octahydro-4,7-methano-1H-indenecarbaldehyde",30772-79-3,Acute oral toxicity: OECD TG 401: > 2075 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/171f901c-6ce4-42fc-afda-c9e3be491725/documents/IUC5-b53d28de-f01b-4d90-809a-94cec6e6ac38_124bc863-8f61-4cf9-8430-50eb243d1cf9.html,,,,,, Menadione,58-27-5," In two internal references on oral toxicity, the LD50 for rats is determined to be 940 ± 150 and 1100 ± 116 mg/kg. In three studies in mice, the oral LD50 has been reported to be 350 ± 30, 1030 ± 165, and 500 mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a3031e1-33ef-4411-8c46-5cb6b6967c09/documents/0b134cd4-67f4-438d-b8d8-044f4bd251eb_163d1e8c-5f9f-4b56-8b01-a796f982a720.html,,,,,, Menadione,58-27-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a3031e1-33ef-4411-8c46-5cb6b6967c09/documents/0b134cd4-67f4-438d-b8d8-044f4bd251eb_163d1e8c-5f9f-4b56-8b01-a796f982a720.html,,oral,LD50,350 mg/kg bw,adverse effect observed, "Mentha arvensis, ext.",90063-97-1," 28-d oral repeated dose toxicity study with peppermint oil: NOAEL 400 mg/kg bw/day based on absence of effects at the highest dose tested (Serota, 1990) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e42a97b-440d-4e77-b522-4e81437d76ec/documents/IUC5-c30e54be-32d8-4d9b-9d47-a14e37a634f8_ab9a7c7c-d842-4ae7-a49d-f315ec5c5d4d.html,,,,,, "Mentha arvensis, ext.",90063-97-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e42a97b-440d-4e77-b522-4e81437d76ec/documents/IUC5-c30e54be-32d8-4d9b-9d47-a14e37a634f8_ab9a7c7c-d842-4ae7-a49d-f315ec5c5d4d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat "Mentha arvensis, ext.",90063-97-1, Acute toxicity oral (rat): LD50: 1240 mg/kg bw (no guideline followed) Acute toxicity dermal (rabbit): LD50 > 5000 mg/kg bw (no guideline followed) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e42a97b-440d-4e77-b522-4e81437d76ec/documents/IUC5-b37b23e9-1199-497f-bfc9-0d69a07ca77d_ab9a7c7c-d842-4ae7-a49d-f315ec5c5d4d.html,,,,,, "Mentha arvensis, ext.",90063-97-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e42a97b-440d-4e77-b522-4e81437d76ec/documents/IUC5-b37b23e9-1199-497f-bfc9-0d69a07ca77d_ab9a7c7c-d842-4ae7-a49d-f315ec5c5d4d.html,,oral,LD50,"1,240 mg/kg bw",adverse effect observed, "Mentha arvensis, ext.",90063-97-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e42a97b-440d-4e77-b522-4e81437d76ec/documents/IUC5-b37b23e9-1199-497f-bfc9-0d69a07ca77d_ab9a7c7c-d842-4ae7-a49d-f315ec5c5d4d.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Mentha citrata, ext.",85085-49-0," Repeated dose toxicity: Oral The no observed Adverse Effect Level (NOAEL) for the test chemical Mentha citrata, ext for a duration of chronic toxicity study is considered to be 500 mg/Kg bw. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d81239e-f134-43cd-9cbe-45f77d60fe8d/documents/f206a5bb-22b0-4714-97c1-f44316deecc8_d33ed51b-5cfe-459e-9e2e-c03a70eee732.html,,,,,, "Mentha citrata, ext.",85085-49-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d81239e-f134-43cd-9cbe-45f77d60fe8d/documents/f206a5bb-22b0-4714-97c1-f44316deecc8_d33ed51b-5cfe-459e-9e2e-c03a70eee732.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Mentha citrata, ext.",85085-49-0," Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Mentha citrata, ext. (85085-49-0).The studies are as mentioned below: 1.Acute oral toxicity study was performed in groups of 5 male and female Osborne-Mendel rats using test chemical.LD50s were computed by the method of Litchfield & Wilcoxon (1949).50% mortality was observed at dose 2790 mg/kg bw.Death occurred within 4-18 hours after treatment. In clinical signs observations, Behavioral ataxia (soon after Treatment) was observed.Hence,LD50 value was considered to be 2790 mg/kg bw(95% C. I.: 2440-3180 mg/kg bw),when groups of 5 male and female Osborne-Mendel rats were treated with test chemical orally via gavage following 14 days of observation period. 2.Acute oral toxicity study was performed in groups of 5 male and female Osborne-Mendel rats using test chemical.LD50s were computed by the method of Litchfield & Wilcoxon (1949).50% mortality was observed at dose 14550 mg/kg bw.In clinical signs observations,animals showed depression soon after treatment, coma and wet posterior.Hence,LD50 value was considered to be14550 mg/kg bw(95 %C. I.: 12,300-17,170 mg/kg bw),when groups of 5 male and female Osborne-Mendel rats were treated with test chemical orally via gavage following 14 days of observation period. Thus, based on the above summarised studies,Mentha citrata, ext. (85085-49-0) and it’s structurally similar read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,Mentha citrata, ext. (85085-49-0) cannot be classified for acute oral toxicity.Hence, based on the data available for the structurally similar read across, test chemical Mentha citrata, ext. (85085-49-0) is not likely to be toxic at the dose of 14550 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d81239e-f134-43cd-9cbe-45f77d60fe8d/documents/5d86e112-ebfd-438b-8f9a-d6326bfc2f0e_d33ed51b-5cfe-459e-9e2e-c03a70eee732.html,,,,,, "Mentha citrata, ext.",85085-49-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d81239e-f134-43cd-9cbe-45f77d60fe8d/documents/5d86e112-ebfd-438b-8f9a-d6326bfc2f0e_d33ed51b-5cfe-459e-9e2e-c03a70eee732.html,,oral,LD50,"14,550 mg/kg bw",no adverse effect observed, "Peppermint, ext.",84082-70-2,"28-d oral repeated dose toxicity study with peppermint oil: NOAEL 400 mg/kg bw/day based on absence of effects at the highest dose tested (Serota, 1990) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9db08bf0-662a-4cf6-8413-fe0289d6e956/documents/IUC5-47814281-28ce-4a79-9ffc-24c83e02ac52_e22e8aa0-f230-4d94-a20c-ea338a9fa25f.html,,,,,, "Peppermint, ext.",84082-70-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9db08bf0-662a-4cf6-8413-fe0289d6e956/documents/IUC5-47814281-28ce-4a79-9ffc-24c83e02ac52_e22e8aa0-f230-4d94-a20c-ea338a9fa25f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat "Peppermint, ext.",84082-70-2,Acute toxicity oral:- Standard acute method (Rat): LD50 = 2650 mg/kg (95% CI >= 2300 - <= 3000) (similar to OECD guideline 401)Acute toxicity dermal:- Standard actue method (Rabbit): LD50 > 5000 mg/kg bw (similar to OECD guideline 402) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9db08bf0-662a-4cf6-8413-fe0289d6e956/documents/IUC5-4adebc8a-03fd-478a-8b99-7f423ccd09e9_e22e8aa0-f230-4d94-a20c-ea338a9fa25f.html,,,,,, "Peppermint, ext.",84082-70-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9db08bf0-662a-4cf6-8413-fe0289d6e956/documents/IUC5-4adebc8a-03fd-478a-8b99-7f423ccd09e9_e22e8aa0-f230-4d94-a20c-ea338a9fa25f.html,,oral,LD50,"2,650 mg/kg bw",adverse effect observed, "Peppermint, ext.",84082-70-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9db08bf0-662a-4cf6-8413-fe0289d6e956/documents/IUC5-4adebc8a-03fd-478a-8b99-7f423ccd09e9_e22e8aa0-f230-4d94-a20c-ea338a9fa25f.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "ethyl 2-[[(1R,2S,5R)-5-methyl-2-propan-2-ylcyclohexanecarbonyl]amino]acetate",68489-14-5," In a key study performed accoridng to OECD TG 423, fasted  female rats were treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed  by a further group of three fasted  females at the same dose level. The clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. The results showed that there were no deaths observed after the treatment. Using the mortality data obtained, an estimate of the acute oral median lethal dose (LD50)  of the test material, WS-5, was calculated. LD50 was determined to be >2500 mg/kg/bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/521a5ab7-e566-4294-9675-e965742fad99/documents/f4e8f7fc-0f03-4519-80d1-a4ac48d1bf93_9a3be6a8-3fad-477c-871e-b988d33bee57.html,,,,,, "ethyl 2-[[(1R,2S,5R)-5-methyl-2-propan-2-ylcyclohexanecarbonyl]amino]acetate",68489-14-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/521a5ab7-e566-4294-9675-e965742fad99/documents/f4e8f7fc-0f03-4519-80d1-a4ac48d1bf93_9a3be6a8-3fad-477c-871e-b988d33bee57.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, DL-menthol,1490-04-6,In a valid 2 years oral feed study in rats the NOAELs were 375 mg/kg bw/d for male rats and 667 mg/kg bw/d for male and female mice. For female rats the NOAEL is 188 mg/kg based on slightly reduced body weight at 375 mg/kg bw. For repeated dermal and inhalative toxicity no vailid studies are available. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e555ff2-a21e-47cc-a576-228e3ff48f54/documents/IUC5-35978aef-8eb1-4771-8bf9-a09cfc2de6d1_037166d0-7728-4546-aa6b-968d834a2504.html,,,,,, DL-menthol,1490-04-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e555ff2-a21e-47cc-a576-228e3ff48f54/documents/IUC5-35978aef-8eb1-4771-8bf9-a09cfc2de6d1_037166d0-7728-4546-aa6b-968d834a2504.html,Chronic toxicity – systemic effects,oral,NOAEL,188 mg/kg bw/day,,rat DL-menthol,1490-04-6,"The studies on acute oral toxicity were not performed according to guideline methods. However, the number of treated animals and the used protocols are scientifically acceptable to evaluate this endpoint sufficiently. A valid study on acute inhalation toxicity according OECD TG 403 was conducted ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e555ff2-a21e-47cc-a576-228e3ff48f54/documents/IUC5-3b023869-c901-47e3-b989-4d0e7bbe2345_037166d0-7728-4546-aa6b-968d834a2504.html,,,,,, DL-menthol,1490-04-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e555ff2-a21e-47cc-a576-228e3ff48f54/documents/IUC5-3b023869-c901-47e3-b989-4d0e7bbe2345_037166d0-7728-4546-aa6b-968d834a2504.html,,oral,LD50,"3,180 mg/kg bw",, DL-menthol,1490-04-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e555ff2-a21e-47cc-a576-228e3ff48f54/documents/IUC5-3b023869-c901-47e3-b989-4d0e7bbe2345_037166d0-7728-4546-aa6b-968d834a2504.html,,inhalation,LC50,"5,289 mg/m3",, L-menthol,2216-51-5,"No effects were observed in life-time (103 weeks) studies in rats and mice by using DL Menthol up to the highest tested dose equalling 375 mg/kg bw/day for the rat and 667 mg/kg bw/day for the mouse. In a 90-day feeding study with DL Menthol the NOAEL was 937 mg/kg bw/d for rats (highest dose tested). In a 90-day feeding study the NOAEL was 1250 mg/kg bw/d for mice based on slightly reduced body weight gain.As no sytemic effects were seen in both 103 weeks repeated dose toxicity studies applied by oral route, repeated dose studies via dermal or inhalative route do not appear to be scientifically justified. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b82dca9b-7a65-4bbc-92a1-9a2e7b354204/documents/IUC5-b6feb396-b8fc-4175-ab44-5646a46c5897_af9e8385-2422-4f51-a125-6117283a17f5.html,,,,,, L-menthol,2216-51-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b82dca9b-7a65-4bbc-92a1-9a2e7b354204/documents/IUC5-b6feb396-b8fc-4175-ab44-5646a46c5897_af9e8385-2422-4f51-a125-6117283a17f5.html,Chronic toxicity – systemic effects,oral,NOAEL,375 mg/kg bw/day,,rat L-menthol,2216-51-5,"Low acute toxicity for oral route (LD50 >2000 mg/kg bw).Low acute toxicity dermal (LD50 >5000 mg/kg bw)Low acute toxicity inhalative (LC50 (aerosol, 4h) 5289 mg/m3) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b82dca9b-7a65-4bbc-92a1-9a2e7b354204/documents/IUC5-cd2410ae-777d-498b-b52e-43751ccedb7f_af9e8385-2422-4f51-a125-6117283a17f5.html,,,,,, L-menthol,2216-51-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b82dca9b-7a65-4bbc-92a1-9a2e7b354204/documents/IUC5-cd2410ae-777d-498b-b52e-43751ccedb7f_af9e8385-2422-4f51-a125-6117283a17f5.html,,oral,LD50,"2,615 mg/kg bw",, L-menthol,2216-51-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b82dca9b-7a65-4bbc-92a1-9a2e7b354204/documents/IUC5-cd2410ae-777d-498b-b52e-43751ccedb7f_af9e8385-2422-4f51-a125-6117283a17f5.html,,dermal,LD50,"5,000 mg/kg bw",, L-menthol,2216-51-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b82dca9b-7a65-4bbc-92a1-9a2e7b354204/documents/IUC5-cd2410ae-777d-498b-b52e-43751ccedb7f_af9e8385-2422-4f51-a125-6117283a17f5.html,,inhalation,LC50,"5,289 mg/m3",, Menthol,89-78-1,In a valid 2 years oral feed study in rats the NOAELs were 375 mg/kg bw/d for male rats and 667 mg/kg bw/d for male and female mice. For female rats the NOAEL is 188 mg/kg based on slightly reducedbody weight at 375 mg/kg bw. For repeated dermal and inhalative toxicity no valid studies are available. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b05294ba-4ec0-4a1c-a915-24b71a0ed803/documents/IUC5-1f31b013-adca-4965-aaba-2de2b8958601_35ecf32a-341b-464d-9bbf-37ba51da23e8.html,,,,,, Menthol,89-78-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b05294ba-4ec0-4a1c-a915-24b71a0ed803/documents/IUC5-1f31b013-adca-4965-aaba-2de2b8958601_35ecf32a-341b-464d-9bbf-37ba51da23e8.html,Chronic toxicity – systemic effects,oral,NOAEL,188 mg/kg bw/day,,rat Menthol,89-78-1,"The studies on acute oral toxicity were not performed according to guideline methods. However, thenumber of treated animals and the used protocols are scientifically acceptable to evaluate this endpointsufficiently.A valid study on acute inhalation toxicity according OECD TG 403 was conducted. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b05294ba-4ec0-4a1c-a915-24b71a0ed803/documents/IUC5-3ddb00a4-f27f-4b66-9bb0-878c0a5c6073_35ecf32a-341b-464d-9bbf-37ba51da23e8.html,,,,,, Menthol,89-78-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b05294ba-4ec0-4a1c-a915-24b71a0ed803/documents/IUC5-3ddb00a4-f27f-4b66-9bb0-878c0a5c6073_35ecf32a-341b-464d-9bbf-37ba51da23e8.html,,oral,LD50,"3,180 mg/kg bw",no adverse effect observed, Menthol,89-78-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b05294ba-4ec0-4a1c-a915-24b71a0ed803/documents/IUC5-3ddb00a4-f27f-4b66-9bb0-878c0a5c6073_35ecf32a-341b-464d-9bbf-37ba51da23e8.html,,inhalation,LC50,"5,289 mg/m3",adverse effect observed, trans-menthone,89-80-5," Repeated dose toxicity: Oral Repeated dose subacute oral toxicity study of the test chemical was assessed for its possible toxic potential .For this purpose 28 days Sub acute study was conducted in male and female Wistar rats by oral gavage. The test animals were exposed at the concentration of 0, 200, 400 and 800 mg/kg/bw day for 28 days. As the female rats in the highest dose group showed serious weakening after 19 days of dosing the dose was reduced to 400 mgikg. The average doses for the female groups were 0, 200, 400 and 671 mg/kg b.w./day. The animals were observed for mortality, clinical sign, food consumption, body weight, clinical chemistry, organ weight, Histopathology. Significant effects in clinical chemistry organ weight and histopathology were observed at the dose concentration of 400and 800 mg/kg/bw day. No significant effect was observed at the 200 mg/kg/bw day. Therefore the No observed adverse effect level (NOAEL) was considered to be less than 200 mg/kgbw/ day in male and female wistar rats for Menthone for 28 days sub acute toxicity study by oral gavage. Repeated dose toxicity : Inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance Menthone ; IUPAC name;(2R,5S)-5-methyl-2-(propan-2-yl)cyclohexan-1-one (CAS no 89-80-5) ,which is reported as 0.0002775228 mmHg at temperature 25 Deg C. Thus, exposure to inhalable dust, mist and vapour of the chemical 4-tert-butylcyclohexanol  is highly unlikely. Therefore this study is considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value forMenthone ; IUPAC name;(2R,5S)-5-methyl-2-(propan-2-yl)cyclohexan-1-one (CAS no. 89-80-5)(as provided in section 7.2.3) is >5000 mg/kg body weight. The substance was also found to be not irritating and not sensitizing to the skin. Considering this, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91031c1a-126f-4d99-84fa-7d0f6625cfd9/documents/d296f6b1-94cc-4b2d-860b-0de3c33de08c_71716edc-0942-43ed-8aa6-e31c9d3571a5.html,,,,,, trans-menthone,89-80-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91031c1a-126f-4d99-84fa-7d0f6625cfd9/documents/d296f6b1-94cc-4b2d-860b-0de3c33de08c_71716edc-0942-43ed-8aa6-e31c9d3571a5.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,200 mg/kg bw/day,,rat trans-menthone,89-80-5," Acute oral toxicity:  Acute oral toxicity dose (LD50) of target chemical (2R, 5S)-5-methyl-2-(propan-2-yl)cyclohexan-1-one (CAS no.: 89-80-5) was considered to be 1950 mg/kg bw; in the range between 1600-1950 mg/kg bw; 500 mg/kg bw; Further LD50 value was predicted based on OECD QSAR toolbox, the value estimated to be 1871 mg/kg bw; LD50 value was predicted based on Danish QSAR, the value estimated to be 1500 mg/kg bw; and different studies available for the structurally similar read across substances, the LD50 was considered to be 1200 mg/kg bw; and 470 mg/kg bw. All these studies concluded that the LD50 value is between 300-2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, (2R, 5S)-5-methyl-2-(propan-2-yl)cyclohexan-1-one can be classified as “Category 4” for acute oral toxicity. Acute Inhalation Toxicity:  According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance Menthone ; IUPAC name;(2R,5S)-5-methyl-2-(propan-2-yl)cyclohexan-1-one (CAS no 89-80-5) ,which is reported as 0.0002775228 mmHg at temperature 25 Deg C. Thus, exposure to inhalable dust, mist and vapour of the chemical 4-tert-butylcyclohexanol is highly unlikely. Therefore this study is considered for waiver. Acute Dermal Toxicity: In Acute dermal toxicity, LD50 value for target substance (2R, 5S)-5-methyl-2-(propan-2-yl)cyclohexan-1-one (CAS no.: 89-80-5) was considered to be >5000 mg/kg bw,and for differentstudies available on structurally similar read across substance was considered to be >5000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, (2R, 5S)-5-methyl-2-(propan-2-yl)cyclohexan-1-one (CAS no.: 89-80-5) cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91031c1a-126f-4d99-84fa-7d0f6625cfd9/documents/bb382fd8-258b-4e48-ab22-391156c922f4_71716edc-0942-43ed-8aa6-e31c9d3571a5.html,,,,,, trans-menthone,89-80-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91031c1a-126f-4d99-84fa-7d0f6625cfd9/documents/bb382fd8-258b-4e48-ab22-391156c922f4_71716edc-0942-43ed-8aa6-e31c9d3571a5.html,,oral,LD50,"1,950 mg/kg bw",adverse effect observed, trans-menthone,89-80-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91031c1a-126f-4d99-84fa-7d0f6625cfd9/documents/bb382fd8-258b-4e48-ab22-391156c922f4_71716edc-0942-43ed-8aa6-e31c9d3571a5.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-hydroxymethyl-9-methyl-6-(1-methylethyl)-1,4-dioxaspiro[4.5]decane",63187-91-7,Both the dermal and the oral LD50 value of the test substance in rats of either sex are exceeding 2000 mg/kg body weight. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6eac4442-4ae5-4677-b886-f8e654a0a39c/documents/IUC5-c8f27e09-f38a-418f-bb2d-7a2f1fb314f0_94627334-2642-4e9e-8a5d-334f9e0f7978.html,,,,,, "2-hydroxymethyl-9-methyl-6-(1-methylethyl)-1,4-dioxaspiro[4.5]decane",63187-91-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6eac4442-4ae5-4677-b886-f8e654a0a39c/documents/IUC5-c8f27e09-f38a-418f-bb2d-7a2f1fb314f0_94627334-2642-4e9e-8a5d-334f9e0f7978.html,,oral,LD50,"5,716 mg/kg bw",adverse effect observed, "3-[[5-methyl-2-(1-methylethyl)cyclohexyl]oxy]propane-1,2-diol",87061-04-9," 3-L-Menthoxypropane-1,2-diol (Takasago Coolact 10) when administered in diet for 28 days to male and female Sprague-Dawley (Crl:CD®BR) rats at dose levels of 250, 500, 1000, 2000 and 5000 mg/kg bw/day, revealed a lowest observed adverse effect level (LOAEL) at 250 mg/kg bw/day for male and female rats (based on adverse effects observed in clinical chemistry and organ weights observed at this dose level). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6dc7ef59-5df8-4229-b4f6-ebf820498195/documents/81c83654-1407-45d1-88cf-7c7eea8ae1c9_58808192-063c-4caa-8e68-03f2344e2fcc.html,,,,,, "3-[[5-methyl-2-(1-methylethyl)cyclohexyl]oxy]propane-1,2-diol",87061-04-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6dc7ef59-5df8-4229-b4f6-ebf820498195/documents/81c83654-1407-45d1-88cf-7c7eea8ae1c9_58808192-063c-4caa-8e68-03f2344e2fcc.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,250 mg/kg bw/day,,rat "3-[[5-methyl-2-(1-methylethyl)cyclohexyl]oxy]propane-1,2-diol",87061-04-9," Key study:- Ianamoto (1999), Acute toxicity oral (OECD 420): LD50 > 2000 mg/kg bw (male/female rats) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6dc7ef59-5df8-4229-b4f6-ebf820498195/documents/IUC5-ea4d2384-0bf5-4da0-9f08-d43394f3ad89_58808192-063c-4caa-8e68-03f2344e2fcc.html,,,,,, Menthyl acetate,89-48-5,Read-across compound DL-menthol is not toxic in rats when applied daily by oral route (feed) at a dose of 375 mg/kg bw/day for 103 weeks (corresponding to a NOEL for menthyl acetate of 476 mg/kg bw/day). ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7cf52de-c4ef-4948-b5d1-af0e87fa2472/documents/IUC5-6824afe1-d4ac-4178-af17-bea67e142979_b95fc015-73a6-4b93-b41e-9af857dbde84.html,,,,,, Menthyl acetate,89-48-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7cf52de-c4ef-4948-b5d1-af0e87fa2472/documents/IUC5-6824afe1-d4ac-4178-af17-bea67e142979_b95fc015-73a6-4b93-b41e-9af857dbde84.html,Chronic toxicity – systemic effects,oral,NOAEL,476 mg/kg bw/day,,rat Menthyl acetate,89-48-5,Oral: LD50 > 5000 mg/kg body weight leading to not classification according to CLPDermal: LD50 > 5000 mg/kg body weight leading to not classification according to CLPInhalation: no information available ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7cf52de-c4ef-4948-b5d1-af0e87fa2472/documents/IUC5-3dc9e21f-2963-4c43-841e-d2bc8d01faf4_b95fc015-73a6-4b93-b41e-9af857dbde84.html,,,,,, "(1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexyl (ethylamino)(oxo)acetate",1122460-01-8,"Acute oral toxicity: LD50 > 2000 mg/kg bw (equivalent or similar to EU Method B.1 bis, GLP compliant)Acute inhalation toxicity: data waivingAcute dermal toxicity: LD50 > 2000 mg/kg bw (EU method B.3, GLP compliant) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/868512b8-999b-4a90-ad29-527dd271ec40/documents/IUC5-da884ed5-d43c-4713-bf6c-2c886a9db068_df6f65fd-3e7d-4cbd-a4bf-0269917576cd.html,,,,,, "(1R,2S,5R)-5-methyl-2-(propan-2-yl)cyclohexyl (ethylamino)(oxo)acetate",1122460-01-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/868512b8-999b-4a90-ad29-527dd271ec40/documents/IUC5-da884ed5-d43c-4713-bf6c-2c886a9db068_df6f65fd-3e7d-4cbd-a4bf-0269917576cd.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 5-methyl-2-(isopropyl)cyclohexyl nicotinate,40594-65-8, Non toxic ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/891db6b9-29da-4018-bdac-cccf26261c5e/documents/437a3f7f-032a-4a83-8f5e-6831b94bf8ce_101dca73-b9ee-4ec5-bb57-d7be25153d9c.html,,,,,, 5-methyl-2-(isopropyl)cyclohexyl nicotinate,40594-65-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/891db6b9-29da-4018-bdac-cccf26261c5e/documents/437a3f7f-032a-4a83-8f5e-6831b94bf8ce_101dca73-b9ee-4ec5-bb57-d7be25153d9c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "[1R-(1α,2β,5α)]-2-isopropyl-5-methylcyclohexyl 5-oxo-L-prolinate",64519-44-4," In an acute oral toxicity study in rats (OECD 420) , the oral LD50 was found to be higher than 2000 mg/kg bw (GLP, K, Rel. 1) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fc6d460-61da-4f01-9c5c-d95597060688/documents/1d1492cf-3fd4-4440-9a03-b6b9a5ed7304_1b42d3cb-c40c-4aff-82df-d353dd28eb52.html,,,,,, "[1R-(1α,2β,5α)]-2-isopropyl-5-methylcyclohexyl 5-oxo-L-prolinate",64519-44-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fc6d460-61da-4f01-9c5c-d95597060688/documents/1d1492cf-3fd4-4440-9a03-b6b9a5ed7304_1b42d3cb-c40c-4aff-82df-d353dd28eb52.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-mercaptopropionic acid,107-96-0,A 28-day oral toxicity study with the methyl ester of 3-mercaptopropionic acid (MMP) in rats showed only minor effects on organ weights as well as forestomach hyperplasia at the highest dose level (100 mg/kg/day). These effects are not adverse or relevant for human risk assessment. The NOAEL of MMP is equivalent to a NOAEL of 88.3 mg/kg/d for 3-mercaptopropionic acid (3-MPA). ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3af9a4dd-3282-4b81-921e-2320b86de26b/documents/IUC5-08e97de5-e3e5-4812-9e12-bd6db735e48b_3f180799-8347-4f62-9660-3b97f5eb9ea4.html,,,,,, 3-mercaptopropionic acid,107-96-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3af9a4dd-3282-4b81-921e-2320b86de26b/documents/IUC5-08e97de5-e3e5-4812-9e12-bd6db735e48b_3f180799-8347-4f62-9660-3b97f5eb9ea4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,88.3 mg/kg bw/day,,rat 3-mercaptopropionic acid,107-96-0,3-MPA is highly corrosive. Percutaneous toxicity cannot be determined because of the corrosivity of 3-MPA. High dose inhalation exposure caused irritation of the respiratory tract which finally led to mortality. 3-MPA is toxic if swallowed and harmful by inhalation. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3af9a4dd-3282-4b81-921e-2320b86de26b/documents/IUC5-a69ae87b-185b-4481-a4f6-643a48d61606_3f180799-8347-4f62-9660-3b97f5eb9ea4.html,,,,,, 3-mercaptopropionic acid,107-96-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3af9a4dd-3282-4b81-921e-2320b86de26b/documents/IUC5-a69ae87b-185b-4481-a4f6-643a48d61606_3f180799-8347-4f62-9660-3b97f5eb9ea4.html,,oral,LD50,120 mg/kg bw,adverse effect observed, 3-mercaptopropionic acid,107-96-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3af9a4dd-3282-4b81-921e-2320b86de26b/documents/IUC5-a69ae87b-185b-4481-a4f6-643a48d61606_3f180799-8347-4f62-9660-3b97f5eb9ea4.html,,inhalation,LC50,"1,818 mg/m3",adverse effect observed, 3-trimethoxysilylpropane-1-thiol,4420-74-0,"There are no sub-chronic toxicity studies for the registered substance 3-(trimethoxysilyl)propane-1-thiol (CAS No. 4420-74-0, EC No. 224-588-5). Therefore, the endpoint is fulfilled using read across of a study on the analogue substance, 3-(triethoxysilyl)propanethiol (CAS No. 14814-09-6, EC No. 238-883-1).   In the key study conducted according to OECD Test Guideline 408 and in compliance with GLP (Charles River Laboratories, 2022a, reliability score 1), Wistar Han rats were administered the analogue substance 3-(triethoxysilyl)propanethiol (CAS No. 14814-09-6, EC No. 238-883-1) at 0, 100, 300, and 900 mg/kg bw/day via oral gavage (corn oil vehicle) for 7 days/week over 13 weeks. The systemic NOAEL for 3-(triethoxysilyl)propanethiol was <100 mg/kg bw/day, based on degenerative renal effects in females at 100 mg/kg bw/day (tubular degeneration and inflammatory cell infiltrates). For males, the systemic NOAEL was 100 mg/kg bw/day, based on renal effects starting at 300 mg/kg bw/day (above findings plus granular casts and papillary necrosis at 900 mg/kg bw/day). Additional adverse findings at 900 mg/kg bw/day included clinical signs in both sexes, lower body weight / food consumption in males, and urinary bladder and ureter histopathology with micro- and/or macroscopic correlates in males. For local effects in the stomach (glandular and/or non-glandular), the NOAELs for females and males were 100 and 300 mg/kg bw/day, respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc77f0e8-5a0e-45f6-b520-9f9fc9ebc431/documents/f1b64e7d-489b-46e5-80a6-43714f1483e2_aa720684-fa39-40f6-8d16-c2436971d60d.html,,,,,, 3-trimethoxysilylpropane-1-thiol,4420-74-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc77f0e8-5a0e-45f6-b520-9f9fc9ebc431/documents/f1b64e7d-489b-46e5-80a6-43714f1483e2_aa720684-fa39-40f6-8d16-c2436971d60d.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat 3-trimethoxysilylpropane-1-thiol,4420-74-0,"The following key studies are available for the acute toxicity of 3-(trimethoxysilyl)propane-1-thiol (CAS 4420-74-0; EC 224-588-5):   The key study for acute oral toxicity (Eurofins, 2018a) was conducted according to OECD 423 and in compliance with GLP. The acute oral LD50 was identified to be 500 mg/kg bw for female rats.   The key study for acute dermal toxicity (BRRC 1990) was conducted according to a test protocol that is comparable to the appropriate OECD Test Guideline 402, but not in compliance with GLP. The acute dermal LD50 was identified to be 2497 mg/kg bw for males and 2172 mg/kg bw for females.   The key acute inhalation toxicity study (BRRC 1990) was conducted according to a protocol similar to OECD Test Guideline 403, not in compliance with GLP. 3-Trimethoxysilylpropane-1-thiol did not cause any deaths in Sprague-Dawley rats following a six hour exposure to saturated vapour.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc77f0e8-5a0e-45f6-b520-9f9fc9ebc431/documents/c1241a58-f380-46f8-aff3-4bc2f7acf1f0_aa720684-fa39-40f6-8d16-c2436971d60d.html,,,,,, 3-trimethoxysilylpropane-1-thiol,4420-74-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc77f0e8-5a0e-45f6-b520-9f9fc9ebc431/documents/c1241a58-f380-46f8-aff3-4bc2f7acf1f0_aa720684-fa39-40f6-8d16-c2436971d60d.html,,oral,LD50,500 mg/kg bw,adverse effect observed, 3-trimethoxysilylpropane-1-thiol,4420-74-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc77f0e8-5a0e-45f6-b520-9f9fc9ebc431/documents/c1241a58-f380-46f8-aff3-4bc2f7acf1f0_aa720684-fa39-40f6-8d16-c2436971d60d.html,,dermal,LD50,"2,172 mg/kg bw",no adverse effect observed, Methacrylamide,79-39-0," Oral chronic NOAEL systemic, rat, drinking water: ca. 20 mg/kg bw/d (based on neurotoxic effects) subacute NOAEL systemic, rat, gavage: <30 mg/kg bw/d for females; 30 mg/kg bw/d for males (OECD 407, based on neurotoxic effects) NOAEL systemic, rat, gavage: 12.5 bw/d (OECD 421 screening, based on bw effects) Inhalation subchronic, OECD 413, rat, aerosol NOAEL systemic: 62.5 mg/m3 (no effects observed) NOAEL local: 10 mg/m3 (effects on the olfactory mucosa) Dermal no reliable studies available ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34553733-ad77-428e-942b-95e82c081a04/documents/499c4cc6-4d1e-4de6-ad84-1803f9432f8f_3dbea803-99e8-4f8d-851b-1e47934eb1df.html,,,,,, Methacrylamide,79-39-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34553733-ad77-428e-942b-95e82c081a04/documents/499c4cc6-4d1e-4de6-ad84-1803f9432f8f_3dbea803-99e8-4f8d-851b-1e47934eb1df.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,62.5 mg/m3,,rat Methacrylamide,79-39-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34553733-ad77-428e-942b-95e82c081a04/documents/499c4cc6-4d1e-4de6-ad84-1803f9432f8f_3dbea803-99e8-4f8d-851b-1e47934eb1df.html,Chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat Methacrylamide,79-39-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34553733-ad77-428e-942b-95e82c081a04/documents/499c4cc6-4d1e-4de6-ad84-1803f9432f8f_3dbea803-99e8-4f8d-851b-1e47934eb1df.html,Repeated dose toxicity – local effects,inhalation,NOAEC,10 mg/m3,adverse effect observed,rat Methacrylamide,79-39-0, Acute oral toxicity rat: LD50: 1815 mg/kg; signs of neurotoxicity at the lowest tested doses in the key and supportive study Acute dermal toxicity rat: LD0: > 1600 mg/kg Short-term repeated dose toxicity rat: microscopic signs of respiratory irritation. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34553733-ad77-428e-942b-95e82c081a04/documents/b45c6f31-2612-43bd-b8fd-15fc68146c3f_3dbea803-99e8-4f8d-851b-1e47934eb1df.html,,,,,, Methacrylamide,79-39-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34553733-ad77-428e-942b-95e82c081a04/documents/b45c6f31-2612-43bd-b8fd-15fc68146c3f_3dbea803-99e8-4f8d-851b-1e47934eb1df.html,,oral,LD50,"1,815 mg/kg bw",adverse effect observed, Methacrylamide,79-39-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34553733-ad77-428e-942b-95e82c081a04/documents/b45c6f31-2612-43bd-b8fd-15fc68146c3f_3dbea803-99e8-4f8d-851b-1e47934eb1df.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, (3-methacrylamidopropyl)trimethylammonium chloride,51410-72-1,"Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test; oral (gavage); rat (Sprague Dawley [Crl:CD(SD)BR]), m/f (OECD guideline 422, GLP): NOAEL = 1000 mg/kg bw/d ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20dd0a2a-07ad-40cd-b033-10c8a4ae9fa5/documents/IUC5-3b0a2aeb-b887-450c-a36c-feb7d5fda965_63cc20b7-2d81-442d-8eed-c0ded4d0c3ce.html,,,,,, (3-methacrylamidopropyl)trimethylammonium chloride,51410-72-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20dd0a2a-07ad-40cd-b033-10c8a4ae9fa5/documents/IUC5-3b0a2aeb-b887-450c-a36c-feb7d5fda965_63cc20b7-2d81-442d-8eed-c0ded4d0c3ce.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat (3-methacrylamidopropyl)trimethylammonium chloride,51410-72-1,"Acute oral toxicity: LD50 (rat, males) > 4240 mg a.i./kg bw; equivalent to OECD guideline 401; pre-GLP studyAcute inhalation toxicity: no relevant route of exposureAcute dermal toxicity: LD50 (rat, male/female) > 2000 mg/kg bw; OECD guideline 402; GLP ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20dd0a2a-07ad-40cd-b033-10c8a4ae9fa5/documents/IUC5-89c60830-a6de-4944-8627-79be48fe24dd_63cc20b7-2d81-442d-8eed-c0ded4d0c3ce.html,,,,,, (3-methacrylamidopropyl)trimethylammonium chloride,51410-72-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20dd0a2a-07ad-40cd-b033-10c8a4ae9fa5/documents/IUC5-89c60830-a6de-4944-8627-79be48fe24dd_63cc20b7-2d81-442d-8eed-c0ded4d0c3ce.html,,oral,LD50,"4,240 mg/kg bw",no adverse effect observed, (3-methacrylamidopropyl)trimethylammonium chloride,51410-72-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20dd0a2a-07ad-40cd-b033-10c8a4ae9fa5/documents/IUC5-89c60830-a6de-4944-8627-79be48fe24dd_63cc20b7-2d81-442d-8eed-c0ded4d0c3ce.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-trimethoxysilylpropyl methacrylate,2530-85-0,"There are seven repeated dose inhalation studies (Bushy Run Research Center, 1984, 1994, 1989a, 1991, 1986, 1989b, 1983) which have investigated the potential for the formation of laryngeal granulomas following inhalation exposure to an aerosolised test material, 3-trimethoxysilylpropyl methacrylate (CAS RN: 2530-85-0, EC No. 219-785-8) of varying concentrations, pH and exposure duration. There is an additional 9-day repeated dose inhalation exposure study to a vapour of the test material in rats (Bushy Run Research Center,1982). Most of the studies were non-standard in design with differing levels of detail, analysis, exposure conditions (i.e. pH and concentrations of starting solutions) as well as exposure duration. Apart from a 14-week aerosol inhalation study (Bushy Run Research Center, 1989a) and a 9-day vapour inhalation study (Bushy Run Research Center, 1982), the most significant effect consistently observed in the aerosol inhalation studies (irrespective of exposure period, concentration or pH) was the formation of laryngeal granulomas, a local effect within the respiratory system. Cytoplasmic hyalinisation of the nasal tissue was also reported in some of the studies (Bushy Run Research Center, 1986,1989b,1991,1994a,1984 and 1989a) and the LOAEC for this local finding was 5 mg/m3. However, an independent expert review of these available studies (Regan, 2022; see attachment in Endpoint summary in Section 7.5 for full details), explains that laryngeal granulomas and nasal cytoplasmic hyalinisation are rodent-specific findings, which are not relevant to humans due to differences in anatomical structure and cell types in the affected regions of the respiratory tract. Therefore, for the purposes of human risk characterisation, the local findings in the nasal cavity and larynx are not relevant. With regards to general systemic toxicity, the only consistently significant finding was a reduction in body weight gain (Bushy Run Research Center, 1983, 1994,1986,1989a,1989b and 1994) and as a worst-case interpretation, it is assumed that the body weight effects are not linked to granuloma formation and the lowest available systemic NOAEC of 50 mg/m3 is used as a starting point for risk characterisation for systemic effects following inhalation exposures. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1586ed1-9ea9-47f8-ad75-e55a059b5a32/documents/bc9ffe5b-3372-4f6a-bdc1-7ccc4d62c800_69d546e5-e3fb-420d-8aec-dc2f29b1c18e.html,,,,,, 3-trimethoxysilylpropyl methacrylate,2530-85-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1586ed1-9ea9-47f8-ad75-e55a059b5a32/documents/bc9ffe5b-3372-4f6a-bdc1-7ccc4d62c800_69d546e5-e3fb-420d-8aec-dc2f29b1c18e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,50 mg/m3,,rat 3-trimethoxysilylpropyl methacrylate,2530-85-0,"The key acute oral toxicity study (Dow Corning Corporation, 2001, reliability score 1) for 3-trimethoxysilylpropyl methacrylate (CAS RN: 2530-85-0; EC No. 219-785-8) was conducted according to OECD Test Guideline 423 and in compliance with GLP. It was selected as the most recent study available out of three reliable acute oral tests in rats. The LD50 was concluded to be >2000 mg/kg bw.   The key acute inhalation study (BRRC, 1983, reliability score 2) was conducted according to OECD Test Guideline 403 but not in compliance with GLP. It is the only study available for this endpoint. The concluded LC50 was determined to be >2.28 mg/L (>2280 mg/m3) .   The key acute dermal toxicity study was selected as the most recent, highest reliability study (WIL, 2001a, reliability score 1) conducted according to OECD Test Guideline 402 and in compliance with GLP. An LD50 was determined to be >2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1586ed1-9ea9-47f8-ad75-e55a059b5a32/documents/cdc34571-ad8b-4364-8ce0-69e5d4e85958_69d546e5-e3fb-420d-8aec-dc2f29b1c18e.html,,,,,, 3-trimethoxysilylpropyl methacrylate,2530-85-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1586ed1-9ea9-47f8-ad75-e55a059b5a32/documents/cdc34571-ad8b-4364-8ce0-69e5d4e85958_69d546e5-e3fb-420d-8aec-dc2f29b1c18e.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 3-trimethoxysilylpropyl methacrylate,2530-85-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1586ed1-9ea9-47f8-ad75-e55a059b5a32/documents/cdc34571-ad8b-4364-8ce0-69e5d4e85958_69d546e5-e3fb-420d-8aec-dc2f29b1c18e.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 3-trimethoxysilylpropyl methacrylate,2530-85-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1586ed1-9ea9-47f8-ad75-e55a059b5a32/documents/cdc34571-ad8b-4364-8ce0-69e5d4e85958_69d546e5-e3fb-420d-8aec-dc2f29b1c18e.html,,inhalation,LC50,"> 2,280 mg/m3",no adverse effect observed, "2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, phosphate",52628-03-2," Results of a 28 day oral gavage study are available. Effects were noted in the stomach (considered point of contact irritant effects) and kidney. Results of a 90 day oral gavage study are available. No adverse effects were observed, although male body weight gain was significantly decreased on test day 8. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/348928f5-de6f-45fa-be81-0bfc954971b0/documents/IUC5-20d52a7c-cd48-44b4-9803-f97d5f58a01e_87f9202f-4316-4019-a68a-3f8e6de5c1f7.html,,,,,, "2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, phosphate",52628-03-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/348928f5-de6f-45fa-be81-0bfc954971b0/documents/IUC5-20d52a7c-cd48-44b4-9803-f97d5f58a01e_87f9202f-4316-4019-a68a-3f8e6de5c1f7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, phosphate",52628-03-2,"The acute oral LD50 of the test substance is greater than 2,000 mg/kg of body weight in female rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/348928f5-de6f-45fa-be81-0bfc954971b0/documents/IUC5-9b37cb8b-b552-447c-b1c3-7a198b89e83a_87f9202f-4316-4019-a68a-3f8e6de5c1f7.html,,,,,, 2-isocyanatoethyl methacrylate,30674-80-7,"Oral: no data availableDermal: no data availableInhalation (Similar to OECD TG 413), rat: NOAEL = 1.583 mg/m³ ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3531fda9-9714-4949-93eb-eb2a4cbd168f/documents/IUC5-fed6cd09-0403-4b4d-90a5-25c7926c3404_9b817cf2-3723-41a3-8d26-297ed1b74c73.html,,,,,, 2-isocyanatoethyl methacrylate,30674-80-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3531fda9-9714-4949-93eb-eb2a4cbd168f/documents/IUC5-fed6cd09-0403-4b4d-90a5-25c7926c3404_9b817cf2-3723-41a3-8d26-297ed1b74c73.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,1.583 mg/m3,,rat 2-isocyanatoethyl methacrylate,30674-80-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3531fda9-9714-4949-93eb-eb2a4cbd168f/documents/IUC5-fed6cd09-0403-4b4d-90a5-25c7926c3404_9b817cf2-3723-41a3-8d26-297ed1b74c73.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1.583 mg/m3,no adverse effect observed,rat 2-isocyanatoethyl methacrylate,30674-80-7,"Oral (OECD 401), mouse: LD50=472 mg/kg bw Dermal: Data waiving according to Column 2 of REACH Annex VIII, Section 8.5.2Inhalation (similar to OECD 403), rat, 6h exposure: LC50=28.1 mg/m³ (=0.0281 mg/L) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3531fda9-9714-4949-93eb-eb2a4cbd168f/documents/IUC5-6057932b-af5f-4c61-9238-890fa402f812_9b817cf2-3723-41a3-8d26-297ed1b74c73.html,,,,,, 2-isocyanatoethyl methacrylate,30674-80-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3531fda9-9714-4949-93eb-eb2a4cbd168f/documents/IUC5-6057932b-af5f-4c61-9238-890fa402f812_9b817cf2-3723-41a3-8d26-297ed1b74c73.html,,oral,LD50,472 mg/kg bw,adverse effect observed, 2-isocyanatoethyl methacrylate,30674-80-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3531fda9-9714-4949-93eb-eb2a4cbd168f/documents/IUC5-6057932b-af5f-4c61-9238-890fa402f812_9b817cf2-3723-41a3-8d26-297ed1b74c73.html,,inhalation,LC50,28.1 mg/m3,adverse effect observed, Methenamine,100-97-0," Oral (Animal data): In the key study (Lijinsky, 1977), it was concluded that >= 0.1%methenamine(equivalent to >= 80 mg/kgbw/d in males and >= 100 mg/kgbw/d in females, highest test dose applied) was established as the no-toxic-effect-level (NOAELsys) for Sprague-Dawleyrats. Human Data: Dose level causing no toxic effects in man: 2 to 4 g/d, equivalent to ca. 28 to 57 mg/kgbw/d (Goodman and Gilman, 1975; Martindale, 2005). The NOAEL of 4 g/d (57 mg/kgbw/d based on a body weight of 70 kg person) in man (Goodman and Gilman, 1975; Martindale, 2005) is derived from decades of long experience withmethenamineas a therapeutic substance (Human:NOAELsys: 57 mg/kgbw/d) and used as a reference figure in the risk assessment. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b02991e8-e440-4214-a54a-56a3ff777962/documents/72830adb-47a1-4698-a4af-d7f0795cf304_8b074e42-a978-412f-9de9-95aa49e7fb08.html,,,,,, Methenamine,100-97-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b02991e8-e440-4214-a54a-56a3ff777962/documents/72830adb-47a1-4698-a4af-d7f0795cf304_8b074e42-a978-412f-9de9-95aa49e7fb08.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat Methenamine,100-97-0, The LD50 ofmethenamineis > 20000 mg/kgbwafter single oral administration to rats. The LD50 ofmethenamineafter dermal application in the rats is > 2000 mg/kgbw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b02991e8-e440-4214-a54a-56a3ff777962/documents/6e5b526f-e236-4d3d-a319-0c5d75ff2bed_8b074e42-a978-412f-9de9-95aa49e7fb08.html,,,,,, Methenamine,100-97-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b02991e8-e440-4214-a54a-56a3ff777962/documents/6e5b526f-e236-4d3d-a319-0c5d75ff2bed_8b074e42-a978-412f-9de9-95aa49e7fb08.html,,oral,LD50,"20,000 mg/kg bw",no adverse effect observed, Methenamine,100-97-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b02991e8-e440-4214-a54a-56a3ff777962/documents/6e5b526f-e236-4d3d-a319-0c5d75ff2bed_8b074e42-a978-412f-9de9-95aa49e7fb08.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-(1-methoxy-1-methylethyl)-1-methylcyclohexene,14576-08-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): The 90-day inhalation study may be used for assessing local inhalation toxicity. It should be noted that for local effects the extrapolation from rat to human is generally not justified (CLP, 2015)the repeated dose toxicity. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The subchronic inhalation study is sufficiently reliable (based on read across) and therefore adequate to cover this endpoint. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/844c5a15-fb50-4b31-bb3e-9e28e855914d/documents/IUC5-d93e19ea-910f-45f8-9876-c063e3af85be_b8da1c47-fd99-43e2-abd9-d1f6ea0f0c81.html,,,,,, 4-(1-methoxy-1-methylethyl)-1-methylcyclohexene,14576-08-0,Acute oral toxicity: LD50 > 5000 mg/kg bwAcute inhalation toxicity: Extrapolated from acute oral toxicity LC50 > 13000 mg/m3Acute dermal toxicity: Extrapolation from acute oral toxicity: LD50 > 5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/844c5a15-fb50-4b31-bb3e-9e28e855914d/documents/IUC5-23e95bd5-f967-461a-ab71-9726a4d04d18_b8da1c47-fd99-43e2-abd9-d1f6ea0f0c81.html,,,,,, Methoxycyclododecane,2986-54-1,"Oral (OECD 425), rat: LD50 > 5000 mg/kg bw (limit test)Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c25359f6-05f0-48c7-9fc7-4e6cfdb4917a/documents/IUC5-2f982377-1a2b-4eee-bc83-a8ecd432d23e_e37536f7-bdd0-4f5b-9b03-e0544589f467.html,,,,,, 2-(2-methoxyethoxy)ethanol,111-77-3," ORAL ROUTE: NOAEC (6 week, gavage, rat): 900mg/kg NOAEC (11 day, gavage, rat): 1000mg/kg NOAEC (20 day, gavage, rat): 500-1000mg/kg - biochemical changes NOAEC (20 day, gavage, rat): 500mg/kg (LOAEL=1000mg/kg) DERMAL NOAEL (90 day, rat) = 40mg/kg INHALATION NOAEC>1060mg/m3 (saturated vapour concentration) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9abf89ed-8b9b-4317-afec-3394c891d643/documents/afa22ea1-4feb-4ed8-bbcd-7c9edca43093_ca8dbac3-6e14-48cb-8968-90453f7d9b45.html,,,,,, 2-(2-methoxyethoxy)ethanol,111-77-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9abf89ed-8b9b-4317-afec-3394c891d643/documents/afa22ea1-4feb-4ed8-bbcd-7c9edca43093_ca8dbac3-6e14-48cb-8968-90453f7d9b45.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,900 mg/kg bw/day,, 2-(2-methoxyethoxy)ethanol,111-77-3,"ORAL:Mouse, male: LD50=7128mg/kg (fasted animals), 8188mg/kg (fed animals)Rat, male: LD50=7128mg/kg (fasted animals), 12410mg/kg (fed animals), >5000mg/kgRat, male/female: LD50=9210mg/kg, ~6500mg/kg, 6700ml/kgGuinea pig, male/female: LD50=4160mg/kgCat: LD50>4080mg/kgRabbit; LD50=>4000mg/kg, 6.3g/kgINHALATION:LD50 greater than saturated vapour pressureDERMALRabbit, male: LD50=9404mg/kgRabbit: LD50=8980ml/kg (9284mg/kg)Guinea pig: LD50>10g/kg, LD50 5-8g/kg ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9abf89ed-8b9b-4317-afec-3394c891d643/documents/72c597fe-9250-4397-b113-4ad092a3d166_ca8dbac3-6e14-48cb-8968-90453f7d9b45.html,,,,,, 2-(2-methoxyethoxy)ethanol,111-77-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9abf89ed-8b9b-4317-afec-3394c891d643/documents/72c597fe-9250-4397-b113-4ad092a3d166_ca8dbac3-6e14-48cb-8968-90453f7d9b45.html,,oral,LD50,"4,160 mg/kg bw",, 2-(2-methoxyethoxy)ethanol,111-77-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9abf89ed-8b9b-4317-afec-3394c891d643/documents/72c597fe-9250-4397-b113-4ad092a3d166_ca8dbac3-6e14-48cb-8968-90453f7d9b45.html,,dermal,LD50,"9,284 mg/kg bw",, 2-(2-methoxyethoxy)ethyl methacrylate,45103-58-0," In an oral acute toxicity study according to the current EPA Health Effects Test Guidelines, OCSPP 870.1100, and OECD TG 425 under GLP conditions, the oral LD50 of 2-(2-methoxyethoxy)ethyl methacrylate is greater than 2000 mg/kg  body weight in female Sprague Dawley rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43e688e4-d775-4ec4-940b-f169499e9e5f/documents/33672306-a9a3-4d9f-877b-e2e7570bcbdb_3eb33506-f024-4b6c-a3f4-c1d97d621ea1.html,,,,,, 2-(2-methoxyethoxy)ethyl methacrylate,45103-58-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43e688e4-d775-4ec4-940b-f169499e9e5f/documents/33672306-a9a3-4d9f-877b-e2e7570bcbdb_3eb33506-f024-4b6c-a3f4-c1d97d621ea1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-methoxyethyl acrylate,3121-61-7,"NOAEL (OECD 422, subacute, oral, rat): < 40 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43e8f80f-bdf7-49c0-a745-350f3d0c782e/documents/IUC5-60631da0-2a79-4124-9308-0645f7b67c24_cafe31d8-b4e4-4647-8a37-7750a40224e8.html,,,,,, 2-methoxyethyl acrylate,3121-61-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43e8f80f-bdf7-49c0-a745-350f3d0c782e/documents/IUC5-60631da0-2a79-4124-9308-0645f7b67c24_cafe31d8-b4e4-4647-8a37-7750a40224e8.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,40 mg/kg bw/day,,rat 2-methoxyethyl acrylate,3121-61-7,"Oral (comparable to OECD 401), rat: LD50= 404 mg/kg bw Inhalation (comparable to OECD 403), rat, 4 h exposure: LC50 = 2.7 mg/L Dermal (comparable to OECD 402), rabbit: LD50 = 252.5 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43e8f80f-bdf7-49c0-a745-350f3d0c782e/documents/IUC5-42c78edf-ea7c-45b7-9205-21f9d7405888_cafe31d8-b4e4-4647-8a37-7750a40224e8.html,,,,,, 2-methoxyethyl acrylate,3121-61-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43e8f80f-bdf7-49c0-a745-350f3d0c782e/documents/IUC5-42c78edf-ea7c-45b7-9205-21f9d7405888_cafe31d8-b4e4-4647-8a37-7750a40224e8.html,,oral,LD50,404 mg/kg bw,adverse effect observed, 2-methoxyethyl acrylate,3121-61-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43e8f80f-bdf7-49c0-a745-350f3d0c782e/documents/IUC5-42c78edf-ea7c-45b7-9205-21f9d7405888_cafe31d8-b4e4-4647-8a37-7750a40224e8.html,,dermal,LD50,252.5 mg/kg bw,adverse effect observed, 2-methoxyethyl acrylate,3121-61-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43e8f80f-bdf7-49c0-a745-350f3d0c782e/documents/IUC5-42c78edf-ea7c-45b7-9205-21f9d7405888_cafe31d8-b4e4-4647-8a37-7750a40224e8.html,,inhalation,LC50,"2,700 mg/m3",adverse effect observed, 2-methoxyethyl 2-cyanoacrylate,27816-23-5,"A study on repeated toxicity is waived due to high reactivity of 2-methoxyethyl 2-cyanoacrylate which makes testing not feasible. On contact with moisture, 2-methoxyethyl 2-cyanoacrylate polymerizes immediately. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07f11961-6dd7-4957-8047-95a8d9f39051/documents/IUC5-0efd5ad6-d49b-4477-8aa9-79dba8f377de_ee79810f-0a0a-4191-a6dd-54da9fce23e0.html,,,,,, 2-methoxyethyl 2-cyanoacrylate,27816-23-5,"Test not performed because 2-methoxyethyl 2-cyanoacrylate is highly reactive to water resulting in fast polymerization process (in seconds) thus the nature of the substance does not allow to be tested for the endpoint Acute Toxicity (Annex XI, section 2). As it is described in the Guidance on information requirements and chemical safety assessment Chapter R.5: Adaptation of information requirements chapter (R.5.2.2 Testing is technically not possible (page 28)) the waiver is herewith justified. Thus, our waiver is based on following argumentation:  1. testing is technically not possible and 2. the exposure to the 2-methoxyethyl 2-cyanoacrylate monomer plays a minor role or is unlikely. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07f11961-6dd7-4957-8047-95a8d9f39051/documents/IUC5-6b9dfb1e-01e0-4c62-a791-7ffa75181efa_ee79810f-0a0a-4191-a6dd-54da9fce23e0.html,,,,,, 3-(p-methoxyphenyl)-2-methylpropionaldehyde,5462-06-6, A study in accordance with OECD TG 422 reveals a NOAEL for systemic effects of 129.7 mg/kg bw/day for males and 161.4 mg/kg bw/day for females. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fff5202c-3afc-42f6-895c-8962f4af84cf/documents/43151a4a-8b81-4cb3-9181-73fd43848877_613074fa-8166-4063-b180-3aee1a015e0d.html,,,,,, 3-(p-methoxyphenyl)-2-methylpropionaldehyde,5462-06-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fff5202c-3afc-42f6-895c-8962f4af84cf/documents/43151a4a-8b81-4cb3-9181-73fd43848877_613074fa-8166-4063-b180-3aee1a015e0d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,129.7 mg/kg bw/day,,rat 3-(p-methoxyphenyl)-2-methylpropionaldehyde,5462-06-6," Acute oral toxicity: a study similar to OECDTG401: LD50 = 4000 mg/kg bw Acute inhalation toxicity LC50 route to route extrapolation = 10400 mg/m3 being higher than 1910 mg/m3, which is the saturated vapour concentration of Canthoxal Acute dermal toxicity: a study similar to OECDTG402: LD50 => 5000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fff5202c-3afc-42f6-895c-8962f4af84cf/documents/df6eb509-1a88-4e3e-af08-998545e1002f_613074fa-8166-4063-b180-3aee1a015e0d.html,,,,,, 1-methoxypropan-2-ol,107-98-2,"Four studies were performed to assess the repeated dose toxicity properties of propylene glycol methyl ether by oral route. None was conducted according to GLP and guidelines. For dermal exposure, a GLP-study equivalent to OECD guideline 410 is available for propylene glycol methyl ether. This study is supported by two non-GLP studies similar to OECD guideline 411. Numerous GLP and non-GLP studies are available for repeated inhalation exposure to propylene glycol methyl ether according or equivalent to OECD guidelines 412, 413 and 453. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c83efb4-16a5-4b08-b007-6b8415f2492e/documents/IUC5-f6257096-eaa2-45e3-9cad-a2306a2e45d9_84de6133-ae16-4262-bc44-2dfc41cf61df.html,,,,,, 1-methoxypropan-2-ol,107-98-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c83efb4-16a5-4b08-b007-6b8415f2492e/documents/IUC5-f6257096-eaa2-45e3-9cad-a2306a2e45d9_84de6133-ae16-4262-bc44-2dfc41cf61df.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,460 mg/kg bw/day,,rat 1-methoxypropan-2-ol,107-98-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c83efb4-16a5-4b08-b007-6b8415f2492e/documents/IUC5-f6257096-eaa2-45e3-9cad-a2306a2e45d9_84de6133-ae16-4262-bc44-2dfc41cf61df.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,840 mg/kg bw/day",,rabbit 1-methoxypropan-2-ol,107-98-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c83efb4-16a5-4b08-b007-6b8415f2492e/documents/IUC5-f6257096-eaa2-45e3-9cad-a2306a2e45d9_84de6133-ae16-4262-bc44-2dfc41cf61df.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,122 mg/m3",,rat 1-methoxypropan-2-ol,107-98-2,"GLP guideline studies for acute toxicity via oral, dermal and inhalation exposure are available for propylene glycol methyl ether. These studies are supported by several non-GLP studies equivalent or similar to OECD guidelines 401, 402 and 403. The studies rated as Klimisch 1 (reliable without restrictions) have been selected as as key studies for the hazard assessment. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c83efb4-16a5-4b08-b007-6b8415f2492e/documents/IUC5-464bc26f-00b4-4b55-b9dd-d8bdee26e6ad_84de6133-ae16-4262-bc44-2dfc41cf61df.html,,,,,, 1-methoxypropan-2-ol,107-98-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c83efb4-16a5-4b08-b007-6b8415f2492e/documents/IUC5-464bc26f-00b4-4b55-b9dd-d8bdee26e6ad_84de6133-ae16-4262-bc44-2dfc41cf61df.html,,oral,LD50,"4,016 mg/kg bw",adverse effect observed, 2-methoxy-1-methylethyl acetate,108-65-6,"For the oral route, an OECD 422 study (GLP) is available for propylene glycol methyl ether acetate. The study has been conducted by the Japanese Ministry of Health. The full test report is not available, but it was validated by the Japanese authorities within the OECD SIDS activities. For the dermal route, no studies are available for propylene glycol methyl ether acetate. Therefore, read-across from dermal studies with propylene glycol methyl ether was done. A 13-week repeated-dose dermal toxicity study in rabbits was selected as the most relevant study for the risk assessment. For the inhalation route, only short-term (9-day exposure) studies are available for propylene glycol methyl ether acetate. Therefore, read-across from 90-day and 2-year inhalation toxicity studies with propylene glycol methyl ether was used. See attached category document in Section 13 for read-across justification. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0a86dab-5f7a-4eb0-92df-856b85886191/documents/IUC5-3914bee0-e236-48b3-9b14-965baaa09dc6_8c7a2e82-0fde-4c69-a0a6-2f0ae26169b6.html,,,,,, 2-methoxy-1-methylethyl acetate,108-65-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0a86dab-5f7a-4eb0-92df-856b85886191/documents/IUC5-3914bee0-e236-48b3-9b14-965baaa09dc6_8c7a2e82-0fde-4c69-a0a6-2f0ae26169b6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-methoxy-1-methylethyl acetate,108-65-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0a86dab-5f7a-4eb0-92df-856b85886191/documents/IUC5-3914bee0-e236-48b3-9b14-965baaa09dc6_8c7a2e82-0fde-4c69-a0a6-2f0ae26169b6.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,650 mg/m3",,rat 2-methoxy-1-methylethyl acetate,108-65-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0a86dab-5f7a-4eb0-92df-856b85886191/documents/IUC5-3914bee0-e236-48b3-9b14-965baaa09dc6_8c7a2e82-0fde-4c69-a0a6-2f0ae26169b6.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,675 mg/kg bw/day",,rabbit 2-methoxy-1-methylethyl acetate,108-65-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0a86dab-5f7a-4eb0-92df-856b85886191/documents/IUC5-3914bee0-e236-48b3-9b14-965baaa09dc6_8c7a2e82-0fde-4c69-a0a6-2f0ae26169b6.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"1,650 mg/m3",adverse effect observed,rat 2-methoxy-1-methylethyl acetate,108-65-6,"Several acute toxicity studies in rats and mice are available for the oral, dermal and inhalation route. Most studies were not conducted under GLP and or/to OECD guidelines, but were conducted equivalent to OECD guidelines 401, 402 and 403, and therefore have been considered to be valid. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0a86dab-5f7a-4eb0-92df-856b85886191/documents/IUC5-d2c02f06-4736-4960-8536-b10d96d3d012_8c7a2e82-0fde-4c69-a0a6-2f0ae26169b6.html,,,,,, 2-methoxy-1-methylethyl acetate,108-65-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0a86dab-5f7a-4eb0-92df-856b85886191/documents/IUC5-d2c02f06-4736-4960-8536-b10d96d3d012_8c7a2e82-0fde-4c69-a0a6-2f0ae26169b6.html,,oral,LD50,"6,190 mg/kg bw",adverse effect observed, 3-methoxy-3-methylbutan-1-ol,56539-66-3,"A 28-day repeated dose study and a 90-day repeated dose study in rats with expsoure via the oral route are available. Both studies are reliable (Klimisch 1 studies). In addition, a 28-day repeated dose study (Klimisch 2 study, study only included males) and a 90-day study (Klimisch 1 study) via the inhalation route are available. No data are available for repeated exposure via the dermal route.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): A reliable sub-chronic study is available (Klimisch 1). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Two reliable studies are available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0042d393-a722-4d58-9a1b-e11a4e99990c/documents/IUC5-24454cfb-07d9-4369-8372-28b4cd66e584_236e9996-287f-498b-8c09-2619c1a7d058.html,,,,,, 3-methoxy-3-methylbutan-1-ol,56539-66-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0042d393-a722-4d58-9a1b-e11a4e99990c/documents/IUC5-24454cfb-07d9-4369-8372-28b4cd66e584_236e9996-287f-498b-8c09-2619c1a7d058.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 3-methoxy-3-methylbutan-1-ol,56539-66-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0042d393-a722-4d58-9a1b-e11a4e99990c/documents/IUC5-24454cfb-07d9-4369-8372-28b4cd66e584_236e9996-287f-498b-8c09-2619c1a7d058.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,2 mg/L,,rat 3-methoxy-3-methylbutan-1-ol,56539-66-3,"3-Methoxy-3-methyl-1-butanol has a low acute toxicity by oral, inhalation and dermal routes. In rats, the LD50 value via the oral route is > 4000 mg/kg bw. In an acute dermal toxicity study with rabbits, the LD50 was > 2000 mg/kg bw. In an acute inhalation study, the LC50 of MMB was concluded to exceed 5 mg/L. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable studies available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): One reliable study available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): One reliable study available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0042d393-a722-4d58-9a1b-e11a4e99990c/documents/IUC5-420d4063-9e48-4355-9a54-9b05a5d48ceb_236e9996-287f-498b-8c09-2619c1a7d058.html,,,,,, 3-methoxy-3-methylbutan-1-ol,56539-66-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0042d393-a722-4d58-9a1b-e11a4e99990c/documents/IUC5-420d4063-9e48-4355-9a54-9b05a5d48ceb_236e9996-287f-498b-8c09-2619c1a7d058.html,,oral,LD50,"4,300 mg/kg bw",adverse effect observed, 3-methoxy-3-methylbutan-1-ol,56539-66-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0042d393-a722-4d58-9a1b-e11a4e99990c/documents/IUC5-420d4063-9e48-4355-9a54-9b05a5d48ceb_236e9996-287f-498b-8c09-2619c1a7d058.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 3-methoxy-3-methylbutan-1-ol,56539-66-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0042d393-a722-4d58-9a1b-e11a4e99990c/documents/IUC5-420d4063-9e48-4355-9a54-9b05a5d48ceb_236e9996-287f-498b-8c09-2619c1a7d058.html,,inhalation,LC50,> 5 mg/L,no adverse effect observed, "1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol",955359-35-0," No test for acute oral toxicity is available for Avodiol. However, an oral LD50 value of >16000 mg/kg bw in the rat is available for a structurally similar compound. Therefore, based on this read-across, it can be concluded that the oral LD50 value of Avodiol is > 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c90d3e93-68db-4f70-81c1-3e1b6bb1883e/documents/4bb22a09-3683-4e30-b534-cb1093f9f049_7026f0f2-1e71-41af-949a-98d5118509c5.html,,,,,, "1-(4-tert-Butyl-phenyl)-3-(4-methoxy-phenyl)-propane-1,3-diol",955359-35-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c90d3e93-68db-4f70-81c1-3e1b6bb1883e/documents/4bb22a09-3683-4e30-b534-cb1093f9f049_7026f0f2-1e71-41af-949a-98d5118509c5.html,,oral,LD50,"16,000 mg/kg bw",no adverse effect observed, 4-(4-methoxyphenyl)butan-2-one,104-20-1, The NOAEL for systemic toxicity was found to be 500 mg/kg/day in rats of both sexes upon oral administration of the test item. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d2d64e4-07fe-4493-9a79-d0c25cd48938/documents/d5fe37aa-f9d9-46e5-8588-5bb94bdf2aef_e7c8348e-35da-4921-a5ba-903d649c3648.html,,,,,, 4-(4-methoxyphenyl)butan-2-one,104-20-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d2d64e4-07fe-4493-9a79-d0c25cd48938/documents/d5fe37aa-f9d9-46e5-8588-5bb94bdf2aef_e7c8348e-35da-4921-a5ba-903d649c3648.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat 4-(4-methoxyphenyl)butan-2-one,104-20-1, The substance was found to not cause mortality in a recent acute oral toxicity test in accordance with OECD and GLP guidelines. Additional inhalation and dermal acute toxicity testing is not deemed to be needed. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d2d64e4-07fe-4493-9a79-d0c25cd48938/documents/b5ac5321-77bb-473a-aa88-25b9ed134218_e7c8348e-35da-4921-a5ba-903d649c3648.html,,,,,, 4-(4-methoxyphenyl)butan-2-one,104-20-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d2d64e4-07fe-4493-9a79-d0c25cd48938/documents/b5ac5321-77bb-473a-aa88-25b9ed134218_e7c8348e-35da-4921-a5ba-903d649c3648.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-ethoxyethyl (2Z)-2-cyano-2-[3-(3-methoxypropylamino)cyclohex-2-en-1-ylidene]acetate,1419401-88-9,"The 90-days oral toxicity study (OECD 408, GLP) with the test item (CAS 1419401-88-9) a NOAEL of 300 mg/kg bw/day was determined in the rat. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0cd259d-9024-4445-99f3-a2da6220dd60/documents/IUC5-56210101-4656-4ec9-8855-5cee79c1ecaf_da476862-8dcf-439e-aef8-0624da8475a8.html,,,,,, 2-ethoxyethyl (2Z)-2-cyano-2-[3-(3-methoxypropylamino)cyclohex-2-en-1-ylidene]acetate,1419401-88-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0cd259d-9024-4445-99f3-a2da6220dd60/documents/IUC5-56210101-4656-4ec9-8855-5cee79c1ecaf_da476862-8dcf-439e-aef8-0624da8475a8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 2-ethoxyethyl (2Z)-2-cyano-2-[3-(3-methoxypropylamino)cyclohex-2-en-1-ylidene]acetate,1419401-88-9,"No mortality was observed in an acute oral toxicity study with the structural surrogate FAT 75´819/A when female rats were administered up to 2000 mg/kg bw. In line, no mortality occurred in rats after oral gavage treatment with 2-ethoxyethyl (2Z)-2-cyano-2-[3-(3-methoxypropylamino)cyclohex-2-en-1-ylidene]acetate (CAS 1419401-88-9) both in a 90-day repeated dose toxicity study at up to 1000 mg/kg bw/day and in a micronucleus test after two-fold adminstration of up to 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0cd259d-9024-4445-99f3-a2da6220dd60/documents/IUC5-cf6cebcb-3b36-413b-8520-08e5ec6f827e_da476862-8dcf-439e-aef8-0624da8475a8.html,,,,,, "Methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate",28043-10-9," Oral: LD50 = 4100 mg/kg bw, male/female rat, equiv. to OECD 401, 1981 Dermal: LD50 = > 2000 mg/kg bw, male/female rabbit, equiv. to OECD 402, 1981 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f66415d8-323c-4056-941f-e8c1696df70d/documents/IUC5-887126fc-ff88-456f-8402-887a970b141c_65771462-3088-4582-b76f-b6e89e65166a.html,,,,,, "Methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate",28043-10-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f66415d8-323c-4056-941f-e8c1696df70d/documents/IUC5-887126fc-ff88-456f-8402-887a970b141c_65771462-3088-4582-b76f-b6e89e65166a.html,,oral,LD50,"4,100 mg/kg bw",no adverse effect observed, "Methyl 2,6,6-trimethylcyclohex-2-ene-1-carboxylate",28043-10-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f66415d8-323c-4056-941f-e8c1696df70d/documents/IUC5-887126fc-ff88-456f-8402-887a970b141c_65771462-3088-4582-b76f-b6e89e65166a.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Methyl abietate,127-25-3, Acute oral toxicity LD50 was estimated to be 2511.54mg/kg bw when rats were exposed with Methyl abietate(127-25-3) orally. Acute dermal toxicity LD50 was estimated to be 5665.74mg/kg bw when rabbits were exposed with Methyl abietate(127-25-3) by dermal application. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e844817a-525d-4027-b838-22c70ed8e542/documents/9d013c93-4ec5-4b18-86b3-91dd38be5afd_d847ff8f-a6d0-4d9c-b603-60df9500ec00.html,,,,,, Methyl abietate,127-25-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e844817a-525d-4027-b838-22c70ed8e542/documents/9d013c93-4ec5-4b18-86b3-91dd38be5afd_d847ff8f-a6d0-4d9c-b603-60df9500ec00.html,,oral,LD50,"2,511.54 mg/kg bw",no adverse effect observed, Methyl abietate,127-25-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e844817a-525d-4027-b838-22c70ed8e542/documents/9d013c93-4ec5-4b18-86b3-91dd38be5afd_d847ff8f-a6d0-4d9c-b603-60df9500ec00.html,,dermal,LD50,"5,665.74 mg/kg bw",no adverse effect observed, Methyl acetate,79-20-9," The likely route of human exposure is inhalation. In a OECD guideline 412, rats (Hsd: Sprague Dawley SD; 10/sex/group) were exposed nose-only to concentrations of methyl acetate (purity: >99.5%) of 0, 79, 335, and 2018 ppm (analytical concentrations: 0, 244, 1035, and 6236 mg/m3), 6 hours/day, 5 days/week, for 28 days (Hoechst AG 1999). No compound-related mortality or clinical signs (including neurological disturbances) were seen in any of the exposed groups in the main study. In the high-concentration group, a moderately, statistically significantly decreased body weights (by 10%) and food consumption was observed. As a consequence absolute and relative organ weights were reduced. There were significant changes in blood parameters, clinical chemistry, and urinalysis in the high dose group. Apart from, mostly moderate, degeneration and necrosis of the olfactory epithelium in 19/20 animals of the high-concentration group (2018 ppm;6236 mg/m³), no abnormalities were seen in any other organ or organ system in any other group upon macroscopic and microscopic examination. A NOAEC of 335 ppm (1057 mg/m³) was found in this 28-day inhalation rat study. According to Column 2 Chapter 8.6.2 Annex IX a 90 day subchronic toxicity study does not need to be conducted if the substance undergoes  immediate  disintegration  and  there  are  sufficient  data  on  the  cleavage  products  (both  for  systemic  effects  and  effects  at  the  site  of  uptake). Methyl acetate is rapidly hydrolysed after uptake into methanol and acetic acid as discussed in chapter 7.1 Toxicokinetics.  Both substances are intensively examined and their handling has a longterm human experience including the availability of OELs in most countries. Additionally, acetic acid enters the natural pathway in humans. The local irritancy effects observed in the 28 day study according to OECD 412 sufficiently charcterize the hazard level and a subchronic study is considered as scientifically unnecessary. OELs for methylacetat and methanol by the German MAK Comisson (see DNEL section) can be used for the risk assessment. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab2b825a-6107-4812-b939-4715724d3835/documents/IUC5-11c3e636-e658-4522-b193-4f848c6c0398_312519ff-5c51-4a28-896d-20b4051d5aa6.html,,,,,, Methyl acetate,79-20-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab2b825a-6107-4812-b939-4715724d3835/documents/IUC5-11c3e636-e658-4522-b193-4f848c6c0398_312519ff-5c51-4a28-896d-20b4051d5aa6.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,057 mg/m3",,rat Methyl acetate,79-20-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab2b825a-6107-4812-b939-4715724d3835/documents/IUC5-11c3e636-e658-4522-b193-4f848c6c0398_312519ff-5c51-4a28-896d-20b4051d5aa6.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,057 mg/m3",adverse effect observed,rat Methyl acetate,79-20-9,Oral route: LD 50 = 6482 mg/kg (rats)Dermal route: LD50 > 2000 mg/kg bw (rats)Inhalative route: LC50 >49.2 mg/L ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab2b825a-6107-4812-b939-4715724d3835/documents/IUC5-00549043-332c-45f7-8742-42a1722eb684_312519ff-5c51-4a28-896d-20b4051d5aa6.html,,,,,, Methyl acetate,79-20-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab2b825a-6107-4812-b939-4715724d3835/documents/IUC5-00549043-332c-45f7-8742-42a1722eb684_312519ff-5c51-4a28-896d-20b4051d5aa6.html,,oral,LD50,"6,482 mg/kg bw",adverse effect observed, Methyl acetate,79-20-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab2b825a-6107-4812-b939-4715724d3835/documents/IUC5-00549043-332c-45f7-8742-42a1722eb684_312519ff-5c51-4a28-896d-20b4051d5aa6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl acetate,79-20-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab2b825a-6107-4812-b939-4715724d3835/documents/IUC5-00549043-332c-45f7-8742-42a1722eb684_312519ff-5c51-4a28-896d-20b4051d5aa6.html,,inhalation,LC50,"49,200 mg/m3",no adverse effect observed, Methanol,67-56-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cda9f272-bca1-4de5-b894-80783369405c/documents/IUC5-42d2ba44-2411-4174-adc7-87fb646de85c_2e7da190-5b6f-42aa-8d6a-429d34a9e7b3.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,"2,340 mg/kg bw/day",,monkey Methanol,67-56-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cda9f272-bca1-4de5-b894-80783369405c/documents/IUC5-42d2ba44-2411-4174-adc7-87fb646de85c_2e7da190-5b6f-42aa-8d6a-429d34a9e7b3.html,Chronic toxicity – systemic effects,inhalation,NOAEC,13 mg/m3,,monkey Methanol,67-56-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cda9f272-bca1-4de5-b894-80783369405c/documents/IUC5-8cc836e3-a3a6-4896-b4d3-c3b36b420282_2e7da190-5b6f-42aa-8d6a-429d34a9e7b3.html,,oral,LD50,"1,187 mg/kg bw",adverse effect observed, Methanol,67-56-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cda9f272-bca1-4de5-b894-80783369405c/documents/IUC5-8cc836e3-a3a6-4896-b4d3-c3b36b420282_2e7da190-5b6f-42aa-8d6a-429d34a9e7b3.html,,dermal,LD50,"17,100 mg/kg bw",adverse effect observed, Methanol,67-56-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cda9f272-bca1-4de5-b894-80783369405c/documents/IUC5-8cc836e3-a3a6-4896-b4d3-c3b36b420282_2e7da190-5b6f-42aa-8d6a-429d34a9e7b3.html,,inhalation,LC50,"43,700 mg/m3",adverse effect observed, Heptan-2-one,110-43-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8479a8a9-a7c9-46d7-9793-d98d999ab7d3/documents/IUC5-0eb8bfc1-bcf8-4fcf-bd66-d27073be4e87_f07712a2-230a-4117-bd54-1f52e9c010da.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Heptan-2-one,110-43-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8479a8a9-a7c9-46d7-9793-d98d999ab7d3/documents/IUC5-0eb8bfc1-bcf8-4fcf-bd66-d27073be4e87_f07712a2-230a-4117-bd54-1f52e9c010da.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"4,787 mg/m3",,monkey Heptan-2-one,110-43-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8479a8a9-a7c9-46d7-9793-d98d999ab7d3/documents/IUC5-89285f17-874e-474e-a95b-ad715e7074c0_f07712a2-230a-4117-bd54-1f52e9c010da.html,,oral,LD50,"1,500 mg/kg bw",, Heptan-2-one,110-43-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8479a8a9-a7c9-46d7-9793-d98d999ab7d3/documents/IUC5-89285f17-874e-474e-a95b-ad715e7074c0_f07712a2-230a-4117-bd54-1f52e9c010da.html,,dermal,LD50,"2,000 mg/kg bw",, Heptan-2-one,110-43-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8479a8a9-a7c9-46d7-9793-d98d999ab7d3/documents/IUC5-89285f17-874e-474e-a95b-ad715e7074c0_f07712a2-230a-4117-bd54-1f52e9c010da.html,,inhalation,LC50,"17,600 mg/m3",, Methyl anthranilate,134-20-3," Repeated Dose Toxicity Study (Oral): No Observed Adverse Effect Level (NOAEL) is considered to be 500 mg / kg body weight when male and female rats were orally treated with test substance for chronic study. Repeated Dose Toxicity Study (Dermal): The acute toxicity value for the test chemical (as provided in section 7.2.3) is >5000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that the test chemical  shall not exhibit  toxicity by the dermal route after repeated exposure. In addition, there is no data available that suggests that the test chemical would exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. Repeated Dose Toxicity Study (Inhalation): The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to low vapour pressure of the test chemical, which is reported to be 1.599 Pa (0.012 mmHg). Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/627107ae-343f-4d34-bb45-040ec37d65a1/documents/343947ee-317f-4d2e-a99d-f7c50c1b3eb2_0bb8850b-0c2c-4cf0-beca-8201b3fa7a12.html,,,,,, Methyl anthranilate,134-20-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/627107ae-343f-4d34-bb45-040ec37d65a1/documents/343947ee-317f-4d2e-a99d-f7c50c1b3eb2_0bb8850b-0c2c-4cf0-beca-8201b3fa7a12.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Methyl anthranilate,134-20-3," Acute oral toxicity: An acute oral toxicity study was carried out on rats to determine the toxic nature of test chemical.50% mortality was observed at a dose level of 2800 mg/kg bw with 95% confidence limit of 2300 to 3300 mg/kg bw. Thus, the LD50 value was >2000 mg/kg bw indicating that the test chemical is not toxic to rats when administered orally and can be classified under the category ‘Not classified’. Acute inhalation toxicity: An acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 1.599 Pa (0.012 mmHg). Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. Acute dermal toxicity: An acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is >5000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/627107ae-343f-4d34-bb45-040ec37d65a1/documents/48222170-570a-4604-87a6-535829a02140_0bb8850b-0c2c-4cf0-beca-8201b3fa7a12.html,,,,,, Methyl anthranilate,134-20-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/627107ae-343f-4d34-bb45-040ec37d65a1/documents/48222170-570a-4604-87a6-535829a02140_0bb8850b-0c2c-4cf0-beca-8201b3fa7a12.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl anthranilate,134-20-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/627107ae-343f-4d34-bb45-040ec37d65a1/documents/48222170-570a-4604-87a6-535829a02140_0bb8850b-0c2c-4cf0-beca-8201b3fa7a12.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Methyl benzoate,93-58-3,"Methyl benzoate is not classified for specific target organ toxicity, since the available studies show the potential toxicity above the guidance values (specific target organ toxicity - repeated exposure). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5f90c6c-caa9-45c8-ae8e-1dfc4bf022c4/documents/6d7fb5eb-652b-4038-b6fe-7dac21bf44cd_98157c62-bd80-4038-8c08-3408eccd78c3.html,,,,,, Methyl benzoate,93-58-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5f90c6c-caa9-45c8-ae8e-1dfc4bf022c4/documents/6d7fb5eb-652b-4038-b6fe-7dac21bf44cd_98157c62-bd80-4038-8c08-3408eccd78c3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Methyl benzoate,93-58-3,Oral: LD50 = 1625 mg/kg body weight leading to classification as Acute Toxicity Hazard Category 4 according to CLPDermal: LD50 > 2000 mg/kg body weight leading to no classification according to CLPInhalation: no information available Value used for CSA:Acute oral toxicity:adverse effect observed(LD50) 1625 mg/kg bw Acute dermal toxicity:no adverse effect observed(LD50) >2000 mg/kg bwAcute inhalation toxicity:no study availableRelevant studies: Key_acute toxicity: oral_1985_ Rel 2Relevant studies: Key_acute toxicity: dermal_1995_Rel 1 ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5f90c6c-caa9-45c8-ae8e-1dfc4bf022c4/documents/66b33683-2203-42b4-81b0-ca78b2bd8d88_98157c62-bd80-4038-8c08-3408eccd78c3.html,,,,,, Methyl benzoate,93-58-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5f90c6c-caa9-45c8-ae8e-1dfc4bf022c4/documents/66b33683-2203-42b4-81b0-ca78b2bd8d88_98157c62-bd80-4038-8c08-3408eccd78c3.html,,oral,LD50,"1,625 mg/kg bw",adverse effect observed, Methyl benzoate,93-58-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5f90c6c-caa9-45c8-ae8e-1dfc4bf022c4/documents/66b33683-2203-42b4-81b0-ca78b2bd8d88_98157c62-bd80-4038-8c08-3408eccd78c3.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "7-methyl-2H-benzo-1,5-dioxepin-3(4H)-one",28940-11-6," Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test: NOAEL = 887 mg/kg bw/day in female rats; NOAEL = 791 mg/kg bw/day in male rats (OECD 422, GLP, K, rel.1). No adverse effect reported at the highest dose level tested in this study. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aed7684d-de50-4761-89a1-bca6e77d1c86/documents/379c8b26-e3c8-4b1a-9893-7e3a0d0da15a_16f8bdb2-ff91-4270-8d1d-00b8e11d086a.html,,,,,, "7-methyl-2H-benzo-1,5-dioxepin-3(4H)-one",28940-11-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aed7684d-de50-4761-89a1-bca6e77d1c86/documents/379c8b26-e3c8-4b1a-9893-7e3a0d0da15a_16f8bdb2-ff91-4270-8d1d-00b8e11d086a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,791 mg/kg bw/day,,rat "7-methyl-2H-benzo-1,5-dioxepin-3(4H)-one",28940-11-6,"Acute toxicity: oral: Rat LD50 (female) > 2000 mg/kg bw (OECD 420, GLP, K, rel. 1)Acute toxicity: dermal: waiver (the substance is corrosive to the skin)Acute toxicity: inhalation: waiver (the substance is corrosive to the skin) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aed7684d-de50-4761-89a1-bca6e77d1c86/documents/IUC5-234de770-554d-44f8-849f-da9baffe4056_16f8bdb2-ff91-4270-8d1d-00b8e11d086a.html,,,,,, "7-methyl-2H-benzo-1,5-dioxepin-3(4H)-one",28940-11-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aed7684d-de50-4761-89a1-bca6e77d1c86/documents/IUC5-234de770-554d-44f8-849f-da9baffe4056_16f8bdb2-ff91-4270-8d1d-00b8e11d086a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl benzoylformate,15206-55-0, Key study carried out according to guideline and with GLP compliance. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cbba4a8-65df-4a58-b346-a0596147e998/documents/IUC5-36e3f097-5c15-4ec7-8a0b-9e8728da8f71_a49cb593-2e68-4891-a190-ab169148d4f8.html,,,,,, Methyl benzoylformate,15206-55-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cbba4a8-65df-4a58-b346-a0596147e998/documents/IUC5-36e3f097-5c15-4ec7-8a0b-9e8728da8f71_a49cb593-2e68-4891-a190-ab169148d4f8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Methyl benzoylformate,15206-55-0," All key information presented in this section was conducted to (or is considered equivalent to) international testing guidelines. GLP certification is appropriate to the age of the studies and the testing dates. Acute toxicity: inhalation Data waiving, exposure considerations.  The study need not be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles of an inhalable size. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cbba4a8-65df-4a58-b346-a0596147e998/documents/IUC5-c715d8e5-a9c3-4fd3-8285-57331a70b4ed_a49cb593-2e68-4891-a190-ab169148d4f8.html,,,,,, Methyl benzoylformate,15206-55-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cbba4a8-65df-4a58-b346-a0596147e998/documents/IUC5-c715d8e5-a9c3-4fd3-8285-57331a70b4ed_a49cb593-2e68-4891-a190-ab169148d4f8.html,,oral,LD50,"6,800 mg/kg bw",no adverse effect observed, Methyl benzoylformate,15206-55-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cbba4a8-65df-4a58-b346-a0596147e998/documents/IUC5-c715d8e5-a9c3-4fd3-8285-57331a70b4ed_a49cb593-2e68-4891-a190-ab169148d4f8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl 2-naphthyl ether,93-04-9," Repeated Dose (Oral) Toxicity: Based on all the available data, it was concluded that the test chemical did not cause any toxicity to any organs when exposed to the test animals in sub-acute and sub-chronic durations via oral route. Therefore, it was concluded that the test chemical was not likely to be classified under category STOT-RE 1 or 2 as per the CLP criteria of classification and labeling. Repeated Dose (Inhalation) Toxicity: The particle size distribution of the substance methyl 2-naphthyl ether was found to vary in the size of 150 µm to 2000 µm,so the potential for the generation of inhalable vapours of methyl 2-naphthyl ether is low. Moreover the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur and therefore repeated dose toxicity via the inhalation route was considered for waiver. Repeated Dose (Dermal) Toxicity: The acute toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that the test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that the test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91e3f21a-2bb1-43a2-a2b9-7e28d6264b62/documents/ab678699-e449-42fc-90bf-50481162b951_d8c164be-03b1-4056-9ddc-a7033f19b82c.html,,,,,, Methyl 2-naphthyl ether,93-04-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91e3f21a-2bb1-43a2-a2b9-7e28d6264b62/documents/ab678699-e449-42fc-90bf-50481162b951_d8c164be-03b1-4056-9ddc-a7033f19b82c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Methyl 2-naphthyl ether,93-04-9," Acute oral toxicity The LD50 value was considered to be >2000 mg/kg bw. When female Wistar rats were treated with test chemical orally. Acute inhalation toxicity The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account the low vapour  pressure of the test substance, which is reported as 0.0082281755  mm Hg. Thus, exposure to inhalable dust,  mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver Acute dermal toxicity The  LD50 value was considered to be >2000 mg/kg bw. When male and female wistar rats were treated with test chemical by dermal application . ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91e3f21a-2bb1-43a2-a2b9-7e28d6264b62/documents/fa7e3c60-08be-490e-b5a1-df65c01a8b4b_d8c164be-03b1-4056-9ddc-a7033f19b82c.html,,,,,, Methyl 2-naphthyl ether,93-04-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91e3f21a-2bb1-43a2-a2b9-7e28d6264b62/documents/fa7e3c60-08be-490e-b5a1-df65c01a8b4b_d8c164be-03b1-4056-9ddc-a7033f19b82c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl 2-naphthyl ether,93-04-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91e3f21a-2bb1-43a2-a2b9-7e28d6264b62/documents/fa7e3c60-08be-490e-b5a1-df65c01a8b4b_d8c164be-03b1-4056-9ddc-a7033f19b82c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl hexanoate,106-70-7,"All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air.While no reliable acute dermal toxicity studies are available., the picture of all available data is consistent supporting also a low level of dermal toxicity for the category of fatty acid methyl esters. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89ff9fce-88c0-45c5-8412-91fc01933bfb/documents/IUC5-2d656336-1243-4e25-acdf-a708e46ba23f_2448e27c-261c-480e-ae80-56091ddb5dc9.html,,,,,, Methyl cinnamate,103-26-4,"NOAEL (subacute, oral, rat): 300 mg/kg bw/day resulted from the 28-day OECD 422 test with methyl cinnamate;NOAEL (subchronic, oral, rat): 4100 ppm (i.e. 275 mg/kg bw/d (male) and 300 mg/kg bw/day (female)) based on the read-across to cinnamaldehyde administered as supporting substance, supported by same study on mice with NOAEL of 4100 ppm (i.e. 650 mg/kg bw/d (male) and 625 mg/kg bw/d (female)).NOAEL (chronic, oral, rat): 200 mg/kg bw/d (male and female) based on the read-across to cinnamaldehyde administered as supporting substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13cd1efa-f057-40e4-8497-b94d0a79a499/documents/IUC5-22128b48-19f5-4cfd-a113-27d577ad01a0_8f4d449d-401e-409e-9b8a-8e61c6b4c2aa.html,,,,,, Methyl cinnamate,103-26-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13cd1efa-f057-40e4-8497-b94d0a79a499/documents/IUC5-22128b48-19f5-4cfd-a113-27d577ad01a0_8f4d449d-401e-409e-9b8a-8e61c6b4c2aa.html,Chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Methyl cinnamate,103-26-4,"LD50(oral, rat): 2610 mg/kg bw;LD50 (dermal, rabbit): > 5000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13cd1efa-f057-40e4-8497-b94d0a79a499/documents/IUC5-98807627-7793-4673-8c1e-383bb6ffd454_8f4d449d-401e-409e-9b8a-8e61c6b4c2aa.html,,,,,, Methyl cinnamate,103-26-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13cd1efa-f057-40e4-8497-b94d0a79a499/documents/IUC5-98807627-7793-4673-8c1e-383bb6ffd454_8f4d449d-401e-409e-9b8a-8e61c6b4c2aa.html,,oral,LD50,"2,610 mg/kg bw",no adverse effect observed, Methyl cinnamate,103-26-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13cd1efa-f057-40e4-8497-b94d0a79a499/documents/IUC5-98807627-7793-4673-8c1e-383bb6ffd454_8f4d449d-401e-409e-9b8a-8e61c6b4c2aa.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Methyl cyclohexylacetate,14352-61-5,"The acute toxicity to rats has been determined by the acute toxic class method. The LD50 is 2,500 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3911f492-a57f-4300-b0d6-3de9505a5882/documents/a83bc284-1bff-4d66-9b65-8f2f61516ef2_aa4f958e-f579-4ed3-9d70-662074b0fcd1.html,,,,,, Methyl cyclohexylacetate,14352-61-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3911f492-a57f-4300-b0d6-3de9505a5882/documents/a83bc284-1bff-4d66-9b65-8f2f61516ef2_aa4f958e-f579-4ed3-9d70-662074b0fcd1.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, Methyl cyclopentylideneacetate,40203-73-4,"Oral: LD50= 3362 mg/kg bw, male/female rat, equiv. to OECD 401, Industrial Bio-Test Laboratories Inc. 1977 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbffc6b5-2cd9-4184-bc69-369d883a8f1b/documents/IUC5-35ea949b-4eda-4306-9d72-2589776839a4_0a40a812-4d7e-4a4c-8414-fd191ff00fdc.html,,,,,, Methyl cyclopentylideneacetate,40203-73-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbffc6b5-2cd9-4184-bc69-369d883a8f1b/documents/IUC5-35ea949b-4eda-4306-9d72-2589776839a4_0a40a812-4d7e-4a4c-8414-fd191ff00fdc.html,,oral,LD50,"3,362 mg/kg bw",no adverse effect observed, "2,2'-methyliminodiethanol",105-59-9,"In a sub-chronic dermal toxicity study in rats (similar to OECD TG 411), local and systemic NOAELs of 100 mg/kg bw/day (corresponding to 0.8 mg/cm2) and 750 mg/kg bw/day were established, respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f70a6dc-d841-4a28-ab2f-b5c2a519d338/documents/IUC5-8a0c21ea-b05e-4d9e-bd37-394965a9f1c5_5b86b385-b7a9-42e8-8faa-6d425ac7f930.html,,,,,, "2,2'-methyliminodiethanol",105-59-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f70a6dc-d841-4a28-ab2f-b5c2a519d338/documents/IUC5-8a0c21ea-b05e-4d9e-bd37-394965a9f1c5_5b86b385-b7a9-42e8-8faa-6d425ac7f930.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,750 mg/kg bw/day,,rat "2,2'-methyliminodiethanol",105-59-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f70a6dc-d841-4a28-ab2f-b5c2a519d338/documents/IUC5-8a0c21ea-b05e-4d9e-bd37-394965a9f1c5_5b86b385-b7a9-42e8-8faa-6d425ac7f930.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.8 mg/cm2,adverse effect observed,rat "2,2'-methyliminodiethanol",105-59-9,"MDEA has a low acute oral, inhalation and dermal toxicity. The oral LD50 is 4680 mg/kg bw in rats. In inhalation risk tests with rats no mortality was observed after 6 and 8 hours exposure to a saturated MDEA vapour atmosphere. The LD50 for the dermal route is > 2000 mg/kg bw in rabbits. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f70a6dc-d841-4a28-ab2f-b5c2a519d338/documents/IUC5-26df7f59-905d-4ed2-b2ea-c8284235f4d4_5b86b385-b7a9-42e8-8faa-6d425ac7f930.html,,,,,, "2,2'-methyliminodiethanol",105-59-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f70a6dc-d841-4a28-ab2f-b5c2a519d338/documents/IUC5-26df7f59-905d-4ed2-b2ea-c8284235f4d4_5b86b385-b7a9-42e8-8faa-6d425ac7f930.html,,oral,LD50,"4,680 mg/kg bw",adverse effect observed, "2,2'-methyliminodiethanol",105-59-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f70a6dc-d841-4a28-ab2f-b5c2a519d338/documents/IUC5-26df7f59-905d-4ed2-b2ea-c8284235f4d4_5b86b385-b7a9-42e8-8faa-6d425ac7f930.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Methyl 2,4-dihydroxy-3,6-dimethylbenzoate",4707-47-5," The NOAEL for systemic toxicity in a dietary OECD TG 422 is > 717 and > 1175 mg/kg bw for males and females, respectively (equivalent to 7500 ppm nominal) and therefore it can be concluded that no adverse effects are seen. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a087923-8890-4095-a0ea-545d7ca0d237/documents/IUC5-b6021603-cec3-48f9-b893-a9193f28cb8e_7b6621f3-e0fc-4f93-88e1-9ca75a2e2953.html,,,,,, "Methyl 2,4-dihydroxy-3,6-dimethylbenzoate",4707-47-5," Acute oral toxicity: OECD TG 401: > 5000 mg/kg bw. Acute dermal toxicity: OECD TG 402: > 5000 mg/kg bw Acute inhalation: no adverse effects predicted based on low oral toxicity, low vapour pressure and the substance has a minor respirable fraction (ca. 5%). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a087923-8890-4095-a0ea-545d7ca0d237/documents/af1e5ee2-60c7-4ac5-b514-68ac2e339a59_7b6621f3-e0fc-4f93-88e1-9ca75a2e2953.html,,,,,, "2-isopropyl-N,2,3-trimethylbutyramide",51115-67-4," A key study (Lackenby (1987)), equivalent or similar to OECD TG 420 was performed to determine the acute oral median lethal dose (LD50) of WS-23 in the rat. Based on the results of the screening study, eight groups, each of 5 fasted rats (5 males or 5 females) were treated with a single oral dose at dose levels between 255 and 1000 mg/kg.   The acute oral median lethal dose and 95% fiducial limits were calculated by a probit method. The following values were obtained: Males (only) - 533 mg/kg (398 - 694) Females (only) - 490 mg/kg (95% fiducial limits could not be calculated for this sex) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd7e87b6-4bac-4afc-9d22-bf517f415fc0/documents/f1b1409e-4af1-40c2-9e62-03aa5374c52a_1b146238-a9ba-440f-963d-63583498b949.html,,,,,, "2-isopropyl-N,2,3-trimethylbutyramide",51115-67-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd7e87b6-4bac-4afc-9d22-bf517f415fc0/documents/f1b1409e-4af1-40c2-9e62-03aa5374c52a_1b146238-a9ba-440f-963d-63583498b949.html,,oral,LD50,490 mg/kg bw,adverse effect observed, 4-allylveratrole,93-15-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b34a51e5-ebda-4c6a-930d-b3131b699f66/documents/f03d8c04-090d-496d-aa96-32b1aa9109fb_bf81eebb-ed4c-42ef-a781-6836fa6a32c5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 4-allylveratrole,93-15-2, OECD 423 (Methyl Eugenol): LD50 (oral; rat) 2500 mg/kg bw OECD 402 (Methyl Eugenol). LD50 (dermal; rat) > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b34a51e5-ebda-4c6a-930d-b3131b699f66/documents/71a562a6-6b50-4116-a148-23daca8b0d01_bf81eebb-ed4c-42ef-a781-6836fa6a32c5.html,,,,,, 4-allylveratrole,93-15-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b34a51e5-ebda-4c6a-930d-b3131b699f66/documents/71a562a6-6b50-4116-a148-23daca8b0d01_bf81eebb-ed4c-42ef-a781-6836fa6a32c5.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, 4-allylveratrole,93-15-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b34a51e5-ebda-4c6a-930d-b3131b699f66/documents/71a562a6-6b50-4116-a148-23daca8b0d01_bf81eebb-ed4c-42ef-a781-6836fa6a32c5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl 2-hexyl-3-oxocyclopentanecarboxylate,37172-53-5," - Oral: NOAEL = 100 mg/kg bw/day (both sexes), based on data from a GLP compliant OECD 408 study with Hedione (MDJ) a structural analogue, which is considered the key study. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35f29238-3556-4b01-beb6-1984675836c8/documents/489b3b59-7227-49ca-9246-7bc7733170a5_d34146ee-ea8c-47b4-8eb1-3c6e37a1aacd.html,,,,,, Methyl 2-hexyl-3-oxocyclopentanecarboxylate,37172-53-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35f29238-3556-4b01-beb6-1984675836c8/documents/489b3b59-7227-49ca-9246-7bc7733170a5_d34146ee-ea8c-47b4-8eb1-3c6e37a1aacd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Methyl 2-hexyl-3-oxocyclopentanecarboxylate,37172-53-5, Oral LD50 is >5000 mg/kg bw Dermal LD50 is >5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35f29238-3556-4b01-beb6-1984675836c8/documents/8efea581-11e5-4538-84e9-42c6570b372f_d34146ee-ea8c-47b4-8eb1-3c6e37a1aacd.html,,,,,, Methyl 2-hexyl-3-oxocyclopentanecarboxylate,37172-53-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35f29238-3556-4b01-beb6-1984675836c8/documents/8efea581-11e5-4538-84e9-42c6570b372f_d34146ee-ea8c-47b4-8eb1-3c6e37a1aacd.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Methyl 2-hexyl-3-oxocyclopentanecarboxylate,37172-53-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35f29238-3556-4b01-beb6-1984675836c8/documents/8efea581-11e5-4538-84e9-42c6570b372f_d34146ee-ea8c-47b4-8eb1-3c6e37a1aacd.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, 1-methoxyhexane,4747-07-3,"Acute oral toxicity: 720 mg/kg bw (720 and 1800 mg/kg bw for females and males, respectively), based on read-across from 1 -Hexanol, which was tested in OECD TG 401. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/949d16b7-4e86-42d5-89d5-d03e284e7046/documents/a4bc4a65-810f-4b45-9a7c-7deafa67aa0e_ee47df19-5999-4ec7-b773-f8f7d7ff20b2.html,,,,,, 1-methoxyhexane,4747-07-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/949d16b7-4e86-42d5-89d5-d03e284e7046/documents/a4bc4a65-810f-4b45-9a7c-7deafa67aa0e_ee47df19-5999-4ec7-b773-f8f7d7ff20b2.html,,oral,LD50,720 mg/kg bw,adverse effect observed, "Resin acids and Rosin acids, hydrogenated, Me esters",8050-15-5," Information is available on the oral repeated dose toxicity of Rosin esters (simple, linear, and bulky). No treatment-related or biologically relevant findings were apparent in rats following oral sub-chronic dietary exposure to Resin acids and rosin acids, esters with glycerol, Resin acids and rosin acids, esters with ethylene glycol, Resin acids and rosin acids, esters with triethylene glycol, Resin acids and rosin acids, hydrogenated, esters with glycerol and Resin acids and rosin acids, hydrogenated, esters with pentaerythritol. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/871fd79a-6ace-4810-baac-e5c31ed64fe4/documents/ec571f35-1b86-4851-8c52-0add68b4d02a_b425e196-1653-4de2-85a4-37ccc4050839.html,,,,,, "Resin acids and Rosin acids, hydrogenated, Me esters",8050-15-5,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/871fd79a-6ace-4810-baac-e5c31ed64fe4/documents/09e2a78a-fc09-414f-9661-f2ddebdbdb53_b425e196-1653-4de2-85a4-37ccc4050839.html,,,,,, "Resin acids and Rosin acids, hydrogenated, Me esters",8050-15-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/871fd79a-6ace-4810-baac-e5c31ed64fe4/documents/09e2a78a-fc09-414f-9661-f2ddebdbdb53_b425e196-1653-4de2-85a4-37ccc4050839.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, hydrogenated, Me esters",8050-15-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/871fd79a-6ace-4810-baac-e5c31ed64fe4/documents/09e2a78a-fc09-414f-9661-f2ddebdbdb53_b425e196-1653-4de2-85a4-37ccc4050839.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl 12-hydroxyoctadecanoate,141-23-1, No adverse effects observed ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ac97b29-b090-413f-b101-93da4c27ecb6/documents/ba3b2b6a-5ef4-4fa8-ba79-c9ae99901c86_a6706c58-2947-45e3-b454-5ff3b05824a5.html,,,,,, Methyl 12-hydroxyoctadecanoate,141-23-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ac97b29-b090-413f-b101-93da4c27ecb6/documents/ba3b2b6a-5ef4-4fa8-ba79-c9ae99901c86_a6706c58-2947-45e3-b454-5ff3b05824a5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"6,000 mg/kg bw/day",,rat Methyl 12-hydroxyoctadecanoate,141-23-1, Not acutely toxic ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ac97b29-b090-413f-b101-93da4c27ecb6/documents/30405d3b-b32f-4136-ba60-70847e906336_a6706c58-2947-45e3-b454-5ff3b05824a5.html,,,,,, Methyl 12-hydroxyoctadecanoate,141-23-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ac97b29-b090-413f-b101-93da4c27ecb6/documents/30405d3b-b32f-4136-ba60-70847e906336_a6706c58-2947-45e3-b454-5ff3b05824a5.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-isobutyl-2-methyl-1,3-dioxolane-4-methanol",5660-53-7,"NOAEL for systemic toxicity = 1000 mg/kg bw/day for males since the observed effects in males are not relevant for human risk assessment. NOEL for systemic toxicity = 1000 mg/kg bw/day for females based on the absence of significant effects related to test item on females (data obtained on the analogue substance 2,2-dimethyl-1,3-dioxolane-4-methanol) ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9def1f7-170e-4e06-81be-af24ef028aae/documents/IUC5-ff6e6c48-043b-4f9f-8ff8-208106b54029_ab1776d2-4960-4c7d-a2cd-366feed5d76c.html,,,,,, "2-isobutyl-2-methyl-1,3-dioxolane-4-methanol",5660-53-7,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9def1f7-170e-4e06-81be-af24ef028aae/documents/IUC5-ff6e6c48-043b-4f9f-8ff8-208106b54029_ab1776d2-4960-4c7d-a2cd-366feed5d76c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-isobutyl-2-methyl-1,3-dioxolane-4-methanol",5660-53-7,"- One Acute oral toxicity study (Gemio dos Reis, 2011; OECD 423, Rel. 1) is available and showed a LD50 > 2000 mg/kg bw in female WIstar rats. This study indicates that the acute toxicity of 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol is low for the oral route.- One acute dermal toxicity study (R. Leclère, 2013; OECD 402, Rel. 2) is available on the analogue substance 2,2-dimethyl-1,3-dioxolane-4-methanol and showed a LD50 > 2000 mg/kg bw in rats . By analogy, 2-isobutyl-2-methyl-1,3-dioxolane-4-methanol is expected to be of no to low acute dermal toxicity. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9def1f7-170e-4e06-81be-af24ef028aae/documents/IUC5-981ad42c-7da6-4b36-96bf-9185f8d87908_ab1776d2-4960-4c7d-a2cd-366feed5d76c.html,,,,,, "2-isobutyl-2-methyl-1,3-dioxolane-4-methanol",5660-53-7,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9def1f7-170e-4e06-81be-af24ef028aae/documents/IUC5-981ad42c-7da6-4b36-96bf-9185f8d87908_ab1776d2-4960-4c7d-a2cd-366feed5d76c.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-isobutyl-2-methyl-1,3-dioxolane-4-methanol",5660-53-7,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9def1f7-170e-4e06-81be-af24ef028aae/documents/IUC5-981ad42c-7da6-4b36-96bf-9185f8d87908_ab1776d2-4960-4c7d-a2cd-366feed5d76c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 3-methylbutanone,563-80-4," A 90 -day inhalation inhalation study with special staining for a2u was conducted in rats. There were no adverse effects found, and the NOAEC was the highest exposure concentration. Staining of the kidney for a2u gave positive staining. Since the a2u protein is only found in the male rat kidney, such staining suggests that previous indications of nephropathy in other studies (and what most likely drove this testing requirement) occured by a route that is not relevant to humans. A 30 -day interim sacrifice was added to the protocol using additional rats in the control and high dose groups. The reason for this modification is that studies with other ketones (methyl isobutyl ketone) showed that the a2u signal can diminish with age and that 30 days was a more relevant time for this metric than 90 days. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e63a56c0-6fe4-4e48-b4f5-6e6071389b4d/documents/IUC5-e055c07b-0ebe-461d-97a5-0384f08f9ecf_8387b3e2-2d54-49c2-88cc-e100da352f26.html,,,,,, 3-methylbutanone,563-80-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e63a56c0-6fe4-4e48-b4f5-6e6071389b4d/documents/IUC5-e055c07b-0ebe-461d-97a5-0384f08f9ecf_8387b3e2-2d54-49c2-88cc-e100da352f26.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"5,284 mg/m3",,rat 3-methylbutanone,563-80-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e63a56c0-6fe4-4e48-b4f5-6e6071389b4d/documents/IUC5-e055c07b-0ebe-461d-97a5-0384f08f9ecf_8387b3e2-2d54-49c2-88cc-e100da352f26.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"5,284 mg/m3",no adverse effect observed,rat 3-methylbutanone,563-80-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e63a56c0-6fe4-4e48-b4f5-6e6071389b4d/documents/IUC5-0af19095-6fa2-4aa5-aba4-b4bb9dd10bd6_8387b3e2-2d54-49c2-88cc-e100da352f26.html,,oral,LD50,"3,078 mg/kg bw",, 3-methylbutanone,563-80-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e63a56c0-6fe4-4e48-b4f5-6e6071389b4d/documents/IUC5-0af19095-6fa2-4aa5-aba4-b4bb9dd10bd6_8387b3e2-2d54-49c2-88cc-e100da352f26.html,,dermal,LD50,"16,000 mg/kg bw",, 3-methylbutanone,563-80-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e63a56c0-6fe4-4e48-b4f5-6e6071389b4d/documents/IUC5-0af19095-6fa2-4aa5-aba4-b4bb9dd10bd6_8387b3e2-2d54-49c2-88cc-e100da352f26.html,,inhalation,LC50,"22,464 mg/m3",, Methyl 4(or 1)-isopropyl-1(or 4)-methylbicyclo[2.2.2]oct-5-ene-2-carboxylate,68966-86-9,"In an acute oral study, Sprague-Dawley rats were exposed to a single dose of the test item (1429, 2000, 2800 and 3920 mg/kg bw) via oral gavage. Acute toxicological symptoms attributed to the test item were observed, however, no macroscopic organ changes were detected in pathological examinations post-mortem. Fifty percent mortality was not observed at any tested dose level, however, due to the unexpectedly low mortality at the high dose, the LD50 value was not statistically quantifiable. The authors suggest a projected LD50 value of >2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa433145-f90a-4549-ad9f-8497e38987cb/documents/1326d4f2-48ed-47b6-b6b2-c1cddb478835_5ba6852a-378d-4ad2-983a-e1ed19fc57a9.html,,,,,, Methyl 4(or 1)-isopropyl-1(or 4)-methylbicyclo[2.2.2]oct-5-ene-2-carboxylate,68966-86-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa433145-f90a-4549-ad9f-8497e38987cb/documents/1326d4f2-48ed-47b6-b6b2-c1cddb478835_5ba6852a-378d-4ad2-983a-e1ed19fc57a9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl (S)-(-)-lactate,27871-49-4," No studies with the target substance methyl (S)-lactate itself are available for the assessment of repeated dose toxicity. However, an oral and an inhalation repeated dose toxicity study were conducted with suitable read-across partners which are thus used to assess the specific target organ toxicity of the target substance. Three sub-acute inhalation toxicity studies with ethyl (S)-lactate and butyl (S)-lactate revealed clear respiratory local effects, described as histopathological changes in the olfactory and respiratory epithelia. No clear systemic toxic effects were detected. Oral sub-chronic toxicity is addressed by a study conducted with a suitable read-across partner, calcium lactate pentahydrate. No adverse effects were reported after oral administration of calcium lactate pentahydrate via drinking water. The NOAEL in this study is 4500 mg/kg bw/day for both sexes (calculated from 50,000 mg/L by applying a conversion factor of 0.09 for rats as recommended in the EFSA guidance document [EFSA Journal 2012 (10(3): 2579]). Therefore, lactic acid/free lactate is of no systemic toxicological concern. In addition, in a sub-chronic repeated dose toxicity study, methanol was administered daily to 30 Sprague-Dawley rats/sex/dose via oral gavage at dose levels of 0, 100, 500 and 2500 mg/kg bw/day for total of 90 days. Elevated levels (p≤ 0.05 in males) of serum alanine transaminase (ALT) and serum alkaline phosphatase (SAP), and increased (but not statistically significant) liver weights in both male and female rats suggest possible treatment-related effects in rats bolus dosed with 2500 mg methanol/kg bw/day despite the absence of supportive histopathologic lesions in the liver. Brain weights of high-dose group (2500 mg/kg bw/day) males and females were significantly less than those of the control group at terminal sacrifice. Based on these findings, 500 mg/kg bw/day methanol is considered as the NOAEL from this rat study (corresponding to 1625 mg/kg bw/day Methyl (S)-lactate). This dose is much higher as the limit dose of 1000 mg/kg bw/day mentioned in the OECD TG 408. In a sub-acute repeated dose toxicity study, methanol was administered to 5 male/female Wistar rats/dose by inhalation in whole body exposure chambers at concentrations of 0, 500, 2000 and 5000 ppm as vapour, for 6 hours per day, 5 days/week for a total of 20 days. No treatment-related effects on mortality, clinical signs, body / organ weights, gross/histopathologic or ophthalmoscopic examinations were noted. The only treatment and dose-related effect noted was that of mucoid nasal discharge in rats, which was considered reflective of upper respiratory tract irritation. Based on the results, the NOAEC can be considered to be 5000 ppm, which equals 6.552 mg/L. In summary, no classification for repeated specific target organ toxicity is warranted for the target substance as no adverse systemic effects were observed up to the limit doses of the respective OECD test guidelines. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c520bf47-5b48-4e5d-9a9b-d2590645251c/documents/IUC5-f7eed66c-c795-4b1d-93d0-ce54bc2c88f1_215b8f30-8fb0-4c52-a968-4dd9e7ec1687.html,,,,,, Methyl (S)-(-)-lactate,27871-49-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c520bf47-5b48-4e5d-9a9b-d2590645251c/documents/IUC5-f7eed66c-c795-4b1d-93d0-ce54bc2c88f1_215b8f30-8fb0-4c52-a968-4dd9e7ec1687.html,Repeated dose toxicity – local effects,inhalation,NOAEC,150 mg/m3,adverse effect observed,rat Methyl (S)-(-)-lactate,27871-49-4," No acute toxicity data is available for the target substance Methyl (S)-lactate itself. Therefore, available data from suitable read-across substances was used for the assessment of the potential of Methyl (S)-lactate to induce acute toxicity. In acute oral toxicity studies conducted according to OECD guideline 401, groups of Wistar rats (5/sex) were exposed to the source substances Propyl (S)-lactate, Ethyl (S)-lactate and Butyl (S)-lactate as a single dose of 2000 mg/kg bw. In all studies, the oral LD50 value was established to exceed 2000 mg/kg bw. In acute inhalation toxicity studies conducted according to OECD guideline 403, groups of Wistar rats (5/sex) were exposed to the source substances Ethyl lactate, Ethylhexyl (S)-lactate and Butyl (S)-lactate for 4 hours. No mortality occurred in any study. In acute dermal toxicity studies conducted according to OECD guideline 402, groups of Wistar rats (5/sex) were exposed to the source substances Propyl (S)-lactate and L(+) lactic acid as a single dose of 2000 mg/kg bw. In both studies, the dermal LD50 value was established to exceed 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c520bf47-5b48-4e5d-9a9b-d2590645251c/documents/IUC5-c30ffdaf-01f6-4217-921a-ad30bed94087_215b8f30-8fb0-4c52-a968-4dd9e7ec1687.html,,,,,, Methyl (S)-(-)-lactate,27871-49-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c520bf47-5b48-4e5d-9a9b-d2590645251c/documents/IUC5-c30ffdaf-01f6-4217-921a-ad30bed94087_215b8f30-8fb0-4c52-a968-4dd9e7ec1687.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Methyl (S)-(-)-lactate,27871-49-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c520bf47-5b48-4e5d-9a9b-d2590645251c/documents/IUC5-c30ffdaf-01f6-4217-921a-ad30bed94087_215b8f30-8fb0-4c52-a968-4dd9e7ec1687.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Methyl (S)-(-)-lactate,27871-49-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c520bf47-5b48-4e5d-9a9b-d2590645251c/documents/IUC5-c30ffdaf-01f6-4217-921a-ad30bed94087_215b8f30-8fb0-4c52-a968-4dd9e7ec1687.html,,inhalation,LC50,"> 5,140 mg/m3",no adverse effect observed, Methyl methacrylate,80-62-6," Oral 2 years, rat, drinking water: NOAEL >= 2000 ppm/day (corresponding to 124.1 mg/kg bw/day and 164 mg/kg bw/day, for males and females, respectively, on the basis of treatment specific fluid consumption rates and body weights; Borzelleca et al. 1964) Inhalation For systemic effects: NOAEC rat, 2yr: 500 ppm (2028 mg/m³; NTP 1986) in absence of adverse effects For local effects: NOAEC rat, 2yr: 25 ppm (104 mg/m3; Lomax et al. 1997) due to nasal lesions in higher doses The EU ESR (2002) and SCOEL review (2005) recognised differences between rodents and humans regarding the physiology of the nasal passages, metabolic activity result in the greater susceptibility of rodents compared with humans to inhaled esters. Consequently, a value of 50 ppm (SCOEL, 2005) is regarded as being the NOAEC(=DNEL) in humans. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af9b9489-f745-4cba-a1b7-acc6e286504e/documents/IUC5-6b2795fc-6475-4116-adfd-8cdf79f3c300_9845a94a-2fc1-4b68-8de4-de635692a613.html,,,,,, Methyl methacrylate,80-62-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af9b9489-f745-4cba-a1b7-acc6e286504e/documents/IUC5-6b2795fc-6475-4116-adfd-8cdf79f3c300_9845a94a-2fc1-4b68-8de4-de635692a613.html,Chronic toxicity – systemic effects,oral,NOAEL,124 mg/kg bw/day,,rat Methyl methacrylate,80-62-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af9b9489-f745-4cba-a1b7-acc6e286504e/documents/IUC5-6b2795fc-6475-4116-adfd-8cdf79f3c300_9845a94a-2fc1-4b68-8de4-de635692a613.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"2,080 mg/m3",,rat Methyl methacrylate,80-62-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af9b9489-f745-4cba-a1b7-acc6e286504e/documents/IUC5-6b2795fc-6475-4116-adfd-8cdf79f3c300_9845a94a-2fc1-4b68-8de4-de635692a613.html,Repeated dose toxicity – local effects,inhalation,NOAEC,104 mg/m3,adverse effect observed,rat Methyl methacrylate,80-62-6,"Oral LD50 rat: ca. 7900 mg/kg bw (Deichmann 1941)InhalationLC50 rat, 4 h exposition: 29.8 mg/L (Tansy et al. 1980)DermalLD50 rat, 24 h, occlusive conditions: >5000 mg/kg bw (Rohm & Haas 1982) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af9b9489-f745-4cba-a1b7-acc6e286504e/documents/IUC5-4e394f26-d639-4af3-b4be-18f5967c7c46_9845a94a-2fc1-4b68-8de4-de635692a613.html,,,,,, Methyl methacrylate,80-62-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af9b9489-f745-4cba-a1b7-acc6e286504e/documents/IUC5-4e394f26-d639-4af3-b4be-18f5967c7c46_9845a94a-2fc1-4b68-8de4-de635692a613.html,,oral,LD50,"7,900 mg/kg bw",no adverse effect observed, Methyl methacrylate,80-62-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af9b9489-f745-4cba-a1b7-acc6e286504e/documents/IUC5-4e394f26-d639-4af3-b4be-18f5967c7c46_9845a94a-2fc1-4b68-8de4-de635692a613.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Methyl methacrylate,80-62-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af9b9489-f745-4cba-a1b7-acc6e286504e/documents/IUC5-4e394f26-d639-4af3-b4be-18f5967c7c46_9845a94a-2fc1-4b68-8de4-de635692a613.html,,inhalation,LC50,"29,800 mg/m3",no adverse effect observed, "4-methylmorpholine 4-oxide, monohydrate",7529-22-8," There are two GLP-compliant animal studies available regarding repeated oral exposure to NMMO. Martell (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test in rats according to OECD 422. A recovery (satellite) group of males and females was included. From this study, a NOAEL of 50 mg/kg bw/day and a LOAEL of 500 mg/kg bw/day were established for NMMO. In a subsequent 90-d oral repeated dose toxicity study according to OECD Test Guideline 408 (Murie, 2017), male rats dosed with 300 mg/kg bw/day had significantly lowered mean body weight (more than 15% reduction) compared to control male rats. As no recovery period was included in this study, this effect could be considered as adverse, and therefore, the NOAEL was established at 100 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/205a2327-cc5d-4a52-b76d-e90498e6226d/documents/IUC5-f3fffa37-4e16-494d-8f28-756721d6bb96_6b907300-4aa2-4769-878d-7c89343e526c.html,,,,,, "4-methylmorpholine 4-oxide, monohydrate",7529-22-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/205a2327-cc5d-4a52-b76d-e90498e6226d/documents/IUC5-f3fffa37-4e16-494d-8f28-756721d6bb96_6b907300-4aa2-4769-878d-7c89343e526c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "4-methylmorpholine 4-oxide, monohydrate",7529-22-8," It should be noted that all tests performed in the past, have used the 50% aqueous solution which is the marketed product. Acute toxicity: oral: A KL 1 acute oral toxicity test was performed in male and female Sprague Dawley rats according to a guideline similar to OECD Guideline 401 (Mallory VT, 1981). This study was selected as key study. In addition, a supporting KL 2 study was available (Vinegar MB, 1977). Derived LD50 (oral): 4600 mg/kg bw Acute toxicity: inhalation No reliable data were available. However, this endpoint is waived as specific data are available for the oral and dermal exposure route. Acute toxicity: dermal A KL 1 acute dermal toxicity test was performed in male and female New Zealand White rabbits according to a guideline similar to OECD Guideline 402 (Auletta CS, 1981). This study was selected as key study. Derived LD50 (dermal): >4000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/205a2327-cc5d-4a52-b76d-e90498e6226d/documents/IUC5-84659037-f860-4ee1-b07a-97d1b9884bd9_6b907300-4aa2-4769-878d-7c89343e526c.html,,,,,, "4-methylmorpholine 4-oxide, monohydrate",7529-22-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/205a2327-cc5d-4a52-b76d-e90498e6226d/documents/IUC5-84659037-f860-4ee1-b07a-97d1b9884bd9_6b907300-4aa2-4769-878d-7c89343e526c.html,,oral,LD50,"4,600 mg/kg bw",adverse effect observed, "4-methylmorpholine 4-oxide, monohydrate",7529-22-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/205a2327-cc5d-4a52-b76d-e90498e6226d/documents/IUC5-84659037-f860-4ee1-b07a-97d1b9884bd9_6b907300-4aa2-4769-878d-7c89343e526c.html,,dermal,LD50,"> 4,000 mg/kg bw",no adverse effect observed, Methyl myristate,124-10-7,"OECD 422, rat: NOAEL = 1000 mg/kg bw/d of the read across substance methyl laurate. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d60dc98-6149-47dc-b1e7-5db736539ae0/documents/IUC5-6ed685dc-de34-4d7b-bdd4-e5d3e0d8e2e0_bc993804-bbbe-49bd-a7c6-8257de8b2f11.html,,,,,, Methyl myristate,124-10-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d60dc98-6149-47dc-b1e7-5db736539ae0/documents/IUC5-6ed685dc-de34-4d7b-bdd4-e5d3e0d8e2e0_bc993804-bbbe-49bd-a7c6-8257de8b2f11.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,130 mg/kg bw/day",, Methyl myristate,124-10-7,"All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air.While no reliable acute dermal toxicity studies are available, the picture of all available data is consistent supporting also a low level of dermal toxicity for the category of fatty acid methyl esters. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d60dc98-6149-47dc-b1e7-5db736539ae0/documents/IUC5-e45e906a-d89f-4e4d-a34d-44793052573a_bc993804-bbbe-49bd-a7c6-8257de8b2f11.html,,,,,, Methyl N-methylanthranilate,85-91-6," Repeated dose toxicity: via oral route; The No Observed Adverse Effect Level (NOAEL) was considered to be 300 ppm (20 mg/kg body weight/day) when CFE male and female rat treated with test substance for 90 days by oral feed. Repeated inhalation study: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance Methyl 2-(methylamino)benzoate (85-91-6) which is reported as 0.02055169 mmHg at 25 C. .Thus, exposure to inhalable dust, mist and vapour of the chemical Methyl 2-(methylamino)benzoate is highly unlikely. Therefore this study is considered for waiver. Repeated dermal study; The acute toxicity value for Methyl 2-(methylamino)benzoate (85-91-6) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that Methyl 2-(methylamino)benzoate shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Methyl 2-(methylamino)benzoate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e74f089-2db0-4daa-920b-aacac7c8497a/documents/b560cd41-c28e-4e2a-8d9a-1608544c41e8_7fe5f5d7-eea1-403b-ba60-de0c82eefb05.html,,,,,, Methyl N-methylanthranilate,85-91-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e74f089-2db0-4daa-920b-aacac7c8497a/documents/b560cd41-c28e-4e2a-8d9a-1608544c41e8_7fe5f5d7-eea1-403b-ba60-de0c82eefb05.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,24 mg/kg bw/day,,rat Methyl N-methylanthranilate,85-91-6," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.02055169 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e74f089-2db0-4daa-920b-aacac7c8497a/documents/293da132-9adb-4a83-be39-58fd49d45fa9_7fe5f5d7-eea1-403b-ba60-de0c82eefb05.html,,,,,, Methyl N-methylanthranilate,85-91-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e74f089-2db0-4daa-920b-aacac7c8497a/documents/293da132-9adb-4a83-be39-58fd49d45fa9_7fe5f5d7-eea1-403b-ba60-de0c82eefb05.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl N-methylanthranilate,85-91-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e74f089-2db0-4daa-920b-aacac7c8497a/documents/293da132-9adb-4a83-be39-58fd49d45fa9_7fe5f5d7-eea1-403b-ba60-de0c82eefb05.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, undecan-2-one; methyl nonyl ketone,112-12-9," Repeated dose toxicity: Oral Based on the data available from different studies, the No Observed Adverse Effect Level (NOAEL) for test material was considered to be 1000 mg/kg/day for repeated dose oral toxicity study, when rodents were treated with test material orally by gavage. Repeated dose toxicity: Dermal A short-term toxicity study does not need to be conducted because exposure of humans via dermal in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the acute dermal toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. Repeated dose toxicity: Inhalation A short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, according to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the test chemical which is reported as 0.0414 mmHg at 20 C. Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely. Therefore this study is considered for waiver ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a2e8455-e991-4110-adff-527de29448d4/documents/1dde3c58-de6a-4e92-bc15-1b5242dd2afc_957ab16f-3834-456f-bf07-be33579ed5ac.html,,,,,, undecan-2-one; methyl nonyl ketone,112-12-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a2e8455-e991-4110-adff-527de29448d4/documents/1dde3c58-de6a-4e92-bc15-1b5242dd2afc_957ab16f-3834-456f-bf07-be33579ed5ac.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat undecan-2-one; methyl nonyl ketone,112-12-9," Acute oral toxicity: The oral median lethal dose (LD50) of Methyl Nonyl Ketone was determined in rats. The LD50 was >2500 mg/kg bw for female rats. Based on these results and according to the EU classification criteria outlined in Annex I of the CLP Regulation (1272/2008/EC) the compound does not need to be classified. Acute inhalation toxicity: The acute inhalation toxicity dose (LC50) was considered to be >5430 mg/m³, when rats were exposed to Methyl nonyl ketone via inhalation route. Acute dermal toxicity: The lethal concentration (LD50) value for acute dermal toxicity test was considered to be >5000 mg/kg bw,when rabbits were treated with test chemical Methyl nonyl ketone via dermal route. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a2e8455-e991-4110-adff-527de29448d4/documents/7ef82452-0db2-412b-8541-5e361f1773aa_957ab16f-3834-456f-bf07-be33579ed5ac.html,,,,,, undecan-2-one; methyl nonyl ketone,112-12-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a2e8455-e991-4110-adff-527de29448d4/documents/7ef82452-0db2-412b-8541-5e361f1773aa_957ab16f-3834-456f-bf07-be33579ed5ac.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, undecan-2-one; methyl nonyl ketone,112-12-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a2e8455-e991-4110-adff-527de29448d4/documents/7ef82452-0db2-412b-8541-5e361f1773aa_957ab16f-3834-456f-bf07-be33579ed5ac.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, undecan-2-one; methyl nonyl ketone,112-12-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a2e8455-e991-4110-adff-527de29448d4/documents/7ef82452-0db2-412b-8541-5e361f1773aa_957ab16f-3834-456f-bf07-be33579ed5ac.html,,inhalation,LC50,"5,430 mg/m3",no adverse effect observed, Methyl non-2-enoate,111-79-5, Acute oral toxicity: LD50 was considered to be > 5000 mg/kg bw when rat were treated with Methyl non-2-enoate orally. Acute dermal toxicity: LD50 was considered to be > 5000 mg/kg bw when rabbits were treated with Methyl non-2-enoate dermally.  ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df0d6cad-a8f6-4b09-ba00-91a2d43e0fac/documents/e9ec5ed7-187e-4b20-a1eb-cb72532785e8_ff8c6240-26fc-4453-8c60-31ac7f27dae6.html,,,,,, Methyl non-2-enoate,111-79-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df0d6cad-a8f6-4b09-ba00-91a2d43e0fac/documents/e9ec5ed7-187e-4b20-a1eb-cb72532785e8_ff8c6240-26fc-4453-8c60-31ac7f27dae6.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Methyl non-2-enoate,111-79-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df0d6cad-a8f6-4b09-ba00-91a2d43e0fac/documents/e9ec5ed7-187e-4b20-a1eb-cb72532785e8_ff8c6240-26fc-4453-8c60-31ac7f27dae6.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18 and C18-unsatd., Me esters",67762-38-3, NOAEL subcronic toxicity rat = 1000 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe0e1cb8-5e35-43fb-8f7b-cca8b0c40334/documents/IUC5-531fcf91-14f3-4e1c-8fa8-dbaa501f3e5c_67396501-a861-47d6-a42f-2c74e5ce4757.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., Me esters",67762-38-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe0e1cb8-5e35-43fb-8f7b-cca8b0c40334/documents/IUC5-531fcf91-14f3-4e1c-8fa8-dbaa501f3e5c_67396501-a861-47d6-a42f-2c74e5ce4757.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C16-18 and C18-unsatd., Me esters",67762-38-3, Non toxic LD50 oral rat > 5000 LD50 dermal rabbit > 2000 ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe0e1cb8-5e35-43fb-8f7b-cca8b0c40334/documents/IUC5-36a43603-f623-4c72-8a0a-f7f8a3559e2d_67396501-a861-47d6-a42f-2c74e5ce4757.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., Me esters",67762-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe0e1cb8-5e35-43fb-8f7b-cca8b0c40334/documents/IUC5-36a43603-f623-4c72-8a0a-f7f8a3559e2d_67396501-a861-47d6-a42f-2c74e5ce4757.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18 and C18-unsatd., Me esters",67762-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe0e1cb8-5e35-43fb-8f7b-cca8b0c40334/documents/IUC5-36a43603-f623-4c72-8a0a-f7f8a3559e2d_67396501-a861-47d6-a42f-2c74e5ce4757.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl p-toluate,99-75-2,"Maternal effects of equivocal relevance have been reported after inhalation exposure of rats, but exposure conditions and effects are insufficiently reported. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3753806f-fc29-48b9-96d8-05995746f113/documents/IUC5-91536f86-227a-4acf-9527-1abd6b06e9b2_2a48d21e-7314-4b5c-be8a-f02b6a212d8e.html,,,,,, "2-(Difluoromethoxymethyl)-1,1,1,2,3,3,3-heptafluoro-propane",163702-08-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0615849-bbb8-426c-8e45-b300f277265a/documents/8860d631-3b98-40d0-a226-901ffad3713d_c0719977-ac8e-4f67-ae7e-5c21d6771bcc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2-(Difluoromethoxymethyl)-1,1,1,2,3,3,3-heptafluoro-propane",163702-08-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0615849-bbb8-426c-8e45-b300f277265a/documents/82429de8-a33d-4315-b6f7-76f704ff0cfc_c0719977-ac8e-4f67-ae7e-5c21d6771bcc.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2-(Difluoromethoxymethyl)-1,1,1,2,3,3,3-heptafluoro-propane",163702-08-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0615849-bbb8-426c-8e45-b300f277265a/documents/82429de8-a33d-4315-b6f7-76f704ff0cfc_c0719977-ac8e-4f67-ae7e-5c21d6771bcc.html,,inhalation,LC50,> 5.388 mg/L,no adverse effect observed, (2-methoxyethyl)benzene,3558-60-9," Repeated dose (oral) toxicity: A short term repeated dose toxicity study, according to OECD Guideline 407 (Repeated Dose Toxicity Study for 28 days) was conducted using male and female Wistar rats. The test chemical was administered to male and female Wistar rats once a day for a minimum period of 28 days with 14 days treatment-free period. No treatment related effects on mortality/morbidity, clinical signs, detailed clinical observation, body weight, body weight gain, feed consumption, ophthalmoscopic examination, functional observational battery/neurobehavioral observation, hematology, clinical biochemistry, urinalysis, gross pathology and histopathology (vehicle control group and high dose group). Thus, based on all the observations and results, it was concluded that the test chemical did not induce significant local and systemic toxicity at all the tested doses and thus the NOAEL for the test chemical was observed to be 450 mg/kg bw. Repeated dose (inhalation) study: A short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment.According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the test chemical which is reported as 0.549 mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely. Therefore this study is considered for waiver. Repeated dose (dermal) study: A short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment.The acute toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/338f9564-db1b-4eaf-af69-49e9b0a7206b/documents/e202192c-0eee-4657-b704-4be8e412b0ac_84b9795c-cc5d-4705-9ddd-e65a8e0607f6.html,,,,,, (2-methoxyethyl)benzene,3558-60-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/338f9564-db1b-4eaf-af69-49e9b0a7206b/documents/e202192c-0eee-4657-b704-4be8e412b0ac_84b9795c-cc5d-4705-9ddd-e65a8e0607f6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat (2-methoxyethyl)benzene,3558-60-9," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on the study conducted on rats for the given test chemical. The study concluded that the LD50 value is 1049 mg/kg bw for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified as “Category IV” for acute oral toxicity.   Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to low vapour pressure of the test chemical. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on the study conducted on rats for the given test chemical. The study concluded that LD50 value is >2000 mg/kg bw for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/338f9564-db1b-4eaf-af69-49e9b0a7206b/documents/7bc241e4-9d4c-4914-8ebc-889de1c1bbab_84b9795c-cc5d-4705-9ddd-e65a8e0607f6.html,,,,,, (2-methoxyethyl)benzene,3558-60-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/338f9564-db1b-4eaf-af69-49e9b0a7206b/documents/7bc241e4-9d4c-4914-8ebc-889de1c1bbab_84b9795c-cc5d-4705-9ddd-e65a8e0607f6.html,,oral,LD50,"1,049 mg/kg bw",adverse effect observed, (2-methoxyethyl)benzene,3558-60-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/338f9564-db1b-4eaf-af69-49e9b0a7206b/documents/7bc241e4-9d4c-4914-8ebc-889de1c1bbab_84b9795c-cc5d-4705-9ddd-e65a8e0607f6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-methyl-4-phenylbutan-2-ol,103-05-9," Read-across to PEA (CAS No. 60-12-8) - Repeated dose toxicity (dermal, subchronic): NOEL = 500 mg/kg bw/day (Equivalent or similar to OECD 411) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/025fcdb7-55e2-4a83-8b74-2bb464b9bce3/documents/ed9ef65e-1822-4efe-b0f7-50b18a1cde05_904ee215-822b-43f1-ae03-9b21a39cfeb5.html,,,,,, 2-methyl-4-phenylbutan-2-ol,103-05-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/025fcdb7-55e2-4a83-8b74-2bb464b9bce3/documents/ed9ef65e-1822-4efe-b0f7-50b18a1cde05_904ee215-822b-43f1-ae03-9b21a39cfeb5.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rat 2-methyl-4-phenylbutan-2-ol,103-05-9, Acute oral toxicity: LD50 (female) = >2000 mg/kg bw (OECD 425/GLP) Read-across to PEA (CAS No. 60 -12 -8) - Acute inhalation toxicity: LC50 male/female = > 4.63 mg/L (nominal concentration) (Equivalent or similar to OECD 403/GLP) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/025fcdb7-55e2-4a83-8b74-2bb464b9bce3/documents/0e132317-14d3-4615-92f0-0ab4f68bafe8_904ee215-822b-43f1-ae03-9b21a39cfeb5.html,,,,,, 2-methyl-4-phenylbutan-2-ol,103-05-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/025fcdb7-55e2-4a83-8b74-2bb464b9bce3/documents/0e132317-14d3-4615-92f0-0ab4f68bafe8_904ee215-822b-43f1-ae03-9b21a39cfeb5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-methyl-4-phenylbutan-2-ol,103-05-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/025fcdb7-55e2-4a83-8b74-2bb464b9bce3/documents/0e132317-14d3-4615-92f0-0ab4f68bafe8_904ee215-822b-43f1-ae03-9b21a39cfeb5.html,,inhalation,LC50,4.63 mg/m3,no adverse effect observed, Methyl propionate,554-12-1," Acute Oral Sax's Handbook According to the handbook data the acute oral LD50 to rats is 5000 mg/kg, the acute oral LD50 to mice is 3460 mg/kg and the lethal dose low to the rabbit is 2550 mg/kg. Food and Chemical Toxicology The acute oral LD50 of the substance to rabbits was reported to be 2.5 - 3.2 g/kg with production of ataxia, gasping respirations and hypothermia at lethal dose levels (Browning, 1965, and Fasset, 1963) and 2.02 g/kg by Munch (1972). Acute Inhalation SafePharm Laboratories - EU Method B.4 (rat) Only one death occurred in a group of ten rats exposed to a mean achieved atmosphere concentration of 22.7 mg/L for four hours. It was therefore considered that the acute inhalation median lethal concentration (4 hr LC50) of the test material, in the Sprague-Dawley rat, was greater than 22.7 mg/L. Sax's Handbook According to handbook data the acute inhalation LC50 of the substance to mice is 27 g/m³. Acute Dermal Toxicity Food and Chemical Toxicology According to information in secondary literature, the acute dermal LD50 of the substance to the rabbit is in excess of 5000 mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f6f1c22-525d-4731-92ca-e87efb5ffca0/documents/ab47711f-bdd2-417d-966d-547365717f1b_98afa121-9336-4aa9-952a-b28dfd7c23a9.html,,,,,, 1-methyl-2-pyrrolidone,872-50-4," In the dietary combined subchronic and neurotoxicity study (90-day with 4 week recovery, rat) the NOAEL was 169 and 217 mg/kg bw/day for males and females, respectively (corresponding to 3,000 ppm). This finding was supported by several reliable studies in rats, mice and dogs. No target organ was identified (Haskell Lab., 1995). The NOAEC for systemic toxicity and local irritation was 500 mg/m³ air (125 ppm) based on the results of a repeated inhalation exposure to a liquid NMP aerosol (90-day with 4-week recovery, rat). At 3,000 mg/m³ air, cellular depletion was observed in the testes at the end of the treatment and recovery periods (BASF SE, 1994). In the key study for the dermal route of exposure (20-day, rabbit) a NOAEL for systemic toxicity of 826 mg/kg bw/day was derived, while for local skin irritation no NOAEL could be obtained. No target organ for systemic toxicity was identified (Ind. Biol. Res. Lab., 1963). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6ec0d64-26ed-4e3f-9e47-3e6595a6f200/documents/IUC5-4a9c3c9c-64e7-4cda-8b58-9ec93d333256_be7ec1a3-a544-4d10-9e0d-5fc7509d5546.html,,,,,, 1-methyl-2-pyrrolidone,872-50-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6ec0d64-26ed-4e3f-9e47-3e6595a6f200/documents/IUC5-4a9c3c9c-64e7-4cda-8b58-9ec93d333256_be7ec1a3-a544-4d10-9e0d-5fc7509d5546.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,826 mg/kg bw/day,,rabbit 1-methyl-2-pyrrolidone,872-50-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6ec0d64-26ed-4e3f-9e47-3e6595a6f200/documents/IUC5-4a9c3c9c-64e7-4cda-8b58-9ec93d333256_be7ec1a3-a544-4d10-9e0d-5fc7509d5546.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,169 mg/kg bw/day,,rat 1-methyl-2-pyrrolidone,872-50-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6ec0d64-26ed-4e3f-9e47-3e6595a6f200/documents/IUC5-4a9c3c9c-64e7-4cda-8b58-9ec93d333256_be7ec1a3-a544-4d10-9e0d-5fc7509d5546.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat 1-methyl-2-pyrrolidone,872-50-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6ec0d64-26ed-4e3f-9e47-3e6595a6f200/documents/IUC5-4a9c3c9c-64e7-4cda-8b58-9ec93d333256_be7ec1a3-a544-4d10-9e0d-5fc7509d5546.html,Repeated dose toxicity – local effects,inhalation,NOAEC,500 mg/m3,adverse effect observed,rat 1-methyl-2-pyrrolidone,872-50-4," The LD50/LC50 values derived from the key studies were: LD50 (oral, rat) 4150 mg/kg bw, similar to OECD 401, Ansell and Fowler, 1988; LC50 (inhalation, rat) > 5100 mg/m³, OECD 403, 1988; LD50 (dermal, rat) > 5000 mg/kg bw, OECD 402, 1984. Based on these results, NMP is of low acute toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6ec0d64-26ed-4e3f-9e47-3e6595a6f200/documents/IUC5-badaa529-102b-41e5-b150-37d69f660464_be7ec1a3-a544-4d10-9e0d-5fc7509d5546.html,,,,,, 1-methyl-2-pyrrolidone,872-50-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6ec0d64-26ed-4e3f-9e47-3e6595a6f200/documents/IUC5-badaa529-102b-41e5-b150-37d69f660464_be7ec1a3-a544-4d10-9e0d-5fc7509d5546.html,,oral,LD50,"4,150 mg/kg bw",no adverse effect observed, 1-methyl-2-pyrrolidone,872-50-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6ec0d64-26ed-4e3f-9e47-3e6595a6f200/documents/IUC5-badaa529-102b-41e5-b150-37d69f660464_be7ec1a3-a544-4d10-9e0d-5fc7509d5546.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, 1-methyl-2-pyrrolidone,872-50-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6ec0d64-26ed-4e3f-9e47-3e6595a6f200/documents/IUC5-badaa529-102b-41e5-b150-37d69f660464_be7ec1a3-a544-4d10-9e0d-5fc7509d5546.html,,inhalation,discriminating conc.,"5,100 mg/m3",no adverse effect observed, Methyl ricinoleate,141-24-2," LD50 (rat, oral, OECD 401) > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4aea692-a986-4589-9bf3-5cc425761000/documents/19f0309e-0b5b-47aa-9915-0b84ff2c63bc_914f0d11-ee0c-41a5-8575-1c9a5036cdc0.html,,,,,, "Resin acids and Rosin acids, Me esters",68186-14-1," Information is available on the oral repeated dose toxicity of Rosin esters (simple, linear, and bulky). No treatment-related or biologically relevant findings were apparent in rats following oral sub-chronic dietary exposure to Resin acids and rosin acids, esters with glycerol, Resin acids and rosin acids, esters with ethylene glycol, Resin acids and rosin acids, esters with triethylene glycol, Resin acids and rosin acids, hydrogenated, esters with glycerol and Resin acids and rosin acids, hydrogenated, esters with pentaerythritol. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97e0652b-4e66-4036-a58b-aecec2e866c1/documents/ece01948-e0ce-41fb-ac7a-188a2b0737e3_3389ffe3-84a1-4bae-8e0f-0444290b89b9.html,,,,,, "Resin acids and Rosin acids, Me esters",68186-14-1,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97e0652b-4e66-4036-a58b-aecec2e866c1/documents/fb782f2f-b258-4a07-9720-e4941740ef4c_3389ffe3-84a1-4bae-8e0f-0444290b89b9.html,,,,,, "Resin acids and Rosin acids, Me esters",68186-14-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97e0652b-4e66-4036-a58b-aecec2e866c1/documents/fb782f2f-b258-4a07-9720-e4941740ef4c_3389ffe3-84a1-4bae-8e0f-0444290b89b9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, Me esters",68186-14-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97e0652b-4e66-4036-a58b-aecec2e866c1/documents/fb782f2f-b258-4a07-9720-e4941740ef4c_3389ffe3-84a1-4bae-8e0f-0444290b89b9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl stearate,112-61-8,"All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air.While no reliable acute dermal toxicity studies are available, the picture of all available data is consistent supporting also a low level of dermal toxicity for the category of fatty acid methyl esters. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08575d5c-c52c-4c6b-bad0-90a23799d21d/documents/IUC5-e45e906a-d89f-4e4d-a34d-44793052573a_0c61e5cd-7f56-4550-8bc3-d3893334e805.html,,,,,, "1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane",17928-28-8," In the key 90-day repeated oral toxicity study, conducted according to OECD TG 408 and in compliance with GLP, the concluded NOAEL for males was 20 mg/kg bw/day based on pigment deposition in bile duct at higher doses. No such effect was seen in females and the concluded NOAEL for females was the highest dose tested, 750 mg/kg bw/day (Charles River, 2019). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f57599ff-6ecb-4559-9006-7f5c865c641f/documents/3fb82647-c92c-4ee9-b36e-0812436fa0dc_220ec9a4-1e83-449c-8111-ef363688d88f.html,,,,,, "1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane",17928-28-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f57599ff-6ecb-4559-9006-7f5c865c641f/documents/3fb82647-c92c-4ee9-b36e-0812436fa0dc_220ec9a4-1e83-449c-8111-ef363688d88f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane",17928-28-8," The key study for acute oral toxicity reports an LD50 value of >2000 mg/kg bw in rat, conducted according to a protocol equivalent to current OECD guideline but not in compliance with GLP (Haruna 2001). In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5.2) does not need to be conducted as reliable data via the oral and dermal routes are available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f57599ff-6ecb-4559-9006-7f5c865c641f/documents/6f00db9e-7c38-4c16-ab2f-754f016c7095_220ec9a4-1e83-449c-8111-ef363688d88f.html,,,,,, "1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane",17928-28-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f57599ff-6ecb-4559-9006-7f5c865c641f/documents/6f00db9e-7c38-4c16-ab2f-754f016c7095_220ec9a4-1e83-449c-8111-ef363688d88f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl undec-10-enoate,111-81-9,"A read-across from the 90-days repeated dose subchronic toxicity study on the structural analogue sodium salt undecylenic acid is being proposed. This read-across is based on the following justification.Referring to ECHA's ""Guidance on information requirements and chemical safety assessment - Chapter R.6: QSARs and grouping of chemicals"", endpoint information is read-across from a structural analogue. A structural analogue is a source chemical whose physico-chemical and toxicological properties are likely to be similar to the target chemical as a result of structural similarity. The similarity may be based on a common precursor and/or breakdown product, that results via physical or biological processes (metabolic pathway similarity). This is used to examine related chemicals, such as acid/ester/salt.Since the target chemical methyl-10-undecenoate is the methyl ester of the source chemical undecylenic acid, read-across between the two substances based on structural analogy therefore technically is possible. The scientific justification for the read-across of the study on oral repeat dose toxicity from undecylenic acid to methyl-10 –undecenoate is based on the similiar behaviour of the two substances observed during the six in-vivo studies on acute effects : - Acute oral toxicity: methyl-10 -undecenoate is classified as category 4, which is the lowest toxicity category. Since the LD50 of methyl-10 -undecenoate (1563 mg/kg) still is in the same order of magnitude compared to the LD50 of undecylenic acid (> 2000 mg/kg), the observed slight differences of the acute oral toxic effect should be insignificant in a repeated dose toxicity study. - Acute dermal toxicity, and skin sensitization: both substances with the same results ""not classified"".- Acute inhalative toxicity: methyl-10 –undecenoate is classified as category 4, which is the lowest toxicity category ... ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/abddd294-dd6f-4e45-9692-41e887ebd589/documents/IUC5-2a71cdc3-556c-4d2b-a50a-423a505ca335_f62ce46f-e7d6-4938-a436-fa6b45191d19.html,,,,,, Methyl undec-10-enoate,111-81-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/abddd294-dd6f-4e45-9692-41e887ebd589/documents/IUC5-2a71cdc3-556c-4d2b-a50a-423a505ca335_f62ce46f-e7d6-4938-a436-fa6b45191d19.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,, Methyl undec-10-enoate,111-81-9,"Acute oral : a study according to GLP guideline study (NF T03-021), LD50 = 1563 mg/kg bw (males and females)Acute dermal : a study according GLP guideline study (OECD 402), LD0 > 2000 mg/kg bw (males and females)Acute inhalation : a study according GLP guideline study (OECD 403), LD50 = 3.76 mg/l = 3.76 g/m3 (males and females) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abddd294-dd6f-4e45-9692-41e887ebd589/documents/IUC5-8c8af806-06db-42e4-81e2-577769346163_f62ce46f-e7d6-4938-a436-fa6b45191d19.html,,,,,, Methyl undec-10-enoate,111-81-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abddd294-dd6f-4e45-9692-41e887ebd589/documents/IUC5-8c8af806-06db-42e4-81e2-577769346163_f62ce46f-e7d6-4938-a436-fa6b45191d19.html,,oral,LD50,"1,563 mg/kg bw",adverse effect observed, Methyl undec-10-enoate,111-81-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abddd294-dd6f-4e45-9692-41e887ebd589/documents/IUC5-8c8af806-06db-42e4-81e2-577769346163_f62ce46f-e7d6-4938-a436-fa6b45191d19.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Methyl undec-10-enoate,111-81-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abddd294-dd6f-4e45-9692-41e887ebd589/documents/IUC5-8c8af806-06db-42e4-81e2-577769346163_f62ce46f-e7d6-4938-a436-fa6b45191d19.html,,inhalation,LC50,"3,760 mg/m3",adverse effect observed, Methyl valerate,624-24-8,"Acute toxicity: via oral route   OECD TG 423, oral, LD50 > 2000 mg/kg body weight.   Acute toxicity: via dermal route   OECD TG 402, dermal, LD50 > 2000 mg/kg body weight.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e5a9594-0025-49b3-8536-7ef85cd48eb6/documents/IUC5-28eec0c3-661e-4848-b938-1b5503285b94_eeb936f4-e85a-4a52-aad0-4f385c8ac86a.html,,,,,, Methyl valerate,624-24-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e5a9594-0025-49b3-8536-7ef85cd48eb6/documents/IUC5-28eec0c3-661e-4848-b938-1b5503285b94_eeb936f4-e85a-4a52-aad0-4f385c8ac86a.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Methyl valerate,624-24-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e5a9594-0025-49b3-8536-7ef85cd48eb6/documents/IUC5-28eec0c3-661e-4848-b938-1b5503285b94_eeb936f4-e85a-4a52-aad0-4f385c8ac86a.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 1-phenylethyl acetate,93-92-5," The NOAEL for the 90-Day Repeated Dose Toxicity study on Gardenol dosed via the oral route was >= 150 mg/kg bw/day, the highest dose level in the study. The NOAEL for the supporting structurally similar analogue benzyl acetate was 250 mg/kg bw/day for females and 500 mg/kg bw/day for males according to a study performed in line with methodology considered to be equivalent or similar to OECD Guideline 408.   Repeated Dose Toxicity studies: Dermal and Inhalation: Data waivers have been submitted to address repeat dose toxicity via the dermal and inhalatory routes. Exposure via the oral route is considered to be the most likely route of exposure and sufficient repeat dose oral toxicity studies have been submitted. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd5328a9-0c56-4bdf-9255-e70e62926df1/documents/IUC5-12dc13ca-a378-4375-bec8-cf387a282380_d677db59-15fd-4656-bacb-070b3ab4900d.html,,,,,, 1-phenylethyl acetate,93-92-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd5328a9-0c56-4bdf-9255-e70e62926df1/documents/IUC5-12dc13ca-a378-4375-bec8-cf387a282380_d677db59-15fd-4656-bacb-070b3ab4900d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat 1-phenylethyl acetate,93-92-5,"ACUTE TOXICITY ORAL:The LD50 of 1-phenylethyl acetate was determined to be >5000 mg/kg according to a study performed in line with Federal Hazardous Substances Labelling Act: Hazardous Substances; US Department of Health, Education and Welfare, Food and Drug Administration.ACUTE TOXICITY: INHALATIONIn line with point 8.5.2, Column 2, Annex VIII of Regulation 1907/2006, an acute inhalation study does not need to be performed as the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. The acute toxicity endpoint has been addressed by assessing the toxicity via the oral and dermal routes which are more appropriate when considering the properties of this substance.ACUTE TOXICITY: DERMALThe LD50 of 1-phenylethyl acetate was determined to be >8 mL according to a study performed in line with Association of Food and Drug Officials of the United States, Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, 1959, pp 54-56. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd5328a9-0c56-4bdf-9255-e70e62926df1/documents/IUC5-c97eab9d-d2cb-4325-beef-3a71a7f88efb_d677db59-15fd-4656-bacb-070b3ab4900d.html,,,,,, 4-methylbenzyl alcohol,589-18-4," Oral (comparable to OECD 401), rat: LD50 = 3900 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00a4d730-b050-4b9e-b601-9ba2503a397b/documents/c575575f-1c7c-4afb-9ebc-fe13a2a3bb2d_b2dc1531-0bb7-4a3e-af92-1f050a234a78.html,,,,,, 4-methylbenzyl alcohol,589-18-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00a4d730-b050-4b9e-b601-9ba2503a397b/documents/c575575f-1c7c-4afb-9ebc-fe13a2a3bb2d_b2dc1531-0bb7-4a3e-af92-1f050a234a78.html,,oral,LD50,"3,900 mg/kg bw",adverse effect observed, 2-methylbutene,26760-64-5," The repeat dose toxicity of 2-methylbutene has been determined by testing of its main constituent, 2-methylbut-2-ene (2M2B), which produced some general systemic effects in rats following repeated exposure. These effects were slight and were most apparent in the high dose animals and only to a small extent in the mid-dose animals. The systemic No Observed Adverse Effect Concentration was 1665 mg/m3 (580 ppm). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8a3633e-182e-4532-9627-5589e717a5d2/documents/IUC5-ff8503f0-1763-4e37-8496-2df68e90bdc8_4aef848c-8e31-4b17-b261-e6808a45fe76.html,,,,,, 2-methylbutene,26760-64-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8a3633e-182e-4532-9627-5589e717a5d2/documents/IUC5-ff8503f0-1763-4e37-8496-2df68e90bdc8_4aef848c-8e31-4b17-b261-e6808a45fe76.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,665 mg/m3",,rat 2-methylbutene,26760-64-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8a3633e-182e-4532-9627-5589e717a5d2/documents/IUC5-ff8503f0-1763-4e37-8496-2df68e90bdc8_4aef848c-8e31-4b17-b261-e6808a45fe76.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"5,740 mg/m3",adverse effect observed,rat 2-methylbutene,26760-64-5,"Based on assessment of the available data for 2-methylbut-2-ene (2M2B), the oral LD50 of isoamylene is in the range of 1000 to 1700 mg/kg. The dermal LD50 is >2000 mg/kg. The 4-hour LC50 is >175,000 mg/m3. Inhalation of isoamylene can produce central nervous system depression, anaesthesia and/or asphyxiation that are reversible following cessation of exposures. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8a3633e-182e-4532-9627-5589e717a5d2/documents/IUC5-ac5fdd4b-191f-408a-98ba-a6834ec301ed_4aef848c-8e31-4b17-b261-e6808a45fe76.html,,,,,, 2-methylbutene,26760-64-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8a3633e-182e-4532-9627-5589e717a5d2/documents/IUC5-ac5fdd4b-191f-408a-98ba-a6834ec301ed_4aef848c-8e31-4b17-b261-e6808a45fe76.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, 2-(2-(4-methyl-3-cyclohexen-1-yl)propyl)cyclopentanone,95962-14-4," The Repeated dose 28-day oral toxicity study with NECTARYL by dietary administration in the rat, followed by a 14-day recovery period was performed in 2014 according to the OECD Guideline No. 407. Adverse Effect Level (NOAEL) for NECTARYL of 3000 ppm was established (corresponding to 285 and 274 mg NECTARYL/kg body weight/day, for males and females respectively). The objective of the study performed in 1989 according to the OECD Guideline No.410 was to evaluate the  toxicity of the test article  NECTARYL - LRG  1371  in the rat following dermal application for 4 weeks. The ""no observable toxic effect level"" was determined in this test conditions to be equal to 1 000 mg/kg. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/496337a9-cd7b-4f37-a1a1-cb436477194f/documents/03782abb-bbb8-4429-9dfe-30dc1abfe247_ce7bdbde-0e77-4e42-a856-7e2de81a0c84.html,,,,,, 2-(2-(4-methyl-3-cyclohexen-1-yl)propyl)cyclopentanone,95962-14-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/496337a9-cd7b-4f37-a1a1-cb436477194f/documents/03782abb-bbb8-4429-9dfe-30dc1abfe247_ce7bdbde-0e77-4e42-a856-7e2de81a0c84.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,274 mg/kg bw/day,,rat 2-(2-(4-methyl-3-cyclohexen-1-yl)propyl)cyclopentanone,95962-14-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/496337a9-cd7b-4f37-a1a1-cb436477194f/documents/03782abb-bbb8-4429-9dfe-30dc1abfe247_ce7bdbde-0e77-4e42-a856-7e2de81a0c84.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat 2-(2-(4-methyl-3-cyclohexen-1-yl)propyl)cyclopentanone,95962-14-4," Acute Oral Toxicity NECTARYL was tested to evaluate the acute toxicity following a single oral administration (limit test) in rats according to the Guideline No. 401 in 1989. From the results obtained under the experimental conditions employed, the LD0 by oral route, in the rat, of the test substance administered once only, as supplied, is greater than or equal to 2008 mg/kg. Acute Dermal Toxicity NECTARYL was tested to evaluate the acute toxicity following a single dermal administration (limit test) in rats according to the Guideline No. 402 in 1989. From the results obtained under the experimental conditions employed, the LD0 by dermal route, in the rat, of the test substance administered once only, as supplied, is greater than or equal to 2008 mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/496337a9-cd7b-4f37-a1a1-cb436477194f/documents/73de779b-bf05-4190-b5cc-dac88cc87f70_ce7bdbde-0e77-4e42-a856-7e2de81a0c84.html,,,,,, 2-(2-(4-methyl-3-cyclohexen-1-yl)propyl)cyclopentanone,95962-14-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/496337a9-cd7b-4f37-a1a1-cb436477194f/documents/73de779b-bf05-4190-b5cc-dac88cc87f70_ce7bdbde-0e77-4e42-a856-7e2de81a0c84.html,,oral,LD50,"2,008 mg/kg bw",no adverse effect observed, 2-(2-(4-methyl-3-cyclohexen-1-yl)propyl)cyclopentanone,95962-14-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/496337a9-cd7b-4f37-a1a1-cb436477194f/documents/73de779b-bf05-4190-b5cc-dac88cc87f70_ce7bdbde-0e77-4e42-a856-7e2de81a0c84.html,,dermal,LD50,"2,008 mg/kg bw",no adverse effect observed, 3-methylcyclopentadecan-1-one,541-91-3," Acute toxicity: oral: LD50 > 5000 mg/kg bw (in 2 studies; similar to OECD 401 in rats; rel.2, WoE) Acute toxicity: dermal: LD50 > 5000 mg/kg bw/day (similar to OECD 402 in rabbits, rel.2, S) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bb1f71e-3874-49ab-a696-054b2dc30151/documents/IUC5-fc11f130-56a2-4a0a-917d-c14ab6cf7906_0aa99836-9237-4c60-a1e2-9438e56b4882.html,,,,,, 3-methylcyclopentadecan-1-one,541-91-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bb1f71e-3874-49ab-a696-054b2dc30151/documents/IUC5-fc11f130-56a2-4a0a-917d-c14ab6cf7906_0aa99836-9237-4c60-a1e2-9438e56b4882.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 3-methylcyclopentadecan-1-one,541-91-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bb1f71e-3874-49ab-a696-054b2dc30151/documents/IUC5-fc11f130-56a2-4a0a-917d-c14ab6cf7906_0aa99836-9237-4c60-a1e2-9438e56b4882.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Methyl 3-oxo-2-pentylcyclopentaneacetate,24851-98-7,A 90-d study by oral route have been performed on the test material. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc41508b-baab-499a-a3fe-679d6a8947bf/documents/IUC5-2b7e8588-f763-4d07-8a59-af2693d8a559_68090cd5-7269-4158-aa2b-5887e5c7031f.html,,,,,, Methyl 3-oxo-2-pentylcyclopentaneacetate,24851-98-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc41508b-baab-499a-a3fe-679d6a8947bf/documents/IUC5-2b7e8588-f763-4d07-8a59-af2693d8a559_68090cd5-7269-4158-aa2b-5887e5c7031f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Methyl 3-oxo-2-pentylcyclopentaneacetate,24851-98-7,"Oral LD50 > 5 g/kg (US-FHSA), limit test in ratsOral LD50 ~ 10 g/kg (OECD 401), limit test in ratsOral LD50 < 10 g/kg, (OECD 401), limit test in ratsDermal LD50 > 5 mg/kg (U.S.- FHSA), limit test in rabbits Inhalation LC50 > 4.96 mg/l (OECD 403), limit test in rats ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc41508b-baab-499a-a3fe-679d6a8947bf/documents/IUC5-c1c300b5-2248-44c1-90b6-234af81e6a6a_68090cd5-7269-4158-aa2b-5887e5c7031f.html,,,,,, Methyl 3-oxo-2-pentylcyclopentaneacetate,24851-98-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc41508b-baab-499a-a3fe-679d6a8947bf/documents/IUC5-c1c300b5-2248-44c1-90b6-234af81e6a6a_68090cd5-7269-4158-aa2b-5887e5c7031f.html,,oral,LD50,"5,000 mg/kg bw",, Methyl 3-oxo-2-pentylcyclopentaneacetate,24851-98-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc41508b-baab-499a-a3fe-679d6a8947bf/documents/IUC5-c1c300b5-2248-44c1-90b6-234af81e6a6a_68090cd5-7269-4158-aa2b-5887e5c7031f.html,,dermal,LD50,"5,000 mg/kg bw",, Methyl 3-oxo-2-pentylcyclopentaneacetate,24851-98-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc41508b-baab-499a-a3fe-679d6a8947bf/documents/IUC5-c1c300b5-2248-44c1-90b6-234af81e6a6a_68090cd5-7269-4158-aa2b-5887e5c7031f.html,,inhalation,LC50,"4,930 mg/m3",, "6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol",119-47-1,"Several repeated dose toxicity studies are available for the test substance 6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol. Comparable effects were seen in subacute, subchronic and chronic toxicity rodent studies. Effects on body weight gain, increases in liver weights and adverse effect on reproduction organs were noted (effects on reproduction organs see discussion chapter toxicity to reproduction). In the subchronic feeding study with dogs effects on the liver were noted at 330 ppm (ca. 11 mg/kg bw/day). However, the number of dogs used is very limited and thus the study is used only for supporting reasons. Based on the findings from the several rodent toxicity studies a NOAEL of 12.7 mg/kg bw and day is used for DNEL calculation, which based on a suppression of body weight gain, increase in liver weight, decrease in testis weight, and histopathological lesions in the testis and the epididymis observed at 42.3 mg/kg bw/ day in the chronic feeding study with Wistar rats (Takagi 1994). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a285195-bbee-4055-91aa-c8a09199037a/documents/IUC5-a8c1deff-b5fb-4875-baa2-a4e853e42acb_439bfbf9-4442-435d-9b4e-8160bc41049e.html,,,,,, "6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol",119-47-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a285195-bbee-4055-91aa-c8a09199037a/documents/IUC5-a8c1deff-b5fb-4875-baa2-a4e853e42acb_439bfbf9-4442-435d-9b4e-8160bc41049e.html,Chronic toxicity – systemic effects,oral,NOAEL,12.7 mg/kg bw/day,,rat "6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol",119-47-1,"The acute dermal and oral toxicity of the test substance 6,6’-di-tert-butyl-2,2’-methylendi-p-cresol (DBMC) is very low, indicated by LD50 values greater than 5000 mg/kg. The acute oral LD50 value in rats is greater than 5000 mg/kg bw mg/kg (Takagi 1994) and the dermal LD50 value in rabbits is greater than 10000 mg/kg bw (American Cyanamid Company 1965). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a285195-bbee-4055-91aa-c8a09199037a/documents/IUC5-6d8d9d78-f108-4f83-9d83-b2d2352ada97_439bfbf9-4442-435d-9b4e-8160bc41049e.html,,,,,, "6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol",119-47-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a285195-bbee-4055-91aa-c8a09199037a/documents/IUC5-6d8d9d78-f108-4f83-9d83-b2d2352ada97_439bfbf9-4442-435d-9b4e-8160bc41049e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "6,6'-di-tert-butyl-2,2'-methylenedi-p-cresol",119-47-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a285195-bbee-4055-91aa-c8a09199037a/documents/IUC5-6d8d9d78-f108-4f83-9d83-b2d2352ada97_439bfbf9-4442-435d-9b4e-8160bc41049e.html,,dermal,LD50,"10,000 mg/kg bw",no adverse effect observed, "4,4'-methylenediphenyl diisocyanate",101-68-8,"Description of Key information The test substance is part of a category approach of methylenediphenyl diisocyanates (MDI) with existing data gaps filled according to ECHA guidance on Read Across (ECHA, 2017).  The read-across category justification document is attached in IUCLID section 13 and summarized below in Additional Informaiton.  Data-gaps in this endpoint is satisfied by weight of evidence and read across from valid repeated dose toxicity studies for the inhalation route. Reliable repeated dose inhalation data in animals is available for the boundary substances (4,4’-MDI, pMDI and 4,4’-MDI/DPG/HMWP). The chronic repeated dose toxicity study (Reuzel et al. 1994, reliability 2) performed with pMDI is a guideline study (OECD 451). In addition, valid sub-chronic and sub-acute repeated dose toxicity studies are available  for pMDI (Reuzel et al. 1994, Kilgour et al. 2002, reliability 2). For the 4,4’-MDI a valid chronic inhalation toxicity study is available (Hoymann et al. 1995, reliability 2) and a limited documented sub-chronic inhalation toxicity study (Heinrich et al. 1991, reliability 4). For the boundary substance 4,4’-MDI/DPG/HMWP a sub-acute toxicity study is available (Ma-Hock, 2021, reliability 1).   Proposed Testing: To support this weight of evidence and read across approach additional repeated dose toxicity testing is planned. It is considered to perform a sub-chronic inhalation toxicity study (OECD 413) with boundary substance 4,4’-MDI/DPG/HMWP. Additional, combined Repeated Dose Toxicity studies with Reproductive/ developmental Toxicity Screening tests (OECD 422) will be performed on 9 substances representing all sub-groups and key structural/chemical characteristics (see overview attached in Annex 27 in Chapter 13). These screening studies will confirm the proposed MoA on repeated dose toxicity or identify substances that may require additional testing.   Available information: Several sub-acute, sub-chronic and chronic studies have been performed on 4,4’-MDI, pMDI and 4,4’-MDI/DPG/HMWP and are described in Category justification document in Chapter 13 . A repeated dose dermal toxicity study was performed in rabbits with pMDI (Wazeter et al., 1964a) but since this only has fourteen days of treatment and only slight local skin irritants effects were observed this is omitted from this chapter, but rather described in chapter addressing skin irritation. As with the acute studies, in all repeated dose studies, toxic effects were limited to the site of contact with no systemic effects observed distant from the portal of entry. Key repeated dose studies days are described below:  The ‘Monomeric MDI’ subgroup In a subchronic inhalation study with 4,4’-MDI, female Wistar rats were exposed to concentrations of MDI of 0, 0.3, 1 or 3 mg 4,4’-MDI/m3 for 18 hours a day on 5 days a week for 13-weeks. Reduced body weight gains and an increase in relative lung weights were found at 1 mg/m3 and above. At and above this concentration infiltration of mononuclear cells, goblet cell hyperplasia, erosion of the respiratory epithelium in the upper respiratory tract, hyperplasia of the bronchus-associated lymphatic tissue and inflammatory changes of the lung were additionally observed. At 3 mg/m3 there was an increase in the total cell count and proportion of granulocytes and lymphocytes, a decrease in the proportion of macrophages in the bronchoalveolar lavage fluid, an increase in protein, β-glucuronides and lactate dehydrogenase, and changes in lung function. No effects were observed at 0.3 mg/m3 (Heinrich et al., 1991). A subsequent chronic inhalation study (Hoymann et al., 1995) was conducted with 4,4’-MDI. Female Wistar rats were exposed to 0.23, 0.70 or 2.05 mg 4,4’-MDI/m³ aerosols for 17 hours/day, 5 days /week for up to 24 months. Essentially, a dose-dependent impairment of the lung function in terms of an obstructive-restrictive malfunction with diffusion disorder, increased lung weights, an inflammatory reaction with increased appearance of lymphocytes in the lung in the high dose group as a sign of specific stimulation of the immune system by MDI, an intermediately retarded lung clearance in the high dose group as well as dose-dependent interstitial and peribronchiolar fibrosis, alveolar bronchiolisations and a proliferation of the alveolar epithelium, which was classified as preneoplastic, as well as a bronchiolo-alveolar adenoma were identified. The LOAEC for the female rat was identified as 0.23 mg/m3 based on minor histopathological pulmonary lesions after long-term inhalation of 4,4'-MDI aerosols.  A comparison of the pulmonary effects described in female rats from the two chronic studies, one with 4,4’-MDI and the other with pMDI, was published by Feron et al. (2001). To assist the comparison and account for the lower proportion of mMDI in pMDI, the authors normalized the different MDI doses to total inhalation exposures calculated as 559; 1,972; 2,881; 6,001; 17,575 and 17,728 mg mMDI.h/m3. The major pulmonary effects in the two studies were characterized by hyperplasia, interstitial fibrosis and a low incidence of bronchiolo-alveolar adenoma, the latter occurring in the high exposure groups of both studies (i.e. total inhalation exposures of 17,728 and 17,575 mg.h/m3). Both studies also reported the presence of particle-laden macrophages predominantly in the alveoli close to the alveolar ducts which in some cases, particularly in high dose groups, were associated with areas of fibrosis. There was a clear quantitative dose response in both studies with the lowest dose of 559 mg mMDI.h/m3 from the study reported by Reuzel et al. (1994a) being described as the no-observed-adverse-effect-level (NOAEL) Feron et al. (2001) also suggested that the mild histopathological changes seen in the low exposure animals (0.23 mg/m3) in the Hoymann et al. (1995) study, would not have occurred if the exposure had been for six hours/day. An exposure of 0.2 mg/m3 over a six-hour period was judged to be the NOAEL in both studies. Overall, the analysis concluded that both studies showed similar qualitative responses to exposures to pMDI or 4,4’-MDI when compared on the basis of mMDI content..  The ‘Oligomeric MDI’ subgroup In a subacute inhalation study by Kilgour et al. (2002), female Alpk:APfSD rats were exposed to pMDI aerosol at  concentrations of 0, 1.0, 4.0 and 10 mg pMDI/m3, for 6 hours/day, 5 days/week, for  28 days, a 30-day recovery group was included. No clinical signs were noted during exposure and recovery phase. Body weights in all groups were comparable to controls throughout exposure and recovery periods. Lung weights were increased in animals exposed to 10 mg/m3 at the end of the exposure period, although this had returned to control values by day 30 post-exposure. Lung weights of all other treated groups were in the range of the control group. A dose-dependent influx of inflammatory cells, total protein levels and increase in enzyme activities indicated an inflammatory reaction. A statistically significant increase in both the total number of cells counted and alveolar macrophages in lavage fluid was noted at 10 mg/m3, and a slight (but not statistically significant) following exposure to 4 mg/m3. The polymorphonulear leukocytes (PMNs) and lymphocyte/other cells showed statistically significant, concentration-related increases in cell counts following exposure to 4 or 10 mg/m3 pMDI. At the end of the recovery phase, cell counts in exposed animals had returned to normal. Animals of the exposure groups 4 and 10 mg/m3 showed an increase of macrophages containing vacuoles (foamy macrophages), whereas the 1 mg/m3 group was in the range of the control animals. At the end of the recovery period few macrophages vacuoles were still discernable. In animal exposed to 10 mg/m3 pMDI a statistically significant increase in total protein and alkaline phosphatase activity was noted in lavage fluid at the end of exposure, whereas lactate dehydrogenase and N-acetyl glucosaminidase (NAG) activities were not increased. All other treated groups in the main study and all groups at the end of the recovery phase showed values similar to controls. A transient increase in phospholipids concentration was noted in the lavage fluid from animals exposed to 10 mg/m3 pMDI after exposure, no differences from control values were seen at the end of the recovery phase. In all exposure groups a statistically significant concentration-related increase in BrdU labelling index in terminal bronchioles were seen; a similar increase in centro-acinar alveoli were found in animals exposed to 4 and 10 mg/m3 pMDI. At the end of the recovery phase, labelling indices were similar to control values at all concentrations. No macroscopic abnormalities were noted. Histopathology of the lung showed in animals exposed to 10 mg/m3 pMDI an increase in bronchiolitis and thickening of the centro-acinar region, interstitial thickening at the acinar junctions, and accumulations of alveolar macrophages containing yellow pigment in the cytoplasm. In animals exposed to 4 mg/m3 pMDI 1/5 animals showed thickening of the centro-acinar region and bronchiolitis and 1/5 animals exposed to 1 mg/m3 pMDI showed bronchiolitis. After the recovery phase, alveolar macrophages containing a yellow pigment were present in the interstitium in all animals that had been exposed to 10 mg//m3 pMDI but were absent in animals exposed to 1 or 4 mg/m3 pMDI. In addition, 1/5 animals exposed to 10 mg/m3 pMDI still had bronchiolitis and centro-acinar thickening, but at a reduced severity and distribution to that seen in the main study. Ultrastructural findings suggest a perturbation of surfactant homeostasis by exposure to pMDI which is supported by the small increase in measured phospholipids and observation of foamy macrophages. Animals exposed to 10 mg/m3 pMDI showed a slight thickening of the interstitial alveolar wall in 3/5 animals. The thickening in the centro-acinar region was due to thickening of the interstitium, which partly attributable to the absorption of alveolar macrophages and partly due to excess collagen. Compound -related increases in the levels of surfactant were noted in the alveolar macrophages and lumina. In the alveolar macrophages, minimal to slight increases in lamellar surfactant were associated with minimal and moderate increases in amorphous surfactant in animals exposed to 10 mg/m3 pMDI.  In the alveolar lumina, minimal to moderate increase in cell debris were noted in animals exposed to 10 or 4 mg/m3 pMDI. Associated with these increases in cell debris were increases in the amount of crystalline and lamellar surfactant. At 1 mg/m3 there was evidence of effect on surfactant homeostasis, with small increase in number and size of type II cell lamellar bodies and similar increases in  amorphous, crystalline and lamellar surfactant in the  alveolar lumina, which was seen as an adaptive response to exposure to low levels of irritant aerosol. Based on findings of histopathology, bronchiolitis noted at 1 mg/m3 and evidence of effect on surfactant homeostasis at 1 mg/m3, NOAEC could not be defined and the LOAEC was set at 1 mg/m3 pMDI.   In a subchronic inhalation study (SC1) by Reuzel et al. (1994b) (original report Reuzel et al. (1985)) Wistar rats were exposed to pMDI aerosol at concentrations of 0, 0.35, 1.4 and 7.2 mg pMDI/m3, for 6 hours/day, 5 days/week over a period of 13 weeks. Transient slight growth retardation was observed in male rats exposed to 7.2 mg/m3 air. Haematology, blood chemistry and urinalysis did not show treatment-related effects. There were no significant differences in organ weights between the test and control groups. Gross examination at autopsy did not reveal changes which could be ascribed to the test substance. Histopathological examination revealed yellow material (possibly polyurea originated from test material) in the respiratory tract of rats exposed to 7.2 mg/m3. Under the conditions of this test no clear NOAEC was determined. In an associated second subchronic study (SC2) by Reuzel et al. (1994b) (original report by (Reuzel et al., 1986)), Wistar rats were exposed to higher aerosol concentrations of 4.1, 8.4 and 12.3 mg pMDI /m3 air for 3-months. Severe respiratory distress was observed in rats exposed to 12.3 mg/m3 with 11 males and 4 females dying during the exposure period. Significantly less severe signs were seen in rats exposed to 8.4 mg/m3. This study demonstrated adverse effects in the lungs and nasal cavity at levels of 4.1 mg/m3 and above and included histological effects in the lungs (increase in alveolar macrophages and interstitial macrophage infiltration) and in the mediastinal lymph nodes (macrophages with yellowish inclusions). At 8.4 mg/m³ and above increased relative lung weights, partially reversible damage to the olfactory epithelium and basal cell hyperplasia were observed.   In a combined chronic toxicity and carcinogenicity key study (Reuzel et al., 1990; Reuzel et al., 1994a) conducted according to OECD Guideline 453 rats were exposed for 6 hours/day, 5 days/week for one year (satellite groups) or two years (main groups) to aerosol concentrations of 0, 0.2, 1.0 or 6.0 mg pMDI /m3 (analytical concentrations: 0, 0.19, 0.98, 6.03 mg/m3). The effect of chronic exposure of rats to respirable pMDI aerosol was confined to the respiratory tract. The compound-related changes were found in the nasal cavity, the lungs and the mediastinal lymph nodes, and to some degree they were already present after one year of exposure. Histopathology of the organs/tissues investigated showed that exposure to 6.0 mg/m3 over two years was related to the occurrence of pulmonary tumors in males (6 adenomas and 1 adenocarcinoma) and females (2 adenomas). In this two-year rat study, the NOAEC was 0.2 mg/m3 for the repeated dose toxicity of pMDI. The LOAEC was set at 1.0 mg/m3.   The ‘MDI and its reaction products with glycols’ subgroup Pre-liminary results are available for a subacute inhalation study (Ma-Hock, 2021) which was conducted according to OECD 412 on 4,4’-MDI/DPG/HMWP. This study was designed as closely as possible to the study described above by Kilgour et al. (2002) on pMDI to generated comparable data on 2 category boundary substances.  A qualitative and quantitative comparison between these studies will be described in more detail in the category justification document attached to this dossier.   Male and female Wistar rats (7 animals per sex and exposure group) were exposed to 4,4’-MDI/DPG/HMWP liquid aerosol at  concentrations of 0, 1.0, 4.0 and 10 mg/m3 (analytical conc.: 0, 1.0, 3.9 and 9.8 mg/m3), for 6 hours/day, 5 days/week, for  4 weeks (main study). To evaluate the reversibility of effects, 28-day recovery groups were included (recovery control group and 10 mg/m3 exposure group). No mortality was observed throughout the study. During the exposure period clinical signs like respiration sound and piloerection were noted in animals exposed to 10 mg/m3 and one animal exposed to 4 mg/m3. In all other animals, no clinical signs were observed during the exposure period. No clinical signs were observed during the recovery period. Body weights of males exposed to 10 mg/m3 was slightly lower throughout the exposure period but were in the range of the concurrent control at the end of the recovery period. All other groups were comparable throughout exposure and recovery period. A significant increase in mean relative lung weights was observed in males and females of the 10 mg/m3 exposure group, although this had returned to control values at the end of the recovery period. Regarding clinical chemistry, one female of exposure group 4 mg/m3 and 2 females of exposure group 10 mg/m3 (main study) showed an increase in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activities. These effects were regarded as caused by the implant of Alzet osmotic minipumps, thus regarded as treatment related but not substance related effect. All other changes in clinical chemistry observed in exposed animals were regarded as incidental and not treatment related. In animals exposed to 10 mg/m3 a lymphocytic-monocytic inflammation was observed indicated by increased total cell counts as well as absolute and relative lymphocyte and monocyte counts. This type of inflammation was confirmed by marginal, non-relevant increases of lactate dehydrogenase (LDH BAL) and alkaline phosphatase (ALP BAL) activities, but relevantly, slight increases of γ-glutamyl transferase (GGT BAL) activities among these individuals. In BAL of rats exposed to 10 mg/m3 increases of high total protein levels were observed. At the end of the recovery period total protein levels and enzyme activities and cell counts had returned to control levels. Treatment-related histopathological findings were observed in lungs, trachea, larynx, tracheobronchial lymph nodes and mediastinal lymph nodes in male and female animals. Interstitial inflammation of the terminal bronchi was observed in animals exposed to 4 mg/m3 and 10 mg/m3. Hypertrophy/hyperplasia of large, medium and terminal bronchi were observed in animals exposed to 4 mg/m3 and 10 mg/m3, which was associated with an increase in cell proliferation, indicated as a significant increase in BrdU labeling indices. A statistically significantly increased cell proliferation was also observed in animals exposed to 1 mg/m3 in large, medium and terminal bronchi. In alveoli there was a trend towards increased cell proliferation, however there was no dose-response relationship, statistically significance was only seen in males exposed to 10 mg/m3. Pneumocytes type II cells showed minimal proliferation in few animals of the 4 mg/m3 and 10 mg/m3 exposure group. Interstitial inflammation of alveoli was noted in males of the 4 mg/m3 and 10 mg/m3 exposure groups. In the alveolar lumina, neutrophilic infiltration was found occasionally. Debris was seen in one male of the 4 mg/m3 exposure group in alveolar lumina consisting of fragments of cells. Alveolar macrophage accumulation was seen with increased severity in males and females exposed to 10 mg/m3. A minimal increase in alveolar macrophages was still present in females at the end of the recovery period. Macrophages with foamy cytoplasm (foamy macrophages) were observed in males of the 4 mg/m3 and 10 mg/m3 exposure groups and in females exposed to 10 mg/m3. Epithelial alteration in the larynx was noted with increased incidence and severity in treated animals and was characterized by a focal, ventrally located change of the epithelium from cuboidal to focally flattened cells and was noted with increased incidence and severity in treated animals. Lymphocyte infiltration was seen in the submucosa in treated animals. The trachea epithelium on the tip of the carina was changed from its normal cuboidal, ciliated appearance to a single layer of flattened cells with loss of cilia in treated animals. Hyperplasia of the trachea epithelium was seen in males exposed to 4 mg/m3 and 10 mg/m3 and females exposed to 10 mg/m3. Beneath the epithelium, there was an increased infiltration of lymphocytes in single animals. A diffuse enlargement of mediastinal and tracheobronchial lymph nodes was seen in treated animals. The histopathological changes noted after termination of exposure were mostly reversible. An increased incidence of minimal alveolar macrophage accumulation was still observed at the end of the recovery period in treated females. Increased cell proliferation in alveoli was still observed in treated males. No other treatment related findings were observed at the end of the recovery period.   In summary, substance-related systemic effect was not observed. Under the current study conditions, the no observed adverse effect level (NOAEL) for systemic toxicity was 10 mg/m³. The NOAEL for local toxicity could not be established due to the slight changes in labeling indices present at 1 mg/m³ (Ma-Hock, 2021).   Human information A large dataset is available in human epidemiological and case studies for chronic exposure to diisocyanates in the workplace and reported effects are limited to respiratory system. Effects associated with respiratory sensitization are described in chapter sensitization and potential carcinogenicity is described in carcinogenicity chapter. In general, long term exposure to MDI substances can result in non-immunological decreases in lung function and other respiratory symptoms associated with chronic irritation. Interpretation of many of these studies is confounded by simultaneous exposure to TDI and inaccurate exposure data. Despite these limitations, pMDI concentrations as low as 87 ppb (0.9 mg/m3) were shown to correlate with deterioration in lung function whereas when exposures were below a maximum concentration of 20 ppb (0.2 mg/m3), no significant changes in lung spirometry was generally observed (DFG, 2008). The frequency of respiratory complaints was not significantly increased when exposure levels were below 10 ppb (0.1 mg/m3) (DFG, 2008).     Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint: No system toxicity up to the highest dose group tested   Inhalation is the most appropriate route of exposure for assessing occupational risk of substances of the MDI category in humans. Repeated dose studies are available for the three boundary substances , GLP compliant study on both 4,4’-MDI and pMDI with reliability 2, conducted according to OECD Guideline 453 (combined chronic toxicity/carcinogenicity studies) and two 28 day studies on pMDI and 4,4’-MDI/DEG/HMWP. In all repeated dose studies, toxic effects were limited to the site of contact with no systemic effects observed distant from the portal of entry, which is in line with the discussed MoA of MDI toxicity (see category justification document).   Repeated dose toxicity: inhalation - local effects (target organ) respiratory: respiratory tract   ​ Inhalation is the most appropriate route of exposure for assessing occupational risk of substances of the MDI category in humans. Repeated dose studies are available for the three boundary substances, GLP compliant study on both 4,4’-MDI and pMDI with reliability 2, conducted according to OECD Guideline 453 (combined chronic toxicity/carcinogenicity studies) and two 28 day studies on pMDI and 4,4’-MDI/DEG/HMWP. Consistent with the hypothesized MoA proposed (see category justification document) for these substances the primary health effect following inhalation exposure is local irritation within the respiratory tract without significant systemic exposure or toxicity. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b1ab441-bdc5-48dd-98e9-0525e10edbd2/documents/3c2aa6cb-5926-4781-bf26-ff77265a67f0_8127b847-aa87-4837-a390-3383d641354f.html,,,,,, "4,4'-methylenediphenyl diisocyanate",101-68-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b1ab441-bdc5-48dd-98e9-0525e10edbd2/documents/3c2aa6cb-5926-4781-bf26-ff77265a67f0_8127b847-aa87-4837-a390-3383d641354f.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1 mg/m3,adverse effect observed, "4,4'-methylenediphenyl diisocyanate",101-68-8,"Data gap filling for the acute inhalation toxicity endpoint is achieved using the category approach according to ECHA guidance on read-across (ECHA, 2017c). For this endpoint, all effects are consistent with the hypothesized MoA and direct electrophilic reactions of NCO with biological nucleophiles. Modified MDI substances contain different higher molecular weight constituents, and all have in common a high content of bioaccessible low molecular weight MDI constituents responsible for presenting NCO reactivity, scenario 4 or 6 according to the RAAF considered as most appropriate due to a common mechanism. Selection between scenario 4 and 6 depends essentially upon the presence of variation in the properties i.e. magnitude of effect. Since it has been demonstrated that the bioaccessible low molecular weight MDI constituents are responsible for presenting NCO reactivity, and the higher molecular weight MDI constituents do not contribute to the observed toxicity it is reasonable to assume that their presence in these mixtures attenuates toxicity. Further, as a worst-case approach is adopted in which 4,4’-MDI isomer is used for read-across to all substances of the MDI category, then use of RAAF Scenario 4 (variations in the properties observed among source substances) is justified over scenario 6.   Acute oral toxicity In the case of oral exposure, before the reactive NCO groups present on the substances of the MDI category have opportunity to react locally, or be absorbed, they polymerize in the acid environment of the stomach to form solid polyureas that are excreted via the feces without being absorbed. Consequently, if exposure were to occur by the oral route this would not lead to local or systemic effects. For MDI Mixed Isomers, the key study (Reliability 1) did not record mortality up to the limit dose of 2,000 mg/kg bw . A supporting study describing the acute oral toxicity of pMDI conducted similar to OECD 401 guideline (Reliability 2) also did not find any mortality up to the maximum dose tested, hence the LD50 is greater than 10,000 mg/kg bw . Other studies on MDI substances are consistent with this, albeit with lower reliability.  Four additional acute oral toxicity studies (Reliability 1) have been conducted on other representative substances of the category subgroups (i.e. ‘MDI, its condensation products and the reaction products with glycols’ and ‘MDI and its reaction products with glycols’). In all cases, there was no mortality up to the limit dose (5,000 mg/kg). The lack of mortality in the available acute oral toxicity across the available studies, alongside the lack of gross lesions in distal tissues (e.g. liver, kidney etc.) supports the lack of systemic bioavailability. The NCO groups present on MDI substances react with acids within the stomach leading to formation of an insoluble polymerized mass that is excreted in the feces without being absorbed (see Toxicokinetics).  Supporting evidence comes in the form of several accidental ingestion reports in dogs where ingestion of MDI based glues produced no intrinsic toxic effects other than the formation of a solid polyurea mass that may lead to gastric obstruction. When the mass was removed by surgery, rapid and complete recovery was achieved (Horstman et al., 2003; Ohngren, 2007).     Acute dermal toxicity In the case of dermal exposure, before the reactive NCO groups present on MDI substances have opportunity to be absorbed to any significant extent through the stratum corneum they react with proteins and moisture at the skin surface leading to the formation of an insoluble polymerized mass thereby limiting dermal absorption and systemic availability (Leibold 1999). Modified MDI substances, having a higher molecular weight than mMDI isomers and due to their higher molecular volume, increased octanol-water partition coefficient and decreased water solubility will in any event not be able to penetrate the stratum corneum (Bartels 2021). The available acute dermal toxicity studies indicate that all substances of the MDI category have low acute dermal toxicity. The key study describing the acute dermal toxicity of pMDI in rabbits did not find lethality up to the maximum dose tested, and the LD50 was greater than 9,400 mg/kg bw (Wazeter et al., 1964a). Other less reliable studies on pMDI or 4,4’-MDI are consistent with this.  Observed differences in LD50 values between pMDI and 4,4'-MDI/TPG are not considered to be significant or represent a trend since they are significantly higher than the limit for classification and are indicative of a lack of systemic exposure. The available data for the substances of the MDI category is consistent with the hypothesis that NCO groups present on MDI substances react with proteins and moisture at the skin surface leading to the formation of an insoluble polymerized mass resulting in limited dermal absorption and systemic availability. The available data and hypothesis is supported by the key dermal absorption study that shows that MDI substances have very low systemic bioavailability (<1 %) (Leibold et al., 1999). By comparison, modified MDI substances, with molecular weight greater than mMDI, will demonstrate even further reduced dermal absorption based upon physico-chemical properties (i.e. increased octanol-water partition coefficient, decreased water solubility, and increased molecular weight), and this has been confirmed with GastroPlus™ modeling (Bartels, 2021). Although a reliable, acute dermal in vivo toxicity data is only available on two category substances, it is considered sufficient for assessment of this endpoint for the category. Due to the low predicted dermal bioavailability of all category substances, and the lack of systemic toxicity demonstrated in the oral acute toxicity studies, additional testing is not justified as all substances of the MDI category would be predicted to have comparable or reduced acute dermal toxicity potential to tested substances.   Acute Inhalation Toxicity Following inhalation exposure the initiating event in hypothesised MoA for acute toxicity in the lung is the reaction of the MDI substance with GSH in the airway lining fluid (adduct formation). Subsequent development of toxic effects is driven by the rate of depletion of GSH. This depletion begins with the reduction in extracellular GSH, which leads to a reduction in intracellular GSH disturbing the redox balance in the cell. With increasing amounts of NCO exposure (e.g. via exposure concentration or bioaccessibility), the protective GSH system gradually becomes overwhelmed, and toxicity evolves along the path: (1) no cytotoxicity; (2) cytotoxic effects; (3) reduced cell viability; and (4) cell death. This is accompanied by increasing extravasation because of increased junction permeability and epithelial damage ultimately causing edema.    The rate of nucleophile depletion by MDI-based substances is driven by the availability of the NCO-group, which itself is a function of (1) the NCO value of the substance and (2) the molecular weight of its constituents (driving its reactive dissolution). Monomeric MDI isomers have been shown to become available at a similar rate in toxicokinetic studies (Wisnewski, 2018; Wisnewski et al., 2019a) which is consistent with the generally comparable LC50 values for all of the isomers. Conversely, higher molecular weight constituents have both a reduced NCO value and exhibit reduced water solubility, making them less accessible to react with GSH. Therefore, the substances with the highest available NCO value and bioaccessibility (mMDI and three-ring oligomers) are the most toxic, while those with increasing amounts constituents less able to react with GHS demonstrate reduced toxicity.   Tests also show that toxicity is limited to portal-of-entry effects. The absence of systemic toxicity is due to the extracellular reactions described above, combined with transcarbamoylation to proteins described in more detail in the Chapter (Toxicokinetics), constitute a detoxification mechanism. Acute toxicity is only observed when this protective mechanism becomes overwhelmed and is limited to the lung. This mode of action is supported with high confidence by reliable acute inhalation data available for multiple MDI isomers and modified MDI substances (described in more detail below). The toxicity of MDI substances will decrease with increasing average molecular weight as these substances will have constituents that are less bioaccessible and with a lower NCO value. For these substances, higher exposure concentration is required to induce toxic effects, which is consistent with the observed results from the available acute inhalation toxicity tests.  Testing proposal: While testing is available on 8 MDI category memeber (including all sub-groups) acute toxicity testing (OECD 403) will be performed on an additional 4 MDI substances.  This information will further support the category hypothesis as well as help to define substance selection and study design for repeat-dose bridging studies.    Available data: The ‘Monomeric MDI’ subgroup Reliable acute inhalation studies are available for all three isomers of mMDI (2,2’-; 2,4’-; and 4,4’-MDI) in accordance with OECD Guideline 403 in a series of studies by (Pauluhn, 2008d; Pauluhn, 2008e; Pauluhn, 2008f). All three substances consist of more than 98 % pure mMDI, corresponding to NCO value of 33%. In all cases, mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA. LC50s were comparable and ranged from 368 to 598 mg/m3 for males and from 559 to 686 mg/m3 for females. For all studies, exposure parameters met internationally recognized recommendations for MMAD and GSD and were similar for all three isomers. The ‘Oligomeric MDI’ subgroup Polymeric MDI (approximately 40 % mMDI; 33 % NCO value, with viscosity of approximately 200 mPas) was tested in an acute inhalation toxicity study according to OECD 403 (Pauluhn, 2008c). Mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA. An LC50 (95 % confidence interval) of 310.2 (266.4-361.3) mg/m3 was determined for pMDI.  Polymeric MDI was also tested following depletion of monomeric MDI resulting in a mixture of 1.2 % mMDI and 98.8 % of higher (> two-ring) oligomers according to OECD 403 (Pauluhn, 2011a). The combined LC50, for male and female rats, for ‘monomer-depleted pMDI’ was greater than 2,188 mg/m3. Average mean mass aerodynamic diameter (MMAD) and geometric standard deviation (GSD) was generally comparable to that of the pMDI containing mMDI (85-87 %). The ‘MDI and its condensation products’ subgroup The acute inhalation toxicity of MDI Mixed isomers/PIR (60 % mMDI and NCO value of 26 %) was tested in an acute inhalation toxicity study according to OECD 403 (Pauluhn, 2012). The combined LC50 for male and female rats was 1,088 mg/m3, mortality was linked to portal of entry effects of the respiratory system, including severe irritation and pulmonary edema. Mortality occurred up to two days post-exposure and was causally related to an acute pulmonary edema. The ‘MDI and its reaction products with glycols’ subgroup Two reliable acute inhalation studies are available for substances of the ‘MDI and its reaction products with glycols’ subgroup. The acute inhalation toxicity of 4,4'-MDI/1,3-BD/TPG/PG (60 % mMDI; 23 % NCO) was conducted according with OECD 403 (Kopf, 2016).  The LC50 was calculated to be 518 mg/m3, and mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA.  The acute inhalation study of 4,4'-MDI/DPG/HMWP (50 % mMDI; 25 % NCO) was tested according to OECD 403 (Hotchkiss and Weidemoyer, 2020). The LC50 is 1,110 mg/m3 for male rats and 1,250 mg/m3 for female rats. The four-hour LC50 is 1.15 mg/L for male and female rats combined. Similar to the other LC50 studies, mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA.   An acute inhalation study was performed in rats at only one concentration level of 2.24 mg/L/1h (Pauluhn 2003, 2004). This study was specifically designed to comply with NFPA 704, and also complied with the limit test of the OECD guideline 403 with deviations (only 1 hr exposure, concentration lower than limit test concentration) and is therefore reliable with restrictions. Exposure of 4,4’-MDI for 1 hr resulted in mortality shortly after exposure of one out of ten rats. Clinical signs were characterised by typical signs of respiratory tract irritation. Necropsy findings were unremarkable in surviving rats, whilst the rat that succumbed displayed signs of lung oedema which was considered to be the cause of death. The LC50 >2.24 mg/L/1h (analytical) in both males and females was determined.        Adequacy of the available data for risk assessment and classification purposes Using the strict GHS LC50 cut-off for classification, the LC50 values obtained for the mMDI would trigger a Category 2 (or Category 3) according to GHS CLP. However, classification for these substances according to ECHA CLP Guidance (2017) text allows for the application of scientific judgement. It must be considered that the LC50 cut-off of 500 mg/m3 (approximately 50 ppm for pMDI), is over 2,500-fold above the saturated vapor concentration for pMDI. This difference is even further exacerbated in the pre-polymer mixtures where the presence of the higher molecular weight fraction even further reduces the vapor pressure making exposure less likely.    Furthermore, the aerosols were generated using sophisticated techniques in the laboratory, whereby extremely small particles are generated in order to meet international guidelines for testing. This size and concentration of aerosol is not generated in the workplace even under foreseeable worst-case conditions (Ehnes et al., 2019). The particle size distribution of aerosols formed during actual spraying applications has virtually no overlap with that of the highly respirable aerosol generated in inhalation studies (see EC (2005)). Due to a very low vapor pressure (<0.01 Pa) MDI substances are not inherently toxic by inhalation since the saturated vapor concentration would be orders of magnitude below toxic concentration. It is only with modification and input (in terms of heat, cooling and size screening) that MDI substances become toxic after inhalation. In the EU risk assessment report (EU 2005) MDI is classified as  harmful by inhalation.   The acute inhalation data of pMDI and 4,4’-MDI data were considered by EU experts, and their conclusion that MDI be classified as “Harmful” and  reported in the 25th Adaptation to Technical Progress (ATP) to the Dangerous Substances Directive (67/548/EEC). This was endorsed in the 28th ATP and both MDI substances remain as “Harmful” in the 30th ATP (adopted by Member States on 16 February 2007 and published 15th September 2008). The original decision was upheld in the EU Risk Assessment of MDI (Directive 793/93/EEC, 3rd Priority List) published in 2005, noting that considering “the exposure assessment, it is reasonable to consider MDI as harmful only and to apply the risk management phrase ‘harmful by inhalation’. This classification was also endorsed by the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE, now SCHER) in giving their opinion on the Risk Assessment (EC, 2008). With the enforcement of the CLP regulation (Regulation (EC) No 1272/2008) in 2009, the Dangerous Substance/Preparation Directive (DSD) was repealed and harmonized classifications were formally transferred to the CLP regulation; MDI is classified with Acute Tox. 4 H332 (Annex VI Regulation (EC) No 1272/2008 (CLP regu lation). Given the mechanism of action of the MDI substances and the changes in physical chemical properties imparted by the modifications in the modified MDI substances, the entire category is consistent with this guidance and classification, and the classification should not be changed.   The classification as “Harmful”, is equivalent to GHS Category 4. For these reasons, the GHS proposal follows the EU Regulatory lead accepting that the animal data are inappropriate and classified pMDI as GHS acute toxicity category 4 (ISOPA 2007).    Conclusion    Assessment of the available acute toxicity data indicates that inhalation exposure to the aerosols of MDI results in toxicity confined predominantly to the respiratory tract. In terms of hazard characterization, MDI is harmful by inhalation according to EU (H332) and GHS (Cat. 4) classification. MDI is non-toxic after single oral and dermal exposure.     Justification for classification or non classification:    EU classification according to CLP: H332     GHS classification (GHS UN rev.2, 2007): Inhalation route (vapour): Acute Category 4.     Not toxic by the dermal or oral routes. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Results are consistent within the key study Bomhard (1990) (reliability1)and data from a supporting study (Wazeter et al. 1964) (reliability 2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b1ab441-bdc5-48dd-98e9-0525e10edbd2/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_8127b847-aa87-4837-a390-3383d641354f.html,,,,,, "4,4'-methylenediphenyl diisocyanate",101-68-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b1ab441-bdc5-48dd-98e9-0525e10edbd2/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_8127b847-aa87-4837-a390-3383d641354f.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4,4'-methylenediphenyl diisocyanate",101-68-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b1ab441-bdc5-48dd-98e9-0525e10edbd2/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_8127b847-aa87-4837-a390-3383d641354f.html,,inhalation,LC50,431 mg/m3,adverse effect observed, "α-methyl-1,3-benzodioxole-5-propionaldehyde",1205-17-0,Oral The key study was conducted under GLP conditions in accordance with the standardised guideline OECD 422. It was assigned a reliability score of 1 in accordance with the criteria detailed by Klimisch et al. (1997) and the quality of the database is therefore considered to be good. Dermal The key study was conducted equivalent to OECD guideline 411. It was assigned a reliability score of 1 in accordance with the criteria detailed by Klimisch et al. (1997) and the quality of the database is therefore considered to be good.  ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39fcc93b-a907-4ba7-a1cd-19ca5b6c1915/documents/3d1cf0e6-be6f-4b0f-923d-89509c3cc394_7bf7b1dd-3e31-488f-913b-2758edb313dd.html,,,,,, "α-methyl-1,3-benzodioxole-5-propionaldehyde",1205-17-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39fcc93b-a907-4ba7-a1cd-19ca5b6c1915/documents/3d1cf0e6-be6f-4b0f-923d-89509c3cc394_7bf7b1dd-3e31-488f-913b-2758edb313dd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "α-methyl-1,3-benzodioxole-5-propionaldehyde",1205-17-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39fcc93b-a907-4ba7-a1cd-19ca5b6c1915/documents/3d1cf0e6-be6f-4b0f-923d-89509c3cc394_7bf7b1dd-3e31-488f-913b-2758edb313dd.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,300 mg/kg bw/day,,rat "α-methyl-1,3-benzodioxole-5-propionaldehyde",1205-17-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39fcc93b-a907-4ba7-a1cd-19ca5b6c1915/documents/3d1cf0e6-be6f-4b0f-923d-89509c3cc394_7bf7b1dd-3e31-488f-913b-2758edb313dd.html,Repeated dose toxicity – local effects,dermal,NOAEL,2 mg/cm2,adverse effect observed,rat "α-methyl-1,3-benzodioxole-5-propionaldehyde",1205-17-0,Oral The key study was conducted under GLP conditions utilising a method which is similar or equivalent to the standardised guideline OECD 401. It was assigned a reliability score of 1 in accordance with the criteria detailed by Klimisch et al. (1997) and the quality of the database is therefore considered to be good. Dermal The key study was conducted under GLP conditions in accordance with a standardised guideline. It was assigned a reliability score of 2 in accordance with the criteria detailed by Klimisch (1997). The quality of the database is therefore considered to be good. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39fcc93b-a907-4ba7-a1cd-19ca5b6c1915/documents/5f25192f-93bd-4335-884c-f0c9f899bd4c_7bf7b1dd-3e31-488f-913b-2758edb313dd.html,,,,,, "α-methyl-1,3-benzodioxole-5-propionaldehyde",1205-17-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39fcc93b-a907-4ba7-a1cd-19ca5b6c1915/documents/5f25192f-93bd-4335-884c-f0c9f899bd4c_7bf7b1dd-3e31-488f-913b-2758edb313dd.html,,oral,LD50,"3,362 mg/kg bw",adverse effect observed, "α-methyl-1,3-benzodioxole-5-propionaldehyde",1205-17-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39fcc93b-a907-4ba7-a1cd-19ca5b6c1915/documents/5f25192f-93bd-4335-884c-f0c9f899bd4c_7bf7b1dd-3e31-488f-913b-2758edb313dd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-methylaminoethanol,109-83-1," BASF, 2010. Methylaminoethanol. Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test in Wistar Rats Oral Administration (Gavage). According to the GLP and OECD guideline 422. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bae0f2d5-e7e8-472d-9808-4e850ee32cfd/documents/IUC5-77073df6-b3d6-4330-87b1-175900e1ce70_2538abca-8a13-4092-a14d-7854d9484437.html,,,,,, 2-methylaminoethanol,109-83-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bae0f2d5-e7e8-472d-9808-4e850ee32cfd/documents/IUC5-77073df6-b3d6-4330-87b1-175900e1ce70_2538abca-8a13-4092-a14d-7854d9484437.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,50 mg/kg bw/day,,rat 2-methylaminoethanol,109-83-1," Acute toxicity oral: BASF AG, 1965. Industrial hygiene orientating investigation.Report No. XV/126. Comparable to OECD guideline 401. Acute toxicity dermal: BASF AG, 1981. Industrial hygiene orientating investigation.Report No. 79/561. Comparable to OECD guideline 402. Acute toxicity inhalation: BASF AG, 1965. Industrial hygiene orientating investigation.Report No. XV/126. Comparable to OECD guideline 403. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bae0f2d5-e7e8-472d-9808-4e850ee32cfd/documents/IUC5-237c0d92-2719-45a7-8dd4-dc72280cdc79_2538abca-8a13-4092-a14d-7854d9484437.html,,,,,, 2-methylaminoethanol,109-83-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bae0f2d5-e7e8-472d-9808-4e850ee32cfd/documents/IUC5-237c0d92-2719-45a7-8dd4-dc72280cdc79_2538abca-8a13-4092-a14d-7854d9484437.html,,oral,LD50,"1,880 mg/kg bw",adverse effect observed, 2-methylaminoethanol,109-83-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bae0f2d5-e7e8-472d-9808-4e850ee32cfd/documents/IUC5-237c0d92-2719-45a7-8dd4-dc72280cdc79_2538abca-8a13-4092-a14d-7854d9484437.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 5-methylheptan-3-one,541-85-5,"A NOAEL of 300 mg/kg bw/day was determined in a 90-day oral toxicity study with rats. The NOAEL was used for the derivation of a DNEL. At the highest dose, the study indicates effects of 5-methylheptan-3-one on body weight and food consumption, but does not lead to classification of the substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba75fad3-e835-41e7-95d9-9433d3186ef6/documents/IUC5-262559de-8101-4c11-b9ae-2e49b86352c6_6d3f6223-d8bc-425d-96d1-43b47ef952fb.html,,,,,, 5-methylheptan-3-one,541-85-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba75fad3-e835-41e7-95d9-9433d3186ef6/documents/IUC5-262559de-8101-4c11-b9ae-2e49b86352c6_6d3f6223-d8bc-425d-96d1-43b47ef952fb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 5-methylheptan-3-one,541-85-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Remark: the value is an LC100, the LC0 is 9400 mg/m3. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba75fad3-e835-41e7-95d9-9433d3186ef6/documents/IUC5-7d82b64e-9f26-4c57-804d-2c1498376349_6d3f6223-d8bc-425d-96d1-43b47ef952fb.html,,,,,, 5-methylheptan-3-one,541-85-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba75fad3-e835-41e7-95d9-9433d3186ef6/documents/IUC5-7d82b64e-9f26-4c57-804d-2c1498376349_6d3f6223-d8bc-425d-96d1-43b47ef952fb.html,,oral,LD50,"2,760 mg/kg bw",no adverse effect observed, 5-methylheptan-3-one,541-85-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba75fad3-e835-41e7-95d9-9433d3186ef6/documents/IUC5-7d82b64e-9f26-4c57-804d-2c1498376349_6d3f6223-d8bc-425d-96d1-43b47ef952fb.html,,dermal,LD50,"16,400 mg/kg bw",no adverse effect observed, 5-methylheptan-3-one,541-85-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba75fad3-e835-41e7-95d9-9433d3186ef6/documents/IUC5-7d82b64e-9f26-4c57-804d-2c1498376349_6d3f6223-d8bc-425d-96d1-43b47ef952fb.html,,inhalation,LC50,"18,900 mg/m3",adverse effect observed, octan-2-yl 16-methylheptadecanoate,209802-43-7,Studies conducted to recognised testing guidelines with GLP certification. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48094afa-a03a-48a0-a82e-328c14fbab92/documents/dc6c059d-29b1-4f2f-9773-0321c3617948_103157cb-7cc1-4984-b362-1d856b2427a7.html,,,,,, octan-2-yl 16-methylheptadecanoate,209802-43-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48094afa-a03a-48a0-a82e-328c14fbab92/documents/dc6c059d-29b1-4f2f-9773-0321c3617948_103157cb-7cc1-4984-b362-1d856b2427a7.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-methyl-2H-isothiazol-3-one,2682-20-4,"Repeated dose toxicity: oral -In a three month repeated dose toxicity (conducted according to OECD 408, US EPA OPPTS 870.3100 guidelines and in accordance with the Principles of Good Laboratory Practice), RH-573 Technical, when administered in the drinking water to rats for three months at doses of 0, 75, 250, or 1000 ppm active ingredient (a.i.), had a No Observed Adverse Effect Level (NOAEL) of 250 ppm (equivalent to 19.0 and 24.6 mg a.i./kg of body weight/day in males and females, respectively). Effects on body weight and feed consumption were noted at 1000 ppm (65.7 and 93.5 mg a.i./kg of body weight/day in males and females, respectively). There was no evidence of systemic toxicity at any dose level tested.In a thirteen week dietary toxicity study (conducted according to OECD 409, US EPA OPPTS 870.3150 guidelines and in accordance with the Principles of Good Laboratory Practice), 2 -methyl-4-Isothiazolin-3-one was administered daily via dietary admixture to dogs for 13 weeks at 0, 100/130, 400, and 1500 ppm, the no-observed effect level (NOEL) was determined to be 400 ppm (analytically verified, 9.9 mg/kg/day in males and 11.1 mg/kg/day in females) . Both sexes at 1500 ppm had decreased body weight and food consumptions. 2 -methyl-4 -Isothiazolin-3 -one produced no evidence of toxicity with respect to the pathology of any tissue or organ at any dose (up to and including 40.6 to 40.9 mg/kg/day). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c44f1b8-9e7d-4353-bc36-348ef4169deb/documents/d8104066-353b-44b6-81ea-b4167f686619_f2a397bd-62e3-4b9b-a639-06cff81fc1b3.html,,,,,, 2-methyl-2H-isothiazol-3-one,2682-20-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c44f1b8-9e7d-4353-bc36-348ef4169deb/documents/d8104066-353b-44b6-81ea-b4167f686619_f2a397bd-62e3-4b9b-a639-06cff81fc1b3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,19 mg/kg bw/day,,rat 2-methyl-2H-isothiazol-3-one,2682-20-4,"Acute toxicity: oral - An acute oral toxicity study was condcuted in accordance with Good Laboratory Practice (GLP) and as per US EPA OPPTS 870.1100 guideline. Groups of CD (BR) rats were administered orally via gavage 2-methylisothiazol-3(2H)-one at 150, 180, 225 and 300 mg a.i./kg. Under the conditions of the study, the Acute toxicity: inhalation - An acute inhalation toxicity study was condcuted in accordance with Good Laboratory Practice (GLP) and as per OECD 403 guideline. Groups of CD (BR) rats were exposed to an aerosol of 2-methylisothiazol-3(2H)-one via nose only at concentrations of 0.046, 0.012, 0.150, 1.07 and 2.09 mg/liter air. Under the conditions of the study, the four hour combined inhalative LC50 of 2-methyl-4-isothiazolin-3-one was calculated to be 0.11 mg RH-573 Technical per liter of air with 95% confidence limits of 0.07 to 0.25 mg/L. The LC50 for male rats was 0.13 mg/L (95% confidence limits = 0.06-0.53 mg/L) and for female rats the LC50 was 0.10 mg/L (confidence limits could not be calculated). There was no significant difference in the mortality response between male and female rats exposed to RH-573 Technical by nose-only inhalation. Acute toxicity: dermal - An acute dermal toxicity study was condcuted in accordance with Good Laboratory Practice (GLP) and as per US EPA OPPTS 870.1200 and OECD 402 guidelines. Groups of CD (BR) rats were exposed dermally to 2-methylisothiazol-3(2H)-one at 100, 200, 300 and 400 mg a.i./kg under occlusive conditions. Under the conditions of the study, the combined dermal LD50 of 2-methyl-4-isothiazolin-3-one was 242 mg/kg with 95% confidence limits of 192 to 294 mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c44f1b8-9e7d-4353-bc36-348ef4169deb/documents/82022179-f1fd-42cd-b700-7cb012c73fa6_f2a397bd-62e3-4b9b-a639-06cff81fc1b3.html,,,,,, 2-methyl-2H-isothiazol-3-one,2682-20-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c44f1b8-9e7d-4353-bc36-348ef4169deb/documents/82022179-f1fd-42cd-b700-7cb012c73fa6_f2a397bd-62e3-4b9b-a639-06cff81fc1b3.html,,oral,LD50,120 mg/kg bw,adverse effect observed, 2-methyl-2H-isothiazol-3-one,2682-20-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c44f1b8-9e7d-4353-bc36-348ef4169deb/documents/82022179-f1fd-42cd-b700-7cb012c73fa6_f2a397bd-62e3-4b9b-a639-06cff81fc1b3.html,,dermal,LD50,242 mg/kg bw,adverse effect observed, 2-methyl-2H-isothiazol-3-one,2682-20-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c44f1b8-9e7d-4353-bc36-348ef4169deb/documents/82022179-f1fd-42cd-b700-7cb012c73fa6_f2a397bd-62e3-4b9b-a639-06cff81fc1b3.html,,inhalation,LC50,0.34 mg/m3,adverse effect observed, 2-methyldecan-1-al,19009-56-4," NOAEL systemic = >- 1,000 mg/kg bw/d; OECD 422; Anon., 2010 (read across from n-undecanal) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df3baed4-0031-48eb-9cf9-a3c9d7c7dedf/documents/a9013f74-fba7-48fa-9d65-6351357adfba_ca261c1a-2a0b-4d6d-8334-f1fe85843f97.html,,,,,, 2-methyldecan-1-al,19009-56-4," LD50 = >2000 mg/kg bw; OECD 420; Anon, 2017 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df3baed4-0031-48eb-9cf9-a3c9d7c7dedf/documents/523ed255-3dad-4504-8f83-1a5e207cc552_ca261c1a-2a0b-4d6d-8334-f1fe85843f97.html,,,,,, Methyl 4-hydroxybenzoate,99-76-3," NOAEL (28 days, OECD 422, gavage, rat): 1000 mg/kg bw/d NOEL (90 days, OECD 408, gavage rat): 1000 mg/kg bw/d ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7df2b332-49d6-4add-b265-15529b5c691d/documents/103b194d-67dc-4681-9b08-14d5480b1eb3_04cb9e29-52b7-44ca-abb6-35de3ba3ad72.html,,,,,, Methyl 4-hydroxybenzoate,99-76-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7df2b332-49d6-4add-b265-15529b5c691d/documents/103b194d-67dc-4681-9b08-14d5480b1eb3_04cb9e29-52b7-44ca-abb6-35de3ba3ad72.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Methyl 4-hydroxybenzoate,99-76-3,"Oral:- male rats, LD50: 2100 mg/kg bw- male rats, LD50: > 5000 mg/kg bw- male mice, LD50: > 5600 mg/kg bw- mice, LD50: > 8000 mg/kg bw- female rats, LD50: > 15,000 mg/kg bw- guinea pigs, LD50: 3000 mg/kg bw- male dogs, LD50: > 2000 mg/kg bw- female rabbits, LD50: > 2000 mg/kg bw- dogs: LD50: 3000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7df2b332-49d6-4add-b265-15529b5c691d/documents/03d8e54d-47e3-4c8c-b16f-40d4c34d4a4d_04cb9e29-52b7-44ca-abb6-35de3ba3ad72.html,,,,,, Methyl 4-hydroxybenzoate,99-76-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7df2b332-49d6-4add-b265-15529b5c691d/documents/03d8e54d-47e3-4c8c-b16f-40d4c34d4a4d_04cb9e29-52b7-44ca-abb6-35de3ba3ad72.html,,oral,LD50,"> 2,100 mg/kg bw",no adverse effect observed, "2-methyl-1,3-propanediol",2163-42-0,"2-methyl-1,3-propanediol was tested in a sub-chronic 90 day oral toxicity test on rats ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/882ad15c-03ca-4f62-a3db-89602296fdee/documents/f9af9858-b8d6-4b00-b78a-7a8a2ca926fa_6ffa87b7-951c-429e-86e1-b3440b6765dc.html,,,,,, "2-methyl-1,3-propanediol",2163-42-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/882ad15c-03ca-4f62-a3db-89602296fdee/documents/f9af9858-b8d6-4b00-b78a-7a8a2ca926fa_6ffa87b7-951c-429e-86e1-b3440b6765dc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-methyl-1,3-propanediol",2163-42-0,"2-methyl-1,3-propanediol was tested by all 3 routes of exposure to rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/882ad15c-03ca-4f62-a3db-89602296fdee/documents/f86bc917-4c7e-4224-a567-e958dc30abbd_6ffa87b7-951c-429e-86e1-b3440b6765dc.html,,,,,, "2-methyl-1,3-propanediol",2163-42-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/882ad15c-03ca-4f62-a3db-89602296fdee/documents/f86bc917-4c7e-4224-a567-e958dc30abbd_6ffa87b7-951c-429e-86e1-b3440b6765dc.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-methyl-1,3-propanediol",2163-42-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/882ad15c-03ca-4f62-a3db-89602296fdee/documents/f86bc917-4c7e-4224-a567-e958dc30abbd_6ffa87b7-951c-429e-86e1-b3440b6765dc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-methyl-1,3-propanediol",2163-42-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/882ad15c-03ca-4f62-a3db-89602296fdee/documents/f86bc917-4c7e-4224-a567-e958dc30abbd_6ffa87b7-951c-429e-86e1-b3440b6765dc.html,,inhalation,LC50,"5,100 mg/m3",no adverse effect observed, 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one,71868-10-5, The key studies provided were conducted to recognised testing guidelines and with GLP certification. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b875f458-13b5-40fb-9c13-2d25be9c3d86/documents/d94095c9-0113-4d7e-97b3-86c2fb81264d_9f733081-97e0-49b1-bbd4-69caf009057d.html,,,,,, 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one,71868-10-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b875f458-13b5-40fb-9c13-2d25be9c3d86/documents/d94095c9-0113-4d7e-97b3-86c2fb81264d_9f733081-97e0-49b1-bbd4-69caf009057d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one,71868-10-5, The key studies provided were conducted to recognised testing guidelines and with GLP certification. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b875f458-13b5-40fb-9c13-2d25be9c3d86/documents/40267fba-d33a-44a8-b081-9aa1de3beab0_9f733081-97e0-49b1-bbd4-69caf009057d.html,,,,,, 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one,71868-10-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b875f458-13b5-40fb-9c13-2d25be9c3d86/documents/40267fba-d33a-44a8-b081-9aa1de3beab0_9f733081-97e0-49b1-bbd4-69caf009057d.html,,oral,LD50,"1,984 mg/kg bw",adverse effect observed, 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one,71868-10-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b875f458-13b5-40fb-9c13-2d25be9c3d86/documents/40267fba-d33a-44a8-b081-9aa1de3beab0_9f733081-97e0-49b1-bbd4-69caf009057d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Triethoxy(methyl)silane,2031-67-6,"Oral (subacute) repeated dose toxicity (OECD TG 422), rat: NOAEL = 150 mg/kg bw/day Oral (subchronic) repeated dose toxicity (OECD TG 408), rat: NOAEL = 200 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd264a9e-5e1c-4df2-bdde-8ea4bd7a362d/documents/c693cb20-41ab-4a83-bac8-cead05d05397_b3885994-1ab4-47e3-a4be-bacbeff46663.html,,,,,, Triethoxy(methyl)silane,2031-67-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd264a9e-5e1c-4df2-bdde-8ea4bd7a362d/documents/c693cb20-41ab-4a83-bac8-cead05d05397_b3885994-1ab4-47e3-a4be-bacbeff46663.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Triethoxy(methyl)silane,2031-67-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd264a9e-5e1c-4df2-bdde-8ea4bd7a362d/documents/c693cb20-41ab-4a83-bac8-cead05d05397_b3885994-1ab4-47e3-a4be-bacbeff46663.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Triethoxy(methyl)silane,2031-67-6,"Oral (OECD TG 401), rat: LD50 > 2007 mg/kg bw (limit test) Dermal (OCED TG 402), rat: LD50 > 2007 mg/kg bw (limit test) Inhalation (OCED TG 403), rat, 4 h exposure: LC50 > 13500 mg/m³ (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd264a9e-5e1c-4df2-bdde-8ea4bd7a362d/documents/9e7d31de-efd3-4251-942e-3ac4cb0e74b9_b3885994-1ab4-47e3-a4be-bacbeff46663.html,,,,,, Triethoxy(methyl)silane,2031-67-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd264a9e-5e1c-4df2-bdde-8ea4bd7a362d/documents/9e7d31de-efd3-4251-942e-3ac4cb0e74b9_b3885994-1ab4-47e3-a4be-bacbeff46663.html,,oral,LD50,"> 2,007 mg/kg bw",no adverse effect observed, Triethoxy(methyl)silane,2031-67-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd264a9e-5e1c-4df2-bdde-8ea4bd7a362d/documents/9e7d31de-efd3-4251-942e-3ac4cb0e74b9_b3885994-1ab4-47e3-a4be-bacbeff46663.html,,dermal,LD50,"> 2,007 mg/kg bw",no adverse effect observed, Triethoxy(methyl)silane,2031-67-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd264a9e-5e1c-4df2-bdde-8ea4bd7a362d/documents/9e7d31de-efd3-4251-942e-3ac4cb0e74b9_b3885994-1ab4-47e3-a4be-bacbeff46663.html,,inhalation,LC50,"> 13,500 mg/m3",adverse effect observed, Trimethoxy(methyl)silane,1185-55-3,"In the key Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test with trimethoxy(methyl)silane (MTMS, CAS 1185-55-3, EC 214-685-0), conducted according to OECD Test Guideline 422 and in compliance with GLP, the NOAEL for systemic effects was concluded to be 50 mg/kg bw/day based on organ weight and/or histomorphological changes in males (liver, thymus, thyroid, duodenum, jejunum, and red blood cell) and females (liver, thyroid, duodenum, jejunum, and adrenal gland) at dose levels at or above 250 mg/kg bw/day. In addition, a marked increase in prothrombin time was observed for males at 250 and 1000 mg/kg bw/day whereas females were unaffected, and exposure was associated with increased blood platelet concentration for males and females at 1000 mg/kg bw/day (Dow Corning Corporation, 2005, reliability 1).   In the key 90-day inhalation repeated dose toxicity study, conducted according to OECD Test Guideline 413 and in compliance with GLP, the NOAEL for systemic effects for trimethoxy(methyl)silane vapor administered six hours per day, five days per week via whole-body inhalation exposure to male and female Sprague-Dawley rats, was 100 ppm (equivalent to 0.56 mg/L) based on the increased incidence of grossly observed urinary bladder calculi along with the kidney dilation at the 400 ppm exposure level (Dow Corning Corporation, 2008, reliability 1). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/40ee8613-502d-4211-bb1a-90651249fa49/documents/6ab77c60-60d3-48c3-b1f6-02382e810903_9561f8d5-d946-4c23-9640-9274b0716d88.html,,,,,, Trimethoxy(methyl)silane,1185-55-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/40ee8613-502d-4211-bb1a-90651249fa49/documents/6ab77c60-60d3-48c3-b1f6-02382e810903_9561f8d5-d946-4c23-9640-9274b0716d88.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Trimethoxy(methyl)silane,1185-55-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/40ee8613-502d-4211-bb1a-90651249fa49/documents/6ab77c60-60d3-48c3-b1f6-02382e810903_9561f8d5-d946-4c23-9640-9274b0716d88.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,560 mg/m3,,rat Trimethoxy(methyl)silane,1185-55-3,"The key study for acute oral toxicity in rat reports an LD50 value for trimethoxy(methyl)silane (MTMS, CAS 1185-55-3, EC 214-685-0) of 11685 mg/kg bw in rat (Mellon Institute, 1963, reliability 2). Clinical signs of toxicity were sluggishness and unsteady gait post-dosing. At necropsy, gross examination revealed congested lungs, mottled livers with prominent acini and some haemorrhage and congestion of the gastrointestinal tract. The study did not follow specific test guidelines but was well documented and meets generally accepted scientific principles. It was not conducted in compliance with GLP.   In the key acute inhalation study conducted according to OECD Test Guideline 403 study and in compliance with GLP, an LC50 value for trimethoxy(methyl)silane of >42.1 mg/L was reported (Dow Corning Corporation, 2006, reliability 1). Clinical signs were urine staining, discoloured urine, fecal staining, head and muzzle soiling. Necropsy findings included urinary bladder calculi and kidney foci in both sexes, an enlarged kidney in one male, and abscessed prostate glands in two males. The study was conducted according to the appropriate OECD test guideline and in compliance with GLP.   The key acute dermal LD50 for trimethoxy(methyl)silane is >9500 mg/kg (Mellon Institute, 1963, reliability 2). There were no clinical signs of toxicity and no abnormalities were detected at necropsy. The study was conducted according to a protocol that was similar to OECD Test Guideline 402 and was well documented and generally meets accepted scientific principles. Deviations included the use of occlusive dressings. The study was not conducted in compliance with GLP. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40ee8613-502d-4211-bb1a-90651249fa49/documents/d9f5f0eb-a28e-4ee0-a00a-fc85ce1260c3_9561f8d5-d946-4c23-9640-9274b0716d88.html,,,,,, Trimethoxy(methyl)silane,1185-55-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40ee8613-502d-4211-bb1a-90651249fa49/documents/d9f5f0eb-a28e-4ee0-a00a-fc85ce1260c3_9561f8d5-d946-4c23-9640-9274b0716d88.html,,oral,LD50,"11,685 mg/kg bw",no adverse effect observed, Trimethoxy(methyl)silane,1185-55-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40ee8613-502d-4211-bb1a-90651249fa49/documents/d9f5f0eb-a28e-4ee0-a00a-fc85ce1260c3_9561f8d5-d946-4c23-9640-9274b0716d88.html,,dermal,LD50,"> 9,500 mg/kg bw",no adverse effect observed, Trimethoxy(methyl)silane,1185-55-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40ee8613-502d-4211-bb1a-90651249fa49/documents/d9f5f0eb-a28e-4ee0-a00a-fc85ce1260c3_9561f8d5-d946-4c23-9640-9274b0716d88.html,,inhalation,LC50,> 42.1 mg/m3,no adverse effect observed, 2-methylundecanal,110-41-8,"Dietary administration of Aldehyde C12 MNA Pure for at least 90 days to male and female rats resulted in a No Observed Adverse Effect Level (NOAEL) of 15000 ppm, corresponding to dose levels of 1046 mg/kg (males) and 1211 mg/kg (females). Aldehyde C12 MNA was assessed for repeated dose oral toxicity according to OECD 408. The No Observed Adverse Effect Level (NOAEL) for the rat was considered to be 15000 ppm,corresponding to dose levels of 1046 mg/kg (males) and 1211 mg/kg (females). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d35b323-ca42-4d9b-954d-927a39fdfd8c/documents/IUC5-9309515c-e94d-4742-98b7-47d25e265710_3ea88e03-f39d-4b53-8893-f2caf78c3618.html,,,,,, 2-methylundecanal,110-41-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d35b323-ca42-4d9b-954d-927a39fdfd8c/documents/IUC5-9309515c-e94d-4742-98b7-47d25e265710_3ea88e03-f39d-4b53-8893-f2caf78c3618.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,046 mg/kg bw/day",,rat 2-methylundecanal,110-41-8,The acute oral toxicity of the test substance to rats was studied in a standard acute method. The LD₅₀ was determined to be >5000 mg/kg bw.The test material was assessed for acute dermal toxicity using rabbits. The test material was not acutely toxic to rabbits via the dermal route at a concentration of 10 mL/kg bw.No study is available for acute inhalation toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d35b323-ca42-4d9b-954d-927a39fdfd8c/documents/IUC5-1c76e094-fb88-42f3-aab9-78e131e64e1b_3ea88e03-f39d-4b53-8893-f2caf78c3618.html,,,,,, 2-methylundecanal,110-41-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d35b323-ca42-4d9b-954d-927a39fdfd8c/documents/IUC5-1c76e094-fb88-42f3-aab9-78e131e64e1b_3ea88e03-f39d-4b53-8893-f2caf78c3618.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-methylundecanal,110-41-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d35b323-ca42-4d9b-954d-927a39fdfd8c/documents/IUC5-1c76e094-fb88-42f3-aab9-78e131e64e1b_3ea88e03-f39d-4b53-8893-f2caf78c3618.html,,dermal,LD50,"8,280 mg/kg bw",no adverse effect observed, 4-methylpentan-2-one,108-10-1,"The NOAEC for methyl isobutyl ketone (MIBK) from a GLP 2-year whole-body inhalation study in F344N rats (equivalent to OECD Test Guideline 451) was determined to be 450 ppm. A similar NOAEC of 450 ppm was determined for B6C3F1 mice in a concurrent 2-year study. Ninety-day inhalation studies in Fischer 344 rats and B6C3F1 mice also were conducted and a NOAEC of 1002 ppm was established for both species. In an oral (gavage) subchronic toxicity study in Sprague-Dawley rats, the no-observed adverse effect level (NOAEL) was established at 250 mg/kg body weight/day. No dermal repeat-dose toxicity studies have been conducted. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03ddb471-89eb-454f-b4a1-a41fa7914745/documents/364e657f-bda7-4d48-b8ac-09575f1cc1e5_12c1f98a-bfdf-4182-9677-18eb0cbe7d79.html,,,,,, 4-methylpentan-2-one,108-10-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03ddb471-89eb-454f-b4a1-a41fa7914745/documents/364e657f-bda7-4d48-b8ac-09575f1cc1e5_12c1f98a-bfdf-4182-9677-18eb0cbe7d79.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 4-methylpentan-2-one,108-10-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03ddb471-89eb-454f-b4a1-a41fa7914745/documents/364e657f-bda7-4d48-b8ac-09575f1cc1e5_12c1f98a-bfdf-4182-9677-18eb0cbe7d79.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,843 mg/m3",,rat 4-methylpentan-2-one,108-10-1,"MIBK shows a low degree of toxicity by oral, dermal or inhalation routes in rats. The acute LD50 by oral route was 2080 mg/kg bw, the acute LD0 by dermal route was greater than 2000 mg/kg bw and the acute 4-hour inhalation LC50 was betweem 2000 and 4000 ppm (8200 and 16400 mg/m3, respectively). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03ddb471-89eb-454f-b4a1-a41fa7914745/documents/b93ceed4-d544-4800-8542-07ca4e6a3b34_12c1f98a-bfdf-4182-9677-18eb0cbe7d79.html,,,,,, 4-methylpentan-2-one,108-10-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03ddb471-89eb-454f-b4a1-a41fa7914745/documents/b93ceed4-d544-4800-8542-07ca4e6a3b34_12c1f98a-bfdf-4182-9677-18eb0cbe7d79.html,,oral,LD50,"2,080 mg/kg bw",adverse effect observed, 4-methylpentan-2-one,108-10-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03ddb471-89eb-454f-b4a1-a41fa7914745/documents/b93ceed4-d544-4800-8542-07ca4e6a3b34_12c1f98a-bfdf-4182-9677-18eb0cbe7d79.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 4-methylpentan-2-one,108-10-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03ddb471-89eb-454f-b4a1-a41fa7914745/documents/b93ceed4-d544-4800-8542-07ca4e6a3b34_12c1f98a-bfdf-4182-9677-18eb0cbe7d79.html,,inhalation,discriminating conc.,"8,200 mg/m3",adverse effect observed, Ligroine,8032-32-4,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9aaa0802-6a5d-4f5e-bc09-fd7763d34d56/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_701749ec-22a3-420b-8d24-aa3eacdbaa2a.html,,,,,, Ligroine,8032-32-4,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9aaa0802-6a5d-4f5e-bc09-fd7763d34d56/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_701749ec-22a3-420b-8d24-aa3eacdbaa2a.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse Ligroine,8032-32-4,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9aaa0802-6a5d-4f5e-bc09-fd7763d34d56/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_701749ec-22a3-420b-8d24-aa3eacdbaa2a.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat Ligroine,8032-32-4,"The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401)Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions)Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9aaa0802-6a5d-4f5e-bc09-fd7763d34d56/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_701749ec-22a3-420b-8d24-aa3eacdbaa2a.html,,,,,, Ligroine,8032-32-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9aaa0802-6a5d-4f5e-bc09-fd7763d34d56/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_701749ec-22a3-420b-8d24-aa3eacdbaa2a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Ligroine,8032-32-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9aaa0802-6a5d-4f5e-bc09-fd7763d34d56/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_701749ec-22a3-420b-8d24-aa3eacdbaa2a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ligroine,8032-32-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9aaa0802-6a5d-4f5e-bc09-fd7763d34d56/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_701749ec-22a3-420b-8d24-aa3eacdbaa2a.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Alcohols, C12-14 (even numbered), ethoxylated (<=2.5 moles EO), sulfated, monoisopropanolamine salt",1187742-72-8," The assessment is based on the data currently available. New studies, based on the category review and the final decisions issued for some of the category substances, which are also relevant for this assessment, are currently being conducted. The hazard assessment with respect to repeated dose toxicity will be updated once all ongoing studies have been finalised. For the whole category of alcohol ethoxysulfates (AES) a oral NOAEL of 300 mg/kg bw/d was established. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16666195-7700-44df-90e2-662a33348fc3/documents/IUC5-c9db8c49-cc7c-43ac-8fa2-ffe36b1fd6cf_4031ca95-b7bc-43b6-ae2d-d1712c229899.html,,,,,, "Alcohols, C12-14 (even numbered), ethoxylated (<=2.5 moles EO), sulfated, monoisopropanolamine salt",1187742-72-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16666195-7700-44df-90e2-662a33348fc3/documents/IUC5-c9db8c49-cc7c-43ac-8fa2-ffe36b1fd6cf_4031ca95-b7bc-43b6-ae2d-d1712c229899.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Alcohols, C12-14 (even numbered), ethoxylated (<=2.5 moles EO), sulfated, monoisopropanolamine salt",1187742-72-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16666195-7700-44df-90e2-662a33348fc3/documents/IUC5-c9db8c49-cc7c-43ac-8fa2-ffe36b1fd6cf_4031ca95-b7bc-43b6-ae2d-d1712c229899.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,195 mg/kg bw/day,,mouse "Alcohols, C12-14 (even numbered), ethoxylated (<=2.5 moles EO), sulfated, monoisopropanolamine salt",1187742-72-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16666195-7700-44df-90e2-662a33348fc3/documents/IUC5-c9db8c49-cc7c-43ac-8fa2-ffe36b1fd6cf_4031ca95-b7bc-43b6-ae2d-d1712c229899.html,Repeated dose toxicity – local effects,dermal,NOAEL,397 ,adverse effect observed, "Alcohols, C12-14 (even numbered), ethoxylated (<=2.5 moles EO), sulfated, monoisopropanolamine salt",1187742-72-8,"Oral LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute oral toxicity in the Alkyl Ether Sulfates (AES) category in a Weight-of-Evidence approach.   Inhalation No information required according to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, as data on acute oral and acute dermal toxicity are provided.   Dermal LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute dermal toxicity in the AES category in a Weight-of-Evidence approach. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate and reliable (Klimisch score 1 and 2) studies from various source substances in the Alkyl Ether Sulfates (AES) category with similar structures and intrinsic properties. Read-across is justified based on common toxicokinetic behaviour and consistent trends in environmental fate, ecotoxicological and toxicological properties of the category member substances. The database of the AES category is thus sufficient to fulfil the standard information requirements set out in Annex VII, Section 8.5, in accordance with Annex XI, Section 1.5, of the REACH Regulation (EC) No. 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate and reliable (Klimisch score 1 and 2) studies from various source substances in the Alkyl Ether Sulfates (AES) category with similar structures and intrinsic properties. Read-across is justified based on common toxicokinetic behaviour and consistent trends in environmental fate, ecotoxicological and toxicological properties of the category member substances. The database of the AES category is thus sufficient to fulfil the standard information requirements set out in Annex VIII, Section 8.5, in accordance with Annex XI, Section 1.5, of the REACH Regulation (EC) No. 1907/2006. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16666195-7700-44df-90e2-662a33348fc3/documents/IUC5-8ad74fd1-780d-4ece-8326-09232aff4535_4031ca95-b7bc-43b6-ae2d-d1712c229899.html,,,,,, "Alcohols, C12-14 (even numbered), ethoxylated (<=2.5 moles EO), sulfated, monoisopropanolamine salt",1187742-72-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16666195-7700-44df-90e2-662a33348fc3/documents/IUC5-8ad74fd1-780d-4ece-8326-09232aff4535_4031ca95-b7bc-43b6-ae2d-d1712c229899.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alcohols, C12-14 (even numbered), ethoxylated (<=2.5 moles EO), sulfated, monoisopropanolamine salt",1187742-72-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16666195-7700-44df-90e2-662a33348fc3/documents/IUC5-8ad74fd1-780d-4ece-8326-09232aff4535_4031ca95-b7bc-43b6-ae2d-d1712c229899.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Molybdic acid,7782-91-4," NOAEL for systemic toxicity, oral, from a sub-chronic study in rats: 17 mg Mo/kg bw/day. NOAEC for systemic toxicity, inhalation, from a sub-chronic study in rats and mice: 66.7 mg Mo/m³. Important: both values based on element Mo. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09763ffd-f076-4b3e-891c-796546999df8/documents/93994fac-3e6d-4769-b371-39a928767240_46568449-eaf8-4190-b779-590353d44df4.html,,,,,, Molybdic acid,7782-91-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09763ffd-f076-4b3e-891c-796546999df8/documents/93994fac-3e6d-4769-b371-39a928767240_46568449-eaf8-4190-b779-590353d44df4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat Molybdic acid,7782-91-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09763ffd-f076-4b3e-891c-796546999df8/documents/93994fac-3e6d-4769-b371-39a928767240_46568449-eaf8-4190-b779-590353d44df4.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,66.7 mg/m3,,"other:rat, mice" Sodium dihydrogen citrate,18996-35-5,"A fairly limited reliable report of a non-standard oral feeding study using sodium dihydrogen citrate in the rat, conducted without GLP compliance, identified 10-day NOAEL and LOAEL values in the rat of 8 and 16 g/kg bw/day, respectively. (Bachtold 1978; rel 2) In addition a fairly limited reliable report of a non-standard study using sodium dihydrogen citrate conducted without GLP compliance, identified 10-day NOAEL and LOAEL values in the mouse of 4 and 8 g/kg bw/day, respectively. Data from a 150 day oral feeding study where rats were given up to 7.7% as sodium dihydrogen citrate in their diet reported no abnormalities. (Packman et al 1963; rel 4) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f1ee8a3-b33f-4d48-9b44-9d16467daa69/documents/IUC5-fccfd3f0-43ad-47cb-b8a1-6405e382e2ae_23d6fea4-3451-456d-99a2-0d075f458a1b.html,,,,,, Sodium dihydrogen citrate,18996-35-5,"The key study for acute oral toxicity was read across from citric acid, which reports an LD50 value of 5400mg/kg (Roche 1981; rel 2). [PLACEHOLDER FOR DERMAL TOX READ ACROSS]. Data for the acute toxicity inhalation endpoint was waived, since reliable data was available for the acute oral and dermal endpoints. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f1ee8a3-b33f-4d48-9b44-9d16467daa69/documents/IUC5-8ed424c8-a58d-462c-9e6f-7dd9e01a106d_23d6fea4-3451-456d-99a2-0d075f458a1b.html,,,,,, Sodium dihydrogen citrate,18996-35-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f1ee8a3-b33f-4d48-9b44-9d16467daa69/documents/IUC5-8ed424c8-a58d-462c-9e6f-7dd9e01a106d_23d6fea4-3451-456d-99a2-0d075f458a1b.html,,oral,LD50,"5,400 mg/kg bw",, Morpholine,110-91-8,"Oral (sub-chronic repeated dose toxicity): NOAEL = 200 mg/kg bw/d, according OECD 443, GLP Inhalation (chronic repeated dose toxicity): NOAEC (systemic) = 543 mg/m³ air, NOAEC (local) = 36 mg/m³ similar OECD 453, GLP Dermal (short-term repeated dose toxicity): systemic NOAEL could not be determined due to the pronounced local effects, no guideline, no GLP ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b261451-1ca1-4dd0-a11c-82e4ea355390/documents/IUC5-51aa4835-e86c-412f-b67e-50b16dcc20bf_a375c790-466f-4362-b38c-35f0fa0f0053.html,,,,,, Morpholine,110-91-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b261451-1ca1-4dd0-a11c-82e4ea355390/documents/IUC5-51aa4835-e86c-412f-b67e-50b16dcc20bf_a375c790-466f-4362-b38c-35f0fa0f0053.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Morpholine,110-91-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b261451-1ca1-4dd0-a11c-82e4ea355390/documents/IUC5-51aa4835-e86c-412f-b67e-50b16dcc20bf_a375c790-466f-4362-b38c-35f0fa0f0053.html,Chronic toxicity – systemic effects,inhalation,NOAEC,543 mg/m3,,rat Morpholine,110-91-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b261451-1ca1-4dd0-a11c-82e4ea355390/documents/IUC5-51aa4835-e86c-412f-b67e-50b16dcc20bf_a375c790-466f-4362-b38c-35f0fa0f0053.html,Repeated dose toxicity – local effects,inhalation,NOAEC,36 mg/m3,adverse effect observed,rat Morpholine,110-91-8,"oral: LD50 = ca. 1900 mg/kg bw, similar to OECD TG 401, no GLP, rat, 1967, K2 inhalation: WoE approach, LC50 = 8000 mg/m³, similar to OECD TG 403, no GLP, rat, K2 dermal: LD50 = 500 mg/kg bw, similar to OECD TG 402, no GLP, rabbit, K2 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b261451-1ca1-4dd0-a11c-82e4ea355390/documents/IUC5-0da14f54-0d40-45ba-b369-78d8efc37e3f_a375c790-466f-4362-b38c-35f0fa0f0053.html,,,,,, Morpholine,110-91-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b261451-1ca1-4dd0-a11c-82e4ea355390/documents/IUC5-0da14f54-0d40-45ba-b369-78d8efc37e3f_a375c790-466f-4362-b38c-35f0fa0f0053.html,,oral,LD50,"1,900 mg/kg bw",adverse effect observed, Morpholine,110-91-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b261451-1ca1-4dd0-a11c-82e4ea355390/documents/IUC5-0da14f54-0d40-45ba-b369-78d8efc37e3f_a375c790-466f-4362-b38c-35f0fa0f0053.html,,dermal,LD50,500 mg/kg bw,adverse effect observed, Morpholine,110-91-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b261451-1ca1-4dd0-a11c-82e4ea355390/documents/IUC5-0da14f54-0d40-45ba-b369-78d8efc37e3f_a375c790-466f-4362-b38c-35f0fa0f0053.html,,inhalation,LC50,"8,000 mg/m3",adverse effect observed, 4-morpholinopropanesulphonic acid,1132-61-2," A study with the structurally similar substance CAS 1266615-59-1 is available. In this toxicity study after oral application to rats, no treatment-related toxicological effects were observed and the NOAEL was 1000 mg/kg bw/day, i.e. the highest dose tested (reference 7.5.1 -1). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad4ebef2-619a-414e-a0a0-978b9ee99640/documents/fd22234a-8ca0-4f17-8b92-d3540ae68252_0451dd1e-e885-4cd7-acd5-78bd1210af83.html,,,,,, 4-morpholinopropanesulphonic acid,1132-61-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad4ebef2-619a-414e-a0a0-978b9ee99640/documents/fd22234a-8ca0-4f17-8b92-d3540ae68252_0451dd1e-e885-4cd7-acd5-78bd1210af83.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-morpholinopropanesulphonic acid,1132-61-2,"In a GLP-study according to OECD TG 423 (acute class method) with rats, the LD50 of the substance was determined as > 2000 mg/kg bw (reference 7.2.1 -1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study was performed according to OECD TG 423 (GLP). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad4ebef2-619a-414e-a0a0-978b9ee99640/documents/e65cd205-8323-4b89-be66-465d1e5ac890_0451dd1e-e885-4cd7-acd5-78bd1210af83.html,,,,,, 4-morpholinopropanesulphonic acid,1132-61-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad4ebef2-619a-414e-a0a0-978b9ee99640/documents/e65cd205-8323-4b89-be66-465d1e5ac890_0451dd1e-e885-4cd7-acd5-78bd1210af83.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4'-tert-butyl-2',6'-dimethyl-3',5'-dinitroacetophenone",81-14-1," Repeated dose toxicity (dermal, subchronic): NOAEL = 75 mg/kg bw/day (Equivalent or similar to OECD 411) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8fdc3bb-c3de-4de5-9836-86c61b3b7e8f/documents/d866571a-c24d-4641-a90e-84004671157a_45834591-aad4-4e86-825c-b040f4d82625.html,,,,,, "4'-tert-butyl-2',6'-dimethyl-3',5'-dinitroacetophenone",81-14-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8fdc3bb-c3de-4de5-9836-86c61b3b7e8f/documents/d866571a-c24d-4641-a90e-84004671157a_45834591-aad4-4e86-825c-b040f4d82625.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,75 mg/kg bw/day,,rat "4'-tert-butyl-2',6'-dimethyl-3',5'-dinitroacetophenone",81-14-1, Acute oral toxicity: LD50 (male/female): >5000 mg/kg bw (Equivalent or similar to 401) Acute inhalation toxicity: LC50 (male/female): > 2.99 ± 0.120 mg/L (OECD 403/GLP) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8fdc3bb-c3de-4de5-9836-86c61b3b7e8f/documents/0ed7577c-c6f9-40b3-85b8-f24d0783145c_45834591-aad4-4e86-825c-b040f4d82625.html,,,,,, "4'-tert-butyl-2',6'-dimethyl-3',5'-dinitroacetophenone",81-14-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8fdc3bb-c3de-4de5-9836-86c61b3b7e8f/documents/0ed7577c-c6f9-40b3-85b8-f24d0783145c_45834591-aad4-4e86-825c-b040f4d82625.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "4'-tert-butyl-2',6'-dimethyl-3',5'-dinitroacetophenone",81-14-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8fdc3bb-c3de-4de5-9836-86c61b3b7e8f/documents/0ed7577c-c6f9-40b3-85b8-f24d0783145c_45834591-aad4-4e86-825c-b040f4d82625.html,,inhalation,LC50,2.99 mg/m3,no adverse effect observed, 11-oxahexadecan-16-olide,3391-83-1," The experimental in vivo acute oral toxicity study the LD50 was 16.8 ml/kg (11.9 - 23.8 ml/kg). The trend analysis QSAR prediction (OECD QSAR Toolbox) where the domain is made up of other ""Ether, Cyclic"" and Lactone rings gives a LD50 value of 5420 mg/kg which is slightly more toxic than the in vivo data. The read-Across QSAR prediction (OECD QSAR Toolbox) where the domain is also made up mainly of other ""Ether, Cyclic"" and Lactone rings gives a LD50 value of 6280 mg/kg which is again slightly more toxic than the in vivo data. However, the experimental data and the trend analysis and read-across predictions are all above the current criteria for oral acute classification. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/836a40ec-3a50-49e2-b260-24a80d2430bb/documents/346daa8e-f1c5-4bba-aa47-807730cd8b18_fb77cbb9-9955-4010-a86d-06f612772179.html,,,,,, 11-oxahexadecan-16-olide,3391-83-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/836a40ec-3a50-49e2-b260-24a80d2430bb/documents/346daa8e-f1c5-4bba-aa47-807730cd8b18_fb77cbb9-9955-4010-a86d-06f612772179.html,,oral,LD50,"11,900 mg/kg bw",no adverse effect observed, Myrcenyl acetate,1118-39-4,Acute oral toxicity: similar to OECD TG 401: 6300 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f74d178-4810-4cd7-9bb7-b7849958fd6f/documents/IUC5-1c23a759-83c7-45e5-82bb-9f524302821c_e6cfdb92-265c-4bf0-8f14-11c52f0a511f.html,,,,,, Miristalkonium chloride,139-08-2," For the oral route, based on the effects observed in the 90-day read across study, the NOEL for the test substance, C14 ADBAC, can be considered to be at 500 ppm in the diet (i.e., equivalent to 31 mg/kg bw/day (or 25 mg a.i./kg bw/d) for males and 38 mg/kg bw/d (i.e. 30 mg a.i./kg bw/d) for females). With regard to the dermal route, a 20-day repeated dose dermal study available with C14 ADBAC in rabbits, revealed only local effects (severe erythema, oedema, thickening of the skin and eschar formation across the back) at the site of application without presence of any systemic effects. The NOAEL for systemic effects was therefore established at 3.2 mg/kg bw/day and the LOAEL for local effects at 0.8 mg/kg bw/day. However, due to some deficiencies in the study (e.g., reduced number of test animals per group), the 90-day oral study with the read across substance, C12-16 ADBAC, has been used for hazard assessment of systemic effects following repeated dosing via dermal route. However, in line with the Biocides dossier on the read across substance, it can be concluded that there were no primary systemic effects observed in the repeated dose studies and all observed effects could be attributed to local gastrointestinal irritaton/corrosion and consequent reduced food intake. Therefore, the derivation of a DNEL for systemic effects via oral or dermal route has been deemed inappropriate. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a6feee2-c874-4a3b-aef8-4b84a7c31f28/documents/f753bac1-3e20-4e4e-a637-93873cdf5210_db13175f-46aa-4613-9b1e-4af6fd7fce26.html,,,,,, Miristalkonium chloride,139-08-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a6feee2-c874-4a3b-aef8-4b84a7c31f28/documents/f753bac1-3e20-4e4e-a637-93873cdf5210_db13175f-46aa-4613-9b1e-4af6fd7fce26.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Miristalkonium chloride,139-08-2," Based on the results of the read across studies, the oral and dermal LD50 values of the test substance, C14 ADBAC, can be considered to be 344 mg/kg bw and 2730 mg/kg bw respectively. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a6feee2-c874-4a3b-aef8-4b84a7c31f28/documents/37d25db4-0eee-4736-ac6e-d8700589a129_db13175f-46aa-4613-9b1e-4af6fd7fce26.html,,,,,, Miristalkonium chloride,139-08-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a6feee2-c874-4a3b-aef8-4b84a7c31f28/documents/37d25db4-0eee-4736-ac6e-d8700589a129_db13175f-46aa-4613-9b1e-4af6fd7fce26.html,,oral,LD50,344 mg/kg bw,adverse effect observed, Miristalkonium chloride,139-08-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a6feee2-c874-4a3b-aef8-4b84a7c31f28/documents/37d25db4-0eee-4736-ac6e-d8700589a129_db13175f-46aa-4613-9b1e-4af6fd7fce26.html,,dermal,LD50,"2,730 mg/kg bw",adverse effect observed, "N,N-dimethyltetradecylamine N-oxide",3332-27-2,"No studies investigating repeated dose oral toxicity have been performed using C14 AO. Data are read across from two other members of the amine oxide category, C12-14 and C12-18 AO, both of which contain a significant proportion of C14 AO itself, the remainder comprising analogues with very similar chain lengths.The key study for the oral route is a 90-day repeated dose oral toxicity study in rats comparable to OECD TG 408 [Hazelton Laboratories (1974)] performed with C12-14 AO. The NOAEL was 0.1% (in the diet) or 1000 mg AO/kg diet. Using a food consumption factor of 0.088 kg food/kg bw/day for rats of this strain and age, this translates into a delivered dose of 88 mg AO/kg bw/day. This value represents the highest NOAEL below the lowest LOAEL and was selected for use in the risk assessment to characterize the risk of long term systemic toxicity via the oral and (by route to route extrapolation) dermal and inhalation routes.With regard to dermal toxicity, repeated dermal treatment of mice (6 hours/day/5 days/week) for 90 days with C12-14 AO at dosage levels of 0.27 % AO and 1.33 % AO revealed local signs of irritation but no effects attributable to direct systemic toxicity. A NOAEL regarding systemic effects was therefore not established. Under the conditions of the study the LOEL for local dermal toxicity (irritation) in mice was determined to be 0.27 % AO. Based on an applied dose of 0.27 mg and a patch area of 6 cm2, this is equivalent to 0.045 mg/cm2. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0642c8df-605a-4203-b161-1578619f9f7f/documents/IUC5-15eba0ca-c34b-4fba-ad97-847c831fd537_f2fbd6f9-ef72-4111-9db5-27079f1e8fff.html,,,,,, "N,N-dimethyltetradecylamine N-oxide",3332-27-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0642c8df-605a-4203-b161-1578619f9f7f/documents/IUC5-15eba0ca-c34b-4fba-ad97-847c831fd537_f2fbd6f9-ef72-4111-9db5-27079f1e8fff.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,88 mg/kg bw/day,,rat "N,N-dimethyltetradecylamine N-oxide",3332-27-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0642c8df-605a-4203-b161-1578619f9f7f/documents/IUC5-15eba0ca-c34b-4fba-ad97-847c831fd537_f2fbd6f9-ef72-4111-9db5-27079f1e8fff.html,Repeated dose toxicity – local effects,dermal,LOAEL,0.045 mg/cm2,adverse effect observed,mouse "N,N-dimethyltetradecylamine N-oxide",3332-27-2,"Acute oral toxicity: Two reliable studies are available for C14 AO, both performed on the commercial product as supplied. The reported LD50 values (rat) are > 5000 mg/kg bw and > 2000 mg/kg bw (based on test substance) equivalent to > 1495 mg AO/kg bw and > 500 mg AO/kg bw, respectively. Data are also available for other members of the category, where testing has also been performed on the commercial product as supplied. In a study for C12-14 AO the reported LD50 (rat) was 3800 mg/kg bw, equivalent to 1064 mg AO/kg bw. Other studies performed using C12-14 AO reported LD50 (rat) values of >300 and >600 mg AO/kg bw. In a study performed using C14-16 AO the reported LD50 (rat) was 5600 mg/kg bw, equivalent to 1680 mg AO/kg bw.Acute dermal toxicity: No data are available for C14 AO, however two reliable studies are available for other members of the category. In the key study performed using C12-18 AO, the reported LD50 (rat) was > 2000 mg AO/kg bw.Acute inhalation toxicity: No studies are available. The substance is a solid with very low vapour pressure. It is manufactured and supplied as an aqueous solution, therefore there is no possibility of exposure to dust. It is used in some spraying applications, but it is expected that inhalation exposure from these applications will be low and hence the dermal route is more relevant. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0642c8df-605a-4203-b161-1578619f9f7f/documents/IUC5-7432ab58-f736-462b-89ac-fe02e9b0b776_f2fbd6f9-ef72-4111-9db5-27079f1e8fff.html,,,,,, "N,N-dimethyltetradecylamine N-oxide",3332-27-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0642c8df-605a-4203-b161-1578619f9f7f/documents/IUC5-7432ab58-f736-462b-89ac-fe02e9b0b776_f2fbd6f9-ef72-4111-9db5-27079f1e8fff.html,,oral,discriminating dose,"1,495 mg/kg bw",no adverse effect observed, "N,N-dimethyltetradecylamine N-oxide",3332-27-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0642c8df-605a-4203-b161-1578619f9f7f/documents/IUC5-7432ab58-f736-462b-89ac-fe02e9b0b776_f2fbd6f9-ef72-4111-9db5-27079f1e8fff.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Myristica fragrans, ext.",84082-68-8,Acute toxicity by inhalation: LC50 >4.9 mg/L (equivalent or similar to OECD 403) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4a74c40-ef3e-4d80-bd6c-80f21646b3e4/documents/IUC5-4aa23794-8890-42d5-8b4c-eca68a0a4458_aa1db488-5944-458e-bf16-5dc7a26cbcb0.html,,,,,, "Myristica fragrans, ext.",84082-68-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4a74c40-ef3e-4d80-bd6c-80f21646b3e4/documents/IUC5-4aa23794-8890-42d5-8b4c-eca68a0a4458_aa1db488-5944-458e-bf16-5dc7a26cbcb0.html,,inhalation,LC50,4.9 mg/m3,, N-(1-oxotetradecyl)sarcosine,52558-73-3," Repeated dose toxicity - oral (no OECD, 2-year study), rat: NOAEL ≥ 1000 mg/kg bw/day Repeated dose toxicity - oral (OECD 408, 90-day), rat: NOAEL ≥ 250 mg/kg bw/day RA from source substance Sodium N-lauroylsarcosinate (CAS 137-16-6) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fea01a1-ab48-4d46-a8a7-99693ebf664a/documents/30284536-ddd3-4005-bd14-696f3c8228e8_a7392fc2-4867-49a8-81e3-927761d7fb31.html,,,,,, N-(1-oxotetradecyl)sarcosine,52558-73-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fea01a1-ab48-4d46-a8a7-99693ebf664a/documents/30284536-ddd3-4005-bd14-696f3c8228e8_a7392fc2-4867-49a8-81e3-927761d7fb31.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat N-(1-oxotetradecyl)sarcosine,52558-73-3," Oral: Data waiving Inhalation: Data waiving Dermal: Data waiving As the registered substance is classified for its skin corrosion properties as Skin Corr. 1B (H314), no acute toxicity studies have to be conducted according to Regulation (EC) No. 1907/2006 (REACH), Annexes VII and VIII, Item 8.5, Column 2. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fea01a1-ab48-4d46-a8a7-99693ebf664a/documents/810e8bac-fe6c-4f0e-83c4-88b385dff2b3_a7392fc2-4867-49a8-81e3-927761d7fb31.html,,,,,, Tetradecanol,112-72-1," There are no repeated dose toxicity data on tetradecan-1-ol (CAS 112-72-1). A reliable 90-days dietary study in rats, using Alcohols, C14-15-branched and linear and reporting a NOAEL value greater than 3548 mg/kg bw/day based on no observed adverse effects, is read-across (Ito et al., 1978). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/144d24ea-75ac-43e0-a574-fefd8b255963/documents/dc0bc07a-b781-4124-9fad-5d51cde04ba9_a7190afd-f008-4bb9-8a68-32c727d953b6.html,,,,,, Tetradecanol,112-72-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/144d24ea-75ac-43e0-a574-fefd8b255963/documents/dc0bc07a-b781-4124-9fad-5d51cde04ba9_a7190afd-f008-4bb9-8a68-32c727d953b6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,548 mg/kg bw/day",,rat Tetradecanol,112-72-1," The key acute oral toxicity study for tetradecan-1-ol, conducted according to the now-deleted OECD Test Guideline 401 and in compliance with GLP, reports an LD50 value of >2000mg/kg (Safepharm Laboratories, 1996; rel 1). The key acute inhalation toxicity study with tetradecan-1-ol, conducted prior to OECD Test Guideline and GLP, reports an LC50 of >1.5 mg/L air in rat, following 1-hour whole body inhalation exposure to vapour (Scientific Associates, 1977; rel 2). The key acute dermal toxicity study for tetradecan-1-ol, conducted prior to OECD Test Guideline and GLP, reports an LD50 value of 8000-12000 mg/kg bw in rabbit (Scientific Associates 1977; rel 2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/144d24ea-75ac-43e0-a574-fefd8b255963/documents/73d9636e-34a3-4851-abbc-10e7d7e6b2e7_a7190afd-f008-4bb9-8a68-32c727d953b6.html,,,,,, Tetradecanol,112-72-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/144d24ea-75ac-43e0-a574-fefd8b255963/documents/73d9636e-34a3-4851-abbc-10e7d7e6b2e7_a7190afd-f008-4bb9-8a68-32c727d953b6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetradecanol,112-72-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/144d24ea-75ac-43e0-a574-fefd8b255963/documents/73d9636e-34a3-4851-abbc-10e7d7e6b2e7_a7190afd-f008-4bb9-8a68-32c727d953b6.html,,dermal,LD50,"8,000 mg/kg bw",no adverse effect observed, Tetradecanol,112-72-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/144d24ea-75ac-43e0-a574-fefd8b255963/documents/73d9636e-34a3-4851-abbc-10e7d7e6b2e7_a7190afd-f008-4bb9-8a68-32c727d953b6.html,,inhalation,LC50,"1,500 mg/m3",no adverse effect observed, (carboxylatomethyl)dimethyltetradecylammonium,2601-33-4, The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2332 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight) (Globally Harmonised Classification System Category 5 >2000 - 5000 mg/kg bodyweight). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f929ebe-1987-48d5-a511-799bda1e9fd9/documents/0c04c329-623c-498e-ba29-61ea271c6906_07ec1d89-0fed-4034-ab84-09a354a87098.html,,,,,, (carboxylatomethyl)dimethyltetradecylammonium,2601-33-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f929ebe-1987-48d5-a511-799bda1e9fd9/documents/0c04c329-623c-498e-ba29-61ea271c6906_07ec1d89-0fed-4034-ab84-09a354a87098.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetradecyl lactate,1323-03-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Low (not assignable). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Based on tests with shorter chain alkyl lactates. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Based on tests with shorter chain alkyl lactates. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): Low (not assignable). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5c3cf97-6c5e-4b64-ad86-4a0c912e3821/documents/e9f49d59-3c7a-453d-8828-b3ae1fd77e89_6f4cc660-a133-4068-97ae-087890013b9f.html,,,,,, Tetradecyl lactate,1323-03-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5c3cf97-6c5e-4b64-ad86-4a0c912e3821/documents/e9f49d59-3c7a-453d-8828-b3ae1fd77e89_6f4cc660-a133-4068-97ae-087890013b9f.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rat Tetradecyl lactate,1323-03-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5c3cf97-6c5e-4b64-ad86-4a0c912e3821/documents/e9f49d59-3c7a-453d-8828-b3ae1fd77e89_6f4cc660-a133-4068-97ae-087890013b9f.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,600 mg/m3,,rat Tetradecyl lactate,1323-03-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5c3cf97-6c5e-4b64-ad86-4a0c912e3821/documents/e9f49d59-3c7a-453d-8828-b3ae1fd77e89_6f4cc660-a133-4068-97ae-087890013b9f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,200 mg/m3,adverse effect observed,rat Tetradecyl lactate,1323-03-1," Justification for selection of acute toxicity – oral endpoint: Key studies performed with products containing tetradecyl lactate or C12 -C16 (even) lactates. Ceraphyl®50 containing C14 lactate, Ceraphyl®31 containing C12 -C16 (even) lactates and Ceraphyl®41 containing C12 -C15 lactates all have an oral LD50 of 20,000 mg/kg - inhalation endpoint: The inhalation LC50 of lactate esters is generally above 5000 mg/m3. – dermal endpoint: A combination of dodecyl and tridecyl lactates, linear and branched, proved to be non-toxic. Supporting test with other alkyl lactates confirm the low acute dermal toxicity of the product for registration. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5c3cf97-6c5e-4b64-ad86-4a0c912e3821/documents/IUC5-f53f538c-9f29-46e6-ad64-e3b64fcd27d3_6f4cc660-a133-4068-97ae-087890013b9f.html,,,,,, Tetradecyl lactate,1323-03-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5c3cf97-6c5e-4b64-ad86-4a0c912e3821/documents/IUC5-f53f538c-9f29-46e6-ad64-e3b64fcd27d3_6f4cc660-a133-4068-97ae-087890013b9f.html,,oral,LD50,"20,000 mg/kg bw",no adverse effect observed, Tetradecyl laurate,22412-97-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch code 2, pre-GLP studies with basic data on methods and results. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bca9cace-faa7-4314-a79d-508ae8b6693f/documents/IUC5-dbecb144-c834-4adc-a64d-e232ed2d53d1_2a7c37f9-b44d-48ea-bc32-0e06051973bb.html,,,,,, Tetradecyl laurate,22412-97-1,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bca9cace-faa7-4314-a79d-508ae8b6693f/documents/IUC5-dbecb144-c834-4adc-a64d-e232ed2d53d1_2a7c37f9-b44d-48ea-bc32-0e06051973bb.html,,oral,LD50,"8,600 mg/kg bw",adverse effect observed, Tetradecyl stearate,17661-50-6,"Oral: OECD 408, rat, NOAEL ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47428cbc-8694-4640-a914-16ee6a9ddfd2/documents/IUC5-6ecd394a-96dc-407b-b019-09d6f4c155e5_a27c2697-76ec-4116-850d-8db19eb29dab.html,,,,,, Tetradecyl stearate,17661-50-6,Oral: LD50 > 2000 mg/kg bw Dermal: LD50 > 2000 mg/kg bwInhalation: no data ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47428cbc-8694-4640-a914-16ee6a9ddfd2/documents/IUC5-ee1b4e46-880f-4e51-b3f1-88517719f13d_a27c2697-76ec-4116-850d-8db19eb29dab.html,,,,,, Tetradonium bromide,1119-97-7,"Data on relevant read-across substances: An oral 28D study in rats has been conducted on a 24-26% cetrimonium chloride solution with dose-levels of 0; 30; 100; and 300 mg/kg bw/d (corresponding to 0; 7.5; 25, and 75 mg/kg bw/d). The dose was given as gavage in 10 ml of water/ kg bw. The NOAEL was 25 mg/kg bw/d. At 75 mg/kg bw/d severe local effects in the stomach was noted (thickening of forestomach mucosa, sporatic ilceration. Slight increase in adrenal weight and slight decrease in spleen weight were also noted at this dose level but this was only considered as possible and not clear systemic effects.In an oral 1-year study rats were dosed via drinking water with cetrimonium bromide at 0; 10; 20 and 45 mg/kg bw/d. No histopathological findings were observed in the stomach (only organ subject to histopathological examination). At 45 mg/kg bw/d significant and persistent decrease in body weight was observed in male which was suggested to be due to lower observed efficiency of food conversion. The authors concluded that cetrimonium bromide may potentially prevent proper nutrition by increasing the rate of gastric emptying and intestinal transit and/or interfering with absorption of nutritional substances.In an evaluation of the study by the SCCS, a NOAEL of 10 mg/kg bw/d from this study was concluded.In a 28D dermal study with rabbits dosed on 25% of their body surface with 10 mg/kg bw/d ( 2 ml/kg bw/d) cetrimonium chloride no systemic effects were noted. However, the exposed skin showed mild to marked acanthosis with active mitosis, hyperkeratosis, and partial to extensive necrosis of the epidermis and hair follicles, partly with encrustation and exudate. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d39fa5d4-bc1c-494b-8df6-0ad450c1a2a9/documents/IUC5-54e841aa-5bc1-46e9-b017-1c4b3ccbefc1_7edea03e-b5ce-4a4e-bd3c-aa4ff290e464.html,,,,,, Tetradonium bromide,1119-97-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d39fa5d4-bc1c-494b-8df6-0ad450c1a2a9/documents/IUC5-54e841aa-5bc1-46e9-b017-1c4b3ccbefc1_7edea03e-b5ce-4a4e-bd3c-aa4ff290e464.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rabbit Tetradonium bromide,1119-97-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d39fa5d4-bc1c-494b-8df6-0ad450c1a2a9/documents/IUC5-54e841aa-5bc1-46e9-b017-1c4b3ccbefc1_7edea03e-b5ce-4a4e-bd3c-aa4ff290e464.html,Chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Tetradonium bromide,1119-97-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d39fa5d4-bc1c-494b-8df6-0ad450c1a2a9/documents/IUC5-54e841aa-5bc1-46e9-b017-1c4b3ccbefc1_7edea03e-b5ce-4a4e-bd3c-aa4ff290e464.html,Repeated dose toxicity – local effects,dermal,LOAEL,0.05 mg/cm2,adverse effect observed,rabbit Tetradonium bromide,1119-97-7,Data on acute oral toxicity of tetradonium bromide in rats indicate LD50 value of 390 mg/kg bw.Read-across data for acute inhalation toxicity on cetrimonium bromide includes a 30 minutes inhalation study with mice. The study indicates pulmonary irritation as dose-related reduced tidal volume and increase in respiratory frequency was found with a LOEC of 1.8 mg cetrimonium bromide/m3 and a NOEC of 0.57 mg cetrimonium bromide/m3. Initial signs of pulmonary inflammation were found at 19 mg cetrimonium bromide/m3 based on an increase in macrophages in BAL. Read-across data for acute dermal toxicity on cetrimonium chloride in rabbits. A dermal LD50 value of 4.3 ml/kg bw was found for cetrimonium chloride (corresponding to 2150 mg/kg bw ). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d39fa5d4-bc1c-494b-8df6-0ad450c1a2a9/documents/IUC5-ed8b9f6f-e75e-4e86-a965-117147f559c3_7edea03e-b5ce-4a4e-bd3c-aa4ff290e464.html,,,,,, Tetradonium bromide,1119-97-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d39fa5d4-bc1c-494b-8df6-0ad450c1a2a9/documents/IUC5-ed8b9f6f-e75e-4e86-a965-117147f559c3_7edea03e-b5ce-4a4e-bd3c-aa4ff290e464.html,,oral,LD50,390 mg/kg bw,adverse effect observed, Tetradonium bromide,1119-97-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d39fa5d4-bc1c-494b-8df6-0ad450c1a2a9/documents/IUC5-ed8b9f6f-e75e-4e86-a965-117147f559c3_7edea03e-b5ce-4a4e-bd3c-aa4ff290e464.html,,dermal,LD50,"2,150 mg/kg bw",adverse effect observed, Tetradonium bromide,1119-97-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d39fa5d4-bc1c-494b-8df6-0ad450c1a2a9/documents/IUC5-ed8b9f6f-e75e-4e86-a965-117147f559c3_7edea03e-b5ce-4a4e-bd3c-aa4ff290e464.html,,inhalation,discriminating conc.,1.8 mg/m3,adverse effect observed, "Myrtus communis, ext.",84082-67-7,"Acute toxicity, oral: LD50 > 5000 mg/kg bw (K, Rel.2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/058dcda3-91a3-49d3-b711-91e26b0ce524/documents/IUC5-27bfcf79-b129-4a8e-b103-8fb10a5190d4_d848b443-67c1-4bb9-a99d-02fffd67a5d0.html,,,,,, "Myrtus communis, ext.",84082-67-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/058dcda3-91a3-49d3-b711-91e26b0ce524/documents/IUC5-27bfcf79-b129-4a8e-b103-8fb10a5190d4_d848b443-67c1-4bb9-a99d-02fffd67a5d0.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "N,N'-methylenediacrylamide",110-26-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e35cd132-f629-4e5c-a21d-e09d01e522ce/documents/ba7895c3-6b77-4974-a24a-4dbddf8b8f4f_f25eebd8-8fd6-46fc-996a-64626a9cdc6a.html,,oral,LD50,50 mg/kg bw,adverse effect observed, "N,N'-methylenediacrylamide",110-26-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e35cd132-f629-4e5c-a21d-e09d01e522ce/documents/ba7895c3-6b77-4974-a24a-4dbddf8b8f4f_f25eebd8-8fd6-46fc-996a-64626a9cdc6a.html,,dermal,LD50,"1,141 mg/kg bw",adverse effect observed, "N,N'-methylenediacrylamide",110-26-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e35cd132-f629-4e5c-a21d-e09d01e522ce/documents/ba7895c3-6b77-4974-a24a-4dbddf8b8f4f_f25eebd8-8fd6-46fc-996a-64626a9cdc6a.html,,inhalation,discriminating conc.,12.1 mg/m3,no adverse effect observed, (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate,54381-16-7," Subchronic toxicity of N,N-bis (2-hydroxyethyl)-p-phenylenediamine sulfate was performed following OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents). Test substance was administered daily at dose levels of 0, 1, 4 and 20 mg/kg bw/day via oral gavage to rats for 91 d followed by 4 weeks recovery period. No treatment-related clinical observations were noted during the treatment or recovery phase of the study. There were no test substance-related effects on ophthalmic observations; effects on neurobehavioral assessment tests; effects on body weights or body weight changes; effects on food consumption; or effects on vaginal cytology. Test substance had no effect on clinical pathology test results. The mean percent sperm motility, caudal epididymal sperm count, and sperm morphology were not affected by treatment. No biologically meaningful differences were observed between the study groups.   Based on the results of the study, the No Observed Adverse Effect Level (NOAEL) following oral gavage administration of N,N-bis (2-hydroxyethyl)-PPD Sulf to rats at doses of 0, 1, 4, or 20 mg/kg/day for 91 d was determined to be 20 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa356c52-5199-44f3-9859-271dd26531d1/documents/a9438a2e-df6d-4169-8af8-e1ef54eadd13_40fa1418-abb1-4420-b386-9cbf29ad7e5d.html,,,,,, (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate,54381-16-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa356c52-5199-44f3-9859-271dd26531d1/documents/a9438a2e-df6d-4169-8af8-e1ef54eadd13_40fa1418-abb1-4420-b386-9cbf29ad7e5d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate,54381-16-7," According to the results on acute oral toxicity studies in rats and the value of LD50 from 107-427 mg/kg body weight , and the CLP criteria (1272/2008/EC), the category 3 - Danger should be considered. The substance is Toxic if swallowed H301. Based on the two calculations to determine the LC50 (inhalation route) and the LD50 (dermal route), the registered susbtance N,N-BIS(2-HYDROXYETHYL)-p-PHENYLENEDIAMINE SULFATE was classified as Category 3 for acute dermal and inhalation toxicity, respectively, H311 ""Toxic in contact with skin"" and H332 ""Toxic if inhaled"". ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa356c52-5199-44f3-9859-271dd26531d1/documents/1cb5f0f0-c629-4432-908c-1fd3b97d690d_40fa1418-abb1-4420-b386-9cbf29ad7e5d.html,,,,,, (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate,54381-16-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa356c52-5199-44f3-9859-271dd26531d1/documents/1cb5f0f0-c629-4432-908c-1fd3b97d690d_40fa1418-abb1-4420-b386-9cbf29ad7e5d.html,,oral,LD50,107.2 mg/kg bw,adverse effect observed, (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate,54381-16-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa356c52-5199-44f3-9859-271dd26531d1/documents/1cb5f0f0-c629-4432-908c-1fd3b97d690d_40fa1418-abb1-4420-b386-9cbf29ad7e5d.html,,dermal,LD50,428 mg/kg bw,adverse effect observed, (p-ammoniophenyl)bis(2-hydroxyethyl)ammonium sulphate,54381-16-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa356c52-5199-44f3-9859-271dd26531d1/documents/1cb5f0f0-c629-4432-908c-1fd3b97d690d_40fa1418-abb1-4420-b386-9cbf29ad7e5d.html,,inhalation,LC50,900 mg/m3,adverse effect observed, Butan-1-ol,71-36-3," oral  rat, 90 d: NOEL = 125 mg/kg bw (US EPA 1986; RL 1) dermal rabbit, 12 times in 21 days for 5 h, occlusive: drying of the skin, no systemic toxicity observed (Omie et al. 1949; RL 2) inhalation rat, 3 months (5 d/week, 5 h/d), vapour: Observed effect level = 320 mg/m^3, study not suitbale for NOAEL/LOAEL determination (Jajte et al. 2003; RL 2) n-Butyl acetate inhalation rat, 90 d, vapour: NOEL local/systemic = 2.35 mg/L, corresponding to 500 ppm, based on reduced body weight, transient CNS effects and necropsy in the olfactory epithelium (OPP/CMA 94030517 1996, RL 1) rat, 90 d, vapour: NOEL systemic = 2.35 mg/L, corresponding to 500 ppm, based on reduced body weight (OPP/CMA 297761P 1996, RL 1) The reported NOAELs of 500 ppm correspond to ca. 1.5 mg/L butan-1-ol. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5cf1e031-6ef4-4383-ba5c-df528f3e85b0/documents/IUC5-7c501fd5-26d0-4543-af5b-13a7139556ac_3354add3-fb68-44e8-9055-367f1d6e6cf5.html,,,,,, Butan-1-ol,71-36-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5cf1e031-6ef4-4383-ba5c-df528f3e85b0/documents/IUC5-7c501fd5-26d0-4543-af5b-13a7139556ac_3354add3-fb68-44e8-9055-367f1d6e6cf5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Butan-1-ol,71-36-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5cf1e031-6ef4-4383-ba5c-df528f3e85b0/documents/IUC5-7c501fd5-26d0-4543-af5b-13a7139556ac_3354add3-fb68-44e8-9055-367f1d6e6cf5.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,500 mg/m3",,rat Butan-1-ol,71-36-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5cf1e031-6ef4-4383-ba5c-df528f3e85b0/documents/IUC5-7c501fd5-26d0-4543-af5b-13a7139556ac_3354add3-fb68-44e8-9055-367f1d6e6cf5.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,500 mg/m3",adverse effect observed,rat Butan-1-ol,71-36-3," oral, LD50 rat ca. 2290 mg/kg bw (similar OECD TG 401; Union Carbide Corporation 1967) rat 2510 mg/kg/ bw (Jenner 1964) rat 4360 mg/kg/bw female (Union Carbide Corporation 1951) mouse 2680 mg/kg bw (Rumyanstev et al., 1979, Val. 4) rabbits 3500 mg/kg bw (Munch, 1972; Munch and Schwarze, 1925, Val. 4) Golden hamsters 1200 mg/kg bw (Dubina and Maksimov, 1976, Val. 4) Dogs, Minimum lethal dose: 1782 mg/kg bw (Von Oettingen, 1943, Val. 4) dermal, LD50 rabbits ca. 3430 mg/kg bw (similar OECD 402, Union Carbide Corporation 1951) inhalation rats (vapour) LC0 >= 17.76 mg/lL/ 4 h (similar OECD 403; BASF 1979) rats (vapour) IHT, 21.48 mg/L: no mortality within 7 h (similar OECD 403; BASF 1980) rats (vapour) LC0 > 24 mg/L/ 4 h; IHT: no mortality within 8 h (similar to OECD 403; Union Carbide Corporation 1951) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cf1e031-6ef4-4383-ba5c-df528f3e85b0/documents/IUC5-e9583ab0-7a4f-4258-9311-35a1fe86e55d_3354add3-fb68-44e8-9055-367f1d6e6cf5.html,,,,,, Butan-1-ol,71-36-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cf1e031-6ef4-4383-ba5c-df528f3e85b0/documents/IUC5-e9583ab0-7a4f-4258-9311-35a1fe86e55d_3354add3-fb68-44e8-9055-367f1d6e6cf5.html,,oral,LD50,"2,290 mg/kg bw",adverse effect observed, Butan-1-ol,71-36-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cf1e031-6ef4-4383-ba5c-df528f3e85b0/documents/IUC5-e9583ab0-7a4f-4258-9311-35a1fe86e55d_3354add3-fb68-44e8-9055-367f1d6e6cf5.html,,dermal,LD50,"3,434 mg/kg bw",adverse effect observed, Butan-1-ol,71-36-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cf1e031-6ef4-4383-ba5c-df528f3e85b0/documents/IUC5-e9583ab0-7a4f-4258-9311-35a1fe86e55d_3354add3-fb68-44e8-9055-367f1d6e6cf5.html,,inhalation,discriminating conc.,"17,760 mg/m3",no adverse effect observed, N-heptadecane,629-78-7, Repeated Dose Oral 90d - NOAEL ≥ 500 mg/kg bw/day for rats (OECD 408); BMDL = 1857 mg/Kg bw/day. Repeated Dose Inhalation 90d – NOAEC ≥ 6000 mg/m3 for rats (similar to OECD TG 413) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bed00230-f013-4ef3-b309-64d568ec302a/documents/5498889c-a1a4-4cff-88ed-5283c0bb2891_cae9472a-7da0-4694-bb36-f826efaced10.html,,,,,, N-heptadecane,629-78-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bed00230-f013-4ef3-b309-64d568ec302a/documents/5498889c-a1a4-4cff-88ed-5283c0bb2891_cae9472a-7da0-4694-bb36-f826efaced10.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat N-heptadecane,629-78-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bed00230-f013-4ef3-b309-64d568ec302a/documents/5498889c-a1a4-4cff-88ed-5283c0bb2891_cae9472a-7da0-4694-bb36-f826efaced10.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"6,000 mg/m3",,rat N-heptadecane,629-78-7, Oral LD50 (rat) > 5000 mg/Kg bw Inhalation LC50 (rat) >5991 mg/m³ Dermal LD50 (rabbit) > 2000 mg/Kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bed00230-f013-4ef3-b309-64d568ec302a/documents/010f8d35-791d-4c70-bc6d-7d6c449c5aec_cae9472a-7da0-4694-bb36-f826efaced10.html,,,,,, N-heptadecane,629-78-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bed00230-f013-4ef3-b309-64d568ec302a/documents/010f8d35-791d-4c70-bc6d-7d6c449c5aec_cae9472a-7da0-4694-bb36-f826efaced10.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, N-heptadecane,629-78-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bed00230-f013-4ef3-b309-64d568ec302a/documents/010f8d35-791d-4c70-bc6d-7d6c449c5aec_cae9472a-7da0-4694-bb36-f826efaced10.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, N-heptadecane,629-78-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bed00230-f013-4ef3-b309-64d568ec302a/documents/010f8d35-791d-4c70-bc6d-7d6c449c5aec_cae9472a-7da0-4694-bb36-f826efaced10.html,,inhalation,LC50,"5,991 mg/m3",no adverse effect observed, N-(4-aminophenyl)aniline,101-54-2,"The NOAEL in a 90-day feeding study with male rats was 1000 ppm (approximately 100 mg/kg bw/d) (Singh 1986). In this study, slight anemia, and changes in liver enzyme levels were seen at approximately 250 mg/kg bw/d (2500 ppm). At 5000 ppm (approximately 435 - 500 mg/kg bw/d) pathological changes in the liver were found at the histological examination, and at 7500 ppm (approximately 555- 750 mg/kg bw/d) histopathological changes were found in the testes (degeneration of seminiferous tubes). The NOAEL in a rat carcinogenicity study with dietary exposure over 78 weeks was 1200 ppm (approximately 60 -120 mg/kg bw/d; highest dose tested). Based on the findings from the 90 day feeding study (Singh 1986) and the supporting results from the carcinogenicity study, the NOAEL for repeated dose toxicity is assessed to be 100 mg/kg bw/d. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f826097-e57c-459d-bcff-30dfed24de3a/documents/IUC5-54e00b78-e646-4fa1-9b29-df5ac685f3d4_3ebe6dcf-6add-4368-93ab-933172c9bbcc.html,,,,,, N-(4-aminophenyl)aniline,101-54-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f826097-e57c-459d-bcff-30dfed24de3a/documents/IUC5-54e00b78-e646-4fa1-9b29-df5ac685f3d4_3ebe6dcf-6add-4368-93ab-933172c9bbcc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat N-(4-aminophenyl)aniline,101-54-2,"Methemoglobinemia was observed in cats after single oral administration of a non-lethal dose (Bayer AG 1957). In rats, the oral LD50 value was determined as 336 mg/kg bw in a GLP and guideline study (Monsanto Co. 1991b). Clinical signs of toxicity included ataxia, nasal, oral and ocular discharge, difficult breathing, and hypoactivity. The most notable internal necropsy observations for animals which died consisted of abnormalities of the digestive tract, urinary bladder, brain, lymph nodes, thymus and adrenal glands. In addition, observations of animals which survived showed also adverse effects on the digestive tract which may represent an irritant effect of the test material.The acute dermal toxicity of 4-ADPA was very low with an LD50 value of greater than 5000 mg/kg bw in rabbits. The only clinical signs noted in some animals were nasal and ocular discharge and single occurrence of red and/or swollen eyes. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f826097-e57c-459d-bcff-30dfed24de3a/documents/IUC5-39ff2aaf-e639-47ec-89d4-7f1da007c5e2_3ebe6dcf-6add-4368-93ab-933172c9bbcc.html,,,,,, N-(4-aminophenyl)aniline,101-54-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f826097-e57c-459d-bcff-30dfed24de3a/documents/IUC5-39ff2aaf-e639-47ec-89d4-7f1da007c5e2_3ebe6dcf-6add-4368-93ab-933172c9bbcc.html,,oral,LD50,336 mg/kg bw,, N-(4-aminophenyl)aniline,101-54-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f826097-e57c-459d-bcff-30dfed24de3a/documents/IUC5-39ff2aaf-e639-47ec-89d4-7f1da007c5e2_3ebe6dcf-6add-4368-93ab-933172c9bbcc.html,,dermal,LD50,"5,000 mg/kg bw",, 1-vinylhexahydro-2H-azepin-2-one,2235-00-9,"oral: accordingt to OECD TG 422, GLP: NOAEL(rat) = 40 mg/kg bw/d accordingt to OECD TG 408, GLP: NOAEL(rat) < 130 mg/kg bw/d   inhalation: accordingt to OECD TG 412, GLP: NOAEC(rat, systemic) = 58 mg/m³ air; NOAEC(rat, local) = 1 mg/m³ air accordingt to OECD TG 413, GLP: NOAEC(rat) = 58 mg/m³ ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b80188db-017c-4300-af48-1f759a852e84/documents/IUC5-e5e50fac-0a73-4f75-a6b1-cacfaf88ba07_6a4f4991-c892-4e6b-b573-445cba60f5ce.html,,,,,, 1-vinylhexahydro-2H-azepin-2-one,2235-00-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b80188db-017c-4300-af48-1f759a852e84/documents/IUC5-e5e50fac-0a73-4f75-a6b1-cacfaf88ba07_6a4f4991-c892-4e6b-b573-445cba60f5ce.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat 1-vinylhexahydro-2H-azepin-2-one,2235-00-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b80188db-017c-4300-af48-1f759a852e84/documents/IUC5-e5e50fac-0a73-4f75-a6b1-cacfaf88ba07_6a4f4991-c892-4e6b-b573-445cba60f5ce.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,58 mg/m3,,rat 1-vinylhexahydro-2H-azepin-2-one,2235-00-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b80188db-017c-4300-af48-1f759a852e84/documents/IUC5-e5e50fac-0a73-4f75-a6b1-cacfaf88ba07_6a4f4991-c892-4e6b-b573-445cba60f5ce.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,< 130 mg/kg bw/day,,rat 1-vinylhexahydro-2H-azepin-2-one,2235-00-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b80188db-017c-4300-af48-1f759a852e84/documents/IUC5-e5e50fac-0a73-4f75-a6b1-cacfaf88ba07_6a4f4991-c892-4e6b-b573-445cba60f5ce.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,58 mg/m3,,rat 1-vinylhexahydro-2H-azepin-2-one,2235-00-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b80188db-017c-4300-af48-1f759a852e84/documents/IUC5-e5e50fac-0a73-4f75-a6b1-cacfaf88ba07_6a4f4991-c892-4e6b-b573-445cba60f5ce.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1 mg/m3,adverse effect observed,rat 1-vinylhexahydro-2H-azepin-2-one,2235-00-9,"oral: similar to OECD TG 401, GLP: LD50 (rat) = 1114 mg/kg bw dermal:  according to OECD TG 402, GLP: LD50 (rabbit) = 1700 mg/kg bw/d inhalation: Inhalation Risk Test similar to OECD TG 403, non-GLP: LC50 (rat, 8h) > 1.6 mg/L air (saturated vapour) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b80188db-017c-4300-af48-1f759a852e84/documents/IUC5-2e4dd309-aca3-4918-ba0f-90e0ad43fa34_6a4f4991-c892-4e6b-b573-445cba60f5ce.html,,,,,, 1-vinylhexahydro-2H-azepin-2-one,2235-00-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b80188db-017c-4300-af48-1f759a852e84/documents/IUC5-2e4dd309-aca3-4918-ba0f-90e0ad43fa34_6a4f4991-c892-4e6b-b573-445cba60f5ce.html,,oral,LD50,"1,114 mg/kg bw",adverse effect observed, 1-vinylhexahydro-2H-azepin-2-one,2235-00-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b80188db-017c-4300-af48-1f759a852e84/documents/IUC5-2e4dd309-aca3-4918-ba0f-90e0ad43fa34_6a4f4991-c892-4e6b-b573-445cba60f5ce.html,,dermal,LD50,"1,700 mg/kg bw",adverse effect observed, 1-vinylimidazole,1072-63-5," A systemic NOAEL of 5 mg/kg/day was determined in a GLP compliant OECD422 study. In a sub-chronic oral toxicity study in rats, performed similar to OECD408, a LOAEL of 90 mg/kg bw/day for males and females was observed for 1-vinylimidazole. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f133b9cb-126b-4c88-ab89-e0abedb1dcd9/documents/IUC5-52d0c837-5c4c-42ea-8e41-817f2c47e5d3_2fed6974-e3c9-49a4-b982-ca19e53f81e3.html,,,,,, 1-vinylimidazole,1072-63-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f133b9cb-126b-4c88-ab89-e0abedb1dcd9/documents/IUC5-52d0c837-5c4c-42ea-8e41-817f2c47e5d3_2fed6974-e3c9-49a4-b982-ca19e53f81e3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat 1-vinylimidazole,1072-63-5, Acute oral toxicity data indicate a moderate toxicity in rats with an oral LD50 of ca. 1040 mg/kg bw. The inhalation of a saturated vapour-air-mixture represents an unlikely acute hazard. In the acute dermal toxicity study a LD50 value of > 2000 mg/kg bw was determined. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f133b9cb-126b-4c88-ab89-e0abedb1dcd9/documents/IUC5-a4e733d4-097a-46de-8472-4242a2d32754_2fed6974-e3c9-49a4-b982-ca19e53f81e3.html,,,,,, 1-vinylimidazole,1072-63-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f133b9cb-126b-4c88-ab89-e0abedb1dcd9/documents/IUC5-a4e733d4-097a-46de-8472-4242a2d32754_2fed6974-e3c9-49a4-b982-ca19e53f81e3.html,,oral,LD50,"1,040 mg/kg bw",adverse effect observed, 1-vinylimidazole,1072-63-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f133b9cb-126b-4c88-ab89-e0abedb1dcd9/documents/IUC5-a4e733d4-097a-46de-8472-4242a2d32754_2fed6974-e3c9-49a4-b982-ca19e53f81e3.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 1-vinyl-2-pyrrolidone,88-12-0,"Oral LD50: 834 to 1314 mg/kg bw (male/female rat); 1022 mg/kg bw (male/female rat);Dermal LD50: between 1043 and 4127 mg/kg bw (male/female rat) in a reliable study, less reliable study result: LD50=560 mg/kg bw (male/female rabbit); Inhalation LC50 = 3070 mg/m3 (male/female rat). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d00d4994-0f98-4c8c-99da-293e97a40b68/documents/IUC5-88012612-fd30-4b26-bc4f-975d7ba4dc7f_cfb53ac4-ffcf-44da-96cc-250958e85efa.html,,,,,, 1-vinyl-2-pyrrolidone,88-12-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d00d4994-0f98-4c8c-99da-293e97a40b68/documents/IUC5-88012612-fd30-4b26-bc4f-975d7ba4dc7f_cfb53ac4-ffcf-44da-96cc-250958e85efa.html,,oral,LD50,"1,022 mg/kg bw",, 1-vinyl-2-pyrrolidone,88-12-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d00d4994-0f98-4c8c-99da-293e97a40b68/documents/IUC5-88012612-fd30-4b26-bc4f-975d7ba4dc7f_cfb53ac4-ffcf-44da-96cc-250958e85efa.html,,dermal,LD50,"2,350 mg/kg bw",, 1-vinyl-2-pyrrolidone,88-12-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d00d4994-0f98-4c8c-99da-293e97a40b68/documents/IUC5-88012612-fd30-4b26-bc4f-975d7ba4dc7f_cfb53ac4-ffcf-44da-96cc-250958e85efa.html,,inhalation,LC50,"3,070 mg/m3",, "7-(2-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyloxy)-2,3-dihydro-4',5,7-trihydroxyflavone",10236-47-2," Repeated dose toxicity: oral. Key study. Method according to ‘‘Technical Guideline for Long Term Toxicity Test of chemical drugs’’ (SFDA, 2005), similar to OECD 408, GLP study (no certificate available). The oral NOAEL for rats is 1250 mg/kg bw/d after 90 d. Key study. Method according to ‘‘Technical Guideline for Long Term Toxicity Test of chemical drugs’’ (SFDA, 2005), similar to OECD 408, GLP study (no certificate available). The oral NOAEL for rats is 1250 mg/kg bw/d after 6 months. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63678fa7-6bbe-4331-81f4-af8a44e250df/documents/IUC5-e20a7963-128d-49b0-b75d-f85b1aca210f_0b73cbe4-f5ce-4341-8409-8c50505cb0a8.html,,,,,, "7-(2-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyloxy)-2,3-dihydro-4',5,7-trihydroxyflavone",10236-47-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63678fa7-6bbe-4331-81f4-af8a44e250df/documents/IUC5-e20a7963-128d-49b0-b75d-f85b1aca210f_0b73cbe4-f5ce-4341-8409-8c50505cb0a8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,250 mg/kg bw/day",,rat "7-(2-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyloxy)-2,3-dihydro-4',5,7-trihydroxyflavone",10236-47-2," Acute toxicity: oral. Key study. Method according to the ‘‘Technical Guideline for Acute Toxicity Test of chemical drugs’’(SFDA, 2004, China), similar to OECD 420, GLP study (no certificate available). The test item has an oral LD50 > 16g/kg for rats. Acute toxicity: dermal. Key study. Method according to OECD 402, GLP study. The test item has a dermal route LD50 > 2000 mg/kg bw in rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63678fa7-6bbe-4331-81f4-af8a44e250df/documents/IUC5-b4e9c761-0be8-46ff-a893-2fb4f1560f30_0b73cbe4-f5ce-4341-8409-8c50505cb0a8.html,,,,,, "7-(2-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyloxy)-2,3-dihydro-4',5,7-trihydroxyflavone",10236-47-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63678fa7-6bbe-4331-81f4-af8a44e250df/documents/IUC5-b4e9c761-0be8-46ff-a893-2fb4f1560f30_0b73cbe4-f5ce-4341-8409-8c50505cb0a8.html,,oral,LD50,"16,000 mg/kg bw",no adverse effect observed, "7-(2-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyloxy)-2,3-dihydro-4',5,7-trihydroxyflavone",10236-47-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63678fa7-6bbe-4331-81f4-af8a44e250df/documents/IUC5-b4e9c761-0be8-46ff-a893-2fb4f1560f30_0b73cbe4-f5ce-4341-8409-8c50505cb0a8.html,,dermal,LD50,"2,000 mg/kg bw",, "(S)-7-[[2-O-6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-2,3-dihydro-5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-4H-1-benzopyran-4-one",13241-33-3," Weight of evidence: The oral sub-chronic NOAEL of the test item is deemed to be ca. 750 mg/kg bw/d (worst-case scenario), based on the available information from supporting analogue substances: - Read-across from supporting substance (structural analogue or surrogate). Source: Key study. Method similar to OECD 408. The NOAEL of the analogue substance neohesperidin dihydrochalcone for oral sub-chronic toxicity in rats was found to be ca. 4000 mg/kg bw/d (5% in diet), and the NOEL ca. 750 mg/kg bw (1%). Based on the read-across approach, the NOAEL of the target substance is ca. 3987 mg/kg bw/d. - Read-across from supporting substance (structural analogue or surrogate). Source: Study well documented, meets generally accepted scientific criteria (no guideline available). The NOAEL for the analogue substance hesperidin was set to 1% (ca. 750 mg) by weight per day in food. Based on the read-across approach, the NOAEL for oral toxicity of neohesperidin in rats can be set to ca. 750 mg/kg bw per day. - Read-across from supporting substance (structural analogue or surrogate). Source: Method similar to OECD 408. The NOAEL of the analogue substance methyl hesperidin for oral sub-chronic toxicity in mice was found to be 5% in diet. Based on the read-across approach, the NOAEL of the target substance is 4.88% in diet. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d9382fa-da91-4dca-a595-e70cf92bd916/documents/IUC5-2a6dc026-761a-40a1-a79d-61d7be864db8_0012728d-711f-4a0f-9d56-750b9fd295be.html,,,,,, "(S)-7-[[2-O-6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-2,3-dihydro-5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-4H-1-benzopyran-4-one",13241-33-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d9382fa-da91-4dca-a595-e70cf92bd916/documents/IUC5-2a6dc026-761a-40a1-a79d-61d7be864db8_0012728d-711f-4a0f-9d56-750b9fd295be.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "(S)-7-[[2-O-6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-2,3-dihydro-5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-4H-1-benzopyran-4-one",13241-33-3," Oral route: Weight of evidence: - Read-across from analogue substance. Source: Method similar to OECD 420. Based on read-across approach, the oral LD50 in rats for the target substance was determined to be >= 4984 mg/kg bw. - Read-across from analogue substance. Source: Method similar to OECD 420. Based on read-across approach, the oral LD50 in rats for the target substance was determined to be >= 4984 mg/kg bw. - Read-across from analogue substance. Source: Method similar to OECD 474. Based on read-across approach, the oral LD50 in rats for the target substance was determined to be >= 4984 mg/kg bw. Dermal route: - Key study. Method according to OECD 402 (limit test), GLP study. No mortality or systemic clinical signs related to the administration of the test item were observed throughout the study. The test item was found to be non toxic, with an LD50 > 2000 mg/kg bw. Inhalation route: - Data waiving (other justification): According to Regulation (EC) No. 1907/2006, Annex VIII, 8.5.3, column 2, the acute toxicity by inhalation route is not required, as both oral and dermal studies are available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d9382fa-da91-4dca-a595-e70cf92bd916/documents/IUC5-d1cb9d59-bb34-4037-ba7b-df69a62dc46e_0012728d-711f-4a0f-9d56-750b9fd295be.html,,,,,, "(S)-7-[[2-O-6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-2,3-dihydro-5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-4H-1-benzopyran-4-one",13241-33-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d9382fa-da91-4dca-a595-e70cf92bd916/documents/IUC5-d1cb9d59-bb34-4037-ba7b-df69a62dc46e_0012728d-711f-4a0f-9d56-750b9fd295be.html,,oral,LD50,"4,984 mg/kg bw",no adverse effect observed, "(S)-7-[[2-O-6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-2,3-dihydro-5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-4H-1-benzopyran-4-one",13241-33-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d9382fa-da91-4dca-a595-e70cf92bd916/documents/IUC5-d1cb9d59-bb34-4037-ba7b-df69a62dc46e_0012728d-711f-4a0f-9d56-750b9fd295be.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-[4-[[2-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-2,6-dihydroxyphenyl]-3-(3-hydroxy-4-methoxyphenyl)propan-1-one",20702-77-6," Repeated dose toxicity: oral. Key study. Method similar to OECD 408 (no GLP). The test item has a sub-chronic oral NOAEL of ca. 4000 mg/kg bw/d (5% in diet) in rats, and a NOEL of ca. 750 mg/kg bw/d (1% in diet). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1f313ede-4981-402e-9261-325218d1c909/documents/4f88b0eb-23d5-4e4d-bcda-fcc717f847d4_c9016445-eaa1-45fd-8342-05871b9babb8.html,,,,,, "1-[4-[[2-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-2,6-dihydroxyphenyl]-3-(3-hydroxy-4-methoxyphenyl)propan-1-one",20702-77-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1f313ede-4981-402e-9261-325218d1c909/documents/4f88b0eb-23d5-4e4d-bcda-fcc717f847d4_c9016445-eaa1-45fd-8342-05871b9babb8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"4,000 mg/kg bw/day",,rat "1-[4-[[2-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-2,6-dihydroxyphenyl]-3-(3-hydroxy-4-methoxyphenyl)propan-1-one",20702-77-6," Oral route: - Key study. Method similar to OECD 420 (non-GLP). The oral LD50 in rats for the substance was found to be ≥ 5000 mg/kg bw. - Key study. Method similar to OECD 420 (non-GLP). The oral LD50 in rats for the substance was found to be ≥ 5000 mg/kg bw. - Supporting study: Method similar to OECD 474 (non-GLP). During an in vivo micronucleus assay, the acute oral LD50 in rats for the substance was found to be ≥ 5000 mg/kg bw. Based on the available data, the substance is considered to be non-toxic, with an LD50 ≥ 5000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f313ede-4981-402e-9261-325218d1c909/documents/cb12c2e1-2acf-4495-8ec3-688e41a9f07f_c9016445-eaa1-45fd-8342-05871b9babb8.html,,,,,, "1-[4-[[2-O-(6-deoxy-α-L-mannopyranosyl)-β-D-glucopyranosyl]oxy]-2,6-dihydroxyphenyl]-3-(3-hydroxy-4-methoxyphenyl)propan-1-one",20702-77-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f313ede-4981-402e-9261-325218d1c909/documents/cb12c2e1-2acf-4495-8ec3-688e41a9f07f_c9016445-eaa1-45fd-8342-05871b9babb8.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, (±)-neomenthol,3623-51-6," No studies are available with (±)-neomenthol. Reliable data are available with the read across menthol (CAS 89 -78 -1). No effects were observed in life-time (103 weeks) studies in rats and mice by using menthol up to the highest tested dose corresponding to 375 mg/kg bw/day for the rat and 667 mg/kg bw/day for the mouse. In a 90-day feeding study with menthol the NOAEL was 937 mg/kg bw/day for rats (highest dose tested). In a 90-day feeding study the NOAEL was 1250 mg/kg bw/day for mice based on slightly reduced body weight gain. As no sytemic effects were seen in both 103 weeks repeated dose toxicity studies applied by oral route, repeated dose studies via dermal or inhalative route do not appear to be scientifically justified. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1fa657f0-f8b5-44e8-aab5-49f1755b3c27/documents/1210dffc-9352-4836-ac21-f3db2e2bf43f_b376ca27-b673-475f-a68e-7849c49930e7.html,,,,,, (±)-neomenthol,3623-51-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1fa657f0-f8b5-44e8-aab5-49f1755b3c27/documents/1210dffc-9352-4836-ac21-f3db2e2bf43f_b376ca27-b673-475f-a68e-7849c49930e7.html,Chronic toxicity – systemic effects,oral,NOAEL,375 mg/kg bw/day,,rat (±)-neomenthol,3623-51-6," No data are availabe for (±)-neomenthol, therefore reliable data from the menthol category group were used. Oral, rat (WoE): LD50: 2046 mg/kg bw Dermal, rat: LD50 >5000 mg/kg bw (RL4 not sufficient for classification) Inhalation, rat: LC50 (aerosol, 4 h): 5289 mg/m³ ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fa657f0-f8b5-44e8-aab5-49f1755b3c27/documents/140ac13c-639a-41b8-947e-aed8f02088d0_b376ca27-b673-475f-a68e-7849c49930e7.html,,,,,, (±)-neomenthol,3623-51-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fa657f0-f8b5-44e8-aab5-49f1755b3c27/documents/140ac13c-639a-41b8-947e-aed8f02088d0_b376ca27-b673-475f-a68e-7849c49930e7.html,,oral,LD50,"2,046 mg/kg bw",adverse effect observed, (±)-neomenthol,3623-51-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fa657f0-f8b5-44e8-aab5-49f1755b3c27/documents/140ac13c-639a-41b8-947e-aed8f02088d0_b376ca27-b673-475f-a68e-7849c49930e7.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, (±)-neomenthol,3623-51-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fa657f0-f8b5-44e8-aab5-49f1755b3c27/documents/140ac13c-639a-41b8-947e-aed8f02088d0_b376ca27-b673-475f-a68e-7849c49930e7.html,,inhalation,LC50,"5,289 mg/m3",adverse effect observed, "2,2-dimethylpropane-1,3-diol",126-30-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3f67c2f-3e88-4ba1-b5c5-47f2ede059ae/documents/IUC5-85cfbcaf-4c47-4f9b-9720-9524d70006e4_47550969-6f7e-4444-909e-a5ab73d8491d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2-dimethyl-1,3-propanediyl didecanoate",27841-06-1," Short-term repeated dose toxicity: oral (read-across, equivalent/similar to OECD 407): NOAEL >= 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0498d82-4983-4c86-a284-d018f1488c3a/documents/b80a3887-ea83-418d-95cf-4b2ec1c18c5d_3bfc984d-0c4c-4f18-ac9c-b0c3a292cc22.html,,,,,, "2,2-dimethyl-1,3-propanediyl didecanoate",27841-06-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0498d82-4983-4c86-a284-d018f1488c3a/documents/b80a3887-ea83-418d-95cf-4b2ec1c18c5d_3bfc984d-0c4c-4f18-ac9c-b0c3a292cc22.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2-dimethyl-1,3-propanediyl didecanoate",27841-06-1," Acute toxicity: oral (target substance and read-across, equivalent/similar to OECD 401): LD50 (rat, m/f) > 2000 mg/kg bw Acute toxicity: dermal and inhalation: Data waived according to Annex VIII, Item 8.5, Column 2, of Regulation (EC) No. 1907/2006 (REACH). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0498d82-4983-4c86-a284-d018f1488c3a/documents/9725b8f0-c58b-4347-9c0d-ce62401c8787_3bfc984d-0c4c-4f18-ac9c-b0c3a292cc22.html,,,,,, "Decanoic acid, mixed esters with neopentyl glycol and octanoic acid",70693-32-2,All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/28b20376-30f2-42b5-9303-e6d5c4ed7c91/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_29e2ba65-03a5-4db3-b871-3f4b23493910.html,,,,,, "Decanoic acid, mixed esters with neopentyl glycol and octanoic acid",70693-32-2,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28b20376-30f2-42b5-9303-e6d5c4ed7c91/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_29e2ba65-03a5-4db3-b871-3f4b23493910.html,,,,,, "2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate",28510-23-8,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object showing an overview of the strategy for all substances within the polyol esters category.   Oral (subacute, OECD 422, GLP, rat, m/f): NOAEL (systemic toxicity) ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9060e52d-0155-4560-8fb2-e7691ada3c02/documents/c978fafd-10e8-44f5-bb2c-8f46ebddd5d0_35f4b87a-cd47-4b6b-8f6a-1db9bd68ea7f.html,,,,,, "2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate",28510-23-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9060e52d-0155-4560-8fb2-e7691ada3c02/documents/c978fafd-10e8-44f5-bb2c-8f46ebddd5d0_35f4b87a-cd47-4b6b-8f6a-1db9bd68ea7f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat "2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate",28510-23-8,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object showing an overview of the strategy for all substances within the polyol esters category. Acute oral toxicity: equivalent to OECD 401 and in compliance with GLP, RL2: LD50>2000 mg/kg bwAcute inhalation toxicity: No data availableAcute dermal toxicity: No data available ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9060e52d-0155-4560-8fb2-e7691ada3c02/documents/05dcadc2-407f-48cd-bc99-9945dc31efcb_35f4b87a-cd47-4b6b-8f6a-1db9bd68ea7f.html,,,,,, "2,2-dimethylpropane-1,3-diyl 2-ethylhexanoate",28510-23-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9060e52d-0155-4560-8fb2-e7691ada3c02/documents/05dcadc2-407f-48cd-bc99-9945dc31efcb_35f4b87a-cd47-4b6b-8f6a-1db9bd68ea7f.html,,oral,LD50,">=2,000 mg/kg bw",no adverse effect observed, "1,3-Propanediol, 2,2-dimethyl-, C5-9 carboxylates",85711-80-4,"Repeated dose toxicity: Oral NOAEL (rat, m/f): >= 1000 mg/kg bw/day (OECD 407, GLP, analogue approach) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d02e8b4-ca87-406e-adf6-4bcd35d3247f/documents/IUC5-d0677ee0-7623-4b41-8a77-1b652353fde6_974e7669-e6ba-45ca-93da-7ac1907d58a0.html,,,,,, "1,3-Propanediol, 2,2-dimethyl-, C5-9 carboxylates",85711-80-4,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (WoE, analogue approach)Acute toxicity: Inhalation LC50 (rat, m/f): > 5.0 mg/L air (WoE, analogue approach)Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (WoE, analogue approach) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d02e8b4-ca87-406e-adf6-4bcd35d3247f/documents/IUC5-4d66cbc8-6ab4-41fd-85f4-7d9bc7ec6284_974e7669-e6ba-45ca-93da-7ac1907d58a0.html,,,,,, "Heptanoic acid, ester with 2,2-dimethyl-1,3-propanediol",68855-18-5,All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41eb8993-9ab3-4673-ad78-bd78cfeda02a/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_b54a6192-288a-4b7f-bf00-8362481d1581.html,,,,,, "Heptanoic acid, ester with 2,2-dimethyl-1,3-propanediol",68855-18-5,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41eb8993-9ab3-4673-ad78-bd78cfeda02a/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_b54a6192-288a-4b7f-bf00-8362481d1581.html,,,,,, "Isooctadecanoic acid, 1,1'-(2,2-dimethyl-1,3-propanediyl) ester",109884-54-0,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category. Oral: OECD 407, rat, NOAEL (m/f) =1450/1613 mg/kg bw/day Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises adequate, reliable (Klimisch score 2 due to read-across) and consistent studies, from reference substances with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products, similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.6, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7763bca0-1dac-4df8-97af-540d2ae1d811/documents/IUC5-f5bca92d-3c64-4b5f-bc40-e0496317d293_e2e3b7b1-444c-4699-b040-df03666f3c90.html,,,,,, "Isooctadecanoic acid, 1,1'-(2,2-dimethyl-1,3-propanediyl) ester",109884-54-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7763bca0-1dac-4df8-97af-540d2ae1d811/documents/IUC5-f5bca92d-3c64-4b5f-bc40-e0496317d293_e2e3b7b1-444c-4699-b040-df03666f3c90.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,450 mg/kg bw/day",,rat "Isooctadecanoic acid, 1,1'-(2,2-dimethyl-1,3-propanediyl) ester",109884-54-0,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.Oral (OECD 423): LD50 >5000 mg/kg bw Inhalation (OECD 436): LC50 >5.22 mg/LDermal: Waiving Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The available information comprises an adequate, reliable study (Klimisch score 2 due to read-across) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on similar functional groups and similar precursors/breakdown products (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7763bca0-1dac-4df8-97af-540d2ae1d811/documents/IUC5-402db38f-2e90-4367-af23-44440cc6fba6_e2e3b7b1-444c-4699-b040-df03666f3c90.html,,,,,, "2,2-dimethylpropane-1,3-diyl dinonanoate",15834-05-6, A NOAEL of 1000 mg/kg bw/d was determined for the test item based on effects observed in a combined repeated dose / reprotox screening test (OECD422). ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/42193edb-b82d-4be2-b629-f6b2755870a3/documents/f9a49184-41ad-40bd-8497-9403209657a3_40a30cbc-214d-49ac-9b93-c156fb907a09.html,,,,,, "2,2-dimethylpropane-1,3-diyl dinonanoate",15834-05-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/42193edb-b82d-4be2-b629-f6b2755870a3/documents/f9a49184-41ad-40bd-8497-9403209657a3_40a30cbc-214d-49ac-9b93-c156fb907a09.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2-dimethylpropane-1,3-diyl dinonanoate",15834-05-6," Two recent GLP studies have been performed on a similar substance according to OECD guidelines for acute oral and dermal toxicity (Salvador, 2014 and 2014a). Both studies did not show any adverse effects up to a concentration of 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42193edb-b82d-4be2-b629-f6b2755870a3/documents/92fe265b-3c24-44b9-8ddd-d0855536d147_40a30cbc-214d-49ac-9b93-c156fb907a09.html,,,,,, "2,2-dimethylpropane-1,3-diyl dinonanoate",15834-05-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42193edb-b82d-4be2-b629-f6b2755870a3/documents/92fe265b-3c24-44b9-8ddd-d0855536d147_40a30cbc-214d-49ac-9b93-c156fb907a09.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2-dimethylpropane-1,3-diyl dinonanoate",15834-05-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42193edb-b82d-4be2-b629-f6b2755870a3/documents/92fe265b-3c24-44b9-8ddd-d0855536d147_40a30cbc-214d-49ac-9b93-c156fb907a09.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "(Z)-3,7-dimethylocta-2,6-dienal",106-26-3,"Chronic oral toxicity (similar to OECD TG 453, according to GLP; NTP 2003c-d)rat: NOAEL 100 mg/kg bw/dmouse: LOAEL 60 mg/kg bw/d for femalesSubchronic inhalation toxicity (Weight of evidence: Gaworski 1992,1993)rat: NOAEC 34 ppm = 215 mg/m3 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2af308ce-d0f8-4f9f-84ca-5252f1d5dd8e/documents/IUC5-1ba2ce76-2aa6-48d1-b424-e252bf8e5d6d_06c081d8-d426-414f-a4c1-5b268731f36b.html,,,,,, "(Z)-3,7-dimethylocta-2,6-dienal",106-26-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2af308ce-d0f8-4f9f-84ca-5252f1d5dd8e/documents/IUC5-1ba2ce76-2aa6-48d1-b424-e252bf8e5d6d_06c081d8-d426-414f-a4c1-5b268731f36b.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,60 mg/kg bw/day,, "(Z)-3,7-dimethylocta-2,6-dienal",106-26-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2af308ce-d0f8-4f9f-84ca-5252f1d5dd8e/documents/IUC5-1ba2ce76-2aa6-48d1-b424-e252bf8e5d6d_06c081d8-d426-414f-a4c1-5b268731f36b.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,215 mg/m3,, "(Z)-3,7-dimethylocta-2,6-dienal",106-26-3,Acute oral toxicity: LD50 rat 6800 mg/kgAcute dermal toxicity: LD50 rat > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2af308ce-d0f8-4f9f-84ca-5252f1d5dd8e/documents/IUC5-5123ca9a-da4e-4212-ac86-d5482625d11b_06c081d8-d426-414f-a4c1-5b268731f36b.html,,,,,, Nerol,106-25-2,NOAEL for systemic toxicity = 6000 ppm for both males and females (equivalent to 374 mg/kg bw/day) based on reduced bodyweight gain at 12000 ppm. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a0b85b1-8df2-4672-97f6-4a65cac57586/documents/IUC5-c04ba65d-41e8-4f63-9a97-9f953f16db54_dbc7deae-c247-444f-865d-97fffe496134.html,,,,,, Nerol,106-25-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a0b85b1-8df2-4672-97f6-4a65cac57586/documents/IUC5-c04ba65d-41e8-4f63-9a97-9f953f16db54_dbc7deae-c247-444f-865d-97fffe496134.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,374 mg/kg bw/day,,rat Nerol,106-25-2,"In an acute oral toxicity study performed similarly to OECD guideline 401 in rats, LD50 = 4500 mg/kg bw.In an acute dermal toxicity study performed similarly to OECD guideline 402 in rabbits, LD50 > 5000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a0b85b1-8df2-4672-97f6-4a65cac57586/documents/IUC5-cc774f24-c709-4cba-a712-97d94f8f6811_dbc7deae-c247-444f-865d-97fffe496134.html,,,,,, Nerol,106-25-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a0b85b1-8df2-4672-97f6-4a65cac57586/documents/IUC5-cc774f24-c709-4cba-a712-97d94f8f6811_dbc7deae-c247-444f-865d-97fffe496134.html,,oral,LD50,"4,500 mg/kg bw",no adverse effect observed, Nerol,106-25-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a0b85b1-8df2-4672-97f6-4a65cac57586/documents/IUC5-cc774f24-c709-4cba-a712-97d94f8f6811_dbc7deae-c247-444f-865d-97fffe496134.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,7,11-trimethyldodeca-1,6,10-trien-3-ol,mixed isomers",7212-44-4,"Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (according to OECD TG 422 and GLP) (BASF 96R0466/09052): NOAEL males = 4000 ppm (approx 270 mg nerolidol/kg bw/d ) NOAEL females = 1500 ppm (approx 105, 120 or 193 mg nerolidol/kg bw/d) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f7aaea2c-05f7-4dbd-9508-aadad89a5ed4/documents/IUC5-ff81b819-99a1-4f94-ae4c-c433f0264680_2906198a-259b-4d79-ab82-4688a2e22884.html,,,,,, "3,7,11-trimethyldodeca-1,6,10-trien-3-ol,mixed isomers",7212-44-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f7aaea2c-05f7-4dbd-9508-aadad89a5ed4/documents/IUC5-ff81b819-99a1-4f94-ae4c-c433f0264680_2906198a-259b-4d79-ab82-4688a2e22884.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Neryl acetate,141-12-8," An oral diet repeated dose toxicity study (combined with a reproduction/developmental toxicity screening test) was conducted with NERYL ACETATE according to guideline OECD 422 and in compliance with GLP. The NOAEL for systemic  toxicity was 7500 ppm, the highest dose tested, corresponding to 440 mg/kg bw/day for males, 465 mg/kg bw/day for toxicity phase females and 484 mg/kg/day for reproductive phase females during pre-mating period. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da0cfa34-3700-4798-87a7-a01ad6f90336/documents/9cd9aeb3-9b64-4760-a86c-0bdc67ddc999_94058595-fd73-4ca6-bf21-0bd17c61b0dd.html,,,,,, Neryl acetate,141-12-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da0cfa34-3700-4798-87a7-a01ad6f90336/documents/9cd9aeb3-9b64-4760-a86c-0bdc67ddc999_94058595-fd73-4ca6-bf21-0bd17c61b0dd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,440 mg/kg bw/day,,rat Neryl acetate,141-12-8," In accordance with a study conducted according to Guideline OECD 423, the oral LD50 of the test substance can be considered > 5000 mg/kg bw in rats. In accordance with a study conducted according to Guideline OECD 402, the dermal LD50 of the test substance is > 5000 mg/kg bw in rabbit. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da0cfa34-3700-4798-87a7-a01ad6f90336/documents/d9169d77-1df8-42f2-8d28-9554766ed375_94058595-fd73-4ca6-bf21-0bd17c61b0dd.html,,,,,, Neryl acetate,141-12-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da0cfa34-3700-4798-87a7-a01ad6f90336/documents/d9169d77-1df8-42f2-8d28-9554766ed375_94058595-fd73-4ca6-bf21-0bd17c61b0dd.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Neryl acetate,141-12-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da0cfa34-3700-4798-87a7-a01ad6f90336/documents/d9169d77-1df8-42f2-8d28-9554766ed375_94058595-fd73-4ca6-bf21-0bd17c61b0dd.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Nicotinamide,98-92-0,"The key subacute toxicity study (oral) was carried out according to EU Method B.7 and OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents). The results indicate the very low toxicity. Even at a dose of 1000 mg/kg daily administered for 4 weeks the liver as the main target organ is only slightly affected. All changes are reversible after the end of exposure to unphysiologically high levels of test item. No adverse effects were observed at 215 mg/kg bw/day.According to REACH Annex VIII column 1 and 2 experimental studies with dosing via the inhalation and dermal route were waived. The sub-chronic toxicity study requirement according to REACH Annex IX was waived based on a weight of evidence approach. Repeated dose toxicity was previously reviewed by the European Commission Scientific Committee on Food, the EFSA Panel on Additives and Products or Substances used in Animal Feed, the US FDA and the UK Food Standards Agency Expert Group on Vitamins and Minerals. An OECD SIDS review concluded that Nicotinamide is essential for human and animal health and that based on the available information, the substance does not present a hazard to human health. The weight of evidence assessment revealed a human NOAEL in the range of 25 mg/kg bw/day. An uncertainty factor of 2 has been used to allow for the fact that adults may eliminate Nicotinamide more slowly than the study groups, many of which were children, and that data for children would not reflect the full extent of intersubject variability that could occur in an older population. The upper level for Nicotinamide is established at 12.5 mg/kg bw/day or approximately 900 mg/day for adults. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/81331048-f0b1-402b-9a98-a23603b265f8/documents/IUC5-78394396-ad5a-4d7c-991f-dbe2a4bbd927_e501f08f-62ac-42c3-b9cf-c9cbe1d7d2b0.html,,,,,, Nicotinamide,98-92-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/81331048-f0b1-402b-9a98-a23603b265f8/documents/IUC5-78394396-ad5a-4d7c-991f-dbe2a4bbd927_e501f08f-62ac-42c3-b9cf-c9cbe1d7d2b0.html,Chronic toxicity – systemic effects,oral,NOAEL,12.5 mg/kg bw/day,,other:human Nicotinamide,98-92-0,"The test item was considered practically non-toxic following acute exposure via the oral, inhalation or dermal route. The key acute oral toxicity study was carried out in rats according to EU Method B.1 tris and OECD Guideline 423 (Acute Oral Toxicity - Acute Toxic Class Method). The acute oral LD50 was estimated to be > 2500 mg/kg bw. The NOAEL was determined to be 2000 mg/kg bw. Supporting studies in rat, mouse and rabbit confirmed that the test material is practically non-toxic following single oral administration. The key study on acute inhalation toxicity was carried out using Niacine. Niacine may be used in a read-across approach for Nicotinamide, as both compounds are convertible within the human body. The study was carried out according to OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class (ATC) Method). The LC50 for 4-hour exposure of Niacin obtained was greater than 3.8 mg/L air (chemically determined mean aerosol concentration), which was the highest achievable aerosol concentration. In the key dermal toxicity study in rats was carried out according to EU Method B.3 and OECD Guideline 402 (Acute Dermal Toxicity). In this limit test the LD50 for males/females was > 2000 mg/kg bw. In conclusion, the test item was considered practically non-toxic administered via the oral, inhalation or dermal route. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81331048-f0b1-402b-9a98-a23603b265f8/documents/IUC5-d48bc9d9-01de-42f7-bca3-aed8ff1851ce_e501f08f-62ac-42c3-b9cf-c9cbe1d7d2b0.html,,,,,, Nicotinamide,98-92-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81331048-f0b1-402b-9a98-a23603b265f8/documents/IUC5-d48bc9d9-01de-42f7-bca3-aed8ff1851ce_e501f08f-62ac-42c3-b9cf-c9cbe1d7d2b0.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Nicotinamide,98-92-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81331048-f0b1-402b-9a98-a23603b265f8/documents/IUC5-d48bc9d9-01de-42f7-bca3-aed8ff1851ce_e501f08f-62ac-42c3-b9cf-c9cbe1d7d2b0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Nicotinamide,98-92-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81331048-f0b1-402b-9a98-a23603b265f8/documents/IUC5-d48bc9d9-01de-42f7-bca3-aed8ff1851ce_e501f08f-62ac-42c3-b9cf-c9cbe1d7d2b0.html,,inhalation,LC50,"3,800 mg/m3",no adverse effect observed, Nitroethane,79-24-3,"OECD considered nitromethane, nitroethane and 1-nitropropane to be a category at SIAM. Therefore data from the analogue 1-nitropropane is used.Oral administration of the analogue, 1-Nitropropane, to rats for a period of twenty-eight consecutive days at dose levels of up to 100 mg active ingredient/kg/day resulted in toxicologically significant effects at 100 mg active ingredient/kg/day. No such effects were detected at 30 or 10 mg active ingredient/kg/day and, the ""No Observed Effect, Level "" (NOEL) is, therefore, considered to be 30 mg active ingredient/kg/day.Groups of male and female rats and mice were exposed to 0, 100, 350, or 1000 ppm (0, 0.3, 1.0 or 3.0 mg/L) of nitroethane for 6 hr/day, 5 days/wk for a total of 64-65 exposures with an interim sacrifice of rats and mice after 20-21 exposures. Parameters monitored were clinical observations, body weights, organ weights, hematologic characteristics including methemoglobin (MetHb) determination, clinical chemistries, urinalysis, gross pathology and histopathology. Minimal changes in MetHb, spleen and salivary glands were observed in rats exposed to 100 ppm. Mice exposed to 100 ppm nitroethane showed minimal changes in the nasal turbinates and transient (even after continued exposure) effects on salivary gland epithelium only. The 100 ppm nitroethane exposure concentration was judged to be a minimal effect level under the conditions of this study. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5aebd0f-c4ec-42b5-86e6-7084eb141c23/documents/IUC5-2704ba13-d7a0-485f-a6fc-d8cdb75fb9ad_5e47ec92-84e6-4cb8-b4f0-d3f798eb20de.html,,,,,, Nitroethane,79-24-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5aebd0f-c4ec-42b5-86e6-7084eb141c23/documents/IUC5-2704ba13-d7a0-485f-a6fc-d8cdb75fb9ad_5e47ec92-84e6-4cb8-b4f0-d3f798eb20de.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat Nitroethane,79-24-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5aebd0f-c4ec-42b5-86e6-7084eb141c23/documents/IUC5-2704ba13-d7a0-485f-a6fc-d8cdb75fb9ad_5e47ec92-84e6-4cb8-b4f0-d3f798eb20de.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,300 mg/m3,,rat Nitroethane,79-24-3," The acute oral LD50 in rabbits was slightly lower than for rats, 625 and >/= 1000 mg/kg, respectively. The dermal LD50 was >2000 mg/kg in rabbits. The acute inhalation LC50 in rats is considered to be 6025 ppm. . ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5aebd0f-c4ec-42b5-86e6-7084eb141c23/documents/IUC5-2c434396-60d3-4e3f-a9a6-bafbe1d23663_5e47ec92-84e6-4cb8-b4f0-d3f798eb20de.html,,,,,, Nitroethane,79-24-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5aebd0f-c4ec-42b5-86e6-7084eb141c23/documents/IUC5-2c434396-60d3-4e3f-a9a6-bafbe1d23663_5e47ec92-84e6-4cb8-b4f0-d3f798eb20de.html,,oral,LD50,"1,083 mg/kg bw",adverse effect observed, Nitroethane,79-24-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5aebd0f-c4ec-42b5-86e6-7084eb141c23/documents/IUC5-2c434396-60d3-4e3f-a9a6-bafbe1d23663_5e47ec92-84e6-4cb8-b4f0-d3f798eb20de.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Nitroethane,79-24-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5aebd0f-c4ec-42b5-86e6-7084eb141c23/documents/IUC5-2c434396-60d3-4e3f-a9a6-bafbe1d23663_5e47ec92-84e6-4cb8-b4f0-d3f798eb20de.html,,inhalation,LC50,"19,882 mg/m3",no adverse effect observed, Nitromethane,75-52-5,"The text of this endpoint summary has been lost by ECHA as part of IUCLID version update end May-2023. We have no control over ECHA’s potential restoring of the endpoint summaries they lost. On our side, we won’t rewrite the lost endpoint summaries since no CSR is required for this substance’s registration tonnage band. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3a9b7e8-fdc0-4300-b658-d3a49b0a8747/documents/IUC5-f37858be-697d-4db5-a7e4-b7fc2bafc03f_0e431461-1013-4c58-8614-e65f2271e4ff.html,,,,,, Nitromethane,75-52-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3a9b7e8-fdc0-4300-b658-d3a49b0a8747/documents/IUC5-f37858be-697d-4db5-a7e4-b7fc2bafc03f_0e431461-1013-4c58-8614-e65f2271e4ff.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat Nitromethane,75-52-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3a9b7e8-fdc0-4300-b658-d3a49b0a8747/documents/IUC5-f37858be-697d-4db5-a7e4-b7fc2bafc03f_0e431461-1013-4c58-8614-e65f2271e4ff.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,936.2 mg/m3,,rat Nitromethane,75-52-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3a9b7e8-fdc0-4300-b658-d3a49b0a8747/documents/IUC5-f37858be-697d-4db5-a7e4-b7fc2bafc03f_0e431461-1013-4c58-8614-e65f2271e4ff.html,Repeated dose toxicity – local effects,inhalation,NOAEC,188 mg/m3,adverse effect observed,rat Nitromethane,75-52-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3a9b7e8-fdc0-4300-b658-d3a49b0a8747/documents/IUC5-0b7853d3-14e5-4958-aadb-b225307a58c5_0e431461-1013-4c58-8614-e65f2271e4ff.html,,oral,LD50,"1,478 mg/kg bw",adverse effect observed, Nitromethane,75-52-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3a9b7e8-fdc0-4300-b658-d3a49b0a8747/documents/IUC5-0b7853d3-14e5-4958-aadb-b225307a58c5_0e431461-1013-4c58-8614-e65f2271e4ff.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Nitromethane,75-52-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3a9b7e8-fdc0-4300-b658-d3a49b0a8747/documents/IUC5-0b7853d3-14e5-4958-aadb-b225307a58c5_0e431461-1013-4c58-8614-e65f2271e4ff.html,,inhalation,LC50,"12,000 mg/m3",adverse effect observed, 2-nitrophenol,88-75-5,"In the study reported by the Commission of the European Communities DG XI (1993) the oral repeated dose toxicity (28 days, subacute, Koerdel et al. 1981) in the rat was determined similar to the OECD guideline 407. Owing to insufficient documentation and the fact that there were minor effects shown by all exposed animals, a reliable NO(A)EL cannot be deduced.In the study reported by the International Programme on Chemical Safety (IPCS) the inhalative repeated dose toxicity (28 days, subacute, Hazleton 1984) in the rat was determined. A LOAEL was set at 0.06 mg/l air, based on the fact that squamous metaplasia of the epithelium lining the maxillo-turbinates and naso-turbinates was observed in all animals of the 0.06 mg/l air dose group. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10bb1389-532a-4b56-aa68-e0d549e5a714/documents/IUC5-a2e1a148-c574-4c9f-ba40-2a640e1fee8a_873ac933-28ec-48b4-8c81-be83d3b4a85a.html,,,,,, 2-nitrophenol,88-75-5,"The substance was found to cause methaemoglobin formation of > 40% at doses of 100 and 250 mg/kg bw in cats. Therefore, the LD50 values for rats underestimate the hazard for human health and the substance is classified as harmful. Oral: LD50 > 3200 mg/kg bw (BASF: XIX/429, 1970), rat. Mortality occurred at 3200 mg/kg bw, but not at 1600 mg/kg bw.Inhalation: LC0 0.22 mg/l No mortalities occurred. (BASF: XIX/429, 1970), inhalation hazard test, ratDermal: LD50 > 7940 mg/kg bw (ECB-IUCLID, 2000), rabbit; LD 50 > 5000 mg/kg bw (International Programme on Chemical Safety (IPCS), ratMethaemoglobinaemia in the cat: In animals treated once with 250 and 100 mg/kg bw, respectively, per gavage, formation of methaemoglobin was observed (BASF XIX/429, 1970). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10bb1389-532a-4b56-aa68-e0d549e5a714/documents/IUC5-c7008e44-6aec-4c48-8b06-1a7b2d5e89d3_873ac933-28ec-48b4-8c81-be83d3b4a85a.html,,,,,, 4-nitrophenol,100-02-7,"Data on the acute toxicity of 4-nitrophenol (oral, dermal and inhalation route) has been reviewed in several reports; the information of which is provided under ""discussion"".According to regulation (EC) No 1272/2008 on classification. labelling and packaging of substances and mixtures, p-nitrophenol (4-nitrophenol) is officially classified as acute oral, dermal and inhalation toxicity category 4 (H302, H312 and H332). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07baacd5-9f20-411b-9fe0-578d0661c742/documents/IUC5-bc4a6064-f1df-4e99-b647-fd9f386b6bd4_8d5dd11d-7c72-407d-9e38-aec9624da038.html,,,,,, 4-nitrophenol,100-02-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07baacd5-9f20-411b-9fe0-578d0661c742/documents/IUC5-bc4a6064-f1df-4e99-b647-fd9f386b6bd4_8d5dd11d-7c72-407d-9e38-aec9624da038.html,,oral,LD50,200 mg/kg bw,, 4-nitrophenol,100-02-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07baacd5-9f20-411b-9fe0-578d0661c742/documents/IUC5-bc4a6064-f1df-4e99-b647-fd9f386b6bd4_8d5dd11d-7c72-407d-9e38-aec9624da038.html,,dermal,LD50,"1,000 mg/kg bw",, 4-nitrophenol,100-02-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07baacd5-9f20-411b-9fe0-578d0661c742/documents/IUC5-bc4a6064-f1df-4e99-b647-fd9f386b6bd4_8d5dd11d-7c72-407d-9e38-aec9624da038.html,,inhalation,,0.005 mg/m3,, Dinitrogen oxide,10024-97-2,"No repeated dose toxicity data are available for oral and dermal exposure. One reliable study is available that assesses the repeated dose toxicity after inhalation exposure (comparable to OECD guideline 413) in mice. The NOAEL was concluded to be 50,000 ppm.    ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e255af1-3d8b-4825-9f50-f9af5bfd518e/documents/IUC5-427df211-0b63-46f2-83c7-7c913994c853_de96efb4-3bad-465f-8bea-08615673f9df.html,,,,,, Dinitrogen oxide,10024-97-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e255af1-3d8b-4825-9f50-f9af5bfd518e/documents/IUC5-427df211-0b63-46f2-83c7-7c913994c853_de96efb4-3bad-465f-8bea-08615673f9df.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"91,500 mg/m3",,mouse Dinitrogen oxide,10024-97-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e255af1-3d8b-4825-9f50-f9af5bfd518e/documents/IUC5-427df211-0b63-46f2-83c7-7c913994c853_de96efb4-3bad-465f-8bea-08615673f9df.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"50,000 ",, Dinitrogen oxide,10024-97-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e255af1-3d8b-4825-9f50-f9af5bfd518e/documents/IUC5-427df211-0b63-46f2-83c7-7c913994c853_de96efb4-3bad-465f-8bea-08615673f9df.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"500,000 ",no adverse effect observed, Dinitrogen oxide,10024-97-2,"As the nitrous oxide is a gas, no  studies on oral and dermal acute toxicity were conducted.In a 90-day inhalation study Swiss Webster mice (15/sex/gp) were exposed to N2O via whole body inhalation at concentrations of 0, 5000, 50000 or 500000 ppm [0, 0.5, 5, 50%] for 4/h/d, 5d/wk over 14 wks. As no mortality was observed, it is reasonable to conclude that the acute LD50 for inhalation expsoure exceeds 500000 ppm. N2O is an approved medical product in accordance with applicable medical regulations. It has been used in clinical anaesthetic practice for more than 150 yr, and its longevity should be considered within the context of all the major advances in anaesthetic practice over that time. No acute toxicity effects to humans have been reported throughout its use (Sanders et al (2008) Biologic effects of Nitrous Oxide. Anesthesiology 109: 707-722).  ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e255af1-3d8b-4825-9f50-f9af5bfd518e/documents/IUC5-41d96bcc-51fe-4115-82c4-b056853a2389_de96efb4-3bad-465f-8bea-08615673f9df.html,,,,,, Dinitrogen oxide,10024-97-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e255af1-3d8b-4825-9f50-f9af5bfd518e/documents/IUC5-41d96bcc-51fe-4115-82c4-b056853a2389_de96efb4-3bad-465f-8bea-08615673f9df.html,,inhalation,LC50,"> 900,061 mg/m3",no adverse effect observed, Nonan-2-one,821-55-6," Repeated dose toxicity- Oral: In a repeated dose toxicity study, CD, COBS male rats treated with Methyl heptyl ketone ( IUPAC name: nonan-2-one) in the concentration of 0, 1000, 2000 and 4000 mg/kg/day orally by gavage for 3 weeks. Following two to four doses of 4000 mg/kg/day animals withsevear depressionwere died and significant decrease in body weight gain were observed in treated rats as compared to control. Slitdecrease in body weight gain in in 2000 mg/kg/day and significant increase in absolute and relative liver and relative kidney weight were observed in 1000 and 2000 mg/kg/day treated rats as compared to control. Increased mean absolute kidney weights were considered to be not statistically significantfor 1000 mg/kg/day dose group.In addition, Vascular congestion and hemorrhage in major organ andModerate hepatocyte hypertrophy with minimal focal hepatic necrosis and enlarged hepatocytes impinged on sinusoidal spaces reducing their volume and severe central nervous system depression and consequent failure to maintain normal pulmonary ventilation and perfusion were observed at 4000 mg/kg/day treated ratsandminorto moderate hepatocyte hypertrophy were observed at 2000 mg/kg/day treated rats as compared to control. Therefore, No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg/day when CD, COBS male rats treated with Methyl heptyl ketone. Repeated dose toxicity: Inhalation In Combined repeated dose repro-devp. Screen test, Sprague Dawley male and female rats were exposed to 2 -Nonanone by inhalation in the concentration of 0, 80, 400 and 1000 ppm (0, 80, 400 or 1000 mg/L). Actual exposure concentrations is 0, 78.6, 405.8 or 1022.6 ppm (0, 78.6, 405.8 or 1022.6 mg/L) for 6 hours/day, 7 days/week for 50 days. No effect on survival, body weight and weight gain were observed in treated rats as compared to control. Minimal reductions in activity level were observed in 40 and 100 mg/kg/day dose group andreduction in food consumption during days 0 -7 in 100 mg/kg/day dose group were observed as compared to control. In addition, no effects were observed on organ weight, gross pathology, sperm parameter and histopathology of treated rats as compared to control. Therefore, the No Observed Adverse effect concentration (NOAEC) was considered to be 80 ppm (80 mg/L) (actual dose 78.6 mg/L) when Sprague-Dawley male and female rats treated with 2-Nonanone ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df35aac4-987c-4aa7-a4c1-302c5b622744/documents/da8bf119-920f-4e82-832e-17923e6236c3_11c9a71e-3dba-437b-a15e-d3ffbe49d5e0.html,,,,,, Nonan-2-one,821-55-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df35aac4-987c-4aa7-a4c1-302c5b622744/documents/da8bf119-920f-4e82-832e-17923e6236c3_11c9a71e-3dba-437b-a15e-d3ffbe49d5e0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Nonan-2-one,821-55-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df35aac4-987c-4aa7-a4c1-302c5b622744/documents/da8bf119-920f-4e82-832e-17923e6236c3_11c9a71e-3dba-437b-a15e-d3ffbe49d5e0.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,80 mg/m3,,rat Nonan-2-one,821-55-6, Acute oral toxicity: LD50 was considered t be > 5000 mg/kg bw when rats were treated with nonan-2-one orally. Acute dermal toxicity: LD50 was considered t be > 5000 mg/kg bw when rabbits were treated with nonan-2-one by dermal application. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df35aac4-987c-4aa7-a4c1-302c5b622744/documents/6cbaf226-8e75-495f-bd52-7d34297a0211_11c9a71e-3dba-437b-a15e-d3ffbe49d5e0.html,,,,,, Nonan-2-one,821-55-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df35aac4-987c-4aa7-a4c1-302c5b622744/documents/6cbaf226-8e75-495f-bd52-7d34297a0211_11c9a71e-3dba-437b-a15e-d3ffbe49d5e0.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Nonan-2-one,821-55-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df35aac4-987c-4aa7-a4c1-302c5b622744/documents/6cbaf226-8e75-495f-bd52-7d34297a0211_11c9a71e-3dba-437b-a15e-d3ffbe49d5e0.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Nonanal,124-19-6,A study on the analogue substance was assessed for repeated dose oral toxicity according to OECD 408. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af0f639f-66b9-45f7-98d1-18bcb9629155/documents/IUC5-673f90ae-07c1-438c-8c17-e0f3ea16a41e_5f0fed9d-c947-49fa-b17f-cc7c66aeeceb.html,,,,,, Nonanal,124-19-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af0f639f-66b9-45f7-98d1-18bcb9629155/documents/IUC5-673f90ae-07c1-438c-8c17-e0f3ea16a41e_5f0fed9d-c947-49fa-b17f-cc7c66aeeceb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,409.7 mg/kg bw/day",,rat Nonanal,124-19-6,"Acute oral toxicity weight of evidence approach was used. One study performed on the target substance gave an LD50 of 5000 mg/kg bw. Further studies on the analogue substance, decanal, gave an LD50 >33320 mg/kg bw in rats and 41750 mg/kg bw in mice.Acute dermal toxicity weight of evidence approach was used. One study performed on the target substance gave an LD50 of 5000 mg/kg bw. Further studies on the analogue substances Octanal and Decanal gave LD50s of 6.85 mL/kg bw and 5.04 mL/kg bw respectively. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af0f639f-66b9-45f7-98d1-18bcb9629155/documents/IUC5-d199e326-a6c1-4ce4-8fdd-1e13225c4e62_5f0fed9d-c947-49fa-b17f-cc7c66aeeceb.html,,,,,, Nonanal,124-19-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af0f639f-66b9-45f7-98d1-18bcb9629155/documents/IUC5-d199e326-a6c1-4ce4-8fdd-1e13225c4e62_5f0fed9d-c947-49fa-b17f-cc7c66aeeceb.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Nonanal,124-19-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af0f639f-66b9-45f7-98d1-18bcb9629155/documents/IUC5-d199e326-a6c1-4ce4-8fdd-1e13225c4e62_5f0fed9d-c947-49fa-b17f-cc7c66aeeceb.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Nonane,111-84-2,Repeated Dose Oral 90d - NOAEL = 100 mg/kg bw/day for female rats (OECD 408)   Repeated Dose Oral 90d - NOAEL = 100 mg/kg bw/day for male mice (OECD 408)     Repeated Dose Inhalation 90d – NOAEC ≥ 24300 mg/m3 for rats (similar to OECD TG 413) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11534822-84de-4318-8f21-e3028c1bc72e/documents/186bd85e-aeee-42af-bc3c-96b4cb0c10a2_47d8c15d-eb54-4d5e-b0a8-a1c92343fb0e.html,,,,,, Nonane,111-84-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11534822-84de-4318-8f21-e3028c1bc72e/documents/186bd85e-aeee-42af-bc3c-96b4cb0c10a2_47d8c15d-eb54-4d5e-b0a8-a1c92343fb0e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,other:female rats and male mice Nonane,111-84-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11534822-84de-4318-8f21-e3028c1bc72e/documents/186bd85e-aeee-42af-bc3c-96b4cb0c10a2_47d8c15d-eb54-4d5e-b0a8-a1c92343fb0e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"24,300 mg/m3",,rat Nonane,111-84-2,Oral LD50 (rat) > 5000 mg/kg bw   Inhalation LC50 (rat) = 17000 mg/m3     Dermal LD50 (rabbit) > 2000 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11534822-84de-4318-8f21-e3028c1bc72e/documents/4b5fe55b-ed30-4177-bb5d-229396cb07c5_47d8c15d-eb54-4d5e-b0a8-a1c92343fb0e.html,,,,,, Nonane,111-84-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11534822-84de-4318-8f21-e3028c1bc72e/documents/4b5fe55b-ed30-4177-bb5d-229396cb07c5_47d8c15d-eb54-4d5e-b0a8-a1c92343fb0e.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Nonane,111-84-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11534822-84de-4318-8f21-e3028c1bc72e/documents/4b5fe55b-ed30-4177-bb5d-229396cb07c5_47d8c15d-eb54-4d5e-b0a8-a1c92343fb0e.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, Nonane,111-84-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11534822-84de-4318-8f21-e3028c1bc72e/documents/4b5fe55b-ed30-4177-bb5d-229396cb07c5_47d8c15d-eb54-4d5e-b0a8-a1c92343fb0e.html,,inhalation,LC50,"17,000 mg/m3",no adverse effect observed, "D-Glucitol, 1-deoxy-1-[methyl(1-oxononyl)amino]-",85261-19-4," The test item was tested for its acute oral toxicity potential. In total six healthy female Sprague Dawley rats were dosed orally with the test item at 2000 mg/kg. The rats were observed at 15 minutes, 1, 2 and 4 hours postdose and once daily for 14 days for toxicity and pharmacological effects, and twice daily for mortality. All six female rats survived following the single 2000 mg/kg oral dose. No test item realated and toxicological relevant effects were observed after administration of the test item over the observation period of 14 days. The gross necropsy revealed no observable abnormalities. Based on these results the oral LD50 of the test item is greater than 2000 mg/kg of body weight in females rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e13ad01-7eea-43ac-bdb1-4109aace7085/documents/f4c5795b-25ed-434e-8c9d-b1694a85cf84_7bb1bb34-0d4d-4646-a4c2-1c85e68e0533.html,,,,,, "D-Glucitol, 1-deoxy-1-[methyl(1-oxononyl)amino]-",85261-19-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e13ad01-7eea-43ac-bdb1-4109aace7085/documents/f4c5795b-25ed-434e-8c9d-b1694a85cf84_7bb1bb34-0d4d-4646-a4c2-1c85e68e0533.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-Nonylphenol, ethoxylated",26027-38-3," Acute oral toxicity: In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the acute oral toxicity was estimated for 4-Nonylphenol, ethoxylated. The LD50 was estimated to be 1932.07 mg/kg bw when rats were orally exposed with 4-Nonylphenol, ethoxylated. Based on the value, 4-Nonylphenol, ethoxylated was considered to be toxic to rats and can be considered to be classified in category 4 as per the CLP regulations. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b97c3833-aa8e-464c-95f8-e9108c982369/documents/378c6ded-44a2-4688-ab55-3cbf111e7e00_7a818be6-d995-4735-9434-6c43bcb5f08d.html,,,,,, "4-Nonylphenol, ethoxylated",26027-38-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b97c3833-aa8e-464c-95f8-e9108c982369/documents/378c6ded-44a2-4688-ab55-3cbf111e7e00_7a818be6-d995-4735-9434-6c43bcb5f08d.html,,oral,LD50,"1,932.07 mg/kg bw",adverse effect observed, Nonan-1-ol,143-08-8," A read across from a reliable 13 week dietary study in rats using hexan-1-ol reported a NOAEL of 1127 mg/kg (Scientific Associates Inc., 1966). The results of this key study are supported by a reliable three week feeding study in rats using hexan-1-ol which reported a NOAEL of approximately 1000 mg/kg bw/day (Moody 1978 ). In addition a 90 day repeated dose dermal study (Wil Research 1995) in rats where a multi-constituent solution containing circa 50% decan-1-ol and circa 45% octan-1-ol (semi-occluded conditions) reported no systemic effects at the highest dose tested. The study did however give rise to marked dermal irritative effect. It is however important to take in to account the different test protocol that was used, that is a 90 day repeated dose dermal study (6 hours/day for 5 days/week) compared to a standard 4 hour dermal irritation study and the different species (rats instead of rabbit) and test duration (90 days vs. 4 hours). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c05568c4-603e-4b14-b548-8ee7a10034dc/documents/5e83c4f0-9c86-4a69-86e0-529032724174_6317898f-2174-4b55-9996-a42ceb4fef1e.html,,,,,, Nonan-1-ol,143-08-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c05568c4-603e-4b14-b548-8ee7a10034dc/documents/5e83c4f0-9c86-4a69-86e0-529032724174_6317898f-2174-4b55-9996-a42ceb4fef1e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,127 mg/kg bw/day",,rat Nonan-1-ol,143-08-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c05568c4-603e-4b14-b548-8ee7a10034dc/documents/5e83c4f0-9c86-4a69-86e0-529032724174_6317898f-2174-4b55-9996-a42ceb4fef1e.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat Nonan-1-ol,143-08-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c05568c4-603e-4b14-b548-8ee7a10034dc/documents/5e83c4f0-9c86-4a69-86e0-529032724174_6317898f-2174-4b55-9996-a42ceb4fef1e.html,Repeated dose toxicity – local effects,dermal,NOAEL,2.8 mg/cm2,adverse effect observed,rat Nonan-1-ol,143-08-8," All the acute toxicity key studies are read across from decanol (112-30-1). The acute oral key study in rat reports an LD50 value of >5000 mg/kg (Eurofins 2009; rel 1). The acute inhalation key study in rat exposed the animals to atmosphere generated as mist for 1 hour, with a result of LC50 >71mg/L (Scientific Associates 1977; rel 2). The acute dermal key study in rat reports an LD50 value of >5000 mg/kg (Eurofins 2009; rel 1). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c05568c4-603e-4b14-b548-8ee7a10034dc/documents/02e54951-8cd7-4c70-908d-e8b8a8c11634_6317898f-2174-4b55-9996-a42ceb4fef1e.html,,,,,, Nonan-1-ol,143-08-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c05568c4-603e-4b14-b548-8ee7a10034dc/documents/02e54951-8cd7-4c70-908d-e8b8a8c11634_6317898f-2174-4b55-9996-a42ceb4fef1e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Nonan-1-ol,143-08-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c05568c4-603e-4b14-b548-8ee7a10034dc/documents/02e54951-8cd7-4c70-908d-e8b8a8c11634_6317898f-2174-4b55-9996-a42ceb4fef1e.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Nonan-1-ol,143-08-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c05568c4-603e-4b14-b548-8ee7a10034dc/documents/02e54951-8cd7-4c70-908d-e8b8a8c11634_6317898f-2174-4b55-9996-a42ceb4fef1e.html,,inhalation,LC50,"71,000 mg/m3",no adverse effect observed, "[4R-(4α,4aα,6β)]-4,4a,5,6,7,8-hexahydro-4,4a-dimethyl-6-(1-methylvinyl)naphthalen-2(3H)-one",4674-50-4,"Acute oral toxicity (Moreno 1977, RIFM 1695): LD50 > 5000 mg/kg  Acute dermal toxicity (Moreno 1977, RIFM 1695): LD50 > 5000 mg/kg  ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef5fe727-dc77-4dc0-9a1e-146754aeb278/documents/a465ccb3-b5ea-432d-8b49-28226af8047c_2ba60687-11cf-448c-b45c-c57c6e09bace.html,,,,,, "[4R-(4α,4aα,6β)]-4,4a,5,6,7,8-hexahydro-4,4a-dimethyl-6-(1-methylvinyl)naphthalen-2(3H)-one",4674-50-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef5fe727-dc77-4dc0-9a1e-146754aeb278/documents/a465ccb3-b5ea-432d-8b49-28226af8047c_2ba60687-11cf-448c-b45c-c57c6e09bace.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "[4R-(4α,4aα,6β)]-4,4a,5,6,7,8-hexahydro-4,4a-dimethyl-6-(1-methylvinyl)naphthalen-2(3H)-one",4674-50-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef5fe727-dc77-4dc0-9a1e-146754aeb278/documents/a465ccb3-b5ea-432d-8b49-28226af8047c_2ba60687-11cf-448c-b45c-c57c6e09bace.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, 2-aminophenol,95-55-6," Two subacute oral toxicity studies in rats were performed with o-aminophenol. In study 1 with treatment over 30 days at daily doses 0, 20, 80, 320 mg/kg bw, none of the three tested doses could be considered as a NOAEL. In study 2 with doses of 0, 2. 5 and 15 mg/kg bw/d, a NOAEL of 5 mg/kg bw/d was derived based on the thyroid weight changes observed. Both subchronic toxicity studies are considered to be inconclusive. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cee6afec-8448-41bb-9e80-7a987d5919a7/documents/570c1e09-d857-41a7-a5ee-0408e666cb8e_1f2e95ce-9dd9-4dfa-add5-d051911f013c.html,,,,,, 2-aminophenol,95-55-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cee6afec-8448-41bb-9e80-7a987d5919a7/documents/570c1e09-d857-41a7-a5ee-0408e666cb8e_1f2e95ce-9dd9-4dfa-add5-d051911f013c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat o-cresol,95-48-7,"Subchronic inhalational exposure (4 months) of rats to o-cresol causes reduced locomotor activity, inflammation of respiratory tissues and changes in the liver. No NOAEL could be determined for this route. Oral exposure of up to 13 weeks of mice and rats resulted in mortality, tremors, reduced body weights, hematologic effects and increase in organ weights. An overall subchronic NOAEL of 50 mg/kg bw/day can be derived (OECD SIDS for o-Cresol, CAS No: 95-48-7, UNEP publication). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f7c7544-3e6d-4d19-8c86-c8254121da44/documents/IUC5-885bf52c-5523-4a7d-b9f4-abaf2a005caa_d7a88f06-f1ac-4476-b661-c2c4bfadef8a.html,,,,,, o-cresol,95-48-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f7c7544-3e6d-4d19-8c86-c8254121da44/documents/IUC5-885bf52c-5523-4a7d-b9f4-abaf2a005caa_d7a88f06-f1ac-4476-b661-c2c4bfadef8a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat o-cresol,95-48-7,There is no study according to the current guideline but the given information is sufficient to evaluate this endpoint.The oral LD50 of undiluted o-cresol in rats is 121 mg/kg bw and the dermal LD50 for rabbits is 1380 mg/kg bw (Ind Bio-test Lab Inc 1969). The data base on acute inhalation toxicity of o-cresol is very limited and does not allow final conclusion. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f7c7544-3e6d-4d19-8c86-c8254121da44/documents/IUC5-7117ec62-129f-4296-95d5-a73bd216e734_d7a88f06-f1ac-4476-b661-c2c4bfadef8a.html,,,,,, o-cresol,95-48-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f7c7544-3e6d-4d19-8c86-c8254121da44/documents/IUC5-7117ec62-129f-4296-95d5-a73bd216e734_d7a88f06-f1ac-4476-b661-c2c4bfadef8a.html,,oral,LD50,121 mg/kg bw,adverse effect observed, o-cresol,95-48-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f7c7544-3e6d-4d19-8c86-c8254121da44/documents/IUC5-7117ec62-129f-4296-95d5-a73bd216e734_d7a88f06-f1ac-4476-b661-c2c4bfadef8a.html,,dermal,LD50,"1,380 mg/kg bw",adverse effect observed, O-phosphoserine,407-41-0," Based on the pH of 1.7 of the test substance (see reference 4.20-1), the test substance is classified as corrosive to the skin (UN GHS Category 1, H314). According to REACH Annex VII, 8.5 Column 2, no test for acute oral toxcicity is necessary. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b1b8be1-0aa7-40c7-afb5-3049ebeae879/documents/1c9c6e39-3bc8-41e5-b762-f85f7d5480e2_2cd779d2-a7c9-47e1-84df-224ca7584344.html,,,,,, 1-o-tolylbiguanide,93-69-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c33fd29-c32e-407d-ba27-3fee87226c35/documents/IUC5-22096103-790d-4971-9f79-e3a79300910c_8a19aac9-deef-41dc-89a7-b22a0d1b8c7d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 1-o-tolylbiguanide,93-69-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c33fd29-c32e-407d-ba27-3fee87226c35/documents/IUC5-b84a2c16-573f-4a4a-950d-b117940c1e9d_8a19aac9-deef-41dc-89a7-b22a0d1b8c7d.html,,oral,LD50,"2,390 mg/kg bw",adverse effect observed, 1-o-tolylbiguanide,93-69-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c33fd29-c32e-407d-ba27-3fee87226c35/documents/IUC5-b84a2c16-573f-4a4a-950d-b117940c1e9d_8a19aac9-deef-41dc-89a7-b22a0d1b8c7d.html,,dermal,LD50,"3,170 mg/kg bw",adverse effect observed, "3,7-dimethylocta-1,3,6-triene",13877-91-3,NOAEL (OECD TG 422): 500 mg/kg bw ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10b81ae8-c345-4a08-b7c8-68940ffc9738/documents/50797952-e37b-4aab-806c-a089079df557_b568c1a9-99a1-4ecc-b350-bec0538f1443.html,,,,,, "3,7-dimethylocta-1,3,6-triene",13877-91-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10b81ae8-c345-4a08-b7c8-68940ffc9738/documents/50797952-e37b-4aab-806c-a089079df557_b568c1a9-99a1-4ecc-b350-bec0538f1443.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,> 500 mg/kg bw/day,,rat "3,7-dimethylocta-1,3,6-triene",13877-91-3,Acute oral toxicity of Ocimene: a study similar to OECD TG 401 was performed: LD50 = ca. 5000 mg/kg Acute inhalation toxicity of Ocimene: route-to-route extrapolation from the acute oral toxicity study: LD50 = 2600 mg/m3 Acute dermal toxicity of Ocimene: a study similar to OECD TG 402 was performed: LD50 > 5000 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10b81ae8-c345-4a08-b7c8-68940ffc9738/documents/40f57da9-878d-495b-9e8a-dbf189f27e5d_b568c1a9-99a1-4ecc-b350-bec0538f1443.html,,,,,, "3,7-dimethylocta-1,3,6-triene",13877-91-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10b81ae8-c345-4a08-b7c8-68940ffc9738/documents/40f57da9-878d-495b-9e8a-dbf189f27e5d_b568c1a9-99a1-4ecc-b350-bec0538f1443.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "3,7-dimethylocta-1,3,6-triene",13877-91-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10b81ae8-c345-4a08-b7c8-68940ffc9738/documents/40f57da9-878d-495b-9e8a-dbf189f27e5d_b568c1a9-99a1-4ecc-b350-bec0538f1443.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "Ocimum basilicum, ext.",84775-71-3, Acute oral toxicity using read across from Linalool (tested in a study similar to OECD TG 401): LD50 = 2790 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ae14f18-96cb-4e34-8ae7-d21f7210e7e1/documents/50f7206d-1a90-4abe-a4be-594ba07530b9_c114fef7-fe11-45fa-a024-3a42e0067ef4.html,,,,,, Octadecane,593-45-3, Repeated Dose Oral 90d - NOAEL ≥ 500 mg/kg bw/day for rats (OECD 408); BMDL = 1857 mg/Kg bw/day. Repeated Dose Inhalation 90d – NOAEC ≥ 6000 mg/m3 for rats (similar to OECD TG 413) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a167cae-1f5c-46f9-818c-fe3df2fc4027/documents/52369b59-4f5e-4530-9b13-20d29954db9b_7f5f2900-c5d1-48a0-b5cc-1a2912f075c8.html,,,,,, Octadecane,593-45-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a167cae-1f5c-46f9-818c-fe3df2fc4027/documents/52369b59-4f5e-4530-9b13-20d29954db9b_7f5f2900-c5d1-48a0-b5cc-1a2912f075c8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Octadecane,593-45-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a167cae-1f5c-46f9-818c-fe3df2fc4027/documents/52369b59-4f5e-4530-9b13-20d29954db9b_7f5f2900-c5d1-48a0-b5cc-1a2912f075c8.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"6,000 mg/m3",,rat Octadecane,593-45-3, Oral LD50 (rat) > 5000 mg/Kg bw   Inhalation LC50 (rat) >5991 mg/m³   Dermal LD50 (rabbit) > 2000 mg/Kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a167cae-1f5c-46f9-818c-fe3df2fc4027/documents/59090fd2-71d2-4183-9d81-73a3858e82e5_7f5f2900-c5d1-48a0-b5cc-1a2912f075c8.html,,,,,, Octadecane,593-45-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a167cae-1f5c-46f9-818c-fe3df2fc4027/documents/59090fd2-71d2-4183-9d81-73a3858e82e5_7f5f2900-c5d1-48a0-b5cc-1a2912f075c8.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Octadecane,593-45-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a167cae-1f5c-46f9-818c-fe3df2fc4027/documents/59090fd2-71d2-4183-9d81-73a3858e82e5_7f5f2900-c5d1-48a0-b5cc-1a2912f075c8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Octadecane,593-45-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a167cae-1f5c-46f9-818c-fe3df2fc4027/documents/59090fd2-71d2-4183-9d81-73a3858e82e5_7f5f2900-c5d1-48a0-b5cc-1a2912f075c8.html,,inhalation,LC50,"5,991 mg/m3",no adverse effect observed, Octadecene,27070-58-2," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a5b6f01-7d4d-4123-ba4a-01fb8e7cd9f6/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_20767f33-d109-465c-b0bd-0a055f5cc3e8.html,,,,,, Octadecene,27070-58-2,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a5b6f01-7d4d-4123-ba4a-01fb8e7cd9f6/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_20767f33-d109-465c-b0bd-0a055f5cc3e8.html,,,,,, "Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate",2082-79-3,"The test article was administered to dogs in a daily diet over a period of 90 days (CIBA-GEIGY 1981). Due to the non-reversible increase in liver weight at higher dose levels, the NOAEL is considered to be 34 mg/kg bw/day. In a chronic feeding study with rats, the test article caused increase in liver and thyroid weight (Ciba-Geigy 1974a), Due to these results, the NOAEL is considered to be 64 mg/kg bw/day in males and 81 mg/kg bw in females, respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb0a221c-7a15-466a-bb85-9b66663c1ef9/documents/IUC5-9d155b43-4244-49ee-9007-442610159362_650fbe5f-ab45-451e-906e-369bf609976b.html,,,,,, "Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate",2082-79-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb0a221c-7a15-466a-bb85-9b66663c1ef9/documents/IUC5-9d155b43-4244-49ee-9007-442610159362_650fbe5f-ab45-451e-906e-369bf609976b.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,543 mg/m3,,rat "Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate",2082-79-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb0a221c-7a15-466a-bb85-9b66663c1ef9/documents/IUC5-9d155b43-4244-49ee-9007-442610159362_650fbe5f-ab45-451e-906e-369bf609976b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,34 mg/kg bw/day,,dog "Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate",2082-79-3,"LD50 Oral gavage (rat) > 5000 mg/kg bw (similar to OECD 401, Ciba-Geigy 1981)LD50 Inhalation (rat) > 1.81 mg/L (aerosol with 45% particles of less than 3 µm in diameter, similar to OECD 403, Ciba-Geigy 1978)LD50 Dermal (rat) > 2000 mg/kg bw (OECD 402, GLP, Ciba-Geigy 1992) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb0a221c-7a15-466a-bb85-9b66663c1ef9/documents/IUC5-cef3cd85-6500-464d-a4c1-a98fb5502681_650fbe5f-ab45-451e-906e-369bf609976b.html,,,,,, "Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate",2082-79-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb0a221c-7a15-466a-bb85-9b66663c1ef9/documents/IUC5-cef3cd85-6500-464d-a4c1-a98fb5502681_650fbe5f-ab45-451e-906e-369bf609976b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate",2082-79-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb0a221c-7a15-466a-bb85-9b66663c1ef9/documents/IUC5-cef3cd85-6500-464d-a4c1-a98fb5502681_650fbe5f-ab45-451e-906e-369bf609976b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate",2082-79-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb0a221c-7a15-466a-bb85-9b66663c1ef9/documents/IUC5-cef3cd85-6500-464d-a4c1-a98fb5502681_650fbe5f-ab45-451e-906e-369bf609976b.html,,inhalation,LC50,"1,800 mg/m3",no adverse effect observed, "2,2,3,3,4,4,5,5-octafluoropentyl methacrylate",355-93-1," The test article was well tolerated following 7-day oral gavage in male and female rats at 100 and 300 mg/kg/day. The no-observed-adverse-effect level (NOAEL) for nose-only inhalation exposure of the test substance to rats for 5 consecutive days was 168 ppm, the highest exposure concentration tested. No adverse effects were noted following repeated dermal exposure for 28 -days at the dose level of 1,300 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14e6ac41-14c3-4682-b3bb-aebf51dad9e1/documents/252e82a9-b30b-4231-85a9-e9bb0154a910_52bb7e8e-2c0e-4edc-b62f-98fbc25027db.html,,,,,, "2,2,3,3,4,4,5,5-octafluoropentyl methacrylate",355-93-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14e6ac41-14c3-4682-b3bb-aebf51dad9e1/documents/252e82a9-b30b-4231-85a9-e9bb0154a910_52bb7e8e-2c0e-4edc-b62f-98fbc25027db.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2,2,3,3,4,4,5,5-octafluoropentyl methacrylate",355-93-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14e6ac41-14c3-4682-b3bb-aebf51dad9e1/documents/252e82a9-b30b-4231-85a9-e9bb0154a910_52bb7e8e-2c0e-4edc-b62f-98fbc25027db.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,300 mg/kg bw/day",,rat "2,2,3,3,4,4,5,5-octafluoropentyl methacrylate",355-93-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14e6ac41-14c3-4682-b3bb-aebf51dad9e1/documents/252e82a9-b30b-4231-85a9-e9bb0154a910_52bb7e8e-2c0e-4edc-b62f-98fbc25027db.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"2,100 mg/m3",,rat "2,2,3,3,4,4,5,5-octafluoropentyl methacrylate",355-93-1, The acute oral LD50 of the substance is greater than 2000 mg/kg bw. The NOAEL for nose-only vapour inhalation exposure of the test substance to rats for 5 consecutive days was 168 ppm. Testing by the dermal route does not need to be conducted as the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects after dermal exposure are predicted. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14e6ac41-14c3-4682-b3bb-aebf51dad9e1/documents/b1730cb6-18af-4065-84ee-29e6521817e1_52bb7e8e-2c0e-4edc-b62f-98fbc25027db.html,,,,,, "2,2,3,3,4,4,5,5-octafluoropentyl methacrylate",355-93-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14e6ac41-14c3-4682-b3bb-aebf51dad9e1/documents/b1730cb6-18af-4065-84ee-29e6521817e1_52bb7e8e-2c0e-4edc-b62f-98fbc25027db.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-6-methoxy-3,6,8,8-tetramethyl-1H-3a,7-methanoazulene",67874-81-1, Repeated dosetoxicity: NOAEL: ≥ 330 mg/kg bw/day corresponding to ≥ 6000 mg/kg diet (OECD TG 422) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aea02be0-9062-4421-8532-5647f97dc3ca/documents/IUC5-843a255a-83b9-44c9-a88f-486cb4c4efee_0e3bca97-327d-49a2-994b-bb4f6c5ed15d.html,,,,,, "[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-6-methoxy-3,6,8,8-tetramethyl-1H-3a,7-methanoazulene",67874-81-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aea02be0-9062-4421-8532-5647f97dc3ca/documents/IUC5-843a255a-83b9-44c9-a88f-486cb4c4efee_0e3bca97-327d-49a2-994b-bb4f6c5ed15d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,330 mg/kg bw/day,,rat "[3R-(3α,3aβ,6α,7β,8aα)]-octahydro-6-methoxy-3,6,8,8-tetramethyl-1H-3a,7-methanoazulene",67874-81-1, Acute oral toxicity: similar to OECD TG 401: LD50 > 5000 mg/kg bw Acute dermal toxicity: similar to OECD TG 402: LD50 > 5000 mg/kg bw Acute inhalation toxicity: route to route extrapolation from oral: > 13000 mg/m3. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aea02be0-9062-4421-8532-5647f97dc3ca/documents/IUC5-88352402-e0e9-4f35-ae84-438ec634d87b_0e3bca97-327d-49a2-994b-bb4f6c5ed15d.html,,,,,, "[1R-(1α,4β,4aα,6β,8aα)]-octahydro-4,8a,9,9-tetramethyl-1,6-methano-1(2H)-naphthol",5986-55-0, Acute oral toxicity: OECD TG 401: LD50 >5000 mg/kg bw based on read-across from Patchouli oil. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce03e293-893c-44cf-8af2-aceda77033bc/documents/6736ffc8-4431-4540-80bc-38c8e29bdeff_f6082c79-a2bd-4811-9988-0b8dc8a822ab.html,,,,,, Octanal,124-13-0,Repeated dose toxicity: via oral route: short-term NOAEL (rat / combined) = at least 1000 mg/kg bw/day (OECD 422 / GLP / K. Rel.1) subchronic NOAEL (rat / 90-days) = at least 1000 mg/kg bw/day (read-across / OECD 408 / GLP / K. Rel.1) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db358724-dee5-4686-9f97-99b948233df4/documents/IUC5-9225187c-3081-47ae-9504-1bf87932e664_16dcc7cb-3256-4715-be12-9844e5f1f624.html,,,,,, Octanal,124-13-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db358724-dee5-4686-9f97-99b948233df4/documents/IUC5-9225187c-3081-47ae-9504-1bf87932e664_16dcc7cb-3256-4715-be12-9844e5f1f624.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"> 1,000 mg/kg bw/day",,rat Octanal,124-13-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db358724-dee5-4686-9f97-99b948233df4/documents/IUC5-9225187c-3081-47ae-9504-1bf87932e664_16dcc7cb-3256-4715-be12-9844e5f1f624.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"> 1,000 mg/kg bw/day",,rat Octanal,124-13-0,"- Acute toxicity via Oral route: LD50 (rat / male) = 4617 mg/kg bw (no guideline / non-GLP /, K / Rel.2) - Acute toxicity via Dermal route: LD50 (rabbit / male) = 5207 mg/kg bw (no guideline / non-GLP / K / Rel.2)  - Acute toxicity via Inhalation route: LC50 (rat / male / vapors) >  0.83 mg/L (no guideline / non-GLP / K / Rel.2) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db358724-dee5-4686-9f97-99b948233df4/documents/IUC5-0c44364f-fcc5-4ba4-b2b3-68a0ff02cbc5_16dcc7cb-3256-4715-be12-9844e5f1f624.html,,,,,, Octanal,124-13-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db358724-dee5-4686-9f97-99b948233df4/documents/IUC5-0c44364f-fcc5-4ba4-b2b3-68a0ff02cbc5_16dcc7cb-3256-4715-be12-9844e5f1f624.html,,oral,LD50,"ca.4,617 mg/kg bw",no adverse effect observed, Octanal,124-13-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db358724-dee5-4686-9f97-99b948233df4/documents/IUC5-0c44364f-fcc5-4ba4-b2b3-68a0ff02cbc5_16dcc7cb-3256-4715-be12-9844e5f1f624.html,,dermal,LD50,"ca.5,207 mg/kg bw",no adverse effect observed, Octanal,124-13-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db358724-dee5-4686-9f97-99b948233df4/documents/IUC5-0c44364f-fcc5-4ba4-b2b3-68a0ff02cbc5_16dcc7cb-3256-4715-be12-9844e5f1f624.html,,inhalation,LC50,> 830 mg/m3,no adverse effect observed, "1,1-dimethoxyoctane",10022-28-3, Acute oral toxicity (OECD TG 401): LD50 >2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b61026bf-c3f6-43f6-8a81-9424fba87b92/documents/440cdf2a-9069-44c3-97d4-d0c4770c7fc7_8d7aa5c3-e390-4fd3-a66f-53d09bbc3af6.html,,,,,, Octane,111-65-9, Repeated Dose Oral 90d - NOAEL ≥ 500 mg/kg bw/day for rats (OECD 408); BMDL = 1857 mg/kg bw/day Repeated Dose Inhalation 90d – NOAEC ≥ 24300 mg/m3 for rats (similar to OECD TG 413) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60db3600-aaed-4c93-804c-e11003342512/documents/67881181-0862-4d78-8a79-a646cc84d2b9_1aba7ec8-6a16-4b31-bec6-f8fc4a33d18d.html,,,,,, Octane,111-65-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60db3600-aaed-4c93-804c-e11003342512/documents/67881181-0862-4d78-8a79-a646cc84d2b9_1aba7ec8-6a16-4b31-bec6-f8fc4a33d18d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Octane,111-65-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60db3600-aaed-4c93-804c-e11003342512/documents/67881181-0862-4d78-8a79-a646cc84d2b9_1aba7ec8-6a16-4b31-bec6-f8fc4a33d18d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"24,300 mg/m3",,rat Octane,111-65-9, Oral LD50 (rat) > 5000 mg/kg bw Inhalation LC50 (rat) > 24880 mg/m3 Dermal LD50 (rabbit) > 2000 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60db3600-aaed-4c93-804c-e11003342512/documents/af625a4a-3422-4df5-9899-643d95a9eca5_1aba7ec8-6a16-4b31-bec6-f8fc4a33d18d.html,,,,,, Octane,111-65-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60db3600-aaed-4c93-804c-e11003342512/documents/af625a4a-3422-4df5-9899-643d95a9eca5_1aba7ec8-6a16-4b31-bec6-f8fc4a33d18d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Octane,111-65-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60db3600-aaed-4c93-804c-e11003342512/documents/af625a4a-3422-4df5-9899-643d95a9eca5_1aba7ec8-6a16-4b31-bec6-f8fc4a33d18d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Octane,111-65-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60db3600-aaed-4c93-804c-e11003342512/documents/af625a4a-3422-4df5-9899-643d95a9eca5_1aba7ec8-6a16-4b31-bec6-f8fc4a33d18d.html,,inhalation,LC50,"24,880 mg/m3",no adverse effect observed, Oct-1-ene,111-66-0," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5cd9d3af-16be-4069-8d2a-321efbb5ea03/documents/6ca14707-dde7-48bd-abec-75c806c0ebdf_8c745a50-4422-4499-859b-52cfebfaa338.html,,,,,, Oct-1-ene,111-66-0,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cd9d3af-16be-4069-8d2a-321efbb5ea03/documents/45ca0969-61bb-4dee-8151-72b330ca389f_8c745a50-4422-4499-859b-52cfebfaa338.html,,,,,, "N,N'-(decane-1,10-diyldi-1(4H)-pyridyl-4-ylidene)bis(octylammonium) dichloride",70775-75-6," The LD50 of octenidine dihydrochloride in rats was 800 mg/kg bw, in rabbits the LD50 lies presumably between 250 and 800 mg/kg bw. Poisoning symptoms were independent of the species tested and included ataxia, dyspnoea, reduced motor activity, loose or dark stools. Further, reduced body weight gain or body weight loss was observed in the post exposure period. At necropsy, hyperaemia and ulcers of the stomach were seen as well as adhesions of the stomach to the liver. It is likely that these symptoms are the result of the antiseptic effects of octenidine dihydrochloride in the gastroinintestinal tract resulting in a loss of intestinal flora, and thus malnutrition and increased intestinal gas production. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3606eec1-ad4f-44df-a8b1-adf79c6526f8/documents/458177f2-3cf9-4907-8d47-133b8f2275ee_e2f25329-d33d-476b-b8a0-0e9104051e58.html,,,,,, "N,N'-(decane-1,10-diyldi-1(4H)-pyridyl-4-ylidene)bis(octylammonium) dichloride",70775-75-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3606eec1-ad4f-44df-a8b1-adf79c6526f8/documents/458177f2-3cf9-4907-8d47-133b8f2275ee_e2f25329-d33d-476b-b8a0-0e9104051e58.html,,oral,LD50,800 mg/kg bw,adverse effect observed, Octocrilene,6197-30-4,"In the chosen key study according to OECD TG 408 and GLP, substance-related effects were observed at dose levels of 4500 ppm and 15000 ppm, corresponding to 340 and 1085 mg/kg bw/day. Identified target organs were the liver, thyroid and pituitary gland as a secondary consequence of hepatic enzyme induction. The slight changes seen in the red blood cells of the high dose females are probably related to a marginal adverse effect of the test substance at high dose level. Based upon the above mentioned findings, the no observed adverse effect level under the conditions of this study is set at 175 mg/kg bw/day for males and females. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8819906f-f574-452a-bc54-2f0185ac3b21/documents/IUC5-ea806978-9394-4141-a0db-a71dd03e47ed_5a54ab01-9396-428c-8124-834d1193c8cd.html,,,,,, Octocrilene,6197-30-4,"Acute oral toxicity is assessed in a study according to OECD test guideline 401, resulting in an LD50 > 5000 mg/kg body weight.Acute dermal toxicity is assessed in a study according to OECD test guideline 402, resulting in an LD50 > 2000 mg/kg body weight. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8819906f-f574-452a-bc54-2f0185ac3b21/documents/IUC5-6a37e56d-1ea9-4ca2-9f58-c3bdeeb166bf_5a54ab01-9396-428c-8124-834d1193c8cd.html,,,,,, Octocrilene,6197-30-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8819906f-f574-452a-bc54-2f0185ac3b21/documents/IUC5-6a37e56d-1ea9-4ca2-9f58-c3bdeeb166bf_5a54ab01-9396-428c-8124-834d1193c8cd.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Octocrilene,6197-30-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8819906f-f574-452a-bc54-2f0185ac3b21/documents/IUC5-6a37e56d-1ea9-4ca2-9f58-c3bdeeb166bf_5a54ab01-9396-428c-8124-834d1193c8cd.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol",3147-75-9,"read-across CAS 2440-22-4: OECD 452, chronic rat feeding study - NOAEL = 142 - 169 mg/kg bwread-across CAS 2440-22-4: OECD 422, rat screening, gavage study - NOAEL = 30 mg/kg bw ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad55f582-4db4-4acb-aadb-0174bf18846f/documents/IUC5-57bd4435-78ce-40b8-86d0-0ab8266b4beb_0eb0192b-7f55-47c4-b61c-331471def278.html,,,,,, "2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol",3147-75-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad55f582-4db4-4acb-aadb-0174bf18846f/documents/IUC5-57bd4435-78ce-40b8-86d0-0ab8266b4beb_0eb0192b-7f55-47c4-b61c-331471def278.html,Chronic toxicity – systemic effects,oral,NOAEL,142 mg/kg bw/day,,rat "2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol",3147-75-9,- LD50 acute oral toxicity (male; rat): > 10000 mg/kg bw (reliability score: 2)- LD50 acute dermal toxicity (male; rabbit): > 5000 mg/kg bw (reliability score: 2) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad55f582-4db4-4acb-aadb-0174bf18846f/documents/IUC5-8cf42a1c-88b1-4474-849e-2321fc37f491_0eb0192b-7f55-47c4-b61c-331471def278.html,,,,,, "2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol",3147-75-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad55f582-4db4-4acb-aadb-0174bf18846f/documents/IUC5-8cf42a1c-88b1-4474-849e-2321fc37f491_0eb0192b-7f55-47c4-b61c-331471def278.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "2-(2H-benzotriazol-2-yl)-4-(1,1,3,3-tetramethylbutyl)phenol",3147-75-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad55f582-4db4-4acb-aadb-0174bf18846f/documents/IUC5-8cf42a1c-88b1-4474-849e-2321fc37f491_0eb0192b-7f55-47c4-b61c-331471def278.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Octyl acetate,112-14-1,Octyl acetate is not a toxicant upon repeated exposure by oral route. ,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/120adf93-f541-405f-81d3-3cd80b91ac98/documents/IUC5-a8415b17-b327-4067-80d1-e06c581cf986_982fdf25-5656-455d-9ffe-d6fd216d93df.html,,,,,, Octyl acetate,112-14-1,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/120adf93-f541-405f-81d3-3cd80b91ac98/documents/IUC5-a8415b17-b327-4067-80d1-e06c581cf986_982fdf25-5656-455d-9ffe-d6fd216d93df.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Octyl acetate,112-14-1,Acetate C-8 is likely to be non hazardous by oral and dermal route of exposure in rats and rabbits. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/120adf93-f541-405f-81d3-3cd80b91ac98/documents/IUC5-65e8ca62-068a-4176-8a82-ef906e192428_982fdf25-5656-455d-9ffe-d6fd216d93df.html,,,,,, Octyl acetate,112-14-1,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/120adf93-f541-405f-81d3-3cd80b91ac98/documents/IUC5-65e8ca62-068a-4176-8a82-ef906e192428_982fdf25-5656-455d-9ffe-d6fd216d93df.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, Octyl acetate,112-14-1,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/120adf93-f541-405f-81d3-3cd80b91ac98/documents/IUC5-65e8ca62-068a-4176-8a82-ef906e192428_982fdf25-5656-455d-9ffe-d6fd216d93df.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-octyldodecan-1-ol,5333-42-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75f2af05-fc3f-41a4-a990-67a3e7b766df/documents/IUC5-b49094d0-2faa-4ed8-891c-40aae58ea162_fc68a2c6-c290-402f-bafa-066017162ed6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,839.6 mg/kg bw/day,, 2-octyldodecan-1-ol,5333-42-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75f2af05-fc3f-41a4-a990-67a3e7b766df/documents/IUC5-432ef93a-b9f5-48c6-bf59-21c9109a8154_fc68a2c6-c290-402f-bafa-066017162ed6.html,,oral,discriminating dose,"42,316 mg/kg bw",no adverse effect observed, 2-octyldodecan-1-ol,5333-42-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75f2af05-fc3f-41a4-a990-67a3e7b766df/documents/IUC5-432ef93a-b9f5-48c6-bf59-21c9109a8154_fc68a2c6-c290-402f-bafa-066017162ed6.html,,dermal,discriminating dose,"1,679 mg/kg bw",no adverse effect observed, 2-octyldodecyl isooctadecanoate,93803-87-3,NOAEL systemic= 300 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be9fe4fc-e462-4647-bc06-a5f2cbd9b5bd/documents/IUC5-5ebc1a53-527b-484d-b6cf-fd1242616a5d_94692f97-480a-4163-abf8-a16161b91e2d.html,,,,,, 2-octyldodecyl isooctadecanoate,93803-87-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be9fe4fc-e462-4647-bc06-a5f2cbd9b5bd/documents/IUC5-5ebc1a53-527b-484d-b6cf-fd1242616a5d_94692f97-480a-4163-abf8-a16161b91e2d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 2-octyldodecyl isooctadecanoate,93803-87-3,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be9fe4fc-e462-4647-bc06-a5f2cbd9b5bd/documents/IUC5-b978fe4c-1f67-4f16-bed5-0f50fbcbb1bd_94692f97-480a-4163-abf8-a16161b91e2d.html,,,,,, 2-octyldodecyl myristate,22766-83-2,"Oral: OECD 422, rat, NOAEL ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92b4eb16-245c-4577-940d-bc8015ca8c9b/documents/IUC5-722aa986-0b04-4ae9-beed-94e74d915663_518dffbe-61ad-4faf-847d-1a8b29eac162.html,,,,,, 2-octyldodecyl myristate,22766-83-2,Oral: LD50 > 29.75 g/kg bw Inhalation: LC50 > 5.7 mg/LDermal: LD50 > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92b4eb16-245c-4577-940d-bc8015ca8c9b/documents/IUC5-73281ffc-a525-4a29-ba72-bc7ba93e9b21_518dffbe-61ad-4faf-847d-1a8b29eac162.html,,,,,, 2-octyldodecyl 5-oxo-L-prolinate,37673-37-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/434d5991-0fab-43d1-a31d-6125b1d74697/documents/d305a3be-5d00-40a7-bff4-24de31a4e377_6027fac2-d07b-4c2c-8792-0dec6655d8a3.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, octhilinone (ISO); 2-octyl-2H-isothiazol-3-one,26530-20-1," From the assessment report of this substance as wood preservative (January 2017): The main adverse effect of repeated oral exposure to OIT is local irritation of the stomach, observed in rat studies. The most sensitive oral NOAEC for medium-term and long-term exposure is 500 ppm in the diet, reported in an 18 month study in mice. There is no clear evidence of systemic toxicity in any of the studies; reduced bodyweight gain was observed in some studies, but this is likely to be secondary to local stomach irritation or due to poor palatability of test diets. The most sensitive oral NOAEL for systemic effects is 65 mg/kg bw/d identified from the 18-month dietary study in mice and based on reductions in body weight. Lower oral systemic NOAELs were identified for maternal toxicity in the gavage developmental rat toxicity study (5 mg/kg bw/d) and in the gavage rabbit developmental toxicity study (20 mg/kg bw/d); however, it is most likely the systemic effects (reductions in body weight and food consumption) observed in these studies were secondary to the local stomach irritation, which had been exacerbated by the method of test substance administration (gavage) employed in the studies. At WGII 2014 it was agreed that derivation of systemic AELs from these oral gavage NOAELs and extrapolation to systemic effects via the dermal and inhalation route would not be appropriate. By the dermal route, repeated exposure to OIT causes local skin irritation of dose-related severity, as would be expected for a corrosive substance. A dermal NOAEC for local effects of 0.5% (0.02 mg/cm2) was identified in one 90-day study (6 h/day) in the rat, using a semi occluded application site. An overall dermal NOAEC of 0.3%, taken from the LOEP, for OIT local irritation on repeated exposure was agreed at WGII 2014. It should be noted however that skin sensitisation is the most sensitive dermal local effect, with an indicative human NOAEC of 0.005% (50 ppm). From the LOEP an overall NOAEL for systemic toxicity of 1.5 % (15 mg/kg/day) was identified (agreed at WGII 2014). The applicant has not submitted data on the short-term or subchronic repeated exposure toxicity for the inhalation route, which for the reasons given is considered to be acceptable. A NOAEC is 0.64 mg/m3 is taken from the LOEP agreed at WGII 2014. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9fca9dc-2c66-4641-9e17-e5a334954f54/documents/df158997-37a6-434f-8509-dec762c6cbe6_330651b1-5106-432b-a86a-f86a534003e0.html,,,,,, octhilinone (ISO); 2-octyl-2H-isothiazol-3-one,26530-20-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9fca9dc-2c66-4641-9e17-e5a334954f54/documents/df158997-37a6-434f-8509-dec762c6cbe6_330651b1-5106-432b-a86a-f86a534003e0.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,15 mg/kg bw/day,,rat octhilinone (ISO); 2-octyl-2H-isothiazol-3-one,26530-20-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9fca9dc-2c66-4641-9e17-e5a334954f54/documents/df158997-37a6-434f-8509-dec762c6cbe6_330651b1-5106-432b-a86a-f86a534003e0.html,Chronic toxicity – systemic effects,oral,NOAEL,65 mg/kg bw/day,,mouse octhilinone (ISO); 2-octyl-2H-isothiazol-3-one,26530-20-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9fca9dc-2c66-4641-9e17-e5a334954f54/documents/74dc4038-db70-415f-ac20-58c75273e668_330651b1-5106-432b-a86a-f86a534003e0.html,,oral,LD50,125 mg/kg bw,adverse effect observed, octhilinone (ISO); 2-octyl-2H-isothiazol-3-one,26530-20-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9fca9dc-2c66-4641-9e17-e5a334954f54/documents/74dc4038-db70-415f-ac20-58c75273e668_330651b1-5106-432b-a86a-f86a534003e0.html,,dermal,LD50,311 mg/kg bw,adverse effect observed, octhilinone (ISO); 2-octyl-2H-isothiazol-3-one,26530-20-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9fca9dc-2c66-4641-9e17-e5a334954f54/documents/74dc4038-db70-415f-ac20-58c75273e668_330651b1-5106-432b-a86a-f86a534003e0.html,,inhalation,LC50,270 mg/m3,adverse effect observed, N-(2-hydroxypropyl)oleamide,111-05-7," Three repeated dose toxicity studies were performed (OECD 422, OECD 408 and OECD 414) ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/37701c70-d57b-454c-9ffb-0dcf8a0d6cfe/documents/8e4284dd-48a6-4418-927e-701ed84e8a6e_7369786b-bdc6-4351-8c93-19fc913a1a59.html,,,,,, N-(2-hydroxypropyl)oleamide,111-05-7,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/37701c70-d57b-454c-9ffb-0dcf8a0d6cfe/documents/8e4284dd-48a6-4418-927e-701ed84e8a6e_7369786b-bdc6-4351-8c93-19fc913a1a59.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, N-(2-hydroxypropyl)oleamide,111-05-7,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/37701c70-d57b-454c-9ffb-0dcf8a0d6cfe/documents/8e4284dd-48a6-4418-927e-701ed84e8a6e_7369786b-bdc6-4351-8c93-19fc913a1a59.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat N-(2-hydroxypropyl)oleamide,111-05-7, Two acute oral and dermal toxicity studies are available (OECD 423 and OECD 402). ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37701c70-d57b-454c-9ffb-0dcf8a0d6cfe/documents/44a15b63-aa91-4ef1-b07d-6084749537ef_7369786b-bdc6-4351-8c93-19fc913a1a59.html,,,,,, N-(2-hydroxypropyl)oleamide,111-05-7,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37701c70-d57b-454c-9ffb-0dcf8a0d6cfe/documents/44a15b63-aa91-4ef1-b07d-6084749537ef_7369786b-bdc6-4351-8c93-19fc913a1a59.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, N-(2-hydroxypropyl)oleamide,111-05-7,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37701c70-d57b-454c-9ffb-0dcf8a0d6cfe/documents/44a15b63-aa91-4ef1-b07d-6084749537ef_7369786b-bdc6-4351-8c93-19fc913a1a59.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, N-[3-(dimethylamino)propyl]oleamide,109-28-4,"The substance was tested for toxicity upon repeated oral exposure in rats (according to OECD guideline 407). In the highest dose group (150 mg/kg bw/day) respiration sounds and salivation were observed in both sexes. However, no mortality occured, and no adverse effects were observed upon necropsy or pathological and clincochemical examination. Thus, no classification according to Regulation (EC) No 1272/2008 (CLP) is required. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/269abf24-9de4-4b6d-9998-261e6f98e2dd/documents/IUC5-713f3262-94ad-4c4f-be0c-55c946242bca_f19861b3-987d-4d76-9181-fcf1821f3bb5.html,,,,,, N-[3-(dimethylamino)propyl]oleamide,109-28-4,"Acute oral and dermal toxicity were tested in rats according to OECD guidelines 423 and 402, respectively. The LD50 values for both routes were >2000 mg/kg body weight. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/269abf24-9de4-4b6d-9998-261e6f98e2dd/documents/IUC5-dfcc3081-8442-45aa-b5e1-9db6b90ffe38_f19861b3-987d-4d76-9181-fcf1821f3bb5.html,,,,,, (Z)-9-Octadecen-1-ol ethoxylated,9004-98-2,"Oral (subacute, rat, m/f, OECD 422): NOAEL (systemic toxicity) ≥ 1000 mg/kg bw/day Oral (subacute, rat, m/f, OECD 422): NOAEL (local toxicity) ≥ 1000 mg/kg bw/day   Conclusion based on data obtained with (Z)-9-octadecen-1-ol, ethoxylated (CAS No. 9004-98-2, EC No. 500-016-2) and considering all the available data on repeated dose toxicity in the Alcohol Ethoxylates (AE) category, in a Weight-of-Evidence approach. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07d5fa2a-c236-42d5-9b75-176a536e6eaa/documents/4b82418d-4f56-4285-9294-33be9ea07d26_2bd2fd1e-b3a5-463a-b48b-659fbf350b90.html,,,,,, (Z)-9-Octadecen-1-ol ethoxylated,9004-98-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07d5fa2a-c236-42d5-9b75-176a536e6eaa/documents/4b82418d-4f56-4285-9294-33be9ea07d26_2bd2fd1e-b3a5-463a-b48b-659fbf350b90.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat (Z)-9-Octadecen-1-ol ethoxylated,9004-98-2,"Oral: LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute oral toxicity in the Alcohol Ethoxylates (AE) category in a Weight-of-Evidence approach.   Inhalation: No study required as the inhalation route of exposure is considered less relevant than the dermal route for AE substances.   Dermal: According to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, no study is required as the AE substances do not meet the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07d5fa2a-c236-42d5-9b75-176a536e6eaa/documents/ffaeedd3-ecc6-4618-9234-cba3bfedb569_2bd2fd1e-b3a5-463a-b48b-659fbf350b90.html,,,,,, (Z)-9-Octadecen-1-ol ethoxylated,9004-98-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07d5fa2a-c236-42d5-9b75-176a536e6eaa/documents/ffaeedd3-ecc6-4618-9234-cba3bfedb569_2bd2fd1e-b3a5-463a-b48b-659fbf350b90.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, (Z)-octadec-9-enol,143-28-2,"There are no data available for (Z)-octadec-9-enol (CAS 143-28-2; EC 205-597-3), consequently, information has been read across from similar compounds octadecan-1-ol (CAS 112-92-5 EC 204-017-6) icosan-1-ol (CAS 629-96-9, EC 211-119-4) and Alcohols, C16-19 branched (CAS 93762-74-4 EC 297-790-4). The key acute oral study for octadecan-1-ol (CAS 112-92-5 EC 204-017-6) reports an LD50 value of > 2000 mg/kg bw/day in rats conducted according to the now deleted OECD 401 test guidelines and in compliance with GLP (SafePharm Laboratories, 1996, reliability 1). Similarly, a key acute oral study for Alcohols C16-19 (CAS 93762-74-4 EC 297-790-4) found an LD50 value of > 5000 mg/kg bw/day in rats conducted according to the now deleted OECD 401 test guidelines and in compliance with GLP (WIL Research, 1998, reliability 1). The key acute dermal toxicity study for Alcohols C16-19 branched (CAS) was conducted according to OECD 434 test guideline and in compliance with GLP, reports an LD50 of > 2000 mg/kg bw/day (WIL Research Laboratories, 1998, reliability 1) The key acute dermal toxicity study for icosan-1-ol (CAS 629-96-9, EC 211-119-4) conducted prior to the establishment of OECD test guidelines and GLP, an LD50 of >16800 mg/kg bw/day (Smyth, 1969, reliability 2). No testing is required via the inhalation route since high reliability studies are already in place via the oral and dermal route. Furthermore, the LC50 for inhalation is expected to be greater than the substantially saturated vapour concentration based on evidence across the category. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6052c00d-c9f7-4e96-97a6-7043c0a8c7c7/documents/5bcf8010-1ee0-4f52-853a-e2c2f69f83f2_eac3ab32-88e1-4c58-83cb-532db6f34196.html,,,,,, (Z)-octadec-9-enol,143-28-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6052c00d-c9f7-4e96-97a6-7043c0a8c7c7/documents/5bcf8010-1ee0-4f52-853a-e2c2f69f83f2_eac3ab32-88e1-4c58-83cb-532db6f34196.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, (Z)-octadec-9-enol,143-28-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6052c00d-c9f7-4e96-97a6-7043c0a8c7c7/documents/5bcf8010-1ee0-4f52-853a-e2c2f69f83f2_eac3ab32-88e1-4c58-83cb-532db6f34196.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, (Z)-octadec-9-enyl (Z)-docos-13-enoate,17673-56-2,NOAEL systemic= 300 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74274131-e4ab-452d-bf31-7449ccf5ff2b/documents/IUC5-4bd71d4b-a618-4a8a-896e-4006b244435e_c8b2a0a6-e323-4eac-9fe1-db1106625c2b.html,,,,,, (Z)-octadec-9-enyl (Z)-docos-13-enoate,17673-56-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74274131-e4ab-452d-bf31-7449ccf5ff2b/documents/IUC5-4bd71d4b-a618-4a8a-896e-4006b244435e_c8b2a0a6-e323-4eac-9fe1-db1106625c2b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat (Z)-octadec-9-enyl (Z)-docos-13-enoate,17673-56-2,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74274131-e4ab-452d-bf31-7449ccf5ff2b/documents/IUC5-697bd081-0ada-46b5-85ce-fd4b6e31b629_c8b2a0a6-e323-4eac-9fe1-db1106625c2b.html,,,,,, (Z)-octadec-9-enyl oleate,3687-45-4,NOAEL systemic= 300 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e64bcc03-8a6f-4933-ba0b-deb0fc545996/documents/IUC5-206858de-daa0-4bf8-9954-f2c2f1a12132_acfc90ed-a83e-4b9c-903d-05681350adc1.html,,,,,, (Z)-octadec-9-enyl oleate,3687-45-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e64bcc03-8a6f-4933-ba0b-deb0fc545996/documents/IUC5-206858de-daa0-4bf8-9954-f2c2f1a12132_acfc90ed-a83e-4b9c-903d-05681350adc1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat (Z)-octadec-9-enyl oleate,3687-45-4,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e64bcc03-8a6f-4933-ba0b-deb0fc545996/documents/IUC5-4dce5431-5234-4fc9-b1be-658f174ceee2_acfc90ed-a83e-4b9c-903d-05681350adc1.html,,,,,, (Z)-N-octadec-9-enylhexadecan-1-amide,16260-09-6,"Oral (OECD 408, diet), rat: NOAEL ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f55faa41-9e08-425d-b974-e143cf660742/documents/e428325c-c077-43dc-8437-890feed1fd78_4aca4818-5b04-472d-8642-1fe176cf815e.html,,,,,, (Z)-N-octadec-9-enylhexadecan-1-amide,16260-09-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f55faa41-9e08-425d-b974-e143cf660742/documents/e428325c-c077-43dc-8437-890feed1fd78_4aca4818-5b04-472d-8642-1fe176cf815e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat (Z)-N-octadec-9-enylhexadecan-1-amide,16260-09-6," Oral (OECD 401), rat: LD50 > 2400 mg/kg bwDermal (OECD 402), rat: LD50 > 2000 mg/kg bw Inhalation: no study available ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f55faa41-9e08-425d-b974-e143cf660742/documents/c8728092-1e30-4f2e-8e23-98edffb2c3b8_4aca4818-5b04-472d-8642-1fe176cf815e.html,,,,,, "Marjoram, sweet, ext.",84082-58-6," In an acute oral toxicity study, the oral LD50 of Essential oil of Marjoram was higher than 5000 mg/kg bw in rats (Rel. K2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c708d22-5d10-4a05-994e-573461a8efc9/documents/ae9e2c7d-6d09-4418-9958-56b89ffa4a47_02c9dbaa-1719-48b5-8a13-f118423608bd.html,,,,,, "Marjoram, sweet, ext.",84082-58-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c708d22-5d10-4a05-994e-573461a8efc9/documents/ae9e2c7d-6d09-4418-9958-56b89ffa4a47_02c9dbaa-1719-48b5-8a13-f118423608bd.html,,oral,LD50,"5,000 mg/kg bw",adverse effect observed, "L-(+)-2,5-diaminopentanoic acid",3184-13-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch 1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34557063-52c7-4001-a9ff-7212465b243c/documents/b6a09744-d4cb-4602-a09c-fdb0b485af8d_f4dd63ec-b1e4-424d-8c25-0e48072af545.html,,,,,, "L-(+)-2,5-diaminopentanoic acid",3184-13-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34557063-52c7-4001-a9ff-7212465b243c/documents/b6a09744-d4cb-4602-a09c-fdb0b485af8d_f4dd63ec-b1e4-424d-8c25-0e48072af545.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,445 mg/kg bw/day",,rat "L-(+)-2,5-diaminopentanoic acid",3184-13-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 1 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34557063-52c7-4001-a9ff-7212465b243c/documents/094b01f9-8cae-45d5-9ba2-09cfd4c43025_f4dd63ec-b1e4-424d-8c25-0e48072af545.html,,,,,, "L-(+)-2,5-diaminopentanoic acid",3184-13-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34557063-52c7-4001-a9ff-7212465b243c/documents/094b01f9-8cae-45d5-9ba2-09cfd4c43025_f4dd63ec-b1e4-424d-8c25-0e48072af545.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Oxacycloheptadec-10-en-2-one,28645-51-4," Repeated dose toxicity - via oral route: A repeated dose 28-day oral toxicity study was performed to determine the toxic profile ofthe test chemical when administered daily for 28 consecutive days for Sprague-Dawley rats. The test substance was administered to rats at dose levels of0 (vehicle control), 250, 500 and 1000 mg/kg body weight/day. Two additional doseswere added to the study as control (0 mg/kg/day) and 1000 mg/kg/day in order to study delayed toxiceffects orreversibilityy. The control animals were administered with corn oil. All treated animals were survived through the dosing period of 28-day and the recovery period of 14-days. No sign of toxicity was noted throughout the dosing and recovery periods. Treated rats exhibited normal body weight gain and the food consumption, which were comparable with controls. Detailed clinical observation conducted weekly did not reveal any abnormalities at any dose during the dosing and recovery periods. Ophthalmoscopic examination, conducted prior to and after the dosing period did not reveal any abnormalities.At the end of administration period, in week 4th functional observation battery was performed to assess sensory reactivity to diverse stimulus, grip strength and motor activity. This functional observational battery did not reveal any differences between treated and control rats.Haematological analysis was carried out on termination days (day 29 and 43) and it did not reveal any abnormalities. In clinical biochemistry the total protein level, which reflectsthetotal amount of albumin and globulin, was significantly decreased at 500 and 1000 mg/kg/day in males and at 500 mg/kg/day in females. Creatinine concentration dropped significantly at the top dose in males, but no similar changes were seen in females. In females the alanine transaminase (ALT) and alkaline phosphatase (ALP) levels, which are indicators of liver function dropped significantly at 250, and 500 mg/kg/day, and theALTlevelin serumremained reduced at day 43. However, no similar effects on serum liver enzymes concentration was seen in male rats. In summary, no conclusive and dose-dependent alteration of serum parameters were revealed, the observed increase/decrease in concentrations were marginal and within the normal laboratory and biological limits.At the end of dosing period of 28-day, the relative weight of kidney and adrenals decreased significantly at 1000 mg/kg/day as compared to control, but no similar effect was noted among females. At the termination of recovery period (at day 43) the relative weight of liver, kidney and spleen increased significantly in both males and females. Although significant changes in organ weight were observed in male and female rats in different dose group, no related gross pathological and histopathological finding were seen and therefore, these finding were considered to be of no toxicological importance. Gross pathological and histopathological observation of organs did not reveal abnormalities at any dose level in both sexes. In conclusion, the repeated oral exposure tothe test chemicaldid notinduced toxicologically significant and severe alterations of the function or morphology of a specific tissue/organ, neither produced serious changes to the biochemistry or haematology of animalswhen SD rats were orally administered for 28 consecutive days followed by a 14-day recovery period. Repeated dose toxicity - via inhalation route: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Considering the low vapour pressure of the substance oxacycloheptadec-10-en-2-one (28645-51-4) which is reported as 2.2351839 10-5Hgmm at 25°C. Thus, exposure to inhalable dust, mist and vapour of the chemical oxacycloheptadec-10-en-2-one is highly unlikely and therefore this study is considered for waiver.   Repeated dose toxicity - via dermal route: The acute toxicity value for oxacycloheptadec-10-en-2-one (28645-51-4) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that oxacycloheptadec-10-en-2-one shall not exhibit toxic effects via dermal exposure after exposure of 28 consecutive days. In addition, there is no data available that suggests that oxacycloheptadec-10-en-2-one shall exhibit repeated dose toxicity via dermal route and, consequently this endpoint was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ddfc41e7-ca9b-465b-a70e-33b9298057e6/documents/3173bdd0-4252-4c03-a463-22a2af81056f_ec02b2c8-16bb-46ce-84a4-7751e8691521.html,,,,,, Oxacycloheptadec-10-en-2-one,28645-51-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ddfc41e7-ca9b-465b-a70e-33b9298057e6/documents/3173bdd0-4252-4c03-a463-22a2af81056f_ec02b2c8-16bb-46ce-84a4-7751e8691521.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Oxacycloheptadec-10-en-2-one,28645-51-4," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 2.24E-5 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ddfc41e7-ca9b-465b-a70e-33b9298057e6/documents/7d0cbb71-1a25-4708-a700-7f0b3d328166_ec02b2c8-16bb-46ce-84a4-7751e8691521.html,,,,,, Oxacycloheptadec-10-en-2-one,28645-51-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ddfc41e7-ca9b-465b-a70e-33b9298057e6/documents/7d0cbb71-1a25-4708-a700-7f0b3d328166_ec02b2c8-16bb-46ce-84a4-7751e8691521.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Oxacycloheptadec-10-en-2-one,28645-51-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ddfc41e7-ca9b-465b-a70e-33b9298057e6/documents/7d0cbb71-1a25-4708-a700-7f0b3d328166_ec02b2c8-16bb-46ce-84a4-7751e8691521.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Oxalic acid,144-62-7," Since no adverse effects were observed at highest tested dose i.e., 1000 PPM, the same was selected as NOAEL. The 1000 PPM is equivalent to 63 mg/kg body weight (actual test item consumed  by the animals).   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e3c3a7e-e238-43c5-bc68-854d3212df1b/documents/da443a87-aa65-4011-b675-0ef2fcb1f48f_1ca2d2ac-bca7-4b33-9cad-726c20cae003.html,,,,,, Oxalic acid,144-62-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e3c3a7e-e238-43c5-bc68-854d3212df1b/documents/da443a87-aa65-4011-b675-0ef2fcb1f48f_1ca2d2ac-bca7-4b33-9cad-726c20cae003.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,63 mg/kg bw/day,,rat Oxalic acid,144-62-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Data waiving ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e3c3a7e-e238-43c5-bc68-854d3212df1b/documents/ceee33a6-7c68-4e20-99ef-d722bf897444_1ca2d2ac-bca7-4b33-9cad-726c20cae003.html,,,,,, Oxalic acid,144-62-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e3c3a7e-e238-43c5-bc68-854d3212df1b/documents/ceee33a6-7c68-4e20-99ef-d722bf897444_1ca2d2ac-bca7-4b33-9cad-726c20cae003.html,,oral,LD50,375 mg/kg bw,adverse effect observed, Oxalic acid,144-62-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e3c3a7e-e238-43c5-bc68-854d3212df1b/documents/ceee33a6-7c68-4e20-99ef-d722bf897444_1ca2d2ac-bca7-4b33-9cad-726c20cae003.html,,dermal,LD50,"20,000 mg/kg bw",no adverse effect observed, Oxalacetic acid,328-42-7, oral: The acute oral LD50 value of the test item was between 2000 mg/kg bw and 5000 mg/kg bw in female Crl:(WI)BR rats. The test item was ranked into Category 5 of the Globally Harmonized Classification System (GHS) according to OECD Guideline No. 423. But not to be classified according to Regulation (EC) No 1272/2008 (CLP) (reference 7.2.1 -1). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c9672a1-c857-47e6-a7b1-a1630e24fe25/documents/8238b793-07d2-486c-b9fa-f4f1ec7bf8c9_00c7d676-4bdd-4c8d-a95c-d36be38b7697.html,,,,,, Oxalacetic acid,328-42-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c9672a1-c857-47e6-a7b1-a1630e24fe25/documents/8238b793-07d2-486c-b9fa-f4f1ec7bf8c9_00c7d676-4bdd-4c8d-a95c-d36be38b7697.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, Quinolin-8-ol,148-24-3, OECD 422 (rat; male/female) NOAEL 200 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d48ab022-f6cc-4481-b45b-3150a0b58000/documents/4e1e290c-9b75-4067-b364-6ef4b7f0b722_1bc98f53-cfe1-421b-95a1-30c1e8f736b7.html,,,,,, Quinolin-8-ol,148-24-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d48ab022-f6cc-4481-b45b-3150a0b58000/documents/4e1e290c-9b75-4067-b364-6ef4b7f0b722_1bc98f53-cfe1-421b-95a1-30c1e8f736b7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Quinolin-8-ol,148-24-3," acute toxicity, oral (OECD 401, RL2), rats: LD50 = 790 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d48ab022-f6cc-4481-b45b-3150a0b58000/documents/c5b8d722-3581-4092-a78d-10de6da4ef64_1bc98f53-cfe1-421b-95a1-30c1e8f736b7.html,,,,,, Quinolin-8-ol,148-24-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d48ab022-f6cc-4481-b45b-3150a0b58000/documents/c5b8d722-3581-4092-a78d-10de6da4ef64_1bc98f53-cfe1-421b-95a1-30c1e8f736b7.html,,oral,LD50,790 mg/kg bw,adverse effect observed, Bis(8-hydroxyquinolinium) sulphate,134-31-6, LD50 (oral) = 84.18 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44b45140-a874-4368-b94e-0d831df46c2d/documents/effc92fa-9dfe-44bf-8ad0-90c0db9c218a_42001c51-a0e9-46ed-9ef1-268da21760b4.html,,,,,, Bis(8-hydroxyquinolinium) sulphate,134-31-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44b45140-a874-4368-b94e-0d831df46c2d/documents/effc92fa-9dfe-44bf-8ad0-90c0db9c218a_42001c51-a0e9-46ed-9ef1-268da21760b4.html,,oral,LD50,84.18 mg/kg bw,adverse effect observed, 4-aminophenol,123-30-8,"The following Klimisch 1 studies have been conducted: (1) a subchronic study (90 days) conducted according to GLP and per OECD guideline in the rat with a NOAEL of 10 mg/kg bw/day and a LOAEL of 30 mg/kg bw/day and (2) a subacute toxicity study (28-day) conducted according to GLP and per OECD guideline in the rat with a NOAEL of 20 mg/kg bw/day. The NOAEL from the 90-day study was used to calculate the DNEL, long-term inhalation route systemic and DNEL, long term dermal route systemic. The primary target organ of toxicity in the 28-day study and 90-day study was the kidney. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b389a8fe-00b0-458f-8d04-d3e61c4f2583/documents/IUC5-1026c6c1-6115-4cbd-a533-190e31464c65_41d2a373-eede-4246-94c6-064a7c35ca34.html,,,,,, 4-aminophenol,123-30-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b389a8fe-00b0-458f-8d04-d3e61c4f2583/documents/IUC5-1026c6c1-6115-4cbd-a533-190e31464c65_41d2a373-eede-4246-94c6-064a7c35ca34.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat 4-aminophenol,123-30-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b389a8fe-00b0-458f-8d04-d3e61c4f2583/documents/IUC5-8f68c0b6-22db-490d-a399-4678fa436f2c_41d2a373-eede-4246-94c6-064a7c35ca34.html,,oral,LD50,671 mg/kg bw,adverse effect observed, 4-aminophenol,123-30-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b389a8fe-00b0-458f-8d04-d3e61c4f2583/documents/IUC5-8f68c0b6-22db-490d-a399-4678fa436f2c_41d2a373-eede-4246-94c6-064a7c35ca34.html,,dermal,LD50,"8,000 mg/kg bw",, 4-aminophenol,123-30-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b389a8fe-00b0-458f-8d04-d3e61c4f2583/documents/IUC5-8f68c0b6-22db-490d-a399-4678fa436f2c_41d2a373-eede-4246-94c6-064a7c35ca34.html,,inhalation,LC50,3.42 mg/m3,, p-anisic acid,100-09-4," short-term repeated dose toxicity (OECD 422), oral, rat: systemic NOAEL 500 mg/kg bw/day (highest dose tested) Read-across from anisaldehyde (CAS 123-11-5) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36252d9b-aa1c-4362-8100-58ce7cbaa43e/documents/9718d5de-2c76-425e-b164-0834ff626dbf_db5c36af-fa1c-48a7-85c9-550318f58f2f.html,,,,,, p-anisic acid,100-09-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36252d9b-aa1c-4362-8100-58ce7cbaa43e/documents/9718d5de-2c76-425e-b164-0834ff626dbf_db5c36af-fa1c-48a7-85c9-550318f58f2f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat p-anisic acid,100-09-4," Oral (equivalent or similar to OECD 401), rat: LD50 > 5000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36252d9b-aa1c-4362-8100-58ce7cbaa43e/documents/18776787-f71b-4860-b5b9-2a4217ccb5c5_db5c36af-fa1c-48a7-85c9-550318f58f2f.html,,,,,, p-anisic acid,100-09-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36252d9b-aa1c-4362-8100-58ce7cbaa43e/documents/18776787-f71b-4860-b5b9-2a4217ccb5c5_db5c36af-fa1c-48a7-85c9-550318f58f2f.html,,oral,LD50,"5,000 mg/kg bw",adverse effect observed, p-methoxybenzyl acetate,104-21-2, The NOAEL for the test substance was determined to be 400 mg/kg bw/d for systemic toxicity after repeated application. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7342f66a-3274-4ad4-8fc5-b952f0ae4a38/documents/e6d8d099-2359-4576-89cd-b85a7f55f759_c420c40b-f66e-4e75-9bf7-597db81428f6.html,,,,,, p-methoxybenzyl acetate,104-21-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7342f66a-3274-4ad4-8fc5-b952f0ae4a38/documents/e6d8d099-2359-4576-89cd-b85a7f55f759_c420c40b-f66e-4e75-9bf7-597db81428f6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat p-methoxybenzyl acetate,104-21-2, Oral:  The acute oral toxicity study with 2000 mg/kg bw of the test substance caused no mortality in rats and therefore a LD0 of 2000 mg/kg bw and LD50 cut off >=5000 mg/kg bw were derived.  Dermal:  The acute dermal LD50 was determined to be greater than 2000 mg/kg bw in rats. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7342f66a-3274-4ad4-8fc5-b952f0ae4a38/documents/c88a008b-5613-4be3-ab1b-c539e7030c3d_c420c40b-f66e-4e75-9bf7-597db81428f6.html,,,,,, p-methoxybenzyl acetate,104-21-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7342f66a-3274-4ad4-8fc5-b952f0ae4a38/documents/c88a008b-5613-4be3-ab1b-c539e7030c3d_c420c40b-f66e-4e75-9bf7-597db81428f6.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, p-methoxybenzyl acetate,104-21-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7342f66a-3274-4ad4-8fc5-b952f0ae4a38/documents/c88a008b-5613-4be3-ab1b-c539e7030c3d_c420c40b-f66e-4e75-9bf7-597db81428f6.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Anisyl formate,122-91-8, Acute toxicity: oral The acute oral median lethal dose (LD50) of anisyl formate in rat was observed to be 1150.0 mg/kg b.wt. Acute toxicity: dermal The acute dermal LD50 of test compound Anisyl formate in rabbit was found to be more than 5000mg/kg b.wt. (> 5000 mg/kg b.wt.). ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52532036-f000-4fbc-99dc-fe3b5b1a653b/documents/80d89cbf-1b62-4269-b0cd-394853d0e61c_b66e1ff8-31d6-448a-ad78-66df09e30c6b.html,,,,,, Anisyl formate,122-91-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52532036-f000-4fbc-99dc-fe3b5b1a653b/documents/80d89cbf-1b62-4269-b0cd-394853d0e61c_b66e1ff8-31d6-448a-ad78-66df09e30c6b.html,,oral,LD50,"1,150 mg/kg bw",adverse effect observed, Anisyl formate,122-91-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52532036-f000-4fbc-99dc-fe3b5b1a653b/documents/80d89cbf-1b62-4269-b0cd-394853d0e61c_b66e1ff8-31d6-448a-ad78-66df09e30c6b.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Chlorocresol,59-50-7,"Repeated dose toxicity study 1: Oral NOAEL was considered to be 200 mg/kg body weight /day when rats were treated with test chemical orally. Repeated dose toxicity study 2: Oral The NOAEL was considered to be 100mg/kg bw/day. When male and female rats were treated with test chemical orally for 104 weeks. Repeated dose toxicity: Inhalation The LOAEL value of chlorocresol in 42 years old human female was observed at dose concentration of 1%. Repeated dose toxicity: Dermal The systemic NOEL was considered to be 40 mg/kg/day and the LOEL was considered to be 160 mg/kg/day based on enhanced liver pathology in both sexes. When New Zealand White rabbits   treated with test chemical for 21 days via dermal application. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): K2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): K2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): K2 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e0b7e93-5ded-48c6-9542-d176265d2ecb/documents/482514be-14b5-4fa2-b95b-9314ff6baea9_41c283f1-48df-4182-b33c-6cea6a2d9fe2.html,,,,,, Chlorocresol,59-50-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e0b7e93-5ded-48c6-9542-d176265d2ecb/documents/482514be-14b5-4fa2-b95b-9314ff6baea9_41c283f1-48df-4182-b33c-6cea6a2d9fe2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Chlorocresol,59-50-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e0b7e93-5ded-48c6-9542-d176265d2ecb/documents/482514be-14b5-4fa2-b95b-9314ff6baea9_41c283f1-48df-4182-b33c-6cea6a2d9fe2.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,40 mg/kg bw/day,,rabbit Chlorocresol,59-50-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e0b7e93-5ded-48c6-9542-d176265d2ecb/documents/482514be-14b5-4fa2-b95b-9314ff6baea9_41c283f1-48df-4182-b33c-6cea6a2d9fe2.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,"10,000 mg/L",,other:Human Chlorocresol,59-50-7,"Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is between 300 to 2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute oral toxicity class 4.   Acute Inhalation Toxicity: The acute inhalation toxicity dose (LC50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LC50 value was evaluated to be >583 mg/l air, >0.704 mg/l air and > 3 mg/l air on rat species. However, due to transient irritating effects on the respiratory tract; the test substance needs to be classified as STOT SE 3 (H335) which is also in-line with the harmonized classification (Annex VI criteria of CLP).     Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimish 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Klimish 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimish 1 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e0b7e93-5ded-48c6-9542-d176265d2ecb/documents/0ed584a6-28c3-48f8-8562-e1c00734e579_41c283f1-48df-4182-b33c-6cea6a2d9fe2.html,,,,,, Chlorocresol,59-50-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e0b7e93-5ded-48c6-9542-d176265d2ecb/documents/0ed584a6-28c3-48f8-8562-e1c00734e579_41c283f1-48df-4182-b33c-6cea6a2d9fe2.html,,oral,LD50,"1,830 mg/kg bw",no adverse effect observed, Chlorocresol,59-50-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e0b7e93-5ded-48c6-9542-d176265d2ecb/documents/0ed584a6-28c3-48f8-8562-e1c00734e579_41c283f1-48df-4182-b33c-6cea6a2d9fe2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Chlorocresol,59-50-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e0b7e93-5ded-48c6-9542-d176265d2ecb/documents/0ed584a6-28c3-48f8-8562-e1c00734e579_41c283f1-48df-4182-b33c-6cea6a2d9fe2.html,,inhalation,LC50,583 mg/m3,no adverse effect observed, 4-chlorophenol,106-48-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83d7ec46-4883-402b-afc3-d48c2266e6d8/documents/IUC5-af83548b-4ce8-492b-abf9-9113198f8632_585ff351-9a7d-41ef-8f88-98b0859ab5a4.html,,oral,LD50,988 mg/kg bw,, 4-chlorophenol,106-48-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83d7ec46-4883-402b-afc3-d48c2266e6d8/documents/IUC5-af83548b-4ce8-492b-abf9-9113198f8632_585ff351-9a7d-41ef-8f88-98b0859ab5a4.html,,dermal,LD50,"1,500 mg/kg bw",, 4-chlorophenol,106-48-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83d7ec46-4883-402b-afc3-d48c2266e6d8/documents/IUC5-af83548b-4ce8-492b-abf9-9113198f8632_585ff351-9a7d-41ef-8f88-98b0859ab5a4.html,,inhalation,LC50,11 mg/m3,, p-cresol,106-44-5,"In a subchronic toxicity study according to OECD TG 408 p-cresol was administered daily to male and female Sprague-Dawley rats by gavage at dose levels of 0, 50, 175 , 600 mg/kg bw/day diluted in corn oil (RTI 1988). Based on increased mortality, clinical signs including lethargy, exessive salivation, tremor and occasional convulsions and comas, hepatotoxicity and nephrotoxicity from 175 mg/kg bw/d onwards, the NOAEL is 50 mg/kg bw/d.Due to the corrosive properties of p-cresol to the skin it will be allocated to the moderate hazard category for local effects. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The materials/methods and results are described in detail und are sufficient for evaluation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b93b9dde-db10-465f-b38a-ea115be6a773/documents/IUC5-78c6e9b7-a445-4e43-b846-dcf9554fd472_c2978636-2278-4866-addd-1b400c56727b.html,,,,,, p-cresol,106-44-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b93b9dde-db10-465f-b38a-ea115be6a773/documents/IUC5-78c6e9b7-a445-4e43-b846-dcf9554fd472_c2978636-2278-4866-addd-1b400c56727b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat p-cresol,106-44-5,"Following single oral doses to rats the LD50 was determined 207 mg/kg bw. The LD50(dermal, rabbit) was calculated to be 301 mg/kg bw. The data base on acute inhaltion toxicity of p-cresol is very limited and does not allow a final conclusion. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The materials/methods and results are described sufficient for evaluation. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The materials/methods and results are described sufficient for evaluation. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b93b9dde-db10-465f-b38a-ea115be6a773/documents/IUC5-7084b9eb-a2da-4ff0-986f-74fb10da7457_c2978636-2278-4866-addd-1b400c56727b.html,,,,,, p-cresol,106-44-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b93b9dde-db10-465f-b38a-ea115be6a773/documents/IUC5-7084b9eb-a2da-4ff0-986f-74fb10da7457_c2978636-2278-4866-addd-1b400c56727b.html,,oral,LD50,207 mg/kg bw,adverse effect observed, p-cresol,106-44-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b93b9dde-db10-465f-b38a-ea115be6a773/documents/IUC5-7084b9eb-a2da-4ff0-986f-74fb10da7457_c2978636-2278-4866-addd-1b400c56727b.html,,dermal,LD50,301 mg/kg bw,adverse effect observed, 4-methylanisole,104-93-8,"In the chosen key study according to OECD TG 407 and GLP, oral administration of 4-methylanisole in olive oil in Wistar rats for 28 days (5 days/week) led to adverse effects on the liver and clinical symptoms, being a consequence of the irritating potential of the test substance. Under the experimental conditions chosen a NOEL of 100 mg/kg bw/d was determined for males and females for repeated dose toxicity after oral administration of the test material for 28 days. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/949f0560-51f2-46a1-80b3-fb09e3fac507/documents/IUC5-7a71685b-0738-4012-95dc-9bd65809c397_cb7c8ae0-4f7e-4e27-8aeb-a543a274ba4c.html,,,,,, 4-methylanisole,104-93-8,"Acute oral toxicity was assessed in two studies similar to OECD test guideline 401, resulting in a LD50 of 1920 mg/kg body weight in rats and an LD50 between 1940 and 4850 mg/kg body weight in mice.In the key study for acute inhalative toxicity according to OECD test guideline 403 in rats, the LD50 was determined to be > 6.1 mg/l after a treatment period of 4 hours. Acute dermal toxicity was assessed in a study similar to OECD test guideline 402, resulting in a LD50 > 4850 mg/kg body weight. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/949f0560-51f2-46a1-80b3-fb09e3fac507/documents/IUC5-c2fbc357-2a5c-4925-88a3-801112ef6a11_cb7c8ae0-4f7e-4e27-8aeb-a543a274ba4c.html,,,,,, 4-methylanisole,104-93-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/949f0560-51f2-46a1-80b3-fb09e3fac507/documents/IUC5-c2fbc357-2a5c-4925-88a3-801112ef6a11_cb7c8ae0-4f7e-4e27-8aeb-a543a274ba4c.html,,oral,LD50,"1,920 mg/kg bw",, p-cymene,99-87-6," One key Guideline OECD 422 study in rats is available for assessment. NOAEL (males): 50 mg/Kg/day (based on epididymal and testicular organ weights, testicular germ cell degeneration/depletion and/or sperm retention in the testes and epididymal luminal cell debris and reduced sperm and cribriform changes at 100 or 200 mg/Kg/day). NOAEL (females): 100 mg/Kg/day (based on alterations in oestrous cyclicity and morbidity at 200 mg/Kg/day). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b747e25-52b0-433c-84de-5c35f57dbc89/documents/a158c6ca-adda-4ee6-96b4-8df35c52353a_b787c312-4b5e-4b14-ab88-398252b36283.html,,,,,, p-cymene,99-87-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b747e25-52b0-433c-84de-5c35f57dbc89/documents/a158c6ca-adda-4ee6-96b4-8df35c52353a_b787c312-4b5e-4b14-ab88-398252b36283.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat p-cymene,99-87-6,"Acute oral toxicity In the key acute oral study of Jenner et al. (1964), groups of 10 male and 10 female Osborne-Mendel rats were orally administered undulitued p-Cymene at various doses (not specified) to calculate an oral LD50. Rats were monitored for up to 2 weeks. The death time for p-Cymen was indicated between 4 hr-2 weeks. Rats showed depression shortly following dosing. The coma, bloody lacrimation, diarrhea with irritable, scrawny appearance during were noted the observation period. The LD50 was calculated using the method of Litchfield & Wilcoxon (1949). LD50 was determined to be 4750 mg/kg bw (95% confidence limits: 3720-6060) with a slope function of 1.7.   Acute dermal toxicity In a study report of Moreno (1973), ten rabbits were dermally treated with p-Cymene at 5000 mg/kg bw. The animals were observed for any signs of toxicity and death for 14 days. All rabbits survived the treatment. No signs of toxicty were reported. Skin irritation was graded as follows: slight redness (3/10), moderate redness (7/10), slight edema (3/10), and moderate edema (7/10). Based on the results, the LD50 was estimated to be greater than 5000 mg/kg bw.   Acute inhalation toxicity In the unpublished reports of MacDonald (1962), rats, mice and guinea pigs were exposed to atmospheres saturated with 9.7 mg /L of p-Cymene for a period of 5 hours. Surviving animals were removed from the exposure chamber and observed for an additional week. No deaths were reported in guinea pigs or rats. All exposed mice died during or within 24 hours of exposure. The reported LC50 values were as follows: LC50 (guinea pig) > 9.7 mg/L; LC50 (rat) > 9.7 mg/L; and LC50 (mouse) < 9.7 mg/L. As the quality of the tests in these three species is comparable and it is unknown which species is the most relevant for humans, the most sensitive species was used for determination of the classification. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The LC50 was below 0.0097 mg/m³ air. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b747e25-52b0-433c-84de-5c35f57dbc89/documents/c3697da4-a84b-4a33-a797-1def261442b7_b787c312-4b5e-4b14-ab88-398252b36283.html,,,,,, p-cymene,99-87-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b747e25-52b0-433c-84de-5c35f57dbc89/documents/c3697da4-a84b-4a33-a797-1def261442b7_b787c312-4b5e-4b14-ab88-398252b36283.html,,oral,LD50,"4,750 mg/kg bw",adverse effect observed, p-cymene,99-87-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b747e25-52b0-433c-84de-5c35f57dbc89/documents/c3697da4-a84b-4a33-a797-1def261442b7_b787c312-4b5e-4b14-ab88-398252b36283.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, p-cymene,99-87-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b747e25-52b0-433c-84de-5c35f57dbc89/documents/c3697da4-a84b-4a33-a797-1def261442b7_b787c312-4b5e-4b14-ab88-398252b36283.html,,inhalation,discriminating conc.,< 0.01 mg/m3,adverse effect observed, Mequinol,150-76-5,"- Based on the OECD guideline 422 study performed in 2009, a NOAEL of 150 mg/kg bw/day and a LOAEL of 300 mg/kg bw/day were identified in rats for General effects.- In a weight of evidence approach using Hodge et al., 1949 publication (reliability 3) and carcinogenic data, PMP does not induce effect after dermal exposure.- No inhalation study is available. However, such study is not needed since PMP particle size is higher than 100 µm. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a2ab8b1-5404-4e8a-8095-005975030787/documents/IUC5-7e432e93-070c-4edb-8a58-2aa903261f53_ec18bb5e-670e-4ec4-a33d-f3da06fb7afa.html,,,,,, Mequinol,150-76-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a2ab8b1-5404-4e8a-8095-005975030787/documents/IUC5-7e432e93-070c-4edb-8a58-2aa903261f53_ec18bb5e-670e-4ec4-a33d-f3da06fb7afa.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Mequinol,150-76-5," Three non-reliable studies are available for the oral acute toxicity. The results of two studies are consistent with the official classification in Europe: Acute Tox. Cat.4, H302. No data are available for acute inhalation toxicity. However, such study is not required since PMP particle size is higher than 100 µm. One reliable study by dermal route is available. Based on this study the substance is not classified. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a2ab8b1-5404-4e8a-8095-005975030787/documents/IUC5-131643fb-5438-4f10-a579-b54ba9636a34_ec18bb5e-670e-4ec4-a33d-f3da06fb7afa.html,,,,,, Mequinol,150-76-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a2ab8b1-5404-4e8a-8095-005975030787/documents/IUC5-131643fb-5438-4f10-a579-b54ba9636a34_ec18bb5e-670e-4ec4-a33d-f3da06fb7afa.html,,oral,LD50,"1,630 mg/kg bw",adverse effect observed, p-phenetidine,156-43-4,Weight of evidence: Oral acute toxicity: data obtained from single administration in rats. LD50 = 580 mg/kg bw in rats.Oral acute toxicity: data obtained in rats. LD50 = 540 ± 34 mg/kg bw in rats and 600 ± 21 mg/kg bw in mice. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/563fbe77-1eb5-4b26-961c-36e69d01d39f/documents/IUC5-9b427759-546f-4af0-b089-aa08fa99ad30_66d5e8e5-bab9-4eb9-90b6-3e254875f98c.html,,,,,, "Benzene-1,4-diammonium sulphate",16245-77-5," Acute oral Toxicity:  In Acute oral toxicity,LDL0 value for target substance Benzene-1,4-diammonium sulphate (CAS no.: 16245-77-5) was considered to be 142.5 mg/kg bw and MLD value was considered to be 75 mg/kg bw,and for differentstudies available on structurally similar read across substance was considered to be 55 mg/kg bw. All these studies concluded that the LD50 value is between 50- 300 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Benzene-1,4-diammonium sulphate (CAS no.: 16245-77-5) can be classified as “Category III” for acute oral toxicity. Acute Inhalation Toxicity:  Benzene-1,4-diammonium sulphate (CAS no.: 16245-77-5)has very low vapour pressure (0.000413 Pa =3.097754308e-6 mmHg),So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver. Acute dermal Toxicity:  The acute dermal toxicity dose (LD50) for Benzene-1,4-diammonium sulphate (CAS no.: 16245-77-5) was based on data available for the structurally and functionally similar read across chemicals. The LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Benzene-1,4-diammonium sulphate (CAS no.: 16245-77-5) cannot be classified for acute dermal toxicity.  ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f099d6a6-7dde-4d57-9a5e-565f6eaaa6ee/documents/c24209bd-b8b2-46e0-9a27-2cb14909c358_a6468e4d-066a-48ff-935c-17dc6c531804.html,,,,,, "Benzene-1,4-diammonium sulphate",16245-77-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f099d6a6-7dde-4d57-9a5e-565f6eaaa6ee/documents/c24209bd-b8b2-46e0-9a27-2cb14909c358_a6468e4d-066a-48ff-935c-17dc6c531804.html,,oral,LD50,142.5 mg/kg bw,adverse effect observed, "Benzene-1,4-diammonium sulphate",16245-77-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f099d6a6-7dde-4d57-9a5e-565f6eaaa6ee/documents/c24209bd-b8b2-46e0-9a27-2cb14909c358_a6468e4d-066a-48ff-935c-17dc6c531804.html,,dermal,LD50,"4,000 mg/kg bw",no adverse effect observed, "Methyl 2-[[3-[4-(1,1-dimethylethyl)phenyl]-2-methylpropylidene]amino]benzoate",91-51-0, Acute oral toxicity: OECD TG 420: LD50 > 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49187b26-d50a-4629-85d2-57f093fb330b/documents/c7202782-052f-40ef-8bd8-6129bed5f16a_accf2674-553d-49cf-84a5-c3ef2991efd8.html,,,,,, "Methyl 2-[[3-[4-(1,1-dimethylethyl)phenyl]-2-methylpropylidene]amino]benzoate",91-51-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49187b26-d50a-4629-85d2-57f093fb330b/documents/c7202782-052f-40ef-8bd8-6129bed5f16a_accf2674-553d-49cf-84a5-c3ef2991efd8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, p-vinylphenol,2628-17-3," The toxic changes in this fourteen day study are similar to those of phenol (EC 203-632-7 CAS 108-95-2), corrosive and chemical burns at contact site, etc. Reference should be made to Agency for Toxic Substances and Disease Registry (USA) Medical Management Guidelines for Phenol mmg115 2017. The male animals who given the low dose of 50 mg/kg/bw were assessed as unlikley to be capable of reproduction. Due to the toxicity of the substance a toxicity ro reproduction study is going to be difficult to assess due to the other toxic effects of the substance on the animals. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c232db0d-743f-4cc5-a6fd-2d3eaf3f8cf7/documents/48d2b3b8-36ff-4dae-b44d-09fd7dc2ddd7_1f7aa4c6-8f72-4e37-a130-45df008f8748.html,,,,,, p-vinylphenol,2628-17-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c232db0d-743f-4cc5-a6fd-2d3eaf3f8cf7/documents/48d2b3b8-36ff-4dae-b44d-09fd7dc2ddd7_1f7aa4c6-8f72-4e37-a130-45df008f8748.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat p-vinylphenol,2628-17-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 1 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c232db0d-743f-4cc5-a6fd-2d3eaf3f8cf7/documents/daa09d19-534e-4258-a9a7-dcc6893ca9ad_1f7aa4c6-8f72-4e37-a130-45df008f8748.html,,,,,, p-vinylphenol,2628-17-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c232db0d-743f-4cc5-a6fd-2d3eaf3f8cf7/documents/daa09d19-534e-4258-a9a7-dcc6893ca9ad_1f7aa4c6-8f72-4e37-a130-45df008f8748.html,,oral,LD50,500 mg/kg bw,adverse effect observed, (hexadecylamidopropyl)trimethylammonium chloride,51277-96-4,"- Subacute (14 day dose-range finding study) repeated dose toxicity study oral (gavage), rat Crl:WI(Han)) m/f (similar to OECD TG 407, GLP), dose levels: 0, 50, 200, 500 mg/kg bw/d; no NOAEL derived (dose range finding study): all animals at 500 mg/kg bw/d were sacrificed for humane reasons; slight changes in haematology and clinical biochemistry at 50 and 200 mg/kg bw/d; read-across: Stearic acid 3 -(dimethylaminopropyl)amide - subacute (28 d study) repeated dose toxicity study oral (gavage), rat Sprague-Dawley m/f (similar to OECD TG 407), dose levels: 0, 30, 100 and 300 mg/kg bw/d (24-26% aqueous solution but it is not clear if the doses mentioned are corrected for undiluted test substance); NOAEL = 75 mg a.i./kg bw/day; read-across: Cetrimoniumchloride - subchronic (90 d study) repeated dose toxicity study oral (diet), rat Sprague-Dawley m/f (OECD TG 408), dose levels: 0, 100, 500 or 2,000 ppm, corresponding to 0, 22, 113 and 273 mg a.i./kg bw/day; NOAEL = 500 ppm (113 mg a.i./kg bw/d); read-across: C12-18 TMAC (Coco alkyl trimethyl ammonium chloride)   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2bca7a75-b789-405e-bd8d-5d879a83a249/documents/a2315b3e-a7f8-4a9a-9f50-00c333cbcc46_5034778e-6c4d-4c28-b023-cfa70c6250e9.html,,,,,, (hexadecylamidopropyl)trimethylammonium chloride,51277-96-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2bca7a75-b789-405e-bd8d-5d879a83a249/documents/a2315b3e-a7f8-4a9a-9f50-00c333cbcc46_5034778e-6c4d-4c28-b023-cfa70c6250e9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,113 mg/kg bw/day,,rat (hexadecylamidopropyl)trimethylammonium chloride,51277-96-4,"Acute oral toxicity: LD50 ca 699 mg/kg bw, OECD Guideline 401; RL1; GLP; read-across: Cetrimonium Chloride   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bca7a75-b789-405e-bd8d-5d879a83a249/documents/65c1584d-e821-416c-a277-1e95c212c63d_5034778e-6c4d-4c28-b023-cfa70c6250e9.html,,,,,, (hexadecylamidopropyl)trimethylammonium chloride,51277-96-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bca7a75-b789-405e-bd8d-5d879a83a249/documents/65c1584d-e821-416c-a277-1e95c212c63d_5034778e-6c4d-4c28-b023-cfa70c6250e9.html,,oral,LD50,ca.699 mg/kg bw,no adverse effect observed, Hexadecylamine,143-27-1," No test with the target substance is available. The three source substances are classified as STOT RE 2, H373 (may cause damage to organs through prolonged or repeated exposure; target organs: gastro-intestinal tract, liver, immune system). The target substance is classified as STOT RE 2, H373 (gastro-intestinal tract, liver, immune system) according to the precautionary principle. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e0bac68-aa74-4586-b139-15eaf56b4193/documents/3579403b-abeb-4d95-ab56-5a8312e0118b_767350fa-070e-44c5-9cbe-5f43c63906c7.html,,,,,, Hexadecylamine,143-27-1, The study does not need to be conducted because the substance is classified as skin corrosion Cat 1. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e0bac68-aa74-4586-b139-15eaf56b4193/documents/003bc6bd-26ae-4b5e-a472-2a7074ff98fd_767350fa-070e-44c5-9cbe-5f43c63906c7.html,,,,,, Palmitic acid,57-10-3,"Reliable studies on oral repeated dose toxicity are available for the following category members:Subchronic: NOAEL oral = ca. 5000 mg/kg bw/d; CAS# 143-07-7, C12 (Fitzhugh 1960)Subchronic: NOAEL oral = 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao 2002)No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3795ebbb-64fe-41e4-ba65-25eb9f4b1b02/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_4fc7568b-3052-4ab6-9fa2-e84774f44afa.html,,,,,, Palmitic acid,57-10-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3795ebbb-64fe-41e4-ba65-25eb9f4b1b02/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_4fc7568b-3052-4ab6-9fa2-e84774f44afa.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Palmitic acid,57-10-3,Acute toxicity:- oral: LD50 >5000 mg/kg bw (OECD 401);- inhalative: LC50 >0.1521 mg/L (IHT; Analogy CAS 124-07-2);- dermal: LD50 > 2000 mg/kg bw (Analogy CAS 57-11-4); ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3795ebbb-64fe-41e4-ba65-25eb9f4b1b02/documents/IUC5-7f3b5a6a-1c2d-433f-b7fb-b52ee919f950_4fc7568b-3052-4ab6-9fa2-e84774f44afa.html,,,,,, 2-(hexadecanoylamino)acetic acid,2441-41-0,"The LD50 of the test item LCA08002 is higher than 2000 mg/kg body weight by oral route in the rat. In accordance with the OECD guideline N°423, the LD50 of the test item may be considered higher than 5000 mg/kg body weight by oral route in the rat.According to the criteria for classification, packaging and labelling of dangerous substances and preparations in accordance with the E.E.C. Directives 67/548, 2001/59 and 99/45, the test item LCA08002 must not be classified. No symbol and risk phrases are required.In accordance with Globally harmonized System (COM(2007)355 final), the test item must not be classified in category 4. No signal word and hazard statement are required. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89279168-21b0-465c-b1cf-675c3744e5ea/documents/7bf5ec57-a1fc-4f8b-b420-5cd5b85714ab_509f7734-a5c7-4e3c-8877-b39edd1a2554.html,,,,,, 2-(hexadecanoylamino)acetic acid,2441-41-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89279168-21b0-465c-b1cf-675c3744e5ea/documents/7bf5ec57-a1fc-4f8b-b420-5cd5b85714ab_509f7734-a5c7-4e3c-8877-b39edd1a2554.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dexpanthenol,81-13-0,"A read across approach was performed with the supporting substance DL-Ethyl Panthenol. In a 90 day subchronic GLP and guideline study in rats, the test item showed a NOAEL of 1000 mg/kg bw/day, which was the highest dose tested. In addition oral exposure of rats for 28 days resulted in a NOAEL of 1000 mg/kg bw/day (highest dose tested). In a supporting subchronic oral toxicity study with DL- Panthenol the voluntary consumption of the test item by male and female rats in drinking water in the concentrations of 200, 50 and 20 mg/kg bw/day for a 90 day period showed essentially negative results. The no observed adverse effect level (NOAEL) under the conditions of this study was considered to be 200 mg/kg bw/day. In conclusion no adverse effects releated on D- Panthenol could be observed after oral exposure for 90 days. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4322592-3be9-46ac-8f67-ca8d7169209d/documents/IUC5-bb307692-7397-431d-b160-a6d00b4f8d7a_9349ce30-f547-471d-8f02-70863bec9792.html,,,,,, Dexpanthenol,81-13-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4322592-3be9-46ac-8f67-ca8d7169209d/documents/IUC5-bb307692-7397-431d-b160-a6d00b4f8d7a_9349ce30-f547-471d-8f02-70863bec9792.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dexpanthenol,81-13-0,The acute oral LD50 was determined to be > 10000 mg/kg bw. The acute dermal LD50 was determined to be > 2000 mg/kg bw. No signs of inhalation toxicity could be detected during a 7 h inhalation study with an atmosphere saturated with the test item. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4322592-3be9-46ac-8f67-ca8d7169209d/documents/IUC5-11ecbaa8-4230-436e-b9ed-7035374a8345_9349ce30-f547-471d-8f02-70863bec9792.html,,,,,, Dexpanthenol,81-13-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4322592-3be9-46ac-8f67-ca8d7169209d/documents/IUC5-11ecbaa8-4230-436e-b9ed-7035374a8345_9349ce30-f547-471d-8f02-70863bec9792.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, Dexpanthenol,81-13-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4322592-3be9-46ac-8f67-ca8d7169209d/documents/IUC5-11ecbaa8-4230-436e-b9ed-7035374a8345_9349ce30-f547-471d-8f02-70863bec9792.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Panthenol , DL-form",16485-10-2,"A read across approach was performed with the supporting substance DL-Ethyl Panthenol. In a 90 day subchronic GLP and guideline study in rats, the test item showed a NOAEL of 1000 mg/kg bw/day. In addition oral exposure of rats for 28 days resulted in a NOAEL of 1000 mg/kg bw/day. In a supporting subchronic oral toxicity study with DL- Panthenol the voluntary consumption of the test item by male and female rats in drinking water in the concentrations of 200, 50 and 20 mg/kg bw/day for a 90 day period showed essentially negative results. The no observed adverse effect level (NOAEL) under the conditions of this study was considered to be 200 mg/kg bw/day. In conclusion no adverse effects releated on DL- Panthenol could be observed after oral exposure for 90 days. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78e5721d-bff4-404f-97e1-044f0d644f7b/documents/IUC5-5170656d-3cc4-40e6-8ea7-c57fe34d1cd2_e1be92ae-da79-46b5-9cc8-3f82692caa43.html,,,,,, "Panthenol , DL-form",16485-10-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78e5721d-bff4-404f-97e1-044f0d644f7b/documents/IUC5-5170656d-3cc4-40e6-8ea7-c57fe34d1cd2_e1be92ae-da79-46b5-9cc8-3f82692caa43.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Panthenol , DL-form",16485-10-2,"For DL-Panthenol, no acute toxicity studies for oral and dermal toxicity were performed. A read across approach was performed with the structural similar substance DL-Ethyl Panthenol. DL-Ethyl Panthenol showed an acute oral LD50 greater than 2000 mg/KG bw in the rat. The dermal LD50 for DL-Ethyl Panthenol was found to be greater than 2000 mg/kg bw in the rat. Performance of an inhalation toxicity study was waived, as exposure via inhalation is not considered relevant, due to unlikely exposure via inhalation. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78e5721d-bff4-404f-97e1-044f0d644f7b/documents/IUC5-51dfeffe-dbe6-40e0-922b-bea4ab84aa0c_e1be92ae-da79-46b5-9cc8-3f82692caa43.html,,,,,, "Panthenol , DL-form",16485-10-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78e5721d-bff4-404f-97e1-044f0d644f7b/documents/IUC5-51dfeffe-dbe6-40e0-922b-bea4ab84aa0c_e1be92ae-da79-46b5-9cc8-3f82692caa43.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Panthenol , DL-form",16485-10-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78e5721d-bff4-404f-97e1-044f0d644f7b/documents/IUC5-51dfeffe-dbe6-40e0-922b-bea4ab84aa0c_e1be92ae-da79-46b5-9cc8-3f82692caa43.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Paraffin waxes and Hydrocarbon waxes,8002-74-2,"Paraffin and hydrocarbon waxes were found to be of low acute toxicity by the oral, and dermal routes.  There are no reports of acute inhalation toxicity studies of paraffin and hydrocarbon waxes; however, due to the very low vapour pressures of these substances, exposure by inhalation is not expected. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de2d1416-d5fd-4e0b-b9f9-7447ef25bba4/documents/f5fba283-f0eb-4023-9543-77f05d7e461b_bcfc6763-8489-45ef-89bb-23c2169e50bd.html,,,,,, Paraffin waxes and Hydrocarbon waxes,8002-74-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de2d1416-d5fd-4e0b-b9f9-7447ef25bba4/documents/f5fba283-f0eb-4023-9543-77f05d7e461b_bcfc6763-8489-45ef-89bb-23c2169e50bd.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rat Paraffin waxes and Hydrocarbon waxes,8002-74-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de2d1416-d5fd-4e0b-b9f9-7447ef25bba4/documents/f5fba283-f0eb-4023-9543-77f05d7e461b_bcfc6763-8489-45ef-89bb-23c2169e50bd.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,500 mg/kg bw/day",,rat Paraffin waxes and Hydrocarbon waxes,8002-74-2,The acute toxicity of paraffin and hydrocarbon waxes is low with no observed mortalities from oral (OECD 401/420) or dermal (OECD 402) applications. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de2d1416-d5fd-4e0b-b9f9-7447ef25bba4/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_bcfc6763-8489-45ef-89bb-23c2169e50bd.html,,,,,, Paraffin waxes and Hydrocarbon waxes,8002-74-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de2d1416-d5fd-4e0b-b9f9-7447ef25bba4/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_bcfc6763-8489-45ef-89bb-23c2169e50bd.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Paraffin waxes and Hydrocarbon waxes,8002-74-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de2d1416-d5fd-4e0b-b9f9-7447ef25bba4/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_bcfc6763-8489-45ef-89bb-23c2169e50bd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Paraffin waxes (petroleum), hydrotreated",64742-51-4,"Paraffin and hydrocarbon waxes were found to be of low acute toxicity by the oral, and dermal routes.  There are no reports of acute inhalation toxicity studies of paraffin and hydrocarbon waxes; however, due to the very low vapour pressures of these substances, exposure by inhalation is not expected. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33314b21-c7c8-44cb-8f09-025428d0f635/documents/f15719c3-410b-4c16-9d58-061adb431c23_b2e76770-1bae-49a4-8b39-ef85f854a84d.html,,,,,, "Paraffin waxes (petroleum), hydrotreated",64742-51-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33314b21-c7c8-44cb-8f09-025428d0f635/documents/f15719c3-410b-4c16-9d58-061adb431c23_b2e76770-1bae-49a4-8b39-ef85f854a84d.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rat "Paraffin waxes (petroleum), hydrotreated",64742-51-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33314b21-c7c8-44cb-8f09-025428d0f635/documents/f15719c3-410b-4c16-9d58-061adb431c23_b2e76770-1bae-49a4-8b39-ef85f854a84d.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,500 mg/kg bw/day",,rat "Paraffin waxes (petroleum), hydrotreated",64742-51-4,The acute toxicity of paraffin and hydrocarbon waxes is low with no observed mortalities from oral (OECD 401/420) or dermal (OECD 402) applications. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33314b21-c7c8-44cb-8f09-025428d0f635/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_b2e76770-1bae-49a4-8b39-ef85f854a84d.html,,,,,, "Paraffin waxes (petroleum), hydrotreated",64742-51-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33314b21-c7c8-44cb-8f09-025428d0f635/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_b2e76770-1bae-49a4-8b39-ef85f854a84d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Paraffin waxes (petroleum), hydrotreated",64742-51-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33314b21-c7c8-44cb-8f09-025428d0f635/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_b2e76770-1bae-49a4-8b39-ef85f854a84d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, White mineral oil (petroleum),8042-47-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c0d1b3b-ca78-4d9e-a027-da978c249163/documents/4f475de3-84ed-4ddc-b269-d9e83c3ed329_8e158f13-efa6-4c97-a7e4-8135f0ad5c97.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,50 mg/m3,,rat White mineral oil (petroleum),8042-47-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c0d1b3b-ca78-4d9e-a027-da978c249163/documents/4f475de3-84ed-4ddc-b269-d9e83c3ed329_8e158f13-efa6-4c97-a7e4-8135f0ad5c97.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rat White mineral oil (petroleum),8042-47-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c0d1b3b-ca78-4d9e-a027-da978c249163/documents/4f475de3-84ed-4ddc-b269-d9e83c3ed329_8e158f13-efa6-4c97-a7e4-8135f0ad5c97.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat White mineral oil (petroleum),8042-47-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c0d1b3b-ca78-4d9e-a027-da978c249163/documents/b38e5c7a-72a7-40d8-b40f-5d996000d9d5_8e158f13-efa6-4c97-a7e4-8135f0ad5c97.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, White mineral oil (petroleum),8042-47-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c0d1b3b-ca78-4d9e-a027-da978c249163/documents/b38e5c7a-72a7-40d8-b40f-5d996000d9d5_8e158f13-efa6-4c97-a7e4-8135f0ad5c97.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, White mineral oil (petroleum),8042-47-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c0d1b3b-ca78-4d9e-a027-da978c249163/documents/b38e5c7a-72a7-40d8-b40f-5d996000d9d5_8e158f13-efa6-4c97-a7e4-8135f0ad5c97.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Pidolic acid,98-79-3,"As there were no treatment related effects on systemic, reproduction and fertility parameters up to and including the highest dose tested 1000 mg/kg bwt/day, the No Observed Adverse Effect Level (NOAEL) for Combined Repeated Dose Toxicity Study with the  Reproduction/Developmental Toxicity Screening Test by Oral Gavage in Wistar rats for the test item Pidolic Acid is determined to be 1000 mg/kg bwt/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Sufficient to address requirements. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): Sufficient to address requirements. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Sufficient to address requirements. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f850dea-7eab-44bc-bc3e-9fb5e013180f/documents/236adc2a-2dce-4494-b15e-7af07d8eb287_bf3e3d61-93cd-4ba8-822a-ca0e6a45529c.html,,,,,, Pidolic acid,98-79-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f850dea-7eab-44bc-bc3e-9fb5e013180f/documents/236adc2a-2dce-4494-b15e-7af07d8eb287_bf3e3d61-93cd-4ba8-822a-ca0e6a45529c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Pidolic acid,98-79-3,"A study was performed to assess the acute oral toxicity of the substance in the Wistar strain rat at a dose of 2000 mg/kg bw. There were no deaths. There were no signs of systemic toxicity. All animals showed expected gains in body weight. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the substance in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw. A study was performed to assess the acute inhalation toxicity of the test item in the Wistar strain rat. A troup of ten rates (five males and five females) were exposed to a dust atmosphere (5mg/L) of the test item for 4 hours using a nose only exposure system, followed by a 14 or 35 days observation period. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths. The acute inhalation median lethal concentration (LC50) of the test item in the Wistar strain rat was estimated to be greater than 5.00 mg/L. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Sufficient to address requirements. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Sufficient to address requirements. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Sufficient to address requirements ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f850dea-7eab-44bc-bc3e-9fb5e013180f/documents/c5c64ec5-53e4-445e-91a6-e079d8cffae2_bf3e3d61-93cd-4ba8-822a-ca0e6a45529c.html,,,,,, Pidolic acid,98-79-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f850dea-7eab-44bc-bc3e-9fb5e013180f/documents/c5c64ec5-53e4-445e-91a6-e079d8cffae2_bf3e3d61-93cd-4ba8-822a-ca0e6a45529c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Pidolic acid,98-79-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f850dea-7eab-44bc-bc3e-9fb5e013180f/documents/c5c64ec5-53e4-445e-91a6-e079d8cffae2_bf3e3d61-93cd-4ba8-822a-ca0e6a45529c.html,,inhalation,LC50,> 5 mg/L,no adverse effect observed, "Dl-Proline, 5-oxo-, compd. with N2-coco acyl-l-arginine Et ester",95370-65-3," QSAR Predictions Toxicity of the target test material component 1 was predicted by T.E.S.T. using the Consensus method. The target chemical was predicted to have an LD50 of 2742 mg/kg bw. Toxicity of the target test material component 2 predicted by T.E.S.T. using the Consensus method. The target chemical was predicted to have an LD50 of 2106 mg/kg bw. The LD50 of both components was therefore predicted to be 2106 mg/kg bw. Supporting Study (Mihara, 2008) Under the conditions of the study, the LD50 was estimated to be greater than 3.0 g/kg body weight. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d4a1db6-c492-4d4f-91fa-e9f92bca2a30/documents/IUC5-da7b473e-c0a6-4356-80df-9e486fe7aa75_95b1afaa-4e82-410c-bd77-a910c0e37a03.html,,,,,, "Dl-Proline, 5-oxo-, compd. with N2-coco acyl-l-arginine Et ester",95370-65-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d4a1db6-c492-4d4f-91fa-e9f92bca2a30/documents/IUC5-da7b473e-c0a6-4356-80df-9e486fe7aa75_95b1afaa-4e82-410c-bd77-a910c0e37a03.html,,oral,LD50,"2,106 mg/kg bw",no adverse effect observed, "Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated",25322-68-3," Data available for the test chemical was reviewed to determine the toxic nature of the test chemical. The studies are as mentioned below:   Repeated dose toxicity: Oral   The study was designed to investigate the subacute repeated dose toxicity effects of the test chemical in Wistar rats (male/female) by oral route, in an overall study period of 90 days. Dose group (5 animals per group) was fed a solution of PEG400 equivalent to 0, 2000, 4000, 8000, 16000 or 24000 mg/kg/day in the diet. The control group received no test chemical. During the study period, body weight as a ratio to the amount of nutrient consumed, body weight, liver weight, kidney weight, micro pathology of liver and kidneys were examined. No effects upon male and female rats were observed when the test chemical was present in the diet at a level up to 8000 mg/kg/day (8%concentration) for 90 days study period. But at 16000 mg/kg/day it showed effects on organ weight (liver and kidney heavier than that of control rats);and a decrease in weight gain was observed. Thus, from overall conclusion of the study the NOAEL (no observed adverse effect level) for repeated dose oral toxicity was considered to be 8000 mg/kg/day. And the LOAEL (low observed adverse effect level) for subacute repeated dose toxicity was considered to be 16000 mg/kg/day.   Repeated dose toxicity: Inhalation   Rats were exposed to airborne concentrations of 100 mg/m3 and 1000 mg/m3 of test chemical for periods up to 13 weeks. Toxicological, physiological, hematological, blood chemical, and pathological effects were evaluated during the course of the exposures. No significant lesions observed in this study occurred exclusively in exposed animals and the severity of lesions which were found was not dose-related. The test chemical did not induced lesions in rat tissue at the dosage level and exposure/post exposure periods evaluated in this study. Organ:body weight ratios in rats at all concentrtions and for the 6- and 13-week exposure periods and the 30-day postexposure period showed no pattern of significance that could be related to test chemical. The organ:body weights for the 6-week·exposure period are unavailable. No pattern of significance could be related to test chemical exposure for the 13-week or the 30-day postexposure periods. The test chemical did not product any adverse physiological effects on the rats exposed to the 100 and 1000 mg/m 3 concentrations for the various exposure peri ods. This was not unexpected because the test chemical appear to present. There were no consistently 'significant changes in rat blood chemistry at the end of the 6- or 13-week exposures or the 30-day postexposure period. It appears that the test chemical produced no positive effects in the rodents at the 100 and 1000 mg/m3 test chemical concentrations over the 13 weeks of exposure used in this study. Thus it is concluded that the no observed adverse effect concentration (NOAEC) of the test chemical in rats was observed at dose level of 1000 mg/m3. Repeated dose toxicity: Dermal   The acute dermal toxicity value for Polyethylene glycol (CAS no 25322-68-3) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a96fb6da-bdb1-4dd7-9180-ced05f048b61/documents/2aa1058c-0027-4e03-abb0-7e6a1778bc48_f58bf82b-79bc-444d-bf69-f5a7d1b1042a.html,,,,,, "Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated",25322-68-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a96fb6da-bdb1-4dd7-9180-ced05f048b61/documents/2aa1058c-0027-4e03-abb0-7e6a1778bc48_f58bf82b-79bc-444d-bf69-f5a7d1b1042a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"8,000 mg/kg bw/day",,rat "Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated",25322-68-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a96fb6da-bdb1-4dd7-9180-ced05f048b61/documents/2aa1058c-0027-4e03-abb0-7e6a1778bc48_f58bf82b-79bc-444d-bf69-f5a7d1b1042a.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat "Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated",25322-68-3," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different experimental study report and other studies conducted on rats and mice for the test chemical. The LD50 value is >2000 mg/kg bw for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The study need not be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size.In accordance with column 2 of Annex VIII, this end point was considered for waiver since the vapour pressure of test chemical is low and so exposure by the inhalation route is unlikely. Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different experimental study reports conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a96fb6da-bdb1-4dd7-9180-ced05f048b61/documents/c5ff1272-7195-4c1b-badc-a350a66a37aa_f58bf82b-79bc-444d-bf69-f5a7d1b1042a.html,,,,,, "Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated",25322-68-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a96fb6da-bdb1-4dd7-9180-ced05f048b61/documents/c5ff1272-7195-4c1b-badc-a350a66a37aa_f58bf82b-79bc-444d-bf69-f5a7d1b1042a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Poly(oxy-1,2-ethanediyl),α-hydro-ω-hydroxy- Ethane-1,2-diol, ethoxylated",25322-68-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a96fb6da-bdb1-4dd7-9180-ced05f048b61/documents/c5ff1272-7195-4c1b-badc-a350a66a37aa_f58bf82b-79bc-444d-bf69-f5a7d1b1042a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Castor oil, ethoxylated",61791-12-6,"Data available for the target and structurally similar read across chemicals have been reviewed to determine the repeated dose toxicity of the test chemical. Repeated dose toxicity: Oral The oral administration of Castor oil, ethoxylated (PEG-40 Castor oil) to  rat ,at a dose level of 5000 mg/kg diet (5.0%).No effect observed on body weight ,feed intake, hematology as well as gross and histopathology. Thus the NOEL for repeated dose toxicity study was considered to be 5000 mg/kg diet (5.0%). Repeated dose toxicity: Inhalation This endpoint was considered for a waiver since according to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Considering the low vapor pressure (1.0E-33 Pa at 25deg ®C) of Castor oil, ethoxylated, exposure via the inhalation route is unlikely, this endpoint was considered for waiver. Repeated dose toxicity: Dermal The repeated dose toxicity of PEG-40 Hydrogenated Castor Oil was observed at a dose concentration of 2500 mg/kg bw/day as showed negative effects in body weight gain, behavior, hematology, urinalysis, or clinical chemistry and microscopic lesions in rat in 13 weeks sub-chronic study. Therefore, the NOAEL (No observed adverse effect level) for repeated dose toxicity was considered to be 2500 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2da59f6e-bccb-47f6-84b5-da54a97036ec/documents/d8d88b39-c839-4cdd-8800-1d26faf34e3e_f20f5761-4bb1-4253-b6f1-e2a64f6e1dd7.html,,,,,, "Castor oil, ethoxylated",61791-12-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2da59f6e-bccb-47f6-84b5-da54a97036ec/documents/d8d88b39-c839-4cdd-8800-1d26faf34e3e_f20f5761-4bb1-4253-b6f1-e2a64f6e1dd7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat "Castor oil, ethoxylated",61791-12-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2da59f6e-bccb-47f6-84b5-da54a97036ec/documents/d8d88b39-c839-4cdd-8800-1d26faf34e3e_f20f5761-4bb1-4253-b6f1-e2a64f6e1dd7.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,500 mg/kg bw/day",,rat "Castor oil, ethoxylated",61791-12-6,"Acute oral toxicity:    Acute oral toxicity dose (LD50) of the test chemical was considered based on experimental study conducted on mice, the LD50 value was considered to be 6500 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.   Acute Inhalation toxicity:    the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size   Acute Dermal Toxicity:   Acute Dermal toxicity dose (LD50) for the test chemical was considered based on experimental study conducted on rats, the value was considered to be >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2da59f6e-bccb-47f6-84b5-da54a97036ec/documents/4e170bfb-d953-49c0-b4fc-0377bf2d7c4a_f20f5761-4bb1-4253-b6f1-e2a64f6e1dd7.html,,,,,, "Castor oil, ethoxylated",61791-12-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2da59f6e-bccb-47f6-84b5-da54a97036ec/documents/4e170bfb-d953-49c0-b4fc-0377bf2d7c4a_f20f5761-4bb1-4253-b6f1-e2a64f6e1dd7.html,,oral,LD50,"6,500 mg/kg bw",no adverse effect observed, "Castor oil, ethoxylated",61791-12-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2da59f6e-bccb-47f6-84b5-da54a97036ec/documents/4e170bfb-d953-49c0-b4fc-0377bf2d7c4a_f20f5761-4bb1-4253-b6f1-e2a64f6e1dd7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "(Z)-Octadec-9-enylamine, ethoxylated",26635-93-8,"There is 28 Day oral dosing study available for 2, 2’-(Octadec-9-enylimino) bisethanol CAS No 25307-17-9, dose level where 250mg/kg/day reduced to 150mg/kg/day , 100mg/kd/day and 30 mg/kg/day.  The no-observed-adverse-effect-level (NOAEL), is regarded as 30 mg/kg/day.  This study has now been followed by an OECD408 90 day oral (gavage) dosing study in rats.  This study which used dose levels of 5, 30 and 150 mg/kg bodyweight, confirmed a 30mg/kg NOAEL despite the longer duration of dosing. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/06e52ff6-2827-438d-aebf-da271584dac5/documents/5e2ea788-e0b1-4486-8a10-1b9003e7349f_dffefa83-7bc8-48af-a709-816862d1734a.html,,,,,, "(Z)-Octadec-9-enylamine, ethoxylated",26635-93-8,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/06e52ff6-2827-438d-aebf-da271584dac5/documents/5e2ea788-e0b1-4486-8a10-1b9003e7349f_dffefa83-7bc8-48af-a709-816862d1734a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "(Z)-Octadec-9-enylamine, ethoxylated",26635-93-8,"The only study available is an oral LD50 study on 2,2'-(Octadec-9-enylimino)bisethanol  CAS No 25307-17-9, the study is reliability 1 GLP compliant to OECD Guideline 410. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06e52ff6-2827-438d-aebf-da271584dac5/documents/de08961a-7322-4a3c-9b3d-952bb49ea570_dffefa83-7bc8-48af-a709-816862d1734a.html,,,,,, "(Z)-Octadec-9-enylamine, ethoxylated",26635-93-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06e52ff6-2827-438d-aebf-da271584dac5/documents/de08961a-7322-4a3c-9b3d-952bb49ea570_dffefa83-7bc8-48af-a709-816862d1734a.html,,oral,LD50,"1,260 mg/kg bw",, "Sorbitan monolaurate, ethoxylated",9005-64-5,"Oral: based on a weight of evidence approach, all oral repeated dose toxicity studies for the test substance revealed no adverse effects. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e0e605f-c268-47d9-b712-611da59aae16/documents/IUC5-55d652ff-4e7c-43d3-babd-5507f540d2d4_4c27a860-8d17-409d-a88a-adcc3302371b.html,,,,,, "Sorbitan monolaurate, ethoxylated",9005-64-5,"Acute toxicity:Oral: based on a weight of evidence approach, all available acute oral toxicity studies on the test substance resulted in acute oral LD50 in rats greater than 2000 mg/kg bw.Inhalation (OECD 403), rat, 4 hour exposure: LD50 > 5.1 mg/LDermal: no study available ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e0e605f-c268-47d9-b712-611da59aae16/documents/IUC5-54aab122-bac6-418c-a431-6cb592f78976_4c27a860-8d17-409d-a88a-adcc3302371b.html,,,,,, "Fatty acids, tall-oil, ethoxylated",61791-00-2," Under the conditions of this Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, the oral administration by gavage of test substance to Wistar rats revealed no adverse signs of toxicity in male and female animals at a dose level of 1000 mg/kg bw/d. Thus, the no observed adverse effect level (NOAEL) for general systemic toxicity was 1000 mg/kg bw/d for male and female Wistar rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2541909d-a907-4504-89e5-6eb01eed2482/documents/658fbc01-e2d8-4a34-b32c-7849a87568fb_4c640afd-d456-4727-91e8-5ee31012fc4f.html,,,,,, "Fatty acids, tall-oil, ethoxylated",61791-00-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2541909d-a907-4504-89e5-6eb01eed2482/documents/658fbc01-e2d8-4a34-b32c-7849a87568fb_4c640afd-d456-4727-91e8-5ee31012fc4f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, tall-oil, ethoxylated",61791-00-2, The acute oral LD50 of the test substance was determined to be > 10000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2541909d-a907-4504-89e5-6eb01eed2482/documents/013eced2-c2f8-4cd9-ae87-d7137fed8c99_4c640afd-d456-4727-91e8-5ee31012fc4f.html,,,,,, "Fatty acids, tall-oil, ethoxylated",61791-00-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2541909d-a907-4504-89e5-6eb01eed2482/documents/013eced2-c2f8-4cd9-ae87-d7137fed8c99_4c640afd-d456-4727-91e8-5ee31012fc4f.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, ethoxylated",61791-00-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2541909d-a907-4504-89e5-6eb01eed2482/documents/013eced2-c2f8-4cd9-ae87-d7137fed8c99_4c640afd-d456-4727-91e8-5ee31012fc4f.html,,inhalation,discriminating conc.,340 mg/m3,no adverse effect observed, "Propylidynetrimethanol, ethoxylated, esters with acrylic acid",28961-43-5,"Oral: OECD 422: Wistar Han rats were treated with Propylidynetrimethanol, ethoxylated, esters with acrylic acid (TMPeoTA) by daily oral gavage at dose levels of 100, 300 and 1000 mg/kg/day in a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, in accordance to OECD 422. The rats of the control group received the vehicle, corn oil, alone. Males were treated for 2 weeks prior to mating, during mating, and up to termination (for 29 days). Females that delivered offspring were treated for 2 weeks prior to mating, during mating, during post-coitum, and at least 13-15 days of lactation (for 51-55 days (most females) or 63 days (one Group 3 female)). Females which did not mate or failed to deliver were treated for 52 days or 42 days, respectively. Based on the results, the following No Observed Adverse Effect Levels (NOAEL) for Propylidynetrimethanol, ethoxylated, esters with acrylic acid (TMPeoTA) were established: Parental (systemic) NOAEL: 1000 mg/kg/day Parental (local) NOAEL: 100 mg/kg/day   OECD 408: The administration of the read-across substance (GPTA) - Glycerol, propoxylated, esters with acrylic acid (CAS 52408-84-1) by daily oral gavage according to OECD TG 408 at dose levels of 50, 150 and 375 mg/kg bw/day was well tolerated in rats at levels up to 150 mg/kg bw/day (ReachCentrum, 2020). At 375 mg/kg bw/day adverse findings were noted in the forestomach only. These findings are consistent with a response to an irritant material. Based on these results, the following was concluded: Parental (systemic): 375 mg/kg bw/day Parental (local): 150 mg/kg bw/day   In addition,GPTA was tested in a Combined 28-Day Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to OECD TG 422 and in compliance with GLP (ReachCentrum, 2019). Wistar Han rats were treated by daily oral gavage at dose levels of 150, 375 and 750 mg/kg bw/day. Microscopic evaluation showed local alterations of the forestomach starting at 150 mg/kg bw/day in males (non-adverse) and at 375 mg/kg bw/day in females. In addition, ulcers which were degenerative in nature were noted in males at 375 mg/kg bw/day and at 750 mg/kg bw/day (in both males and females). At 750 mg/kg bw/day, two males and two females were sacrificed in extremis and one female was found dead. The systemic NOAEL is 375 mg/kg bw/day, based on treatment related mortality at 750 mg/kg bw/day. The local NOAEL is 150 mg/kg bw/day, based on adverse local forestomach effects at 375 mg/kg bw/day (males) and 750 mg/kg bw/day (both sexes). Parental (systemic) NOAEL: 375 mg/kg/day Parental (local) NOAEL: 150 mg/kg/day,   Dermal: No data available. Supportive data available from a carcinogenicity, mice, dermal, 94 weeks (2 times/week/25µL 10% v/v acetone): not carcinogenic, no systemic effects NOAEL ≥ 19.5 mg/kg bw/d (Cytec, Kettering Laboratory, 1987) but less reliable as performed with an outdated protocol (Klimisch score 3).     Inhalation: No data available   For DNEL derivation, a NOAEL of 375 mg/kg bw/day from the OECD 408 study using GPTA (read-across substance) is used. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): One OECD 422 study performed in accordance to GLP available for TMPeoTA (CAS 28961-43-5) One OECD 408 study performed in accordance to GLP available for the read-across substance GPTA (CAS 52408-84-1) - read-across substance One OECD 422 study performed in accordance to GLP available for the read-across substance GPTA (CAS 52408-84-1) - read-across substance ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7bed3ad1-6c5c-4be3-a0ee-53ad929acfbc/documents/2a34136e-8bae-4e4f-983c-f862f5bb7248_d335607c-21c4-4a35-ae46-3abb694ebb18.html,,,,,, "Propylidynetrimethanol, ethoxylated, esters with acrylic acid",28961-43-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7bed3ad1-6c5c-4be3-a0ee-53ad929acfbc/documents/2a34136e-8bae-4e4f-983c-f862f5bb7248_d335607c-21c4-4a35-ae46-3abb694ebb18.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,375 mg/kg bw/day,,rat "Propylidynetrimethanol, ethoxylated, esters with acrylic acid",28961-43-5,"Oral: acute toxicity, oral, rat, OECD 401, LD50 > 2000 mg/kg bw (Cray Valley, Huntingdon, 1998) acute toxicity, oral, rat, similar OECD 401, LD50 > 2000 mg/kg bw (BASF, 1991). acute toxicity, oral, rat, similar OECD 401, LD50 > 5000 mg/kg bw (Cognis, Food and Drug research laboratories, 1985). acute toxicity, oral, rat, protocol not specified, LD50 > 500 mg/kg bw but ≤ 5000 mg/kg bw, note: 2000 mg/kg was not assessed (Cytec, Bio/Dynamics, 1984).   Dermal: acute toxicity, dermal, rabbit, protocol not specified, LD50 > >13200 mg/kg bw (Cytec, Bio/Dynamics, 1984)   Inhalation: No information on acute inhalation available for TMPeoTA. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): There are a few studies available assessing the acute oral toxicity. All studies result point to the same result, but only one study is conducted according to OECD guideline under GLP (Cray Valley, Huntingdon, 1998, McRae L.A.). As this study is also the latest conducted and very well documented study this study is assigned as key study. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): One key study available (Klimisch scoe 2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bed3ad1-6c5c-4be3-a0ee-53ad929acfbc/documents/b57b5920-c4cd-4763-b4c7-6f500cb560b2_d335607c-21c4-4a35-ae46-3abb694ebb18.html,,,,,, "Propylidynetrimethanol, ethoxylated, esters with acrylic acid",28961-43-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bed3ad1-6c5c-4be3-a0ee-53ad929acfbc/documents/b57b5920-c4cd-4763-b4c7-6f500cb560b2_d335607c-21c4-4a35-ae46-3abb694ebb18.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Propylidynetrimethanol, ethoxylated, esters with acrylic acid",28961-43-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bed3ad1-6c5c-4be3-a0ee-53ad929acfbc/documents/b57b5920-c4cd-4763-b4c7-6f500cb560b2_d335607c-21c4-4a35-ae46-3abb694ebb18.html,,dermal,LD50,"13,200 mg/kg bw",no adverse effect observed, "2,2'-(octylimino)bisethanol",15520-05-5," OECD 408 -90 day repeated dose toxicity: Oral administration of Genamin 3920 [2,2’-(Octylimino)bisethanol] for 90 consecutive days followed by 28 days of recovery period was found to be well tolerated in Wistar rats up to 350 mg/kg b.w./day without any obvious signs of toxicity. On the basis of the study findings, the No Observed Adverse Effect Level (NOAEL) of Genamin 3920 [2,2’-(Octylimino)bisethanol] following 90-day repeated dose Oral administration in Wistar rats was 350 mg/kg b.w./day under the tested conditions. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d5f98700-7b9e-4d14-a9da-4db700a61bfe/documents/e8942a28-9ed1-4424-8a36-798faa069d48_9f69790a-a1d3-4132-be5e-6c89c09d69d7.html,,,,,, "2,2'-(octylimino)bisethanol",15520-05-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d5f98700-7b9e-4d14-a9da-4db700a61bfe/documents/e8942a28-9ed1-4424-8a36-798faa069d48_9f69790a-a1d3-4132-be5e-6c89c09d69d7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,350 mg/kg bw/day,,rat "2,2'-(octylimino)bisethanol",15520-05-5,After single oral application the LD 50 in female rats was determined as 1157 mg/kg bw. After single dermal exposure to 2000 mg/kg bw no mortality or other systemic effects were observed. Local irritation occurred at the site of application. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5f98700-7b9e-4d14-a9da-4db700a61bfe/documents/ef6b98d3-a10b-4c01-9c7c-09e56e2e0094_9f69790a-a1d3-4132-be5e-6c89c09d69d7.html,,,,,, "2,2'-(octylimino)bisethanol",15520-05-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5f98700-7b9e-4d14-a9da-4db700a61bfe/documents/ef6b98d3-a10b-4c01-9c7c-09e56e2e0094_9f69790a-a1d3-4132-be5e-6c89c09d69d7.html,,oral,LD50,"1,157 mg/kg bw",adverse effect observed, "2,2'-(octylimino)bisethanol",15520-05-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5f98700-7b9e-4d14-a9da-4db700a61bfe/documents/ef6b98d3-a10b-4c01-9c7c-09e56e2e0094_9f69790a-a1d3-4132-be5e-6c89c09d69d7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Poly(oxy-1,2-ethanediyl), alpha-[2-[bis(2-aminoethyl)methylammonion)ethyl]-, omega-hydroxy, N,N'-di-Limnanthes alba seed oil acyl derivatives, methyl sulfates (salts)",226995-92-2, In a reliable acute toxicity study the substance was administered to Wistar rats (10 animals/dose) by oral gavage at a dose level of 5000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity during the 14 day observation period.The oral LD50 is >5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c0fc7cb-0df7-44a7-afb7-be08bf013b49/documents/50c511b3-3221-4188-861a-cb398023dced_ce8cb716-eb92-44cd-94f0-9659ae01287a.html,,,,,, "Poly(oxy-1,2-ethanediyl), alpha-[2-[bis(2-aminoethyl)methylammonion)ethyl]-, omega-hydroxy, N,N'-di-Limnanthes alba seed oil acyl derivatives, methyl sulfates (salts)",226995-92-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c0fc7cb-0df7-44a7-afb7-be08bf013b49/documents/50c511b3-3221-4188-861a-cb398023dced_ce8cb716-eb92-44cd-94f0-9659ae01287a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,2'-(octadec-9-enylimino)bisethanol",25307-17-9," There is 28 Day oral dosing study available for 2, 2’-(Octadec-9-enylimino) bisethanol CAS No 25307-17-9, with dose levels of 250, reduced to 150 from day 9, 100 and 30 mg/kg/day. This resulted to mainly local irritant effects in the stomach, small intestines and foamy macrophages in the mesenteric lymph nodes from 100 mg. The NOAEL was 30 mg/kg, based on gastric changes detected in one male and one female treated with 30 mg/kg/day considered to be adverse. This study has been followed by a 90-day oral (gavage) study in rats (OECD 408) with dose levels of 5, 30 and 150 mg/kg/day. Changes considered to be associated with the administration of the test item were present in the non-glandular stomach of animals given 30 or 150 mg/kg bw/day and the small intestine (duodenum, jejunum and ileum) and mesenteric lymph nodes of animals given 150 mg/kg bw/day. No treatment-related findings were observed in animals given 5 mg/kg bw/day. Based on microscopic changes restricted to the fore stomach at 30 mg, representing a local irritancy effect of the test item rather than systemic toxicity, the overall NOEL was established at 5 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/904ecd14-1d33-4ffe-9b3e-79db4bf30278/documents/2122581b-7246-4ac4-9518-adf8efa741a7_31d23284-eb12-4b7b-93b0-a4edde21cf7f.html,,,,,, "2,2'-(octadec-9-enylimino)bisethanol",25307-17-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/904ecd14-1d33-4ffe-9b3e-79db4bf30278/documents/2122581b-7246-4ac4-9518-adf8efa741a7_31d23284-eb12-4b7b-93b0-a4edde21cf7f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "2,2'-(octadec-9-enylimino)bisethanol",25307-17-9," LD50 = 1260 mg/kg bw. The only study available is an oral LD50 study on 2,2'-(Octadec-9-enylimino)bisethanol  CAS No 25307-17-9, the study is reliability 1 GLP compliant to OECD Guideline 401. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/904ecd14-1d33-4ffe-9b3e-79db4bf30278/documents/d652e775-d436-4917-a3a7-8e3089df407f_31d23284-eb12-4b7b-93b0-a4edde21cf7f.html,,,,,, "2,2'-(octadec-9-enylimino)bisethanol",25307-17-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/904ecd14-1d33-4ffe-9b3e-79db4bf30278/documents/d652e775-d436-4917-a3a7-8e3089df407f_31d23284-eb12-4b7b-93b0-a4edde21cf7f.html,,oral,LD50,"1,260 mg/kg bw",adverse effect observed, Bis(hydroxyethyl)methyloleylammonium chloride,18448-65-2," Repeated dose toxicity: oral The repeated dose toxicity of the test substance, Quaternary ammonium compounds, coco alkylbis(hydroxyethyl)methyl chlorides, CAS Number 70750-47-9, EC Number 274-846-6, [Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808 -53 -2, EC Number 276 -038 -9], was investigated in a study conducted according to OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) / OPPTS 870.3650. This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across. The study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997). Under the conditions of thus study the general NOAEL was determined to be 25 mg/kg body weight/day for this substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8f53227-95fc-4c22-8cb7-c9175e4643f6/documents/c2231313-061a-44e7-ae5f-b271e6025852_fecae87c-9c73-4868-8226-1c909ff4cdfb.html,,,,,, Bis(hydroxyethyl)methyloleylammonium chloride,18448-65-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8f53227-95fc-4c22-8cb7-c9175e4643f6/documents/c2231313-061a-44e7-ae5f-b271e6025852_fecae87c-9c73-4868-8226-1c909ff4cdfb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Bis(hydroxyethyl)methyloleylammonium chloride,18448-65-2," Acute Toxicity: Oral The acute oral toxicity of the test substance, Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808 -53 -2, EC Number 276 -038 -9, was investigated in a study conducted according to theConsumer Product Safety Commission 16 CFR 1500. This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across. The study was assigned a reliability score of 2 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997). Under the conditions of the study the LD50 was determined to be 1710 mg/kg bw and, as a consequence, the substance is classified as a Category 4, harmful if swallowed according to the GHS criterial ( Regulation [EC] No 1272/2008 of the European Parliament and of the Council of 16 December 2008). Acute Toxicity: Inhalation Waiver Acute toxicity: Dermal The acute dermal toxicity of the test substance, Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides, CAS Number 71808 -53 -2, EC Number 276 -038 -9, was investigated in a study for which no guideline is available and details of the study design and results are noted to be inadequate. This substance is considered to be close enough in structural integrity to the target substance, bis(2 -hydroxyethyl)oleylmethylammonium chloride, CAS Number 18448 -65 -2, EC Number 242 -332 -0, so as to justify valid read-across. The study was assigned a reliability score of 3 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997). Under the conditions of the study the dermal LD50 was determined to be < 2500 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8f53227-95fc-4c22-8cb7-c9175e4643f6/documents/630ed7c9-588e-4c6f-8361-e288c8b3edf0_fecae87c-9c73-4868-8226-1c909ff4cdfb.html,,,,,, Bis(hydroxyethyl)methyloleylammonium chloride,18448-65-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8f53227-95fc-4c22-8cb7-c9175e4643f6/documents/630ed7c9-588e-4c6f-8361-e288c8b3edf0_fecae87c-9c73-4868-8226-1c909ff4cdfb.html,,oral,LD50,"1,710 mg/kg bw",adverse effect observed, Bis(hydroxyethyl)methyloleylammonium chloride,18448-65-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8f53227-95fc-4c22-8cb7-c9175e4643f6/documents/630ed7c9-588e-4c6f-8361-e288c8b3edf0_fecae87c-9c73-4868-8226-1c909ff4cdfb.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, 2-(2-phenoxyethoxy)ethanol,104-68-7," An OECD 422 repeated dose/reproductive screening study using Di-EPh; Several repeated dose oral, inhalation and dermal toxicity studies have been performed using phenoxyethanol (PE). The benchmark dose method was used to derive a BMDL10. The most critical effect was determined to be the renal hyperplasia in male rats. Combining the subchronic and chronic studies in rats a BMDL10 of 369 mg/kg bw/day has been derived. In a 90 -day repeated-dose dermal toxicity study in white rabbits toxicologically non relevant effects were observed. Therefore the highest dose tested (500mg/kg bw/day) was designated as the NOAEL for systemic toxicity. In a 14 -day inhalation study with rats pathological examinations revealed no treatment-related changes in either males or females. Morphological changes indicating irritation were found in nasal cavity, larynx, and lung of male and female mid- and high-concentration animals. A NOAEC of 48.2 mg/m3 was determined. The values being used for CSA have been corrected for the molecular weight difference between the target (Di-EPh) and source (EPh) chemicals (182.2/138.2) = 1.32 molecular weight correction factor. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97658999-3c6c-4f4b-b385-e8640c2b196b/documents/IUC5-7b0e6f49-a982-4070-8818-dcf38c296985_0fa607f3-4f20-44e6-a3d8-1fe53662cc15.html,,,,,, 2-(2-phenoxyethoxy)ethanol,104-68-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97658999-3c6c-4f4b-b385-e8640c2b196b/documents/IUC5-7b0e6f49-a982-4070-8818-dcf38c296985_0fa607f3-4f20-44e6-a3d8-1fe53662cc15.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,659.2 mg/kg bw/day,,rabbit 2-(2-phenoxyethoxy)ethanol,104-68-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97658999-3c6c-4f4b-b385-e8640c2b196b/documents/IUC5-7b0e6f49-a982-4070-8818-dcf38c296985_0fa607f3-4f20-44e6-a3d8-1fe53662cc15.html,Chronic toxicity – systemic effects,oral,BMDL10,486.5 mg/kg bw/day,,rat 2-(2-phenoxyethoxy)ethanol,104-68-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97658999-3c6c-4f4b-b385-e8640c2b196b/documents/IUC5-7b0e6f49-a982-4070-8818-dcf38c296985_0fa607f3-4f20-44e6-a3d8-1fe53662cc15.html,Repeated dose toxicity – local effects,inhalation,NOAEC,63.6 mg/m3,adverse effect observed,rat 2-(2-phenoxyethoxy)ethanol,104-68-7,"2 current guideline, reliability 1 studies for acute oral toxicity and dermal toxicity, 3 supporting studies for oral, dermal and inhalation and supporting data on the analogue phenoxy ethanol ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97658999-3c6c-4f4b-b385-e8640c2b196b/documents/IUC5-815f530a-601c-426f-bcfc-c072961e20e7_0fa607f3-4f20-44e6-a3d8-1fe53662cc15.html,,,,,, 2-(2-phenoxyethoxy)ethanol,104-68-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97658999-3c6c-4f4b-b385-e8640c2b196b/documents/IUC5-815f530a-601c-426f-bcfc-c072961e20e7_0fa607f3-4f20-44e6-a3d8-1fe53662cc15.html,,oral,LD50,"3,526 mg/kg bw",no adverse effect observed, "2,2'-(octadecylimino)bisethanol",10213-78-2,"There are two 90 day studies available, for the read across substance registered under 2,2’-(C16-18 (even numbered, C18 unsaturated) alkyl imino) diethanol CAS No 1218787-32-6. As this contain C18 unsaturated which is more reactive than the C18 saturated in 2,2’-(Octadecylimino)bisethanol) CAS No 10213-78-2 and C16, so it is expected to more toxic and therefore will not underestimate the toxicity of 2,2’-(Octadecylimino)bisethanol.  While these studies are from 1965 and less detailed than current studies, they are considered to be Klimisch 2.  Due to problems with vomiting in the dog study the rat study provides the most reliable repeat dose NOAEL at 35 mg/kg bw/day.   90-day study on 2,2'-(octadec-9-enylimino)bisethanol CAS No. 25307-17-9 (Klemish 1) included as a supporting study on the basis of structural similarity and increased insight into observed effects in the aforementioned studies. It is included to assist in the clarification of NOAEL of local effects on the gastrointestinal tract for 2,2'-(octadecylimino)bisethanol CAS No. 10213-78-2 for which there is adequate studies and information available. This study also helps to address local gastrointestinal effects seen in the EOGRTS for 2,2'-(octadec-9-enylimino)bisethanol CAS No. 25307-17-9. 2,2'-(octadec-9-enylimino)bisethanol Presents a worse case scenario based off structure as well as better defining local gastrointestinal effects. It is therefore proposed that the NOAEL of 30 mg/kg bw/day be used for overall hazard assessment. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): There are two 90 day studies available, for the read across substance registered under 2,2’-(C16-18 (even numbered, C18 unsaturated) alkyl imino) diethanol CAS No 1218787-32-6. While these studies are from 1965 and less detailed than current studies, they are considered to be Klimisch 2. Due to problems with vomiting in the dog study the rat study provides the most reliable repeat dose NOAEL. A 90-day study on 2,2'-(octadec-9-enylimino)bisethanol CAS No. 25307-17-9 included as a supporting study on the basis of structural similarity and increased insight into observed effects in the aforementioned studies. It is included to assist in the clarification of NOAEL of local effects on the gastrointestinal tract for 2,2'-(octadecylimino)bisethanol CAS No. 10213-78-2 for which there is adequate studies and information available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c4a72e3-8714-438d-9184-57c15f4d99f4/documents/IUC5-4753a345-b1a0-49ce-b3a0-72f201eb2528_90e8e0c0-ebbd-4199-840c-cccbf56ff157.html,,,,,, "2,2'-(octadecylimino)bisethanol",10213-78-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c4a72e3-8714-438d-9184-57c15f4d99f4/documents/IUC5-4753a345-b1a0-49ce-b3a0-72f201eb2528_90e8e0c0-ebbd-4199-840c-cccbf56ff157.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "2,2'-(octadecylimino)bisethanol",10213-78-2,"The only available study is read across to the oral LD50 study on 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol (tested under CAS No 90367-28-5) which shows LD50 to be >2000 mg/kg.  As 2,2’-(Octadecylimino)bisethanol) is a skin irritant but not corrosive, dermal absorption would be expected to be lower than oral, so the LD50 would also be expected to be > 2000mg/kg.  There is no study for an inhalation LC50, but the physical form of the substance as a waxy solid at ambient temperatures and its low vapour pressure mean that an inhalation LC50 study is not scientifically justified as inhalation exposure is not anticipated. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c4a72e3-8714-438d-9184-57c15f4d99f4/documents/IUC5-20702dc6-838f-419f-9ea9-b864f6560f48_90e8e0c0-ebbd-4199-840c-cccbf56ff157.html,,,,,, "Sorbitan monostearate, ethoxylated",9005-67-8," Repeated dose toxicity: Oral Repeated dose oral toxicity study was performed to determine the toxic nature of the test chemical. The study was performed using Osborne Mendel rats. The test chemical was mixed with feed at dose level of0, 2, 5, 10, and 25% (0, 1000, 2500, 5000 or 12500 mg/Kg/day) for 2 years. During the study, the animals were observed for mortality, morbidity, clinical signs, boody weight and organ weight changes, hematology, gross pathology and histopathology. Survival was unaltered by chemical treatment. Diarrhea was apparent throughout life in rats fed the test chemical, severe at 25%, moderate at 10%, and slight at 5%. No diarrhea was notes at 2% dose level. Average weight gain was calculated after 12 weeks on the diets to measure the effect on the early and rapid growth, and again after one year on the diet. Significant growth depression occurred in some groups at the 25% feeding level but in none at 10% or below. Adverse effects were more pronounced in males than in females. The inferior weight gain shown by male rats on the test chemical was statistically significant only at the 12-week period. Early growth depression in males fed 25% of the test chemical was accompanied by reduced food efficiency. Hematology studies showed normal values for hemoglobin, red and white blood cells, and differential counts for all groups. Most animals on the highest emulsifier dosage had livers which were enlarged and more friable than normal. No significant liver enlargement occurred in rats at lower dosages. With the test chemical treatment, cecal enlargement was moderate at the 25% level and to a lesser degree at the 10% level. The increased size of the cecum was obvious at autopsy and the weight of the wall also proved to be greater for the test animals (mean of four representative ceca at the 25% level was 5.29 g) than for the controls (mean 3.59 g). Increased hepatic cell vacuolation at 25% was less-not enough to be a distinct difference. With the test chemical, the enlarged ceca were normal microscopically. Based on the observations made, the no observed adverse effect level (NOAEL) for the test chemical is considered to be 1000 mg/Kg/day when male and female rats were exposed for 2 years. Repeated dose toxicty: Inhalation Sorbitan monostearate, ethoxylated (CAS no 9005-67-8) has very low vapor pressure (1.919E-18 Paat 25˚C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver Repeated dose toxicity: Dermal The acute dermal toxicity value forSorbitan monostearate, ethoxylated (CAS no 9005-67-8) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43d1be44-7b37-43c8-b5e1-e1aad6413c32/documents/4a9b0ca0-b149-4aa0-af5e-164b35337181_a23c31d3-5c68-4455-8e80-cb4211f3995a.html,,,,,, "Sorbitan monostearate, ethoxylated",9005-67-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43d1be44-7b37-43c8-b5e1-e1aad6413c32/documents/4a9b0ca0-b149-4aa0-af5e-164b35337181_a23c31d3-5c68-4455-8e80-cb4211f3995a.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Sorbitan monostearate, ethoxylated",9005-67-8," Acute oral toxicity:    The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.   Acute Inhalation Toxicity:   The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0089 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity:   The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43d1be44-7b37-43c8-b5e1-e1aad6413c32/documents/a4198052-69c1-40a9-a9a0-91727d5efa22_a23c31d3-5c68-4455-8e80-cb4211f3995a.html,,,,,, "Sorbitan monostearate, ethoxylated",9005-67-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43d1be44-7b37-43c8-b5e1-e1aad6413c32/documents/a4198052-69c1-40a9-a9a0-91727d5efa22_a23c31d3-5c68-4455-8e80-cb4211f3995a.html,,oral,LD50,"60,000 mg/kg bw",no adverse effect observed, "Sorbitan monostearate, ethoxylated",9005-67-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43d1be44-7b37-43c8-b5e1-e1aad6413c32/documents/a4198052-69c1-40a9-a9a0-91727d5efa22_a23c31d3-5c68-4455-8e80-cb4211f3995a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Oxybis(2,1-ethanediyloxy-2,1-ethanediyl)diacrylate",17831-71-9, An oral acute toxicity study is available on Tetraethylene Glycol Diacrylate in rats and shows a LD50 of 641 mg/kg. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7889d956-6f90-4632-bdd7-7972f0fe32ea/documents/a154db40-80e7-46e9-9e95-228412d64bc4_f52afe2e-5f9c-45df-afc3-9339d2061fda.html,,,,,, "Oxybis(2,1-ethanediyloxy-2,1-ethanediyl)diacrylate",17831-71-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7889d956-6f90-4632-bdd7-7972f0fe32ea/documents/a154db40-80e7-46e9-9e95-228412d64bc4_f52afe2e-5f9c-45df-afc3-9339d2061fda.html,,oral,LD50,641 mg/kg bw,adverse effect observed, Nonanoic acid,112-05-0,"Local irritation was seen in the forestomach in this study and in a dermal study using nonanoic acid. Valid dermal and inhalation studies are not available.Systemic toxicity is low, as evidenced by NOAEL values > 3300 mg nonanoic acid (read across from octanoic and decanoic acid) that were obtained in oral studies using triglycerides instead of the free acid. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): poor, study reliability 3 (invalid) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): Sufficient, confirms irritating properties seen in the acute toxicity tests. Single high dose was used and does not allow an exact estimation of the LOAEL or NOAEL value. This is, however, not required, because exposure in industrial settings is low. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): sufficient ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d2b03ed-7e09-47e5-ad6a-0510a866876e/documents/71db0451-551e-4472-8dde-07c5d4fe6602_d053dd39-1aca-478b-8d0e-60d6c8cacb32.html,,,,,, Nonanoic acid,112-05-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d2b03ed-7e09-47e5-ad6a-0510a866876e/documents/71db0451-551e-4472-8dde-07c5d4fe6602_d053dd39-1aca-478b-8d0e-60d6c8cacb32.html,Short-term repeated dose toxicity – systemic effects,dermal,LOAEL,500 mg/kg bw/day,,rat Nonanoic acid,112-05-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d2b03ed-7e09-47e5-ad6a-0510a866876e/documents/71db0451-551e-4472-8dde-07c5d4fe6602_d053dd39-1aca-478b-8d0e-60d6c8cacb32.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,300 mg/kg bw/day",,rat Nonanoic acid,112-05-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d2b03ed-7e09-47e5-ad6a-0510a866876e/documents/71db0451-551e-4472-8dde-07c5d4fe6602_d053dd39-1aca-478b-8d0e-60d6c8cacb32.html,Repeated dose toxicity – local effects,dermal,LOAEL,3.33 mg/cm2,adverse effect observed,rabbit Nonanoic acid,112-05-0,"The oral LD50 of pelargonic acid was determined to be > 2000 mg/kg bw in male and female rats in a valid GLP study using the Acute Toxic Class Method (OECD TG 423) (NOTOX, 2001).The inhalation LC50 of pelargonic acid was determined to be > 5.997 mg/L in a valid acute inhalation study (aerosol, nose-only exposure) (Emery, 2014).The dermal LD50 of pelargonic acid was determined to be > 2000 mg/kg bw in male and female rats in a valid GLP study according to OECD TG 402 (NOTOX, 2001). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): sufficient for assessment Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): sufficient for assessment Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): sufficient for assessment ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d2b03ed-7e09-47e5-ad6a-0510a866876e/documents/33d3c94d-886a-4223-839f-2a1247336a36_d053dd39-1aca-478b-8d0e-60d6c8cacb32.html,,,,,, Nonanoic acid,112-05-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d2b03ed-7e09-47e5-ad6a-0510a866876e/documents/33d3c94d-886a-4223-839f-2a1247336a36_d053dd39-1aca-478b-8d0e-60d6c8cacb32.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Nonanoic acid,112-05-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d2b03ed-7e09-47e5-ad6a-0510a866876e/documents/33d3c94d-886a-4223-839f-2a1247336a36_d053dd39-1aca-478b-8d0e-60d6c8cacb32.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Nonanoic acid,112-05-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d2b03ed-7e09-47e5-ad6a-0510a866876e/documents/33d3c94d-886a-4223-839f-2a1247336a36_d053dd39-1aca-478b-8d0e-60d6c8cacb32.html,,inhalation,LC50,"5,997 mg/m3",no adverse effect observed, "Pelargonium graveolens, ext.",90082-51-2, Acute oral toxicity (tested in a study similar to OECD TG 401): LD50 > 5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9822a59f-507c-4139-91cf-52b8fa6997f3/documents/62cfca86-0b0b-459a-acae-1ee20355928d_16df0764-0ec9-4083-9d9e-34451d12f9de.html,,,,,, Pentadecan-15-olide,106-02-5,"Repeated dose toxicity oral: NOAEL ≥ 1000 mg/kg bw/d (OECD 408, GLP, K, rel. 1) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93ef2e63-39f5-4e28-ba7a-ea64e20fa40a/documents/IUC5-c3bd66d3-e369-4181-8388-b9add4c72756_7ee6881e-93cb-4b93-8677-467b21a6979b.html,,,,,, Pentadecan-15-olide,106-02-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93ef2e63-39f5-4e28-ba7a-ea64e20fa40a/documents/IUC5-c3bd66d3-e369-4181-8388-b9add4c72756_7ee6881e-93cb-4b93-8677-467b21a6979b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Pentadecan-15-olide,106-02-5,Acute toxicity: oral: LD50 > 2000 mg/kg bw (WoE).Acute toxicity: dermal: LD50 > 2000 mg/kg bw ( WoE).Acute toxicity: inhalation: waiver. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93ef2e63-39f5-4e28-ba7a-ea64e20fa40a/documents/IUC5-274c7bd7-1c98-4541-a6ea-c0fe745f7593_7ee6881e-93cb-4b93-8677-467b21a6979b.html,,,,,, Pentadecan-15-olide,106-02-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93ef2e63-39f5-4e28-ba7a-ea64e20fa40a/documents/IUC5-274c7bd7-1c98-4541-a6ea-c0fe745f7593_7ee6881e-93cb-4b93-8677-467b21a6979b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Pentadecan-15-olide,106-02-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93ef2e63-39f5-4e28-ba7a-ea64e20fa40a/documents/IUC5-274c7bd7-1c98-4541-a6ea-c0fe745f7593_7ee6881e-93cb-4b93-8677-467b21a6979b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Pentadecane,629-62-9, Repeated Dose Oral 90d - NOAEL ≥ 500 mg/kg bw/day for rats (OECD 408); BMDL = 1857 mg/Kg bw/day. Repeated Dose Inhalation 90d – NOAEC ≥ 6000 mg/m3 for rats (similar to OECD TG 413) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8000af5-ff43-4202-8bec-4645711fc07a/documents/4f2db748-cf99-47c1-876e-2fafa14321e4_14146d04-eb5f-42c6-9fb2-2e84f536c22e.html,,,,,, Pentadecane,629-62-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8000af5-ff43-4202-8bec-4645711fc07a/documents/4f2db748-cf99-47c1-876e-2fafa14321e4_14146d04-eb5f-42c6-9fb2-2e84f536c22e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Pentadecane,629-62-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8000af5-ff43-4202-8bec-4645711fc07a/documents/4f2db748-cf99-47c1-876e-2fafa14321e4_14146d04-eb5f-42c6-9fb2-2e84f536c22e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"6,000 mg/m3",,rat Pentadecane,629-62-9, Acute Toxicity - Oral LD50> 5000 mg/Kg in rats (OECD TG 401) Acute Toxicity - Dermal LD50> 2000 mg/Kg in rabbits (OECD TG 402) Acute Toxicity - Inhalation LC50> 5991 mg/m3(OECD TG 403) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8000af5-ff43-4202-8bec-4645711fc07a/documents/781c2b98-0ed8-4f16-847d-a9d914ea2de7_14146d04-eb5f-42c6-9fb2-2e84f536c22e.html,,,,,, Pentadecane,629-62-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8000af5-ff43-4202-8bec-4645711fc07a/documents/781c2b98-0ed8-4f16-847d-a9d914ea2de7_14146d04-eb5f-42c6-9fb2-2e84f536c22e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Pentadecane,629-62-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8000af5-ff43-4202-8bec-4645711fc07a/documents/781c2b98-0ed8-4f16-847d-a9d914ea2de7_14146d04-eb5f-42c6-9fb2-2e84f536c22e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Pentadecane,629-62-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8000af5-ff43-4202-8bec-4645711fc07a/documents/781c2b98-0ed8-4f16-847d-a9d914ea2de7_14146d04-eb5f-42c6-9fb2-2e84f536c22e.html,,inhalation,LC50,"5,991 mg/m3",no adverse effect observed, Pentaerythritol,115-77-5,"The repeated dose oral toxicity of pentaerythritol has been investigated in the rat; the findings of these studies indicate low toxicity. A 28-day limit dose study reports a NOAEL of 1000 mg/kg bw/d; there was some indication of an effect on haematological and clinical chemistry parameters in this study, however the report author concluded that the findings were without toxicological significance. In a combined reproductive and developmental toxicity screening study, the effects of treatment in this study were limited to soft stool and/or diarrhoea at dose levels of 300 mg/kg bw/d and above. A 90-day study on pentaerythritol has been conducted in the rat where the NOAEL was considered to be 1000 mg/kg bw/day; the findings were limited to increased ploughing and salivation, attributed to be a palatability effect of the test item and vehicle and of no toxicological significance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0a453e3-ec55-4a4c-89d0-e39dd1a78cc5/documents/3f68289a-907c-43b6-944c-0c7ddb9375d2_890862d0-45d7-4416-a7e7-4eaed5508080.html,,,,,, Pentaerythritol,115-77-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0a453e3-ec55-4a4c-89d0-e39dd1a78cc5/documents/3f68289a-907c-43b6-944c-0c7ddb9375d2_890862d0-45d7-4416-a7e7-4eaed5508080.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Pentaerythritol,115-77-5,"Pentaerythritol is demonstrated to be of very low acute toxicity by all routes investigated. Acute oral LD50 values are reported to be in the range 2000-160000 mg/kg bw, with no mortality reported in rats administered a dose level of 5110 mg/kg bw. No deaths were noted in rabbits following the dermal application of a dose level of 10000 mg/kg bw. No mortality was noted in rats exposed by inhalation to 5.15 mg/L pentaerythritol dust for 4 hours and therefore the acute 4-h LC50 is > 5.15 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0a453e3-ec55-4a4c-89d0-e39dd1a78cc5/documents/795ac9ef-92f3-431c-b9fc-765c043bf107_890862d0-45d7-4416-a7e7-4eaed5508080.html,,,,,, Pentaerythritol,115-77-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0a453e3-ec55-4a4c-89d0-e39dd1a78cc5/documents/795ac9ef-92f3-431c-b9fc-765c043bf107_890862d0-45d7-4416-a7e7-4eaed5508080.html,,oral,LD50,"5,110 mg/kg bw",no adverse effect observed, Pentaerythritol,115-77-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0a453e3-ec55-4a4c-89d0-e39dd1a78cc5/documents/795ac9ef-92f3-431c-b9fc-765c043bf107_890862d0-45d7-4416-a7e7-4eaed5508080.html,,dermal,LD50,"10,000 mg/kg bw",no adverse effect observed, Pentaerythritol,115-77-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0a453e3-ec55-4a4c-89d0-e39dd1a78cc5/documents/795ac9ef-92f3-431c-b9fc-765c043bf107_890862d0-45d7-4416-a7e7-4eaed5508080.html,,inhalation,LC50,"5,150 mg/m3",no adverse effect observed, "2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate",25151-96-6,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category. All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09b756e7-4fc1-4ad7-8a21-088f520e52c1/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_43aaf256-45fb-41b8-b8a3-f16dcfb1f5b7.html,,,,,, "2,2-bis(hydroxymethyl)-1,3-propanediyl dioleate",25151-96-6,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09b756e7-4fc1-4ad7-8a21-088f520e52c1/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_43aaf256-45fb-41b8-b8a3-f16dcfb1f5b7.html,,,,,, "Resin acids and Rosin acids, hydrogenated, esters with pentaerythritol",64365-17-9," Information is available on the oral repeated dose toxicity of Rosin esters (simple, linear, and bulky). No treatment-related or biologically relevant findings were apparent in rats following oral sub-chronic dietary exposure to Resin acids and rosin acids, esters with glycerol, Resin acids and rosin acids, esters with ethylene glycol, Resin acids and rosin acids, esters with triethylene glycol, Resin acids and rosin acids, hydrogenated, esters with glycerol and Resin acids and rosin acids, hydrogenated, esters with pentaerythritol. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/692e5410-066e-4513-b041-fa8c5dfecae6/documents/e379bfe8-0297-4f60-88f4-e0ce763f2bab_7a8d014f-54cf-4b1e-9519-bd46fc400b3f.html,,,,,, "Resin acids and Rosin acids, hydrogenated, esters with pentaerythritol",64365-17-9,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/692e5410-066e-4513-b041-fa8c5dfecae6/documents/a4c4e4b1-07c1-416e-a09d-3b9c52eec7cf_7a8d014f-54cf-4b1e-9519-bd46fc400b3f.html,,,,,, "Resin acids and Rosin acids, hydrogenated, esters with pentaerythritol",64365-17-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/692e5410-066e-4513-b041-fa8c5dfecae6/documents/a4c4e4b1-07c1-416e-a09d-3b9c52eec7cf_7a8d014f-54cf-4b1e-9519-bd46fc400b3f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, hydrogenated, esters with pentaerythritol",64365-17-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/692e5410-066e-4513-b041-fa8c5dfecae6/documents/a4c4e4b1-07c1-416e-a09d-3b9c52eec7cf_7a8d014f-54cf-4b1e-9519-bd46fc400b3f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, esters with pentaerythritol",8050-26-8," Information is available on the oral repeated dose toxicity of Rosin esters (simple, linear, and bulky). No treatment-related or biologically relevant findings were apparent in rats following oral sub-chronic dietary exposure to Resin acids and rosin acids, esters with glycerol, Resin acids and rosin acids, esters with ethylene glycol, Resin acids and rosin acids, esters with triethylene glycol, Resin acids and rosin acids, hydrogenated, esters with glycerol and Resin acids and rosin acids, hydrogenated, esters with pentaerythritol. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b09c803-e388-4665-b239-7d8833916fbd/documents/c94bffc1-bd0f-4f45-be08-2592615e60a7_c495ffb7-5196-458e-8d67-273e20f3d15a.html,,,,,, "Resin acids and Rosin acids, esters with pentaerythritol",8050-26-8,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b09c803-e388-4665-b239-7d8833916fbd/documents/465652e9-bb43-4c9e-b006-48c087faaeac_c495ffb7-5196-458e-8d67-273e20f3d15a.html,,,,,, "Resin acids and Rosin acids, esters with pentaerythritol",8050-26-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b09c803-e388-4665-b239-7d8833916fbd/documents/465652e9-bb43-4c9e-b006-48c087faaeac_c495ffb7-5196-458e-8d67-273e20f3d15a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, esters with pentaerythritol",8050-26-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b09c803-e388-4665-b239-7d8833916fbd/documents/465652e9-bb43-4c9e-b006-48c087faaeac_c495ffb7-5196-458e-8d67-273e20f3d15a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C5-10, esters with pentaerythritol",68424-31-7, All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L. The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31c274cc-907f-484f-89fb-9a4deae2e0bc/documents/bf204c9c-61a3-4717-ba0e-db21da0f7e49_0fd9a7f3-ec18-42bc-8654-1b3c2fa6ff8f.html,,,,,, "Fatty acids, C5-10, esters with pentaerythritol",68424-31-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31c274cc-907f-484f-89fb-9a4deae2e0bc/documents/bf204c9c-61a3-4717-ba0e-db21da0f7e49_0fd9a7f3-ec18-42bc-8654-1b3c2fa6ff8f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C5-10, esters with pentaerythritol",68424-31-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31c274cc-907f-484f-89fb-9a4deae2e0bc/documents/bf204c9c-61a3-4717-ba0e-db21da0f7e49_0fd9a7f3-ec18-42bc-8654-1b3c2fa6ff8f.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rabbit "Fatty acids, C5-10, esters with pentaerythritol",68424-31-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31c274cc-907f-484f-89fb-9a4deae2e0bc/documents/bf204c9c-61a3-4717-ba0e-db21da0f7e49_0fd9a7f3-ec18-42bc-8654-1b3c2fa6ff8f.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,0.5 mg/m3,,rat "Fatty acids, C5-10, esters with pentaerythritol",68424-31-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31c274cc-907f-484f-89fb-9a4deae2e0bc/documents/bf204c9c-61a3-4717-ba0e-db21da0f7e49_0fd9a7f3-ec18-42bc-8654-1b3c2fa6ff8f.html,Repeated dose toxicity – local effects,dermal,NOAEL,"2,000 mg/cm2",no adverse effect observed,rabbit "Fatty acids, C5-10, esters with pentaerythritol",68424-31-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31c274cc-907f-484f-89fb-9a4deae2e0bc/documents/bf204c9c-61a3-4717-ba0e-db21da0f7e49_0fd9a7f3-ec18-42bc-8654-1b3c2fa6ff8f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.5 mg/m3,no adverse effect observed,rat "Fatty acids, C5-10, esters with pentaerythritol",68424-31-7, All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31c274cc-907f-484f-89fb-9a4deae2e0bc/documents/4259e672-86d1-4108-878c-bcfe15b17aed_0fd9a7f3-ec18-42bc-8654-1b3c2fa6ff8f.html,,,,,, "Fatty acids, C5-9, tetraesters with pentaerythritol",67762-53-2,All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aea20891-75c3-4f3b-8917-c8fbcb303045/documents/IUC5-f11a4a0f-0777-4bd0-af71-a0dab4a79c01_6f51669f-2459-435f-b0c2-92d9bb1fad49.html,,,,,, "Fatty acids, C5-9, tetraesters with pentaerythritol",67762-53-2,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aea20891-75c3-4f3b-8917-c8fbcb303045/documents/IUC5-f8900334-5c9a-45d2-9c9a-4aa5ddf9d788_6f51669f-2459-435f-b0c2-92d9bb1fad49.html,,,,,, "Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)",6683-19-8, Adequate repeated-dose toxicity studies predating GLP but performed similar to OECD guidelines 409 and 453 are available. A 3-month feeding study in beagle dogs revealed no relevant toxicological effects and a NOEL of 10000 ppm was derived. In a chronic feeding study in rats a NOEL of 3000 ppm was derived based on an intermittent reduction in body weight gain at the high dose level. Since the toxicological relevance of this finding is doubtful the NOAEL can be set at 10000 ppm. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9dbcf6ac-2e27-4cf3-9df3-4ce86f65dd96/documents/IUC5-6711051f-5a3c-4752-ad52-8556c32e22c9_aa252d61-c9fd-439c-870d-0c74452c6956.html,,,,,, "Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)",6683-19-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9dbcf6ac-2e27-4cf3-9df3-4ce86f65dd96/documents/IUC5-6711051f-5a3c-4752-ad52-8556c32e22c9_aa252d61-c9fd-439c-870d-0c74452c6956.html,Chronic toxicity – systemic effects,oral,NOAEL,446 mg/kg bw/day,,rat "Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)",6683-19-8," No mortality was observed after oral, dermal, inhalatory or intraperitoneal application of a single dose of 5000 mg/kg body weight, 3160 mg/kg body weight, 1951 mg/m³ and 1000 mg/kg body weight, respectively. All studies were performed prior to GLP requirements but are adequately reported for evaluation. Minor deviations include the recording of body weight or autopsy findings for some studies. Transient clinical signs resolved within the post-treatment observation period. There were no findings indicative of target organ toxicity. Acute oral, intraperitoneal and inhalation toxicity was studied on rats. Acute dermal toxicity was investigated on rabbits. Acute oral toxicity was also studied in mice. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9dbcf6ac-2e27-4cf3-9df3-4ce86f65dd96/documents/IUC5-092015ca-e84e-42d0-aac0-66c1962d96a5_aa252d61-c9fd-439c-870d-0c74452c6956.html,,,,,, "Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)",6683-19-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9dbcf6ac-2e27-4cf3-9df3-4ce86f65dd96/documents/IUC5-092015ca-e84e-42d0-aac0-66c1962d96a5_aa252d61-c9fd-439c-870d-0c74452c6956.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)",6683-19-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9dbcf6ac-2e27-4cf3-9df3-4ce86f65dd96/documents/IUC5-092015ca-e84e-42d0-aac0-66c1962d96a5_aa252d61-c9fd-439c-870d-0c74452c6956.html,,dermal,LD50,"3,160 mg/kg bw",no adverse effect observed, "Pentaerythritol tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate)",6683-19-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9dbcf6ac-2e27-4cf3-9df3-4ce86f65dd96/documents/IUC5-092015ca-e84e-42d0-aac0-66c1962d96a5_aa252d61-c9fd-439c-870d-0c74452c6956.html,,inhalation,LC50,"1,951 mg/m3",no adverse effect observed, "2-Propenoic acid, reaction products with pentaerythritol",1245638-61-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): More reliable of two studies. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5612548-4a66-4b7d-81d3-3f706691603d/documents/IUC5-deb79378-1c94-4316-bcb6-4b7cb96c9605_7035885d-70f2-4b4e-a64d-61b2dd1627cb.html,,,,,, "2-Propenoic acid, reaction products with pentaerythritol",1245638-61-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5612548-4a66-4b7d-81d3-3f706691603d/documents/IUC5-deb79378-1c94-4316-bcb6-4b7cb96c9605_7035885d-70f2-4b4e-a64d-61b2dd1627cb.html,,oral,LD50,540 mg/kg bw,adverse effect observed, "2-Propenoic acid, reaction products with pentaerythritol",1245638-61-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5612548-4a66-4b7d-81d3-3f706691603d/documents/IUC5-deb79378-1c94-4316-bcb6-4b7cb96c9605_7035885d-70f2-4b4e-a64d-61b2dd1627cb.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Decanoic acid, mixed esters with octanoic acid and pentaerythritol",68441-68-9," Oral (OECD 408, rat): NOAEL ≥ 1000 mg/kg bw/day Inhalation (similar to OECD 413, rat): NOAEC = 0.5 mg/L Dermal (similar to OECD 411, rat): NOAEL ≥ 2000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3716c63a-01bc-45a7-a274-5e57c02da598/documents/44a971c2-7cb9-4721-a26f-cabe47886065_b23ae381-fc0c-40ae-8233-cbda154871cf.html,,,,,, "Decanoic acid, mixed esters with octanoic acid and pentaerythritol",68441-68-9, Oral: LD50 > 2000 mg/kg bw Inhalation: LC50 > 4.06 mg/L Dermal: LD50 > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3716c63a-01bc-45a7-a274-5e57c02da598/documents/1dc37891-570f-404f-9522-9cb604491bf0_b23ae381-fc0c-40ae-8233-cbda154871cf.html,,,,,, "2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)",7299-99-2,90-day sub-chronic study. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fe210f9-4a0d-48e3-9e66-1bdcd7fb5471/documents/IUC5-93ced20d-e7e1-40dd-a9c6-2f030c530413_8f29007b-b077-4e8a-b338-9240e1bf4f73.html,,,,,, "2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)",7299-99-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fe210f9-4a0d-48e3-9e66-1bdcd7fb5471/documents/IUC5-93ced20d-e7e1-40dd-a9c6-2f030c530413_8f29007b-b077-4e8a-b338-9240e1bf4f73.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)",7299-99-2,Acute oral toxicity > 5000 mg/kg (substance)Acute dermal toxicity > 2000 mg/kg (read across to structural analogue) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fe210f9-4a0d-48e3-9e66-1bdcd7fb5471/documents/IUC5-82918ad2-d953-4eeb-9e48-de03f8416f69_8f29007b-b077-4e8a-b338-9240e1bf4f73.html,,,,,, "2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)",7299-99-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fe210f9-4a0d-48e3-9e66-1bdcd7fb5471/documents/IUC5-82918ad2-d953-4eeb-9e48-de03f8416f69_8f29007b-b077-4e8a-b338-9240e1bf4f73.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,2-bis[[(2-ethyl-1-oxohexyl)oxy]methyl]propane-1,3-diyl bis(2-ethylhexanoate)",7299-99-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fe210f9-4a0d-48e3-9e66-1bdcd7fb5471/documents/IUC5-82918ad2-d953-4eeb-9e48-de03f8416f69_8f29007b-b077-4e8a-b338-9240e1bf4f73.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoate",93803-89-5,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.Repeated dose toxicity: Oral NOAEL (rat, m/f): 1000 mg/kg bw/day (OECD 408, GLP analogue approach) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4907ef13-82f5-488c-bde8-8bceb8f152e9/documents/IUC5-ef753fe5-8740-4acc-ba97-4a572c9efb12_04d5c003-f853-4fbe-8d93-d95ede612ffb.html,,,,,, "2,2-bis[[(1-oxoisononyl)oxy]methyl]-1,3-propanediyl diisononanoate",93803-89-5,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401, GLP, analogue approach)Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, GLP, analogue approach)Acute toxicity: Inhalation LC50 (rat, m/f): > 5.0 mg/L air (OECD 403, analogue approach) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4907ef13-82f5-488c-bde8-8bceb8f152e9/documents/IUC5-69f959ab-8c8c-4b4c-b4c9-e3f0e3e460a7_04d5c003-f853-4fbe-8d93-d95ede612ffb.html,,,,,, "2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate)",62125-22-8,All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a75bfc6a-816d-4e62-a4c0-52e7cbc46ec1/documents/IUC5-4db560c8-493c-4521-8a14-92803846f04a_28ead589-3194-4f19-90be-97be5673b096.html,,,,,, "2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate)",62125-22-8,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a75bfc6a-816d-4e62-a4c0-52e7cbc46ec1/documents/IUC5-beb4b226-223d-4e7d-8c54-2e78377f6ab1_28ead589-3194-4f19-90be-97be5673b096.html,,,,,, "3-[(3-sulfanylbutanoyl)oxy]-2,2-bis{[(3-sulfanylbutanoyl)oxy]methyl}propyl 3-sulfanylbutanoate",31775-89-0," Oral, 28 days, rat: NOAEL (systemic) = 150 mg/kg bw/day (similar to OECD 407) Oral, 90 days, rat: NOAEL (systemic) = 150 mg/kg bw/day (similar to OECD 408) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64f25607-ddff-4db1-b509-7d7f3de76c9c/documents/IUC5-6a96ffcb-f4db-4afd-b048-c9a91afd2e54_65a1ea25-95c7-4a95-96bc-f734d037373d.html,,,,,, "3-[(3-sulfanylbutanoyl)oxy]-2,2-bis{[(3-sulfanylbutanoyl)oxy]methyl}propyl 3-sulfanylbutanoate",31775-89-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64f25607-ddff-4db1-b509-7d7f3de76c9c/documents/IUC5-6a96ffcb-f4db-4afd-b048-c9a91afd2e54_65a1ea25-95c7-4a95-96bc-f734d037373d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "3-[(3-sulfanylbutanoyl)oxy]-2,2-bis{[(3-sulfanylbutanoyl)oxy]methyl}propyl 3-sulfanylbutanoate",31775-89-0,"Oral (OECD 420), rat: LD50 > 2000 mg/kg bw (limit test)Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64f25607-ddff-4db1-b509-7d7f3de76c9c/documents/IUC5-8af95bbd-8685-4d85-870c-e03338ad73dc_65a1ea25-95c7-4a95-96bc-f734d037373d.html,,,,,, "3-[(3-sulfanylbutanoyl)oxy]-2,2-bis{[(3-sulfanylbutanoyl)oxy]methyl}propyl 3-sulfanylbutanoate",31775-89-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64f25607-ddff-4db1-b509-7d7f3de76c9c/documents/IUC5-8af95bbd-8685-4d85-870c-e03338ad73dc_65a1ea25-95c7-4a95-96bc-f734d037373d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3-[(3-sulfanylbutanoyl)oxy]-2,2-bis{[(3-sulfanylbutanoyl)oxy]methyl}propyl 3-sulfanylbutanoate",31775-89-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64f25607-ddff-4db1-b509-7d7f3de76c9c/documents/IUC5-8af95bbd-8685-4d85-870c-e03338ad73dc_65a1ea25-95c7-4a95-96bc-f734d037373d.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Pentaerythritol tetrakis(3-mercaptopropionate),7575-23-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2754df3f-783f-42d0-b870-43aa708dd3c8/documents/IUC5-a9f6461a-35f2-4fe1-9fe6-69bdbc5ebaf0_0037c10e-5d31-435f-aba8-e2042eebe720.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Pentaerythritol tetrakis(3-mercaptopropionate),7575-23-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2754df3f-783f-42d0-b870-43aa708dd3c8/documents/IUC5-57b55f68-4878-44d0-ba43-9a8ec2f94b33_0037c10e-5d31-435f-aba8-e2042eebe720.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, Pentaerythritol tetrakis(3-mercaptopropionate),7575-23-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2754df3f-783f-42d0-b870-43aa708dd3c8/documents/IUC5-57b55f68-4878-44d0-ba43-9a8ec2f94b33_0037c10e-5d31-435f-aba8-e2042eebe720.html,,inhalation,LC50,"3,363 mg/m3",no adverse effect observed, Pentaerythritol tetraoleate,19321-40-5,All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dba7d09-e357-4678-8667-406f805cd3d7/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_9713c08c-ccc5-4423-9bcd-f0edf7ec57dc.html,,,,,, Pentaerythritol tetraoleate,19321-40-5,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dba7d09-e357-4678-8667-406f805cd3d7/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_9713c08c-ccc5-4423-9bcd-f0edf7ec57dc.html,,,,,, Pentaerythritol tetrastearate,115-83-3," Oral (Read-across, OECD 407): sub-acute NOAEL rat ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4aaffa32-2068-4937-af53-c3b10030d619/documents/5bae2765-9860-4b89-b389-d21cce72912a_d55e1d20-4704-4709-98f1-46d030ddc4a7.html,,,,,, Pentaerythritol tetrastearate,115-83-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4aaffa32-2068-4937-af53-c3b10030d619/documents/5bae2765-9860-4b89-b389-d21cce72912a_d55e1d20-4704-4709-98f1-46d030ddc4a7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Pentaerythritol tetrastearate,115-83-3," Oral (Read-across, according to OECD 401): LD50 rat > 2000 mg/kg bw Inhalation (Read-across, according to OECD 403): LC50 rat: >5.1 mg/L air Dermal (Read-across, according to OECD 402): LD50 rat > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aaffa32-2068-4937-af53-c3b10030d619/documents/88e09ff5-07fc-48ec-82fe-e92bd1614fff_d55e1d20-4704-4709-98f1-46d030ddc4a7.html,,,,,, Pentane,109-66-0," Repeated Dose Inhalation 90d – NOAEC = 20,000 mg/m3 for rats (OECD TG 413) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9386c569-61b1-489f-be53-52d174a37d37/documents/4ed4ae68-6094-416c-98e7-b3d36d49bd69_355c9498-fb77-48e3-93eb-b79b623cf1b2.html,,,,,, Pentane,109-66-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9386c569-61b1-489f-be53-52d174a37d37/documents/4ed4ae68-6094-416c-98e7-b3d36d49bd69_355c9498-fb77-48e3-93eb-b79b623cf1b2.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"20,000 mg/m3",,rat Pentane,109-66-0, Acute toxicity oral LD50 >2000 mg/kg in rats (OECD TG 401) Acute toxicity inhalation LC50 >25.3 mg/L (25300 mg/m3) in rats (OECD TG 403) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9386c569-61b1-489f-be53-52d174a37d37/documents/2ef254fb-68ef-43b9-8179-b6ec00704011_355c9498-fb77-48e3-93eb-b79b623cf1b2.html,,,,,, Pentane,109-66-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9386c569-61b1-489f-be53-52d174a37d37/documents/2ef254fb-68ef-43b9-8179-b6ec00704011_355c9498-fb77-48e3-93eb-b79b623cf1b2.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Pentane,109-66-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9386c569-61b1-489f-be53-52d174a37d37/documents/2ef254fb-68ef-43b9-8179-b6ec00704011_355c9498-fb77-48e3-93eb-b79b623cf1b2.html,,inhalation,LC50,"> 25,300 mg/m3",no adverse effect observed, Pentan-2-one,107-87-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6167ab3-bae0-4d6d-9b06-36da57b8f7dc/documents/IUC5-863f91e1-9390-47d7-bc02-90cc259fbd8c_54b88ff6-0a49-46eb-b216-9998f6eda111.html,Sub-chronic toxicity – systemic effects,inhalation,,"5,284 mg/m3",,rat Pentan-2-one,107-87-9,Acute oral studies with rats and mice are available. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6167ab3-bae0-4d6d-9b06-36da57b8f7dc/documents/IUC5-4311cf8b-73b2-4241-b52e-dd10fbec511e_54b88ff6-0a49-46eb-b216-9998f6eda111.html,,,,,, Pentan-2-one,107-87-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6167ab3-bae0-4d6d-9b06-36da57b8f7dc/documents/IUC5-4311cf8b-73b2-4241-b52e-dd10fbec511e_54b88ff6-0a49-46eb-b216-9998f6eda111.html,,oral,LD50,"1,600 mg/kg bw",adverse effect observed, Pentan-2-one,107-87-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6167ab3-bae0-4d6d-9b06-36da57b8f7dc/documents/IUC5-4311cf8b-73b2-4241-b52e-dd10fbec511e_54b88ff6-0a49-46eb-b216-9998f6eda111.html,,inhalation,LC50,"25,500 mg/m3",adverse effect observed, Pentapotassium triphosphate,13845-36-8,"REPEATED DOSE TOXICITY: ORAL.- Short term toxicity: Four studies are available for this endpoint. The two key studies (both Hodge 1956) tested the analogous substance pentasodium triphosphate on rats and dogs. The studies are comparable to modern day guidelines with acceptable deficiencies and were conducted before the implementation of GLP.Two supporting studies are included, however they are not considered acceptable for assessment due to methodological inadequacies.- Sub chronic toxicity:One study is available, however, due to methodological inadequacies it is not considered to be acceptable for assessment. According to Annex IX, section 8.6.2, column 2 of Regulation No. 1907/2006, a subchronic (90 day) study does not need to be conducted as a reliable chronic toxicity study is available.- Chronic toxicity:A 2-year study on rats is available for the analogous substance STPP (Hodge 1959). The study is conducted before the implementation of GLP and is comparable to modern day guidelines with acceptable deficiencies (these are described in the toxicologists expert statement which is included in this endpoint record). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36ddad77-f210-420a-8b98-04736509ff61/documents/IUC5-425b5d89-0954-49ec-bcd3-9caaf07502de_0cebf91b-cac4-4413-a938-77988c329615.html,,,,,, Pentapotassium triphosphate,13845-36-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36ddad77-f210-420a-8b98-04736509ff61/documents/IUC5-425b5d89-0954-49ec-bcd3-9caaf07502de_0cebf91b-cac4-4413-a938-77988c329615.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Pentapotassium triphosphate,13845-36-8," Acute oral toxicity: Two studies are available to assess the oral toxicity of pentapotassium triphosphate [KTPP]. Taken together the studies indicate that KTPP has a low potential for systemic toxicity following acute administration via the oral route. The acute oral median dose (LD50) was estimated to be > 2000 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP). An additional supporting study (Kamienski 1971) confirms the overall classification; however, this study is not sufficient as a stand-alone data source for this endpoint. Acute inhalation toxicity: As part of a read-across argument a key study for pentasodium triphosphate [STPP] has been included in section 7.2.2 of this dossier. The read across key study (Jackson GC, 1988) has been conducted according to guideline EPA OPP 81-3 (Acute inhalation toxicity), and according to the principles of GLP. The acute inhalation median concentration (LC50) of the read across substance was estimated to be > 0.39 mg/L (the maximum attainable concentration) in male and female rats. Acute dermal toxicity: Testing was waived on the basis that further in vivo testing is considered to be scientifically unjustified. In addition, a read-across study from similar substance pentasodium triphosphate supports the arguments made in the waiver. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36ddad77-f210-420a-8b98-04736509ff61/documents/7799d255-3c5f-4911-8f4a-054f1806b1b0_0cebf91b-cac4-4413-a938-77988c329615.html,,,,,, Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate,140-01-2,"One 28-day oral gavage study in rats using pentapotassium DTPA and one 28-day oral, drinking water study using pentasodium DTPA. Additional information comes from published literature on othe salts of DTPA such as zinc and calciumSubchronic 90-day OECD 413 guideline compliant inhalation study performed on suitable read-across substance, Na2H2EDTA. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4b9b041-b056-422c-a05f-cca1409a1cd3/documents/48e75a5c-ac57-4e5b-8878-aea8d3479aa3_30df1cc2-e907-4296-b620-f41091a68d21.html,,,,,, Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate,140-01-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4b9b041-b056-422c-a05f-cca1409a1cd3/documents/48e75a5c-ac57-4e5b-8878-aea8d3479aa3_30df1cc2-e907-4296-b620-f41091a68d21.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,, Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate,140-01-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4b9b041-b056-422c-a05f-cca1409a1cd3/documents/48e75a5c-ac57-4e5b-8878-aea8d3479aa3_30df1cc2-e907-4296-b620-f41091a68d21.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,15 mg/m3,,rat Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate,140-01-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4b9b041-b056-422c-a05f-cca1409a1cd3/documents/48e75a5c-ac57-4e5b-8878-aea8d3479aa3_30df1cc2-e907-4296-b620-f41091a68d21.html,Repeated dose toxicity – local effects,inhalation,NOAEC,3 mg/m3,adverse effect observed,rat Pentasodium (carboxylatomethyl)iminobis(ethylenenitrilo)tetraacetate,140-01-2,Oral: 1 acute oral study using DTPA acid; 4 acute oral studies using pentasodium DTPA; 2 acute oral studies using pentapotassium DTPA.Dermal: 1 acute dermal study using pentapotassium DTPAInhalation: 1 acute inhalation study using pentasodium DTPA; 1 sub-acute inhalation study using Disodium EDTA (read across) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4b9b041-b056-422c-a05f-cca1409a1cd3/documents/898d1a0b-6150-46ed-aa70-6e6f31e84a54_30df1cc2-e907-4296-b620-f41091a68d21.html,,,,,, Pentasodium triphosphate,7758-29-4,"Sodium Tripolyphosphate (Curafos) was assessed in a series of oral repeated dose toxicity studies in rats and dogs. A publication summarizes the main findings from several unpublished company studies although limited details were reported on the test results (Hodge, 1964). However, the full laboratory reports of these tests were available and are considered a Key Study because of the complete information contained in them. A toxicologist expert assessment of these laboratory reports was obtained and used as the basis for this section. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35520e6b-cf9e-43f0-97e7-9990a372f1a0/documents/IUC5-28593b7f-af09-4e4a-a7a7-a67b7845d6f9_cba6d055-29e2-4279-a685-b79a2eaf76d2.html,,,,,, Pentasodium triphosphate,7758-29-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35520e6b-cf9e-43f0-97e7-9990a372f1a0/documents/IUC5-28593b7f-af09-4e4a-a7a7-a67b7845d6f9_cba6d055-29e2-4279-a685-b79a2eaf76d2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,225 mg/kg bw/day,, Pentasodium triphosphate,7758-29-4,Experimental data showed a low acute toxicity potential for STPP by the oral or dermal routes with LD50 values greater than 2000 mg/kg by either routes. The maximum attainable concentration of STPP that could be technically generated showed no significant clinical signs except reactions consistent with exposure to an irritant dust. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35520e6b-cf9e-43f0-97e7-9990a372f1a0/documents/IUC5-7f1f1edc-18f1-46d1-8629-836dbf89669a_cba6d055-29e2-4279-a685-b79a2eaf76d2.html,,,,,, Pentasodium triphosphate,7758-29-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35520e6b-cf9e-43f0-97e7-9990a372f1a0/documents/IUC5-7f1f1edc-18f1-46d1-8629-836dbf89669a_cba6d055-29e2-4279-a685-b79a2eaf76d2.html,,oral,LD50,"2,000 mg/kg bw",, Pentasodium triphosphate,7758-29-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35520e6b-cf9e-43f0-97e7-9990a372f1a0/documents/IUC5-7f1f1edc-18f1-46d1-8629-836dbf89669a_cba6d055-29e2-4279-a685-b79a2eaf76d2.html,,dermal,LD50,"4,640 mg/kg bw",, Pentasodium triphosphate,7758-29-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35520e6b-cf9e-43f0-97e7-9990a372f1a0/documents/IUC5-7f1f1edc-18f1-46d1-8629-836dbf89669a_cba6d055-29e2-4279-a685-b79a2eaf76d2.html,,inhalation,LC50,390 mg/m3,, N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid),67-43-6,"One 28-day oral gavage study in rats using pentapotassium DTPA and one 28-day oral, drinking water study using pentasodium DTPA. Additional information comes from published literature on othe salts of DTPA such as zinc and calcium   Subchronic 90-day OECD 413 guideline compliant inhalation study performed on suitable read-across substance, Na2H2EDTA.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): See read across argumentation in section 7 (DNEL setting) and read across document in section 13. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): See read across argumentation in section 7 (DNEL setting) and read across document in section 13. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): See read across argumentation in section 7 (DNEL setting) and in section 13. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21aa938a-40cd-4585-9a67-5f22df476abb/documents/IUC5-81d7b482-90d7-4006-81d2-a57c3708731f_e7aa4527-8c4f-47fe-9a11-7b71e4aba00c.html,,,,,, N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid),67-43-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21aa938a-40cd-4585-9a67-5f22df476abb/documents/IUC5-81d7b482-90d7-4006-81d2-a57c3708731f_e7aa4527-8c4f-47fe-9a11-7b71e4aba00c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid),67-43-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21aa938a-40cd-4585-9a67-5f22df476abb/documents/IUC5-81d7b482-90d7-4006-81d2-a57c3708731f_e7aa4527-8c4f-47fe-9a11-7b71e4aba00c.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,15 mg/m3,,rat N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid),67-43-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21aa938a-40cd-4585-9a67-5f22df476abb/documents/IUC5-81d7b482-90d7-4006-81d2-a57c3708731f_e7aa4527-8c4f-47fe-9a11-7b71e4aba00c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,3 mg/m3,adverse effect observed,rat N-carboxymethyliminobis(ethylenenitrilo)tetra(acetic acid),67-43-6,Oral: 1 acute oral study using DTPA acid; 4 acute oral studies using pentasodium DTPA; 2 acute oral studies using pentapotassium DTPA.Dermal: 1 acute dermal study using pentapotassium DTPAInhalation: 1 acute inhalation study using pentasodium DTPA and 1 using a structurally related compound disodium EDTA (EDTA-Na2H2) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21aa938a-40cd-4585-9a67-5f22df476abb/documents/IUC5-1acbb1d9-88cd-4e58-adf7-56b7ad60a4b9_e7aa4527-8c4f-47fe-9a11-7b71e4aba00c.html,,,,,, "Pentane-1,2-diol",5343-92-0,"Repeated dose toxicity:- oral: NOAEL = 1000 mg/kg bw (OECD 408; OECD 422, Analogy CAS 584-03-2)- dermal (local): NOAEL = 700 mg/kg bw (OECD 411, Analogy CAS 6920-22-5)- dermal (systemic): NOAEL = 1000 mg/kg bw (OECD 411, Analogy CAS 6920-22-5) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/609eac49-e9bf-46b1-b7c0-ce8637d86070/documents/IUC5-e11b1dde-8970-4914-ad86-31f36eed0922_36ddd94e-a00f-43f7-bc3d-97cfc19b3c11.html,,,,,, "Pentane-1,2-diol",5343-92-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/609eac49-e9bf-46b1-b7c0-ce8637d86070/documents/IUC5-e11b1dde-8970-4914-ad86-31f36eed0922_36ddd94e-a00f-43f7-bc3d-97cfc19b3c11.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, "Pentane-1,2-diol",5343-92-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/609eac49-e9bf-46b1-b7c0-ce8637d86070/documents/IUC5-e11b1dde-8970-4914-ad86-31f36eed0922_36ddd94e-a00f-43f7-bc3d-97cfc19b3c11.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Pentane-1,2-diol",5343-92-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/609eac49-e9bf-46b1-b7c0-ce8637d86070/documents/IUC5-e11b1dde-8970-4914-ad86-31f36eed0922_36ddd94e-a00f-43f7-bc3d-97cfc19b3c11.html,Repeated dose toxicity – local effects,dermal,NOAEL,10.9 mg/cm2,adverse effect observed, "Pentane-1,2-diol",5343-92-0,Acute toxicity:- oral: LD50 >5000 mg/kg bw (OECD 401)- inhalative: LC50 >7015 mg/m3 (equivalent to OECD 403)- dermal: LD50 > 2000 mg/kg bw (OECD 402) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/609eac49-e9bf-46b1-b7c0-ce8637d86070/documents/IUC5-f90531e7-81db-4828-8f55-6f5c9059ed25_36ddd94e-a00f-43f7-bc3d-97cfc19b3c11.html,,,,,, "Pentane-1,2-diol",5343-92-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/609eac49-e9bf-46b1-b7c0-ce8637d86070/documents/IUC5-f90531e7-81db-4828-8f55-6f5c9059ed25_36ddd94e-a00f-43f7-bc3d-97cfc19b3c11.html,,oral,LD50,"5,000 mg/kg bw",, "Pentane-1,2-diol",5343-92-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/609eac49-e9bf-46b1-b7c0-ce8637d86070/documents/IUC5-f90531e7-81db-4828-8f55-6f5c9059ed25_36ddd94e-a00f-43f7-bc3d-97cfc19b3c11.html,,dermal,LD50,"2,000 mg/kg bw",, "Pentane-1,2-diol",5343-92-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/609eac49-e9bf-46b1-b7c0-ce8637d86070/documents/IUC5-f90531e7-81db-4828-8f55-6f5c9059ed25_36ddd94e-a00f-43f7-bc3d-97cfc19b3c11.html,,inhalation,LC50,"7,015 mg/m3",, Tetradecafluorohexane,355-42-0," An Acute toxicity study in rat by oral route was performed for Reach registration purpose (OECD TG 423). Two studies available in published scientific litterature were available reporting no adverse effect in rats and pigs after exposure to tetradecafluorohexane by inhalation. An acute toxicity study in rat by intravenous route was available in the New Drug Application dossier of AF150 evaluated by US-FDA. As AF150 is tetradecafluorohexane encapsulated in lipid microspheres to allow intravenous administration and to enhance the biodisponibility of tetradecafluorohexane, this study was considered relevant to assess the systemic toxicity of tetradecafluorohexane. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f1b0deb-16f5-4095-9e35-22a21afba11a/documents/c65be101-d104-4235-95af-7c82c4733b92_20c82495-9192-48e2-ab03-da62f6024608.html,,,,,, "Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane",51851-37-7," In the Combined Repeated Dose Oral Toxicity Study with the Reproduction / Developmental Toxicity Screening Test, conducted according to OECD Test Guideline 422 and in compliance with GLP, the reported NOAEL value for general systemic toxicity for [2-(perfluorohexyl)ethyl]triethoxysilane was 50 mg/kg bw/day (Eurofins, 2017, reliability 1). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/795d76a5-237f-4c86-bf98-44d6c32d4224/documents/7ce77e65-c83d-4d68-bc0b-d0d9397a910b_16292274-3ea8-4b12-ae48-be15b77d1561.html,,,,,, "Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane",51851-37-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/795d76a5-237f-4c86-bf98-44d6c32d4224/documents/7ce77e65-c83d-4d68-bc0b-d0d9397a910b_16292274-3ea8-4b12-ae48-be15b77d1561.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane",51851-37-7," [2-(Perfluorohexyl)ethyl]triethoxysilane has been tested in an acute oral toxicity study conducted according to OECD Test Guideline 423 and in compliance with GLP. The LD50 was determined to be >2000 mg/kg bw (Hüls, 1997a, reliability 1). The key study for acute dermal toxicity reported an LD₅₀ value of > 2000 mg/kg bw [2-(perfluorohexyl)ethyl]triethoxysilane, determined in a reliable study conducted according to GLP and current OECD TG 403 (Hüls, 1997b, reliability 1). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/795d76a5-237f-4c86-bf98-44d6c32d4224/documents/7dcc1ea7-fc12-47a6-beb8-d1f467cee696_16292274-3ea8-4b12-ae48-be15b77d1561.html,,,,,, "Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane",51851-37-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/795d76a5-237f-4c86-bf98-44d6c32d4224/documents/7dcc1ea7-fc12-47a6-beb8-d1f467cee696_16292274-3ea8-4b12-ae48-be15b77d1561.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Triethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane",51851-37-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/795d76a5-237f-4c86-bf98-44d6c32d4224/documents/7dcc1ea7-fc12-47a6-beb8-d1f467cee696_16292274-3ea8-4b12-ae48-be15b77d1561.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Petrolatum,8009-03-8,"Data available on similar materials are sufficient to adequately characterize the repeated oral toxicity and the repeated dermal toxicity of insufficiently refined petrolatum and sufficiently refined petrolatum. The data are consistent in that they demonstrate minimal effects in rats and rabbits with the exception of minimal to moderate skin irritation following repeated dermal exposures and histopathological changes with questionable relevance to humans following repeated oral exposures. Potential exposures by inhalation are expected to be low due to the low vapour pressures of petrolatum. Accordingly, it does not seem likely that there is any potential for petrolatum to produce repeated dose toxicity by an inhalation route. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3be3d5b1-8c28-4833-8f12-184100735862/documents/41098277-a189-417c-b267-9953f928d6b5_66ce0fd9-a37f-4290-84d0-cc4af9071ffa.html,,,,,, Petrolatum,8009-03-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3be3d5b1-8c28-4833-8f12-184100735862/documents/41098277-a189-417c-b267-9953f928d6b5_66ce0fd9-a37f-4290-84d0-cc4af9071ffa.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat Petrolatum,8009-03-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3be3d5b1-8c28-4833-8f12-184100735862/documents/41098277-a189-417c-b267-9953f928d6b5_66ce0fd9-a37f-4290-84d0-cc4af9071ffa.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse Petrolatum,8009-03-8,The acute toxicity of petrolatum (carcinogenic or unknown feed-stock and non-carcinogenic feed-stock) is low with no observed mortalities from oral or dermal applications. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3be3d5b1-8c28-4833-8f12-184100735862/documents/487cb143-84ad-42d7-9af4-e03f57e30851_66ce0fd9-a37f-4290-84d0-cc4af9071ffa.html,,,,,, Petrolatum,8009-03-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3be3d5b1-8c28-4833-8f12-184100735862/documents/487cb143-84ad-42d7-9af4-e03f57e30851_66ce0fd9-a37f-4290-84d0-cc4af9071ffa.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Petrolatum,8009-03-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3be3d5b1-8c28-4833-8f12-184100735862/documents/487cb143-84ad-42d7-9af4-e03f57e30851_66ce0fd9-a37f-4290-84d0-cc4af9071ffa.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Phenacetin,62-44-2,"Supporting study: A repeated dose toxicity study of 4 weeks in rats was conducted on the test item and LOEL observed was 500 mg/kg bw/day, based on haematological findings. Supporting study: A repeated dose toxicity study of 66 weeks in rats was conducted on the test item and MTD observed was 450 mg/kg bw/day. Based on a significant decrease of renal concentrating capacity and this impairment tended to be rapidly reversible after discontinuation administration of the test item. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0262e132-9342-417c-8f45-0a69f6a68305/documents/4630dbd5-e9f3-45cd-aa17-3692ad302ea4_f213d484-06c4-493b-820d-31acb9e5f049.html,,,,,, Phenacetin,62-44-2,"Key study: Acute oral toxicity. The LD50 value of the test item is 1650 mg/ kg body weight by oral route in rat. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study has a Klimisch score of 2. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0262e132-9342-417c-8f45-0a69f6a68305/documents/d76117b5-5448-4907-b66d-cc556f29c9a3_f213d484-06c4-493b-820d-31acb9e5f049.html,,,,,, Phenacetin,62-44-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0262e132-9342-417c-8f45-0a69f6a68305/documents/d76117b5-5448-4907-b66d-cc556f29c9a3_f213d484-06c4-493b-820d-31acb9e5f049.html,,oral,LD50,"1,650 mg/kg bw",adverse effect observed, Phenethyl acetate,103-45-7,Oral repeated dose toxicity studies are available using rats and mice as the test species.  The studies were conducted for a period of 14 days or 13 weeks.  There is no indication that the studies conformed to guidelines or were GLP compliant.  The NOAEL derived for subchronic exposure to rats was 250 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1aa13d04-45be-4958-bc13-a1bce8bd7640/documents/744322a4-b5be-4eb2-8228-a57b2f4a4a2c_f17e6d8f-5687-4130-8f6c-b55827aab3b2.html,,,,,, Phenethyl acetate,103-45-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1aa13d04-45be-4958-bc13-a1bce8bd7640/documents/744322a4-b5be-4eb2-8228-a57b2f4a4a2c_f17e6d8f-5687-4130-8f6c-b55827aab3b2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Phenethyl acetate,103-45-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Two studies are avaialble and report low acute oral toxicity; studies report limited methodology but are sufficient for the purposes of hazard identification and classification Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Guideline-comparable study for a read-across substance Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Study uses high dose levels but is adequate for the purposes of classification ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aa13d04-45be-4958-bc13-a1bce8bd7640/documents/5f4bad5a-af34-4f42-b7ea-0187fc61b9da_f17e6d8f-5687-4130-8f6c-b55827aab3b2.html,,,,,, Phenethyl acetate,103-45-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aa13d04-45be-4958-bc13-a1bce8bd7640/documents/5f4bad5a-af34-4f42-b7ea-0187fc61b9da_f17e6d8f-5687-4130-8f6c-b55827aab3b2.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Phenethyl acetate,103-45-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aa13d04-45be-4958-bc13-a1bce8bd7640/documents/5f4bad5a-af34-4f42-b7ea-0187fc61b9da_f17e6d8f-5687-4130-8f6c-b55827aab3b2.html,,dermal,LD50,"6,210 mg/kg bw",adverse effect observed, Phenethyl acetate,103-45-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aa13d04-45be-4958-bc13-a1bce8bd7640/documents/5f4bad5a-af34-4f42-b7ea-0187fc61b9da_f17e6d8f-5687-4130-8f6c-b55827aab3b2.html,,inhalation,LC50,766 mg/m3,no adverse effect observed, 2-phenylethanol,60-12-8,"A 90 day toxicity study with Phenyl ethyl alcohol was performed by dermal route using male and female rats. The NOAEL (based on significant reductions in body weight, with haematological and organ weight effects at higher treatment levels) is 0.5 ml/kg bw/day, equivalent to 510 mg/kg bw/d. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72549c8b-c16d-4cac-b759-95ccd9aa58d3/documents/38744c10-4018-4ae3-b35b-81436e63d08b_097bf2a9-3b4a-491e-9859-69a7c86803c7.html,,,,,, 2-phenylethanol,60-12-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72549c8b-c16d-4cac-b759-95ccd9aa58d3/documents/38744c10-4018-4ae3-b35b-81436e63d08b_097bf2a9-3b4a-491e-9859-69a7c86803c7.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,510 mg/kg bw/day,,rat 2-phenylethanol,60-12-8,Acutely hazardous after ingestion but not following skin contact. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72549c8b-c16d-4cac-b759-95ccd9aa58d3/documents/0d4c3315-35c8-4c94-aa1b-61c3272c8173_097bf2a9-3b4a-491e-9859-69a7c86803c7.html,,,,,, 2-phenylethanol,60-12-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72549c8b-c16d-4cac-b759-95ccd9aa58d3/documents/0d4c3315-35c8-4c94-aa1b-61c3272c8173_097bf2a9-3b4a-491e-9859-69a7c86803c7.html,,oral,LD50,"1,603 mg/kg bw",adverse effect observed, 2-phenylethanol,60-12-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72549c8b-c16d-4cac-b759-95ccd9aa58d3/documents/0d4c3315-35c8-4c94-aa1b-61c3272c8173_097bf2a9-3b4a-491e-9859-69a7c86803c7.html,,dermal,LD50,"2,535 mg/kg bw",no adverse effect observed, Phenethyl benzoate,94-47-3,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyInformation.KeyInformation): Repeated Dose (Oral) Toxicity Study: In the OECD 422 study with the substance (rats; oral gavage), NOAEL for systemic toxicity was determined to be 1000 mg/kg bw/day in both genders. The study was performed according to GLP and was considered to be reliable without restrictions (Klimisch 1).   Repeated Dose (Dermal) Toxicity Study: A short-term dermal toxicity study does not need to be conducted because exposure of humans via dermal route in production and/or use is unlikely based on the provided thorough and rigorous exposure assessment. Also, the acute dermal toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Therefore, it is expected that test chemical shall not exhibit toxicity via dermal route following exposure for 28 days. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route and therefore this end point was considered for waiver.   Repeated Dose (Inhalation) Toxicity: A short-term inhalation toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the given test chemical has very low vapor pressure, < 0.1333 Pa at 20°C, so the potential for the generation of inhalable vapor is very low. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be highly unlikely and therefore the end point of repeated inhalation toxicity was considered for waiver.Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch 1. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de5a78cc-248c-4acc-85c5-4c7afe661505/documents/5caa106f-2a3b-4d8e-8c5e-8a75100dad63_b531cc6d-b43b-4b9c-be0d-84f1db3e7488.html,,,,,, Phenethyl benzoate,94-47-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de5a78cc-248c-4acc-85c5-4c7afe661505/documents/5caa106f-2a3b-4d8e-8c5e-8a75100dad63_b531cc6d-b43b-4b9c-be0d-84f1db3e7488.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Phenethyl benzoate,94-47-3," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical.The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity.Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.  Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0147 Pa = 0.00011 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that the LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de5a78cc-248c-4acc-85c5-4c7afe661505/documents/7c58f216-5ffa-4683-9a71-47c0a614d84c_b531cc6d-b43b-4b9c-be0d-84f1db3e7488.html,,,,,, Phenethyl benzoate,94-47-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de5a78cc-248c-4acc-85c5-4c7afe661505/documents/7c58f216-5ffa-4683-9a71-47c0a614d84c_b531cc6d-b43b-4b9c-be0d-84f1db3e7488.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Phenethyl benzoate,94-47-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de5a78cc-248c-4acc-85c5-4c7afe661505/documents/7c58f216-5ffa-4683-9a71-47c0a614d84c_b531cc6d-b43b-4b9c-be0d-84f1db3e7488.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Phenethyl butyrate,103-52-6," Repeated dose toxicity oral: The No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg bw/day when rats were exposed to the test chemical orally. Repeated dose toxicity: Inhalation The repeated dose inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.00859 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study for repeated dose toxicity by inhalation route of exposure is considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value for phenethyl butyrate (CAS no 103-52 -6) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/696b3b80-483b-429a-9cfc-ec5e5333b208/documents/d88e5642-2466-4dac-908e-2616e15409f0_f2d763ca-8814-48a4-8724-931ea1a74e17.html,,,,,, Phenethyl butyrate,103-52-6,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/696b3b80-483b-429a-9cfc-ec5e5333b208/documents/d88e5642-2466-4dac-908e-2616e15409f0_f2d763ca-8814-48a4-8724-931ea1a74e17.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Phenethyl butyrate,103-52-6," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: Test chemicalhas very low vapour pressure (11.45 Pa.= 0.00859 mmHg),So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver.   Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/696b3b80-483b-429a-9cfc-ec5e5333b208/documents/c75e4d57-a25f-453d-ac88-a79b289eaa1e_f2d763ca-8814-48a4-8724-931ea1a74e17.html,,,,,, Phenethyl butyrate,103-52-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/696b3b80-483b-429a-9cfc-ec5e5333b208/documents/c75e4d57-a25f-453d-ac88-a79b289eaa1e_f2d763ca-8814-48a4-8724-931ea1a74e17.html,,oral,LD50,"4,600 mg/kg bw",no adverse effect observed, Phenethyl butyrate,103-52-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/696b3b80-483b-429a-9cfc-ec5e5333b208/documents/c75e4d57-a25f-453d-ac88-a79b289eaa1e_f2d763ca-8814-48a4-8724-931ea1a74e17.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Phenethyl cinnamate,103-53-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/adf0c8a7-8278-4d8b-a0b5-340734454d58/documents/IUC5-d41c79d3-56b2-4db6-b4c6-3cabf07910d3_da0a7516-a240-45d3-bc83-3d0cf412d939.html,,oral,LD50,"4,500 mg/kg bw",adverse effect observed, Phenethyl isobutyrate,103-48-0," Based on results of an OECD 422 and GLP compliant study, the toxicological NOAEL for daily oral gavage of the test item in male and female rats for 28 consecutive days was found to be 300 mg/kg bw/d. Dose levels of 100, 300 or 1000 mg/kg bw/day were applied. Effects of general toxicity were observed at the High dose only and were completely reversible within the recovery period. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6e048b3-5317-4616-ab95-8e539814e05b/documents/2421a807-9fd6-4482-9506-39c4e0084b9d_8801a754-4e7a-4551-baf6-be7c5d542c5a.html,,,,,, Phenethyl isobutyrate,103-48-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6e048b3-5317-4616-ab95-8e539814e05b/documents/2421a807-9fd6-4482-9506-39c4e0084b9d_8801a754-4e7a-4551-baf6-be7c5d542c5a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Phenethyl isobutyrate,103-48-0, Oral: The oral LD50 value for the test substance was found to be 5000 mg/kg bw. Dermal: The dermal LD50 value for the test substance was found to be greater than 5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6e048b3-5317-4616-ab95-8e539814e05b/documents/2bc360db-ab50-409b-ab29-1525de9e7cf9_8801a754-4e7a-4551-baf6-be7c5d542c5a.html,,,,,, Phenethyl isobutyrate,103-48-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6e048b3-5317-4616-ab95-8e539814e05b/documents/2bc360db-ab50-409b-ab29-1525de9e7cf9_8801a754-4e7a-4551-baf6-be7c5d542c5a.html,,oral,LD50,"5,000 mg/kg bw",adverse effect observed, Phenethyl isobutyrate,103-48-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6e048b3-5317-4616-ab95-8e539814e05b/documents/2bc360db-ab50-409b-ab29-1525de9e7cf9_8801a754-4e7a-4551-baf6-be7c5d542c5a.html,,dermal,LD50,"5,000 mg/kg bw",adverse effect observed, Phenethyl isovalerate,140-26-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Prediction model based estimation ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7f3a4d9-6c1d-4602-a7bc-70bf893ec4f2/documents/IUC5-8d436bb1-cf74-4858-84b7-2e0ee8a6d4a4_bc1e4f4a-9cc5-4d60-803d-2c63e1e26f67.html,,,,,, Phenethyl isovalerate,140-26-1,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7f3a4d9-6c1d-4602-a7bc-70bf893ec4f2/documents/IUC5-8d436bb1-cf74-4858-84b7-2e0ee8a6d4a4_bc1e4f4a-9cc5-4d60-803d-2c63e1e26f67.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,870 mg/kg bw/day,,rat Phenethyl isovalerate,140-26-1,LD50 was estimated to be 2283.036865234 mg/kg bw on white rat for substance Phenethyl isovalerate. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7f3a4d9-6c1d-4602-a7bc-70bf893ec4f2/documents/IUC5-0e85ab2e-7b95-4b87-b6ab-0a69bfa75fbd_bc1e4f4a-9cc5-4d60-803d-2c63e1e26f67.html,,,,,, Phenethyl isovalerate,140-26-1,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7f3a4d9-6c1d-4602-a7bc-70bf893ec4f2/documents/IUC5-0e85ab2e-7b95-4b87-b6ab-0a69bfa75fbd_bc1e4f4a-9cc5-4d60-803d-2c63e1e26f67.html,,oral,LD50,"2,283.037 mg/kg bw",no adverse effect observed, Phenethyl isovalerate,140-26-1,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7f3a4d9-6c1d-4602-a7bc-70bf893ec4f2/documents/IUC5-0e85ab2e-7b95-4b87-b6ab-0a69bfa75fbd_bc1e4f4a-9cc5-4d60-803d-2c63e1e26f67.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Phenethyl phenylacetate,102-20-5,"Repeated Dose Oral Toxicity: Repeated dose oral study for test chemical was assessed for its possible toxic potential. Groups of 10 male and 10 female Osbourne-Mendel rats were provided test chemical mixed in the diet at concentrations of 0, 1000, 2500 or 10,000 ppm which corresponding to an average daily intakes of 0, 50, 250, or 500 mg/kg bw per for 17 weeks. At termination, hematological examinations revealed no effects due to administration of the test chemical. At necropsy, no differences were reported in major organ weights between test and control animals. Gross examination of tissue of all animals was unremarkable and histopathological examination of six-eight animals, equally represented by gender, for the high-dose group and the control group revealed no treatment-related lesions. Hence, the highest dose tested i.e 500 mg/kg/day can be considered as the NOAEL. Repeated dose toxicity: Inhalation The short term toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical. The experimental vapour pressure was 0.0248Pa at 20 deg C. Also, the LC50 was considered to be >5500 mg/m3, when rats were exposed to the test chemical by inhalation route for 4 hours. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore, this study is considered for waiver Repeated dose toxicity: dermal A short-term repeated dose dermal toxicity study need not be conducted because exposure of humans via dermal route in production and/or in use is highly unlikely based on the thorough and rigorous risk assessment provided. Also, the acute dermal toxicity LD50 value for the test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. The test chemical was also found to be not sensitizing to the skin. Considering this, the end point for repeated dermal toxicity is considered as waiver.      ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0fa495cb-3846-446b-a88c-ff5364d2e271/documents/b6cc3466-d2c8-4203-a7a7-66b719514268_d1f885cc-3754-44ed-914b-4d6fff5ca8fe.html,,,,,, Phenethyl phenylacetate,102-20-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0fa495cb-3846-446b-a88c-ff5364d2e271/documents/b6cc3466-d2c8-4203-a7a7-66b719514268_d1f885cc-3754-44ed-914b-4d6fff5ca8fe.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Phenethyl phenylacetate,102-20-5," Acute Toxicity: Oral Acute Oral Toxicity Study of the test chemical was conducted as per OECD 423 Guidelines in rats. Six female Wistar rats were selected for acute oral toxicity study. No external and internal gross pathological changes were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice. Under the conditions of this acute oral toxicity study, the acute oral LD50 value was greater than 2000 mg/kg. Hence, the test chemical can be classified under the category ""Not Classified"" as per CLP Regulation. Acute Toxicity: Inhalation The acute inhalation study of test chemical was conducted in Wistar rats. The study was performed according to OECD-Guideline -403. The necropsy performed on all the animals at the termination of study did not show any gross pathological changes. The acute inhalation toxicity dose (LC50) was considered to be >5 mg/L (>5000 mg/m3), when male and female Wistar rats were exposed with the test chemical via inhalation route by nose only exposure for 4 hours. Hence the test chemical can be classified under the category “Not Classified” as per CLP Regulation. Acute Toxicity: Dermal Acute dermal toxicity study for the test chemical was conducted as per OECD No. 402 in Wistar Rats. Five male and five female healthy young adult rats were randomly selected and used for conducting acute dermal toxicity study. The external and internal gross pathological observation of all terminally sacrificed animals did not show any pathological abnormality. Under the conditions of the study, the acute dermal toxicity dose (LD50) was considered to be >2000 mg/kg bw, when rats were treated with the test chemical by dermal application. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fa495cb-3846-446b-a88c-ff5364d2e271/documents/9acb1cfa-a02c-40df-ac75-5343a078406b_d1f885cc-3754-44ed-914b-4d6fff5ca8fe.html,,,,,, Phenethyl phenylacetate,102-20-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fa495cb-3846-446b-a88c-ff5364d2e271/documents/9acb1cfa-a02c-40df-ac75-5343a078406b_d1f885cc-3754-44ed-914b-4d6fff5ca8fe.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Phenethyl phenylacetate,102-20-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fa495cb-3846-446b-a88c-ff5364d2e271/documents/9acb1cfa-a02c-40df-ac75-5343a078406b_d1f885cc-3754-44ed-914b-4d6fff5ca8fe.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Phenethyl phenylacetate,102-20-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fa495cb-3846-446b-a88c-ff5364d2e271/documents/9acb1cfa-a02c-40df-ac75-5343a078406b_d1f885cc-3754-44ed-914b-4d6fff5ca8fe.html,,inhalation,LC50,"> 5,000 mg/m3",no adverse effect observed, Phenethyl pivalate,67662-96-8,"The oral LD50 of the test item, Fenethylpivalinate, is higher than 5000 ml/kg bw in rats therefore it is not classified according to the Annex VI to the Directive 67/548/EEC and the CLP Regulation (EC) N° (1272-2008). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6688f83-89db-4424-9329-18e8bcd1b539/documents/IUC5-20b492f2-65f2-446c-ac00-ac6159ed9e32_506167a7-05f2-4bdc-abb5-4074eeba0b17.html,,,,,, Phenethyl pivalate,67662-96-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6688f83-89db-4424-9329-18e8bcd1b539/documents/IUC5-20b492f2-65f2-446c-ac00-ac6159ed9e32_506167a7-05f2-4bdc-abb5-4074eeba0b17.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Phenethyl propionate,122-70-3, Acute toxicity: oral The acute oral median lethal dose (LD50) of phenethyl propionate in rat was observed to be 4000.0 mg/kg b.wt with 95% confidence limit of 2630 – 5370 mg/kg. Acute toxicity: dermal The acute dermal median lethal dose (LD50) of phenethyl propionate in rabbit was observed to be greater than 5000.0 mg/kg b.wt (>5000 mg/kg bw). ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6778cbb1-ef60-4528-b7c7-ed6922b6336b/documents/f4b406f7-53a8-499f-9752-7a12ff1fc4b7_02716580-974e-42a3-a5c1-830d27f8f782.html,,,,,, Phenethyl propionate,122-70-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6778cbb1-ef60-4528-b7c7-ed6922b6336b/documents/f4b406f7-53a8-499f-9752-7a12ff1fc4b7_02716580-974e-42a3-a5c1-830d27f8f782.html,,oral,LD50,"4,000 mg/kg bw",no adverse effect observed, Phenethyl propionate,122-70-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6778cbb1-ef60-4528-b7c7-ed6922b6336b/documents/f4b406f7-53a8-499f-9752-7a12ff1fc4b7_02716580-974e-42a3-a5c1-830d27f8f782.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Phenethyl salicylate,87-22-9,"Acute toxicity- ORAL In an acute oral toxicity study, the acute oral LD50 of the test chemical was determined in 10 rats. The rats were observed for mortality and/or systemic effects for 14 days. Slight lethargy was observed during the course of the study. The LD50 exceeded 5 g/kg based on one (1/10) death at that dose. Thus, based on all the observations and results, it was concluded that the test chemical is not acutely toxic to the rats when administered at 5000 mg/kg bw.   Acute toxicity- Dermal An acute dermal toxicity study was performed to evaluate the toxic potential of the test chemical in rabbits. Nine rabbits received a single dermal application of neat test chemical at a dose of 5 g/kg. The rabbits were observed for mortality and/or systemic effects for 14 days. No clinical signs or mortality were observed. Thus, based on all the observations and results, it was concluded that the LD50 of the test chemical was observed to be >5000 mg/kg bw.   Acute toxicity- Inhalation The study doesnot need to be conducted because exposure of humans via inhalation route is not likely taking into account the vapor pressure of the substance and/or the possibility of exposure to aerosols, particles, or droplets of an inhalable size. The test chemical has very low vapor pressure < 0.1333 Pa at 20°C., so the potential for the generation of inhalable vapors is very low. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad32c6ba-a597-444c-8f36-b965c292a340/documents/edc2dbca-a987-4622-adfa-4509b378bc2f_9b94eccf-9bdd-4990-b289-b01592887c95.html,,,,,, Phenethyl salicylate,87-22-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad32c6ba-a597-444c-8f36-b965c292a340/documents/edc2dbca-a987-4622-adfa-4509b378bc2f_9b94eccf-9bdd-4990-b289-b01592887c95.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Phenethyl salicylate,87-22-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad32c6ba-a597-444c-8f36-b965c292a340/documents/edc2dbca-a987-4622-adfa-4509b378bc2f_9b94eccf-9bdd-4990-b289-b01592887c95.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Phenol,108-95-2,"Oral exposure NOAEL = 300 mg/kg bw/day, systemic effects in ratsIn a two generation drinking water reproductive toxicity study no relevant effects were observed up to 300 mg/kg bw in rats exposed over approx. 13 weeks. The NOAEL from a long-term drinking water (2a) study is 370 mg/kg bw/d in mice. Lower NOEL from 13 weeks study was not considered for risk assessment, as it is related to secondary effects due to reduced water and/or food intake.Dermal exposure NOAEL =130 mg/kg bw/day systemic effects in rabbitsNOAEC = 2.37%, local effects in rabbitsIn the dermal study conducted by Deichmann et al. (1950) rabbits showed local effects at a concentration of 3.56% and neurobehavioral effects (tremor) after repeated exposure to 260 mg/kg bw/day. The NOAEL was 130 mg/kg bw/day. The validity of this study concerning systemic effects is limited. Inhalation exposure NOAEC = 20 mg/m³, systemic effects in monkeys In a continuous inhalation study with rhesus monkeys, rats and mice no significant pathological effects were reported at 5 ppm (20 mg/m³) for 90 d. No adverse effects were reported in a valid 14 day-inhalation study in rats (Hoffman et al., 2001). The NOAEC for local and systemic effects was 96 mg/m³. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05f8bed3-8538-4e5f-8904-07da03c942f0/documents/IUC5-a23da675-fb4f-40dd-ba52-861ffe3112f9_9955b248-829b-4b1c-a04d-e42c692db216.html,,,,,, Phenol,108-95-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05f8bed3-8538-4e5f-8904-07da03c942f0/documents/IUC5-a23da675-fb4f-40dd-ba52-861ffe3112f9_9955b248-829b-4b1c-a04d-e42c692db216.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,130 mg/kg bw/day,,rabbit Phenol,108-95-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05f8bed3-8538-4e5f-8904-07da03c942f0/documents/IUC5-a23da675-fb4f-40dd-ba52-861ffe3112f9_9955b248-829b-4b1c-a04d-e42c692db216.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Phenol,108-95-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05f8bed3-8538-4e5f-8904-07da03c942f0/documents/IUC5-a23da675-fb4f-40dd-ba52-861ffe3112f9_9955b248-829b-4b1c-a04d-e42c692db216.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,20 mg/m3,,monkey Phenol,108-95-2,"In humans and experimental animals the signs and symptoms of acute toxicity are similar regardless of the route of administration (compare also with data presented in the Summary of Section 7.1). Beside the concentration dependent local effects (corrosive properties of phenol) also systemic effects are obvious. Muscle weakness, convulsions, and coma are the predominant symptoms associated with exposure to lethal concentrations of phenol. Regardless of the route of exposure, absorption is rapid, as illustrated by the fact that acute doses of phenol can produce symptoms of toxicity within minutes after administration. For animals, dermal and oral LD50 values are reported in the literature falling within one order of magnitude: oral LD50 in rats 340 -650 mg/kg bw and dermal LD50 in rats 660 (525 -707) mg/kg bw and in rabbits 850 mg/kg bw. Although LC50 values are not available in literature, rats are reported to have tolerated phenol concentrations as high as 236 ppm (900 mg/m³) for 8 hours, resulting in ocular and nasal irritation, loss of coordination. The odour recognition threshold (100% response) of phenol in humans is approximately 0.05 ppm, a concentration far below the levels where toxic effects have been reported; thus, the chemical has good warning properties for inhalation exposure. Oral toxicity of phenol in humans leading to the death of the victim is reported for doses as low as 140-290 mg/kg body weight. Absorption from spilling phenolic solutions on the skin of humans may be very rapid, and death results from collapse within 30 minutes to several hours. Death has resulted from absorption of phenol through a skin area of 64 inch². Based on these data phenol has been classified as “toxic” and labelled with “R 23/24/25 (Toxic by inhalation, in contact with skin and if swallowed)”. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05f8bed3-8538-4e5f-8904-07da03c942f0/documents/IUC5-0222be46-22d8-479b-a087-7f66223e1eac_9955b248-829b-4b1c-a04d-e42c692db216.html,,,,,, Phenol,108-95-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05f8bed3-8538-4e5f-8904-07da03c942f0/documents/IUC5-0222be46-22d8-479b-a087-7f66223e1eac_9955b248-829b-4b1c-a04d-e42c692db216.html,,oral,LD50,340 mg/kg bw,, Phenol,108-95-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05f8bed3-8538-4e5f-8904-07da03c942f0/documents/IUC5-0222be46-22d8-479b-a087-7f66223e1eac_9955b248-829b-4b1c-a04d-e42c692db216.html,,dermal,LD50,660 mg/kg bw,, Phenolphthalein,77-09-8," A study similar to OECD TG 408 was performed to assess the cumulative toxicity of the test item. Groups of 10 male and 9 or 10 female F344/N rats were given 0, 3000, 6000, 12000, 25000, or 50000 ppm test item (equivalent to average daily doses of approximately 200, 400, 800, 1600, or 3500 mg test item/kg body weight to males and 200, 400, 800, 1700, or 3600 mg/kg to females) in feed for 13 weeks. Based on the results of this study, the NOAEL was 800 mg/kg bw/day for males and females (reference 7.5.1-1). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acfbbfea-c389-42f3-bddc-a1142c8d147f/documents/1e559d8f-eaca-4dc8-a68f-78bbc6b21b57_52c14038-7e0f-4bf5-8f74-aed93163331a.html,,,,,, Phenolphthalein,77-09-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acfbbfea-c389-42f3-bddc-a1142c8d147f/documents/1e559d8f-eaca-4dc8-a68f-78bbc6b21b57_52c14038-7e0f-4bf5-8f74-aed93163331a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,800 mg/kg bw/day,,rat Phenolphthalein,77-09-8, The test item does not possess any acute toxic potential below 2000 mg/kg bw (reference 7.2.1 -1). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acfbbfea-c389-42f3-bddc-a1142c8d147f/documents/62de7466-fa46-4117-975f-e6abc73fa141_52c14038-7e0f-4bf5-8f74-aed93163331a.html,,,,,, Phenolphthalein,77-09-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acfbbfea-c389-42f3-bddc-a1142c8d147f/documents/62de7466-fa46-4117-975f-e6abc73fa141_52c14038-7e0f-4bf5-8f74-aed93163331a.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, 2-phenoxyethanol,122-99-6,"Several repeated oral dose toxicity studies were available. The benchmark dose method was used to derive a BMDL10. The most critical effect was determined to be the renal hyperplasia in male rats. Combining the subchronic and chronic studies in rats a BMDL10 of 369 mg/kg bw/day has been derived.In a 90-day repeated-dose dermal toxicity study in white rabbits toxicologically non relevant effects were observed. Therefore the highest dose tested (500 mg/kg bw/day) was designated as the NOAEL for systemic toxicity. In a 14-day inhalation study with rats pathological examinations revealed no treatment-related changes in either males or females. Morphological changes indicating irritation were found in nasal cavity, larynx and lung of male and female mid- and high-concentration animals. A NOAEC of 48.2mg/m³ was determined. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b8173c2f-068b-48df-a135-1f06cdc7ac3b/documents/IUC5-d2707e04-a19d-462b-96b4-0572e78a6ab1_7c454dd1-978d-4a45-81fa-e8beec11cab8.html,,,,,, 2-phenoxyethanol,122-99-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b8173c2f-068b-48df-a135-1f06cdc7ac3b/documents/IUC5-d2707e04-a19d-462b-96b4-0572e78a6ab1_7c454dd1-978d-4a45-81fa-e8beec11cab8.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,48.2 mg/m3,,rat 2-phenoxyethanol,122-99-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b8173c2f-068b-48df-a135-1f06cdc7ac3b/documents/IUC5-d2707e04-a19d-462b-96b4-0572e78a6ab1_7c454dd1-978d-4a45-81fa-e8beec11cab8.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rabbit 2-phenoxyethanol,122-99-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b8173c2f-068b-48df-a135-1f06cdc7ac3b/documents/IUC5-d2707e04-a19d-462b-96b4-0572e78a6ab1_7c454dd1-978d-4a45-81fa-e8beec11cab8.html,Chronic toxicity – systemic effects,oral,BMDL10,369 mg/kg bw/day,,rat 2-phenoxyethanol,122-99-6,2-Phenoxyethanol displayed low acute oral toxicity in rats.2-Phenoxyethanol displayed very low acute dermal toxicity tested in rats and rabbits.2-Phenoxyethanol displayed no effects following inhalation exposure in rats. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8173c2f-068b-48df-a135-1f06cdc7ac3b/documents/IUC5-4167422a-b64c-4821-8a53-2c1f771f1a83_7c454dd1-978d-4a45-81fa-e8beec11cab8.html,,,,,, 2-phenoxyethanol,122-99-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8173c2f-068b-48df-a135-1f06cdc7ac3b/documents/IUC5-4167422a-b64c-4821-8a53-2c1f771f1a83_7c454dd1-978d-4a45-81fa-e8beec11cab8.html,,oral,LD50,"1,840 mg/kg bw",adverse effect observed, 2-phenoxyethanol,122-99-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8173c2f-068b-48df-a135-1f06cdc7ac3b/documents/IUC5-4167422a-b64c-4821-8a53-2c1f771f1a83_7c454dd1-978d-4a45-81fa-e8beec11cab8.html,,dermal,discriminating dose,"2,214 mg/kg bw",no adverse effect observed, 2-phenoxyethanol,122-99-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8173c2f-068b-48df-a135-1f06cdc7ac3b/documents/IUC5-4167422a-b64c-4821-8a53-2c1f771f1a83_7c454dd1-978d-4a45-81fa-e8beec11cab8.html,,inhalation,discriminating conc.,"1,000 mg/m3",no adverse effect observed, 2-phenoxyethyl acrylate,48145-04-6," From an OECD 422 screening study, an oral NOAEL in relation to systemic efects was established to 300 mg/kg bw/day based on increase in liver weights in both sexes (and increased kidney weight in males) at 800 mg/kg/d. For local effects in the forestomach an oral NOAEL of 100 mg/kg bw/day was established. In an OECD Guideline 408 study, Wistar rats (10 animals per sex/ dose level) were dosed by gavage during 90 days at levels of 0, 30, 100 and 350 mg/kg/day. No unscheduled deaths occurred, and there were no toxicological findings in relation to clinical observation or pathological findings.Salivation at the dose level of 350 mg/kg/day was considered as a test item palatability response and only slight differences in clinical laboratory investigations and some slight changes in organ weights at the high dose level were noted. Under the conditions of this study the dose of 350 mg/kg/day is to be considered as a NOAEL both in relation to systemic effects as well as local effects. It is to be noted that 350 mg/kg bw/day was selected as the highest dose level for the study as inflammatory infiltrates in submucosa and forestomach ulcerations was observed at dose levels of 300 mg/kg bw/day and 800 mg/kg bw/day in the OECD 422 study. Thus, for longer term exposure an adaptation to the gastric irritational effects seems to occur as such effects were not observed in this 90D study at 350 mg/kg/d. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ebc98d7-b473-48d0-9d4b-22faaad5c0f5/documents/IUC5-d6a63de9-e908-4fb3-838d-f2e5013ec508_8ffbc7fe-23a9-45a3-8685-0ae3aff27f73.html,,,,,, 2-phenoxyethyl acrylate,48145-04-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ebc98d7-b473-48d0-9d4b-22faaad5c0f5/documents/IUC5-d6a63de9-e908-4fb3-838d-f2e5013ec508_8ffbc7fe-23a9-45a3-8685-0ae3aff27f73.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,350 mg/kg bw/day,,rat 2-phenoxyethyl acrylate,48145-04-6, 2-phenoxyethyl acrylate demonstrate a low acute oral and dermal toxicity. No conclusive inhalation study is available. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ebc98d7-b473-48d0-9d4b-22faaad5c0f5/documents/IUC5-5692046f-e42e-4f19-885c-292d410415ec_8ffbc7fe-23a9-45a3-8685-0ae3aff27f73.html,,,,,, 2-phenoxyethyl acrylate,48145-04-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ebc98d7-b473-48d0-9d4b-22faaad5c0f5/documents/IUC5-5692046f-e42e-4f19-885c-292d410415ec_8ffbc7fe-23a9-45a3-8685-0ae3aff27f73.html,,oral,discriminating dose,"5,000 mg/kg bw",adverse effect observed, 2-phenoxyethyl acrylate,48145-04-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ebc98d7-b473-48d0-9d4b-22faaad5c0f5/documents/IUC5-5692046f-e42e-4f19-885c-292d410415ec_8ffbc7fe-23a9-45a3-8685-0ae3aff27f73.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Octanoic acid, 2-phenoxyethyl ester",23511-73-1," Repeated dose toxicity (oral, OECD 407): NOAEL = 1000 mg/kg bw/day (male/female) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33fc17ec-c1fb-40f8-931f-10e858beb868/documents/b558ac5d-f24f-46da-822f-4f4c78e74c2c_e1ddf865-6606-4f8f-a36e-53a73f13d906.html,,,,,, "Octanoic acid, 2-phenoxyethyl ester",23511-73-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33fc17ec-c1fb-40f8-931f-10e858beb868/documents/b558ac5d-f24f-46da-822f-4f4c78e74c2c_e1ddf865-6606-4f8f-a36e-53a73f13d906.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Octanoic acid, 2-phenoxyethyl ester",23511-73-1," Acute toxicity, oral (OECD 423), female rats: LD50 > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33fc17ec-c1fb-40f8-931f-10e858beb868/documents/3222cc8e-4acf-460d-9084-ea7131fce170_e1ddf865-6606-4f8f-a36e-53a73f13d906.html,,,,,, 2-phenoxyethyl isobutyrate,103-60-6,"Dermal NOAEL > 1000 mg/kg bw/day, 90 days rat male/female, methodolgy similar to OECD 411, Mulhern et al. (1990). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ddd6eb4-39ff-4a0f-9e65-ab5890b973d2/documents/IUC5-4adfd9b2-25c2-4e45-9c48-38df736c1385_bb21ecec-74ef-4c37-aa6c-a7ea1befdbaa.html,,,,,, 2-phenoxyethyl isobutyrate,103-60-6,"Oral: LD50 between 2060 and 5015 mg/kg bw, male/female mice, Smith (1979).Dermal: LD50 > 2000 mg/kg bw, male/female rat,  OECD 402, EU Method B.3, Sanders (2012). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ddd6eb4-39ff-4a0f-9e65-ab5890b973d2/documents/IUC5-171eed43-3005-4941-8842-4a226fb195b6_bb21ecec-74ef-4c37-aa6c-a7ea1befdbaa.html,,,,,, 2-phenoxyethyl methacrylate,10595-06-9," Oral exposure:   No data is available on 2-phenoxyethyl methacrylate (T). From an OECD 422 screening study, an oral NOAEL in relation to systemic efects was established to 300 mg/kg bw/day based on increase in liver weights in both sexes (and increased kidney weight in males) at 800 mg/kg/d. For local effects in the forestomach an oral NOAEL of 100 mg/kg bw/day was established.   In an OECD Guideline 408 study, Wistar rats (10 animals per sex/ dose level) were dosed by gavage during 90 days at levels of 0, 30, 100 and 350 mg/kg/day. No unscheduled deaths occurred, and there were no toxicological findings in relation to clinical observation or pathological findings.Salivation at the dose level of 350 mg/kg/day was considered as a test item palatability response and only slight differences in clinical laboratory investigations and some slight changes in organ weights at the high dose level were noted. Under the conditions of this study the dose of 350 mg/kg/day is to be considered as a NOAEL both in relation to systemic effects as well as local effects.   It is to be noted that 350 mg/kg bw/day was selected as the highest dose level for the study as inflammatory infiltrates in submucosa and forestomach ulcerations was observed at dose levels of 300 mg/kg bw/day and 800 mg/kg bw/day in the OECD 422 study. Thus, for longer term exposure an adaptation to the gastric irritational effects seems to occur as such effects were not observed in this 90D study at 350 mg/kg/d.   Based on read-across the same NOAEL values 350 mg/kg bw/day (systemic) and 100 mg/kg bw/day (local) for repeated dose toxicity should apply for 2-phenoxyethyl methacrylate.   Dermal exposure No data is available on either 2-phenoxyethyl methacrylate or 2-phenoxyethyl acrylate.   Inhalation No data is available on either 2-phenoxyethyl methacrylate or 2-phenoxyethyl acrylate ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04097175-7e3a-4106-b20e-e134dd84e8e3/documents/739f299b-b16d-4ff2-a6a9-6e3a394c22c0_84838546-a307-4494-8da3-adb728e0fbf6.html,,,,,, 2-phenoxyethyl methacrylate,10595-06-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04097175-7e3a-4106-b20e-e134dd84e8e3/documents/739f299b-b16d-4ff2-a6a9-6e3a394c22c0_84838546-a307-4494-8da3-adb728e0fbf6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,350 mg/kg bw/day,,rat 2-phenoxyethyl methacrylate,10595-06-9," No data is available on 2-phenoxyethyl methacrylate. The available studies on acute oral and acute dermal toxicity of 2-phenoxyethyl acrylate (S1) show that the substance has low acute toxicity with an oral LD50 in rats > 5000 mg/kg, and low dermal toxicity with an dermal LD50 in rats > 2000 mg/kg bw. These values are considered relevant for 2-phenoxyethyl methacrylate (T) as well. No data is available on inhalation toxicity on neither2-phenoxyethyl methacrylate nor 2-phenoxyethyl acrylate. See further read-across justification in document attached in section 13. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04097175-7e3a-4106-b20e-e134dd84e8e3/documents/7c853d04-30e4-4f1f-aee5-27d38a529b96_84838546-a307-4494-8da3-adb728e0fbf6.html,,,,,, 2-phenoxyethyl methacrylate,10595-06-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04097175-7e3a-4106-b20e-e134dd84e8e3/documents/7c853d04-30e4-4f1f-aee5-27d38a529b96_84838546-a307-4494-8da3-adb728e0fbf6.html,,oral,discriminating dose,"5,000 mg/kg bw",adverse effect observed, 2-phenoxyethyl methacrylate,10595-06-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04097175-7e3a-4106-b20e-e134dd84e8e3/documents/7c853d04-30e4-4f1f-aee5-27d38a529b96_84838546-a307-4494-8da3-adb728e0fbf6.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 1-phenoxypropan-2-ol,770-35-4,"Two repeated dose dermal toxicity studies (14-days and 28-days) in rabbits are available for phenoxypropanol. Both studies have been conduced under GLP and are equivalent or similar to OECD guideline 410. For the oral route 3 GLP-studies according to OECD guidelines 407, 408 and 416 have been conducted in rats using drinking water administration of the test material. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d29ef548-9def-490e-baac-c282608698f2/documents/5d2e421f-1c3d-4916-b8ea-b4f64bfd3d6d_b1f900de-f35b-4e39-bf7e-7d5c6bda4b44.html,,,,,, 1-phenoxypropan-2-ol,770-35-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d29ef548-9def-490e-baac-c282608698f2/documents/5d2e421f-1c3d-4916-b8ea-b4f64bfd3d6d_b1f900de-f35b-4e39-bf7e-7d5c6bda4b44.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rabbit 1-phenoxypropan-2-ol,770-35-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d29ef548-9def-490e-baac-c282608698f2/documents/5d2e421f-1c3d-4916-b8ea-b4f64bfd3d6d_b1f900de-f35b-4e39-bf7e-7d5c6bda4b44.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,146 mg/kg bw/day,,rat 1-phenoxypropan-2-ol,770-35-4, Non-GLP studies equivalent or similar to OECD guidelines 401 and 402 as well as GLP-studies according to OECD guidelines 402 and 403 are available for phenoxypropanol. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d29ef548-9def-490e-baac-c282608698f2/documents/0667c920-d327-42b3-9e41-85307e3952b1_b1f900de-f35b-4e39-bf7e-7d5c6bda4b44.html,,,,,, 1-phenoxypropan-2-ol,770-35-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d29ef548-9def-490e-baac-c282608698f2/documents/0667c920-d327-42b3-9e41-85307e3952b1_b1f900de-f35b-4e39-bf7e-7d5c6bda4b44.html,,oral,LD50,"2,830 mg/kg bw",adverse effect observed, 1-phenoxypropan-2-ol,770-35-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d29ef548-9def-490e-baac-c282608698f2/documents/0667c920-d327-42b3-9e41-85307e3952b1_b1f900de-f35b-4e39-bf7e-7d5c6bda4b44.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-phenoxypropan-2-ol,770-35-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d29ef548-9def-490e-baac-c282608698f2/documents/0667c920-d327-42b3-9e41-85307e3952b1_b1f900de-f35b-4e39-bf7e-7d5c6bda4b44.html,,inhalation,LC50,"5,400 mg/m3",no adverse effect observed, 3-methyl-1-phenyl-5-pyrazolone,89-25-8, The No Observed Adverse Effect Level (NOAEL) and the Low Observed Adverse Effect Level of the registered item 1-phenyl-3-methyl-5-pyrazolone (A039) was defined respectively as 20 mg/kg/day and 100 mg/kg/day according to the results of the key studies and the REACh regulation. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e47dbaa-56a6-4cd9-9450-6e307381e58c/documents/d34d9ead-eddf-48ca-b662-ebcbcb56bb6b_186059b1-1d87-464f-be42-ec16d3241041.html,,,,,, 3-methyl-1-phenyl-5-pyrazolone,89-25-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e47dbaa-56a6-4cd9-9450-6e307381e58c/documents/d34d9ead-eddf-48ca-b662-ebcbcb56bb6b_186059b1-1d87-464f-be42-ec16d3241041.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat 3-methyl-1-phenyl-5-pyrazolone,89-25-8," Acute oral toxicity : The oral LD50 of the test substance PHENYL METHYL PYRALOZONE is higher than 2000mg/kg in rats. Thus, the test material is not classified as hazardous for acute oral toxicity according to the Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) criteria. Nevertheless, this substance is classified in Category 5 of GHS. (OECD Guideline 401, GLP, Klimisch 1) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e47dbaa-56a6-4cd9-9450-6e307381e58c/documents/aab58980-0373-4e7e-be5f-22a0e1eea784_186059b1-1d87-464f-be42-ec16d3241041.html,,,,,, 3-methyl-1-phenyl-5-pyrazolone,89-25-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e47dbaa-56a6-4cd9-9450-6e307381e58c/documents/aab58980-0373-4e7e-be5f-22a0e1eea784_186059b1-1d87-464f-be42-ec16d3241041.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Phenyl salicylate,118-55-8, Rat oral LD50 of phenyl salicylate is 3000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcb218a6-c066-4e1c-b483-e62cf93677f2/documents/6c89ba0f-4ff5-4790-af58-720bf0165fff_89b636eb-9e7d-409d-9ee9-283b42edfdb3.html,,,,,, Phenyl salicylate,118-55-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcb218a6-c066-4e1c-b483-e62cf93677f2/documents/6c89ba0f-4ff5-4790-af58-720bf0165fff_89b636eb-9e7d-409d-9ee9-283b42edfdb3.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, "1,1,5,5,5-hexamethyl-3-phenyl-3-[(trimethylsilyl)oxy]trisiloxane",2116-84-9," The key acute oral toxicity study, conducted according to OECD TG 423, and in compliance with GLP, reports an LD50 value of >= 2000 mg/kg bw for 1,1,1,5,5,5-hexamethyl-3-phenyl-3-[(trimethylsilyl)oxy]trisiloxane. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/028b6d96-4c15-46c9-a3e2-0bb0a076b0ad/documents/a35a056b-6f0d-48ec-a33f-c035231f8c67_3cd311b7-e099-4663-83a1-726c7daba155.html,,,,,, "1,1,5,5,5-hexamethyl-3-phenyl-3-[(trimethylsilyl)oxy]trisiloxane",2116-84-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/028b6d96-4c15-46c9-a3e2-0bb0a076b0ad/documents/a35a056b-6f0d-48ec-a33f-c035231f8c67_3cd311b7-e099-4663-83a1-726c7daba155.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Phenylacetaldehyde,122-78-1," Oral (OECD 422), rat: NOAEL systemic = 100 mg/kg bw/day in males and females ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b826695c-9c22-4b35-be30-f380239b4d7f/documents/9e50af42-1fed-4e68-8d38-207e06dc36ee_0260b58c-4a67-4da5-ae70-c72327faf2b7.html,,,,,, Phenylacetaldehyde,122-78-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b826695c-9c22-4b35-be30-f380239b4d7f/documents/9e50af42-1fed-4e68-8d38-207e06dc36ee_0260b58c-4a67-4da5-ae70-c72327faf2b7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Phenylacetaldehyde,122-78-1," Oral (similar to OECD 401), rat: LD50 calculated = 1550 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b826695c-9c22-4b35-be30-f380239b4d7f/documents/91b8a477-fec2-4be2-a3e2-afcc5667a3f9_0260b58c-4a67-4da5-ae70-c72327faf2b7.html,,,,,, Phenylacetaldehyde,122-78-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b826695c-9c22-4b35-be30-f380239b4d7f/documents/91b8a477-fec2-4be2-a3e2-afcc5667a3f9_0260b58c-4a67-4da5-ae70-c72327faf2b7.html,,oral,LD50,"1,550 mg/kg bw",adverse effect observed, "1,1-dimethoxy-2-phenylethane",101-48-4," Oral (OECD 422), rat: NOAEL ≥ 600 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da666df5-efa3-4f50-a5e5-606ffbad2c3a/documents/e83c966e-5d2a-4861-b03b-03c997ea656d_cd76b9e8-8550-4e4a-8c30-8f1169e79cd6.html,,,,,, "1,1-dimethoxy-2-phenylethane",101-48-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da666df5-efa3-4f50-a5e5-606ffbad2c3a/documents/e83c966e-5d2a-4861-b03b-03c997ea656d_cd76b9e8-8550-4e4a-8c30-8f1169e79cd6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat "1,1-dimethoxy-2-phenylethane",101-48-4,"Oral (OECD 423), rat: LD50 ≥ 5000 mg/kg bw (limit test)Dermal (OECD 402), rat: LD50 > 5000 mg/kg bw (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da666df5-efa3-4f50-a5e5-606ffbad2c3a/documents/IUC5-c935d0c4-99d7-45cd-a1b0-353289093bc2_cd76b9e8-8550-4e4a-8c30-8f1169e79cd6.html,,,,,, "Benzeneacetaldehyde, cyclic acetal with glycerol",29895-73-6,Acute oral toxicity: OECD TG 401: LD50: 1993 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ef348ed-b68a-48bf-91de-0de693aabafa/documents/IUC5-c54a6699-887e-4dc3-948b-3a6678ec235f_d6c0a679-9465-4523-b537-4192b79a54a4.html,,,,,, "Benzeneacetaldehyde, cyclic acetal with glycerol",29895-73-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ef348ed-b68a-48bf-91de-0de693aabafa/documents/IUC5-c54a6699-887e-4dc3-948b-3a6678ec235f_d6c0a679-9465-4523-b537-4192b79a54a4.html,,oral,LD50,"1,993 mg/kg bw",adverse effect observed, "2-benzyl-4,4,6-trimethyl-1,3-dioxane",67633-94-7, Acute oral toxicity (similar to OECD TG 401): LD50 >5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7284cd5f-fe9f-49b4-993e-d27d8e0d8c22/documents/2070fb4e-fa18-4d3a-8685-1c1d16a0cc21_8c0e0de7-6eb1-4ef7-b2d8-ef30cdcc94b2.html,,,,,, Phenylacetic acid,103-82-2," Repeated dose toxicity: Oral Based on the data available, the No Observed Adverse Effect Level (NOAEL) for the test chemical was considered to be 1000mg/Kg bw using male and female rats. Hence the test chemical is not likely to be toxic upon repeated exposure by oral route as per the criteria mentioned in CLP regulation. Repeated dose toxicity: inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the test chemical  which is reported as 0.0038 mm Hg at 25 deg C.Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely. Therefore this study is considered for waiver. Repeated dose toxicity: dermal The acute toxicity value for test chemical (as provided in section 7.2.1) was considered to be >2000 mg/kg body weight. Thus, it is expected that phenylacetic acid shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. hence this end point was considered for waiver ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31383d31-adb6-4780-9e08-1454d6773432/documents/50a0e364-9125-4b8e-9163-0e301a13a8c9_a09cf8be-fc8f-4dc7-86d5-a1066bd248a6.html,,,,,, Phenylacetic acid,103-82-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31383d31-adb6-4780-9e08-1454d6773432/documents/50a0e364-9125-4b8e-9163-0e301a13a8c9_a09cf8be-fc8f-4dc7-86d5-a1066bd248a6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Phenylacetic acid,103-82-2," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats, mice and guinea pigs for the given test chemical. The LD50 value is >5000 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity dose (LC50) was considered based on different studies conducted on rats for the given test chemical. The studies concluded that the LC50 value is >5 mg/L (>5000 mg/m3), for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute inhalation toxicity. Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is >5000 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31383d31-adb6-4780-9e08-1454d6773432/documents/d641d433-752b-4abd-9bfc-1c7babe5a2a2_a09cf8be-fc8f-4dc7-86d5-a1066bd248a6.html,,,,,, Phenylacetic acid,103-82-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31383d31-adb6-4780-9e08-1454d6773432/documents/d641d433-752b-4abd-9bfc-1c7babe5a2a2_a09cf8be-fc8f-4dc7-86d5-a1066bd248a6.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Phenylacetic acid,103-82-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31383d31-adb6-4780-9e08-1454d6773432/documents/d641d433-752b-4abd-9bfc-1c7babe5a2a2_a09cf8be-fc8f-4dc7-86d5-a1066bd248a6.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Phenylacetic acid,103-82-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31383d31-adb6-4780-9e08-1454d6773432/documents/d641d433-752b-4abd-9bfc-1c7babe5a2a2_a09cf8be-fc8f-4dc7-86d5-a1066bd248a6.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, 3-phenyl-L-alanine,63-91-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38c4f819-6ccb-4227-8be0-2fde5c15a86e/documents/3e86ab26-6551-4dff-af73-21637149c915_c5e15c4f-573c-4486-9b48-207928878d78.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,500 mg/kg bw/day",,rat 3-phenyl-L-alanine,63-91-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38c4f819-6ccb-4227-8be0-2fde5c15a86e/documents/IUC5-826d706e-016a-4414-b49c-61e12fca0a35_c5e15c4f-573c-4486-9b48-207928878d78.html,,oral,LD50,"16,000 mg/kg bw",no adverse effect observed, 2-phenyl-1H-benzimidazole-5-sulphonic acid,27503-81-7, Based on a 90-day oral toxicity study according to OECD 408 it is concluded that test article showed no treatment-related adverse effects in all test doses up to 1000 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8b702d6-db14-4e94-a5cd-34eb7e85a6b0/documents/IUC5-6de26e7e-956c-4eb5-b0f9-d3dcac0df6ef_887191f7-9ce3-43d6-9e3b-2a773358a541.html,,,,,, 2-phenyl-1H-benzimidazole-5-sulphonic acid,27503-81-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8b702d6-db14-4e94-a5cd-34eb7e85a6b0/documents/IUC5-6de26e7e-956c-4eb5-b0f9-d3dcac0df6ef_887191f7-9ce3-43d6-9e3b-2a773358a541.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-phenyl-1H-benzimidazole-5-sulphonic acid,27503-81-7,"  The substance is neiter classifiable for acute oral toxicity nor for acute dermal toxicity. An inhalative study is not available and not required considering the low vapour pressure of the substance and its use in cosmetic skin formulations.   Besides the key study performed with sodium salt of test substance also two supportive studies are available, one performed with the sodium salt of test substance (LD50 >16000 mg/kg bw) and one with the substance itself (LD50 >5000 mg/kg bw). Thus, there is a solid basis for considering this substance practically non toxic. Two studies are available providing very consistent results, although neutralized with different alkali. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8b702d6-db14-4e94-a5cd-34eb7e85a6b0/documents/IUC5-05818630-1e57-44f9-9f8a-eee63eb8c259_887191f7-9ce3-43d6-9e3b-2a773358a541.html,,,,,, 2-phenyl-1H-benzimidazole-5-sulphonic acid,27503-81-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8b702d6-db14-4e94-a5cd-34eb7e85a6b0/documents/IUC5-05818630-1e57-44f9-9f8a-eee63eb8c259_887191f7-9ce3-43d6-9e3b-2a773358a541.html,,oral,LD50,"6,600 mg/kg bw",no adverse effect observed, 2-phenyl-1H-benzimidazole-5-sulphonic acid,27503-81-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8b702d6-db14-4e94-a5cd-34eb7e85a6b0/documents/IUC5-05818630-1e57-44f9-9f8a-eee63eb8c259_887191f7-9ce3-43d6-9e3b-2a773358a541.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, "3,3'-(1,4-Phenylene)bis(5,6-diphenyl-1,2,4-triazine)",55514-22-2,Both acute oral and dermal tests (reliability 1) performed on WP30 gave LD50 > 2000 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a311ea10-7bc3-4c4d-9b8d-6769bbab1d11/documents/IUC5-36eeb397-4696-4d53-9bba-44c22f2cd976_2e9c94cd-012f-4aad-91a6-012ce7004e89.html,,,,,, "4-(1-Phenylethyl)-benzene-1,3-diol",85-27-8,"NOEL (28d, rat, oral) = 60 mg/kg bw/day (subacute)(OECD 407; GLP compliant)NOAEL (13 weeks, rat, oral) = 20 mg/kg/day (subchronic)(OECD 408; GLP compliant) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d6a6d875-8e3b-42ce-9ecf-b8bcbf375e02/documents/IUC5-0cdc19fc-4bc9-49fb-aca7-76a96e3625fe_13a28174-ab2a-4ff1-9de9-0ffc0c70e20c.html,,,,,, "4-(1-Phenylethyl)-benzene-1,3-diol",85-27-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d6a6d875-8e3b-42ce-9ecf-b8bcbf375e02/documents/IUC5-0cdc19fc-4bc9-49fb-aca7-76a96e3625fe_13a28174-ab2a-4ff1-9de9-0ffc0c70e20c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "4-(1-Phenylethyl)-benzene-1,3-diol",85-27-8,"Acute oral toxicity: 300 mg/kg bw < LD50 ≤ 2000 mg/kg bw (LD50 cut-off mg/kg bw: 500 mg/kg bw) (OECD 423, GLP compliant)Acute inhalation toxicity: data waivingAcute dermal toxicity: LD50 > 2000 mg/kg bw (OECD 402, GLP compliant) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6a6d875-8e3b-42ce-9ecf-b8bcbf375e02/documents/IUC5-f51bb3c3-2827-4f90-8693-ec047ebcf827_13a28174-ab2a-4ff1-9de9-0ffc0c70e20c.html,,,,,, "4-(1-Phenylethyl)-benzene-1,3-diol",85-27-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6a6d875-8e3b-42ce-9ecf-b8bcbf375e02/documents/IUC5-f51bb3c3-2827-4f90-8693-ec047ebcf827_13a28174-ab2a-4ff1-9de9-0ffc0c70e20c.html,,oral,LD50,500 mg/kg bw,, 3-methyl-5-phenylpentanol,55066-48-3,"The key study is a GLP and OECD 407 subacute (28 days) oral toxicity study, performed on rats, with a similar compound (the aldehyde of Mefrosol). Under the conditions of the study, treatment-related changes were observed at 500 mg/kg bw/day (males and females) and 150 mg/kg bw/day (females only). The NOEL was therefore considered to be 150 mg/kg bw/day for males and 15 mg/kg bw/day for females. Regarding adversity, the NOAEL was determined to be 150 mg/kg bw/day for either sex, based on increased liver and kidney weights, as well as histopathogical changes in the liver and thryoid glands. A 14-day range finder study was performed before the main study for the dose level selection and was provided as supporting information. The two available studies have a Klimisch score of 2, based on read-across. The quality of the database is therefore high. The read-across approach allows to extrapolate these data to Mefrosol. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee41448e-6586-4550-b3b9-bbda99cb0832/documents/ef7b8c52-66b2-40f1-a165-1c9f7f996f85_e763e496-4850-462f-a58e-e9fb6d54e10a.html,,,,,, 3-methyl-5-phenylpentanol,55066-48-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee41448e-6586-4550-b3b9-bbda99cb0832/documents/ef7b8c52-66b2-40f1-a165-1c9f7f996f85_e763e496-4850-462f-a58e-e9fb6d54e10a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,ca.150 mg/kg bw/day,,rat 3-methyl-5-phenylpentanol,55066-48-3,"ORALKey study: Freeman (1980a) Acute toxicity: oral (OECD 401): LD50 2500 mg/kg bw (1800-3500 mg/kg bw) in males, 1850 mg/kg bw (1190-2870 mg/kg bw) in females (selected as the key value) and 2300 mg/kg bw (1760-3010 mg/kg bw) for males/females (combined)INHALATIONA data waiver was submitted to address acute toxicity via the inhalatory route. Based on the known properties of the substance, exposure via inhalation is not considered to be a likely route of exposure.DERMALKey study: Freeman (1980b) Acute toxicity: dermal (similar to OECD 402): LD50 > 5000 mg/kg bw (male rats), 3100 mg/kg bw (female rats) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee41448e-6586-4550-b3b9-bbda99cb0832/documents/IUC5-5345ac88-8aaa-49f9-98ae-8ac04e56b815_e763e496-4850-462f-a58e-e9fb6d54e10a.html,,,,,, 3-methyl-5-phenylpentanol,55066-48-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee41448e-6586-4550-b3b9-bbda99cb0832/documents/IUC5-5345ac88-8aaa-49f9-98ae-8ac04e56b815_e763e496-4850-462f-a58e-e9fb6d54e10a.html,,oral,LD50,"1,850 mg/kg bw",no adverse effect observed, 3-methyl-5-phenylpentanol,55066-48-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee41448e-6586-4550-b3b9-bbda99cb0832/documents/IUC5-5345ac88-8aaa-49f9-98ae-8ac04e56b815_e763e496-4850-462f-a58e-e9fb6d54e10a.html,,dermal,LD50,"3,100 mg/kg bw",no adverse effect observed, Phenyl 4-hydroxybenzoate,17696-62-7," In an acute oral toxicity study (fixed dose procedure, OECD 420), fasted, 8-9 weeks old female Wistar rats (1 at step 1 and 4 at step 2) were given a single oral dose of the test item (99.1% purity) in DMSO at the limit dose of 2000 mg/kg by gavage and were observed for 14 days. Based on the results from this study, the oral LD50 in rats can considered to be greater than 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef7d35cf-1c68-4dc2-a221-51dd55a69b33/documents/16c80501-3ab4-4fee-9e83-cf8a0fa5d358_17abcbe7-98c0-47d6-b2a9-c8d4db11f922.html,,,,,, 3-phenylpropan-1-ol,122-97-4, In a subacute oral toxicity study the NOAEL was found to be 1000 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da8b032a-d026-4ec3-9b35-a01adf686ad7/documents/82fef82a-77af-4f60-bf7f-a2e79b08c652_f494a2b7-3528-4213-b7b4-c006d7781d20.html,,,,,, 3-phenylpropan-1-ol,122-97-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da8b032a-d026-4ec3-9b35-a01adf686ad7/documents/82fef82a-77af-4f60-bf7f-a2e79b08c652_f494a2b7-3528-4213-b7b4-c006d7781d20.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 3-phenylpropan-1-ol,122-97-4, Based on weight of evidence approaches the LD50 for oral and dermal application of the test substance were found to be > 2000 mg/kg bw and < 5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da8b032a-d026-4ec3-9b35-a01adf686ad7/documents/e08b4495-a7e5-4dc7-a532-aa93b6bbd132_f494a2b7-3528-4213-b7b4-c006d7781d20.html,,,,,, 3-phenylpropan-1-ol,122-97-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da8b032a-d026-4ec3-9b35-a01adf686ad7/documents/e08b4495-a7e5-4dc7-a532-aa93b6bbd132_f494a2b7-3528-4213-b7b4-c006d7781d20.html,,oral,LD50,"2,250 mg/kg bw",adverse effect observed, 3-phenylpropan-1-ol,122-97-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da8b032a-d026-4ec3-9b35-a01adf686ad7/documents/e08b4495-a7e5-4dc7-a532-aa93b6bbd132_f494a2b7-3528-4213-b7b4-c006d7781d20.html,,dermal,LD50,"5,000 mg/kg bw",adverse effect observed, "2'-(β-D-glucopyranosyloxy)-4',6'-dihydroxy-3-(4-hydroxyphenyl)propiophenone",60-81-1," Oral route: Weight of evidence: Based on the available information for the read-across approach and the supporting information, the oral LD50 of the test item in rats is ≥ 3562 mg/kg bw. - Read-across from analogue substance. Source: Method similar to OECD 420. Based on read-across approach, the oral LD50 in rats for the target substance was determined to be ≥ 3562 mg/kg bw. - Read-across from analogue substance. Source: Method similar to OECD 420. Based on read-across approach, the oral LD50 in rats for the target substance was determined to be ≥ 3562 mg/kg bw. - Supporting study: Method similar to OECD 420. The oral LD50 in rats of an apple extract containing phloridzin was found to be > 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28cc0c8d-2404-40ef-b479-8b78af63841c/documents/d4665cf9-3233-4f04-aa49-ed61a24e625a_5523c08e-8474-4fa9-aa60-d8d0e3bf46c8.html,,,,,, "2'-(β-D-glucopyranosyloxy)-4',6'-dihydroxy-3-(4-hydroxyphenyl)propiophenone",60-81-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28cc0c8d-2404-40ef-b479-8b78af63841c/documents/d4665cf9-3233-4f04-aa49-ed61a24e625a_5523c08e-8474-4fa9-aa60-d8d0e3bf46c8.html,,oral,LD50,"3,562 mg/kg bw",no adverse effect observed, Phloroglucinol,108-73-6," At the tested dose of 300 mg/kg bw/day (rat, oral, gavage) no toxic effects were observed. See also the attached EMEA summary report for supportive information regarding a study in which dogs were treated for 6 months (oral). No toxic effects were observed at even the maximum dose of 125 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77e32d18-079e-438b-8adc-3d5628fcb284/documents/50bed30c-9a42-4c2e-aed1-b51ae539688e_0ba0d88a-3b7c-49e8-a0d2-cdcd0a3080ac.html,,,,,, Phloroglucinol,108-73-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77e32d18-079e-438b-8adc-3d5628fcb284/documents/50bed30c-9a42-4c2e-aed1-b51ae539688e_0ba0d88a-3b7c-49e8-a0d2-cdcd0a3080ac.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Phloroglucinol,108-73-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77e32d18-079e-438b-8adc-3d5628fcb284/documents/94d11ce6-bec0-4e50-9c70-1c82aed0b431_0ba0d88a-3b7c-49e8-a0d2-cdcd0a3080ac.html,,oral,LD50,"4,000 mg/kg bw",adverse effect observed, "2-phosphonobutane-1,2,4-tricarboxylic acid",37971-36-1,"As there is no data available for 2-phosphonobutane-1,2,4-tricarboxylic acid a read-across approach with tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate is proposed.   In aqueous media, 2-phosphono-butane-1,2,4-tricarboxylic acid and tetrasodium hydrogen 2-phosphonatobutane-tricarboxylate dissociate into the corresponding anion (2-phosphonatobutane-tricarboxylate ion) and hydrogen ion (proton) and the sodium ion, respectively. The toxicological properties of 2-phosphonobutane-1,2,4-tricarboxylic acid and its tetrasodium salt are thought to be an effect of the phosphonato-carboxylate ion rather than of the sodium ion or the hydrogen ion (proton), which are normal constituents in body fluids and have no relevant toxic properties in low concentrations.   Therefore a read-across between 2-phosphono-butane-1,2,4-tricarboxylic acid and tetrasodium hydrogen 2-phosphonatobutane-tricarboxylate is justified.   A 3-months feeding study in rats with technical tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate (50, 200, 1000, 5000 ppm = male rats: 0, 4.17, 14.91, 84.11, 424.41 mg/kg bw/day, female rats: 0, 6.05, 12.51, 125.48, 632.65 mg/kg bw/day ) results in a NOAEL equal or higher than 5000 ppm (equivalent to about 424 mg/kg bw/day for male rats and 632 mg/kg bw/day for female rats). Conclusion for subchronic exposure: Low toxicity, no damage in oral doses up to 424 mg/kg/body weight/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The materials/methods and results are described in detail und are sufficient for evaluation ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/766ff9b4-e1cf-4265-98c3-c9cad102db51/documents/67fc487a-808f-4c68-a28f-7d9e95ab8722_a9970654-2016-4ac2-8172-ed58e9e72730.html,,,,,, "2-phosphonobutane-1,2,4-tricarboxylic acid",37971-36-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/766ff9b4-e1cf-4265-98c3-c9cad102db51/documents/67fc487a-808f-4c68-a28f-7d9e95ab8722_a9970654-2016-4ac2-8172-ed58e9e72730.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,424 mg/kg bw/day,,rat "2-phosphonobutane-1,2,4-tricarboxylic acid",37971-36-1," Bayhibit AM (2-phosphonobutane-1,2,4-tricarboxylic acid) was tested for acute oral (gavage) toxicity in 10 rats by single applications that were well tolerated by all animals. The LD50 found was > 5 mL/kg bw (> 3250 mg/kg bw). As there are no studies available for acute inhalation and acute dermal toxicity for 2-phosphonobutane-1,2,4-tricarboxylic acid a read-across approach with tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate (Bayhibit AM-Tetra-sodium salt) is proposed. In aqueous media, 2-phosphono-butane-1,2,4-tricarboxylic acid and tetrasodium hydrogen 2-phosphonatobutane-tricarboxylate dissociate into the corresponding anion (2-phosphonatobutane-tricarboxylate ion) and hydrogen ion (proton) and the sodium ion, respectively. The toxicological properties of 2-phosphonobutane-1,2,4-tricarboxylic acid and its tetrasodium salt are thought to be an effect of the phosphonato-carboxylate ion rather than of the sodium ion or the hydrogen ion (proton), which are normal constituents in body fluids and have no relevant toxic properties in low concentrations. Therefore a read-across between 2-phosphono-butane-1,2,4-tricarboxylic acid and tetrasodium hydrogen 2-phosphonatobutane-tricarboxylate is justified. Acute inhalation toxicity was determined for the test substance tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate. The LC50 (inhalation, rat) of tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate is >1979 mg/m³. A dose level of 1300 mg/kg of the test substance tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate (32.6 % aqueous solution) was examined for acute dermal toxicity resulting in a LD50 (dermal, rat) of > 1300 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/766ff9b4-e1cf-4265-98c3-c9cad102db51/documents/IUC5-d6ef2379-ae36-49a6-bba3-8195cbf04369_a9970654-2016-4ac2-8172-ed58e9e72730.html,,,,,, "2-phosphonobutane-1,2,4-tricarboxylic acid",37971-36-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/766ff9b4-e1cf-4265-98c3-c9cad102db51/documents/IUC5-d6ef2379-ae36-49a6-bba3-8195cbf04369_a9970654-2016-4ac2-8172-ed58e9e72730.html,,oral,LD50,"3,250 mg/kg bw",no adverse effect observed, "2-phosphonobutane-1,2,4-tricarboxylic acid",37971-36-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/766ff9b4-e1cf-4265-98c3-c9cad102db51/documents/IUC5-d6ef2379-ae36-49a6-bba3-8195cbf04369_a9970654-2016-4ac2-8172-ed58e9e72730.html,,dermal,LD50,"1,300 mg/kg bw",no adverse effect observed, "2-phosphonobutane-1,2,4-tricarboxylic acid",37971-36-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/766ff9b4-e1cf-4265-98c3-c9cad102db51/documents/IUC5-d6ef2379-ae36-49a6-bba3-8195cbf04369_a9970654-2016-4ac2-8172-ed58e9e72730.html,,inhalation,LC50,"1,979 mg/m3",no adverse effect observed, Orthophosphoric acid,7664-38-2,"Repeated dose toxicity: oralTwo key studies exist. Both studies are assigned a Klimisch 2 rating and have been selected as key studies for derivation of DNELs. Repeated dose toxicity: dermalNo reliable data were available for the dermal route of exposure. Therefore, testing via this exposure route is waived according to column 2 adaptation.Repeated dose toxicity: inhalationNo reliable data were available for the inhalation route of exposure. Therefore, testing for this exposure route is waived based on column 2 adaptation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49f3316e-ce79-4ef0-9daa-e5e5579f7a81/documents/IUC5-1708a6fb-2164-4e3d-b59f-353100d57e89_d959194a-f51d-4ef8-8cd2-21dd517134db.html,,,,,, Orthophosphoric acid,7664-38-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49f3316e-ce79-4ef0-9daa-e5e5579f7a81/documents/IUC5-1708a6fb-2164-4e3d-b59f-353100d57e89_d959194a-f51d-4ef8-8cd2-21dd517134db.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,155 mg/kg bw/day,,rat Orthophosphoric acid,7664-38-2,"Acute toxicity: oralA number of Klimisch 4 studies are available, these support the weight of evidence for a classification as category 4.Acute toxicity: inhalationNo reliable data on phosphoric acid are available for the inhalation route of exposure.Acute toxicity: dermalNo reliable data on phosphoric acid are available for the dermal route of exposure. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49f3316e-ce79-4ef0-9daa-e5e5579f7a81/documents/IUC5-91efe0d4-9104-4437-8c6e-ec23cf59414e_d959194a-f51d-4ef8-8cd2-21dd517134db.html,,,,,, Phosphorus,7723-14-0,"NOAEL, Rat, Oral (Gavage), 5 Weeks = 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f0500db-921e-4471-98f9-fdfac25a6bd3/documents/IUC5-7b0ea081-ffab-41fa-a8e4-eaa78cccb120_52d8bf6f-3e27-4e1e-bd0a-930e3396ea80.html,,,,,, Phosphorus,7723-14-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f0500db-921e-4471-98f9-fdfac25a6bd3/documents/IUC5-7b0ea081-ffab-41fa-a8e4-eaa78cccb120_52d8bf6f-3e27-4e1e-bd0a-930e3396ea80.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Phosphorus,7723-14-0,"LD50, Oral, Rats > 2000 mg/kg bodyweight.LD50 (4 hours), Inhaled, Rats > 5.75 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f0500db-921e-4471-98f9-fdfac25a6bd3/documents/IUC5-b3c8f3e2-0cc1-48b1-b595-31cf8b7113d8_52d8bf6f-3e27-4e1e-bd0a-930e3396ea80.html,,,,,, Phthalic anhydride,85-44-9," Chronic oral feeding studies over 2 years in rats and mice including dose finding studies over 7 weeks were conducted by the NCI (National Cancer Institute) for the evaluation of a possible carcinogenicity of phthalic anhydride. In the 7 weeks dose finding study groups of 5 rats and 5 mice of each sex were administered feed containing 0, 6.200, 12.500, 25.000 or 50.000 ppm phthalic anhydride. The lowest dose at which histopathologic findings were observed in male and female rats was 25.000 ppm (ca. 2500 mg/kg bw). At this dose, trace amounts of centrilobular cytoplasmic vacuolation were seen in the livers of 4 males; however, tissues were essentially normal in both males and females at 50.000 ppm (5000 mg/kg bw). Tissues were essentially normal also in male and female mice at 50.000 ppm. In the chronic 2 years study 50 male and female rats each (20 male and 20 female rats as control) were fed doses of the test substance of 0, 7.500, or 15.000 ppm (ca. 0, 500, 1000 mg/kg bw/d for 102-106 consecutive weeks, followed by sacrifice, necropsy and histopathological examination of major organs and tissues. In addition 50 male and female mice each (20 male and 20 female mice as control) were fed daily doses of the test substance of 0, 25.000, or 50.000 ppm (ca. 0, 3570, 7140 mg/kg bw/d for 32 weeks. From week 32 to weeks 104 the daily doses were reduced to 0, 12.500 and 25.000 ppm for male mice and to 0, 6.250 and 12.500 ppm to female mice. After the termination of the study on week 104, the animals were sacrificed and necropsy and histopathological examination were performed. No hematology and no clinical chemistry endpoints were examined. Severe chronic inflammatory, degenerative, or proliferative lesions frequently seen in aged rats and mice occurred with approx. equal frequency and severity in the dosed and control groups of animals. No tumors occurred in the rats and mice of either sex at incidences that could be clearly related to the administration of the test substance. No reliable studies are available using the dermal and respiratory routes of exposure. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14abf7c3-fa64-473e-b37c-0749b78be032/documents/IUC5-443d997c-7a27-41c0-9951-626c3811b88e_322026cb-21a3-4078-b45b-6127fa189dce.html,,,,,, Phthalic anhydride,85-44-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14abf7c3-fa64-473e-b37c-0749b78be032/documents/IUC5-443d997c-7a27-41c0-9951-626c3811b88e_322026cb-21a3-4078-b45b-6127fa189dce.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Phthalic anhydride,85-44-9," In a study conducted in male rats, an oral LD50 = 1530 mg/kg bw was found. This value is supported by several other studies in which a LD50 value was found in a similar range, however these studies are not reliable due to limited documentation. In a valid study for acute inhalation toxicity a LC50 > 2.14 mg/L (highest technically feasible concentration) was found. All animals (except one) survived the post-exposure period. Clinical signs and necropsy revealed no indication that this concentration might be fatal. Therefore it can be concluded, that the LC50 value is much higher than the technically feasible concentration of the experiment. A classification for acute inhalation toxicity is no justified. No valid studies are available with dermal exposure. From 2 not reliable studies, a dermal LD50 > 3160 mg/kg bw and > 10000 mg/kg bw was indicated. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14abf7c3-fa64-473e-b37c-0749b78be032/documents/IUC5-6593252a-d24f-4e01-a991-d40dfd628fcf_322026cb-21a3-4078-b45b-6127fa189dce.html,,,,,, Phthalic anhydride,85-44-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14abf7c3-fa64-473e-b37c-0749b78be032/documents/IUC5-6593252a-d24f-4e01-a991-d40dfd628fcf_322026cb-21a3-4078-b45b-6127fa189dce.html,,oral,LD50,"1,530 mg/kg bw",adverse effect observed, Phthalic anhydride,85-44-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14abf7c3-fa64-473e-b37c-0749b78be032/documents/IUC5-6593252a-d24f-4e01-a991-d40dfd628fcf_322026cb-21a3-4078-b45b-6127fa189dce.html,,inhalation,discriminating conc.,"2,140 mg/m3",adverse effect observed, "3,7,11,15-tetramethylhexadecane-1,2,3-triol",74563-64-7," Repeat dose toxicity: Oral Route (OECD 422): The test item, formulated in propylene glycol, was administered daily by oral gavage to SPFbred Wistar Han rats in a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test. One control group and three treated groups were tested (50, 150, 500 mg/kg bw/day), each consisting of 10 males and 10 females. Males were treated for 30 days, i.e. 2 weeks prior to mating, during mating, and up to termination. Females were treated for 50-55 days, i.e. during 2 weeks prior to mating, during mating, during post-coitum, and during 13-15 days of lactation. Females which failed to deliver healthy offspring were treated for 41-54 days. The following observations and examinations were evaluated: mortality / viability, clinical signs (daily), functional observations and locomotor activity (end of treatment), body weight and food consumption (at least at weekly intervals), estrous cycle determination (14 days prior to treatment, 14 days of treatment and during mating until evidence of mating, and the day of necropsy), clinical pathology (end of treatment), measurement of thyroid hormone T4 (F0-males at the end of treatment, PND 13-15 pups), macroscopy at termination, organ weights and histopathology on a selection of tissues. In addition, the following reproduction/developmental parameters were determined: mating, fertility, precoital time, number of implantation sites, gestation index and duration, parturition, maternal care, sex ratio and early postnatal pup development (mortality, clinical signs, body weights, sex, anogenital distance, areola/nipple retention and macroscopy). Blood was sampled for exposure control evaluation (from first 5 F0-males and all F0-females/sex/group at day 14 of treatment and from PND 13-15 pups from litters of the selected 5 F0-females). Accuracy and homogeneity of formulations were demonstrated by analyses. Parental results: After treatment at 500 mg/kg bw/day, a minimal increase in fore limb grip strength was observed in both sexes and a slightly different habituation profile in males only, as expressed by a higher number of movements and ambulations during the first part of motor activity testing. Due to the low magnitude of the changes in grip strength and motor activity, the results were still within the normal limits for these parameters in rats of this age and strain. Therefore, these findings at the dose level of 500 mg/kg bw/day were considered to be non-adverse. Treatment-related changes at 500 mg/kg bw/day were observed as statistically significant lower body weights and food consumption, changes in several clinical biochemistry parameters, including increases in ALAT and ASAT, and glucose and a decrease in total protein. The changes in glucose and total protein were considered to be non-adverse, based on the low magnitude of change. Minimal increases in liver weights were observed in these high dose animals, still remaining within normal limits. In addition, a low severity of hepatocellular hypertrophy was recorded in the females at 500 mg/kg bw/day, which was considered to be a non-adverse finding in the absence of any degenerative findings in the liver of these animals. Whereas the increases in the enzyme levels ALAT and ASAT and liver weights were slightly more pronounced in males than in females, the hepatocellular hypertrophy was only seen in females. Although the increased enzyme levels might be indicative of liver damage, this was not confirmed by histopathology in the males. Therefore, also the changes in enzyme levels and liver weight were considered to be non-adverse. Histopathological examination revealed squamous cell hyperplasia and edema in the stomach of males at 500 mg/kg bw/day, which were considered to represent non-adverse mild local reaction to the test item. No treatment-related changes were noted after treatment at 500 mg/kg bw/day in the other parental parameters investigated in this study (i.e. clinical appearance, haematology investigations, sperm staging (in males) and estrous cycle (in females)). Any changes in the various study parameters after treatment at 50 and 150 mg/kg bw/day were considered no signs of treatment related parental toxicity. In conclusion, treatment with Phytantriol by oral gavage in male and female Wistar Han rats at dose levels of 50, 150 and 500 mg/kg bw/day revealed parental toxicity at 500 mg/kg bw/day, expressed as reduced body weight gain and food consumption. Furthermore, non-adverse increases in enzyme levels of ALAT and ASAT and liver weights (both sexes), hepatocellular hypertrophy (females only) and mild local reaction in the stomach to the test item in males (squamous cell hyperplasia and edema) were observed. Based on these results, a NOAEL parental toxicity of 150 mg/kg bw/day is derived. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eee1417e-2b6c-4f64-be90-cf62fe684e17/documents/3dd7c50b-4955-41b9-bf9a-2fa509e090e6_8a06dbc8-1139-4a6d-9159-81f6445b2948.html,,,,,, "3,7,11,15-tetramethylhexadecane-1,2,3-triol",74563-64-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eee1417e-2b6c-4f64-be90-cf62fe684e17/documents/3dd7c50b-4955-41b9-bf9a-2fa509e090e6_8a06dbc8-1139-4a6d-9159-81f6445b2948.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "3,7,11,15-tetramethylhexadecane-1,2,3-triol",74563-64-7," The acute oral toxicity of the test substance was assessed according to OECD Test Guideline 423 (acute toxic class method), EU Method B.1 tris and EPA OPPTS 870.1100 using a single oral dose of the test material preparation in olive oil at a dose level of 2000 mg/kg body weight. No mortality occurred.  No abnormalities were noted at necropsy of animals sacrificed at the end of the study. Under the conditions of this study the median lethal dose of the test substance after oral application was found to be greater than 2000 mg/kg body weight for the male and female animals.  The test substance is therefore not classified for acute oral toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eee1417e-2b6c-4f64-be90-cf62fe684e17/documents/a6d71c5e-a752-418e-bec1-adba21d9fd05_8a06dbc8-1139-4a6d-9159-81f6445b2948.html,,,,,, "3,7,11,15-tetramethylhexadecane-1,2,3-triol",74563-64-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eee1417e-2b6c-4f64-be90-cf62fe684e17/documents/a6d71c5e-a752-418e-bec1-adba21d9fd05_8a06dbc8-1139-4a6d-9159-81f6445b2948.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Fytic acid,83-86-3," Acute Toxicity Oral (published data), rat (Fischer 344/DuCrj) m / f: LD50: 405 mg/kg bw (male); 480 mg/kg bw (female) Acute Toxicity Oral (published data), mice (ICL-ICR) m / f: LD50: 900 mg/kg bw (male); 1150 mg/kg bw (female) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfaa35c0-d869-4a2d-af8d-3becffff7a80/documents/ed114ee8-5ec3-4aa8-a7af-e617926b6e63_17dd5cc9-688d-4c56-ab31-a6c6002d5ea2.html,,,,,, Fytic acid,83-86-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfaa35c0-d869-4a2d-af8d-3becffff7a80/documents/ed114ee8-5ec3-4aa8-a7af-e617926b6e63_17dd5cc9-688d-4c56-ab31-a6c6002d5ea2.html,,oral,LD50,405 mg/kg bw,adverse effect observed, "(2S,3S,4R)-2-aminooctadecane-1,3,4-triol",554-62-1, Acute oral toxicity: LD50 > 5000 mg/kg (rat) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40de797d-1180-4b17-a93b-086f92e270bc/documents/3f10713b-2163-4735-90e7-2d117174710d_c26a3371-1eb4-4bbc-a2e2-09a5f71aae69.html,,,,,, Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,5281-04-9," NOAEL (male) 100 mg/kg bw/day, NOEL (female) <100 mg/kg bw/day for systemic toxicity Pigment Red 57:1(Ca) (OECD 422, GLP, MHLW 1993). No edverse effects on reproductive toxicity was observed. Based on results obtained from other category members, a NOAEL of 25 mg/kg bw/day was established. No histopathology findings on kidneys were reported after a two-year skin painting study with mice with Pigment Red 57:1(Ca) (Carson 1984). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b309107-5273-42f6-b4d8-b470a36cbbc8/documents/IUC5-ff54a16a-c789-45a2-aafe-5bd668e7ab33_f2f9c7da-661d-4244-b042-848b5e256b99.html,,,,,, Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,5281-04-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b309107-5273-42f6-b4d8-b470a36cbbc8/documents/IUC5-ff54a16a-c789-45a2-aafe-5bd668e7ab33_f2f9c7da-661d-4244-b042-848b5e256b99.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,5281-04-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b309107-5273-42f6-b4d8-b470a36cbbc8/documents/IUC5-ff54a16a-c789-45a2-aafe-5bd668e7ab33_f2f9c7da-661d-4244-b042-848b5e256b99.html,Chronic toxicity – systemic effects,dermal,NOAEL,50 mg/kg bw/day,,mouse Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,5281-04-9," Studies investigating oral, inhalation, and dermal acute toxicity are available. Oral LD50 >5000 mg/kg bw Inhalation LD50 >1518 mg/m3 Dermal LD50 >2500 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b309107-5273-42f6-b4d8-b470a36cbbc8/documents/IUC5-5ba8945e-770e-4429-b990-033b6e314f03_f2f9c7da-661d-4244-b042-848b5e256b99.html,,,,,, Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,5281-04-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b309107-5273-42f6-b4d8-b470a36cbbc8/documents/IUC5-5ba8945e-770e-4429-b990-033b6e314f03_f2f9c7da-661d-4244-b042-848b5e256b99.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,5281-04-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b309107-5273-42f6-b4d8-b470a36cbbc8/documents/IUC5-5ba8945e-770e-4429-b990-033b6e314f03_f2f9c7da-661d-4244-b042-848b5e256b99.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,5281-04-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b309107-5273-42f6-b4d8-b470a36cbbc8/documents/IUC5-5ba8945e-770e-4429-b990-033b6e314f03_f2f9c7da-661d-4244-b042-848b5e256b99.html,,inhalation,LC50,"1,518 mg/m3",no adverse effect observed, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]",6358-85-6,"A combined repeated dose toxicity study with reproduction/developmental toxicity screening test with the test item administered by oral gavage in Wistar rats (10/sex/dose) was performed according to OECD TG 422. From the results presented in this report a definitive No Observed Adverse Effect Level (NOAEL) for parental and reproduction/developmental toxicity for the test item of 1000 mg/kg/day was established. No toxic effects were observed in an oral chronic repeated dose toxicity study in rats (highest dose tested: 555 mg/kg bw/day). The only effect observable after subacute inhalation exposure was minimal deposition of test material in the lung, which was not accompanied by an inflammatory or any other adverse response at low concentrations. The repeated dose toxicity potential of registration substance is assessed based on results of structure analogue pigment yellow 13 using analogue approach. The test item did not elicit relevant toxicological effects after subacute inhalation exposure except for some local effects in the lungs of the treated animals probably due to the particulate matter of the test item and not due to inherent toxicity.  No data on repeated dose toxicity after dermal exposure are available. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8917e883-e6fd-4af6-9125-b82c2e70dd6c/documents/5530696e-4c60-4761-83e6-c07c5bc6e947_dc55192a-235e-44c2-8ffa-fecc52bc5cdc.html,,,,,, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]",6358-85-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8917e883-e6fd-4af6-9125-b82c2e70dd6c/documents/5530696e-4c60-4761-83e6-c07c5bc6e947_dc55192a-235e-44c2-8ffa-fecc52bc5cdc.html,Chronic toxicity – systemic effects,oral,NOAEL,550 mg/kg bw/day,,rat "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]",6358-85-6,"Oral LD50 values for Diarylide Yellow Pigment 12 are > 2000 mg/kg bw, the limit for classification. No lethality was observed after acute inhalation exposure to the maximum technically feasible test concentration of 4.3 mg/L Pigment Yellow 13 (structural analogue) No lethality was observed after single dermal application of 1710 mg/kg bw Pigment Yellow 13 (structural analogue). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable without restriction Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): reliable ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8917e883-e6fd-4af6-9125-b82c2e70dd6c/documents/4a5faf41-44e7-4e7f-91d1-324a14733247_dc55192a-235e-44c2-8ffa-fecc52bc5cdc.html,,,,,, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]",6358-85-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8917e883-e6fd-4af6-9125-b82c2e70dd6c/documents/4a5faf41-44e7-4e7f-91d1-324a14733247_dc55192a-235e-44c2-8ffa-fecc52bc5cdc.html,,oral,LD50,"2,228 mg/kg bw",no adverse effect observed, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]",6358-85-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8917e883-e6fd-4af6-9125-b82c2e70dd6c/documents/4a5faf41-44e7-4e7f-91d1-324a14733247_dc55192a-235e-44c2-8ffa-fecc52bc5cdc.html,,dermal,LD50,"1,710 mg/kg bw",no adverse effect observed, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]",6358-85-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8917e883-e6fd-4af6-9125-b82c2e70dd6c/documents/4a5faf41-44e7-4e7f-91d1-324a14733247_dc55192a-235e-44c2-8ffa-fecc52bc5cdc.html,,inhalation,LC50,"> 4,250 mg/m3",no adverse effect observed, 2-[(4-chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide,13515-40-7," A 90-day toxicity study in Fischer F344 rats was performed with the test item. Groups of 10 male and 10 female rats received 0, 50, 200 and 1000 mg/kg/day by oral gavage in corn oil for 90 days. The study included additional control and high dose groups of 6 males and 6 females each analyzed after a 4-week recovery period. All animals survived until scheduled termination without any toxic signs in life. In haematology, clinical biochemistry and urinalysis some scattered significant differences, altogether without a clear dose response and all only minor in severity, were noted. Post mortem examination including histopathology did not reveal any test substance related toxic alterations. The test substance caused elevated liver weights in the high dosed females. As there were no corresponding histopathological or clinical-biochemical alterations found, the most likely interpretation is an adaptive response by enzyme induction. No parallel trend was present in the males. The effects did not persist until the end of the recovery period. No other test substance-related effect was noted. The No-observed-adverse-effect-level (NOAEL) of the test item was 1000 mg/kg bw/day in both sexes. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba95a582-4621-4113-9383-6e045599d506/documents/a80c7eee-00e0-47f6-ac80-3a1168356733_fe2fd31b-cebb-425f-9bc8-3f1b4a616bab.html,,,,,, 2-[(4-chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide,13515-40-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba95a582-4621-4113-9383-6e045599d506/documents/a80c7eee-00e0-47f6-ac80-3a1168356733_fe2fd31b-cebb-425f-9bc8-3f1b4a616bab.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-[(4-chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide,13515-40-7," Ten female Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage at a dose of 5000 mg/kg bw. No clinical signs of toxicity were observed. Faeces were yellow-coloured in all animals. Body weight development was not impaired. Animals killed at the end of the observation period showed no macroscopically visible changes. No animal died during the 14 day observation period, resulting in a LD50 > 5000 mg/kg bw. The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba95a582-4621-4113-9383-6e045599d506/documents/4893c010-7084-47a5-bc95-4df5745360ee_fe2fd31b-cebb-425f-9bc8-3f1b4a616bab.html,,,,,, 2-[(4-chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide,13515-40-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba95a582-4621-4113-9383-6e045599d506/documents/4893c010-7084-47a5-bc95-4df5745360ee_fe2fd31b-cebb-425f-9bc8-3f1b4a616bab.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, 2-[(4-chloro-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide,13515-40-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba95a582-4621-4113-9383-6e045599d506/documents/4893c010-7084-47a5-bc95-4df5745360ee_fe2fd31b-cebb-425f-9bc8-3f1b4a616bab.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,6,6-trimethylbicyclo[3.1.1]heptane-3-carbaldehyde",60113-43-1,"LD50, rat, oral (gavage) = 2000 mg/kg (BASF AG, 1985)Inhalation Hazard Test: No mortality was observed after inhalation of a highly saturated vapor-air-mixture for 7 hours in rats (BASF AG, 1986) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c69f8d1-6ecc-4d94-90bd-e082e51924ee/documents/IUC5-ea33ff48-74eb-428b-b49c-bd1360a6a472_85a51425-14d4-4179-b973-361d718e8a31.html,,,,,, Pin-2(3)-ene,80-56-8, 90-day repeated dose toxicity study by inhalation: NOAEC for male rats = 100 ppm 90-day repeated dose toxicity study by inhalation: NOAEC for female rats = 200 ppm 90-day repeated dose toxicity study by inhalation: NOAEC for female mice = 50 ppm 90-day repeated dose toxicity study by inhalation: LOAEC for male mice = 100 ppm 4-week repeated dose toxicity by oral route: NOAEC for male and female rats = 12 000 ppm (higher dose tested) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b8b2a379-3461-4755-bed1-d5076c636229/documents/a9a1a9a9-6ba2-4c12-8bf9-daddc7e06072_1192500a-ccf9-4c8e-8e60-6e7df3a4b2d6.html,,,,,, Pin-2(3)-ene,80-56-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b8b2a379-3461-4755-bed1-d5076c636229/documents/a9a1a9a9-6ba2-4c12-8bf9-daddc7e06072_1192500a-ccf9-4c8e-8e60-6e7df3a4b2d6.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,566.5 mg/m3,,mouse Pin-2(3)-ene,80-56-8, In a GLP study conducted according to the OECD 423 guideline the oral LD50 cut-off value (rats) was 500 mg/kg bw. In a GLP study conducted according to the OECD 402 guideline the dermal LD50 (rats) was higher than 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8b2a379-3461-4755-bed1-d5076c636229/documents/421c3392-76af-42d3-addc-3d52b89f7170_1192500a-ccf9-4c8e-8e60-6e7df3a4b2d6.html,,,,,, Pin-2(3)-ene,80-56-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8b2a379-3461-4755-bed1-d5076c636229/documents/421c3392-76af-42d3-addc-3d52b89f7170_1192500a-ccf9-4c8e-8e60-6e7df3a4b2d6.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Pin-2(3)-ene,80-56-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8b2a379-3461-4755-bed1-d5076c636229/documents/421c3392-76af-42d3-addc-3d52b89f7170_1192500a-ccf9-4c8e-8e60-6e7df3a4b2d6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Pine, Pinus mugo, ext.",90082-72-7,"Acute toxicity, oral: LD50 > 5000 mg/kg bw (K, Rel.2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1da4f814-0c4f-44a2-bd48-96a7281af453/documents/b8f53b8c-3cd2-4d88-bb51-6c081b9312c1_debb6d90-6670-4371-930e-9f850ab6d15e.html,,,,,, "Pine, Pinus mugo, ext.",90082-72-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1da4f814-0c4f-44a2-bd48-96a7281af453/documents/b8f53b8c-3cd2-4d88-bb51-6c081b9312c1_debb6d90-6670-4371-930e-9f850ab6d15e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Pine, Pinus pinaster, ext.",90082-75-0,"Acute toxicity, oral: LD50 (rat) > 2000 mg/kg bw (K, Rel.1). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a00b7dd1-8a56-4521-91c5-9cb147a4f6ba/documents/IUC5-9d154a1c-5144-48a3-8367-57fa89c24827_e6f3fffe-1d04-4c9f-bc04-b8d11928ec58.html,,,,,, "Pine, Pinus pinaster, ext.",90082-75-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a00b7dd1-8a56-4521-91c5-9cb147a4f6ba/documents/IUC5-9d154a1c-5144-48a3-8367-57fa89c24827_e6f3fffe-1d04-4c9f-bc04-b8d11928ec58.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Pine, Pinus sylvestris, ext.",84012-35-1,"Acute toxicity, oral: LD50 > 5000 mg/kg bw (K, Rel.2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecaa33c6-34bd-44ba-8b03-c7932dfee504/documents/4bf86cba-9f8e-4228-b52f-837e2e1170b4_252f0e24-ffee-48cb-9bd1-9a3d8ab7b16c.html,,,,,, "Pine, Pinus sylvestris, ext.",84012-35-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecaa33c6-34bd-44ba-8b03-c7932dfee504/documents/4bf86cba-9f8e-4228-b52f-837e2e1170b4_252f0e24-ffee-48cb-9bd1-9a3d8ab7b16c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Pepper (Piper), P. nigrum, ext.",84929-41-9,"Acute toxicity, oral in rats: LD50 > 5000 mg/kg bw (equivalent or similar to OECD 401, non-GLP, K, Rel.2) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de3b9ae9-b3f6-4607-8ac0-8cf5a28d1bc7/documents/f273f4aa-59d9-4082-9c58-b8ee92979e79_fa4000e0-990e-49e9-ad88-318c1a7f9716.html,,,,,, "Pepper (Piper), P. nigrum, ext.",84929-41-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de3b9ae9-b3f6-4607-8ac0-8cf5a28d1bc7/documents/f273f4aa-59d9-4082-9c58-b8ee92979e79_fa4000e0-990e-49e9-ad88-318c1a7f9716.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 6-isopropyl-3-methylcyclohex-2-enone,89-81-6,The acute oral toxicity of the test substance was assessed. The acute oral LD50 was 3.55 g/kg with 95 % confidence limits of 2.45 – 4.65 g/kg. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ce4248b-19e4-49f3-b64f-87d95f05b95e/documents/IUC5-35c24db1-5924-45d6-aeeb-56867016d19f_3999b5fb-7301-483f-b094-ebf54ae713a5.html,,,,,, 6-isopropyl-3-methylcyclohex-2-enone,89-81-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ce4248b-19e4-49f3-b64f-87d95f05b95e/documents/IUC5-35c24db1-5924-45d6-aeeb-56867016d19f_3999b5fb-7301-483f-b094-ebf54ae713a5.html,,oral,LD50,"3,550 mg/kg bw",adverse effect observed, 6-isopropyl-3-methylcyclohex-2-enone,89-81-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ce4248b-19e4-49f3-b64f-87d95f05b95e/documents/IUC5-35c24db1-5924-45d6-aeeb-56867016d19f_3999b5fb-7301-483f-b094-ebf54ae713a5.html,,dermal,LD50,5 mg/kg bw,no adverse effect observed, 2-(2-butoxyethoxy)ethyl 6-propylpiperonyl ether,51-03-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Klimish score: 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimish score: 1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff1a9a01-787e-4f3b-93eb-b4657614f4b1/documents/IUC5-7c8730bf-a504-45ff-8b34-fa9782ee238a_f5892059-971d-4988-971a-54ab9831420e.html,,,,,, 2-(2-butoxyethoxy)ethyl 6-propylpiperonyl ether,51-03-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff1a9a01-787e-4f3b-93eb-b4657614f4b1/documents/IUC5-7c8730bf-a504-45ff-8b34-fa9782ee238a_f5892059-971d-4988-971a-54ab9831420e.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rabbit 2-(2-butoxyethoxy)ethyl 6-propylpiperonyl ether,51-03-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff1a9a01-787e-4f3b-93eb-b4657614f4b1/documents/IUC5-7c8730bf-a504-45ff-8b34-fa9782ee238a_f5892059-971d-4988-971a-54ab9831420e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15.5 mg/kg bw/day,,dog 2-(2-butoxyethoxy)ethyl 6-propylpiperonyl ether,51-03-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff1a9a01-787e-4f3b-93eb-b4657614f4b1/documents/IUC5-7c8730bf-a504-45ff-8b34-fa9782ee238a_f5892059-971d-4988-971a-54ab9831420e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,155 mg/m3,,rat "1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)",68890-66-4,"Octopirox was investigated for potential systemic effects in repeated dose toxicity studies (subacute, subchronic, chronic) in rats and dogs following oral and dermal exposure. In all of these in-life toxicity studies the no-adverse-effect-level (NOAEL) was consistently placed at or above 100 mg/kg body weight. In addition, in none of these studies Octopirox exhibited any symptomatology which gives evidence for a specific target organ toxic effect. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b1947dd-273e-4f80-8329-a63c2b1b44a7/documents/IUC5-e11ac2c3-2f5c-4b5a-b68f-2311e42d264e_33621010-9217-4fc6-8b75-bc03205fb11d.html,,,,,, "1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)",68890-66-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b1947dd-273e-4f80-8329-a63c2b1b44a7/documents/IUC5-e11ac2c3-2f5c-4b5a-b68f-2311e42d264e_33621010-9217-4fc6-8b75-bc03205fb11d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,, "1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)",68890-66-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b1947dd-273e-4f80-8329-a63c2b1b44a7/documents/IUC5-e11ac2c3-2f5c-4b5a-b68f-2311e42d264e_33621010-9217-4fc6-8b75-bc03205fb11d.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,, "1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)",68890-66-4,"The acute toxicity of Octopirox was investigated following oral exposure in rats and dogs as well as after dermal and inhalation exposure was in rats. Independent of the species and/or sex tested and exposure route used, Octopirox was practically non-toxic. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b1947dd-273e-4f80-8329-a63c2b1b44a7/documents/IUC5-df4ed065-a13f-4f68-a160-3abf79063b11_33621010-9217-4fc6-8b75-bc03205fb11d.html,,,,,, "1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)",68890-66-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b1947dd-273e-4f80-8329-a63c2b1b44a7/documents/IUC5-df4ed065-a13f-4f68-a160-3abf79063b11_33621010-9217-4fc6-8b75-bc03205fb11d.html,,oral,LD50,"8,100 mg/kg bw",, "1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)",68890-66-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b1947dd-273e-4f80-8329-a63c2b1b44a7/documents/IUC5-df4ed065-a13f-4f68-a160-3abf79063b11_33621010-9217-4fc6-8b75-bc03205fb11d.html,,dermal,LD50,"2,000 mg/kg bw",, "1-hydroxy-4-methyl-6-(2,4,4-trimethylpentyl)pyridin-2(1H)-one, compound with 2-aminoethanol (1:1)",68890-66-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b1947dd-273e-4f80-8329-a63c2b1b44a7/documents/IUC5-df4ed065-a13f-4f68-a160-3abf79063b11_33621010-9217-4fc6-8b75-bc03205fb11d.html,,inhalation,LC50,"4,900 mg/m3",, "Linseed oil, polymerized",67746-08-1," In a combined repeated dose toxicity/reproscreening study, which was performed in accordance with OECD 421 and under GLP-conditions, standolized linseed oil was administered by daily oral gavage to male and female Wistar Han rats at dose levels of 150, 450 and 1000 mg/kg/day. Males were exposed for 2 weeks prior to mating, during mating, and up to termination (for 29 days). The females were exposed for 2 weeks prior to mating, during mating, during post-coitum, and at least 4 days of lactation (for 42-45 days). No chemical analyses were conducted, since no analytical method could be developed for formulations of the test substance in corn oil. No parental toxicity attributable to treatment with Standolized linseed oil was observed at any dose level. One female at 1000 mg/kg (Group 4) had a total litter loss and was euthanized in extremis on Day 2 of the lactation period. At histopathology, severe atrophy of the lympho-hemopoeitic system was determined to be the cause of morbidity for this animal. This was considered to be spontaneous in nature. In the absence of similar findings in any other animal, it was not considered to be treatment related, and her total litter loss was considered to be secondary to the poor health of the dam. A number of clinical biochemistry changes were noted at 450 and/or 1000 mg/kg which included higher bilirubin, creatinine and sodium levels in blood. In addition, liver to body weight ratios were increased for both sexes at 1000 mg/kg. Means of these changes only just exceeded or remained within the range considered normal for rats of this age and strain. Moreover, there were no histopathological correlates that would support these changes. Therefore, these changes were considered not to be of toxicological relevance. Overall, no toxicologically relevant changes were noted in any of the parental parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). In conclusion, treatment with standolized linseed oil by oral gavage in male and female Wistar Han rats at dose levels of 150, 450 and 1000 mg/kg body weight/day revealed no parental toxicity up to 1000 mg/kg body weight/day. Based on these results, a No Observed Adverse Effect Levels (NOAEL) of at least 1000 mg/kg/day was derived. Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint: One study available which was performed in accordance with OECD-guidelines and under GLP-conditions ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba67f654-2ad1-4601-8467-150d97356269/documents/IUC5-73009eb7-e633-44b8-871b-2eefbef5ba50_a6e3a6bd-7442-42a7-afe7-7a4d7ab490e2.html,,,,,, "Linseed oil, polymerized",67746-08-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba67f654-2ad1-4601-8467-150d97356269/documents/IUC5-73009eb7-e633-44b8-871b-2eefbef5ba50_a6e3a6bd-7442-42a7-afe7-7a4d7ab490e2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Linseed oil, polymerized",67746-08-1,"Acute toxicity:- Oral (OECD 401, GLP): LD50 >4897 mg/kg bw- Dermal (OECD 402, GLP): LD50 >2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba67f654-2ad1-4601-8467-150d97356269/documents/IUC5-d92cd7c6-fe25-4b1d-936f-ce4ec2b7dede_a6e3a6bd-7442-42a7-afe7-7a4d7ab490e2.html,,,,,, "Linseed oil, polymerized",67746-08-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba67f654-2ad1-4601-8467-150d97356269/documents/IUC5-d92cd7c6-fe25-4b1d-936f-ce4ec2b7dede_a6e3a6bd-7442-42a7-afe7-7a4d7ab490e2.html,,oral,LD50,"4,897 mg/kg bw",no adverse effect observed, "Linseed oil, polymerized",67746-08-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba67f654-2ad1-4601-8467-150d97356269/documents/IUC5-d92cd7c6-fe25-4b1d-936f-ce4ec2b7dede_a6e3a6bd-7442-42a7-afe7-7a4d7ab490e2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Butene, homopolymer (products derived from either/or But-1-ene/But-2-ene)",9003-29-6,"There is a 28 day repeat oral dosing study with triisobutylene with 14 day recovery. There are also repeat dose toxicity studies with other higher olefins spanning the range C8 to C20. The data for these studies indicate that the location of the double bond or the addition of branching to the structure do not appear to affect the toxicity. Higher olefins are of low toxicity in rats. Male rat kidney effects indicative of alpha-2u-globulin nephropathy consistently occur with the C8 to C14 higher olefins. Alpha-2u-globulin nephropathy is considered to be male rat-specific and is not relevant for humans. Treatment-related liver effects (increased organ weights, hepatocyte cytoplasmic vacuolation, and centrilobular hepatocyte hypertrophy) are also observed in rats exposed to higher olefins, which may reflect adaptive changes as a result of the high liver burden of these substances. There is no evidence of neurotoxicity. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ddaa6c12-79cd-4709-a907-abff0dbe8c60/documents/IUC5-ae181e9c-6f53-45e7-b0bd-f6a8521b6ae7_635a51d2-62af-44f1-b91b-a2752eceed08.html,,,,,, "Butene, homopolymer (products derived from either/or But-1-ene/But-2-ene)",9003-29-6,"Acute toxicity studies exist for higher olefins including butylene oligomers at both ends of the carbon number ranges within this category. The results are consistent throughout the category and indicate low acute toxicity by the oral, dermal and inhalation routes of exposure. Butylene oligomers have low kinematic viscosity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ddaa6c12-79cd-4709-a907-abff0dbe8c60/documents/IUC5-8b0e8e36-1e21-4ab5-a872-e336ab2f055c_635a51d2-62af-44f1-b91b-a2752eceed08.html,,,,,, "1,2,3-Propanetriol, homopolymer, diisooctadecanoate",63705-03-3,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.Repeated dose toxicity: Oral NOAEL (rat, m/f): >1000 mg/kg bw/day (OECD 422) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises adequate, reliable (Klimisch score 2) studies from reference substances with similar structure and intrinsic properties. Read-across is justified based on common origin, common precursors and breakdown products of hydrolysis and consistent trends in environmental fate, ecotoxicological and toxicological profile (refer to endpoint discussion for further details). The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.6, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/073f6b03-bf03-4ab8-83dd-9cf4facbb504/documents/IUC5-60cd7ae8-7398-417e-8111-afb94d3960e8_b0fbc6da-e692-444d-a1b9-b1fdaf59cf73.html,,,,,, "1,2,3-Propanetriol, homopolymer, diisooctadecanoate",63705-03-3," The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.Acute toxicity: Oral LD50 (rat, m/f): > 5000 mg/kg bw (OECD 401, GLP)Acute toxicity: Dermal LD50 (rat, m/f): > 5000 mg/kg bw (OECD 402, GLP)Acute toxicity: Inhalation LC50 (rat, m/f): > 5.0 and 1.86 mg/mL (highest attainable concentrations, OECD 403, GLP, analogue approach) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/073f6b03-bf03-4ab8-83dd-9cf4facbb504/documents/IUC5-acf4fd4f-cea7-49fa-a6a4-90043d2cb9b3_b0fbc6da-e692-444d-a1b9-b1fdaf59cf73.html,,,,,, "Oleic acid, monoester with oxybis(propanediol)",49553-76-6," The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.Repeated dose toxicity: Oral NOAEL (rat, m/f): >1000 mg/kg bw/day (OECD 407 and 408, analogue approach) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1b6fc2b-5e16-4106-a243-38eb93a06074/documents/IUC5-0ba27731-00b5-4ff4-8327-3e7d4ed56c11_f9b94d1e-2b4f-43b7-b5b4-70ab96d4fb4c.html,,,,,, "Oleic acid, monoester with oxybis(propanediol)",49553-76-6," The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401, GLP, analogue approach)Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, GLP, analogue approach)Acute toxicity: Inhalation LC50 (rat, m/f): > 5.0 mg/L air (OECD 403, analogue approach) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1b6fc2b-5e16-4106-a243-38eb93a06074/documents/IUC5-a9d724e8-049c-4458-9fa4-f185f48fd47f_f9b94d1e-2b4f-43b7-b5b4-70ab96d4fb4c.html,,,,,, "1,2,3-Propanetriol, oligomers, docosanoate",64366-79-6,"In a reproduction/developmental toxicity screening test (OECD TG 422) the NOAEL (no observed adverse effect level) for reproductive performance and fertility was 1000 mg/kg bw/d. The NOAEL for developmental toxicity in the F1 progeny was found to be 1000 mg/kg bw/d. The NOAEL for general, systemic toxicity was 1000 mg/kg bw/d. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0980e8f-3bdd-48b2-aef7-da0919e4d4ad/documents/IUC5-02cb559f-7ae6-4df3-8653-36635879a2eb_c890c434-e25b-4a54-ae63-599dc25ee06a.html,,,,,, "1,2,3-Propanetriol, oligomers, docosanoate",64366-79-6,In an acute oral toxicity study the LD50 value was determined to be > 2000 mg/kg bw. In an acute dermal toxicity study the LD50 value was > 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0980e8f-3bdd-48b2-aef7-da0919e4d4ad/documents/IUC5-453b38df-1405-4f10-85ee-4fcecf703932_c890c434-e25b-4a54-ae63-599dc25ee06a.html,,,,,, "Alpha-dodecyl-omega-hydroxy-poly[oxy(hydroxymethyl)-1,2-ethanediyl]",9022-75-7,"In a 4-week oral toxicity study performed similarly to OECD guideline 407 and in compliance with GLP, a NOAEL was identified at 150 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e262416-9fe0-491a-9baf-d9a7c371ce5e/documents/IUC5-a30d23e0-30fe-4022-bd33-bf5012b1744d_f07dc9d9-e193-416f-919a-322614d09cdb.html,,,,,, "Alpha-dodecyl-omega-hydroxy-poly[oxy(hydroxymethyl)-1,2-ethanediyl]",9022-75-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e262416-9fe0-491a-9baf-d9a7c371ce5e/documents/IUC5-a30d23e0-30fe-4022-bd33-bf5012b1744d_f07dc9d9-e193-416f-919a-322614d09cdb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Alpha-dodecyl-omega-hydroxy-poly[oxy(hydroxymethyl)-1,2-ethanediyl]",9022-75-7,"LD50>2000 mg/kg bw in a limit test by oral route (OECD 423, rel. 1, GLP).LD50>2000 mg/kg bw in a limit test by dermal route (OECD 402, rel. 1, GLP). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e262416-9fe0-491a-9baf-d9a7c371ce5e/documents/IUC5-2fc3d27d-5c2a-4eaf-b6a4-8532d57a259f_f07dc9d9-e193-416f-919a-322614d09cdb.html,,,,,, "Alpha-dodecyl-omega-hydroxy-poly[oxy(hydroxymethyl)-1,2-ethanediyl]",9022-75-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e262416-9fe0-491a-9baf-d9a7c371ce5e/documents/IUC5-2fc3d27d-5c2a-4eaf-b6a4-8532d57a259f_f07dc9d9-e193-416f-919a-322614d09cdb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Alpha-dodecyl-omega-hydroxy-poly[oxy(hydroxymethyl)-1,2-ethanediyl]",9022-75-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e262416-9fe0-491a-9baf-d9a7c371ce5e/documents/IUC5-2fc3d27d-5c2a-4eaf-b6a4-8532d57a259f_f07dc9d9-e193-416f-919a-322614d09cdb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "6-methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide, potassium salt",55589-62-3,"The chronic oral toxicity of Acesulfame potassium was investigated in male and female Beagle dogs. Each 4 males and 4 females received dose levels of 0, 0.3%, 1.0% and 3.0% in the diet (0, 3000, 10000, 30000 ppm, corresponding to about 0, 90, 300 and 900 mg/kg bw/day) daily during a period of two years. The no observed adverse effects level (NOAEL) for chronic (2 year) oral toxicity in male and female Beagle dogs was 30000 ppm (corresponding to about 900 mg/kg bw/day). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa1b3414-91d2-4d86-8171-845bb9162092/documents/IUC5-f27bee44-43bf-48f0-ab51-3d9b85678640_d43f8e80-c5ea-4387-b5eb-0153ffd8e97b.html,,,,,, "6-methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide, potassium salt",55589-62-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa1b3414-91d2-4d86-8171-845bb9162092/documents/IUC5-f27bee44-43bf-48f0-ab51-3d9b85678640_d43f8e80-c5ea-4387-b5eb-0153ffd8e97b.html,Chronic toxicity – systemic effects,oral,NOAEL,900 mg/kg bw/day,,dog "6-methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide, potassium salt",55589-62-3,"In rats, the oral LD50 values and 95% confidence limits were 5438 (4839-5994) mg/kg bw for males and 5565 (5083-6071) mg/kg bw for females, while the dermal LD50 value was >2000 mg/kg bw. In mice, the oral LD50 values and 95% confidence limits were 5438 (4839-5994) mg/kg bw for males and 5565 (5083-6071) mg/kg bw for females.No standard study on acute toxicity after inhalation is available. However, no inhalation toxicity of thermal degradation products tested at 250 °C was noted. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa1b3414-91d2-4d86-8171-845bb9162092/documents/IUC5-96efd19c-4ac5-4068-93ef-f3b4b7a37dfd_d43f8e80-c5ea-4387-b5eb-0153ffd8e97b.html,,,,,, "6-methyl-1,2,3-oxathiazin-4(3H)-one 2,2-dioxide, potassium salt",55589-62-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa1b3414-91d2-4d86-8171-845bb9162092/documents/IUC5-96efd19c-4ac5-4068-93ef-f3b4b7a37dfd_d43f8e80-c5ea-4387-b5eb-0153ffd8e97b.html,,oral,LD50,"5,534 mg/kg bw",no adverse effect observed, Potassium acetate,127-08-2,"Repeated dose toxicity: oral:Weight of evidence: Read-across from experimental results from no-standard studies on rats with Sodium Acetate and Citric acid, sodium salt. All these studies showed no signs of toxicity, even though in one study, the limit dose was exceeded. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6237b23-1beb-4379-aff3-e644a83c07ff/documents/IUC5-8be7a801-998e-4fd8-84e5-942edf4d52df_1262d466-01c4-49f2-a244-bafc3add94b7.html,,,,,, Potassium acetate,127-08-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6237b23-1beb-4379-aff3-e644a83c07ff/documents/IUC5-8be7a801-998e-4fd8-84e5-942edf4d52df_1262d466-01c4-49f2-a244-bafc3add94b7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"4,307.01 mg/kg bw/day",,rat Potassium acetate,127-08-2,Acute oral toxicity: Key study: The oral LD50 in male rats was 3.25 (2.48-4.26) g/kg bw (no specific test guideline was reported).Acute inhalation toxicity: Key study: Read-across from experimental data on the category analogue Calcium acetate. The LC50 for substance Potassium Acetate is calculated to be higher than 6.95 mg/L air under test conditions.Acute dermal toxicity: Key study: Read-across from experimental data on the analogue Fumaric Acid. The LD 50 for Potassium Acetate is calculated to be greater than 33820.97 mg/kg bw under test conditions. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6237b23-1beb-4379-aff3-e644a83c07ff/documents/IUC5-929bd76f-0c1f-4f31-8ae9-f3fe6ef78d61_1262d466-01c4-49f2-a244-bafc3add94b7.html,,,,,, Potassium acetate,127-08-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6237b23-1beb-4379-aff3-e644a83c07ff/documents/IUC5-929bd76f-0c1f-4f31-8ae9-f3fe6ef78d61_1262d466-01c4-49f2-a244-bafc3add94b7.html,,oral,LD50,"3,250 mg/kg bw",, Potassium acetate,127-08-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6237b23-1beb-4379-aff3-e644a83c07ff/documents/IUC5-929bd76f-0c1f-4f31-8ae9-f3fe6ef78d61_1262d466-01c4-49f2-a244-bafc3add94b7.html,,dermal,LD50,"33,820.97 mg/kg bw",, Potassium acetate,127-08-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6237b23-1beb-4379-aff3-e644a83c07ff/documents/IUC5-929bd76f-0c1f-4f31-8ae9-f3fe6ef78d61_1262d466-01c4-49f2-a244-bafc3add94b7.html,,inhalation,LC50,"6,950 mg/m3",, Aluminium potassium bis(sulphate),10043-67-1,NOAEL-20 month chronic oral systemic toxicity mouse: 8160 mg/kg bw/d Aluminium potassium bis sulphate NOAEC-86 weeks chronic inhalative systemic toxicity rat: 6.2 mg/m³ Aluminium potassium bis sulphate (calculated)NOAEL-43 days subchronic dermal systemic toxicity human: 8.52 mg /kg bw/d Aluminium potassium bis sulphate (calculated) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce1166ac-7d80-48ed-906d-2b3a46313f6e/documents/IUC5-d5c30869-8fc1-426a-8f8d-7e55bbc7144e_f8994129-615e-4a9a-9ddf-dce92fa3d56b.html,,,,,, Aluminium potassium bis(sulphate),10043-67-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce1166ac-7d80-48ed-906d-2b3a46313f6e/documents/IUC5-d5c30869-8fc1-426a-8f8d-7e55bbc7144e_f8994129-615e-4a9a-9ddf-dce92fa3d56b.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,8.52 mg/kg bw/day,,other:human Aluminium potassium bis(sulphate),10043-67-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce1166ac-7d80-48ed-906d-2b3a46313f6e/documents/IUC5-d5c30869-8fc1-426a-8f8d-7e55bbc7144e_f8994129-615e-4a9a-9ddf-dce92fa3d56b.html,Chronic toxicity – systemic effects,oral,NOAEL,"8,160 mg/kg bw/day",,mouse Aluminium potassium bis(sulphate),10043-67-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce1166ac-7d80-48ed-906d-2b3a46313f6e/documents/IUC5-d5c30869-8fc1-426a-8f8d-7e55bbc7144e_f8994129-615e-4a9a-9ddf-dce92fa3d56b.html,Chronic toxicity – systemic effects,inhalation,NOAEC,6.2 mg/m3,,rat Aluminium potassium bis(sulphate),10043-67-1,"Based on the long-term key study from Oneda et al. the calculated LD50-mouse oral should be > 2000 mg/kg bw.This result was used for classification of the substance. Based on the oral NOAEL value of the key study the inhalative NOAEL of the substance was calculated.NOAEL inhalative calculated from NOAEL oral:NOAEL inhalative = 13.05 mg/m³. The calculated LC50-inhalative should be > 5 mg/L (Limit CLP).Based on the key study ( ATSDR report and publication of Lansdown) the calculated LD50-dermal of aluminium potassium bis sulphate from read across substance aluminium sulfate resulted in a calculated LD50-dermal of 100000 mg/kg bw aluminium potassium bis sulphate.Based on all acute toxicity results aluminium potassium bis sulphate is not classified as acute toxic oral, inhalative and dermal according EU regulation 1272/2008 and EU regulation 286/2011 (2. ATP). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce1166ac-7d80-48ed-906d-2b3a46313f6e/documents/IUC5-f50e7363-09fe-4f26-85c9-5ca5b4d22806_f8994129-615e-4a9a-9ddf-dce92fa3d56b.html,,,,,, Aluminium potassium bis(sulphate),10043-67-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce1166ac-7d80-48ed-906d-2b3a46313f6e/documents/IUC5-f50e7363-09fe-4f26-85c9-5ca5b4d22806_f8994129-615e-4a9a-9ddf-dce92fa3d56b.html,,oral,LD50,"8,160 mg/kg bw",no adverse effect observed, Aluminium potassium bis(sulphate),10043-67-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce1166ac-7d80-48ed-906d-2b3a46313f6e/documents/IUC5-f50e7363-09fe-4f26-85c9-5ca5b4d22806_f8994129-615e-4a9a-9ddf-dce92fa3d56b.html,,dermal,LD50,"100,000 mg/kg bw",no adverse effect observed, Aluminium potassium bis(sulphate),10043-67-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce1166ac-7d80-48ed-906d-2b3a46313f6e/documents/IUC5-f50e7363-09fe-4f26-85c9-5ca5b4d22806_f8994129-615e-4a9a-9ddf-dce92fa3d56b.html,,inhalation,LC50,13.05 mg/m3,no adverse effect observed, Potassium benzoate,582-25-2, Benzoate / benzoic acid is considered to be of low toxicity Daily intake of potassium is recommended to be 5 g in adults. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3e24c56-821b-4c75-bd00-ba3c7b85d82a/documents/529468a3-9795-443e-8c2c-effb5b319158_f2864eae-07fe-47bf-9458-3b3f31c5006b.html,,,,,, Potassium benzoate,582-25-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3e24c56-821b-4c75-bd00-ba3c7b85d82a/documents/529468a3-9795-443e-8c2c-effb5b319158_f2864eae-07fe-47bf-9458-3b3f31c5006b.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,090 mg/kg bw/day",,rat Potassium benzoate,582-25-2, Assessment has been made based on the well established toxicity profile of benzoate (specifically sodium benzoate) There is no evidence of toxicity from potassium at concentrations leading to classification. Potassium is an essential element and there is a recommended daily intake of 4700 mg/day for adults (ca 67 mg/kg based on 70 kg adult). The recommended daily intake for children is > 70 mg/kg/day. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3e24c56-821b-4c75-bd00-ba3c7b85d82a/documents/eeeacd97-6820-4705-b585-6c9aada4b115_f2864eae-07fe-47bf-9458-3b3f31c5006b.html,,,,,, Potassium benzoate,582-25-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3e24c56-821b-4c75-bd00-ba3c7b85d82a/documents/eeeacd97-6820-4705-b585-6c9aada4b115_f2864eae-07fe-47bf-9458-3b3f31c5006b.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Potassium benzoate,582-25-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3e24c56-821b-4c75-bd00-ba3c7b85d82a/documents/eeeacd97-6820-4705-b585-6c9aada4b115_f2864eae-07fe-47bf-9458-3b3f31c5006b.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Potassium hydrogencarbonate,298-14-6,"Reliable, adequate and relevant studies on oral repeated dose toxicity of potassium hydrogencarbonate are available. These studies included 4-weeks, 13-weeks, 18-months, and 30-months studies, in which rats were treated with very high doses of potassium hydrogencarbonate in their feed (2 and 4%). The studies were not performed according to an explicitly mentioned international guideline, but accomplishment and documentation cover a broad range of the requirements of the usual guidelines for repeated dose toxicity studies. Thus, the studies are relevant, reliable and adequate for the purpose of assessing repeated dose toxicity. Even the low dose level of this study set exceeds the guideline limit dose for repeated dose toxicity studies to a considerable degree, no treatment related toxic effects relevant to humans were seen.The NOAELs of potassium hydrogencarbonate relevant to humans is the highest dose tested of 4 % in diet, based on body weight and diet intake corresponding to- 6054 mg/kg bw/d (43.8 mmol/kg bw/d) in males and 6137 mg/kg bw/d (44.4 mmol/kg bw/d) in females in the 4-weeks-study- 4326 mg/kg bw/d (31.3 mmol/kg bw/d) in males and 4879 mg/kg bw/d (35.3 mmol/kg bw/d) in females in the 13-weeks-study- 2861 mg/kg bw/d (20.7 mmol/kg bw/d) in males and 3566 mg/kg bw/d (25.8 mmol/kg bw/d) in females in the 18-months study and of- 2667 mg/kg bw/d (19.3 mmol/kg bw/d) in males and 3331 mg/kg bw/d (24.1 mmol/kg bw/d) in females in the 30-months study ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c7d5974-9595-41a8-8e20-f08e5c52c4ef/documents/IUC5-bad6ae3c-978f-4aaa-a4b7-1854c9e3b6bb_f5e904a8-47ce-4cba-8a32-c0eac94a8a86.html,,,,,, Potassium hydrogencarbonate,298-14-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c7d5974-9595-41a8-8e20-f08e5c52c4ef/documents/IUC5-bad6ae3c-978f-4aaa-a4b7-1854c9e3b6bb_f5e904a8-47ce-4cba-8a32-c0eac94a8a86.html,Chronic toxicity – systemic effects,oral,NOAEL,"3,000 mg/kg bw/day",,rat Potassium hydrogencarbonate,298-14-6,"There is no evidence on an intrinsic acute toxic activity of potassium hydrogencarbonate after oral, dermal or inhalation exposure. In rats, the oral and dermal LD50 is > 2000 mg/kg bw and the LC50 is > 4.88 +/- 0.60 mg/L. In addition, absence of intrinsic toxic properties of potassium hydrogencarbonate by oral exposure of humans is generally taken for granted, which is proved by its long-standing safe use in food and pharmaceuticals and its GRAS (generally recognized as safe) status in the USA. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c7d5974-9595-41a8-8e20-f08e5c52c4ef/documents/IUC5-aca1e4c2-d2a5-4e90-9e09-c17e443d5f5e_f5e904a8-47ce-4cba-8a32-c0eac94a8a86.html,,,,,, Potassium hydrogencarbonate,298-14-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c7d5974-9595-41a8-8e20-f08e5c52c4ef/documents/IUC5-aca1e4c2-d2a5-4e90-9e09-c17e443d5f5e_f5e904a8-47ce-4cba-8a32-c0eac94a8a86.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Potassium hydrogencarbonate,298-14-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c7d5974-9595-41a8-8e20-f08e5c52c4ef/documents/IUC5-aca1e4c2-d2a5-4e90-9e09-c17e443d5f5e_f5e904a8-47ce-4cba-8a32-c0eac94a8a86.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Potassium hydrogencarbonate,298-14-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c7d5974-9595-41a8-8e20-f08e5c52c4ef/documents/IUC5-aca1e4c2-d2a5-4e90-9e09-c17e443d5f5e_f5e904a8-47ce-4cba-8a32-c0eac94a8a86.html,,inhalation,LC50,"4,880 mg/m3",no adverse effect observed, Potassium hydrogen phthalate,877-24-7," 1, 2-Benzenedicarboxylic acid, monopotassium salt (CAS no 877-24-7) is likely to be non hazardous by oral route of exposure. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc6a5ea2-b779-41aa-9f4f-769af25ade96/documents/df0ac6c3-4570-4801-aa31-c7bce8632284_500e69b1-906a-45fd-9488-6b00f1559b0f.html,,,,,, Potassium hydrogen phthalate,877-24-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc6a5ea2-b779-41aa-9f4f-769af25ade96/documents/df0ac6c3-4570-4801-aa31-c7bce8632284_500e69b1-906a-45fd-9488-6b00f1559b0f.html,,oral,LD50,"3,200 mg/kg bw",no adverse effect observed, Potassium hydrogen tartrate,868-14-4,Tartaric acid and its salts do not have significant (sub)chronic toxicity. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3aa4d35c-72e9-4167-be1d-5b18a1876644/documents/2a8c1329-dfda-44d6-9ceb-0698a75276c1_6925c8cc-39e6-4660-9290-3ee9bc19c07f.html,,,,,, Potassium hydrogen tartrate,868-14-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3aa4d35c-72e9-4167-be1d-5b18a1876644/documents/2a8c1329-dfda-44d6-9ceb-0698a75276c1_6925c8cc-39e6-4660-9290-3ee9bc19c07f.html,Chronic toxicity – systemic effects,oral,NOAEL,"2,460 mg/kg bw/day",,rat Potassium hydrogen tartrate,868-14-4,Tartaric acid and its salts does not have significant acute toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3aa4d35c-72e9-4167-be1d-5b18a1876644/documents/d04fce80-e023-401f-9296-ffc13b985da3_6925c8cc-39e6-4660-9290-3ee9bc19c07f.html,,,,,, Potassium hydrogen tartrate,868-14-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3aa4d35c-72e9-4167-be1d-5b18a1876644/documents/d04fce80-e023-401f-9296-ffc13b985da3_6925c8cc-39e6-4660-9290-3ee9bc19c07f.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Dipotassium tetraborate,1332-77-0,"A number of sub-chronic and chronic studies on boric acid and disodium tetraborate decahydrate were carried out in rats, mice and dogs. In some cases, these studies are research studies (Weir and Fisher, 1972; Dixon et al, 1976; Seal and Weeth, 1980; Lee et al., 1978; Treinen and Chapin, 1991; Ku et al., 1993), but most support that boron can cause adverse haematological effects and that the main target organ of boron toxicity is the testis. The NOAEL for fertility effects is equivalent to 17.5 mg B/kg bw/day (Weir, 1966) that corresponds to a NOAEL of 94.6 mg dipotassium tetraborate/kg bw (anhydrous, and 123.7 mg dipotassium tetraborate tetrahydrate/kg bw). Based on the sub-acute inhalation study on boron oxide conducted in rats (Wilding, 1960), the NOAEC for systemic effects is equivalent to 146 mg B/m3 that corresponds to a NOAEC of 789 mg dipotassium tetraborate/m3 (anhydrous, and 1032 mg dipotassium tetraborate tetrahydrate/m3). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study meets generally accepted scientific standards with acceptable restrictions. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a233116-ae71-4402-9b89-dbd2fc078c31/documents/a0de62dd-4915-4684-8115-bb2bfd77429c_6c683ca3-519f-4131-9733-7103c273494b.html,,,,,, Dipotassium tetraborate,1332-77-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a233116-ae71-4402-9b89-dbd2fc078c31/documents/a0de62dd-4915-4684-8115-bb2bfd77429c_6c683ca3-519f-4131-9733-7103c273494b.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,789 mg/m3,,rat Dipotassium tetraborate,1332-77-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a233116-ae71-4402-9b89-dbd2fc078c31/documents/a0de62dd-4915-4684-8115-bb2bfd77429c_6c683ca3-519f-4131-9733-7103c273494b.html,Chronic toxicity – systemic effects,oral,NOAEL,94.6 mg/kg bw/day,,rat Dipotassium tetraborate,1332-77-0,"Acute oral studies have been performed with potassium tetraborate, disodium tetraborate, sodium tetraborate pentahydrate, sodium tetraborate decahydrate and boric acid. Acute dermal and inhalation studies have been performed with disodium tetraborate pentahydrate, disodium tetraborate decahydrate and boric acid. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): High quality (there are a lot of reliable studies for different boron species available). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): High quality (there are a lot of reliable studies for different boron species available). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): High quality (there are a lot of reliable studies for different boron species available). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a233116-ae71-4402-9b89-dbd2fc078c31/documents/a205aaa3-31e4-4fdd-b369-237989d4abb7_6c683ca3-519f-4131-9733-7103c273494b.html,,,,,, Dipotassium tetraborate,1332-77-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a233116-ae71-4402-9b89-dbd2fc078c31/documents/a205aaa3-31e4-4fdd-b369-237989d4abb7_6c683ca3-519f-4131-9733-7103c273494b.html,,oral,LD50,"3,690 mg/kg bw",no adverse effect observed, Dipotassium tetraborate,1332-77-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a233116-ae71-4402-9b89-dbd2fc078c31/documents/a205aaa3-31e4-4fdd-b369-237989d4abb7_6c683ca3-519f-4131-9733-7103c273494b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dipotassium tetraborate,1332-77-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a233116-ae71-4402-9b89-dbd2fc078c31/documents/a205aaa3-31e4-4fdd-b369-237989d4abb7_6c683ca3-519f-4131-9733-7103c273494b.html,,inhalation,LC50,"2,030 mg/m3",no adverse effect observed, Potassium carbonate,584-08-7,"No studies on oral repeated dose toxicity of potassium carbonate are available. Reliable studies on oral repeated dose toxicity on closely related read-across substance potassium hydrogencarbonate are available. These studies included 4-week, 13-week, 18-month, and 30-month studies, in which rats were treated with very high doses of potassium hydrogen carbonate in their feed (2 and 4%). The studies were not performed according to an explicitly mentioned international guideline, but accomplishment and documentation cover a broad range of the requirements of the usual guidelines for repeated dose toxicity studies. Thus, the studies are relevant, reliable and adequate for the purpose of assessing repeated dose toxicity. Even the low dose level of this study set exceeds the guideline limit dose for repeated dose toxicity studies to a considerable degree, no treatment related toxic effects relevant to humans were seen.The NOAELs of potassium hydrogencarbonate relevant to humans is the highest dose tested of 4 % in diet, based on body weight and diet intake corresponding to - 6054 mg/kg bw/d (43.8 mmol/kg bw/d) in males and 6137 mg/kg bw/d (44.4 mmol/kg bw/d) in females in the 4-week-study- 4326 mg/kg bw/d (31.3 mmol/kg bw/d) in males and 4879 mg/kg bw/d (35.3 mmol/kg bw/d) in females in the 13-week-study- 2861 mg/kg bw/d (20.7 mmol/kg bw/d) in males and 3566 mg/kg bw/d (25.8 mmol/kg bw/d) in females in the 18-month study and of - 2667 mg/kg bw/d (19.3 mmol/kg bw/d) in males and 3331 mg/kg bw/d (24.1 mmol/kg bw/d) in females in the 30-month studyThe molecular weights of potassium hydrogencarbonate (KHCO3) and potassium carbonate (K2CO3) are 100,12 g and 138, 20 g., respectively.Therefore, with respect to the carbonate moiety, 1000 mg potassium hydrogencarbonate are equivalent to 1380 mg potassium carbonate, and with respect to the potassium moiety, 1000 mg potassium hydrogencarbonate are equivalent to 690 mg potassium carbonate. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e13a24b-731d-4eea-8c88-a29969942626/documents/IUC5-d89ea757-a132-41ad-b82d-13f1ec0c8585_dfb72721-6eaa-4a3b-8066-8f708d1969c9.html,,,,,, Potassium carbonate,584-08-7,"Reliable acute toxicity data are available for the oral, dermal and inhalation route. The oral LD50 (rat) is > 2000 mg/kg bw or in the range of 2000 mg/kg bw and the oral LD50 (mice) is 2570 +/- 142 mg/kg bw, the dermal LD50 (rat) is > 2000 mg/kg and the 4.5 h LC50 (rat) is > 4.96 ± 1.14 mg/L. Local irritation reactions to the alkaline salt at the site of application are theoretically possible and have been actually seen around the mouth, the forelimbs and the eyes but not in the deeper respiratory tract in an acute inhalation study, the skin in the acute dermal toxicity study and in one acute oral study at the stomach and intestines after gavage application of lethal dose levels >/= 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e13a24b-731d-4eea-8c88-a29969942626/documents/IUC5-d5f285a9-cb5f-4295-a8fe-f29b5aeb5b0e_dfb72721-6eaa-4a3b-8066-8f708d1969c9.html,,,,,, Potassium carbonate,584-08-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e13a24b-731d-4eea-8c88-a29969942626/documents/IUC5-d5f285a9-cb5f-4295-a8fe-f29b5aeb5b0e_dfb72721-6eaa-4a3b-8066-8f708d1969c9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Potassium carbonate,584-08-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e13a24b-731d-4eea-8c88-a29969942626/documents/IUC5-d5f285a9-cb5f-4295-a8fe-f29b5aeb5b0e_dfb72721-6eaa-4a3b-8066-8f708d1969c9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Potassium carbonate,584-08-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e13a24b-731d-4eea-8c88-a29969942626/documents/IUC5-d5f285a9-cb5f-4295-a8fe-f29b5aeb5b0e_dfb72721-6eaa-4a3b-8066-8f708d1969c9.html,,inhalation,LC50,"4,960 mg/m3",no adverse effect observed, Pentapotassium bis(peroxymonosulphate) bis(sulphate),70693-62-8,"KMPS triple salt was tested in repeated dose toxicity studies for oral and inhalation toxicity.   Oral administration KMPS triple salt was tested in a 14-days subacute study and in a 13-weeks subchronic study in rats. The NOAEL observed in both studies was 200 mg/kg bw/day.   Inhalation KMPS triple salt was tested in a 14-days subacute inhalation study in rats. The NOAEC observed in this study was 1.4 mg/m³ air. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): study conducted similar to OECD Guideline Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): relibale as the study was conducted comparable to OECD Guideline 412, only males were exposed but this is not considered to have compromised the study results, as male rats were shown to be the more sensitive sex in the acute inhalation toxicity study (please refer to A6.1.3/01, IUCLID section 7.2.2) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable guideline study ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a977d563-e1f2-4269-9037-91735b29c91c/documents/IUC5-4265da44-572a-41c6-b422-750745b59c85_e261844a-18c9-48c2-aeba-175864f6eae7.html,,,,,, Pentapotassium bis(peroxymonosulphate) bis(sulphate),70693-62-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a977d563-e1f2-4269-9037-91735b29c91c/documents/IUC5-4265da44-572a-41c6-b422-750745b59c85_e261844a-18c9-48c2-aeba-175864f6eae7.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,1.4 mg/m3,,rat Pentapotassium bis(peroxymonosulphate) bis(sulphate),70693-62-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a977d563-e1f2-4269-9037-91735b29c91c/documents/IUC5-4265da44-572a-41c6-b422-750745b59c85_e261844a-18c9-48c2-aeba-175864f6eae7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Pentapotassium bis(peroxymonosulphate) bis(sulphate),70693-62-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a977d563-e1f2-4269-9037-91735b29c91c/documents/IUC5-4265da44-572a-41c6-b422-750745b59c85_e261844a-18c9-48c2-aeba-175864f6eae7.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1.4 mg/m3,adverse effect observed,rat Pentapotassium bis(peroxymonosulphate) bis(sulphate),70693-62-8,"Acute toxitity test resultsKMPS (triple salt) was tested in a number of studies for acute toxicity on oral, dermal, and inhalation exposure. The acute oral LD50 and LOAEL for KMPS (triple salt) was determined to be 500 mg/kg bw in the rat.   The acute dermal LD50 and LOAEL was determined to be greater than 2000 mg/kg bw and 2000 mg/kg bw in the rat respectively.   The acute inhalation LC50 (4 h) and LOAEL was determined to be 1850 mg KMPS (triple salt)/m³ and 1250 mg/m³ respectively. In another acute inhalation study the obtained LC50 (4 h) was > 5 mg/L with KMPS (Oxone Monopersulfate). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Guideline conform study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Guideline conform study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Guideline conform study ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a977d563-e1f2-4269-9037-91735b29c91c/documents/IUC5-d904cd39-475d-4eed-be28-e28798878c49_e261844a-18c9-48c2-aeba-175864f6eae7.html,,,,,, Pentapotassium bis(peroxymonosulphate) bis(sulphate),70693-62-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a977d563-e1f2-4269-9037-91735b29c91c/documents/IUC5-d904cd39-475d-4eed-be28-e28798878c49_e261844a-18c9-48c2-aeba-175864f6eae7.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Pentapotassium bis(peroxymonosulphate) bis(sulphate),70693-62-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a977d563-e1f2-4269-9037-91735b29c91c/documents/IUC5-d904cd39-475d-4eed-be28-e28798878c49_e261844a-18c9-48c2-aeba-175864f6eae7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Pentapotassium bis(peroxymonosulphate) bis(sulphate),70693-62-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a977d563-e1f2-4269-9037-91735b29c91c/documents/IUC5-d904cd39-475d-4eed-be28-e28798878c49_e261844a-18c9-48c2-aeba-175864f6eae7.html,,inhalation,LC50,"1,850 mg/m3",adverse effect observed, Potassium hexadecyl hydrogen phosphate,19035-79-1," The substance was orally administered by means of a feed admix to Fü SPF albino rats of both sexes at daily dose levels of 50, 200, and 800 mg per kg bw for a period of 13 consecutive weeks. Animals of a control group received the normal rat maintenance diet without test article. All test groups comprised 10 males and 10 females. Mortality, clinical signs, body weights, feed intake, and water consumption were recorded. The NOAEL was 800 mg/kg bw/day, the highest dose tested. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f99ea4ee-5553-463e-bafd-2d4632633ae4/documents/IUC5-994febd7-9665-487e-a978-bdcc6ff14c1d_c067f4d5-a8a6-4bb5-8524-b87bb8c4777b.html,,,,,, Potassium hexadecyl hydrogen phosphate,19035-79-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f99ea4ee-5553-463e-bafd-2d4632633ae4/documents/IUC5-994febd7-9665-487e-a978-bdcc6ff14c1d_c067f4d5-a8a6-4bb5-8524-b87bb8c4777b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,800 mg/kg bw/day,,rat Potassium hexadecyl hydrogen phosphate,19035-79-1, Potassium hexadecyl hydrogen phosphate was tested for acute toxicity by the oral and dermal routes while performance of a toxicity study by the inhalation route was waived. The studies revealed a LD50 (oral) value of > 5000 mg/kg bw and a LD50 (dermal) of > 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f99ea4ee-5553-463e-bafd-2d4632633ae4/documents/IUC5-83553374-caaa-4608-b53f-b6b6c1222901_c067f4d5-a8a6-4bb5-8524-b87bb8c4777b.html,,,,,, Potassium hexadecyl hydrogen phosphate,19035-79-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f99ea4ee-5553-463e-bafd-2d4632633ae4/documents/IUC5-83553374-caaa-4608-b53f-b6b6c1222901_c067f4d5-a8a6-4bb5-8524-b87bb8c4777b.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Potassium hexadecyl hydrogen phosphate,19035-79-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f99ea4ee-5553-463e-bafd-2d4632633ae4/documents/IUC5-83553374-caaa-4608-b53f-b6b6c1222901_c067f4d5-a8a6-4bb5-8524-b87bb8c4777b.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Potassium chlorate,3811-04-9,"Read-across data from sodium chlorate to assess the repeated dose toxicity of potassium chlorate is justified, because the toxicity is expected to be related to the chlorate ion and not to the sodium or potassium ion.   No data available for potassium chlorate. Cross reading to valid animal studies with sodium chlorate indicate that the overall lowest sub-chronic NOAEL is 100 mg sodium chlorate/kg bw/day, based on effects on erythrocytes. On a molecular weight basis this would be 115 mg potassium chlorate/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8aca6c48-f7bc-4a2c-9ea7-b6e57fef8578/documents/IUC5-23a2f47d-8d80-4463-a9a9-e10f06fa479c_23640f89-4779-4c62-ad83-d48902cc7a46.html,,,,,, Potassium chlorate,3811-04-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8aca6c48-f7bc-4a2c-9ea7-b6e57fef8578/documents/IUC5-23a2f47d-8d80-4463-a9a9-e10f06fa479c_23640f89-4779-4c62-ad83-d48902cc7a46.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,115 mg/kg bw/day,,rat Potassium chlorate,3811-04-9,"Read-across data from sodium chlorate to assess the acute toxicity of potassium chlorate is justified, because the toxicity is expected to be related to the chlorate ion and not to the sodium or potassium ion.   Animal studies with potassium chlorate show a low acute toxicity after inhalation (LC50(4h) > 5.1 mg/L) and dermal (LD50(24h) > 2000 mg/kg bw) exposure. Animal studies with sodium chlorate show a low acute toxicity after inhalation (LC50(4.5h) > 5.59 mg/l), dermal (LD50(24h)  > 2000 mg/kg bw) and oral (LD50 = 4950-6250 mg/kg bw) exposure. An evaluation by the French poison control center of sensitivity of humans to sodium chlorate compared to rats led to the following conclusion: If one considers that 50% methemoglobinemia starts to induce signs that may lead to death in the absence of treatment, the dose would be about 20 g / kg for the whole population and 4.5 g / kg for the most sensitive part is the same range as rats.   Despite the low acute toxicity in animals, potassium chlorate has an harmonised classification (index No. 017-004-00-3, ATP0) as Acute Tox. 4 *, H302 and Acute Tox. 4 *, H332 (* minimum classification for the category) based on human experience indicating that classification of sodium chlorate is justified.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8aca6c48-f7bc-4a2c-9ea7-b6e57fef8578/documents/IUC5-dee6a55e-873b-42fe-a038-9187fc1ce801_23640f89-4779-4c62-ad83-d48902cc7a46.html,,,,,, Potassium chlorate,3811-04-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8aca6c48-f7bc-4a2c-9ea7-b6e57fef8578/documents/IUC5-dee6a55e-873b-42fe-a038-9187fc1ce801_23640f89-4779-4c62-ad83-d48902cc7a46.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Potassium chlorate,3811-04-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8aca6c48-f7bc-4a2c-9ea7-b6e57fef8578/documents/IUC5-dee6a55e-873b-42fe-a038-9187fc1ce801_23640f89-4779-4c62-ad83-d48902cc7a46.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Potassium chlorate,3811-04-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8aca6c48-f7bc-4a2c-9ea7-b6e57fef8578/documents/IUC5-dee6a55e-873b-42fe-a038-9187fc1ce801_23640f89-4779-4c62-ad83-d48902cc7a46.html,,inhalation,LC50,5 ,no adverse effect observed, Tripotassium citrate,866-84-2,"Read across from a fairly limited reliable report of a non-standard oral feeding study using citric acid in the rat, conducted without GLP compliance, identified 5-day NOAEL values in the rat of 4000 mg/kg bw/day (which corresponds to 6360 mg tri potassium citrate/kg (bw)/d*). (Hoffman, 1976; rel 2) In addition read across from a fairly limited reliable report of a non-standard 10 day feeding study using citric acid conducted without GLP compliance in mice and rats, identified 10-day NOAEL values in the mouse of 1000 and 4000 g/kg bw/day, (which corresponds to 1590 and 6360 mg tri potassium citrate/kg (bw)/d*)respectively.* Note, the value is derived by using a conversion factor of 1.59 (using MW (tri potassium citrate)/MW (citric acid) = 306/192.9 = 1.59) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dad6dcea-b55f-46dc-aec9-581161b4841e/documents/IUC5-6b45a58d-b108-4bb1-883b-2730d541d61b_87897866-acdb-409f-9f75-1c925d22c82b.html,,,,,, Tripotassium citrate,866-84-2,"The key study for acute oral toxicity was read across from zinc dicitrate, which report an LD50 value of 5400mg/kg (Roche, 1981; rel 2). [PLACEHOLDER FOR DERMAL TOX READ ACROSS]. Data for the acute toxicity inhalation endpoint was waived, since reliable data was available for the acute oral and dermal endpoints. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dad6dcea-b55f-46dc-aec9-581161b4841e/documents/IUC5-1478ec4d-6fd2-4443-8f9f-924c4554baeb_87897866-acdb-409f-9f75-1c925d22c82b.html,,,,,, Tripotassium citrate,866-84-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dad6dcea-b55f-46dc-aec9-581161b4841e/documents/IUC5-1478ec4d-6fd2-4443-8f9f-924c4554baeb_87897866-acdb-409f-9f75-1c925d22c82b.html,,oral,LD50,"5,400 mg/kg bw",, Potassium cyanate,590-28-3,"No state of the art studies after repeated dose exposure via the oral, dermal or inhalation route are available for potassium cyanate. Two studies with i.p. administration are reported. Read across from sodium cyanate was therefore performed in addition. In aqueous solution cyanate salts dissociate very quickly to cyanate ion and the respective alkali metal ion. It is not expected that Na+ or K+ contribute to the repeated dose toxicity of cyanates as both represent basic metal ions present in the human body in high concentrations. Beside a subacute 28-day repeated dose toxicity study, for sodium cyanate only a number of non standard public available literature studies are available. These studies, investigating the repeated dose toxicity in different species (mouse, rat, dog, monkey) for different exposure times (up to one year), together with data from human medical treatment, are summarised in a weight of evidence approach and allow a reliable evaluation of the toxic properties of both sodium and potassium cyanate.A 15 months study with dogs and monkeys showed no effects up to concentrations of 53.5 and 51 mg/kg bw/day respectively. Main adverse effects observed are neurotoxicty and development of cataracts. These effects are considered of secondary nature due to severe changes in the blood system (damage of haemoglobin, disturbance of O2 distribution). Together with several supporting studies, the NOAEL of the chronic study in dogs and monkeys represents a reliable basis as overall NOAEL (oral, long-term) to be used for risk assessment. Human medical treatment causes very similar effects as compared with the dog and monkey data. The effects were noted at about 30 mg/kg bw/day. The NOAEL(dog) of 50 mg/kg bw/day is 1.67 times higher as the NOAEL(human) almost showing the default allometric scaling factor of 1.4. Thus, in conclusion, it is scientifically justified to derive the DNELs long-term from the chronic NOAEL(dog) of 50 mg/kg bw/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): acceptable as weight of evidence approach ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93ffd34c-2d3a-404d-b95b-8b298d68c1cc/documents/4bd853f2-2782-4242-8e95-1ce7556f1db4_0f113ad5-066a-4f2e-bb59-906ba3216570.html,,,,,, Potassium cyanate,590-28-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93ffd34c-2d3a-404d-b95b-8b298d68c1cc/documents/4bd853f2-2782-4242-8e95-1ce7556f1db4_0f113ad5-066a-4f2e-bb59-906ba3216570.html,Chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,dog Potassium cyanate,590-28-3, Oral route The LD50 of potassium cyanate after oral administration to rats was determined to be 567 mg/kg bw for females and 936 mg/kg bw for males. Dermal route The acute dermal LD50 value of the test item potassium cyanate proved to be greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats. Other routes The LD50 of potassium cyanate after i.p. administration to mice was determined to be 320 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93ffd34c-2d3a-404d-b95b-8b298d68c1cc/documents/8aa842f8-01f3-4610-90e6-7d1b2c66b259_0f113ad5-066a-4f2e-bb59-906ba3216570.html,,,,,, Potassium cyanate,590-28-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93ffd34c-2d3a-404d-b95b-8b298d68c1cc/documents/8aa842f8-01f3-4610-90e6-7d1b2c66b259_0f113ad5-066a-4f2e-bb59-906ba3216570.html,,oral,LD50,567 mg/kg bw,adverse effect observed, Potassium cyanate,590-28-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93ffd34c-2d3a-404d-b95b-8b298d68c1cc/documents/8aa842f8-01f3-4610-90e6-7d1b2c66b259_0f113ad5-066a-4f2e-bb59-906ba3216570.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Potassium fluoride,7789-23-3,"Fluoride is not an essential element for humans, but it has been shown that fluoride is beneficial in the prevention of dental caries and also supporting bone strength at moderately high levels. However, effects on the skeletal system have been identified as the key, leading to adverse effects caused by excessive exposure to fluorides, and include reduced bone strength, increase risk of fractures and/or skeletal fluorosis (stiffness of joints, skeletal deformities).Daily intakes below ca. 14 mg F/day can be considered safe for humans, based on a weight-of-evidence approach. To protect the workforce, a workplace exposure limit (=DNEL) has been established at 1 mg F/m³. The DNEL of 1 mg F/m³ is adequately protective, even when considering that workers can - in addition to the inhalation route - be further exposed to fluorides via other routes, i. e. dermal and/or oral (hand-to-mouth-transfer) at the workplace, and also due to a background intake via diet, drinking water and dental care products.In addition to maintaining workplace air concentration below the DNEL of 1 mg F/m³, urine biomonitoring is also recommended to control worker exposure, using the following threshold values:4.0 mg F / g creatinine, when sampled before the work shift, and/or7.0 mg F / g creatinine, when sampled after an exposure period (e.g. end-of-shift). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18808b25-35c5-43a7-b593-d2a547b926b9/documents/IUC5-e3e8a631-69f7-4947-baf5-c1fe66bda8c5_de155022-1cc3-4a43-bacc-30e21dbc8f58.html,,,,,, Potassium fluoride,7789-23-3,"Based on the reported acute oral LD50 values for sodium fluoride in experimental animals, fluoride salts are considered moderately toxic if ingested. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18808b25-35c5-43a7-b593-d2a547b926b9/documents/IUC5-c9f6e35b-7f02-4a0d-9df8-5848d5a960db_de155022-1cc3-4a43-bacc-30e21dbc8f58.html,,,,,, Potassium fluoride,7789-23-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18808b25-35c5-43a7-b593-d2a547b926b9/documents/IUC5-c9f6e35b-7f02-4a0d-9df8-5848d5a960db_de155022-1cc3-4a43-bacc-30e21dbc8f58.html,,oral,LD50,248 mg/kg bw,adverse effect observed, Potassium fluoride,7789-23-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18808b25-35c5-43a7-b593-d2a547b926b9/documents/IUC5-c9f6e35b-7f02-4a0d-9df8-5848d5a960db_de155022-1cc3-4a43-bacc-30e21dbc8f58.html,,dermal,LD50,"3,348 mg/kg bw",no adverse effect observed, Potassium fluoride,7789-23-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18808b25-35c5-43a7-b593-d2a547b926b9/documents/IUC5-c9f6e35b-7f02-4a0d-9df8-5848d5a960db_de155022-1cc3-4a43-bacc-30e21dbc8f58.html,,inhalation,LC50,"1,674 mg/m3",no adverse effect observed, Dipotassium hexafluorosilicate,16871-90-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f7d37f18-ab34-426c-9755-40dedb680437/documents/IUC5-b81f9e6c-ca8e-4796-8b1b-ef7bcfdeaed2_f08522e7-a542-4676-aa31-707044e69405.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,, Dipotassium hexafluorosilicate,16871-90-2,Reliable information on acute inhalation toxicity indicates that the substance shall be classified according to in force regulations. Some non-standard acute oral toxicity studies as well as information on structurally related substance are available and are reported. This data also indicates that the substance shall be classified according to in force regulations. Waivers are appropriate for acute dermal toxicity as it is not a relevant exposure route. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7d37f18-ab34-426c-9755-40dedb680437/documents/IUC5-0e7ffb19-f90c-4bc6-ba77-a78f81aee84a_f08522e7-a542-4676-aa31-707044e69405.html,,,,,, Dipotassium hexafluorosilicate,16871-90-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7d37f18-ab34-426c-9755-40dedb680437/documents/IUC5-0e7ffb19-f90c-4bc6-ba77-a78f81aee84a_f08522e7-a542-4676-aa31-707044e69405.html,,oral,LD50,70 mg/kg bw,, Dipotassium hexafluorosilicate,16871-90-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7d37f18-ab34-426c-9755-40dedb680437/documents/IUC5-0e7ffb19-f90c-4bc6-ba77-a78f81aee84a_f08522e7-a542-4676-aa31-707044e69405.html,,inhalation,LC50,"1,814 mg/m3",, Potassium gluconate,299-27-4,"Sprague Dawley (JCL:SD) rats were administered D-glucono-1,5-lactone (GDL) by oral gavage at daily doses of 0 (vehicle control), 250, 500, 1000, 2000, or 4000 mg/kg body weight for 6 months in a key, repeat-dose toxicity study. This non-GLP study was equivalent to OECD Test Guideline 408 with extended exposure period. A No-Observed-Adverse-Effect Level (NOAEL) was not identified by the authors and one could not be determined as pathological effects in the stomach were observed in all dose-groups. However, these effects were considered local effects and not relevant to humans. Based on a review of the data, the Lowest-Observed-Adverse Effect Level (LOAEL) for local effects was determined to be 250 mg/kg body weight in rats. No systemic toxicity was observed. As GDL hydrolyses to gluconic acid/gluconate, dependent on the pH of the tissue, the results are considered representative to potassium gluconate too. No supporting oral studies were located and no inhalation or dermal repeat-dose toxicity studies have been conducted. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0297019-fb9e-465d-b5cb-f4863b63eac2/documents/a3fdc0ca-fd69-4d2c-8b6b-6c7a1767d2ff_a42e778f-c230-4de8-9e8b-6512473e62bd.html,,,,,, Potassium gluconate,299-27-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0297019-fb9e-465d-b5cb-f4863b63eac2/documents/a3fdc0ca-fd69-4d2c-8b6b-6c7a1767d2ff_a42e778f-c230-4de8-9e8b-6512473e62bd.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,250 mg/kg bw/day,,rat Potassium gluconate,299-27-4,"Potassium gluconate is associated with low acute toxicity in rats following oral administration. The reported oral LD50 of potassium gluconate was 6060 mg/kg body weight in male and female Wistar rats in a study performed to test guidelines (Spanjers and Til, 1978). Transient clinical signs included sluggishness, humpback behaviour, and severe diarrhea and 7 out of 10 animals died at the high dose level of 6.21 g/kg bw between 5 and 21 hours after administration of the test article. There were no macroscopic findings at necropsy. Only 2 out of 10 animals died following application of 5.19 g/kg bw.   Information on the acute dermal effects of potassium gluconate was obtained from data on the read across substance, gluconic acid. Gluconic acid is associated with low acute toxicity following dermal administration in rats. The dermal LD50 value for gluconic acid was determined to be greater than 2000 mg/kg body weight in rats in a study performed according to test guidelines and good laboratory practice (Mortier, 2009). There were no mortalities, adverse clinical effects, body weight effects, dermal reactions, or adverse findings in organ or tissue at necropsy.   In accordance with column 2 of REACH Annex VIII, the acute toxicity by inhalation study (required in section 8.5.2) does not need to be conducted as acute toxicity studies are available for the oral and dermal routes of exposure and as inhalative exposure is unlikely. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0297019-fb9e-465d-b5cb-f4863b63eac2/documents/2da43c54-4cd0-4e78-b37f-7a68d435edff_a42e778f-c230-4de8-9e8b-6512473e62bd.html,,,,,, Potassium gluconate,299-27-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0297019-fb9e-465d-b5cb-f4863b63eac2/documents/2da43c54-4cd0-4e78-b37f-7a68d435edff_a42e778f-c230-4de8-9e8b-6512473e62bd.html,,oral,LD50,"6,060 mg/kg bw",no adverse effect observed, Potassium gluconate,299-27-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0297019-fb9e-465d-b5cb-f4863b63eac2/documents/2da43c54-4cd0-4e78-b37f-7a68d435edff_a42e778f-c230-4de8-9e8b-6512473e62bd.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Potassium hydroxide,1310-58-3,"According to the introductory sections to Annexes VII-X of the REACH Regulation, in vivo testing shall be avoided with corrosive substances at concentrations / dose levels causing corrosivity. Potassium hydroxide is a corrosive substance at concentrations of about 2% and higher. In addition, potassium hydroxide is not expected to be systemically available in the body under normal handling and use conditions and therefore systemic effects of potassium hydroxide after repeated exposure are not expected to occur. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6ac857e-9432-4f17-8a03-ac0f9aa2394b/documents/IUC5-15e1e4e3-a924-4f62-8e78-c0361878fe64_f10cf2bd-e8a3-4188-baff-2ae4d8040a60.html,,,,,, Potassium hydroxide,1310-58-3,"According to the REACH Regulation, acute toxicity testing does not generally need to be conducted if the substance is classified as corrosive to the skin (column 2 adaptation, Annex VIII). Potassium hydroxide is a corrosive substance at concentrations of about 2% and higher. Between 0.5 and 2% it is irritating (OECD SIDS for potassium hydroxide, 2002, p 15). For this reason, there is no need for further acute toxicity testing.In the OECD SIDS (2002, p13) it is also stated that KOH has a moderate acute oral toxicity, which is essentially due to its corrosivity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6ac857e-9432-4f17-8a03-ac0f9aa2394b/documents/IUC5-44cbc29d-3e78-43d3-8e9f-815cb50dcd3b_f10cf2bd-e8a3-4188-baff-2ae4d8040a60.html,,,,,, Potassium hydroxide,1310-58-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6ac857e-9432-4f17-8a03-ac0f9aa2394b/documents/IUC5-44cbc29d-3e78-43d3-8e9f-815cb50dcd3b_f10cf2bd-e8a3-4188-baff-2ae4d8040a60.html,,oral,LD50,333 mg/kg bw,adverse effect observed, Potassium iodide,7681-11-0,"Repeated dose toxicity oral OECD 408 :  Some treatment-related changes were observed during the in vivo phase of the study (slight reductions in body weight, decrease of lymphocytes and triglycerides, increases of cholesterol, blood urea nitrogen and potassium, fluctuations in thyroid hormones levels) and at post mortem observations (liver weight increases, hepatocellular hypertrophy and thyroid gland follicular cell hyperplasia) mainly in males dosed with Potassium Iodide at 100 and/or 300 and 700 mg/kg bw/day. Changes observed during the in vivo phase were not considered to be adverse due to the mild severity and absence of relevant clinical findings. The hepatic hypertrophy was considered an adaptive change, not adverse as the preservation of homeostasis was mantained. Thyroid pathological findings were not considered adverse since the ""escape or adaptation"" phenomenon is poorly understood but it occurs in both rats and normal man (Wolff-Chaikoff effect).Based on these findings, it can be concluded that the No Observed Adverse Effect Level (NOAEL) for this study is 700 mg/kg bw/day.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2817613d-1b20-4da2-9b9a-3966f2c9b57e/documents/292d21d5-460d-41e9-91d4-5a9a2fa76e13_77dda6dc-0275-4955-8482-c4b113e0a689.html,,,,,, Potassium iodide,7681-11-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2817613d-1b20-4da2-9b9a-3966f2c9b57e/documents/292d21d5-460d-41e9-91d4-5a9a2fa76e13_77dda6dc-0275-4955-8482-c4b113e0a689.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,ca.700 mg/kg bw/day,,rat Potassium iodide,7681-11-0,"Acute Toxicity oral OECD 423 :  No abnormalities were observed at necropsy examination performed at the end of the observation period on the survival animals dosed at 2000 mg/kg. The lack of mortality demonstrates the acute toxicity estimate (ATE) to be greater than 2000 mg/kg body weight. European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would indicate the following:Classification : No categorySignal word : No signal word requiredHazard statement : No hazard statement required   Acute Toxicity dermal OECD 402 :  Potassium Iodide, has no toxic effect on the rat following dermal exposure over a 24 hour period at the dose level of 2000 mg/kg. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg. European Directives concerning the classification, packaging and labelling of dangerous substances (Council Regulation (EC) No. 1272/2008 and subsequent revisions) would indicate the following:Classification No categorySignal word No signal word requiredHazard statement No hazard statement required ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2817613d-1b20-4da2-9b9a-3966f2c9b57e/documents/efbe4694-33ec-4b24-abd7-6318227ff897_77dda6dc-0275-4955-8482-c4b113e0a689.html,,,,,, Potassium iodide,7681-11-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2817613d-1b20-4da2-9b9a-3966f2c9b57e/documents/efbe4694-33ec-4b24-abd7-6318227ff897_77dda6dc-0275-4955-8482-c4b113e0a689.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Potassium iodide,7681-11-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2817613d-1b20-4da2-9b9a-3966f2c9b57e/documents/efbe4694-33ec-4b24-abd7-6318227ff897_77dda6dc-0275-4955-8482-c4b113e0a689.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Potassium (S)-lactate,85895-78-9," No data on repeated dose toxicity are available for the target substance potassium-S-lactate itself. Thus, available data from the structurally related substances L-lactide, calcium lactate and potassium chloride were used to assess in a read-across approach the specific toxicity of potassium-S-lactate. In sub-chronic and chronic repeated dose toxicity studies no adverse effects were observed attributable to lactate or potassium. The obtained NOAEL of 1820 mg/kg bw/day from a chronic repeated dose toxicity in rats can be re-calculated on a molar basis to 3130 mg/kg bw/day for the target substance potassium-S-lactate. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a22df25d-6334-4f93-974a-001ced558c7a/documents/IUC5-e7cb3e55-c7e4-4f64-86e2-cf1c210874a4_0a2c2486-d574-4b5b-8c1a-54048543570a.html,,,,,, Potassium (S)-lactate,85895-78-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a22df25d-6334-4f93-974a-001ced558c7a/documents/IUC5-e7cb3e55-c7e4-4f64-86e2-cf1c210874a4_0a2c2486-d574-4b5b-8c1a-54048543570a.html,Chronic toxicity – systemic effects,oral,NOAEL,"3,130 mg/kg bw/day",,rat Potassium (S)-lactate,85895-78-9," By way of read-across from lactic acid, constituting the toxicologically relevant moiety, potassium-S-lactate is evaluated to be acutely non-toxic via any of the standard routes of administration (oral, inhalation, dermal). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a22df25d-6334-4f93-974a-001ced558c7a/documents/IUC5-27a1e9f7-509c-4fb0-920f-61b0516800ce_0a2c2486-d574-4b5b-8c1a-54048543570a.html,,,,,, Potassium dodecyl sulphate,4706-78-9, LD50 was estimated to be 3430 mg/kg bw when Wistar male and female rats were orally exposed with methanetrisulfonic acid.  ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f79c6aa7-d9a9-4c81-852d-17943702c958/documents/41f31d3e-c55a-4e8b-bd2c-900e437c1f60_1b60a4b8-452e-4d57-9576-eb0f18546182.html,,,,,, Potassium dodecyl sulphate,4706-78-9,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f79c6aa7-d9a9-4c81-852d-17943702c958/documents/41f31d3e-c55a-4e8b-bd2c-900e437c1f60_1b60a4b8-452e-4d57-9576-eb0f18546182.html,,oral,LD50,"3,430 mg/kg bw",no adverse effect observed, Dipotassium disulphite,16731-55-8,"A 3-generation chronic toxicity study (Til et al. 1972a) with treatment of rats (20 per sex and group) with dose levels of 0, 0.125, 0.25, 0.5, 1.0 or 2.0% Na2S2O5 administered in a 50 ppm thiamine-containing diet was identified as most reliable study for repeated dose toxicity and was defined as key study (read-across info, see `discussion`). Based on the read across concept for the group of sulfite substances, this result is also applicable to dipotassium disulfite.. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96c4e337-de4f-4d3f-bd0a-8ec7de58076d/documents/IUC5-87b3808a-b2e8-4e0d-acd3-7b549b40f866_71a4420f-8e70-4396-9789-831920c06322.html,,,,,, Dipotassium disulphite,16731-55-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96c4e337-de4f-4d3f-bd0a-8ec7de58076d/documents/IUC5-87b3808a-b2e8-4e0d-acd3-7b549b40f866_71a4420f-8e70-4396-9789-831920c06322.html,Chronic toxicity – systemic effects,oral,NOAEL,126 mg/kg bw/day,,rat Dipotassium disulphite,16731-55-8,"Based on the described read-across methodology information from sodium sulfite (CAS 7757-83-7), sodium metabisulfite (CAS 7681 -57 -4) and substance specific information on potassium metabisulfite (CAS 16731 -55 -8) were used to determine acute toxicity values (oral, dermal and inhalative) for potassium metabisulfite. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96c4e337-de4f-4d3f-bd0a-8ec7de58076d/documents/IUC5-23ba8ae0-a4c8-44a3-b717-7d24a53aca1a_71a4420f-8e70-4396-9789-831920c06322.html,,,,,, Potassium (2S)-4-carboxy-2-(tetradecanoylamino)butanoate,72716-26-8," Oral: LD50 > 2000 mg/kg bw, OECD 423, EU Method B.1 tris, EPA OPPTS 870.1100, Matting (2013). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c2135fd-145e-466f-88da-bd7e310c8e3c/documents/IUC5-1c38036f-e3ee-413e-8caa-7f2d8595aaea_d0c15c05-f1bc-4fea-99da-d86285eff2c4.html,,,,,, Potassium nitrate,7757-79-1,"A reliable 28-day oral OECD 422 study has been performed in rats (5 rats/sex/dose) via gavage, containing 50, 750 or 1500 mg/kg bw/day potassium nitrate. There were no treatment-related deaths and no signs of overt clinical toxicity. There were no effects on body weight, food consumption, or food efficiency. Functional observational battery (FOB) and motor activity tests identified no treatment-related changes in behavior, function, or motor activity. No treatment-related histopathological changes were reported. Therefore, it was concluded that the NOAEL is ≥ 1500 mg KNO3/kg bw/day, ≥920 mg nitrate/kg bw/day (or higher, highest dose tested). A reliable 28 -day oral OECD 407, EU B.7 guideline study has been performed in rats (5 rats/sex/dose) via gavage, containing 50, 150 or 1000 mg/kg bw/day Nitcal-K (potassium pentacalcium nitrate decahydrate). There were no treatment-related deaths and no signs of overt clinical toxicity. There were no effects on body weight, food consumption, or food efficiency. Functional observational battery (FOB) and motor activity tests identified no treatment-related changes in behavior, function, or motor activity. In haematology high-dose males reticulocytes and red cell distribution width were slightly increased; in high-dose females red blood cell count and haematocrit was slightly decreased. Reviewer: these changes are not consistent between males/females, are very slight, and three out of four appeared to be in the historical control range from this strain (based on NOTOX historical data) and this kind of study. Therefore, these are not considered adverse. At gross pathology a thickened limiting ridge and/or foci in glandular mucosa in 2 and 3 high-dose males and females, respectively, were noted. This is a local effect and reversible. At histopathology some non-neoplastic effects were observed: hyperplasia/hyperkeratosis of the limiting ridge of the stomach in 4 and 3 high dose males and females, respectively. This is considered a local effect and reversible according to the reviewer. In addition an increased severity of haemopoietic foci (erythroid) in the spleen at high dose was noted. Reviewer: The effect in the spleen is limited to one male and one female with a moderate severity at the high dose. However, this is a symptom expected in young animals in such a study, in addition it is considered a reversible effect. This is based on expertise of an experienced pathologist. Therefore, it was concluded that the NOAELsystemic is ≥1000 mg Nitcal-K/kg bw/day, ≥56 mg nitrate/kg bw/day(highest dose tested).  In conclusion, no systemic adverse effects were observed up to and including the highest dose tested in two 28-day oral toxicity studies. The data from the 104-week carcinogenicity study in rats (Maekawa et al., 1982) do not indicate adverse toxic effects / carcinogenic potential of sodium nitrate. The Maekawa et al. (1982) study was used by SCF and EFSA for the derivation of the ADI.  F344 rats (50 animals per sex per group, 8 weeks old) were given 0%, 2.5% and 5% sodium nitrate in the diet ad libitum (equivalent to 0, 1250 and 2500 mg/kg bw per day, or 0, 910, or 1820 mg/kg bw per day expressed as nitrate ion) in a 2-year feeding study (Maekawa et al., 1982). Rats in the control group were given a basic diet without nitrate ad libitum. Treatment was stopped at week 104 and the rats were given a basic diet until week 123 to account for the number of survivors in at least one group of either sex that was less than 20%. Diet and water consumption was constant in all groups throughout the study. The growth curves showed that the mean body weight of male fats did not differ more than 10%, whereas female rats differed by more than 10% in the high-dose group after week 60. However, no statistically significant differences were reported for this parameter. Treatment with sodium nitrate did not have statistically significant effect on survival rates, although male rats in the 5% group (equivalent to 2500 mg sodium nitrate/kg bw per day, 1820 mg nitrate ion/kg bw per day) had 10% higher cumulative mortality compared to the 2.5% group (equivalent to 1250 mg sodium nitrate/kg bw per day, 910 mg nitrate ion/kg bw per day). At the end of the study (2 years), both male and female control groups showed a statistically significant lower number of survivors compared to both treatment groups. However, the mean survival time did not differ significantly among all groups. The incidence of tumours in all groups, including controls, was high. For example, the percentage of animals showing tumours in the control groups was reported to reach 94% and 92% for male and female rats, respectively. In male rats from the 2.5% sodium nitrate group (equivalent to 1250 mg/kg bw per day, 910 nitrate ion/kg bw per day), tumour incidence was reported to be 100%, whereas, in male rats from the 5% dose group (equivalent to 2500 mg/kg bw per day, 1820 mg nitrate ion/kg bw per day), the incidence was 96%. All other groups showed lower absolute tumour incidences than controls. The most commonly observed tumour in males was in the testes (interstitial cell) followed by the mammary gland, adrenal gland and liver. Tumours of the mammary gland, pituitary gland, uterus and adrenal gland were the most commonly observed tumours in females. Overall, there was no statistically significant difference of any specific tumour. The time of appearance of the first background tumour was not affected in any treatment group. Only the incidences of tumours of the haematopoietic organs were reported to be statistically significantly lower in the treated groups compared to controls, especially concerning mononuclear cell leukaemia. In conclusion, no adverse effects were observed up to and including the highest dose tested. Sodium nitrate did not have carcinogenic activity in F344 rats when administered continuously for 2 years. In conclusion, no carcinogenic effects were observed and the NOAEL for adverse toxic effects is ≥2500 mg sodium nitrate/kg bw/day, ≥1820 mg nitrate/kg bw/day (highest dose tested). Expert statement: Based on the existing data, read across and current ADI values no relevant toxicity after sub-chronic exposure is expected. Overall, generation of additional sub-chronic oral toxicity data is considered not scientifically justified and the sub-chronic oral toxicity study (90-days) thus waived. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1600c0d1-06fc-44da-aefd-0a03f3c16b83/documents/e091d179-cc37-4f8f-924d-f1e063b890e3_ad9178a0-ce68-4862-bb55-ddca5a11a1f9.html,,,,,, Potassium nitrate,7757-79-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1600c0d1-06fc-44da-aefd-0a03f3c16b83/documents/e091d179-cc37-4f8f-924d-f1e063b890e3_ad9178a0-ce68-4862-bb55-ddca5a11a1f9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,920 mg/kg bw/day,,rat Potassium nitrate,7757-79-1,Based on several studies the oral LD50 is determined to be >2000 mg/kg bw for potassium nitrate. The key study is however performed with potassium sodium nitrate. The read-across rationale can be found in the category approach document attached in the appropriate target endpoint record. An acute inhalation study performed with potassium nitrate according to OECD 403 resulted in an LC50 of >0.527 mg/L air (highest attainable concentration). An acute dermal toxicity study performed with potassium nitrate according to OECD 402 resulted in an LD50 of >5000 mg/kg bw.  ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1600c0d1-06fc-44da-aefd-0a03f3c16b83/documents/71859990-f473-48bf-8552-0d8a0db0dd4d_ad9178a0-ce68-4862-bb55-ddca5a11a1f9.html,,,,,, Potassium nitrate,7757-79-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1600c0d1-06fc-44da-aefd-0a03f3c16b83/documents/71859990-f473-48bf-8552-0d8a0db0dd4d_ad9178a0-ce68-4862-bb55-ddca5a11a1f9.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Potassium nitrate,7757-79-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1600c0d1-06fc-44da-aefd-0a03f3c16b83/documents/71859990-f473-48bf-8552-0d8a0db0dd4d_ad9178a0-ce68-4862-bb55-ddca5a11a1f9.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Potassium nitrate,7757-79-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1600c0d1-06fc-44da-aefd-0a03f3c16b83/documents/71859990-f473-48bf-8552-0d8a0db0dd4d_ad9178a0-ce68-4862-bb55-ddca5a11a1f9.html,,inhalation,LC50,> 527 mg/m3,no adverse effect observed, Dipotassium oxide,12136-45-7,"Oral repeated dose toxicity Potassium chloride (KCl) is the most common source of Potassium oxide (K2O). Therefore, the health effects of potassium chloride need to be considered in the assessment of Potassium oxideGroups of male F344/Slc rats received 110, 450, 1820 mg/kg bw/day of KCl in feed over a period of 2 years and were observed for clinical signs and mortality and were examined for gross and histopathological changes at the end of the treatment period (Imai 1961) The NOAEL was set 1820 mg/kg bw/day since nephritis was reported in all treatment groups as well as in the control group. With respect to the observed gastritis which is regarded to be a local effect a LOAEL(local) of 110 mg/kg bw/d was determined (Imai 1961, UNEP 2003). NOAEL -1820 mg/kg bw/day Dermal repeated dose toxicity There are no dermal repeated studies available. For dermal exposure we taken that: -the average weight of rats is 250g (200-300g), -the dose is applied over an area which is approximately 10% of the total body surface=0.025 kg corrected dermal NOAEL= oral NOAEL 1820 mg/kg bw/day x 0.025 kg = NOAELrat = 45.5 mg/kg bw/day Inhalation repeated dose toxicity There are no Inhalation Repeated studies available. The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m3/kg for 24 hours exposure. The resulting air concentration needs to be additionally corrected for 24 hlight activity (20 m3), assuming 100 % absorption for both routes. NOAEL rat 1820 mg/kg bw/day ÷1.15 m3/kgbw ÷20m3/rat NOAECrat 79.13 mg/m3    ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f766ceb4-7cb3-400c-80a6-0b5747c4b2c8/documents/IUC5-a429c82c-1c9d-4e6b-9ac7-e181046487ba_1e55960e-34ca-4a2f-bd0a-592c94a76eda.html,,,,,, Dipotassium oxide,12136-45-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f766ceb4-7cb3-400c-80a6-0b5747c4b2c8/documents/IUC5-a429c82c-1c9d-4e6b-9ac7-e181046487ba_1e55960e-34ca-4a2f-bd0a-592c94a76eda.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,820 mg/kg bw/day",,rat Dipotassium oxide,12136-45-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f766ceb4-7cb3-400c-80a6-0b5747c4b2c8/documents/IUC5-a429c82c-1c9d-4e6b-9ac7-e181046487ba_1e55960e-34ca-4a2f-bd0a-592c94a76eda.html,Chronic toxicity – systemic effects,dermal,NOAEL,45.5 mg/kg bw/day,,rat Dipotassium oxide,12136-45-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f766ceb4-7cb3-400c-80a6-0b5747c4b2c8/documents/IUC5-a429c82c-1c9d-4e6b-9ac7-e181046487ba_1e55960e-34ca-4a2f-bd0a-592c94a76eda.html,Chronic toxicity – systemic effects,inhalation,NOAEC,79.13 mg/m3,,rat Dipotassium oxide,12136-45-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f766ceb4-7cb3-400c-80a6-0b5747c4b2c8/documents/IUC5-a429c82c-1c9d-4e6b-9ac7-e181046487ba_1e55960e-34ca-4a2f-bd0a-592c94a76eda.html,Repeated dose toxicity – local effects,dermal,NOAEL,5.62 mg/cm2,no adverse effect observed,rat Dipotassium oxide,12136-45-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f766ceb4-7cb3-400c-80a6-0b5747c4b2c8/documents/IUC5-a429c82c-1c9d-4e6b-9ac7-e181046487ba_1e55960e-34ca-4a2f-bd0a-592c94a76eda.html,Repeated dose toxicity – local effects,inhalation,NOAEC,79.13 mg/m3,no adverse effect observed,rat Dipotassium oxide,12136-45-7,"- Acute oral toxicity: The acute oral LD50 in male/female rats is >2000 mg/kg bw. All animals appeared active and healthy throughout the study period. No signs of toxicity were observed.This show that Potassium oxide (the result was read across from Potassium Sodium Nitrate) is not toxic for acute Oral toxicity and Potassium oxide was not classified according to EU or GHS criteria.-Acute Dermal Toxicity: An LD50 value of >5000 mg/kg was obtained for Potassium oxide (the result was read across from Potassium Nitrate). The dermal LD50 in male and female rats is >5000 mg/kg.Alternatively and more conveniently Potassium oxide is synthesized by heating potassium nitrate with metallic potassium.Therefore, the health effects of potassium nitrate need to be considered in the assessment of Potassium oxide.Potassium oxide is not likely to be absorbed through the skin because of the low octanol-water partition coefficient of the substance. A reliable QSAR method predicts a value for the partition co-efficient (logKow) of -5.08 for this substance.This show that Potassium oxide is not toxic for acute Dermal toxicity. Potassium oxide was not classified according to EU or GHS criteria-Acute inhalation toxicity: Dust formation is unlikely because of the hygroscopic properties. Furthermore Potassium oxide has a negligible vapour pressure and therefore dust and vapour exposure are not expected.Potassium oxide was not classified according to EU or GHS criteria. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f766ceb4-7cb3-400c-80a6-0b5747c4b2c8/documents/IUC5-59996b8c-72ed-4391-9a46-e5ca1559a631_1e55960e-34ca-4a2f-bd0a-592c94a76eda.html,,,,,, Dipotassium oxide,12136-45-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f766ceb4-7cb3-400c-80a6-0b5747c4b2c8/documents/IUC5-59996b8c-72ed-4391-9a46-e5ca1559a631_1e55960e-34ca-4a2f-bd0a-592c94a76eda.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dipotassium oxide,12136-45-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f766ceb4-7cb3-400c-80a6-0b5747c4b2c8/documents/IUC5-59996b8c-72ed-4391-9a46-e5ca1559a631_1e55960e-34ca-4a2f-bd0a-592c94a76eda.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Dipotassium oxide,12136-45-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f766ceb4-7cb3-400c-80a6-0b5747c4b2c8/documents/IUC5-59996b8c-72ed-4391-9a46-e5ca1559a631_1e55960e-34ca-4a2f-bd0a-592c94a76eda.html,,inhalation,LC50,86.96 mg/m3,no adverse effect observed, Potassium 5-oxo-L-prolinate,4810-50-8,"As there were no treatment related effects on systemic, reproduction and fertility parameters up to and including the highest dose tested 1000 mg/kg bwt/day, the No Observed Adverse Effect Level (NOAEL) for Combined Repeated Dose Toxicity Study with the  Reproduction/Developmental Toxicity Screening Test by Oral Gavage in Wistar rats for the test item Pidolic Acid is determined to be 1000 mg/kg bwt/day. The repeat dose toxicity of Sodium Pidolate was determined in an oral feeding study which was performed according to a methodology similar to OECD 408. Under the conditions of the study, repeated oral exposure to the test material over a 26 consecutive week period induced no toxic effects in male or female rats. Therefore the NOAEL can be said to be the maximum daily intake, which was determined to be 7200 mg/kg bw/day and 8200 mg/kg bw/day for males and females, respectively. Similar results are expected for potassium pidolate. After oral administration in a combined repeated dose toxicity study with the reproductive toxicity or an oral repeated-dose toxicity study potassium pidolate, just like pidolic acid or sodium pidolate dissociate into Pidolate- and H+/Na+ ions, is expected to dissociate into Pidolate- and K+ ions. H+, Na+ or K+ ions are of little relevance for oral repeated dose toxicity once in solution. Hence pidolic acid, sodium pidolate, and potassium pidolate can be considered toxicologically equivalent with regards to their oral repeated dose toxicity. This is supported by the fact that both, pidolic acid and sodium pidolate, showed no adverse effects in the REACH dossiers studies summarised here with high NOAELs (NOAEL, pidolic acid 1000mg/kg bw/day, NOAEL, sodium pidolate 7200 mg/kg bw/day (male), 8200 mg/kg bw/day (female)). Hence, due to the nature of oral repeated dose toxicity studies, data can be read-across from pidolic acid and/or sodium pidolate. No new studies need to be conducted on potassium pidolate.   A short-term inhalation toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. According to the Column 2 of the Annex VIII of the Regulation (EC) No 1907/2006, testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The mean Vapour Pressure of potassium pidolate is 1.3222mPa at 25°C using 360L of gas flow through the column, therefore a short-term toxicity study via the inhalation route does not need to be conducted. Additionally, a reliable repeated-dose oral toxicity study in rodents according to OECD 408 has been conducted for sodium (2S)-5-oxopyrrolidine-2-carboxylate. Similar results are expected for potassium pidolate, as read-across from sodium (2S)-5-oxopyrrolidine-2-carboxylate to potassium pidolate is possible. Similarly, a short-term dermal toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment.  ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e099bbdc-8e3e-4ea9-abda-773e5847fe06/documents/89684cf5-7962-4280-990a-58df8dda72a4_633eb532-a018-4736-aed5-f92d29623b11.html,,,,,, Potassium 5-oxo-L-prolinate,4810-50-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e099bbdc-8e3e-4ea9-abda-773e5847fe06/documents/89684cf5-7962-4280-990a-58df8dda72a4_633eb532-a018-4736-aed5-f92d29623b11.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Potassium 5-oxo-L-prolinate,4810-50-8,"A study was performed on pidolic acid to assess the acute oral toxicity of the substance in the Wistar strain rat at a dose of 2000 mg/kg bw. There were no deaths. There were no signs of systemic toxicity. All animals showed expected gains in body weight. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the substance in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw. In the acute oral toxicity study once potassium pidolate enters the body (i.e. via oral, inhalation or dermal exposure), similar to the way pidolic acid dissociates into Pidolate- and H+ ions and sodium pidolate into Pidolate- and Na+ ions , potassium pidolate is expected to dissociate into Pidolate- and K+ ions. The H+ and K+ ions are of little relevance for toxicokinetic and toxicology as a whole.  Hence pidolic acid, sodium pidolate, and potassium pidolate can be considered toxicologically equivalent with regards to their acute oral toxicity. This is supported by the fact that both, pidolic acid and sodium pidolate, showed very low acute oral toxicity to vertebrates (LD50s > 2000 mg/kg bw) in the REACH dossiers studies summarised above. Hence, due to the nature of acute oral toxicity studies, data can be read-across from pidolic acid and/or sodium pidolate. No new studies need to be conducted on potassium pidolate.   A study was performed on sodium pidolate to assess the acute oral toxicity of the substance in a study conducted under GLP conditions and in line with OECD 423 and EU Method B. 1 tris, according to the acute toxic class method. Two groups of three females were dosed with the test material, formulated in distilled water, at 2000 mg/kg bw via oral gavage. Animals were observed for 14 days post treatment for mortality, clinical signs of toxicity, changes in body weight and macroscopic changes at necropsy. Under the conditions of the study, no mortalities or signs of toxicity were observed in treated animals. The LD50 was therefore considered to be greater than 2000 mg/kg bw. This supports the findings above for pidolic acid. Similar results are expected for potassium pidolate.   A study was performed to assess the acute inhalation toxicity of Pidolic acid in the Wistar strain rat. A troup of ten rates (five males and five females) were exposed to a dust atmosphere (5mg/L) of the test item for 4 hours using a nose only exposure system, followed by a 14 or 35 days observation period. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths. The acute inhalation median lethal concentration (LC50) of the test item in the Wistar strain rat was estimated to be greater than 5.00 mg/L. Similar results are expected for potassium pidolate. After inhalation in an acute inhalation toxicity study potassium pidolate, just like pidolic acid which is expected to dissociate into Pidolate-  and H+ ions, will dissociate into  Pidolate- and K+ ions. H+ and K+ ions are of little relevance for acute inhalation toxicity once in solution. Hence pidolic acid and potassium pidolate can be considered toxicologically equivalent with regards to their acute inhalation toxicity.  Hence, due to the nature of acute inhalation toxicity studies, data can be read-across from pidolic acid. No new studies need to be conducted on potassium pidolate.   In terms of an acute dermal toxicity study, the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation) for pidolic acid (which can be used for read-across to potassium pidolate as explained above).  ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e099bbdc-8e3e-4ea9-abda-773e5847fe06/documents/b57f92d4-e0dd-410e-b0ad-8446d28d093e_633eb532-a018-4736-aed5-f92d29623b11.html,,,,,, Potassium 5-oxo-L-prolinate,4810-50-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e099bbdc-8e3e-4ea9-abda-773e5847fe06/documents/b57f92d4-e0dd-410e-b0ad-8446d28d093e_633eb532-a018-4736-aed5-f92d29623b11.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dipotassium peroxodisulphate,7727-21-1," Dipotassium persulfate was tested for repeated dose toxicity in rats in a 28-day study. A NOAEL value of 131.5 was determined. Additional repeated dose toxicity studies were available for substances of the Persulfate Category. For disodium persulfate and diammonium persulfate a NOAEL of 91 mg/kg bw/day for subchronic oral toxicity and a NOAEC of 10.3 mg/m³ for subchronic inhalation toxicity, respectively, were determined. Repeated dose toxicity via the dermal route was waived. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64d481c1-4ff4-4832-a53b-e7c12660fa7a/documents/61f6de83-e443-4b0a-ba87-fbb498444f05_c72a359e-3d35-40e8-9404-fff2d71c3729.html,,,,,, Dipotassium peroxodisulphate,7727-21-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64d481c1-4ff4-4832-a53b-e7c12660fa7a/documents/61f6de83-e443-4b0a-ba87-fbb498444f05_c72a359e-3d35-40e8-9404-fff2d71c3729.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,91 mg/kg bw/day,,rat Dipotassium peroxodisulphate,7727-21-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64d481c1-4ff4-4832-a53b-e7c12660fa7a/documents/61f6de83-e443-4b0a-ba87-fbb498444f05_c72a359e-3d35-40e8-9404-fff2d71c3729.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,10.3 mg/m3,,rat Dipotassium peroxodisulphate,7727-21-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64d481c1-4ff4-4832-a53b-e7c12660fa7a/documents/61f6de83-e443-4b0a-ba87-fbb498444f05_c72a359e-3d35-40e8-9404-fff2d71c3729.html,Repeated dose toxicity – local effects,inhalation,NOAEC,10.3 mg/m3,adverse effect observed,rat Dipotassium peroxodisulphate,7727-21-1," Dipotassium persulfate was tested for acute toxicity via the oral, dermal and inhalation routes. In an acute oral toxicity study a LD50 value of 1130 mg/kg bw was determined. In an acute dermal toxicity study LD50 and LD0 values of greater than 10000 mg/kg bw and 10000 mg/kg bw, respectively, were determined. In an acute inhalation toxicity study LC50 and LC0 values of greater than 42.9 mg/L and 42.9 mg/L, respectively, were revealed. Additional studies were available for substances of the Persulfate Category, diammonium persulfate and disodium persulfate. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64d481c1-4ff4-4832-a53b-e7c12660fa7a/documents/8c73d3d6-9516-46b1-8333-8cb06b4b9dcf_c72a359e-3d35-40e8-9404-fff2d71c3729.html,,,,,, Dipotassium peroxodisulphate,7727-21-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64d481c1-4ff4-4832-a53b-e7c12660fa7a/documents/8c73d3d6-9516-46b1-8333-8cb06b4b9dcf_c72a359e-3d35-40e8-9404-fff2d71c3729.html,,oral,LD50,"1,130 mg/kg bw",adverse effect observed, Dipotassium peroxodisulphate,7727-21-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64d481c1-4ff4-4832-a53b-e7c12660fa7a/documents/8c73d3d6-9516-46b1-8333-8cb06b4b9dcf_c72a359e-3d35-40e8-9404-fff2d71c3729.html,,dermal,LD50,"10,000 mg/kg bw",no adverse effect observed, Dipotassium peroxodisulphate,7727-21-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64d481c1-4ff4-4832-a53b-e7c12660fa7a/documents/8c73d3d6-9516-46b1-8333-8cb06b4b9dcf_c72a359e-3d35-40e8-9404-fff2d71c3729.html,,inhalation,LC50,"42,900 mg/m3",no adverse effect observed, Potassium dihydrogenorthophosphate,7778-77-0,"The key information has been provided on the analogous substance sodium aluminium phosphate. The key study (Matalski K, 1972b) has been selected as the most reliable or appropriate study for use in the derivation of DNELS. In addition a reliable 28 day study (OECD 422) exists for the analogous substance dipotassium hydrogenorthophosphate (Shim, 2005), however as the study is only a 28-day study and in accordance with Annex XI, Section 3.2 (a.ii) of Regulation (EC) N0. 1907/2006 (REACH) the data are not considered to be suitable for derivation of a DNEL as subchronic data are available. Additional supporting data provided on potassium dihydrogenorthophosphate are not considered to fulfil the guideline requirements for repeated dose toxicity (sub-chronic or chronic). Full justification for the choice of data and the rationale for read-across can be found below. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/046d83b7-31f2-4347-bdf1-0aea02a804aa/documents/IUC5-05e70578-b2b0-4e48-bb9f-71ce39bbb5c2_8607bb20-7df9-4313-b787-b94f49293328.html,,,,,, Potassium dihydrogenorthophosphate,7778-77-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/046d83b7-31f2-4347-bdf1-0aea02a804aa/documents/IUC5-05e70578-b2b0-4e48-bb9f-71ce39bbb5c2_8607bb20-7df9-4313-b787-b94f49293328.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,322.88 mg/kg bw/day,,dog Potassium dihydrogenorthophosphate,7778-77-0," Acute oral toxicity: Two studies are available to assess the acute oral toxicity of potassium dihydrogenorthophosphate. Both studies indicate that potassium dihydrogenorthophosphate has a low potential for systemic toxicity following acute administration via the oral route. A weight of evidence approach has been implemented to reduce unnecessary animal testing. The LD50 of potassium dihydrogenorthophosphate is known to be > 2,000 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP).  Acute inhalation toxicity: One key study is available to assess the acute inhalation toxicity of the analogous substance sodium dihydrogenorthophosphate. The key study (Signorin J, 1993) has been conducted according to the relevant guidelines (EU and US) and according to the principles of GLP. The acute inhalation median concentration (LC50) in male and female rats was estimated to be > 0.83 mg/L (the maximum attainable concentration). It is therefore anticipated that potassium dihydrogenorthophosphate is of equally low concern via the inhalation route. Acute dermal toxicity: One key study and a number of supporting studies are provided. All studies support no classification. The key study (Moore, 2006) details the acute dermal toxicity of the analogue substance potassium pentahydrogen bis(phosphate) which has an LD50 of >2,000 mg /kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP). This classification can be read across to potassium dihydrogenorthophosphate on the basis of the argumentation provided below. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/046d83b7-31f2-4347-bdf1-0aea02a804aa/documents/IUC5-6a1783b6-9429-41f2-b6f1-f94d486f898e_8607bb20-7df9-4313-b787-b94f49293328.html,,,,,, Potassium propionate,327-62-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85783c5c-c2af-4b8c-b83d-776f062bd365/documents/ab081924-4afb-4f1b-b5ce-1edaef92cc91_db6d6208-ec4b-4708-8663-cf29db79b6e0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,200 mg/kg bw/day",,rat Potassium propionate,327-62-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85783c5c-c2af-4b8c-b83d-776f062bd365/documents/a3fdc19e-15aa-4146-8c34-f0ff3f503136_db6d6208-ec4b-4708-8663-cf29db79b6e0.html,,oral,LD50,"> 2,200 mg/kg bw",no adverse effect observed, Potassium salicylate,578-36-9," The acute oral toxicity profile of sodium salicylate (CAS No. 54-21-7) was studied in female wistar albino rats according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).The lethal concentration (LD50) cut-off value for acute oral toxicity test was considered to be 500 mg/kg bw. Based on structural similarity, the study result of sodium salicylate was used when evaluating the acute toxicity of potassium salicylate. Consequently, Potassium salicylate was classified as Harmful if swallowed (Acute tox. 4). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ffec3030-9aa0-4bcb-9555-e4415811ad7b/documents/5827f483-3057-4c57-bb0c-b6192b8302db_25a5d213-3005-42d8-b62f-3891f0607fa5.html,,,,,, Potassium salicylate,578-36-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ffec3030-9aa0-4bcb-9555-e4415811ad7b/documents/5827f483-3057-4c57-bb0c-b6192b8302db_25a5d213-3005-42d8-b62f-3891f0607fa5.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "Silicic acid, potassium salt",1312-76-1,NOAEL (rats) = 159 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2363ccaf-2014-4b6c-8bcb-602d4a9088a8/documents/ddfb8bf9-2764-45b9-b41c-11b5bf7b4e15_861415b7-873f-41cb-aad0-0f112c5ac6cd.html,,,,,, "Silicic acid, potassium salt",1312-76-1,"oral: LD50 (rat, female) > 5000 mg/kg bwinhalation: LC50 (rat) > 2.06 g/m3dermal: LD50 (rat) > 5000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2363ccaf-2014-4b6c-8bcb-602d4a9088a8/documents/3dc8f1d9-8baf-457d-a5ac-33d2f6089e0f_861415b7-873f-41cb-aad0-0f112c5ac6cd.html,,,,,, Potassium sodium tartrate,304-59-6,Tartaric acid and its salts do not have significant (sub)chronic toxicity. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0dd043bb-2057-488c-aa64-633942b9c3c3/documents/2a8c1329-dfda-44d6-9ceb-0698a75276c1_04354991-c5b5-44fa-b103-f59b278d48a0.html,,,,,, Potassium sodium tartrate,304-59-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0dd043bb-2057-488c-aa64-633942b9c3c3/documents/2a8c1329-dfda-44d6-9ceb-0698a75276c1_04354991-c5b5-44fa-b103-f59b278d48a0.html,Chronic toxicity – systemic effects,oral,NOAEL,"2,460 mg/kg bw/day",,rat Potassium sodium tartrate,304-59-6,Tartaric acid and its salts does not have significant acute toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0dd043bb-2057-488c-aa64-633942b9c3c3/documents/d04fce80-e023-401f-9296-ffc13b985da3_04354991-c5b5-44fa-b103-f59b278d48a0.html,,,,,, Potassium sodium tartrate,304-59-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0dd043bb-2057-488c-aa64-633942b9c3c3/documents/d04fce80-e023-401f-9296-ffc13b985da3_04354991-c5b5-44fa-b103-f59b278d48a0.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Potassium (E,E)-hexa-2,4-dienoate",24634-61-5,"In short-term to subchronic oral studies, Sorbic Acid and Potassium Sorbate were pratically non-toxic in rats and dogs at concentrations up to 10 and 2% respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79a0fbfc-6ea9-47f3-9baf-365882578608/documents/IUC5-9fcafd98-87a3-49f3-947e-1105b3cf1d02_3d276238-a7be-479e-a515-e69e33803b45.html,,,,,, "Potassium (E,E)-hexa-2,4-dienoate",24634-61-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79a0fbfc-6ea9-47f3-9baf-365882578608/documents/IUC5-9fcafd98-87a3-49f3-947e-1105b3cf1d02_3d276238-a7be-479e-a515-e69e33803b45.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"6,792 mg/kg bw/day",,rat "Potassium (E,E)-hexa-2,4-dienoate",24634-61-5,"Acute toxicity testing by any route (oral, inhalation, and dermal) demonstrate no evidence of toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79a0fbfc-6ea9-47f3-9baf-365882578608/documents/IUC5-8f44019a-53b9-419a-8cc4-e558355bf294_3d276238-a7be-479e-a515-e69e33803b45.html,,,,,, "Potassium (E,E)-hexa-2,4-dienoate",24634-61-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79a0fbfc-6ea9-47f3-9baf-365882578608/documents/IUC5-8f44019a-53b9-419a-8cc4-e558355bf294_3d276238-a7be-479e-a515-e69e33803b45.html,,oral,LD50,"10,500 mg/kg bw",, "Potassium (E,E)-hexa-2,4-dienoate",24634-61-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79a0fbfc-6ea9-47f3-9baf-365882578608/documents/IUC5-8f44019a-53b9-419a-8cc4-e558355bf294_3d276238-a7be-479e-a515-e69e33803b45.html,,dermal,LD50,"2,000 mg/kg bw",, Potassium sulfate,7778-80-5,"A reliable subacute oral toxicity study available on potasium sulphate shows a NOAEL of 1500 mg/kg bw/day, the highest dose tested. The study was performed according to OECD 422. In addition, repeated dose toxicity data on ammonium sulphate are considered. The 90-day oral study in rats showing a NOAEL of 886 mg/kg bw/day (LOAEL 1792 mg/kg bw/day) and the chronic oral toxicity study in rats showing a NOAEL of 256 mg/kg bw/day (LOAEL 1527 mg/kg bw/day). Based on these reliable studies with potassium sulphate and ammonium sulphate for oral repeated dose toxicity, the rat oral NOAEL for the sulphate category is 1500 mg/kg bw/day for subacute toxicity. For chronic toxicity the NOAEL for the sulphate category is 256 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc58b977-c338-4d99-98e4-8dda9890ad23/documents/IUC5-41b25225-9025-4cfe-9632-c70512ac19da_82f6291c-2010-4cae-b6f9-bbc81bf680dc.html,,,,,, Potassium sulfate,7778-80-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc58b977-c338-4d99-98e4-8dda9890ad23/documents/IUC5-41b25225-9025-4cfe-9632-c70512ac19da_82f6291c-2010-4cae-b6f9-bbc81bf680dc.html,Chronic toxicity – systemic effects,oral,NOAEL,256 mg/kg bw/day,,rat Potassium sulfate,7778-80-5,"With potassium sulphate a reliable acute dermal toxicity study in rats (according to OECD 402) has been performed showing an LD50 > 2000 mg/kgbw. A reliable acute oral toxicity study with rats according to OECD 425 with potassium magnesium sulphate has been performed, showing LD50>2000 mg/kg bw. An inhalation study with ammonium sulphate investigating mucociliary clearance did not show effects in rats at 3.6 mg/m3.Based on reliable studies on potassium magnesium sulphate and ammonium sulphate for acute oral route, the LD50 for the sulphate category is >2000 mg/kg. Based on a reliable acute inhalation study on ammonium sulphate, the LC50 for the sulphate category is >1200 mg/m3. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc58b977-c338-4d99-98e4-8dda9890ad23/documents/IUC5-03c673b3-0687-4e66-a9bb-9bb608573c44_82f6291c-2010-4cae-b6f9-bbc81bf680dc.html,,,,,, Potassium sulfate,7778-80-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc58b977-c338-4d99-98e4-8dda9890ad23/documents/IUC5-03c673b3-0687-4e66-a9bb-9bb608573c44_82f6291c-2010-4cae-b6f9-bbc81bf680dc.html,,oral,LD50,"2,000 mg/kg bw",, Potassium sulfate,7778-80-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc58b977-c338-4d99-98e4-8dda9890ad23/documents/IUC5-03c673b3-0687-4e66-a9bb-9bb608573c44_82f6291c-2010-4cae-b6f9-bbc81bf680dc.html,,dermal,LD50,"2,000 mg/kg bw",, Potassium sulfate,7778-80-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc58b977-c338-4d99-98e4-8dda9890ad23/documents/IUC5-03c673b3-0687-4e66-a9bb-9bb608573c44_82f6291c-2010-4cae-b6f9-bbc81bf680dc.html,,inhalation,LC50,"1,200 mg/m3",, Potassium sulphite,10117-38-1,"A 3-generation chronic toxicity study (Til et al. 1972a) with treatment of rats (20 per sex and group) with dose levels of 0, 0.125, 0.25, 0.5, 1.0 or 2.0% Na2S2O5 administered in a 50 ppm thiamine-containing diet was identified as most reliable study for repeated dose toxicity and was defined as key study (read-across info, see `discussion`). Based on the read across concept for the group of sulfite substances, this result is also applicable to potassium sulfite. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5987869a-9f58-4b4e-b95f-ca7d602d9859/documents/IUC5-3e568cca-9350-4295-a379-4b86b3ab53b2_b882034f-3735-4fbe-b390-9b0ea1748d14.html,,,,,, Potassium sulphite,10117-38-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5987869a-9f58-4b4e-b95f-ca7d602d9859/documents/IUC5-3e568cca-9350-4295-a379-4b86b3ab53b2_b882034f-3735-4fbe-b390-9b0ea1748d14.html,Chronic toxicity – systemic effects,oral,NOAEL,180 mg/kg bw/day,,rat Potassium sulphite,10117-38-1,"Based on the described read-across methodology information from sodium sulfite (CAS 7757-83-7), sodium metabisulfite (CAS 7681 -57 -4) and potassium metabisulfite (CAS 16731 -55 -8) were used to determine acute toxicity values (oral, dermal and inhalative) for potassium sulfite.Please see `discussion` below. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5987869a-9f58-4b4e-b95f-ca7d602d9859/documents/IUC5-e39f2ec9-4340-46a0-a454-6283f23a74a1_b882034f-3735-4fbe-b390-9b0ea1748d14.html,,,,,, Potassium 3-sulphonatopropyl acrylate,31098-20-1," Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD 422), rat: NOAEL ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8e1238c-a4fd-4506-aac9-fe01ec0b053f/documents/IUC5-db85103e-53fe-4cde-9331-f9c21318baff_8c07cc65-e033-49bf-ab7b-2f2b55eb33b7.html,,,,,, Potassium 3-sulphonatopropyl acrylate,31098-20-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8e1238c-a4fd-4506-aac9-fe01ec0b053f/documents/IUC5-db85103e-53fe-4cde-9331-f9c21318baff_8c07cc65-e033-49bf-ab7b-2f2b55eb33b7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Potassium 3-sulphonatopropyl acrylate,31098-20-1," Oral (OECD 423), rat: LD50 = 5000 mg/kg bw (limit test) Dermal (OECD 403), rat: LD50 > 2000 mg/kg bw (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8e1238c-a4fd-4506-aac9-fe01ec0b053f/documents/IUC5-6f06e2b7-051b-4b6b-8824-659dbf3504b8_8c07cc65-e033-49bf-ab7b-2f2b55eb33b7.html,,,,,, Potassium 3-sulphonatopropyl acrylate,31098-20-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8e1238c-a4fd-4506-aac9-fe01ec0b053f/documents/IUC5-6f06e2b7-051b-4b6b-8824-659dbf3504b8_8c07cc65-e033-49bf-ab7b-2f2b55eb33b7.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Potassium 3-sulphonatopropyl acrylate,31098-20-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8e1238c-a4fd-4506-aac9-fe01ec0b053f/documents/IUC5-6f06e2b7-051b-4b6b-8824-659dbf3504b8_8c07cc65-e033-49bf-ab7b-2f2b55eb33b7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dipotassium tartrate,921-53-9,Tartaric acid and its salts do not have significant (sub)chronic toxicity. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b051ee0-602e-483f-b84c-f0a3de01e920/documents/2a8c1329-dfda-44d6-9ceb-0698a75276c1_99c09006-f754-4bd7-9947-25c2e9c3bd29.html,,,,,, Dipotassium tartrate,921-53-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b051ee0-602e-483f-b84c-f0a3de01e920/documents/2a8c1329-dfda-44d6-9ceb-0698a75276c1_99c09006-f754-4bd7-9947-25c2e9c3bd29.html,Chronic toxicity – systemic effects,oral,NOAEL,"2,460 mg/kg bw/day",,rat Dipotassium tartrate,921-53-9,Tartaric acid and its salts does not have significant acute toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b051ee0-602e-483f-b84c-f0a3de01e920/documents/d04fce80-e023-401f-9296-ffc13b985da3_99c09006-f754-4bd7-9947-25c2e9c3bd29.html,,,,,, Dipotassium tartrate,921-53-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b051ee0-602e-483f-b84c-f0a3de01e920/documents/d04fce80-e023-401f-9296-ffc13b985da3_99c09006-f754-4bd7-9947-25c2e9c3bd29.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Potassium thiocyanate,333-20-0,"There are no acceptable studies available with Potassium thiocyanate. There is one acceptable study report available in rats that was performed with ammonium thiocyanate according to OECD408 and GLP.In this 90-day study in rats mortality was observed after daily exposure to ammonium thiocyanate at a level of 500 mg/kg bw per day. At 500 and 100 mg/kg bw signs of toxicity include changes in haematological and clinical chemistry parameters. Based on these effects, the NOAEL for 90 day exposure is 20 mg NH4SCN/kg bw/day, which is equal to 25.5 mg KSCN/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b5e0e44-6ddd-4ec3-8083-880118458aa0/documents/IUC5-a3b6dba5-62a4-4cd9-8efd-dc18e8a2616b_c0e693af-c320-49f4-b8f9-3335261e4a21.html,,,,,, Potassium thiocyanate,333-20-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b5e0e44-6ddd-4ec3-8083-880118458aa0/documents/IUC5-a3b6dba5-62a4-4cd9-8efd-dc18e8a2616b_c0e693af-c320-49f4-b8f9-3335261e4a21.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25.5 mg/kg bw/day,,rat Potassium thiocyanate,333-20-0,"The key value from acute oral toxicity is derived from a study with ammonium thiocyanate in Japanese quails (OECD 401, GLP) resulting to a LD50 508 mg/kg bw, which equals to 649 mg/kg bw when based on KSCN.In an acute dermal toxicity study with potassium thiocyanate no mortalities occurred and the LD50 is >2000 mg/kg bw.An acute inhalation study is not available but inhalation is not a likely route of exposure due to the low vapour pressure, hygroscopic properties of the substance and the way of use. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b5e0e44-6ddd-4ec3-8083-880118458aa0/documents/IUC5-b930b450-67b9-4a69-b7c8-e42064bbc554_c0e693af-c320-49f4-b8f9-3335261e4a21.html,,,,,, Potassium thiocyanate,333-20-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b5e0e44-6ddd-4ec3-8083-880118458aa0/documents/IUC5-b930b450-67b9-4a69-b7c8-e42064bbc554_c0e693af-c320-49f4-b8f9-3335261e4a21.html,,oral,LD50,649 mg/kg bw,adverse effect observed, Potassium thiocyanate,333-20-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b5e0e44-6ddd-4ec3-8083-880118458aa0/documents/IUC5-b930b450-67b9-4a69-b7c8-e42064bbc554_c0e693af-c320-49f4-b8f9-3335261e4a21.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Potassium mercaptoacetate,34452-51-2,"No reliable data is available on the repeated dose toxicity of potassium thioglycolate. However, the subchronic toxicity of sodium thioglycolate was evaluated by oral and dermal administrations. In an oral repeated dose toxicity study (OECD 408), sodium mercaptoacetate was administered by gavage, 7 days/week, for 13 weeks, to male and female Sprague-Dawley rats. Sporadic mortality and fully reversible effects on some haematological and biochemical parameters and histopathological changes in liver were observed at 60 mg/kg bw/d. These effects may be related to the inhibition of the β-oxidation of fatty acids a known mechanism of action of sodium mercaptoacetate. Consequently, based on the effects observed at 60 mg a. i. /kg/day, particularly mortality, hematological and significant blood chemistry changes associated with liver microscopic changes and the limited blood chemistry effects without microscopic adverse changes in the liver observed at 20 mg a. i. /kg/day, the NOAEL of sodium mercaptoacetate was 20 mg a. i. /kg/day, and the NOEL was 7 mg a. i. /kg/day given by daily oral administration (gavage) to rats for 13 weeks. Additional information on the oral repeated dose toxicity of sodium mercaptoacetate is provided by the 2-generation reprotoxicity study (OECD 416) study and the reproduction/developmental screening test (OECD 421). The results of both studies support the NOAEL 20 mg a. i. /kg/day defined in the 13-week toxicity study. In a repeated dose dermal toxicity (OECD 411), sodium mercaptoacetate was administered via dermal route, 5 days per week, for 13 weeks to male and female Fischer 344 rats and B6C3F1 mice. All animals survived the 13 weeks administration. The only treatment related effect was skin irritation at the site of application. The LOELs for skin irritation were 11.25 and 45 mg/kg bw/d and the NOAELs for systemic toxicity were higher than 180 and 360 mg/kg bw/d in rats and mice, respectively. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): adequate and valid ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6a28689-ee3a-48bb-bba3-c257b8a065a2/documents/36f56ece-ea0a-43e1-8ee2-dc8a7433c7b3_6d0298fb-4613-4a8a-b422-a6fd0c4cb577.html,,,,,, Potassium mercaptoacetate,34452-51-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6a28689-ee3a-48bb-bba3-c257b8a065a2/documents/36f56ece-ea0a-43e1-8ee2-dc8a7433c7b3_6d0298fb-4613-4a8a-b422-a6fd0c4cb577.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,23 mg/kg bw/day,,rat Potassium mercaptoacetate,34452-51-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6a28689-ee3a-48bb-bba3-c257b8a065a2/documents/36f56ece-ea0a-43e1-8ee2-dc8a7433c7b3_6d0298fb-4613-4a8a-b422-a6fd0c4cb577.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,205 mg/kg bw/day,,rat Potassium mercaptoacetate,34452-51-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6a28689-ee3a-48bb-bba3-c257b8a065a2/documents/36f56ece-ea0a-43e1-8ee2-dc8a7433c7b3_6d0298fb-4613-4a8a-b422-a6fd0c4cb577.html,Repeated dose toxicity – local effects,dermal,LOAEL,63 ,adverse effect observed, Potassium mercaptoacetate,34452-51-2, KTG is toxic by ingestion (Acute Tox 3). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6a28689-ee3a-48bb-bba3-c257b8a065a2/documents/af72294b-f5b9-4922-a6bb-a2a9282b612c_6d0298fb-4613-4a8a-b422-a6fd0c4cb577.html,,,,,, Potassium mercaptoacetate,34452-51-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6a28689-ee3a-48bb-bba3-c257b8a065a2/documents/af72294b-f5b9-4922-a6bb-a2a9282b612c_6d0298fb-4613-4a8a-b422-a6fd0c4cb577.html,,oral,LD50,200 mg/kg bw,adverse effect observed, Potassium mercaptoacetate,34452-51-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6a28689-ee3a-48bb-bba3-c257b8a065a2/documents/af72294b-f5b9-4922-a6bb-a2a9282b612c_6d0298fb-4613-4a8a-b422-a6fd0c4cb577.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "Glycerol, propoxylated",25791-96-2,"NOAEL (28 days repeated dose, Wistar): ≥ 1000 mg/kg bw. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fecd6096-7aec-450b-8bf7-6ccd5a8a2216/documents/IUC5-5b69b3f8-7264-4601-9815-be5ce34288f7_ee6d7561-ad31-4f7c-bccd-3d6c69b596df.html,,,,,, "Glycerol, propoxylated",25791-96-2,Acute toxicity via oral route LD50 was determined as >2000 mg/kg bw as per OECD guideline 401 and >2500 mg/kg bw as per OECD 423. The acute toxicity via dermal route was determined as >2000 mg/kg bw as per OECD guideline 402. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fecd6096-7aec-450b-8bf7-6ccd5a8a2216/documents/IUC5-57c927da-fda4-48c7-9a11-dddfbd07a76d_ee6d7561-ad31-4f7c-bccd-3d6c69b596df.html,,,,,, "Propane-1,2-diol, propoxylated",25322-69-4,"NOAEL (28 days repeated dose, Wistar): = 1000 mg/kg bw. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8abdc2ab-3a45-4cf0-8f45-066f9047e087/documents/IUC5-f31cc7ef-cd8c-441b-96ba-fc8bedbcf454_e031a202-34b4-463d-917e-695fd869f7ca.html,,,,,, "Propane-1,2-diol, propoxylated",25322-69-4,"Acute toxicity of MPG, propoxylated via oral route were determined to be >2000 and >5000 mg/kg body weight in two studies and in the dermal study was determined to be >3000 mg/kg body weight.Tetrapropylene Glycol, a major component of PPG, has been tested for acute oral and dermal toxicity in male rats. Although the tests were not conducted according to a guideline or GLPs, adequate information was available to determine that the tests and resulting data were reliable. There was no mortality for either test. The estimated values for acute oral LD50 and dermal LD50 for Tetrapropylene Glycol in rats are >2000 mg/kg bw. Tetrapropylene Glycol Crude (also known as Tripropylene Glycol Bottoms), representative of PPG/PG Highers composition with significant proportion of tetrapropylene glycol and tripropylene glycol, has been tested for acute oral toxicity and acute inhalation toxicity in male rats, and for acute dermal toxicity in female rabbits. Although these tests were not conducted according to a guideline or GLPs, adequate information was available to determine that these tests and the resulting data are reliable. There was no mortality for either the oral or the dermal test. The estimated values for acute oral LD50 and acute dermal LD50 for Tetrapropylene Glycol Crude (Tripropylene Glycol Bottoms) in rats are >2000 mg/kg bw.The acute inhalation toxicity of Tetrapropylene Glycol Crude (Tripropylene Glycol Bottoms) in rats was evaluated with a 1-h exposure (whole body); there was no mortality in the 2-week observation period. The acute inhalation LD50 (1-h) is >0.17 mg/L, which was calculated based on weight of test material. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8abdc2ab-3a45-4cf0-8f45-066f9047e087/documents/IUC5-b90a90a8-e095-4c5e-aff9-9ccbb9141f71_e031a202-34b4-463d-917e-695fd869f7ca.html,,,,,, "Poly[oxy(methyl-1,2-ethanediyl)],α-butyl-ω-hydroxy-",9003-13-8,A GLP-study according to OECD guideline 422 is available for TPnB-highers. In addition a 90-day drinking water study in rats - conducted according to GLP and OECD guideline 408 - is available for the structural analogue TPnB. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c98e3f8-61fb-469e-8e1a-c7d1c5617bf6/documents/IUC5-6f18fdce-c1fd-40a3-968e-058f8008e26b_a55eeec9-9c75-4525-b067-d8a84f64b9d1.html,,,,,, "Poly[oxy(methyl-1,2-ethanediyl)],α-butyl-ω-hydroxy-",9003-13-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c98e3f8-61fb-469e-8e1a-c7d1c5617bf6/documents/IUC5-6f18fdce-c1fd-40a3-968e-058f8008e26b_a55eeec9-9c75-4525-b067-d8a84f64b9d1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,, "Poly[oxy(methyl-1,2-ethanediyl)],α-butyl-ω-hydroxy-",9003-13-8,GLP-studies according to OECD guidelines 423 and 402 are available for tripropylene glycol butyl ether highers (TPnB-H). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c98e3f8-61fb-469e-8e1a-c7d1c5617bf6/documents/IUC5-f7882638-c7a1-47b3-8ee0-8db24b209d48_a55eeec9-9c75-4525-b067-d8a84f64b9d1.html,,,,,, "Poly[oxy(methyl-1,2-ethanediyl)],α-butyl-ω-hydroxy-",9003-13-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c98e3f8-61fb-469e-8e1a-c7d1c5617bf6/documents/IUC5-f7882638-c7a1-47b3-8ee0-8db24b209d48_a55eeec9-9c75-4525-b067-d8a84f64b9d1.html,,oral,LD50,300 mg/kg bw,, "Poly[oxy(methyl-1,2-ethanediyl)],α-butyl-ω-hydroxy-",9003-13-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c98e3f8-61fb-469e-8e1a-c7d1c5617bf6/documents/IUC5-f7882638-c7a1-47b3-8ee0-8db24b209d48_a55eeec9-9c75-4525-b067-d8a84f64b9d1.html,,dermal,LD50,"2,000 mg/kg bw",, (2-methoxymethylethoxy)propanol,34590-94-8,"For the oral route, a 28-day oral gavage study conducted under GLP and according to guideline (KANPOGYO No.700, YAKUHATSU No. 1039.61, and KIKYKU No. 1014) is available for dipropylene glycol methyl ether. For the dermal route two non-GLP studies equivalent to OECD guidelines 410 (in rats) and 411 (in rabbits) are available for dipropylene glycol methyl ether. For the inhalation route, GLP-studies in rats and rabbits according to OECD guideline 413 and 412 are available for dipropylene glycol methyl ether. In addition, several non-GLP studies in rats, rabbits, guinea pigs and monkeys, similar to OECD guideline 452 were conducted with dipropylene glycol methyl ether. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44b7345a-60ea-48dd-886d-dffc40b4f1f5/documents/IUC5-d63439bd-e7dc-496f-bf4f-823324ac94ad_1f774ad6-f5d4-4119-a114-35ad40b04961.html,,,,,, (2-methoxymethylethoxy)propanol,34590-94-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44b7345a-60ea-48dd-886d-dffc40b4f1f5/documents/IUC5-d63439bd-e7dc-496f-bf4f-823324ac94ad_1f774ad6-f5d4-4119-a114-35ad40b04961.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat (2-methoxymethylethoxy)propanol,34590-94-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44b7345a-60ea-48dd-886d-dffc40b4f1f5/documents/IUC5-d63439bd-e7dc-496f-bf4f-823324ac94ad_1f774ad6-f5d4-4119-a114-35ad40b04961.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,850 mg/kg bw/day",,rabbit (2-methoxymethylethoxy)propanol,34590-94-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44b7345a-60ea-48dd-886d-dffc40b4f1f5/documents/IUC5-d63439bd-e7dc-496f-bf4f-823324ac94ad_1f774ad6-f5d4-4119-a114-35ad40b04961.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,232 mg/m3",,rat (2-methoxymethylethoxy)propanol,34590-94-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44b7345a-60ea-48dd-886d-dffc40b4f1f5/documents/IUC5-d63439bd-e7dc-496f-bf4f-823324ac94ad_1f774ad6-f5d4-4119-a114-35ad40b04961.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,232 mg/m3",no adverse effect observed,rat (2-methoxymethylethoxy)propanol,34590-94-8,Several non-GLP studies in rats and dogs equivalent to OECD guidelines 401 are available for dipropylene glycol methyl ether. For the inhalation route three non-GLP studies in rats equivalent or similar to OECD guideline 403 are available. For the dermal route three non-GLP studies (one in rats and two in rabbits) equivalent or similar to OECD guideline 403 are available. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44b7345a-60ea-48dd-886d-dffc40b4f1f5/documents/IUC5-cb8e3c89-c9cb-43b4-921f-0c92d6d58ca2_1f774ad6-f5d4-4119-a114-35ad40b04961.html,,,,,, (2-methoxymethylethoxy)propanol,34590-94-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44b7345a-60ea-48dd-886d-dffc40b4f1f5/documents/IUC5-cb8e3c89-c9cb-43b4-921f-0c92d6d58ca2_1f774ad6-f5d4-4119-a114-35ad40b04961.html,,dermal,LD50,"9,510 mg/kg bw",, A mixture of RR and RS isomers of: (2-(2-methoxy-1-methyl)ethoxy)-1-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-1-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1-methyl)ethoxy)-2-methylethyl acetate,88917-22-0,"A GLP-study according to OECD guideline 407 is available for dipropylene glycol methyl ether acetate. This data is supported by GLP-studies equivalent to OECD guidelines 407 and 413 for dipropylene glycol methyl ether. Further, several studies according to or similar to OECD guidelines 411 and 413 are provided for propylene glycol methyl ether and dipropylene glycol methyl ether. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0373cf52-5c4b-41ae-b68c-637206ff0652/documents/IUC5-fc627621-7678-47af-9da7-aba225b7e077_73560552-7347-4841-8801-699df0be46b9.html,,,,,, A mixture of RR and RS isomers of: (2-(2-methoxy-1-methyl)ethoxy)-1-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-1-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1-methyl)ethoxy)-2-methylethyl acetate,88917-22-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0373cf52-5c4b-41ae-b68c-637206ff0652/documents/IUC5-fc627621-7678-47af-9da7-aba225b7e077_73560552-7347-4841-8801-699df0be46b9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat A mixture of RR and RS isomers of: (2-(2-methoxy-1-methyl)ethoxy)-1-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-1-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1-methyl)ethoxy)-2-methylethyl acetate,88917-22-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0373cf52-5c4b-41ae-b68c-637206ff0652/documents/IUC5-fc627621-7678-47af-9da7-aba225b7e077_73560552-7347-4841-8801-699df0be46b9.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat A mixture of RR and RS isomers of: (2-(2-methoxy-1-methyl)ethoxy)-1-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-1-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1-methyl)ethoxy)-2-methylethyl acetate,88917-22-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0373cf52-5c4b-41ae-b68c-637206ff0652/documents/IUC5-fc627621-7678-47af-9da7-aba225b7e077_73560552-7347-4841-8801-699df0be46b9.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,212.27 mg/m3",,rat A mixture of RR and RS isomers of: (2-(2-methoxy-1-methyl)ethoxy)-1-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-1-methylethyl acetate; (2-(2-methoxy-2-methyl)ethoxy)-2-methylethyl acetate; (2-(2-methoxy-1-methyl)ethoxy)-2-methylethyl acetate,88917-22-0,"GLP-studies according to OECD guidelines 401 and 402 are available for dipropylene glycol methyl ether acetate. In addition, non-GLP studies equivalent to OECD guideline 403 are available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0373cf52-5c4b-41ae-b68c-637206ff0652/documents/IUC5-eecf1697-8025-4794-87ff-a0d5b6a1a892_73560552-7347-4841-8801-699df0be46b9.html,,,,,, "Tetradecan-1-ol, propoxylated, esters with propionic acid",74775-06-7," Based on the information available it can be concluded that the substance is not hazardous following short-term expsoure via the dermal route and the substance has a NOAEL of 1,000 mg/kg bw/day. An experiment for short-term repeated dose (28-day) oral toxicity has been waived as the dermal route is considered to be the most relevant route of administration for PPG-2 myristyl ether propionate and sufficient information is available to determine dermal toxicity following repeated dose. Equally, as the substance has a low vapour pressure and, therefore, volatility, it is not expected that human exposure via inhalation during use / production will occur. A short-term repeated dose (28-day) toxicity test for inhalation has subsequently been waived. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f15fb3b3-69d7-46ae-8c80-78c30e30264b/documents/b5645dfb-69be-4e00-8bb7-992ccd6a4cdd_6bdbf288-82b1-4bf2-b9cc-3a3e721281ec.html,,,,,, "Tetradecan-1-ol, propoxylated, esters with propionic acid",74775-06-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f15fb3b3-69d7-46ae-8c80-78c30e30264b/documents/b5645dfb-69be-4e00-8bb7-992ccd6a4cdd_6bdbf288-82b1-4bf2-b9cc-3a3e721281ec.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Tetradecan-1-ol, propoxylated, esters with propionic acid",74775-06-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f15fb3b3-69d7-46ae-8c80-78c30e30264b/documents/b5645dfb-69be-4e00-8bb7-992ccd6a4cdd_6bdbf288-82b1-4bf2-b9cc-3a3e721281ec.html,Repeated dose toxicity – local effects,dermal,NOAEL,"1,000 mg/cm2",no adverse effect observed,rat "Tetradecan-1-ol, propoxylated, esters with propionic acid",74775-06-7," A study to determine acute dermal toxicity was deemed not to be scientifically necessary for PPG-2 myristyl ether propionate. This is based on existing information presented in an acute oral test and an in vivo dermal irritation test that indicate a lack of toxicity. Following a 14-day in vivo toxicity study in Wistar-derived albino rats, it was found that oral administration of PPG-2 myristyl ether propionate at 5 g/kg did not result in any mortality or symptoms of toxicity. Subsequently, an LD50 of >5 g/kg was assigned to the substance and classification was demonstrated not to be necessary (CLP Regulation (EC) No. 1272/2008). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f15fb3b3-69d7-46ae-8c80-78c30e30264b/documents/dfaa5084-9ffd-4702-81cf-116885c7d713_6bdbf288-82b1-4bf2-b9cc-3a3e721281ec.html,,,,,, "Tetradecan-1-ol, propoxylated, esters with propionic acid",74775-06-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f15fb3b3-69d7-46ae-8c80-78c30e30264b/documents/dfaa5084-9ffd-4702-81cf-116885c7d713_6bdbf288-82b1-4bf2-b9cc-3a3e721281ec.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 1-(1-methyl-2-propoxyethoxy)propan-2-ol,29911-27-1," 13-week drinking water toxicity study in Fischer 344 rats including a 2 week range finding study, Reproduction/Developmental Toxicity Screening Test in CRL:CD(SD) Rats ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9a3b02a-402f-42eb-89ee-4b855db0800a/documents/4b125446-beaa-4c02-b4d2-24e90def521f_3703fc29-df8f-4256-bcf2-d9e63c934826.html,,,,,, 1-(1-methyl-2-propoxyethoxy)propan-2-ol,29911-27-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9a3b02a-402f-42eb-89ee-4b855db0800a/documents/4b125446-beaa-4c02-b4d2-24e90def521f_3703fc29-df8f-4256-bcf2-d9e63c934826.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat 1-(1-methyl-2-propoxyethoxy)propan-2-ol,29911-27-1," Acute oral studies in Rats (Fisher 344 and Wistar), Acute dermal study in New Zealand White Rabbits. Acute inhalation study in Sprague-Dawley albino rats.  A review of the three studies available by the acute route concluded that the LD50 is above 2000 mg/kgbw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9a3b02a-402f-42eb-89ee-4b855db0800a/documents/9851939f-a06c-40d0-817e-ed44f831f541_3703fc29-df8f-4256-bcf2-d9e63c934826.html,,,,,, [(butoxymethylethoxy)methylethoxy]propan-1-ol,55934-93-5,GLP-studies in rats according to OECD guidelines 407 (oral gavage) and 408 (drinking water) are available for tripropylene glycol butyl ether. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/882d77c6-b1cc-49e7-b027-1b0486e5812e/documents/IUC5-4c24fc97-89ae-4ef5-a946-2521e56c432e_74542247-c047-461b-9519-8a2ebc8ab338.html,,,,,, [(butoxymethylethoxy)methylethoxy]propan-1-ol,55934-93-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/882d77c6-b1cc-49e7-b027-1b0486e5812e/documents/IUC5-4c24fc97-89ae-4ef5-a946-2521e56c432e_74542247-c047-461b-9519-8a2ebc8ab338.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat [(butoxymethylethoxy)methylethoxy]propan-1-ol,55934-93-5,GLP-studies according to OECD guidelines 401 and 402 are available for tripropylene glycol butyl ether. This data is supported by non-GLP studies equivalent to OECD guidelines 401 and 402 . ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/882d77c6-b1cc-49e7-b027-1b0486e5812e/documents/IUC5-d64b212f-7c95-4bdf-b62a-4d430ce51501_74542247-c047-461b-9519-8a2ebc8ab338.html,,,,,, [(butoxymethylethoxy)methylethoxy]propan-1-ol,55934-93-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/882d77c6-b1cc-49e7-b027-1b0486e5812e/documents/IUC5-d64b212f-7c95-4bdf-b62a-4d430ce51501_74542247-c047-461b-9519-8a2ebc8ab338.html,,oral,LD50,"2,600 mg/kg bw",adverse effect observed, "Glycerol, propoxylated, esters with acrylic acid",52408-84-1,"OECD 408, oral, rat: NOAEL local: 150 mg/kg, NOAEL systemic: 375 mg/kg (highest dose) OECD 422, oral, rat: NOAEL local: 150mg/kg, NOAEL systemic: 375mg/kg (mortality likely secondary to local effects at 750 mg/kg) 10 applications (12 days), dermal, rat: severe local irriation, consequently red. b.w. at 500 mg/kg (only dose tested) 10 applications (14 days incl. a 2 week recovery group), dermal, rabbit: severe local irriation, consequently red. b.w. gain at 500 mg/kg (only dose tested)   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/59c69996-36fc-4a15-893c-f11c3a06878d/documents/IUC5-f77d66da-d3d5-4672-9a89-81b631915563_0cf0a8e7-78b5-4170-a271-6e23fd2ca7be.html,,,,,, "Glycerol, propoxylated, esters with acrylic acid",52408-84-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/59c69996-36fc-4a15-893c-f11c3a06878d/documents/IUC5-f77d66da-d3d5-4672-9a89-81b631915563_0cf0a8e7-78b5-4170-a271-6e23fd2ca7be.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,>= 375 mg/kg bw/day,,rat "Glycerol, propoxylated, esters with acrylic acid",52408-84-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/59c69996-36fc-4a15-893c-f11c3a06878d/documents/IUC5-f77d66da-d3d5-4672-9a89-81b631915563_0cf0a8e7-78b5-4170-a271-6e23fd2ca7be.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,375 mg/kg bw/day,,rat "Glycerol, propoxylated, esters with acrylic acid",52408-84-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/59c69996-36fc-4a15-893c-f11c3a06878d/documents/IUC5-f77d66da-d3d5-4672-9a89-81b631915563_0cf0a8e7-78b5-4170-a271-6e23fd2ca7be.html,Repeated dose toxicity – local effects,dermal,LOAEL,4.4 mg/cm2,adverse effect observed,rat "Glycerol, propoxylated, esters with acrylic acid",52408-84-1,"Acute oral, rat: LD50 > 2000mg/kg Acute derma, rat: LD50 > 2000 mg/kg ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59c69996-36fc-4a15-893c-f11c3a06878d/documents/IUC5-b0468ae9-a102-4308-840f-de252ceb5bd7_0cf0a8e7-78b5-4170-a271-6e23fd2ca7be.html,,,,,, "Glycerol, propoxylated, esters with acrylic acid",52408-84-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59c69996-36fc-4a15-893c-f11c3a06878d/documents/IUC5-b0468ae9-a102-4308-840f-de252ceb5bd7_0cf0a8e7-78b5-4170-a271-6e23fd2ca7be.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Glycerol, propoxylated, esters with acrylic acid",52408-84-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59c69996-36fc-4a15-893c-f11c3a06878d/documents/IUC5-b0468ae9-a102-4308-840f-de252ceb5bd7_0cf0a8e7-78b5-4170-a271-6e23fd2ca7be.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Castor oil, hydrogenated, propoxylated",111870-68-9," In a study according to OECD 422, oral administration (by gavage) of the analogue, Castor oil, hydrogenated, ethoxylated, to Wistar rats at the doses of 100, 300 and 1000 mg/kg/day for two weeks prior to mating and up to the day before sacrifice inclusive (males) or up to days 13-15 of lactation (females) was well tolerated. No test item related mortality was recorded during the study. There were no signs of evident toxicity related to clinical signs, sensory reactivity, grip strength or motor activity. Regarding body weights and food consumption, lower mean values with respect to Control were recorded in males as well as for food consumption in females. However, given the magnitude observed and the fact that the effect in food consumption was also recorded during pre-test, it needs to be considered as a non-adverse effect. The statistical differences observed in in hematology, coagulation or clinical biochemistry were not considered to be test item related, based on the magnitude and in the absence of a dose relation. These values were within those observed in rats of this strain and age and were there attributed to normal biological variation. There was no indication of an effect of the substance on T4 levels and there was no evidence of a test-item effect in the histopathology performed on F0 adults. There were no changes in the macroscopic examination or organ weights that could be attributable to the substance. Administration of the substance to Wistar rats by oral gavage for 5-8 weeks was not associated with macro/micropathological findings in this study. In the testes, seminiferous tubules were evaluated with respect to their stage in the spermatogenic cycle and the integrity of the various cell types present within the different stages. No cell or stage-specific abnormalities were noted in males treated at 1000 mg/kg. The NOAEL for repeated dose toxicity was considered to be 1000 mg/kg/day for males and females, taking into account the slight decrease in food consumption and body weights. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfacbea2-c512-4f94-8cf2-abf989bd399d/documents/7aae24b3-74a6-4af3-95a1-2b52f31b25c2_2c0720ee-b26d-414e-b9e5-cf4c1a628fb6.html,,,,,, "Castor oil, hydrogenated, propoxylated",111870-68-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfacbea2-c512-4f94-8cf2-abf989bd399d/documents/7aae24b3-74a6-4af3-95a1-2b52f31b25c2_2c0720ee-b26d-414e-b9e5-cf4c1a628fb6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Castor oil, hydrogenated, propoxylated",111870-68-9," In a fixed dose procedure 5 female rats received a single dose of 2000 mg/kg bw of an analogue substance by gavage. Rats were observed for 14 days thereafter. No mortality occurred. One female showed hunched posture, ataxia, noisy respiration, increased salivation and lethargy during the first day. The other females showed hunched posture during the first 2 hours after dosing. There were no effects on body weight and no macroscopic findings. Based on these findings the oral LD50 of the substance is > 2000 mg/kg bw. As the analogue substance is of low acute oral toxicity, is not classified as STOT SE and there are no other signs of systemic toxicity, the acute dermal toxicity study has been waived. As the inhalation exposure route is not relevant for this substance no acute study via the inhalation route is included. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfacbea2-c512-4f94-8cf2-abf989bd399d/documents/f030bd05-790d-4d5c-8b6e-f85c7ab53442_2c0720ee-b26d-414e-b9e5-cf4c1a628fb6.html,,,,,, "Castor oil, hydrogenated, propoxylated",111870-68-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfacbea2-c512-4f94-8cf2-abf989bd399d/documents/f030bd05-790d-4d5c-8b6e-f85c7ab53442_2c0720ee-b26d-414e-b9e5-cf4c1a628fb6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, [2-(2-methoxymethylethoxy)methylethoxy]propanol,25498-49-1,A non-GLP study with dermal application of tripropylene glycol methyl ether over 90-days to rabbits and a GLP-study according to OECD guideline 412 (2-week inhalation exposure in rats and mice) are available for tripropylene glycol methyl ether. Supporting data from category member DPM (refer to category document attached to section 13 of the IUCLID). ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b3514fc-6a9e-4fc8-90f6-270b2b7f6164/documents/IUC5-3e818b85-ca1c-43d0-88bf-386c8d195009_024507d9-210c-49fe-8b5b-aa1f6090c45a.html,,,,,, [2-(2-methoxymethylethoxy)methylethoxy]propanol,25498-49-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b3514fc-6a9e-4fc8-90f6-270b2b7f6164/documents/IUC5-3e818b85-ca1c-43d0-88bf-386c8d195009_024507d9-210c-49fe-8b5b-aa1f6090c45a.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,010 mg/m3",,rat [2-(2-methoxymethylethoxy)methylethoxy]propanol,25498-49-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b3514fc-6a9e-4fc8-90f6-270b2b7f6164/documents/IUC5-3e818b85-ca1c-43d0-88bf-386c8d195009_024507d9-210c-49fe-8b5b-aa1f6090c45a.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,965 mg/kg bw/day,,rabbit [2-(2-methoxymethylethoxy)methylethoxy]propanol,25498-49-1,"Two GLP-studies according to OECD guideline 401 are available supported by two non-GLP studies equivalent to OECD guideline 401. For the inhalation route a non-GLP study equivalent to OECD guideline 403 is available, which is supported by a study published in the peer-reviewed literature. Two non-GLP studies equivalent to OECD guideline 402 are available for tripropylene glycol methyl ether. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b3514fc-6a9e-4fc8-90f6-270b2b7f6164/documents/IUC5-6927cc28-06e4-47ad-b845-7534814460f4_024507d9-210c-49fe-8b5b-aa1f6090c45a.html,,,,,, [2-(2-methoxymethylethoxy)methylethoxy]propanol,25498-49-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b3514fc-6a9e-4fc8-90f6-270b2b7f6164/documents/IUC5-6927cc28-06e4-47ad-b845-7534814460f4_024507d9-210c-49fe-8b5b-aa1f6090c45a.html,,oral,LD50,"3,400 mg/kg bw",adverse effect observed, [2-(2-methoxymethylethoxy)methylethoxy]propanol,25498-49-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b3514fc-6a9e-4fc8-90f6-270b2b7f6164/documents/IUC5-6927cc28-06e4-47ad-b845-7534814460f4_024507d9-210c-49fe-8b5b-aa1f6090c45a.html,,dermal,LD50,"15,440 mg/kg bw",adverse effect observed, Prasterone,53-43-0,"No repeated dose studies available for the substance. The outcomes of chronic studies in rat and dogs investigating the structural analogue & precursor Prasterone enantate, which is known to release Prasteron in vivo, in combination with estradiol-valerinate were instead used for classification. The studies on rats and dogs, with intramuscular administration, reveal effects (predominantly regressive changes on reproductive tissues) related to the endocrine nature of the substance. [Schering AG, Report No. 174, 1971-10-25; Schering AG, Report No. 283, 1971-10-25]This mode of action is confirmed by published data cited in RTECS.No classification is concluded for repeated dose toxicity, but for reproductive toxicity/fertility. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d89f8250-8872-481e-9ffe-7aee2ae988c2/documents/35eddba3-c643-443b-ad1c-74ca1b73b572_c63fde44-aa6f-4f25-890f-e49bed11afba.html,,,,,, Prasterone,53-43-0,"Oral (Rat): LD50 > 3300 mg/kg (formulated in fatty ointment) [Schering AG, Report No. 838, 1973-01-22] Oral (Female Mouse): LD50 > 4130 mg/kg (formulated in fatty ointment) [Schering AG, Report No. 848, 1973-01-18] Oral (Male Mouse): LD50 > 4130 mg/kg (formulated in fatty ointment) [Schering AG, Report No. 846, 1973-01-18] Oral (Dog): LD50 > 4000 mg/kg (formulated in fatty ointment, administered in gelatine capsules) [Schering AG, Report No. 843, 1973-01-17] Published data cited in RTECS confirm the low acute toxicity for the substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 2 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d89f8250-8872-481e-9ffe-7aee2ae988c2/documents/5a2913d3-bd90-411b-bb0d-4790a4c0e2fc_c63fde44-aa6f-4f25-890f-e49bed11afba.html,,,,,, Prasterone,53-43-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d89f8250-8872-481e-9ffe-7aee2ae988c2/documents/5a2913d3-bd90-411b-bb0d-4790a4c0e2fc_c63fde44-aa6f-4f25-890f-e49bed11afba.html,,oral,LD50,"> 3,300 mg/kg bw",adverse effect observed, 3-methylbut-2-en-1-ol,556-82-1,"Repeated dose toxicity – oral: subchronic study; rat, drinking water; OECD TG 408, GLP (BASF52C0274/00099): NOAEL (male) = 65.4 mg/kg bw; NOAEL (female) = 82.1 mg/kg bw ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b68bad82-42f6-45e2-b8e7-dfb6fa306a6c/documents/IUC5-ae430d5f-e626-460c-a079-93169e5fa879_11c3218b-adc2-48ed-a6bc-057974d5e8c7.html,,,,,, 3-methylbut-2-en-1-ol,556-82-1,"Acute oral toxicity: LD50 = 1591 mg/kg bw, (rat, similar to OECD Guideline 401, BASFXX/24)Acute dermal toxicity: LD50 > 4000 mg/kg bw (rat, similar to OECD Guideline 402, BASFXX/24) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b68bad82-42f6-45e2-b8e7-dfb6fa306a6c/documents/IUC5-b1faf17b-fbab-4b03-b3fc-26f0bd5d657e_11c3218b-adc2-48ed-a6bc-057974d5e8c7.html,,,,,, 3-methyl-2-butenyl acetate,1191-16-8,"Repeated dose toxicity – oral (drinking water, OECD 408, GLP; read-across prenol; CAS No. 556-82-1): NOAEL (male) = 65.4 mg/kg bw/d;NOAEL (female) = 82.1 mg/kg bw/d , subchronic study; rat, drinking water; OECD TG 408, RL1 (BASF, 2002): . ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f934727-6847-4541-9de7-6fcc9e611f49/documents/IUC5-98b1d8f5-e3fa-435a-950f-fb7600bc58ae_1b7d60ad-9f07-4920-ab93-cec2ac71115c.html,,,,,, 3-methyl-2-butenyl acetate,1191-16-8,"- Acute oral toxicity: LD50 = 3000/2900 (males/females; TSCATS, 1978)- Acute dermal toxicity: LD50 > 5000 mg/kg bw in rabbits (Moreno, 1977) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f934727-6847-4541-9de7-6fcc9e611f49/documents/IUC5-b404eaff-1433-4315-852b-5e13a91da078_1b7d60ad-9f07-4920-ab93-cec2ac71115c.html,,,,,, Progesterone,57-83-0,"A study in Spraque-Dawley Rats with daily intragastrically application over a period of 5 days revealed apathy and slightly decreased body weight gain during the treatment and reversibility period. Female rhesus monkeys had acyclic menses, lack of vaginal cornification, increase of parenchymal breast cells and lacktic efflux after treatment with 5.0 and 50.0 mg/kg Progesterone. Further data from animal studies implicate an effect on tumorigenesis in female reproductive organs.The endogenous production of progesterone during pregnancy amounts to an estimated 200 mg per day and orally administered progesterone is inactivated very rapidly in the liver so no organ toxic effects have to be reckoned with after repeated oral exposure to dose levels of this order of magnitude. However, known side effects of progestogens in humans such as headache, gastro-intestinal disturbances, weight increase and impairment of liver function have also to be reckoned after repeated exposure to progesterone. The therapeutic dose level for parenteral administration begins with appr. 5 to 10 mg/person/day. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e5cd2ec-9a6b-4fa7-aab6-dfc804982637/documents/IUC5-ac552c3c-0884-4533-9eb2-c7a149bfb401_2309cf66-df64-4e49-a193-2a7923ac4990.html,,,,,, Progesterone,57-83-0,Only limited information is available concerning acute toxicity of Progesterone. On basis of the low acute toxicity of progesterone after single parenteral administration and the known oral LD50 values for this group of steroidal compounds no risk of acute poisoning has to be assumed after single uptake of progesterone. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e5cd2ec-9a6b-4fa7-aab6-dfc804982637/documents/IUC5-e686c1b8-f0a9-4800-95d2-78e00c9569e7_2309cf66-df64-4e49-a193-2a7923ac4990.html,,,,,, L-proline,147-85-3,L-proline did not show adverse effects in two independent 13 week oral toxicity studies up to high doses. All data from the oral route of administration suggest that they sufficiently cover the dermal and inhalative routes. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f8d9cb5-191f-480f-a50e-87098d4a06d7/documents/IUC5-248ee1e5-fe51-471f-aaee-e91458b5e449_0e76b9fc-99ff-441c-a102-e886239d44fd.html,,,,,, L-proline,147-85-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f8d9cb5-191f-480f-a50e-87098d4a06d7/documents/IUC5-248ee1e5-fe51-471f-aaee-e91458b5e449_0e76b9fc-99ff-441c-a102-e886239d44fd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,773 mg/kg bw/day",,rat L-proline,147-85-3,An acute oral LD50 value of > 5110mg/kg bw from a reliable study was derived. No mortality occured during the observation period of 14 days. No signs of toxicity were observed either at the male nor the female animals. The acute dermal study and the acute inhalation study were waived based on the very low systemic toxicity as well as on the physico-chemical and toxikokinetic properties. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f8d9cb5-191f-480f-a50e-87098d4a06d7/documents/IUC5-1f0fd747-195f-459b-86c7-e97e19e58f45_0e76b9fc-99ff-441c-a102-e886239d44fd.html,,,,,, L-proline,147-85-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f8d9cb5-191f-480f-a50e-87098d4a06d7/documents/IUC5-1f0fd747-195f-459b-86c7-e97e19e58f45_0e76b9fc-99ff-441c-a102-e886239d44fd.html,,oral,LD50,"5,110 mg/kg bw",no adverse effect observed, "Propane-1,3-diol",504-63-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98017b9c-f413-4880-a8e2-ee5a085d1666/documents/IUC5-ec5bf5fb-8718-4207-a849-c9fd47c30ed1_49563d12-6f31-4a04-8e80-c386b4dddbf2.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,800 mg/m3",,rat "Propane-1,3-diol",504-63-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98017b9c-f413-4880-a8e2-ee5a085d1666/documents/IUC5-ec5bf5fb-8718-4207-a849-c9fd47c30ed1_49563d12-6f31-4a04-8e80-c386b4dddbf2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, "Propane-1,3-diol",504-63-2," The substance has low oral toxicity with a rat LD50 value of greater than 2000 mg/kg, low inhalation toxicity with a rat acute lethal dose greater than the highest dose tested of 1800 mg/m3, and low dermal toxicity with a rat LD50 of greater than 4200 mg/kg/day. Acute toxicity by the oral route of exposure was associated with sluggishness, ataxia, and sedation at high concentrations. Acute toxicity by the inhalation route of exposure was associated with wet fur/perineum and ocular discharge at high concentrations. The acute effects were associated with exposure concentration. Systemic activity was not observed with inhalation and dermal routes of exposure. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98017b9c-f413-4880-a8e2-ee5a085d1666/documents/IUC5-6178808f-2b72-4dc1-a168-d3d95ab997c2_49563d12-6f31-4a04-8e80-c386b4dddbf2.html,,,,,, 3-hydroxypropyl octanoate,102731-54-4,"A repeated dose toxicity study does not need to be conducted according to REACH Annex XI, 1.2, Weight of Evidence (WoE). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP and Guideline study ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6dc4777-db97-45ca-8169-2263e0466f95/documents/24a53d86-8e41-46bd-958d-f7ab7f9945e9_b73a3ca9-cca3-46e3-88c1-e459df4c9082.html,,,,,, 3-hydroxypropyl octanoate,102731-54-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6dc4777-db97-45ca-8169-2263e0466f95/documents/24a53d86-8e41-46bd-958d-f7ab7f9945e9_b73a3ca9-cca3-46e3-88c1-e459df4c9082.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 3-hydroxypropyl octanoate,102731-54-4,"No data on the test item is available. With the read-across substances the following results were obtained: Acute oral, rat (CAS 504-63-2): Discriminating dose > 9450 mg/kg bw Acute oral, rat (CAS 124-07-2): LD50 > 10000 mg/kg Acute intraperitoneal, rat (CAS 504-63-2): LD50 > 2000 mg/kg bw Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Peer reviewed publications ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6dc4777-db97-45ca-8169-2263e0466f95/documents/f19f1923-e006-4a15-99ba-110cd5248943_b73a3ca9-cca3-46e3-88c1-e459df4c9082.html,,,,,, 3-hydroxypropyl octanoate,102731-54-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6dc4777-db97-45ca-8169-2263e0466f95/documents/f19f1923-e006-4a15-99ba-110cd5248943_b73a3ca9-cca3-46e3-88c1-e459df4c9082.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "propane-1,3-diyl dioctanoate",56519-71-2,"NOAEL oral, systemic ≥1000 mg/kg bw/d (OECD 408) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a64aaeb-d9f2-4cca-a974-c4f7df9a806e/documents/IUC5-385586bb-d353-4496-9edf-04695ff529c1_0e69200c-8872-447d-99e7-6868c7b120f8.html,,,,,, "propane-1,3-diyl dioctanoate",56519-71-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a64aaeb-d9f2-4cca-a974-c4f7df9a806e/documents/IUC5-385586bb-d353-4496-9edf-04695ff529c1_0e69200c-8872-447d-99e7-6868c7b120f8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "propane-1,3-diyl dioctanoate",56519-71-2,"1,3-propanediol dicaprylate is considered to non toxic upon ingestion. The predicted LD50 for rats is >2000 mg/kg bw. This weight-of-evidence assessment is based on experimental data on the metabolites propane-1,3-diol and caprylic acid as well as on experimental data on structurally related esters.1,3-propanediol dicaprylate is considered to non toxic upon dermal application. The predicted LD50 for rats is > 2000 mg/kg bw. This weight-of-evidence assessment is based on modeling of skin permeability, skin metabolism, and experimental data for oral toxicity on the metabolites propane-1,3-diol and octanoic acid as well as on experimental data on structurally related esters. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a64aaeb-d9f2-4cca-a974-c4f7df9a806e/documents/IUC5-519e35e1-0ea6-48c8-8b1f-3cd7aa0ec39d_0e69200c-8872-447d-99e7-6868c7b120f8.html,,,,,, "propane-1,3-diyl dioctanoate",56519-71-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a64aaeb-d9f2-4cca-a974-c4f7df9a806e/documents/IUC5-519e35e1-0ea6-48c8-8b1f-3cd7aa0ec39d_0e69200c-8872-447d-99e7-6868c7b120f8.html,,oral,LD50,"2,000 mg/kg bw",, "propane-1,3-diyl dioctanoate",56519-71-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a64aaeb-d9f2-4cca-a974-c4f7df9a806e/documents/IUC5-519e35e1-0ea6-48c8-8b1f-3cd7aa0ec39d_0e69200c-8872-447d-99e7-6868c7b120f8.html,,dermal,LD50,"2,000 mg/kg bw",, Propionic acid,79-09-4,"OralSubchronic repeated dose toxicityNOAEL (90d, dog) = 10000 ppm (approx 733 mg/kg bw)Chronic repeated dose toxicityLOAEL (local toxicity, rats, life time study): 400 ppm (264 mg/kg bw) NOAEL (systemic toxicity, rats, life time study): 4000 ppm(2640 mg/kg bw) DermalLOAEL (90 d, mouse, local effects) = 136.9 mg/kg bw ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/936d17e1-dd76-4f9d-b233-ad83949f297e/documents/IUC5-3181d25b-94b8-4ca9-bcbb-5d390e184da5_103c5a42-4526-4f94-9b33-6bbf7deb9661.html,,,,,, Propionic acid,79-09-4,Acute oral toxicity- LD50 (male and female: rat): 3455.1 mg/kg bw (2978.9-4007.5) (BASF AG 1969)Acute inhalation toxicity:LC50 is supposed to be > 20 mg/L /4h (vapor) based onthe available information (BASF 1969; Smyth et al. 1962)Acute dermal toxicity- LD50 (female: rat): 3235 mg/kg bw (Hoechst 1975) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/936d17e1-dd76-4f9d-b233-ad83949f297e/documents/IUC5-6739b8ad-b1c5-4b60-9456-3342a0b753b4_103c5a42-4526-4f94-9b33-6bbf7deb9661.html,,,,,, Propionic acid,79-09-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/936d17e1-dd76-4f9d-b233-ad83949f297e/documents/IUC5-6739b8ad-b1c5-4b60-9456-3342a0b753b4_103c5a42-4526-4f94-9b33-6bbf7deb9661.html,,oral,LD50,"3,455 mg/kg bw",adverse effect observed, Propyl acetate,109-60-4,90d inhalation NOAEC (local effects) = 150 ppm; NOAEC (specific systemic target organ toxicity) = 1500 ppm. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb926789-00ff-4383-9abb-64856ba7508c/documents/IUC5-23e4250b-4741-4548-a759-5f35e1fba11c_e3ffacd1-ba5f-4972-a1a0-be0425e64628.html,,,,,, Propyl acetate,109-60-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb926789-00ff-4383-9abb-64856ba7508c/documents/IUC5-23e4250b-4741-4548-a759-5f35e1fba11c_e3ffacd1-ba5f-4972-a1a0-be0425e64628.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"6,478.3 mg/m3",,rat Propyl acetate,109-60-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb926789-00ff-4383-9abb-64856ba7508c/documents/IUC5-23e4250b-4741-4548-a759-5f35e1fba11c_e3ffacd1-ba5f-4972-a1a0-be0425e64628.html,Repeated dose toxicity – local effects,inhalation,NOAEC,629.3 mg/m3,adverse effect observed,rat Propyl acetate,109-60-4,"Oral LD50 oral, rat ca. 8700 mg/kg) Dermal LD50 dermal, rabbit ca. 17800 mg/kg Inhalation LC50 rat (4H) vapour =  32 mg/L ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb926789-00ff-4383-9abb-64856ba7508c/documents/IUC5-a7f7005b-a605-4b3b-b23e-c4e6f997d83e_e3ffacd1-ba5f-4972-a1a0-be0425e64628.html,,,,,, Propyl acetate,109-60-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb926789-00ff-4383-9abb-64856ba7508c/documents/IUC5-a7f7005b-a605-4b3b-b23e-c4e6f997d83e_e3ffacd1-ba5f-4972-a1a0-be0425e64628.html,,oral,LD50,"8,700 mg/kg bw",no adverse effect observed, Propyl acetate,109-60-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb926789-00ff-4383-9abb-64856ba7508c/documents/IUC5-a7f7005b-a605-4b3b-b23e-c4e6f997d83e_e3ffacd1-ba5f-4972-a1a0-be0425e64628.html,,dermal,LD50,"17,800 mg/kg bw",no adverse effect observed, Propyl acetate,109-60-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb926789-00ff-4383-9abb-64856ba7508c/documents/IUC5-a7f7005b-a605-4b3b-b23e-c4e6f997d83e_e3ffacd1-ba5f-4972-a1a0-be0425e64628.html,,inhalation,LC50,"32,000 mg/m3",no adverse effect observed, Propan-1-ol,71-23-8,"OECD TG No. 413, GLP, reliability 1, rat: NOAEC > 5200 ppm ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25f30a2c-93d7-41b4-a2a4-c0d62a43eb03/documents/IUC5-91f4af33-0355-4c74-a6d5-f72784d066c2_5c6dc68e-a2be-4907-8b6d-803fc3f09ae6.html,,,,,, Propan-1-ol,71-23-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25f30a2c-93d7-41b4-a2a4-c0d62a43eb03/documents/IUC5-91f4af33-0355-4c74-a6d5-f72784d066c2_5c6dc68e-a2be-4907-8b6d-803fc3f09ae6.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"5,200 ",, Propan-1-ol,71-23-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25f30a2c-93d7-41b4-a2a4-c0d62a43eb03/documents/IUC5-91f4af33-0355-4c74-a6d5-f72784d066c2_5c6dc68e-a2be-4907-8b6d-803fc3f09ae6.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"5,200 ",no adverse effect observed, Propan-1-ol,71-23-8,"The oral LD50 ranges from 1870, 5400, 6500 to 8000 mg/kg in the rat. For rabbits this value is 2823 mg/kg and for the mouse 5467 mg/kg.   The inhalative LC50 value was determined to be greater than 33.8 mg/l.   The dermal LD50 value is 4052 mg/kg for the rabbit.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25f30a2c-93d7-41b4-a2a4-c0d62a43eb03/documents/IUC5-75e8be12-196a-4b63-82e6-cfecabc067a5_5c6dc68e-a2be-4907-8b6d-803fc3f09ae6.html,,,,,, Propan-1-ol,71-23-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25f30a2c-93d7-41b4-a2a4-c0d62a43eb03/documents/IUC5-75e8be12-196a-4b63-82e6-cfecabc067a5_5c6dc68e-a2be-4907-8b6d-803fc3f09ae6.html,,oral,LD50,"8,000 mg/kg bw",adverse effect observed, Propan-1-ol,71-23-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25f30a2c-93d7-41b4-a2a4-c0d62a43eb03/documents/IUC5-75e8be12-196a-4b63-82e6-cfecabc067a5_5c6dc68e-a2be-4907-8b6d-803fc3f09ae6.html,,dermal,LD50,"4,032 mg/kg bw",adverse effect observed, Propan-1-ol,71-23-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25f30a2c-93d7-41b4-a2a4-c0d62a43eb03/documents/IUC5-75e8be12-196a-4b63-82e6-cfecabc067a5_5c6dc68e-a2be-4907-8b6d-803fc3f09ae6.html,,inhalation,LC50,"33,785.7 mg/m3",adverse effect observed, "Propyl 3,4,5-trihydroxybenzoate",121-79-9," Several studies for repeated dose toxicity are available for the target substance propyl gallate. In a 13-week study from Speijers et al. (1993) conducted similar to OECD 408, propyl gallate (> 98% purity) was administered to 10 male and 10 female Wistar rats per dose by feed at dose levels of 0, 490, 1910 and 7455 mg/kg diet. Based on the results obtained from this study, the NOAEL can be considered to be 1910 mg propyl gallate/kg diet, corresponding to 135 mg/kg body weight. In a chronic carcinogenicity study conducted by the US NTP, F344/N rats and B6CF1 mice (both sexes) received daily by diet containing 0, 6000 and 12000 ppm propyl gallate for 103 weeks. The LOAEL values of 298 mg/kg (male rats), 332 mg/kg (female rats), 1141 mg/kg (male mice) and 1591 mg/kg (female mice) were determined based on the results of this study. Altogether, the NOAEL of 135 mg/kg body weight based on adverse effects in the haematopoietic system (Speijers et al., 1993) was considered for further assessment of this toxicological endpoint. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41257f7c-4905-48ba-a2ed-daa98261056d/documents/4e52be63-e82e-456a-b105-ffc0b08d705d_47334341-c60e-42a9-8de8-bab45ed4c2eb.html,,,,,, "Propyl 3,4,5-trihydroxybenzoate",121-79-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41257f7c-4905-48ba-a2ed-daa98261056d/documents/4e52be63-e82e-456a-b105-ffc0b08d705d_47334341-c60e-42a9-8de8-bab45ed4c2eb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,135 mg/kg bw/day,,rat "Propyl 3,4,5-trihydroxybenzoate",121-79-9," In acute oral toxicity study, mice (5/sex/dose) received orally 125, 250, 500, 1000 and 2000 mg/kg bw. One of five male and 3 of five females died within 2 hours after dosing. No mortality occurred among the lower dose groups and no other compound-related effects were observed. Based on these results, a LD50 between 1000 and 2000 mg/kg bw was determined for female mice. This data is in line with the harmonized classification of propyl gallate (Acute Tox 4, H302). Supporting information was presented in the review publications by EFSA, 2014 and by CIR, 2007. In both publications an oral LD50 of 1700 mg/kg bw was reported for mice, which further supports the harmonized classification.   In an acute dermal toxicity study (OECD 402) a group of young adults Wistar rats (5 /sex) were dermally exposed to propyl gallate for 24 hours to approximately 10% of body surface area at dose of 2000 mg/kg bw. Animals then were observed for 14 days. No mortality neither signs of toxicity nor signs of irritation occurred. The dermal LD50 value of propyl gallate in Wistar rats was established to exceed 2000 mg/kg body weight. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41257f7c-4905-48ba-a2ed-daa98261056d/documents/def20648-57e4-47bf-9cb0-315bd26852f3_47334341-c60e-42a9-8de8-bab45ed4c2eb.html,,,,,, Propyl propionate,106-36-5,"There is a 28-day repeated dose inhalation study in rats available for n-propyl propionate and there are no repeated dose oral or dermal studies available. In addition, there are several repeated dose inhalation studies ranging from 9 days to 90 days in duration for the other substances in the category, n-pentyl propionate and n-butyl propionate refer to the justification for read across attached to section 13 of the dataset). The only common finding across all the studies has been histopathologic changes in the nasal tissues (olfactory epithelium damage) and this can be considered to be a local effect, while again across all the studies there have been no major indications of any systemic toxicity up to the highest doses tested. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e4afa07-1dc1-4024-9e42-9c8318e2f63d/documents/e7e89806-e45e-4e0b-8305-b161e3138d7e_8176c0d4-75a0-4186-8956-8e6fdaeeeada.html,,,,,, Propyl propionate,106-36-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e4afa07-1dc1-4024-9e42-9c8318e2f63d/documents/e7e89806-e45e-4e0b-8305-b161e3138d7e_8176c0d4-75a0-4186-8956-8e6fdaeeeada.html,Repeated dose toxicity – local effects,inhalation,NOAEC,238 mg/m3,adverse effect observed,rat Propyl propionate,106-36-5,"Acute oral - In a non-GLP study conducted with study methodology equivalent to OECD TG 401, Under the conditions of the study, as the oral LD50 of n-propyl propionate is in excess of 10000 mg/kg (male LD50 – 11.7 ml/kg ~ 10258.67 mg/kg and female LD50 – 12.6 ml/kg ~ 11047.80 mg/kg; conversions based on density of 0.87681 g/cc at 25 °C), Acute dermal - In a non-GLP study conducted with study methodology equivalent to OECD TG 402, the acute dermal LD50 value for propyl propionate was 14028.96 mg/kg (Conversion from ml/kg resulted in - 16 ml/kg - 14028.96 mg/kg)Acute inhalation - In a non-GLP study conducted with study methodology equivalent to OECD TG 403, the lethal time LT50 of propyl propionate to male and female Spraque-Dawley rats exposed to saturated vapors over a period of 6 hours was 66 mL/l. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e4afa07-1dc1-4024-9e42-9c8318e2f63d/documents/IUC5-21e275f5-e77c-4157-abfa-ef70cb041427_8176c0d4-75a0-4186-8956-8e6fdaeeeada.html,,,,,, Propyl propionate,106-36-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e4afa07-1dc1-4024-9e42-9c8318e2f63d/documents/IUC5-21e275f5-e77c-4157-abfa-ef70cb041427_8176c0d4-75a0-4186-8956-8e6fdaeeeada.html,,oral,LD50,"10,259 mg/kg bw",adverse effect observed, Propyl propionate,106-36-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e4afa07-1dc1-4024-9e42-9c8318e2f63d/documents/IUC5-21e275f5-e77c-4157-abfa-ef70cb041427_8176c0d4-75a0-4186-8956-8e6fdaeeeada.html,,dermal,LD50,"14,029 mg/kg bw",no adverse effect observed, Propyl propionate,106-36-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e4afa07-1dc1-4024-9e42-9c8318e2f63d/documents/IUC5-21e275f5-e77c-4157-abfa-ef70cb041427_8176c0d4-75a0-4186-8956-8e6fdaeeeada.html,,inhalation,LC50,"66,000 mg/m3",no adverse effect observed, Dipropoxymethane,505-84-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab583ea1-c9de-4452-b906-8e44a6af87a4/documents/fc0ffaf0-4473-4924-af96-f272b7c7932f_2fe1b774-3da9-4dcc-a3ba-e36e968e2222.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dipropoxymethane,505-84-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab583ea1-c9de-4452-b906-8e44a6af87a4/documents/fc0ffaf0-4473-4924-af96-f272b7c7932f_2fe1b774-3da9-4dcc-a3ba-e36e968e2222.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"16,665 mg/m3",,rat Dipropoxymethane,505-84-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab583ea1-c9de-4452-b906-8e44a6af87a4/documents/IUC5-7735793e-adf4-4417-8fd2-a864b674b2c7_2fe1b774-3da9-4dcc-a3ba-e36e968e2222.html,,oral,LD50,500 mg/kg bw,no adverse effect observed, Dipropoxymethane,505-84-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab583ea1-c9de-4452-b906-8e44a6af87a4/documents/IUC5-7735793e-adf4-4417-8fd2-a864b674b2c7_2fe1b774-3da9-4dcc-a3ba-e36e968e2222.html,,inhalation,LC50,> 11.24 mg/L,no adverse effect observed, Propylene carbonate,108-32-7,"Repeated dose toxicity- oral: Two reliable studies were available (Two Klimisch 2 studies). The Huntsman study (1989) is performed with a method similar to OECD guideline 408 (GLP) and was selected as the key study for this endpoint. A NOAEL above 5000 mg/kg bw/d was derived, since the oral administration of propylene carbonate (5 days a week) over a period of 90 days did no exert an apparent toxicological effect that could be related to the test substance.Repeated dose toxicity- dermal: No reliable studies were available for this route of exposure. However, no further testing is needed since reliable studies are available for repeated toxicity via the oral and inhalatory route (REACH regulation, Column 2 Adaptation, Annex VIII).Repeated dose toxicity- inhalation: Two reliable studies were available for the inhalation route (Two Klimisch 2 studies). The Huntsman study (1991) was a subchronic test performed similar to OECD guideline 413 (GLP) in which rats were exposed for 93 days. Repeated exposure to propylene carbonate in rats at concentrations up to 1000 mg/m3 produced only signs of minimal irritation to the eyes in rats. A NOAEC (systemic effects) of 1000 mg/m³ air was derived for both male and female rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d01122ae-fcdb-4b1e-aaa7-09b113d4dde9/documents/6a5efb70-bed0-4765-9efe-7f75e7935fff_925cdbb1-9742-41f1-983e-d31016befb8e.html,,,,,, Propylene carbonate,108-32-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d01122ae-fcdb-4b1e-aaa7-09b113d4dde9/documents/6a5efb70-bed0-4765-9efe-7f75e7935fff_925cdbb1-9742-41f1-983e-d31016befb8e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat Propylene carbonate,108-32-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d01122ae-fcdb-4b1e-aaa7-09b113d4dde9/documents/6a5efb70-bed0-4765-9efe-7f75e7935fff_925cdbb1-9742-41f1-983e-d31016befb8e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat Propylene carbonate,108-32-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d01122ae-fcdb-4b1e-aaa7-09b113d4dde9/documents/6a5efb70-bed0-4765-9efe-7f75e7935fff_925cdbb1-9742-41f1-983e-d31016befb8e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,100 mg/m3,adverse effect observed,rat Propylene carbonate,108-32-7,Acute toxicity- oral: An oral LD50 of > 5000 mg/kg bw was determined in male/female Sprague-Dawley rats 14 days after treatment with propylene carbonate according to OECD Guideline 401. As acute oral LD50 rat is approximately 32319 mg/kg propylene carbonate may be considered as practically non-toxic after a single ingestion.Acute toxicity- inhalation: No reliable studies were available for the inhalation route.Acute toxicity- dermal: A dermal LD50 of > 2000 mg/kg bw was determined male/female New Zealand White rabbits 14 days after treatment with propylene carbonate according to OECD Guideline 402.Acute toxicity- other routes: The LD50 values for single subcutaneous exposure were 15.8 mL/kg bw in mice and 11.1 mL/kg bw in rats after 72 hours of observation. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d01122ae-fcdb-4b1e-aaa7-09b113d4dde9/documents/5ae917bd-c478-456b-abc0-48fe9976a985_925cdbb1-9742-41f1-983e-d31016befb8e.html,,,,,, Propylene carbonate,108-32-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d01122ae-fcdb-4b1e-aaa7-09b113d4dde9/documents/5ae917bd-c478-456b-abc0-48fe9976a985_925cdbb1-9742-41f1-983e-d31016befb8e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Propylene carbonate,108-32-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d01122ae-fcdb-4b1e-aaa7-09b113d4dde9/documents/5ae917bd-c478-456b-abc0-48fe9976a985_925cdbb1-9742-41f1-983e-d31016befb8e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Propane-1,2-diol",57-55-6,"Repeated dose studies are available by oral, inhalation and dermal routes of exposure with minimal effects observed.  ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f17aae3-d7ea-4b56-ad89-2ff8e5990511/documents/IUC5-0fe0e128-a864-401a-bd0e-7cb6622f9f4b_5c342b85-b974-4b9a-8e31-c1f94cb39525.html,,,,,, "Propane-1,2-diol",57-55-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f17aae3-d7ea-4b56-ad89-2ff8e5990511/documents/IUC5-0fe0e128-a864-401a-bd0e-7cb6622f9f4b_5c342b85-b974-4b9a-8e31-c1f94cb39525.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat "Propane-1,2-diol",57-55-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f17aae3-d7ea-4b56-ad89-2ff8e5990511/documents/IUC5-0fe0e128-a864-401a-bd0e-7cb6622f9f4b_5c342b85-b974-4b9a-8e31-c1f94cb39525.html,Repeated dose toxicity – local effects,inhalation,LOAEC,160 mg/m3,adverse effect observed,rat "Propane-1,2-diol",57-55-6,"Acute data is available for oral, inhalation and dermal exposure indicating no effects at limit concentrations.  ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f17aae3-d7ea-4b56-ad89-2ff8e5990511/documents/IUC5-a36b0caf-b877-42bd-8521-95ba1f7bcc21_5c342b85-b974-4b9a-8e31-c1f94cb39525.html,,,,,, "Propane-1,2-diol",57-55-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f17aae3-d7ea-4b56-ad89-2ff8e5990511/documents/IUC5-a36b0caf-b877-42bd-8521-95ba1f7bcc21_5c342b85-b974-4b9a-8e31-c1f94cb39525.html,,oral,LD50,"22,000 mg/kg bw",, 1-butoxypropan-2-ol,5131-66-8,For repeated dose toxicity of PnB studies via all routes of exposure are available.Oral: 14-day oral gavage and 13-week d.w. studies in rats.Dermal: 13-week dermal study in rats.Inhalation: two 2-week and one 31-day whole body inhalation studies in rats. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b40250cd-754e-4cb6-a37e-68903322becf/documents/IUC5-9976a816-f230-450c-8ed1-a69825521b71_c02072b2-7784-4794-b526-84b035fd7a71.html,,,,,, 1-butoxypropan-2-ol,5131-66-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b40250cd-754e-4cb6-a37e-68903322becf/documents/IUC5-9976a816-f230-450c-8ed1-a69825521b71_c02072b2-7784-4794-b526-84b035fd7a71.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"3,244 mg/m3",,rat 1-butoxypropan-2-ol,5131-66-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b40250cd-754e-4cb6-a37e-68903322becf/documents/IUC5-9976a816-f230-450c-8ed1-a69825521b71_c02072b2-7784-4794-b526-84b035fd7a71.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,350 mg/kg bw/day,,rat 1-butoxypropan-2-ol,5131-66-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b40250cd-754e-4cb6-a37e-68903322becf/documents/IUC5-9976a816-f230-450c-8ed1-a69825521b71_c02072b2-7784-4794-b526-84b035fd7a71.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,880 mg/kg bw/day,,rat 1-butoxypropan-2-ol,5131-66-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b40250cd-754e-4cb6-a37e-68903322becf/documents/IUC5-9976a816-f230-450c-8ed1-a69825521b71_c02072b2-7784-4794-b526-84b035fd7a71.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"3,244 mg/m3",no adverse effect observed,rat 1-butoxypropan-2-ol,5131-66-8,"GLP-studies according to OECD guidelines 401, 403 and 402 (limit test) are available for PnB. Those key studies are supported by several non-GLP studies similar to the OECD guidelines. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b40250cd-754e-4cb6-a37e-68903322becf/documents/IUC5-6749f591-4e0a-4358-9b54-fdf0249c2e29_c02072b2-7784-4794-b526-84b035fd7a71.html,,,,,, 1-butoxypropan-2-ol,5131-66-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b40250cd-754e-4cb6-a37e-68903322becf/documents/IUC5-6749f591-4e0a-4358-9b54-fdf0249c2e29_c02072b2-7784-4794-b526-84b035fd7a71.html,,oral,LD50,"3,300 mg/kg bw",adverse effect observed, "Propane-1,2-diyl dibenzoate",19224-26-1," Key short-term and supporting sub-chronic oral repeat dose toxicity data is available for propylene glycol dibenzoate (PGDB). This data is supported by relevant sub-chronic repeat dose toxicity information available from a structural analogue Dipropylene glycol dibenzoate (DPGDB). The justification for read across is presented as an attachment included in Section 13 of the IUCLID dossier. PGDB OECD 422 (Rat): NOAEL = 300 mg/Kg bw/day, based on the myofibre degeneration/necrosis observed in the skeletal muscle at 1000 mg/Kg bw/day. DPGDB OECD 408 (Rat): NOAEL = 1000 mg/Kg bw/day, based on changes in blood parameters, minor treatment related pathology, and/or adverse effects on bodyweight gain observed in animals dosed at 1750 or 2500 mg/Kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08666b41-c0fe-46e4-a66f-8a260bdca857/documents/987c9e18-4a8a-459e-b6fa-7b33b68a6631_a584d5ae-9540-453e-9899-bfe504125f2e.html,,,,,, "Propane-1,2-diyl dibenzoate",19224-26-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08666b41-c0fe-46e4-a66f-8a260bdca857/documents/987c9e18-4a8a-459e-b6fa-7b33b68a6631_a584d5ae-9540-453e-9899-bfe504125f2e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Propane-1,2-diyl dibenzoate",19224-26-1, Key data is available for propylene glycol dibenzoate (PGDB). This data is supported by relevant information available from a structural analogue Dipropylene glycol dibenzoate (DPGDB). The justification for read across is provided as an attachment included in Section 13 of the IUCLID dossier. Acute oral LD50 (Rat): 4571 mg/Kg (males) and 2661 mg/Kg (females) Acute inhalation LC50 (Rat): >5.32 mg/L (4-hour) Acute dermal LD50 (Rat): >2000 mg/Kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08666b41-c0fe-46e4-a66f-8a260bdca857/documents/03cd0b20-ad1d-4997-ba84-ff10f3c47037_a584d5ae-9540-453e-9899-bfe504125f2e.html,,,,,, "Propane-1,2-diyl dibenzoate",19224-26-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08666b41-c0fe-46e4-a66f-8a260bdca857/documents/03cd0b20-ad1d-4997-ba84-ff10f3c47037_a584d5ae-9540-453e-9899-bfe504125f2e.html,,oral,LD50,"2,661 mg/kg bw",adverse effect observed, "Propane-1,2-diyl dibenzoate",19224-26-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08666b41-c0fe-46e4-a66f-8a260bdca857/documents/03cd0b20-ad1d-4997-ba84-ff10f3c47037_a584d5ae-9540-453e-9899-bfe504125f2e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Propane-1,2-diyl dibenzoate",19224-26-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08666b41-c0fe-46e4-a66f-8a260bdca857/documents/03cd0b20-ad1d-4997-ba84-ff10f3c47037_a584d5ae-9540-453e-9899-bfe504125f2e.html,,inhalation,LC50,"5,320 mg/m3",adverse effect observed, "Decanoic acid, mixed diesters with octanoic acid and propylene glycol",68583-51-7," Repeated dose toxicity: Oral NOAEL (rat, m/f): 1000 mg/kg bw/day (OECD 408, GLP)   The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be67ba16-d4f1-4935-8d4d-2e925363a144/documents/IUC5-de7c69aa-5cd7-411e-b323-43e8c6b54df7_26b261cb-f058-40b0-a440-e7179f236057.html,,,,,, "Decanoic acid, mixed diesters with octanoic acid and propylene glycol",68583-51-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be67ba16-d4f1-4935-8d4d-2e925363a144/documents/IUC5-de7c69aa-5cd7-411e-b323-43e8c6b54df7_26b261cb-f058-40b0-a440-e7179f236057.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Decanoic acid, mixed diesters with octanoic acid and propylene glycol",68583-51-7," Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (EU Method B.1) Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, GLP, category approach) Acute toxicity: Inhalation LC50 (rat, m/f): > 2.916 mg/L air (OECD 403, category approach)   The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be67ba16-d4f1-4935-8d4d-2e925363a144/documents/IUC5-116c79db-da16-4aea-bdaf-254b01286650_26b261cb-f058-40b0-a440-e7179f236057.html,,,,,, "Decanoic acid, mixed diesters with octanoic acid and propylene glycol",68583-51-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be67ba16-d4f1-4935-8d4d-2e925363a144/documents/IUC5-116c79db-da16-4aea-bdaf-254b01286650_26b261cb-f058-40b0-a440-e7179f236057.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Decanoic acid, mixed diesters with octanoic acid and propylene glycol",68583-51-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be67ba16-d4f1-4935-8d4d-2e925363a144/documents/IUC5-116c79db-da16-4aea-bdaf-254b01286650_26b261cb-f058-40b0-a440-e7179f236057.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Decanoic acid, mixed diesters with octanoic acid and propylene glycol",68583-51-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be67ba16-d4f1-4935-8d4d-2e925363a144/documents/IUC5-116c79db-da16-4aea-bdaf-254b01286650_26b261cb-f058-40b0-a440-e7179f236057.html,,inhalation,LC50,> 2.916 mg/L,no adverse effect observed, Propylene dinonanoate,41395-83-9," Oral (Read-across, OECD 407, rat) NOAEL: ≥ 2500 mg/kg bw/day The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ed32515-0771-44db-802c-f1282403f2ac/documents/47714451-e44c-4d0a-9fdc-38d12e6fc343_d3a2503c-2581-43c4-8cb2-96fcf6527cb9.html,,,,,, Propylene dinonanoate,41395-83-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ed32515-0771-44db-802c-f1282403f2ac/documents/47714451-e44c-4d0a-9fdc-38d12e6fc343_d3a2503c-2581-43c4-8cb2-96fcf6527cb9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,500 mg/kg bw/day",,rat Propylene dinonanoate,41395-83-9," Oral (similar to OECD 401): LD50 rat, mouse > 5000 mg/kg bw The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ed32515-0771-44db-802c-f1282403f2ac/documents/bcceeb1f-0a98-40ba-88d9-178d3656423d_d3a2503c-2581-43c4-8cb2-96fcf6527cb9.html,,,,,, Propylene dinonanoate,41395-83-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ed32515-0771-44db-802c-f1282403f2ac/documents/bcceeb1f-0a98-40ba-88d9-178d3656423d_d3a2503c-2581-43c4-8cb2-96fcf6527cb9.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "Isooctadecanoic acid, monoester with propane-1,2-diol",68171-38-0," Oral (read across, OECD 408, rat) NOAEL: ≥1000 mg/kg bw/day The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a460fe31-596f-43ed-84f9-d70e5704a5ae/documents/24aa6bce-d700-41e3-92aa-83d35401ce49_8e5a9cff-0d72-42e2-9c73-1720d05b163f.html,,,,,, "Isooctadecanoic acid, monoester with propane-1,2-diol",68171-38-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a460fe31-596f-43ed-84f9-d70e5704a5ae/documents/24aa6bce-d700-41e3-92aa-83d35401ce49_8e5a9cff-0d72-42e2-9c73-1720d05b163f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Isooctadecanoic acid, monoester with propane-1,2-diol",68171-38-0," Oral (OECD 401) rat, m/f: LD50 > 2000 mg/kg bw Dermal (read across, OECD 402) rat, m/f: LD50 > 2000 mg/kg bw The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the glycol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a460fe31-596f-43ed-84f9-d70e5704a5ae/documents/e4f315a9-d817-43bd-b3ff-c2d3fa5eca28_8e5a9cff-0d72-42e2-9c73-1720d05b163f.html,,,,,, "Isooctadecanoic acid, monoester with propane-1,2-diol",68171-38-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a460fe31-596f-43ed-84f9-d70e5704a5ae/documents/e4f315a9-d817-43bd-b3ff-c2d3fa5eca28_8e5a9cff-0d72-42e2-9c73-1720d05b163f.html,,oral,LD50,">=2,000 mg/kg bw",no adverse effect observed, "Isooctadecanoic acid, monoester with propane-1,2-diol",68171-38-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a460fe31-596f-43ed-84f9-d70e5704a5ae/documents/e4f315a9-d817-43bd-b3ff-c2d3fa5eca28_8e5a9cff-0d72-42e2-9c73-1720d05b163f.html,,dermal,LD50,">=2,000 mg/kg bw",no adverse effect observed, "Lauric acid, monoester with propane-1,2-diol",27194-74-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) conducted in 2015 with no deficiencies and assigned Klimisch 1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4b685d4-21e1-499f-8e8c-6cdc848ff0d9/documents/6a4605ec-c841-4fb6-bedf-93a229478991_4a782a4a-bb85-4e01-b4e8-ec8d8933d088.html,,,,,, "Lauric acid, monoester with propane-1,2-diol",27194-74-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4b685d4-21e1-499f-8e8c-6cdc848ff0d9/documents/6a4605ec-c841-4fb6-bedf-93a229478991_4a782a4a-bb85-4e01-b4e8-ec8d8933d088.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Lauric acid, monoester with propane-1,2-diol",27194-74-7, Acute toxicity: Oral LD50 > 2000 mg/kg bodyweight Acute toxicity: Dermal LD50 > 2000 mg/kg bodyweight ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4b685d4-21e1-499f-8e8c-6cdc848ff0d9/documents/71b90b97-e515-4c94-bc8e-a7be596b4938_4a782a4a-bb85-4e01-b4e8-ec8d8933d088.html,,,,,, "Dodecanoic acid, ester with 1,2-propanediol",37321-62-3,Oral (subacute): NOAEL (systemic toxicity) ≥ 1000 mg/kg bw/day Read-across based on grouping of substances (category approach) considering all available data on subacute and subchronic repeated dose toxicity in the propylene glycol esters category in a weight of evidence approach. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2e2e99f-b63a-49b9-950f-1d200b52a8ac/documents/baeb1285-80e0-4f7f-a09c-0e16536f69f7_07f71897-d567-4e10-9967-b8aa23677b7b.html,,,,,, "Dodecanoic acid, ester with 1,2-propanediol",37321-62-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2e2e99f-b63a-49b9-950f-1d200b52a8ac/documents/baeb1285-80e0-4f7f-a09c-0e16536f69f7_07f71897-d567-4e10-9967-b8aa23677b7b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat "Dodecanoic acid, ester with 1,2-propanediol",37321-62-3,"Oral LD50 (OECD 401, GLP, rat) > 2000 mg/kg bw Conclusion based on data with dodecanoic acid, ester with 1,2-propanediol (EC 253-462-2, CAS 37321-62-3).   Inhalation No information is required according to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, as data on acute oral toxicity are provided and the oral and dermal route are considered more relevant.   Dermal No information is required according to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5.2, Column 2, as the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure performed with propylene glycol category substances. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2e2e99f-b63a-49b9-950f-1d200b52a8ac/documents/2ac449f0-8962-4666-854d-0436d25cc473_07f71897-d567-4e10-9967-b8aa23677b7b.html,,,,,, "Dodecanoic acid, ester with 1,2-propanediol",37321-62-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2e2e99f-b63a-49b9-950f-1d200b52a8ac/documents/2ac449f0-8962-4666-854d-0436d25cc473_07f71897-d567-4e10-9967-b8aa23677b7b.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 1-propoxypropan-2-ol,1569-01-3,A GLP-study according to OECD guideline 413 and several GLP-studies according to or equivalent to OECD guideline 412 are available for propylene glycol n-propyl ether. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1632bb4-bd9e-43d7-91a2-5b53dfcce975/documents/IUC5-99dbf20b-026e-4088-8320-ffd3eb023737_c230b7d8-b74b-40f2-bd4f-1adf51c7856a.html,,,,,, 1-propoxypropan-2-ol,1569-01-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1632bb4-bd9e-43d7-91a2-5b53dfcce975/documents/IUC5-99dbf20b-026e-4088-8320-ffd3eb023737_c230b7d8-b74b-40f2-bd4f-1adf51c7856a.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,474 mg/m3",,rat 1-propoxypropan-2-ol,1569-01-3,"Several non-GLP studies equivalent to OECD guidelines 401, 402 and 403 are available for propylene glycol n-propyl ether. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1632bb4-bd9e-43d7-91a2-5b53dfcce975/documents/IUC5-96d21023-eaf3-4840-b315-83e2831959a6_c230b7d8-b74b-40f2-bd4f-1adf51c7856a.html,,,,,, 1-propoxypropan-2-ol,1569-01-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1632bb4-bd9e-43d7-91a2-5b53dfcce975/documents/IUC5-96d21023-eaf3-4840-b315-83e2831959a6_c230b7d8-b74b-40f2-bd4f-1adf51c7856a.html,,oral,LD50,"2,490 mg/kg bw",adverse effect observed, 1-propoxypropan-2-ol,1569-01-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1632bb4-bd9e-43d7-91a2-5b53dfcce975/documents/IUC5-96d21023-eaf3-4840-b315-83e2831959a6_c230b7d8-b74b-40f2-bd4f-1adf51c7856a.html,,dermal,LD50,"3,775 mg/kg bw",adverse effect observed, "Stearic acid, monoester with propane-1,2-diol",1323-39-3,"Stearic acid, monoester with propane-1,2-diol (PGMS) is a UVCB substance. The two main constituents of the UVCB substance are the monoester of propane-diol with octadecanoic acid (45-98%) and the monoester of propane-diol with palmitic acid (2-50%).   Metabolism studies of propane-1,2-diol esters of stearate show that the substances are partially hydrolysed by pancreatic lipase; approx. 70% in 15 h. As the passage through the small intestine has a duration of 6–8 h, unhydrolyzed propane-1,2-diol esters of stearate will be present in the gastrointestinal tract for absorption (EFSA 2018a).   The possible repeated dose toxicity of this substance is therefore assessed in the present weight of evidence analysis based on existing data on propane-1,2-diol esters of fatty acids including PGMS (EFSA 2018a) and the relevant hydrolysis products propane-1,2-diol (EFSA 2018b) and fatty propylene glycol stearate (PGS) and glycerol stearate (CIR 2015; 2016).   Three studies on PGMS are reported for repeated dose toxicity. Two 90-day studies in rats exposed to PGMS via the diet at concentrations up to 6768 mg PGMS /kg bw per day was conducted. Animals were examined for differences in organ weights, gross and microscopic pathology, haematology and urinalysis. No clinical symptoms or treatment related effects were found. The NOAEL based on these studies is therefore the highest dose tested; ≥ 6768 mg/kg bw/day (EFSA 2018).   No treatment-related effects were detected in the Beagle dog exposed for 6 months via the diet containing up to 432 mg PGMS/kg bw/day (King et al., 1971 in EFSA 2018). Supportive of this, no evidence of oral or dermal toxicity was found in subchronic studies of animals exposed to propylene glycol monostearate in rats and dogs (CIR 2015). No toxicity was reported in subchronic and chronic dermal toxicity tests, 4-5% GS in rabbits, other than local effects of moderate irritation (CIR 2016).   Further, it is noted that PGS and GS is considered Generally Recognized as Safe (GRAS) for food use (CIR 2015; 2016).   Also, data on propane 1,2-diol did not show any adverse effects of propane 1,2-diol, for which an ADI of 25 mg/kg bw/day could be established by EFSA (2018b).   Based on the available studies on PGMS and the propylene glycol esters described above, it can from an overall weight of evidence approach be concluded that the UVCB substance PGMS is of very low concern for repeated dose toxicity. It can with a high degree of confidence be concluded that an assumed NOAEL for PGMS is far above 1000 mg/kg bw/day, which is normally considered as the highest relevant dose level when testing for repeated dose toxicity.   Overall, the available information comprises adequate, reliable studies from reference substances with similar structure and intrinsic properties. Weight-of-evidence is justified based on common functional group and common precursors/breakdown products. The information from these independent sources is consistent and provides sufficient weight of evidence leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/280a279a-0fe8-4715-a535-4875f32872bf/documents/37f1fb27-12ae-4ff0-ad80-9022b0fca4fc_ed099641-4603-433e-a46e-817cddb701fb.html,,,,,, "Stearic acid, monoester with propane-1,2-diol",1323-39-3," Based on the studies available for Stearic acid, monoester with propane-1,2-diol (PGMS) and the relevant hydrolysis products and the components of the UVCB substance, it can with a high degree of confidence be concluded that an assumed acute oral lethal dose 50 (LD50) for PGMS is above 10000 mg/kg, and well above 5000 mg/kg which is normally considered as the highest relevant dose level when testing acute toxicity. Based on the studies available for Stearic acid, monoester with propane-1,2-diol (PGMS) and the relevant hydrolysis products and the components of the UVCB substance, it can with a high degree of confidence be concluded that an assumed acute dermal lethal dose 50 (LD50) for PGMS is above 2000 mg/kg. Thus, PGMS is not to be classified for acute oral and dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/280a279a-0fe8-4715-a535-4875f32872bf/documents/92ba3520-2a16-486d-90bb-2ee11713b796_ed099641-4603-433e-a46e-817cddb701fb.html,,,,,, "Stearic acid, monoester with propane-1,2-diol",1323-39-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/280a279a-0fe8-4715-a535-4875f32872bf/documents/92ba3520-2a16-486d-90bb-2ee11713b796_ed099641-4603-433e-a46e-817cddb701fb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Stearic acid, monoester with propane-1,2-diol",1323-39-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/280a279a-0fe8-4715-a535-4875f32872bf/documents/92ba3520-2a16-486d-90bb-2ee11713b796_ed099641-4603-433e-a46e-817cddb701fb.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Propylenediamine,78-90-0,"Inhalation: 28-day study: rat, OECD 412, under GLP, NOAEC systemic = 100 mg/m3, NOAEC local = 5 mg/m3, K1 5-day study: rat, similar to OECD 412, under GLP, NOAEC systemic = 1000 mg/m3, LOAEC local = 100 mg/m3, K1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34b3e23d-8653-466c-83bd-15ee5ff90397/documents/f3859991-7465-49a4-8d0b-ad9da08b7dbc_e637a86e-dbff-4c6d-a1c1-05ffb6c448d7.html,,,,,, Propylenediamine,78-90-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34b3e23d-8653-466c-83bd-15ee5ff90397/documents/f3859991-7465-49a4-8d0b-ad9da08b7dbc_e637a86e-dbff-4c6d-a1c1-05ffb6c448d7.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,100 mg/m3,,rat Propylenediamine,78-90-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34b3e23d-8653-466c-83bd-15ee5ff90397/documents/f3859991-7465-49a4-8d0b-ad9da08b7dbc_e637a86e-dbff-4c6d-a1c1-05ffb6c448d7.html,Repeated dose toxicity – local effects,inhalation,NOAEC,5 mg/m3,adverse effect observed,rat Propylenediamine,78-90-0,"Acute toxicity - oral: standard acute method, rat, similar to OECD 401, non-GLP, LD50 = 1300 mg/kg bw, K2 - dermal: method similar to Draize test, rabbit, non-GLP, LD50 = 430 mg/kg bw, K2 - inhalative: BASF-test, rat, non-GLP, discriminating conc. = 49000 mg/m3, K2 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34b3e23d-8653-466c-83bd-15ee5ff90397/documents/b4ac05d9-592f-488e-965b-400d1d6516da_e637a86e-dbff-4c6d-a1c1-05ffb6c448d7.html,,,,,, Propylenediamine,78-90-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34b3e23d-8653-466c-83bd-15ee5ff90397/documents/b4ac05d9-592f-488e-965b-400d1d6516da_e637a86e-dbff-4c6d-a1c1-05ffb6c448d7.html,,oral,LD50,"1,300 mg/kg bw",adverse effect observed, Propylenediamine,78-90-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34b3e23d-8653-466c-83bd-15ee5ff90397/documents/b4ac05d9-592f-488e-965b-400d1d6516da_e637a86e-dbff-4c6d-a1c1-05ffb6c448d7.html,,dermal,LD50,430 mg/kg bw,adverse effect observed, Propylenediamine,78-90-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34b3e23d-8653-466c-83bd-15ee5ff90397/documents/b4ac05d9-592f-488e-965b-400d1d6516da_e637a86e-dbff-4c6d-a1c1-05ffb6c448d7.html,,inhalation,discriminating conc.,"49,000 mg/m3",adverse effect observed, Propyl 4-hydroxybenzoate,94-13-3, Based on an OECD-conform 90 days repated dose oral toxicity study in rats (OECD 408): NOAEL (male/female rat): 1000 mg/kg bw/d ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab316805-a6af-4b0f-abe6-cee9683d2e50/documents/74c63bb0-db59-45bd-b1e5-18cc7d54dd4e_ddc67a11-4875-4139-a1ef-926c2ac442fa.html,,,,,, Propyl 4-hydroxybenzoate,94-13-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab316805-a6af-4b0f-abe6-cee9683d2e50/documents/74c63bb0-db59-45bd-b1e5-18cc7d54dd4e_ddc67a11-4875-4139-a1ef-926c2ac442fa.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Propyl 4-hydroxybenzoate,94-13-3,"rat, oral (OECD 401): LD50 > 5000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab316805-a6af-4b0f-abe6-cee9683d2e50/documents/e3b36c9c-8545-437c-8c2b-6bf55155cf13_ddc67a11-4875-4139-a1ef-926c2ac442fa.html,,,,,, Propyl 4-hydroxybenzoate,94-13-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab316805-a6af-4b0f-abe6-cee9683d2e50/documents/e3b36c9c-8545-437c-8c2b-6bf55155cf13_ddc67a11-4875-4139-a1ef-926c2ac442fa.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,4-dihydroxybenzaldehyde",139-85-5,"Acute oral toxicity: Key study. Test method according to OECD 423, GLP study. The LD50 of the test item is higher than 300 mg/kg and lower than 2000 mg/ kg body weight by oral route in the rat. Therefore test item has to be classified in Category 4 in accordance with the Regulation EC No. 1272/2008. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Key study with Klimisch score = 1 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31dcfe09-6a74-4a55-b767-f5960c31b178/documents/13c31ea4-d7da-42a0-8532-d2ae0d572189_40924fe5-9dad-4fec-95f2-0aaa7bfeba9e.html,,,,,, "3,4-dihydroxybenzaldehyde",139-85-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31dcfe09-6a74-4a55-b767-f5960c31b178/documents/13c31ea4-d7da-42a0-8532-d2ae0d572189_40924fe5-9dad-4fec-95f2-0aaa7bfeba9e.html,,oral,LD50,>=300 mg/kg bw,adverse effect observed, Pyridoxine hydrochloride,58-56-0,Company data and peer-reviewed literature do not indicate oral and dermal toxicity of pyridoxine-hydrochloride below 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/695aeb18-0b8f-435d-b502-b79593d8fba3/documents/418c6ca9-7e8b-4871-be34-766d0b929ddf_20747891-3ffd-480e-8d8e-1d94c1eee1b1.html,,,,,, Pyridoxine hydrochloride,58-56-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/695aeb18-0b8f-435d-b502-b79593d8fba3/documents/418c6ca9-7e8b-4871-be34-766d0b929ddf_20747891-3ffd-480e-8d8e-1d94c1eee1b1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Pyrocatechol,120-80-9," One study has been choosen has a key study, the OECD 422 study performed in 2009. Reduction of body weught and local effect were observed based on this study. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7ac69b2-e633-4c5b-bbad-3f2f606c21d9/documents/IUC5-7d5eb072-eda9-4e82-b1ab-12844c2f8c75_75bd2c95-8adf-4f4f-8515-45be0df70c81.html,,,,,, Pyrocatechol,120-80-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7ac69b2-e633-4c5b-bbad-3f2f606c21d9/documents/IUC5-7d5eb072-eda9-4e82-b1ab-12844c2f8c75_75bd2c95-8adf-4f4f-8515-45be0df70c81.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat Pyrocatechol,120-80-9,LD50 oral (rat): 300 mg/kgLC0 inhalation (8h)(rat) > 2.8 mg/LLD50 dermal (rat): 600 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7ac69b2-e633-4c5b-bbad-3f2f606c21d9/documents/IUC5-67b2b459-a50a-443d-8616-89694736db4b_75bd2c95-8adf-4f4f-8515-45be0df70c81.html,,,,,, Pyrocatechol,120-80-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7ac69b2-e633-4c5b-bbad-3f2f606c21d9/documents/IUC5-67b2b459-a50a-443d-8616-89694736db4b_75bd2c95-8adf-4f4f-8515-45be0df70c81.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Pyrocatechol,120-80-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7ac69b2-e633-4c5b-bbad-3f2f606c21d9/documents/IUC5-67b2b459-a50a-443d-8616-89694736db4b_75bd2c95-8adf-4f4f-8515-45be0df70c81.html,,dermal,LD50,600 mg/kg bw,adverse effect observed, 3-(D-gluconoylamino)propyl(2-hydroxyethyl)dimethylammonium chloride,51812-80-7, Key information is based on a classic in-vivo oral single dose study in rats with multiple doses of CERAPHYL® 60 (6% solids) ranging from 2 to 64 ml per kg. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83592551-c005-4af7-b9c3-ea49bccb8e29/documents/17a2dbc1-9a87-46db-82f6-7eb95c9e4488_42da01cf-8c4d-4823-98d4-830d163b9f07.html,,,,,, 3-(D-gluconoylamino)propyl(2-hydroxyethyl)dimethylammonium chloride,51812-80-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83592551-c005-4af7-b9c3-ea49bccb8e29/documents/17a2dbc1-9a87-46db-82f6-7eb95c9e4488_42da01cf-8c4d-4823-98d4-830d163b9f07.html,,oral,LD50,"3,840 mg/kg bw",no adverse effect observed, "1-Propanaminium, 3-amino-N-(2-hydroxyethyl)-N,N-dimethyl-, N-mink-oil acyl derivs., chlorides",68953-64-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): In-vivo studies with Ceraphyl 65 showed that the LD50 > 360 and < 3000 mg/kg for the substance under registration. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c913cc2-8afa-4e6a-92e9-ae4d9fd01406/documents/cd5ebe9a-2cbf-4e2f-9f23-db722892d96d_ce39a39f-81e7-482d-ab1b-ed9f6310786d.html,,,,,, "1-Propanaminium, 3-amino-N-ethyl-N,N-dimethyl-, N-lanolin acyl derivs., Et sulfates",72102-40-0," Based on the results of the read across study, the oral LD50 value of the test substance, 'iso and anteiso C10-40 AAP EDM-ES' was considered to be >2350 mg/kg bw, indicating low acute toxicity potential. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c60c0da-b11f-4eaa-8ed3-e5b9f4b7dafe/documents/25540fa2-179d-42ff-b98d-0da24ad817e9_d29131d1-fc36-4f18-a9fe-f320d8cfd1c4.html,,,,,, "1-Propanaminium, 3-amino-N-ethyl-N,N-dimethyl-, N-lanolin acyl derivs., Et sulfates",72102-40-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c60c0da-b11f-4eaa-8ed3-e5b9f4b7dafe/documents/25540fa2-179d-42ff-b98d-0da24ad817e9_d29131d1-fc36-4f18-a9fe-f320d8cfd1c4.html,,oral,LD50,"2,350 mg/kg bw",no adverse effect observed, Dimethyl[3-[(1-oxooctadecyl)amino]propyl][2-oxo-2-(tetradecyloxy)ethyl]ammonium chloride,68921-83-5, The key value is based on an in-vivo study from pre-GLP period. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e064df8a-673e-41f2-bff4-1d9bbff36734/documents/8da4cb58-5305-4d88-95d4-00e075b7b69d_3c5259cd-1c02-4d70-8744-2366a4c686a1.html,,,,,, Dimethyl[3-[(1-oxooctadecyl)amino]propyl][2-oxo-2-(tetradecyloxy)ethyl]ammonium chloride,68921-83-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e064df8a-673e-41f2-bff4-1d9bbff36734/documents/8da4cb58-5305-4d88-95d4-00e075b7b69d_3c5259cd-1c02-4d70-8744-2366a4c686a1.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Imidazolium compounds, 2-(C9-19 and C9-19-unsatd. alkyl)-1-[(C10-20 and C10-20-unsatd. amido)ethyl]-4,5-dihydro-1-Me, Me sulfates",92201-88-2," Based on the results of the read across study, test substance, 'di-C16 and C18-unsatd. AAEMIM-MS' is considered to be of low acute oral toxicity, with an oral LD50 value >2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0658f61-ac3c-4ea2-8352-c24cc575976f/documents/a20c576a-1577-4d30-ae01-9d04e53de896_08b22bfc-64ca-4ea1-a5e8-be6d09d72c00.html,,,,,, "Imidazolium compounds, 2-(C9-19 and C9-19-unsatd. alkyl)-1-[(C10-20 and C10-20-unsatd. amido)ethyl]-4,5-dihydro-1-Me, Me sulfates",92201-88-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0658f61-ac3c-4ea2-8352-c24cc575976f/documents/a20c576a-1577-4d30-ae01-9d04e53de896_08b22bfc-64ca-4ea1-a5e8-be6d09d72c00.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized",97953-16-7," In a reliable subchronic toxicity study comparable to OECD guideline 408 (1981), a structurally similar substance was administered to 20 Sprague-Dawley rats/sex/dose by oral feed at dose levels of 0, 10, 100 and 1000 mg/kg bw/day (active ingredient) for 90 days. No satellite group was included to assess the reversibility of any potentially adverse effects. There were no treatment related clinical signs observed, no animal died or was sacrificed during the study. Body weights and weight gains were in a normal range. No significant differences in food consumption were detected for any treated male group. Food consumption in the 10 and 100 mg/kg bw/day female groups were significantly increased during some weeks during the study. There were no consistent differences in food efficiencies. Decreased values of absolute and relative liver weights in the male high dose group were probably treatment related and were accompanied by lower total serum protein and higher SGPT and SGOT concentrations for this treatment level. Correlating microscopic lesions were not detected. A dose dependency for these effects was not found. No other treatment related effects on organ weights, hematological or clinical chemistry parameters were observed. All macroscopic observations and microscopic lesions were considered incidental and not treatment related. Microscopic examinations revealed no treatment related changes. The histological examination of the reproductive organs (testes, epididymis, prostate, seminal vesicle, ovary, uterus and vagina) did not reveal any treatment related abnormalities. The NOEL was 100 mg/kg bw/day. The study suffers, however, from the excessively wide dose spacing, which would not be the standard for present day testing protocols. Considering the overall toxicological profile, there is no evidence for a potential serious health risk for humans upon ingestion of members of this chemical structure family. As a consequence, the reported NOEL has been recalculated for the derivation of an acceptable DNEL long term oral, departing from the highest dose as the LOAEL to arrive at a realistic basis for DNEL derivations, resulting in the recalculated NOAEL of 300 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16855d2c-b001-4420-a222-4872cfb550ee/documents/03e9763d-363a-45aa-afed-4edc629a7db6_12dee9ce-3074-4007-99cb-ea11cad0c553.html,,,,,, "9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized",97953-16-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16855d2c-b001-4420-a222-4872cfb550ee/documents/03e9763d-363a-45aa-afed-4edc629a7db6_12dee9ce-3074-4007-99cb-ea11cad0c553.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized",97953-16-7," In a reliable acute toxicity study the substance was administered to Wistar rats (5 female animals) by oral gavage at a dose level of 2000 mg/kg bw (single administration) following a sighting test with one animal at a dose of 300 mg/kg bw. There was one death 2 days after dosing and hunched posture and noisy respiration were noted during the day of dosing in the initial treated animal. Surviving animals showed expected gains in body weight, except for two animals which showed either no gain in body weight or body weight loss during the first week, but expected gain in body weight during the second week. Abnormalities noted at necropsy of the animal that died during the study were dark and patchy pallor of the liver and dark kidneys. No abnormalities were noted at necropsy of animals that were killed at the end of the study. The acute oral median lethal dose (LD50) of the substance in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw. In a reliable acute oral toxicity study test performed according to the OECD Guideline 423, 2001, 6 female HanRcc:WIST (SPF) rats were given a single oral dose of a structurally similar substance (100 % a.i.) in corn oil at doses of 2000 mg/kg bw and observed for 14 days. All animals survived until the end of the study period. No clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. Oral LD50 in Females: > 2000 mg/kg bw. In an acute oral toxicity study in accordance with US Federal Hazardous Substances Act (FHSA), groups of fasted adult male rats of the Sprague-Dawley strain were given a single oral dose of oleic-acid based IQAC, DMS quaternised (76 % solids) at doses of 5000, 10000 or 20000  mg/kg bw and observed for 14 days.  The Oral LD50Males > 20000  mg/kg bw (76% solids) In a reliable acute dermal toxicity study 5 male and 5 female young adult HanRcc: WIST(SPF) rats were dermally exposed to a structurally similar substance suspended in corn oil for 24 hours under a semi-occlusive dressing to approx. 10 % of body surface area at doses of 2000 or 200 mg/kg bw. The high dose animals were euthanized due to severe local effects after ten days. No symptoms of systemic toxicity were observed. The local skin reactions affected the study and prevented the full assessment of the LD50. However, even though the 14 day observation period could not be completed the onset of systemic toxicity should have been apparent on day 10. No mortality occurred. No clinical signs or gross pathological findings were observed. No weight gain or slight (< 1 %) weight loss was observed in three females of the high dose group (2000 mg/kg bw) and a slight (0.7 % during the first week) but reversible weight loss in one female of the low dose group (200 mg/kg bw). Dermal LD50  in Males > 2000 mg/kg bw,  Females > 2000 mg/kg bw and Combined > 2000 mg/kg bw.             ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16855d2c-b001-4420-a222-4872cfb550ee/documents/21f3ede8-6cbd-41d7-9f37-359f10162972_12dee9ce-3074-4007-99cb-ea11cad0c553.html,,,,,, "9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized",97953-16-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16855d2c-b001-4420-a222-4872cfb550ee/documents/21f3ede8-6cbd-41d7-9f37-359f10162972_12dee9ce-3074-4007-99cb-ea11cad0c553.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "9-Octadecenoic acid (Z)-, reaction products with diethylenetriamine, di-Me sulfate-quaternized",97953-16-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16855d2c-b001-4420-a222-4872cfb550ee/documents/21f3ede8-6cbd-41d7-9f37-359f10162972_12dee9ce-3074-4007-99cb-ea11cad0c553.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Quillaja saponaria, ext.",68990-67-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 4 studies with reliability of 2 are available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05285118-d294-4172-bcbf-da868b554c92/documents/IUC5-e1069527-586b-4315-a443-9caccab70034_94430312-b3f5-4d4f-b360-a0b3b223db87.html,,,,,, "Quillaja saponaria, ext.",68990-67-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05285118-d294-4172-bcbf-da868b554c92/documents/IUC5-e1069527-586b-4315-a443-9caccab70034_94430312-b3f5-4d4f-b360-a0b3b223db87.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,500 mg/kg bw/day",,rat "Quillaja saponaria, ext.",68990-67-0,"Acute oral toxicity: The acute oral toxicity of the liquid QUILLAJA EXTRACT QL AGRI, LOTE: 260208-0700 was investigated according to US EPA Guideline EPA OPPTS 870.1100. A group of 3 female Sprague Dawley rats were administered a liquid extract of Quillaja saponaria at a single dose of 5000 mg/kg bw by gavage.No mortality and no clinical signs of toxicity were obeserved. No abnormalities were recorded durcing necropsies. Therefore the acute oral LD50 value was estimated as > 5000 mg/kg bw.Acute toxicity by the inhalation route: The acute toxicity by the the inhalation route of Quillaja saponaria powder was examined according to OECD Guideline 403. A limit test with an exposition of 0.45 mg/L as a nominal concentration was performed due to the physical-chemical properties of the test substance. This was the highest technical achievable concentration. A group of 5 males and 5 females received nasal only exposure to aerosol concentrations of the test substance during 4 hours. No mortality and clinical sign of toxicity were observed. No abnormalities were recorded during necropsy. Therefore the acute LC50 value of Quillaja saponaria powder can be stated as > 0.45 mg/l.Acute dermal toxicity: The acute dermal toxicity of a liquid Quillaja saponaria extract was investigated according to US EPA Guideline EPA OPPTS 870.1200 (Acute Dermal Toxicity).The test item was applied as a single dose of 2000 mg/kg bw to the shaved dorsal area of the trunk of 5 male and 5 female Sprague Dawley rats. The coverage of the exposed area was removed after 24 hours. No mortolatity or clinical signs of toxicity was observed. No abnormalites were recorded durcing necropsy. Therefore the acute dermal LD50 was estimated as > 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05285118-d294-4172-bcbf-da868b554c92/documents/IUC5-0a75be9f-3e82-4085-af0b-216c423ca914_94430312-b3f5-4d4f-b360-a0b3b223db87.html,,,,,, "Quillaja saponaria, ext.",68990-67-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05285118-d294-4172-bcbf-da868b554c92/documents/IUC5-0a75be9f-3e82-4085-af0b-216c423ca914_94430312-b3f5-4d4f-b360-a0b3b223db87.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Quillaja saponaria, ext.",68990-67-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05285118-d294-4172-bcbf-da868b554c92/documents/IUC5-0a75be9f-3e82-4085-af0b-216c423ca914_94430312-b3f5-4d4f-b360-a0b3b223db87.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Quillaja saponaria, ext.",68990-67-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05285118-d294-4172-bcbf-da868b554c92/documents/IUC5-0a75be9f-3e82-4085-af0b-216c423ca914_94430312-b3f5-4d4f-b360-a0b3b223db87.html,,inhalation,LC50,450 mg/m3,no adverse effect observed, "1,3,4,5-tetrahydroxycyclohexanecarboxylic acid",77-95-2,The LD50 of the read across substance cyclohexanecarboxylic acid for rats is 3265 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69873add-45b0-439b-9c5a-4d5a6e227a5b/documents/IUC5-36762735-8d6a-4f78-8333-b9c9f0b4077e_342545bd-6e65-4864-becf-5fd81765c116.html,,,,,, "1,3,4,5-tetrahydroxycyclohexanecarboxylic acid",77-95-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69873add-45b0-439b-9c5a-4d5a6e227a5b/documents/IUC5-36762735-8d6a-4f78-8333-b9c9f0b4077e_342545bd-6e65-4864-becf-5fd81765c116.html,,oral,LD50,"3,265 mg/kg bw",no adverse effect observed, Quinine,130-95-0,For quinine hydrochloride a no effect level of 60 mg/kg per day was defined. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ecffdec-96b6-4232-b927-101d73621ee7/documents/IUC5-a68cf304-ba37-403b-8749-0e41e5a7bdb5_17efcba9-6676-4f94-8cf5-a4aed1e513ca.html,,,,,, Quinine,130-95-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ecffdec-96b6-4232-b927-101d73621ee7/documents/IUC5-a68cf304-ba37-403b-8749-0e41e5a7bdb5_17efcba9-6676-4f94-8cf5-a4aed1e513ca.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat Quinine,130-95-0,The LD50 of quinine for rats after oral application is 350.82 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ecffdec-96b6-4232-b927-101d73621ee7/documents/IUC5-3926aa0a-e5bf-4c0e-896f-90db46623f29_17efcba9-6676-4f94-8cf5-a4aed1e513ca.html,,,,,, Quinine,130-95-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ecffdec-96b6-4232-b927-101d73621ee7/documents/IUC5-3926aa0a-e5bf-4c0e-896f-90db46623f29_17efcba9-6676-4f94-8cf5-a4aed1e513ca.html,,oral,LD50,350.82 mg/kg bw,adverse effect observed, "1-Propanaminium, 3-amino-N-ethyl-N,N-dimethyl-, N-rape-oil acyl derivs., Et sulfates",94552-41-7," Based on the results the read across study, the oral LD50 value of the test substance, 'C18-unsatd and C22-unsatd. AAP EDM-ES' is considered to be > 2350 mg a.i./kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fabfa07-4543-4160-9c53-2bef00fd1afc/documents/fc9f07ba-1ab1-479c-93d8-56185a53aa5b_51398943-bbae-494a-b9a5-905d4446cd2a.html,,,,,, "1-Propanaminium, 3-amino-N-ethyl-N,N-dimethyl-, N-rape-oil acyl derivs., Et sulfates",94552-41-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fabfa07-4543-4160-9c53-2bef00fd1afc/documents/fc9f07ba-1ab1-479c-93d8-56185a53aa5b_51398943-bbae-494a-b9a5-905d4446cd2a.html,,oral,LD50,"2,350 mg/kg bw",no adverse effect observed, 4-(4-hydroxyphenyl)butan-2-one,5471-51-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Food and Cosmetics Toxicology. Vol. 8, Pg. 349, 1970. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2b90391-affa-47a6-b982-b7e6c143cf71/documents/980325e5-e15f-403f-ad21-cdea588fd691_a763f5f3-3a52-42c7-9b4a-82916bbfec64.html,,,,,, 4-(4-hydroxyphenyl)butan-2-one,5471-51-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2b90391-affa-47a6-b982-b7e6c143cf71/documents/980325e5-e15f-403f-ad21-cdea588fd691_a763f5f3-3a52-42c7-9b4a-82916bbfec64.html,,oral,LD50,"1,320 mg/kg bw",, "resorcinol; 1,3-benzenediol",108-46-3,"The following information is taken into account for any hazard / risk assessment:   Repeated dose toxicity (oral): In multiple repeat dose studies, the lowest no adverse effect level (NOAEL) associated with a reproducible effect (body weight changes) is 80 mg/kg bw/day. NOAELs associated with the NTP studies are based on CNS effects as requested under the Organization of Economic Cooperation and Development (OECD) Screening Information Data Set (SIDS) Program, whilst the NTP review panel regarded these effects as acute effects and were considered a result of bolus dosing. Repeated dose toxicity (inhalation): In a 14-day range finding study, no adverse effect concentration (NOAEC) is 991 mg/m3. There are no findings suggestive of local effects on respiratory tract. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Range-finding study. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The oral database is of a good/standard quality. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8cb3935-4691-4d93-a91f-ade42d6a6b0e/documents/IUC5-4340239c-7e0e-4ef5-85fb-a48c74739203_2c93b7c9-0be7-40ee-bd05-beacfe72d62e.html,,,,,, "resorcinol; 1,3-benzenediol",108-46-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8cb3935-4691-4d93-a91f-ade42d6a6b0e/documents/IUC5-4340239c-7e0e-4ef5-85fb-a48c74739203_2c93b7c9-0be7-40ee-bd05-beacfe72d62e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat "resorcinol; 1,3-benzenediol",108-46-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8cb3935-4691-4d93-a91f-ade42d6a6b0e/documents/IUC5-4340239c-7e0e-4ef5-85fb-a48c74739203_2c93b7c9-0be7-40ee-bd05-beacfe72d62e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,991 mg/m3,no adverse effect observed,rat "resorcinol; 1,3-benzenediol",108-46-3,"Following OECD TG 401, the acute oral LD50 of resorcinol in rats is 510 mg/kg bw. Clinical signs of toxicity included ptosis, respiratory effects, lethargy, abnormal gait, tremors, convulsions and salivation. An additional acute oral toxicity study in rats resulted in an LD50 of 980 mg/kg bw. Hyperemia and distention of stomach and intestines were observed in the animals that died during the observation period. Using the fixed dose procedure, another study determined the maximum non-lethal dose of resorcinol to be 200 mg/kg in rats. At this dose, CNS effects were observed on day 1 following treatment, with complete recovery by day 2. In rats exposed by inhalation to an aerosol of resorcinol, the 1 hr and 8 hr LC0 values were >= 7800 mg/m3 and 2800 mg/m3, respectively. No lesions attributable to inhalation of the aerosol were seen at gross necropsy. The rabbit 24 hour dermal LD50 was 3360 and 2830 mg/kg bw for flaked and industrial grade resorcinol, respectively. Both grades produced necrosis of the skin; reported clinical signs included salivation, tremors, and convulsions prior to death. The overt CNS effects were considered to be associated with bolus dosing. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8cb3935-4691-4d93-a91f-ade42d6a6b0e/documents/IUC5-2a6355db-6371-457e-bca7-a7f5784e1b71_2c93b7c9-0be7-40ee-bd05-beacfe72d62e.html,,,,,, "resorcinol; 1,3-benzenediol",108-46-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8cb3935-4691-4d93-a91f-ade42d6a6b0e/documents/IUC5-2a6355db-6371-457e-bca7-a7f5784e1b71_2c93b7c9-0be7-40ee-bd05-beacfe72d62e.html,,oral,LD50,510 mg/kg bw,, "resorcinol; 1,3-benzenediol",108-46-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8cb3935-4691-4d93-a91f-ade42d6a6b0e/documents/IUC5-2a6355db-6371-457e-bca7-a7f5784e1b71_2c93b7c9-0be7-40ee-bd05-beacfe72d62e.html,,dermal,LD50,"2,830 mg/kg bw",, "resorcinol; 1,3-benzenediol",108-46-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8cb3935-4691-4d93-a91f-ade42d6a6b0e/documents/IUC5-2a6355db-6371-457e-bca7-a7f5784e1b71_2c93b7c9-0be7-40ee-bd05-beacfe72d62e.html,,inhalation,LC50,"2,800 mg/m3",, "5-[(E)-2-(4-hydroxyphenyl)ethenyl]benzene-1,3-diol",501-36-0,No acute toxicity was observed after oral application up to limit concentrations in rats and mice. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60600e0d-38b6-4664-900b-297e039b5b86/documents/9aff4deb-d3db-493a-b5e4-4b599b79301c_e88ba74e-fed0-43dc-9496-6213872b9d60.html,,,,,, "5-[(E)-2-(4-hydroxyphenyl)ethenyl]benzene-1,3-diol",501-36-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60600e0d-38b6-4664-900b-297e039b5b86/documents/9aff4deb-d3db-493a-b5e4-4b599b79301c_e88ba74e-fed0-43dc-9496-6213872b9d60.html,,oral,LD50,"> 10,000 mg/kg bw",no adverse effect observed, Retinol,68-26-8,"Acute oral toxicity rat, similar to OECD guideline 401: LD50 > 2000 mg/kg (95% retinyl propionate)Acute oral toxicity rat, similar to OECD guideline 401: LD50 = 9560 mg/kg (50% retinyl acetate solution) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3087b17c-dc0a-4e6b-a512-ada3ff3a689b/documents/IUC5-a242f660-4897-4400-83bb-3fdee0118a68_b4be9b80-85a7-46ac-83dd-7301448ec8bf.html,,,,,, Retinyl acetate,127-47-9,"A repeated dose (feed) study in rats was available on retinyl acetate that was performed similar to OECD guideline 408:The NOAEL was 1.43 -3.07 mg/kg bw/d (28 ppm) based on slight effects on a few clinical chemical parameters (increased plasma triglyceride levels, slightly increased activity of glutamate pyruvate transaminase and glutamate oxalacetate transaminase) and effects in the liver (increased absolute and relative liver weights, brightened livers, lipid accumulation of the Kupffer cells and decrease of the intrahepatocellular lipid droplets in the peripheral areas of the liver lobules). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4a9b9d6-65d0-4831-8b70-c6ca9c8f35a0/documents/IUC5-3bbbfc22-350f-4978-b959-61ce043b882f_2e2ef407-7b05-4e22-96c4-df290f7ff132.html,,,,,, Retinyl acetate,127-47-9,"Acute oral toxicity rat, similar to OECD guideline 401: LD50 = 9560 mg/kg (50% retinyl acetate solution) Acute oral toxicity rat, similar to OECD guideline 401: LD50 > 2000 mg/kg (60% retinyl acetate solution) Acute oral toxicity rat, similar to OECD guideline 401: LD50 > 2000 mg/kg (95% retinyl propionate) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4a9b9d6-65d0-4831-8b70-c6ca9c8f35a0/documents/IUC5-8df05731-1e8c-4aa6-a214-6d943b31ec12_2e2ef407-7b05-4e22-96c4-df290f7ff132.html,,,,,, Retinyl palmitate,79-81-2,"A repeated dose (feed) study in rats was available on structural analogue retinyl acetate that was performed similar to OECD guideline 408:The NOAEL was 1.43 -3.07 mg/kg bw/d (28 ppm) based on slight effects on a few clinical chemical parameters (increased plasma triglyceride levels, slightly increased activity of glutamate pyruvate transaminase and glutamate oxalacetate transaminase) and effects in the liver (increased absolute and relative liver weights, brightened livers, lipid accumulation of the Kupffer cells and decrease of the intrahepatocellular lipid droplets in the peripheral areas of the liver lobules). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6df4cb9-681f-441b-999d-ffeeef69dd26/documents/IUC5-b438f7ab-ad47-4be0-8344-d759675e5db1_1ac14b7b-0eed-4dae-89c0-5c012d89d655.html,,,,,, Retinyl palmitate,79-81-2,"The key study was the limit oral acute study (OECD guideline 401) in rats with structural analogue retinyl propionate, resulting in an LD 50> 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6df4cb9-681f-441b-999d-ffeeef69dd26/documents/IUC5-6f4737d1-6422-4fe8-9a9d-fbf4913186c9_1ac14b7b-0eed-4dae-89c0-5c012d89d655.html,,,,,, Retinyl propionate,7069-42-3,"The key study was the limit oral acute study (similar to OECD guideline 401) in rats with retinyl proprionate, resulting in an LD50 > 2000 mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e627375a-5618-4e0a-bf15-ebbeebef5732/documents/IUC5-472f9f97-3bff-490c-899b-2e42e24c7f28_03b20146-8444-4806-9e01-320ed7bd3409.html,,,,,, 6-deoxy-L-mannose,3615-41-6," 13-Week feeding study; rat; NOAEL > 1% (highest dose tested; equivalent to 516 and 665 mg/kg in males and females, respectively); Reliability = 2 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cb888e1-df1c-4fa6-9f7e-98c2d5954a76/documents/b4379689-47a1-4538-9dbb-1dee26c6d869_20068f97-bdd8-4784-8021-5b31056cf5c9.html,,,,,, 6-deoxy-L-mannose,3615-41-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cb888e1-df1c-4fa6-9f7e-98c2d5954a76/documents/b4379689-47a1-4538-9dbb-1dee26c6d869_20068f97-bdd8-4784-8021-5b31056cf5c9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,665 mg/kg bw/day,,rat 6-deoxy-L-mannose,3615-41-6, Oral: OECD 425; rat LC50 >5000 mg/kg. Reliability = 1 Inhalation: No study available Dermal: OECD 402; rat LD50 >5000 mg/kg. Reliability = 1 ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cb888e1-df1c-4fa6-9f7e-98c2d5954a76/documents/eebc02ad-ce06-4469-82bc-76172392ebc5_20068f97-bdd8-4784-8021-5b31056cf5c9.html,,,,,, 6-deoxy-L-mannose,3615-41-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cb888e1-df1c-4fa6-9f7e-98c2d5954a76/documents/eebc02ad-ce06-4469-82bc-76172392ebc5_20068f97-bdd8-4784-8021-5b31056cf5c9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 6-deoxy-L-mannose,3615-41-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cb888e1-df1c-4fa6-9f7e-98c2d5954a76/documents/eebc02ad-ce06-4469-82bc-76172392ebc5_20068f97-bdd8-4784-8021-5b31056cf5c9.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Manganese carbonate,598-62-9," Repeated Dose Oral Toxicity: Read-Across From NTP (1993) Under the conditions of the study the NOAEL was 1 700 mg/kg bw for males and 2 000 mg/kg bw for females.   Repeated Dose Inhalation Toxicity: READ-Across From Camner (1985) Under the conditions of the study the LOAEC was 3.9 mg/m3 based on an increase in the size of alveolar macrophages in the high-dose group.   Repeated Dose Dermal Toxicity In accordance with Column 1 of REACH Annexes VIII, IX and X, repeated dose toxicity testing on the most appropriate route of administration shall be conducted having regard to the likely route of human exposure. For the registered substance, inhalation is deemed to be the most likely route of human exposure and therefore repeated dose toxicity testing via the dermal route is not considered scientifically necessary. The physiochemical properties of MnCO3 suggest it is unlikely to be absorbed through the skin. It has a poor water solubility and inorganic ions do not pass easily through the dermal barrier. In addition, MnCO3 is not acutely toxic by the oral route and therefore it is highly unlikely that it would be toxic via the dermal route which in general absorbs chemicals to a much lesser degree than the gastrointestinal tract. Moreover, airborne exposure is the most likely the work place. Furthermore, on animal welfare grounds, adaptation is appropriate in consideration of the extensive use of experimental animals that would be required. Testing is therefore considered unlikely to provide any additional or useful information. A more detailed justification is provided in the report “Justification for adaptation of sub-chronic toxicity studies with MnCO3"" which is attached to Section 13 of this dossier. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6561f05-5f8b-45a3-bd1c-2a4a2c5b94df/documents/IUC5-7cb22c38-10fa-4e0d-a18d-bcbedbdfeb8b_d19d96da-2ed3-4d91-adff-baa02b8d9af4.html,,,,,, Manganese carbonate,598-62-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6561f05-5f8b-45a3-bd1c-2a4a2c5b94df/documents/IUC5-7cb22c38-10fa-4e0d-a18d-bcbedbdfeb8b_d19d96da-2ed3-4d91-adff-baa02b8d9af4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,700 mg/kg bw/day",,rat Manganese carbonate,598-62-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6561f05-5f8b-45a3-bd1c-2a4a2c5b94df/documents/IUC5-7cb22c38-10fa-4e0d-a18d-bcbedbdfeb8b_d19d96da-2ed3-4d91-adff-baa02b8d9af4.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,3.9 mg/m3,,rabbit Manganese carbonate,598-62-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6561f05-5f8b-45a3-bd1c-2a4a2c5b94df/documents/IUC5-7cb22c38-10fa-4e0d-a18d-bcbedbdfeb8b_d19d96da-2ed3-4d91-adff-baa02b8d9af4.html,Repeated dose toxicity – local effects,inhalation,LOAEC,3.9 mg/m3,adverse effect observed,rabbit Manganese carbonate,598-62-9,"ORALLD50 > 2000 mg/kg, OECD 420, EU Method B.1 bis, Pooles (2009) MnCO3INHALATIONLC50 > 5.34 mg/L, OECD 403, EU Method B.2, Griffiths (2010) MnODERMALNo study conducted - testing by the dermal route is not considered to be appropriate for this substance ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6561f05-5f8b-45a3-bd1c-2a4a2c5b94df/documents/IUC5-21018122-59a8-4593-ae64-637bb9b515dc_d19d96da-2ed3-4d91-adff-baa02b8d9af4.html,,,,,, Manganese carbonate,598-62-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6561f05-5f8b-45a3-bd1c-2a4a2c5b94df/documents/IUC5-21018122-59a8-4593-ae64-637bb9b515dc_d19d96da-2ed3-4d91-adff-baa02b8d9af4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Manganese carbonate,598-62-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6561f05-5f8b-45a3-bd1c-2a4a2c5b94df/documents/IUC5-21018122-59a8-4593-ae64-637bb9b515dc_d19d96da-2ed3-4d91-adff-baa02b8d9af4.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Rose, Rosa damascena, ext.",90106-38-0," Acute toxicity, oral in rats: LD50 > 5000 mg/kg bw (equivalent or similar to OECD 401, non-GLP, K, Rel. 2) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6094692-2eba-4cc1-b979-f6df9c26c7a1/documents/da530229-f428-4817-aca4-cba406c1d24a_84898ca4-6588-4218-a147-4938f82fc466.html,,,,,, "Rose, Rosa damascena, ext.",90106-38-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6094692-2eba-4cc1-b979-f6df9c26c7a1/documents/da530229-f428-4817-aca4-cba406c1d24a_84898ca4-6588-4218-a147-4938f82fc466.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Rosemary, ext.",84604-14-8, Repeated dose toxicity using read-across from Eucalyptus oil (OECD TG 422): NOAEL = 300 mg/kg bw ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7cccda87-ce47-4ebc-b920-dd72a7c8eb4e/documents/3d10af4a-03a8-45c4-9dc0-e5e6f8ec19d9_e6be3c61-dd6c-4d9f-b808-98b55f85003e.html,,,,,, "Rosemary, ext.",84604-14-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7cccda87-ce47-4ebc-b920-dd72a7c8eb4e/documents/3d10af4a-03a8-45c4-9dc0-e5e6f8ec19d9_e6be3c61-dd6c-4d9f-b808-98b55f85003e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Rosemary, ext.",84604-14-8, Acute oral toxicity (tested in a study similar to OECD TG 401): LD50 = 5000 mg/kg bw Acute dermal toxicity (tested in a study similar to OECD TG 402): LD50 = 8000 mg/kg bw Acute inhalation toxicity using route to route extrapolation from the oral route ca. 13000 mg/m3. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cccda87-ce47-4ebc-b920-dd72a7c8eb4e/documents/c604d119-21eb-4369-97e9-4d5329ae750e_e6be3c61-dd6c-4d9f-b808-98b55f85003e.html,,,,,, "Rosemary, ext.",84604-14-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cccda87-ce47-4ebc-b920-dd72a7c8eb4e/documents/c604d119-21eb-4369-97e9-4d5329ae750e_e6be3c61-dd6c-4d9f-b808-98b55f85003e.html,,oral,LD50,"5,000 mg/kg bw",adverse effect observed, "Rosemary, ext.",84604-14-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cccda87-ce47-4ebc-b920-dd72a7c8eb4e/documents/c604d119-21eb-4369-97e9-4d5329ae750e_e6be3c61-dd6c-4d9f-b808-98b55f85003e.html,,dermal,LD50,"8,000 mg/kg bw",adverse effect observed, "1,2-benzisothiazol-3(2H)-one 1,1-dioxide",81-07-2,"The substance 1,2-benzisothiazol-3(2H)-one 1,1-dioxide does not exhibit repeated dose toxicity by the oral ,inhalation and dermal route. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7687fb27-da97-4fff-9886-3ac05497a647/documents/IUC5-d975921e-8bc4-4ecc-84f2-45e9643c8cf0_0cef3c50-187a-4b83-8158-2e1cefcb8bcd.html,,,,,, "1,2-benzisothiazol-3(2H)-one 1,1-dioxide",81-07-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7687fb27-da97-4fff-9886-3ac05497a647/documents/IUC5-d975921e-8bc4-4ecc-84f2-45e9643c8cf0_0cef3c50-187a-4b83-8158-2e1cefcb8bcd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"7,500 mg/kg bw/day",,rat "1,2-benzisothiazol-3(2H)-one 1,1-dioxide",81-07-2,"The substance 1,2-benzisothiazol-3(2H)-one 1,1-dioxide is not expected to show acute toxicity effect by the oral, inhalation and dermal route. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7687fb27-da97-4fff-9886-3ac05497a647/documents/IUC5-3a691d7b-b0e0-426f-9d90-e1b8f388311a_0cef3c50-187a-4b83-8158-2e1cefcb8bcd.html,,,,,, "1,2-benzisothiazol-3(2H)-one 1,1-dioxide",81-07-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7687fb27-da97-4fff-9886-3ac05497a647/documents/IUC5-3a691d7b-b0e0-426f-9d90-e1b8f388311a_0cef3c50-187a-4b83-8158-2e1cefcb8bcd.html,,oral,LD50,"17,000 mg/kg bw",no adverse effect observed, "1,2-benzisothiazol-3(2H)-one 1,1-dioxide",81-07-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7687fb27-da97-4fff-9886-3ac05497a647/documents/IUC5-3a691d7b-b0e0-426f-9d90-e1b8f388311a_0cef3c50-187a-4b83-8158-2e1cefcb8bcd.html,,dermal,LD50,"4,694 mg/kg bw",no adverse effect observed, "Saccharomyces cerevisiae, ext.",84604-16-0,There were two subchronic oral toxicity studies on surrogates available which were conducted according to current guidelines and in compliance with GLP. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c2685a2-4ad6-45fc-b7a3-2a5393e85636/documents/IUC5-a5e0ed9a-897f-42d3-b604-47e7c1b094d6_453c7339-c031-42a3-aa28-bfe55e908d2f.html,,,,,, "Saccharomyces cerevisiae, ext.",84604-16-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c2685a2-4ad6-45fc-b7a3-2a5393e85636/documents/IUC5-a5e0ed9a-897f-42d3-b604-47e7c1b094d6_453c7339-c031-42a3-aa28-bfe55e908d2f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Saccharomyces cerevisiae, ext.",84604-16-0,Three acute oral toxicity studies are available (two with mice and one with rat) of which two were performed according to OECD guidelines and in compliance with GLP. An acute dermal toxicity study was available performed according to OECD guidelines and in compliance with GLP. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c2685a2-4ad6-45fc-b7a3-2a5393e85636/documents/IUC5-88cb7496-43bb-4ad4-a4fc-9b0b4c47f1c6_453c7339-c031-42a3-aa28-bfe55e908d2f.html,,,,,, "Saccharomyces cerevisiae, ext.",84604-16-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c2685a2-4ad6-45fc-b7a3-2a5393e85636/documents/IUC5-88cb7496-43bb-4ad4-a4fc-9b0b4c47f1c6_453c7339-c031-42a3-aa28-bfe55e908d2f.html,,oral,LD50,"2,000 mg/kg bw",, "Saccharomyces cerevisiae, ext.",84604-16-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c2685a2-4ad6-45fc-b7a3-2a5393e85636/documents/IUC5-88cb7496-43bb-4ad4-a4fc-9b0b4c47f1c6_453c7339-c031-42a3-aa28-bfe55e908d2f.html,,dermal,LD50,"2,000 mg/kg bw",, Salicylamide,65-45-2,"13-week oral-gavage study, rat, highest dose 200 mg/kg bw, no guideline, Ichniowski 1946. No signs of toxicity or histopathological changes. Leucopenia suspected, but not reproducible in second, specific hematology study.67-day drinking water study, mouse, 250mg/kg, no guideline, Drebinger 1952. No signs of toxicityCombined 3-generation study, mouse, no guideline, non-standard method, Wright 1967. Depression of physical condition, shortening of survival time, no increase in mammary carcinoma. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdf10cf5-1a92-40f6-bbca-5d0ff56ae59b/documents/IUC5-06926879-579d-4b3d-b3f3-7e084a8db82e_0b5333f6-7a64-4b9a-a35b-93c843de4aba.html,,,,,, Salicylamide,65-45-2,"Oral: LD50= 980 mg/kg bw (C.I. 817-1176 mg/kg bw), male, rat, OECD 401, Boxill 1958Oral: LD50 >1600 <2000 mg/kg bw, rat, OECD 401, Ichniowski 1946Oral: LD50=1400 mg/kg bw, rat, no guideline, Hart 1947Oral: LD50=1200 (960-1500) mg/kg bw, male/female, rat, no guideline, Way 1953Oral: LD50=1600 mg/kg bw, rat, no guideline, Bekemeier 1955Oral: LD50=1490 mg/kg bw, rat, no guideline, Drebinger 1952 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdf10cf5-1a92-40f6-bbca-5d0ff56ae59b/documents/IUC5-d17b9f83-bb13-4968-b0f5-23b28da04f18_0b5333f6-7a64-4b9a-a35b-93c843de4aba.html,,,,,, Salicylamide,65-45-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdf10cf5-1a92-40f6-bbca-5d0ff56ae59b/documents/IUC5-d17b9f83-bb13-4968-b0f5-23b28da04f18_0b5333f6-7a64-4b9a-a35b-93c843de4aba.html,,oral,LD50,980 mg/kg bw,adverse effect observed, Salicylic acid,69-72-7," No valid repeated dose toxicity studies on salicylic acid are available. A read-across approach is therefore proposed from studies on Methyl salicylate (MeS) which is readily metabolised to salicylic acid (See section.7.1.1). A set of studies was conducted on MeS by Webb & Hansen (1963), consisting of oral feeding studies of duration 17 weeks and 2 years in rats, studies in dogs by capsule administration of duration 59 days and 2 years, and a dermal study in rabbits.  These studies did not examine all the parameters recommended in the current OECD guidelines 409 and 452, however they were conducted according to good scientific principles by US FDA.  The chronic studies in rat and dog are therefore proposed as key studies for this endpoint, with the subchronic studies in rats and dogs as supporting study. A second set of subacute oral studies was conducted on MeS by Abbott & Harrisson (1978) to further investigate the effects on bone in rats and liver in dogs, identified in the studies by Webb & Hansen.  These are considered to be acceptable as supporting studies. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58350bce-5d00-4254-90f2-fc9bbae79437/documents/9c87e6ea-75c3-4a65-905c-760ed931566a_a56b369a-461c-46ec-8a63-f169a8cbd426.html,,,,,, Salicylic acid,69-72-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58350bce-5d00-4254-90f2-fc9bbae79437/documents/9c87e6ea-75c3-4a65-905c-760ed931566a_a56b369a-461c-46ec-8a63-f169a8cbd426.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,635 mg/m3,,rat Salicylic acid,69-72-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58350bce-5d00-4254-90f2-fc9bbae79437/documents/9c87e6ea-75c3-4a65-905c-760ed931566a_a56b369a-461c-46ec-8a63-f169a8cbd426.html,Chronic toxicity – systemic effects,oral,NOAEL,45.4 mg/kg bw/day,,rat Salicylic acid,69-72-7,"For acute oral toxicity, a study report (Bio-Fax, 1971; Rel. 2) has been chosen as key study, reporting oral LD50 891 mg/kg in rats. Publications by Hasegawa et al (1989) and Schlede et al. (1995) on NaS (both Rel. 2) were chosen as supporting studies.For acute dermal toxicity, one Rel. 1 study report (Bomhard, 1989) has been chosen as key study. No mortality and no local changes were noted, with dermal LD50 > 2000 mg/kg.For acute inhalation toxicity, only one Klim. 3 on SA itself is available (BioFax, 1971). Salicylic acid was administered as a dust at 0.9 mg/l, at which concentration no mortality occurred, with signs of slight irritation only in one animal during exposure. Since this study alone is not sufficient to fulfil this endpoint, it is used by weight of evidence with a subacute inhalation toxicity study (Gage, 1970) on methyl salicylate vapour, which supports a conclusion of low potential for systemic toxicity by inhalation. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58350bce-5d00-4254-90f2-fc9bbae79437/documents/c82f4023-e25d-4342-8e17-48862bd24ba1_a56b369a-461c-46ec-8a63-f169a8cbd426.html,,,,,, Salicylic acid,69-72-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58350bce-5d00-4254-90f2-fc9bbae79437/documents/c82f4023-e25d-4342-8e17-48862bd24ba1_a56b369a-461c-46ec-8a63-f169a8cbd426.html,,oral,LD50,891 mg/kg bw,adverse effect observed, Salicylic acid,69-72-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58350bce-5d00-4254-90f2-fc9bbae79437/documents/c82f4023-e25d-4342-8e17-48862bd24ba1_a56b369a-461c-46ec-8a63-f169a8cbd426.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Willow, Salix alba, ext.",84082-82-6, Acute oral toxicity: A limit test with 2000 mg/kg bw was performed. WWBE did not cause mortality or severe toxic effects in any of the animals. The LD50 was determined to be >2000 mg/kg bw. Acute dermal toxicity: Dermal toxicity testing is waved based on the low oral toxicity (no effects at the limit concentration 2000 mg/kg bw) according to provisions in Column 2 of Annex VII of REACH and the OECD Guidance Document No. 237. Acute inhalation toxicity: An acute inhalation toxicity study is currently running and will be included in a dossier update ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4719c574-3486-4832-9e05-5d379034b80e/documents/12bcc64e-f320-45c4-879a-fe0b8f22aea2_1ba6be16-8afe-477c-a349-03b60bcdb8d6.html,,,,,, "Willow, Salix alba, ext.",84082-82-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4719c574-3486-4832-9e05-5d379034b80e/documents/12bcc64e-f320-45c4-879a-fe0b8f22aea2_1ba6be16-8afe-477c-a349-03b60bcdb8d6.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Sage, Salvia lavandulifolia, ext.",90106-49-3," Based on a weight of evidence approach, the acute toxicity oral of this UVCB substance can be estimated using adequate toxicity data of major constituents, greater than 1% in the mixture. 9 constituents were considered, representing 80% of the UVCB. These data are summarized in the table below.   Consistuent % Acute tox oral DL50 oral (mg/kg=ppm) Ci/ETAi Animals Camphor 27,68 1310 0,02112977 mice Cineol 23,77 2480 0,00958468 rats Camphene 7,08 5000 0,001416 rats Alpha pinene 5,56 3700 0,0015027 rats Limonene 4,53 5600 0,00080893 mice Beta pinene 4,41 4700 0,0009383 rats Myrcene  2,77 5000 0,000554 rats Linalyl acetate 2,56 2864 0,00089385 rats Linalol 1,59 2790 0,00056989 rats somme 79,95 somme 0,03739812                                                                                                           The acute toxicity oral was estimated using the following additivity formula, as recommended in the Regulation (EC) No 1272/2008 (CLP) part 3.1.3.6.2.3.: 100-(∑ Ci unkown if > 10 %) / ETA mix = ∑ (Ci / ETAi)Where,Ci = concentration of component i (weight percentage); i  =  the  individual  ingredient  from  1  to n ; n  =  the  number  of  ingredients ; ATE  i   =  Acute  Toxicity  Estimate of  ingredient  i.   ETA mix = 2137.8 mg/kg ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7441239b-975f-4251-b14c-b1dfb7d07bc7/documents/41572df0-3129-4d38-b9ec-06ad98ea523d_967abb8b-06b4-4b00-9638-b8a7a67d7b40.html,,,,,, "Sage, Salvia lavandulifolia, ext.",90106-49-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7441239b-975f-4251-b14c-b1dfb7d07bc7/documents/41572df0-3129-4d38-b9ec-06ad98ea523d_967abb8b-06b4-4b00-9638-b8a7a67d7b40.html,,oral,LD50,"2,138 mg/kg bw",no adverse effect observed, "Sage, Salvia officinalis, ext.",84082-79-1," In an acute oral toxicity study on rats, the Oral LD50 was found to be superior to 2000 mg/kg. (pre- GLP, Rel. K2) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0f757fa-ac82-4ac5-a35d-2d0e5f3fe944/documents/4cdc6602-134e-4f24-a8cc-7ea5c99509e4_103b3fdd-d088-4cd0-a3e8-79317021bb0f.html,,,,,, "Sage, Salvia officinalis, ext.",84082-79-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0f757fa-ac82-4ac5-a35d-2d0e5f3fe944/documents/4cdc6602-134e-4f24-a8cc-7ea5c99509e4_103b3fdd-d088-4cd0-a3e8-79317021bb0f.html,,oral,LD50,"2,600 mg/kg bw",adverse effect observed, "Sage, Salvia sclarea, ext.",84775-83-7," In an acute oral toxicity study, the oral LD50 of test substance was 5600 mg/kg bw with 95 % confidence limits of 5000-6200 mg/kg bw in male rats. (Pre-GLP, Rel. K2) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad93d5b2-786b-4cc2-a937-0139d17aba0b/documents/2a038e84-8390-4721-890d-70057ca02ffd_8d5b0b97-d123-4d79-9054-eec2ee6b7b5f.html,,,,,, "Sage, Salvia sclarea, ext.",84775-83-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad93d5b2-786b-4cc2-a937-0139d17aba0b/documents/2a038e84-8390-4721-890d-70057ca02ffd_8d5b0b97-d123-4d79-9054-eec2ee6b7b5f.html,,oral,LD50,"5,600 mg/kg bw",adverse effect observed, "Sandalwood, ext.",84787-70-2," No mortalities or signs of toxicity have been observed in a limit test with sandalwood, ext. by oral application at a limit concentration of 5000 mg/kg body weight in rats. Studies following dermal or inhalation exposure are not available. However, in a review article, data on acute dermal toxicity were found indicating absence of dermal toxicity (LD50 > 5 g/kg), but the original study is not available for review. Also, a study about acute inhalation toxicity is cited in a review article, but the results were cited as internal comunication, not available for review. Also, exposure concentrations of mice were low (50 - 180 mg/m3), but no mortality was seen and motility effects had been investigated, showing that mice and mice pre-treated with caffeine showed a reduced motility, as expected. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29389a49-4e98-4739-a2aa-2b8e81b69f98/documents/8dfbe909-1b0d-4f2e-b7eb-80c500c08e93_4977d2ae-ac1f-401e-a1a3-1fdb6abc8002.html,,,,,, "Sandalwood, ext.",84787-70-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29389a49-4e98-4739-a2aa-2b8e81b69f98/documents/8dfbe909-1b0d-4f2e-b7eb-80c500c08e93_4977d2ae-ac1f-401e-a1a3-1fdb6abc8002.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Santalum austro-caledonicum, ext.",91845-48-6," Acute oral toxicity study: OECD 423, The DL50 (rats) is higher than 2000 mg/kg (GLP, K1) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b35006c-a778-4b2f-9b30-73705d411098/documents/494aedea-304e-4f62-ab48-625a2f6dbb23_f0bf5968-5ba5-4810-a1b1-afd348015a3e.html,,,,,, "Santalum austro-caledonicum, ext.",91845-48-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b35006c-a778-4b2f-9b30-73705d411098/documents/494aedea-304e-4f62-ab48-625a2f6dbb23_f0bf5968-5ba5-4810-a1b1-afd348015a3e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Saponins,8047-15-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 4 studies with reliability of 2 are available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29f188e2-c87c-48b0-8137-450dfdf3dcc7/documents/IUC5-638b338d-797a-4544-b61c-e7e187a9f3fd_d3d2e717-ae72-4721-a1c8-13074dbce58b.html,,,,,, Saponins,8047-15-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29f188e2-c87c-48b0-8137-450dfdf3dcc7/documents/IUC5-638b338d-797a-4544-b61c-e7e187a9f3fd_d3d2e717-ae72-4721-a1c8-13074dbce58b.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,500 mg/kg bw/day",,rat Saponins,8047-15-2,"Acute oral toxicity: The acute oral toxicity of the liquid QUILLAJA EXTRACT QL AGRI, LOTE: 260208-0700 was investigated according to US EPA Guideline EPA OPPTS 870.1100. A group of 3 female Sprague Dawley rats were administered a liquid extract of Quillaja saponaria at a single dose of 5000 mg/kg bw by gavage.No mortality and no clinical signs of toxicity were obeserved. No abnormalities were recorded durcing necropsies. Therefore the acute oral LD50 value was estimated as > 5000 mg/kg bw.Acute toxicity by the inhalation route: The acute toxicity by the the inhalation route of Quillaja saponaria powder was examined according to OECD Guideline 403. A limit test with an exposition of 0.45 mg/L as a nominal concentration was performed due to the physical-chemical properties of the test substance. This was the highest technical achievable concentration. A group of 5 males and 5 females received nasal only exposure to aerosol concentrations of the test substance during 4 hours. No mortality and clinical sign of toxicity were observed. No abnormalities were recorded during necropsy. Therefore the acute LC50 value of Quillaja saponaria powder can be stated as > 0.45 mg/l.Acute dermal toxicity: The acute dermal toxicity of a liquid Quillaja saponaria extract was investigated according to US EPA Guideline EPA OPPTS 870.1200 (Acute Dermal Toxicity).The test item was applied as a single dose of 2000 mg/kg bw to the shaved dorsal area of the trunk of 5 male and 5 female Sprague Dawley rats. The coverage of the exposed area was removed after 24 hours. No mortolatity or clinical signs of toxicity was observed. No abnormalites were recorded durcing necropsy. Therefore the acute dermal LD50 was estimated as > 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29f188e2-c87c-48b0-8137-450dfdf3dcc7/documents/IUC5-b792c918-ea76-44af-afab-a7d992e1b4a5_d3d2e717-ae72-4721-a1c8-13074dbce58b.html,,,,,, Saponins,8047-15-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29f188e2-c87c-48b0-8137-450dfdf3dcc7/documents/IUC5-b792c918-ea76-44af-afab-a7d992e1b4a5_d3d2e717-ae72-4721-a1c8-13074dbce58b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Saponins,8047-15-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29f188e2-c87c-48b0-8137-450dfdf3dcc7/documents/IUC5-b792c918-ea76-44af-afab-a7d992e1b4a5_d3d2e717-ae72-4721-a1c8-13074dbce58b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Saponins,8047-15-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29f188e2-c87c-48b0-8137-450dfdf3dcc7/documents/IUC5-b792c918-ea76-44af-afab-a7d992e1b4a5_d3d2e717-ae72-4721-a1c8-13074dbce58b.html,,inhalation,LC50,450 mg/m3,no adverse effect observed, "4,4'-methylenedicyclohexyl diisocyanate",5124-30-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13e9a8d8-eafd-4e80-8e77-448ede1fe41c/documents/1119bd64-6220-4f4f-bed8-c7b8b2dc174c_4671f1f4-7a4d-428e-9024-97f3263f0dac.html,Repeated dose toxicity – local effects,inhalation,NOAEC,3 mg/m3,adverse effect observed,rat "4,4'-methylenedicyclohexyl diisocyanate",5124-30-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13e9a8d8-eafd-4e80-8e77-448ede1fe41c/documents/b8150a70-0a56-43e9-82e9-1bbec0e0e06a_4671f1f4-7a4d-428e-9024-97f3263f0dac.html,,oral,LD50,"18,200 mg/kg bw",adverse effect observed, "4,4'-methylenedicyclohexyl diisocyanate",5124-30-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13e9a8d8-eafd-4e80-8e77-448ede1fe41c/documents/b8150a70-0a56-43e9-82e9-1bbec0e0e06a_4671f1f4-7a4d-428e-9024-97f3263f0dac.html,,dermal,discriminating dose,"7,000 mg/kg bw",no adverse effect observed, "4,4'-methylenedicyclohexyl diisocyanate",5124-30-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13e9a8d8-eafd-4e80-8e77-448ede1fe41c/documents/b8150a70-0a56-43e9-82e9-1bbec0e0e06a_4671f1f4-7a4d-428e-9024-97f3263f0dac.html,,inhalation,LC50,434 mg/m3,adverse effect observed, "Savory, Satureja hortensis, ext.",84775-98-4," The study does not need to be conducted because the substance is classified as skin corrosion (Category 1B/1C). The classification of the substance is based on the available data for LD50 or classification of the constituents of the UVCB substance according to Guidance on the Application of CLP Criteria – Guidance to regulation (EC) No 1272/2008 ECHA. The calculated value of ATEmix according to the formula in Section 3.1.3.6.1 of Annex I to Regulation (EC) No 1272/2008 is 680,272. The Summer savory oil has 11 known constituents. The Acute oral toxicity of the oil is calculated on the basis of the available data about LD50 of 2 constituents (Carvacrol, alpha-Terpinene) and the self-classification of 2 other constituents (alpha-Pinene, alpha-Thujene). One constituent (Dipentene/ Limonene) has harmonized classification and it is not classified as acute oral toxicity. Other 6 constituents are with high LD50 values (above 2000 mg/kg bw), they are not classified as acutely toxic via oral route and therefore their LD50 are not taken into account in the calculation. On the basis of the available data on constituents and the criteria for classifying mixtures according to the Regulation (EC) No 1272/2008, the Summer Savory oil is classified as Acute Toxicity (oral) category 4, H302 Harmful if swallowed.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e15efc31-a00e-47f6-b7c2-d7207c8c7abb/documents/865c30eb-8015-4d48-b235-097e3007babd_f88b2fd1-fa29-4357-b4d2-86bcb8e4007f.html,,,,,, "Savory, Satureja hortensis, ext.",84775-98-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e15efc31-a00e-47f6-b7c2-d7207c8c7abb/documents/865c30eb-8015-4d48-b235-097e3007babd_f88b2fd1-fa29-4357-b4d2-86bcb8e4007f.html,,oral,LD50,"5,000 mg/kg bw",, "Schinus molle, ext.",94334-31-3, Acute oral toxicity (tested in a study similar to OECD TG 401): LD50 > 5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a72b394-fd16-493a-898d-40b9bfa6679b/documents/9af3037d-abb5-407d-852f-72b440560d06_99af9e93-4295-4176-acf2-5f5128935267.html,,,,,, "[3aR-(3aα,5aβ,9aα,9bβ)]decahydro-3a,6,6,9a-tetramethylnaphth[2,1-b]furan-2(1H)-one",564-20-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80699955-d617-4dbb-ad81-96b61d2b2dc3/documents/6363496c-4097-4508-aa76-5b6b9335dcaa_ba57cc95-1c7a-4c23-b5c3-0136bfc6e4f6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium chloride,7647-14-5,Chronic administration at doses of 4% sodium chloride in the diet over a period of 2 years induced elevated blood pressure in the rats. This dose can be considered as an excessive exposure. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c5936077-0934-4ff3-882e-95b7f9394599/documents/IUC5-17b0bde3-16b4-4514-8ca0-adc5dd190812_1ef84562-4fb1-423f-8c75-b87b09c39162.html,,,,,, Sodium chloride,7647-14-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c5936077-0934-4ff3-882e-95b7f9394599/documents/IUC5-17b0bde3-16b4-4514-8ca0-adc5dd190812_1ef84562-4fb1-423f-8c75-b87b09c39162.html,Chronic toxicity – systemic effects,oral,LOAEL,"2,533 mg/kg bw/day",,rat Sodium chloride,7647-14-5,"The acute oral LD50 to rats is greater than 3550 mg/kg (95% fiducial limits 3040 - 4140), the acute dermal LD50 to rabbits is 10000 mg/kg and the acute inhalation LC50 to rats is greater than 42 mg/l (42000 mg/m3) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5936077-0934-4ff3-882e-95b7f9394599/documents/IUC5-4d66cec2-ae6e-4b05-8e50-1e6f2e200927_1ef84562-4fb1-423f-8c75-b87b09c39162.html,,,,,, Sodium chloride,7647-14-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5936077-0934-4ff3-882e-95b7f9394599/documents/IUC5-4d66cec2-ae6e-4b05-8e50-1e6f2e200927_1ef84562-4fb1-423f-8c75-b87b09c39162.html,,oral,LD50,"3,550 mg/kg bw",, Sodium chloride,7647-14-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5936077-0934-4ff3-882e-95b7f9394599/documents/IUC5-4d66cec2-ae6e-4b05-8e50-1e6f2e200927_1ef84562-4fb1-423f-8c75-b87b09c39162.html,,dermal,LD50,"10,000 mg/kg bw",, Sodium chloride,7647-14-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5936077-0934-4ff3-882e-95b7f9394599/documents/IUC5-4d66cec2-ae6e-4b05-8e50-1e6f2e200927_1ef84562-4fb1-423f-8c75-b87b09c39162.html,,inhalation,LC50,"42,000 mg/m3",, Sebacic acid,111-20-6,Oral: NOAEL ≥ 1000 mg/kg bw; rat; according to OECD TG 408; GLP; K1Inhalation: no data availableDermal: no data available ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7cead72-a800-46b4-a672-b979f0aa1919/documents/IUC5-f937cf99-bab9-4787-a63d-7e41ff54376b_fabfb972-521e-4dd8-b0b7-9dd35ddb2d37.html,,,,,, Sebacic acid,111-20-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7cead72-a800-46b4-a672-b979f0aa1919/documents/IUC5-f937cf99-bab9-4787-a63d-7e41ff54376b_fabfb972-521e-4dd8-b0b7-9dd35ddb2d37.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"> 1,000 mg/kg bw/day",,rat Sebacic acid,111-20-6,"Oral: Read-Across; LD50 > 5000 mg/kg bw; rat; similar to OECD TG 401; non-GLP; K2Inhalation: no data availableDermal: LD50 > 2000 mg/kg bw; rat; 24 h, according to OECD TG 402; GLP; K1 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7cead72-a800-46b4-a672-b979f0aa1919/documents/IUC5-9ad75eff-9079-4a3b-81df-dc2020cda0a5_fabfb972-521e-4dd8-b0b7-9dd35ddb2d37.html,,,,,, Sebacic acid,111-20-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7cead72-a800-46b4-a672-b979f0aa1919/documents/IUC5-9ad75eff-9079-4a3b-81df-dc2020cda0a5_fabfb972-521e-4dd8-b0b7-9dd35ddb2d37.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Sebacic acid,111-20-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7cead72-a800-46b4-a672-b979f0aa1919/documents/IUC5-9ad75eff-9079-4a3b-81df-dc2020cda0a5_fabfb972-521e-4dd8-b0b7-9dd35ddb2d37.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Butan-2-ol,78-92-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9a57719-9a23-4523-8c5f-16ec0708a742/documents/aee3ec7c-05f6-4e66-9f2b-bbf8c7a65c47_622c38f5-1794-4c96-8633-9a1a84895715.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"12,290 mg/m3",,rat Butan-2-ol,78-92-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9a57719-9a23-4523-8c5f-16ec0708a742/documents/4ed6d7f0-b72c-4daf-b7aa-c3120edf1bb6_622c38f5-1794-4c96-8633-9a1a84895715.html,,oral,LD50,"2,193 mg/kg bw",no adverse effect observed, Butan-2-ol,78-92-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9a57719-9a23-4523-8c5f-16ec0708a742/documents/4ed6d7f0-b72c-4daf-b7aa-c3120edf1bb6_622c38f5-1794-4c96-8633-9a1a84895715.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Selenium disulphide,7488-56-4," Acute Toxicity via Oral Route Key value determined in a GLP accredited laboratory study using the acute toxicity class method, in accordance with OECD Guideline 423, and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.tris. The oral LD50 value of selenium disulphide in Wistar female rats was established to be between 300 - 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8063ef2-2f42-4944-a115-54e6d0c62ffc/documents/5b21d075-48b1-4458-885c-beca5f408bd7_2e93969d-765a-40e9-8593-fa3ef77262f5.html,,,,,, Selenium disulphide,7488-56-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8063ef2-2f42-4944-a115-54e6d0c62ffc/documents/5b21d075-48b1-4458-885c-beca5f408bd7_2e93969d-765a-40e9-8593-fa3ef77262f5.html,,oral,LD50,300 mg/kg bw,adverse effect observed, L-serine,56-45-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12f16f05-e7c9-4284-84de-5246275e6508/documents/IUC5-ba00fc17-cfe8-42b5-99dc-6c743bdb3249_96b621ff-e786-4f86-a688-52e129299a7d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,000 mg/kg bw/day",,rat Silicon,7440-21-3,"The effects of repeated exposure to silicon particles were recently investigated in a subchronic inhalation study. The results showed no signs of systemic toxicity. The main findings were very mild, local inflammatory effects observed in the lungs and lung-associated lymph nodes. No severe exposure-related effects were observed. No other studies on repeated dose toxicity of silicon were available. Repeated dose toxicity data on synthetic amorphous silicon dioxide and calcium silicate show that the silicon ion does not cause systemic target organ toxicity after oral exposure. The comparative in vitro data on the dissolution kinetics of silicon and synthetic amorphous silica in different artificial biological fluids show that the dissolution of silicon from silicon particles in vitro is similar or lower than that of synthetic amorphous silica. Therefore, the bioavailabity of silicon from silicon particles is likely to be similar or lower than that of synthetic amorphous silica. Based on read-across, no systemic toxicity is expected from oral exposure to silicon. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/697d4d1a-913b-4509-b3c1-03de5452ca37/documents/IUC5-a75fe423-9ec4-4c90-887a-165be4e06b00_55d79213-a7e0-4a3b-a089-672bdac127b8.html,,,,,, Silicon,7440-21-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/697d4d1a-913b-4509-b3c1-03de5452ca37/documents/IUC5-a75fe423-9ec4-4c90-887a-165be4e06b00_55d79213-a7e0-4a3b-a089-672bdac127b8.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,16 mg/m3,,rat Silicon,7440-21-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/697d4d1a-913b-4509-b3c1-03de5452ca37/documents/IUC5-a75fe423-9ec4-4c90-887a-165be4e06b00_55d79213-a7e0-4a3b-a089-672bdac127b8.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4 mg/m3,adverse effect observed,rat Silicon,7440-21-3,"Animal data on acute toxicity of synthetic amorphous silica which can be used for read-across do not show acute oral, inhalation or dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/697d4d1a-913b-4509-b3c1-03de5452ca37/documents/IUC5-15cd0caf-86ed-42d4-942a-ae327a899570_55d79213-a7e0-4a3b-a089-672bdac127b8.html,,,,,, Silicon,7440-21-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/697d4d1a-913b-4509-b3c1-03de5452ca37/documents/IUC5-15cd0caf-86ed-42d4-942a-ae327a899570_55d79213-a7e0-4a3b-a089-672bdac127b8.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Silicon carbide,409-21-2,"Silicon carbide is a chemically inert mineral substance. The determination of water solubility showed that silicon carbide “can be considered as practically insoluble in water” (see chapter 4.8), which is an indicator of a low bioavailability. The low bioavailability of silicon carbide was confirmed by a 10 days repeated dose inhalation toxicity test with silicon carbide (J Bruch et al. 1993; see chapter 7.5.3), in which this substance showed practically no lymphatic penetration. In addition, single dose toxicity studies by intratracheal instillations on silicon carbide with 3 to 12 months period observations (Bruch and Rehn, 1996; Bégin et al. 1989; Bruch et al. 1993; see chapters 7.2.2) also are suggestive of a the lack of adverse effects of silicon carbide in repeated dose toxicity test. This type of study (single dose administration) is used for drug regulatory purposes to observe the long-term effects of a substance.In a cohort study (Edling, 1987; see chapter 7.10.2) more than 500 individuals exposed to silicon carbide working in the manufacture of abrasives were followed up from 1958 until 1983. The study revealed no significant increase in total mortality, cancer mortality, or incidence of non-malignant respiratory diseases ascribable to silicon carbide.Against this background, based on the low bioavailability of silicon carbide and the lack of toxicological activity observed, we conclude that the substance has no adverse effects occurring as a result of repeated daily exposure during a prolonged period of time. A short-term repeated dose study confirmed this previous statement. Consequently tests on sub-chronic repeated dose toxicity of silicon carbide appear to be dispensable. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c21ff6f6-8113-4ab8-bdec-a964417996ef/documents/d345c88f-b682-4657-8a8f-b5b5c7afbb9f_a9dec1c4-cbd7-43fe-8976-35290a3e2488.html,,,,,, Silicon carbide,409-21-2,"In conclusion, the present investigation confirmed that SiC itself, along with SiC commercial products, has none or only a limited toxicological potential on the cellular level. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c21ff6f6-8113-4ab8-bdec-a964417996ef/documents/774b75a6-c652-4053-9eb9-68b11b299538_a9dec1c4-cbd7-43fe-8976-35290a3e2488.html,,,,,, Silver carbonate,534-16-7,"A reliable study available for acute oral toxicity of silver(I)carbonate is available (rat, LD50 > 2000 mg/kg bw). Similar acute oral toxicity studies with other silver substances, which all indicate low acute oral toxicity, are included in this dossier for comparative reasons. Silver carbonate is not classified as acutely toxic, according to Regulation (EC) 1272/2008. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/decad58b-ab9b-44c4-a2d8-e6f8d9429483/documents/IUC5-5ea4c3f6-9437-48fb-b4ea-8358a7cc1fc7_00e4cb53-70f2-4f62-8b9e-9b1c80119643.html,,,,,, Silver carbonate,534-16-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/decad58b-ab9b-44c4-a2d8-e6f8d9429483/documents/IUC5-5ea4c3f6-9437-48fb-b4ea-8358a7cc1fc7_00e4cb53-70f2-4f62-8b9e-9b1c80119643.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Silver chloride,7783-90-6,"  A read-across approach from silver acetate (as source substance) is used for other silver compounds. The Toxicokinetic study confirmed the read-across between silver acetate and other silver compounds. For further details please refer to separate report ""CSR Annex 7 Read Across Justification Human Health_Nov 2022"" which is attached to the CSR in section 13. Key information considered: Lourens et al. 2022 performed a repeated dose toxicity (90-days) study according to OECD 408 and following GLP principles, with silver acetate administered via the diet to Wistar Han rats at 40, 120 and 320 mg/kg bw/day. Based on the results, the NOAEL was a target dose level of 120 mg/kg bw/day for males and a target dose of at least 320 mg/kg bw/day for female. Hadrup et al. 2012 conducted a subacute (28-day) oral toxicity study comparing the effects of silver acetate to those of nanoscale silver (see also below). Silver acetate was tested at only one dose (14 mg/kg bw/d, corresponding to 9 mg silver/kg bw/d) and in female rats only (for data on silver nanomaterials, see below). Oral exposure to silver in ionic form (as acetate) was reported by the authors to be associated with lower body weight gain, an increase in ALP and a decrease in urea concentrations in plasma and lower absolute and relative thymus weights. In lack of other more conclusive data, this study despite its limitations indicates a tentative LOEL for ionic silver of 9 mg/kg bw/d. Boudreau et al. 2016 conducted a 90-day (OECD 408) oral toxicity study.  Sprague Dawley rats of seven-week-old rats (10 rats per sex per group) were dosed with silver acetate (AgAc) at 100, 200, and 400 mg/kg bw; and controls (water). Rats exposed to AgAc at high dose (400 mg/kg bw/day) presented high morbidity with 70% of female and 100% of male rats being removed prior to the scheduled terminal sacrificed. Clinical findings suggested severe gastrointestinal symptoms, loss of body weight and unthrifty appearance among these animas, likely due to the bactericidal activity of silver ion on the intestinal microbiota. Significant lower mean body weight were observed in female rats administered of 100 and 400 of AgAc; the overall mean body weights were 88.5% and 74.4% of the control groups. Male rats administered with 400 and 200 mg/kg bw/d demonstrated significantly lower mean body weight than the controls, beginning at week 1 and week 3, respectively. body weight of male rats administered 100 mg/kg bw/d were not significantly affected. At the highest dose, the absolute heart and thymus weight were lower when compared with controls. Lourens et al. 2022 (NOAEL of 120 and 320 mg AgAc/ kg bw/day for males and females respectively) was assessed. However, the study was not selected as starting point to derive the DNEL for silver compounds because the NOAELs decribed in this study were considered not conservative enough. Therefore, it is the LOAEL of 40 mg AgAc/kg bw/day defined by the EOGRTS (F0 generation - exposed during 135 days (in total)) that was used as a starting point. For further details, please refer to separate report ""CSR Annex 2_Derivation of DNEL_2022"" which is attached to the CSR in section 13. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b7434d4-96ef-4c31-b114-e6fd7160a5d9/documents/c9f8c985-a54e-4aa1-a51e-8551ec5e6736_078a17f0-bdd5-4052-a2eb-6c0b4076ce80.html,,,,,, Silver chloride,7783-90-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b7434d4-96ef-4c31-b114-e6fd7160a5d9/documents/c9f8c985-a54e-4aa1-a51e-8551ec5e6736_078a17f0-bdd5-4052-a2eb-6c0b4076ce80.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat Silver chloride,7783-90-6,"A reliable study available for acute oral toxicity of silver chloride is available (rat, LD50 > 5510 mg/kg bw). Testing for acute inhalation toxicity is scientifically unjustified for AgCl (see respective justification for waiving). Testing for acute dermal toxicity is scientifically not justified for AgCl, because of the low potential for any dermal penetration (see section on toxicokinetics) and the generally low acute, systemic toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b7434d4-96ef-4c31-b114-e6fd7160a5d9/documents/IUC5-60078074-e716-4de8-ab85-c8642e8d7fb9_078a17f0-bdd5-4052-a2eb-6c0b4076ce80.html,,,,,, Silver nitrate,7761-88-8,"  A read-across approach from silver acetate (as source substance) is used for other silver compounds. The Toxicokinetic study confirmed the read-across between silver acetate and other silver compounds. For further details please refer to separate report ""CSR Annex 7 Read Across Justification Human Health_Nov 2022"" which is attached to the CSR in section 13. Key information considered: Lourens et al. 2022 performed a repeated dose toxicity (90-days) study according to OECD 408 and following GLP principles, with silver acetate administered via the diet to Wistar Han rats at 40, 120 and 320 mg/kg bw/day. Based on the results, the NOAEL was a target dose level of 120 mg/kg bw/day for males and a target dose of at least 320 mg/kg bw/day for female. Hadrup et al. 2012 conducted a subacute (28-day) oral toxicity study comparing the effects of silver acetate to those of nanoscale silver (see also below). Silver acetate was tested at only one dose (14 mg/kg bw/d, corresponding to 9 mg silver/kg bw/d) and in female rats only (for data on silver nanomaterials, see below). Oral exposure to silver in ionic form (as acetate) was reported by the authors to be associated with lower body weight gain, an increase in ALP and a decrease in urea concentrations in plasma and lower absolute and relative thymus weights. In lack of other more conclusive data, this study despite its limitations indicates a tentative LOEL for ionic silver of 9 mg/kg bw/d. Boudreau et al. 2016 conducted a 90-day (OECD 408) oral toxicity study.  Sprague Dawley rats of seven-week-old rats (10 rats per sex per group) were dosed with silver acetate (AgAc) at 100, 200, and 400 mg/kg bw; and controls (water). Rats exposed to AgAc at high dose (400 mg/kg bw/day) presented high morbidity with 70% of female and 100% of male rats being removed prior to the scheduled terminal sacrificed. Clinical findings suggested severe gastrointestinal symptoms, loss of body weight and unthrifty appearance among these animas, likely due to the bactericidal activity of silver ion on the intestinal microbiota. Significant lower mean body weight were observed in female rats administered of 100 and 400 of AgAc; the overall mean body weights were 88.5% and 74.4% of the control groups. Male rats administered with 400 and 200 mg/kg bw/d demonstrated significantly lower mean body weight than the controls, beginning at week 1 and week 3, respectively. body weight of male rats administered 100 mg/kg bw/d were not significantly affected. At the highest dose, the absolute heart and thymus weight were lower when compared with controls. Lourens et al. 2022 (NOAEL of 120 and 320 mg AgAc/ kg bw/day for males and females respectively) was assessed. However, the study was not selected as starting point to derive the DNEL for silver compounds because the NOAELs decribed in this study were considered not conservative enough. Therefore, it is the LOAEL of 40 mg AgAc/kg bw/day defined by the EOGRTS (F0 generation - exposed during 135 days (in total)) that was used as a starting point. For further details, please refer to separate report ""CSR Annex 2_Derivation of DNEL_2022"" which is attached to the CSR in section 13. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dbbb547a-cfab-4e57-a787-bf9c937ec5b0/documents/c9f8c985-a54e-4aa1-a51e-8551ec5e6736_31ee0ef8-7e19-4bd6-ab12-fd96e1f65250.html,,,,,, Silver nitrate,7761-88-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dbbb547a-cfab-4e57-a787-bf9c937ec5b0/documents/c9f8c985-a54e-4aa1-a51e-8551ec5e6736_31ee0ef8-7e19-4bd6-ab12-fd96e1f65250.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat Silver nitrate,7761-88-8,"The acute oral, dermal and inhalation toxicity studies have been waived in accordance with the column 2 of the Annex VII of REACh Regulation: the study does not need to be conducted as the substance is classified as corrosive to the skin (Category 1A). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbbb547a-cfab-4e57-a787-bf9c937ec5b0/documents/IUC5-ba9cc597-6df3-4f01-8d5e-23c4637ada9c_31ee0ef8-7e19-4bd6-ab12-fd96e1f65250.html,,,,,, Disilver oxide,20667-12-3,"  A read-across approach from silver acetate (as source substance) is used for other silver compounds. The Toxicokinetic study confirmed the read-across between silver acetate and other silver compounds. For further details please refer to separate report ""CSR Annex 7 Read Across Justification Human Health_Nov 2022"" which is attached to the CSR in section 13. Key information considered: Lourens et al. 2022 performed a repeated dose toxicity (90-days) study according to OECD 408 and following GLP principles, with silver acetate administered via the diet to Wistar Han rats at 40, 120 and 320 mg/kg bw/day. Based on the results, the NOAEL was a target dose level of 120 mg/kg bw/day for males and a target dose of at least 320 mg/kg bw/day for female. Hadrup et al. 2012 conducted a subacute (28-day) oral toxicity study comparing the effects of silver acetate to those of nanoscale silver (see also below). Silver acetate was tested at only one dose (14 mg/kg bw/d, corresponding to 9 mg silver/kg bw/d) and in female rats only (for data on silver nanomaterials, see below). Oral exposure to silver in ionic form (as acetate) was reported by the authors to be associated with lower body weight gain, an increase in ALP and a decrease in urea concentrations in plasma and lower absolute and relative thymus weights. In lack of other more conclusive data, this study despite its limitations indicates a tentative LOEL for ionic silver of 9 mg/kg bw/d. Boudreau et al. 2016 conducted a 90-day (OECD 408) oral toxicity study.  Sprague Dawley rats of seven-week-old rats (10 rats per sex per group) were dosed with silver acetate (AgAc) at 100, 200, and 400 mg/kg bw; and controls (water). Rats exposed to AgAc at high dose (400 mg/kg bw/day) presented high morbidity with 70% of female and 100% of male rats being removed prior to the scheduled terminal sacrificed. Clinical findings suggested severe gastrointestinal symptoms, loss of body weight and unthrifty appearance among these animas, likely due to the bactericidal activity of silver ion on the intestinal microbiota. Significant lower mean body weight were observed in female rats administered of 100 and 400 of AgAc; the overall mean body weights were 88.5% and 74.4% of the control groups. Male rats administered with 400 and 200 mg/kg bw/d demonstrated significantly lower mean body weight than the controls, beginning at week 1 and week 3, respectively. body weight of male rats administered 100 mg/kg bw/d were not significantly affected. At the highest dose, the absolute heart and thymus weight were lower when compared with controls. Lourens et al. 2022 (NOAEL of 120 and 320 mg AgAc/ kg bw/day for males and females respectively) was assessed. However, the study was not selected as starting point to derive the DNEL for silver compounds because the NOAELs decribed in this study were considered not conservative enough. Therefore, it is the LOAEL of 40 mg AgAc/kg bw/day defined by the EOGRTS (F0 generation - exposed during 135 days (in total)) that was used as a starting point. For further details, please refer to separate report ""CSR Annex 2_Derivation of DNEL_2022"" which is attached to the CSR in section 13. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ed64ceb-3dd9-4673-a715-18de6118cc43/documents/c9f8c985-a54e-4aa1-a51e-8551ec5e6736_3f5015c6-e229-4f7a-aeda-eb3a4e475caf.html,,,,,, Disilver oxide,20667-12-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ed64ceb-3dd9-4673-a715-18de6118cc43/documents/c9f8c985-a54e-4aa1-a51e-8551ec5e6736_3f5015c6-e229-4f7a-aeda-eb3a4e475caf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat Disilver oxide,20667-12-3,"Acute oral toxicity: A reliable in-vivo acute toxicity study performed via oral route (OECD 401 – GLP) is available, solid powder of Ag2O (purity 93% of Ag) (Mayr, W et al. 1989). The study concluded that disilver oxide is not acute toxic via oral route. The LD50 was defined by the author at > 3804 mg/kg bw. Acute inhalation toxicity: The conduct of an acute inhalation study with disilver oxide is technically not feasible as shown in a feasibility test (Leuschner, 2010). Moreover, the study does not need to be conducted because exposure of humans via inhalation route is not likely to occur. The vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size limits the inhalation exposure. Acute dermal toxicity: The physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin (poorly water soluble). Moreover, the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route (LD50 >3804 mg/kg bw) and no systemic effects have been observed in in-vivo studies with dermal exposure (nor skin irritant neither skin sensitizer). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): good quality of the whole database ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ed64ceb-3dd9-4673-a715-18de6118cc43/documents/IUC5-9857086c-9112-463e-a03b-c36190cd45bd_3f5015c6-e229-4f7a-aeda-eb3a4e475caf.html,,,,,, Disilver oxide,20667-12-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ed64ceb-3dd9-4673-a715-18de6118cc43/documents/IUC5-9857086c-9112-463e-a03b-c36190cd45bd_3f5015c6-e229-4f7a-aeda-eb3a4e475caf.html,,oral,LD50,"3,804 mg/kg bw",no adverse effect observed, Disilver(1+) sulphate,10294-26-5,"A reliable study available for acute oral toxicity of silver(I)sulfate is available (rat, LD50 > 5000 mg/kg bw). Similar acute oral toxicity studies with other silver substances, which all indicate low acute oral toxicity, are included in this dossier for comparative reasons. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f8047d0-a49b-495e-87f7-1d8a5fb3a158/documents/IUC5-159b0970-d040-47e2-8f0e-e417bce320bb_256b31ed-754d-4173-86af-3c654d57297b.html,,,,,, Disilver(1+) sulphate,10294-26-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f8047d0-a49b-495e-87f7-1d8a5fb3a158/documents/IUC5-159b0970-d040-47e2-8f0e-e417bce320bb_256b31ed-754d-4173-86af-3c654d57297b.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "Silybum marianum, ext.",84604-20-6," Under the experimental conditions of the study, due to the test item limit of solubility (i.e. 100 μg/mL in DMEM0 containing 0.5% ethanol) and the fact that no cytotoxicity was achieved after the preliminary test, this study was stopped at this stage. It was not possible to derive any IC50 and therefore any LD50. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e51d4bca-0a60-4ec5-835e-212d6017424d/documents/c1178ee3-16f5-4d9c-b0e1-1aa71e0bd61c_c9d74b08-1256-4d68-9947-8cd0a259c563.html,,,,,, Zinc carbonate,3486-35-9,"Non-human informationThe repeated dose toxicity of water soluble zinc sulphate and zinc monoglycerolate has been examined in a total of 3 subchronic oral feeding studies. Due to the different dosing regimens, the lowest NOAEL was determined to be 31.5 mg/kg bw/day of zinc monoglycerolate which equals a total zinc exposure of approximate 13 mg/kg bw/day. The zinc NOAEL derived from the feeding studies with zinc sulphate was determined to be 104 mg Zn/kg bw/day in mice and approximately 53.5 mg/kg bw/day in rats. At higher doses the most important effects in the rats were the development of hypocupremia, and significant changes in the pancreas (i.e., focal acinar degeneration and necrosis) and a decreased number of pigmented macrophages in spleen.No longer term inhalation studies allowing to derive a robust NOEL for the inhalatory exposure of the respective zinc compounds has been identified. In a short term 3-day inhalation study with guinea pigs, a concentration of 2.3 mg ultrafine ZnO/m3 (3 hours/day) resulted in changes in neutrophils and activities of lactate dehydrogenase and alkaline phosphatase in the pulmonary fluid. At higher concentrations increased protein concentration, neutrophils, and enzyme activities in lung lavage fluids were seen, together with significant centriacinar inflammation of the pulmonary tissue. Inhalatory doses of 2.7 mg ultrafine ZnO/m3 for 5 days 3hours/day did not alter the lung function parameters in guinea pigs, but at 5 and 7 mg ultrafine ZnO/m3 exposure according to a similar pattern, a gradual decrease in total lung capacity, vital capacity and reduction of the carbon monoxide diffusing capacity was seen in combination with inflammatory changes and edema. The relevance of the findings in studies with ultra-fine zinc oxide fumes is unclear with respect to commercial grade zinc oxide, as the latter is of much larger particle size and can have different toxicological characteristics. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8454137-904d-4be8-8816-83afa10420e2/documents/4e3b49a6-d65d-4c29-97cf-2fcfdddcb4aa_d212b043-c175-4d24-a918-7fa57a8db1d1.html,,,,,, Zinc carbonate,3486-35-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8454137-904d-4be8-8816-83afa10420e2/documents/4e3b49a6-d65d-4c29-97cf-2fcfdddcb4aa_d212b043-c175-4d24-a918-7fa57a8db1d1.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,2.7 mg/m3,,guinea pig Zinc carbonate,3486-35-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8454137-904d-4be8-8816-83afa10420e2/documents/4e3b49a6-d65d-4c29-97cf-2fcfdddcb4aa_d212b043-c175-4d24-a918-7fa57a8db1d1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,13.3 mg/kg bw/day,,rat Zinc carbonate,3486-35-9,Acute oral toxicity: key study carried out according to OECD guideline no 401 indicating for zinc oxide LD50 > 5000 mg/kg bw (read across to zinc carbonateAcute inhalation toxicity: key study carried out according to OECD guideline no 403 indicating for zinc oxide LC50 > 5.7 mg/L/4hrs (read-across to zinc carbonate ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8454137-904d-4be8-8816-83afa10420e2/documents/ddaa34f9-9632-4199-b668-d87a68c0f39f_d212b043-c175-4d24-a918-7fa57a8db1d1.html,,,,,, Zinc carbonate,3486-35-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8454137-904d-4be8-8816-83afa10420e2/documents/ddaa34f9-9632-4199-b668-d87a68c0f39f_d212b043-c175-4d24-a918-7fa57a8db1d1.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Zinc carbonate,3486-35-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8454137-904d-4be8-8816-83afa10420e2/documents/ddaa34f9-9632-4199-b668-d87a68c0f39f_d212b043-c175-4d24-a918-7fa57a8db1d1.html,,dermal,LD50,"2,000 mg/kg bw",, Zinc carbonate,3486-35-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8454137-904d-4be8-8816-83afa10420e2/documents/ddaa34f9-9632-4199-b668-d87a68c0f39f_d212b043-c175-4d24-a918-7fa57a8db1d1.html,,inhalation,LC50,"5,700 mg/m3",no adverse effect observed, Sodium 3-mercaptopropanesulphonate,17636-10-1,"Due to the high structural similarity, similarity in organic functional groups, physico-chemical properties and similarity in reactivity to biomolecules, mesna (CAS 19767-45-4) is considered to be the most suitable chemical for read-across. Mesna did not produce any signs of toxicity in treated animals in two-year carcinogenicity study and therefore the dose of 350 mg/kg bw is considered to be a NOAEL. No C&L for systemic organ toxicity (STOT-RE) is required. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aff4fa9a-58de-4ca8-b4e3-80be7c45e60f/documents/IUC5-23ce9f33-e661-4f54-9d67-1def3d4e8451_dbed9427-9a6b-4c48-a37d-b20849d7ffab.html,,,,,, Sodium 3-mercaptopropanesulphonate,17636-10-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aff4fa9a-58de-4ca8-b4e3-80be7c45e60f/documents/IUC5-23ce9f33-e661-4f54-9d67-1def3d4e8451_dbed9427-9a6b-4c48-a37d-b20849d7ffab.html,Chronic toxicity – systemic effects,oral,NOAEL,350 mg/kg bw/day,,rat Sodium 3-mercaptopropanesulphonate,17636-10-1,"1. Acute oral toxicity (1987), GLP, OECD 401, rats, gavage, 2500 mg/kg, 3180 mg/kg, 4000 mg/kg, 5000 mg/kg, LD50 3720 mg/kg bw (14 day survival), 4110 mg/kg bw (24 hour survival). 2. Acute dermal toxicity (1987), GLP, OECD 402, rats, semiocclusive, 2.5 g/kg, 5.0 g/kg, 7.5 g/kg, LD50 > 7.5 g/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aff4fa9a-58de-4ca8-b4e3-80be7c45e60f/documents/IUC5-5c38a606-f2a2-4941-b37d-a68659df922d_dbed9427-9a6b-4c48-a37d-b20849d7ffab.html,,,,,, Sodium 3-mercaptopropanesulphonate,17636-10-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aff4fa9a-58de-4ca8-b4e3-80be7c45e60f/documents/IUC5-5c38a606-f2a2-4941-b37d-a68659df922d_dbed9427-9a6b-4c48-a37d-b20849d7ffab.html,,oral,LD50,"3,720 mg/kg bw",no adverse effect observed, Sodium 3-mercaptopropanesulphonate,17636-10-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aff4fa9a-58de-4ca8-b4e3-80be7c45e60f/documents/IUC5-5c38a606-f2a2-4941-b37d-a68659df922d_dbed9427-9a6b-4c48-a37d-b20849d7ffab.html,,dermal,LD50,"7,500 mg/kg bw",no adverse effect observed, Sodium acetate,127-09-3,"Repeated dose toxicity: oral:Weight of evidence. Experimental results from no-standard studies on rats with Sodium Acetate and Citric acid, sodium salt. All these studies showed no signs of toxicity, eventhough in one study, exceeding the limit dose. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c012f035-86e0-4867-989e-a4baa63b0c61/documents/IUC5-adc92f7e-e012-46bf-821d-a97e3bccc06a_5ef34666-79dc-4263-ab6c-43f375ea3dfc.html,,,,,, Sodium acetate,127-09-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c012f035-86e0-4867-989e-a4baa63b0c61/documents/IUC5-adc92f7e-e012-46bf-821d-a97e3bccc06a_5ef34666-79dc-4263-ab6c-43f375ea3dfc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"3,600 mg/kg bw/day",,rat Sodium acetate,127-09-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c012f035-86e0-4867-989e-a4baa63b0c61/documents/IUC5-8c794482-ccff-4d05-b9a5-77f0c1c53b2a_5ef34666-79dc-4263-ab6c-43f375ea3dfc.html,,oral,LD50,"2,720 mg/kg bw",, Sodium acetate,127-09-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c012f035-86e0-4867-989e-a4baa63b0c61/documents/IUC5-8c794482-ccff-4d05-b9a5-77f0c1c53b2a_5ef34666-79dc-4263-ab6c-43f375ea3dfc.html,,dermal,LD50,"28,269.15 mg/kg bw",, Sodium acetate,127-09-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c012f035-86e0-4867-989e-a4baa63b0c61/documents/IUC5-8c794482-ccff-4d05-b9a5-77f0c1c53b2a_5ef34666-79dc-4263-ab6c-43f375ea3dfc.html,,inhalation,LC50,"5,810 mg/m3",, Aluminium sodium dioxide,1302-42-7,"Based on read-acrossOral: NOAEL (chronic, rat) 322.5 mg/kg bw/day of aluminium citrate (equivalent to 30 mg Al/kg bw/day) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2b5158a-e681-4ff3-a371-7c411e315a52/documents/IUC5-81671931-23da-453c-a8bd-e90fcd584341_9b07b6fb-f53c-4011-8acb-17af3928ae5c.html,,,,,, Aluminium sodium dioxide,1302-42-7,"Sodium aluminate is corrosive to the skin and mucous membranes. Acute toxicity data is based on information from aluminium and aluminium compounds as structural analogues for read-across.Oral: LD50 > 2000 mg/kg bw (aluminium oxide, nanosized and bulk material)Inhalation: LC50 > 1000 mg Al/m³ air (aluminium flakes)Inhalation: LC50 > 5090 mg Al/m³ air (75% aluminium oxide, 25% aluminium hydroxide) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2b5158a-e681-4ff3-a371-7c411e315a52/documents/IUC5-60a71dda-7501-4318-9e76-e3882778d42b_9b07b6fb-f53c-4011-8acb-17af3928ae5c.html,,,,,, Sodium anisate,536-45-8," short-term repeated dose toxicity OECD 422, oral, rat: systemic NOAEL 500 mg/kg bw/day (highest dose tested) Read-across from anisaldehyde (CAS 123-11-5) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8754f759-5310-4cc4-a96e-497d8b6db585/documents/c39f750b-6f60-443b-8d66-289ff3fc3df4_6d3134ef-94e8-425e-a5be-24f460c97d72.html,,,,,, Sodium anisate,536-45-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8754f759-5310-4cc4-a96e-497d8b6db585/documents/c39f750b-6f60-443b-8d66-289ff3fc3df4_6d3134ef-94e8-425e-a5be-24f460c97d72.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Sodium anisate,536-45-8," Oral (equivalent or similar to OECD 401), rat: LD50 > 5000 mg/kg bw Read-across from p-anisic acid (CAS 100-09-4) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8754f759-5310-4cc4-a96e-497d8b6db585/documents/778f9c5c-d0d0-4805-9fdd-dbffbc380715_6d3134ef-94e8-425e-a5be-24f460c97d72.html,,,,,, Sodium anisate,536-45-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8754f759-5310-4cc4-a96e-497d8b6db585/documents/778f9c5c-d0d0-4805-9fdd-dbffbc380715_6d3134ef-94e8-425e-a5be-24f460c97d72.html,,oral,LD50,"5,000 mg/kg bw",adverse effect observed, Sodium ascorbate,134-03-2, The NOAEL of the substance was determined to be 4500 mg sodium ascorbate /kg bw and day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/102dde58-4e3f-4444-8445-a20a5b0ace9c/documents/9d39b3d4-1052-4d8b-b9a2-fea85b41a47b_14d3ca44-ff40-4299-a2f8-e5442d17e1ca.html,,,,,, Sodium ascorbate,134-03-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/102dde58-4e3f-4444-8445-a20a5b0ace9c/documents/9d39b3d4-1052-4d8b-b9a2-fea85b41a47b_14d3ca44-ff40-4299-a2f8-e5442d17e1ca.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"4,500 mg/kg bw/day",,rat Sodium ascorbate,134-03-2," The acute toxicity was investigated in 5 studies, 3 using rats and 2 using mice that received either a single dose or were treated on five consecutive days. No signs of toxicity were seen in any of the studies. The LD50 values were > 11,000 mg/kg bw in the rat and > 9,400 mg/kg bw in the mouse. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/102dde58-4e3f-4444-8445-a20a5b0ace9c/documents/1019d636-9c27-45b1-8b81-823bdc1adfac_14d3ca44-ff40-4299-a2f8-e5442d17e1ca.html,,,,,, Sodium ascorbate,134-03-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/102dde58-4e3f-4444-8445-a20a5b0ace9c/documents/1019d636-9c27-45b1-8b81-823bdc1adfac_14d3ca44-ff40-4299-a2f8-e5442d17e1ca.html,,oral,LD50,"11,000 mg/kg bw",no adverse effect observed, Sodium hydrogen L-aspartate,3792-50-5,The acute oral LD50 was determined to be > 2000 mg/kg bw in rats (reference 7.2.1-1). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1f1763b-0002-4cef-bfce-4be83df5448f/documents/d215d24d-6256-42bd-9cc1-c87d9de2f567_e453e4dd-6f18-495a-af46-82f24cfcd307.html,,,,,, Sodium hydrogen L-aspartate,3792-50-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1f1763b-0002-4cef-bfce-4be83df5448f/documents/d215d24d-6256-42bd-9cc1-c87d9de2f567_e453e4dd-6f18-495a-af46-82f24cfcd307.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Sodium benzoate,532-32-1,"Oral:The studies available are feeding studies in rat and mice (one drinking water study in mice). Mice seem to be less susceptible to the effects of the test substance than rats. Effects are severe decrease of body weight with effects in the liver. The no effect level is 2% in the diet of rats. In the reports available different conversion methods are used to calculate the actual test substance intake. This may have been done by actual measurement of food intake, but is not clearly described in the publications. Therefore a calculation was done based on the factors as described in the WHO report (EHS Environmental Health Criteria 240). This leads to a NOAEL of 1000 mg/kg bw based on the 2% dietary level in rats.In a chronic toxicity/carcinogenicity study in rats (Sodemoto, 1979) no signs of toxicity were reported at 2% the test substance in feed (stated to be equivalent to 1000 mg/kg bw). In mice (Toth, 1984) no effects were reported at 2% the test substance in drinking water (119-124 mg/animal/day).Dermal: An repeated dermal toxicity study with rabbit (Marroquin, 1981) which run on analog substance Benzoic acid (65-85-0) is available which is key study.The NOAEL was > 2500 mg/kg bodyweight.Inhalation: A study is available with a NOAEL of the key study of 250 mg/m3 (Benson, 1981). These findings were primarily attributed to the physico-chemical properties of these fine low-solubility particles. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62229e3b-dd55-4ddd-a0ac-7c13b4842c65/documents/IUC5-e8cabd51-1fd0-4ba7-9e90-e143b5e79057_a107934c-f369-41b9-80bc-cf31d91e24b0.html,,,,,, Sodium benzoate,532-32-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62229e3b-dd55-4ddd-a0ac-7c13b4842c65/documents/IUC5-e8cabd51-1fd0-4ba7-9e90-e143b5e79057_a107934c-f369-41b9-80bc-cf31d91e24b0.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,500 mg/kg bw/day",,rabbit Sodium benzoate,532-32-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62229e3b-dd55-4ddd-a0ac-7c13b4842c65/documents/IUC5-e8cabd51-1fd0-4ba7-9e90-e143b5e79057_a107934c-f369-41b9-80bc-cf31d91e24b0.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,250 mg/m3,,rat Sodium benzoate,532-32-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62229e3b-dd55-4ddd-a0ac-7c13b4842c65/documents/IUC5-e8cabd51-1fd0-4ba7-9e90-e143b5e79057_a107934c-f369-41b9-80bc-cf31d91e24b0.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium benzoate,532-32-1,"Oral: Multiple studies are available with a LD50 value of >2000 mg/kg in a weight of evidence approach.Dermal: An acute dermal toxicity study with rabbit (Goldenthal, 1974) which run on analog substance Benzoic acid (65-85-0) is available which is key study. The LD50 was >2000 mg/kg bodyweight.Inhalation: An acute inhalation toxicity study with rat (Goldenthal, 1974) which run on analog substance Benzoic acid (65-85-0) is available which is key study. The LC50 was >12200 mg/m3. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62229e3b-dd55-4ddd-a0ac-7c13b4842c65/documents/IUC5-2b4c8725-4974-48f4-a3f2-214329f8bba8_a107934c-f369-41b9-80bc-cf31d91e24b0.html,,,,,, Sodium benzoate,532-32-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62229e3b-dd55-4ddd-a0ac-7c13b4842c65/documents/IUC5-2b4c8725-4974-48f4-a3f2-214329f8bba8_a107934c-f369-41b9-80bc-cf31d91e24b0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium benzoate,532-32-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62229e3b-dd55-4ddd-a0ac-7c13b4842c65/documents/IUC5-2b4c8725-4974-48f4-a3f2-214329f8bba8_a107934c-f369-41b9-80bc-cf31d91e24b0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium benzoate,532-32-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62229e3b-dd55-4ddd-a0ac-7c13b4842c65/documents/IUC5-2b4c8725-4974-48f4-a3f2-214329f8bba8_a107934c-f369-41b9-80bc-cf31d91e24b0.html,,inhalation,LC50,"12,200 mg/m3",no adverse effect observed, Sodium hydrogencarbonate,144-55-8," A number of studies are available in which the toxicity of sodium hydrogencarbonate following repeated exposure is examined. Nevertheless, none of these studies is performed in line with recent guidelines, nor was it possible to derive a NOAEL from the data. Nevertheless, in accordance with section 1 of REACH Annex XI, a chronic repeated dose toxicity study on sodium hydrogencarbonate is considered scientifically unjustified because sodium and hydrogencarbonate ions are ubiquitous in living organisms, and both have important roles in the physiology of normal cell functioning. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0a1d857-9bf6-4eac-ab33-e72be7a6e4d7/documents/IUC5-de04bb72-8cef-4472-8597-b8a6e195d89c_440899ee-ab4f-4972-88ed-4b2278e64f51.html,,,,,, Sodium hydrogencarbonate,144-55-8, Oral LD50 > 4000 mg/kg bw/d. Inhalation LC50 > 4.74 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0a1d857-9bf6-4eac-ab33-e72be7a6e4d7/documents/IUC5-588689d2-8240-431d-8d36-4d0d248df78d_440899ee-ab4f-4972-88ed-4b2278e64f51.html,,,,,, Sodium hydrogensulphate,7681-38-1,"No data specifically for sodium hydrogensulfate on repeated dose toxicity are available, thus read-across to sodium sulfate was performed. In a sub-acute oral toxicity study with sodium sulfate no adverse effects were noted, and the NOAEL (oral, rat) was established at 1000 mg/kg bw/day (Ceccatelli R., 2010 OECD 421 Main Study C79103). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f3d6838-807e-47f7-940f-54c0b270d8a1/documents/IUC5-173f318b-f513-442d-a91f-3a9f2b83a0c1_7186fad8-17ca-470a-96d2-30f3153dae7a.html,,,,,, Sodium hydrogensulphate,7681-38-1,"Test results are available for sodium sulfate and sulfuric acid for acute toxicity rat (oral and inhalation).Sodium sulfate:LC50, 4h (rat, inhalation) > 2400 mg/m3 airLCLo,72h (rat, inhalation) > 10 mg/m3 airLD50 (rat,oral) > 2000 mg/kg bw (Areclin) LD50 (rat, oral) > 10 g/kg bw (Henkel) Sulfuric acid:LD50 2140 mg/kg bwBased on the results of several acute toxicity inhalation studies for sodium sulafte it is unlikely that short-term inhalation of respirable sodium sulfate particles cause pulmonary irritation or systemic effects; The acute dermal toxicity (rat) is waived: Annex XI adaptation- inorganic ionic substance low potential for absorption through the skin. Based on the assumption described in the read-across concept, read-across from sodium sulfate and sulfuric acid to sodium hydrogensulfate is considered justified. Threfore it can be concluded that sodium hydrogensulfate has no acute-toxic propoerties. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f3d6838-807e-47f7-940f-54c0b270d8a1/documents/IUC5-cbef4c47-1d0e-44f1-a7ec-aed5c373c021_7186fad8-17ca-470a-96d2-30f3153dae7a.html,,,,,, Sodium hydrogensulfite,7631-90-5,"A 3-generation chronic toxicity study (Til et al. 1972a) with treatment of rats (20 per sex and group) with dose levels of 0, 0.125, 0.25, 0.5, 1.0 or 2.0% Na2S2O5 administered in a 50 ppm thiamine-containing diet was identified as most reliable study for repeated dose toxicity and was defined as key study (read-across info, see `discussion`). Based on the read across concept for the group of sulfite substances, this result is also applicable to sodium hydrogensulfite. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/87c6badd-5921-4442-a4d9-bddebb81ff01/documents/IUC5-a9bddb9e-a43c-45a8-aa48-d193fc5118c1_f33cd5b7-f493-492e-99ef-66be1d91a452.html,,,,,, Sodium hydrogensulfite,7631-90-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/87c6badd-5921-4442-a4d9-bddebb81ff01/documents/IUC5-a9bddb9e-a43c-45a8-aa48-d193fc5118c1_f33cd5b7-f493-492e-99ef-66be1d91a452.html,Chronic toxicity – systemic effects,oral,NOAEL,118 mg/kg bw/day,,rat Sodium hydrogensulfite,7631-90-5,"Based on the described read-across methodology information from sodium sulfite (CAS 7757-83-7), sodium metabisulfite (CAS 7681 -57 -4) and potassium metabisulfite (CAS 16731 -55 -8) were used to determine acute toxicity values (oral, dermal and inhalative) for sodium hydrogensulfite.Please see `discussion` below. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87c6badd-5921-4442-a4d9-bddebb81ff01/documents/IUC5-5dae16d6-eaa7-4b62-ad92-b9f9d7cb0088_f33cd5b7-f493-492e-99ef-66be1d91a452.html,,,,,, "Disodium tetraborate, anhydrous",1330-43-4,"A number of sub-chronic and chronic studies on boric acid and disodium tetraborate decahydrate were carried out in rats, mice and dogs. In some cases these studies are research studies (Dixon et al, 1976; Seal and Weeth, 1980; Lee et al., 1978; Treinen and Chapin, 1991; Ku et al., 1993), but most support that boron can cause adverse haematological effects and that the main target organ of boron toxicity is the testis. The NOAEL for fertility effects is equivalent to 17.5 mg B/kg bw/day that corresponds to NOAEL of 81.4 mg disodium tetraborate /kg bw (Weir, 1966). The key developmental study provides BMDL05 which is based on results of two studies and therefore is more accurate and more precise than NOAEL established in one study. The oral BMDL05 has been extrapolated to inhalation BMCL05 of 84.5 mg/m³ for disodium tetraborate anhydrous by route-to-route extrapolation (see section ""DNEL derivation"").  ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a58db1d7-5147-42b2-91f7-f895262645a7/documents/649ea929-a161-4e4b-807a-986230c88074_796d75c8-dd72-4324-9590-f1a5f8348f9a.html,,,,,, "Disodium tetraborate, anhydrous",1330-43-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a58db1d7-5147-42b2-91f7-f895262645a7/documents/649ea929-a161-4e4b-807a-986230c88074_796d75c8-dd72-4324-9590-f1a5f8348f9a.html,Short-term repeated dose toxicity – systemic effects,inhalation,BMCL05,84.5 mg/m3,, "Disodium tetraborate, anhydrous",1330-43-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a58db1d7-5147-42b2-91f7-f895262645a7/documents/649ea929-a161-4e4b-807a-986230c88074_796d75c8-dd72-4324-9590-f1a5f8348f9a.html,Chronic toxicity – systemic effects,oral,NOAEL,81.4 mg/kg bw/day,,rat "Disodium tetraborate, anhydrous",1330-43-4," Acute oral studies have been performed with disodium tetraborate anhydrous, disodium tetraborate pentahydrate and disodium tetraborate decahydrate. Acute dermal and inhalation studies have been performed with disodium tetraborate pentahydrate and disodium tetraborate decahydrate. Experimental data showed low acute toxicity to disodium tetraborates. LD50 values of >2000 mg/kg were recorded for both oral and dermal routes and > 2 mg/L for the acute inhalation route. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a58db1d7-5147-42b2-91f7-f895262645a7/documents/147f8347-6979-4a7a-a0b9-34a684d9b61a_796d75c8-dd72-4324-9590-f1a5f8348f9a.html,,,,,, "Disodium tetraborate, anhydrous",1330-43-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a58db1d7-5147-42b2-91f7-f895262645a7/documents/147f8347-6979-4a7a-a0b9-34a684d9b61a_796d75c8-dd72-4324-9590-f1a5f8348f9a.html,,oral,LD50,"> 2,500 mg/kg bw",no adverse effect observed, "Disodium tetraborate, anhydrous",1330-43-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a58db1d7-5147-42b2-91f7-f895262645a7/documents/147f8347-6979-4a7a-a0b9-34a684d9b61a_796d75c8-dd72-4324-9590-f1a5f8348f9a.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Disodium tetraborate, anhydrous",1330-43-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a58db1d7-5147-42b2-91f7-f895262645a7/documents/147f8347-6979-4a7a-a0b9-34a684d9b61a_796d75c8-dd72-4324-9590-f1a5f8348f9a.html,,inhalation,LC50,> 2 mg/L,no adverse effect observed, Sodium (2-butoxyethoxy)acetate,67990-17-4," In an acute oral toxicity study in rats according to OECD Guideline 423, the determined LD50 was above 2000 mg/kg bw. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84b7631b-bf34-47aa-af68-2bbd9e4b4d9a/documents/888bfd4d-acf0-4e01-80e4-33acf9ac4a7c_efb01d38-d2c7-4ada-a1d2-67f0dd91d395.html,,,,,, Sodium (2-butoxyethoxy)acetate,67990-17-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84b7631b-bf34-47aa-af68-2bbd9e4b4d9a/documents/888bfd4d-acf0-4e01-80e4-33acf9ac4a7c_efb01d38-d2c7-4ada-a1d2-67f0dd91d395.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts",68411-30-3,- Oral: The NOAEL was 85 mg/kg bw/day in rats (WoE). - Dermal: The NOAEL was 2500 mg/kg bw/day in rats. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5db3852e-93e5-4ed3-874b-20efbbcd386f/documents/869e71ce-acc8-4c31-8352-c862be0b0bcc_722dcdca-8b57-45a3-9b05-1cc94cab4584.html,,,,,, "Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts",68411-30-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5db3852e-93e5-4ed3-874b-20efbbcd386f/documents/869e71ce-acc8-4c31-8352-c862be0b0bcc_722dcdca-8b57-45a3-9b05-1cc94cab4584.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,85 mg/kg bw/day,,rat "Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts",68411-30-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5db3852e-93e5-4ed3-874b-20efbbcd386f/documents/869e71ce-acc8-4c31-8352-c862be0b0bcc_722dcdca-8b57-45a3-9b05-1cc94cab4584.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,500 mg/kg bw/day",,rat "Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts",68411-30-3,"The key study examined the oral toxicity of the test substance in rats. Groups of 5 male and 5 female rats were exposed orally via gavage to 0, 1075, 1220, 1360, or 1710 mg/kg of test substance (all doses reported were adjusted from the original for 86% activity). The animals were then monitored for 14 days for mortality and clinical signs. Body weights were measured on days 7 and 14, and necropsies were performed at the end of the study. No effects on body weight were observed, but all animals showed some signs of toxicity. Symptoms beginning about 30 minutes past application included diarrhea, squatting attitude, breathing difficulties, nose bleeding, ataxia, and lethargy. These symptoms had disappeared in surviving animals by 120 hours. In the animals that died before the end of the study, red mucous was seen in the stomach and intestine. In the surviving animals, hyperemia of the stomach was noted, along with abnormalities of the stomach, liver, spleen, kidneys, and the peritoneum. Mortality was seen at all dose levels, with 4 of 10 animals at the lowest dose level dying. All animals at the highest dose level died. The acute oral LD50, when adjusted for active content was 1080 mg/kg. According to EU GHS guidelines, the test substance is a Category IV toxicant.   No study is required for inhalation exposure (data waiving). In accordance with column 2 of REACH Annex VIII-X, in addition to the oral route, for substances other than gases, an acute toxicity study for at least one other route is required. The choice of the second route will depend on the nature of the substance and the likely route of human exposure. As dermal is the most likely route of exposure and acute dermal toxicity data are available, no data gap for inhalation exposure exists. Dermal toxicity was examined in a study on LAS. The clipped skin on the backs (approximate 10% of the area) of five male and five female rats were exposed to a dose of 2000 mg/kg LAS and kept under an occlusive dressing for 24 hours, then observed for another 14 days after the dressing was removed and the skin washed in warm water. The treated areas were examined daily for signs of dermal irritation and assessed according to the standard scoring system for erythema, eschar and oedema. On day 15 all animals were sacrificed and given a macroscopic post-mortem examination of internal organs. No mortality was observed at exposures to 2000 mg/kg of the undiluted test material. There were no signs of systemic reaction. Well defined or slight erythema and slight oedema were observed at all test sites after removal of the occlusive dressings, and these reactions were unresolved before progressive hardening of the skin was first detected on day 4. All test sites were entirely covered by scab formation from day 7. Sloughing from the scabbed skin began at various times between day 7 and day 12 and was completed before test termination. Therefore, results indicate slight erythema and slight oedema but no acute mortality. The dermal LD50 is > 2000 mg/kg and LAS is not classified for acute dermal toxicity under CLP.   The acute toxicity of LAS was examined via both the oral and dermal routes of exposure. In the oral exposure study, mortality was seen at all dose levels and the resulting acute oral LD50was 1080 mg/kg. In addition, all animals showed some signs of toxicity, with symptoms including diarrhea, squatting attitude, breathing difficulties, nose bleeding, ataxia, and lethargy, though all of these symptoms had disappeared in surviving animals by 120 hours. In the surviving animals, hyperemia of the stomach was noted, along with abnormalities of the stomach, liver, spleen, kidneys, and the peritoneum. Additional acute oral studies were conducted on various concentrations of LAS. The acute oral LD50’s determined for the concentrations were 1600 mg/kg, 2190 mg/kg and 2760 mg/kg for 75%, 65% and 60% actives, respectively. In the dermal test, no mortality was seen at exposures to 2000 mg/kg of undiluted LAS and no other signs of systemic reactions were observed. However, well defined or slight erythema and slight oedema were observed at all test sites immediately after removal of the occlusive dressings, and these reactions were unresolved before progressive hardening of the skin was first detected on day 4. All test sites were entirely covered by scab formation from day 7, and complete sloughing from the scabbed skin was completed before test termination. Therefore, results indicate slight erythema and slight oedema but no acute mortality from dermal exposures, with a dermal LD50of > 2000 mg/kg. According to CLP Regulation, the test substance is a Category IV toxicant based on the oral toxicity testing results. No classification is necessary for dermal exposures. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5db3852e-93e5-4ed3-874b-20efbbcd386f/documents/865c5fff-4281-4641-a454-99b0fa3158d4_722dcdca-8b57-45a3-9b05-1cc94cab4584.html,,,,,, "Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts",68411-30-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5db3852e-93e5-4ed3-874b-20efbbcd386f/documents/865c5fff-4281-4641-a454-99b0fa3158d4_722dcdca-8b57-45a3-9b05-1cc94cab4584.html,,oral,LD50,"1,080 mg/kg bw",adverse effect observed, "Benzenesulfonic acid, C10-13-alkyl derivs., sodium salts",68411-30-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5db3852e-93e5-4ed3-874b-20efbbcd386f/documents/865c5fff-4281-4641-a454-99b0fa3158d4_722dcdca-8b57-45a3-9b05-1cc94cab4584.html,,dermal,LD50,"2,000 mg/kg bw",, "Sulfuric acid, mono-C12-18-alkyl esters, sodium salts",68955-19-1,For the whole category of alkyl sulfates (AS) a NOAEL of 488 mg/kg bw/day for oral and dermal exposure was established. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07fcc44c-f6e2-4c55-802d-431d6bf06c57/documents/IUC5-59937977-a475-44c7-a320-007b64e2d655_8f305840-2a11-481e-9010-ee7355e6ebc2.html,,,,,, "Sulfuric acid, mono-C12-18-alkyl esters, sodium salts",68955-19-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07fcc44c-f6e2-4c55-802d-431d6bf06c57/documents/IUC5-59937977-a475-44c7-a320-007b64e2d655_8f305840-2a11-481e-9010-ee7355e6ebc2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,488 mg/kg bw/day,,rat "Sulfuric acid, mono-C12-18-alkyl esters, sodium salts",68955-19-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07fcc44c-f6e2-4c55-802d-431d6bf06c57/documents/IUC5-59937977-a475-44c7-a320-007b64e2d655_8f305840-2a11-481e-9010-ee7355e6ebc2.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,,mouse "Sulfuric acid, mono-C12-18-alkyl esters, sodium salts",68955-19-1,"Oral LD50 (OECD guideline 401), rat = 4010 mg/kg bwDermal LD50 (OECD guideline 402), rabbit > 2000 mg/kg bw (limit test) Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07fcc44c-f6e2-4c55-802d-431d6bf06c57/documents/IUC5-f7ec7679-d1dd-41bb-8ae1-70e841ef1692_8f305840-2a11-481e-9010-ee7355e6ebc2.html,,,,,, "Sulfuric acid, mono-C12-18-alkyl esters, sodium salts",68955-19-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07fcc44c-f6e2-4c55-802d-431d6bf06c57/documents/IUC5-f7ec7679-d1dd-41bb-8ae1-70e841ef1692_8f305840-2a11-481e-9010-ee7355e6ebc2.html,,oral,LD50,"4,010 mg/kg bw",no adverse effect observed, "Sulfuric acid, mono-C12-18-alkyl esters, sodium salts",68955-19-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07fcc44c-f6e2-4c55-802d-431d6bf06c57/documents/IUC5-f7ec7679-d1dd-41bb-8ae1-70e841ef1692_8f305840-2a11-481e-9010-ee7355e6ebc2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts",68439-57-6,"NOAEL oral, rat, 2-year feeding: ≥ 195 mg/kg bw/d (males); ≥ 259 mg/kg bw/d (females) Waiver repeated dose toxicity: dermal Waiver repeated dose toxicity: inhalation ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/685e7f37-2224-44bf-80dc-e9fbb60b4c13/documents/IUC5-438042a7-774f-463e-a48c-6330bbe0552c_287edebb-80e3-4a2d-9cd8-9dfcb12e0853.html,,,,,, "Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts",68439-57-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/685e7f37-2224-44bf-80dc-e9fbb60b4c13/documents/IUC5-438042a7-774f-463e-a48c-6330bbe0552c_287edebb-80e3-4a2d-9cd8-9dfcb12e0853.html,Chronic toxicity – systemic effects,oral,NOAEL,259 mg/kg bw/day,,rat "Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts",68439-57-6,oral: OECD 401: LD50 rat = 2079 mg/kg bwdermal: comparable to OECD 402: LD50 rabbit = 6300 mg/kg bw inhalative: comparable to OECD403: LC50 rat (4h) > 52 mg/L ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/685e7f37-2224-44bf-80dc-e9fbb60b4c13/documents/IUC5-b35e568f-a371-45b7-9f28-c062b69142d6_287edebb-80e3-4a2d-9cd8-9dfcb12e0853.html,,,,,, "Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts",68439-57-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/685e7f37-2224-44bf-80dc-e9fbb60b4c13/documents/IUC5-b35e568f-a371-45b7-9f28-c062b69142d6_287edebb-80e3-4a2d-9cd8-9dfcb12e0853.html,,oral,LD50,"2,079 mg/kg bw",adverse effect observed, "Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts",68439-57-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/685e7f37-2224-44bf-80dc-e9fbb60b4c13/documents/IUC5-b35e568f-a371-45b7-9f28-c062b69142d6_287edebb-80e3-4a2d-9cd8-9dfcb12e0853.html,,dermal,LD50,"6,300 mg/kg bw",no adverse effect observed, "Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts",68439-57-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/685e7f37-2224-44bf-80dc-e9fbb60b4c13/documents/IUC5-b35e568f-a371-45b7-9f28-c062b69142d6_287edebb-80e3-4a2d-9cd8-9dfcb12e0853.html,,inhalation,discriminating conc.,0.052 mg/m3,no adverse effect observed, "Sulfonic acids, C14-17-sec-alkane, sodium salts",97489-15-1,"Sec-alkane sulfonate-sodium salts SAS as 60% aqueous solution was tested for systemic toxicity using both, the oral and dermal route of exposure. All available tests are no guideline studies and non-GLP but performed according to scientific standards at time of performance and of acceptable validity based on nowadays standards. Reliability declarations regarding procedures and performance are available. The studies are well performed and documented. Based on the results of a chronic oral toxicity study with 60% aqueous solution of sec-alkane sulfonate-sodium salts SAS in rats, a NOEL of 200 mg/kg body weight per day is used for risk assessment purposes, although no significant changes have been reported even at dietary levels of up to 2% (w/w) corresponding to about 1000 mg/kg body weight per day which is regarded to be a NOAEL..A subacute dermal toxicity study in mice, performed with a 60% aqueous solution of sec-alkane sulfonate-sodium salts SAS revealed no indications of toxicity after dermal treatment at 8% (w/v) for 4 or 5 consecutive weeks. Based on the results of this test, the NOEL for local effects was calculated with approximately 500 mg / kg body per day. At higher test concentrations signs of irritation / inflammation at the treated skin sites were revealed. Systemic toxic effects were not observed. Inhalation studies with repeated exposure are not available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/442718cc-2d2e-412a-92cf-afb3183f5e1e/documents/IUC5-7db183c2-8224-4b06-8f12-69f80c0bde25_8b39de0c-77cb-46d4-b6c8-57c38ed8b9b7.html,,,,,, "Sulfonic acids, C14-17-sec-alkane, sodium salts",97489-15-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/442718cc-2d2e-412a-92cf-afb3183f5e1e/documents/IUC5-7db183c2-8224-4b06-8f12-69f80c0bde25_8b39de0c-77cb-46d4-b6c8-57c38ed8b9b7.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,mouse "Sulfonic acids, C14-17-sec-alkane, sodium salts",97489-15-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/442718cc-2d2e-412a-92cf-afb3183f5e1e/documents/IUC5-7db183c2-8224-4b06-8f12-69f80c0bde25_8b39de0c-77cb-46d4-b6c8-57c38ed8b9b7.html,Chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Sulfonic acids, C14-17-sec-alkane, sodium salts",97489-15-1,"The acute oral toxicity of sec-alkane sulfonate-sodium salts SAS (93%) was investigated in male and female rats using OECD test guideline 401. The study followed the principles of GLP and is regarded to be valid without restrictions. After administration of 2000 mg/kg body weight all animals died whereas after application of 500 mg/kg body weight no mortalities occurred. The LD50 after oral application is between 500 and 2000 mg/kg body weight. Regarding dermal exposure, all available data do not indicate any acute and/or systemic toxic potential of sec-alkane sulfonate-sodium sal SAS (93%). No data are available to evaluate the acute inhalation toxicity of sec-alkane sulfonate-sodium salts SAS (93%) but due to the physical chemical characteristics inhalation is no exposure route of concern. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/442718cc-2d2e-412a-92cf-afb3183f5e1e/documents/IUC5-a38ed067-de86-4b24-8010-a377ed386e68_8b39de0c-77cb-46d4-b6c8-57c38ed8b9b7.html,,,,,, "Sulfonic acids, C16-alkane hydroxy and C16-alkene, sodium salts",93686-15-8,"No experimental data are available for the target substance C16 IOS-Na.   An acute oral toxicity study according to OECD Test Guideline (TG) 401 is available for the closely related source substance 2 (C14-16 AOS-Na). In this study male and female animals (5 per group; 2000 mg/kg bw only 5 females) have been given a single oral dose of the test substance in water. The dose groups were 0 (control), 1600, 2500 or 4000 mg/kg bw. Mortality was seen in male animals starting from the lowest dose group and for females at and about 2000 mg/kg. Clinical signs of intoxication were non-specific e.g. lethargy, decreased motor activity and respiratory rate, diarrhea and, at necropsy, major findings were irritation of the gastrointestinal tract. The oral LD50 of source substance 2 (C14-16 AOS-Na) in rat was >2000 mg/kg bw and thus the test substance does not have to be classified for acute oral toxicity.   The result can be also applied for the target substance because the minor structural differences between the target substance and source substance 2 (see details above) are not expected to have an impact on acute oral toxicity.    In an available review (Ter Haar, 1983a) the testing of 6 different samples of 36.9% Sulfonic acids, C14-16 (even numbered)-alkane hydroxy and C14-16 (even numbered)-alkene, sodium salts in male rats is described, and although documentation is limited, acceptable LD50 values, ranging from 3800 to 4500 mg/kg bw and referring to active ingredient, are reported, which are acceptable for assessment. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): OECD guideline study, no deviations, GLP ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/449e6679-c32e-48a6-8560-795931dfd266/documents/0fde17e7-6366-407f-a97f-9f652364747f_095a1fe7-ea2f-4fc6-86a6-27b129714e39.html,,,,,, "Sulfonic acids, C16-alkane hydroxy and C16-alkene, sodium salts",93686-15-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/449e6679-c32e-48a6-8560-795931dfd266/documents/0fde17e7-6366-407f-a97f-9f652364747f_095a1fe7-ea2f-4fc6-86a6-27b129714e39.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Sulfuric acid, mono-C16-20-alkyl esters, sodium salts",91648-55-4," No data are available for the target substance Sulfuric acid, mono-C16-20 (even numbered)-alkyl esters, sodium salts (CAS 91648-55-4). Therefore, read-across from structural analogue source substance has been applied and a NOAEL of 488 mg/kg bw/day for oral and dermal exposure was established for all alkyl sulfates (AS) read-across source substances. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c44437c9-2ac5-4289-9a43-258d459e8f89/documents/IUC5-d1fab146-2cc6-4285-b496-cb5a9278b2b2_61ba6e0e-441b-4edd-be68-f14ce3413ff2.html,,,,,, "Sulfuric acid, mono-C16-20-alkyl esters, sodium salts",91648-55-4,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c44437c9-2ac5-4289-9a43-258d459e8f89/documents/IUC5-d1fab146-2cc6-4285-b496-cb5a9278b2b2_61ba6e0e-441b-4edd-be68-f14ce3413ff2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,488 mg/kg bw/day,,rat "Sulfuric acid, mono-C16-20-alkyl esters, sodium salts",91648-55-4,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c44437c9-2ac5-4289-9a43-258d459e8f89/documents/IUC5-d1fab146-2cc6-4285-b496-cb5a9278b2b2_61ba6e0e-441b-4edd-be68-f14ce3413ff2.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,,mouse "Sulfuric acid, mono-C16-20-alkyl esters, sodium salts",91648-55-4," No data are available for the target substance Sulfuric acid, mono-C16-20 (even numbered)-alkyl esters, sodium salts (CAS 91648-55-4). Therefore, read-across from structural analogue substances has been applied. Oral LD50 (OECD 401), rat = 4010 mg/kg bw Read-across from structural analogue source substances Sulfuric acid, mono-C12-18-alkyl esters, sodium salts (CAS 68955-19-1) Dermal LD50 (OECD 402), rabbit > 2000 mg/kg bw (limit test) Read-across from structural analogue source substance sodium octyl sulfate (CAS 142-31-4) Acute toxicity by inhalation was not tested according to REGULATION (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c44437c9-2ac5-4289-9a43-258d459e8f89/documents/IUC5-1fd916e6-438f-4b10-aed0-f582e77c2d75_61ba6e0e-441b-4edd-be68-f14ce3413ff2.html,,,,,, "Sulfuric acid, mono-C16-20-alkyl esters, sodium salts",91648-55-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c44437c9-2ac5-4289-9a43-258d459e8f89/documents/IUC5-1fd916e6-438f-4b10-aed0-f582e77c2d75_61ba6e0e-441b-4edd-be68-f14ce3413ff2.html,,oral,LD50,"4,010 mg/kg bw",adverse effect observed, "Sulfuric acid, mono-C16-20-alkyl esters, sodium salts",91648-55-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c44437c9-2ac5-4289-9a43-258d459e8f89/documents/IUC5-1fd916e6-438f-4b10-aed0-f582e77c2d75_61ba6e0e-441b-4edd-be68-f14ce3413ff2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Paraffin oils, sulfochlorinated, saponified",68188-18-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/409add10-71b3-429a-beed-1b80634d0cdb/documents/IUC5-7c4cdcb2-db6e-4570-996e-7e9bafe387cf_930d3d39-67f2-48e0-812d-07dc79a96e41.html,Chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Paraffin oils, sulfochlorinated, saponified",68188-18-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/409add10-71b3-429a-beed-1b80634d0cdb/documents/IUC5-4887dd29-1b5b-4451-b375-3c25009d25ef_930d3d39-67f2-48e0-812d-07dc79a96e41.html,,oral,LD50,"1,271 mg/kg bw",adverse effect observed, "Paraffin oils, sulfochlorinated, saponified",68188-18-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/409add10-71b3-429a-beed-1b80634d0cdb/documents/IUC5-4887dd29-1b5b-4451-b375-3c25009d25ef_930d3d39-67f2-48e0-812d-07dc79a96e41.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl laurate,13557-75-0," In an oral toxicity study on a suitable read-across partners (sodium stearoyl lactylates), no adverse effects were observed up to doses far above the relevant limit dose of 1000 mg/kg bw/day. Therefore, sodium lauroyl lactylate is not considered to be hazardous substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/075b3303-7808-4334-9e30-72b35805be2b/documents/5b7c58c9-705b-4699-9001-cc230b444197_8efb6fa1-1d6a-4e17-9158-aebc80b0bb86.html,,,,,, Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl laurate,13557-75-0," The available studies on test item sodium lauroyl lactylate, its metabolite (lauric acid) as well as its read-across substances (sodium stearoyl lactylate and sodium isostearoyl lactylate) have all shown no acute oral toxicity concern. The oral LD50 values of sodium isostearoyl lactylate (Pationic ISL) and sodium stearoyl lactylate were determined to be greater than 6100 mg/kg bw and 5000 mg/kg, respectively, in male albino rats. Furthermore, supporting information has shown that 10% concentration of sodium lauroyl lactylate and lauric acid have reported acute oral LD50 values of 6810 mg/kg bw and 12000 mg/kg bw, respectively, in rats. Altogether, by way of read-across and taking a weight-of-evidence approach, sodium lauroyl lactylate is not acutely toxic via the oral route. Acute dermal toxicity testing is not necessary as the substance is classified as corrosive to the skin, and acute inhalation toxicity testing is not necessary due to lack of exposure potential (very low vapour pressure, amorphous solid with no potential for dust or aerosol generation). In conclusion, sodium lauroyl lactylate is not known to be acutely toxic via any route of administration. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/075b3303-7808-4334-9e30-72b35805be2b/documents/8efb0dcc-527e-4f21-a235-1242c74bba9a_8efb6fa1-1d6a-4e17-9158-aebc80b0bb86.html,,,,,, Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl laurate,13557-75-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/075b3303-7808-4334-9e30-72b35805be2b/documents/8efb0dcc-527e-4f21-a235-1242c74bba9a_8efb6fa1-1d6a-4e17-9158-aebc80b0bb86.html,,oral,LD50,"6,100 mg/kg bw",no adverse effect observed, Sodium octane-1-sulphonate monohydrate,5324-84-5, Repeat dose toxicity: oral; NOAEL = 5000 ppm (430 mg/kg bw/d); OECD 408; Walker et al. (1967) (Read-across) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6560ba26-da07-4e9b-840b-d043f6f78e1e/documents/17ffc23e-e086-47a7-a0c4-f17eb0e4c6ad_5a60de69-c54c-432c-ae28-ddcdf9ca6b20.html,,,,,, Sodium octane-1-sulphonate monohydrate,5324-84-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6560ba26-da07-4e9b-840b-d043f6f78e1e/documents/17ffc23e-e086-47a7-a0c4-f17eb0e4c6ad_5a60de69-c54c-432c-ae28-ddcdf9ca6b20.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,430 mg/kg bw/day,,rat Sodium octane-1-sulphonate monohydrate,5324-84-5," Acute toxicity oral: Study not required because test item is corrosive (Cat. 1B); Regulation (EC) 1907/2006, Annex VII, Part 8.5, Column 2. Acute toxicity inhalation: Study not required because test item is corrosive (Cat. 1B); test item not available in granular form, Regulation (EC) 1907/2006, Annex VIII, Part 8.5, Part 8.5.2., Column 2. Acute toxicity dermal: Study not required because test item is corrosive (Cat. 1B); Regulation (EC) 1907/2006, Annex VIII, Part 8.5, Column 2. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6560ba26-da07-4e9b-840b-d043f6f78e1e/documents/2e9c55fa-e46d-407d-9104-00da4fe8c99d_5a60de69-c54c-432c-ae28-ddcdf9ca6b20.html,,,,,, Sodium carbonate,497-19-8," No reliable repeated dose studies are available. It is however clear that exposure to sodium carbonate will not result in increased systemic levels of sodium and carbonate due to the homeostatic regulation of both ions. Hence, no further studies are considered necessary for this endpoint. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ac99b6b-7ea5-40f9-8ee0-df7b0e7d0707/documents/IUC5-89c5563f-b0ef-4478-8220-b7839072dadc_d4264203-422f-4c5e-8410-559462f908b0.html,,,,,, Sodium carbonate,497-19-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ac99b6b-7ea5-40f9-8ee0-df7b0e7d0707/documents/IUC5-60642de7-331a-45c4-b0bd-53b7aa0a6621_d4264203-422f-4c5e-8410-559462f908b0.html,,oral,LD50,"2,800 mg/kg bw",, Sodium carbonate,497-19-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ac99b6b-7ea5-40f9-8ee0-df7b0e7d0707/documents/IUC5-60642de7-331a-45c4-b0bd-53b7aa0a6621_d4264203-422f-4c5e-8410-559462f908b0.html,,dermal,LD50,"2,000 mg/kg bw",, "Disodium carbonate, compound with hydrogen peroxide (2:3)",15630-89-4,"Sodium percarbonate rapidly dissociates into the source substance hydrogen peroxide and sodium carbonate. Data on (eco)toxicity of hydrogen peroxide can therefore be used to determine the (eco)toxicity of sodium percarbonate. Although sodium carbonate is also formed, this substance is not considered (eco)toxicologically relevant compared to the effects of hydrogen peroxide.   A 90-day oral, subchronic toxicity study with a 35 % aqueous solution of hydrogen peroxide dissolved in drinking water to produce concentrations ranging from 100 to 3000 ppm was performed with C57BL/6NCrlBR mice under GLP conditions and in essential accordance with OECD Guideline No. 408. C57BL/6NCRlBR mice were chosen due to their particular sensitivity to hydrogen peroxide because of a deficient detoxification pathway. The strain can therefore be regarded as a very sensitive animal model for this particular substance. Based on dose-related reductions in food and water consumption and the observation of duodenal mucosal hyperplasia the lowest observed effect level in the study was 300 ppm and the no observed effect level (NOEL) was 100 ppm (26 and 37 mg/kg/day for males and females, respectively). Clinical pathologic effects (decreased total protein and globulin blood levels) were limited to the 3000 ppm level. All effects noted during the treatment period were reversible; animals sacrificed following the recovery period were considered biologically normal. This can be re-calculated to 348 ppm were no treatment related effects were observed and a LOEL of 1045 ppm for sodium percarbonate.   A repeated dose inhalation toxicity study was performed with male and female Alpk:APfSD (Wistar-derived) rats exposed to hydrogen peroxide vapours for 6 hours per day, 5 days per week for a period of 28 days at concentrations of 2.03, 10.3 or 23.3 ppm. The study was carried out under GLP conditions and in accordance with OECD Guideline No. 412. Treatment of a group exposed initially to 58.1 ppm and subsequently to 27.3 ppm was terminated before schedule due to the toxicity of the test material. The no observed effect level (NOEL) for the study was considered to be 2.03 ppm hydrogen peroxide (corresponding to 2.9 mg/m3). This can be re-calculated to a NOEL of 7 ppm for sodium percarbonate (corresponding to 10.1 mg/m3).   A sub-chronic (13-week) inhalation toxicity study with Hydrogen Peroxide was performed in Wistar rats according to OECD 413. Based on the absence of adverse effects in this study, it can be concluded that the No-Observed-Adverse-Effect-Level (NOAEL) of hydrogen peroxide upon subchronic exposure for male and female animals is at the high concentration level, i.e. 7.08 ppm, corresponding to 9.9 mg/m3. This can be re-calculated to a NOAEL of 35.61 mg/m3 for sodium percarbonate. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1eef925-537d-48c0-89db-b19c484c5cd3/documents/IUC5-f994ba8b-acc8-4f4b-bd8e-a54ea16b4274_fc122f93-febd-4018-94b8-f3c69041002a.html,,,,,, "Disodium carbonate, compound with hydrogen peroxide (2:3)",15630-89-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1eef925-537d-48c0-89db-b19c484c5cd3/documents/IUC5-f994ba8b-acc8-4f4b-bd8e-a54ea16b4274_fc122f93-febd-4018-94b8-f3c69041002a.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,10.1 mg/m3,,rat "Disodium carbonate, compound with hydrogen peroxide (2:3)",15630-89-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1eef925-537d-48c0-89db-b19c484c5cd3/documents/IUC5-f994ba8b-acc8-4f4b-bd8e-a54ea16b4274_fc122f93-febd-4018-94b8-f3c69041002a.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,35.61 mg/m3,,rat "Disodium carbonate, compound with hydrogen peroxide (2:3)",15630-89-4,"A reliable and valid acute toxicity study is available for the oral route (Glaza 1990a) resulting in an LD50 value for male and female Alderley Park albino rats of 1034 mg/kg body weight. The reliable and valid acute dermal toxicity study performed with rabbits resulted in a LD50 value of greater 2000 mg/kg body weight and did not produce mortality nor clinical signs related to the test material in the test animals. No valid study on acute inhalation toxicity of sodium percarbonate is available. As sodium percarbonate will rapidly dissociate into hydrogen peroxide in the respiratory tract, information on the acute inhalation toxicity can be considered. The LC50 value of hydrogen peroxide (49.3 % aqueous solution) was > 170 mg/m3 (Hoffman, 1990) and the LC50 value of sodium carbonate was 1200 mg/m3 in the mouse and 2300 mg/m3 in the rat (Busch et al, 1983). The existing animal data on acute toxicity show that sodium percarbonate has a local effect and that systemic effects are not to be expected.   Busch RH, McDonald KE, Briant JK, Morris JE, Graham TM (1983). Pathologic effects in rodents expos ed to sodium combustion products. Environmental Research, 31, 138-147. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1eef925-537d-48c0-89db-b19c484c5cd3/documents/IUC5-f3a643fc-3dfd-416d-b95f-b95e6abc242f_fc122f93-febd-4018-94b8-f3c69041002a.html,,,,,, "Disodium carbonate, compound with hydrogen peroxide (2:3)",15630-89-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1eef925-537d-48c0-89db-b19c484c5cd3/documents/IUC5-f3a643fc-3dfd-416d-b95f-b95e6abc242f_fc122f93-febd-4018-94b8-f3c69041002a.html,,oral,LD50,"1,034 mg/kg bw",adverse effect observed, "Disodium carbonate, compound with hydrogen peroxide (2:3)",15630-89-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1eef925-537d-48c0-89db-b19c484c5cd3/documents/IUC5-f3a643fc-3dfd-416d-b95f-b95e6abc242f_fc122f93-febd-4018-94b8-f3c69041002a.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Disodium carbonate, compound with hydrogen peroxide (2:3)",15630-89-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1eef925-537d-48c0-89db-b19c484c5cd3/documents/IUC5-f3a643fc-3dfd-416d-b95f-b95e6abc242f_fc122f93-febd-4018-94b8-f3c69041002a.html,,inhalation,LC50,> 590 mg/m3,no adverse effect observed, Sodium chlorate,7775-09-9," In the sub-chronic studies performed in rats, the main target organ was the blood (with anaemia effects). The NOAEL obtained in the two studies is very similar. The GLP study reported in 1987 is more reliable as all the parameters required in Directive 2001/59/EC, Annex V, Method B.26 were evaluated and reported while in the non GLP study published in 1995 all these parameters were not reported (or incompletely reported). The thyroid effects described by McCauley et al.(1995) at levels above 100 mg/kg bw are of uncertain clinical significance and were not observed in the rat and dog GLP studies. An increased level of thyroid colloid depletion compared to control can be regarded the result of a physiological adaptation and not an adverse effect per se. In the 90-day study performed in the dog, there were no significant toxic effects up to the highest dose level tested. Considering that dogs have lower levels of methaemoglobin reductase than humans and thus are more susceptible to methaemoglobin, the higher NOAEL level in this studies for dogs adds to the confidence of the reliability of the 100 mg/kg NOAEL obtained in rats. The overall lowest sub-chronic NOAEL is 100 mg/kg bw/day, based on effects on erythrocytes; and a No Observed Effect Level (NOEL) of 38 mg/kg in males and 55 mg/kg in females when considering the physiological colloid depletion observed at the dose of 128 mg/kg in males and 209 mg/kg in females in the McCauley study. Effects on haematology and the thyroid were also observed in a three week study in rats (NOAEL 35 mg/kg bw males and 40 mg/kg bw females) and no effects were seen in mice (NOAEL 350 mg/kg  bw males and 365 mg/kg bw females) (NTP 2005). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70db0099-0c2c-4d2e-8844-da1b1110ff77/documents/IUC5-ba33dc3b-8545-4e42-971b-1172393b6bfb_64ea2e63-ef1b-4770-a617-dd6e34d1ebae.html,,,,,, Sodium chlorate,7775-09-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70db0099-0c2c-4d2e-8844-da1b1110ff77/documents/IUC5-ba33dc3b-8545-4e42-971b-1172393b6bfb_64ea2e63-ef1b-4770-a617-dd6e34d1ebae.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Sodium chlorate,7775-09-9,"Animal studies with sodium chlorate show a low acute toxicity after inhalation (LC50(4.5h) > 5.59 mg/l), dermal (LD50(24h)  > 2000 mg/kg bw) and oral (LD50 = 4950-6250 mg/kg bw) exposure. Numerous human case studies are reported. Due to vomiting occurring, sometimes rapidly after ingestion, the absorbed quantity is often uncertain. Therefore, variability occurs in the doses causing lethality. Since the 1960s, survival to higher dose levels of chlorate, up to 200 grams (± 3.33 g/kg bw), has increased due to the possibility of dialysis treatment in case of renal failure.   Acute toxicity of chlorate is mediated by methaemoglobin. There are marked species differences in susceptibility to form methaemoglobin. Humans are more affected than rodent species. Infants, particularly neonates, are more prone to methaemoglobinemia than older children and adults and are consequently likely to be more susceptible to the toxicity of chlorate. Related to the rapid urinary excretion, the highest levels of chlorates are reached in the kidneys. Nephrotoxicity also seems mediated by methaemoglobin catalysis.   An evaluation by the French poison control center of sensitivity of humans to sodium chlorate compared to rats led to the following conclusion: If one considers that 50% methemoglobinemia starts to induce signs that may lead to death in the absence of treatment, the dose would be about 20 g / kg for the whole population and 4.5 g / kg for the most sensitive part is the same range as rats.   Despite the low acute toxicity in animals, sodium chlorate has an harmonised classification (index No. 017-005-00-9, ATP0) as Acute Tox. 4 *, H302 (* minimum classification for the category) based on human experience indicating that classification of sodium chlorate is justified. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70db0099-0c2c-4d2e-8844-da1b1110ff77/documents/IUC5-19f1f092-6bed-499b-b8ea-2d3b9153780e_64ea2e63-ef1b-4770-a617-dd6e34d1ebae.html,,,,,, Sodium chlorate,7775-09-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70db0099-0c2c-4d2e-8844-da1b1110ff77/documents/IUC5-19f1f092-6bed-499b-b8ea-2d3b9153780e_64ea2e63-ef1b-4770-a617-dd6e34d1ebae.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium chlorate,7775-09-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70db0099-0c2c-4d2e-8844-da1b1110ff77/documents/IUC5-19f1f092-6bed-499b-b8ea-2d3b9153780e_64ea2e63-ef1b-4770-a617-dd6e34d1ebae.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium chlorate,7775-09-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70db0099-0c2c-4d2e-8844-da1b1110ff77/documents/IUC5-19f1f092-6bed-499b-b8ea-2d3b9153780e_64ea2e63-ef1b-4770-a617-dd6e34d1ebae.html,,inhalation,LC50,"5,590 mg/m3",no adverse effect observed, Sodium chlorite,7758-19-2,"Key study: This study was designed to investigate the toxicity of the test article (sodium chlorite) when administered by gavage daily for 13 weeks to the rat (following EPA guideline ref. 82 -1, GLP study). At the lowest dose level there were no changes considered to be treatment-related and it was therefore, concluded that the no observed effect level was 10 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/908ceaaa-1bb2-48c5-8fe4-e1a206823644/documents/c907efeb-70d4-4b0a-b240-1a18691af89f_89d51d65-380f-4e36-b660-b057c66b7f6b.html,,,,,, Sodium chlorite,7758-19-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/908ceaaa-1bb2-48c5-8fe4-e1a206823644/documents/c907efeb-70d4-4b0a-b240-1a18691af89f_89d51d65-380f-4e36-b660-b057c66b7f6b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Sodium chlorite,7758-19-2,Three Key studies and one supporting study for oral acute toxicity: -Key study. OECD guideline. With rats. LD50= 284 mg/kg bw (pure active) -Key study. EPA guideline. With rats. LD50= 390 mg/kg bw (31% aqueous solution) -Supporting study. No data on test guideline. With rats. LD50 (male)=158 mg/kg bw. LD50 (female)= 177 mg/kg bw -Key study. OECD guideline. With rats. 300 > LD50 < 2000 mg/kg bw (9% aqueous solution) Two Key studies for dermal acute toxicity: -Key study. EPA guideline. With rabbits. LD50= 134 mg//kg bw (male/female) (pure active) -Key study. EPA guideline. With rabbits. Dermal LD50 >2000 mg//kg bw (31% aqueous solution)   ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/908ceaaa-1bb2-48c5-8fe4-e1a206823644/documents/3dfcecb0-b1e0-4117-88bf-4d285ff7fa00_89d51d65-380f-4e36-b660-b057c66b7f6b.html,,,,,, Sodium chlorite,7758-19-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/908ceaaa-1bb2-48c5-8fe4-e1a206823644/documents/3dfcecb0-b1e0-4117-88bf-4d285ff7fa00_89d51d65-380f-4e36-b660-b057c66b7f6b.html,,oral,LD50,284 mg/kg bw,adverse effect observed, Sodium chlorite,7758-19-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/908ceaaa-1bb2-48c5-8fe4-e1a206823644/documents/3dfcecb0-b1e0-4117-88bf-4d285ff7fa00_89d51d65-380f-4e36-b660-b057c66b7f6b.html,,dermal,LD50,134 mg/kg bw,adverse effect observed, Trisodium citrate,68-04-2,"A fairly limited reliable report of a non-standard oral feeding study using tri sodium citrate in the rat, conducted without GLP compliance, identified 10-day NOAEL and LOAEL values in the rat of 8 and 16 g/kg bw/day, respectively. (Bächtold 1978; rel 2) In addition a fairly limited reliable report of a non-standard study using tri sodium citrate conducted without GLP compliance, identified 10-day NOAEL and LOAEL values in the mouse of 4 and 8 g/kg bw/day, respectively. (Bächtold 1978; rel 2). Data from a 150 day oral feeding study where rats were given up to 7.7% as sodium citrate in their diet reported no abnormalities. (Packman et al 1963; rel 4) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60ba87fe-4a67-439d-a313-2238f4625b3d/documents/IUC5-0590ae31-c5cc-4f34-bccd-7c5b3cac2c04_d648e58d-f500-4f50-a080-6e71babbf994.html,,,,,, Trisodium citrate,68-04-2,"The key study for acute oral toxicity was read across from citric acid, which reports an LD50 value of 5400mg/kg (Roche, 1981; rel 2). The acute dermal LD50 value was read across from citric acid and reported to be >2000 mg/kg in rat (Safepharm 2006; rel 1). Data for the acute toxicity inhalation endpoint was waived, since reliable data was available for the acute oral and dermal endpoints. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60ba87fe-4a67-439d-a313-2238f4625b3d/documents/IUC5-ecb000fc-709e-4756-96c8-380b17a648a2_d648e58d-f500-4f50-a080-6e71babbf994.html,,,,,, Trisodium citrate,68-04-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60ba87fe-4a67-439d-a313-2238f4625b3d/documents/IUC5-ecb000fc-709e-4756-96c8-380b17a648a2_d648e58d-f500-4f50-a080-6e71babbf994.html,,oral,LD50,"5,400 mg/kg bw",, Trisodium citrate,68-04-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60ba87fe-4a67-439d-a313-2238f4625b3d/documents/IUC5-ecb000fc-709e-4756-96c8-380b17a648a2_d648e58d-f500-4f50-a080-6e71babbf994.html,,dermal,LD50,"2,680 mg/kg bw",, "Alcohols, C12-14, ethoxylated, sulfates, sodium salts",68891-38-3,"Oral (subchronic, rat, m/f, OECD 408): NOAEL (systemic toxicity) ≥ 225 mg/kg bw/day Oral (subchronic, rat, m/f, OECD 408): LOAEL (local toxicity) = 25 mg/kg bw/day   Conclusion based on data obtained with alcohols, C12-14, ethoxylated, sulfates, sodium salts (CAS No. 68891-38-3, EC No. 500-234-8) and considering all available data on repeated dose toxicity in the Alkyl Ether Sulfates (AES) category in a weight of evidence approach. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5496f5e-90cc-4764-af4e-63623054fe8e/documents/fd7393f5-d988-4b05-8ed2-59838c23ef85_5d6705c2-a398-4821-8760-aeab9c951c3d.html,,,,,, "Alcohols, C12-14, ethoxylated, sulfates, sodium salts",68891-38-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5496f5e-90cc-4764-af4e-63623054fe8e/documents/fd7393f5-d988-4b05-8ed2-59838c23ef85_5d6705c2-a398-4821-8760-aeab9c951c3d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,>= 225 mg/kg bw/day,,rat "Alcohols, C12-14, ethoxylated, sulfates, sodium salts",68891-38-3,"Oral LD50 > 2000 mg/kg bw Conclusion based on data with alcohols, C12-14, ethoxylated, sulfates, sodium salts (CAS No. 68891-38-3, EC No. 500-234-8) and considering all available data on acute oral toxicity in the Alkyl Ether Sulfate (AES) category in a weight of evidence approach.   Inhalation No information required according to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, as data on acute oral and acute dermal toxicity are provided.   Dermal LD50 > 2000 mg/kg bw Conclusion based on data with alcohols, C12-14, ethoxylated, sulfates, sodium salts (CAS No. 68891-38-3, EC No. 500-234-8) and considering all available data on acute dermal toxicity in the AES category in a weight of evidence approach. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5496f5e-90cc-4764-af4e-63623054fe8e/documents/cba07c49-244b-4eda-9f08-714c55f7e50e_5d6705c2-a398-4821-8760-aeab9c951c3d.html,,,,,, "Alcohols, C12-14, ethoxylated, sulfates, sodium salts",68891-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5496f5e-90cc-4764-af4e-63623054fe8e/documents/cba07c49-244b-4eda-9f08-714c55f7e50e_5d6705c2-a398-4821-8760-aeab9c951c3d.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alcohols, C12-14, ethoxylated, sulfates, sodium salts",68891-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5496f5e-90cc-4764-af4e-63623054fe8e/documents/cba07c49-244b-4eda-9f08-714c55f7e50e_5d6705c2-a398-4821-8760-aeab9c951c3d.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "L-Alanine, N-coco acyl derivs., sodium salts",90170-45-9," Oral administration of the registered substance to Wistar rats at doses of 62.5, 250 and 1000 mg/kg/day, for 28 days resulted in two deaths due to aspiration of dosing formulations reflux, no clinical signs during daily or weekly observations, no findings during the functional observational battery or related tests (grip strength and locomotor activity), minor test item-unrelated differences in the mean daily food consumption of females (males were unaffected), no test item-related differences in mean body weights or their development, no test item-related changes in the hematology, clinical biochemistry or urinalysis parameters of males or females at any dose level, no differences of toxicological relevance in the mean absolute and relative organ weights. There were no late test item-related macroscopical changes in males or females after 4 weeks of treatment and 2 weeks of recovery. Test item-related findings were generally restricted to microscopic changes in the forestomach of animals at 1000 mg/kg/day. These lesions consisted of acanthosis, parakeratosis, inflammation, ulceration and erosions. These changes are considered to be `site of first contact` and thus local effects due to irritation rather than systemic toxic effects and are not considered relevant for human health hazard / risk assessment. After the 14 days recovery period, these changes were completely reversible. Comparable forestomach effects were not seen in the rats from the low- and mid-dose groups. Since the forestomach effects are considered to be `site of first contact` and thus local effects which are not relevant for human hazard / risk assessment, the NOAEL of the registered substance with regard to systemic toxicity was established at 1000 mg/kg body weight per day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a47703a8-8549-4394-98ab-e648f4f279dd/documents/caecbd82-e0da-4e93-aee2-b7aa27bbd617_d632fa88-b6f3-44a0-96f3-381b4a791b80.html,,,,,, "L-Alanine, N-coco acyl derivs., sodium salts",90170-45-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a47703a8-8549-4394-98ab-e648f4f279dd/documents/caecbd82-e0da-4e93-aee2-b7aa27bbd617_d632fa88-b6f3-44a0-96f3-381b4a791b80.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "L-Glutamic acid, N-coco acyl derivs., monosodium salts",68187-32-6, no toxicity effect observed ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7aa565d-e187-42ef-ab98-499e0918a4f5/documents/9235e887-f679-45b8-b710-43ee497fe006_2ec0fe58-66ca-4513-ac4b-049d93d6fc5d.html,,,,,, "L-Glutamic acid, N-coco acyl derivs., monosodium salts",68187-32-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7aa565d-e187-42ef-ab98-499e0918a4f5/documents/9235e887-f679-45b8-b710-43ee497fe006_2ec0fe58-66ca-4513-ac4b-049d93d6fc5d.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,425 mg/kg bw/day,,rat "L-Glutamic acid, N-coco acyl derivs., monosodium salts",68187-32-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7aa565d-e187-42ef-ab98-499e0918a4f5/documents/9235e887-f679-45b8-b710-43ee497fe006_2ec0fe58-66ca-4513-ac4b-049d93d6fc5d.html,Short-term repeated dose toxicity – systemic effects,inhalation,,23.96 mg/m3,,rat "L-Glutamic acid, N-coco acyl derivs., monosodium salts",68187-32-6,toxicity not observed in any of the route of exposure. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7aa565d-e187-42ef-ab98-499e0918a4f5/documents/d5455d81-5ee2-441f-8dbb-779d6f6b2c58_2ec0fe58-66ca-4513-ac4b-049d93d6fc5d.html,,,,,, "L-Glutamic acid, N-coco acyl derivs., monosodium salts",68187-32-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7aa565d-e187-42ef-ab98-499e0918a4f5/documents/d5455d81-5ee2-441f-8dbb-779d6f6b2c58_2ec0fe58-66ca-4513-ac4b-049d93d6fc5d.html,,oral,LD50,"4,874 mg/kg bw",no adverse effect observed, "L-Glutamic acid, N-coco acyl derivs., monosodium salts",68187-32-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7aa565d-e187-42ef-ab98-499e0918a4f5/documents/d5455d81-5ee2-441f-8dbb-779d6f6b2c58_2ec0fe58-66ca-4513-ac4b-049d93d6fc5d.html,,dermal,LD50,"4,026.28 mg/kg bw",no adverse effect observed, "Glycine, N-coco acyl derivs., sodium salts",90387-74-9," The test item “Hostapon SG” was tested in a 28 day oral study with rats according to OECD Guideline 407 incl. GLP. The daily dosing with 62.5, 250 and 1000 mg/kg resulted in two deaths due to aspiration of dosing formulations reflux, no clinical signs during daily or weekly observations, no findings during the functional observational battery or related tests (grip strength and locomotor activity), minor test item-unrelated differences in the mean daily food consumption of females (males were unaffected), no test item-related differences in mean body weights or their development, no test item-related changes in the hematology, clinical biochemistry or urinalysis parameters of males or females at any dose level, no differences of toxicological relevance in the mean absolute and relative organ weights. There were no late test item-related macroscopical changes in males or females after 4 weeks of treatment and 2 weeks of recovery. Test item-related findings were generally restricted to microscopic changes in the forestomach of animals at 1000 mg/kg/day. These lesions consisted of acanthosis, parakeratosis, inflammation, ulceration and erosions. These changes are considered to be `site of first contact` and thus local effects due to irritation rather than systemic toxic effects and are not considered relevant for human health hazard / risk assessment. After the 14 days recovery period, these changes were completely reversible. Comparable forestomach effects were not seen in the rats from the low- and mid-dose groups. Since the forestomach effects are considered to be `site of first contact` and thus local effects which are not relevant for human hazard / risk assessment, the NOAEL of the registered substance with regard to systemic toxicity was established at 1000 mg/kg body weight per day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dafaab97-782b-463b-8eef-5ac61a9abf70/documents/c1a03926-47a3-4081-89c6-61dd783429c0_a499cb9a-dd85-4a48-965e-3c09bbc7c2b0.html,,,,,, "Glycine, N-coco acyl derivs., sodium salts",90387-74-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dafaab97-782b-463b-8eef-5ac61a9abf70/documents/c1a03926-47a3-4081-89c6-61dd783429c0_a499cb9a-dd85-4a48-965e-3c09bbc7c2b0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Glycine, N-coco acyl derivs., sodium salts",90387-74-9," The acute oral toxicity of the test item was examined in ICR mice in a study according to OECD Guideline 425. In this study no male or female mouse died following single oral administration of the test item at dose levels of 1000 or 2000 mg/kg bw. Loss of vigor was observed in one case in the male 2.0 g/kg group, wet hair around the anus was observed in one case in each of the male 1.0 g/kg, male 2.0 g/kg and female 2.0 g/kg groups during the observation period for acute toxicity symptoms. No abnormality was observed six hours following administration and onwards. Therefore it is considered that these symptoms are temporary and mild. Body weight increase was inhibited one day following administration in the male 1.0 g/kg group. This was not observed in the male 2.0 g/kg group. In autopsies, a cyst in the left kidney in one case and edema in the uterus in one case were observed in the female 1.0 g/kg group. Edema in the left ovary was observed in one case in the female 2.0 g/kg group. However, these conditions develop spontaneously in this type of mouse, and it is considered irrelevant to the administration of the test article. Therefore, from this study an oral LD50 value of > 2000 mg/kg bw can be derived. The acute dermal toxicity of the test item “Hostapon SG dried” was investigated in an OECD 402 study in accordance with the principles of GLP. Five male and five female Wistar rats were treated with the test substance at 2000 mg/kg by dermal application. The test item was formulated in polyethylene glycol 300 as vehicle. The application period was 24 hours. Following a 14 day observation period all animals were necropsied and examined macroscopically. No intercurrent deaths occurred and no clinical signs were recorded throughout the entire observation period. The only substance related effects consisted of very slight to slight dermal irritation reactions in form of erythema and/or oedema in one male and two females during the observation period. No macroscopic findings were observed at necropsy. Based on the study results the median lethal dose (LD50) of the test item after single dermal administration to rats of both sexes was greater than 2000 mg/kg body weight. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dafaab97-782b-463b-8eef-5ac61a9abf70/documents/85a2571b-9925-49c2-ac40-75b1a294f96f_a499cb9a-dd85-4a48-965e-3c09bbc7c2b0.html,,,,,, "Glycine, N-coco acyl derivs., sodium salts",90387-74-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dafaab97-782b-463b-8eef-5ac61a9abf70/documents/85a2571b-9925-49c2-ac40-75b1a294f96f_a499cb9a-dd85-4a48-965e-3c09bbc7c2b0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Glycine, N-coco acyl derivs., sodium salts",90387-74-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dafaab97-782b-463b-8eef-5ac61a9abf70/documents/85a2571b-9925-49c2-ac40-75b1a294f96f_a499cb9a-dd85-4a48-965e-3c09bbc7c2b0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, coco, 2-sulfoethyl esters, sodium salts",61789-32-0,"There is reliable and robust information concerning the evaluation of the repeated dose toxicity from sodium cocoyl isethionate (SCI) available via oral and dermal route, from a 28-day oral (dietary) study and a 28-day dermal toxicity study. Additionally, there is a 90-day oral gavage study on sodium isethionate (SI) the potentially toxic metabolite of SCI, which can be used to support the evaluation of SCI. In the 28d oral study on rats, SCI achieved a NOAEL of 627 mg/kg bw/day (1% SCI in diet); The 90d oral gavage study on rats with SI resulted to a NOAEL of 426 mg/kg bw/d when converted to SCI. The 28-day study with SCI via dermal route resulted to a NOAEL of 2070 mg/kg bw/day, and a NEC (No Effect Concentration) of 36% SCI in aqueous suspension via skin.   In addition to the available data and the read-across to metabolite(s), there is sufficient weight of evidence (WoE) from the use of newly developed methods and technologies not yet included in the test methods referred to in Article 13(3) - i.e., a Next Generation Safety Assessment (“NGSA”) to further support lack of concerns for systemic toxicity by SCI. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5b4ae04-5c8d-409e-8cbc-2bccc1f8b84f/documents/IUC5-6fd1e0e5-6632-4680-9495-a654a21def35_8e4fb372-1ec7-4547-af0c-5d4e0877ca47.html,,,,,, "Fatty acids, coco, 2-sulfoethyl esters, sodium salts",61789-32-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5b4ae04-5c8d-409e-8cbc-2bccc1f8b84f/documents/IUC5-6fd1e0e5-6632-4680-9495-a654a21def35_8e4fb372-1ec7-4547-af0c-5d4e0877ca47.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,627 mg/kg bw/day,,rat "Fatty acids, coco, 2-sulfoethyl esters, sodium salts",61789-32-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5b4ae04-5c8d-409e-8cbc-2bccc1f8b84f/documents/IUC5-6fd1e0e5-6632-4680-9495-a654a21def35_8e4fb372-1ec7-4547-af0c-5d4e0877ca47.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,070 mg/kg bw/day",,rat "Fatty acids, coco, 2-sulfoethyl esters, sodium salts",61789-32-0,"There is a Klimisch validity 1, GLP oral LD50 study available for Coco fatty acids 2-sulfoethyl ester, sodium salt.  This study showed no adverse effects in the 5 males and 5 females dosed at 2000mg/kg.  Based on the oral LD50 being >2000mg/kg.  Dosing by the inhalation and dermal route has been waived as not scientifically justified. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5b4ae04-5c8d-409e-8cbc-2bccc1f8b84f/documents/IUC5-0d5f584d-cdbe-418c-87dc-2e99363daff8_8e4fb372-1ec7-4547-af0c-5d4e0877ca47.html,,,,,, "Glycine, N-methyl-, N-coco acyl derivs., sodium salts",61791-59-1," Repeated dose toxicity - oral (no OECD, 2-year study), rat: NOAEL ≥ 1000 mg/kg bw/day Repeated dose toxicity - oral (OECD 408, 90-day), rat: NOAEL ≥ 250 mg/kg bw/day RA from source substance Sodium N-lauroylsarcosinate (CAS 137-16-6) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f77b7ea9-2bec-4c3d-91dc-e0ef7095ee23/documents/94e2567d-e21a-4410-9e62-6776397d114b_645373e3-59d8-49ad-9fd9-2557240fcfd9.html,,,,,, "Glycine, N-methyl-, N-coco acyl derivs., sodium salts",61791-59-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f77b7ea9-2bec-4c3d-91dc-e0ef7095ee23/documents/94e2567d-e21a-4410-9e62-6776397d114b_645373e3-59d8-49ad-9fd9-2557240fcfd9.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Glycine, N-methyl-, N-coco acyl derivs., sodium salts",61791-59-1," Oral: (WoE, OECD 401), rat: LD50 > 5000 mg/kg bw Data obtained with the registered substance and further supported by Weight-of-Evidence referring to the analogue substances Sodium N-lauroylsarcosinate (CAS 137-16-6) and N-methyl-N-[C18-(unsaturated)alkanoyl]glycine (EC 701-177-3) Inhalation: Data waiving as studies for two other routes, i.e. oral and dermal, are provided. Dermal (WoE, OECD 402), rat: LD50 > 2000 mg/kg bw Weight-of-Evidence approach referring to the analogue substances Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate (CAS 30364-51-3), N-lauroylsarcosine (CAS 97-78-9) and Ammonium N-methyl-N-(1-oxododecyl)glycinate (CAS 68003-46-3) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f77b7ea9-2bec-4c3d-91dc-e0ef7095ee23/documents/2390a0d6-4073-44fc-bc90-c911f58eb3fc_645373e3-59d8-49ad-9fd9-2557240fcfd9.html,,,,,, Sodium cumenesulphonate,28348-53-0," Oral repeated dose toxicity 20 CD rats per sex per dose level were exposed to sodium cumene sulfonate at 0, 0.005, 0.05 and 0.5% in the diet. Mean administered doses were 0, 2.6, 26 and 270 mg/kg bw for males and 0, 3.6, 36 and 375 mg/kg bw for females. Taking into account the content of active ingredient, 42.3%, these doses equate to 1.1, 11 and 114 mg a.i./kg bw and 1.5, 15 ad 159 mg a.i./kg bw, respectively. Endpoints were mortality, body and organ weight, food consumption, haematology, and histopathology. No treatment related effects were observed in males at up to the highest dose (114 mg a.i./kg bw). The only effect observed was an 11.7% decrease in body weight gain in females at the highest dose (159 mg a.i./kg bw). The study report stated that this decrease in body weight gain was within the established ranges for animals of this species and age and was therefore not considered an adverse effect by the authors. The feed efficiency of the high dose females was statistically higher than the controls. The decrease in body weight gain of the high dose females was not associated with any histopathologic or other effects. In light of the palatability issues seen in the previously discussed study, this slight decrease in body weight gain may be explained as a palatability effect Also, the intervals between the dose levels in this study are large (factor of 10), while OECD 408 prefers 2-4 fold intervals and prefers an additional group if the factors are > 6-10. A NOAEL for sodium cumene sulfonate is therefore >114 mg a.i./kg bw for males and >159 mg a.i./kg bw in femalesif the slight decrease in body weight gain is not considered toxicologically significant.   Dermal repeated dose toxicity  The NOAEL was 800 mg/kg bw per day, on the basis of epidermal hyperplasia.   The generic modification from the NOAELtest (in mg/kg of body weight) to NOAELmodified (in mg/cm2/day) will be NOAELin mg/cm2 = ((dose in mg/kg bw)x (average animal weight in kg)) / Treated surface in cm2) NOAELtest* 0.25/44.5= NOAELmodified The highest dose not causing irritation/corrosion was 800 mg/kg bw in dermal toxicity study in rats The modified dose descriptor would be:    NOAELmodified=800 mg/kg*0.25 kg/44.5cm2=4.49mg/cm2      Inhalation repeated dose toxicity  The oral dose for the rat is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m3/kg for 24 hours exposure. The resulting air concentration needs to be additionally corrected for 24 hlight activity (20 m3), assuming 100 % absorption for both routes. NOAEL rat              114 mg/kg bw/day ÷1.15 m3/kgbw ÷20m3/rat NOAECrat    4.96 mg/m3 ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/019b27c7-6b33-404c-9e1d-7f942e21fcaf/documents/256cd7a0-f392-4357-b7a9-6311c880b8fa_278e0719-b88b-4cd9-a6d7-1647ea1b02ab.html,,,,,, Sodium cumenesulphonate,28348-53-0,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/019b27c7-6b33-404c-9e1d-7f942e21fcaf/documents/256cd7a0-f392-4357-b7a9-6311c880b8fa_278e0719-b88b-4cd9-a6d7-1647ea1b02ab.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,114 mg/kg bw/day,,rat Sodium cumenesulphonate,28348-53-0,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/019b27c7-6b33-404c-9e1d-7f942e21fcaf/documents/256cd7a0-f392-4357-b7a9-6311c880b8fa_278e0719-b88b-4cd9-a6d7-1647ea1b02ab.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,800 mg/kg bw/day,,rat Sodium cumenesulphonate,28348-53-0,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/019b27c7-6b33-404c-9e1d-7f942e21fcaf/documents/256cd7a0-f392-4357-b7a9-6311c880b8fa_278e0719-b88b-4cd9-a6d7-1647ea1b02ab.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,4.96 mg/m3,,rat Sodium cumenesulphonate,28348-53-0,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/019b27c7-6b33-404c-9e1d-7f942e21fcaf/documents/256cd7a0-f392-4357-b7a9-6311c880b8fa_278e0719-b88b-4cd9-a6d7-1647ea1b02ab.html,Repeated dose toxicity – local effects,dermal,NOAEL,4.49 mg/cm2,no adverse effect observed,rat Sodium cumenesulphonate,28348-53-0,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/019b27c7-6b33-404c-9e1d-7f942e21fcaf/documents/256cd7a0-f392-4357-b7a9-6311c880b8fa_278e0719-b88b-4cd9-a6d7-1647ea1b02ab.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4.96 mg/m3,no adverse effect observed,rat Sodium cumenesulphonate,28348-53-0," -Acute oral toxicity:. The acute oral LD50 in male/female rats is > 7000 mg/kg bw for Sodium cumenesulphonate No significant gross abnormalities were seen at autopsy.    This show that Sodium cumenesulphonate is practically nontoxic for acute oral toxicity.    -Acute Dermal Toxicity: The acute lethal dermal dose was found to be greater than 2000 mg/kg. This show that Sodium cumenesulphonate is practically nontoxic for acute dermal toxicity.   - Inhalatory toxicity: The inhalatory LC50, 4h value of sodium cumenesulphonate in Albino  Wistar rats was established to exceed 770 mg/L.    This show that Sodium cumenesulphonate is practically nontoxic for acute inhalation toxicity.     It is concluded that the substance sodium cumenesulphonate does not meet the criteria to be classified for human health hazards for acute oral, inhalation and dermal effects. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/019b27c7-6b33-404c-9e1d-7f942e21fcaf/documents/fcd11d5c-e493-4020-9c1a-2547cbee6a8c_278e0719-b88b-4cd9-a6d7-1647ea1b02ab.html,,,,,, Sodium cumenesulphonate,28348-53-0,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/019b27c7-6b33-404c-9e1d-7f942e21fcaf/documents/fcd11d5c-e493-4020-9c1a-2547cbee6a8c_278e0719-b88b-4cd9-a6d7-1647ea1b02ab.html,,oral,LD50,"7,000 mg/kg bw",no adverse effect observed, Sodium cumenesulphonate,28348-53-0,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/019b27c7-6b33-404c-9e1d-7f942e21fcaf/documents/fcd11d5c-e493-4020-9c1a-2547cbee6a8c_278e0719-b88b-4cd9-a6d7-1647ea1b02ab.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium cumenesulphonate,28348-53-0,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/019b27c7-6b33-404c-9e1d-7f942e21fcaf/documents/fcd11d5c-e493-4020-9c1a-2547cbee6a8c_278e0719-b88b-4cd9-a6d7-1647ea1b02ab.html,,inhalation,LC50,"770,000 mg/m3",no adverse effect observed, Sodium cyanate,917-61-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Beside a subacute 28-day repeated dose toxicity study, for sodium cyanate only a number of non standard public available literature studies are available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb9d6081-7257-46ac-bf49-c203dfd5c885/documents/541fd683-7b61-481a-a6b6-95f715dd8e18_cf1ddde3-acaa-4624-b9e7-564db79b3040.html,,,,,, Sodium cyanate,917-61-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb9d6081-7257-46ac-bf49-c203dfd5c885/documents/541fd683-7b61-481a-a6b6-95f715dd8e18_cf1ddde3-acaa-4624-b9e7-564db79b3040.html,Chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,dog Sodium cyanate,917-61-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Four different non GLP studies available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): One GLP and guideline compliant study available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb9d6081-7257-46ac-bf49-c203dfd5c885/documents/2c3e47df-469e-4b77-93c1-48141437f575_cf1ddde3-acaa-4624-b9e7-564db79b3040.html,,,,,, Sodium cyanate,917-61-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb9d6081-7257-46ac-bf49-c203dfd5c885/documents/2c3e47df-469e-4b77-93c1-48141437f575_cf1ddde3-acaa-4624-b9e7-564db79b3040.html,,oral,LD50,582 mg/kg bw,adverse effect observed, Sodium cyanate,917-61-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb9d6081-7257-46ac-bf49-c203dfd5c885/documents/2c3e47df-469e-4b77-93c1-48141437f575_cf1ddde3-acaa-4624-b9e7-564db79b3040.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Sodium decyl sulphate,142-87-0,For the whole category of alkyl sulfates (AS) a NOAEL of 488 mg/kg bw/day for oral and dermal exposure was established. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2eb7c4ae-c531-436d-afd2-494ea0f55b77/documents/IUC5-271384d7-ec66-4e30-9fc5-6d6ede8ab42b_3cd3f9c5-f06d-4951-89b6-e78468c9f13a.html,,,,,, Sodium decyl sulphate,142-87-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2eb7c4ae-c531-436d-afd2-494ea0f55b77/documents/IUC5-271384d7-ec66-4e30-9fc5-6d6ede8ab42b_3cd3f9c5-f06d-4951-89b6-e78468c9f13a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,488 mg/kg bw/day,,rat Sodium decyl sulphate,142-87-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2eb7c4ae-c531-436d-afd2-494ea0f55b77/documents/IUC5-271384d7-ec66-4e30-9fc5-6d6ede8ab42b_3cd3f9c5-f06d-4951-89b6-e78468c9f13a.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,,mouse Sodium decyl sulphate,142-87-0,"Oral LD50 (OECD guideline 401), rat = 1200 mg/kg bwDermal LD50 (OECD guideline 402), rabbit >= 2000 mg/kg bw (limit test) Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2eb7c4ae-c531-436d-afd2-494ea0f55b77/documents/IUC5-b305b21f-1382-4121-91a4-2ab4d4fa5f1b_3cd3f9c5-f06d-4951-89b6-e78468c9f13a.html,,,,,, Sodium decyl sulphate,142-87-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2eb7c4ae-c531-436d-afd2-494ea0f55b77/documents/IUC5-b305b21f-1382-4121-91a4-2ab4d4fa5f1b_3cd3f9c5-f06d-4951-89b6-e78468c9f13a.html,,oral,LD50,"1,200 mg/kg bw",adverse effect observed, Sodium decyl sulphate,142-87-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2eb7c4ae-c531-436d-afd2-494ea0f55b77/documents/IUC5-b305b21f-1382-4121-91a4-2ab4d4fa5f1b_3cd3f9c5-f06d-4951-89b6-e78468c9f13a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sodium 1-(3,4-dihydro-6-methyl-2,4-dioxo-2H-pyran-3-ylidene)ethanolate",4418-26-2," Repeat oral toxicity: In a study in the monkey ( Macaca mulatta) gavage doses 0, 50, 100, 200 or 300 mg/kg bw/day (single animal/group)– DHA equivalent, DHA or DHA-Na dosed. One year study, for doses up to 100 mg/kg bw/day, no adverse toxicity was evident. Adverse toxicity at 200 or 300 mg/kg bw/day. NOAEL 100 mg/kg bw/day. In a study in the rat gavage doses 10 to 300 mg/kg bw/day, 24 doses in 34 days; treatment related mortality and adverse toxicity at 300 mg/kg bw/day. No adverse effects at 0, 10, 30, 100 mg/kg bw/day. NOAEL 100 mg/kg bw/day. In a two -year study in the rat by dietary dosing, animals (25/group) were dosed at 0.02, 0.05, and 0.10 % (by weight, DHA – equivalent to 200, 500 or 1000 ppm or 20, 50 or 100 mg/kg bw/day). No adverse toxicity was seen. A NOEL of 1000 ppm (100 mg/kg bw/day) is proposed. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c342ebdc-9b8f-4b29-b6ac-e8f2d3128b14/documents/8edec5b1-02d9-49ba-90e8-b6a88f0fcb4f_d4c31e86-3043-466f-a6c8-622aea28a902.html,,,,,, "Sodium 1-(3,4-dihydro-6-methyl-2,4-dioxo-2H-pyran-3-ylidene)ethanolate",4418-26-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c342ebdc-9b8f-4b29-b6ac-e8f2d3128b14/documents/8edec5b1-02d9-49ba-90e8-b6a88f0fcb4f_d4c31e86-3043-466f-a6c8-622aea28a902.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Sodium 1-(3,4-dihydro-6-methyl-2,4-dioxo-2H-pyran-3-ylidene)ethanolate",4418-26-2, Oral: The LD50 in the mouse was 1175 mg/kg bw. The LD50 in the rat was > 1000 and <=2500 mg/kg bw. The LD50 in the rabbit was >500 and <= 1000 mg/kg bw. Dermal: The LD50 in the rabbit was considered to be greater than 3000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c342ebdc-9b8f-4b29-b6ac-e8f2d3128b14/documents/19fec48e-acfb-4e7f-bcac-fc226810a2d1_d4c31e86-3043-466f-a6c8-622aea28a902.html,,,,,, "Sodium 1-(3,4-dihydro-6-methyl-2,4-dioxo-2H-pyran-3-ylidene)ethanolate",4418-26-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c342ebdc-9b8f-4b29-b6ac-e8f2d3128b14/documents/19fec48e-acfb-4e7f-bcac-fc226810a2d1_d4c31e86-3043-466f-a6c8-622aea28a902.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, "Sodium 1-(3,4-dihydro-6-methyl-2,4-dioxo-2H-pyran-3-ylidene)ethanolate",4418-26-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c342ebdc-9b8f-4b29-b6ac-e8f2d3128b14/documents/19fec48e-acfb-4e7f-bcac-fc226810a2d1_d4c31e86-3043-466f-a6c8-622aea28a902.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, Sodium dodecylbenzenesulfonate,25155-30-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fd7734a-c4d6-4d18-aa79-a9b0c002047b/documents/IUC5-ff1bc88e-d4a1-4679-9157-e9543d3c8b3b_bf7af913-80f6-4901-a085-a39cfa37db4d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Sodium dodecylbenzenesulfonate,25155-30-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fd7734a-c4d6-4d18-aa79-a9b0c002047b/documents/IUC5-ff1bc88e-d4a1-4679-9157-e9543d3c8b3b_bf7af913-80f6-4901-a085-a39cfa37db4d.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,286 mg/kg bw/day,,rat Sodium dodecylbenzenesulfonate,25155-30-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fd7734a-c4d6-4d18-aa79-a9b0c002047b/documents/IUC5-ff1bc88e-d4a1-4679-9157-e9543d3c8b3b_bf7af913-80f6-4901-a085-a39cfa37db4d.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,4.35 mg/m3,,rat Sodium dodecylbenzenesulfonate,25155-30-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fd7734a-c4d6-4d18-aa79-a9b0c002047b/documents/IUC5-ff1bc88e-d4a1-4679-9157-e9543d3c8b3b_bf7af913-80f6-4901-a085-a39cfa37db4d.html,Repeated dose toxicity – local effects,dermal,NOAEL,1.6 mg/cm2,no adverse effect observed,rat Sodium dodecylbenzenesulfonate,25155-30-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fd7734a-c4d6-4d18-aa79-a9b0c002047b/documents/IUC5-ff1bc88e-d4a1-4679-9157-e9543d3c8b3b_bf7af913-80f6-4901-a085-a39cfa37db4d.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4.35 mg/m3,no adverse effect observed,rat Sodium dodecylbenzenesulfonate,25155-30-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fd7734a-c4d6-4d18-aa79-a9b0c002047b/documents/IUC5-ae46fa15-855e-47a9-bb86-a4768f84b62c_bf7af913-80f6-4901-a085-a39cfa37db4d.html,,oral,LD50,650 mg/kg bw,adverse effect observed, Sodium dodecylbenzenesulfonate,25155-30-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fd7734a-c4d6-4d18-aa79-a9b0c002047b/documents/IUC5-ae46fa15-855e-47a9-bb86-a4768f84b62c_bf7af913-80f6-4901-a085-a39cfa37db4d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium dodecylbenzenesulfonate,25155-30-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fd7734a-c4d6-4d18-aa79-a9b0c002047b/documents/IUC5-ae46fa15-855e-47a9-bb86-a4768f84b62c_bf7af913-80f6-4901-a085-a39cfa37db4d.html,,inhalation,LC50,310 mg/m3,no adverse effect observed, "[ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt",22036-77-7,"Admnistration of EDTMP under the conditions of this study (by gavage) resulted in neoplastic (osteosarcomas) and nonneoplastic (metaphyseal osteosclerosis) effects which were related to the administration of the test substance. There were non neoplastic effects (metaphyseal osteosclerosis) that were considered to be treatment related at the mid and high dose female group and high dose male group. NOAEL (female) = 15 mg/kg (bw), NOAEL (male) = 50 mg/kg (bw) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80426d00-85c3-498a-b469-ee47a041d227/documents/IUC5-ad24027a-0eb3-4d5d-b59d-d850c53952f3_efca83df-d939-492c-aa67-7ef55f281c16.html,,,,,, "[ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt",22036-77-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80426d00-85c3-498a-b469-ee47a041d227/documents/IUC5-ad24027a-0eb3-4d5d-b59d-d850c53952f3_efca83df-d939-492c-aa67-7ef55f281c16.html,Chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "[ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt",22036-77-7,An acute oral LD50 value of >10000 ml/kg was reported in a study conducted according to an appropriate protocol equivalent to current guideline and in compliance with GLP. The LD50 in terms of active acid was estimated to equal to >3250 mg/kg (Safepharm 1982).No data was available for acute inhalation. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80426d00-85c3-498a-b469-ee47a041d227/documents/IUC5-5423d745-e7a8-4b17-8327-76595d4e34f2_efca83df-d939-492c-aa67-7ef55f281c16.html,,,,,, "2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone",6381-77-7,"Subchronic (rat, 13 weeks): All the rats given the 2.5% and lower concentrations of 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone survived to the end of 13 weeks (Combined repeated dose and carcinogenicity study).Subchronic (mouse, 10 weeks): The maximum tolerated dose (MTD) of 2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone in drinking water was 2.5% for male mice and 5.0% for female mice (Combined repeated dose and carcinogenicity study). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a12d0a7-c1be-41be-a73f-6dc5ad47ad29/documents/IUC5-dcb99c4c-9443-4da9-8713-b44aea78a02f_37739e14-9252-4615-85bb-7bc7492b592e.html,,,,,, "2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone",6381-77-7,Acute Oral Toxicity: LD50 = >5000 mg/kg bw Acute Dermal Toxicity: LD50 = >2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a12d0a7-c1be-41be-a73f-6dc5ad47ad29/documents/IUC5-5027fdc9-7e66-4f2e-9654-518dd1d92f74_37739e14-9252-4615-85bb-7bc7492b592e.html,,,,,, "2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone",6381-77-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a12d0a7-c1be-41be-a73f-6dc5ad47ad29/documents/IUC5-5027fdc9-7e66-4f2e-9654-518dd1d92f74_37739e14-9252-4615-85bb-7bc7492b592e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,3-didehydro-3-O-sodio-D-erythro-hexono-1,4-lactone",6381-77-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a12d0a7-c1be-41be-a73f-6dc5ad47ad29/documents/IUC5-5027fdc9-7e66-4f2e-9654-518dd1d92f74_37739e14-9252-4615-85bb-7bc7492b592e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 2-sulphonatoethyl laurate,7381-01-3,"The repeated-dose toxicity of SLI by the oral and dermal routes has been assessed using studies on the read-across source compound, SCI.   By the oral route, SCI (Jordapon CI) was evaluated in rats in a study compliant with GLP and conducted by a method equivalent to OECD Test Guideline 407. Groups of 10 rats/sex had ad libitum access to diets containing 0.0, 0.1, 0.3 or 1.0% Jordapon CI for 28 days. No animals died or were killed on humane grounds during the study. No clinical signs attributable to treatment were observed. A few minor, but statistically significant changes, were recorded in body weight gains during the first half of the study but no consistent treatment-related changes were observed throughout the study. Food and water consumption were decreased slightly in female rats throughout the study period, but this did not result in any significant changes in the absolute body weights. The only macroscopic change showing a treatment-related distribution was an alteration in the colour of the caecal contents of male rats fed test item; this was considered to be incidental and of no toxicological significance. No microscopic findings considered to be related to the feeding of test item were observed.   The no-observed-adverse-effect level (NOAEL) in this study was considered to be 1% Jordapon CI in the diet (10,000 ppm), the highest dose tested. Based on the terminal body weights and food consumption, this dose converts to a health-precautionary NOAEL of 627 mg/kg bw/day for DNEL derivation purposes.   The short-term dermal toxicity of SCI to rats was evaluated in a study conducted according to OECD Test Guideline 410 and compliant with GLP. The test item was applied to an area of clipped dorsal skin corresponding to approximately 10% of the body surface area, for 6 hours/day on 28 consecutive days. SCI concentrations of 0, 1, 14 and 36% were used, which corresponded to 0, 80, 910 and 2070 mg/kg bw/day. There were no adverse local or systemic effects related to treatment. The no-observed-adverse-effect level was 36% (w/w), which provided a dose of 2070 mg/kg bw/day.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cde25bc-d6d2-4340-8382-c6bf186d30e8/documents/ac83c3f4-75c5-4b74-9a02-9758f4e531f1_231eb94f-7748-48de-be52-5897b3fe5316.html,,,,,, Sodium 2-sulphonatoethyl laurate,7381-01-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cde25bc-d6d2-4340-8382-c6bf186d30e8/documents/ac83c3f4-75c5-4b74-9a02-9758f4e531f1_231eb94f-7748-48de-be52-5897b3fe5316.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,627 mg/kg bw/day,,rat Sodium 2-sulphonatoethyl laurate,7381-01-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cde25bc-d6d2-4340-8382-c6bf186d30e8/documents/ac83c3f4-75c5-4b74-9a02-9758f4e531f1_231eb94f-7748-48de-be52-5897b3fe5316.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,070 mg/kg bw/day",,rat Sodium 2-sulphonatoethyl laurate,7381-01-3,"The acute oral toxicity of ELFAN AT 84, was investigated in a group of five male and five female CD rats at a dosage of 2000 mg/kg. The animals were starved overnight prior to dosing. The test material was administered at a volume-dosage of 20 ml/kg in purified water. Mortality and signs of reaction to treatment were recorded during a subsequent 14-day observation period. The animals were killed on the following day and subjected to necropsy. There was no death and no sign of reaction to treatment. All animals achieved expected bodyweight gains and necropsy revealed no significant macroscopic lesion. Under the conditions of this study, the LD50 of the test material was greater than 2000 mg/kg and based on these data it was not classified for acute oral toxicity.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cde25bc-d6d2-4340-8382-c6bf186d30e8/documents/ff2058c3-6056-4cdf-9bca-e0d7e042ec67_231eb94f-7748-48de-be52-5897b3fe5316.html,,,,,, Sodium 2-sulphonatoethyl laurate,7381-01-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cde25bc-d6d2-4340-8382-c6bf186d30e8/documents/ff2058c3-6056-4cdf-9bca-e0d7e042ec67_231eb94f-7748-48de-be52-5897b3fe5316.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Sodium etasulfate,126-92-1,For the whole category of alkyl sulfates (AS) a NOAEL of 488 mg/kg bw/day for oral and dermal exposure was established. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7707aa6c-68e4-4225-b642-3fdf89950a90/documents/IUC5-0c643b27-1c23-44bd-81d1-390e622a7b7d_d812fa07-fe4c-4a47-825e-27da64fc4d4c.html,,,,,, Sodium etasulfate,126-92-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7707aa6c-68e4-4225-b642-3fdf89950a90/documents/IUC5-0c643b27-1c23-44bd-81d1-390e622a7b7d_d812fa07-fe4c-4a47-825e-27da64fc4d4c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,488 mg/kg bw/day,,rat Sodium etasulfate,126-92-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7707aa6c-68e4-4225-b642-3fdf89950a90/documents/IUC5-0c643b27-1c23-44bd-81d1-390e622a7b7d_d812fa07-fe4c-4a47-825e-27da64fc4d4c.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,,mouse Sodium etasulfate,126-92-1,"Oral LD50 (OECD guideline 401), rat 2840 mg/kg bwDermal LD50 (OECD guideline 402), rabbit > 2000 mg/kg bw (limit test) Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7707aa6c-68e4-4225-b642-3fdf89950a90/documents/IUC5-242e9cd0-2c22-461f-84cc-2c9cfbff123b_d812fa07-fe4c-4a47-825e-27da64fc4d4c.html,,,,,, Sodium etasulfate,126-92-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7707aa6c-68e4-4225-b642-3fdf89950a90/documents/IUC5-242e9cd0-2c22-461f-84cc-2c9cfbff123b_d812fa07-fe4c-4a47-825e-27da64fc4d4c.html,,oral,LD50,"2,840 mg/kg bw",adverse effect observed, Sodium etasulfate,126-92-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7707aa6c-68e4-4225-b642-3fdf89950a90/documents/IUC5-242e9cd0-2c22-461f-84cc-2c9cfbff123b_d812fa07-fe4c-4a47-825e-27da64fc4d4c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 4-ethoxycarbonylphenoxide,35285-68-8,"The test item was tested for its acute oral toxicity potential. 5 male and 5 female rats were treated with doses of 1000, 3100 or 5000 mg/kg bw and observed for 14 days.The median lethal dose of test item (LD50) was 3100 mg per kg body weight. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12b3f387-9b25-47a2-87bb-c02db03cf1cd/documents/IUC5-8deb03db-8d74-4d63-97af-b983b29f6385_2b607ec8-785a-4105-9293-c2795444302b.html,,,,,, Sodium 4-ethoxycarbonylphenoxide,35285-68-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12b3f387-9b25-47a2-87bb-c02db03cf1cd/documents/IUC5-8deb03db-8d74-4d63-97af-b983b29f6385_2b607ec8-785a-4105-9293-c2795444302b.html,,oral,LD50,"3,100 mg/kg bw",no adverse effect observed, Tetrasodium hexacyanoferrate,13601-19-9,"In a long term (two year) repeated dose toxicity study with rats, supplemented with two interim studies (49-51 weeks and 80-82 weeks respectively), the NOAEL was determined to be ≥ 630 and ≥ 450 mg/kg bw/day for females and males, respectively, based on the absence of effects seen at the highest concentration (5000 ppm in the food). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b00c2ae-6428-4d29-ba77-e283866d2463/documents/IUC5-f35c88c9-c2e2-4683-85b5-c8557e0569f2_8b64333b-7ced-401a-8198-8c963cee8461.html,,,,,, Tetrasodium hexacyanoferrate,13601-19-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b00c2ae-6428-4d29-ba77-e283866d2463/documents/IUC5-f35c88c9-c2e2-4683-85b5-c8557e0569f2_8b64333b-7ced-401a-8198-8c963cee8461.html,Chronic toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat Tetrasodium hexacyanoferrate,13601-19-9,"Acute oral and dermal toxicity studies are available, performed similar to or according to OECD test guidelines respectively. The LD50 values are > 2000 mg/kg bw for both studies. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b00c2ae-6428-4d29-ba77-e283866d2463/documents/IUC5-f51f3dbc-a3be-4403-9e8d-3a7349405bb3_8b64333b-7ced-401a-8198-8c963cee8461.html,,,,,, Tetrasodium hexacyanoferrate,13601-19-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b00c2ae-6428-4d29-ba77-e283866d2463/documents/IUC5-f51f3dbc-a3be-4403-9e8d-3a7349405bb3_8b64333b-7ced-401a-8198-8c963cee8461.html,,oral,LD50,"5,110 mg/kg bw",no adverse effect observed, Tetrasodium hexacyanoferrate,13601-19-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b00c2ae-6428-4d29-ba77-e283866d2463/documents/IUC5-f51f3dbc-a3be-4403-9e8d-3a7349405bb3_8b64333b-7ced-401a-8198-8c963cee8461.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium fluoride,7681-49-4,"In rodents, repeated exposure to fluoride salts, such as sodium fluoride, causes alteration of teeth at daily doses of 4 mg NaF/kg bw/day or greater.  Higher repeated doses of 10 and 25 mg NaF/kg bw/day increase dental effects as well as cause toxic effects in bone and the stomach.  The severity of the toxic effects is related to increasing dose and duration of exposure.  In a life-time chronic exposure study in the rats, an extremely high concentration of 175 ppm sodium fluoride in drinking water was associated with an increased incidence of osteosclerosis in female rats and equivocal evidence of osteosarcoma in male rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92eff68f-f83c-4380-82a3-cbfc7178e71c/documents/7a305cf8-5c1a-40a7-8196-0980dc8fc9aa_bb985548-a5fa-4411-8b83-6731e12f172e.html,,,,,, Sodium fluoride,7681-49-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92eff68f-f83c-4380-82a3-cbfc7178e71c/documents/7a305cf8-5c1a-40a7-8196-0980dc8fc9aa_bb985548-a5fa-4411-8b83-6731e12f172e.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,10 mg/kg bw/day,, Sodium fluoride,7681-49-4,"Based on the reported acute oral and inhalation LD50 values for sodium fluoride in experimental animals, sodium fluoride is considered moderately toxic if ingested or inhaled.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92eff68f-f83c-4380-82a3-cbfc7178e71c/documents/4b7ea36c-bcdd-4dc5-8ffb-02488f1e1585_bb985548-a5fa-4411-8b83-6731e12f172e.html,,,,,, Sodium fluoride,7681-49-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92eff68f-f83c-4380-82a3-cbfc7178e71c/documents/4b7ea36c-bcdd-4dc5-8ffb-02488f1e1585_bb985548-a5fa-4411-8b83-6731e12f172e.html,,oral,LD50,148.5 mg/kg bw,, Sodium fluoride,7681-49-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92eff68f-f83c-4380-82a3-cbfc7178e71c/documents/4b7ea36c-bcdd-4dc5-8ffb-02488f1e1585_bb985548-a5fa-4411-8b83-6731e12f172e.html,,dermal,LD50,"> 2,000 mg/kg bw",, Sodium fluoride,7681-49-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92eff68f-f83c-4380-82a3-cbfc7178e71c/documents/4b7ea36c-bcdd-4dc5-8ffb-02488f1e1585_bb985548-a5fa-4411-8b83-6731e12f172e.html,,inhalation,LC50,0.64 mg/L,, Disodium hexafluorosilicate,16893-85-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe0a6461-65f5-4abc-baa3-16354653bb17/documents/IUC5-188da1cb-7e2f-4274-ab6a-8015a1f7608b_e212549e-f327-4097-9275-4d5f0fd9e6aa.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Disodium hexafluorosilicate,16893-85-9,Reliable information on acute inhalation toxicity indicates that the substance shall be classified according to in force regulations. Some non-standard acute oral toxicity studies as well as information on structurally related substance are available and are reported. This data also indicates that the substance shall be classified according to in force regulations. Waivers are appropriate for acute dermal toxicity as it is not a relevant exposure route. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe0a6461-65f5-4abc-baa3-16354653bb17/documents/IUC5-1b7dbe83-4f2d-4c1a-9306-d4bf147aab0e_e212549e-f327-4097-9275-4d5f0fd9e6aa.html,,,,,, Disodium hexafluorosilicate,16893-85-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe0a6461-65f5-4abc-baa3-16354653bb17/documents/IUC5-1b7dbe83-4f2d-4c1a-9306-d4bf147aab0e_e212549e-f327-4097-9275-4d5f0fd9e6aa.html,,oral,LD50,70 mg/kg bw,, Disodium hexafluorosilicate,16893-85-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe0a6461-65f5-4abc-baa3-16354653bb17/documents/IUC5-1b7dbe83-4f2d-4c1a-9306-d4bf147aab0e_e212549e-f327-4097-9275-4d5f0fd9e6aa.html,,inhalation,LC50,"1,814 mg/m3",, Sodium formate,141-53-7, Repeated dose oral toxicity data in the rat are available for the read-across substance potassium formate. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29f42b58-be56-49d8-8503-02c9f19aa4a0/documents/a6af71c5-e00d-45b7-898f-dd0c12896fe7_7de5e0e3-5bdc-456e-86c0-a9e8458dc6e5.html,,,,,, Sodium formate,141-53-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29f42b58-be56-49d8-8503-02c9f19aa4a0/documents/a6af71c5-e00d-45b7-898f-dd0c12896fe7_7de5e0e3-5bdc-456e-86c0-a9e8458dc6e5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,138 mg/kg bw/day",,rat Sodium formate,141-53-7," Studies of acute oral, dermal and inhalation toxicity are available for sodium formate. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29f42b58-be56-49d8-8503-02c9f19aa4a0/documents/c1acacc2-85d6-421f-bb03-f9c04d7f5395_7de5e0e3-5bdc-456e-86c0-a9e8458dc6e5.html,,,,,, Sodium formate,141-53-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29f42b58-be56-49d8-8503-02c9f19aa4a0/documents/c1acacc2-85d6-421f-bb03-f9c04d7f5395_7de5e0e3-5bdc-456e-86c0-a9e8458dc6e5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium formate,141-53-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29f42b58-be56-49d8-8503-02c9f19aa4a0/documents/c1acacc2-85d6-421f-bb03-f9c04d7f5395_7de5e0e3-5bdc-456e-86c0-a9e8458dc6e5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium formate,141-53-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29f42b58-be56-49d8-8503-02c9f19aa4a0/documents/c1acacc2-85d6-421f-bb03-f9c04d7f5395_7de5e0e3-5bdc-456e-86c0-a9e8458dc6e5.html,,inhalation,LC50,670 mg/m3,no adverse effect observed, Sodium D-glycero-D-gulo-heptonate,13007-85-7,"The oral administration to rats of Sodium Glucoheptanate (EC 250-480-2) (incorporating a test item correction factor for 50.5% w/w purity minus 49.5% w/w test item water content) to rats by gavage, at dose levels of 30, 300 and 1000 mg/kg bw/day did not produce any convincing toxicological effects of treatment and on this basis the ‘No Observed Adverse Effect Level’ (NOAEL) and possible ‘No Observed Effect Level’ (NOEL) for systemic toxicity for either sex was considered to be 1000 mg/kg bw/day.No treatment-related effects were observed for reproduction, the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was therefore considered to be 1000 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1f6a7076-82d9-4fc7-85b5-e5d5b6846a41/documents/IUC5-9663f814-0249-43a4-8ac9-244bfe894c20_f92a53ac-2f2d-4cf3-8afa-cb1ed01127a9.html,,,,,, Sodium D-glycero-D-gulo-heptonate,13007-85-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1f6a7076-82d9-4fc7-85b5-e5d5b6846a41/documents/IUC5-9663f814-0249-43a4-8ac9-244bfe894c20_f92a53ac-2f2d-4cf3-8afa-cb1ed01127a9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium D-glycero-D-gulo-heptonate,13007-85-7,An acute oral toxicity and an acute dermal toxicty study have been conducted. Acute oral toxicity: LD50 >2000 mg/kg bwAcute dermal toxicity: LD50 >2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f6a7076-82d9-4fc7-85b5-e5d5b6846a41/documents/IUC5-b0c04a39-d230-45b6-aa28-e3ec2b4f64e8_f92a53ac-2f2d-4cf3-8afa-cb1ed01127a9.html,,,,,, Sodium D-glycero-D-gulo-heptonate,13007-85-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f6a7076-82d9-4fc7-85b5-e5d5b6846a41/documents/IUC5-b0c04a39-d230-45b6-aa28-e3ec2b4f64e8_f92a53ac-2f2d-4cf3-8afa-cb1ed01127a9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium D-glycero-D-gulo-heptonate,13007-85-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f6a7076-82d9-4fc7-85b5-e5d5b6846a41/documents/IUC5-b0c04a39-d230-45b6-aa28-e3ec2b4f64e8_f92a53ac-2f2d-4cf3-8afa-cb1ed01127a9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium glucoheptonate,31138-65-5,"The oral administration to rats of Sodium Glucoheptanate (EC 250-480-2) (incorporating a test item correction factor for 50.5% w/w purity minus 49.5% w/w test item water content) to rats by gavage, at dose levels of 30, 300 and 1000 mg/kg bw/day did not produce any convincing toxicological effects of treatment and on this basis the ‘No Observed Adverse Effect Level’ (NOAEL) and possible ‘No Observed Effect Level’ (NOEL) for systemic toxicity for either sex was considered to be 1000 mg/kg bw/day.No treatment-related effects were observed for reproduction, the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was therefore considered to be 1000 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c4a2c50-57f3-456b-87dd-986b687c9701/documents/IUC5-35f1fd32-b651-41ac-a617-ff6533815454_e855ba87-2480-4278-821d-848ba2fb8c5f.html,,,,,, Sodium glucoheptonate,31138-65-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c4a2c50-57f3-456b-87dd-986b687c9701/documents/IUC5-35f1fd32-b651-41ac-a617-ff6533815454_e855ba87-2480-4278-821d-848ba2fb8c5f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium glucoheptonate,31138-65-5,The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was found to be greater than 4040 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight).The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 4041 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c4a2c50-57f3-456b-87dd-986b687c9701/documents/IUC5-5d421692-dcd5-4717-a380-5ac6a13b1a3d_e855ba87-2480-4278-821d-848ba2fb8c5f.html,,,,,, Sodium glucoheptonate,31138-65-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c4a2c50-57f3-456b-87dd-986b687c9701/documents/IUC5-5d421692-dcd5-4717-a380-5ac6a13b1a3d_e855ba87-2480-4278-821d-848ba2fb8c5f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium glucoheptonate,31138-65-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c4a2c50-57f3-456b-87dd-986b687c9701/documents/IUC5-5d421692-dcd5-4717-a380-5ac6a13b1a3d_e855ba87-2480-4278-821d-848ba2fb8c5f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium hydrogen glutamate,142-47-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e8ad084-41c3-44fa-91bf-42e2a2a5041b/documents/IUC5-2b139b24-3a49-4b1d-8f65-f22373891d81_e0df72a2-0e85-487c-98bb-0ce960679ff4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,500 mg/kg bw/day",,dog Sodium hydrogen glutamate,142-47-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e8ad084-41c3-44fa-91bf-42e2a2a5041b/documents/IUC5-3bf5bd9f-8ff6-42a3-955e-96c920e842d8_e0df72a2-0e85-487c-98bb-0ce960679ff4.html,,oral,LD50,"2,000 mg/kg bw",, Sodium hydrogen glutamate,142-47-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e8ad084-41c3-44fa-91bf-42e2a2a5041b/documents/IUC5-3bf5bd9f-8ff6-42a3-955e-96c920e842d8_e0df72a2-0e85-487c-98bb-0ce960679ff4.html,,dermal,LD50,"2,000 mg/kg bw",, Sodium glycinate,6000-44-8," NOAEL (male, oral, glycine) ≥ 2000 mg/kg bw/d (28 days) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1480a9e0-09f4-4ef7-b721-a34f5ed5e7cc/documents/6097c386-ebdf-404d-8454-5c04df51f317_f5f51555-05bc-41e8-8a2a-f1a5985822e6.html,,,,,, Sodium glycinate,6000-44-8," Oral: Hazard assessment is based on the weight of evidence from all available studies. LD50 (oral) rat, male/female: 9550/7930 mg/kg bw LD50 (oral) mice, male/female: 5640/4920 mg/kg bw Inhalation: No study is required since exposure of humans via inhalation is unlikely based on the low vapor pressure. Dermal: No study is required since exposure of humans via skin is unlikely based on the physio-chemical properties of sodium glycinate (see read across document). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1480a9e0-09f4-4ef7-b721-a34f5ed5e7cc/documents/f1da41b1-5d77-4cfc-b6b6-c1dcd3a82957_f5f51555-05bc-41e8-8a2a-f1a5985822e6.html,,,,,, Sodium metaphosphate,10124-56-8,"Repeated dose toxicity: oral;Four studies are available for this endpoint:- A key study (Hodge HC 1960) performed in rats demonstrates that there is not specific target organ toxicity when administered ad libitum in the diets of male and female rats for a period of 2 years. The data for this key study are sufficient to infer that that test material should not be classified for STOT-RE under the EU CLP Regulation. A toxicologist expert assessment of the key study is provided to support this conclusion.- There are also three supporting studies which support the findings of the key study for 90 day and 28 day testing periods. Above the thresholds for classification no target organ toxicity was noted at gross necroscopy.Based on exposure considerations (to be presented in the CSR), and the toxicokinetic and physicochemical properties of the test substance it was considered to be scientifically justifiable to waive in vivo testing for inhalation and dermal repeat dose administration. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fea156c-aecd-4b01-9518-bcc3b1cbdf0f/documents/IUC5-02f96e8b-755f-4577-8d02-68e82f30e78a_b42d6e43-1469-4dce-b800-4876c1d2f792.html,,,,,, Sodium metaphosphate,10124-56-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fea156c-aecd-4b01-9518-bcc3b1cbdf0f/documents/IUC5-02f96e8b-755f-4577-8d02-68e82f30e78a_b42d6e43-1469-4dce-b800-4876c1d2f792.html,Chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Sodium metaphosphate,10124-56-8,"Acute oral toxicity: Three studies are available for the acute oral toxicity endpoint. All studies indicate that sodium hexametaphosphate has a low potential for systemic toxicity following acute administration via the oral route. The key study (Bradshaw, 2010) has been conducted to a current guideline (OECD 420) and according to GLP. The acute oral median dose (LD50) of sodium hexametaphosphate in the female Wistar strain rat was estimated to be greater that 2000 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP). This conclusion is supported by the additional data provided for this endpoint.Acute inhalation toxicity: One key study is available to assess the acute inhalation toxicity of sodium metaphosphate. Sodium metaphosphate was considered to exhibit a low potential toxicity via the inhalation route and is not expected to be of significant concern. The key study (Signorin J, 1993) has been conducted according to the relevant guidelines (EU and US) and according to the principles of GLP. The acute inhalation median concentration (LC50) of sodium metaphosphate in male and female rats was estimated to be > 3.69 mg/L (the maximum attainable concentration). Acute dermal toxicity: Testing was waived on the basis that further in vivo testing is considered to be scientifically unjustified. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fea156c-aecd-4b01-9518-bcc3b1cbdf0f/documents/IUC5-8a8e1163-fb58-4f5a-873a-1f3ce4115e14_b42d6e43-1469-4dce-b800-4876c1d2f792.html,,,,,, "Humic acids, sodium salts",68131-04-4,"EU method B.7. Repeated Dose (28-days) Toxicity (Oral), Directive 96/54/EC, published in OJ L 248, 1996. GLP study ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1912148-29cf-446d-869c-a2e6a20b6e36/documents/IUC5-c6251a60-d7d6-4623-89bc-8d9e343b51e8_6a289a6f-e1f8-41a6-8114-615047121734.html,,,,,, "Humic acids, sodium salts",68131-04-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1912148-29cf-446d-869c-a2e6a20b6e36/documents/IUC5-c6251a60-d7d6-4623-89bc-8d9e343b51e8_6a289a6f-e1f8-41a6-8114-615047121734.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,, "Humic acids, sodium salts",68131-04-4,"The tests of Acute oral toxicity and Acute dermal toxicity were performed according to the following methods: Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Directive 2004/73/EC, published in O.J. L152, 2004.Method B.3 Acute Toxicity (Dermal), Directive 92/69/EEC, published in OJ L 383A, 1992.Both: GLP study ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1912148-29cf-446d-869c-a2e6a20b6e36/documents/IUC5-94ee5c12-fa9a-4c16-8f00-fe03bcd53c50_6a289a6f-e1f8-41a6-8114-615047121734.html,,,,,, "Humic acids, sodium salts",68131-04-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1912148-29cf-446d-869c-a2e6a20b6e36/documents/IUC5-94ee5c12-fa9a-4c16-8f00-fe03bcd53c50_6a289a6f-e1f8-41a6-8114-615047121734.html,,oral,LD50,"2,000 mg/kg bw",, "Humic acids, sodium salts",68131-04-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1912148-29cf-446d-869c-a2e6a20b6e36/documents/IUC5-94ee5c12-fa9a-4c16-8f00-fe03bcd53c50_6a289a6f-e1f8-41a6-8114-615047121734.html,,dermal,LD50,"2,000 mg/kg bw",, Sodium dithionite,7775-14-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5d8ea39-28d3-4ebd-9869-6d6b8937b106/documents/IUC5-835317f7-b049-49c4-9810-a423e25be6ce_5a814391-5c89-4e76-ada2-157993505f87.html,Chronic toxicity – systemic effects,oral,NOAEL,99 mg/kg bw/day,,rat Sodium hydroxide,1310-73-2,"The introductory sections to Annexes VII-X point at a specific adaptation to the standard information requirements as in vivo testing shall be avoided with corrosive substances at concentration/dose levels causing corrosivity. However, NaOH is not expected to be systemically available in the body under normal handling and use conditions and therefore systemic effects of NaOH after repeated exposure are not expected to occur (EU RAR of sodium hydroxide (2007); section 4.1.3.1.4, page 76). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09a61d64-0c49-49cb-9689-3efe12d28759/documents/IUC5-e4d02d24-1cff-4b39-ad6c-3817321502f5_f0c31360-2127-4bbb-979c-50adccd46f0e.html,,,,,, Sodium hydroxide,1310-73-2,"No reliable studies are available for acute toxicity to NaOH. According to the REACH Regulation, acute toxicity testing does not generally need to be conducted if the substance is classified as corrosive to the skin (column 2 adaptation, Annex VIII). NaOH is a corrosive substance and for this reason there is no need for further acute toxicity testing (EU RAR, 2007; section 4.1.2.2.3, page 65). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09a61d64-0c49-49cb-9689-3efe12d28759/documents/IUC5-4dd1d5df-e116-4e4d-8125-7dd7f83beaee_f0c31360-2127-4bbb-979c-50adccd46f0e.html,,,,,, Sodium N-(hydroxymethyl)glycinate,70161-44-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP compliant study resulting in a NOAEL supported by a 28-day repeated dose test. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2f3f714-371e-4f88-92ab-dbd0ebd85637/documents/IUC5-5a105adf-7b0a-4462-8b3d-6ed4d58ecd5e_21473204-856c-456a-bc45-778e0babbe9f.html,,,,,, Sodium N-(hydroxymethyl)glycinate,70161-44-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2f3f714-371e-4f88-92ab-dbd0ebd85637/documents/IUC5-5a105adf-7b0a-4462-8b3d-6ed4d58ecd5e_21473204-856c-456a-bc45-778e0babbe9f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,160 mg/kg bw/day,,rat Sodium N-(hydroxymethyl)glycinate,70161-44-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): In three different studies the LD50 values ranged between 940 and 1400 mg/kg bw. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Both studies used in this dossier for the acute inhalation endpoint had been performed under GLP according to internationally accepted guidelines. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Both studies support the key value, of which one was performed under GLP. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2f3f714-371e-4f88-92ab-dbd0ebd85637/documents/IUC5-0502cc53-5a3b-4466-875c-75b6380661be_21473204-856c-456a-bc45-778e0babbe9f.html,,,,,, Sodium N-(hydroxymethyl)glycinate,70161-44-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2f3f714-371e-4f88-92ab-dbd0ebd85637/documents/IUC5-0502cc53-5a3b-4466-875c-75b6380661be_21473204-856c-456a-bc45-778e0babbe9f.html,,oral,LD50,940 mg/kg bw,adverse effect observed, Sodium N-(hydroxymethyl)glycinate,70161-44-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2f3f714-371e-4f88-92ab-dbd0ebd85637/documents/IUC5-0502cc53-5a3b-4466-875c-75b6380661be_21473204-856c-456a-bc45-778e0babbe9f.html,,dermal,discriminating dose,"2,000 mg/kg bw",adverse effect observed, Sodium N-(hydroxymethyl)glycinate,70161-44-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2f3f714-371e-4f88-92ab-dbd0ebd85637/documents/IUC5-0502cc53-5a3b-4466-875c-75b6380661be_21473204-856c-456a-bc45-778e0babbe9f.html,,inhalation,LC50,"3,000 mg/m3",adverse effect observed, Sodium hypochlorite,7681-52-9,"Key study (oral): There were no mortalities throughout a 90 day study with rats. Body weight gain was statistically significantly reduced in males at 100 and 200 mg/kg bw/day dose level groups and in females at 228.8 mg/kg bw/day dose level group (Hasegawa et al., 1986); there were no obvious macroscopic or histological changes in any group. A NOAEL of 50 mg/kg bw/day was identified. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce7802d1-52a1-4ec5-9a28-be9950d5892d/documents/IUC5-f7439d07-905e-4072-a456-eb6173789ded_83d19d9c-0ef3-4453-8cad-a1b59cde2c24.html,,,,,, Sodium hypochlorite,7681-52-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce7802d1-52a1-4ec5-9a28-be9950d5892d/documents/IUC5-f7439d07-905e-4072-a456-eb6173789ded_83d19d9c-0ef3-4453-8cad-a1b59cde2c24.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Sodium hypochlorite,7681-52-9,"Waiving of study:In accordance with column 2 of REACH Annex VII and VIII, acute toxicity studies (required in section 8.5) does not need to be conducted because the substance is classified as corrosive to the skin.Supporting studies:The Kaestner data is considered of higher reliability, and it is based on the rat, the standard animal, contrary to the Momma study which used mice. The LD50 and LD0 values were calculated as follows:LD50= 12.5% (% of available Cl2 in sol.) x 8.83 (g/kg BW LD50 of the sol. to male rat) = 1.1 g/kg BW (LD50 as available Cl2) = 1100 mg/kg BW NaClO as av. Cl2LD0= 12.5% (% of available Cl2 in sol.) x 5.01 (g/kg LD50 of the sol. to male rat) 0.626 g/kg BW (LD50 as available Cl2) = 626 mg/kg BW NaClO as av. Cl2In a acute dermal toxicity study, animals showed signs of moderate to severe skin irritation. The dermal LD50 was determined to be greater than 20 g/kg bw (corresponding to 2500 mg avCl/kg bw).In the acute inhalation toxicity study, generalised inactivity and lacrimation were evident at the dose of 10.5 mg av Cl/L. The LC50 was determined to be greater than 10.5 mg av Cl/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce7802d1-52a1-4ec5-9a28-be9950d5892d/documents/IUC5-27397e16-fee3-4123-bd31-b641cd181eba_83d19d9c-0ef3-4453-8cad-a1b59cde2c24.html,,,,,, Sodium hypochlorite,7681-52-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce7802d1-52a1-4ec5-9a28-be9950d5892d/documents/IUC5-27397e16-fee3-4123-bd31-b641cd181eba_83d19d9c-0ef3-4453-8cad-a1b59cde2c24.html,,oral,LD50,"1,100 mg/kg bw",, Sodium hypochlorite,7681-52-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce7802d1-52a1-4ec5-9a28-be9950d5892d/documents/IUC5-27397e16-fee3-4123-bd31-b641cd181eba_83d19d9c-0ef3-4453-8cad-a1b59cde2c24.html,,dermal,LD50,"2,500 mg/kg bw",, Sodium hypochlorite,7681-52-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce7802d1-52a1-4ec5-9a28-be9950d5892d/documents/IUC5-27397e16-fee3-4123-bd31-b641cd181eba_83d19d9c-0ef3-4453-8cad-a1b59cde2c24.html,,inhalation,LC50,"10,500 mg/m3",, Sodium iodate,7681-55-2," The Merck Index, Cosmetic Ingredient review, Lent et al (2017) The acute oral LD50 of the substance to mice was reported to be 505 mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71aeba52-bedc-4886-9bdf-cb3f9bd6891c/documents/d78293f9-a13a-42b6-9e90-68757e2d47b5_32288499-67c5-49d2-9b8a-9eeec7f23639.html,,,,,, Sodium iodate,7681-55-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71aeba52-bedc-4886-9bdf-cb3f9bd6891c/documents/d78293f9-a13a-42b6-9e90-68757e2d47b5_32288499-67c5-49d2-9b8a-9eeec7f23639.html,,oral,LD50,505 mg/kg bw,adverse effect observed, Sodium iodide,7681-82-5,"Repeated dose toxicity: Oral (key study) In a 2-year chronic toxicity study with F344 rats with potassium iodide, which share the same active ingredient as the substance (i.e. iodide), the LOAEL in male and female rats was established at 10 ppm (approx 0.55 mg/kg/day in males; and 0.66 mg/kg/day in females) due to increased incidences of thyroid follicular dilatation. These lesions were characterised by increased colloid in the lumen and flattened epithelial layer due to compression. Increased mortality rates were observed in male rats treated at 100 and 1000 ppm, but not in female rats treated at 100 or 1000 ppm. The cause of death in male rats could not be established however compression of the respiratory tract due to thyroid enlargement was ruled out since thyroid follicular dilatation at 10 ppm and above did not show a marked thyroidal enlargement. Lower body weights were observed at 1000 ppm (both genders). No significant changes in water intake or hematology were observed. The full histopathological examination that was performed in the study revealed thyroid follicular dilatation at 10 ppm, as mentioned above, and focal acinar atrophy, ductular proliferation and squamous metaplasias in the salivary gland at 1000 ppm. Significant/severe toxicological effects that would justify a classification for STOT RE were considered to have been observed at 100 ppm in males (about 5.31 mg/kg/day) and 1000 ppm in both genders (males; about 53.03 mg/kg/day; females about 66.59 mg/kg/day). Conversions from ppm to mg/kg/day was as per authors calculations in the study report. The study was well-documented, met generally accepted scientific standards and was considered acceptable for assessment (Klimisch 2).   Repeated dose toxicity: Oral (supporting study) In a study performed according to OECD 407 with Wistar rats with the Substance, the NOAEL in female rats was established at 150 mg/kg bw/day whereas the NOAEL in male rats could not be established due to significant decreases in body weight at doses of 37.5 mg/kg bw/day and above. The body weight effects at 37.5 mg/kg bw/day and above showed evidence of reversibility after cessation of treatment. The body weight effects observed in males at 37.5 mg/kg bw/day and above were not considered to be significant/severe toxicological effects that would justify a classification for STOT RE since there was evidence of reversibility during and after treatment. The study was performed according to OECD 407 (2008) and GLP (Klimisch 1).   Repeated dose toxicity: Oral (supporting study) Potassium iodide, which share the same active ingredient as the Substance (i.e. iodide) was given to 20 male rats per dietary dose level at 0 and 1000 ppm (approx. 50 mg/kg bw/day) for 19 weeks. At the end of the treatment period, blood samples were collected from each rat for the assessment of serum concentrations of TSH, T4 and T3. At necropsy, the thyroid of each rat was removed, weighed, and fixed in buffered formalin for serial sectioning. No mortality was observed during the study period. No significant effect was observed on the terminal body weight of the animals (mean, 319 g at 1000 ppm vs. mean, 318 g at 0 ppm). The absolute and relative weight of the thyroid was unaffected by treatment, as was the absolute and relative weight of the liver. No significant effects were observed on the serum concentrations of TSH, T4 and T3. Histological changes of the thyroid were confined to diffused large follicles and flattened follicular epithelium at 1000 ppm. LOAEL was therefore considered to be 1000 ppm (approx. 50 mg/kg bw/day) in male rats in this 19 -week study. The study was well-documented, met generally accepted scientific standards and was considered acceptable for assessment (Klimisch 2).   Repeated dose toxicity: Inhalation According to column 2 of Annex VIII, exposure by inhalation route is negligible due to the very low vapour pressure of NaI (which is found to be 0.9 mm Hg as mentioned in the relevant end point) on account of high boiling points (as has been informed in the boiling point end point that is 1304 °C).   Repeated dose toxicity: Dermal The acute dermal toxicity value for Sodium iodide (CAS no. 7681-82-5) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/50562704-4829-4885-8883-483a301f6808/documents/a58415a7-0687-41b8-aff0-14782dae859b_7555e46d-b16b-44bd-a3b2-2e3aa12b6d69.html,,,,,, Sodium iodide,7681-82-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/50562704-4829-4885-8883-483a301f6808/documents/a58415a7-0687-41b8-aff0-14782dae859b_7555e46d-b16b-44bd-a3b2-2e3aa12b6d69.html,Chronic toxicity – systemic effects,oral,LOAEL,0.55 mg/kg bw/day,,rat Sodium iodide,7681-82-5,"Acute oral toxicity:    The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.   Acute Inhalation Toxicity:   The acute Inhalation toxicity dose (LC50) was considered based on different studies conducted on rats for the test chemical. The LC50 value is >5000 mg/m3, for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute inhalation toxicity. Acute Dermal toxicity:   The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50562704-4829-4885-8883-483a301f6808/documents/65e7393a-bc93-432a-8f21-fe253faed9fa_7555e46d-b16b-44bd-a3b2-2e3aa12b6d69.html,,,,,, Sodium iodide,7681-82-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50562704-4829-4885-8883-483a301f6808/documents/65e7393a-bc93-432a-8f21-fe253faed9fa_7555e46d-b16b-44bd-a3b2-2e3aa12b6d69.html,,oral,LD50,"4,340 mg/kg bw",no adverse effect observed, Sodium iodide,7681-82-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50562704-4829-4885-8883-483a301f6808/documents/65e7393a-bc93-432a-8f21-fe253faed9fa_7555e46d-b16b-44bd-a3b2-2e3aa12b6d69.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium iodide,7681-82-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50562704-4829-4885-8883-483a301f6808/documents/65e7393a-bc93-432a-8f21-fe253faed9fa_7555e46d-b16b-44bd-a3b2-2e3aa12b6d69.html,,inhalation,discriminating conc.,"50,000 mg/m3",no adverse effect observed, Sodium 2-hydroxyethanesulphonate,1562-00-1,"Oral administration of Sodium 2-hydroxyethanesulphonate to Wistar rats at doses of 50, 200 and 1000 mg/kg/day for 91/92 days resulted in no deaths, no clinical signs during daily or weekly observations, no clinical signs during the functional observational battery, no test item-related differences in the mean fore-or hindlimb grip strength or mean locomotor activity, no toxicologically relevant ophthalmoscopic changes, no differences in the mean food consumption, no changes in hematology parameters at 200 mg/kg/day or at 50 mg/kg/day, and no changes in urinalysis parameters at 50 mg/kg/day. Although statistically significant differences were noted in the mean hindlimb grip strength values of males treated with 1000 mg/kg/day, these were considered to be secondary effects to the lower body weights. Test item-related findings were generally restricted to slightly lower mean absolute and relative body weights in males treated with 1000 mg/kg/day, light changes in the hematology parameters of the rats treated with 1000 mg/kg/day, increased spleen weights in rats at 1000 mg/kg/day, and macroscopical changes in the liver and spleen. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/716d2944-0e7a-42e5-ba09-b775ade66c3d/documents/IUC5-cadb4132-0b56-4841-9d98-2163f626bc05_4e8c3d6e-c938-4698-89ab-a2310a5419ba.html,,,,,, Sodium 2-hydroxyethanesulphonate,1562-00-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/716d2944-0e7a-42e5-ba09-b775ade66c3d/documents/IUC5-cadb4132-0b56-4841-9d98-2163f626bc05_4e8c3d6e-c938-4698-89ab-a2310a5419ba.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,, Sodium 2-hydroxyethanesulphonate,1562-00-1,"Acute toxicity after single oral application was tested in male and female rats, which received 5000 mg/kg bw. One female and no male died. The necropsy of the deceased female did not reveal any effect and the death was not found to be treatment-related. The LD50 value for acute oral toxicity is >5000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/716d2944-0e7a-42e5-ba09-b775ade66c3d/documents/IUC5-b5dd7b0c-6089-4b19-bcfd-d8381b7bf66b_4e8c3d6e-c938-4698-89ab-a2310a5419ba.html,,,,,, Sodium 2-hydroxyethanesulphonate,1562-00-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/716d2944-0e7a-42e5-ba09-b775ade66c3d/documents/IUC5-b5dd7b0c-6089-4b19-bcfd-d8381b7bf66b_4e8c3d6e-c938-4698-89ab-a2310a5419ba.html,,oral,LD50,"5,000 mg/kg bw",, Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl isooctadecanoate,66988-04-3," In several repeated dose oral toxicity studies on suitable read-across partners (fatty acid lactylates, sodium or calcium salts), no adverse effects were observed up to doses above the relevant limit dose of 1000 mg/kg bw/d. There are some indications of increased relative liver weights and retarded growth in rats fed calcium stearoyl lactylate, but these effects appear to be reversible when exposure ceased. Also, a one-year repeated dose toxicity study on sodium stearoyl lactylate reported no-observed-adverse-effect-levels (NOAELs) above 2000 mg/kg bw/day in both male and female rats. Taking this information altogether, sodium isostearoyl lactylate is not considered to be hazardous substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec57416a-6c21-4b12-9e93-d0e5e86113e2/documents/fe321c4d-8a81-4061-b412-ccab9960ccd3_c07f78d2-3ab3-4e8a-be78-858225a2880e.html,,,,,, Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl isooctadecanoate,66988-04-3," The oral LD50 of sodium isostearoyl lactylate (Pationic ISL) was determined to be greater than 6100 mg/kg bw in Sprague-Dawley rats. Therefore, sodium isostearoyl lactylate is not acutely toxic. Acute dermal toxicity testing is not necessary due to lack of oral toxicity. Finally, acute inhalation toxicity testing is not necessary due to lack of exposure potential (very low vapour pressure, viscous liquid with no potential for aerosol generation). In conclusion sodium isostearoyl lactylate is not acutely toxic via any route of administration. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec57416a-6c21-4b12-9e93-d0e5e86113e2/documents/ea1190ca-f02d-499e-9345-bc06bef27cbe_c07f78d2-3ab3-4e8a-be78-858225a2880e.html,,,,,, Sodium 2-(1-carboxylatoethoxy)-1-methyl-2-oxoethyl isooctadecanoate,66988-04-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec57416a-6c21-4b12-9e93-d0e5e86113e2/documents/ea1190ca-f02d-499e-9345-bc06bef27cbe_c07f78d2-3ab3-4e8a-be78-858225a2880e.html,,oral,LD50,"6,100 mg/kg bw",no adverse effect observed, Sodium lactate,72-17-3," No data on repeated dose toxicity are available for the target substance Sodium lactate itself. Thus, available data from the structurally related substances Calcium lactate and Sodium chloride were used to assess in a read-across approach the specific target organ toxicity of Sodium lactate. Based on the results, no classification for specific target organ toxicity is warranted in accordance with CLP Regulation 1272/2008. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de8146c2-6127-4bb2-be5f-7825de8f4b1b/documents/e659d233-0566-4acd-be98-f6a85544f0d5_0a05e9f3-fa44-49d2-afb0-6e05928a5d7f.html,,,,,, Sodium lactate,72-17-3," By way of read-across from lactic acid (constituting the toxicologically relevant moiety) and sodium chloride, Sodium lactate is evaluated to be acutely non-toxic via any of the standard routes of administration (oral, inhalation, dermal). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de8146c2-6127-4bb2-be5f-7825de8f4b1b/documents/29295154-0adf-4994-a745-dfd67aa742ff_0a05e9f3-fa44-49d2-afb0-6e05928a5d7f.html,,,,,, Sodium lactate,72-17-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de8146c2-6127-4bb2-be5f-7825de8f4b1b/documents/29295154-0adf-4994-a745-dfd67aa742ff_0a05e9f3-fa44-49d2-afb0-6e05928a5d7f.html,,oral,LD50,"3,543 mg/kg bw",adverse effect observed, Sodium lactate,72-17-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de8146c2-6127-4bb2-be5f-7825de8f4b1b/documents/29295154-0adf-4994-a745-dfd67aa742ff_0a05e9f3-fa44-49d2-afb0-6e05928a5d7f.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Sodium lactate,72-17-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de8146c2-6127-4bb2-be5f-7825de8f4b1b/documents/29295154-0adf-4994-a745-dfd67aa742ff_0a05e9f3-fa44-49d2-afb0-6e05928a5d7f.html,,inhalation,LC50,"> 7,940 mg/m3",adverse effect observed, Sodium (S)-lactate,867-56-1," No data on repeated dose toxicity are available for the target substance Sodium (S)-lactate itself. Thus, available data from the structurally related substances Calcium lactate and Sodium chloride were used to assess in a read-across approach the specific target organ toxicity of Sodium (S)-lactate. Based on the results, no classification for specific target organ toxicity is warranted in accordance with CLP Regulation 1272/2008. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3c81acc-45d0-41c0-a7d8-ea1df94a3d9f/documents/IUC5-abcffe03-c995-4c6b-b73e-9048beb703ca_ac02f22b-5c06-46c2-a3ef-d930effe5893.html,,,,,, Sodium (S)-lactate,867-56-1," By way of read-across from lactic acid (constituting the toxicologically relevant moiety) and Sodium chloride, Sodium (S)-lactate is evaluated to be acutely non-toxic via any of the standard routes of administration (oral, inhalation, dermal). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3c81acc-45d0-41c0-a7d8-ea1df94a3d9f/documents/IUC5-c5c8a3a2-ae5f-4322-bce2-9b59823adbc2_ac02f22b-5c06-46c2-a3ef-d930effe5893.html,,,,,, Sodium (S)-lactate,867-56-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3c81acc-45d0-41c0-a7d8-ea1df94a3d9f/documents/IUC5-c5c8a3a2-ae5f-4322-bce2-9b59823adbc2_ac02f22b-5c06-46c2-a3ef-d930effe5893.html,,oral,LD50,"3,543 mg/kg bw",adverse effect observed, Sodium (S)-lactate,867-56-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3c81acc-45d0-41c0-a7d8-ea1df94a3d9f/documents/IUC5-c5c8a3a2-ae5f-4322-bce2-9b59823adbc2_ac02f22b-5c06-46c2-a3ef-d930effe5893.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Sodium (S)-lactate,867-56-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3c81acc-45d0-41c0-a7d8-ea1df94a3d9f/documents/IUC5-c5c8a3a2-ae5f-4322-bce2-9b59823adbc2_ac02f22b-5c06-46c2-a3ef-d930effe5893.html,,inhalation,LC50,"> 7,940 mg/m3",adverse effect observed, Sodium 2-(2-dodecyloxyethoxy)ethyl sulphate,3088-31-1,"The substance sodium 2-(2-dodecyloxyethoxy) ethyl sulphate does not exhibit repeated dose toxicity by the oral ,inhalation and dermal route. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/77f8dcc4-43ba-4375-8d10-9b0402836200/documents/IUC5-83ea39d0-1637-4b3a-9de2-6f8a3ce2a559_78a337a5-52f3-4ab8-9dc3-02b11495f816.html,,,,,, Sodium 2-(2-dodecyloxyethoxy)ethyl sulphate,3088-31-1,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/77f8dcc4-43ba-4375-8d10-9b0402836200/documents/IUC5-83ea39d0-1637-4b3a-9de2-6f8a3ce2a559_78a337a5-52f3-4ab8-9dc3-02b11495f816.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,60 mg/kg bw/day,,rabbit Sodium 2-(2-dodecyloxyethoxy)ethyl sulphate,3088-31-1,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/77f8dcc4-43ba-4375-8d10-9b0402836200/documents/IUC5-83ea39d0-1637-4b3a-9de2-6f8a3ce2a559_78a337a5-52f3-4ab8-9dc3-02b11495f816.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,508 mg/kg bw/day,,rat Sodium 2-(2-dodecyloxyethoxy)ethyl sulphate,3088-31-1,"The substance sodium 2-(2-dodecyloxyethoxy) ethyl sulphate does not show acute toxicity effect by the oral,dermal and inhalation route within the dose levels mentioned in the respective end points. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77f8dcc4-43ba-4375-8d10-9b0402836200/documents/IUC5-1163ae1f-f8a3-4c57-938c-c68ce89e0b86_78a337a5-52f3-4ab8-9dc3-02b11495f816.html,,,,,, Sodium 2-(2-dodecyloxyethoxy)ethyl sulphate,3088-31-1,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77f8dcc4-43ba-4375-8d10-9b0402836200/documents/IUC5-1163ae1f-f8a3-4c57-938c-c68ce89e0b86_78a337a5-52f3-4ab8-9dc3-02b11495f816.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, Sodium 2-(2-dodecyloxyethoxy)ethyl sulphate,3088-31-1,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77f8dcc4-43ba-4375-8d10-9b0402836200/documents/IUC5-1163ae1f-f8a3-4c57-938c-c68ce89e0b86_78a337a5-52f3-4ab8-9dc3-02b11495f816.html,,dermal,LD50,"3,658.33 mg/kg bw",no adverse effect observed, Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate,14960-06-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c5c9e646-50ec-4246-aa54-92a8134d3e12/documents/IUC5-779d08ac-5b67-49a5-bf99-23036e6168b4_c2b34c3d-2409-4554-a811-c16cb87f8256.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,160 mg/kg bw/day,,rat Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate,14960-06-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5c9e646-50ec-4246-aa54-92a8134d3e12/documents/IUC5-4723adcd-760c-47e2-a685-78df4da6bd19_c2b34c3d-2409-4554-a811-c16cb87f8256.html,,oral,LD50,"3,130 mg/kg bw",no adverse effect observed, Sodium N-(2-carboxyethyl)-N-dodecyl-β-alaninate,14960-06-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5c9e646-50ec-4246-aa54-92a8134d3e12/documents/IUC5-4723adcd-760c-47e2-a685-78df4da6bd19_c2b34c3d-2409-4554-a811-c16cb87f8256.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Sodium hydrogen N-(1-oxododecyl)-L-glutamate,29923-31-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Although the study has some restrictions, it is considered to fulfill basic requirements of data reporting. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5b34779-4c1e-40d6-a0bf-f93adba8963d/documents/IUC5-cbea8023-6f8b-45c5-b41b-69b0192bf55a_9ee568b5-1266-4dfd-b47c-15258d6766f5.html,,,,,, Sodium hydrogen N-(1-oxododecyl)-L-glutamate,29923-31-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5b34779-4c1e-40d6-a0bf-f93adba8963d/documents/IUC5-cbea8023-6f8b-45c5-b41b-69b0192bf55a_9ee568b5-1266-4dfd-b47c-15258d6766f5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat Sodium hydrogen N-(1-oxododecyl)-L-glutamate,29923-31-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 2 study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch 2 study ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5b34779-4c1e-40d6-a0bf-f93adba8963d/documents/IUC5-1981524b-2304-4375-b8ed-d19d3d322381_9ee568b5-1266-4dfd-b47c-15258d6766f5.html,,,,,, Sodium hydrogen N-(1-oxododecyl)-L-glutamate,29923-31-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5b34779-4c1e-40d6-a0bf-f93adba8963d/documents/IUC5-1981524b-2304-4375-b8ed-d19d3d322381_9ee568b5-1266-4dfd-b47c-15258d6766f5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium hydrogen N-(1-oxododecyl)-L-glutamate,29923-31-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5b34779-4c1e-40d6-a0bf-f93adba8963d/documents/IUC5-1981524b-2304-4375-b8ed-d19d3d322381_9ee568b5-1266-4dfd-b47c-15258d6766f5.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium N-lauroylsarcosinate,137-16-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises adequate and reliable subchronic and chronic studies performed with Sodium N-lauroylsarcosinate (CAS 137-16-6) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c234c2c2-0e0f-4d8e-a408-bc4149061202/documents/5091830f-82a5-465b-8e4f-2463339ee38c_a5b9108b-2abb-4d35-aacd-a6f57a8b6035.html,,,,,, Sodium N-lauroylsarcosinate,137-16-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c234c2c2-0e0f-4d8e-a408-bc4149061202/documents/5091830f-82a5-465b-8e4f-2463339ee38c_a5b9108b-2abb-4d35-aacd-a6f57a8b6035.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium N-lauroylsarcosinate,137-16-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study performed with Sodium N-lauroylsarcosinate (CAS 137-16-6). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The available information comprises an adequate and reliable study performed with Sodium N-lauroylsarcosinate (CAS 137-16-6). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c234c2c2-0e0f-4d8e-a408-bc4149061202/documents/46e33d93-039f-4b70-8df8-71c74d96bbd4_a5b9108b-2abb-4d35-aacd-a6f57a8b6035.html,,,,,, Sodium N-lauroylsarcosinate,137-16-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c234c2c2-0e0f-4d8e-a408-bc4149061202/documents/46e33d93-039f-4b70-8df8-71c74d96bbd4_a5b9108b-2abb-4d35-aacd-a6f57a8b6035.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium N-lauroylsarcosinate,137-16-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c234c2c2-0e0f-4d8e-a408-bc4149061202/documents/46e33d93-039f-4b70-8df8-71c74d96bbd4_a5b9108b-2abb-4d35-aacd-a6f57a8b6035.html,,inhalation,LC50,50 mg/m3,adverse effect observed, Sodium 2-[(1-oxododecyl)amino]ethanesulphonate,70609-66-4," LD50 was estimated to be 4940mg/kg bw, when male and female rats were exposed with sodium 2-[(1-oxododecyl) amino]ethanesulphonate (70609-66-4) orally. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c18b2021-20d5-4dbb-9e57-0a5e28c70049/documents/b65388a7-4836-4d37-a357-7170e5c5d3e2_5855d8ec-7337-4cbf-a598-2400c53b1e80.html,,,,,, Sodium 2-[(1-oxododecyl)amino]ethanesulphonate,70609-66-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c18b2021-20d5-4dbb-9e57-0a5e28c70049/documents/b65388a7-4836-4d37-a357-7170e5c5d3e2_5855d8ec-7337-4cbf-a598-2400c53b1e80.html,,oral,LD50,"4,940 mg/kg bw",no adverse effect observed, Sodium dodecyl sulphate,151-21-3,For the whole category of alkyl sulfates (AS) a NOAEL of 488 mg/kg bw/day for oral and dermal exposure was established. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a01686b6-914a-4c33-93f1-20a249d97928/documents/ca0dd5a0-b0e7-480c-90ad-c3ec12ab38f0_096670eb-8a26-406a-b1ad-1155564c11e4.html,,,,,, Sodium dodecyl sulphate,151-21-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a01686b6-914a-4c33-93f1-20a249d97928/documents/ca0dd5a0-b0e7-480c-90ad-c3ec12ab38f0_096670eb-8a26-406a-b1ad-1155564c11e4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,488 mg/kg bw/day,,rat Sodium dodecyl sulphate,151-21-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a01686b6-914a-4c33-93f1-20a249d97928/documents/ca0dd5a0-b0e7-480c-90ad-c3ec12ab38f0_096670eb-8a26-406a-b1ad-1155564c11e4.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,,mouse Sodium dodecyl sulphate,151-21-3,"Oral LD50 (OECD guideline 401), rat = 1200 mg/kg bwDermal LD50 (OECD guideline 402), rabbit >= 2000 mg/kg bw (limit test)Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a01686b6-914a-4c33-93f1-20a249d97928/documents/c6b520db-4e4d-49a5-9135-feb0edbf2575_096670eb-8a26-406a-b1ad-1155564c11e4.html,,,,,, Sodium dodecyl sulphate,151-21-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a01686b6-914a-4c33-93f1-20a249d97928/documents/c6b520db-4e4d-49a5-9135-feb0edbf2575_096670eb-8a26-406a-b1ad-1155564c11e4.html,,oral,LD50,"1,200 mg/kg bw",adverse effect observed, Sodium dodecyl sulphate,151-21-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a01686b6-914a-4c33-93f1-20a249d97928/documents/c6b520db-4e4d-49a5-9135-feb0edbf2575_096670eb-8a26-406a-b1ad-1155564c11e4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sulfuric acid, mono-C12-16-alkyl esters, sodium salts",73296-89-6,For the whole category of alkyl sulfates (AS) a NOAEL of 488 mg/kg bw/day for oral and dermal exposure was established. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5da04314-b386-4e24-acfd-954ddc301016/documents/IUC5-6deea39c-8e9c-415c-a685-c6da921e3c48_3ec49f10-e784-44fd-b4ab-461ddaeaddcc.html,,,,,, "Sulfuric acid, mono-C12-16-alkyl esters, sodium salts",73296-89-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5da04314-b386-4e24-acfd-954ddc301016/documents/IUC5-6deea39c-8e9c-415c-a685-c6da921e3c48_3ec49f10-e784-44fd-b4ab-461ddaeaddcc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,488 mg/kg bw/day,,rat "Sulfuric acid, mono-C12-16-alkyl esters, sodium salts",73296-89-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5da04314-b386-4e24-acfd-954ddc301016/documents/IUC5-6deea39c-8e9c-415c-a685-c6da921e3c48_3ec49f10-e784-44fd-b4ab-461ddaeaddcc.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,,mouse "Sulfuric acid, mono-C12-16-alkyl esters, sodium salts",73296-89-6,"Oral LD50 (OECD guideline 401), rat = 2600 mg/kg bwDermal LD50 (OECD guideline 402), rabbit > 2000 mg/kg bw (limit test) Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5da04314-b386-4e24-acfd-954ddc301016/documents/IUC5-c979b60d-e59b-427e-90b6-62a2ec706993_3ec49f10-e784-44fd-b4ab-461ddaeaddcc.html,,,,,, "Sulfuric acid, mono-C12-16-alkyl esters, sodium salts",73296-89-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5da04314-b386-4e24-acfd-954ddc301016/documents/IUC5-c979b60d-e59b-427e-90b6-62a2ec706993_3ec49f10-e784-44fd-b4ab-461ddaeaddcc.html,,oral,LD50,"2,600 mg/kg bw",adverse effect observed, "Sulfuric acid, mono-C12-16-alkyl esters, sodium salts",73296-89-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5da04314-b386-4e24-acfd-954ddc301016/documents/IUC5-c979b60d-e59b-427e-90b6-62a2ec706993_3ec49f10-e784-44fd-b4ab-461ddaeaddcc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sulfuric acid, mono-C12-14-alkyl esters, sodium salts",85586-07-8,For the whole category of alkyl sulfates (AS) a NOAEL of 488 mg/kg bw/day for oral and dermal exposure was established. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c426c9c7-1827-4e26-b68c-1dbfee23726b/documents/IUC5-ebdaae11-6fa0-4a77-a23d-32aa7c3ed466_07230d26-13c3-48f9-9ec8-8dd517a8880c.html,,,,,, "Sulfuric acid, mono-C12-14-alkyl esters, sodium salts",85586-07-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c426c9c7-1827-4e26-b68c-1dbfee23726b/documents/IUC5-ebdaae11-6fa0-4a77-a23d-32aa7c3ed466_07230d26-13c3-48f9-9ec8-8dd517a8880c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,488 mg/kg bw/day,,rat "Sulfuric acid, mono-C12-14-alkyl esters, sodium salts",85586-07-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c426c9c7-1827-4e26-b68c-1dbfee23726b/documents/IUC5-ebdaae11-6fa0-4a77-a23d-32aa7c3ed466_07230d26-13c3-48f9-9ec8-8dd517a8880c.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,,mouse "Sulfuric acid, mono-C12-14-alkyl esters, sodium salts",85586-07-8,"Oral LD50 (OECD guideline 401), rat = 1800 mg/kg bwDermal LD50 (OECD guideline 402), rabbit > 2000 mg/kg bw (limit test) Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c426c9c7-1827-4e26-b68c-1dbfee23726b/documents/IUC5-6a06630f-e9b8-49b6-aad7-1c43a446eded_07230d26-13c3-48f9-9ec8-8dd517a8880c.html,,,,,, "Sulfuric acid, mono-C12-14-alkyl esters, sodium salts",85586-07-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c426c9c7-1827-4e26-b68c-1dbfee23726b/documents/IUC5-6a06630f-e9b8-49b6-aad7-1c43a446eded_07230d26-13c3-48f9-9ec8-8dd517a8880c.html,,oral,LD50,"1,800 mg/kg bw",adverse effect observed, "Sulfuric acid, mono-C12-14-alkyl esters, sodium salts",85586-07-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c426c9c7-1827-4e26-b68c-1dbfee23726b/documents/IUC5-6a06630f-e9b8-49b6-aad7-1c43a446eded_07230d26-13c3-48f9-9ec8-8dd517a8880c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 4-oxovalerate,19856-23-6,"No adverse treatment-related response that results in change in morphology, physiology or growth  of an animal organism was recorded. The NOAEL (No Observed Adverse Effect Level) value for REPEATED DOSE TOXICITY (90 days) in male and female rats for the test item acid was established as 1 000 mg/kg body weight/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ecfcc0d9-cadc-47ac-bdd7-91ea060b738c/documents/ce6d6571-ed5d-4049-816d-64a6cf744b80_fbaae294-7141-4775-a163-5ac92e0bf5b3.html,,,,,, Sodium 4-oxovalerate,19856-23-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ecfcc0d9-cadc-47ac-bdd7-91ea060b738c/documents/ce6d6571-ed5d-4049-816d-64a6cf744b80_fbaae294-7141-4775-a163-5ac92e0bf5b3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium 4-oxovalerate,19856-23-6," 300 mg/kg < LD50 (rat, oral) < 2000 mg/kg LD50 (rat, dermal) > 2000 mg/kg ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecfcc0d9-cadc-47ac-bdd7-91ea060b738c/documents/f8f8eb05-9ea6-44e2-b1ef-718f69df3647_fbaae294-7141-4775-a163-5ac92e0bf5b3.html,,,,,, Sodium 4-oxovalerate,19856-23-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecfcc0d9-cadc-47ac-bdd7-91ea060b738c/documents/f8f8eb05-9ea6-44e2-b1ef-718f69df3647_fbaae294-7141-4775-a163-5ac92e0bf5b3.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Sodium 4-oxovalerate,19856-23-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecfcc0d9-cadc-47ac-bdd7-91ea060b738c/documents/f8f8eb05-9ea6-44e2-b1ef-718f69df3647_fbaae294-7141-4775-a163-5ac92e0bf5b3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 3-nitrobenzenesulphonate,127-68-4," Repeated dose toxicity: Oral Based on all the test results from the repeated dose 90 day oral toxicity study, it was concluded that there were no test chemical related adverse effects observed on any of the parameters including reproductive parameters such as estrous cycle, hormonal analysis, sperm evaluation and also reproductive organs (testes, ovaries, uterus, epididymides, Seminal vesicles & coagulating glands) at the highest tested dose i.e. 1000 mg/kg bw. Thus, the test chemical is not likely to classify in category STOT-RE 1/2 as per the CLP criteria of classification and labelling. Repeated dose toxicity: Inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance sodium 3-nitrobenzenesulfonate (127-68-4), which is reported as 0.07725636 mm Hg at 25 C. Also considering the particle size distribution of the substance the majority of the particles was found to be in the size of 150 micron to 75 micron which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical sodium 3-nitrobenzenesulfonate is highly unlikely. Therefore this end point for repeated dose exposure by inhalation route is considered for waiver. Repeated dose toxicity: Dermal The acute toxicity value for sodium 3-nitrobenzenesulfonate (127-68-4)  (as provided in section 7.2.3) is 2794 mg/kg body weight.  As well as Repeated dermal toxicity is unlikely to occur since dermal absorption of substance sodium 3-nitrobenzenesulphonate is very low based on the value 0.005 mg/cm2/event. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75a5611f-288b-4d06-a5e6-f31610681554/documents/IUC5-6c2242a9-1126-4433-873c-14713e72173a_466ff90d-7c5c-4ac0-bbd2-fdb2af31363d.html,,,,,, Sodium 3-nitrobenzenesulphonate,127-68-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75a5611f-288b-4d06-a5e6-f31610681554/documents/IUC5-6c2242a9-1126-4433-873c-14713e72173a_466ff90d-7c5c-4ac0-bbd2-fdb2af31363d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium 3-nitrobenzenesulphonate,127-68-4," Acute oral toxicity:  Acute oral toxicity dose (LD50) of test chemical was considered based on the different experimental studies conductred on rats, All these studies concluded that the LD50 is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the test chemical cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  Acute Inhalation toxicity dose (LC50) for test chemical was considered based experimental study conducted on rat is >5.1 mg/L (>5100 mg/m3). Thus, comparing this value with the criteria of CLP regulation, the test chemical cannot be classified for acute Inhalation toxicity. Acute Dermal toxicity:  The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75a5611f-288b-4d06-a5e6-f31610681554/documents/IUC5-ec3ca6bb-102b-46f5-a796-5e1719be1e5a_466ff90d-7c5c-4ac0-bbd2-fdb2af31363d.html,,,,,, Sodium 3-nitrobenzenesulphonate,127-68-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75a5611f-288b-4d06-a5e6-f31610681554/documents/IUC5-ec3ca6bb-102b-46f5-a796-5e1719be1e5a_466ff90d-7c5c-4ac0-bbd2-fdb2af31363d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium 3-nitrobenzenesulphonate,127-68-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75a5611f-288b-4d06-a5e6-f31610681554/documents/IUC5-ec3ca6bb-102b-46f5-a796-5e1719be1e5a_466ff90d-7c5c-4ac0-bbd2-fdb2af31363d.html,,dermal,LD50,"2,794 mg/kg bw",no adverse effect observed, Sodium 3-nitrobenzenesulphonate,127-68-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75a5611f-288b-4d06-a5e6-f31610681554/documents/IUC5-ec3ca6bb-102b-46f5-a796-5e1719be1e5a_466ff90d-7c5c-4ac0-bbd2-fdb2af31363d.html,,inhalation,LC50,"5,100 mg/m3",no adverse effect observed, "Silicic acid, aluminum magnesium sodium salt",12040-43-6,"Oral No oral repeated dose toxicity studies available. Inhalation is the most appropriate route of administration.   Dermal No dermal repeated dose toxicity studies.   Inhalation: LOAEL (local): 1 mg/m³ (effective) LOAEL (local): 3.23 mg/m³ (nominal) No local NOAEL identified.   NOAEL (systemic): > 5 mg/m³ (effective) NOAEL (systemic): > 16.13 mg/m³ (nominal)   Creutzenberg, 2014, OECD 413: The target aerosol concentrations of 1, 2.5 and 5 mg NM-200/m³ were achieved to 104%, 100% and 101%, respectively. Calculation of the aerosol generation efficiency (actual vs. nominal concentration) resulted in 31%; this low value demonstrates that experimental conditions are different to any handling and use conditions of NM-200.  - Due to the particle size distribution in the test medium the nominal concentration was 3.23 mg/m³, to achieve 1 mg/m³ aerosol test concentration.  - Due to the particle size distribution in the test medium the nominal concentration was 8.06 mg/m³, to achieve 2.5 mg/m³ aerosol test concentration.  - Due to the particle size distribution in the test medium the nominal concentration was 16.13 mg/m³, to achieve 5 mg/m³ aerosol test concentration.   This results in a NOAEL > 5 mg/m³ air corresponding to > 16.13 mg/m³ nominal concentration in air for NM-200 which is taken as a worst-case approach for SMAS. Worst case is justified based on the nine-times higher solubility of the SMAS in comparison to test item NM-200 (SAS). This suggests that a NOAEL for SMAS will be much higher (200 mg/m³).  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): RL2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): RL1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7059c05d-2d0b-4062-b0fc-63828d6fbf8d/documents/5cdde926-cef0-4676-b163-97f66a5d6130_e76887bd-c8bc-4e2f-aa6d-3e9fb11d60ed.html,,,,,, "Silicic acid, aluminum magnesium sodium salt",12040-43-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7059c05d-2d0b-4062-b0fc-63828d6fbf8d/documents/5cdde926-cef0-4676-b163-97f66a5d6130_e76887bd-c8bc-4e2f-aa6d-3e9fb11d60ed.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,16.13 mg/m3,,rat "Silicic acid, aluminum magnesium sodium salt",12040-43-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7059c05d-2d0b-4062-b0fc-63828d6fbf8d/documents/5cdde926-cef0-4676-b163-97f66a5d6130_e76887bd-c8bc-4e2f-aa6d-3e9fb11d60ed.html,Repeated dose toxicity – local effects,inhalation,LOAEC,3.23 mg/m3,adverse effect observed,rat "Silicic acid, aluminum magnesium sodium salt",12040-43-6," Oral: Silicic acid, aluminium magnesium sodium salt LD50: > 2000 mg/kg bw for rats (Key, Colas, 2009, OECD 423, SMAS, RL1) In accordance with the OECD guideline 423, the LD50 cut-off of the test item may be considered higher than 5000 mg/kg bw by oral route in the rat. Inhalation: Silicic acid, aluminium magnesium sodium salt In accordance with the OECD guideline 403, the LC50 of the test item is higher than 5.221 mg/l aerosol concentration by inhalation route in the rat . (Key, Stahl, 2012, sim. OECD 403, SMAS, RL1) Dermal: Silicic acid, aluminium magnesium sodium salt LD50: > 2000 mg/kg bw for wistar rats (Key, Hozova, 2016, OECD 402, SMAS, RL1) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7059c05d-2d0b-4062-b0fc-63828d6fbf8d/documents/9d76cb96-b1eb-4bdc-9bdc-055bf4a1a2d1_e76887bd-c8bc-4e2f-aa6d-3e9fb11d60ed.html,,,,,, "Silicic acid, aluminum magnesium sodium salt",12040-43-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7059c05d-2d0b-4062-b0fc-63828d6fbf8d/documents/9d76cb96-b1eb-4bdc-9bdc-055bf4a1a2d1_e76887bd-c8bc-4e2f-aa6d-3e9fb11d60ed.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Silicic acid, aluminum magnesium sodium salt",12040-43-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7059c05d-2d0b-4062-b0fc-63828d6fbf8d/documents/9d76cb96-b1eb-4bdc-9bdc-055bf4a1a2d1_e76887bd-c8bc-4e2f-aa6d-3e9fb11d60ed.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Silicic acid, aluminum magnesium sodium salt",12040-43-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7059c05d-2d0b-4062-b0fc-63828d6fbf8d/documents/9d76cb96-b1eb-4bdc-9bdc-055bf4a1a2d1_e76887bd-c8bc-4e2f-aa6d-3e9fb11d60ed.html,,inhalation,LC50,"5,221 mg/m3",no adverse effect observed, Disodium disulphite,7681-57-4,"A 3-generation chronic toxicity study (Til et al. 1972a) with treatment of rats (20 per sex and group) with dose levels of 0, 0.125, 0.25, 0.5, 1.0 or 2.0% Na2S2O5 administered in a 50 ppm thiamine-containing diet was identified as most reliable study for repeated dose toxicity and was defined as key study. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55b88ef3-7216-4d3f-b2de-56f8a1772a48/documents/IUC5-1cfb38b4-a26e-4d4a-bb5c-ef48089c7064_2898479d-827c-4b1a-b6d6-075a576508a5.html,,,,,, Disodium disulphite,7681-57-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55b88ef3-7216-4d3f-b2de-56f8a1772a48/documents/IUC5-1cfb38b4-a26e-4d4a-bb5c-ef48089c7064_2898479d-827c-4b1a-b6d6-075a576508a5.html,Chronic toxicity – systemic effects,oral,NOAEL,108 mg/kg bw/day,,rat Disodium disulphite,7681-57-4,"Based on the described read-across methodology information from sodium sulfite (CAS 7757-83-7) and potassium metabisulfite (CAS 16731 -55 -8) as well as substance specific information for sodium metabisulfite (CAS 7681 -57 -4) were used to determine acute toxicity values (oral, dermal and inhalative) for sodium metabisulfite. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55b88ef3-7216-4d3f-b2de-56f8a1772a48/documents/IUC5-15d10267-af59-4828-af86-f5c8305927dc_2898479d-827c-4b1a-b6d6-075a576508a5.html,,,,,, Disodium metasilicate,6834-92-0,NOAEL (rats): 227 mg/kg bw/dayNOAEL (mice): 260 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5912d934-4cf7-40e3-93dc-a2ffefb12ca3/documents/60ba16e1-f8d9-4e07-a7c9-3d46fd206f2f_9989a275-b442-4d6c-ae98-d21583073bae.html,,,,,, Disodium metasilicate,6834-92-0,oral: LD50 (rat) = 1152 - 1349 mg/kg bwinhalation: LC50 (rat) > 2.06 g/m3dermal: LD50 (rat) > 5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5912d934-4cf7-40e3-93dc-a2ffefb12ca3/documents/348f2b9c-7e55-454e-a80d-911afc454900_9989a275-b442-4d6c-ae98-d21583073bae.html,,,,,, "Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts",61791-42-2," Oral repeated dose toxicity (OECD 422 and OECD 408), rat (m/f): NOAEL systemic = 300 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77c9fa8e-dc27-4c3c-b11a-8c8359ac8648/documents/eed97c8a-ffb3-4b23-9ac5-e19b1f5f1295_48a2fa16-7511-4dcc-9ed5-a9411972dc76.html,,,,,, "Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts",61791-42-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77c9fa8e-dc27-4c3c-b11a-8c8359ac8648/documents/eed97c8a-ffb3-4b23-9ac5-e19b1f5f1295_48a2fa16-7511-4dcc-9ed5-a9411972dc76.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts",61791-42-2," Oral (OECD 401), rat: LD50 > 2000 mg/kg bw Data from registered substance and read-across from structural source substance sodium 2-[methyloleoylamino]ethane-1-sulphonate(CAS 137-20-2). Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw Read-across from structural source substance sodium 2-[methyloleoylamino]ethane-1-sulphonate (CAS 137-20-2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77c9fa8e-dc27-4c3c-b11a-8c8359ac8648/documents/3ab8d17e-6d85-4b87-b617-6076c021d8d7_48a2fa16-7511-4dcc-9ed5-a9411972dc76.html,,,,,, "Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts",61791-42-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77c9fa8e-dc27-4c3c-b11a-8c8359ac8648/documents/3ab8d17e-6d85-4b87-b617-6076c021d8d7_48a2fa16-7511-4dcc-9ed5-a9411972dc76.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Ethanesulfonic acid, 2-(methylamino)-, N-coco acyl derivs., sodium salts",61791-42-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77c9fa8e-dc27-4c3c-b11a-8c8359ac8648/documents/3ab8d17e-6d85-4b87-b617-6076c021d8d7_48a2fa16-7511-4dcc-9ed5-a9411972dc76.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Sodium 2-[methyl(1-oxododecyl)amino]ethanesulphonate,4337-75-1," The daily oral (dietary) administration of the read-across source substance sodium methyl cocoyl taurate (SMCT) to rats (Sprague Dawley strain, bred at Harlan UK Ltd.) did not produce any toxicological changes considered to be related to treatment. The no-effect level was greater than 1.0% of SMCT in the diet, equivalent to 500 mg/kg bw/d. This study for the source substance SMCT is used as read-across to the registered (target) substance SMLT. See section 13 for the full read-across justification. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5655e4e-df6d-4188-b9e9-35c58501a87d/documents/5c127e1a-8da9-4e08-baac-096ef1af2d28_487cf4fe-bb3d-4d24-b687-e4b8b030f2d5.html,,,,,, Sodium 2-[methyl(1-oxododecyl)amino]ethanesulphonate,4337-75-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5655e4e-df6d-4188-b9e9-35c58501a87d/documents/5c127e1a-8da9-4e08-baac-096ef1af2d28_487cf4fe-bb3d-4d24-b687-e4b8b030f2d5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Sodium 2-[methyl(1-oxododecyl)amino]ethanesulphonate,4337-75-1,"With regard to the endpoint acute systemic toxicity, test data for the oral route on the read-across analogue source substance SMCT is available. Based on an OECD 401 acute oral toxicity study, the limit dose of 2000 mg/kg body weight revealed no mortality and no clinical signs of intoxication. Macroscopic findings during gross pathology were not observed. Based on the findings the LD 50 was established to be greater than 2000 mg/kg body weight. Hence, based on read-across, the acute oral toxicity of the registered/target substance SMLT is considered to be greater 2000 mg/kg body weight. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5655e4e-df6d-4188-b9e9-35c58501a87d/documents/f3c9c02c-e7a0-4bdf-b6f7-0b15219a5d28_487cf4fe-bb3d-4d24-b687-e4b8b030f2d5.html,,,,,, Sodium 2-[methyl(1-oxododecyl)amino]ethanesulphonate,4337-75-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5655e4e-df6d-4188-b9e9-35c58501a87d/documents/f3c9c02c-e7a0-4bdf-b6f7-0b15219a5d28_487cf4fe-bb3d-4d24-b687-e4b8b030f2d5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 4-(methoxycarbonyl)phenolate,5026-62-0,"NOAEL (OECD 408), rat, oral: 1000 mg/kg bw/d (read-across from methyl paraben CAS-No. 99-76-3) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/effc9035-e0ba-4c46-aeb6-7660fd92ea62/documents/IUC5-d21ca850-259a-4f82-b7a1-c368b4dcab2e_ee02211b-edf6-489d-bddf-bbbf5d299bf6.html,,,,,, Sodium 4-(methoxycarbonyl)phenolate,5026-62-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/effc9035-e0ba-4c46-aeb6-7660fd92ea62/documents/IUC5-d21ca850-259a-4f82-b7a1-c368b4dcab2e_ee02211b-edf6-489d-bddf-bbbf5d299bf6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium 4-(methoxycarbonyl)phenolate,5026-62-0,"Oral (OECD 401), rat: LD50 > 5000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/effc9035-e0ba-4c46-aeb6-7660fd92ea62/documents/IUC5-cdc8b16e-1886-48cd-a359-f55a402a3470_ee02211b-edf6-489d-bddf-bbbf5d299bf6.html,,,,,, Sodium 4-(methoxycarbonyl)phenolate,5026-62-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/effc9035-e0ba-4c46-aeb6-7660fd92ea62/documents/IUC5-cdc8b16e-1886-48cd-a359-f55a402a3470_ee02211b-edf6-489d-bddf-bbbf5d299bf6.html,,oral,LD50,"5,000 mg/kg bw",adverse effect observed, Sodium N-methyltaurinate,4316-74-9," The guideline study on acute oral toxicity of sodium N-methyltaurinate was conducted according to OECD 401 using Sprague-Dawley rats. LD0 and NOAEL of sodium N-methyltaurinate are >= 2500 mg/kg bw. The test animals did not show any signs of intolerance reactions and no pathological signs have been found from the autopsies. This result is supported by another provided OECD 401 guideline study, which reports the acute oral toxicity of sodium N-methyltaurinate on Wistar rats. The tested LD50 in this study is >= 4670 mg/kg bw. These findings reflect the low toxicity of sodium N-methyltaurinate. In conclusion, the substance does not need to be classified for oral toxicity according to GHS criteria. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca0382b8-80ee-4bf2-bb05-842603b93520/documents/IUC5-507b5b46-2e0c-4f6c-ad0e-1cacad3bf8d1_7fec5142-e7b3-46af-be5e-9a062b29d902.html,,,,,, Sodium N-methyltaurinate,4316-74-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca0382b8-80ee-4bf2-bb05-842603b93520/documents/IUC5-507b5b46-2e0c-4f6c-ad0e-1cacad3bf8d1_7fec5142-e7b3-46af-be5e-9a062b29d902.html,,oral,,"2,500 mg/kg bw",no adverse effect observed, Disodium molybdate,7631-95-0," NOAEL for systemic toxicity, oral, from a sub-chronic study in rats: 17 mg Mo/kg bw/day. NOAEC for systemic toxicity, inhalation, from a sub-chronic study in rats and mice: 66.7 mg Mo/m³. Important: both values based on element Mo, not on a specific substance! ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c231a125-cc56-4688-913c-9a9bc644a3f2/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_49b2d41a-b493-4140-9283-1c814a9bf6eb.html,,,,,, Disodium molybdate,7631-95-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c231a125-cc56-4688-913c-9a9bc644a3f2/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_49b2d41a-b493-4140-9283-1c814a9bf6eb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat Disodium molybdate,7631-95-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c231a125-cc56-4688-913c-9a9bc644a3f2/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_49b2d41a-b493-4140-9283-1c814a9bf6eb.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,66.7 mg/m3,,"other:rat, mice" Disodium molybdate,7631-95-0," To avoid unnecessary (animal) testing, a comprehensive grouping and read-across concept has been developed amongst several molybdenum containing substances. Acute oral, inhalation and dermal toxicity studies are available for several but not all substances in the category. The following LD50s are therefore either based on test data for the substance in this dossier, or based on read-across within the category: For sodium molybdate (dihydrate): LD50oral = 4040 mg/kg bw (males); 4461 mg/kg bw (females) (based on study with this substance) LD50dermal > 2000 mg/kg bw (limit test) (based on study with this substance) LC50inhalation, 4h > 1.93 g/m³ (maximum attainable concentration) (based on study with this substance) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c231a125-cc56-4688-913c-9a9bc644a3f2/documents/IUC5-2f0856fd-75ea-4be2-914c-44ade348812b_49b2d41a-b493-4140-9283-1c814a9bf6eb.html,,,,,, Disodium fluorophosphate,10163-15-2,"A repeated dose toxicity study with reproduction/developmental toxicity screening test in the rat (OECD Method 422) via the oral route (gavage) has been performed at Harlan Laboratories Ltd. Alongside a 2 year carcinogenicity study of sodium fluoride, the data are sufficient to provide a qualitative understanding of the toxicological properties of disodium fluorophosphate without the need for further toxicity testing. No NOAEL was identified in the study, but the results were sufficient to accurately describe the effects of disodium fluorophosphate as relating to the fluoride content. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ad47c41-3d77-4d53-b4ec-041bb2607885/documents/IUC5-841e0b95-d20e-493c-b4fa-de83e10ca3d7_1d2bc721-77c0-400f-a682-23f689fb9396.html,,,,,, Disodium fluorophosphate,10163-15-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ad47c41-3d77-4d53-b4ec-041bb2607885/documents/IUC5-841e0b95-d20e-493c-b4fa-de83e10ca3d7_1d2bc721-77c0-400f-a682-23f689fb9396.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,30 mg/kg bw/day,,rat Disodium fluorophosphate,10163-15-2,"Acute oral toxicity: Three weight of evidence studies are available for the acute oral toxicity endpoint, all studies are conducted prior to the institution of GLP but are well documented and acceptable for assessment. The studies, Lim (1978) and Shourie (1950) report LD50 values of 710 mg/kg bw and 570 ± 68 mg/ kg bw respectively.The third, Whitford (1990) reports higher values but in the same classification range. According to Regulation (EC) No 1272/2008 (EU CLP) these results are sufficient to classify the test material for acute toxicity via the oral route (Category 4).Acute dermal toxicity: Testing was waived on the basis that further in vivo testing is considered to be scientifically unjustified as testing has been performed on the likely route of exposure (inhalation).Acute inhalation toxicity: A GLP study conducted according to OECD Guideline 403 is available to assess the acute inhalation toxicity of disodium fluorophosphate. The acute inhalation median lethal concentration (LC50) of the test material was found to be greater than the maximum attainable concentration and the study is therefore considered to be equivalent to a limit test conducted at 5mg/ L. In accordance with Regulation EC (No.) 1272/2008 (EU CLP) disodium fluorophosphate will not be classified for acute inhalation toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ad47c41-3d77-4d53-b4ec-041bb2607885/documents/IUC5-b2dc5ba0-a7bd-4364-ba8b-3accaba6dfa6_1d2bc721-77c0-400f-a682-23f689fb9396.html,,,,,, Disodium fluorophosphate,10163-15-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ad47c41-3d77-4d53-b4ec-041bb2607885/documents/IUC5-b2dc5ba0-a7bd-4364-ba8b-3accaba6dfa6_1d2bc721-77c0-400f-a682-23f689fb9396.html,,oral,LD50,570 mg/kg bw,adverse effect observed, Disodium fluorophosphate,10163-15-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ad47c41-3d77-4d53-b4ec-041bb2607885/documents/IUC5-b2dc5ba0-a7bd-4364-ba8b-3accaba6dfa6_1d2bc721-77c0-400f-a682-23f689fb9396.html,,inhalation,LC50,"2,100 mg/m3",no adverse effect observed, Sodium hydrogen N-(1-oxotetradecyl)-L-glutamate,38517-37-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f24901f9-639c-431f-86ec-34a027af7e06/documents/f0418f23-ab6f-4851-b644-c900968f70e2_38a1b65d-22d4-4d04-ac58-2ce5729387a4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat Sodium hydrogen N-(1-oxotetradecyl)-L-glutamate,38517-37-2,Acute toxicity  ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f24901f9-639c-431f-86ec-34a027af7e06/documents/da6aea3d-b103-4543-8af5-d5d66663f4bc_38a1b65d-22d4-4d04-ac58-2ce5729387a4.html,,,,,, Sodium hydrogen N-(1-oxotetradecyl)-L-glutamate,38517-37-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f24901f9-639c-431f-86ec-34a027af7e06/documents/da6aea3d-b103-4543-8af5-d5d66663f4bc_38a1b65d-22d4-4d04-ac58-2ce5729387a4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium hydrogen N-(1-oxotetradecyl)-L-glutamate,38517-37-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f24901f9-639c-431f-86ec-34a027af7e06/documents/da6aea3d-b103-4543-8af5-d5d66663f4bc_38a1b65d-22d4-4d04-ac58-2ce5729387a4.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate,30364-51-3," Repeated dose toxicity - oral (no OECD, 2-year study), rat: NOAEL ≥ 1000 mg/kg bw/day Repeated dose toxicity - oral (OECD 408, 90-day), rat: NOAEL ≥ 250 mg/kg bw/day RA from source substance Sodium N-lauroylsarcosinate (CAS 137-16-6) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09cd4c8d-8f16-440d-91c1-0acf54575f22/documents/67def407-4fd7-4c36-ab27-df378dd85769_58164a8f-22d9-49a1-b53c-b06953fbd48e.html,,,,,, Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate,30364-51-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09cd4c8d-8f16-440d-91c1-0acf54575f22/documents/67def407-4fd7-4c36-ab27-df378dd85769_58164a8f-22d9-49a1-b53c-b06953fbd48e.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate,30364-51-3," Oral: (WoE, OECD 401), rat: LD50 > 5000 mg/kg bw RA from Sodium N-lauroylsarcosinate (CAS 137-16-6) and N-methyl-N-[C18-(unsaturated)alkanoyl]glycine (EC 701-177-3) Inhalation: Data waiving as studies for two other routes, i.e. oral and dermal, are provided. Dermal (OECD 402), rat (m/f): LD50 > 2000 mg/kg bw (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09cd4c8d-8f16-440d-91c1-0acf54575f22/documents/IUC5-8402eeb7-8973-4147-943d-b36defaca682_58164a8f-22d9-49a1-b53c-b06953fbd48e.html,,,,,, Sodium nitrate,7631-99-4,"A reliable 28-day oral OECD 422 study has been performed in rats (5 rats/sex/dose) via gavage, containing 50, 750 or 1500 mg/kg bw/day potassium nitrate. There were no treatment-related deaths and no signs of overt clinical toxicity. There were no effects on body weight, food consumption, or food efficiency. Functional observational battery (FOB) and motor activity tests identified no treatment-related changes in behavior, function, or motor activity. No treatment-related histopathological changes were reported. Therefore, it was concluded that the NOAEL is ≥ 1500 mg KNO3/kg bw/day, ≥920 mg nitrate/kg bw/day (or higher, highest dose tested). A reliable 28 -day oral OECD 407, EU B.7 guideline study has been performed in rats (5 rats/sex/dose) via gavage, containing 50, 150 or 1000 mg/kg bw/day Nitcal-K (potassium pentacalcium nitrate decahydrate). There were no treatment-related deaths and no signs of overt clinical toxicity. There were no effects on body weight, food consumption, or food efficiency. Functional observational battery (FOB) and motor activity tests identified no treatment-related changes in behavior, function, or motor activity. In haematology high-dose males reticulocytes and red cell distribution width were slightly increased; in high-dose females red blood cell count and haematocrit was slightly decreased. Reviewer: these changes are not consistent between males/females, are very slight, and three out of four appeared to be in the historical control range from this strain (based on NOTOX historical data) and this kind of study. Therefore, these are not considered adverse. At gross pathology a thickened limiting ridge and/or foci in glandular mucosa in 2 and 3 high-dose males and females, respectively, were noted. This is a local effect and reversible. At histopathology some non-neoplastic effects were observed: hyperplasia/hyperkeratosis of the limiting ridge of the stomach in 4 and 3 high dose males and females, respectively. This is considered a local effect and reversible according to the reviewer. In addition an increased severity of haemopoietic foci (erythroid) in the spleen at high dose was noted. Reviewer: The effect in the spleen is limited to one male and one female with a moderate severity at the high dose. However, this is a symptom expected in young animals in such a study, in addition it is considered a reversible effect. This is based on expertise of an experienced pathologist. Therefore, it was concluded that the NOAELsystemic is ≥1000 mg Nitcal-K/kg bw/day, ≥56 mg nitrate/kg bw/day(highest dose tested).  In conclusion, no systemic adverse effects were observed up to and including the highest dose tested in two 28-day oral toxicity studies. The data from the 104-week carcinogenicity study in rats (Maekawa et al., 1982) do not indicate adverse toxic effects / carcinogenic potential of sodium nitrate. The Maekawa et al. (1982) study was used by SCF and EFSA for the derivation of the ADI.  F344 rats (50 animals per sex per group, 8 weeks old) were given 0%, 2.5% and 5% sodium nitrate in the diet ad libitum (equivalent to 0, 1250 and 2500 mg/kg bw per day, or 0, 910, or 1820 mg/kg bw per day expressed as nitrate ion) in a 2-year feeding study (Maekawa et al., 1982). Rats in the control group were given a basic diet without nitrate ad libitum. Treatment was stopped at week 104 and the rats were given a basic diet until week 123 to account for the number of survivors in at least one group of either sex that was less than 20%. Diet and water consumption was constant in all groups throughout the study. The growth curves showed that the mean body weight of male fats did not differ more than 10%, whereas female rats differed by more than 10% in the high-dose group after week 60. However, no statistically significant differences were reported for this parameter. Treatment with sodium nitrate did not have statistically significant effect on survival rates, although male rats in the 5% group (equivalent to 2500 mg sodium nitrate/kg bw per day, 1820 mg nitrate ion/kg bw per day) had 10% higher cumulative mortality compared to the 2.5% group (equivalent to 1250 mg sodium nitrate/kg bw per day, 910 mg nitrate ion/kg bw per day). At the end of the study (2 years), both male and female control groups showed a statistically significant lower number of survivors compared to both treatment groups. However, the mean survival time did not differ significantly among all groups. The incidence of tumours in all groups, including controls, was high. For example, the percentage of animals showing tumours in the control groups was reported to reach 94% and 92% for male and female rats, respectively. In male rats from the 2.5% sodium nitrate group (equivalent to 1250 mg/kg bw per day, 910 nitrate ion/kg bw per day), tumour incidence was reported to be 100%, whereas, in male rats from the 5% dose group (equivalent to 2500 mg/kg bw per day, 1820 mg nitrate ion/kg bw per day), the incidence was 96%. All other groups showed lower absolute tumour incidences than controls. The most commonly observed tumour in males was in the testes (interstitial cell) followed by the mammary gland, adrenal gland and liver. Tumours of the mammary gland, pituitary gland, uterus and adrenal gland were the most commonly observed tumours in females. Overall, there was no statistically significant difference of any specific tumour. The time of appearance of the first background tumour was not affected in any treatment group. Only the incidences of tumours of the haematopoietic organs were reported to be statistically significantly lower in the treated groups compared to controls, especially concerning mononuclear cell leukaemia. In conclusion, no adverse effects were observed up to and including the highest dose tested. Sodium nitrate did not have carcinogenic activity in F344 rats when administered continuously for 2 years. In conclusion, no carcinogenic effects were observed and the NOAEL for adverse toxic effects is ≥2500 mg sodium nitrate/kg bw/day, ≥1820 mg nitrate/kg bw/day (highest dose tested). Expert statement: Based on the existing data, read across and current ADI values no relevant toxicity after sub-chronic exposure is expected. Overall, generation of additional sub-chronic oral toxicity data is considered not scientifically justified and the sub-chronic oral toxicity study (90-days) thus waived. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed82962c-213b-49e7-a8e6-d8a88799b621/documents/e091d179-cc37-4f8f-924d-f1e063b890e3_1ffd09d3-d177-4a73-ae76-79491efeb7e8.html,,,,,, Sodium nitrate,7631-99-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed82962c-213b-49e7-a8e6-d8a88799b621/documents/e091d179-cc37-4f8f-924d-f1e063b890e3_1ffd09d3-d177-4a73-ae76-79491efeb7e8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,920 mg/kg bw/day,,rat Sodium nitrate,7631-99-4,"Several acute oral toxicity studies are present. Although one value of 1267 mg/kg bw in rat is below 2000 mg/kg bw, based on weight of evidence evaluation of the other studies available for sodium nitrate the LD50 is >2000 mg/kg bw. In addition,  no acute dermal toxicity study with the substance itself is present. However, a reliable study with potassium nitrate shows an LD50>5000 mg/kg bw. No acute inhalation toxicity study is required as the vapour pressure and the particle size do show that inhalation is a very unlikely route of exposure. The read-across rationale is attached in the target study record. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed82962c-213b-49e7-a8e6-d8a88799b621/documents/a2428c51-9883-4ef3-9ba5-e230ad98195c_1ffd09d3-d177-4a73-ae76-79491efeb7e8.html,,,,,, Sodium nitrate,7631-99-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed82962c-213b-49e7-a8e6-d8a88799b621/documents/a2428c51-9883-4ef3-9ba5-e230ad98195c_1ffd09d3-d177-4a73-ae76-79491efeb7e8.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Sodium nitrate,7631-99-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed82962c-213b-49e7-a8e6-d8a88799b621/documents/a2428c51-9883-4ef3-9ba5-e230ad98195c_1ffd09d3-d177-4a73-ae76-79491efeb7e8.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Sodium 2-biphenylate,132-27-4,"Oral: chronic toxicity, rat (OECD 453): NOAEL = 39 mg/kg bw/day, LOAEL = 200 mg/kg bw/day (RA from 2-phenylphenol, CAS 90-43-7)Inhalation: no data availableDermal: subacute toxicity, rat (OECD 410): NOAEL (systemic) ≥ 1000 mg/kg bw/day, local irritation (RA from 2-phenylphenol, CAS 90-43-7) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9cf8d164-15c8-438c-b61e-d8e451845e01/documents/6eff16dd-50f1-45cf-a5c5-0db34bd68196_bd48a2ca-8104-4e55-9bb0-57abfb013e12.html,,,,,, Sodium 2-biphenylate,132-27-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9cf8d164-15c8-438c-b61e-d8e451845e01/documents/6eff16dd-50f1-45cf-a5c5-0db34bd68196_bd48a2ca-8104-4e55-9bb0-57abfb013e12.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat Sodium 2-biphenylate,132-27-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9cf8d164-15c8-438c-b61e-d8e451845e01/documents/6eff16dd-50f1-45cf-a5c5-0db34bd68196_bd48a2ca-8104-4e55-9bb0-57abfb013e12.html,Chronic toxicity – systemic effects,oral,NOAEL,39 mg/kg bw/day,,rat Sodium 2-biphenylate,132-27-4," Acute oral toxicity (OECD 401): LD50 (rat) = 591 mg/kg bw Acute dermal toxicity (OECD 402): LD50 (rat) not determinable due to the corrosiveness of the test substance Acute dermal toxicity (similar to OECD 402): LD50 (rat) > 2000 mg/kg bw (RA from 2-phenylphenol, CAS 90-43-7) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9cf8d164-15c8-438c-b61e-d8e451845e01/documents/5676a636-0457-4e8b-8650-90c6e0c1ed46_bd48a2ca-8104-4e55-9bb0-57abfb013e12.html,,,,,, Sodium 2-biphenylate,132-27-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9cf8d164-15c8-438c-b61e-d8e451845e01/documents/5676a636-0457-4e8b-8650-90c6e0c1ed46_bd48a2ca-8104-4e55-9bb0-57abfb013e12.html,,oral,LD50,591 mg/kg bw,adverse effect observed, Sodium 2-hydroxy-3-[(2-hydroxyethyl)[2-[(1-oxo-9-octadecenyl)amino]ethyl]amino]propanesulphonate,68134-15-6, Oral: The LD50 of the test item was determined to be greater than 2000 mg/kg bodyweight. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ba09436-1e47-41ce-a4d7-afcac6781020/documents/e4b29f6f-e346-4a23-9666-594de5f65851_37dc45d2-5f39-407d-82d5-deb8a02b357d.html,,,,,, Sodium 2-hydroxy-3-[(2-hydroxyethyl)[2-[(1-oxo-9-octadecenyl)amino]ethyl]amino]propanesulphonate,68134-15-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ba09436-1e47-41ce-a4d7-afcac6781020/documents/e4b29f6f-e346-4a23-9666-594de5f65851_37dc45d2-5f39-407d-82d5-deb8a02b357d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate,3624-77-9,"Repeated dose toxicity oral: NOAEL = 1000 mg/kg bw/day (2-year study), based on read-across ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39c30456-230b-4379-be89-f129a8744f79/documents/IUC5-d76fb526-0a35-4209-949b-0b4bdcee9cd3_25214b38-1fd3-44d6-ab67-a12608ee792a.html,,,,,, Sodium N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate,3624-77-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39c30456-230b-4379-be89-f129a8744f79/documents/IUC5-d76fb526-0a35-4209-949b-0b4bdcee9cd3_25214b38-1fd3-44d6-ab67-a12608ee792a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, Sodium N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate,3624-77-9,"Oral (OECD 401), rat (m/f): LD50 > 5000 mg/kg bw (limit test), based on read-acrossInhalation (OECD 403), rat (m/f): LC50 = 1.37 mg/L, based on read-acrossDermal (OECD 402), rat (m/f): LD50 > 2000 mg/kg bw (limit test), based on read-across ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39c30456-230b-4379-be89-f129a8744f79/documents/IUC5-94163d32-272b-4dc2-802a-86cb768648d5_25214b38-1fd3-44d6-ab67-a12608ee792a.html,,,,,, Sodium N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate,3624-77-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39c30456-230b-4379-be89-f129a8744f79/documents/IUC5-94163d32-272b-4dc2-802a-86cb768648d5_25214b38-1fd3-44d6-ab67-a12608ee792a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate,3624-77-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39c30456-230b-4379-be89-f129a8744f79/documents/IUC5-94163d32-272b-4dc2-802a-86cb768648d5_25214b38-1fd3-44d6-ab67-a12608ee792a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate,3624-77-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39c30456-230b-4379-be89-f129a8744f79/documents/IUC5-94163d32-272b-4dc2-802a-86cb768648d5_25214b38-1fd3-44d6-ab67-a12608ee792a.html,,inhalation,LC50,"1,370 mg/m3",adverse effect observed, Disodium oxide,1313-59-3,"The instantaneous hydrolysis of disodium oxide (Na2O - n°CAS 1313 -59 -3) according the reaction: Na2O + H2O -> 2NaOH was confirmed by industrial practice (see section 5.1.2 of the IUCLID dossier). In contact with moist skin or mucous membranes (water), disodium oxide is quasi-instantaneously decomposed into sodium hydroxide. Disodium oxide appears then not available in the body due to its quasi-instantaneously degradation on contact with moist skin or mucous membranes. For these reasons, this approach was followed for the hazard characterization of disodium oxide: Short term toxicity and local toxicity endpoints were waived, based on corrosive potential and for animal welfare consideration Repeated toxicity endpoints were based on breakdown product (sodium hydroxide). There are sufficient data on the breakdown product (sodium hydroxide n°CAS: 1310 -73 -2) which were already evaluated (European RAR and REACH registration). This breakdown substance is exempted to Registration following Annex V (Entry I) for this register dossier. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9037dec6-c6b1-4025-bf94-1b5c487f49aa/documents/3ffc238b-6682-4b95-940a-bae4a901a38d_c2d36c61-2558-403f-b81b-12519fefc0d9.html,,,,,, Disodium oxide,1313-59-3," The instantaneous hydrolysis of disodium oxide (Na2O - n°CAS 1313 -59 -3) according the reaction: Na2O + H2O -> 2NaOH was confirmed by industrial practice (see section 5.1.2 of the IUCLID dossier). After the reaction, the pH of the solution is > 12. Therefore, disodium oxide is considered as corrosive and test for acute toxicity are not performed for animal welfare considerations. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9037dec6-c6b1-4025-bf94-1b5c487f49aa/documents/66d2f0d0-e1c2-42af-ad62-16f72287b6e2_c2d36c61-2558-403f-b81b-12519fefc0d9.html,,,,,, Sodium hydroxymethanesulphinate,149-44-0,It can be concluded that the No Observed Adverse Effect Level (NOAEL) for this study was 600 mg/kg/day and the No Observed Effect Level(NOEL) was 100 mg/kg/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/059c3a4e-5229-4b16-a1ab-0dd3065cf13f/documents/IUC5-e42db48a-abef-4bd7-bf81-c69ab78fefd2_862cd8e0-0d75-4287-80b2-b302167c9b46.html,,,,,, Sodium hydroxymethanesulphinate,149-44-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/059c3a4e-5229-4b16-a1ab-0dd3065cf13f/documents/IUC5-e42db48a-abef-4bd7-bf81-c69ab78fefd2_862cd8e0-0d75-4287-80b2-b302167c9b46.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat Sodium hydroxymethanesulphinate,149-44-0,LD50 (rat) oral > 5000 mg/kgLD50 (rat) dermal > 2000 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/059c3a4e-5229-4b16-a1ab-0dd3065cf13f/documents/IUC5-96fc8ab3-2a84-47a6-bcc7-0b40201df152_862cd8e0-0d75-4287-80b2-b302167c9b46.html,,,,,, Sodium hydroxymethanesulphinate,149-44-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/059c3a4e-5229-4b16-a1ab-0dd3065cf13f/documents/IUC5-96fc8ab3-2a84-47a6-bcc7-0b40201df152_862cd8e0-0d75-4287-80b2-b302167c9b46.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium hydroxymethanesulphinate,149-44-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/059c3a4e-5229-4b16-a1ab-0dd3065cf13f/documents/IUC5-96fc8ab3-2a84-47a6-bcc7-0b40201df152_862cd8e0-0d75-4287-80b2-b302167c9b46.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium p-chloro-m-cresolate,15733-22-9," Subchronic repeated dose toxicity, oral (similar to OECD 408), rat: NOAEL >= 1500 ppm (equivalent to 120 and 167 mg/kg bw/day in males and females, respectively) Subchronic repeated dose toxicity, dermal (similar to OECD 411), rat: NOAEL >= 500 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c28aa904-ce8c-4809-89ba-74672bac0de7/documents/475de141-229b-433e-8584-aac910dfaf51_8186f79c-0846-4425-b11d-36fb3b39f82d.html,,,,,, Sodium p-chloro-m-cresolate,15733-22-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c28aa904-ce8c-4809-89ba-74672bac0de7/documents/475de141-229b-433e-8584-aac910dfaf51_8186f79c-0846-4425-b11d-36fb3b39f82d.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,50 mg/m3,,rat Sodium p-chloro-m-cresolate,15733-22-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c28aa904-ce8c-4809-89ba-74672bac0de7/documents/475de141-229b-433e-8584-aac910dfaf51_8186f79c-0846-4425-b11d-36fb3b39f82d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat Sodium p-chloro-m-cresolate,15733-22-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c28aa904-ce8c-4809-89ba-74672bac0de7/documents/475de141-229b-433e-8584-aac910dfaf51_8186f79c-0846-4425-b11d-36fb3b39f82d.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rat Sodium p-chloro-m-cresolate,15733-22-9," Oral, rat: LD50 = 1610 mg/kg bw (males), LD50 = 1360 mg/kg bw (females) Inhalation (OECD 403), rat: LC50 > 2.871 mg/L air Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c28aa904-ce8c-4809-89ba-74672bac0de7/documents/8179bae9-f680-435f-8e60-12dca99e5cf0_8186f79c-0846-4425-b11d-36fb3b39f82d.html,,,,,, Sodium p-chloro-m-cresolate,15733-22-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c28aa904-ce8c-4809-89ba-74672bac0de7/documents/8179bae9-f680-435f-8e60-12dca99e5cf0_8186f79c-0846-4425-b11d-36fb3b39f82d.html,,oral,LD50,"1,360 mg/kg bw",adverse effect observed, Sodium p-chloro-m-cresolate,15733-22-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c28aa904-ce8c-4809-89ba-74672bac0de7/documents/8179bae9-f680-435f-8e60-12dca99e5cf0_8186f79c-0846-4425-b11d-36fb3b39f82d.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, Sodium p-chloro-m-cresolate,15733-22-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c28aa904-ce8c-4809-89ba-74672bac0de7/documents/8179bae9-f680-435f-8e60-12dca99e5cf0_8186f79c-0846-4425-b11d-36fb3b39f82d.html,,inhalation,LC50,"2,871 mg/m3",adverse effect observed, Sodium 5-oxo-L-prolinate,28874-51-3,"Repeat dose toxicity oral: male NOAEL 7200 mg/kg bw/day, female NOAEL 8200 mg/kg bw/day, similar to OECD 408, Ishii 1992. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6396bb7a-533e-46b6-aa78-1ac680e72e12/documents/IUC5-1fe9f6a4-ef27-4585-9be5-f15a5a3f479d_f8ac800a-23c5-4c4a-80cf-20292acc6481.html,,,,,, Sodium 5-oxo-L-prolinate,28874-51-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6396bb7a-533e-46b6-aa78-1ac680e72e12/documents/IUC5-1fe9f6a4-ef27-4585-9be5-f15a5a3f479d_f8ac800a-23c5-4c4a-80cf-20292acc6481.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"7,200 mg/kg bw/day",,rat Sodium 5-oxo-L-prolinate,28874-51-3,"Oral: LD50 > 2000 mg/kg bw, OECD 423, EU Method B. 1 tris, Kiss 2012a.Dermal: LD50 > 2000 mg/kg, OECD 402, EU Method B. 3, EPA OPPTS 870. 1200, Kiss 2012b. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6396bb7a-533e-46b6-aa78-1ac680e72e12/documents/IUC5-aba3083d-0f20-4ff1-b7d8-bffc8f05a147_f8ac800a-23c5-4c4a-80cf-20292acc6481.html,,,,,, "Perboric acid, sodium salt",11138-47-9,"Reliable studies are available for oral application as well as for dermal application.Oral (Zechel, 1989):Study design according to OECD Guideline No. 407NOAEL: < 1000 mg/kg bw (only one dose tested)Dermal (King, 1966):Study design: no Guideline followedNOAEL: 200 mg/kg bw ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/40b0ba73-cacf-49d7-800e-e259ec09acf0/documents/IUC5-2ff6d7fb-e7bb-409b-ba6c-500c7c6df93f_4e183e20-ae95-4fd5-aa55-28151165b758.html,,,,,, "Perboric acid, sodium salt",11138-47-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/40b0ba73-cacf-49d7-800e-e259ec09acf0/documents/IUC5-2ff6d7fb-e7bb-409b-ba6c-500c7c6df93f_4e183e20-ae95-4fd5-aa55-28151165b758.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,"1,000 mg/kg bw/day",,rat "Perboric acid, sodium salt",11138-47-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/40b0ba73-cacf-49d7-800e-e259ec09acf0/documents/IUC5-2ff6d7fb-e7bb-409b-ba6c-500c7c6df93f_4e183e20-ae95-4fd5-aa55-28151165b758.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,200 mg/kg bw/day,,rabbit "Perboric acid, sodium salt",11138-47-9,"oral LD50 (rat; m/f): 1120 mg/kg bw (key study: Glaza, 1988)inhalation LC50 (4 hrs; rat; m): ca. 1165 mg/m3 (key study: Valentine, 1987)dermal LD50 (NZW rabbit; m/f): > 2000 mg/kg bw (key study: Cerven, 1987) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40b0ba73-cacf-49d7-800e-e259ec09acf0/documents/IUC5-44761478-5fb4-466d-93cb-b5a2d13cb6c3_4e183e20-ae95-4fd5-aa55-28151165b758.html,,,,,, "Perboric acid, sodium salt",11138-47-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40b0ba73-cacf-49d7-800e-e259ec09acf0/documents/IUC5-44761478-5fb4-466d-93cb-b5a2d13cb6c3_4e183e20-ae95-4fd5-aa55-28151165b758.html,,oral,LD50,"1,120 mg/kg bw",, "Perboric acid, sodium salt",11138-47-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40b0ba73-cacf-49d7-800e-e259ec09acf0/documents/IUC5-44761478-5fb4-466d-93cb-b5a2d13cb6c3_4e183e20-ae95-4fd5-aa55-28151165b758.html,,dermal,LD50,"2,000 mg/kg bw",, "Perboric acid, sodium salt",11138-47-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40b0ba73-cacf-49d7-800e-e259ec09acf0/documents/IUC5-44761478-5fb4-466d-93cb-b5a2d13cb6c3_4e183e20-ae95-4fd5-aa55-28151165b758.html,,inhalation,LC50,"1,165 mg/m3",, tridecafluorooctyl-phosphonic acid sodium salt (1:1),1189052-95-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9840af41-1e35-4556-88ae-f1bcc21d37a5/documents/IUC5-774f67de-c620-44fd-92d5-b9192256fc2f_1dcec42b-40cd-4cf3-9af5-4a5972edb8fc.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Sodium dihydrogenorthophosphate,7558-80-7,"The key information has been provided on the analogous substance sodium aluminium phosphate. The key study (Matalski K, 1972b) has been selected as the most reliable or appropriate study for use in the derivation of DNELS. In addition a reliable 28 day study (OECD 422) exists for the analogous substance dipotassium hydrogenorthophosphate (Shim, 2005), however as the study is only a 28-day study and in accordance with Annex XI, Section 3.2 (a.ii) of Regulation (EC) N0. 1907/2006 (REACH) the data are not considered to be suitable for derivation of a DNEL as subchronic data are available. Furthermore, full access to the data has not been granted to all registrants.Additional supporting data provided on sodium dihydrogenorthophosphate are not considered to fulfil the guideline requirements for repeated dose toxicity (sub-chronic or chronic). Full justification for the choice of data and the rationale for read-across can be found below. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6b191e8-c7e2-4445-90ee-75dd0b1893e9/documents/IUC5-40d06ab7-c2ea-4dff-9e76-a0364f6774ab_fd9cc85c-39e2-4abf-8d73-0c4830ca583f.html,,,,,, Sodium dihydrogenorthophosphate,7558-80-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6b191e8-c7e2-4445-90ee-75dd0b1893e9/documents/IUC5-40d06ab7-c2ea-4dff-9e76-a0364f6774ab_fd9cc85c-39e2-4abf-8d73-0c4830ca583f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,322.88 mg/kg bw/day,,dog Sodium dihydrogenorthophosphate,7558-80-7,"Acute oral toxicity: Three studies are available to assess the acute oral toxicity of sodium dihydrogenorthophosphate. All studies indicate that sodium dihydrogenorthophosphate has a low potential for systemic toxicity following acute administration via the oral route. The key study (Bradshaw J , 2009) has been conducted according to a current guideline (OECD 420) according to the principles of GLP. The acute oral median dose (LD50) of sodium dihydrogenorthophosphate in the female Wistar strain rat was estimated to be > 2000 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP). Additional supporting data (Birch MD, 1973 and Bullock CH, 1972) are considered to be sufficient to support the overall classification; however these studies are not sufficient as stand-alone data sources for this endpoint.Acute inhalation toxicity: One key study is available to assess the acute inhalation toxicity of sodium dihydrogenorthophosphate. Sodium dihydrogenorthophosphate is considered to exhibit a low potential toxicity via the inhalation route and is not expected to be of significant concern. The key study (Signorin J, 1993) has been conducted according to the relevant guidelines (EU and US) and according to the principles of GLP. The acute inhalation median concentration (LC50) of sodium dihydrogenorthophosphate in male and female rats was estimated to be > 0.83 mg/L (the maximum attainable concentration). Acute dermal toxicity: One key study and a number of supporting studies are provided. All studies support no classification. The key study (Moore, 2006) details the acute dermal toxicity of the analogue substance potassium pentahydrogen bis(phosphate) which has an LD50 of >2,000 mg /kg bw and is therefore no classified according to Regulation (EC) No 1272/2008 (EU CLP). This classification can be read across to sodium dihydrogenorthophosphate on the basis of the argumentation provided below (see discussion box). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6b191e8-c7e2-4445-90ee-75dd0b1893e9/documents/IUC5-39000274-184f-453c-b1af-d29fe0bd9ac1_fd9cc85c-39e2-4abf-8d73-0c4830ca583f.html,,,,,, "Myo-Inositol, hexakis(dihydrogen phosphate), sodium salt",14306-25-3," Acute Toxicity Oral (read across), rat (Fischer 344/DuCrj) m / f: LD50: 1030 mg/kg bw (male); 1200 mg/kg bw (female) Acute Toxicity Oral (read across), mice (ICL-ICR) m / f: LD50: 1030 mg/kg bw (male); 2750 mg/kg bw (female) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99b235ad-558b-4904-aa7d-b66954ca5da7/documents/6537224b-7f12-43f0-8e14-874a991d2aeb_4d3df647-7f32-458a-88e3-5e186bd2676d.html,,,,,, "Myo-Inositol, hexakis(dihydrogen phosphate), sodium salt",14306-25-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99b235ad-558b-4904-aa7d-b66954ca5da7/documents/6537224b-7f12-43f0-8e14-874a991d2aeb_4d3df647-7f32-458a-88e3-5e186bd2676d.html,,oral,LD50,"1,030 mg/kg bw",adverse effect observed, "Sodium 2-amino-4,6-dinitrophenoxide",831-52-7," Repeated dose toxicity: via oral route; NOAEL was  considered to be 20 mg/kg/day for test substance  in Wistar rats by oral (gavage) administration in a 14 day study. Repeated inhalation study: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance sodium 2-amino-4,6-dinitrophenolate ( 831-52-7) which is reported as 3.36E13mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical sodium 2-amino-4,6-dinitrophenolate is highly unlikely. Therefore this study is considered for waiver. Repeated dermal study; The acute toxicity value for sodium 2-amino-4,6-dinitrophenolate ( 831-52-7) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that sodium 2-amino-4,6-dinitrophenolate shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that sodium 2-amino-4,6-dinitrophenolate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e569b673-b668-41e7-abf1-3e03c9a6d454/documents/84690837-d78c-4632-af9b-e8093f3dfb37_e8050a50-eaba-413e-91cc-523f8a452373.html,,,,,, "Sodium 2-amino-4,6-dinitrophenoxide",831-52-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e569b673-b668-41e7-abf1-3e03c9a6d454/documents/84690837-d78c-4632-af9b-e8093f3dfb37_e8050a50-eaba-413e-91cc-523f8a452373.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "Sodium 2-amino-4,6-dinitrophenoxide",831-52-7," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is between 50 - 300 mg/kg bw, for acute oral toxicity. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified into the “Category 3” for acute oral toxicity. Acute Inhalation Toxicity: The acute toxicity inhalation study need not be conducted because exposure to humans via inhalation route is not likely taking into account the low vapour pressure of the substance, which is reported as 3.36E-13 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely. Therefore this study is considered for waiver.   Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e569b673-b668-41e7-abf1-3e03c9a6d454/documents/f0f30e60-0b05-4259-9573-492a7917c85b_e8050a50-eaba-413e-91cc-523f8a452373.html,,,,,, "Sodium 2-amino-4,6-dinitrophenoxide",831-52-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e569b673-b668-41e7-abf1-3e03c9a6d454/documents/f0f30e60-0b05-4259-9573-492a7917c85b_e8050a50-eaba-413e-91cc-523f8a452373.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "Sodium 2-amino-4,6-dinitrophenoxide",831-52-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e569b673-b668-41e7-abf1-3e03c9a6d454/documents/f0f30e60-0b05-4259-9573-492a7917c85b_e8050a50-eaba-413e-91cc-523f8a452373.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Ceramic materials and wares, chemicals",66402-68-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d863f19-19f4-4544-b7ad-a885a4c67555/documents/IUC5-f72d62d7-a74f-4549-8f08-e4fa365b3b44_8dbfa359-a274-4c1a-831b-2ed00504a5b3.html,,oral,LD50,"2,000 mg/kg bw",, "Ceramic materials and wares, chemicals",66402-68-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d863f19-19f4-4544-b7ad-a885a4c67555/documents/IUC5-f72d62d7-a74f-4549-8f08-e4fa365b3b44_8dbfa359-a274-4c1a-831b-2ed00504a5b3.html,,dermal,LD50,"2,000 mg/kg bw",, "Ceramic materials and wares, chemicals",66402-68-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d863f19-19f4-4544-b7ad-a885a4c67555/documents/IUC5-f72d62d7-a74f-4549-8f08-e4fa365b3b44_8dbfa359-a274-4c1a-831b-2ed00504a5b3.html,,inhalation,LC50,5 mg/m3,, Sodium propionate,137-40-6, The oral LD50 for the test substance was determined to be > 6500 mg/kg bw (reference 7.2.1 -1). The dermal LD50 for the test substance was determined to be > 2000 mg/kg bw (reference 7.3.1-1). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73f17c6a-1ae2-4256-b2cf-e96f7d843130/documents/08586f72-762b-41bc-b24f-ca94ad2283ee_784809fe-4d0b-4111-ae01-93e3ddaa9c1e.html,,,,,, Sodium propionate,137-40-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73f17c6a-1ae2-4256-b2cf-e96f7d843130/documents/08586f72-762b-41bc-b24f-ca94ad2283ee_784809fe-4d0b-4111-ae01-93e3ddaa9c1e.html,,oral,discriminating dose,"3,200 mg/kg bw",adverse effect observed, Sodium propionate,137-40-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73f17c6a-1ae2-4256-b2cf-e96f7d843130/documents/08586f72-762b-41bc-b24f-ca94ad2283ee_784809fe-4d0b-4111-ae01-93e3ddaa9c1e.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Sodium 4-propoxycarbonylphenoxide,35285-69-9, Based on an OECD-conform 90 days repated dose oral toxicity study in rats (OECD 408) for the source substance: NOAEL (male/female rat): 1000 mg/kg bw/d (see attached read-across justification) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e1cc647-7b85-476d-9faf-f36c8953ffb9/documents/852bf52b-4283-4276-9896-a2b87a0c30b7_6e5141de-3b7b-4e5e-9547-d99a035e14e2.html,,,,,, Sodium 4-propoxycarbonylphenoxide,35285-69-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e1cc647-7b85-476d-9faf-f36c8953ffb9/documents/852bf52b-4283-4276-9896-a2b87a0c30b7_6e5141de-3b7b-4e5e-9547-d99a035e14e2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium 4-propoxycarbonylphenoxide,35285-69-9," Oral (OECD 401), rat: > 5000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e1cc647-7b85-476d-9faf-f36c8953ffb9/documents/1c4504f3-904c-4d9b-8cb6-7464be6e0561_6e5141de-3b7b-4e5e-9547-d99a035e14e2.html,,,,,, Sodium pyruvate,113-24-6,"One repeated-dose key study, oral route on humans is available. This study is well documented and reliable and thus the basic for the DNEL calculation. One repeated-dose supporting study, inhalative route is available which mainly focussed on another test substance. Thus this study is not considered for the DNEL calculation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/71b8f908-85d5-4aec-9dda-b200604eb169/documents/09f22146-09d3-437c-8f4b-197cb2ef2986_39384002-6c35-4556-ad77-17d1873647c2.html,,,,,, Sodium pyruvate,113-24-6, In an acute toxicity study in mice the LD50 was determined to be 3533 mg/kg bw after subcutaneous injection. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71b8f908-85d5-4aec-9dda-b200604eb169/documents/b4cc4e8c-36f8-4b95-8a6d-16a6f29d877d_39384002-6c35-4556-ad77-17d1873647c2.html,,,,,, Sodium pyruvate,113-24-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71b8f908-85d5-4aec-9dda-b200604eb169/documents/b4cc4e8c-36f8-4b95-8a6d-16a6f29d877d_39384002-6c35-4556-ad77-17d1873647c2.html,,oral,LD50,"3,533 mg/kg bw",no adverse effect observed, "1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt",128-44-9," Repeated dose toxicity: Oral The purpose of this study was to evaluate the toxicity of the test chemical in Sprague-Dawley Rats. Sprague-Dawley Rats were given the test chemical in diet at dose of 20000 ppm (1000 mg/Kg). Body weight, food consumption, Haematology, Clinical chemistry, Urinalysis, gross and histopathology were examined in the treated animals. No Statistically significant difference were observed in body weight, Organ weight, food consumption, Haematology, Clinical chemistry, Urinalysis in treated as compared to control. No test material related lesions were observed during gross and microscopic studies. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) of the test chemical on Sprague-Dawley Rats in 13 weeks study was considered to be at a dose concentration of 20000 ppm (1000 mg/kg bw/day). Repeated dose toxicity: Inhalation The particle size distribution of the test substance was found to vary in the size of 53-500 µm, so the potential for the generation of inhalable forms is low. Moreover the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and therefore repeated dose toxicity by inhalation route was considered to be waived. Repeated dose toxicity: Dermal Since the substance is used in solid form there is very low probability of the substance penerating the skin. Further the results are negative for skin sensatization and skin irritation. Therefore this end point for repeated dose toxicity by dermal route of exposure was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6452aa3e-adee-4201-ac72-e3958fc16ba8/documents/3b2258ff-65c0-4e4a-a85e-c25706d0c700_60c85ddb-df05-42d4-8512-f05f6df905ca.html,,,,,, "1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt",128-44-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6452aa3e-adee-4201-ac72-e3958fc16ba8/documents/3b2258ff-65c0-4e4a-a85e-c25706d0c700_60c85ddb-df05-42d4-8512-f05f6df905ca.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt",128-44-9," Acute toxicity:Oral The acute oral median lethal dose (LD50) of test chemical in male/female sprague-dawley rat was determined to be 8440-9710 mg/kg of body weight. LD50 value indicates that the test chemical does not exhibits acute toxicity by the oral route. Acute Toxicity:Inhalation The particle size distribution of the test substance was found to vary in the size of 53-500 µm, so the potential for the generation of inhalable forms is low.Moreover the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and therefore acute toxicity by inhalation route was considered to be waived. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6452aa3e-adee-4201-ac72-e3958fc16ba8/documents/cef572be-b7af-4288-b777-85064d4eb5ae_60c85ddb-df05-42d4-8512-f05f6df905ca.html,,,,,, "1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt",128-44-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6452aa3e-adee-4201-ac72-e3958fc16ba8/documents/cef572be-b7af-4288-b777-85064d4eb5ae_60c85ddb-df05-42d4-8512-f05f6df905ca.html,,oral,LD50,"8,980 mg/kg bw",no adverse effect observed, "1,2-benzisothiazol-3(2H)-one 1,1-dioxide, sodium salt",128-44-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6452aa3e-adee-4201-ac72-e3958fc16ba8/documents/cef572be-b7af-4288-b777-85064d4eb5ae_60c85ddb-df05-42d4-8512-f05f6df905ca.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium salicylate,54-21-7,"Repeated dose toxcity: Oral The Low observed Adverse Effect level (LOAEL) for test chemical,sodium salicylate, CAS 54-21-7 was considered to be 400 mg/Kg/day. Repeated dose toxicity: Inhalation The test substance has very low vapor pressure, so the potential for the generation of inhalable forms is low, also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and therefore this end point was considered as waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value for Sodium salicylate (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not irritating and not sensitizing to the skin. Based on these considerations, the end point for repeated dermal toxicity is considered as waiver.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c97050b0-3f01-4ef0-ab20-5287ead7e6c7/documents/a094854c-e578-4c8e-937c-738a6337758b_335a8f8e-7d3a-48a6-8fc7-a1fff6afff66.html,,,,,, Sodium salicylate,54-21-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c97050b0-3f01-4ef0-ab20-5287ead7e6c7/documents/a094854c-e578-4c8e-937c-738a6337758b_335a8f8e-7d3a-48a6-8fc7-a1fff6afff66.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,400 mg/kg bw/day,,rat Sodium salicylate,54-21-7,"Acute oral toxicity: The lethal concentration (LD50) cut-off value for the acute oral toxicity test was considered to be 1000 mg/kg bw when female Wistar albino rats were treated with target test chemical Sodium salicylate (CAS No. 54-21-7) orally via gavage. According to the study the test chemical is classified in ""Category 4"" based on GHS criteria. Acute inhalation toxicity:  Sodium salicylate (CAS No. 54-21-7) has very low vapor pressure, so the potential for the generation of inhalable forms is low, also the normal conditions of use of this substance will not result in aerosols, particles, or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur, and therefore no inhalation test was performed and therefore the acute inhalation toxicity endpoint was considered for waiver. Acute dermal toxicity:  The LD50 value was considered to be >2000 mg/kg bw, when male and female Wistar rats were treated with target test chemical Sodium salicylate (CAS No. 54-21-7) by dermal application following 14 days of observation period. Therefore the test chemical is ""Not Classified"" for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c97050b0-3f01-4ef0-ab20-5287ead7e6c7/documents/71b95fda-82a4-456f-8062-6f86cb0c3c61_335a8f8e-7d3a-48a6-8fc7-a1fff6afff66.html,,,,,, Sodium salicylate,54-21-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c97050b0-3f01-4ef0-ab20-5287ead7e6c7/documents/71b95fda-82a4-456f-8062-6f86cb0c3c61_335a8f8e-7d3a-48a6-8fc7-a1fff6afff66.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, Sodium salicylate,54-21-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c97050b0-3f01-4ef0-ab20-5287ead7e6c7/documents/71b95fda-82a4-456f-8062-6f86cb0c3c61_335a8f8e-7d3a-48a6-8fc7-a1fff6afff66.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Sodium sarcosinate,4316-73-8,Sodium sarcosinate is of low oral toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b66aa63a-7d28-4ae8-956b-92a4d77b0545/documents/cf3d6d3f-8ed6-4b29-8075-57858b6994de_713d6c64-f330-44e3-95bc-9d0275140afa.html,,,,,, Sodium sarcosinate,4316-73-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b66aa63a-7d28-4ae8-956b-92a4d77b0545/documents/cf3d6d3f-8ed6-4b29-8075-57858b6994de_713d6c64-f330-44e3-95bc-9d0275140afa.html,,oral,LD50,"> 6,400 mg/kg bw",, Sodium sarcosinate,4316-73-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b66aa63a-7d28-4ae8-956b-92a4d77b0545/documents/cf3d6d3f-8ed6-4b29-8075-57858b6994de_713d6c64-f330-44e3-95bc-9d0275140afa.html,,inhalation,LC0,ca.3.41 mg/L,, Trisodium hydrogendicarbonate,533-96-0,The substance will quickly dissociate to sodium and carbonate ions in biological systems. Local irritation to respiratory tract may be felt and ingestion of large quantities may result in production of CO2 in contact with stomach acids. These are not considered to be toxic effects. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b69a0613-e7c6-4d4c-9da9-c26c1a8d5e94/documents/IUC5-cf4f3c79-411f-422a-a2da-735d1df18642_09cc13e8-ad24-4bcd-b1d0-ededa73dd362.html,,,,,, "Silicic acid, sodium salt",1344-09-8,NOAEL (rats) = 159 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcc9e979-feff-42fe-b8a0-37bb72893685/documents/496a0a95-2882-43e3-a307-19a35286941e_d69c9ffb-8755-4e54-ade4-75dfa556eb1f.html,,,,,, "Silicic acid, sodium salt",1344-09-8,oral: LD50 (rat) = 3400 mg/kg bwinhalation: LC50 (rat) > 2.06 g/m3dermal: LD50 (rat) > 5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcc9e979-feff-42fe-b8a0-37bb72893685/documents/831edb90-3e21-4bd5-ad9f-2ae1afee8c92_d69c9ffb-8755-4e54-ade4-75dfa556eb1f.html,,,,,, "Silicic acid, aluminum sodium salt",1344-00-9,"Oral No adverse effects were seen with the test substance Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS) in studies in mice and rats at very high doses of up to 100,000 ppm (10% in the diet) after 14 days of administration. The 28- and 90-day studies in the read-across substance silicon dioxide (SAS) also showed no adverse effects up to the highest or limit dose level applied, respectively, which was in both cases 1000 mg/kg bw/d.   Inhalation There is only a 5-day study in the test substance Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS) available, but an expert statement claims that this type of study is as expressive as 90-day ones for testing nanomaterials. In the mentioned 5-day study no adverse effects were observed in Wistar rats up to inhalation values of 21.93 mg/m³, which is above the GHS threshold level for repeated dose inhalation. All observed effects either did not differ from the control group or were at least regarded as not adverse, being without biological and toxicological relevance. Hence, the NOAEL was assessed as equal to or greater than 21.93 mg/m³. As there is no 28- or 90-day study in the test substance Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS) itself, a read-across approach was conducted via the structurally related substance silicon dioxide (SAS). Here, in the study performed by Creutzenberg (2014, OECD 413), under the conditions of this test, a LOAEL = 1 mg/m³ was derived (decisive endpoint: histopathology: mucous cell hyperplasia in nasal cavities). An experimental local NOAEL could not be derived (i.e. NOAEL < 1 mg/m³). But all effects showed either full reversible or showed a tendency to full reversibility.The systemic NOAEL was 5 mg/m³ effectively. At this dose level, no systemic effects were observed. The nominal systemic concentration applied higher, and can be calculated by dividing the stated nominal concentration of 16.13 mg/m³ air with the aerosol generation efficiency (effective vs. nominal concentration) of 31%: 16.13 mg/m³ air / 0.31 = 5 mg/m³ air. LOAEL (local): 1 mg/m³ (effective)LOAEL (local): 3.23 mg/m³ (nominal)No local NOAEL was identified, but all effects showed either full reversible or showed a tendency to full reversibility. NOAEL (systemic): > 5 mg/m³ (effective) NOAEL (systemic): > 16.13 mg/m³ (nominal) Creutzenberg, 2014, OECD 413: The target aerosol concentrations of 1, 2.5 and 5 mg / m³ were achieved to 104%, 100% and 101%, respectively. Calculation of the aerosol generation efficiency (actual vs. nominal concentration) resulted in 31%; this low value demonstrates that experimental conditions are different to any handling and use conditions of the tested silicon dioxide.  - Due to the particle size distribution in the test medium the nominal concentration was 3.23 mg/m³, to achieve 1 mg/m³ aerosol test concentration.  - Due to the particle size distribution in the test medium the nominal concentration was 8.06 mg/m³, to achieve 2.5 mg/m³ aerosol test concentration.  - Due to the particle size distribution in the test medium the nominal concentration was 16.13 mg/m³, to achieve 5 mg/m³ aerosol test concentration. This results in a NOAEL > 5 mg/m³ air corresponding to > 16.13 mg/m³ nominal concentration in air for the tested silicon dioxide. For local effects an experimental NOAEL could not be derived (i.e. NOAEL < 1 mg/m³) due to mucous cell hyperplasia in nasal cavities observed in all dose groups. But according to GHS (2019) 3.9.2.8 d this effect does not support classification, because it is an adaptive response not considered toxicologically relevant.Also, the increased lung weights in the medium and high dose groups do not support classification according to GHS (2019) 3.9.2.8 c, because no evidence of organ dysfunction was reported. Therefore, for the assessment of classification, no sufficient critical effects were observed up to the highest dose employed, hence no hazard was identified and a NOAEL of equal or greater than 16.13 mg/m³ is applicable for local effects when assessing classification.  Remark: #1 Under normal handling and use of commercial products, the silicas tend to form agglomerates of high mass median aerodynamic diameters that are not respirable (MMAD >> 10 μm). The respirable fraction (=< 10 μm) comprises less than 1 wt% (see Stintz 2003). Under experimental conditions, the MMADs may range below 10 μm, the respirable fractions accounting for more than 80 %.Reference: ECETOC (2006): Synthetic Amorphous Silica (CAS No. 7631-86-9). JACC Report No. 51, European Centre for Ecotoxicology and Toxicology of Chemicals, Brussels, September 2006 #2 Particle properties and relevance for specific hazards:Toxicological inhalation studies were performed typically by using a homogeneous atmosphere of the test substance (what is gained under application of high shear forces) with particles sizes that are much smaller compared to particle size distributions of the bulk material.As the inflammatory response in the lung will be determined by particle size and morphology rather than by particle composition: This means that in experimental studies due to the high shear forces applied, the toxicologically relevant particle fraction is assumed to be much higher than under workplace conditions. From this point, the results of the inhalation studies must be seen as a worst-case scenario that appears unlikely under usual workplace conditions.   Dermal No dermal repeated dose study is available, but based on the high acute tolerance and the inert inorganic nature of silica, silicates and aluminium one also does not seem to be necessary. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): reliability 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): reliability 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliability 2 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e1fdfdd-ce5b-49de-ae0e-128170fe42ee/documents/abb08481-de5d-4d2c-a454-58305cdc078c_fadd1841-e689-4163-8f00-6798b11da9eb.html,,,,,, "Silicic acid, aluminum sodium salt",1344-00-9,"Oral: In none of the studies in the test substance Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS) and structurally related Silicic acid, aluminum magnesium sodium salt (CAS 12040-43-6, SMAS) mortality was observed. In the only reliable study in the test substance two nanoforms of Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS) were tested at doses of 5000 mg/kg bw without mortality or gross pathological abnormalities. Therefore, no hazard was identified in the assessment of the test substance Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS).   Inhalation: Only one study in Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS) is available (all other studies are in read-across substances). In this study, according to the OECD TG 436, the acute lethal dose for inhalation route could not be determined for the tested nanoform of Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS), since no mortality or any toxic event could be registered at an actual dose level of 65.9 mg/m³. Thus, the test item showed an acute inhalation LC50 cut-off greater than 85.6 mg/m³. This was the only dose tested. A much higher concentration was employed in a study with the read-across substance Silicic acid, aluminum magnesium sodium salt (CAS 12040-43-6, SMAS), here, a LC50 of > 5221 mg/l was assessed with no mortality observed.   Dermal: Only one study in Silicic acid, aluminum sodium salt (CAS 1344-00-9, NAS) is available (the others are in read-across substances). In this study, no mortality was observed up to 5000 mg/kg bw. The same result was attained in all other studies (in read-across substances): No mortality was observed up to the highest dose level. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliablity 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): reliability: 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): reliabilty: 2 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e1fdfdd-ce5b-49de-ae0e-128170fe42ee/documents/4fbcc71e-9263-4931-88ab-09c337bb8b5b_fadd1841-e689-4163-8f00-6798b11da9eb.html,,,,,, "Silicic acid, aluminum sodium salt",1344-00-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e1fdfdd-ce5b-49de-ae0e-128170fe42ee/documents/4fbcc71e-9263-4931-88ab-09c337bb8b5b_fadd1841-e689-4163-8f00-6798b11da9eb.html,,oral,LD0,">=5,000 mg/kg bw",no adverse effect observed, "Silicic acid, aluminum sodium salt",1344-00-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e1fdfdd-ce5b-49de-ae0e-128170fe42ee/documents/4fbcc71e-9263-4931-88ab-09c337bb8b5b_fadd1841-e689-4163-8f00-6798b11da9eb.html,,dermal,LD0,">=5,000 mg/kg bw",no adverse effect observed, "Silicic acid, aluminum sodium salt",1344-00-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e1fdfdd-ce5b-49de-ae0e-128170fe42ee/documents/4fbcc71e-9263-4931-88ab-09c337bb8b5b_fadd1841-e689-4163-8f00-6798b11da9eb.html,,inhalation,LC50,> 85.6 mg/m3,no adverse effect observed, Disodium tin trioxide,12058-66-1," According to the relvant study for subacute chronic toxicity a NOAL of 1 % in diet was determined. Under consideration of a body of 250g / rat the folowing NOAEL could be calculated from the raw data: NOAEL (male( = 517.14 mg SnO2/kg bw day NOAEL(female) 408,57 mg SnO2 /kg bw day. So the female aninal is the most sensitive species, thus the NOAEL for Sodiums stabbate is 723.01 mg / kg /bw day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/361dcd46-43e0-4a2b-ba9b-957d510ee9e1/documents/3a5c8b67-5486-479f-b67d-863bbf4a29b6_30123ad4-ba90-40b9-9482-6451f896d238.html,,,,,, Disodium tin trioxide,12058-66-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/361dcd46-43e0-4a2b-ba9b-957d510ee9e1/documents/3a5c8b67-5486-479f-b67d-863bbf4a29b6_30123ad4-ba90-40b9-9482-6451f896d238.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,723.09 mg/kg bw/day,,rat Sodium 2-stearoyllactate,25383-99-7," Acute oral toxicity: LD50 (rat, m) > 5000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bfa7706-79b1-4ad0-a52f-fc6f007d0d5a/documents/050e56e9-a1fe-46c1-9fdf-daf6dc661273_bf1c8d37-3705-444f-9c77-9e1606387542.html,,,,,, Sodium sulphanilate,515-74-2,Key study: Acute oral toxicity study. OECD guideline and EU method. GLP study.The oral LD50 for the test substance was greater than 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4297761f-f9c6-4e03-9664-8e8fed6a2690/documents/IUC5-467acda7-d976-48c9-84ef-ed0fc3e1eb8f_d78a729a-fba4-44ee-8830-2c6c44baac34.html,,,,,, Sodium sulphanilate,515-74-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4297761f-f9c6-4e03-9664-8e8fed6a2690/documents/IUC5-467acda7-d976-48c9-84ef-ed0fc3e1eb8f_d78a729a-fba4-44ee-8830-2c6c44baac34.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Sodium sulphate,7757-82-6,"In a sub-acute oral toxicity study with sodium sulfate no adverse effects were noted. A recent study was to set the NOAEL. This NOAEL (oral, rat) is set at 1000 mg/kg bw/day.   ORAL Ceccatelli R., 2010 OECD 421 Main Study C79103: The NOAEL 28 d (rat ,oral ) is 1000 mg/kg/day Moinuddin & Wing-tsit Lee, 1960: the NOAEL 28 d (rat, oral) from this study is 2000 mg/kg/day   DERMAL Data with respect to repeated dermal toxicity show effects. Male and female New Zealand White Rabbits were treated with the test substance (2 ml/kg/day; 16 % w/w) percutaneously 65 times in 91 days. The only test related effect, which was observed for all groups, was subacute dermatitis that varied from mild to moderate in nature. All other findings were normal or related to spontaneous disease. Some lesions were incidental in nature. LOAEL for the test substance was 2 ml/kg/day (16 % w/w), is 320 mg/kg/day sodium sulphate.     INHALATION In the available repeated dose study the description of the experiment is insufficient and no actual data are presented. No NOAEL or LOAEL. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe6bca36-0f69-4310-9299-e6eb02553475/documents/IUC5-c54e5daa-c9d1-4e02-8561-f77ea2a2eaab_e8f1db3e-1a97-4526-ba50-83591cd25ad7.html,,,,,, Sodium sulphate,7757-82-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe6bca36-0f69-4310-9299-e6eb02553475/documents/IUC5-c54e5daa-c9d1-4e02-8561-f77ea2a2eaab_e8f1db3e-1a97-4526-ba50-83591cd25ad7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium sulphate,7757-82-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe6bca36-0f69-4310-9299-e6eb02553475/documents/IUC5-c54e5daa-c9d1-4e02-8561-f77ea2a2eaab_e8f1db3e-1a97-4526-ba50-83591cd25ad7.html,Sub-chronic toxicity – systemic effects,dermal,LOAEL,320 mg/kg bw/day,,rat Sodium sulphate,7757-82-6," Test results available for acute toxicity rat (oral and inhalation). LC50, 4h (rat, inhalation) > 2400 mg/m3 air LCLo, 72h (rat, inhalation) > 10 mg/m3 air Based on the results of several acute toxicity inhalation studies it is unlikely that short-term inhalation of respirable sodium sulfate particles cause pulmonary irritation or systemic effects; The acute dermal toxicity (rat) is waived: Annex XI adaptation- inorganic ionic substance low potential for absorption through the skin.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe6bca36-0f69-4310-9299-e6eb02553475/documents/IUC5-259675d8-97ff-458c-b680-7d5108499483_e8f1db3e-1a97-4526-ba50-83591cd25ad7.html,,,,,, Sodium sulphate,7757-82-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe6bca36-0f69-4310-9299-e6eb02553475/documents/IUC5-259675d8-97ff-458c-b680-7d5108499483_e8f1db3e-1a97-4526-ba50-83591cd25ad7.html,,inhalation,LC50,"2,400 mg/m3",, Disodium sulphide,1313-82-2,"In the key study, the 90-day inhalation toxicity study with exposure of rats and mice to hydrogen sulfide (Dorman et al., 2004), no toxicologically relevant alterations in haematological indices, serum chemistries, or gross pathology. Therefore, the highest concentration of 80 ppm H2S may be considered as NOAEC for systemic effects. When comparing the results of the available sub-chronic studies in rats and mice, it becomes obvious that the findings of these inhalation studies are not contradictory. Brennemann et al. (2000), Moulin et al. (2002) and Dorman et al. (2004) found similar targets of toxicity. The main adverse effect caused by 30 and 80 ppm hydrogen sulfide was an exposure-related increased incidence of olfactory neuronal loss (ONL). Thus, the concentration of 10 ppm H2S represents an NOAEC for local effects in the olfactory system. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfbe8d48-2b1d-465f-b457-f01902b181ef/documents/IUC5-11839e21-73ef-4e2e-92e9-3b8630291e04_286c89a8-d301-41f9-a0ab-35f56265776c.html,,,,,, Disodium sulphide,1313-82-2,"Acute oral toxicity: Acute oral toxicity of sodium sulfide is assessed using a weight-of-evidence approach. Two reliable studies (RL=1) with Na2S were included. An LD50 of 254 mg/kg bw could be derived for sodium sulfide (60 %) from the Ullmann (1986) study report. The result indicates that the LD50 calculated for the most concentrated commercial form Na2S, 62 %, would be 246 mg/kg bw. Second, an LD50 of 1122 mg/kg bw was calculated for sodium sulfide (anhydrous) in the study by Mason (1998). The result indicates that the LD50 calculated for the most concentrated commercial form Na2S, 62 %, would be 1810 mg/kg bw. Based on a comparison with sodium hydrogensulfide as an analogous substance, the lower LD50 value will be used for classification.Acute inhalation toxicity: no reliable studies available, but minimal risk of inhalation concluded.Acute dermal toxicity: No reliable studies available; the Seaman (1982) study (RL=3), despite being regarded as clearly invalid, is reported since the current legal classification is based on this study result (LD50<340 mg/kg bw). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfbe8d48-2b1d-465f-b457-f01902b181ef/documents/IUC5-e620ef54-e7c0-434e-a696-1e3a74e09e6a_286c89a8-d301-41f9-a0ab-35f56265776c.html,,,,,, Sodium sulphite,7757-83-7,"A 3-generation chronic toxicity study (Til et al. 1972a) with treatment of rats (20 per sex and group) with dose levels of 0, 0.125, 0.25, 0.5, 1.0 or 2.0% Na2S2O5 administered in a 50 ppm thiamine-containing diet was identified as most reliable study for repeated dose toxicity and was defined as key study (read-across info, see `discussion`). Based on the read across concept for the group of sulfite substances, this result is also applicable to sodium sulfite. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfd57f5a-29c6-4dd1-aacb-3d9c2a2e1c04/documents/IUC5-96e3db7c-a7d7-4e45-9428-e842f8f87eb5_571570b0-780a-4c99-ab51-65561eedcd12.html,,,,,, Sodium sulphite,7757-83-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfd57f5a-29c6-4dd1-aacb-3d9c2a2e1c04/documents/IUC5-96e3db7c-a7d7-4e45-9428-e842f8f87eb5_571570b0-780a-4c99-ab51-65561eedcd12.html,Chronic toxicity – systemic effects,oral,NOAEL,143 mg/kg bw/day,,rat Sodium sulphite,7757-83-7,"Based on the described read-across methodology information from sodium sulfite (CAS 7757-83-7), sodium metabisulfite (CAS 7681 -57 -4) and potassium metabisulfite (CAS 16731 -55 -8) were used to determine acute toxicity values (oral, dermal and inhalative) for sodium sulfite.Acute toxicity, oral: LD50 >2610 mg/kg bwAcute toxicity, dermal: LD50 >2000 mg/kg bwAcute toxicity, inhalation: LC50 >5.5 mg/l ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfd57f5a-29c6-4dd1-aacb-3d9c2a2e1c04/documents/IUC5-6c912e9f-01ab-4ecc-a3cb-d933e061df08_571570b0-780a-4c99-ab51-65561eedcd12.html,,,,,, Sodium mercaptoacetate,367-51-1,"The repeated dose toxicity of sodium mercaptoacetate has been evaluated by oral and dermal administrations. In an oral repeated dose toxicity study (OECD 408), sodium mercaptoacetate was administered by gavage, 7 days/week, for 13 weeks, to male and female Sprague-Dawley rats. Sporadic mortality and fully reversible effects on some haematological and biochemical parameters and histopathological changes in liver were observed at 60 mg/kg bw/d. These effects may be related to the inhibition of the β-oxidation of fatty acids a known mechanism of action of sodium mercaptoacetate. Consequently, based on the effects observed at 60 mg a. i. /kg/day, particularly mortality, hematological and significant blood chemistry changes associated with liver microscopic changes and the limited blood chemistry effects without microscopic adverse changes in the liver observed at 20 mg a. i. /kg/day, the NOAEL of sodium mercaptoacetate was 20 mg a. i. /kg/day, and the NOEL was 7 mg a. i. /kg/day given by daily oral administration (gavage) to rats for 13 weeks. Additional information on the oral repeated dose toxicity of sodium mercaptoacetate is provided by the 2-generation reprotoxicity study (OECD 416) study and the reproduction/developmental screening test (OECD 421). The results of both studies support the NOAEL 20 mg a. i. /kg/day defined in the 13-week toxicity study. In a repeated dose dermal toxicity (OECD 411), sodium mercaptoacetate was administered via dermal route, 5 days per week, for 13 weeks to male and female Fischer 344 rats and B6C3F1 mice. All animals survived the 13 weeks administration. The only treatment related effect was skin irritation at the site of application. The LOELs for skin irritation were 11.25 and 45 mg/kg bw/d and the NOAELs for systemic toxicity were higher than 180 and 360 mg/kg bw/d in rats and mice, respectively.     ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49821042-e808-4e16-a751-0ed0f8449466/documents/711583f5-2928-4db8-8bc7-f0c5e8e08d0f_f313895f-0795-4d48-9c7d-1a39c3468f06.html,,,,,, Sodium mercaptoacetate,367-51-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49821042-e808-4e16-a751-0ed0f8449466/documents/711583f5-2928-4db8-8bc7-f0c5e8e08d0f_f313895f-0795-4d48-9c7d-1a39c3468f06.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat Sodium mercaptoacetate,367-51-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49821042-e808-4e16-a751-0ed0f8449466/documents/711583f5-2928-4db8-8bc7-f0c5e8e08d0f_f313895f-0795-4d48-9c7d-1a39c3468f06.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,180 mg/kg bw/day,,rat Sodium mercaptoacetate,367-51-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49821042-e808-4e16-a751-0ed0f8449466/documents/711583f5-2928-4db8-8bc7-f0c5e8e08d0f_f313895f-0795-4d48-9c7d-1a39c3468f06.html,Repeated dose toxicity – local effects,dermal,LOAEL,63 ,adverse effect observed, Sodium mercaptoacetate,367-51-1,NaTG is toxic by ingestion and harmful in contact with skin. LD50 determined with NaTG (LD50 is >1000 mg/kg bw for female rats. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49821042-e808-4e16-a751-0ed0f8449466/documents/a7f08b7b-db36-43fc-9ef0-7dc9a5615258_f313895f-0795-4d48-9c7d-1a39c3468f06.html,,,,,, Sodium mercaptoacetate,367-51-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49821042-e808-4e16-a751-0ed0f8449466/documents/a7f08b7b-db36-43fc-9ef0-7dc9a5615258_f313895f-0795-4d48-9c7d-1a39c3468f06.html,,oral,LD50,50 mg/kg bw,adverse effect observed, Sodium mercaptoacetate,367-51-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49821042-e808-4e16-a751-0ed0f8449466/documents/a7f08b7b-db36-43fc-9ef0-7dc9a5615258_f313895f-0795-4d48-9c7d-1a39c3468f06.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, Sodium thiosulphate,7772-98-7,"A 3-generation chronic toxicity study (Til et al. 1972a) with treatment of rats (20 per sex and group) with dose levels of 0, 0.125, 0.25, 0.5, 1.0 or 2.0% Na2S2O5 administered in a 50 ppm thiamine-containing diet was identified as most reliable study for repeated dose toxicity and was defined as key study (read-across info, see `discussion`). Based on the read across concept for the group of sulfite and thiosulfate substances, this result is also applicable to sodium thiosulfate. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24702444-bd9b-489e-ae4d-ce2aecc248c6/documents/IUC5-15752051-1833-4738-9c3d-80c77ca32fc1_c579b53a-1860-4fd0-be4e-de08b7683eb8.html,,,,,, Sodium thiosulphate,7772-98-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24702444-bd9b-489e-ae4d-ce2aecc248c6/documents/IUC5-15752051-1833-4738-9c3d-80c77ca32fc1_c579b53a-1860-4fd0-be4e-de08b7683eb8.html,Chronic toxicity – systemic effects,oral,NOAEL,180 mg/kg bw/day,,rat Sodium thiosulphate,7772-98-7,"Acute toxicity values (oral, dermal and inhalative) were determined for sodium thiosulfate utilising data from read-across to sodium sulfite (CAS 7757-83-7), potassium thiosulfate (CAS 10294-66-3) and calcium thiosulfate (10124-41-1)Please see discussion below. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24702444-bd9b-489e-ae4d-ce2aecc248c6/documents/IUC5-9e428848-9a61-427e-a00d-010b025a0958_c579b53a-1860-4fd0-be4e-de08b7683eb8.html,,,,,, Sodium toluene-4-sulphonate,657-84-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de8a2f5e-bee2-4be6-a1c3-3793457a3081/documents/4e69c9cd-a108-49c3-b557-ef3afc410b1f_765c3a21-a8cf-40dd-bd48-cc1f81e374ee.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,763 mg/kg bw/day,,rat Sodium toluene-4-sulphonate,657-84-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de8a2f5e-bee2-4be6-a1c3-3793457a3081/documents/4e69c9cd-a108-49c3-b557-ef3afc410b1f_765c3a21-a8cf-40dd-bd48-cc1f81e374ee.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.48 mg/cm2,adverse effect observed,rat Sodium toluene-4-sulphonate,657-84-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de8a2f5e-bee2-4be6-a1c3-3793457a3081/documents/651de888-a578-49bc-aafb-021de4595929_765c3a21-a8cf-40dd-bd48-cc1f81e374ee.html,,oral,LD50,"3,346 mg/kg bw",adverse effect observed, Sodium toluene-4-sulphonate,657-84-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de8a2f5e-bee2-4be6-a1c3-3793457a3081/documents/651de888-a578-49bc-aafb-021de4595929_765c3a21-a8cf-40dd-bd48-cc1f81e374ee.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium toluene-4-sulphonate,657-84-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de8a2f5e-bee2-4be6-a1c3-3793457a3081/documents/651de888-a578-49bc-aafb-021de4595929_765c3a21-a8cf-40dd-bd48-cc1f81e374ee.html,,inhalation,LC50,"6,410 mg/m3",no adverse effect observed, Trisodium trimetaphosphate,7785-84-4,"Repeated dose toxicity: oral;Four studies are available for this endpoint:- A key study (Hodge HC 1960) performed in rats demonstrates that there is not specific target organ toxicity when administered ad libitum in the diets of male and female rats for a period of 2 years. The data for this key study are sufficient to infer that that test material should not be classified for STOT-RE under the EU CLP Regulation. A toxicologist expert assessment of the key study is provided to support this conclusion.- There are also three supporting studies which support the findings of the key study for 90 day and 28 day testing periods. Above the thresholds for classification no target organ toxicity was noted at gross necroscopy.Based on exposure considerations (to be presented in the CSR), and the toxicokinetic and physicochemical properties of the test substance it was considered to be scientifically justifiable to waive in vivo testing for inhalation and dermal repeat dose administration. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ffc1e3b8-a905-414e-8d09-e9d9655e95f5/documents/IUC5-ef80f894-9533-4d3a-a398-c1e042a4722f_17c5bef3-cea0-4cb7-a8d4-5f9e653239ac.html,,,,,, Trisodium trimetaphosphate,7785-84-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ffc1e3b8-a905-414e-8d09-e9d9655e95f5/documents/IUC5-ef80f894-9533-4d3a-a398-c1e042a4722f_17c5bef3-cea0-4cb7-a8d4-5f9e653239ac.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Trisodium trimetaphosphate,7785-84-4,"Acute oral toxicity: Three studies are available for the acute oral toxicity endpoint. All studies indicate that trisodium trimetaphosphate has a low potential for systemic toxicity following acute administration via the oral route. The key study (Bradshaw J, 2010) has been conducted to a current guideline (OECD 420) and according to GLP. The acute oral median dose (LD50) of trisodium trimetaphosphate in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP). This conclusion is supported by the additional data provided for this endpoint.Acute inhalation toxicity: One key study exists. The study (Griffiths D, 2012) is conducted under the conditions of GLP and in accordance with an appropriate guideline (OECD 436). This study has been assigned a Klimisch reliability of 1. The LC50 of trisodium trimetaphosphate in male and female Wistar strain rat was found to be > 5.09 mg/L (maximum attainable concentration) and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ffc1e3b8-a905-414e-8d09-e9d9655e95f5/documents/IUC5-8720bde2-9dd0-4cfb-97ec-3df60c450998_17c5bef3-cea0-4cb7-a8d4-5f9e653239ac.html,,,,,, "1,4-bis(butylamino)anthraquinone",17354-14-2," The lethal dose of the test material was above the maximum tested dose of 6400 mg/kg bw after single, oral gavage in the rat. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f4d99f0-d491-46a2-93ad-f75c16aa11dc/documents/IUC5-1f2bf03c-1893-4a23-8370-84bb80610d0b_7ac863be-127a-4b2f-a543-9612e6e3515b.html,,,,,, "1,4-bis(butylamino)anthraquinone",17354-14-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f4d99f0-d491-46a2-93ad-f75c16aa11dc/documents/IUC5-1f2bf03c-1893-4a23-8370-84bb80610d0b_7ac863be-127a-4b2f-a543-9612e6e3515b.html,,oral,LD50,"6,400 mg/kg bw",no adverse effect observed, "1,4-bis(butylamino)anthraquinone",17354-14-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f4d99f0-d491-46a2-93ad-f75c16aa11dc/documents/IUC5-1f2bf03c-1893-4a23-8370-84bb80610d0b_7ac863be-127a-4b2f-a543-9612e6e3515b.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "1,4-bis(butylamino)anthraquinone",17354-14-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f4d99f0-d491-46a2-93ad-f75c16aa11dc/documents/IUC5-1f2bf03c-1893-4a23-8370-84bb80610d0b_7ac863be-127a-4b2f-a543-9612e6e3515b.html,,inhalation,discriminating conc.,4 mg/m3,no adverse effect observed, 1-(2-methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol,85-83-6," Repeated dose toxicity: via oral route; The No Observed Adverse Effect level (NOAEL) for test chemical  is considered to be  in a dose range of 1000-2500 mg/Kg/day in redent for chronic study. Repeated inhalation study: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 1-(2-methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol ( 85-83-6) which is reported as 4.57E-012 mmHg at 25 C. Also considering the particle size distribution of the substance the majority of the particles was found to be in the size range of 150 to 10 micron which is much larger size range compared to the inhalable particulate matter .Thus, exposure to inhalable dust, mist and vapour of the chemical 1-(2-methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol is highly unlikely. Therefore this study is considered for waiver. Repeated dermal study; The acute toxicity value for 1-(2-methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol ( 85-83-6) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 1-(2-methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 1-(2-methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b4259de-e68e-402e-9ea7-78ba283051b2/documents/b40555b7-fe97-4611-af5c-a36519508f3e_3749e449-33bb-4087-adca-2d540c2b8247.html,,,,,, 1-(2-methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol,85-83-6,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b4259de-e68e-402e-9ea7-78ba283051b2/documents/b40555b7-fe97-4611-af5c-a36519508f3e_3749e449-33bb-4087-adca-2d540c2b8247.html,Chronic toxicity – systemic effects,oral,NOAEL,"2,500 mg/kg bw/day",,rat 1-(2-methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol,85-83-6," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is 3600 mg/kg bw. The study concluded that LD50 is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 4.57E-012 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b4259de-e68e-402e-9ea7-78ba283051b2/documents/abcc3dd5-8334-4b94-ad73-0e0457df27d4_3749e449-33bb-4087-adca-2d540c2b8247.html,,,,,, 1-(2-methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol,85-83-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b4259de-e68e-402e-9ea7-78ba283051b2/documents/abcc3dd5-8334-4b94-ad73-0e0457df27d4_3749e449-33bb-4087-adca-2d540c2b8247.html,,oral,LD50,"3,600 mg/kg bw",no adverse effect observed, 1-(2-methyl-4-(2-methylphenylazo)phenylazo)-2-naphthol,85-83-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b4259de-e68e-402e-9ea7-78ba283051b2/documents/abcc3dd5-8334-4b94-ad73-0e0457df27d4_3749e449-33bb-4087-adca-2d540c2b8247.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl]benzoxazole-5-sulphonamide,68427-35-0," Oral (Subacute): Under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) of the test material is at least 750 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e02e89ea-1839-4649-89ec-b01843b0826c/documents/940106e4-4d70-414f-a991-290210fd7207_5fdd3684-cc90-448d-89eb-cc00bbb44c21.html,,,,,, 2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl]benzoxazole-5-sulphonamide,68427-35-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e02e89ea-1839-4649-89ec-b01843b0826c/documents/940106e4-4d70-414f-a991-290210fd7207_5fdd3684-cc90-448d-89eb-cc00bbb44c21.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat 2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl]benzoxazole-5-sulphonamide,68427-35-0, The oral LD50 value in Wistar rats was established to exceed 2000 mg/kg body weight. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e02e89ea-1839-4649-89ec-b01843b0826c/documents/8d1f7e22-dd87-4f09-bd58-6c78f3bac975_5fdd3684-cc90-448d-89eb-cc00bbb44c21.html,,,,,, 2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl]benzoxazole-5-sulphonamide,68427-35-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e02e89ea-1839-4649-89ec-b01843b0826c/documents/8d1f7e22-dd87-4f09-bd58-6c78f3bac975_5fdd3684-cc90-448d-89eb-cc00bbb44c21.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one",6407-78-9," Acute oral toxicity:  Acute oral toxicity dose (LD50) for 4-[(E)-2-(2,4-dimethylphenyl)diazen-1-yl]-3-methyl-1-phenyl-4,5-dihydro-1H-pyrazol-5-one (CAS no: 6407-78-9) was predicted based on OECD QSAR toolbox 2906 mg/kg bw and different studies available on structurally similar read across substances 4,4'-(1E,1'E)-(3,3'-dichlorobiphenyl-4,4'-diyl)bis(diazene-2,1-diyl)bis(3-methyl-1-phenyl-1H-pyrazol-5(4H)-one) (CAS no: 3520-72-7) >5000 mg/kg bw and 3-methyl-1-phenyl-5-pyrazolone (CAS no: 89-25-8) > 2000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 4-[(E)-2-(2,4-dimethylphenyl)diazen-1-yl]-3-methyl-1-phenyl-4,5-dihydro-1H-pyrazol-5-one cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: 4-[(E)-2-(2,4-dimethylphenyl)diazen-1-yl]-3-methyl-1-phenyl-4,5-dihydro-1H-pyrazol-5-one (CAS no: 6407-78-9) has very low vapour pressure (4.23E-07 Pa at 25°C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c25e65e4-23bf-496b-aa36-3c9a5425b40d/documents/a0e6f2a4-cb15-45a0-bbc4-df9a3ad1d519_695ee2e9-8ef5-4a9d-888d-de5f9ed7f535.html,,,,,, "4-[(2,4-dimethylphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one",6407-78-9,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c25e65e4-23bf-496b-aa36-3c9a5425b40d/documents/a0e6f2a4-cb15-45a0-bbc4-df9a3ad1d519_695ee2e9-8ef5-4a9d-888d-de5f9ed7f535.html,,oral,LD50,"2,906 mg/kg bw",no adverse effect observed, "6-amino-2-(2,4-dimethylphenyl)-1H-benz[de]isoquinoline-1,3(2H)-dione",2478-20-8, The oral LD50 value in Wistar rats was established to exceed 2000 mg/kg body weight. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0585be6-a32e-4d29-b2ed-af0f796ab283/documents/23e862ba-d394-484c-844e-89085efbd381_ea668207-ba09-476e-88f2-17d85b2a16b1.html,,,,,, "6-amino-2-(2,4-dimethylphenyl)-1H-benz[de]isoquinoline-1,3(2H)-dione",2478-20-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0585be6-a32e-4d29-b2ed-af0f796ab283/documents/23e862ba-d394-484c-844e-89085efbd381_ea668207-ba09-476e-88f2-17d85b2a16b1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-aminonaphthalene-1,8-dicarboximide",1742-95-6,"1h-benz[de]isoquinoline-1,3(2h)-dione, 6-amino- was non toxic by oral and dermal route. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf727850-3228-42d1-94e5-a08cd675ac6a/documents/IUC5-a71600d8-310b-43cf-bea8-359b1ef32e72_af6f25ec-b0c8-478d-8ae8-922f19628d2e.html,,,,,, "4-aminonaphthalene-1,8-dicarboximide",1742-95-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf727850-3228-42d1-94e5-a08cd675ac6a/documents/IUC5-a71600d8-310b-43cf-bea8-359b1ef32e72_af6f25ec-b0c8-478d-8ae8-922f19628d2e.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "4-aminonaphthalene-1,8-dicarboximide",1742-95-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf727850-3228-42d1-94e5-a08cd675ac6a/documents/IUC5-a71600d8-310b-43cf-bea8-359b1ef32e72_af6f25ec-b0c8-478d-8ae8-922f19628d2e.html,,dermal,LD50,"4,938 mg/kg bw",no adverse effect observed, "Hexa-2,4-dienoic acid",110-44-1,"In short-term to subchronic oral studies, Sorbic Acid and Potassium Sorbate were pratically non-toxic in rats and dogs at concentrations up to 10 and 2% respectively . ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d6ee322f-1f87-4579-a8af-6f96813c015f/documents/IUC5-8968d6f3-7d92-4ee1-bc5b-11ab4f55a498_f8fe3f2e-c22f-4bad-8258-45f19b51245e.html,,,,,, "Hexa-2,4-dienoic acid",110-44-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d6ee322f-1f87-4579-a8af-6f96813c015f/documents/IUC5-8968d6f3-7d92-4ee1-bc5b-11ab4f55a498_f8fe3f2e-c22f-4bad-8258-45f19b51245e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"6,792 mg/kg bw/day",,rat "Hexa-2,4-dienoic acid",110-44-1,"Acute toxicity testing by any route (oral, inhalation, and dermal) demonstrate no evidence of toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6ee322f-1f87-4579-a8af-6f96813c015f/documents/IUC5-70d2c3d1-633d-4956-877c-98b7e2e0a608_f8fe3f2e-c22f-4bad-8258-45f19b51245e.html,,,,,, "Hexa-2,4-dienoic acid",110-44-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6ee322f-1f87-4579-a8af-6f96813c015f/documents/IUC5-70d2c3d1-633d-4956-877c-98b7e2e0a608_f8fe3f2e-c22f-4bad-8258-45f19b51245e.html,,oral,LD50,"10,500 mg/kg bw",no adverse effect observed, "Hexa-2,4-dienoic acid",110-44-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6ee322f-1f87-4579-a8af-6f96813c015f/documents/IUC5-70d2c3d1-633d-4956-877c-98b7e2e0a608_f8fe3f2e-c22f-4bad-8258-45f19b51245e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sorbitan, isooctadecanoate",71902-01-7,"Repeated dose toxicity: Oral NOAEL (rat, m/f): ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e88ff3f1-1f3c-4e33-96a1-7f436f3aa1b2/documents/IUC5-c361db84-348d-49a9-a650-d07a84056bc5_4b086a53-29f8-4339-b2d1-912b102c1b3b.html,,,,,, "Sorbitan, isooctadecanoate",71902-01-7,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bwAcute toxicity: Inhalation LC50 (rat, m/f): > 5.27 mg/L airNo reliable studies on acute dermal toxicity available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e88ff3f1-1f3c-4e33-96a1-7f436f3aa1b2/documents/IUC5-b572e756-5701-4485-bdf4-7c2d22255af4_4b086a53-29f8-4339-b2d1-912b102c1b3b.html,,,,,, Sorbitan palmitate,26266-57-9,"Repeated dose toxicity: Oral NOAEL (rat, m/f): ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2485340d-a578-4865-8197-65e93fedcf3d/documents/IUC5-f88b3756-9139-48ca-8ab5-9c6ac7d01394_6a776650-b8f0-43b5-99a3-9fd9538811b3.html,,,,,, Sorbitan palmitate,26266-57-9,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bwAcute toxicity: Inhalation LC50 (rat, m/f): > 5.27 mg/L airNo reliable studies on acute dermal toxicity available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2485340d-a578-4865-8197-65e93fedcf3d/documents/IUC5-c45b5d1f-6517-4bed-9e88-cfb6c3218b39_6a776650-b8f0-43b5-99a3-9fd9538811b3.html,,,,,, "Sorbitan, octanoate (2:3)",91844-53-0,"Repeated dose toxicity: Oral NOAEL (rat, m/f): ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d38daf8e-57a3-4fd6-93d0-7a1e328a862e/documents/IUC5-f15a22ce-159a-4da7-8b0e-0927e09a26b6_4859f3ce-5ca7-43d7-a4ce-72a15d258ae8.html,,,,,, "Sorbitan, octanoate (2:3)",91844-53-0,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bwAcute toxicity: Inhalation LC50 (rat, m/f): > 5.27 mg/L airNo reliable studies on acute dermal toxicity available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d38daf8e-57a3-4fd6-93d0-7a1e328a862e/documents/IUC5-b3eeaaf9-5d66-48c6-90f2-2e67fd3c1100_4859f3ce-5ca7-43d7-a4ce-72a15d258ae8.html,,,,,, "Sorbitan, (Z)-9-octadecenoate (2:3)",8007-43-0,"Repeated dose toxicity: Oral NOAEL (rat, m/f): ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1b9380e-4479-4fcc-8705-c0091d072b06/documents/IUC5-2818f793-c260-486e-8bf2-7e13d185f11e_a7f6b496-c05a-480f-b2e0-82dbee570bc8.html,,,,,, "Sorbitan, (Z)-9-octadecenoate (2:3)",8007-43-0,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bwAcute toxicity: Inhalation LC50 (rat, m/f): > 5.27 mg/L airNo reliable studies on acute dermal toxicity available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1b9380e-4479-4fcc-8705-c0091d072b06/documents/IUC5-e9caed42-ec1b-4ec0-b7af-002b6f0850d6_a7f6b496-c05a-480f-b2e0-82dbee570bc8.html,,,,,, Sorbitan stearate,1338-41-6,"Repeated dose toxicity: Oral NOAEL (rat, m/f): ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34dcfa6c-09c2-4d2a-8b52-4afc1533a994/documents/d3b4d6c0-3f6f-41a4-84b4-64d93ac85e0a_5201ecdd-ddb6-4189-ac10-0b67b53dc23e.html,,,,,, Sorbitan stearate,1338-41-6,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bwAcute toxicity: Inhalation LC50 (rat, m/f): > 5.27 mg/L airNo reliable studies on acute dermal toxicity available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34dcfa6c-09c2-4d2a-8b52-4afc1533a994/documents/ac780d43-7f0c-4a5e-8ed8-90387ccd2a84_5201ecdd-ddb6-4189-ac10-0b67b53dc23e.html,,,,,, Anhydro-D-glucitol trioleate,26266-58-0,"Repeated dose toxicity: Oral NOAEL (rat, m/f): ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bed06f75-6624-4100-901a-115d872aff05/documents/IUC5-c361db84-348d-49a9-a650-d07a84056bc5_ae0f5278-2a78-4a3d-8b06-774ee73dbb2a.html,,,,,, Anhydro-D-glucitol trioleate,26266-58-0,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bwAcute toxicity: Inhalation LC50 (rat, m/f): > 5.27 mg/L airNo reliable studies on acute dermal toxicity available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bed06f75-6624-4100-901a-115d872aff05/documents/IUC5-b572e756-5701-4485-bdf4-7c2d22255af4_ae0f5278-2a78-4a3d-8b06-774ee73dbb2a.html,,,,,, Sorbitan tristearate,26658-19-5,"Repeated dose toxicity: Oral NOAEL (rat, m/f): ≥ 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c46026c8-7277-414e-b0bf-8d9f31e1526f/documents/IUC5-372bd966-67b1-47f6-891c-9594e454a235_4b75c2a9-93d3-4ce3-bab4-d34d130e4ea1.html,,,,,, Sorbitan tristearate,26658-19-5,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bwAcute toxicity: Inhalation LC50 (rat, m/f): > 5.27 mg/L airNo reliable studies on acute dermal toxicity available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c46026c8-7277-414e-b0bf-8d9f31e1526f/documents/IUC5-e4daefb2-4931-4bca-b354-65bdee506046_4b75c2a9-93d3-4ce3-bab4-d34d130e4ea1.html,,,,,, "Glycerides, C16-18 and C18-unsatd. mono-, di and tri-",91744-20-6,"Studies on oral repeated dose toxicity were available for the following Category members (CAS No.): 73398-61-5, 8001-79-4, 91845 -19-1 and for medium- and long-chain triglyceride mixtures. All available studies resulted in oral NOAELs of 1000 mg/kg bw/d or greater than 1000 mg/kg bw/d.Studies on dermal repeated dose toxicity were available for the following Category member (CAS No.): 73398-61-5.A subacute (28 days) dermal NOAEL of 2000 mg/kg bw/d for rabbits was reported. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63bfb8fc-ec7c-4201-a7b5-eee66c39aa4b/documents/IUC5-62e3c794-fa3c-4442-8aab-7dd2eaf6380c_e003afb6-bfec-4f76-aff0-cce13e8c9211.html,,,,,, "Glycerides, C16-18 and C18-unsatd. mono-, di and tri-",91744-20-6,"All available acute toxicity studies within this Category showed that Fatty Acid Glycerides are non-toxic via the oral, dermal or inhalation exposure route. Studies on acute oral toxicity were available for the following members of this category (CAS No.): 31566-31-1, 67701-26-2, 67701-33-1, 73398-61-5, 8001-78-3, 85251-77-0, 91744-13-7 and medium and long chain triglycerols (Matulka, 2006). The acute oral LD50 for rats and mice in all studies was found to be greater than 2000 or 5000 mg/kg bw.Studies on acute dermal toxicity were available for the following members of this category (CAS No.): 91845-19-1, 620-67-7, 555-43-1.The acute dermal LD50 in rats in all studies was found to be greater than 2000 mg/kg bwOne study on acute inhalation toxicity was available for the following member of this category (CAS No.): 73398-61-5.No signs of systemic toxicity occured in male rats upon acute inhalation exposure to the maximum attainable concentration of Triglycerides, mixed decanoyl and octanoyl (CAS No.: 73398-61-5). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63bfb8fc-ec7c-4201-a7b5-eee66c39aa4b/documents/IUC5-ebc86b3b-bd18-49e6-8586-032bfc9b18b8_e003afb6-bfec-4f76-aff0-cce13e8c9211.html,,,,,, "Quaternary ammonium compounds, trimethylsoya alkyl, chlorides",61790-41-8,"Overall, considering the repeated dose studies with the read across substances (TMAC C and TMAB C16), the main critical effects associated with these substances were due to their corrosive properties. The systemic effects such as the reduction of body weight and food consumption were considered to be secondary compared to the corrosive properties of the substances. Therefore, in the absence of ‘true’ systemic effects and in line with the biocides assessment reports, the derivation of a systemic DNEL has been considered to be non-relevant and only a qualitative local risk assessment has been conducted for the test substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Due to some deficiencies in the study, the 90-day oral study has not been considered further for hazard and risk assessment. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): The test substance has been classified as corrosive (no threshold derived) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline compliant read across study ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98e30ab5-8bec-42d9-9b55-a0599a9b9f80/documents/8e3f98c1-98cd-4569-9ee5-9cbc7ec97432_26ebd8f3-815b-4cbc-8579-3af3bd29ab24.html,,,,,, "Quaternary ammonium compounds, trimethylsoya alkyl, chlorides",61790-41-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98e30ab5-8bec-42d9-9b55-a0599a9b9f80/documents/8e3f98c1-98cd-4569-9ee5-9cbc7ec97432_26ebd8f3-815b-4cbc-8579-3af3bd29ab24.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rabbit "Quaternary ammonium compounds, trimethylsoya alkyl, chlorides",61790-41-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98e30ab5-8bec-42d9-9b55-a0599a9b9f80/documents/8e3f98c1-98cd-4569-9ee5-9cbc7ec97432_26ebd8f3-815b-4cbc-8579-3af3bd29ab24.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40.3 mg/kg bw/day,,rat "Quaternary ammonium compounds, trimethylsoya alkyl, chlorides",61790-41-8,"Based on the results of the read across study, the oral LD50 value of the test substance is considered to be 630 mg a.i./kg bw in rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98e30ab5-8bec-42d9-9b55-a0599a9b9f80/documents/23c0d3d0-f5bf-43e3-b640-94aa7e1b20a1_26ebd8f3-815b-4cbc-8579-3af3bd29ab24.html,,,,,, "Quaternary ammonium compounds, trimethylsoya alkyl, chlorides",61790-41-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98e30ab5-8bec-42d9-9b55-a0599a9b9f80/documents/23c0d3d0-f5bf-43e3-b640-94aa7e1b20a1_26ebd8f3-815b-4cbc-8579-3af3bd29ab24.html,,oral,LD50,630 mg/kg bw,adverse effect observed, "2,6,10,15,19,23-hexamethyltetracosa-2,6,10,14,18,22-hexaene",111-02-4,NOAEL oral rat > 660 mg/Kg bw ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/90e872e6-9d6f-47a4-a8fd-acdecfc48a43/documents/IUC5-1c231134-607c-4828-ac73-36a686e4b7f1_c4a8d18d-b93a-4699-afd9-8aeeeb6fd9ff.html,,,,,, "2,6,10,15,19,23-hexamethyltetracosa-2,6,10,14,18,22-hexaene",111-02-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/90e872e6-9d6f-47a4-a8fd-acdecfc48a43/documents/IUC5-1c231134-607c-4828-ac73-36a686e4b7f1_c4a8d18d-b93a-4699-afd9-8aeeeb6fd9ff.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,660 mg/kg bw/day,,rat "2,6,10,15,19,23-hexamethyltetracosa-2,6,10,14,18,22-hexaene",111-02-4,LD50 Oral mice > 5000 mg/Kg bwLD50 Oral Inhalatory rat > 13800 mg/m3 ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90e872e6-9d6f-47a4-a8fd-acdecfc48a43/documents/IUC5-8b736cf6-5aad-4c2b-ba2b-d068173bdbe9_c4a8d18d-b93a-4699-afd9-8aeeeb6fd9ff.html,,,,,, "2,6,10,15,19,23-hexamethyltetracosa-2,6,10,14,18,22-hexaene",111-02-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90e872e6-9d6f-47a4-a8fd-acdecfc48a43/documents/IUC5-8b736cf6-5aad-4c2b-ba2b-d068173bdbe9_c4a8d18d-b93a-4699-afd9-8aeeeb6fd9ff.html,,oral,LD50,"50,000 mg/kg bw",no adverse effect observed, "2,6,10,15,19,23-hexamethyltetracosa-2,6,10,14,18,22-hexaene",111-02-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90e872e6-9d6f-47a4-a8fd-acdecfc48a43/documents/IUC5-8b736cf6-5aad-4c2b-ba2b-d068173bdbe9_c4a8d18d-b93a-4699-afd9-8aeeeb6fd9ff.html,,inhalation,LC50,"13,800 mg/m3",no adverse effect observed, Tin dichloride,7772-99-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dbd784f0-7102-4238-94b9-b359884e88ad/documents/IUC5-913582a1-a5aa-4da8-ba1f-c117e92a063d_219708d5-9ecd-4c4e-9d3e-5d31aca2da62.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,39 mg/kg bw/day,,rat Tin dichloride,7772-99-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): - Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): - ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbd784f0-7102-4238-94b9-b359884e88ad/documents/IUC5-568be676-c9ee-46cc-a479-5a42c3fbb66f_219708d5-9ecd-4c4e-9d3e-5d31aca2da62.html,,,,,, Tin dichloride,7772-99-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbd784f0-7102-4238-94b9-b359884e88ad/documents/IUC5-568be676-c9ee-46cc-a479-5a42c3fbb66f_219708d5-9ecd-4c4e-9d3e-5d31aca2da62.html,,oral,LD50,"1,910 mg/kg bw",adverse effect observed, Tin dichloride,7772-99-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbd784f0-7102-4238-94b9-b359884e88ad/documents/IUC5-568be676-c9ee-46cc-a479-5a42c3fbb66f_219708d5-9ecd-4c4e-9d3e-5d31aca2da62.html,,inhalation,LC50,1.5 mg/m3,adverse effect observed, Tin difluoride,7783-47-3," Reliable substance-specific data on acute oral toxicity for tin difluoride do not exist. However, based on the reported acute oral LD50 values for the read-across substance sodium fluoride in experimental animals and the assumption that the fluoride anion is determinant for acute oral toxicity (demonstrated by a comparison with the results of other Sn(II) substances), the acute oral toxicity can be extrapolated to tin difluoride, yielding a classification as acute toxic 3 if ingested. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c01af12-0d3b-4f06-9305-df109fdd6971/documents/IUC5-0ec13fb2-dfc1-47d4-bb41-923070d97d4a_987e9f66-e8b1-4773-8d42-bd444f125d76.html,,,,,, Tin difluoride,7783-47-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c01af12-0d3b-4f06-9305-df109fdd6971/documents/IUC5-0ec13fb2-dfc1-47d4-bb41-923070d97d4a_987e9f66-e8b1-4773-8d42-bd444f125d76.html,,oral,LD50,148.5 mg/kg bw,adverse effect observed, Tin difluoride,7783-47-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c01af12-0d3b-4f06-9305-df109fdd6971/documents/IUC5-0ec13fb2-dfc1-47d4-bb41-923070d97d4a_987e9f66-e8b1-4773-8d42-bd444f125d76.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Benzyldimethyl(octadecyl)ammonium chloride,122-19-0," Based on the effects observed in the 90-day read across study, the NOEL for the test substance, C18 ADBAC, can be considered to be at 1500 or 1250 ppm a.i. in males and females, respectively (i.e., corresponding to 50 and 45 mg a.i./kg bw/d, respectively). However, in line with the Biocides dossier on the read across substance, it can be concluded that there were no primary systemic effects observed in the repeated dose studies and all observed effects could be attributed to local gastrointestinal irritation/corrosion and consequent reduced food intake. Therefore, the derivation of a DNEL for systemic effects via oral or dermal route has been deemed inappropriate. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c778b2d7-19f4-47a4-9411-03d1a0653fd2/documents/ebb3b2f0-2969-40f1-a49d-b9ed72f37369_1d822676-9cd9-45e2-8f31-dd74e8cd8a4e.html,,,,,, Benzyldimethyl(octadecyl)ammonium chloride,122-19-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c778b2d7-19f4-47a4-9411-03d1a0653fd2/documents/ebb3b2f0-2969-40f1-a49d-b9ed72f37369_1d822676-9cd9-45e2-8f31-dd74e8cd8a4e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,45 mg/kg bw/day,,dog Benzyldimethyl(octadecyl)ammonium chloride,122-19-0," Based on the results the read across studies, the oral and dermal LD50 value of the test substance, C18 ADBAC is considered to be 397.5 mg/kg bw and 3412.5 mg/kg bw respectively. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c778b2d7-19f4-47a4-9411-03d1a0653fd2/documents/775419cf-496a-405d-b40f-1a2b048f422f_1d822676-9cd9-45e2-8f31-dd74e8cd8a4e.html,,,,,, Benzyldimethyl(octadecyl)ammonium chloride,122-19-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c778b2d7-19f4-47a4-9411-03d1a0653fd2/documents/775419cf-496a-405d-b40f-1a2b048f422f_1d822676-9cd9-45e2-8f31-dd74e8cd8a4e.html,,oral,LD50,397.5 mg/kg bw,adverse effect observed, Stearamide,124-26-5,"RA-S CAS 112-84-5, Oral (OECD 408): NOAEL (subchronic) >= 1000 mg/kg bw/day (male/female) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5168b7be-b273-4ff6-b3d3-72932ef6f974/documents/a505672b-00f3-4c0a-9c16-89053df59825_55567b4c-4f72-4c8b-ad37-47b08be9b4fb.html,,,,,, Stearamide,124-26-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5168b7be-b273-4ff6-b3d3-72932ef6f974/documents/a505672b-00f3-4c0a-9c16-89053df59825_55567b4c-4f72-4c8b-ad37-47b08be9b4fb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Stearamide,124-26-5,"RA-S Amides, C16-C18 (even numbered), OECD 423, oral rat: LD50cut-off 5000 mg/kg bw (ATC method)RA-S CAS 112-84-5, OECD 436, inhal. rat: LC50 >2.8 mg/L (ATC method) (highest feasible aerosol concentration with respirable MMAD)RA-S CAS 112-84-5, OECD 402 dermal rat: LD50 >2000 mg/kg bw (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5168b7be-b273-4ff6-b3d3-72932ef6f974/documents/2115d48a-ac17-4376-9bc8-1426e2a298dc_55567b4c-4f72-4c8b-ad37-47b08be9b4fb.html,,,,,, Stearamide,124-26-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5168b7be-b273-4ff6-b3d3-72932ef6f974/documents/2115d48a-ac17-4376-9bc8-1426e2a298dc_55567b4c-4f72-4c8b-ad37-47b08be9b4fb.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Stearamide,124-26-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5168b7be-b273-4ff6-b3d3-72932ef6f974/documents/2115d48a-ac17-4376-9bc8-1426e2a298dc_55567b4c-4f72-4c8b-ad37-47b08be9b4fb.html,,inhalation,LC50,> 2.8 mg/L,no adverse effect observed, N-[3-(dimethylamino)propyl]stearamide,7651-02-7," - Subacute (14 day dose-range finding study) repeated dose toxicity study oral (gavage), rat Crl:WI(Han)) m/f (similar to OECD TG 407, GLP), dose levels: 0, 50, 200, 500 mg/kg bw/d; no NOAEL derived from this dose range finding study - Subchronic (90 day) repeated dose toxicity study, dermal, rabbit (New Zealand White) m/f (similar to OECD TG 411 GLP), dose levels: 5, 200 mg/kg bw/d: NOAEL = 200 mg/kg bw/d ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22ec8c6d-7e0a-4e5d-ba2a-9dc85ae635cb/documents/IUC5-f6395cb9-efe3-4432-bc3b-31286eb6419d_b83eecb9-287e-47f5-869d-8ee902447647.html,,,,,, N-[3-(dimethylamino)propyl]stearamide,7651-02-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22ec8c6d-7e0a-4e5d-ba2a-9dc85ae635cb/documents/IUC5-f6395cb9-efe3-4432-bc3b-31286eb6419d_b83eecb9-287e-47f5-869d-8ee902447647.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,200 mg/kg bw/day,,other:rabbit; highest dose tested N-[3-(dimethylamino)propyl]stearamide,7651-02-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22ec8c6d-7e0a-4e5d-ba2a-9dc85ae635cb/documents/IUC5-f6395cb9-efe3-4432-bc3b-31286eb6419d_b83eecb9-287e-47f5-869d-8ee902447647.html,Repeated dose toxicity – local effects,dermal,LOAEL,5 ,adverse effect observed,rabbit N-[3-(dimethylamino)propyl]stearamide,7651-02-7," Acute oral toxicity: LD50 > 2000 mg/kg bw, OECD Guideline 423, GLP compliant Acute dermal toxicity: LD50 expected to be > 2000 mg/kg bw based on read-across Acute inhalation toxicity: not necessary due to exposure considerations ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22ec8c6d-7e0a-4e5d-ba2a-9dc85ae635cb/documents/IUC5-f8f87d8b-2ae5-4eb1-90ec-cef7672e23ca_b83eecb9-287e-47f5-869d-8ee902447647.html,,,,,, N-[3-(dimethylamino)propyl]stearamide,7651-02-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22ec8c6d-7e0a-4e5d-ba2a-9dc85ae635cb/documents/IUC5-f8f87d8b-2ae5-4eb1-90ec-cef7672e23ca_b83eecb9-287e-47f5-869d-8ee902447647.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Octadecylamine,124-30-1,"No data are available for the primary alkylamine octadecylamines with regard to repeated dose toxicity. However, the 28-day oral toxicity test with (Z)-octadec-9-enylamines (Genamin OL 100 D) can be used based on read-across principles. This approach is in line with the existing EU risk assessment on primary alkylamines. Groups of five male and female rats recieved the test item by oral gavage at dose levels of 0, 3.25, 12.5 or 50 mg/kg body weight per day for a period of 28 days. At a dose of 50 mg/kg body weight per day clinical signs such as gait abnormalities, reduction in body weight gain and clinical pthology findings indicating mild toxic effects on the liver and kidneys were found. Effects observed at the mid-dose level (12.5 mg/kg) were slight reduction in growth. At the low dose group of 3.25 mg/kg body weight per day no effects were observed. Hence, the NOAEL of this study was placed at 3.25 mg/kg body weight per day. In accordance with the existing EU risk assessment on primary alkylamines, this value is considered to be valid also for octadecylamines and will be used for all relevant exposures by route-to-route extrapolation for this category of chemicals. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/779ad66c-42a0-4140-b6e6-3fce284d93ec/documents/56816748-6416-4fd8-b19a-6a5af1ff87f0_4bb77a29-2c44-4b02-b616-3075721b28a4.html,,,,,, Octadecylamine,124-30-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/779ad66c-42a0-4140-b6e6-3fce284d93ec/documents/56816748-6416-4fd8-b19a-6a5af1ff87f0_4bb77a29-2c44-4b02-b616-3075721b28a4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,3.25 mg/kg bw/day,,rat Octadecylamine,124-30-1,"The test material Genamin 18R 100D (octadecylamines) was tested for acute oral toxicity in a GLP compliant study according to OECD test guideline 401. The test item was applied via gavage to Wistar rats in a limit test at 2000 mg/kg body weight in sesame oil as vehicle. Clinical signs following treatment included irregular breathing and reduced spontaneous activity. An impairement of body weight development was not observed. Macroscopic findings of toxicological significance were not observed at gross pathology. The LD50 was greater 2000 mg/kg body weight. With regard to acute dermal toxicity, a LD50 value of greater 2000 mg/kg body weight from a guideline conform study on C12-18-(even numbered)-alkylamines can be assumed based on read-across. Data from an inhalation study with C12-18-(even numbered)-alkylamines indicate a 1hour LC50 greater 0.099 mg/L and will be used as read-across. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/779ad66c-42a0-4140-b6e6-3fce284d93ec/documents/d95768fb-2318-47d9-90d5-29840c1c4484_4bb77a29-2c44-4b02-b616-3075721b28a4.html,,,,,, Octadecylamine,124-30-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/779ad66c-42a0-4140-b6e6-3fce284d93ec/documents/d95768fb-2318-47d9-90d5-29840c1c4484_4bb77a29-2c44-4b02-b616-3075721b28a4.html,,oral,LD50,"2,000 mg/kg bw",, Octadecylamine,124-30-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/779ad66c-42a0-4140-b6e6-3fce284d93ec/documents/d95768fb-2318-47d9-90d5-29840c1c4484_4bb77a29-2c44-4b02-b616-3075721b28a4.html,,dermal,LD50,"2,000 mg/kg bw",, "N,N-dimethyloctadecylamine N-oxide",2571-88-2," As indicated in the read-across justification, data from Amine oxide can be used for read-across to N,N-Dimethyl-1-octadecanamine-N-oxide (CAS 2571-88-2 / EINECS 219-919-5) acute oral toxicity. Concerning the read-across approach, the data on the other C18 Amine Oxide (Dihydroxyethyl oleamine oxide - CAS 93962-62-0) was used to determine the LD50 of N,N-Dimethyl-1-octadecanamine-N-oxide : The LD50 female rat is 1 706 mg/kgbw  The LD50 male rat is 7 489 mg/kgbw And  N,N-Dimethyl-1-octadecanamine-N-oxide is considered as Oral Acute Tox, H302 based on the effect on the female rat. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b1fdde0-210c-4a90-a201-c70d3890ff34/documents/b9c2b149-7a00-44fe-be1b-852f4653de42_47cd113b-1924-4c8d-8c3a-e391b46ae510.html,,,,,, "N,N-dimethyloctadecylamine N-oxide",2571-88-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b1fdde0-210c-4a90-a201-c70d3890ff34/documents/b9c2b149-7a00-44fe-be1b-852f4653de42_47cd113b-1924-4c8d-8c3a-e391b46ae510.html,,oral,LD50,"1,706 mg/kg bw",adverse effect observed, "Octadecan-1-ol, ethoxylated",9005-00-9," Oral (subacute, rat, m/f, OECD 422): NOAEL (systemic toxicity) = 1000 mg/kg bw/day Oral (subacute, rat, m/f, OECD 422): NOAEL (local toxicity) = 300 mg/kg bw/day Oral (subchronic, rat, m/f, OECD 408): NOAEL (systemic toxicity) = 300 mg/kg bw/day Oral (subchronic, rat, m/f, OECD 408): NOAEL (local toxicity) = 1000 mg/kg bw/day   Read-across based on grouping of substances (category approach) considering all the available data on repeated dose toxicity in the AE category, in a Weight-of-Evidence approach. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8a3872c-2160-46f2-a01b-d660a038f1e4/documents/47c76450-4588-4291-aa16-fedc9c948176_8b2491e4-d9b3-4ec9-8a94-ca04fba4c24c.html,,,,,, "Octadecan-1-ol, ethoxylated",9005-00-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8a3872c-2160-46f2-a01b-d660a038f1e4/documents/47c76450-4588-4291-aa16-fedc9c948176_8b2491e4-d9b3-4ec9-8a94-ca04fba4c24c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Octadecan-1-ol, ethoxylated",9005-00-9," Oral (rat, m/f, OECD 401): LD50 > 21000 mg/kg bw Conclusion based on data obtained with octadecan-1-ol, ethoxylated (CAS No. 9005-00-9, EC No. 500-017-8) and considering all available data on acute toxicity in the Alcohol Ethoxylates (AE) category in a Weight-of-Evidence approach. Inhalation: No study required as the inhalation route of exposure is considered less relevant than the dermal route for AE substances. Dermal: According to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, no study is required as the AE substances do not meet the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8a3872c-2160-46f2-a01b-d660a038f1e4/documents/8505f9a3-a571-4424-97f9-f7e8aa69a7c8_8b2491e4-d9b3-4ec9-8a94-ca04fba4c24c.html,,,,,, "Octadecan-1-ol, ethoxylated",9005-00-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8a3872c-2160-46f2-a01b-d660a038f1e4/documents/8505f9a3-a571-4424-97f9-f7e8aa69a7c8_8b2491e4-d9b3-4ec9-8a94-ca04fba4c24c.html,,oral,LD50,"> 21,000 mg/kg bw",no adverse effect observed, "Octadecan-1-ol, ethoxylated, phosphates",62362-49-6," Repeat dose toxicity Oral administration of the test item to parental Han Wistar rats at dose levels of 100, 330 or 1000 mg/kg/day for five weeks to males and for two weeks before pairing, throughout gestation and up to Day 13 of lactation in females was well-tolerated in the adult animals with no treatment related adverse effects observed.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f67fb77b-407c-4969-a00c-d0307f22566c/documents/7a7fb0a2-610e-45c1-b575-2ddd43e15e68_c9535504-eeab-4300-b0f0-18d519604ddd.html,,,,,, "Octadecan-1-ol, ethoxylated, phosphates",62362-49-6," Acute toxicity: Oral Under the conditions of the study, the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System: Unclassified). The acute dermal and inhalation toxicity studies were waived as exposure via these routes is not expected. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f67fb77b-407c-4969-a00c-d0307f22566c/documents/06c1d7da-22e1-49e4-8d89-78e4b62edfaa_c9535504-eeab-4300-b0f0-18d519604ddd.html,,,,,, Stearic acid,57-11-4,"Reliable studies on oral repeated dose toxicity are available for the following category members:Subchronic: NOAEL oral = ca. 5000 mg/kg bw/d; CAS# 143-07-7, C12 (Fitzhugh 1960)Subchronic: NOAEL oral = 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao 2002)No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/499cb8e5-b4a3-4ec8-9a1c-9dc50075234a/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_f30ef346-29f0-4bc4-9af1-b4e9b9f44a6e.html,,,,,, Stearic acid,57-11-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/499cb8e5-b4a3-4ec8-9a1c-9dc50075234a/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_f30ef346-29f0-4bc4-9af1-b4e9b9f44a6e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Stearic acid,57-11-4,Acute toxicity:- oral: LD50 >6000 mg/kg bw (OECD 401);- inhalative: LC50 >0.1521 mg/L (IHT; Analogy CAS 124-07-2); - dermal: LD50 >2000 mg/kg bw; ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/499cb8e5-b4a3-4ec8-9a1c-9dc50075234a/documents/IUC5-5b79f76e-0c56-45f5-b6d1-c629a94a5865_f30ef346-29f0-4bc4-9af1-b4e9b9f44a6e.html,,,,,, Pentatriacontan-18-one,504-53-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6927a70c-98f3-4d01-ab48-d19a01d8c171/documents/48e54692-78d1-4ba9-b6d2-ce38e820e552_de32fd9d-adeb-4252-b8f4-8226b2fe4e2b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Trimethyloctadecylammonium bromide,1120-02-1, LD50 in a range of 300 - 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5bc4acf-daa7-4214-989a-ad5b25c9213c/documents/0be2e2f2-e55c-4677-af36-bf9209b3cdff_084bd55e-39b8-44f8-a095-23fae9f5f36b.html,,,,,, Trimethyloctadecylammonium bromide,1120-02-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5bc4acf-daa7-4214-989a-ad5b25c9213c/documents/0be2e2f2-e55c-4677-af36-bf9209b3cdff_084bd55e-39b8-44f8-a095-23fae9f5f36b.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Trimethyloctadecylammonium chloride,112-03-8," Overall, considering the repeated dose studies with the read across substances (e.g., Coco TMAC, C16 TMAC), the main critical effects associated with these substances were due to their corrosive properties. The systemic effects such as the reduction of body weight and food consumption were considered to be secondary compared to the corrosive properties of the substances. Therefore, in the absence of ‘true’ systemic effects and in line with the biocides assessment reports, the derivation of a systemic DNEL has been considered to be non-relevant and only a qualitative local risk assessment has been conducted for the test substance.  ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30c06b34-4034-42ac-9f57-d941e32e01bf/documents/cfd3de56-df54-4b31-8890-43136201a871_e4935796-5666-4eea-aaa2-f686d8c9996c.html,,,,,, Trimethyloctadecylammonium chloride,112-03-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30c06b34-4034-42ac-9f57-d941e32e01bf/documents/cfd3de56-df54-4b31-8890-43136201a871_e4935796-5666-4eea-aaa2-f686d8c9996c.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rabbit Trimethyloctadecylammonium chloride,112-03-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30c06b34-4034-42ac-9f57-d941e32e01bf/documents/cfd3de56-df54-4b31-8890-43136201a871_e4935796-5666-4eea-aaa2-f686d8c9996c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40.3 mg/kg bw/day,,rat Trimethyloctadecylammonium chloride,112-03-8," The oral LD50 value of the test substance was determined to be 560 mg a.i./kg bw in rats, suggesting a moderate acute toxicity potential. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30c06b34-4034-42ac-9f57-d941e32e01bf/documents/415d48fd-268a-463b-9656-61fcfa29099c_e4935796-5666-4eea-aaa2-f686d8c9996c.html,,,,,, Trimethyloctadecylammonium chloride,112-03-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30c06b34-4034-42ac-9f57-d941e32e01bf/documents/415d48fd-268a-463b-9656-61fcfa29099c_e4935796-5666-4eea-aaa2-f686d8c9996c.html,,oral,LD50,560.5 mg/kg bw,adverse effect observed, Octadecyl acrylate,4813-57-4,"Oral  In two combined repeated oral dose and reproductive / developmental toxicity screening studies (OECD 422) in rats the structural analogues 2-Propenoic acid, C12-14-alkyl esters and 2-Propenoic acid, C18-22-alkyl esters showed no toxicity up to the highest administered dose of 1000 mg/kg bw/day (see table 1).  Table 1. Data on repeated oral dose toxicity     Ester   Method   Species   NOAEL   Reference 2-Propenoic acid, C12-14- alkyl esters     OECD TG 422   Rats   1000 mg/kg bw/day (highest dose tested)   BASF SE 2013 2-Propenoic acid, C18-22- alkyl esters     OECD TG 422   Rats   1000 mg/kg bw/day (highest dose tested) BASF SE 2013 The available data from the group of long-chain acrylate esters for repeated dose toxicity cover the shortest and longest chain lengths present in the category. Within both studies the NOAEL was 1000 mg/kg bw/d the highest dose tested and the limit dose for this kind of study.  The long-chain alky acrylates have a decreasing bioavailability with increasing chain length. As described in the chapter 7.1. Toxicokinetics in silico and in vitro studies were performed to address this.  A PBPK model using The Simcyp Animal Simulator Version 22 Release 1 (Certara UK, Hartley, 2023)) was used for PBPK simulations of ethyl acrylate, 2-ethylhexyl acrylate, dodecyl acrylate, tetradecyl acrylate, hexadecyl acrylate, octadecyl acrylate, Icosyl acrylate and docosyl acrylate. A whole body PBPK model, which allows for the addition of further specific organs, or a minimal PBPK model was used in simulations. The expected low gastrointestinal and systemic uptake was confirmed in this in silico PBPK modelling. For dodecyl acrylate, tetradecyl acrylate, hexadecyl acrylate, octadecyl acrylate; icosyl acrylate and docosyl acrylate the predicted fraction absorbed was 0.81, 0.71, 0.015, 0.0001, 0.0022, and 0.0006, respectively. In addition, an in vitro intestinal absorption test with acrylates in the EpiIntestinal model was performed with dodecyl acrylate, hexadecyl acrylate, octadecyl acrylate and docosyl acrylate (BASF SE, 2024). The results of this in vitro intestinal absorption test (EpiIntestinal model) indicate that none of the four compounds (dodecyl acrylate , hexadecyl acrylate, octadecyl acrylate and docosyl acrylate) crosses the intestinal barrier. Based on the results regarding the hydrolysis and metabolism of the compounds to the corresponding alcohols, we identified a considerable transfer of 1-dodecanol (6.3%) and a marginal transfer of 1-hexadecanol (0.4%) to the receptor chamber, indicating that hydrolysis products of short chain acrylates might cross the intestinal barrier. In the in vitro intestinal absorption test the concentration of dodecyl acrylate of 5 mM (limited by cytotoxicity in higher concentrations) equates to a dose of 509.6 mg/kg BW, the concentration of hexadecyl acrylate, octadecyl acrylate and docosyl acrylate of 100 mM equates to doses of 12572, 13760 and 16140 mg/kg BW, respectively, which markedly exceeds the in vivo limit dose of 1000 mg/kg BW (repeated dose toxicity / reproduction toxicity). Taken together, it can be postulate that under realistic exposure scenarios no physiologically relevant uptake of the long-chain alkyl acrylates occurs. Based on this data it can be expected that dodecyl acrylate, the category member with the shortest alkyl chain has a low likelihood to be bioavailable after oral uptake. Whereas for the other category members the bioavailiability after oral uptake can be regarded to be negligible. Therefore, the registrant proposes to perform a subchronic study, according to OECD TG 408 with dodedyl acrylate to support the data requirements according to REACH Annex IX. In addition, a repeated oral dose and reproductive / developmental toxicity screening studies according to OECD TG 422 is ongoing with hexadecyl acrylate to support the hypothesis.   Inhalation  The inhalation route is not of relevance due to the very low vapour pressure of the substances (see chapter on Toxicokinetics).  Dermal  The experimental repeated dose oral toxicity data demonstrated in accordance with acute dermal and oral tests the low toxicity of the long-chain alkyl esters. In addition, the characteristics of skin penetration and metabolism in the skin show the limited bioavailability of the esters via the dermal route (see chapter on Toxicokinetics). Therefore, the potential for repeated dermal dose toxicity can be considered low.  Conclusion  In conclusion, the long-chain alkyl acrylate esters (C12 – C22) showed no oral toxicity after repeated application. Studies available are considered to be reliable and suitable to cover the endpoint repeated dose toxicity and fulfil the REACH information requirements of Annex VIII / IX, section 8.6.  The variable part of the category approach is the length and/or configuration of the side chain of the parent ester and the alcohol metabolite, as well as their impacts on physico-chemical properties and consequent biological properties. Despite these variations, the available data support a lack of systemic toxicity for all the category members, since data is availablefor the shortest and longest chain lengths present in the category. These repeated dose toxicity studies have also reported a similar and common profile of target organs (i.e. a lack of systemic toxicity). Thus, the results of the collection of these studies conducted on these substances are consistent and can be regarded as offering a true picture of repeated dose toxicity for the category. In order to fill the data-gap for the mono-constituents, a category based read-across is applied to the repeated dose toxicity studies available for oral route. Overall, the read-across approach is applied with a high level of confidence.    Therefore, the registrant proposes to perform a subchronic study, according to OECD TG 408 with dodedyl acrylate to support the data requirements according to REACH Annex IX. In addition, a repeated oral dose and reproductive / developmental toxicity screening studies according to OECD TG 422 is ongoing with hexadecyl acrylate to support the hypothesis of negligible bioavailability. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5fd1f959-b91b-4d82-934e-d9cd822fb031/documents/0e20e56c-f4ac-41e9-92dc-4650e6c81fd9_d6e7bd7d-5820-4e68-b435-42110c138b92.html,,,,,, Octadecyl acrylate,4813-57-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5fd1f959-b91b-4d82-934e-d9cd822fb031/documents/0e20e56c-f4ac-41e9-92dc-4650e6c81fd9_d6e7bd7d-5820-4e68-b435-42110c138b92.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Octadecyl acrylate,4813-57-4,"Three oral toxicity studies conducted with mixtures of long-chain acrylate esters and one study with octadecyl acrylate (C18) showed no acute toxicity after oral exposure (see table 1).   Table 1 . Acute oral toxicity data from the source substances    Ester   Method   Species   LD50   Reference 2-Propenoic acid, C16-18-alkyl esters     OECD TG 423   Rats   > 2000 mg/kg bw   BASF SE 2012 Octadecyl acrylate   EU B.1 Rats > 5000 mg/kg bw BASF SE 1985 2-Propenoic acid, C18-22-alkyl esters     OECD TG 423   Rats   > 2000 mg/kg bw   BASF SE 2012 2-Propenoic acid, C12-14-alkyl esters   OECD TG 401 Rats > 5570 mg/kg bw BASF AG 1964 The available data from the group of long-chain acrylate esters for the oral route cover all chain lengths present in the category. They are consistent and sufficient to enable an assessment for this endpoint.  Inhalation  The inhalation route is not of relevance due to the low vapour pressure of the substances (see chapter on Toxicokinetics).  Dermal  Three dermal toxicity studies conducted with mixtures of long-chain acrylate esters showed no acute toxicity after dermal application (see table 2 ).  Table 2 . Acute dermal toxicity data from the source substances  Ester Method Species LD50 Reference 2-Propenoic acid, C12-14-alkyl esters   OECD TG 402 Rat > 5000 mg/kg bw BASF SE 2012 2-Propenoic acid, C16-18-alkyl esters       OECD TG 402     Rat     > 5000 mg/kg bw     BASF SE 2012 2-Propenoic acid, C18-22-alkyl esters   OECD TG 402 Rat > 5000 mg/kg bw BASF SE 2012 The available data from the group of long-chain acrylate esters for the dermal route cover all chain lengths present in the category. They are consistent and sufficient to enable an assessment for this endpoint.    ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fd1f959-b91b-4d82-934e-d9cd822fb031/documents/e236c7fb-9be7-49f9-a37a-743907241192_d6e7bd7d-5820-4e68-b435-42110c138b92.html,,,,,, Octadecyl acrylate,4813-57-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fd1f959-b91b-4d82-934e-d9cd822fb031/documents/e236c7fb-9be7-49f9-a37a-743907241192_d6e7bd7d-5820-4e68-b435-42110c138b92.html,,oral,discriminating dose,"5,570 mg/kg bw",no adverse effect observed, Octadecyl acrylate,4813-57-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fd1f959-b91b-4d82-934e-d9cd822fb031/documents/e236c7fb-9be7-49f9-a37a-743907241192_d6e7bd7d-5820-4e68-b435-42110c138b92.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Octadecyl acrylate,4813-57-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fd1f959-b91b-4d82-934e-d9cd822fb031/documents/e236c7fb-9be7-49f9-a37a-743907241192_d6e7bd7d-5820-4e68-b435-42110c138b92.html,,inhalation,discriminating conc.,690 mg/m3,no adverse effect observed, Octadecan-1-ol,112-92-5,"  In the key study, no adverse effects were seen after dietary administration of a reliable 13 week oral feeding study in rats using hexadecan-1-ol reported a NOAEL value of >4400 mg/kg bw. (Scientific Assoc, 1966a; rel. 2) In addition read across from a reliable 28 day oral gavage study in rats using octadecan-1-ol reported a NOAEL value of >1000 mg/kg bw (Henkel, 1985a; rel. 2). A four week reliable oral study in rats using octadecan-1-ol reported a NOAEL value of 1000 mg/kg bw, the highest dose tested (Henkel, 1986a; rel. 1). A reliable 26 week oral gavage study in rats using docosan-1-ol reported no adverse effects at the highest dose tested, 1000 mg/kg bw (Iglesias et al., 2002a). Further supporting data come from a 90 day feeding study in rats with of Alcohols, C14-15-branched and linear (Ito et al., 1978) which reported a NOAEL value of >3548 mg/kg bw/day. A read across from a reliable 13 week dietary study in rats using hexan-1-ol reported a NOAEL of 1127 mg/kg (Scientific Associates Inc., 1966). No adverse effects were noted at any of the dose levels administered during the study.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b8dcaa3-6664-4549-83f1-0a14cc501b7c/documents/f2e734c3-bc0f-4cee-b7da-e6cc5ef803aa_4191f8fd-22af-410c-88fe-4f71d3642f52.html,,,,,, Octadecan-1-ol,112-92-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b8dcaa3-6664-4549-83f1-0a14cc501b7c/documents/f2e734c3-bc0f-4cee-b7da-e6cc5ef803aa_4191f8fd-22af-410c-88fe-4f71d3642f52.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"4,412 mg/kg bw/day",,rat Octadecan-1-ol,112-92-5," The key study for acute oral toxicity, conducted according to OECD TG 401, and in compliance with GLP, reports an LD50 value of >2000 mg/kg in rat (Safepharm Laboratories, 1991, rel 1). No information was available for the acute inhalation endpoint. However, further testing is not scientifically justified since high reliability data is in place for acute toxicity via the oral and dermal routes. Furthermore, weight of evidence across category suggests that the LC50 for inhalation is expected to be greater than the substantially saturated vapour concentration. The key acute dermal toxicity study was read-across from structurally analogous substance tetradecan-1-ol (CAS 112-72-1). The study was well documented and met generally accepted scientific principles, but was not compliant with GLP, reports an LD50 value of 8000 mg/kg in rabbit (Scientific Associates 1977; rel 2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b8dcaa3-6664-4549-83f1-0a14cc501b7c/documents/7f6f9d5b-48d4-4ab4-a5a6-2954918cebac_4191f8fd-22af-410c-88fe-4f71d3642f52.html,,,,,, Octadecan-1-ol,112-92-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b8dcaa3-6664-4549-83f1-0a14cc501b7c/documents/7f6f9d5b-48d4-4ab4-a5a6-2954918cebac_4191f8fd-22af-410c-88fe-4f71d3642f52.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Octadecan-1-ol,112-92-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b8dcaa3-6664-4549-83f1-0a14cc501b7c/documents/7f6f9d5b-48d4-4ab4-a5a6-2954918cebac_4191f8fd-22af-410c-88fe-4f71d3642f52.html,,dermal,LD50,"8,000 mg/kg bw",no adverse effect observed, (Z)-N-octadecyldocos-13-enamide,10094-45-8," NOAEL (OECD 422, oral, rat): >= 1000 mg/kg bw/day NOAEL (OECD 408, oral, rat): >= 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/341ddef5-526f-4831-ba8d-4936513ea524/documents/5ebe18e9-da0e-4e1f-91d8-50f34a83617f_429f58b8-4ac8-484f-a42e-afc1b288d60e.html,,,,,, (Z)-N-octadecyldocos-13-enamide,10094-45-8," Oral: RA-A CAS 16260-09-6 and CAS 13276-08-9, OECD 401, rat: LD50 > 2400 mg/kg bw Dermal: RA-A CAS 16260-09-6, OECD 402, rat: LD50 > 2000 mg/kg bw Inhalation: no study available ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/341ddef5-526f-4831-ba8d-4936513ea524/documents/ca3e2b93-3a30-409f-97ce-1cc4c221ae24_429f58b8-4ac8-484f-a42e-afc1b288d60e.html,,,,,, Octadecyl methacrylate,32360-05-7,"Subacute study; oral (gavage); rat (Sprague Dawley SD), m/f (OECD guideline 422, Klimisch score: 1,GLP), no toxicity occurred up to the highest administered dose of 1000 mg/kg/day with the structural analogue dodecyl methacrylate: NOAEL = 1000 mg/kg bw/d (CIT, 2007).With regard to the low repeated dose oral toxicity and the characteristics of skin penetration and metabolism in the skin, the repeated dose dermal toxicity can be considered as low. The inhalation route is not of relevance due to the very low vapour pressure of the substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca372b14-ca4c-44c7-9d7a-19f0fd29af8e/documents/IUC5-0afe211d-da6b-4380-87aa-01b8b4fcdbbd_626e0ffb-968f-47d4-b504-78378daba36d.html,,,,,, Octadecyl methacrylate,32360-05-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca372b14-ca4c-44c7-9d7a-19f0fd29af8e/documents/IUC5-0afe211d-da6b-4380-87aa-01b8b4fcdbbd_626e0ffb-968f-47d4-b504-78378daba36d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Octadecyl methacrylate,32360-05-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): There is one relevant, adequate and reliable study with structural analogue dodecyl methacrylate available (FHG, 1988) (Klimisch score = 1) The test was performed in accordance with generally accepted scientific standards and described in sufficient detail. Guideline study OECD 401, GLP. This result is supported by three other acute oral toxicity studies with structuraly analogue long chain alkyl methacrylate esters (C12 -C22) with LD50 values above 5000 mg/kg. These results indicate a very low toxic potential of the long-chain alkyl methacrylate esters (C12 – C22). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Inhalation is no relevant route of exposure and testing by inhalation is not appropriate. Exposure of humans via inhalation is unlikely taking into account the low vapour pressure and the low possibility of exposure to aerosols, particles or droplets of an inhalable size. Furthermore no reliable data are available on long-chain methacrylate esters (C12 – C22) for the inhalation route. However, data are available on the structural analogues substances: methyl-, ethyl- and n-butyl methacrylate. The respective LC50 values are in a range between 5000 and 11000 ppm indicating low inhalation toxicity. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): In a dermal acute toxicity study on isodecyl methacrylate (structurally related substance of tetradecyl methacrylate) with albino rabbits an LD50 > 3000 mg/kg was determined. Reliable study according to generally accepted scientific standards and decribed in sufficient detail. This experimentally observed result is supported by a dermal toxicity study with structural analogue dodecyl pentadecyl methacrylate where a LD50: > 5000 mg/kg, dermal, rabbit was observed (Rohm & Haas, 1975). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca372b14-ca4c-44c7-9d7a-19f0fd29af8e/documents/IUC5-fb8d9140-f71f-4810-a511-0bbe174b77a6_626e0ffb-968f-47d4-b504-78378daba36d.html,,,,,, Octadecyl methacrylate,32360-05-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca372b14-ca4c-44c7-9d7a-19f0fd29af8e/documents/IUC5-fb8d9140-f71f-4810-a511-0bbe174b77a6_626e0ffb-968f-47d4-b504-78378daba36d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Octadecyl methacrylate,32360-05-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca372b14-ca4c-44c7-9d7a-19f0fd29af8e/documents/IUC5-fb8d9140-f71f-4810-a511-0bbe174b77a6_626e0ffb-968f-47d4-b504-78378daba36d.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, Octadecyl stearate,2778-96-3," Repeated dose toxicity: Oral The No Observed Adverse Effect Level (NOAEL) of the test chemical in the rat via oral route of exposure is considered to be 1000 mg/kg body weight in male and female animals.   Repeated dose toxicity: Inhalation Test chemical has very low vapor pressure of 2.16E-09 Pa. (1.62013e-11 mm Hg), so the potential for the generation of inhalable vapours is very low, also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route of exposure was considered for waiver.   Repeated dose toxicity: Dermal The acute dermal toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/affde1a4-81e2-4cc8-8c8d-d9ffb4e57d15/documents/0a88525c-f55c-49be-bcfa-8b1aeeba5b61_d5731bdb-fd52-407e-9cb0-deb1248d92e6.html,,,,,, Octadecyl stearate,2778-96-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/affde1a4-81e2-4cc8-8c8d-d9ffb4e57d15/documents/0a88525c-f55c-49be-bcfa-8b1aeeba5b61_d5731bdb-fd52-407e-9cb0-deb1248d92e6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Octadecyl stearate,2778-96-3," Acute oral Toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is >2500 mg/kg bw. The study concluded that LD50 is >2000 mg/kg bw for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity:  Test chemical has very low vapour pressure (2.16E-09 Pa. = 1.620133003827e-11 mmHg),So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver. Acute dermal Toxicity:  The acute dermal toxicity dose (LD50) for test chemical was based on data available for the test chemicals. The LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,test chemical cannot be classified for acute dermal toxicity.  ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/affde1a4-81e2-4cc8-8c8d-d9ffb4e57d15/documents/fb4aac9e-7496-4b70-9212-4a13cc1286b0_d5731bdb-fd52-407e-9cb0-deb1248d92e6.html,,,,,, Octadecyl stearate,2778-96-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/affde1a4-81e2-4cc8-8c8d-d9ffb4e57d15/documents/fb4aac9e-7496-4b70-9212-4a13cc1286b0_d5731bdb-fd52-407e-9cb0-deb1248d92e6.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Octadecyl stearate,2778-96-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/affde1a4-81e2-4cc8-8c8d-d9ffb4e57d15/documents/fb4aac9e-7496-4b70-9212-4a13cc1286b0_d5731bdb-fd52-407e-9cb0-deb1248d92e6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Strontium di(acetate),543-94-2," A study on SrCl2, a structural analogue was used in a read-across approach. If the increased concentrations of strontium in the bone can be considered a non-toxic effect, a NOAEL of 300 ppm SrCl2 can be derived form this study which is based on the weight changes of thyroids at the doses of 1200 ppm (LOAEL) and 4800 ppm. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25735728-8c65-4cfe-9bf0-0cf7f978d45d/documents/990bba36-bfa2-4c18-b53d-9f4159a508d9_79ff16e3-929d-4e42-9084-caa3f0a117ad.html,,,,,, Strontium di(acetate),543-94-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25735728-8c65-4cfe-9bf0-0cf7f978d45d/documents/990bba36-bfa2-4c18-b53d-9f4159a508d9_79ff16e3-929d-4e42-9084-caa3f0a117ad.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Strontium di(acetate),543-94-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25735728-8c65-4cfe-9bf0-0cf7f978d45d/documents/ac5c9439-04ea-43db-9eec-8536b8948c2a_79ff16e3-929d-4e42-9084-caa3f0a117ad.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Strontium di(acetate),543-94-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25735728-8c65-4cfe-9bf0-0cf7f978d45d/documents/ac5c9439-04ea-43db-9eec-8536b8948c2a_79ff16e3-929d-4e42-9084-caa3f0a117ad.html,,inhalation,discriminating conc.,4.5 mg/m3,no adverse effect observed, Strontium chloride,10476-85-4,Strontium chloride is not expected to show systemic effects up to 22.4 mg SrCl2/kg bw/d based on the outcome of a 90-day repeated dose toxicity study conducted with strontium chloride hexahydrate (NOAEL: 22.5 mg strontium chloride/kg bw/d; equal to 12.4 mg Sr/kg bw/d) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a60246d5-7e06-4250-8662-3abc3c90d00d/documents/IUC5-4ea506c6-5f6b-43d2-bbdc-2fd20fdc8903_1ddb9b83-a3b6-47dd-b693-28ce106fa8b9.html,,,,,, Strontium chloride,10476-85-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a60246d5-7e06-4250-8662-3abc3c90d00d/documents/IUC5-4ea506c6-5f6b-43d2-bbdc-2fd20fdc8903_1ddb9b83-a3b6-47dd-b693-28ce106fa8b9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,22.5 mg/kg bw/day,,rat Strontium chloride,10476-85-4,"Acute toxicity, oral: LD50 > 2000 mg/kg bwAcute toxicity, inhalation: LC50 > 3.4 mg/L +- 0.4 mg/L (calculated from strontium nitrate)Acute toxicity, dermal: data waiving ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a60246d5-7e06-4250-8662-3abc3c90d00d/documents/IUC5-44a2f03c-5a4f-4917-9483-c549c6a03440_1ddb9b83-a3b6-47dd-b693-28ce106fa8b9.html,,,,,, Strontium hydroxide,18480-07-4,Strontium hydroxide is not expected to show systemic effects up to 10.3 mg Sr(OH)2/kg bw/d based on read-across from a 90-day repeated dose toxicity study conducted with strontium chloride (NOAEL: 22.5 mg SrCl2.6H2O/kg bw/d; equal to 7.4 mg Sr/kg bw/d) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/674a72ef-59c0-47ca-b1ba-603bd744edaf/documents/IUC5-99788fc2-a644-49b2-8186-2d69a7edb885_47dd62df-da52-4c9c-8543-cb02f096263a.html,,,,,, Strontium hydroxide,18480-07-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/674a72ef-59c0-47ca-b1ba-603bd744edaf/documents/IUC5-99788fc2-a644-49b2-8186-2d69a7edb885_47dd62df-da52-4c9c-8543-cb02f096263a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10.3 mg/kg bw/day,,rat Strontium hydroxide,18480-07-4,"Acute toxicity, oral: data waiving; read-across from Sr(NO3)2: LD50 > 1149 mg/kg bw (> 828 mg Sr/kg bw).Acute toxicity, inhalation: data waivingAcute toxicity, dermal: data waiving ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/674a72ef-59c0-47ca-b1ba-603bd744edaf/documents/IUC5-e87b36a2-bd1d-4423-bc4f-7d8d5f8b566a_47dd62df-da52-4c9c-8543-cb02f096263a.html,,,,,, Strontium hydroxide,18480-07-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/674a72ef-59c0-47ca-b1ba-603bd744edaf/documents/IUC5-e87b36a2-bd1d-4423-bc4f-7d8d5f8b566a_47dd62df-da52-4c9c-8543-cb02f096263a.html,,oral,LD50,"> 1,149 mg/kg bw",no adverse effect observed, Strontium nitrate,10042-76-9,Strontium nitrate is not expected to show effects at 30.1 mg Sr(NO3)2/kg bw/d based on the 90-day repeated dose toxicity study conducted with strontium chloride. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91b91e51-3bd9-45fe-b5be-ae016019f59c/documents/IUC5-7806f1b1-e3b1-4b90-a9b1-7ef29ac8ba42_db759223-0e05-4f27-8a9d-5da427f07c6b.html,,,,,, Strontium nitrate,10042-76-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91b91e51-3bd9-45fe-b5be-ae016019f59c/documents/IUC5-7806f1b1-e3b1-4b90-a9b1-7ef29ac8ba42_db759223-0e05-4f27-8a9d-5da427f07c6b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30.1 mg/kg bw/day,,rat Strontium nitrate,10042-76-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91b91e51-3bd9-45fe-b5be-ae016019f59c/documents/IUC5-62df8b8f-59d6-4bc6-9b60-78a52924c6d0_db759223-0e05-4f27-8a9d-5da427f07c6b.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Strontium nitrate,10042-76-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91b91e51-3bd9-45fe-b5be-ae016019f59c/documents/IUC5-62df8b8f-59d6-4bc6-9b60-78a52924c6d0_db759223-0e05-4f27-8a9d-5da427f07c6b.html,,inhalation,discriminating conc.,4.5 mg/m3,no adverse effect observed, Strontium peroxide,1314-18-7, The oral LD50 value of Strontium Nitrate in Wistar rats was established to exceed 2000 mg/kg body weight. Considering the read-across approach the LD50 for strontium peroxide is considered similar. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5ac97de-86dc-49a5-b47f-b35f1b1276d6/documents/099241c0-7b5d-401c-a9ef-aa4af2c5b7e4_b4900b95-6cea-44cb-b5af-2a8f01062b74.html,,,,,, Strontium peroxide,1314-18-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5ac97de-86dc-49a5-b47f-b35f1b1276d6/documents/099241c0-7b5d-401c-a9ef-aa4af2c5b7e4_b4900b95-6cea-44cb-b5af-2a8f01062b74.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Strontium sulphide,1314-96-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df07cb34-f56a-4563-87a1-9a53c58e109a/documents/IUC5-4a46190e-96a5-4071-87eb-6bd9f1cca090_31de4b3c-a607-4df0-9903-89b42d130714.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.9 mg/kg bw/day,,rat Strontium sulphide,1314-96-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df07cb34-f56a-4563-87a1-9a53c58e109a/documents/IUC5-4a46190e-96a5-4071-87eb-6bd9f1cca090_31de4b3c-a607-4df0-9903-89b42d130714.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,390 mg/m3,,rat Strontium sulphide,1314-96-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df07cb34-f56a-4563-87a1-9a53c58e109a/documents/IUC5-4a46190e-96a5-4071-87eb-6bd9f1cca090_31de4b3c-a607-4df0-9903-89b42d130714.html,Repeated dose toxicity – local effects,inhalation,NOAEC,49.1 mg/m3,adverse effect observed,rat Strontium sulphide,1314-96-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Data are in accordance with current requirements and read across is fully justified (see discussion). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df07cb34-f56a-4563-87a1-9a53c58e109a/documents/IUC5-a009bc8a-49b4-4b80-9d3e-440464f4488b_31de4b3c-a607-4df0-9903-89b42d130714.html,,,,,, Strontium sulphide,1314-96-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df07cb34-f56a-4563-87a1-9a53c58e109a/documents/IUC5-a009bc8a-49b4-4b80-9d3e-440464f4488b_31de4b3c-a607-4df0-9903-89b42d130714.html,,oral,LD50,233.5 mg/kg bw,adverse effect observed, 1-phenylethanol,98-85-1," Repeated dose toxicity: Oral In a combined repeated dose and carcinogenicity study, the toxic effects of 1-phenylethanol was evaluated in B6C3F1 mice for sixteen days. The mice were orally (gavage) exposed to the test chemical in a dosage of 0, 125, 250, 500, 1000 or 2000 mg/kg.Sixteen of 18 mice that received 1000 or 2000 mg/kg died within 3 days. A decrease up to 21% in body weight were observed in male and female mice after treatment withα-methylbenzyl alcohol. The results also showed no compound-related histopathologic lesions were observed. Therefore, NOAEL was considered to be 500 mg/kg when male and femaleB6C3F1 were orally exposed toα-methylbenzyl alcohol for sixteen days. Repeated dose toxicity: Inhalation According to the quantitative structure activity relationship model prediction, the study NOEL of the substance by the inhalation route is estimated to be 2.8 mg/kg/day in F 344 rats.This indicates that 1-phenylethanol shall not exhibit toxic effect to rat by the inhalative route below the above mention dose. Repeated dose toxicity: Dermal The standard acute toxicity test gave an LD50 value of >2500 mg/kg body weight. It is therefore assumed that 1-phenylethanol shall not exhibit repeated dose toxicity (in a 28 day test) by the dermal route. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b31245db-cf87-44ce-8bbd-570f3bd83bed/documents/c579b84d-6121-4daa-9c58-fa17960ccaa8_2b0e8848-6af2-439e-a103-69ea874cbbd0.html,,,,,, 1-phenylethanol,98-85-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b31245db-cf87-44ce-8bbd-570f3bd83bed/documents/c579b84d-6121-4daa-9c58-fa17960ccaa8_2b0e8848-6af2-439e-a103-69ea874cbbd0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,mouse 1-phenylethanol,98-85-1," Acute oral toxicity:  Acute oral toxicity dose (LD50) for target chemical 1-phenylethan-1-ol (1-phenylethanol) (CAS No. 98-85-1) was considered based on experimental study conducted on rats. The LD50 value was considered in between 300 – ≤ 2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, 1-phenylethan-1-ol (1-phenylethanol) can be classified in “Category 4” for acute oral toxicity. Acute Inhalation toxicity: The acute Inhalation toxicity dose (LC50) for 1-phenylethan-1-ol (1-phenylethanol) (CAS No. 98-85-1) was considered based on the data available for the structurally and functionally similar read across chemicals. The study concluded that the LC50 value is >5 mg/L, for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, 1-phenylethan-1-ol (1-phenylethanol) cannot be classified for acute inhalation toxicity. Acute Dermal toxicity: The acute dermal toxicity dose (LD50) for target chemical 1-phenylethan-1-ol (1-phenylethanol) (CAS No. 98-85-1) was considered based on experimental study conducted on rats, the value was considered to be >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 1-phenylethan-1-ol (1-phenylethanol) cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b31245db-cf87-44ce-8bbd-570f3bd83bed/documents/a50829b2-42dc-4b9e-81d8-edd85308a353_2b0e8848-6af2-439e-a103-69ea874cbbd0.html,,,,,, 1-phenylethanol,98-85-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b31245db-cf87-44ce-8bbd-570f3bd83bed/documents/a50829b2-42dc-4b9e-81d8-edd85308a353_2b0e8848-6af2-439e-a103-69ea874cbbd0.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, 1-phenylethanol,98-85-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b31245db-cf87-44ce-8bbd-570f3bd83bed/documents/a50829b2-42dc-4b9e-81d8-edd85308a353_2b0e8848-6af2-439e-a103-69ea874cbbd0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-phenylethanol,98-85-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b31245db-cf87-44ce-8bbd-570f3bd83bed/documents/a50829b2-42dc-4b9e-81d8-edd85308a353_2b0e8848-6af2-439e-a103-69ea874cbbd0.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Gum benzoin, Siam",9000-72-0, Acute oral toxicity (tested in a study similar to OECD TG 401): LD50 > 5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff0be605-266d-4827-81f3-b4d96bb809f1/documents/9b55f81d-76e8-4857-8626-412d7b5ef6d2_30d89fd6-4143-4e55-ac7f-4cd1d19ca08e.html,,,,,, "Styrax benzoin, ext.",84929-79-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a674e70-2042-4226-8502-f006fe23cc77/documents/a38190cb-0c0b-4acf-b9fb-908c777bc773_4c4bd33c-070e-4517-92f7-52d763f21a92.html,,oral,LD50,"2,499 mg/kg bw",no adverse effect observed, Styrene,100-42-5,"- human: effects on colour vision after long-term inhalation: NOAEC = 50 ppm (8-hr TWA) (Seeber et al., 2009)   Inhalation: - human: ototoxicity after long-term inhalation: NOAEC = 20 ppm (Triebig et al., 2009) - rat: ototoxicity after long-term inhalation: NOAEC = 500 ppm (Lataye et al., 2005) - rat: developmental toxicity after long-term inhalation: NOAEC = 500 ppm (Cruzan et al., 2005a, b) Dermal: corrected NOAEL = 615 mg/kg/d (Triebig et al., 2009), resulting from route-to-route extrapolation (inhalation to dermal route)  ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04f487d5-639c-4bf2-83ce-58ec4161a38a/documents/IUC5-41a8cb3f-b919-49ce-b5a6-ceab52af4466_c7c004c3-1974-42f7-a143-64de36d15f1e.html,,,,,, Styrene,100-42-5,"- acute inhalation toxicity: study with 6 human volunteers exposed for 7 hours: NOAEC = 100 ppm; no effects on the central nervous system (CNS) function at this concentration (Stewart et al., 1968).- acute inhalation toxicity: rat, 4 h inhalation: LC50 = 2770 ppm (11.8 mg/l) (Shugaev, 1969). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04f487d5-639c-4bf2-83ce-58ec4161a38a/documents/IUC5-db6f02e9-1b19-4367-a178-801eac97d45f_c7c004c3-1974-42f7-a143-64de36d15f1e.html,,,,,, (epoxyethyl)benzene,96-09-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The data is considered reliable based on the principles used in the the study and the sufficient documentation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8c82d01-2d41-4b35-b4e0-f9e8039eb287/documents/IUC5-10a50ffa-7176-455e-bd1b-9d70326a04d5_5573e3f0-3eb0-4f2f-bab6-afad4f7f1e02.html,,,,,, (epoxyethyl)benzene,96-09-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8c82d01-2d41-4b35-b4e0-f9e8039eb287/documents/IUC5-10a50ffa-7176-455e-bd1b-9d70326a04d5_5573e3f0-3eb0-4f2f-bab6-afad4f7f1e02.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,180 mg/kg bw/day,,mouse (epoxyethyl)benzene,96-09-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8c82d01-2d41-4b35-b4e0-f9e8039eb287/documents/IUC5-5775aaf9-d4d1-4c78-8456-938a0a730e7d_5573e3f0-3eb0-4f2f-bab6-afad4f7f1e02.html,,oral,LD50,"4,290 mg/kg bw",adverse effect observed, (epoxyethyl)benzene,96-09-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8c82d01-2d41-4b35-b4e0-f9e8039eb287/documents/IUC5-5775aaf9-d4d1-4c78-8456-938a0a730e7d_5573e3f0-3eb0-4f2f-bab6-afad4f7f1e02.html,,dermal,LD50,"1,060 mg/kg bw",adverse effect observed, (epoxyethyl)benzene,96-09-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8c82d01-2d41-4b35-b4e0-f9e8039eb287/documents/IUC5-5775aaf9-d4d1-4c78-8456-938a0a730e7d_5573e3f0-3eb0-4f2f-bab6-afad4f7f1e02.html,,inhalation,LC50,"2,450 mg/m3",adverse effect observed, Subtilisin,9014-01-1,"The repeated dose oral toxicity of subtilisin has been tested in a 90-day study, the repeated dose dermal toxicity was tested in a 28-day study, while the repeated dose inhalation toxicity was waived. - The repeated dose oral toxicity was a subchronic toxicity test similar to the principles of OECD guideline 408 (version 25 june 2018), and in compliance with GLP. The conclusion was that the No Observed Adverse Effect Level (NOAEL) in rats was considered to be the highest dose level administered, equivalent to 572 mg enzyme concentrate dry matter/kg bwt/day (equivalent to 302.6 mg active enzyme protein/kg bwt/day). - The dermal study concluded that the dose applied daily, 10 mg/kg/day (only one dose level tested), was without any significant effects, only sporadic, minimal grade local skin reactions. It is further highly unlikely that enzymes should be absorbed through the skin due to the molecular weight and the physico-chemical properties of the protein molecule. - The inhalation study was waived because exposure is too low to exert any toxicological concern. Potential exposure by inhalation to an amount of enzyme, which is toxicologically relevant, is unrealistic due to the stringent work practices and the formulation of enzymes, enforced because of the risk of sensitization by inhalation. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch 2 study - only one dose level tested. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): Klimisch 2 study - only one dose level tested. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): High quality. The key study is GLP compliant and Klimisch 1. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6e7378b-c3c9-4cef-bfb4-81d4fc812ea5/documents/IUC5-1362b1f2-eb0b-4b30-9d64-8f7076d591f5_95d2af9e-57e2-462d-a71a-8b9085f88102.html,,,,,, Subtilisin,9014-01-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6e7378b-c3c9-4cef-bfb4-81d4fc812ea5/documents/IUC5-1362b1f2-eb0b-4b30-9d64-8f7076d591f5_95d2af9e-57e2-462d-a71a-8b9085f88102.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rabbit Subtilisin,9014-01-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6e7378b-c3c9-4cef-bfb4-81d4fc812ea5/documents/IUC5-1362b1f2-eb0b-4b30-9d64-8f7076d591f5_95d2af9e-57e2-462d-a71a-8b9085f88102.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,572 mg/kg bw/day,,rat Subtilisin,9014-01-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6e7378b-c3c9-4cef-bfb4-81d4fc812ea5/documents/IUC5-1362b1f2-eb0b-4b30-9d64-8f7076d591f5_95d2af9e-57e2-462d-a71a-8b9085f88102.html,Repeated dose toxicity – local effects,dermal,NOAEL,167 ,no adverse effect observed, Subtilisin,9014-01-1,"The acute oral toxicity of subtilisin has been tested, while the acute inhalation and dermal toxicity was regarded as scientifically unjustified. The acute oral toxicity was a short-term toxicity test procedure similar to OECD guideline 401, and in compliance with GLP. The conclusion is that subtilisin could be harmful by oral exposure (GHS Toxicity category IV). Based on weight of evidence, subtilisin does not exert any acute dermal or inhalation toxicity  under foreseeable realistic exposures for both workers and consumers. Sufficient exposure by inhalation of subtilisin would produce acute irritating effects, but this is prevented due to the controls put in place concerning the allergenic effects of enzymes by inhalation. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): High quality. Study is in accordance with GLP and Klimisch 1. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): High quality. Toxicological data has been generated within the enzyme producing industry during the last 40 years. Substantial documentation on the safety of the production strains has been generated, and the enzyme test materials are thoroughly characterized. High quality studies for all relevant endpoints, in vivo studies as well as in vitro studies, show that industrial enzymes from well-known and well-characterized production strains have very similar safety profiles across the catalytic activities. Read-across can therefore be applied for the majority of toxicological endpoints. The database can be considered of high quality. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): High quality. Toxicological data has been generated within the enzyme producing industry during the last 40 years. Substantial documentation on the safety of the production strains has been generated, and the enzyme test materials are thoroughly characterized. High quality studies for all relevant endpoints, in vivo studies as well as in vitro studies, show that industrial enzymes from well-known and well-characterized production strains have very similar safety profiles across the catalytic activities. Read-across can therefore be applied for the majority of toxicological endpoints. The database can be considered of high quality. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6e7378b-c3c9-4cef-bfb4-81d4fc812ea5/documents/IUC5-650210c9-2fd7-45ed-b45c-4c5e114a0fc7_95d2af9e-57e2-462d-a71a-8b9085f88102.html,,,,,, Subtilisin,9014-01-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6e7378b-c3c9-4cef-bfb4-81d4fc812ea5/documents/IUC5-650210c9-2fd7-45ed-b45c-4c5e114a0fc7_95d2af9e-57e2-462d-a71a-8b9085f88102.html,,oral,LD50,"1,728 mg/kg bw",adverse effect observed, Succinic acid,110-15-6,"Na-succinate, and by this succinic acid, was of low toxicity in a 90-day study and a 2-years study with administration in drinking water to rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32ca1ab3-b4a3-4787-81a7-c3a3ca10fa2e/documents/IUC5-aa61528a-6e9a-46d2-b19d-196b89b0e386_65b5bb9e-ea50-4012-97c9-967fbe1417b6.html,,,,,, Succinic acid,110-15-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32ca1ab3-b4a3-4787-81a7-c3a3ca10fa2e/documents/IUC5-aa61528a-6e9a-46d2-b19d-196b89b0e386_65b5bb9e-ea50-4012-97c9-967fbe1417b6.html,Chronic toxicity – systemic effects,oral,NOAEL,860 mg/kg bw/day,,rat Succinic acid,110-15-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32ca1ab3-b4a3-4787-81a7-c3a3ca10fa2e/documents/IUC5-aa61528a-6e9a-46d2-b19d-196b89b0e386_65b5bb9e-ea50-4012-97c9-967fbe1417b6.html,Chronic toxicity – systemic effects,dermal,NOAEL,860 mg/kg bw/day,,rat Succinic acid,110-15-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32ca1ab3-b4a3-4787-81a7-c3a3ca10fa2e/documents/IUC5-aa61528a-6e9a-46d2-b19d-196b89b0e386_65b5bb9e-ea50-4012-97c9-967fbe1417b6.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,130 mg/m3",,rat Succinic acid,110-15-6,The acute toxicity of succinic acid is low. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32ca1ab3-b4a3-4787-81a7-c3a3ca10fa2e/documents/IUC5-bb9044db-3882-4a56-8132-2c51b0121948_65b5bb9e-ea50-4012-97c9-967fbe1417b6.html,,,,,, Succinic acid,110-15-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32ca1ab3-b4a3-4787-81a7-c3a3ca10fa2e/documents/IUC5-bb9044db-3882-4a56-8132-2c51b0121948_65b5bb9e-ea50-4012-97c9-967fbe1417b6.html,,oral,LD50,"6,740 mg/kg bw",, Succinic acid,110-15-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32ca1ab3-b4a3-4787-81a7-c3a3ca10fa2e/documents/IUC5-bb9044db-3882-4a56-8132-2c51b0121948_65b5bb9e-ea50-4012-97c9-967fbe1417b6.html,,dermal,LD50,"6,740 mg/kg bw",, Succinic acid,110-15-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32ca1ab3-b4a3-4787-81a7-c3a3ca10fa2e/documents/IUC5-bb9044db-3882-4a56-8132-2c51b0121948_65b5bb9e-ea50-4012-97c9-967fbe1417b6.html,,inhalation,LC50,"1,284 mg/m3",, Succinic anhydride,108-30-5," Suitable data were available to assess the toxicity of succinic anhydride after repeated dose exposure. Therefore, the available data from repeated dose toxicity studies conducted with succinic anhydride were used in a weight of evidence approach to assess the specific target organ toxicity of the target substance. Based on the results and in accordance with CLP Regulation 1272/2008, classification of the target substance is not warranted. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aaefe183-0d67-4445-a44a-107dda0a4094/documents/IUC5-7f190377-1adb-437f-a3e1-7d1e12f9aa1d_7764957b-ded5-496e-b021-7ebf8ebfcf41.html,,,,,, Succinic anhydride,108-30-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aaefe183-0d67-4445-a44a-107dda0a4094/documents/IUC5-7f190377-1adb-437f-a3e1-7d1e12f9aa1d_7764957b-ded5-496e-b021-7ebf8ebfcf41.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Succinic anhydride,108-30-5," Data are available to assess the acute oral and dermal toxicity of the target substance succinic anhydride. Succinic anhydride was of low toxicity as indicated by the combined LD50 (male/female) of 1794.9 mg/kg bw, when tested in an acute oral toxicity study comparable to OECD TG 401. When tested for acute dermal toxicity, succinic anhydride did not show signs of toxicity or death up to the limit dose of 2000 mg/kg bw in a study similar to OECD TG 402. Acute inhalation testing is not required. The results of the granulometry indicate the L10 value for particle size was 377 µm and the L50 was greater than 1100 µm. On the basis of these results it is clear that the particles present in the batch of succinic anhydride are not in the respirable size range for rats or humans and so inhalation exposure is not likely. Given the results can be predicted from the physical-chemical properties and that there are already studies available from two relevant exposure routes, an inhalation toxicity study cannot be justified because of animal welfare reasons. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aaefe183-0d67-4445-a44a-107dda0a4094/documents/IUC5-8aa1af0f-472f-45ec-877d-e85b1b3b3cd3_7764957b-ded5-496e-b021-7ebf8ebfcf41.html,,,,,, Succinic anhydride,108-30-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aaefe183-0d67-4445-a44a-107dda0a4094/documents/IUC5-8aa1af0f-472f-45ec-877d-e85b1b3b3cd3_7764957b-ded5-496e-b021-7ebf8ebfcf41.html,,oral,LD50,"1,794.9 mg/kg bw",adverse effect observed, Succinic anhydride,108-30-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aaefe183-0d67-4445-a44a-107dda0a4094/documents/IUC5-8aa1af0f-472f-45ec-877d-e85b1b3b3cd3_7764957b-ded5-496e-b021-7ebf8ebfcf41.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,6-dichloro-1,6-dideoxy-β-D-fructofuranosyl 4-chloro-4-deoxy-α-D-galactose",56038-13-2," The repeated dose toxicity of the test item via oral application on rats was determined in a GLP study according to FDA guidelines. It is concluded that the oral administration of sucralose to CD rats at dosages of up to 3000 mg/kg/day, for 26 weeks resulted in only a few minor treatment-related changes. These included a dosage-related enlargement of the caecum and a small increase in bodyweight-relative kidney weight at 3000 mg/kg/day. No histopathological changes were noted in either organ and the kidney weight changes did not correspond to any haematological or clinical chemistry changes. The dose related increase in water intake, slight decrease in adjusted bodyweight at 3000 mg/kg/day and caecal enlargement are not uncommon findings when high doses of poorly absorbed materials are administered to rats. Therefore, in the absence of any histopathological or other findings of an adverse nature, none of the changes observed are considered to be toxicologically significant. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4144332f-7f94-4d74-a5b7-2dd52eeb83c0/documents/a035204b-9333-46f2-bc6e-9f02a4d9c632_4931f4d6-2020-4e4b-84c8-48e47561b4bb.html,,,,,, "1,6-dichloro-1,6-dideoxy-β-D-fructofuranosyl 4-chloro-4-deoxy-α-D-galactose",56038-13-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4144332f-7f94-4d74-a5b7-2dd52eeb83c0/documents/a035204b-9333-46f2-bc6e-9f02a4d9c632_4931f4d6-2020-4e4b-84c8-48e47561b4bb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,000 mg/kg bw/day",,rat "1,6-dichloro-1,6-dideoxy-β-D-fructofuranosyl 4-chloro-4-deoxy-α-D-galactose",56038-13-2, The toxicity of the test item on rats was determined in a non-GLP study comparable to OECD 401. The oral LD50 was determined to be >10000 mg/kg bw (test material) in rats under the conditions of the test. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4144332f-7f94-4d74-a5b7-2dd52eeb83c0/documents/8e00a972-ef8e-4087-be49-c8ad8a0de15d_4931f4d6-2020-4e4b-84c8-48e47561b4bb.html,,,,,, "1,6-dichloro-1,6-dideoxy-β-D-fructofuranosyl 4-chloro-4-deoxy-α-D-galactose",56038-13-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4144332f-7f94-4d74-a5b7-2dd52eeb83c0/documents/8e00a972-ef8e-4087-be49-c8ad8a0de15d_4931f4d6-2020-4e4b-84c8-48e47561b4bb.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "α-d-Glucopyranoside, β-d-fructofuranosyl, benzoate",12738-64-6, Read-across from data on benzoic acid: Repeated oral rat study by Kieckebusch and Lang (1960) Subactute inhalation rat study by Rop (1981) Subacute dermal rabbit study (OECD 2001) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47d1e37d-8b62-4005-8414-aa27c1819204/documents/b8998edb-aa4a-4b22-8bbc-8af8393d75e8_c67b4824-af48-4c08-b65b-eda0a3fb7d4a.html,,,,,, "α-d-Glucopyranoside, β-d-fructofuranosyl, benzoate",12738-64-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47d1e37d-8b62-4005-8414-aa27c1819204/documents/b8998edb-aa4a-4b22-8bbc-8af8393d75e8_c67b4824-af48-4c08-b65b-eda0a3fb7d4a.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,500 mg/kg bw/day",,rabbit "α-d-Glucopyranoside, β-d-fructofuranosyl, benzoate",12738-64-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47d1e37d-8b62-4005-8414-aa27c1819204/documents/b8998edb-aa4a-4b22-8bbc-8af8393d75e8_c67b4824-af48-4c08-b65b-eda0a3fb7d4a.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,250 mg/m3,,rat "α-d-Glucopyranoside, β-d-fructofuranosyl, benzoate",12738-64-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47d1e37d-8b62-4005-8414-aa27c1819204/documents/b8998edb-aa4a-4b22-8bbc-8af8393d75e8_c67b4824-af48-4c08-b65b-eda0a3fb7d4a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "α-d-Glucopyranoside, β-d-fructofuranosyl, benzoate",12738-64-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47d1e37d-8b62-4005-8414-aa27c1819204/documents/b8998edb-aa4a-4b22-8bbc-8af8393d75e8_c67b4824-af48-4c08-b65b-eda0a3fb7d4a.html,Repeated dose toxicity – local effects,inhalation,LOAEC,25 mg/m3,adverse effect observed,rat "α-d-Glucopyranoside, β-d-fructofuranosyl, benzoate",12738-64-6," Read-across from data on benzoic acid from acute toxicity studies by the the oral, dermal and inhalational route. Read-across of these data to sucrose benzoate is considered a very precautious approach, as sucrose benzoate because of low water solubility (3 mg/L) and high molacular weight (1175 g/mol) can be considered as far less bioaccessible and bioavailable than benzoic acid by the oral, dermal and inhalational route. See read-across justification attached to section 13. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47d1e37d-8b62-4005-8414-aa27c1819204/documents/27616b35-ecbd-4038-a4bb-ae0678419d37_c67b4824-af48-4c08-b65b-eda0a3fb7d4a.html,,,,,, "α-d-Glucopyranoside, β-d-fructofuranosyl, benzoate",12738-64-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47d1e37d-8b62-4005-8414-aa27c1819204/documents/27616b35-ecbd-4038-a4bb-ae0678419d37_c67b4824-af48-4c08-b65b-eda0a3fb7d4a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "α-d-Glucopyranoside, β-d-fructofuranosyl, benzoate",12738-64-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47d1e37d-8b62-4005-8414-aa27c1819204/documents/27616b35-ecbd-4038-a4bb-ae0678419d37_c67b4824-af48-4c08-b65b-eda0a3fb7d4a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "α-d-Glucopyranoside, β-d-fructofuranosyl, benzoate",12738-64-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47d1e37d-8b62-4005-8414-aa27c1819204/documents/27616b35-ecbd-4038-a4bb-ae0678419d37_c67b4824-af48-4c08-b65b-eda0a3fb7d4a.html,,inhalation,LC50,0.012 mg/m3,no adverse effect observed, "Castor oil, sulfated",8002-33-3," Acute oral toxicity: Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Castor oil, sulfated (CAS no.: 8002-33-3). The studies are as mentioned below: 1. Acute Oral toxicity study was conducted by using test chemical in 20 fasted rats at oral dose 39.8 g/kg as a 90% w/v concentration in corn oil. Animals were observed for mortality for 14 days. No mortality was observed at 39800 mg/kg bw. Therefore, LD50 was considered to be >39800 mg/kg bw, when 20 male and female rats were treated with test chemical via oral route. 2. Acute Oral toxicity study was conducted by using test chemical in 10 Sprague-Dawley rats at oral dose 20.0 g/kg bw. Animals were observed for mortality for 14 days. Necropsy was performed. No mortality was observed at 20000 mg/kg bw. At necropsy, none of the animals had gross lesions. Therefore, LD50 was considered to be >20000 mg/kg bw, when 10 male and female Sprague-Dawley rats were treated with test chemical via oral route. Thus, based on the above summarised studies, Castor oil, sulfated (CAS no.: 8002-33-3) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Castor oil, sulfated (CAS no.: 8002-33-3) cannot be classified for acute oral toxicity. Hence, Castor oil, sulfated is not likely to be toxic in the dose range of >20000 - >39800 mg/Kg bw. Acute Dermal Toxicity: Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute dermal toxicity of the test chemical Castor oil, sulfated (CAS no.: 8002-33-3). The studies are as mentioned below: 1. Acute Dermal toxicity study was conducted by using test chemical in 8 male and female albino rabbits at dose of 6800 mg/kg and 10200 mg/kg bw. 2 groups of 2 male and 2 female albino rabbits received a 24-hour patch test of a cosmetic cleansing cream containing 3% test chemical. One group received the undiluted product in a dose of 6.8 g/kg; the other, 10.2 g/kg. Animals were observed for mortality and clinical signs for 14 days. No mortality was observed at 10200 mg/kg bw. Abnormal behaviour, adverse body weight changes, or gross alterations were noted during the 14-day observation period. At the end of the 24-hour contact period, definite red, well-defined erythema was observed at the contact site on each animal. The erythema subsided by Day 7. Therefore, LD50 was considered to be >10200 mg/kg bw, when 8 male and female albino rabbits were treated with test chemical by dermal application. 2. The study was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was found to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that given test chemical does not classify as an acute dermal toxicant.  CLP Classification: “Not classified”. Thus, based on the above summarised studies, Castor oil, sulfated (CAS no.: 8002-33-3) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Castor oil, sulfated (CAS no.: 8002-33-3) cannot be classified for acute dermal toxicity. Hence, Castor oil, sulfated is not likely to be toxic in the dose range of >2000 - >10200 mg/Kg bw for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20769fa6-4095-4813-b645-55125e53bd04/documents/defb02a4-6c44-4243-9aae-2b6f891f5b17_ad68348f-bc6c-4305-9a8b-30a2f1615493.html,,,,,, "Castor oil, sulfated",8002-33-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20769fa6-4095-4813-b645-55125e53bd04/documents/defb02a4-6c44-4243-9aae-2b6f891f5b17_ad68348f-bc6c-4305-9a8b-30a2f1615493.html,,oral,LD50,"39,800 mg/kg bw",no adverse effect observed, "Castor oil, sulfated",8002-33-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20769fa6-4095-4813-b645-55125e53bd04/documents/defb02a4-6c44-4243-9aae-2b6f891f5b17_ad68348f-bc6c-4305-9a8b-30a2f1615493.html,,dermal,LD50,"10,200 mg/kg bw",no adverse effect observed, Sulphuric acid,7664-93-9,"A large number of repeated dose toxicity studies have been performed with sulphuric acid, all of which used inhalation exposure to sulphuric acid aerosol/mist, in several animal species. No studies with the oral route were available. However, there is no potential for oral exposure following the normal use of sulphuric acid; the routes of exposure relevant to occupational exposure are inhalation and dermal. Information from acute toxicity studies indicates much greater sensitivity following inhalation exposure and no systemic toxicity following oral exposure. Testing for repeated dose toxicity by the oral route cannot therefore be justified on scientific grounds. Given the corrosive nature of the substance, testing is also not justified for reasons of animal welfare. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9868902f-b988-48e5-bc1a-d62c80336b02/documents/IUC5-88649944-21e6-470d-a93f-9037ab8bf95c_81da1b14-1f7e-4ac5-977a-752f75b42fef.html,,,,,, Sulphuric acid,7664-93-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9868902f-b988-48e5-bc1a-d62c80336b02/documents/IUC5-88649944-21e6-470d-a93f-9037ab8bf95c_81da1b14-1f7e-4ac5-977a-752f75b42fef.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,0.3 mg/m3,,rat Sulphuric acid,7664-93-9,A single acute oral toxicity study is available; this is broadly comparable to OECD Guideline 401. No acute dermal toxicity studies are available. A large number of non-standard acute inhalation studies are available; studies were performed in various species and using various exposure times. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9868902f-b988-48e5-bc1a-d62c80336b02/documents/IUC5-6c1c77f8-a97b-4774-bfcd-41130b468984_81da1b14-1f7e-4ac5-977a-752f75b42fef.html,,,,,, Sulphuric acid,7664-93-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9868902f-b988-48e5-bc1a-d62c80336b02/documents/IUC5-6c1c77f8-a97b-4774-bfcd-41130b468984_81da1b14-1f7e-4ac5-977a-752f75b42fef.html,,inhalation,LC50,375 mg/m3,adverse effect observed, "Sunflower oil, ester with sorbitol",96690-53-8, LD50 > 2000 mg/kg bw was obtained in rats. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab05ce1e-625f-443e-bb61-a47cd4baaa36/documents/66c61a5d-d260-47d6-bf68-ea8cfed8367d_081ae2b7-e019-427d-86eb-6724184789f7.html,,,,,, "Sunflower oil, ester with sorbitol",96690-53-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab05ce1e-625f-443e-bb61-a47cd4baaa36/documents/66c61a5d-d260-47d6-bf68-ea8cfed8367d_081ae2b7-e019-427d-86eb-6724184789f7.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Fluorphlogopite (Mg3K[AlF2O(SiO3)3]),12003-38-2,"A chemically very similar compound of Fluorphlogopite showed no adverse effects in a 90-day repeat dose toxicity study in rats. Fluorphlogopite is a practically insoluble, inert mineral. Systemic effects after repeated exposure are highly unlikely. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c1fb745-0d94-4ca2-9933-776e26761016/documents/IUC5-88c40707-94b9-45b4-903e-c650aba3928a_079f6cb5-1efe-49cb-a43f-96c62a27cd6f.html,,,,,, Fluorphlogopite (Mg3K[AlF2O(SiO3)3]),12003-38-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c1fb745-0d94-4ca2-9933-776e26761016/documents/IUC5-88c40707-94b9-45b4-903e-c650aba3928a_079f6cb5-1efe-49cb-a43f-96c62a27cd6f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat Fluorphlogopite (Mg3K[AlF2O(SiO3)3]),12003-38-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): A acute inhalation toxicity study (limit test) has been performed with Fluorphlogopite according to Guideline OECD 403 under GLP regulation. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c1fb745-0d94-4ca2-9933-776e26761016/documents/IUC5-01223808-8387-4234-9c43-8540a81c60b4_079f6cb5-1efe-49cb-a43f-96c62a27cd6f.html,,,,,, Fluorphlogopite (Mg3K[AlF2O(SiO3)3]),12003-38-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c1fb745-0d94-4ca2-9933-776e26761016/documents/IUC5-01223808-8387-4234-9c43-8540a81c60b4_079f6cb5-1efe-49cb-a43f-96c62a27cd6f.html,,oral,LD50,"9,000 mg/kg bw",no adverse effect observed, Fluorphlogopite (Mg3K[AlF2O(SiO3)3]),12003-38-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c1fb745-0d94-4ca2-9933-776e26761016/documents/IUC5-01223808-8387-4234-9c43-8540a81c60b4_079f6cb5-1efe-49cb-a43f-96c62a27cd6f.html,,inhalation,LC50,"5,100 mg/m3",no adverse effect observed, tert-butyl acetate,540-88-5,"Repeated dose toxicity: inhalation Effect level (male rat) LOAEC = 100 ppm Target organ: kidney Effect level (female rat) NOAEC = 400 ppm Target organ: liver, adrenal gland ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b5241f2-104f-4dc8-adad-1e15ae233d20/documents/IUC5-970da85c-380a-4afc-9221-b38a67e22847_86672ead-5445-4ae9-abd9-f642f75a67f2.html,,,,,, tert-butyl acetate,540-88-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b5241f2-104f-4dc8-adad-1e15ae233d20/documents/IUC5-26b8f383-9224-4a72-b184-33b66f87069c_86672ead-5445-4ae9-abd9-f642f75a67f2.html,,oral,LD50,"4,500 mg/kg bw",, tert-butyl acetate,540-88-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b5241f2-104f-4dc8-adad-1e15ae233d20/documents/IUC5-26b8f383-9224-4a72-b184-33b66f87069c_86672ead-5445-4ae9-abd9-f642f75a67f2.html,,inhalation,LC50,"199,918 mg/m3",, 2-methylpropan-2-ol,75-65-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d926aec-4b25-46d4-a5ce-132a5a833b0f/documents/IUC5-f5eccc9d-3d88-40c6-89ef-66ffc65ea98d_8287b65c-03df-4d8e-97d3-ad2a9222d3dc.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,406 mg/m3,,rat 2-methylpropan-2-ol,75-65-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d926aec-4b25-46d4-a5ce-132a5a833b0f/documents/IUC5-f5eccc9d-3d88-40c6-89ef-66ffc65ea98d_8287b65c-03df-4d8e-97d3-ad2a9222d3dc.html,Chronic toxicity – systemic effects,oral,LOAEL,90 mg/kg bw/day,,rat tert-butyl perbenzoate,614-45-9,"14-day (dose levels 70, 140, 278, 556 and 1112 mg/kg) and 13-week (dose levels 0, 30, 60, 125, 250 and 500 mg/kg) studies in both mice and rat (NTP, 1992) resulted to a NOEAL of 30 mg/kg for forestomach lesions. Systemic toxicity was not observed in either species with oral doses as high as 1112 mg. In the 13-week study, only observed effects at study termination were slightly lower thymus and spleen weights (absolute and relative to BW) in males at the highest dose level of 500 mg/kg. Other variations in organ weights observed in male and female rats appeared neither remarkable nor dose-related. Histopathological examination revealed no lesions that were considered related to administration of t-BP. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Well conducted studies, by the National Toxicology Program, in rats and mice. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0492d9e3-ade9-4273-85bc-2bc97bc8d50b/documents/IUC5-62f56f35-a5a8-48b4-b858-de3dbae474a6_9c81361e-afc2-4172-bfe1-813fff64d6ae.html,,,,,, tert-butyl perbenzoate,614-45-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0492d9e3-ade9-4273-85bc-2bc97bc8d50b/documents/IUC5-62f56f35-a5a8-48b4-b858-de3dbae474a6_9c81361e-afc2-4172-bfe1-813fff64d6ae.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat tert-butyl perbenzoate,614-45-9,"Recent studies evaluated the acute toxicity of tert-Butyl peroxybenzoate by oral, dermal and inhalation route: The acute oral toxicity study according to the Acute Toxic Class method (OECD 423) resulted to no mortality and only minor clinical signs in one animal on one day only after dosing with 2000 mg/kg. The LD50 cut-off has therefore been established to be greater than 5000 mg/kg bw. The LD50 after single dermal administration to rats of both sexes (OECD 402) was greater than 2000 mg/kg bw. The 4h-LC50 was estimated to be between 4.9 and 1.01 mg/L air (chemically determined mean aerosol concentration). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): A study, reliable without restrictions, is available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): A study, reliable without restrictions, is available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): A study, reliable without restrictions, is available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0492d9e3-ade9-4273-85bc-2bc97bc8d50b/documents/IUC5-6eb27b34-488a-4fae-a988-4a53fa155833_9c81361e-afc2-4172-bfe1-813fff64d6ae.html,,,,,, tert-butyl perbenzoate,614-45-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0492d9e3-ade9-4273-85bc-2bc97bc8d50b/documents/IUC5-6eb27b34-488a-4fae-a988-4a53fa155833_9c81361e-afc2-4172-bfe1-813fff64d6ae.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, tert-butyl perbenzoate,614-45-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0492d9e3-ade9-4273-85bc-2bc97bc8d50b/documents/IUC5-6eb27b34-488a-4fae-a988-4a53fa155833_9c81361e-afc2-4172-bfe1-813fff64d6ae.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, tert-butyl perbenzoate,614-45-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0492d9e3-ade9-4273-85bc-2bc97bc8d50b/documents/IUC5-6eb27b34-488a-4fae-a988-4a53fa155833_9c81361e-afc2-4172-bfe1-813fff64d6ae.html,,inhalation,LC50,"1,010 mg/m3",adverse effect observed, tert-butyl methacrylate,585-07-9," RA oral: OECD 408, GLP compliant, K1; rats, oral (gavage): NOAEL = 120 mg/kg bw/d RA inhalation: OECD 412, GLP compliant, K1; rats, inhalation (vapour): NOAEC systemic 11175 mg/m3, NOAEC local 1832 mg/m3 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66a285c1-8ac9-4831-8b0c-e56f103f148e/documents/IUC5-9f21fc85-e364-49b3-bede-adc85d270407_c32b39ab-f0ca-46b0-9aa4-2ddbee626b49.html,,,,,, tert-butyl methacrylate,585-07-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66a285c1-8ac9-4831-8b0c-e56f103f148e/documents/IUC5-9f21fc85-e364-49b3-bede-adc85d270407_c32b39ab-f0ca-46b0-9aa4-2ddbee626b49.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"11,175 mg/m3",,rat tert-butyl methacrylate,585-07-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66a285c1-8ac9-4831-8b0c-e56f103f148e/documents/IUC5-9f21fc85-e364-49b3-bede-adc85d270407_c32b39ab-f0ca-46b0-9aa4-2ddbee626b49.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat tert-butyl methacrylate,585-07-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66a285c1-8ac9-4831-8b0c-e56f103f148e/documents/IUC5-9f21fc85-e364-49b3-bede-adc85d270407_c32b39ab-f0ca-46b0-9aa4-2ddbee626b49.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,832 mg/m3",adverse effect observed,rat tert-butyl methacrylate,585-07-9,"Acute oral toxicity: EU Method B1 (modified according to the acute toxic class method), GLP compliant, K1 rat: LD50 > 2000 mg/kg bw Acute dermal toxicity: OECD 402, GLP compliant, K1, rat: LD50> 2000 mg/kg bw Acute inhalation toxicity: OECD 403, GLP compliant, K1, rat: LC50> 10.17 mg/L Studies conducted on the structural analoge nBMA support these findings. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP and guideline compliant study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): GLP and guideline compliant study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): GLP and guideline compliant study ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66a285c1-8ac9-4831-8b0c-e56f103f148e/documents/IUC5-f377d3c5-0b29-430d-9e56-3e6aec32a498_c32b39ab-f0ca-46b0-9aa4-2ddbee626b49.html,,,,,, tert-butyl methacrylate,585-07-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66a285c1-8ac9-4831-8b0c-e56f103f148e/documents/IUC5-f377d3c5-0b29-430d-9e56-3e6aec32a498_c32b39ab-f0ca-46b0-9aa4-2ddbee626b49.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, tert-butyl methacrylate,585-07-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66a285c1-8ac9-4831-8b0c-e56f103f148e/documents/IUC5-f377d3c5-0b29-430d-9e56-3e6aec32a498_c32b39ab-f0ca-46b0-9aa4-2ddbee626b49.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, tert-butyl methacrylate,585-07-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66a285c1-8ac9-4831-8b0c-e56f103f148e/documents/IUC5-f377d3c5-0b29-430d-9e56-3e6aec32a498_c32b39ab-f0ca-46b0-9aa4-2ddbee626b49.html,,inhalation,discriminating conc.,10.17 mg/L,no adverse effect observed, tert-butyl methyl ether,1634-04-4,"In animals, after inhalation and oral repeated exposure, the principal affected organs are liver and kidneys. Mostly these changes appeared after inhalation exposure to concentrations of 3000 ppm (10710 mg/m3) and above or at oral doses greater than 209 mg/kg bw/day (exposure via drinking water) or 300 mg/kg bw/day (exposure by gavage).The SCOEL has derived an 8-h TWA of 50 ppm (178.5 mg/m3) for inhalation exposure based on the available toxicity data.No dermal repeated dose toxicity studies are available.Human studies provided limited information on MTBE long-term-effects. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7aecd34-855c-4290-9d3c-7214ad130dc1/documents/IUC5-20f78310-44e0-40d2-955b-771bac892400_9425821f-eb46-4633-9188-ae1dfc66f288.html,,,,,, tert-butyl methyl ether,1634-04-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7aecd34-855c-4290-9d3c-7214ad130dc1/documents/IUC5-20f78310-44e0-40d2-955b-771bac892400_9425821f-eb46-4633-9188-ae1dfc66f288.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,209 mg/kg bw/day,,rat tert-butyl methyl ether,1634-04-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7aecd34-855c-4290-9d3c-7214ad130dc1/documents/IUC5-20f78310-44e0-40d2-955b-771bac892400_9425821f-eb46-4633-9188-ae1dfc66f288.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"2,856 mg/m3",,rat tert-butyl methyl ether,1634-04-4," MTBE exhibits low acute toxicity via oral, dermal and inhalation in humans and test animals. In rats, the average oral LD50 is about 4000 mg/kg bw. The dermal LD50 is over 2000 mg/kg bw in rats and over 10000 mg/kg bw in rabbits. For inhalation, an LC50 of approximately 85 mg/l has been determined. In animals, the most typical effect at high exposures is decreased ability for muscle coordination and hypoactivity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7aecd34-855c-4290-9d3c-7214ad130dc1/documents/IUC5-c615f74f-86c0-4b20-82e5-9fbe5305c173_9425821f-eb46-4633-9188-ae1dfc66f288.html,,,,,, tert-butyl methyl ether,1634-04-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7aecd34-855c-4290-9d3c-7214ad130dc1/documents/IUC5-c615f74f-86c0-4b20-82e5-9fbe5305c173_9425821f-eb46-4633-9188-ae1dfc66f288.html,,inhalation,LC50,"85,000 mg/m3",, N-tert-butylacrylamide,107-58-4,"Repeated dose toxicity OECD 407: NOAEL in male rats was considered at 500 mg/kg. The observed effects in female rats treated at 500 mg/kg in the main study included significant decreases in body weight gain and indications of minor kidney toxicity. These effects were considered to be reversible based on lack of similar effects in the recovery groups of female rats treated at 500 mg/kg. The observed effects in female rats treated at 500 mg/kg in the main study were considered adverse and only reversible upon cessation of treatment. NOAEL in female rats was therefore considered at 250 mg/kg. OECD 408: NOAEL in male rats was considered to be 120 mg/kg bw/day, based on clinical signs of toxicity (lethargy) and significant decreases in body weight and body weight gain at 450 mg/kg bw/day. NOAEL in female rats was considered to be 450 mg/kg bw/day, as no adverse effects were observed at this dose level in the female rats. Repeated dose toxicity- Inhalation route According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the particle size distribution of N-tert-butylacrylamide and that the exposure via the inhalation route is unlikely, this end point was considered for waiver.   Repeated dose toxicity- Dermal route The acute toxicity value for N-tert-butylacrylamide (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Hence this end point was considered for waiver. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch 1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14f7e4ee-6dce-4b18-8d85-79b5ae32ba25/documents/eff3fcb8-1426-4335-8885-a0d57b483205_38418fa8-fc15-4c21-8940-871c20972321.html,,,,,, N-tert-butylacrylamide,107-58-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14f7e4ee-6dce-4b18-8d85-79b5ae32ba25/documents/eff3fcb8-1426-4335-8885-a0d57b483205_38418fa8-fc15-4c21-8940-871c20972321.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat N-tert-butylacrylamide,107-58-4," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on mice for the given test chemical. The LD50 value is 914 mg/kg bw. The studies concluded that the LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to low vapour pressure of the test chemical, which is reported to be 0.385 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on study conducted on rats for the test chemical. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14f7e4ee-6dce-4b18-8d85-79b5ae32ba25/documents/9d6afeee-5b08-4a2e-ae0e-7136ece1a09f_38418fa8-fc15-4c21-8940-871c20972321.html,,,,,, N-tert-butylacrylamide,107-58-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14f7e4ee-6dce-4b18-8d85-79b5ae32ba25/documents/9d6afeee-5b08-4a2e-ae0e-7136ece1a09f_38418fa8-fc15-4c21-8940-871c20972321.html,,oral,LD50,941.174 mg/kg bw,adverse effect observed, N-tert-butylacrylamide,107-58-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14f7e4ee-6dce-4b18-8d85-79b5ae32ba25/documents/9d6afeee-5b08-4a2e-ae0e-7136ece1a09f_38418fa8-fc15-4c21-8940-871c20972321.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-tert-butylaminoethyl methacrylate,3775-90-4,"The only repeat dose study available on 2-tert-butylaminethyl methacrylate is an OECD 422 repeated dose toxicity oral study, via the drinking water.  The NOAEL from this study can also be used to calculate DNELs for the dermal and inhalation routes.   Testing is not scientifically justified for these routes due to the corrosive properties of 2-tert-butylaminethyl methacrylate and the limited possibility of exposure by these routes in the workplace. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/931a48a0-0b97-45f9-bb39-d9448b5c94ba/documents/IUC5-79673c6f-f352-4642-a365-4e782fccd482_cac2ff65-272c-40d8-a7e1-9c70c3f561ca.html,,,,,, 2-tert-butylaminoethyl methacrylate,3775-90-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/931a48a0-0b97-45f9-bb39-d9448b5c94ba/documents/IUC5-79673c6f-f352-4642-a365-4e782fccd482_cac2ff65-272c-40d8-a7e1-9c70c3f561ca.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat 2-tert-butylaminoethyl methacrylate,3775-90-4,There is a Klimisch 1 acute oral toxicity study on 2-tert-butylaminoethyl methacrylate available.  Dermal and inhalation acute toxicity tests are not available and due to the corrosive properties of 2-tert-butylaminoethyl methacrylate it is not considered scientifically justified to carry out these studies. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/931a48a0-0b97-45f9-bb39-d9448b5c94ba/documents/IUC5-3aad6110-4540-469e-be61-a54c1e3be5df_cac2ff65-272c-40d8-a7e1-9c70c3f561ca.html,,,,,, 2-tert-butylaminoethyl methacrylate,3775-90-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/931a48a0-0b97-45f9-bb39-d9448b5c94ba/documents/IUC5-3aad6110-4540-469e-be61-a54c1e3be5df_cac2ff65-272c-40d8-a7e1-9c70c3f561ca.html,,oral,LD50,"1,400 mg/kg bw",adverse effect observed, "N,N'-ethylenebis[N-acetylacetamide]",10543-57-4,"The repeated dose toxicity of TAED in the rat has been evaluated following the oral, dermal and inhalation exposure route. A NOAEL of 90 mg/kg bw/d was deduced from the 90-day oral gavage studies. The NOAEL in the 90-d dermal toxicity study was 2000 mg/kg bw/d. 90-day repeated exposure by inhalation to TAED dust at doses up to 99.7 mg/m³ did not cause any adverse effects in the rat lung, respiratory tract or nasal mucosa. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/435c4e5b-5d5e-493e-a699-b2a68096db29/documents/IUC5-4cf2952d-a704-44ed-8a0c-0338f89f00c3_71c9a592-5422-456a-ac8e-0a5163560694.html,,,,,, "N,N'-ethylenebis[N-acetylacetamide]",10543-57-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/435c4e5b-5d5e-493e-a699-b2a68096db29/documents/IUC5-4cf2952d-a704-44ed-8a0c-0338f89f00c3_71c9a592-5422-456a-ac8e-0a5163560694.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,90 mg/kg bw/day,, "N,N'-ethylenebis[N-acetylacetamide]",10543-57-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/435c4e5b-5d5e-493e-a699-b2a68096db29/documents/IUC5-4cf2952d-a704-44ed-8a0c-0338f89f00c3_71c9a592-5422-456a-ac8e-0a5163560694.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",, "N,N'-ethylenebis[N-acetylacetamide]",10543-57-4,LD50 (oral) in rats: in the range of 8000 mg/kg bw (no lethality occurred at a dose of 2000 mg/kg bw)LD50 (dermal) in rats: > 2000 mg/kg bw (no substance related mortality)LC50 (inhalation) in the rat: no mortality at 2.08 mg/L/4 h (= the highest TAED exposure concentration tested) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/435c4e5b-5d5e-493e-a699-b2a68096db29/documents/IUC5-a06c504d-2d7f-4cf1-beba-632bc18ecbb8_71c9a592-5422-456a-ac8e-0a5163560694.html,,,,,, "Tagetes minuta, ext.",91770-75-1," In an acute oral toxicity study (OECD 425) on rats, the Oral LD50 was higher than 5000 mg/kg (GLP study, Rel. K1) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/550cef9d-f865-4ed6-97a8-dc37fb8e105e/documents/31fbd044-90c1-48f7-86e9-e4402fa32424_6289b35c-944d-4282-9a2b-8e269ca3e3b2.html,,,,,, "Tagetes minuta, ext.",91770-75-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/550cef9d-f865-4ed6-97a8-dc37fb8e105e/documents/31fbd044-90c1-48f7-86e9-e4402fa32424_6289b35c-944d-4282-9a2b-8e269ca3e3b2.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Talc (Mg3H2(SiO3)4),14807-96-6,"Oral repeated dose toxicity For a period of 101 days for male and female rats, the NOAEL of Talc in a feeding study was 100 mg/kg/day. No adverse effects were seen on general toxicity endpoints. One of the animals treated with talc showed a leiomyosarcoma of the stomach. Sarcomas, which were however not associated with the talc treatment, were found in the uterus of two animals. No chronic pathological effect was associated with oral administration of Italian talc (92% pure; 100 mg per day on 101 days over 5 months) to rats.   Inhalation repeated dose toxicity F344 rats and B6C3F1 mice were exposed to talc by inhalation for 20 days. The concentrations were 0, 2, 6, and 18 mg/m3. The animals were exposed for 6 hours a day and 5 days per week. Lung burdens in rats increased from 70 µg talc/g lung in the 2 mg/m3 group to 720 µg talc/g lung in the 18 mg/m3 group. The histopathological examinations after 20 days of exposure did not show any exposure-induced lesions in the highest exposure group so that the specimens of the lower exposure groups were not examined.   Dermal repeated dose toxicity No studies were located regarding long term exposure local effects in animals after dermal exposure to talc   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b979cea5-19f2-4dce-86fb-dec37edcff04/documents/e93c7370-262b-4330-99af-12e2255efcb5_8a72c655-593b-4fcd-b079-929fda602998.html,,,,,, Talc (Mg3H2(SiO3)4),14807-96-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b979cea5-19f2-4dce-86fb-dec37edcff04/documents/e93c7370-262b-4330-99af-12e2255efcb5_8a72c655-593b-4fcd-b079-929fda602998.html,Chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Talc (Mg3H2(SiO3)4),14807-96-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b979cea5-19f2-4dce-86fb-dec37edcff04/documents/e93c7370-262b-4330-99af-12e2255efcb5_8a72c655-593b-4fcd-b079-929fda602998.html,Chronic toxicity – systemic effects,dermal,NOAEL,2.5 mg/kg bw/day,,rat Talc (Mg3H2(SiO3)4),14807-96-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b979cea5-19f2-4dce-86fb-dec37edcff04/documents/e93c7370-262b-4330-99af-12e2255efcb5_8a72c655-593b-4fcd-b079-929fda602998.html,Chronic toxicity – systemic effects,inhalation,NOAEC,10.8 mg/m3,,rat Talc (Mg3H2(SiO3)4),14807-96-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b979cea5-19f2-4dce-86fb-dec37edcff04/documents/e93c7370-262b-4330-99af-12e2255efcb5_8a72c655-593b-4fcd-b079-929fda602998.html,Repeated dose toxicity – local effects,dermal,NOAEL,12.5 mg/cm2,no adverse effect observed,rat Talc (Mg3H2(SiO3)4),14807-96-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b979cea5-19f2-4dce-86fb-dec37edcff04/documents/e93c7370-262b-4330-99af-12e2255efcb5_8a72c655-593b-4fcd-b079-929fda602998.html,Repeated dose toxicity – local effects,inhalation,NOAEC,18 mg/m3,no adverse effect observed,rat Talc (Mg3H2(SiO3)4),14807-96-6,"Acute oral toxicity: The oral LD50 of 18.3% talc in saline was >5000 mg/kg. A single oral dose of 5000 mg/kg of talc prepared as an 18.3% (w/v) suspension in saline was administered to 10 male rats. All animals survived, and there were no signs of toxicity.   Acute dermal toxicity:   Talc is used as a cosmetic powder and to powder gloves. There are no indications of Acute toxicity dermal. The study is therefore considered scientifically unjustified. Therefore testing for Acute toxicity dermal does not need to be performed.   Pure talc has the formula Mg3Si4O10(OH)2 and a chemical composition of 31.88% by weight (wt) magnesium oxide (MgO), therefore the health effects of Magnesium chloride also should be taken into account.   Magnesium chloride has of relatively low acute toxicity ( LD50, dermal, rat: >2000 mg/kg bw day;   Acute inhalation toxicity:   There are no Acute toxicity studies available on the inhalative uptake of talc without asbestos fibres. There are no indications of Acute toxicity inhalation of talc without asbestos fibres. The study is therefore considered scientifically unjustified. Therefore testing for Acute toxicity inhalation does not need to be performed.   Pure talc has the formula Mg3Si4O10(OH)2 and a chemical composition of 31.88% by weight (wt) magnesium oxide (MgO), therefore the health effects of Magnesium hydroxide also should be taken into account   Magnesium hydroxide has of relatively low acute toxicity (LC50, inhalation, rat: 2100 mg/m3);   It is concluded that the substanceTalc (Mg3H2(SiO3)4) does not meet the criteria to be classified for human health hazards for Acute dose toxicity.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b979cea5-19f2-4dce-86fb-dec37edcff04/documents/8c45a549-6048-439e-a134-168e10e463b4_8a72c655-593b-4fcd-b079-929fda602998.html,,,,,, Talc (Mg3H2(SiO3)4),14807-96-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b979cea5-19f2-4dce-86fb-dec37edcff04/documents/8c45a549-6048-439e-a134-168e10e463b4_8a72c655-593b-4fcd-b079-929fda602998.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Talc (Mg3H2(SiO3)4),14807-96-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b979cea5-19f2-4dce-86fb-dec37edcff04/documents/8c45a549-6048-439e-a134-168e10e463b4_8a72c655-593b-4fcd-b079-929fda602998.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Talc (Mg3H2(SiO3)4),14807-96-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b979cea5-19f2-4dce-86fb-dec37edcff04/documents/8c45a549-6048-439e-a134-168e10e463b4_8a72c655-593b-4fcd-b079-929fda602998.html,,inhalation,LC50,"2,100 mg/m3",no adverse effect observed, Tall oil,8002-26-4," Based on available data for groups of constituents present in Distilled Tall Oil, a conservative 2-year NOAEL of >200 mg/kg/d is set for the oral route. An OECD 422 Combined Repeated Dose Toxicity Study with Reproductive/ Developmental Toxicity Screening Study is available for Distilled Tall Oil via the oral route in the diet for Sprague-Dawley rats (Inveresk Research, 2002e). The test was carried out according to the requirements of the guideline and in compliance with GLP. Effects on organ weights and clinical chemistry were observed at 5000 and 20,000 ppm in the diet, and decreased food consumption was also seen at the highest dose level, 20,000 ppm. A NOEL of 1000 ppm in the diet was established for general systemic toxicity in the study. Based on mean body weight and food consumption data over the duration of the study, this is equivalent to approximately 83 mg/kg/d for males and 100 mg/kg/d for females. In a recently conducted OECD 408 repeated dose toxicity study in the rat (Charles River, 2020), administration of Tall Oil by dietary administration for at least 90 days was well tolerated in rats at levels up to 15,000 ppm and did not result in any adverse test item related (morphologic) alterations. Based on these results, the no-observed-adverse-effect level (NOAEL) was considered to be 15,000 ppm. This dietary level was equivalent to an overall mean daily intake of 1104 mg/kg/d in males and 1221 mg/kg/d in females. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5502145-7391-43b3-9e86-feb990c1c55f/documents/7a4660b1-d412-4155-a9e2-32a9b2e6dfeb_52f5e4ba-e441-46b4-a49b-4bd16bae2b10.html,,,,,, Tall oil,8002-26-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5502145-7391-43b3-9e86-feb990c1c55f/documents/7a4660b1-d412-4155-a9e2-32a9b2e6dfeb_52f5e4ba-e441-46b4-a49b-4bd16bae2b10.html,Chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Tall oil,8002-26-4," No acute toxicity data are available for Distilled Tall Oil. Good quality, guideline studies for the related substance Crude Tall Oil are therefore read across. The key acute oral toxicity study gave an LD50 (oral) >2000 mg/kg bw (OECD 423, acute toxic class method) in rats (ARC, 2005a). There were no clinical signs or necropsy findings. The key acute dermal toxicity study gave an LD50 (dermal) >2000 mg/kg bw (OECD 402, limit test) in rats (ARC, 2005b). There were no clinical signs, signs of local irritation or necrospy findings. These values are read across to the registered substance, Distilled Tall Oil. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5502145-7391-43b3-9e86-feb990c1c55f/documents/711c1d38-eff6-49fc-88cc-659ae614d84c_52f5e4ba-e441-46b4-a49b-4bd16bae2b10.html,,,,,, Tall oil,8002-26-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5502145-7391-43b3-9e86-feb990c1c55f/documents/711c1d38-eff6-49fc-88cc-659ae614d84c_52f5e4ba-e441-46b4-a49b-4bd16bae2b10.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tall oil,8002-26-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5502145-7391-43b3-9e86-feb990c1c55f/documents/711c1d38-eff6-49fc-88cc-659ae614d84c_52f5e4ba-e441-46b4-a49b-4bd16bae2b10.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Glycerides, tall-oil mono-, di-, and tri-",97722-02-6,"Studies on oral repeated dose toxicity were available for the following Category members (CAS No.): 73398-61-5, 8001-79-4, 91845 -19-1 and for medium- and long-chain triglyceride mixtures. All available studies resulted in oral NOAELs of 1000 mg/kg bw/d or greater than 1000 mg/kg bw/d.Studies on dermal repeated dose toxicity were available for the following Category member (CAS No.): 73398-61-5.A subacute (28 days) dermal NOAEL of 2000 mg/kg bw/d for rabbits was reported. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/961d5e3b-cc61-4a85-95e9-116b7725f794/documents/IUC5-62e3c794-fa3c-4442-8aab-7dd2eaf6380c_739b9956-31ef-42e5-acc0-f9aa03a700ae.html,,,,,, "Glycerides, tall-oil mono-, di-, and tri-",97722-02-6,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/961d5e3b-cc61-4a85-95e9-116b7725f794/documents/IUC5-10d75d70-87b2-49ae-9752-ad7c9a8456c3_739b9956-31ef-42e5-acc0-f9aa03a700ae.html,,,,,, "1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-nortall-oil alkyl derivs.",61791-39-7," The oral administration of 1-(2-Hydroxyethyl)-2-Tall Oil-2-Imidazoline to rats by gavage, at dose levels of 15, 30 and 60 mg/kg bw/day, resulted in local irritant gastric irritation in all treatment groups. Therefore, a no observed-effect-level NOEL for local irritant effects can only be claimed for 15 mg/kg bw/day males. However, in relation to systemic and reproductive toxicity in the absence of any toxicologically significant effects the NOEL was considered to be 60 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac2e3d57-62d8-460a-accd-31936393f3fb/documents/IUC5-7d8a9ccc-4b9a-475b-9f30-6c1aab511fce_b02d2320-d07b-4097-bd9c-040480b61816.html,,,,,, "1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-nortall-oil alkyl derivs.",61791-39-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac2e3d57-62d8-460a-accd-31936393f3fb/documents/IUC5-7d8a9ccc-4b9a-475b-9f30-6c1aab511fce_b02d2320-d07b-4097-bd9c-040480b61816.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat "1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-nortall-oil alkyl derivs.",61791-39-7," The acute oral median lethal dose, (LD50) of the test material, in the Sprague-Dawley CD strain rat, was estimated as being greater than 2500 mg/kg bodyweight. Under the conditions of the study, the acute dermal LD50 of the test material is considered to be greater than 2000 mg/kg body weight. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac2e3d57-62d8-460a-accd-31936393f3fb/documents/IUC5-06e52bc2-d2a5-445e-bffa-f62fd412fe02_b02d2320-d07b-4097-bd9c-040480b61816.html,,,,,, "1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-nortall-oil alkyl derivs.",61791-39-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac2e3d57-62d8-460a-accd-31936393f3fb/documents/IUC5-06e52bc2-d2a5-445e-bffa-f62fd412fe02_b02d2320-d07b-4097-bd9c-040480b61816.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, "1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-nortall-oil alkyl derivs.",61791-39-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac2e3d57-62d8-460a-accd-31936393f3fb/documents/IUC5-06e52bc2-d2a5-445e-bffa-f62fd412fe02_b02d2320-d07b-4097-bd9c-040480b61816.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amides, tall-oil fatty, N-[3-(dimethylamino)propyl]",68650-79-3,"In a 28-day repeated dose oral toxicity study conducted according to the OECD Guideline 407 and in compliance with GLP, the No Observed Adverse Effect Level (NOAEL) of N-[3-(dimethylamino)propyl]-C18 unsaturated-alkylamide (unsaturated C18) was considered to be 150 mg/kg bw/day in rats. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/d53008be-cda9-4011-bb5d-6e1f963b114b/documents/46d0c5b3-6e34-4254-b6af-7011c9a6d047_68a66e47-76b6-41e3-ba11-e776cb451291.html,,,,,, "Amides, tall-oil fatty, N-[3-(dimethylamino)propyl]",68650-79-3,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/d53008be-cda9-4011-bb5d-6e1f963b114b/documents/46d0c5b3-6e34-4254-b6af-7011c9a6d047_68a66e47-76b6-41e3-ba11-e776cb451291.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Amides, tall-oil fatty, N-[3-(dimethylamino)propyl]",68650-79-3,"One key acute oral toxicity study is available. The study was conducted according to OECD Guideline 401 and used rat Sprague-Dawley rats as the test species. The dose-level of 2000 mg/kg of N-[3-(dimethylamino)propyl]-C18 unsaturated-alkylamide (unsaturated C18) was estimated to be the oral median lethal dose, LD50 in rats. No studies are available for acute inhalation or dermal toxicity. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d53008be-cda9-4011-bb5d-6e1f963b114b/documents/b18cc8c4-6d19-499a-9ec4-6de53cf1a926_68a66e47-76b6-41e3-ba11-e776cb451291.html,,,,,, "Amides, tall-oil fatty, N-[3-(dimethylamino)propyl]",68650-79-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d53008be-cda9-4011-bb5d-6e1f963b114b/documents/b18cc8c4-6d19-499a-9ec4-6de53cf1a926_68a66e47-76b6-41e3-ba11-e776cb451291.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, (+)-tartaric acid,87-69-4,Tartaric acid and its salts do not have significant (sub)chronic toxicity. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0cdd8531-8acb-469b-a934-c2de6fc6d515/documents/a8154d92-0ea3-4a9e-bb9f-d5c94deae7ff_46ddfeb6-acd0-42f2-951b-0002faf934f1.html,,,,,, (+)-tartaric acid,87-69-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0cdd8531-8acb-469b-a934-c2de6fc6d515/documents/a8154d92-0ea3-4a9e-bb9f-d5c94deae7ff_46ddfeb6-acd0-42f2-951b-0002faf934f1.html,Chronic toxicity – systemic effects,oral,NOAEL,"2,460 mg/kg bw/day",,rat (+)-tartaric acid,87-69-4,Tartaric acid and its salts does not have significant acute toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0cdd8531-8acb-469b-a934-c2de6fc6d515/documents/82d1b843-0a17-4774-a178-42d18a1b18a7_46ddfeb6-acd0-42f2-951b-0002faf934f1.html,,,,,, (+)-tartaric acid,87-69-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0cdd8531-8acb-469b-a934-c2de6fc6d515/documents/82d1b843-0a17-4774-a178-42d18a1b18a7_46ddfeb6-acd0-42f2-951b-0002faf934f1.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Taurine,107-35-7," The results of this sub-chronic study in rats provided further useful information in that it showed no significant changes in pathological measures, no persistent effects on body weight or food consumption and no histopathological changes in organs or tissues in any dose group, but it did show the occurrence of significant behavioural effects (increased activity and self-chewing), and possibly impaired motor performance, which could be mediated via a pharmacological action on the central nervous system. These results show that 1000 mg/kg bw/day is a clear effect level for behavioural changes while the lower doses of 300 and 600 mg/kg bw/day are marginal effect levels in males but clear effect levels in females. Thus, a NOAEL for behavioural effects in rats has not been established. Therefore, a GLP-and OECD-compliant neurotoxicity study was conducted (please see chapter 7.9.1). Based on these results no compound-related effects were reported at any dose with respect to locomotor activity testing or FOB parameters (including home cage, handling, open field, sensory, neuromuscular, or physiological observations). EFSA (2009) concluded that the results of this study are sufficient to address the behavioral concerns previously raised, and provide evidence for a NOAEL of 1,000 mg/kg body weight/day in the original toxicity study (i.e., WIL, 2001 ). A NOAEL of 1 ,656 mg/kg body weight was determined based on a lack of adverse physiological or behavioral effects following this 13 week exposure via drinking water in the follow-up neurological study. Exposure to taurine is unavoidable as it is a natural constituent of the body and is present in foods of animal origin. Spitze et al. (2003) determined the taurine content of a variety of foodstuffs. Animal muscle tissue, particularly fish flesh, contained high concentrations of taurine. The mean daily exposure to taurine from omnivore diets has been estimated to range from 9–40 (lowest range values) to up to 200–400 mg/person per day (top range values) (Rana and Sanders, 1986; Laidlaw et al., 1990; Hayes and Trautwein, 1994). The EFSA FEEDAP Panel estimates the Observed Safe Limit (OSL) in humans to be 6 g/person per day (corresponding to 100 mg/kg bw per day). Exposure resulting from the consumption of foodstuffs and ""energy drinks"" together would amount to about one-third of the OSL. The highest, as well as the most recent, of the top range estimates is 400 mg/person per day (Hayes and Trautwein, 1994), equal to 6.7 mg/kg bw per day for a 60-kg person. This value is 150 times lower than the NOAEL of 1000 mg/kg bw per day in laboratory animals and 15 times lower than the human OSL (100 mg/kg bw per day). Furthermore, taurine is used in more than 30 clinical investigations in humans in conditions including diabetes, epilepsy, congestive heart failure, hypertension, liver disease and cystic fibrosis, concluding that “No adverse health effects attributable to taurine have been reported over a period of 30 years. In many cases taurine has proved medically beneficial.” Literature: Hayes KC and Trautwein EA, 1994. Modern nutrition in health and disease. In: Taurine. Lea & Febiger, Philadelphia, 477–485 (cited in the SCF opinion 1999). Laidlaw SA, Grosvenor M and Koppele JD, 1990. The taurine content of common foodstuffs. Journal of Parenteral and Enteral Nutrition, 14, 183–188. Spitze AR, Wong DL, Rogers QR and Fascetti AJ, 2003. Taurine concentrations in animal feed ingredients; cooking influences taurine content. Journal of Animal Physiology and Animal Nutrition, 87, 251–262. Rana SK and Sanders TAB, 1986. Taurine concentrations in the diet, plasma and breast milk of vegans compared with omnivores. British Journal of Nutrition, 56, 17–27. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a9e25fc-7dce-4f45-a5d7-ac22053e5269/documents/c406410e-e084-4c36-8e73-1d8da2a38eed_9a043e9e-5f83-40fd-9cdf-e93331ce53d0.html,,,,,, Taurine,107-35-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a9e25fc-7dce-4f45-a5d7-ac22053e5269/documents/c406410e-e084-4c36-8e73-1d8da2a38eed_9a043e9e-5f83-40fd-9cdf-e93331ce53d0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Taurine,107-35-7, OECD 401: LD50 > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a9e25fc-7dce-4f45-a5d7-ac22053e5269/documents/1b6c6663-d86d-47b3-98c7-c1fcb498085f_9a043e9e-5f83-40fd-9cdf-e93331ce53d0.html,,,,,, Taurine,107-35-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a9e25fc-7dce-4f45-a5d7-ac22053e5269/documents/1b6c6663-d86d-47b3-98c7-c1fcb498085f_9a043e9e-5f83-40fd-9cdf-e93331ce53d0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-tert-butylhydroquinone,1948-33-0," Repeated dose toxicity: Oral The cumulative toxic effects of the test chemical in rats were evaluated in the 13 week study. The test substance was administered in diet to male and female F344/N rats at a dose level of 0, 2500, 5000 or 10000 ppm for 13 weeks after weaning. This dose level is equivalent to a daily dose of approximately 0, 200, 400 or 800 mg/kg bw for males and 0, 200, 400 or 750 mg/kg bw for females. The following parameters were evaluated: body weight and feed consumption, hematology, clinical chemistry and coagulation analysis, sperm motility and vaginal cytology. A complete histopathological examination was conducted. The LOAEL value of 2-tert-butylhydroquinone was found to be 200 mg/kg/day in female rats due to effect on length ofestrous cycles. The NOAEL value in male rats was determined to be 200 mg/kg/day, based on no effects observed during analysis of body weight, feed consumption and sperm parameters. At various time points there were increases in serum bile acid levels and serum alanine aminotransferase activity levels in male and female rats exposed to the test chemical. Such increases are generally associated with liver toxicity and since histopathologic evaluation did not reveal any evidence of liver toxicity, these marginal increases were not considered to be biologically significant. The effects of the test chemical on reproductive parameters in male rats were observed only at dose level of 5000 ppm. Histopathologic changes were observed in rats exposed to 5000 or 10000 ppm the test chemical which included increased incidences of nasal respiratory epithelial hyperplasia, nasal exudate (males only), splenic pigmentation, splenic atrophy of the red pulp (females only), and kidney mineralization (females only).   Repeated dose toxicity: Inhalation This end point was considered for waiver considering that the vapor pressure of 2-tert-butylhydroquinone (CAS no 1948-33-0) is not high i.e. 0.00112 mm Hg and also in accordance with column 1 of Annex IX, this end point was considered for waiver since the details for acute toxicity by the inhalation route have already been provided as part of the Annex VII requirements of the REACH regulation in section 7.2.2 of this dossier. Repeated dose toxicity: Dermal The test chemical was tested at concentrations of 0.1, 1.0 and 5.0%. Groups of five males and five females of black guinea pigs were dosed with the test chemical or the vehicle (hydrophilic ointment) daily (M-F) for 13 weeks. The application site was evaluated weekly for degree of pigmentation loss and irritation. Twenty-four hours after final application, sites were evaluated for depigmentation, irritation and hyperpigmentation. Subsequently, the application site was depilated and re-evaluated for the same endpoints. Repetitive exposure to concentrations of 1.0% and 5.0% were slightly to moderately irritating, while 0.1% produced only weak irritant response. No irritant responses to hydrophilic ointment were observed. 0.1% produced depigmentation, while 20% of animals dosed with 1.0% had spotty or uniform loss of pigment at the site of treatment. Approximately 40% of animals dosed with 5% were depigmented at the treatment site at the final evaluation.The study showed that the test chemical causes depigmentation in black guinea pigs at concentrations of 1% or greater, but that a no-effect threshold for this endpoint exists at a concentration between 0.1 and 1.0%. Hence NOAEL was assessed to be 0.1% (1000 mg/kg) and LOAEL was assessed to be 1% (10000 mg/kg). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/469d34b0-287a-4e0a-8e29-1f98090e6df7/documents/d1705840-626f-4f55-9678-f9fe259bb002_24091945-9a39-4fc5-a843-ca432e2e8b7a.html,,,,,, 2-tert-butylhydroquinone,1948-33-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/469d34b0-287a-4e0a-8e29-1f98090e6df7/documents/d1705840-626f-4f55-9678-f9fe259bb002_24091945-9a39-4fc5-a843-ca432e2e8b7a.html,Chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat 2-tert-butylhydroquinone,1948-33-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/469d34b0-287a-4e0a-8e29-1f98090e6df7/documents/d1705840-626f-4f55-9678-f9fe259bb002_24091945-9a39-4fc5-a843-ca432e2e8b7a.html,Chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,guinea pig 2-tert-butylhydroquinone,1948-33-0," Acute oral toxicity:    The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute oral toxicity class IV.   Acute Inhalation Toxicity:   The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.00144 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity:   The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is between 200-1000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute dermal toxicity class IV. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/469d34b0-287a-4e0a-8e29-1f98090e6df7/documents/29e96a5a-6c54-4c5c-bdb2-d459fab9d6a3_24091945-9a39-4fc5-a843-ca432e2e8b7a.html,,,,,, 2-tert-butylhydroquinone,1948-33-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/469d34b0-287a-4e0a-8e29-1f98090e6df7/documents/29e96a5a-6c54-4c5c-bdb2-d459fab9d6a3_24091945-9a39-4fc5-a843-ca432e2e8b7a.html,,oral,LD50,951 mg/kg bw,no adverse effect observed, 2-tert-butylhydroquinone,1948-33-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/469d34b0-287a-4e0a-8e29-1f98090e6df7/documents/29e96a5a-6c54-4c5c-bdb2-d459fab9d6a3_24091945-9a39-4fc5-a843-ca432e2e8b7a.html,,dermal,LD50,"1,000 mg/kg bw",no adverse effect observed, "Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)",22919-56-8," Acute toxicity studies for the substance, Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) have not been conducted as per Annex VII, as this substance is classified as corrosive to skin. However, literature data is available for 2,2',2''-nitrilotriethanol, which is reacted with Octanoic acid to form Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1), within the cosmetic ingredient review safety assessment, which shows that this substance is not classified as acutely toxic according to the GHS criteria. This report concluded that TEA and various TEA containing ingredients are safe for use in cosmetics and therefore the TEA salt, Octanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) would also be expected to be non-toxic. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca90fb25-d61a-46fc-90df-f32504aed74f/documents/2aaf0ef1-42c3-49c8-be1f-ce5b8722e123_df21bc4a-b524-4d14-b277-69bed6507f14.html,,,,,, "L-Glutamic acid, N-coco acyl derivs., compds. with triethanolamine (1:1)",68187-29-1," Based on the modelled conditions, the subacute NOEL of the test material in the rat was determined to be ca. 1080 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/87e5ee26-35f3-493f-998b-5322b85fdf92/documents/0a38fef0-aac8-4575-ae83-504045d42377_bbb15aef-41fa-4a89-9d6b-ab67e8f6f855.html,,,,,, "L-Glutamic acid, N-coco acyl derivs., compds. with triethanolamine (1:1)",68187-29-1," Acute Oral Key Study (Read-Across, Kiss, 2011) Under the conditions of the study, no signs of acute toxicity were observed, and it can be concluded that the acute oral LD50 is greater than 2000 mg/kg bw. Acute Oral Key Study (Read-Across, Masuyama, 2008) Under the conditions of the test, the acute oral LD50 was > 5.0 g/kg body weight and < 10.0 g/kg body weight. Acute Oral Supporting Study (Muroi, 1971) Under the conditions of the study the LD50 value of the test material was estimated to be 6.50 g/kg bw (95 % Confidence limit: 5.66 – 7.48 g/kg). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87e5ee26-35f3-493f-998b-5322b85fdf92/documents/f5593f5f-f916-4c16-a92d-085395f27ac5_bbb15aef-41fa-4a89-9d6b-ab67e8f6f855.html,,,,,, "L-Glutamic acid, N-coco acyl derivs., compds. with triethanolamine (1:1)",68187-29-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87e5ee26-35f3-493f-998b-5322b85fdf92/documents/f5593f5f-f916-4c16-a92d-085395f27ac5_bbb15aef-41fa-4a89-9d6b-ab67e8f6f855.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine, compound with 2,2',2''-nitrilotri(ethanol) (1:1)",17736-08-2," Oral (OECD 423/EU Method B.1), rats: LD50 > 2000 mg/kg bw (LD50 cut-off value = 2500 mg/kg bw) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e61da013-dff8-4574-89e6-8d4b5c5d21a6/documents/58a26393-b51e-4777-be3e-5c2b7ed1d5ab_9ee2f864-fe3c-48ab-a22d-c638f1e7a2b3.html,,,,,, "Fatty acids, tall-oil, compds. with triethanolamine",68132-46-7, Based on the available data the NOAEL for repeated dose toxicity is 80 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3bb4344-8af7-4b36-b833-1ead11b76a6c/documents/1b483625-b9f0-4866-943a-15bf1a7b8163_1d8f4ad8-0f72-49f9-bda7-8fd6c6bc9bc4.html,,,,,, "Fatty acids, tall-oil, compds. with triethanolamine",68132-46-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3bb4344-8af7-4b36-b833-1ead11b76a6c/documents/1b483625-b9f0-4866-943a-15bf1a7b8163_1d8f4ad8-0f72-49f9-bda7-8fd6c6bc9bc4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat "Fatty acids, tall-oil, compds. with triethanolamine",68132-46-7, Acute Oral (Read-across from structurally similar substance) Under the conditions of this study the estimated acute oral LD50 for male and female rats treated with the test material was determined to be greater than 10.0 g/kg. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3bb4344-8af7-4b36-b833-1ead11b76a6c/documents/87c6f79d-7438-4347-835c-6027a97507c5_1d8f4ad8-0f72-49f9-bda7-8fd6c6bc9bc4.html,,,,,, "Fatty acids, tall-oil, compds. with triethanolamine",68132-46-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3bb4344-8af7-4b36-b833-1ead11b76a6c/documents/87c6f79d-7438-4347-835c-6027a97507c5_1d8f4ad8-0f72-49f9-bda7-8fd6c6bc9bc4.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Terephthalaldehyde,623-27-8,The oral LD50 value of the test item in Wistar Han rats was established to exceed 2000 mg/kg body weight. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3984e9f9-672b-497c-b163-e0a7235589c2/documents/fe7cc51f-9dbb-4d17-b627-9e3910606887_42ae67b0-c256-4cd4-b109-41ab02614cc4.html,,,,,, Terephthalaldehyde,623-27-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3984e9f9-672b-497c-b163-e0a7235589c2/documents/fe7cc51f-9dbb-4d17-b627-9e3910606887_42ae67b0-c256-4cd4-b109-41ab02614cc4.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, terpene processing by-products",68956-56-9,"Terpinolene multiconstituent (OECD guideline 422 in rats by diet): NOAEL for systemic toxicity = 7500 ppm (equivalent to mean achieved dosage of 435.8 mg/kg bw /day), highest dose tested.Alpha pinene (90-day inhalation study in mice): NOAEC for systemic toxicity = 50 ppm (equivalent to 283.24 mg/m3)Camphene (OECD guideline 407 in rats by oral gavage): NOAEL for systemic toxicity = 250 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f0fa0aa-dad5-4458-927a-82e13980edb2/documents/IUC5-c1b56b37-4458-4267-a381-20dda11aae0e_872f95f7-2571-4274-b121-21682e1e3386.html,,,,,, "Hydrocarbons, terpene processing by-products",68956-56-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f0fa0aa-dad5-4458-927a-82e13980edb2/documents/IUC5-c1b56b37-4458-4267-a381-20dda11aae0e_872f95f7-2571-4274-b121-21682e1e3386.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,435.8 mg/kg bw/day,,rat "Hydrocarbons, terpene processing by-products",68956-56-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f0fa0aa-dad5-4458-927a-82e13980edb2/documents/IUC5-c1b56b37-4458-4267-a381-20dda11aae0e_872f95f7-2571-4274-b121-21682e1e3386.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,283.24 mg/m3,,mouse "Hydrocarbons, terpene processing by-products",68956-56-9,"In an acute oral toxicity study performed according to OECD guideline 401 and GLP compliant, LD50 > 2000 mg/kg bwIn acute dermal toxicity limit tests performed according to OECD guideline 402 and GLP compliant, LD50 > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f0fa0aa-dad5-4458-927a-82e13980edb2/documents/IUC5-68de4e33-c40b-40a5-9b13-c429ac6bba16_872f95f7-2571-4274-b121-21682e1e3386.html,,,,,, "Hydrocarbons, terpene processing by-products",68956-56-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f0fa0aa-dad5-4458-927a-82e13980edb2/documents/IUC5-68de4e33-c40b-40a5-9b13-c429ac6bba16_872f95f7-2571-4274-b121-21682e1e3386.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, terpene processing by-products",68956-56-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f0fa0aa-dad5-4458-927a-82e13980edb2/documents/IUC5-68de4e33-c40b-40a5-9b13-c429ac6bba16_872f95f7-2571-4274-b121-21682e1e3386.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "p-mentha-1,4(8)-diene",586-62-9,An oral diet repeated dose toxicity study (combined with a reproduction/developmental toxicity screening test) was conducted with terpinolene monoconstituent according to OECD Guideline No 422 and in compliance with GLP.The NOAEL (No Observed Adverse Effect Level) for systemic toxicity was determined to be 2500 ppm for females (equivalent to 161.5 mg/kg bw/day) and 5000 ppm for males (equivalent to 294.6 mg/kg bw/day). A combined NOAEL for males and females was determined as 154.6 mg/kg bw/day and was used for risk assessment. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/493a15bc-f2bd-441e-b6ee-d734597ae095/documents/IUC5-931a221d-5a2b-4462-9175-a88970d72ea3_eca1b163-38d4-44e6-a76c-592a7ecdeb4a.html,,,,,, "p-mentha-1,4(8)-diene",586-62-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/493a15bc-f2bd-441e-b6ee-d734597ae095/documents/IUC5-931a221d-5a2b-4462-9175-a88970d72ea3_eca1b163-38d4-44e6-a76c-592a7ecdeb4a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,154.6 mg/kg bw/day,,rat "p-mentha-1,4(8)-diene",586-62-9,"In an acute oral toxicity study (similar to OECD Guideline No 401) performed in rats, the LD50 was 3740 mg/kg bw.In an acute dermal toxicity study (similar to OECD Guideline No 402) performed in rabbits, the LD50 was higher than 4300 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/493a15bc-f2bd-441e-b6ee-d734597ae095/documents/IUC5-6337c979-9f39-4af1-861e-f6f870ac4618_eca1b163-38d4-44e6-a76c-592a7ecdeb4a.html,,,,,, "p-mentha-1,4(8)-diene",586-62-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/493a15bc-f2bd-441e-b6ee-d734597ae095/documents/IUC5-6337c979-9f39-4af1-861e-f6f870ac4618_eca1b163-38d4-44e6-a76c-592a7ecdeb4a.html,,oral,LD50,"3,740 mg/kg bw",no adverse effect observed, "p-mentha-1,4(8)-diene",586-62-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/493a15bc-f2bd-441e-b6ee-d734597ae095/documents/IUC5-6337c979-9f39-4af1-861e-f6f870ac4618_eca1b163-38d4-44e6-a76c-592a7ecdeb4a.html,,dermal,LD50,"4,300 mg/kg bw",no adverse effect observed, "2-tert-butyl-1,4-dimethoxybenzene",21112-37-8,"Short-term oral toxicity:   OECD 422 (Rat)   NOAEL: Systemic Toxicity (males): 150 mg/kg bw/day (based on effects on body weight and body weight gain) Systemic Toxicity (females): 450 mg/kg bw/day Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): OECD Guideline 422 study in rats. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/194a5522-6e14-4e34-be13-31a00f148bae/documents/f34bf12b-4031-4e96-9e8a-f211e79f3a5c_ced34f9b-072c-4908-9f82-1c6bace52aca.html,,,,,, "2-tert-butyl-1,4-dimethoxybenzene",21112-37-8,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/194a5522-6e14-4e34-be13-31a00f148bae/documents/f34bf12b-4031-4e96-9e8a-f211e79f3a5c_ced34f9b-072c-4908-9f82-1c6bace52aca.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "2-tert-butyl-1,4-dimethoxybenzene",21112-37-8, Acute oral LD50 (Rat) >2000 mg/Kg bw ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/194a5522-6e14-4e34-be13-31a00f148bae/documents/6c973e3c-97b1-45dd-8089-b09f3d150f24_ced34f9b-072c-4908-9f82-1c6bace52aca.html,,,,,, "2-tert-butyl-1,4-dimethoxybenzene",21112-37-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/194a5522-6e14-4e34-be13-31a00f148bae/documents/6c973e3c-97b1-45dd-8089-b09f3d150f24_ced34f9b-072c-4908-9f82-1c6bace52aca.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetrabutylammonium bromide,1643-19-2,"Repeated dose toxicity: oral OECD 407 study: NOAEL in male and female rats was established at 1000 mg/kg bw/day (oral gavage). OECD 408 study: NOAEL in male rats was established at 30 mg/kg bw/day (low-dose). LOAEL in male rats was established at 120 mg/kg bw/day (mid-dose) based on significant changes in clinical chemistry (electrolyte levels) and histopathological findings in the kidneys (i.e. interstitial haemorrhage of minimal severity in 4 out of 10 males) at 120 mg/kg bw/day. NOAEL in female rats could not be determined due to significant changes in clinical chemistry (electrolyte levels) and significant changes in the functional observatory battery (indicative of hyperactivity) at 30 mg/kg bw/day (low-dose). Repeated dose toxicity: inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the particle size distribution of the substance the majority of the particles were found to be in the size of 150 micrometer to 106 micrometer which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely. Therefore this study is considered for waiver.   Repeated dose toxicity: dermal The acute toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that the test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that the test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch 1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64e9469f-a6bd-4aa2-b4b3-4953ae64c3b7/documents/9e51924c-e59a-4f08-91f2-04839d3859d7_60186277-08fe-450e-ae15-845e4ec63fc8.html,,,,,, Tetrabutylammonium bromide,1643-19-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64e9469f-a6bd-4aa2-b4b3-4953ae64c3b7/documents/9e51924c-e59a-4f08-91f2-04839d3859d7_60186277-08fe-450e-ae15-845e4ec63fc8.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,30 mg/kg bw/day,,rat Tetrabutylammonium bromide,1643-19-2,"Acute oral toxicity:  Acute oral toxicity dose (LD50) of test chemical was considered based on experimental study conducted on rats, the LD50 value was considered in between 300-2000 mg/kg bw in rats. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity.   Acute Inhalation toxicity:  The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account the low vapour pressure of the test substance, which is reported as 0.000000000796 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.   Acute Dermal Toxicity: Acute Dermal toxicity dose (LD50) for target chemical was considered based on experimental study conducted on rats, the value was considered to be >2000 mg/kg bw in rats. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64e9469f-a6bd-4aa2-b4b3-4953ae64c3b7/documents/5acc9c16-434a-45b7-b5ce-795fd8a79f93_60186277-08fe-450e-ae15-845e4ec63fc8.html,,,,,, Tetrabutylammonium bromide,1643-19-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64e9469f-a6bd-4aa2-b4b3-4953ae64c3b7/documents/5acc9c16-434a-45b7-b5ce-795fd8a79f93_60186277-08fe-450e-ae15-845e4ec63fc8.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, Tetrabutylammonium bromide,1643-19-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64e9469f-a6bd-4aa2-b4b3-4953ae64c3b7/documents/5acc9c16-434a-45b7-b5ce-795fd8a79f93_60186277-08fe-450e-ae15-845e4ec63fc8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetradecane,629-59-4, Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test – NOAEL ≥ 1000 mg/kg for rats (OECD 422) Repeated Dose Oral 90d - NOAEL ≥ 5000 mg/kg bw/day for rats (OECD 408) Repeated Dose Inhalation 90d – NOAEC ≥ 10400 mg/m3 for rats (similar to OECD TG 413) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48c11e6f-fa84-4db8-a825-e276dd146391/documents/c2ba504e-d3b4-45ba-84db-a0edfbde8445_dd0c5752-1525-4234-89e2-3e31131805d9.html,,,,,, Tetradecane,629-59-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48c11e6f-fa84-4db8-a825-e276dd146391/documents/c2ba504e-d3b4-45ba-84db-a0edfbde8445_dd0c5752-1525-4234-89e2-3e31131805d9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat Tetradecane,629-59-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48c11e6f-fa84-4db8-a825-e276dd146391/documents/c2ba504e-d3b4-45ba-84db-a0edfbde8445_dd0c5752-1525-4234-89e2-3e31131805d9.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"10,400 mg/m3",,rat Tetradecane,629-59-4, Acute Toxicity-Oral LD50 > 5000 mg/kg in rats (OECD TG 401) Acute Toxicity-Inhalation LC50 > 6100 mg/m3 (OECD TG 403) Acute Toxicity-Dermal LD50 > 3160 mg/kg in rabbits (OECD TG 402) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48c11e6f-fa84-4db8-a825-e276dd146391/documents/a291b4ed-b665-4c88-8666-a3862be46a0d_dd0c5752-1525-4234-89e2-3e31131805d9.html,,,,,, Tetradecane,629-59-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48c11e6f-fa84-4db8-a825-e276dd146391/documents/a291b4ed-b665-4c88-8666-a3862be46a0d_dd0c5752-1525-4234-89e2-3e31131805d9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Tetradecane,629-59-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48c11e6f-fa84-4db8-a825-e276dd146391/documents/a291b4ed-b665-4c88-8666-a3862be46a0d_dd0c5752-1525-4234-89e2-3e31131805d9.html,,dermal,LD50,"3,160 mg/kg bw",no adverse effect observed, Tetradecane,629-59-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48c11e6f-fa84-4db8-a825-e276dd146391/documents/a291b4ed-b665-4c88-8666-a3862be46a0d_dd0c5752-1525-4234-89e2-3e31131805d9.html,,inhalation,LC50,"6,100 mg/m3",no adverse effect observed, Tetradec-1-ene,1120-36-1," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c1caba0-27cb-4ac4-a324-eae1e8d738b4/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_8ea3dc1e-b1a4-40d3-b71c-45142eab7bd3.html,,,,,, Tetradec-1-ene,1120-36-1,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c1caba0-27cb-4ac4-a324-eae1e8d738b4/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_8ea3dc1e-b1a4-40d3-b71c-45142eab7bd3.html,,,,,, 2-tetradecyloctadecan-1-ol,32582-32-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/548873f6-7c1f-4669-8c1d-b1b113883228/documents/IUC5-29c16d25-5b3e-41e0-9b5a-db28425d4c28_b171a1f1-6bfa-48d7-8a35-3028d3bcb751.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,839.6 mg/kg bw/day,, 2-tetradecyloctadecan-1-ol,32582-32-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/548873f6-7c1f-4669-8c1d-b1b113883228/documents/IUC5-cd44c198-ab73-455a-980b-1f98163a14d5_b171a1f1-6bfa-48d7-8a35-3028d3bcb751.html,,oral,discriminating dose,"39,069 mg/kg bw",no adverse effect observed, 2-tetradecyloctadecan-1-ol,32582-32-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/548873f6-7c1f-4669-8c1d-b1b113883228/documents/IUC5-cd44c198-ab73-455a-980b-1f98163a14d5_b171a1f1-6bfa-48d7-8a35-3028d3bcb751.html,,dermal,discriminating dose,"1,790 mg/kg bw",no adverse effect observed, Tetraethyl orthosilicate,78-10-4,"The key repeated dose toxicity data set for tetraethyl orthosilicate (CAS No. 78-10-4, EC No. 201-083-8) is comprised of the key oral study for its condensed hydrolysis product polysilicic acid (equivalent to synthetic amorphous silica [SAS], CAS No. 112926-00-8, EC No. 231-545-4) and the key inhalation study for tetraethyl orthosilicate.   In the key repeated dose oral toxicity study conducted according to OECD Test Guideline 408 and in compliance with GLP (Kim et al. 2014, reliability score 1), the systemic NOAELs for two particle sizes of SAS (20 and 100 nm) in the Sprague-Dawley rat were concluded to be ≥2000 mg/kg bw/day.   In the key repeated inhalation study conducted in a manner similar to OECD 412 (no information on GLP status, Omae et al. 1995, reliability score 2), the LOAEC for tetraethyl orthosilicate was 50 ppm vapour (approximately 0.4 mg/L) in male mice after a 2- or 4-week exposure, based primarily on histopathological (inflammatory) findings in the nasal mucosa and with some haematological changes noted. Renal histopathology was observed at 100 ppm (approximately 0.9 mg/L). A NOAEC was not identified. As discussed in the endpoint summary, the renal and nasal cavity findings are considered related to a physical effect of the condensed hydrolysis product polysilicic acid, and not to tetraethyl orthosilicate toxicity.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c16b669-d39a-4294-981a-7a860ef1b80c/documents/87fc49e6-7d05-4d08-955f-6fdac3f7e709_6c88af6c-d581-4200-bc49-ff4851e0295f.html,,,,,, Tetraethyl orthosilicate,78-10-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c16b669-d39a-4294-981a-7a860ef1b80c/documents/87fc49e6-7d05-4d08-955f-6fdac3f7e709_6c88af6c-d581-4200-bc49-ff4851e0295f.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,426 mg/m3,,mouse Tetraethyl orthosilicate,78-10-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c16b669-d39a-4294-981a-7a860ef1b80c/documents/87fc49e6-7d05-4d08-955f-6fdac3f7e709_6c88af6c-d581-4200-bc49-ff4851e0295f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,000 mg/kg bw/day",,rat Tetraethyl orthosilicate,78-10-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c16b669-d39a-4294-981a-7a860ef1b80c/documents/87fc49e6-7d05-4d08-955f-6fdac3f7e709_6c88af6c-d581-4200-bc49-ff4851e0295f.html,Repeated dose toxicity – local effects,inhalation,LOAEC,426 mg/m3,adverse effect observed,mouse Tetraethyl orthosilicate,78-10-4,"In the key acute oral study conducted according to OECD Test Guideline 423 and in compliance with GLP (Bayer AG 2001, reliability score 1), the LD50 for tetraethyl orthosilicate (CAS No. 78-10-4, EC No. 201-083-8) in the rat was >2500 mg/kg bw.   In the key acute inhalation study conducted according to OECD Test Guideline 403 and in compliance with GLP (Hoechst AG 1991, reliability score 1), the LC50 for tetraethyl orthosilicate was 10.0 mg/L aerosol in male rats and >16.8 mg/L aerosol in female rats.   For the acute dermal route, there were no reliable data, and thus no key study identified. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score of 1, based on the acute oral toxicity (reliability score 1) data for tetraethyl orthosilicate Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Klimisch score of 1, based on the acute inhalation toxicity (reliability score 1) data for tetraethyl orthosilicate ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c16b669-d39a-4294-981a-7a860ef1b80c/documents/d083931b-2f7e-4f9f-b391-2d1a6dacd732_6c88af6c-d581-4200-bc49-ff4851e0295f.html,,,,,, Tetraethyl orthosilicate,78-10-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c16b669-d39a-4294-981a-7a860ef1b80c/documents/d083931b-2f7e-4f9f-b391-2d1a6dacd732_6c88af6c-d581-4200-bc49-ff4851e0295f.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Tetraethyl orthosilicate,78-10-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c16b669-d39a-4294-981a-7a860ef1b80c/documents/d083931b-2f7e-4f9f-b391-2d1a6dacd732_6c88af6c-d581-4200-bc49-ff4851e0295f.html,,inhalation,LC50,"10,000 mg/m3",adverse effect observed, "(1E)-1,3,3,3-tetrafluoroprop-1-ene",29118-24-9," Several repeated dose toxicity studies are available (2-weeks, 4-weeks and 13-weeks of exposure). No toxicity was observed in male or female rats exposed to concentrations up to 5 000 ppm for 6 hours/day for 2, or 13 weeks, or concentrations up to 10 000 ppm following 4 weeks of exposure.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01d9a2f8-ccf4-4e42-ba29-8f8541c77325/documents/f07416a4-d70d-4fd0-8a95-343188a15eab_2b623282-7e17-436b-96ec-57c3b1324358.html,,,,,, "(1E)-1,3,3,3-tetrafluoroprop-1-ene",29118-24-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01d9a2f8-ccf4-4e42-ba29-8f8541c77325/documents/f07416a4-d70d-4fd0-8a95-343188a15eab_2b623282-7e17-436b-96ec-57c3b1324358.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"23,300 mg/m3",,rat "(1E)-1,3,3,3-tetrafluoroprop-1-ene",29118-24-9,"No mortality at inhalation exposure concentrations as high as 207000 ppm (964620 mg/m3) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): GLP compliant OECD TG 403 study ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01d9a2f8-ccf4-4e42-ba29-8f8541c77325/documents/0e408780-10a8-4607-a858-8caa5b6a34cd_2b623282-7e17-436b-96ec-57c3b1324358.html,,,,,, "(1E)-1,3,3,3-tetrafluoroprop-1-ene",29118-24-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01d9a2f8-ccf4-4e42-ba29-8f8541c77325/documents/0e408780-10a8-4607-a858-8caa5b6a34cd_2b623282-7e17-436b-96ec-57c3b1324358.html,,inhalation,discriminating conc.,"> 207,000 ",no adverse effect observed, Tetrahydro-2-isobutyl-4-methyl-2H-pyran,13477-62-8," In a combined repeated dose toxicity and reproduction/developmental toxicity screening study according to OECD TG 422 and GLP, tetrahydro-2-isobutyl-4-methyl-2H-pyran was administered daily to groups of 10 male and 10 female Wistar rats by gavage at doses of 50, 150 and 500 mg/kg bw/d in corn oil (BASF 2018; 85R0080/13R165). The NOAEL for general systemic toxicity was 500 mg/kg bw/d tetrahydro-2-isobutyl-4-methyl-2H-pyran, i.e. the highest dose tested. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d650f5e5-f61d-4912-a279-9191dc1c3e5b/documents/IUC5-7ec7ac9d-b324-43ba-97f0-39ad9d15a328_7e49abca-40e1-4346-8636-0ac7eb11bde3.html,,,,,, Tetrahydro-2-isobutyl-4-methyl-2H-pyran,13477-62-8,Acute oral toxicity (similar to OECD 401): LD50>5000 mg/kg bw (BASF 1983; 83/186)Acute inhalation toxicity (IHT): No mortality after 7h exposure of a vapor saturated atmosphere (BASF1993;10I0358/927012). Acute dermal toxicity (similar to OECD 402): LD50>2000 mg/kg bw (BASF 1984; 83/186) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d650f5e5-f61d-4912-a279-9191dc1c3e5b/documents/IUC5-1edd6843-58d6-4701-9133-5d033ab9f7e8_7e49abca-40e1-4346-8636-0ac7eb11bde3.html,,,,,, Tetrahydro-6-(3-pentenyl)-2H-pyran-2-one,32764-98-0,"Oral: LD50= > 5000 mg/kg bw, male rat, equiv. to OECD 401, Moreno 1980Dermal: LD50= > 2000 mg/kg bw, male/female rabbit, equiv. to OECD 402, Moreno 1979 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9bf9515-0306-4606-9826-e1affd0d434d/documents/IUC5-8a41f2ff-f687-40d2-901a-97a892d47abc_ee6c6ffc-8676-4c84-9435-248053059a85.html,,,,,, Tetrahydro-6-(3-pentenyl)-2H-pyran-2-one,32764-98-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9bf9515-0306-4606-9826-e1affd0d434d/documents/IUC5-8a41f2ff-f687-40d2-901a-97a892d47abc_ee6c6ffc-8676-4c84-9435-248053059a85.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Tetrahydro-6-(3-pentenyl)-2H-pyran-2-one,32764-98-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9bf9515-0306-4606-9826-e1affd0d434d/documents/IUC5-8a41f2ff-f687-40d2-901a-97a892d47abc_ee6c6ffc-8676-4c84-9435-248053059a85.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4-methylpyran-4-ol,63500-71-0,"Repeated dose toxicity - NOAEL (male/female) = 125 mg/kg bw/d (gavage, OECD 407, GLP)NOAEL (male/female) = 1000 mg/kg bw/d (dermal, OECD 411, GLP) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f220953-2d06-4e9f-a4ed-a957142552d0/documents/IUC5-fbde1016-07cb-489a-b270-ccf142e43672_fb287dae-ca2d-4585-9e3a-4655b785257e.html,,,,,, A mixture of: cis-tetrahydro-2-isobutyl-4-methylpyran-4-ol; trans-tetrahydro-2-isobutyl-4-methylpyran-4-ol,63500-71-0,The LD50 value derived from the acute oral toxicity study with Tetrahydro-4-methyl-2-(2-methylpropyl) -2H-pyran-4-ol is > 2000 mg/kg bw. The dermal LD50 is > 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f220953-2d06-4e9f-a4ed-a957142552d0/documents/IUC5-e1b2ab23-ddc8-45ba-be79-53b2ce83f9f5_fb287dae-ca2d-4585-9e3a-4655b785257e.html,,,,,, Tetrahydro-4-methyl-2-phenyl-2H-pyran,94201-73-7,"oral: LD50 >2000mg/kg bw, male and female rat, EU Method B.1, Toxicol Laboratories Limited 1992 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95142358-3749-47c7-a4fb-c02449fb43b1/documents/IUC5-e2cd7ece-c7ff-4d90-a336-e8b99c3f7a59_2f044ce9-f08c-4794-89ec-ff7857ce38db.html,,,,,, Tetrahydro-4-methyl-2-phenyl-2H-pyran,94201-73-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95142358-3749-47c7-a4fb-c02449fb43b1/documents/IUC5-e2cd7ece-c7ff-4d90-a336-e8b99c3f7a59_2f044ce9-f08c-4794-89ec-ff7857ce38db.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran,131766-73-9,The LD50 in the standard acute toxicity test on rats is 4500 mg/kg bw. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27b6ca7e-77f5-496d-93ba-732a60292f8b/documents/7f83ce5c-ff68-4363-9205-83843ddab825_4568c503-4811-41d5-a7c9-d917dae628e5.html,,,,,, A mixture of: trans-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran; cis-4-acetoxy-4-methyl-2-propyl-tetrahydro-2H-pyran,131766-73-9,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27b6ca7e-77f5-496d-93ba-732a60292f8b/documents/7f83ce5c-ff68-4363-9205-83843ddab825_4568c503-4811-41d5-a7c9-d917dae628e5.html,,oral,LD50,"4,500 mg/kg bw",, Tetrahydrofurfuryl methacrylate,2455-24-5,"Subacute study; oral (gavage); rat (Sprague Dawley), m/f (OECD guideline 422, GLP): NOAEL = 300 mg/kg bw/d ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/594c6898-e8c7-4604-a360-d9cf2a2cae3e/documents/IUC5-08e3eee9-b4ec-40c0-a94d-3156e921a2c3_166e7010-e9ad-4277-8f91-13eda9271261.html,,,,,, Tetrahydrofurfuryl methacrylate,2455-24-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/594c6898-e8c7-4604-a360-d9cf2a2cae3e/documents/IUC5-08e3eee9-b4ec-40c0-a94d-3156e921a2c3_166e7010-e9ad-4277-8f91-13eda9271261.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Tetrahydrofurfuryl methacrylate,2455-24-5,"Acute oral toxicity: LD50 (rat, males/females) = 3945 mg/kg bw; OECD Guideline 401; pre-GLP studyAcute dermal toxicity: not necessary due to scientific considerationsAcute inhalation toxicity: not necessary due to exposure considerations ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/594c6898-e8c7-4604-a360-d9cf2a2cae3e/documents/IUC5-5c144ff7-acf1-469a-8dee-15519d26a099_166e7010-e9ad-4277-8f91-13eda9271261.html,,,,,, Tetrahydrofurfuryl methacrylate,2455-24-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/594c6898-e8c7-4604-a360-d9cf2a2cae3e/documents/IUC5-5c144ff7-acf1-469a-8dee-15519d26a099_166e7010-e9ad-4277-8f91-13eda9271261.html,,oral,LD50,"3,945 mg/kg bw",no adverse effect observed, "4,4a,5,9b-tetrahydroindeno[1,2-d]-1,3-dioxin",18096-62-3," Females: Oral (OECD 422), rat: NOAEL systemic: 20 mg/kg bw/day, based on liver hepatocyte necrosis Oral (OECD 422), rat: LOAEL neurobehavioral parameter: 1 mg/kg bw/day, based on decreased spontaneous motor activity Males: Oral (OECD 422), rat: LOAEL systemic: 20 mg/kg bw/day for male rat-specific alpha-2 -microglobulin-associated nephropathy; excluding this effect NOAEL was 100 mg/kg bw/day Oral (OECD 422), rat: LOAEL neurobehavioral parameter: ≥ 20 mg/kg bw/day (based on no effect at highest dose tested) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57aa8817-20a5-413e-9f34-68a5f0f86b03/documents/47327434-4126-4a20-857e-e7a35d4a809c_50bda73c-906f-4f00-9fc6-baf40712b6e2.html,,,,,, "4,4a,5,9b-tetrahydroindeno[1,2-d]-1,3-dioxin",18096-62-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57aa8817-20a5-413e-9f34-68a5f0f86b03/documents/47327434-4126-4a20-857e-e7a35d4a809c_50bda73c-906f-4f00-9fc6-baf40712b6e2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "4,4a,5,9b-tetrahydroindeno[1,2-d]-1,3-dioxin",18096-62-3," Oral (OECD 401), rat: LD50 > 2000 mg/kg bw (limit test) Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57aa8817-20a5-413e-9f34-68a5f0f86b03/documents/69e310eb-16f2-43ef-95e1-c40bea1eecc7_50bda73c-906f-4f00-9fc6-baf40712b6e2.html,,,,,, "4,4a,5,9b-tetrahydroindeno[1,2-d]-1,3-dioxin",18096-62-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57aa8817-20a5-413e-9f34-68a5f0f86b03/documents/69e310eb-16f2-43ef-95e1-c40bea1eecc7_50bda73c-906f-4f00-9fc6-baf40712b6e2.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,6-dimethyloctan-2-ol",18479-57-7," The Repeated dose toxicity of Tetrahydromyrcenol is derived from Dihydromyrcenol which was tested in an OECD TG 422. A NOAEL = >868.7 mg/kg/day was derived, resulting in 'no adverse effects'. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3e2ec4b-8dd4-4bd2-9495-0b6fb16b87c7/documents/30347479-133b-49b2-b973-43c4c689e7f6_e615a2e9-7756-48bb-a16b-28214ecb98be.html,,,,,, "2,6-dimethyloctan-2-ol",18479-57-7, Acute oral toxicity (OECDTG401): >5000 mg/kg bw Acute dermal toxicity (OECDTG402): >5000 mg/kg bw Acute inhalation toxicity using route to route extrapolation from the oral route: > 13000 mg/m3 ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3e2ec4b-8dd4-4bd2-9495-0b6fb16b87c7/documents/db33cd19-5624-4ca3-bca6-3762092fa114_e615a2e9-7756-48bb-a16b-28214ecb98be.html,,,,,, "3,7-dimethyloctan-3-ol",78-69-3,"Repeated dose toxicity - oral: 90 d, rat, feeding: NOAEL = 5000 ppm; 316/384 mg/kg bw/day in males/females (according to OECD 408, GLP; BASF 2019; 50C0267/10C194)Repeated dose toxicity - dermal: 90 d, rat, open: NOAEL = 250 mg/kg bw/d (similar to OECD 411, GLP T&O 79-201, Read-Across to CAS No. 78-70-6) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00acfeb4-5dc5-47f1-b4b6-e218398a5423/documents/IUC5-878e7429-808a-4fff-a1ac-89e95c620461_b3c1693d-24e1-4aca-ab4a-32fd57bbafbf.html,,,,,, "3,7-dimethyloctan-3-ol",78-69-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00acfeb4-5dc5-47f1-b4b6-e218398a5423/documents/IUC5-878e7429-808a-4fff-a1ac-89e95c620461_b3c1693d-24e1-4aca-ab4a-32fd57bbafbf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,316 mg/kg bw/day,,rat "3,7-dimethyloctan-3-ol",78-69-3,Oral - rat LD50 = 8270 mg/kg bw (BASF AG 1980)Dermal - rat LD50 > 5000 mg/kg bw (Moreno 1976)Inhalation - Rat: IHT: 8h: no mortality in a saturated vapour atmosphere (BASF 1980)Dermal - Rabbit: LD 50 > 5000 mg/kg bw (Moreno 1976) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00acfeb4-5dc5-47f1-b4b6-e218398a5423/documents/IUC5-0cb76379-1755-410b-bddf-41a67295895c_b3c1693d-24e1-4aca-ab4a-32fd57bbafbf.html,,,,,, "3,7-dimethyloctan-3-yl acetate",20780-48-7, Repeated dose toxicity - oral (OECD TG 422): NOAEL >= 500 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/787bb5c5-09fe-435d-b68d-f0a3f99c98ae/documents/cfa4d536-7dad-48af-9d89-1d08804fa89a_ed5a4f24-b7cb-4f5e-9dce-5e23c6664dbd.html,,,,,, "3,7-dimethyloctan-3-yl acetate",20780-48-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/787bb5c5-09fe-435d-b68d-f0a3f99c98ae/documents/cfa4d536-7dad-48af-9d89-1d08804fa89a_ed5a4f24-b7cb-4f5e-9dce-5e23c6664dbd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "3,7-dimethyloctan-3-yl acetate",20780-48-7," Acute oral toxicity (similar to OECD TG 401): LD50 > 2000 mg/kg bw Acute inhalation toxicity (WoE, non-guideline studies): LC50 > 3.2 mg/L (no mortality) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/787bb5c5-09fe-435d-b68d-f0a3f99c98ae/documents/bf4fd4f4-3a0e-4e8d-ac55-aa8184a750f5_ed5a4f24-b7cb-4f5e-9dce-5e23c6664dbd.html,,,,,, "1,1',1'',1'''-ethylenedinitrilotetrapropan-2-ol",102-60-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4ac7f33-0f62-4d2d-ab64-6419ba497423/documents/IUC5-6e933a79-b57a-40df-8ec0-79fb11a94150_25d10d23-9e9b-461d-863c-e6cee7d3eae5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2,4,7,9-tetramethyldec-5-yne-4,7-diol",126-86-3,"Under the conditions of a 28 d oral toxicity study according to OECD guideline 422, higher mean liver weights in combination with changes in clinical chemistry parameters and hepatocellular hypertrophy were noted at 7500 ppm in both sexes. Therefore, a dietary concentration of 2500 ppm was considered to be the no-observed-adverse-effect level (NOAEL) for F0 systemic toxicity of the test item when administered continuously in the diet to Crl:CD(SD) rats. This concentration corresponded to mean dose levels of 174 and 208 mg/kg/day for F0 males and females during the premating period, respectively, Gestation Days 0–20, Lactation Days 1–4, and Lactation Days 4-13, respectively. Additionally, 2,4,7,9-Tetramethyl-5-decyne-4,7-diol, when fed to rats under the conditions of an one generation reproductive toxicity study, showed no effect at 500 mg/kg/day (NOEL).At 2,000 mg/kg/day slightly decreased mean body weigths of females after weaning, lacation indices in combination with slghtliy reduced food consumption were observed. At dose levels at greater than or equal to 1,000 mg/kg/day slightly decreased body weight gain, increased liver weight and swelling of hepatocytes were observed in the F1a generation (epxosure duration: 91 days).There were no other significant changes in any parameter reported. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Reliable without restriction (guideline study) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37960285-88c7-4d2c-ba07-feb64dd23a54/documents/bcabcdad-d51f-4a67-9158-983d142d403f_f57540ac-c060-418a-b536-1e52633aa8eb.html,,,,,, "2,4,7,9-tetramethyldec-5-yne-4,7-diol",126-86-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37960285-88c7-4d2c-ba07-feb64dd23a54/documents/bcabcdad-d51f-4a67-9158-983d142d403f_f57540ac-c060-418a-b536-1e52633aa8eb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,174 mg/kg bw/day,,rat "2,4,7,9-tetramethyldec-5-yne-4,7-diol",126-86-3,"According to the UN Globally Harmonized System of ClassificThe subject material when studied in male albino raation and Labelling of Chemicals (GHS) Part 3 Chapter 3.1 no classification required, Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable with restriction Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Study has been done before the establishment of GLP, but is following the Guide to Precautionary Labeling of Hazardous Chemicals, Seventh Edition - 1970, published by the Manufacturing Chemist´s Association. Klimisch score 2. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The key study is GLP compliant and is of high quality, Klimisch score = 1 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37960285-88c7-4d2c-ba07-feb64dd23a54/documents/b183d029-ea3c-475b-aefe-a4571b3afd4e_f57540ac-c060-418a-b536-1e52633aa8eb.html,,,,,, "2,4,7,9-tetramethyldec-5-yne-4,7-diol",126-86-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37960285-88c7-4d2c-ba07-feb64dd23a54/documents/b183d029-ea3c-475b-aefe-a4571b3afd4e_f57540ac-c060-418a-b536-1e52633aa8eb.html,,oral,LD50,"12,900 mg/kg bw",no adverse effect observed, "2,4,7,9-tetramethyldec-5-yne-4,7-diol",126-86-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37960285-88c7-4d2c-ba07-feb64dd23a54/documents/b183d029-ea3c-475b-aefe-a4571b3afd4e_f57540ac-c060-418a-b536-1e52633aa8eb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,4,7,9-tetramethyldec-5-yne-4,7-diol",126-86-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37960285-88c7-4d2c-ba07-feb64dd23a54/documents/b183d029-ea3c-475b-aefe-a4571b3afd4e_f57540ac-c060-418a-b536-1e52633aa8eb.html,,inhalation,LC50,"1,000 mg/m3",no adverse effect observed, "1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane",3982-82-9," The key acute oral toxicity study, conducted according to OECD TG 423, and in compliance with GLP, reports an LD50 value of >2000 mg/kg bw for 1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane (LPT, 2002). The key acute dermal toxicity study, conducted according to OECD TG 402, and in compliance with GLP, reports an LD50 value of >2000 mg/kg bw for 1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane (DCC, 2000). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a4d7c6c-1d2f-4b62-acf0-f7ad7d30dcca/documents/ea7ec1e6-616c-460c-b6d6-d6f99bab1493_36a2f690-ef7f-47a1-b871-7ca621023e8a.html,,,,,, "1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane",3982-82-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a4d7c6c-1d2f-4b62-acf0-f7ad7d30dcca/documents/ea7ec1e6-616c-460c-b6d6-d6f99bab1493_36a2f690-ef7f-47a1-b871-7ca621023e8a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3,3,5-tetramethyl-1,1,5,5-tetraphenyltrisiloxane",3982-82-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a4d7c6c-1d2f-4b62-acf0-f7ad7d30dcca/documents/ea7ec1e6-616c-460c-b6d6-d6f99bab1493_36a2f690-ef7f-47a1-b871-7ca621023e8a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "β,2,2,3-tetramethylcyclopent-3-ene-1-butanol",72089-08-8," Oral (OECD 401), rat: LD50 = 5.24 mL/kg bw (corresponding to 4716 mg/kg bw based on a density of 0.9 mg/cm³) Oral (OECD 401), rat: LD50 > 20 mL/kg bw (corresponding to > 18000 mg/kg bw based on a density of 0.9 mg/cm³) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d6c74b4-f52a-40fe-853d-28b2fdb896e4/documents/52aaac44-2cfe-4dfa-a192-126da96360a2_e4f718fe-7e19-4b1b-99ce-be2c10ee19a3.html,,,,,, Tetramethylammonium chloride,75-57-0,A 90 -day repeated dose study with tetramethylammonium chloride is available. This study was conducted according to OECD/ EC guidelines and under GLP principles (Klimisch score 1). ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa18248c-c429-453a-a23c-2c009cb41ac8/documents/IUC5-699a543f-d3cc-4913-a034-291020bb486b_b44758fe-2af8-4871-8ffa-c7ece96dce61.html,,,,,, Tetramethylammonium chloride,75-57-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa18248c-c429-453a-a23c-2c009cb41ac8/documents/IUC5-699a543f-d3cc-4913-a034-291020bb486b_b44758fe-2af8-4871-8ffa-c7ece96dce61.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Tetramethylammonium chloride,75-57-0,"Three studies were available on the oral toxicity of TMAC. These studies resulted in the following LD50's:TNO1978: LD50 = 47 mg/kg bw (conducted with 2% TMAC)MB2007: LD50 = 55 mg/kg bw (conducted with 10% TMAC)MB2010: LD50 = 171,9 mg/kg bw (conducted with 15% TMAC)One dermal study is available (MB2007), which resulted in an LD50 of >200 and <500 mg/kg bw. Three studies are available. One study (TNO1978) was performed before test guidelines and GLP principles were in place. There is missing information and shortcomings in description of the methods: no details on test substance (Lot/Batch number; purity) were given (reliability 2). Two reports from MB are available, conducted in 2007 and 2010, both studies have reliability 1 and were performed according to current OECD guidelines under GLP principles.  ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa18248c-c429-453a-a23c-2c009cb41ac8/documents/IUC5-44286d50-9192-4cad-899e-9004a5f13baf_b44758fe-2af8-4871-8ffa-c7ece96dce61.html,,,,,, Tetramethylammonium chloride,75-57-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa18248c-c429-453a-a23c-2c009cb41ac8/documents/IUC5-44286d50-9192-4cad-899e-9004a5f13baf_b44758fe-2af8-4871-8ffa-c7ece96dce61.html,,oral,LD50,47 mg/kg bw,adverse effect observed, Tetramethylammonium chloride,75-57-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa18248c-c429-453a-a23c-2c009cb41ac8/documents/IUC5-44286d50-9192-4cad-899e-9004a5f13baf_b44758fe-2af8-4871-8ffa-c7ece96dce61.html,,dermal,discriminating dose,200 mg/kg bw,adverse effect observed, "α,α,6,6-tetramethylbicyclo[3.1.1]hept-2-ene-2-propionaldehyde",33885-52-8," Repeated dose toxicity (OECD TG 422): NOAEL = 83 mg/kg bw, Target organs were liver and especially kidneys on which the NOAEL is based. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be4f3035-18fc-4486-8fed-5d666655c09c/documents/4e020dab-969b-4d30-9c09-87737dd3384c_419f673c-864f-4255-84a0-584d6edca915.html,,,,,, "α,α,6,6-tetramethylbicyclo[3.1.1]hept-2-ene-2-propionaldehyde",33885-52-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be4f3035-18fc-4486-8fed-5d666655c09c/documents/4e020dab-969b-4d30-9c09-87737dd3384c_419f673c-864f-4255-84a0-584d6edca915.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,83 mg/kg bw/day,,rat "α,α,6,6-tetramethylbicyclo[3.1.1]hept-2-ene-2-propionaldehyde",33885-52-8, Acute oral toxicity using read across from Floralozone (tested in a study similar to OECD TG 401): LD50 > 5000 mg/kg bw Acute dermal toxicity using read across from Floralozone (tested in a study similar to OECD TG 402): LD50 > 5000 mg/kg bw Acute inhalation toxicity using route to route extrapolation from the oral route: > 13000 mg/m3. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be4f3035-18fc-4486-8fed-5d666655c09c/documents/IUC5-18ed2cc6-9dc6-46c7-a620-0b0e5be27600_419f673c-864f-4255-84a0-584d6edca915.html,,,,,, "Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione",5395-50-6,Acute oral toxicity: Key study: OECD Guideline 401. The oral LD50 in rats was determined to be higher than 5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24d7a92f-ba6a-4891-aca0-43d204acbf2b/documents/65bbefef-7e13-484f-a140-b1dd3ae502af_25646954-e1e4-4e65-a1dc-3c3bfcb1e2ce.html,,,,,, "Tetrahydro-1,3,4,6-tetrakis(hydroxymethyl)imidazo[4,5-d]imidazole-2,5(1H,3H)-dione",5395-50-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24d7a92f-ba6a-4891-aca0-43d204acbf2b/documents/65bbefef-7e13-484f-a140-b1dd3ae502af_25646954-e1e4-4e65-a1dc-3c3bfcb1e2ce.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Tetrapotassium pyrophosphate,7320-34-5," One key study (Seo DS, 2011) is available to assess the repeated dose toxicity of tetrapotassium pyrophosphate. This study is considered to be a reliability 2 study as it has been conducted to the current guideline (OECD Method 408) but with minor deviations. This study is conducted on the analogous substance tetrasodium pyrophosphate (see below for read-across justification). It is considered appropriate on the basis of toxicokinetic information with regards to the inorganic nature of the substance to use this data to extrapolate to inhalation and dermal routes and as such no further testing is considered to be justified for this endpoint. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18c3f63b-720d-4cfc-85db-b0149d969dc9/documents/IUC5-a01d7996-ca58-4355-bec0-dc09270b9cbb_a2b4b5aa-0f94-4eb9-8a0c-5bcba3651134.html,,,,,, Tetrapotassium pyrophosphate,7320-34-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18c3f63b-720d-4cfc-85db-b0149d969dc9/documents/IUC5-a01d7996-ca58-4355-bec0-dc09270b9cbb_a2b4b5aa-0f94-4eb9-8a0c-5bcba3651134.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Tetrapotassium pyrophosphate,7320-34-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): LD50 >2,000 mg/kg bw No key study exists for tetrapotassium pyrophosphate. A weight of evidence (reliability 1, 2 and 4 studies) on tetrapotassium pyrophosphate and the analogous substance tetrasodium pyrophosphate is used to meet the endpoint requirements. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): LC50 >1.1 mg/L (highest dose tested) One key study (reliability 2) is available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): LD50 >2,000 mg/kg bw One key study (reliability 1, OECD 402) is available for an analogous substance. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18c3f63b-720d-4cfc-85db-b0149d969dc9/documents/IUC5-2e8ada7d-2024-4496-af46-a89ed98bc5e7_a2b4b5aa-0f94-4eb9-8a0c-5bcba3651134.html,,,,,, Tetrasodium ethylenediaminetetraacetate,64-02-8, oral There are no repeated dose studies with Na4EDTA available. A 90 day study with Na2H2EDTA as well as 2 years feeding studies with Na3EDTA on rats and mice provide reliable toxicological information for an overall NOAEL of about 500 mg/kg bw/day.   inhalative A NOAEC of 3 mg/m³ air was established in a subchronic toxicity study with Na2H2EDTA. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9055fd5-33ad-4e46-bc9e-4afe3d041ebf/documents/IUC5-b5bd5ac4-7ae5-43b8-bda0-052f709cde91_cc9c40b6-2afb-4db1-b1c2-f7fcf5127ffd.html,,,,,, Tetrasodium ethylenediaminetetraacetate,64-02-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9055fd5-33ad-4e46-bc9e-4afe3d041ebf/documents/IUC5-b5bd5ac4-7ae5-43b8-bda0-052f709cde91_cc9c40b6-2afb-4db1-b1c2-f7fcf5127ffd.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Tetrasodium ethylenediaminetetraacetate,64-02-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9055fd5-33ad-4e46-bc9e-4afe3d041ebf/documents/IUC5-b5bd5ac4-7ae5-43b8-bda0-052f709cde91_cc9c40b6-2afb-4db1-b1c2-f7fcf5127ffd.html,Repeated dose toxicity – local effects,inhalation,NOAEC,3 mg/m3,adverse effect observed,rat Tetrasodium ethylenediaminetetraacetate,64-02-8," oral LD50 of Na4EDTA was found to be > 1780 mg/kg bw (BASF 1983) Inhalative  LOAEC value of 30 mg/m³ air was established in a subacute range finder toxicity study with Na2H2EDTA, which here is also suitable to assess acute toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9055fd5-33ad-4e46-bc9e-4afe3d041ebf/documents/IUC5-46e3703c-17a2-4596-8e53-a8b30ea6a0be_cc9c40b6-2afb-4db1-b1c2-f7fcf5127ffd.html,,,,,, Tetrasodium ethylenediaminetetraacetate,64-02-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9055fd5-33ad-4e46-bc9e-4afe3d041ebf/documents/IUC5-46e3703c-17a2-4596-8e53-a8b30ea6a0be_cc9c40b6-2afb-4db1-b1c2-f7fcf5127ffd.html,,oral,LD50,"1,780 mg/kg bw",adverse effect observed, Tetrasodium ethylenediaminetetraacetate,64-02-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9055fd5-33ad-4e46-bc9e-4afe3d041ebf/documents/IUC5-46e3703c-17a2-4596-8e53-a8b30ea6a0be_cc9c40b6-2afb-4db1-b1c2-f7fcf5127ffd.html,,inhalation,,30 mg/m3,adverse effect observed, Tetrasodium (1-hydroxyethylidene)bisphosphonate,3794-83-0,"There are no repeated dose toxicity data for HEDP-4Na, therefore good quality data are read-across from the category member HEDP (2 -3Na).   In a well conducted, repeated oral dose toxicity study (reliability score 2), conducted using a protocol according to OECD 408 (Repeated Dose 90-Day Oral Toxicity in Rodents) and pre-GLP, the NOAEL for HEDP (2 -3Na) was concluded to be 41 mg/kg bw/day (equivalent to 34 mg active acid/kg bw/day) based on anaemia at high doses (Huntingdon, 1977).   No repeated dose inhalation or dermal studies are available.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20d8870b-0dfa-4778-ada0-0a6041608bcb/documents/ed8d6f4a-edbd-4e5e-ad81-91aec1f5f020_15c068d4-d8a8-4d2d-a413-54fda05b4880.html,,,,,, Tetrasodium (1-hydroxyethylidene)bisphosphonate,3794-83-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20d8870b-0dfa-4778-ada0-0a6041608bcb/documents/ed8d6f4a-edbd-4e5e-ad81-91aec1f5f020_15c068d4-d8a8-4d2d-a413-54fda05b4880.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,34 mg/kg bw/day,,rat Tetrasodium (1-hydroxyethylidene)bisphosphonate,3794-83-0,"In an acute oral study conducted using a protocol similar to the now deleted OECD Test Guideline 401 but pre-GLP, undiluted HEDP-4Na was administered to five Sprague-Dawley rats by oral gavage at doses of 2000, 2500, 3200 or 4000 mg/kg bw (33% aqueous solution). The LD50 was calculated to be 2850 mg/kg bw (equivalent to 940 mg/kg/day bw active salt based on a 33% solution, and 659 mg/kg bw/day active acid) (BioDynamics Inc., 1985; reliability 2).   In a well-conducted acute dermal toxicity limit test conducted according to a protocol similar to OECD Test Guideline 402 and pre-GLP, 5000 mg/kg bw of HEDP-4Na (31% aqueous solution) was applied to the skin of New Zealand white rabbits (5 per sex) under an occlusive dressing for 24 hours. The LD50 was determined to be >5000 mg/kg bw (equivalent to >1550 mg active salt/kg bw and >1087 mg parent acid in aqueous solution) (BioDynamics Inc., 1985; reliability 2).   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20d8870b-0dfa-4778-ada0-0a6041608bcb/documents/8eb63d67-1dad-4eca-82cc-12bd41ac67fe_15c068d4-d8a8-4d2d-a413-54fda05b4880.html,,,,,, Tetrasodium (1-hydroxyethylidene)bisphosphonate,3794-83-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20d8870b-0dfa-4778-ada0-0a6041608bcb/documents/8eb63d67-1dad-4eca-82cc-12bd41ac67fe_15c068d4-d8a8-4d2d-a413-54fda05b4880.html,,oral,LD50,> 940 mg/kg bw,no adverse effect observed, Tetrasodium (1-hydroxyethylidene)bisphosphonate,3794-83-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20d8870b-0dfa-4778-ada0-0a6041608bcb/documents/8eb63d67-1dad-4eca-82cc-12bd41ac67fe_15c068d4-d8a8-4d2d-a413-54fda05b4880.html,,dermal,LD50,"> 1,550 mg/kg bw",no adverse effect observed, "Tetrasodium N,N-bis(carboxylatomethyl)-L-glutamate",51981-21-6,The No Observed Adverse Effect Level (NOAEL) for GLDA-Na4 in a 90-day oral gavage study in rats was established to be 300 mg/kg bw/day.   ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9f24951-c61a-4991-9887-05f681cae3cf/documents/IUC5-f196a45d-3190-44f7-8c09-ed8656f967fa_eaf97526-acd3-4008-85d3-6dd0b33bc1f1.html,,,,,, "Tetrasodium N,N-bis(carboxylatomethyl)-L-glutamate",51981-21-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9f24951-c61a-4991-9887-05f681cae3cf/documents/IUC5-f196a45d-3190-44f7-8c09-ed8656f967fa_eaf97526-acd3-4008-85d3-6dd0b33bc1f1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Tetrasodium N,N-bis(carboxylatomethyl)-L-glutamate",51981-21-6,"GLDA-Na4 is considered not to have significant acute oral, dermal and respiratory toxicity (see further at Discussion). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9f24951-c61a-4991-9887-05f681cae3cf/documents/IUC5-60b1de9c-a78b-41f1-925a-519448a17f7c_eaf97526-acd3-4008-85d3-6dd0b33bc1f1.html,,,,,, Tetrasodium pyrophosphate,7722-88-5," One key study is available (Seo D, 2011) for the sub-chronic toxicity endpoint. This study is considered to be a reliability 2 study as it has been conducted to the appropriate guideline (OECD 408) and under the conditions of GLP. On the basis of this study the NOAEL was determined to be 500 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b7345ea-d627-4be6-9c23-56ff34ea7c2d/documents/IUC5-ea802f2e-d6e2-4812-a899-85d493b0a334_c6b66254-1cac-4852-9f5b-cf9690228601.html,,,,,, Tetrasodium pyrophosphate,7722-88-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b7345ea-d627-4be6-9c23-56ff34ea7c2d/documents/IUC5-ea802f2e-d6e2-4812-a899-85d493b0a334_c6b66254-1cac-4852-9f5b-cf9690228601.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Tetrasodium pyrophosphate,7722-88-5,"Tetrasodium pyrophosphate has an oral LD50 of ca. 1624 mg/kg bw when tested in accordance with an appropriate method and under the conditions of GLP. Tetrasodium pyrophosphate has an estimated inhalation LC50 of > 01.1 mg/L based on the results of studies performed on analogous substances.Tetrasodium pyrophosphate has a dermal LD50 of > 2,000 mg/kg bw when tested in accordance with an appropriate method and under the conditions of GLP. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b7345ea-d627-4be6-9c23-56ff34ea7c2d/documents/IUC5-fa790ae6-69a7-4a46-bd21-b5d2e28b332b_c6b66254-1cac-4852-9f5b-cf9690228601.html,,,,,, Tetrasodium pyrophosphate,7722-88-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b7345ea-d627-4be6-9c23-56ff34ea7c2d/documents/IUC5-fa790ae6-69a7-4a46-bd21-b5d2e28b332b_c6b66254-1cac-4852-9f5b-cf9690228601.html,,oral,LD50,"1,624 mg/kg bw",adverse effect observed, Theobromine,83-67-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The key study has a Klimish 2 and its results are supported by a pair-fed study. There are other studies performed in other animal species which differ from the OECD guidelines in number of animals per dose group or time exposure but they are scientifically consistent with the key study, and can be taken into account in a weight of evidence. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04aa4186-249b-485a-85b6-328d5360fff7/documents/IUC5-d3060450-48d2-456c-b35a-5201a37e2e28_9fd44be6-1376-46bb-817c-1829e95a0332.html,,,,,, Theobromine,83-67-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04aa4186-249b-485a-85b6-328d5360fff7/documents/IUC5-d3060450-48d2-456c-b35a-5201a37e2e28_9fd44be6-1376-46bb-817c-1829e95a0332.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,349 mg/kg bw/day,,rat Theobromine,83-67-0,Weight of evidence: The oral LD50 for thebromine was determined to be between 837 mg/kg and 1265 mb/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04aa4186-249b-485a-85b6-328d5360fff7/documents/IUC5-766b7e4d-ef68-4865-925c-449245184432_9fd44be6-1376-46bb-817c-1829e95a0332.html,,,,,, Theobromine,83-67-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04aa4186-249b-485a-85b6-328d5360fff7/documents/IUC5-766b7e4d-ef68-4865-925c-449245184432_9fd44be6-1376-46bb-817c-1829e95a0332.html,,oral,LD50,837 mg/kg bw,adverse effect observed, Theophylline,58-55-9,"Theophylline was given to rats and mice by feed or by gavage. In rats theophylline caused nephropathy in all fed male rats and a dose-dependent periarteritis in all treated groups.Oral: subchronic(1) LOAEL rat, female/male, feed, 90 days: 75 mg/kg bw/d [nephropathy (males); periarteritis (females)]; (Collins et al., 1988/NTP 1998) (2) LOAEL rat, female/male gavage, 90 days: 37.5 mg/kg bw/d (periarteritis); (Collins et al., 1988/NTP 1998)(3) LOAEL mouse, male, feed, 90 days: 175 mg/kg bw/d; (reduced body weight); (Collins et al., 1988/NTP 1998) LOAEL mouse, female, feed, 90 days: 225 mg/kg bw/d; (reduced body weight); (Collins et al., 1988/NTP 1998)(4) NOAEL mouse, male, gavage, 90 days: 75 mg/kg bw/d; (reduced body weight); (Collins et al., 1988/NTP 1998) NOAEL mouse, female, gavage, 90 days: 150 mg/kg bw/d; (mortality); (Collins et al., 1988/NTP 1998) chronicLOAEL rat, female/male, gavage, 2 yrs: 7.5 mg/kg bw/d; (reduced body weight); (Nyska et al., 1998/NTP 1998)NOAEL mouse, female, gavage, 2 yrs: 7.5 mg/kg bw/day; (reduced body weight); (NTP 1998)NOAEL mouse, male, gavage, 2 yrs: 50 mg/kg bw/day; (reduced body weight, mortality); (NTP 1998) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/300c7a10-bf27-4139-b232-73180752088d/documents/IUC5-cd9b8a47-2210-451f-b586-83cc947fb788_7fe73b3c-b03a-4db8-9b44-12271c9670d7.html,,,,,, Theophylline,58-55-9,"Oral: LD50 = 272 mg/kg bw, (rat, comparable to OECD 401; BASF AG 1983). Inhalation: LC50 > 6.7 mg/L dust (rat, 4 hours, according to OECD 403; BASF AG 1989). Dermal: LD50 > 2000 mg/kg bw (rat, comparable to OECD 402; BASF AG 1988).The test compound is of moderate toxicity after single ingestion and of low toxicity after inhalation and a single skin contact. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/300c7a10-bf27-4139-b232-73180752088d/documents/IUC5-88f3545e-6db2-46b4-a1ab-01dc3a871674_7fe73b3c-b03a-4db8-9b44-12271c9670d7.html,,,,,, Thiamine hydrochloride,67-03-8," Oral, Peter (2018) Under the conditions of this study, the NOAEL was at least 1000 mg/kg. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d15e22d2-b076-4a5b-8356-45626b9842a3/documents/8f604df9-b15e-4191-90c2-4e56023517e6_5040c337-40d6-45b4-9e39-31cebad34c39.html,,,,,, Thiamine hydrochloride,67-03-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d15e22d2-b076-4a5b-8356-45626b9842a3/documents/8f604df9-b15e-4191-90c2-4e56023517e6_5040c337-40d6-45b4-9e39-31cebad34c39.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Thiamine hydrochloride,67-03-8, Bächtold (1970): Under the conditions of this study the acute oral LD50 of the test material in mice was 13347 ± 1820 mg/kg bw. Bächtold (1976): Under the conditions of this study the acute oral LD50 of the test material in rats was 12340 ± 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d15e22d2-b076-4a5b-8356-45626b9842a3/documents/8de48eb9-c2bb-4d9d-bb8d-18fbda79557f_5040c337-40d6-45b4-9e39-31cebad34c39.html,,,,,, Thiamine hydrochloride,67-03-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d15e22d2-b076-4a5b-8356-45626b9842a3/documents/8de48eb9-c2bb-4d9d-bb8d-18fbda79557f_5040c337-40d6-45b4-9e39-31cebad34c39.html,,oral,LD50,"12,340 mg/kg bw",adverse effect observed, 5-(dithiolan-3-yl)valeric acid,1077-28-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20a0c395-32a1-4f1a-8e6c-3b310d9efc92/documents/99ded749-74d5-4d2e-a890-0f7857b84171_55047f51-f901-4600-ad6b-5803fab9dd3d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,14.7 mg/kg bw/day,,dog 5-(dithiolan-3-yl)valeric acid,1077-28-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Result is based on a OECD study rated Klimisch 1. Therefore the quality is considered good. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20a0c395-32a1-4f1a-8e6c-3b310d9efc92/documents/a45cd08d-8724-4068-97c5-33ae24422ddb_55047f51-f901-4600-ad6b-5803fab9dd3d.html,,,,,, 5-(dithiolan-3-yl)valeric acid,1077-28-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20a0c395-32a1-4f1a-8e6c-3b310d9efc92/documents/a45cd08d-8724-4068-97c5-33ae24422ddb_55047f51-f901-4600-ad6b-5803fab9dd3d.html,,oral,LD50,"1,200 mg/kg bw",adverse effect observed, Thiodiglycol,111-48-8,"A documentation and evaluation of available data on this endpoint is presented in:Thiodiglycol, SIDS Initial Assessment Report for SIAM 19, final version 10/2006. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/786a7bc8-09fe-4393-ab5f-1c3513d4c485/documents/IUC5-a7519406-7ee0-4819-9cd7-18718016f3f5_b338fbbe-0b68-4635-b64c-14f8ce9c29fa.html,,,,,, Thiodiglycol,111-48-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/786a7bc8-09fe-4393-ab5f-1c3513d4c485/documents/IUC5-a7519406-7ee0-4819-9cd7-18718016f3f5_b338fbbe-0b68-4635-b64c-14f8ce9c29fa.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,, Thiodiglycol,111-48-8,"A documentation and evaluation of available data on this endpoint is presented in:Thiodiglycol, SIDS Initial Assessment Report for SIAM 19, final version 10/2006. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/786a7bc8-09fe-4393-ab5f-1c3513d4c485/documents/IUC5-c6ccf7c0-c552-479e-9287-5bb20e960c78_b338fbbe-0b68-4635-b64c-14f8ce9c29fa.html,,,,,, Thiodiglycol,111-48-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/786a7bc8-09fe-4393-ab5f-1c3513d4c485/documents/IUC5-c6ccf7c0-c552-479e-9287-5bb20e960c78_b338fbbe-0b68-4635-b64c-14f8ce9c29fa.html,,oral,LD50,"11,800 mg/kg bw",, "3,3'-thiodi(propionic acid)",111-17-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ad14858-5a16-46f1-b9dc-5fe1f61dbc52/documents/feb32250-8644-43f4-98ca-21ccac8d62bd_1fa8c657-a0bd-438c-95cc-8775d2c4f963.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "3,3'-thiodi(propionic acid)",111-17-1," oral LD50 > 2000 mg/kg bw (rat, equivalent to OECD TG 401) inhalation LC50 (4 h) >5.13 mg/L air (rat, OECD TG 403) dermal LD40 > 2000 mg/kg bw (rat, OECD TG 402) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ad14858-5a16-46f1-b9dc-5fe1f61dbc52/documents/fd62c5b0-504a-4ce7-a609-1ef77d8e1224_1fa8c657-a0bd-438c-95cc-8775d2c4f963.html,,,,,, "3,3'-thiodi(propionic acid)",111-17-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ad14858-5a16-46f1-b9dc-5fe1f61dbc52/documents/fd62c5b0-504a-4ce7-a609-1ef77d8e1224_1fa8c657-a0bd-438c-95cc-8775d2c4f963.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,3'-thiodi(propionic acid)",111-17-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ad14858-5a16-46f1-b9dc-5fe1f61dbc52/documents/fd62c5b0-504a-4ce7-a609-1ef77d8e1224_1fa8c657-a0bd-438c-95cc-8775d2c4f963.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,3'-thiodi(propionic acid)",111-17-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ad14858-5a16-46f1-b9dc-5fe1f61dbc52/documents/fd62c5b0-504a-4ce7-a609-1ef77d8e1224_1fa8c657-a0bd-438c-95cc-8775d2c4f963.html,,inhalation,LC50,5.13 mg/m3,adverse effect observed, "3-mercaptopropane-1,2-diol",96-27-5," NOAEL = 20 mg/kg bw/d (13 wk repeated dose toxicity study, oral, rat, NaTG) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51e844c8-512a-451b-a81d-00cee9483a5a/documents/79ffc007-ad30-4452-9f0a-dcaeb9b8db6b_48ed8863-cf60-4e24-a39b-773419c69168.html,,,,,, "3-mercaptopropane-1,2-diol",96-27-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51e844c8-512a-451b-a81d-00cee9483a5a/documents/79ffc007-ad30-4452-9f0a-dcaeb9b8db6b_48ed8863-cf60-4e24-a39b-773419c69168.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "3-mercaptopropane-1,2-diol",96-27-5," TG has an oral LD50 of 648 mg/kg bw. The percutaneous LD50 is 683 mg/bw. The 4-h LC50, read-across from GMT, is 0.51 mg/L ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51e844c8-512a-451b-a81d-00cee9483a5a/documents/21833cf7-5837-4c8b-bfa1-54cb3935baaf_48ed8863-cf60-4e24-a39b-773419c69168.html,,,,,, "3-mercaptopropane-1,2-diol",96-27-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51e844c8-512a-451b-a81d-00cee9483a5a/documents/21833cf7-5837-4c8b-bfa1-54cb3935baaf_48ed8863-cf60-4e24-a39b-773419c69168.html,,oral,LD50,648 mg/kg bw,adverse effect observed, "3-mercaptopropane-1,2-diol",96-27-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51e844c8-512a-451b-a81d-00cee9483a5a/documents/21833cf7-5837-4c8b-bfa1-54cb3935baaf_48ed8863-cf60-4e24-a39b-773419c69168.html,,dermal,LD50,673 mg/kg bw,adverse effect observed, "3-mercaptopropane-1,2-diol",96-27-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51e844c8-512a-451b-a81d-00cee9483a5a/documents/21833cf7-5837-4c8b-bfa1-54cb3935baaf_48ed8863-cf60-4e24-a39b-773419c69168.html,,inhalation,LC50,510 mg/m3,adverse effect observed, Mercaptoacetic acid,68-11-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f28d6b6d-a40e-46dc-ab54-f7a9e3c55878/documents/IUC5-eea3dccd-f5f3-41bc-b15d-ac15e9cacada_07b71e2a-3616-4e18-b510-183ab89bba4d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16 mg/kg bw/day,,rat Mercaptoacetic acid,68-11-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f28d6b6d-a40e-46dc-ab54-f7a9e3c55878/documents/IUC5-eea3dccd-f5f3-41bc-b15d-ac15e9cacada_07b71e2a-3616-4e18-b510-183ab89bba4d.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,145 mg/kg bw/day,,rat Mercaptoacetic acid,68-11-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f28d6b6d-a40e-46dc-ab54-f7a9e3c55878/documents/IUC5-c8cd5c64-4fa2-48a2-b83c-fe17ceb174da_07b71e2a-3616-4e18-b510-183ab89bba4d.html,,oral,LD50,73 mg/kg bw,adverse effect observed, Mercaptoacetic acid,68-11-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f28d6b6d-a40e-46dc-ab54-f7a9e3c55878/documents/IUC5-c8cd5c64-4fa2-48a2-b83c-fe17ceb174da_07b71e2a-3616-4e18-b510-183ab89bba4d.html,,dermal,LD50,848 mg/kg bw,adverse effect observed, Mercaptoacetic acid,68-11-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f28d6b6d-a40e-46dc-ab54-f7a9e3c55878/documents/IUC5-c8cd5c64-4fa2-48a2-b83c-fe17ceb174da_07b71e2a-3616-4e18-b510-183ab89bba4d.html,,inhalation,LC50,"1,388 mg/m3",adverse effect observed, 2-mercaptopropionic acid,79-42-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5f914a31-6091-41a4-87c1-f192a51f09d2/documents/3b099ca4-ab60-457b-b785-f772f8ecbc72_ca7850c8-9ce8-49bb-adce-719b61174253.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat 2-mercaptopropionic acid,79-42-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f914a31-6091-41a4-87c1-f192a51f09d2/documents/4fe0c994-324a-45b7-a261-92e230f16aba_ca7850c8-9ce8-49bb-adce-719b61174253.html,,oral,LD50,730 mg/kg bw,adverse effect observed, 2-mercaptopropionic acid,79-42-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f914a31-6091-41a4-87c1-f192a51f09d2/documents/4fe0c994-324a-45b7-a261-92e230f16aba_ca7850c8-9ce8-49bb-adce-719b61174253.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, thiourea; thiocarbamide,62-56-6,"Several repeated dose studies are available. Key study is Hartzell (1945/1942), a chronic (1y/3y) study in mice and rats. The effects level is supported by a 90day study in rats (Hazelton, 1987). In addition, data on short term exposure (Astwood, 1943; 1945), a 28-day dose range feeding study conducted by TNO (1979), a 28-day oral toxicity study by Korte and Greim (1981) and two sub-chronic drinking water studies conducted by TNO (1984a and b) are available.   The NOAEL for oral repeated dose toxicity was concluded to be 6.88 mg/kg bw/d, based on the key chronic toxicity study.   Further investigation will be conducted according to ECHA decision No. CCH-D-2114539794-36-01/F (19th January 2021). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): good ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/343c6648-d5aa-4337-9310-d4a74a11b97c/documents/IUC5-bcb8a3e3-df27-4307-8311-7a56dccc45f5_bef2aa57-9a37-4a81-b514-0517c23455d1.html,,,,,, thiourea; thiocarbamide,62-56-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/343c6648-d5aa-4337-9310-d4a74a11b97c/documents/IUC5-bcb8a3e3-df27-4307-8311-7a56dccc45f5_bef2aa57-9a37-4a81-b514-0517c23455d1.html,Chronic toxicity – systemic effects,oral,NOAEL,6.88 mg/kg bw/day,,rat thiourea; thiocarbamide,62-56-6,"There are three studies available on acute oral toxicity of thiourea.   These comprise a study according OECD 423 (Seibersdorf, 2010), a study similar to OECD 401 (TNO, 1975) and a study by Korte and Greim (1981). The acute dermal toxicity was assessed in two studies. One study was conducted by TNO (1978), the other by Korte and Greim (1981).The acute inhalation toxicity of thiourea was assessed in three studies at maximum attainable concentrations: Two studies by TNO (1977 and 1979) and a study by Korte and Greim (1981).In addition the intraperitoneal route was assessed by Giri (1979). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable study, Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): consistent; LC50 above maximum attainable concentration; LC10 at 195 mg/m3 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): consistent ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/343c6648-d5aa-4337-9310-d4a74a11b97c/documents/IUC5-53b331a3-fe18-4fa7-8356-17638d8d0d48_bef2aa57-9a37-4a81-b514-0517c23455d1.html,,,,,, thiourea; thiocarbamide,62-56-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/343c6648-d5aa-4337-9310-d4a74a11b97c/documents/IUC5-53b331a3-fe18-4fa7-8356-17638d8d0d48_bef2aa57-9a37-4a81-b514-0517c23455d1.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, thiourea; thiocarbamide,62-56-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/343c6648-d5aa-4337-9310-d4a74a11b97c/documents/IUC5-53b331a3-fe18-4fa7-8356-17638d8d0d48_bef2aa57-9a37-4a81-b514-0517c23455d1.html,,dermal,LD50,"2,800 mg/kg bw",no adverse effect observed, thiourea; thiocarbamide,62-56-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/343c6648-d5aa-4337-9310-d4a74a11b97c/documents/IUC5-53b331a3-fe18-4fa7-8356-17638d8d0d48_bef2aa57-9a37-4a81-b514-0517c23455d1.html,,inhalation,LC50,195 mg/m3,adverse effect observed, Thiram,137-26-8," Oral toxicity   Key, report number HLA 6111-127, subacute (4 weeks, mouse): NOAEL (oral, females) 300 ppm corresponding to approx. 59 mg/kg bw/day LOAEL (oral, males) 300 ppm corresponding to approx. 51 mg/kg bw/day (no NOAEL could be set for males   Key, report number HLA 6111-110, subchronic (13 weeks, rat): NOAEL (oral) 50 ppm corresponding to approx. 3.5 mg/kg bw/day (males) and approx. 4 mg/kg bw/day (females)   Key, report number HLA 6111-121, subchronic (13 weeks, dog): NOAEL (oral) 75 ppm, corresponding to approx. 2 mg/kg bw/day (males and females)   Key, report number HLA 6111-112, chronic (52 weeks, dog): NOAEL (oral) 30 ppm for males (corresponding to approx. 0.84 mg/kg bw/day), 90 ppm for females (corresponding to approx. 2.54 mg/kg bw/day)   Key, report number HLA 6111-113, combined chronic toxicity/carcinogenicity studies (52/104 weeks, rat): NOAEL (general systemic toxicity) 30 ppm, corresponding to approx. 1.5 mg/kg bw/day for males and 1.8 mg/kg bw/day for females)   Dermal toxicity Key, report number UCB 421/920767, subacute (21 days, rat): NOAEL (local, dermal) <100 mg/kg bw/day (females, males) NOAEL (general systemic toxicity, dermal) 300 mg/kg bw/day (females, males) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3c8f7f6-49b4-4163-a321-6a2ed1f3c102/documents/78cadd38-d318-4208-ae08-aa8efc202e55_fe38446d-1a0c-4b8f-b099-c081dcfa9e6d.html,,,,,, Thiram,137-26-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3c8f7f6-49b4-4163-a321-6a2ed1f3c102/documents/78cadd38-d318-4208-ae08-aa8efc202e55_fe38446d-1a0c-4b8f-b099-c081dcfa9e6d.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,300 mg/kg bw/day,,rabbit Thiram,137-26-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3c8f7f6-49b4-4163-a321-6a2ed1f3c102/documents/78cadd38-d318-4208-ae08-aa8efc202e55_fe38446d-1a0c-4b8f-b099-c081dcfa9e6d.html,Chronic toxicity – systemic effects,oral,NOAEL,0.84 mg/kg bw/day,,dog Thiram,137-26-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3c8f7f6-49b4-4163-a321-6a2ed1f3c102/documents/78cadd38-d318-4208-ae08-aa8efc202e55_fe38446d-1a0c-4b8f-b099-c081dcfa9e6d.html,Repeated dose toxicity – local effects,dermal,LOAEL,2.7 mg/cm2,adverse effect observed,rabbit Thiram,137-26-8," Oral key (EPA OPP 81 -1) rat: LD50 = 1800 mg/kg bw (females) and 3700 mg/kg bw (males)   Inhalation key (EPA OPP 81-3), rat: LC50 = >5.04 mg/L (males) and 3.46 mg/L (females)   Dermal key (EPA OPP 81-2), rabbit: LD50 > 2000 mg/kg bw (males and females) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3c8f7f6-49b4-4163-a321-6a2ed1f3c102/documents/ac73a64e-cf7f-4107-9ce7-08c3a5a36f33_fe38446d-1a0c-4b8f-b099-c081dcfa9e6d.html,,,,,, Thiram,137-26-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3c8f7f6-49b4-4163-a321-6a2ed1f3c102/documents/ac73a64e-cf7f-4107-9ce7-08c3a5a36f33_fe38446d-1a0c-4b8f-b099-c081dcfa9e6d.html,,oral,LD50,"1,800 mg/kg bw",adverse effect observed, Thiram,137-26-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3c8f7f6-49b4-4163-a321-6a2ed1f3c102/documents/ac73a64e-cf7f-4107-9ce7-08c3a5a36f33_fe38446d-1a0c-4b8f-b099-c081dcfa9e6d.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Thiram,137-26-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3c8f7f6-49b4-4163-a321-6a2ed1f3c102/documents/ac73a64e-cf7f-4107-9ce7-08c3a5a36f33_fe38446d-1a0c-4b8f-b099-c081dcfa9e6d.html,,inhalation,LC50,3.46 mg/L,adverse effect observed, Thymidine,50-89-5,"Repeated dose toxicity was tested using L-Thymidine in a six month toxicity study with three-month interim sacrifice and one month recovery groups in rats according to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents). The read-across approach to the L-isomer of the nucleoside is justified. No treatment related adverse effects were noted in any of the dose groups. The NOAEL was determined to be 1,000 mg/kg/day.According to REACH Annex VIII column 1 and 2, repeated dose toxicity testing via the inhalation and dermal routes was waived. Instead, data on repeated dose toxicity testing via the oral route is presented. The oral route is the most appropriate route of administration, having regard to the likely route of human exposure. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/addb200b-647f-4470-9921-e700e0208d39/documents/IUC5-44fc3822-9706-49be-b82e-8fd9da1fdf89_30f12533-c764-4476-9400-bedbfcd40daf.html,,,,,, Thymidine,50-89-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/addb200b-647f-4470-9921-e700e0208d39/documents/IUC5-44fc3822-9706-49be-b82e-8fd9da1fdf89_30f12533-c764-4476-9400-bedbfcd40daf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Thymidine,50-89-5,"The test item was assessed in acute oral toxicity and acute dermal toxicity studies according to respective EU Methods, OECD and OPPTS Guidelines. In none of the studies were any treatment related effects observed. The acute oral and acute dermal LD 50-values were determined to be > 2000 mg/kg bw (limit dose). The LD0 value in both studies was 2000 mg/kg bw. A study on acute inhalation toxicity was waived. Instead an acute inhalation LD0-value was calculated based on the results obtained in the acute oral toxicity study. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/addb200b-647f-4470-9921-e700e0208d39/documents/IUC5-0def33f3-9f6c-4131-8e71-efc1f7ec7c9e_30f12533-c764-4476-9400-bedbfcd40daf.html,,,,,, Thymol,89-83-8," Key, rat, 19 weeks, feeding study, NOAEL (systemic) = 10000 ppm thymol in the diet (= ca. 667 mg/kg bw/day) (Hagan, 1967) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ecc64dd5-c9fd-496a-8861-cd4a724af901/documents/IUC5-5ab674cb-0214-45bb-8fe8-0e4b1a216e2b_e2294b2d-f713-4033-8339-d839cf1ca146.html,,,,,, Thymol,89-83-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ecc64dd5-c9fd-496a-8861-cd4a724af901/documents/IUC5-5ab674cb-0214-45bb-8fe8-0e4b1a216e2b_e2294b2d-f713-4033-8339-d839cf1ca146.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,667 mg/kg bw/day,,rat Thymol,89-83-8," The endpoint 'Acute toxicity' is waived based on the classification as Skin Corr. 1B (H314). As supporting information several studies are available for the oral route and one study is available for the dermal route. The key results of these studies are as follows: oral Acute, oral, rat, LD50 = 980 mg/kg bw (Jenner, 1964) dermal Acute, dermal, rat, LD50 > 2000 mg/kg bw (Bomhard, 1986) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecc64dd5-c9fd-496a-8861-cd4a724af901/documents/IUC5-7d9d1e9b-4755-4ce1-a209-60dd8db04410_e2294b2d-f713-4033-8339-d839cf1ca146.html,,,,,, Thymol,89-83-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecc64dd5-c9fd-496a-8861-cd4a724af901/documents/IUC5-7d9d1e9b-4755-4ce1-a209-60dd8db04410_e2294b2d-f713-4033-8339-d839cf1ca146.html,,oral,LD50,980 mg/kg bw,adverse effect observed, Thymol,89-83-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecc64dd5-c9fd-496a-8861-cd4a724af901/documents/IUC5-7d9d1e9b-4755-4ce1-a209-60dd8db04410_e2294b2d-f713-4033-8339-d839cf1ca146.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Thyme, Thymus vulgaris, ext.",84929-51-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81f6956b-7ed4-41b3-ba9f-4a21617c0bd9/documents/e0b5ada0-8427-46e5-afd1-cb7310bc0e1e_29acf8f0-960b-4b9c-ac0e-4bc39e4dd4a8.html,,oral,discriminating dose,980 mg/kg bw,adverse effect observed, "Thyme, Thymus zygis, ext.",85085-75-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abcfbcbf-e389-4085-8cbd-a0354ca12416/documents/0ecf6ad9-ca2f-4e53-93bb-e69c1dbb0217_dfe162c9-d55f-45a1-a40a-38685843e6e0.html,,oral,discriminating dose,980 mg/kg bw,adverse effect observed, Tin,7440-31-5," A fourteen day range finding study for the guideline OECD 407  was performed in compliance with GLP. No indications of systemic toxicity were recorded following repeated administraton of 250, 500 or 1000 mg/kg bw/day of a formulation of tin metal powder. These results were then confirmed in the definitive 28 day subacute study, using 1000 mg/kg bw/day as the highest dose administered. A subacute (28 day) study was performed in compliance with GLP and to the standardised guideline OECD 407. Oral administration of the test material, tin metal powder (2-11 µm) to rats for a period of up to twenty-eight consecutive days at dose level of 30, 300 and 1000 mg/kg/day resulted in no treatment-related toxicological effects and for this reason the ""No Observed Effect Level"" (NOEL) was considered to be 1000 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce401a14-2d2e-4d60-b3ac-628d55b6ff51/documents/IUC5-7fbab08c-92fc-40d0-b599-a449778918f0_78529c6a-78f9-4ac8-a771-2cc3fd2180e9.html,,,,,, Tin,7440-31-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce401a14-2d2e-4d60-b3ac-628d55b6ff51/documents/IUC5-7fbab08c-92fc-40d0-b599-a449778918f0_78529c6a-78f9-4ac8-a771-2cc3fd2180e9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tin,7440-31-5," Oral In the GLP compliant key study (Dreher, 2009) performed to the current standardised guideline OECD 423, the acute median lethal oral dose level of the test article, Elemental Tin Powder (2 – 11 µm), was found to exceed 2000 mg/kg. This is confirmed by the results of the supporting study (Parcell, 1994), also performed in compliance with GLP and to the OECD guideline 423 in which the test material was found to be of low acute oral toxicity (LD50 >2000 mg/kg bw). Inhalation Gaunt, 2008, was provided as the key study for this endpoint. The study was performed in compliance with GLP and to the OECD guideline 403. The maximum practically achievable, respirable concentration of tin metal powder in the study was 4.75 mg/L. In the absence of adverse clinical signs or pathology findings it is considered that the LC50 is in excess of 5 mg/L. Dermal Bradshaw, 2009 was provided as the key study for this data requirement. The study was performed in compliance with GLP and to the standardised guideline OECD 402. Under the conditions of the study, the acute median lethal dermal dose of tin to Wistar rats was greater than 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce401a14-2d2e-4d60-b3ac-628d55b6ff51/documents/IUC5-a7526482-9536-45f6-9295-91c491cf6e00_78529c6a-78f9-4ac8-a771-2cc3fd2180e9.html,,,,,, Tin,7440-31-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce401a14-2d2e-4d60-b3ac-628d55b6ff51/documents/IUC5-a7526482-9536-45f6-9295-91c491cf6e00_78529c6a-78f9-4ac8-a771-2cc3fd2180e9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tin,7440-31-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce401a14-2d2e-4d60-b3ac-628d55b6ff51/documents/IUC5-a7526482-9536-45f6-9295-91c491cf6e00_78529c6a-78f9-4ac8-a771-2cc3fd2180e9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tin,7440-31-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce401a14-2d2e-4d60-b3ac-628d55b6ff51/documents/IUC5-a7526482-9536-45f6-9295-91c491cf6e00_78529c6a-78f9-4ac8-a771-2cc3fd2180e9.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Tin dioxide,18282-10-5,"From the studies, it is concluded that dietary exposure to levels of Tin (II) oxide and Tin (IV) dioxide up to 1% for 13 and 4 weeks respectively, did not induce any effect in rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b720f16e-cc7c-4dbc-91d5-442a2581e1c5/documents/IUC5-79c4003a-9a15-4a1b-86b5-9d02072ee79c_6454eca0-8292-4fef-9642-fc415fa8f41e.html,,,,,, Tin dioxide,18282-10-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b720f16e-cc7c-4dbc-91d5-442a2581e1c5/documents/IUC5-79c4003a-9a15-4a1b-86b5-9d02072ee79c_6454eca0-8292-4fef-9642-fc415fa8f41e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Tin dioxide,18282-10-5,"Oral, LD50 > 2,000 mg/kg bw, rat (EU Method B1)Inhalation, LC50 > 2.04 mg/L, rat (OECD 403, EU method B2) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b720f16e-cc7c-4dbc-91d5-442a2581e1c5/documents/IUC5-d811b22d-d47a-4de7-a81d-adebb761655b_6454eca0-8292-4fef-9642-fc415fa8f41e.html,,,,,, Tin dioxide,18282-10-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b720f16e-cc7c-4dbc-91d5-442a2581e1c5/documents/IUC5-d811b22d-d47a-4de7-a81d-adebb761655b_6454eca0-8292-4fef-9642-fc415fa8f41e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tin dioxide,18282-10-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b720f16e-cc7c-4dbc-91d5-442a2581e1c5/documents/IUC5-d811b22d-d47a-4de7-a81d-adebb761655b_6454eca0-8292-4fef-9642-fc415fa8f41e.html,,inhalation,LC50,2.04 mg/m3,no adverse effect observed, Titanium(4+) ethanolate,3087-36-3,Repeated toxicity testing was considered unnecessary since this substance undergoes immediate disintegration and there are sufficient data on cleavage product. The intrinsic properties of this substance after repeated administration are related to the main degradation product ethanol. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49a5e2a2-6575-4fab-87ef-b108c824e458/documents/a05474a9-aaf5-40d2-bde0-699b426537c3_6793d3f2-86c7-4886-9317-fb5345095549.html,,,,,, Titanium(4+) ethanolate,3087-36-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49a5e2a2-6575-4fab-87ef-b108c824e458/documents/a05474a9-aaf5-40d2-bde0-699b426537c3_6793d3f2-86c7-4886-9317-fb5345095549.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"11,600 mg/m3",,rat Titanium(4+) ethanolate,3087-36-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49a5e2a2-6575-4fab-87ef-b108c824e458/documents/a05474a9-aaf5-40d2-bde0-699b426537c3_6793d3f2-86c7-4886-9317-fb5345095549.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,250 mg/kg bw/day",,rat Titanium(4+) ethanolate,3087-36-3,"Oral:The oral LD50 (rat; female) > 2 000 mg/kg bwInhalation:There is no valid data available for acute inhalation toxicity for the target substance. LC50 for the ethanol, the degradation product, is > 60 000 ppm (114mg/l).Dermal:There is no valid data available for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49a5e2a2-6575-4fab-87ef-b108c824e458/documents/d03b75f2-d8ce-4768-a448-c447d08fb858_6793d3f2-86c7-4886-9317-fb5345095549.html,,,,,, Titanium(4+) ethanolate,3087-36-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49a5e2a2-6575-4fab-87ef-b108c824e458/documents/d03b75f2-d8ce-4768-a448-c447d08fb858_6793d3f2-86c7-4886-9317-fb5345095549.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Titanium(4+) ethanolate,3087-36-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49a5e2a2-6575-4fab-87ef-b108c824e458/documents/d03b75f2-d8ce-4768-a448-c447d08fb858_6793d3f2-86c7-4886-9317-fb5345095549.html,,inhalation,LC50,"114,000 mg/m3",no adverse effect observed, Titanium nitride,25583-20-4," Bioelution data for TiN support read-across between TiO2 and TiN. Details are given in the read-across report attached to section 13. Titanium dioxide did not show adverse effects in a chronic oral repeated dose toxicity study in mice and rats, with a NOAEL of 50,000 ppm (equivalent to 6,500 mg/kg bw/day in mice and 3,500 mg/kg bw/day in rats). The results from the bioelution tests with TiN together with the very low solublity of the test material in a transformation/dissolution test show that no bioavailability via the inhalation and dermal route can be expected. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5ce53dd-13c3-4750-8f64-36b91dee7a4e/documents/IUC5-78a36567-ed78-4d04-b002-73b780d2da0c_c18fe3d2-fdaf-47d2-8c29-ae94654069b4.html,,,,,, Titanium nitride,25583-20-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5ce53dd-13c3-4750-8f64-36b91dee7a4e/documents/IUC5-78a36567-ed78-4d04-b002-73b780d2da0c_c18fe3d2-fdaf-47d2-8c29-ae94654069b4.html,Chronic toxicity – systemic effects,oral,NOAEL,"3,500 mg/kg bw/day",,rat Titanium nitride,25583-20-4," The results from a bioelution assay demonstrated low titanium release from titanium nitride in simulated gastric fluid. Therefore, low bioavailability can be expected via the oral route. In a read-across study, titanium dioxide did not show adverse effects after chronic oral repeated dose exposure in mice and rats. In addition, the results from the bioelution test with TiN together with the very low solubility of the test material in a transformation/dissolution test lead to the conclusion that no to very low bioavailability can be expected via the inhalation and dermal route. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5ce53dd-13c3-4750-8f64-36b91dee7a4e/documents/IUC5-a9fa2ba3-1e39-4757-88d0-44f20f76ca26_c18fe3d2-fdaf-47d2-8c29-ae94654069b4.html,,,,,, Titanium tetrabutanolate,5593-70-4,Repeated toxicity testing was considered unnecessary since the target substance undergoes immediate disintegration and there are sufficient data on cleavage product for the most relevant exposure route. The intrinsic properties of this substance after repeated administration are related to the main degradation product n-butanol. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d6e5987-1300-4b89-8cef-aa464a301df3/documents/9f99f674-63cc-4a30-bdfb-379ab86aa0e6_bd6c8162-19fc-42d1-ac6f-744658d2b396.html,,,,,, Titanium tetrabutanolate,5593-70-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d6e5987-1300-4b89-8cef-aa464a301df3/documents/9f99f674-63cc-4a30-bdfb-379ab86aa0e6_bd6c8162-19fc-42d1-ac6f-744658d2b396.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Titanium tetrabutanolate,5593-70-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d6e5987-1300-4b89-8cef-aa464a301df3/documents/9f99f674-63cc-4a30-bdfb-379ab86aa0e6_bd6c8162-19fc-42d1-ac6f-744658d2b396.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,520 mg/m3",,rat Titanium tetrabutanolate,5593-70-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d6e5987-1300-4b89-8cef-aa464a301df3/documents/9f99f674-63cc-4a30-bdfb-379ab86aa0e6_bd6c8162-19fc-42d1-ac6f-744658d2b396.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,520 mg/m3",no adverse effect observed,rat Titanium tetrabutanolate,5593-70-4,"Oral:There is no reliable data available for acute oral toxicity for the target substance. This value comes from the analogue category member. Both the analogue substance (tetra-n-butyl titanate, polymer with water) and the target substance hydrolyze rapidly in aqueous solutions releasing n-butanol.The oral LD50 (rat; female) is greater than 2 000 mg/kg bwInhalation:There is no reliable data available for acute inhalation toxicity for the target substance. The LC50 (rat; male) for n-butanol, the degradation product, is > 20 100 mg/m3Dermal:There is no valid data available for acute dermal toxicity for the target substance.The dermal LD50 (rat; male, female) for the n-butanol, the degradation product, is 5 300 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d6e5987-1300-4b89-8cef-aa464a301df3/documents/d7f76e94-7bc9-4395-9a77-01c350c4cd69_bd6c8162-19fc-42d1-ac6f-744658d2b396.html,,,,,, Titanium tetrabutanolate,5593-70-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d6e5987-1300-4b89-8cef-aa464a301df3/documents/d7f76e94-7bc9-4395-9a77-01c350c4cd69_bd6c8162-19fc-42d1-ac6f-744658d2b396.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Titanium tetrabutanolate,5593-70-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d6e5987-1300-4b89-8cef-aa464a301df3/documents/d7f76e94-7bc9-4395-9a77-01c350c4cd69_bd6c8162-19fc-42d1-ac6f-744658d2b396.html,,dermal,LD50,"5,300 mg/kg bw",no adverse effect observed, Titanium tetrabutanolate,5593-70-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d6e5987-1300-4b89-8cef-aa464a301df3/documents/d7f76e94-7bc9-4395-9a77-01c350c4cd69_bd6c8162-19fc-42d1-ac6f-744658d2b396.html,,inhalation,LC50,"20,100 mg/m3",no adverse effect observed, "3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-ol",10191-41-0,"Repeated dose information was available for the structural analogues D- and D,L-alpha-tocopheryl acetate (vitamin E acetate). These vitamin E esters will be rapidly hydrolysed to the free alpha-tocopherol forms under physiological conditions. In summary, Vitamin E exerts low toxicity in repeated dose studies. The NOAEL of 500 mg/kg bw/d for D-alpha-tocopheryl acetate was based on a well conducted 90-day study in rat comparable to OECD guideline 408 (Abdo, 1986). In a chronic rat study with doses of 500, 1000 or 2000 mg/kg bw/d D,L-alpha-tocopherol acetate the animals showed at all dose levels spontaneous haemorrhages in several organs which was correctable by administration of Vitamin K3.The following repeated studies were also part of the assessment for this endpoint: 28-day studies (OECD 407) with D,L-alpha-tocopheryl acetate: gavage study in rats (Pfister, 1999; BASF AG, 1983)28-day study with D,L-alpha-tocopheryl acetate: feed study in dogs (BASF AG, 1982)2-year study (OECD 453): feeding study in rats with D,L-alpha-tocopheryl acetate supplemented with Vitamin K (Wheldon, 1978) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5295b601-4cac-40bf-831c-659ef89489d4/documents/IUC5-115e3dbf-1cfa-42ee-a11e-c5cb3a0efe96_ac89397f-c251-412a-8196-52609e469709.html,,,,,, "3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-ol",10191-41-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5295b601-4cac-40bf-831c-659ef89489d4/documents/IUC5-115e3dbf-1cfa-42ee-a11e-c5cb3a0efe96_ac89397f-c251-412a-8196-52609e469709.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-ol",10191-41-0,"For acute toxicity, the key studies based on D,L-alpha-tocopherol were used:- oral: limit study similar to OECD 401, pre-GLP (DSM, 1972)- dermal: acute toxicity test similar to OECD 402, pre-GLP (Buser, 1980) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5295b601-4cac-40bf-831c-659ef89489d4/documents/IUC5-3737da0b-e32c-42ca-bb2d-796a9c8efb66_ac89397f-c251-412a-8196-52609e469709.html,,,,,, Tocopherols,1406-66-2,"Repeated oral dose toxicity: - subchronic (90-day), rat (oral, gavage), NOAEL = 500 mg/kg bw- subacute (28-day), rat (oral, feeding), NOAEL ca. 1111 mg/kg bw- subacute (28-day), dog (oral, feeding), NOAEL >= 360 mg/kg bw ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/045d9715-b624-4bc1-ab5a-bb15904c8fd6/documents/IUC5-3460a227-6e8d-41fb-b8f5-7e3cb00d8563_30d8b4bf-3d90-4e51-a1c6-68c4c5abf96a.html,,,,,, Tocopherols,1406-66-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/045d9715-b624-4bc1-ab5a-bb15904c8fd6/documents/IUC5-3460a227-6e8d-41fb-b8f5-7e3cb00d8563_30d8b4bf-3d90-4e51-a1c6-68c4c5abf96a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Tocopherols,1406-66-2,"Oral LD50 (OECD guideline 401), rat = 7500 mg/kg bwRA: CAS 7695-91-2, LD50 (OECD guideline 401), rat > 10000 mg/kg bwDermal LD50 (OECD guideline 402), rabbit > 1000 mg/kg bw Read-across CAS: 59-02-9: Dermal LD50 (OECD guideline 402), rabbit = 5000 mg/kg bwAcute toxicity by inhalation was not tested according to Regulation (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/045d9715-b624-4bc1-ab5a-bb15904c8fd6/documents/IUC5-3bc03cc3-5354-44dc-81bd-22e123959370_30d8b4bf-3d90-4e51-a1c6-68c4c5abf96a.html,,,,,, Tocopherols,1406-66-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/045d9715-b624-4bc1-ab5a-bb15904c8fd6/documents/IUC5-3bc03cc3-5354-44dc-81bd-22e123959370_30d8b4bf-3d90-4e51-a1c6-68c4c5abf96a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Tocopherols,1406-66-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/045d9715-b624-4bc1-ab5a-bb15904c8fd6/documents/IUC5-3bc03cc3-5354-44dc-81bd-22e123959370_30d8b4bf-3d90-4e51-a1c6-68c4c5abf96a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, α-tocopherol,59-02-9,"Read-across CAS: 1406-66-2: Oral LD50 (OECD guideline 401), rat = 7500 mg/kg bwDermal LD50 (OECD guideline 402), rabbit = 5000 mg/kg bwAcute toxicity by inhalation was not tested according to Regulation (EC) No 1907/2006, Annex VII, Section 8.5, Column 2. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cffbe880-55aa-4ee0-8a81-b6abf0c0d419/documents/IUC5-55d8f7fb-dda0-4ed7-bc06-c514023f5c61_9a0071a1-59b4-4a38-b9c5-550475d68636.html,,,,,, α-tocopherol,59-02-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cffbe880-55aa-4ee0-8a81-b6abf0c0d419/documents/IUC5-55d8f7fb-dda0-4ed7-bc06-c514023f5c61_9a0071a1-59b4-4a38-b9c5-550475d68636.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, α-tocopherol,59-02-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cffbe880-55aa-4ee0-8a81-b6abf0c0d419/documents/IUC5-55d8f7fb-dda0-4ed7-bc06-c514023f5c61_9a0071a1-59b4-4a38-b9c5-550475d68636.html,,dermal,LD50,"5,000 ",no adverse effect observed, "3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-yl acetate",7695-91-2,"The NOAEL of 500 mg/kg bw/day was based on a well conducted 90-day study in rat comparable to OECD guideline 408 (Abdo, 1986).The following repeated studies were also part of the assessment for this endpoint: 28-day studies: BASF (1983); feed study in rats (OECD 407) and a feed study in dogs (dosing stopped after 28 day in an OECD 409 comparable study ; BASF,1982), Pfister (1999); study oral gavage in rats (GLP and OECD 407).90-day study: Pfannkuch (2000); oral gavage study in minipigs (GLP and OECD 409), supplemented with vitamin K , 2 -year study : Wheldon (1978); feed study in rats (OECD 453) supplemented with Vitamin K ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d1950a8-58dd-41c1-8219-7aaee9a080cc/documents/IUC5-969f7788-eca6-4223-b1a3-9be3e2436785_c4fa3417-66ca-4bdc-92bb-b177f314a056.html,,,,,, "3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-yl acetate",7695-91-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d1950a8-58dd-41c1-8219-7aaee9a080cc/documents/IUC5-969f7788-eca6-4223-b1a3-9be3e2436785_c4fa3417-66ca-4bdc-92bb-b177f314a056.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,, "3,4-dihydro-2,5,7,8-tetramethyl-2-(4,8,12-trimethyltridecyl)-2H-benzopyran-6-yl acetate",7695-91-2,"For acute toxicity, the key studies are:- oral: limit study of BASF 1977 (similar to OECD 401, pre-GLP)- dermal: acute toxicity test of Buser 1980 (similar to OECD 402, pre-GLP) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d1950a8-58dd-41c1-8219-7aaee9a080cc/documents/IUC5-d5fcb030-7cb0-4a82-8dc3-7cd79e14108d_c4fa3417-66ca-4bdc-92bb-b177f314a056.html,,,,,, α-tocopheryl hydrogen succinate,4345-03-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4abe74db-7d46-4b1c-9980-6359ca43d39f/documents/9e4a7ee1-7ffb-4092-8f15-80187dd8e151_674639e6-984a-4c2d-8d30-907bb1b50460.html,,oral,LD50,"7,000 mg/kg bw",no adverse effect observed, Toluene,108-88-3," Toluene exposure can produce central nervous system pathology in animals after high oral doses. Repeated inhalation exposure can produce ototoxicity in the rat and high concentrations are associated with local toxicity (nasal erosion). In humans neuropsychological effects and disturbances of auditory function and colour vision have been reported, particularly when exposures are not well controlled and/or associated with noisy environments. The NOAEC for subchronic oral toxicity in rats is 625 mg/kg/day based on neuropathology. The NOAEC for inhalation toxicity in the rat is 300 ppm (1131mg/m3) based on effects on body weight and mortality, with a LOAEC for local effects (nasal errosion) of 2261 mg/m3. SCOEL concluded there was a great deal of human data demonstrating no reliable evidence of neurological effects or mucosal irritation at or below 50 ppm (192 mg/m3), hence 50 ppm was an appropriate level for an 8 hr TWA. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89f31bda-0e16-488b-a598-6b719c64dbb3/documents/bceed111-ab2e-4ebe-99f9-e6c73c4a32f6_b2d8980d-dc67-4100-8ab9-6acfbc7380be.html,,,,,, Toluene,108-88-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89f31bda-0e16-488b-a598-6b719c64dbb3/documents/bceed111-ab2e-4ebe-99f9-e6c73c4a32f6_b2d8980d-dc67-4100-8ab9-6acfbc7380be.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,625 mg/kg bw/day,,rat Toluene,108-88-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89f31bda-0e16-488b-a598-6b719c64dbb3/documents/bceed111-ab2e-4ebe-99f9-e6c73c4a32f6_b2d8980d-dc67-4100-8ab9-6acfbc7380be.html,Chronic toxicity – systemic effects,inhalation,NOAEC,98 mg/m3,,other:human Toluene,108-88-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89f31bda-0e16-488b-a598-6b719c64dbb3/documents/bceed111-ab2e-4ebe-99f9-e6c73c4a32f6_b2d8980d-dc67-4100-8ab9-6acfbc7380be.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"2,261 mg/m3",adverse effect observed,rat Toluene,108-88-3," Toluene is of low acute toxicity by the oral (LD50 > 5000 mg/kg), dermal (LD50> 5000 mg/kg) and inhalation (4 hour LC50 >20 mg/L) routes. In humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen following acute exposure = 75 ppm. The NOAEC of 50 ppm (192 mg/m3) for acute neurobehavioural effects in humans is taken into account in the risk characterisation of acute neurotoxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89f31bda-0e16-488b-a598-6b719c64dbb3/documents/a117f7ff-eec8-48db-b1c6-8a829ab1e550_b2d8980d-dc67-4100-8ab9-6acfbc7380be.html,,,,,, Toluene,108-88-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89f31bda-0e16-488b-a598-6b719c64dbb3/documents/a117f7ff-eec8-48db-b1c6-8a829ab1e550_b2d8980d-dc67-4100-8ab9-6acfbc7380be.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Toluene,108-88-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89f31bda-0e16-488b-a598-6b719c64dbb3/documents/a117f7ff-eec8-48db-b1c6-8a829ab1e550_b2d8980d-dc67-4100-8ab9-6acfbc7380be.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Toluene,108-88-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89f31bda-0e16-488b-a598-6b719c64dbb3/documents/a117f7ff-eec8-48db-b1c6-8a829ab1e550_b2d8980d-dc67-4100-8ab9-6acfbc7380be.html,,inhalation,discriminating conc.,384 mg/m3,no adverse effect observed, Toluene-4-sulphonic acid,104-15-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53a8d2cc-59d1-4323-b77b-42be5957bde9/documents/f5613367-c7b1-4dee-aa7e-58514f8af6bd_0968060b-7b74-453b-8b93-326a62f26a05.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Toluene-4-sulphonic acid,104-15-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53a8d2cc-59d1-4323-b77b-42be5957bde9/documents/28534d5f-9b15-4ba7-bdce-9047add9e212_0968060b-7b74-453b-8b93-326a62f26a05.html,,oral,LD50,"1,410 mg/kg bw",no adverse effect observed, 2-methyl-p-phenylenediamine,95-70-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): good quality ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01c22908-1e4c-49c9-97c5-951df950272a/documents/IUC5-6d5eca06-8610-4182-b2fc-5e8e62187af7_a8138c35-6ad3-4902-8670-01d4b3b2bfbc.html,,,,,, 2-methyl-p-phenylenediamine,95-70-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01c22908-1e4c-49c9-97c5-951df950272a/documents/IUC5-6d5eca06-8610-4182-b2fc-5e8e62187af7_a8138c35-6ad3-4902-8670-01d4b3b2bfbc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat 2-methyl-p-phenylenediamine,95-70-5," A Klimisch-2-rated study on acute oral toxicity with target chemical toluene-2,5-diamine revealed a LD50 of 102 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01c22908-1e4c-49c9-97c5-951df950272a/documents/IUC5-1da46622-feb0-443d-9641-62909fa50630_a8138c35-6ad3-4902-8670-01d4b3b2bfbc.html,,,,,, 2-methyl-p-phenylenediamine,95-70-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01c22908-1e4c-49c9-97c5-951df950272a/documents/IUC5-1da46622-feb0-443d-9641-62909fa50630_a8138c35-6ad3-4902-8670-01d4b3b2bfbc.html,,oral,LD50,102 mg/kg bw,adverse effect observed, 2-methyl-p-phenylenediamine,95-70-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01c22908-1e4c-49c9-97c5-951df950272a/documents/IUC5-1da46622-feb0-443d-9641-62909fa50630_a8138c35-6ad3-4902-8670-01d4b3b2bfbc.html,,dermal,LD50,"3,519 mg/kg bw",adverse effect observed, 2-methyl-p-phenylenediamine,95-70-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01c22908-1e4c-49c9-97c5-951df950272a/documents/IUC5-1da46622-feb0-443d-9641-62909fa50630_a8138c35-6ad3-4902-8670-01d4b3b2bfbc.html,,inhalation,LC50,990 mg/m3,adverse effect observed, 2-methyl-p-phenylenediamine sulfate,615-50-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): good quality ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3e02763-a6c4-4d87-96d4-f6e77d18ea27/documents/IUC5-4e4478f4-cc5b-4f9f-89e2-dacd28f3442a_4cbe97cb-1a23-4a8b-ab54-71d4beb8b208.html,,,,,, 2-methyl-p-phenylenediamine sulfate,615-50-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3e02763-a6c4-4d87-96d4-f6e77d18ea27/documents/IUC5-4e4478f4-cc5b-4f9f-89e2-dacd28f3442a_4cbe97cb-1a23-4a8b-ab54-71d4beb8b208.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat 2-methyl-p-phenylenediamine sulfate,615-50-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliability 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): reliability 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): reliability 2 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3e02763-a6c4-4d87-96d4-f6e77d18ea27/documents/IUC5-f8534147-df9e-453c-8e98-8b8319b5cda5_4cbe97cb-1a23-4a8b-ab54-71d4beb8b208.html,,,,,, 2-methyl-p-phenylenediamine sulfate,615-50-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3e02763-a6c4-4d87-96d4-f6e77d18ea27/documents/IUC5-f8534147-df9e-453c-8e98-8b8319b5cda5_4cbe97cb-1a23-4a8b-ab54-71d4beb8b208.html,,oral,LD50,102 mg/kg bw,adverse effect observed, 2-methyl-p-phenylenediamine sulfate,615-50-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3e02763-a6c4-4d87-96d4-f6e77d18ea27/documents/IUC5-f8534147-df9e-453c-8e98-8b8319b5cda5_4cbe97cb-1a23-4a8b-ab54-71d4beb8b208.html,,dermal,LD50,"6,299 mg/kg bw",no adverse effect observed, 2-methyl-p-phenylenediamine sulfate,615-50-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3e02763-a6c4-4d87-96d4-f6e77d18ea27/documents/IUC5-f8534147-df9e-453c-8e98-8b8319b5cda5_4cbe97cb-1a23-4a8b-ab54-71d4beb8b208.html,,inhalation,LC50,990 mg/m3,adverse effect observed, Toluene-4-sulphonamide,70-55-3," There are several studies available for evaluation of which the 90-day in dogs,rats and mice are the longest in duration. The lowest NOAEL is derived from the 2 -generation study in rats, resulting to a NOAEL of 65 mg/kgbw/d (based on 1000 ppm in diet) due to transient effects on body weights at 3000 ppm. NOAEL 90-d rat = 3000 ppm (214 mg/kg/day for males; 248 mg/kg/day for females). NOAEL 90-d dog = 8000 ppm (260 mg/kg/day for males; 255 mg/kg/day for males). NOAEL 90-d mice = 2500 ppm (420 mg/kg/day for males; 380 mg/kg/day for females). NOAEL 90-d rat = 2500 ppm (200 mg/kg/day for males; 210 mg/kg/day for males). In SIDS dossier, a NOAEL of < 120 mg/kg bw/d is reported from an OECD 422 study. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aab2b57f-ada4-429a-99fa-acccb9e80914/documents/IUC5-31a3b4bc-e7fb-4cc6-be6c-cd1b5e255151_a1468101-a599-4c2b-b1f6-7c135ededddf.html,,,,,, Toluene-4-sulphonamide,70-55-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aab2b57f-ada4-429a-99fa-acccb9e80914/documents/IUC5-31a3b4bc-e7fb-4cc6-be6c-cd1b5e255151_a1468101-a599-4c2b-b1f6-7c135ededddf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,65 mg/kg bw/day,,rat Toluene-4-sulphonamide,70-55-3,p-TSA is of low acute toxicity. Acute oral LD50 is 2330 mg/kgbw and dermal toxicity much lower. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aab2b57f-ada4-429a-99fa-acccb9e80914/documents/IUC5-3f8cce4d-355a-4af9-b55a-5ac027aa3a2d_a1468101-a599-4c2b-b1f6-7c135ededddf.html,,,,,, Toluene-4-sulphonamide,70-55-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aab2b57f-ada4-429a-99fa-acccb9e80914/documents/IUC5-3f8cce4d-355a-4af9-b55a-5ac027aa3a2d_a1468101-a599-4c2b-b1f6-7c135ededddf.html,,oral,LD50,"2,330 mg/kg bw",adverse effect observed, Toluene-4-sulphonamide,70-55-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aab2b57f-ada4-429a-99fa-acccb9e80914/documents/IUC5-3f8cce4d-355a-4af9-b55a-5ac027aa3a2d_a1468101-a599-4c2b-b1f6-7c135ededddf.html,,dermal,discriminating dose,"7,500 mg/kg bw",no adverse effect observed, Toluene-2-sulphonamide,88-19-7," Weight of evidence. Based on the available data, the test item has a NOAEL = 20 mg/kg bw/d in rats. - Method according to OECD 422, GLP study. The NOAEL was determined to be 20 mg/kg bw/day in male and female rats. - Method according to OECD 407, GLP study. The NOAEL for the subacute oral repeated dose toxicity was determined to be 20 mg/kg bw/day in male and female rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf350d48-af41-4b9c-a070-4e658d78f008/documents/0020b7c1-7ffa-4395-853b-900ae85a6d5a_89215364-8e34-4f4e-9cee-6fcb5e538deb.html,,,,,, Toluene-2-sulphonamide,88-19-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf350d48-af41-4b9c-a070-4e658d78f008/documents/0020b7c1-7ffa-4395-853b-900ae85a6d5a_89215364-8e34-4f4e-9cee-6fcb5e538deb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat Toluene-2-sulphonamide,88-19-7," Acute Oral toxicity: Key study. Test method according to OECD 401, GLP study. The oral LD50 value for male rats was greater than 2000 mg/kg bw and between 1000 and 2000 mg/kg bw for females. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf350d48-af41-4b9c-a070-4e658d78f008/documents/7386efa2-9301-4c1b-b68f-515cbe0ca2ef_89215364-8e34-4f4e-9cee-6fcb5e538deb.html,,,,,, Toluene-2-sulphonamide,88-19-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf350d48-af41-4b9c-a070-4e658d78f008/documents/7386efa2-9301-4c1b-b68f-515cbe0ca2ef_89215364-8e34-4f4e-9cee-6fcb5e538deb.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, Tranexamic acid,1197-18-8,"Under the conditions of this study, the acute oral LD50 value of the test item Tranexamic Acid was found to be higher than 2000 mg/kg bw in female Crl:WI rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58598510-a926-4ab7-a54b-87fe23857c4d/documents/51e2602b-be0f-4e38-9c0e-16be768bf6a0_18a56c18-a72b-4084-91cb-5cbd6bd01ca8.html,,,,,, Tranexamic acid,1197-18-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58598510-a926-4ab7-a54b-87fe23857c4d/documents/51e2602b-be0f-4e38-9c0e-16be768bf6a0_18a56c18-a72b-4084-91cb-5cbd6bd01ca8.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, trans-hex-2-enal,6728-26-3," The available data for this endpoint include two oral LD50 studies and a maximum tolerated dose study in rats. The lowest reported value of 780 mg/kg bw (Gaunt et al., 1971) has been used for classification. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f831a9b-b991-4707-8115-453216fed4e7/documents/f11c83b6-4e84-4d50-a86d-0a3200bd0803_5184b841-323e-4561-bc9a-b8dd9ed18fde.html,,,,,, trans-hex-2-enal,6728-26-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f831a9b-b991-4707-8115-453216fed4e7/documents/f11c83b6-4e84-4d50-a86d-0a3200bd0803_5184b841-323e-4561-bc9a-b8dd9ed18fde.html,,oral,LD50,780 mg/kg bw,adverse effect observed, trans-hex-2-en-1-ol,928-95-0, An assessment on the acute oral toxicity of Trans-hex-2-en-1-ol was performed based on QSAR predictions supported by data on the substance and a suitable analogue. It was concluded that the substance is not acute toxic via the oral route. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d717629-41c5-486b-8ae2-c4aff9488c58/documents/63ed9fc4-b6e9-42e5-a0f4-a2457a23dbe5_180414f9-df4d-4721-bb08-761955527418.html,,,,,, trans-hex-2-en-1-ol,928-95-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d717629-41c5-486b-8ae2-c4aff9488c58/documents/63ed9fc4-b6e9-42e5-a0f4-a2457a23dbe5_180414f9-df4d-4721-bb08-761955527418.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, (E)-2-methylpent-2-en-1-oic acid,16957-70-3, The acute oral study does not need to be conducted because the substance is classified as corrosive to the skin. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab4dc59f-6957-4be3-b28b-34ee766a314c/documents/f710019f-e357-4aa4-8f6a-4031ff31e647_c5190cef-953a-41b7-80f4-7be70627ea58.html,,,,,, "2-Hepten-4-one, 5-methyl-, (2E)-",102322-83-8,"Oral (OECD 423), rat: LD50 cut-off value = 500 mg/kg bwDermal (OECD 402), rat: LD50 > 5000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5625c3b-bac3-4c9e-abd5-90ffb16131a9/documents/IUC5-aab05da8-b62d-40db-a1ec-f5fac63be835_ad937bf4-e02c-479e-97b5-8eae3d1b89ab.html,,,,,, "2-Hepten-4-one, 5-methyl-, (2E)-",102322-83-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5625c3b-bac3-4c9e-abd5-90ffb16131a9/documents/IUC5-aab05da8-b62d-40db-a1ec-f5fac63be835_ad937bf4-e02c-479e-97b5-8eae3d1b89ab.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "(E)-1-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2-buten-1-one",23726-91-2,"Acute toxicity: oral: LD50 > 2000 mg/kg bw (OECD 401 in rats; GLP, K, Rel.2) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01af8388-780b-4dda-8b41-a47a46691093/documents/IUC5-3fa172c5-bbc8-4bd5-a3df-b2300963912b_77b24108-3fdd-4a6b-abbd-17de7f2ed6e7.html,,,,,, "(E)-1-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2-buten-1-one",23726-91-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01af8388-780b-4dda-8b41-a47a46691093/documents/IUC5-3fa172c5-bbc8-4bd5-a3df-b2300963912b_77b24108-3fdd-4a6b-abbd-17de7f2ed6e7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "[1α(E),2β]-1-(2,6,6-trimethylcyclohex-3-en-1-yl)but-2-en-1-one",71048-82-3,"In a 28-day repeated-dose oral toxicity study with Delta-damascone a systemic NOAEL of 85 mg/kg bw has been derived based on the observed hepatoxicity at the next dose level. In a 90-day oral study with its structural analogue Alpha-iso-methylionone, a NOAEL of 30 mg/kg bw/day was established based on increases in plasma levels of creatinine, total protein and cholesterol (indicators of liver effects), increases in absolute and relative weights of the kidneys and spleen, and microscopic changes in thyroid and bone marrow at the next dose level. At the highest dose level also liver effects were seen at the 500 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The information of the two available studies are considered reliable and sufficiently adequate for the present dossier. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73f91a19-fac0-453b-8806-7b0c1a71c0ef/documents/IUC5-30837cd5-9e41-4863-9d78-619543eecf97_e2f487f2-eec2-4483-adbc-41f90354d1f6.html,,,,,, "[1α(E),2β]-1-(2,6,6-trimethylcyclohex-3-en-1-yl)but-2-en-1-one",71048-82-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73f91a19-fac0-453b-8806-7b0c1a71c0ef/documents/IUC5-30837cd5-9e41-4863-9d78-619543eecf97_e2f487f2-eec2-4483-adbc-41f90354d1f6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "[1α(E),2β]-1-(2,6,6-trimethylcyclohex-3-en-1-yl)but-2-en-1-one",71048-82-3,"Acute oral toxicity in mice: LD50 is 1400 mg/kg bw in an OECD 401 Acute dermal toxicity: LD50 => 1400 mg/kg bw based on the acute oral LD50. The dermal availability is not expected to exceed the oral availability. Therefore the LD50 via the dermal route can be estimated to be lower than the oral LD50, because we assume 10% absorption via the dermal route and 50% absorption via the oral route. Acute inhalation toxicity: LC50 value of 14000 mg/m³ was calculated for acute inhalation toxicity exceeding the saturated vapour concentration of 215 mg/m³. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information is adequate for the dossier. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73f91a19-fac0-453b-8806-7b0c1a71c0ef/documents/IUC5-08f7edd4-c8eb-4d37-9edc-161ac62e4370_e2f487f2-eec2-4483-adbc-41f90354d1f6.html,,,,,, "[1α(E),2β]-1-(2,6,6-trimethylcyclohex-3-en-1-yl)but-2-en-1-one",71048-82-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73f91a19-fac0-453b-8806-7b0c1a71c0ef/documents/IUC5-08f7edd4-c8eb-4d37-9edc-161ac62e4370_e2f487f2-eec2-4483-adbc-41f90354d1f6.html,,oral,LD50,"1,400 mg/kg bw",adverse effect observed, "(E)-1-(2,4,4-trimethyl-2-cyclohexen-1-yl)-2-buten-1-one",39872-57-6," Oral (OECD 401), rat: LD50: > 2000 mg/kg bw (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/268603d1-c548-4afc-8202-f20c841118ad/documents/20681c3f-d807-46e5-8b08-b2a7cdc2c71a_faedc3a1-5e94-4f83-b080-5c76b3ef9055.html,,,,,, "(E)-3,7,11-trimethyldodeca-1,6,10-trien-3-ol",40716-66-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Guideline study ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/985e8130-6e33-4a1f-8a26-85791b302c5e/documents/ec1df1ca-2fb6-4409-9773-fcefc6e2119c_2931d4e8-5a52-4a04-ae59-efe5f6149480.html,,,,,, "(E)-3,7,11-trimethyldodeca-1,6,10-trien-3-ol",40716-66-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/985e8130-6e33-4a1f-8a26-85791b302c5e/documents/ec1df1ca-2fb6-4409-9773-fcefc6e2119c_2931d4e8-5a52-4a04-ae59-efe5f6149480.html,,oral,LD50,"> 2,610 mg/kg bw",no adverse effect observed, Trehalose,99-20-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): two studies available covering the subcutaneous route. No fully adequate information available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): three studies present, reliability 1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ae0d8f50-accf-44c4-b461-4a3e85ea6d89/documents/3aa88c35-03d8-4654-8c02-428ad6689ee1_722e1e76-e0da-4a21-a41f-2e617d105db9.html,,,,,, Trehalose,99-20-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ae0d8f50-accf-44c4-b461-4a3e85ea6d89/documents/3aa88c35-03d8-4654-8c02-428ad6689ee1_722e1e76-e0da-4a21-a41f-2e617d105db9.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,500 mg/kg bw/day",,mouse Trehalose,99-20-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ae0d8f50-accf-44c4-b461-4a3e85ea6d89/documents/3aa88c35-03d8-4654-8c02-428ad6689ee1_722e1e76-e0da-4a21-a41f-2e617d105db9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"7,500 mg/kg bw/day",,mouse Trehalose,99-20-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): study performed according to acceptable Guideline, other information (repeated dose toxicity data) support conclusion Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): no study available. due to physico chemical properties, no study needed. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): two studies on repeated dose toxicity, subcutaneous route available and assessed reliable. Additionally observations from irritation testing support conclusion. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae0d8f50-accf-44c4-b461-4a3e85ea6d89/documents/ab062057-58ed-4c96-82e5-1e8e3f16472e_722e1e76-e0da-4a21-a41f-2e617d105db9.html,,,,,, Trehalose,99-20-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae0d8f50-accf-44c4-b461-4a3e85ea6d89/documents/ab062057-58ed-4c96-82e5-1e8e3f16472e_722e1e76-e0da-4a21-a41f-2e617d105db9.html,,oral,LD50,"16,000 mg/kg bw",no adverse effect observed, Trehalose,99-20-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae0d8f50-accf-44c4-b461-4a3e85ea6d89/documents/ab062057-58ed-4c96-82e5-1e8e3f16472e_722e1e76-e0da-4a21-a41f-2e617d105db9.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, "1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tri-C14-15-alkyl esters",222721-94-0," An OECD 407-study was conducted on the source substance1, 2-Hydroxypropane-1,2,3-tricarboxylic acid, tri (hexyl, octyl, decyl) ester. There was no indication that the substance was toxic in male or female rats after repeated oral exposure up to 1000 mg/kg bw/d. It is expected that the result is valid for the target substance 1,2,3 -Propanetricarboxylic acid, 2 -hydroxy-, tris(C14 -15 -alkyl) ester. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54efc56d-6429-4022-a210-e610f3bbcad9/documents/9a61aad5-e409-4665-984b-67f92f13dd62_32442f41-17bf-4706-95c3-a157b0530002.html,,,,,, "1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tri-C14-15-alkyl esters",222721-94-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54efc56d-6429-4022-a210-e610f3bbcad9/documents/9a61aad5-e409-4665-984b-67f92f13dd62_32442f41-17bf-4706-95c3-a157b0530002.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tri-C14-15-alkyl esters",222721-94-0," The substance 1,2,3 -Propanetricarboxylic acid, 2 -hydroxy-, tris(C14 -15) ester is practically non-toxic after acute exposition. LD50 oral > 5000 mg/kg LD50 dermal > 2000 mg/kg This is supported by studies of similar substances. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54efc56d-6429-4022-a210-e610f3bbcad9/documents/IUC5-dd430108-5c6c-4ee4-8291-8a19db5e390d_32442f41-17bf-4706-95c3-a157b0530002.html,,,,,, "1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tri-C14-15-alkyl esters",222721-94-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54efc56d-6429-4022-a210-e610f3bbcad9/documents/IUC5-dd430108-5c6c-4ee4-8291-8a19db5e390d_32442f41-17bf-4706-95c3-a157b0530002.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "1,2,3-Propanetricarboxylic acid, 2-hydroxy-, tri-C14-15-alkyl esters",222721-94-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54efc56d-6429-4022-a210-e610f3bbcad9/documents/IUC5-dd430108-5c6c-4ee4-8291-8a19db5e390d_32442f41-17bf-4706-95c3-a157b0530002.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Triacetin,102-76-1,"Repeated dose toxicity: Oral NOAEL (rat, m/f): 1000 mg/kg bw/day (OECD 422, GLP) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a46b9bc-f18f-44d7-9e6e-2558121a88ac/documents/IUC5-23b49f8f-ba2c-4923-bcdd-5d1bc4b20cc8_1c98e2f1-56e9-4d17-ab75-6a55ff421382.html,,,,,, Triacetin,102-76-1,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401, GLP)Acute toxicity: Inhalation LC50 (rat, m/f): > 1.7 mg/L (OECD 403, GLP) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a46b9bc-f18f-44d7-9e6e-2558121a88ac/documents/IUC5-3db0c2a5-e732-4528-b9fb-9a751cbdedbc_1c98e2f1-56e9-4d17-ab75-6a55ff421382.html,,,,,, Tributyl citrate,77-94-1,"Based on all pieces of available information it is clear that tributyl citrate is of very low toxicity after repeated administrations.1) A GLP test equivalent to OECD 408 resulted in a NOAEL (rat) of 1000 mg/kg bw . [Read-across data from tributyl-O-acetylcitrate (CAS 77-90-7)]2) A GLP test according to 875/318/EEC, 83/571/EEC and 91/507/EEC resulted in a NOAEL (rat, m) = 300 mg/kg bw/d and NOAEL (rat, f) = 1000 mg/kg bw/d. [Read-across data from tributyl-O-acetylcitrate (CAS 77-90-7)]3) Finkelstein, 1959: Tributyl citrate did not induce deleterious effects at concentration of 5%, but the 10%-diet tended to depress the growth, an effect which may be due to frequent diarrhoea. Sections taken from the treated animals were indistinguishable from the controls.4) Finkelstein, 1959: There were no symptoms of toxicity and the tests showed no abnormalities. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22d44fb7-9c64-43d5-bd9b-1d422f720555/documents/IUC5-9d1384f3-e7d7-4f06-8da5-e31234498fbd_16b24f7b-8786-45e8-bd24-7b215b46f7a6.html,,,,,, Tributyl citrate,77-94-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22d44fb7-9c64-43d5-bd9b-1d422f720555/documents/IUC5-9d1384f3-e7d7-4f06-8da5-e31234498fbd_16b24f7b-8786-45e8-bd24-7b215b46f7a6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tributyl citrate,77-94-1,Tributyl citrate is non toxic if administered to animals via the most relevant routes. The substance therefore does not need to be classified for acute toxicity.Acute toxicity: oral1) Finkelstein (1959): LD50 (rat) > 30 mL/kg bw [=31.3 g/kg bw (= 30 cm³; based on density of 1.0432)]2) Finkelstein (1959): LD50 (cat) > 50 mL/kg bwAcute toxicity: dermal2) A LD50 (rat) > 2000 mg/kg has been determined for ATEHC in a GLP test according to OECD 402. [Read-across data from acetyltri-2-ethylhexylcitrate (CAS 144-15-0)] ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22d44fb7-9c64-43d5-bd9b-1d422f720555/documents/IUC5-32c69d47-ec59-4aeb-9ea9-e06c6867af55_16b24f7b-8786-45e8-bd24-7b215b46f7a6.html,,,,,, Tributyl citrate,77-94-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22d44fb7-9c64-43d5-bd9b-1d422f720555/documents/IUC5-32c69d47-ec59-4aeb-9ea9-e06c6867af55_16b24f7b-8786-45e8-bd24-7b215b46f7a6.html,,oral,LD50,"31,300 mg/kg bw",no adverse effect observed, Tributyl citrate,77-94-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22d44fb7-9c64-43d5-bd9b-1d422f720555/documents/IUC5-32c69d47-ec59-4aeb-9ea9-e06c6867af55_16b24f7b-8786-45e8-bd24-7b215b46f7a6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4',4''-(1-methylpropanyl-3-ylidene)tris[6-tert-butyl-m-cresol]",1843-03-4,Key value determined by experimental 13 week diet study.NOAEL 500 ppm ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74efa363-9956-47c6-aa4e-93ac02cc1560/documents/IUC5-d8f1e57d-2e96-4379-bbd1-52ca446d1a17_15dc00fb-e41b-48cc-bb78-49d8229c8ab8.html,,,,,, "4,4',4''-(1-methylpropanyl-3-ylidene)tris[6-tert-butyl-m-cresol]",1843-03-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74efa363-9956-47c6-aa4e-93ac02cc1560/documents/IUC5-d8f1e57d-2e96-4379-bbd1-52ca446d1a17_15dc00fb-e41b-48cc-bb78-49d8229c8ab8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "4,4',4''-(1-methylpropanyl-3-ylidene)tris[6-tert-butyl-m-cresol]",1843-03-4,Key values determined by experimental study.Oral LD50 > 5000 mg/kg bwDermal LD50 > 7940 mg/kg ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74efa363-9956-47c6-aa4e-93ac02cc1560/documents/IUC5-3f29631e-79d6-4fe0-9a06-1de23a887af5_15dc00fb-e41b-48cc-bb78-49d8229c8ab8.html,,,,,, Tricalcium bis(orthophosphate),7758-87-4, There are currently no experimental data available to assess repeated dose toxicity for the test substance. A data waiver is set in place to justify that no further repeated dose toxicity testing is required. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f0fae12-6c7e-4099-a3ec-6a880a4016d6/documents/2198ca22-6a91-485f-8042-3bd144d1f15a_83c8143a-578c-4872-89d8-04e55da9cb21.html,,,,,, Tricalcium bis(orthophosphate),7758-87-4," Oral (OECD 420, RL1), rat: LD50 > 2000 mg/kg bw for females No data for acute dermal and inhalation toxicity are available for tricalcium bis(orthophosphate). Reliable data are available from the structural analogue calcium bis(dihydrogenorthophosphate) CAS 7758 -23 -8: Dermal (similar to OECD 402, RL2, RA CAS 7758 -23 -8), rabbit: LD50 > 2000 mg/kg bw (limit test) Inhalation (OECD 403, RL1, RA CAS 7758 -23 -8), rat: LC50 > 2.6 mg/L air (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f0fae12-6c7e-4099-a3ec-6a880a4016d6/documents/20acb6aa-fab3-493d-8814-450460c0c593_83c8143a-578c-4872-89d8-04e55da9cb21.html,,,,,, Tricalcium bis(orthophosphate),7758-87-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f0fae12-6c7e-4099-a3ec-6a880a4016d6/documents/20acb6aa-fab3-493d-8814-450460c0c593_83c8143a-578c-4872-89d8-04e55da9cb21.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tricalcium bis(orthophosphate),7758-87-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f0fae12-6c7e-4099-a3ec-6a880a4016d6/documents/20acb6aa-fab3-493d-8814-450460c0c593_83c8143a-578c-4872-89d8-04e55da9cb21.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tricalcium bis(orthophosphate),7758-87-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f0fae12-6c7e-4099-a3ec-6a880a4016d6/documents/20acb6aa-fab3-493d-8814-450460c0c593_83c8143a-578c-4872-89d8-04e55da9cb21.html,,inhalation,LC50,"2,600 mg/m3",no adverse effect observed, Glycerol trioctanoate,538-23-8, Oral (2-year oral gavage study): NOAEL male rat: 2390 mg/kg bw/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/456e79a5-7777-41f6-aa77-be5f88be918b/documents/8e3bf173-0010-4c05-9f7f-d92cc35dff58_2a2dc20f-3816-4811-8c73-634b0e486032.html,,,,,, Glycerol trioctanoate,538-23-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/456e79a5-7777-41f6-aa77-be5f88be918b/documents/8e3bf173-0010-4c05-9f7f-d92cc35dff58_2a2dc20f-3816-4811-8c73-634b0e486032.html,Chronic toxicity – systemic effects,oral,NOAEL,"2,390 mg/kg bw/day",,rat Glycerol trioctanoate,538-23-8," Oral (OECD 401, read across): LD50 male/female rat > 5000 mg/kg bw Inhalation (similar to OECD 403, read across): LC50 male rat > 1.86 mg/L air Dermal (OECD 402, read across): LD50 male/female rat > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/456e79a5-7777-41f6-aa77-be5f88be918b/documents/d0b12fef-33eb-47a3-9a52-5e06ca4d7993_2a2dc20f-3816-4811-8c73-634b0e486032.html,,,,,, "1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters",90218-76-1,"The subchronic oral toxicity of 1,2,4-Benzenetricarboxylic acid, decyl octyl ester was investigated in a well-conducted study in Sprague Dawley rats after daily oral administration at dose levels of 50, 200 and 500 mg/kg/day for 13 weeks and recovery from any treatment-related effects during a recovery period of 4 weeks. Signs of treatment-related effects of the test item were observed in males and females dosed at 200 and 500 mg/kg/day. These effects included some changes in clinical pathology parameters and some post mortem findings. The liver was identified as the main target organ on the basis of the organ weight data and histopathological findings. However, these changes were mild and fully reversible. The morphological aspect of the hepatocytic hypertrophy was consistent with proliferation of endoplasmic reticulum. As such, the hepatic effects were not considered to be adverse. No significant changes were observed in the animals dosed at 50 mg/kg/day. It can be concluded that the No Observed Adverse Effect Level (NOAEL) for this study was 500 mg/kg/day. In a subacute 28-day oral toxicity study in rats some treatment-related effects were evident in males and to a minor extent in females at the high dose level of 1000 mg/kg/d. The adrenals were identified as the main target organs, based on the post-mortem examination. The observed effects were completely reversible over a 2-week recovery period in the high dose animals. Only mild effects were observed in the animals (essentially males) dosed at 300 mg/kg/d, therefore this dose is expected to be NOAEL. No effects were observed at the low dose level (NOEL = 100 mg/kg/d). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A key study is identified. This study was conducted according to OECD TG 408 in accordance with GLP. It is a sub-chronic study using Sprague-Dawley rats where the test substance was administered daily in corn oil at concentrations of 50, 200 and 500 mg/kg/day for 13 weeks. The NOAEL was determined to be 500 mg/kg bw/day based on treatment related effects at 200 and 500 mg/kg/day. The main target organ was identified as the liver based on organ weight data and histopathological findings. These changes were noted as mild and fully reversible. In addition the morphological aspect of the hepatocytic hypertrophy was consistent with proliferation of the endoplasmic reticulum, such effects were not considered to be adverse. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ecc0a0d9-25eb-4ba4-923a-c03567dd50d6/documents/IUC5-2510c357-7552-43ec-b832-6ccd7d4243e3_b7002c8d-883e-4806-8998-461532c05ab1.html,,,,,, "1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters",90218-76-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ecc0a0d9-25eb-4ba4-923a-c03567dd50d6/documents/IUC5-2510c357-7552-43ec-b832-6ccd7d4243e3_b7002c8d-883e-4806-8998-461532c05ab1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters",90218-76-1,"The acute oral and dermal toxicity of 1,2,4 -benzenetricarboxylic acid, mixed decyl and octyl triesters has been determined in two OECD 401 and two OECD 402 studies. The oral and dermal LD50 were determined as > 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecc0a0d9-25eb-4ba4-923a-c03567dd50d6/documents/IUC5-d9ef1543-854d-401d-a978-087673464e1d_b7002c8d-883e-4806-8998-461532c05ab1.html,,,,,, "1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters",90218-76-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecc0a0d9-25eb-4ba4-923a-c03567dd50d6/documents/IUC5-d9ef1543-854d-401d-a978-087673464e1d_b7002c8d-883e-4806-8998-461532c05ab1.html,,oral,LD50,"> 3,000 mg/kg bw",no adverse effect observed, "1,2,4-Benzenetricarboxylic acid, mixed decyl and octyl triesters",90218-76-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecc0a0d9-25eb-4ba4-923a-c03567dd50d6/documents/IUC5-d9ef1543-854d-401d-a978-087673464e1d_b7002c8d-883e-4806-8998-461532c05ab1.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1,1,1-trichloroethane",71-55-6,"There are numerous acute oral and inhalation studies conducted in animals showing very low acute toxicity (LD 50’s in the region of 10,000 mg/kg or ppm). Dermal data is less prevailant but again the LD 50 is in the region of 15,000 mg/kg. A recent ATSDR review (2006) found lethal inhalation doses in humans to be in the region of 6000 to 20 000 ppm. 1,1,1-trichloroehtane can therefore be considered to be of no serious acute hazard. However, it should be noted that in humans exposure to 175 ppm for 3.5 hours results in reduced psychomotor abilities. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ea215f5-1585-4e59-a15b-bf2363777252/documents/IUC5-25c694f0-79ee-421d-b733-e1011ceb29df_3b6658ef-fb7d-4b67-9660-2d6a56edd4a4.html,,,,,, "1,1,1-trichloroethane",71-55-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ea215f5-1585-4e59-a15b-bf2363777252/documents/IUC5-25c694f0-79ee-421d-b733-e1011ceb29df_3b6658ef-fb7d-4b67-9660-2d6a56edd4a4.html,,oral,LD50,"10,300 mg/kg bw",, "1,1,1-trichloroethane",71-55-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ea215f5-1585-4e59-a15b-bf2363777252/documents/IUC5-25c694f0-79ee-421d-b733-e1011ceb29df_3b6658ef-fb7d-4b67-9660-2d6a56edd4a4.html,,dermal,LD50,"2,000 mg/kg bw",, "1,1,1-trichloroethane",71-55-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ea215f5-1585-4e59-a15b-bf2363777252/documents/IUC5-25c694f0-79ee-421d-b733-e1011ceb29df_3b6658ef-fb7d-4b67-9660-2d6a56edd4a4.html,,inhalation,LC50,"14,250 mg/m3",, "2,2,2-trichloro-1-phenylethyl acetate",90-17-5,"  Repeated dose toxicity: Oral OECD 407 study (GLP) with the substance: NOAEL in both male and female rats was determined to be 1000 mg/kg bw/day upon 28 days of treatment by oral gavage. OECD 408 study (GLP) with the substance: NOAEL in both male and female rats was determined to be 1000 mg/kg bw/day upon 90 days of treatment by oral gavage.   Repeated dose toxicity: Inhalation 2,2,2-trichloro-1-cyclohexylethyl) acetate (CAS no 90-17-5) has very low vapor pressure of 0.000976 mm Hg at 25°C. So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely. Also, the particle size distribution was determined in the range of 150 micron to 53 micron. The acute inhalationtoxicity value for the test chemical is >5 mg/L. Therefore this end point for repeated dose toxicity by inhalation route is considered for waiver.   Repeated dose toxicity: Dermal The Sub-acute Dermal toxicity study of the test chemical was conducted in wistar albino rats. Fifty healthy wistar albino rats were acclimatized for standard laboratory condition for period of one week. After acclimatization animal were divided into five groups (one control and four treated) each having five male and five female. All the animals were prepared 24 hrs prior to application of test compound. The test substance applied uniformly 125, 500 and 1500 mg/kg b.wt for at least 6 hours per day on a 7-day per week basis. A reversal group was also maintained in same manner at the highest test dose level 1500 mg/kg b.wt for period of 42 days.All the parameters were examined. No adverse effect on general health, growth, behavioural, neurological, haematological, clinical chemistry and urinalysis parameters, organ weights and gross and microscopic changes of the tissues/organs of the rats treated up to the dose level of 500 mg/kg body weight. Based on the findings of this study, the no observed adverse effect level (NOAEL) of the test chemical in rats was considered to be 500 mg/kg body weight and the No Observed Effect Level (NOEL) was considered to be 125 mg/kg b.wt. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad6cb1b3-a760-4bce-a38e-8cef902017d9/documents/5394e58f-ace5-4f12-a36f-1487f662a161_2804d440-54b9-49d3-b992-590bfe1d77ea.html,,,,,, "2,2,2-trichloro-1-phenylethyl acetate",90-17-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad6cb1b3-a760-4bce-a38e-8cef902017d9/documents/5394e58f-ace5-4f12-a36f-1487f662a161_2804d440-54b9-49d3-b992-590bfe1d77ea.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rat "2,2,2-trichloro-1-phenylethyl acetate",90-17-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad6cb1b3-a760-4bce-a38e-8cef902017d9/documents/5394e58f-ace5-4f12-a36f-1487f662a161_2804d440-54b9-49d3-b992-590bfe1d77ea.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2,2-trichloro-1-phenylethyl acetate",90-17-5,"  Acute oral toxicity: The acute oral toxicity dose (LD50) for target chemical was considered based on different experimental studies conducted on rats and mice, the LD50 values were considered in between 5000-10000 mg/kg bw in mice, and 6800 mg/kg bw in rats. These studies concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute oral toxicity.   Acute Inhalation Toxicity:The acute inhalation toxicity dose (LC50) for test chemical was considered based on experimental study conducted on rats, the LC50 value was considered to be >5 mg/L (>5000 mg/m3) in rats. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute inhalation toxicity.   Acute Dermal toxicity:The acute dermal toxicity dose (LD50) for test chemical was considered based on experimental study conducted on rats and rabbits, the LD50 value was considered to be >2000 mg/kg bw in rats, and rabbits. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad6cb1b3-a760-4bce-a38e-8cef902017d9/documents/6179a8bb-79ac-42cb-9f3f-b4a3ff7a8173_2804d440-54b9-49d3-b992-590bfe1d77ea.html,,,,,, "2,2,2-trichloro-1-phenylethyl acetate",90-17-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad6cb1b3-a760-4bce-a38e-8cef902017d9/documents/6179a8bb-79ac-42cb-9f3f-b4a3ff7a8173_2804d440-54b9-49d3-b992-590bfe1d77ea.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,2,2-trichloro-1-phenylethyl acetate",90-17-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad6cb1b3-a760-4bce-a38e-8cef902017d9/documents/6179a8bb-79ac-42cb-9f3f-b4a3ff7a8173_2804d440-54b9-49d3-b992-590bfe1d77ea.html,,dermal,LD50,200 mg/kg bw,no adverse effect observed, "2,2,2-trichloro-1-phenylethyl acetate",90-17-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad6cb1b3-a760-4bce-a38e-8cef902017d9/documents/6179a8bb-79ac-42cb-9f3f-b4a3ff7a8173_2804d440-54b9-49d3-b992-590bfe1d77ea.html,,inhalation,LC50,5 mg/m3,no adverse effect observed, Triclocarban,101-20-2," Repeated dose toxicity: Oral Repeated dose chronic/carcinogenicity study was conducted to determine the toxic nature of the test chemical. The study was performed using male and female CD rats for 2 years. The test chemical was mixed with feed and used at dose level of 0, 25, 75 or 250 mg/Kg/day. During the study period, the animals were observed for mortality, clinical signs, body weight and food consumption changes, ophthalmology, hematology, clinical chemistry, urinalysis, gross pathology and histopathology. During the study, no treatment related mortality was noted. No physical observations were noted which could be attributed were to treatment. During 64-86 weeks, there was an overall increase in the number of control and treated males which exhibited varying degrees of emaciation, labored breathing and rales. The mean body weights of 250 mg/Kg/day males and 75 and 250 mg/Kg/day females were lower than the controls during most of the study. However, differences from control never exceeded 9 and 12% in the females and 6% in the males. The mean food consumption displayed normal variability, and was comparable to that of control. No ocular abnormalities attributed to test chemical treatment were noted. Slight decreases were observed in mean hemoglobin, hematocrit and erythrocyte counts in the high-dose males throughout the study. These decreases were associated with an increased mean reticulocyte count at termination. Less marked decreases in mean hemoglobin, hematocrit and erythrocyte counts were noted in the mid-dose males at 6 and l2 months. The mean erythrocyte counts of the low-dose males was also slightly reduced at 12 months. Mean reticulocyte counts were considered unremarkable in the low- and mid-dose males at termination. Mean total leukocyte counts were slightly elevated in the 25 and 75 mg/Kg/day dose males at 6 months, in the 25, 75 and 250 mg/Kg/day dose males at 12 months and in the high-dose males at termination. In the females, mean hemoglobin values and erythrocyte counts were reduced for the 75 and 250 mg/Kg/day dose groups at 6 months and for the 250 mg/Kg/day group at 12 and 20 months and termination. Mean hematocrit values were slightly reduced in the high-dose females at 6 and 20 months and termination. Mean alkaline phosphatase levels were slightly elevated in the 75 and 250 mg/Kg/day dose males at 12 months and at termination. Mean blood urea nitrogen levels were slightly increased in the high-dose males at all study intervals. Mean total bilirubin values were slightly increased in the high-dose females at termination. Mean absolute testes weights, testes/body weight ratios and testes/brain weight ratios were elevated in the high-dose males at 6 and 12 months, but not at termination. Mean absolute and relative (to body and brain weights) spleen weights were elevated in the 75 and 250 mg/Kg/day dose males at all necropsy intervals. Increased Spleen weights were observed in the 75 and 250 mg/Kg/day dose females at 6, 12 and 20 months and at termination and in the 25 mg/Kg/day dose females at termination. Mean liver weights (absolute, liver/body weight and liver/brain weight ratios) were increased in the mid- and high-dose males at 6 and 12 months and in the 25, 75 and 250 mg/Kg/day dose males at termination. Mean liver weight increases were also observed in the 75 and 250 mg/Kg/day dose females at 6 and 12 months and in all treated females at 20 months and termination. Mean absolute and relative adrenal weights were increased in the high-dose females at 12 months, in the 25, 75 and 250 mg/Kg/day dose females at 20 months and termination and in the high-dose males at termination. Mean absolute and relative heart weights were increased in the 250 mg/Kg/day males at 12 months and at termination. Compound-related pathological changes were seen grossly in the 250 mg/Kg/day males only, and microscopically in the 75 and 250 mg/Kg/day dose males and females. Grossly, flaccidity and decrease in size of the testes were shown by a large number of 250 mg/Kg/day dose males. Microscopically significant findings were seen in the testes/epididymides, liver, kidneys, spleen, bone marrow and mesenteric lymph nodes. The microscopic pathological changes consisted of degeneration of seminiferous tubules; enlargement of epididymal secretory epithelium; decrease or absence of sperm in epididymal ducts; hepatocellular hypertrophy; brown pigment in Kupffer‘s cells; cholangiofibrosis; brown pigment in cytoplasm of proximal convoluted tubules; splenic congestion; hypercellularity and congestion of bone marrow. The most common findings in male rats dying at 17-19 months of study were pulmonary consolidation and edema with pus-like material on the pleural surface grossly, and acute multifocal suppurative bronchopneumonia microscopically. No morphologic evidence of the carcinogenic potential of the test chemical was observed. Based on findings of the study, the no observed adverse effect level (NOAEL) is considered to be 25 mg/Kg/day when male and female rats were exposed to the test chemical for 2 years.  Repeated dose toxicity: Inhalation The test substance Triclocarban has very low vapor pressure (0.00000000361 mmHg) and high melting point, so the potential for the generation of inhalable vapours of Triclocarban is low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and therefore this end point for repeated dose toxicity by inhalation route of exposure was considered for waiver.   Repeated dose toxicity: Dermal The acute toxicity value for Triclocarban (as provided in section 7.2.1) is >2000 mg/kg body weight. Thus, it is expected that Triclocarban shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Triclocarban shall exhibit repeated dose toxicity by the dermal route. Hence this end point for repeated dose toxicity by dermal route of exposure was considered for waiver ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/614e0d47-94a9-49f4-82f4-74fcdc1b42c6/documents/9c01b9f7-5a35-4055-b7e5-193ed768c9d4_5d6c8e96-5928-4d60-8bb7-57b92c9d4e6c.html,,,,,, Triclocarban,101-20-2,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/614e0d47-94a9-49f4-82f4-74fcdc1b42c6/documents/9c01b9f7-5a35-4055-b7e5-193ed768c9d4_5d6c8e96-5928-4d60-8bb7-57b92c9d4e6c.html,Chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Triclocarban,101-20-2," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The studies concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to low vapour pressure of the test chemical, which is reported to be 4.81E-9 hPa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the given test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/614e0d47-94a9-49f4-82f4-74fcdc1b42c6/documents/a6a9a5dd-cdeb-4f2f-a5c5-6857d301a3c7_5d6c8e96-5928-4d60-8bb7-57b92c9d4e6c.html,,,,,, Triclocarban,101-20-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/614e0d47-94a9-49f4-82f4-74fcdc1b42c6/documents/a6a9a5dd-cdeb-4f2f-a5c5-6857d301a3c7_5d6c8e96-5928-4d60-8bb7-57b92c9d4e6c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Triclocarban,101-20-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/614e0d47-94a9-49f4-82f4-74fcdc1b42c6/documents/a6a9a5dd-cdeb-4f2f-a5c5-6857d301a3c7_5d6c8e96-5928-4d60-8bb7-57b92c9d4e6c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Triclosan,3380-34-5,"Several studies on the toxicity of triclosan in different species under repeated administration conditions are available for the oral, the dermal and the inhalation route.For the repeated oral route of exposure, following studies were retained as key studies:A 28-day study with mouse according to OECD TG 407 (Ciba-Geigy Ltd 864005).A 13-week study with hamster according to OECD TG 408 (RCC 356490)A 90-day study with dog with a conduct similar to OECD TG 409 (LPD 8/70)A 90-week study with hamster according to OECD TG 451 (HLS Ltd CBG 756/972896)A 2-year combined toxicity/carcinogenicity study with rat according to OECD TG 453 (Ciba-Geigy Corp 85152).Following studies served as support:A 90-day study with mouse according to EPA OPP 82-1 (Hazleton HWA 483-287)A 90-day study with rat with a conduct similar to OECD TG 408 (Litton Bionetics Inc. 22188)A 4- and 13-week study with baboon conducted prior to the implementation of TG (HRC 2736/69/162)For the repeated dermal route of exposure, the following study was retained as key study:A 90-day study with rat according to EPA OPP 82-3 (Exxon Biomedical Sciences Inc 139910B)For the repeated inhalation route of exposure, the following study will be mentioned despite the fact that the study was discarded:A 21-day study with rat with a conduct similar to OECD TG 412 (Ciba Geigy Ltd Siss. 3725) ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/eaece6f9-82d9-4293-9863-343538b9e0b1/documents/fce66ee5-fea0-421d-90e2-275da8148faa_23d85bf8-bb2e-47c1-8389-f2e5c3f308e0.html,,,,,, Triclosan,3380-34-5,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/eaece6f9-82d9-4293-9863-343538b9e0b1/documents/fce66ee5-fea0-421d-90e2-275da8148faa_23d85bf8-bb2e-47c1-8389-f2e5c3f308e0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,"hamster, Syrian" Triclosan,3380-34-5,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/eaece6f9-82d9-4293-9863-343538b9e0b1/documents/fce66ee5-fea0-421d-90e2-275da8148faa_23d85bf8-bb2e-47c1-8389-f2e5c3f308e0.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,80 mg/kg bw/day,,rat Triclosan,3380-34-5,"Three acute toxicity studies are available for each of the oral, dermal and inhalative route of exposure.Following studies were selected as key studies:The acute oral toxicity of triclosan was tested in a rat study according to the US FIFRA §81-1 test guideline which in principle was similar to the OECD TG 401 (Product Safety Labs 2800). The acute dermal toxicity of triclosan was tested in rabbit according to the method described by Noakes & Anderson (1969), which was in general compliance with OECD 402 (Ciba-Geigy Ltd 800761).The LD50 obtained from these two studies were as follows:Acute oral toxicity (rat): LD50 LD50 > 5000 mg/kg bw (both sexes) Acute dermal toxicity (rabbit): LD50 > 6000 mg/kg bw (both sexes) The acute inhalation needed to be discarded because on unadequate test system since triclosan was dissolved into ethanol for aerosolization and this is not a representative exposure system for human hazard assessement because triclosan is a solid, powdered substance. Exposures during manufacturing or formulation activity would be a dust, if any, and not to a fully respirable aerosol of triclosan in ethanol. Thus, the study is considered as not reliable for hazard assessment and classification.Nevertheless and for information only, this acute inhalation toxicity (rat, 4 h exposure) resulted in LC50 = 0.436 mg a.i./L air (both sexes). ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eaece6f9-82d9-4293-9863-343538b9e0b1/documents/fa919531-960e-4f4f-a623-7166a46581e6_23d85bf8-bb2e-47c1-8389-f2e5c3f308e0.html,,,,,, Tris(methylphenyl) phosphate,1330-78-5, Assessment of subchronic exposure by oral route is discussed below. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/87ae49a8-8aca-452c-8044-07c03d617e09/documents/IUC5-8be73b59-3171-4946-8bf1-93de38a508d9_a2b35b4e-77d9-44a0-97cd-9692bfd430ac.html,,,,,, Tris(methylphenyl) phosphate,1330-78-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/87ae49a8-8aca-452c-8044-07c03d617e09/documents/IUC5-8be73b59-3171-4946-8bf1-93de38a508d9_a2b35b4e-77d9-44a0-97cd-9692bfd430ac.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,50 mg/kg bw/day,,mouse Tris(methylphenyl) phosphate,1330-78-5," Oral, inhalation and dermal acute toxicity are all considered. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87ae49a8-8aca-452c-8044-07c03d617e09/documents/IUC5-7ad814b7-6fea-4ee0-91a2-5ae7fdd169e2_a2b35b4e-77d9-44a0-97cd-9692bfd430ac.html,,,,,, Tris(methylphenyl) phosphate,1330-78-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87ae49a8-8aca-452c-8044-07c03d617e09/documents/IUC5-7ad814b7-6fea-4ee0-91a2-5ae7fdd169e2_a2b35b4e-77d9-44a0-97cd-9692bfd430ac.html,,oral,LD50,"15,750 mg/kg bw",no adverse effect observed, Tris(methylphenyl) phosphate,1330-78-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87ae49a8-8aca-452c-8044-07c03d617e09/documents/IUC5-7ad814b7-6fea-4ee0-91a2-5ae7fdd169e2_a2b35b4e-77d9-44a0-97cd-9692bfd430ac.html,,dermal,LD50,"3,700 mg/kg bw",no adverse effect observed, Tris(methylphenyl) phosphate,1330-78-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87ae49a8-8aca-452c-8044-07c03d617e09/documents/IUC5-7ad814b7-6fea-4ee0-91a2-5ae7fdd169e2_a2b35b4e-77d9-44a0-97cd-9692bfd430ac.html,,inhalation,LC50,5.2 mg/m3,no adverse effect observed, Tricyclodecanedimethanol,26896-48-0,"The subchronic NOAEL was 1000 mg/kg bw/day in an OECD 408 guideline study using male and female rats, and there were no adverse effects noted on the male and female reproductive organs, oestrous cycle, and sperm parameters. This is in line with the results of a screening study. In a combined oral repeated dose toxicity study (28 d) with a reproduction/developmental toxicity screening test under GLP conditions (OECD TG 422), the subacute parental NOAEL of octahydro-4,7-methano-1H-indenedimethanol (TCD Alcohol DM) was 600 mg/kg bw/day.The vapour pressure of TCD-Alcohol DM is determined to be < 1 hPa (sect. 4.6). Atmosphere concentrations attainable under ambient conditions are assessed to be too low to exert toxic effects. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2888e196-1317-4776-85b5-d27f52cfbad4/documents/IUC5-1900727c-9c2f-4ff2-978b-4f9bdf1a2ae1_5e31fd49-bbfb-476e-b4d4-58960d7f7182.html,,,,,, Tricyclodecanedimethanol,26896-48-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2888e196-1317-4776-85b5-d27f52cfbad4/documents/IUC5-1900727c-9c2f-4ff2-978b-4f9bdf1a2ae1_5e31fd49-bbfb-476e-b4d4-58960d7f7182.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tricyclodecanedimethanol,26896-48-0,"The oral LD50 (females) of octahydro-4,7-methano-1H-indenedimethanol (TCD-Alcohol DM) was determined to be 2250 mg/kg bw (95% C.I. 2132 - 2374 mg/kg bw) (Hollander/Hoechst AGa, 1975).The dermal LD50 of octahydro-4,7-methano-1H-indenedimethanol (TCD-Alcohol DM) was determined to be > 10000 mg/kg bw (LD0 = 10000 mg/kg bw; Collier/Safepharm, 1981a).Inhalational toxicity is not expected due to the low vapor pressure of octahydro-4,7-methano-1H-indenedimethanol (TCD-Alcohol DM) (data waiving: study not required according to Annex VIII No 8.5.2, column 2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2888e196-1317-4776-85b5-d27f52cfbad4/documents/IUC5-8de07613-4996-4381-9084-5ae132dcba7e_5e31fd49-bbfb-476e-b4d4-58960d7f7182.html,,,,,, Tricyclodecanedimethanol,26896-48-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2888e196-1317-4776-85b5-d27f52cfbad4/documents/IUC5-8de07613-4996-4381-9084-5ae132dcba7e_5e31fd49-bbfb-476e-b4d4-58960d7f7182.html,,oral,LD50,"2,250 mg/kg bw",adverse effect observed, Tricyclodecanedimethanol,26896-48-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2888e196-1317-4776-85b5-d27f52cfbad4/documents/IUC5-8de07613-4996-4381-9084-5ae132dcba7e_5e31fd49-bbfb-476e-b4d4-58960d7f7182.html,,dermal,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "(octahydro-4,7-methano-1H-indenediyl)bis(methylene) diacrylate",42594-17-2,"Under the experimental conditions of the OECD 407, following daily administration of Tricyclodecane dimethanol diacrylate for 4 weeks by oral route to male and female Sprague-Dawley rats at dose levels of 100, 300 or 1000 mg/kg/day in corn oil, the No Observed Adverse Effect Level (NOAEL) was considered to be at 1000 mg/kg/day in absence of adverse effects at this dose.A 90-day repeated toxicity study is proposed in this dossier. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The 28-d study is considered to be reliable with a klimisch score of 1. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6fbb52a3-ef6f-428d-831f-1adbdc056e76/documents/IUC5-27fb00b6-db45-4d3b-acf4-a2ad964684f1_4148abe9-b5c9-4101-9e2a-d3e43b04dde0.html,,,,,, "(octahydro-4,7-methano-1H-indenediyl)bis(methylene) diacrylate",42594-17-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6fbb52a3-ef6f-428d-831f-1adbdc056e76/documents/IUC5-27fb00b6-db45-4d3b-acf4-a2ad964684f1_4148abe9-b5c9-4101-9e2a-d3e43b04dde0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "(octahydro-4,7-methano-1H-indenediyl)bis(methylene) diacrylate",42594-17-2,Acute studies are available by oral and dermal route and showed no death at the maximal dose of 2000 mg/kg.No data is available by inhalation. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fbb52a3-ef6f-428d-831f-1adbdc056e76/documents/IUC5-5dbb67d0-7590-4faa-8f1f-04c1406d6bb4_4148abe9-b5c9-4101-9e2a-d3e43b04dde0.html,,,,,, "(octahydro-4,7-methano-1H-indenediyl)bis(methylene) diacrylate",42594-17-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fbb52a3-ef6f-428d-831f-1adbdc056e76/documents/IUC5-5dbb67d0-7590-4faa-8f1f-04c1406d6bb4_4148abe9-b5c9-4101-9e2a-d3e43b04dde0.html,,oral,LD0,"2,000 mg/kg bw",no adverse effect observed, "(octahydro-4,7-methano-1H-indenediyl)bis(methylene) diacrylate",42594-17-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fbb52a3-ef6f-428d-831f-1adbdc056e76/documents/IUC5-5dbb67d0-7590-4faa-8f1f-04c1406d6bb4_4148abe9-b5c9-4101-9e2a-d3e43b04dde0.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, "(octahydro-4,7-methano-1H-indenediyl)bis(methylene) bismethacrylate",43048-08-4,"No repeated toxicity data is available on Tricyclodecane dimethanol dimethacrylate. However a read-across with an analogue substance is proposed for this endpoint. Under the experimental conditions of the OECD 407, following daily administration of Tricyclodecane dimethanol diacrylate for 4 weeks by oral route to male and female Sprague-Dawley rats at dose levels of 100, 300 or 1000 mg/kg/day in corn oil, the No Observed Adverse Effect Level (NOAEL) was considered to be at 1000 mg/kg/day in absence of adverse effects at this dose. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The 28-d study is considered to be reliable with a klimisch score of 1. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3cd69b65-05d2-49f0-b9b2-7f8025a02c98/documents/fb703f0e-e3f5-40b5-b5bc-38b4c502f2c8_21d7daaf-2efe-4acc-bd33-b7a36a4147c9.html,,,,,, "(octahydro-4,7-methano-1H-indenediyl)bis(methylene) bismethacrylate",43048-08-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3cd69b65-05d2-49f0-b9b2-7f8025a02c98/documents/fb703f0e-e3f5-40b5-b5bc-38b4c502f2c8_21d7daaf-2efe-4acc-bd33-b7a36a4147c9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "(octahydro-4,7-methano-1H-indenediyl)bis(methylene) bismethacrylate",43048-08-4,"An oral acute study is available on Tricyclodecane dimethacol dimethacrylate, no mortality was observed at the highest dose of 2000 mg/kg/day in rats. No acute data by dermal route is available on Tricyclodecane dimethanol dimethacrylate. However data is available on an analogue substance : Tricyclodecane dimethanol diacrylate in which no mortality was observed at the highest dose of 2000 mg/kg in rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The acute oral study is considered to be reliable. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The acute dermal study is considered to be reliable. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cd69b65-05d2-49f0-b9b2-7f8025a02c98/documents/8a38c192-0807-4d86-9351-4706c1e2ff0d_21d7daaf-2efe-4acc-bd33-b7a36a4147c9.html,,,,,, "(octahydro-4,7-methano-1H-indenediyl)bis(methylene) bismethacrylate",43048-08-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cd69b65-05d2-49f0-b9b2-7f8025a02c98/documents/8a38c192-0807-4d86-9351-4706c1e2ff0d_21d7daaf-2efe-4acc-bd33-b7a36a4147c9.html,,oral,LD0,"2,000 mg/kg bw",no adverse effect observed, "(octahydro-4,7-methano-1H-indenediyl)bis(methylene) bismethacrylate",43048-08-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cd69b65-05d2-49f0-b9b2-7f8025a02c98/documents/8a38c192-0807-4d86-9351-4706c1e2ff0d_21d7daaf-2efe-4acc-bd33-b7a36a4147c9.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, "3a,4,4a,5,8,8a,9,9a-octahydro-4,9:5,8-dimethano-1H-benz[f]indene",7158-25-0, The acute oral median lethal dose (LD50 cut- off value) TCPD (Distilled Tricyclopentadiene) in Wistar rats was found to be 5000 mg/kg body weight. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0a458bb-dcf9-4377-ae88-44887db123fd/documents/acbeb76c-98c5-4cc1-88bd-b169a016f58e_2eaa2f57-127e-4c1d-b4a5-03b16fccea36.html,,,,,, "3a,4,4a,5,8,8a,9,9a-octahydro-4,9:5,8-dimethano-1H-benz[f]indene",7158-25-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0a458bb-dcf9-4377-ae88-44887db123fd/documents/acbeb76c-98c5-4cc1-88bd-b169a016f58e_2eaa2f57-127e-4c1d-b4a5-03b16fccea36.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Tridecane,629-50-5, Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test – NOAEL ≥ 1000 mg/kg for rats (OECD 422) Repeated Dose Oral 90d - NOAEL ≥ 5000 mg/kg bw/day for rats (OECD 408) Repeated Dose Inhalation 90d – NOAEC ≥ 10400 mg/m3 for rats (similar to OECD TG 413) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0b4ddcb-41fd-4607-91bc-c936bd57aa3a/documents/7345b5c7-6a9a-4fcd-a791-24934265fcf7_a9cf0602-a2c2-4dc8-acd9-79c8e4c1a841.html,,,,,, Tridecane,629-50-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0b4ddcb-41fd-4607-91bc-c936bd57aa3a/documents/7345b5c7-6a9a-4fcd-a791-24934265fcf7_a9cf0602-a2c2-4dc8-acd9-79c8e4c1a841.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat Tridecane,629-50-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0b4ddcb-41fd-4607-91bc-c936bd57aa3a/documents/7345b5c7-6a9a-4fcd-a791-24934265fcf7_a9cf0602-a2c2-4dc8-acd9-79c8e4c1a841.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"10,400 mg/m3",,rat Tridecane,629-50-5, Acute Toxicity-Oral LD50 > 5000 mg/kg in rats (OECD TG 401) Acute Toxicity-Inhalation LC50 > 6100 mg/m3 (OECD TG 403) Acute Toxicity-Dermal LD50 > 3160 mg/kg in rabbits (OECD TG 402) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0b4ddcb-41fd-4607-91bc-c936bd57aa3a/documents/193d2f6d-2ffe-4ead-a616-6d5e89699d79_a9cf0602-a2c2-4dc8-acd9-79c8e4c1a841.html,,,,,, Tridecane,629-50-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0b4ddcb-41fd-4607-91bc-c936bd57aa3a/documents/193d2f6d-2ffe-4ead-a616-6d5e89699d79_a9cf0602-a2c2-4dc8-acd9-79c8e4c1a841.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Tridecane,629-50-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0b4ddcb-41fd-4607-91bc-c936bd57aa3a/documents/193d2f6d-2ffe-4ead-a616-6d5e89699d79_a9cf0602-a2c2-4dc8-acd9-79c8e4c1a841.html,,dermal,LD50,"3,160 mg/kg bw",no adverse effect observed, Tridecane,629-50-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0b4ddcb-41fd-4607-91bc-c936bd57aa3a/documents/193d2f6d-2ffe-4ead-a616-6d5e89699d79_a9cf0602-a2c2-4dc8-acd9-79c8e4c1a841.html,,inhalation,LC50,"6,100 mg/m3",no adverse effect observed, "Isotridecanol, ethoxylated",69011-36-5," Oral (subchronic, rat, OECD 408): NOAEL (systemic toxicity) = 500 mg/kg bw/day Conclusion based on data obtained with isotridecanol, ethoxylated, < 2.5 EO (CAS No. 69011-36-5, EC No. 500-241-6). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c04c5dc3-583b-44d1-ba35-6872a78da25d/documents/7304d1c2-2b71-4523-af19-67119ecd661f_a18319e3-6667-4524-ba48-27da2c79cb70.html,,,,,, "Isotridecanol, ethoxylated",69011-36-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c04c5dc3-583b-44d1-ba35-6872a78da25d/documents/7304d1c2-2b71-4523-af19-67119ecd661f_a18319e3-6667-4524-ba48-27da2c79cb70.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Isotridecanol, ethoxylated",69011-36-5," Oral (rat): LD50 > 2000 mg/kg bw Read-across (Weight-of-Evidence approach) based on the analogue source substances isotridecanol, ethoxylated, 3 EO (CAS No. 69011-36-5), isotridecanol, ethoxylated, 3-4 EO (CAS No. 69011-36-5) and 11-methyldodecan-1-ol (isotridecanol, CAS No. 27458-92-0, EC No. 248-469-2). Inhalation: No study required as the inhalation route of exposure is considered less relevant than the dermal route for isotridecanol, ethoxylated, < 2.5 EO (CAS No. 69011-36-5, EC No. 500-241-6). Dermal: LD50 > 2000 mg/kg bw Read-across (Weight-of-Evidence approach) based on the analogue source substances alcohols, C12-13, ethoxylated, < 2.5 EO (CAS No. 66455-14-9, EC No. 500-165-3) and 11-methyldodecan-1-ol (isotridecanol, CAS No. 27458-92-0, EC No. 248-469-2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c04c5dc3-583b-44d1-ba35-6872a78da25d/documents/48e32b21-c4e6-41af-936d-2937d76a5d42_a18319e3-6667-4524-ba48-27da2c79cb70.html,,,,,, "Isotridecanol, ethoxylated",69011-36-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c04c5dc3-583b-44d1-ba35-6872a78da25d/documents/48e32b21-c4e6-41af-936d-2937d76a5d42_a18319e3-6667-4524-ba48-27da2c79cb70.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Isotridecanol, ethoxylated",69011-36-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c04c5dc3-583b-44d1-ba35-6872a78da25d/documents/48e32b21-c4e6-41af-936d-2937d76a5d42_a18319e3-6667-4524-ba48-27da2c79cb70.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Tridecan-1-ol,112-70-9," Repeated dose toxicity: via oral route The test chemical was administered daily to groups of rats at levels up to 1000 mg/kg for 26 weeks. Body weight and food consumption was not affected by treatment. Haematology, clinical chemistry and gross necropsy investigations showed no evidence of toxicity. There were no treatment related microscopic changes. Repeated inhalation study: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the test chemical, which is reported as 0.0099 kPa at temperature 101 Deg C & 101.324 kPa at temperature 280.45 Deg C. Also considering the particle size distribution of the substance the majority of the particles was found to be in the size of 150 micron to 53micron which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. Repeated dermal study: The acute toxicity value for the given test chemical (as provided in section 7.2.3) is >2600 mg/kg body weight. The OECD study result for acute toxicity by the dermal indicates the LD50 value to be greater than 2000 mg/kg body weight. In addition, the skin sensitization also indicates negative skin sensitization potential by the chemical. Also considering the use of the chemical as a fragrance chemical and considering the volatility absorption by the dermal route is not considered to be significant. Thus, given the above considerations, it is assumed that Tridecanol shall not exhibit repeated dose toxicity by the dermal route.. Therefore this study is considered for waiver.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/afd8b0de-8c3c-4830-b669-991786d16e85/documents/e560580f-a9f9-448f-a061-b4232d16baea_98c6fd2c-93f7-45ef-8c37-8a06409afa66.html,,,,,, Tridecan-1-ol,112-70-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/afd8b0de-8c3c-4830-b669-991786d16e85/documents/e560580f-a9f9-448f-a061-b4232d16baea_98c6fd2c-93f7-45ef-8c37-8a06409afa66.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tridecan-1-ol,112-70-9," Acute oral toxicity:  An acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is >4750 mg/kg bw. The study concluded that the LD50 is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  An acute Inhalation toxicity dose (LC50) was considered based on different studies conducted on rats, mice and guinea pigs for the test chemical. The LC50 value is >12 ppm (>12000 mg/m3). The study concluded that the LC50 value is >5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute Inhalation toxicity. Acute Dermal toxicity:  An acute Dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The LD50 value is >2600 mg/kg bw. The study concluded that the LD50 is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/afd8b0de-8c3c-4830-b669-991786d16e85/documents/78ec210f-b3d2-4042-b116-cf78a5af127d_98c6fd2c-93f7-45ef-8c37-8a06409afa66.html,,,,,, Tridecan-1-ol,112-70-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/afd8b0de-8c3c-4830-b669-991786d16e85/documents/78ec210f-b3d2-4042-b116-cf78a5af127d_98c6fd2c-93f7-45ef-8c37-8a06409afa66.html,,oral,LD50,"4,750 mg/kg bw",no adverse effect observed, Tridecan-1-ol,112-70-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/afd8b0de-8c3c-4830-b669-991786d16e85/documents/78ec210f-b3d2-4042-b116-cf78a5af127d_98c6fd2c-93f7-45ef-8c37-8a06409afa66.html,,dermal,LD50,"2,600 mg/kg bw",no adverse effect observed, Tridecan-1-ol,112-70-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/afd8b0de-8c3c-4830-b669-991786d16e85/documents/78ec210f-b3d2-4042-b116-cf78a5af127d_98c6fd2c-93f7-45ef-8c37-8a06409afa66.html,,inhalation,LC50,"12,000 mg/m3",no adverse effect observed, Triethoxyoctylsilane,2943-75-1,"In the key 90-day oral repeated dose toxicity study with the registered substance triethoxy(octyl)silane (CAS 2943-75-1, EC 220-941-2), conducted according to OECD Test Guideline 408 and in compliance with GLP (BSL BIOSERVICE, 2021), the NOAEL for systemic effects was concluded to be 250 mg/kg bw/day based on minimal adverse effects in peripheral nerves and spinal cord at 400 mg/kg bw/day. The study was conducted according to an appropriate OECD test guideline and in compliance with GLP. In an oral combined repeated dose toxicity study with the reproduction / developmental toxicity screening test conducted according to OECD 422 and in compliance with GLP (reliability score 1) the NOAEL for triethoxyoctylsilane for general systemic toxicity was 300 mg/kg bw/day, based on bladder epithelial hyperplasia in males and the neuromuscular findings in the toxicity and reproductive phase females at 1000 mg/kg bw/day (Dow corning Corporation, 2010, reliability score 1). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b1f548a-d58e-4b40-ab20-3b4f256ec43a/documents/5209cf5d-4cdc-4337-861b-2914f92f22f9_c96bde44-3ba6-438b-8130-6cb28738f434.html,,,,,, Triethoxyoctylsilane,2943-75-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b1f548a-d58e-4b40-ab20-3b4f256ec43a/documents/5209cf5d-4cdc-4337-861b-2914f92f22f9_c96bde44-3ba6-438b-8130-6cb28738f434.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Triethoxyoctylsilane,2943-75-1,"In an acute oral toxicity study of triethoxy(octyl)silane (CAS 2943-75-1, EC 220-941-2) conducted to the now deleted OECD Test Guideline 401 and in compliance with GLP (ASTA Medica AG, 1992a), the LD50 for triethoxy(octyl)silane was at least 5110 mg/kg bw in rats. Signs of intoxication were slight to moderate hypokinesia, diarrhoea and piloerection in male and female rats. In addition, individual female animals showed coordination disturbances, stilted gait, red encrusted snout, strenuous respiration, sunken sides and vocalisation on handling. In general symptoms were observed on days two to three. In one female, first symptoms appeared 160 minutes after administration. In individual females, signs of toxicity lasted for 14 days or until death. In male animals, symptoms lasted at most for three days. There were body weight reductions in males and females. At necropsy no abnormalities were detected. Only in the deceased female rat the gastro-intestinal tract was severely autolytic.     In an acute dermal toxicity study conducted using a protocol comparable to OECD Test Guideline 402, and in compliance with GLP (BRRC, 1992) the LD50 for male rabbits was 6730 mg/kg bw, and for females was at least 8000 mg/kg bw. Dermal reactions included erythema, oedema, necrosis, fissuring, desquamation and alopecia (signs of skin irritation at all doses in both sexes). Signs of toxicity included sluggishness, an unsteady gait, laboured breathing, forelimb paralysis (one male that died), hindlimb paresis (reversible weakness to temporary loss of ability to stand), nephritis, slight wetness of the perinasal fur, head with swaying motion. Recovery of survivors was 2-14 days. There were no treatment-related microscopic findings.     In an acute inhalation study conducted using a protocol that was similar to OECD Test Guideline 403, and in compliance with GLP (WIL Research Laboratories, 2000) the LC50 was at least 22 ppm, approximately 0.25 mg/l (the highest dose tested) in rats. There were no deaths and no significant clinical effects, effects on bodyweight or gross necropsy findings. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b1f548a-d58e-4b40-ab20-3b4f256ec43a/documents/a57d511a-b348-4fda-92bb-e477438bc94f_c96bde44-3ba6-438b-8130-6cb28738f434.html,,,,,, Triethoxyoctylsilane,2943-75-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b1f548a-d58e-4b40-ab20-3b4f256ec43a/documents/a57d511a-b348-4fda-92bb-e477438bc94f_c96bde44-3ba6-438b-8130-6cb28738f434.html,,oral,LD50,"5,110 mg/kg bw",adverse effect observed, Triethoxyoctylsilane,2943-75-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b1f548a-d58e-4b40-ab20-3b4f256ec43a/documents/a57d511a-b348-4fda-92bb-e477438bc94f_c96bde44-3ba6-438b-8130-6cb28738f434.html,,dermal,LD50,"6,730 mg/kg bw",adverse effect observed, Triethoxyoctylsilane,2943-75-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b1f548a-d58e-4b40-ab20-3b4f256ec43a/documents/a57d511a-b348-4fda-92bb-e477438bc94f_c96bde44-3ba6-438b-8130-6cb28738f434.html,,inhalation,LC50,250 mg/m3,no adverse effect observed, Triethyl citrate,77-93-0,"Based on all pieces of weight of evidence it is clear that triethyl citrate is of very low toxicity after repeated administrations.Oral route:1) RTECS: TDLo (cat) of 15904 mg/kg/8 weeks was determined for the substance of interest TEC.2) A GLP test equivalent to OECD 408 resulted in a NOAEL (rat) of 1000 mg/kg bw . [Read-across data from tributyl-O-acetylcitrate (CAS 77-90-7)]3) TNO BIBRA, 1998: 15 m/15 f rats were fed up to 3% triethyl citrate in a diet (about 1.5 g/kg bw/day) for 2 years. Reduced feed intake and growth when level of compound in diet was increased, upper limit not specified (LaWall & Harrison, 1954).4)TNO BIBRA, 1998: Normal growth and blood characteristics in groups of about 7 rats fed up to 4 g/kg bw in a diet for 6 weeks, no cellular changes in the major tissues. Growth was slightly slower in immature rats fed with 10 g/kg bw/day for 6 weeks, probably due to an increased frequency of diarrhoea (Finkelstein & Gold, 1959). 5) TNO BIBRA, 1998: Normal growth, ECG and various blood parameters in 6 cats fed 0.28 g/kg bw/day by stomach tube for 8 weeks. Weakness, incoordination and CNS depression were seen; no gross abnormalities. 3 cats given 2.3 g/kg bw/day by stomach tube died within a few days and three others given 1.1 g/kg bw every 4h died after 8-10 doses (Finkelstein & Gold, 1959).6) TNO BIBRA, 1998: No effects on growth or cellular changes in the tissues were seen in 4 dogs given up to about 0.25 g/kg bw/day (presumably by stomach tube) for 6 months. Urine and blood samples were also normal. A dog given (by stomach tube) 2.3 g/kg bw/day for an unspecified time followed by 1.7 g/kg bw for 1 month demonstrated undisclosed clinical toxicity but no liver lesions. Liver damages were seen in three dogs given 2.8-4.0 g/kg bw/day by stomach tube for 7-12 weeks (Hodge, 1954). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9611f0e-b817-4d3b-9803-2efe76dd65ce/documents/IUC5-ed6d4238-e085-4ecd-8ba0-c5ffbd107d54_5fb6e84a-eae0-47ac-8258-e17b878b5376.html,,,,,, Triethyl citrate,77-93-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9611f0e-b817-4d3b-9803-2efe76dd65ce/documents/IUC5-ed6d4238-e085-4ecd-8ba0-c5ffbd107d54_5fb6e84a-eae0-47ac-8258-e17b878b5376.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Triethyl citrate,77-93-0,"Triethyl citrate is of very low acute toxicity if administered to animals via all exposure routes. The substance therefore does need to be classified for acute toxicity.Acute toxicity: oral1) RTECS: LD50 (rat) = 5900 mg/kg bw2) Finkelstein (1959): LD50 (rat) = ca. 7 mL/kg bw3) Finkelstein (1959): LD50 (cat) = ca. 3.5 mL/kg bw4) BIBRA (1998): LD50 (rat) >3.2 g/kg bw5) BIBRA (1998): LD50 (guinea pig) > 25mL/kg bwAcute toxicity: inhalation1) RTECS: LC50 (rat) = 1300 ppm/6h (= 14927.34 mg/m3)2) BIBRA (1998): LC50 (6 hours, rat) = 1300-3500 ppm (= 14927- 40189 mg/m3)3) BIBRA (1998): A group of six guinea-pigs survived a 6 hour exposure to 1700 ppm (= 19520.37 mg/m3) vapour.Acute toxicity: dermal1) RTECS: LD50 (rabbit) >5000 mg/kg2) BIBRA (1998): LD50 (rabbit) >5 g/kg bw3) BIBRA (1998): LD50 (guinea-pig) >11.4 g/kg bw4) Patty (1982): LD50 (Guinea-Pig) > 10 mL/kg ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9611f0e-b817-4d3b-9803-2efe76dd65ce/documents/IUC5-69577e0b-15e3-4c1b-adbe-fcf674d9913d_5fb6e84a-eae0-47ac-8258-e17b878b5376.html,,,,,, Triethyl citrate,77-93-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9611f0e-b817-4d3b-9803-2efe76dd65ce/documents/IUC5-69577e0b-15e3-4c1b-adbe-fcf674d9913d_5fb6e84a-eae0-47ac-8258-e17b878b5376.html,,oral,LD50,"3,200 mg/kg bw",no adverse effect observed, Triethyl citrate,77-93-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9611f0e-b817-4d3b-9803-2efe76dd65ce/documents/IUC5-69577e0b-15e3-4c1b-adbe-fcf674d9913d_5fb6e84a-eae0-47ac-8258-e17b878b5376.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Triethyl citrate,77-93-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9611f0e-b817-4d3b-9803-2efe76dd65ce/documents/IUC5-69577e0b-15e3-4c1b-adbe-fcf674d9913d_5fb6e84a-eae0-47ac-8258-e17b878b5376.html,,inhalation,LC50,"14,927.34 mg/m3",no adverse effect observed, Triethyl phosphate,78-40-0,"NOAEL = 200 mg/kg bw/day – 90-day subchronic study – gavage – Beerens-Heijnen (2017) - OECD 408 / GLP / Key, rel.1. NOAEL = 1000 mg/kg bw/day – 28 day subacute study – gavage – Leser (1992) - EU B.7, GLP, Sup., rel.1. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/286c1ba6-5df9-4c9e-9e12-423d61d84f4d/documents/IUC5-2f10b2a2-49eb-4202-803e-ef0f80429ac7_cab1e4df-09ae-40b4-a0c7-f5da4cfdb092.html,,,,,, Triethyl phosphate,78-40-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/286c1ba6-5df9-4c9e-9e12-423d61d84f4d/documents/IUC5-2f10b2a2-49eb-4202-803e-ef0f80429ac7_cab1e4df-09ae-40b4-a0c7-f5da4cfdb092.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat Triethyl phosphate,78-40-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/286c1ba6-5df9-4c9e-9e12-423d61d84f4d/documents/IUC5-2f10b2a2-49eb-4202-803e-ef0f80429ac7_cab1e4df-09ae-40b4-a0c7-f5da4cfdb092.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Triethyl phosphate,78-40-0,"Acute toxicity - oral: LD50(rat) > 800 mg/kg bw (no data, WOE, rel.4) LD50(mouse) = 1500 mg/kg bw (no data, WOE, rel.4) LD50(rat/mouse/guinea pig) = 1600 (non-GLP, WOE, rel.4) LD50(mouse) = 1370 mg/kg bw (non-GLP, WOE, rel.4)   Acute toxicity - inhalation: LC50 > 8817 mg/m3 (OECD 403, GLP, Key, rel.1)   Acute toxicity - dermal: data waiving ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/286c1ba6-5df9-4c9e-9e12-423d61d84f4d/documents/IUC5-a07e24e8-3917-4a4c-8c3d-7749348459c7_cab1e4df-09ae-40b4-a0c7-f5da4cfdb092.html,,,,,, Triethyl phosphate,78-40-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/286c1ba6-5df9-4c9e-9e12-423d61d84f4d/documents/IUC5-a07e24e8-3917-4a4c-8c3d-7749348459c7_cab1e4df-09ae-40b4-a0c7-f5da4cfdb092.html,,oral,LD50,"1,600 mg/kg bw",adverse effect observed, Triethyl phosphate,78-40-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/286c1ba6-5df9-4c9e-9e12-423d61d84f4d/documents/IUC5-a07e24e8-3917-4a4c-8c3d-7749348459c7_cab1e4df-09ae-40b4-a0c7-f5da4cfdb092.html,,inhalation,LC50,"8,817 mg/m3",adverse effect observed, Triethylamine,121-44-8,"Lynch et al. (1990): Subchronic Inhalation of Triethylamine Vapor in Fischer-344 Rats: Organ System Toxicity. Method comparable to Guideline. Rats, exposed to 0, 25 and 247 ppm for 28 weeks.   Combined 90-Day Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test of Triethylamine by Oral Gavage in Rats, including a Tolerability Study for Dosing F1-Animals. OECD Guideline 422, daily exposure by oral gavage at doses of 70, 200, and 550mg/kg bw for >90 days. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ccf492b-5ae7-40a5-9e48-80985f0600fa/documents/IUC5-ee19c337-8621-4c79-845c-10cee2efe73f_4e7d3044-e2f2-448f-8552-258a8f2943fa.html,,,,,, Triethylamine,121-44-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ccf492b-5ae7-40a5-9e48-80985f0600fa/documents/IUC5-ee19c337-8621-4c79-845c-10cee2efe73f_4e7d3044-e2f2-448f-8552-258a8f2943fa.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Triethylamine,121-44-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ccf492b-5ae7-40a5-9e48-80985f0600fa/documents/IUC5-ee19c337-8621-4c79-845c-10cee2efe73f_4e7d3044-e2f2-448f-8552-258a8f2943fa.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,020 mg/m3",,rat Triethylamine,121-44-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ccf492b-5ae7-40a5-9e48-80985f0600fa/documents/IUC5-ee19c337-8621-4c79-845c-10cee2efe73f_4e7d3044-e2f2-448f-8552-258a8f2943fa.html,Repeated dose toxicity – local effects,inhalation,NOAEC,103.3 mg/m3,,rat Triethylamine,121-44-8,"Acute oral toxicity: Myers and Ballantyne (1997) comparable to the OECD Guideline 401, rats (m/f),doses: 182, 365, and 730 mg/kg bw mg/kg bw, LD50 < 182 mg/kg bw. Acute dermal toxicity: Meyers and Ballantyne, 1997. Comparative acute and primary irritancy of various classes of amines, comparable to the OECD guideline 402; New Zealand Black rabbits, doses 0.5, 1.0 and 2.0 mL/kg bw, LD50 580 mg/kg bw. Acute inhalation toxicity: ""Triethylamine: Acute Inhalation (1-Hr. LC50) Study in Rats"", International Research and Development Corporation, study report 214-060, 1995. According to the OECD Guideline 403. Actual concentrations: 2,450, 3,200, 4,000, and 5,050 ppm, LC50 1748 ppm = 7298 mg/m³ ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ccf492b-5ae7-40a5-9e48-80985f0600fa/documents/IUC5-23026c15-4856-4efc-a1d5-cb282ad58014_4e7d3044-e2f2-448f-8552-258a8f2943fa.html,,,,,, Triethylamine,121-44-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ccf492b-5ae7-40a5-9e48-80985f0600fa/documents/IUC5-23026c15-4856-4efc-a1d5-cb282ad58014_4e7d3044-e2f2-448f-8552-258a8f2943fa.html,,oral,LD50,< 182 mg/kg bw,adverse effect observed, Triethylamine,121-44-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ccf492b-5ae7-40a5-9e48-80985f0600fa/documents/IUC5-23026c15-4856-4efc-a1d5-cb282ad58014_4e7d3044-e2f2-448f-8552-258a8f2943fa.html,,dermal,LD50,580 mg/kg bw,adverse effect observed, Triethylamine,121-44-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ccf492b-5ae7-40a5-9e48-80985f0600fa/documents/IUC5-23026c15-4856-4efc-a1d5-cb282ad58014_4e7d3044-e2f2-448f-8552-258a8f2943fa.html,,inhalation,LC50,7.2 mg/L,adverse effect observed, "2,2'-(ethylenedioxy)diethanol",112-27-6, The NOAEL for repeated oral toxicity was determined to be 1522 mg/kg bw/day in rats. The NOAEC for repeated inhalation toxicity was determined to be 750.865 mg/m3 in rats ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a65522b-b7d7-406e-8c93-48fbc4d921bc/documents/db8c41ac-bdb6-46df-a34a-09b96b43e7b3_31d95d2f-3130-45cd-9ee9-14432119c117.html,,,,,, "2,2'-(ethylenedioxy)diethanol",112-27-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a65522b-b7d7-406e-8c93-48fbc4d921bc/documents/db8c41ac-bdb6-46df-a34a-09b96b43e7b3_31d95d2f-3130-45cd-9ee9-14432119c117.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,522 mg/kg bw/day",,rat "2,2'-(ethylenedioxy)diethanol",112-27-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a65522b-b7d7-406e-8c93-48fbc4d921bc/documents/db8c41ac-bdb6-46df-a34a-09b96b43e7b3_31d95d2f-3130-45cd-9ee9-14432119c117.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,750.865 mg/m3,,rat "2,2'-(ethylenedioxy)diethanol",112-27-6, An oral LD50 was determined to be > 16 mL/kg bw (18080 mg/kg bw). The dermal LD50 for rabbits was determined to be > 16 mL/kg bw (18080 mg/kg bw). The inhalation LC50 for rats was determined to be > 5.2 mg/L. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a65522b-b7d7-406e-8c93-48fbc4d921bc/documents/3bf9763a-733e-414e-a1ab-9b3d8bf59791_31d95d2f-3130-45cd-9ee9-14432119c117.html,,,,,, "2,2'-(ethylenedioxy)diethanol",112-27-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a65522b-b7d7-406e-8c93-48fbc4d921bc/documents/3bf9763a-733e-414e-a1ab-9b3d8bf59791_31d95d2f-3130-45cd-9ee9-14432119c117.html,,oral,discriminating dose,"18,080 mg/kg bw",no adverse effect observed, "2,2'-(ethylenedioxy)diethanol",112-27-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a65522b-b7d7-406e-8c93-48fbc4d921bc/documents/3bf9763a-733e-414e-a1ab-9b3d8bf59791_31d95d2f-3130-45cd-9ee9-14432119c117.html,,dermal,discriminating dose,"18,080 mg/kg bw",no adverse effect observed, "2,2'-(ethylenedioxy)diethanol",112-27-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a65522b-b7d7-406e-8c93-48fbc4d921bc/documents/3bf9763a-733e-414e-a1ab-9b3d8bf59791_31d95d2f-3130-45cd-9ee9-14432119c117.html,,inhalation,discriminating conc.,"5,200 mg/m3",no adverse effect observed, "2,2'-ethylenedioxydiethyl dimethacrylate",109-16-0," Subacute (33-40 day) study; oral (gavage); rat, OECD 422, GLP: NOAEL = 1000 mg/kg bw/d Subacute (14 day), subchronic (90 day) and chronic (78 weeks) studies; dermal; mouse, m (no specific guideline, GLP): no systemic toxicity, local irritation at the site of application Data from the metabolites after rapid hydrolysis TREG: Subchronic (90d) study, oral, feeding, rat, OECD 408, GLP: NOAEL 1522 mg/kg bw/d males & 1622 mg/kg bw/d females MAA: Subchronic (90d) study, inhalation, rat, OECD 408, GLP: NOAEC local & systemic 100 ppm = 352 mg/m3 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/195e863d-13ea-46c8-8667-ac902a19e709/documents/5e1d72a2-9371-4df9-99a3-71cb01fdaa1e_873d570c-8bc4-490c-a07f-9b743d1ca021.html,,,,,, "2,2'-ethylenedioxydiethyl dimethacrylate",109-16-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/195e863d-13ea-46c8-8667-ac902a19e709/documents/5e1d72a2-9371-4df9-99a3-71cb01fdaa1e_873d570c-8bc4-490c-a07f-9b743d1ca021.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2'-ethylenedioxydiethyl dimethacrylate",109-16-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/195e863d-13ea-46c8-8667-ac902a19e709/documents/5e1d72a2-9371-4df9-99a3-71cb01fdaa1e_873d570c-8bc4-490c-a07f-9b743d1ca021.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,mouse "2,2'-ethylenedioxydiethyl dimethacrylate",109-16-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/195e863d-13ea-46c8-8667-ac902a19e709/documents/5e1d72a2-9371-4df9-99a3-71cb01fdaa1e_873d570c-8bc4-490c-a07f-9b743d1ca021.html,Repeated dose toxicity – local effects,dermal,NOAEL,100 ,adverse effect observed,mouse "2,2'-ethylenedioxydiethyl dimethacrylate",109-16-0,"Acute oral toxicity: LD50 (rat) >2000 mg/kg bw OECD Guideline 420, GLP study; LD50 (mouse) = 10750 mg/kg bw; no information on test procedure; no GLPAcute inhalation toxicity: no relevant route of exposureAcute dermal toxicity: LD50 (mouse) > 2000 mg/kg bw; 14 d-dose ranged finding study, GLP ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/195e863d-13ea-46c8-8667-ac902a19e709/documents/51b86784-8c3b-43b9-86cc-a09bf9f8ef3e_873d570c-8bc4-490c-a07f-9b743d1ca021.html,,,,,, "2,2'-ethylenedioxydiethyl dimethacrylate",109-16-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/195e863d-13ea-46c8-8667-ac902a19e709/documents/51b86784-8c3b-43b9-86cc-a09bf9f8ef3e_873d570c-8bc4-490c-a07f-9b743d1ca021.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,2'-ethylenedioxydiethyl dimethacrylate",109-16-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/195e863d-13ea-46c8-8667-ac902a19e709/documents/51b86784-8c3b-43b9-86cc-a09bf9f8ef3e_873d570c-8bc4-490c-a07f-9b743d1ca021.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, hydrogenated, esters with triethylene glycol",68648-53-3," Information is available on the oral repeated dose toxicity of Rosin esters (simple, linear, and bulky). No treatment-related or biologically relevant findings were apparent in rats following oral sub-chronic dietary exposure to Resin acids and rosin acids, esters with glycerol, Resin acids and rosin acids, esters with ethylene glycol, Resin acids and rosin acids, esters with triethylene glycol, Resin acids and rosin acids, hydrogenated, esters with glycerol and Resin acids and rosin acids, hydrogenated, esters with pentaerythritol. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3bd4f6e6-7664-4ed4-97a3-ae7852a61126/documents/32e577c3-3b3e-4c35-aea5-cf72d6c6374d_43149bd8-8275-43c6-bfa5-ef099fff9daa.html,,,,,, "Resin acids and Rosin acids, hydrogenated, esters with triethylene glycol",68648-53-3,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bd4f6e6-7664-4ed4-97a3-ae7852a61126/documents/67fc8f5b-82b2-4593-b8f5-ab3cbc75cd32_43149bd8-8275-43c6-bfa5-ef099fff9daa.html,,,,,, "Resin acids and Rosin acids, hydrogenated, esters with triethylene glycol",68648-53-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bd4f6e6-7664-4ed4-97a3-ae7852a61126/documents/67fc8f5b-82b2-4593-b8f5-ab3cbc75cd32_43149bd8-8275-43c6-bfa5-ef099fff9daa.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, hydrogenated, esters with triethylene glycol",68648-53-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bd4f6e6-7664-4ed4-97a3-ae7852a61126/documents/67fc8f5b-82b2-4593-b8f5-ab3cbc75cd32_43149bd8-8275-43c6-bfa5-ef099fff9daa.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Propane-1,2,3-triyl 2-ethylhexanoate",7360-38-5," Short-term (28-day) repeated dose toxicity: oral (OECD 407): NOAEL (rat, m/f) ≥ 1000 mg/kg bw/day (highest dose tested) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1437941-8e4b-47f6-84eb-fa61e2f9a748/documents/6d7a4766-9321-40e2-88ab-8260f09faa6d_2152512b-6995-4623-bf95-82394cafa08d.html,,,,,, "Propane-1,2,3-triyl 2-ethylhexanoate",7360-38-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1437941-8e4b-47f6-84eb-fa61e2f9a748/documents/6d7a4766-9321-40e2-88ab-8260f09faa6d_2152512b-6995-4623-bf95-82394cafa08d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Propane-1,2,3-triyl 2-ethylhexanoate",7360-38-5," Oral (OECD 401), rat LD50 > 5 mL/kg bw, corresponding to 4820 mg/kg bw Read-across from structural analogue source substance propane-1,2,3-triyl triheptanoate (CAS 620-67-7).   Inhalation (OECD 403), rat LC50 > 1.86 mg/L air Read-across from structural analogue source substance glycerides, mixed decanoyl and octanoyl (CAS 73398-61-5).   Dermal (OECD 402), rat LD50 > 2000 mg/kg bw Read-across from structural analogue source substance propane-1,2,3-triyl triheptanoate (CAS 620-67-7). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1437941-8e4b-47f6-84eb-fa61e2f9a748/documents/9c75a866-96bf-4481-8153-d91571a8a304_2152512b-6995-4623-bf95-82394cafa08d.html,,,,,, "Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate",3319-31-1,90-day sub-chronic toxicity: NOAEL 225 mg/kg/day ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3ef5605-670e-4599-9f06-72750d213cdf/documents/IUC5-ce134f73-6754-4576-8eec-669b541eedb7_278fbb27-ca43-4cc5-83dc-5743748ea8e5.html,,,,,, "Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate",3319-31-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3ef5605-670e-4599-9f06-72750d213cdf/documents/IUC5-ce134f73-6754-4576-8eec-669b541eedb7_278fbb27-ca43-4cc5-83dc-5743748ea8e5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,225 mg/kg bw/day,,rat "Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate",3319-31-1,- Acute toxicity:Oral: LD50: >2000 mg/kg in the ratInhalation (4 hours) LD50: > 2600 mg / m3 in the rat Dermal: LD50: > 2000 mg/kg in the rabbit ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3ef5605-670e-4599-9f06-72750d213cdf/documents/IUC5-28f7626a-e15f-4131-96c1-32a599c3030e_278fbb27-ca43-4cc5-83dc-5743748ea8e5.html,,,,,, "Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate",3319-31-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3ef5605-670e-4599-9f06-72750d213cdf/documents/IUC5-28f7626a-e15f-4131-96c1-32a599c3030e_278fbb27-ca43-4cc5-83dc-5743748ea8e5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate",3319-31-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3ef5605-670e-4599-9f06-72750d213cdf/documents/IUC5-28f7626a-e15f-4131-96c1-32a599c3030e_278fbb27-ca43-4cc5-83dc-5743748ea8e5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tris(2-ethylhexyl) benzene-1,2,4-tricarboxylate",3319-31-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3ef5605-670e-4599-9f06-72750d213cdf/documents/IUC5-28f7626a-e15f-4131-96c1-32a599c3030e_278fbb27-ca43-4cc5-83dc-5743748ea8e5.html,,inhalation,LC50,"2,600 mg/m3",no adverse effect observed, "2,2,2-trifluoroethyl methacrylate",352-87-4,Acute oral toxicity: Oral LD50 (rat) = ca 200 mg/kg bw; OECD Guideline 401 studies; GLP compliantAcute inhalative toxicity:4 h LC50 (rat) = ca. 2.7 mg/L; OECD Guideline 403 studies; GLP compliantAcute dermal toxicity:Dermal LD50 (rat) > 2000 mg/kg bw; OECD guideline 402 studies; GLP compliant ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69acdef3-d879-4c88-8aa9-87be307ff881/documents/IUC5-e4523854-4181-47cd-ab1b-05fdb443b5e1_49e316e7-549c-492f-be99-13c575720709.html,,,,,, "2,2,2-trifluoroethyl methacrylate",352-87-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69acdef3-d879-4c88-8aa9-87be307ff881/documents/IUC5-e4523854-4181-47cd-ab1b-05fdb443b5e1_49e316e7-549c-492f-be99-13c575720709.html,,oral,LD50,200 mg/kg bw,adverse effect observed, "2,2,2-trifluoroethyl methacrylate",352-87-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69acdef3-d879-4c88-8aa9-87be307ff881/documents/IUC5-e4523854-4181-47cd-ab1b-05fdb443b5e1_49e316e7-549c-492f-be99-13c575720709.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2,2-trifluoroethyl methacrylate",352-87-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69acdef3-d879-4c88-8aa9-87be307ff881/documents/IUC5-e4523854-4181-47cd-ab1b-05fdb443b5e1_49e316e7-549c-492f-be99-13c575720709.html,,inhalation,LC50,"2,700 mg/m3",adverse effect observed, "2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane",2374-14-3," In the key oral 90-day repeated dose toxicity study (Dow Corning Corporation, 2002) conducted according to EPA OPPTS 870.3100 (90-Day Oral Toxicity in Rodents) and in compliance with GLP, the systemic NOAEL for 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane was concluded to be 0.8 mg/kg bw/day based on mortality at 20 or 50/35 mg/kg bw/day, clinical signs, body weight, food consumption, clinical chemistry, functional observation battery effects and organ weight effects at 20 and/or 50/35 mg/kg bw/day and pathology findings in the skeletal muscle at 20 and 50/35 mg/kg/day groups and heart at 4, 20 or 50/35 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f31e137-4ba3-4cb9-a78e-85486e669ee5/documents/8826257e-111a-4ad2-bcea-d1693bcc1411_fb46fb80-bd02-4f3c-af94-6147ea9972ab.html,,,,,, "2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane",2374-14-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f31e137-4ba3-4cb9-a78e-85486e669ee5/documents/8826257e-111a-4ad2-bcea-d1693bcc1411_fb46fb80-bd02-4f3c-af94-6147ea9972ab.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,40 mg/kg bw/day,,rabbit "2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane",2374-14-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f31e137-4ba3-4cb9-a78e-85486e669ee5/documents/8826257e-111a-4ad2-bcea-d1693bcc1411_fb46fb80-bd02-4f3c-af94-6147ea9972ab.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.8 mg/kg bw/day,,rat "2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane",2374-14-3," The key acute oral toxicity study for 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane reports an LD50 value of 4659 mg/kg bw in a reliable study conducted according to the now-deleted OECD Test Guideline 401 and in compliance with GLP (TNO, 1986). The key acute dermal toxicity study for 2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane reports an LD50 value of >20000 mg/kg bw in a reliable study conducted according to a guideline similar to OECD Test Guideline 402 and in compliance with GLP (Cannon Laboratories, 1979). In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5.2) does not need to be conducted as reliable data via the oral and dermal routes are available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f31e137-4ba3-4cb9-a78e-85486e669ee5/documents/ed93acc5-d88f-4e62-8d58-d27e16668f04_fb46fb80-bd02-4f3c-af94-6147ea9972ab.html,,,,,, "2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane",2374-14-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f31e137-4ba3-4cb9-a78e-85486e669ee5/documents/ed93acc5-d88f-4e62-8d58-d27e16668f04_fb46fb80-bd02-4f3c-af94-6147ea9972ab.html,,oral,LD50,"4,659 mg/kg bw",no adverse effect observed, "2,4,6-trimethyl-2,4,6-tris(3,3,3-trifluoropropyl)cyclotrisiloxane",2374-14-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f31e137-4ba3-4cb9-a78e-85486e669ee5/documents/ed93acc5-d88f-4e62-8d58-d27e16668f04_fb46fb80-bd02-4f3c-af94-6147ea9972ab.html,,dermal,LD50,"20,000 mg/kg bw",adverse effect observed, "Fenugreek, ext.",84625-40-1," In one acute oral study (K2), the oral LD50 was found to be superior to 5 g/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e119720-cea6-4435-9e8b-dcd44baf3658/documents/ca326280-209a-45ee-b033-7d7a4e4c8160_5957e9ca-4cf4-4440-8a9c-99de834cea37.html,,,,,, "Fenugreek, ext.",84625-40-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e119720-cea6-4435-9e8b-dcd44baf3658/documents/ca326280-209a-45ee-b033-7d7a4e4c8160_5957e9ca-4cf4-4440-8a9c-99de834cea37.html,,oral,LD50,"5,000 mg/kg bw",adverse effect observed, "Propane-1,2,3-triyl trisheptanoate",620-67-7,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8e1fe0d-a018-4acd-a48a-907533d05f48/documents/IUC5-100d09c9-bec5-46ea-87dd-82f55c82d3ca_0c50c0be-ad7f-4f1e-8048-7c7e84b9e4d0.html,,,,,, "Propane-1,2,3-triyl trisheptanoate",620-67-7,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8e1fe0d-a018-4acd-a48a-907533d05f48/documents/IUC5-694f4908-af3e-4729-afa2-3635b21d3d49_0c50c0be-ad7f-4f1e-8048-7c7e84b9e4d0.html,,,,,, "Triisodecyl benzene-1,2,4-tricarboxylate",36631-30-8,"In a 90 day repeated dose toxicity study in rats, the NOAEL in this study was considered to be >1000 mg/kg/day in males & females. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): OECD 408 study conducted to current guidelines. K1 assigned ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/881cb1d0-3e7a-4f1e-9ee5-b617772a0c28/documents/IUC5-110c815b-a863-4287-954f-1ca161e2e8f7_5991dfb3-3fa2-4694-bc8d-62afb45af8c2.html,,,,,, "Triisodecyl benzene-1,2,4-tricarboxylate",36631-30-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/881cb1d0-3e7a-4f1e-9ee5-b617772a0c28/documents/IUC5-110c815b-a863-4287-954f-1ca161e2e8f7_5991dfb3-3fa2-4694-bc8d-62afb45af8c2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Triisodecyl benzene-1,2,4-tricarboxylate",36631-30-8,"The acute oral median lethal dose (LD50)  of the test material in the female Wistar strain rat was found to be greater than 2000 mg/kg body weight. Dermal and inhalation toxicity studies are waived. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 1 study. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/881cb1d0-3e7a-4f1e-9ee5-b617772a0c28/documents/IUC5-dece3c82-f8af-43e0-b6a1-4a92fe29037e_5991dfb3-3fa2-4694-bc8d-62afb45af8c2.html,,,,,, "Triisodecyl benzene-1,2,4-tricarboxylate",36631-30-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/881cb1d0-3e7a-4f1e-9ee5-b617772a0c28/documents/IUC5-dece3c82-f8af-43e0-b6a1-4a92fe29037e_5991dfb3-3fa2-4694-bc8d-62afb45af8c2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Propane-1,2,3-triyl 3,5,5-trimethylhexanoate",56554-53-1," Subchronic (90-day) oral repeated dose toxicity (OECD 408): NOAEL (rat, m/f) = 120 mg/kg bw/day (worst-case assumption based on read-across from 3,5,5-trimethylhexanoic acid [CAS 3302-10-1]). Supported by additional subacute, subchronic and chronic studies with 3,5,5-trimethylhexanoic acid (CAS 3302-10-1), glycerol trioctanoate (CAS 538-23-8), propane-1,2,3-triyl 2-ethylhexanoate (CAS 7360-38-5), glycerides, C8-18 and C18-unsatd. mono- and di-, acetates (CAS 91052-13-0), and glycerol (CAS 56-81-5) accounted for in a Weight-of-Evidence approach. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/384bee85-7f2f-4eb5-82d4-4a105cf9ec95/documents/2e760201-f975-4587-9394-9e5e4ae74630_a1f7d309-d570-4424-a130-2d09d99820df.html,,,,,, "Propane-1,2,3-triyl 3,5,5-trimethylhexanoate",56554-53-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/384bee85-7f2f-4eb5-82d4-4a105cf9ec95/documents/2e760201-f975-4587-9394-9e5e4ae74630_a1f7d309-d570-4424-a130-2d09d99820df.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat "Propane-1,2,3-triyl 3,5,5-trimethylhexanoate",56554-53-1," Oral LD50 = 1253 mg/kg bw (worst-case assumption based on read-across from 3,5,5-trimethylhexanoic acid [CAS 3302-10-1] and after correction for differences in molecular weight and stoichiometry of full enzymatic hydrolysis) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/384bee85-7f2f-4eb5-82d4-4a105cf9ec95/documents/9854329b-8f3b-4249-bd79-4a1ac892b577_a1f7d309-d570-4424-a130-2d09d99820df.html,,,,,, "Propane-1,2,3-triyl 3,5,5-trimethylhexanoate",56554-53-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/384bee85-7f2f-4eb5-82d4-4a105cf9ec95/documents/9854329b-8f3b-4249-bd79-4a1ac892b577_a1f7d309-d570-4424-a130-2d09d99820df.html,,oral,LD50,"1,253 mg/kg bw",adverse effect observed, "1,1',1''-nitrilotripropan-2-ol",122-20-3," In a sub-chronic oral toxicity study in dogs, performed according to FDA guidelines, NOAELs of 272 mg/kg bw/day for males and 288 mg/kg bw/day for females were established, the highest doses tested. In a sub-acute dermal toxicity study in rats, performed according to OECD TG 410, NOAELs of 300 mg/kg bw/day (corresponding to 2.4 mg/cm2) for local effects (slightly irritative effects) and 3000 mg/kg bw/day (the highest dose tested) for systemic toxicity were established. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/527ae019-a06e-420e-ae03-0e472d3b6123/documents/IUC5-a5509df7-a091-4c49-965a-58a5eadd97f9_051e1bc7-b1f7-4b6a-a3de-53cad8613b7b.html,,,,,, "1,1',1''-nitrilotripropan-2-ol",122-20-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/527ae019-a06e-420e-ae03-0e472d3b6123/documents/IUC5-a5509df7-a091-4c49-965a-58a5eadd97f9_051e1bc7-b1f7-4b6a-a3de-53cad8613b7b.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"3,000 mg/kg bw/day",,rat "1,1',1''-nitrilotripropan-2-ol",122-20-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/527ae019-a06e-420e-ae03-0e472d3b6123/documents/IUC5-a5509df7-a091-4c49-965a-58a5eadd97f9_051e1bc7-b1f7-4b6a-a3de-53cad8613b7b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,272 mg/kg bw/day,,dog "1,1',1''-nitrilotripropan-2-ol",122-20-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/527ae019-a06e-420e-ae03-0e472d3b6123/documents/IUC5-a5509df7-a091-4c49-965a-58a5eadd97f9_051e1bc7-b1f7-4b6a-a3de-53cad8613b7b.html,Repeated dose toxicity – local effects,dermal,NOAEL,2.4 mg/cm2,adverse effect observed,rat "1,1',1''-nitrilotripropan-2-ol",122-20-3, Acute toxicity data indicate low toxicity: in rats the oral LD50 was 4000 mg/kg bw; in rabbits the dermal LD50 (24h) was > 5000 mg/kg bw. Inhalation exposure for 8 hours to vapour saturated with TIPA failed to cause any deaths in rats (LC50 was not determined). A 3-hour inhalation exposure to 329-1070 mg/m3 TIPA (aerosol) did not cause any mortality in mice. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/527ae019-a06e-420e-ae03-0e472d3b6123/documents/IUC5-6ae9aac9-05a8-4d9d-abc1-24f33f6a0793_051e1bc7-b1f7-4b6a-a3de-53cad8613b7b.html,,,,,, "1,1',1''-nitrilotripropan-2-ol",122-20-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/527ae019-a06e-420e-ae03-0e472d3b6123/documents/IUC5-6ae9aac9-05a8-4d9d-abc1-24f33f6a0793_051e1bc7-b1f7-4b6a-a3de-53cad8613b7b.html,,oral,LD50,"4,000 mg/kg bw",adverse effect observed, "1,1',1''-nitrilotripropan-2-ol",122-20-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/527ae019-a06e-420e-ae03-0e472d3b6123/documents/IUC5-6ae9aac9-05a8-4d9d-abc1-24f33f6a0793_051e1bc7-b1f7-4b6a-a3de-53cad8613b7b.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "1,2,3-propanetriyl triisooctadecanoate",26942-95-0,"Oral: similar to OECD 408, rat, NOAEL ≥ 5725 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b931bc83-dc48-4ef9-bdec-bc856eb7d8f5/documents/IUC5-e6503ec2-d44c-4b97-8b7b-f41530c36c99_5a9344a3-6108-47f7-a899-41c76c0adb8b.html,,,,,, "1,2,3-propanetriyl triisooctadecanoate",26942-95-0,Oral: LD50 > 2000 mg/kg bw Inhalation: LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles)Dermal: LD50 > 2000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b931bc83-dc48-4ef9-bdec-bc856eb7d8f5/documents/IUC5-d4e4096f-5751-4ae6-98b2-b0fc5461f57b_5a9344a3-6108-47f7-a899-41c76c0adb8b.html,,,,,, "Triisotridecyl benzene-1,2,4-tricarboxylate",72361-35-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex IX, 8.6, of Regulation (EC) No 1907/2006. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/327d1e8e-12dd-4e32-ac33-e97efb1f7be3/documents/ec0d511a-a6f6-47e6-8bd7-afd307928ee6_b537a774-345f-4a32-bb63-e906c000ecc5.html,,,,,, "Triisotridecyl benzene-1,2,4-tricarboxylate",72361-35-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/327d1e8e-12dd-4e32-ac33-e97efb1f7be3/documents/ec0d511a-a6f6-47e6-8bd7-afd307928ee6_b537a774-345f-4a32-bb63-e906c000ecc5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Triisotridecyl benzene-1,2,4-tricarboxylate",72361-35-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate and reliable studies from analogue source substances, and are thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No. 1907/2006. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/327d1e8e-12dd-4e32-ac33-e97efb1f7be3/documents/6f1147b7-4bf0-4f33-ab90-85c641cbc6ee_b537a774-345f-4a32-bb63-e906c000ecc5.html,,,,,, "Triisotridecyl benzene-1,2,4-tricarboxylate",72361-35-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/327d1e8e-12dd-4e32-ac33-e97efb1f7be3/documents/6f1147b7-4bf0-4f33-ab90-85c641cbc6ee_b537a774-345f-4a32-bb63-e906c000ecc5.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Tridodecylamine,102-87-4," Oral: Subacute Toxicity Study 28days, oral, rat, OECD 422, up to 400mg/kg bw/day tested: LOAEL >= 50mg/kg bw/d (BASF SE, 2013, 85R0674/12X380). Specific target organ toxicity: heart (cardiomyopathy) for read across substance Amines, tri-C8-10-alkyl. Dermal: No data available Inhalation: No data available ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24938000-6fc3-4569-85f3-2df9c7b20130/documents/2827b87e-5002-42e2-a475-d5bbd678b7e4_1362ca4c-b415-4350-bc46-d4d0059b16e8.html,,,,,, Tridodecylamine,102-87-4," Oral: - acute toxicity, oral, rat, Wistar, OECD 401 (limit test), LD50 >= (female/male) 2000 mg/kg bw, one death male and one death female for read across substance tri-n-octylamine Dermal: - acute toxicity, dermal, rat, Wistar, OECD 402, LD50 > (female/male) 5000mg/kg bw for read across substance Amines, tri-C8-10-alkyl Inhalation: - No information on acute inhalation available for trioctylamine ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24938000-6fc3-4569-85f3-2df9c7b20130/documents/d09d7fd8-3f5f-4b7f-8fdb-d7ca0808eae9_1362ca4c-b415-4350-bc46-d4d0059b16e8.html,,,,,, Trimagnesium bis(orthophosphate),7757-87-1, There are currently no reliable experimental data available to assess repeated dose toxicity for trimagnesium bis(orthophosphate). A data waiver is set in place to justify that no further repeated dose toxicity testing is required. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09f7f557-1342-4ec2-a5a8-68a824b1c8ce/documents/bc72503b-7745-4aa4-972b-aae5eea742c5_499922ba-0df5-492d-bc4b-a2b3485f5503.html,,,,,, Trimagnesium bis(orthophosphate),7757-87-1," Oral (OECD420, RL1), rat LD50 > 2000 mg/kg bw (limit test) There is no reliable data availabe regarding acute dermal toxicity for trimagnesium bis(orthophosphate). Read across data with calcium bis (dihydrogenorthophosphate) CAS 7758 -23 -8 is used and considered reliable. Dermal (similar to OECD 402, CAS 7758 -23 -8, RL2), rabbit, LD50 > 2000 mg/kg bw (limit test) There is no data regarding acute toxicity via inhalation route available for trimagnesium bis(orthophosphate). Read across data with calcium bis (dihydrogenorthophosphate) CAS 7758 -23 -8 is used and considered reliable. Inhalation (OECD 403, CAS 7758 -23 -8, RL1), rat LC50 > 2.6 mg/L air (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09f7f557-1342-4ec2-a5a8-68a824b1c8ce/documents/IUC5-55e88a1e-9818-44f0-a78b-015287b23581_499922ba-0df5-492d-bc4b-a2b3485f5503.html,,,,,, Trimagnesium bis(orthophosphate),7757-87-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09f7f557-1342-4ec2-a5a8-68a824b1c8ce/documents/IUC5-55e88a1e-9818-44f0-a78b-015287b23581_499922ba-0df5-492d-bc4b-a2b3485f5503.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Trimagnesium bis(orthophosphate),7757-87-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09f7f557-1342-4ec2-a5a8-68a824b1c8ce/documents/IUC5-55e88a1e-9818-44f0-a78b-015287b23581_499922ba-0df5-492d-bc4b-a2b3485f5503.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Trimagnesium bis(orthophosphate),7757-87-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09f7f557-1342-4ec2-a5a8-68a824b1c8ce/documents/IUC5-55e88a1e-9818-44f0-a78b-015287b23581_499922ba-0df5-492d-bc4b-a2b3485f5503.html,,inhalation,LC50,"2,600 mg/m3",no adverse effect observed, "Benzene-1,2,4-tricarboxylic acid 1,2-anhydride",552-30-7,"Trimellitic anhydride has been investigated in a number of oral studies in the rat and dog and are shown to be of low toxicity. In contrast, trimellitic anhydride is shown to cause immunological reactions in rats following inhalation exposure to low concentrations.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e0b281b-7cf1-4ddb-8075-a67c6a10af9e/documents/IUC5-7d67c25b-8b3a-40f4-9442-e55d55e1ac0f_1f764ab2-df2d-43f1-83ed-ceb1a0f8bab7.html,,,,,, "Benzene-1,2,4-tricarboxylic acid 1,2-anhydride",552-30-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e0b281b-7cf1-4ddb-8075-a67c6a10af9e/documents/IUC5-7d67c25b-8b3a-40f4-9442-e55d55e1ac0f_1f764ab2-df2d-43f1-83ed-ceb1a0f8bab7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,900 mg/kg bw/day,,rat "Benzene-1,2,4-tricarboxylic acid 1,2-anhydride",552-30-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e0b281b-7cf1-4ddb-8075-a67c6a10af9e/documents/IUC5-7d67c25b-8b3a-40f4-9442-e55d55e1ac0f_1f764ab2-df2d-43f1-83ed-ceb1a0f8bab7.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,50 ,, "Benzene-1,2,4-tricarboxylic acid 1,2-anhydride",552-30-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e0b281b-7cf1-4ddb-8075-a67c6a10af9e/documents/IUC5-7d67c25b-8b3a-40f4-9442-e55d55e1ac0f_1f764ab2-df2d-43f1-83ed-ceb1a0f8bab7.html,Repeated dose toxicity – local effects,inhalation,LOAEC,2 ,adverse effect observed, "Benzene-1,2,4-tricarboxylic acid 1,2-anhydride",552-30-7,"Trimellitic anhydride was found to be of low acute toxicity via the oral, dermal and inhalation routes. LD50 values of 2730 mg/kg bw (oral) and >2000 mg/kg bw (dermal) are reported. The acute inhalation LC50 was investigated in two studies and found to be >2.33 mg/L for the substance itself and >3.75 mg/L for the di-acid hydrolysis product, both of these being the maximum achievable respirable concentrations. The substance does not require classification for acute toxicity according to CLP. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e0b281b-7cf1-4ddb-8075-a67c6a10af9e/documents/IUC5-cc1fa91e-6466-4758-9c7a-a4f5a24fbecc_1f764ab2-df2d-43f1-83ed-ceb1a0f8bab7.html,,,,,, "Benzene-1,2,4-tricarboxylic acid 1,2-anhydride",552-30-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e0b281b-7cf1-4ddb-8075-a67c6a10af9e/documents/IUC5-cc1fa91e-6466-4758-9c7a-a4f5a24fbecc_1f764ab2-df2d-43f1-83ed-ceb1a0f8bab7.html,,oral,LD50,"2,730 mg/kg bw",adverse effect observed, "Benzene-1,2,4-tricarboxylic acid 1,2-anhydride",552-30-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e0b281b-7cf1-4ddb-8075-a67c6a10af9e/documents/IUC5-cc1fa91e-6466-4758-9c7a-a4f5a24fbecc_1f764ab2-df2d-43f1-83ed-ceb1a0f8bab7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzene-1,2,4-tricarboxylic acid 1,2-anhydride",552-30-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e0b281b-7cf1-4ddb-8075-a67c6a10af9e/documents/IUC5-cc1fa91e-6466-4758-9c7a-a4f5a24fbecc_1f764ab2-df2d-43f1-83ed-ceb1a0f8bab7.html,,inhalation,discriminating conc.,"2,330 mg/m3",adverse effect observed, "2,6,6-trimethoxy-2-vinyltetrahydropyran",7392-19-0,The acute oral toxicity of the test substance was assessed. The acute oral median lethal dose (LD50) is 2.8 g/kg with 95 % confidence limits of 2.24 – 3.50 g/kg for males. The LD50 is 2.75 g/kg with 95 % confidence limits of 2.27 – 3.33 g/kg for females. The LD50 is 2.70 g/kg with 95 % confidence limits of 2.31 – 3.16 g/kg for males and females. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22d8925f-6b8e-4a2d-93c1-ae33dcc62bce/documents/IUC5-14a813a0-53f8-4ded-8c62-1d280de4c2f6_b876d94c-4c20-4777-aaad-2b18332c00bd.html,,,,,, "2,6,6-trimethoxy-2-vinyltetrahydropyran",7392-19-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22d8925f-6b8e-4a2d-93c1-ae33dcc62bce/documents/IUC5-14a813a0-53f8-4ded-8c62-1d280de4c2f6_b876d94c-4c20-4777-aaad-2b18332c00bd.html,,oral,LD50,"2,700 mg/kg bw",no adverse effect observed, Trimethoxyoctylsilane,3069-40-7," In the key 90-day oral repeated dose toxicity study with trimethoxy(octyl)silane, conducted according to OECD Test Guideline 408 and in compliance with GLP, the systemic NOAEL was concluded to be 175 mg/kg bw/day based on no observed adverse systemic effects up to the highest dose tested (BSL Bioservice, 2020). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5854326e-12b3-4ab6-8e14-0f5df50ed258/documents/02b7b0fe-f863-403c-968e-ebb52e5c7bb3_88766b04-0744-4ef4-883e-346656773556.html,,,,,, Trimethoxyoctylsilane,3069-40-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5854326e-12b3-4ab6-8e14-0f5df50ed258/documents/02b7b0fe-f863-403c-968e-ebb52e5c7bb3_88766b04-0744-4ef4-883e-346656773556.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,175 mg/kg bw/day,,rat Trimethoxyoctylsilane,3069-40-7," In an acute oral toxicity study that was comparable to the now deleted OECD Test Guideline 401, but not in compliance with GLP (reliability score 2) the LD50 was at least 3500 mg/kg bw for male and female rats (ASTA Pharma AG, 1988). In an inhalation study conducted according to OECD Test Guideline 403 and in compliance with GLP (reliability score 1) the LC50 for 4-hour aerosol exposure to trimethoxy(octyl)silane was 7.5 and 1.9 g/m3 for males and females, respectively (TNO-CIVO, 1990). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5854326e-12b3-4ab6-8e14-0f5df50ed258/documents/cb816dcd-51d1-4de6-b9ac-43cf1f67f697_88766b04-0744-4ef4-883e-346656773556.html,,,,,, Trimethoxyoctylsilane,3069-40-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5854326e-12b3-4ab6-8e14-0f5df50ed258/documents/cb816dcd-51d1-4de6-b9ac-43cf1f67f697_88766b04-0744-4ef4-883e-346656773556.html,,oral,LD50,"3,500 mg/kg bw",adverse effect observed, Trimethoxyoctylsilane,3069-40-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5854326e-12b3-4ab6-8e14-0f5df50ed258/documents/cb816dcd-51d1-4de6-b9ac-43cf1f67f697_88766b04-0744-4ef4-883e-346656773556.html,,inhalation,LC50,"3,900 mg/m3",adverse effect observed, "Isobutyric acid, monoester with 2,2,4-trimethylpentane-1,3-diol",25265-77-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9c1b5df-4801-4004-8b12-fbf40ec29672/documents/IUC5-afadd61d-3528-4083-a511-f80a9678189e_0e00ee51-62d7-4e5e-bd1f-827c19341ef9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "1-isopropyl-2,2-dimethyltrimethylene diisobutyrate",6846-50-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22566ea8-26e1-4a4c-b3e0-51664f5b369b/documents/IUC5-5d6c7807-f5db-478c-99f5-ee005eb125a1_21816a1c-40de-4741-a62c-fc1bbb7b1d16.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,, "1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane",3390-61-2," In a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test, performed according to OECD TG 408/422 with acceptable restrictions, and in compliance with GLP, no biologically significant, treatment-related effects were reported in rats given 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane by oral gavage at 100, 500, 1000 mg/kg bw/day. A NOAEL of ≥1000 mg/kg bw/day was derived (DCC, 2005). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/796f8bef-7e07-421f-a056-d5bd0c2f2639/documents/9d065c1c-b84a-4bd7-8f4f-30895ea2b0b3_a5c37c6c-65f8-4fbb-979f-9ad43004a129.html,,,,,, "1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane",3390-61-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/796f8bef-7e07-421f-a056-d5bd0c2f2639/documents/9d065c1c-b84a-4bd7-8f4f-30895ea2b0b3_a5c37c6c-65f8-4fbb-979f-9ad43004a129.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane",3390-61-2," In the key acute oral toxicity study, conducted according to OECD TG 423, and in compliance with GLP, an LD50 value of >2000 mg/kg bw was reported (LPT, 2002). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/796f8bef-7e07-421f-a056-d5bd0c2f2639/documents/bee1532e-0872-46ff-8d13-d966d5820e5d_a5c37c6c-65f8-4fbb-979f-9ad43004a129.html,,,,,, "1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane",3390-61-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/796f8bef-7e07-421f-a056-d5bd0c2f2639/documents/bee1532e-0872-46ff-8d13-d966d5820e5d_a5c37c6c-65f8-4fbb-979f-9ad43004a129.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2,4-trimethylpentane-1,3-diol",144-19-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcb7eb95-612a-42da-9254-5dcf10174661/documents/IUC5-17249343-47d4-4c85-a8a3-b8efe8aaa262_dbbfc280-df9c-4a2f-bcb1-df460c72c61c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2,4-trimethylpentane-1,3-diol",144-19-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcb7eb95-612a-42da-9254-5dcf10174661/documents/IUC5-17249343-47d4-4c85-a8a3-b8efe8aaa262_dbbfc280-df9c-4a2f-bcb1-df460c72c61c.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "3-Pentanone, 1-(2,6,6-trimethyl-2-cyclohexen-1-yl)-, reaction products with 2-propyn-1-ol",68611-23-4,Acute oral toxicity: OECD TG 401: > 5000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8266c04b-b6ee-4921-a33b-01daac81ab23/documents/IUC5-66daa966-a23c-4911-90f3-88048a668139_567d8527-a6e5-4331-8071-31fe213a8405.html,,,,,, "2,2,3-trimethylcyclopent-3-enylacetonitrile",15373-31-6,oral:The LD50 value was found to be greater than 2000 mg/kg bw in rats. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/855e66db-115b-408e-a0a4-9cc49667f7a3/documents/IUC5-4c40c81d-c937-492d-ae62-fc386cf33808_25542f14-a28b-4c29-b63e-4020f8acc619.html,,,,,, "2,2,3-trimethylcyclopent-3-enylacetonitrile",15373-31-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/855e66db-115b-408e-a0a4-9cc49667f7a3/documents/IUC5-4c40c81d-c937-492d-ae62-fc386cf33808_25542f14-a28b-4c29-b63e-4020f8acc619.html,,oral,discriminating dose,"2,021 mg/kg bw",no adverse effect observed, "2,2,5-trimethyl-5-pentylcyclopentan-1-one",65443-14-3,"Repeated dose toxicity oral: NOAEL = 683 mg/kg bw/day in female rats; NOAEL = 704 mg/kg bw/day in male rats (OECD 422, K, rel. 1). Absence of significant effects that could be considered to be adverse at the highest dose tested and below. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb40fb3e-b7be-4772-a333-290ea94c69e0/documents/IUC5-2dbbcaf1-0141-4ace-a38c-ed2447911c0c_913fac7a-55c1-4cbb-8320-50e56d473d72.html,,,,,, "2,2,5-trimethyl-5-pentylcyclopentan-1-one",65443-14-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb40fb3e-b7be-4772-a333-290ea94c69e0/documents/IUC5-2dbbcaf1-0141-4ace-a38c-ed2447911c0c_913fac7a-55c1-4cbb-8320-50e56d473d72.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,683 mg/kg bw/day,,rat "2,2,5-trimethyl-5-pentylcyclopentan-1-one",65443-14-3,"Acute toxicity: oral: LD50 > 6834 mg/kg bw (similar to OECD 401 in rats, K, rel.2);Acute toxicity: dermal: LD50 > 2000 mg/kg bw (similar to OECD 402 in rabbits, WoE);Acute toxicity: inhalation: waiver. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb40fb3e-b7be-4772-a333-290ea94c69e0/documents/IUC5-1926f54d-3a2d-4498-ac9c-1d6dcde0ac84_913fac7a-55c1-4cbb-8320-50e56d473d72.html,,,,,, "2,2,5-trimethyl-5-pentylcyclopentan-1-one",65443-14-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb40fb3e-b7be-4772-a333-290ea94c69e0/documents/IUC5-1926f54d-3a2d-4498-ac9c-1d6dcde0ac84_913fac7a-55c1-4cbb-8320-50e56d473d72.html,,oral,LD50,"6,834 mg/kg bw",no adverse effect observed, "2,2,5-trimethyl-5-pentylcyclopentan-1-one",65443-14-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb40fb3e-b7be-4772-a333-290ea94c69e0/documents/IUC5-1926f54d-3a2d-4498-ac9c-1d6dcde0ac84_913fac7a-55c1-4cbb-8320-50e56d473d72.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,2,4-trimethylbenzene",95-63-6,"1,2,4-Trimethylbenzene (when read-across from the isomer 1,3,5-Trimethylbenzene) has low systemic toxicity when administered by oral gavage to the rat. 1,2,4-Trimethylbenzene also has low systemic toxicity when inhaled in the rat. No significant treatment-related effects were observed for oral doses up to 600 mg/kg/day or inhaled concentrations up to 1800 mg/m3. Mild pulmonary lesions occurred, possibly as a result of respiratory irritation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fe0f2af-2d7d-4e0d-9ebc-8aeb5549f4ee/documents/IUC5-4f33d0cc-5fd1-4473-9382-5ca9d7b30665_e809d52c-3151-43e3-8b20-ea7eb4d23636.html,,,,,, "1,2,4-trimethylbenzene",95-63-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fe0f2af-2d7d-4e0d-9ebc-8aeb5549f4ee/documents/IUC5-4f33d0cc-5fd1-4473-9382-5ca9d7b30665_e809d52c-3151-43e3-8b20-ea7eb4d23636.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat "1,2,4-trimethylbenzene",95-63-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fe0f2af-2d7d-4e0d-9ebc-8aeb5549f4ee/documents/IUC5-4f33d0cc-5fd1-4473-9382-5ca9d7b30665_e809d52c-3151-43e3-8b20-ea7eb4d23636.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,800 mg/m3",,rat "1,2,4-trimethylbenzene",95-63-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fe0f2af-2d7d-4e0d-9ebc-8aeb5549f4ee/documents/IUC5-4f33d0cc-5fd1-4473-9382-5ca9d7b30665_e809d52c-3151-43e3-8b20-ea7eb4d23636.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,800 mg/m3",no adverse effect observed,rat "1,2,4-trimethylbenzene",95-63-6,"The acute oral and dermal LD50 values for 1,2,4-Trimethylbenzene are concluded to be greater than 3000 mg/kg. In acute inhalation studies, the LC50 is reported as 18,000 mg/m3. In human volunteer studies, no effects were reported at concentrations up to 150 mg/m3. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fe0f2af-2d7d-4e0d-9ebc-8aeb5549f4ee/documents/IUC5-b3e276c9-0327-4560-93e6-bed5465d3e15_e809d52c-3151-43e3-8b20-ea7eb4d23636.html,,,,,, "1,2,4-trimethylbenzene",95-63-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fe0f2af-2d7d-4e0d-9ebc-8aeb5549f4ee/documents/IUC5-b3e276c9-0327-4560-93e6-bed5465d3e15_e809d52c-3151-43e3-8b20-ea7eb4d23636.html,,oral,LD50,"6,000 mg/kg bw",adverse effect observed, "1,2,4-trimethylbenzene",95-63-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fe0f2af-2d7d-4e0d-9ebc-8aeb5549f4ee/documents/IUC5-b3e276c9-0327-4560-93e6-bed5465d3e15_e809d52c-3151-43e3-8b20-ea7eb4d23636.html,,dermal,LD50,"> 3,440 mg/kg bw",no adverse effect observed, "1,2,4-trimethylbenzene",95-63-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fe0f2af-2d7d-4e0d-9ebc-8aeb5549f4ee/documents/IUC5-b3e276c9-0327-4560-93e6-bed5465d3e15_e809d52c-3151-43e3-8b20-ea7eb4d23636.html,,inhalation,LC50,"> 10,200 mg/m3",no adverse effect observed, "3-(2,2-dimethyl-3-hydroxypropyl)toluene",103694-68-4,"In a key subacute oral repeated dose toxicity study in rats according to OECD guideline 407, the NOAEL was 317.5 mg/kg bw/day (males) or  310 mg/kg bw/day (females). In a supporting 14-day repeated dose palatibility study in rats similar to OECD guideline 407, the NOEL was found to be 373.9 mg/kg bw/day (males) or 737.2 (females) mg/kg bw/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP and guideline study ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2074d701-00b7-42e0-b0d3-5c1d61986961/documents/144fdd76-f954-4629-b92a-d0ff51f30090_b305bc48-e4a8-4a4d-9f52-693fa63769af.html,,,,,, "3-(2,2-dimethyl-3-hydroxypropyl)toluene",103694-68-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2074d701-00b7-42e0-b0d3-5c1d61986961/documents/144fdd76-f954-4629-b92a-d0ff51f30090_b305bc48-e4a8-4a4d-9f52-693fa63769af.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,310 mg/kg bw/day,,rat "3-(2,2-dimethyl-3-hydroxypropyl)toluene",103694-68-4, Acute oral toxicity: LD50 > 2000 mg/kg bw Acute dermal toxicity: LD50 > 5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2074d701-00b7-42e0-b0d3-5c1d61986961/documents/9052eb1b-68f2-49a7-8c1a-86715090e7a6_b305bc48-e4a8-4a4d-9f52-693fa63769af.html,,,,,, "3-(2,2-dimethyl-3-hydroxypropyl)toluene",103694-68-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2074d701-00b7-42e0-b0d3-5c1d61986961/documents/9052eb1b-68f2-49a7-8c1a-86715090e7a6_b305bc48-e4a8-4a4d-9f52-693fa63769af.html,,oral,LD50,"3,460 mg/kg bw",adverse effect observed, "3-(2,2-dimethyl-3-hydroxypropyl)toluene",103694-68-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2074d701-00b7-42e0-b0d3-5c1d61986961/documents/9052eb1b-68f2-49a7-8c1a-86715090e7a6_b305bc48-e4a8-4a4d-9f52-693fa63769af.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide",75980-60-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3c15ab6-256a-4f87-848e-9b70688a4740/documents/IUC5-3193fa9a-2998-4fe1-a323-fd21505efee7_f070acb9-e0b3-4e42-9b42-a381efa04814.html,,,,,, "Diphenyl(2,4,6-trimethylbenzoyl)phosphine oxide",75980-60-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3c15ab6-256a-4f87-848e-9b70688a4740/documents/IUC5-3193fa9a-2998-4fe1-a323-fd21505efee7_f070acb9-e0b3-4e42-9b42-a381efa04814.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "3,3,5-trimethylcyclohexyl acrylate",86178-38-3," In the 28 -day repeated toxicity study (OECD 422), 3,3,5 -trimethylcyclohexyl acrylate was administered daily by oral gavage to male and female Sprague Dawley rats, for 4 weeks for males and at least 7 weeks for females, at the doses of 100, 300 and 1000 mg/kg bw/day. No adverse effect was observed in this study at any doses. Therefore, based on the experimental conditions of this study: the NOAEL for parental toxicity was 1000 mg/kg/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d12bc1a7-5373-4ff7-9dcb-0a3ed25740d8/documents/2c6c5500-6934-4c26-9b87-c9e44b83278e_93ec0deb-f5f6-435a-b903-6fc29955dea2.html,,,,,, "3,3,5-trimethylcyclohexyl acrylate",86178-38-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d12bc1a7-5373-4ff7-9dcb-0a3ed25740d8/documents/2c6c5500-6934-4c26-9b87-c9e44b83278e_93ec0deb-f5f6-435a-b903-6fc29955dea2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,3,5-trimethylcyclohexyl acrylate",86178-38-3, The acute toxicity of 3.3.5 -trimethylcyclohexyl acrylate was evaluated by oral and dermal route in rats. No mortality was observed at the highest dose of 2000 mg/kg bw in both studies. No acute toxicity study is available by inhalation. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d12bc1a7-5373-4ff7-9dcb-0a3ed25740d8/documents/IUC5-69684015-dcc6-4a55-9b78-4364820943c5_93ec0deb-f5f6-435a-b903-6fc29955dea2.html,,,,,, "3,3,5-trimethylcyclohexyl acrylate",86178-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d12bc1a7-5373-4ff7-9dcb-0a3ed25740d8/documents/IUC5-69684015-dcc6-4a55-9b78-4364820943c5_93ec0deb-f5f6-435a-b903-6fc29955dea2.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3,3,5-trimethylcyclohexyl acrylate",86178-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d12bc1a7-5373-4ff7-9dcb-0a3ed25740d8/documents/IUC5-69684015-dcc6-4a55-9b78-4364820943c5_93ec0deb-f5f6-435a-b903-6fc29955dea2.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3,5,5-trimethylhexan-1-ol",3452-97-9,"Significantly increased liver and kidney weights were seen in male and female in rats receiving oral doses of 60 mg 3,5,5-trimethylhexan-1-ol/kg bw/d for approx. 40 days in an OECD 422 screening study. The NOAEL was 12 mg/kg bw/day for males and females. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/866203ae-0c07-4b2e-b19b-242a0f10a841/documents/IUC5-9bdc3a71-d9a5-4a39-8a2b-df53c6a5d4de_ba2f923b-818c-471d-b57c-f20f73dfc164.html,,,,,, "3,5,5-trimethylhexan-1-ol",3452-97-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/866203ae-0c07-4b2e-b19b-242a0f10a841/documents/IUC5-9bdc3a71-d9a5-4a39-8a2b-df53c6a5d4de_ba2f923b-818c-471d-b57c-f20f73dfc164.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,12 mg/kg bw/day,,rat "3,5,5-trimethylhexan-1-ol",3452-97-9,"3,5,5-trimethylhexan-1-ol is of moderate acute oral and dermal toxicity (both the LD50 (oral, rat) and the LD50 (dermal, rabbit) were >2000 mg/kg). No target organ could be identified.The vapor pressure of isononanol is too low to cause toxic atmospheres. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/866203ae-0c07-4b2e-b19b-242a0f10a841/documents/IUC5-2a87466c-007c-46f9-872c-e803f0e4c4d7_ba2f923b-818c-471d-b57c-f20f73dfc164.html,,,,,, "3,5,5-trimethylhexan-1-ol",3452-97-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/866203ae-0c07-4b2e-b19b-242a0f10a841/documents/IUC5-2a87466c-007c-46f9-872c-e803f0e4c4d7_ba2f923b-818c-471d-b57c-f20f73dfc164.html,,oral,LD50,"2,000 mg/kg bw",, "3,5,5-trimethylhexan-1-ol",3452-97-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/866203ae-0c07-4b2e-b19b-242a0f10a841/documents/IUC5-2a87466c-007c-46f9-872c-e803f0e4c4d7_ba2f923b-818c-471d-b57c-f20f73dfc164.html,,dermal,LD50,"2,307 mg/kg bw",, "3,5,5-trimethylhexyl acetate",58430-94-7," In a subchronic repeated dose oral toxicity study with rats, according to OECD 408, a NOAEL was determined to be 80 mg/kg bw/day.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8263d5c7-29eb-4e68-8927-a09813f4da6e/documents/c55c29d1-5ccd-4c66-b147-7bbbb8da509b_4004a4b8-d035-46a2-8b3a-e8cc3d3700c8.html,,,,,, "3,5,5-trimethylhexyl acetate",58430-94-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8263d5c7-29eb-4e68-8927-a09813f4da6e/documents/c55c29d1-5ccd-4c66-b147-7bbbb8da509b_4004a4b8-d035-46a2-8b3a-e8cc3d3700c8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat "3,5,5-trimethylhexyl acetate",58430-94-7, The registration item was not acutely toxic to animals.   ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8263d5c7-29eb-4e68-8927-a09813f4da6e/documents/acf2acbc-e14f-43a9-8817-3c680761098a_4004a4b8-d035-46a2-8b3a-e8cc3d3700c8.html,,,,,, "3,5,5-trimethylhexyl acetate",58430-94-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8263d5c7-29eb-4e68-8927-a09813f4da6e/documents/acf2acbc-e14f-43a9-8817-3c680761098a_4004a4b8-d035-46a2-8b3a-e8cc3d3700c8.html,,oral,LD50,"4,250 mg/kg bw",adverse effect observed, "3,5,5-trimethylhexyl acetate",58430-94-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8263d5c7-29eb-4e68-8927-a09813f4da6e/documents/acf2acbc-e14f-43a9-8817-3c680761098a_4004a4b8-d035-46a2-8b3a-e8cc3d3700c8.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "1,3,3-trimethylnorbornan-2-one",7787-20-4," Acute oral toxicity: Key study. Test method according to OECD 423, GLP study. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off may be considered to be 5000 mg/kg body weight by oral route in the rat. Acute oral toxicity: supporting study. Read across aproach. Based on the read-across approach from the analogue d-fenchone, the LD50 of l-fenchone is 6160 mg/kg body weight by oral route in the rat. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c649b2d-20a7-4efa-ad10-78f05fef4a84/documents/17dec0f6-2a00-408a-bc68-65e2f3fac311_6f1030a8-d5ed-44b9-bdba-415cb02c8092.html,,,,,, "1,3,3-trimethylnorbornan-2-one",7787-20-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c649b2d-20a7-4efa-ad10-78f05fef4a84/documents/17dec0f6-2a00-408a-bc68-65e2f3fac311_6f1030a8-d5ed-44b9-bdba-415cb02c8092.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Propylidynetrimethanol,77-99-6,"Subchronic toxicity study performed prior to implementation of official testing guidelines but comparable to OECD TG 408. The feeding of trimethylolpropane to young male and female Wistar rats at 0, 0.03, 0.1, 0.3, 1.0 % in diet (corresponding to 20, 67, 200 or 667 mg/kg bw/d) for three months led to a NOAEL of 0.1 % in diet corresponding to 67 mg/kg bw/day (de Knecht - van Eekelen, 1969 a und b).No valid studies are available for inhalation or dermal repeated dose toxicity. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/23370813-6a12-4eee-a2d9-92e2ddfa626a/documents/IUC5-8cb32b60-032d-4b66-b35a-ff1662dde769_2729d270-9b0e-473e-a733-4c1d5a27646d.html,,,,,, Propylidynetrimethanol,77-99-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/23370813-6a12-4eee-a2d9-92e2ddfa626a/documents/IUC5-8cb32b60-032d-4b66-b35a-ff1662dde769_2729d270-9b0e-473e-a733-4c1d5a27646d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,67 mg/kg bw/day,,rat Propylidynetrimethanol,77-99-6,"Acute oral toxicity study performed prior to implementation of official testing guidelines but comparable to OECD TG 401: 5 male rats were given single oral doses of 1000, 2150, 4640, 10000 or 21500 mg/kg bw and observed for 7 days. The LD50 value was determined to be 14700 mg/kg bw (Celanese Corporation 1956).Acute dermal toxicity study performed prior to implementation of official testing guidelines but comparable to OECD TG 402: Groups of 4 albino rabbits were evaluated for acute dermal toxicity following single dermal application of 1000, 2150, 4640, 10000 mg/kg bw as paste for 24 hours and a post exposure observation period of 7 days. The LD50 after single application is >10000 mg/kg bw (Celanese Corporation 1956).Acute inhalation toxicity study performed prior to implementation of official testing guidelines but similar to OECD TG 403: 20 male rats were whole body exposed to 590 mg/m³ or 850 mg/m³ (analytical) trimethylolpropane for 4 hours and observed for 14 days. No mortalities and no clinical signs of toxicity were reported up to and including the highest exposure level of 850 mg/m³ (Bayer 1965). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23370813-6a12-4eee-a2d9-92e2ddfa626a/documents/IUC5-b0a38418-587d-496a-a1a8-d45a1162f366_2729d270-9b0e-473e-a733-4c1d5a27646d.html,,,,,, Propylidynetrimethanol,77-99-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23370813-6a12-4eee-a2d9-92e2ddfa626a/documents/IUC5-b0a38418-587d-496a-a1a8-d45a1162f366_2729d270-9b0e-473e-a733-4c1d5a27646d.html,,oral,LD50,"14,700 mg/kg bw",no adverse effect observed, Propylidynetrimethanol,77-99-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23370813-6a12-4eee-a2d9-92e2ddfa626a/documents/IUC5-b0a38418-587d-496a-a1a8-d45a1162f366_2729d270-9b0e-473e-a733-4c1d5a27646d.html,,inhalation,discriminating conc.,850 mg/m3,no adverse effect observed, "2,2-bis(allyloxymethyl)butan-1-ol",682-09-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/205748b8-5549-4933-93aa-9c32b0feb8a8/documents/6f59f0c4-0624-4d5f-991e-403bdbbfe181_7d6f5fff-4588-4dfe-9b2f-516a9a080081.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,ca.200 mg/kg bw/day,,rat "2,2-bis(allyloxymethyl)butan-1-ol",682-09-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/205748b8-5549-4933-93aa-9c32b0feb8a8/documents/6f59f0c4-0624-4d5f-991e-403bdbbfe181_7d6f5fff-4588-4dfe-9b2f-516a9a080081.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "2,2-bis(allyloxymethyl)butan-1-ol",682-09-7,The acute oral LD50 of trimethylol diallyl ether (TMPDE) in the rat is reported to be >2000 mg/kg bw . The dermal LD50 of TMPDE in the rabbit was found to be >3000 mg/kg bw. A waiver is proposed for acute inhalation toxicity.   ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/205748b8-5549-4933-93aa-9c32b0feb8a8/documents/3e6a20cc-083e-4c89-8f86-0cf90e2fc375_7d6f5fff-4588-4dfe-9b2f-516a9a080081.html,,,,,, "2,2-bis(allyloxymethyl)butan-1-ol",682-09-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/205748b8-5549-4933-93aa-9c32b0feb8a8/documents/3e6a20cc-083e-4c89-8f86-0cf90e2fc375_7d6f5fff-4588-4dfe-9b2f-516a9a080081.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,2-bis(allyloxymethyl)butan-1-ol",682-09-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/205748b8-5549-4933-93aa-9c32b0feb8a8/documents/3e6a20cc-083e-4c89-8f86-0cf90e2fc375_7d6f5fff-4588-4dfe-9b2f-516a9a080081.html,,dermal,LD50,"> 3,000 mg/kg bw",no adverse effect observed, "2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate; 2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate",15625-89-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Only supportive evidence Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): Only supportive evidence Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): High quality study performed according to OECD 408 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba35f2fb-1f20-488f-9b8b-636b5ab6d8a8/documents/2bb35fa4-10cf-441a-b280-8a04292df621_f7b00c25-a540-43a1-9a11-9020a5270bd3.html,,,,,, "2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate; 2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate",15625-89-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba35f2fb-1f20-488f-9b8b-636b5ab6d8a8/documents/2bb35fa4-10cf-441a-b280-8a04292df621_f7b00c25-a540-43a1-9a11-9020a5270bd3.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rabbit "2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate; 2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate",15625-89-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba35f2fb-1f20-488f-9b8b-636b5ab6d8a8/documents/2bb35fa4-10cf-441a-b280-8a04292df621_f7b00c25-a540-43a1-9a11-9020a5270bd3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,173 mg/kg bw/day,,rat "2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate; 2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate",15625-89-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Two studies available (key and supporting), both with a klimisch score of 2. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Two studies available (both weight of evidence) with a klimisch score of 2 and 3. No toxicity observed i.e. LC50 > 0.55 mg/L ( > 550 mg/m³) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Two studies available (key and supporting), both with a klimisch score of 2. Low toxicity i.e. LD50 > 2000 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba35f2fb-1f20-488f-9b8b-636b5ab6d8a8/documents/10de705a-5a40-4354-86b4-71698aa4a498_f7b00c25-a540-43a1-9a11-9020a5270bd3.html,,,,,, "2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate; 2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate",15625-89-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba35f2fb-1f20-488f-9b8b-636b5ab6d8a8/documents/10de705a-5a40-4354-86b4-71698aa4a498_f7b00c25-a540-43a1-9a11-9020a5270bd3.html,,oral,LD50,"3,680 mg/kg bw",no adverse effect observed, "2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate; 2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate",15625-89-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba35f2fb-1f20-488f-9b8b-636b5ab6d8a8/documents/10de705a-5a40-4354-86b4-71698aa4a498_f7b00c25-a540-43a1-9a11-9020a5270bd3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-ethyl-2-[[(1-oxoallyl)oxy]methyl]-1,3-propanediyl diacrylate; 2,2-bis(acryloyloxymethyl)butyl acrylate; trimethylolpropane triacrylate",15625-89-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba35f2fb-1f20-488f-9b8b-636b5ab6d8a8/documents/10de705a-5a40-4354-86b4-71698aa4a498_f7b00c25-a540-43a1-9a11-9020a5270bd3.html,,inhalation,LC50,550 mg/m3,no adverse effect observed, "2-ethyl-2-[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate)",68541-50-4,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category. All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f4ca38b-0db7-484b-8c2b-b8c8134441ea/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_2969c65b-17b4-4d57-9474-8162e09932b1.html,,,,,, "2-ethyl-2-[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate)",68541-50-4,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f4ca38b-0db7-484b-8c2b-b8c8134441ea/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_2969c65b-17b4-4d57-9474-8162e09932b1.html,,,,,, Propylidynetrimethyl trimethacrylate,3290-92-4,"In oral 90-d subchronic study (2015), some systemic (lower body weight and food consumption, lower liver and kidney weight...) and local (on stomach) effects were observed at the highest dose. The NOAEL for systemic toxicity was of 300 mg/kg bw/day in rats. These effects were not observed in the oral 28-d performed in 2010. In the 14-d dermal study, local effects were observed in rabbit in absence of systemic effects at 300 mg/kg/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): The subacute dermal study is considered to be reliable; it is a good range-finding study. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): The subacute dermal study is considered to be reliable; it is a good range-finding study. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The oral study is considered to be reliable, and was performed according to the OECD 408 guideline. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00f0aba2-0dce-43ec-8094-e6b214d9ea7e/documents/IUC5-5ebefabb-4371-4ade-9d46-c5e0c1ce4c17_9b1560e7-9e44-4788-9f5f-731e2f81a21b.html,,,,,, Propylidynetrimethyl trimethacrylate,3290-92-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00f0aba2-0dce-43ec-8094-e6b214d9ea7e/documents/IUC5-5ebefabb-4371-4ade-9d46-c5e0c1ce4c17_9b1560e7-9e44-4788-9f5f-731e2f81a21b.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,300 mg/kg bw/day,,rabbit Propylidynetrimethyl trimethacrylate,3290-92-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00f0aba2-0dce-43ec-8094-e6b214d9ea7e/documents/IUC5-5ebefabb-4371-4ade-9d46-c5e0c1ce4c17_9b1560e7-9e44-4788-9f5f-731e2f81a21b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Propylidynetrimethyl trimethacrylate,3290-92-4,"Both oral and dermal acute toxicity studies were available on TMPTMA. Oral and dermal LD50 are higher than 2000 mg/kg bw in rats. An acute toxicity study is available by intraperitoneal route: the ip LD50 for propylidynetrimethyl trimethacrylate is 3900 mg/kg bw in male and female rats.No study is available by inhalation but this route of exposure does not need to be further investigated in accordance with Annex VIII of REACH. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The oral acute study is considered to be reliable, and was performed according to the OECD guidelines. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The dermal acute study is considered to be reliable, and was performed according to the OECD guidelines. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00f0aba2-0dce-43ec-8094-e6b214d9ea7e/documents/IUC5-326fedbf-47e5-446c-aeda-ad4d21ee7675_9b1560e7-9e44-4788-9f5f-731e2f81a21b.html,,,,,, Propylidynetrimethyl trimethacrylate,3290-92-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00f0aba2-0dce-43ec-8094-e6b214d9ea7e/documents/IUC5-326fedbf-47e5-446c-aeda-ad4d21ee7675_9b1560e7-9e44-4788-9f5f-731e2f81a21b.html,,oral,LD0,"2,000 mg/kg bw",no adverse effect observed, Propylidynetrimethyl trimethacrylate,3290-92-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00f0aba2-0dce-43ec-8094-e6b214d9ea7e/documents/IUC5-326fedbf-47e5-446c-aeda-ad4d21ee7675_9b1560e7-9e44-4788-9f5f-731e2f81a21b.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, "2-ethyl-2-[(3-mercapto-1-oxopropoxy)methyl]propane-1,3-diyl bis[3-mercaptopropionate]",33007-83-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1337f8a2-f1db-45ce-93a5-9f8d8f2eb943/documents/530e2e84-6408-4a7b-b55d-4953cc984420_13cbd7bf-6190-44e2-b90c-d9dce517c51c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat "2-ethyl-2-[(3-mercapto-1-oxopropoxy)methyl]propane-1,3-diyl bis[3-mercaptopropionate]",33007-83-9,"Based on read across from PETMP, TMPMP is assumed to be harmful if swallowed (LD50 > 815 < 1630 mg/kg bw) and non-toxic if inhaled (no mortality at highest attainable concentration). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): not required since data on two other routes of exposure are available ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1337f8a2-f1db-45ce-93a5-9f8d8f2eb943/documents/0789077a-c8f6-4723-91a2-6a379c6d8e39_13cbd7bf-6190-44e2-b90c-d9dce517c51c.html,,,,,, "2-ethyl-2-[(3-mercapto-1-oxopropoxy)methyl]propane-1,3-diyl bis[3-mercaptopropionate]",33007-83-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1337f8a2-f1db-45ce-93a5-9f8d8f2eb943/documents/0789077a-c8f6-4723-91a2-6a379c6d8e39_13cbd7bf-6190-44e2-b90c-d9dce517c51c.html,,oral,LD50,ca.815 mg/kg bw,adverse effect observed, "2-ethyl-2-[(3-mercapto-1-oxopropoxy)methyl]propane-1,3-diyl bis[3-mercaptopropionate]",33007-83-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1337f8a2-f1db-45ce-93a5-9f8d8f2eb943/documents/0789077a-c8f6-4723-91a2-6a379c6d8e39_13cbd7bf-6190-44e2-b90c-d9dce517c51c.html,,inhalation,LC50,"> 2,700 mg/m3",no adverse effect observed, "[1R-(1α,2α,5β,8β)]-4,4,8-trimethyltricyclo[6.3.1.02,5]dodecan-1-yl acetate",57082-24-3," Acute oral toxicity:  Acute oral toxicity dose (LD50) of [1R-(1α,2α,5β,8β)]-4,4,8-trimethyltricyclo [6.3.1.02,5]dodecan-1-yl acetate (CAS no: 57082-24-3) was considered to be >5000 mg/kg bw, based on experimental study conducted by D. L. J. Opdyke (Food and Cosmetics Toxicology, Vol. 12, Pg. 839, 1974), Richard J. Lewis (Sax's Dangerous Properties of Industrial Materials, 12th Edition, 5 Volume Set, 2012), U.S. National Library of Medicine (ChemIDplus,2017) and U.S. Environmental Protection Agency (Chemistry Dashboard, 2018); predicted study based on OECD QSAR toolbox 4069 mg/kg bw and different studies available on structurally similar read across substances [3R-(3α,3aβ,6α,7β,8aα)]-Octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl acetate (CAS no: 77-54-3) 44750 mg/kg bw; and 2-tert-butylcyclohexyl acetate (CAS no: 88-41-5) 4600 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, [1R-(1α,2α,5β,8β)]-4,4,8-trimethyltricyclo [6.3.1.02,5]dodecan-1-yl acetate cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  [1R-(1α,2α,5β,8β)]-4,4,8-trimethyltricyclo [6.3.1.02,5]dodecan-1-yl acetate (CAS no: 57082-24-3) has very low vapour pressure (0.00036 mmHg), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) of [1R-(1α,2α,5β,8β)]-4,4,8-trimethyltricyclo [6.3.1.02,5]dodecan-1-yl acetate (CAS no: 57082-24-3) was considered to be >5000 mg/kg bw, based on experimental study conducted by D. L. J. Opdyke (Food and Cosmetics Toxicology, Vol. 12, Pg. 839, 1974), Richard J. Lewis (Sax's Dangerous Properties of Industrial Materials, 12th Edition, 5 Volume Set, 2012) and U.S. National Library of Medicine (ChemIDplus,2017); predicted study based on OECD QSAR toolbox 6103 mg/kg bw and different studies available on structurally similar read across substances [3R-(3α,3aβ,6α,7β,8aα)]-Octahydro-3,6,8,8-tetramethyl-1H-3a,7-methanoazulen-5-yl acetate (CAS no: 77-54-3) >5000 mg/kg bw; and 2-tert-butylcyclohexyl acetate (CAS no: 88-41-5) >5000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, [1R-(1α,2α,5β,8β)]-4,4,8-trimethyltricyclo [6.3.1.02,5]dodecan-1-yl acetate cannot be classified for acute dermal toxicity. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03982ae1-d847-4eaa-9053-f18dac87e823/documents/cfb00efc-fd06-4847-a2a0-5a624b0ed47a_3ef6e987-40f3-46a1-8591-630aac35d84a.html,,,,,, "[1R-(1α,2α,5β,8β)]-4,4,8-trimethyltricyclo[6.3.1.02,5]dodecan-1-yl acetate",57082-24-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03982ae1-d847-4eaa-9053-f18dac87e823/documents/cfb00efc-fd06-4847-a2a0-5a624b0ed47a_3ef6e987-40f3-46a1-8591-630aac35d84a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "[1R-(1α,2α,5β,8β)]-4,4,8-trimethyltricyclo[6.3.1.02,5]dodecan-1-yl acetate",57082-24-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03982ae1-d847-4eaa-9053-f18dac87e823/documents/cfb00efc-fd06-4847-a2a0-5a624b0ed47a_3ef6e987-40f3-46a1-8591-630aac35d84a.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,6,10-trimethylundec-9-enal",141-13-9,"Repeated dose toxicity: via oral route: NOAEL = 1000 mg/kg bw/day (OECD 422, GLP, K, Rel.1)   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a876f5f8-f223-4638-b93a-2cbf25850657/documents/ff1e2c6f-edc9-44a8-b163-2c51af78f040_96406b4e-5f21-41ab-a72c-6a7023200302.html,,,,,, "2,6,10-trimethylundec-9-enal",141-13-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a876f5f8-f223-4638-b93a-2cbf25850657/documents/ff1e2c6f-edc9-44a8-b163-2c51af78f040_96406b4e-5f21-41ab-a72c-6a7023200302.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,6,10-trimethylundec-9-enal",141-13-9,"Acute toxicity via Oral route: LD50 > 5mL/kg bw (> 4278 mg/kg bw) (eq. OECD 401, non-GLP, K, Rel.2). Acute toxicity via Dermal route: No study available. Acute toxicity via Inhalation route: No study available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a876f5f8-f223-4638-b93a-2cbf25850657/documents/IUC5-f0cc0b66-ae01-4df5-952b-58bea06856ac_96406b4e-5f21-41ab-a72c-6a7023200302.html,,,,,, "2,6,10-trimethylundec-9-enal",141-13-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a876f5f8-f223-4638-b93a-2cbf25850657/documents/IUC5-f0cc0b66-ae01-4df5-952b-58bea06856ac_96406b4e-5f21-41ab-a72c-6a7023200302.html,,oral,LD50,"> 4,278 mg/kg bw",no adverse effect observed, Glycerol trimyristate,555-45-3, Oral: LD50 > 5000 mg/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18752c87-8b62-495e-9c04-ae88a7f1463f/documents/2f651a96-8081-4b44-a438-32514bc352a5_06a92394-4fdf-46ef-a3c8-9190aa65b8ab.html,,,,,, "1,2,3-propanetriyl trioleate",122-32-7,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72008544-3ef6-4d35-b0a8-fd7357b38b27/documents/IUC5-1c606c20-a1fb-4226-9f0b-ac93b00d0646_3bb49787-f816-4767-b02e-02f57231730a.html,,,,,, "1,2,3-propanetriyl trioleate",122-32-7,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72008544-3ef6-4d35-b0a8-fd7357b38b27/documents/IUC5-0f60fb4d-674b-41b2-b2c6-5e0c85bedd79_3bb49787-f816-4767-b02e-02f57231730a.html,,,,,, "2,2'-[oxybis(2,1-ethanediyloxy)]bisacetic acid",13887-98-4, The acute oral LD50 value was found to be >2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01be0880-2e2a-4e2e-95a2-6a5f4c976f2f/documents/906ee8de-88e6-439f-8463-3c03043bfcf5_1d810993-76e8-4dcd-8abb-78d22ce3eca1.html,,,,,, "2,2'-[oxybis(2,1-ethanediyloxy)]bisacetic acid",13887-98-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01be0880-2e2a-4e2e-95a2-6a5f4c976f2f/documents/906ee8de-88e6-439f-8463-3c03043bfcf5_1d810993-76e8-4dcd-8abb-78d22ce3eca1.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Propane-1,2,3-triyl trinonan-1-oate",126-53-4,A NOAEL of 1000 mg/kg bw/d was determined for the test item (read-across on a similar substance) based on effects observed in a combined repeated dose / reprotox screening test (OECD422). A NOAEL of 13200 mg/kg bw/d was determined for the test item (read-across on a similar substance) based on effects observed in a Repeated Dose 90-Day oral toxicity study (OECD408). ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5f57e52-8f6f-4c14-b66d-ca52eef1de9f/documents/e6aa95e8-03a5-4897-b1c8-642f03da83af_7d9e1d4c-83be-45ae-8682-e460ffa36416.html,,,,,, "Propane-1,2,3-triyl trinonan-1-oate",126-53-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5f57e52-8f6f-4c14-b66d-ca52eef1de9f/documents/e6aa95e8-03a5-4897-b1c8-642f03da83af_7d9e1d4c-83be-45ae-8682-e460ffa36416.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Propane-1,2,3-triyl trinonan-1-oate",126-53-4," Two recent GLP studies have been performed on a similar substance according to OECD guidelines for acute oral and dermal toxicity (Salvador, 2014 and 2014a). Both studies did not show any adverse effects up to a concentration of 2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5f57e52-8f6f-4c14-b66d-ca52eef1de9f/documents/e6443c80-5c1b-44e5-82ad-dac05d2c4038_7d9e1d4c-83be-45ae-8682-e460ffa36416.html,,,,,, "Propane-1,2,3-triyl trinonan-1-oate",126-53-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5f57e52-8f6f-4c14-b66d-ca52eef1de9f/documents/e6443c80-5c1b-44e5-82ad-dac05d2c4038_7d9e1d4c-83be-45ae-8682-e460ffa36416.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Propane-1,2,3-triyl trinonan-1-oate",126-53-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5f57e52-8f6f-4c14-b66d-ca52eef1de9f/documents/e6443c80-5c1b-44e5-82ad-dac05d2c4038_7d9e1d4c-83be-45ae-8682-e460ffa36416.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Triphenyl phosphate,115-86-6,"The NOAEL for repeated dose toxicity of triphenyl phosphate in male and female rats can be determined with 105 mg/kg bw/d, the lowest NOAEL obtained in the recently performed Guideline study with subchronic exposure. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b2f054a-c82b-4cc1-9393-415a4f7781c1/documents/3d9c9ea3-7511-4632-a0b9-c93efc0139a5_8c1aeebd-fd78-4661-8347-2e35a628af30.html,,,,,, Triphenyl phosphate,115-86-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b2f054a-c82b-4cc1-9393-415a4f7781c1/documents/3d9c9ea3-7511-4632-a0b9-c93efc0139a5_8c1aeebd-fd78-4661-8347-2e35a628af30.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rabbit Triphenyl phosphate,115-86-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b2f054a-c82b-4cc1-9393-415a4f7781c1/documents/3d9c9ea3-7511-4632-a0b9-c93efc0139a5_8c1aeebd-fd78-4661-8347-2e35a628af30.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,105 mg/kg bw/day,,rat Triphenyl phosphate,115-86-6,"Acute toxicity after oral and dermal administration of triphenyl phosphate is very low. Acute oraladministration in rats, mice, rabbits and guinea pigs produced LD50 values in a range of 3000 mg/kgbody weight to above 20000 mg/kg body weight. After dermal application an LD50 >7900 mg/kg bodyweight was established in rabbits. No valid studies are available regarding inhalation exposure to TPP.A number of studies are available using other routes of exposure such as subcutaneous, intraperitonealand intramuscular injections which confirm the low level acute toxicity of triphenyl phosphate. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b2f054a-c82b-4cc1-9393-415a4f7781c1/documents/2a888120-25bd-4345-bd50-ba8a00da2ee2_8c1aeebd-fd78-4661-8347-2e35a628af30.html,,,,,, Triphenyl phosphate,115-86-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b2f054a-c82b-4cc1-9393-415a4f7781c1/documents/2a888120-25bd-4345-bd50-ba8a00da2ee2_8c1aeebd-fd78-4661-8347-2e35a628af30.html,,oral,LD50,"3,000 mg/kg bw",, Triphenyl phosphate,115-86-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b2f054a-c82b-4cc1-9393-415a4f7781c1/documents/2a888120-25bd-4345-bd50-ba8a00da2ee2_8c1aeebd-fd78-4661-8347-2e35a628af30.html,,dermal,LD50,"7,900 mg/kg bw",, Triphenylphosphine,603-35-0," Repeated oral toxicity: Experimental test data from several species are available, suggesting that rats are relatively insensitive towards the test substance and dogs being the most sensitive species. Under the conditions of a 90-day combined Repeated Dose Toxicity Study with a Neurotoxicity study, the oral administration of the test item in an aqueous vehicle by gavage to Wistar rats revealed adverse findings at 60 mg/kg bw/d regarding organ weights and clinical biochemistry endpoints. Thus, the no observed adverse effect level (NOAEL) for general systemic toxicity was 6 mg/kg bw/d [BASF, 2002]. Oral Application of the test substance suspended in an oily vehicle over 28 days caused clinical signs of neurotoxicity in rabbits with a NOAEL of <100 mg/kg bw/d [BASF, 1973] and dogs with a NOAEL of 1 mg/kg bw/d [M&T Chemicals, 1983], which were accompanied with axonal degeneration in the dog study (LOAEL 5 mg/kg bw/d). Repeated inhalation toxicity: Experimental test data from several species are available, suggesting that rats are relatively insensitive towards the test substance and dogs beeing the most sensitive species. An aerosol of the test substance in xylol produced signs of neurological impairment at 28 mg/m3 in a 4-wk inhalation study in dogs which correlated with neurotoxic tissue effects (NOAEC 10 mg/m3) [M&T Chemicals, 1983]. An aerosol of approximately 2400 mg/m3 generated by nebulizing the molten test substance, however, didn’t produce neurotoxic effects in rats during a 12-day exposure but led to clinical signs of mild respiratory irritation like salivation, lacrimation, dyspnea and red ears [Waritz, 1975]. Repeated dermal toxicity: No data available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69e78720-6178-41df-b51c-4cdb0eaa0421/documents/IUC5-8b00ebd1-b95d-467c-9843-e86bb7c5964f_d2d9ea39-e279-42c4-b5dc-c1e90b98fc09.html,,,,,, Triphenylphosphine,603-35-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69e78720-6178-41df-b51c-4cdb0eaa0421/documents/IUC5-8b00ebd1-b95d-467c-9843-e86bb7c5964f_d2d9ea39-e279-42c4-b5dc-c1e90b98fc09.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,1 mg/kg bw/day,,dog Triphenylphosphine,603-35-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69e78720-6178-41df-b51c-4cdb0eaa0421/documents/IUC5-8b00ebd1-b95d-467c-9843-e86bb7c5964f_d2d9ea39-e279-42c4-b5dc-c1e90b98fc09.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,10 mg/m3,,dog Triphenylphosphine,603-35-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69e78720-6178-41df-b51c-4cdb0eaa0421/documents/IUC5-8b00ebd1-b95d-467c-9843-e86bb7c5964f_d2d9ea39-e279-42c4-b5dc-c1e90b98fc09.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"2,400 mg/m3",adverse effect observed, Triphenylphosphine,603-35-0," Based on key study results, the oral LD50 of the test material in rats is 700 mg/kg bw (BASF SE, 1952), the inhalation LC50 (4 hours) in rats is 12.5 mg/L (Waritz, 1975) and the dermal LD50 in rabbits is >4000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69e78720-6178-41df-b51c-4cdb0eaa0421/documents/IUC5-f06ce068-eaa2-42f2-b634-4af0ecb7d274_d2d9ea39-e279-42c4-b5dc-c1e90b98fc09.html,,,,,, Triphenylphosphine,603-35-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69e78720-6178-41df-b51c-4cdb0eaa0421/documents/IUC5-f06ce068-eaa2-42f2-b634-4af0ecb7d274_d2d9ea39-e279-42c4-b5dc-c1e90b98fc09.html,,oral,LD50,700 mg/kg bw,adverse effect observed, Triphenylphosphine,603-35-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69e78720-6178-41df-b51c-4cdb0eaa0421/documents/IUC5-f06ce068-eaa2-42f2-b634-4af0ecb7d274_d2d9ea39-e279-42c4-b5dc-c1e90b98fc09.html,,dermal,LD50,"4,000 mg/kg bw",no adverse effect observed, Triphenylphosphine,603-35-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69e78720-6178-41df-b51c-4cdb0eaa0421/documents/IUC5-f06ce068-eaa2-42f2-b634-4af0ecb7d274_d2d9ea39-e279-42c4-b5dc-c1e90b98fc09.html,,inhalation,LC50,"12,500 mg/m3",adverse effect observed, Tripotassium hydrogen ethylenediaminetetraacetate,17572-97-3," The following oral key studies were evaluated for the determination of DNEL values: Study I: In the present subchronic toxicity study on rats, a NOAEL of 1670 mg/kg bw /day for Na2H2EDTA was found. Study II: Two-year feeding studies in rats showed no significant deviations from normal physiological responses nor any evidence of interference with mineral metabolism at levels of calcium EDTA up to 250 mg per kilogram body weight. Study III: In a 1-year study with dogs no treatment-related changes occured up to and including the high dose level of 250 mg/kg bw (nominal) or 338 mg/kg bw (actual intake). A study according to OECD 410 (sub-acute 28 days, dermal) on CDTA revealed no toxic effects up to a dose of 800 mg/kg bw. All other repeated dose or reproductive toxicity studies were consideres as less reliable (weight of evidence or supporting study) and thus less relevant for the DNEL derivation. The lowest NO(A)EL being found was 250 mg/kg bw. Based on the results of the studies and according to the classification of similar soluble EDTA salts (e.g. EDTA-K2, EDTA-Na2) it is justified to classify as STOT RE 2 (H373). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/02770468-e453-4c7c-9527-9223940e11b2/documents/f4704b78-614c-4452-9f19-40c23c5f438b_94823a56-4647-46d0-817f-f89b2d672860.html,,,,,, Tripotassium hydrogen ethylenediaminetetraacetate,17572-97-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/02770468-e453-4c7c-9527-9223940e11b2/documents/f4704b78-614c-4452-9f19-40c23c5f438b_94823a56-4647-46d0-817f-f89b2d672860.html,Chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Tripotassium hydrogen ethylenediaminetetraacetate,17572-97-3, The acute oral LD50 of K3EDTA is 2800 mg/kg bw as determined by read-across. Dermal exposure is unlikely thus no study was performed. The acute inhalative LD50 of K3EDTA is > 1000 mg/m³ as determined by read-across. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02770468-e453-4c7c-9527-9223940e11b2/documents/e724bd6a-9609-4f18-b7e4-741e94d69c14_94823a56-4647-46d0-817f-f89b2d672860.html,,,,,, Tripotassium hydrogen ethylenediaminetetraacetate,17572-97-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02770468-e453-4c7c-9527-9223940e11b2/documents/e724bd6a-9609-4f18-b7e4-741e94d69c14_94823a56-4647-46d0-817f-f89b2d672860.html,,oral,LD50,"2,800 mg/kg bw",no adverse effect observed, Tripotassium hydrogen ethylenediaminetetraacetate,17572-97-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02770468-e453-4c7c-9527-9223940e11b2/documents/e724bd6a-9609-4f18-b7e4-741e94d69c14_94823a56-4647-46d0-817f-f89b2d672860.html,,inhalation,LC50,"1,103 mg/m3",adverse effect observed, Tripotassium orthophosphate,7778-53-2,"The key information has been provided on the analogous substance sodium aluminium phosphate. The key study (Matalski K, 1972b) has been selected as the most reliable or appropriate study for use in the derivation of DNELS. In addition a reliable 28 day study (OECD 422) exists for the analogous substance dipotassium hydrogenorthophosphate (Shim, 2005), however as the study is only a 28-day study and in accordance with Annex XI, Section 3.2 (a.ii) of Regulation (EC) No. 1907/2006 (REACH) the data are not considered to be suitable for derivation of a DNEL as subchronic data are available. Additional supporting data are not considered to fulfil the guideline requirements for repeated dose toxicity (sub-chronic or chronic). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0139b92-9785-47d3-8222-49ff46144058/documents/IUC5-9ba1eb2d-6267-460e-b631-6fa11f4b4202_1390581e-12b1-4764-917f-143dbf399f60.html,,,,,, Tripotassium orthophosphate,7778-53-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0139b92-9785-47d3-8222-49ff46144058/documents/IUC5-9ba1eb2d-6267-460e-b631-6fa11f4b4202_1390581e-12b1-4764-917f-143dbf399f60.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,323 mg/kg bw/day,,dog Tripotassium orthophosphate,7778-53-2,"Three studies are available to assess the acute oral toxicity of tripotassium orthophosphate. All studies indicate that tripotassium orthophosphate has a low potential for systemic toxicity following acute administration via the oral route. A weight of evidence approach has been implemented to reduce unnecessary animal testing. The LD50 of tripotassium orthophosphate is known to be > 2,000 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP).  ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0139b92-9785-47d3-8222-49ff46144058/documents/IUC5-1f75ab90-e2cd-4845-ad19-addae268b013_1390581e-12b1-4764-917f-143dbf399f60.html,,,,,, Tripotassium orthophosphate,7778-53-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0139b92-9785-47d3-8222-49ff46144058/documents/IUC5-1f75ab90-e2cd-4845-ad19-addae268b013_1390581e-12b1-4764-917f-143dbf399f60.html,,oral,LD50,"4,260 mg/kg bw",no adverse effect observed, Tripotassium orthophosphate,7778-53-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0139b92-9785-47d3-8222-49ff46144058/documents/IUC5-1f75ab90-e2cd-4845-ad19-addae268b013_1390581e-12b1-4764-917f-143dbf399f60.html,,dermal,LD50,"4,640 mg/kg bw",no adverse effect observed, [(methylethylene)bis(oxy)]dipropanol,24800-44-0,"A combined repeated dose toxicity study with the reproduction / developmental toxicity screening test with rats exposed to tripropylene glycol by gavage resulted in NOAEL of 200 mg/kg bw/day, based on increased relative liver weights in male and female rats and increased relative kidney weights in male rats. Based on read-across from a structural analogue of tripropylene glycol, dipropylene glycol, a long-term NOAEL of 673 mg/kg bw'day has been derived and shall be used for the risk assessment. No studies using inhalation or dermal routes of exposure were recovered, therefore route-to-route extrapolation shall be used to derive DNELs for these endpoints. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/164aef7b-06b4-48f1-a0f2-76bea4b70b9b/documents/IUC5-1584df21-bdfd-492a-bdb0-4006e7866080_7436ef2b-5de6-4635-87a4-19f7fe4edad7.html,,,,,, [(methylethylene)bis(oxy)]dipropanol,24800-44-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/164aef7b-06b4-48f1-a0f2-76bea4b70b9b/documents/IUC5-1584df21-bdfd-492a-bdb0-4006e7866080_7436ef2b-5de6-4635-87a4-19f7fe4edad7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,673 mg/kg bw/day,,rat [(methylethylene)bis(oxy)]dipropanol,24800-44-0,"Acute toxicity of tripropylene glycol is low. In rats, LD50 value by oral route is >2000 mg/kg bw. In the acute dermal toxicity study with rabbits, LD50 was > 16320 mg/kg bw. In the acute inhalation toxicity study with rats, LC50 value was > 0.083 mg/L/8h, which corresponded to saturated vapor concentration of tripropylene glycol at ambient temperature and pressure. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/164aef7b-06b4-48f1-a0f2-76bea4b70b9b/documents/IUC5-8f383446-9358-43b1-82b1-9a436a4f456e_7436ef2b-5de6-4635-87a4-19f7fe4edad7.html,,,,,, [(methylethylene)bis(oxy)]dipropanol,24800-44-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/164aef7b-06b4-48f1-a0f2-76bea4b70b9b/documents/IUC5-8f383446-9358-43b1-82b1-9a436a4f456e_7436ef2b-5de6-4635-87a4-19f7fe4edad7.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, [(methylethylene)bis(oxy)]dipropanol,24800-44-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/164aef7b-06b4-48f1-a0f2-76bea4b70b9b/documents/IUC5-8f383446-9358-43b1-82b1-9a436a4f456e_7436ef2b-5de6-4635-87a4-19f7fe4edad7.html,,dermal,LD50,"16,320 mg/kg bw",no adverse effect observed, [(methylethylene)bis(oxy)]dipropanol,24800-44-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/164aef7b-06b4-48f1-a0f2-76bea4b70b9b/documents/IUC5-8f383446-9358-43b1-82b1-9a436a4f456e_7436ef2b-5de6-4635-87a4-19f7fe4edad7.html,,inhalation,LC50,83 mg/m3,adverse effect observed, "1,3,5-tris[[4-tert-butyl-3-hydroxy-2,6-xylyl]methyl]-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",40601-76-1," Sprague-Dawley rats were used in this study. 20 males and 20 females were assigned to control, and to each of the test groups (25, 100 and 400 mg/kg). The length of the treatment period was 90 days. One animal in the mid-dose group (100 mg/kg) died after 12 days of treatment but was an isolated case and so not related to administration of test material.  Animals were generally healthy during the study, but exhibited alopecia around the nares and paws, diarrhea, watery eyes (animals that were bled, only) and encrustment around the nares. These signs were attributed to ingestion of a powdered food and were not considered to be related to test material.   Food intake was measured weekly, other than a random week where a particular test group ate less food than comparable test groups or control groups, there was no significant difference in food intake between control and test animals in any sex grouping. Animals were weighed initially and then weekly thereafter. Weight gains were essentially comparable in treated and control groups with only a sex difference noted; males gained more weight than females. Gamma-glutamyl transpeptidase (GGTP), glutamix-oxaloacetic transpeptidase, glutamic-pyruvic transaminase and urea were measured at 90 days in 5 males and 5 females from each test group. GGTP values were variable within the different dose groups but were within the values usually observed in this strain of rat. Glucose levels of treated animals were lower than controls but were within the range of normal values reported for this strain of rat. Since there were not statistically significant differences between the means of treated animals, the significant difference between the high-dose females and their control was considered to be a result of some unusually high values among the controls and was not considered to be the result of administering the test material. Glutamic-oxaloacetic transaminase, Glutamic-pyruvic transaminase and urea were unaffected by the treatment. At 45 days, no changes in erythrocyte counts were noted. At 90 days, there was a trend toward increased red blood cells in low and mid-dose animals; however, counts in high dose animals were similar to controls. Since the increase was not dose-related, this observation was thought to be artifactual in nature and not related to administration of test material. There were no changes in hematocrit, hemoglobin, leukocyte count, platelet estimate and erythrocyte morphology. There was no effect of treatment on urinalysis, organ weights, or gross pathology.  One of the males with a high GGTP value had focal perivascular and periductal mononuclear leukocyte infiltration in the liver, but the other animal did not demonstrate any liver pathology.  Livers of other males in the high dose group had histopathology similar to that of controls.  Other mild inflammatory lesions characterized by leukocytic infiltration also occurred in the lungs, liver and kidneys of a few animals in each group.  All changes were considered to be spontaneous and not related to administration of test material. Therefore it is concluded that the test material did not affect adversely the rats after 90 days of administration at the highest dose tested. The NOAEL is 400 mg/kg bw. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09e8edfe-41fd-4299-aada-a63858efaab1/documents/IUC5-c963dd2e-22c5-45bf-b5ff-ed0d0b47dd63_4197510a-f52e-474d-8d0d-be5f654876f0.html,,,,,, "1,3,5-tris[[4-tert-butyl-3-hydroxy-2,6-xylyl]methyl]-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",40601-76-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09e8edfe-41fd-4299-aada-a63858efaab1/documents/IUC5-c963dd2e-22c5-45bf-b5ff-ed0d0b47dd63_4197510a-f52e-474d-8d0d-be5f654876f0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat "1,3,5-tris[[4-tert-butyl-3-hydroxy-2,6-xylyl]methyl]-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",40601-76-1,Recent and well-conducted guideline studies in rats indicate no significant toxicity up to limiting doses of 2000 mg/kg bw either by the oral or dermal routes of exposure. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09e8edfe-41fd-4299-aada-a63858efaab1/documents/IUC5-f8e208e6-9f93-4efd-8b89-f0025a3a382a_4197510a-f52e-474d-8d0d-be5f654876f0.html,,,,,, "1,3,5-tris[[4-tert-butyl-3-hydroxy-2,6-xylyl]methyl]-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",40601-76-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09e8edfe-41fd-4299-aada-a63858efaab1/documents/IUC5-f8e208e6-9f93-4efd-8b89-f0025a3a382a_4197510a-f52e-474d-8d0d-be5f654876f0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3,5-tris[[4-tert-butyl-3-hydroxy-2,6-xylyl]methyl]-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",40601-76-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09e8edfe-41fd-4299-aada-a63858efaab1/documents/IUC5-f8e208e6-9f93-4efd-8b89-f0025a3a382a_4197510a-f52e-474d-8d0d-be5f654876f0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,4-dihydroxy-2,2,6,6-tetramethyl piperidinium-2-hydroxy-1,2,3-propanetricarboxylate",220410-74-2,"NOAEL oral (rat, 28 d) = 100 mg/kg/d (OECD 407; Springborn Laboratories, 1999)NOAEL dermal (90 d, rat) = 150 mg/kg/d (OECD 411, CIT, 2010) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03842c2c-7a64-4cdb-992a-3bd69ab22ec0/documents/IUC5-a8f1b7cb-cb05-4557-80f2-fe876c99f75c_3f04b3e9-c423-49af-9ff8-8ef253656a16.html,,,,,, "1,4-dihydroxy-2,2,6,6-tetramethyl piperidinium-2-hydroxy-1,2,3-propanetricarboxylate",220410-74-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03842c2c-7a64-4cdb-992a-3bd69ab22ec0/documents/IUC5-a8f1b7cb-cb05-4557-80f2-fe876c99f75c_3f04b3e9-c423-49af-9ff8-8ef253656a16.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1,4-dihydroxy-2,2,6,6-tetramethyl piperidinium-2-hydroxy-1,2,3-propanetricarboxylate",220410-74-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03842c2c-7a64-4cdb-992a-3bd69ab22ec0/documents/IUC5-a8f1b7cb-cb05-4557-80f2-fe876c99f75c_3f04b3e9-c423-49af-9ff8-8ef253656a16.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,150 mg/kg bw/day,,rat "1,4-dihydroxy-2,2,6,6-tetramethyl piperidinium-2-hydroxy-1,2,3-propanetricarboxylate",220410-74-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03842c2c-7a64-4cdb-992a-3bd69ab22ec0/documents/IUC5-a8f1b7cb-cb05-4557-80f2-fe876c99f75c_3f04b3e9-c423-49af-9ff8-8ef253656a16.html,Repeated dose toxicity – local effects,dermal,NOAEL,150 ,adverse effect observed,rat "1,4-dihydroxy-2,2,6,6-tetramethyl piperidinium-2-hydroxy-1,2,3-propanetricarboxylate",220410-74-2,The test item was tested for acute oral toxicity in a GLP study according to OECD 401 on oral gavage in rats. The LD50 was determined to be 1758 mg/kg bw rats.The test item was tested for acute inhalation toxicity in a GLP study according to OECD 403 in rats. The LC50 was determined to be greater than 5080 mg/m³ in rats.The test item was tested for acute dermal toxicity in a GLP and guideline study according to OECD 402 on dermal administration in rats. The LD50 was determined to be greater than 2000 mg/kg bw in male and female rabbits. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03842c2c-7a64-4cdb-992a-3bd69ab22ec0/documents/IUC5-8de9ea21-5a57-4543-9aab-3f1f4632fcf7_3f04b3e9-c423-49af-9ff8-8ef253656a16.html,,,,,, "1,4-dihydroxy-2,2,6,6-tetramethyl piperidinium-2-hydroxy-1,2,3-propanetricarboxylate",220410-74-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03842c2c-7a64-4cdb-992a-3bd69ab22ec0/documents/IUC5-8de9ea21-5a57-4543-9aab-3f1f4632fcf7_3f04b3e9-c423-49af-9ff8-8ef253656a16.html,,oral,LD50,"1,757.8 mg/kg bw",adverse effect observed, "1,4-dihydroxy-2,2,6,6-tetramethyl piperidinium-2-hydroxy-1,2,3-propanetricarboxylate",220410-74-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03842c2c-7a64-4cdb-992a-3bd69ab22ec0/documents/IUC5-8de9ea21-5a57-4543-9aab-3f1f4632fcf7_3f04b3e9-c423-49af-9ff8-8ef253656a16.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,4-dihydroxy-2,2,6,6-tetramethyl piperidinium-2-hydroxy-1,2,3-propanetricarboxylate",220410-74-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03842c2c-7a64-4cdb-992a-3bd69ab22ec0/documents/IUC5-8de9ea21-5a57-4543-9aab-3f1f4632fcf7_3f04b3e9-c423-49af-9ff8-8ef253656a16.html,,inhalation,discriminating conc.,"5,080 mg/m3",no adverse effect observed, "3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol",1709-70-2,"Study not performed to a specified method, however study written with a clear and concise study plan.A dietary concentration of 10,000 ppm did not produce any toxicological effects when fed to dogs for two years. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92707fe6-b0b8-465b-a5e4-a2c94811fd87/documents/IUC5-1ce41f05-e01f-420f-b568-af0279552734_860245a2-d5ca-4f68-9779-8bebcb2c3b9d.html,,,,,, "3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol",1709-70-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92707fe6-b0b8-465b-a5e4-a2c94811fd87/documents/IUC5-1ce41f05-e01f-420f-b568-af0279552734_860245a2-d5ca-4f68-9779-8bebcb2c3b9d.html,Chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,dog "3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol",1709-70-2,"Effect level for the dermal route determined using OECD method 402. LD50 > 2000 mg/kg bwEffect level for the oral route not determined to a specified method, however study written with clear and consice study plan. LD50 >10000 mg/kg/bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92707fe6-b0b8-465b-a5e4-a2c94811fd87/documents/IUC5-0b313e6a-1f57-4157-a8c6-aedc314fe6bc_860245a2-d5ca-4f68-9779-8bebcb2c3b9d.html,,,,,, "3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol",1709-70-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92707fe6-b0b8-465b-a5e4-a2c94811fd87/documents/IUC5-0b313e6a-1f57-4157-a8c6-aedc314fe6bc_860245a2-d5ca-4f68-9779-8bebcb2c3b9d.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "3,3',3'',5,5',5''-hexa-tert-butyl-α,α',α''-(mesitylene-2,4,6-triyl)tri-p-cresol",1709-70-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92707fe6-b0b8-465b-a5e4-a2c94811fd87/documents/IUC5-0b313e6a-1f57-4157-a8c6-aedc314fe6bc_860245a2-d5ca-4f68-9779-8bebcb2c3b9d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,4,6-Tris([1,1'-biphenyl]-4-yl) -1,3,5-triazine",31274-51-8," In a 90-day repeated dose toxicity test (comparable to OECD TG 408, acc. to GLP) by oral gavage in male and female Sprague Dawley rats no toxicity occurred up to the limit dose of 1000 mg/kg bw/day ETH50. The NOAEL was determined to be 1000 mg/kg bw/day. In a 90-day dermal repeated dose toxicity test (according to OECD TG 411) in male and female Wistar rats no adverse test substance related effects were noted up to the limit dose of 1000 mg/kg bw/day ETH50. The NOAEL was determined to be 1000 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/130c4a1d-3202-4240-b402-facaf410ec4a/documents/5d15fc74-9e1a-4606-9317-d2f3db0c95ec_a63bb0fa-96df-4633-b80c-375c2367f26d.html,,,,,, "2,4,6-Tris([1,1'-biphenyl]-4-yl) -1,3,5-triazine",31274-51-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/130c4a1d-3202-4240-b402-facaf410ec4a/documents/5d15fc74-9e1a-4606-9317-d2f3db0c95ec_a63bb0fa-96df-4633-b80c-375c2367f26d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,4,6-Tris([1,1'-biphenyl]-4-yl) -1,3,5-triazine",31274-51-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/130c4a1d-3202-4240-b402-facaf410ec4a/documents/5d15fc74-9e1a-4606-9317-d2f3db0c95ec_a63bb0fa-96df-4633-b80c-375c2367f26d.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "2,4,6-Tris([1,1'-biphenyl]-4-yl) -1,3,5-triazine",31274-51-8,Oral: The acute oral LD50 was determined to be > 2000 mg/kg bw in rats. Dermal: The acute dermal LD50 was determined to be > 2000 mg/kg bw in rats. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/130c4a1d-3202-4240-b402-facaf410ec4a/documents/971eccfd-0938-40f5-8004-499a64baf47b_a63bb0fa-96df-4633-b80c-375c2367f26d.html,,,,,, "2,4,6-Tris([1,1'-biphenyl]-4-yl) -1,3,5-triazine",31274-51-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/130c4a1d-3202-4240-b402-facaf410ec4a/documents/971eccfd-0938-40f5-8004-499a64baf47b_a63bb0fa-96df-4633-b80c-375c2367f26d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,4,6-Tris([1,1'-biphenyl]-4-yl) -1,3,5-triazine",31274-51-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/130c4a1d-3202-4240-b402-facaf410ec4a/documents/971eccfd-0938-40f5-8004-499a64baf47b_a63bb0fa-96df-4633-b80c-375c2367f26d.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)-triyl)tri-2,1-ethanediyl triacrylate",40220-08-4,"In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in rat performed according to OECD TG 422 and  in accordance with GLP principles, the NOAEL parental for Tris(2-hydroxyethyl) Isocyanurate Triacrylate was considered to be 50 mg/kg bw/day based on the lesions in the forestomach which were adverse from 100 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/172a9dcb-83c6-4915-a86e-19e6bac45f5c/documents/768854c6-1e17-4e2c-b903-cd8dfd364e5b_2037c632-936d-49db-897b-deaee037efce.html,,,,,, "(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)-triyl)tri-2,1-ethanediyl triacrylate",40220-08-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/172a9dcb-83c6-4915-a86e-19e6bac45f5c/documents/768854c6-1e17-4e2c-b903-cd8dfd364e5b_2037c632-936d-49db-897b-deaee037efce.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)-triyl)tri-2,1-ethanediyl triacrylate",40220-08-4,An oral acute toxicity study is available on Tris(2-hydroxyethyl) isocyanurate triacrylate and showed no mortality at the highest tested dose of 2000 mg/kg in rats. No acute experimental data is available by dermal and inhalation route. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/172a9dcb-83c6-4915-a86e-19e6bac45f5c/documents/b97995c2-6741-4e33-8ce3-d0b4868f97cb_2037c632-936d-49db-897b-deaee037efce.html,,,,,, "(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)-triyl)tri-2,1-ethanediyl triacrylate",40220-08-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/172a9dcb-83c6-4915-a86e-19e6bac45f5c/documents/b97995c2-6741-4e33-8ce3-d0b4868f97cb_2037c632-936d-49db-897b-deaee037efce.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Octamethyltrisiloxane,107-51-7," Whole body exposure of SD rats to octamethyltrisiloxane at 95, 400 or 3200 ppm for 90 days resulted in liver and kidney changes (Harlan, 2011). In the liver hepatocyte hypertrophy and accumulation of brown pigment in the bile ducts with associated periportal inflammation and bile duct proliferation were noted. In the kidneys tubular hypertrophy was noted and associated with minor changes in salt balance and plasma protein levels. Hyaline droplets noted represented alpha-2u-globulin accumulation. Based on the secondary effects of pigment accumulation noted in the liver at 3200 ppm the NOAEC was considered to be 400 ppm. There were no local effects. In an OECD Guideline 422 study (Dow Corning Corporation, 2008), performed to GLP, the potential inhalation toxicity of octamethyltrisiloxane was evaluated in Sprague-Dawley rats. Animals were exposed to target concentrations of 0, 800, 1600 or 3200 ppm for 6 hours/day for 29 days in the toxicity test and up to 42 days in the reproductive/developmental screening test. After 29 days, there were no overt toxic effects. Increased liver weights were observed in female rats exposed to 806 ppm and above and in male rats exposed to 3146 ppm. Histopathological examination revealed effects that were attributed to octamethyltrisiloxane exposure in the liver, kidney and thyroid gland. Effects (centrilobular hypertrophy) in the liver were evident in females at all dose levels and in males in the highest exposure group. In males, hepatic brown pigment accumulation was observed in the mid- and high exposure groups and protein droplet nephropathy at 806 ppm and above. Thyroid gland follicular hypertrophy was evident in both sexes at 3146 ppm and this was considered to be secondary to the hepatic centrilobular hypertrophy. Actual exposure concentrations were 806, 1623 and 3146 ppm. The NOAEC for general systemic toxicity was <806 ppm octamethyltrisiloxane based on protein droplet nephropathy and hepatic brown pigment accumulation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d25789c4-2361-4fa4-8c14-1a1d7467dc6d/documents/69a34f36-8b98-420b-87c0-c22458c9d9fc_325b6c1c-eb27-4004-bbd6-897b50c11126.html,,,,,, Octamethyltrisiloxane,107-51-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d25789c4-2361-4fa4-8c14-1a1d7467dc6d/documents/69a34f36-8b98-420b-87c0-c22458c9d9fc_325b6c1c-eb27-4004-bbd6-897b50c11126.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Octamethyltrisiloxane,107-51-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d25789c4-2361-4fa4-8c14-1a1d7467dc6d/documents/69a34f36-8b98-420b-87c0-c22458c9d9fc_325b6c1c-eb27-4004-bbd6-897b50c11126.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"3,870 mg/m3",,rat Octamethyltrisiloxane,107-51-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d25789c4-2361-4fa4-8c14-1a1d7467dc6d/documents/69a34f36-8b98-420b-87c0-c22458c9d9fc_325b6c1c-eb27-4004-bbd6-897b50c11126.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"30,690 mg/m3",no adverse effect observed,rat Octamethyltrisiloxane,107-51-7," The key study for acute oral toxicity determined an LD50value of >2000 mg/kg in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP (Dow Corning 2004).   The key study for acute inhalation toxicity exposed rats to a test atmosphere of vapour and determined an LC50value of >22.6 mg/l (analytical) in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP (Dow Corning 2004). The key study for acute dermal toxicity determined an LD50value of >2000 mg/kg in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP (Dow Corning 2009). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d25789c4-2361-4fa4-8c14-1a1d7467dc6d/documents/2a83402e-240a-4266-87dd-81468833daf8_325b6c1c-eb27-4004-bbd6-897b50c11126.html,,,,,, Octamethyltrisiloxane,107-51-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d25789c4-2361-4fa4-8c14-1a1d7467dc6d/documents/2a83402e-240a-4266-87dd-81468833daf8_325b6c1c-eb27-4004-bbd6-897b50c11126.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Octamethyltrisiloxane,107-51-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d25789c4-2361-4fa4-8c14-1a1d7467dc6d/documents/2a83402e-240a-4266-87dd-81468833daf8_325b6c1c-eb27-4004-bbd6-897b50c11126.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Octamethyltrisiloxane,107-51-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d25789c4-2361-4fa4-8c14-1a1d7467dc6d/documents/2a83402e-240a-4266-87dd-81468833daf8_325b6c1c-eb27-4004-bbd6-897b50c11126.html,,inhalation,LC50,22.6 mg/m3,no adverse effect observed, Trisodium 2-[bis(carboxylatomethyl)amino]propanoate,164462-16-2,- Chronic toxicity (oral): 262.2/333.9 mg/kg bw/d for m/f; rat; according to OECD TG 453; GLP; K1 - Subchronic toxicity (oral): 170/1056 mg/kg bw/d for m/f; rat; according to OECD TG 408; GLP; K1 - Subacute toxicity (oral): 76/88 mg/kg bw/d for m/f; rat; according to OECD TG 407; GLP; K2   The kidney was determined to be target organ. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7558073-145b-4cc3-bc25-ac8ad4669ac5/documents/IUC5-8b30780a-bae0-408c-9550-c84b2bf00668_074c5da4-85a9-48ea-b30b-b6dd3f15d71a.html,,,,,, Trisodium 2-[bis(carboxylatomethyl)amino]propanoate,164462-16-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7558073-145b-4cc3-bc25-ac8ad4669ac5/documents/IUC5-8b30780a-bae0-408c-9550-c84b2bf00668_074c5da4-85a9-48ea-b30b-b6dd3f15d71a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,76 mg/kg bw/day,,rat Trisodium 2-[bis(carboxylatomethyl)amino]propanoate,164462-16-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7558073-145b-4cc3-bc25-ac8ad4669ac5/documents/IUC5-8b30780a-bae0-408c-9550-c84b2bf00668_074c5da4-85a9-48ea-b30b-b6dd3f15d71a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,170 mg/kg bw/day,,rat Trisodium 2-[bis(carboxylatomethyl)amino]propanoate,164462-16-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7558073-145b-4cc3-bc25-ac8ad4669ac5/documents/IUC5-8b30780a-bae0-408c-9550-c84b2bf00668_074c5da4-85a9-48ea-b30b-b6dd3f15d71a.html,Chronic toxicity – systemic effects,oral,NOAEL,262.2 mg/kg bw/day,,rat Trisodium 2-[bis(carboxylatomethyl)amino]propanoate,164462-16-2,"- Oral: according to EU Method B.1 (limit test) and GLP, rat, LD50 >2000 mg/kg bw - Dermal: according to OECD TG 402 (limit test) and GLP, rat, semi-occlusive dressing (24h) with washing, LD50 >2000 mg/kg bw - Inhalation (Read-across): no guideline followed and pre-GLP, rat, 4 h exposure to aerosol, 14 days observation period, LC0 = 5 mg/L ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7558073-145b-4cc3-bc25-ac8ad4669ac5/documents/IUC5-8c3ad989-cbe5-4911-9a43-e3cc956a6479_074c5da4-85a9-48ea-b30b-b6dd3f15d71a.html,,,,,, Trisodium 2-[bis(carboxylatomethyl)amino]propanoate,164462-16-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7558073-145b-4cc3-bc25-ac8ad4669ac5/documents/IUC5-8c3ad989-cbe5-4911-9a43-e3cc956a6479_074c5da4-85a9-48ea-b30b-b6dd3f15d71a.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Trisodium 2-[bis(carboxylatomethyl)amino]propanoate,164462-16-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7558073-145b-4cc3-bc25-ac8ad4669ac5/documents/IUC5-8c3ad989-cbe5-4911-9a43-e3cc956a6479_074c5da4-85a9-48ea-b30b-b6dd3f15d71a.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Trisodium 2-[bis(carboxylatomethyl)amino]propanoate,164462-16-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7558073-145b-4cc3-bc25-ac8ad4669ac5/documents/IUC5-8c3ad989-cbe5-4911-9a43-e3cc956a6479_074c5da4-85a9-48ea-b30b-b6dd3f15d71a.html,,inhalation,discriminating conc.,5 mg/L,no adverse effect observed, Trisodium hydrogen ethylenediaminetetraacetate,150-38-9," subchronic toxicity: oral, 90 day, rat (no guideline followed): NOAEL: 500 mg/kg bw/day inhalation, 90 days (65 exposures), rat (OECD 413): NOAEC: 3 mg/m3 (local effects), NOAEC >= 15 mg/m3 (systemic effects) Read across from disodium dihydrogen EDTA (CAS 139-33-3) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dcb2e6b-1b76-4842-9619-c6684bda9ec8/documents/c6a311d6-92e0-4549-8ac4-54c47dcd977c_35585371-f1ad-4222-b9ad-d94146e8ffe1.html,,,,,, Trisodium hydrogen ethylenediaminetetraacetate,150-38-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dcb2e6b-1b76-4842-9619-c6684bda9ec8/documents/c6a311d6-92e0-4549-8ac4-54c47dcd977c_35585371-f1ad-4222-b9ad-d94146e8ffe1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Trisodium hydrogen ethylenediaminetetraacetate,150-38-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dcb2e6b-1b76-4842-9619-c6684bda9ec8/documents/c6a311d6-92e0-4549-8ac4-54c47dcd977c_35585371-f1ad-4222-b9ad-d94146e8ffe1.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,15 mg/m3,,rat Trisodium hydrogen ethylenediaminetetraacetate,150-38-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dcb2e6b-1b76-4842-9619-c6684bda9ec8/documents/c6a311d6-92e0-4549-8ac4-54c47dcd977c_35585371-f1ad-4222-b9ad-d94146e8ffe1.html,Repeated dose toxicity – local effects,inhalation,NOAEC,3 mg/m3,adverse effect observed,rat Trisodium hydrogen ethylenediaminetetraacetate,150-38-9," Oral, rat (similar or equivalent to OECD 401): LD50 > 1780 < 2000 mg/kg bw (read- across from tetrasodium EDTA) Inhalation , rat (OECD 412): LOAEC 30 mg/m3 (read-across from disodium dihydrogen EDTA) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dcb2e6b-1b76-4842-9619-c6684bda9ec8/documents/a7356bf6-8876-4f7e-9d16-dd9e7ba12cd0_35585371-f1ad-4222-b9ad-d94146e8ffe1.html,,,,,, Trisodium hydrogen ethylenediaminetetraacetate,150-38-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dcb2e6b-1b76-4842-9619-c6684bda9ec8/documents/a7356bf6-8876-4f7e-9d16-dd9e7ba12cd0_35585371-f1ad-4222-b9ad-d94146e8ffe1.html,,oral,LD50,"1,780 mg/kg bw",adverse effect observed, "L-Aspartic acid, N,N'-1,2-ethanediylbis-, sodium salt (1:3)",178949-82-1," No human data were identified on trisodium EDDS, and no dermal or inhalation repeated dose laboratory animal data were identified. In a GLP study conducted according to OECD Guideline 408 (available at the time), a 90-d NOAEL of 300 mg/kg bw/day was established for trisodium EDDS based on a reduction in body weight gain and single cell death and fatty infiltration in the pancreas seen of rats at 700 mg/kg bw/day and above following repeated dietary administration. In a GLP study designed to assess toxicity and mineral balance, no adverse effects were observed when trisodium EDDS was given to male rats in the diet for 28 days at up to 400 mg/kg bw/day, considered the study NOAEL. A dose-related and statistically significant increase in the urinary excretion of zinc was observed at all tested doses (50 mg/kg bw/day and above; considered the study LOEL), which was compensated for by a decrease in faecal zinc excretion (measured only in the two highest dose groups) so that the overall total excretion of zinc was unaltered. In a GLP study, trisodium EDDS showed no evidence of toxicity when fed in the diet to male rats for 14 days at up to 1250 mg/kg bw/day, considered the study NOEL. In a 14-day dietary study, trisodium EDDS exhibited toxicity at 2500 mg/kg bw/day and above in male and female rats, seen as loss of body weight, reduced food and water consumption, diarrhoea and hunched posture. The study NOAEL is therefore 500 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/975b4a00-598a-4556-b133-f2b5b3e7e779/documents/IUC5-e9b6764a-ff12-4975-ae06-6d38b60e9d45_b7194a1b-57de-40bc-bc8c-7855ab4f1d32.html,,,,,, "L-Aspartic acid, N,N'-1,2-ethanediylbis-, sodium salt (1:3)",178949-82-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/975b4a00-598a-4556-b133-f2b5b3e7e779/documents/IUC5-e9b6764a-ff12-4975-ae06-6d38b60e9d45_b7194a1b-57de-40bc-bc8c-7855ab4f1d32.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "L-Aspartic acid, N,N'-1,2-ethanediylbis-, sodium salt (1:3)",178949-82-1," No acute toxicity data in humans are available. In GLP studies conducted according to OECD Guideline 401 (available at the time), acute oral LD50 values of >2 g/kg bw (Mahl, 1993a) and >2.7 g/kg bw (Kynoch et al. 1989) have been determined for trisodium EDDS in male and female rats following gavage administration. In a GLP study conducted according to OECD Guideline 403 (available at the time), an acute inhalation 4-h LC50 value of >1.49 mg/L (about 1490 mg/m3; the highest attainable concentration) in air was determined for trisodium EDDS in male and female rats following whole body exposure (Hardy and Jackson, 1989). In GLP studies conducted according to OECD Guideline 402 (available at the time), acute dermal 24-h LD50 values of >2 g/kg bw (Mahl, 1993b) and >2.64 g/kg bw (Liggett and Allan, 1989) have been determined for trisodium EDDS in male and female rabbits and rats, respectively, following semi-occlusive application. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/975b4a00-598a-4556-b133-f2b5b3e7e779/documents/IUC5-d81cf541-51c0-4802-b68a-acfdd2a50792_b7194a1b-57de-40bc-bc8c-7855ab4f1d32.html,,,,,, "L-Aspartic acid, N,N'-1,2-ethanediylbis-, sodium salt (1:3)",178949-82-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/975b4a00-598a-4556-b133-f2b5b3e7e779/documents/IUC5-d81cf541-51c0-4802-b68a-acfdd2a50792_b7194a1b-57de-40bc-bc8c-7855ab4f1d32.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "L-Aspartic acid, N,N'-1,2-ethanediylbis-, sodium salt (1:3)",178949-82-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/975b4a00-598a-4556-b133-f2b5b3e7e779/documents/IUC5-d81cf541-51c0-4802-b68a-acfdd2a50792_b7194a1b-57de-40bc-bc8c-7855ab4f1d32.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "L-Aspartic acid, N,N'-1,2-ethanediylbis-, sodium salt (1:3)",178949-82-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/975b4a00-598a-4556-b133-f2b5b3e7e779/documents/IUC5-d81cf541-51c0-4802-b68a-acfdd2a50792_b7194a1b-57de-40bc-bc8c-7855ab4f1d32.html,,inhalation,LC50,"> 1,490 mg/m3",no adverse effect observed, Trisodium 2-(carboxylatomethyl(2-hydroxyethyl)amino)ethyliminodi(acetate),139-89-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Well documented study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Well documented study; no systemic effects observed Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Well documented study ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38f3128b-9412-4871-9eae-c6e8d52c437a/documents/a7476c60-4a7c-4b2d-bec9-2d5ec7a70a55_849748d7-5744-41e6-b7b9-e2aeb3ea459a.html,,,,,, Trisodium 2-(carboxylatomethyl(2-hydroxyethyl)amino)ethyliminodi(acetate),139-89-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38f3128b-9412-4871-9eae-c6e8d52c437a/documents/a7476c60-4a7c-4b2d-bec9-2d5ec7a70a55_849748d7-5744-41e6-b7b9-e2aeb3ea459a.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Trisodium 2-(carboxylatomethyl(2-hydroxyethyl)amino)ethyliminodi(acetate),139-89-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): A number of studies is available regarding acute oral toxicity providing aweight of evidence that suggests that the LD50 is close to 2000 mg/kg. In the absence of reliable data on the substance itself a key, well documented study, on the analogue tetrasodium EDTA describes the LD50 of that substance being 1780 mg/kg. This is used to determine the acute oral toxicity of this substance and the LD50, recalculated based on to the molecular weight of the two substances, is therefore 1612 mg/kg. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Single study available on the substance itself, 4-h LC50 > 3950 mg/m3 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): No reliable studies available ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38f3128b-9412-4871-9eae-c6e8d52c437a/documents/17a2a1a6-a9a0-42d8-ac3d-5a78c8989d1c_849748d7-5744-41e6-b7b9-e2aeb3ea459a.html,,,,,, Trisodium 2-(carboxylatomethyl(2-hydroxyethyl)amino)ethyliminodi(acetate),139-89-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38f3128b-9412-4871-9eae-c6e8d52c437a/documents/17a2a1a6-a9a0-42d8-ac3d-5a78c8989d1c_849748d7-5744-41e6-b7b9-e2aeb3ea459a.html,,oral,LD50,"1,612 mg/kg bw",adverse effect observed, Trisodium 2-(carboxylatomethyl(2-hydroxyethyl)amino)ethyliminodi(acetate),139-89-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38f3128b-9412-4871-9eae-c6e8d52c437a/documents/17a2a1a6-a9a0-42d8-ac3d-5a78c8989d1c_849748d7-5744-41e6-b7b9-e2aeb3ea459a.html,,inhalation,discriminating conc.,"3,950 mg/m3",no adverse effect observed, Trisodium nitrilotriacetate,5064-31-3,"Oral: Several subacute oral toxicity studies were conducted to assess kidney toxicity in rat (BASF 1997/1998/2003, Merski 1982, Anderson and Kanerva 1978/79). The reversibility of NTA-associated nephrotoxicity was investigated in a subchronic feeding study in SD rats (Myers, 1982). Results indicate a complete recovery of vacuolation and hyperplasia. In some rats hydronephrotic response was clearly sufficiently severe to preclude the restoration of normal renal structure. In subchronic and chronic oral toxicity studies in rat and dog, haematology and histology of a broad spectrum of organs/tissues were performed (Nixon 1971/1972, Budny 1973). In addition there are information from a 2 y repeated dose/carcinogenicity study (NCI, 1977).Inhalation: A subacute inhalation study assessed the effect of Na3NTA on 6 rats, 6 guinea pigs, and 2 monkeys/sex/dose when exposed to graded aerosol for 4 weeks (6 h/d, 5d/w) (P&G, 1971).Dermal: A combined subacute/subchronic dermal toxicity study assessed the effect of 50 mg Na3NTA/kg/d applied to the abraded (28 d) and intact (91 d) skin of 6 New Zealand White rabbits. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09a76a00-3bfc-4da9-a34c-14e01876a4aa/documents/IUC5-81811e21-f72e-44da-975b-5f29e6ad241b_70d61c67-388c-4117-b427-16a21bcf7390.html,,,,,, Trisodium nitrilotriacetate,5064-31-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09a76a00-3bfc-4da9-a34c-14e01876a4aa/documents/IUC5-81811e21-f72e-44da-975b-5f29e6ad241b_70d61c67-388c-4117-b427-16a21bcf7390.html,Chronic toxicity – systemic effects,oral,NOAEL,92 mg/kg bw/day,,rat Trisodium nitrilotriacetate,5064-31-3,"Oral: Three acute oral toxicity studies according or similar to OECD 401 were conducted in Sprague-Dawley rats (5/sex/dose). BASF (1985) reported LD50 values of 1470 mg/kg in females and 2220 mg/kg in males, applying an aqueous solution of 92 % Na3NTA. Monsanto (1986, BD-85-255) reported LD50 values of 3800 mg/kg in females and 5300 mg/kg in males, applying 40 % aqueous solution of Na3NTA. In a second study Monsanto (1986, BD-85-230) reported LD50 values of 1300 mg/kg in females and 1600 mg/kg in males dosing NTA as 99 % Na3NTA monohydrateAs part of a mutagenicity study a LD50 of 1250 mg/kg bw was estimated in male NMRI mice (RCC2000) using a small group size of 2 mice/dose. Several other less reliable studies conducted in rats report oral LD50 values between 1000 mg/kg and 2000 mg/kg (Dow, 1970, 1968, 1967) or at 3715 mg/kg (Monsanto 1968). Nixon (1971) reported acute oral toxicity in different species. A LD50 of 1100 mg/kg were found when applying 20 % NA3NTA to 5 SD rats/sex/dose (998, 1400, 2060, and 1730 mg/kg). In rhesus monkeys a LD 50 of 750 mg/kg was estimated based on deaths at 1000 mg/kg and 2000 mg/kg. Na3NTA was applied as 50 % aqueous solution. In mongrel dogs (4/per dose, 80 % aqueous solution) no death occurred within the observation period of one week after application of 5000 mg/kg Na3NTA (80 % solution), but dogs vomited immediately after application. In addition Nixon (1971) assessed intraperitoneal toxicity in SD rats that is not considered to be relevant for human risk assessment.Dermal: Monsanto tested acute dermal toxicity in 6 New Zealand rabbits up to 10.000 mg/kg (1968)  and as limit test with 2000 mg/kg (1966). Both did not cause mortality.Inhalation: A comprehensive study on inhalation toxicity is available from P&G (1971). In addition a sensory irritation assay was conducted by TNO (2007) applying Na3NTA close to the technically highest attainable concentration. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09a76a00-3bfc-4da9-a34c-14e01876a4aa/documents/IUC5-7df3d74b-cab6-4d02-8590-15e7094546d1_70d61c67-388c-4117-b427-16a21bcf7390.html,,,,,, Trisodium nitrilotriacetate,5064-31-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09a76a00-3bfc-4da9-a34c-14e01876a4aa/documents/IUC5-7df3d74b-cab6-4d02-8590-15e7094546d1_70d61c67-388c-4117-b427-16a21bcf7390.html,,oral,LD50,"1,300 mg/kg bw",, Trisodium nitrilotriacetate,5064-31-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09a76a00-3bfc-4da9-a34c-14e01876a4aa/documents/IUC5-7df3d74b-cab6-4d02-8590-15e7094546d1_70d61c67-388c-4117-b427-16a21bcf7390.html,,dermal,LD50,"10,000 mg/kg bw",, Trisodium orthophosphate,7601-54-9,"The key information has been provided on the analogous substance sodium aluminium phosphate. The key study (Matalski K, 1972b) has been selected as the most reliable or appropriate study for use in the derivation of DNELS. In addition a reliable 28 day study (OECD 422) exists for the analogous substance dipotassium hydrogenorthophosphate (Shim, 2005), however as the study is only a 28-day study and in accordance with Annex XI, Section 3.2 (a.ii) of Regulation (EC) N0. 1907/2006 (REACH) the data are not considered to be suitable for derivation of a DNEL as subchronic data are available. Furthermore, full access to the data has not been granted to all registrants.Additional supporting data provided on sodium dihydrogenorthophosphate are not considered to fulfil the guideline requirements for repeated dose toxicity (sub-chronic or chronic). Full justification for the choice of data and the rationale for read-across can be found below.A reliable 28 day study (OECD 422) exists for the analogous substance dipotassium hydrogenorthophosphate (Shim, 2005), however as the study is only a 28-day study and in accordance with Annex XI, Section 3.2 (a. ii) of Regulation (EC) N0. 1907/2006 (REACH) the data are not considered to be suitable for derivation of a DNEL as subchronic data are availableand as such the data are only supplied as supporting information. Additional supporting data are not considered to fulfil the guideline requirements for repeated dose toxicity (sub-chronic or chronic). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/749cb335-d17c-4fe9-90fc-258fb6eb3656/documents/IUC5-d6fc9c5f-0d1c-43ba-812e-310ee32f020f_5b2639f3-9cb1-4c4c-bc3b-bacf0ff57e1c.html,,,,,, Trisodium orthophosphate,7601-54-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/749cb335-d17c-4fe9-90fc-258fb6eb3656/documents/IUC5-d6fc9c5f-0d1c-43ba-812e-310ee32f020f_5b2639f3-9cb1-4c4c-bc3b-bacf0ff57e1c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,322.88 mg/kg bw/day,,dog Trisodium orthophosphate,7601-54-9,"Acute oral toxicity: Five studies are available to assess the acute oral toxicity of trisodium orthophosphate. All studies indicate that trisodium orthophosphate has a low potential for systemic toxicity following acute administration via the oral route. The key study (Bradshaw J , 2010) has been conducted according to a current guideline (OECD 420) according to the principles of GLP. The acute oral median dose (LD50) of trisodium orthophosphate in the female Wistar strain rat was estimated to be > 2000 mg/kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP). Additional supporting data (Birch MD, 1973 and Sorenson S, 1983) are considered to be sufficient to support the overall classification; however these studies are not sufficient as stand-alone data sources for this endpoint nor as a weight of evidence without the key study.Acute inhalation toxicity: One key study is available to assess the acute inhalation toxicity of the analogous substance sodium dihydrogenorthophosphate. The key study (Signorin J, 1993) has been conducted according to the relevant guidelines (EU and US) and according to the principles of GLP. The acute inhalation median concentration (LC50) in male and female rats was estimated to be > 0.83 mg/L (the maximum attainable concentration). It is therefore anticipated that trisodium orthophosphate is of equally low concern via the inhalation route (see 'discussion' for justification).Acute dermal toxicity: One key study and a number of supporting studies are provided. All studies support no classification. The key study (Moore, 2006) details the acute dermal toxicity of the analogue substance potassium pentahydrogen bis(phosphate) which has an LD50 of >2,000 mg /kg bw and is therefore not classified according to Regulation (EC) No 1272/2008 (EU CLP). This classification can be read across to trisodium orthophosphate on the basis of the argumentation provided below (see 'discussion' for justification). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/749cb335-d17c-4fe9-90fc-258fb6eb3656/documents/IUC5-fd52915e-8da3-47fb-bf65-39fcd10ca8a5_5b2639f3-9cb1-4c4c-bc3b-bacf0ff57e1c.html,,,,,, Glycerol tristearate,555-43-1,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58578371-ae8c-43a7-8256-7b502e36780c/documents/IUC5-cc287480-50ce-4815-835d-5d55e495c86d_4f9be9b2-0a8d-4d41-b1c5-40689ae7f164.html,,,,,, Glycerol tristearate,555-43-1,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58578371-ae8c-43a7-8256-7b502e36780c/documents/IUC5-ef725561-7b04-4b24-b224-e07062f02010_4f9be9b2-0a8d-4d41-b1c5-40689ae7f164.html,,,,,, "Wheat, ext.",84012-44-2,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7143dc91-a480-417e-9b22-b96ad0c468ce/documents/89f723aa-7576-4c5e-bc88-fce0b0403dc8_ccf3caa6-5a24-4d2a-b16c-c3d0091d9048.html,,,,,, Trometamol,77-86-1,"In OECD 408 in rats: Administration of the test material by once daily oral gavage in Wistar Han rats for at least 90 days at dose levels up to 1000 mg/kg bw/day did not result in any adverse findings. High dosage form pH (up to 11.06 for the high dose group) triggered some minor physiological effects, none of which are of relevance for the systemic NOAEL and human safety assessment. Based on these results, the No Observed Adverse Effect Level (NOAEL) was considered to be at least 1000 mg/kg bw/day. supportive data: no systemic toxicity was reported in multiple other in vivo studies (OECD 414, 421, dose-range finding studies, older repeat-dose studies in multiple species). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31a40900-6f64-40d9-b649-636bc2060099/documents/IUC5-ce2620d3-a7ed-4614-a000-cc90c6d1e747_765ffe21-647d-4997-b1d2-d80f8c583d14.html,,,,,, Trometamol,77-86-1,"Oral: Rat: OECD 425, 2011, females: LD0 and LD50 both >= 5000 m/kg, no clinical signs. Old study (1962): LD50 = 6000 mg/kg, no info on clinical signs. Mouse: old studies (1955 and 1962): LD50 = 5500 or 6100 mg/kg, with clinical signs (dose not indicated) Rabbit: undetailed data without report. The data do not warrant any GHS classification. Dermal Rat, OECD 402, males and females: 5000 mg/kg caused no death and no general or local clinical signs. LD0 and LD50 both >= 5000 mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31a40900-6f64-40d9-b649-636bc2060099/documents/IUC5-3934b5c9-2966-4c71-a8df-406dbe13b61e_765ffe21-647d-4997-b1d2-d80f8c583d14.html,,,,,, "2-amino-2-(hydroxymethyl)propane-1,3-diol hydrochloride",1185-53-1," Repeated dose toxicity: OECD 421: NOAEL systemic: >/= 1000 mg/kg bw/d; NOAEL local 100 mg/kg bw/d (result based on read across to source substance trometamol, CAS 77-86-1, EC 201-064 -4) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/964f5e71-4ab0-416e-abec-f8d73c0facc9/documents/IUC5-1ef8ef76-760d-4b48-915a-673907766854_6a02ec4b-d5f0-46a6-9e3a-1a34aea12ee9.html,,,,,, "2-amino-2-(hydroxymethyl)propane-1,3-diol hydrochloride",1185-53-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/964f5e71-4ab0-416e-abec-f8d73c0facc9/documents/IUC5-1ef8ef76-760d-4b48-915a-673907766854_6a02ec4b-d5f0-46a6-9e3a-1a34aea12ee9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-amino-2-(hydroxymethyl)propane-1,3-diol hydrochloride",1185-53-1," Oral: OECD 425, rat: LD50 > 5000 mg/kg bw (result based on read across to source substance trometamol, CAS 77-86-1, EC 201-064-4) Dermal: OECD 402, rat: LD50 > 5000 mg/kg bw (result based on read across to source substance trometamol, CAS 77-86-1, EC 201-064-4) Inhalation: no data available ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/964f5e71-4ab0-416e-abec-f8d73c0facc9/documents/IUC5-a59c6f53-bd11-4be6-9c7c-c8697f3a49a7_6a02ec4b-d5f0-46a6-9e3a-1a34aea12ee9.html,,,,,, "2-amino-2-(hydroxymethyl)propane-1,3-diol hydrochloride",1185-53-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/964f5e71-4ab0-416e-abec-f8d73c0facc9/documents/IUC5-a59c6f53-bd11-4be6-9c7c-c8697f3a49a7_6a02ec4b-d5f0-46a6-9e3a-1a34aea12ee9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-amino-2-(hydroxymethyl)propane-1,3-diol hydrochloride",1185-53-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/964f5e71-4ab0-416e-abec-f8d73c0facc9/documents/IUC5-a59c6f53-bd11-4be6-9c7c-c8697f3a49a7_6a02ec4b-d5f0-46a6-9e3a-1a34aea12ee9.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Trypsin,9002-07-7," Trypsin was tested in Sprague-Dawley rats for 4 weeks. It was concluded that the twice-daily oral administration of SP387/TL-1 to Sprague-Dawley rats for 4 weeks at a range of enzyme activities up to a total daily dose of 6841 KMTU/kg bwt/day was generally well-tolerated, though at the highest dose level there were stomach erosions that were considered responses to an irritant test material and these findings were considered adverse. In view of the presence of these erosions in the high dose animals, the no-observed-adverse-effect level (NOAEL) was considered to be 3420 KMTU/kg bwt/day (1.96 g TOS/kg bw). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63eadb43-88c5-4aa5-99d1-221b33b8b83d/documents/550f21bd-9c7d-4390-90a7-1799b8865c71_9cbeadb6-babb-45a3-a89c-f012caefc97d.html,,,,,, Trypsin,9002-07-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63eadb43-88c5-4aa5-99d1-221b33b8b83d/documents/550f21bd-9c7d-4390-90a7-1799b8865c71_9cbeadb6-babb-45a3-a89c-f012caefc97d.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,960 mg/kg bw/day",,rat Trypsin,9002-07-7, The acute oral toxicity study does not need to be conducted as a 4-week repeated dose oral toxicity study is available. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63eadb43-88c5-4aa5-99d1-221b33b8b83d/documents/7698f5a6-d1ff-4850-8b49-714f90dd96e0_9cbeadb6-babb-45a3-a89c-f012caefc97d.html,,,,,, Tungsten trioxide,1314-35-8," Repeated Dose Toxicity - Oral Route: No oral repeated dose toxicity data of sufficient quality are available for tungsten trioxide (target substance). However, repeated oral dose toxicity data are available for sodium tungstate (source substance), which are used for read-across. Due to lower water solubility and lower toxicity for the target substance compared to the source substance, the resulting read-across from the source substance to the target substance is appropriate as a conservative estimate of potential toxicity for this endpoint. In addition, read-across is appropriate because the classification and labelling is more protective for the source substance than the target substance, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, lower for the source substance. For more details, refer to the read-across category approach in the Category section of this IUCLID submission or Annex 3 in the CSR. The read-across study on sodium tungstate was sponsored conducted the United States Army Center for Health Promotion and Preventive Medicine and published by McCain et al (2015). The 90-day oral toxicity study was conducted in rats according to the procedure described in the Environmental Protection Agency (EPA) Health Effects Testing Guidelines (40 CFR, Part 798.2650) in compliance with Good Laboratory Practice. Briefly, this study of the subchronic toxicity of sodium tungstate dihydrate aqueous solution in male and female Sprague-Dawley rats was evaluated by daily oral gavage of 0, 10, 75, 125, or 200 mg/kg bw/d for 90 days. Measured parameters included food consumption, body weight measurements, hematology, clinical chemistry, and histopathological changes. There was a significant decrease in food consumption and body weight gain in males at 200 mg/kg bw/d from days 77 to 90; however, there was no effect in food consumption and body weights in females. There were no changes in the hematological and clinical parameters studied. Histopathological changes were seen in kidney of male and female and epididymis of male rats. The histopathological changes observed in the kidneys of male and female rats dosed at 125 or 200 mg/k/d consisting of mild to severe cortical tubule basophilia in 2 high-dose groups. Histological changes in epididymides included intraluminal hypospermia with cell debris in the 200 mg/kg bw/day dosed male rats. Histopathological changes were observed in the glandular stomach including inflammation and metaplasia in the high-dose groups (125 or 200 mg/kg bw/day) of both sexes of rats. Based on histopathology effects seen in the kidneys, the lowest observable adverse effect level was 125 mg/kg bw/d and the no observable adverse effect level was 75 mg/kg bw/d in both sexes of rats for oral subchronic toxicity. The US EPA’s Benchmark Dose Software (BMDS, Version 1.4.1) was used to model the data to derive a BMDL10. The lowest (most precautionary) BMDL10 from the renal toxicity endpoint in the 90-day oral toxicity study was 102 mg/kg bw/d. In addition to McCain et al (2015) rat oral 90-day repeated dose study, the US National Toxicology Program (NTP) has conducted two additional 90-day drinking water studies, one in Sprague-Dawley rats and a second one in B6C3F1 mice (10/sex/species/dose). The study design included doses of0, 125, 250, 500, 1000, or 2000 mg/L. The in-life study phase has been completed but no study report has yet been issued. Currently, available in the US NTP website are graphs and Tables are preliminary results, but no full report has been issued. Furthermore, at the 2012 Annual Meeting of the Society of Toxicology, a Scientific Poster was presented detailing preliminary results of the NTP study. Preliminary results confirm the results of the McCain gavage study, showing the kidney as the major target organ for tungstate (especially at high drinking water doses of 1,000 and 2,000 mg/L). The US NTP's final reports of sodium tungstate would be available in 2021 or 2022.   Repeated Dose Toxicity - Inhalation Route: No inhalation repeated dose toxicity data of sufficient quality were available for tungsten trioxide; however, data were available for tungsten oxide, which will be used for read-across A 28-day inhalation toxicity study conducted according to OECD 412 is available on tungsten blue oxide, which is considered the key repeated dose study. In this study, 5 rats/sex/dose were given TBO nose-only for 6 hours per day, 7 days/week, for 28 days (with a 14-day recovery period) at doses of 0 (control), 0.08, 0.325, and 0.65 mg/L air. The NOAEC was deemed to be > 0.65 mg/L air (650 mg/m3), as no significant effects were reported. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96ac777f-ced9-488b-96f2-baed13a6d62a/documents/cdb94a59-6571-4244-b739-a498a96c793a_bb99b49f-dcee-44bf-8c76-f92822060d4e.html,,,,,, Tungsten trioxide,1314-35-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96ac777f-ced9-488b-96f2-baed13a6d62a/documents/cdb94a59-6571-4244-b739-a498a96c793a_bb99b49f-dcee-44bf-8c76-f92822060d4e.html,Sub-chronic toxicity – systemic effects,oral,BMDL10,102 mg/kg bw/day,,rat Tungsten trioxide,1314-35-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96ac777f-ced9-488b-96f2-baed13a6d62a/documents/cdb94a59-6571-4244-b739-a498a96c793a_bb99b49f-dcee-44bf-8c76-f92822060d4e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,650 mg/m3,,rat Tungsten trioxide,1314-35-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96ac777f-ced9-488b-96f2-baed13a6d62a/documents/cdb94a59-6571-4244-b739-a498a96c793a_bb99b49f-dcee-44bf-8c76-f92822060d4e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,650 mg/m3,no adverse effect observed,rat Tungsten trioxide,1314-35-8," In an acute oral toxicity study conducted on rats and according to OECD 423, the LD50 was reported to be >2000 mg/kg for tungsten trioxide. In an acute inhalation toxicity study conducted on rats and according to OECD 403, the LC50 was reported to be >5.36 mg/L for tungsten trioxide. No acute dermal toxicity data were available for tungsten trioxide; however, an acute dermal toxicity study was available on sodium tungstate, which are used for read-across. The acute dermal LD50 for sodium tungstate was determined to be > 2000 mg/kg. For more details, refer to the read-across category approach description in the Category section of this IUCLID submission or Annex 3 of the CSR. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96ac777f-ced9-488b-96f2-baed13a6d62a/documents/35a89880-5b71-425e-96c2-feba40d286e7_bb99b49f-dcee-44bf-8c76-f92822060d4e.html,,,,,, Tungsten trioxide,1314-35-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96ac777f-ced9-488b-96f2-baed13a6d62a/documents/35a89880-5b71-425e-96c2-feba40d286e7_bb99b49f-dcee-44bf-8c76-f92822060d4e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tungsten trioxide,1314-35-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96ac777f-ced9-488b-96f2-baed13a6d62a/documents/35a89880-5b71-425e-96c2-feba40d286e7_bb99b49f-dcee-44bf-8c76-f92822060d4e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tungsten trioxide,1314-35-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96ac777f-ced9-488b-96f2-baed13a6d62a/documents/35a89880-5b71-425e-96c2-feba40d286e7_bb99b49f-dcee-44bf-8c76-f92822060d4e.html,,inhalation,LC50,"5,360 mg/m3",adverse effect observed, "Turpentine, oil",8006-64-2,"In an ​OECD Test Guideline 40​8 study conducted in compliance with GLP, TOPP was​ administe​red daily ​via oral g​avage to H​an Wistar ​rats (RccH​an™;WIST) ​for 13 wee​ks, with a subsequent four-week recovery period. Three ​groups, ea​ch compris​ing ten ma​les and te​n females,​ received ​TOPP in co​rn oil (do​ses 30, 10​0 and 300 mg​/kg/bw/day,​ respectiv​ely) and a C​ontrol gro​up (corn o​il only) (Labcorp, 2024). ​A further​ five male​s and five​ females w​ere assign​ed to each​ of the co​ntrol and ​high dose ​groups and​ these ani​mals were ​treated fo​r 13 weeks​, followed​ by a four​-week peri​od without​ treatment​ to assess​ the poten​tial for a​ny treatme​nt-related​ change to​ recover. ​During ​the initia​l few weeks of ​the study ​there was ​a high inc​idence of ​female mor​talities i​n the high​ dose grou​p (300 mg/​kg/bw/day)​. This dos​e was subs​equently r​educed to ​150 mg/kg bw/day fro​m Week 6 onwards for​ both sexe​s. Apart from mortality, there were no significant adverse findings and the NOAEL was therefore concluded to be 100 mg/kg bw/day. Following reduction of the high dose to 150 mg/kg bw/day, there was no additional mortality, which adds confidence to the NOAEL of 100 mg/kg bw/day.    A study for repeated dose toxicity is available for the major constituent of TOPP, α-pinene. A 90-day subchronic toxicity study by the inhalation route was conducted in accordance with OECD Test Guideline 413 with deviations (no food consumption, haematology, ophthalmological examination, some organ weights were not recorded). The No Observed Adverse Effect Concentration (NOAEC) was reported as 200 ppm for females, based on mortality and lower body weight gain at the higher dose level of 400 ppm. No NOAEC was established for males since examination of the male kidneys at all dose levels revealed lesions including granular casts and hyaline droplets indicative of alpha-2u-globulin nephropathy. This is a known male rat-specific effect and is not relevant for human health hazard assessment. The overall NOAEC relevant for humans is therefore 200 ppm (equivalent to 1114 mg/m3).   A number of other studies for the oral and inhalation routes do not indicate that any of the terpene constituents of TOPP for which data are available require classification for specific target organ toxicity following repeated exposures.   Studies with sulfur-containing constituents of TOPP do report adverse effects following repeated inhalation and dermal exposure. Following dermal exposure none of these effects are classified for specific target organ toxicity. Furthermore, at the concentrations typically present in TOPP these would not contribute to the overall classification according to the rules for mixtures in Regulation (EC) No 1272/2008.       Conclusions for repeated dose toxicity       Qualitative hazard conclusions for the registered substance itself are based on the classifications for skin sensitisation and eye irritation. In addition, quantitative DNEL values for ‘whole substance’ are calculated from the available key data.   In addition for worker assessment, quantitative hazard conclusions are presented for sulfur-containing constituents (Block E), based on the data for dimethyl disulfide as a worst-case. DNELs for dimethyl disulfide (CAS 624-92-0) are based on the values reported in the disseminated REACH dossier for that substance for consistency.   DNELs for the oral and inhalation routes (man via the environment) can be calculated on a block-specific basis. See Section 7.0 of IUCLID and 5.11 of the CSR (Toxicological information) for further information.     ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a4cc1d6-dd2f-46d0-a32d-521c69c7788c/documents/b0f7c1b3-4f83-438a-b9a9-4af70ce0de6a_cf48f990-e1bf-472c-b520-f249926aa492.html,,,,,, "Turpentine, oil",8006-64-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a4cc1d6-dd2f-46d0-a32d-521c69c7788c/documents/b0f7c1b3-4f83-438a-b9a9-4af70ce0de6a_cf48f990-e1bf-472c-b520-f249926aa492.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Turpentine, oil",8006-64-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a4cc1d6-dd2f-46d0-a32d-521c69c7788c/documents/b0f7c1b3-4f83-438a-b9a9-4af70ce0de6a_cf48f990-e1bf-472c-b520-f249926aa492.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,114 mg/m3",,rat "Turpentine, oil",8006-64-2,"Acute Oral: In an acute oral toxicity study (Moreno, 1972a) with male Wistar rats, the LD50 of turpentine oil (CAS 8006-64-2) was determined to be 4.6 ml/kg (equivalent to ca. 4000 mg/kg bw) with 95% confidence limits of 3.9-5.6 ml/kg bw. Clinical signs were slight ataxia and lethargy. No abnormalities were detected at necropsy.   Acute Dermal: In an acute dermal toxicity study (Moreno, 1972c) with New Zealand White rabbits, the LD50 of turpentine oil (CAS 8006-64-2) was determined to be >2000 mg/kg bw. No adverse clinical signs were reported, although local irritant effects were noted. No necropsy findings were reported.   Acute Inhalation: In an acute vapour inhalation study (Sperling, 1967) with male rats, the LC50 of turpentine oil (CAS 8006-64-2) was determined to be 13.7 mg/l. Clinical signs reported were convulsions and apnoea; increase in respiratory rate and decrease in tidal volume. No treatment-related necropsy findings were detected.   In addition to these key data for the registration substance, reliable acute oral, dermal and inhalation toxicity studies are reported in ECHA dissemination dossiers for a number of individual constituents of TOPP. In all cases other than dimethyl disulfide and methanethiol, the reported LD50 values exceed cut-offs for classification for acute toxicity according to Regulation (EC) No 1272/2008. In the majority of these studies no treatment-related effects were noted. The data indicate that the terpene constituents are not expected to contribute to the acute toxicity profile of TOPP. The sulfur-containing constituents are discussed below.   Sulfur-containing constituents of TOPP TOPP contains low concentrations of the sulfur-containing substances methyl mercaptan (methanethiol, typically 0-1.95%), dimethyl sulfide (typically 0-9.12%) and dimethyl disulfide (0-1.33%).    Neither dimethyl sulfide nor dimethyl disulfide is classified for acute toxicity in Annex VI of EC Regulation 1272/2008/EC. However, the available acute oral and inhalation studies that are reported for dimethyl disulfide are consistent with classification as Acute Toxic 4 for the oral route, and Acute Toxic 3 for the inhalation route. A proposal for harmonised classification published on ECHA’s website confirms this conclusion (https://echa.europa.eu/harmonised-classification-and-labelling-previous-consultations/-/substance-rev/16703/term?_viewsubstances_WAR_echarevsubstanceportlet_SEARCH_CRITERIA_EC_NUMBER=210-871-0&_viewsubstances_WAR_echarevsubstanceportlet_DISS=true).   Methyl mercaptan (methanethiol, CAS 74-93-1) has a harmonised classification for acute inhalation toxicity (Category 3) in Annex VI of Regulation (EC) No 1272/2008.   At the concentrations present in TOPP, the contribution of acute inhalation toxicity to the mixture would not exceed the cut-offs for the existing ""Harmful by inhalation"" or ""Acute Toxicity Category 4"" classification for the whole substance according to the rules for mixtures outlined in Regulation (EC) No 1272/2008/EC.   Dimethyldisulfide (DMDS) is classified as STOT SE 1 (Specific target organ toxicity single exposure category 1, upper respiratory tract, inhalation), therefore the STOT SE 2 classification is added to TOPP if it contains DMDS ≥1%. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a4cc1d6-dd2f-46d0-a32d-521c69c7788c/documents/08bd0ed9-68c9-4511-b79a-e15e295d6d43_cf48f990-e1bf-472c-b520-f249926aa492.html,,,,,, "Turpentine, oil",8006-64-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a4cc1d6-dd2f-46d0-a32d-521c69c7788c/documents/08bd0ed9-68c9-4511-b79a-e15e295d6d43_cf48f990-e1bf-472c-b520-f249926aa492.html,,oral,LD50,"4,000 mg/kg bw",no adverse effect observed, "Turpentine, oil",8006-64-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a4cc1d6-dd2f-46d0-a32d-521c69c7788c/documents/08bd0ed9-68c9-4511-b79a-e15e295d6d43_cf48f990-e1bf-472c-b520-f249926aa492.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Turpentine, oil",8006-64-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a4cc1d6-dd2f-46d0-a32d-521c69c7788c/documents/08bd0ed9-68c9-4511-b79a-e15e295d6d43_cf48f990-e1bf-472c-b520-f249926aa492.html,,inhalation,LC50,"13,700 mg/m3",adverse effect observed, Tyrosine,60-18-4,"L-tyrosine was evaluated in a 13-week repeated-dose oral toxicity study in rats according to OECD 408, non-GLP. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a76cc463-4cdb-47a1-8ed2-ec3a528b945c/documents/1105de5a-961b-4a26-adf4-d9e177e15175_9f305fea-24be-4112-aa23-9f61850ccfb5.html,,,,,, Tyrosine,60-18-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a76cc463-4cdb-47a1-8ed2-ec3a528b945c/documents/1105de5a-961b-4a26-adf4-d9e177e15175_9f305fea-24be-4112-aa23-9f61850ccfb5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Tyrosine,60-18-4,No acute effects were observed in the WoE studies by oral exposure of Tyrosine.  ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a76cc463-4cdb-47a1-8ed2-ec3a528b945c/documents/88c1afe9-fdbc-4a87-ba5c-21850bb798e9_9f305fea-24be-4112-aa23-9f61850ccfb5.html,,,,,, Undecanal,112-44-7,"In an OECD TG 422 study, undecanal did not cause systemic toxicity in male and female rats at doses (oral gavage) up to and including 1000 mg/kg bw and day. Local irritation in the stomach was noted at all dose levels starting at 100 mg/kg bw and day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfbf296f-a791-4c9f-a2a4-e7ccddf2c71f/documents/IUC5-227bd728-e52e-4e03-9e64-33cf55ad585d_abf72a00-9b02-4266-b741-7de8f1d5267b.html,,,,,, Undecanal,112-44-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfbf296f-a791-4c9f-a2a4-e7ccddf2c71f/documents/IUC5-227bd728-e52e-4e03-9e64-33cf55ad585d_abf72a00-9b02-4266-b741-7de8f1d5267b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Undecanal,112-44-7,"The LD50 for acute oral toxicity is given as > 5000 mg/kg bw (Ruhrchemie AG/Safepharm, 1985; RL2, rat). For acute dermal toxicity a LD > 5000 mg/kg bw was determined (Shelanski and Moldovan, 1971; RL2, rabbit). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfbf296f-a791-4c9f-a2a4-e7ccddf2c71f/documents/IUC5-fc865a5c-09aa-4c32-a43f-8f5d5b793439_abf72a00-9b02-4266-b741-7de8f1d5267b.html,,,,,, Undecanal,112-44-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfbf296f-a791-4c9f-a2a4-e7ccddf2c71f/documents/IUC5-fc865a5c-09aa-4c32-a43f-8f5d5b793439_abf72a00-9b02-4266-b741-7de8f1d5267b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Undecanal,112-44-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfbf296f-a791-4c9f-a2a4-e7ccddf2c71f/documents/IUC5-fc865a5c-09aa-4c32-a43f-8f5d5b793439_abf72a00-9b02-4266-b741-7de8f1d5267b.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Undecane,1120-21-4,Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test – NOAEL ≥ 1000 mg/kg for rats (OECD 422)   Repeated Dose Oral 90d - NOAEL ≥ 5000 mg/kg bw/day for rats (OECD 408)   Repeated Dose Inhalation 90d – NOAEC ≥ 10400 mg/m3 for rats (similar to OECD TG 413) ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c47a49b-9cab-4a36-a877-93c9728517a8/documents/7ee31dec-4348-419f-8813-64c695eff6db_ea2f929a-fab3-487d-9b69-1f1400bd9ea6.html,,,,,, Undecane,1120-21-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c47a49b-9cab-4a36-a877-93c9728517a8/documents/7ee31dec-4348-419f-8813-64c695eff6db_ea2f929a-fab3-487d-9b69-1f1400bd9ea6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat Undecane,1120-21-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c47a49b-9cab-4a36-a877-93c9728517a8/documents/7ee31dec-4348-419f-8813-64c695eff6db_ea2f929a-fab3-487d-9b69-1f1400bd9ea6.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"10,400 mg/m3",,rat Undecane,1120-21-4,Acute Toxicity-Oral LD50 > 5000 mg/kg in rats (OECD TG 401)   Acute Toxicity-Inhalation LC50 > 2825.69 mg/m3 (maximum attainable vapour concentration of n-C11) (OECD TG 403)   Acute Toxicity-Dermal LD50 > 3160 mg/kg in rabbits (OECD TG 402) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c47a49b-9cab-4a36-a877-93c9728517a8/documents/a1958384-2da5-414f-8545-84d1b3cd6c70_ea2f929a-fab3-487d-9b69-1f1400bd9ea6.html,,,,,, Undecane,1120-21-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c47a49b-9cab-4a36-a877-93c9728517a8/documents/a1958384-2da5-414f-8545-84d1b3cd6c70_ea2f929a-fab3-487d-9b69-1f1400bd9ea6.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Undecane,1120-21-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c47a49b-9cab-4a36-a877-93c9728517a8/documents/a1958384-2da5-414f-8545-84d1b3cd6c70_ea2f929a-fab3-487d-9b69-1f1400bd9ea6.html,,dermal,LD50,"3,160 mg/kg bw",no adverse effect observed, Undecane,1120-21-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c47a49b-9cab-4a36-a877-93c9728517a8/documents/a1958384-2da5-414f-8545-84d1b3cd6c70_ea2f929a-fab3-487d-9b69-1f1400bd9ea6.html,,inhalation,LC50,"2,825.69 mg/m3",no adverse effect observed, Undecenal,1337-83-3,The test material Undecanal is likely to be non toxic upon repeated exposure. ,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/656424b3-a9c7-4d31-b02c-e1c94fe5b274/documents/IUC5-e38b7446-9f16-400b-8b06-9ffe12e5144b_55f453c8-5af2-4bf3-8a8b-d796adaef003.html,,,,,, Undecenal,1337-83-3,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/656424b3-a9c7-4d31-b02c-e1c94fe5b274/documents/IUC5-e38b7446-9f16-400b-8b06-9ffe12e5144b_55f453c8-5af2-4bf3-8a8b-d796adaef003.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,680 mg/kg bw/day,,rat Undecenal,1337-83-3, LD50 was estimated to be 4103.573730469 and 4348.187011719 mg/kg bw when rat and rabbits were treated with undecenal orally and dermally. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/656424b3-a9c7-4d31-b02c-e1c94fe5b274/documents/IUC5-aa21061f-f054-46f3-b5c9-6bffa362cb23_55f453c8-5af2-4bf3-8a8b-d796adaef003.html,,,,,, Undecenal,1337-83-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/656424b3-a9c7-4d31-b02c-e1c94fe5b274/documents/IUC5-aa21061f-f054-46f3-b5c9-6bffa362cb23_55f453c8-5af2-4bf3-8a8b-d796adaef003.html,,oral,LD50,"4,103.574 mg/kg bw",no adverse effect observed, Undecenal,1337-83-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/656424b3-a9c7-4d31-b02c-e1c94fe5b274/documents/IUC5-aa21061f-f054-46f3-b5c9-6bffa362cb23_55f453c8-5af2-4bf3-8a8b-d796adaef003.html,,dermal,LD50,"4,348.187 mg/kg bw",no adverse effect observed, Undecan-1-ol,112-42-5," In the key study, no adverse effects were seen after dietary administration of Alcohols, C14-15-branched and linear for 90 days to rats (Ito et al., 1978) which reported a NOAEL value of >3548 mg/kg bw/day. A read across from a reliable 13 week dietary study in rats using hexan-1-ol reported a NOAEL of 1127 mg/kg (Scientific Associates Inc., 1966). No adverse effects were noted at any of the dose levels administered during the study. The results are also supported by a reliable three week feeding study in rats using hexan-1-ol which reported a NOAEL of approximately 1000 mg/kg bw/day (Moody 1978 ).  In addition a 90 day repeated dose dermal study (Wil Research 1995) in rats where a multi-constituent solution containing circa 50% decan-1-ol and circa 45% octan-1-ol (semi-occluded conditions) reported no systemic effects at the highest dose tested. The study did however give rise to marked dermal irritative effect. It is however important to take in to account the different test protocol that was used, that is a 90 day repeated dose dermal study (6 hours/day for 5 days/week) compared to a standard 4 hour dermal irritation study and the different species (rats instead of rabbit) and test duration (90 days vs. 4 hours). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed754eac-1d59-41ad-9e0a-13d6471fbc00/documents/09a7ea13-cebf-430a-9191-c93789692294_ac09418e-45d1-4407-8850-2e84ba26ecfa.html,,,,,, Undecan-1-ol,112-42-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed754eac-1d59-41ad-9e0a-13d6471fbc00/documents/09a7ea13-cebf-430a-9191-c93789692294_ac09418e-45d1-4407-8850-2e84ba26ecfa.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,548 mg/kg bw/day",,rat Undecan-1-ol,112-42-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed754eac-1d59-41ad-9e0a-13d6471fbc00/documents/09a7ea13-cebf-430a-9191-c93789692294_ac09418e-45d1-4407-8850-2e84ba26ecfa.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat Undecan-1-ol,112-42-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed754eac-1d59-41ad-9e0a-13d6471fbc00/documents/09a7ea13-cebf-430a-9191-c93789692294_ac09418e-45d1-4407-8850-2e84ba26ecfa.html,Repeated dose toxicity – local effects,dermal,NOAEL,2.8 mg/cm2,adverse effect observed,rat Undecan-1-ol,112-42-5," The acute oral toxicity key study reports an LD50 value of >15800 mg/kg in rat in a reliability 2 study (Younger Labs 1972). The inhalation key study reports and LC50 value of 700 mg/m³ air in response to a 6 hour exposure (Younger Labs 1972), which is the only available information for the inhalation endpoint. The rabbit acute dermal LD50 value was reported to be >5010 mg/kg (Younger Labs 1972). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed754eac-1d59-41ad-9e0a-13d6471fbc00/documents/27cd9f68-c033-41d6-af80-760fde69d707_ac09418e-45d1-4407-8850-2e84ba26ecfa.html,,,,,, Undecan-1-ol,112-42-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed754eac-1d59-41ad-9e0a-13d6471fbc00/documents/27cd9f68-c033-41d6-af80-760fde69d707_ac09418e-45d1-4407-8850-2e84ba26ecfa.html,,oral,LD50,"15,800 mg/kg bw",no adverse effect observed, Undecan-1-ol,112-42-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed754eac-1d59-41ad-9e0a-13d6471fbc00/documents/27cd9f68-c033-41d6-af80-760fde69d707_ac09418e-45d1-4407-8850-2e84ba26ecfa.html,,dermal,LD50,"5,010 mg/kg bw",no adverse effect observed, Undecan-1-ol,112-42-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed754eac-1d59-41ad-9e0a-13d6471fbc00/documents/27cd9f68-c033-41d6-af80-760fde69d707_ac09418e-45d1-4407-8850-2e84ba26ecfa.html,,inhalation,LC50,700 mg/m3,no adverse effect observed, Undecyl glucoside,98283-67-1,"RDT (Oral, EU Method B.26, 90-day), rat (m/f): NOAEL (systemic) ≥1000 mg/kg bw/day (RA from D-Glucopyranose, oligomeric, C10-16-alkyl glycosides)RDT (inhalation) - WaivingRDT (dermal) - Waiving ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b54976d8-7f9f-4e26-8372-8aa690e0495f/documents/IUC5-9d7d4925-ed6e-49a3-b96a-4104b27f6bfe_e3eb1fb5-d781-404a-88a2-f6b9e47cf836.html,,,,,, Undecyl glucoside,98283-67-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b54976d8-7f9f-4e26-8372-8aa690e0495f/documents/IUC5-9d7d4925-ed6e-49a3-b96a-4104b27f6bfe_e3eb1fb5-d781-404a-88a2-f6b9e47cf836.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"> 1,000 mg/kg bw/day",,rat Undecyl glucoside,98283-67-1,"Oral (OECD 423), rat (f): LD50 (cut-off) >5000 mg/kg bw (limit test) Inhalation: Data waiving Dermal (OECD 402), rat (m/f): LD50 >2000 mg/kg bw (limit test) (RA from CAS 110615 -47 -9 and CAS 68515 -73 -1) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate, reliable (Klimisch score 2 due to read-across) studies from reference substances with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products and similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details). Taken together, the information from these independent sources is consistent and provides sufficient weight of evidence for hazard assessment leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006. Therefore, the available information as a whole is sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b54976d8-7f9f-4e26-8372-8aa690e0495f/documents/IUC5-a972ad04-4d99-41ac-a4d6-d7378b3162cb_e3eb1fb5-d781-404a-88a2-f6b9e47cf836.html,,,,,, Undecyl glucoside,98283-67-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b54976d8-7f9f-4e26-8372-8aa690e0495f/documents/IUC5-a972ad04-4d99-41ac-a4d6-d7378b3162cb_e3eb1fb5-d781-404a-88a2-f6b9e47cf836.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Undecyl glucoside,98283-67-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b54976d8-7f9f-4e26-8372-8aa690e0495f/documents/IUC5-a972ad04-4d99-41ac-a4d6-d7378b3162cb_e3eb1fb5-d781-404a-88a2-f6b9e47cf836.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Undec-10-enal,112-45-8," Repeated dose toxicity : Oral OECD 407 (2008) study with inclusion of ophthalamic examinations: NOAEL was established at 1000 mg/kg bw/day in both male and female rats. OECD 408 (1998) study: NOAEL was established at 138.6 mg/kg bw/day in both male and female rats based on adverse effects on body weight at 382.3 mg/kg bw/day. Repeated dose toxicity: Inhalation Undec-10-enal(CAS no 112-45-8) has very low vapor pressure (0.065mm Hg at 25˚C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver Repeated dose toxicity: Dermal The acute dermal toxicity value for Undec-10-enal(CAS no 112-45-8) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fecd5cdd-8894-418f-a260-e50d13f045e7/documents/9c81ec3c-cc27-4e9d-9375-d0c0b14b2506_9c59c0e7-e8f7-49c9-a79a-a12501740c3f.html,,,,,, Undec-10-enal,112-45-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fecd5cdd-8894-418f-a260-e50d13f045e7/documents/9c81ec3c-cc27-4e9d-9375-d0c0b14b2506_9c59c0e7-e8f7-49c9-a79a-a12501740c3f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,138.6 mg/kg bw/day,,rat Undec-10-enal,112-45-8," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on study conducted for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.060 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on study conducted on rats for the test chemical. The studies concluded that the LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fecd5cdd-8894-418f-a260-e50d13f045e7/documents/9e386440-6041-460a-bd0d-0d3f6e0039e8_9c59c0e7-e8f7-49c9-a79a-a12501740c3f.html,,,,,, Undec-10-enal,112-45-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fecd5cdd-8894-418f-a260-e50d13f045e7/documents/9e386440-6041-460a-bd0d-0d3f6e0039e8_9c59c0e7-e8f7-49c9-a79a-a12501740c3f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Undec-10-enal,112-45-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fecd5cdd-8894-418f-a260-e50d13f045e7/documents/9e386440-6041-460a-bd0d-0d3f6e0039e8_9c59c0e7-e8f7-49c9-a79a-a12501740c3f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, (carboxymethyl)dimethyl[3-[(1-oxoundecenyl)amino]propyl]ammonium hydroxide,98510-75-9,"- subacute (28 d) repeated dose toxicity study with additional focus on reproductive organs, oral (gavage), Sprague-Dawley rat, m/f; OECD TG 407; GLP; RL1, dose levels: 0, 100, 300, 500 mg a.i./kg bw/d; NOAEL = 500 mg/kg bw/d; read-across: C8-10 Alkylamidopropyl betaine- subchronic (90 d) repeated dose toxicity study with additional focus on reproductive organs, oral (gavage), Sprague-Dawley rat, m/f; OECD TG 408; GLP; RL1, dose levels: 0, 75, 150, 300 mg a.i./kg bw/d; NOEL = 300 mg/kg bw/d; read-across: C8-18 AAPB- subchronic (90 d) repeated dose toxicity study with additional focus on reproductive organs, oral (diet), Wistar rat, m/f; OECD TG 408; GLP; RL1, dose levels: 0, 9.5, 24, 97 and 247 mg a.i./kg bw/day/d; NOEL = 247 mg/kg bw/d; read-across: C8-18 and C18 unsatd. AAPB (Coco AAPB)- subchronic (90 d) repeated dose toxicity study with additional focus on reproductive organs, oral (gavage), Wistar rat, m/f; OECD TG 408; GLP; RL1, dose levels: 0, 100, 300, 1000 mg a.i./kg bw/day; NOAEL = 1000 mg/kg bw/d; read-across: Formamidopropylbetaine ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d527cd32-0d67-4c85-86df-1ea1d898bd75/documents/IUC5-f41d75ab-1118-4a75-8c6e-e0f0c1c971ed_05080cb2-300d-448d-97d5-59c19c9da15b.html,,,,,, (carboxymethyl)dimethyl[3-[(1-oxoundecenyl)amino]propyl]ammonium hydroxide,98510-75-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d527cd32-0d67-4c85-86df-1ea1d898bd75/documents/IUC5-f41d75ab-1118-4a75-8c6e-e0f0c1c971ed_05080cb2-300d-448d-97d5-59c19c9da15b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat (carboxymethyl)dimethyl[3-[(1-oxoundecenyl)amino]propyl]ammonium hydroxide,98510-75-9,"Oral:-LD50 > 2000 mg/kg bw (based on test material) / LD50 > 830 mg a.i./kg bw; OECD TG 423, rat (female) oral: gavage (RL1, GLP); read-across: Formamidopropylbetaine-LD50 = 2335 mg a.i./kg bw; Similar to OECD TG 401, standard acute method, rat oral: gavage (RL1; pre-GLP); read-across: C8-18 and C18 unsatd. AAPBDermal:-LD50 > 2000 mg a.i./kg bw; OECD TG 402, rat, Type of coverage: Occlusive (RL1, GLP); read-across: Formamidopropylbetaine-LD50 > 2000 mg/kg bw (based on test material) / LD50 > 620 mg a.i./kg bw; OECD TG 402, rat, Type of coverage: Occlusive (RL1, GLP); read-across: C8-18 and C18 unsatd. AAPBInhalation-No relevant route of exposure ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d527cd32-0d67-4c85-86df-1ea1d898bd75/documents/IUC5-950baba6-a45a-4fe5-a949-e0100f358ba9_05080cb2-300d-448d-97d5-59c19c9da15b.html,,,,,, (carboxymethyl)dimethyl[3-[(1-oxoundecenyl)amino]propyl]ammonium hydroxide,98510-75-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d527cd32-0d67-4c85-86df-1ea1d898bd75/documents/IUC5-950baba6-a45a-4fe5-a949-e0100f358ba9_05080cb2-300d-448d-97d5-59c19c9da15b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, (carboxymethyl)dimethyl[3-[(1-oxoundecenyl)amino]propyl]ammonium hydroxide,98510-75-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d527cd32-0d67-4c85-86df-1ea1d898bd75/documents/IUC5-950baba6-a45a-4fe5-a949-e0100f358ba9_05080cb2-300d-448d-97d5-59c19c9da15b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate,94313-91-4, The NOEL in a 90 day sub-chronic dietary study in the rat was 3000 ppm. The NOEL in a 90 day sub-chronic study with a similar substance (methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate) in the dog was 75 mg/kg (top dose limited by the palatability of the substance in the diet). ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b7e0f6b-f27a-4ed0-89c8-4a9feba71e64/documents/IUC5-7ae217a9-53af-4376-85a1-041c1f264e5c_529c9e9a-8250-4f2b-ae11-80ad4eec9387.html,,,,,, Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate,94313-91-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b7e0f6b-f27a-4ed0-89c8-4a9feba71e64/documents/IUC5-7ae217a9-53af-4376-85a1-041c1f264e5c_529c9e9a-8250-4f2b-ae11-80ad4eec9387.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,286 mg/kg bw/day,,rat Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate,94313-91-4, The substance is of low acute toxicity in mammals by both the oral and dermal routes. The acute oral LD50 is > 2350 mg/kg (based on active ingredient) while the acute dermal LD50 is > 2000 mg/kg (based on test material). The acute dermal toxicity has been addressed by use of read-across from a structurally related substance (methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate; CAS No.10595-49-0).Testing by the inhalation route is not scientifically justified. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b7e0f6b-f27a-4ed0-89c8-4a9feba71e64/documents/IUC5-1c6a9ad8-010d-494e-90dc-cf2aca2d6b5e_529c9e9a-8250-4f2b-ae11-80ad4eec9387.html,,,,,, Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate,94313-91-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b7e0f6b-f27a-4ed0-89c8-4a9feba71e64/documents/IUC5-1c6a9ad8-010d-494e-90dc-cf2aca2d6b5e_529c9e9a-8250-4f2b-ae11-80ad4eec9387.html,,oral,LD50,"2,350 mg/kg bw",no adverse effect observed, Trimethyl-3-[(1-oxo-10-undecenyl)amino]propylammonium methyl sulphate,94313-91-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b7e0f6b-f27a-4ed0-89c8-4a9feba71e64/documents/IUC5-1c6a9ad8-010d-494e-90dc-cf2aca2d6b5e_529c9e9a-8250-4f2b-ae11-80ad4eec9387.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Undec-10-enoic acid,112-38-9,"A Klimisch 1 rated key study was carried out in 1999. The test item was applied orally for 13 weeks according to OECD 408. The observed NOAEL was 60 mg/kg bw/day, the LOAEL was 180 mg/kg bw/day where the target organ was the heart in which a degenerative cardiomyopathy was seen. Reversibility was observed for this effect . No chronic studies in inhalative or dermal application route conducted. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5c965f3-9cbc-4f15-b7c3-6c35a1e46e6f/documents/IUC5-91ab4a7e-b64d-4b0d-88af-9160c290fd26_318452f2-0cd9-487a-8871-ef8ad6e0b10d.html,,,,,, Undec-10-enoic acid,112-38-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5c965f3-9cbc-4f15-b7c3-6c35a1e46e6f/documents/IUC5-91ab4a7e-b64d-4b0d-88af-9160c290fd26_318452f2-0cd9-487a-8871-ef8ad6e0b10d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat Undec-10-enoic acid,112-38-9,"One Klimisch 1 rated key study on acute oral toxicity (Manciaux, 1999) and one Klimisch 1 rated key study on dermal toxicity have been carried out with rats (Manciaux, 1999). According to these studies, there is no relevant acute toxic effect coming from the test item undeceonic acid up to a dose level 2000 mg/kg bw/d, thus there is no classification. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5c965f3-9cbc-4f15-b7c3-6c35a1e46e6f/documents/IUC5-10f4e6e7-018a-4b4e-9824-df7b961e46aa_318452f2-0cd9-487a-8871-ef8ad6e0b10d.html,,,,,, Undec-10-enoic acid,112-38-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5c965f3-9cbc-4f15-b7c3-6c35a1e46e6f/documents/IUC5-10f4e6e7-018a-4b4e-9824-df7b961e46aa_318452f2-0cd9-487a-8871-ef8ad6e0b10d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Undec-10-enoic acid,112-38-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5c965f3-9cbc-4f15-b7c3-6c35a1e46e6f/documents/IUC5-10f4e6e7-018a-4b4e-9824-df7b961e46aa_318452f2-0cd9-487a-8871-ef8ad6e0b10d.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Urea,57-13-6,"12-month carcinogenicity screening studies in the rat and mouse demonstrate that urea is of very low chronic toxicity by the oral route. Similarly, no evidence of local or systemic toxicity was seen in 4-week and 25-week dermal toxicity studies in the rat. No clear toxicity was seen in dogs administered high doses of urea by subcutaneous injection over a period 45 days. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb3322f7-0ca2-4384-82c7-279e4fc242b0/documents/924d4d4f-0b39-4a5c-b740-08cdf5e96b3a_2ed1aec4-c036-4001-b7b9-cc72ec0cf352.html,,,,,, Urea,57-13-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb3322f7-0ca2-4384-82c7-279e4fc242b0/documents/924d4d4f-0b39-4a5c-b740-08cdf5e96b3a_2ed1aec4-c036-4001-b7b9-cc72ec0cf352.html,Chronic toxicity – systemic effects,oral,NOAEL,"2,250 mg/kg bw/day",,rat Urea,57-13-6,Urea is of very low acute toxicity by all routes investigated. The acute oral LD50 of urea is reported to be 14.3-15.0 g/kg bw in the rat and 11.5-13.0 g/kg bw in the mouse. The acute subcutaneous LD50 is reported to be 8.2-9.4 g/kg bw in the rat and 9.2-10.7 g/kg bw in the mouse. The acute intravenous LD50 of urea is reported to be 5.3-5.4 g/kg bw in the rat and 4.6-5.2 g/kg bw in the mouse. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb3322f7-0ca2-4384-82c7-279e4fc242b0/documents/377d7690-2996-4a5b-a086-c2ed1dc88ad2_2ed1aec4-c036-4001-b7b9-cc72ec0cf352.html,,,,,, Urea,57-13-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb3322f7-0ca2-4384-82c7-279e4fc242b0/documents/377d7690-2996-4a5b-a086-c2ed1dc88ad2_2ed1aec4-c036-4001-b7b9-cc72ec0cf352.html,,oral,LD50,"14,300 mg/kg bw",, Hydrogen peroxide-urea,124-43-6," The read across results indicate that the repeated dose toxicity of hydrogen peroxide – urea (1:1) relies on the toxicity of the breakdown product, hydrogen peroxide, as this is the case for acute toxicity. The lower NOAEL value for male mice (26 mg/kg bw/day) is taken for the calculation of a NOAEL for the target substance (71.8 mg hydrogen peroxide - urea (1:1)/kg bw/d) and derivation of DNEL values. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3015b419-0c39-4e00-a1be-bd65858df7ef/documents/e916ad68-0a3e-4f11-b2df-dfca7f9dbae6_a14e379a-6f05-485e-9885-3128b9516d0c.html,,,,,, Hydrogen peroxide-urea,124-43-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3015b419-0c39-4e00-a1be-bd65858df7ef/documents/e916ad68-0a3e-4f11-b2df-dfca7f9dbae6_a14e379a-6f05-485e-9885-3128b9516d0c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,71.8 mg/kg bw/day,,mouse Hydrogen peroxide-urea,124-43-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3015b419-0c39-4e00-a1be-bd65858df7ef/documents/e916ad68-0a3e-4f11-b2df-dfca7f9dbae6_a14e379a-6f05-485e-9885-3128b9516d0c.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,338.4 mg/kg bw/day,,rat Hydrogen peroxide-urea,124-43-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3015b419-0c39-4e00-a1be-bd65858df7ef/documents/e916ad68-0a3e-4f11-b2df-dfca7f9dbae6_a14e379a-6f05-485e-9885-3128b9516d0c.html,Repeated dose toxicity – local effects,dermal,NOAEL,16.92 mg/cm2,no adverse effect observed,rat Hydrogen peroxide-urea,124-43-6," Based on a study according to OECD Guideline 423 in rats the oral LD50 of the test item was determined to be > 2000 mg/kg bw. As hydrogen peroxide determines the toxicity of the target substance, the estimated dermal LD50 for hydrogen peroxide (source substance) is used to derive an estimate of the dermal LD50 value for the target substance. The dermal LD50 of the target substance was derived to be 13800 mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3015b419-0c39-4e00-a1be-bd65858df7ef/documents/cb66f15f-3d44-468e-ae16-c473f6ffe6bc_a14e379a-6f05-485e-9885-3128b9516d0c.html,,,,,, Hydrogen peroxide-urea,124-43-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3015b419-0c39-4e00-a1be-bd65858df7ef/documents/cb66f15f-3d44-468e-ae16-c473f6ffe6bc_a14e379a-6f05-485e-9885-3128b9516d0c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Hydrogen peroxide-urea,124-43-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3015b419-0c39-4e00-a1be-bd65858df7ef/documents/cb66f15f-3d44-468e-ae16-c473f6ffe6bc_a14e379a-6f05-485e-9885-3128b9516d0c.html,,dermal,LD50,"13,800 mg/kg bw",no adverse effect observed, Ursodeoxycholic acid,128-13-2,The repeated oral toxicity of ursodeoxycholic acid has been evaluated in a 26-week study (1987). No Guideline or followed method is available in the source RTECS. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd82a898-84b8-471f-9d06-a82941fb16bc/documents/76db782b-7e5e-4fc4-9be6-414cd9917144_fab055bd-0166-490f-acac-b05b993b8e57.html,,,,,, Ursodeoxycholic acid,128-13-2,The experimental oral LD50 in rats is 4600 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd82a898-84b8-471f-9d06-a82941fb16bc/documents/aa675675-8e23-4c44-b89f-fa7f402c10b9_fab055bd-0166-490f-acac-b05b993b8e57.html,,,,,, Ursodeoxycholic acid,128-13-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd82a898-84b8-471f-9d06-a82941fb16bc/documents/aa675675-8e23-4c44-b89f-fa7f402c10b9_fab055bd-0166-490f-acac-b05b993b8e57.html,,oral,LD50,"4,600 mg/kg bw",no adverse effect observed, Valeraldehyde,110-62-3,"The oral LD50 of valeraldehyde was determined to be 6490 mg/kg bw in male rats (BASF, 1977).The inhalation LC50 of valeraldehyde was determined to be 14.3 mg/L in rats (Smyth, 1969).The dermal LD50 of valeraldehyde was determined to be 4857 mg/kg in male rabbits (Smyth, 1969). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae0e8fdf-cf4c-47c1-8c23-a3ad7b78a5b9/documents/2e221922-6061-4723-8f7f-1f094560b987_77cb0ad9-369a-4e70-99e9-5799734e70c6.html,,,,,, Valeraldehyde,110-62-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae0e8fdf-cf4c-47c1-8c23-a3ad7b78a5b9/documents/2e221922-6061-4723-8f7f-1f094560b987_77cb0ad9-369a-4e70-99e9-5799734e70c6.html,,oral,LD50,"6,490 mg/kg bw",adverse effect observed, Valeraldehyde,110-62-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae0e8fdf-cf4c-47c1-8c23-a3ad7b78a5b9/documents/2e221922-6061-4723-8f7f-1f094560b987_77cb0ad9-369a-4e70-99e9-5799734e70c6.html,,dermal,LD50,"4,857 mg/kg bw",, Valeraldehyde,110-62-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae0e8fdf-cf4c-47c1-8c23-a3ad7b78a5b9/documents/2e221922-6061-4723-8f7f-1f094560b987_77cb0ad9-369a-4e70-99e9-5799734e70c6.html,,inhalation,LC50,"14,300 mg/m3",adverse effect observed, "2-butyl-4,4,6-trimethyl-1,3-dioxane",54546-26-8,"A study was performed assessing the acute oral toxicity of the test substance in rats. The acute oral LD50 of the test substance was determined to be > 5.0 g/kg bodyweight. The test substance was examined for acute dermal toxicity in albino rabbits. The acute dermal LD50 of the test substance was found to be approximately 5.0 mL/kg body weight, equivalent to 4420 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27ae5479-c3c0-47c4-aef1-e10e052e7dfa/documents/IUC5-34ab250a-c0a7-4b2c-91ad-920eaf881020_6c6ee2ee-b341-4bcd-b9a9-37b71e3e9b01.html,,,,,, "2-butyl-4,4,6-trimethyl-1,3-dioxane",54546-26-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27ae5479-c3c0-47c4-aef1-e10e052e7dfa/documents/IUC5-34ab250a-c0a7-4b2c-91ad-920eaf881020_6c6ee2ee-b341-4bcd-b9a9-37b71e3e9b01.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-butyl-4,4,6-trimethyl-1,3-dioxane",54546-26-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27ae5479-c3c0-47c4-aef1-e10e052e7dfa/documents/IUC5-34ab250a-c0a7-4b2c-91ad-920eaf881020_6c6ee2ee-b341-4bcd-b9a9-37b71e3e9b01.html,,dermal,LD50,"4,420 mg/kg bw",no adverse effect observed, Valeric acid,109-52-4,A 14-day repeated dose dermal study in rabbits and a chronic skin painting study in mice are available for valeric acid. Both studies are considered to be invalid due to severe deficiencies in the methodology. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edb9df2b-784c-49cf-9204-aa679b006b40/documents/IUC5-d98a25bf-7f1e-40bd-af09-51fb5ace0227_16f29a60-696a-4c23-9759-5a4d7ed3c5a6.html,,,,,, Valeric acid,109-52-4,"Several GLP and non-GLP studies according to or similar to OECD guidelines 401, 402 and 403 are available for pure valeric acid and a mixture of valeric acid and 2-methylbutyric acid. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edb9df2b-784c-49cf-9204-aa679b006b40/documents/IUC5-dd9b6636-ab22-422c-8c98-f7a9102c9ed8_16f29a60-696a-4c23-9759-5a4d7ed3c5a6.html,,,,,, Valeric acid,109-52-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edb9df2b-784c-49cf-9204-aa679b006b40/documents/IUC5-dd9b6636-ab22-422c-8c98-f7a9102c9ed8_16f29a60-696a-4c23-9759-5a4d7ed3c5a6.html,,oral,LD50,"4,000 mg/kg bw",, Valeric acid,109-52-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edb9df2b-784c-49cf-9204-aa679b006b40/documents/IUC5-dd9b6636-ab22-422c-8c98-f7a9102c9ed8_16f29a60-696a-4c23-9759-5a4d7ed3c5a6.html,,dermal,LD50,"2,000 mg/kg bw",, L-valine,72-18-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP guideline study with Klimisch Code 1. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c192bc54-97e9-41eb-9622-50a23a38c756/documents/IUC5-88a09b6a-ac32-4f17-b0e9-2dd9b16f988f_8d27fdf9-af57-4c98-b94e-fac7b209b1e9.html,,,,,, L-valine,72-18-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c192bc54-97e9-41eb-9622-50a23a38c756/documents/IUC5-88a09b6a-ac32-4f17-b0e9-2dd9b16f988f_8d27fdf9-af57-4c98-b94e-fac7b209b1e9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,628 mg/kg bw/day,,rat L-valine,72-18-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP guideline study Klimisch Code 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): GLP guideline study Klimisch Code 1 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c192bc54-97e9-41eb-9622-50a23a38c756/documents/IUC5-7367525f-7d71-4ea1-be0b-81e5e22dc4d6_8d27fdf9-af57-4c98-b94e-fac7b209b1e9.html,,,,,, L-valine,72-18-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c192bc54-97e9-41eb-9622-50a23a38c756/documents/IUC5-7367525f-7d71-4ea1-be0b-81e5e22dc4d6_8d27fdf9-af57-4c98-b94e-fac7b209b1e9.html,,oral,LD50,"2,100 mg/kg bw",no adverse effect observed, L-valine,72-18-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c192bc54-97e9-41eb-9622-50a23a38c756/documents/IUC5-7367525f-7d71-4ea1-be0b-81e5e22dc4d6_8d27fdf9-af57-4c98-b94e-fac7b209b1e9.html,,inhalation,LC50,5.26 mg/m3,no adverse effect observed, Vanillin,121-33-5,"In a subchronic study by oral route (Monsanto, 1955, reliability 2) selected as a key study, no effect related to vanillin was observed. Based on this study, the NOAEL determined was 650 mg/kg/day. Other studies by dermal and inhalation route were poorly described and were not taken into account for assessment. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c12ec6d-6346-4933-8d4f-46b14eb57a6e/documents/IUC5-641ab803-b3f8-416e-bc41-40cec0c3f72d_1a248502-8bfe-4b77-9106-3ad70e3e6e37.html,,,,,, Vanillin,121-33-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c12ec6d-6346-4933-8d4f-46b14eb57a6e/documents/IUC5-641ab803-b3f8-416e-bc41-40cec0c3f72d_1a248502-8bfe-4b77-9106-3ad70e3e6e37.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,650 mg/kg bw/day,,rat Vanillin,121-33-5,LD50 oral (rat): 3978 mg/kg bw. Vanilline is not harmful by ingestion according to CLP criteria.LD50 dermal (rat): > 2000 mg/kg bw (no mortality observed at this dose). Vanilline is not harmful by dermal route according to CLP criteria. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c12ec6d-6346-4933-8d4f-46b14eb57a6e/documents/IUC5-1c8e558d-0557-4324-8cbd-12e36129a5a3_1a248502-8bfe-4b77-9106-3ad70e3e6e37.html,,,,,, Vanillin,121-33-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c12ec6d-6346-4933-8d4f-46b14eb57a6e/documents/IUC5-1c8e558d-0557-4324-8cbd-12e36129a5a3_1a248502-8bfe-4b77-9106-3ad70e3e6e37.html,,oral,LD50,"3,978 mg/kg bw",, Vanillin,121-33-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c12ec6d-6346-4933-8d4f-46b14eb57a6e/documents/IUC5-1c8e558d-0557-4324-8cbd-12e36129a5a3_1a248502-8bfe-4b77-9106-3ad70e3e6e37.html,,dermal,LD50,"> 2,000 mg/kg bw",, 4-(butoxymethyl)-2-methoxyphenol,82654-98-6, The oral LD50 in Wistar rats was established as exceeding 2000 mg/kg body weight. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/874d51a2-9f6b-449a-b39e-40b8d12f5c3e/documents/dac6d8a0-d997-414e-aa13-2eb17c721b9d_11c0efa6-d55a-469e-8cc6-49c25e9d55df.html,,,,,, Veratraldehyde,120-14-9,Acute oral toxicity: OECD TG 401: 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0cd19ab0-d3c3-4577-8758-ab9e7b54645f/documents/99d6df30-686b-463d-abae-fe7c7a1ae8ff_0975974a-6387-418a-8427-afffdc9eef76.html,,,,,, "Vetiveria zizanioides, ext.",84238-29-9,"Acute oral toxicity (equivalent to OECD 401, pre-GLP)): LD50>5000 mg/kg bw (limit test)Acute dermal toxicity (equivalent to OECD 402, pre-GLP): LD50>5000 mg/kg bw (limit test) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d78b79a-b118-43a4-b82a-a1bc2ff1b7bb/documents/IUC5-f3f2b436-d85f-4c48-986e-194b2b2cd7dc_7864ac05-f0b0-4880-a57a-4b01b3514805.html,,,,,, "Vetiveria zizanioides, ext.",84238-29-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d78b79a-b118-43a4-b82a-a1bc2ff1b7bb/documents/IUC5-f3f2b436-d85f-4c48-986e-194b2b2cd7dc_7864ac05-f0b0-4880-a57a-4b01b3514805.html,,oral,LD50,"5,000 ",no adverse effect observed, "Vetiveria zizanioides, ext.",84238-29-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d78b79a-b118-43a4-b82a-a1bc2ff1b7bb/documents/IUC5-f3f2b436-d85f-4c48-986e-194b2b2cd7dc_7864ac05-f0b0-4880-a57a-4b01b3514805.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Vinyl acetate,108-05-4," In 90 day oral studies in drinking water in Sprague Dawley rats and CD-1 mice, the NOAEL was 5000 ppm, which was equivalent to 684 mg/kg/day for male rats and 810 mg/kg/day for female rats and equivalent to 285 mg/kg/day for male mice and 281 mg/kg/day for female mice. In the 90 day inhalation studies the NOAEC for systemic effects was 1500 ppm in both rats and mice. For local effects the NOAEC was 50 ppm (176 mg/m³) in mice and 150 ppm (528 mg/m³) in rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07cf68bf-a338-489c-a34d-81de5ff386ed/documents/IUC5-ad89ded0-6fbe-439b-818f-0e90c14acdfc_e2100fd5-8882-48c4-a7c8-0b2347edd579.html,,,,,, Vinyl acetate,108-05-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07cf68bf-a338-489c-a34d-81de5ff386ed/documents/IUC5-ad89ded0-6fbe-439b-818f-0e90c14acdfc_e2100fd5-8882-48c4-a7c8-0b2347edd579.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,281 mg/kg bw/day,, Vinyl acetate,108-05-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07cf68bf-a338-489c-a34d-81de5ff386ed/documents/IUC5-ad89ded0-6fbe-439b-818f-0e90c14acdfc_e2100fd5-8882-48c4-a7c8-0b2347edd579.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,176 mg/m3,, Vinyl acetate,108-05-4," The oral LD50 of vinyl acetate in rats is 3500 mg/kg. A dermal LD50 value of 7440 mg/kg was determined in a study with rabbits. LC50 values of 15810 mg/m3/4 hours and 14084 mg/m3/4 hours were reported for inhalation exposure to rats. (The conversion of ppm to mg/m³ is based on Rm of 86.09, 25 °C, 1 atmosphere.) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07cf68bf-a338-489c-a34d-81de5ff386ed/documents/IUC5-1be08e49-aad3-4853-8b41-8edb8b7ada20_e2100fd5-8882-48c4-a7c8-0b2347edd579.html,,,,,, Vinyl acetate,108-05-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07cf68bf-a338-489c-a34d-81de5ff386ed/documents/IUC5-1be08e49-aad3-4853-8b41-8edb8b7ada20_e2100fd5-8882-48c4-a7c8-0b2347edd579.html,,oral,LD50,"3,500 mg/kg bw",, Vinyl acetate,108-05-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07cf68bf-a338-489c-a34d-81de5ff386ed/documents/IUC5-1be08e49-aad3-4853-8b41-8edb8b7ada20_e2100fd5-8882-48c4-a7c8-0b2347edd579.html,,dermal,LD50,"7,440 mg/kg bw",, Vinyl acetate,108-05-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07cf68bf-a338-489c-a34d-81de5ff386ed/documents/IUC5-1be08e49-aad3-4853-8b41-8edb8b7ada20_e2100fd5-8882-48c4-a7c8-0b2347edd579.html,,inhalation,LC50,"15,810 mg/m3",, Chloroethylene,75-01-4,"In a 6 months inhalation study with rats, an inhalation NOAEC of 50 ppm (130 mg/m3) was established. Exposure to higher concentrations was associated with increased liver weights along with histopathological changes. Comparable studies with other species showed a NOAEC for rabbits of 100 ppm (260 mg/m3, effects on liver) and a NOAEL at the highest level tested, 200 ppm (520 mg/m3), for dogs and guinea pigs.Exposure of rats and mice to 50 ppm (130 mg/m3) for longer periods (10-12 months) is associated with decreased body weight, increased mortality, increased weights of some organs and liver effects.Oral administration of 30 mg vinyl chloride/kg/day in soya oil for 13 weeks or 0.13 mg/kg/day for 149 weeks as PVC powder enriched with vinyl chloride produced no adverse effects in rats. Lifetime oral exposure to vinyl chloride in PVC powder at doses equal to or greater than 1.3 mg/kg/day is toxic to the liver. However, as this route of administration is considered to be not the most appropriate means of conducting an oral toxicity study, the NOAEL for repeated dose toxicity by oral route is considered to be 30 mg/kg bw/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ba8cf5a-edb6-4d1f-ba88-8f00c91c5208/documents/f6501e07-c75e-4470-9838-15bcca487c74_1a17d769-bf5f-4b3d-9b9a-03640ec66dde.html,,,,,, Chloroethylene,75-01-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ba8cf5a-edb6-4d1f-ba88-8f00c91c5208/documents/f6501e07-c75e-4470-9838-15bcca487c74_1a17d769-bf5f-4b3d-9b9a-03640ec66dde.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,, Chloroethylene,75-01-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ba8cf5a-edb6-4d1f-ba88-8f00c91c5208/documents/f6501e07-c75e-4470-9838-15bcca487c74_1a17d769-bf5f-4b3d-9b9a-03640ec66dde.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,130 mg/m3,, Chloroethylene,75-01-4,"The 4 hour LC50 of vinyl chloride in acute inhalation toxicity study with rats was established to be 195,000 mg/m3. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ba8cf5a-edb6-4d1f-ba88-8f00c91c5208/documents/595df576-907d-4dbf-87e5-15dc0fe41340_1a17d769-bf5f-4b3d-9b9a-03640ec66dde.html,,,,,, Chloroethylene,75-01-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ba8cf5a-edb6-4d1f-ba88-8f00c91c5208/documents/595df576-907d-4dbf-87e5-15dc0fe41340_1a17d769-bf5f-4b3d-9b9a-03640ec66dde.html,,inhalation,LC50,"195,000 mg/m3",, "1,1-difluoroethylene",75-38-7," In a chronic toxicity inhalation study, rats were exposed 6 h/d, 5d/week for 24 months at concentrations up to 10000 ppm (26000 mg/m3). This highest concentration tested was considered a NOAEC. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c3e5ca7-c53a-4370-8807-89b4d9847749/documents/IUC5-f8cbb0a6-9ae4-4863-a0f3-a0ffa64d2173_771388e5-3953-4f59-8ec5-b698a31bc2d0.html,,,,,, "1,1-difluoroethylene",75-38-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c3e5ca7-c53a-4370-8807-89b4d9847749/documents/IUC5-f8cbb0a6-9ae4-4863-a0f3-a0ffa64d2173_771388e5-3953-4f59-8ec5-b698a31bc2d0.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"26,000 mg/m3",,rat "1,1-difluoroethylene",75-38-7, The acute inhalation toxicity of vinylidene fluoride is low. The LC50 in rats is established to be >130000 mg/m3. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c3e5ca7-c53a-4370-8807-89b4d9847749/documents/IUC5-061fe437-174f-4048-a696-57277cf0d600_771388e5-3953-4f59-8ec5-b698a31bc2d0.html,,,,,, "1,1-difluoroethylene",75-38-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c3e5ca7-c53a-4370-8807-89b4d9847749/documents/IUC5-061fe437-174f-4048-a696-57277cf0d600_771388e5-3953-4f59-8ec5-b698a31bc2d0.html,,inhalation,LC50,"> 130,000 mg/m3",no adverse effect observed, Triethoxy(vinyl)silane,78-08-0,"Oral: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422), rat: NOAEL (systemic) = 62.5 mg/kg bw/day   Inhalation: RA CAS 2768-02-7 Subchronic Inhalation Toxicity 90-Day Study (OECD 413), rat: NOAEC (systemic) = 100 ppm (equivalent to 605 mg/m³ air) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea7aaab1-1078-4819-9729-3418f4f0d925/documents/39bc422d-1631-4567-b8ec-c43fda30ebb7_b1d9f5fc-035e-49dc-8708-ddef17367ece.html,,,,,, Triethoxy(vinyl)silane,78-08-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea7aaab1-1078-4819-9729-3418f4f0d925/documents/39bc422d-1631-4567-b8ec-c43fda30ebb7_b1d9f5fc-035e-49dc-8708-ddef17367ece.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,62.5 mg/kg bw/day,,rat Triethoxy(vinyl)silane,78-08-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea7aaab1-1078-4819-9729-3418f4f0d925/documents/39bc422d-1631-4567-b8ec-c43fda30ebb7_b1d9f5fc-035e-49dc-8708-ddef17367ece.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,605 mg/m3,,rat Triethoxy(vinyl)silane,78-08-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea7aaab1-1078-4819-9729-3418f4f0d925/documents/39bc422d-1631-4567-b8ec-c43fda30ebb7_b1d9f5fc-035e-49dc-8708-ddef17367ece.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"2,421 mg/m3",no adverse effect observed,rat Triethoxy(vinyl)silane,78-08-0,"Oral (OECD 401), rat: LD50 >5000 mg/kg bwDermal (OECD 402), rat: LD50 >2000 mg/kg bw (limit test)Inhalation: only RL4 studies available, LC50 = 4500 ppm (34976 mg/m³) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea7aaab1-1078-4819-9729-3418f4f0d925/documents/4a23c58d-75d0-4549-afed-603fa1587ee6_b1d9f5fc-035e-49dc-8708-ddef17367ece.html,,,,,, "Purine-2(3H),6(1H)-dione",69-89-6,"Oral: OECD Guideline 425; rat LD50 >2000 mg/kg. Reliability = 1 Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Guideline, GLP study ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a5b0173-dc1c-4653-95e7-312669202602/documents/1ed70c33-ce5b-425f-abb8-6a28e3769c63_e713ab22-5a37-4e46-b903-33e960085fb9.html,,,,,, "Purine-2(3H),6(1H)-dione",69-89-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a5b0173-dc1c-4653-95e7-312669202602/documents/1ed70c33-ce5b-425f-abb8-6a28e3769c63_e713ab22-5a37-4e46-b903-33e960085fb9.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Xylene,1330-20-7," In repeated dose studies, the principle effects of xylenes were adaptive changes in the liver, organ weight and body weight changes. Inhalation studies in rodents have demonstrated a potential to cause ototoxicity.   The repeated exposure toxicity of ethylbenzene has been evaluated in animals in subchronic and chronic inhalation studies, subchronic oral toxicity studies and numerous specialized investigations. Overall, ethylbenzene poses a moderate repeated exposure toxicity hazard with consistent targeted effects to the liver, kidney and hearing. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fbb5256-8fb7-4ae9-b5ca-23e149387dba/documents/4e894732-9fa4-4bf4-aab5-6051af93ae1e_1114b88c-79a0-4645-87f9-fed71443a231.html,,,,,, Xylene,1330-20-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fbb5256-8fb7-4ae9-b5ca-23e149387dba/documents/4e894732-9fa4-4bf4-aab5-6051af93ae1e_1114b88c-79a0-4645-87f9-fed71443a231.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"3,515 mg/m3",,rat Xylene,1330-20-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fbb5256-8fb7-4ae9-b5ca-23e149387dba/documents/4e894732-9fa4-4bf4-aab5-6051af93ae1e_1114b88c-79a0-4645-87f9-fed71443a231.html,Chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Xylene,1330-20-7,"In animal studies xylene isomers (including mixed xylene) exhibit low acute toxicity by oral and dermal routes with the reported LD50 values all exceeding 2000 mg/kg bw. Mixed xylene is considered harmful by inhalation.In humans critical effects of xylenes are irritation and CNS effects, with the overall NOAEC inhalation for the latter effect being 300 mg/m3. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fbb5256-8fb7-4ae9-b5ca-23e149387dba/documents/8e2b6f21-a8f5-45fd-970e-64ef9d1a647d_1114b88c-79a0-4645-87f9-fed71443a231.html,,,,,, Xylene,1330-20-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fbb5256-8fb7-4ae9-b5ca-23e149387dba/documents/8e2b6f21-a8f5-45fd-970e-64ef9d1a647d_1114b88c-79a0-4645-87f9-fed71443a231.html,,oral,LD50,"3,523 mg/kg bw",no adverse effect observed, Xylene,1330-20-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fbb5256-8fb7-4ae9-b5ca-23e149387dba/documents/8e2b6f21-a8f5-45fd-970e-64ef9d1a647d_1114b88c-79a0-4645-87f9-fed71443a231.html,,dermal,LD50,"12,126 mg/kg bw",adverse effect observed, Xylene,1330-20-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fbb5256-8fb7-4ae9-b5ca-23e149387dba/documents/8e2b6f21-a8f5-45fd-970e-64ef9d1a647d_1114b88c-79a0-4645-87f9-fed71443a231.html,,inhalation,LC50,"27,124 mg/m3",adverse effect observed, o-xylene,95-47-6,"In repeated dose studies, the principle effects of xylenes were adaptive changes in the liver, organ weight and body weight changes. Inhalation studies in rodents have demonstrated a potential to cause ototoxicity. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73af0f94-a98d-4811-a75a-80716a39a4a3/documents/c0b82c10-164a-4691-8e0a-abf8536bdfd7_af985997-3fda-4673-86ff-1638176889a6.html,,,,,, o-xylene,95-47-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73af0f94-a98d-4811-a75a-80716a39a4a3/documents/c0b82c10-164a-4691-8e0a-abf8536bdfd7_af985997-3fda-4673-86ff-1638176889a6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,ca.300 mg/kg bw/day,,rat o-xylene,95-47-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73af0f94-a98d-4811-a75a-80716a39a4a3/documents/c0b82c10-164a-4691-8e0a-abf8536bdfd7_af985997-3fda-4673-86ff-1638176889a6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat o-xylene,95-47-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73af0f94-a98d-4811-a75a-80716a39a4a3/documents/c0b82c10-164a-4691-8e0a-abf8536bdfd7_af985997-3fda-4673-86ff-1638176889a6.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"3,515 mg/m3",,rat o-xylene,95-47-6,"In animal studies xylenes exhibit low acute toxicity by oral (LD50 3,523 mg/kg), inhalation (4h LC50 27,124 mg/m3) and dermal (LD50 12,126 mg/kg) routes. In humans critical effects are irritation and CNS effects. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73af0f94-a98d-4811-a75a-80716a39a4a3/documents/180b3b4e-5af2-4c35-943b-f2961be35b1c_af985997-3fda-4673-86ff-1638176889a6.html,,,,,, o-xylene,95-47-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73af0f94-a98d-4811-a75a-80716a39a4a3/documents/180b3b4e-5af2-4c35-943b-f2961be35b1c_af985997-3fda-4673-86ff-1638176889a6.html,,oral,LD50,"3,523 mg/kg bw",no adverse effect observed, o-xylene,95-47-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73af0f94-a98d-4811-a75a-80716a39a4a3/documents/180b3b4e-5af2-4c35-943b-f2961be35b1c_af985997-3fda-4673-86ff-1638176889a6.html,,dermal,LD50,"12,126 mg/kg bw",adverse effect observed, o-xylene,95-47-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73af0f94-a98d-4811-a75a-80716a39a4a3/documents/180b3b4e-5af2-4c35-943b-f2961be35b1c_af985997-3fda-4673-86ff-1638176889a6.html,,inhalation,LC50,"27,124 mg/m3",adverse effect observed, m-xylene,108-38-3,"In repeated dose studies, the principle effects of xylenes were adaptive changes in the liver, organ weight and body weight changes. Inhalation studies in rodents have demonstrated a potential to cause ototoxicity.  ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4230dca-7abb-4675-b803-19046f028caa/documents/c0b82c10-164a-4691-8e0a-abf8536bdfd7_457a7c82-235a-49cc-89d7-6afa0e01d343.html,,,,,, m-xylene,108-38-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4230dca-7abb-4675-b803-19046f028caa/documents/c0b82c10-164a-4691-8e0a-abf8536bdfd7_457a7c82-235a-49cc-89d7-6afa0e01d343.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat m-xylene,108-38-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4230dca-7abb-4675-b803-19046f028caa/documents/c0b82c10-164a-4691-8e0a-abf8536bdfd7_457a7c82-235a-49cc-89d7-6afa0e01d343.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"3,515 mg/m3",,rat m-xylene,108-38-3," In animal studies xylenes exhibit low acute toxicity by oral (LD50 3,523 mg/kg), inhalation (4h LC50 27,124 mg/m3) and dermal (LD50 12,126 mg/kg) routes. In humans critical effects are irritation and CNS effects. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4230dca-7abb-4675-b803-19046f028caa/documents/180b3b4e-5af2-4c35-943b-f2961be35b1c_457a7c82-235a-49cc-89d7-6afa0e01d343.html,,,,,, m-xylene,108-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4230dca-7abb-4675-b803-19046f028caa/documents/180b3b4e-5af2-4c35-943b-f2961be35b1c_457a7c82-235a-49cc-89d7-6afa0e01d343.html,,oral,LD50,"3,523 mg/kg bw",no adverse effect observed, m-xylene,108-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4230dca-7abb-4675-b803-19046f028caa/documents/180b3b4e-5af2-4c35-943b-f2961be35b1c_457a7c82-235a-49cc-89d7-6afa0e01d343.html,,dermal,LD50,"12,126 mg/kg bw",adverse effect observed, m-xylene,108-38-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4230dca-7abb-4675-b803-19046f028caa/documents/180b3b4e-5af2-4c35-943b-f2961be35b1c_457a7c82-235a-49cc-89d7-6afa0e01d343.html,,inhalation,LC50,"27,124 mg/m3",adverse effect observed, "1,3-bis(isocyanatomethyl)benzene",3634-83-1," In an OECD 422 study, rats were exposed orally (gavage) to XDI up to 200 mg/kg bw/day for approx 42 days. In a sub-chronic (90-d) inhalation toxicity study in rats according to OECD413 with the read across substance NBDI, rats were exposed up to 2.03 mg/m3. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70274cab-da93-416f-99ab-d7d5ae76902c/documents/IUC5-dfc99d7d-c98c-45b8-820b-c9d48b469138_3d461091-86c7-4f63-9e11-9dbd7334a4c9.html,,,,,, "1,3-bis(isocyanatomethyl)benzene",3634-83-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70274cab-da93-416f-99ab-d7d5ae76902c/documents/IUC5-dfc99d7d-c98c-45b8-820b-c9d48b469138_3d461091-86c7-4f63-9e11-9dbd7334a4c9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "1,3-bis(isocyanatomethyl)benzene",3634-83-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70274cab-da93-416f-99ab-d7d5ae76902c/documents/IUC5-dfc99d7d-c98c-45b8-820b-c9d48b469138_3d461091-86c7-4f63-9e11-9dbd7334a4c9.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,2.03 mg/m3,,rat "1,3-bis(isocyanatomethyl)benzene",3634-83-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70274cab-da93-416f-99ab-d7d5ae76902c/documents/IUC5-dfc99d7d-c98c-45b8-820b-c9d48b469138_3d461091-86c7-4f63-9e11-9dbd7334a4c9.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.12 mg/m3,adverse effect observed,rat "1,3-bis(isocyanatomethyl)benzene",3634-83-1,"For all three routes, guideline studies are available resulting in a LD50 (oral) of 3200 mg/kg bw, a LD50 (dermal) of >2000 mg/kg bw and a 4h-LC50 of 175 mg/m3. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70274cab-da93-416f-99ab-d7d5ae76902c/documents/IUC5-852521fe-637a-4857-9b8f-6804ce6defc6_3d461091-86c7-4f63-9e11-9dbd7334a4c9.html,,,,,, "1,3-bis(isocyanatomethyl)benzene",3634-83-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70274cab-da93-416f-99ab-d7d5ae76902c/documents/IUC5-852521fe-637a-4857-9b8f-6804ce6defc6_3d461091-86c7-4f63-9e11-9dbd7334a4c9.html,,oral,LD50,"3,200 mg/kg bw",adverse effect observed, "1,3-bis(isocyanatomethyl)benzene",3634-83-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70274cab-da93-416f-99ab-d7d5ae76902c/documents/IUC5-852521fe-637a-4857-9b8f-6804ce6defc6_3d461091-86c7-4f63-9e11-9dbd7334a4c9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3-bis(isocyanatomethyl)benzene",3634-83-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70274cab-da93-416f-99ab-d7d5ae76902c/documents/IUC5-852521fe-637a-4857-9b8f-6804ce6defc6_3d461091-86c7-4f63-9e11-9dbd7334a4c9.html,,inhalation,LC50,175 mg/m3,adverse effect observed, Xylitol,87-99-0, 3-Week feeding study; rat; NOAEL: 20000 mg/kg (highest dose tested). Reliability = 2 ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed79c45b-28dc-45de-81b9-59b8865df864/documents/5e50bf9b-75ac-4d05-98e0-c950312db32f_a09bcb58-06dd-4ebf-8d93-829c0b423aeb.html,,,,,, Xylitol,87-99-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed79c45b-28dc-45de-81b9-59b8865df864/documents/5e50bf9b-75ac-4d05-98e0-c950312db32f_a09bcb58-06dd-4ebf-8d93-829c0b423aeb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"20,000 mg/kg bw/day",,rat Xylitol,87-99-0, Oral: rat and mouse LD50 4000 mg/kg. Reliability = 2 Inhalation: No study available Dermal: No study available ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed79c45b-28dc-45de-81b9-59b8865df864/documents/cd23fdbb-f352-439e-836a-d90bae7a69b2_a09bcb58-06dd-4ebf-8d93-829c0b423aeb.html,,,,,, Xylitol,87-99-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed79c45b-28dc-45de-81b9-59b8865df864/documents/cd23fdbb-f352-439e-836a-d90bae7a69b2_a09bcb58-06dd-4ebf-8d93-829c0b423aeb.html,,oral,LD50,"4,000 mg/kg bw",no adverse effect observed, Xylose,58-86-6," 104 week feeding study; rat; NOAEL > 5% (highest dose tested; equivalent to 2214 and 2513 mg/kg in males and females, respectively); reliability = 2 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/417704c2-eec7-4ceb-9f10-fdcacc1570d5/documents/IUC5-81bffcad-5d2d-4e52-a073-d31425bd2be8_180218c8-3b17-4585-9d38-6922964bc0e8.html,,,,,, Xylose,58-86-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/417704c2-eec7-4ceb-9f10-fdcacc1570d5/documents/IUC5-81bffcad-5d2d-4e52-a073-d31425bd2be8_180218c8-3b17-4585-9d38-6922964bc0e8.html,Chronic toxicity – systemic effects,oral,NOAEL,"2,513 mg/kg bw/day",,rat Xylose,58-86-6, oral: Japan MHLW Guideline; LD50 > 2200 mg/kg bw (male rat) ; LD50 > 2500 mg/kg (female rat); reliability = 2 ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/417704c2-eec7-4ceb-9f10-fdcacc1570d5/documents/IUC5-fe5f99c2-f0fb-42e1-b4d8-18dbe25ad37c_180218c8-3b17-4585-9d38-6922964bc0e8.html,,,,,, Xylose,58-86-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/417704c2-eec7-4ceb-9f10-fdcacc1570d5/documents/IUC5-fe5f99c2-f0fb-42e1-b4d8-18dbe25ad37c_180218c8-3b17-4585-9d38-6922964bc0e8.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "Zeolite, cuboidal, crystalline, synthetic, non-fibrous",1318-02-1,"Oral There are three reliable key studies available. The first in a type A zeolite has a NOAEL of c. 102.9 mg/kg bw/d and a LOAEL of c. 412.4 mg/kg bw/d. Both values are above the GHS threshold levels. The second, also in a type A zeolite, is the most critical with a NOAEL of c. 75.1 mg/kg bw/d and a LOAEL of c. 1250.8 mg/kg bw/d. Although the former value is within the classification limits of GHS, the last is high above them. As the GHS classification system is based on the lowest value at which actual adverse effects are recognised, there is no need for classification, because this value is somewhere between 75.1 and 1250.8 mg/kg bw/d. The low NOAEL derived in this study is probably simply due to the fact that no intermediate dose levels were tested. This is also in accordance with the results of the third key study, again in a type A zeolite, with a NOAEL of c. 292 mg/kg bw/d and a LOAEL 577 mg/kg bw/d. In summary, it can be assumed that the actual LOAEL of zeolites is greater than 292 and less than 412 mg/kg bw/d. Also, a NOAEL of 292 mg/kg bw/d can be used for classification, because in no study any adverse effects were observed below this level and in one this value was established as a NOAEL.   Inhalation There are two reliable studies available in a type A zeolite. In both studies, in hamsters and rats, a NOAEL of equal or greater than 20 mg/m³ was assessed. There was no evidence of fibrotic disease or silicotic changes of or carcinogenic effects to the internal organs after inhalation of the type A zeolite. It was also examined whether that substance got into the lower respiratory system of the experimental animals. According to this study, the presence of silicium in the lungs of rats after inhalation could be considered as evident. But macroscopically no changes in the internal organs nor deviations from the controls were observed.    Dermal There is no study in repeated dermal toxicity available, but an expert's weight-of-evidence approach concludes that dermal exposure to conventional zeolites did not raise safety concerns with regard to systemic toxicity, and new animal testing was not supported both from an animal welfare perspective and from the fact that there would be no new knowledge gain from such experiment.  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): reliability 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): reliability 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reiliability 1 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6eea0d44-6774-4ef8-9d84-3270f35dab49/documents/5752ee95-46b4-4d5c-a512-2e95c77af099_43adf20f-bf8d-4903-a55b-1d4f5409ffbd.html,,,,,, "Zeolite, cuboidal, crystalline, synthetic, non-fibrous",1318-02-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6eea0d44-6774-4ef8-9d84-3270f35dab49/documents/5752ee95-46b4-4d5c-a512-2e95c77af099_43adf20f-bf8d-4903-a55b-1d4f5409ffbd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,292 mg/kg bw/day,,rat "Zeolite, cuboidal, crystalline, synthetic, non-fibrous",1318-02-1,"OralIn the two reliable studies neither mortality nor any signs of clinical poisoning were observed.   Inhalation In the key study with crystalline aluminosilicate no signs of toxicity were observed up to 18.3 mg/l during the exposure or the fourteen day observation period. In the supporting study in a type A zeolite, all of the compounds tested appeared to produce an increased incidence of pulmonary abnormalities such as areas of hemorrhage and atelectasis, but these effects were not attributed to specific substances (like type A zeolite). Further, generally their incidence was considered to be slight to moderate. At least, there was no mortality observed. Also, as supporting information: An in-vitro alveolar macrophage assay (used for predicting the acute toxicity of nanomaterials) showed that the effects of the four types of zeolites were heterogeneous and comparatively low when compared to natural aluminosilicates such as bentonite or kaolin studied with the same experimental setup (s.a. IUCLID 7.9.4)   DermalIn the only reliable study neither mortality nor any signs of clinical poisoning were observed. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6eea0d44-6774-4ef8-9d84-3270f35dab49/documents/93435620-946e-45e9-a322-2d83f456fa07_43adf20f-bf8d-4903-a55b-1d4f5409ffbd.html,,,,,, Zinc,7440-66-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): guideline studies available ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2d9b11c-d84f-4f16-976e-57fb2d16463d/documents/d3dbfe8d-29df-4047-bae7-35d291fdb315_07b48ac7-0dc0-4df3-aeea-ddce076d40f6.html,,,,,, Zinc,7440-66-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2d9b11c-d84f-4f16-976e-57fb2d16463d/documents/d3dbfe8d-29df-4047-bae7-35d291fdb315_07b48ac7-0dc0-4df3-aeea-ddce076d40f6.html,Repeated dose toxicity – local effects,inhalation,BMCL10,0.971 mg/m3,adverse effect observed,rat Zinc,7440-66-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2d9b11c-d84f-4f16-976e-57fb2d16463d/documents/IUC5-be8d1fa2-dd1b-4d66-a98a-05ffb72b824a_07b48ac7-0dc0-4df3-aeea-ddce076d40f6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Zinc,7440-66-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2d9b11c-d84f-4f16-976e-57fb2d16463d/documents/IUC5-be8d1fa2-dd1b-4d66-a98a-05ffb72b824a_07b48ac7-0dc0-4df3-aeea-ddce076d40f6.html,,inhalation,LC50,"5,410 mg/m3",no adverse effect observed, Zinc di(acetate),557-34-6,Repeated dose toxicity: oral: Key study: The NOEL for Zinc acetate anhydrous was 133.77 mg/kg bw/day in female rats (test method similar to OECD guideline 408). ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91b1c2f5-4ed1-4d50-8401-d55d77e4e4ec/documents/IUC5-51173c38-4dd0-4b16-9700-79c048873485_2a84961a-c340-41c7-8b14-6b6ffd16f79e.html,,,,,, Zinc di(acetate),557-34-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91b1c2f5-4ed1-4d50-8401-d55d77e4e4ec/documents/IUC5-51173c38-4dd0-4b16-9700-79c048873485_2a84961a-c340-41c7-8b14-6b6ffd16f79e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,133.77 mg/kg bw/day,,rat Zinc di(acetate),557-34-6,"Acute toxicity: oral: Weight of evidence: The estimated LD50 for Zinc Acetate anhydrous was 663.83-2460 mg/kg bw in rats, and it was 239.95 mg/kg bw in mice. Mice were more sensitive than rats. Test method similar to OECD guideline 423.Acute toxicity: inhalation: Weight of evidence: The estimated LC50 for Zinc Acetate was between 6.49 and 58.04 mg/L. Read-across approach from experimental data on analogues Calcium Acetate and Zinc Stearate.Acute toxicity: other routes: Supporting information: The LD50 for adult mice was 42 mg/kg bw, and for juvenile mice was 97.8-99.6 mg/kg bw. The LD50 of zinc acetate anhydrous was 90.29 (56.02 -229.91) mg/kg bw in male mice, and 135.44 (74.41 -244.13) mg/kg bw in male rats. Mice were more sensitive than rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91b1c2f5-4ed1-4d50-8401-d55d77e4e4ec/documents/IUC5-045b3966-7bc8-44b2-b87c-de6137f8ecb2_2a84961a-c340-41c7-8b14-6b6ffd16f79e.html,,,,,, Zinc di(acetate),557-34-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91b1c2f5-4ed1-4d50-8401-d55d77e4e4ec/documents/IUC5-045b3966-7bc8-44b2-b87c-de6137f8ecb2_2a84961a-c340-41c7-8b14-6b6ffd16f79e.html,,oral,LD50,663.83 mg/kg bw,adverse effect observed, Zinc di(acetate),557-34-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91b1c2f5-4ed1-4d50-8401-d55d77e4e4ec/documents/IUC5-045b3966-7bc8-44b2-b87c-de6137f8ecb2_2a84961a-c340-41c7-8b14-6b6ffd16f79e.html,,inhalation,LC50,"6,490 mg/m3",no adverse effect observed, "Boric acid, zinc salt",1332-07-6,"1) 28-day sub-acute study on zinc borate (hydrate) was carried out in rats (Wragg et al 1996);2) 90-day repeated dose study of zinc borate heptahydrate, rats, oral gavage, NOAEL 100 mg/kg bw (males), 375 mg/kg bw (females), (Kirkpatrick, 2014);3) Allen et al., 1996: BMD of 59 mg of Boric acid/kg bw (equivalent to 10.3 mg Boron/kg bw) was calculated;4) repeated dose inhalation toxicity of zinc oxide (Placke, 1990);5) subacute repeated dose inhalation toxicity of aerosolized zinc borate heptahydrate in rats, a minimum of ten exposures (Randazzo, 2014) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f28eb548-7367-4d6e-87df-97a588466deb/documents/cdb1ccf1-9924-4a00-bb2e-b5b263b192fa_8acca94f-17c9-4244-90b8-e8eca8eba649.html,,,,,, "Boric acid, zinc salt",1332-07-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f28eb548-7367-4d6e-87df-97a588466deb/documents/cdb1ccf1-9924-4a00-bb2e-b5b263b192fa_8acca94f-17c9-4244-90b8-e8eca8eba649.html,Short-term repeated dose toxicity – systemic effects,oral,BMDL05,10.3 mg/kg bw/day,,rat "Boric acid, zinc salt",1332-07-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f28eb548-7367-4d6e-87df-97a588466deb/documents/cdb1ccf1-9924-4a00-bb2e-b5b263b192fa_8acca94f-17c9-4244-90b8-e8eca8eba649.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,127.1 mg/m3,,rat "Boric acid, zinc salt",1332-07-6," Acute oral and dermal studies have been performed with zinc borate anhydrous and the heptahydrate. In addition, acute oral, dermal and inhalation studies on an analogue substance have been performed. Experimental data showed low acute toxicity to zinc borate. The mean of the male and female values were obtained from the key study (oral route; Kreuzmann, 1990). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f28eb548-7367-4d6e-87df-97a588466deb/documents/f54323f9-72ff-4120-a549-634f8413c1b0_8acca94f-17c9-4244-90b8-e8eca8eba649.html,,,,,, "Boric acid, zinc salt",1332-07-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f28eb548-7367-4d6e-87df-97a588466deb/documents/f54323f9-72ff-4120-a549-634f8413c1b0_8acca94f-17c9-4244-90b8-e8eca8eba649.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Boric acid, zinc salt",1332-07-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f28eb548-7367-4d6e-87df-97a588466deb/documents/f54323f9-72ff-4120-a549-634f8413c1b0_8acca94f-17c9-4244-90b8-e8eca8eba649.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Boric acid, zinc salt",1332-07-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f28eb548-7367-4d6e-87df-97a588466deb/documents/f54323f9-72ff-4120-a549-634f8413c1b0_8acca94f-17c9-4244-90b8-e8eca8eba649.html,,inhalation,LC50,4.95 mg/m3,no adverse effect observed, Zinc chloride,7646-85-7,"Animal data Oral: The repeated dose toxicity of the zinc category substances has been examined in a number of sub-chronic oral repeated dose toxictiy studies. The NOAEL for systemic effects of the zinc category substances was determined to be 25 mg Zn/kg bw/day, derived in an oral 90-day study with nano zinc oxide in rats. Inhalation: The repeated dose inhalation toxicity of micro and nano-ZnO has been examined respectively in a subacute (28 days) and two subchronic (90 days) inhalation studies. The lowest NOAEC was determined to be 0.47 mg/m³ (target concentration: 0.5 mg/m³) for micro ZnO. For nano-ZnO the BMCL10 was determined to be 0.971 mg/m³. Dermal: No adverse effects were observed in a 90-day repeated dose toxicity study via the dermal route with nano-ZnO. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): guideline studies available ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce9d70d2-2662-4e9b-a0f4-1d986eb03694/documents/d3dbfe8d-29df-4047-bae7-35d291fdb315_6939cd75-0ec4-466f-87f1-bdf471e6e538.html,,,,,, Zinc chloride,7646-85-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce9d70d2-2662-4e9b-a0f4-1d986eb03694/documents/d3dbfe8d-29df-4047-bae7-35d291fdb315_6939cd75-0ec4-466f-87f1-bdf471e6e538.html,Repeated dose toxicity – local effects,inhalation,BMCL10,0.971 mg/m3,adverse effect observed,rat Zinc chloride,7646-85-7,"Assessment of the acute oral toxicity of zinc chloride was studied in Sprague-Dawley rats and Swiss mouse according to OECD guideline no 401 .The LD50 value was within the range of 1,100 to 1,260 mg/kg bw. In the 10 min inhalation study in female Sprague-Dawley rats, zinc chloride has demonstrated acute toxicity via the inhalation route (LC50 ≤ 1,975 mg/m3). However, since the exposure of the animals to the size of the particles is not truly representative of exposure to humans under normal conditions, it is difficult to assess whether or not, zinc chloride is acutely toxic since a four hour LC50 value could not be derived and a clear dose-response relationhip coud not be established. Airway irritation has been observed both in animals and in humans, zinc chloride has the potential to be a respiratory tract irritant.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce9d70d2-2662-4e9b-a0f4-1d986eb03694/documents/IUC5-bdd9f5bd-cafd-4b61-9db6-8ded31a19e36_6939cd75-0ec4-466f-87f1-bdf471e6e538.html,,,,,, Zinc chloride,7646-85-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce9d70d2-2662-4e9b-a0f4-1d986eb03694/documents/IUC5-bdd9f5bd-cafd-4b61-9db6-8ded31a19e36_6939cd75-0ec4-466f-87f1-bdf471e6e538.html,,oral,LD50,"1,100 mg/kg bw",adverse effect observed, Zinc chloride,7646-85-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce9d70d2-2662-4e9b-a0f4-1d986eb03694/documents/IUC5-bdd9f5bd-cafd-4b61-9db6-8ded31a19e36_6939cd75-0ec4-466f-87f1-bdf471e6e538.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Zinc chloride,7646-85-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce9d70d2-2662-4e9b-a0f4-1d986eb03694/documents/IUC5-bdd9f5bd-cafd-4b61-9db6-8ded31a19e36_6939cd75-0ec4-466f-87f1-bdf471e6e538.html,,inhalation,LC50,"1,975 mg/m3",adverse effect observed, Trizinc dicitrate,546-46-3," ZINC (13 wk) NOAEL 234 mg ZnSO4.7H2O/kg bw rats (approximately 53.5 mg Zn2+/kg bw or 155 mg trizinc dicitrate/kg (bw)*) (Maita et al., 1981; rel 2) (13 wk) NOAEL = 469 mg ZnSO4.7H2O/kg bw rats (approximately 104 mg Zn2+/kg bw or 302 mg trizinc dicitrate/kg (bw)*). (Maita et al., 1981, rel. 2). CITRIC ACID (5 d) NOAEL 4000 mg/kg, rats (Bachtold1976; rel 2) (10 d) NOAEL (mortality) values of 1000 and 4000 mg/kg, mice and rats respectively (Bachtold 1978, rel. 2) For DNEL derivation human data (listed under IUCLID chapter 7.10.3) are used with a 10 week NOAEL of approx. 50 mg Zn2 +/person/d based on a depressed copper uptake and an altered lipid profile in humans. This section contains substantially new data. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2d1cd91-edfd-479c-9334-d3e9bcaa8c00/documents/b21b9a17-4abb-4540-aa45-fd880fa2ab35_92a55ba7-d956-4228-8a4b-5e26dad44f13.html,,,,,, Trizinc dicitrate,546-46-3,"The key acute oral study reports an LD50 value of >2000mg/kg (Safepharm 1991; rel 1). The only available key study for dermal toxicity was read across from citric acid, which reports an LD50 value of 2000mg/kg (Safepharm, 2006; rel 1). Weight of evidence from other zinc metals (zinc distearate and zinc sulphate) support the key findings (EU RAR, 2008; rel 2). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2d1cd91-edfd-479c-9334-d3e9bcaa8c00/documents/IUC5-777e45fb-e8b9-475e-9e5f-ba372bd3d5a0_92a55ba7-d956-4228-8a4b-5e26dad44f13.html,,,,,, Trizinc dicitrate,546-46-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2d1cd91-edfd-479c-9334-d3e9bcaa8c00/documents/IUC5-777e45fb-e8b9-475e-9e5f-ba372bd3d5a0_92a55ba7-d956-4228-8a4b-5e26dad44f13.html,,oral,LD50,"2,000 mg/kg bw",, Trizinc dicitrate,546-46-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2d1cd91-edfd-479c-9334-d3e9bcaa8c00/documents/IUC5-777e45fb-e8b9-475e-9e5f-ba372bd3d5a0_92a55ba7-d956-4228-8a4b-5e26dad44f13.html,,dermal,LD50,"2,000 mg/kg bw",, Zinc bis(dibutyldithiocarbamate),136-23-2," - In this GLP complaint oral repeated dose toxicity study, performed according to OECD 408, the no-observed-adverse-effect level (NOAEL) is conservatively placed at the lowest level tested (10 mg/kg body weight/day) based on increased liver and kidney weight in combination with effects on total protein and albumin in the mid-dose group (males). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4c39c3c-637a-46b1-a271-0a14ec9433ce/documents/IUC5-2cc5ef3f-2b3f-4f60-808d-5150a960b485_f8a58ffe-67cf-47c3-9f10-a3613a4c86b9.html,,,,,, Zinc bis(dibutyldithiocarbamate),136-23-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4c39c3c-637a-46b1-a271-0a14ec9433ce/documents/IUC5-2cc5ef3f-2b3f-4f60-808d-5150a960b485_f8a58ffe-67cf-47c3-9f10-a3613a4c86b9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Zinc bis(dibutyldithiocarbamate),136-23-2,"Acute toxicity of zinc bis(dibutyldithiocarbamate) (ZDBC) by oral and dermal exposure routes is low. Several acute oral toxicity studies give oral LD50 value over 5000 mg/kg bw for rats, while two acute dermal toxicity studies with rabbits give LD50 > 2000 mg/kg bw/day. No data on acute inhalation toxicity were available; however, in accordance with REACH Annex VIII, the study does not need to be conducted, as data on two other routes of exposure are available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4c39c3c-637a-46b1-a271-0a14ec9433ce/documents/IUC5-496d0760-8164-45aa-a846-9ea3a0d395ce_f8a58ffe-67cf-47c3-9f10-a3613a4c86b9.html,,,,,, Zinc bis(dibutyldithiocarbamate),136-23-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4c39c3c-637a-46b1-a271-0a14ec9433ce/documents/IUC5-496d0760-8164-45aa-a846-9ea3a0d395ce_f8a58ffe-67cf-47c3-9f10-a3613a4c86b9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Zinc bis(dibutyldithiocarbamate),136-23-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4c39c3c-637a-46b1-a271-0a14ec9433ce/documents/IUC5-496d0760-8164-45aa-a846-9ea3a0d395ce_f8a58ffe-67cf-47c3-9f10-a3613a4c86b9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Zinc bis(2-ethylhexanoate),136-53-8," No repeated dose toxicity study with zinc bis(2-ethylhexanoate) is available. In the assessment of toxicity of zinc bis(2-ethylhexanoate), read-across to the assessment entities zinc and 2-ethylhexanoic acid is applied since the ions of zinc bis(2-ethylhexanoate) determine its toxicity in biological compartments. In relevant and reliable repeated dose toxicity studies for both moieties of zinc bis(2-ethylhexanoate), there were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa3b606d-a40e-4b5d-bf69-b27cb115675d/documents/71aedac2-73f8-4c1c-b5ee-5b7c433101c0_2c40b162-b35e-4210-be49-f985a0de3731.html,,,,,, Zinc bis(2-ethylhexanoate),136-53-8," No acute toxicity studies with zinc bis(2-ethylhexanoate) are available. In the assessment of toxicity of zinc bis(2-ethylhexanoate), read-across to the assessment entities zinc and 2-ethylhexanoic acid is applied since the ions of zinc bis(2-ethylhexanoate) determine its toxicity in biological compartments. Signs of acute oral or acute dermal toxicity are not expected for zinc bis(2-ethylhexanoate), since its two moieties zinc and 2-ethylhexanoic acid have not shown signs of acute oral or acute dermal toxicity in experimental testing (both LD50 > 2000mg/kg). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa3b606d-a40e-4b5d-bf69-b27cb115675d/documents/a0cee87b-820f-4574-bfe9-edf6e31f0cfa_2c40b162-b35e-4210-be49-f985a0de3731.html,,,,,, Zinc bis(hydroxymethanesulphinate),24887-06-7,"Non-human informationThe repeated dose toxicity of water soluble zinc sulphate and zinc monoglycerolate has been examined in a total of 3 subchronic oral feeding studies. Due to the different dosing regimens, the lowest NOAEL was determined to be 31.5 mg/kg bw/day of zinc monoglycerolate which equals a total zinc exposure of approximate 13 mg/kg bw/day. The zinc NOAEL derived from the feeding studies with zinc sulphate was determined to be 104 mg Zn/kg bw/day in mice and approximately 53.5 mg/kg bw/day in rats. At higher doses the most important effects in the rats were the development of hypocupremia, and significant changes in the pancreas (i.e., focal acinar degeneration and necrosis) and a decreased number of pigmented macrophages in spleen.No longer term inhalation studies allowing to derive a robust NOEL for the inhalatory exposure of the respective zinc compounds has been identified. In a short term 3-day inhalation study with guinea pigs, a concentration of 2.3 mg ultrafine ZnO/m3 (3 hours/day) resulted in changes in neutrophils and activities of lactate dehydrogenase and alkaline phosphatase in the pulmonary fluid. At higher concentrations increased protein concentration, neutrophils, and enzyme activities in lung lavage fluids were seen, together with significant centriacinar inflammation of the pulmonary tissue. Inhalatory doses of 2.7 mg ultrafine ZnO/m3 for 5 days 3hours/day did not alter the lung function parameters in guinea pigs, but at 5 and 7 mg ultrafine ZnO/m3 exposure according to a similar pattern, a gradual decrease in total lung capacity, vital capacity and reduction of the carbon monoxide diffusing capacity was seen in combination with inflammatory changes and edema. The relevance of the findings in studies with ultra-fine zinc oxide fumes is unclear with respect to commercial grade zinc oxide, as the latter is of much larger particle size and can have different toxicological characteristics. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce29c40f-7126-4915-81e1-ff38bbcdd7bc/documents/8e23a0de-2910-41df-8cf6-3edc66db7bc2_5af1a346-1a8b-4667-921a-be2545a955bd.html,,,,,, Zinc bis(hydroxymethanesulphinate),24887-06-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce29c40f-7126-4915-81e1-ff38bbcdd7bc/documents/8e23a0de-2910-41df-8cf6-3edc66db7bc2_5af1a346-1a8b-4667-921a-be2545a955bd.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,2.7 mg/m3,,guinea pig Zinc bis(hydroxymethanesulphinate),24887-06-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce29c40f-7126-4915-81e1-ff38bbcdd7bc/documents/8e23a0de-2910-41df-8cf6-3edc66db7bc2_5af1a346-1a8b-4667-921a-be2545a955bd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,13.3 mg/kg bw/day,,rat Zinc bis(hydroxymethanesulphinate),24887-06-7," Assessment of the acute oral toxicity of zinc chloride was studied in Sprague-Dawley rats and Swiss mouse according to OECD guideline no 401 .The LD50 value was within the range of 1,100 to 1,260 mg/kg bw. In the 10 min inhalation study in female Sprague-Dawley rats, zinc chloride has demonstrated acute toxicity via the inhalation route (LC50 ≤ 1,975 mg/m3). However, since the exposure of the animals to the size of the particles is not truly representative of exposure to humans under normal conditions, it is difficult to assess whether or not, zinc chloride is acutely toxic since a four hour LC50 value could not be derived and a clear dose-response relationhip coud not be established. Airway irritation has been observed both in animals and in humans, zinc chloride has the potential to be a respiratory tract irritant. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce29c40f-7126-4915-81e1-ff38bbcdd7bc/documents/0e743071-2bd5-4005-aa30-3abdebdc4717_5af1a346-1a8b-4667-921a-be2545a955bd.html,,,,,, Zinc bis(hydroxymethanesulphinate),24887-06-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce29c40f-7126-4915-81e1-ff38bbcdd7bc/documents/0e743071-2bd5-4005-aa30-3abdebdc4717_5af1a346-1a8b-4667-921a-be2545a955bd.html,,oral,LD50,"1,100 mg/kg bw",adverse effect observed, Zinc bis(hydroxymethanesulphinate),24887-06-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce29c40f-7126-4915-81e1-ff38bbcdd7bc/documents/0e743071-2bd5-4005-aa30-3abdebdc4717_5af1a346-1a8b-4667-921a-be2545a955bd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Zinc bis(hydroxymethanesulphinate),24887-06-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce29c40f-7126-4915-81e1-ff38bbcdd7bc/documents/0e743071-2bd5-4005-aa30-3abdebdc4717_5af1a346-1a8b-4667-921a-be2545a955bd.html,,inhalation,LC50,"1,975 mg/m3",adverse effect observed, "Bis(D-gluconato-O1,O2)zinc",4468-02-4," A sub-chronic toxicity was performed on rat and mice study was conducted to evaluate the subchronic toxicity (13 weeks) of the test material in mice and Wistar rats. The study followed was similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents). Mice and rats of both sexes were fed a diet containing the test material at 0, 300, 3,000 and 30,000 ppm for 13 weeks. The clinical signs of the animals, body weight, food, chemical and water intake, food efficiency, haematological, biochemical examination, necropsy and organ weight and histopathological examination were performed.   Rats in the 30,000 ppm group showed retarded growth along with low food intake, abnormal values in a few haematological parameters and regressive changes of the pancreatic exocrine gland. There were no remarkable clinical signs in either sex in groups≤3,000 ppm. Under the test conditions, NOEL of the test material in rats was determined to be 3000 ppm (approximately equivalent to 234 mg/kg/day in male rats and 243 mg/kg/day in female rats).   Mice in the 30,000 ppm group showed retarded growth along with low food intake, abnormal values in a few haematological parameters, decreased water intake and significant deviations in biochemical parameters. Histopathological lesions included catarrh at the upper intestine, ulcers at the boundary of fore- and glandular stomach, proliferation of erythropoietic immature cells in the splenic red pulp as well as pancreatic lesions. Under the test conditions, NOEL of the test material in mice was determined to be 3,000 ppm (approximately equivalent to 458 mg/kg/day in male mice or 479 mg/kg/day in female mice.   This study is considered relevant for read-across purpose. A study conducted on wistar rat where zinc gluconate was administered via intraperitoneal route (Andriollo-Sanchez et al.) confirms the read-across approach used. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65df3dfa-1257-401c-8147-f6552622f253/documents/a50aede6-f0c7-418c-b75d-e144338ca21a_7932d946-8e5e-4c6e-94d8-ca4b80836478.html,,,,,, "Bis(D-gluconato-O1,O2)zinc",4468-02-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65df3dfa-1257-401c-8147-f6552622f253/documents/a50aede6-f0c7-418c-b75d-e144338ca21a_7932d946-8e5e-4c6e-94d8-ca4b80836478.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,234 mg/kg bw/day,,rat "Bis(D-gluconato-O1,O2)zinc",4468-02-4," Acute oral toxicity: The acute oral toxicity of zinc gluconate was investigated in 2 groups of fasted 5 male and 5 female rats of the WISW-strain. Any signs of reaction and mortalities were recorded during the 14-day observation period, animals which died and those killed terminally were subjected to necropsy. In the tested dosage the sample did not induce any clinical-toxicological symptoms. Post-dosing weight gains (2 week values) of all animals did not show essential differences. No mortali ties were observed. Nothing abnormal was found in the animals necropsied on day 14. The determination of the oral LD50 is > 5g/kg. Acute inhalation toxicity: A study was conducted in Sprague-Dawley female rats to determine pulmonary injury after acute inhalation exposure to the zinc chloride. Animals were exposed to the test material at a concentration of 600, 940, 1,220 and 1,950 mg Zn/m3 (molar ratio of Zn: ZnCl2 is 1:2.1) for 10 min. Animals showed respiratory distress. Clinical examination of lung showed discolouration (dark red), varying degrees of congestion, patchy discolouration, oedema and interstitial emphysema, atelectasis, hyperaemia and haemorrhages. Based on the results, the acute inhalation LD50 of the test material was calculated to be approximately 2,000 mg ZnCl2/m3 in rats. This result is used in a read-across approach for Zinc gluconate. The LC50 identified for ZnCl2 have been derived for zinc gluconate, using the following molecular weight : Zinc chloride (ZnCl2) = 136.296 ; Zinc gluconate (ZnC12H22O14) = 455.682. Consequently, the result is given as LD50 = 6686.65 mg of ZnGlc /m3. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65df3dfa-1257-401c-8147-f6552622f253/documents/36d52b9a-c83f-484a-8035-bf5775c5b9f4_7932d946-8e5e-4c6e-94d8-ca4b80836478.html,,,,,, "Bis(D-gluconato-O1,O2)zinc",4468-02-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65df3dfa-1257-401c-8147-f6552622f253/documents/36d52b9a-c83f-484a-8035-bf5775c5b9f4_7932d946-8e5e-4c6e-94d8-ca4b80836478.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Bis(D-gluconato-O1,O2)zinc",4468-02-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65df3dfa-1257-401c-8147-f6552622f253/documents/36d52b9a-c83f-484a-8035-bf5775c5b9f4_7932d946-8e5e-4c6e-94d8-ca4b80836478.html,,inhalation,LC50,"6,686.65 mg/m3",adverse effect observed, "Bis(glycinato-N,O)zinc",14281-83-5,"- In a 2 weeks-dose range finding study for an OECD 422 study, RL1, with the target substance bis(glycinato-N,O)zinc, no effects which could be considered adverse were observed at all dose levels investigated (100, 300 and 1000 mg/kg/day). - In a 2-weeks dose range finding study, RL1, no effects which could be considered adverse were observed in animals receiving zinc monoglycinate sulfate hydrate for 2 weeks at all dose levels investigated (100, 300 and 1000 mg/kg/day). - the NOAEL of zinc threoninate was 675 mg/kg bw/day in male and female SD rats in the course of a thirty-day repeated dose toxicity diet study (Hu et al., 2010. RL2). Recalculated for the target substance, this refers to a NOAEL of bis(glycinato-N,O)zinc of 426.9 mg/kg bw/day in male and female SD rats. As a worst-case approach, the most conservative value (NOAEL 426.9 mg/kg bw/day) has been chosen for assessment. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/053fc5b7-0b06-49b4-af20-93f002554991/documents/4d944c2c-d99f-4f96-adbb-a4adc0381046_b83e0ec8-2f2d-429c-8021-aee03047409f.html,,,,,, "Bis(glycinato-N,O)zinc",14281-83-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/053fc5b7-0b06-49b4-af20-93f002554991/documents/4d944c2c-d99f-4f96-adbb-a4adc0381046_b83e0ec8-2f2d-429c-8021-aee03047409f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,426.9 mg/kg bw/day,,rat "Bis(glycinato-N,O)zinc",14281-83-5,"The study was conducted according to OECD guideline 425 under GLP conditions, thus, there are no limitations of the quality of the database. The LD50 value for the test item is <= 2000 mg/kg following single-dose intragastric administration to male and female rats.  ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/053fc5b7-0b06-49b4-af20-93f002554991/documents/bd740ea0-7d0c-4ab9-a74b-a6581ef3b46f_b83e0ec8-2f2d-429c-8021-aee03047409f.html,,,,,, "Bis(glycinato-N,O)zinc",14281-83-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/053fc5b7-0b06-49b4-af20-93f002554991/documents/bd740ea0-7d0c-4ab9-a74b-a6581ef3b46f_b83e0ec8-2f2d-429c-8021-aee03047409f.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Zinc hydroxide,20427-58-1,"Animal data Oral: The repeated dose toxicity of the zinc category substances has been examined in a number of sub-chronic oral repeated dose toxictiy studies. The NOAEL for systemic effects of the zinc category substances was determined to be 25 mg Zn/kg bw/day, derived in an oral 90-day study with nano zinc oxide in rats. Inhalation: The repeated dose inhalation toxicity of micro and nano-ZnO has been examined respectively in a subacute (28 days) and two subchronic (90 days) inhalation studies. The lowest NOAEC was determined to be 0.47 mg/m³ (target concentration: 0.5 mg/m³) for micro ZnO. For nano-ZnO the BMCL10 was determined to be 0.971 mg/m³. Dermal: No adverse effects were observed in a 90-day repeated dose toxicity study via the dermal route with nano-ZnO. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/318c14d1-54ba-4d82-96c1-47d04feb2ecb/documents/d3dbfe8d-29df-4047-bae7-35d291fdb315_ed18f98f-ad06-4b37-8840-820f63dcb0d8.html,,,,,, Zinc hydroxide,20427-58-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/318c14d1-54ba-4d82-96c1-47d04feb2ecb/documents/d3dbfe8d-29df-4047-bae7-35d291fdb315_ed18f98f-ad06-4b37-8840-820f63dcb0d8.html,Repeated dose toxicity – local effects,inhalation,BMCL10,0.971 mg/m3,adverse effect observed,rat Zinc hydroxide,20427-58-1,Acute oral toxicity: key study carried out according to OECD guideline no 423 indicating for zinc hydroxide LD50 > 2000 mg/kg bw Acute inhalation toxicity: key study carried out according to OECD guideline no 403 indicating for zinc oxide LC50 > 5.7 mg/L/4hrs (read-across to zinc hydroxide) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/318c14d1-54ba-4d82-96c1-47d04feb2ecb/documents/IUC5-02b89a5b-3637-4b8a-8e39-c8dd90cb5a93_ed18f98f-ad06-4b37-8840-820f63dcb0d8.html,,,,,, Zinc hydroxide,20427-58-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/318c14d1-54ba-4d82-96c1-47d04feb2ecb/documents/IUC5-02b89a5b-3637-4b8a-8e39-c8dd90cb5a93_ed18f98f-ad06-4b37-8840-820f63dcb0d8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Zinc hydroxide,20427-58-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/318c14d1-54ba-4d82-96c1-47d04feb2ecb/documents/IUC5-02b89a5b-3637-4b8a-8e39-c8dd90cb5a93_ed18f98f-ad06-4b37-8840-820f63dcb0d8.html,,inhalation,LC50,"5,700 mg/m3",no adverse effect observed, Zinc dilactate,16039-53-5, Information is available for the oral and dermal route. The systemic toxicity of zinc lactate via any route can be understood in terms of systemic toxicity of lactic acid and zinc(II). The available information is sufficient for route-to-route extrapolation. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c126866-3686-47c4-9afb-6bd8a721b2af/documents/IUC5-56f9290c-9211-4e8a-92cd-5919f0f51c21_d1d72414-8a8a-451a-9e29-bfd4417038c0.html,,,,,, Zinc dilactate,16039-53-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c126866-3686-47c4-9afb-6bd8a721b2af/documents/IUC5-56f9290c-9211-4e8a-92cd-5919f0f51c21_d1d72414-8a8a-451a-9e29-bfd4417038c0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,234 mg/kg bw/day,,rat Zinc dilactate,16039-53-5, In an oral toxicity study with zinc lactate the LD50 was estimated to be 1190 mg/kg bw. In studies performed with soluble zinc salts as suitable read-across substances no adverse effects were observed that would warrant classification for acute dermal and inhalation toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c126866-3686-47c4-9afb-6bd8a721b2af/documents/IUC5-9a3457fa-4d39-459e-a4c6-a1e7470fb7c1_d1d72414-8a8a-451a-9e29-bfd4417038c0.html,,,,,, Zinc dilactate,16039-53-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c126866-3686-47c4-9afb-6bd8a721b2af/documents/IUC5-9a3457fa-4d39-459e-a4c6-a1e7470fb7c1_d1d72414-8a8a-451a-9e29-bfd4417038c0.html,,oral,LD50,"1,190 mg/kg bw",adverse effect observed, Zinc dilactate,16039-53-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c126866-3686-47c4-9afb-6bd8a721b2af/documents/IUC5-9a3457fa-4d39-459e-a4c6-a1e7470fb7c1_d1d72414-8a8a-451a-9e29-bfd4417038c0.html,,inhalation,LC50,"3,551 mg/m3",adverse effect observed, Zinc dilaurate,2452-01-9,"The oral NOAEL of 0.83 mg Zn/kg bw/day (recalculated from the NOAEL of 50 mg Zn/day for a 60 kg human being), derived from a 10 week oral human volunteer study on zinc gluconate will be used as the starting point for deriving DNELs for worker and general population. NOAELs for zinc exposure via the dermal or inhalatory route can be estimated by taking into account the bioavailability of zinc via the different exposure routes (for details see section 5.1 of Appendix 1 of the CSR). By zinc content correction, these data are read-across to zinc dilaurate. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b291f681-a727-41f2-a3b1-ad1f22b1a624/documents/IUC5-ce85c875-5f48-4dc3-b77c-8efa84d79c9a_dc2406fa-a613-4efd-a780-0c6892e4003d.html,,,,,, Zinc dilaurate,2452-01-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b291f681-a727-41f2-a3b1-ad1f22b1a624/documents/IUC5-ce85c875-5f48-4dc3-b77c-8efa84d79c9a_dc2406fa-a613-4efd-a780-0c6892e4003d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5.93 mg/kg bw/day,,"other:human data, NOEAL is derived from dietary supplement studies on zinc gluconate and recalculated for zinc dilaurate based on zinc content" Zinc dilaurate,2452-01-9,"The slightly soluble and insoluble zinc compounds (i.e., zinc oxide, zinc hydroxide, zinc phosphate, zinc carbonate, zinc metal and zinc sulphide as well as zinc dilaurate) are of low acute, dermal and inhalation toxicity not requiring a classification for acute toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b291f681-a727-41f2-a3b1-ad1f22b1a624/documents/IUC5-f0b59e0a-cbe9-4362-8867-1ca57b23881c_dc2406fa-a613-4efd-a780-0c6892e4003d.html,,,,,, Zinc dilaurate,2452-01-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b291f681-a727-41f2-a3b1-ad1f22b1a624/documents/IUC5-f0b59e0a-cbe9-4362-8867-1ca57b23881c_dc2406fa-a613-4efd-a780-0c6892e4003d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Zinc dilaurate,2452-01-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b291f681-a727-41f2-a3b1-ad1f22b1a624/documents/IUC5-f0b59e0a-cbe9-4362-8867-1ca57b23881c_dc2406fa-a613-4efd-a780-0c6892e4003d.html,,inhalation,discriminating conc.,5.08 mg/m3,no adverse effect observed, Zinc dimyristate,16260-27-8," No repeated dose toxicity study with zinc ditetradecanoate is available, thus the repeated dose toxicity will be addressed with existing data on the entities formed upon dissolution of zinc ditetradecanoate, namely zinc and tetradecanoate.Since the naturally occurring fatty acid tetradecanoic acid (aka Myristic acid) is void of any human health hazard potential, the hazard assessment will be derived based on the toxicological information for zinc and the human life-time NOAEL of 0.83 mg/kg bw/day will be used further. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/039e78f5-3f0b-43fc-89cf-5cfa340bf08d/documents/7c40bea5-e7d8-4901-a01a-9206c51ce37f_17c07249-5d0f-4c2e-a2d7-328644244d10.html,,,,,, Zinc dimyristate,16260-27-8," No acute toxicity studies with zinc ditetradecanoate are available, thus the acute toxicity will be addressed with existing data on the dissociation products zinc and tetradecanoic acid. Signs of acute oral or acute dermal toxicity are not expected for zinc ditetradecanoate, since for the moiety zinc, has not shown signs of acute oral toxicity (LD50 > 2000mg/kg) and acute dermal toxicity is considered to be low in view of the poor absorption by this route. The moiety tetradecanoate has not shown signs of acute oral or acute dermal toxicity in experimental testing (LD50 > 2000mg/kg). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/039e78f5-3f0b-43fc-89cf-5cfa340bf08d/documents/c632a8c4-89b2-475f-8abc-fd990febcc7b_17c07249-5d0f-4c2e-a2d7-328644244d10.html,,,,,, Zinc neodecanoate,27253-29-8,Low toxicity. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5aa8ca9-3c0e-4bbf-a2e2-be7b1f787760/documents/IUC5-561f99e0-28b2-425e-ac64-749f70c8ed57_2b5c6a68-d8f0-4c27-9a31-56200d610a06.html,,,,,, Zinc neodecanoate,27253-29-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5aa8ca9-3c0e-4bbf-a2e2-be7b1f787760/documents/IUC5-561f99e0-28b2-425e-ac64-749f70c8ed57_2b5c6a68-d8f0-4c27-9a31-56200d610a06.html,,oral,LD50,"2,064 mg/kg bw",, Zinc neodecanoate,27253-29-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5aa8ca9-3c0e-4bbf-a2e2-be7b1f787760/documents/IUC5-561f99e0-28b2-425e-ac64-749f70c8ed57_2b5c6a68-d8f0-4c27-9a31-56200d610a06.html,,dermal,LD50,"3,640 mg/kg bw",, Zinc neodecanoate,27253-29-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5aa8ca9-3c0e-4bbf-a2e2-be7b1f787760/documents/IUC5-561f99e0-28b2-425e-ac64-749f70c8ed57_2b5c6a68-d8f0-4c27-9a31-56200d610a06.html,,inhalation,LC50,"3,000 mg/m3",, Zinc nitrate,7779-88-6,"Animal data   Oral: The repeated dose toxicity of the zinc category substances has been examined in a number of sub-chronic oral repeated dose toxictiy studies. The NOAEL for systemic effects of the zinc category substances was determined to be 25 mg Zn/kg bw/day, derived in an oral 90-day study with nano zinc oxide in rats. Inhalation: The repeated dose inhalation toxicity of micro and nano-ZnO has been examined respectively in a subacute (28 days) and subchronic (90 days) inhalation study. The lowest NOAEC was determined to be 0.47 mg/m³ (target concentration: 0.5 mg/m³) for micro ZnO. For nano-ZnO the NOAEC was determined to be 1.48 mg/m³ (target concentration 1.5 mg/m³). Dermal: No adverse effects were observed in a 90-day repeated dose toxicity study via the dermal route with nano-ZnO. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): guideline studies available ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d18da6bc-cdf9-4362-a050-2038b65bde76/documents/d3dbfe8d-29df-4047-bae7-35d291fdb315_6d177d19-a5ea-46e5-b0c3-3dc044ef7731.html,,,,,, Zinc nitrate,7779-88-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d18da6bc-cdf9-4362-a050-2038b65bde76/documents/d3dbfe8d-29df-4047-bae7-35d291fdb315_6d177d19-a5ea-46e5-b0c3-3dc044ef7731.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1.48 mg/m3,adverse effect observed,rat Zinc nitrate,7779-88-6,"Assessment of the acute oral toxicity of zinc nitrate was studied in Wistar CRL/WI rats according to OECD guideline no 423 (Acute toxic Class Method) .The LD50 value was established to be greater than 300 mg/kg bw but less than 2000 mg/kg bw. There are no specific data for zinc nitrate available on which to evaluate for acute inhalation and dermal toxicity. Read-across towards soluble zinc chloride and zinc sulphate, indicates that zinc nitrate is of very low acute inhalation and dermal toxicity not requiring a classification according to the EC criteria. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d18da6bc-cdf9-4362-a050-2038b65bde76/documents/IUC5-69a9c46c-515d-4253-8895-fbe378299791_6d177d19-a5ea-46e5-b0c3-3dc044ef7731.html,,,,,, Zinc nitrate,7779-88-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d18da6bc-cdf9-4362-a050-2038b65bde76/documents/IUC5-69a9c46c-515d-4253-8895-fbe378299791_6d177d19-a5ea-46e5-b0c3-3dc044ef7731.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Zinc nitrate,7779-88-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d18da6bc-cdf9-4362-a050-2038b65bde76/documents/IUC5-69a9c46c-515d-4253-8895-fbe378299791_6d177d19-a5ea-46e5-b0c3-3dc044ef7731.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Bis(5-oxo-L-prolinato-N1,O2)zinc",15454-75-8," The repeat dose oral toxicity of the test material was evaluated using a read-across approach. Suitable analogues were found in the OECD QSAR Toolbox using the Organic Functional Group category, and the results were refined using relevant subcategories. Based on the modelled conditions, the subacute NOEL of the test material in the rat was determined to be ca. 7.8 mg/kg bw/day. The target chemical falls within the applicability domain of the prediction. However, according to an EFSA opinion (please refer to Section 13 for more information), ZN-100, also known as zinc L-pidolate, is used as a food supplement. Once in the body ZN-100 will dissociate into its components i.e. L-pidolic acid and zinc. According to EFSA a daily intake of L-pidolic acid of 3 g/day in humans is of no safety concern. This value corresponds to 50 mg/kg bw/day of L-pidolic acid or 62 mg/kg bw/day of zinc L-pidolate (ZN-100).  Nevertheless, based on the Scientific Committee on Food (please refer to Section 13 for more information), a clear NOAEL for zinc is established at 50 mg/day for humans, which corresponds to a human NOAEL of 4 mg/kg bw/day for ZN-100. Therefore, the human NOAEL of 4 mg/kg bw/day was considered to be the most appropriate and conservative value to be used for the DNEL derivation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e976dba-fc42-45da-9ed2-6f2132139241/documents/eba052b8-b2f5-4a86-9185-43bf40d165f6_590d5ba1-1240-4823-bea8-5d1fb337ff0f.html,,,,,, "Bis(5-oxo-L-prolinato-N1,O2)zinc",15454-75-8," Oral Under the conditions of this study, it was estimated that the LD50 value of the test material is greater than 2.0 g/kg body weight when dosed to male and female SD rats. Dermal Under the conditions of this study, the acute dermal LD50 value of the test material was found to be above 2 000 mg/kg bw in male and female CRL:(WI) rats. Inhalation According to Column 2 of REACH Annex VIII, in addition to the oral route, for substances other than gases, information shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure.  Exposure via the dermal route is more likely than via the inhalation route and data has therefore been provided for exposure via the dermal route.  Information on exposure via the inhalation route is not required. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e976dba-fc42-45da-9ed2-6f2132139241/documents/IUC5-f192493d-d349-401f-95b3-2758887c2933_590d5ba1-1240-4823-bea8-5d1fb337ff0f.html,,,,,, "Bis(5-oxo-L-prolinato-N1,O2)zinc",15454-75-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e976dba-fc42-45da-9ed2-6f2132139241/documents/IUC5-f192493d-d349-401f-95b3-2758887c2933_590d5ba1-1240-4823-bea8-5d1fb337ff0f.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "Bis(5-oxo-L-prolinato-N1,O2)zinc",15454-75-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e976dba-fc42-45da-9ed2-6f2132139241/documents/IUC5-f192493d-d349-401f-95b3-2758887c2933_590d5ba1-1240-4823-bea8-5d1fb337ff0f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Zinc diricinoleate,13040-19-2,"Non-human informationThe repeated dose toxicity of water soluble zinc sulphate and zinc monoglycerolate has been examined in a total of 3 subchronic oral feeding studies. Due to the different dosing regimens, the lowest NOAEL was determined to be 31.5 mg/kg bw/day of zinc monoglycerolate which equals a total zinc exposure of approximate 13 mg/kg bw/day. The zinc NOAEL derived from the feeding studies with zinc sulphate was determined to be 104 mg Zn/kg bw/day in mice and approximately 53.5 mg/kg bw/day in rats. At higher doses the most important effects in the rats were the development of hypocupremia, and significant changes in the pancreas (i.e., focal acinar degeneration and necrosis) and a decreased number of pigmented macrophages in spleen.No longer term inhalation studies allowing to derive a robust NOEL for the inhalatory exposure of the respective zinc compounds has been identified. In a short term 3-day inhalation study with guinea pigs, a concentration of 2.3 mg ultrafine ZnO/m3 (3 hours/day) resulted in changes in neutrophils and activities of lactate dehydrogenase and alkaline phosphatase in the pulmonary fluid. At higher concentrations increased protein concentration, neutrophils, and enzyme activities in lung lavage fluids were seen, together with significant centriacinar inflammation of the pulmonary tissue. Inhalatory doses of 2.7 mg ultrafine ZnO/m3 for 5 days 3hours/day did not alter the lung function parameters in guinea pigs, but at 5 and 7 mg ultrafine ZnO/m3 exposure according to a similar pattern, a gradual decrease in total lung capacity, vital capacity and reduction of the carbon monoxide diffusing capacity was seen in combination with inflammatory changes and edema. The relevance of the findings in studies with ultra-fine zinc oxide fumes is unclear with respect to commercial grade zinc oxide, as the latter is of much larger particle size and can have different toxicological characteristics. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91285d57-f8ca-4300-8c94-68bf507c6f36/documents/IUC5-e6a2af1a-2371-40ca-a573-0b07f96f9180_7fb6c256-3c2e-4a10-a81f-57fa9c11c8b5.html,,,,,, Zinc diricinoleate,13040-19-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91285d57-f8ca-4300-8c94-68bf507c6f36/documents/IUC5-e6a2af1a-2371-40ca-a573-0b07f96f9180_7fb6c256-3c2e-4a10-a81f-57fa9c11c8b5.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,2.7 mg/m3,,guinea pig Zinc diricinoleate,13040-19-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91285d57-f8ca-4300-8c94-68bf507c6f36/documents/IUC5-e6a2af1a-2371-40ca-a573-0b07f96f9180_7fb6c256-3c2e-4a10-a81f-57fa9c11c8b5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,13.3 mg/kg bw/day,,rat Dizinc orthosilicate,13597-65-4, Acute oral and acute inhalation toxicity data are read across from zinc and soluble zinc compounds. Acute oral toxicity: key studies carried out according to OECD guideline no 401 or 423 indicating for both micro- and nanomaterial zinc oxide LD50 > 2000 mg/kg bw Acute inhalation toxicity: key study carried out according to OECD guideline no 403 indicating for micro zinc oxide LC50 > 5.7 mg/L/4hrs. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f796b0b8-4169-4de2-b417-ed6052a20ea7/documents/9acc79a3-c4ad-4344-83c5-33a83d0b6997_871d21e5-2fbd-46b5-8203-3e7c545a40fd.html,,,,,, Dizinc orthosilicate,13597-65-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f796b0b8-4169-4de2-b417-ed6052a20ea7/documents/9acc79a3-c4ad-4344-83c5-33a83d0b6997_871d21e5-2fbd-46b5-8203-3e7c545a40fd.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Dizinc orthosilicate,13597-65-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f796b0b8-4169-4de2-b417-ed6052a20ea7/documents/9acc79a3-c4ad-4344-83c5-33a83d0b6997_871d21e5-2fbd-46b5-8203-3e7c545a40fd.html,,inhalation,LC50,"5,700 mg/m3",no adverse effect observed, Zinc distearate,557-05-1," Repeated dose toxicity: Oral The No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg/bw/ day in male and female Sprague Dawley rats when exposed to test chemical Zinc Distearate (ZDS) (557-05-1) for 28 days by oral gavage. . Repeated dose toxicity: Inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance Zinc Distearate (ZDS) (557-05-1) which is reported as 0.02707723 mmHg at 25 C. Also considering the particle size distribution of the substance the majority of the particles was found to be in the size of 500 micron to 150 micron which is much larger size range compared to the inhalable particulate matter .Thus, exposure to inhalable dust, mist and vapour of the chemical Zinc Distearate is highly unlikely. Therefore this study is considered for waiver. Repeated dose toxicty: Dermal The acute toxicity value for Zinc Distearate (ZDS) (557-05-1) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected Zinc Distearate shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Zinc Distearate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6428d6a0-92d8-48fe-baaa-73c0126e13a6/documents/ddc5f65e-7ddb-4a70-8052-86fc4441d441_20e1d4e7-c57f-4db7-bb18-abb19467e862.html,,,,,, Zinc distearate,557-05-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6428d6a0-92d8-48fe-baaa-73c0126e13a6/documents/ddc5f65e-7ddb-4a70-8052-86fc4441d441_20e1d4e7-c57f-4db7-bb18-abb19467e862.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Zinc distearate,557-05-1," Acute oral toxicity:  Acute oral toxicity dose (LD50) for target chemical test chemical was considered based on experimental study conducted on rats. The LD50 value was considered to be >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute oral toxicity. Acute Inhalation toxicity: The acute Inhalation toxicity dose (LC50) for test chemical was considered based on experimental study conducted on rats. The LC50 value was considered to be >200 mg/L (>200000 mg/m3). The study concluded that the LC50 value is >5 mg/L, for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute inhalation toxicity. Acute Dermal toxicity: The acute dermal toxicity dose (LD50) for target chemical was considered based on experimental study conducted on rabbits, the value was considered to be >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute dermal toxicity. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6428d6a0-92d8-48fe-baaa-73c0126e13a6/documents/67b0e877-9c3d-4c17-b619-7908243f513e_20e1d4e7-c57f-4db7-bb18-abb19467e862.html,,,,,, Zinc distearate,557-05-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6428d6a0-92d8-48fe-baaa-73c0126e13a6/documents/67b0e877-9c3d-4c17-b619-7908243f513e_20e1d4e7-c57f-4db7-bb18-abb19467e862.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Zinc distearate,557-05-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6428d6a0-92d8-48fe-baaa-73c0126e13a6/documents/67b0e877-9c3d-4c17-b619-7908243f513e_20e1d4e7-c57f-4db7-bb18-abb19467e862.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Zinc distearate,557-05-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6428d6a0-92d8-48fe-baaa-73c0126e13a6/documents/67b0e877-9c3d-4c17-b619-7908243f513e_20e1d4e7-c57f-4db7-bb18-abb19467e862.html,,inhalation,LC50,"200,000 mg/m3",no adverse effect observed, Zinc sulphate,7733-02-0,"Animal data Oral: The repeated dose toxicity of the zinc category substances has been examined in a number of sub-chronic oral repeated dose toxictiy studies. The NOAEL for systemic effects of the zinc category substances was determined to be 25 mg Zn/kg bw/day, derived in an oral 90-day study with nano zinc oxide in rats. Inhalation: The repeated dose inhalation toxicity of micro and nano-ZnO has been examined respectively in a subacute (28 days) and two subchronic (90 days) inhalation studies. The lowest NOAEC was determined to be 0.47 mg/m³ (target concentration: 0.5 mg/m³) for micro ZnO. For nano-ZnO the BMCL10 was determined to be 0.971 mg/m³. Dermal: No adverse effects were observed in a 90-day repeated dose toxicity study via the dermal route with nano-ZnO. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): guideline studies available ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f52f0587-7fc5-48ac-9871-fad81da052f7/documents/d3dbfe8d-29df-4047-bae7-35d291fdb315_eb83b585-604a-4c2c-b32a-4de0a8b0470c.html,,,,,, Zinc sulphate,7733-02-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f52f0587-7fc5-48ac-9871-fad81da052f7/documents/d3dbfe8d-29df-4047-bae7-35d291fdb315_eb83b585-604a-4c2c-b32a-4de0a8b0470c.html,Repeated dose toxicity – local effects,inhalation,BMCL10,0.971 mg/m3,adverse effect observed,rat Zinc sulphate,7733-02-0," Assessment of the acute oral toxicity of zinc sulphate was studied in Sprague-Dawley or Wistar rats and Swiss mouse according to OECD guideline no 401 or 423. Soluble zinc sulphate (monohydrate, hexahydrate and heptahydrate) has LD50 oral values ranging from 574 to 2,949 mg/kg bw, 862 to 4,429 mg/kg bw and 920 to 4,725 mg/kg bw, respectively for the three forms of zinc sulphate. Effects of inhalation exposure to zinc sulphate were limited to pulmonary effects only. Assessment of acute dermal toxicity was studied on the skin of Wistar rats at 2000 mg/kg bw for 24 hours (OECD guideline no 402) demonstrating zinc sulphate is not acutely toxic via the dermal route (LD50 >2,000 mg/kg bw) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f52f0587-7fc5-48ac-9871-fad81da052f7/documents/IUC5-155a07c1-2830-422e-b1ce-6e32eefa8e5a_eb83b585-604a-4c2c-b32a-4de0a8b0470c.html,,,,,, Zinc sulphate,7733-02-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f52f0587-7fc5-48ac-9871-fad81da052f7/documents/IUC5-155a07c1-2830-422e-b1ce-6e32eefa8e5a_eb83b585-604a-4c2c-b32a-4de0a8b0470c.html,,oral,LD50,574 mg/kg bw,adverse effect observed, Zinc sulphate,7733-02-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f52f0587-7fc5-48ac-9871-fad81da052f7/documents/IUC5-155a07c1-2830-422e-b1ce-6e32eefa8e5a_eb83b585-604a-4c2c-b32a-4de0a8b0470c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Zinc sulphide,1314-98-3,"Oral: The repeated dose toxicity of zinc sulfide has been examined in a sub-chronic oral repeated dose toxictiy study in Wistar rats. There were no treatment related deaths, no relevant treatment related clinical findings and no changes to food intake and body weight development. The NOAEL for systemic effects of zinc sulfide is above the limits dose of 1000 mg/kg bw/day. Inhalation: The substance zinc sulfide is an inorganic zinc substance with very poor water solubility and in vitro bioaccessibility in various biological media. In addition, the substance shows a pronounced tendency to form aggregates once becoming airborne, which leads to a low tendency for deposition in the deeper lung. Further toxicological data shows a complete lack of local effects towards (mucous) membranes, hence a very low hazard potential of the inhalable particles is assumed. Consequently, inhalation is not considered a relevant route of human exposure for zinc sulfide. Dermal: According to Annex VIII and IX, column 2, the repeated dose toxicity test (dermal route) does not need to be conducted, since the available physicochemical properties and toxicological properties suggest a low potential for dermal absorption. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1cfce20d-b18c-4003-92d7-5bd37f7ac26f/documents/1ac26a93-af27-4e7b-8e9f-263121ff5214_1d590a3e-7404-4162-acb9-1c37b0b67a32.html,,,,,, Zinc sulphide,1314-98-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1cfce20d-b18c-4003-92d7-5bd37f7ac26f/documents/1ac26a93-af27-4e7b-8e9f-263121ff5214_1d590a3e-7404-4162-acb9-1c37b0b67a32.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Zinc sulphide,1314-98-3,"In the study performed by RCC Ltd (2003), rats were treated with ZnS-Sachtolith HD-S by oral gavage administration at a dosage of 2000 mg/kg body weight. All animals survived until the end of the study period. No clinical signs were observed during the course of the study. The median lethal dose of ZnS-Sachtolith HD-S after single oral administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat): greater than 2000 mg/kg body weight. In the acute nose-only inhalation study performed by Bruer et al (2023), the maximum achievable concentration of ZnS aerosols (0,85mg/L) was tested in 3 male and 3 female rats. There were no deaths and no treatment related adverse effects observed during the 4h exposure of during the 14day observation period. The LC0 is therefore 0,82mg/L and the LC50 value is considered higher than 820.44 mg/m3, which is the maximum technically achievable aerosol concentration Regarding acute dermal toxicity, no data are available on which to evaluate toxicity for slightly soluble or insoluble zinc compounds. However, acute dermal toxicity can be considered to be low in view of the poor absorption by this route.  ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1cfce20d-b18c-4003-92d7-5bd37f7ac26f/documents/52d13416-8e65-4c2c-8f7f-4a5d491a4963_1d590a3e-7404-4162-acb9-1c37b0b67a32.html,,,,,, Zinc sulphide,1314-98-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1cfce20d-b18c-4003-92d7-5bd37f7ac26f/documents/52d13416-8e65-4c2c-8f7f-4a5d491a4963_1d590a3e-7404-4162-acb9-1c37b0b67a32.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Zinc sulphide,1314-98-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1cfce20d-b18c-4003-92d7-5bd37f7ac26f/documents/52d13416-8e65-4c2c-8f7f-4a5d491a4963_1d590a3e-7404-4162-acb9-1c37b0b67a32.html,,inhalation,LC50,> 0.82 mg/L,no adverse effect observed, Zirconium bis(hydrogen phosphate),13772-29-7,The LD50 of the test substance was greater than 2000 mg/kg bw in an acute oral toxicity study in rats. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f590ca7-8b99-4d24-a726-d8b6c642a91a/documents/IUC5-fed361be-83c9-4d1a-9d6a-7d32ac0d039c_47f0d349-9782-4a12-a904-792c4a6e6500.html,,,,,, Zirconium bis(hydrogen phosphate),13772-29-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f590ca7-8b99-4d24-a726-d8b6c642a91a/documents/IUC5-fed361be-83c9-4d1a-9d6a-7d32ac0d039c_47f0d349-9782-4a12-a904-792c4a6e6500.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Zirconium,7440-67-7,"As Zr powder is pyrophoric, it is technically not possible to generate an inhalable test atmosphere even for long term studies. The evaluation of repeated dose toxicity inhalation of Zr may not be technically possible.Based on the same behaviour and toxicological effects, a read across with ZrO2 is performed. No effect was observed following repeated inhalation of ZrO2. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00a0e87b-451f-4011-aaac-f0b60f0a9ed3/documents/IUC5-98971f15-5c44-41f8-a331-b4cc87313ecf_1b52ad2e-c36b-43f0-b157-0079d14d4b68.html,,,,,, Zirconium,7440-67-7,"One study is available for acute toxicity via the oral route of exposure (according to OECD 423): the LD50 is > 2000 mg/kg (rat) and the LD50cut off is > 5000 mg/kg.No reliable data is available for acute toxicity via the inhalation route of exposure. As Zr powder is pyrophoric, it is not technically possible to generate an inhalable test atmosphere. Based on the same behaviour and toxicological effects, a read across with ZrO2 is performed. No toxic effect is observed in the available study, the LC50 is therefore > 4.3 mgZrO2/L or >3.18 mg eq Zr/L ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00a0e87b-451f-4011-aaac-f0b60f0a9ed3/documents/IUC5-02b0b384-26b2-415e-afc7-45f7810940df_1b52ad2e-c36b-43f0-b157-0079d14d4b68.html,,,,,, Zirconium dichloride oxide,7699-43-6," Repeated dose toxicity - oral route:Rossiello (2013) performed a combined repeated dose toxicity study (scored Klimisch 1) with reproduction/developmental toxicity screening test via oral route in rats according to OECD guideline 422. This study was performed in compliance with GLP guidelines. A NOAEL of >=1000 mg/kg bw/day was derived (expressed as zirconium acetate anhydrous). No adverse effects were reported in this study. Zirconium acetate is a water-soluble zirconium compound with similar behaviour as zirconium dinitrate oxide. Therefore the results of this study are considered relevant for zirconium dinitrate oxide too.Repeated dose toxicity: inhalation:Inhalation of 11.3 mg/m3 zirconium dichloride oxide for 60 days produced no significant changes in mortality rate, growth, biochemistry, hematology values and histopathology in various animal species. The NOAEC is therefore considered to be >= 11.3 mg/m3. Repeated dose toxicity: dermal:No reliable data are available for repeated dose toxicity via the dermal route of exposure. Since key studies are available for two routes of exposure (oral and inhalation exposure), no testing is required via the dermal route. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e16f812b-aebd-4db0-92c1-abb4629f8fb6/documents/IUC5-1b8714ef-77cd-4ba4-8994-f7010d7bf546_32a4e498-c76a-4251-9a6f-0d19ddc9dd78.html,,,,,, Zirconium dichloride oxide,7699-43-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e16f812b-aebd-4db0-92c1-abb4629f8fb6/documents/IUC5-1b8714ef-77cd-4ba4-8994-f7010d7bf546_32a4e498-c76a-4251-9a6f-0d19ddc9dd78.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Zirconium dichloride oxide,7699-43-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e16f812b-aebd-4db0-92c1-abb4629f8fb6/documents/IUC5-1b8714ef-77cd-4ba4-8994-f7010d7bf546_32a4e498-c76a-4251-9a6f-0d19ddc9dd78.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,11.3 mg/m3,,other:various species Zirconium dichloride oxide,7699-43-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e16f812b-aebd-4db0-92c1-abb4629f8fb6/documents/IUC5-1b8714ef-77cd-4ba4-8994-f7010d7bf546_32a4e498-c76a-4251-9a6f-0d19ddc9dd78.html,Repeated dose toxicity – local effects,inhalation,NOAEC,11.3 mg/m3,no adverse effect observed,other:various species Zirconium dichloride oxide,7699-43-6,"Acute toxicity: oralOne reliable study was available which determined a LD50 of 3500 mg/kg bw in rats (Cochran et al., 1950).Acute toxicity: inhalationNo study required. In addition the substance is corrosive.Acute toxicity: dermalNo study needs to be conducted as the substance is skin corrosive.Acute toxicity: other routesOne reliable study was available for the intraperitoneal route of exposure and determined a LD50 of 400 mg/kg bw (Cochran et al., 1950). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e16f812b-aebd-4db0-92c1-abb4629f8fb6/documents/IUC5-2316eccf-9a78-416f-bf28-c87bd106d55a_32a4e498-c76a-4251-9a6f-0d19ddc9dd78.html,,,,,, Zirconium dichloride oxide,7699-43-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e16f812b-aebd-4db0-92c1-abb4629f8fb6/documents/IUC5-2316eccf-9a78-416f-bf28-c87bd106d55a_32a4e498-c76a-4251-9a6f-0d19ddc9dd78.html,,oral,LD50,"3,500 mg/kg bw",no adverse effect observed, "Tar acids, coal, crude",65996-85-2,"In humans and experimental animals the signs and symptoms of acute toxicity are similar regardless of the route of administration (compare also with data presented in the Summary of Section 7.1). Beside the concentration dependent local effects (corrosive properties of phenol) also systemic effects are obvious. Muscle weakness, convulsions, and coma are the predominant symptoms associated with exposure to lethal concentrations of phenol. Regardless of the route of exposure, absorption is rapid, as illustrated by the fact that acute doses of phenol can produce symptoms of toxicity within minutes after administration. For animals, dermal and oral LD50 values are reported in the literature falling within one order of magnitude: oral LD50 in rats 340 -650 mg/kg bw and dermal LD50 in rats 660 (525 -707) mg/kg bw and in rabbits 850 mg/kg bw. Although LC50 values are not available in literature, rats are reported to have tolerated phenol concentrations as high as 236 ppm (900 mg/m³) for 8 hours, resulting in ocular and nasal irritation, loss of coordination. The odour recognition threshold (100% response) of phenol in humans is approximately 0.05 ppm, a concentration far below the levels where toxic effects have been reported; thus, the chemical has good warning properties for inhalation exposure. Oral toxicity of phenol in humans leading to the death of the victim is reported for doses as low as 140-290 mg/kg body weight. Absorption from spilling phenolic solutions on the skin of humans may be very rapid, and death results from collapse within 30 minutes to several hours. Death has resulted from absorption of phenol through a skin area of 64 inch². Based on these data phenol has been classified as “toxic” and labelled with “R 23/24/25 (Toxic by inhalation, in contact with skin and if swallowed)”. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7663ecab-47df-4333-9692-c80afbebf91d/documents/IUC5-9a097516-2e6a-4b1b-9ef7-784a41db6d85_ce155e3c-0163-4dc3-a780-c184fdff297a.html,,,,,, "Tar acids, coal, crude",65996-85-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7663ecab-47df-4333-9692-c80afbebf91d/documents/IUC5-9a097516-2e6a-4b1b-9ef7-784a41db6d85_ce155e3c-0163-4dc3-a780-c184fdff297a.html,,oral,LD50,340 mg/kg bw,, "Tar acids, coal, crude",65996-85-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7663ecab-47df-4333-9692-c80afbebf91d/documents/IUC5-9a097516-2e6a-4b1b-9ef7-784a41db6d85_ce155e3c-0163-4dc3-a780-c184fdff297a.html,,dermal,LD50,660 mg/kg bw,, "Naphtha (petroleum), full-range straight-run",64741-42-0,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c07e25a-b291-405b-86b5-eae4ed54201a/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_0ce61cf6-350e-497a-b7b5-f57cd3da7f3e.html,,,,,, "Naphtha (petroleum), full-range straight-run",64741-42-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c07e25a-b291-405b-86b5-eae4ed54201a/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_0ce61cf6-350e-497a-b7b5-f57cd3da7f3e.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), full-range straight-run",64741-42-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c07e25a-b291-405b-86b5-eae4ed54201a/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_0ce61cf6-350e-497a-b7b5-f57cd3da7f3e.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), full-range straight-run",64741-42-0," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c07e25a-b291-405b-86b5-eae4ed54201a/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_0ce61cf6-350e-497a-b7b5-f57cd3da7f3e.html,,,,,, "Naphtha (petroleum), full-range straight-run",64741-42-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c07e25a-b291-405b-86b5-eae4ed54201a/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_0ce61cf6-350e-497a-b7b5-f57cd3da7f3e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), full-range straight-run",64741-42-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c07e25a-b291-405b-86b5-eae4ed54201a/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_0ce61cf6-350e-497a-b7b5-f57cd3da7f3e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), full-range straight-run",64741-42-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c07e25a-b291-405b-86b5-eae4ed54201a/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_0ce61cf6-350e-497a-b7b5-f57cd3da7f3e.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Distillates (coal tar), upper",65996-91-0,"No acute toxicity was observed after single oral, dermal and inhalational administration of the supporting substances wash oil and creosote to rats thus characterising Distillates (coal tar), upper by analogy as not being acutely toxic. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bdc1ce0-f23c-4a53-81c4-e4d1a6bd146f/documents/IUC5-2ec8f3dd-60b7-4823-80b1-ad98a1e019b9_394f9a38-3c99-4704-818c-aa5e8bb0f341.html,,,,,, "Distillates (coal tar), upper",65996-91-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bdc1ce0-f23c-4a53-81c4-e4d1a6bd146f/documents/IUC5-2ec8f3dd-60b7-4823-80b1-ad98a1e019b9_394f9a38-3c99-4704-818c-aa5e8bb0f341.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (coal tar), upper",65996-91-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bdc1ce0-f23c-4a53-81c4-e4d1a6bd146f/documents/IUC5-2ec8f3dd-60b7-4823-80b1-ad98a1e019b9_394f9a38-3c99-4704-818c-aa5e8bb0f341.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Distillates (coal tar), upper",65996-91-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bdc1ce0-f23c-4a53-81c4-e4d1a6bd146f/documents/IUC5-2ec8f3dd-60b7-4823-80b1-ad98a1e019b9_394f9a38-3c99-4704-818c-aa5e8bb0f341.html,,inhalation,discriminating conc.,"5,000 mg/m3",no adverse effect observed, "2,4-dinitrophenol",51-28-5,"ORAL In a reasonably 28 days well conducted study, weanling rats exposed, NOAEL of 59 mg/kg/day was determined (Kaiser JA. 1964).In 90 days repeated dose study: three independent series of feeding experiments were carried out (SERIES I, II, III). Their food intakes (similar for all the groups) and results were compared with those of unmedicated controls in parallel experiments. Results shows that only in SERIE III, with concentrations of from 0.06 to 0.12 per cent of dinitrophenol in the diet, the growth was definitely retarded and the animals attained a final weight some 75 grams lighter than the controls. At necropsy, and histologically, the tissues of the treated rats were indistinguishable from those of the unmedicated controls, there being no lesions which could be ascribed to the action of the drug. With concentrations of from 0.06 to 0.12 per cent of dinitrophenol in the diet, the growth was definitely retarded and the animals attained a final weight some 75 grams lighter than the controls. At necropsy, and histologically, the tissues of the treated rats were indistinguishable from those of the unmedicated controls, there being no lesions which could be ascribed to the action of the drug. Data obtained from the publication of Mutsuko Koizumi et al., 2001. The study was performed with a dose-finding study (14 days study) and a main study of 28 days. Also an 18 study day was performed on newborn rats but it has not decribed because not considered as a standard 28 days-study.As an unequivocally toxic level, 80 mg/kg/day is appropriate, based on the clear toxic signs with deaths at 80 mg/kg and the slight effects at 60 mg/kg in the dose-finding study. The NOAEL is presumed to be 20 mg/kg/day from the dose-finding study because adverse effects. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47959042-4b75-4bc3-b6f4-43083ca7b484/documents/IUC5-bd40cdfb-e765-4094-939f-fc968d2c8e38_e7788fcb-c022-4b8b-a104-29de368412f5.html,,,,,, "2,4-dinitrophenol",51-28-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47959042-4b75-4bc3-b6f4-43083ca7b484/documents/IUC5-bd40cdfb-e765-4094-939f-fc968d2c8e38_e7788fcb-c022-4b8b-a104-29de368412f5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "2,4-dinitrophenol",51-28-5," ORAL ACUTE TOXICITY LD50 on animals could be defined in the range of 20 (rat) - 81 (rabbit) mg/kg of 2,4-dinitrophenol. More specifically, in a  fairly reliable study 30 > LD50 < 100 mg/kg (Spencer et al., 1948). Anyway, the most conservative value of LD50 is on dog 20 mg/kg (CNR, Drinking Water and Health, Volume 4, 1981). Data on human exposure, as a poisoning clinical studies are available. INHALATION ACUTE TOXICITY The LCLo (lowest published lethal concentration) on dog, tested in 30 months is 300 mg/m^3 of 2,4-dinitrophenol. LD50 could be setted as discriminating dose > 300 mg/kg of 2,4-dinitrophenol. DERMAL ACUTE TOXICITY LD20 (and LOAEL) has been defined on 300 mg/kg on guinea pigs. LD50 could be set as discriminating dose at > 300 mg/kg of 2,4-dinitrophenol. Data on human, as a occupational exposure, on supporting the inhalation route are available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47959042-4b75-4bc3-b6f4-43083ca7b484/documents/IUC5-ebe44bd6-a297-4930-9a9c-8f72bd5b80ce_e7788fcb-c022-4b8b-a104-29de368412f5.html,,,,,, "2,4-dinitrophenol",51-28-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47959042-4b75-4bc3-b6f4-43083ca7b484/documents/IUC5-ebe44bd6-a297-4930-9a9c-8f72bd5b80ce_e7788fcb-c022-4b8b-a104-29de368412f5.html,,oral,LD50,20 mg/kg bw,adverse effect observed, "2,4-dinitrophenol",51-28-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47959042-4b75-4bc3-b6f4-43083ca7b484/documents/IUC5-ebe44bd6-a297-4930-9a9c-8f72bd5b80ce_e7788fcb-c022-4b8b-a104-29de368412f5.html,,dermal,discriminating dose,300 mg/kg bw,adverse effect observed, "2,4-dinitrophenol",51-28-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47959042-4b75-4bc3-b6f4-43083ca7b484/documents/IUC5-ebe44bd6-a297-4930-9a9c-8f72bd5b80ce_e7788fcb-c022-4b8b-a104-29de368412f5.html,,inhalation,discriminating conc.,300 mg/m3,adverse effect observed, Phenylephrine hydrochloride,61-76-7,"Target organs of phenylephrine hydrochloride upon long-term (2-year), repeated exposure via the diet are the liver and prostate and, possibly the lung, in rats (in the affected organs the incidence of inflammation was increased), and the liver (increased incidence of focal cellular change) in mice. These effects occurred from the lowest dose tested in rats, namely 620 mg/kg diet (22 and 26 mg/kg bw/day in male and female rats, respectively) and at the highest dose tested in mice, namely 2,500 mg/kg diet. The lowest dose tested in mice was a NOAEL (1,250 mg/kg diet, corresponding to 130 and 140 mg/kg bw/day in male and female mice, respectively). In the 12-week feeding studies preceding the 2-year studies dietary levels up to 20,000 mg/kg feed were tested. At these higher doses growth retardation (from 1,250 mg/kg feed in rats and and mice) and mortality (from 5,000 g/kg feed in rats and 10,000 mg/kg feed in mice) occurred but no specific target organs were identified. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1dcfb159-9ac8-470d-a541-3f1237ed3fcd/documents/IUC5-f0fa871b-d71d-40e7-97b9-646635796171_ec7d3ffa-3d03-4f4f-90a1-43a363482649.html,,,,,, Phenylephrine hydrochloride,61-76-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1dcfb159-9ac8-470d-a541-3f1237ed3fcd/documents/IUC5-f0fa871b-d71d-40e7-97b9-646635796171_ec7d3ffa-3d03-4f4f-90a1-43a363482649.html,Chronic toxicity – systemic effects,oral,LOAEL,22 mg/kg bw/day,,rat Phenylephrine hydrochloride,61-76-7,A LD50 of 350 mg/kg bw has been determined for female rats in an acute oral toxicity study by Stockhaus and Wick (1969). ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1dcfb159-9ac8-470d-a541-3f1237ed3fcd/documents/IUC5-5d68b235-f40a-4c25-a3a2-9f30c1b81acc_ec7d3ffa-3d03-4f4f-90a1-43a363482649.html,,,,,, Phenylephrine hydrochloride,61-76-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1dcfb159-9ac8-470d-a541-3f1237ed3fcd/documents/IUC5-5d68b235-f40a-4c25-a3a2-9f30c1b81acc_ec7d3ffa-3d03-4f4f-90a1-43a363482649.html,,oral,LD50,350 mg/kg bw,, "Naphtha (petroleum), light catalytic cracked sweetened",92045-59-5,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aff76aac-10f3-430f-9194-505349bdff0a/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_1e83491b-db51-433a-83ba-9658bbaad37a.html,,,,,, "Naphtha (petroleum), light catalytic cracked sweetened",92045-59-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aff76aac-10f3-430f-9194-505349bdff0a/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_1e83491b-db51-433a-83ba-9658bbaad37a.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), light catalytic cracked sweetened",92045-59-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aff76aac-10f3-430f-9194-505349bdff0a/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_1e83491b-db51-433a-83ba-9658bbaad37a.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), light catalytic cracked sweetened",92045-59-5," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aff76aac-10f3-430f-9194-505349bdff0a/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_1e83491b-db51-433a-83ba-9658bbaad37a.html,,,,,, "Naphtha (petroleum), light catalytic cracked sweetened",92045-59-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aff76aac-10f3-430f-9194-505349bdff0a/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_1e83491b-db51-433a-83ba-9658bbaad37a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light catalytic cracked sweetened",92045-59-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aff76aac-10f3-430f-9194-505349bdff0a/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_1e83491b-db51-433a-83ba-9658bbaad37a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light catalytic cracked sweetened",92045-59-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aff76aac-10f3-430f-9194-505349bdff0a/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_1e83491b-db51-433a-83ba-9658bbaad37a.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Solvent naphtha (coal), xylene-styrene cut",85536-20-5," No toxicological findings were detected in mice and rats orally treated with toluene. NOAEL for toluene was considered to be 625 mg/kg/day for both mice and rats. Repeated administration of benzene to rats is associated with adverse effects in the haemotopoietic system. NOAEL for males was 200 mg/kg. No NOAEL was established for females. LOALE for females was 25 mg/kg/day (lowest dose tested). In repeated dose studies, the principle effects of xylenes were adaptive changes in the liver, changes in kidney and liver weights, body weight changes and minimal nephropathy in females. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e27a1f90-aec1-41e0-9d8a-1fce289a07d0/documents/IUC5-1db6dc9b-811b-4552-b26e-b41c614a5d57_e1363dd6-c994-4e69-8933-f409710f054b.html,,,,,, "Solvent naphtha (coal), xylene-styrene cut",85536-20-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e27a1f90-aec1-41e0-9d8a-1fce289a07d0/documents/IUC5-1db6dc9b-811b-4552-b26e-b41c614a5d57_e1363dd6-c994-4e69-8933-f409710f054b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,, "Solvent naphtha (coal), xylene-styrene cut",85536-20-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e27a1f90-aec1-41e0-9d8a-1fce289a07d0/documents/IUC5-1db6dc9b-811b-4552-b26e-b41c614a5d57_e1363dd6-c994-4e69-8933-f409710f054b.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"3,515 mg/m3",, "Solvent naphtha (coal), xylene-styrene cut",85536-20-5,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyInformation.KeyInformation): In animal studies xylene isomers, ethylbenzene and mixed xylenes exhibit low acute toxicity by oral and dermal routes with the reported LD50 values all exceeding 2000 mg/kg bw. Mixed xylene is considered harmful by inhalation. In humans critical effects of xylenes are irritation and CNS effects, with the overall NOAEC inhalation for the latter effect being 300 mg/m3. Data on the components benzene and toluene indicate that no classification is warranted on the basis of acute lethality following exposure via oral, dermal or inhalation routes. Although toluene produces unsteady gait and other indications of neurobehavioural activity at concentrations < 20 mg/L the levels in mixed xylenes are not sufficient to warrant classification. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e27a1f90-aec1-41e0-9d8a-1fce289a07d0/documents/IUC5-93736606-2dc4-40a5-a423-60098e4b0fc0_e1363dd6-c994-4e69-8933-f409710f054b.html,,,,,, "Solvent naphtha (coal), xylene-styrene cut",85536-20-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e27a1f90-aec1-41e0-9d8a-1fce289a07d0/documents/IUC5-93736606-2dc4-40a5-a423-60098e4b0fc0_e1363dd6-c994-4e69-8933-f409710f054b.html,,inhalation,LC50,"43,767 mg/m3",no adverse effect observed, Benzol forerunnings (coal),65996-88-5, Benzene causes adverse effects on the haematopoietic system of animals and in humans. This resulted in a harmonised classification as repaeted dose toxicant (STOT RE1). Studies on CS2 have revealed adverse effects on the hematological system and neuropathological effects. This also resulted in a harmonised classification as repaeted dose toxicant (STOT RE1).    ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13cb26eb-e1fd-468d-a62b-294dc17e3d19/documents/eba0a159-a131-43a0-bb7c-2752247b0fac_e4f16694-f56a-46f8-bedf-49f951d95e92.html,,,,,, Benzol forerunnings (coal),65996-88-5," An assesment of acute oral, dermal and inhalation toxicity was made based on the identified compounds and as a high level of identification was achieved, this approach is considered justified. Some components were found to be non-toxic within the CLP classification limits based on the available data * Benzene (oral LD50 > 2000 mg/kg; dermal LD50> 8260 mg/kg and inhalation 4 hour LC50 >44.5 mg/L) * Toluene (oral LD50 > 5000 mg/kg; dermal LD50> 5000 mg/kg and inhalation 4 hour LC50 >20 mg/L) * 1,3 -butadiene (oral LD50 5480 mg/kg and inhalation 4 hour LC50 285 mg/L ) A literature search also revealed some components exhibited some toxicity, although sometimes above CLP classification limits: * Carbon disulphide (oral LD50 1200 mg/kg and inhalation 4 hour LC50 10.35 mg/L) * Pentadiene: no data found * Cyclopentadiene (oral LD50 113 mg/kg and dermal LD50 430 mg/kg) * Dicyclopentadiene (oral LD50 353 mg/kg; dermal LD50 5080 mg/kg and inhalation 4 hour LC50 1.972 mg/l ) Therefore an ATE calculation was performed with 3% 1,3 butadiene, 5% 1,4 pentadiene, 25% CS2, 56% (di)cyclopentadiene, 6% benzene and 5% unknown components. In case of (di)cyclopentadiene a worst case approach was followed where the most toxic of both compounds was assumed for each exposure route. This because the two components are interchangeable depending on the circumstances, although the on-site isolated intermediate generally contains dicyclopentadiene. Where no values were available this was calculated as unknown toxicity. ATE oral 194 mg/kg => Acute tox. cat 3 ATE dermal 476 mg/kg => Acute tox. cat 3 ATE inhalation 3.24 mg/L(4h) => Acute tox. cat 3 In addition benzol forerunnings (coal) consists of hydrocarbons with a low boiling point and of low viscosity, therefore a classification for aspiration hazard is also justified. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13cb26eb-e1fd-468d-a62b-294dc17e3d19/documents/fabd2893-0104-4a67-92c2-31caddf67a0e_e4f16694-f56a-46f8-bedf-49f951d95e92.html,,,,,, "Residues (petroleum), steam-cracked light, arom.",102110-55-4,"Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene / n-hexane - when present at 10%). Adequate information is available on the constituents to characterise the repeated dermal hazards of these streams. Adequate information is available on the constituents to characterise the repeated inhalation hazards of these streams. Adequate information is available on the constituents to characterise the repeated oral hazards of these streams. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea0d7e05-c390-46e7-b35f-a716a43c4b7b/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_d9d19da5-64ce-45f6-af76-45dfd0895604.html,,,,,, "Residues (petroleum), steam-cracked light, arom.",102110-55-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea0d7e05-c390-46e7-b35f-a716a43c4b7b/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_d9d19da5-64ce-45f6-af76-45dfd0895604.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Residues (petroleum), steam-cracked light, arom.",102110-55-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea0d7e05-c390-46e7-b35f-a716a43c4b7b/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_d9d19da5-64ce-45f6-af76-45dfd0895604.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Residues (petroleum), steam-cracked light, arom.",102110-55-4,"Available data for one stream within this category (CAS 68516-20-1) and data on specific constituents (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Adequate information is available to characterise the short-term hazards of these streams. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea0d7e05-c390-46e7-b35f-a716a43c4b7b/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_d9d19da5-64ce-45f6-af76-45dfd0895604.html,,,,,, "Residues (petroleum), steam-cracked light, arom.",102110-55-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea0d7e05-c390-46e7-b35f-a716a43c4b7b/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_d9d19da5-64ce-45f6-af76-45dfd0895604.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), steam-cracked light, arom.",102110-55-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea0d7e05-c390-46e7-b35f-a716a43c4b7b/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_d9d19da5-64ce-45f6-af76-45dfd0895604.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), steam-cracked light, arom.",102110-55-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea0d7e05-c390-46e7-b35f-a716a43c4b7b/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_d9d19da5-64ce-45f6-af76-45dfd0895604.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, Norethisterone,68-22-4,"Norethisterone is a synthetic sex hormone and active ingredient of approved drugs since several decades. Norethisterone belongs to the category “steroidal progestins” and has progestogenic properties resembling those of the naturally occuring progesterone but is a more potent inhibitor of ovulation. Apart from the data on norethisterone, information from its ester derivates (norethisterone enanthate and acetate) can be used for characterization of the biological activity of progestin, because both esters are rapidly cleaved within the mammalian organism and thus, norethisterone is the systemically active metabolite irrespective of the form which is administered.   No repeated dose toxicity studies were conducted with ZK 5378 (norethisterone). But data on its ester derivatives norethisterone acetate and/or norethisterone enantate can be also used for the toxicological characterization, because both esters are rapidly cleaved in vivo and norethisterone as the actual pharmacologically active metabolite is released. However, since the first introduction of drug preparations containing this steroidal progestin dates back more than five decades, the major part of its preclinical characterization does not fulfil the requirements applicable today to studies used for safety assessment. However, these limitations are more than compensated for by the vast amount of clinical experience gained with norethisterone and its esters in their continued and widespread therapeutic use. Therefore in conclusion the results of the preclinical characterisation of norethisterone and its esters confirm its properties as a steroidal progestin.   As known from an extensive data base animal experiments with progestins are only of limited predictive value for qualitative and even more for quanatitative extrapolation to humans because of a large diversity in factors responsible for endocrine regulation between experimental animals and man. Therefore the most sensitive endpoint that would be considered in risk assessment is the lowest oral daily dose with pharmacological effects in humans of norethisterone. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a09dbe6-519e-4b1f-b00f-1a554789ff4e/documents/IUC5-ebaca88e-71eb-4677-8aea-7a9c72d21546_ab29ae88-bba1-425b-bc95-88ffd038c483.html,,,,,, Norethisterone,68-22-4,"Norethisterone is a synthetic sex hormone and active ingredient of approved drugs since several decades. Norethisterone belongs to the category “steroidal progestins” and has progestogenic properties resembling those of the naturally occuring progesterone but is a more potent inhibitor of ovulation. Apart from the data on norethisterone, information from its ester derivates (norethisterone enanthate and acetate) can be used for characterization of the biological activity of progestin, because both esters are rapidly cleaved within the mammalian organism and thus, norethisterone is the systemically active metabolite irrespective of the form which is administered.   No acute toxicity studies were conducted with ZK 5378 (norethisterone). But data on its ester derivatives norethisterone acetate and norethisterone enantate can be also used for the toxicological characterization, because both esters are rapidly cleaved in vivo and norethisterone as the actual pharmacologically active metabolite is released. Thus for the oral route results of studies conducted with norethisterone enanthate (ZK 5410) are taken as surrogate of norethisterone. For the dermal route no studies are available for the esters, too. Because the substance has shown to be non-toxic via the oral route with an LD50 > 3000 mg/kg and no compound-related clinical signs, it may be expected with high certainty that it is also non-toxic via the dermal route.   Acute oral toxicity The single oral administration of the surrogate to 10 rats/sex at a dose of 3000 mg/kg was tolerated without any compound-related clinical signs. One female rat died on day 3. In all sacrificed animals no macroscopic pathological signs were observed. The acute oral toxicity of the test item in rats is >3000 mg/kg body weight.   Acute dermal toxicity No acute toxicity studies were conducted with ZK 5378 (norethisterone). The discriminating dose is predicted to be in the same order of magnitude as reported for the oral route. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a09dbe6-519e-4b1f-b00f-1a554789ff4e/documents/IUC5-4aa4a21d-db57-45bd-8ca9-8a2bf514aa9e_ab29ae88-bba1-425b-bc95-88ffd038c483.html,,,,,, Norethisterone,68-22-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a09dbe6-519e-4b1f-b00f-1a554789ff4e/documents/IUC5-4aa4a21d-db57-45bd-8ca9-8a2bf514aa9e_ab29ae88-bba1-425b-bc95-88ffd038c483.html,,oral,discriminating dose,"3,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), heavy straight-run",64741-41-9,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92342e6e-38a1-4395-8a25-ff7112ed8015/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_2bcd931e-5f79-47be-82f4-f7095590c860.html,,,,,, "Naphtha (petroleum), heavy straight-run",64741-41-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92342e6e-38a1-4395-8a25-ff7112ed8015/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_2bcd931e-5f79-47be-82f4-f7095590c860.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), heavy straight-run",64741-41-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92342e6e-38a1-4395-8a25-ff7112ed8015/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_2bcd931e-5f79-47be-82f4-f7095590c860.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), heavy straight-run",64741-41-9," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92342e6e-38a1-4395-8a25-ff7112ed8015/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_2bcd931e-5f79-47be-82f4-f7095590c860.html,,,,,, "Naphtha (petroleum), heavy straight-run",64741-41-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92342e6e-38a1-4395-8a25-ff7112ed8015/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_2bcd931e-5f79-47be-82f4-f7095590c860.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), heavy straight-run",64741-41-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92342e6e-38a1-4395-8a25-ff7112ed8015/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_2bcd931e-5f79-47be-82f4-f7095590c860.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), heavy straight-run",64741-41-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92342e6e-38a1-4395-8a25-ff7112ed8015/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_2bcd931e-5f79-47be-82f4-f7095590c860.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha (petroleum), light steam-cracked",64742-83-2,"Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene / n-hexane - when present at 10%). Adequate information is available on the constituents to characterise the repeated dermal hazards of these streams. Adequate information is available on the constituents to characterise the repeated inhalation hazards of these streams. Adequate information is available on the constituents to characterise the repeated oral hazards of these streams. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e07594bd-fe11-4a13-b3dd-c51a842bdc20/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_47241e16-5402-4afd-8531-7770ab232948.html,,,,,, "Naphtha (petroleum), light steam-cracked",64742-83-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e07594bd-fe11-4a13-b3dd-c51a842bdc20/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_47241e16-5402-4afd-8531-7770ab232948.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Naphtha (petroleum), light steam-cracked",64742-83-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e07594bd-fe11-4a13-b3dd-c51a842bdc20/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_47241e16-5402-4afd-8531-7770ab232948.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Naphtha (petroleum), light steam-cracked",64742-83-2,"Available data for one stream within this category (CAS 68516-20-1) and data on specific constituents (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Adequate information is available to characterise the short-term hazards of these streams. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e07594bd-fe11-4a13-b3dd-c51a842bdc20/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_47241e16-5402-4afd-8531-7770ab232948.html,,,,,, "Naphtha (petroleum), light steam-cracked",64742-83-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e07594bd-fe11-4a13-b3dd-c51a842bdc20/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_47241e16-5402-4afd-8531-7770ab232948.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light steam-cracked",64742-83-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e07594bd-fe11-4a13-b3dd-c51a842bdc20/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_47241e16-5402-4afd-8531-7770ab232948.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light steam-cracked",64742-83-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e07594bd-fe11-4a13-b3dd-c51a842bdc20/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_47241e16-5402-4afd-8531-7770ab232948.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, "Naphtha (petroleum), hydrotreated light steam-cracked",92045-57-3,"Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene / n-hexane - when present at 10%). Adequate information is available on the constituents to characterise the repeated dermal hazards of these streams. Adequate information is available on the constituents to characterise the repeated inhalation hazards of these streams. Adequate information is available on the constituents to characterise the repeated oral hazards of these streams. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10b54d6a-ef97-43e6-bc38-611293b8742f/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_cba7b4bb-9189-4c53-ba76-384feee1e530.html,,,,,, "Naphtha (petroleum), hydrotreated light steam-cracked",92045-57-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10b54d6a-ef97-43e6-bc38-611293b8742f/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_cba7b4bb-9189-4c53-ba76-384feee1e530.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Naphtha (petroleum), hydrotreated light steam-cracked",92045-57-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10b54d6a-ef97-43e6-bc38-611293b8742f/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_cba7b4bb-9189-4c53-ba76-384feee1e530.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Naphtha (petroleum), hydrotreated light steam-cracked",92045-57-3,"Available data for one stream within this category (CAS 68516-20-1) and data on specific constituents (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Adequate information is available to characterise the short-term hazards of these streams. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10b54d6a-ef97-43e6-bc38-611293b8742f/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_cba7b4bb-9189-4c53-ba76-384feee1e530.html,,,,,, "Naphtha (petroleum), hydrotreated light steam-cracked",92045-57-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10b54d6a-ef97-43e6-bc38-611293b8742f/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_cba7b4bb-9189-4c53-ba76-384feee1e530.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), hydrotreated light steam-cracked",92045-57-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10b54d6a-ef97-43e6-bc38-611293b8742f/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_cba7b4bb-9189-4c53-ba76-384feee1e530.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), hydrotreated light steam-cracked",92045-57-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10b54d6a-ef97-43e6-bc38-611293b8742f/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_cba7b4bb-9189-4c53-ba76-384feee1e530.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, Gasoline,86290-81-5,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f76a4d29-41f9-465f-98f8-587761fe873a/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_c330c6af-5f4d-4d9b-9c6d-87d45bd1229a.html,,,,,, Gasoline,86290-81-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f76a4d29-41f9-465f-98f8-587761fe873a/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_c330c6af-5f4d-4d9b-9c6d-87d45bd1229a.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse Gasoline,86290-81-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f76a4d29-41f9-465f-98f8-587761fe873a/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_c330c6af-5f4d-4d9b-9c6d-87d45bd1229a.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat Gasoline,86290-81-5," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f76a4d29-41f9-465f-98f8-587761fe873a/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_c330c6af-5f4d-4d9b-9c6d-87d45bd1229a.html,,,,,, Gasoline,86290-81-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f76a4d29-41f9-465f-98f8-587761fe873a/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_c330c6af-5f4d-4d9b-9c6d-87d45bd1229a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Gasoline,86290-81-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f76a4d29-41f9-465f-98f8-587761fe873a/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_c330c6af-5f4d-4d9b-9c6d-87d45bd1229a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Gasoline,86290-81-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f76a4d29-41f9-465f-98f8-587761fe873a/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_c330c6af-5f4d-4d9b-9c6d-87d45bd1229a.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, reaction mass of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-2H -isothiazol-3-one,55965-84-9,"C(M)IT/MIT was tested in several oral repeated dose toxicity studies in rabbits, rats and dogs for 4 weeks and 3 months. Two 90-day dermal repeated dose toxicity studies were performed with C(M)IT/MIT in rabbit and rat. One 90 Day inhalation study in the rat was performed with CMIT/MIT. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93fb4bce-ee4a-497c-a732-1477ecf9c154/documents/f592db70-d131-4c31-bbd6-a7d262cc62cb_b0a81733-35a0-4725-9137-57e19054452c.html,,,,,, reaction mass of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-2H -isothiazol-3-one,55965-84-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93fb4bce-ee4a-497c-a732-1477ecf9c154/documents/f592db70-d131-4c31-bbd6-a7d262cc62cb_b0a81733-35a0-4725-9137-57e19054452c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,22 mg/kg bw/day,,dog reaction mass of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-2H -isothiazol-3-one,55965-84-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93fb4bce-ee4a-497c-a732-1477ecf9c154/documents/f592db70-d131-4c31-bbd6-a7d262cc62cb_b0a81733-35a0-4725-9137-57e19054452c.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,0.1 mg/kg bw/day,,rat reaction mass of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-2H -isothiazol-3-one,55965-84-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93fb4bce-ee4a-497c-a732-1477ecf9c154/documents/f592db70-d131-4c31-bbd6-a7d262cc62cb_b0a81733-35a0-4725-9137-57e19054452c.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,2.36 mg/m3,,rat reaction mass of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-2H -isothiazol-3-one,55965-84-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93fb4bce-ee4a-497c-a732-1477ecf9c154/documents/f592db70-d131-4c31-bbd6-a7d262cc62cb_b0a81733-35a0-4725-9137-57e19054452c.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.1 ,adverse effect observed,rat reaction mass of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-2H -isothiazol-3-one,55965-84-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93fb4bce-ee4a-497c-a732-1477ecf9c154/documents/f592db70-d131-4c31-bbd6-a7d262cc62cb_b0a81733-35a0-4725-9137-57e19054452c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,2.36 mg/m3,adverse effect observed,rat reaction mass of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-2H -isothiazol-3-one,55965-84-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93fb4bce-ee4a-497c-a732-1477ecf9c154/documents/68bc65d3-7240-43c8-9463-300b07a2664f_b0a81733-35a0-4725-9137-57e19054452c.html,,oral,LD50,457 mg/kg bw,adverse effect observed, reaction mass of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-2H -isothiazol-3-one,55965-84-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93fb4bce-ee4a-497c-a732-1477ecf9c154/documents/68bc65d3-7240-43c8-9463-300b07a2664f_b0a81733-35a0-4725-9137-57e19054452c.html,,dermal,LD50,660 mg/kg bw,adverse effect observed, reaction mass of 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-2H -isothiazol-3-one,55965-84-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93fb4bce-ee4a-497c-a732-1477ecf9c154/documents/68bc65d3-7240-43c8-9463-300b07a2664f_b0a81733-35a0-4725-9137-57e19054452c.html,,inhalation,LC50,1.23 mg/m3,adverse effect observed, "Gases (petroleum), butane splitter overheads",68477-69-0,"After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and in humans. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/656fdb5a-5e4b-40f0-a5c6-f00d77dafe41/documents/c056898b-bfcd-467a-81f5-932d319271c5_6a2b892b-ab4a-4ae7-87f7-8d29a57c959d.html,,,,,, "Gases (petroleum), butane splitter overheads",68477-69-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/656fdb5a-5e4b-40f0-a5c6-f00d77dafe41/documents/c056898b-bfcd-467a-81f5-932d319271c5_6a2b892b-ab4a-4ae7-87f7-8d29a57c959d.html,Chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Gases (petroleum), butane splitter overheads",68477-69-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/656fdb5a-5e4b-40f0-a5c6-f00d77dafe41/documents/c056898b-bfcd-467a-81f5-932d319271c5_6a2b892b-ab4a-4ae7-87f7-8d29a57c959d.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human (epidemiological findings) "Gases (petroleum), butane splitter overheads",68477-69-0," Benzene does not pose an acute hazard following ingestion (oral LD50 > 2000 mg/kg), skin contact (dermal LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/656fdb5a-5e4b-40f0-a5c6-f00d77dafe41/documents/d5c4a791-dd55-400f-823a-3a66c0f7cf91_6a2b892b-ab4a-4ae7-87f7-8d29a57c959d.html,,,,,, "Gases (petroleum), butane splitter overheads",68477-69-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/656fdb5a-5e4b-40f0-a5c6-f00d77dafe41/documents/d5c4a791-dd55-400f-823a-3a66c0f7cf91_6a2b892b-ab4a-4ae7-87f7-8d29a57c959d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gases (petroleum), butane splitter overheads",68477-69-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/656fdb5a-5e4b-40f0-a5c6-f00d77dafe41/documents/d5c4a791-dd55-400f-823a-3a66c0f7cf91_6a2b892b-ab4a-4ae7-87f7-8d29a57c959d.html,,dermal,LD50,"8,260 mg/kg bw",no adverse effect observed, "Gases (petroleum), butane splitter overheads",68477-69-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/656fdb5a-5e4b-40f0-a5c6-f00d77dafe41/documents/d5c4a791-dd55-400f-823a-3a66c0f7cf91_6a2b892b-ab4a-4ae7-87f7-8d29a57c959d.html,,inhalation,LC50,"43,767 mg/m3",no adverse effect observed, "Gases (petroleum), catalytic-cracked gas oil depropanizer bottoms, C4-rich acid-free",68477-71-4,"Only one stream of the Other Petroleum Gases category has been tested but this and the main components of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. The mammalian toxicity effects of this category will be not driven by the content of benzene as the latter is present at levels of <0.3%, however, the category may contain carbon monoxide which could trigger classification. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de0359c4-5ca1-41e5-93f9-d64c018d4be2/documents/IUC5-5a55592f-8b72-4e82-bb98-63a06aaf7d45_a74b9369-b7af-4332-9902-518e5adc4611.html,,,,,, "Gases (petroleum), catalytic-cracked gas oil depropanizer bottoms, C4-rich acid-free",68477-71-4,"Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the component substances. Across species, main component gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene as the latter is present at levels of <0.3%, however, the category may contain carbon monoxide and/or hydrogen sulphide which could trigger classification. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de0359c4-5ca1-41e5-93f9-d64c018d4be2/documents/IUC5-02176948-0c88-42d0-83b5-5edbdb9e65a5_a74b9369-b7af-4332-9902-518e5adc4611.html,,,,,, "Gases (petroleum), refinery blend",68783-07-3," Only one stream (Liquified Petroleum Gases CAS 68476 -85 -7) of the Other Petroleum Gases category has been tested but this and the main constituents of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and humans. The mammalian toxicity effects of this category will be driven by the content of benzene if the latter is present at levels of >10%. Additionally, the category may contain carbon monoxide which could trigger classification. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5eb7b66b-ce67-4231-b4f5-f4b07f481072/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_607a3187-eee6-4ac9-a230-c7be6bd030fd.html,,,,,, "Gases (petroleum), refinery blend",68783-07-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5eb7b66b-ce67-4231-b4f5-f4b07f481072/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_607a3187-eee6-4ac9-a230-c7be6bd030fd.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"7,214 mg/m3",,rat "Gases (petroleum), refinery blend",68783-07-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5eb7b66b-ce67-4231-b4f5-f4b07f481072/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_607a3187-eee6-4ac9-a230-c7be6bd030fd.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"8,600 mg/m3",adverse effect observed,rat "Gases (petroleum), refinery blend",68783-07-3," Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the constituents. Across species, main constituent gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene in streams where it is present at levels of <1%. However, some streams in this category may contain benzene levels >1% or carbon monoxide which could trigger classification. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5eb7b66b-ce67-4231-b4f5-f4b07f481072/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_607a3187-eee6-4ac9-a230-c7be6bd030fd.html,,,,,, "Gases (petroleum), refinery blend",68783-07-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5eb7b66b-ce67-4231-b4f5-f4b07f481072/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_607a3187-eee6-4ac9-a230-c7be6bd030fd.html,,inhalation,LC50,"22,948 mg/m3",no adverse effect observed, "Foots oil (petroleum), hydrotreated",92045-12-0,"Based on 28-day read-across studies conducted using other lubricant base oils, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEL (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3.  The 90-day dermal studies gave a NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study that tested distillate aromatic extracts. Sufficiently refined foots oils (DMSO extract IP 346 < 3%) are not classified according to DSD for repeat-dose toxicity. Insufficiently refined foots oils (DMSO extract IP 346 ≥ 3%) are classified as carcinogenic. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82d8e8a8-16bc-4ff7-872c-6e73b0bb1e07/documents/f0fc84c3-ab5d-4ef9-8804-26fe613f95e2_da57416f-56a2-4210-8a63-f2e5aba94d75.html,,,,,, "Foots oil (petroleum), hydrotreated",92045-12-0,"There is no acute toxicity data available for foots oils. However, read across data from other lubricant base oils is available and used for the foots oils category. Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc., 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Nine additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. The acute inhalation LC50 for other lubricant base oils is >5.0 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82d8e8a8-16bc-4ff7-872c-6e73b0bb1e07/documents/e219cafd-6890-427c-8a75-4a0083206f6b_da57416f-56a2-4210-8a63-f2e5aba94d75.html,,,,,, "Gases (petroleum), catalytic reformed naphtha stripper overheads",68477-77-0,"Only one stream (Liquified Petroleum Gases CAS 68476 -85 -7) of the Other Petroleum Gases category has been tested but this and the main constituents of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and humans. The mammalian toxicity effects of this category will be driven by the content of benzene if the latter is present at levels of >10%. Additionally, the category may contain carbon monoxide which could trigger classification.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65c8ad86-5690-40df-8ebb-12583718e1e2/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_dc521f32-ef35-41be-b632-c810027358c6.html,,,,,, "Gases (petroleum), catalytic reformed naphtha stripper overheads",68477-77-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65c8ad86-5690-40df-8ebb-12583718e1e2/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_dc521f32-ef35-41be-b632-c810027358c6.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"7,214 mg/m3",,rat "Gases (petroleum), catalytic reformed naphtha stripper overheads",68477-77-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65c8ad86-5690-40df-8ebb-12583718e1e2/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_dc521f32-ef35-41be-b632-c810027358c6.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"8,600 mg/m3",adverse effect observed,rat "Gases (petroleum), catalytic reformed naphtha stripper overheads",68477-77-0,"Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the constituents. Across species, main constituent gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene in streams where it is present at levels of <1%. However, some streams in this category may contain benzene levels >1% or carbon monoxide which could trigger classification. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65c8ad86-5690-40df-8ebb-12583718e1e2/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_dc521f32-ef35-41be-b632-c810027358c6.html,,,,,, "Gases (petroleum), catalytic reformed naphtha stripper overheads",68477-77-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65c8ad86-5690-40df-8ebb-12583718e1e2/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_dc521f32-ef35-41be-b632-c810027358c6.html,,inhalation,LC50,"22,948 mg/m3",no adverse effect observed, "Hydrocarbons, C2-4, C3-rich",68476-49-3,"After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and in humans. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b5fa09b-f4a6-4097-bc75-7a4d328dbfc1/documents/0a65e697-ca75-4710-87c1-abe636e0b74a_3c4f701e-21ed-4a94-99ad-39b61bce0f86.html,,,,,, "Hydrocarbons, C2-4, C3-rich",68476-49-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b5fa09b-f4a6-4097-bc75-7a4d328dbfc1/documents/0a65e697-ca75-4710-87c1-abe636e0b74a_3c4f701e-21ed-4a94-99ad-39b61bce0f86.html,Chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Hydrocarbons, C2-4, C3-rich",68476-49-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b5fa09b-f4a6-4097-bc75-7a4d328dbfc1/documents/0a65e697-ca75-4710-87c1-abe636e0b74a_3c4f701e-21ed-4a94-99ad-39b61bce0f86.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human (epidemiological findings) "Hydrocarbons, C2-4, C3-rich",68476-49-3," Benzene does not pose an acute hazard following ingestion (oral LD50 > 2000 mg/kg), skin contact (dermal LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b5fa09b-f4a6-4097-bc75-7a4d328dbfc1/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_3c4f701e-21ed-4a94-99ad-39b61bce0f86.html,,,,,, "Hydrocarbons, C2-4, C3-rich",68476-49-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b5fa09b-f4a6-4097-bc75-7a4d328dbfc1/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_3c4f701e-21ed-4a94-99ad-39b61bce0f86.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C2-4, C3-rich",68476-49-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b5fa09b-f4a6-4097-bc75-7a4d328dbfc1/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_3c4f701e-21ed-4a94-99ad-39b61bce0f86.html,,dermal,LD50,"8,260 mg/kg bw",no adverse effect observed, "Hydrocarbons, C2-4, C3-rich",68476-49-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b5fa09b-f4a6-4097-bc75-7a4d328dbfc1/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_3c4f701e-21ed-4a94-99ad-39b61bce0f86.html,,inhalation,LC50,"43,767 mg/m3",no adverse effect observed, "(R)-α-phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate",25383-07-7," Key study: Test method according to EU Method B.7. GLP study. The ""No Observed Effect Level"" (NOEL) was considered to be 150 mg/kg/day (28-day oral toxicity study in rats). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ce22688-541d-4ddf-846a-af6b15faf0dc/documents/IUC5-f2411eb4-99a0-44a8-bc0e-c0314a067eb4_00318f9d-e5fb-4967-a7df-a348af2236c3.html,,,,,, "(R)-α-phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate",25383-07-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ce22688-541d-4ddf-846a-af6b15faf0dc/documents/IUC5-f2411eb4-99a0-44a8-bc0e-c0314a067eb4_00318f9d-e5fb-4967-a7df-a348af2236c3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "(R)-α-phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate",25383-07-7, Acute toxicity: oral. Key study: Test method according to EU Method B.1 and OECD Guideline 401. GLP study. The oral LD50 of the test article in Sprague-Dawley rats was > 2000 mg/kg bw. Acute toxicity: dermal. Key study: Test method according to EU Method B.3 and OECD Guideline 402. GLP study. The LD50 value of test article in Sprague-Dawley rats by dermal route at 24 h exposure period is > 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ce22688-541d-4ddf-846a-af6b15faf0dc/documents/IUC5-b73f96de-b49d-4b4a-92ac-5ebd1861b5c9_00318f9d-e5fb-4967-a7df-a348af2236c3.html,,,,,, "(R)-α-phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate",25383-07-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ce22688-541d-4ddf-846a-af6b15faf0dc/documents/IUC5-b73f96de-b49d-4b4a-92ac-5ebd1861b5c9_00318f9d-e5fb-4967-a7df-a348af2236c3.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "(R)-α-phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate",25383-07-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ce22688-541d-4ddf-846a-af6b15faf0dc/documents/IUC5-b73f96de-b49d-4b4a-92ac-5ebd1861b5c9_00318f9d-e5fb-4967-a7df-a348af2236c3.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), dewaxed light paraffinic, hydrotreated",91995-40-3,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb5fbe0b-1308-46cd-a0f5-5b13a79096cd/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_bccab436-f4cf-4127-9f64-5abccf886fba.html,,,,,, "Distillates (petroleum), dewaxed light paraffinic, hydrotreated",91995-40-3,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb5fbe0b-1308-46cd-a0f5-5b13a79096cd/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_bccab436-f4cf-4127-9f64-5abccf886fba.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Distillates (petroleum), dewaxed light paraffinic, hydrotreated",91995-40-3,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb5fbe0b-1308-46cd-a0f5-5b13a79096cd/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_bccab436-f4cf-4127-9f64-5abccf886fba.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Distillates (petroleum), dewaxed light paraffinic, hydrotreated",91995-40-3,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb5fbe0b-1308-46cd-a0f5-5b13a79096cd/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_bccab436-f4cf-4127-9f64-5abccf886fba.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Distillates (petroleum), dewaxed light paraffinic, hydrotreated",91995-40-3,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb5fbe0b-1308-46cd-a0f5-5b13a79096cd/documents/73761dae-46d6-428e-8e40-e5cc70088d96_bccab436-f4cf-4127-9f64-5abccf886fba.html,,,,,, "Distillates (petroleum), dewaxed light paraffinic, hydrotreated",91995-40-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb5fbe0b-1308-46cd-a0f5-5b13a79096cd/documents/73761dae-46d6-428e-8e40-e5cc70088d96_bccab436-f4cf-4127-9f64-5abccf886fba.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), dewaxed light paraffinic, hydrotreated",91995-40-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb5fbe0b-1308-46cd-a0f5-5b13a79096cd/documents/73761dae-46d6-428e-8e40-e5cc70088d96_bccab436-f4cf-4127-9f64-5abccf886fba.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), dewaxed light paraffinic, hydrotreated",91995-40-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb5fbe0b-1308-46cd-a0f5-5b13a79096cd/documents/73761dae-46d6-428e-8e40-e5cc70088d96_bccab436-f4cf-4127-9f64-5abccf886fba.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Methyloxirane,75-56-9,"Several long-term studies have been conducted for this substance and the only consistent, toxicologically significant, non-neoplastic findings are localized to the site of application. In rodent chronic inhalation bioassays, propylene oxide vapor produced upper respiratory tract clinical signs (e.g. dyspnea, gasping, rhinitis) and lesions (e.g. nasal cavity edema and inflammation, degeneration and necrosis of nasal cavity mucosal epithelium, squamous metaplasia and hyperplasia of the respiratory epithelium of the nasal mucosa and epithelium of the mucosal glands). In a chronic oral study conducted in the rat, the principal non-neoplastic findings associated with gavage dosages were reactive changes (epithelial hyperplasia) in the squamous epithelium of the forestomach. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dddc11ef-503c-4e1c-9d7a-fa6ae72a0b22/documents/IUC5-c08f37ed-3825-4392-9794-07ed577df076_d0ed4410-d8cb-447b-9ad0-cc33a6474b9c.html,,,,,, Methyloxirane,75-56-9,"Acute toxicity data by oral, inhalation and dermal route indicate that propylene oxide is harmful by all routes. The studies for the oral and inhalation route were performed in rats comparable to the respective OECD guidelines 401 and 403, giving an oral LD50 of 382-587 mg/kg bw and an LC50 of 9.95 mg/L. For the dermal route data also indicate that PO is also harmful by this route, with an LD50 of 950 mg/kg bw (using rabbits). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dddc11ef-503c-4e1c-9d7a-fa6ae72a0b22/documents/IUC5-587696bc-40c2-42d3-be78-d45825e1d785_d0ed4410-d8cb-447b-9ad0-cc33a6474b9c.html,,,,,, Methyloxirane,75-56-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dddc11ef-503c-4e1c-9d7a-fa6ae72a0b22/documents/IUC5-587696bc-40c2-42d3-be78-d45825e1d785_d0ed4410-d8cb-447b-9ad0-cc33a6474b9c.html,,oral,LD50,382 mg/kg bw,, Methyloxirane,75-56-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dddc11ef-503c-4e1c-9d7a-fa6ae72a0b22/documents/IUC5-587696bc-40c2-42d3-be78-d45825e1d785_d0ed4410-d8cb-447b-9ad0-cc33a6474b9c.html,,dermal,LD50,950 mg/kg bw,, Methyloxirane,75-56-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dddc11ef-503c-4e1c-9d7a-fa6ae72a0b22/documents/IUC5-587696bc-40c2-42d3-be78-d45825e1d785_d0ed4410-d8cb-447b-9ad0-cc33a6474b9c.html,,inhalation,LC50,"9,950 mg/m3",, "1-(2,4-dimethylphenylazo)-2-naphthol",3118-97-6," Repeated dose toxicity: oral NOAEL was considered to be 30mg/kg bw/day when male and female rats were exposed to FD&C Red No. 32 repeatedly by oral (feed). Repeated dose toxicity: inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol, which is reported as 0.000001559 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical 1 -[(2,4 -dimethyl phenyl)diazenyl]-2 -naphthol is highly unlikely. Therefore this study is considered for waiver. Repeated dose toxicity: dermal The acute toxicity value for substance 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely. Thus, it is expected that substance 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no dermal absorption data as well as no data available that suggests that substance 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/467e4b1e-e70c-4bd2-abc6-5953928da122/documents/63049996-5f02-45db-8f33-7e3cd42e710e_48b26c5e-7adb-4231-b861-ae5f041871f6.html,,,,,, "1-(2,4-dimethylphenylazo)-2-naphthol",3118-97-6,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/467e4b1e-e70c-4bd2-abc6-5953928da122/documents/63049996-5f02-45db-8f33-7e3cd42e710e_48b26c5e-7adb-4231-b861-ae5f041871f6.html,Chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "1-(2,4-dimethylphenylazo)-2-naphthol",3118-97-6," Acute toxicity: oral LD50 was estimated to be 2998 mg/kg bw when rats were orally exposed with 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol.  Acute toxicity: inhalation the study need not be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Acute toxicity: dermal Acute dermal LD50 value of the test substance 1-[(2,4-dimethylphenyl)diazenyl]-2-naphthol is estimated to be 2332.617 mg/kg bw to rats. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/467e4b1e-e70c-4bd2-abc6-5953928da122/documents/90cb4164-c167-435b-90c9-644bb323f702_48b26c5e-7adb-4231-b861-ae5f041871f6.html,,,,,, "1-(2,4-dimethylphenylazo)-2-naphthol",3118-97-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/467e4b1e-e70c-4bd2-abc6-5953928da122/documents/90cb4164-c167-435b-90c9-644bb323f702_48b26c5e-7adb-4231-b861-ae5f041871f6.html,,oral,LD50,"2,998 mg/kg bw",no adverse effect observed, "1-(2,4-dimethylphenylazo)-2-naphthol",3118-97-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/467e4b1e-e70c-4bd2-abc6-5953928da122/documents/90cb4164-c167-435b-90c9-644bb323f702_48b26c5e-7adb-4231-b861-ae5f041871f6.html,,dermal,LD50,"2,332.617 mg/kg bw",no adverse effect observed, "1,4-dioxane",123-91-1," Based on the weight of evidence of available sub-chronic and chronic repeated dose toxicity studies via the oral and the inhalation route in mice as well as in rats with 1,4 -dioxane, predominantly induction of tumors and pre-neoplastic lesions in the respiratory tract as well as in the liver. The lowest oral NOAEL was found to be 9.6 mg/kg bw/d in rats based on a chronic toxicity study (Kociba et al., 1974). Regarding inhalation route, the lowest LOAEC (local and systemic) was identified to be 180 mg/m3 (Kasai et al., 2009). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c1a2f2f-29f8-4cd6-83b2-7454d4ba058a/documents/IUC5-72532f95-2cf8-4e80-99f5-cc0a67ac5d91_c2988a88-b5dd-42c4-b709-24ef499c462d.html,,,,,, "1,4-dioxane",123-91-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c1a2f2f-29f8-4cd6-83b2-7454d4ba058a/documents/IUC5-72532f95-2cf8-4e80-99f5-cc0a67ac5d91_c2988a88-b5dd-42c4-b709-24ef499c462d.html,Chronic toxicity – systemic effects,oral,NOAEL,9.6 mg/kg bw/day,,rat "1,4-dioxane",123-91-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c1a2f2f-29f8-4cd6-83b2-7454d4ba058a/documents/IUC5-72532f95-2cf8-4e80-99f5-cc0a67ac5d91_c2988a88-b5dd-42c4-b709-24ef499c462d.html,Chronic toxicity – systemic effects,inhalation,LOAEC,180 mg/m3,,rat "1,4-dioxane",123-91-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c1a2f2f-29f8-4cd6-83b2-7454d4ba058a/documents/IUC5-72532f95-2cf8-4e80-99f5-cc0a67ac5d91_c2988a88-b5dd-42c4-b709-24ef499c462d.html,Repeated dose toxicity – local effects,inhalation,LOAEC,180 mg/m3,adverse effect observed,rat "1,4-dioxane",123-91-1," The acute oral and acute inhalation toxicity was investigated in studies performed comparable to the relevant OECD guidelines (401 and 403), resulting in an LD50 of approximately 5150 mg/kg bw, and an LC0 of 155 mg/L for 1 hour (which corresponds to 38.75 mg/L for 4 hours), respectively. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c1a2f2f-29f8-4cd6-83b2-7454d4ba058a/documents/IUC5-abe645cc-0c32-42f9-9e56-c099f1cd1153_c2988a88-b5dd-42c4-b709-24ef499c462d.html,,,,,, "1,4-dioxane",123-91-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c1a2f2f-29f8-4cd6-83b2-7454d4ba058a/documents/IUC5-abe645cc-0c32-42f9-9e56-c099f1cd1153_c2988a88-b5dd-42c4-b709-24ef499c462d.html,,oral,LD50,"5,150 mg/kg bw",adverse effect observed, "1,4-dioxane",123-91-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c1a2f2f-29f8-4cd6-83b2-7454d4ba058a/documents/IUC5-abe645cc-0c32-42f9-9e56-c099f1cd1153_c2988a88-b5dd-42c4-b709-24ef499c462d.html,,inhalation,discriminating conc.,"38,750 mg/m3",adverse effect observed, 1-bromopropane,106-94-5,"In accordance with Column 2 of REACH Annex VIII, the repeated dose toxicity study (required in Section 8.6.1) by the oral route does not need to be conducted as due to the physicochemical properties of the substance the most likely route of exposure is via inhalation.In accordance with Column 2 of REACH Annex VIII, the repeated dose toxicity study (required in Section 8.6.1) by the dermal route does not need to be conducted as neither significant skin contact is likely nor do the physicochemical properties (high vapour pressure of 14.772 kPa means rapid volatilisation before significant absorption can occur) suggest potential for a significant rate of absorption through the skin. Modelling and the high vapour pressure indicate that the most significant route of exposure is by the inhalation route.Nine studies are available for the repeat dose inhalation toxicity endpoint:Labbé. R (1997b) (28 day) - NOAEC (rat): <2 mg/L airAdamo-Trigiani. M (1997) (90 day) - NOEL (rat): 1 mg/L airLabbé. R (1997c) (10 day range finding study) - NOEC (rat): <15 mg/L airLabbé. R (1997d) (10 day range finding study) - NOEC (rat): 5 mg/L airMoon. Y.H. et al (1998) (8 week study) - NOAEC (rat): 300 ppmUSA National Institutes of Health (2011) (2 week range finding study) – NOAEC (rat): 250 ppm*USA National Institutes of Health (2011) (2 week range finding study) – NOAEC (mouse): 125 ppm*USA National Institutes of Health (2011) (3-month) – NOAEC (rat): 125 ppm (estimated at 0.64 mg/L**)USA National Institutes of Health (2011) (3 month) – NOAEC (mouse): 125 ppm (estimated at 0.64 mg/L**)*Notwithstanding limited histopathology**assuming 1 mole gas occupies 24.0056 L at RTP and MW = 122.9917 g/mole ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67ba37c7-530c-4721-a654-effeccb6b6b6/documents/0e9af8ec-7971-4112-a6e6-704e7e5bb203_95ac36da-8325-4833-8deb-dbb3d90fd457.html,,,,,, 1-bromopropane,106-94-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67ba37c7-530c-4721-a654-effeccb6b6b6/documents/0e9af8ec-7971-4112-a6e6-704e7e5bb203_95ac36da-8325-4833-8deb-dbb3d90fd457.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,640 mg/m3,,rat 1-bromopropane,106-94-5,Three studies are available for the acute oral toxicity endpoint:Clauzeau. J (1993) - LD50 (rat): >2000 mg/kg bwPaster. Z (1978a) - LD50 (rat): 4260 mg/kg bwPaster. Z (1978b) - LD50 (rabbit): 540 mg/kg bwThree studies are available for the acute inhalation toxicity endpoint:Schorsch. F (1997) - 4h-LC50 (rat): 35000 mg/m^3Moon. Y.H. et al (1998) - 4h-LC50 (rat): 14374 ppmLabbé. R (1997a) - 6h-LC50 (rat): between 25 and 35 mg/LTwo studies are available for the acute dermal toxicity endpoint:de Jouffrey. S (1995a) - LD50 (rat): >2000 mg/kg bwPaster. Z (1979) - LD50 (rabbit): >10 mL/kg bw ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67ba37c7-530c-4721-a654-effeccb6b6b6/documents/0da92fea-817d-4826-adb9-a208f0483f6f_95ac36da-8325-4833-8deb-dbb3d90fd457.html,,,,,, 1-bromopropane,106-94-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67ba37c7-530c-4721-a654-effeccb6b6b6/documents/0da92fea-817d-4826-adb9-a208f0483f6f_95ac36da-8325-4833-8deb-dbb3d90fd457.html,,oral,LD50,"2,000 mg/kg bw",, 1-bromopropane,106-94-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67ba37c7-530c-4721-a654-effeccb6b6b6/documents/0da92fea-817d-4826-adb9-a208f0483f6f_95ac36da-8325-4833-8deb-dbb3d90fd457.html,,dermal,LD50,"2,000 mg/kg bw",, 1-bromopropane,106-94-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67ba37c7-530c-4721-a654-effeccb6b6b6/documents/0da92fea-817d-4826-adb9-a208f0483f6f_95ac36da-8325-4833-8deb-dbb3d90fd457.html,,inhalation,LC50,"35,000 mg/m3",, "Hydrocarbons, C4, steam-cracker distillate",92045-23-3,"Members of the C4 low 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams in this category (CAS Numbers; 91052-98-1, 92045-23-3, 95465-89-7, 95465-90-0 and 95465-91-1) but data on the constituents (butane, isobutane and butene isomers) indicate that members of this category have low sub-chronic toxicity. Inhalation exposure is the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies in rats or mice for 6 weeks (butane and isobutane) or up to 2 years (butene isomers). Nasal lesions were observed in 2 year rodent studies on 2-methylpropene at the highest concentration and the NOAEC of 2000 ppm (4589 mg/m3) in rats is based on the lack of effect at this concentration. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/94210dd1-ed76-40b6-8a17-ef64ab874feb/documents/IUC5-c3aaa45f-6e5d-41d7-b934-e2001e4813c2_511d96b4-6505-44ee-a0ab-1a847dff796a.html,,,,,, "Hydrocarbons, C4, steam-cracker distillate",92045-23-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/94210dd1-ed76-40b6-8a17-ef64ab874feb/documents/IUC5-c3aaa45f-6e5d-41d7-b934-e2001e4813c2_511d96b4-6505-44ee-a0ab-1a847dff796a.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"18,359 mg/m3",,rat "Hydrocarbons, C4, steam-cracker distillate",92045-23-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/94210dd1-ed76-40b6-8a17-ef64ab874feb/documents/IUC5-c3aaa45f-6e5d-41d7-b934-e2001e4813c2_511d96b4-6505-44ee-a0ab-1a847dff796a.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"4,589 mg/m3",adverse effect observed,rat "Hydrocarbons, C4, steam-cracker distillate",92045-23-3,"Members of the C4 low 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams in this category (CAS Numbers; 91052-98-1, 92045-23-3, 95465-89-7, 95465-90-0 and 95465-91-1) but data on the constituents (butane, isobutane and butene isomers) indicate that the acute inhalational toxicity of this category is low. The LC50 values for all substances are in excess of 10,000 ppm (22,948 mg/m3) and butane and isobutane are considered to be Generally Recognised as Safe and may be used in food products. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94210dd1-ed76-40b6-8a17-ef64ab874feb/documents/IUC5-cd13b7cd-93e4-4e29-a758-cd0dc2e53f4b_511d96b4-6505-44ee-a0ab-1a847dff796a.html,,,,,, "Hydrocarbons, C4, steam-cracker distillate",92045-23-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94210dd1-ed76-40b6-8a17-ef64ab874feb/documents/IUC5-cd13b7cd-93e4-4e29-a758-cd0dc2e53f4b_511d96b4-6505-44ee-a0ab-1a847dff796a.html,,inhalation,LC50,"> 22,948 mg/m3",no adverse effect observed, "Alkanes, C4-5",68475-60-5,"Only one stream of the Other Petroleum Gases category has been tested but this and the main components of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. The mammalian toxicity effects of this category will be not driven by the content of benzene as the latter is present at levels of <0.3%, however, the category may contain carbon monoxide which could trigger classification. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8f42b29-310f-464a-848e-6be342da1054/documents/IUC5-5a55592f-8b72-4e82-bb98-63a06aaf7d45_5be4e81a-09af-4ca7-b395-cde89249690d.html,,,,,, "Alkanes, C4-5",68475-60-5,"Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the component substances. Across species, main component gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene as the latter is present at levels of <0.3%, however, the category may contain carbon monoxide and/or hydrogen sulphide which could trigger classification. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8f42b29-310f-464a-848e-6be342da1054/documents/IUC5-02176948-0c88-42d0-83b5-5edbdb9e65a5_5be4e81a-09af-4ca7-b395-cde89249690d.html,,,,,, "Distillates (petroleum), heavy thermal cracked",64741-81-7," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9f90396-972b-4ef3-b0f8-8d6d7e9af75d/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_59be3f49-bf5e-4f32-b263-a7dbb7f9ef8c.html,,,,,, "Distillates (petroleum), heavy thermal cracked",64741-81-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9f90396-972b-4ef3-b0f8-8d6d7e9af75d/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_59be3f49-bf5e-4f32-b263-a7dbb7f9ef8c.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Distillates (petroleum), heavy thermal cracked",64741-81-7,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9f90396-972b-4ef3-b0f8-8d6d7e9af75d/documents/12190120-6b6e-49c5-bed7-264eab246437_59be3f49-bf5e-4f32-b263-a7dbb7f9ef8c.html,,,,,, "Distillates (petroleum), heavy thermal cracked",64741-81-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9f90396-972b-4ef3-b0f8-8d6d7e9af75d/documents/12190120-6b6e-49c5-bed7-264eab246437_59be3f49-bf5e-4f32-b263-a7dbb7f9ef8c.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Distillates (petroleum), heavy thermal cracked",64741-81-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9f90396-972b-4ef3-b0f8-8d6d7e9af75d/documents/12190120-6b6e-49c5-bed7-264eab246437_59be3f49-bf5e-4f32-b263-a7dbb7f9ef8c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), heavy thermal cracked",64741-81-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9f90396-972b-4ef3-b0f8-8d6d7e9af75d/documents/12190120-6b6e-49c5-bed7-264eab246437_59be3f49-bf5e-4f32-b263-a7dbb7f9ef8c.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, Anthracene,120-12-7,No acute toxicity after oral and dermal application to experimental animals. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f013844-c6c1-4bde-95cb-743897b1a329/documents/IUC5-5541002a-199b-4588-b5e6-41461ec2c302_55079ad2-2f08-4afd-8931-bf4d2a6107e8.html,,,,,, "Distillates (petroleum), solvent-refined hydrotreated heavy, hydrogenated",94733-08-1,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1b454d1-9b97-4f62-a47c-9c3a028f770f/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_6c2b2262-f71e-4157-bc22-7b82d2467bba.html,,,,,, "Distillates (petroleum), solvent-refined hydrotreated heavy, hydrogenated",94733-08-1,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1b454d1-9b97-4f62-a47c-9c3a028f770f/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_6c2b2262-f71e-4157-bc22-7b82d2467bba.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Distillates (petroleum), solvent-refined hydrotreated heavy, hydrogenated",94733-08-1,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1b454d1-9b97-4f62-a47c-9c3a028f770f/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_6c2b2262-f71e-4157-bc22-7b82d2467bba.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Distillates (petroleum), solvent-refined hydrotreated heavy, hydrogenated",94733-08-1,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1b454d1-9b97-4f62-a47c-9c3a028f770f/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_6c2b2262-f71e-4157-bc22-7b82d2467bba.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Distillates (petroleum), solvent-refined hydrotreated heavy, hydrogenated",94733-08-1,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1b454d1-9b97-4f62-a47c-9c3a028f770f/documents/73761dae-46d6-428e-8e40-e5cc70088d96_6c2b2262-f71e-4157-bc22-7b82d2467bba.html,,,,,, "Distillates (petroleum), solvent-refined hydrotreated heavy, hydrogenated",94733-08-1,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1b454d1-9b97-4f62-a47c-9c3a028f770f/documents/73761dae-46d6-428e-8e40-e5cc70088d96_6c2b2262-f71e-4157-bc22-7b82d2467bba.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), solvent-refined hydrotreated heavy, hydrogenated",94733-08-1,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1b454d1-9b97-4f62-a47c-9c3a028f770f/documents/73761dae-46d6-428e-8e40-e5cc70088d96_6c2b2262-f71e-4157-bc22-7b82d2467bba.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), solvent-refined hydrotreated heavy, hydrogenated",94733-08-1,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1b454d1-9b97-4f62-a47c-9c3a028f770f/documents/73761dae-46d6-428e-8e40-e5cc70088d96_6c2b2262-f71e-4157-bc22-7b82d2467bba.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Residues, steam cracked, thermally treated",98219-64-8,"There are limited repeat dose toxicity data on any of the specific streams identified for this category. However, there are substantial data on the repeated dose toxicity of a number of specific components present in some streams i.e. benzene, toluene, ethylbenzene and styrene which demonstrate significant target organ toxicity. Classification will be required for streams that contain benzene or toluene at concentrations greater than or equal to 1%or 10% respectively. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9a92ca0-21a4-4b4e-ba5a-c87ca30099d4/documents/IUC5-2eacf0cb-ed53-4d6d-a900-c09c54ab0f7a_dca01e1e-c38a-4931-b255-49d6185111d9.html,,,,,, "Residues, steam cracked, thermally treated",98219-64-8,"Available data for 4 specific streams within this category [Carbon Black Oil (CAS 64742-90-1), E000014200 (CAS 68475-80-9), Rohnaphthalin-Gemisch (CAS 85117-10-8), Quenchoel (CAS 98072-36-7)], further information included in the Category Summary for Fuel Oils Category (ACC, 2005), and on specific components (benzene, toluene, ethylbenzene, styrene, naphthalene, biphenyl and anthracene) that are present in some streams indicate that acute toxicity is expected to be low. Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Therefore, classification will be required for streams containing a high proportion of naphthalene (≥25%) and styrene (>12.5%) but the highest concentration of ethylbenzene (10%) is too low to trigger classification. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (R67/H336) will be required for streams containing ≥20% toluene. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9a92ca0-21a4-4b4e-ba5a-c87ca30099d4/documents/IUC5-afc14175-f5f0-49c2-af24-494f70248dc4_dca01e1e-c38a-4931-b255-49d6185111d9.html,,,,,, "Naphtha (petroleum), light, C5-rich, sweetened",92045-60-8,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e01e125-c32a-4f8b-a0f4-95c2c7d040f7/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_d42d233e-dda2-4078-9d02-bcd513838a24.html,,,,,, "Naphtha (petroleum), light, C5-rich, sweetened",92045-60-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e01e125-c32a-4f8b-a0f4-95c2c7d040f7/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_d42d233e-dda2-4078-9d02-bcd513838a24.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), light, C5-rich, sweetened",92045-60-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e01e125-c32a-4f8b-a0f4-95c2c7d040f7/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_d42d233e-dda2-4078-9d02-bcd513838a24.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), light, C5-rich, sweetened",92045-60-8," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e01e125-c32a-4f8b-a0f4-95c2c7d040f7/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_d42d233e-dda2-4078-9d02-bcd513838a24.html,,,,,, "Naphtha (petroleum), light, C5-rich, sweetened",92045-60-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e01e125-c32a-4f8b-a0f4-95c2c7d040f7/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_d42d233e-dda2-4078-9d02-bcd513838a24.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light, C5-rich, sweetened",92045-60-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e01e125-c32a-4f8b-a0f4-95c2c7d040f7/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_d42d233e-dda2-4078-9d02-bcd513838a24.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light, C5-rich, sweetened",92045-60-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e01e125-c32a-4f8b-a0f4-95c2c7d040f7/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_d42d233e-dda2-4078-9d02-bcd513838a24.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, Carbon disulphide,75-15-0, see discussion below. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/95ce0bd2-f501-45eb-a0a3-dce7cc1c6fc5/documents/3ee679b5-cab8-42ce-a25f-0b8c807681b5_6be6f181-633e-4690-b60e-425f7beb0341.html,,,,,, Carbon disulphide,75-15-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/95ce0bd2-f501-45eb-a0a3-dce7cc1c6fc5/documents/3ee679b5-cab8-42ce-a25f-0b8c807681b5_6be6f181-633e-4690-b60e-425f7beb0341.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,253 mg/kg bw/day,,rat Carbon disulphide,75-15-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/95ce0bd2-f501-45eb-a0a3-dce7cc1c6fc5/documents/3ee679b5-cab8-42ce-a25f-0b8c807681b5_6be6f181-633e-4690-b60e-425f7beb0341.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,158 mg/m3,,rat Carbon disulphide,75-15-0, see discussion below ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95ce0bd2-f501-45eb-a0a3-dce7cc1c6fc5/documents/a363ac2b-556f-4488-a291-d17fa610abe5_6be6f181-633e-4690-b60e-425f7beb0341.html,,,,,, Carbon disulphide,75-15-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95ce0bd2-f501-45eb-a0a3-dce7cc1c6fc5/documents/a363ac2b-556f-4488-a291-d17fa610abe5_6be6f181-633e-4690-b60e-425f7beb0341.html,,inhalation,LC50,"10,350 mg/m3",adverse effect observed, "Residues (petroleum), hydrodesulfurized atmospheric tower",64742-78-5," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb570f74-9399-4efb-8ab3-62f247921c54/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_3a97dfd7-13a0-44cf-9c5c-243e4f31f662.html,,,,,, "Residues (petroleum), hydrodesulfurized atmospheric tower",64742-78-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb570f74-9399-4efb-8ab3-62f247921c54/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_3a97dfd7-13a0-44cf-9c5c-243e4f31f662.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Residues (petroleum), hydrodesulfurized atmospheric tower",64742-78-5,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb570f74-9399-4efb-8ab3-62f247921c54/documents/12190120-6b6e-49c5-bed7-264eab246437_3a97dfd7-13a0-44cf-9c5c-243e4f31f662.html,,,,,, "Residues (petroleum), hydrodesulfurized atmospheric tower",64742-78-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb570f74-9399-4efb-8ab3-62f247921c54/documents/12190120-6b6e-49c5-bed7-264eab246437_3a97dfd7-13a0-44cf-9c5c-243e4f31f662.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Residues (petroleum), hydrodesulfurized atmospheric tower",64742-78-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb570f74-9399-4efb-8ab3-62f247921c54/documents/12190120-6b6e-49c5-bed7-264eab246437_3a97dfd7-13a0-44cf-9c5c-243e4f31f662.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), hydrodesulfurized atmospheric tower",64742-78-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb570f74-9399-4efb-8ab3-62f247921c54/documents/12190120-6b6e-49c5-bed7-264eab246437_3a97dfd7-13a0-44cf-9c5c-243e4f31f662.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "Foots oil (petroleum), clay-treated",93924-32-4,"Based on 28-day read-across studies conducted using other lubricant base oils, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEL (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3.  The 90-day dermal studies gave a NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study that tested distillate aromatic extracts. Sufficiently refined foots oils (DMSO extract IP 346 < 3%) are not classified according to DSD for repeat-dose toxicity. Insufficiently refined foots oils (DMSO extract IP 346 ≥ 3%) are classified as carcinogenic. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/666734f5-b8a4-48b8-bd95-1f885c120f9d/documents/8d156d60-b896-4ddb-8382-002e588045bf_de1001ca-1d6c-4c63-ba20-b2bb9f4acbbe.html,,,,,, "Foots oil (petroleum), clay-treated",93924-32-4,"There is no acute toxicity data available for foots oils. However, read across data from other lubricant base oils is available and used for the foots oils category. Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc., 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Nine additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. The acute inhalation LC50 for other lubricant base oils is >5.0 mg/L. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/666734f5-b8a4-48b8-bd95-1f885c120f9d/documents/04fcfae1-5e75-4945-8cf6-75f76158c395_de1001ca-1d6c-4c63-ba20-b2bb9f4acbbe.html,,,,,, Acetonitrile,75-05-8, Reliable subchronic and chronic animal inhalation studies are available for acetonitrile.  Mice are more susceptible to acetonitrile toxicity than rats.  The subchronic and chronic inhalation NOAEC for acetonitrile in mice is 200 ppm (336 mg/m3) based on mortality. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f26c6a1-c36c-4757-97fb-8146fb289344/documents/IUC5-db1b66b6-5879-4c2e-967f-127bdb5d71be_44a2f079-ab48-4157-8890-a59548f494f7.html,,,,,, Acetonitrile,75-05-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f26c6a1-c36c-4757-97fb-8146fb289344/documents/IUC5-db1b66b6-5879-4c2e-967f-127bdb5d71be_44a2f079-ab48-4157-8890-a59548f494f7.html,Chronic toxicity – systemic effects,inhalation,NOAEC,336 mg/m3,,mouse Acetonitrile,75-05-8," There is a reliable acute oral LD50 value in mice, which are among the most sensitive species tested, of 617 mg/kg.  There is a reliable 4-hr inhalation LC50 value in mice of 6022 mg/m3.  Reliable studies show an acute 24-hour dermal LD50 value in rabbits of >2000 mg/kg. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f26c6a1-c36c-4757-97fb-8146fb289344/documents/IUC5-ab636e9e-f997-4174-8eb0-8d44a98a370a_44a2f079-ab48-4157-8890-a59548f494f7.html,,,,,, Acetonitrile,75-05-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f26c6a1-c36c-4757-97fb-8146fb289344/documents/IUC5-ab636e9e-f997-4174-8eb0-8d44a98a370a_44a2f079-ab48-4157-8890-a59548f494f7.html,,oral,LD50,617 mg/kg bw,adverse effect observed, Acetonitrile,75-05-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f26c6a1-c36c-4757-97fb-8146fb289344/documents/IUC5-ab636e9e-f997-4174-8eb0-8d44a98a370a_44a2f079-ab48-4157-8890-a59548f494f7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Acetonitrile,75-05-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f26c6a1-c36c-4757-97fb-8146fb289344/documents/IUC5-ab636e9e-f997-4174-8eb0-8d44a98a370a_44a2f079-ab48-4157-8890-a59548f494f7.html,,inhalation,LC50,"6,022 mg/m3",no adverse effect observed, "Hydrocarbons, C3",68606-26-8," Only one stream (Liquified Petroleum Gases CAS 68476 -85 -7) of the Other Petroleum Gases category has been tested but this and the main constituents of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and humans. The mammalian toxicity effects of this category will be driven by the content of benzene if the latter is present at levels of >10%. Additionally, the category may contain carbon monoxide which could trigger classification. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6551eec-037b-48c0-b46e-562f2255777d/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_7d3e612d-d9bc-4daf-9513-6b8f8f38d882.html,,,,,, "Hydrocarbons, C3",68606-26-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6551eec-037b-48c0-b46e-562f2255777d/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_7d3e612d-d9bc-4daf-9513-6b8f8f38d882.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"7,214 mg/m3",,rat "Hydrocarbons, C3",68606-26-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6551eec-037b-48c0-b46e-562f2255777d/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_7d3e612d-d9bc-4daf-9513-6b8f8f38d882.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"8,600 mg/m3",adverse effect observed,rat "Hydrocarbons, C3",68606-26-8," Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the constituents. Across species, main constituent gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene in streams where it is present at levels of <1%. However, some streams in this category may contain benzene levels >1% or carbon monoxide which could trigger classification. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6551eec-037b-48c0-b46e-562f2255777d/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_7d3e612d-d9bc-4daf-9513-6b8f8f38d882.html,,,,,, "Hydrocarbons, C3",68606-26-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6551eec-037b-48c0-b46e-562f2255777d/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_7d3e612d-d9bc-4daf-9513-6b8f8f38d882.html,,inhalation,LC50,"22,948 mg/m3",no adverse effect observed, "Residues (petroleum), hydrocracked",64741-75-9," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2d7b3d3-ba8a-4c13-a7cb-60c55f5c47c4/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_2c203d8f-5555-4a20-9a5f-4be3873b1323.html,,,,,, "Residues (petroleum), hydrocracked",64741-75-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2d7b3d3-ba8a-4c13-a7cb-60c55f5c47c4/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_2c203d8f-5555-4a20-9a5f-4be3873b1323.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Residues (petroleum), hydrocracked",64741-75-9,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2d7b3d3-ba8a-4c13-a7cb-60c55f5c47c4/documents/12190120-6b6e-49c5-bed7-264eab246437_2c203d8f-5555-4a20-9a5f-4be3873b1323.html,,,,,, "Residues (petroleum), hydrocracked",64741-75-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2d7b3d3-ba8a-4c13-a7cb-60c55f5c47c4/documents/12190120-6b6e-49c5-bed7-264eab246437_2c203d8f-5555-4a20-9a5f-4be3873b1323.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Residues (petroleum), hydrocracked",64741-75-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2d7b3d3-ba8a-4c13-a7cb-60c55f5c47c4/documents/12190120-6b6e-49c5-bed7-264eab246437_2c203d8f-5555-4a20-9a5f-4be3873b1323.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), hydrocracked",64741-75-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2d7b3d3-ba8a-4c13-a7cb-60c55f5c47c4/documents/12190120-6b6e-49c5-bed7-264eab246437_2c203d8f-5555-4a20-9a5f-4be3873b1323.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "1,2,3-trichloropropane",96-18-4,"- Repeated dose toxicity, oral: LOAEL = 8 mg/Kg bw for the rat, (OECD 408); study Hazelton (1983)- Repeated dose toxicity, dermal: no study available- Repeated dose toxicity, inhalation: NOAEC = 6 mg/m³ (= 1.0 ppm) for the rat, (OECD TG 413); study Monsanto (1983) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54b8617d-fe50-4b66-8d68-a61acb88a0f3/documents/IUC5-f21d4256-529d-4b46-b348-1d677bb30fd5_9f4a1d2a-2aea-492b-b6cf-a0bf6aa6a5c5.html,,,,,, "1,2,3-trichloropropane",96-18-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54b8617d-fe50-4b66-8d68-a61acb88a0f3/documents/IUC5-f21d4256-529d-4b46-b348-1d677bb30fd5_9f4a1d2a-2aea-492b-b6cf-a0bf6aa6a5c5.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,8 mg/kg bw/day,,rat "1,2,3-trichloropropane",96-18-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54b8617d-fe50-4b66-8d68-a61acb88a0f3/documents/IUC5-f21d4256-529d-4b46-b348-1d677bb30fd5_9f4a1d2a-2aea-492b-b6cf-a0bf6aa6a5c5.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,6 mg/m3,,rat "1,2,3-trichloropropane",96-18-4,- Oral: LD50: 120 mg/kg bw for the male rat (OECD TG 401); study Shell Development Company (1980a))- Dermal: LD50: 390 mg/Kg bw for the male rabbit (OECD TG 402); study Shell Development Company (1980b)- Inhalation: LC50(4 h): >= 4800 mg/kg bw for the rat (OECD TG 403); study Monsanto Company (1987) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54b8617d-fe50-4b66-8d68-a61acb88a0f3/documents/IUC5-e56b9298-5f64-4b6c-9c4c-f0a279624d0b_9f4a1d2a-2aea-492b-b6cf-a0bf6aa6a5c5.html,,,,,, "1,2,3-trichloropropane",96-18-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54b8617d-fe50-4b66-8d68-a61acb88a0f3/documents/IUC5-e56b9298-5f64-4b6c-9c4c-f0a279624d0b_9f4a1d2a-2aea-492b-b6cf-a0bf6aa6a5c5.html,,oral,LD50,120 mg/kg bw,adverse effect observed, "1,2,3-trichloropropane",96-18-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54b8617d-fe50-4b66-8d68-a61acb88a0f3/documents/IUC5-e56b9298-5f64-4b6c-9c4c-f0a279624d0b_9f4a1d2a-2aea-492b-b6cf-a0bf6aa6a5c5.html,,dermal,LD50,390 mg/kg bw,adverse effect observed, "1,2,3-trichloropropane",96-18-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54b8617d-fe50-4b66-8d68-a61acb88a0f3/documents/IUC5-e56b9298-5f64-4b6c-9c4c-f0a279624d0b_9f4a1d2a-2aea-492b-b6cf-a0bf6aa6a5c5.html,,inhalation,LC50,"4,800 mg/m3",adverse effect observed, "Lubricating oils (petroleum), base oils, paraffinic",93572-43-1,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/886de7d7-c31a-4117-972d-af0e6e4adc64/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_b4640c11-1f0a-434c-bfaa-249d465f569c.html,,,,,, "Lubricating oils (petroleum), base oils, paraffinic",93572-43-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/886de7d7-c31a-4117-972d-af0e6e4adc64/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_b4640c11-1f0a-434c-bfaa-249d465f569c.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Lubricating oils (petroleum), base oils, paraffinic",93572-43-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/886de7d7-c31a-4117-972d-af0e6e4adc64/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_b4640c11-1f0a-434c-bfaa-249d465f569c.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Lubricating oils (petroleum), base oils, paraffinic",93572-43-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/886de7d7-c31a-4117-972d-af0e6e4adc64/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_b4640c11-1f0a-434c-bfaa-249d465f569c.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Lubricating oils (petroleum), base oils, paraffinic",93572-43-1,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/886de7d7-c31a-4117-972d-af0e6e4adc64/documents/73761dae-46d6-428e-8e40-e5cc70088d96_b4640c11-1f0a-434c-bfaa-249d465f569c.html,,,,,, "Lubricating oils (petroleum), base oils, paraffinic",93572-43-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/886de7d7-c31a-4117-972d-af0e6e4adc64/documents/73761dae-46d6-428e-8e40-e5cc70088d96_b4640c11-1f0a-434c-bfaa-249d465f569c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Lubricating oils (petroleum), base oils, paraffinic",93572-43-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/886de7d7-c31a-4117-972d-af0e6e4adc64/documents/73761dae-46d6-428e-8e40-e5cc70088d96_b4640c11-1f0a-434c-bfaa-249d465f569c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Lubricating oils (petroleum), base oils, paraffinic",93572-43-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/886de7d7-c31a-4117-972d-af0e6e4adc64/documents/73761dae-46d6-428e-8e40-e5cc70088d96_b4640c11-1f0a-434c-bfaa-249d465f569c.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, o-anisidine,90-04-0,A NOAEL of 16 mg/ kg bw x d and a LOAEL of 80 mg/ kg bw x d were derived for systemic toxicity in a 28-days toxicity study with oral application. Major effects were toxicity of the hematological system. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4751662c-ab87-405c-b953-a5ff212f3aa8/documents/IUC5-634a7700-32a0-45d3-ba11-f7517b686b99_a6830432-2b69-4be2-b62f-53b38e85bb32.html,,,,,, o-anisidine,90-04-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4751662c-ab87-405c-b953-a5ff212f3aa8/documents/IUC5-634a7700-32a0-45d3-ba11-f7517b686b99_a6830432-2b69-4be2-b62f-53b38e85bb32.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,16 mg/kg bw/day,, o-anisidine,90-04-0,A LD50 value for acute oral toxicity was reported to be 1134 mg of submisssion substance per kg bw in male and female rats. An acute dermal LD50 was found to be > 2000 mg/kg bw in rats. As no mortality was observed when testing for acute inhalation toxicity using the highest technically feasible dose of 3870 mg/m³ the resulting LD50 was > 3870 mg/m³. After single exposure to o-Anisidin formation of relevant amounts of methaemoglobin was observed in a variety of species. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4751662c-ab87-405c-b953-a5ff212f3aa8/documents/IUC5-834d5a45-8743-4b3d-8594-19dcae724b64_a6830432-2b69-4be2-b62f-53b38e85bb32.html,,,,,, "Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrocracked distillate-based",94733-15-0,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9bdf68c-8d25-4a68-b22f-e5b1442e2d70/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_0eab44d7-885f-4729-b489-22c6965acabf.html,,,,,, "Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrocracked distillate-based",94733-15-0,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9bdf68c-8d25-4a68-b22f-e5b1442e2d70/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_0eab44d7-885f-4729-b489-22c6965acabf.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrocracked distillate-based",94733-15-0,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9bdf68c-8d25-4a68-b22f-e5b1442e2d70/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_0eab44d7-885f-4729-b489-22c6965acabf.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrocracked distillate-based",94733-15-0,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9bdf68c-8d25-4a68-b22f-e5b1442e2d70/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_0eab44d7-885f-4729-b489-22c6965acabf.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrocracked distillate-based",94733-15-0,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9bdf68c-8d25-4a68-b22f-e5b1442e2d70/documents/73761dae-46d6-428e-8e40-e5cc70088d96_0eab44d7-885f-4729-b489-22c6965acabf.html,,,,,, "Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrocracked distillate-based",94733-15-0,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9bdf68c-8d25-4a68-b22f-e5b1442e2d70/documents/73761dae-46d6-428e-8e40-e5cc70088d96_0eab44d7-885f-4729-b489-22c6965acabf.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrocracked distillate-based",94733-15-0,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9bdf68c-8d25-4a68-b22f-e5b1442e2d70/documents/73761dae-46d6-428e-8e40-e5cc70088d96_0eab44d7-885f-4729-b489-22c6965acabf.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Lubricating oils (petroleum), C18-40, solvent-dewaxed hydrocracked distillate-based",94733-15-0,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9bdf68c-8d25-4a68-b22f-e5b1442e2d70/documents/73761dae-46d6-428e-8e40-e5cc70088d96_0eab44d7-885f-4729-b489-22c6965acabf.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Diphenylamine,122-39-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): K2 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2883d8cc-8462-4310-a6e6-e7801c5cc993/documents/056496ec-17b4-4f6d-be8d-b9b01c8f13aa_704e91b4-50c9-4f89-8d87-726bcbc7ac92.html,,,,,, Diphenylamine,122-39-4," Two studies from the same authors (Lenz et al., 1990 and 1991), conducted with accepted scientific principles, were used for the evaluation of the oral acute toxicity. Lenz et al., 1990, the selected key study, evaluated the nephrotoxicity of DPA in male Syrian hamsters, male Sprague-Dawley rats, and male Mongolian gerbils, by administering doses of 400, 600 and 800 mg/Kg bw intraperitonally or orally. Lenz et al. 1991, the supporting study, assessed the renal papillotoxicity of diphenylamine dissolved in DMSO, investigated in male Surian hamsters, male Sprague-Dawley rats and female Mongolian gerbils. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2883d8cc-8462-4310-a6e6-e7801c5cc993/documents/IUC5-c78077a6-2806-4796-92d0-f028c5a15e97_704e91b4-50c9-4f89-8d87-726bcbc7ac92.html,,,,,, Diphenylamine,122-39-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2883d8cc-8462-4310-a6e6-e7801c5cc993/documents/IUC5-c78077a6-2806-4796-92d0-f028c5a15e97_704e91b4-50c9-4f89-8d87-726bcbc7ac92.html,,oral,LD50,800 mg/kg bw,adverse effect observed, "Fuel oil, no. 4",68476-31-3," No repeat-dose toxicity studies were located for oral toxicity of VGOs/HGOs/Distillate fuels. However, supporting information is available, with two studies conducted on petroleum substances in other categories; a sub-chronic study on a Kerosine (CAS 8008-20-6) and a chronic study on a Highly Refined Base Oil (CAS 8042-47-5). These do not contain significant amounts of the PAH constituents considered to be the drivers of toxicological hazard for VHGO, but have other constituents in common. They help to demonstrate that no significant toxicological hazard is expected from other aliphatic (paraffinic and naphthenic) and aromatic (mono- and di- aromatic) constituents.   In addition, one oral sub-chronic study is proposed on a VHGO substance containing high levels of PAH constituents.   For sub-chronic inhalation toxicity of VGOs/HGOs/Distillate fuels, a conservative sub-chronic NOAEC of 750 mg/m3 was determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of >1710 mg/m3 was established for systemic effects, based on no significant findings at this level (OECD 413).   In a subacute dermal repeated-dose toxicity test, the NOEL level based on dermal irritation was 0.0001 mL/kg and a NOEL of 0.5 mL/kg was calculated for systemic toxicity (OECD 410). For subchronic dermal toxicity, a NOAEL of 30 mg/kg body weight/day appears appropriate for VGOs/HGOs/Distillate fuels based on changes in haematological parameters (decreased RBC, haemoglobin, HCT), clinical chemistry values (increased urea nitrogen and cholesterol) parameters and organ weight effects (increased liver weight, decreased thymus weight). The NOAEL for local effects is 125 mg/kg body weight/d, based on histopathological changes present at the application site (OECD 411). In addition, a recent study to OECD 411 and GLP was conducted on a member of the VHGO category. This showed low systemic toxicity (NOAEL 600 mg/kg/day), with higher doses not possible due to excessive local irritation. This study was conducted on a substance in the category low in PAH content (the constituent expected to drive toxicological hazard). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce5bd72b-63b5-4ebe-a7b6-f6d34d1f1508/documents/6eb3217d-cfcb-4c55-a348-ca82d2c18ff0_4f0e4ac8-0d99-47c9-9460-44d18c9c05b4.html,,,,,, "Fuel oil, no. 4",68476-31-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce5bd72b-63b5-4ebe-a7b6-f6d34d1f1508/documents/6eb3217d-cfcb-4c55-a348-ca82d2c18ff0_4f0e4ac8-0d99-47c9-9460-44d18c9c05b4.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,30 mg/kg bw/day,,rat "Fuel oil, no. 4",68476-31-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce5bd72b-63b5-4ebe-a7b6-f6d34d1f1508/documents/6eb3217d-cfcb-4c55-a348-ca82d2c18ff0_4f0e4ac8-0d99-47c9-9460-44d18c9c05b4.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Fuel oil, no. 4",68476-31-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce5bd72b-63b5-4ebe-a7b6-f6d34d1f1508/documents/6eb3217d-cfcb-4c55-a348-ca82d2c18ff0_4f0e4ac8-0d99-47c9-9460-44d18c9c05b4.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Fuel oil, no. 4",68476-31-3," Acute Oral Toxicity: Acute oral toxicity of #2 home heating oil, was evaluated in male and female rats following a single oral gavage administration of the test material at different concentrations (similar to OECD 401).  The  LD50 for #2 home heating oil is 21.1 mL/kg body weight (approx 17,900 mg/kg). Based on all acute oral toxicity studies, the LD50 for VGOs/HGOs/Distillate fuels is > 5000 mg/kg bw. Acute Inhalation Toxicity: Acute inhalation toxicity of naval distillate in male and female rats was evaluated in a study involving whole-body exposure  for 4 hours (similar to OECD 403).  The acute inhalation LC50 was 4.1 mg/L . Acute Dermal Toxicity: In an acute dermal toxicity study, male and female New Zealand White rabbits were exposed to #2 home heating oil for 24 hours at a dose level of 5 mL/kg (approx 4300 mg/kg). The animals were then observed for 14 days (similar to OECD 402).  Based on this study, the acute dermal LD50 is > 4300 mg/kg.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce5bd72b-63b5-4ebe-a7b6-f6d34d1f1508/documents/50ca8717-e805-460b-bb99-b647882e2c88_4f0e4ac8-0d99-47c9-9460-44d18c9c05b4.html,,,,,, "Fuel oil, no. 4",68476-31-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce5bd72b-63b5-4ebe-a7b6-f6d34d1f1508/documents/50ca8717-e805-460b-bb99-b647882e2c88_4f0e4ac8-0d99-47c9-9460-44d18c9c05b4.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Fuel oil, no. 4",68476-31-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce5bd72b-63b5-4ebe-a7b6-f6d34d1f1508/documents/50ca8717-e805-460b-bb99-b647882e2c88_4f0e4ac8-0d99-47c9-9460-44d18c9c05b4.html,,dermal,LD50,"4,300 mg/kg bw",no adverse effect observed, "Fuel oil, no. 4",68476-31-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce5bd72b-63b5-4ebe-a7b6-f6d34d1f1508/documents/50ca8717-e805-460b-bb99-b647882e2c88_4f0e4ac8-0d99-47c9-9460-44d18c9c05b4.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, Biphenyl-2-ylamine,90-41-5,"Repeated Dose toxicity: Oral routeLOAEL was considered to be 3000 ppm (150 mg/kg/day) and NOAEL was 1000 ppm (50 mg/kg/day) when F344/ N male and female rat treated with 2-Biphenylamine.Repeated Dose toxicity: Inhalation routeThe chemical biphenyl-2-ylamine has low vapour pressure of 0.000117 mm Hg at 25 deg C as well as particle size that are larger than the inhalable particulates. In addiiton, the use fo the chemical does not indicate the likelyihood of epeated exposure by the inhalation route. Thus, this end point was considered for waiver since the chemical is not expected to exhibit adverse effects by the repeated inhaltion route of exposure. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3efbe305-57b8-4fed-8700-308ca54e700b/documents/IUC5-cb4ec1cb-f007-4ce3-8068-66e83d76a683_526fb9fc-99cd-4900-ab8a-75ce963a5908.html,,,,,, Biphenyl-2-ylamine,90-41-5,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3efbe305-57b8-4fed-8700-308ca54e700b/documents/IUC5-cb4ec1cb-f007-4ce3-8068-66e83d76a683_526fb9fc-99cd-4900-ab8a-75ce963a5908.html,Chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Biphenyl-2-ylamine,90-41-5,"Acute toxicity Oral:The acute oral median lethal dose (LD50) for the test compound 2 biphenylamine in male mice is found to be 1000 mg/kg whereas the LD100 for male and female mice is found to be 10000 mg/kg bw.Acute toxicity Inhalation:The chemical biphenyl-2-ylamine has a low vapour pressure of 0.000117 mmHg at 25°C. Also, the particle size distribution was found to be in the range of 106 micron to 150 micron and thus the particulates are not of the inhalable size. Thus exposure by the inhalation route to this chemcal seems highly unlikely. This end point was therefore considered for waiver.Acute toxicity Dermal:The median lethal dose (LD50) value of the test substance biphenyl-2-ylamine in rabbits was estimated to be 3328.752929688 mg/kg bw. Considering the CLP Criteria for classification of the substance, it is concluded that biphenyl-2-ylamine is not classified for acute Dermal toxicity to rabbits. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3efbe305-57b8-4fed-8700-308ca54e700b/documents/IUC5-a40a48d3-6bae-4cfa-8f6f-94a0b81b8f2b_526fb9fc-99cd-4900-ab8a-75ce963a5908.html,,,,,, Biphenyl-2-ylamine,90-41-5,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3efbe305-57b8-4fed-8700-308ca54e700b/documents/IUC5-a40a48d3-6bae-4cfa-8f6f-94a0b81b8f2b_526fb9fc-99cd-4900-ab8a-75ce963a5908.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, Biphenyl-2-ylamine,90-41-5,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3efbe305-57b8-4fed-8700-308ca54e700b/documents/IUC5-a40a48d3-6bae-4cfa-8f6f-94a0b81b8f2b_526fb9fc-99cd-4900-ab8a-75ce963a5908.html,,dermal,LD50,"3,328.753 mg/kg bw",no adverse effect observed, "Petrolatum (petroleum), hydrotreated",92045-77-7,"Data available on similar materials are sufficient to adequately characterize the repeated oral toxicity and the repeated dermal toxicity of insufficiently refined petrolatum and sufficiently refined petrolatum. The data are consistent in that they demonstrate minimal effects in rats and rabbits with the exception of minimal to moderate skin irritation following repeated dermal exposures and histopathological changes with questionable relevance to humans following repeated oral exposures. Potential exposures by inhalation are expected to be low due to the low vapour pressures of petrolatum. Accordingly, it does not seem likely that there is any potential for petrolatum to produce repeated dose toxicity by an inhalation route. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/011a438c-f53e-4f5f-a564-c6b922a23155/documents/41098277-a189-417c-b267-9953f928d6b5_f1c0895c-9b3d-4d77-87de-b08e2819ab6a.html,,,,,, "Petrolatum (petroleum), hydrotreated",92045-77-7,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/011a438c-f53e-4f5f-a564-c6b922a23155/documents/41098277-a189-417c-b267-9953f928d6b5_f1c0895c-9b3d-4d77-87de-b08e2819ab6a.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Petrolatum (petroleum), hydrotreated",92045-77-7,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/011a438c-f53e-4f5f-a564-c6b922a23155/documents/41098277-a189-417c-b267-9953f928d6b5_f1c0895c-9b3d-4d77-87de-b08e2819ab6a.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Petrolatum (petroleum), hydrotreated",92045-77-7,The acute toxicity of petrolatum (carcinogenic or unknown feed-stock and non-carcinogenic feed-stock) is low with no observed mortalities from oral or dermal applications. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/011a438c-f53e-4f5f-a564-c6b922a23155/documents/487cb143-84ad-42d7-9af4-e03f57e30851_f1c0895c-9b3d-4d77-87de-b08e2819ab6a.html,,,,,, "Petrolatum (petroleum), hydrotreated",92045-77-7,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/011a438c-f53e-4f5f-a564-c6b922a23155/documents/487cb143-84ad-42d7-9af4-e03f57e30851_f1c0895c-9b3d-4d77-87de-b08e2819ab6a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Petrolatum (petroleum), hydrotreated",92045-77-7,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/011a438c-f53e-4f5f-a564-c6b922a23155/documents/487cb143-84ad-42d7-9af4-e03f57e30851_f1c0895c-9b3d-4d77-87de-b08e2819ab6a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residual oils (petroleum), solvent deasphalted",64741-95-3,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58d493cc-22cc-480e-9732-266bf00e4f75/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_0a6b9fa4-7bf0-4e78-8e0b-f19605148d40.html,,,,,, "Residual oils (petroleum), solvent deasphalted",64741-95-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58d493cc-22cc-480e-9732-266bf00e4f75/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_0a6b9fa4-7bf0-4e78-8e0b-f19605148d40.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Residual oils (petroleum), solvent deasphalted",64741-95-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58d493cc-22cc-480e-9732-266bf00e4f75/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_0a6b9fa4-7bf0-4e78-8e0b-f19605148d40.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Residual oils (petroleum), solvent deasphalted",64741-95-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58d493cc-22cc-480e-9732-266bf00e4f75/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_0a6b9fa4-7bf0-4e78-8e0b-f19605148d40.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Residual oils (petroleum), solvent deasphalted",64741-95-3,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 =  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 =  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 = 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58d493cc-22cc-480e-9732-266bf00e4f75/documents/73761dae-46d6-428e-8e40-e5cc70088d96_0a6b9fa4-7bf0-4e78-8e0b-f19605148d40.html,,,,,, "Residual oils (petroleum), solvent deasphalted",64741-95-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58d493cc-22cc-480e-9732-266bf00e4f75/documents/73761dae-46d6-428e-8e40-e5cc70088d96_0a6b9fa4-7bf0-4e78-8e0b-f19605148d40.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Residual oils (petroleum), solvent deasphalted",64741-95-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58d493cc-22cc-480e-9732-266bf00e4f75/documents/73761dae-46d6-428e-8e40-e5cc70088d96_0a6b9fa4-7bf0-4e78-8e0b-f19605148d40.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residual oils (petroleum), solvent deasphalted",64741-95-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58d493cc-22cc-480e-9732-266bf00e4f75/documents/73761dae-46d6-428e-8e40-e5cc70088d96_0a6b9fa4-7bf0-4e78-8e0b-f19605148d40.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Fuels, diesel, no. 2",68476-34-6," There are seven oral sub-acute repeated dose oral studies conducted according to OECD TG 422. In sub-acute oral studies on CAS Numbers 64741-77-1, 68476-34-6, 68476-30-2 and 68334 -30 -5, there were no treatment-related adverse effects on systemic toxicity parameters up to and including the highest doses tested (1000 mg/kg/day for 68334 -30 -5 and 750 mg/kg/day for the remaining CAS numbers) and accordingly the NOAELs were set at these levels. In a sub-acute oral study on CAS 68476 -31 -3 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 750 mg/kg/day for males and 100 mg/kg/day for females.   In a sub-acute oral study on CAS 64741 -49 -7 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 750 mg/kg/day for males and 300 mg/kg/day for females. In a sub-acute oral study on CAS 68476 -31 -3 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 300 mg/kg/day for males and females. Supporting information is available, with two studies conducted on petroleum substances in other categories; a sub-chronic study on a Kerosine (CAS 8008-20-6) and a chronic study on a Highly Refined Base Oil (CAS 8042-47-5). These do not contain significant amounts of the PAH constituents considered to be the drivers of toxicological hazard for VHGO, but have other constituents in common. They help to demonstrate that no significant toxicological hazard is expected from other aliphatic (paraffinic and naphthenic) and aromatic (mono- and di- aromatic) constituents.   In addition, one oral sub-chronic study is proposed on a VHGO substance containing high levels of PAH constituents.   For sub-chronic inhalation toxicity of VGOs/HGOs/Distillate fuels, a conservative sub-chronic NOAEC of 750 mg/m3 was determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of >1710 mg/m3 was established for systemic effects, based on no significant findings at this level (OECD 413).   In a subacute dermal repeated-dose toxicity test, the NOEL level based on dermal irritation was 0.0001 mL/kg and a NOEL of 0.5 mL/kg was calculated for systemic toxicity (OECD 410). For subchronic dermal toxicity, a NOAEL of 30 mg/kg body weight/day appears appropriate for VGOs/HGOs/Distillate fuels based on changes in haematological parameters (decreased RBC, haemoglobin, HCT), clinical chemistry values (increased urea nitrogen and cholesterol) parameters and organ weight effects (increased liver weight, decreased thymus weight). The NOAEL for local effects is 125 mg/kg body weight/d, based on histopathological changes present at the application site (OECD 411). In addition, a recent study to OECD 411 and GLP was conducted on a member of the VHGO category. This showed low systemic toxicity (NOAEL 600 mg/kg/day), with higher doses not possible due to excessive local irritation. This study was conducted on a substance in the category low in PAH content (the constituent expected to drive toxicological hazard). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ab69d3f-bbd9-4546-9687-8e3892b72d48/documents/246ae508-16eb-446c-afd1-ad680080afdb_8c87ff76-7294-4716-8b46-495afaee48d6.html,,,,,, "Fuels, diesel, no. 2",68476-34-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ab69d3f-bbd9-4546-9687-8e3892b72d48/documents/246ae508-16eb-446c-afd1-ad680080afdb_8c87ff76-7294-4716-8b46-495afaee48d6.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,30 mg/kg bw/day,,rat "Fuels, diesel, no. 2",68476-34-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ab69d3f-bbd9-4546-9687-8e3892b72d48/documents/246ae508-16eb-446c-afd1-ad680080afdb_8c87ff76-7294-4716-8b46-495afaee48d6.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Fuels, diesel, no. 2",68476-34-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ab69d3f-bbd9-4546-9687-8e3892b72d48/documents/246ae508-16eb-446c-afd1-ad680080afdb_8c87ff76-7294-4716-8b46-495afaee48d6.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Fuels, diesel, no. 2",68476-34-6," Acute Oral Toxicity: Acute oral toxicity of #2 home heating oil, was evaluated in male and female rats following a single oral gavage administration of the test material at different concentrations (similar to OECD 401).  The  LD50 for #2 home heating oil is 21.1 mL/kg body weight (approx 17,900 mg/kg). Based on all acute oral toxicity studies, the LD50 for VGOs/HGOs/Distillate fuels is > 5000 mg/kg bw. Acute Inhalation Toxicity: Acute inhalation toxicity of naval distillate in male and female rats was evaluated in a study involving whole-body exposure  for 4 hours (similar to OECD 403).  The acute inhalation LC50 was 4.1 mg/L . Acute Dermal Toxicity: In an acute dermal toxicity study, male and female New Zealand White rabbits were exposed to #2 home heating oil for 24 hours at a dose level of 5 mL/kg (approx 4300 mg/kg). The animals were then observed for 14 days (similar to OECD 402).  Based on this study, the acute dermal LD50 is > 4300 mg/kg.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ab69d3f-bbd9-4546-9687-8e3892b72d48/documents/50ca8717-e805-460b-bb99-b647882e2c88_8c87ff76-7294-4716-8b46-495afaee48d6.html,,,,,, "Fuels, diesel, no. 2",68476-34-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ab69d3f-bbd9-4546-9687-8e3892b72d48/documents/50ca8717-e805-460b-bb99-b647882e2c88_8c87ff76-7294-4716-8b46-495afaee48d6.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Fuels, diesel, no. 2",68476-34-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ab69d3f-bbd9-4546-9687-8e3892b72d48/documents/50ca8717-e805-460b-bb99-b647882e2c88_8c87ff76-7294-4716-8b46-495afaee48d6.html,,dermal,LD50,"4,300 mg/kg bw",no adverse effect observed, "Fuels, diesel, no. 2",68476-34-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ab69d3f-bbd9-4546-9687-8e3892b72d48/documents/50ca8717-e805-460b-bb99-b647882e2c88_8c87ff76-7294-4716-8b46-495afaee48d6.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "Gases (petroleum), straight-run stabilizer off",68919-10-8," Only one stream (Liquified Petroleum Gases CAS 68476 -85 -7) of the Other Petroleum Gases category has been tested but this and the main components of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and humans. The mammalian toxicity effects of this category will be driven by the content of benzene if the latter is present at levels of >10%. Additionally, the category may contain carbon monoxide which could trigger classification. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/78ccace1-19f4-4f12-909d-11e838fa888a/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_7f87a253-10c0-4a9f-8c03-27e193a3621f.html,,,,,, "Gases (petroleum), straight-run stabilizer off",68919-10-8,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/78ccace1-19f4-4f12-909d-11e838fa888a/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_7f87a253-10c0-4a9f-8c03-27e193a3621f.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"7,214 mg/m3",,rat "Gases (petroleum), straight-run stabilizer off",68919-10-8,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/78ccace1-19f4-4f12-909d-11e838fa888a/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_7f87a253-10c0-4a9f-8c03-27e193a3621f.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"8,600 mg/m3",adverse effect observed,rat "Gases (petroleum), straight-run stabilizer off",68919-10-8," Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the component substances. Across species, main component gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene in streams where it is present at levels of <1%. However, some streams in this category may contain benzene levels >1% or carbon monoxide which could trigger classification. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78ccace1-19f4-4f12-909d-11e838fa888a/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_7f87a253-10c0-4a9f-8c03-27e193a3621f.html,,,,,, "Gases (petroleum), straight-run stabilizer off",68919-10-8,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78ccace1-19f4-4f12-909d-11e838fa888a/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_7f87a253-10c0-4a9f-8c03-27e193a3621f.html,,inhalation,LC50,"22,948 mg/m3",no adverse effect observed, "Distillates (petroleum), light vacuum",70592-77-7," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e42dc89-7061-4bc7-84cc-6fca7e4985ba/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_c2842cec-c637-4e6f-a581-6680d9648e5f.html,,,,,, "Distillates (petroleum), light vacuum",70592-77-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e42dc89-7061-4bc7-84cc-6fca7e4985ba/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_c2842cec-c637-4e6f-a581-6680d9648e5f.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Distillates (petroleum), light vacuum",70592-77-7,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e42dc89-7061-4bc7-84cc-6fca7e4985ba/documents/12190120-6b6e-49c5-bed7-264eab246437_c2842cec-c637-4e6f-a581-6680d9648e5f.html,,,,,, "Distillates (petroleum), light vacuum",70592-77-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e42dc89-7061-4bc7-84cc-6fca7e4985ba/documents/12190120-6b6e-49c5-bed7-264eab246437_c2842cec-c637-4e6f-a581-6680d9648e5f.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light vacuum",70592-77-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e42dc89-7061-4bc7-84cc-6fca7e4985ba/documents/12190120-6b6e-49c5-bed7-264eab246437_c2842cec-c637-4e6f-a581-6680d9648e5f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light vacuum",70592-77-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e42dc89-7061-4bc7-84cc-6fca7e4985ba/documents/12190120-6b6e-49c5-bed7-264eab246437_c2842cec-c637-4e6f-a581-6680d9648e5f.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity",72623-85-9,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/562de883-f6e8-4fc5-b903-20ee5e34f7bf/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_678e1155-8943-49b0-8351-d24d31d1c76d.html,,,,,, "Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity",72623-85-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/562de883-f6e8-4fc5-b903-20ee5e34f7bf/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_678e1155-8943-49b0-8351-d24d31d1c76d.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity",72623-85-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/562de883-f6e8-4fc5-b903-20ee5e34f7bf/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_678e1155-8943-49b0-8351-d24d31d1c76d.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity",72623-85-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/562de883-f6e8-4fc5-b903-20ee5e34f7bf/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_678e1155-8943-49b0-8351-d24d31d1c76d.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity",72623-85-9,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/562de883-f6e8-4fc5-b903-20ee5e34f7bf/documents/73761dae-46d6-428e-8e40-e5cc70088d96_678e1155-8943-49b0-8351-d24d31d1c76d.html,,,,,, "Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity",72623-85-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/562de883-f6e8-4fc5-b903-20ee5e34f7bf/documents/73761dae-46d6-428e-8e40-e5cc70088d96_678e1155-8943-49b0-8351-d24d31d1c76d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity",72623-85-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/562de883-f6e8-4fc5-b903-20ee5e34f7bf/documents/73761dae-46d6-428e-8e40-e5cc70088d96_678e1155-8943-49b0-8351-d24d31d1c76d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based, high-viscosity",72623-85-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/562de883-f6e8-4fc5-b903-20ee5e34f7bf/documents/73761dae-46d6-428e-8e40-e5cc70088d96_678e1155-8943-49b0-8351-d24d31d1c76d.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Disodium 3(or 5)-[[4-[(7-amino-1-hydroxy-3-sulphonato-2-naphthyl)azo]-1-naphthyl]azo]salicylate,34977-63-4," According to the acute oral toxicity study results the value of LD50 of the test substance, Direct Black 51, for female rats is higher than 2000 mg/kg of body weight. Acute toxicity studies via dermal or inhalation exposure are not available. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36876e83-4195-4b38-aa97-0b6daf17066e/documents/4096ed95-7d78-4c72-98c2-a911308e1a15_c3a2b3e6-249e-446d-b7f7-da4ff2ad9730.html,,,,,, Dibutyltin bis(2-ethylhexanoate),2781-10-4,"The following studies are available to address the repeat dose (oral) toxicity endpoint:Waalkens-Berendsen DH (2003) Dibutyldichlorostannane (CAS # 683-18-1): Reproduction/developmental toxicity screening test in rats, TNO, Project Organisation, Ecotoxicology, Utrechtseweg 48, P.O. Box 370, 3700 AJ Zeist, The Netherlands, Report No.: V 4906, Organotin Environmental Programme (ORTEP) Association, Stabilizer Task Force. Report Date.: 2003-12-04.Barnes, J. M. and Stoner, H. B. (1958). Toxic properties of some dialkyl and trialkyl tin salts. Brit. J. Industr. Med., 1958, 15, 15.Gaunt, I. F., Colley, J., Grasso, P., Creasy, M. and Gangolli, S. D. (1968). Acute and Short-term Toxicity Studies on Di-n-butyltin Dichloride in Rats. Fd Cosmet. Toxicol. Vol. 6, pp. 599-608. Pergamon Press 1968. Printed in Great Britain.Penninks A. H. & Seinen W. (1982). COMPARATIVE TOXICITY OF ALKYLTIN AND ESTERTIN STABILIZERS. Fd Chem. Toxic. Vol. 20. pp. 909 to 916.Dr. Salsbury's Laboratories (1961). Toxicity of Chemical Compounds, Rat Trial No. R-23a-61, Project No. 043. Testing laboratory: Dr. Salsbury's Laboratories. Report no.: R-23a-61. Owner company: ATOFINA Chemicals Inc.The Gaunt et al (1968) study has been allocated a Klimisch core of 2 on the basis that the study predates GLP; however, method was comparable to OECD Guideline 408. The effect of DBT exposure on the thymus of was not assessed in this study. The Penninks and Seinen (1982) study has also been allocated a Klimisch score of 2 on the basis that the study is a short-term feeding study with no information on the stability of the test substance in the diet or homogeneity of the test diets provided.The Barnes and Stoner (1958) study has been allocated a Klimisch score of 4.The Dr Salsubry's Laboratories study has been allocated a Klimisch score of 2 on the basis that the study predates GLP and because there is insufficient information on the test material. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc37b606-bcf1-477f-a57e-da0a065117c2/documents/IUC5-aad944a0-928a-416b-82e4-672eb4b58b34_f596b0f9-286e-4515-9d8d-9a5aa0392389.html,,,,,, Dibutyltin bis(2-ethylhexanoate),2781-10-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc37b606-bcf1-477f-a57e-da0a065117c2/documents/IUC5-aad944a0-928a-416b-82e4-672eb4b58b34_f596b0f9-286e-4515-9d8d-9a5aa0392389.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,0.3 mg/kg bw/day,, Dibutyltin bis(2-ethylhexanoate),2781-10-4,"Oral:The acute oral LD50 of TK 10708 in rats of both sexes observed over 14 days is 2071 mg/kg in a study conducted using a method which is considered similar to that in OECD Guideline 401. The test material is considered to be slightly toxic to the rat by this route of administration.Dermal:The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat observed over 14 days was determined to be greater than 2000 mg/kg bodyweight (in an GLP study conducted to OECD 402). Irritation was observed, and one female animal exhibited some symptoms of toxicity, however the test material did not meet the criteria for classification as acutely toxic via the dermal route.Inhalation:A waiver has been submitted to address the acute toxicity: inhalation endpoint on the basis of lack of exposure ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc37b606-bcf1-477f-a57e-da0a065117c2/documents/IUC5-b3be19e1-76c8-47fd-a2b7-ede2fd8665e4_f596b0f9-286e-4515-9d8d-9a5aa0392389.html,,,,,, Dibutyltin bis(2-ethylhexanoate),2781-10-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc37b606-bcf1-477f-a57e-da0a065117c2/documents/IUC5-b3be19e1-76c8-47fd-a2b7-ede2fd8665e4_f596b0f9-286e-4515-9d8d-9a5aa0392389.html,,oral,LD50,"2,071 mg/kg bw",no adverse effect observed, Dibutyltin bis(2-ethylhexanoate),2781-10-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc37b606-bcf1-477f-a57e-da0a065117c2/documents/IUC5-b3be19e1-76c8-47fd-a2b7-ede2fd8665e4_f596b0f9-286e-4515-9d8d-9a5aa0392389.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-ethylhexanoic acid,149-57-5,"In subchronic feeding studies, NOAEL's of approximately 200 and 300 mg/kg/day were established for mice and rats, respectively. Exposure to higher concentrations of 2-EHA was associated with growth retardation, increased liver weight and hepatocyte hypertrophy. In addition, in the highest dose groups decreased food consumption and body weights were observed. At the end of the recovery period (4 weeks), the observed changes had practically disappeared. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/397a4cca-ab3a-402b-b6f4-7514cf80bf0b/documents/IUC5-6608daf4-a0ef-44b7-aed4-55df86770935_c43be716-cf48-483d-8933-66a506a5eb90.html,,,,,, 2-ethylhexanoic acid,149-57-5,"2-EHA is practically non-toxic via the oral, dermal and inhalative route. The following values are taken into account for the risk assessment: LD50 (oral;rat): 3640 mg/kg bw; LD50 (dermal,rat) >2000 mg/kg bw; no acute toxicity from inhalative exposure to saturated vapor ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/397a4cca-ab3a-402b-b6f4-7514cf80bf0b/documents/IUC5-be8d91bd-05da-4f72-857b-063d64baa881_c43be716-cf48-483d-8933-66a506a5eb90.html,,,,,, Dimethyl sulphate,77-78-1,EU RISK ASSESSMENT – DIMETHYL SULPHATE ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ffea77e-f273-4449-9c26-8c690180698d/documents/IUC5-a4720ae1-a8a4-43f8-87f6-f9941473e4a7_c31724eb-d633-4b5f-8489-75205c45697a.html,,,,,, Dimethyl sulphate,77-78-1,EU RISK ASSESSMENT – DIMETHYL SULPHATE ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ffea77e-f273-4449-9c26-8c690180698d/documents/IUC5-c61a1c3e-38de-48f0-9420-6d1f7340e874_c31724eb-d633-4b5f-8489-75205c45697a.html,,,,,, Dimethyl sulphate,77-78-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ffea77e-f273-4449-9c26-8c690180698d/documents/IUC5-c61a1c3e-38de-48f0-9420-6d1f7340e874_c31724eb-d633-4b5f-8489-75205c45697a.html,,oral,LD50,106 mg/kg bw,, Dimethyl sulphate,77-78-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ffea77e-f273-4449-9c26-8c690180698d/documents/IUC5-c61a1c3e-38de-48f0-9420-6d1f7340e874_c31724eb-d633-4b5f-8489-75205c45697a.html,,inhalation,LC50,45 mg/m3,, "Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent",68783-04-0,"After subacute dermal exposure to UDAEs (equivalent to OECD 410), no signs of systemic toxicity were observed even at the high dose, 1000 mg/kg/day. After subchronic dermal exposure to UDAEs (equivalent to OECD 411), a NOAEL could not be established since toxicity was observed at all dosing levels, including the lowest dose tested. The authors considered the NOAEL for dermal exposure to be less than 30 mg/kg/day.  The NOAEL for oral exposure after subchronic exposure to a UDAE was less than 125 mg/kg (OECD 408).  After subacute inhalation exposure to Other Lubricant Base Oils (equivalent to OECD 412), the overall NOAEL for systemic effects was determined to be > 980 mg/m3.  Animals were exposed to OLBOs in subacute (OECD 410), subchronic (OECD 411), and chronic (OECD 453) dermal toxicity tests, and the resulting NOAELs based on systemic toxicity were > 1000 mg/kg bw/day, > 2000 mg/kg bw/day, and > 75 μL/week, respectively.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edfc41e5-9254-46c5-b9fe-60f911fc3aa0/documents/af7123af-d5f3-4267-be2d-ed3ffe193f10_5c228dc1-326c-4127-9020-5a55fc24314e.html,,,,,, "Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent",68783-04-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edfc41e5-9254-46c5-b9fe-60f911fc3aa0/documents/af7123af-d5f3-4267-be2d-ed3ffe193f10_5c228dc1-326c-4127-9020-5a55fc24314e.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent",68783-04-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edfc41e5-9254-46c5-b9fe-60f911fc3aa0/documents/af7123af-d5f3-4267-be2d-ed3ffe193f10_5c228dc1-326c-4127-9020-5a55fc24314e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent",68783-04-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edfc41e5-9254-46c5-b9fe-60f911fc3aa0/documents/af7123af-d5f3-4267-be2d-ed3ffe193f10_5c228dc1-326c-4127-9020-5a55fc24314e.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,30 mg/kg bw/day,,rat "Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent",68783-04-0,"Key read-across acute oral, dermal, and inhalation toxicity studies were identified from untreated distillate aromatic extracts and other lubricant base oils (OLBO; IP 346 < 3%)  Results for key studies are as follows:• The oral LD50 was > 5000 mg/kg bw in male and female rats for UDAEs in an acute oral study (similar to OECD 420).• The oral LD50 was > 5000 mg/kg bw in male and female rats for OLBO (IP 346 < 3%) in an acute oral study (OECD 401).• The dermal LD50 was > 2000 mg/kg/bw in male and female rabbits for UDAEs in an acute dermal study (similar to OECD 402).• The dermal LD50 was > 5000 mg/kg/bw in male and female rabbits for OLBO (IP 346 < 3%)  in an acute dermal study (OECD 402).• The inhalation LC50 was > 5 mg/L in male and female rats for UDAEs in an acute inhalation study (OECD 403).• The inhalation LC50 was > 5.53 mg/L in male and female rats for OLBO (IP 346 < 3%) in an acute inhalation study (OECD 403). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edfc41e5-9254-46c5-b9fe-60f911fc3aa0/documents/3e061494-9fe1-48e4-999d-f6eb70e388fd_5c228dc1-326c-4127-9020-5a55fc24314e.html,,,,,, "Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent",68783-04-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edfc41e5-9254-46c5-b9fe-60f911fc3aa0/documents/3e061494-9fe1-48e4-999d-f6eb70e388fd_5c228dc1-326c-4127-9020-5a55fc24314e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent",68783-04-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edfc41e5-9254-46c5-b9fe-60f911fc3aa0/documents/3e061494-9fe1-48e4-999d-f6eb70e388fd_5c228dc1-326c-4127-9020-5a55fc24314e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Extracts (petroleum), solvent-refined heavy paraffinic distillate solvent",68783-04-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edfc41e5-9254-46c5-b9fe-60f911fc3aa0/documents/3e061494-9fe1-48e4-999d-f6eb70e388fd_5c228dc1-326c-4127-9020-5a55fc24314e.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Prop-2-yn-1-ol,107-19-7,"The lowest NOAEL derived from repeated dose oral toxicity studies in rats (28-d and 90-d) was 5 mg/kg bw/d. A NOAEL (local and systemic) of 10-20 mg/kg bw/d (highest test dose) was derived from a subchronic dermal toxicity study in rabbits. From the results of repeated dose inhalation toxicity study in rats and mice a systemic NOAEC of 9.4 mg/m³ (4 ppm), a subchronic local NOAEC of 4 ppm and a chronic local LOAEC of 8 ppm was established. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/045ae176-bfa0-42fa-910a-411f0ab76957/documents/IUC5-d11c1861-c194-4708-be82-920f47d37c61_99d4a465-914d-46ce-9035-eeb8416448d0.html,,,,,, Prop-2-yn-1-ol,107-19-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/045ae176-bfa0-42fa-910a-411f0ab76957/documents/IUC5-d11c1861-c194-4708-be82-920f47d37c61_99d4a465-914d-46ce-9035-eeb8416448d0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat Prop-2-yn-1-ol,107-19-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/045ae176-bfa0-42fa-910a-411f0ab76957/documents/IUC5-d11c1861-c194-4708-be82-920f47d37c61_99d4a465-914d-46ce-9035-eeb8416448d0.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,20 mg/kg bw/day,,rabbit Prop-2-yn-1-ol,107-19-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/045ae176-bfa0-42fa-910a-411f0ab76957/documents/IUC5-d11c1861-c194-4708-be82-920f47d37c61_99d4a465-914d-46ce-9035-eeb8416448d0.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,9.4 mg/m3,,rat Prop-2-yn-1-ol,107-19-7,"The LD50/LC50 values derived form the key-studies were: LD50 (oral, rat) 56.4 mg/kg bw, LD50 (dermal, rabbit) 88 mg/kg bw, LC50 (2 h inhalation, rat) 2000 mg/m³. Based on these results, propargyl alcohol is considered to be toxic following acute oral, dermal or inhalation exposure. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/045ae176-bfa0-42fa-910a-411f0ab76957/documents/IUC5-52fbb80f-d7fe-43be-89fb-ea9bbc4672f8_99d4a465-914d-46ce-9035-eeb8416448d0.html,,,,,, Prop-2-yn-1-ol,107-19-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/045ae176-bfa0-42fa-910a-411f0ab76957/documents/IUC5-52fbb80f-d7fe-43be-89fb-ea9bbc4672f8_99d4a465-914d-46ce-9035-eeb8416448d0.html,,oral,LD50,56.4 mg/kg bw,, Prop-2-yn-1-ol,107-19-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/045ae176-bfa0-42fa-910a-411f0ab76957/documents/IUC5-52fbb80f-d7fe-43be-89fb-ea9bbc4672f8_99d4a465-914d-46ce-9035-eeb8416448d0.html,,dermal,LD50,88 mg/kg bw,, Prop-2-yn-1-ol,107-19-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/045ae176-bfa0-42fa-910a-411f0ab76957/documents/IUC5-52fbb80f-d7fe-43be-89fb-ea9bbc4672f8_99d4a465-914d-46ce-9035-eeb8416448d0.html,,inhalation,LC50,"2,000 mg/m3",, Diantimony trioxide,1309-64-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/95ae6450-b2df-47bf-92b0-b43a22fdc021/documents/c923fff4-ce5f-434a-9e62-bfe1ad0043b5_c46463ad-5199-4d55-adc6-ab90431a53b6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,686 mg/kg bw/day",,rat "Residues (petroleum), atm. tower",64741-45-3," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31e488f9-36a2-4d7c-adfa-d1808b0380be/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_22667096-d46d-4c78-9944-96dd9ff51cff.html,,,,,, "Residues (petroleum), atm. tower",64741-45-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31e488f9-36a2-4d7c-adfa-d1808b0380be/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_22667096-d46d-4c78-9944-96dd9ff51cff.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Residues (petroleum), atm. tower",64741-45-3,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31e488f9-36a2-4d7c-adfa-d1808b0380be/documents/12190120-6b6e-49c5-bed7-264eab246437_22667096-d46d-4c78-9944-96dd9ff51cff.html,,,,,, "Residues (petroleum), atm. tower",64741-45-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31e488f9-36a2-4d7c-adfa-d1808b0380be/documents/12190120-6b6e-49c5-bed7-264eab246437_22667096-d46d-4c78-9944-96dd9ff51cff.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Residues (petroleum), atm. tower",64741-45-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31e488f9-36a2-4d7c-adfa-d1808b0380be/documents/12190120-6b6e-49c5-bed7-264eab246437_22667096-d46d-4c78-9944-96dd9ff51cff.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), atm. tower",64741-45-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31e488f9-36a2-4d7c-adfa-d1808b0380be/documents/12190120-6b6e-49c5-bed7-264eab246437_22667096-d46d-4c78-9944-96dd9ff51cff.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, Tributyl phosphate,126-73-8,"For tributyl phosphate many studies on rats, mice and rabbity are available. The most valid 28 day and 90 day studies in mice and a 2-year study in rats are taken into consideration for assessment. The lowest NOEL of these studies (8.9 mg/kg bw/day), obtained in the 2-year rat study, is taken forward for DNEL derivation. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fad031e-69c8-4302-ba8e-079537b69994/documents/IUC5-15b62dc2-8d4e-45ae-99f7-f32269b1e677_fe2c4c3b-053d-4445-a641-03a21b64cb1e.html,,,,,, Tributyl phosphate,126-73-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fad031e-69c8-4302-ba8e-079537b69994/documents/IUC5-15b62dc2-8d4e-45ae-99f7-f32269b1e677_fe2c4c3b-053d-4445-a641-03a21b64cb1e.html,Chronic toxicity – systemic effects,oral,NOAEL,8.9 mg/kg bw/day,,rat Tributyl phosphate,126-73-8,"Several acute toxicity studies were performed with tributyl phosphate. Here only the reliable studies are reported: In the key study for acute oral toxicity an LD50 of 1553 mg/kg bw was found in rats. This value was supported by another study in rats were an LD50 of 1400 mg/kg bw was determined.In the key study for acute dermal toxicity an LD50 > 3100 mg/kg bw (highest applied dose) was observed in rats.Acute inhalation toxicity was determined with tributyl phosphate in male and female Wistar rats (key-study). The doses tested for 4 hours were 0, 511, 801, 2140 mg/m³, and the highest technically achievable concentration of 4242 mg/m³ air. At 4242 mg/m³ air 2 of 5 male rats died, whereas the female rats in this dose group showed no mortalities. Acute inhalation exposure to tributyl phosphate exerted clinical signs that were indicative of distinct irritation to the respiratory tract. The LD 50 was approx. 4242 mg/m³ air in the more sensitive male rat. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fad031e-69c8-4302-ba8e-079537b69994/documents/IUC5-7494fffc-ee8f-4f50-8955-d3a9d041a359_fe2c4c3b-053d-4445-a641-03a21b64cb1e.html,,,,,, Tributyl phosphate,126-73-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fad031e-69c8-4302-ba8e-079537b69994/documents/IUC5-7494fffc-ee8f-4f50-8955-d3a9d041a359_fe2c4c3b-053d-4445-a641-03a21b64cb1e.html,,oral,LD50,"1,553 mg/kg bw",adverse effect observed, Tributyl phosphate,126-73-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fad031e-69c8-4302-ba8e-079537b69994/documents/IUC5-7494fffc-ee8f-4f50-8955-d3a9d041a359_fe2c4c3b-053d-4445-a641-03a21b64cb1e.html,,dermal,LD50,"3,100 mg/kg bw",no adverse effect observed, Tributyl phosphate,126-73-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fad031e-69c8-4302-ba8e-079537b69994/documents/IUC5-7494fffc-ee8f-4f50-8955-d3a9d041a359_fe2c4c3b-053d-4445-a641-03a21b64cb1e.html,,inhalation,LC50,"4,242 mg/m3",adverse effect observed, Hydrogen cyanide,74-90-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41fd85be-1f2b-4e96-9262-84dd317e0597/documents/04b9d425-1ac9-4360-9a54-f8cedde40a58_4719701d-e6e6-4780-b549-116a6740a226.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,10 mg/m3,, Hydrogen cyanide,74-90-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41fd85be-1f2b-4e96-9262-84dd317e0597/documents/04b9d425-1ac9-4360-9a54-f8cedde40a58_4719701d-e6e6-4780-b549-116a6740a226.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,13 mg/kg bw/day,,rat Hydrogen cyanide,74-90-8,"LC50 and LC01 values have been estimated for human exposure, based on the duration of time during which inhalation occurs. These values are derived from acute studies in large animals. LC50 values range from 676 mg/m3 for 5 minutes, to 73 mg/m3 for 480 minutes. LC01 values range from 296 mg/m3 for 5 minutes, to 32 mg/m3 for 480 minutes. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41fd85be-1f2b-4e96-9262-84dd317e0597/documents/6f094b32-0c37-4ebb-9d14-fff0803a3d42_4719701d-e6e6-4780-b549-116a6740a226.html,,,,,, Hydrogen cyanide,74-90-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41fd85be-1f2b-4e96-9262-84dd317e0597/documents/6f094b32-0c37-4ebb-9d14-fff0803a3d42_4719701d-e6e6-4780-b549-116a6740a226.html,,oral,LD50,3.62 mg/kg bw,adverse effect observed, Hydrogen cyanide,74-90-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41fd85be-1f2b-4e96-9262-84dd317e0597/documents/6f094b32-0c37-4ebb-9d14-fff0803a3d42_4719701d-e6e6-4780-b549-116a6740a226.html,,dermal,LD50,2.34 mg/kg bw,adverse effect observed, Hydrogen cyanide,74-90-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41fd85be-1f2b-4e96-9262-84dd317e0597/documents/6f094b32-0c37-4ebb-9d14-fff0803a3d42_4719701d-e6e6-4780-b549-116a6740a226.html,,inhalation,LC50,103 mg/m3,adverse effect observed, Fuel gases,68476-26-6,"Only one stream (Liquified Petroleum Gases CAS 68476 -85 -7) of the Other Petroleum Gases category has been tested but this and the main constituents of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and humans. The mammalian toxicity effects of this category will be driven by the content of benzene if the latter is present at levels of >10%. Additionally, the category may contain carbon monoxide which could trigger classification.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2ae9aa7-9f1f-4e8a-b1f0-95d2e95553c8/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_35044ec1-3211-4a14-a070-aa600cd4a468.html,,,,,, Fuel gases,68476-26-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2ae9aa7-9f1f-4e8a-b1f0-95d2e95553c8/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_35044ec1-3211-4a14-a070-aa600cd4a468.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"7,214 mg/m3",,rat Fuel gases,68476-26-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2ae9aa7-9f1f-4e8a-b1f0-95d2e95553c8/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_35044ec1-3211-4a14-a070-aa600cd4a468.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"8,600 mg/m3",adverse effect observed,rat Fuel gases,68476-26-6,"Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the constituents. Across species, main constituent gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene in streams where it is present at levels of <1%. However, some streams in this category may contain benzene levels >1% or carbon monoxide which could trigger classification. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2ae9aa7-9f1f-4e8a-b1f0-95d2e95553c8/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_35044ec1-3211-4a14-a070-aa600cd4a468.html,,,,,, Fuel gases,68476-26-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2ae9aa7-9f1f-4e8a-b1f0-95d2e95553c8/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_35044ec1-3211-4a14-a070-aa600cd4a468.html,,inhalation,LC50,"22,948 mg/m3",no adverse effect observed, Amitrole,61-82-5,"Repeated dose toxicity: oral: LOAEL (female) =< 12 mg/kg bw/day, LOAEL (male) =< 1.5 mg/kg bw/day (similar to OECD 408, GLP, rel.2, K)   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8bf81f8-84e4-4fdf-baf1-df09dad6d4c3/documents/60c3a7c7-35cf-4d80-919c-13fc8bac8e9e_4b6e1cd4-cf74-45c1-b179-7ad2eee0f35e.html,,,,,, Amitrole,61-82-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8bf81f8-84e4-4fdf-baf1-df09dad6d4c3/documents/60c3a7c7-35cf-4d80-919c-13fc8bac8e9e_4b6e1cd4-cf74-45c1-b179-7ad2eee0f35e.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,1.5 mg/kg bw/day,,rat Amitrole,61-82-5,"Acute toxicity: oral: LD50 > 10000 mg/kg bw (OECD 401, GLP, rel.1, K) Acute toxicity: dermal: LD50 > 2000 mg/kg bw (OECD 402, GLP, rel.2, K) Acute toxicity: inhalation: waiving   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8bf81f8-84e4-4fdf-baf1-df09dad6d4c3/documents/008334ad-c6c7-4f1e-8021-eb10afdfba74_4b6e1cd4-cf74-45c1-b179-7ad2eee0f35e.html,,,,,, Amitrole,61-82-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8bf81f8-84e4-4fdf-baf1-df09dad6d4c3/documents/008334ad-c6c7-4f1e-8021-eb10afdfba74_4b6e1cd4-cf74-45c1-b179-7ad2eee0f35e.html,,oral,LD50,">=10,000 mg/kg bw",no adverse effect observed, Amitrole,61-82-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8bf81f8-84e4-4fdf-baf1-df09dad6d4c3/documents/008334ad-c6c7-4f1e-8021-eb10afdfba74_4b6e1cd4-cf74-45c1-b179-7ad2eee0f35e.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Petroleum products, hydrofiner-powerformer reformates",68514-79-4,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/666eed9e-0f76-4b78-83ca-78b1e7366882/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_2ddf5666-e3cc-4e86-b00d-b3159c7b2f35.html,,,,,, "Petroleum products, hydrofiner-powerformer reformates",68514-79-4,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/666eed9e-0f76-4b78-83ca-78b1e7366882/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_2ddf5666-e3cc-4e86-b00d-b3159c7b2f35.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Petroleum products, hydrofiner-powerformer reformates",68514-79-4,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/666eed9e-0f76-4b78-83ca-78b1e7366882/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_2ddf5666-e3cc-4e86-b00d-b3159c7b2f35.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Petroleum products, hydrofiner-powerformer reformates",68514-79-4,"The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401)Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions)Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/666eed9e-0f76-4b78-83ca-78b1e7366882/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_2ddf5666-e3cc-4e86-b00d-b3159c7b2f35.html,,,,,, "Petroleum products, hydrofiner-powerformer reformates",68514-79-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/666eed9e-0f76-4b78-83ca-78b1e7366882/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_2ddf5666-e3cc-4e86-b00d-b3159c7b2f35.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Petroleum products, hydrofiner-powerformer reformates",68514-79-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/666eed9e-0f76-4b78-83ca-78b1e7366882/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_2ddf5666-e3cc-4e86-b00d-b3159c7b2f35.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Petroleum products, hydrofiner-powerformer reformates",68514-79-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/666eed9e-0f76-4b78-83ca-78b1e7366882/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_2ddf5666-e3cc-4e86-b00d-b3159c7b2f35.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha (petroleum), light thermal cracked",64741-74-8,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47cce478-72db-439d-959b-222f370f424d/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_d17a4eeb-6846-48ed-b75c-9601fb918262.html,,,,,, "Naphtha (petroleum), light thermal cracked",64741-74-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47cce478-72db-439d-959b-222f370f424d/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_d17a4eeb-6846-48ed-b75c-9601fb918262.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), light thermal cracked",64741-74-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47cce478-72db-439d-959b-222f370f424d/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_d17a4eeb-6846-48ed-b75c-9601fb918262.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), light thermal cracked",64741-74-8," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47cce478-72db-439d-959b-222f370f424d/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_d17a4eeb-6846-48ed-b75c-9601fb918262.html,,,,,, "Naphtha (petroleum), light thermal cracked",64741-74-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47cce478-72db-439d-959b-222f370f424d/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_d17a4eeb-6846-48ed-b75c-9601fb918262.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light thermal cracked",64741-74-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47cce478-72db-439d-959b-222f370f424d/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_d17a4eeb-6846-48ed-b75c-9601fb918262.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light thermal cracked",64741-74-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47cce478-72db-439d-959b-222f370f424d/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_d17a4eeb-6846-48ed-b75c-9601fb918262.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, Sodium azide,26628-22-8,"Sodium azide was tested in a 2-year carcinogenicity study conducted by the NTP (1991). In this study, adverse effects were found after oral administration by gavage of sodium azide in male and female rats. Based on the brain necrosis, mortality which was attributed to brain necrosis, other pathological findings, body weight, food consumption and clinical and behavioral signs, a NOAEL of 5 mg/kg bw was determined. Equivocal results were observed in the 90-day oral study. In this study, a NOAEL of 10 mg/bw was determined based on mortality which is attributed to the observed brain necrosis, clinical and behavioral signs as well as other histopathological findings (pulmonary congestion and haemorrhage). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Study conducted equivalent to guideline ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b2d0625-8817-4e6a-aab8-8ba495e1a969/documents/b41cc765-e820-4859-a399-bb32e22ff5c2_e3daafb4-ca24-46ad-b1f9-a8015f7c1a18.html,,,,,, Sodium azide,26628-22-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b2d0625-8817-4e6a-aab8-8ba495e1a969/documents/b41cc765-e820-4859-a399-bb32e22ff5c2_e3daafb4-ca24-46ad-b1f9-a8015f7c1a18.html,Chronic toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat Sodium azide,26628-22-8,"The acute oral toxicity of sodium azide was evaluated in five acute oral toxicity studies available in the public literature. Based on the results and following a weight-of-evidence approach, the LD50 value of 27 mg/kg bw was chosen as the key parameter. Therefore, the classification of sodium azide as acute Tox.2, H300 in accordance with Annex VI of the CLP Regulation 1272/2008 is warranted. In an acute inhalation toxicity study conducted according to EPA OPPTS 870.1300, the LC50 for acute inhalation toxicity ranged from 0.054 to 0.52 mg/L in male and female rats. Therefore, the classification of sodium azide as Acute Tox.2, H330 according to CLP Regulation 1272/2008 is warranted. Furthermore, the acute dermal toxicity of sodium azide was evaluated in four acute dermal toxicity studies available in the public literature. Based on the results and following a weight-of-evidence approach, the LD50 value of 18 mg/kg bw was chosen as the key parameter. Therefore, the classification of sodium azide as Acute Tox.1, H310, according to CLP Regulation 1272/2008, is warranted. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Weight of evidence Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Guideline study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Weight of evidence ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b2d0625-8817-4e6a-aab8-8ba495e1a969/documents/IUC5-d40b1586-7748-4418-9534-8a70da92b4dc_e3daafb4-ca24-46ad-b1f9-a8015f7c1a18.html,,,,,, Sodium azide,26628-22-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b2d0625-8817-4e6a-aab8-8ba495e1a969/documents/IUC5-d40b1586-7748-4418-9534-8a70da92b4dc_e3daafb4-ca24-46ad-b1f9-a8015f7c1a18.html,,oral,LD50,27 mg/kg bw,adverse effect observed, Sodium azide,26628-22-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b2d0625-8817-4e6a-aab8-8ba495e1a969/documents/IUC5-d40b1586-7748-4418-9534-8a70da92b4dc_e3daafb4-ca24-46ad-b1f9-a8015f7c1a18.html,,dermal,LD50,18 mg/kg bw,adverse effect observed, Sodium azide,26628-22-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b2d0625-8817-4e6a-aab8-8ba495e1a969/documents/IUC5-d40b1586-7748-4418-9534-8a70da92b4dc_e3daafb4-ca24-46ad-b1f9-a8015f7c1a18.html,,inhalation,LC50,> 0.054 mg/L,adverse effect observed, "Hydrocarbons, C4-11, naphtha-cracking, arom.-free",92045-63-1,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f560d05-b1dd-47cd-a7cc-0ba88867d9cd/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_10a1c657-b145-48c4-b5cd-8fbe36c34bbd.html,,,,,, "Hydrocarbons, C4-11, naphtha-cracking, arom.-free",92045-63-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f560d05-b1dd-47cd-a7cc-0ba88867d9cd/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_10a1c657-b145-48c4-b5cd-8fbe36c34bbd.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Hydrocarbons, C4-11, naphtha-cracking, arom.-free",92045-63-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f560d05-b1dd-47cd-a7cc-0ba88867d9cd/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_10a1c657-b145-48c4-b5cd-8fbe36c34bbd.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Hydrocarbons, C4-11, naphtha-cracking, arom.-free",92045-63-1," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f560d05-b1dd-47cd-a7cc-0ba88867d9cd/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_10a1c657-b145-48c4-b5cd-8fbe36c34bbd.html,,,,,, "Hydrocarbons, C4-11, naphtha-cracking, arom.-free",92045-63-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f560d05-b1dd-47cd-a7cc-0ba88867d9cd/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_10a1c657-b145-48c4-b5cd-8fbe36c34bbd.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C4-11, naphtha-cracking, arom.-free",92045-63-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f560d05-b1dd-47cd-a7cc-0ba88867d9cd/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_10a1c657-b145-48c4-b5cd-8fbe36c34bbd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C4-11, naphtha-cracking, arom.-free",92045-63-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f560d05-b1dd-47cd-a7cc-0ba88867d9cd/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_10a1c657-b145-48c4-b5cd-8fbe36c34bbd.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha (petroleum), sweetened",64741-87-3,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/87fb2858-ee20-4a3a-a24a-967e255c126f/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_442d33ae-c5a5-489c-b7bf-987a42c1198e.html,,,,,, "Naphtha (petroleum), sweetened",64741-87-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/87fb2858-ee20-4a3a-a24a-967e255c126f/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_442d33ae-c5a5-489c-b7bf-987a42c1198e.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), sweetened",64741-87-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/87fb2858-ee20-4a3a-a24a-967e255c126f/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_442d33ae-c5a5-489c-b7bf-987a42c1198e.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), sweetened",64741-87-3," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87fb2858-ee20-4a3a-a24a-967e255c126f/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_442d33ae-c5a5-489c-b7bf-987a42c1198e.html,,,,,, "Naphtha (petroleum), sweetened",64741-87-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87fb2858-ee20-4a3a-a24a-967e255c126f/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_442d33ae-c5a5-489c-b7bf-987a42c1198e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), sweetened",64741-87-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87fb2858-ee20-4a3a-a24a-967e255c126f/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_442d33ae-c5a5-489c-b7bf-987a42c1198e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), sweetened",64741-87-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87fb2858-ee20-4a3a-a24a-967e255c126f/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_442d33ae-c5a5-489c-b7bf-987a42c1198e.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, Methylprednisolone,83-43-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f658f146-45c2-42ae-8014-9762b272646f/documents/IUC5-2d37a7b4-5741-49dc-ace7-4822b9965dbd_3d3c7fd6-3e17-4c92-9742-8a42598ff28f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Prednisolone,50-24-8,The acute oral LD50 values of prednisolone is higher than 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37fa3e0e-00a6-4bbb-bb06-a3199770b89a/documents/IUC5-ebcafc59-ab14-473a-b270-4bab685a0fb4_c23633d9-131d-4182-aa83-a088555d2c87.html,,,,,, Prednisolone,50-24-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37fa3e0e-00a6-4bbb-bb06-a3199770b89a/documents/IUC5-ebcafc59-ab14-473a-b270-4bab685a0fb4_c23633d9-131d-4182-aa83-a088555d2c87.html,,oral,LD50,"3,857 mg/kg bw",, "Naphtha (petroleum), heavy hydrocracked",64741-78-2,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5b79eaa-3527-4ddc-a083-1021a3333a48/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_1969207c-fafc-47df-90f6-a4c390272d7d.html,,,,,, "Naphtha (petroleum), heavy hydrocracked",64741-78-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5b79eaa-3527-4ddc-a083-1021a3333a48/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_1969207c-fafc-47df-90f6-a4c390272d7d.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), heavy hydrocracked",64741-78-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5b79eaa-3527-4ddc-a083-1021a3333a48/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_1969207c-fafc-47df-90f6-a4c390272d7d.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), heavy hydrocracked",64741-78-2," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5b79eaa-3527-4ddc-a083-1021a3333a48/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_1969207c-fafc-47df-90f6-a4c390272d7d.html,,,,,, "Naphtha (petroleum), heavy hydrocracked",64741-78-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5b79eaa-3527-4ddc-a083-1021a3333a48/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_1969207c-fafc-47df-90f6-a4c390272d7d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), heavy hydrocracked",64741-78-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5b79eaa-3527-4ddc-a083-1021a3333a48/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_1969207c-fafc-47df-90f6-a4c390272d7d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), heavy hydrocracked",64741-78-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5b79eaa-3527-4ddc-a083-1021a3333a48/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_1969207c-fafc-47df-90f6-a4c390272d7d.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha (petroleum), light alkylate",64741-66-8,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/566217ec-39a9-4883-8ca9-a3b935ed11f0/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_acb105de-1637-498a-b1ab-58a697111eae.html,,,,,, "Naphtha (petroleum), light alkylate",64741-66-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/566217ec-39a9-4883-8ca9-a3b935ed11f0/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_acb105de-1637-498a-b1ab-58a697111eae.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), light alkylate",64741-66-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/566217ec-39a9-4883-8ca9-a3b935ed11f0/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_acb105de-1637-498a-b1ab-58a697111eae.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), light alkylate",64741-66-8," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/566217ec-39a9-4883-8ca9-a3b935ed11f0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_acb105de-1637-498a-b1ab-58a697111eae.html,,,,,, "Naphtha (petroleum), light alkylate",64741-66-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/566217ec-39a9-4883-8ca9-a3b935ed11f0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_acb105de-1637-498a-b1ab-58a697111eae.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light alkylate",64741-66-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/566217ec-39a9-4883-8ca9-a3b935ed11f0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_acb105de-1637-498a-b1ab-58a697111eae.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light alkylate",64741-66-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/566217ec-39a9-4883-8ca9-a3b935ed11f0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_acb105de-1637-498a-b1ab-58a697111eae.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Gasoline, straight-run, topping-plant",68606-11-1,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/402b40d3-5cd0-4b07-b925-79aa49c6ba0f/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_4e699374-0ba1-4065-8a75-de0494613dc7.html,,,,,, "Gasoline, straight-run, topping-plant",68606-11-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/402b40d3-5cd0-4b07-b925-79aa49c6ba0f/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_4e699374-0ba1-4065-8a75-de0494613dc7.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Gasoline, straight-run, topping-plant",68606-11-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/402b40d3-5cd0-4b07-b925-79aa49c6ba0f/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_4e699374-0ba1-4065-8a75-de0494613dc7.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Gasoline, straight-run, topping-plant",68606-11-1," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/402b40d3-5cd0-4b07-b925-79aa49c6ba0f/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_4e699374-0ba1-4065-8a75-de0494613dc7.html,,,,,, "Gasoline, straight-run, topping-plant",68606-11-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/402b40d3-5cd0-4b07-b925-79aa49c6ba0f/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_4e699374-0ba1-4065-8a75-de0494613dc7.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Gasoline, straight-run, topping-plant",68606-11-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/402b40d3-5cd0-4b07-b925-79aa49c6ba0f/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_4e699374-0ba1-4065-8a75-de0494613dc7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gasoline, straight-run, topping-plant",68606-11-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/402b40d3-5cd0-4b07-b925-79aa49c6ba0f/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_4e699374-0ba1-4065-8a75-de0494613dc7.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha (petroleum), hydrodesulfurized light",64742-73-0,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a428908-8979-4664-8157-7d8ea4ef24c0/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_f5ac4fd3-c5e2-4e31-880e-55a0f2bfe8f4.html,,,,,, "Naphtha (petroleum), hydrodesulfurized light",64742-73-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a428908-8979-4664-8157-7d8ea4ef24c0/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_f5ac4fd3-c5e2-4e31-880e-55a0f2bfe8f4.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), hydrodesulfurized light",64742-73-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a428908-8979-4664-8157-7d8ea4ef24c0/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_f5ac4fd3-c5e2-4e31-880e-55a0f2bfe8f4.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), hydrodesulfurized light",64742-73-0," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a428908-8979-4664-8157-7d8ea4ef24c0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_f5ac4fd3-c5e2-4e31-880e-55a0f2bfe8f4.html,,,,,, "Naphtha (petroleum), hydrodesulfurized light",64742-73-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a428908-8979-4664-8157-7d8ea4ef24c0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_f5ac4fd3-c5e2-4e31-880e-55a0f2bfe8f4.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), hydrodesulfurized light",64742-73-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a428908-8979-4664-8157-7d8ea4ef24c0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_f5ac4fd3-c5e2-4e31-880e-55a0f2bfe8f4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), hydrodesulfurized light",64742-73-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a428908-8979-4664-8157-7d8ea4ef24c0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_f5ac4fd3-c5e2-4e31-880e-55a0f2bfe8f4.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, Hydrazinium nitrate,13464-97-6,No data are available on the repeated-dose toxicity of hydrazine mono-nitrate. Data have been waived due to exposure based waiving considerations. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9692887-e0ae-4960-9b4d-f7a0b19d0e4f/documents/IUC5-9ef3d989-b4d5-4464-bcc9-55dab57ac7d9_07432f65-fae3-4e21-8e7b-9cbaee749f54.html,,,,,, Hydrazinium nitrate,13464-97-6,"No data are available for hydrazine mono-nitrate as data have been waived due to the existance of classifications. Data are available for the acute inhalation and dermal toxicity of hydrazine, indicating that it is acutely toxic via this route. Data are also available for the acute oral toxicity of hydrazine hydrate, indicating that it is of low acute toxicity via this route. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9692887-e0ae-4960-9b4d-f7a0b19d0e4f/documents/IUC5-365e065e-4838-4333-9419-d7447fe5904f_07432f65-fae3-4e21-8e7b-9cbaee749f54.html,,,,,, Hydrazinium nitrate,13464-97-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9692887-e0ae-4960-9b4d-f7a0b19d0e4f/documents/IUC5-365e065e-4838-4333-9419-d7447fe5904f_07432f65-fae3-4e21-8e7b-9cbaee749f54.html,,oral,LD50,83 mg/kg bw,, Hydrazinium nitrate,13464-97-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9692887-e0ae-4960-9b4d-f7a0b19d0e4f/documents/IUC5-365e065e-4838-4333-9419-d7447fe5904f_07432f65-fae3-4e21-8e7b-9cbaee749f54.html,,dermal,LD50,91 mg/kg bw,, Hydrazinium nitrate,13464-97-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9692887-e0ae-4960-9b4d-f7a0b19d0e4f/documents/IUC5-365e065e-4838-4333-9419-d7447fe5904f_07432f65-fae3-4e21-8e7b-9cbaee749f54.html,,inhalation,LC50,750 mg/m3,, Strontium chromate,7789-06-2,There are no non-human data on repeated dose effects of strontium chromate. Read-across from sparingly water soluble chromates and from highly water soluble chromates are suggested. Human evidence in several studies with highly water soluble chromates show irritant and corrosive responses in relation to inhalation and dermal exposure. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e995285-608b-4e38-b9ef-4a895c9ae0c5/documents/IUC5-4636777b-a325-4343-90b1-5548e6319d99_92b99627-1dfb-4b38-82cf-558fc6fb6089.html,,,,,, Strontium chromate,7789-06-2,"A valid test on acute inhalation toxicity of strontium chromate exists. In acute oral toxicity, a poorly described study on strontium chromate is notified but the LD50 is based on read-across from a sparingly water soluble chromate. There is no non-human information on acute dermal toxicity of strontium chromate. Human information on strontium chromate is also lacking. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e995285-608b-4e38-b9ef-4a895c9ae0c5/documents/IUC5-44b19af9-7e28-415e-ac22-a9a0331482fa_92b99627-1dfb-4b38-82cf-558fc6fb6089.html,,,,,, Strontium chromate,7789-06-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e995285-608b-4e38-b9ef-4a895c9ae0c5/documents/IUC5-44b19af9-7e28-415e-ac22-a9a0331482fa_92b99627-1dfb-4b38-82cf-558fc6fb6089.html,,oral,LD50,327 mg/kg bw,, Strontium chromate,7789-06-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e995285-608b-4e38-b9ef-4a895c9ae0c5/documents/IUC5-44b19af9-7e28-415e-ac22-a9a0331482fa_92b99627-1dfb-4b38-82cf-558fc6fb6089.html,,inhalation,LC50,270 mg/m3,, Hydroxyprogesterone acetate,302-23-8,"Oral (Rat-Wistar, GLP, non-audited report, OECD TG423): LD50 > 2000 mg/kg[Schering AG, Report No. X053; 1995-11-27]Dermal (Rat-Wistar, GLP, non-audited report, OECD TG402 & 404): LD50 > 2000 mg/kg[Schering AG, Report No. X058; 1996-01-09] ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23869434-ea13-485a-81c9-6c25ff9be21d/documents/IUC5-4c72e641-3eca-49a3-b160-81ee073119a7_f93fbe73-5b49-448e-a20b-c4123cf2a0fa.html,,,,,, "Naphtha (petroleum), heavy catalytic cracked",64741-54-4,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d4a6547-39d8-4095-9e35-af5fce3aeed0/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_e728f7ef-67d8-4be0-bedc-12b200c18926.html,,,,,, "Naphtha (petroleum), heavy catalytic cracked",64741-54-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d4a6547-39d8-4095-9e35-af5fce3aeed0/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_e728f7ef-67d8-4be0-bedc-12b200c18926.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), heavy catalytic cracked",64741-54-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d4a6547-39d8-4095-9e35-af5fce3aeed0/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_e728f7ef-67d8-4be0-bedc-12b200c18926.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), heavy catalytic cracked",64741-54-4," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d4a6547-39d8-4095-9e35-af5fce3aeed0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_e728f7ef-67d8-4be0-bedc-12b200c18926.html,,,,,, "Naphtha (petroleum), heavy catalytic cracked",64741-54-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d4a6547-39d8-4095-9e35-af5fce3aeed0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_e728f7ef-67d8-4be0-bedc-12b200c18926.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), heavy catalytic cracked",64741-54-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d4a6547-39d8-4095-9e35-af5fce3aeed0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_e728f7ef-67d8-4be0-bedc-12b200c18926.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), heavy catalytic cracked",64741-54-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d4a6547-39d8-4095-9e35-af5fce3aeed0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_e728f7ef-67d8-4be0-bedc-12b200c18926.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "3',6'-bis(diethylamino)spiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one",509-34-2," Repeated dose toxicity: oral Since no compound related adverse effects on rats are observed, the no observed adverse effect level (NOAEL) relating to repeated dose for the given test material 3',6'-bis(diethylamino)-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one is estimated to be 742.11 mg/kg/day via oral route of administration. Repeated dose toxicity: inhalation A short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Repeated dose toxicity: dermal The acute toxicity value for substance 3',6'-bis(diethylamino)-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not irritating to skin. Also, given the use of the chemical as dye compound; repeated exposure by the dermal route is unlikely. Thus, it is expected that substance 3',6'-bis(diethylamino)-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no dermal absorption data as well as no data available that suggests that substance 3',6'-bis(diethylamino)-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/654c4f7d-286f-4cb3-87c8-2d9993951489/documents/9553af1c-6fec-46ef-b1f7-4ea4d764531a_20882a50-af96-43ad-a587-3962994ec7b1.html,,,,,, "3',6'-bis(diethylamino)spiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one",509-34-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/654c4f7d-286f-4cb3-87c8-2d9993951489/documents/9553af1c-6fec-46ef-b1f7-4ea4d764531a_20882a50-af96-43ad-a587-3962994ec7b1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,742.11 mg/kg bw/day,,rat "3',6'-bis(diethylamino)spiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one",509-34-2," Acute toxicity: oral Acute oral LD50 value for 3',6'-bis(diethylamino)-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one was estimated to be 1185.2141 mg/kg for rats via oral route. Acute toxicity: inhalation The study need not be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Acute toxicity: dermal Acute dermal LD50 value of the test substance 3',6'-bis(diethylamino)-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one to rabbit was estimated to be 4095.37 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/654c4f7d-286f-4cb3-87c8-2d9993951489/documents/366e1d80-f42b-4f4d-bd0b-bf7e013acd0a_20882a50-af96-43ad-a587-3962994ec7b1.html,,,,,, "3',6'-bis(diethylamino)spiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one",509-34-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/654c4f7d-286f-4cb3-87c8-2d9993951489/documents/366e1d80-f42b-4f4d-bd0b-bf7e013acd0a_20882a50-af96-43ad-a587-3962994ec7b1.html,,oral,LD50,"1,185.214 mg/kg bw",adverse effect observed, "3',6'-bis(diethylamino)spiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one",509-34-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/654c4f7d-286f-4cb3-87c8-2d9993951489/documents/366e1d80-f42b-4f4d-bd0b-bf7e013acd0a_20882a50-af96-43ad-a587-3962994ec7b1.html,,dermal,LD50,"4,095.37 mg/kg bw",, "Gasoline, C5-11, high-octane stabilized reformed",93572-29-3,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/49f786e0-1e28-4d31-ab61-90856769f3bb/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_15d7c256-e84b-4cf4-bf7a-3c8e900ed794.html,,,,,, "Gasoline, C5-11, high-octane stabilized reformed",93572-29-3,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/49f786e0-1e28-4d31-ab61-90856769f3bb/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_15d7c256-e84b-4cf4-bf7a-3c8e900ed794.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Gasoline, C5-11, high-octane stabilized reformed",93572-29-3,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/49f786e0-1e28-4d31-ab61-90856769f3bb/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_15d7c256-e84b-4cf4-bf7a-3c8e900ed794.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Gasoline, C5-11, high-octane stabilized reformed",93572-29-3,"The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401)Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions)Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49f786e0-1e28-4d31-ab61-90856769f3bb/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_15d7c256-e84b-4cf4-bf7a-3c8e900ed794.html,,,,,, "Gasoline, C5-11, high-octane stabilized reformed",93572-29-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49f786e0-1e28-4d31-ab61-90856769f3bb/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_15d7c256-e84b-4cf4-bf7a-3c8e900ed794.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Gasoline, C5-11, high-octane stabilized reformed",93572-29-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49f786e0-1e28-4d31-ab61-90856769f3bb/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_15d7c256-e84b-4cf4-bf7a-3c8e900ed794.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gasoline, C5-11, high-octane stabilized reformed",93572-29-3,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49f786e0-1e28-4d31-ab61-90856769f3bb/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_15d7c256-e84b-4cf4-bf7a-3c8e900ed794.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha (petroleum), light hydrocracked",64741-69-1,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/608db6bb-61e4-4de3-a2e3-c0eb3c0f37b0/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_15a05f4f-4efb-4e02-b0cf-e5c3bed72428.html,,,,,, "Naphtha (petroleum), light hydrocracked",64741-69-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/608db6bb-61e4-4de3-a2e3-c0eb3c0f37b0/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_15a05f4f-4efb-4e02-b0cf-e5c3bed72428.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), light hydrocracked",64741-69-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/608db6bb-61e4-4de3-a2e3-c0eb3c0f37b0/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_15a05f4f-4efb-4e02-b0cf-e5c3bed72428.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), light hydrocracked",64741-69-1," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/608db6bb-61e4-4de3-a2e3-c0eb3c0f37b0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_15a05f4f-4efb-4e02-b0cf-e5c3bed72428.html,,,,,, "Naphtha (petroleum), light hydrocracked",64741-69-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/608db6bb-61e4-4de3-a2e3-c0eb3c0f37b0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_15a05f4f-4efb-4e02-b0cf-e5c3bed72428.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light hydrocracked",64741-69-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/608db6bb-61e4-4de3-a2e3-c0eb3c0f37b0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_15a05f4f-4efb-4e02-b0cf-e5c3bed72428.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light hydrocracked",64741-69-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/608db6bb-61e4-4de3-a2e3-c0eb3c0f37b0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_15a05f4f-4efb-4e02-b0cf-e5c3bed72428.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha (petroleum), heavy catalytic reformed",64741-68-0,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/168927a9-ae9c-4ff5-b5e5-ab4585b544a6/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_eea03942-c6ff-4ca8-b742-3fa3760c269c.html,,,,,, "Naphtha (petroleum), heavy catalytic reformed",64741-68-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/168927a9-ae9c-4ff5-b5e5-ab4585b544a6/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_eea03942-c6ff-4ca8-b742-3fa3760c269c.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), heavy catalytic reformed",64741-68-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/168927a9-ae9c-4ff5-b5e5-ab4585b544a6/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_eea03942-c6ff-4ca8-b742-3fa3760c269c.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), heavy catalytic reformed",64741-68-0," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/168927a9-ae9c-4ff5-b5e5-ab4585b544a6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_eea03942-c6ff-4ca8-b742-3fa3760c269c.html,,,,,, "Naphtha (petroleum), heavy catalytic reformed",64741-68-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/168927a9-ae9c-4ff5-b5e5-ab4585b544a6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_eea03942-c6ff-4ca8-b742-3fa3760c269c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), heavy catalytic reformed",64741-68-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/168927a9-ae9c-4ff5-b5e5-ab4585b544a6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_eea03942-c6ff-4ca8-b742-3fa3760c269c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), heavy catalytic reformed",64741-68-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/168927a9-ae9c-4ff5-b5e5-ab4585b544a6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_eea03942-c6ff-4ca8-b742-3fa3760c269c.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Bis[[R-(R*,S*)]-β-hydroxy-α-methylphenethyl)methylammonium] sulphate",134-72-5,"Six repeated dose studies were performed with two different species (rat and mouse), two different exposure times (14 and 90-days) and two different oral exposure types (via diet and drinking water). It can be concluded that the rat is the most sensitive species. The major adverse effect observed is the loss of body weight (observed in 5 out of 6 studies). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/23834e4b-cf33-41d7-9886-b10767b93b58/documents/IUC5-a0f4701c-199d-41fd-b41b-4ea32d279402_36e93eb4-dff7-43fe-a0ea-9b6c625f4fe1.html,,,,,, "Bis[[R-(R*,S*)]-β-hydroxy-α-methylphenethyl)methylammonium] sulphate",134-72-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/23834e4b-cf33-41d7-9886-b10767b93b58/documents/IUC5-a0f4701c-199d-41fd-b41b-4ea32d279402_36e93eb4-dff7-43fe-a0ea-9b6c625f4fe1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,22 mg/kg bw/day,,rat "Bis[[R-(R*,S*)]-β-hydroxy-α-methylphenethyl)methylammonium] sulphate",134-72-5,In an acute oral toxicity study the LD50 was determined to be 189 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23834e4b-cf33-41d7-9886-b10767b93b58/documents/IUC5-2fb76910-b351-4240-97ca-2d6fbf591d4f_36e93eb4-dff7-43fe-a0ea-9b6c625f4fe1.html,,,,,, "Bis[[R-(R*,S*)]-β-hydroxy-α-methylphenethyl)methylammonium] sulphate",134-72-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23834e4b-cf33-41d7-9886-b10767b93b58/documents/IUC5-2fb76910-b351-4240-97ca-2d6fbf591d4f_36e93eb4-dff7-43fe-a0ea-9b6c625f4fe1.html,,oral,LD50,189 mg/kg bw,adverse effect observed, "Tar acids, methylphenol fraction",84989-04-8,"oral: 90d rat: NOAEL 50 mg/kg bw/day (o-, m- and p-cresol) dermal: cresols are corrosiveinhalation: no valid data available ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b44ea42-8e82-44ad-86dc-b80a00c27df0/documents/IUC5-0ecd836f-9344-4e2c-96e9-0b091f70f283_6a05fa65-3210-4560-9194-943aad6130b3.html,,,,,, "Tar acids, methylphenol fraction",84989-04-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b44ea42-8e82-44ad-86dc-b80a00c27df0/documents/IUC5-0ecd836f-9344-4e2c-96e9-0b091f70f283_6a05fa65-3210-4560-9194-943aad6130b3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Tar acids, methylphenol fraction",84989-04-8,Most critical values of cresols:oral: LD50 rat 121mg/kg bw (o-cresol)dermal: LD50 rat 301mg/kg bw (p-cresol)inhalation: LC50 rat >710mg/m³ (m-cresol and p-cresol) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b44ea42-8e82-44ad-86dc-b80a00c27df0/documents/IUC5-9dd1f0fb-b14f-4a72-b0e8-cdb942d8721e_6a05fa65-3210-4560-9194-943aad6130b3.html,,,,,, "Tar acids, methylphenol fraction",84989-04-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b44ea42-8e82-44ad-86dc-b80a00c27df0/documents/IUC5-9dd1f0fb-b14f-4a72-b0e8-cdb942d8721e_6a05fa65-3210-4560-9194-943aad6130b3.html,,oral,LD50,121 mg/kg bw,, "Tar acids, methylphenol fraction",84989-04-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b44ea42-8e82-44ad-86dc-b80a00c27df0/documents/IUC5-9dd1f0fb-b14f-4a72-b0e8-cdb942d8721e_6a05fa65-3210-4560-9194-943aad6130b3.html,,dermal,LD50,301 mg/kg bw,, "Tar acids, methylphenol fraction",84989-04-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b44ea42-8e82-44ad-86dc-b80a00c27df0/documents/IUC5-9dd1f0fb-b14f-4a72-b0e8-cdb942d8721e_6a05fa65-3210-4560-9194-943aad6130b3.html,,inhalation,LC50,710 mg/m3,, "Tar acids, 3,5-xylenol fraction",84989-07-1,"Repeat Dose Oral Toxicity: Key study: mixed xylenols (28 days combined reproductive / toxicity study). York, 2005. KL.1. NOAEL 100 mg/kg; Supporting study: mixed ethylphenols (28 days combined reproductive / toxicity study). York, 2005. KL.1. NOAEL 100 mg/kg; Supporting study: m-cresol (28 day). MHWL, 2001. KL.1. NOAEL males: 300 mg/kg/day; females: 100 mg/kg/day; Supporting study: p-cresol (28 day). IBTL, 1969. KL.3. NOAEL 45.2 mg/kg/day; Weight of evidence: m-cresol (90 day, oral). RTI, 1988. KL.1. NOAEL: 50 mg/kg/day; Weight of evidence: o-cresol (90 day, oral). RTI, 1988. KL.1. NOAEL: 50 mg/kg/day; Weight of evidence: o-cresol (90 day, diet, rat). RTI, 1988. KL.1. NOAEL males: 247 mg/kg/day; females: 256 mg/kg/day; Weight of evidence: o-cresol (90 day, diet, mouse). RTI, 1988. KL.1. NOAEL males: 199 mg/kg/day; females: 237 mg/kg/day; Weight of evidence: p-cresol (90 day, oral). RTI, 1988. KL.1. NOAEL 50 mg/kg/day; Repeat Dose Dermal Toxicity: No key or supporting studies identifed; Repeat Dose Inhalation Toxicity: No key or supporting studies identifed; ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03b66fb6-cf38-42a9-b259-980ed84aea96/documents/IUC5-86a9f1e4-c37b-4a64-b5fb-f16bb901eb31_8ff54527-d6eb-4abe-a7b2-9662c9664a8e.html,,,,,, "Tar acids, 3,5-xylenol fraction",84989-07-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03b66fb6-cf38-42a9-b259-980ed84aea96/documents/IUC5-86a9f1e4-c37b-4a64-b5fb-f16bb901eb31_8ff54527-d6eb-4abe-a7b2-9662c9664a8e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Tar acids, 3,5-xylenol fraction",84989-07-1,"Acute oral toxicity: Key study -mixed ethylphenols. York, 2005. KL.1. LD50 980.62mg/kg; NOEL 175mg/kg; Supporting study: mixed xylenols. York, 2005. KL.1 LD50 980.62mg/kg; NOEL 175mg/kg; Supporting study: m-cresol. IBTL, 1969. KL.3. NOEL not identified. LOAEL 147mg/kg; Supporting study: o-cresol. IBTL, 1969. KL.3. NOEL not identified. LD50 121mg/kg; LOAEL 68mg/kg; Supporting study: p-cresol. IBTL, 1969. KL.3. NOEL not identified. LD50 207mg/kg; LOAEL 100mg/kg; Acute inhalation toxicity: No key or supporting studies identified; Acute dermal toxicity: No key or supporting studies identified; ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03b66fb6-cf38-42a9-b259-980ed84aea96/documents/IUC5-03fb26f1-06ea-46a2-9224-57ee064b63a9_8ff54527-d6eb-4abe-a7b2-9662c9664a8e.html,,,,,, "Tar acids, 3,5-xylenol fraction",84989-07-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03b66fb6-cf38-42a9-b259-980ed84aea96/documents/IUC5-03fb26f1-06ea-46a2-9224-57ee064b63a9_8ff54527-d6eb-4abe-a7b2-9662c9664a8e.html,,oral,discriminating dose,175 mg/kg bw,, Stoddard solvent,8052-41-3," Oral repeated dose toxicity Groups of 5 rats of each sex were given doses of 0.14 (116 mg/kg), 0.42 (347 mg/kg), or 1.28 (1056 mg/kg) mL/kg of test substance in corn oil for 28 days. Animals were examined for clinical signs, mortality, body weight, food consumption, water consumption, and food conversion. After sacrifice clinical chemistry, hematology, clinical chemistry, urinalysis, organ weights, histopathology, and gross pathology were examined. There was no mortality during the experiment. Renal damage was observed in male rats at all dose levels. This type of renal pathology is specific to male rats due to an alpha2u-globulin-mediated process that is not relevant to humans. Female rats exhibited adaptive liver changes at the highest dosage. There were no pathological findings of the liver and was therefore not considered an adverse effect. The LOAEL for male rats was 0.14 ml/kg/day based on renal damage, which is not relevant to human health. The female NOAEL was 1.28 (1056 mg/kg) mL/kg. Inhalation repeated dose toxicity Sub-chronic exposure to male rats for of 13 weeks(6 h/day, 5 days/week) periods produced no significant finding. The only significant finding was slight to moderate tubular regeneration in male rats which is consistent with alpha-2u-globulin induced nephropathy.  The no-observed-adverse-effect concentration (NOAEC) was considered to be 1100 mg/m³. Dermal repeated dose toxicity The shaved intact skin (15 × 20 cm) of groups of 10 New Zealand White rabbits was exposed to doses of 200, 1000, and 2000 mg/kg of white spirit (Stoddard solvent). Exposure was carried out using occlusion bandage for a duration of 6 h and was given 3 times weekly for 4 weeks. At the highest dose level, there was a significant  reduction in weight gain in both sexes, whereas only the female body  weight gain was reduced at 1000 mg/kg. Changes in haematological parameters noted at 2000 mg/kg were judged not to be treatment-related. At 2000 mg/kg, female rabbits developed liver lesions characterized as white streaks or foci with granular surface ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2230a05c-09fb-4097-8f3e-917c3f092b1c/documents/51b84b30-1b96-4af3-a4d1-4030d4227d7e_d6f3d43e-4e97-4544-b453-94d8d0115a0d.html,,,,,, Stoddard solvent,8052-41-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2230a05c-09fb-4097-8f3e-917c3f092b1c/documents/51b84b30-1b96-4af3-a4d1-4030d4227d7e_d6f3d43e-4e97-4544-b453-94d8d0115a0d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,056 mg/kg bw/day",,rat Stoddard solvent,8052-41-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2230a05c-09fb-4097-8f3e-917c3f092b1c/documents/51b84b30-1b96-4af3-a4d1-4030d4227d7e_d6f3d43e-4e97-4544-b453-94d8d0115a0d.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rabbit Stoddard solvent,8052-41-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2230a05c-09fb-4097-8f3e-917c3f092b1c/documents/51b84b30-1b96-4af3-a4d1-4030d4227d7e_d6f3d43e-4e97-4544-b453-94d8d0115a0d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,100 mg/m3",,rat Stoddard solvent,8052-41-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2230a05c-09fb-4097-8f3e-917c3f092b1c/documents/51b84b30-1b96-4af3-a4d1-4030d4227d7e_d6f3d43e-4e97-4544-b453-94d8d0115a0d.html,Repeated dose toxicity – local effects,dermal,NOAEL,37.8 mg/cm2,no adverse effect observed,rabbit Stoddard solvent,8052-41-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2230a05c-09fb-4097-8f3e-917c3f092b1c/documents/51b84b30-1b96-4af3-a4d1-4030d4227d7e_d6f3d43e-4e97-4544-b453-94d8d0115a0d.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,100 mg/m3",no adverse effect observed,rat Stoddard solvent,8052-41-3," Acute oral toxicity: The LD50 value of >5000 mg/kg for Stoddard Solvent was determined in a rat study. In an acute oral toxicity study, groups of fasted, young adult, Sprague Dawley rats, five male and five female, were given a single oral dose of undiluted Stoddard solvent at a dose of 5000 mg/kg bw and observed for 14 days. There were no treatment related mortalities. All of the study animals exhibited one or more of the following clinical signs: nasal discharge, ocular discharge, abnormal stools, lethargy, stained coat, and alopecia. All animals gained weight during study period. At necropsy, one of the ten animals exhibited visual lesions, the remaining nine showed signs of alopecia in the inguinal and/or perineal regions. The oral LD50 was determined to be greater than 5000 mg/kg in males and females   Acute dermal toxicity:   The LD50 for Stoddard solvent is >3000 mg/kg. Based on these findings, Stoddard solvent does not warrant classification as an acute dermal toxicant under the new Regulation (EC) 1272/2008 on classification, labeling, and packaging of substances and mixtures (CLP) or under the Directive 67/518/EEC for dangerous substances and Directive 1999/45/EC for preparations.   Acute inhalation toxicity:  The 4 hour rat inhalational LC50 for Stoddard solvent is >5.5 mg/L (5500 mg/m3) .No deaths, languid behavior and squinted eyes; 3/5 females exhibited no weight gain during 8 day observation. Based on zero mortality and absence of significant toxicity, body weight observations, and gross post-mortem and histopathological results, in the lungs, it is concluded that Stoddard solvent does not have acute toxic effects under the conditions of this study. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2230a05c-09fb-4097-8f3e-917c3f092b1c/documents/e4870132-3f47-4635-af68-f645cc283955_d6f3d43e-4e97-4544-b453-94d8d0115a0d.html,,,,,, Stoddard solvent,8052-41-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2230a05c-09fb-4097-8f3e-917c3f092b1c/documents/e4870132-3f47-4635-af68-f645cc283955_d6f3d43e-4e97-4544-b453-94d8d0115a0d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Stoddard solvent,8052-41-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2230a05c-09fb-4097-8f3e-917c3f092b1c/documents/e4870132-3f47-4635-af68-f645cc283955_d6f3d43e-4e97-4544-b453-94d8d0115a0d.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, Stoddard solvent,8052-41-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2230a05c-09fb-4097-8f3e-917c3f092b1c/documents/e4870132-3f47-4635-af68-f645cc283955_d6f3d43e-4e97-4544-b453-94d8d0115a0d.html,,inhalation,LC50,"5,500 mg/m3",no adverse effect observed, Beryllium oxide,1304-56-9,No key information generated due to quality of studies. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ddff4dc0-1d5a-446a-a9ed-a761317d97e4/documents/IUC5-77326816-d24e-405a-8e8d-0713a8a0e886_e1c542dc-6956-4b0e-8de3-9094924d0fd3.html,,,,,, Beryllium oxide,1304-56-9,OECD and GLP compliant study on oral acute toxicity is available. LD50 > 2000 mg/kg bw.The other available studies were performed via inhalation or intratracheal intubation. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ddff4dc0-1d5a-446a-a9ed-a761317d97e4/documents/IUC5-4218b89c-36a3-403b-94a4-95bdad18cdfd_e1c542dc-6956-4b0e-8de3-9094924d0fd3.html,,,,,, Beryllium oxide,1304-56-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ddff4dc0-1d5a-446a-a9ed-a761317d97e4/documents/IUC5-4218b89c-36a3-403b-94a4-95bdad18cdfd_e1c542dc-6956-4b0e-8de3-9094924d0fd3.html,,oral,LD50,"2,000 mg/kg bw",, 6-glycidyloxynapht-1-yl oxymethyloxirane,27610-48-6,The Acute oral toxicity to rats of the test item was performed to assess the toxicity following a single oral dose and to determined the LD50.The Dermal toxicity to rats of the test item was performed to assess the toxicity following a single dermal dose and to determined the LD50. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1952cd4-2087-416d-84e3-b33f186acef6/documents/IUC5-a2a87661-30a1-4fce-bece-261892100189_f9343003-6d02-4a35-8235-b11d2f2e881e.html,,,,,, 6-glycidyloxynapht-1-yl oxymethyloxirane,27610-48-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1952cd4-2087-416d-84e3-b33f186acef6/documents/IUC5-a2a87661-30a1-4fce-bece-261892100189_f9343003-6d02-4a35-8235-b11d2f2e881e.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, 6-glycidyloxynapht-1-yl oxymethyloxirane,27610-48-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1952cd4-2087-416d-84e3-b33f186acef6/documents/IUC5-a2a87661-30a1-4fce-bece-261892100189_f9343003-6d02-4a35-8235-b11d2f2e881e.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, Potassium nitrite,7758-09-0," Repeated dose toxicity: Oral A subchronic oral toxicity study with test chemical was carried out in groups of ten male and ten female 6-wk-old rats. No mortality observed and the rats appeared to be healthy throughout the study. Effects were observed in food and water consumption, opthalological and haematological effects were observed. It was concluded that in the study reported here the NOEL is lower than I00 mg /litre in the drinking-water, which is equivalent to a level lower than 10 mg /kg body weight/day and a NOAEL of 300 mg/L drnking water was observed. Repeated dose toxicity: Inhalation According to column 2 of Annex VIII, exposure by inhalation route is negligible on account of high boiling points (as has been informed in the boiling point that is greater than 300 °C).   Repeated dose toxicity: Dermal The acute dermal toxicity value for test chemical is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bbd44243-d825-4f00-a6c3-3eb048e8eb6b/documents/44a8dd7c-ba29-40d9-adc5-1eb793ae89b2_57feddd6-27fd-43c9-8a7a-ff52fc6e8c0d.html,,,,,, Potassium nitrite,7758-09-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bbd44243-d825-4f00-a6c3-3eb048e8eb6b/documents/44a8dd7c-ba29-40d9-adc5-1eb793ae89b2_57feddd6-27fd-43c9-8a7a-ff52fc6e8c0d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Potassium nitrite,7758-09-0," Acute oral toxicity: The experimental study conducted on rabbits for the test chemical was designed to determine acute oral toxicity. The study was conducted in rabbits at the dose concentration of 200 mg/kg bw. 50% mortality was observed. Therefore, LD50 value was considered to be 200 mg/kg, when rabbits were treated with the test chemical via oral route Acute Inhalation toxicity: The acute inhalation toxicity dose LC50 value was considered to be 85000 mg/m3, when mice were exposed with Potassium nitrite (CAS no: 7758-09-0) by inhalation route for 2 hours. Acute dermal toxicity: Under the condition of study; acute dermal toxicity dose (LD50) value for given test chemical was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the given test chemical does not exhibit acute dermal toxicity i.e it is acutely non toxic to animals. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbd44243-d825-4f00-a6c3-3eb048e8eb6b/documents/d0dbf6b5-ee8c-41cb-8cdb-48a5d435ac54_57feddd6-27fd-43c9-8a7a-ff52fc6e8c0d.html,,,,,, Potassium nitrite,7758-09-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbd44243-d825-4f00-a6c3-3eb048e8eb6b/documents/d0dbf6b5-ee8c-41cb-8cdb-48a5d435ac54_57feddd6-27fd-43c9-8a7a-ff52fc6e8c0d.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Potassium nitrite,7758-09-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbd44243-d825-4f00-a6c3-3eb048e8eb6b/documents/d0dbf6b5-ee8c-41cb-8cdb-48a5d435ac54_57feddd6-27fd-43c9-8a7a-ff52fc6e8c0d.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Potassium nitrite,7758-09-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbd44243-d825-4f00-a6c3-3eb048e8eb6b/documents/d0dbf6b5-ee8c-41cb-8cdb-48a5d435ac54_57feddd6-27fd-43c9-8a7a-ff52fc6e8c0d.html,,inhalation,LC50,"85,000 mg/m3",no adverse effect observed, "Residual oils (petroleum), hydrotreated",64742-57-0,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d97105e-7433-4279-801a-6819425e0bcd/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_d16c2bfb-baef-439e-b7d1-37605c941036.html,,,,,, "Residual oils (petroleum), hydrotreated",64742-57-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d97105e-7433-4279-801a-6819425e0bcd/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_d16c2bfb-baef-439e-b7d1-37605c941036.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Residual oils (petroleum), hydrotreated",64742-57-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d97105e-7433-4279-801a-6819425e0bcd/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_d16c2bfb-baef-439e-b7d1-37605c941036.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Residual oils (petroleum), hydrotreated",64742-57-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d97105e-7433-4279-801a-6819425e0bcd/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_d16c2bfb-baef-439e-b7d1-37605c941036.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Residual oils (petroleum), hydrotreated",64742-57-0,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d97105e-7433-4279-801a-6819425e0bcd/documents/73761dae-46d6-428e-8e40-e5cc70088d96_d16c2bfb-baef-439e-b7d1-37605c941036.html,,,,,, "Residual oils (petroleum), hydrotreated",64742-57-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d97105e-7433-4279-801a-6819425e0bcd/documents/73761dae-46d6-428e-8e40-e5cc70088d96_d16c2bfb-baef-439e-b7d1-37605c941036.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Residual oils (petroleum), hydrotreated",64742-57-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d97105e-7433-4279-801a-6819425e0bcd/documents/73761dae-46d6-428e-8e40-e5cc70088d96_d16c2bfb-baef-439e-b7d1-37605c941036.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residual oils (petroleum), hydrotreated",64742-57-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d97105e-7433-4279-801a-6819425e0bcd/documents/73761dae-46d6-428e-8e40-e5cc70088d96_d16c2bfb-baef-439e-b7d1-37605c941036.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Naphtha (petroleum), light, sweetened",68783-66-4,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e8bdb17-c534-4e32-a010-abf2240d3ee7/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_27636af6-7654-4217-af4d-1e441ea132e9.html,,,,,, "Naphtha (petroleum), light, sweetened",68783-66-4,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e8bdb17-c534-4e32-a010-abf2240d3ee7/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_27636af6-7654-4217-af4d-1e441ea132e9.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), light, sweetened",68783-66-4,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e8bdb17-c534-4e32-a010-abf2240d3ee7/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_27636af6-7654-4217-af4d-1e441ea132e9.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), light, sweetened",68783-66-4,"The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401)Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions)Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e8bdb17-c534-4e32-a010-abf2240d3ee7/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_27636af6-7654-4217-af4d-1e441ea132e9.html,,,,,, "Naphtha (petroleum), light, sweetened",68783-66-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e8bdb17-c534-4e32-a010-abf2240d3ee7/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_27636af6-7654-4217-af4d-1e441ea132e9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light, sweetened",68783-66-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e8bdb17-c534-4e32-a010-abf2240d3ee7/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_27636af6-7654-4217-af4d-1e441ea132e9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light, sweetened",68783-66-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e8bdb17-c534-4e32-a010-abf2240d3ee7/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_27636af6-7654-4217-af4d-1e441ea132e9.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha (petroleum), isomerization, C6-fraction",92045-58-4,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9a23dd6-9aa8-4614-9424-a6d38174a9ce/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_75155447-fd11-407b-8a1e-d4ac5e821840.html,,,,,, "Naphtha (petroleum), isomerization, C6-fraction",92045-58-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9a23dd6-9aa8-4614-9424-a6d38174a9ce/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_75155447-fd11-407b-8a1e-d4ac5e821840.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), isomerization, C6-fraction",92045-58-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9a23dd6-9aa8-4614-9424-a6d38174a9ce/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_75155447-fd11-407b-8a1e-d4ac5e821840.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), isomerization, C6-fraction",92045-58-4," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9a23dd6-9aa8-4614-9424-a6d38174a9ce/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_75155447-fd11-407b-8a1e-d4ac5e821840.html,,,,,, "Naphtha (petroleum), isomerization, C6-fraction",92045-58-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9a23dd6-9aa8-4614-9424-a6d38174a9ce/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_75155447-fd11-407b-8a1e-d4ac5e821840.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), isomerization, C6-fraction",92045-58-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9a23dd6-9aa8-4614-9424-a6d38174a9ce/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_75155447-fd11-407b-8a1e-d4ac5e821840.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), isomerization, C6-fraction",92045-58-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9a23dd6-9aa8-4614-9424-a6d38174a9ce/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_75155447-fd11-407b-8a1e-d4ac5e821840.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Hydrocarbons, C5-rich",68476-55-1," Repeat dose studies on two C5 non-cyclics streams and two major constituents of these streams have been considered. There is evidence of specific target organ toxicity in several studies. A finding common to several of the studies is kidney changes characteristic of hyaline droplet nephropathy in male rats. This male rat-specific effect is considered not to be relevant to humans. Although C5 non-cyclics streams may contain low levels of benzene and/or toluene, streams containing levels equal to or above 1% would classification for specific target organ systemic toxicity after repeated exposure. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45c98148-1032-4d1d-b333-325848a6f8bc/documents/IUC5-e2dae253-2c40-4ec7-8171-8bfa2e9516fc_d9ccf160-5b37-4e57-b902-1361f46b628a.html,,,,,, "Hydrocarbons, C5-rich",68476-55-1," As C5 non-cyclics streams are inherently of unknown and variable composition, and taking into consideration the possible percentages of constituents which are acutely toxic it is proposed that all streams are classified as harmful via oral and dermal exposure routes. Two of the constituents, 2-methyl-2-butene and cyclopentene, are classified as harmful under GHS via the oral route and cyclopentene is also classified as harmful via the dermal route. 2-Methyl-2- butene vapour causes drowsiness and dizziness. Due to their low kinematic viscosity C5 non-cyclics also represent an aspiration hazard. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45c98148-1032-4d1d-b333-325848a6f8bc/documents/IUC5-4a1915b2-ab0e-4c0e-88eb-eaf7b3efde7f_d9ccf160-5b37-4e57-b902-1361f46b628a.html,,,,,, Tetramethylthiuram monosulphide,97-74-5,"An oral (gavage) combined repeated dose study with a repro/developmental toxicity screening was performed in rat according to OECD TG 422 and in accordance with GLP. Based on these results of the study, the No Observed Adverse Effect Level (NOAEL) for parental toxicity was considered to be 10 mg/kg bw/day in males and 5 mg/kg bw/day in females based on adverse effects (i.e. mortality, clinical signs, low body weights and body weight changes and/or reduced food consumption) observed in males at 30 mg/kg bw/day and in females from 10 mg/kg bw/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP-compliant study conducted in accordance with a relevant OECD Testing Guideline. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44799987-0528-4c8d-bf5a-6cd6115ff31d/documents/IUC5-e9c097ac-b067-452a-a973-494843e50aa5_3303c410-5c22-4d73-bd5a-0ff94bf593fb.html,,,,,, Tetramethylthiuram monosulphide,97-74-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44799987-0528-4c8d-bf5a-6cd6115ff31d/documents/IUC5-e9c097ac-b067-452a-a973-494843e50aa5_3303c410-5c22-4d73-bd5a-0ff94bf593fb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat Tetramethylthiuram monosulphide,97-74-5,"Several acute studies are available by oral route, all of the studies showed a LD50 between 690 and 1400 mg/kg in rodents (rats and mice).The acute study by inhalation on an analogue of TMTM: TMTD (aerosol) showed a combined LC50 of 4.42 mg/L in rats.Two reliable acute studies are available by dermal route, one on rats and one on rabbits, showed a LD50 higher than 2000 mg/kg. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Löser's study is a reliable study with a klimisch score of 1. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Holbert's study is a reliable study with a klimisch score of 1. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The silvano's study is a reliable study with a klimisch score of 1. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44799987-0528-4c8d-bf5a-6cd6115ff31d/documents/IUC5-b2de0f5d-f350-4bf5-b2b4-6d1fc081a6c7_3303c410-5c22-4d73-bd5a-0ff94bf593fb.html,,,,,, Tetramethylthiuram monosulphide,97-74-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44799987-0528-4c8d-bf5a-6cd6115ff31d/documents/IUC5-b2de0f5d-f350-4bf5-b2b4-6d1fc081a6c7_3303c410-5c22-4d73-bd5a-0ff94bf593fb.html,,oral,LD50,690 mg/kg bw,adverse effect observed, Tetramethylthiuram monosulphide,97-74-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44799987-0528-4c8d-bf5a-6cd6115ff31d/documents/IUC5-b2de0f5d-f350-4bf5-b2b4-6d1fc081a6c7_3303c410-5c22-4d73-bd5a-0ff94bf593fb.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Tetramethylthiuram monosulphide,97-74-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44799987-0528-4c8d-bf5a-6cd6115ff31d/documents/IUC5-b2de0f5d-f350-4bf5-b2b4-6d1fc081a6c7_3303c410-5c22-4d73-bd5a-0ff94bf593fb.html,,inhalation,LC50,"4,420 mg/m3",adverse effect observed, Chloroacetaldehyde,107-20-0,"Chloroacetaldeyhde is highly toxic via oral, inhalative and dermal route. All acute studies show severe corrosive effects on skin and eyes.Due to the hazardous properties of a 45% solution and the risk of an exothermic condensation reaction at acidic pH and/or elevated temperature the pure substanceis not isolated for safety reasons. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be88f0f3-62ab-4175-927f-8f09a949939d/documents/IUC5-2546dbd5-21ca-4c0b-8521-8e4d5dd33202_e0676359-a2ca-4624-b851-afcb5dcc3069.html,,,,,, Chloroacetaldehyde,107-20-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be88f0f3-62ab-4175-927f-8f09a949939d/documents/IUC5-2546dbd5-21ca-4c0b-8521-8e4d5dd33202_e0676359-a2ca-4624-b851-afcb5dcc3069.html,,oral,LD50,133 mg/kg bw,adverse effect observed, Chloroacetaldehyde,107-20-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be88f0f3-62ab-4175-927f-8f09a949939d/documents/IUC5-2546dbd5-21ca-4c0b-8521-8e4d5dd33202_e0676359-a2ca-4624-b851-afcb5dcc3069.html,,dermal,LD50,140 mg/kg bw,adverse effect observed, Chloroacetaldehyde,107-20-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be88f0f3-62ab-4175-927f-8f09a949939d/documents/IUC5-2546dbd5-21ca-4c0b-8521-8e4d5dd33202_e0676359-a2ca-4624-b851-afcb5dcc3069.html,,inhalation,LC50,650 mg/m3,adverse effect observed, "Gas oils (petroleum), hydrodesulfurized heavy vacuum",64742-86-5," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3b616dd-4f0d-4237-8c5f-c680c2f8dc79/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_5ec6047e-74a2-4ea7-967f-63d6f4eb0829.html,,,,,, "Gas oils (petroleum), hydrodesulfurized heavy vacuum",64742-86-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3b616dd-4f0d-4237-8c5f-c680c2f8dc79/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_5ec6047e-74a2-4ea7-967f-63d6f4eb0829.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Gas oils (petroleum), hydrodesulfurized heavy vacuum",64742-86-5,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3b616dd-4f0d-4237-8c5f-c680c2f8dc79/documents/12190120-6b6e-49c5-bed7-264eab246437_5ec6047e-74a2-4ea7-967f-63d6f4eb0829.html,,,,,, "Gas oils (petroleum), hydrodesulfurized heavy vacuum",64742-86-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3b616dd-4f0d-4237-8c5f-c680c2f8dc79/documents/12190120-6b6e-49c5-bed7-264eab246437_5ec6047e-74a2-4ea7-967f-63d6f4eb0829.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), hydrodesulfurized heavy vacuum",64742-86-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3b616dd-4f0d-4237-8c5f-c680c2f8dc79/documents/12190120-6b6e-49c5-bed7-264eab246437_5ec6047e-74a2-4ea7-967f-63d6f4eb0829.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), hydrodesulfurized heavy vacuum",64742-86-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3b616dd-4f0d-4237-8c5f-c680c2f8dc79/documents/12190120-6b6e-49c5-bed7-264eab246437_5ec6047e-74a2-4ea7-967f-63d6f4eb0829.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "Fuel oil, residues-straight-run gas oils, high-sulfur",68476-32-4,"No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components.Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e13f6be-88b3-4c63-aeff-fcba79210924/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_5b16ba6c-f925-48ff-aed4-2ba14a012bd6.html,,,,,, "Fuel oil, residues-straight-run gas oils, high-sulfur",68476-32-4,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e13f6be-88b3-4c63-aeff-fcba79210924/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_5b16ba6c-f925-48ff-aed4-2ba14a012bd6.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Fuel oil, residues-straight-run gas oils, high-sulfur",68476-32-4,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e13f6be-88b3-4c63-aeff-fcba79210924/documents/12190120-6b6e-49c5-bed7-264eab246437_5b16ba6c-f925-48ff-aed4-2ba14a012bd6.html,,,,,, "Fuel oil, residues-straight-run gas oils, high-sulfur",68476-32-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e13f6be-88b3-4c63-aeff-fcba79210924/documents/12190120-6b6e-49c5-bed7-264eab246437_5b16ba6c-f925-48ff-aed4-2ba14a012bd6.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Fuel oil, residues-straight-run gas oils, high-sulfur",68476-32-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e13f6be-88b3-4c63-aeff-fcba79210924/documents/12190120-6b6e-49c5-bed7-264eab246437_5b16ba6c-f925-48ff-aed4-2ba14a012bd6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fuel oil, residues-straight-run gas oils, high-sulfur",68476-32-4,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e13f6be-88b3-4c63-aeff-fcba79210924/documents/12190120-6b6e-49c5-bed7-264eab246437_5b16ba6c-f925-48ff-aed4-2ba14a012bd6.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, Dimethylamine,124-40-3," Repeated dose toxicity: oral exposure Darad et al.,1983, Toxicology Letters, 17 (1983) 125-130, 30 rats (Wistar), exposed daily via drinking water. The results are indicating a free radical-mediated damage to the cellular and subcellular membranes. In conclusion DMA is able to disturb the barrier function of the skin by altering the protective characteristics. Repeated dose toxicity: inhalation exposure Buckley et al., 1985, Fundamental applied toxicology.V. 5, 341-352 (1985), exposure of rats or mice by inhalation to 0, 10, 50, or 175 ppm dimethylamine (DMA) for 6 hr/day, 5 days/week for 12 months. LOAEC = 10 ppm = 18.45 mg/m³ for local effects and NOAEC (systemic) = 50 ppm = 92.26 mg/m³ for systemic effects (conversion of ppm value into mg/m³ value was performed taking into account the temperature of 76 °F of the Buckley study).   Repeated dose toxicity: dermal exposure no study available ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24d202b4-40c0-473c-8fab-73bd7b9925e2/documents/IUC5-e7f6a687-7801-498c-9cd8-67472d1bb28c_9eabbc45-5649-4301-8097-8d1e1c580fe1.html,,,,,, Dimethylamine,124-40-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24d202b4-40c0-473c-8fab-73bd7b9925e2/documents/IUC5-e7f6a687-7801-498c-9cd8-67472d1bb28c_9eabbc45-5649-4301-8097-8d1e1c580fe1.html,Chronic toxicity – systemic effects,inhalation,NOAEC,92.26 mg/m3,,rat Dimethylamine,124-40-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24d202b4-40c0-473c-8fab-73bd7b9925e2/documents/IUC5-e7f6a687-7801-498c-9cd8-67472d1bb28c_9eabbc45-5649-4301-8097-8d1e1c580fe1.html,Repeated dose toxicity – local effects,inhalation,LOAEC,18.45 mg/m3,adverse effect observed,rat Dimethylamine,124-40-3," Oral: BASF, Gewerbetoxikologische Grundprüfung, 1980. Dermal: BASF, Gewerbetoxikologische Grundprüfung, 1980. Inhalation: International research and development corporation, 1992, rats (1 hour exposure) (for C&L). Inhalation: Gagnaire, 1989, mice. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24d202b4-40c0-473c-8fab-73bd7b9925e2/documents/IUC5-80c32562-4e9c-4e3c-ad63-47d07b5a30cc_9eabbc45-5649-4301-8097-8d1e1c580fe1.html,,,,,, Dimethylamine,124-40-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24d202b4-40c0-473c-8fab-73bd7b9925e2/documents/IUC5-80c32562-4e9c-4e3c-ad63-47d07b5a30cc_9eabbc45-5649-4301-8097-8d1e1c580fe1.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, Dimethylamine,124-40-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24d202b4-40c0-473c-8fab-73bd7b9925e2/documents/IUC5-80c32562-4e9c-4e3c-ad63-47d07b5a30cc_9eabbc45-5649-4301-8097-8d1e1c580fe1.html,,dermal,LD50,"3,900 mg/kg bw",no adverse effect observed, Dimethylamine,124-40-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24d202b4-40c0-473c-8fab-73bd7b9925e2/documents/IUC5-80c32562-4e9c-4e3c-ad63-47d07b5a30cc_9eabbc45-5649-4301-8097-8d1e1c580fe1.html,,inhalation,LC50,"4,876.76 mg/m3",adverse effect observed, Sodium cyanide,143-33-9,"The repeated dose toxicity of cyanide salts is based on effects observed from related compounds, hydrogen cyanide and acetone cyanohydrins. All category members behave similarly in generating HCN at the physiological pH of 7, and are not present as either the salt or the free CN‾ ion. As there is a significant body of data on human exposure to cyanides, this data is utilized over animal data for derivation of the DNELs The level of blood thiocyanate which is without adverse effect on the thyroid gland or other organs is established, and chronic exposure resulting in this value is calculated as an acceptable limit (see ECETOC, 2007 approach in the JACC Report No. 53). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41f72645-0644-40fb-951a-978b0ace91d3/documents/IUC5-6b065dfe-1159-447a-bd8a-403637d2798d_f8a036d5-5ab2-4993-b1d8-b1847beb36b1.html,,,,,, Sodium cyanide,143-33-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41f72645-0644-40fb-951a-978b0ace91d3/documents/IUC5-6b065dfe-1159-447a-bd8a-403637d2798d_f8a036d5-5ab2-4993-b1d8-b1847beb36b1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,1.02 mg/kg bw/day,, Sodium cyanide,143-33-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41f72645-0644-40fb-951a-978b0ace91d3/documents/IUC5-6b065dfe-1159-447a-bd8a-403637d2798d_f8a036d5-5ab2-4993-b1d8-b1847beb36b1.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,3.75 mg/m3,, Sodium cyanide,143-33-9,"Sodium or potassium cyanide is an alkali salt of the anion, cyanide, CN-, which is the solitary functional group which defines its chemical and toxicologic activity. The salt is soluble in water, resulting in the immediate formation of HCN, as the pKa value (dissociation constant) is 9.11 at 30°C. At the physiological pH of about 7, cyanide salts are distributed in the body as HCN and are not present as either the salt or the free CN‾ ion. Data are available for the estimation of dose descriptors and DNELs in humans, thus avoiding extrapolation from animal species. Calculations on LD50 values from animal studies provide comparable values for DNELs. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41f72645-0644-40fb-951a-978b0ace91d3/documents/IUC5-7b5776f3-446c-4954-a5d3-2b0d5b202351_f8a036d5-5ab2-4993-b1d8-b1847beb36b1.html,,,,,, Sodium cyanide,143-33-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41f72645-0644-40fb-951a-978b0ace91d3/documents/IUC5-7b5776f3-446c-4954-a5d3-2b0d5b202351_f8a036d5-5ab2-4993-b1d8-b1847beb36b1.html,,oral,LD50,5.09 mg/kg bw,, Sodium cyanide,143-33-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41f72645-0644-40fb-951a-978b0ace91d3/documents/IUC5-7b5776f3-446c-4954-a5d3-2b0d5b202351_f8a036d5-5ab2-4993-b1d8-b1847beb36b1.html,,dermal,LD50,11.28 mg/kg bw,, Sodium cyanide,143-33-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41f72645-0644-40fb-951a-978b0ace91d3/documents/IUC5-7b5776f3-446c-4954-a5d3-2b0d5b202351_f8a036d5-5ab2-4993-b1d8-b1847beb36b1.html,,inhalation,LC50,103 mg/m3,, "4-(phenylazo)benzene-1,3-diamine",495-54-5,"Acute Toxicity : Oral  Under the condition of the study, the acute oral LD50 (Cut-off value) of 4-(phenylazo)benzene-1,3-diamine (CAS No. 495-54-5) was 1000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of 4-(phenylazo)benzene-1,3-diamine (CAS No. 495-54-5), when administered via oral route in Sprague Dawley rats falls into the “Category 4 (300 – ≤ 2000)” criteria of CLP. Acute Toxicity : Inhalation Waiver Acute TOxicity : Dermal  It was concluded that the acute dermal median lethal dose (LD50) of 4-(phenylazo)benzene-1,3-diamine (CAS No. 495-54-5), when administered to male and female Sprague Dawley rats was found to be greater than 2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that 4-(phenylazo)benzene-1,3-diamine (CAS No. 495-54-5) does not classify as an acute dermal toxicant.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimish K1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Waiver Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimish K1 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ca817da-2bb6-481e-8deb-93cf24adecb9/documents/272fc83c-20e5-49cc-975c-ee1f9d1fec37_d5ce6eda-a9cc-4654-91c8-af337f841d77.html,,,,,, "4-(phenylazo)benzene-1,3-diamine",495-54-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ca817da-2bb6-481e-8deb-93cf24adecb9/documents/272fc83c-20e5-49cc-975c-ee1f9d1fec37_d5ce6eda-a9cc-4654-91c8-af337f841d77.html,,oral,LD50,"1,000 ",adverse effect observed, "4-(phenylazo)benzene-1,3-diamine",495-54-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ca817da-2bb6-481e-8deb-93cf24adecb9/documents/272fc83c-20e5-49cc-975c-ee1f9d1fec37_d5ce6eda-a9cc-4654-91c8-af337f841d77.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated heavy naphthenic",64742-52-5,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/15755594-7a2d-495a-a47b-da688bdce43f/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_7ede97fc-afca-4f95-811f-1254c244e30c.html,,,,,, "Distillates (petroleum), hydrotreated heavy naphthenic",64742-52-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/15755594-7a2d-495a-a47b-da688bdce43f/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_7ede97fc-afca-4f95-811f-1254c244e30c.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Distillates (petroleum), hydrotreated heavy naphthenic",64742-52-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/15755594-7a2d-495a-a47b-da688bdce43f/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_7ede97fc-afca-4f95-811f-1254c244e30c.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Distillates (petroleum), hydrotreated heavy naphthenic",64742-52-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/15755594-7a2d-495a-a47b-da688bdce43f/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_7ede97fc-afca-4f95-811f-1254c244e30c.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Distillates (petroleum), hydrotreated heavy naphthenic",64742-52-5,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15755594-7a2d-495a-a47b-da688bdce43f/documents/73761dae-46d6-428e-8e40-e5cc70088d96_7ede97fc-afca-4f95-811f-1254c244e30c.html,,,,,, "Distillates (petroleum), hydrotreated heavy naphthenic",64742-52-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15755594-7a2d-495a-a47b-da688bdce43f/documents/73761dae-46d6-428e-8e40-e5cc70088d96_7ede97fc-afca-4f95-811f-1254c244e30c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated heavy naphthenic",64742-52-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15755594-7a2d-495a-a47b-da688bdce43f/documents/73761dae-46d6-428e-8e40-e5cc70088d96_7ede97fc-afca-4f95-811f-1254c244e30c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated heavy naphthenic",64742-52-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15755594-7a2d-495a-a47b-da688bdce43f/documents/73761dae-46d6-428e-8e40-e5cc70088d96_7ede97fc-afca-4f95-811f-1254c244e30c.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, 1-phenylazo-2-naphthol,842-07-9," Repeated dose toxicity: oral Repeated dose oral toxicity study was performed on mice to determine the toxic nature of 1-phenylazo-2-naphthol (C. I. Solvent Yellow 14). In a 14 day repeated dose toxicity study,  B6C3F1male and female mice were treated with C. I. Solvent Yellow 14 in the concentration of 0,6,000, 12,500, 25,000, 50,000, or 100,000 ppm ( 0, 1200, 2500, 5000, 10000 and 20000 mg/kg/day) orally in diet. All male and female mice were died at 12500, 25000, 50000 and 100000 ppm (2500, 5000, 1000 and 20000 mg/kg/day) dose. The mice were observed for clinical signs and mortality, gross and histopathology. No clinical signs of toxicity were noted and severe gross pathological effects such as dark red intestines and mildly congested livers were observed at 2500 mg/Kg/day and at higher doses. Therefore, No Observed Adverse Effect Level (NOAEL) was 1200 mg/kg/day when B6C3F1 male and female mice were treated with 1-phenylazo-2-naphthol (C. I. Solvent Yellow 14). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eddab513-a3b1-41ae-836c-dd54f29ccbe9/documents/db7497d8-12fb-47e1-86b2-820141f66787_52a3c7d2-e27d-48d8-aaf3-770852b7aa26.html,,,,,, 1-phenylazo-2-naphthol,842-07-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eddab513-a3b1-41ae-836c-dd54f29ccbe9/documents/db7497d8-12fb-47e1-86b2-820141f66787_52a3c7d2-e27d-48d8-aaf3-770852b7aa26.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,mouse 1-phenylazo-2-naphthol,842-07-9," Acute toxicity: oral LD50 was considered to be > 10000 mg/kg bw when rats were treated with 1-phenylazo-2-naphthol (Sudanorange R) as a 5-35% suspension in 0.5% aqueous CMC preparation orally by gavage.  Acute toxicity: inhalation LD50 was considered to be > 200000 mg/m3 in air when rats were exposed with 1-phenylazo-2-naphthol (Sudanorange R) by inhalation route. Acute toxicity: dermal The acute toxicity study was predicted using OECD QSAR toolbox version 3.3 (2017) with log kow as the primary descriptor; to evaluate the toxic effects of administration of 1-phenylazo-2-naphthol (C. I. Solvent Yellow 14) (CAS No. 842-07-9) in rabbits by the dermal route. 50% mortality was observed at 2962.15 mg/kg bw in treated rabbit.The acute dermal median lethal dose (LD50) of 1-phenylazo-2-naphthol (C. I. Solvent Yellow 14) in rabbit was estimated to be 2962.15 mg/kg bw. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that 1-phenylazo-2-naphthol (C. I. Solvent Yellow 14) (CAS No. 842-07-9) does not classify as an acute dermal toxicant. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eddab513-a3b1-41ae-836c-dd54f29ccbe9/documents/6e426237-7a14-40f9-bd59-f5eda1eee911_52a3c7d2-e27d-48d8-aaf3-770852b7aa26.html,,,,,, 1-phenylazo-2-naphthol,842-07-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eddab513-a3b1-41ae-836c-dd54f29ccbe9/documents/6e426237-7a14-40f9-bd59-f5eda1eee911_52a3c7d2-e27d-48d8-aaf3-770852b7aa26.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, 1-phenylazo-2-naphthol,842-07-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eddab513-a3b1-41ae-836c-dd54f29ccbe9/documents/6e426237-7a14-40f9-bd59-f5eda1eee911_52a3c7d2-e27d-48d8-aaf3-770852b7aa26.html,,dermal,LD50,"2,962.15 mg/kg bw",no adverse effect observed, 1-phenylazo-2-naphthol,842-07-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eddab513-a3b1-41ae-836c-dd54f29ccbe9/documents/6e426237-7a14-40f9-bd59-f5eda1eee911_52a3c7d2-e27d-48d8-aaf3-770852b7aa26.html,,inhalation,LC50,"200,000 mg/m3",no adverse effect observed, "4-(phenylazo)benzene-1,3-diamine acetate",79234-33-6," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target substance 4-(phenylazo)benzene-1,3-diamine acetate(79234-33-6) was estimated to be 694.42 mg/kg bw,and for different studies available on the structurally similar read across substance 4-(phenylazo)benzene-1,3-diamine (CAS No. 495-54-5) was considered to be 1000 mg/kg bw and for 2,6-DIAMINO-3-(PHENYLAZO)PYRIDINE (94-78-0) was considered to be 403 mg/kg bw. All these studies concluded that the LD50 value is between 300-2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 4-(phenylazo)benzene-1,3-diamine acetate(79234-33-6) can be classified as “Category IV” for acute oral toxicity. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b74813ae-c7d2-4b2e-a1e2-2d015d98c90a/documents/962ada0b-8a2e-4eb6-aa89-3ca5c1acd580_360ece66-6777-4d7c-a24a-847886794990.html,,,,,, "4-(phenylazo)benzene-1,3-diamine acetate",79234-33-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b74813ae-c7d2-4b2e-a1e2-2d015d98c90a/documents/962ada0b-8a2e-4eb6-aa89-3ca5c1acd580_360ece66-6777-4d7c-a24a-847886794990.html,,oral,LD50,694.42 mg/kg bw,adverse effect observed, "Lubricating oils (petroleum), C>25, solvent-extd., deasphalted, dewaxed, hydrogenated",101316-69-2,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7256c69-b62f-4680-8786-35e41763d240/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_76267a55-0e97-4a32-99f2-ddc3f08e22d8.html,,,,,, "Lubricating oils (petroleum), C>25, solvent-extd., deasphalted, dewaxed, hydrogenated",101316-69-2,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7256c69-b62f-4680-8786-35e41763d240/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_76267a55-0e97-4a32-99f2-ddc3f08e22d8.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Lubricating oils (petroleum), C>25, solvent-extd., deasphalted, dewaxed, hydrogenated",101316-69-2,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7256c69-b62f-4680-8786-35e41763d240/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_76267a55-0e97-4a32-99f2-ddc3f08e22d8.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Lubricating oils (petroleum), C>25, solvent-extd., deasphalted, dewaxed, hydrogenated",101316-69-2,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7256c69-b62f-4680-8786-35e41763d240/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_76267a55-0e97-4a32-99f2-ddc3f08e22d8.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Lubricating oils (petroleum), C>25, solvent-extd., deasphalted, dewaxed, hydrogenated",101316-69-2,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7256c69-b62f-4680-8786-35e41763d240/documents/73761dae-46d6-428e-8e40-e5cc70088d96_76267a55-0e97-4a32-99f2-ddc3f08e22d8.html,,,,,, "Lubricating oils (petroleum), C>25, solvent-extd., deasphalted, dewaxed, hydrogenated",101316-69-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7256c69-b62f-4680-8786-35e41763d240/documents/73761dae-46d6-428e-8e40-e5cc70088d96_76267a55-0e97-4a32-99f2-ddc3f08e22d8.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Lubricating oils (petroleum), C>25, solvent-extd., deasphalted, dewaxed, hydrogenated",101316-69-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7256c69-b62f-4680-8786-35e41763d240/documents/73761dae-46d6-428e-8e40-e5cc70088d96_76267a55-0e97-4a32-99f2-ddc3f08e22d8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Lubricating oils (petroleum), C>25, solvent-extd., deasphalted, dewaxed, hydrogenated",101316-69-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7256c69-b62f-4680-8786-35e41763d240/documents/73761dae-46d6-428e-8e40-e5cc70088d96_76267a55-0e97-4a32-99f2-ddc3f08e22d8.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Distillates (petroleum), heavy paraffinic",64741-51-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88fe7195-69dc-4a13-bf6b-cd216b534802/documents/5af7fd89-2b85-4d09-95c9-bff5096e2551_4462be7f-ac18-4c49-b244-2b8d61b89d33.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,500 mg/m3",,rat "Distillates (petroleum), heavy paraffinic",64741-51-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88fe7195-69dc-4a13-bf6b-cd216b534802/documents/5af7fd89-2b85-4d09-95c9-bff5096e2551_4462be7f-ac18-4c49-b244-2b8d61b89d33.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Distillates (petroleum), heavy paraffinic",64741-51-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88fe7195-69dc-4a13-bf6b-cd216b534802/documents/5af7fd89-2b85-4d09-95c9-bff5096e2551_4462be7f-ac18-4c49-b244-2b8d61b89d33.html,Sub-chronic toxicity – systemic effects,dermal,LOAEL,30 mg/kg bw/day,,rat "Distillates (petroleum), heavy paraffinic",64741-51-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88fe7195-69dc-4a13-bf6b-cd216b534802/documents/5af7fd89-2b85-4d09-95c9-bff5096e2551_4462be7f-ac18-4c49-b244-2b8d61b89d33.html,Repeated dose toxicity – local effects,dermal,LOAEL,12.5 mg/cm2,adverse effect observed,rabbit "Distillates (petroleum), heavy paraffinic",64741-51-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88fe7195-69dc-4a13-bf6b-cd216b534802/documents/5af7fd89-2b85-4d09-95c9-bff5096e2551_4462be7f-ac18-4c49-b244-2b8d61b89d33.html,Repeated dose toxicity – local effects,inhalation,NOAEC,500 mg/m3,adverse effect observed,rat "Distillates (petroleum), heavy paraffinic",64741-51-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88fe7195-69dc-4a13-bf6b-cd216b534802/documents/52eeeb26-c313-4153-a707-482add55ac03_4462be7f-ac18-4c49-b244-2b8d61b89d33.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), heavy paraffinic",64741-51-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88fe7195-69dc-4a13-bf6b-cd216b534802/documents/52eeeb26-c313-4153-a707-482add55ac03_4462be7f-ac18-4c49-b244-2b8d61b89d33.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), heavy paraffinic",64741-51-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88fe7195-69dc-4a13-bf6b-cd216b534802/documents/52eeeb26-c313-4153-a707-482add55ac03_4462be7f-ac18-4c49-b244-2b8d61b89d33.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Hydrocarbons, C4, 1,3-butadiene- and isobutene-free",95465-89-7,"Members of the C4 low 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams in this category (CAS Numbers; 91052-98-1, 92045-23-3, 95465-89-7, 95465-90-0 and 95465-91-1) but data on the constituents (butane, isobutane and butene isomers) indicate that members of this category have low sub-chronic toxicity. Inhalation exposure is the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies in rats or mice for 6 weeks (butane and isobutane) or up to 2 years (butene isomers). Nasal lesions were observed in 2 year rodent studies on 2-methylpropene at the highest concentration and the NOAEC of 2000 ppm (4589 mg/m3) in rats is based on the lack of effect at this concentration. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c97495b9-bbd2-4d92-9072-bbae952707c8/documents/IUC5-c3aaa45f-6e5d-41d7-b934-e2001e4813c2_dfbd363a-09c6-40cf-93ba-ec084ee57a8e.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene- and isobutene-free",95465-89-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c97495b9-bbd2-4d92-9072-bbae952707c8/documents/IUC5-c3aaa45f-6e5d-41d7-b934-e2001e4813c2_dfbd363a-09c6-40cf-93ba-ec084ee57a8e.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"18,359 mg/m3",,rat "Hydrocarbons, C4, 1,3-butadiene- and isobutene-free",95465-89-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c97495b9-bbd2-4d92-9072-bbae952707c8/documents/IUC5-c3aaa45f-6e5d-41d7-b934-e2001e4813c2_dfbd363a-09c6-40cf-93ba-ec084ee57a8e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"4,589 mg/m3",adverse effect observed,rat "Hydrocarbons, C4, 1,3-butadiene- and isobutene-free",95465-89-7,"Members of the C4 low 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams in this category (CAS Numbers; 91052-98-1, 92045-23-3, 95465-89-7, 95465-90-0 and 95465-91-1) but data on the constituents (butane, isobutane and butene isomers) indicate that the acute inhalational toxicity of this category is low. The LC50 values for all substances are in excess of 10,000 ppm (22,948 mg/m3) and butane and isobutane are considered to be Generally Recognised as Safe and may be used in food products. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c97495b9-bbd2-4d92-9072-bbae952707c8/documents/IUC5-cd13b7cd-93e4-4e29-a758-cd0dc2e53f4b_dfbd363a-09c6-40cf-93ba-ec084ee57a8e.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene- and isobutene-free",95465-89-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c97495b9-bbd2-4d92-9072-bbae952707c8/documents/IUC5-cd13b7cd-93e4-4e29-a758-cd0dc2e53f4b_dfbd363a-09c6-40cf-93ba-ec084ee57a8e.html,,inhalation,LC50,"> 22,948 mg/m3",no adverse effect observed, "Gases (petroleum), refinery",68814-67-5,"Only one stream of the Other Petroleum Gases category has been tested but this and the main components of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. The mammalian toxicity effects of this category will be not driven by the content of benzene as the latter is present at levels of <0.3%, however, the category may contain carbon monoxide which could trigger classification. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e41119c5-4805-43ef-b31f-4f03b524b5da/documents/IUC5-5a55592f-8b72-4e82-bb98-63a06aaf7d45_1c204119-33d2-4773-8a10-2e070c55adff.html,,,,,, "Gases (petroleum), refinery",68814-67-5,"Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the component substances. Across species, main component gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 ¿ 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene as the latter is present at levels of <0.3%, however, the category may contain carbon monoxide and/or hydrogen sulphide which could trigger classification. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e41119c5-4805-43ef-b31f-4f03b524b5da/documents/IUC5-02176948-0c88-42d0-83b5-5edbdb9e65a5_1c204119-33d2-4773-8a10-2e070c55adff.html,,,,,, "Fuel oil, no. 6",68553-00-4," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/871db37b-0e7b-47e2-83de-31fb552bec2a/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_20a8c3af-e85c-4349-923f-51c7a40bb0cf.html,,,,,, "Fuel oil, no. 6",68553-00-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/871db37b-0e7b-47e2-83de-31fb552bec2a/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_20a8c3af-e85c-4349-923f-51c7a40bb0cf.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Fuel oil, no. 6",68553-00-4,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/871db37b-0e7b-47e2-83de-31fb552bec2a/documents/12190120-6b6e-49c5-bed7-264eab246437_20a8c3af-e85c-4349-923f-51c7a40bb0cf.html,,,,,, "Fuel oil, no. 6",68553-00-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/871db37b-0e7b-47e2-83de-31fb552bec2a/documents/12190120-6b6e-49c5-bed7-264eab246437_20a8c3af-e85c-4349-923f-51c7a40bb0cf.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Fuel oil, no. 6",68553-00-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/871db37b-0e7b-47e2-83de-31fb552bec2a/documents/12190120-6b6e-49c5-bed7-264eab246437_20a8c3af-e85c-4349-923f-51c7a40bb0cf.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fuel oil, no. 6",68553-00-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/871db37b-0e7b-47e2-83de-31fb552bec2a/documents/12190120-6b6e-49c5-bed7-264eab246437_20a8c3af-e85c-4349-923f-51c7a40bb0cf.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, Lead,7439-92-1," Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0464cff-4dfa-43ef-a4d3-e569a82803bf/documents/55240df1-e7fa-4fe8-8269-766f9e1416fc_313fd63d-ecec-4312-b4ed-c16b1c0d5f44.html,,,,,, Lead,7439-92-1, Inorganic lead compounds do not exhibit toxicity in acute toxicity tests with experimental animals. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0464cff-4dfa-43ef-a4d3-e569a82803bf/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_313fd63d-ecec-4312-b4ed-c16b1c0d5f44.html,,,,,, Lead,7439-92-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0464cff-4dfa-43ef-a4d3-e569a82803bf/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_313fd63d-ecec-4312-b4ed-c16b1c0d5f44.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Lead,7439-92-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0464cff-4dfa-43ef-a4d3-e569a82803bf/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_313fd63d-ecec-4312-b4ed-c16b1c0d5f44.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Lead,7439-92-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0464cff-4dfa-43ef-a4d3-e569a82803bf/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_313fd63d-ecec-4312-b4ed-c16b1c0d5f44.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "1,1-dichloroethylene",75-35-4,"In a 2-year drinking water study conducted with rats, the NOAEL was reported to be 9 mg/kg bw (Rampy et al. 1977, Quast et al.1983). In a 90-day inhalation study conducted with rats and mice, a LOAEC of 6.25 ppm (= 26.7 mg/m3) was observed (NTP, 2015) for local effects. Systemic effects (nephropathy or cytoplasmic alterations in the liver) started to occur as of 12.5 ppm (= 53.4 mg/m3). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aac40d8e-3d06-4386-a146-c8310a169b1f/documents/IUC5-2f09c656-600b-438c-93ab-c3dac6878a8d_e5a1e620-80a1-4681-af29-99c9bcfb1eeb.html,,,,,, "1,1-dichloroethylene",75-35-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aac40d8e-3d06-4386-a146-c8310a169b1f/documents/IUC5-2f09c656-600b-438c-93ab-c3dac6878a8d_e5a1e620-80a1-4681-af29-99c9bcfb1eeb.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,26.7 mg/m3,,rat "1,1-dichloroethylene",75-35-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aac40d8e-3d06-4386-a146-c8310a169b1f/documents/IUC5-2f09c656-600b-438c-93ab-c3dac6878a8d_e5a1e620-80a1-4681-af29-99c9bcfb1eeb.html,Chronic toxicity – systemic effects,oral,NOAEL,9 mg/kg bw/day,,rat "1,1-dichloroethylene",75-35-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aac40d8e-3d06-4386-a146-c8310a169b1f/documents/IUC5-2f09c656-600b-438c-93ab-c3dac6878a8d_e5a1e620-80a1-4681-af29-99c9bcfb1eeb.html,Repeated dose toxicity – local effects,inhalation,LOAEC,26.7 mg/m3,adverse effect observed,rat "1,1-dichloroethylene",75-35-4,"The acute toxicity of 1,1-dichloroethene is characterised by a oral LD50 value in rats of 1500 mg/kg bw and by an inhalation LC50 value in rats 28350 mg/m3. Information allowing to estimate the effect level of the dermal acute toxicity could not be retrieved. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aac40d8e-3d06-4386-a146-c8310a169b1f/documents/IUC5-83fb765d-5cf2-4cc3-99df-17347c045b2c_e5a1e620-80a1-4681-af29-99c9bcfb1eeb.html,,,,,, "1,1-dichloroethylene",75-35-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aac40d8e-3d06-4386-a146-c8310a169b1f/documents/IUC5-83fb765d-5cf2-4cc3-99df-17347c045b2c_e5a1e620-80a1-4681-af29-99c9bcfb1eeb.html,,oral,LD50,"1,500 mg/kg bw",, "1,1-dichloroethylene",75-35-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aac40d8e-3d06-4386-a146-c8310a169b1f/documents/IUC5-83fb765d-5cf2-4cc3-99df-17347c045b2c_e5a1e620-80a1-4681-af29-99c9bcfb1eeb.html,,inhalation,LC50,"28,350 mg/m3",, Potassium hydrogen sulphite,7773-03-7," A 3-generation chronic toxicity study (Til et al. 1972a) with treatment of rats (20 per sex and group) with dose levels of 0, 0.125, 0.25, 0.5, 1.0 or 2.0% Na2S2O5 administered in a 50 ppm thiamine-containing diet was identified as most reliable study for repeated dose toxicity and was defined as key study (read-across info, see `discussion`). Based on the read across concept for the group of sulfite substances, this result is also applicable to potassium hydrogen sulfite. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7cd35a86-cac5-4661-b026-6984ab49f337/documents/IUC5-2196629f-24fd-4082-ab34-0b767ddaf66f_88be8814-b08c-4c22-b678-97f467bb1eb5.html,,,,,, Potassium hydrogen sulphite,7773-03-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7cd35a86-cac5-4661-b026-6984ab49f337/documents/IUC5-2196629f-24fd-4082-ab34-0b767ddaf66f_88be8814-b08c-4c22-b678-97f467bb1eb5.html,Chronic toxicity – systemic effects,oral,NOAEL,137 mg/kg bw/day,,rat Hydrazine,302-01-2," In a sub-acute toxicity study according to OECD TG 407 hydrazine monohydrate was administered to male and female Crj:CD(SD)IGS rats by gavage at dose levels of 0, 1, 3, 10, 30 mg/kg bw/day; the NOAEL is 3 mg/kg bw/day for males and female rats (MHLW 2003). Assuming that hydrazine monohydrate contains 64 % hydrazine unhydrous the respective NOAEL is 1.92 mg/kg bw/day. There is a long term inhalation study on rats, and other animals which is reported in brief. The used concentration for rats ranged between 0.05 and 5 ppm (0.066 -6.65 mg/m³) hydrazine for 6 h per day, 5 days per week for 1 year. With respect to non-neoplastic lesions in rats the LOAEC is 0.066mg/m³ (MacEwen 1981, Vernot 1985) based on local effects at the respiratory tract.. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c2163bc-df97-4450-8dd0-556590a31baf/documents/IUC5-e0d6c14f-f807-4c6d-aeeb-24301fa8c155_03ded5c3-45b0-4687-b454-e9ffedfe450f.html,,,,,, Hydrazine,302-01-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c2163bc-df97-4450-8dd0-556590a31baf/documents/IUC5-e0d6c14f-f807-4c6d-aeeb-24301fa8c155_03ded5c3-45b0-4687-b454-e9ffedfe450f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,1.92 mg/kg bw/day,,rat Hydrazine,302-01-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c2163bc-df97-4450-8dd0-556590a31baf/documents/IUC5-e0d6c14f-f807-4c6d-aeeb-24301fa8c155_03ded5c3-45b0-4687-b454-e9ffedfe450f.html,Repeated dose toxicity – local effects,inhalation,LOAEC,0.066 mg/m3,adverse effect observed,rat Hydrazine,302-01-2," Acute oral toxicity of hydrazine monohydrate was determined in male and female rats according to OECD TG 401 and GLP (MHLW 2003). Assuming that hydrazine monohydrate solution contains 64 % hydrazine the respective results for hydrazine LD50 (rat, oral): 173 mg/kg bw for males and ranges between 108 and 141 mg/kg bw for females. Rats were exposed to 400 -800 ppm hydrazine for 4 hours and resulted in a LC50 (male rat) of 570 ppm (759 mg/m³, Jacobson 1955). Hydrazine is classified as corrosive. Thus, a dermal acute toxicity study needs not to be available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c2163bc-df97-4450-8dd0-556590a31baf/documents/IUC5-b86d7b93-da33-4376-9c6c-7fb5b90182f5_03ded5c3-45b0-4687-b454-e9ffedfe450f.html,,,,,, Hydrazine,302-01-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c2163bc-df97-4450-8dd0-556590a31baf/documents/IUC5-b86d7b93-da33-4376-9c6c-7fb5b90182f5_03ded5c3-45b0-4687-b454-e9ffedfe450f.html,,oral,LD50,108 mg/kg bw,adverse effect observed, Hydrazine,302-01-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c2163bc-df97-4450-8dd0-556590a31baf/documents/IUC5-b86d7b93-da33-4376-9c6c-7fb5b90182f5_03ded5c3-45b0-4687-b454-e9ffedfe450f.html,,inhalation,LC50,759 mg/m3,adverse effect observed, Rutile (TiO2),1317-80-2,"No reliable results are available for repeated dose toxicity of synthetic rutile. Therefore, read-across is proposed to available data on TiO2.Titanium dioxide did not show adverse effects in a chronic oral repeated dose toxicity study in rats with a NOAEL of 3500mg/kg bw/day.Titanium dioxide is not absorbed to any relevant extent through human skin, thus no toxic effects can be expected via the dermal route of exposure.Synthetic rutile is not inhalable at any relevant extent, thus conduct of repeated dose toxicity studies via the inhalation route is considered dispensable. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a811088-548f-4987-bff6-9d89c6e13303/documents/IUC5-59f2e77d-4448-4b72-a6c7-aa1da4e3d71e_7901950b-e1b1-4c44-a6f1-b63e89ba04a7.html,,,,,, Rutile (TiO2),1317-80-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a811088-548f-4987-bff6-9d89c6e13303/documents/IUC5-59f2e77d-4448-4b72-a6c7-aa1da4e3d71e_7901950b-e1b1-4c44-a6f1-b63e89ba04a7.html,Chronic toxicity – systemic effects,oral,NOAEL,"3,500 mg/kg bw/day",,rat Rutile (TiO2),1317-80-2,"No reliable results are available for acute toxicity of synthetic rutile. Therefore, read-across is proposed to available data on TiO2. Acute toxicity, oral:LD50 > 5000mg/kg bwAcute toxicity, inhalation:LC50 > 6.82mg/L (MMAD=1.55 µm, GSD=1.70 µm)Acute toxicity, dermal:Conduct of an acute dermal toxicity study is unjustified as inhalation of the substance is considered as major route of exposure and physicochemical properties and dermal absorption data of the substance do not suggest a significant rate of absorption through the skin (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a811088-548f-4987-bff6-9d89c6e13303/documents/IUC5-239b1936-f911-4dbd-9d9b-3360ce356f53_7901950b-e1b1-4c44-a6f1-b63e89ba04a7.html,,,,,, Rutile (TiO2),1317-80-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a811088-548f-4987-bff6-9d89c6e13303/documents/IUC5-239b1936-f911-4dbd-9d9b-3360ce356f53_7901950b-e1b1-4c44-a6f1-b63e89ba04a7.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Iodine,7553-56-2," Key animal data: A reliable subacute oral toxicity study in rats showed a NOAEL of 10 mg/kg bw/day of iodine for repeated dose toxicity (highest tested dose level). The study was performed according to OECD guideline 422 using rats. A subchronic toxicity study to assess the effects of iodine and iodide was conducted in male and female Sprague-Dawley rats. Animals were treated with 0, 1, 3, 10 and 100 mg/L of either iodine or iodide (as NaI) in drinking water for 100 days. A NOAEL  of 0.375 mg/kg body weight/day and a LOAEL of 1.25 mg/kg bw/day for thyroid imbalance in female rats was found (calculated from 3 and 10 mg/L in drinking water, assuming a daily consumption of 25 mL per animal and a body weight of 200 grams). Specifically, in this study, a significant increase in T4 levels in females and an increase T4/T3 ratio in both sexes at the highest iodine concentration, was seen . In the case of iodide, there was an increase in T3 levels at 10 and 100 mg/L in male rats. T4/T3 ratio was increased at the highest iodide concentration in females and decreased at 10 mg/L in males. After 100 days of treatment, T4 values were decreased and the T4/T3 ratio increased significantly at 10 and 100 mg/L in female rats, this effect was only significant at the highest concentration in male rats. With sodium iodide, results were less predictable, T4 level increased at 1 mg/mL in males and T3 levels as well as T4/T3 ratio were affected at the lowest and highest concentrations. The fact that also iodide was tested in this study has no impact on the acceptability of the study, since iodine is quickly and quantitatively reduced to iodide in the small intestine prior to absorption and then converted to iodine in the thyroid and / or excreted as iodide via the urine.   Key human data: In addition, there is an extensive set of literature on the long-term effects of iodine, iodide, and iodate salts in humans - see expert opinions below and section 7.10 for further informaiton on the key epidemiological tudies used for endpoint conclusion and dose descriptor. Based on the studies by Boyages et al., 1989 and Li et al., 1987 a chronic NOAEL in humans can be set at 0.01 mg/kg bw/day for a sensitive sub populations based on subclinical hypothyroidism in healthy human children. The same data has been used by the ATSDR and WHO as the basis for setting a mimimum risk level (ATSDR) and a Tolerable Daily Intake (WHO) of 0.01 mg/kg bw/day which are values for acceptable oral chronic exposure to iodine. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4fa13fde-4a1a-457a-8e06-5a777a899501/documents/5ea9cdaa-6d23-4874-9ad2-45ed815b49e8_9431eeb4-9a03-4761-9807-796ca70f155b.html,,,,,, Iodine,7553-56-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4fa13fde-4a1a-457a-8e06-5a777a899501/documents/5ea9cdaa-6d23-4874-9ad2-45ed815b49e8_9431eeb4-9a03-4761-9807-796ca70f155b.html,Chronic toxicity – systemic effects,oral,NOAEL,0.01 mg/kg bw/day,,other:Human data Iodine,7553-56-2, Acute oral toxicity: 315 mg/kg (rats) Acute inhalation toxicity: >4.588 mg/L air (rats) Acute dermal toxicity: 1425  mg/kg bw (rabbits) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fa13fde-4a1a-457a-8e06-5a777a899501/documents/0540d399-1679-4767-92e3-ed4849d8631b_9431eeb4-9a03-4761-9807-796ca70f155b.html,,,,,, Iodine,7553-56-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fa13fde-4a1a-457a-8e06-5a777a899501/documents/0540d399-1679-4767-92e3-ed4849d8631b_9431eeb4-9a03-4761-9807-796ca70f155b.html,,oral,LD50,315 mg/kg bw,adverse effect observed, Iodine,7553-56-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fa13fde-4a1a-457a-8e06-5a777a899501/documents/0540d399-1679-4767-92e3-ed4849d8631b_9431eeb4-9a03-4761-9807-796ca70f155b.html,,dermal,LD50,"1,425 mg/kg bw",adverse effect observed, Iodine,7553-56-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fa13fde-4a1a-457a-8e06-5a777a899501/documents/0540d399-1679-4767-92e3-ed4849d8631b_9431eeb4-9a03-4761-9807-796ca70f155b.html,,inhalation,LC50,"4,588 mg/m3",adverse effect observed, Trichloroethylene,79-01-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): good Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): good ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9d7b707-c6d0-45b7-9df4-b42adaf1d804/documents/d2d972a6-3534-4a5c-af89-380e667ad8b0_5d6c8117-9351-4d82-93dd-827a1eedbb55.html,,,,,, Trichloroethylene,79-01-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9d7b707-c6d0-45b7-9df4-b42adaf1d804/documents/d2d972a6-3534-4a5c-af89-380e667ad8b0_5d6c8117-9351-4d82-93dd-827a1eedbb55.html,Chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Trichloroethylene,79-01-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9d7b707-c6d0-45b7-9df4-b42adaf1d804/documents/d2d972a6-3534-4a5c-af89-380e667ad8b0_5d6c8117-9351-4d82-93dd-827a1eedbb55.html,Chronic toxicity – systemic effects,inhalation,NOAEC,547 mg/m3,,rat Trichloroethylene,79-01-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): good Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): good ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9d7b707-c6d0-45b7-9df4-b42adaf1d804/documents/d7e78ad5-fac3-4c79-bea9-5edae1cbdb3c_5d6c8117-9351-4d82-93dd-827a1eedbb55.html,,,,,, Trichloroethylene,79-01-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9d7b707-c6d0-45b7-9df4-b42adaf1d804/documents/d7e78ad5-fac3-4c79-bea9-5edae1cbdb3c_5d6c8117-9351-4d82-93dd-827a1eedbb55.html,,oral,LD50,"5,400 mg/kg bw",adverse effect observed, Trichloroethylene,79-01-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9d7b707-c6d0-45b7-9df4-b42adaf1d804/documents/d7e78ad5-fac3-4c79-bea9-5edae1cbdb3c_5d6c8117-9351-4d82-93dd-827a1eedbb55.html,,inhalation,LC50,"64,500 mg/m3",adverse effect observed, "1,1,2-trichloroethane",79-00-5,Key values were obtained from a chronic oral NCI study with mice (1978) and the sub-chronic inhalation study with rats (UNEP 2000). ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1185927-1e25-4de8-a5b8-b6dffc0c6534/documents/IUC5-e4c15a4c-0793-425f-b8ad-894cd10500f2_6783cd1b-4e7f-4d42-82d1-be2b2c9fe13b.html,,,,,, "1,1,2-trichloroethane",79-00-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1185927-1e25-4de8-a5b8-b6dffc0c6534/documents/IUC5-e4c15a4c-0793-425f-b8ad-894cd10500f2_6783cd1b-4e7f-4d42-82d1-be2b2c9fe13b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,mouse "1,1,2-trichloroethane",79-00-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1185927-1e25-4de8-a5b8-b6dffc0c6534/documents/IUC5-e4c15a4c-0793-425f-b8ad-894cd10500f2_6783cd1b-4e7f-4d42-82d1-be2b2c9fe13b.html,Chronic toxicity – systemic effects,inhalation,NOAEC,83 mg/m3,,rat "1,1,2-trichloroethane",79-00-5,"Acute toxicity (LD50) of 1,1,2-trichloroethane is 837 mg/kg by oral administration in rats and 9 g/m3 /6hr by inhalation in rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1185927-1e25-4de8-a5b8-b6dffc0c6534/documents/IUC5-5655d046-ac2c-42ca-a4a7-db130319b992_6783cd1b-4e7f-4d42-82d1-be2b2c9fe13b.html,,,,,, "1,1,2-trichloroethane",79-00-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1185927-1e25-4de8-a5b8-b6dffc0c6534/documents/IUC5-5655d046-ac2c-42ca-a4a7-db130319b992_6783cd1b-4e7f-4d42-82d1-be2b2c9fe13b.html,,oral,LD50,837 mg/kg bw,, "1,1,2-trichloroethane",79-00-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1185927-1e25-4de8-a5b8-b6dffc0c6534/documents/IUC5-5655d046-ac2c-42ca-a4a7-db130319b992_6783cd1b-4e7f-4d42-82d1-be2b2c9fe13b.html,,inhalation,LC50,"9,000 mg/m3",, "1,3,5-trioxane",110-88-3,In a 90 day gavage study (OECD 408) no adverse signs of toxicity were observed in rats treated in the highest tested dose level (NOAEL 300 mg/kg bw/day). In a 2 week inhalation study with rats signs of respiratory irritation were observed in all exposure group. Though no signs of systemic toxicity were observed. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4929aaf9-821e-4a7a-bc5f-346bae59098e/documents/IUC5-219dc8ad-cba0-449f-9b60-192e7c075095_dc0c3f38-734e-4b7c-b039-a3d3344e11c0.html,,,,,, "1,3,5-trioxane",110-88-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4929aaf9-821e-4a7a-bc5f-346bae59098e/documents/IUC5-219dc8ad-cba0-449f-9b60-192e7c075095_dc0c3f38-734e-4b7c-b039-a3d3344e11c0.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,3.62 mg/m3,,rat "1,3,5-trioxane",110-88-3,LD50 oral >3200 mg/kg bw (no mortalities and no severe signs of toxicity were observed up to the highest dose tested) LC50 inhal. >39.2 mg/l (no mortality and only mild signs of toxicity at maximally achievable vapor concentration)LD50 dermal >3980 mg/kg bw (no clinical symptoms of toxicity) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4929aaf9-821e-4a7a-bc5f-346bae59098e/documents/IUC5-d68eb271-9670-4bee-8ad7-52f91540ac5a_dc0c3f38-734e-4b7c-b039-a3d3344e11c0.html,,,,,, "cis-4-[3-(p-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine",67564-91-4," The 4 week short term oral toxicity of fenpropimorph is characterised by reduced body weight in rats, mice and to a lesser extent in dogs. At high dose levels (1600 ppm) in rats clinical signs of toxicity were observed, in mice dosed 4000 ppm clinical signs of toxicity as well as mortality was noted. Dogs dosed up to 1600 ppm did not demonstrate clinical signs of toxicity. Haematological examinations revealed reduced haemoglobin and increased bilirubin in rats only. Clinical-chemical parameters such as cholesterol, triglycerides, total protein, calcium and glucose were decreased in high dose rats. Increased liver weights were observed in rats, mice and dogs. A histopathological correlate was not detected, suggesting an adaptive effect. The 90 day oral toxicity studies, performed in rats and dogs revealed reduced body weights in high dose rats but not in dogs. Haematology demonstrated decreased haemoglobin and increased bilirubin, just as in the 4 weeks study, in high dose rats. In both species alanine aminotransferase was increased. Also similar to the 4 week rat study, triglycerides and cholesterol were decreased in the high dose rats of the 90 day study. In the 90 day feeding studies, liver weight was found to be increased in rats. Similar to the 4 week studies, a histopathological correlate was not observed. In the two 90 day rat studies the NOAELs for systemic toxicity, excluding cholinesterase reduction (see below), were 10 ppm (0.7 / 0.8 mg/kg bw/d for males and females) and 12.5 ppm (0.78 / 0.93 mg/kg bw/d). As the next higher dose level was 100 ppm, the NOAEL of 12.5 ppm can be used as an overall NOAEL for systemic toxicity, excluding cholinesterase reduction. The determination of plasma/serum-, erythrocyte- and brain cholinesterase in the short-term studies showed that only serum/plasma cholinesterase was reduced and exclusively in rats. The overall NOAEL for cholinesterase reduction was 0.39 mg/kg bw/d (males) and 0.47 mg/kg bw/d (females). In the 4 week inhalation study in rats there were no effects on body weight, but several clinical chemical parameters were altered; e.g. increased alanine aminotransferase and alkaline phosphatase as well as decreased cholesterol. These changes have also been observed in the oral studies in rats. Plasma cholinesterase activity was reduced in the high and mid dose level. The NOAEL was determined to be 0.01 mg/l (2.5 mg/kg bw/d – males, 3.4 mg/kg bw/d – females). In a 4-week dermal study in Wistar rats the NOAEL for systemic toxicity was 2.0 mg/kg bw/d (0.05 % concentration), the highest dose applied in this study. Signs of local irritation were not observed. The selection of the concentrations was based on the results of a pretest in which significant dermal changes (scale formation) were observed at a concentration of 0.1 %. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9747ff0e-2fd7-4c00-ab3f-07eb917fd284/documents/6f90a8ef-975f-4607-8e43-ac4fb08f9b75_486220a2-ff94-4b3b-94b3-4a7e03020e86.html,,,,,, "cis-4-[3-(p-tert-butylphenyl)-2-methylpropyl]-2,6-dimethylmorpholine",67564-91-4," Fenpropimorph is harmful after oral administration, but will not be absorbed through the skin in toxic doses after a single exposure (LD 50 > 5000 mg/kg bw). LC 50 values after acute inhalation exposure range between 2.9 and 9.1 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9747ff0e-2fd7-4c00-ab3f-07eb917fd284/documents/0eccd390-696c-40c2-b69f-35c6ea9ca1fe_486220a2-ff94-4b3b-94b3-4a7e03020e86.html,,,,,, "1,4-dichlorobenzene",106-46-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c3b0313-9ca0-4b70-a391-20fad2d5937a/documents/IUC5-5093811d-6cc8-4853-8db2-f36796df95f1_a048da27-dcb7-467d-b055-defe788c5a43.html,Chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,dog "1,4-dichlorobenzene",106-46-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c3b0313-9ca0-4b70-a391-20fad2d5937a/documents/IUC5-5093811d-6cc8-4853-8db2-f36796df95f1_a048da27-dcb7-467d-b055-defe788c5a43.html,Chronic toxicity – systemic effects,inhalation,NOAEC,450 mg/m3,,rat "1,4-dichlorobenzene",106-46-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c3b0313-9ca0-4b70-a391-20fad2d5937a/documents/IUC5-5093811d-6cc8-4853-8db2-f36796df95f1_a048da27-dcb7-467d-b055-defe788c5a43.html,Repeated dose toxicity – local effects,inhalation,NOAEC,450 mg/m3,adverse effect observed,rat "1,4-dichlorobenzene",106-46-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c3b0313-9ca0-4b70-a391-20fad2d5937a/documents/IUC5-294dba25-7047-4752-b56f-0afc4d29cbb2_a048da27-dcb7-467d-b055-defe788c5a43.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,4-dichlorobenzene",106-46-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c3b0313-9ca0-4b70-a391-20fad2d5937a/documents/IUC5-294dba25-7047-4752-b56f-0afc4d29cbb2_a048da27-dcb7-467d-b055-defe788c5a43.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,4-dichlorobenzene",106-46-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c3b0313-9ca0-4b70-a391-20fad2d5937a/documents/IUC5-294dba25-7047-4752-b56f-0afc4d29cbb2_a048da27-dcb7-467d-b055-defe788c5a43.html,,inhalation,discriminating conc.,"5,000 mg/m3",no adverse effect observed, "5,5'-diisopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite",552-22-7," The acute oral LD50, to female Wistar Han rats, was determined to be in excess of 2000 mg/kg bw, the highest dose level tested. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35e514dd-eb3f-4fc1-8db3-224447299437/documents/abb69006-585d-48f7-83d4-e80dafa7376c_5d0f3288-7065-4225-a285-581fd13a74f9.html,,,,,, "5,5'-diisopropyl-2,2'-dimethylbiphenyl-4,4'-diyl dihypoiodite",552-22-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35e514dd-eb3f-4fc1-8db3-224447299437/documents/abb69006-585d-48f7-83d4-e80dafa7376c_5d0f3288-7065-4225-a285-581fd13a74f9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-chloro-4-nitrobenzene,100-00-5,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b4c49d0-abf1-4343-a108-bdd0b9f33a47/documents/8ea6514e-0099-4ee6-9344-850463a56c66_9297ad9b-0373-422b-9922-4f5677bc18b3.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,3 mg/kg bw/day,, 1-chloro-4-nitrobenzene,100-00-5,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b4c49d0-abf1-4343-a108-bdd0b9f33a47/documents/8ea6514e-0099-4ee6-9344-850463a56c66_9297ad9b-0373-422b-9922-4f5677bc18b3.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,9.81 mg/m3,, 1-chloro-4-nitrobenzene,100-00-5,"P-chloronitrobenzene was found to be harmful if swallowed, in contact with skin and by inhalation. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b4c49d0-abf1-4343-a108-bdd0b9f33a47/documents/7f9c4e2d-f124-4087-8142-9b368a37bd76_9297ad9b-0373-422b-9922-4f5677bc18b3.html,,,,,, 1-chloro-4-nitrobenzene,100-00-5,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b4c49d0-abf1-4343-a108-bdd0b9f33a47/documents/7f9c4e2d-f124-4087-8142-9b368a37bd76_9297ad9b-0373-422b-9922-4f5677bc18b3.html,,oral,LD50,294 mg/kg bw,adverse effect observed, 1-chloro-4-nitrobenzene,100-00-5,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b4c49d0-abf1-4343-a108-bdd0b9f33a47/documents/7f9c4e2d-f124-4087-8142-9b368a37bd76_9297ad9b-0373-422b-9922-4f5677bc18b3.html,,dermal,LD50,750 mg/kg bw,adverse effect observed, 1-chloro-4-nitrobenzene,100-00-5,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b4c49d0-abf1-4343-a108-bdd0b9f33a47/documents/7f9c4e2d-f124-4087-8142-9b368a37bd76_9297ad9b-0373-422b-9922-4f5677bc18b3.html,,inhalation,discriminating conc.,"16,100 mg/m3",adverse effect observed, 2-nitropropane,79-46-9,One key acute rat oral study and one supporting acute rabbit oral study was identified. One key acute rabbit dermal study was identified for this compound. One key acute rat inhalation study was identified. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/006ff312-43e7-4b12-87f5-03a177e069aa/documents/IUC5-bd1e4142-24b4-4240-9a11-e15dc423a19b_3afcb204-83c6-47b3-b02f-802adad95ce3.html,,,,,, 2-nitropropane,79-46-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/006ff312-43e7-4b12-87f5-03a177e069aa/documents/IUC5-bd1e4142-24b4-4240-9a11-e15dc423a19b_3afcb204-83c6-47b3-b02f-802adad95ce3.html,,oral,LD50,725 mg/kg bw,, 2-nitropropane,79-46-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/006ff312-43e7-4b12-87f5-03a177e069aa/documents/IUC5-bd1e4142-24b4-4240-9a11-e15dc423a19b_3afcb204-83c6-47b3-b02f-802adad95ce3.html,,dermal,LD50,"2,000 mg/kg bw",, 2-nitropropane,79-46-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/006ff312-43e7-4b12-87f5-03a177e069aa/documents/IUC5-bd1e4142-24b4-4240-9a11-e15dc423a19b_3afcb204-83c6-47b3-b02f-802adad95ce3.html,,inhalation,LC50,"2,186 mg/m3",, "Residues (petroleum), alkylation splitter, C4-rich",68513-66-6,"Only one stream (Liquified Petroleum Gases CAS 68476 -85 -7) of the Other Petroleum Gases category has been tested but this and the main constituents of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and humans. The mammalian toxicity effects of this category will be driven by the content of benzene if the latter is present at levels of >10%. Additionally, the category may contain carbon monoxide which could trigger classification.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd5613b1-1b9c-41ad-9619-03a7bab8bf05/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_721fab17-d703-4e80-9038-a7b46e409369.html,,,,,, "Residues (petroleum), alkylation splitter, C4-rich",68513-66-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd5613b1-1b9c-41ad-9619-03a7bab8bf05/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_721fab17-d703-4e80-9038-a7b46e409369.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"7,214 mg/m3",,rat "Residues (petroleum), alkylation splitter, C4-rich",68513-66-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd5613b1-1b9c-41ad-9619-03a7bab8bf05/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_721fab17-d703-4e80-9038-a7b46e409369.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"8,600 mg/m3",adverse effect observed,rat "Residues (petroleum), alkylation splitter, C4-rich",68513-66-6,"Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the constituents. Across species, main constituent gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene in streams where it is present at levels of <1%. However, some streams in this category may contain benzene levels >1% or carbon monoxide which could trigger classification. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd5613b1-1b9c-41ad-9619-03a7bab8bf05/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_721fab17-d703-4e80-9038-a7b46e409369.html,,,,,, "Residues (petroleum), alkylation splitter, C4-rich",68513-66-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd5613b1-1b9c-41ad-9619-03a7bab8bf05/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_721fab17-d703-4e80-9038-a7b46e409369.html,,inhalation,LC50,"22,948 mg/m3",no adverse effect observed, "Gases (petroleum), deisobutanizer tower overheads",68477-87-2,"Only one stream (Liquified Petroleum Gases CAS 68476 -85 -7) of the Other Petroleum Gases category has been tested but this and the main constituents of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and humans. The mammalian toxicity effects of this category will be driven by the content of benzene if the latter is present at levels of >10%. Additionally, the category may contain carbon monoxide which could trigger classification.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b7f3ce4-0b50-4e92-8f2e-640709ff0148/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_28c63eb3-d369-438a-a2d4-3d87cc03fa0d.html,,,,,, "Gases (petroleum), deisobutanizer tower overheads",68477-87-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b7f3ce4-0b50-4e92-8f2e-640709ff0148/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_28c63eb3-d369-438a-a2d4-3d87cc03fa0d.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"7,214 mg/m3",,rat "Gases (petroleum), deisobutanizer tower overheads",68477-87-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b7f3ce4-0b50-4e92-8f2e-640709ff0148/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_28c63eb3-d369-438a-a2d4-3d87cc03fa0d.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"8,600 mg/m3",adverse effect observed,rat "Gases (petroleum), deisobutanizer tower overheads",68477-87-2,"Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the constituents. Across species, main constituent gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene in streams where it is present at levels of <1%. However, some streams in this category may contain benzene levels >1% or carbon monoxide which could trigger classification. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b7f3ce4-0b50-4e92-8f2e-640709ff0148/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_28c63eb3-d369-438a-a2d4-3d87cc03fa0d.html,,,,,, "Gases (petroleum), deisobutanizer tower overheads",68477-87-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b7f3ce4-0b50-4e92-8f2e-640709ff0148/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_28c63eb3-d369-438a-a2d4-3d87cc03fa0d.html,,inhalation,LC50,"22,948 mg/m3",no adverse effect observed, Cobalt sulphate,10124-43-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): key study available ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9fb51d9-e358-45c5-b7ee-f5b48a74c101/documents/342bd78e-2da5-47fd-ba3b-79c80e47db95_1f9fafc9-a8ac-4b20-ae34-1aa772e0c77e.html,,,,,, Cobalt sulphate,10124-43-3,"Acute oral toxicity:LD50(rat)= 768 mg cobalt sulfate heptahydrate/kg bwAcute dermal toxicity:Conduct of an acute dermal toxicity study for cobalt sulfate is unjustified since dermal uptake is considered negligible.Acute inhalation toxicity:Conduct of an acute inhalation toxicity study is technically not feasible, since a stable inhalation atmosphere cannot be generated with cobalt sulfate. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9fb51d9-e358-45c5-b7ee-f5b48a74c101/documents/IUC5-ddae71cd-94de-4f89-85f9-724e9de35159_1f9fafc9-a8ac-4b20-ae34-1aa772e0c77e.html,,,,,, Cobalt sulphate,10124-43-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9fb51d9-e358-45c5-b7ee-f5b48a74c101/documents/IUC5-ddae71cd-94de-4f89-85f9-724e9de35159_1f9fafc9-a8ac-4b20-ae34-1aa772e0c77e.html,,oral,LD50,768 mg/kg bw,adverse effect observed, "Extracts (petroleum), heavy naphthenic distillate solvent",64742-11-6,"NOAEL for heavy paraffinic distillate aromatic extract could not be identified in a 90-day oral study (equivalent to OECD 408) and is less than 125 mg/kg/day when administered orally to male rats.  Systemic toxicity was observed in a 90-day dermal study (equivalent to OECD 411) in rats exposed to heavy paraffinic DAE (CAS number 64742-04-7).  A NOAEL could not be established since toxicity was observed at all dosing levels, including the lowest dose tested. The authors considered the NOAEL for dermal exposure to be less than 30 mg/kg/day.  In a 28-day dermal study (equivalent to OECD 410), no signs of systemic toxicity were observed in rabbits even at the high dose, 1000 mg/kg/day.   ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/99f445c0-d93a-4000-b6b6-926903d88f62/documents/7bbda247-3440-4298-a989-84c2d1a494ff_5e2f9547-d7b1-4007-ac18-028c38276234.html,,,,,, "Extracts (petroleum), heavy naphthenic distillate solvent",64742-11-6,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/99f445c0-d93a-4000-b6b6-926903d88f62/documents/7bbda247-3440-4298-a989-84c2d1a494ff_5e2f9547-d7b1-4007-ac18-028c38276234.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Extracts (petroleum), heavy naphthenic distillate solvent",64742-11-6,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/99f445c0-d93a-4000-b6b6-926903d88f62/documents/7bbda247-3440-4298-a989-84c2d1a494ff_5e2f9547-d7b1-4007-ac18-028c38276234.html,Sub-chronic toxicity – systemic effects,dermal,LOAEL,30 mg/kg bw/day,,rat "Extracts (petroleum), heavy naphthenic distillate solvent",64742-11-6,"Key acute oral (similar to OECD 401), dermal (similar to OECD 402), and inhalation (OECD 403)  toxicity studies (OECD 420) were identified.• The oral LD50 was > 5000 mg/kg bw in male and female rats for light paraffinic DAE.• The inhalation LC50 was > 5 mg/L for DAE.• The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for light paraffinic DAE. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99f445c0-d93a-4000-b6b6-926903d88f62/documents/49623972-9bec-41a1-849e-1214cef6d1d9_5e2f9547-d7b1-4007-ac18-028c38276234.html,,,,,, "Extracts (petroleum), heavy naphthenic distillate solvent",64742-11-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99f445c0-d93a-4000-b6b6-926903d88f62/documents/49623972-9bec-41a1-849e-1214cef6d1d9_5e2f9547-d7b1-4007-ac18-028c38276234.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Extracts (petroleum), heavy naphthenic distillate solvent",64742-11-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99f445c0-d93a-4000-b6b6-926903d88f62/documents/49623972-9bec-41a1-849e-1214cef6d1d9_5e2f9547-d7b1-4007-ac18-028c38276234.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Extracts (petroleum), heavy naphthenic distillate solvent",64742-11-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99f445c0-d93a-4000-b6b6-926903d88f62/documents/49623972-9bec-41a1-849e-1214cef6d1d9_5e2f9547-d7b1-4007-ac18-028c38276234.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Distillates (petroleum), light naphthenic",64741-52-2,"In a read-across 90-day oral study (equivalent to OECD 408) from distillate aromatic extract, a NOAEL could not be identified and is less than 125 mg/kg/day to male rats. In a read-across subacute inhalation study (non-guideline) from other lubricant base oils (IP 346 < 3%), the NOAEC for pulmonary effects was 500 mg/m3, and the NOAEC for systemic effects resulting from inhalation exposure was =1500 mg/m3 in rats. One key 28-day dermal study (OECD 410) was identified, along with one read-across 90-day dermal study (OECD 411) from distillate aromatic extract. For the 28-day dermal study, the systemic NOAEL in this study is 1000 mg/kg/day for rabbits dosed with 0, 200, 1000, or 2000 mg/kg/day. The dermal NOAEL is <200 mg/kg/day based on the irritation at the treatment site. For the 90-day dermal read-across study conducted with rats at dose levels of 30, 125, 500, or 1250 mg/kg/day, the LOAEL is 30 mg/kg/day, based on body weight, clinical chemistry, organ weights, gross pathology, and histopathology. A NOAEL is not identified. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ed2ce6a-7d1f-4b3a-b86c-05dc8a3e0fb4/documents/IUC5-a814c02a-c517-4c10-b49b-f3436f9e5f7e_bc6e8596-5ab0-41ab-bd03-d05bf8d70d5a.html,,,,,, "Distillates (petroleum), light naphthenic",64741-52-2,Key acute oral (OECD 401) and dermal (OECD 402) studies were identified for unrefined acid treated oils. A read-across acute toxicity for inhalation (OECD 403) was identified from distillate aromatic extracts. LD50 and LC50 values were as follows:• The oral LD50 was > 5000 mg/kg bw in male and female rats exposed to unrefined/acid treated oils.• The dermal LD50 was > 2000 mg/kg bw in male and female rabbits exposed to unrefined/acid treated oils.• The LC50 was >5 mg/L (equivalent to 5000 mg/m3) in male and female rats exposed to distillate aromatic extracts. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ed2ce6a-7d1f-4b3a-b86c-05dc8a3e0fb4/documents/IUC5-84b68e58-345b-49ea-ab24-424d7304bb51_bc6e8596-5ab0-41ab-bd03-d05bf8d70d5a.html,,,,,, "Distillates (petroleum), light naphthenic",64741-52-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ed2ce6a-7d1f-4b3a-b86c-05dc8a3e0fb4/documents/IUC5-84b68e58-345b-49ea-ab24-424d7304bb51_bc6e8596-5ab0-41ab-bd03-d05bf8d70d5a.html,,oral,LD50,"5,000 mg/kg bw",, "Distillates (petroleum), light naphthenic",64741-52-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ed2ce6a-7d1f-4b3a-b86c-05dc8a3e0fb4/documents/IUC5-84b68e58-345b-49ea-ab24-424d7304bb51_bc6e8596-5ab0-41ab-bd03-d05bf8d70d5a.html,,dermal,LD50,"2,000 mg/kg bw",, "Distillates (petroleum), light naphthenic",64741-52-2,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ed2ce6a-7d1f-4b3a-b86c-05dc8a3e0fb4/documents/IUC5-84b68e58-345b-49ea-ab24-424d7304bb51_bc6e8596-5ab0-41ab-bd03-d05bf8d70d5a.html,,inhalation,LC50,"5,000 mg/m3",, "Hydrocarbons, C3-4",68476-40-4,"Only one stream (Liquified Petroleum Gases CAS 68476 -85 -7) of the Other Petroleum Gases category has been tested but this and the main constituents of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and humans. The mammalian toxicity effects of this category will be driven by the content of benzene if the latter is present at levels of >10%. Additionally, the category may contain carbon monoxide which could trigger classification.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e994465-f3eb-4be2-b948-b3c87f1d2264/documents/4da54c6d-f0e6-4ff7-8efd-be4c8ce32471_e13b693b-acc1-4c5e-b59e-dda2789500ed.html,,,,,, "Hydrocarbons, C3-4",68476-40-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e994465-f3eb-4be2-b948-b3c87f1d2264/documents/4da54c6d-f0e6-4ff7-8efd-be4c8ce32471_e13b693b-acc1-4c5e-b59e-dda2789500ed.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"7,214 mg/m3",,rat "Hydrocarbons, C3-4",68476-40-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e994465-f3eb-4be2-b948-b3c87f1d2264/documents/4da54c6d-f0e6-4ff7-8efd-be4c8ce32471_e13b693b-acc1-4c5e-b59e-dda2789500ed.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"8,600 mg/m3",adverse effect observed,rat "Hydrocarbons, C3-4",68476-40-4,"Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the constituents. Across species, main constituent gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene in streams where it is present at levels of <1%. However, some streams in this category may contain benzene levels >1% or carbon monoxide which could trigger classification. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e994465-f3eb-4be2-b948-b3c87f1d2264/documents/289266af-11e7-4dbf-9988-b1d60b89ab62_e13b693b-acc1-4c5e-b59e-dda2789500ed.html,,,,,, "Hydrocarbons, C3-4",68476-40-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e994465-f3eb-4be2-b948-b3c87f1d2264/documents/289266af-11e7-4dbf-9988-b1d60b89ab62_e13b693b-acc1-4c5e-b59e-dda2789500ed.html,,inhalation,LC50,"22,948 mg/m3",no adverse effect observed, 2-nitrotoluene,88-72-2,Rat sub-chronic oral NOAEL = 45 mg/kg bw/day. Rat chronic oral LOAEL = 25 mg/kg bw/day. Mice chronic oral LOAEL = 30 mg/kg bw/day. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/213b355a-4d53-477a-9fa3-7ff59ada0062/documents/c0c23658-d72b-4da7-9765-4e668cf9c2e2_fe6c34b2-c410-476e-bf36-76fe8574dea9.html,,,,,, 2-nitrotoluene,88-72-2,The oral LD50 value ranged from 890 to 2546 mg/kg b.w. in rats ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/213b355a-4d53-477a-9fa3-7ff59ada0062/documents/34e014c4-a19e-432f-af8f-c949ec242733_fe6c34b2-c410-476e-bf36-76fe8574dea9.html,,,,,, 2-nitrotoluene,88-72-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/213b355a-4d53-477a-9fa3-7ff59ada0062/documents/34e014c4-a19e-432f-af8f-c949ec242733_fe6c34b2-c410-476e-bf36-76fe8574dea9.html,,oral,LD50,890 mg/kg bw,adverse effect observed, "Fuel oil, no. 2",68476-30-2," There are seven oral sub-acute repeated dose oral studies conducted according to OECD TG 422. In sub-acute oral studies on CAS Numbers 64741-77-1, 68476-34-6, 68476-30-2 and 68334 -30 -5, there were no treatment-related adverse effects on systemic toxicity parameters up to and including the highest doses tested (1000 mg/kg/day for 68334 -30 -5 and 750 mg/kg/day for the remaining CAS numbers) and accordingly the NOAELs were set at these levels. In a sub-acute oral study on CAS 68476 -31 -3 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 750 mg/kg/day for males and 100 mg/kg/day for females.   In a sub-acute oral study on CAS 64741 -49 -7 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 750 mg/kg/day for males and 300 mg/kg/day for females. In a sub-acute oral study on CAS 68476 -31 -3 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 300 mg/kg/day for males and females. Supporting information is available, with two studies conducted on petroleum substances in other categories; a sub-chronic study on a Kerosine (CAS 8008-20-6) and a chronic study on a Highly Refined Base Oil (CAS 8042-47-5). These do not contain significant amounts of the PAH constituents considered to be the drivers of toxicological hazard for VHGO, but have other constituents in common. They help to demonstrate that no significant toxicological hazard is expected from other aliphatic (paraffinic and naphthenic) and aromatic (mono- and di- aromatic) constituents.   In addition, one oral sub-chronic study is proposed on a VHGO substance containing high levels of PAH constituents.   For sub-chronic inhalation toxicity of VGOs/HGOs/Distillate fuels, a conservative sub-chronic NOAEC of 750 mg/m3 was determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of >1710 mg/m3 was established for systemic effects, based on no significant findings at this level (OECD 413).   In a subacute dermal repeated-dose toxicity test, the NOEL level based on dermal irritation was 0.0001 mL/kg and a NOEL of 0.5 mL/kg was calculated for systemic toxicity (OECD 410). For subchronic dermal toxicity, a NOAEL of 30 mg/kg body weight/day appears appropriate for VGOs/HGOs/Distillate fuels based on changes in haematological parameters (decreased RBC, haemoglobin, HCT), clinical chemistry values (increased urea nitrogen and cholesterol) parameters and organ weight effects (increased liver weight, decreased thymus weight). The NOAEL for local effects is 125 mg/kg body weight/d, based on histopathological changes present at the application site (OECD 411). In addition, a recent study to OECD 411 and GLP was conducted on a member of the VHGO category. This showed low systemic toxicity (NOAEL 600 mg/kg/day), with higher doses not possible due to excessive local irritation. This study was conducted on a substance in the category low in PAH content (the constituent expected to drive toxicological hazard). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9d71dee-ad68-43e5-91d2-27242bea8960/documents/246ae508-16eb-446c-afd1-ad680080afdb_6478cab2-20ad-46d9-8ce5-ac1a147ecc2a.html,,,,,, "Fuel oil, no. 2",68476-30-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9d71dee-ad68-43e5-91d2-27242bea8960/documents/246ae508-16eb-446c-afd1-ad680080afdb_6478cab2-20ad-46d9-8ce5-ac1a147ecc2a.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,30 mg/kg bw/day,,rat "Fuel oil, no. 2",68476-30-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9d71dee-ad68-43e5-91d2-27242bea8960/documents/246ae508-16eb-446c-afd1-ad680080afdb_6478cab2-20ad-46d9-8ce5-ac1a147ecc2a.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Fuel oil, no. 2",68476-30-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9d71dee-ad68-43e5-91d2-27242bea8960/documents/246ae508-16eb-446c-afd1-ad680080afdb_6478cab2-20ad-46d9-8ce5-ac1a147ecc2a.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Fuel oil, no. 2",68476-30-2," Acute Oral Toxicity: Acute oral toxicity of #2 home heating oil, was evaluated in male and female rats following a single oral gavage administration of the test material at different concentrations (similar to OECD 401).  The  LD50 for #2 home heating oil is 21.1 mL/kg body weight (approx 17,900 mg/kg). Based on all acute oral toxicity studies, the LD50 for VGOs/HGOs/Distillate fuels is > 5000 mg/kg bw. Acute Inhalation Toxicity: Acute inhalation toxicity of naval distillate in male and female rats was evaluated in a study involving whole-body exposure  for 4 hours (similar to OECD 403).  The acute inhalation LC50 was 4.1 mg/L . Acute Dermal Toxicity: In an acute dermal toxicity study, male and female New Zealand White rabbits were exposed to #2 home heating oil for 24 hours at a dose level of 5 mL/kg (approx 4300 mg/kg). The animals were then observed for 14 days (similar to OECD 402).  Based on this study, the acute dermal LD50 is > 4300 mg/kg.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9d71dee-ad68-43e5-91d2-27242bea8960/documents/50ca8717-e805-460b-bb99-b647882e2c88_6478cab2-20ad-46d9-8ce5-ac1a147ecc2a.html,,,,,, "Fuel oil, no. 2",68476-30-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9d71dee-ad68-43e5-91d2-27242bea8960/documents/50ca8717-e805-460b-bb99-b647882e2c88_6478cab2-20ad-46d9-8ce5-ac1a147ecc2a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Fuel oil, no. 2",68476-30-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9d71dee-ad68-43e5-91d2-27242bea8960/documents/50ca8717-e805-460b-bb99-b647882e2c88_6478cab2-20ad-46d9-8ce5-ac1a147ecc2a.html,,dermal,LD50,"4,300 mg/kg bw",no adverse effect observed, "Fuel oil, no. 2",68476-30-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9d71dee-ad68-43e5-91d2-27242bea8960/documents/50ca8717-e805-460b-bb99-b647882e2c88_6478cab2-20ad-46d9-8ce5-ac1a147ecc2a.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "Residues (petroleum), catalytic reformer fractionator",64741-67-9," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7a75a66-047b-40a8-8952-1ee868d08a18/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_f61c643c-fdff-488b-8f7c-19db9861b00f.html,,,,,, "Residues (petroleum), catalytic reformer fractionator",64741-67-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7a75a66-047b-40a8-8952-1ee868d08a18/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_f61c643c-fdff-488b-8f7c-19db9861b00f.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Residues (petroleum), catalytic reformer fractionator",64741-67-9,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7a75a66-047b-40a8-8952-1ee868d08a18/documents/12190120-6b6e-49c5-bed7-264eab246437_f61c643c-fdff-488b-8f7c-19db9861b00f.html,,,,,, "Residues (petroleum), catalytic reformer fractionator",64741-67-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7a75a66-047b-40a8-8952-1ee868d08a18/documents/12190120-6b6e-49c5-bed7-264eab246437_f61c643c-fdff-488b-8f7c-19db9861b00f.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Residues (petroleum), catalytic reformer fractionator",64741-67-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7a75a66-047b-40a8-8952-1ee868d08a18/documents/12190120-6b6e-49c5-bed7-264eab246437_f61c643c-fdff-488b-8f7c-19db9861b00f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), catalytic reformer fractionator",64741-67-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7a75a66-047b-40a8-8952-1ee868d08a18/documents/12190120-6b6e-49c5-bed7-264eab246437_f61c643c-fdff-488b-8f7c-19db9861b00f.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, Residual oils (petroleum),93821-66-0," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/369ef7d6-a257-4c54-96ec-0e0e6d7e3f9c/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_c0c7865a-b468-4403-8fcb-80aafc0ff425.html,,,,,, Residual oils (petroleum),93821-66-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/369ef7d6-a257-4c54-96ec-0e0e6d7e3f9c/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_c0c7865a-b468-4403-8fcb-80aafc0ff425.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat Residual oils (petroleum),93821-66-0,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/369ef7d6-a257-4c54-96ec-0e0e6d7e3f9c/documents/12190120-6b6e-49c5-bed7-264eab246437_c0c7865a-b468-4403-8fcb-80aafc0ff425.html,,,,,, Residual oils (petroleum),93821-66-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/369ef7d6-a257-4c54-96ec-0e0e6d7e3f9c/documents/12190120-6b6e-49c5-bed7-264eab246437_c0c7865a-b468-4403-8fcb-80aafc0ff425.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, Residual oils (petroleum),93821-66-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/369ef7d6-a257-4c54-96ec-0e0e6d7e3f9c/documents/12190120-6b6e-49c5-bed7-264eab246437_c0c7865a-b468-4403-8fcb-80aafc0ff425.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Residual oils (petroleum),93821-66-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/369ef7d6-a257-4c54-96ec-0e0e6d7e3f9c/documents/12190120-6b6e-49c5-bed7-264eab246437_c0c7865a-b468-4403-8fcb-80aafc0ff425.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "Petrolatum (petroleum), clay-treated",100684-33-1,"Data available on similar materials are sufficient to adequately characterize the repeated oral toxicity and the repeated dermal toxicity of insufficiently refined petrolatum and sufficiently refined petrolatum. The data are consistent in that they demonstrate minimal effects in rats and rabbits with the exception of minimal to moderate skin irritation following repeated dermal exposures and histopathological changes with questionable relevance to humans following repeated oral exposures. Potential exposures by inhalation are expected to be low due to the low vapour pressures of petrolatum. Accordingly, it does not seem likely that there is any potential for petrolatum to produce repeated dose toxicity by an inhalation route. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/417fe9b3-b64d-401c-9c13-d15ad0d38690/documents/41098277-a189-417c-b267-9953f928d6b5_eb036db1-e4f5-4577-93e9-258d48be9577.html,,,,,, "Petrolatum (petroleum), clay-treated",100684-33-1,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/417fe9b3-b64d-401c-9c13-d15ad0d38690/documents/41098277-a189-417c-b267-9953f928d6b5_eb036db1-e4f5-4577-93e9-258d48be9577.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Petrolatum (petroleum), clay-treated",100684-33-1,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/417fe9b3-b64d-401c-9c13-d15ad0d38690/documents/41098277-a189-417c-b267-9953f928d6b5_eb036db1-e4f5-4577-93e9-258d48be9577.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Petrolatum (petroleum), clay-treated",100684-33-1,The acute toxicity of petrolatum (carcinogenic or unknown feed-stock and non-carcinogenic feed-stock) is low with no observed mortalities from oral or dermal applications. ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/417fe9b3-b64d-401c-9c13-d15ad0d38690/documents/487cb143-84ad-42d7-9af4-e03f57e30851_eb036db1-e4f5-4577-93e9-258d48be9577.html,,,,,, "Petrolatum (petroleum), clay-treated",100684-33-1,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/417fe9b3-b64d-401c-9c13-d15ad0d38690/documents/487cb143-84ad-42d7-9af4-e03f57e30851_eb036db1-e4f5-4577-93e9-258d48be9577.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Petrolatum (petroleum), clay-treated",100684-33-1,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/417fe9b3-b64d-401c-9c13-d15ad0d38690/documents/487cb143-84ad-42d7-9af4-e03f57e30851_eb036db1-e4f5-4577-93e9-258d48be9577.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fuels, diesel",68334-30-5," There are seven oral sub-acute repeated dose oral studies conducted according to OECD TG 422. In sub-acute oral studies on CAS Numbers 64741-77-1, 68476-34-6, 68476-30-2 and 68334 -30 -5, there were no treatment-related adverse effects on systemic toxicity parameters up to and including the highest doses tested (1000 mg/kg/day for 68334 -30 -5 and 750 mg/kg/day for the remaining CAS numbers) and accordingly the NOAELs were set at these levels. In a sub-acute oral study on CAS 68476 -31 -3 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 750 mg/kg/day for males and 100 mg/kg/day for females.   In a sub-acute oral study on CAS 64741 -49 -7 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 750 mg/kg/day for males and 300 mg/kg/day for females. In a sub-acute oral study on CAS 68476 -31 -3 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 300 mg/kg/day for males and females. Supporting information is available, with two studies conducted on petroleum substances in other categories; a sub-chronic study on a Kerosine (CAS 8008-20-6) and a chronic study on a Highly Refined Base Oil (CAS 8042-47-5). These do not contain significant amounts of the PAH constituents considered to be the drivers of toxicological hazard for VHGO, but have other constituents in common. They help to demonstrate that no significant toxicological hazard is expected from other aliphatic (paraffinic and naphthenic) and aromatic (mono- and di- aromatic) constituents.   In addition, one oral sub-chronic study is proposed on a VHGO substance containing high levels of PAH constituents.   For sub-chronic inhalation toxicity of VGOs/HGOs/Distillate fuels, a conservative sub-chronic NOAEC of 750 mg/m3 was determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of >1710 mg/m3 was established for systemic effects, based on no significant findings at this level (OECD 413).   In a subacute dermal repeated-dose toxicity test, the NOEL level based on dermal irritation was 0.0001 mL/kg and a NOEL of 0.5 mL/kg was calculated for systemic toxicity (OECD 410). For subchronic dermal toxicity, a NOAEL of 30 mg/kg body weight/day appears appropriate for VGOs/HGOs/Distillate fuels based on changes in haematological parameters (decreased RBC, haemoglobin, HCT), clinical chemistry values (increased urea nitrogen and cholesterol) parameters and organ weight effects (increased liver weight, decreased thymus weight). The NOAEL for local effects is 125 mg/kg body weight/d, based on histopathological changes present at the application site (OECD 411). In addition, a recent study to OECD 411 and GLP was conducted on a member of the VHGO category. This showed low systemic toxicity (NOAEL 600 mg/kg/day), with higher doses not possible due to excessive local irritation. This study was conducted on a substance in the category low in PAH content (the constituent expected to drive toxicological hazard). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9d12b08-0733-472e-be2d-7e26bfa332e9/documents/246ae508-16eb-446c-afd1-ad680080afdb_7b157a99-dd24-4fbf-b66e-862080f225ea.html,,,,,, "Fuels, diesel",68334-30-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9d12b08-0733-472e-be2d-7e26bfa332e9/documents/246ae508-16eb-446c-afd1-ad680080afdb_7b157a99-dd24-4fbf-b66e-862080f225ea.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,30 mg/kg bw/day,,rat "Fuels, diesel",68334-30-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9d12b08-0733-472e-be2d-7e26bfa332e9/documents/246ae508-16eb-446c-afd1-ad680080afdb_7b157a99-dd24-4fbf-b66e-862080f225ea.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Fuels, diesel",68334-30-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9d12b08-0733-472e-be2d-7e26bfa332e9/documents/246ae508-16eb-446c-afd1-ad680080afdb_7b157a99-dd24-4fbf-b66e-862080f225ea.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Fuels, diesel",68334-30-5," Acute Oral Toxicity: Acute oral toxicity of #2 home heating oil, was evaluated in male and female rats following a single oral gavage administration of the test material at different concentrations (similar to OECD 401).  The  LD50 for #2 home heating oil is 21.1 mL/kg body weight (approx 17,900 mg/kg). Based on all acute oral toxicity studies, the LD50 for VGOs/HGOs/Distillate fuels is > 5000 mg/kg bw. Acute Inhalation Toxicity: Acute inhalation toxicity of naval distillate in male and female rats was evaluated in a study involving whole-body exposure  for 4 hours (similar to OECD 403).  The acute inhalation LC50 was 4.1 mg/L . Acute Dermal Toxicity: In an acute dermal toxicity study, male and female New Zealand White rabbits were exposed to #2 home heating oil for 24 hours at a dose level of 5 mL/kg (approx 4300 mg/kg). The animals were then observed for 14 days (similar to OECD 402).  Based on this study, the acute dermal LD50 is > 4300 mg/kg.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9d12b08-0733-472e-be2d-7e26bfa332e9/documents/50ca8717-e805-460b-bb99-b647882e2c88_7b157a99-dd24-4fbf-b66e-862080f225ea.html,,,,,, "Fuels, diesel",68334-30-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9d12b08-0733-472e-be2d-7e26bfa332e9/documents/50ca8717-e805-460b-bb99-b647882e2c88_7b157a99-dd24-4fbf-b66e-862080f225ea.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Fuels, diesel",68334-30-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9d12b08-0733-472e-be2d-7e26bfa332e9/documents/50ca8717-e805-460b-bb99-b647882e2c88_7b157a99-dd24-4fbf-b66e-862080f225ea.html,,dermal,LD50,"4,300 mg/kg bw",no adverse effect observed, "Fuels, diesel",68334-30-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9d12b08-0733-472e-be2d-7e26bfa332e9/documents/50ca8717-e805-460b-bb99-b647882e2c88_7b157a99-dd24-4fbf-b66e-862080f225ea.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "(2RS,3SR)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[( 1H-1,2,4-triazol-1-yl)methyl]oxirane",133855-98-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The quality of the database is of good quality (reliability 1). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The quality of the database is of good quality (reliability 1). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The quality of the database is of good quality (reliability 1). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/802967e6-ee3f-43d6-8d49-397e356d07c1/documents/f1823714-29cd-4bc4-875f-b009f36dea27_5b636b5b-f163-4e7d-9f3f-1712884325c2.html,,,,,, "(2RS,3SR)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[( 1H-1,2,4-triazol-1-yl)methyl]oxirane",133855-98-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/802967e6-ee3f-43d6-8d49-397e356d07c1/documents/f1823714-29cd-4bc4-875f-b009f36dea27_5b636b5b-f163-4e7d-9f3f-1712884325c2.html,,oral,LD50,"5,000 mg/kg bw",adverse effect observed, "(2RS,3SR)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[( 1H-1,2,4-triazol-1-yl)methyl]oxirane",133855-98-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/802967e6-ee3f-43d6-8d49-397e356d07c1/documents/f1823714-29cd-4bc4-875f-b009f36dea27_5b636b5b-f163-4e7d-9f3f-1712884325c2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "(2RS,3SR)-3-(2-chlorophenyl)-2-(4-fluorophenyl)-[( 1H-1,2,4-triazol-1-yl)methyl]oxirane",133855-98-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/802967e6-ee3f-43d6-8d49-397e356d07c1/documents/f1823714-29cd-4bc4-875f-b009f36dea27_5b636b5b-f163-4e7d-9f3f-1712884325c2.html,,inhalation,LC50,"5,300 mg/m3",adverse effect observed, Formamide,75-12-7,"Formamide was of mild toxicity in repeated dose studies using rats and mice. The oral NOAEL was 40 mg/kg bw/day for female rats (males: 80 mg/kg/day) and male and female mice in 90-day studies, based on hematological changes. In a dermal 90-day rat study, the NOAEL was 100 mg/kg bw, based on hematological changes in both sexes. The inhalation NOAEL was 0.19 mg/L, based on mild hematological changes in both sexes of the rat. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Reliable without restrictions. The study was conducted according to OECD guidelines and under GLP conditions. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Reliable without restrictions. The study was conducted similar to OECD guidelines and under GLP conditions. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Reliable without restrictions. The study was conducted similar to OECD guidelines and under GLP conditions. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c0b1057-b665-4d65-b64e-69e5d2967755/documents/32b237ac-4741-4b7c-a154-463c9a938e8d_0de81289-6380-42dd-94c7-ed006716b975.html,,,,,, Formamide,75-12-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c0b1057-b665-4d65-b64e-69e5d2967755/documents/32b237ac-4741-4b7c-a154-463c9a938e8d_0de81289-6380-42dd-94c7-ed006716b975.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,190 mg/m3,,rat Formamide,75-12-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c0b1057-b665-4d65-b64e-69e5d2967755/documents/32b237ac-4741-4b7c-a154-463c9a938e8d_0de81289-6380-42dd-94c7-ed006716b975.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat Formamide,75-12-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c0b1057-b665-4d65-b64e-69e5d2967755/documents/32b237ac-4741-4b7c-a154-463c9a938e8d_0de81289-6380-42dd-94c7-ed006716b975.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,,rat Formamide,75-12-7,"The oral rat LD50 was approx. 5325 mg/kg bw in a pre-guideline study that was conducted similar to the method described in OECD TG 401.The inhalation LC50 is > 21 mg/L (4 hr, in the atmosphere generated using an evaporator heated to 100-210°C). The acute dermal LD50 in rats is estimated to be > 3000 mg/kg bw, based on two independent OECD TG 411 90-day repeated dose rat studies. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c0b1057-b665-4d65-b64e-69e5d2967755/documents/8329c379-2b3c-43eb-b42c-8502be573cef_0de81289-6380-42dd-94c7-ed006716b975.html,,,,,, Formamide,75-12-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c0b1057-b665-4d65-b64e-69e5d2967755/documents/8329c379-2b3c-43eb-b42c-8502be573cef_0de81289-6380-42dd-94c7-ed006716b975.html,,oral,LD50,"5,325 mg/kg bw",no adverse effect observed, Formamide,75-12-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c0b1057-b665-4d65-b64e-69e5d2967755/documents/8329c379-2b3c-43eb-b42c-8502be573cef_0de81289-6380-42dd-94c7-ed006716b975.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, Formamide,75-12-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c0b1057-b665-4d65-b64e-69e5d2967755/documents/8329c379-2b3c-43eb-b42c-8502be573cef_0de81289-6380-42dd-94c7-ed006716b975.html,,inhalation,LC50,"21,000 mg/m3",no adverse effect observed, "Distillates (petroleum), hydrodesulfurized middle",64742-80-9," There are three sub-acute repeated dose oral studies conducted according to OECD TG 422 and one 90 -day oral toxicity study according to OECD TG 408. In a 90-day oral study on CAS 64742-79-6, there were no treatment related adverse effects on systemic toxicity up to and including the highest dose of 1000 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 1000 mg/kg/day corresponding achieved dose level of 970 mg/kg/day for males and 971 mg/kg/day for females (under the test conditions and doses employed). In sub-acute oral studies on CAS 64742-79-6 and CAS 64742-46-7, there were no treatment-related adverse effects on systemic toxicity parameters up to and including the highest doses tested (1000 and 750 mg/kg/day respectively) and accordingly the NOAELs were set at these levels. In a sub-acute oral study on CAS 64742-80-9 (conducted according to OECD TG 422) at doses of 100, 300 and 1000 mg/kg/day. At 300 mg/kg/day, there were minimal gross pathological, histopathological, or biochemical treatment-related effects such as higher liver weights, spleen weights, hypertrophy in liver, follicular epithelial hypertrophy in thyroid and hyaline droplets in kidneys. This dose was determined to be the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats. A second OECD 422 study on CAS 64742-80-9 has recently reported and is included as an endpoint study record; results and potential follow-up actions (further testing proposals and/or classification) are currently under discussion and are not yet included in this summary section. In two 28-day inhalation studies with hydrodesulphurised middle distillates(CAS 64742-80-9), the Lowest Observed Adverse Effect Level (LOAEL) values were 23 and 24 mg/m3(equivalent to OECD TG 412).  These studies and values were considered unreliable.     A 90-day inhalation study of diesel fuel (aerosol) (a read-across study from VHGO category; substance CAS 68334-30-5) resulted in a conservative sub-chronic No Observed Adverse Effect Concentration (NOAEC) of 0.88 mg/L determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of greater than or equal to 1.71 mg/L was established for systemic effects, based on no significant findings at this level (OECD TG 413).   The systemic NOAEL for 28-day dermal exposure to other gas oils was 1000 mg/kg/day, based on moribund state and early mortality in the higher dose groups (OECD TG 410).   In a read-across study (from the CrackedGO category; substance CAS 64741-59-9), a systemic NOAEL of 25 mg/kg body weight/day was obtained for males, and 125 mg/kg body weight/day for females, based upon reductions in thymus weight (OECD TG 411).  In another 90-day sub-chronic study (OECD TG 411),  dermal exposure to coker light gas oil resulted in a systemic LOAEL of 30 mg/kg body weight/day for males and females, based upon clinical signs and irritation noted at all doses. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1aa74843-858b-4b3b-85ed-ad8384fda7a4/documents/4153b25a-c693-4dd2-840b-48bff6f387a4_2b9b5a71-4867-425a-b179-46033ce11a02.html,,,,,, "Distillates (petroleum), hydrodesulfurized middle",64742-80-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1aa74843-858b-4b3b-85ed-ad8384fda7a4/documents/4153b25a-c693-4dd2-840b-48bff6f387a4_2b9b5a71-4867-425a-b179-46033ce11a02.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Distillates (petroleum), hydrodesulfurized middle",64742-80-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1aa74843-858b-4b3b-85ed-ad8384fda7a4/documents/4153b25a-c693-4dd2-840b-48bff6f387a4_2b9b5a71-4867-425a-b179-46033ce11a02.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), hydrodesulfurized middle",64742-80-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1aa74843-858b-4b3b-85ed-ad8384fda7a4/documents/4153b25a-c693-4dd2-840b-48bff6f387a4_2b9b5a71-4867-425a-b179-46033ce11a02.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Distillates (petroleum), hydrodesulfurized middle",64742-80-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1aa74843-858b-4b3b-85ed-ad8384fda7a4/documents/4153b25a-c693-4dd2-840b-48bff6f387a4_2b9b5a71-4867-425a-b179-46033ce11a02.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Distillates (petroleum), hydrodesulfurized middle",64742-80-9,"Acute Oral Toxicity:The acute oral LD50 for other gas oils is > 5000 mg/kg of bodyweight in male and female rats, based on no mortality and minimal signs of toxicity (OECD 401).Acute Inhalation Toxicity:The acute inhalation LC50 for other gas oils for both male and female rats is 4.6 mg/L (aerosol) (OECD 403). This is supported by a further study  in which a hydrodesulphurised middle distillate gave an LC50 of 7.64 mg/L (aerosol). In addition a read-across study with a straight run gas oil gave an LC50 of >2.53 mg/lAcute Dermal Toxicity:The acute dermal LD50 for other gas oils is > 2000mg/kg body weight for male and female rabbits, based on no mortality or evidence of adverse effects (OECD 402). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aa74843-858b-4b3b-85ed-ad8384fda7a4/documents/c88d6084-86a3-40df-b097-077ae945a66f_2b9b5a71-4867-425a-b179-46033ce11a02.html,,,,,, "Distillates (petroleum), hydrodesulfurized middle",64742-80-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aa74843-858b-4b3b-85ed-ad8384fda7a4/documents/c88d6084-86a3-40df-b097-077ae945a66f_2b9b5a71-4867-425a-b179-46033ce11a02.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrodesulfurized middle",64742-80-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aa74843-858b-4b3b-85ed-ad8384fda7a4/documents/c88d6084-86a3-40df-b097-077ae945a66f_2b9b5a71-4867-425a-b179-46033ce11a02.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrodesulfurized middle",64742-80-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aa74843-858b-4b3b-85ed-ad8384fda7a4/documents/c88d6084-86a3-40df-b097-077ae945a66f_2b9b5a71-4867-425a-b179-46033ce11a02.html,,inhalation,LC50,"4,600 mg/m3",no adverse effect observed, "4,4'-oxydianiline",101-80-4," Reliable chronic toxicity studies are available, with appropriate species, dosage, solvent and route of administration: a 90-day feeding study in both the rats and mice and a 2 -year feeding carcinogenicity study in both the rat and mouse. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef1fdfbb-2b77-481b-bdda-7c82680e6772/documents/IUC5-13f4f78f-5329-4c0b-81d2-dedffbc707ca_3da345a0-26d0-452e-baaf-514d5bb19da3.html,,,,,, "4,4'-oxydianiline",101-80-4,"The substance was administered orally insingle doses to rats. The Approximate Lethal Dose (ALD) by this route was estimated between 1500 and 1000 mg/kg of body weight.    The substance was applied to the skin of male rabbits as a 10% solution in DMAC. The Approximate Lethal Dose (ALD) by this route was estimated between 1000 and 670 mg/kg of body weight.    No data are available for the assessment of the toxicity after an acute exposure by inhalation. It should be noted that the substance has an harmonized european classification in the Annex VI of the CLP regulation. According to this regulation, the substance must be considered as ""Toxic"" by oral route and classified H301 category 3.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef1fdfbb-2b77-481b-bdda-7c82680e6772/documents/IUC5-67a58b92-f406-484c-861a-567fba911ad9_3da345a0-26d0-452e-baaf-514d5bb19da3.html,,,,,, "4,4'-oxydianiline",101-80-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef1fdfbb-2b77-481b-bdda-7c82680e6772/documents/IUC5-67a58b92-f406-484c-861a-567fba911ad9_3da345a0-26d0-452e-baaf-514d5bb19da3.html,,oral,discriminating dose,"1,500 mg/kg bw",adverse effect observed, "4,4'-oxydianiline",101-80-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef1fdfbb-2b77-481b-bdda-7c82680e6772/documents/IUC5-67a58b92-f406-484c-861a-567fba911ad9_3da345a0-26d0-452e-baaf-514d5bb19da3.html,,dermal,discriminating dose,"1,000 mg/kg bw",adverse effect observed, "Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based",72623-87-1,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98a55a3d-8445-4fec-adad-834b9b9205d8/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_167812f9-55ff-4ae9-b268-c05e4c9c82d9.html,,,,,, "Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based",72623-87-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98a55a3d-8445-4fec-adad-834b9b9205d8/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_167812f9-55ff-4ae9-b268-c05e4c9c82d9.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based",72623-87-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98a55a3d-8445-4fec-adad-834b9b9205d8/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_167812f9-55ff-4ae9-b268-c05e4c9c82d9.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based",72623-87-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98a55a3d-8445-4fec-adad-834b9b9205d8/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_167812f9-55ff-4ae9-b268-c05e4c9c82d9.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based",72623-87-1,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98a55a3d-8445-4fec-adad-834b9b9205d8/documents/73761dae-46d6-428e-8e40-e5cc70088d96_167812f9-55ff-4ae9-b268-c05e4c9c82d9.html,,,,,, "Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based",72623-87-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98a55a3d-8445-4fec-adad-834b9b9205d8/documents/73761dae-46d6-428e-8e40-e5cc70088d96_167812f9-55ff-4ae9-b268-c05e4c9c82d9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based",72623-87-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98a55a3d-8445-4fec-adad-834b9b9205d8/documents/73761dae-46d6-428e-8e40-e5cc70088d96_167812f9-55ff-4ae9-b268-c05e4c9c82d9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Lubricating oils (petroleum), C20-50, hydrotreated neutral oil-based",72623-87-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98a55a3d-8445-4fec-adad-834b9b9205d8/documents/73761dae-46d6-428e-8e40-e5cc70088d96_167812f9-55ff-4ae9-b268-c05e4c9c82d9.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Chlorothalonil,1897-45-6," - Oral: NOAEL = 10.3 and 10.2 mg/kg bw/day for males and females, respectively, rat, sub-chronic, 90 days, feed, no guideline, Colley 1983 - Oral: LOAEL = 15 mg/kg bw/day, dogs, sub-chronic, 90 days, capsule, EPA OPP 82 -1, Fillmore 1993 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7f4d811-4ec3-4426-b306-6ba832bd45d2/documents/1ddde40d-1753-4d82-81d5-2673674c5c98_1f8e2a27-bb13-43cc-aadc-2384aada945b.html,,,,,, Chlorothalonil,1897-45-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7f4d811-4ec3-4426-b306-6ba832bd45d2/documents/1ddde40d-1753-4d82-81d5-2673674c5c98_1f8e2a27-bb13-43cc-aadc-2384aada945b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10.2 mg/kg bw/day,,rat Chlorothalonil,1897-45-6," - Oral: LD50 > 5000 mg/kg bw, male/female, rat, according to EPA OPPTS 870.1100, Moore 2000 - Inhalation: LC50 = 0.10 mg/L, males/female, rat, according to EPA OPP 81-3, Shults 1993 - Dermal: LD50 > 5000 mg/kg bw, male/female, rat, according to OECD 402, Johnson 2000 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7f4d811-4ec3-4426-b306-6ba832bd45d2/documents/1aa5b677-744e-4785-9cd5-45e6f7d4ee71_1f8e2a27-bb13-43cc-aadc-2384aada945b.html,,,,,, Chlorothalonil,1897-45-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7f4d811-4ec3-4426-b306-6ba832bd45d2/documents/1aa5b677-744e-4785-9cd5-45e6f7d4ee71_1f8e2a27-bb13-43cc-aadc-2384aada945b.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Chlorothalonil,1897-45-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7f4d811-4ec3-4426-b306-6ba832bd45d2/documents/1aa5b677-744e-4785-9cd5-45e6f7d4ee71_1f8e2a27-bb13-43cc-aadc-2384aada945b.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Chlorothalonil,1897-45-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7f4d811-4ec3-4426-b306-6ba832bd45d2/documents/1aa5b677-744e-4785-9cd5-45e6f7d4ee71_1f8e2a27-bb13-43cc-aadc-2384aada945b.html,,inhalation,LC50,100 mg/m3,adverse effect observed, "Distillates (petroleum), hydrotreated light naphthenic",64742-53-6,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/172930de-31c2-43d8-9f29-c3185907601a/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_61e8ca6f-edfa-4a91-8c32-5451c4cd09c1.html,,,,,, "Distillates (petroleum), hydrotreated light naphthenic",64742-53-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/172930de-31c2-43d8-9f29-c3185907601a/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_61e8ca6f-edfa-4a91-8c32-5451c4cd09c1.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Distillates (petroleum), hydrotreated light naphthenic",64742-53-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/172930de-31c2-43d8-9f29-c3185907601a/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_61e8ca6f-edfa-4a91-8c32-5451c4cd09c1.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Distillates (petroleum), hydrotreated light naphthenic",64742-53-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/172930de-31c2-43d8-9f29-c3185907601a/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_61e8ca6f-edfa-4a91-8c32-5451c4cd09c1.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Distillates (petroleum), hydrotreated light naphthenic",64742-53-6,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/172930de-31c2-43d8-9f29-c3185907601a/documents/73761dae-46d6-428e-8e40-e5cc70088d96_61e8ca6f-edfa-4a91-8c32-5451c4cd09c1.html,,,,,, "Distillates (petroleum), hydrotreated light naphthenic",64742-53-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/172930de-31c2-43d8-9f29-c3185907601a/documents/73761dae-46d6-428e-8e40-e5cc70088d96_61e8ca6f-edfa-4a91-8c32-5451c4cd09c1.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated light naphthenic",64742-53-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/172930de-31c2-43d8-9f29-c3185907601a/documents/73761dae-46d6-428e-8e40-e5cc70088d96_61e8ca6f-edfa-4a91-8c32-5451c4cd09c1.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated light naphthenic",64742-53-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/172930de-31c2-43d8-9f29-c3185907601a/documents/73761dae-46d6-428e-8e40-e5cc70088d96_61e8ca6f-edfa-4a91-8c32-5451c4cd09c1.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "2,6-dibromo-4-cyanophenyl octanoate",1689-99-2," Oral subchronic toxicity Key, M-166147-01-1; subchronic (90 d, rat, similar to OECD 408, GLP): NOAEL (systemic): 150 ppm (corresponding to 1.6 mg/kg bw/day in males and 1.8 in mg/kg bw/day females, respectively) LOAEL (systemic): 600 ppm (corresponding to 6.5 mg/kg bw/day in males and 7.8 in mg/kg bw/day females, respectively)   Key, M-227060-01-1; subchronic (90 d, dog, similar to OECD 409, GLP): NOAEL (systemic): 1.43 mg/kg bw/day (males and females) LOAEL (systemic): 7.14 mg/kg bw/day (males and females)   Oral chronic toxicity Key, source, RA-A, CAS 1689-84-5, M-240-237-03-1; chronic (52 wks, dog, similar to OECD 452, GLP): NOAEL (systemic): 0.3 mg/kg bw/day (males and females) LOAEL (systemic): 1.5 mg/kg bw/day (males and females)   Dermal subacute toxicity Key, M-227015-01-2; subacute (21 d, rabbit, OECD 410, GLP): NOAEL (systemic): 1000 mg/kg bw/day (males and females) NOAEL (local): 30 mg/kg bw/day (males and females) LOAEL (local): 300 mg/kg bw/day (males and females) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/704f991a-a01e-4bb5-8d40-649f7be35396/documents/5b50fdc1-b726-42a3-bf15-44fc0d22cd7b_24134e66-1bd1-4131-bd99-ea75340ddc8d.html,,,,,, "2,6-dibromo-4-cyanophenyl octanoate",1689-99-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/704f991a-a01e-4bb5-8d40-649f7be35396/documents/5b50fdc1-b726-42a3-bf15-44fc0d22cd7b_24134e66-1bd1-4131-bd99-ea75340ddc8d.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rabbit "2,6-dibromo-4-cyanophenyl octanoate",1689-99-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/704f991a-a01e-4bb5-8d40-649f7be35396/documents/5b50fdc1-b726-42a3-bf15-44fc0d22cd7b_24134e66-1bd1-4131-bd99-ea75340ddc8d.html,Chronic toxicity – systemic effects,oral,NOAEL,0.3 mg/kg bw/day,,dog "2,6-dibromo-4-cyanophenyl octanoate",1689-99-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/704f991a-a01e-4bb5-8d40-649f7be35396/documents/5b50fdc1-b726-42a3-bf15-44fc0d22cd7b_24134e66-1bd1-4131-bd99-ea75340ddc8d.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.39 mg/cm2,adverse effect observed,rabbit "2,6-dibromo-4-cyanophenyl octanoate",1689-99-2," WoE, M-185067-01-2; oral (rat, OECD 401, GLP): LD50 = 141 mg/kg bw (females) WoE, M-253375-01-1; oral (rat, FIFRA: Federal Register, Vol. 43, No. 163, pre-GLP): LD50 = 400 mg/kg bw (males) and 238 mg/kg bw (females) Key, M-226980-01-1; inhalation (rat, EPA OPP 81-3, GLP): LC50 = 0.81 mg/L (males) and 0.72 mg/L (females) Key, M-185070-01-2; dermal (rat, OECD 402, GLP): LD50 > 2000 mg/kg bw (males and females) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/704f991a-a01e-4bb5-8d40-649f7be35396/documents/45efa71d-0683-4258-97a8-9c92803f399a_24134e66-1bd1-4131-bd99-ea75340ddc8d.html,,,,,, "2,6-dibromo-4-cyanophenyl octanoate",1689-99-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/704f991a-a01e-4bb5-8d40-649f7be35396/documents/45efa71d-0683-4258-97a8-9c92803f399a_24134e66-1bd1-4131-bd99-ea75340ddc8d.html,,oral,LD50,141 mg/kg bw,adverse effect observed, "2,6-dibromo-4-cyanophenyl octanoate",1689-99-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/704f991a-a01e-4bb5-8d40-649f7be35396/documents/45efa71d-0683-4258-97a8-9c92803f399a_24134e66-1bd1-4131-bd99-ea75340ddc8d.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,6-dibromo-4-cyanophenyl octanoate",1689-99-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/704f991a-a01e-4bb5-8d40-649f7be35396/documents/45efa71d-0683-4258-97a8-9c92803f399a_24134e66-1bd1-4131-bd99-ea75340ddc8d.html,,inhalation,LC50,0.72 mg/L,adverse effect observed, Bromomethane,74-83-9,"Methyl Bromide is toxic by the oral and inhalation routes described in this set of experiments. Evidence of this toxicity was seen in a reduction of body weights throughout a number of studies. Mortality findings, alterations of the forestomach mucosa of rats and a reduction in absolute liver weights were also taken as signs of the toxic effect of Methyl Bromide. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ced3ec23-9b83-4504-b002-9e6f861359e1/documents/IUC5-620b6a77-75f9-470a-b15a-8e7d0b876c03_dbab2519-7378-430e-a1f8-a9e427f62783.html,,,,,, Bromomethane,74-83-9,"An overview of the studies described in 7.2.1 to 7.2.3 is given in table.Parameter Test material Species Result ReferenceAcute oral LD50 Methyl Bromide Rat 104 mg/kg bw Kiplinger, 1994Acute percutaneous LD50 Methyl Bromide Rat 135mg/kg bw Tanaka et al, 1998Acute inhalation LC50 (8h) Methyl Bromide Rat 1167 mg/L (8 h) Honma et al, 1985 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ced3ec23-9b83-4504-b002-9e6f861359e1/documents/IUC5-c3f24405-7a85-4f0d-b1e8-34faeca481d3_dbab2519-7378-430e-a1f8-a9e427f62783.html,,,,,, Bromomethane,74-83-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ced3ec23-9b83-4504-b002-9e6f861359e1/documents/IUC5-c3f24405-7a85-4f0d-b1e8-34faeca481d3_dbab2519-7378-430e-a1f8-a9e427f62783.html,,oral,LD50,133 mg/kg bw,, Bromomethane,74-83-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ced3ec23-9b83-4504-b002-9e6f861359e1/documents/IUC5-c3f24405-7a85-4f0d-b1e8-34faeca481d3_dbab2519-7378-430e-a1f8-a9e427f62783.html,,dermal,LD50,135 mg/kg bw,, Bromomethane,74-83-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ced3ec23-9b83-4504-b002-9e6f861359e1/documents/IUC5-c3f24405-7a85-4f0d-b1e8-34faeca481d3_dbab2519-7378-430e-a1f8-a9e427f62783.html,,inhalation,LC50,"1,167 mg/m3",, Nicotine,54-11-5," Studies of repeated dermal and oral toxicity of nicotine are not available. According to the REACH regulation, Annex VIII, 8.6.1 the most appropriate route of administration, having regard to the likely route of human exposure should be used. Based on the consumer end-use of nicotine within nicotine containing products the inhalation route of exposure was chosen for the repeated dose toxicity key study (OECD 422). The systemic effects observed after repeated inhalation administration were clearly adverse and therefore are taken into account in risk assessment. There are no data gaps in repeated dose toxicity. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/230cf09e-feee-4dde-a424-6a7e94140612/documents/9cf1f0c2-bf07-41d4-90f6-8a4c0d48f911_b9d7d042-b257-4cb0-97c4-c3eb1039e7f5.html,,,,,, Nicotine,54-11-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/230cf09e-feee-4dde-a424-6a7e94140612/documents/9cf1f0c2-bf07-41d4-90f6-8a4c0d48f911_b9d7d042-b257-4cb0-97c4-c3eb1039e7f5.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,"10,000 ",, Nicotine,54-11-5," Classification for acute oral toxicity was performed based on a weight of evidence analysis, since no key study of high quality (Klimisch 1) is available. The results of these studies should be used cautiously. However, the overall quality of the data base is appropriate for risk assessment, which was confirmed by RAC in its decision process on current harmonised classification. The studies for acute inhalation and acute dermal toxicity are both of good quality (Klimisch 1(dermal) and Klimisch 2 (inhalation)) and GLP compliant, therefore no further testing is needed. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/230cf09e-feee-4dde-a424-6a7e94140612/documents/11a6e9d1-becd-435c-8c0a-e414759cb24a_b9d7d042-b257-4cb0-97c4-c3eb1039e7f5.html,,,,,, Nicotine,54-11-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/230cf09e-feee-4dde-a424-6a7e94140612/documents/11a6e9d1-becd-435c-8c0a-e414759cb24a_b9d7d042-b257-4cb0-97c4-c3eb1039e7f5.html,,oral,LD50,9 mg/kg bw,adverse effect observed, Nicotine,54-11-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/230cf09e-feee-4dde-a424-6a7e94140612/documents/11a6e9d1-becd-435c-8c0a-e414759cb24a_b9d7d042-b257-4cb0-97c4-c3eb1039e7f5.html,,dermal,LD50,70.4 mg/kg bw,adverse effect observed, Nicotine,54-11-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/230cf09e-feee-4dde-a424-6a7e94140612/documents/11a6e9d1-becd-435c-8c0a-e414759cb24a_b9d7d042-b257-4cb0-97c4-c3eb1039e7f5.html,,inhalation,LC50,190 mg/m3,adverse effect observed, Glycerol trinitrate,55-63-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0145616-fd09-4ce4-8f7f-164f3e404cd0/documents/IUC5-a0d5d4a6-d27f-4f67-b5b9-255e7395f5d9_0d319cc6-9a83-4f9f-9251-b21349d7d33f.html,Chronic toxicity – systemic effects,oral,LOAEL,1 mg/kg bw/day,,dog Glycerol trinitrate,55-63-0,GTN is harmful.Acute toxicity by oral was done on ratsAcute toxicity by dermal was done on ratsAcute toxicity by inhalation - study technically not feasible ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0145616-fd09-4ce4-8f7f-164f3e404cd0/documents/IUC5-e805e3f5-7be8-43dd-a859-f590f6697cb7_0d319cc6-9a83-4f9f-9251-b21349d7d33f.html,,,,,, Glycerol trinitrate,55-63-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0145616-fd09-4ce4-8f7f-164f3e404cd0/documents/IUC5-e805e3f5-7be8-43dd-a859-f590f6697cb7_0d319cc6-9a83-4f9f-9251-b21349d7d33f.html,,oral,LD50,853 mg/kg bw,, Glycerol trinitrate,55-63-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0145616-fd09-4ce4-8f7f-164f3e404cd0/documents/IUC5-e805e3f5-7be8-43dd-a859-f590f6697cb7_0d319cc6-9a83-4f9f-9251-b21349d7d33f.html,,dermal,LD50,"9,560 mg/kg bw",, "N,N-dimethylacetamide",127-19-5," The most relevant studies revealed following results.   Oral: 24-months rat drinking water study: NOAEL = 100 mg/kg bw/day (males) based on reduced body weight. Histopathological effects on testes and liver observed at the high dose, exceeding the MTD (1000 mg/kg bw/day). Reliability of NOAEL limited due to limitation of the histopathological assessment to control and high dose. [Monsanto, 1979; RL2 (reliability)] 90-days rat feeding study: NOAEL ≥ 60 mg/kg bw/day. No adverse effects observed at the only dose tested. [Kennedy & Sherman, 1986; RL2] 28-days rat gavage study: LOAEL = 290 mg/kg bw/day. A NOEAL was not determinable due to adverse toxic effects at the lowest tested dose (decreased organ weights, uterus atrophy). [BASF, 1975; RL2] Pilot study, 31 -days rat, drinking water: NOAEL = 1000 mg/kg bw/d. [Monsanto, 1976; RL2]   Inhalation: 24-months rat whole body inhalation (vapor): NOAEC = 25 ppm (90 mg/m³) based on body weight, clinical chemistry parameters, histopathological changes in the liver [Malley et al., 1995; RL2] 18-months mouse whole body inhalation (vapor): NOAEC = 25 ppm (90 mg/m³) based on histopathological changes in the liver. [Malley et al., 1995; RL1] 2-weeks mouse whole body inhalation (vapor): NOAEC = 100 ppm (360 mg/m³, males) based on effects on testes. [Valentine et al., 1997; RL2] 12 d (3, 6, 12 h), rat, inhalation: NOAEC (12 h) = 100 ppm, based on histopathological effects in the liver at 300 ppm. [Kinney et al., 1993; RL2]   Dermal: 6-months dog dermal exposure study: NOAEL = 94 mg/kg bw/day based on body weight and clinical chemistry parameters. [Horn, 1961; RL2] ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57e32a08-96bb-4462-b14c-f65d514ee2a7/documents/IUC5-42ed455c-abba-446b-a7a3-bc0e9a805143_82fd695f-ac5f-455f-b4f5-dddd89409553.html,,,,,, "N,N-dimethylacetamide",127-19-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57e32a08-96bb-4462-b14c-f65d514ee2a7/documents/IUC5-42ed455c-abba-446b-a7a3-bc0e9a805143_82fd695f-ac5f-455f-b4f5-dddd89409553.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,94 mg/kg bw/day,,dog "N,N-dimethylacetamide",127-19-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57e32a08-96bb-4462-b14c-f65d514ee2a7/documents/IUC5-42ed455c-abba-446b-a7a3-bc0e9a805143_82fd695f-ac5f-455f-b4f5-dddd89409553.html,Chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "N,N-dimethylacetamide",127-19-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57e32a08-96bb-4462-b14c-f65d514ee2a7/documents/IUC5-42ed455c-abba-446b-a7a3-bc0e9a805143_82fd695f-ac5f-455f-b4f5-dddd89409553.html,Chronic toxicity – systemic effects,inhalation,NOAEC,90 mg/m3,,rat "N,N-dimethylacetamide",127-19-5,"Oral LD50: 4800-5830 mg/kg bw (rat), 4610-6020 mg/kg bw (mouse), 2820 mg/kg bw (rabbit).Inhalation LC50 (rat, 4h) estimated to be 2.2 mg/L (for aerosol). Dermal LD50 (rabbit): 2100 mg/kg bw. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57e32a08-96bb-4462-b14c-f65d514ee2a7/documents/IUC5-d1f00bd5-0ed2-4dd6-8e44-8f4e7cc555d5_82fd695f-ac5f-455f-b4f5-dddd89409553.html,,,,,, "N,N-dimethylacetamide",127-19-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57e32a08-96bb-4462-b14c-f65d514ee2a7/documents/IUC5-d1f00bd5-0ed2-4dd6-8e44-8f4e7cc555d5_82fd695f-ac5f-455f-b4f5-dddd89409553.html,,oral,LD50,"5,830 mg/kg bw",no adverse effect observed, "N,N-dimethylacetamide",127-19-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57e32a08-96bb-4462-b14c-f65d514ee2a7/documents/IUC5-d1f00bd5-0ed2-4dd6-8e44-8f4e7cc555d5_82fd695f-ac5f-455f-b4f5-dddd89409553.html,,dermal,LD50,"2,100 mg/kg bw",adverse effect observed, "N,N-dimethylacetamide",127-19-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57e32a08-96bb-4462-b14c-f65d514ee2a7/documents/IUC5-d1f00bd5-0ed2-4dd6-8e44-8f4e7cc555d5_82fd695f-ac5f-455f-b4f5-dddd89409553.html,,inhalation,LC50,"2,200 mg/m3",adverse effect observed, Allyl isothiocyanate,57-06-7," The main effects observed in short-term toxicity studies in rats and mice, dosed by gavage, were a thickened mucosal surface of the stomach, adhesion of the stomach to the peritoneum and a thickened urinary bladder wall (the latter change being mainly observed in the males of both species). This indicates that AITC has irritant effects on these tissues. The No-Observed-Adverse-Effect-Levels (NOAELs) from short-term and subchronic toxicity studies in rats and mice which received AITC by gavage were in the range of 10 to 25 mg/kg bw/day. The NOAELs identified in subchronic toxicity studies were mainly based on the effects on kidney, stomach and urinary bladder observed at higher doses. (EFSA, 2010) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2139d165-d4ff-4c4c-94cf-042a030f577d/documents/538ae0ed-65f7-42bf-941e-45111eba2998_146e0168-176e-4d39-b541-ea84d89b97e2.html,,,,,, Allyl isothiocyanate,57-06-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2139d165-d4ff-4c4c-94cf-042a030f577d/documents/538ae0ed-65f7-42bf-941e-45111eba2998_146e0168-176e-4d39-b541-ea84d89b97e2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Allyl isothiocyanate,57-06-7," Acute toxicity studies with AITC have been performed by oral, dermal and inhalation routes of exposure. The acute LD50 of AITC by oral route is estimated to be 425.4 mg/kg bw in rats. The acute LD50 of AITC by dermal route was between 200 and 2,000 mg/kg bw in rats. The acute LC50 of AITC by inhalation route was between 0.206 and 0.508 mg/L/4h in rats. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2139d165-d4ff-4c4c-94cf-042a030f577d/documents/401e3437-1789-4c8a-a59a-48b03b96fbf1_146e0168-176e-4d39-b541-ea84d89b97e2.html,,,,,, Allyl isothiocyanate,57-06-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2139d165-d4ff-4c4c-94cf-042a030f577d/documents/401e3437-1789-4c8a-a59a-48b03b96fbf1_146e0168-176e-4d39-b541-ea84d89b97e2.html,,oral,LD50,425.4 mg/kg bw,adverse effect observed, Allyl isothiocyanate,57-06-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2139d165-d4ff-4c4c-94cf-042a030f577d/documents/401e3437-1789-4c8a-a59a-48b03b96fbf1_146e0168-176e-4d39-b541-ea84d89b97e2.html,,dermal,LD50,200 mg/kg bw,adverse effect observed, Allyl isothiocyanate,57-06-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2139d165-d4ff-4c4c-94cf-042a030f577d/documents/401e3437-1789-4c8a-a59a-48b03b96fbf1_146e0168-176e-4d39-b541-ea84d89b97e2.html,,inhalation,LC50,206 mg/m3,adverse effect observed, "Butyl 2,3-epoxypropyl ether",2426-08-6, The 10 -week NOAEC for repeated dose inhalation toxicity was determined to be 0.2 mg/L based on severe pneumonia and slight patchy atrophy of the testis. The 28 -day NOAEC for repeated dose inhalation toxicity was determined to be 0.1 mg/L based on observed degeneration of the olfactory mucosa and hyperplastic/metaplastic changes of the ciliated respiratory epithelium. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70c951bb-42ba-47ad-9a88-09d76604b05b/documents/8775b8de-0346-4868-a49e-149c67d4a1ad_eb89a59e-e933-4c86-8d13-6999f9d61cf6.html,,,,,, "Butyl 2,3-epoxypropyl ether",2426-08-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70c951bb-42ba-47ad-9a88-09d76604b05b/documents/8775b8de-0346-4868-a49e-149c67d4a1ad_eb89a59e-e933-4c86-8d13-6999f9d61cf6.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,200 mg/m3,,rat "Butyl 2,3-epoxypropyl ether",2426-08-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70c951bb-42ba-47ad-9a88-09d76604b05b/documents/8775b8de-0346-4868-a49e-149c67d4a1ad_eb89a59e-e933-4c86-8d13-6999f9d61cf6.html,Repeated dose toxicity – local effects,inhalation,NOAEC,100 mg/m3,adverse effect observed,rat "Butyl 2,3-epoxypropyl ether",2426-08-6, LD50 via oral route is 1530 mg/kg bw. LC50 (4h) via inhalation is 10970 mg/m3. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70c951bb-42ba-47ad-9a88-09d76604b05b/documents/75ec88e3-3d70-4aac-9813-ce6214f56df0_eb89a59e-e933-4c86-8d13-6999f9d61cf6.html,,,,,, "Butyl 2,3-epoxypropyl ether",2426-08-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70c951bb-42ba-47ad-9a88-09d76604b05b/documents/75ec88e3-3d70-4aac-9813-ce6214f56df0_eb89a59e-e933-4c86-8d13-6999f9d61cf6.html,,oral,LD50,"1,530 mg/kg bw",adverse effect observed, "Butyl 2,3-epoxypropyl ether",2426-08-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70c951bb-42ba-47ad-9a88-09d76604b05b/documents/75ec88e3-3d70-4aac-9813-ce6214f56df0_eb89a59e-e933-4c86-8d13-6999f9d61cf6.html,,inhalation,LC50,"10,970 mg/m3",adverse effect observed, "Slack wax (petroleum), hydrotreated",92062-09-4,"No oral repeat dose toxicity data are available for slack waxes (non-carcinogenic feed-stock). Data are available on similar materials (Paraffin waxes) to adequately characterize the repeated dose toxicity of slack waxes (Non-carcinogenic feed-stock). The data are consistent in that they demonstrate that paraffin and hydrocarbon waxes were found to be of low acute toxicity by the oral route.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for slack waxes (carcinogenic or unknown feed-stock) using read-across to a 90-day subchronic toxicity study that tested untreated distillate aromatic extracts. For dermal repeat dose toxicity, data are available on similar materials to adequately characterize the repeated dose toxicity of  slack waxes (carcinogenic or unknown feed-stock and non-carcinogenic feed-stock). The data are consistent in that they demonstrate minimal effects in rabbits with the exception of minimal to moderate skin irritation following repeated dermal exposures. For inhalation repeat dose toxicity, no data are available on slack waxes.  However, inhalation exposure to slack waxes is not expected to occur under normal conditions due to the very low vapour pressures of these substances. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31fe2d55-7dfb-4557-84e8-a2448fc930ea/documents/bfab73c8-6f6d-4fd7-9346-ff1bf3d1b7c2_0dccb97a-4b6d-426c-81d1-5c914f710577.html,,,,,, "Slack wax (petroleum), hydrotreated",92062-09-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31fe2d55-7dfb-4557-84e8-a2448fc930ea/documents/bfab73c8-6f6d-4fd7-9346-ff1bf3d1b7c2_0dccb97a-4b6d-426c-81d1-5c914f710577.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Slack wax (petroleum), hydrotreated",92062-09-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31fe2d55-7dfb-4557-84e8-a2448fc930ea/documents/bfab73c8-6f6d-4fd7-9346-ff1bf3d1b7c2_0dccb97a-4b6d-426c-81d1-5c914f710577.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Slack wax (petroleum), hydrotreated",92062-09-4,Read-across toxicity studies for acute oral (OECD 401) and dermal (OECD 402) toxicity  were identified for slack waxes (carcinogenic or unknown feed-stock and non-carcinogenic feedstock).  No acute inhalation toxicity studieshave been reported for slack waxes since inhalation exposure is not expected to occur under normal conditions due to the very low vapour pressures of these substances. LD50 values were as follows:• The oral LD50 was > 5000 mg/kg bw in male and female rats.• The dermal LD50 was > 2000 or 5000 mg/kg bw in male and female rabbits. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31fe2d55-7dfb-4557-84e8-a2448fc930ea/documents/d768da8b-e789-4187-9286-e7a5f3f89a50_0dccb97a-4b6d-426c-81d1-5c914f710577.html,,,,,, "Slack wax (petroleum), hydrotreated",92062-09-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31fe2d55-7dfb-4557-84e8-a2448fc930ea/documents/d768da8b-e789-4187-9286-e7a5f3f89a50_0dccb97a-4b6d-426c-81d1-5c914f710577.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Slack wax (petroleum), hydrotreated",92062-09-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31fe2d55-7dfb-4557-84e8-a2448fc930ea/documents/d768da8b-e789-4187-9286-e7a5f3f89a50_0dccb97a-4b6d-426c-81d1-5c914f710577.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-amino-3-fluorophenol,399-95-1,No internal study data on acute toxicity available for the test item. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4895576-17d9-4f27-9c37-375f3e258699/documents/IUC5-a324f2b2-f438-485b-a53a-c9ea53afbbc6_6c38f7f2-2f62-4f4c-bfb6-a34a368b3483.html,,,,,, "Distillates (petroleum), heavy steam-cracked",101631-14-5,"There are limited repeat dose toxicity data on any of the specific streams identified for this category. However, there are substantial data on the repeated dose toxicity of a number of specific components present in some streams i.e. benzene, toluene, ethylbenzene and styrene which demonstrate significant target organ toxicity. Classification will be required for streams that contain benzene or toluene at concentrations greater than or equal to 1%or 10% respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8402a8d5-94b5-4c80-bbcc-a64b418f9639/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_aaf7e269-8b49-4984-86c7-37d6259de0b8.html,,,,,, "Distillates (petroleum), heavy steam-cracked",101631-14-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8402a8d5-94b5-4c80-bbcc-a64b418f9639/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_aaf7e269-8b49-4984-86c7-37d6259de0b8.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), heavy steam-cracked",101631-14-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8402a8d5-94b5-4c80-bbcc-a64b418f9639/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_aaf7e269-8b49-4984-86c7-37d6259de0b8.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Distillates (petroleum), heavy steam-cracked",101631-14-5,"Available data for 4 specific streams within this category [Carbon Black Oil (CAS 64742-90-1), E000014200 (CAS 68475-80-9), Rohnaphthalin-Gemisch (CAS 85117-10-8), Quenchoel (CAS 98072-36-7)], further information included in the Category Summary for Fuel Oils Category (ACC, 2005), and on specific components (benzene, toluene, ethylbenzene, styrene, naphthalene and anthracene) that are present in some streams indicate that acute toxicity is expected to be low. Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Therefore, classification will be required for streams containing a high proportion of naphthalene (≥25%) and styrene (>12.5%) but the highest concentration of ethylbenzene (10%) is too low to trigger classification. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8402a8d5-94b5-4c80-bbcc-a64b418f9639/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_aaf7e269-8b49-4984-86c7-37d6259de0b8.html,,,,,, "Distillates (petroleum), heavy steam-cracked",101631-14-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8402a8d5-94b5-4c80-bbcc-a64b418f9639/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_aaf7e269-8b49-4984-86c7-37d6259de0b8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), heavy steam-cracked",101631-14-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8402a8d5-94b5-4c80-bbcc-a64b418f9639/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_aaf7e269-8b49-4984-86c7-37d6259de0b8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), heavy steam-cracked",101631-14-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8402a8d5-94b5-4c80-bbcc-a64b418f9639/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_aaf7e269-8b49-4984-86c7-37d6259de0b8.html,,inhalation,LC50,"1,860 mg/m3",no adverse effect observed, Mercury,7439-97-6,"Oral:- key study: NTP (1993)- supportive data: Jonker (1993)Dermal:- Review EuroChlor 2009 (see discussion)- weight of evidence of two human reports (Barr_1972 and Dyall-Smith_1990), see section 7.10.3Inhalation:- Review EuroChlor 2009 (see discussion)- weight of evidence of three human reports (Ellingsen_2000a,b and Ellingsen 2001), see section 7.10.3 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/562fb90c-bc2f-4fcd-8147-3eff1a56f7b2/documents/IUC5-5c728611-a29f-4370-b7f5-065f52f70d0b_457c50b4-f196-4980-ba1f-2500aef520ef.html,,,,,, Mercury,7439-97-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/562fb90c-bc2f-4fcd-8147-3eff1a56f7b2/documents/IUC5-5c728611-a29f-4370-b7f5-065f52f70d0b_457c50b4-f196-4980-ba1f-2500aef520ef.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,0.312 mg/kg bw/day,,rat Mercury,7439-97-6,"Two acute oral toxicity studies in rats with mercury chloride were considered, and one study with inhalation exposure of rats to elmental mercury. In addition, one oral study with an alloy containing about 24.8% mercury was considered as well. There is only very little information available on dermal toxicity. One study with treatment of rabbits with mercury containing ointments was considered. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/562fb90c-bc2f-4fcd-8147-3eff1a56f7b2/documents/IUC5-27e76a65-37fb-4049-bb3d-3f719300ad08_457c50b4-f196-4980-ba1f-2500aef520ef.html,,,,,, Mercury,7439-97-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/562fb90c-bc2f-4fcd-8147-3eff1a56f7b2/documents/IUC5-27e76a65-37fb-4049-bb3d-3f719300ad08_457c50b4-f196-4980-ba1f-2500aef520ef.html,,oral,LD50,35 mg/kg bw,, Isoprene,78-79-5,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyInformation.KeyInformation): There is a clear species difference in response to exposure to isoprene, with mice being more sensitive than rats.   In rats findings were essentially limited to splenic fibrosis, renal tubule hyperplasia, and interstitial cell hyperplasia of the testis. In contrast, in mice non-neoplastic toxicities include spinal cord degeneration, partial rear limb paralysis, testicular atrophy, olfactory epithelial degeneration, forestomach epithelial hyperplasia and macrocytic anaemia. The overall repeat dose NOAEC for rats is 220 ppm (613 mg/m3) based on splenic fibrosis in males. There was no overall NOAEC for mice, with the LOAEC being 70 ppm (195 mg/m3) based on increased incidence of spinal cord degeneration. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fabad38c-9b23-4e78-99b0-020c140a9afe/documents/IUC5-d8cae597-d09a-4a32-bfd8-50a7c7e588e6_14f270e3-5a77-4804-800d-4ed40b38fe2e.html,,,,,, Isoprene,78-79-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fabad38c-9b23-4e78-99b0-020c140a9afe/documents/IUC5-d8cae597-d09a-4a32-bfd8-50a7c7e588e6_14f270e3-5a77-4804-800d-4ed40b38fe2e.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,195 mg/m3,,mouse Isoprene,78-79-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fabad38c-9b23-4e78-99b0-020c140a9afe/documents/IUC5-d8cae597-d09a-4a32-bfd8-50a7c7e588e6_14f270e3-5a77-4804-800d-4ed40b38fe2e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"19,503 mg/m3",no adverse effect observed,rat Isoprene,78-79-5,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyInformation.KeyInformation): The acute toxicity data on isoprene are limited. Using a weight-of-evidence approach, the available data suggest that isoprene has a low order of acute toxicity in animals by the oral, dermal and inhalation routes of exposure. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fabad38c-9b23-4e78-99b0-020c140a9afe/documents/IUC5-a2d82a65-2ca2-44e0-bd8e-aa15946ec2e9_14f270e3-5a77-4804-800d-4ed40b38fe2e.html,,,,,, Isoprene,78-79-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fabad38c-9b23-4e78-99b0-020c140a9afe/documents/IUC5-a2d82a65-2ca2-44e0-bd8e-aa15946ec2e9_14f270e3-5a77-4804-800d-4ed40b38fe2e.html,,oral,LD50,"> 2,043 mg/kg bw",no adverse effect observed, Isoprene,78-79-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fabad38c-9b23-4e78-99b0-020c140a9afe/documents/IUC5-a2d82a65-2ca2-44e0-bd8e-aa15946ec2e9_14f270e3-5a77-4804-800d-4ed40b38fe2e.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Isoprene,78-79-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fabad38c-9b23-4e78-99b0-020c140a9afe/documents/IUC5-a2d82a65-2ca2-44e0-bd8e-aa15946ec2e9_14f270e3-5a77-4804-800d-4ed40b38fe2e.html,,inhalation,LC50,"> 135,000 mg/m3",no adverse effect observed, Azacyclonol,115-46-8," Acute toxicity - oral Available acute toxicity values for the Azacyclonol are:  - LD50oral 650 mg/kg (mouse)  - LD50oral 984 mg/kg (rat/male) - LD50oral >1000 mg/kg (rat/female)   During the acute oral toxicity study where doses administered were 750, 1000 and 1300 mg/kg, (i) no mortality was recorded among the females (1000 mg/kg), (ii) in males, mortality was 100%, 60% and 0% in the 1300, 1000 and 750 mg/kg dose-groups, respectively. Mortality occurred between day 2 and day 8.   According to the 1272/2008 CLP regulation, the substance is classified as Acute Tox.4; H302 (harmful if swallowed (LD50between 300 < categoria 4 ≤ 2 000)). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea938f12-320f-4a8d-b712-61a017625b6d/documents/15011607-bb48-454c-8fb4-2342cd3434c1_8671ba71-1ef0-4e24-b9da-67e5f35891d0.html,,,,,, Azacyclonol,115-46-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea938f12-320f-4a8d-b712-61a017625b6d/documents/15011607-bb48-454c-8fb4-2342cd3434c1_8671ba71-1ef0-4e24-b9da-67e5f35891d0.html,,oral,LD50,984 mg/kg bw,adverse effect observed, "Allyl 2,3-epoxypropyl ether",106-92-3,"The effects observed can be attributed to the irritating properties of allyl glycidyl ether (AGE), which were local effects on the nasal mucosa instead of systemic effects. The 14 days NOAEC (local effects) for inhalation toxicity in rat and mice was below 117 mg/m3. The 90 days NOAEC (local effects) for inhalation toxicity in rat and mice was lower than 19 and 4.7 mg/m3, respectively. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57070efc-804d-4c9a-86e9-d60e5058882b/documents/IUC5-9cf4e80e-d888-4084-a521-057d57a4f9ca_c6277dbc-b648-4aa2-a2a2-70cb03549aba.html,,,,,, "Allyl 2,3-epoxypropyl ether",106-92-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57070efc-804d-4c9a-86e9-d60e5058882b/documents/IUC5-9cf4e80e-d888-4084-a521-057d57a4f9ca_c6277dbc-b648-4aa2-a2a2-70cb03549aba.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,19 mg/m3,,rat "Allyl 2,3-epoxypropyl ether",106-92-3,Allyl Glycidyl Ether (AGE) is harmful if swallowed and toxic if inhaled. AGE may be harmful in contact with skin according to GHS-UN (Cat 5) standards.LD50 Oral (rat) = 830 mg/kg bw (male) and 1164 mg/kg bw (female)LD50 Dermal = 2550 mg/kg bw (rat) LC50 Inhalation-vapor (rat- 4h) = 2.56mg/l (male) ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57070efc-804d-4c9a-86e9-d60e5058882b/documents/IUC5-16754d36-3799-4759-b21a-422e304ed5be_c6277dbc-b648-4aa2-a2a2-70cb03549aba.html,,,,,, "Allyl 2,3-epoxypropyl ether",106-92-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57070efc-804d-4c9a-86e9-d60e5058882b/documents/IUC5-16754d36-3799-4759-b21a-422e304ed5be_c6277dbc-b648-4aa2-a2a2-70cb03549aba.html,,oral,LD50,830 mg/kg bw,, "Allyl 2,3-epoxypropyl ether",106-92-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57070efc-804d-4c9a-86e9-d60e5058882b/documents/IUC5-16754d36-3799-4759-b21a-422e304ed5be_c6277dbc-b648-4aa2-a2a2-70cb03549aba.html,,dermal,LD50,"2,550 mg/kg bw",, "Allyl 2,3-epoxypropyl ether",106-92-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57070efc-804d-4c9a-86e9-d60e5058882b/documents/IUC5-16754d36-3799-4759-b21a-422e304ed5be_c6277dbc-b648-4aa2-a2a2-70cb03549aba.html,,inhalation,LC50,"2,560 mg/m3",, "Distillates (petroleum), light hydrocracked",64741-77-1," There are seven oral sub-acute repeated dose oral studies conducted according to OECD TG 422. In sub-acute oral studies on CAS Numbers 64741-77-1, 68476-34-6, 68476-30-2 and 68334 -30 -5, there were no treatment-related adverse effects on systemic toxicity parameters up to and including the highest doses tested (1000 mg/kg/day for 68334 -30 -5 and 750 mg/kg/day for the remaining CAS numbers) and accordingly the NOAELs were set at these levels. In a sub-acute oral study on CAS 68476 -31 -3 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 750 mg/kg/day for males and 100 mg/kg/day for females.   In a sub-acute oral study on CAS 64741 -49 -7 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 750 mg/kg/day for males and 300 mg/kg/day for females. In a sub-acute oral study on CAS 68476 -31 -3 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 300 mg/kg/day for males and females. Supporting information is available, with two studies conducted on petroleum substances in other categories; a sub-chronic study on a Kerosine (CAS 8008-20-6) and a chronic study on a Highly Refined Base Oil (CAS 8042-47-5). These do not contain significant amounts of the PAH constituents considered to be the drivers of toxicological hazard for VHGO, but have other constituents in common. They help to demonstrate that no significant toxicological hazard is expected from other aliphatic (paraffinic and naphthenic) and aromatic (mono- and di- aromatic) constituents.   In addition, one oral sub-chronic study is proposed on a VHGO substance containing high levels of PAH constituents.   For sub-chronic inhalation toxicity of VGOs/HGOs/Distillate fuels, a conservative sub-chronic NOAEC of 750 mg/m3 was determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of >1710 mg/m3 was established for systemic effects, based on no significant findings at this level (OECD 413).   In a subacute dermal repeated-dose toxicity test, the NOEL level based on dermal irritation was 0.0001 mL/kg and a NOEL of 0.5 mL/kg was calculated for systemic toxicity (OECD 410). For subchronic dermal toxicity, a NOAEL of 30 mg/kg body weight/day appears appropriate for VGOs/HGOs/Distillate fuels based on changes in haematological parameters (decreased RBC, haemoglobin, HCT), clinical chemistry values (increased urea nitrogen and cholesterol) parameters and organ weight effects (increased liver weight, decreased thymus weight). The NOAEL for local effects is 125 mg/kg body weight/d, based on histopathological changes present at the application site (OECD 411). In addition, a recent study to OECD 411 and GLP was conducted on a member of the VHGO category. This showed low systemic toxicity (NOAEL 600 mg/kg/day), with higher doses not possible due to excessive local irritation. This study was conducted on a substance in the category low in PAH content (the constituent expected to drive toxicological hazard). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d497e546-8047-46e2-b43f-ba42b873f0f2/documents/246ae508-16eb-446c-afd1-ad680080afdb_fbdd2c4a-4170-4eeb-90ee-ba62a8786ae9.html,,,,,, "Distillates (petroleum), light hydrocracked",64741-77-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d497e546-8047-46e2-b43f-ba42b873f0f2/documents/246ae508-16eb-446c-afd1-ad680080afdb_fbdd2c4a-4170-4eeb-90ee-ba62a8786ae9.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,30 mg/kg bw/day,,rat "Distillates (petroleum), light hydrocracked",64741-77-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d497e546-8047-46e2-b43f-ba42b873f0f2/documents/246ae508-16eb-446c-afd1-ad680080afdb_fbdd2c4a-4170-4eeb-90ee-ba62a8786ae9.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Distillates (petroleum), light hydrocracked",64741-77-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d497e546-8047-46e2-b43f-ba42b873f0f2/documents/246ae508-16eb-446c-afd1-ad680080afdb_fbdd2c4a-4170-4eeb-90ee-ba62a8786ae9.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Distillates (petroleum), light hydrocracked",64741-77-1," Acute Oral Toxicity: Acute oral toxicity of #2 home heating oil, was evaluated in male and female rats following a single oral gavage administration of the test material at different concentrations (similar to OECD 401).  The  LD50 for #2 home heating oil is 21.1 mL/kg body weight (approx 17,900 mg/kg). Based on all acute oral toxicity studies, the LD50 for VGOs/HGOs/Distillate fuels is > 5000 mg/kg bw. Acute Inhalation Toxicity: Acute inhalation toxicity of naval distillate in male and female rats was evaluated in a study involving whole-body exposure  for 4 hours (similar to OECD 403).  The acute inhalation LC50 was 4.1 mg/L . Acute Dermal Toxicity: In an acute dermal toxicity study, male and female New Zealand White rabbits were exposed to #2 home heating oil for 24 hours at a dose level of 5 mL/kg (approx 4300 mg/kg). The animals were then observed for 14 days (similar to OECD 402).  Based on this study, the acute dermal LD50 is > 4300 mg/kg.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d497e546-8047-46e2-b43f-ba42b873f0f2/documents/50ca8717-e805-460b-bb99-b647882e2c88_fbdd2c4a-4170-4eeb-90ee-ba62a8786ae9.html,,,,,, "Distillates (petroleum), light hydrocracked",64741-77-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d497e546-8047-46e2-b43f-ba42b873f0f2/documents/50ca8717-e805-460b-bb99-b647882e2c88_fbdd2c4a-4170-4eeb-90ee-ba62a8786ae9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light hydrocracked",64741-77-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d497e546-8047-46e2-b43f-ba42b873f0f2/documents/50ca8717-e805-460b-bb99-b647882e2c88_fbdd2c4a-4170-4eeb-90ee-ba62a8786ae9.html,,dermal,LD50,"4,300 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light hydrocracked",64741-77-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d497e546-8047-46e2-b43f-ba42b873f0f2/documents/50ca8717-e805-460b-bb99-b647882e2c88_fbdd2c4a-4170-4eeb-90ee-ba62a8786ae9.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "2,3-epoxypropyl o-tolyl ether",2210-79-9," 2,3 epoxypropyl o-tolyl ether was investigated for systemic toxicity in an OECD 408 ""Subchronic Oral Toxicity - Rodent: 90 Day Study” in the rat. The test item was administered by gavage to three groups, each of ten male and ten female Wistar Han™:RccHan™:WIST strain rats, for up to ninety consecutive days, at dose levels of 30, 100 and 600 mg/kg bw/day. Based on the results of this study, the NOAEL was 600 mg/kg bw/day for both sexes.  There were some findings on the study were either sporadic and did not reflect an association with the dose of test substance, or were secondary effects caused by the irritant properties of the test substance.   The test substance, 2,3-epoxypropyl o-tolyl ether was accessed for potential adverse effects in an O.E.C.D. test guideline no 412 four-week vapor inhalation study in rats at the maximum achievable vapor concentration of 4 ppm. Also, a 21-day head-only exposure aerosol inhalation study was conducted up to a high concentration of approximately 305 mg/m3 in the rat.. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6058b595-7ddc-44a2-8ef0-8a29e4b401c3/documents/IUC5-ce352fb7-6005-4727-af63-e963e552772b_311e5764-1d72-4121-8bd5-05cb6a9e833b.html,,,,,, "2,3-epoxypropyl o-tolyl ether",2210-79-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6058b595-7ddc-44a2-8ef0-8a29e4b401c3/documents/IUC5-ce352fb7-6005-4727-af63-e963e552772b_311e5764-1d72-4121-8bd5-05cb6a9e833b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat "2,3-epoxypropyl o-tolyl ether",2210-79-9,"The acute oral toxicity of the test substance, 2,3-epoxypropyl o-tolyl ether, was accessed in three independent rat studies. The test substance was evaluated in an O.E.C.D. test guideline no. 403 rat four hour Acute Inhalation study. The acute aerosol inhalation toxicity of the tst substance was also evaluated in a rat, nose-only four hour study. Acute dermal toxicity was evaluated in two independent rat 24 hr exposure studies and a rabbit 24 hour study.. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6058b595-7ddc-44a2-8ef0-8a29e4b401c3/documents/IUC5-489a0936-619b-4975-8257-e935f7fb7bb2_311e5764-1d72-4121-8bd5-05cb6a9e833b.html,,,,,, "2,3-epoxypropyl o-tolyl ether",2210-79-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6058b595-7ddc-44a2-8ef0-8a29e4b401c3/documents/IUC5-489a0936-619b-4975-8257-e935f7fb7bb2_311e5764-1d72-4121-8bd5-05cb6a9e833b.html,,inhalation,LC50,"6,090 mg/m3",adverse effect observed, "Distillates (petroleum), solvent-refined light naphthenic",64741-97-5,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/88597428-4d63-4bfc-8ede-f1040bc56f83/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_4900347b-85cc-4cb1-be9b-b2ca3a3416e0.html,,,,,, "Distillates (petroleum), solvent-refined light naphthenic",64741-97-5,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/88597428-4d63-4bfc-8ede-f1040bc56f83/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_4900347b-85cc-4cb1-be9b-b2ca3a3416e0.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Distillates (petroleum), solvent-refined light naphthenic",64741-97-5,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/88597428-4d63-4bfc-8ede-f1040bc56f83/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_4900347b-85cc-4cb1-be9b-b2ca3a3416e0.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Distillates (petroleum), solvent-refined light naphthenic",64741-97-5,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/88597428-4d63-4bfc-8ede-f1040bc56f83/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_4900347b-85cc-4cb1-be9b-b2ca3a3416e0.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Distillates (petroleum), solvent-refined light naphthenic",64741-97-5,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88597428-4d63-4bfc-8ede-f1040bc56f83/documents/73761dae-46d6-428e-8e40-e5cc70088d96_4900347b-85cc-4cb1-be9b-b2ca3a3416e0.html,,,,,, "Distillates (petroleum), solvent-refined light naphthenic",64741-97-5,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88597428-4d63-4bfc-8ede-f1040bc56f83/documents/73761dae-46d6-428e-8e40-e5cc70088d96_4900347b-85cc-4cb1-be9b-b2ca3a3416e0.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), solvent-refined light naphthenic",64741-97-5,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88597428-4d63-4bfc-8ede-f1040bc56f83/documents/73761dae-46d6-428e-8e40-e5cc70088d96_4900347b-85cc-4cb1-be9b-b2ca3a3416e0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), solvent-refined light naphthenic",64741-97-5,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88597428-4d63-4bfc-8ede-f1040bc56f83/documents/73761dae-46d6-428e-8e40-e5cc70088d96_4900347b-85cc-4cb1-be9b-b2ca3a3416e0.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Ethylene oxide,75-21-8,"Repeated dose toxicity: oral In 1956, Hollingworth et al briefly reported on a subacute gavage study in rats and this information is assigned a validity score of 4. A twenty-one-day exposure resulted in irritation of the stomach, effects on body weight and liver at 100 mg/kg bw. Local adverse effects on the stomach after gavage dosing are consistent with the corrosivity. Adverse findings were not reported for the lower dosages (3 and 30 mg/kg bw.).   Repeated dose toxicity: inhalation Snellings et al. (1984) conducted a subchronic study in 30 B6C3F1 mice per sex per dose which was equivalent or similar to OECD 413 with deviations concerning the exposure time of 10 and 11 weeks. GLP compliance was not specified. Male and female animals were given concentrations of 10, 50, 100 and 250 ppm for 6 hours per day and 5 days per week for a study duration of 10 and 11 weeks for males and females, respectively. No mortality was observed. A dose-related trend of response in the 250, 100, and 50 ppm exposure groups was noted in the evaluation of locomotor functions; however, because of the small sample size, determination of what concentrations were effect or no-effect levels is difficult. The NOAEC was found to be 10 ppm (equivalent to 18 mg/m3) for male and female mice.   Bushy Run Research Centre (1982) conducted a subchronic GLP-conform study in 35 Fischer 344 rats per sex per dose and 15 CD1 and CF1 mice per sex per dose which was equivalent or similar to OECD 413 with deviations concerning the exposure time of 7 and 8 weeks. The animals were given vapour concentrations of 50, 100, 150, and 450 ppm (equivalent to 91, 183, 275, and 824 mg/m3) for 6 hours per day and 5 days per week over a study period of 7 - 8 weeks. Within 2 to 3 weeks, high numbers of mortalities and other significant treatment-related effects for both rats and mice occurred at the 450 ppm exposure level. Before death occurred in rats and mice of this exposure group, observations of tremors, convulsions, and paresis of the hindquarters were observed in several animals. Although there was no clear pathogenesis, the most probable cause of death for the rats was vascular damage or nasal cavity obstruction. Histologic changes noted for the rats of the 450 ppm concentration group, which were sacrificed after 2 or 3 weeks of exposure, were various lesions in the nasal cavity mucosa, lymphoid tissue atrophy, and testicular degeneration. Transient depression in the rats of gain in body weight was observed for male rats and male mice exposed to concentrations as low as 50 ppm of ethylene oxide. Only a few significant findings in organ weight determinations and clinical pathology values were noted in the rats of the 150 ppm exposure level; however, none of these were supported by histopathologic alterations. A NOAEC was not established.   Lynch et al. (1984) performed a chronic non-guideline, non-GLP study in 60 adult male monkeys. The animals were exposed to vapour concentrations of 50 and 100 ppm for 7 hours per day and 5 days per week over a study period of 2 years. The 100 ppm group had a statistically significant reduced mean body weight compared to the control group beginning at week 19 and continuing through week 104. Five monkeys died during the 2-year exposures, one each in the ethylene oxide 50 and 100 ppm groups. These deaths did not appear to be related to oxide exposure. However, a NOAEC was not determined.   Matsuoka et al. (1990) exposed rats to 500 ppm ethylene oxide for six hours a day, three times a week in a subchronic non guideline study. The focus of the study was on creatinine kinase but also several other parameters were assessed. After 12 weeks exposure, there were no alterations in serum triiodothyronine, thyroxine, and thyroid stimulating hormone, showing that thyroid function was not impaired by exposure to EO. Body weight did not differ between exposed and control groups. However, the exposed rats began to show ataxic gait at the sixth week of the experiment.  The creatine kinase (CK) activity in the serum was lowered by more than 40% after 12 weeks of exposure. Serum triglyceride levels decreased by 20%, but no other biochemical alterations were found. The CK activity was also inhibited in brain, spinal cord, and muscle after four weeks exposure but no inhibition was found in ASAT and LDH from these tissues. After 12 weeks exposure, CK activity in the brain was more suppressed than after four weeks. After a single exposure (six hours), CK in the brain was suppressed by approximately 10%. The enzyme activity recovered gradually with time. Haematolegical exarnination revealed normocytic and normochromic anemia, Liver and renal functions were normal, The cytochrome P450 enzyme systern in the lung and brain were not affected, However, hepatic cytochrome P-450 and protoheme dccreased by 28% ancl 19%, respectively. Hepatic tetal microsomal protein, cytochrome bs, NADPH-cytochrome c rcductase and NADHferricyanidereductase were not affected. The activity of hepatic heme oxygenase showed a2-fold increase, These results suggest that the heme moiety of hepatic cytochrome P450 was primarily attacked by exposure of ethylene oxide and the cellular heme balance in liver was aitered. Repeated dose toxicity: dermal No study available for systemic effects upon repeated dermal exposure. The substance is corrosive to skin and a skin sensitizer. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Scientifically acceptable data available. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6e34891-366b-4da4-8ab3-e5aa60035878/documents/IUC5-58473e86-4e47-4aeb-a368-d4e0edf8cb43_f837c06d-0c41-4c52-9f65-36adee236398.html,,,,,, Ethylene oxide,75-21-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6e34891-366b-4da4-8ab3-e5aa60035878/documents/IUC5-58473e86-4e47-4aeb-a368-d4e0edf8cb43_f837c06d-0c41-4c52-9f65-36adee236398.html,Chronic toxicity – systemic effects,inhalation,NOAEC,18 mg/m3,,rat Ethylene oxide,75-21-8," Acute oral toxicity: Smyth et al. (1941): non-guideline, non-GLP study in rat and guinea-pig, non-specified dose levels applied as a 1% aqueous solution. LD50 (male rats): 330.0 mg/kg bw. For male and female guinea pigs, LD50 was 270 mg/kg bw. Hollingsworth et al. (1956): non-guideline, non-GLP in rats exposed to 100 and 200 mg/kg bw. LD0: 100 mg/kg bw, LD100: 200 mg/kg bw. Acute inhalation toxicity: US NTP (1987): Similar to OECD 403, whole-body exposure, GLP unspecified, 5 mice per dose and sex exposed for 4h at dose levels between 100 and 1600 ppm. The lowest LC50 value was 660 ppm (95% CI 509-856 ppm) as calculated for female mice. This corresponds to 1189 mg/m3 air. Snellings et al. (2011): non-guideline, GLP, using 5 rats per sex per dose exposed for 4-h at dose levels between 1443 ppm – 2182 ppm. The LC50 was established to be 2767.0 mg/m³ and 3550.0 mg/m³ for female and male rats, respectively. Acute dermal toxicity: No experimental study is available. However, extensive skin burns with blister formation have been described as the result of exposure to aqueous solutions; this effect has been repeatedly observed over many years by physicians working in the industry. Excessive skin burns are also reported in animal studies and ethylene oxide is classified for corrosivity to skin. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6e34891-366b-4da4-8ab3-e5aa60035878/documents/IUC5-2ec8ac50-64d6-4de7-bdf9-3cb91172509b_f837c06d-0c41-4c52-9f65-36adee236398.html,,,,,, Ethylene oxide,75-21-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6e34891-366b-4da4-8ab3-e5aa60035878/documents/IUC5-2ec8ac50-64d6-4de7-bdf9-3cb91172509b_f837c06d-0c41-4c52-9f65-36adee236398.html,,oral,LD50,270 mg/kg bw,adverse effect observed, Ethylene oxide,75-21-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6e34891-366b-4da4-8ab3-e5aa60035878/documents/IUC5-2ec8ac50-64d6-4de7-bdf9-3cb91172509b_f837c06d-0c41-4c52-9f65-36adee236398.html,,inhalation,LC50,"1,189 mg/m3",adverse effect observed, "Gas oils (petroleum), thermal-cracked, hydrodesulfurized",92045-29-9,"No repeat dose toxicity studies have been identified for cracked gas oils, following inhalation or oral exposure. The sub-chronic inhalation study of diesel fuel (OECD 413, a read-across study from VGO/HGO/Distillate Fuels) resulted in a conservative sub-chronic NOAEC of 0.88 mg/L determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of ≥1.71 mg/L was established for systemic effects, based on no significant findings at this level.In a 28-day sub-acute study (OECD 410), dermal exposure to a light catalytically cracked distillate resulted in limited systemic changes and a NOAEL of 500 mg/kg body weight/day.  In a 90-day sub-chronic study (OECD 411), dermal exposure to light catalytically cracked distillate resulted in a systemic NOAEL of 25 mg/kg body weight/day for males, and 125 mg/kg body weight/day for females, based upon reductions in thymus weight.  In another 90-day sub-chronic study (OECD 411), dermal exposure to coker light gas oil resulted in a systemic LOAEL of 30 mg/kg body weight/day for males and females, based upon clinical signs and irritation noted at all doses. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3981c11e-059c-491c-a696-1f3525d8ec94/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_ef8f37b9-0ca1-41f2-81b5-58f98ea72e28.html,,,,,, "Gas oils (petroleum), thermal-cracked, hydrodesulfurized",92045-29-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3981c11e-059c-491c-a696-1f3525d8ec94/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_ef8f37b9-0ca1-41f2-81b5-58f98ea72e28.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,25 mg/kg bw/day,,rat "Gas oils (petroleum), thermal-cracked, hydrodesulfurized",92045-29-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3981c11e-059c-491c-a696-1f3525d8ec94/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_ef8f37b9-0ca1-41f2-81b5-58f98ea72e28.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Gas oils (petroleum), thermal-cracked, hydrodesulfurized",92045-29-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3981c11e-059c-491c-a696-1f3525d8ec94/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_ef8f37b9-0ca1-41f2-81b5-58f98ea72e28.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Gas oils (petroleum), thermal-cracked, hydrodesulfurized",92045-29-9,"Acute Oral Toxicity:Acute oral toxicity of cracked gas oils was evaluated in male and female rats by a single oral gavage administration of a dose ranging from 2050 to 6250 mg/kg body weight.  Based on mortality and toxicity findings, an oral LD50 of 4660 mg/kg body weight and 3200 mg/kg body weight were reported for males and females, respectively.  Acute Inhalation Toxicity:Acute inhalation toxicity of cracked gas oils in rats was evaluated via whole-body exposure to test material at various measured concentrations for 4 hours.  The acute inhalation LC50 was 4.65 mg/L in males and females. Acute Dermal Toxicity:Acute dermal toxicity of cracked gas oils was evaluated in male and female rabbits at a single dose of 2000 mg/kg body weight.  Based on a lack of adverse systemic effects or mortality, the acute dermal LD50 for light catalytically cracked distillate was >2000 mg/kg body weight.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3981c11e-059c-491c-a696-1f3525d8ec94/documents/61f4e539-9411-462c-acca-769cdd71de1b_ef8f37b9-0ca1-41f2-81b5-58f98ea72e28.html,,,,,, "Gas oils (petroleum), thermal-cracked, hydrodesulfurized",92045-29-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3981c11e-059c-491c-a696-1f3525d8ec94/documents/61f4e539-9411-462c-acca-769cdd71de1b_ef8f37b9-0ca1-41f2-81b5-58f98ea72e28.html,,oral,LD50,"3,200 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), thermal-cracked, hydrodesulfurized",92045-29-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3981c11e-059c-491c-a696-1f3525d8ec94/documents/61f4e539-9411-462c-acca-769cdd71de1b_ef8f37b9-0ca1-41f2-81b5-58f98ea72e28.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), thermal-cracked, hydrodesulfurized",92045-29-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3981c11e-059c-491c-a696-1f3525d8ec94/documents/61f4e539-9411-462c-acca-769cdd71de1b_ef8f37b9-0ca1-41f2-81b5-58f98ea72e28.html,,inhalation,LC50,"4,650 mg/m3",adverse effect observed, Tetrachloroethylene,127-18-4,"The critical effects of tetrachloroethylene are kidney, liver and central nervous system effects. Based on all available data, there is no clear evidence from studies in humans for repeated dose effects of tetrachloroethylene at exposure levels up to a level of 20 ppm (138 mg/m3) (8 hr TWA).Regarding oral exposure, no human data are available. Regarding animal data, an oral LOAEL of 390 mg/kg bw/day has been identified from the mouse oral cancer bioassay based on kidney damage. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fe8743a-d29d-4f2e-8d49-644139867760/documents/IUC5-430c594f-cff4-41a2-bf29-5c7108924ec7_0d7b8cfc-1b5a-41f7-94e5-a8bd41d4f53a.html,,,,,, Tetrachloroethylene,127-18-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fe8743a-d29d-4f2e-8d49-644139867760/documents/IUC5-430c594f-cff4-41a2-bf29-5c7108924ec7_0d7b8cfc-1b5a-41f7-94e5-a8bd41d4f53a.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,138 mg/m3,, Tetrachloroethylene,127-18-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fe8743a-d29d-4f2e-8d49-644139867760/documents/IUC5-430c594f-cff4-41a2-bf29-5c7108924ec7_0d7b8cfc-1b5a-41f7-94e5-a8bd41d4f53a.html,Chronic toxicity – systemic effects,oral,LOAEL,390 mg/kg bw/day,,mouse Tetrachloroethylene,127-18-4,"  The oral and dermal LD50 values and the inhalation LC50 values indicate that the acute toxicity of tetrachloroethylene is low. In animals, as in humans, the main signs of acute inhalation toxicity are indicative of CNS depression. A concentration of 40 ppm (275 mg/m3) is concluded to be a concentration without the occurrence of these effects in humans. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fe8743a-d29d-4f2e-8d49-644139867760/documents/IUC5-17bdfe4b-9e52-4024-8417-6099b32d6099_0d7b8cfc-1b5a-41f7-94e5-a8bd41d4f53a.html,,,,,, Tetrachloroethylene,127-18-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fe8743a-d29d-4f2e-8d49-644139867760/documents/IUC5-17bdfe4b-9e52-4024-8417-6099b32d6099_0d7b8cfc-1b5a-41f7-94e5-a8bd41d4f53a.html,,inhalation,,275 mg/m3,, "Hydrocarbons, C3-4-rich, petroleum distillate",68512-91-4,"Only one stream (Liquified Petroleum Gases CAS 68476 -85 -7) of the Other Petroleum Gases category has been tested but this and the main constituents of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and humans. The mammalian toxicity effects of this category will be driven by the content of benzene if the latter is present at levels of >10%. Additionally, the category may contain carbon monoxide which could trigger classification.   ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1f84a4f-54dd-46f4-8cb0-ae874655fcc0/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_904e9f29-6aa9-4f4b-a359-33ff7f520732.html,,,,,, "Hydrocarbons, C3-4-rich, petroleum distillate",68512-91-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1f84a4f-54dd-46f4-8cb0-ae874655fcc0/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_904e9f29-6aa9-4f4b-a359-33ff7f520732.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"7,214 mg/m3",,rat "Hydrocarbons, C3-4-rich, petroleum distillate",68512-91-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1f84a4f-54dd-46f4-8cb0-ae874655fcc0/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_904e9f29-6aa9-4f4b-a359-33ff7f520732.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"8,600 mg/m3",adverse effect observed,rat "Hydrocarbons, C3-4-rich, petroleum distillate",68512-91-4,"Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the constituents. Across species, main constituent gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene in streams where it is present at levels of <1%. However, some streams in this category may contain benzene levels >1% or carbon monoxide which could trigger classification. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1f84a4f-54dd-46f4-8cb0-ae874655fcc0/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_904e9f29-6aa9-4f4b-a359-33ff7f520732.html,,,,,, "Hydrocarbons, C3-4-rich, petroleum distillate",68512-91-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1f84a4f-54dd-46f4-8cb0-ae874655fcc0/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_904e9f29-6aa9-4f4b-a359-33ff7f520732.html,,inhalation,LC50,"22,948 mg/m3",no adverse effect observed, "1,3-propanesultone",1120-71-4," Waiving of short-term (28 days) repeated dose toxicity study due to available chronic toxicity studies according to the REACH legal text Annex VIII: ""Standard information requirements for substances manufactured or imported in quantities of 10 tonnes or more"", Column 2. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1faaf60e-d506-45c6-8edd-2ffe4c89c215/documents/0e4a71de-99ea-4056-ae27-c4ff6ffd75b1_73eb05b9-bfe9-459e-b2d9-b8eaf85a5e56.html,,,,,, "1,3-propanesultone",1120-71-4,"The LD50 value in the rat derived from the key oral acute toxicity study with 1,3-propanesultone is 100 - 200 mg/kg bw. After 6 h inhalation exposure the LC50 in rats was approximately 1.7 mg/L air. After a single dermal application of 830 mg/kg bw to mice 15% of the animals died (LD15). For the rabbit and guinea pig a dermal LD50 of 660 mg/kg bw and 700 - 1400 mg/kg bw has been reported, respectively. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1faaf60e-d506-45c6-8edd-2ffe4c89c215/documents/a26b2363-e5f3-4b5a-88b1-a6fbc08aee36_73eb05b9-bfe9-459e-b2d9-b8eaf85a5e56.html,,,,,, "1,3-propanesultone",1120-71-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1faaf60e-d506-45c6-8edd-2ffe4c89c215/documents/a26b2363-e5f3-4b5a-88b1-a6fbc08aee36_73eb05b9-bfe9-459e-b2d9-b8eaf85a5e56.html,,oral,LD50,100 mg/kg bw,adverse effect observed, "1,3-propanesultone",1120-71-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1faaf60e-d506-45c6-8edd-2ffe4c89c215/documents/a26b2363-e5f3-4b5a-88b1-a6fbc08aee36_73eb05b9-bfe9-459e-b2d9-b8eaf85a5e56.html,,dermal,LD50,660 mg/kg bw,adverse effect observed, "1,3-propanesultone",1120-71-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1faaf60e-d506-45c6-8edd-2ffe4c89c215/documents/a26b2363-e5f3-4b5a-88b1-a6fbc08aee36_73eb05b9-bfe9-459e-b2d9-b8eaf85a5e56.html,,inhalation,LC50,"1,700 mg/m3",adverse effect observed, Bis(2-chloroethyl) ether,111-44-4," For Bis(2-chloroethyl) ether, a NOAEL of 15 mg/kg bw/day for oral exposure was established based on a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test performed in rat according to OECD Guideline N°422 under GLP (reliability 1). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/155d9059-ca89-4013-917c-bf97baffe887/documents/23519bb7-536a-4e16-95a7-3c333656acfe_f888d0de-81ab-4f64-b07a-64a6e059b8f5.html,,,,,, Bis(2-chloroethyl) ether,111-44-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/155d9059-ca89-4013-917c-bf97baffe887/documents/23519bb7-536a-4e16-95a7-3c333656acfe_f888d0de-81ab-4f64-b07a-64a6e059b8f5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat Bis(2-chloroethyl) ether,111-44-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/155d9059-ca89-4013-917c-bf97baffe887/documents/23519bb7-536a-4e16-95a7-3c333656acfe_f888d0de-81ab-4f64-b07a-64a6e059b8f5.html,Chronic toxicity – systemic effects,inhalation,LOAEC,403.6 mg/m3,,rat Bis(2-chloroethyl) ether,111-44-4," 1. Acute toxicity via the oral route: Acute toxicity data following administration by the orale route were identified in three publications. Most data originate from pre-GLP studies and data on post-exposure observations are limited. The lowest mammalian LD50 was reported by Smyth (J. Ind Hyg. Toxicol., 1948, 30(1):63-8). In this studies, the rat LD50 was found to be 75 mg/kg bw. In Drake & Myer (1990), a synthetic summary of an acute oral toxicity study on mice and rats is reported. The rat LD50 (male/female) was found to be 144 mg/kg bw, while a mice LD50 (male/female) of 211 mg/kg bw is reported. In both cases, deaths occurred in the first days following exposure (by day 3 for rats and day 5 for mice). Exposure to Bis(2-chloroethyl) ether did not induce any remarkable changes in body weight nor any visible abnormalities in any surviving rats at study termination. Pharmacotoxic signs observed in rats included ptosis, increased salivation, mucoid diarrhea, soft stool, anogenital staining and decreased activity. In mice, low carriage, decreased activity, ataxia, tremors and anogenital staining was observed. No details on organ necropsy of histological examionation were reported. Other mammalian LD50 data were published in Spector (1956). These data originate from unpublished studies by Smyth. Rat, mice and rabbit LD50 were found to be 105, 136 and 126 mg/kg bw. Taken together, these data suggest that their is no marked differences in the sensitivity of these species towards the toxicity of Bis(2-chloroethyl) ether after oral administration. 2. Acute toxicity via the inhalation route: All available data related to the acute toxicity through the inhalation route of bis(2-chloroethyl) ether were generated in published pre-GLP studies. The lowest reliable LD50 values were published in a data book from the USSR State Committee for Science and Technology and republished in English by UNEP (Izmerov, 1982). The methodology used to acquire these data is not detailed. In rats, the LC50 following a 4 hour exposure to mist of Bis(2-chloroethyl) ether was 0.330 mg/L. The LC50 following a 2 hour exposure of mice to mist of Bis(2-chloroethyl) ether was 0.650 mg/L. Based on modified Haber's law as detailed in the Guidance on IR&CSA Section R.7.4.4.1, the mice LC50 is 0.325 mg/L when exposure duration is extrapolated to 4h. Both rats and mice LD50 data classify Bis(2-chloroethyl) ether in the Acute Category II according to the CLP criteria. In addition, Izmerov (1982) report the fact that LOEL based on irritation of mucous membranes of upper airways estimated using vital staining of lung tissue was 0.017 mg/L in rats (unspecified exposure length) and 0.019 mg/L in rabbits (5 min exposure length). In carpenter et al. (J. Ind. Hyg. Toxicol., 1948, 31(6):343-6), 96 compounds were graded on the basis of the response of rats (6 test animals) to a 4-hour vapor exposure in a 14-day observation period. In the conditions of this test, exposure to vapour of Bis(2-chloroethyl) ether at 250 ppm led to the death of 2 to 4 animals (out of 6). No results regarding clinical signs or gross pathology are reported. Based on these observation, the LC50 is thus approximatively 250 ppm or 1.464 mg/L. In Schrenk et al. (Public Health Rep., 1933, 48(46):1389-98), the authors report that following a 4.5h exposure period to Bis(2-chloroethyl) ether, no Guinea pigs died at a vapour concentration of 0.618 mg/L while most guinea pigs died within 24h at 1.550 mg/L. In the conditions of this experiment, Bis(2 -chloroethyl) ether LC50 lies between 0.168 and 1.550 mg/L. In this study, Bis(2-chloroethyl) ether was found to be an intense irritant to the respiratory passages and lungs, causing congestion, edema, and hemorrhage of the lung, which progresses with time to, in some instances, complete consolidation, often giving rise to a delayed death 1 to 8 days after exposure. The authors concluded that the pathology of Bis(2-chloroethyl) ether was similar to that produced by other respiratory irritants, such as the acid gases. 3. Acute toxicity via the dermal route: All available data related to the acute toxicity of bis(2-chloroethyl) ether through the dermal route were generated in published pre-GLP studies. The lowest LD50 is reported by Clayton & Clayton (Patty's Indutsrial Hygiene and Toxicology, Vol. IIA (3rd revised edition), 1981, p. 2518). The data originates an internal toxicity test from Dow Chemical Co. Following exposure by skin contact to a 10 % Bis(2-chloroethyl) ether solution in propylene glycol for 24 hours, the rabbit LD50 was found to be 90 mg/kg bw. It is not stated if the reported LD50 of 90 mg/kg bw is based on the applied substance or the Bis(2-chloroethyl) ether content. As worst case scenario, it is assumed that the LD50 is based on the total applied material. Other LD50 data obtained on rabbits and guinea pigs (see ""Additional information"" for details) range between 366 and 870 mg/kg, which question the representativity and reliability of the data selected by Clayton & Clayton (1981). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/155d9059-ca89-4013-917c-bf97baffe887/documents/2db8ab3d-ca78-4af5-b317-fde9571e97c9_f888d0de-81ab-4f64-b07a-64a6e059b8f5.html,,,,,, Bis(2-chloroethyl) ether,111-44-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/155d9059-ca89-4013-917c-bf97baffe887/documents/2db8ab3d-ca78-4af5-b317-fde9571e97c9_f888d0de-81ab-4f64-b07a-64a6e059b8f5.html,,oral,LD50,75 mg/kg bw,adverse effect observed, Bis(2-chloroethyl) ether,111-44-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/155d9059-ca89-4013-917c-bf97baffe887/documents/2db8ab3d-ca78-4af5-b317-fde9571e97c9_f888d0de-81ab-4f64-b07a-64a6e059b8f5.html,,dermal,LD50,9 mg/kg bw,adverse effect observed, Bis(2-chloroethyl) ether,111-44-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/155d9059-ca89-4013-917c-bf97baffe887/documents/2db8ab3d-ca78-4af5-b317-fde9571e97c9_f888d0de-81ab-4f64-b07a-64a6e059b8f5.html,,inhalation,LC50,325 mg/m3,adverse effect observed, "Distillates (petroleum), light catalytic cracked",64741-59-9,"No repeat dose toxicity studies have been identified for cracked gas oils, following inhalation or oral exposure. The sub-chronic inhalation study of diesel fuel (OECD 413, a read-across study from VGO/HGO/Distillate Fuels) resulted in a conservative sub-chronic NOAEC of 0.88 mg/L determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of ≥1.71 mg/L was established for systemic effects, based on no significant findings at this level.In a 28-day sub-acute study (OECD 410), dermal exposure to a light catalytically cracked distillate resulted in limited systemic changes and a NOAEL of 500 mg/kg body weight/day.  In a 90-day sub-chronic study (OECD 411), dermal exposure to light catalytically cracked distillate resulted in a systemic NOAEL of 25 mg/kg body weight/day for males, and 125 mg/kg body weight/day for females, based upon reductions in thymus weight.  In another 90-day sub-chronic study (OECD 411), dermal exposure to coker light gas oil resulted in a systemic LOAEL of 30 mg/kg body weight/day for males and females, based upon clinical signs and irritation noted at all doses. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b727c544-5003-4ac4-9796-dd1068e6c3e5/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_ecf00990-1268-4954-abf3-3a1ae9198b7b.html,,,,,, "Distillates (petroleum), light catalytic cracked",64741-59-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b727c544-5003-4ac4-9796-dd1068e6c3e5/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_ecf00990-1268-4954-abf3-3a1ae9198b7b.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), light catalytic cracked",64741-59-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b727c544-5003-4ac4-9796-dd1068e6c3e5/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_ecf00990-1268-4954-abf3-3a1ae9198b7b.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Distillates (petroleum), light catalytic cracked",64741-59-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b727c544-5003-4ac4-9796-dd1068e6c3e5/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_ecf00990-1268-4954-abf3-3a1ae9198b7b.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Distillates (petroleum), light catalytic cracked",64741-59-9,"Acute Oral Toxicity:Acute oral toxicity of cracked gas oils was evaluated in male and female rats by a single oral gavage administration of a dose ranging from 2050 to 6250 mg/kg body weight.  Based on mortality and toxicity findings, an oral LD50 of 4660 mg/kg body weight and 3200 mg/kg body weight were reported for males and females, respectively.  Acute Inhalation Toxicity:Acute inhalation toxicity of cracked gas oils in rats was evaluated via whole-body exposure to test material at various measured concentrations for 4 hours.  The acute inhalation LC50 was 4.65 mg/L in males and females. Acute Dermal Toxicity:Acute dermal toxicity of cracked gas oils was evaluated in male and female rabbits at a single dose of 2000 mg/kg body weight.  Based on a lack of adverse systemic effects or mortality, the acute dermal LD50 for light catalytically cracked distillate was >2000 mg/kg body weight.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b727c544-5003-4ac4-9796-dd1068e6c3e5/documents/61f4e539-9411-462c-acca-769cdd71de1b_ecf00990-1268-4954-abf3-3a1ae9198b7b.html,,,,,, "Distillates (petroleum), light catalytic cracked",64741-59-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b727c544-5003-4ac4-9796-dd1068e6c3e5/documents/61f4e539-9411-462c-acca-769cdd71de1b_ecf00990-1268-4954-abf3-3a1ae9198b7b.html,,oral,LD50,"3,200 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light catalytic cracked",64741-59-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b727c544-5003-4ac4-9796-dd1068e6c3e5/documents/61f4e539-9411-462c-acca-769cdd71de1b_ecf00990-1268-4954-abf3-3a1ae9198b7b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light catalytic cracked",64741-59-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b727c544-5003-4ac4-9796-dd1068e6c3e5/documents/61f4e539-9411-462c-acca-769cdd71de1b_ecf00990-1268-4954-abf3-3a1ae9198b7b.html,,inhalation,LC50,"4,650 mg/m3",adverse effect observed, "Residual oils (petroleum), solvent-refined",64742-01-4,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6962c2a8-e71b-4074-aaeb-385c88cec4e3/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_feddaac1-a455-487f-9983-795846ec988f.html,,,,,, "Residual oils (petroleum), solvent-refined",64742-01-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6962c2a8-e71b-4074-aaeb-385c88cec4e3/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_feddaac1-a455-487f-9983-795846ec988f.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Residual oils (petroleum), solvent-refined",64742-01-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6962c2a8-e71b-4074-aaeb-385c88cec4e3/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_feddaac1-a455-487f-9983-795846ec988f.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Residual oils (petroleum), solvent-refined",64742-01-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6962c2a8-e71b-4074-aaeb-385c88cec4e3/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_feddaac1-a455-487f-9983-795846ec988f.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Residual oils (petroleum), solvent-refined",64742-01-4,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6962c2a8-e71b-4074-aaeb-385c88cec4e3/documents/73761dae-46d6-428e-8e40-e5cc70088d96_feddaac1-a455-487f-9983-795846ec988f.html,,,,,, "Residual oils (petroleum), solvent-refined",64742-01-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6962c2a8-e71b-4074-aaeb-385c88cec4e3/documents/73761dae-46d6-428e-8e40-e5cc70088d96_feddaac1-a455-487f-9983-795846ec988f.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Residual oils (petroleum), solvent-refined",64742-01-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6962c2a8-e71b-4074-aaeb-385c88cec4e3/documents/73761dae-46d6-428e-8e40-e5cc70088d96_feddaac1-a455-487f-9983-795846ec988f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residual oils (petroleum), solvent-refined",64742-01-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6962c2a8-e71b-4074-aaeb-385c88cec4e3/documents/73761dae-46d6-428e-8e40-e5cc70088d96_feddaac1-a455-487f-9983-795846ec988f.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "α,α,α-trichlorotoluene",98-07-7,- Acute oral toxicity: LD 50 = 1590 mg / kg bw for female and 2188 mg / kg bw for male ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc93410b-d867-476b-a70e-06bc103849f0/documents/IUC5-902b7483-84ad-4cd2-b47a-f4ef99be740e_6917f877-6934-4713-b041-2fc494a3da4b.html,,,,,, "α,α,α-trichlorotoluene",98-07-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc93410b-d867-476b-a70e-06bc103849f0/documents/IUC5-902b7483-84ad-4cd2-b47a-f4ef99be740e_6917f877-6934-4713-b041-2fc494a3da4b.html,,oral,LD50,"1,590 mg/kg bw",, "1,3-dichloropropan-2-ol",96-23-1," The subchronic toxicity of 1,3-dichloro-2-propanol (1,3-DCP) was investigated in Fischer 344 rats after 13 weeks of repeated, whole-body inhalation exposure. Groups of 10 rats of each sex were exposed to 1,3-DCP vapor by whole-body inhalation exposure at concentrations of 0, 5, 20 or 80 ppm for 6 h/day, 5 days/week for 13 weeks. All of the rats were sacrificed at the end of the treatment period. During the test period, clinical signs, mortality, body weights, food consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, gross findings, organ weights and histopathology were assessed. At 80 ppm, a decrease in the body weight gain, an increase in the urine protein and leukocyte counts and an increase in the liver and kidney weights were observed in both genders. Hematological and serum biochemical investigations revealed decreases in hemoglobin (HB), hematocrit (HCT), mean corpuscular volume (MCV) and mean corpuscular HB, as well as increases in the platelet (PLT) count, serum aspartate aminotransferase and alanine aminotransferase. The number of white blood cells was significantly lower in males than in controls, but this was not the case in females. Histopathological alterations included an increase in the incidence of multifocal necrosis, inflammation, pigmentation, biliary hyperplasia and the foci of cellular alteration of the liver and chronic nephropathy and protein cast of the kidney. At 20 ppm, decreases in HCT and MCV and increases in the liver and kidney weights were observed in both genders. A decrease in the HB of females and an increase in the PLT count of females were also observed. Histopathological alterations included slight increases in the incidences of hepatic necrosis, hepatic inflammation and chronic nephropathy. At 5 ppm, we found decreases in the MCV of males and the HB of females, as well as an increase in the liver weight of both genders. In the present experimental conditions, the target organs were determined to be the liver, kidney and blood cells in rats. The no-observed-adverse-effect level was considered to be <5 ppm/6 h/day and the low- observed-adverse-effect level was believed to be 5 ppm/6 h/day in rats. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7000187c-df8c-40e7-83b8-b62300486f55/documents/4d814de4-a18a-4912-9bf4-ccfcc45bb359_6a2e37b3-e218-4bf3-b034-91643eea094d.html,,,,,, "1,3-dichloropropan-2-ol",96-23-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7000187c-df8c-40e7-83b8-b62300486f55/documents/4d814de4-a18a-4912-9bf4-ccfcc45bb359_6a2e37b3-e218-4bf3-b034-91643eea094d.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,28.4 mg/m3,,rat "1,3-dichloropropan-2-ol",96-23-1," Acute toxicity testing was waived based upon the skin corrosive classification of the substance, however the European Commison has previous reviewed existing data on the substance and assigned the following harmonised classification and labelling: Toxic if swallowed (H301) and Harmful in contact with the skin (H312). The following reliable oral toxicity values are presented in the literature: Mouse LD50 100mg/kg bw (Lewis, RL, 2005); rat LD50 110 mg/kg bw (Lewis RL, 2005) and rat LD50 140 mg/kg bw (Smyth et al, 1962), confirming the harmonised classification for oral toxicity. A single reliable dermal toxicity value is available in the literature, an LD50 of 800 mg/kg bw in rabbits (Smyth et al, 1962), which supports the harmonised classification for dermal toxicity. A harmonised classification for inhalation toxicity has not been assigned, however based upon the weight of evidence of human occupational toxicity (Shiozaki et al, 1994) and a reliable inhalation toxicity value in mice of 0.66 mg/L (Smyth et al 1962) a classification of Fatal if inhaled (H330) can reasonably be assigned. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7000187c-df8c-40e7-83b8-b62300486f55/documents/58bc0dbb-729a-4868-9e1d-e34ec7f81879_6a2e37b3-e218-4bf3-b034-91643eea094d.html,,,,,, "1,3-dichloropropan-2-ol",96-23-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7000187c-df8c-40e7-83b8-b62300486f55/documents/58bc0dbb-729a-4868-9e1d-e34ec7f81879_6a2e37b3-e218-4bf3-b034-91643eea094d.html,,oral,LD50,100 mg/kg bw,adverse effect observed, "1,3-dichloropropan-2-ol",96-23-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7000187c-df8c-40e7-83b8-b62300486f55/documents/58bc0dbb-729a-4868-9e1d-e34ec7f81879_6a2e37b3-e218-4bf3-b034-91643eea094d.html,,dermal,LD50,800 mg/kg bw,adverse effect observed, "1,3-dichloropropan-2-ol",96-23-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7000187c-df8c-40e7-83b8-b62300486f55/documents/58bc0dbb-729a-4868-9e1d-e34ec7f81879_6a2e37b3-e218-4bf3-b034-91643eea094d.html,,inhalation,LC50,660 mg/m3,adverse effect observed, 1-ethyl-1-methylpyrrolidinium bromide,69227-51-6," None of the parameters determined in this study was clearly or significantly changed due to a toxic action of the test material. The lower body weight in high dosed males cannot be given relevance due to lack of statistical significance. A changed stain of the bedding material does not represent a toxic change. No alternations which were related to the action of the test substance were noted in dosed animals. Based on this 150 mg of the test substance per kg body weight can be defined as No-Adverse-Effect-Level. Results of the corresponding dose range finding study demonstrate, that toxic doses are only slightly above the NOEL, determined in the present study. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc2c0493-644e-4c2f-b277-f270fa27f2ee/documents/d95fb536-b56e-421e-b78e-8239bb157e72_ec88270b-ad48-40aa-951d-cede878a51ab.html,,,,,, 1-ethyl-1-methylpyrrolidinium bromide,69227-51-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc2c0493-644e-4c2f-b277-f270fa27f2ee/documents/d95fb536-b56e-421e-b78e-8239bb157e72_ec88270b-ad48-40aa-951d-cede878a51ab.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat 1-ethyl-1-methylpyrrolidinium bromide,69227-51-6," Oral: LD50 (oral) of the test substance is higher than 2000 mg/kg b.w in both sexes of rats. A claculation revealed a LD50 of about 2700 mg/kg b.w. Specific toxic effects of the test substance are gastric irritation, circulatory problems and convulsions. Dermal: All animles survived until termination. No toxicological signs were observed during the test and  obervations which were  noted were not of toxicological importance. Therefore LD50 of the test substance was > 2000 mg/kg b.w ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc2c0493-644e-4c2f-b277-f270fa27f2ee/documents/6658db50-9e19-4425-9236-76a06b1782d3_ec88270b-ad48-40aa-951d-cede878a51ab.html,,,,,, 1-ethyl-1-methylpyrrolidinium bromide,69227-51-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc2c0493-644e-4c2f-b277-f270fa27f2ee/documents/6658db50-9e19-4425-9236-76a06b1782d3_ec88270b-ad48-40aa-951d-cede878a51ab.html,,oral,LD50,"2,700 mg/kg bw",no adverse effect observed, 1-ethyl-1-methylpyrrolidinium bromide,69227-51-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc2c0493-644e-4c2f-b277-f270fa27f2ee/documents/6658db50-9e19-4425-9236-76a06b1782d3_ec88270b-ad48-40aa-951d-cede878a51ab.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), solvent-refined light paraffinic",64741-89-5,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b26aee4b-27b5-4186-ab15-b5cf9acd54a8/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_d3a30ac5-5d58-4b6e-be8c-d7dc94d0f5c3.html,,,,,, "Distillates (petroleum), solvent-refined light paraffinic",64741-89-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b26aee4b-27b5-4186-ab15-b5cf9acd54a8/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_d3a30ac5-5d58-4b6e-be8c-d7dc94d0f5c3.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Distillates (petroleum), solvent-refined light paraffinic",64741-89-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b26aee4b-27b5-4186-ab15-b5cf9acd54a8/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_d3a30ac5-5d58-4b6e-be8c-d7dc94d0f5c3.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Distillates (petroleum), solvent-refined light paraffinic",64741-89-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b26aee4b-27b5-4186-ab15-b5cf9acd54a8/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_d3a30ac5-5d58-4b6e-be8c-d7dc94d0f5c3.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Distillates (petroleum), solvent-refined light paraffinic",64741-89-5,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b26aee4b-27b5-4186-ab15-b5cf9acd54a8/documents/73761dae-46d6-428e-8e40-e5cc70088d96_d3a30ac5-5d58-4b6e-be8c-d7dc94d0f5c3.html,,,,,, "Distillates (petroleum), solvent-refined light paraffinic",64741-89-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b26aee4b-27b5-4186-ab15-b5cf9acd54a8/documents/73761dae-46d6-428e-8e40-e5cc70088d96_d3a30ac5-5d58-4b6e-be8c-d7dc94d0f5c3.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), solvent-refined light paraffinic",64741-89-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b26aee4b-27b5-4186-ab15-b5cf9acd54a8/documents/73761dae-46d6-428e-8e40-e5cc70088d96_d3a30ac5-5d58-4b6e-be8c-d7dc94d0f5c3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), solvent-refined light paraffinic",64741-89-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b26aee4b-27b5-4186-ab15-b5cf9acd54a8/documents/73761dae-46d6-428e-8e40-e5cc70088d96_d3a30ac5-5d58-4b6e-be8c-d7dc94d0f5c3.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Residues (petroleum), steam-cracked",64742-90-1,"Repeated dose toxicity data are not available for Fuel Oils streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene - when present at 10%). The available data on the marker constituent DCPD do not reveal any specific target organ toxicity of a severity that would warrant classification. Therefore, no classification or labelling is warranted for streams which only contain these components. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb4c608a-77d1-4da9-896f-10c679294acd/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_ab8d34a2-cc04-4120-a71b-2e134aee82cf.html,,,,,, "Residues (petroleum), steam-cracked",64742-90-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb4c608a-77d1-4da9-896f-10c679294acd/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_ab8d34a2-cc04-4120-a71b-2e134aee82cf.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Residues (petroleum), steam-cracked",64742-90-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb4c608a-77d1-4da9-896f-10c679294acd/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_ab8d34a2-cc04-4120-a71b-2e134aee82cf.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Residues (petroleum), steam-cracked",64742-90-1,"Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen.The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene.   Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene.   Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene. Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb4c608a-77d1-4da9-896f-10c679294acd/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_ab8d34a2-cc04-4120-a71b-2e134aee82cf.html,,,,,, "Residues (petroleum), steam-cracked",64742-90-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb4c608a-77d1-4da9-896f-10c679294acd/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_ab8d34a2-cc04-4120-a71b-2e134aee82cf.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), steam-cracked",64742-90-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb4c608a-77d1-4da9-896f-10c679294acd/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_ab8d34a2-cc04-4120-a71b-2e134aee82cf.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), steam-cracked",64742-90-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb4c608a-77d1-4da9-896f-10c679294acd/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_ab8d34a2-cc04-4120-a71b-2e134aee82cf.html,,inhalation,LC50,"1,600 mg/m3",no adverse effect observed, "Naphtha (petroleum), heavy thermal cracked",64741-83-9,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/68c4ab09-6c6d-445f-af02-97cc4f558b05/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_51bd0aac-9dc9-4bfb-8352-23b01b30a571.html,,,,,, "Naphtha (petroleum), heavy thermal cracked",64741-83-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/68c4ab09-6c6d-445f-af02-97cc4f558b05/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_51bd0aac-9dc9-4bfb-8352-23b01b30a571.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), heavy thermal cracked",64741-83-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/68c4ab09-6c6d-445f-af02-97cc4f558b05/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_51bd0aac-9dc9-4bfb-8352-23b01b30a571.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), heavy thermal cracked",64741-83-9," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68c4ab09-6c6d-445f-af02-97cc4f558b05/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_51bd0aac-9dc9-4bfb-8352-23b01b30a571.html,,,,,, "Naphtha (petroleum), heavy thermal cracked",64741-83-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68c4ab09-6c6d-445f-af02-97cc4f558b05/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_51bd0aac-9dc9-4bfb-8352-23b01b30a571.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), heavy thermal cracked",64741-83-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68c4ab09-6c6d-445f-af02-97cc4f558b05/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_51bd0aac-9dc9-4bfb-8352-23b01b30a571.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), heavy thermal cracked",64741-83-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68c4ab09-6c6d-445f-af02-97cc4f558b05/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_51bd0aac-9dc9-4bfb-8352-23b01b30a571.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Distillates (petroleum), C6-rich",93165-19-6,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e8929a5-450f-4da1-a34d-485a9b8c5557/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_a1c6d7c0-ffed-49a3-b4f3-cf1376b64a82.html,,,,,, "Distillates (petroleum), C6-rich",93165-19-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e8929a5-450f-4da1-a34d-485a9b8c5557/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_a1c6d7c0-ffed-49a3-b4f3-cf1376b64a82.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Distillates (petroleum), C6-rich",93165-19-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e8929a5-450f-4da1-a34d-485a9b8c5557/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_a1c6d7c0-ffed-49a3-b4f3-cf1376b64a82.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Distillates (petroleum), C6-rich",93165-19-6," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e8929a5-450f-4da1-a34d-485a9b8c5557/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_a1c6d7c0-ffed-49a3-b4f3-cf1376b64a82.html,,,,,, "Distillates (petroleum), C6-rich",93165-19-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e8929a5-450f-4da1-a34d-485a9b8c5557/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_a1c6d7c0-ffed-49a3-b4f3-cf1376b64a82.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), C6-rich",93165-19-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e8929a5-450f-4da1-a34d-485a9b8c5557/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_a1c6d7c0-ffed-49a3-b4f3-cf1376b64a82.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), C6-rich",93165-19-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e8929a5-450f-4da1-a34d-485a9b8c5557/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_a1c6d7c0-ffed-49a3-b4f3-cf1376b64a82.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "N,N-dimethylformamide",68-12-2," Repeated dose toxicity oral: BASF AG, 1977, Repeated dose 28-day oral gavage study in rats, 238, 475, 950, 1900 mg/kg in water, comparable to the OECD TG 407. NOAEL = 238 mg/kg bw (both sexes). Repeated dose toxicity dermal: data can be waived from oral or inhalation studies; Repeated dose toxicity inhalation: Malley et al., 1994. Chronic toxicity/oncogenicity of dimethylformamide in rats and mice following inhalation exposure; according to the OECD TG 451, NOAEC = 80 mg/m³ ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/943f1943-e399-43da-84ac-78bbd270e8d0/documents/IUC5-f24ebfdc-60db-4061-8040-58c7a5068595_37c874a7-6ad7-4587-8144-d073ba4e308f.html,,,,,, "N,N-dimethylformamide",68-12-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/943f1943-e399-43da-84ac-78bbd270e8d0/documents/IUC5-f24ebfdc-60db-4061-8040-58c7a5068595_37c874a7-6ad7-4587-8144-d073ba4e308f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,238 mg/kg bw/day,,rat "N,N-dimethylformamide",68-12-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/943f1943-e399-43da-84ac-78bbd270e8d0/documents/IUC5-f24ebfdc-60db-4061-8040-58c7a5068595_37c874a7-6ad7-4587-8144-d073ba4e308f.html,Chronic toxicity – systemic effects,inhalation,NOAEC,80 mg/m3,,other:mouse and rat "N,N-dimethylformamide",68-12-2," Acute toxicity oral: BASF AG, 1972: comparable to OECD TG 401, rats, 1504, 1880, 2350, 3008, and 3760 and 6016 mg/kg bw/day. LD50 = 3010 mg/kg bw. Acute toxicity dermal: TSCATS: OTS 0516779; comparable to OECD TG 402, rats, limit test. LD50 > 3160 mg/kg bw.   Acute toxicity inhalation: BASF AG, 1979: comparable to OECD TG 403, 2.23, 4.92, 5.10, 5.85 mg/L. LC50 > 5.85 mg/L equal, 5850 mg/m³ ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/943f1943-e399-43da-84ac-78bbd270e8d0/documents/IUC5-ccbe9f33-f675-4213-843c-957c363f5149_37c874a7-6ad7-4587-8144-d073ba4e308f.html,,,,,, "N,N-dimethylformamide",68-12-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/943f1943-e399-43da-84ac-78bbd270e8d0/documents/IUC5-ccbe9f33-f675-4213-843c-957c363f5149_37c874a7-6ad7-4587-8144-d073ba4e308f.html,,oral,LD50,"3,010 mg/kg bw",no adverse effect observed, "N,N-dimethylformamide",68-12-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/943f1943-e399-43da-84ac-78bbd270e8d0/documents/IUC5-ccbe9f33-f675-4213-843c-957c363f5149_37c874a7-6ad7-4587-8144-d073ba4e308f.html,,dermal,LD50,"3,160 mg/kg bw",adverse effect observed, "N,N-dimethylformamide",68-12-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/943f1943-e399-43da-84ac-78bbd270e8d0/documents/IUC5-ccbe9f33-f675-4213-843c-957c363f5149_37c874a7-6ad7-4587-8144-d073ba4e308f.html,,inhalation,LC50,"5,850 mg/m3",adverse effect observed, "Naphtha (petroleum), full-range alkylate, butane-contg.",68527-27-5,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c0800f3-4bfa-46cb-b367-09b10a1ee437/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_5e538aaf-9686-4107-a95e-1df5f89a921e.html,,,,,, "Naphtha (petroleum), full-range alkylate, butane-contg.",68527-27-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c0800f3-4bfa-46cb-b367-09b10a1ee437/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_5e538aaf-9686-4107-a95e-1df5f89a921e.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), full-range alkylate, butane-contg.",68527-27-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c0800f3-4bfa-46cb-b367-09b10a1ee437/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_5e538aaf-9686-4107-a95e-1df5f89a921e.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), full-range alkylate, butane-contg.",68527-27-5," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c0800f3-4bfa-46cb-b367-09b10a1ee437/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_5e538aaf-9686-4107-a95e-1df5f89a921e.html,,,,,, "Naphtha (petroleum), full-range alkylate, butane-contg.",68527-27-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c0800f3-4bfa-46cb-b367-09b10a1ee437/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_5e538aaf-9686-4107-a95e-1df5f89a921e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), full-range alkylate, butane-contg.",68527-27-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c0800f3-4bfa-46cb-b367-09b10a1ee437/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_5e538aaf-9686-4107-a95e-1df5f89a921e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), full-range alkylate, butane-contg.",68527-27-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c0800f3-4bfa-46cb-b367-09b10a1ee437/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_5e538aaf-9686-4107-a95e-1df5f89a921e.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Hydrocarbons, C4-12, naphtha-cracking, hydrotreated",92045-61-9,"After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and in humans. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07612ee2-0cd2-4087-9c90-d37a980e14c6/documents/0a65e697-ca75-4710-87c1-abe636e0b74a_a802522d-40a1-4301-bf8b-e1898e422ebd.html,,,,,, "Hydrocarbons, C4-12, naphtha-cracking, hydrotreated",92045-61-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07612ee2-0cd2-4087-9c90-d37a980e14c6/documents/0a65e697-ca75-4710-87c1-abe636e0b74a_a802522d-40a1-4301-bf8b-e1898e422ebd.html,Chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Hydrocarbons, C4-12, naphtha-cracking, hydrotreated",92045-61-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07612ee2-0cd2-4087-9c90-d37a980e14c6/documents/0a65e697-ca75-4710-87c1-abe636e0b74a_a802522d-40a1-4301-bf8b-e1898e422ebd.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human (epidemiological findings) "Hydrocarbons, C4-12, naphtha-cracking, hydrotreated",92045-61-9," Benzene does not pose an acute hazard following ingestion (oral LD50 > 2000 mg/kg), skin contact (dermal LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07612ee2-0cd2-4087-9c90-d37a980e14c6/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_a802522d-40a1-4301-bf8b-e1898e422ebd.html,,,,,, "Hydrocarbons, C4-12, naphtha-cracking, hydrotreated",92045-61-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07612ee2-0cd2-4087-9c90-d37a980e14c6/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_a802522d-40a1-4301-bf8b-e1898e422ebd.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C4-12, naphtha-cracking, hydrotreated",92045-61-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07612ee2-0cd2-4087-9c90-d37a980e14c6/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_a802522d-40a1-4301-bf8b-e1898e422ebd.html,,dermal,LD50,"8,260 mg/kg bw",no adverse effect observed, "Hydrocarbons, C4-12, naphtha-cracking, hydrotreated",92045-61-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07612ee2-0cd2-4087-9c90-d37a980e14c6/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_a802522d-40a1-4301-bf8b-e1898e422ebd.html,,inhalation,LC50,"43,767 mg/m3",no adverse effect observed, "Gasoline, natural",8006-61-9,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b9303eb-6307-432c-98d9-7682f5c7c4d6/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_a2ae8a0d-905a-4e1a-b027-8b15c300e9be.html,,,,,, "Gasoline, natural",8006-61-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b9303eb-6307-432c-98d9-7682f5c7c4d6/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_a2ae8a0d-905a-4e1a-b027-8b15c300e9be.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Gasoline, natural",8006-61-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b9303eb-6307-432c-98d9-7682f5c7c4d6/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_a2ae8a0d-905a-4e1a-b027-8b15c300e9be.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Gasoline, natural",8006-61-9," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b9303eb-6307-432c-98d9-7682f5c7c4d6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_a2ae8a0d-905a-4e1a-b027-8b15c300e9be.html,,,,,, "Gasoline, natural",8006-61-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b9303eb-6307-432c-98d9-7682f5c7c4d6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_a2ae8a0d-905a-4e1a-b027-8b15c300e9be.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Gasoline, natural",8006-61-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b9303eb-6307-432c-98d9-7682f5c7c4d6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_a2ae8a0d-905a-4e1a-b027-8b15c300e9be.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gasoline, natural",8006-61-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b9303eb-6307-432c-98d9-7682f5c7c4d6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_a2ae8a0d-905a-4e1a-b027-8b15c300e9be.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, Benzene,71-43-2," After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and humans. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd903212-035a-4842-90e6-4c8a8d46d42d/documents/IUC5-b6f43388-16b9-400c-aab7-d69a9ff6ef49_ffff75e3-48ff-4bd2-b4df-49ea2b886327.html,,,,,, Benzene,71-43-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd903212-035a-4842-90e6-4c8a8d46d42d/documents/IUC5-b6f43388-16b9-400c-aab7-d69a9ff6ef49_ffff75e3-48ff-4bd2-b4df-49ea2b886327.html,Chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat Benzene,71-43-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd903212-035a-4842-90e6-4c8a8d46d42d/documents/IUC5-b6f43388-16b9-400c-aab7-d69a9ff6ef49_ffff75e3-48ff-4bd2-b4df-49ea2b886327.html,Chronic toxicity – systemic effects,inhalation,NOAEC,1.6 mg/m3,,other:human (epidemiological findings) Benzene,71-43-2,"Benzene does not pose an acute hazard following ingestion (oral LD50 > 2000 mg/kg), skin contact (dermal LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd903212-035a-4842-90e6-4c8a8d46d42d/documents/IUC5-f9adf04f-6301-4665-a3b1-c6f8a7a2e59f_ffff75e3-48ff-4bd2-b4df-49ea2b886327.html,,,,,, Benzene,71-43-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd903212-035a-4842-90e6-4c8a8d46d42d/documents/IUC5-f9adf04f-6301-4665-a3b1-c6f8a7a2e59f_ffff75e3-48ff-4bd2-b4df-49ea2b886327.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Benzene,71-43-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd903212-035a-4842-90e6-4c8a8d46d42d/documents/IUC5-f9adf04f-6301-4665-a3b1-c6f8a7a2e59f_ffff75e3-48ff-4bd2-b4df-49ea2b886327.html,,dermal,LD50,"8,260 mg/kg bw",no adverse effect observed, Benzene,71-43-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd903212-035a-4842-90e6-4c8a8d46d42d/documents/IUC5-f9adf04f-6301-4665-a3b1-c6f8a7a2e59f_ffff75e3-48ff-4bd2-b4df-49ea2b886327.html,,inhalation,LC50,"43,767 mg/m3",no adverse effect observed, "2,2-dimethylpropan-1-ol, tribromo derivative; 3-bromo-2,2-bis(bromomethyl)propan-1-ol",36483-57-5,14 day repeated dose Oral toxicity test NOAEL= 1000 mg/kg bw/day (females); 300 mg/kg bw/day (males)30 day feeding study with FR-1360:NOAEL= 300 mg/kg bw/day (females); 30 mg/kg bw/day (males) ,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/92da705c-69d7-4509-b7b8-7d5dfad9c38a/documents/IUC5-c6c8c837-5d35-4d92-aeeb-aaccc0411bfa_bbc15ed2-83e7-476c-898f-1690c7f71647.html,,,,,, "2,2-dimethylpropan-1-ol, tribromo derivative; 3-bromo-2,2-bis(bromomethyl)propan-1-ol",36483-57-5,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/92da705c-69d7-4509-b7b8-7d5dfad9c38a/documents/IUC5-c6c8c837-5d35-4d92-aeeb-aaccc0411bfa_bbc15ed2-83e7-476c-898f-1690c7f71647.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "2,2-dimethylpropan-1-ol, tribromo derivative; 3-bromo-2,2-bis(bromomethyl)propan-1-ol",36483-57-5,Acute Oral toxicity study to ratsAcute dermal toxicity study to rats ,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92da705c-69d7-4509-b7b8-7d5dfad9c38a/documents/IUC5-3c4b237d-58d4-4099-a584-2e2a0bfa7baf_bbc15ed2-83e7-476c-898f-1690c7f71647.html,,,,,, "2,2-dimethylpropan-1-ol, tribromo derivative; 3-bromo-2,2-bis(bromomethyl)propan-1-ol",36483-57-5,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92da705c-69d7-4509-b7b8-7d5dfad9c38a/documents/IUC5-3c4b237d-58d4-4099-a584-2e2a0bfa7baf_bbc15ed2-83e7-476c-898f-1690c7f71647.html,,oral,LD50,"2,000 mg/kg bw",, "2,2-dimethylpropan-1-ol, tribromo derivative; 3-bromo-2,2-bis(bromomethyl)propan-1-ol",36483-57-5,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92da705c-69d7-4509-b7b8-7d5dfad9c38a/documents/IUC5-3c4b237d-58d4-4099-a584-2e2a0bfa7baf_bbc15ed2-83e7-476c-898f-1690c7f71647.html,,dermal,LD50,"2,000 mg/kg bw",, "4,4'-sulphonyldiphenol",80-09-1,"In a subchronic study in Wistar rats following gavage administration of the test compound for 90 days, the NOAEL and LOAEL was 100 and 300 mg/kg bw/day, respectively (BASF SE, 2014). ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c405b30-c0bd-497a-944a-1754da992ca0/documents/IUC5-70fdbf21-5b3f-4af3-8505-cf9ae8846794_7d854382-da37-4144-a7c2-c55fe4c51973.html,,,,,, "4,4'-sulphonyldiphenol",80-09-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c405b30-c0bd-497a-944a-1754da992ca0/documents/IUC5-70fdbf21-5b3f-4af3-8505-cf9ae8846794_7d854382-da37-4144-a7c2-c55fe4c51973.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "4,4'-sulphonyldiphenol",80-09-1,"According to EU standards, no classification for oral exposure is required.Oral LD50 = 2830 mg/kg bw (male/rat)  Based on weight of evidence for acute dermal toxicity no acute dermal toxicity can be anticipated. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c405b30-c0bd-497a-944a-1754da992ca0/documents/IUC5-f94a6f1b-5d5c-41d6-9c50-2aecfdfdab29_7d854382-da37-4144-a7c2-c55fe4c51973.html,,,,,, "4,4'-sulphonyldiphenol",80-09-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c405b30-c0bd-497a-944a-1754da992ca0/documents/IUC5-f94a6f1b-5d5c-41d6-9c50-2aecfdfdab29_7d854382-da37-4144-a7c2-c55fe4c51973.html,,oral,LD50,"2,830 mg/kg bw",adverse effect observed, Barium diboron tetraoxide,13701-59-2,The key study is reliable for the determination of the subchronic endpoint. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd73ffed-250e-4fc1-9705-5e71eca598ea/documents/d5977316-e4d0-43da-aecd-d8e705ea648d_16d600c2-f045-42aa-a27e-75803d3c6f4d.html,,,,,, Barium diboron tetraoxide,13701-59-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd73ffed-250e-4fc1-9705-5e71eca598ea/documents/d5977316-e4d0-43da-aecd-d8e705ea648d_16d600c2-f045-42aa-a27e-75803d3c6f4d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,70 mg/kg bw/day,,rat Barium diboron tetraoxide,13701-59-2, The study is sufficient for the purposes of hazard classification. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd73ffed-250e-4fc1-9705-5e71eca598ea/documents/e75de17a-fcab-4817-9712-59fe499aabca_16d600c2-f045-42aa-a27e-75803d3c6f4d.html,,,,,, Barium diboron tetraoxide,13701-59-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd73ffed-250e-4fc1-9705-5e71eca598ea/documents/e75de17a-fcab-4817-9712-59fe499aabca_16d600c2-f045-42aa-a27e-75803d3c6f4d.html,,oral,LD50,530 mg/kg bw,adverse effect observed, Barium diboron tetraoxide,13701-59-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd73ffed-250e-4fc1-9705-5e71eca598ea/documents/e75de17a-fcab-4817-9712-59fe499aabca_16d600c2-f045-42aa-a27e-75803d3c6f4d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Barium diboron tetraoxide,13701-59-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd73ffed-250e-4fc1-9705-5e71eca598ea/documents/e75de17a-fcab-4817-9712-59fe499aabca_16d600c2-f045-42aa-a27e-75803d3c6f4d.html,,inhalation,LC50,"3,540 mg/m3",no adverse effect observed, "2,4,6-tri-tert-butylphenol",732-26-3,ORALA combined repeated dose toxicity study with the reproduction/developmental toxicity screening test is available in which the NOAEL of the substance was determined to be 3 mg/kg in male and female rats.Furthermore a 2 year chronic study is available in which the NOAEL of the substance was determined to be 1.5 mg/kg in male and female rats. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc940735-75c9-4bc1-9785-4c2d19aa6cbb/documents/IUC5-b6621f67-69a3-4fdc-8e4c-fc5075dde13e_768b1197-8b7c-4644-b172-aaa85a13ce96.html,,,,,, "2,4,6-tri-tert-butylphenol",732-26-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc940735-75c9-4bc1-9785-4c2d19aa6cbb/documents/IUC5-b6621f67-69a3-4fdc-8e4c-fc5075dde13e_768b1197-8b7c-4644-b172-aaa85a13ce96.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,1.5 mg/kg bw/day,,rat "2,4,6-tri-tert-butylphenol",732-26-3,ORALA single acute toxicity study is currently available in which the acute oral LD50 of the substance was determined to be >200 mg/kg in the rat.DERMALA single acute toxicity study is currently available in which the acute dermal LD50 of the substance was determined to exceed 2000 mg/kg in the rat. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc940735-75c9-4bc1-9785-4c2d19aa6cbb/documents/IUC5-e88b85b0-15e8-459c-be61-9c814b1b79b9_768b1197-8b7c-4644-b172-aaa85a13ce96.html,,,,,, "2,4,6-tri-tert-butylphenol",732-26-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc940735-75c9-4bc1-9785-4c2d19aa6cbb/documents/IUC5-e88b85b0-15e8-459c-be61-9c814b1b79b9_768b1197-8b7c-4644-b172-aaa85a13ce96.html,,oral,LD50,200 mg/kg bw,adverse effect observed, "2,4,6-tri-tert-butylphenol",732-26-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc940735-75c9-4bc1-9785-4c2d19aa6cbb/documents/IUC5-e88b85b0-15e8-459c-be61-9c814b1b79b9_768b1197-8b7c-4644-b172-aaa85a13ce96.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dibutyltin di(acetate),1067-33-0,"The following studies have been submitted to address the repeated dose toxicity: oral endpoint:Waalkens-Berendsen DH (2003) Dibutyldichlorostannane (CAS # 683-18-1): Reproduction/developmental toxicity screening test in rats, TNO, Project Organisation, Ecotoxicology, Utrechtseweg 48, P.O. Box 370, 3700 AJ Zeist, The Netherlands, Report No.: V 4906, Organotin Environmental Programme (ORTEP) Association, Stabilizer Task Force. Report Date.: 2003-12-04. studBarnes, J. M. and Stoner, H. B. (1958). Toxic properties of some dialkyl and trialkyl tin salts. Brit. J. Industr. Med., 1958, 15, 15.Gaunt et al (1968). Acute and Short-term Toxicity Studies on Di-n-butyltin Dichloride in Rats. Fd Cosmet. Toxicol. Vol. 6, pp. 599-608.Penninks A. H. & Seinen W. (1982). COMPARATIVE TOXICITY OF ALKYLTIN AND ESTERTIN STABILIZERS. Fd Chem. Toxic. Vol. 20. pp. 909 to 916.The Gaunt et al (1968) study has been allocated a Klimisch core of 2 on the basis that the study predates GLP; however, method was comparable to OECD Guideline 408. The effect of DBT exposure on the thymus of was not assessed in this study. No information on the stability or homogeneity of the test material in the DBTC-prepared diets. The study was performed with dibutyltin dichloride.The Penninks and Seinen (1982) study has also been allocated a Klimisch score of 2 on the basis that the study is a short-term feeding study with no information on the stability of the test substance in the diet or homogeneity of the test diets provided. The purity of the test substance (dibutyltin dichloride) is not reported. The Barnes and Stoner (1958) study has been allocated a Klimisch score of 4.Dibutyltin chloride was the test substance employed in all the studies presented under repeated dose toxicity. Under gastric conditions, the substance in question is anticipated to hydrolyse to dibutyltin chloride. A read-across approach from dibutyltin chloride was considered acceptable when dosing repeatedly via the oral route. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dfaa30a9-429e-4536-897f-a5839a41ac44/documents/IUC5-8f55b883-f83c-4b04-b35e-fa2943d2fbf1_cf298359-f70a-453a-b357-5977288038e2.html,,,,,, Dibutyltin di(acetate),1067-33-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dfaa30a9-429e-4536-897f-a5839a41ac44/documents/IUC5-8f55b883-f83c-4b04-b35e-fa2943d2fbf1_cf298359-f70a-453a-b357-5977288038e2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.3 mg/kg bw/day,,rat Dibutyltin di(acetate),1067-33-0,"In accordance with column 2 of REACH annex VIII, it is considered justifiable to omit the acute toxicity studies as the substance is classified as corrosive to the skin.The following supporting studies were available for the acute toxicity: oral endpoint:Schafer E. W. & Bowles A. W. (1985). Acute Oral Toxicity and Repellency of 933 Chemicals to House and Deer Mice. Arch. Environ. Contam. Toxicol. 14: 111-129. Testing laboratory: U. S. Department of Interior - Fish and Wildlife Service, Denver Wildlife Research Center, Building 16 - Denver Federal Center, Denver, Colorado 80225.Result: An approximate lethal dose of dibutyltin diacetate in deer mice was determined to be 1070 mg/kg. A second toxicity test determined the LD50 of dibutyltin diacetate of >87.5 mg/kg/day.Acros Organics (2007). Material Safety Data Sheet. Dibutyltin diacetate pract. website https: //fscimage. fishersci. com/msds/75959. htm. Owner company: Acros Organics N. V., One Reagent Lane, Fair Lawn, NJ 07410. Study number: ACC# 75959. Report date: 2007-03-16.Result: This MSDS reported an LD50 of 46mg/kg for dibutyltin diacetate for mouse and an LD50 of 32mg/kg for rat. According to the MSDS, dibutyltin diacetate is classified as 'Toxic if Swallowed'. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfaa30a9-429e-4536-897f-a5839a41ac44/documents/IUC5-b6293f74-f67f-4143-95e1-3f3346812997_cf298359-f70a-453a-b357-5977288038e2.html,,,,,, Tellurium dioxide,7446-07-3, The main effect observed upon oral exposure in the different sub-acute and sub-chronic available studies is reduction of weight and weight gain. At microscopic examination also changes in the liver were noted. However the severeness of the effects vary within the different studies and affected animals recover upon cessation of the treatment. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/71c9ea88-6c9f-4708-9ff9-e6f161cf4aed/documents/IUC5-b9732e6a-ac85-46e9-8897-54f2e1985819_1b3ca8db-d207-44b0-b45a-c6ef90160512.html,,,,,, Tellurium dioxide,7446-07-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/71c9ea88-6c9f-4708-9ff9-e6f161cf4aed/documents/IUC5-b9732e6a-ac85-46e9-8897-54f2e1985819_1b3ca8db-d207-44b0-b45a-c6ef90160512.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Tellurium dioxide,7446-07-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71c9ea88-6c9f-4708-9ff9-e6f161cf4aed/documents/IUC5-d71b5ecd-727e-493d-8ad3-9c3eefd1175a_1b3ca8db-d207-44b0-b45a-c6ef90160512.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Reaction mass of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide and of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide; isopyrazam",881685-58-1,"- Oral: NOAEL = 5.5 and 6.9 mg/kg bw/day in males and females, respectively, rats, chronic toxicity, 2 years, dietary, according to OECD TG 453, Milburn 2008 ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d65b900f-8c73-40e6-8042-bdb09e04d85d/documents/ebc06a16-dd98-4dcd-a704-6f2ee88d5b30_7a15cb5c-72ef-4e11-83fd-2e6a880c21d2.html,,,,,, "Reaction mass of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide and of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide; isopyrazam",881685-58-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d65b900f-8c73-40e6-8042-bdb09e04d85d/documents/ebc06a16-dd98-4dcd-a704-6f2ee88d5b30_7a15cb5c-72ef-4e11-83fd-2e6a880c21d2.html,Chronic toxicity – systemic effects,oral,NOAEL,5.5 mg/kg bw/day,,rat "Reaction mass of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide and of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide; isopyrazam",881685-58-1,"- Oral: LD50 > 2000 mg/kg bw, females, rat, according to OECD TG 425, Matting 2014 - Inhalation: LC50 > 2.6 mg/L, males/females, rat, according to OECD TG 403, Nagy 2014 - Dermal: LD50 > 2000 mg/kg bw, males/females, rat, according to OECD TG 402, Matting 2014 ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d65b900f-8c73-40e6-8042-bdb09e04d85d/documents/2d93b956-cdbb-4329-9750-0a81b8963fac_7a15cb5c-72ef-4e11-83fd-2e6a880c21d2.html,,,,,, "Reaction mass of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide and of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide; isopyrazam",881685-58-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d65b900f-8c73-40e6-8042-bdb09e04d85d/documents/2d93b956-cdbb-4329-9750-0a81b8963fac_7a15cb5c-72ef-4e11-83fd-2e6a880c21d2.html,,oral,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, "Reaction mass of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide and of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide; isopyrazam",881685-58-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d65b900f-8c73-40e6-8042-bdb09e04d85d/documents/2d93b956-cdbb-4329-9750-0a81b8963fac_7a15cb5c-72ef-4e11-83fd-2e6a880c21d2.html,,dermal,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, "Reaction mass of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9RS)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide and of 3-(difluoromethyl)-1-methyl-N-[(1RS,4SR,9SR)-1,2,3,4-tetrahydro-9-isopropyl-1,4-methanonaphthalen-5-yl]pyrazole-4-carboxamide; isopyrazam",881685-58-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d65b900f-8c73-40e6-8042-bdb09e04d85d/documents/2d93b956-cdbb-4329-9750-0a81b8963fac_7a15cb5c-72ef-4e11-83fd-2e6a880c21d2.html,,inhalation,discriminating conc.,> 2.6 mg/L,no adverse effect observed, "6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid",2156592-54-8,"The registration substance induced liver effect, possibly via metabolic overload. The NOAEL of 40 mg/kg bw/day was obtained in the 28-day toxicity study for the registration substance and also in the combined repeated dose and reproductive/developmental toxicity screening test for the read-across supporting substance. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24974a58-0d04-40d7-b5a5-e0ba7e6d0c0f/documents/IUC5-079d8a2e-5177-477f-aaba-967ddf5ff0df_e20d912d-b4a7-4113-9fcf-88e60c02428c.html,,,,,, "6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid",2156592-54-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24974a58-0d04-40d7-b5a5-e0ba7e6d0c0f/documents/IUC5-079d8a2e-5177-477f-aaba-967ddf5ff0df_e20d912d-b4a7-4113-9fcf-88e60c02428c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat "6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid",2156592-54-8,"For oral or dermal route, the acute toxicity of the registration substance is assessed as of no concern. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24974a58-0d04-40d7-b5a5-e0ba7e6d0c0f/documents/IUC5-d9cc698d-7629-4bfe-90dd-be6888cb76ae_e20d912d-b4a7-4113-9fcf-88e60c02428c.html,,,,,, "6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid",2156592-54-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24974a58-0d04-40d7-b5a5-e0ba7e6d0c0f/documents/IUC5-d9cc698d-7629-4bfe-90dd-be6888cb76ae_e20d912d-b4a7-4113-9fcf-88e60c02428c.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "6-[(C10-C13)-alkyl-(branched, unsaturated)-2,5-dioxopyrrolidin-1-yl]hexanoic acid",2156592-54-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24974a58-0d04-40d7-b5a5-e0ba7e6d0c0f/documents/IUC5-d9cc698d-7629-4bfe-90dd-be6888cb76ae_e20d912d-b4a7-4113-9fcf-88e60c02428c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Cumene,98-82-8,"Reliable studies are available for inhalation, which revealed a NOAEC 612 mg/m3 (= 125 ppm). In addition other subchronic inhalation studies revealed an NOAEC of 100 ppm (= 490 mg/m3). In oral subchronic studies a NOAEL of 154 mg/kg bw/d have been obtained. However, the documentation of this study is limited. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/464855e9-e8cc-4dbe-a346-69d43f5c21dc/documents/IUC5-6aa48758-d3f9-47fd-9073-2e579c31a1ed_8fc91a5a-7ab6-41a7-9284-8a5189413ce7.html,,,,,, Cumene,98-82-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/464855e9-e8cc-4dbe-a346-69d43f5c21dc/documents/IUC5-6aa48758-d3f9-47fd-9073-2e579c31a1ed_8fc91a5a-7ab6-41a7-9284-8a5189413ce7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,154 mg/kg bw/day,, Cumene,98-82-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/464855e9-e8cc-4dbe-a346-69d43f5c21dc/documents/IUC5-6aa48758-d3f9-47fd-9073-2e579c31a1ed_8fc91a5a-7ab6-41a7-9284-8a5189413ce7.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,612 mg/m3,, Cumene,98-82-8,For acute oral toxicity an LD50 of 2260 mg/kg bw is available. Data on inhalation toxicity revealed an LC50 >17.6 mg/L (=g/m3). And for dermal toxicity an LD50 >3160 mg/L was derived. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/464855e9-e8cc-4dbe-a346-69d43f5c21dc/documents/IUC5-92aa58f7-f4e3-4daa-b620-7141bd14c0c0_8fc91a5a-7ab6-41a7-9284-8a5189413ce7.html,,,,,, Cumene,98-82-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/464855e9-e8cc-4dbe-a346-69d43f5c21dc/documents/IUC5-92aa58f7-f4e3-4daa-b620-7141bd14c0c0_8fc91a5a-7ab6-41a7-9284-8a5189413ce7.html,,oral,LD50,"2,260 mg/kg bw",, N-(2-nitrophenyl)phosphoric triamide,874819-71-3, 28-day oral repeated dose toxicity study according to OECD guideline 407: NOAEL 30 mg/kg b.w. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44cf518e-c100-46e9-9b4a-17ba8174b3f2/documents/IUC5-2ad7ff81-cfd5-4ab8-93da-8e502d792fa1_6a5d0779-cd88-4a3e-b3c5-dbb96a84c9ce.html,,,,,, N-(2-nitrophenyl)phosphoric triamide,874819-71-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44cf518e-c100-46e9-9b4a-17ba8174b3f2/documents/IUC5-2ad7ff81-cfd5-4ab8-93da-8e502d792fa1_6a5d0779-cd88-4a3e-b3c5-dbb96a84c9ce.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat N-(2-nitrophenyl)phosphoric triamide,874819-71-3,Acute oral toxicity:LD50 > 2000 mg/kg bw. Acute dermal toxicity:LD50 > 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44cf518e-c100-46e9-9b4a-17ba8174b3f2/documents/IUC5-eb344128-37e6-4f9b-8e08-1706085d9da7_6a5d0779-cd88-4a3e-b3c5-dbb96a84c9ce.html,,,,,, N-(2-nitrophenyl)phosphoric triamide,874819-71-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44cf518e-c100-46e9-9b4a-17ba8174b3f2/documents/IUC5-eb344128-37e6-4f9b-8e08-1706085d9da7_6a5d0779-cd88-4a3e-b3c5-dbb96a84c9ce.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, N-(2-nitrophenyl)phosphoric triamide,874819-71-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44cf518e-c100-46e9-9b4a-17ba8174b3f2/documents/IUC5-eb344128-37e6-4f9b-8e08-1706085d9da7_6a5d0779-cd88-4a3e-b3c5-dbb96a84c9ce.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "pentapotassium 2,2',2"",2""',2""""-(ethane-1,2-diylnitrilo)pentaacetate",7216-95-7,"One 28-day oral gavage study in rats using pentapotassium DTPA and one 28-day oral drinking water study using pentasodium DTPA, one 90-day and one 5-day inhalation study using disodium EDTA. Additional information comes from published literature on the salts of DTPA such as zinc and calcium. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5223b9a6-528c-440e-9f31-db1df423b4c2/documents/IUC5-f5c5a610-e163-4665-bdf4-e108a528df0a_eef8e4cf-fad0-4de6-a62c-b105cc042ab5.html,,,,,, "pentapotassium 2,2',2"",2""',2""""-(ethane-1,2-diylnitrilo)pentaacetate",7216-95-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5223b9a6-528c-440e-9f31-db1df423b4c2/documents/IUC5-f5c5a610-e163-4665-bdf4-e108a528df0a_eef8e4cf-fad0-4de6-a62c-b105cc042ab5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,83 mg/kg bw/day,,rat "pentapotassium 2,2',2"",2""',2""""-(ethane-1,2-diylnitrilo)pentaacetate",7216-95-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5223b9a6-528c-440e-9f31-db1df423b4c2/documents/IUC5-f5c5a610-e163-4665-bdf4-e108a528df0a_eef8e4cf-fad0-4de6-a62c-b105cc042ab5.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,15 mg/m3,,rat "pentapotassium 2,2',2"",2""',2""""-(ethane-1,2-diylnitrilo)pentaacetate",7216-95-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5223b9a6-528c-440e-9f31-db1df423b4c2/documents/IUC5-f5c5a610-e163-4665-bdf4-e108a528df0a_eef8e4cf-fad0-4de6-a62c-b105cc042ab5.html,Repeated dose toxicity – local effects,inhalation,NOAEC,3 mg/m3,adverse effect observed,rat "pentapotassium 2,2',2"",2""',2""""-(ethane-1,2-diylnitrilo)pentaacetate",7216-95-7,"Oral: 1 acute oral study using DTPA acid; 4 acute oral studies using pentasodium DTP'; 2 acute oral studies using pentapotassium DTPA.Dermal: 1 acute dermal study using pentapotassium DTPAInhalation: 1 acute inhalation study using pentasodium DTPA vapour, 1 using a structurally related compound disodium EDTA ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5223b9a6-528c-440e-9f31-db1df423b4c2/documents/IUC5-8be67f11-9548-4cc8-a3f1-c8485024dd1a_eef8e4cf-fad0-4de6-a62c-b105cc042ab5.html,,,,,, (E)-2-methoxy-4-(prop-1-enyl)phenol,5932-68-3,"Repeated dose toxicity oral: systemic NOAEL = 150 mg/kg bw/day in female mice (similar to OECD 408, K, rel. 2) Repeated dose toxicity oral: local NOAEL = 75 mg/kg bw/day in mice (similar to OECD 408, K, rel. 2)Repeated dose toxicity inhalation: local LOAEC = 1 mg/m3 in rats (OECD 412, GLP, K, rel.1) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/27d44c86-96ef-4234-8afe-3883cc5bb346/documents/baa98401-938e-48bb-b96f-ba8845e0b939_e735d98d-2ef2-4bdb-ade9-a8f9acb1acf5.html,,,,,, (E)-2-methoxy-4-(prop-1-enyl)phenol,5932-68-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/27d44c86-96ef-4234-8afe-3883cc5bb346/documents/baa98401-938e-48bb-b96f-ba8845e0b939_e735d98d-2ef2-4bdb-ade9-a8f9acb1acf5.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,1 mg/m3,,rat (E)-2-methoxy-4-(prop-1-enyl)phenol,5932-68-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/27d44c86-96ef-4234-8afe-3883cc5bb346/documents/baa98401-938e-48bb-b96f-ba8845e0b939_e735d98d-2ef2-4bdb-ade9-a8f9acb1acf5.html,Chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat (E)-2-methoxy-4-(prop-1-enyl)phenol,5932-68-3,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/27d44c86-96ef-4234-8afe-3883cc5bb346/documents/baa98401-938e-48bb-b96f-ba8845e0b939_e735d98d-2ef2-4bdb-ade9-a8f9acb1acf5.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1 mg/m3,adverse effect observed,rat (E)-2-methoxy-4-(prop-1-enyl)phenol,5932-68-3,"Acute toxicity: lowest oral: LD50 = 541.5 mg/kg bw (RA to Isoeugenol, not OECD not GLP, WoE, rel. 4) in mice;Acute toxicity: dermal: LD50 = 1911.6 mg/kg bw (Similar to OECD 402, K, rel. 2) in rabbits;Acute toxicity: inhalation: worst-case classification as Harmful if inhaled. No study was identified on the registered substance (trans-Isoeugenol). However, two studies were available on the supporting substance (Isoeugenol, mixture of cis- and trans-Isoeugenol). Several species were tested. The two studies were not sufficiently reliable as such (Klimisch = 4) but were considered sufficiently reliable in a weight of evidence for the purpose of hazard assessment. The study having the lowest LD50 was taken as the key value for this endpoint. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): No standard acute inhalation toxicity study was available on the registered substance. However, relevant data from other inhalation studies were used to conclude on the acute hazard via inhalation. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The key study performed in rats was pre-GLP, but was similar to OECD Test Guideline No 402. This study was considered sufficiently robust to cover this endpoint. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27d44c86-96ef-4234-8afe-3883cc5bb346/documents/f4198f50-8980-4370-85cd-d2766ae243cf_e735d98d-2ef2-4bdb-ade9-a8f9acb1acf5.html,,,,,, (E)-2-methoxy-4-(prop-1-enyl)phenol,5932-68-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27d44c86-96ef-4234-8afe-3883cc5bb346/documents/f4198f50-8980-4370-85cd-d2766ae243cf_e735d98d-2ef2-4bdb-ade9-a8f9acb1acf5.html,,oral,LD50,541.5 mg/kg bw,adverse effect observed, (E)-2-methoxy-4-(prop-1-enyl)phenol,5932-68-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27d44c86-96ef-4234-8afe-3883cc5bb346/documents/f4198f50-8980-4370-85cd-d2766ae243cf_e735d98d-2ef2-4bdb-ade9-a8f9acb1acf5.html,,dermal,LD50,"1,911 mg/kg bw",adverse effect observed, "(R)-p-mentha-1,8-diene",5989-27-5," When administered orally by gavage for at least 6 months, d-limonene induces some toxicological effects from 1000 mg/kg bw/d. At this dose level, following 90 day of exposure, d-limonene induces decreased bodyweight gain and clinical signs in mice. 180 days of exposure to d-limonene at this dose level decreased bodyweight gain and increased relative and absolute kidney weights (with protein casts in the renal tubules of females). The most relevant LOAEL value to derive the DNEL is considered to be 1000 mg/kg bw from the 180-d dog study, which was the lowest dose tested with no effect. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/490ebcb8-215c-4c1e-964d-0180cddf7e2c/documents/2c08fe33-09d1-4201-a812-d70828c21fcd_762a5488-9153-4170-a6ec-32966cbf0d5b.html,,,,,, "(R)-p-mentha-1,8-diene",5989-27-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/490ebcb8-215c-4c1e-964d-0180cddf7e2c/documents/2c08fe33-09d1-4201-a812-d70828c21fcd_762a5488-9153-4170-a6ec-32966cbf0d5b.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,"1,000 mg/kg bw/day",,dog "(R)-p-mentha-1,8-diene",5989-27-5,All studies available show oral LD50 at least equal to or higher than 2000 mg/kg bw in rats.All studies available show dermal LD50 equal to or higher than 5000 mg/kg bw in rabbits. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/490ebcb8-215c-4c1e-964d-0180cddf7e2c/documents/41ac9f64-5047-4d4f-b481-1e6899f38de0_762a5488-9153-4170-a6ec-32966cbf0d5b.html,,,,,, "(R)-p-mentha-1,8-diene",5989-27-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/490ebcb8-215c-4c1e-964d-0180cddf7e2c/documents/41ac9f64-5047-4d4f-b481-1e6899f38de0_762a5488-9153-4170-a6ec-32966cbf0d5b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(R)-p-mentha-1,8-diene",5989-27-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/490ebcb8-215c-4c1e-964d-0180cddf7e2c/documents/41ac9f64-5047-4d4f-b481-1e6899f38de0_762a5488-9153-4170-a6ec-32966cbf0d5b.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "(S)-p-mentha-1,8-diene",5989-54-8," There was no data on l-limonene repeated dose toxicity. Therefore, the read-across from the analogue substance d-limonene is applied. When administered orally by gavage for at least 6 months, d-limonene induces some toxicological effects from 1000 mg/kg bw/d. At this dose level, following 90 days of exposure, d-limonene induces decreased bodyweight gain and clinical signs in mice. 180 days of exposure to d-limonene at this dose level decreased bodyweight gain and increased relative and absolute kidney weights of dogs (with protein casts in the renal tubules of females). The most relevant LOAEL value to derive the DNEL is considered to be 1000 mg/kg bw from the 180-d dog study. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/463ce750-8d68-4b45-88dd-a49a6e745fbc/documents/IUC5-62afcf0e-1cc5-4daf-9fbc-d3e4c6f6faf2_eba9c158-72cb-48d3-9ab9-a6dcf7173f97.html,,,,,, "(S)-p-mentha-1,8-diene",5989-54-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/463ce750-8d68-4b45-88dd-a49a6e745fbc/documents/IUC5-62afcf0e-1cc5-4daf-9fbc-d3e4c6f6faf2_eba9c158-72cb-48d3-9ab9-a6dcf7173f97.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,"1,000 mg/kg bw/day",,dog "(S)-p-mentha-1,8-diene",5989-54-8," Acute toxicity, oral route: Weight of evidence: All studies available show  oral LD50 at least equal to or higher than 2000 mg/kg bw in rats. Acute toxicity, dermal route: Weight of evidence: All studies available show dermal LD50 equal to or higher than 5000 mg/kg bw in rabbits. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/463ce750-8d68-4b45-88dd-a49a6e745fbc/documents/IUC5-10cee1fa-6763-440a-a0e4-fe94563f174c_eba9c158-72cb-48d3-9ab9-a6dcf7173f97.html,,,,,, "(S)-p-mentha-1,8-diene",5989-54-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/463ce750-8d68-4b45-88dd-a49a6e745fbc/documents/IUC5-10cee1fa-6763-440a-a0e4-fe94563f174c_eba9c158-72cb-48d3-9ab9-a6dcf7173f97.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(S)-p-mentha-1,8-diene",5989-54-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/463ce750-8d68-4b45-88dd-a49a6e745fbc/documents/IUC5-10cee1fa-6763-440a-a0e4-fe94563f174c_eba9c158-72cb-48d3-9ab9-a6dcf7173f97.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, (+)-menthol,15356-60-2,"This endpoint is not required for the REACh registration purpose of D-Menthol. Nevertheless, we decided to use the chronic datas available on a mix of menthol isomers and on L-Menthol to derive some DNELs for Human health hazard assessment.Data Summary:No existence of intrinsic repeated dose study on L and DL-menthol.No effect observed up to 7500ppm ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05aa72bf-0b25-4232-a0d6-a5333a267bab/documents/IUC5-076a3803-ee2a-460a-afeb-f1236654dfd3_0cfe3306-d002-4703-b722-da6fb1a33559.html,,,,,, (+)-menthol,15356-60-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05aa72bf-0b25-4232-a0d6-a5333a267bab/documents/IUC5-076a3803-ee2a-460a-afeb-f1236654dfd3_0cfe3306-d002-4703-b722-da6fb1a33559.html,Chronic toxicity – systemic effects,oral,NOAEL,375 mg/kg bw/day,,rat (+)-menthol,15356-60-2,Low acute toxicity for oral route ( 2000 mg/kg bw).Low acute toxicity dermal (5000 mg/kg bw) extrapolated to D-MentholIt can be expected the same low acute toxicity for the inhalation route. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05aa72bf-0b25-4232-a0d6-a5333a267bab/documents/IUC5-6e6e638c-7415-4b91-8b1b-c5ba2543fbe5_0cfe3306-d002-4703-b722-da6fb1a33559.html,,,,,, (+)-menthol,15356-60-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05aa72bf-0b25-4232-a0d6-a5333a267bab/documents/IUC5-6e6e638c-7415-4b91-8b1b-c5ba2543fbe5_0cfe3306-d002-4703-b722-da6fb1a33559.html,,oral,LD50,"2,000 mg/kg bw",, (+)-menthol,15356-60-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05aa72bf-0b25-4232-a0d6-a5333a267bab/documents/IUC5-6e6e638c-7415-4b91-8b1b-c5ba2543fbe5_0cfe3306-d002-4703-b722-da6fb1a33559.html,,dermal,LD50,"5,000 mg/kg bw",, "(E)-1-(2,6,6-trimethyl-2-cyclohexen-1-yl)-2-buten-1-one",24720-09-0," Read-across: 90-day oral repeated dose toxicity study : NOAEL = 30 mg/kg bw/day; LOAEL = 500 mg/kg bw/day (OECD 408, GLP, rel. 1) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/23ff4ac8-3a11-4a81-95b5-302710fa5350/documents/IUC5-da33f791-e503-4fce-a344-45b5f580971f_60ce3b59-5c16-4721-894d-116cd9b693a7.html,,,,,, "(E)-1-(2,6,6-trimethyl-2-cyclohexen-1-yl)-2-buten-1-one",24720-09-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/23ff4ac8-3a11-4a81-95b5-302710fa5350/documents/IUC5-da33f791-e503-4fce-a344-45b5f580971f_60ce3b59-5c16-4721-894d-116cd9b693a7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "(E)-1-(2,6,6-trimethyl-2-cyclohexen-1-yl)-2-buten-1-one",24720-09-0," Acute toxicity: oral: LD50 Combined = 1670 mg/kg bw  (similar to OECD 401, rats, K, rel.2); Acute toxicity: dermal: LD50 Combined = 2900 mg/kg bw (similar to OECD 402, rats, K, rel. 2); Acute toxicity: inhalation: waiver. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23ff4ac8-3a11-4a81-95b5-302710fa5350/documents/IUC5-a6a70144-e876-4595-8865-94a3fb893ca3_60ce3b59-5c16-4721-894d-116cd9b693a7.html,,,,,, "(E)-1-(2,6,6-trimethyl-2-cyclohexen-1-yl)-2-buten-1-one",24720-09-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23ff4ac8-3a11-4a81-95b5-302710fa5350/documents/IUC5-a6a70144-e876-4595-8865-94a3fb893ca3_60ce3b59-5c16-4721-894d-116cd9b693a7.html,,oral,LD50,"1,670 mg/kg bw",adverse effect observed, "(E)-1-(2,6,6-trimethyl-2-cyclohexen-1-yl)-2-buten-1-one",24720-09-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23ff4ac8-3a11-4a81-95b5-302710fa5350/documents/IUC5-a6a70144-e876-4595-8865-94a3fb893ca3_60ce3b59-5c16-4721-894d-116cd9b693a7.html,,dermal,LD50,"2,900 mg/kg bw",adverse effect observed, 2-hydroxybenzimidazole,615-16-7,"KEY STUDY, OECD 401 (KEY_401_1986_HOECHST_86.0391): LD50 female rat = 1930 mg/kg bw (= most sensitive sex)NON-KEY STUDY, unspecified guideline (NONKEY-401-2007-MSDS SYNTHESIA): LD50 rat = 1105 mg/kg bw ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c9cd944-8088-4da9-9ab1-bd5c6debe933/documents/IUC5-f7f53994-d12d-4817-b28b-73d0c8330ec6_fdb41da9-22f0-4488-9af7-6ce20a9bd053.html,,,,,, 2-hydroxybenzimidazole,615-16-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c9cd944-8088-4da9-9ab1-bd5c6debe933/documents/IUC5-f7f53994-d12d-4817-b28b-73d0c8330ec6_fdb41da9-22f0-4488-9af7-6ce20a9bd053.html,,oral,LD50,"1,930 mg/kg bw",, "Hydrocarbons, C17-30, hydrotreated distillates, distn. lights",97862-82-3,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEL (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils. A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study that tested distillate aromatic extracts. Sufficiently refined other lubricant baseoils are not classified according to DSD for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/092a889e-7aac-42a6-b000-6b98d02ea6b0/documents/IUC5-748bb69d-ce48-462f-89ca-bdf2ce955fad_e31a42b7-1eec-4e72-83a0-b42232e8525e.html,,,,,, "Hydrocarbons, C17-30, hydrotreated distillates, distn. lights",97862-82-3,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. The acute inhalation LC50 for other lubricant base oils is >5.0 mg/L. ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/092a889e-7aac-42a6-b000-6b98d02ea6b0/documents/IUC5-69a65843-7186-4761-8d35-387911c0bc26_e31a42b7-1eec-4e72-83a0-b42232e8525e.html,,,,,, "Paraffin oils (petroleum), catalytic dewaxed light",64742-71-8,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93c38006-4ece-4905-882c-ec0b81f50d6c/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_0656a8cf-2169-4d09-993a-4c2a34d46325.html,,,,,, "Paraffin oils (petroleum), catalytic dewaxed light",64742-71-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93c38006-4ece-4905-882c-ec0b81f50d6c/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_0656a8cf-2169-4d09-993a-4c2a34d46325.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Paraffin oils (petroleum), catalytic dewaxed light",64742-71-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93c38006-4ece-4905-882c-ec0b81f50d6c/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_0656a8cf-2169-4d09-993a-4c2a34d46325.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Paraffin oils (petroleum), catalytic dewaxed light",64742-71-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93c38006-4ece-4905-882c-ec0b81f50d6c/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_0656a8cf-2169-4d09-993a-4c2a34d46325.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Paraffin oils (petroleum), catalytic dewaxed light",64742-71-8,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93c38006-4ece-4905-882c-ec0b81f50d6c/documents/73761dae-46d6-428e-8e40-e5cc70088d96_0656a8cf-2169-4d09-993a-4c2a34d46325.html,,,,,, "Paraffin oils (petroleum), catalytic dewaxed light",64742-71-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93c38006-4ece-4905-882c-ec0b81f50d6c/documents/73761dae-46d6-428e-8e40-e5cc70088d96_0656a8cf-2169-4d09-993a-4c2a34d46325.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Paraffin oils (petroleum), catalytic dewaxed light",64742-71-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93c38006-4ece-4905-882c-ec0b81f50d6c/documents/73761dae-46d6-428e-8e40-e5cc70088d96_0656a8cf-2169-4d09-993a-4c2a34d46325.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Paraffin oils (petroleum), catalytic dewaxed light",64742-71-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93c38006-4ece-4905-882c-ec0b81f50d6c/documents/73761dae-46d6-428e-8e40-e5cc70088d96_0656a8cf-2169-4d09-993a-4c2a34d46325.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Distillates (petroleum), light thermal cracked",64741-82-8,"No repeat dose toxicity studies have been identified for cracked gas oils, following inhalation or oral exposure. The sub-chronic inhalation study of diesel fuel (OECD 413, a read-across study from VGO/HGO/Distillate Fuels) resulted in a conservative sub-chronic NOAEC of 0.88 mg/L determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of ≥1.71 mg/L was established for systemic effects, based on no significant findings at this level.In a 28-day sub-acute study (OECD 410), dermal exposure to a light catalytically cracked distillate resulted in limited systemic changes and a NOAEL of 500 mg/kg body weight/day.  In a 90-day sub-chronic study (OECD 411), dermal exposure to light catalytically cracked distillate resulted in a systemic NOAEL of 25 mg/kg body weight/day for males, and 125 mg/kg body weight/day for females, based upon reductions in thymus weight.  In another 90-day sub-chronic study (OECD 411), dermal exposure to coker light gas oil resulted in a systemic LOAEL of 30 mg/kg body weight/day for males and females, based upon clinical signs and irritation noted at all doses. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66b5cfcb-4a97-4131-8cba-96e1be6a35b1/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_485c0349-a31b-4edc-87e8-d5f9d037296b.html,,,,,, "Distillates (petroleum), light thermal cracked",64741-82-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66b5cfcb-4a97-4131-8cba-96e1be6a35b1/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_485c0349-a31b-4edc-87e8-d5f9d037296b.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), light thermal cracked",64741-82-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66b5cfcb-4a97-4131-8cba-96e1be6a35b1/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_485c0349-a31b-4edc-87e8-d5f9d037296b.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Distillates (petroleum), light thermal cracked",64741-82-8,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66b5cfcb-4a97-4131-8cba-96e1be6a35b1/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_485c0349-a31b-4edc-87e8-d5f9d037296b.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Distillates (petroleum), light thermal cracked",64741-82-8,"Acute Oral Toxicity:Acute oral toxicity of cracked gas oils was evaluated in male and female rats by a single oral gavage administration of a dose ranging from 2050 to 6250 mg/kg body weight.  Based on mortality and toxicity findings, an oral LD50 of 4660 mg/kg body weight and 3200 mg/kg body weight were reported for males and females, respectively.  Acute Inhalation Toxicity:Acute inhalation toxicity of cracked gas oils in rats was evaluated via whole-body exposure to test material at various measured concentrations for 4 hours.  The acute inhalation LC50 was 4.65 mg/L in males and females. Acute Dermal Toxicity:Acute dermal toxicity of cracked gas oils was evaluated in male and female rabbits at a single dose of 2000 mg/kg body weight.  Based on a lack of adverse systemic effects or mortality, the acute dermal LD50 for light catalytically cracked distillate was >2000 mg/kg body weight.   ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66b5cfcb-4a97-4131-8cba-96e1be6a35b1/documents/61f4e539-9411-462c-acca-769cdd71de1b_485c0349-a31b-4edc-87e8-d5f9d037296b.html,,,,,, "Distillates (petroleum), light thermal cracked",64741-82-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66b5cfcb-4a97-4131-8cba-96e1be6a35b1/documents/61f4e539-9411-462c-acca-769cdd71de1b_485c0349-a31b-4edc-87e8-d5f9d037296b.html,,oral,LD50,"3,200 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light thermal cracked",64741-82-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66b5cfcb-4a97-4131-8cba-96e1be6a35b1/documents/61f4e539-9411-462c-acca-769cdd71de1b_485c0349-a31b-4edc-87e8-d5f9d037296b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light thermal cracked",64741-82-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66b5cfcb-4a97-4131-8cba-96e1be6a35b1/documents/61f4e539-9411-462c-acca-769cdd71de1b_485c0349-a31b-4edc-87e8-d5f9d037296b.html,,inhalation,LC50,"4,650 mg/m3",adverse effect observed, "Distillates (petroleum), hydrodesulfurized thermal cracked middle",85116-53-6,"No repeat dose toxicity studies have been identified for cracked gas oils, following inhalation or oral exposure. The sub-chronic inhalation study of diesel fuel (OECD 413, a read-across study from VGO/HGO/Distillate Fuels) resulted in a conservative sub-chronic NOAEC of 0.88 mg/L determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of ≥1.71 mg/L was established for systemic effects, based on no significant findings at this level.In a 28-day sub-acute study (OECD 410), dermal exposure to a light catalytically cracked distillate resulted in limited systemic changes and a NOAEL of 500 mg/kg body weight/day.  In a 90-day sub-chronic study (OECD 411), dermal exposure to light catalytically cracked distillate resulted in a systemic NOAEL of 25 mg/kg body weight/day for males, and 125 mg/kg body weight/day for females, based upon reductions in thymus weight.  In another 90-day sub-chronic study (OECD 411), dermal exposure to coker light gas oil resulted in a systemic LOAEL of 30 mg/kg body weight/day for males and females, based upon clinical signs and irritation noted at all doses. ",2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/033a0c1a-8eb3-4c39-a878-6e9039f75353/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_6613264b-4b85-4614-a92c-1988e0752907.html,,,,,, "Distillates (petroleum), hydrodesulfurized thermal cracked middle",85116-53-6,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/033a0c1a-8eb3-4c39-a878-6e9039f75353/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_6613264b-4b85-4614-a92c-1988e0752907.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), hydrodesulfurized thermal cracked middle",85116-53-6,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/033a0c1a-8eb3-4c39-a878-6e9039f75353/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_6613264b-4b85-4614-a92c-1988e0752907.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Distillates (petroleum), hydrodesulfurized thermal cracked middle",85116-53-6,,2025-01-23,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/033a0c1a-8eb3-4c39-a878-6e9039f75353/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_6613264b-4b85-4614-a92c-1988e0752907.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Distillates (petroleum), hydrodesulfurized thermal cracked middle",85116-53-6,"Acute Oral Toxicity:Acute oral toxicity of cracked gas oils was evaluated in male and female rats by a single oral gavage administration of a dose ranging from 2050 to 6250 mg/kg body weight.  Based on mortality and toxicity findings, an oral LD50 of 4660 mg/kg body weight and 3200 mg/kg body weight were reported for males and females, respectively.  Acute Inhalation Toxicity:Acute inhalation toxicity of cracked gas oils in rats was evaluated via whole-body exposure to test material at various measured concentrations for 4 hours.  The acute inhalation LC50 was 4.65 mg/L in males and females. Acute Dermal Toxicity:Acute dermal toxicity of cracked gas oils was evaluated in male and female rabbits at a single dose of 2000 mg/kg body weight.  Based on a lack of adverse systemic effects or mortality, the acute dermal LD50 for light catalytically cracked distillate was >2000 mg/kg body weight.   ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/033a0c1a-8eb3-4c39-a878-6e9039f75353/documents/61f4e539-9411-462c-acca-769cdd71de1b_6613264b-4b85-4614-a92c-1988e0752907.html,,,,,, "Distillates (petroleum), hydrodesulfurized thermal cracked middle",85116-53-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/033a0c1a-8eb3-4c39-a878-6e9039f75353/documents/61f4e539-9411-462c-acca-769cdd71de1b_6613264b-4b85-4614-a92c-1988e0752907.html,,oral,LD50,"3,200 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrodesulfurized thermal cracked middle",85116-53-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/033a0c1a-8eb3-4c39-a878-6e9039f75353/documents/61f4e539-9411-462c-acca-769cdd71de1b_6613264b-4b85-4614-a92c-1988e0752907.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrodesulfurized thermal cracked middle",85116-53-6,,2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/033a0c1a-8eb3-4c39-a878-6e9039f75353/documents/61f4e539-9411-462c-acca-769cdd71de1b_6613264b-4b85-4614-a92c-1988e0752907.html,,inhalation,LC50,"4,650 mg/m3",adverse effect observed, "Distillates (petroleum), C3-6, piperylene-rich",68477-35-0," Repeat dose studies on two C5 non-cyclics streams and two major constituents of these streams have been considered. There is evidence of specific target organ toxicity in several studies. A finding common to several of the studies is kidney changes characteristic of hyaline droplet nephropathy in male rats. This male rat-specific effect is considered not to be relevant to humans. Although C5 non-cyclics streams may contain low levels of benzene and/or toluene, streams containing levels equal to or above 1% would classification for specific target organ systemic toxicity after repeated exposure. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7214efd3-b980-42d9-ba24-a16950002688/documents/IUC5-e2dae253-2c40-4ec7-8171-8bfa2e9516fc_9229c74a-981a-47b4-869e-30a46fdf9073.html,,,,,, "Distillates (petroleum), C3-6, piperylene-rich",68477-35-0," As C5 non-cyclics streams are inherently of unknown and variable composition, and taking into consideration the possible percentages of constituents which are acutely toxic it is proposed that all streams are classified as harmful via oral and dermal exposure routes. Two of the constituents, 2-methyl-2-butene and cyclopentene, are classified as harmful under GHS via the oral route and cyclopentene is also classified as harmful via the dermal route. 2-Methyl-2- butene vapour causes drowsiness and dizziness. Due to their low kinematic viscosity C5 non-cyclics also represent an aspiration hazard. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7214efd3-b980-42d9-ba24-a16950002688/documents/IUC5-4a1915b2-ab0e-4c0e-88eb-eaf7b3efde7f_9229c74a-981a-47b4-869e-30a46fdf9073.html,,,,,, Carbon tetrachloride,56-23-5,"- Repeated dose toxicity, oral:  NOAEL  is 1 mg/kg bw/day for the rat based on effects observed in the liver of male rats at 10 mg/kg bw/day (Many animals studies were available, WOE approach) - Repeated dose toxicity, dermal: no study available - Repeated dose toxicity, inhalation: NOAEC is 32 mg/m³  (= 5 ppm) for the rat and mice, primarily based on liver effects, but also on kidney effects, was selected (Nagano 2007 A&B). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): 4 keys studies are available (Nagano 2007 A&B). All the studies were considered of reliability 1 or 2. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Many animal studies were available. All the studies were considered of reliability 2 or 4. The WoE approach was used. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22e8bf30-90e0-44a3-bb5b-f753a82cdf34/documents/a5e2b763-036a-4e2c-8489-99f97099940d_1f0d9c24-63d5-4e2d-b692-eeb4f6705c43.html,,,,,, Carbon tetrachloride,56-23-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22e8bf30-90e0-44a3-bb5b-f753a82cdf34/documents/a5e2b763-036a-4e2c-8489-99f97099940d_1f0d9c24-63d5-4e2d-b692-eeb4f6705c43.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,1 mg/kg bw/day,,rat Carbon tetrachloride,56-23-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22e8bf30-90e0-44a3-bb5b-f753a82cdf34/documents/a5e2b763-036a-4e2c-8489-99f97099940d_1f0d9c24-63d5-4e2d-b692-eeb4f6705c43.html,Chronic toxicity – systemic effects,inhalation,NOAEC,32 mg/m3,,rat Carbon tetrachloride,56-23-5,"Oral:  Oral LD50 = 2500 mg/kg bw in rat (Similar to OECD 401, K, Rel.2) Dermal: Dermal LD50: > 2000 mg/kg bw in guinea pig (WoE strategy) Inhalation: Inhalation LC50:  > 20 mg/l (46.260 mg/L (= 7228 ppm) for 6 h exposure in rat, upon recalculation, the 4 -h LC50 would be 69,39 mg/L, vapour, K, Rel.2, Similar to OECD 403) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Several studies of different quality are available. The Key study represents the lowest LD50 and was considered sufficiently robust to cover this endpoint. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Several studies of different quality are available. The Key study represents the lowest LC50 and was considered sufficiently robust to cover this endpoint. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Several studies of different quality are available. A WoE strategy was followed. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22e8bf30-90e0-44a3-bb5b-f753a82cdf34/documents/378b1170-b608-4eb2-a104-e7496ca6837f_1f0d9c24-63d5-4e2d-b692-eeb4f6705c43.html,,,,,, Carbon tetrachloride,56-23-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22e8bf30-90e0-44a3-bb5b-f753a82cdf34/documents/378b1170-b608-4eb2-a104-e7496ca6837f_1f0d9c24-63d5-4e2d-b692-eeb4f6705c43.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Carbon tetrachloride,56-23-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22e8bf30-90e0-44a3-bb5b-f753a82cdf34/documents/378b1170-b608-4eb2-a104-e7496ca6837f_1f0d9c24-63d5-4e2d-b692-eeb4f6705c43.html,,dermal,LD50,"2,130 mg/kg bw",no adverse effect observed, Carbon tetrachloride,56-23-5,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22e8bf30-90e0-44a3-bb5b-f753a82cdf34/documents/378b1170-b608-4eb2-a104-e7496ca6837f_1f0d9c24-63d5-4e2d-b692-eeb4f6705c43.html,,inhalation,LC50,69.39 mg/L,no adverse effect observed, 4-vinylcyclohexene,100-40-3,"In a determination of the acute oral toxicity on male and female rats it was found that the LD50 of the test item is 6300 mg/kg of body weight. Under the conditions of this study the acute toxicity of the test item after oral application in rats is very low HÜLS AG, 1985).  ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c23c723-499a-469b-9d82-68b0340d7295/documents/923a9bff-0baa-4659-90c0-d1184c8181cd_5d7d08cb-cc6e-4ebc-8921-24b116eab234.html,,,,,, "2,3-epoxypropyl methacrylate",106-91-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c1b606a-a73e-4740-ac94-ec34e79e577b/documents/IUC5-cb8cb9f5-e9c3-4486-ad35-66603e9bba25_e6009842-9793-4d1d-9842-c4586ac3d28c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "2,3-epoxypropyl methacrylate",106-91-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c1b606a-a73e-4740-ac94-ec34e79e577b/documents/IUC5-cb8cb9f5-e9c3-4486-ad35-66603e9bba25_e6009842-9793-4d1d-9842-c4586ac3d28c.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,30 mg/kg bw/day,,rat "2,3-epoxypropyl methacrylate",106-91-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c1b606a-a73e-4740-ac94-ec34e79e577b/documents/IUC5-cb8cb9f5-e9c3-4486-ad35-66603e9bba25_e6009842-9793-4d1d-9842-c4586ac3d28c.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,12 mg/m3,,rat "2,3-epoxypropyl methacrylate",106-91-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c1b606a-a73e-4740-ac94-ec34e79e577b/documents/IUC5-cb8cb9f5-e9c3-4486-ad35-66603e9bba25_e6009842-9793-4d1d-9842-c4586ac3d28c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,12 mg/m3,adverse effect observed,rat "2,3-epoxypropyl methacrylate",106-91-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c1b606a-a73e-4740-ac94-ec34e79e577b/documents/IUC5-c498d9b3-d6f1-45da-a834-b9860bed298a_e6009842-9793-4d1d-9842-c4586ac3d28c.html,,oral,LD50,597 mg/kg bw,, "2,3-epoxypropyl methacrylate",106-91-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c1b606a-a73e-4740-ac94-ec34e79e577b/documents/IUC5-c498d9b3-d6f1-45da-a834-b9860bed298a_e6009842-9793-4d1d-9842-c4586ac3d28c.html,,dermal,LD50,480 mg/kg bw,, Methylhydrazine,60-34-4," Inhalation: Intermittent chronic exposure (6h/day 5day/week 6 months): LOAEC (dog and monkey - regenerative hemolytic anemia) = 0.2 ppm Intermittent subchronic exposure (6h/day 5d/week 3 months because of invalid controls thereafter): NOEC rats = 0.2 ppm (poorly reliable: no hematological data Continuous subchronic exposure (24h/day 7d/week 3 months): LOAEC (rat and dog - regenerative hemolytic anemia, increase in phosphorus) = 0.0462 ppm Continuous subchronic exposure (24h/day 7d/week 3 months): NOEC (monkey) = 0.1 ppm (medium reliability: several repeated-dose endpoints not investigated) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3cb344b4-f6de-4b79-b110-ef8cf0e802d5/documents/IUC5-4f3d8cae-9c54-44df-a27d-c607a39ee97f_268bb939-6ae0-4ba9-80dc-ec393166bc05.html,,,,,, Methylhydrazine,60-34-4,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3cb344b4-f6de-4b79-b110-ef8cf0e802d5/documents/IUC5-4f3d8cae-9c54-44df-a27d-c607a39ee97f_268bb939-6ae0-4ba9-80dc-ec393166bc05.html,Chronic toxicity – systemic effects,inhalation,LOAEC,0.57 mg/m3,,"other:dog, monkey" Methylhydrazine,60-34-4," Oral: LD50 Rat = 33 mg/kg (reported and peer-reviewed by HSDB) or 71 mg/kg (reported by www.reptox.csst.qc.ca) Inhalation: LC50-4h values: squirrel monkey: 20 ppm, dog: 24 ppm,rhesus monkey: 40 ppm, mouse: 65 ppm, rat: 78 ppm. This range corresponds to 0.038-0.15 mg/L at 25°C, atmospheric pressure. Dermal: LD50 Rat = 183 mg/kg and LD50 Rabbit = 93 mg/kg (both reported and peer-reviewed by HSDB) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cb344b4-f6de-4b79-b110-ef8cf0e802d5/documents/IUC5-7b8b39b8-79cf-4ff8-9b1e-81bc32cc8c0d_268bb939-6ae0-4ba9-80dc-ec393166bc05.html,,,,,, Methylhydrazine,60-34-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cb344b4-f6de-4b79-b110-ef8cf0e802d5/documents/IUC5-7b8b39b8-79cf-4ff8-9b1e-81bc32cc8c0d_268bb939-6ae0-4ba9-80dc-ec393166bc05.html,,oral,LD50,33 mg/kg bw,adverse effect observed, Methylhydrazine,60-34-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cb344b4-f6de-4b79-b110-ef8cf0e802d5/documents/IUC5-7b8b39b8-79cf-4ff8-9b1e-81bc32cc8c0d_268bb939-6ae0-4ba9-80dc-ec393166bc05.html,,dermal,LD50,93 mg/kg bw,adverse effect observed, Methylhydrazine,60-34-4,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cb344b4-f6de-4b79-b110-ef8cf0e802d5/documents/IUC5-7b8b39b8-79cf-4ff8-9b1e-81bc32cc8c0d_268bb939-6ae0-4ba9-80dc-ec393166bc05.html,,inhalation,LC50,150 mg/m3,adverse effect observed, Cadmium hydroxide,21041-95-2,"Available NOAELs from repeated dose oral and inhalation studies range between 0.12 - 3 mg/kg bw/day (studies with cadmium chloride) and 0.013. 10-3- 0.022 x 10-3mg/L (studies with cadmium oxide), respectively.Repeated dose toxicity of cadmium via the dermal route is not expected given the relatively low skin penetration of all forms of this metal. Also in view of the risk reduction measures which need to be taken as a result of the carcinogenicity of cadmium metal and some of the cadmium compounds, chronic dermal toxicity is not expected to be an issue for human health. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e75ae060-7093-4b9f-bdbc-b725bdda6004/documents/IUC5-e534fba1-ace1-4aa0-ba16-db2b5ec41f33_3ef8dceb-315a-4ce0-954b-a143d55fed85.html,,,,,, Cadmium hydroxide,21041-95-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e75ae060-7093-4b9f-bdbc-b725bdda6004/documents/IUC5-e534fba1-ace1-4aa0-ba16-db2b5ec41f33_3ef8dceb-315a-4ce0-954b-a143d55fed85.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.013 mg/m3,,"hamster, Syrian" Cadmium hydroxide,21041-95-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e75ae060-7093-4b9f-bdbc-b725bdda6004/documents/IUC5-e534fba1-ace1-4aa0-ba16-db2b5ec41f33_3ef8dceb-315a-4ce0-954b-a143d55fed85.html,Chronic toxicity – systemic effects,oral,NOAEL,0.12 mg/kg bw/day,,monkey Cadmium hydroxide,21041-95-2,"Although original studies were not available, data for cadmium oxide and cadmium metal powder suggest that the slightly soluble or insoluble forms ofcadmium (like also cadmium hydroxide and cadmium carbonate) may present lower oral acute toxicity than the soluble cadmium compounds. To date, they are not classified for this endpoint. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e75ae060-7093-4b9f-bdbc-b725bdda6004/documents/IUC5-2815b50a-2e19-4afe-845b-9d58de9ac581_3ef8dceb-315a-4ce0-954b-a143d55fed85.html,,,,,, Cadmium hydroxide,21041-95-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e75ae060-7093-4b9f-bdbc-b725bdda6004/documents/IUC5-2815b50a-2e19-4afe-845b-9d58de9ac581_3ef8dceb-315a-4ce0-954b-a143d55fed85.html,,oral,LD50,"2,330 mg/kg bw",, Cadmium hydroxide,21041-95-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e75ae060-7093-4b9f-bdbc-b725bdda6004/documents/IUC5-2815b50a-2e19-4afe-845b-9d58de9ac581_3ef8dceb-315a-4ce0-954b-a143d55fed85.html,,inhalation,LC50,56 mg/m3,, "α-tert-butyl-β-(4-chlorophenoxy)-1H-1,2,4-triazole-1-ethanol",55219-65-3,"Oral acute toxicity study in Wistar rats. Study prior to GLP, equivalent to OECD guideline 401, the acute oral LD50 were calculated to be 689 mg/kg bw and 752 mg/kg bw in fasted males and females’ rats, respectively. In unfasted rats, oral LD50 were calculated to be 1098 mg/kg bw and 1037 mg/kg bw in males and females, respectively. The substance is classified Category 4 based on the CLP regulation. Dermal acute toxicity in Wistar rats. According to OECD guideline 402 the dermal LD50 of the test item was determined to be >2000 mg/kg bw and regarded as nontoxic after dermal application. The substance is not classified by the CLP regulation. Inhalation acute toxicity in Wistar rats. Study prior to GLP, equivalent to OECD guideline 403, the acute inhalation LC50 was calculated to be >954 mg/m3 based on the four-hour exposure. The substance is not classified by the CLP regulation.         ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e60f1973-0d82-4508-842a-c2851d1e1889/documents/10660c52-8312-45e3-93a5-db9cc4a66e3f_ac88d245-916b-42cc-afbb-34a066d463ca.html,,,,,, "α-tert-butyl-β-(4-chlorophenoxy)-1H-1,2,4-triazole-1-ethanol",55219-65-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e60f1973-0d82-4508-842a-c2851d1e1889/documents/10660c52-8312-45e3-93a5-db9cc4a66e3f_ac88d245-916b-42cc-afbb-34a066d463ca.html,,oral,LD50,689 mg/kg bw,adverse effect observed, "α-tert-butyl-β-(4-chlorophenoxy)-1H-1,2,4-triazole-1-ethanol",55219-65-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e60f1973-0d82-4508-842a-c2851d1e1889/documents/10660c52-8312-45e3-93a5-db9cc4a66e3f_ac88d245-916b-42cc-afbb-34a066d463ca.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "α-tert-butyl-β-(4-chlorophenoxy)-1H-1,2,4-triazole-1-ethanol",55219-65-3,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e60f1973-0d82-4508-842a-c2851d1e1889/documents/10660c52-8312-45e3-93a5-db9cc4a66e3f_ac88d245-916b-42cc-afbb-34a066d463ca.html,,inhalation,LC50,> 954 mg/m3,no adverse effect observed, Thiacloprid,111988-49-9," Oral repeated dose toxicity   Rats Key, M-030427-03-1, OECD 407, rat, 21 d, NOAEL: 100 ppm (corresponding to 9.0 mg/kg bw/day for males and 12.3 mg/kg bw/day for females) LOAEL: 400 ppm (corresponding to 36.9 mg/kg bw/day for males and 44.6 mg/kg bw/day for females)   Key, M-000863-01-1, OECD 408, rat, 13 weeks, NOAEL: 100 ppm (corresponding to 7.3 mg/kg bw/day for males and and 7.6 mg/kg bw/day females) LOAEL: 400 ppm (corresponding to 28.6 mg/kg bw/day for males and 35.6 mg/kg bw/day for females)   Key, M-003817-02-1, OECD 453, rat, 2 years, NOAEL: 25 ppm (males, corresponding to 1.2 mg/kg bw/day) and 50 ppm (females, corresponding to 3.3 mg/kg bw/day) LOAEL: 50 ppm (males, corresponding to 2.5 mg/kg bw/day) and 500 ppm (females, corresponding to 33.5 mg/kg bw/day)   Mice WoE, M-000821-01-1, OECD 407, mice, 14d, NOAEL: 200 ppm (corresponding to 84.3 mg/kg bw/day for males and 113.1 mg/kg bw/days for females) LOAEL: 2000 ppm (corresponding to 765.1 mg/kg bw/day for males and 1201.2 mg/kg bw/days for females)   WoE, M-000688-01-1, OECD 407, mice, 21d, NOAEL: 100 ppm (corresponding to 30.1 mg/kg bw/day for males and 63.9 mg/kg bw/days for females) LOAEL: 1000 ppm (corresponding to 367.8 mg/kg bw/day for males and 559.3 mg/kg bw/days for females)   Key, M-000697-02-1, OECD 408, mice, 14 weeks, NOAEL: 50 ppm (males, corresponding to 19.9 mg/kg bw/day), no NOAEL established for females, LOAEL: 250 ppm (males, corresponding to 102.6 mg/kg bw/day) and 50 ppm (females, corresponding to 27.2 mg/kg bw/day)   Dogs Key, M-003814-01-1, OECD 409, dogs, 13 weeks, NOAEL: 250 ppm (males, corresponding to 8.5 mg/kg bw/day), 2000 ppm (females, corresponding to 65.3 ppm) LOAEL: 1000 ppm (males, corresponding to 34.9 mg/kg bw/day)   Key, M-003818-01-1, OECD 452, dogs, 52 weeks, NOAEL: 250 ppm (males, corresponding to 8.88 mg/kg bw/day), 1000 ppm (females, corresponding to 33.8 mg/kg bw/day) LOAEL: 1000 ppm (males, corresponding to 34.42 mg/kg bw/day)   Inhalation repeated dose toxicity Key, M-241815-01-1, similar to OECD 412, rat, 28 d, NOAEC (systemic): 18.2 mg/m³ (dust) LOAEC (systemic): 143.2 mg/m³ (dust) NOAEC (respiratory system, local): 143.2 mg/m³ (dust)   Dermal repeated dose toxicity Key, M-000824-01-1, OECD 410, rat, 28 d, NOAEL (systemic, males): 100 mg/kg bw/day, LOAEL (systemic, males): 300 mg/kg bw/day NOAEL (systemic, females): 300 mg/kg bw/day, LOAEL (systemic, females): 1000 mg/kg bw/day NOAEL (dermal, local, males, females): 1000 mg/kg bw/day ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2a16cf0-6161-40b5-990f-0c712fa314dc/documents/8047c047-1a21-4d7d-94e7-c9eec2d99885_fa8d672a-9517-4749-b088-dfe31390c69f.html,,,,,, Thiacloprid,111988-49-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2a16cf0-6161-40b5-990f-0c712fa314dc/documents/8047c047-1a21-4d7d-94e7-c9eec2d99885_fa8d672a-9517-4749-b088-dfe31390c69f.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,,rat Thiacloprid,111988-49-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2a16cf0-6161-40b5-990f-0c712fa314dc/documents/8047c047-1a21-4d7d-94e7-c9eec2d99885_fa8d672a-9517-4749-b088-dfe31390c69f.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,18.2 mg/m3,,rat Thiacloprid,111988-49-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2a16cf0-6161-40b5-990f-0c712fa314dc/documents/8047c047-1a21-4d7d-94e7-c9eec2d99885_fa8d672a-9517-4749-b088-dfe31390c69f.html,Chronic toxicity – systemic effects,oral,NOAEL,1.2 mg/kg bw/day,,rat Thiacloprid,111988-49-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2a16cf0-6161-40b5-990f-0c712fa314dc/documents/8047c047-1a21-4d7d-94e7-c9eec2d99885_fa8d672a-9517-4749-b088-dfe31390c69f.html,Repeated dose toxicity – local effects,dermal,NOAEL,6.7 mg/cm2,no adverse effect observed,rat Thiacloprid,111988-49-9,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2a16cf0-6161-40b5-990f-0c712fa314dc/documents/8047c047-1a21-4d7d-94e7-c9eec2d99885_fa8d672a-9517-4749-b088-dfe31390c69f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,143.4 mg/m3,no adverse effect observed,rat Thiacloprid,111988-49-9," Oral (US-EPA-FIFRA, Guideline 81-8(SS)), rat: LD50 = 177 mg/kg bw (males and females) Inhalation (OECD 403), rat: LC50 > 2.535 mg/L (males) and LC50 = ca. 1.223 mg/L (females) Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw (males and females) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2a16cf0-6161-40b5-990f-0c712fa314dc/documents/3c19ec66-858d-47d5-8254-d59ae8d9c892_fa8d672a-9517-4749-b088-dfe31390c69f.html,,,,,, Thiacloprid,111988-49-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2a16cf0-6161-40b5-990f-0c712fa314dc/documents/3c19ec66-858d-47d5-8254-d59ae8d9c892_fa8d672a-9517-4749-b088-dfe31390c69f.html,,oral,LD50,177 mg/kg bw,adverse effect observed, Thiacloprid,111988-49-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2a16cf0-6161-40b5-990f-0c712fa314dc/documents/3c19ec66-858d-47d5-8254-d59ae8d9c892_fa8d672a-9517-4749-b088-dfe31390c69f.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Thiacloprid,111988-49-9,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2a16cf0-6161-40b5-990f-0c712fa314dc/documents/3c19ec66-858d-47d5-8254-d59ae8d9c892_fa8d672a-9517-4749-b088-dfe31390c69f.html,,inhalation,LC50,ca.1.223 mg/L,adverse effect observed, "Distillates (coal tar), benzole fraction",84650-02-2,The oral LD50 of light oil is greater than 2000 mg/kg bw. ,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be40bf57-d9d9-40b4-863c-63526916dcb6/documents/IUC5-72bdac67-3b2f-4c7f-bc45-35e021c49fba_fb2ede32-3e2a-4ade-b152-dab990f44f6e.html,,,,,, Piperazine,110-85-0," Two dietary 90 -day studies are available, one in rats and one in dogs. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3994d289-6fa4-4f57-8e26-f3e6a7d8a4bb/documents/IUC5-7a827ec6-1bcf-48a9-8c5c-c3c847349aef_603da277-9979-4a81-a5e8-752756b2b74f.html,,,,,, Piperazine,110-85-0,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3994d289-6fa4-4f57-8e26-f3e6a7d8a4bb/documents/IUC5-7a827ec6-1bcf-48a9-8c5c-c3c847349aef_603da277-9979-4a81-a5e8-752756b2b74f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,627 mg/kg bw/day,,rat Piperazine,110-85-0," Piperazine has shown low toxicity in acute oral and dermal toxicity tests: LD50 oral, rat = 2600 mg/kg bw and LD50 dermal, rabbit = 8300 mg/kg bw. In acute inhalation toxicity tests (inhalation hazard tests) rats were exposed to the vapour; no LC50 was determined. At 1.61 mg/l exposure for 7 h slight mucosal irritation was noted. No clinical signs were noted at inhalation exposure of 0.57 mg/l for 7 h.     ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3994d289-6fa4-4f57-8e26-f3e6a7d8a4bb/documents/08fbb4b3-3aa3-42e2-8ffd-6d5e671a0882_603da277-9979-4a81-a5e8-752756b2b74f.html,,,,,, Piperazine,110-85-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3994d289-6fa4-4f57-8e26-f3e6a7d8a4bb/documents/08fbb4b3-3aa3-42e2-8ffd-6d5e671a0882_603da277-9979-4a81-a5e8-752756b2b74f.html,,oral,LD50,"2,600 mg/kg bw",no adverse effect observed, Piperazine,110-85-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3994d289-6fa4-4f57-8e26-f3e6a7d8a4bb/documents/08fbb4b3-3aa3-42e2-8ffd-6d5e671a0882_603da277-9979-4a81-a5e8-752756b2b74f.html,,dermal,LD50,"8,300 mg/kg bw",no adverse effect observed, Piperazine,110-85-0,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3994d289-6fa4-4f57-8e26-f3e6a7d8a4bb/documents/08fbb4b3-3aa3-42e2-8ffd-6d5e671a0882_603da277-9979-4a81-a5e8-752756b2b74f.html,,inhalation,LC0,> 2 mg/L,no adverse effect observed, Boldenone,846-48-0,"Oral (Rat, GLP): LD50 > 2000 mg/kg[Bayer Schering Pharma AG, Report No. A49531, 2010-06-14]Dermal (Rat, GLP): LD50 > 2000 mg/kg[Bayer Schering Pharma AG, Report No. A49585, 2010-06-17] ",2025-01-23,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5cb4b50-6fb1-4f01-933c-452ad4349bb7/documents/IUC5-4b8a90a9-4d64-4cc7-8ce9-de99f9269075_812361bd-86d7-445a-8351-11dc985ef7c3.html,,,,,, Potassium titanium oxide (K2Ti6O13),12056-51-8, Repeated dose toxicity studies by inhalation are relevant for the hazard assessment of the substance. Overall the NOAEL of 500 mg/m3 shall be considered for local lung effects. The biopersistence of fibers in the lungs seems to depend on fiber morphology. ,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/242b2861-2ff0-4a68-a8f9-ea2cded05ade/documents/e8988d88-1693-4c8d-8bf4-1c32048c9691_86f99b6d-e0a7-43e0-9801-f95e85093c5a.html,,,,,, Potassium titanium oxide (K2Ti6O13),12056-51-8," The oral and inhalation routes were chosen as the most appropriate routes of administration for acute toxicity studies for the substance, having regard to the likely route of human exposure. The acute toxicity of the test material was investigated, by the (i) oral and (ii) inhalation routes, in studies which were conducted under GLP conditions and in accordance with the standardised guidelines. The acute oral median lethal dose (LD50) of the test material in male/female Wistar rat was estimated to be greater than 2000 mg/kg bodyweight in two studies. In the acute inhalation study, the acute inhalation median lethal concentration (4 h LC50) of the substance in the male/female Fisher 344 strain rat was greater than 1.9 mg/L (aerosol of the substance).  No deaths occurred in neither of the studies. In a study via intra-tracheal installation,the biological half-life of TOFIX-S in the rat lung after a single intra-tracheal instillation was found to be 2.3 months, consistent, the author noted, with particulate materials having little biological effect. No production of 8-hydroxydeoxyguanosine (an indicator of oxidative damage caused by active oxygen species) was observed, no significant differences in gene expression of TIMP-2 (Tissue Inhibitors of MetalloProteins) was found (suggesting that the substance has little effect on inflammation and fibrosis), and no significant changes were noted in histopathological examination of the lungs. Data from the literature show that the shape of the fibers is relevant in determinig lung effects after intratracheal instillation (Ishihara et al, 2002). Moreover, acute inflammatory response may reflect the effects observed after reapeated dose exposure to fibrous material (Morimoto et al, 2001). ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/242b2861-2ff0-4a68-a8f9-ea2cded05ade/documents/5f23449a-04c8-42c8-993f-b3fa76f652a6_86f99b6d-e0a7-43e0-9801-f95e85093c5a.html,,,,,, Potassium titanium oxide (K2Ti6O13),12056-51-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/242b2861-2ff0-4a68-a8f9-ea2cded05ade/documents/5f23449a-04c8-42c8-993f-b3fa76f652a6_86f99b6d-e0a7-43e0-9801-f95e85093c5a.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Potassium titanium oxide (K2Ti6O13),12056-51-8,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/242b2861-2ff0-4a68-a8f9-ea2cded05ade/documents/5f23449a-04c8-42c8-993f-b3fa76f652a6_86f99b6d-e0a7-43e0-9801-f95e85093c5a.html,,inhalation,discriminating conc.,"> 1,900 mg/m3",no adverse effect observed, Molybdenum trioxide,1313-27-5,"NOAEL for systemic toxicity, oral, from a sub-chronic study with sodium molybdate dihydrate in rats (Hoffman, 2011): 17 mg Mo/kg bw/day. Unbounded NOAEC for systemic toxicity, inhalation, from a sub-chronic study with molybdenum trioxide in rats and mice (NTP, 1997): 66.7 mg Mo/m³. Important: both values expressed based on element Mo (for read-across purposes), not on the respective test substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56e55588-ebbb-49f0-9dae-0792ba58acd9/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_27b5f81b-0a8b-45c7-b18c-505c6aa5ec69.html,,,,,, Molybdenum trioxide,1313-27-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56e55588-ebbb-49f0-9dae-0792ba58acd9/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_27b5f81b-0a8b-45c7-b18c-505c6aa5ec69.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat Molybdenum trioxide,1313-27-5,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56e55588-ebbb-49f0-9dae-0792ba58acd9/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_27b5f81b-0a8b-45c7-b18c-505c6aa5ec69.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,66.7 mg/m3,,other:rats and mice Molybdenum trioxide,1313-27-5," To avoid unnecessary (animal) testing, a comprehensive grouping and read-across concept has been developed amongst several molybdenum containing substances. Acute oral, inhalation and dermal toxicity studies are available for several but not all substances in the category. The following LD50s are therefore either based on test data for the substance in this dossier, or based on read-across within the category: For molybdenum trioxide: LD50 oral: 2689 mg/kg (male), 3830 mg/kg (female)  (based on study with this substance) LD50 inhalation, 4h: > 5.84 g/m³ (based on study with this substance) LD50 dermal: > 2000 mg/kg (based on study with this substance) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56e55588-ebbb-49f0-9dae-0792ba58acd9/documents/IUC5-748668e1-7f5f-442f-87ce-8650361f7ea4_27b5f81b-0a8b-45c7-b18c-505c6aa5ec69.html,,,,,, Hydroxylamine,7803-49-8,"For hydroxylamine (free base) no data is available. However, valid studies of the corresponding salt ""hydroxylamine sulfate"" are available:CAS No. 10039-54-0:oral- 90 d, rat, oral: NOAEL = > 0.9 mg/kg bw/d (nominal) for males and females (BASF AG 1989, Val. 2)- 28 d, rat, oral: NOAEL = 25 ppm for males and 100 ppm for females (BASF AG 1989, Val. 2)- 12 months, rat, oral: NOAEL = 0.2/0.3 mg/kg bw/d in males and 0.4 mg/kg bw/d in females for systemic effects (BASF 2001, Val. 1)- 12 weeks, mice, oral: LOAEL = 100 mg/kg bw/d in males and 0.4 mg/kg bw/d in females for systemic effects (Yamamoto 1967, Val. 3)- 7 and 28 d, rat, oral: no NOAEL determined: mechanistical study and no guideline study, therefore no effect levels determined (BASF 2003, Val. 1) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d0bbdb0-b4d2-4f41-8252-9a7a917d9652/documents/IUC5-170c8778-cafa-46e2-aa37-35942c81976a_f3ac5eee-4fad-41eb-a464-ab80336acd16.html,,,,,, Hydroxylamine,7803-49-8,"For hydroxylamine (free base) no data is available. However, valid studies of the corresponding salts ""hydroxylamine sulfate"" and ""hydroxylamine chloride"" are available:CAS No. 10039-54-0:OralRat:LD50 = 642 mg/kg bw (BASF 1969, Val. 2)LD50 ca. 3160 mg/kg bw (BASF 1975, Val. 3) Cat:LD50 > 50 and < 200 mg/kg bw for females and > 200 mg/kg bw for males (BASF 1981, Val. 2)InhalationRat, IHT: 8 h: No mortality occurred at room temperature (BASF 1969, Val. 3) Rat, IHT: 7 h: No mortality occurred at room temperature (BASF 1980, Val. 3) Rat, IHT: 8 h: No mortality occurred at room temperature (BASF 1975, Val. 3) Dermal- Rat: LD50 > 500 mg/kg bw (Derelanko 1987, Val. 1; occlusive test conditions)- Rabbit: LD50 > 1000 mg/kg bw (Derelanko 1987, Val. 1; semiocclusive test conditions)LD50 > 100 and < 500 mg/kg bw (Derelanko 1987, Val. 1; occlusive test conditions)LD50 > 400 mg/kg bw (BASF 1980, Val. 2)LD50 > 1500 and < 2000 mg/kg bw (Allied Corp. 1983, Val.1; semiocclusive test conditions).CAS No. 5470-11-1:OralRat:LD50 ca. 600 mg/kg bw (BASF AG 1975, Val. 2)Mouse:LD50 ca. 408 mg/kg bw in males and 419 mg/kg bw in females (Riemann 1950, Val. 2)InhalationRat, IHT: 8 h: No mortality occurred at room temperature (BASF 1975, Val. 3) DermalNo data available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d0bbdb0-b4d2-4f41-8252-9a7a917d9652/documents/IUC5-f3630ec8-9a53-4517-a34b-9bcde2d8138e_f3ac5eee-4fad-41eb-a464-ab80336acd16.html,,,,,, "1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole",60207-90-1,"- Oral: NOAEL = 240 ppm (dietary equivalent to 15.9 and 16.8 mg/kg bw/day for males and females, respectively), rats, sub-chronic, 90 days, dietary, Sachsse 1979. - Oral: NOAEL ≥ 250 ppm (8.4 and 8.9 mg/kg bw/day for males and females, respectively), dogs, sub-chronic, 1 year, dietary, Johnson 1985 - Oral: NOAEL = 600 ppm (dietary equivalent to 38 mg/kg bw/day) in males and 1500 ppm (dietary intake of 111 mg/kg bw/day) in females, rats, sub-chronic, 13 weeks, dietary, OECD TG 424, Herberth 2013a Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): In line with current guideline standards ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/139c835f-afe4-430d-841a-61747eb86c58/documents/a0af92ca-b531-4e07-9de6-d50af684e665_8e5a75bd-8635-44ca-90bf-2e67bc8914e0.html,,,,,, "1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole",60207-90-1,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/139c835f-afe4-430d-841a-61747eb86c58/documents/a0af92ca-b531-4e07-9de6-d50af684e665_8e5a75bd-8635-44ca-90bf-2e67bc8914e0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15.9 mg/kg bw/day,,rat "1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole",60207-90-1,"- Oral: LD50 = 550 mg/kg bw, female, rat, according to OECD TG 425, Tavazsi 2010 - Inhalation: LD50 > 5836 mg/m3, male/female, rats, according to OECD TG 403, Hartmann 1988 - Dermal: LC50 > 5000 mg/kg bw, male/female, rats, according to OECD TG 402, Zelenak 2010 Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP compliant OECD TG 425 study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): GLP compliant OECD TG 403 study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): GLP compliant OECD TG 402 study ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/139c835f-afe4-430d-841a-61747eb86c58/documents/0fd7912d-4a50-40b7-9462-8dcf40fa1b1d_8e5a75bd-8635-44ca-90bf-2e67bc8914e0.html,,,,,, "1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole",60207-90-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/139c835f-afe4-430d-841a-61747eb86c58/documents/0fd7912d-4a50-40b7-9462-8dcf40fa1b1d_8e5a75bd-8635-44ca-90bf-2e67bc8914e0.html,,oral,LD50,550 mg/kg bw,adverse effect observed, "1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole",60207-90-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/139c835f-afe4-430d-841a-61747eb86c58/documents/0fd7912d-4a50-40b7-9462-8dcf40fa1b1d_8e5a75bd-8635-44ca-90bf-2e67bc8914e0.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl]methyl]-1H-1,2,4-triazole",60207-90-1,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/139c835f-afe4-430d-841a-61747eb86c58/documents/0fd7912d-4a50-40b7-9462-8dcf40fa1b1d_8e5a75bd-8635-44ca-90bf-2e67bc8914e0.html,,inhalation,discriminating conc.,"5,836 mg/m3",no adverse effect observed, mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt  ,8018-01-7,"Based on the results of a two-year combined chronic toxicity study/carcinogenicity study, the NOAEL of the test substance was determined to be 4.8 mg/kg bw/d. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study is acceptable for assessment. It was conducted according to OECD Guideline 453 and Directive 87/302/EECpart B ‘’ Combined chronic toxicity/oncogenicity’ and in compliance with GLP. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f3e3a50-e851-4485-86ef-b63e098cea65/documents/5088344a-7dc4-4adf-9756-5570a58a5f67_0d17cb71-df27-453f-9eed-ea4787bd53a4.html,,,,,, mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt  ,8018-01-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f3e3a50-e851-4485-86ef-b63e098cea65/documents/5088344a-7dc4-4adf-9756-5570a58a5f67_0d17cb71-df27-453f-9eed-ea4787bd53a4.html,Chronic toxicity – systemic effects,oral,NOAEL,4.8 mg/kg bw/day,,rat mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt  ,8018-01-7," In the acute oral toxicity study no adverse effects have been observed and a discriminating dose > 2000 mg/kg bw was determined for rats. The substance was tested for inhalation toxicity in rats in a 4 h head-only inhalation study according to OECD TG 403. The acute inhalation median lethal concentration (4hr LC50) value to rat was found to be more than the maximum achieved concentration of the test item dust aerosol viz.,1.766 mg/L of air at breathing zone. The acute dermal median lethal dose (LD50) of the test item to Wistar rat was found to be more than 2000 mg/kg body weight. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f3e3a50-e851-4485-86ef-b63e098cea65/documents/55245e0b-19cb-4d75-aa7c-39f3c056f040_0d17cb71-df27-453f-9eed-ea4787bd53a4.html,,,,,, mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt  ,8018-01-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f3e3a50-e851-4485-86ef-b63e098cea65/documents/55245e0b-19cb-4d75-aa7c-39f3c056f040_0d17cb71-df27-453f-9eed-ea4787bd53a4.html,,oral,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt  ,8018-01-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f3e3a50-e851-4485-86ef-b63e098cea65/documents/55245e0b-19cb-4d75-aa7c-39f3c056f040_0d17cb71-df27-453f-9eed-ea4787bd53a4.html,,dermal,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, mancozeb (ISO); manganese ethylenebis(dithiocarbamate) (polymeric) complex with zinc salt  ,8018-01-7,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f3e3a50-e851-4485-86ef-b63e098cea65/documents/55245e0b-19cb-4d75-aa7c-39f3c056f040_0d17cb71-df27-453f-9eed-ea4787bd53a4.html,,inhalation,discriminating conc.,> 1.766 mg/L,no adverse effect observed, Nickel bis(sulphamidate),13770-89-3," Value used for CSA (read-across from Nickel sulphate): NOAEL (oral, systemic, animal): 10 mg Ni sulphate hexahydrate /kg bw/day (or 2.2 mg Ni/kg bw/day) (Heim et al. 2007) NOAEC (inhalation, local, animal): 0.12 mg Ni sulphate hexahydrate /m³ air ( or 0.027 mg Ni/m3air) (Dunnick et al., 1995) LOAEC (inhalation, local, animal): 0.25 mg nickel sulphate hexahydrate/m3(or 0.056 mg Ni/m3)(Dunnick et al., 1995) Target organs: respiratory: lung ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6d37bfe-c736-4675-a977-b9fcbbec1519/documents/c053c552-2570-4304-8c98-b6ce3f387ca7_151dcd77-728d-4286-8f2e-bad61f86e58a.html,,,,,, Nickel bis(sulphamidate),13770-89-3," Value used for CSA: NOAEL (oral, systemic, animal): 550 mg/kg bw(96 mg Ni/kg bw/day) (EPSL, 2008) LOAEL (oral, systemic, human data; read-across): 0.012 mg Ni (Ni ion)/kg bw/day released from metallic nickel in water and food contact material (Nielsen et al 1999) NOAEC (inhalation, systemic, animal; read-across): 0.53 mg NiSO4.6H2O/L air (120 mg Ni/m3) (EPSL, 2009) LOAEC (inhalation, local, animal; read-across): 0.7 mg Ni/m3(DNEL calculation is based on 16-day repeated dose study-Benson et al, 1988; no acute data was available) An acute local inhalation DNEL is derived based on the lung effects (e.g. lung inflammation) associated with nickel sulphate inhalation.  The shortest-term study available examining those effects in animals is a 16-day repeated exposure study.  An adjustment factor was derived to extrapolate the results from the repeated exposure study to an equivalent effect concentration in a 4 hr acute exposure.  SeeAppendix C3for more information. (Oral, local values are not applicable; Dermal, local or systemic, values are not applicable) ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6d37bfe-c736-4675-a977-b9fcbbec1519/documents/6b59a956-a702-4145-8ede-9ce4ac47cb67_151dcd77-728d-4286-8f2e-bad61f86e58a.html,,,,,, Dicyclohexyl phthalate,84-61-7,"Since a slight increase in liver weight was observed at 0.15 % and higher, a more conservative no-effect level, on the basis of all information available, is 0.1%, which is approximately equivalent with an intake of 50mg/kg body weight/day. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4742a866-2c9d-40f3-b353-f6d166324c0d/documents/IUC5-593d0de5-aad5-49da-ab18-460867167723_e15fb14e-d558-465c-ba63-11a1b792aa74.html,,,,,, Dicyclohexyl phthalate,84-61-7,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4742a866-2c9d-40f3-b353-f6d166324c0d/documents/IUC5-593d0de5-aad5-49da-ab18-460867167723_e15fb14e-d558-465c-ba63-11a1b792aa74.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Dicyclohexyl phthalate,84-61-7,"Oral, LD50 > 2000 mg/kg bw , rat (OECD 423 )Dermal, LD50 > 2000 mg/kg bw , rat (OECD 402 )In accordance with column 2 of REACH Annex VIII, the acute toxicity by inhalation study (required in section 8.5.2) does not need to be conducted as acute toxicity studies are available for the oral and dermal routes of exposure. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4742a866-2c9d-40f3-b353-f6d166324c0d/documents/IUC5-29c79852-3912-4f31-8f62-c584805c6337_e15fb14e-d558-465c-ba63-11a1b792aa74.html,,,,,, Cyanamide,420-04-2,"Results in subacute studies: Oral (gavage), 28 days, rat: Depression in body weights, body weight gains and food consumption at 20 and 40 mg/kg bw/day. Histopathological findings in thyroid, liver and spleen at 10, 20 and 40 mg/kg bw/day. No effects in the lowest dose. NOAEL: 5 mg/kg bw/day Dermal 21 days, rabbit: Substance related effects in organ weights (heart, liver, kidney and testes) and microscopic and macroscopic changes in some organs in both sexes. No relevant treatment related effects at lower doses. NOAEL: 25 mg/kg bw/day Inhalation 14 days, rat: Decrease in weights and variations in food consumption were observed in all dose groups treated with the substance. Macroscopic and microscopic effects in brain, lungs, heart and liver were observed at the high dose group in m/f rats. No relevant treatment related effects at the low and mid-dose group. NOAEL: 0.2629 g/m³   Results in subchronic studies: Oral (feeding), 90 days, rat: Marked effects in the thyroid in males and in females at 4.5 mg/kg bw/day; additionally increases in erythrocyte counts. NOAEL: 1.5 mg/kg bw/day Oral (gavage), 90 days, dogs: Slight anemia correlated with a slight hypothyroidism and a slight monocytosis found at 2 and 6 mg/kg bw in both sexes. Microscopic examination revealed marked changes at 6 mg/kg bw in the testes together with a reduced testes weight. No substance related effects at 0.6 mg/kg bw/day in male and female dogs. NOAEL: 0.6 mg/kg bw/day Oral (gavage), 90 days, dogs: Decrease of body weight and testes weight; microscopic and macroscopic changes were observed at the higher dose group. No substance related effects at 0.6 mg/kg bw/day in male and female dogs. NOAEL: 0.6 mg/kg bw/day   Results in chronic studies: The NOAEL of pure active substance cyanamide is 1.0 mg/kg bw/day in beagle dogs. The NOAEL of pure active substance cyanamide is 1.0 mg/kg bw/day in Sprague-Dawley rats. Peer Review Review of the studies support that the NOAEL of 1 mg/kg bw/day observed in the one year dog study is the relevant starting point for a DNEL derivation. Classification as STOT RE2 (thyroid) is triggered based on a detailed evaluation by RAC considering siginificant effects on thyroid particular in the rat but also in the dog. The conclusion takes into account the particular sensitivity of rats as well as evidence of probable higher sensitivity of dogs compared to humans. The apparent lack of adverse effects on the thyroid from the cyanamide treated human population is also considered as supportive information. In addition, a relation between the effects on thyroid observed in vivo and the effects observed in current TPO inhibition studies on rat/dog/humans in vitro cannot be excluded. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Only one reliable study available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): reliable scientifically acceptable study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 6 studies (acute to chronic) with aqueous solution of cyanamide in two species (rat and dog) ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e4f4c86-bb7c-4a6f-98a7-e68b0b54a973/documents/b01689ba-37fe-42a8-b07b-9577c25de68f_ae8fa698-16de-4e16-ac31-38572bf1a5f9.html,,,,,, Cyanamide,420-04-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e4f4c86-bb7c-4a6f-98a7-e68b0b54a973/documents/b01689ba-37fe-42a8-b07b-9577c25de68f_ae8fa698-16de-4e16-ac31-38572bf1a5f9.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,25 mg/kg bw/day,,rabbit Cyanamide,420-04-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e4f4c86-bb7c-4a6f-98a7-e68b0b54a973/documents/b01689ba-37fe-42a8-b07b-9577c25de68f_ae8fa698-16de-4e16-ac31-38572bf1a5f9.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,0.263 mg/m3,,rat Cyanamide,420-04-2,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e4f4c86-bb7c-4a6f-98a7-e68b0b54a973/documents/b01689ba-37fe-42a8-b07b-9577c25de68f_ae8fa698-16de-4e16-ac31-38572bf1a5f9.html,Chronic toxicity – systemic effects,oral,NOAEL,1 mg/kg bw/day,,dog Cyanamide,420-04-2,"Technical active cyanamide (hydrogen cyanamide/ L500, a 50% aqueous solution) was examined in two acute oral studies, one acute dermal toxicity study and in one acute inhalation toxicity study. The obtained results (LD50 values) were extrapolated for the pure active cyanamide (Cyanamid F1000) and were considered to be moderately toxic via the oral (LD50: 142 mg/kg bw/d) and the dermal (LD50: 848 mg/kg bw/d) route and practically not toxic via the inhalation route (LC50 >1 mg/L). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): 2 GLP and guideline studies available Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Only one GLP and guideline compliant study available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Only one GLP and guideline compliant study available. ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e4f4c86-bb7c-4a6f-98a7-e68b0b54a973/documents/d3c2e87f-b8e7-4fb6-a62a-08fbf2de583a_ae8fa698-16de-4e16-ac31-38572bf1a5f9.html,,,,,, Cyanamide,420-04-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e4f4c86-bb7c-4a6f-98a7-e68b0b54a973/documents/d3c2e87f-b8e7-4fb6-a62a-08fbf2de583a_ae8fa698-16de-4e16-ac31-38572bf1a5f9.html,,oral,LD50,142 mg/kg bw,adverse effect observed, Cyanamide,420-04-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e4f4c86-bb7c-4a6f-98a7-e68b0b54a973/documents/d3c2e87f-b8e7-4fb6-a62a-08fbf2de583a_ae8fa698-16de-4e16-ac31-38572bf1a5f9.html,,dermal,LD50,848 mg/kg bw,adverse effect observed, Cyanamide,420-04-2,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e4f4c86-bb7c-4a6f-98a7-e68b0b54a973/documents/d3c2e87f-b8e7-4fb6-a62a-08fbf2de583a_ae8fa698-16de-4e16-ac31-38572bf1a5f9.html,,inhalation,LC50,"1,000 mg/m3",no adverse effect observed, Phosmet,732-11-6,"The toxicologically relevant and most sensitive finding in the oral short-term toxicity studies in mice, rats and dogs is the Phosmet-related inhibition of Cholinesterase (ChE) activity in plasma, red blood cells and brain.   Subacute studies (28 days) carried out in mouse and dog revealed that the dog is more sensitive to Phosmet. The most important and signalled as a critical effect was the depression of the Cholinesterase (ChE) activity exerted by Phosmet at low doses. Dog was affected at the dose of 3 mg/Kg bw/day where a >20% inhibition of the red blood cell cholinesterase activity was evident, however brain and plasma ChEs begin to show such a depression at 6mg/kg bw/day. Therefore, the NOAEL of this study is deduced to be 1.5 mg/kg bw/day, based on the biologically relevant inhibition of the erythrocytes Acetylcholinesterase. Mouse dosed with 12 mg/Kg bw/day showed a noticeable depression of red blood cell (RBC) and brain ChE. When the mouse are dosed with 25.7 mg/Kg bw/day, the body weight and food consumption were decreased and incipient changes of relative/absolute organ weight are seen. When Phosmet was tested in rats and dogs for 90 days, the critical effect was the depression of the Plasma, RBC and brain Cholinesterases and no other effects were observed at the studied doses. In rat, important depression of the blood ChE enzyme was observed when dosed at 10 mg/Kg bw/day and since week 2 of dosing and the depression of the brain ChE was evident at the day 90. By the other hand, dogs was affected by the systemic dose of 14.08 mg/Kg bw/day, at which, an important RBC ChE depression was observed from week 1 onwards.   An overall lowest oral NOAEL of 2 mg/kg bw/d can be identified as critical dose descriptor based on 90-day oral toxicity studies in rats and dogs, supported by the outcomes of dose range-finding toxicity studies in mice and dogs. This overall NOAEL is based on biologically significant ChE activity inhibition (i.e. >20 % inhibition).   Phosmet, administered topically for 3 weeks on rats and rabbits produced inhibition of brain ChE activity in rats at the dose of 60 mg/Kg bw/day and inhibition of the RBC ChE in rabbits at the dose of 100 mg/Kg bw/day and therefore, the critical dermal NOAEL was 22.5 mg/Kg bw/day in which no effect could be observed for rats. Phosmet did not result in pathology or histhopathology of the nervous system. Due to its vapor pressure (6.5 x 10-5 Pa at 25ºC), phosmet is not regarded to be a volatile substance, therefore inhalation short term studies are not required. ",2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc07a2ae-edf7-4bec-8028-9b92bcc8c28a/documents/84d34166-a68b-47e6-86c3-ec6e6ccdd0ed_38fb4eab-18c5-4fd4-9b90-b0674e0d7184.html,,,,,, Phosmet,732-11-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc07a2ae-edf7-4bec-8028-9b92bcc8c28a/documents/84d34166-a68b-47e6-86c3-ec6e6ccdd0ed_38fb4eab-18c5-4fd4-9b90-b0674e0d7184.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,1.5 mg/kg bw/day,,dog Phosmet,732-11-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc07a2ae-edf7-4bec-8028-9b92bcc8c28a/documents/84d34166-a68b-47e6-86c3-ec6e6ccdd0ed_38fb4eab-18c5-4fd4-9b90-b0674e0d7184.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,22.5 mg/kg bw/day,,rat Phosmet,732-11-6,,2025-01-23,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc07a2ae-edf7-4bec-8028-9b92bcc8c28a/documents/84d34166-a68b-47e6-86c3-ec6e6ccdd0ed_38fb4eab-18c5-4fd4-9b90-b0674e0d7184.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,2 mg/kg bw/day,,rat Phosmet,732-11-6,"In vivo studies assessing the acute toxicity by oral, dermal and inhalation route were performed resulting in the following endpoints: Oral LD50: 230 mg/kg bw Dermal LD50: >1000 mg/kg bw Inhalation LC50: 0.152 mg/L ",2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc07a2ae-edf7-4bec-8028-9b92bcc8c28a/documents/8f6d5118-94a2-460b-89a3-6688c3785b90_38fb4eab-18c5-4fd4-9b90-b0674e0d7184.html,,,,,, Phosmet,732-11-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc07a2ae-edf7-4bec-8028-9b92bcc8c28a/documents/8f6d5118-94a2-460b-89a3-6688c3785b90_38fb4eab-18c5-4fd4-9b90-b0674e0d7184.html,,oral,LD50,230 mg/kg bw,adverse effect observed, Phosmet,732-11-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc07a2ae-edf7-4bec-8028-9b92bcc8c28a/documents/8f6d5118-94a2-460b-89a3-6688c3785b90_38fb4eab-18c5-4fd4-9b90-b0674e0d7184.html,,dermal,LD50,"> 1,000 mg/kg bw",adverse effect observed, Phosmet,732-11-6,,2025-01-23,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc07a2ae-edf7-4bec-8028-9b92bcc8c28a/documents/8f6d5118-94a2-460b-89a3-6688c3785b90_38fb4eab-18c5-4fd4-9b90-b0674e0d7184.html,,inhalation,LC50,0.152 mg/L,adverse effect observed, "Hydrocarbons, C6-7, naphtha-cracking, solvent-refined",92045-64-2,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e74363db-5034-4df5-bb1b-2d3e3f428b55/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_8ecf6d64-110a-4161-831d-cd0303581c1e.html,,,,,, "Hydrocarbons, C6-7, naphtha-cracking, solvent-refined",92045-64-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e74363db-5034-4df5-bb1b-2d3e3f428b55/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_8ecf6d64-110a-4161-831d-cd0303581c1e.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Hydrocarbons, C6-7, naphtha-cracking, solvent-refined",92045-64-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e74363db-5034-4df5-bb1b-2d3e3f428b55/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_8ecf6d64-110a-4161-831d-cd0303581c1e.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Hydrocarbons, C6-7, naphtha-cracking, solvent-refined",92045-64-2," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e74363db-5034-4df5-bb1b-2d3e3f428b55/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_8ecf6d64-110a-4161-831d-cd0303581c1e.html,,,,,, "Hydrocarbons, C6-7, naphtha-cracking, solvent-refined",92045-64-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e74363db-5034-4df5-bb1b-2d3e3f428b55/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_8ecf6d64-110a-4161-831d-cd0303581c1e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C6-7, naphtha-cracking, solvent-refined",92045-64-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e74363db-5034-4df5-bb1b-2d3e3f428b55/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_8ecf6d64-110a-4161-831d-cd0303581c1e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C6-7, naphtha-cracking, solvent-refined",92045-64-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e74363db-5034-4df5-bb1b-2d3e3f428b55/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_8ecf6d64-110a-4161-831d-cd0303581c1e.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, Furfuryl alcohol,98-00-0,"Subchronic inhalation toxicity studies with furfuryl alcohol in rats and mice and a subchronic dietary toxicity study in rats with the proximate metabolite, furfural, are available. Evidence of slight systemic toxicity was seen following oral exposure whilst following inhalation exposure the primary effect is irritation leading to tissue damage in the nasal region with a reported LOAEC of 2 ppm (8 mg/mg3). In the context of establishing a DNEL the adversity of the effect is further discussed under Section 5.8 and 5.11.2 of the CSR. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/752e196c-0ef7-4d6c-bef1-9b9f803ac13a/documents/IUC5-a401fc75-9169-4e92-8c65-7e0a4010d0b2_96c37201-451b-44cb-b37f-fb9f68d10fa5.html,,,,,, Furfuryl alcohol,98-00-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/752e196c-0ef7-4d6c-bef1-9b9f803ac13a/documents/IUC5-a401fc75-9169-4e92-8c65-7e0a4010d0b2_96c37201-451b-44cb-b37f-fb9f68d10fa5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,53 mg/kg bw/day,,rat Furfuryl alcohol,98-00-0," Considering the available data, the acute oral LD50 in the rat lies in the range of 132-275 mg/kg. The acute dermal LD50 lies in the range of 400 to 657 mg/kg.The inhalation LC50, derived from GLP studies, is > 1000 mg/m3 (1350, 1170 and 820 -2070 mg/m3). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/752e196c-0ef7-4d6c-bef1-9b9f803ac13a/documents/IUC5-7a8d6e70-4806-458a-97b3-48d7ea016694_96c37201-451b-44cb-b37f-fb9f68d10fa5.html,,,,,, Diisobutyl phthalate,84-69-5,"Information available for diisobutyl phthalate indicates that the male reproductive system is a potential target for effects following repeated oral exposure. This is supported by information available for the homologue dibutyl phthalate which, in addiiton, produced changes in liver consistent with peroxisome proliferation. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/afd5cd6e-d81b-41fb-a54b-6c5d2b3a70e4/documents/IUC5-c31de2e0-79f2-4dc0-830f-7b9bf0d6dd0e_12fdc8d7-06a1-4891-815d-7799c7e1ff63.html,,,,,, Diisobutyl phthalate,84-69-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/afd5cd6e-d81b-41fb-a54b-6c5d2b3a70e4/documents/IUC5-c31de2e0-79f2-4dc0-830f-7b9bf0d6dd0e_12fdc8d7-06a1-4891-815d-7799c7e1ff63.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,70 mg/kg bw/day,,rat Diisobutyl phthalate,84-69-5,Diisobutyl phthalate is not acutely toxic. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/afd5cd6e-d81b-41fb-a54b-6c5d2b3a70e4/documents/IUC5-cd79f2d1-1f93-4e0d-a6e3-948958f4494e_12fdc8d7-06a1-4891-815d-7799c7e1ff63.html,,,,,, Diisobutyl phthalate,84-69-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/afd5cd6e-d81b-41fb-a54b-6c5d2b3a70e4/documents/IUC5-cd79f2d1-1f93-4e0d-a6e3-948958f4494e_12fdc8d7-06a1-4891-815d-7799c7e1ff63.html,,oral,LD50,"10,000 mg/kg bw",, Diisobutyl phthalate,84-69-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/afd5cd6e-d81b-41fb-a54b-6c5d2b3a70e4/documents/IUC5-cd79f2d1-1f93-4e0d-a6e3-948958f4494e_12fdc8d7-06a1-4891-815d-7799c7e1ff63.html,,dermal,LD50,"10,000 mg/kg bw",, 4-mesyl-2-nitrotoluene,1671-49-4," NOEL (male/female) =15 mg/kg bw, rat, 28 day, gavage, OECD 407, Rattray 1999 NOEL (female) =15 mg/kg bw, no NOEL (male), rat, 90 day, gavage, OECD 408, Rattray 2005 ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b45bc2c1-d838-4394-9d50-0ea819e75091/documents/f375362c-ac64-4e8f-a64c-58ee6fa45141_a8f578b7-f88b-46d0-9fb2-190d3bade0fc.html,,,,,, 4-mesyl-2-nitrotoluene,1671-49-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b45bc2c1-d838-4394-9d50-0ea819e75091/documents/f375362c-ac64-4e8f-a64c-58ee6fa45141_a8f578b7-f88b-46d0-9fb2-190d3bade0fc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat 4-mesyl-2-nitrotoluene,1671-49-4," Oral: Male LD50=1426 (971-2479) mg/kg, Female LD50=933 (692-1259) mg/kg, rat, OECD 401, Johnson 1999Dermal: LD50>2000 mg/kg, rat, OECD 402, Lees 1999Inhalation: LC50>5400 mg/m3, rat, OECD 403, Rattray 2005 ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b45bc2c1-d838-4394-9d50-0ea819e75091/documents/bad86db3-30db-4d39-be61-2492546adf07_a8f578b7-f88b-46d0-9fb2-190d3bade0fc.html,,,,,, 4-mesyl-2-nitrotoluene,1671-49-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b45bc2c1-d838-4394-9d50-0ea819e75091/documents/bad86db3-30db-4d39-be61-2492546adf07_a8f578b7-f88b-46d0-9fb2-190d3bade0fc.html,,oral,LD50,933 mg/kg bw,adverse effect observed, (3-chloro-2-hydroxypropyl)trimethylammonium chloride,3327-22-8," The key oral study, conducted in a manner similar to (the now deleted) OECD 401 involved gavage administration of one of five doses of a 60% solution of CHPTAC to male and female rats. An LD50 value of 3.2 ml/kg bw was reported (equivalent to 3688 mg/kg bw, or 2213 mg/kg bw for pure CHPTAC). The key dermal study, conducted according to OECD 402, involved 24-h occluded contact with the test material (65% aqeous CHPTAC). An LD50 value in rats in excess of 2348 mg/kg bw was derived for the test material, that has been said to equate to 1526 mg/kg bw for 100% CHPTAC. No suitable data are available for the inhalation route. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01afec11-be7e-49c5-87d8-27fab85f1de3/documents/IUC5-e1646265-ca4b-4760-b878-07fcc2a6f06b_65b28f09-2542-476f-8c35-77271d1d227b.html,,,,,, (3-chloro-2-hydroxypropyl)trimethylammonium chloride,3327-22-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01afec11-be7e-49c5-87d8-27fab85f1de3/documents/IUC5-e1646265-ca4b-4760-b878-07fcc2a6f06b_65b28f09-2542-476f-8c35-77271d1d227b.html,,oral,LD50,"2,213 mg/kg bw",, (3-chloro-2-hydroxypropyl)trimethylammonium chloride,3327-22-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01afec11-be7e-49c5-87d8-27fab85f1de3/documents/IUC5-e1646265-ca4b-4760-b878-07fcc2a6f06b_65b28f09-2542-476f-8c35-77271d1d227b.html,,dermal,LD50,"1,526 mg/kg bw",, "Natural gas (petroleum), raw liq. mix",64741-48-6,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately 9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3 (OECD 453) ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/66d851ef-d1b3-4d41-a426-a514a19ec4e4/documents/IUC5-70ab9395-86d5-44ad-abdd-8edfe6380aeb_0081e79b-e393-4860-96b8-707e63fe296d.html,,,,,, "Natural gas (petroleum), raw liq. mix",64741-48-6,Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401)Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions)Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66d851ef-d1b3-4d41-a426-a514a19ec4e4/documents/IUC5-7b2210ac-d7ab-4596-b9f0-711bf0f0a306_0081e79b-e393-4860-96b8-707e63fe296d.html,,,,,, Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate,72490-01-8," - Oral: NOAEL = 9.7 and 10.1 mg/kg bw/day for males and females, respectively, rats, sub-chronic, 13 weeks, dietary, Bachmann 1993.  - Inhalation: NOAEL local >1050 mg/m3 and NOAEL systemic =99 mg/m3, rats, males and females, sub-acute, 4 weeks, Bernstein 1987.  - Dermal: NOAEL local >2000 mg/kg bw/day and NOAEL systemic = 200 mg/kg bw/day, rats, males and females, sub-acute, 4 weeks, Varney 1985. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e79c4315-b4cc-4c42-9daf-6f45a69b8326/documents/0c0b742e-388f-45ff-aff1-491b12b4aba2_91ebeef9-309a-4e4c-b2f0-8f2e81521657.html,,,,,, Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate,72490-01-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e79c4315-b4cc-4c42-9daf-6f45a69b8326/documents/0c0b742e-388f-45ff-aff1-491b12b4aba2_91ebeef9-309a-4e4c-b2f0-8f2e81521657.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,200 mg/kg bw/day,,rat Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate,72490-01-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e79c4315-b4cc-4c42-9daf-6f45a69b8326/documents/0c0b742e-388f-45ff-aff1-491b12b4aba2_91ebeef9-309a-4e4c-b2f0-8f2e81521657.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,99 mg/m3,,rat Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate,72490-01-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e79c4315-b4cc-4c42-9daf-6f45a69b8326/documents/0c0b742e-388f-45ff-aff1-491b12b4aba2_91ebeef9-309a-4e4c-b2f0-8f2e81521657.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,9.7 mg/kg bw/day,,rat Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate,72490-01-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e79c4315-b4cc-4c42-9daf-6f45a69b8326/documents/0c0b742e-388f-45ff-aff1-491b12b4aba2_91ebeef9-309a-4e4c-b2f0-8f2e81521657.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,050 mg/m3",no adverse effect observed,rat Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate,72490-01-8," - Oral: LD50 > 10000 mg/kg bw, males/females, rat, according to OECD TG 401, Ullmann, 1982 - Inhalation: LC50 > 4434 mg/m3, males/female, rat, according to OECD TG 403, Hartmann 1992 - Dermal: LD50 > 2000 mg/kg bw, males/females, rat, equivalent to OECD TG 402, Kynoch 1981 ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e79c4315-b4cc-4c42-9daf-6f45a69b8326/documents/8b59a04e-1d8e-405d-a311-f73e0642f436_91ebeef9-309a-4e4c-b2f0-8f2e81521657.html,,,,,, Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate,72490-01-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e79c4315-b4cc-4c42-9daf-6f45a69b8326/documents/8b59a04e-1d8e-405d-a311-f73e0642f436_91ebeef9-309a-4e4c-b2f0-8f2e81521657.html,,oral,discriminating dose,"> 10,000 mg/kg bw",no adverse effect observed, Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate,72490-01-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e79c4315-b4cc-4c42-9daf-6f45a69b8326/documents/8b59a04e-1d8e-405d-a311-f73e0642f436_91ebeef9-309a-4e4c-b2f0-8f2e81521657.html,,dermal,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, Ethyl [2-(4-phenoxyphenoxy)ethyl]carbamate,72490-01-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e79c4315-b4cc-4c42-9daf-6f45a69b8326/documents/8b59a04e-1d8e-405d-a311-f73e0642f436_91ebeef9-309a-4e4c-b2f0-8f2e81521657.html,,inhalation,discriminating conc.,"> 4,434 mg/m3",no adverse effect observed, Androstanolone,521-18-6,"No repeated dose studies are available with androstenolone. However some study results are cited in RTECS database (Jan 2010):Dermal, 28 days (Hamster): TDLo: 0.112 mg/kg/28D-I[Biological and pharmaceutical bulletin. (Pharmaceutical Society of Japan, 2-12-15, Shibuya, Shibuya-ku, Tokyo 150-0002, Japan) V.1- 1993- v. 25, p. 622, 2002 (BIPBU*)]Subcutaneous, 10 weeks (Rat): TDLo: 35 mg/kg/10W-I[European Journal of Cancer (Elsevier Science, P.O.Box 7247-7682,Philadelphia,PA 19170 -7682,USA OR Elsevier Science B.V.,P.O.Box 1270,1000 BG Amsterdam,The Netherlands) V. 1- 1965- v. 37, p. 443, 2001 (EJCAAH)]Subcutaneous, 32 days (Quail): TDLo: 320 mg/kg/32D-I[Hormones and Behavior. (Academic Press, Inc., 1 E. First St., Duluth, MN 55802) V.1- 1969- v. 49, p. 4, 2006 (HOBEAO)]Intramuscular, 33 days (domestic animal: sheep, goat): TDLo: 240 ug/kg/4D-I[Journal of Reproduction and Fertility. (Biochemical Soc. Book Depot, POB 32, Commerce Way, Colchester, Essex CO2 8HP, UK) V.1- 1960- v. 123, p. 527, 2002 (JRPFA4)]Subcutaneous, 15 days (Rat): TDLo: 75 mg/kg/15D-I[Pharmacology, Biochemistry and Behavior. (ANKHO International Inc., P.O. Box 426, Fayetteville, NY 13066) V.1- 1973- v. 89, p. 241, 2008 (PBBHAU)]Subcutaneous, 3 days (Rat): TDLo: 600 mg/kg/3D-I[Toxicology. (Elsevier Scientific Pub. Ireland, Ltd., POB 85, Limerick, Ireland) V.1- 1973- v. 170, p. 21, 2002 (TXCYAC).]Oral, 10 days (Rat): TDLo: 400 mg/kg/10D-I[Toxicology. (Elsevier Scientific Pub. Ireland, Ltd., POB 85, Limerick, Ireland) V.1- 1973- v. 195, p. 177, 2004 (TXCYAC)] ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/d344756f-c1dd-48a3-9b62-b7d6e9e5ae10/documents/IUC5-901dd792-f065-4219-81bb-ac6044082963_a7f6c455-514a-4416-ac78-d5ccfd5e88ca.html,,,,,, Androstanolone,521-18-6,"No acute toxicity studies were conducted with ZK 5145; read across approach with results of studies with androstanolone acetate (ZK 5180, CAS 1164-92-7):Oral (Rat, GLP, not audited report; OECD 423): LD50 > 2000 mg/kg[Schering AG, Report X235; 1997-08-15]Dermal (Rat, GLP, not audited report; OECD 402): LD50 > 2000 mg/kg[Schering AG, Report X296; 1998-09-24] ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d344756f-c1dd-48a3-9b62-b7d6e9e5ae10/documents/IUC5-e6e0809d-e037-4611-b720-444b746328b9_a7f6c455-514a-4416-ac78-d5ccfd5e88ca.html,,,,,, Sulfadimidine,57-68-1, NOEL oral 90 days rat = 2mg/kg/bw (Note: inhibition of thyroid peroxidase resulting in alterations in thyroid hormone concentrations and increased secretion of thyroid-stimulating hormone; mechanisms observed in rat and mice but not in monkey and it would not be expected for humans). No data regarding repeated dose toxicity for inhaltion and dermal routes. ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/02ba1616-1ca8-482e-8daa-35ddceba2cf9/documents/309ee558-df0a-4179-a1c9-03aef8293d38_2f3ed9f5-9def-4d53-bb1e-fe9e538db939.html,,,,,, Sulfadimidine,57-68-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/02ba1616-1ca8-482e-8daa-35ddceba2cf9/documents/309ee558-df0a-4179-a1c9-03aef8293d38_2f3ed9f5-9def-4d53-bb1e-fe9e538db939.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,2 mg/kg bw/day,,rat Sulfadimidine,57-68-1, LD50 oral mouse for Sulfadimidine =50000 mg/kg. No data available regarding acute inhalation toxicity and acute dermal toxicity of Sulfadimidine. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02ba1616-1ca8-482e-8daa-35ddceba2cf9/documents/25284d0e-ecf9-4147-8dfb-9d2687295e30_2f3ed9f5-9def-4d53-bb1e-fe9e538db939.html,,,,,, "Distillates (petroleum), naphtha steam cracking-derived, hydrotreated light arom.",91995-50-5,"Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene / n-hexane - when present at 10%). Adequate information is available on the constituents to characterise the repeated dermal hazards of these streams. Adequate information is available on the constituents to characterise the repeated inhalation hazards of these streams. Adequate information is available on the constituents to characterise the repeated oral hazards of these streams. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e669968-9dd3-4344-afa3-7ba303f7f42f/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_60ef695b-ae62-40fa-8a5f-53ecde254f82.html,,,,,, "Distillates (petroleum), naphtha steam cracking-derived, hydrotreated light arom.",91995-50-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e669968-9dd3-4344-afa3-7ba303f7f42f/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_60ef695b-ae62-40fa-8a5f-53ecde254f82.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), naphtha steam cracking-derived, hydrotreated light arom.",91995-50-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e669968-9dd3-4344-afa3-7ba303f7f42f/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_60ef695b-ae62-40fa-8a5f-53ecde254f82.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Distillates (petroleum), naphtha steam cracking-derived, hydrotreated light arom.",91995-50-5,"Available data for one stream within this category (CAS 68516-20-1) and data on specific constituents (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Adequate information is available to characterise the short-term hazards of these streams. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e669968-9dd3-4344-afa3-7ba303f7f42f/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_60ef695b-ae62-40fa-8a5f-53ecde254f82.html,,,,,, "Distillates (petroleum), naphtha steam cracking-derived, hydrotreated light arom.",91995-50-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e669968-9dd3-4344-afa3-7ba303f7f42f/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_60ef695b-ae62-40fa-8a5f-53ecde254f82.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), naphtha steam cracking-derived, hydrotreated light arom.",91995-50-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e669968-9dd3-4344-afa3-7ba303f7f42f/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_60ef695b-ae62-40fa-8a5f-53ecde254f82.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), naphtha steam cracking-derived, hydrotreated light arom.",91995-50-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e669968-9dd3-4344-afa3-7ba303f7f42f/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_60ef695b-ae62-40fa-8a5f-53ecde254f82.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, "Light oil (coal), coke-oven",65996-78-3,The oral LD50 of light oil is greater than 2000 mg/kg bw. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75d3e041-9712-4dcf-831c-d9bffb22f8da/documents/IUC5-9c8284be-896f-4199-ae6a-81812c92fd0f_c09af263-f907-413a-a814-700b1a7e6da6.html,,,,,, Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate],5160-02-1,"Three studies are suitable to provide information on toxicity after repeated dose administration. The subacute toxicity study in rats at dose levels up to 5 % (unknown purity) revealed formation of Heinzbodies, changes in hematology and pathological and histopathological changes in spleen and kidney. The 90d study at dose levels up to 10000 ppm which served as range finder for a cancer study confirms the findings of the 28d study. Additionally, congestion of the spleen and hemosiderosis in the liver was observed. A chronic study in mice at dose levels up to 1000 ppm revealed a NOAEL at 250 ppm. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5099836-945c-4e55-a3a0-35ff4effc1a4/documents/960416a9-0c70-423f-a3b7-97ea4e527b1a_f7f2af04-3cc5-4e16-97f3-f05e3176528d.html,,,,,, Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate],5160-02-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5099836-945c-4e55-a3a0-35ff4effc1a4/documents/960416a9-0c70-423f-a3b7-97ea4e527b1a_f7f2af04-3cc5-4e16-97f3-f05e3176528d.html,Chronic toxicity – systemic effects,oral,NOAEL,47.5 mg/kg bw/day,,mouse Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate],5160-02-1,"Four studies were performed to evaluate acute oral and inhalation toxicity of the test substance to the rat (similar to OECD 401 and 403). The test substance did not induce mortalities or abnormalities in necropsy when applied oral. In addition, single administration via the respiratory system did not treatment-related mortalities. The LD50 for oral toxicity is considered to be > 10.000 mg/kg bw, LC50 is > 5.24 mg/l air. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5099836-945c-4e55-a3a0-35ff4effc1a4/documents/e030f31b-41ee-4a23-a75e-391e74cc4ec8_f7f2af04-3cc5-4e16-97f3-f05e3176528d.html,,,,,, Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate],5160-02-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5099836-945c-4e55-a3a0-35ff4effc1a4/documents/e030f31b-41ee-4a23-a75e-391e74cc4ec8_f7f2af04-3cc5-4e16-97f3-f05e3176528d.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate],5160-02-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5099836-945c-4e55-a3a0-35ff4effc1a4/documents/e030f31b-41ee-4a23-a75e-391e74cc4ec8_f7f2af04-3cc5-4e16-97f3-f05e3176528d.html,,inhalation,discriminating conc.,5.24 mg/L,no adverse effect observed, Dichromium tris(chromate),24613-89-6,High quality (NTP) studies using oral dosing are available for sodium dichromate and potassium dichromate in the rat and mouse. Repeated dose inhalation exposure studies are available for chromium trioxide. Longer term toxicity and carcinogenicity studies are also available for compounds in this group. ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67f6a5f2-746c-490e-a30c-0d6bd7868942/documents/IUC5-0e1c1fe7-9395-4f79-b21f-52f9da7f1809_60f56209-d882-4792-96a3-8ecd85661f1d.html,,,,,, Dichromium tris(chromate),24613-89-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67f6a5f2-746c-490e-a30c-0d6bd7868942/documents/IUC5-0e1c1fe7-9395-4f79-b21f-52f9da7f1809_60f56209-d882-4792-96a3-8ecd85661f1d.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,1.7 mg/kg bw/day,, Dichromium tris(chromate),24613-89-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67f6a5f2-746c-490e-a30c-0d6bd7868942/documents/IUC5-0e1c1fe7-9395-4f79-b21f-52f9da7f1809_60f56209-d882-4792-96a3-8ecd85661f1d.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,1.81 mg/m3,, Dichromium tris(chromate),24613-89-6,"The acute oral LD50 of dichromium tris(chromate), tested as a water dilution (25% corresponding to 23.6% active ingredient) was between 50 and 300 mg active ingredient/kg bw in female rats in a recent GLP guideline study. The acute dermal LD50 of dichromium tris(chromate) 25% solution was found to be greater than 2000 mg active ingredient/kg bw in rats, in a recent GLP guideline study. No data are available for inhalation toxicity; the EU RAR (2005) reviews the data regarding the inhalation toxicity of other Cr (VI) compounds, reported LC50 values range from 99 to 217 mg/m³. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67f6a5f2-746c-490e-a30c-0d6bd7868942/documents/IUC5-54f4cc2f-eaa7-4731-a16e-1fdcfaeb01ff_60f56209-d882-4792-96a3-8ecd85661f1d.html,,,,,, Potassium cyanide,151-50-8,"The repeated dose toxicity of cyanide salts is based on effects observed from related compounds, hydrogen cyanide and acetone cyanohydrins. All category members behave similarly in generating HCN at the physiological pH of 7, and are not present as either the salt or the free CN‾ ion. As there is a significant body of data on human exposure to cyanides, this data is utilized over animal data for derivation of the DNELs The level of blood thiocyanate which is without adverse effect on the thyroid gland or other organs is established, and chronic exposure resulting in this value is calculated as an acceptable limit (see ECETOC, 2007 approach in the JACC Report No. 53). ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb1c0b86-96b2-42ac-bf68-e921f120dc17/documents/IUC5-a1975f62-caaa-4cba-8d10-4d1ef1ed3bd0_f3198b4b-45e5-48f1-8673-3ea762342cae.html,,,,,, Potassium cyanide,151-50-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb1c0b86-96b2-42ac-bf68-e921f120dc17/documents/IUC5-a1975f62-caaa-4cba-8d10-4d1ef1ed3bd0_f3198b4b-45e5-48f1-8673-3ea762342cae.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,1.35 mg/kg bw/day,, Potassium cyanide,151-50-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb1c0b86-96b2-42ac-bf68-e921f120dc17/documents/IUC5-a1975f62-caaa-4cba-8d10-4d1ef1ed3bd0_f3198b4b-45e5-48f1-8673-3ea762342cae.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,9.4 mg/m3,, Potassium cyanide,151-50-8,"Potassium cyanide is an alkali salt of the anion, cyanide, CN-, which is the solitary functional group which defines its chemical and toxicologic activity. The salt is soluble in water, resulting in the immediate formation of HCN, as the pKa value (dissociation constant) is 9.11 at 30°C. At the physiological pH of about 7, cyanide salts are distributed in the body as HCN and are not present as either the salt or the free CN‾ ion. Data are availabe for the estimation of dose descriptors and DNELs in humans, thus avoiding extrapolation from animal species. Calculations on LD50 values from animal studies provide comparable values for DNELs. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb1c0b86-96b2-42ac-bf68-e921f120dc17/documents/IUC5-33f9e278-5717-4527-a703-3eb2061673b2_f3198b4b-45e5-48f1-8673-3ea762342cae.html,,,,,, Potassium cyanide,151-50-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb1c0b86-96b2-42ac-bf68-e921f120dc17/documents/IUC5-33f9e278-5717-4527-a703-3eb2061673b2_f3198b4b-45e5-48f1-8673-3ea762342cae.html,,oral,LD50,7.49 mg/kg bw,, Potassium cyanide,151-50-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb1c0b86-96b2-42ac-bf68-e921f120dc17/documents/IUC5-33f9e278-5717-4527-a703-3eb2061673b2_f3198b4b-45e5-48f1-8673-3ea762342cae.html,,dermal,LD50,14.29 mg/kg bw,, Potassium cyanide,151-50-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb1c0b86-96b2-42ac-bf68-e921f120dc17/documents/IUC5-33f9e278-5717-4527-a703-3eb2061673b2_f3198b4b-45e5-48f1-8673-3ea762342cae.html,,inhalation,LC50,103 mg/m3,, "Hydrocarbons, C3-6, C5-rich, steam-cracked naphtha",102110-14-5,"After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and in humans. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bbcd870-2b1e-4596-8561-636f21f7354d/documents/0a65e697-ca75-4710-87c1-abe636e0b74a_96f8b977-a073-4610-9d33-e3944336ff0f.html,,,,,, "Hydrocarbons, C3-6, C5-rich, steam-cracked naphtha",102110-14-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bbcd870-2b1e-4596-8561-636f21f7354d/documents/0a65e697-ca75-4710-87c1-abe636e0b74a_96f8b977-a073-4610-9d33-e3944336ff0f.html,Chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Hydrocarbons, C3-6, C5-rich, steam-cracked naphtha",102110-14-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bbcd870-2b1e-4596-8561-636f21f7354d/documents/0a65e697-ca75-4710-87c1-abe636e0b74a_96f8b977-a073-4610-9d33-e3944336ff0f.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human (epidemiological findings) "Hydrocarbons, C3-6, C5-rich, steam-cracked naphtha",102110-14-5," Benzene does not pose an acute hazard following ingestion (oral LD50 > 2000 mg/kg), skin contact (dermal LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bbcd870-2b1e-4596-8561-636f21f7354d/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_96f8b977-a073-4610-9d33-e3944336ff0f.html,,,,,, "Hydrocarbons, C3-6, C5-rich, steam-cracked naphtha",102110-14-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bbcd870-2b1e-4596-8561-636f21f7354d/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_96f8b977-a073-4610-9d33-e3944336ff0f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C3-6, C5-rich, steam-cracked naphtha",102110-14-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bbcd870-2b1e-4596-8561-636f21f7354d/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_96f8b977-a073-4610-9d33-e3944336ff0f.html,,dermal,LD50,"8,260 mg/kg bw",no adverse effect observed, "Hydrocarbons, C3-6, C5-rich, steam-cracked naphtha",102110-14-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bbcd870-2b1e-4596-8561-636f21f7354d/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_96f8b977-a073-4610-9d33-e3944336ff0f.html,,inhalation,LC50,"43,767 mg/m3",no adverse effect observed, "Aromatic hydrocarbons, C9-12, benzene distn.",92062-36-7,Repeated Dose Oral 90d – NOAEL = 600 mg/kg bw for rats (similar to OECD TG 408)Repeated Dose Inhalation 90d – NOAEL = 1800 mg/m3 for rats (similar to OECD TG 413) ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ddcdaf79-b281-40f3-ac7e-d0853787ec99/documents/IUC5-7902d265-3321-4831-8257-1f85ff8ae9b7_b69249e1-b2fa-43a8-a637-d2dc15421583.html,,,,,, "Aromatic hydrocarbons, C9-12, benzene distn.",92062-36-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ddcdaf79-b281-40f3-ac7e-d0853787ec99/documents/IUC5-7902d265-3321-4831-8257-1f85ff8ae9b7_b69249e1-b2fa-43a8-a637-d2dc15421583.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,, "Aromatic hydrocarbons, C9-12, benzene distn.",92062-36-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ddcdaf79-b281-40f3-ac7e-d0853787ec99/documents/IUC5-7902d265-3321-4831-8257-1f85ff8ae9b7_b69249e1-b2fa-43a8-a637-d2dc15421583.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,800 mg/m3",, "Aromatic hydrocarbons, C9-12, benzene distn.",92062-36-7,Acute Toxicity-Oral LD50=3592 mg/kg in rats (OECD TG 401)Acute Toxicity-Dermal LD50>3160 mg/kg bw in rabbits (OECD TG 402)Acute Toxicity-Inhalation LC50> maximal attainable vapor concentration in rats (OECD TG 403) ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ddcdaf79-b281-40f3-ac7e-d0853787ec99/documents/IUC5-8e9a5a8b-6d8d-42b4-849b-97625d89049c_b69249e1-b2fa-43a8-a637-d2dc15421583.html,,,,,, Pseudoephedrine,90-82-4,"Acute, oral, rat (OECD TG 401, no GLP): LD50male = ca. 1000 mg/kg bw; LD50female = 464 mg/kg bwAcute, inhalation, rat (OECD TG 403, no GLP): LC50 > 2 mg/L airAcute, dermal, rat (OECD TG 402, no GLP): LD50 > 2000 mg/kg bw ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7426ce6f-6e4b-4743-8510-293ebb48f61a/documents/IUC5-ac6e1947-1f25-4a36-b6bc-5edc7388a13e_40b1d7f0-8c44-4656-9605-9e19c49f0c55.html,,,,,, "Naphtha (petroleum), solvent-refined light",64741-84-0,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56fcdb90-ba9f-4d09-a1ae-73fde7f8573d/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_68b57dae-94d3-4a82-98cc-17f963d4a461.html,,,,,, "Naphtha (petroleum), solvent-refined light",64741-84-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56fcdb90-ba9f-4d09-a1ae-73fde7f8573d/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_68b57dae-94d3-4a82-98cc-17f963d4a461.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), solvent-refined light",64741-84-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56fcdb90-ba9f-4d09-a1ae-73fde7f8573d/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_68b57dae-94d3-4a82-98cc-17f963d4a461.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), solvent-refined light",64741-84-0," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56fcdb90-ba9f-4d09-a1ae-73fde7f8573d/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_68b57dae-94d3-4a82-98cc-17f963d4a461.html,,,,,, "Naphtha (petroleum), solvent-refined light",64741-84-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56fcdb90-ba9f-4d09-a1ae-73fde7f8573d/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_68b57dae-94d3-4a82-98cc-17f963d4a461.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), solvent-refined light",64741-84-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56fcdb90-ba9f-4d09-a1ae-73fde7f8573d/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_68b57dae-94d3-4a82-98cc-17f963d4a461.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), solvent-refined light",64741-84-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56fcdb90-ba9f-4d09-a1ae-73fde7f8573d/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_68b57dae-94d3-4a82-98cc-17f963d4a461.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Distillates (petroleum), hydrotreated middle, intermediate boiling",68410-96-8," Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene - when present at 10%; n-hexane - when present at 5%). ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/452780c3-cd1d-40f7-b413-daae460939d4/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_0b707e9b-182f-4c13-ae9c-2e764f436cb1.html,,,,,, "Distillates (petroleum), hydrotreated middle, intermediate boiling",68410-96-8,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/452780c3-cd1d-40f7-b413-daae460939d4/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_0b707e9b-182f-4c13-ae9c-2e764f436cb1.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), hydrotreated middle, intermediate boiling",68410-96-8,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/452780c3-cd1d-40f7-b413-daae460939d4/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_0b707e9b-182f-4c13-ae9c-2e764f436cb1.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Distillates (petroleum), hydrotreated middle, intermediate boiling",68410-96-8," Available data for one stream within this category (CAS 68516-20-1) and data on specific components (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/452780c3-cd1d-40f7-b413-daae460939d4/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_0b707e9b-182f-4c13-ae9c-2e764f436cb1.html,,,,,, "Distillates (petroleum), hydrotreated middle, intermediate boiling",68410-96-8,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/452780c3-cd1d-40f7-b413-daae460939d4/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_0b707e9b-182f-4c13-ae9c-2e764f436cb1.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated middle, intermediate boiling",68410-96-8,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/452780c3-cd1d-40f7-b413-daae460939d4/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_0b707e9b-182f-4c13-ae9c-2e764f436cb1.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated middle, intermediate boiling",68410-96-8,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/452780c3-cd1d-40f7-b413-daae460939d4/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_0b707e9b-182f-4c13-ae9c-2e764f436cb1.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, Sodium chromate,7775-11-3,High quality (NTP) studies using oral dosing are available for sodium dichromate and potassium dichromate in the rat and mouse.  Repeated dose inhalation exposure studies are available for chromium trioxide.  Longer term toxicity and carcinogenicity studies are also availabel for compounds in this group ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6365c251-2063-45e6-bc7c-2e0628a47d52/documents/IUC5-3f8d541f-7a53-42d4-a853-e5ebfe57f595_975e2977-9993-4618-bb89-2db8f5743cce.html,,,,,, Sodium chromate,7775-11-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6365c251-2063-45e6-bc7c-2e0628a47d52/documents/IUC5-3f8d541f-7a53-42d4-a853-e5ebfe57f595_975e2977-9993-4618-bb89-2db8f5743cce.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,1.7 mg/kg bw/day,, Sodium chromate,7775-11-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6365c251-2063-45e6-bc7c-2e0628a47d52/documents/IUC5-3f8d541f-7a53-42d4-a853-e5ebfe57f595_975e2977-9993-4618-bb89-2db8f5743cce.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,1.81 mg/m3,, Sodium chromate,7775-11-3,"Proprietary (guideline & GLP-compliant) acute oral, dermal and inhalation studies are available for cthe compounds in this group.  A number ofadditional published studies have been reviewed by the UK Health & Safety Executive (HSE, 1989), the UK Institute of Occupational Health (IOH, 1997) and the EU RAR (2005).  The EU RAR also covers the studies previously reviewed in the other two reports. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6365c251-2063-45e6-bc7c-2e0628a47d52/documents/IUC5-73b63e56-1a59-4e5a-8b1d-e90cfeb63603_975e2977-9993-4618-bb89-2db8f5743cce.html,,,,,, Sodium chromate,7775-11-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6365c251-2063-45e6-bc7c-2e0628a47d52/documents/IUC5-73b63e56-1a59-4e5a-8b1d-e90cfeb63603_975e2977-9993-4618-bb89-2db8f5743cce.html,,oral,LD50,59 mg/kg bw,, Sodium chromate,7775-11-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6365c251-2063-45e6-bc7c-2e0628a47d52/documents/IUC5-73b63e56-1a59-4e5a-8b1d-e90cfeb63603_975e2977-9993-4618-bb89-2db8f5743cce.html,,dermal,LD50,"2,000 mg/kg bw",, Sodium chromate,7775-11-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6365c251-2063-45e6-bc7c-2e0628a47d52/documents/IUC5-73b63e56-1a59-4e5a-8b1d-e90cfeb63603_975e2977-9993-4618-bb89-2db8f5743cce.html,,inhalation,LC50,200 mg/m3,, Diarsenic trioxide,1327-53-3," Read across approach In the absence of substance-specific data, the repeated dose toxicity of diarsenic trioxide is assessed based on reviews and/or data for inorganic arsenic compounds. Diarsenic trioxide is readily soluble in water (17.8 g/L at 20°C). Upon dissolution in water, it reacts acidically to trivalent arsenite ions which are not subject to any relevant degree of oxidation for up to 72 hours (Klawonn, 2010). Read-across from toxicological data on inorganic arsenites to diarsenic trioxide is justified without restrictions. However, it is also known that in the human body, inorganic arsenic compounds are converted apart from As(III) also to As(V). Upon becoming systemically available, As(V) is rapidly partly converted to As(III). As(III) species are considered to be more toxic and bioactive than As(V) species. The difference in toxicological potency between As(III) and As(V) cannot be quantified exactly and may vary between routes of exposure and/or type of toxicological effects. Generally, risk assessments are conducted for ""inorganic arsenic compounds"" as a group, and do not differentiate between various species. Following a conservative approach, the toxicity of diarsenic trioxide is therefore considered to be determined by the release of soluble inorganic species (trivalent arsenites and pentavalent arsenates) which do not differ substantially in potency and may be interconverted both in the environment and in the body. Consequently, it is justified to apply read across to soluble inorganic arsenic compounds to evaluate the systemic effects, including repeated dose toxicity, of diarsenic trioxide. General remarks A large number of investigations in animals and humans on the toxic effects of inorganic arsenic compounds following repeated exposure are available, and these have been reviewed on several occasions by renowned scientific organizations. Given the overwhelming volume of data, individual Robust Study Summaries (RSS) were not developed. Instead, an overview of available investigations is presented below. When evaluating the results of the animal and human studies, it is important to remember that there are considerable differences in arsenic biotransformation between species and between individuals of a same species (see section on Toxicokinetics). Also, a number of aspects raise issues regarding the usefulness of some studies for quantifying, comparing and interpreting results, especially regarding relevance to humans and risk assessment. These include definition of the arsenic species analysed, concentrations/doses, types of cells, simulation of natural exposure for example (Cohen et al., 2013). It is generally considered that trivalent arsenic compounds are more toxic than the pentavalent forms, at least at high doses. However, the difference is difficult to quantify since a conversion between trivalent and pentavalent arsenic can occur after the substance has entered the body (ATSDR, 2007). Furthermore, exposure via the oral and inhalation routes is the most relevant for hazard and risk assessment of inorganic arsenic compounds. Dermal absorption is low (see section on Toxicokinetics), so that no significant systemic exposure is expected via this route. The following paragraphs summarise the data available on the inhalation and oral toxicity of inorganic arsenic compounds. Data on humans is presented first, followed by studies conducted in animals. Inhalation exposure Effects in humans Respiratory effects: Workers exposed to arsenic dusts in air often experience irritation to the mucous membranes of the nose and throat, which may lead to laryngitis, bronchitis or rhinitis, and very high exposures characteristic of workplace exposures in the past can cause perforation of the nasal septum. However, there have been few systematic investigations of respiratory effects in humans exposed to arsenic. None are considered to be conclusive with regard to the relationship between inhaled inorganic arsenic and respiratory disease (ATSDR, 2007). Cardiovascular effects: There is some evidence from epidemiological studies that inhaled inorganic arsenic can produce effects on the cardiovascular system, but such effects resulting from oral exposure are better characterized (ATSDR, 2007). Gastrointestinal effects: Several case studies have reported nausea, vomiting and diarrhoea in workers with acute arsenic poisoning following occupational inhalation exposure. Such effects are a common feature of oral ingestion of high doses of arsenic but exposure levels have not been reliably estimated for any of these cases (ATSDR, 2007). Neurological effects: There is evidence from epidemiological studies that inhaled inorganic arsenic can produce neurological effects. Studies of workers at the ASARCO copper smelter (USA), a power station in Slovakia and the Ronnskar smelter (Sweden) demonstrated peripheral neurological effects in workers associated with arsenic trioxide exposure (ATSDR, 2007). However, the exposure levels were difficult to quantify. Dermal effects: Dermatitis has frequently been observed in industrial workers exposed to inorganic arsenic in the air, with the highest rates occurring in workers with the greatest arsenic exposure. However, limited quantitative information is available regarding the levels that produce such dermatitis and co-exposure to other substances in the workplace by the dermal route makes a dose-response analysis difficult. The highest arsenic exposures (0.384-0.034 mg As/m3) were associated with gross pigmentation, hyperkeratinisation and multiple warts. NOAEL values for dermal irritation have not been identified (ATSDR, 2007). Other organ systems: There is no reliable evidence in humans that inhaled inorganic arsenic produces effects on other important organ systems such as liver, kidneys or the haematological, immunological and musculoskeletal systems. Effects in animals Respiratory and gastrointestinal effects: Respiratory symptoms such as rales (8 mg As/m3), laboured breathing and gasping (20 mg As/m3) were observed in a developmental study in rats with inhalation exposure to arsenic trioxide dust, with no symptoms at 2 mg As/m3. Since this sort of response is produced by a number of respirable particulate materials, it is likely that the inflammatory response was not specifically due to arsenic. Upon autopsy, some of the animals exposed to 20 mg As/m3 exhibited severe hyperaemia and plasma discharge into the intestinal lumen, whereas exposure to 8 mg As/m3 did not produce gross gastrointestinal lesions (Holson et al., 1999) (ATSDR, 2007). Immunological effects: Female mice exposed to arsenic trioxide aerosol for 3 hours showed a concentration-related decrease in pulmonary bactericidal activity, presumably as a result of injury to alveolar macrophages, and a corresponding concentration-related increase in susceptibility to introduced respiratory bacterial pathogens (Aranyi et al., 1985) (ATSDR, 2007). Other organ systems: There is no reliable evidence in animals that inhaled inorganic arsenic produces effects on other important organ systems such as liver, kidneys, skin or the haematological, immunological, cardiovascular and musculoskeletal systems (ATSDR, 2007). Oral toxicity Effects in humans There is a large body of studies in humans and animals on the toxic effects of ingested arsenic. In humans, most cases result from accidental, suicidal, homicidal or medicinal ingestion of arsenic-containing powders or solutions, or from consumption of contaminated food and drinking water. In many cases, the exact chemical form of arsenic is not known; however, it is presumed that the most likely forms are either pentavalent arsenate, trivalent arsenite or a mixture of both. Respiratory effects: Bronchitis and sequelae (bronchiectasis, bronchopneumonia) have been observed in patients and at autopsy in some chronic poisoning cases (Guha Mazumder et al. 2005; Milton and Rahman, 2002; Rosenberg, 1974; Tsai, et al. 1999; Zaldívar, 1974; Zaldívar and Guillier, 1977). Bronchopneumonia secondary to arsenic-induced bronchitis was considered to be the cause of death in one young child after several years of exposure to an average dose of 0.08 mg As/kg/day (Zaldívar and Guillier 1977). Decrements in lung function, measured as decreased FEV1, FVC and FEF25–75 have also been reported in subjects exhibiting skin lesions exposed to 0.1–0.5 mg As/L in drinking water (von Ehrenstein et al., 2005). Although in general respiratory effects have not been widely associated with repeated oral ingestion of low arsenic doses, a few studies have reported minor respiratory symptoms, such as cough, sputum, rhinorrhoea and sore throat in people with repeated oral exposure to 0.03–0.05 mg As/kg/day (Ahmad et al., 1997; Mizuta et al., 1956) (ATSDR, 2007). In a recent study, the respiratory effects of chronic low-level arsenic exposure from groundwater were evaluated in West Bengal, India, with the participants (834 non-smoking adult males) were subdivided in two groups: an arsenic-exposed group (n = 446, mean age 35.3 years) drinking arsenic-contaminated groundwater (11–50μg/L) and a control group of 388 age-matched men drinking water containing <10μg/L of arsenic. Arsenic in water samples was measured by atomic absorption spectroscopy. The prevalence of respiratory symptoms was documented via a structured, validated questionnaire. Pulmonary function test (PFT) was assessed by portable spirometer. Compared with controls, the arsenic-exposed subjects had a higher prevalence of upper and lower respiratory symptoms, dyspnoea, asthma, eye irritation and headache. Also, 20.6% of arsenic-exposed subjects had lung function deficits (predominantly restrictive and combined types) compared with 13.6% of control (p < 0.05). A positive association was observed between arsenic concentration in drinking water and the prevalence of respiratory symptoms, while a negative association existed between arsenic level and spirometric parameters. Based on the study results, the study author suggested that even low-level arsenic exposure has deleterious respiratory effects (Das et al., 2014). To evaluate the chronic effects of arsenic poisoning due to consumption of contaminated groundwater, a non-randomized, controlled, cross-sectional, observational study was carried out in the Arsenic Clinic, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, over a period of 1 year and 4 months. Seventy-three cases diagnosed clinically, consuming water containing arsenic ≥50μg/L and having arsenic levels in hair and nails >0.6μg/L, were included. Special investigations included routine parameters and organ-specific tests. Arsenic levels in drinking water, hair and nails were measured. Twenty-five non-smoking healthy controls were evaluated. Murshidabad and districts adjacent to Kolkata, West Bengal, were mostly affected. Middle-aged males were the main sufferers. Skin involvement was the most common manifestation (100%), followed by hepatomegaly [23 (31.5%)] with or without transaminitis [7 (9.58%)]/portal hypertension [9 (12.33%)]. Restrictive abnormality in spirometry [11 (15.06%)], bronchiectasis [4 (5.47%)], interstitial fibrosis [2 (2.73%)], bronchogenic carcinoma [2 (2.73%)], oromucosal plaque [7 (9.58%)], nail hypertrophy [10 (13.69%)], alopecia [8 (10.95%)], neuropathy [5 (6.84%)] and electrocardiography abnormalities [5 (6.84%)] were also observed. Based on the study results, the author concluded that mucocutaneous and nail lesions, hepatomegaly and restrictive change in spirometry were the common and significant findings in the study (Ghosh, 2013). Cardiovascular effects: A number of studies in humans indicate that arsenic ingestion may lead to serious effects on the cardiovascular system. Characteristic effects on the heart from both acute and long-term exposure include altered myocardial depolarization (prolonged QT interval, nonspecific ST segment changes) and cardiac arrhythmia (Cullen et al., 1995; Glazener et al., 1968; Goldsmith and From, 1986; Heyman et al., 1956; Little et al., 1990; Mizuta et al., 1956; Moore et al., 1994b; Mumford et al., 2007). A significant dose-related increase in the prevalence of cardiac electrophysiological abnormalities was observed in residents of Inner Mongolia, China; the incidences of QT prolongation were observed in 3.9, 11.1 and 20.6% of the residents with drinking water levels of <21, 110–300, and 430–690μg/L, respectively (Mumford et al., 2007). Long-term exposure to low to moderate arsenic levels was associated with cardiovascular disease and mortality in a population of American Indians men and women aged 47 to 74 in Arizona, Oklahoma and North/South Dakota (US) (Moon, 2013). Most dramatic is “Blackfoot Disease,” a condition that is endemic in an area of Taiwan where average drinking water levels of arsenic range from 0.17-0.80 ppm (Tseng, 1977), corresponding to doses of about 0.014–0.065 mg As/kg/day (IRIS, 2007). The disease is characterised by a progressive loss of circulation in the hands and feet, leading ultimately to necrosis and gangrene (Chen et al., 1988b; Ch’i and Blackwell, 1968; Tseng, 1977, 1989; Tseng et al., 1968, 1995, 1996). Despite other factors being suspected of playing a role in the etiology of this disease (Ko, 1986; Lu et al., 1990; Yu et al., 1984), the clear association between the occurrence of Blackfoot Disease and the intake of elevated arsenic levels indicates that arsenic is at least a contributing factor. Arsenic exposure in Taiwan has also been associated with an increased incidence of cerebrovascular and microvascular diseases (Chiou et al., 1997; Wang et al., 2002, 2003) and ischemic heart disease (Chang et al., 2004; Chen et al., 1996; Hsueh et al., 1998b; Tsai et al., 1999; Tseng et al., 2003). Hypertension, defined as a systolic blood pressure of ≥140 mm Hg in combination with a diastolic blood pressure of ≥90 mm Hg, was associated with estimated lifetime doses of approximately 0.055 mg As/kg/day (0.25 mg/L in water) in a study of people in Bangladesh (Rahman et al., 1999), whereas no significant association was found with estimated doses of 0.018 mg As/kg/day (0.75 mg/L in water). Wang et al. (2003) found an increased incidence of microvascular and macrovascular disease among subjects in Taiwan living in an arseniasis-endemic area in which the water of artesian wells had arsenic concentrations >0.35 mg/L (estimated doses of >0.03 mg As/kg/day). An additional study of Taiwanese subjects reported a significant increase in incidence of hypertension associated with concentrations of arsenic in the water >0.7 mg/L (estimated doses of >0.06 mg As/kg/day) (Chen et al., 1995). Studies in Chile indicate that ingestion of 0.6–0.8 ppm arsenic in drinking water (corresponding to doses of 0.02-0.06 mg As/kg/day, depending on age) increases the incidence of Raynaud’s disease and of cyanosis of fingers and toes (Borgoño and Greiber, 1972; Zaldívar, 1974, 1977; Zaldívar and Guillier, 1977). Autopsy of five children from this region who died of apparent arsenic toxicity showed a marked thickening of small and medium sized arteries in tissues throughout the body, especially the heart (Rosenberg, 1974). In addition, cardiac failure, arterial hypotension, myocardial necrosis, and thrombosis have been observed in children who died from chronic arsenic ingestion (Zaldívar, 1974), as well as adults chronically exposed to arsenic (Dueñas et al., 1998). Likewise, thickening and vascular occlusion of blood vessels were noted in German vintners exposed to arsenical pesticides in wine and in adults who drank arsenic-contaminated drinking water (Roth 1957; Zaldívar and Guillier, 1977). A survey of Wisconsin residents using private wells for their drinking water found that residents exposed for at least 20 years to water concentrations of >10μg As/L had increased incidences of cardiac bypass surgery, high blood pressure, and circulatory problems as compared with residents exposed to lower arsenic concentrations (Zierold et al., 2004). Similarly, Lewis et al. (1999) reported increased mortality from hypertensive heart disease in both men and women among a cohort exposed to arsenic in their drinking water in Utah, as compared with the general population of Utah. Limitations in the study included lack of evaluation of smoking as a confounder and of other dietary sources of arsenic, and the lack of a dose-response for hypertensive heart disease. Another ecological study (Engel and Smith 1994) found significant increases in deaths from arteriosclerosis, aortic aneurysm, and all other diseases of the arteries, arterioles, and capillaries among U.S. residents with arsenic drinking waters of >20μg/L; the increase in deaths from congenital anomalies of the heart and other anomalies of the circulatory system also observed in this subpopulation limits the interpretation of the findings (ATSDR, 2007). In a prospective cohort epidemiology study, the risk of young adult mortality due to high chronic exposure to arsenic through years of drinking arsenic-contaminated water was evaluated. 58,406 individuals of 4–18 years at baseline were enrolled and included using Matlab HDSS (Health and Demographic Surveillance System), an active surveillance system. Each individual’s arsenic exposure was calculated at (1) baseline As level as current exposure, (2) time-weighted lifetime exposure (average or lifetime average) and (3) cumulative arsenic exposure. Age, sex, educational attainment and SES were adjusted during the analysis. In this 13-year closed-cohort study (2003–2015), all young-adult deaths were captured through verbal autopsy using International Classification of Diseases (ICD-10) to define the causes. Girls had higher values of cumulative arsenic exposure via tube well water than boys (median: 1858.5 μg/year/L vs. 1798.8 μg/year/L) and higher mortality due to cancers, cardio-vascular disease and respiratory disease. There was a higher risk of death due to all cancers amongst young adults exposed to As > 138.7 µg/L compared to young adults exposed to As ≤ 1.1 μg/L. For cerebro-vascular disease, cardio-vascular disease and respiratory disease deaths, average arsenic in well water (>223.1 μg/L vs. ≤90.9 μg/L) and cumulative arsenic in well water (>2711.0 μg/year/L vs. ≤1013.3 μg/year/L) was linked to a 4.8 (1.8–12.8) and 5.1 (1.7–15.1) times higher risk of mortality than lower exposure. The study concluded that higher concentration of, and chronic exposure to, arsenic in drinking water, increased the mortality risk among the young adults, regardless of gender (Rahman et al., 2019). Gastrointestinal effects: Clinical signs such as gastrointestinal irritation, including nausea, vomiting, diarrhoea and abdominal pain are often observed in individuals with longer-term, low exposure to arsenic (e.g., Borgoño and Greiber, 1972; Cebrián et al., 1983; Franzblau and Lilis, 1989; Guha Mazumder et al., 1988, 1998a; Haupert et al. ,1996; Holland, 1904; Huang et al., 1985; Mizuta et al., 1956; Nagai et al., 1956; Silver and Wainman, 1952; Wagner et al., 1979; Zaldívar, 1974) but effects are usually not detectable at exposure levels below about 0.01 mg As/kg/day (Harrington et al., 1978; Valentine et al., 1985). These symptoms generally decline within a short time after exposure ceases. More severe symptoms (hematemesis, hemoperitoneum, gastrointestinal hemorrhage and necrosis) have been reported in individuals with long-term ingestion of 0.03–0.05 mg As/kg/day as a medicinal preparation (Lander et al., 1975; Morris et al., 1974) (ATSDR, 2007). Haematological effects: Anaemia and leukopenia are common effects of arsenic poisoning in humans and have been reported following intermediate (Franzblau and Lilis, 1989; Heyman et al., 1956; Nagai et al., 1956; Wagner et al., 1979) and chronic oral exposures (Chakraborti et al., 2003a; Glazener et al., 1968; Guha Mazumder et al., 1988; Hopenhayn et al., 2006; Kyle and Pease, 1965; Tay and Seah, 1975) at doses of 0.002 mg As/kg/day or more. These may be due to direct cytotoxic or haemolytic effect on blood cells (Armstrong et al., 1984; Fincher and Koerker, 1987; Goldsmith and From, 1986; Kyle and Pease, 1965; Lerman et al., 1980) and a suppression of erythropoiesis (Kyle and Pease, 1965; Lerman et al., 1980). However, haematological effects are not observed in all cases of arsenic exposure (EPA, 1981b; Harrington et al., 1978; Huang et al., 1985; Silver and Wainman, 1952) (ATSDR, 2007). Hepatic effects: A number of studies in humans exposed to inorganic arsenic by the oral route have noted signs or symptoms of hepatic injury. Clinical examination often revealed that the liver was swollen and tender (Chakraborty and Saha, 1987; Franklin et al., 1950; Guha Mazumder et al., 1988, 1998a; Liu et al., 2002; Mizuta et al., 1956; Silver and Wainman, 1952; Wade and Frazer, 1953; Zaldívar, 1974) and analysis of blood sometimes showed elevated levels of hepatic enzymes (Armstrong et al., 1984; Franzblau and Lilis, 1989; Guha Mazumder, 2005; Hernández-Zavala et al., 1998). These effects are most often observed after repeated exposure to doses of 0.01–0.1 mg As/kg/day (Chakraborty and Saha, 1987; Franklin et al., 1950; Franzblau and Lilis ,1989; Guha Mazumder et al., 1988; Mizuta et al., 1956; Silver and Wainman, 1952; Wade and Frazer, 1953), although doses as low as 0.006 mg As/kg/day have been reported to have an effect following chronic exposure (Hernández-Zavala et al., 1998). Histological examination of the livers of persons chronically exposed to arsenic revealed a consistent finding of portal tract fibrosis (Guha Mazumder, 2005; Guha Mazumder et al., 1988; Morris et al., 1974; Piontek et al., 1989; Szuler et al., 1979), leading in some cases to portal hypertension and bleeding from oesophageal varices (Szuler et al., 1979). Cirrhosis has also been reported at increased frequency in arsenic-exposed individuals (Tsai et al., 1999). Several researchers consider that these hepatic effects are secondary to damage to hepatic blood vessel damage (Morris et al., 1974; Rosenberg, 1974), but this is not directly established (ATSDR, 2007). Dermal effects: One of the most common, characteristic, effects of arsenic ingestion is a pattern of skin changes that include generalized hyperkeratosis and formation of hyperkeratotic warts or corns on the palms and soles, along with areas of hyperpigmentation interspersed with small areas of hypopigmentation on the face, neck and back. These and other dermal effects have been noted in a large majority of human studies involving repeated oral exposure (e.g., Ahmad et al., 1997, 1999b; Ahsan et al., 2000; Bickley and Papa, 1989; Borgoño and Greiber, 1972; Borgoño et al., 1980; Cebrián et al., 1983; Chakraborti et al., 2003a, 2003b; Chakraborty and Saha, 1987; Foyet al., 1992; Franklin et al., 1950; Franzblau and Lilis, 1989; Guha Mazumder et al., 1988, 1998a, 1998b, 1998c; Guo et al., 2001a; Haupert et al., 1996; Huang et al., 1985; Lander et al., 1975; Liu et al., 2002; Lüchtrath, 1983; Milton et al., 2004; Mizuta et al., 1956; Morris et al., 1974; Nagai et al., 1956; Piontek et al., 1989; Rosenberg, 1974; Saha and Poddar, 1986; Silver and Wainman, 1952; Szuler et al., 1979; Tay and Seah, 1975; Tseng et al., 1968; Wade and Frazer, 1953; Wagner et al., 1979; Wong et al., 1998a, 1998b; Zaldívar, 1974, 1977). In cases of low-level chronic exposure (usually from water), these skin lesions appear to be the most sensitive indication of exposure, so this endpoint is considered to be the most appropriate basis for establishing a chronic oral MRL. This is supported by the finding that other effects (hepatic injury, vascular disease and neurological changes) also appear to have similar thresholds. Numerous studies in humans have reported dermal effects at chronic dose levels generally ranging from about 0.01-0.1 mg As/kg/day (Ahmad et al., 1997; Bickley and Papa, 1989; Borgoño and Greiber, 1972; Borgoño et al., 1980; Cebrián et al., 1983; Chakraborty and Saha, 1987; Foy et al., 1992; Franklin et al., 1950; Guha Mazumder et al., 1988; Huang et al., 1985; Lüchtrath, 1983; Piontek et al., 1989; Silver and Wainman, 1952; Tseng et al., 1968; Zaldívar, 1974, 1977). However, in a study with detailed exposure assessment, all confirmed cases of skin lesions occurred following ingested water containing >100μg/L arsenic (approximately 0.0037 mg As/kg/day) and the lowest known peak arsenic concentration ingested by a case was 0.115μg/L (approximately 0.0043 mg As/kg/day) (Haque et al., 2003). Another large study reported increased incidence of skin lesions associated with estimated doses of 0.0012 mg As/kg/day (0.023 mg As/L drinking water) (Ahsan et al., 2006). Several epidemiological studies of moderately sized populations (20–200 people) exposed to arsenic through drinking water detected no dermal or other effects at average chronic doses of 0.0004–0.01 mg As/kg/day (Cebrián et al., 1983; EPA, 1981b; Guha Mazumder et al., 1988; Harrington et al., 1978; Valentine et al., 1985) and one very large study detected no effects at an average total daily intake (from water plus food) of 0.0008 mg As/kg/day (Tseng et al., 1968). Neurological effects: A large number of epidemiological studies and case reports indicate that ingestion of inorganic arsenic can cause injury to the nervous system. Repeated exposure to low levels (0.03–0.1 mg As/kg/day) is typically characterised by a symmetrical peripheral neuropathy (Chakraborti et al., 2003a, 2003b; Foy et al., 1992; Franzblau and Lilis, 1989; Guha Mazumder et al., 1988; Hindmarsh et al., 1977; Huang et al., 1985; Lewis et al., 1999; Mizuta et al., 1956; Muzi et al., 2001; Silver and Wainman, 1952; Szuler et al., 1979; Wagner et al., 1979). Neurological effects were not generally found in populations chronically exposed to doses of 0.006 mg As/kg/day or less (EPA 1981b; Harrington et al., 1978; Hindmarsh et al., 1977). There is emerging evidence suggesting that exposure to arsenic may be associated with intellectual deficits in children. For example, Wasserman et al. (2004) conducted a cross-sectional evaluation of intellectual function in 201 children, 10 years of age, whose parents were part of a larger cohort in Bangladesh. After adjustment for confounding factors, a dose-related inverse effect of arsenic exposure was seen on both performance and Full-Scale subset scores. For both endpoints, exposure to ≥50μg/L resulted in statistically significant differences (p<0.05) relative to the lowest exposure group (<5.5μg/L). A study of 351 children age 5–15 years from West Bengal, India, found significant associations between urinary arsenic concentrations and reductions in scores of tests of vocabulary, object assembly and picture completion. The magnitude of the reductions varied between 12 and 21% (von Ehrenstein et al., 2007). In this cohort, the average lifetime peak arsenic concentration in well water was 0.147 mg/L. However, no clear pattern was found for increasing categories of peak arsenic water concentrations since birth and children’s scores in the various neurobehavioral tests conducted. Furthermore, using peak arsenic as a continuous variable in the regression models also did not support an adverse effect on the tests results (ATSDR, 2007). Renal effects: Most case studies of chronic arsenic toxicity do not report clinical signs of significant renal injury, even when other systems are severely impaired (e.g., Cullen et al. 1995; Franzblau and Lilis, 1989; Jenkins, 1966; Kersjes et al., 1987; Mizuta et al., 1956; Silver and Wainman, 1952) (ATSDR, 2007). Other organ systems: No reliable studies of musculoskeletal or immunological effects in humans after oral exposure to inorganic arsenicals have been reported (ATSDR, 2007). Effects in animals Respiratory effects: There are only few data regarding respiratory effects in animals following oral exposure to inorganic arsenic. An infant Rhesus monkey that died after 7 days of oral exposure to a complex arsenate salt at a dose of 3 mg As/kg/day exhibited bronchopneumonia with extensive pulmonary haemorrhage, oedema and necrosis (Heywood and Sortwell, 1979). Two other monkeys in this treatment group survived a 1-year exposure period and had no gross or microscopic pulmonary lesions at sacrifice. Increased relative lung weights were seen in rats exposed to 6.66 mg As/kg/day as sodium arsenite 5 days/week for 12 weeks (Schulz et al., 2002). Chronic oral studies in dogs and rats treated with arsenate or arsenite failed to find respiratory lesions (Byron et al., 1967; Kroes et al., 1974; Schroeder et al., 1968) (ATSDR, 2007). Cardiovascular effects: Alterations in vascular reactivity was noted in rats given repeated oral doses of arsenic trioxide (11 mg As/kg/day) for several weeks (Bekemeier and Hirschelmann, 1989), although no histological effects could be detected in the hearts of rats or dogs exposed to up to 30 mg As/kg/day as arsenate or arsenite for 2 years (Byron et al., 1967; Kroes et al., 1974; Schroeder et al., 1968). Guinea pigs exposed to arsenic trioxide for 1 day (0, 7.6, 22.7, or 37.9 mg As/kg) or 8 days (0 or 3.8 mg As/kg/day) showed prolongation of the cardiac QT interval and action potential duration (Chiang et al., 2002) (ATSDR, 2007). Gastrointestinal effects: Clinical signs of gastrointestinal irritation were observed in monkeys and rats given repeated oral doses of arsenic (6 and 11 mg As/kg/day, respectively) for 2 weeks (Bekemeier and Hirschelmann, 1989; Heywood and Sortwell, 1979). Hemorrhagic gastrointestinal lesions have also been reported in animal studies. A monkey that died after repeated oral treatment with 6 mg As/kg/day for approximately 1 month was found to have acute inflammation and hemorrhage of the small intestine upon necropsy (Heywood and Sortwell, 1979). This lesion was not found in other monkeys that died in this study, or in the survivors. Two pregnant mice that died after repeated gavage treatment with 24 mg As/kg/day as arsenic acid had haemorrhagic lesions in the stomach (Nemec et al., 1998). Gross gastrointestinal lesions (stomach adhesions, eroded luminal epithelium in the stomach) were seen frequently in rats treated by gavage with 8 mg As/kg/day as arsenic trioxide starting before mating and continuing through the end of gestation (Holson et al., 2000). The lesions were not found in rats treated with 4 mg As/kg/day in this study. No histological evidence of gastrointestinal injury was detected in rats exposed to arsenate or arsenite in the feed for 2 years at doses up to 30 mg As/kg/day, but dogs fed a diet containing 2.4 mg As/kg/day as arsenite for 2 years had some bleeding in the gut (Byron et al., 1967; Kroes et al. 1974) (ATSDR, 2007). Haematological effects: Long-term studies found mild anaemia in dogs fed arsenite or arsenate for 2 years at 2.4 mg As/kg/day, but no haematological effect in dogs fed 1 mg As/kg/day for 2 years or 1.9 mg As/kg/day for 26 weeks (Byron et al., 1967; Neiger and Osweiler, 1989). Chronic rat studies found little or no evidence of anaemia at doses up to 30 mg As/kg/day, even with co-exposure to lead (Byron et al., 1967; Kroes et al., 1974). No haematological effects were found in monkeys exposed to arsenic doses of 3–6 mg As/kg/day for 1 year (Heywood and Sortwell, 1979).Exposure of rats to ≥5 ppm of arsenic (0.30 mg As/kg/day as sodium arsenite) in the drinking water for 4 weeks resulted in increased platelet aggregation, while 10 or 25 ppm (0.60 or 1.5 mg As/kg/day) was associated with increased P-selectin-positive cells and decreased occlusion time (Lee et al. 2002), representing a change in platelet function. Similarly, exposure of rats or guinea pigs to 10 or 25 ppm of arsenic as arsenite (approximate doses of 0, 0.92, or 2.3 mg As/kg/day for rats and 0, 0.69, or 1.7 mg As/kg/day for guinea pigs) in the drinking water for 16 weeks (Kannan et al. 2001) resulted in decreases in erythrocyte and leukocyte numbers (rats and guinea pigs), increased blood mean corpuscular volume and corpuscular haemoglobin mass (guinea pigs only), and decreased mean corpuscular haemoglobin concentration (rats only) (ATSDR, 2007). Hepatic effects: Studies in dogs or mice have not detected clinically significant hepatic injury following exposure to either arsenite or arsenate (Byron et al., 1967; Fowler and Woods, 1979; Kerkvliet et al., 1980; Neiger and Osweiler, 1989; Schroeder and Balassa, 1967), although enlargement of the common bile duct was noted in rats fed either arsenate or arsenite in the diet for 2 years (Byron et al., 1967; Kroes et al., 1974) and lipid vacuolation and fibrosis were seen in the livers of rats exposed to 12 mg As/kg/day as arsenate in the drinking water for 6 weeks (Fowler et al., 1977). Similarly, fatty changes and inflammatory cell infiltration were seen in the livers of both normal and metallothionein-null mice exposed to 5.6 mg arsenic/kg/day in the drinking water for 48 weeks (Liu et al., 2000). An increase in indices of peroxidation was reported in rats dosed with approximately 0.02 mg As/kg/day for 60 days from drinking water containing 2.5 mg sodium arsenite/L (Bashir et al., 2006); absolute liver weight was also increased at this dose level. Exposure of guinea pigs to 0.69 or 1.7 mg As/kg/day in the drinking water for 16 weeks, but not in rats exposed to 0.92 or 2.3 mg As/kg/day, resulted in increases in delta-aminolaevulinic acid synthetase (ALAS) levels (Kannan et al., 2001). Exposure of BALB/C mice to 0.7 mg arsenic/kg/day in the drinking water for 15 months resulted in increased liver weights, changes in liver enzymes (glutathione S-transferase, glutathione reductase, catalase, glucose-6-phosphate dehydrogenase, glutathione peroxidase), fatty liver, and fibrosis (Santra et al., 2000) (ATSDR, 2007). Dermal effects: Dermal lesions similar to those observed in humans have not been noted in oral exposure studies in monkeys (Heywood and Sortwell, 1979), dogs (Byron et al., 1967) or rodents (Schroeder et al., 1968) (ATSDR, 2007). Neurological effects: Neurological effects have been observed in animal studies. Rodriguez et al. (2001) evaluated neurobehavioral changes in male Sprague-Dawley rats exposed to 0, 5, 10 or 20 mg As/kg/day as sodium arsenite by gavage for 2 or 4 weeks. Significant effects were seen in spontaneous locomotor activity and the food pellet manipulation test in the high-dose animals, while no effects were seen in the low- or mid-dose rats. Decreased performance in open field tests were also seen in rats exposed to 26.6 mg As/kg/day, but not to 13.3 mg/kg/day or less, as sodium arsenite for 4 weeks (Schulz et al., 2002). Curiously, the behavioural changes were no longer present at 8 and 12 weeks of exposure, which may suggest an adaptive response. Heywood and Sortwell (1979) reported salivation and uncontrolled head shaking in two monkeys given several doses of 6 mg As/kg/day as arsenate, while no such effects were noted in monkeys given 3 mg As/kg/day for 2 weeks. Nemec et al. (1998) observed ataxia and prostration in pregnant female rabbits treated with 1.5 mg As/kg/day repeatedly during gestation, but not in rabbits treated with 0.4 mg As/kg/day (ATSDR, 2007). In a subacute oral toxicity study in rats, arsenic and fluoride exposure on motor behavior and general toxicity were modelled in young adult male rats which received sodium (meta) arsenite (10 mg/kg bw), sodium fluoride (5 mg/kg bw), and their combination by gavage, once daily, 5 days a week for 6 weeks. After 6 weeks, 6 animals per group were dissected, while the other 6 were kept for 6 more weeks untreated. Body weight, together with food and water consumption, was measured daily. Arsenic, alone or along with fluoride, caused significant decrease in rearing, and increase in immobility and local activity in the open field in the 3rd and 6th week. By the 12th week, these changes mostly diminished. Weight gain, and food and water consumption were significantly reduced by arsenic but normalized post treatment. Fluoride had no own effect and mostly no influence on effects of arsenic. Massive deposition of arsenic in the rats’ blood, cerebral cortex, and liver by the 6th week, and partial elimination by the 12th week, was seen. The study author concluded that the results underline the risk of neuro-functional damage by arsenic and called for further investigations (Sárközi et al., 2015). Reproductive organ effects: A study was conducted to determine the sub-chronic exposure effect of sodium arsenite on reproductive organs of female Wistar rats. Mature female rats were divided into 4 groups of 12 animals each. Group I received distilled water, whereas the other 3 groups received sodium arsenite at 10, 30, and 50 µg/L doses for 60 days through drinking water. Half of the animals from each group were dissected after 30 days and the remaining after 60 days. A disruption in estrous cycle was observed with prolonged diestrous and metestrous phases. A significant increase in ovarian surface epithelium and follicular atresia was observed in treated rats (p ≤ 0.05). A significant decrease (p ≤ 0.05) in the uterine myometrium was observed. A significant increase (p ≤ 0.05) in the levels of lipid peroxidation along with decrease in the activities of antioxidant enzymes was observed. The study author based on the results concluded that the sub-chronic exposure to sodium arsenite causes degenerative changes in reproductive organs and induces oxidative stress in female rats (Mehta et al., 2016). In a subacute toxicity study in mice, the effects of As2O3 on sperm and testicular morphology, androgen receptor (AR) immunoreactivity in testes and epididymis, in addition to evaluation of fertility parameters in adult male mice were determined. 30 adult Swiss mice were divided into three experimental groups: control; received distilled water (vehicle) while treated received 0.3 or 3 mg/kg/day As2O3 subcutaneously, for 5 days per week, followed by 2 days of interruption, for 5 weeks. Results showed that As2O3 (1) decreased spermatozoa number, (2) produced seminiferous epithelium degeneration and exfoliation of germ cells tubule lumen (3) altered nucleus/cytoplasm proportion of Leydig cells and (4) reduced AR immunoreactivity in both Leydig and epithelial epididymal cells. Further, fetal viability tests demonstrated an increase in post-implantation loss in females that were mated with As2O3-treated males. Data indicate that As2O3 exposure altered the spermatogenic process and subsequently fetal viability (Da Silva et al., 2017). Other organ systems: No reliable studies of musculoskeletal or immunological effects in humans after oral exposure to inorganic arsenicals have been reported (ATSDR, 2007). Studies in animals also indicate that the kidney is not a major target organ for inorganic arsenic (Byron et al., 1967; Schroeder and Balassa, 1967; Woods and Southern, 1989) (ATSDR, 2007). Mode of action The mechanism by which inorganic arsenic produces its effects in various organs and systems is not entirely elucidated. There is growing evidence for a mode of action involving the formation of reactive trivalent metabolites interacting with critical cell sulfhydryl groups, leading to cytotoxicity and regenerative cell proliferation. The cytotoxicity results in non-cancer toxicities and the cell proliferation enhances the development of epithelial cancers (see section on Carcinogenicity). In other tissues such as vascular endothelium, different toxicities develop, not cancer (Cohen et al., 2013). References not cited in ATSDR (2007) Cohen SM et al. (2013). Evaluation of the carcinogenicity of inorganic arsenic. Crit. Rev. Toxicol. 43(9):711-752. Ghosh A (2013). Evaluation of chronic arsenic poisoning due to consumption of contaminated ground water in West Bengal, India. Int. J. Prev. Med. 4(8):976-9. Das D et al. (2014). Chronic low-level arsenic exposure reduces lung function in male population without skin lesions. Int. J. Public Health 59(4):655-63. Sárközi K et al. (2015). Behavioral and general effects of subacute oral arsenic exposure in rats with and without fluoride. Int. J. Environ. Health. Res. 25(4):418-31. Mehta M and Hundal SS (2016). Effect of sodium arsenite on reproductive organs of female Wistar rats. Arch. Environ. Occup. Health. 71(1):16-25. Moon KA et al. (2013). Association between exposure to low to moderate arsenic levels and incident cardiovascular disease. Annals Int. Med. http://annals.org. Da Silva RF et al.(2017). Arsenic trioxide exposure impairs testicular morphology in adult male mice and consequent fetus viability. J. Toxicol. Environ. Health A. 80 (19-21):1166-1179. Rahman M et al. (2019). Arsenic exposure and young adult’s mortality risk: a 13-year follow-up study in Matlab, Bangladesh. Environ. Int. 123:358-367. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7832ab5-2b40-4679-b72d-07e4ec352683/documents/0a191b56-1e49-4de4-a240-2ed998aba5dd_e84dd981-6098-4d22-91ef-323c07a8368b.html,,,,,, Diarsenic trioxide,1327-53-3," Read across approach Diarsenic trioxide is readily soluble in water (17.8 g/L at 20°C). Upon dissolution in water, it reacts acidically to trivalent arsenite ions which are not subject to any relevant degree of oxidation for up to 72 hours (Klawonn, 2010). Read-across from toxicological data on inorganic arsenites to diarsenic trioxide is justified without restrictions. However, it is also known that in the human body, inorganic arsenic compounds are converted apart from As(III) also to As(V). Upon becoming systemically available, As(V) is rapidly partly converted to As(III). As(III) species are considered to be more toxic and bioactive than As(V) species. The difference in toxicological potency between As(III) and As(V) cannot be quantified exactly and may vary between routes of exposure and/or type of toxicological effects. Generally, risk assessments are conducted for ""inorganic arsenic compounds"" as a group, and do not differentiate between various species. Following a conservative approach, the toxicity of diarsenic trioxide is therefore considered to be determined by the release of soluble inorganic species (trivalent arsenites and pentavalent arsenates) which do not differ substantially in potency and may be interconverted both in the environment and in the body. Consequently, it is justified to apply read across to soluble inorganic arsenic compounds to evaluate the systemic effects, including acute toxicity, of diarsenic trioxide. The acute toxicity of arsenic compounds has been studied to great extent in animal studies and there are also many case reports of acute effects in humans. The focus of such investigations has been on oral exposure. Because of the enormous amount of data, reference is made to available reviews, such as the ""Toxicological Profile for Arsenic (ATSDR, 2007), or to peer-reviewed factual databases, such as the Hazardous Substance Databank (HSDB) and the Registry of Toxic Effects of Chemical Substances (RTECS). Oral For diarsenic trioxide, reported oral LD50s in animals are in the range from ca. 10-214 mg/kg, which is in agreement with the existing harmonized classification as Acute Tox 2 - H300 according to Regulation (EC) No 1272/2008. Human case reports of accidental or deliberate poisoning support the conclusion that diarsenic trioxide is acutely toxic via the oral route. Inhalation Acute inhalation exposure of humans to diarsenic trioxide usually does not take place to a significant extent and does not usually lead to lethality, but irritation of skin and mucous membranes has been observed (in agreement with the existing harmonised classification as Skin Corr. 1B). After evaluation of all available data (existing reviews, literature searches in factual and bibliographic databases) a reliable standard toxicity descriptor value, such as a LC50(4h), cannot be established for diarsenic trioxide. A standard acute inhalation toxicity study (e.g. OECD TG 403 or comparable guideline) is not available. Some animal studies are available which used intratracheal injection as the route of exposure, but are not focused on lethality as an endpoint, but rather on local lung effects, lung clearance issues or carcinogenicity. Due to the well-known toxicological profile of arsenic compounds, including diarsenic trioxide, and specifically because of the carcinogenic potential, strict measures are already in place to exclude or minimise as far as possible any exposure of humans to such compounds. Dermal Adverse effects from dermal exposure to inorganic or organic arsenicals have not been extensively investigated. No studies were located regarding death in humans after dermal exposure to inorganic arsenicals. In rats, no deaths resulted from dermal exposure to arsenate or arsenite at doses up to 1000 mg As/kg (e.g. Gaines, 1960). These data indicate that dermal exposure to inorganic arsenic compounds is very unlikely to result in lethality. According to reliable reviews, the dermal absorption of inorganic arsenic compounds is considered to be low (<10%), rendering this route of exposure to be of limited relevance. The chemical nature of arsenic metal, together with its poor solubility, renders its potential for uptake through skin low. This is also the case for any expected transformation/dissolution products, i.e. dissolved arsenic in ionic form. Uptake of arsenic through the skin has been determined to occur at rates below 2%, when applied in dissolved form as radiolabelled arsenic acid to human skin in vitro (Wester et al., 1993).With regards to this low dermal absorption, we can consider this route of exposure to be of limited relevance. Due to the well-known toxicological profile of arsenic compounds, including diarsenic trioxide, and specifically because of the carcinogenic potential, strict measures are already in place to exclude or minimise as far as possible any exposure of humans to such compounds. Therefore, and for animal welfare reasons, it is not justified to conduct further toxicological studies in experimental animals. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7832ab5-2b40-4679-b72d-07e4ec352683/documents/IUC5-e0bcb33e-4d23-46e2-ae6e-4a71bbb0bf47_e84dd981-6098-4d22-91ef-323c07a8368b.html,,,,,, Diarsenic trioxide,1327-53-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7832ab5-2b40-4679-b72d-07e4ec352683/documents/IUC5-e0bcb33e-4d23-46e2-ae6e-4a71bbb0bf47_e84dd981-6098-4d22-91ef-323c07a8368b.html,,oral,LD50,10 mg/kg bw,adverse effect observed, "Distillates (petroleum), light distillate hydrotreating process, low-boiling",68410-97-9,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/13bcf053-7675-4147-b190-4ae2cee437cb/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_33d5b69c-bc72-451d-9d09-0fd275a6eaa3.html,,,,,, "Distillates (petroleum), light distillate hydrotreating process, low-boiling",68410-97-9,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/13bcf053-7675-4147-b190-4ae2cee437cb/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_33d5b69c-bc72-451d-9d09-0fd275a6eaa3.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Distillates (petroleum), light distillate hydrotreating process, low-boiling",68410-97-9,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/13bcf053-7675-4147-b190-4ae2cee437cb/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_33d5b69c-bc72-451d-9d09-0fd275a6eaa3.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Distillates (petroleum), light distillate hydrotreating process, low-boiling",68410-97-9,"The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401)Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions)Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13bcf053-7675-4147-b190-4ae2cee437cb/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_33d5b69c-bc72-451d-9d09-0fd275a6eaa3.html,,,,,, "Distillates (petroleum), light distillate hydrotreating process, low-boiling",68410-97-9,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13bcf053-7675-4147-b190-4ae2cee437cb/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_33d5b69c-bc72-451d-9d09-0fd275a6eaa3.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light distillate hydrotreating process, low-boiling",68410-97-9,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13bcf053-7675-4147-b190-4ae2cee437cb/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_33d5b69c-bc72-451d-9d09-0fd275a6eaa3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light distillate hydrotreating process, low-boiling",68410-97-9,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13bcf053-7675-4147-b190-4ae2cee437cb/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_33d5b69c-bc72-451d-9d09-0fd275a6eaa3.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Gasoline, pyrolysis, hydrogenated",94114-03-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Adequate information is available on the constituents to characterise the repeated dermal hazards of these streams. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Adequate information is available on the constituents to characterise the repeated inhalation hazards of these streams. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Adequate information is available on the constituents to characterise the repeated oral hazards of these streams. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/844f1d95-7b3c-4c19-a2ac-66446274766e/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_1400c46b-8b6c-4ca2-8b27-455cc3cb236c.html,,,,,, "Gasoline, pyrolysis, hydrogenated",94114-03-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/844f1d95-7b3c-4c19-a2ac-66446274766e/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_1400c46b-8b6c-4ca2-8b27-455cc3cb236c.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Gasoline, pyrolysis, hydrogenated",94114-03-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/844f1d95-7b3c-4c19-a2ac-66446274766e/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_1400c46b-8b6c-4ca2-8b27-455cc3cb236c.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Gasoline, pyrolysis, hydrogenated",94114-03-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Adequate information is available to characterise the short-term hazards of these streams. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Adequate information is available to characterise the short-term hazards of these streams. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Adequate information is available to characterise the short-term hazards of these streams. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/844f1d95-7b3c-4c19-a2ac-66446274766e/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_1400c46b-8b6c-4ca2-8b27-455cc3cb236c.html,,,,,, "Gasoline, pyrolysis, hydrogenated",94114-03-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/844f1d95-7b3c-4c19-a2ac-66446274766e/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_1400c46b-8b6c-4ca2-8b27-455cc3cb236c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Gasoline, pyrolysis, hydrogenated",94114-03-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/844f1d95-7b3c-4c19-a2ac-66446274766e/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_1400c46b-8b6c-4ca2-8b27-455cc3cb236c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gasoline, pyrolysis, hydrogenated",94114-03-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/844f1d95-7b3c-4c19-a2ac-66446274766e/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_1400c46b-8b6c-4ca2-8b27-455cc3cb236c.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, Fluocortolone,152-97-6,"In systemic tolerance studies involving repeated administration of both subcutaneous and oral doses in rats and dogs for 4 to 80 weeks, typical glucocorticoid effects were observed: degeneration of lymphatic tissue, suppression of the adrenal cortex, impairment of the hematogenic tissue (bone marrow) (Dres et al., 1975; Günzel et al., 1976; Staben, 1979; Woodard et al., 1966, 1967, 1969). ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b67569fd-3176-46bd-9558-ab9690608e2d/documents/IUC5-ef527364-4ea3-4644-b639-d5dea8fa573c_004e50a3-4878-49bb-8f82-dd0135760a0b.html,,,,,, Fluocortolone,152-97-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b67569fd-3176-46bd-9558-ab9690608e2d/documents/IUC5-ef527364-4ea3-4644-b639-d5dea8fa573c_004e50a3-4878-49bb-8f82-dd0135760a0b.html,Chronic toxicity – systemic effects,oral,LOAEL,0.1 mg/kg bw/day,,rat Fluocortolone,152-97-6,"Study report: Acute oral toxicity in Wistar rats (OECD 401); results; LD50 = 245 mg/kg bw [Günzel, 1965]Study reports: Acute oral toxicity in NRMI mice, male and female (similar to OECD 401); results:LD50 males: 1500 mg/kg bw, LD50 females: 1300mg/kg bw [Günzel, 1969]Study reports: Acute oral toxicity in beagle dogs, male and female (similar to OECD 401); results: In both studies the LD50 value could not be determined because no adverase erffects occurred, Highest dose tested was 100 mg/kg bw in the first study and 200 mg/kg bw in the second study. [Günzel, 1965 and 1971] Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is of sufficient quality (Klimisch score = 2) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b67569fd-3176-46bd-9558-ab9690608e2d/documents/IUC5-03184e89-886d-4465-8bec-ca6bf881884d_004e50a3-4878-49bb-8f82-dd0135760a0b.html,,,,,, Fluocortolone,152-97-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b67569fd-3176-46bd-9558-ab9690608e2d/documents/IUC5-03184e89-886d-4465-8bec-ca6bf881884d_004e50a3-4878-49bb-8f82-dd0135760a0b.html,,oral,LD50,245 mg/kg bw,adverse effect observed, Selenium,7782-49-2," Background   A read-across category-approach is used for the assessment of the toxicological properties of selenium and selenium compounds. The following Se-substance are included in the category: Se-metal (massive, powder) Disodium selenate Disodium selenite Selenium dioxide / selenious acid Zinc selenite Barium selenite A detailed rationale for the read-across hypothesis has been outlined in the read-across report that was generated according to the principles laid out in the Read-Across Assessment Framework (RAAF). In summary, the physico-chemical behavior of elemental selenium (once it has formed an ion-from its metal state), disodium selenite, disodium selenate and selenium dioxide/selenious acid is the same with regard to their metabolic fate. All selenium compounds (organic and inorganic, including elemental selenium), do share the very same metabolic fate in that after their resorption, reduction to the selenide moiety [Se2-], which is the single common precursor for its further metabolic conversion, takes place. Therefore, there seems to be good evidence that different selenium moieties will behave very similar also for their ability to form reactive species which may play a decisive role in the generation of cytotoxicity followed likewise by unspecific and secondary clastogenicity and read-across can be made from the available data for disodium selenite. It is concluded that additional testing for each individual member of the proposed Se-category is not necessary and scientifically not meaningful. In the case of inorganic salts like barium selenite and zinc selenite, uptake is always associated with a dissolution of the substance, i.e. dissociation into the metal cation (Zn2+, Ba2+) and the selenite anion (SeO32-). It can safely be assumed that the selenium/selenite moiety of barium/zinc selenite is generally of higher toxicological relevance than the zinc/barium cations. Therefore, the subsequent assessment of the toxicity of barium/zinc selenite focuses on the selenium moiety. As no in vivo toxicokinetic data or in vitro bioaccessibility data are available for a comparative assessment of relative bioavailability of various selenite substances, water solubility is adopted as a surrogate for bioavailability. Disodium selenite is readily soluble, with a water solubility of 800-900 g/L at 20°C. Barium selenite and zinc selenite, on the other hand, are poorly soluble salts (water solubility at 20°C of 66.7 mg/L and 16 mg/L, respectively, i.e. a difference of four/five orders of magnitude). Based on that, an intrinsically very conservative read-across from highly soluble forms to the poorly soluble barium/zinc selenite is proposed as the latter are assumed to have a lower solubility. It should also be noted that selenite anions in the tests with disodium selenite are formed under most physiological relevant conditions (i.e. neutral pH), thus facilitating unrestricted read-across between the various substances. In slightly acid conditions (pKa:8.32) the hydrogen selenite ion (HSeO3-) is formed whereas in more acidic conditions (pKa:2.62) the formation of selenious acid is observed (H2SeO3). Based on such existing equilibrium conditions, read-across between selenites, hydrogen selenites and selenious acid (solubility of 1670 g/L at 20°C) is justified.   Read-across from sodium selenite and selenious acid to barium/zinc selenite Based on a comparison between toxicity reference values of zinc compounds and selenium compounds, it can safely be assumed that the selenium/selenite moiety of zinc selenite is generally of higher toxicological relevance than the zinc cations. Comparing the DNELs for the zinc/barium ion itself with the zinc/barium levels that are associated with the DNELs for barium/zinc selenite (based on selenite-data) indicated significantly higher values (in the range of factor 10 to 20) for the DNELs derived for the barium/zinc ion itself. Therefore, the subsequent assessment of the toxicity of barium/zinc selenite focuses on the selenium moiety. Several reliable short-term repeated dose and sub-chronic studies are availble for the oral route: Abdo (1994), NOAEL rat: 0.4 mg Se/kg bw/d (sub-chronic test with sodium selenite), NOAEL 0.4 mg Se/kg bw/d (sub-chronic test with sodium selenate) Abdo (1994), NOAEL mouse: 0.9 mg Se/kg bw/d (sub-chronic test with sodium selenite), NOAEL 0.8 mg Se/kg bw/d (sub-chronic test with sodium selenate) Bioulac (1992), NOAEL rat: 0.12 mg Se/kg bw/d (test with sodium selenite) Johnson (2000), NOAEL mouse: 0.36 mg Se/kg bw/d (test with sodium selenite) Based on these data, a NOAEL for rats of 0.4 mg Se/ kg bw/day has been selected as the key value for repeated dose toxicity via the oral route for the different Se-compounds within the current category. No studies on repeated dose toxicity via inhalation or dermal route are available. Yang et al. (1989): NOAEL man: Se-intake of 850 µg Se/day per person; this figure is used as starting point for DNEL derivation. It has to be emphasized, that the NOAEL according to Yang et al. (1989), which is used as starting point for DNEL derivation is based on human data. The existing studies on humans are considering a wealth of toxicological endpoints and overrule the available animal-based data by far. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d5d35c2c-9958-4e58-87d6-23538ec4823e/documents/30d5079a-ed1c-46c0-9356-591bb2ca169c_d8118bd4-1aee-4017-be05-1cb12e68cbb0.html,,,,,, Selenium,7782-49-2," Selenium metal (powder, crude): Acute oral toxicity: LD0 of 5000 mg/kg dw (Prinsen 1996a,b) Acute inhalation toxicity: LD0 of 5.67 mg/L air (Bennick, 1996) Dermal toxicity: waived ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5d35c2c-9958-4e58-87d6-23538ec4823e/documents/df344811-0457-4df2-894f-7cd8fe236862_d8118bd4-1aee-4017-be05-1cb12e68cbb0.html,,,,,, Selenium,7782-49-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5d35c2c-9958-4e58-87d6-23538ec4823e/documents/df344811-0457-4df2-894f-7cd8fe236862_d8118bd4-1aee-4017-be05-1cb12e68cbb0.html,,oral,LD50,7 mg/kg bw,adverse effect observed, Selenium,7782-49-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5d35c2c-9958-4e58-87d6-23538ec4823e/documents/df344811-0457-4df2-894f-7cd8fe236862_d8118bd4-1aee-4017-be05-1cb12e68cbb0.html,,inhalation,LC50,0.052 mg/m3,adverse effect observed, "Distillates (coal tar), light oils",84650-03-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15e42f04-d6b1-4355-b4fe-e288a3eab160/documents/IUC5-c556af74-e651-4ca6-b170-874061c0bbbf_737d362a-b051-4177-8af5-31fd9e8d7540.html,,oral,LD50,"2,000 mg/kg bw",, "Tar bases, coal, lutidine fraction",91082-52-9," Oral route 28-day oral repeated dose toxicity study, rat: NOAEL = 80 mg/kg bw/day Inhalation route 28-day inhalation repeated dose toxicity study, rat, NOAEC = 207 mg/m3 Dermal route No study available ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/26080953-dcc9-4f68-b4d6-53af0da7bfa1/documents/3d84df37-22c4-4b8e-a858-486999cc827d_fc7c3a1d-71c1-4671-af3c-a93e98f9536b.html,,,,,, "Tar bases, coal, lutidine fraction",91082-52-9,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/26080953-dcc9-4f68-b4d6-53af0da7bfa1/documents/3d84df37-22c4-4b8e-a858-486999cc827d_fc7c3a1d-71c1-4671-af3c-a93e98f9536b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat "Tar bases, coal, lutidine fraction",91082-52-9,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/26080953-dcc9-4f68-b4d6-53af0da7bfa1/documents/3d84df37-22c4-4b8e-a858-486999cc827d_fc7c3a1d-71c1-4671-af3c-a93e98f9536b.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,207 mg/m3,,rat "Tar bases, coal, lutidine fraction",91082-52-9,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/26080953-dcc9-4f68-b4d6-53af0da7bfa1/documents/3d84df37-22c4-4b8e-a858-486999cc827d_fc7c3a1d-71c1-4671-af3c-a93e98f9536b.html,Repeated dose toxicity – local effects,inhalation,NOAEC,207 mg/m3,no adverse effect observed,rat "Tar bases, coal, lutidine fraction",91082-52-9," Oral route Acute oral toxicity, rat, female: LD50 = 971 mg/kg bw (758 - 1245 mg/kg bw, 95% confidence interval) Acute oral toxicity, rat, male: LD50 = 1239 mg/kg bw (943 - 1629 mg/kg bw, 95% confidence interval) Inhalation route Acute inhalation toxicity, rat, female/male: LC50 >3.61 mg/L (no deaths occurred) Dermal route Acute dermal toxicity, rat, female: LD50 = 236 mg/kg bw (190 - 293 mg/kg bw, 95% confidence interval) Acute dermal toxicity, rat, male: LD50 = 316 mg/kg bw (250 - 400 mg/kg bw, 95% confidence interval) ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26080953-dcc9-4f68-b4d6-53af0da7bfa1/documents/40753159-6f55-4734-8c74-0f08732f5e0b_fc7c3a1d-71c1-4671-af3c-a93e98f9536b.html,,,,,, "Tar bases, coal, lutidine fraction",91082-52-9,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26080953-dcc9-4f68-b4d6-53af0da7bfa1/documents/40753159-6f55-4734-8c74-0f08732f5e0b_fc7c3a1d-71c1-4671-af3c-a93e98f9536b.html,,oral,LD50,971 mg/kg bw,adverse effect observed, "Tar bases, coal, lutidine fraction",91082-52-9,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26080953-dcc9-4f68-b4d6-53af0da7bfa1/documents/40753159-6f55-4734-8c74-0f08732f5e0b_fc7c3a1d-71c1-4671-af3c-a93e98f9536b.html,,dermal,LD50,236 mg/kg bw,adverse effect observed, Cadmium sulphide,1306-23-6,"Available NOAELs from repeated dose oral and inhalation studies range between 0.12 - 3 mg/kg bw/day (studies with cadmium chloride) and 0.013. 10-3- 0.022 x 10-3mg/L (studies with cadmium oxide), respectively.Repeated dose toxicity of cadmium via the dermal route is not expected given the relatively low skin penetration of all forms of this metal. Also in view of the risk reduction measures which need to be taken as a result of the carcinogenicity of cadmium metal and some of the cadmium compounds, chronic dermal toxicity is not expected to be an issue for human health. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7870d67c-db5a-4023-a2f2-9a5350bcc8be/documents/IUC5-a0893971-c84e-46db-99ae-ef7a59aaafe4_4d4b340c-c3af-4a78-b0aa-5a1c6e63b53a.html,,,,,, Cadmium sulphide,1306-23-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7870d67c-db5a-4023-a2f2-9a5350bcc8be/documents/IUC5-a0893971-c84e-46db-99ae-ef7a59aaafe4_4d4b340c-c3af-4a78-b0aa-5a1c6e63b53a.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.013 mg/m3,,"hamster, Syrian" Cadmium sulphide,1306-23-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7870d67c-db5a-4023-a2f2-9a5350bcc8be/documents/IUC5-a0893971-c84e-46db-99ae-ef7a59aaafe4_4d4b340c-c3af-4a78-b0aa-5a1c6e63b53a.html,Chronic toxicity – systemic effects,oral,NOAEL,0.12 mg/kg bw/day,,monkey Cadmium sulphide,1306-23-6,"Although original studies were not available, data for cadmium oxide and cadmium metal powder suggest that the slightly soluble or insoluble forms of cadmium (like also cadmium hydroxide and cadmium carbonate) may present lower oral acute toxicity. To date, they are not classified for this endpoint.Cadmium sulphide, being insoluble, is not expected to be as readily bioavailable and therefore is likely to have lower toxicity. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7870d67c-db5a-4023-a2f2-9a5350bcc8be/documents/IUC5-1fc0e3f0-05ae-406d-a4ef-a28725254bfe_4d4b340c-c3af-4a78-b0aa-5a1c6e63b53a.html,,,,,, Cadmium sulphide,1306-23-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7870d67c-db5a-4023-a2f2-9a5350bcc8be/documents/IUC5-1fc0e3f0-05ae-406d-a4ef-a28725254bfe_4d4b340c-c3af-4a78-b0aa-5a1c6e63b53a.html,,oral,LD50,"2,330 mg/kg bw",, "Naphtha (petroleum), unsweetened",68783-12-0,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/870fddaa-2be8-45d0-ab86-5a36d931d0bd/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_c923e7a2-474b-4982-a1c7-7e157cd47277.html,,,,,, "Naphtha (petroleum), unsweetened",68783-12-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/870fddaa-2be8-45d0-ab86-5a36d931d0bd/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_c923e7a2-474b-4982-a1c7-7e157cd47277.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), unsweetened",68783-12-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/870fddaa-2be8-45d0-ab86-5a36d931d0bd/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_c923e7a2-474b-4982-a1c7-7e157cd47277.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), unsweetened",68783-12-0," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/870fddaa-2be8-45d0-ab86-5a36d931d0bd/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_c923e7a2-474b-4982-a1c7-7e157cd47277.html,,,,,, "Naphtha (petroleum), unsweetened",68783-12-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/870fddaa-2be8-45d0-ab86-5a36d931d0bd/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_c923e7a2-474b-4982-a1c7-7e157cd47277.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), unsweetened",68783-12-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/870fddaa-2be8-45d0-ab86-5a36d931d0bd/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_c923e7a2-474b-4982-a1c7-7e157cd47277.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), unsweetened",68783-12-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/870fddaa-2be8-45d0-ab86-5a36d931d0bd/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_c923e7a2-474b-4982-a1c7-7e157cd47277.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, p-toluidine,106-49-0,"Migrated Data from field(s)Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): There are no reliable studies available for p-Toluidine . Therefore, the Read Across approach was chosen to fill the datagap. In an OECD TG 422 rat study m-toluidine was examined yielding a LOAEL of 30 mg/kg bw/day whereas p-Isopropyl aniline showed a NOAEL of 6 mg/kg bw/day ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc0c9824-6d36-4f0a-bf33-193d0d7afb32/documents/IUC5-3faceea6-4c40-499e-bd68-8a1e0ac3b661_65ac825b-152e-41a1-a775-0eb7e50d19da.html,,,,,, p-toluidine,106-49-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc0c9824-6d36-4f0a-bf33-193d0d7afb32/documents/IUC5-3faceea6-4c40-499e-bd68-8a1e0ac3b661_65ac825b-152e-41a1-a775-0eb7e50d19da.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,6 mg/kg bw/day,,rat p-toluidine,106-49-0,Acute Toxicity:Oral: LD50:620 mg/kg bwDermal: LD50: 890 mg/kg bw ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc0c9824-6d36-4f0a-bf33-193d0d7afb32/documents/IUC5-1225f4e2-4748-4902-944d-f4a173ea1ab5_65ac825b-152e-41a1-a775-0eb7e50d19da.html,,,,,, p-toluidine,106-49-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc0c9824-6d36-4f0a-bf33-193d0d7afb32/documents/IUC5-1225f4e2-4748-4902-944d-f4a173ea1ab5_65ac825b-152e-41a1-a775-0eb7e50d19da.html,,oral,LD50,620 mg/kg bw,adverse effect observed, p-toluidine,106-49-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc0c9824-6d36-4f0a-bf33-193d0d7afb32/documents/IUC5-1225f4e2-4748-4902-944d-f4a173ea1ab5_65ac825b-152e-41a1-a775-0eb7e50d19da.html,,dermal,LD50,890 mg/kg bw,adverse effect observed, "2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",57583-34-3,"90-Day Repeated Dose Toxicity: Oral Route - Swathi (2020) Under the conditions of the study, based on the observed results and considering the decrease in body weight, feed consumption at 5 000 (G4) and 12 000/4 000 ppm (G5) and microscopic findings observed in brain and thymus which included neuronal necrosis in piriform cortex and/or cornu ammonis (CA1 &2) of the brain and depletion of lymphocytes in thymus at 5 000 (G4) and at 12 000/4 000 ppm (G5) in both sexes, the No Observed Adverse Effect Level (NOAEL) of the test material is 2 000 ppm in the diet (163.12 mg/kg bw/day males; 199.52 mg/kg bw/day females) when administered for a period of 91 consecutive days by oral (dietary) route to Sprague Dawley rats. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef22f6db-4295-4e35-9333-ee83dc966434/documents/22b0e474-5961-4017-9ccc-d053f7bb40d2_af54460a-2d7e-4abf-8c6a-f9cb4f54bbff.html,,,,,, "2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",57583-34-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef22f6db-4295-4e35-9333-ee83dc966434/documents/22b0e474-5961-4017-9ccc-d053f7bb40d2_af54460a-2d7e-4abf-8c6a-f9cb4f54bbff.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,163.12 mg/kg bw/day,,rat "2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",57583-34-3,"Oral: LD50 880 mg/kg (rat) Dermal: LD50 1000 mg/kg in female rabbits; LD50 2150 mg/kg in male rabbits Inhalation: The LC50 (1h) was 240 mg/L in male and female rats. This value was calculated from 1 h exposure to the standard exposure duration of 4 h by dividing the LC50 (1h) value by a factor of 2 in accordance with Regulation (EC) No 1272/2008, table 3.1.1, note (b). The resulting LC50 (4h) is 120 mg/L.  ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef22f6db-4295-4e35-9333-ee83dc966434/documents/7bfe8aeb-8fe5-40bd-8d48-7d9cb220a166_af54460a-2d7e-4abf-8c6a-f9cb4f54bbff.html,,,,,, "2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",57583-34-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef22f6db-4295-4e35-9333-ee83dc966434/documents/7bfe8aeb-8fe5-40bd-8d48-7d9cb220a166_af54460a-2d7e-4abf-8c6a-f9cb4f54bbff.html,,oral,LD50,880 mg/kg bw,adverse effect observed, "2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",57583-34-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef22f6db-4295-4e35-9333-ee83dc966434/documents/7bfe8aeb-8fe5-40bd-8d48-7d9cb220a166_af54460a-2d7e-4abf-8c6a-f9cb4f54bbff.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, "2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-4-methyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",57583-34-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef22f6db-4295-4e35-9333-ee83dc966434/documents/7bfe8aeb-8fe5-40bd-8d48-7d9cb220a166_af54460a-2d7e-4abf-8c6a-f9cb4f54bbff.html,,inhalation,LC50,"120,000 mg/m3",adverse effect observed, Gallium arsenide,1303-00-0," Effects of gallium arsenide on male and female rats and mice were examined in 16-day, 14-week and 2-year inhalation toxicity studies (NTP, 2000; Ma-Hock, 2016). Pulmonary alveolar proteinosis leading to chronic active inflammation of the lung were seen in rats and mice as a specific toxic reaction to the inhalation of a GaAs dust (MMAD < 2 µm). ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df0c23a5-0438-4bf5-944a-35be8eb89b57/documents/IUC5-63b001c6-00c1-4b11-9906-9176875611b7_19458403-9080-4412-a9fa-2eada160f44f.html,,,,,, Gallium arsenide,1303-00-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df0c23a5-0438-4bf5-944a-35be8eb89b57/documents/IUC5-63b001c6-00c1-4b11-9906-9176875611b7_19458403-9080-4412-a9fa-2eada160f44f.html,Chronic toxicity – systemic effects,inhalation,LOAEC,0.01 mg/m3,,rat Gallium arsenide,1303-00-0, There are 2 key studies with sufficient reliability: one with oral administration and one with dermal application. Further 2 studies with oral administration and 6 studies with administration of GaAs by other routes have no sufficient reliability and are therefore ignored.A single dosage of 10000 mg GaAs/kg bw either administered orally or applied dermally had no effect.According to the results of these 2 studies GaAs can be classified as practically nontoxic and a classification for acute toxicity is not required. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df0c23a5-0438-4bf5-944a-35be8eb89b57/documents/IUC5-a21e8e3a-c1d2-4efa-87cf-2ede9911470b_19458403-9080-4412-a9fa-2eada160f44f.html,,,,,, "Distillates (coal tar), pitch",101316-49-8,"Anthracene oil is expected to show little acute toxicity, based on results obtained from closely related tar oils: LD50(oral, rat) ~ 4000 mg/kg bw, LD50(dermal, rat) > 2000 mg/kg bw. No acute intoxication is expected from inhalation exposure, given the low vapour pressure and observed low toxicity of this test substance. Inhalation will be assessed for repeated exposure (see IUCLID 7.5.3). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2188f700-cd9a-4ccc-82fc-09200d19f66f/documents/IUC5-6be6be1c-458b-4db9-b705-f2a5d1ed16de_84cdfe91-ef9c-4833-8acf-7e7d3b41068e.html,,,,,, Spirodiclofen,148477-71-8,"The Key Studies for the repeated dose toxicity endpoint are as follows: 90-day oral (dietary) rat study (M-005766-02-1) 12-month oral (dietary) dog study (M-045424-02-1) 28-day dermal toxicity study in the rat (M-011043-01-1) A number of Supporting Studies are also available: 28-day oral (dietary) rat study (M-024721-01-1) 28-day oral (dietary) dog study (M-027510-02-1) 8-week investigative oral (dietary) dog study (M-052495-01-1) 90-day oral (dietary) mouse study (M-005729-03-1) 90-day oral (dietary) dog study (M-032514-02-1) Non-standard 19-week oral (dietary) rat study (M-049165-01-1) Chronic toxicity/carcinogenicity studies are also available in the rat (M-026284-02-1) and in the mouse (M-044116-01-1). The lowest NOAEL (1.45 mg/kg bw/d) is reported in the 12-month oral (dietary) dog study (M-045424-02-1); however, the mouse chronic toxicity/carcinogenicity study does not identify a NOAEL (LOAEL =4.1 mg/kg bw/d). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): A GLP- and guideline compliant 28-day dermal toxicity study in the rat (Klimisch =1) is available Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): A GLP- and guideline compliant 28-day dermal toxicity study in the rat (Klimisch =1) is available Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A comprehensive and high-quality database of repeated dose oral toxicity studies of up to chronic duration are available for the rat, mouse and dog. A sub-acute dermal toxicity study is also available for the rat. The key studies are GLP- and guideline-compliant; the supporting studies include guideline-compliant and non-guideline investigative studies. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b3b75b1-670b-4d78-8de5-7251136ce515/documents/8031e9c0-88e0-4e27-a39e-1989c887a1ed_1991f84d-307c-47b5-b1ef-5201f36a6d8a.html,,,,,, Spirodiclofen,148477-71-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b3b75b1-670b-4d78-8de5-7251136ce515/documents/8031e9c0-88e0-4e27-a39e-1989c887a1ed_1991f84d-307c-47b5-b1ef-5201f36a6d8a.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat Spirodiclofen,148477-71-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b3b75b1-670b-4d78-8de5-7251136ce515/documents/8031e9c0-88e0-4e27-a39e-1989c887a1ed_1991f84d-307c-47b5-b1ef-5201f36a6d8a.html,Chronic toxicity – systemic effects,oral,NOAEL,1.45 mg/kg bw/day,,dog Spirodiclofen,148477-71-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b3b75b1-670b-4d78-8de5-7251136ce515/documents/8031e9c0-88e0-4e27-a39e-1989c887a1ed_1991f84d-307c-47b5-b1ef-5201f36a6d8a.html,Repeated dose toxicity – local effects,dermal,,"1,000 ",no adverse effect observed,rat Spirodiclofen,148477-71-8,"An acute oral toxicity study in the rat is available (GLP, draft OECD 423). An acute inhalation toxicity study in the rat is available (GLP, OECD 403). An acute dermal toxicity study in the rat is available (GLP, OECD 402). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): An acute oral toxicity study in the rat is available (GLP, draft OECD 423; Klimisch 1). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): An acute inhalation toxicity study in the rat is available (GLP, OECD 403; Klimisch 2). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): An acute dermal toxicity study in the rat is available (GLP, OECD 403; Klimisch 1). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b3b75b1-670b-4d78-8de5-7251136ce515/documents/de12fd72-7305-479e-9c4b-1516ed5c6d9b_1991f84d-307c-47b5-b1ef-5201f36a6d8a.html,,,,,, Spirodiclofen,148477-71-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b3b75b1-670b-4d78-8de5-7251136ce515/documents/de12fd72-7305-479e-9c4b-1516ed5c6d9b_1991f84d-307c-47b5-b1ef-5201f36a6d8a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Spirodiclofen,148477-71-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b3b75b1-670b-4d78-8de5-7251136ce515/documents/de12fd72-7305-479e-9c4b-1516ed5c6d9b_1991f84d-307c-47b5-b1ef-5201f36a6d8a.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Spirodiclofen,148477-71-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b3b75b1-670b-4d78-8de5-7251136ce515/documents/de12fd72-7305-479e-9c4b-1516ed5c6d9b_1991f84d-307c-47b5-b1ef-5201f36a6d8a.html,,inhalation,LC50,> 5.03 mg/L,no adverse effect observed, Cadmium carbonate,513-78-0,"Available NOAELs from repeated dose oral and inhalation studies range between 0.12 - 3 mg/kg bw/day (studies with cadmium chloride) and 0.013. 10-3- 0.022 x 10-3mg/L (studies with cadmium oxide), respectively.Repeated dose toxicity of cadmium via the dermal route is not expected given the relatively low skin penetration of all forms of this metal. Also in view of the risk reduction measures which need to be taken as a result of the carcinogenicity of cadmium metal and some of the cadmium compounds, chronic dermal toxicity is not expected to be an issue for human health. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de3c5cc4-09a2-4a92-9395-785a032545b9/documents/IUC5-a75a4b5a-9cba-4217-acbd-885a763f0899_37e8ab47-34e7-4c30-b5f2-31aacdd7a484.html,,,,,, Cadmium carbonate,513-78-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de3c5cc4-09a2-4a92-9395-785a032545b9/documents/IUC5-a75a4b5a-9cba-4217-acbd-885a763f0899_37e8ab47-34e7-4c30-b5f2-31aacdd7a484.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.013 mg/m3,,"hamster, Syrian" Cadmium carbonate,513-78-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de3c5cc4-09a2-4a92-9395-785a032545b9/documents/IUC5-a75a4b5a-9cba-4217-acbd-885a763f0899_37e8ab47-34e7-4c30-b5f2-31aacdd7a484.html,Chronic toxicity – systemic effects,oral,NOAEL,0.12 mg/kg bw/day,,monkey Cadmium carbonate,513-78-0,"Although original studies were not available, data for cadmium oxide and cadmium metal powder suggest that the slightly soluble or insoluble forms ofcadmium (like also cadmium hydroxide and cadmium carbonate) may present lower oral acute toxicity than the soluble cadmium compounds. To date, they are not classified for this endpoint. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de3c5cc4-09a2-4a92-9395-785a032545b9/documents/IUC5-f71629b6-28e2-4d88-8be9-0f02789b1945_37e8ab47-34e7-4c30-b5f2-31aacdd7a484.html,,,,,, Cadmium carbonate,513-78-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de3c5cc4-09a2-4a92-9395-785a032545b9/documents/IUC5-f71629b6-28e2-4d88-8be9-0f02789b1945_37e8ab47-34e7-4c30-b5f2-31aacdd7a484.html,,oral,LD50,"2,330 mg/kg bw",, Cadmium carbonate,513-78-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de3c5cc4-09a2-4a92-9395-785a032545b9/documents/IUC5-f71629b6-28e2-4d88-8be9-0f02789b1945_37e8ab47-34e7-4c30-b5f2-31aacdd7a484.html,,inhalation,LC50,66 mg/m3,, Trichloroacetic acid,76-03-9,Repeated dose toxicity: oral. Key studies: Read-across: experimental results with the substance sodium trichloroacetate. ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6756b5ab-3366-4413-9ed7-e44eaf36f75e/documents/IUC5-27ac0f09-9002-493a-96aa-a3f9d6439187_ea42a050-3a0e-4d66-9e82-15b8b9c089db.html,,,,,, Trichloroacetic acid,76-03-9,"Data waiving: In accordance with column 2 of REACH Annex VII and VIII, the studies do not need to be conducted since the test substance is classified as corrosive. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6756b5ab-3366-4413-9ed7-e44eaf36f75e/documents/IUC5-8dc1f768-5cb4-4d3f-80dd-7c06753fa979_ea42a050-3a0e-4d66-9e82-15b8b9c089db.html,,,,,, Cobalt dinitrate,10141-05-6,Acute oral toxicity:LD50= 691mg cobalt dinitrate hexahydrate /kg bw (confidence interval: 526 - 907 mg/kg bw)Acute dermal toxicity:Conduct of an acute dermal toxicity study for cobalt dinitrate is unjustified since dermal uptake is considered negligible.Acute inhalation toxicity:The classification from the acute oral toxicity is read-across to the acute toxicity via inhalation. Further results from the ongoing testing programme will be included upon availability. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f0251e6-1535-4cd0-8aab-a0385c2c871c/documents/IUC5-a11c187f-6c9b-474e-94a7-4ffba16423fb_14003e3a-15ce-498e-b620-2d3731310943.html,,,,,, Cobalt dinitrate,10141-05-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f0251e6-1535-4cd0-8aab-a0385c2c871c/documents/IUC5-a11c187f-6c9b-474e-94a7-4ffba16423fb_14003e3a-15ce-498e-b620-2d3731310943.html,,oral,LD50,691 mg/kg bw,no adverse effect observed, 2-chloro-N-(ethoxymethyl)-N-(2-ethyl-6-methylphenyl)acetamide,34256-82-1,"Oral Key; M-771676-01-1; subchronic (13 w, rat): NOAEL: (oral) 16.1 mg/kg bw/day (males) and 18.8 mg/kg bw/day (females), LOAEL: 161.1 mg/kg bw/day (males) and 191.9 mg/kg bw/day (females) Key; M-771556-01-1; subchronic (13 w, dog): NOAEL: (oral) 10 mg/kg bw/day (males and females), LOAEL: (oral) 60 mg/kg bw/day (males and females) Key; M-705758-01-1; subchronic (1 y, dog): NOAEL: 4 mg/kg bw/day (males and females), LOAEL: 12 mg/kg bw/day (males and females) Key, M-705341-01-2; subchronic (1y, dog): NOAEL: 2 mg/kg bw/day (males and females), LOAEL: 10 mg/kg bw/day (males and females) Key; M-771436-01-1; chronic (2 y, rat): NOAEL: (systemic toxicity and carcinogenicity) 6.37 mg/kg bw/day (males), 8.53 mg/kg bw/day (females), LOAEL: (systemic toxicity and carcinogenicity): 66.9 mg/kg bw/day (males), 92.1 mg/kg bw/day (females) Key; M-697164-01-1 (sup. M-692906-01-1); chronic (2 y, rat): LOAEL: (systemic toxicity) 22 mg/kg bw/day (males), 30 mg/kg bw/day (females), NOAEL: (carcinogenicity): 22 mg/kg bw/day (males), 30 mg/kg bw/day (females), LOAEL: (carcinogenicity): 69 mg/kg bw/day (males), 93 mg/kg bw/day (females) Key; M-710443-01-1; chronic (2 y, rat): NOAEL (systemic toxicity and carcinogenicity): 9.4 mg/kg bw/day (males), 11.8 mg/kg bw/day (females), LOAEL (systemic toxicity and carcinogenicity): 47.5 mg/kg bw/day (males), 60.0 mg/kg bw/day (females)   Dermal Key, M-771472-01-1; subacute (21 d, rat, OECD 410, GLP): NOAEL (systemic and local): ≥ 100 mg/kg bw/day (males and females)   Supporting, M-698632-01-1; subacute (21 d, rabbit, OECD 410, GLP):NOAEL (systemic): 400 mg/kg bw/day, LOAEL (systemic): 1200 mg/kg bw/dayLOAEL (local effects): 100 mg/kg bw/day ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7fab699-5aa8-4e41-bfa3-c8c3b6872097/documents/58342252-8c46-410a-be1f-76660fcf8cfc_faa80813-917e-49e6-b77e-9bec4aecadde.html,,,,,, 2-chloro-N-(ethoxymethyl)-N-(2-ethyl-6-methylphenyl)acetamide,34256-82-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7fab699-5aa8-4e41-bfa3-c8c3b6872097/documents/58342252-8c46-410a-be1f-76660fcf8cfc_faa80813-917e-49e6-b77e-9bec4aecadde.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,,rat 2-chloro-N-(ethoxymethyl)-N-(2-ethyl-6-methylphenyl)acetamide,34256-82-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7fab699-5aa8-4e41-bfa3-c8c3b6872097/documents/58342252-8c46-410a-be1f-76660fcf8cfc_faa80813-917e-49e6-b77e-9bec4aecadde.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,2 mg/kg bw/day,,dog 2-chloro-N-(ethoxymethyl)-N-(2-ethyl-6-methylphenyl)acetamide,34256-82-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7fab699-5aa8-4e41-bfa3-c8c3b6872097/documents/58342252-8c46-410a-be1f-76660fcf8cfc_faa80813-917e-49e6-b77e-9bec4aecadde.html,Chronic toxicity – systemic effects,oral,NOAEL,6.37 mg/kg bw/day,,rat 2-chloro-N-(ethoxymethyl)-N-(2-ethyl-6-methylphenyl)acetamide,34256-82-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7fab699-5aa8-4e41-bfa3-c8c3b6872097/documents/58342252-8c46-410a-be1f-76660fcf8cfc_faa80813-917e-49e6-b77e-9bec4aecadde.html,Repeated dose toxicity – local effects,dermal,LOAEL,0.149 mg/cm2,adverse effect observed,rabbit 2-chloro-N-(ethoxymethyl)-N-(2-ethyl-6-methylphenyl)acetamide,34256-82-1,"Oral (similar to OECD 401), rat: LD50 = 2389 mg/kg bw (males), 1929 mg/kg bw (females) Oral (similar to OECD 401), rat: LD50 = 4238 mg/kg bw (males), 4015 mg/kg bw (females) Inhalation (similar to OECD 403), rat: LC50 > 4.46 mg/L (males), 3.99 mg/L (females) Dermal (similar to OECD 402), rabbit: LD50 = 4166 mg/kg bw (males and females combined), LD50 = 3856 mg/kg bw (females) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7fab699-5aa8-4e41-bfa3-c8c3b6872097/documents/3e324db1-c28c-44a9-956f-dd84cd22b62b_faa80813-917e-49e6-b77e-9bec4aecadde.html,,,,,, 2-chloro-N-(ethoxymethyl)-N-(2-ethyl-6-methylphenyl)acetamide,34256-82-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7fab699-5aa8-4e41-bfa3-c8c3b6872097/documents/3e324db1-c28c-44a9-956f-dd84cd22b62b_faa80813-917e-49e6-b77e-9bec4aecadde.html,,oral,LD50,"1,929 mg/kg bw",adverse effect observed, 2-chloro-N-(ethoxymethyl)-N-(2-ethyl-6-methylphenyl)acetamide,34256-82-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7fab699-5aa8-4e41-bfa3-c8c3b6872097/documents/3e324db1-c28c-44a9-956f-dd84cd22b62b_faa80813-917e-49e6-b77e-9bec4aecadde.html,,dermal,LD50,"3,856 mg/kg bw",adverse effect observed, 2-chloro-N-(ethoxymethyl)-N-(2-ethyl-6-methylphenyl)acetamide,34256-82-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7fab699-5aa8-4e41-bfa3-c8c3b6872097/documents/3e324db1-c28c-44a9-956f-dd84cd22b62b_faa80813-917e-49e6-b77e-9bec4aecadde.html,,inhalation,LC50,3.99 mg/L,adverse effect observed, Cobalt di(acetate),71-48-7,Acute oral toxicity:LD50= 708 mg cobalt diacetate tetrahydrate/kg bw (confidence interval: 569-880 mg/kg bw)Acute dermal toxicity:Conduct of an acute dermal toxicity study for cobalt di(acetate) is unjustified since dermal uptake is considered negligible.Acute inhalation toxicity:The classification from the acute oral toxicity is read-across to the acute toxicity via inhalation. Further results from the ongoing testing programme will be included upon availability. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0cf98d09-fd93-4ee0-9514-ae668256f0a9/documents/IUC5-d93c82b9-de9b-4862-bf21-db1fd5331499_3906e6e6-24d7-4eef-862c-8b7ba6749abe.html,,,,,, Cobalt di(acetate),71-48-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0cf98d09-fd93-4ee0-9514-ae668256f0a9/documents/IUC5-d93c82b9-de9b-4862-bf21-db1fd5331499_3906e6e6-24d7-4eef-862c-8b7ba6749abe.html,,oral,LD50,708 mg/kg bw,adverse effect observed, Quinoline,91-22-5,"No NOAEL is available however, the target organ has been identified (liver) and as quinoline produces early onset hepatocarcinogenesis, a NOAEL should be hardly obtained in repeated studies (no threshold). ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a867be09-169b-4bae-81ff-1e34a59fbb54/documents/IUC5-84e1e16e-fef8-455e-9b0f-fd2ea7340718_c345642a-00d0-492b-a98c-603d24b0783c.html,,,,,, Quinoline,91-22-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a867be09-169b-4bae-81ff-1e34a59fbb54/documents/IUC5-84e1e16e-fef8-455e-9b0f-fd2ea7340718_c345642a-00d0-492b-a98c-603d24b0783c.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,20 mg/kg bw/day,,rat Quinoline,91-22-5,Quinoline is considered as harmful by oral and dermal route according to the Dangerous Substance Directive criteria. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a867be09-169b-4bae-81ff-1e34a59fbb54/documents/IUC5-71b34e5b-a74b-42d8-a1ed-6b22b3b7f534_c345642a-00d0-492b-a98c-603d24b0783c.html,,,,,, Quinoline,91-22-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a867be09-169b-4bae-81ff-1e34a59fbb54/documents/IUC5-71b34e5b-a74b-42d8-a1ed-6b22b3b7f534_c345642a-00d0-492b-a98c-603d24b0783c.html,,oral,LD50,262 mg/kg bw,adverse effect observed, Quinoline,91-22-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a867be09-169b-4bae-81ff-1e34a59fbb54/documents/IUC5-71b34e5b-a74b-42d8-a1ed-6b22b3b7f534_c345642a-00d0-492b-a98c-603d24b0783c.html,,dermal,LD50,"1,377 mg/kg bw",adverse effect observed, "Dibutylbis(pentane-2,4-dionato-O,O')tin",22673-19-4,"The following studies have been submitted to address the repeated dose toxicity: oral endpoint:Waalkens-Berendsen DH (2003) Dibutyldichlorostannane (CAS # 683-18-1): Reproduction/developmental toxicity screening test in rats, TNO, Project Organisation, Ecotoxicology, Utrechtseweg 48, P.O. Box 370, 3700 AJ Zeist, The Netherlands, Report No.: V 4906, Organotin Environmental Programme (ORTEP) Association, Stabilizer Task Force. Report Date.: 2003-12-04. studBarnes, J. M. and Stoner, H. B. (1958). Toxic properties of some dialkyl and trialkyl tin salts. Brit. J. Industr. Med., 1958, 15, 15.Gaunt et al (1968). Acute and Short-term Toxicity Studies on Di-n-butyltin Dichloride in Rats. Fd Cosmet. Toxicol. Vol. 6, pp. 599-608.Penninks A. H. & Seinen W. (1982). COMPARATIVE TOXICITY OF ALKYLTIN AND ESTERTIN STABILIZERS. Fd Chem. Toxic. Vol. 20. pp. 909 to 916.The Gaunt et al (1968) study has been allocated a Klimisch core of 2 on the basis that the study predates GLP; however, method was comparable to OECD Guideline 408. The effect of DBT exposure on the thymus of was not assessed in this study. No information on the stability or homogeneity of the test material in the DBTC-prepared diets. The study was performed with dibutyltin dichloride.The Penninks and Seinen (1982) study has also been allocated a Klimisch score of 2 on the basis that the study is a short-term feeding study with no information on the stability of the test substance in the diet or homogeneity of the test diets provided. The purity of the test substance (dibutyltin dichloride) is not reported. The Barnes and Stoner (1958) study has been allocated a Klimisch score of 4.Dibutyltin chloride was the test substance employed in all the studies presented under repeated dose toxicity. Under gastric conditions, the substance in question is anticipated to hydrolyse to dibutyltin chloride. A read-across approach from dibutyltin chloride was considered acceptable when dosing repeatedly via the oral route. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b078abd-5dc7-4f10-b381-907fdf652c27/documents/IUC5-49c563a5-9721-4340-b73f-c6e21ca0d023_72b1d554-8a4c-480f-8e06-277de72836a0.html,,,,,, "Dibutylbis(pentane-2,4-dionato-O,O')tin",22673-19-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b078abd-5dc7-4f10-b381-907fdf652c27/documents/IUC5-49c563a5-9721-4340-b73f-c6e21ca0d023_72b1d554-8a4c-480f-8e06-277de72836a0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.3 mg/kg bw/day,,rat "Dibutylbis(pentane-2,4-dionato-O,O')tin",22673-19-4,"The following study was submitted to address the acute toxicity: oral endpoint:Driscoll (1998). NEOSTANN U-220: ACUTE ORAL TOXICITY TEST IN THE RAT. Testing laboratory: Safepharm Laboratories Limited, P. O. Box No. 45, DERBY, DE1 2BT, UK. Report no.: 1194/001. Owner company: Nitto Kasei Co., Ltd., 17-14 Nishiawaji 3-chome, Higashiyodogawa-ku, Osaka, JAPAN. Report date: 1998-07-15.The test material was reported to have an acute oral median lethal dose (LD50) and 95% confidence limits of 1864 (1039 - 3344) mg/kg bodyweight (Females only)The following study was submitted to address the acute toxicity: dermal endpoint:Sanders (2010). ACUTE DERMAL TOXICITY (LIMIT TEST) IN THE RAT. Testing laboratory: Harlan Laboratories.Report no.: 3109/0061. Sponsor: Organo Tin REACH Consortium, c/o ReachCentrum, Avenue E. Van Nieuwenhuyse 6, B-1160, Brussels, BELGIUM.The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.A waiver has been submitted to address the acute toxicity: inhalation endpoint on the basis of lack of exposure. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b078abd-5dc7-4f10-b381-907fdf652c27/documents/IUC5-5d51067a-491d-4f4a-994f-d48a6ad41bb1_72b1d554-8a4c-480f-8e06-277de72836a0.html,,,,,, "Dibutylbis(pentane-2,4-dionato-O,O')tin",22673-19-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b078abd-5dc7-4f10-b381-907fdf652c27/documents/IUC5-5d51067a-491d-4f4a-994f-d48a6ad41bb1_72b1d554-8a4c-480f-8e06-277de72836a0.html,,oral,LD50,"1,864 mg/kg bw",, "Dibutylbis(pentane-2,4-dionato-O,O')tin",22673-19-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b078abd-5dc7-4f10-b381-907fdf652c27/documents/IUC5-5d51067a-491d-4f4a-994f-d48a6ad41bb1_72b1d554-8a4c-480f-8e06-277de72836a0.html,,dermal,LD50,"2,000 mg/kg bw",, "Tetrahydro-1,3-dimethyl-1H-pyrimidin-2-one",7226-23-5,"28-day stuy (OECD 407): NOAEL = 10 mg/kg bw/day (BASF SE/RCC, 1998) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/117ebe99-cf69-4c18-929e-d662abc88a2a/documents/IUC5-f160d6cc-fd04-4a5e-bc29-53e0d021f0f3_ec50640f-6cd3-4748-901d-de08792217a6.html,,,,,, "Tetrahydro-1,3-dimethyl-1H-pyrimidin-2-one",7226-23-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/117ebe99-cf69-4c18-929e-d662abc88a2a/documents/IUC5-f160d6cc-fd04-4a5e-bc29-53e0d021f0f3_ec50640f-6cd3-4748-901d-de08792217a6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "Tetrahydro-1,3-dimethyl-1H-pyrimidin-2-one",7226-23-5,"LD50 (oral, rat) = 1770 mg/kg bw (BASF SE, 1989; OECD 401)LD50 (dermal, rat, male/female) > 2000 mg/kg bw (BASF SE/Bioassay, 2012; OECD 402) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/117ebe99-cf69-4c18-929e-d662abc88a2a/documents/IUC5-2c696627-fa31-441c-b1e3-1f7e4ec9a371_ec50640f-6cd3-4748-901d-de08792217a6.html,,,,,, "Tetrahydro-1,3-dimethyl-1H-pyrimidin-2-one",7226-23-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/117ebe99-cf69-4c18-929e-d662abc88a2a/documents/IUC5-2c696627-fa31-441c-b1e3-1f7e4ec9a371_ec50640f-6cd3-4748-901d-de08792217a6.html,,oral,LD50,"1,770 mg/kg bw",adverse effect observed, "Tetrahydro-1,3-dimethyl-1H-pyrimidin-2-one",7226-23-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/117ebe99-cf69-4c18-929e-d662abc88a2a/documents/IUC5-2c696627-fa31-441c-b1e3-1f7e4ec9a371_ec50640f-6cd3-4748-901d-de08792217a6.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, Cobalt,7440-48-4,"Acute oral toxicity:LD50(male and female)=550 mg Co/kg bwAcute toxicity, inhalation:LC100(male and female)<50 µg Co/LAcute toxicity, dermal:Conduct of an acute dermal toxicity study is unjustified, since a dermal absorption study as well as the physicochemical properties of the substance do not suggest a significant rate of absorption through the skin (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08bdffd9-57d4-4685-afd8-4956205ebc25/documents/IUC5-dc55bf37-b10a-4fc4-b61b-55453316c219_af06b1fc-f8cc-4e93-a3ac-1fca63103084.html,,,,,, Cobalt,7440-48-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08bdffd9-57d4-4685-afd8-4956205ebc25/documents/IUC5-dc55bf37-b10a-4fc4-b61b-55453316c219_af06b1fc-f8cc-4e93-a3ac-1fca63103084.html,,oral,LD50,550 mg/kg bw,adverse effect observed, Cobalt,7440-48-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08bdffd9-57d4-4685-afd8-4956205ebc25/documents/IUC5-dc55bf37-b10a-4fc4-b61b-55453316c219_af06b1fc-f8cc-4e93-a3ac-1fca63103084.html,,inhalation,LC50,50 mg/m3,adverse effect observed, "Naphtha (petroleum), light catalytic cracked",64741-55-5,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea8b7f30-19f0-4e83-ad6f-5891fc502ff6/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_47d611dc-c0e1-408c-8ec4-b592f558e105.html,,,,,, "Naphtha (petroleum), light catalytic cracked",64741-55-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea8b7f30-19f0-4e83-ad6f-5891fc502ff6/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_47d611dc-c0e1-408c-8ec4-b592f558e105.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), light catalytic cracked",64741-55-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea8b7f30-19f0-4e83-ad6f-5891fc502ff6/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_47d611dc-c0e1-408c-8ec4-b592f558e105.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), light catalytic cracked",64741-55-5," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea8b7f30-19f0-4e83-ad6f-5891fc502ff6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_47d611dc-c0e1-408c-8ec4-b592f558e105.html,,,,,, "Naphtha (petroleum), light catalytic cracked",64741-55-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea8b7f30-19f0-4e83-ad6f-5891fc502ff6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_47d611dc-c0e1-408c-8ec4-b592f558e105.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light catalytic cracked",64741-55-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea8b7f30-19f0-4e83-ad6f-5891fc502ff6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_47d611dc-c0e1-408c-8ec4-b592f558e105.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light catalytic cracked",64741-55-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea8b7f30-19f0-4e83-ad6f-5891fc502ff6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_47d611dc-c0e1-408c-8ec4-b592f558e105.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, Diboron trioxide,1303-86-2,"A number of sub-chronic and chronic studies on boric acid and disodium tetraborate decahydrate were carried out in rats, mice and dogs. In some cases these studies are research studies (Weir and Fisher, 1972; Dixon et al, 1976; Seal and Weeth, 1980; Lee et al., 1978; Treinen and Chapin, 1991; Ku et al., 1993), but most support that boron can cause adverse haematological effects and that the main target organ of boron toxicity is the testis. The NOAEL for fertility effects is equivalent to 17.5 mg B/kg bw/day that corresponds to NOAEL of 56.3 mg Boric oxide /kg bw (Weir, 1966). The key developmental study provides BMDL05 which is based on results of two studies and therefore is more accurate and more precise than NOAEL established in one study. The oral BMDL05 has been extrapolated to inhalation BMCL05 of 58.4 mg/m³ for boric oxide by route-to-route extrapolation (see section ""DNEL derivation""). ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c46809a-602f-46f2-95a0-851ece07af8d/documents/d2c3bd65-0297-4889-884c-2a6e5833efcc_1a6b12b8-d788-4d12-9002-ad660518bf86.html,,,,,, Diboron trioxide,1303-86-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c46809a-602f-46f2-95a0-851ece07af8d/documents/d2c3bd65-0297-4889-884c-2a6e5833efcc_1a6b12b8-d788-4d12-9002-ad660518bf86.html,Short-term repeated dose toxicity – systemic effects,inhalation,BMCL05,58.4 mg/m3,,rat Diboron trioxide,1303-86-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c46809a-602f-46f2-95a0-851ece07af8d/documents/d2c3bd65-0297-4889-884c-2a6e5833efcc_1a6b12b8-d788-4d12-9002-ad660518bf86.html,Chronic toxicity – systemic effects,oral,NOAEL,56.3 mg/kg bw/day,,rat Diboron trioxide,1303-86-2,"Acute oral study has been conducted with boric oxide and acute oral, dermal and inhalation studies have been performed with boric acid. Experimental data showed low acute toxicity to boric oxide and boric acid. The LD50 for boric oxide is greater than 2600 mg/kg. The mean of the male and female values were obtained from the key study (oral route; Keller 1962). The LD50 for boric acid is equivalent to 658.9 mg B/kg bw.   ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c46809a-602f-46f2-95a0-851ece07af8d/documents/3bfa9e32-a89d-4b8d-a54c-3a99ae91864a_1a6b12b8-d788-4d12-9002-ad660518bf86.html,,,,,, Diboron trioxide,1303-86-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c46809a-602f-46f2-95a0-851ece07af8d/documents/3bfa9e32-a89d-4b8d-a54c-3a99ae91864a_1a6b12b8-d788-4d12-9002-ad660518bf86.html,,oral,LD50,"2,600 mg/kg bw",no adverse effect observed, Diboron trioxide,1303-86-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c46809a-602f-46f2-95a0-851ece07af8d/documents/3bfa9e32-a89d-4b8d-a54c-3a99ae91864a_1a6b12b8-d788-4d12-9002-ad660518bf86.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Diboron trioxide,1303-86-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c46809a-602f-46f2-95a0-851ece07af8d/documents/3bfa9e32-a89d-4b8d-a54c-3a99ae91864a_1a6b12b8-d788-4d12-9002-ad660518bf86.html,,inhalation,LC50,"2,030 mg/m3",no adverse effect observed, Ammonium 2-amino-4-(hydroxymethylphosphinyl)butyrate,77182-82-2," Repeated dose toxicity, oral route of exposure Rat There are several oral repeated dose studies (of variable durations) in the rat available.   In an oral 28-day study (range-finding study for the long-term studies), Glufosinat ammonium (GA) was administered with the diet to Wistar rats at concentrations of 0, 50, 500, 2500 or 5000 ppm for 28 days. The control animals received plain diet. No deaths occurred throughout the study and no signs or symptoms of systemic toxicity were observed. Reduced bw gain was noted for males and females receiving the test substance at concentrations of 500, 2500 and 5000 ppm (not dose-related). The food consumption was slightly reduced in all animals of the 2500 and 5000 ppm group during the first week of treatment. The assessment of hematological, biochemical and urinalysis data revealed no treatment-related changes. A statistically significant increase in relative kidney weights was seen in males of the 2500 ppm group and in all treated females (not dose-related). Gross pathological examination revealed slight reddening observed in the gastric mucosa of four males of the 5000 ppm group, and several dark red areas in the gastric mucosa of one male of the 50 ppm group. These changes were possibly treatment-related. There were no microscopic changes considered to be treatment-related. Although certain parameters were affected at all dose levels, no clear dose response was observed. Due to the absence of clinical signs and microscopic pathology the NOAEL for male and female rats was set at ≥5000 ppm (534 and 557 mg/kg bw/d for males and females, respectively).   In a 90-day feeding study performed similar to OECD guideline No. 408 with minor deviations, Glufosinate-ammonium was administered by admixture with the diet to Fischer rats at concentrations of 0, 8, 64, 500 or 4000 ppm. The control animals received the diet without GA. 20 animals/sex/dose level were sacrificed at the end of the 13-week study period and then 10 animals /sex/dose level were maintained for a 4-week post-dose recovery period. One male rat fed 4000 ppm died on day 71 of administration. No treatment-related clinical signs of toxicity were seen in any dosage group. Decreased bodyweight gain was observed for males and females fed 4000 ppm through the second or third week of administration, after which bw gain was comparable to or greater than that of control animals. Decreased food consumption was observed for males and females fed 4000 ppm from the first through third week of administration. A decrease in water intake was observed for males and females of the highest dosage group during the first week of treatment. Water intake of the males fed the highest dose showed a tendency to increase from weeks 7 to 13. The ophthalmologic examinations did not show treatment-related findings. Hematological investigation revealed no changes considered to be related to GA-intake. In the serum biochemical examination, females of the 4000 ppm group showed statistically significant decreased lactate dehydrogenase (LDH) activity on day 47. This decrease was not seen in samples taken at the end of the dosing period. Other differences in the results of biochemical parameters were considered incidental and of normal biological variation. Urinalysis at the termination of administration revealed a tendency towards lower pH for both sexes administered 4000 ppm as compared to controls. This tendency was also noted in samples taken from animals late in the recovery period. The specific gravity at the termination of administration tended to increase in females of the highest dosage group. Statistically significant absolute and/or relative kidney weight increases were observed for males fed 500 ppm and up and females fed 4000 ppm. The kidney weight increases continued even after the recovery period in the 500 ppm and 4000 ppm treated males. No treatment-related macroscopic or microscopic changes were observed. The NOEL for male rats was 64 ppm (4.1 mg/kg bw/d) based on increased absolute and relative kidney weights at 500 ppm and 4000 ppm. In addition, decreased bw gain, decreased food consumption, decreased water intake and urinalysis changes were noted at 4000 ppm. The NOEL for female rats was 500 ppm (39 mg/kg bw/d). Due to the absence of clinical signs and pathological changes the NOAEL for male and female rats was set at 4000 ppm (equivalent to 263 mg/kg bw/d in males and 311 mg/kg bw/d in females).   In a second 90-day feeding study, Glufosinate-ammonium was administered by admixture with the diet to Wistar rats (10/sex/dose level) at concentrations of 0, 7500, 10000 or 20000 ppm for 13 weeks. The control animals received plain diet. A functional observational battery (modified Irwin screen test) was performed at pre-test, and at weeks 1, 2, 3, 4, 8 and 13 of treatment. 2 female animals of the highest dosage group died on day 6 or 8, respectively, of treatment. At histopathological examination, the cause of death could not be detected. However, these deaths were considered to be treatment-related. Treatment-related clinical signs were noted in both male and female animals of the 20000 ppm dosage group. The clinical symptoms noted were: sedation, lateral recumbency, hunched posture, dyspnoea, ruffled fur, emaciation, spasm (females only) and lacrimation (females only). Except for ruffled fur, which was observed until week 4 of treatment, all other signs were noted only in the first two weeks of treatment. Slight bw loss was noted for both male and female animals of the 20000 ppm dosage group during the first week of treatment. Decreased bw gain was noted for all treated animals during the first part of treatment. Thereafter the bw gain was comparable to or greater than that of control animals. Reduced food consumption was noted for all treated animals during the first part of treatment. The ophthalmologic examinations did not show treatment-related findings. Statistically significant changes observed in hematology parameters suggest a compensated erythropoietic response due to a more rapid turnover of circulating erythrocytes. The noted statistically significant changes in clinical biochemistry were considered to be of no toxicological relevance. The slight increase in the total bilirubin concentrations may be an effect related to an increased rate of free bilirubin production from circulating erythrocytes as a result of increased hemolysis. The general behavior of all treated rats during the modified Irwin screen test was statistically significantly altered in a dose-dependent manner. Animals receiving 7500 ppm showed miosis and a slight decrease in exploratory activity, alertness and/or startle response (occasionally observed, particularly in the early stages of treatment). Animals receiving 10 000 ppm showed similar signs as well as increased body tone, increased pain response and fearfulness. With the exception of week 4, the frequency of signs decreased as the study progressed. In addition, diarrhea, increased vocalization and apathy were recorded for animals of the 20 000 ppm group. In week 1, isolated animals of the 10000 and 20000 ppm groups showed rearing during which convulsive twitches and perfuse salivation were observed. The miosis, perfuse salivation, diarrhea (increased intestinal movement) and increase in body tone indicate a stimulation or overactivity of the parasympathetic nervous system. Macroscopic or microscopic examination did not reveal any abnormal treatment-related findings. In the two females, which died during the study, thymic atrophy was noted. This finding was considered to be non-specific and not treatment-related. No NOEL for male and female rats could be determined in this study. Reduced bw gain, reduced food consumption, minor changes in hematological and biochemical parameters and behavioral alterations observed in the functional observation battery were noted for all treated animals. In addition, deaths and clinical signs of toxicity were observed in animals of the highest dose group. Also, no NOAEL for male and female rats could be determined in this study, as behavioral alterations were observed for all treated animals. There are two long-term studies with GA available: a combined chronic and carcinogenicity study and a 2-year carcinogenicity study. In the first rat combined chronic and oncogenicity study, Wistar rats were exposed for 130 weeks at dose levels of 40, 140 and 500 ppm. 10 animals/sex/dose were sacrificed after 52 weeks of treatment and 20/sex/dose after 104 weeks. The remaining 50/sex/dose were assigned to the oncogenicity phase of the study and designated for sacrifice at 130 weeks for evaluation of carcinogenicity following lifetime exposure to the test substance. No treatment-related clinical signs of toxicity were observed in any dose group. Statistically significant increased bw gain was noted for males of the 2 highest dosage groups from the chronic toxicity phase of the study, and for females of the 40 and 500 ppm dosage groups from the oncogenicity phase of the study. Transient increased food consumption values were noted during the treatment period in all treated groups of the oncogenicity animals, and in treated groups of chronic toxicity males. Ophthalmologic examinations and hearing tests did not show treatment-related findings. Urinalysis data revealed no changes considered to be related to the compound administration. Hematological investigations showed statistically significant decreased hemoglobin (HB) concentration and hematocrit (HCT) values in both sexes of the highest dosage group after 52 weeks only. In addition, statistically significant decreased erythrocyte count (RBC) was noted for females of the highest dosage group after 52 weeks. Mean corpuscular haemoglobin concentration (MCHC) was statistically significant decreased for these female animals after 52, 78 and 104 weeks of treatment. The assessment of biochemical data indicated no changes of toxicological significance for standard biochemical parameters. No treatment-related macroscopic changes were noted. There were no signs of oncogenic potential of GA in this study. No NOEL for female rats was determined in this study. Changes in biochemical parameters (increased kidney GS activity) were noted for all treated females. In addition, changes in hematological parameters (decreased hemoglobin concentration, decreased hematocrit values, decreased erythrocyte count, decreased mean corpuscular hemoglobin concentrations) (500 ppm group), changes in biochemical parameters (inhibition of liver GS activity (140 and 500 ppm)), inhibition of brain GS activity (500 ppm), decreased concentrations of glutathione in the liver (140 and 500 ppm), decreased concentrations of GSH in blood (140 and 500 ppm), increased ammonia levels in urine and brain (500 ppm), and increased kidney weights (500 ppm) were noted for female rats. NOEL for male rats was 40 ppm (approximately 2 mg/kg bw/d) based on changes in biochemical parameters (inhibition of liver GS activity (140 and 500 ppm), increased kidney GS activity (140 and 500 ppm), decreased GSSG levels in the liver (140 and 500 ppm), decreased GSH levels in blood (500 ppm), increased GSSG concentrations in blood (500 ppm), changes in hematological parameters (decreased hemoglobin concentration, decreased hematocrit values) (500 ppm group), and increased kidney weights (140 and 500 ppm) noted for males rats. In the absence of clinical signs or correlative pathological changes, observed hematological and biochemical effects, and increased kidney weights were not considered to be adverse. NOAEL for male and female rats was considered to be > 500 ppm (24.4 and 28.7 mg/kg bw/d for males and females, respectively). In a second oncogenicity study performed later, rats were administered at 1000, 5000 and 10000 ppm. No treatment related mortalities or clinical signs of toxicity were observed. Statistically significant decreased bw was noted for males and females of the 5000 and 10 000 ppm groups during the first weeks of treatment. Relative food consumption was decreased in animals of the 1000, 5000 and 10 000 ppm groups during the first weeks of treatment. When compared to controls higher relative food consumption was noted for males of the 5000 and 10 000 ppm groups during weeks 3 and 4 of the study, and for females of the 10 000 ppm group during weeks 3 and 4 of the study. Higher relative food consumption was also noted for males of the 10 000 ppm groups from week 21 until the end of the study. Hematological investigations revealed no treatment-related effects on differential white cell count. Statistically significant increased weight of the kidneys was noted for all treated male and female animals. Gross pathology showed lower incidence of pituitary nodules for males in the treated groups when compared to the controls. This finding was confirmed microscopically by a statistically significant negative trend with respect to dose for pituitary adenoma of the pars distalis in males of the 5000 and 10 000 ppm groups. Microscopic evaluations showed no increase in any type of neoplasm in any dose group. Statistically significant increase in retinal atrophy characterised by partial or complete loss of the outer nuclear layer of one or both eyes was noted for males and females of the 10 000 ppm group and for females of the 5000 ppm group. In kidneys, a statistically significant decrease of multifocal corticomedullary mineralisation was noted for all treated females, and there was a statistically significant decrease in caliceal mineralisation in females of the 5000 and 10 000 ppm. No indications of any oncogenic potential of GA were observed at doses up to 10000 ppm (equivalent to 466 and 579 mg/kg bw/d for males and females, respectively). No NOEL for male and female rats was determined in this study. Increased kidney weights were noted for all treated animals. In addition, statistically significant increase in retinal atrophy was noted for females of the 5000 and 10 000 ppm groups and for males of the 10000 ppm group. Reduced bw was also noted for animals of the 5000 and 10 000 ppm groups. Two commonly occurring age-related changes in rats appear to have been reduced by treatment: the incidence of pituitary adenoma in males and mineralisation of the kidneys in females at all doses. The etiology of these effects is not known. The NOAEL was considered to be 5000 ppm (228.9 mg/kg bw/d) and 1000 ppm (57.1 mg/kg bw/d) for males and females, respectively based on the effects on the retina.   Mouse In a 13-week feeding study in mice with GA, the test substance was administered by admixture with the diet to NMRI mice (10/sex/dose level) at concentrations of 0, 80, 320 or 1280 ppm for 90 days. The control animals received the diet without the test compound. No treatment-related mortalities or clinical signs of toxicity were noted in any animal. One female animal of the lowest dosage (80 ppm) group died during blood sampling on the last test day. The mean bw gain of all treated mice was similar to that of the control group. No dose-related difference in the mean food consumption of any group was noted. Hearing tests and ophthalmologic examinations did not show treatment-related findings. Some statistical differences observed in the results of the hematological parameters were considered to be incidental and of normal biological variation. Statistically significant higher aspartate aminotransferase (ASAT/GOT) activity was noted for males of the highest dosage group. Statistically significant higher alkaline phosphatase (ALP) activity was noted for females of the highest dosage group. In addition, statistically significant increased potassium concentrations were noted for males receiving the test substance at concentrations of 320 and 1280 ppm. Statistically significant increased liver to bw ratios was noted for males of the highest dosage group. Macroscopic or microscopic examination did not reveal any abnormal treatment-related findings. The NOEL for male mice was 80 ppm (17 mg/kg bw/d) based on changes in hematological and biochemical parameters (reduced total leukocyte count (WBC) and increased potassium concentration) noted in animals fed 320 and 1280 ppm. In addition to that, higher aspartate aminotransferase (ASAT/GOT) activity and increased liver weight was noted for males of the highest dosage group. The NOEL for females was 80 ppm (19 mg/kg bw/d) based on reduced erythrocyte count (RBC) and hematocrit (HCT) noted in animals fed 320 and 1280 ppm, and changes in biochemical parameters (higher alkaline phosphatase (ALP) activity) in the highest dosage group. NOAEL for male and female mice was set at 1280 ppm (equivalent to 278 and 288 mg/kg bw/d for male and female animals, respectively). The changes in hematological and biochemical parameters in males and females, and the increased liver to bw ratio in males were considered of no toxicological significance since no correlative histopathological changes or clinical signs were observed. Further on, they were not reproduced in another 90-day toxicity study in mice conducted at higher dose levels or in a subsequent long-term toxicity study. There is a second 90-day study in mice available, where the animals were exposed to higher concentrations of Glufosinate-ammonium. GA was administered by admixture with the diet to NMRI mice (10/sex/dose level) at concentrations of 0, 1750, 3500 or 7000 ppm for 90 days. As all animals in the top dose group died within 8 days, only the low and mid dose animal terminal findings were reported (concentrations corresponded to a dose rate of 0, 274, 561 mg/kg bw/d for males, and 0, 356, 644 mg/kg bw/d for females). All animals at the highest dosage (7000 ppm) group died within 8 days of treatment. At 3500 ppm, a mortality rate of 50% was noted during the study: one male died on day 45 of treatment, the other deaths (4 males and 5 females) were observed between days 6 and 11 of treatment. At 1750 ppm, one female (10%) died on day 8 of treatment. In addition, one male of the 1750 ppm group died at scheduled necropsy after blood sampling (this death was considered to be accidentally and not test article related). Clinical signs of toxicity were noted in all dose groups. At 3500 and 7000 ppm, ruffled fur, sedation, spasm, ventral recumbency or hunched posture, dyspnoea, apathy, ataxia and emaciation were noted. At 1750 ppm, ruffled fur was evident in all animals and sedation and emaciation in some females. Bodyweight loss and reduced food consumption was noted during the first week of treatment for animals of the 1750 and 3500 ppm groups. Hematological investigations revealed no changes considered to be related to the compound administration. In the biochemical examinations, statistically significant increased alkaline phosphatase (ALP) activity was noted for males of the 3500 ppm group and statistically significant decreased potassium concentration was noted for males of the 1750 ppm and 3500 ppm groups. Statistically significant reduced mean liver weight was noted for males of the 3500 ppm group. Macroscopic or microscopic examination did not reveal any abnormal treatment-related findings. No NOEL/NOAEL was established for male and female mice in this study. Death (one female), clinical signs of toxicity, reduced bw loss, reduced food consumption and minor changes in biochemical parameters (decreased potassium concentrations in males) were noted for animals fed 1750 ppm (274 mg/kg bw/d for males, and 356 mg/kg bw/d for females). Additionally, increased alkaline phosphatase (ALP) activity and reduced mean liver weight was noted for males of the 3500 ppm group. At 3500 ppm, a mortality rate of 50% was noted during the study. At the highest dosage level (7000 ppm) all animals died. Due to the high mortality rate among the mid- and high-dose animals, the study is of limited value for hazard assessment. In a 2-year oncogenicity study in mice, Glufosinate-ammonium was administered by admixture with the diet to NMRI mice (60/sex/dose) at concentrations of 0 (controls), 20, 80 or 160 (males only) or 320 (females only) ppm. 10/sex/dose were designed for interim sacrifice after 52 weeks of treatment (chronic toxicity groups); 50/sex/dose were designed for terminal sacrifice after 104 weeks (2 years) of treatment (oncogenicity groups). Special investigations were carried out on glutathione levels in whole blood and liver tissue after 104 weeks of treatment. NOEL/NOAEL for male and NOEL for female mice was 80 ppm (equivalent to 11 and 16 mg/kg bw/d for males and females, respectively). A more detailed description of the results can be found in the IUCLID chapter for carcinogenicity.   Dog There are three repeated-dose oral toxicity studies in dogs available. In the 90-day study, Glufosinate-ammonium (GA) was administered by admixture with the diet to beagle dogs (4/sex/dose level) at concentrations of 0, 4, 8, 16, 64 or 256 ppm for 90 days. The concentrations corresponded to a dose rate of 0, 0.13, 0.26, 0.57, 2.06 and 7.98 mg/kg bw/d for males, and 0, 0.13, 0.25, 0.49, 1.97 and 7.63 mg/kg bw/d for females. A liver-function test (BSP- bromsulfophthalein method) was carried out on all dogs of the 2 high-dose groups and the control group during week 13; a kidney-function test (PSP phenolsulfonephthalein method) was conducted on the 2 high-dose groups and the control group during week 12. Electrocardiography was performed in all dogs of the control and the highest dosage group at week 13. No deaths occurred during the study. No treatment-related clinical signs of toxicity were seen in any dosage group. Statistically significant reduced bw was noted for female animals of the highest dosage group over the second half of the study. Food consumption was slightly lower for males and females of the highest dosage group. The ophthalmologic examinations did not show treatment-related findings. The assessment of hematology and urinalysis revealed no changes considered to be related to the compound administration. In the biochemical examinations, statistically significant decreased plasma inorganic phosphate levels were noted for males of the highest dosage group and for females of the 4, 16 and 64 ppm groups in week 7 only. At study termination, decreased plasma bilirubin levels were noted for males of all dose groups (statistically significant for males of the 64 and 256 ppm groups). The finding showed no dose response and was not accompanied by any changes in total-bilirubin levels and is therefore considered not to be of toxicological significance. Plasma PSP concentrations were reduced in males and females of the two high-dosage groups (statistically significant for females of the 64 ppm group only). The values of the controls (mean 1.8 males; mean 2.1 females) were relatively high as compared to historical control values with dogs of the same strain and age (according to the author historical control values range between 0.84-1.48). Since an increase rather than a decrease in PSP concentration is the reflection of impaired renal function and since no treatment related pathological changes were observed in the kidneys, it is concluded that these findings are of no toxicological significance. The mean results of the BSP-retention test were comparable for all groups and all individual data were essentially normal. There were no changes in the electrocardiograms that could be related to the feeding of the test substance. Macroscopic or microscopic examination did not reveal any abnormal treatment-related findings. No statistically significant differences in organ weights were observed between test groups and the control. The NOEL for male dogs was 64 ppm (2.06 mg/kg bw/d) based on reduced food consumption noted for males fed 256 ppm. NOEL for female dogs was 64 ppm (1.97 mg/kg bw/d) based on reduced bw and reduced food consumption noted for females fed 256 ppm. NOAEL for male and female dogs was 256 ppm (the highest dose, equivalent to 7.98 mg/kg bw/d for males and 7.63 mg/kg bw/d for females). In a 12-month oral toxicity study, Glufosinate-ammonium (GA) was administered to beagle dogs with the diet for 1 year (8/sex/dose). 4 animals/sex/dose levels were assigned for interim sacrifice after 6 months and 1 year of treatment, respectively. Electrocardiograms (ECG) of each animal were recorded at pre-test and at 6 or 12 months prior to sacrifice. The bromosulfophthalein (BSP) clearance test for measuring liver function and the phenolsulfonphthalein (PSP) clearance test for measuring kidney function were performed after 6 and 12 months of treatment. The nominal dose levels are 0, 2. 5 or 8.5 mg/kg bw/d (achieved dose levels were 0, 1.8. 4.5 or 8.4 mg/kg bw/d). In the first 10 to 17 days of the study, high dose males received the test substance in doses between 10.6 and 13.6 mg/kg bw/d, and high dose females between 15.4 and 16.0 mg/kg bw/d. Adjustments in dietary concentration were progressively made on day 11 and onwards to correct the situation. One male and one female from the highest dosage group died on days 14 and 9, respectively. The following clinical signs of toxicity were noted immediately after test article consumption in the 2 high dose animals which died and on day 9-10 for another high dose female that survived: trismus salivation and hyperactivity followed by somnolence and hypoactivity as well as stereotypic stiff gait, tremor, ataxia, whining, urinating, tonic-clonic spasm, paddling movements, opisthotonus and lateral recumbency. No other animals exhibited any unusual behavior attributed to treatment. The deaths of the animals were caused by heart and circulatory failure due to marked myocardial necrosis in one dog, and to slight myocardial necrosis and severed necrotising aspiration pneumonia in the other dog. These animals received an increased dose of the test article during the first 10-17 days of treatment. The mean bw gain of the high dose group males was reduced during the first six months of treatment, when compared with the control group. Statistically significant reduced food consumption was noted for the high dose group males during the first week of treatment. Otherwise, the mean food consumption of treated male and female dogs was comparable to that of the controls. Hearing tests and ophthalmologic examinations did not show treatment-related findings. Urinalysis data revealed no changes considered to be related to the compound administration. The assessment of hematological and clinical biochemistry data indicated no changes of toxicological significance after 1, 3, 6 and 12 months of treatment. The mean results of the PSP and BSP-clearance tests were comparable for all groups. No treatment related abnormalities in ECG parameters were noted for surviving animals. There were no changes in absolute and relative organ weights considered to be related to GA exposure. No treatment-related macroscopic or microscopic findings were noted in any of the dogs killed after 6 or 12 months of treatment. Macroscopic findings in the male that died spontaneously were increased fluid in the pericardium and subendocardial hemorrhages in the right heart. In the female that died spontaneously, the main gross findings were numerous grey-green foci in the lung; the lung was not collapsed. Microscopic findings in both dogs that died were multifocal myocardial necrosis. In addition, marked aspiration of diet material with beginning inflammatory reaction in the lungs and bronchial epithelium was noted in the female dog that died during the study. A small acute ulcer in stomach was also noted in this animal. The surviving animal of the high dose that also showed signs of neurotoxicity recovered completely. The NOAEL of the study has been set at 8.5 mg/kg bw/day (nominal), which was tolerated without any signs of intoxication. There is an additional 28-day toxicity study in beagle dogs available, which was conducted specifically in order to explore the mode of action and toxicokinetic of glufosinate-ammonium (GA). This summary focusses mainly on the toxicity endpoints. GA was administered orally (gelatine capsule) at a dose of 0, 1 or 8 mg/kg bw/day to beagle dogs (6/sex/group) for 18 days. From day 19 to 28, the animals received the radiolabelled test substance (GA-14C). The control animals received gelatine capsules containing distilled water. One dog per sex and per group was sacrificed at day 18, 19 and 28 of the treatment period and at day 1, 2 and 4 post-treatment (recovery), respectively. Animals were observed twice daily for mortality and clinical signs. Food consumption was measured daily. Body weight was recorded weekly. Eye examinations were performed pre-test and on days 14 and 25 of treatment. Males and females in all control and high dose groups were subjected to neurobehavioral assessments before dosing and on days 1, 2, 3, 4, 8, 11, 15, 18, 22 and 25. Males and females from the low dosage group were subjected to neurobehavioral assessments before dosing and on days 4, 11, 18 and 25. Blood and urine samples were taken for hematology, clinical biochemistry and urinalysis, which included measurement of catecholamines, before dosing and on days 11, 28 and 4 days post dosing. Tissues taken at necropsy were liver, heart, kidney, spinal cord, and 4 brain regions (cortex, midbrain, cerebellum and brain stem). Tissues were weighed and examined. A range of other tissues was taken at necropsy, fixed but not examined. A special biochemical examination of glutamine synthetase activity and free amino acid levels in different tissues was performed. Brain cholinesterase levels were measured in the cerebellum only. After 18 to 28 days of oral administration by capsule at 8 mg/kg/day, glufosinate ammonium induced no mortality or clinical signs, except a slight increase in gait activity in males; a lower body weight gain in the males at the end of the first week and in females during the whole study in parallel to a slight food consumption decrease. Glutamine synthetase activity and glutamine and taurine levels were also decreased at this dose level. A few changes were observed at 1 mg/kg/day but usually in only one sex and in only a few animals among each group: decrease in arginine level in female spinal cord (2 animals out of 6), in phosphoethanolamine in male cerebellum (3 animals out of 6), in glutamine in male heart without dose-effect relationship, in taurine in female cerebellum (1 animal out of 6) and female cortex. The dose of 8 mg/kg bw/day can be considered as a LOAEL with regard to the decreased glutamine synthetase activity in the brain. The dose level of 1 mg/kg bw/day can be considered as NOAEL.   Repeated dose toxicity, inhalation route of exposure Rat There are two subacute inhalation studies in the rat available. In the first study, Wistar rats (5/sex) were exposed nose-only to dust particulate aerosol atmospheres of glufosinate ammonium (GA) at concentrations of 0, 0.012, 0.025 or 0.050 mg/l air, 6 hrs/d, 5 d/week (28 exposures over 40 d). The control animals received air only. 1 day after the last exposure 10/sex/group were killed and dissected. The remaining rats were killed and dissected after a 29-day recovery period. 2 females of the highest dosage group died during the 2ndexposure, and one male of the highest dosage group died after the 2ndand another after the 17thexposure. Clinical signs observed in the rats at the highest dosage level were squatting position, staggering gait, tremors, salivation, contracted flanks, narrowed eye opening, piloerection hyperactivity, aggressiveness, tonoclonic convulsions and hematuria. Staggering gait, squatting position, tremors, hyperactivity, aggressiveness, tonoclonic convulsions and hematuria were observed in animals of the 0.025 mg/l group. There were no behavioral abnormalities in rats in any of the groups during the recovery period. Statistically significant increased bw gain was noted for males and females of the highest dosage group, and for females in the 0.025 mg/l group. Slight increased food consumption was noted for males and females of the highest dosage group. Relative water consumption was increased during periods of the study for males and females of the 2 highest dosage groups. Hematological investigations and biochemical examinations revealed no changes considered to be related to the compound administration. The few statistically significant changes observed were within the range of normal biological variability for the strain of the test species and in many cases nonconcentration-related. There were no changes in relative organ weights considered to be related to the compound administration. No treatment-related macroscopic or microscopic findings were noted in any of the rats surviving the duration of the study. One male that died showed aspiration pneumonia. The other 3 animals that died showed cell atrophy in thymus and bone marrow and contraction of the spleen. In addition, blood congestion and focal or single hyperkeratosis in the fore-stomach was noted in two of these animals. NOEL/NOAEL for male and female rats was 0.012 mg/l air based on clinical signs of toxicity (neurotoxic symptoms) and increased bw gain (females only) noted in animals receiving 0.025 mg/l air. In addition to that, mortalities and increased food consumption were noted in animals of the highest (0.05 mg/l air) dosage group. During a second 28-day inhalation study in CD rats, the systemic toxic potential of technical liquid Glufosinate ammonium (50% aqueous solution) to rats by nose-only inhalation administration for 6 hours a day, 5 days a week, was assessed over a period of 4 weeks. Two groups, each comprising five male and five female rats received Glufosinate ammonium at target levels of 0.05 or 0.1 mg GA/L. These concentrations are equivalent to 0.109 and 0.205 mg/L of the technical liquid, respectively. A similarly constituted Control group was exposed to clean air only. During the study, clinical condition, detailed physical examination, bodyweight, food consumption, ophthalmic examination, hematology, blood chemistry, organ weight, and macropathology investigations were undertaken. A Group 3 female rat was sacrificed on humane grounds on Day 3 of the study due to adverse clinical signs including piloerection, unsteady gait, partially closed eyelids, hunched posture and pallor. There were no treatment related clinical signs observed in male animals exposed at 0.109 mg/L. In females exposed at 0.109 mg/L there were occasional incidences of aggression, salivation and vocalisation in one animal; underactivity and hunched posture in a second animal; and repetitive head movements in a third. In view of the low incidence and transient nature of these signs and their absence in males, these observations are considered treatment-related but not adverse. Treatment related clinical signs were observed in all animals given 0.205 mg/L, including irritable, nervous and underactive behaviour. Repetitive movements of the head were seen intermittently in a proportion of male and female animals. Male rats were observed to have several bite marks following 2 exposures to the test compound and these animals were housed singly from Day 3 of exposures. These clinical signs represent a clear response to treatment at this dose. There were no treatment-related effects on bodyweight gain, food consumption or ophthalmic findings considered to be attributed to the administration of Glufosinate ammonium. A dose related reduction in mean urea levels in all treated groups was seen in Week 4, but this was only statistically significant for females in Group 3. Increased kidney weights were seen in treated males receiving 0.109 and 0.205 mg/L. The no observed adverse effect level (NOAEL) was considered to be 0.109 mg/L of the technical liquid (corresponding to 0.05 mg GA/L) but, due to the minor transient clinical signs seen at this level a no observed effect level (NOEL) could not be established. Considering toxicity after repeated inhalation exposure to GA , the 28-day study with the technical liquid is regarded as key study, as GA is only handled in aqueous solution. This is reflected in the legal classification (CLP Annex VI), concluded on by the ECB in 2007. All the data on repeated dose toxicity available in this REACh dossier has been available to ECB for their classification decision.   Repeated dose toxicity, dermal route of exposure Rat Wistar rats (6/sex/group) were dermally exposed to glufosinate-ammonium (GA) for 6 hrs/d, 5 d/week (21 applications over 30 d) at dose levels of 0, 100, 300 or 1000 mg/kg bw/d. The control animals received the vehicle only. Additionally, 5 animals/sex/group were treated by a similar regimen at dose levels of 0 or 1000 mg/kg bw/d followed by a 14-d recovery period. No deaths occurred during the study. One male animal of the highest dosage group refused its food almost entirely from the beginning of the second week of treatment and had to be removed from the study in a cachectic condition on day 16; encrusted blood was also observed around the eyes and the mouth/nose of this animal. Clinical signs observed in rats at the highest dosage level were timid or aggressive behavior, increased motor excitation, piloerection or squatting position. One male animal of the 300 mg/kg bw group showed aggressive behavior, squatting position, piloerection and convulsive jumping and rolling spasms at the end of the treatment period. No dermal irritation was noted in any group. Bw gain, food- and water consumption data showed no substance-related changes in any of the dose groups. Hematological examinations and urinalysis revealed no changes considered to be related to the compound administration. Biochemical examinations showed a statistically significant increase in uric acid in the serum in the males of the 300 and 1000 mg/kg bw groups. There were no changes in absolute or relative organ weights considered to be related to GA-exposure. Macroscopic or microscopic examinations did not reveal any abnormal GA-related findings. The male animal of the highest dosage group, which was killed in a moribund condition on day 16, showed contracted spleen. NOEL/NOAEL for male rats was 100 mg/kg bw/d based on clinical signs of toxicity (neurotoxic symptoms) and minor changes in biochemical parameters (increase in uric acid in the serum) noted in male animals of the 300 and 1000 mg/kg bw/d groups. NOEL/NOAEL for female rats was 300 mg/kg bw/d based on clinical signs of toxicity (neurotoxic symptoms) noted in female animals of the 1000 mg/kg bw/d groups. Summary In conclusion, the main treatment-related findings observed after glufosinate ammonium administration through oral, inhalation or dermal routes, are neurological signs. The most sensitive species is dog, followed by mouse (oral route of exposure). ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/817f4f05-0bc9-4e19-b528-3f4f7d88d824/documents/8b98a6d3-b041-484c-891a-c70f1ca383fe_8228a1b8-dfbc-4cbe-ae76-5047082385b8.html,,,,,, Ammonium 2-amino-4-(hydroxymethylphosphinyl)butyrate,77182-82-2," After acute oral administration by gavage, the rat is the less sensitive species with an LD50 between 1500 to 2000 mg/kg bw. The acute oral LD50 in mice is between 416 to 460 mg/kg bw and a dose of 400 mg/kg bw killed both dogs whereas no mortality was observed at 200 mg/kg bw. In rodents deaths were noted up to 8 days after administration. The major clinical signs were neurological effects such as decreased motility, uncoordinated gait, hunched posture, piloerection, exophthalmus, convulsions, diarrhea. Mice exposed to glufosinate ammonium through the dietary route showed mortality starting at 300 mg/kg bw.The calculated LD50 values are consistent between two different mouse strains and lie between 416 and 464 mg/kg bw. Clinical signs including clonic convulsions, abdominal position, squatting, uncoordinated gait, piloerection, poor general condition. Surviving animals showed recovery from day 2 or at the latest day 6, depending on dose, severity and strain.    Table 1: acute oral toxicity data Species  Strain  Sex  LD50 (mg/kg bw)  Mouse  NMRI  Female  416  Male  431  ICR  Female  464  Male  436  Rat  F344  Female  1510  Male  1660  Wistar  Female  1620  Male  2000  Dog  Beagle  Male/Female  200 - 400    Neurological effects were also observed after dermal application. The clinical signs observed in rats include hyperactivity or passiveness, convulsions or convulsive jumping, disequilibrium, squatting, high legged posture, retracted abdomen or flanks, increased salivation and aggressivity. In rabbits, pilo-erection, unsteady gait, lethargy and ataxia were observed.The LD50 was above 4000 mg/kg bw in rats, above 2000 mg/kg bw in male rabbits and between 1500and 2000 mg/kg bw in female rabbits.   Table 2: acute dermal toxicity data Species  Strain  Sex  LD50 (mg/kg bw)  Rabbit  New Zealand White  Male/Female  2000  Rat  Wistar  Male  > 4000  Female  > 4000      The LC50 obtained in rats after acute exposure via inhalation was 1.26 mg/L in males and 2.60 mg/L in females. The deaths occurred between days 4 and 9 after inhalation. The major clinical signs were narrowed eye openings, periodic tremors and clonic convulsions, hyperactivity, piloerection, increased salivation and passivity.   Table 3: acute inhalation toxicity data Species  Strain  Sex  LD50 (mg/L)  Rat  Wistar  Male  1.26  Female  2.6      ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/817f4f05-0bc9-4e19-b528-3f4f7d88d824/documents/a59038dd-bc07-4bfc-b845-b6b576ae98e1_8228a1b8-dfbc-4cbe-ae76-5047082385b8.html,,,,,, Ammonium 2-amino-4-(hydroxymethylphosphinyl)butyrate,77182-82-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/817f4f05-0bc9-4e19-b528-3f4f7d88d824/documents/a59038dd-bc07-4bfc-b845-b6b576ae98e1_8228a1b8-dfbc-4cbe-ae76-5047082385b8.html,,oral,LD50,416 mg/kg bw,adverse effect observed, Ammonium 2-amino-4-(hydroxymethylphosphinyl)butyrate,77182-82-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/817f4f05-0bc9-4e19-b528-3f4f7d88d824/documents/a59038dd-bc07-4bfc-b845-b6b576ae98e1_8228a1b8-dfbc-4cbe-ae76-5047082385b8.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, Ammonium 2-amino-4-(hydroxymethylphosphinyl)butyrate,77182-82-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/817f4f05-0bc9-4e19-b528-3f4f7d88d824/documents/a59038dd-bc07-4bfc-b845-b6b576ae98e1_8228a1b8-dfbc-4cbe-ae76-5047082385b8.html,,inhalation,LC50,"1,260 mg/m3",adverse effect observed, Nickel dichloride,7718-54-9," Value used for CSA (read-across from Nickel sulphate): NOAEL (oral, systemic, animal): 10 mg Ni sulphate hexahydrate /kg bw/day (or 2.2 mg Ni/kg bw/day) (Heim et al. 2007) NOAEC (inhalation, local, animal): 0.12 mg Ni sulphate hexahydrate /m³ air ( or 0.027 mg Ni/m3 air) (Dunnick et al., 1995) LOAEC(inhalation, local, animal): 0.25 mg nickel sulphate hexahydrate/m3 (or 0.056 mg Ni/m3) (Dunnick et al., 1995) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bb55c7c-9100-4762-a76a-6acebfad04a6/documents/9d4cea0a-e9ef-4638-b5cb-a04901eb834e_f18e0f39-7d76-42d7-8baf-172f44f58275.html,,,,,, Nickel dichloride,7718-54-9," Values used for CSA: NOAEL (oral, systemic, animal): 100 mg NiCl2.6H2O/kg bw(or 22 mg Ni/kg bw/day) (FDRL, 1983) LOAEL (oral, systemic, human data; read-across): 0.012 mg Ni (Ni ion)/kg bw/day released from metallic nickel in water and food contact material (Nielsen et al 1999) NOAEC (inhalation, systemic, animal): 0.054 mg NiCl2.6H2O/L air (13.33 mg Ni/m3) (PSL, 2014/2015) - mortality ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bb55c7c-9100-4762-a76a-6acebfad04a6/documents/71503952-27da-4f34-8c73-fd711baa417e_f18e0f39-7d76-42d7-8baf-172f44f58275.html,,,,,, "Matte, nickel",69012-50-6,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in endpoint summaries for each consitutent in Section 7. ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4fc0054-61a0-4fdd-8937-d33a935cb297/documents/IUC5-b5c12e45-35cf-461c-b5b5-c8feb7373950_7d57a209-1185-4f7d-b89b-503355353d3d.html,,,,,, "Matte, nickel",69012-50-6,"The acute oral LD50 of three Ni matte samples has been shown to be greater than 5,000 mg/kg bw (EPSL, 2009a-c). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4fc0054-61a0-4fdd-8937-d33a935cb297/documents/IUC5-22ef5bf0-867c-43d3-b7c1-5c7fcc13d177_7d57a209-1185-4f7d-b89b-503355353d3d.html,,,,,, tert-butyl hydroperoxide,75-91-2,"Toxicokinetic data demonstrate very low or absent systemic bioavailability. This is consistent with results from a key, GLP compliant guideline screening study which found no systemic effects following repeated oral exposure. Results from a key GLP compliant guideline sub-chronic (90-d) inhalation study identify a NOAEC (threshold) for hyperplasia in nasal tissue. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9437605-e8a5-40f9-8ab6-793a56a4bb0a/documents/IUC5-8351b1ba-2cc7-4232-9917-ca884eb96b1c_68b2e400-9394-4eee-ab71-cc3fbdd4741e.html,,,,,, tert-butyl hydroperoxide,75-91-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9437605-e8a5-40f9-8ab6-793a56a4bb0a/documents/IUC5-8351b1ba-2cc7-4232-9917-ca884eb96b1c_68b2e400-9394-4eee-ab71-cc3fbdd4741e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,22.2 mg/m3,adverse effect observed,rat tert-butyl hydroperoxide,75-91-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable GLP study available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Reliable GLP studies are available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Reliable GLP studies are available ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9437605-e8a5-40f9-8ab6-793a56a4bb0a/documents/IUC5-b05e0133-7795-43c3-b9a4-a3be28701cf9_68b2e400-9394-4eee-ab71-cc3fbdd4741e.html,,,,,, tert-butyl hydroperoxide,75-91-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9437605-e8a5-40f9-8ab6-793a56a4bb0a/documents/IUC5-b05e0133-7795-43c3-b9a4-a3be28701cf9_68b2e400-9394-4eee-ab71-cc3fbdd4741e.html,,oral,LD50,560 mg/kg bw,adverse effect observed, tert-butyl hydroperoxide,75-91-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9437605-e8a5-40f9-8ab6-793a56a4bb0a/documents/IUC5-b05e0133-7795-43c3-b9a4-a3be28701cf9_68b2e400-9394-4eee-ab71-cc3fbdd4741e.html,,dermal,LD50,440 mg/kg bw,adverse effect observed, tert-butyl hydroperoxide,75-91-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9437605-e8a5-40f9-8ab6-793a56a4bb0a/documents/IUC5-b05e0133-7795-43c3-b9a4-a3be28701cf9_68b2e400-9394-4eee-ab71-cc3fbdd4741e.html,,inhalation,LC50,"1,843 mg/m3",adverse effect observed, Hydroxylammonium nitrate,13465-08-2,All the studies located indicated similar signs of toxicity after repeated administration of hydroxylammonium nitrate or an analogue namely: methaemaglobinaemia and haemolytic anaemia with compensatory extramedullary haematopoiesis primarily in the spleen but also observed in other organs such as the bone marrow and liver. A NOAEL of 0.2 mg/kg bw/day was determined in rats after administration of hydroxylammonium sulphate via their drinking water and a LOAEL of 0.7 mg/kg in rabbits after sub acute dermal application of hydroxylammonium nitrate. ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d1f9d23-b727-41e2-9120-1f16cbe9e6a8/documents/IUC5-a713fd70-8599-4b81-a563-a984bf381210_f0887260-0002-41df-9452-71d92eafd7ed.html,,,,,, Hydroxylammonium nitrate,13465-08-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d1f9d23-b727-41e2-9120-1f16cbe9e6a8/documents/IUC5-a713fd70-8599-4b81-a563-a984bf381210_f0887260-0002-41df-9452-71d92eafd7ed.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,0.7 ,,rabbit Hydroxylammonium nitrate,13465-08-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d1f9d23-b727-41e2-9120-1f16cbe9e6a8/documents/IUC5-a713fd70-8599-4b81-a563-a984bf381210_f0887260-0002-41df-9452-71d92eafd7ed.html,Chronic toxicity – systemic effects,oral,NOAEL,0.2 mg/kg bw/day,,rat Hydroxylammonium nitrate,13465-08-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d1f9d23-b727-41e2-9120-1f16cbe9e6a8/documents/IUC5-a713fd70-8599-4b81-a563-a984bf381210_f0887260-0002-41df-9452-71d92eafd7ed.html,Repeated dose toxicity – local effects,dermal,LOAEL,0.7 ,adverse effect observed,rabbit Hydroxylammonium nitrate,13465-08-2,An acute oral LD50 of 300 - 400 mg/kg bw in rats was determined for hydroxylammonium sulphate. The studies all indicate that animals displayed cyanosis and methaemoglobinaemia. No data on the acute inhalation toxicity of hydroxylammonium nitrate or analogues were located. An acute dermal LD50 of 70 mg/kg bw was identified for hydroxylammonium nitrate in rabbits. An acute dermal LOAEL of 10 mg/kg bw of hydroxylammonium sulphate was determined in the rat and rabbit based on methaemoglobinaemia. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d1f9d23-b727-41e2-9120-1f16cbe9e6a8/documents/IUC5-bb8c94e9-d18a-4185-a469-27175422bd54_f0887260-0002-41df-9452-71d92eafd7ed.html,,,,,, Hydroxylammonium nitrate,13465-08-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d1f9d23-b727-41e2-9120-1f16cbe9e6a8/documents/IUC5-bb8c94e9-d18a-4185-a469-27175422bd54_f0887260-0002-41df-9452-71d92eafd7ed.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Hydroxylammonium nitrate,13465-08-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d1f9d23-b727-41e2-9120-1f16cbe9e6a8/documents/IUC5-bb8c94e9-d18a-4185-a469-27175422bd54_f0887260-0002-41df-9452-71d92eafd7ed.html,,dermal,LD50,70 mg/kg bw,adverse effect observed, "Distillates (petroleum), vacuum",70592-78-8," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4250ee3-d724-4922-833b-63b27d18911c/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_82c58ab2-b164-4c76-9137-690a4e6ec20d.html,,,,,, "Distillates (petroleum), vacuum",70592-78-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4250ee3-d724-4922-833b-63b27d18911c/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_82c58ab2-b164-4c76-9137-690a4e6ec20d.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Distillates (petroleum), vacuum",70592-78-8,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4250ee3-d724-4922-833b-63b27d18911c/documents/12190120-6b6e-49c5-bed7-264eab246437_82c58ab2-b164-4c76-9137-690a4e6ec20d.html,,,,,, "Distillates (petroleum), vacuum",70592-78-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4250ee3-d724-4922-833b-63b27d18911c/documents/12190120-6b6e-49c5-bed7-264eab246437_82c58ab2-b164-4c76-9137-690a4e6ec20d.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Distillates (petroleum), vacuum",70592-78-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4250ee3-d724-4922-833b-63b27d18911c/documents/12190120-6b6e-49c5-bed7-264eab246437_82c58ab2-b164-4c76-9137-690a4e6ec20d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), vacuum",70592-78-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4250ee3-d724-4922-833b-63b27d18911c/documents/12190120-6b6e-49c5-bed7-264eab246437_82c58ab2-b164-4c76-9137-690a4e6ec20d.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, Cobalt carbonate,513-79-1,"Acute oral toxicity:LD50 (male and female rats)= 697 mg cobalt carbonate/kg (Confidence interval: 575 - 854 mg/kg)Acute dermal toxicity:Conduct of an acute dermal toxicity study for cobalt carbonate is unjustified since dermal uptake is considered negligible.Acute inhalation toxicity:LC50 (male and female rats, 4 hours) > 5.08 mg/L air ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05b4f749-af77-42c2-83f5-20ee3b2aa2ad/documents/IUC5-e98efdf1-e16a-48c0-8a73-40d44c975abd_c95e6134-90f3-408b-b517-2690f67ceb82.html,,,,,, Cobalt carbonate,513-79-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05b4f749-af77-42c2-83f5-20ee3b2aa2ad/documents/IUC5-e98efdf1-e16a-48c0-8a73-40d44c975abd_c95e6134-90f3-408b-b517-2690f67ceb82.html,,oral,LD50,697 mg/kg bw,adverse effect observed, Cobalt carbonate,513-79-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05b4f749-af77-42c2-83f5-20ee3b2aa2ad/documents/IUC5-e98efdf1-e16a-48c0-8a73-40d44c975abd_c95e6134-90f3-408b-b517-2690f67ceb82.html,,inhalation,LC50,"5,080 mg/m3",no adverse effect observed, "1,2-dichloropropane",78-87-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bc0076d-c19a-4768-872f-b283b9b22019/documents/IUC5-7a52cc6a-d47e-4642-9efa-008c713759fa_047796f5-bd42-4dac-b107-bb487a0669b4.html,Chronic toxicity – systemic effects,oral,NOAEL,62 mg/kg bw/day,,rat "1,2-dichloropropane",78-87-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bc0076d-c19a-4768-872f-b283b9b22019/documents/IUC5-4dc6cbc1-6134-4eb5-947e-08db16223cb7_047796f5-bd42-4dac-b107-bb487a0669b4.html,,oral,LD50,"2,200 mg/kg bw",, "1,2-dichloropropane",78-87-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bc0076d-c19a-4768-872f-b283b9b22019/documents/IUC5-4dc6cbc1-6134-4eb5-947e-08db16223cb7_047796f5-bd42-4dac-b107-bb487a0669b4.html,,dermal,LD50,"10,100 mg/kg bw",, "Aromatic hydrocarbons, C8, catalytic reforming-derived",91995-18-5,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdb97518-954f-4594-88bb-3a79b22d4ebc/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_aed6c27f-9523-42d6-b62a-8885b9fe1d5a.html,,,,,, "Aromatic hydrocarbons, C8, catalytic reforming-derived",91995-18-5,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdb97518-954f-4594-88bb-3a79b22d4ebc/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_aed6c27f-9523-42d6-b62a-8885b9fe1d5a.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Aromatic hydrocarbons, C8, catalytic reforming-derived",91995-18-5,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdb97518-954f-4594-88bb-3a79b22d4ebc/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_aed6c27f-9523-42d6-b62a-8885b9fe1d5a.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Aromatic hydrocarbons, C8, catalytic reforming-derived",91995-18-5," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdb97518-954f-4594-88bb-3a79b22d4ebc/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_aed6c27f-9523-42d6-b62a-8885b9fe1d5a.html,,,,,, "Aromatic hydrocarbons, C8, catalytic reforming-derived",91995-18-5,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdb97518-954f-4594-88bb-3a79b22d4ebc/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_aed6c27f-9523-42d6-b62a-8885b9fe1d5a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Aromatic hydrocarbons, C8, catalytic reforming-derived",91995-18-5,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdb97518-954f-4594-88bb-3a79b22d4ebc/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_aed6c27f-9523-42d6-b62a-8885b9fe1d5a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aromatic hydrocarbons, C8, catalytic reforming-derived",91995-18-5,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdb97518-954f-4594-88bb-3a79b22d4ebc/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_aed6c27f-9523-42d6-b62a-8885b9fe1d5a.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Gas oils (petroleum), heavy atmospheric",68783-08-4," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92a0f9d4-20e5-4be3-ab33-41c24279f5f5/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_19adf53c-fe4c-4bfd-bfba-a3ce3f56abde.html,,,,,, "Gas oils (petroleum), heavy atmospheric",68783-08-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92a0f9d4-20e5-4be3-ab33-41c24279f5f5/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_19adf53c-fe4c-4bfd-bfba-a3ce3f56abde.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Gas oils (petroleum), heavy atmospheric",68783-08-4,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92a0f9d4-20e5-4be3-ab33-41c24279f5f5/documents/12190120-6b6e-49c5-bed7-264eab246437_19adf53c-fe4c-4bfd-bfba-a3ce3f56abde.html,,,,,, "Gas oils (petroleum), heavy atmospheric",68783-08-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92a0f9d4-20e5-4be3-ab33-41c24279f5f5/documents/12190120-6b6e-49c5-bed7-264eab246437_19adf53c-fe4c-4bfd-bfba-a3ce3f56abde.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), heavy atmospheric",68783-08-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92a0f9d4-20e5-4be3-ab33-41c24279f5f5/documents/12190120-6b6e-49c5-bed7-264eab246437_19adf53c-fe4c-4bfd-bfba-a3ce3f56abde.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), heavy atmospheric",68783-08-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92a0f9d4-20e5-4be3-ab33-41c24279f5f5/documents/12190120-6b6e-49c5-bed7-264eab246437_19adf53c-fe4c-4bfd-bfba-a3ce3f56abde.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, Bromine,7726-95-6,"Bromine is a highly reactive substance which is well known to cause burns to skin and eyes. It is classified/labelled for skin corrosion 1A (H314) and acute inhalation toxicity (H330). There is sufficient human data available to indicate an appropriate level for hazard identification for the main route of possible exposure, inhalation. The available data has been used for indication of an EU Indicative Occupational Exposure Level value (IOELV) given in Directive 2006/15/EC (8hr IOELV = 0.7 mg/m3 or 0.1 ppm). ECHA Guidance states that an EU IOELV can be used in place of a derived DNEL. Additional routes of exposure (i.e. oral or dermal) are not considered as appropriate routes for determination of repeat dose toxicity.With regard to systemic effects, due to the rapid reactivity in water (see above), the moiety of concern for systemic toxicity after bromine exposure is the bromide ion.Therefore sodium and ammonium bromide data on repeated dose toxicity were included in this dossier as supporting information for the weight of evidence approach. The relevant NOAEL for repeated dose toxicity was from a 90-day oral study in rats was 95 mg/kg bw/day. Such internal doses could never be reached by exposure to Bromine because of its corrosive properties.Due to the irritant and corrosive properties of bromine and the HOBr/OBr reaction products these properties are considered the lead effect. It is unlikely then that at concentrations below the irritation threshold absorbed bromide levels would reach toxic concentrations. For example, the lowest DNEL derived for workers in the registration dossier of sodium bromide corresponds to 3.65 mg/m3 of bromide and is considerably higher than the DNEL of 0.7 mg/m3derived forlocal irritation effects of bromine.The assessment is based on human data and a weight of evidence approach. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a52f952e-99aa-437b-bd7f-ce554abd62a2/documents/IUC5-a157e08d-c6c7-4d41-8716-966d6b042041_b1eef9d3-6538-4823-92c4-13c4a23fe9e0.html,,,,,, Bromine,7726-95-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a52f952e-99aa-437b-bd7f-ce554abd62a2/documents/IUC5-a157e08d-c6c7-4d41-8716-966d6b042041_b1eef9d3-6538-4823-92c4-13c4a23fe9e0.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,1.4 mg/m3,,other:human Bromine,7726-95-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a52f952e-99aa-437b-bd7f-ce554abd62a2/documents/IUC5-a157e08d-c6c7-4d41-8716-966d6b042041_b1eef9d3-6538-4823-92c4-13c4a23fe9e0.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1.4 mg/m3,adverse effect observed,other:human Bromine,7726-95-6,"Bromine is a highly reactive substance which is well known to cause burns to skin and eyes. It is classified/labelled for skin corrosion 1A (H314) and acute inhalation toxicity (H330). Acute inhalation studies in animals have been submitted (Annex VIII Section 8.5.2) in support of the existing classification. Therefore in accordance with the conditions outlined under the column 2 adaptation for this endpoint, it is not necessary to conduct the acute oral or dermal toxicity tests.In an acute inhalation exposure study in male albino mice, mortalities and time to death were measured for bromine as well as for chlorine, formaldehyde and sulfur dioxide. For bromine at a constant concentration, time of death depended markedly on exposure duration. The LT50 value for 750 ppm was 9 minutes, and for 240 ppm was 100 minutes. Median time of death at the LT50 value was 11 and 6 days, respectively.The study by Bitron and Aharonson (1978) was considered by Oak Ridge National Laboratory to provide sufficient data for the derivation of the relationship between concentrations that resulted in lethality (LC50 values) and exposure duration that could be expressed as: C2.2x t = k. Based on the data, and using the relationship expressed, Oak Ridge National Laboratory calculated an overall LC50 value for this study to be 424 ppm for a 30 minute exposure.Schlagbauer and Henschler (1967) found inhalation of bromine by groups of female NMRI mice led to severe irritation and corrosion of the respiratory tract. Death occurred through lung edema and bronchospasm secondary to the irritation. A 30 min LC50 of 174 ppm was derived. No mortality occurred after 3 hours of exposure to 22 ppm of bromine, while 7/10 animals died after exposure to 22 ppm of bromine for 6 hours. 40 ppm of bromine inhaled for 3 hours led to mortality of 3/10 animals, while 9/10 animals died after exposure to the same concentration for 6 hours. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a52f952e-99aa-437b-bd7f-ce554abd62a2/documents/IUC5-f7716856-41aa-4994-904d-2f966424644d_b1eef9d3-6538-4823-92c4-13c4a23fe9e0.html,,,,,, Bromine,7726-95-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a52f952e-99aa-437b-bd7f-ce554abd62a2/documents/IUC5-f7716856-41aa-4994-904d-2f966424644d_b1eef9d3-6538-4823-92c4-13c4a23fe9e0.html,,inhalation,discriminating conc.,0.7 mg/m3,, "thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine",153719-23-4," Oral, sub-chronic (OECD 408, rats): NOAEL = 250 ppm (males) and 1250 ppm (females), equivalent to dose levels of 17.6 mg/kg bw/day (males) and 92.5 mg/kg bw/day (females) Oral, chronic (OECD 452, dogs): NOAEL = 150 ppm (males and females), equivalent to dose levels of 4.05 mg/kg bw/day (males) and 4.49 mg/kg bw/day (females) Dermal, sub-chronic (OECD 410, rats): NOAEL = 250 mg/kg bw/day (males) and 60 mg/kg bw/day (females), no local effects were observed All available data were assessed and the studies representing the worst-case effects were included as key or weight-of-evidence studies. Other studies are included as supporting information. The key studies are considered to be worst-case and were selected for the CSA. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c59e985e-b4cb-487a-acd0-5a866ec5dddd/documents/8e449e47-272b-4417-bfda-38ea568ab55d_345b90c7-6d77-4bd5-9571-c269840abb58.html,,,,,, "thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine",153719-23-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c59e985e-b4cb-487a-acd0-5a866ec5dddd/documents/8e449e47-272b-4417-bfda-38ea568ab55d_345b90c7-6d77-4bd5-9571-c269840abb58.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,60 mg/kg bw/day,,rat "thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine",153719-23-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c59e985e-b4cb-487a-acd0-5a866ec5dddd/documents/8e449e47-272b-4417-bfda-38ea568ab55d_345b90c7-6d77-4bd5-9571-c269840abb58.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17.6 mg/kg bw/day,,rat "thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine",153719-23-4," - Oral: LD50 = 1536 mg/kg bw (95% 1267 - 1905 mg/kg bw), male/female, rat; equivalent to OECD 401, Oda 1996 - Inhalation: LC50 (4h) ≥3.72 mg/L, male/female, rat, OECD 403, Shutoh 1996 - Dermal: LD50 > 2000 mg/kg bw; male/female, rat, OECD 402, Oda 1996 ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c59e985e-b4cb-487a-acd0-5a866ec5dddd/documents/d01d8eb8-b424-4e2f-9ddb-97098494fd71_345b90c7-6d77-4bd5-9571-c269840abb58.html,,,,,, "thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine",153719-23-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c59e985e-b4cb-487a-acd0-5a866ec5dddd/documents/d01d8eb8-b424-4e2f-9ddb-97098494fd71_345b90c7-6d77-4bd5-9571-c269840abb58.html,,oral,LD50,"1,563 mg/kg bw",adverse effect observed, "thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine",153719-23-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c59e985e-b4cb-487a-acd0-5a866ec5dddd/documents/d01d8eb8-b424-4e2f-9ddb-97098494fd71_345b90c7-6d77-4bd5-9571-c269840abb58.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "thiamethoxam (ISO); 3-(2-chloro-thiazol-5-ylmethyl)-5-methyl[1,3,5]oxadiazinan-4-ylidene-N-nitroamine",153719-23-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c59e985e-b4cb-487a-acd0-5a866ec5dddd/documents/d01d8eb8-b424-4e2f-9ddb-97098494fd71_345b90c7-6d77-4bd5-9571-c269840abb58.html,,inhalation,discriminating conc.,"3,730 mg/m3",no adverse effect observed, 3-methylpyrazole,1453-58-3," For repeated dose toxicity following study results are available for 3-Methylpyrazole: 1. 28-day sub-acute oral toxixity in mice: No NOAEL was identified based on adverse effects in the lung 2. 90-day sub-chronic oral toxicity in rats: NOAEL: 40 mg/kg 3. 90-day sub-chronic oral toxicity in mice: NOAEL: female: 5.31 mg/kg, male: 5.2 mg/kg 4. chronic toxicity (18 month) in rats: NAEL: 0.7 mg/kg based on liver alterations 5. Supporting: 90-day sub-chronic oral toxicity in rats: NOEL: 2 mg/kg 6. Supporting: 4-weeks lung toxicity study in mice: lung toxicity observed at all concentrations tested (900, 1125, 1575 ppm drinking water) 7. 2-week palatability study in mice: no effects observed at all concentrations tested (225, 675 ppm drinking water) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75ff397b-02ff-4953-9ca8-40c891aa6fb0/documents/IUC5-4e4d8b66-2ad5-4f3f-9876-c11041011011_60e14c02-a24b-45ed-b2eb-91c6ab46040c.html,,,,,, 3-methylpyrazole,1453-58-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75ff397b-02ff-4953-9ca8-40c891aa6fb0/documents/IUC5-4e4d8b66-2ad5-4f3f-9876-c11041011011_60e14c02-a24b-45ed-b2eb-91c6ab46040c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat 3-methylpyrazole,1453-58-3, The acute oral toxicity of 3-Methylpyrazole is greater than 300 and smaller than 2000 mg/kg. The acute inhalation LC50 for 3-Methylpyrazole is greater than 28000 mg/cm3 (highest technically achievable concentration). ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75ff397b-02ff-4953-9ca8-40c891aa6fb0/documents/IUC5-e4bf378a-5bc2-401b-8d7f-9cf668381fa1_60e14c02-a24b-45ed-b2eb-91c6ab46040c.html,,,,,, 3-methylpyrazole,1453-58-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75ff397b-02ff-4953-9ca8-40c891aa6fb0/documents/IUC5-e4bf378a-5bc2-401b-8d7f-9cf668381fa1_60e14c02-a24b-45ed-b2eb-91c6ab46040c.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, 3-methylpyrazole,1453-58-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75ff397b-02ff-4953-9ca8-40c891aa6fb0/documents/IUC5-e4bf378a-5bc2-401b-8d7f-9cf668381fa1_60e14c02-a24b-45ed-b2eb-91c6ab46040c.html,,inhalation,LC50,"28,000 mg/m3",no adverse effect observed, "3,3'-dichlorobenzidine dihydrochloride",612-83-9,After single oral application of > 2000 mg/kg bw to female rats no lethality was observed. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fe72913-00eb-4955-946d-84b44caeb4b3/documents/IUC5-33bc311d-e55c-4107-a30e-33738ed563bc_c84406da-2a39-480c-8545-5ab1b6f18030.html,,,,,, "2-[(3-aziridin-1-ylpropionyl)methyl]-2-ethylpropane-1,3-diyl bis(aziridine-1-propionate)",52234-82-9," Acute toxicity oral: LD50 = approx. 5697 mg/kg body weight; read-across Acute toxicity inhalation (similar to OECD TG 403): LC50 < 1 mg/L air, only nominal concentration determined Acute toxicity dermal (similar to OECD TG 402): LD50 > 3000 mg/kg body weight ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7feab210-71b4-49a8-9915-d4023fe96d7d/documents/7a5157d4-77a0-4e34-a11d-589ec9107984_76de1279-e639-4e4a-9c63-9652cd2acbbd.html,,,,,, "2-[(3-aziridin-1-ylpropionyl)methyl]-2-ethylpropane-1,3-diyl bis(aziridine-1-propionate)",52234-82-9,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7feab210-71b4-49a8-9915-d4023fe96d7d/documents/7a5157d4-77a0-4e34-a11d-589ec9107984_76de1279-e639-4e4a-9c63-9652cd2acbbd.html,,oral,LD50,"5,697 mg/kg bw",adverse effect observed, "2-[(3-aziridin-1-ylpropionyl)methyl]-2-ethylpropane-1,3-diyl bis(aziridine-1-propionate)",52234-82-9,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7feab210-71b4-49a8-9915-d4023fe96d7d/documents/7a5157d4-77a0-4e34-a11d-589ec9107984_76de1279-e639-4e4a-9c63-9652cd2acbbd.html,,dermal,discriminating dose,"3,000 mg/kg bw",adverse effect observed, "2-[(3-aziridin-1-ylpropionyl)methyl]-2-ethylpropane-1,3-diyl bis(aziridine-1-propionate)",52234-82-9,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7feab210-71b4-49a8-9915-d4023fe96d7d/documents/7a5157d4-77a0-4e34-a11d-589ec9107984_76de1279-e639-4e4a-9c63-9652cd2acbbd.html,,inhalation,discriminating conc.,"1,000 mg/m3",adverse effect observed, 2-methylimidazole,693-98-1," Repeated dose toxicity via oral route - systemic effects (target organ): digestive: liver; glandular: thyroids In the 2-year feeding study with rats LOAELs of 13 and 50 mg/kg bw/day were established for male and female rats, respectively, based on an increased incidence of thyroid gland follicular cell hyperplasia at all dose levels. In the 2-year study with mice, a LOAEL of 75 mg/kg bw/day was established for males based on increased incidences of hematopoietic cell proliferation and the increased incidence of hepatocellular adenoma or carcinoma in all exposed groups. For females, a NOAEL of 80 mg/kg bw/day was established for toxicity, based on an increased incidence of thyroid gland follicular cell hypertrophy and decreases in automated and manual hematocrit values, hemoglobin concentrations and erythrocyte counts at the next dose levels. In the 14-week feeding study with rats, based on the increased incidences of diffuse thyroid follicular cell hyperplasia at 2500 ppm (160 mg/kg bw/d), as well as kidney and erythropoietic effects, a NOAEL of 1250 ppm (80 mg/kg bw/d) was established. In the 14-week feeding study with mice, a NOAEL of 625 ppm (100 mg/kg bw/d) was established, based on the effects observed in liver, kidney and the erythropoietic system. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a5163eb-f100-4bb1-b3c7-9ea39363227f/documents/IUC5-da1dd6b5-a966-463c-8126-5f9c0974d7e3_a1d45d8e-1681-4c78-8ce3-da946134636d.html,,,,,, 2-methylimidazole,693-98-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a5163eb-f100-4bb1-b3c7-9ea39363227f/documents/IUC5-da1dd6b5-a966-463c-8126-5f9c0974d7e3_a1d45d8e-1681-4c78-8ce3-da946134636d.html,Chronic toxicity – systemic effects,oral,LOAEL,13 mg/kg bw/day,,rat 2-methylimidazole,693-98-1, In rats the oral LD50 was 1500 mg/kg bw. The inhalation of a saturated vapour-air-mixture represents an unlikely acute hazard. In the acute dermal toxicity study a LD50 value of > 2000 mg/kg bw was determined. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a5163eb-f100-4bb1-b3c7-9ea39363227f/documents/IUC5-6cff783a-e5d9-4c07-930a-cd30ce512b0b_a1d45d8e-1681-4c78-8ce3-da946134636d.html,,,,,, 2-methylimidazole,693-98-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a5163eb-f100-4bb1-b3c7-9ea39363227f/documents/IUC5-6cff783a-e5d9-4c07-930a-cd30ce512b0b_a1d45d8e-1681-4c78-8ce3-da946134636d.html,,oral,LD50,"1,500 mg/kg bw",adverse effect observed, 2-methylimidazole,693-98-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a5163eb-f100-4bb1-b3c7-9ea39363227f/documents/IUC5-6cff783a-e5d9-4c07-930a-cd30ce512b0b_a1d45d8e-1681-4c78-8ce3-da946134636d.html,,dermal,discriminating dose,"2,000 mg/kg bw",adverse effect observed, "cyproconazole (ISO); (2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol",94361-06-5,"- Oral: NOAEL = 80 ppm (6.4 and 7.0 mg/kg bw/day in for males and females, respectively), rats, 90 days, dietary, OECD TG 408, Skinner 1985 ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce74afe0-b503-4068-b848-527a2a26b6d9/documents/f55ab57c-ecb9-4939-b437-9608f558a5e4_2604c2c6-08b9-414b-bc7a-f23a553ac5be.html,,,,,, "cyproconazole (ISO); (2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol",94361-06-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce74afe0-b503-4068-b848-527a2a26b6d9/documents/f55ab57c-ecb9-4939-b437-9608f558a5e4_2604c2c6-08b9-414b-bc7a-f23a553ac5be.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,6.4 mg/kg bw/day,,rat "cyproconazole (ISO); (2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol",94361-06-5,"- Oral: Male LD50 = 200 mg/kg bw and female LD50 = 218 mg/kg bw, male/female, mice, according to OECD TG 401, Hamburger 1984 - Inhalation: LC50 > 5.65 mg/L, males/female, rat, according to OECD TG 403, Ullman 1985 - Dermal: LD50 > 2000 mg/L, males/females, rat, according to OECD TG 402, Durando 2005 ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce74afe0-b503-4068-b848-527a2a26b6d9/documents/216f215b-73cd-49ba-aaf1-20e541db3e9d_2604c2c6-08b9-414b-bc7a-f23a553ac5be.html,,,,,, "cyproconazole (ISO); (2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol",94361-06-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce74afe0-b503-4068-b848-527a2a26b6d9/documents/216f215b-73cd-49ba-aaf1-20e541db3e9d_2604c2c6-08b9-414b-bc7a-f23a553ac5be.html,,oral,LD50,200 mg/kg bw,adverse effect observed, "cyproconazole (ISO); (2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol",94361-06-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce74afe0-b503-4068-b848-527a2a26b6d9/documents/216f215b-73cd-49ba-aaf1-20e541db3e9d_2604c2c6-08b9-414b-bc7a-f23a553ac5be.html,,dermal,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, "cyproconazole (ISO); (2RS,3RS;2RS,3SR)-2-(4-chlorophenyl)-3-cyclopropyl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol",94361-06-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce74afe0-b503-4068-b848-527a2a26b6d9/documents/216f215b-73cd-49ba-aaf1-20e541db3e9d_2604c2c6-08b9-414b-bc7a-f23a553ac5be.html,,inhalation,discriminating conc.,> 5.65 mg/L,no adverse effect observed, Di-tert-butyl peroxide,110-05-4,"Two repeated dose toxicity studies were available in the rat, an oral OECD 422 study and a 90-day inhalation study (OECD 413). For the 90-day study, the inhalation route was chosen because of the relatively high vapour pressure and as such likely exposure via inhalation. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb52e4c6-a871-406b-88a1-b5b6e80c7377/documents/IUC5-1587c47f-2138-46bb-98c5-0a7f4ff8336d_956ebe6c-620e-4dde-bf39-f0c6a384e255.html,,,,,, Di-tert-butyl peroxide,110-05-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb52e4c6-a871-406b-88a1-b5b6e80c7377/documents/IUC5-1587c47f-2138-46bb-98c5-0a7f4ff8336d_956ebe6c-620e-4dde-bf39-f0c6a384e255.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Di-tert-butyl peroxide,110-05-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb52e4c6-a871-406b-88a1-b5b6e80c7377/documents/IUC5-1587c47f-2138-46bb-98c5-0a7f4ff8336d_956ebe6c-620e-4dde-bf39-f0c6a384e255.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,993 mg/m3,,rat Di-tert-butyl peroxide,110-05-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb52e4c6-a871-406b-88a1-b5b6e80c7377/documents/IUC5-1587c47f-2138-46bb-98c5-0a7f4ff8336d_956ebe6c-620e-4dde-bf39-f0c6a384e255.html,Repeated dose toxicity – local effects,inhalation,NOAEC,993 mg/m3,no adverse effect observed,rat Di-tert-butyl peroxide,110-05-4,"The median lethal doses of di-tert-butyl peroxide (CAS# 110-05-4) after single administration to rats, observed over a period of 14 days, are: oral LD50 greater than 2000 mg/kg body weight; acute dermal LD50 greater than 2000 mg/kg body weight; and acute inhalation LC50 (4 hr) greater than 22 mg/l (22000 mg/m3). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb52e4c6-a871-406b-88a1-b5b6e80c7377/documents/IUC5-90582d0f-85f4-486b-93a1-170deb712e24_956ebe6c-620e-4dde-bf39-f0c6a384e255.html,,,,,, Di-tert-butyl peroxide,110-05-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb52e4c6-a871-406b-88a1-b5b6e80c7377/documents/IUC5-90582d0f-85f4-486b-93a1-170deb712e24_956ebe6c-620e-4dde-bf39-f0c6a384e255.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Di-tert-butyl peroxide,110-05-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb52e4c6-a871-406b-88a1-b5b6e80c7377/documents/IUC5-90582d0f-85f4-486b-93a1-170deb712e24_956ebe6c-620e-4dde-bf39-f0c6a384e255.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Di-tert-butyl peroxide,110-05-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb52e4c6-a871-406b-88a1-b5b6e80c7377/documents/IUC5-90582d0f-85f4-486b-93a1-170deb712e24_956ebe6c-620e-4dde-bf39-f0c6a384e255.html,,inhalation,LC50,"22,000 mg/m3",no adverse effect observed, Dimethyltin dichloride,753-73-1,"Key Study: Beyrouty (1997): 90 dayLOAEL (rats) = 25 ppm (equivalent to 1.6 and 2.2 mg/kg/day for males and females, respectively) Reduced food (males only) and water intake and neuropathological lesions. Vacuolisation of white matter in the brain and spinal cord was also observed for animals in the 25 ppm group.Main supporting study: Appel (2000): 90 day NOAEL (rats) = 0.98 mg/kg day bw (males) and 0.98 mg/kg day bw (females) NeurotoxicityThis result is applicable to cover the REACH endpoints 8.6.1 and 8.6.2. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13c69d32-1d5d-4ff2-a340-594e2bd246cf/documents/IUC5-f9ee75b1-619c-4128-990a-3711a637b1f4_6ce4f812-36d5-49d1-8497-54b7b70da510.html,,,,,, Dimethyltin dichloride,753-73-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13c69d32-1d5d-4ff2-a340-594e2bd246cf/documents/IUC5-f9ee75b1-619c-4128-990a-3711a637b1f4_6ce4f812-36d5-49d1-8497-54b7b70da510.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,1.6 mg/kg bw/day,,rat Dimethyltin dichloride,753-73-1,Oral Key Study: Rush (1993): LD50 = 204.5 mg/kg using male and female ratsOral Key Study: Cooper and Terrell (1979): LD50 = 160 mg/kg in female ratsInhaltion Key Study: Sachsse and Ullmann (1977): 4 hour LC50 = 115 mg/m³ air (analytical) using male and female ratsDermal Key Study: Rush (1993): 24 hour LD50 = 404 mg/kg bw using male and female rabbits ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13c69d32-1d5d-4ff2-a340-594e2bd246cf/documents/IUC5-68098548-9217-4a76-9dcd-f2480b5658df_6ce4f812-36d5-49d1-8497-54b7b70da510.html,,,,,, Dimethyltin dichloride,753-73-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13c69d32-1d5d-4ff2-a340-594e2bd246cf/documents/IUC5-68098548-9217-4a76-9dcd-f2480b5658df_6ce4f812-36d5-49d1-8497-54b7b70da510.html,,oral,LD50,160 mg/kg bw,adverse effect observed, Dimethyltin dichloride,753-73-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13c69d32-1d5d-4ff2-a340-594e2bd246cf/documents/IUC5-68098548-9217-4a76-9dcd-f2480b5658df_6ce4f812-36d5-49d1-8497-54b7b70da510.html,,dermal,LD50,404 mg/kg bw,adverse effect observed, Dimethyltin dichloride,753-73-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13c69d32-1d5d-4ff2-a340-594e2bd246cf/documents/IUC5-68098548-9217-4a76-9dcd-f2480b5658df_6ce4f812-36d5-49d1-8497-54b7b70da510.html,,inhalation,LC50,115 mg/m3,adverse effect observed, Potassium permanganate,7722-64-7, Oral: The 28d NOAEL (No Observed Adverse Effect Level) = 40 mg/kg/day for rat Oral: The extrapolated 90d NOAEL (No Observed Adverse Effect Level) = 13 mg/kg/day for rat Dermal: The 28d NOAEL (No Observed Adverse Effect Level) for MALES and FEMALES = 150 mg/kg/day for rat Oral: 14 days and 90 days NTP 1993 study on analogue substance Mn2+ ( MnSO4) Weight if evidence: several published literature on repeat dose toxicity from manganese exposure Inhalation: Under the conditions of the study the No Observed Adverse Effect Level (NOAEL) for the parental animals administered the read-across substance was determined to be 20 µg/L. ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb75a0f3-a896-4f03-9ffc-b79b7c1e20d9/documents/IUC5-ebcddd73-891c-40df-b382-53979f599682_f17291f0-8b75-4744-ab4f-7bc55c28d0f0.html,,,,,, Potassium permanganate,7722-64-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb75a0f3-a896-4f03-9ffc-b79b7c1e20d9/documents/IUC5-ebcddd73-891c-40df-b382-53979f599682_f17291f0-8b75-4744-ab4f-7bc55c28d0f0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat Potassium permanganate,7722-64-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb75a0f3-a896-4f03-9ffc-b79b7c1e20d9/documents/IUC5-ebcddd73-891c-40df-b382-53979f599682_f17291f0-8b75-4744-ab4f-7bc55c28d0f0.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,150 mg/kg bw/day,,rat Potassium permanganate,7722-64-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb75a0f3-a896-4f03-9ffc-b79b7c1e20d9/documents/IUC5-ebcddd73-891c-40df-b382-53979f599682_f17291f0-8b75-4744-ab4f-7bc55c28d0f0.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,20 mg/m3,,rat Potassium permanganate,7722-64-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb75a0f3-a896-4f03-9ffc-b79b7c1e20d9/documents/IUC5-ebcddd73-891c-40df-b382-53979f599682_f17291f0-8b75-4744-ab4f-7bc55c28d0f0.html,Repeated dose toxicity – local effects,inhalation,NOAEC,20 mg/m3,adverse effect observed,rat Potassium permanganate,7722-64-7,Oral LD50:>2000 mg/kg bw for rat (limit test)Dermal LD50:>2000 mg/kg bw for rat (limit test) ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb75a0f3-a896-4f03-9ffc-b79b7c1e20d9/documents/IUC5-d776dd6a-952e-4928-88c7-03d3066876cf_f17291f0-8b75-4744-ab4f-7bc55c28d0f0.html,,,,,, Potassium permanganate,7722-64-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb75a0f3-a896-4f03-9ffc-b79b7c1e20d9/documents/IUC5-d776dd6a-952e-4928-88c7-03d3066876cf_f17291f0-8b75-4744-ab4f-7bc55c28d0f0.html,,oral,LD50,"2,000 mg/kg bw",, Potassium permanganate,7722-64-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb75a0f3-a896-4f03-9ffc-b79b7c1e20d9/documents/IUC5-d776dd6a-952e-4928-88c7-03d3066876cf_f17291f0-8b75-4744-ab4f-7bc55c28d0f0.html,,dermal,LD50,"2,000 mg/kg bw",, "Distillates (petroleum), catalytic reformed depentanizer",68475-79-6,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a1676b4-dcab-4357-8ae5-a84ca1ffa7f4/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_db6f128b-b21b-43e6-ad31-07f1f20dfdcb.html,,,,,, "Distillates (petroleum), catalytic reformed depentanizer",68475-79-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a1676b4-dcab-4357-8ae5-a84ca1ffa7f4/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_db6f128b-b21b-43e6-ad31-07f1f20dfdcb.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Distillates (petroleum), catalytic reformed depentanizer",68475-79-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a1676b4-dcab-4357-8ae5-a84ca1ffa7f4/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_db6f128b-b21b-43e6-ad31-07f1f20dfdcb.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Distillates (petroleum), catalytic reformed depentanizer",68475-79-6," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a1676b4-dcab-4357-8ae5-a84ca1ffa7f4/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_db6f128b-b21b-43e6-ad31-07f1f20dfdcb.html,,,,,, "Distillates (petroleum), catalytic reformed depentanizer",68475-79-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a1676b4-dcab-4357-8ae5-a84ca1ffa7f4/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_db6f128b-b21b-43e6-ad31-07f1f20dfdcb.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), catalytic reformed depentanizer",68475-79-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a1676b4-dcab-4357-8ae5-a84ca1ffa7f4/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_db6f128b-b21b-43e6-ad31-07f1f20dfdcb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), catalytic reformed depentanizer",68475-79-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a1676b4-dcab-4357-8ae5-a84ca1ffa7f4/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_db6f128b-b21b-43e6-ad31-07f1f20dfdcb.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha (petroleum), catalytic reformed",68955-35-1,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d9d76d74-aa28-414d-bc08-f799083c9f85/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_bb02119a-bd77-4263-96f7-59b262f6bc17.html,,,,,, "Naphtha (petroleum), catalytic reformed",68955-35-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d9d76d74-aa28-414d-bc08-f799083c9f85/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_bb02119a-bd77-4263-96f7-59b262f6bc17.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), catalytic reformed",68955-35-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d9d76d74-aa28-414d-bc08-f799083c9f85/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_bb02119a-bd77-4263-96f7-59b262f6bc17.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), catalytic reformed",68955-35-1," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9d76d74-aa28-414d-bc08-f799083c9f85/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_bb02119a-bd77-4263-96f7-59b262f6bc17.html,,,,,, "Naphtha (petroleum), catalytic reformed",68955-35-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9d76d74-aa28-414d-bc08-f799083c9f85/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_bb02119a-bd77-4263-96f7-59b262f6bc17.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), catalytic reformed",68955-35-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9d76d74-aa28-414d-bc08-f799083c9f85/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_bb02119a-bd77-4263-96f7-59b262f6bc17.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), catalytic reformed",68955-35-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9d76d74-aa28-414d-bc08-f799083c9f85/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_bb02119a-bd77-4263-96f7-59b262f6bc17.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Distillates (petroleum), steam-cracked, C5-12 fraction",68477-53-2,"Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene / n-hexane - when present at 10%). Adequate information is available on the constituents to characterise the repeated dermal hazards of these streams. Adequate information is available on the constituents to characterise the repeated inhalation hazards of these streams. Adequate information is available on the constituents to characterise the repeated oral hazards of these streams. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed99b113-ef4c-4992-b26c-ae3068cdc253/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_bbb11f6e-1776-4674-b753-a73b745fd6c6.html,,,,,, "Distillates (petroleum), steam-cracked, C5-12 fraction",68477-53-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed99b113-ef4c-4992-b26c-ae3068cdc253/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_bbb11f6e-1776-4674-b753-a73b745fd6c6.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), steam-cracked, C5-12 fraction",68477-53-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed99b113-ef4c-4992-b26c-ae3068cdc253/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_bbb11f6e-1776-4674-b753-a73b745fd6c6.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Distillates (petroleum), steam-cracked, C5-12 fraction",68477-53-2,"Available data for one stream within this category (CAS 68516-20-1) and data on specific constituents (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Adequate information is available to characterise the short-term hazards of these streams. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed99b113-ef4c-4992-b26c-ae3068cdc253/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_bbb11f6e-1776-4674-b753-a73b745fd6c6.html,,,,,, "Distillates (petroleum), steam-cracked, C5-12 fraction",68477-53-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed99b113-ef4c-4992-b26c-ae3068cdc253/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_bbb11f6e-1776-4674-b753-a73b745fd6c6.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), steam-cracked, C5-12 fraction",68477-53-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed99b113-ef4c-4992-b26c-ae3068cdc253/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_bbb11f6e-1776-4674-b753-a73b745fd6c6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), steam-cracked, C5-12 fraction",68477-53-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed99b113-ef4c-4992-b26c-ae3068cdc253/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_bbb11f6e-1776-4674-b753-a73b745fd6c6.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, "Distillates (coal tar), benzole fraction, BTX-rich",101896-26-8,Theoral LD50 of light oil is greater than 2000 mg/kg bw. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43f80c4d-0fad-4df4-b799-309486fe92e5/documents/IUC5-0480e7d2-f952-4519-82a9-5101c869ff5d_bf60bf63-64fc-4c67-bbb4-0d2b06b1163d.html,,,,,, "Naphtha (petroleum), light steam-cracked, debenzenized",68527-26-4," Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene - when present at 10%; n-hexane - when present at 5%). ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0fdcdf1-12c3-47e7-bc42-83ccf93df1bb/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_3ea56285-e596-4035-a951-c50fd2809dbb.html,,,,,, "Naphtha (petroleum), light steam-cracked, debenzenized",68527-26-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0fdcdf1-12c3-47e7-bc42-83ccf93df1bb/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_3ea56285-e596-4035-a951-c50fd2809dbb.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Naphtha (petroleum), light steam-cracked, debenzenized",68527-26-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0fdcdf1-12c3-47e7-bc42-83ccf93df1bb/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_3ea56285-e596-4035-a951-c50fd2809dbb.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Naphtha (petroleum), light steam-cracked, debenzenized",68527-26-4," Available data for one stream within this category (CAS 68516-20-1) and data on specific components (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0fdcdf1-12c3-47e7-bc42-83ccf93df1bb/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_3ea56285-e596-4035-a951-c50fd2809dbb.html,,,,,, "Naphtha (petroleum), light steam-cracked, debenzenized",68527-26-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0fdcdf1-12c3-47e7-bc42-83ccf93df1bb/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_3ea56285-e596-4035-a951-c50fd2809dbb.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light steam-cracked, debenzenized",68527-26-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0fdcdf1-12c3-47e7-bc42-83ccf93df1bb/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_3ea56285-e596-4035-a951-c50fd2809dbb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light steam-cracked, debenzenized",68527-26-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0fdcdf1-12c3-47e7-bc42-83ccf93df1bb/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_3ea56285-e596-4035-a951-c50fd2809dbb.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, "Hydrocarbons, C≥5, C5-6-rich",68476-50-6,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f6db572-cdbd-48b7-b2c2-81c869dcef6c/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_2ffd1e7e-6136-497d-9cd2-b79903953357.html,,,,,, "Hydrocarbons, C≥5, C5-6-rich",68476-50-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f6db572-cdbd-48b7-b2c2-81c869dcef6c/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_2ffd1e7e-6136-497d-9cd2-b79903953357.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Hydrocarbons, C≥5, C5-6-rich",68476-50-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f6db572-cdbd-48b7-b2c2-81c869dcef6c/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_2ffd1e7e-6136-497d-9cd2-b79903953357.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Hydrocarbons, C≥5, C5-6-rich",68476-50-6," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f6db572-cdbd-48b7-b2c2-81c869dcef6c/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_2ffd1e7e-6136-497d-9cd2-b79903953357.html,,,,,, "Hydrocarbons, C≥5, C5-6-rich",68476-50-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f6db572-cdbd-48b7-b2c2-81c869dcef6c/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_2ffd1e7e-6136-497d-9cd2-b79903953357.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C≥5, C5-6-rich",68476-50-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f6db572-cdbd-48b7-b2c2-81c869dcef6c/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_2ffd1e7e-6136-497d-9cd2-b79903953357.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C≥5, C5-6-rich",68476-50-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f6db572-cdbd-48b7-b2c2-81c869dcef6c/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_2ffd1e7e-6136-497d-9cd2-b79903953357.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Hydrocarbons, C6-11, hydrotreated, dearomatized",93763-33-8,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/52fd17b6-f5e7-40d0-847e-11e2af69884d/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_808aa7b6-8fbc-46ad-a7da-e823ef92692a.html,,,,,, "Hydrocarbons, C6-11, hydrotreated, dearomatized",93763-33-8,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/52fd17b6-f5e7-40d0-847e-11e2af69884d/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_808aa7b6-8fbc-46ad-a7da-e823ef92692a.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Hydrocarbons, C6-11, hydrotreated, dearomatized",93763-33-8,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/52fd17b6-f5e7-40d0-847e-11e2af69884d/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_808aa7b6-8fbc-46ad-a7da-e823ef92692a.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Hydrocarbons, C6-11, hydrotreated, dearomatized",93763-33-8,"The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401)Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions)Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52fd17b6-f5e7-40d0-847e-11e2af69884d/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_808aa7b6-8fbc-46ad-a7da-e823ef92692a.html,,,,,, "Hydrocarbons, C6-11, hydrotreated, dearomatized",93763-33-8,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52fd17b6-f5e7-40d0-847e-11e2af69884d/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_808aa7b6-8fbc-46ad-a7da-e823ef92692a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C6-11, hydrotreated, dearomatized",93763-33-8,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52fd17b6-f5e7-40d0-847e-11e2af69884d/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_808aa7b6-8fbc-46ad-a7da-e823ef92692a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C6-11, hydrotreated, dearomatized",93763-33-8,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52fd17b6-f5e7-40d0-847e-11e2af69884d/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_808aa7b6-8fbc-46ad-a7da-e823ef92692a.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Hydrocarbons, C3-11, catalytic cracker distillates",68476-46-0,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8217ed6-551e-46df-b284-08a2528da574/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_916166a3-075d-4835-b940-df4f6364ca24.html,,,,,, "Hydrocarbons, C3-11, catalytic cracker distillates",68476-46-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8217ed6-551e-46df-b284-08a2528da574/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_916166a3-075d-4835-b940-df4f6364ca24.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Hydrocarbons, C3-11, catalytic cracker distillates",68476-46-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8217ed6-551e-46df-b284-08a2528da574/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_916166a3-075d-4835-b940-df4f6364ca24.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Hydrocarbons, C3-11, catalytic cracker distillates",68476-46-0," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8217ed6-551e-46df-b284-08a2528da574/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_916166a3-075d-4835-b940-df4f6364ca24.html,,,,,, "Hydrocarbons, C3-11, catalytic cracker distillates",68476-46-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8217ed6-551e-46df-b284-08a2528da574/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_916166a3-075d-4835-b940-df4f6364ca24.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C3-11, catalytic cracker distillates",68476-46-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8217ed6-551e-46df-b284-08a2528da574/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_916166a3-075d-4835-b940-df4f6364ca24.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C3-11, catalytic cracker distillates",68476-46-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8217ed6-551e-46df-b284-08a2528da574/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_916166a3-075d-4835-b940-df4f6364ca24.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, [carbonato(2-)]tetrahydroxytrinickel,12607-70-4," Value used for CSA (read-across from Nickel sulphate or Nickel subsulphide): NOAEL (oral, systemic, animal, read-across from Ni sulphate): 2.2 mg Ni/kg bw/day (Heim et al, 2007) LOAEC (inhalation, local, animal, read-across from Ni subsulphide): 0.11 mg Ni/m3 = 0.15 mg Ni3S2/m3 (Dunnick et al., 1995) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca785271-f3fc-4113-96e1-5385789816cc/documents/aef128c2-37c5-4cd7-8993-2a70d6003ee8_20095916-4299-46ed-b518-302c69e85960.html,,,,,, [carbonato(2-)]tetrahydroxytrinickel,12607-70-4,"Value used for CSA: NOAEL (oral, systemic, animal):790 mg/kg bw (383 mg Ni/kg/day) (EPSL, 2009a) LOAEL (oral, systemic, human):0.012 mg Ni/kg bw/day (Nielsen et al, 1999) NOAEC (inhalation, systemic, animal): 0.053 mg/L (26 mg Ni/m3; males, MMAD=1.9 µm) (EPSL, 2010) LOAEC (inhalation, local, animal; read-across): 0.47 mg Ni/m3 (DNEL calculation is based on 12-day repeated dose study-Benson et al, 1987; no appropriate acute data is available) An acute local inhalation DNEL is derived based on the lung effects (e.g. lung inflammation) associated with nickel subsulphide inhalation.  The shortest-term study available examining those effects in animals is a 12-day repeated exposure study.  An adjustment factor was derived to extrapolate the results from the repeated exposure study to an equivalent effect concentration in a 4 hr acute exposure.  See Appendix C3 for more information. (Oral, local values are not applicable; Dermal, local or systemic, values are not applicable) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca785271-f3fc-4113-96e1-5385789816cc/documents/19dcdf81-feb8-4059-a1bb-2cf81e81cf31_20095916-4299-46ed-b518-302c69e85960.html,,,,,, [carbonato(2-)]tetrahydroxytrinickel,12607-70-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca785271-f3fc-4113-96e1-5385789816cc/documents/19dcdf81-feb8-4059-a1bb-2cf81e81cf31_20095916-4299-46ed-b518-302c69e85960.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, [carbonato(2-)]tetrahydroxytrinickel,12607-70-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca785271-f3fc-4113-96e1-5385789816cc/documents/19dcdf81-feb8-4059-a1bb-2cf81e81cf31_20095916-4299-46ed-b518-302c69e85960.html,,inhalation,LC50,0.24 mg/L,, Distillates (coal tar),65996-92-1,"Anthracene oil is expected to show little acute toxicity, based on results obtained from closely related tar oils: LD50(oral, rat) ~ 4000 mg/kg bw, LD50(dermal, rat) > 2000 mg/kg bw. No acute intoxication is expected from inhalation exposure, given the low vapour pressure and observed low toxicity of this test substance. Inhalation will be assessed for repeated exposure (see IUCLID 7.5.3). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3069ce7f-4d74-405b-a9b9-ef0c11a76350/documents/IUC5-e8599da6-a068-4430-9f16-b6e763a5226d_719ccadf-cadd-483b-bfa1-42aa76ad422f.html,,,,,, "Solvent naphtha (petroleum), light aliph.",64742-89-8,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c0365da-bab2-4a14-8570-7e687316dfe3/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_3dc1bf95-cffa-4726-b766-0de14f0c3fd8.html,,,,,, "Solvent naphtha (petroleum), light aliph.",64742-89-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c0365da-bab2-4a14-8570-7e687316dfe3/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_3dc1bf95-cffa-4726-b766-0de14f0c3fd8.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Solvent naphtha (petroleum), light aliph.",64742-89-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c0365da-bab2-4a14-8570-7e687316dfe3/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_3dc1bf95-cffa-4726-b766-0de14f0c3fd8.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Solvent naphtha (petroleum), light aliph.",64742-89-8," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c0365da-bab2-4a14-8570-7e687316dfe3/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_3dc1bf95-cffa-4726-b766-0de14f0c3fd8.html,,,,,, "Solvent naphtha (petroleum), light aliph.",64742-89-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c0365da-bab2-4a14-8570-7e687316dfe3/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_3dc1bf95-cffa-4726-b766-0de14f0c3fd8.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Solvent naphtha (petroleum), light aliph.",64742-89-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c0365da-bab2-4a14-8570-7e687316dfe3/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_3dc1bf95-cffa-4726-b766-0de14f0c3fd8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Solvent naphtha (petroleum), light aliph.",64742-89-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c0365da-bab2-4a14-8570-7e687316dfe3/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_3dc1bf95-cffa-4726-b766-0de14f0c3fd8.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha (petroleum), catalytic dewaxed",64742-66-1,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/1445a05d-4404-465c-96fa-eddeadc593c0/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_dfe91e51-9712-40c5-8978-5396aff5fe66.html,,,,,, "Naphtha (petroleum), catalytic dewaxed",64742-66-1,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/1445a05d-4404-465c-96fa-eddeadc593c0/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_dfe91e51-9712-40c5-8978-5396aff5fe66.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), catalytic dewaxed",64742-66-1,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/1445a05d-4404-465c-96fa-eddeadc593c0/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_dfe91e51-9712-40c5-8978-5396aff5fe66.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), catalytic dewaxed",64742-66-1,"The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401)Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions)Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1445a05d-4404-465c-96fa-eddeadc593c0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_dfe91e51-9712-40c5-8978-5396aff5fe66.html,,,,,, "Naphtha (petroleum), catalytic dewaxed",64742-66-1,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1445a05d-4404-465c-96fa-eddeadc593c0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_dfe91e51-9712-40c5-8978-5396aff5fe66.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), catalytic dewaxed",64742-66-1,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1445a05d-4404-465c-96fa-eddeadc593c0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_dfe91e51-9712-40c5-8978-5396aff5fe66.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), catalytic dewaxed",64742-66-1,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1445a05d-4404-465c-96fa-eddeadc593c0/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_dfe91e51-9712-40c5-8978-5396aff5fe66.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, Natural gas condensates (petroleum),64741-47-5," Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene - when present at 10%; n-hexane - when present at 5%). ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd381e47-af95-4201-9aad-882ef074373b/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_cb581f27-ecde-4836-8a05-a90a90ef7be8.html,,,,,, Natural gas condensates (petroleum),64741-47-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd381e47-af95-4201-9aad-882ef074373b/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_cb581f27-ecde-4836-8a05-a90a90ef7be8.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat Natural gas condensates (petroleum),64741-47-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd381e47-af95-4201-9aad-882ef074373b/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_cb581f27-ecde-4836-8a05-a90a90ef7be8.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human Natural gas condensates (petroleum),64741-47-5," Available data for one stream within this category (CAS 68516-20-1) and data on specific components (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd381e47-af95-4201-9aad-882ef074373b/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_cb581f27-ecde-4836-8a05-a90a90ef7be8.html,,,,,, Natural gas condensates (petroleum),64741-47-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd381e47-af95-4201-9aad-882ef074373b/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_cb581f27-ecde-4836-8a05-a90a90ef7be8.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Natural gas condensates (petroleum),64741-47-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd381e47-af95-4201-9aad-882ef074373b/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_cb581f27-ecde-4836-8a05-a90a90ef7be8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Natural gas condensates (petroleum),64741-47-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd381e47-af95-4201-9aad-882ef074373b/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_cb581f27-ecde-4836-8a05-a90a90ef7be8.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, "2,5-xylidine",95-78-3," Repeated dose toxicity: Oral Low Observed Adverse Effect Level (LOAEL) was considered to be in the range of 475-500 mg/kg body weight, when rats were treated with the given test chemical via oral route for 28 days. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ebc804d-30ff-4eab-8503-b6a8fcad7add/documents/1bbf3268-487e-4711-9465-7605c1738c60_e874e267-329e-4f47-b4e3-9f412b85eb06.html,,,,,, "2,5-xylidine",95-78-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ebc804d-30ff-4eab-8503-b6a8fcad7add/documents/1bbf3268-487e-4711-9465-7605c1738c60_e874e267-329e-4f47-b4e3-9f412b85eb06.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,475 mg/kg bw/day,,rat "2,5-xylidine",95-78-3," The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is 1297 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified as category 4 for acute oral toxicity. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ebc804d-30ff-4eab-8503-b6a8fcad7add/documents/9e01704c-a3f8-41d7-bc7a-ca931aa13e0c_e874e267-329e-4f47-b4e3-9f412b85eb06.html,,,,,, "2,5-xylidine",95-78-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ebc804d-30ff-4eab-8503-b6a8fcad7add/documents/9e01704c-a3f8-41d7-bc7a-ca931aa13e0c_e874e267-329e-4f47-b4e3-9f412b85eb06.html,,oral,LD50,"1,297 mg/kg bw",adverse effect observed, "Hydrocarbons, C4-6, depentanizer lights, arom. hydrotreater",91995-38-9,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a58f136-919c-4c22-84e9-0043c504e584/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_96658d83-3b74-48f6-91d0-4a017084aad9.html,,,,,, "Hydrocarbons, C4-6, depentanizer lights, arom. hydrotreater",91995-38-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a58f136-919c-4c22-84e9-0043c504e584/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_96658d83-3b74-48f6-91d0-4a017084aad9.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Hydrocarbons, C4-6, depentanizer lights, arom. hydrotreater",91995-38-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a58f136-919c-4c22-84e9-0043c504e584/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_96658d83-3b74-48f6-91d0-4a017084aad9.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Hydrocarbons, C4-6, depentanizer lights, arom. hydrotreater",91995-38-9," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a58f136-919c-4c22-84e9-0043c504e584/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_96658d83-3b74-48f6-91d0-4a017084aad9.html,,,,,, "Hydrocarbons, C4-6, depentanizer lights, arom. hydrotreater",91995-38-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a58f136-919c-4c22-84e9-0043c504e584/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_96658d83-3b74-48f6-91d0-4a017084aad9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C4-6, depentanizer lights, arom. hydrotreater",91995-38-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a58f136-919c-4c22-84e9-0043c504e584/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_96658d83-3b74-48f6-91d0-4a017084aad9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C4-6, depentanizer lights, arom. hydrotreater",91995-38-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a58f136-919c-4c22-84e9-0043c504e584/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_96658d83-3b74-48f6-91d0-4a017084aad9.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha (petroleum), light catalytic reformed, arom.-free",68513-03-1,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65f52a60-f328-4e2d-b588-c29bf5c2da98/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_c9dbc34e-9781-4d2e-984b-28141d1371df.html,,,,,, "Naphtha (petroleum), light catalytic reformed, arom.-free",68513-03-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65f52a60-f328-4e2d-b588-c29bf5c2da98/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_c9dbc34e-9781-4d2e-984b-28141d1371df.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), light catalytic reformed, arom.-free",68513-03-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65f52a60-f328-4e2d-b588-c29bf5c2da98/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_c9dbc34e-9781-4d2e-984b-28141d1371df.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), light catalytic reformed, arom.-free",68513-03-1," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65f52a60-f328-4e2d-b588-c29bf5c2da98/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_c9dbc34e-9781-4d2e-984b-28141d1371df.html,,,,,, "Naphtha (petroleum), light catalytic reformed, arom.-free",68513-03-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65f52a60-f328-4e2d-b588-c29bf5c2da98/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_c9dbc34e-9781-4d2e-984b-28141d1371df.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light catalytic reformed, arom.-free",68513-03-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65f52a60-f328-4e2d-b588-c29bf5c2da98/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_c9dbc34e-9781-4d2e-984b-28141d1371df.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light catalytic reformed, arom.-free",68513-03-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65f52a60-f328-4e2d-b588-c29bf5c2da98/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_c9dbc34e-9781-4d2e-984b-28141d1371df.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, Calcium nitrite,13780-06-8," No repeated dose toxicity data with calcium nitrite were identified.   In NTP subchronic oral toxicity studies, sodium nitrite was provided to rats and mice (10/species/sex/group) in the drinking water at 375-5000 ppm (equivalent to approximate dose levels of 30-310 mg/kg bw/day for male rats, 40-345 mg/kg bw/day for female rats, 90-990 mg/kg bw/day for male mice and 120-1230 mg/kg bw/day for female mice) for 14 weeks (NTP, 2001). In reviewing these studies, EFSA considered the critical effect in rats to be a dose-dependent increase in methaemoglobin concentration (with concomitant increases in reticulocyte count and mean cell volume/haemoglobin concentration at the two highest dose levels). On this basis, EFSA established respective NOAELs of 115 and 130 mg/kg bw/day for male and female rats. Based on an increased incidence of extramedullary haematopoiesis in the spleen of mice, EFSA established NOAELs of 345 and 240 mg/kg bw/day for males and females, respectively (EFSA, 2017).   In the analogous chronic oral NTP toxicity studies, sodium nitrite was administered daily via drinking water to rats and mice (50/species/sex/group) at 750, 1500 or 3000 ppm (equivalent to approximate dose levels of 35, 70 or 130 mg/kg bw/day for male rats, 40, 80 or 150 mg/kg bw/day for female rats, 60, 120 or 220 mg/kg bw/day for male mice and 45, 90 or 165 mg/kg bw/day for female mice) for 2 years (NTP, 2001). The critical effect in rats was a dose-dependent increase in methaemoglobin concentration (considered by EFSA to be statistically significant at the highest tested dose level). On this basis, EFSA established respective NOAELs of 70 and 80 mg/kg bw/day for male and female rats. No significant treatment-related adverse effects were observed in mice. As such, the EFSA Panel have identified NOAELs of 220 and 165 mg/kg bw/day for male and female mice, respectively (EFSA, 2017).   No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e75a2df-6dac-4696-bf77-d07c19108433/documents/02ce3b92-b3a6-46ef-9604-76219248f357_cd1121b6-c0da-4d47-9175-dfb2ad41c2c1.html,,,,,, Calcium nitrite,13780-06-8," In a guideline study, to GLP, the acute oral LD50 of calcium nitrite was determined to be 283 mg/kg bw in rats (Olson, 1985).   No relevant acute dermal or inhalation toxicity data were identified for calcium nitrite.   According to OECD (2005) and ECB (2000) reviews, briefly describing the findings of an unpublished GLP acute inhalation study, there was no mortality or other toxicologically significant adverse effects in rats (10/sex/group) during a 14-day observation period following a 4-hr exposure to up to 100 mg/m3 of sodium nitrite (McLean-Head and Mould, 1985). As such, a 4-hr LC50 of >100 mg/m3 can be concluded for sodium nitrite. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e75a2df-6dac-4696-bf77-d07c19108433/documents/42c19af9-f1ff-4cc0-8e9e-447a0a480d76_cd1121b6-c0da-4d47-9175-dfb2ad41c2c1.html,,,,,, Calcium nitrite,13780-06-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e75a2df-6dac-4696-bf77-d07c19108433/documents/42c19af9-f1ff-4cc0-8e9e-447a0a480d76_cd1121b6-c0da-4d47-9175-dfb2ad41c2c1.html,,oral,LD50,283 mg/kg bw,adverse effect observed, "Naphtha (petroleum), light catalytic reformed",64741-63-5,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8c3307b-6b92-435f-9f45-2f7d2e53ff51/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_05fd5a25-4889-4c31-bab8-30bd71931f84.html,,,,,, "Naphtha (petroleum), light catalytic reformed",64741-63-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8c3307b-6b92-435f-9f45-2f7d2e53ff51/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_05fd5a25-4889-4c31-bab8-30bd71931f84.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), light catalytic reformed",64741-63-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8c3307b-6b92-435f-9f45-2f7d2e53ff51/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_05fd5a25-4889-4c31-bab8-30bd71931f84.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), light catalytic reformed",64741-63-5," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8c3307b-6b92-435f-9f45-2f7d2e53ff51/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_05fd5a25-4889-4c31-bab8-30bd71931f84.html,,,,,, "Naphtha (petroleum), light catalytic reformed",64741-63-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8c3307b-6b92-435f-9f45-2f7d2e53ff51/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_05fd5a25-4889-4c31-bab8-30bd71931f84.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light catalytic reformed",64741-63-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8c3307b-6b92-435f-9f45-2f7d2e53ff51/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_05fd5a25-4889-4c31-bab8-30bd71931f84.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light catalytic reformed",64741-63-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8c3307b-6b92-435f-9f45-2f7d2e53ff51/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_05fd5a25-4889-4c31-bab8-30bd71931f84.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Aromatic hydrocarbons, C6-8, naphtha-raffinate pyrolyzate-derived",68475-70-7,"Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene / n-hexane - when present at 10%). Adequate information is available on the constituents to characterise the repeated dermal hazards of these streams. Adequate information is available on the constituents to characterise the repeated inhalation hazards of these streams. Adequate information is available on the constituents to characterise the repeated oral hazards of these streams. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41da44c4-b50e-44f1-a9b9-a4ab994c81af/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_8b6cf945-0496-4c1a-9efc-1368eaca9e22.html,,,,,, "Aromatic hydrocarbons, C6-8, naphtha-raffinate pyrolyzate-derived",68475-70-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41da44c4-b50e-44f1-a9b9-a4ab994c81af/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_8b6cf945-0496-4c1a-9efc-1368eaca9e22.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Aromatic hydrocarbons, C6-8, naphtha-raffinate pyrolyzate-derived",68475-70-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41da44c4-b50e-44f1-a9b9-a4ab994c81af/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_8b6cf945-0496-4c1a-9efc-1368eaca9e22.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Aromatic hydrocarbons, C6-8, naphtha-raffinate pyrolyzate-derived",68475-70-7,"Available data for one stream within this category (CAS 68516-20-1) and data on specific constituents (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Adequate information is available to characterise the short-term hazards of these streams. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41da44c4-b50e-44f1-a9b9-a4ab994c81af/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_8b6cf945-0496-4c1a-9efc-1368eaca9e22.html,,,,,, "Aromatic hydrocarbons, C6-8, naphtha-raffinate pyrolyzate-derived",68475-70-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41da44c4-b50e-44f1-a9b9-a4ab994c81af/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_8b6cf945-0496-4c1a-9efc-1368eaca9e22.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Aromatic hydrocarbons, C6-8, naphtha-raffinate pyrolyzate-derived",68475-70-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41da44c4-b50e-44f1-a9b9-a4ab994c81af/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_8b6cf945-0496-4c1a-9efc-1368eaca9e22.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aromatic hydrocarbons, C6-8, naphtha-raffinate pyrolyzate-derived",68475-70-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41da44c4-b50e-44f1-a9b9-a4ab994c81af/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_8b6cf945-0496-4c1a-9efc-1368eaca9e22.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, "Naphtha (petroleum), heavy catalytic cracked, sweetened",92045-50-6,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/08048011-868a-44ab-805d-f90821dc90a4/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_bf982f14-b01f-4f38-97ee-dbcba7bbb944.html,,,,,, "Naphtha (petroleum), heavy catalytic cracked, sweetened",92045-50-6,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/08048011-868a-44ab-805d-f90821dc90a4/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_bf982f14-b01f-4f38-97ee-dbcba7bbb944.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), heavy catalytic cracked, sweetened",92045-50-6,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/08048011-868a-44ab-805d-f90821dc90a4/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_bf982f14-b01f-4f38-97ee-dbcba7bbb944.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), heavy catalytic cracked, sweetened",92045-50-6,"The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401)Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions)Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08048011-868a-44ab-805d-f90821dc90a4/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_bf982f14-b01f-4f38-97ee-dbcba7bbb944.html,,,,,, "Naphtha (petroleum), heavy catalytic cracked, sweetened",92045-50-6,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08048011-868a-44ab-805d-f90821dc90a4/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_bf982f14-b01f-4f38-97ee-dbcba7bbb944.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), heavy catalytic cracked, sweetened",92045-50-6,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08048011-868a-44ab-805d-f90821dc90a4/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_bf982f14-b01f-4f38-97ee-dbcba7bbb944.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), heavy catalytic cracked, sweetened",92045-50-6,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08048011-868a-44ab-805d-f90821dc90a4/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_bf982f14-b01f-4f38-97ee-dbcba7bbb944.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha (petroleum), hydrodesulfurized full-range",92045-52-8,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4e318d2-4738-42ae-b925-e1fb5c7d4291/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_badd6411-b564-4fc5-82a5-fb48c6e18c47.html,,,,,, "Naphtha (petroleum), hydrodesulfurized full-range",92045-52-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4e318d2-4738-42ae-b925-e1fb5c7d4291/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_badd6411-b564-4fc5-82a5-fb48c6e18c47.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), hydrodesulfurized full-range",92045-52-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4e318d2-4738-42ae-b925-e1fb5c7d4291/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_badd6411-b564-4fc5-82a5-fb48c6e18c47.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), hydrodesulfurized full-range",92045-52-8," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4e318d2-4738-42ae-b925-e1fb5c7d4291/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_badd6411-b564-4fc5-82a5-fb48c6e18c47.html,,,,,, "Naphtha (petroleum), hydrodesulfurized full-range",92045-52-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4e318d2-4738-42ae-b925-e1fb5c7d4291/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_badd6411-b564-4fc5-82a5-fb48c6e18c47.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), hydrodesulfurized full-range",92045-52-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4e318d2-4738-42ae-b925-e1fb5c7d4291/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_badd6411-b564-4fc5-82a5-fb48c6e18c47.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), hydrodesulfurized full-range",92045-52-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4e318d2-4738-42ae-b925-e1fb5c7d4291/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_badd6411-b564-4fc5-82a5-fb48c6e18c47.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Tar acids, brown-coal gasification",92062-22-1,"In humans and experimental animals the signs and symptoms of acute toxicity are similar regardless of the route of administration (compare also with data presented in the Summary of Section 7.1). Beside the concentration dependent local effects (corrosive properties of phenol) also systemic effects are obvious. Muscle weakness, convulsions, and coma are the predominant symptoms associated with exposure to lethal concentrations of phenol. Regardless of the route of exposure, absorption is rapid, as illustrated by the fact that acute doses of phenol can produce symptoms of toxicity within minutes after administration. For animals, dermal and oral LD50 values are reported in the literature falling within one order of magnitude: oral LD50 in rats 340 -650 mg/kg bw and dermal LD50 in rats 660 (525 -707) mg/kg bw and in rabbits 850 mg/kg bw. Although LC50 values are not available in literature, rats are reported to have tolerated phenol concentrations as high as 236 ppm (900 mg/m³) for 8 hours, resulting in ocular and nasal irritation, loss of coordination. The odour recognition threshold (100% response) of phenol in humans is approximately 0.05 ppm, a concentration far below the levels where toxic effects have been reported; thus, the chemical has good warning properties for inhalation exposure. Oral toxicity of phenol in humans leading to the death of the victim is reported for doses as low as 140-290 mg/kg body weight. Absorption from spilling phenolic solutions on the skin of humans may be very rapid, and death results from collapse within 30 minutes to several hours. Death has resulted from absorption of phenol through a skin area of 64 inch². Based on these data phenol has been classified as “toxic” and labelled with “R 23/24/25 (Toxic by inhalation, in contact with skin and if swallowed)”. ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4795d645-7d6d-467f-8a6b-659094a216a8/documents/IUC5-9a097516-2e6a-4b1b-9ef7-784a41db6d85_129b46d3-00ed-42f0-a980-689cffbfe8fc.html,,,,,, "Tar acids, brown-coal gasification",92062-22-1,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4795d645-7d6d-467f-8a6b-659094a216a8/documents/IUC5-9a097516-2e6a-4b1b-9ef7-784a41db6d85_129b46d3-00ed-42f0-a980-689cffbfe8fc.html,,oral,LD50,340 mg/kg bw,, "Tar acids, brown-coal gasification",92062-22-1,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4795d645-7d6d-467f-8a6b-659094a216a8/documents/IUC5-9a097516-2e6a-4b1b-9ef7-784a41db6d85_129b46d3-00ed-42f0-a980-689cffbfe8fc.html,,dermal,LD50,660 mg/kg bw,, "Tetrakis(diethyldithiocarbamato-S,S')tellurium",20941-65-5," In a GLP compliant OECD 422 study, a NOAEL of 1 mg/kg bw/day was determined for systemic repeated dose toxicity. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c68155a2-f72b-4884-8697-651ab42d07c9/documents/31622be1-4960-4883-8f31-cc678733f7c8_35373a3c-cc7b-4637-9f00-c7d114dc8b5c.html,,,,,, "Tetrakis(diethyldithiocarbamato-S,S')tellurium",20941-65-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c68155a2-f72b-4884-8697-651ab42d07c9/documents/31622be1-4960-4883-8f31-cc678733f7c8_35373a3c-cc7b-4637-9f00-c7d114dc8b5c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,1 mg/kg bw/day,,rat "Tetrakis(diethyldithiocarbamato-S,S')tellurium",20941-65-5, The LD50 value for acute oral toxicity was >5000 mg/kg bodyweight in rats. The LC50 value for acute inhalation toxicity was >0.51 mg/L air in rats. The LD50 value for acute dermal toxicity was >2000 mg/kg bodyweight in rats. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c68155a2-f72b-4884-8697-651ab42d07c9/documents/d4eead3d-5707-40f6-8824-c03341da2ac9_35373a3c-cc7b-4637-9f00-c7d114dc8b5c.html,,,,,, "Tetrakis(diethyldithiocarbamato-S,S')tellurium",20941-65-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c68155a2-f72b-4884-8697-651ab42d07c9/documents/d4eead3d-5707-40f6-8824-c03341da2ac9_35373a3c-cc7b-4637-9f00-c7d114dc8b5c.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Tetrakis(diethyldithiocarbamato-S,S')tellurium",20941-65-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c68155a2-f72b-4884-8697-651ab42d07c9/documents/d4eead3d-5707-40f6-8824-c03341da2ac9_35373a3c-cc7b-4637-9f00-c7d114dc8b5c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Tetrakis(diethyldithiocarbamato-S,S')tellurium",20941-65-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c68155a2-f72b-4884-8697-651ab42d07c9/documents/d4eead3d-5707-40f6-8824-c03341da2ac9_35373a3c-cc7b-4637-9f00-c7d114dc8b5c.html,,inhalation,discriminating conc.,510 mg/m3,no adverse effect observed, "Extracts, coal tar oil alk.",65996-83-0,"In humans and experimental animals the signs and symptoms of acute toxicity are similar regardless of the route of administration (compare also with data presented in the Summary of Section 7.1). Beside the concentration dependent local effects (corrosive properties of phenol) also systemic effects are obvious. Muscle weakness, convulsions, and coma are the predominant symptoms associated with exposure to lethal concentrations of phenol. Regardless of the route of exposure, absorption is rapid, as illustrated by the fact that acute doses of phenol can produce symptoms of toxicity within minutes after administration. For animals, dermal and oral LD50 values are reported in the literature falling within one order of magnitude: oral LD50 in rats 340 -650 mg/kg bw and dermal LD50 in rats 660 (525 -707) mg/kg bw and in rabbits 850 mg/kg bw. Although LC50 values are not available in literature, rats are reported to have tolerated phenol concentrations as high as 236 ppm (900 mg/m³) for 8 hours, resulting in ocular and nasal irritation, loss of coordination. The odour recognition threshold (100% response) of phenol in humans is approximately 0.05 ppm, a concentration far below the levels where toxic effects have been reported; thus, the chemical has good warning properties for inhalation exposure. Oral toxicity of phenol in humans leading to the death of the victim is reported for doses as low as 140-290 mg/kg body weight. Absorption from spilling phenolic solutions on the skin of humans may be very rapid, and death results from collapse within 30 minutes to several hours. Death has resulted from absorption of phenol through a skin area of 64 inch². Based on these data phenol has been classified as “toxic” and labelled with “R 23/24/25 (Toxic by inhalation, in contact with skin and if swallowed)”. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8c44a56-7882-42cb-83a7-09371aab1379/documents/IUC5-9bdf7b47-cce5-497b-92b9-f51971af02d4_709d4b58-ba4e-41a5-8f29-636d3f39c806.html,,,,,, "Extracts, coal tar oil alk.",65996-83-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8c44a56-7882-42cb-83a7-09371aab1379/documents/IUC5-9bdf7b47-cce5-497b-92b9-f51971af02d4_709d4b58-ba4e-41a5-8f29-636d3f39c806.html,,oral,LD50,340 mg/kg bw,, "Extracts, coal tar oil alk.",65996-83-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8c44a56-7882-42cb-83a7-09371aab1379/documents/IUC5-9bdf7b47-cce5-497b-92b9-f51971af02d4_709d4b58-ba4e-41a5-8f29-636d3f39c806.html,,dermal,LD50,660 mg/kg bw,, Betamethasone,378-44-9,"The oral toxicity of betamethasone on mouse was reported to be greater than 4500 mg/kg bw.Moreover, to support this value, some data on oral toxicity of structural related analogues in mouse or rat are reported. Most of them are direct precursors of betamethasone, who, once given, are quickly transformed into betamethasone alcohol, but dexamethasone.Dexamethasone is the most related compund as epimer of betamethasone. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03728a0c-a514-4c34-b618-dde1019e0149/documents/IUC5-10d57b06-8495-4bb1-9e2a-cca6798b3101_ff4cdc8e-175d-43b2-818d-6649aed1faae.html,,,,,, Phthalylsulfathiazole,85-73-4,The substance phthalylsulfathiazole is not toxic by oral and inhalation route through repeated dose. ,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc15f960-6a3a-4976-a560-62de0dd37ca2/documents/IUC5-a33a95d1-b66c-4aee-8fb4-be1481d2f9d2_672cd270-b75e-44a0-b08e-c3caa210f552.html,,,,,, Phthalylsulfathiazole,85-73-4,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc15f960-6a3a-4976-a560-62de0dd37ca2/documents/IUC5-a33a95d1-b66c-4aee-8fb4-be1481d2f9d2_672cd270-b75e-44a0-b08e-c3caa210f552.html,Sub-chronic toxicity – systemic effects,oral,,386.755 mg/kg bw/day,,rat Phthalylsulfathiazole,85-73-4,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc15f960-6a3a-4976-a560-62de0dd37ca2/documents/IUC5-a33a95d1-b66c-4aee-8fb4-be1481d2f9d2_672cd270-b75e-44a0-b08e-c3caa210f552.html,Sub-chronic toxicity – systemic effects,inhalation,,106.227 ,,rat Phthalylsulfathiazole,85-73-4,"it can be concluded that the substance will not have any toxicity effect in any of the route of exposure that is oral, dermal and inhalation. ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc15f960-6a3a-4976-a560-62de0dd37ca2/documents/IUC5-6d86639e-03a8-446b-b6b7-1b2d6fbdbe7d_672cd270-b75e-44a0-b08e-c3caa210f552.html,,,,,, Phthalylsulfathiazole,85-73-4,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc15f960-6a3a-4976-a560-62de0dd37ca2/documents/IUC5-6d86639e-03a8-446b-b6b7-1b2d6fbdbe7d_672cd270-b75e-44a0-b08e-c3caa210f552.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Phthalylsulfathiazole,85-73-4,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc15f960-6a3a-4976-a560-62de0dd37ca2/documents/IUC5-6d86639e-03a8-446b-b6b7-1b2d6fbdbe7d_672cd270-b75e-44a0-b08e-c3caa210f552.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, o-toluidine,95-53-4,"According to OECD/SIDS of o-toluidine published by UNEP in 2006, repeated dose toxicity studies show that o-toluidine is markedly toxic to erythrocytes an a methemoglobin forming chemical. This was demonstrated in elevated methemoglobin levels up to 19.0 % in the subacute feeding study as well vas marked splenic toxicity in the subacute gavage and subchronic feeding studies, leading to hypercellularity in the bone marrow. Further target organs were liver and kidney (hemosiderin deposition) and urinary bladder (hyperplasia). Based on the hematological findings no NOAEL could be derived, the LOAEL (rat, 14 -day feeding study) was 500 ppm (approx. 25.5 mg/kg bw/day for males and females, respectively) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75bb8717-b4ef-4446-9a77-53d8ac496386/documents/IUC5-9f524552-c4e7-4887-8f5e-b2b0eff880fc_2d82543a-6018-474b-9e49-854cf03f1cb9.html,,,,,, o-toluidine,95-53-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75bb8717-b4ef-4446-9a77-53d8ac496386/documents/IUC5-9f524552-c4e7-4887-8f5e-b2b0eff880fc_2d82543a-6018-474b-9e49-854cf03f1cb9.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,25.5 mg/kg bw/day,,rat o-toluidine,95-53-4,acute oral toxicity: LD 50= 750 mg/ kg bw; acute inhalative toxicity: LD50= 862 ppm; acute dermal toxicity: LD50=3250 mg/kg bw ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75bb8717-b4ef-4446-9a77-53d8ac496386/documents/IUC5-ced4e05f-525f-4218-817a-abc484b39ae8_2d82543a-6018-474b-9e49-854cf03f1cb9.html,,,,,, o-toluidine,95-53-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75bb8717-b4ef-4446-9a77-53d8ac496386/documents/IUC5-ced4e05f-525f-4218-817a-abc484b39ae8_2d82543a-6018-474b-9e49-854cf03f1cb9.html,,oral,LD50,750 mg/kg bw,adverse effect observed, o-toluidine,95-53-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75bb8717-b4ef-4446-9a77-53d8ac496386/documents/IUC5-ced4e05f-525f-4218-817a-abc484b39ae8_2d82543a-6018-474b-9e49-854cf03f1cb9.html,,dermal,LD50,"3,250 mg/kg bw",adverse effect observed, o-toluidine,95-53-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75bb8717-b4ef-4446-9a77-53d8ac496386/documents/IUC5-ced4e05f-525f-4218-817a-abc484b39ae8_2d82543a-6018-474b-9e49-854cf03f1cb9.html,,inhalation,LC50,"3,827 mg/m3",adverse effect observed, "Pitch, coal tar, high-temp.",65996-93-2,"No experimental repeated-dose toxicity data is available on pitch, coal tar, high-temp. itself. A related coal-tar material containing also constituents present in CTPht produced no particular, treatment-related toxicity in male and female mice receiving the test material in the feed for up to 6 months. The NOAEL, 0.5 % in the diet, is estimated to correspond to approximately 400 mg/kg bw/d. Early not verifiable reports indicate that young pigs may have a significant lower tolerance to ingested coal-tar pitch or coal tar than the adult animals. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57e0f0de-35d3-4534-a52d-7917e24dd14c/documents/IUC5-f06ce60e-4646-4ce9-a2d7-8f74e211a15f_1bbea282-a8ac-48d0-be8e-891f1745aa26.html,,,,,, "Pitch, coal tar, high-temp.",65996-93-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57e0f0de-35d3-4534-a52d-7917e24dd14c/documents/IUC5-f06ce60e-4646-4ce9-a2d7-8f74e211a15f_1bbea282-a8ac-48d0-be8e-891f1745aa26.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat "Pitch, coal tar, high-temp.",65996-93-2," No particular acute toxicity was noted in experimental studies. Oral LD50 was > 15000 mg/kg bw, while dermal LD50 was > 2000 mg/kg bw (limit tests, species rat). In both studies, no mortality or signs of systemic toxicity were observed. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57e0f0de-35d3-4534-a52d-7917e24dd14c/documents/IUC5-3e3f9ded-1d32-4c1b-a21b-3b3c57317db0_1bbea282-a8ac-48d0-be8e-891f1745aa26.html,,,,,, "Pitch, coal tar, high-temp.",65996-93-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57e0f0de-35d3-4534-a52d-7917e24dd14c/documents/IUC5-3e3f9ded-1d32-4c1b-a21b-3b3c57317db0_1bbea282-a8ac-48d0-be8e-891f1745aa26.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "Pitch, coal tar, high-temp.",65996-93-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57e0f0de-35d3-4534-a52d-7917e24dd14c/documents/IUC5-3e3f9ded-1d32-4c1b-a21b-3b3c57317db0_1bbea282-a8ac-48d0-be8e-891f1745aa26.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,6-xylidine",87-62-7," oral In a subacute and a subchronic study within the framework of the NTP carcinogenicity Study, F344 rats treated with 2,6-xylidine by gavage for 2 or 13 weeks developed haematological alterations (NTP, 1990). Male rats were more sensitive than females. After 2 weeks, anisocytosis, poikilocytosis, and polychromasia of red blood cells, a generalised leukocytosis and a decrease in body weight gain were observed at 310 mg/kg bw/d. After 13 weeks, total leukocyte counts were significantly decreased at 40 mg/kg bw/d, additional haematological changes (decrease of lymphocyte and increase in neutrophil counts, decrease of haemoglobin level, red blood cell count and haematocrit) were observed at higher concentrations. However, the decreases in red blood parameters were not severe enough to be considered as anaemia an no noteworthy clinical signs or histopathological effects were observed. The NOAEL was determined to be 160 mg/kg bw/d based on effects on haematological parameters and organ weights.   dermal No information available.   inhalation No information available. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfa14d3f-308f-4578-9ec2-2a91e2e4075b/documents/IUC5-c8791fe9-8ef2-41fe-97df-6b9b2bd54a8f_03c43bfb-6be7-423a-b75c-8f7801818ea2.html,,,,,, "2,6-xylidine",87-62-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfa14d3f-308f-4578-9ec2-2a91e2e4075b/documents/IUC5-c8791fe9-8ef2-41fe-97df-6b9b2bd54a8f_03c43bfb-6be7-423a-b75c-8f7801818ea2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,160 mg/kg bw/day,,rat "2,6-xylidine",87-62-7," Acute oral toxicity - Rat: LD50 = 840 - 1230 mg/kg bw [Jacobson et al., 1972; NTP, 1990; Vernot et al., 1977] - Mouse: LD50 = 710 mg/kg bw [Vernot et al., 1977]. Acute Inhalation toxicity - Rat: LC50 > 0.75 mg/L (Inhalation Hazard Test, 7h, saturated vapour) [BASF, 1982]. Acute Dermal toxicity - No data available. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfa14d3f-308f-4578-9ec2-2a91e2e4075b/documents/IUC5-586001a4-18bd-42b0-ac27-2f962b2cbfdf_03c43bfb-6be7-423a-b75c-8f7801818ea2.html,,,,,, "2,6-xylidine",87-62-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfa14d3f-308f-4578-9ec2-2a91e2e4075b/documents/IUC5-586001a4-18bd-42b0-ac27-2f962b2cbfdf_03c43bfb-6be7-423a-b75c-8f7801818ea2.html,,oral,LD50,"1,230 mg/kg bw",adverse effect observed, "2,6-xylidine",87-62-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfa14d3f-308f-4578-9ec2-2a91e2e4075b/documents/IUC5-586001a4-18bd-42b0-ac27-2f962b2cbfdf_03c43bfb-6be7-423a-b75c-8f7801818ea2.html,,inhalation,LC50,750 mg/m3,no adverse effect observed, "Lead 2,4,6-trinitro-m-phenylene dioxide",15245-44-0,"Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58e19b0e-9ec7-480f-815c-9bb678691db5/documents/IUC5-0f0aad1a-260e-4698-b503-a5c395ef90bf_e720cfaf-7879-4c38-adda-cbe8f4f23177.html,,,,,, "Lead 2,4,6-trinitro-m-phenylene dioxide",15245-44-0,Inorganic lead compounds do not exhit toxicity in acute toxicity tests with experimental animals. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58e19b0e-9ec7-480f-815c-9bb678691db5/documents/IUC5-abaf7827-a20a-40a6-b5a5-8d85d0e2df01_e720cfaf-7879-4c38-adda-cbe8f4f23177.html,,,,,, "2,4-xylidine",95-68-1,"Inhalation:NOEC (4 weeks, 6h/d, whole body, male/female rat): 0.033 mg/LOral:NOAEL (20 days, gavage, male rat): < 117 mg/kg bw/dNOAEL (4 weeks, gavage, male/female rat): < 500 mg/kg bw/dNOAEL (28 days, gavage, male/female rat): 20 mg/kg bw/dNOAEL (28 days, oral, male/female dog): 10 mg/kg bw/dNOAEL (6 months, feeding study, male/female rat): 750 ppmNOEL (10 days, oral, male dog): 25 mg/kg bw/d (study not reliable)NOAEL (10 days, gavage, male rat): < 117 mg/kg bw/d (study not reliable)NOAEL (7 days, oral, male/female rat): < 400 mg/kg bw/dDermal:NOAEL (32 days, dog): < 100 mg/kg bw/d NOAEL (19 days, cat): < 100 mg/kg bw/d ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fbbc157-3538-4c71-a15d-3a362453fd93/documents/IUC5-8ebc9bd1-a17c-42ab-a656-c6d77a1ea576_d78aeae8-fef7-4617-91e2-1a4843978b44.html,,,,,, "2,4-xylidine",95-68-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fbbc157-3538-4c71-a15d-3a362453fd93/documents/IUC5-8ebc9bd1-a17c-42ab-a656-c6d77a1ea576_d78aeae8-fef7-4617-91e2-1a4843978b44.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,dog "2,4-xylidine",95-68-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fbbc157-3538-4c71-a15d-3a362453fd93/documents/IUC5-8ebc9bd1-a17c-42ab-a656-c6d77a1ea576_d78aeae8-fef7-4617-91e2-1a4843978b44.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,33 mg/m3,,rat "2,4-xylidine",95-68-1,"Oral:- male rats, LD50: 1259 mg/kg bw- rats, LD50: 2000 mg/kg bw (study not reliable)- rats, LD50: 467 mg/kg bw (study not reliable)- mice, LD50: 250 mg/kg bw (study not reliable)- mice, LD50: 1670 mg/kg bw (study not reliable)- rabbits, LD50: 1500 mg/kg bw (study not reliable)Inhalation:- male/female rats, LC50: 1.53 mg/LDermal:- dogs, LD50: > 2000 mg/kg bw- cats, LD50: < 2000 mg/kg bw- rats, LD50: 500 mg/kg bw (study not reliable) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fbbc157-3538-4c71-a15d-3a362453fd93/documents/IUC5-72ecb6d0-708c-4ec3-97a4-8ad74a987259_d78aeae8-fef7-4617-91e2-1a4843978b44.html,,,,,, "2,4-xylidine",95-68-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fbbc157-3538-4c71-a15d-3a362453fd93/documents/IUC5-72ecb6d0-708c-4ec3-97a4-8ad74a987259_d78aeae8-fef7-4617-91e2-1a4843978b44.html,,oral,LD50,"1,259 mg/kg bw",, "2,4-xylidine",95-68-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fbbc157-3538-4c71-a15d-3a362453fd93/documents/IUC5-72ecb6d0-708c-4ec3-97a4-8ad74a987259_d78aeae8-fef7-4617-91e2-1a4843978b44.html,,inhalation,LC50,"1,530 mg/m3",, "Naphtha (petroleum), light steam-cracked arom.",68527-23-1,"Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene / n-hexane - when present at 10%). Adequate information is available on the constituents to characterise the repeated dermal hazards of these streams. Adequate information is available on the constituents to characterise the repeated inhalation hazards of these streams. Adequate information is available on the constituents to characterise the repeated oral hazards of these streams. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e325021-600c-4fdd-bdf1-505ec7ebe035/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_4a09df43-17b0-43c3-86d3-77c2e97dbb95.html,,,,,, "Naphtha (petroleum), light steam-cracked arom.",68527-23-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e325021-600c-4fdd-bdf1-505ec7ebe035/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_4a09df43-17b0-43c3-86d3-77c2e97dbb95.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Naphtha (petroleum), light steam-cracked arom.",68527-23-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e325021-600c-4fdd-bdf1-505ec7ebe035/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_4a09df43-17b0-43c3-86d3-77c2e97dbb95.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Naphtha (petroleum), light steam-cracked arom.",68527-23-1,"Available data for one stream within this category (CAS 68516-20-1) and data on specific constituents (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Adequate information is available to characterise the short-term hazards of these streams. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e325021-600c-4fdd-bdf1-505ec7ebe035/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_4a09df43-17b0-43c3-86d3-77c2e97dbb95.html,,,,,, "Naphtha (petroleum), light steam-cracked arom.",68527-23-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e325021-600c-4fdd-bdf1-505ec7ebe035/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_4a09df43-17b0-43c3-86d3-77c2e97dbb95.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light steam-cracked arom.",68527-23-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e325021-600c-4fdd-bdf1-505ec7ebe035/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_4a09df43-17b0-43c3-86d3-77c2e97dbb95.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light steam-cracked arom.",68527-23-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e325021-600c-4fdd-bdf1-505ec7ebe035/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_4a09df43-17b0-43c3-86d3-77c2e97dbb95.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, "Distillates (petroleum), light thermal cracked, debutanized arom.",68955-29-3,"Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene / n-hexane - when present at 10%). Adequate information is available on the constituents to characterise the repeated dermal hazards of these streams. Adequate information is available on the constituents to characterise the repeated inhalation hazards of these streams. Adequate information is available on the constituents to characterise the repeated oral hazards of these streams. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12d66c27-77d5-45db-8ad9-b4d7a8aa2ea0/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_dd8c6d24-5f13-471a-8e21-858deb5c6a16.html,,,,,, "Distillates (petroleum), light thermal cracked, debutanized arom.",68955-29-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12d66c27-77d5-45db-8ad9-b4d7a8aa2ea0/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_dd8c6d24-5f13-471a-8e21-858deb5c6a16.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), light thermal cracked, debutanized arom.",68955-29-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12d66c27-77d5-45db-8ad9-b4d7a8aa2ea0/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_dd8c6d24-5f13-471a-8e21-858deb5c6a16.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Distillates (petroleum), light thermal cracked, debutanized arom.",68955-29-3,"Available data for one stream within this category (CAS 68516-20-1) and data on specific constituents (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Adequate information is available to characterise the short-term hazards of these streams. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12d66c27-77d5-45db-8ad9-b4d7a8aa2ea0/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_dd8c6d24-5f13-471a-8e21-858deb5c6a16.html,,,,,, "Distillates (petroleum), light thermal cracked, debutanized arom.",68955-29-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12d66c27-77d5-45db-8ad9-b4d7a8aa2ea0/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_dd8c6d24-5f13-471a-8e21-858deb5c6a16.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light thermal cracked, debutanized arom.",68955-29-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12d66c27-77d5-45db-8ad9-b4d7a8aa2ea0/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_dd8c6d24-5f13-471a-8e21-858deb5c6a16.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light thermal cracked, debutanized arom.",68955-29-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12d66c27-77d5-45db-8ad9-b4d7a8aa2ea0/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_dd8c6d24-5f13-471a-8e21-858deb5c6a16.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, Amitriptyline hydrochloride,549-18-8," LABORATORY ANIMALS: Chronic Exposure or Carcinogenicity/ Rats: 0, 15, 30 or 60 mg/kg/day were given orally by gavage, 5 days a week, for periods up to 48 weeks. Doses of 60 mg/kg/day produced a moderate depression of body weight and a slight increase in liver weight. Source: Hazardous Substances Data Bank [Internet]. Bethesda (MD): National Library of Medicine (US). Available from: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?HSDB ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/005a68ed-cceb-492e-861f-ea3923c47d60/documents/6151509c-5f15-4c84-b04c-5d440b0910b1_c8b9b488-0dcc-43cc-b272-959ed5d9c961.html,,,,,, Amitriptyline hydrochloride,549-18-8," Several acute oral toxicity values are available for Amitriptyline hydrochloride, the most relevant values are summarized below. rat, LD50, oral = 240 mg/kg mouse, LD50, oral = 140 mg/kg Overall, available data are sufficient to classify the substance as Acute Tox. 3 H301. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/005a68ed-cceb-492e-861f-ea3923c47d60/documents/de1547d0-a2d3-42c6-977b-b1fa89e79659_c8b9b488-0dcc-43cc-b272-959ed5d9c961.html,,,,,, Proxan-sodium,140-93-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Inhalation of potassium amyl xanthate produces adverse effects in the livers of dogs. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65d414d1-4ba4-43c1-bf2b-63e88c320e38/documents/6e43f327-78b4-46da-b19c-64eece80f589_b1dfc4cb-9a35-4078-af2c-f9c2e70fe310.html,,,,,, Proxan-sodium,140-93-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65d414d1-4ba4-43c1-bf2b-63e88c320e38/documents/6e43f327-78b4-46da-b19c-64eece80f589_b1dfc4cb-9a35-4078-af2c-f9c2e70fe310.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,100 mg/m3,,dog Proxan-sodium,140-93-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65d414d1-4ba4-43c1-bf2b-63e88c320e38/documents/6e43f327-78b4-46da-b19c-64eece80f589_b1dfc4cb-9a35-4078-af2c-f9c2e70fe310.html,Chronic toxicity – systemic effects,oral,LOAEL,10 mg/kg bw/day,,rat Proxan-sodium,140-93-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Note that acute oral toxicity has been assess on the range of substances and with the exception of one mouse study, all are in the Acute Toxic 4 category. The quality of the data base is considered sufficient for the purposes of classification and risk management. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65d414d1-4ba4-43c1-bf2b-63e88c320e38/documents/11bb626d-22e7-4ee4-a721-ffe9a93ac277_b1dfc4cb-9a35-4078-af2c-f9c2e70fe310.html,,,,,, Proxan-sodium,140-93-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65d414d1-4ba4-43c1-bf2b-63e88c320e38/documents/11bb626d-22e7-4ee4-a721-ffe9a93ac277_b1dfc4cb-9a35-4078-af2c-f9c2e70fe310.html,,oral,LD50,"ca.1,250 mg/kg bw",adverse effect observed, Proxan-sodium,140-93-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65d414d1-4ba4-43c1-bf2b-63e88c320e38/documents/11bb626d-22e7-4ee4-a721-ffe9a93ac277_b1dfc4cb-9a35-4078-af2c-f9c2e70fe310.html,,inhalation,LC50,"7,690 mg/m3",adverse effect observed, "Distillates (petroleum), polymd. steam-cracked petroleum distillates, C5-12 fraction",68477-50-9,"The limited repeat dose toxicity data on specific streams identified for this category (oral toxicity studies for CAS 68477-54-3 [Low Dicyclopentadiene Resin Oil] and CAS 48478-10-4 [Dicyclopentadiene/Codimer Concentrate] provided no evidence of significant target organ toxicity. However, there are substantial data on the repeated dose toxicity of a number of specific components benzene, toluene, styrene and ethylbenzene present in some streams which demonstrate significant target organ toxicity. Classification witll be required for streams that contain concentrations greater than or equal to 1% (benzene) or 10% (toluene). ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ababded-d1b5-4aab-b1b9-ddc041a5ebc4/documents/IUC5-e7643ee1-593f-455c-ac0b-500da297367a_34d11fcc-5071-4d6c-9639-7628dedfc859.html,,,,,, "Distillates (petroleum), polymd. steam-cracked petroleum distillates, C5-12 fraction",68477-50-9,"Available data for 4 specific streams within this category Cracked distillate [CAS 68477-40-7], C9 Resinfeed [CAS 68477-54-3], E000144700 [CAS 68516-20-1] and C9 Produkt [CAS 94733-07-0] and on specific components (benzene, toluene, 1,3-butadiene, naphthalene and isoprene) that are present in some streams indicate that acute toxicity is generally expected to be low. Resin Oil and Cyclic Dienes do not pose an acute hazard following skin contact (dermal LD50 > 2000 mg/kg). Two streams (E000044012 [CAS 68478-10-4], E000044146 [CAS 68478-10-4]) and the component dicyclopentadiene are considered to be hazardous following acute inhalation exposures. Streams containing a high proportion (≥25%) of dicyclopentadiene or naphthalene are expected to be hazardous following oral exposures. Styrene is hazardous following acute inhalation exposure and classification will be required for streams containing ≥12.5%. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and labelling (R67) will be required for streams containing ≥20% toluene. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ababded-d1b5-4aab-b1b9-ddc041a5ebc4/documents/IUC5-0f7838b1-4d4e-4e12-b113-3995ac4cc7ba_34d11fcc-5071-4d6c-9639-7628dedfc859.html,,,,,, "1-bromo-3,4,5-trifluorobenzene",138526-69-9," In a GLP study performed according to OECD TG 407, groups of male and female Wistar rats were dosed orally via gavage at levels of 0, 100, 300 or 1000 mg/kg once daily on 7 days per week over 4 weeks. The test item was tolerated by the rats at 100 mg/kg bw/day without toxicologically relevant effects, while dosing with >= 300 mg/kg bw/day was not tolerated due to clinical, haematological, clinico-chemical, macroscopically, and histopathological changes (reference 7.5.1 -1). ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b5bcb50-6974-43bc-8e21-50f64772cc8c/documents/a445ca4d-eed8-48f7-9422-50923581cd1b_7c2bfd2d-a7d6-4e84-969e-91fed0b126a4.html,,,,,, "1-bromo-3,4,5-trifluorobenzene",138526-69-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b5bcb50-6974-43bc-8e21-50f64772cc8c/documents/a445ca4d-eed8-48f7-9422-50923581cd1b_7c2bfd2d-a7d6-4e84-969e-91fed0b126a4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1-bromo-3,4,5-trifluorobenzene",138526-69-9, oral LD50 (male/female) > 2000 mg/kg bw (reference 7.2.1 -1) inhalative LC50 (male/female) > 22 mg/L air (reference 7.2.2 -1) ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b5bcb50-6974-43bc-8e21-50f64772cc8c/documents/ba882b50-ff99-43c8-b49a-77cc2f058379_7c2bfd2d-a7d6-4e84-969e-91fed0b126a4.html,,,,,, "1-bromo-3,4,5-trifluorobenzene",138526-69-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b5bcb50-6974-43bc-8e21-50f64772cc8c/documents/ba882b50-ff99-43c8-b49a-77cc2f058379_7c2bfd2d-a7d6-4e84-969e-91fed0b126a4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-bromo-3,4,5-trifluorobenzene",138526-69-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b5bcb50-6974-43bc-8e21-50f64772cc8c/documents/ba882b50-ff99-43c8-b49a-77cc2f058379_7c2bfd2d-a7d6-4e84-969e-91fed0b126a4.html,,inhalation,LC50,"22,000 mg/m3",adverse effect observed, "diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea",330-54-1,Studies on oral sub-chronic and chronic repeated dose toxicity were available for Diuron. Oral 90-day NOAEL for rat (males): 100 ppm (6.7 mg/kg bw/day). Oral 12-Months NOAEL for Dog: 1.8 mg/kg bw/day.Studies on dermal sub-acute repeated dose toxicity were available for Diuron. Dermal 21-days NOAEL for rabbit: 250 mg/kg bw/day.Studies on inhalation sub-acute repeated dose toxicity were available for Diuron. Inhalation 21-days NOAEC for rat: 37.4 mg/m³ for male and 4.1 mg/m³ for female. ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/932e6123-a469-4885-a367-47952e522e75/documents/IUC5-b0e8454d-6827-40b6-8026-132aa5855539_806cd46d-73fe-4e9d-8d21-17cd85465966.html,,,,,, "diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea",330-54-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/932e6123-a469-4885-a367-47952e522e75/documents/IUC5-b0e8454d-6827-40b6-8026-132aa5855539_806cd46d-73fe-4e9d-8d21-17cd85465966.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,250 mg/kg bw/day,,rabbit "diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea",330-54-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/932e6123-a469-4885-a367-47952e522e75/documents/IUC5-b0e8454d-6827-40b6-8026-132aa5855539_806cd46d-73fe-4e9d-8d21-17cd85465966.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,4.1 mg/m3,,rat "diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea",330-54-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/932e6123-a469-4885-a367-47952e522e75/documents/IUC5-b0e8454d-6827-40b6-8026-132aa5855539_806cd46d-73fe-4e9d-8d21-17cd85465966.html,Chronic toxicity – systemic effects,oral,NOAEL,1.8 mg/kg bw/day,,dog "diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea",330-54-1,"The most sensitive LD50 is 1017 mg/kg bodyweight for Diuron when administered after rats were fed regular laboratory chow diet 28 days prior to dosing. In addition, there are several reliable studies showing that the rather low toxicity of Diuron and that the toxicity, if observed, was attributed to the diet and vehicle used in the studies and not to the substance itself.All available acute inhalation studies on Diuron by the inhalation route showed no toxic effect at the tested concentrations. All available acute inhalation studies on Diuron by the dermal route showed no toxic effect at the tested concentrations. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/932e6123-a469-4885-a367-47952e522e75/documents/IUC5-b71c6aa6-8654-42ad-8c2a-ce4153efc47c_806cd46d-73fe-4e9d-8d21-17cd85465966.html,,,,,, "diuron (ISO); 3-(3,4-dichlorophenyl)-1,1-dimethylurea",330-54-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/932e6123-a469-4885-a367-47952e522e75/documents/IUC5-b71c6aa6-8654-42ad-8c2a-ce4153efc47c_806cd46d-73fe-4e9d-8d21-17cd85465966.html,,oral,LD50,"1,017 mg/kg bw",, 4-methyl-m-phenylene diisocyanate,584-84-9,"Inhalation exposure is the most appropriate route for assessing occupational risk in humans. Effects from repeated exposure of animals to TDI are limited to effects on the respiratory tract caused by local irritation, no signs of systemic toxicity were observed. The oral and dermal route of exposure are not relevant for assessment. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0021158-40ef-4709-9b19-bb212e762433/documents/IUC5-0b250ed9-69ef-4805-ab08-13daf92102dc_daaad932-56a3-4abb-b0b7-8bd4c855be8d.html,,,,,, 4-methyl-m-phenylene diisocyanate,584-84-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0021158-40ef-4709-9b19-bb212e762433/documents/IUC5-0b250ed9-69ef-4805-ab08-13daf92102dc_daaad932-56a3-4abb-b0b7-8bd4c855be8d.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,0.362 mg/m3,, 4-methyl-m-phenylene diisocyanate,584-84-9,Acute toxicity:Oral: LD50 > 2000 mg/kg for rats or mice (following or equivalent to OECD TG 401)Dermal: LD50 > 2000 mg/kg for rabbits (equivalent to OECD TG 402)Inhalation: LC50 = 0.48 mg/l/1 hr for rats (equivalent to OECD TG 403) ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0021158-40ef-4709-9b19-bb212e762433/documents/IUC5-a7ff5d6b-d6fc-409c-8cee-c77a657e0ff7_daaad932-56a3-4abb-b0b7-8bd4c855be8d.html,,,,,, Chlorine,7782-50-5,"Oral:No studies for oral toxicity are available for chlorine. Chlorine is handled in closed systems exclusively and an exposure to the gas is only accidentally. The only possible exposure is via inhalation. Repeated dose studies with sodium hypochlorite were conducted. Thus a read across is done from sodium hypochlorite. Study 1 (Hasegawa et al., 1986):There were no mortalities throughout a 90 day study with rats. Body weight gain was statistically significantly reduced in males at 100 and 120 mg av Cl/kg bw/day dose level groups and in females at 228.8 mg av Cl/kg bw/day dose level group; there were no obvious macroscopic or histological changes in any group. A NOAEL of 50 mg/kg bw/day was identified.Study 2 (Daniel et al., 1990):In a 90 day study with rats up to concentrations of 16.7 mg Cl/kg bw/day, no significant differences between treated and control groups apart from sporadic deviations in haematological and clinical chemistry parameters, which were considered not to be treatment related.Study 3 (Daniel et al., 1991):In general, treated mice (90 days up to concentrations of 34 mg Cl/kg bw/day) exhibited a decreased water consumption and a decreased weight gain. Haematology, clinical chemistry and necropsy revealed some alterations in mice that received chlorinated water: animals of the highest concentration groups had lower enzyme activities consistent with lower liver weights. Overall, the effects are considered to be mild, non-specific, transient and secondary to e.g. nutritional deficiencies due to taste aversion of the drinking water.Inhalation:No systemic effects were observed in repeated dose exposure studies in rats, mice and monkeys with chlorine gas. Additionally, chlorine was discussed by SCOEL and an OEL of 0.5 ppm (1.5 mg/m3) was agreed based on these studies, with removal of the 8-hour TWA. The justification was that the effects appear to be related to concentration in the air and not to duration of exposure. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa7dbef7-dc18-46d3-a0a9-41470fe8e793/documents/IUC5-c551c50c-8ed4-4dc6-a71d-2e6b9137f10d_1587a943-5d9c-4ddc-b7cb-63bdf400dba2.html,,,,,, Chlorine,7782-50-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa7dbef7-dc18-46d3-a0a9-41470fe8e793/documents/IUC5-c551c50c-8ed4-4dc6-a71d-2e6b9137f10d_1587a943-5d9c-4ddc-b7cb-63bdf400dba2.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,1.5 mg/m3,, Chlorine,7782-50-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa7dbef7-dc18-46d3-a0a9-41470fe8e793/documents/IUC5-c551c50c-8ed4-4dc6-a71d-2e6b9137f10d_1587a943-5d9c-4ddc-b7cb-63bdf400dba2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Chlorine,7782-50-5,"Oral:No specific studies are available with chlorine gas. Read across from sodium hypochlorite is performed instead. The acute toxicity of marketed hypochlorite solutions by the oral route is low. The LD50 values for solutions containing active chlorine concentrations up to 12.5 % are greater than 5.8 g/kg. Human data following accidental exposure to household bleaches are reported for the ingestion and parenteral routes: it can be concluded that the effects of accidental ingestion of domestic sodium hypochlorite bleaches are not expected to lead to severe or permanent damage of the gastrointestinal tract as recovery is rapid and without any permanent health consequences. This is also expected for small quantities of solutions accidentally injected into the blood system or in the tissues. Although the overall lowest LD50 available is from a study by Momma et al (1986), it is preferred to use the value from the study by Kaestner et al (1981) as the key reference study because the data is considered of higher reliability, and it is based on the rat, the standard animal. The LD50 and LD0 values were calculated as follows:LD50= 12.5% (% of available Cl2 in sol.) x 8.83 (g/kg BW LD50 of the sol. to male rat) = 1.1 g/kg BW (LD50 as available Cl2) = 1100 mg/kg BW NaClO as av. Cl2LD0= 12.5% (% of available Cl2 in sol.) x 5.01 (g/kg LD50 of the sol. to male rat) 0.626 g/kg BW (LD50 as available Cl2) = 626 mg/kg BW NaClO as av. Cl2Dermal:No specific studies are available with chlorine gas. Read across from sodium hypochlorite is performed instead. In an acute dermal toxicity study, animals showed signs of moderate to severe skin irritation. The dermal LD50 was determined to be greater than 20 g/kg bw (12.5% aqueous solution).Inhalation:In the acute inhalation toxicity study in Wistar rats (Zwart, 1987) conducted with chlorine, ... ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa7dbef7-dc18-46d3-a0a9-41470fe8e793/documents/IUC5-21308c98-2856-431b-9adb-638e70060806_1587a943-5d9c-4ddc-b7cb-63bdf400dba2.html,,,,,, Chlorine,7782-50-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa7dbef7-dc18-46d3-a0a9-41470fe8e793/documents/IUC5-21308c98-2856-431b-9adb-638e70060806_1587a943-5d9c-4ddc-b7cb-63bdf400dba2.html,,oral,LD50,"1,100 mg/kg bw",, Chlorine,7782-50-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa7dbef7-dc18-46d3-a0a9-41470fe8e793/documents/IUC5-21308c98-2856-431b-9adb-638e70060806_1587a943-5d9c-4ddc-b7cb-63bdf400dba2.html,,dermal,LD50,"20,000 mg/kg bw",, Chlorine,7782-50-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa7dbef7-dc18-46d3-a0a9-41470fe8e793/documents/IUC5-21308c98-2856-431b-9adb-638e70060806_1587a943-5d9c-4ddc-b7cb-63bdf400dba2.html,,inhalation,LC50,0.65 mg/m3,, "Distillates (petroleum), heavy catalytic cracked",64741-61-3," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0c2c3c9-562d-4dfc-8e64-b30a34091749/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_ff3a6ab0-4616-4231-b29f-fbe93ae0a8b6.html,,,,,, "Distillates (petroleum), heavy catalytic cracked",64741-61-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0c2c3c9-562d-4dfc-8e64-b30a34091749/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_ff3a6ab0-4616-4231-b29f-fbe93ae0a8b6.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Distillates (petroleum), heavy catalytic cracked",64741-61-3,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0c2c3c9-562d-4dfc-8e64-b30a34091749/documents/12190120-6b6e-49c5-bed7-264eab246437_ff3a6ab0-4616-4231-b29f-fbe93ae0a8b6.html,,,,,, "Distillates (petroleum), heavy catalytic cracked",64741-61-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0c2c3c9-562d-4dfc-8e64-b30a34091749/documents/12190120-6b6e-49c5-bed7-264eab246437_ff3a6ab0-4616-4231-b29f-fbe93ae0a8b6.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Distillates (petroleum), heavy catalytic cracked",64741-61-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0c2c3c9-562d-4dfc-8e64-b30a34091749/documents/12190120-6b6e-49c5-bed7-264eab246437_ff3a6ab0-4616-4231-b29f-fbe93ae0a8b6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), heavy catalytic cracked",64741-61-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0c2c3c9-562d-4dfc-8e64-b30a34091749/documents/12190120-6b6e-49c5-bed7-264eab246437_ff3a6ab0-4616-4231-b29f-fbe93ae0a8b6.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "Distillates (petroleum), solvent-refined heavy paraffinic",64741-88-4,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5115ba16-90f6-497a-b165-d60df0587345/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_bb6f4ff9-b7f3-4fb2-90ae-8c2469ce6d03.html,,,,,, "Distillates (petroleum), solvent-refined heavy paraffinic",64741-88-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5115ba16-90f6-497a-b165-d60df0587345/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_bb6f4ff9-b7f3-4fb2-90ae-8c2469ce6d03.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Distillates (petroleum), solvent-refined heavy paraffinic",64741-88-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5115ba16-90f6-497a-b165-d60df0587345/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_bb6f4ff9-b7f3-4fb2-90ae-8c2469ce6d03.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Distillates (petroleum), solvent-refined heavy paraffinic",64741-88-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5115ba16-90f6-497a-b165-d60df0587345/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_bb6f4ff9-b7f3-4fb2-90ae-8c2469ce6d03.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Distillates (petroleum), solvent-refined heavy paraffinic",64741-88-4,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5115ba16-90f6-497a-b165-d60df0587345/documents/73761dae-46d6-428e-8e40-e5cc70088d96_bb6f4ff9-b7f3-4fb2-90ae-8c2469ce6d03.html,,,,,, "Distillates (petroleum), solvent-refined heavy paraffinic",64741-88-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5115ba16-90f6-497a-b165-d60df0587345/documents/73761dae-46d6-428e-8e40-e5cc70088d96_bb6f4ff9-b7f3-4fb2-90ae-8c2469ce6d03.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), solvent-refined heavy paraffinic",64741-88-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5115ba16-90f6-497a-b165-d60df0587345/documents/73761dae-46d6-428e-8e40-e5cc70088d96_bb6f4ff9-b7f3-4fb2-90ae-8c2469ce6d03.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), solvent-refined heavy paraffinic",64741-88-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5115ba16-90f6-497a-b165-d60df0587345/documents/73761dae-46d6-428e-8e40-e5cc70088d96_bb6f4ff9-b7f3-4fb2-90ae-8c2469ce6d03.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Naphtha (petroleum), steam-cracked middle arom.",68516-20-1,"After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and in humans. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f3749b0-0348-4a82-a2f6-e03fda5a887a/documents/0a65e697-ca75-4710-87c1-abe636e0b74a_27ab4798-ed01-4d02-b103-ec0bcf63941d.html,,,,,, "Naphtha (petroleum), steam-cracked middle arom.",68516-20-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f3749b0-0348-4a82-a2f6-e03fda5a887a/documents/0a65e697-ca75-4710-87c1-abe636e0b74a_27ab4798-ed01-4d02-b103-ec0bcf63941d.html,Chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Naphtha (petroleum), steam-cracked middle arom.",68516-20-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f3749b0-0348-4a82-a2f6-e03fda5a887a/documents/0a65e697-ca75-4710-87c1-abe636e0b74a_27ab4798-ed01-4d02-b103-ec0bcf63941d.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human (epidemiological findings) "Naphtha (petroleum), steam-cracked middle arom.",68516-20-1," Benzene does not pose an acute hazard following ingestion (oral LD50 > 2000 mg/kg), skin contact (dermal LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f3749b0-0348-4a82-a2f6-e03fda5a887a/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_27ab4798-ed01-4d02-b103-ec0bcf63941d.html,,,,,, "Naphtha (petroleum), steam-cracked middle arom.",68516-20-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f3749b0-0348-4a82-a2f6-e03fda5a887a/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_27ab4798-ed01-4d02-b103-ec0bcf63941d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), steam-cracked middle arom.",68516-20-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f3749b0-0348-4a82-a2f6-e03fda5a887a/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_27ab4798-ed01-4d02-b103-ec0bcf63941d.html,,dermal,LD50,"8,260 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), steam-cracked middle arom.",68516-20-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f3749b0-0348-4a82-a2f6-e03fda5a887a/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_27ab4798-ed01-4d02-b103-ec0bcf63941d.html,,inhalation,LC50,"43,767 mg/m3",no adverse effect observed, "Naphtha (petroleum), light straight-run",64741-46-4,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ea5553a-926a-40e0-8c47-983a0a94ee92/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_62d2ef43-8a2c-4878-b9ed-4ef9c544f352.html,,,,,, "Naphtha (petroleum), light straight-run",64741-46-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ea5553a-926a-40e0-8c47-983a0a94ee92/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_62d2ef43-8a2c-4878-b9ed-4ef9c544f352.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), light straight-run",64741-46-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ea5553a-926a-40e0-8c47-983a0a94ee92/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_62d2ef43-8a2c-4878-b9ed-4ef9c544f352.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), light straight-run",64741-46-4," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ea5553a-926a-40e0-8c47-983a0a94ee92/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_62d2ef43-8a2c-4878-b9ed-4ef9c544f352.html,,,,,, "Naphtha (petroleum), light straight-run",64741-46-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ea5553a-926a-40e0-8c47-983a0a94ee92/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_62d2ef43-8a2c-4878-b9ed-4ef9c544f352.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light straight-run",64741-46-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ea5553a-926a-40e0-8c47-983a0a94ee92/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_62d2ef43-8a2c-4878-b9ed-4ef9c544f352.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light straight-run",64741-46-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ea5553a-926a-40e0-8c47-983a0a94ee92/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_62d2ef43-8a2c-4878-b9ed-4ef9c544f352.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent exts.",68410-71-9,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb73110c-dcb5-4738-8d26-c0bce57665ef/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_8f407943-6058-4d53-a322-026b209c71cd.html,,,,,, "Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent exts.",68410-71-9,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb73110c-dcb5-4738-8d26-c0bce57665ef/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_8f407943-6058-4d53-a322-026b209c71cd.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent exts.",68410-71-9,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb73110c-dcb5-4738-8d26-c0bce57665ef/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_8f407943-6058-4d53-a322-026b209c71cd.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent exts.",68410-71-9,"The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401)Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions)Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb73110c-dcb5-4738-8d26-c0bce57665ef/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_8f407943-6058-4d53-a322-026b209c71cd.html,,,,,, "Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent exts.",68410-71-9,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb73110c-dcb5-4738-8d26-c0bce57665ef/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_8f407943-6058-4d53-a322-026b209c71cd.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent exts.",68410-71-9,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb73110c-dcb5-4738-8d26-c0bce57665ef/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_8f407943-6058-4d53-a322-026b209c71cd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Raffinates (petroleum), catalytic reformer ethylene glycol-water countercurrent exts.",68410-71-9,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb73110c-dcb5-4738-8d26-c0bce57665ef/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_8f407943-6058-4d53-a322-026b209c71cd.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "2,2,2-trichloroethane-1,1-diol",302-17-0," Repeated dose toxicity: oral NOAEL was considered to be 14.4 mg/kg bw/day in male mice when exposed to Chloral Hydrate for 14 days by (oral) gavage. Repeated dose toxicity: inhalation Data available for acute toxicity by the inhalation route does not indicate inhlation toxicity in short term study. Also according to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking intoaccount the particle size distribution of the substance the majority of the particles were found to be in the size of 150 micrometer which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical chloral hydrate is highly unlikely. Therefore this study is considered for waiver. Repeated dose toxicity: dermal The acute toxicity value for chloral hydrate(as provided in section 7.2.3) is >2000 mg/kg body weight. Also considering the use of chloral hydrate as a medicine for sedation/hypnotic adverse effect by repeated exposure by the dermal route is highly unlikely. In addition, there is no data available that suggests that chloral hydrate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60ff58f8-fc4f-4fe3-bc25-67652a2e5047/documents/IUC5-10f24f74-4210-4218-8ca2-e75458edbdb9_07fd30fa-50d4-4b00-874a-8402b1fdc28c.html,,,,,, "2,2,2-trichloroethane-1,1-diol",302-17-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60ff58f8-fc4f-4fe3-bc25-67652a2e5047/documents/IUC5-10f24f74-4210-4218-8ca2-e75458edbdb9_07fd30fa-50d4-4b00-874a-8402b1fdc28c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,14.4 mg/kg bw/day,,mouse "2,2,2-trichloroethane-1,1-diol",302-17-0," Acute toxicity oral: Acute oral LD50 value for the test compound Chloral hydrate in random bred  CD1- male mice is 1442 mg/kg/bw  with 95% C.I. (1290-1605  mg/kg/bw ) and 1265  mg/kg/bw  with 95% C.I. (1097-1405 mg/Kg/bw) in female mice. Acute toxicity of chloral hydrate to rat by oral (gavage) route indicates that chloral hydrate is likely to exhibit acute toxicity by the oral route in Toxicity Category IV as per the CLP classification criteria. However, the chemical has harmonized classification as Acute toxicity 3 (oral route) and this dossier agrees to the harmonized classification as per the CLP regulation. Acute toxicity inhalation: The LC50 for the given test material Chloral Hydrate is found to be >100 ppm (>603mg/m3). This value indicates that the substance is not toxic via inhalation route and thus considered as Not classified for Acute toxicity inhalataion as per CLP classification criteria. Acute toxicity dermal: The acute dermal LD50 value of the substance Chloral Hydrate was determined to be 3030 mg/kg bw for rats. This value indicates that the substance is not toxic via dermal route of exposure and hence is considered as Not classified for acute dermal toxicity as per CLP classification criteria. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60ff58f8-fc4f-4fe3-bc25-67652a2e5047/documents/IUC5-6bc280e5-dfe1-4f09-892f-4313048efcd2_07fd30fa-50d4-4b00-874a-8402b1fdc28c.html,,,,,, "2,2,2-trichloroethane-1,1-diol",302-17-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60ff58f8-fc4f-4fe3-bc25-67652a2e5047/documents/IUC5-6bc280e5-dfe1-4f09-892f-4313048efcd2_07fd30fa-50d4-4b00-874a-8402b1fdc28c.html,,oral,LD50,"1,265 mg/kg bw",adverse effect observed, "2,2,2-trichloroethane-1,1-diol",302-17-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60ff58f8-fc4f-4fe3-bc25-67652a2e5047/documents/IUC5-6bc280e5-dfe1-4f09-892f-4313048efcd2_07fd30fa-50d4-4b00-874a-8402b1fdc28c.html,,dermal,LD50,"3,030 mg/kg bw",no adverse effect observed, "2,2,2-trichloroethane-1,1-diol",302-17-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60ff58f8-fc4f-4fe3-bc25-67652a2e5047/documents/IUC5-6bc280e5-dfe1-4f09-892f-4313048efcd2_07fd30fa-50d4-4b00-874a-8402b1fdc28c.html,,inhalation,LC50,603 mg/m3,no adverse effect observed, "Distillates (petroleum), hydrodesulfurized middle coker",101316-59-0,"No repeat dose toxicity studies have been identified for cracked gas oils, following inhalation or oral exposure. The sub-chronic inhalation study of diesel fuel (OECD 413, a read-across study from VGO/HGO/Distillate Fuels) resulted in a conservative sub-chronic NOAEC of 0.88 mg/L determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of ≥1.71 mg/L was established for systemic effects, based on no significant findings at this level.In a 28-day sub-acute study (OECD 410), dermal exposure to a light catalytically cracked distillate resulted in limited systemic changes and a NOAEL of 500 mg/kg body weight/day.  In a 90-day sub-chronic study (OECD 411), dermal exposure to light catalytically cracked distillate resulted in a systemic NOAEL of 25 mg/kg body weight/day for males, and 125 mg/kg body weight/day for females, based upon reductions in thymus weight.  In another 90-day sub-chronic study (OECD 411), dermal exposure to coker light gas oil resulted in a systemic LOAEL of 30 mg/kg body weight/day for males and females, based upon clinical signs and irritation noted at all doses. ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e80c515-2091-4cfe-b50e-93ca39d774cb/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_0ac6c568-bd9f-495d-b35c-54bfdeff5f38.html,,,,,, "Distillates (petroleum), hydrodesulfurized middle coker",101316-59-0,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e80c515-2091-4cfe-b50e-93ca39d774cb/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_0ac6c568-bd9f-495d-b35c-54bfdeff5f38.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), hydrodesulfurized middle coker",101316-59-0,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e80c515-2091-4cfe-b50e-93ca39d774cb/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_0ac6c568-bd9f-495d-b35c-54bfdeff5f38.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Distillates (petroleum), hydrodesulfurized middle coker",101316-59-0,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e80c515-2091-4cfe-b50e-93ca39d774cb/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_0ac6c568-bd9f-495d-b35c-54bfdeff5f38.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Distillates (petroleum), hydrodesulfurized middle coker",101316-59-0,"Acute Oral Toxicity:Acute oral toxicity of cracked gas oils was evaluated in male and female rats by a single oral gavage administration of a dose ranging from 2050 to 6250 mg/kg body weight.  Based on mortality and toxicity findings, an oral LD50 of 4660 mg/kg body weight and 3200 mg/kg body weight were reported for males and females, respectively.  Acute Inhalation Toxicity:Acute inhalation toxicity of cracked gas oils in rats was evaluated via whole-body exposure to test material at various measured concentrations for 4 hours.  The acute inhalation LC50 was 4.65 mg/L in males and females. Acute Dermal Toxicity:Acute dermal toxicity of cracked gas oils was evaluated in male and female rabbits at a single dose of 2000 mg/kg body weight.  Based on a lack of adverse systemic effects or mortality, the acute dermal LD50 for light catalytically cracked distillate was >2000 mg/kg body weight.   ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e80c515-2091-4cfe-b50e-93ca39d774cb/documents/61f4e539-9411-462c-acca-769cdd71de1b_0ac6c568-bd9f-495d-b35c-54bfdeff5f38.html,,,,,, "Distillates (petroleum), hydrodesulfurized middle coker",101316-59-0,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e80c515-2091-4cfe-b50e-93ca39d774cb/documents/61f4e539-9411-462c-acca-769cdd71de1b_0ac6c568-bd9f-495d-b35c-54bfdeff5f38.html,,oral,LD50,"3,200 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrodesulfurized middle coker",101316-59-0,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e80c515-2091-4cfe-b50e-93ca39d774cb/documents/61f4e539-9411-462c-acca-769cdd71de1b_0ac6c568-bd9f-495d-b35c-54bfdeff5f38.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrodesulfurized middle coker",101316-59-0,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e80c515-2091-4cfe-b50e-93ca39d774cb/documents/61f4e539-9411-462c-acca-769cdd71de1b_0ac6c568-bd9f-495d-b35c-54bfdeff5f38.html,,inhalation,LC50,"4,650 mg/m3",adverse effect observed, "Aromatic hydrocarbons, C6-10, C8-rich",90989-41-6," Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene - when present at 10%; n-hexane - when present at 5%). ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bffa8bb3-b934-4ea7-95b1-86bedda7756b/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_6c83ffb0-34d4-434d-8515-2592411c75dc.html,,,,,, "Aromatic hydrocarbons, C6-10, C8-rich",90989-41-6,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bffa8bb3-b934-4ea7-95b1-86bedda7756b/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_6c83ffb0-34d4-434d-8515-2592411c75dc.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Aromatic hydrocarbons, C6-10, C8-rich",90989-41-6,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bffa8bb3-b934-4ea7-95b1-86bedda7756b/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_6c83ffb0-34d4-434d-8515-2592411c75dc.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Aromatic hydrocarbons, C6-10, C8-rich",90989-41-6," Available data for one stream within this category (CAS 68516-20-1) and data on specific components (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bffa8bb3-b934-4ea7-95b1-86bedda7756b/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_6c83ffb0-34d4-434d-8515-2592411c75dc.html,,,,,, "Aromatic hydrocarbons, C6-10, C8-rich",90989-41-6,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bffa8bb3-b934-4ea7-95b1-86bedda7756b/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_6c83ffb0-34d4-434d-8515-2592411c75dc.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Aromatic hydrocarbons, C6-10, C8-rich",90989-41-6,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bffa8bb3-b934-4ea7-95b1-86bedda7756b/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_6c83ffb0-34d4-434d-8515-2592411c75dc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aromatic hydrocarbons, C6-10, C8-rich",90989-41-6,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bffa8bb3-b934-4ea7-95b1-86bedda7756b/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_6c83ffb0-34d4-434d-8515-2592411c75dc.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, Mesterolone,1424-00-6,"Oral, 52 weeks (Rat-Sprague-Dawley, non-GLP, doses: 0/ 0.6/ 6.0/ 20.0 mg/kg, once daily): NOEL < 0.6 mg/kg[Schering AG, report dated 1967-12-30]Oral, 52 weeks (Dog-Beagle, non-GLP, doses: 0/ 0.6/ 3.6/ 10 mg/kg, once daily): NOEL < 0.6 mg/kg[Schering AG, report dated 1967-11-30] ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/415d1348-d4d2-49bc-bba9-8328d72dc490/documents/IUC5-a4fe5a9c-efa9-4411-8c13-9c91422af4fa_cbd83703-ae1b-4dfe-8d27-25a7d5ff2daa.html,,,,,, Mesterolone,1424-00-6,"Oral (Mouse-NMRI, non-GLP): LD50 > 4000 mg/kg[Schering AG, report dated 1968-01-10]Subcutaneous (Mouse-NMRI, non-GLP): LD50 > 4000 mg/kg[Schering AG, report dated 1968-01-10]Intraperitoneal (Mouse-NMRI, non-GLP): LD50 > 4000 mg/kg[Schering AG, report dated 1968-01-10]Oral (Rat-Wistar, non-GLP): LD50 > 5000 mg/kg (aqueous suspension)[Schering AG, report dated 1968-05-16]Oral (Rat-Wistar, non-GLP): LD50 > 5000 mg/kg (oily solution)[Schering AG, report dated 1968-05-16]Oral (Dog-Beagle, non-GLP): LD50 > 1000 mg/kg[Schering AG, Report No. 1498; 1974-10-28]Intravenous (Monkey-Cynomolgus, non-GLP): LD50 > 1 mg/kg[Schering AG, Report No. 6154; 1984-07-24] ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/415d1348-d4d2-49bc-bba9-8328d72dc490/documents/IUC5-d2508a0e-233c-45fd-a165-ad9cd69a0196_cbd83703-ae1b-4dfe-8d27-25a7d5ff2daa.html,,,,,, Estrone,53-16-7,"Estradiol-17ß is the most active naturally occuring estrogenic hormone. Estradiol and its metabolite estrone are essential for the growth and normal maintenance of the lining of the uterus, for the development of the accessory and secondary female sex characteristics, and for pregnancy. The toxic effects of steroidal estrogens like estradiol <-> estrone are an exaggeration of the normal pharmacological effects and result in an increase of female characteristics. Estradiol and estrone are widely used for oral contraception and in post-menopausal hormonal therapy. Therefore a wide base of case reports is available pointing out various types of adverse effects. The most frequent adverse dermatologic reaction associated with estrogen therapy is chloasma, melasma and erythema. An increased risk of thromboembolic and thrombotic disorders including thrombophlebitis, pulmonary embolism, stroke, subarachnoid hemorrhage, and myocardial infarction was reported for the use as oral contraceptive as well as breakthrough bleeding, spotting, changes in menstrual flow, missed menses (during use), or amenorrhea (after use). Dysmenorrhea and a premenstrual-like syndrome also occurred.   No repeated dose toxicity studies were conducted with estrone. But data on estradiol can be also used for the toxicological characterization, because estrone is the major metabolite of estradiol. Thus for repeated dose toxicity results of studies conducted with estradiol are taken as surrogate of estrone to fulfill formally the standard information requirement. Since the first introduction of drug preparations containing this steroidal estrogen dates back more than five decades, the major part of its preclinical characterization does not fulfil the requirements applicable today to studies used for safety assessment. However, these limitations are more than compensated for by the vast amount of clinical experience gained with estradiol <-> estrone in their continued and widespread therapeutic use. Therefore in conclusion the results of the preclinical characterisation of estradiol <-> estrone confirm its properties as a steroidal estrogen but they are not used for the safety assessment (systemic/local effects). The dose desriptor starting point is taken from human experience.   As known from an extensive data base animal experiments with estrogens are only of limited predictive value for qualitative and even more for quanatitative extrapolation tu humans because of a large diversity in factors responsible for endocrine regulation between experimental animals and man. Therefore the most sensitive endpoint to consider is the lowest oral daily dose with pharmacological effects in humans (SSTmin) of estradiol which is used as surrogate for estrone.     - study conducted according to Guidelines for Toxicity Studies of Drugs (PAB/ERD-1, Notification no. 24, dated 11 Sep 1989), result: LOEL (females) = 0.4 mg/kg bw (Read-Across) - study with a repeated oral exposure of 5 days in rats at 20 and 300 mg/kg bw/day, result: NOAEL = 300 mg/kg bw/d (Read-Across) - published data from Gaspard et al. (1999), clinical trial with healthy menopausal women, duration 2 years, exposure: a cyclical combination of micronized estradiol 2 mg/day continuously and dydrogesterone 10 mg/day for 14 days out of each 28-day treatment cycle, results: micronized estradiol administered for 2 years to menopausal women does not cause either glucose tolerance or insulin sensitivity to deteriorate. (Read-Across) - published data from Setnikar et al. (1996), oral administration of estradiol (2mg/tablet) for 21 days, determination of estradiol and estrone in serum, results:During the administration of the Tablets, one subject complained of mild and another of severe headache, and one about hot flushes. These adverse events were classified as possibly related to treatment and did not require the withdrawal of the therapy. No other adverse effects were reported. (Read-Across) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/966d8608-3408-4140-94e5-dfdd88eb1595/documents/IUC5-06eedcd6-c010-4a5a-b0ff-8075d05c4e24_78310955-38c5-4eda-b5fb-5876e2ec88b3.html,,,,,, Estrone,53-16-7,"- study conducted according to OECD test guideline 423, result: LD50 > 2000 mg/kg bw (Read-Across) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/966d8608-3408-4140-94e5-dfdd88eb1595/documents/IUC5-f956351f-4e6e-48b4-8bf2-a809178018fe_78310955-38c5-4eda-b5fb-5876e2ec88b3.html,,,,,, Estrone,53-16-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/966d8608-3408-4140-94e5-dfdd88eb1595/documents/IUC5-f956351f-4e6e-48b4-8bf2-a809178018fe_78310955-38c5-4eda-b5fb-5876e2ec88b3.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium dichromate,10588-01-9," Repeated dose toxicity: oral Five weight of evidence studies for this endpoint are available. Two of these studies were conducted with sodium dichromate and three with potassium dichromate. Based on the information available from these five weight of evidence studies, it was concluded using a category read-across concept that the formal data requirments are fulfilled. The approach for read-across is described in detail in the document attached in IUCLID section 13. Repeated dose toxicity: inhalation No key study for this endpoint is available. Epidemiological data are availabe (see section 7.10.2) indicating that occupational exposure to hexavalent chromium compounds is linked to increased incidences of lung tumors. Supporting animal data are reported in this section. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dff16098-e94b-40a7-a602-75e3f0a80266/documents/58788c19-bcd5-4ad0-995b-d1d0789a7297_a8af0c5f-65d3-425a-aad7-7dfd66ae0da4.html,,,,,, Sodium dichromate,10588-01-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dff16098-e94b-40a7-a602-75e3f0a80266/documents/58788c19-bcd5-4ad0-995b-d1d0789a7297_a8af0c5f-65d3-425a-aad7-7dfd66ae0da4.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,5 mg/kg bw/day,,rat Sodium dichromate,10588-01-9," One key study for acute oral toxicity with sodium dichromate is available. No study is available for acute inhalation toxicity with sodium dichromate. However, based on the information available from acute inhalation toxicity with another chromium (VI) category substance (potassium dichromate), it was concluded using a category read-across concept that the formal data requirements are fulfilled. The approach for read-across is described in detail in the document attached in IUCLID section 13. One key study for acute dermal toxicity with sodium dichromate is available. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dff16098-e94b-40a7-a602-75e3f0a80266/documents/a4112b8a-c817-44e0-a6c6-25de60898e23_a8af0c5f-65d3-425a-aad7-7dfd66ae0da4.html,,,,,, Sodium dichromate,10588-01-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dff16098-e94b-40a7-a602-75e3f0a80266/documents/a4112b8a-c817-44e0-a6c6-25de60898e23_a8af0c5f-65d3-425a-aad7-7dfd66ae0da4.html,,oral,LD50,86.5 mg/kg bw,adverse effect observed, Sodium dichromate,10588-01-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dff16098-e94b-40a7-a602-75e3f0a80266/documents/a4112b8a-c817-44e0-a6c6-25de60898e23_a8af0c5f-65d3-425a-aad7-7dfd66ae0da4.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, Chromium trioxide,1333-82-0, High quality (NTP) studies using oral dosing are available for sodium dichromate and potassium dichromate in the rat and mouse. Repeated dose inhalation exposure studies are available for chromium trioxide. Longer term toxicity and carcinogenicity studies are also available for compounds in this group. ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57ddb222-ee75-4afe-a703-de543d802b79/documents/IUC5-d43e7f8a-9723-4358-aae7-51c1c58b49e4_b8e36b84-b99c-48cd-a63c-5bae91589793.html,,,,,, Chromium trioxide,1333-82-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57ddb222-ee75-4afe-a703-de543d802b79/documents/IUC5-d43e7f8a-9723-4358-aae7-51c1c58b49e4_b8e36b84-b99c-48cd-a63c-5bae91589793.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,1.7 mg/kg bw/day,,rat Chromium trioxide,1333-82-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57ddb222-ee75-4afe-a703-de543d802b79/documents/IUC5-d43e7f8a-9723-4358-aae7-51c1c58b49e4_b8e36b84-b99c-48cd-a63c-5bae91589793.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,1.81 mg/m3,,mouse Chromium trioxide,1333-82-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57ddb222-ee75-4afe-a703-de543d802b79/documents/IUC5-d43e7f8a-9723-4358-aae7-51c1c58b49e4_b8e36b84-b99c-48cd-a63c-5bae91589793.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1.81 mg/m3,adverse effect observed,mouse Chromium trioxide,1333-82-0," Proprietary (guideline & GLP-compliant) acute oral, dermal and inhalation studies are available for the compounds in this group. A number of additional published studies have been reviewed by the UK Health & Safety Executive (HSE, 1989), the UK Institute of Occupational Health (IOH, 1997) and the EU RAR (2005). The EU RAR also covers the studies previously reviewed in the other two reports. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57ddb222-ee75-4afe-a703-de543d802b79/documents/IUC5-1413e56c-c21b-4edd-8b4f-b550b2c0bf27_b8e36b84-b99c-48cd-a63c-5bae91589793.html,,,,,, Chromium trioxide,1333-82-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57ddb222-ee75-4afe-a703-de543d802b79/documents/IUC5-1413e56c-c21b-4edd-8b4f-b550b2c0bf27_b8e36b84-b99c-48cd-a63c-5bae91589793.html,,oral,LD50,52 mg/kg bw,adverse effect observed, Chromium trioxide,1333-82-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57ddb222-ee75-4afe-a703-de543d802b79/documents/IUC5-1413e56c-c21b-4edd-8b4f-b550b2c0bf27_b8e36b84-b99c-48cd-a63c-5bae91589793.html,,dermal,LD50,57 mg/kg bw,adverse effect observed, Chromium trioxide,1333-82-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57ddb222-ee75-4afe-a703-de543d802b79/documents/IUC5-1413e56c-c21b-4edd-8b4f-b550b2c0bf27_b8e36b84-b99c-48cd-a63c-5bae91589793.html,,inhalation,LC50,217 mg/m3,adverse effect observed, "Gasoline, pyrolysis, debutanizer bottoms",68606-10-0,"Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene / n-hexane - when present at 10%). Adequate information is available on the constituents to characterise the repeated dermal hazards of these streams. Adequate information is available on the constituents to characterise the repeated inhalation hazards of these streams. Adequate information is available on the constituents to characterise the repeated oral hazards of these streams. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c634c8b-adeb-4a2e-99a8-7b40f8143f61/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_6d75f4c9-6136-44c1-8b25-25af38c9d252.html,,,,,, "Gasoline, pyrolysis, debutanizer bottoms",68606-10-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c634c8b-adeb-4a2e-99a8-7b40f8143f61/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_6d75f4c9-6136-44c1-8b25-25af38c9d252.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Gasoline, pyrolysis, debutanizer bottoms",68606-10-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c634c8b-adeb-4a2e-99a8-7b40f8143f61/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_6d75f4c9-6136-44c1-8b25-25af38c9d252.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Gasoline, pyrolysis, debutanizer bottoms",68606-10-0,"Available data for one stream within this category (CAS 68516-20-1) and data on specific constituents (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Adequate information is available to characterise the short-term hazards of these streams. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c634c8b-adeb-4a2e-99a8-7b40f8143f61/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_6d75f4c9-6136-44c1-8b25-25af38c9d252.html,,,,,, "Gasoline, pyrolysis, debutanizer bottoms",68606-10-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c634c8b-adeb-4a2e-99a8-7b40f8143f61/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_6d75f4c9-6136-44c1-8b25-25af38c9d252.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Gasoline, pyrolysis, debutanizer bottoms",68606-10-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c634c8b-adeb-4a2e-99a8-7b40f8143f61/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_6d75f4c9-6136-44c1-8b25-25af38c9d252.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gasoline, pyrolysis, debutanizer bottoms",68606-10-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c634c8b-adeb-4a2e-99a8-7b40f8143f61/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_6d75f4c9-6136-44c1-8b25-25af38c9d252.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, "Naphtha (petroleum), light steam-cracked, thermally treated",98219-47-7,"Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene / n-hexane - when present at 10%). Adequate information is available on the constituents to characterise the repeated dermal hazards of these streams. Adequate information is available on the constituents to characterise the repeated inhalation hazards of these streams. Adequate information is available on the constituents to characterise the repeated oral hazards of these streams. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fefee54-5e1c-492e-8528-69991b32a0d4/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_84a0c9cd-714e-4d0d-8400-841cb2aaee66.html,,,,,, "Naphtha (petroleum), light steam-cracked, thermally treated",98219-47-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fefee54-5e1c-492e-8528-69991b32a0d4/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_84a0c9cd-714e-4d0d-8400-841cb2aaee66.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Naphtha (petroleum), light steam-cracked, thermally treated",98219-47-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fefee54-5e1c-492e-8528-69991b32a0d4/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_84a0c9cd-714e-4d0d-8400-841cb2aaee66.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Naphtha (petroleum), light steam-cracked, thermally treated",98219-47-7,"Available data for one stream within this category (CAS 68516-20-1) and data on specific constituents (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Adequate information is available to characterise the short-term hazards of these streams. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fefee54-5e1c-492e-8528-69991b32a0d4/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_84a0c9cd-714e-4d0d-8400-841cb2aaee66.html,,,,,, "Naphtha (petroleum), light steam-cracked, thermally treated",98219-47-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fefee54-5e1c-492e-8528-69991b32a0d4/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_84a0c9cd-714e-4d0d-8400-841cb2aaee66.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light steam-cracked, thermally treated",98219-47-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fefee54-5e1c-492e-8528-69991b32a0d4/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_84a0c9cd-714e-4d0d-8400-841cb2aaee66.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light steam-cracked, thermally treated",98219-47-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fefee54-5e1c-492e-8528-69991b32a0d4/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_84a0c9cd-714e-4d0d-8400-841cb2aaee66.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, "Naphtha (petroleum), full-range coker",68513-02-0,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/528d49d7-ce08-4a66-9c20-c7a86e3b92f6/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_598e626a-238f-42be-b1f3-3194161458b1.html,,,,,, "Naphtha (petroleum), full-range coker",68513-02-0,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/528d49d7-ce08-4a66-9c20-c7a86e3b92f6/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_598e626a-238f-42be-b1f3-3194161458b1.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), full-range coker",68513-02-0,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/528d49d7-ce08-4a66-9c20-c7a86e3b92f6/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_598e626a-238f-42be-b1f3-3194161458b1.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), full-range coker",68513-02-0,"The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401)Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions)Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/528d49d7-ce08-4a66-9c20-c7a86e3b92f6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_598e626a-238f-42be-b1f3-3194161458b1.html,,,,,, "Naphtha (petroleum), full-range coker",68513-02-0,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/528d49d7-ce08-4a66-9c20-c7a86e3b92f6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_598e626a-238f-42be-b1f3-3194161458b1.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), full-range coker",68513-02-0,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/528d49d7-ce08-4a66-9c20-c7a86e3b92f6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_598e626a-238f-42be-b1f3-3194161458b1.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), full-range coker",68513-02-0,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/528d49d7-ce08-4a66-9c20-c7a86e3b92f6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_598e626a-238f-42be-b1f3-3194161458b1.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, Iodomethane,74-88-4," Oral 90 Day dog study:Under the conditions of this study the NOAEL was considered to be 1.5 mg/kg/day for male and female dogs. 90 day rat: Under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) of the test material was 5 mg/kg/day in males, and the No Observed Effect Level (NOEL) of the test material was 5 mg/kg/day in females. 90 day mouse dietary study: The no-observed-effect level (NOEL) for oral (diet) administration of the test material to mice for at least 90 days was less than 133 ppm. The no-observed-adverse-effect level (NOAEL) was 400 ppm. 1 year dog: The no-observed-adverse-effect level (NOAEL) for oral (capsule) administration of the test material to dogs for 52 consecutive weeks was 1.5 mg/kg/day. Inhalation Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for whole-body inhalation exposure to the test material in rats for four or 13 weeks was 20 ppm. (mg/m3 from ppm = ppm x mwt(141.935)/24.45 = 116 mg/m3) Dermal Under the conditions of this study, the no-observed-adverse-effect level (NOAEL) for systemic toxicity of the test material when administered dermally to rats for 21 consecutive days was 30 mg/kg/day. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/405c3174-8c9d-46ec-9ddd-dc13340c3835/documents/IUC5-30e0a27c-eafe-4448-8bbb-312f973a25b1_e3478c0a-7b7a-4b17-bdb2-77d7f9048c22.html,,,,,, Iodomethane,74-88-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/405c3174-8c9d-46ec-9ddd-dc13340c3835/documents/IUC5-30e0a27c-eafe-4448-8bbb-312f973a25b1_e3478c0a-7b7a-4b17-bdb2-77d7f9048c22.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,30 mg/kg bw/day,,rat Iodomethane,74-88-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/405c3174-8c9d-46ec-9ddd-dc13340c3835/documents/IUC5-30e0a27c-eafe-4448-8bbb-312f973a25b1_e3478c0a-7b7a-4b17-bdb2-77d7f9048c22.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,116 mg/m3,,rat Iodomethane,74-88-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/405c3174-8c9d-46ec-9ddd-dc13340c3835/documents/IUC5-30e0a27c-eafe-4448-8bbb-312f973a25b1_e3478c0a-7b7a-4b17-bdb2-77d7f9048c22.html,Chronic toxicity – systemic effects,oral,NOAEL,1.5 mg/kg bw/day,,dog Iodomethane,74-88-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/405c3174-8c9d-46ec-9ddd-dc13340c3835/documents/IUC5-30e0a27c-eafe-4448-8bbb-312f973a25b1_e3478c0a-7b7a-4b17-bdb2-77d7f9048c22.html,Repeated dose toxicity – local effects,inhalation,NOAEC,116 mg/m3,adverse effect observed,rat Iodomethane,74-88-4," Acute Oral Rat Under the conditions of this study, the acute oral LD50 was determined to be 79.84 mg/kg and 131.98 mg/kg in male and female rats respectively.  Acute Oral Mouse Under the conditions of this test, the acute oral LD50 of the test material in the male mouse was determined to be 155 mg/kg. In the female mouse, the oral LD50 was determined to be 214 mg/kg. In the sexes combined, the oral LD50 was determined to be 179 mg/kg . Acute Inhalation Under the conditions of this study, the acute inhalation LC50 was 691 ppm in both male and female rats. Acute Dermal Under the conditions of this study the percutaneous LD50 was found to be in excess of 2000 mg/kg for both male and female rabbits. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/405c3174-8c9d-46ec-9ddd-dc13340c3835/documents/IUC5-66b07c87-d255-45d9-a0fb-d934a5dcbe02_e3478c0a-7b7a-4b17-bdb2-77d7f9048c22.html,,,,,, Iodomethane,74-88-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/405c3174-8c9d-46ec-9ddd-dc13340c3835/documents/IUC5-66b07c87-d255-45d9-a0fb-d934a5dcbe02_e3478c0a-7b7a-4b17-bdb2-77d7f9048c22.html,,oral,LD50,79.84 mg/kg bw,adverse effect observed, Iodomethane,74-88-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/405c3174-8c9d-46ec-9ddd-dc13340c3835/documents/IUC5-66b07c87-d255-45d9-a0fb-d934a5dcbe02_e3478c0a-7b7a-4b17-bdb2-77d7f9048c22.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Iodomethane,74-88-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/405c3174-8c9d-46ec-9ddd-dc13340c3835/documents/IUC5-66b07c87-d255-45d9-a0fb-d934a5dcbe02_e3478c0a-7b7a-4b17-bdb2-77d7f9048c22.html,,inhalation,LC50,"4,011 mg/m3",adverse effect observed, Ephedrine,299-42-3,"In an acute oral toxicity study (similar to OECD 401), the LD50 was determined to be ca. 681 mg/kg bw. In an acute inhalation toxicity study (similar to OECD 403), the LC50 was determined to be >5.4 mg/L. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f802eff3-10bd-433d-9680-5ebcf2b34902/documents/IUC5-168cc8ab-2842-4723-b75b-064629b4a8f0_44c25f65-59ba-47af-92d1-2eba3d69eca5.html,,,,,, Ephedrine,299-42-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f802eff3-10bd-433d-9680-5ebcf2b34902/documents/IUC5-168cc8ab-2842-4723-b75b-064629b4a8f0_44c25f65-59ba-47af-92d1-2eba3d69eca5.html,,oral,LD50,681 mg/kg bw,adverse effect observed, "2,3-epoxypropyl phenyl ether",122-60-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ff54da2-72bf-4d13-aa3f-017b736eb318/documents/IUC5-3cd3b459-cbd0-4a51-b35f-407069c1f4c2_f9d6f5e1-4dd4-4c2e-acf1-142225054718.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,72.47 mg/m3,,rat "2,3-epoxypropyl phenyl ether",122-60-1,"In accordance with the harmonised scheme for classification and labelling in Regulation EC 1272/2008, phenylglycidyl ether (index number 603 -067 -00 -X) is classified as Acute Toxicity Oral Category 4 and Acute Toxicity Inhalation Category 4. The data available to the registrant for acute oral toxicity classification does not trigger the classification Acute Toxicity Oral Category 4 as indicated in the harmonised classification and labelling scheme. Nor do the data available to the registrant on acute inhalation toxicity does not trigger the classification Acute Inhalation Toxicity Category 4 as indicated in the harmonised classification scheme. Regardless of these inconsistencies, the classifications listed in the harmonised scheme for phenylglycidyl ether will be implemented by the registrant.The registrant is not in possession of adequate data available for acute dermal toxicity of phenylglycidyl ether. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ff54da2-72bf-4d13-aa3f-017b736eb318/documents/IUC5-c299ddf2-437d-4194-8355-920a57182303_f9d6f5e1-4dd4-4c2e-acf1-142225054718.html,,,,,, "2,3-epoxypropyl phenyl ether",122-60-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ff54da2-72bf-4d13-aa3f-017b736eb318/documents/IUC5-c299ddf2-437d-4194-8355-920a57182303_f9d6f5e1-4dd4-4c2e-acf1-142225054718.html,,oral,LD50,"2,600 mg/kg bw",, "2,3-epoxypropyl phenyl ether",122-60-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ff54da2-72bf-4d13-aa3f-017b736eb318/documents/IUC5-c299ddf2-437d-4194-8355-920a57182303_f9d6f5e1-4dd4-4c2e-acf1-142225054718.html,,inhalation,LC50,"1,984 mg/m3",, "Gas oils (petroleum), hydrodesulfurized",64742-79-6," There are three sub-acute repeated dose oral studies conducted according to OECD TG 422 and one 90 -day oral toxicity study according to OECD TG 408. In a 90-day oral study on CAS 64742-79-6, there were no treatment related adverse effects on systemic toxicity up to and including the highest dose of 1000 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 1000 mg/kg/day corresponding achieved dose level of 970 mg/kg/day for males and 971 mg/kg/day for females (under the test conditions and doses employed). In sub-acute oral studies on CAS 64742-79-6 and CAS 64742-46-7, there were no treatment-related adverse effects on systemic toxicity parameters up to and including the highest doses tested (1000 and 750 mg/kg/day respectively) and accordingly the NOAELs were set at these levels. In a sub-acute oral study on CAS 64742-80-9 (conducted according to OECD TG 422) at doses of 100, 300 and 1000 mg/kg/day. At 300 mg/kg/day, there were minimal gross pathological, histopathological, or biochemical treatment-related effects such as higher liver weights, spleen weights, hypertrophy in liver, follicular epithelial hypertrophy in thyroid and hyaline droplets in kidneys. This dose was determined to be the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats. A second OECD 422 study on CAS 64742-80-9 has recently reported and is included as an endpoint study record; results and potential follow-up actions (further testing proposals and/or classification) are currently under discussion and are not yet included in this summary section. In two 28-day inhalation studies with hydrodesulphurised middle distillates(CAS 64742-80-9), the Lowest Observed Adverse Effect Level (LOAEL) values were 23 and 24 mg/m3(equivalent to OECD TG 412).  These studies and values were considered unreliable.     A 90-day inhalation study of diesel fuel (aerosol) (a read-across study from VHGO category; substance CAS 68334-30-5) resulted in a conservative sub-chronic No Observed Adverse Effect Concentration (NOAEC) of 0.88 mg/L determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of greater than or equal to 1.71 mg/L was established for systemic effects, based on no significant findings at this level (OECD TG 413).   The systemic NOAEL for 28-day dermal exposure to other gas oils was 1000 mg/kg/day, based on moribund state and early mortality in the higher dose groups (OECD TG 410).   In a read-across study (from the CrackedGO category; substance CAS 64741-59-9), a systemic NOAEL of 25 mg/kg body weight/day was obtained for males, and 125 mg/kg body weight/day for females, based upon reductions in thymus weight (OECD TG 411).  In another 90-day sub-chronic study (OECD TG 411),  dermal exposure to coker light gas oil resulted in a systemic LOAEL of 30 mg/kg body weight/day for males and females, based upon clinical signs and irritation noted at all doses. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d34401c6-cd3f-4582-9135-a81757dc8529/documents/4153b25a-c693-4dd2-840b-48bff6f387a4_7dac1552-d0c2-4757-85ea-65c032ec3ae8.html,,,,,, "Gas oils (petroleum), hydrodesulfurized",64742-79-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d34401c6-cd3f-4582-9135-a81757dc8529/documents/4153b25a-c693-4dd2-840b-48bff6f387a4_7dac1552-d0c2-4757-85ea-65c032ec3ae8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Gas oils (petroleum), hydrodesulfurized",64742-79-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d34401c6-cd3f-4582-9135-a81757dc8529/documents/4153b25a-c693-4dd2-840b-48bff6f387a4_7dac1552-d0c2-4757-85ea-65c032ec3ae8.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,25 mg/kg bw/day,,rat "Gas oils (petroleum), hydrodesulfurized",64742-79-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d34401c6-cd3f-4582-9135-a81757dc8529/documents/4153b25a-c693-4dd2-840b-48bff6f387a4_7dac1552-d0c2-4757-85ea-65c032ec3ae8.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Gas oils (petroleum), hydrodesulfurized",64742-79-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d34401c6-cd3f-4582-9135-a81757dc8529/documents/4153b25a-c693-4dd2-840b-48bff6f387a4_7dac1552-d0c2-4757-85ea-65c032ec3ae8.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Gas oils (petroleum), hydrodesulfurized",64742-79-6,"Acute Oral Toxicity:The acute oral LD50 for other gas oils is > 5000 mg/kg of bodyweight in male and female rats, based on no mortality and minimal signs of toxicity (OECD 401).Acute Inhalation Toxicity:The acute inhalation LC50 for other gas oils for both male and female rats is 4.6 mg/L (aerosol) (OECD 403). This is supported by a further study  in which a hydrodesulphurised middle distillate gave an LC50 of 7.64 mg/L (aerosol). In addition a read-across study with a straight run gas oil gave an LC50 of >2.53 mg/lAcute Dermal Toxicity:The acute dermal LD50 for other gas oils is > 2000mg/kg body weight for male and female rabbits, based on no mortality or evidence of adverse effects (OECD 402). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d34401c6-cd3f-4582-9135-a81757dc8529/documents/c88d6084-86a3-40df-b097-077ae945a66f_7dac1552-d0c2-4757-85ea-65c032ec3ae8.html,,,,,, "Gas oils (petroleum), hydrodesulfurized",64742-79-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d34401c6-cd3f-4582-9135-a81757dc8529/documents/c88d6084-86a3-40df-b097-077ae945a66f_7dac1552-d0c2-4757-85ea-65c032ec3ae8.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), hydrodesulfurized",64742-79-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d34401c6-cd3f-4582-9135-a81757dc8529/documents/c88d6084-86a3-40df-b097-077ae945a66f_7dac1552-d0c2-4757-85ea-65c032ec3ae8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), hydrodesulfurized",64742-79-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d34401c6-cd3f-4582-9135-a81757dc8529/documents/c88d6084-86a3-40df-b097-077ae945a66f_7dac1552-d0c2-4757-85ea-65c032ec3ae8.html,,inhalation,LC50,"4,600 mg/m3",no adverse effect observed, Nickel sulphate,7786-81-4," Value used for CSA: NOAEL (oral, systemic, animal): 10 mg Ni sulphate hexahydrate /kg bw/day (or 2.2 mg Ni/kg bw/day) (Heim et al. 2007) NOAEC (inhalation, local, animal): 0.12 mg Ni sulphate hexahydrate /m³ air ( or 0.027 mg Ni/m3air) (Dunnick et al., 1995) LOAEC(inhalation, local, animal): 0.25 mg nickel sulphate hexahydrate/m3(or 0.056 mg Ni/m3)(Dunnick et al., 1995) Target organs: respiratory: lung ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20b966fb-709c-4185-9f58-c49f34cc071f/documents/f811b3a2-e476-4084-961e-6c133c62b7c0_91b580b4-67d2-46ce-8e57-197f74e8d1a2.html,,,,,, Nickel sulphate,7786-81-4," Value used for CSA: NOAEL (oral, systemic, animal): 100 mg NiSO4.6H2O/kg bw(22 mg Ni/kg bw/day) (FDRL, 1983) LOAEL (oral, systemic, human data): 0.012 mg Ni (Ni ion)/kg bw/day released from metallic nickel in water and food contact material (Nielsen et al 1999) NOAEC (inhalation, systemic, animal): 0.53 mg NiSO4.6H2O/L air (120 mg Ni/m3) (EPSL, 2009b) LOAEC (inhalation, local, animal data): 0.7 mg Ni/m3 (DNEL calculation is based on 16-day repeated dose study-Benson et al, 1988; no adequate acute data was available) An acute local inhalation DNEL is derived based on the lung effects (e.g. lung inflammation) associated with nickel sulphate inhalation.  The shortest-term study available examining those effects in animals is a 16-day repeated exposure study.  An adjustment factor was derived to extrapolate the results from the repeated exposure study to an equivalent effect concentration in a 4 hr acute exposure.  See Appendix C3 for more information. (Oral, local values are not applicable; Dermal, local or systemic, values are not applicable) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20b966fb-709c-4185-9f58-c49f34cc071f/documents/9dcbf6c5-bf28-43eb-bfab-f6a9053d3d0e_91b580b4-67d2-46ce-8e57-197f74e8d1a2.html,,,,,, "3,5,5-trimethylcyclohex-2-enone",78-59-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5aa8895-635c-4cba-b307-2dfa16355616/documents/IUC5-bd828bfd-fa51-47a8-9961-3fa4e6aaa957_be90273e-0ed3-4832-833c-5e1bcb01c7c6.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,250 mg/m3,,rat "3,5,5-trimethylcyclohex-2-enone",78-59-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5aa8895-635c-4cba-b307-2dfa16355616/documents/IUC5-bd828bfd-fa51-47a8-9961-3fa4e6aaa957_be90273e-0ed3-4832-833c-5e1bcb01c7c6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,102.5 mg/kg bw/day,,rat "3,5,5-trimethylcyclohex-2-enone",78-59-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5aa8895-635c-4cba-b307-2dfa16355616/documents/IUC5-bd828bfd-fa51-47a8-9961-3fa4e6aaa957_be90273e-0ed3-4832-833c-5e1bcb01c7c6.html,Repeated dose toxicity – local effects,inhalation,LOAEC,250 mg/m3,adverse effect observed,rat "3,5,5-trimethylcyclohex-2-enone",78-59-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5aa8895-635c-4cba-b307-2dfa16355616/documents/IUC5-12514f07-1857-4c5c-a8f5-8b260510a8b4_be90273e-0ed3-4832-833c-5e1bcb01c7c6.html,,oral,LD50,"1,500 mg/kg bw",adverse effect observed, "3,5,5-trimethylcyclohex-2-enone",78-59-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5aa8895-635c-4cba-b307-2dfa16355616/documents/IUC5-12514f07-1857-4c5c-a8f5-8b260510a8b4_be90273e-0ed3-4832-833c-5e1bcb01c7c6.html,,dermal,LD50,"1,200 mg/kg bw",adverse effect observed, "3,5,5-trimethylcyclohex-2-enone",78-59-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5aa8895-635c-4cba-b307-2dfa16355616/documents/IUC5-12514f07-1857-4c5c-a8f5-8b260510a8b4_be90273e-0ed3-4832-833c-5e1bcb01c7c6.html,,inhalation,LC50,"7,000 mg/m3",adverse effect observed, Nitrobenzene,98-95-3,Rat Oral LD50 study (10 rats per sex per group) ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e96f7e53-5b1e-4bf2-bb1d-9632f4d4ccca/documents/IUC5-b29f41ce-0772-4f59-bf07-cf861aeac9f4_30a52c40-2d05-4430-a30f-65e6b38359ac.html,,,,,, Nitrobenzene,98-95-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e96f7e53-5b1e-4bf2-bb1d-9632f4d4ccca/documents/IUC5-b29f41ce-0772-4f59-bf07-cf861aeac9f4_30a52c40-2d05-4430-a30f-65e6b38359ac.html,,oral,LD50,588 mg/kg bw,, "Gases (petroleum), light steam-cracked, butadiene conc.",68955-28-2," Members of the C4 high 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. Data after inhalational exposure are available on one of the streams in this category (All CAS numbers are; 68476-52-8, 68477-42-9, 68955-28-2, 87741-01-3, 92045-23-3) and on the constituent substances (1,3-butadiene, butane, isobutane and butene isomers) and indicate that the sub-chronic toxicity of this category is low. Inhalation exposure is the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in rats or mice in inhalation studies ranging from 7 weeks to 2 years on CAS no. 68476-52-82, butane, isobutane and 2-methylpropene. Nasal lesions were observed in 2 year studies on 2-methylpropene at the highest concentration in male rats. 1,3-Butadiene had low repeat dose toxicity in humans and rats (the most appropriate test species). The mouse was the most sensitive species where the target organs are bone marrow, ovary and testis. Species differences in metabolism are believed to be responsible for the species specific toxicity with humans being more similar to rats The NOAEL of 1000 ppm (2212 mg/m3) was identified from the key study on 1,3-butadiene in rats. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1d553a04-dc80-4d72-905c-f74668cb972c/documents/IUC5-106b9c59-8ac8-4eb0-8b6a-307fee43b208_efa30ce3-f8ff-4e3d-945c-9d9565bb754f.html,,,,,, "Gases (petroleum), light steam-cracked, butadiene conc.",68955-28-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1d553a04-dc80-4d72-905c-f74668cb972c/documents/IUC5-106b9c59-8ac8-4eb0-8b6a-307fee43b208_efa30ce3-f8ff-4e3d-945c-9d9565bb754f.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"2,212 mg/m3",, "Gases (petroleum), light steam-cracked, butadiene conc.",68955-28-2,"Members of the C4 high 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. Data are available on some members of the streams in this category (All CAS numbers are; 68476-52-8, 68477-42-9, 68955-28-2, 87741-01-3, 92045-23-3) and on the constituent substances (1,3-butadiene, butane, isobutane and butene isomers) and indicate that the acute inhalational toxicity of this category is low. The LC50 values are in excess of 10,000 ppm (22,948 mg/m3), limited data suggests that 1,3-butadiene is not acutely toxic in humans and butane and isobutane are considered to be Generally Recognised as Safe and may be used in food products. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d553a04-dc80-4d72-905c-f74668cb972c/documents/IUC5-de665b61-fce1-4b81-8865-57fe756193bf_efa30ce3-f8ff-4e3d-945c-9d9565bb754f.html,,,,,, Trifluoroiodomethane,2314-97-8, Two sub-chronic and several sub-acute toxicity are available. Based on the key study a NOAEC of 20000 ppm (or 160254 mg/m3) is derived. ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a8a3f67-8646-43d0-b8fd-53a850490751/documents/cdae1387-a691-406d-a075-ede31297f039_7adffacd-7435-4047-97c1-37e92db95973.html,,,,,, Trifluoroiodomethane,2314-97-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a8a3f67-8646-43d0-b8fd-53a850490751/documents/cdae1387-a691-406d-a075-ede31297f039_7adffacd-7435-4047-97c1-37e92db95973.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"160,254 mg/m3",,rat Trifluoroiodomethane,2314-97-8," Two acute toxicity studies via inhalation are available. Based on the key study, a discriminating concentration of 20969 ppm is derived. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a8a3f67-8646-43d0-b8fd-53a850490751/documents/02325e1d-c239-4ac7-9c12-4046c15615f3_7adffacd-7435-4047-97c1-37e92db95973.html,,,,,, Trifluoroiodomethane,2314-97-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a8a3f67-8646-43d0-b8fd-53a850490751/documents/02325e1d-c239-4ac7-9c12-4046c15615f3_7adffacd-7435-4047-97c1-37e92db95973.html,,inhalation,discriminating conc.,"168,018 mg/m3",no adverse effect observed, Hyoscine,51-34-3, The most sensitive subchronic value of 45 mg/kg bw (five days a week) was determined in a NTP (National Toxicology Program) study conducted with rats in the 14 -weeks study (oral gavage). The exposure for five days per week under test conditions was extrapolated to seven days per week resulting in the NOAEL value of 32.14 mg/kg bw/day. ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/240a0a1d-0ce3-4c15-8826-1fe881fda1e4/documents/IUC5-a66c38f5-1edc-4578-a63b-d0bfd8d7f40d_f7c27a11-3f8d-4c4f-9ece-b1d34db7b0c9.html,,,,,, Hyoscine,51-34-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/240a0a1d-0ce3-4c15-8826-1fe881fda1e4/documents/IUC5-a66c38f5-1edc-4578-a63b-d0bfd8d7f40d_f7c27a11-3f8d-4c4f-9ece-b1d34db7b0c9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,32.14 mg/kg bw/day,,rat Hyoscine,51-34-3," According to CLP Regulation Annex VI scopolamine is harmonised classified as acute oral toxic category 2 (H300), acute dermal toxic category 1 (H310) and acute inhalation toxic category 2 (H330). Based on the available data no further investigations are necessary. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/240a0a1d-0ce3-4c15-8826-1fe881fda1e4/documents/IUC5-38f7b785-cf2f-40bb-82e8-0f6ee24e0ac8_f7c27a11-3f8d-4c4f-9ece-b1d34db7b0c9.html,,,,,, "Distillates (petroleum), light paraffinic",64741-50-0,"In a read-across 90-day oral study (equivalent to OECD 408) from distillate aromatic extract, a NOAEL could not be identified and is less than 125 mg/kg/day to male rats.  In a read-across subacute inhalation study (non-guideline) from other lubricant base oils (IP 346 < 3%), the NOAEC for pulmonary effects was 500 mg/m3, and the NOAEC for systemic effects resulting from inhalation exposure was ≥1500 mg/m3 in rats. One key 28-day dermal study (OECD 410) was identified, along with one read-across 90-day dermal study (OECD 411) from distillate aromatic extract. For the 28-day dermal study, the systemic NOAEL in this study is 1000 mg/kg/day for rabbits dosed with 0, 200, 1000, or 2000 mg/kg/day. The dermal NOAEL is <200 mg/kg/day based on the irritation at the treatment site.  For the 90-day dermal read-across study conducted with rats at dose levels of 30, 125, 500, or 1250 mg/kg/day, the LOAEL is 30 mg/kg/day, based on body weight, clinical chemistry, organ weights, gross pathology, and histopathology. A NOAEL is not identified. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c94df2f-ecb3-4709-ad71-eb82304cde62/documents/5af7fd89-2b85-4d09-95c9-bff5096e2551_c0b89af6-a026-4b95-b353-bfb4daa76d11.html,,,,,, "Distillates (petroleum), light paraffinic",64741-50-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c94df2f-ecb3-4709-ad71-eb82304cde62/documents/5af7fd89-2b85-4d09-95c9-bff5096e2551_c0b89af6-a026-4b95-b353-bfb4daa76d11.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,500 mg/m3",,rat "Distillates (petroleum), light paraffinic",64741-50-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c94df2f-ecb3-4709-ad71-eb82304cde62/documents/5af7fd89-2b85-4d09-95c9-bff5096e2551_c0b89af6-a026-4b95-b353-bfb4daa76d11.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Distillates (petroleum), light paraffinic",64741-50-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c94df2f-ecb3-4709-ad71-eb82304cde62/documents/5af7fd89-2b85-4d09-95c9-bff5096e2551_c0b89af6-a026-4b95-b353-bfb4daa76d11.html,Sub-chronic toxicity – systemic effects,dermal,LOAEL,30 mg/kg bw/day,,rat "Distillates (petroleum), light paraffinic",64741-50-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c94df2f-ecb3-4709-ad71-eb82304cde62/documents/5af7fd89-2b85-4d09-95c9-bff5096e2551_c0b89af6-a026-4b95-b353-bfb4daa76d11.html,Repeated dose toxicity – local effects,dermal,LOAEL,12.5 mg/cm2,adverse effect observed,rabbit "Distillates (petroleum), light paraffinic",64741-50-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c94df2f-ecb3-4709-ad71-eb82304cde62/documents/5af7fd89-2b85-4d09-95c9-bff5096e2551_c0b89af6-a026-4b95-b353-bfb4daa76d11.html,Repeated dose toxicity – local effects,inhalation,NOAEC,500 mg/m3,adverse effect observed,rat "Distillates (petroleum), light paraffinic",64741-50-0,Key acute oral (OECD 401) and dermal (OECD 402) studies were identified for unrefined acid treated oils.  A read-across acute toxicity for inhalation (OECD 403) was identified from distillate aromatic extracts.  LD50 and LC50 values were as follows:• The oral LD50 was > 5000 mg/kg bw in male and female rats exposed to unrefined/acid treated oil.• The dermal LD50 was > 2000 mg/kg bw in male and female rabbits exposed to unrefined/acid treated oil.• The LC50 was >5 mg/L (equivalent to 5000 mg/m3) in male and female rats exposed to distillate aromatic extract. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c94df2f-ecb3-4709-ad71-eb82304cde62/documents/52eeeb26-c313-4153-a707-482add55ac03_c0b89af6-a026-4b95-b353-bfb4daa76d11.html,,,,,, "Distillates (petroleum), light paraffinic",64741-50-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c94df2f-ecb3-4709-ad71-eb82304cde62/documents/52eeeb26-c313-4153-a707-482add55ac03_c0b89af6-a026-4b95-b353-bfb4daa76d11.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light paraffinic",64741-50-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c94df2f-ecb3-4709-ad71-eb82304cde62/documents/52eeeb26-c313-4153-a707-482add55ac03_c0b89af6-a026-4b95-b353-bfb4daa76d11.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light paraffinic",64741-50-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c94df2f-ecb3-4709-ad71-eb82304cde62/documents/52eeeb26-c313-4153-a707-482add55ac03_c0b89af6-a026-4b95-b353-bfb4daa76d11.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Diethyl maleate,141-05-9,"Acute toxicity, oral, rats: LD50 > 3200 mg/kg bw.Acute toxicity, dermal, rats: LD50 > 2500 mg/kg bw.Acute toxicity, inhalation, rats: saturated vapours of the test material were survived for 8 hours. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb44e2c7-7ef7-49cc-a519-190d1e200f4e/documents/IUC5-e339103b-32b2-472e-92eb-89fb928a8ff8_3fbc657e-c296-4378-95e0-2283eaf69546.html,,,,,, Diethyl maleate,141-05-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb44e2c7-7ef7-49cc-a519-190d1e200f4e/documents/IUC5-e339103b-32b2-472e-92eb-89fb928a8ff8_3fbc657e-c296-4378-95e0-2283eaf69546.html,,oral,LD50,"3,200 mg/kg bw",, Diethyl maleate,141-05-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb44e2c7-7ef7-49cc-a519-190d1e200f4e/documents/IUC5-e339103b-32b2-472e-92eb-89fb928a8ff8_3fbc657e-c296-4378-95e0-2283eaf69546.html,,dermal,LD50,"2,500 mg/kg bw",, Diethyl maleate,141-05-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb44e2c7-7ef7-49cc-a519-190d1e200f4e/documents/IUC5-e339103b-32b2-472e-92eb-89fb928a8ff8_3fbc657e-c296-4378-95e0-2283eaf69546.html,,inhalation,LC50,"16,000 mg/m3",, Dinoseb,88-85-7,"Irvine, 1981, was selected as the key information for this end point. The study was conducted in a similar manner to the OECD 408 guideline. The study was only allocated a reliability score of 2 according to the criteria of Klimisch et al, 1997, because of deviations which affect the reliability of the study result, however in view of the findings of the study and the methodology used the study was considered to be of adequate reliability to fulfil the regulatory requirement.The study was performed as part of a 3 generation reproduction/developmental toxicity study and was performed as a feeding study on the rat for a period of 13 weeks prior to two mating periods of 8 weeks each for a total dosing period of 29 weeks. Concentrations in feed were set to give three test groups of 1, 3 and 10mg/kg bw/day with 50 animals (25 male/25 female) in each test group.Based upon the observations reported for parental animals (F0 generation) the NOAEL for repeat dose toxicity was set at 3mg/kg bw/day. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/285eb21d-cd96-4739-9fdc-c1ac34fb6072/documents/IUC5-067320d0-f24b-4d85-873a-2bb19ae5300a_db79c85d-947a-4726-8af2-d88a42762252.html,,,,,, Dinoseb,88-85-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/285eb21d-cd96-4739-9fdc-c1ac34fb6072/documents/IUC5-067320d0-f24b-4d85-873a-2bb19ae5300a_db79c85d-947a-4726-8af2-d88a42762252.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,3 mg/kg bw/day,,rat Dinoseb,88-85-7,"Acute toxicity: oralThe key study (Kynoch, 1984) was conducted according to the OECD 401 guideline and was given a reliability score of 2 according to the criteria of Klimisch et al, 1997, based upon the level of reporting. The study reported an LD50 value of 24mg/kg bw for the registered substance.Acute toxicity: dermalThe key study (Kynoch, 1984) was conducted according to the OECD 402 guideline and was given a reliability score of 2 according to the criteria of Klimisch et al, 1997, based upon the level of reporting. The study reported an LD50 value of 217.5mg/kg bw for the registered substance. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/285eb21d-cd96-4739-9fdc-c1ac34fb6072/documents/IUC5-350bc9bf-5e9c-4f55-b04f-430bd3a74c37_db79c85d-947a-4726-8af2-d88a42762252.html,,,,,, Dinoseb,88-85-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/285eb21d-cd96-4739-9fdc-c1ac34fb6072/documents/IUC5-350bc9bf-5e9c-4f55-b04f-430bd3a74c37_db79c85d-947a-4726-8af2-d88a42762252.html,,oral,LD50,24 mg/kg bw,, Dinoseb,88-85-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/285eb21d-cd96-4739-9fdc-c1ac34fb6072/documents/IUC5-350bc9bf-5e9c-4f55-b04f-430bd3a74c37_db79c85d-947a-4726-8af2-d88a42762252.html,,dermal,LD50,217.5 mg/kg bw,, Tellurium,13494-80-9, The main effect observed upon oral exposure in the different sub-acute and sub-chronic available studies is reduction of weight and weight gain. At microscopic examination also changes in the liver were noted. However the severeness of the effects vary within the different studies and affected animals recover upon cessation of the treatment. ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/717c1745-c03b-4962-95b3-e3a4153a1bc1/documents/8e31f003-d18a-40e2-8759-12a3c141b899_ae402d4f-ec7a-4236-bbbc-b16f88518d0f.html,,,,,, Tellurium,13494-80-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/717c1745-c03b-4962-95b3-e3a4153a1bc1/documents/8e31f003-d18a-40e2-8759-12a3c141b899_ae402d4f-ec7a-4236-bbbc-b16f88518d0f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Tellurium,13494-80-9,"Acute oral toxicity: LD50 > 5000 mg/kg bw, OECD Guideline 401, GLP compliantAcute inhalation toxicity: LC50 > 2.42 mg/L, according to OECD Guideline 403, GLP compliantAcute dermal toxicity: no data available Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The key studies are GLP-compliant and of high quality (Klimisch 1). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The key study is GLP-compliant and of high quality (Klimisch 1). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/717c1745-c03b-4962-95b3-e3a4153a1bc1/documents/5504bc58-80c8-475c-8cfa-11757224fcca_ae402d4f-ec7a-4236-bbbc-b16f88518d0f.html,,,,,, Tellurium,13494-80-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/717c1745-c03b-4962-95b3-e3a4153a1bc1/documents/5504bc58-80c8-475c-8cfa-11757224fcca_ae402d4f-ec7a-4236-bbbc-b16f88518d0f.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Tellurium,13494-80-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/717c1745-c03b-4962-95b3-e3a4153a1bc1/documents/5504bc58-80c8-475c-8cfa-11757224fcca_ae402d4f-ec7a-4236-bbbc-b16f88518d0f.html,,inhalation,LC50,"2,420 mg/m3",adverse effect observed, Divanadium pentaoxide,1314-62-1,"According to EC Regulation 1272-2008 Table 3.1 ""List of harmonised classification and labelling of hazardous substances"", V2O5 is legally classified as STOT RE 1 H372 (respiratory tract, inhalation) ""Cause damage to organs through prolonged or repeated exposure"".   ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a9275b7-3267-4763-aee1-12db6c8b99e7/documents/5bef145c-df65-48ae-80e8-aef8f84a94df_c1802706-778c-42fc-8555-5205094a061d.html,,,,,, Divanadium pentaoxide,1314-62-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a9275b7-3267-4763-aee1-12db6c8b99e7/documents/5bef145c-df65-48ae-80e8-aef8f84a94df_c1802706-778c-42fc-8555-5205094a061d.html,Repeated dose toxicity – local effects,inhalation,LOAEC,0.5 mg/m3,adverse effect observed,rat Divanadium pentaoxide,1314-62-1,"Acute toxicity: According to EC Regulation 1272-2008 Table 3.1 ""List of harmonised classification and labelling of hazardous substances"", V2O5 is legally classified as Acute Tox. 3 H301 ""Toxic if swallowed"" and Acute Tox. 2 H330 ""Fatal if inhaled"". No acute toxicity was observed after dermal administration of up to 2500 mg V2O5 /kg b.w. in rats in three different grades (i.e. analytical-pulverised). According to EC Regulation 1272 /2008, V2O5 can be classified as relatively non-toxic based on results in acute dermal toxicity studies in the rat. Respiratory irritation: According to EC Regulation 1272-2008 Table 3.1 ""List of harmonised classification and labelling of hazardous substances"", V2O5 is legally classified as STOT SE Category 3: H335: May cause respiratory irritation. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a9275b7-3267-4763-aee1-12db6c8b99e7/documents/IUC5-5d3cfe8f-d907-4316-8079-46aabd62fa8e_c1802706-778c-42fc-8555-5205094a061d.html,,,,,, Divanadium pentaoxide,1314-62-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a9275b7-3267-4763-aee1-12db6c8b99e7/documents/IUC5-5d3cfe8f-d907-4316-8079-46aabd62fa8e_c1802706-778c-42fc-8555-5205094a061d.html,,oral,LD50,221 mg/kg bw,adverse effect observed, Divanadium pentaoxide,1314-62-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a9275b7-3267-4763-aee1-12db6c8b99e7/documents/IUC5-5d3cfe8f-d907-4316-8079-46aabd62fa8e_c1802706-778c-42fc-8555-5205094a061d.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, Divanadium pentaoxide,1314-62-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a9275b7-3267-4763-aee1-12db6c8b99e7/documents/IUC5-5d3cfe8f-d907-4316-8079-46aabd62fa8e_c1802706-778c-42fc-8555-5205094a061d.html,,inhalation,LC50,"2,210 mg/m3",adverse effect observed, "Distillates (petroleum), hydrodesulfurized light catalytic cracked",68333-25-5,"No repeat dose toxicity studies have been identified for cracked gas oils, following inhalation or oral exposure. The sub-chronic inhalation study of diesel fuel (OECD 413, a read-across study from VGO/HGO/Distillate Fuels) resulted in a conservative sub-chronic NOAEC of 0.88 mg/L determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of ≥1.71 mg/L was established for systemic effects, based on no significant findings at this level.In a 28-day sub-acute study (OECD 410), dermal exposure to a light catalytically cracked distillate resulted in limited systemic changes and a NOAEL of 500 mg/kg body weight/day.  In a 90-day sub-chronic study (OECD 411), dermal exposure to light catalytically cracked distillate resulted in a systemic NOAEL of 25 mg/kg body weight/day for males, and 125 mg/kg body weight/day for females, based upon reductions in thymus weight.  In another 90-day sub-chronic study (OECD 411), dermal exposure to coker light gas oil resulted in a systemic LOAEL of 30 mg/kg body weight/day for males and females, based upon clinical signs and irritation noted at all doses. ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3c1aed0-4683-4a1f-9b68-7efa180561a6/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_94dcc6d6-7b19-470b-b9a6-7c09241159cd.html,,,,,, "Distillates (petroleum), hydrodesulfurized light catalytic cracked",68333-25-5,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3c1aed0-4683-4a1f-9b68-7efa180561a6/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_94dcc6d6-7b19-470b-b9a6-7c09241159cd.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), hydrodesulfurized light catalytic cracked",68333-25-5,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3c1aed0-4683-4a1f-9b68-7efa180561a6/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_94dcc6d6-7b19-470b-b9a6-7c09241159cd.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Distillates (petroleum), hydrodesulfurized light catalytic cracked",68333-25-5,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3c1aed0-4683-4a1f-9b68-7efa180561a6/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_94dcc6d6-7b19-470b-b9a6-7c09241159cd.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Distillates (petroleum), hydrodesulfurized light catalytic cracked",68333-25-5,"Acute Oral Toxicity:Acute oral toxicity of cracked gas oils was evaluated in male and female rats by a single oral gavage administration of a dose ranging from 2050 to 6250 mg/kg body weight.  Based on mortality and toxicity findings, an oral LD50 of 4660 mg/kg body weight and 3200 mg/kg body weight were reported for males and females, respectively.  Acute Inhalation Toxicity:Acute inhalation toxicity of cracked gas oils in rats was evaluated via whole-body exposure to test material at various measured concentrations for 4 hours.  The acute inhalation LC50 was 4.65 mg/L in males and females. Acute Dermal Toxicity:Acute dermal toxicity of cracked gas oils was evaluated in male and female rabbits at a single dose of 2000 mg/kg body weight.  Based on a lack of adverse systemic effects or mortality, the acute dermal LD50 for light catalytically cracked distillate was >2000 mg/kg body weight.   ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3c1aed0-4683-4a1f-9b68-7efa180561a6/documents/61f4e539-9411-462c-acca-769cdd71de1b_94dcc6d6-7b19-470b-b9a6-7c09241159cd.html,,,,,, "Distillates (petroleum), hydrodesulfurized light catalytic cracked",68333-25-5,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3c1aed0-4683-4a1f-9b68-7efa180561a6/documents/61f4e539-9411-462c-acca-769cdd71de1b_94dcc6d6-7b19-470b-b9a6-7c09241159cd.html,,oral,LD50,"3,200 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrodesulfurized light catalytic cracked",68333-25-5,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3c1aed0-4683-4a1f-9b68-7efa180561a6/documents/61f4e539-9411-462c-acca-769cdd71de1b_94dcc6d6-7b19-470b-b9a6-7c09241159cd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrodesulfurized light catalytic cracked",68333-25-5,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3c1aed0-4683-4a1f-9b68-7efa180561a6/documents/61f4e539-9411-462c-acca-769cdd71de1b_94dcc6d6-7b19-470b-b9a6-7c09241159cd.html,,inhalation,LC50,"4,650 mg/m3",adverse effect observed, Imidazolidine-2-thione,96-45-7," Short-term toxicity studies demonstrated that the thyroid gland is the most affected organ. Reduced T3 and T4 secretion and increased TSH (thyroid-stimulating hormone) secretion are found in rats. Ethylene thiourea may induce ultrastructural changes in the proximal tubuli of the rat kidneys. From these short-term studies, it can be concluded that the no-observed-adverse-effect level is of the order of 25 mg/kg diet (equivalent to 1.7 mg/kg body weight) and between 0.01 and 0.04 mg/l by inhalation. Two key studies are selected for this endpoint (for oral route). Freudenthal study showed the smallest NOAEL (1.7 mg/kg bw/d) and it was a subchronic study (90 days of exposure). ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53f2804b-8d5e-4979-ba05-8d64bb8532bf/documents/IUC5-9215ef56-21bb-4999-bacb-1efcf7637111_6d35862e-887e-482b-9756-15b682db9a4d.html,,,,,, Imidazolidine-2-thione,96-45-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53f2804b-8d5e-4979-ba05-8d64bb8532bf/documents/IUC5-9215ef56-21bb-4999-bacb-1efcf7637111_6d35862e-887e-482b-9756-15b682db9a4d.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,10 mg/m3,,rat Imidazolidine-2-thione,96-45-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53f2804b-8d5e-4979-ba05-8d64bb8532bf/documents/IUC5-9215ef56-21bb-4999-bacb-1efcf7637111_6d35862e-887e-482b-9756-15b682db9a4d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,1.7 mg/kg bw/day,,rat Imidazolidine-2-thione,96-45-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53f2804b-8d5e-4979-ba05-8d64bb8532bf/documents/IUC5-9215ef56-21bb-4999-bacb-1efcf7637111_6d35862e-887e-482b-9756-15b682db9a4d.html,Repeated dose toxicity – local effects,inhalation,NOAEC,40 mg/m3,no adverse effect observed,rat Imidazolidine-2-thione,96-45-7,"Acute oral toxicity studies indicated that rats are more susceptible to ETU than mice. The reported LD50 for ethylene thiourea given orally to rats is between 545 and 1832 mg/kg body weight. For oral doses to mice, the LD50 is more than 4000 mg/kg body weight. Ethylene thiourea is of low toxicity by the dermal route, with a dermal LD0 higher than 2000 mg/kg bw in rats. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53f2804b-8d5e-4979-ba05-8d64bb8532bf/documents/IUC5-04477d42-de1e-411f-b927-8a4a86b851af_6d35862e-887e-482b-9756-15b682db9a4d.html,,,,,, Imidazolidine-2-thione,96-45-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53f2804b-8d5e-4979-ba05-8d64bb8532bf/documents/IUC5-04477d42-de1e-411f-b927-8a4a86b851af_6d35862e-887e-482b-9756-15b682db9a4d.html,,oral,LD50,940 mg/kg bw,adverse effect observed, Imidazolidine-2-thione,96-45-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53f2804b-8d5e-4979-ba05-8d64bb8532bf/documents/IUC5-04477d42-de1e-411f-b927-8a4a86b851af_6d35862e-887e-482b-9756-15b682db9a4d.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,2-bis(2-methoxyethoxy)ethane",112-49-2,"A 29 day oral toxicity study was performed in rats. The animals were exposed to 0, 62.5, 250 and 1000 mg/kg bw/d. At 1000 mg/kg/d, males exhibited decreased testes and epididymides that correlated with microscopical indications of impaired spermatogenesis. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80234124-069c-4372-8c65-bb707960699a/documents/IUC5-0fc31a5a-bd1a-4c80-beef-a8b7c8141c85_31fcbc3b-53c5-4c30-8ae3-f605c043bd8c.html,,,,,, "1,2-bis(2-methoxyethoxy)ethane",112-49-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80234124-069c-4372-8c65-bb707960699a/documents/IUC5-0fc31a5a-bd1a-4c80-beef-a8b7c8141c85_31fcbc3b-53c5-4c30-8ae3-f605c043bd8c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "1,2-bis(2-methoxyethoxy)ethane",112-49-2,"Oral:- female rats, LD50: 5390 mg/kg bw- female rats, LD50: 5877 mg/kg bw- female mice, LD50: 4197 mg/kg bw (supporting data)Inhalation:- male/female rats, LC0 (Diethylene glycol dimethyl ether; 7h exposure): 11 mg/L -> 19.3 mg/L (4h calculated exposure)- male/female rats, LC0 (Ethylene glycol dimethyl ether; 1h exposure): 240 mg/L -> 60 mg/L (4h calculated exposure)- rats, LC50 (Ethylene glycol dimethyl ether; 6h exposure): > 20 mg/LDermal:- male rats, LD50: > 6900 mg/kg bw ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80234124-069c-4372-8c65-bb707960699a/documents/IUC5-fb4b4f27-b94e-4c4e-82cd-38d86cfb3f65_31fcbc3b-53c5-4c30-8ae3-f605c043bd8c.html,,,,,, "1,2-bis(2-methoxyethoxy)ethane",112-49-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80234124-069c-4372-8c65-bb707960699a/documents/IUC5-fb4b4f27-b94e-4c4e-82cd-38d86cfb3f65_31fcbc3b-53c5-4c30-8ae3-f605c043bd8c.html,,oral,LD50,"5,390 mg/kg bw",, "1,2-bis(2-methoxyethoxy)ethane",112-49-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80234124-069c-4372-8c65-bb707960699a/documents/IUC5-fb4b4f27-b94e-4c4e-82cd-38d86cfb3f65_31fcbc3b-53c5-4c30-8ae3-f605c043bd8c.html,,dermal,LD50,"6,900 mg/kg bw",, "N,N-dimethylaniline",121-69-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): K2 level data Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): K2 level data ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2dc58eea-9511-4f17-9f6e-8550ad1e6746/documents/IUC5-8199d816-ca19-4ca6-8e2e-d6d9486663fd_1648f874-46ad-4a0b-90a0-c476731bb955.html,,,,,, "N,N-dimethylaniline",121-69-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2dc58eea-9511-4f17-9f6e-8550ad1e6746/documents/IUC5-8199d816-ca19-4ca6-8e2e-d6d9486663fd_1648f874-46ad-4a0b-90a0-c476731bb955.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,32.6 mg/m3,,rat "N,N-dimethylaniline",121-69-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2dc58eea-9511-4f17-9f6e-8550ad1e6746/documents/IUC5-8199d816-ca19-4ca6-8e2e-d6d9486663fd_1648f874-46ad-4a0b-90a0-c476731bb955.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,31.25 mg/kg bw/day,,rat "N,N-dimethylaniline",121-69-7,"Acute toxicity oralThe acute toxicity by oral route was examined on 5 non-fasted, male Carworth-Wistar rats by gastric intubation. In this study, lethal dose (LD50) concentration was found to be 1348 mg/kg. Acute toxicity: inhalation Lowest lethal concentration (LCLo) by inhalation route of N,N-dimethylaniline to rat was found to be 250 mg/m3 indicating that the chemical is moderately toxic. Acute toxicity: dermalThe acute toxicity by dermal route was examined on the groups of 4 male New Zealand rabbits. All animals were tested using a technique similar to the Draize method. The dose was placed on clipped skin and retained beneath an impervious plastic film for 24 hours. The lethal dose (LD50) of N,N-dimethylaniline (LD50) was found to be 1692 mg/kg body weight. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2dc58eea-9511-4f17-9f6e-8550ad1e6746/documents/IUC5-b88b43aa-d590-40cd-8750-07c6bfd8e24c_1648f874-46ad-4a0b-90a0-c476731bb955.html,,,,,, "N,N-dimethylaniline",121-69-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2dc58eea-9511-4f17-9f6e-8550ad1e6746/documents/IUC5-b88b43aa-d590-40cd-8750-07c6bfd8e24c_1648f874-46ad-4a0b-90a0-c476731bb955.html,,oral,LD50,"1,348 mg/kg bw",adverse effect observed, "N,N-dimethylaniline",121-69-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2dc58eea-9511-4f17-9f6e-8550ad1e6746/documents/IUC5-b88b43aa-d590-40cd-8750-07c6bfd8e24c_1648f874-46ad-4a0b-90a0-c476731bb955.html,,dermal,LD50,"1,692 mg/kg bw",adverse effect observed, "N,N-dimethylaniline",121-69-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2dc58eea-9511-4f17-9f6e-8550ad1e6746/documents/IUC5-b88b43aa-d590-40cd-8750-07c6bfd8e24c_1648f874-46ad-4a0b-90a0-c476731bb955.html,,inhalation,,250 mg/m3,adverse effect observed, Malononitrile,109-77-3,"Study was conducted in compliance with the GLP-standards as set forth in title 40, of U.S. Code of Federal Regulation, part 160, with EPA, TOSCA GLP Regulation 40 CFR part 792.25 male and 25 female rats (28-day study) and 75 male and 75 female rats (90-day study) of the Crl: CD (SD) BR strain were used.Test article was formulated in water and administered orally by gavage, once daily. A constant dose volume of 10mg/kg/day (group 5) was used for 14 days.90-day study, treatment at 0.4 mg/kg/day was not associated with any toxicologically significant changes and can therefore be considered as the no-effect level for this compound in the rat.NOEL 0.4 mg/kg/bw/day. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/302c2966-4920-4a95-9615-fbea7ce083a3/documents/IUC5-c893f682-be47-4183-a343-90a459d47cd9_ca8f3c8a-57cf-4f23-af54-9c603f684f94.html,,,,,, Malononitrile,109-77-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/302c2966-4920-4a95-9615-fbea7ce083a3/documents/IUC5-c893f682-be47-4183-a343-90a459d47cd9_ca8f3c8a-57cf-4f23-af54-9c603f684f94.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,0.4 mg/kg bw/day,, Malononitrile,109-77-3,"Acute oral toxicity: Non-GLP, Limit test (Score 2)Species: Rat, CFHB strain (Wistar derived)1% w/v suspension in aqueous methylcellulose (1%), administered by oral intubation, dosage volumes 0.64 to 4.0 mg/kg bodyweight.LD50 and its 95% confidence limits were calculated by the method of Finney, D. J. (1952).Limit testAcute dermal toxicity: (realiable without restriction score 1)Key study according to GLP and in compliance with Directive 84/449 EEC, OECD Guideline No. 402 Method B.3Species: Rat, Spague-Dawley CFY StrainType of coverage: Semi occlusiveVehicle: Arachis OilDoses: 889 mg/kg, 1333 mg/kg, 3000 mg/kg ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/302c2966-4920-4a95-9615-fbea7ce083a3/documents/IUC5-b999a925-ca80-40f4-b710-12ab52605991_ca8f3c8a-57cf-4f23-af54-9c603f684f94.html,,,,,, Malononitrile,109-77-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/302c2966-4920-4a95-9615-fbea7ce083a3/documents/IUC5-b999a925-ca80-40f4-b710-12ab52605991_ca8f3c8a-57cf-4f23-af54-9c603f684f94.html,,oral,LD50,13.9 mg/kg bw,, Malononitrile,109-77-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/302c2966-4920-4a95-9615-fbea7ce083a3/documents/IUC5-b999a925-ca80-40f4-b710-12ab52605991_ca8f3c8a-57cf-4f23-af54-9c603f684f94.html,,dermal,LD50,"1,662 mg/kg bw",, "Fuel oil, residual",68476-33-5," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b55b8c9-7059-4f93-845d-e556e4f5e72a/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_2f46b45d-ab0c-4edc-85ed-7cc804c6a421.html,,,,,, "Fuel oil, residual",68476-33-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b55b8c9-7059-4f93-845d-e556e4f5e72a/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_2f46b45d-ab0c-4edc-85ed-7cc804c6a421.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Fuel oil, residual",68476-33-5,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b55b8c9-7059-4f93-845d-e556e4f5e72a/documents/12190120-6b6e-49c5-bed7-264eab246437_2f46b45d-ab0c-4edc-85ed-7cc804c6a421.html,,,,,, "Fuel oil, residual",68476-33-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b55b8c9-7059-4f93-845d-e556e4f5e72a/documents/12190120-6b6e-49c5-bed7-264eab246437_2f46b45d-ab0c-4edc-85ed-7cc804c6a421.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Fuel oil, residual",68476-33-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b55b8c9-7059-4f93-845d-e556e4f5e72a/documents/12190120-6b6e-49c5-bed7-264eab246437_2f46b45d-ab0c-4edc-85ed-7cc804c6a421.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fuel oil, residual",68476-33-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b55b8c9-7059-4f93-845d-e556e4f5e72a/documents/12190120-6b6e-49c5-bed7-264eab246437_2f46b45d-ab0c-4edc-85ed-7cc804c6a421.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, Naphthalene,91-20-3,"NOAEC(inhal.) of 5 mg/m3 could be identified for local respiratory effects from a 90d study.The NOAEC(90 d) for systemic respiratory effects was 300 mg/m3 (highest concentration tested).By the dermal route, a NOAEL for systemic toxicity of 1000 mg/kg/day (the highest dose tested) has been identified in a 90-day rat study. Slight changes at the treated skin site were noted.By the oral route, NOAELs in rat and mice for systemic effects were 200 mg/kg bw/d, based on the absence of histopathologic changes; however, based on unspecific clinical effects, the NOAELs came down to 100 mg/kg/day.(considered a NOEL) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ccd9f880-e75f-493c-86bd-0f8afc081031/documents/IUC5-e7d72277-5f20-4e6f-852e-f792ca5d44c0_7ea757d7-132d-4fed-bc4c-cc7baac56add.html,,,,,, Naphthalene,91-20-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ccd9f880-e75f-493c-86bd-0f8afc081031/documents/IUC5-e7d72277-5f20-4e6f-852e-f792ca5d44c0_7ea757d7-132d-4fed-bc4c-cc7baac56add.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Naphthalene,91-20-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ccd9f880-e75f-493c-86bd-0f8afc081031/documents/IUC5-e7d72277-5f20-4e6f-852e-f792ca5d44c0_7ea757d7-132d-4fed-bc4c-cc7baac56add.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat Naphthalene,91-20-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ccd9f880-e75f-493c-86bd-0f8afc081031/documents/IUC5-e7d72277-5f20-4e6f-852e-f792ca5d44c0_7ea757d7-132d-4fed-bc4c-cc7baac56add.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,300 mg/m3,,rat Naphthalene,91-20-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ccd9f880-e75f-493c-86bd-0f8afc081031/documents/IUC5-e7d72277-5f20-4e6f-852e-f792ca5d44c0_7ea757d7-132d-4fed-bc4c-cc7baac56add.html,Repeated dose toxicity – local effects,dermal,NOAEL,4 mg/cm2,adverse effect observed,rat Naphthalene,91-20-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ccd9f880-e75f-493c-86bd-0f8afc081031/documents/IUC5-e7d72277-5f20-4e6f-852e-f792ca5d44c0_7ea757d7-132d-4fed-bc4c-cc7baac56add.html,Repeated dose toxicity – local effects,inhalation,NOAEC,5 mg/m3,adverse effect observed,rat Naphthalene,91-20-3,"The oral LD50 values in male and female rats were 2200 and 2400 mg/kg (Gaines 1969) and 2600 in a study that did not differentiate by sex. LD50 values in male and female mice were 533 and 710 mg/kg, respectively (Shopp et al. 1984). Exposure to 77 ppm naphthalene for 4 hours by the inhalation route did not cause any deaths in rats. The LC50 for naphthalene vapour in Wistar albino rats is greater than 77.7 ppm, (0.4 mg/L) naphthalene (Fait 1985). No treatment-related deaths occurred within the 14-day observation period when naphthalene was applied at 2500 mg/kg to the skin of male and female rats (Gaines 1969) or when doses of up to 16,000 mg/kg were applied to the skin of male and female Sprague-Dawley rats for 24 hours (Korte 1980). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccd9f880-e75f-493c-86bd-0f8afc081031/documents/IUC5-33317e5f-9fe9-4fd4-bafb-da05be259f01_7ea757d7-132d-4fed-bc4c-cc7baac56add.html,,,,,, Naphthalene,91-20-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccd9f880-e75f-493c-86bd-0f8afc081031/documents/IUC5-33317e5f-9fe9-4fd4-bafb-da05be259f01_7ea757d7-132d-4fed-bc4c-cc7baac56add.html,,oral,LD50,533 mg/kg bw,adverse effect observed, Naphthalene,91-20-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccd9f880-e75f-493c-86bd-0f8afc081031/documents/IUC5-33317e5f-9fe9-4fd4-bafb-da05be259f01_7ea757d7-132d-4fed-bc4c-cc7baac56add.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, trans-dichloroethylene,156-60-5,"The NOAEC in a GLP guideline 90-day inhalation study was 4000 ppm (15859 mg/m3), the highest concentration tested in both male and female rats.The NOAEL in a GLP guideline 90-day oral feeding study was 3210 mg/kg bw/day and 3245 mg/kg bw/day in male and female rats, respectively, the highest doses tested for each sex. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/224fd64e-659e-4762-9da8-5c3b43626eae/documents/IUC5-9406f653-fd65-4a05-8b5d-5759dd9d046e_f9e6d864-c6cc-4253-bdc2-13c09250e96b.html,,,,,, trans-dichloroethylene,156-60-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/224fd64e-659e-4762-9da8-5c3b43626eae/documents/IUC5-9406f653-fd65-4a05-8b5d-5759dd9d046e_f9e6d864-c6cc-4253-bdc2-13c09250e96b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,210 mg/kg bw/day",,rat trans-dichloroethylene,156-60-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/224fd64e-659e-4762-9da8-5c3b43626eae/documents/IUC5-9406f653-fd65-4a05-8b5d-5759dd9d046e_f9e6d864-c6cc-4253-bdc2-13c09250e96b.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"15,859 mg/m3",,rat trans-dichloroethylene,156-60-5,Oral: Equivalent or similar to OECD Guideline 420. Rat LD50 = 7902 mg/kg males; 9939 mg/kg females. CNS depression. Reliability = 2Inhalation: OECD Guideline 403. Rat 4-hour LC50 ≥24100 ppm (≥95552 mg/m3). Diminished or lack of response to an alerting stimulus. Reliability = 1Dermal: Equivalent or similar to OECD 402. Rabbit LD50 >5000 mg/kg. Reliability = 1 ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/224fd64e-659e-4762-9da8-5c3b43626eae/documents/IUC5-a1aa5477-a9a3-47e5-b6ad-7c747e9ac3d2_f9e6d864-c6cc-4253-bdc2-13c09250e96b.html,,,,,, trans-dichloroethylene,156-60-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/224fd64e-659e-4762-9da8-5c3b43626eae/documents/IUC5-a1aa5477-a9a3-47e5-b6ad-7c747e9ac3d2_f9e6d864-c6cc-4253-bdc2-13c09250e96b.html,,oral,LD50,"7,902 mg/kg bw",no adverse effect observed, trans-dichloroethylene,156-60-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/224fd64e-659e-4762-9da8-5c3b43626eae/documents/IUC5-a1aa5477-a9a3-47e5-b6ad-7c747e9ac3d2_f9e6d864-c6cc-4253-bdc2-13c09250e96b.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, trans-dichloroethylene,156-60-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/224fd64e-659e-4762-9da8-5c3b43626eae/documents/IUC5-a1aa5477-a9a3-47e5-b6ad-7c747e9ac3d2_f9e6d864-c6cc-4253-bdc2-13c09250e96b.html,,inhalation,LC50,"95,552 mg/m3",no adverse effect observed, "Distillates (petroleum), straight-run light",68410-05-9,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/d32915c3-544c-41aa-a695-c2d41b433431/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_747a1522-d828-4c8d-b971-54dde725ea49.html,,,,,, "Distillates (petroleum), straight-run light",68410-05-9,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/d32915c3-544c-41aa-a695-c2d41b433431/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_747a1522-d828-4c8d-b971-54dde725ea49.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Distillates (petroleum), straight-run light",68410-05-9,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/d32915c3-544c-41aa-a695-c2d41b433431/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_747a1522-d828-4c8d-b971-54dde725ea49.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Distillates (petroleum), straight-run light",68410-05-9,"The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401)Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions)Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d32915c3-544c-41aa-a695-c2d41b433431/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_747a1522-d828-4c8d-b971-54dde725ea49.html,,,,,, "Distillates (petroleum), straight-run light",68410-05-9,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d32915c3-544c-41aa-a695-c2d41b433431/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_747a1522-d828-4c8d-b971-54dde725ea49.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), straight-run light",68410-05-9,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d32915c3-544c-41aa-a695-c2d41b433431/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_747a1522-d828-4c8d-b971-54dde725ea49.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), straight-run light",68410-05-9,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d32915c3-544c-41aa-a695-c2d41b433431/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_747a1522-d828-4c8d-b971-54dde725ea49.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha (petroleum), full-range reformed",68919-37-9,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c87cfde0-8165-41c8-a45e-9cc885f88454/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_7df20574-b736-4fb0-b5ed-3b34c43b0fd4.html,,,,,, "Naphtha (petroleum), full-range reformed",68919-37-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c87cfde0-8165-41c8-a45e-9cc885f88454/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_7df20574-b736-4fb0-b5ed-3b34c43b0fd4.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), full-range reformed",68919-37-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c87cfde0-8165-41c8-a45e-9cc885f88454/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_7df20574-b736-4fb0-b5ed-3b34c43b0fd4.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), full-range reformed",68919-37-9," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c87cfde0-8165-41c8-a45e-9cc885f88454/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_7df20574-b736-4fb0-b5ed-3b34c43b0fd4.html,,,,,, "Naphtha (petroleum), full-range reformed",68919-37-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c87cfde0-8165-41c8-a45e-9cc885f88454/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_7df20574-b736-4fb0-b5ed-3b34c43b0fd4.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), full-range reformed",68919-37-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c87cfde0-8165-41c8-a45e-9cc885f88454/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_7df20574-b736-4fb0-b5ed-3b34c43b0fd4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), full-range reformed",68919-37-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c87cfde0-8165-41c8-a45e-9cc885f88454/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_7df20574-b736-4fb0-b5ed-3b34c43b0fd4.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha (petroleum), sweetened light",101795-01-1,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/93562eba-34ed-473d-90be-1cc7a99deefe/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_82c0a245-b277-4129-b915-759f8009f9f9.html,,,,,, "Naphtha (petroleum), sweetened light",101795-01-1,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/93562eba-34ed-473d-90be-1cc7a99deefe/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_82c0a245-b277-4129-b915-759f8009f9f9.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), sweetened light",101795-01-1,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/93562eba-34ed-473d-90be-1cc7a99deefe/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_82c0a245-b277-4129-b915-759f8009f9f9.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), sweetened light",101795-01-1,"The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401)Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions)Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93562eba-34ed-473d-90be-1cc7a99deefe/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_82c0a245-b277-4129-b915-759f8009f9f9.html,,,,,, "Naphtha (petroleum), sweetened light",101795-01-1,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93562eba-34ed-473d-90be-1cc7a99deefe/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_82c0a245-b277-4129-b915-759f8009f9f9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), sweetened light",101795-01-1,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93562eba-34ed-473d-90be-1cc7a99deefe/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_82c0a245-b277-4129-b915-759f8009f9f9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), sweetened light",101795-01-1,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93562eba-34ed-473d-90be-1cc7a99deefe/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_82c0a245-b277-4129-b915-759f8009f9f9.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha (petroleum), isomerization",64741-70-4,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/59fec465-c965-406f-86b7-0f9173865277/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_a80f0b25-23e7-4fc2-8ba3-95145260af8e.html,,,,,, "Naphtha (petroleum), isomerization",64741-70-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/59fec465-c965-406f-86b7-0f9173865277/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_a80f0b25-23e7-4fc2-8ba3-95145260af8e.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), isomerization",64741-70-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/59fec465-c965-406f-86b7-0f9173865277/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_a80f0b25-23e7-4fc2-8ba3-95145260af8e.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), isomerization",64741-70-4," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59fec465-c965-406f-86b7-0f9173865277/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_a80f0b25-23e7-4fc2-8ba3-95145260af8e.html,,,,,, "Naphtha (petroleum), isomerization",64741-70-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59fec465-c965-406f-86b7-0f9173865277/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_a80f0b25-23e7-4fc2-8ba3-95145260af8e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), isomerization",64741-70-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59fec465-c965-406f-86b7-0f9173865277/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_a80f0b25-23e7-4fc2-8ba3-95145260af8e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), isomerization",64741-70-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59fec465-c965-406f-86b7-0f9173865277/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_a80f0b25-23e7-4fc2-8ba3-95145260af8e.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Tar, coal, high-temp.",65996-89-6," In a 6-months feeding study, mice received a by-product from coal gasification, a coal-tar material. Body weight was retarded at a dietary level of 0.25 % [>= 200 mg/(kg bw*d)], mainly due to reduced food intake. No gross or histopathological lesions were observed up to the highest concentration in the feed of 0.5 % [>= 350 mg/kg bw*d)]. Observed histopathological effects were sporadic and not considered treatment-related. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/780c8d4e-ab3d-4b8f-a05e-c5e142076186/documents/IUC5-29a78a0d-55b9-45dd-a1c1-270a3b9cecc1_23d0cb5c-e740-4a47-9fe3-753c3593b85b.html,,,,,, "Tar, coal, high-temp.",65996-89-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/780c8d4e-ab3d-4b8f-a05e-c5e142076186/documents/IUC5-29a78a0d-55b9-45dd-a1c1-270a3b9cecc1_23d0cb5c-e740-4a47-9fe3-753c3593b85b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,350 mg/kg bw/day,, "Tar, coal, high-temp.",65996-89-6,The oral LD50 of coal tar is greater than 2000 mg/kg bw in rats. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/780c8d4e-ab3d-4b8f-a05e-c5e142076186/documents/IUC5-4620b15f-f7f1-4b06-b1c9-daaf40532209_23d0cb5c-e740-4a47-9fe3-753c3593b85b.html,,,,,, "Distillates (coal tar), heavy oils",90640-86-1,"No experimental data on repeated dose toxicity is available for AOH itself. Results from a related total petroleum hydrocarbon aromatic mixture (>EC9 to EC16 TPH fraction) and from a structure-related tar oil are used to characterise the repeated dose toxicity of AOH. Oral repeated dose toxicity is based on a TDI value derived for the aromatic TPH fraction while for inhalation repeated dose toxicity, a NOAEC of the structure related tar oil creosote is adopted.Dominant human health effect of AOH is not repeated dose toxicity but carcinogenicity due to its content of benzo[a]pyrene. Therefore, risk assessment will not be based on repeated dose toxicity but on the carcinogenic effect of benzo[a]pyrene. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d008d077-643b-45ea-a4e3-31cc67f15031/documents/IUC5-6550b33e-74ab-4ad3-ac4b-102814361671_c47d6b97-62d8-4cc7-a093-76c3a1f2f64c.html,,,,,, "Distillates (coal tar), heavy oils",90640-86-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d008d077-643b-45ea-a4e3-31cc67f15031/documents/IUC5-6550b33e-74ab-4ad3-ac4b-102814361671_c47d6b97-62d8-4cc7-a093-76c3a1f2f64c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,mouse "Distillates (coal tar), heavy oils",90640-86-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d008d077-643b-45ea-a4e3-31cc67f15031/documents/IUC5-6550b33e-74ab-4ad3-ac4b-102814361671_c47d6b97-62d8-4cc7-a093-76c3a1f2f64c.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,22 mg/m3,,rat "Distillates (coal tar), heavy oils",90640-86-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d008d077-643b-45ea-a4e3-31cc67f15031/documents/IUC5-6550b33e-74ab-4ad3-ac4b-102814361671_c47d6b97-62d8-4cc7-a093-76c3a1f2f64c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,22 mg/m3,adverse effect observed,rat "Distillates (coal tar), heavy oils",90640-86-1,"No acute toxicity was observed after single oral, dermal and inhalational administration of the supporting substance creosote to rats thus characterising AOH by analogy as not being acutely toxic. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d008d077-643b-45ea-a4e3-31cc67f15031/documents/IUC5-e8599da6-a068-4430-9f16-b6e763a5226d_c47d6b97-62d8-4cc7-a093-76c3a1f2f64c.html,,,,,, "Distillates (coal tar), heavy oils",90640-86-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d008d077-643b-45ea-a4e3-31cc67f15031/documents/IUC5-e8599da6-a068-4430-9f16-b6e763a5226d_c47d6b97-62d8-4cc7-a093-76c3a1f2f64c.html,,oral,LD50,"4,030 mg/kg bw",no adverse effect observed, "Distillates (coal tar), heavy oils",90640-86-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d008d077-643b-45ea-a4e3-31cc67f15031/documents/IUC5-e8599da6-a068-4430-9f16-b6e763a5226d_c47d6b97-62d8-4cc7-a093-76c3a1f2f64c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Distillates (coal tar), heavy oils",90640-86-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d008d077-643b-45ea-a4e3-31cc67f15031/documents/IUC5-e8599da6-a068-4430-9f16-b6e763a5226d_c47d6b97-62d8-4cc7-a093-76c3a1f2f64c.html,,inhalation,discriminating conc.,"5,000 mg/m3",no adverse effect observed, "Hydrocarbons, C5-11, nonaroms.-rich, reforming light fraction",93572-36-2,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8356a835-7e2c-4315-8eca-2f0dda7e531e/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_8cbc444e-ab8a-4b47-882a-680b58b2c686.html,,,,,, "Hydrocarbons, C5-11, nonaroms.-rich, reforming light fraction",93572-36-2,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8356a835-7e2c-4315-8eca-2f0dda7e531e/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_8cbc444e-ab8a-4b47-882a-680b58b2c686.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Hydrocarbons, C5-11, nonaroms.-rich, reforming light fraction",93572-36-2,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8356a835-7e2c-4315-8eca-2f0dda7e531e/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_8cbc444e-ab8a-4b47-882a-680b58b2c686.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Hydrocarbons, C5-11, nonaroms.-rich, reforming light fraction",93572-36-2,"The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401)Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions)Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8356a835-7e2c-4315-8eca-2f0dda7e531e/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_8cbc444e-ab8a-4b47-882a-680b58b2c686.html,,,,,, "Hydrocarbons, C5-11, nonaroms.-rich, reforming light fraction",93572-36-2,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8356a835-7e2c-4315-8eca-2f0dda7e531e/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_8cbc444e-ab8a-4b47-882a-680b58b2c686.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C5-11, nonaroms.-rich, reforming light fraction",93572-36-2,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8356a835-7e2c-4315-8eca-2f0dda7e531e/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_8cbc444e-ab8a-4b47-882a-680b58b2c686.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C5-11, nonaroms.-rich, reforming light fraction",93572-36-2,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8356a835-7e2c-4315-8eca-2f0dda7e531e/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_8cbc444e-ab8a-4b47-882a-680b58b2c686.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",2451-62-9,"In a 90-day oral toxicity study in rats the NOAEL was determined to be 1.05 mg/kg/day, based on hematological effects and effects in the mesentheric lymph nodes. Dosing up to 50 mg/kg/day caused severe body weight reduction, and lymphoid depletion of spleen and thymus.In a 5-day mouse inhalation study with exposures for 6 hours per day, at 100, 300 and 750 mg/m3 air caused significant mortality but exposure was too short to see organ effects. No NOAEL was established indicating that the NOAEL is < 100 mg/m3 air.In a 26-week skin -tumour promotion study no toxic effects were observed apart from acanthosis at the application site indicating that TGIC did not penetrate the skin in significant amounts except to cause irritqtion and sensitization.A study with mice , dogs, guinea pigs and white rabbits using the intravenous route of exposure, showed mortality, reduced organ weights, haematological effects and signs of neurotoxicity especially in dogs. However, dosing was too short (5 daily injections) to get a clear picture of the neurological effects. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34e6733b-1fe6-4909-8af3-f1a653172794/documents/IUC5-b5f6877e-f0bf-41ca-abda-c42e4c07344e_007ecc26-4936-4c00-b7b7-77cde47eab34.html,,,,,, "1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",2451-62-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34e6733b-1fe6-4909-8af3-f1a653172794/documents/IUC5-b5f6877e-f0bf-41ca-abda-c42e4c07344e_007ecc26-4936-4c00-b7b7-77cde47eab34.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,1.05 mg/kg bw/day,, "1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",2451-62-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34e6733b-1fe6-4909-8af3-f1a653172794/documents/IUC5-b5f6877e-f0bf-41ca-abda-c42e4c07344e_007ecc26-4936-4c00-b7b7-77cde47eab34.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,200 mg/kg bw/day,, "1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",2451-62-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34e6733b-1fe6-4909-8af3-f1a653172794/documents/IUC5-b5f6877e-f0bf-41ca-abda-c42e4c07344e_007ecc26-4936-4c00-b7b7-77cde47eab34.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,25 mg/m3,, "1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",2451-62-9,"The acute oral toxicity in rats is between 400 and 800 mg/kg bw for male and female. LD50 for acute oral toxicity is 400 mg/kg bw.The acute dermal toxicity of TGIC is low , the LD50 is >2000 mg/kg bw for both genders.The lowest acute inhalation toxicity value in rats is 1083 mg/m3 air for female rats while for male rats the value is 5040 mg/m3 air. Then the LC50 for acute inhalation is 3400 mg/m3 air. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34e6733b-1fe6-4909-8af3-f1a653172794/documents/IUC5-5224c861-d5b7-4dac-9e82-2e38763c116c_007ecc26-4936-4c00-b7b7-77cde47eab34.html,,,,,, "1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",2451-62-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34e6733b-1fe6-4909-8af3-f1a653172794/documents/IUC5-5224c861-d5b7-4dac-9e82-2e38763c116c_007ecc26-4936-4c00-b7b7-77cde47eab34.html,,oral,LD50,400 mg/kg bw,adverse effect observed, "1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",2451-62-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34e6733b-1fe6-4909-8af3-f1a653172794/documents/IUC5-5224c861-d5b7-4dac-9e82-2e38763c116c_007ecc26-4936-4c00-b7b7-77cde47eab34.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3,5-tris(oxiranylmethyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",2451-62-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34e6733b-1fe6-4909-8af3-f1a653172794/documents/IUC5-5224c861-d5b7-4dac-9e82-2e38763c116c_007ecc26-4936-4c00-b7b7-77cde47eab34.html,,inhalation,LC50,"3,400 mg/m3",adverse effect observed, "Hydrocarbons, C4",87741-01-3,"Only one stream (Liquified Petroleum Gases CAS 68476 -85 -7) of the Other Petroleum Gases category has been tested but this and the main constituents of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and humans. The mammalian toxicity effects of this category will be driven by the content of benzene if the latter is present at levels of >10%. Additionally, the category may contain carbon monoxide which could trigger classification.   ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5217073-9ca4-4bdc-8a75-f586d792f4e2/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_da68dfd7-e371-47d0-969c-1a01fa2c6c05.html,,,,,, "Hydrocarbons, C4",87741-01-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5217073-9ca4-4bdc-8a75-f586d792f4e2/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_da68dfd7-e371-47d0-969c-1a01fa2c6c05.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"7,214 mg/m3",,rat "Hydrocarbons, C4",87741-01-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5217073-9ca4-4bdc-8a75-f586d792f4e2/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_da68dfd7-e371-47d0-969c-1a01fa2c6c05.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"8,600 mg/m3",adverse effect observed,rat "Hydrocarbons, C4",87741-01-3,"Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the constituents. Across species, main constituent gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene in streams where it is present at levels of <1%. However, some streams in this category may contain benzene levels >1% or carbon monoxide which could trigger classification. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5217073-9ca4-4bdc-8a75-f586d792f4e2/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_da68dfd7-e371-47d0-969c-1a01fa2c6c05.html,,,,,, "Hydrocarbons, C4",87741-01-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5217073-9ca4-4bdc-8a75-f586d792f4e2/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_da68dfd7-e371-47d0-969c-1a01fa2c6c05.html,,inhalation,LC50,"22,948 mg/m3",no adverse effect observed, Indium phosphide,22398-80-7,"  Two GLP studies using a method similar to the OECD TG 413 (with deviations) were conducted to evaluate the repeated dose toxicity potential of indium phosphide via inhalation. Groups of 10 Male and 10 female B6C3F1 mice and F344/N rats were exposed to particulate aerosols of indium phosphide at concentrations of 0, 1, 3, 10, 30, or 100 mg/m3 for 6 hours per day, 5 days per week (weeks 1 to 4 and weeks 10 to 14) or 7 days per week (weeks 5 to 9). Results showed that mice were more severely affected than rats. All the mice in the 100 mg/m3 exposed groups and one male and three females in the 30 mg/m3 groups either died or were removed moribund. In contrast, only one male rat in the 100 mg/m3 exposed group died early. Mean body weight gains of rats and mice exposed to 100 mg/m3 and mice exposed to 10 or 30 mg/m3 were significantly less than those of the chamber controls. The principal site of toxicity was established to be the respiratory tract based on the presence of indium particles, increased lung weights and a spectrum of inflammatory and proliferative lesions in the lungs of most exposed rats and mice. While the lung lesions observed were similar, both species presented qualitative and quantitative differences where the lesions in mice were frequently more severe at comparable exposure concentrations to those of rats. Furthermore, pulmonary interstitial fibrosis known as a common response to particulate exposure in rats and uncommon in mice, was found in mice. Indium exposure caused a reactive hyperplasia in the respiratory tract lymph nodes in both mice and rats and chronic inflammation in the larynx of rats. The larynx of mice was more severely affected as the hyperplasia was accompanied by focal necrosis and squamous metaplasia. The lungs of both rats and mice were discoloured and enlarged 2.7 to 4.4 and 2.6 to 4.1 (rats and mice respectively) compared to chamber controls where inflammation was seen to be more severe in mice than rats. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d7ad988-7784-4cb3-a8d2-f8cdcf01d0c4/documents/8b6f3c0e-79ec-40b3-847c-f3aaeebf24c0_8665f4e6-598c-4f1a-8a22-4dd178f0965e.html,,,,,, Indium phosphide,22398-80-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d7ad988-7784-4cb3-a8d2-f8cdcf01d0c4/documents/8b6f3c0e-79ec-40b3-847c-f3aaeebf24c0_8665f4e6-598c-4f1a-8a22-4dd178f0965e.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,1 mg/m3,,mouse Indium phosphide,22398-80-7," An acute oral toxicity study was performed on Indium Phosphide according to a method similar to the OECD TG 420. Four-week-old Male ICR mice (SPF grade) were given a single dose of 0, 1,000, 3,000 or 5,000 mg/kg bw of Indium Phosphide (99.999% Purity) as a powder in physiological saline solution. Following the exposure observations of behaviour, body weight and external appearance were made for two weeks. Ensuing the observation period, the mice were sacrificed and their blood was collected for analysis, and their kidneys, lungs, spleen, liver and testes were all observed and weighed. Indium concentrations observed in organs were compared to those of the control and higher dose groups. No mice died due to oral exposure to Indium Phosphide. No changes in external appearance, behaviour and body weights among the groups were observed. Traces of indium phosphide were detected in the serum, liver and kidneys, however no clear increases of the weight of these organs were recorded. A decrease of the blood urea nitrogen proportionate to the increased exposure concentration was noted. Finally, colour change on the lung surface of numerous mice were observed. Considering that Indium Phosphide has a LD50 > 5,000 mg/kg bw, it does not meet the criteria for classification according to Regulation 1272/2008. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d7ad988-7784-4cb3-a8d2-f8cdcf01d0c4/documents/ad43dde2-807a-4d99-b680-1dff7da96065_8665f4e6-598c-4f1a-8a22-4dd178f0965e.html,,,,,, Indium phosphide,22398-80-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d7ad988-7784-4cb3-a8d2-f8cdcf01d0c4/documents/ad43dde2-807a-4d99-b680-1dff7da96065_8665f4e6-598c-4f1a-8a22-4dd178f0965e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",15571-58-1,"In the key study (Anonymous, 1970) repeated dose oral toxicity of a mixture of Dioctyltin bis(2-EHMA) [CAS No. 15571-58-1]:Octyltin tris(2-EHMA) [CAS No. 27107-89-7]: Trioctyltin (2-EHMA) [CAS No. 61912-55-8] (97.0:0.3:2.17% mixture) was evaluated in rats dosed continuously via the diet at concentrations of 10, 25, 50, 250, 100, 500 and 1000 ppm. Under the conditions of the study the no-observable-adverse-effect-level (NOAEL) was determined to be 10 ppm in the diet (equivalent to 0.5 mg/kg/bw/day) of rats exposed for 90 days, on the basis of reduced thymus weight at 25 ppm.   ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9af4e461-4173-45e8-925d-038a08e6abe0/documents/IUC5-da20a53f-0861-4485-b589-2b047e09a0de_5bf37f5d-67dd-453d-b829-bf628596d347.html,,,,,, "2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",15571-58-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9af4e461-4173-45e8-925d-038a08e6abe0/documents/IUC5-da20a53f-0861-4485-b589-2b047e09a0de_5bf37f5d-67dd-453d-b829-bf628596d347.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.5 mg/kg bw/day,,rat "2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",15571-58-1,"-Acute oral: The LD50 was lower than 2000 mg/kg for female rats, the overall LD50 for males and females was 2000 mg/kg bw (lower 95% confidence limit= 1265 mg/kg/bw) -Acute dermal: The LD50 of the test substance was reported as: LD50 (both sexes) >2000 mg/kg bw. -Acute inhalation: The acute inhalation testing does not need to be conducted as acute toxicity tests by two other appropriate routes of exposure are available. Furthermore, the test substance is a liquid with no expected inhalation exposure (boiling point > 300 °C). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9af4e461-4173-45e8-925d-038a08e6abe0/documents/IUC5-15abd82f-3a42-4e58-a7e3-676fcad9a7c3_5bf37f5d-67dd-453d-b829-bf628596d347.html,,,,,, "2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",15571-58-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9af4e461-4173-45e8-925d-038a08e6abe0/documents/IUC5-15abd82f-3a42-4e58-a7e3-676fcad9a7c3_5bf37f5d-67dd-453d-b829-bf628596d347.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",15571-58-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9af4e461-4173-45e8-925d-038a08e6abe0/documents/IUC5-15abd82f-3a42-4e58-a7e3-676fcad9a7c3_5bf37f5d-67dd-453d-b829-bf628596d347.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-ethylhexyl 10-ethyl-4,4-dimethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",57583-35-4," 90-day repeat dose oral toxicity study combined with a neurotoxicity test, Kumar (2020) Under the conditions of the study, the no observed-adverse-effect level (NOAEL) is 60 ppm in the diet (approximately 5.74 mg/kg/day) in females and 175 ppm in diet (14.96 mg/kg/day) in males. 28-day repeat dose oral toxicity study combined with a neurotoxicity test, Kumar (2019) Under the conditions of this study, it is concluded that the no-observed adverse-effect level (NOAEL) is less than 175 ppm in the diet (approximately 20 mg/kg/day in males and 22 mg/kg/day in females). ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3944f297-8d3d-4d0a-93d5-ccb88b44cd57/documents/IUC5-7237c19f-0514-40e5-98cd-56bcff0f4bcb_c10a78ad-2cde-4788-9485-e3c2a2625278.html,,,,,, "2-ethylhexyl 10-ethyl-4,4-dimethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",57583-35-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3944f297-8d3d-4d0a-93d5-ccb88b44cd57/documents/IUC5-7237c19f-0514-40e5-98cd-56bcff0f4bcb_c10a78ad-2cde-4788-9485-e3c2a2625278.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5.74 mg/kg bw/day,,rat "2-ethylhexyl 10-ethyl-4,4-dimethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",57583-35-4, Acute oral LD50 1150 mg/kg bw in rats (OECD 401) Acute dermal LD50 >1050 mg/kg bw in rabbits (OECD 402) ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3944f297-8d3d-4d0a-93d5-ccb88b44cd57/documents/IUC5-2ff28fae-245f-46c6-bfeb-829e7455b5a1_c10a78ad-2cde-4788-9485-e3c2a2625278.html,,,,,, "2-ethylhexyl 10-ethyl-4,4-dimethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",57583-35-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3944f297-8d3d-4d0a-93d5-ccb88b44cd57/documents/IUC5-2ff28fae-245f-46c6-bfeb-829e7455b5a1_c10a78ad-2cde-4788-9485-e3c2a2625278.html,,oral,LD50,"1,150 mg/kg bw",adverse effect observed, "2-ethylhexyl 10-ethyl-4,4-dimethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",57583-35-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3944f297-8d3d-4d0a-93d5-ccb88b44cd57/documents/IUC5-2ff28fae-245f-46c6-bfeb-829e7455b5a1_c10a78ad-2cde-4788-9485-e3c2a2625278.html,,dermal,LD50,"1,050 mg/kg bw",adverse effect observed, Cadmium nitrate,10325-94-7,"Available NOAELs from repeated dose oral and inhalation studies range between 0.12 - 3 mg/kg bw/day (studies with cadmium chloride) and 0.013. 10-3- 0.022 x 10-3mg/L (studies with cadmium oxide), respectively.Repeated dose toxicity of cadmium via the dermal route is not expected given the relatively low skin penetration of all forms of this metal. Also in view of the risk reduction measures which need to be taken as a result of the carcinogenicity of cadmium metal and some of the cadmium compounds, chronic dermal toxicity is not expected to be an issue for human health. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aadeb325-db55-4588-9d5b-cb654ce18459/documents/IUC5-4cdedf66-8635-4116-b2a3-cc8fa73a4a4c_cf06861e-84c2-4551-afe7-60da5fb2b783.html,,,,,, Cadmium nitrate,10325-94-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aadeb325-db55-4588-9d5b-cb654ce18459/documents/IUC5-4cdedf66-8635-4116-b2a3-cc8fa73a4a4c_cf06861e-84c2-4551-afe7-60da5fb2b783.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.013 mg/m3,,"hamster, Syrian" Cadmium nitrate,10325-94-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aadeb325-db55-4588-9d5b-cb654ce18459/documents/IUC5-4cdedf66-8635-4116-b2a3-cc8fa73a4a4c_cf06861e-84c2-4551-afe7-60da5fb2b783.html,Chronic toxicity – systemic effects,oral,NOAEL,0.12 mg/kg bw/day,,monkey Cadmium nitrate,10325-94-7,"When administered orally, the water soluble cadmium chloride caused mortality at relatively low doses, with LD50s in mouse and rat ranging from 29 to 327 mg Cd/kg bw. On this basis, cadmium chloride has been classified asT; R25 (toxic if swallowed) in Annex I of Directive 67/548/EEC.Under GHS-CLP, the corresponding classification would be ‘Acute toxicity (oral) category 3; H301’. Although no animal studies are available, cadmium sulphate is also classified in Annex I asT; R25, which is justified given its comparable solubility to cadmium chloride. Cadmium nitrate, also highly water soluble, is at present not classified for acute oral toxicity but a similar classification should be considered. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aadeb325-db55-4588-9d5b-cb654ce18459/documents/IUC5-6889bc17-27b2-4307-92bb-6b679eb83465_cf06861e-84c2-4551-afe7-60da5fb2b783.html,,,,,, Cadmium nitrate,10325-94-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aadeb325-db55-4588-9d5b-cb654ce18459/documents/IUC5-6889bc17-27b2-4307-92bb-6b679eb83465_cf06861e-84c2-4551-afe7-60da5fb2b783.html,,oral,LD50,225 mg/kg bw,, Cadmium nitrate,10325-94-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aadeb325-db55-4588-9d5b-cb654ce18459/documents/IUC5-6889bc17-27b2-4307-92bb-6b679eb83465_cf06861e-84c2-4551-afe7-60da5fb2b783.html,,inhalation,LC50,56 mg/m3,, Potassium chromate,7789-00-6,High quality (NTP) studies using oral dosing are available for sodium dichromate and potassium dichromate in the rat and mouse.  Repeated dose inhalation exposure studies are available for chromium trioxide.  Longer term toxicity and carcinogenicity studies are also availabel for compounds in this group ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6440e7b2-77bd-4f30-a834-bbd395b3767e/documents/IUC5-3f8d541f-7a53-42d4-a853-e5ebfe57f595_44a0ab36-3720-4861-ba7b-23fd3c6fb36b.html,,,,,, Potassium chromate,7789-00-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6440e7b2-77bd-4f30-a834-bbd395b3767e/documents/IUC5-3f8d541f-7a53-42d4-a853-e5ebfe57f595_44a0ab36-3720-4861-ba7b-23fd3c6fb36b.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,1.7 mg/kg bw/day,, Potassium chromate,7789-00-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6440e7b2-77bd-4f30-a834-bbd395b3767e/documents/IUC5-3f8d541f-7a53-42d4-a853-e5ebfe57f595_44a0ab36-3720-4861-ba7b-23fd3c6fb36b.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,1.81 mg/m3,, Potassium chromate,7789-00-6,"Proprietary (guideline & GLP-compliant) acute oral, dermal and inhalation studies are available for cthe compounds in this group.  A number ofadditional published studies have been reviewed by the UK Health & Safety Executive (HSE, 1989), the UK Institute of Occupational Health (IOH, 1997) and the EU RAR (2005).  The EU RAR also covers the studies previously reviewed in the other two reports. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6440e7b2-77bd-4f30-a834-bbd395b3767e/documents/IUC5-73b63e56-1a59-4e5a-8b1d-e90cfeb63603_44a0ab36-3720-4861-ba7b-23fd3c6fb36b.html,,,,,, Potassium chromate,7789-00-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6440e7b2-77bd-4f30-a834-bbd395b3767e/documents/IUC5-73b63e56-1a59-4e5a-8b1d-e90cfeb63603_44a0ab36-3720-4861-ba7b-23fd3c6fb36b.html,,oral,LD50,59 mg/kg bw,, Potassium chromate,7789-00-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6440e7b2-77bd-4f30-a834-bbd395b3767e/documents/IUC5-73b63e56-1a59-4e5a-8b1d-e90cfeb63603_44a0ab36-3720-4861-ba7b-23fd3c6fb36b.html,,dermal,LD50,"2,000 mg/kg bw",, Potassium chromate,7789-00-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6440e7b2-77bd-4f30-a834-bbd395b3767e/documents/IUC5-73b63e56-1a59-4e5a-8b1d-e90cfeb63603_44a0ab36-3720-4861-ba7b-23fd3c6fb36b.html,,inhalation,LC50,200 mg/m3,, "Hydrocarbons, C5-rich, dicyclopentadiene-contg.",102110-15-6," Oral and inhalation exposure to dicyclopentadiene resulted in nephrotoxicity (alterations in renal function and kidney morphology) in male rats only and characteristic of hyaline droplet nephropathy, which is not relevant for human risk assessment. Mortality was seen in rats dosed with 100 mg/kg/day orally and in mice exposed to 51 ppm by inhalation. Apart from the effects on the kidney (in male rats only), there were few histopathological changes. Single cell necrosis in the liver and fatty changes in the adrenal glands were seen in the oral rat study only. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8eeca741-9917-44ce-bdf0-ff8b5aecc061/documents/6638dc1d-1b6e-4a20-92fb-c4f98950b7a3_d3d25124-05bb-4afd-a911-d96e434fa764.html,,,,,, "Hydrocarbons, C5-rich, dicyclopentadiene-contg.",102110-15-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8eeca741-9917-44ce-bdf0-ff8b5aecc061/documents/6638dc1d-1b6e-4a20-92fb-c4f98950b7a3_d3d25124-05bb-4afd-a911-d96e434fa764.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,4 mg/kg bw/day,,rat "Hydrocarbons, C5-rich, dicyclopentadiene-contg.",102110-15-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8eeca741-9917-44ce-bdf0-ff8b5aecc061/documents/6638dc1d-1b6e-4a20-92fb-c4f98950b7a3_d3d25124-05bb-4afd-a911-d96e434fa764.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,27.6 mg/m3,,mouse "Hydrocarbons, C5-rich, dicyclopentadiene-contg.",102110-15-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8eeca741-9917-44ce-bdf0-ff8b5aecc061/documents/6638dc1d-1b6e-4a20-92fb-c4f98950b7a3_d3d25124-05bb-4afd-a911-d96e434fa764.html,Repeated dose toxicity – local effects,inhalation,NOAEC,27.6 mg/m3,adverse effect observed,mouse "Hydrocarbons, C5-rich, dicyclopentadiene-contg.",102110-15-6," Dicyclopentadiene is of slight - moderate acute toxicity by the oral and inhalation routes (oral LD50 590 mg/kg, inhalation 4 hour LC50 1972 mg/m3) and is practically non-toxic by the dermal route (dermal LD50 > 2000 mg/kg). The NOAEC for irregular breathing, stereotypic behaviour in rats and mice has been reported to be 248.74 mg/m3 (Bushy Run, 1981). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8eeca741-9917-44ce-bdf0-ff8b5aecc061/documents/dc8b9970-d740-4a52-b27b-f2e87859f30d_d3d25124-05bb-4afd-a911-d96e434fa764.html,,,,,, "Hydrocarbons, C5-rich, dicyclopentadiene-contg.",102110-15-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8eeca741-9917-44ce-bdf0-ff8b5aecc061/documents/dc8b9970-d740-4a52-b27b-f2e87859f30d_d3d25124-05bb-4afd-a911-d96e434fa764.html,,oral,LD50,590 mg/kg bw,adverse effect observed, "Hydrocarbons, C5-rich, dicyclopentadiene-contg.",102110-15-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8eeca741-9917-44ce-bdf0-ff8b5aecc061/documents/dc8b9970-d740-4a52-b27b-f2e87859f30d_d3d25124-05bb-4afd-a911-d96e434fa764.html,,inhalation,LC50,"1,972 mg/m3",adverse effect observed, "1,3-diphenylguanidine",102-06-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): No reliable study is available for this endpoint. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): It is a reliable study with a klimisch score of 1 ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85a7482d-61f5-4625-b9b7-22bbafb256ee/documents/84abe75b-34af-4700-bb4d-e1cb406372db_90e60b99-7bbd-419e-abd3-7b4ce8742598.html,,,,,, "1,3-diphenylguanidine",102-06-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85a7482d-61f5-4625-b9b7-22bbafb256ee/documents/84abe75b-34af-4700-bb4d-e1cb406372db_90e60b99-7bbd-419e-abd3-7b4ce8742598.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat "1,3-diphenylguanidine",102-06-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The key study is a reliable study and has a klimish score of 1. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): No reliable study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The key study is a reliable study and has a klimish score of 1. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85a7482d-61f5-4625-b9b7-22bbafb256ee/documents/6a2ac65b-5301-4c10-8754-561d3f148ed0_90e60b99-7bbd-419e-abd3-7b4ce8742598.html,,,,,, "1,3-diphenylguanidine",102-06-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85a7482d-61f5-4625-b9b7-22bbafb256ee/documents/6a2ac65b-5301-4c10-8754-561d3f148ed0_90e60b99-7bbd-419e-abd3-7b4ce8742598.html,,oral,LD50,107 mg/kg bw,adverse effect observed, "1,3-diphenylguanidine",102-06-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85a7482d-61f5-4625-b9b7-22bbafb256ee/documents/6a2ac65b-5301-4c10-8754-561d3f148ed0_90e60b99-7bbd-419e-abd3-7b4ce8742598.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Desmedipham,13684-56-5,"Studies of repeated dose oral toxicity in the rat, mouse and dog of duration up to 2 years are available for desmedipham.  The key study is identified as the 90-day rat study, as this identifies the lowest NOAEL (equivalent to 2.6-2.7 mg/kg bw/d). Test method/  species Result Assessment Reference Non-guideline  - 28-day dietary mouse study The NOAEL for this study is reported to be 100 ppm (22-26 mg/kg bw/d) based on haematological effects).  Supporting study Suter et al (1984) Non-guideline  - Non-guideline, 5-week dietary RF study performed with desmedipham (2000, 4000 ppm) Investigations in this study were very limited and are not sufficient to derive a NOAEL.  Notably there was no assessment of haematological parameters or histopathology This is a non-guideline and non-GLP range-finding study, which included very limited parameters. Mulhern and Perry (1989) Non-guideline  - 28-day dietary RF study in the dog Group size was very small (1/sex) and investigations were limited (no histopathology).  A NOAEL of 200 ppm (7 mg/kg bw/d) was determined for this study, based on haematological effects. This is a non-guideline range-finding study, which included very limited parameters. Bathe et al (1984) Non-guideline  - 6-week dietary RF study in the dog Group size was (3 males) and investigations were limited (no histopathology).  A NOAEL of 15 ppm (~0.5 mg/kg bw/d) was determined for this study, in the absence of any effects in any dose group. This is a non-guideline range-finding study, which included very limited parameters. Harling et al (1985) US EPA 82-1 - 90-day dietary study in the rat A NOAEL was not identified for this study due to haematological effects at the lowest tested concentration of 300 ppm (~24 mg/kg bw/d). Supporting study Suter et al (1984) US EPA 82-1 - 90-day dietary study in the rat A NOAEL of 30 ppm (2.6-2.7 mg/kg bw/d) was determined for this study, based on haematological effects at 60 ppm. Key study Suter et al (1985) Non-guideline  - 90-day dietary study in the rat A NOAEL of 160 ppm (10.6-12.3 mg/kg bw/d) was determined for this study, based on haematological effects at 800 ppm and higher. Supporting study Elliott et al (1987) Non-guideline  - 90-day dietary RF study in the mouse A NOAEL of 750 ppm (134-148 mg/kg bw/d) was determined for this study, based on haematological effects at 1300 ppm and higher. Supporting study Hill and Taupin (1992) Non-guideline  - 90-day dietary study in the dog A NOAEL of 150 ppm (5.24 mg/kg bw/d) can be determined for this study, based on marginal haematological effects at the highest dose level. Supporting study Hounsell and Martin (1986) Non-guideline  - 90-day dietary study in the dog A NOAEL of 100 ppm (4.1 mg/kg bw/d) can be determined for this study, based on thyroid effects (increased weight, follicular hypertrophy) in females. Supporting study Oshodi and MacNaughtan (1991) Non-guideline  - 80-day dietary mechanistic study in the dog, designed to identify a NOAEL for methaemoglobin formation A NOAEL was not identified for this study, due to splenic congestion (considered to be an effect secondary to MetHb formation) at the lowest dose level of 300 ppm. Supporting study Allen et al (1991) Non-guideline  - 12-month dietary toxicity study in the dog (considered to be chronic under REACH); broadly comparable to OECD 408 A NOAEL of 300 ppm (9.7-10.4 mg/kg bw/d) was agreed for this study, based on non-adverse findings (increased iron deposition in the liver, bone marrow and haematological parameters) at this dose level. Supporting study Bathe (1985) None stated - 52-week oral (dietary) chronic toxicity study in the rat performed at 0, 100, 400 and 1200 ppm A NOAEL of 100 ppm (6.5-8.0 mg/kg bw/d) was determined for this study, based on clinical chemistry changes at 400 ppm.  Haematological effects at 400 ppm were seen but were not considered to be adverse. Supporting study Everett et al (1991) US EPA 83-5 - Carcinogenicity study in the rat performed at 0, 100, 400 and 1200 ppm There was no evidence of carcinogenicity in this study.  A NOAEL of 100 ppm (5.4-5.9 mg/kg bw/d) was determined, based on haematological effects and histopathology (spleen, liver, kidneys) at 400 ppm Supporting study Everett et al (1991) Not stated, but comparable to OECD 453 - Carcinogenicity study in the rat performed at 0, 60, 300 and 1500 ppm There was no evidence of carcinogenicity in this study.  A NOAEL of 60 ppm (3.2 mg/kg bw/d) was determined based on minimal (and non-adverse) MetHb formation and increased spleen weight. Supporting study Suter et al (1986) OECD 451 - Carcinogenicity study in the mouse performed at 0, 400, 1000, 2500 ppm (report and amendment) There was no evidence of carcinogenicity in this study. A NOAEL of 400 ppm (72 mg/kg bw/d) was determined for females based on liver pathology.  A NOAEL could not be determined for males due to liver pathology ast 400 ppm (61 mg/kg bw/d). Supporting study Husband et al (1990) in IUCLID title;(add in data source) Not stated, but comparable to OECD 451 - Carcinogenicity study in the mouse performed at 0, 30, 150, 750 ppm There was no evidence of carcinogenicity in this study. A NOAEL of 150 ppm (22-31 mg/kg bw/d) was determined for this study, based on haematological effects. Supporting study Suter et al (1986) Not applicable - Additional pathology Additional histopathological and statistical evaluation performed for the rat study Suter et al (1986); can be reported with the original study. Not required - reassessment of study findings Not specified (2000) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Good quality oral repeated dose toxicity studies are available in the rat, mouse and dog. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a48e2f83-d904-475c-80f2-7db99c5013b2/documents/93d8eeab-016b-489d-99f2-3682e4cf054b_f26f026d-4bfc-4bb9-9ec4-ce08f74cda1d.html,,,,,, Desmedipham,13684-56-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a48e2f83-d904-475c-80f2-7db99c5013b2/documents/93d8eeab-016b-489d-99f2-3682e4cf054b_f26f026d-4bfc-4bb9-9ec4-ce08f74cda1d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,2.6 mg/kg bw/day,,rat Desmedipham,13684-56-5,"Acute oral toxicity The key rat study reports an acute oral LD50 for desmedipham of >2000 mg/kg bw.  A supporting mouse study reports an acute oral LD50 for desmedipham of >3500 mg/kg bw.  A supporting rat study reports an acute oral LD50 for desmedipham of >5000 mg/kg bw.  The studies show that desmedipham is not classified for acute oral toxicity in any category according to CLP. Test method/  species Result Assessment Reference Not stated (pre-guideline); comparable to OECD 401 -  No mortality or clinical signs reported in this mouse study at 5000 mg/kg bw The study is inadequately reported.  The test procedures, stability of the test material, raw data on body weights, clinical signs and necropsy findings were not included in the report. Schöbel and Siegmund (1975) OECD 401 (Limit Test) - Mouse study One mortality (0/5M, 1/5F) reported in this mouse study at 3500 mg/kg bw; clinical signs limited to the decedent mouse Supporting study Davies (1990) OECD 401 (Limit Test) - Rat study No mortality but some clinical signs reported in this rat study at 5000 mg/kg bw Supporting study Ullmann and Sacher (1984) OECD 401 (Limit Test) - Rat study No mortality or clinical signs reported in this rat study at 2000 mg/kg bw Key study Cuthbert and Jackson (1990) Acute inhalation toxicity The key rat study reports an acute (4-hour, nose-only) inhalation LC50 for desmedipham of >7.4 mg/L.  The study shows that desmedipham is not classified for acute inhalation toxicity in any category according to CLP. Test method/  species Result Assessment Reference Not specified. No animals were exposed due to technical difficulties in generating a test atmosphere The study is invalid due to technical difficulties in generating a suitable test atmosphere.  Consequently, no animals were exposed. McDonald (1991) OECD 403 - Rat study No deaths or clinical signs reported in rats exposed nose-only for four hours to atmospheres containing desmedipham at 5.7 or 7.4 mg/L (measured concentrations). Key study Thévenaz (1990) Acute dermal toxicity The key rat study reports an acute dermal LD50 for desmedipham of >2000 mg/kg bw.  The supporting rabbit study reports an acute dermal LD50 for desmedipham of >4000 mg/kg bw.  The studies show that desmedipham is not classified for acute dermal toxicity in any category according to CLP. Test method/  species Result Assessment Reference Not stated (pre-guideline); comparable to OECD 402 - Rabbit study: limited reliability (only 3/sex) No mortality or clinical signs reported in this rabbit study at 4000 mg/kg bw Supporting study Ullmann and Suter (1984) OECD 402 - Rat study No mortality or clinical signs reported in this rat study at 2000 mg/kg bw Key study Cuthbert and Jackson (1991) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The key rat study (K1) was performed to GLP and OECD 401. A supporting mouse study (K2) was performed to GLP and OECD 401. A supporting rat study (K2) was performed to OECD 401 but not GLP. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The key rat study (K2) was performed to GLP and OECD 403 with acceptable deviations. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The key rat study (K1) was performed to GLP and OECD 402. The supporting rabbit study (K2) was not performed to GLP or a recognised guideline, but was broadly comparable to OECD 402 with the exception of group size. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a48e2f83-d904-475c-80f2-7db99c5013b2/documents/7362cb38-cf3f-42a1-a5ba-ca0a2573acb4_f26f026d-4bfc-4bb9-9ec4-ce08f74cda1d.html,,,,,, Desmedipham,13684-56-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a48e2f83-d904-475c-80f2-7db99c5013b2/documents/7362cb38-cf3f-42a1-a5ba-ca0a2573acb4_f26f026d-4bfc-4bb9-9ec4-ce08f74cda1d.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Desmedipham,13684-56-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a48e2f83-d904-475c-80f2-7db99c5013b2/documents/7362cb38-cf3f-42a1-a5ba-ca0a2573acb4_f26f026d-4bfc-4bb9-9ec4-ce08f74cda1d.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Desmedipham,13684-56-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a48e2f83-d904-475c-80f2-7db99c5013b2/documents/7362cb38-cf3f-42a1-a5ba-ca0a2573acb4_f26f026d-4bfc-4bb9-9ec4-ce08f74cda1d.html,,inhalation,LC50,> 7.4 mg/L,no adverse effect observed, "2,4,6,8-tetramethyl-1,3,5,7-tetraoxacyclooctane",108-62-3," A study was performed to determine the acute oral median lethal dose (LD50 ) of the test material, administered as a suspension in arachis oil in the Sprague-Dawley CFY strain rat. The method used followed that described in the OECO No. 401. Following a range-finding study, four groups, each of ten fasted animals (five males and five females), were given a single oral dose of test material preparation at dose levels of 100 to 800 mg/kg body weight. Two males treated with 800 mg/kg and one male treated with 400 mg/kg were found dead immediately after dosing. All other deaths were noted six or twelve hours after dosing. Principal signs of toxicity noted in both decedents and surviving animals were hunched posture, pilo-erection, lethargy and decreased respiratory rate. Occasional or isolated signs of increased salivation, ptosis, body tremors or occasional body tremors, red/brown staining around the eyes, snout and mouth with diuresis, diarrhoea, tonic convulsions, ataxia and coma. Signs of toxicity were first noted immediately after dosing. Surviving animals were normal two to eight days after dosing. All surviving animals showed expected gains in bodyweight over the study period. Common abnormalities noted in decedents were abnormally red or haemorrhaged lungs, dark or patchy pallor of the liver, with congestion of the small intestines. Sloughing of the gastric mucosa was also noted. In conclusion, the acute oral LD 50 was found to be 283 mg/kg (males/females). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0e268f4-feea-4995-8530-394fb5242a09/documents/8ff05fdf-d39f-45d8-90ff-cf9ada16cfdf_bcf6a4e1-a114-439a-9517-d0cc3dc97621.html,,,,,, "2,4,6,8-tetramethyl-1,3,5,7-tetraoxacyclooctane",108-62-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0e268f4-feea-4995-8530-394fb5242a09/documents/8ff05fdf-d39f-45d8-90ff-cf9ada16cfdf_bcf6a4e1-a114-439a-9517-d0cc3dc97621.html,,oral,LD50,283 mg/kg bw,adverse effect observed, "Aromatic hydrocarbons, C7-12, C8-rich",93571-75-6,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a398c006-4942-4262-bce9-e96992df34d6/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_d7e9b407-bb83-4303-86d6-9e644cd5ec65.html,,,,,, "Aromatic hydrocarbons, C7-12, C8-rich",93571-75-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a398c006-4942-4262-bce9-e96992df34d6/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_d7e9b407-bb83-4303-86d6-9e644cd5ec65.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Aromatic hydrocarbons, C7-12, C8-rich",93571-75-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a398c006-4942-4262-bce9-e96992df34d6/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_d7e9b407-bb83-4303-86d6-9e644cd5ec65.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Aromatic hydrocarbons, C7-12, C8-rich",93571-75-6," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a398c006-4942-4262-bce9-e96992df34d6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_d7e9b407-bb83-4303-86d6-9e644cd5ec65.html,,,,,, "Aromatic hydrocarbons, C7-12, C8-rich",93571-75-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a398c006-4942-4262-bce9-e96992df34d6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_d7e9b407-bb83-4303-86d6-9e644cd5ec65.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Aromatic hydrocarbons, C7-12, C8-rich",93571-75-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a398c006-4942-4262-bce9-e96992df34d6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_d7e9b407-bb83-4303-86d6-9e644cd5ec65.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aromatic hydrocarbons, C7-12, C8-rich",93571-75-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a398c006-4942-4262-bce9-e96992df34d6/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_d7e9b407-bb83-4303-86d6-9e644cd5ec65.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Clarified oils (petroleum), catalytic cracked",64741-62-4," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a345aaca-6a3a-4407-b411-bd5d23bf7a59/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_a4e37a7e-e07c-40b2-bc85-2aee212fe9da.html,,,,,, "Clarified oils (petroleum), catalytic cracked",64741-62-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a345aaca-6a3a-4407-b411-bd5d23bf7a59/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_a4e37a7e-e07c-40b2-bc85-2aee212fe9da.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Clarified oils (petroleum), catalytic cracked",64741-62-4,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a345aaca-6a3a-4407-b411-bd5d23bf7a59/documents/12190120-6b6e-49c5-bed7-264eab246437_a4e37a7e-e07c-40b2-bc85-2aee212fe9da.html,,,,,, "Clarified oils (petroleum), catalytic cracked",64741-62-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a345aaca-6a3a-4407-b411-bd5d23bf7a59/documents/12190120-6b6e-49c5-bed7-264eab246437_a4e37a7e-e07c-40b2-bc85-2aee212fe9da.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Clarified oils (petroleum), catalytic cracked",64741-62-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a345aaca-6a3a-4407-b411-bd5d23bf7a59/documents/12190120-6b6e-49c5-bed7-264eab246437_a4e37a7e-e07c-40b2-bc85-2aee212fe9da.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Clarified oils (petroleum), catalytic cracked",64741-62-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a345aaca-6a3a-4407-b411-bd5d23bf7a59/documents/12190120-6b6e-49c5-bed7-264eab246437_a4e37a7e-e07c-40b2-bc85-2aee212fe9da.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "Creosote oil, acenaphthene fraction",90640-84-9,No experimental data is available on wash oil itself. Results from key components as well as from a structure-related tar oil are used to draw conclusions by analogy. ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d3c6332-760f-4a03-8837-4e6b0c4020ef/documents/IUC5-842fe8ec-d322-446e-853e-3eb167df2741_96c38e60-99fc-4f2d-8c46-b03085053faf.html,,,,,, "Creosote oil, acenaphthene fraction",90640-84-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d3c6332-760f-4a03-8837-4e6b0c4020ef/documents/IUC5-842fe8ec-d322-446e-853e-3eb167df2741_96c38e60-99fc-4f2d-8c46-b03085053faf.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,22 mg/m3,,rat "Creosote oil, acenaphthene fraction",90640-84-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d3c6332-760f-4a03-8837-4e6b0c4020ef/documents/IUC5-842fe8ec-d322-446e-853e-3eb167df2741_96c38e60-99fc-4f2d-8c46-b03085053faf.html,Chronic toxicity – systemic effects,oral,BMD05,4.7 mg/kg bw/day,,mouse "Creosote oil, acenaphthene fraction",90640-84-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d3c6332-760f-4a03-8837-4e6b0c4020ef/documents/IUC5-842fe8ec-d322-446e-853e-3eb167df2741_96c38e60-99fc-4f2d-8c46-b03085053faf.html,Chronic toxicity – systemic effects,dermal,LOAEL,34 mg/kg bw/day,,mouse "Creosote oil, acenaphthene fraction",90640-84-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d3c6332-760f-4a03-8837-4e6b0c4020ef/documents/IUC5-842fe8ec-d322-446e-853e-3eb167df2741_96c38e60-99fc-4f2d-8c46-b03085053faf.html,Repeated dose toxicity – local effects,inhalation,NOAEC,22 mg/m3,adverse effect observed,rat "Creosote oil, acenaphthene fraction",90640-84-9,"No acute toxicity after single oral, dermal and inhalational administration to rats, based on experimental data on wash oil itself, single components, and structure-analogous compounds. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d3c6332-760f-4a03-8837-4e6b0c4020ef/documents/IUC5-293b1a91-b777-4859-9818-c4f6de869f04_96c38e60-99fc-4f2d-8c46-b03085053faf.html,,,,,, "Creosote oil, acenaphthene fraction",90640-84-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d3c6332-760f-4a03-8837-4e6b0c4020ef/documents/IUC5-293b1a91-b777-4859-9818-c4f6de869f04_96c38e60-99fc-4f2d-8c46-b03085053faf.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Creosote oil, acenaphthene fraction",90640-84-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d3c6332-760f-4a03-8837-4e6b0c4020ef/documents/IUC5-293b1a91-b777-4859-9818-c4f6de869f04_96c38e60-99fc-4f2d-8c46-b03085053faf.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), catalytic reformed hydrotreated light, C8-12 arom. fraction",85116-58-1,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c487e5b-4a51-4473-b038-827bba052d3a/documents/IUC5-70ab9395-86d5-44ad-abdd-8edfe6380aeb_190f1966-be6c-4604-8d4f-06ce988ebb71.html,,,,,, "Distillates (petroleum), catalytic reformed hydrotreated light, C8-12 arom. fraction",85116-58-1,Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401)Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions)Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c487e5b-4a51-4473-b038-827bba052d3a/documents/IUC5-7b2210ac-d7ab-4596-b9f0-711bf0f0a306_190f1966-be6c-4604-8d4f-06ce988ebb71.html,,,,,, "Distillates (petroleum), light straight-run gasoline fractionation stabilizer overheads",68921-08-4,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2aee9ac4-11c6-443c-8651-38ccf5337a07/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_49187a6c-6ff2-41d4-8b3d-f4aa5ce3a94f.html,,,,,, "Distillates (petroleum), light straight-run gasoline fractionation stabilizer overheads",68921-08-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2aee9ac4-11c6-443c-8651-38ccf5337a07/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_49187a6c-6ff2-41d4-8b3d-f4aa5ce3a94f.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Distillates (petroleum), light straight-run gasoline fractionation stabilizer overheads",68921-08-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2aee9ac4-11c6-443c-8651-38ccf5337a07/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_49187a6c-6ff2-41d4-8b3d-f4aa5ce3a94f.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Distillates (petroleum), light straight-run gasoline fractionation stabilizer overheads",68921-08-4," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2aee9ac4-11c6-443c-8651-38ccf5337a07/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_49187a6c-6ff2-41d4-8b3d-f4aa5ce3a94f.html,,,,,, "Distillates (petroleum), light straight-run gasoline fractionation stabilizer overheads",68921-08-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2aee9ac4-11c6-443c-8651-38ccf5337a07/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_49187a6c-6ff2-41d4-8b3d-f4aa5ce3a94f.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light straight-run gasoline fractionation stabilizer overheads",68921-08-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2aee9ac4-11c6-443c-8651-38ccf5337a07/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_49187a6c-6ff2-41d4-8b3d-f4aa5ce3a94f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light straight-run gasoline fractionation stabilizer overheads",68921-08-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2aee9ac4-11c6-443c-8651-38ccf5337a07/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_49187a6c-6ff2-41d4-8b3d-f4aa5ce3a94f.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, Tetrafluoroethylene,116-14-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/977aa5d3-07ce-4674-a545-197844ff38c6/documents/IUC5-6b9cdff1-86c2-42c5-ac66-e5d7f7db45d5_e90c14e4-f1d0-44b3-9560-8e68e49b9e00.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,638 mg/m3,, Tetrafluoroethylene,116-14-3,"The reported acute LC50 values are relatively consistent and show no particular sex- or species related sensitivity. The 4 hr LC50 can be estimated to be about 30000ppm (123000 mg/m3) in the rat, although no Reliability 2 study report is available. A Reliability 2 study is available in the hamster, which reported a 4 hr LC50 value of 28500 ppm (116508 mg/m3). The primary toxic effect is kidney damage (proximal tubule necrosis) observed in the rat at concentrations around 3700 ppm (15100 mg/m3) for 4 hours in absence of any clinincal sign of toxicity. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/977aa5d3-07ce-4674-a545-197844ff38c6/documents/IUC5-5fcb46f6-a84f-4d20-8325-923e4c8147a8_e90c14e4-f1d0-44b3-9560-8e68e49b9e00.html,,,,,, Tetrafluoroethylene,116-14-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/977aa5d3-07ce-4674-a545-197844ff38c6/documents/IUC5-5fcb46f6-a84f-4d20-8325-923e4c8147a8_e90c14e4-f1d0-44b3-9560-8e68e49b9e00.html,,inhalation,LC50,"116,508 mg/m3",, (RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate,1101132-67-5,"oral: The NOAELs of the test item in mice were determined to be 500 ppm for males (70.8 mg/kg bw/day) and 2000 ppm for females (331 mg/kg bw/day), respectively, after 13 weeks administration via diet. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5f55233a-0c73-42ef-9c88-d77338e76540/documents/88233ad4-9fc7-4bf4-a1ea-e0103bf35e38_49708500-49d2-4f20-ad49-beba03e359bd.html,,,,,, (RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate,1101132-67-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5f55233a-0c73-42ef-9c88-d77338e76540/documents/88233ad4-9fc7-4bf4-a1ea-e0103bf35e38_49708500-49d2-4f20-ad49-beba03e359bd.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,300 mg/kg bw/day,,rat (RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate,1101132-67-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5f55233a-0c73-42ef-9c88-d77338e76540/documents/88233ad4-9fc7-4bf4-a1ea-e0103bf35e38_49708500-49d2-4f20-ad49-beba03e359bd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,70.8 mg/kg bw/day,,mouse (RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate,1101132-67-5,oral: The acute oral LD50 of the test item can be concluded to be > 2000 mg/kg bw in the rat. inhalative: The LC50 was concluded to be >2.01 mg/L. dermal: The acute dermal LD50 of the test item was found to be > 2000 mg/kg bw. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f55233a-0c73-42ef-9c88-d77338e76540/documents/8ca9458b-4c01-40ee-beb9-e92b79a7a248_49708500-49d2-4f20-ad49-beba03e359bd.html,,,,,, (RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate,1101132-67-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f55233a-0c73-42ef-9c88-d77338e76540/documents/8ca9458b-4c01-40ee-beb9-e92b79a7a248_49708500-49d2-4f20-ad49-beba03e359bd.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, (RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate,1101132-67-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f55233a-0c73-42ef-9c88-d77338e76540/documents/8ca9458b-4c01-40ee-beb9-e92b79a7a248_49708500-49d2-4f20-ad49-beba03e359bd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, (RS)-1-{1-ethyl-4-[4-mesyl-3-(2-methoxyethoxy)-o-toluoyl]pyrazol-5-yloxy}ethyl methyl carbonate; tolpyralate,1101132-67-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f55233a-0c73-42ef-9c88-d77338e76540/documents/8ca9458b-4c01-40ee-beb9-e92b79a7a248_49708500-49d2-4f20-ad49-beba03e359bd.html,,inhalation,LC50,> 2.01 mg/L,no adverse effect observed, "Fuel oil, heavy, high-sulfur",92045-14-2," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c3bdd3d-3c68-413d-b1ed-eb774f726524/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_4e25cf82-afb4-421f-be7b-01955fff300c.html,,,,,, "Fuel oil, heavy, high-sulfur",92045-14-2,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c3bdd3d-3c68-413d-b1ed-eb774f726524/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_4e25cf82-afb4-421f-be7b-01955fff300c.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Fuel oil, heavy, high-sulfur",92045-14-2,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c3bdd3d-3c68-413d-b1ed-eb774f726524/documents/12190120-6b6e-49c5-bed7-264eab246437_4e25cf82-afb4-421f-be7b-01955fff300c.html,,,,,, "Fuel oil, heavy, high-sulfur",92045-14-2,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c3bdd3d-3c68-413d-b1ed-eb774f726524/documents/12190120-6b6e-49c5-bed7-264eab246437_4e25cf82-afb4-421f-be7b-01955fff300c.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Fuel oil, heavy, high-sulfur",92045-14-2,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c3bdd3d-3c68-413d-b1ed-eb774f726524/documents/12190120-6b6e-49c5-bed7-264eab246437_4e25cf82-afb4-421f-be7b-01955fff300c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fuel oil, heavy, high-sulfur",92045-14-2,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c3bdd3d-3c68-413d-b1ed-eb774f726524/documents/12190120-6b6e-49c5-bed7-264eab246437_4e25cf82-afb4-421f-be7b-01955fff300c.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "dimethomorph (ISO); 4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine",110488-70-5,"Oral: Subchronic, rat: NOAEL = 12.7 mg/kg bw/d (90d, OECD 408, GLP) Chronic, dog: NOEAL = 4.9 mg/kg bw/d (52-wk, OECD 409, GLP) Chronic, rat: NOEAL = 9.4 mg/kg bw/d (104-wk, similar to OECD 452, GLP)   Dermal: Subacute, dermal, rat: NOEAL = 1000 mg/kg bw/d (28d, OECD 410, GLP)   Inhalation: No data available. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65b81ef7-96c0-4be8-9c39-3b066eba01db/documents/12375bb9-337c-41d3-97f0-7eb5eb3f0a48_65fd663f-d1ed-46c6-b149-9db1ae996d26.html,,,,,, "dimethomorph (ISO); 4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine",110488-70-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65b81ef7-96c0-4be8-9c39-3b066eba01db/documents/12375bb9-337c-41d3-97f0-7eb5eb3f0a48_65fd663f-d1ed-46c6-b149-9db1ae996d26.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,81 mg/kg bw/day,,rat "dimethomorph (ISO); 4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine",110488-70-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65b81ef7-96c0-4be8-9c39-3b066eba01db/documents/12375bb9-337c-41d3-97f0-7eb5eb3f0a48_65fd663f-d1ed-46c6-b149-9db1ae996d26.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "dimethomorph (ISO); 4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine",110488-70-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65b81ef7-96c0-4be8-9c39-3b066eba01db/documents/12375bb9-337c-41d3-97f0-7eb5eb3f0a48_65fd663f-d1ed-46c6-b149-9db1ae996d26.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,12.7 mg/kg bw/day,,rat "dimethomorph (ISO); 4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine",110488-70-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65b81ef7-96c0-4be8-9c39-3b066eba01db/documents/12375bb9-337c-41d3-97f0-7eb5eb3f0a48_65fd663f-d1ed-46c6-b149-9db1ae996d26.html,Chronic toxicity – systemic effects,oral,NOAEL,4.9 mg/kg bw/day,,dog "dimethomorph (ISO); 4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine",110488-70-5,"oral: LD50 ≥ 2000 mg/kg bw (rat, OECD 401, GLP) dermal: LD50 > 2000 mg/kg bw (rat, OECD 402, GLP) inhalation: LC50 > 5.2 mg/L (rat, 4h, dust OECD 403, GLP) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65b81ef7-96c0-4be8-9c39-3b066eba01db/documents/6b3c9fad-a4a7-4c08-be12-5c72a4a1d360_65fd663f-d1ed-46c6-b149-9db1ae996d26.html,,,,,, "dimethomorph (ISO); 4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine",110488-70-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65b81ef7-96c0-4be8-9c39-3b066eba01db/documents/6b3c9fad-a4a7-4c08-be12-5c72a4a1d360_65fd663f-d1ed-46c6-b149-9db1ae996d26.html,,oral,LD50,">=2,000 mg/kg bw",no adverse effect observed, "dimethomorph (ISO); 4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine",110488-70-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65b81ef7-96c0-4be8-9c39-3b066eba01db/documents/6b3c9fad-a4a7-4c08-be12-5c72a4a1d360_65fd663f-d1ed-46c6-b149-9db1ae996d26.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "dimethomorph (ISO); 4-(3-(4-chlorophenyl)-3-(3,4-dimethoxyphenyl)acryloyl)morpholine",110488-70-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65b81ef7-96c0-4be8-9c39-3b066eba01db/documents/6b3c9fad-a4a7-4c08-be12-5c72a4a1d360_65fd663f-d1ed-46c6-b149-9db1ae996d26.html,,inhalation,LC50,"5,200 mg/m3",no adverse effect observed, Bis(2-(2-methoxyethoxy)ethyl) ether,143-24-8,"Oral: NOAEL (28 days, gavage; rat): 250 mg/kg bwMain target organ: testes, thymus, hematopoetic system Oral (read across to triglyme):NOAEL (28 days, gavage; rat): 250 mg/kg bwMain target organ: testes, thymus, hematopoetic systemBy inhalation (read across to diglyme):NOAEL (14 days; rat): 110 ppm (650 mg/kg bw)Main target organ: testes, thymus, hematopoetic system ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12418b84-e468-4729-b7de-26fa6b3ee8b5/documents/IUC5-23c4dbdf-f71d-4b59-a32b-ed30474377c9_6228d129-16ae-428f-9997-ba0205b02ba0.html,,,,,, Bis(2-(2-methoxyethoxy)ethyl) ether,143-24-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12418b84-e468-4729-b7de-26fa6b3ee8b5/documents/IUC5-23c4dbdf-f71d-4b59-a32b-ed30474377c9_6228d129-16ae-428f-9997-ba0205b02ba0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Bis(2-(2-methoxyethoxy)ethyl) ether,143-24-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12418b84-e468-4729-b7de-26fa6b3ee8b5/documents/IUC5-23c4dbdf-f71d-4b59-a32b-ed30474377c9_6228d129-16ae-428f-9997-ba0205b02ba0.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,650 mg/m3,,rat Bis(2-(2-methoxyethoxy)ethyl) ether,143-24-8,"Oral:- female rats, LD50: 3850 mg/kg bw- female mice, LD50: 5140 mg/kg bw (supporting data)- female rats, LD50 (triglyme): 5390 mg/kg bw (supporting data)- female rats, LD50 (diglyme): 4760 mg/kg bw (supporting data)- female rats, LD50 (monoglyme): 5370 mg/kg bw (supporting data)- male rats, LD50 (2-ME): 2460 mg/kg bw (supporting data)- rats, LD50 (EMDE): ca.6500 mg/kg bw (supporting data)Inhalation:- male/female rats, LC0 (diglyme; 7h exposure): 11 mg/L -> 19.3 mg/L (4h calculated exposure)- male/female rats, LC0 (monoglyme; 1h exposure): 240 mg/L -> 60 mg/L (4h calculated exposure)- rats, LC50 (monoglymer; 6h exposure): > 20 mg/LDermal:- male rats, LD50 (triglyme): > 6900 mg/kg bw ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12418b84-e468-4729-b7de-26fa6b3ee8b5/documents/IUC5-bde10ef6-984d-4dd9-8a6f-1d6e120a6d0d_6228d129-16ae-428f-9997-ba0205b02ba0.html,,,,,, Bis(2-(2-methoxyethoxy)ethyl) ether,143-24-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12418b84-e468-4729-b7de-26fa6b3ee8b5/documents/IUC5-bde10ef6-984d-4dd9-8a6f-1d6e120a6d0d_6228d129-16ae-428f-9997-ba0205b02ba0.html,,oral,LD50,"3,850 mg/kg bw",no adverse effect observed, Tris(2-methoxyethoxy)vinylsilane,1067-53-4," In a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test, conducted according to OECD Test Guideline 422 study and in compliance with GLP, tris(2-methoxyethoxy)vinylsilane was tested in rats by oral gavage. A NOAEL for male toxicity was concluded to be 25 mg/kg bw/day based on decreased body weights, body weight gains and food consumption, effects on haematology and serum chemistry parameters as macroscopic and microscopic changes in male rats reproductive organs and tissues at 75 and 250 mg/kg bw/day. A NOAEL for females was concluded to be 75 mg/kg bw/day based on effects on haematology and serum chemistry parameters and effects on lymphoid tissues (WIL Research Laboratories, 2005). ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/653aeb36-5f83-4439-8d1b-659c812f743a/documents/975268f2-19da-448d-b30d-44f93a08ee76_98c578d2-4c87-4916-b4f5-4998106cf534.html,,,,,, Tris(2-methoxyethoxy)vinylsilane,1067-53-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/653aeb36-5f83-4439-8d1b-659c812f743a/documents/975268f2-19da-448d-b30d-44f93a08ee76_98c578d2-4c87-4916-b4f5-4998106cf534.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Tris(2-methoxyethoxy)vinylsilane,1067-53-4," In the key acute oral toxicity study (WIL Research Laboratories, 1999a), conducted according to OECD Test Guideline 401 and in compliance with GLP, the LD50 for rats was determined to be =2000 mg/kg bw.  In the key acute dermal toxicity study (WIL Research Laboratories, 1999b), conducted according to OECD Test Guideline 402 and in compliance with GLP, the LD50 for rats was determined to be =2000 mg/kg bw. There were no clinical signs or abnormalities at necropsy although, local desquamation was observed. In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5.2) does not need to be conducted as reliable data via the oral and dermal routes are available. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/653aeb36-5f83-4439-8d1b-659c812f743a/documents/3197913c-2ca7-4579-b1ff-c17f51677853_98c578d2-4c87-4916-b4f5-4998106cf534.html,,,,,, Tris(2-methoxyethoxy)vinylsilane,1067-53-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/653aeb36-5f83-4439-8d1b-659c812f743a/documents/3197913c-2ca7-4579-b1ff-c17f51677853_98c578d2-4c87-4916-b4f5-4998106cf534.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tris(2-methoxyethoxy)vinylsilane,1067-53-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/653aeb36-5f83-4439-8d1b-659c812f743a/documents/3197913c-2ca7-4579-b1ff-c17f51677853_98c578d2-4c87-4916-b4f5-4998106cf534.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), full-range alkylate",64741-64-6,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c296c37-7c42-4638-8de7-a1f018a751a8/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_0314c826-e506-4a69-9fe7-26be942640a6.html,,,,,, "Naphtha (petroleum), full-range alkylate",64741-64-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c296c37-7c42-4638-8de7-a1f018a751a8/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_0314c826-e506-4a69-9fe7-26be942640a6.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), full-range alkylate",64741-64-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c296c37-7c42-4638-8de7-a1f018a751a8/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_0314c826-e506-4a69-9fe7-26be942640a6.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), full-range alkylate",64741-64-6," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c296c37-7c42-4638-8de7-a1f018a751a8/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_0314c826-e506-4a69-9fe7-26be942640a6.html,,,,,, "Naphtha (petroleum), full-range alkylate",64741-64-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c296c37-7c42-4638-8de7-a1f018a751a8/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_0314c826-e506-4a69-9fe7-26be942640a6.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), full-range alkylate",64741-64-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c296c37-7c42-4638-8de7-a1f018a751a8/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_0314c826-e506-4a69-9fe7-26be942640a6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), full-range alkylate",64741-64-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c296c37-7c42-4638-8de7-a1f018a751a8/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_0314c826-e506-4a69-9fe7-26be942640a6.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, Thiophanate-methyl,23564-05-8," Repeated dose oral: A study according EPA OPP 83-5 (GLP) and similar to OECD TG 453 is available. In males and females rats at dose levels of 1200 or 6000 ppm treatment-related effects were seen which included body weight depression, anemia, accelerated nephropathy, adrenal cortical lipidosis, hepatocellular hypertrophy with an associated increase in serum cholesterol and total protein, decreased T3/T4, increased TSH, and thyroid follicular hyperplasia. A treatment-related increase in organ weights of liver, thyroid and kidneys also occurred. Based upon body weight depression and mortality, the MTD was determined to be 1200 ppm for both sexes. At 6000 ppm, approximately 5 times the MTD, an increase in thyroid follicular cell adenomas was observed in the males. These adenomas were considered to be a secondary effect, related to the treatment-related changes in hormonal homeostasis of the pituitary-thyroid axis. The NOAEL was 200 ppm (8.8 and 10.2 mg/kg bw/day in male and female rats, respectively). Repeated dose dermal: A study according to EPA 82-2 and similar to OECD TG 410 was conducted. New-Zealand White rabbits were treated with the substance at doses of 100, 300 and 1000 mg/kg bw/day. The NOAEL is considered to be 1000 mg/kg bw/day under the conditions of this study. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b319bb7-e477-4a73-a05c-cbd4ab61708d/documents/08f634e1-4f66-4a1f-a5aa-a915a0389506_75f56ecb-22de-417f-97aa-41e93297e2aa.html,,,,,, Thiophanate-methyl,23564-05-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b319bb7-e477-4a73-a05c-cbd4ab61708d/documents/08f634e1-4f66-4a1f-a5aa-a915a0389506_75f56ecb-22de-417f-97aa-41e93297e2aa.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rabbit Thiophanate-methyl,23564-05-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b319bb7-e477-4a73-a05c-cbd4ab61708d/documents/08f634e1-4f66-4a1f-a5aa-a915a0389506_75f56ecb-22de-417f-97aa-41e93297e2aa.html,Chronic toxicity – systemic effects,oral,NOAEL,8.8 mg/kg bw/day,,rat Thiophanate-methyl,23564-05-8, In the acute oral toxicity study no adverse effects have been observed and a discriminating dose > 5000 mg/kg bw was determined for rats. The substance was tested for inhalation toxicity in rats in a 4 h whole-body inhalation study similar to OECD TG 403. The acute inhalation median lethal concentration (4hr LC50) was determined to be 1700 mg/m3 for males and 1900 mg/m3 for females. The acute dermal LD50 was determined to be > 2000 mg/kg bw. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b319bb7-e477-4a73-a05c-cbd4ab61708d/documents/a8313b7b-6dab-4e36-a674-afb2a020b264_75f56ecb-22de-417f-97aa-41e93297e2aa.html,,,,,, Thiophanate-methyl,23564-05-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b319bb7-e477-4a73-a05c-cbd4ab61708d/documents/a8313b7b-6dab-4e36-a674-afb2a020b264_75f56ecb-22de-417f-97aa-41e93297e2aa.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Thiophanate-methyl,23564-05-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b319bb7-e477-4a73-a05c-cbd4ab61708d/documents/a8313b7b-6dab-4e36-a674-afb2a020b264_75f56ecb-22de-417f-97aa-41e93297e2aa.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Thiophanate-methyl,23564-05-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b319bb7-e477-4a73-a05c-cbd4ab61708d/documents/a8313b7b-6dab-4e36-a674-afb2a020b264_75f56ecb-22de-417f-97aa-41e93297e2aa.html,,inhalation,LC50,"1,700 mg/m3",adverse effect observed, "Residual oils (petroleum), catalytic dewaxed",91770-57-9,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEL (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils. A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study that tested distillate aromatic extracts. Sufficiently refined other lubricant baseoils are not classified according to DSD for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd4404fa-2814-4020-85fc-9f65c5101466/documents/IUC5-748bb69d-ce48-462f-89ca-bdf2ce955fad_d8ab2395-7f82-41e8-b5a1-f3a8359c8bc0.html,,,,,, "Residual oils (petroleum), catalytic dewaxed",91770-57-9,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. The acute inhalation LC50 for other lubricant base oils is >5.0 mg/L. ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd4404fa-2814-4020-85fc-9f65c5101466/documents/IUC5-69a65843-7186-4761-8d35-387911c0bc26_d8ab2395-7f82-41e8-b5a1-f3a8359c8bc0.html,,,,,, "Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based",72623-86-0,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e506f21d-4590-4333-ab4c-ae6a737c6104/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_c033a311-a662-46b3-85aa-2a97ea79e2db.html,,,,,, "Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based",72623-86-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e506f21d-4590-4333-ab4c-ae6a737c6104/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_c033a311-a662-46b3-85aa-2a97ea79e2db.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based",72623-86-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e506f21d-4590-4333-ab4c-ae6a737c6104/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_c033a311-a662-46b3-85aa-2a97ea79e2db.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based",72623-86-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e506f21d-4590-4333-ab4c-ae6a737c6104/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_c033a311-a662-46b3-85aa-2a97ea79e2db.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based",72623-86-0,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e506f21d-4590-4333-ab4c-ae6a737c6104/documents/73761dae-46d6-428e-8e40-e5cc70088d96_c033a311-a662-46b3-85aa-2a97ea79e2db.html,,,,,, "Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based",72623-86-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e506f21d-4590-4333-ab4c-ae6a737c6104/documents/73761dae-46d6-428e-8e40-e5cc70088d96_c033a311-a662-46b3-85aa-2a97ea79e2db.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based",72623-86-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e506f21d-4590-4333-ab4c-ae6a737c6104/documents/73761dae-46d6-428e-8e40-e5cc70088d96_c033a311-a662-46b3-85aa-2a97ea79e2db.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Lubricating oils (petroleum), C15-30, hydrotreated neutral oil-based",72623-86-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e506f21d-4590-4333-ab4c-ae6a737c6104/documents/73761dae-46d6-428e-8e40-e5cc70088d96_c033a311-a662-46b3-85aa-2a97ea79e2db.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Distillates (petroleum), heavy naphthenic",64741-53-3,"In a read-across 90-day oral study (equivalent to OECD 408) from distillate aromatic extract, a NOAEL could not be identified and is less than 125 mg/kg/day to male rats. In a read-across subacute inhalation study (non-guideline) from other lubricant base oils (IP 346 < 3%), the NOAEC for pulmonary effects was 500 mg/m3, and the NOAEC for systemic effects resulting from inhalation exposure was =1500 mg/m3 in rats. One key 28-day dermal study (OECD 410) was identified, along with one read-across 90-day dermal study (OECD 411) from distillate aromatic extract. For the 28-day dermal study, the systemic NOAEL in this study is 1000 mg/kg/day for rabbits dosed with 0, 200, 1000, or 2000 mg/kg/day. The dermal NOAEL is <200 mg/kg/day based on the irritation at the treatment site. For the 90-day dermal read-across study conducted with rats at dose levels of 30, 125, 500, or 1250 mg/kg/day, the LOAEL is 30 mg/kg/day, based on body weight, clinical chemistry, organ weights, gross pathology, and histopathology. A NOAEL is not identified. ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/213d08a2-3cdc-41c1-a169-a8eba5cabe4a/documents/IUC5-a814c02a-c517-4c10-b49b-f3436f9e5f7e_4be11def-5066-4224-9eeb-34eff01b3a5e.html,,,,,, "Distillates (petroleum), heavy naphthenic",64741-53-3,Key acute oral (OECD 401) and dermal (OECD 402) studies were identified for unrefined acid treated oils. A read-across acute toxicity for inhalation (OECD 403) was identified from distillate aromatic extracts. LD50 and LC50 values were as follows:• The oral LD50 was > 5000 mg/kg bw in male and female rats exposed to unrefined/acid treated oils.• The dermal LD50 was > 2000 mg/kg bw in male and female rabbits exposed to unrefined/acid treated oils.• The LC50 was >5 mg/L (equivalent to 5000 mg/m3) in male and female rats exposed to distillate aromatic extracts. ,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/213d08a2-3cdc-41c1-a169-a8eba5cabe4a/documents/IUC5-84b68e58-345b-49ea-ab24-424d7304bb51_4be11def-5066-4224-9eeb-34eff01b3a5e.html,,,,,, "Distillates (petroleum), heavy naphthenic",64741-53-3,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/213d08a2-3cdc-41c1-a169-a8eba5cabe4a/documents/IUC5-84b68e58-345b-49ea-ab24-424d7304bb51_4be11def-5066-4224-9eeb-34eff01b3a5e.html,,oral,LD50,"5,000 mg/kg bw",, "Distillates (petroleum), heavy naphthenic",64741-53-3,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/213d08a2-3cdc-41c1-a169-a8eba5cabe4a/documents/IUC5-84b68e58-345b-49ea-ab24-424d7304bb51_4be11def-5066-4224-9eeb-34eff01b3a5e.html,,dermal,LD50,"2,000 mg/kg bw",, "Distillates (petroleum), heavy naphthenic",64741-53-3,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/213d08a2-3cdc-41c1-a169-a8eba5cabe4a/documents/IUC5-84b68e58-345b-49ea-ab24-424d7304bb51_4be11def-5066-4224-9eeb-34eff01b3a5e.html,,inhalation,LC50,"5,000 mg/m3",, Acetamide,60-35-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): One reliable study is available. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d873d621-aa44-4ffd-a891-9efaf95b2e1d/documents/IUC5-f11042cd-0123-49fc-8f17-92c6654ad15a_2076ddbb-e297-43f8-9521-cafa68b07e77.html,,,,,, Acetamide,60-35-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d873d621-aa44-4ffd-a891-9efaf95b2e1d/documents/IUC5-f11042cd-0123-49fc-8f17-92c6654ad15a_2076ddbb-e297-43f8-9521-cafa68b07e77.html,,oral,LD50,"12,900 mg/kg bw",no adverse effect observed, "Petroleum gases, liquefied, sweetened, C4 fraction",92045-80-2," Only one stream (Liquified Petroleum Gases CAS 68476 -85 -7) of the Other Petroleum Gases category has been tested but this and the main constituents of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and humans. The mammalian toxicity effects of this category will be driven by the content of benzene if the latter is present at levels of >10%. Additionally, the category may contain carbon monoxide which could trigger classification. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4d4e47d-14d1-478e-ae10-3f95ec580073/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_10bb6471-6c82-47f8-913d-aa75b19c1f2c.html,,,,,, "Petroleum gases, liquefied, sweetened, C4 fraction",92045-80-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4d4e47d-14d1-478e-ae10-3f95ec580073/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_10bb6471-6c82-47f8-913d-aa75b19c1f2c.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"7,214 mg/m3",,rat "Petroleum gases, liquefied, sweetened, C4 fraction",92045-80-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4d4e47d-14d1-478e-ae10-3f95ec580073/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_10bb6471-6c82-47f8-913d-aa75b19c1f2c.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"8,600 mg/m3",adverse effect observed,rat "Petroleum gases, liquefied, sweetened, C4 fraction",92045-80-2," Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the constituents. Across species, main constituent gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene in streams where it is present at levels of <1%. However, some streams in this category may contain benzene levels >1% or carbon monoxide which could trigger classification. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4d4e47d-14d1-478e-ae10-3f95ec580073/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_10bb6471-6c82-47f8-913d-aa75b19c1f2c.html,,,,,, "Petroleum gases, liquefied, sweetened, C4 fraction",92045-80-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4d4e47d-14d1-478e-ae10-3f95ec580073/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_10bb6471-6c82-47f8-913d-aa75b19c1f2c.html,,inhalation,LC50,"22,948 mg/m3",no adverse effect observed, "Residues (petroleum), atmospheric",68333-22-2," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc346e33-46be-4ae7-8f87-c8cfd0b06fd7/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_edb3e636-5d9a-480b-bcd3-0a09166843c5.html,,,,,, "Residues (petroleum), atmospheric",68333-22-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc346e33-46be-4ae7-8f87-c8cfd0b06fd7/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_edb3e636-5d9a-480b-bcd3-0a09166843c5.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Residues (petroleum), atmospheric",68333-22-2,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc346e33-46be-4ae7-8f87-c8cfd0b06fd7/documents/12190120-6b6e-49c5-bed7-264eab246437_edb3e636-5d9a-480b-bcd3-0a09166843c5.html,,,,,, "Residues (petroleum), atmospheric",68333-22-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc346e33-46be-4ae7-8f87-c8cfd0b06fd7/documents/12190120-6b6e-49c5-bed7-264eab246437_edb3e636-5d9a-480b-bcd3-0a09166843c5.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Residues (petroleum), atmospheric",68333-22-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc346e33-46be-4ae7-8f87-c8cfd0b06fd7/documents/12190120-6b6e-49c5-bed7-264eab246437_edb3e636-5d9a-480b-bcd3-0a09166843c5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), atmospheric",68333-22-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc346e33-46be-4ae7-8f87-c8cfd0b06fd7/documents/12190120-6b6e-49c5-bed7-264eab246437_edb3e636-5d9a-480b-bcd3-0a09166843c5.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, Lubricating oils,74869-22-0,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7d668fd-7caa-4318-91c8-558199f081e9/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_91257d84-58c1-497d-b7fb-e96ba94fb623.html,,,,,, Lubricating oils,74869-22-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7d668fd-7caa-4318-91c8-558199f081e9/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_91257d84-58c1-497d-b7fb-e96ba94fb623.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat Lubricating oils,74869-22-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7d668fd-7caa-4318-91c8-558199f081e9/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_91257d84-58c1-497d-b7fb-e96ba94fb623.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat Lubricating oils,74869-22-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7d668fd-7caa-4318-91c8-558199f081e9/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_91257d84-58c1-497d-b7fb-e96ba94fb623.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse Lubricating oils,74869-22-0,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7d668fd-7caa-4318-91c8-558199f081e9/documents/73761dae-46d6-428e-8e40-e5cc70088d96_91257d84-58c1-497d-b7fb-e96ba94fb623.html,,,,,, Lubricating oils,74869-22-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7d668fd-7caa-4318-91c8-558199f081e9/documents/73761dae-46d6-428e-8e40-e5cc70088d96_91257d84-58c1-497d-b7fb-e96ba94fb623.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Lubricating oils,74869-22-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7d668fd-7caa-4318-91c8-558199f081e9/documents/73761dae-46d6-428e-8e40-e5cc70088d96_91257d84-58c1-497d-b7fb-e96ba94fb623.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Lubricating oils,74869-22-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7d668fd-7caa-4318-91c8-558199f081e9/documents/73761dae-46d6-428e-8e40-e5cc70088d96_91257d84-58c1-497d-b7fb-e96ba94fb623.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "1,2,4-triazole",288-88-0,"NOAEL (oral) = 500 ppm of 1,2,4-triazole in feed (37.85 mg/kg bw/d in males ; 54.20 mg/kg bw/d in females). ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13df6b1b-2935-47c4-9ec9-d061b7ccc502/documents/IUC5-e7a13cf5-e579-4ce4-b00c-2bedf2f8bb8a_ec91a9f9-742d-4eee-9dfd-24e5f0b94e72.html,,,,,, "1,2,4-triazole",288-88-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13df6b1b-2935-47c4-9ec9-d061b7ccc502/documents/IUC5-e7a13cf5-e579-4ce4-b00c-2bedf2f8bb8a_ec91a9f9-742d-4eee-9dfd-24e5f0b94e72.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,37.85 mg/kg bw/day,,rat "1,2,4-triazole",288-88-0,"Acute oral : LD50 is 1320 mg/kg bw in rat exposed to 1,2,4-triazole (GLP guideline study).Acute dermal : LD50 is higher to 2000 mg/kg bw in rat exposed to 1,2,4-triazole (GLP guideline (OECD 402) study).Acute inhalation : No reliable study is available for this endpoint. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13df6b1b-2935-47c4-9ec9-d061b7ccc502/documents/IUC5-205f7bba-80c1-40b6-b63b-100696c69675_ec91a9f9-742d-4eee-9dfd-24e5f0b94e72.html,,,,,, "1,2,4-triazole",288-88-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13df6b1b-2935-47c4-9ec9-d061b7ccc502/documents/IUC5-205f7bba-80c1-40b6-b63b-100696c69675_ec91a9f9-742d-4eee-9dfd-24e5f0b94e72.html,,oral,LD50,"1,320 mg/kg bw",adverse effect observed, "1,2,4-triazole",288-88-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13df6b1b-2935-47c4-9ec9-d061b7ccc502/documents/IUC5-205f7bba-80c1-40b6-b63b-100696c69675_ec91a9f9-742d-4eee-9dfd-24e5f0b94e72.html,,dermal,LD50,"3,129 mg/kg bw",adverse effect observed, 4-methyl-m-phenylenediamine,95-80-7,"LOAEL (oral, 103 wk, rat m/f) = 5.9 mg/kg bw/day ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36594441-ef6f-4f39-96d3-0d74a579a7d5/documents/IUC5-931ad257-6867-4fb9-9eb9-477f1c86a63b_d188cb91-79eb-40bd-a3aa-fad87ffdd71b.html,,,,,, 4-methyl-m-phenylenediamine,95-80-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36594441-ef6f-4f39-96d3-0d74a579a7d5/documents/IUC5-931ad257-6867-4fb9-9eb9-477f1c86a63b_d188cb91-79eb-40bd-a3aa-fad87ffdd71b.html,Chronic toxicity – systemic effects,oral,LOAEL,5.9 mg/kg bw/day,,rat 4-methyl-m-phenylenediamine,95-80-7,Oral LD50 (rat): 136 (male) and 73 (female) mg/kg bwDermal LD50 (rat): 1200 mg/kg bwInhalation: no data available ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36594441-ef6f-4f39-96d3-0d74a579a7d5/documents/IUC5-6aeaea52-dcbb-4894-a816-0ba0f43ce289_d188cb91-79eb-40bd-a3aa-fad87ffdd71b.html,,,,,, 4-methyl-m-phenylenediamine,95-80-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36594441-ef6f-4f39-96d3-0d74a579a7d5/documents/IUC5-6aeaea52-dcbb-4894-a816-0ba0f43ce289_d188cb91-79eb-40bd-a3aa-fad87ffdd71b.html,,oral,LD50,ca.73 mg/kg bw,adverse effect observed, 4-methyl-m-phenylenediamine,95-80-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36594441-ef6f-4f39-96d3-0d74a579a7d5/documents/IUC5-6aeaea52-dcbb-4894-a816-0ba0f43ce289_d188cb91-79eb-40bd-a3aa-fad87ffdd71b.html,,dermal,LD50,"1,200 mg/kg bw",adverse effect observed, "Distillates (petroleum), cracked steam-cracked petroleum distillates",68477-38-3,"Repeated dose toxicity data are not available for Fuel Oils streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene - when present at 10%). The available data on the marker constituent DCPD do not reveal any specific target organ toxicity of a severity that would warrant classification. Therefore, no classification or labelling is warranted for streams which only contain these components. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dbffc591-0996-4fbe-bdbf-de446a9be04e/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_092ddfad-cff4-4ba7-99b3-3e4bda286949.html,,,,,, "Distillates (petroleum), cracked steam-cracked petroleum distillates",68477-38-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dbffc591-0996-4fbe-bdbf-de446a9be04e/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_092ddfad-cff4-4ba7-99b3-3e4bda286949.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), cracked steam-cracked petroleum distillates",68477-38-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dbffc591-0996-4fbe-bdbf-de446a9be04e/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_092ddfad-cff4-4ba7-99b3-3e4bda286949.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Distillates (petroleum), cracked steam-cracked petroleum distillates",68477-38-3,"Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen.The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing =20% toluene.   Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing =20% toluene.   Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing =20% toluene. Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing =20% toluene. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbffc591-0996-4fbe-bdbf-de446a9be04e/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_092ddfad-cff4-4ba7-99b3-3e4bda286949.html,,,,,, "Distillates (petroleum), cracked steam-cracked petroleum distillates",68477-38-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbffc591-0996-4fbe-bdbf-de446a9be04e/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_092ddfad-cff4-4ba7-99b3-3e4bda286949.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), cracked steam-cracked petroleum distillates",68477-38-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbffc591-0996-4fbe-bdbf-de446a9be04e/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_092ddfad-cff4-4ba7-99b3-3e4bda286949.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), cracked steam-cracked petroleum distillates",68477-38-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbffc591-0996-4fbe-bdbf-de446a9be04e/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_092ddfad-cff4-4ba7-99b3-3e4bda286949.html,,inhalation,LC50,"1,600 mg/m3",no adverse effect observed, Isosorbide dinitrate,87-33-2,The oral LD50 value ranges from 747 mg/kg (rat) to 1050 mg/kg (mouse); the dermal LD50 is > 3000 mg/kg (rat). ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f9d145f-fbd9-4a06-b0ba-e238f1cc910d/documents/IUC5-028e84f9-0dcc-4c89-81b9-710c732ceafb_8858399f-d9e4-41ae-8298-549bf77ec8b9.html,,,,,, Isosorbide dinitrate,87-33-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f9d145f-fbd9-4a06-b0ba-e238f1cc910d/documents/IUC5-028e84f9-0dcc-4c89-81b9-710c732ceafb_8858399f-d9e4-41ae-8298-549bf77ec8b9.html,,oral,LD50,747 mg/kg bw,, "(R)-1-chloro-2,3-epoxypropane",51594-55-9,"Classified according to Regulation (EU) 1272/2008, Annex VI (Table 3.1/3.2) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/762f8c38-5438-4ea9-b262-3581e3c7d8d9/documents/73d54b2d-6d4e-4b47-8ca4-64d3f059dcf4_796101a7-1dc3-4175-9a0d-ae2392dedae2.html,,,,,, "(R)-1-chloro-2,3-epoxypropane",51594-55-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/762f8c38-5438-4ea9-b262-3581e3c7d8d9/documents/73d54b2d-6d4e-4b47-8ca4-64d3f059dcf4_796101a7-1dc3-4175-9a0d-ae2392dedae2.html,,oral,LD50,100 mg/kg bw,, "(R)-1-chloro-2,3-epoxypropane",51594-55-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/762f8c38-5438-4ea9-b262-3581e3c7d8d9/documents/73d54b2d-6d4e-4b47-8ca4-64d3f059dcf4_796101a7-1dc3-4175-9a0d-ae2392dedae2.html,,dermal,LD50,300 mg/kg bw,, "(R)-1-chloro-2,3-epoxypropane",51594-55-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/762f8c38-5438-4ea9-b262-3581e3c7d8d9/documents/73d54b2d-6d4e-4b47-8ca4-64d3f059dcf4_796101a7-1dc3-4175-9a0d-ae2392dedae2.html,,inhalation,,3 mg/L,, "Gases (petroleum), C3-4",68131-75-9,"Only one stream (Liquified Petroleum Gases CAS 68476 -85 -7) of the Other Petroleum Gases category has been tested but this and the main constituents of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and humans. The mammalian toxicity effects of this category will be driven by the content of benzene if the latter is present at levels of >10%. Additionally, the category may contain carbon monoxide which could trigger classification.   ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e9f3325-49b6-46a0-8b8e-030cd566fa9d/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_361b963b-ddaf-4995-8d7e-504f998f7bac.html,,,,,, "Gases (petroleum), C3-4",68131-75-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e9f3325-49b6-46a0-8b8e-030cd566fa9d/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_361b963b-ddaf-4995-8d7e-504f998f7bac.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"7,214 mg/m3",,rat "Gases (petroleum), C3-4",68131-75-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e9f3325-49b6-46a0-8b8e-030cd566fa9d/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_361b963b-ddaf-4995-8d7e-504f998f7bac.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"8,600 mg/m3",adverse effect observed,rat "Gases (petroleum), C3-4",68131-75-9,"Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the constituents. Across species, main constituent gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene in streams where it is present at levels of <1%. However, some streams in this category may contain benzene levels >1% or carbon monoxide which could trigger classification. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e9f3325-49b6-46a0-8b8e-030cd566fa9d/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_361b963b-ddaf-4995-8d7e-504f998f7bac.html,,,,,, "Gases (petroleum), C3-4",68131-75-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e9f3325-49b6-46a0-8b8e-030cd566fa9d/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_361b963b-ddaf-4995-8d7e-504f998f7bac.html,,inhalation,LC50,"22,948 mg/m3",no adverse effect observed, "Gases (petroleum), crude distn. and catalytic cracking",68989-88-8,"After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and in humans. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/024dbf24-7e11-496a-a7a0-2cc846af7f68/documents/c056898b-bfcd-467a-81f5-932d319271c5_fd7c762d-bf6a-4107-81ee-9a744ff8aca2.html,,,,,, "Gases (petroleum), crude distn. and catalytic cracking",68989-88-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/024dbf24-7e11-496a-a7a0-2cc846af7f68/documents/c056898b-bfcd-467a-81f5-932d319271c5_fd7c762d-bf6a-4107-81ee-9a744ff8aca2.html,Chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Gases (petroleum), crude distn. and catalytic cracking",68989-88-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/024dbf24-7e11-496a-a7a0-2cc846af7f68/documents/c056898b-bfcd-467a-81f5-932d319271c5_fd7c762d-bf6a-4107-81ee-9a744ff8aca2.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human (epidemiological findings) "Gases (petroleum), crude distn. and catalytic cracking",68989-88-8," Benzene does not pose an acute hazard following ingestion (oral LD50 > 2000 mg/kg), skin contact (dermal LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/024dbf24-7e11-496a-a7a0-2cc846af7f68/documents/d5c4a791-dd55-400f-823a-3a66c0f7cf91_fd7c762d-bf6a-4107-81ee-9a744ff8aca2.html,,,,,, "Gases (petroleum), crude distn. and catalytic cracking",68989-88-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/024dbf24-7e11-496a-a7a0-2cc846af7f68/documents/d5c4a791-dd55-400f-823a-3a66c0f7cf91_fd7c762d-bf6a-4107-81ee-9a744ff8aca2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gases (petroleum), crude distn. and catalytic cracking",68989-88-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/024dbf24-7e11-496a-a7a0-2cc846af7f68/documents/d5c4a791-dd55-400f-823a-3a66c0f7cf91_fd7c762d-bf6a-4107-81ee-9a744ff8aca2.html,,dermal,LD50,"8,260 mg/kg bw",no adverse effect observed, "Gases (petroleum), crude distn. and catalytic cracking",68989-88-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/024dbf24-7e11-496a-a7a0-2cc846af7f68/documents/d5c4a791-dd55-400f-823a-3a66c0f7cf91_fd7c762d-bf6a-4107-81ee-9a744ff8aca2.html,,inhalation,LC50,"43,767 mg/m3",no adverse effect observed, "Residual oils (petroleum), solvent-dewaxed",64742-62-7,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34895cd9-14c7-4b93-845b-660c6f7364e8/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_1cc5d3fa-a779-4131-85b1-5d07b20e1c06.html,,,,,, "Residual oils (petroleum), solvent-dewaxed",64742-62-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34895cd9-14c7-4b93-845b-660c6f7364e8/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_1cc5d3fa-a779-4131-85b1-5d07b20e1c06.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Residual oils (petroleum), solvent-dewaxed",64742-62-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34895cd9-14c7-4b93-845b-660c6f7364e8/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_1cc5d3fa-a779-4131-85b1-5d07b20e1c06.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Residual oils (petroleum), solvent-dewaxed",64742-62-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34895cd9-14c7-4b93-845b-660c6f7364e8/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_1cc5d3fa-a779-4131-85b1-5d07b20e1c06.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Residual oils (petroleum), solvent-dewaxed",64742-62-7,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34895cd9-14c7-4b93-845b-660c6f7364e8/documents/73761dae-46d6-428e-8e40-e5cc70088d96_1cc5d3fa-a779-4131-85b1-5d07b20e1c06.html,,,,,, "Residual oils (petroleum), solvent-dewaxed",64742-62-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34895cd9-14c7-4b93-845b-660c6f7364e8/documents/73761dae-46d6-428e-8e40-e5cc70088d96_1cc5d3fa-a779-4131-85b1-5d07b20e1c06.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Residual oils (petroleum), solvent-dewaxed",64742-62-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34895cd9-14c7-4b93-845b-660c6f7364e8/documents/73761dae-46d6-428e-8e40-e5cc70088d96_1cc5d3fa-a779-4131-85b1-5d07b20e1c06.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residual oils (petroleum), solvent-dewaxed",64742-62-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34895cd9-14c7-4b93-845b-660c6f7364e8/documents/73761dae-46d6-428e-8e40-e5cc70088d96_1cc5d3fa-a779-4131-85b1-5d07b20e1c06.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Distillates (petroleum), solvent-refined heavy naphthenic",64741-96-4,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b2d5274-1647-4298-ae93-b50903393517/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_88edec65-ac96-4467-9908-f0119b76d620.html,,,,,, "Distillates (petroleum), solvent-refined heavy naphthenic",64741-96-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b2d5274-1647-4298-ae93-b50903393517/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_88edec65-ac96-4467-9908-f0119b76d620.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Distillates (petroleum), solvent-refined heavy naphthenic",64741-96-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b2d5274-1647-4298-ae93-b50903393517/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_88edec65-ac96-4467-9908-f0119b76d620.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Distillates (petroleum), solvent-refined heavy naphthenic",64741-96-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b2d5274-1647-4298-ae93-b50903393517/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_88edec65-ac96-4467-9908-f0119b76d620.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Distillates (petroleum), solvent-refined heavy naphthenic",64741-96-4,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b2d5274-1647-4298-ae93-b50903393517/documents/73761dae-46d6-428e-8e40-e5cc70088d96_88edec65-ac96-4467-9908-f0119b76d620.html,,,,,, "Distillates (petroleum), solvent-refined heavy naphthenic",64741-96-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b2d5274-1647-4298-ae93-b50903393517/documents/73761dae-46d6-428e-8e40-e5cc70088d96_88edec65-ac96-4467-9908-f0119b76d620.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), solvent-refined heavy naphthenic",64741-96-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b2d5274-1647-4298-ae93-b50903393517/documents/73761dae-46d6-428e-8e40-e5cc70088d96_88edec65-ac96-4467-9908-f0119b76d620.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), solvent-refined heavy naphthenic",64741-96-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b2d5274-1647-4298-ae93-b50903393517/documents/73761dae-46d6-428e-8e40-e5cc70088d96_88edec65-ac96-4467-9908-f0119b76d620.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, 3-chloropropene,107-05-1,"- Repeated dose toxicity, oral: no reliable study available- Repeated dose toxicity, dermal: no study available- Repeated dose toxicity, inhalation: NOAEC = 10 ppm (=31 mg/m³) for the rat, (neurotoxicity study); Nagano 1991 ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80d316ae-9add-4029-a547-d97511c3ad26/documents/IUC5-21137e24-1c87-4e27-9a52-040d04bb281b_8d54e959-9dac-4784-8f49-a1b4e58a69f6.html,,,,,, 3-chloropropene,107-05-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80d316ae-9add-4029-a547-d97511c3ad26/documents/IUC5-21137e24-1c87-4e27-9a52-040d04bb281b_8d54e959-9dac-4784-8f49-a1b4e58a69f6.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,31 mg/m3,, 3-chloropropene,107-05-1,"- Oral: LD50: 275 mg/kg bw (180 — 526, 95 % CL) for the rat (OECD TG 401); study Henck (1980)- Dermal: LD50: 398 mg/Kg bw for the rabbit (non-guideline test); Dow K-1720-4A- Inhalation: LC50: 2900 mg/kg bw for the male guinea pig (generally compliant to OECD TG 403); study Lu (1982) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80d316ae-9add-4029-a547-d97511c3ad26/documents/IUC5-ed50e648-577b-4b16-bbf6-35aa55bd9669_8d54e959-9dac-4784-8f49-a1b4e58a69f6.html,,,,,, 3-chloropropene,107-05-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80d316ae-9add-4029-a547-d97511c3ad26/documents/IUC5-ed50e648-577b-4b16-bbf6-35aa55bd9669_8d54e959-9dac-4784-8f49-a1b4e58a69f6.html,,oral,LD50,275 mg/kg bw,, 3-chloropropene,107-05-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80d316ae-9add-4029-a547-d97511c3ad26/documents/IUC5-ed50e648-577b-4b16-bbf6-35aa55bd9669_8d54e959-9dac-4784-8f49-a1b4e58a69f6.html,,dermal,LD50,398 mg/kg bw,, 3-chloropropene,107-05-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80d316ae-9add-4029-a547-d97511c3ad26/documents/IUC5-ed50e648-577b-4b16-bbf6-35aa55bd9669_8d54e959-9dac-4784-8f49-a1b4e58a69f6.html,,inhalation,LC50,"2,900 mg/m3",, Monuron,150-68-5," Supporting subacute oral toxicity studies were available in rats either by oral gavage (at 450, 500 and 1500 mg/kg bw) or in the diet (at 0.005, 0.05, and 0.5%, corresponding with 5, 50 and 500 mg/kg bw). Mortality was observed at 500 and 1500 mg/kg bw, whereas no mortality was seen at 450 mg/kg by oral gavage and in the diet study up to 0.5% (500 mg/kg bw). General signs of toxicity to rats are those of methemoglobinemia, such as cyanosis, enlarged dark spleen, and compensatory red blood cell (RBC) formation in the spleen and bone marrow. Dead animals generally show pulmonary edema, congestion, and hemorrhagy accompanied by anemia of liver, kidneys, and spleen. A NOAEL was not defined in the subacute toxicity studies; the dose of 5 mg/kg bw in the rat subacute toxicity study can be considered as Lowest Adverse Effect Level (LOAEL). A key oral subchronic 13-week toxicity study in rats and supporting oral 13-week toxicity study in mice were available by dietary administration in both species. Effective concentrations in the rat were 0, 900, 1800, 3200, 7200 and 12400 ppm, corresponding with 72, 144, 256, 576 and 992 mg/kg bw. Effective concentrations were 3200, 7000, 12400, 28100 and 49800 ppm in the mouse, corresponding with 640, 1400, 2480, 5620 and 9960 mg/kg bw. Mortality and lymphoid depletion in the spleen, thymus and bone marrow were observed in both species at higher dose levels, whereas body weight changes (rats & mice) or observation in the lungs, stomach and adrenal glands (rats) were noted at lower dosages. As the studies were intended for dose selection of the carcinogenicity studies, A NOAEL was not defined in the subchronic toxicity studies. The dietary concentration of 900 ppm (72 mg/kg bw) in the key rat subchronic toxicity study can be considered as Lowest Adverse Effect Level (LOAEL). ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd8a74b7-0854-4e31-aa83-288ab713f21f/documents/c8088ff8-e0f2-4d5c-85f4-0dec17fedfad_010065a7-4d7e-41ac-b20b-68ee34efaa49.html,,,,,, Monuron,150-68-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd8a74b7-0854-4e31-aa83-288ab713f21f/documents/c8088ff8-e0f2-4d5c-85f4-0dec17fedfad_010065a7-4d7e-41ac-b20b-68ee34efaa49.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,5 mg/kg bw/day,,rat Monuron,150-68-5," Several acute oral toxicity studies were performed in rats with key lowest LD50 value in adult male and female rats of 1226 and 1053 mg/kg bw , respectively, and 2232 mg/kg bw in male weanling rats. Supporting studies showed oral LD50 value up to 3600 mg/kg bw in rats and 1920 mg/kg bw in mice. Acute inhalation toxicity was waived based upon the low vapor pressure of Monuron (5.03E-07 mm Hg). Acute dermal toxicity studies were performed in rats and rabbits, with key LD50 value in adult male and female rats > 2500 mg/kg bw ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd8a74b7-0854-4e31-aa83-288ab713f21f/documents/da29ce33-5a04-4b41-bd5d-69a16d6d8c2b_010065a7-4d7e-41ac-b20b-68ee34efaa49.html,,,,,, Monuron,150-68-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd8a74b7-0854-4e31-aa83-288ab713f21f/documents/da29ce33-5a04-4b41-bd5d-69a16d6d8c2b_010065a7-4d7e-41ac-b20b-68ee34efaa49.html,,oral,LD50,"1,053 ",adverse effect observed, Monuron,150-68-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd8a74b7-0854-4e31-aa83-288ab713f21f/documents/da29ce33-5a04-4b41-bd5d-69a16d6d8c2b_010065a7-4d7e-41ac-b20b-68ee34efaa49.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, 4-tert-butylpyrocatechol,98-29-3," The key study for this endpoint is a 90-day (14-week) study in both rats and mice by dietary administration, with NOAELs lower than 781 ppm (approximately 70 mg/kg) or equal to 1562 ppm (approximately 300 mg/kg), respectively, based on forestomach microscopic lesions, which are of low toxicological relevance to the human situation. In rats, there was also evidence of a transient hepatic effect, as indicated by increased serum alanine aminotransferase activites and bile salt concentrations in exposed males and females. Alanine aminotransferase activities were increased in all exposed groups of females. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a33149e-48da-41ed-81ce-4fc01d763fe0/documents/IUC5-27d0d23b-4650-4838-919a-37b9f4a40b26_18dc3247-bd2a-448f-932f-a7c2d4576cf2.html,,,,,, 4-tert-butylpyrocatechol,98-29-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a33149e-48da-41ed-81ce-4fc01d763fe0/documents/IUC5-27d0d23b-4650-4838-919a-37b9f4a40b26_18dc3247-bd2a-448f-932f-a7c2d4576cf2.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,70 mg/kg bw/day,,rat 4-tert-butylpyrocatechol,98-29-3,LD50 oral = 815 mg/kg bw (95% C.I.: 643-1049 mg/kg)LD50 dermal = 1331 mg/kg bw (95% C.I.: 954-1863 mg/kg) ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a33149e-48da-41ed-81ce-4fc01d763fe0/documents/IUC5-aa047304-f9a1-46f3-be2f-3fd0c5dd181f_18dc3247-bd2a-448f-932f-a7c2d4576cf2.html,,,,,, 4-tert-butylpyrocatechol,98-29-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a33149e-48da-41ed-81ce-4fc01d763fe0/documents/IUC5-aa047304-f9a1-46f3-be2f-3fd0c5dd181f_18dc3247-bd2a-448f-932f-a7c2d4576cf2.html,,oral,LD50,815 mg/kg bw,adverse effect observed, 4-tert-butylpyrocatechol,98-29-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a33149e-48da-41ed-81ce-4fc01d763fe0/documents/IUC5-aa047304-f9a1-46f3-be2f-3fd0c5dd181f_18dc3247-bd2a-448f-932f-a7c2d4576cf2.html,,dermal,LD50,"1,331 mg/kg bw",adverse effect observed, "Gases (petroleum), C2-4, sweetened",68783-65-3,"Only one stream (Liquified Petroleum Gases CAS 68476 -85 -7) of the Other Petroleum Gases category has been tested but this and the main constituents of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and humans. The mammalian toxicity effects of this category will be driven by the content of benzene if the latter is present at levels of >10%. Additionally, the category may contain carbon monoxide which could trigger classification.   ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f52228f-c405-4f9d-b5d8-614dd42f508c/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_e36346ca-4db3-4bfb-928a-7b31742ab9eb.html,,,,,, "Gases (petroleum), C2-4, sweetened",68783-65-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f52228f-c405-4f9d-b5d8-614dd42f508c/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_e36346ca-4db3-4bfb-928a-7b31742ab9eb.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"7,214 mg/m3",,rat "Gases (petroleum), C2-4, sweetened",68783-65-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f52228f-c405-4f9d-b5d8-614dd42f508c/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_e36346ca-4db3-4bfb-928a-7b31742ab9eb.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"8,600 mg/m3",adverse effect observed,rat "Gases (petroleum), C2-4, sweetened",68783-65-3,"Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the constituents. Across species, main constituent gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene in streams where it is present at levels of <1%. However, some streams in this category may contain benzene levels >1% or carbon monoxide which could trigger classification. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f52228f-c405-4f9d-b5d8-614dd42f508c/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_e36346ca-4db3-4bfb-928a-7b31742ab9eb.html,,,,,, "Gases (petroleum), C2-4, sweetened",68783-65-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f52228f-c405-4f9d-b5d8-614dd42f508c/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_e36346ca-4db3-4bfb-928a-7b31742ab9eb.html,,inhalation,LC50,"22,948 mg/m3",no adverse effect observed, "Pyridine-2-thiol 1-oxide, sodium salt",3811-73-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21b90404-2394-4cde-b206-bd8cac7892a3/documents/IUC5-2d19b205-5e0d-4713-ab94-4d035efdf4b3_0047576f-b9c0-43dd-a3b9-2b53c1fe3bc9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.5 mg/kg bw/day,,rat "Pyridine-2-thiol 1-oxide, sodium salt",3811-73-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21b90404-2394-4cde-b206-bd8cac7892a3/documents/IUC5-2d19b205-5e0d-4713-ab94-4d035efdf4b3_0047576f-b9c0-43dd-a3b9-2b53c1fe3bc9.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.46 mg/m3,,rat "Pyridine-2-thiol 1-oxide, sodium salt",3811-73-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21b90404-2394-4cde-b206-bd8cac7892a3/documents/IUC5-2d19b205-5e0d-4713-ab94-4d035efdf4b3_0047576f-b9c0-43dd-a3b9-2b53c1fe3bc9.html,Chronic toxicity – systemic effects,dermal,NOAEL,5 mg/kg bw/day,,rat "Pyridine-2-thiol 1-oxide, sodium salt",3811-73-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21b90404-2394-4cde-b206-bd8cac7892a3/documents/IUC5-108729bf-8443-4bef-8e83-ac937642db48_0047576f-b9c0-43dd-a3b9-2b53c1fe3bc9.html,,oral,LD50,"1,208 mg/kg bw",, "Pyridine-2-thiol 1-oxide, sodium salt",3811-73-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21b90404-2394-4cde-b206-bd8cac7892a3/documents/IUC5-108729bf-8443-4bef-8e83-ac937642db48_0047576f-b9c0-43dd-a3b9-2b53c1fe3bc9.html,,dermal,LD50,"2,000 mg/kg bw",, "Pyridine-2-thiol 1-oxide, sodium salt",3811-73-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21b90404-2394-4cde-b206-bd8cac7892a3/documents/IUC5-108729bf-8443-4bef-8e83-ac937642db48_0047576f-b9c0-43dd-a3b9-2b53c1fe3bc9.html,,inhalation,LC50,1.08 mg/m3,, "Extracts (petroleum), heavy paraffinic distillate solvent",64742-04-7,"NOAEL for heavy paraffinic distillate aromatic extract could not be identified in a 90-day oral study (equivalent to OECD 408) and is less than 125 mg/kg/day when administered orally to male rats.  Systemic toxicity was observed in a 90-day dermal study (equivalent to OECD 411) in rats exposed to heavy paraffinic DAE (CAS number 64742-04-7).  A NOAEL could not be established since toxicity was observed at all dosing levels, including the lowest dose tested. The authors considered the NOAEL for dermal exposure to be less than 30 mg/kg/day.  In a 28-day dermal study (equivalent to OECD 410), no signs of systemic toxicity were observed in rabbits even at the high dose, 1000 mg/kg/day.   ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05c4fb98-a144-4d36-b319-d4889b71538e/documents/7bbda247-3440-4298-a989-84c2d1a494ff_5ac41cc0-c0e3-4021-ac6d-b95dc033ba76.html,,,,,, "Extracts (petroleum), heavy paraffinic distillate solvent",64742-04-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05c4fb98-a144-4d36-b319-d4889b71538e/documents/7bbda247-3440-4298-a989-84c2d1a494ff_5ac41cc0-c0e3-4021-ac6d-b95dc033ba76.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Extracts (petroleum), heavy paraffinic distillate solvent",64742-04-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05c4fb98-a144-4d36-b319-d4889b71538e/documents/7bbda247-3440-4298-a989-84c2d1a494ff_5ac41cc0-c0e3-4021-ac6d-b95dc033ba76.html,Sub-chronic toxicity – systemic effects,dermal,LOAEL,30 mg/kg bw/day,,rat "Extracts (petroleum), heavy paraffinic distillate solvent",64742-04-7,"Key acute oral (similar to OECD 401), dermal (similar to OECD 402), and inhalation (OECD 403)  toxicity studies (OECD 420) were identified.• The oral LD50 was > 5000 mg/kg bw in male and female rats for light paraffinic DAE.• The inhalation LC50 was > 5 mg/L for DAE.• The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for light paraffinic DAE. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05c4fb98-a144-4d36-b319-d4889b71538e/documents/49623972-9bec-41a1-849e-1214cef6d1d9_5ac41cc0-c0e3-4021-ac6d-b95dc033ba76.html,,,,,, "Extracts (petroleum), heavy paraffinic distillate solvent",64742-04-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05c4fb98-a144-4d36-b319-d4889b71538e/documents/49623972-9bec-41a1-849e-1214cef6d1d9_5ac41cc0-c0e3-4021-ac6d-b95dc033ba76.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Extracts (petroleum), heavy paraffinic distillate solvent",64742-04-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05c4fb98-a144-4d36-b319-d4889b71538e/documents/49623972-9bec-41a1-849e-1214cef6d1d9_5ac41cc0-c0e3-4021-ac6d-b95dc033ba76.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Extracts (petroleum), heavy paraffinic distillate solvent",64742-04-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05c4fb98-a144-4d36-b319-d4889b71538e/documents/49623972-9bec-41a1-849e-1214cef6d1d9_5ac41cc0-c0e3-4021-ac6d-b95dc033ba76.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Arsenic,7440-38-2," Read across approach In the absence of substance-specific data, the repeated dose toxicity of arsenic metal is assessed based on reviews and/or data for inorganic arsenic compounds. Although arsenic metal has a limited solubility, it is not completely inert when immersed in water or biological fluids (see sections on Water solubility and Toxicokinetics), so that dissolved ionic species (predominantly As(III)) may be released from the metal. Following a conservative approach, the toxicity of arsenic metal is therefore considered to be determined by the release of soluble inorganic species (trivalent arsenites and pentavalent arsenates) which do not differ substantially in potency and may be interconverted both in the environment and in the body. Consequently, it is justified to apply read across to soluble inorganic arsenic compounds to evaluate the systemic effects, including repeated dose toxicity, of arsenic metal. General remarks A large number of investigations in animals and humans on the toxic effects of inorganic arsenic compounds following repeated exposure are available, and these have been reviewed on several occasions by renowned scientific organizations. Given the overwhelming volume of data, individual Robust Study Summaries (RSS) were not developed. Instead, an overview of available investigations is presented below. When evaluating the results of the animal and human studies, it is important to remember that there are considerable differences in arsenic biotransformation between species and between individuals of a same species (see section on Toxicokinetics). Also, a number of aspects raise issues regarding the usefulness of some studies for quantifying, comparing and interpreting results, especially regarding relevance to humans and risk assessment. These include definition of the arsenic species analysed, concentrations/doses, types of cells, simulation of natural exposure for example (Cohen et al., 2013). It is generally considered that trivalent arsenic compounds are more toxic than the pentavalent forms, at least at high doses. However, the difference is difficult to quantify since a conversion between trivalent and pentavalent arsenic can occur after the substance has entered the body (ATSDR, 2007). Furthermore, exposure via the oral and inhalation routes is the most relevant for hazard and risk assessment of inorganic arsenic compounds. Dermal absorption is low (see section on Toxicokinetics), so that no significant systemic exposure is expected via this route. The following paragraphs summarise the data available on the inhalation and oral toxicity of inorganic arsenic compounds. Data on humans is presented first, followed by studies conducted in animals. Inhalation exposure Effects in humans Respiratory effects: Workers exposed to arsenic dusts in air often experience irritation to the mucous membranes of the nose and throat, which may lead to laryngitis, bronchitis or rhinitis, and very high exposures characteristic of workplace exposures in the past can cause perforation of the nasal septum. However, there have been few systematic investigations of respiratory effects in humans exposed to arsenic. None are considered to be conclusive with regard to the relationship between inhaled inorganic arsenic and respiratory disease (ATSDR, 2007). Cardiovascular effects: There is some evidence from epidemiological studies that inhaled inorganic arsenic can produce effects on the cardiovascular system, but such effects resulting from oral exposure are better characterized (ATSDR, 2007). Gastrointestinal effects: Several case studies have reported nausea, vomiting and diarrhoea in workers with acute arsenic poisoning following occupational inhalation exposure. Such effects are a common feature of oral ingestion of high doses of arsenic but exposure levels have not been reliably estimated for any of these cases (ATSDR, 2007). Neurological effects: There is evidence from epidemiological studies that inhaled inorganic arsenic can produce neurological effects. Studies of workers at the ASARCO copper smelter (USA), a power station in Slovakia and the Ronnskar smelter (Sweden) demonstrated peripheral neurological effects in workers associated with arsenic trioxide exposure (ATSDR, 2007). However, the exposure levels were difficult to quantify. Dermal effects: Dermatitis has frequently been observed in industrial workers exposed to inorganic arsenic in the air, with the highest rates occurring in workers with the greatest arsenic exposure. However, limited quantitative information is available regarding the levels that produce such dermatitis and co-exposure to other substances in the workplace by the dermal route makes a dose-response analysis difficult. The highest arsenic exposures (0.384-0.034 mg As/m3) were associated with gross pigmentation, hyperkeratinisation and multiple warts. NOAEL values for dermal irritation have not been identified (ATSDR, 2007). Other organ systems: There is no reliable evidence in humans that inhaled inorganic arsenic produces effects on other important organ systems such as liver, kidneys or the haematological, immunological and musculoskeletal systems. Effects in animals Respiratory and gastrointestinal effects: Respiratory symptoms such as rales (8 mg As/m3), laboured breathing and gasping (20 mg As/m3) were observed in a developmental study in rats with inhalation exposure to arsenic trioxide dust, with no symptoms at 2 mg As/m3. Since this sort of response is produced by a number of respirable particulate materials, it is likely that the inflammatory response was not specifically due to arsenic. Upon autopsy, some of the animals exposed to 20 mg As/m3 exhibited severe hyperaemia and plasma discharge into the intestinal lumen, whereas exposure to 8 mg As/m3 did not produce gross gastrointestinal lesions (Holson et al., 1999) (ATSDR, 2007). Immunological effects: Female mice exposed to arsenic trioxide aerosol for 3 hours showed a concentration-related decrease in pulmonary bactericidal activity, presumably as a result of injury to alveolar macrophages, and a corresponding concentration-related increase in susceptibility to introduced respiratory bacterial pathogens (Aranyi et al., 1985) (ATSDR, 2007). Other organ systems: There is no reliable evidence in animals that inhaled inorganic arsenic produces effects on other important organ systems such as liver, kidneys, skin or the haematological, immunological, cardiovascular and musculoskeletal systems (ATSDR, 2007). Oral toxicity Effects in humans There is a large body of studies in humans and animals on the toxic effects of ingested arsenic. In humans, most cases result from accidental, suicidal, homicidal or medicinal ingestion of arsenic-containing powders or solutions, or from consumption of contaminated food and drinking water. In many cases, the exact chemical form of arsenic is not known; however, it is presumed that the most likely forms are either pentavalent arsenate, trivalent arsenite or a mixture of both. Respiratory effects: Bronchitis and sequelae (bronchiectasis, bronchopneumonia) have been observed in patients and at autopsy in some chronic poisoning cases (Guha Mazumder et al. 2005; Milton and Rahman, 2002; Rosenberg, 1974; Tsai, et al. 1999; Zaldívar, 1974; Zaldívar and Guillier, 1977). Bronchopneumonia secondary to arsenic-induced bronchitis was considered to be the cause of death in one young child after several years of exposure to an average dose of 0.08 mg As/kg/day (Zaldívar and Guillier 1977). Decrements in lung function, measured as decreased FEV1, FVC and FEF25–75 have also been reported in subjects exhibiting skin lesions exposed to 0.1–0.5 mg As/L in drinking water (von Ehrenstein et al., 2005). Although in general respiratory effects have not been widely associated with repeated oral ingestion of low arsenic doses, a few studies have reported minor respiratory symptoms, such as cough, sputum, rhinorrhoea and sore throat in people with repeated oral exposure to 0.03–0.05 mg As/kg/day (Ahmad et al., 1997; Mizuta et al., 1956) (ATSDR, 2007). In a recent study, the respiratory effects of chronic low-level arsenic exposure from groundwater were evaluated in West Bengal, India, with the participants (834 non-smoking adult males) were subdivided in two groups: an arsenic-exposed group (n = 446, mean age 35.3 years) drinking arsenic-contaminated groundwater (11–50μg/L) and a control group of 388 age-matched men drinking water containing <10μg/L of arsenic. Arsenic in water samples was measured by atomic absorption spectroscopy. The prevalence of respiratory symptoms was documented via a structured, validated questionnaire. Pulmonary function test (PFT) was assessed by portable spirometer. Compared with controls, the arsenic-exposed subjects had a higher prevalence of upper and lower respiratory symptoms, dyspnoea, asthma, eye irritation and headache. Also, 20.6% of arsenic-exposed subjects had lung function deficits (predominantly restrictive and combined types) compared with 13.6% of control (p < 0.05). A positive association was observed between arsenic concentration in drinking water and the prevalence of respiratory symptoms, while a negative association existed between arsenic level and spirometric parameters. Based on the study results, the study author suggested that even low-level arsenic exposure has deleterious respiratory effects (Das et al., 2014). To evaluate the chronic effects of arsenic poisoning due to consumption of contaminated groundwater, a non-randomized, controlled, cross-sectional, observational study was carried out in the Arsenic Clinic, Institute of Postgraduate Medical Education and Research, Kolkata, West Bengal, over a period of 1 year and 4 months. Seventy-three cases diagnosed clinically, consuming water containing arsenic ≥50μg/L and having arsenic levels in hair and nails >0.6μg/L, were included. Special investigations included routine parameters and organ-specific tests. Arsenic levels in drinking water, hair and nails were measured. Twenty-five non-smoking healthy controls were evaluated. Murshidabad and districts adjacent to Kolkata, West Bengal, were mostly affected. Middle-aged males were the main sufferers. Skin involvement was the most common manifestation (100%), followed by hepatomegaly [23 (31.5%)] with or without transaminitis [7 (9.58%)]/portal hypertension [9 (12.33%)]. Restrictive abnormality in spirometry [11 (15.06%)], bronchiectasis [4 (5.47%)], interstitial fibrosis [2 (2.73%)], bronchogenic carcinoma [2 (2.73%)], oromucosal plaque [7 (9.58%)], nail hypertrophy [10 (13.69%)], alopecia [8 (10.95%)], neuropathy [5 (6.84%)] and electrocardiography abnormalities [5 (6.84%)] were also observed. Based on the study results, the author concluded that mucocutaneous and nail lesions, hepatomegaly and restrictive change in spirometry were the common and significant findings in the study (Ghosh, 2013). Cardiovascular effects: A number of studies in humans indicate that arsenic ingestion may lead to serious effects on the cardiovascular system. Characteristic effects on the heart from both acute and long-term exposure include altered myocardial depolarization (prolonged QT interval, nonspecific ST segment changes) and cardiac arrhythmia (Cullen et al., 1995; Glazener et al., 1968; Goldsmith and From, 1986; Heyman et al., 1956; Little et al., 1990; Mizuta et al., 1956; Moore et al., 1994b; Mumford et al., 2007). A significant dose-related increase in the prevalence of cardiac electrophysiological abnormalities was observed in residents of Inner Mongolia, China; the incidences of QT prolongation were observed in 3.9, 11.1 and 20.6% of the residents with drinking water levels of <21, 110–300, and 430–690μg/L, respectively (Mumford et al., 2007). Long-term exposure to low to moderate arsenic levels was associated with cardiovascular disease and mortality in a population of American Indians men and women aged 47 to 74 in Arizona, Oklahoma and North/South Dakota (US) (Moon, 2013). Most dramatic is “Blackfoot Disease,” a condition that is endemic in an area of Taiwan where average drinking water levels of arsenic range from 0.17-0.80 ppm (Tseng, 1977), corresponding to doses of about 0.014–0.065 mg As/kg/day (IRIS, 2007). The disease is characterised by a progressive loss of circulation in the hands and feet, leading ultimately to necrosis and gangrene (Chen et al., 1988b; Ch’i and Blackwell, 1968; Tseng, 1977, 1989; Tseng et al., 1968, 1995, 1996). Despite other factors being suspected of playing a role in the etiology of this disease (Ko, 1986; Lu et al., 1990; Yu et al., 1984), the clear association between the occurrence of Blackfoot Disease and the intake of elevated arsenic levels indicates that arsenic is at least a contributing factor. Arsenic exposure in Taiwan has also been associated with an increased incidence of cerebrovascular and microvascular diseases (Chiou et al., 1997; Wang et al., 2002, 2003) and ischemic heart disease (Chang et al., 2004; Chen et al., 1996; Hsueh et al., 1998b; Tsai et al., 1999; Tseng et al., 2003). Hypertension, defined as a systolic blood pressure of ≥140 mm Hg in combination with a diastolic blood pressure of ≥90 mm Hg, was associated with estimated lifetime doses of approximately 0.055 mg As/kg/day (0.25 mg/L in water) in a study of people in Bangladesh (Rahman et al., 1999), whereas no significant association was found with estimated doses of 0.018 mg As/kg/day (0.75 mg/L in water). Wang et al. (2003) found an increased incidence of microvascular and macrovascular disease among subjects in Taiwan living in an arseniasis-endemic area in which the water of artesian wells had arsenic concentrations >0.35 mg/L (estimated doses of >0.03 mg As/kg/day). An additional study of Taiwanese subjects reported a significant increase in incidence of hypertension associated with concentrations of arsenic in the water >0.7 mg/L (estimated doses of >0.06 mg As/kg/day) (Chen et al., 1995). Studies in Chile indicate that ingestion of 0.6–0.8 ppm arsenic in drinking water (corresponding to doses of 0.02-0.06 mg As/kg/day, depending on age) increases the incidence of Raynaud’s disease and of cyanosis of fingers and toes (Borgoño and Greiber, 1972; Zaldívar, 1974, 1977; Zaldívar and Guillier, 1977). Autopsy of five children from this region who died of apparent arsenic toxicity showed a marked thickening of small and medium sized arteries in tissues throughout the body, especially the heart (Rosenberg, 1974). In addition, cardiac failure, arterial hypotension, myocardial necrosis, and thrombosis have been observed in children who died from chronic arsenic ingestion (Zaldívar, 1974), as well as adults chronically exposed to arsenic (Dueñas et al., 1998). Likewise, thickening and vascular occlusion of blood vessels were noted in German vintners exposed to arsenical pesticides in wine and in adults who drank arsenic-contaminated drinking water (Roth 1957; Zaldívar and Guillier, 1977). A survey of Wisconsin residents using private wells for their drinking water found that residents exposed for at least 20 years to water concentrations of >10μg As/L had increased incidences of cardiac bypass surgery, high blood pressure, and circulatory problems as compared with residents exposed to lower arsenic concentrations (Zierold et al., 2004). Similarly, Lewis et al. (1999) reported increased mortality from hypertensive heart disease in both men and women among a cohort exposed to arsenic in their drinking water in Utah, as compared with the general population of Utah. Limitations in the study included lack of evaluation of smoking as a confounder and of other dietary sources of arsenic, and the lack of a dose-response for hypertensive heart disease. Another ecological study (Engel and Smith 1994) found significant increases in deaths from arteriosclerosis, aortic aneurysm, and all other diseases of the arteries, arterioles, and capillaries among U.S. residents with arsenic drinking waters of >20μg/L; the increase in deaths from congenital anomalies of the heart and other anomalies of the circulatory system also observed in this subpopulation limits the interpretation of the findings (ATSDR, 2007). In a prospective cohort epidemiology study, the risk of young adult mortality due to high chronic exposure to arsenic through years of drinking arsenic-contaminated water was evaluated. 58,406 individuals of 4–18 years at baseline were enrolled and included using Matlab HDSS (Health and Demographic Surveillance System), an active surveillance system. Each individual’s arsenic exposure was calculated at (1) baseline As level as current exposure, (2) time-weighted lifetime exposure (average or lifetime average) and (3) cumulative arsenic exposure. Age, sex, educational attainment and SES were adjusted during the analysis. In this 13-year closed-cohort study (2003–2015), all young-adult deaths were captured through verbal autopsy using International Classification of Diseases (ICD-10) to define the causes. Girls had higher values of cumulative arsenic exposure via tube well water than boys (median: 1858.5 μg/year/L vs. 1798.8 μg/year/L) and higher mortality due to cancers, cardio-vascular disease and respiratory disease. There was a higher risk of death due to all cancers amongst young adults exposed to As > 138.7 µg/L compared to young adults exposed to As ≤ 1.1 μg/L. For cerebro-vascular disease, cardio-vascular disease and respiratory disease deaths, average arsenic in well water (>223.1 μg/L vs. ≤90.9 μg/L) and cumulative arsenic in well water (>2711.0 μg/year/L vs. ≤1013.3 μg/year/L) was linked to a 4.8 (1.8–12.8) and 5.1 (1.7–15.1) times higher risk of mortality than lower exposure. The study concluded that higher concentration of, and chronic exposure to, arsenic in drinking water, increased the mortality risk among the young adults, regardless of gender (Rahman et al., 2019). Gastrointestinal effects: Clinical signs such as gastrointestinal irritation, including nausea, vomiting, diarrhoea and abdominal pain are often observed in individuals with longer-term, low exposure to arsenic (e.g., Borgoño and Greiber, 1972; Cebrián et al., 1983; Franzblau and Lilis, 1989; Guha Mazumder et al., 1988, 1998a; Haupert et al. ,1996; Holland, 1904; Huang et al., 1985; Mizuta et al., 1956; Nagai et al., 1956; Silver and Wainman, 1952; Wagner et al., 1979; Zaldívar, 1974) but effects are usually not detectable at exposure levels below about 0.01 mg As/kg/day (Harrington et al., 1978; Valentine et al., 1985). These symptoms generally decline within a short time after exposure ceases. More severe symptoms (hematemesis, hemoperitoneum, gastrointestinal hemorrhage and necrosis) have been reported in individuals with long-term ingestion of 0.03–0.05 mg As/kg/day as a medicinal preparation (Lander et al., 1975; Morris et al., 1974) (ATSDR, 2007). Haematological effects: Anaemia and leukopenia are common effects of arsenic poisoning in humans and have been reported following intermediate (Franzblau and Lilis, 1989; Heyman et al., 1956; Nagai et al., 1956; Wagner et al., 1979) and chronic oral exposures (Chakraborti et al., 2003a; Glazener et al., 1968; Guha Mazumder et al., 1988; Hopenhayn et al., 2006; Kyle and Pease, 1965; Tay and Seah, 1975) at doses of 0.002 mg As/kg/day or more. These may be due to direct cytotoxic or haemolytic effect on blood cells (Armstrong et al., 1984; Fincher and Koerker, 1987; Goldsmith and From, 1986; Kyle and Pease, 1965; Lerman et al., 1980) and a suppression of erythropoiesis (Kyle and Pease, 1965; Lerman et al., 1980). However, haematological effects are not observed in all cases of arsenic exposure (EPA, 1981b; Harrington et al., 1978; Huang et al., 1985; Silver and Wainman, 1952) (ATSDR, 2007). Hepatic effects: A number of studies in humans exposed to inorganic arsenic by the oral route have noted signs or symptoms of hepatic injury. Clinical examination often revealed that the liver was swollen and tender (Chakraborty and Saha, 1987; Franklin et al., 1950; Guha Mazumder et al., 1988, 1998a; Liu et al., 2002; Mizuta et al., 1956; Silver and Wainman, 1952; Wade and Frazer, 1953; Zaldívar, 1974) and analysis of blood sometimes showed elevated levels of hepatic enzymes (Armstrong et al., 1984; Franzblau and Lilis, 1989; Guha Mazumder, 2005; Hernández-Zavala et al., 1998). These effects are most often observed after repeated exposure to doses of 0.01–0.1 mg As/kg/day (Chakraborty and Saha, 1987; Franklin et al., 1950; Franzblau and Lilis ,1989; Guha Mazumder et al., 1988; Mizuta et al., 1956; Silver and Wainman, 1952; Wade and Frazer, 1953), although doses as low as 0.006 mg As/kg/day have been reported to have an effect following chronic exposure (Hernández-Zavala et al., 1998). Histological examination of the livers of persons chronically exposed to arsenic revealed a consistent finding of portal tract fibrosis (Guha Mazumder, 2005; Guha Mazumder et al., 1988; Morris et al., 1974; Piontek et al., 1989; Szuler et al., 1979), leading in some cases to portal hypertension and bleeding from oesophageal varices (Szuler et al., 1979). Cirrhosis has also been reported at increased frequency in arsenic-exposed individuals (Tsai et al., 1999). Several researchers consider that these hepatic effects are secondary to damage to hepatic blood vessel damage (Morris et al., 1974; Rosenberg, 1974), but this is not directly established (ATSDR, 2007). Dermal effects: One of the most common, characteristic, effects of arsenic ingestion is a pattern of skin changes that include generalized hyperkeratosis and formation of hyperkeratotic warts or corns on the palms and soles, along with areas of hyperpigmentation interspersed with small areas of hypopigmentation on the face, neck and back. These and other dermal effects have been noted in a large majority of human studies involving repeated oral exposure (e.g., Ahmad et al., 1997, 1999b; Ahsan et al., 2000; Bickley and Papa, 1989; Borgoño and Greiber, 1972; Borgoño et al., 1980; Cebrián et al., 1983; Chakraborti et al., 2003a, 2003b; Chakraborty and Saha, 1987; Foyet al., 1992; Franklin et al., 1950; Franzblau and Lilis, 1989; Guha Mazumder et al., 1988, 1998a, 1998b, 1998c; Guo et al., 2001a; Haupert et al., 1996; Huang et al., 1985; Lander et al., 1975; Liu et al., 2002; Lüchtrath, 1983; Milton et al., 2004; Mizuta et al., 1956; Morris et al., 1974; Nagai et al., 1956; Piontek et al., 1989; Rosenberg, 1974; Saha and Poddar, 1986; Silver and Wainman, 1952; Szuler et al., 1979; Tay and Seah, 1975; Tseng et al., 1968; Wade and Frazer, 1953; Wagner et al., 1979; Wong et al., 1998a, 1998b; Zaldívar, 1974, 1977). In cases of low-level chronic exposure (usually from water), these skin lesions appear to be the most sensitive indication of exposure, so this endpoint is considered to be the most appropriate basis for establishing a chronic oral MRL. This is supported by the finding that other effects (hepatic injury, vascular disease and neurological changes) also appear to have similar thresholds. Numerous studies in humans have reported dermal effects at chronic dose levels generally ranging from about 0.01-0.1 mg As/kg/day (Ahmad et al., 1997; Bickley and Papa, 1989; Borgoño and Greiber, 1972; Borgoño et al., 1980; Cebrián et al., 1983; Chakraborty and Saha, 1987; Foy et al., 1992; Franklin et al., 1950; Guha Mazumder et al., 1988; Huang et al., 1985; Lüchtrath, 1983; Piontek et al., 1989; Silver and Wainman, 1952; Tseng et al., 1968; Zaldívar, 1974, 1977). However, in a study with detailed exposure assessment, all confirmed cases of skin lesions occurred following ingested water containing >100μg/L arsenic (approximately 0.0037 mg As/kg/day) and the lowest known peak arsenic concentration ingested by a case was 0.115μg/L (approximately 0.0043 mg As/kg/day) (Haque et al., 2003). Another large study reported increased incidence of skin lesions associated with estimated doses of 0.0012 mg As/kg/day (0.023 mg As/L drinking water) (Ahsan et al., 2006). Several epidemiological studies of moderately sized populations (20–200 people) exposed to arsenic through drinking water detected no dermal or other effects at average chronic doses of 0.0004–0.01 mg As/kg/day (Cebrián et al., 1983; EPA, 1981b; Guha Mazumder et al., 1988; Harrington et al., 1978; Valentine et al., 1985) and one very large study detected no effects at an average total daily intake (from water plus food) of 0.0008 mg As/kg/day (Tseng et al., 1968). Neurological effects: A large number of epidemiological studies and case reports indicate that ingestion of inorganic arsenic can cause injury to the nervous system. Repeated exposure to low levels (0.03–0.1 mg As/kg/day) is typically characterised by a symmetrical peripheral neuropathy (Chakraborti et al., 2003a, 2003b; Foy et al., 1992; Franzblau and Lilis, 1989; Guha Mazumder et al., 1988; Hindmarsh et al., 1977; Huang et al., 1985; Lewis et al., 1999; Mizuta et al., 1956; Muzi et al., 2001; Silver and Wainman, 1952; Szuler et al., 1979; Wagner et al., 1979). Neurological effects were not generally found in populations chronically exposed to doses of 0.006 mg As/kg/day or less (EPA 1981b; Harrington et al., 1978; Hindmarsh et al., 1977). There is emerging evidence suggesting that exposure to arsenic may be associated with intellectual deficits in children. For example, Wasserman et al. (2004) conducted a cross-sectional evaluation of intellectual function in 201 children, 10 years of age, whose parents were part of a larger cohort in Bangladesh. After adjustment for confounding factors, a dose-related inverse effect of arsenic exposure was seen on both performance and Full-Scale subset scores. For both endpoints, exposure to ≥50μg/L resulted in statistically significant differences (p<0.05) relative to the lowest exposure group (<5.5μg/L). A study of 351 children age 5–15 years from West Bengal, India, found significant associations between urinary arsenic concentrations and reductions in scores of tests of vocabulary, object assembly and picture completion. The magnitude of the reductions varied between 12 and 21% (von Ehrenstein et al., 2007). In this cohort, the average lifetime peak arsenic concentration in well water was 0.147 mg/L. However, no clear pattern was found for increasing categories of peak arsenic water concentrations since birth and children’s scores in the various neurobehavioral tests conducted. Furthermore, using peak arsenic as a continuous variable in the regression models also did not support an adverse effect on the tests results (ATSDR, 2007). Renal effects: Most case studies of chronic arsenic toxicity do not report clinical signs of significant renal injury, even when other systems are severely impaired (e.g., Cullen et al. 1995; Franzblau and Lilis, 1989; Jenkins, 1966; Kersjes et al., 1987; Mizuta et al., 1956; Silver and Wainman, 1952) (ATSDR, 2007). Other organ systems: No reliable studies of musculoskeletal or immunological effects in humans after oral exposure to inorganic arsenicals have been reported (ATSDR, 2007). Effects in animals Respiratory effects: There are only few data regarding respiratory effects in animals following oral exposure to inorganic arsenic. An infant Rhesus monkey that died after 7 days of oral exposure to a complex arsenate salt at a dose of 3 mg As/kg/day exhibited bronchopneumonia with extensive pulmonary haemorrhage, oedema and necrosis (Heywood and Sortwell, 1979). Two other monkeys in this treatment group survived a 1-year exposure period and had no gross or microscopic pulmonary lesions at sacrifice. Increased relative lung weights were seen in rats exposed to 6.66 mg As/kg/day as sodium arsenite 5 days/week for 12 weeks (Schulz et al., 2002). Chronic oral studies in dogs and rats treated with arsenate or arsenite failed to find respiratory lesions (Byron et al., 1967; Kroes et al., 1974; Schroeder et al., 1968) (ATSDR, 2007). Cardiovascular effects: Alterations in vascular reactivity was noted in rats given repeated oral doses of arsenic trioxide (11 mg As/kg/day) for several weeks (Bekemeier and Hirschelmann, 1989), although no histological effects could be detected in the hearts of rats or dogs exposed to up to 30 mg As/kg/day as arsenate or arsenite for 2 years (Byron et al., 1967; Kroes et al., 1974; Schroeder et al., 1968). Guinea pigs exposed to arsenic trioxide for 1 day (0, 7.6, 22.7, or 37.9 mg As/kg) or 8 days (0 or 3.8 mg As/kg/day) showed prolongation of the cardiac QT interval and action potential duration (Chiang et al., 2002) (ATSDR, 2007). Gastrointestinal effects: Clinical signs of gastrointestinal irritation were observed in monkeys and rats given repeated oral doses of arsenic (6 and 11 mg As/kg/day, respectively) for 2 weeks (Bekemeier and Hirschelmann, 1989; Heywood and Sortwell, 1979). Hemorrhagic gastrointestinal lesions have also been reported in animal studies. A monkey that died after repeated oral treatment with 6 mg As/kg/day for approximately 1 month was found to have acute inflammation and hemorrhage of the small intestine upon necropsy (Heywood and Sortwell, 1979). This lesion was not found in other monkeys that died in this study, or in the survivors. Two pregnant mice that died after repeated gavage treatment with 24 mg As/kg/day as arsenic acid had haemorrhagic lesions in the stomach (Nemec et al., 1998). Gross gastrointestinal lesions (stomach adhesions, eroded luminal epithelium in the stomach) were seen frequently in rats treated by gavage with 8 mg As/kg/day as arsenic trioxide starting before mating and continuing through the end of gestation (Holson et al., 2000). The lesions were not found in rats treated with 4 mg As/kg/day in this study. No histological evidence of gastrointestinal injury was detected in rats exposed to arsenate or arsenite in the feed for 2 years at doses up to 30 mg As/kg/day, but dogs fed a diet containing 2.4 mg As/kg/day as arsenite for 2 years had some bleeding in the gut (Byron et al., 1967; Kroes et al. 1974) (ATSDR, 2007). Haematological effects: Long-term studies found mild anaemia in dogs fed arsenite or arsenate for 2 years at 2.4 mg As/kg/day, but no haematological effect in dogs fed 1 mg As/kg/day for 2 years or 1.9 mg As/kg/day for 26 weeks (Byron et al., 1967; Neiger and Osweiler, 1989). Chronic rat studies found little or no evidence of anaemia at doses up to 30 mg As/kg/day, even with co-exposure to lead (Byron et al., 1967; Kroes et al., 1974). No haematological effects were found in monkeys exposed to arsenic doses of 3–6 mg As/kg/day for 1 year (Heywood and Sortwell, 1979).Exposure of rats to ≥5 ppm of arsenic (0.30 mg As/kg/day as sodium arsenite) in the drinking water for 4 weeks resulted in increased platelet aggregation, while 10 or 25 ppm (0.60 or 1.5 mg As/kg/day) was associated with increased P-selectin-positive cells and decreased occlusion time (Lee et al. 2002), representing a change in platelet function. Similarly, exposure of rats or guinea pigs to 10 or 25 ppm of arsenic as arsenite (approximate doses of 0, 0.92, or 2.3 mg As/kg/day for rats and 0, 0.69, or 1.7 mg As/kg/day for guinea pigs) in the drinking water for 16 weeks (Kannan et al. 2001) resulted in decreases in erythrocyte and leukocyte numbers (rats and guinea pigs), increased blood mean corpuscular volume and corpuscular haemoglobin mass (guinea pigs only), and decreased mean corpuscular haemoglobin concentration (rats only) (ATSDR, 2007). Hepatic effects: Studies in dogs or mice have not detected clinically significant hepatic injury following exposure to either arsenite or arsenate (Byron et al., 1967; Fowler and Woods, 1979; Kerkvliet et al., 1980; Neiger and Osweiler, 1989; Schroeder and Balassa, 1967), although enlargement of the common bile duct was noted in rats fed either arsenate or arsenite in the diet for 2 years (Byron et al., 1967; Kroes et al., 1974) and lipid vacuolation and fibrosis were seen in the livers of rats exposed to 12 mg As/kg/day as arsenate in the drinking water for 6 weeks (Fowler et al., 1977). Similarly, fatty changes and inflammatory cell infiltration were seen in the livers of both normal and metallothionein-null mice exposed to 5.6 mg arsenic/kg/day in the drinking water for 48 weeks (Liu et al., 2000). An increase in indices of peroxidation was reported in rats dosed with approximately 0.02 mg As/kg/day for 60 days from drinking water containing 2.5 mg sodium arsenite/L (Bashir et al., 2006); absolute liver weight was also increased at this dose level. Exposure of guinea pigs to 0.69 or 1.7 mg As/kg/day in the drinking water for 16 weeks, but not in rats exposed to 0.92 or 2.3 mg As/kg/day, resulted in increases in delta-aminolaevulinic acid synthetase (ALAS) levels (Kannan et al., 2001). Exposure of BALB/C mice to 0.7 mg arsenic/kg/day in the drinking water for 15 months resulted in increased liver weights, changes in liver enzymes (glutathione S-transferase, glutathione reductase, catalase, glucose-6-phosphate dehydrogenase, glutathione peroxidase), fatty liver, and fibrosis (Santra et al., 2000) (ATSDR, 2007). Dermal effects: Dermal lesions similar to those observed in humans have not been noted in oral exposure studies in monkeys (Heywood and Sortwell, 1979), dogs (Byron et al., 1967) or rodents (Schroeder et al., 1968) (ATSDR, 2007). Neurological effects: Neurological effects have been observed in animal studies. Rodriguez et al. (2001) evaluated neurobehavioral changes in male Sprague-Dawley rats exposed to 0, 5, 10 or 20 mg As/kg/day as sodium arsenite by gavage for 2 or 4 weeks. Significant effects were seen in spontaneous locomotor activity and the food pellet manipulation test in the high-dose animals, while no effects were seen in the low- or mid-dose rats. Decreased performance in open field tests were also seen in rats exposed to 26.6 mg As/kg/day, but not to 13.3 mg/kg/day or less, as sodium arsenite for 4 weeks (Schulz et al., 2002). Curiously, the behavioural changes were no longer present at 8 and 12 weeks of exposure, which may suggest an adaptive response. Heywood and Sortwell (1979) reported salivation and uncontrolled head shaking in two monkeys given several doses of 6 mg As/kg/day as arsenate, while no such effects were noted in monkeys given 3 mg As/kg/day for 2 weeks. Nemec et al. (1998) observed ataxia and prostration in pregnant female rabbits treated with 1.5 mg As/kg/day repeatedly during gestation, but not in rabbits treated with 0.4 mg As/kg/day (ATSDR, 2007). In a subacute oral toxicity study in rats, arsenic and fluoride exposure on motor behavior and general toxicity were modelled in young adult male rats which received sodium (meta) arsenite (10 mg/kg bw), sodium fluoride (5 mg/kg bw), and their combination by gavage, once daily, 5 days a week for 6 weeks. After 6 weeks, 6 animals per group were dissected, while the other 6 were kept for 6 more weeks untreated. Body weight, together with food and water consumption, was measured daily. Arsenic, alone or along with fluoride, caused significant decrease in rearing, and increase in immobility and local activity in the open field in the 3rd and 6th week. By the 12th week, these changes mostly diminished. Weight gain, and food and water consumption were significantly reduced by arsenic but normalized post treatment. Fluoride had no own effect and mostly no influence on effects of arsenic. Massive deposition of arsenic in the rats’ blood, cerebral cortex, and liver by the 6th week, and partial elimination by the 12th week, was seen. The study author concluded that the results underline the risk of neuro-functional damage by arsenic and called for further investigations (Sárközi et al., 2015). Reproductive organ effects: A study was conducted to determine the sub-chronic exposure effect of sodium arsenite on reproductive organs of female Wistar rats. Mature female rats were divided into 4 groups of 12 animals each. Group I received distilled water, whereas the other 3 groups received sodium arsenite at 10, 30, and 50 µg/L doses for 60 days through drinking water. Half of the animals from each group were dissected after 30 days and the remaining after 60 days. A disruption in estrous cycle was observed with prolonged diestrous and metestrous phases. A significant increase in ovarian surface epithelium and follicular atresia was observed in treated rats (p ≤ 0.05). A significant decrease (p ≤ 0.05) in the uterine myometrium was observed. A significant increase (p ≤ 0.05) in the levels of lipid peroxidation along with decrease in the activities of antioxidant enzymes was observed. The study author based on the results concluded that the sub-chronic exposure to sodium arsenite causes degenerative changes in reproductive organs and induces oxidative stress in female rats (Mehta et al., 2016). In a subacute toxicity study in mice, the effects of As2O3 on sperm and testicular morphology, androgen receptor (AR) immunoreactivity in testes and epididymis, in addition to evaluation of fertility parameters in adult male mice were determined. 30 adult Swiss mice were divided into three experimental groups: control; received distilled water (vehicle) while treated received 0.3 or 3 mg/kg/day As2O3 subcutaneously, for 5 days per week, followed by 2 days of interruption, for 5 weeks. Results showed that As2O3 (1) decreased spermatozoa number, (2) produced seminiferous epithelium degeneration and exfoliation of germ cells tubule lumen (3) altered nucleus/cytoplasm proportion of Leydig cells and (4) reduced AR immunoreactivity in both Leydig and epithelial epididymal cells. Further, fetal viability tests demonstrated an increase in post-implantation loss in females that were mated with As2O3-treated males. Data indicate that As2O3 exposure altered the spermatogenic process and subsequently fetal viability (Da Silva et al., 2017). Other organ systems: No reliable studies of musculoskeletal or immunological effects in humans after oral exposure to inorganic arsenicals have been reported (ATSDR, 2007). Studies in animals also indicate that the kidney is not a major target organ for inorganic arsenic (Byron et al., 1967; Schroeder and Balassa, 1967; Woods and Southern, 1989) (ATSDR, 2007). Mode of action The mechanism by which inorganic arsenic produces its effects in various organs and systems is not entirely elucidated. There is growing evidence for a mode of action involving the formation of reactive trivalent metabolites interacting with critical cell sulfhydryl groups, leading to cytotoxicity and regenerative cell proliferation. The cytotoxicity results in non-cancer toxicities and the cell proliferation enhances the development of epithelial cancers (see section on Carcinogenicity). In other tissues such as vascular endothelium, different toxicities develop, not cancer (Cohen et al., 2013). References not cited in ATSDR (2007) Cohen SM et al. (2013). Evaluation of the carcinogenicity of inorganic arsenic. Crit. Rev. Toxicol. 43(9):711-752. Ghosh A (2013). Evaluation of chronic arsenic poisoning due to consumption of contaminated ground water in West Bengal, India. Int. J. Prev. Med. 4(8):976-9. Das D et al. (2014). Chronic low-level arsenic exposure reduces lung function in male population without skin lesions. Int. J. Public Health 59(4):655-63. Sárközi K et al. (2015). Behavioral and general effects of subacute oral arsenic exposure in rats with and without fluoride. Int. J. Environ. Health. Res. 25(4):418-31. Mehta M and Hundal SS (2016). Effect of sodium arsenite on reproductive organs of female Wistar rats. Arch. Environ. Occup. Health. 71(1):16-25. Moon KA et al. (2013). Association between exposure to low to moderate arsenic levels and incident cardiovascular disease. Annals Int. Med. http://annals.org. Da Silva RF et al.(2017). Arsenic trioxide exposure impairs testicular morphology in adult male mice and consequent fetus viability. J. Toxicol. Environ. Health A. 80 (19-21):1166-1179. Rahman M et al. (2019). Arsenic exposure and young adult’s mortality risk: a 13-year follow-up study in Matlab, Bangladesh. Environ. Int. 123:358-367. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/104a4e33-e910-49c5-a114-50666e771ff8/documents/c5923866-7a1a-4b61-89cf-00efac4b219e_0b0f8eaf-08c0-46d1-a41c-36099d438aad.html,,,,,, Arsenic,7440-38-2," The following information is taken into account for any hazard / risk assessment: The acute toxicity of arsenic compounds has been studied to great extent in animal studies and there are also many case reports of acute effects in humans. The focus of such investigations has been on oral exposure. Because of the enormous amount of data, reference is made to available reviews, su h as the “Toxicological Profile for Arsenic (ATSDR, 2007), or to peer-reviewed factual databases, such as the Hazardous Substance Databank (HSDB) and the Registry of Toxic Effects of Chemical Substances (RTECS). For arsenic, reported oral LD50s in animals are in the range from ca. 144-763 mg/kg, which is in agreement with the existing harmonized classification as “Acute Tox 3” according to Regulation (EC) No 1272/2008. Experimental investigations on acute inhalation toxicity are not available for arsenic metal and a reliable standard toxicity descriptor value, such as a LC50(4h), cannot be established for arsenic. Arsenice metal is produced and marketed mainly in granular form (only ca. 10 kg/year in powder form). Such granules cannot be inhlaed, which renders testing for inhalation toxicity technically unfeasible. In addition, because of the carcinogenicity potential (self-classification), strict measures are alreday in place to exclude or minimise as far as possible any exposure of humans to such compounds. Adverse effects from dermal exposure to inorganic or organic arsenicals have not been extensively investigated. No studies were located regarding death in humans after dermal exposure to inorganic arsenicals. In rats, no deaths resulted from dermal exposure to arsenate or arsenite at doses up to 1,000 mg As/kg (e.g. Gaines, 1960). These data indicate that dermal exposure to inorganic arsenic compounds is unlikely to result in lethality. The chemical nature of arsenic metal, together with its poor solubility, renders its potential for uptake though skin low. This is also the case for any expected transformation/dissolution products, i.e. dissolved arsenic in ionic form. Uptake of arsenic through the skin has been determined to occur at rates below 2%, when applied in dissolved form as radiolabelled arsenic acid to human skin in vitro (Wester et al., 1993).With regards to this low dermal absorption, we can consider this route of exposure to be of limited relevance. Due to the well-known toxicological profile of arsenic compounds and specifically because of the existing harmonised classification for acute toxicity via the oral and inhalation route (H301 and H331) and for animal welfare reasons, it is not justified to conduct further toxicological studies in experimental animals. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/104a4e33-e910-49c5-a114-50666e771ff8/documents/IUC5-f24f3ce9-ab10-4edf-87e7-c18e0367f891_0b0f8eaf-08c0-46d1-a41c-36099d438aad.html,,,,,, Arsenic,7440-38-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/104a4e33-e910-49c5-a114-50666e771ff8/documents/IUC5-f24f3ce9-ab10-4edf-87e7-c18e0367f891_0b0f8eaf-08c0-46d1-a41c-36099d438aad.html,,oral,LD50,144 mg/kg bw,adverse effect observed, 4-phenylbutenone,122-57-6," 1) Japan MHLW, 2011, rats, oral, 28 days, NOAEL 60 mg/kg bw for males and females 2) NTP, 2012a, rats, oral, 3 month, NOAEL 145 mg/kg bw for females and 150 mg/kg bw for males 3) NTP, 2012a, mice, oral, 3 month, NOAEL 350 mg/kg bw for females and 400 mg/kg bw for males 4) NTP, 2012a, rats, dermal, 3 month, NOAEL 87.5 mg/kg bw for males and females 5) NTP, 2012a, mice, dermal, 3 month, LOAEL 87.5 mg/kg bw for males and females ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/006d2672-b499-4875-b0e2-6aa1530de5ce/documents/IUC5-c68da5cf-ac59-44f7-84b4-68d1b803c551_c255030d-6529-4344-b987-83b21de6fb87.html,,,,,, 4-phenylbutenone,122-57-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/006d2672-b499-4875-b0e2-6aa1530de5ce/documents/IUC5-c68da5cf-ac59-44f7-84b4-68d1b803c551_c255030d-6529-4344-b987-83b21de6fb87.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,145 mg/kg bw/day,,rat 4-phenylbutenone,122-57-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/006d2672-b499-4875-b0e2-6aa1530de5ce/documents/IUC5-c68da5cf-ac59-44f7-84b4-68d1b803c551_c255030d-6529-4344-b987-83b21de6fb87.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,87.5 mg/kg bw/day,,rat 4-phenylbutenone,122-57-6," Acute toxicity oral: publication and GESTIS Database; LD50(rat) = 2030 mg/kg; LD50 (rat) = > 5000 mg/kg Acute toxicity dermal: publication, LD50 (rabbit) = > 3000 mg/kg ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/006d2672-b499-4875-b0e2-6aa1530de5ce/documents/IUC5-d7d525e2-d974-4a25-b0f6-a0dc66015586_c255030d-6529-4344-b987-83b21de6fb87.html,,,,,, 4-phenylbutenone,122-57-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/006d2672-b499-4875-b0e2-6aa1530de5ce/documents/IUC5-d7d525e2-d974-4a25-b0f6-a0dc66015586_c255030d-6529-4344-b987-83b21de6fb87.html,,oral,LD50,"2,030 mg/kg bw",no adverse effect observed, 4-phenylbutenone,122-57-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/006d2672-b499-4875-b0e2-6aa1530de5ce/documents/IUC5-d7d525e2-d974-4a25-b0f6-a0dc66015586_c255030d-6529-4344-b987-83b21de6fb87.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, chloromethane; methyl chloride,74-87-3,"NOAEC systemic (rat and mouse, 2 a): 465 mg/m³ (CIIT, 1981) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d91defcf-1e94-40c7-81f9-cf5423033af7/documents/IUC5-38c22464-0bfd-4538-addf-bd40f9ddaea7_37d12ebb-943e-40dd-a020-224a4fabd1e5.html,,,,,, chloromethane; methyl chloride,74-87-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d91defcf-1e94-40c7-81f9-cf5423033af7/documents/IUC5-38c22464-0bfd-4538-addf-bd40f9ddaea7_37d12ebb-943e-40dd-a020-224a4fabd1e5.html,Chronic toxicity – systemic effects,inhalation,NOAEC,465 mg/m3,, chloromethane; methyl chloride,74-87-3,"Inhalation: LC50 (rat) > 21.8 mg/L (10557 ppm) (Griffith and Watson, 2009) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d91defcf-1e94-40c7-81f9-cf5423033af7/documents/IUC5-a506c62a-c2aa-4803-9b00-fd73f8dd3ef7_37d12ebb-943e-40dd-a020-224a4fabd1e5.html,,,,,, chloromethane; methyl chloride,74-87-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d91defcf-1e94-40c7-81f9-cf5423033af7/documents/IUC5-a506c62a-c2aa-4803-9b00-fd73f8dd3ef7_37d12ebb-943e-40dd-a020-224a4fabd1e5.html,,inhalation,LC50,"21,800 mg/m3",no adverse effect observed, "Distillates (petroleum), solvent-dewaxed light paraffinic",64742-56-9,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93852073-a0bd-4f95-8bf6-fa2772360221/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_2a5c4a2c-6172-4d00-9e07-ab40bc411498.html,,,,,, "Distillates (petroleum), solvent-dewaxed light paraffinic",64742-56-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93852073-a0bd-4f95-8bf6-fa2772360221/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_2a5c4a2c-6172-4d00-9e07-ab40bc411498.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Distillates (petroleum), solvent-dewaxed light paraffinic",64742-56-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93852073-a0bd-4f95-8bf6-fa2772360221/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_2a5c4a2c-6172-4d00-9e07-ab40bc411498.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Distillates (petroleum), solvent-dewaxed light paraffinic",64742-56-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93852073-a0bd-4f95-8bf6-fa2772360221/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_2a5c4a2c-6172-4d00-9e07-ab40bc411498.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Distillates (petroleum), solvent-dewaxed light paraffinic",64742-56-9,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93852073-a0bd-4f95-8bf6-fa2772360221/documents/73761dae-46d6-428e-8e40-e5cc70088d96_2a5c4a2c-6172-4d00-9e07-ab40bc411498.html,,,,,, "Distillates (petroleum), solvent-dewaxed light paraffinic",64742-56-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93852073-a0bd-4f95-8bf6-fa2772360221/documents/73761dae-46d6-428e-8e40-e5cc70088d96_2a5c4a2c-6172-4d00-9e07-ab40bc411498.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), solvent-dewaxed light paraffinic",64742-56-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93852073-a0bd-4f95-8bf6-fa2772360221/documents/73761dae-46d6-428e-8e40-e5cc70088d96_2a5c4a2c-6172-4d00-9e07-ab40bc411498.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), solvent-dewaxed light paraffinic",64742-56-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93852073-a0bd-4f95-8bf6-fa2772360221/documents/73761dae-46d6-428e-8e40-e5cc70088d96_2a5c4a2c-6172-4d00-9e07-ab40bc411498.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Slack wax (petroleum),64742-61-6,"No oral repeat dose toxicity data are available for slack waxes (non-carcinogenic feed-stock). Data are available on similar materials (Paraffin waxes) to adequately characterize the repeated dose toxicity of slack waxes (Non-carcinogenic feed-stock). The data are consistent in that they demonstrate that paraffin and hydrocarbon waxes were found to be of low acute toxicity by the oral route.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for slack waxes (carcinogenic or unknown feed-stock) using read-across to a 90-day subchronic toxicity study that tested untreated distillate aromatic extracts. For dermal repeat dose toxicity, data are available on similar materials to adequately characterize the repeated dose toxicity of  slack waxes (carcinogenic or unknown feed-stock and non-carcinogenic feed-stock). The data are consistent in that they demonstrate minimal effects in rabbits with the exception of minimal to moderate skin irritation following repeated dermal exposures. For inhalation repeat dose toxicity, no data are available on slack waxes.  However, inhalation exposure to slack waxes is not expected to occur under normal conditions due to the very low vapour pressures of these substances. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70b5fc0d-e88b-4c82-926b-9889132c1dcd/documents/bfab73c8-6f6d-4fd7-9346-ff1bf3d1b7c2_9c3cbb3a-d2e6-478f-9b4a-329ccb9d9bdb.html,,,,,, Slack wax (petroleum),64742-61-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70b5fc0d-e88b-4c82-926b-9889132c1dcd/documents/bfab73c8-6f6d-4fd7-9346-ff1bf3d1b7c2_9c3cbb3a-d2e6-478f-9b4a-329ccb9d9bdb.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat Slack wax (petroleum),64742-61-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70b5fc0d-e88b-4c82-926b-9889132c1dcd/documents/bfab73c8-6f6d-4fd7-9346-ff1bf3d1b7c2_9c3cbb3a-d2e6-478f-9b4a-329ccb9d9bdb.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse Slack wax (petroleum),64742-61-6,Read-across toxicity studies for acute oral (OECD 401) and dermal (OECD 402) toxicity  were identified for slack waxes (carcinogenic or unknown feed-stock and non-carcinogenic feedstock).  No acute inhalation toxicity studieshave been reported for slack waxes since inhalation exposure is not expected to occur under normal conditions due to the very low vapour pressures of these substances. LD50 values were as follows:• The oral LD50 was > 5000 mg/kg bw in male and female rats.• The dermal LD50 was > 2000 or 5000 mg/kg bw in male and female rabbits. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70b5fc0d-e88b-4c82-926b-9889132c1dcd/documents/d768da8b-e789-4187-9286-e7a5f3f89a50_9c3cbb3a-d2e6-478f-9b4a-329ccb9d9bdb.html,,,,,, Slack wax (petroleum),64742-61-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70b5fc0d-e88b-4c82-926b-9889132c1dcd/documents/d768da8b-e789-4187-9286-e7a5f3f89a50_9c3cbb3a-d2e6-478f-9b4a-329ccb9d9bdb.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Slack wax (petroleum),64742-61-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70b5fc0d-e88b-4c82-926b-9889132c1dcd/documents/d768da8b-e789-4187-9286-e7a5f3f89a50_9c3cbb3a-d2e6-478f-9b4a-329ccb9d9bdb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), heavy vacuum",64741-57-7," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/87eb257d-7687-49b1-82dc-5087405719d3/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_dcd87a71-0190-4455-9c14-dae21ef4389b.html,,,,,, "Gas oils (petroleum), heavy vacuum",64741-57-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/87eb257d-7687-49b1-82dc-5087405719d3/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_dcd87a71-0190-4455-9c14-dae21ef4389b.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Gas oils (petroleum), heavy vacuum",64741-57-7,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87eb257d-7687-49b1-82dc-5087405719d3/documents/12190120-6b6e-49c5-bed7-264eab246437_dcd87a71-0190-4455-9c14-dae21ef4389b.html,,,,,, "Gas oils (petroleum), heavy vacuum",64741-57-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87eb257d-7687-49b1-82dc-5087405719d3/documents/12190120-6b6e-49c5-bed7-264eab246437_dcd87a71-0190-4455-9c14-dae21ef4389b.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), heavy vacuum",64741-57-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87eb257d-7687-49b1-82dc-5087405719d3/documents/12190120-6b6e-49c5-bed7-264eab246437_dcd87a71-0190-4455-9c14-dae21ef4389b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), heavy vacuum",64741-57-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87eb257d-7687-49b1-82dc-5087405719d3/documents/12190120-6b6e-49c5-bed7-264eab246437_dcd87a71-0190-4455-9c14-dae21ef4389b.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, m-tolylidene diisocyanate,26471-62-5," Oral: In a subacute oral repeated dose toxicity study in Crj: CD(SD) rats with m-tolylidene diisocyanate similar to Guideline for 28 day Repeated Dose Toxicity in Mammalian Species (Chemical Substances Control Law of Japan) a LOAEL of 30 mg/kg bw was determined (Ministry of Health Labour Welfare Japan, 2001). Inhalation: In a combined chronic toxicity and carcinogenicity study similar to OECD Guideline 453, CD-1 mice were exposed to m-tolylidene diisocyanate (80/20) (Owen, 1986). A LOAEC of 0.05 ppm was determined. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da8e4260-3b5d-4f7b-9b81-062f483af5ed/documents/IUC5-678e94af-0ecf-4450-b59d-895eabff1ab0_af97cd5f-6cba-4c73-bead-bcbd58bce6c9.html,,,,,, m-tolylidene diisocyanate,26471-62-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da8e4260-3b5d-4f7b-9b81-062f483af5ed/documents/IUC5-678e94af-0ecf-4450-b59d-895eabff1ab0_af97cd5f-6cba-4c73-bead-bcbd58bce6c9.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,30 mg/kg bw/day,,rat m-tolylidene diisocyanate,26471-62-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da8e4260-3b5d-4f7b-9b81-062f483af5ed/documents/IUC5-678e94af-0ecf-4450-b59d-895eabff1ab0_af97cd5f-6cba-4c73-bead-bcbd58bce6c9.html,Chronic toxicity – systemic effects,inhalation,LOAEC,0.362 mg/m3,,mouse m-tolylidene diisocyanate,26471-62-5," Acute toxicity: oral In an NTP study similar to OECD Guideline 401 with rats and mice (NTP, 1986), an LD50 > 2000 mg/kg bw was determined. Acute toxicity: dermal In a dermal acute toxicity study according to OECD Guideline 402 in rabbits (Wazeter, 1964), an LD50 > 2000 mg/kg was determined. Acute toxicity: inhalation In an inhalation study according to OECD Guideline 403 in rats (Doe/Horspool, 1980), an LC50 = 0.48 mg/L was determined. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da8e4260-3b5d-4f7b-9b81-062f483af5ed/documents/IUC5-d7f9cfa5-e231-4cd6-8066-ed10edd15414_af97cd5f-6cba-4c73-bead-bcbd58bce6c9.html,,,,,, m-tolylidene diisocyanate,26471-62-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da8e4260-3b5d-4f7b-9b81-062f483af5ed/documents/IUC5-d7f9cfa5-e231-4cd6-8066-ed10edd15414_af97cd5f-6cba-4c73-bead-bcbd58bce6c9.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, m-tolylidene diisocyanate,26471-62-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da8e4260-3b5d-4f7b-9b81-062f483af5ed/documents/IUC5-d7f9cfa5-e231-4cd6-8066-ed10edd15414_af97cd5f-6cba-4c73-bead-bcbd58bce6c9.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, m-tolylidene diisocyanate,26471-62-5,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da8e4260-3b5d-4f7b-9b81-062f483af5ed/documents/IUC5-d7f9cfa5-e231-4cd6-8066-ed10edd15414_af97cd5f-6cba-4c73-bead-bcbd58bce6c9.html,,inhalation,LC50,0.48 ,adverse effect observed, "Gases (petroleum), catalytic cracked overheads",68409-99-4,"After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and in humans. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9728a169-da2b-4e4b-b496-feb672b2245d/documents/c056898b-bfcd-467a-81f5-932d319271c5_18a87b9f-6b65-46bd-beb1-c1fe9f6d14fd.html,,,,,, "Gases (petroleum), catalytic cracked overheads",68409-99-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9728a169-da2b-4e4b-b496-feb672b2245d/documents/c056898b-bfcd-467a-81f5-932d319271c5_18a87b9f-6b65-46bd-beb1-c1fe9f6d14fd.html,Chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Gases (petroleum), catalytic cracked overheads",68409-99-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9728a169-da2b-4e4b-b496-feb672b2245d/documents/c056898b-bfcd-467a-81f5-932d319271c5_18a87b9f-6b65-46bd-beb1-c1fe9f6d14fd.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human (epidemiological findings) "Gases (petroleum), catalytic cracked overheads",68409-99-4," Benzene does not pose an acute hazard following ingestion (oral LD50 > 2000 mg/kg), skin contact (dermal LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9728a169-da2b-4e4b-b496-feb672b2245d/documents/d5c4a791-dd55-400f-823a-3a66c0f7cf91_18a87b9f-6b65-46bd-beb1-c1fe9f6d14fd.html,,,,,, "Gases (petroleum), catalytic cracked overheads",68409-99-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9728a169-da2b-4e4b-b496-feb672b2245d/documents/d5c4a791-dd55-400f-823a-3a66c0f7cf91_18a87b9f-6b65-46bd-beb1-c1fe9f6d14fd.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gases (petroleum), catalytic cracked overheads",68409-99-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9728a169-da2b-4e4b-b496-feb672b2245d/documents/d5c4a791-dd55-400f-823a-3a66c0f7cf91_18a87b9f-6b65-46bd-beb1-c1fe9f6d14fd.html,,dermal,LD50,"8,260 mg/kg bw",no adverse effect observed, "Gases (petroleum), catalytic cracked overheads",68409-99-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9728a169-da2b-4e4b-b496-feb672b2245d/documents/d5c4a791-dd55-400f-823a-3a66c0f7cf91_18a87b9f-6b65-46bd-beb1-c1fe9f6d14fd.html,,inhalation,LC50,"43,767 mg/m3",no adverse effect observed, "α,α,α,4-tetrachlorotoluene",5216-25-1, Acute oral toxicity LD50 = 572 mg/ kg bw/ day for both sexes Acute inhalation toxicity LC50 (4 hour) = 1.43 g/m3 (corresponding to 1.43 mg/l) of air ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f76067b7-d2bb-4530-bef0-e52dbcfeebce/documents/IUC5-0989a90b-27b1-40ea-acc4-4f5413b648f4_32713c39-c02a-457f-a1f9-c1a595f6b569.html,,,,,, "α,α,α,4-tetrachlorotoluene",5216-25-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f76067b7-d2bb-4530-bef0-e52dbcfeebce/documents/IUC5-0989a90b-27b1-40ea-acc4-4f5413b648f4_32713c39-c02a-457f-a1f9-c1a595f6b569.html,,oral,LD50,572 mg/kg bw,adverse effect observed, "α,α,α,4-tetrachlorotoluene",5216-25-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f76067b7-d2bb-4530-bef0-e52dbcfeebce/documents/IUC5-0989a90b-27b1-40ea-acc4-4f5413b648f4_32713c39-c02a-457f-a1f9-c1a595f6b569.html,,inhalation,LC50,"1,430 mg/m3",adverse effect observed, "Residues (petroleum), thermal cracked",64741-80-6," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b0cd87f-bc12-4352-b5a9-129f164f5bb6/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_94f85476-aed9-4c48-8ee1-14199f614a13.html,,,,,, "Residues (petroleum), thermal cracked",64741-80-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b0cd87f-bc12-4352-b5a9-129f164f5bb6/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_94f85476-aed9-4c48-8ee1-14199f614a13.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Residues (petroleum), thermal cracked",64741-80-6,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b0cd87f-bc12-4352-b5a9-129f164f5bb6/documents/12190120-6b6e-49c5-bed7-264eab246437_94f85476-aed9-4c48-8ee1-14199f614a13.html,,,,,, "Residues (petroleum), thermal cracked",64741-80-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b0cd87f-bc12-4352-b5a9-129f164f5bb6/documents/12190120-6b6e-49c5-bed7-264eab246437_94f85476-aed9-4c48-8ee1-14199f614a13.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Residues (petroleum), thermal cracked",64741-80-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b0cd87f-bc12-4352-b5a9-129f164f5bb6/documents/12190120-6b6e-49c5-bed7-264eab246437_94f85476-aed9-4c48-8ee1-14199f614a13.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), thermal cracked",64741-80-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b0cd87f-bc12-4352-b5a9-129f164f5bb6/documents/12190120-6b6e-49c5-bed7-264eab246437_94f85476-aed9-4c48-8ee1-14199f614a13.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, Propatylnitrate,2921-92-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bf367a3-2400-484e-8da8-f471b544b209/documents/b4138c9e-85c0-47ea-bb99-5847a2b7b134_add1a38f-c963-4f91-bcab-f1cb8a5a30b6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Carbon monoxide,630-08-0,"Repeat dose oral toxicity - waiverRepeat dose dermal toxicity - waiverRepeat dose inhalation toxicity: Bowden, A (2005) VAB004; Bowden, A (2005) VAB005; Sohaug, S (2006) (Rat - 72 week) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/033662d3-1203-4493-828b-21ac021bf303/documents/da238df0-035a-4568-82e4-9cf3a6c59b0a_9cf71476-96c3-41b6-818b-442aa6e24dcf.html,,,,,, Carbon monoxide,630-08-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/033662d3-1203-4493-828b-21ac021bf303/documents/da238df0-035a-4568-82e4-9cf3a6c59b0a_9cf71476-96c3-41b6-818b-442aa6e24dcf.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,116 mg/m3,,rat Carbon monoxide,630-08-0,"Acute oral toxicity - waiverAcute dermal toxicity - waiverAcute inhalation toxicity: Bowden, A (2005) VAB001; Author unknown (1970) HL 96-70; Rose et al., (1970). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/033662d3-1203-4493-828b-21ac021bf303/documents/9dd11856-f751-4b5c-ba2f-72e4ab8ff411_9cf71476-96c3-41b6-818b-442aa6e24dcf.html,,,,,, Carbon monoxide,630-08-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/033662d3-1203-4493-828b-21ac021bf303/documents/9dd11856-f751-4b5c-ba2f-72e4ab8ff411_9cf71476-96c3-41b6-818b-442aa6e24dcf.html,,inhalation,LC50,"1,489 mg/m3",, Pentaerithrityl tetranitrate,78-11-5," Reliable information on repeated dose toxicity shows a NOAEL of 2500 mg/kg bw/day.  Due to explosive properties of the substance, no further testing could be conducted. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9df7517-7eef-45d3-972d-edae229fcee6/documents/IUC5-9c5caacd-c4a2-48ae-bd14-a605bbd161d5_a082b894-d438-4be3-8790-7accc021af29.html,,,,,, Pentaerithrityl tetranitrate,78-11-5,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9df7517-7eef-45d3-972d-edae229fcee6/documents/IUC5-9c5caacd-c4a2-48ae-bd14-a605bbd161d5_a082b894-d438-4be3-8790-7accc021af29.html,Chronic toxicity – systemic effects,oral,NOAEL,"2,500 mg/kg bw/day",,rat Pentaerithrityl tetranitrate,78-11-5," According to results in rats and mice in the 14 days and 14 weeks- repeated dose toxicity assays, the value of acute LD50 (oral) can be considered as higher than the threshold for classification in any oral acute toxicity hazard categories. No additional reliable studies on acute toxicity are available. Due to explosive properties of the substance, no further testing could be conducted. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9df7517-7eef-45d3-972d-edae229fcee6/documents/IUC5-fb4d64af-8f48-4944-9efb-37bd85e16a39_a082b894-d438-4be3-8790-7accc021af29.html,,,,,, Antimony,7440-36-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/606e20f7-42c7-4b58-9da9-d33cfe5580ad/documents/60db74d8-0883-4f23-afeb-f9a8bbf670d9_82506d02-5818-4c04-be02-cd9935477d97.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,686 mg/kg bw/day",,rat Antimony,7440-36-0,LD50 (oral ): >20000 mg/kg bw/day LD50 (dermal): >8300 mg/kg bw LC50 (inhalation): >5200 mg/m³ ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/606e20f7-42c7-4b58-9da9-d33cfe5580ad/documents/ec3b85f1-478d-424b-b882-cf8b2fd3e3d2_82506d02-5818-4c04-be02-cd9935477d97.html,,,,,, "1,2-dimethoxyethane",110-71-4,"Several studies and read-across approaches have been performed, either with the test substance itself or its toxic metabolite 2-Methoxyethanol.Inhalation:NOAEC (14 days, 6h/d, whole body, male rat): 0.187 mg/L NOAEC (14 days, 6h/d, whole body, male/female rabbit): 0.187 mg/LNOAEC (14 days, whole body, male rat): < 0.374 mg/LNOAEC (14 days, whole body, pregnant rabbit): 0.374 mg/LNOEC (10 days, whole body, rat): 1000 ppmOral (read across to 2-Methoxyethanol, ametabolite of Ethylene glycol dimethyl ether):NOAEL (14 days, drinking water study, male mouse): 200 mg/kg bw/dNOAEL (14 days, drinking water study, female mouse): 600 mg/kg bw/dNOAEL (13 weeks, drinking water study, male/female mouse): < 2000 ppmLOAEL (14 days, drinking water study, male rat): 200 mg/kg bw/dLOAEL (14 days, drinking water study, female rat): 200 mg/kg bw/dNOAEL (13 weeks, drinking water study, male rat): < 750 ppm Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): No repeated dose toxicity study with oral application have been performed with ethylene glycol dimethyl ether, but sufficient information after inhalation is available. Additionally, data of the main toxic metabolite, 2-methoxyethanol, is available after oral dose administration. Here, a NOAEL of 200 mg/kg bw was observed. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66ad2581-0563-4c5d-b5d0-49663032335f/documents/IUC5-196eb350-8623-48b6-a4ff-39b8484be917_fe4a4cd0-7d3c-430a-a6fe-10669219061b.html,,,,,, "1,2-dimethoxyethane",110-71-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66ad2581-0563-4c5d-b5d0-49663032335f/documents/IUC5-196eb350-8623-48b6-a4ff-39b8484be917_fe4a4cd0-7d3c-430a-a6fe-10669219061b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "1,2-dimethoxyethane",110-71-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66ad2581-0563-4c5d-b5d0-49663032335f/documents/IUC5-196eb350-8623-48b6-a4ff-39b8484be917_fe4a4cd0-7d3c-430a-a6fe-10669219061b.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,187 mg/m3,,rat "1,2-dimethoxyethane",110-71-4,"Several acute toxicity studies were performed applying all exposure routes: oral, inhalation , and dermal.Oral:- female rats, LD50: 5370 mg/kg bw- female rats, LD50: > 4000 mg/kg bw- female mice, LD50: 2526 mg/kg bwInhalation:- male/female rats, LC0 (1h exposure): 240 mg/L -> 60 mg/L (4h calculated exposure)- rats, LC50 (6h exposure): > 20 mg/L- female rats, LC0 (1h exposure): 247 mg/L -> 61.8 mg/L (4h calculated exposure)Dermal:- female rats, LD50: > 5000 mg/kg bw- rabbits, LD50 ca. 2000 mg/kg bw ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66ad2581-0563-4c5d-b5d0-49663032335f/documents/IUC5-df2d0078-7b87-4b9e-ad77-e4904444d882_fe4a4cd0-7d3c-430a-a6fe-10669219061b.html,,,,,, "1,2-dimethoxyethane",110-71-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66ad2581-0563-4c5d-b5d0-49663032335f/documents/IUC5-df2d0078-7b87-4b9e-ad77-e4904444d882_fe4a4cd0-7d3c-430a-a6fe-10669219061b.html,,oral,LD50,"5,370 mg/kg bw",adverse effect observed, "1,2-dimethoxyethane",110-71-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66ad2581-0563-4c5d-b5d0-49663032335f/documents/IUC5-df2d0078-7b87-4b9e-ad77-e4904444d882_fe4a4cd0-7d3c-430a-a6fe-10669219061b.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "1,2-dimethoxyethane",110-71-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66ad2581-0563-4c5d-b5d0-49663032335f/documents/IUC5-df2d0078-7b87-4b9e-ad77-e4904444d882_fe4a4cd0-7d3c-430a-a6fe-10669219061b.html,,inhalation,LC50,> 20 mg/L,adverse effect observed, "pymetrozine (ISO); (E)-4,5-dihydro-6-methyl-4-(3-pyridylmethyleneamino)-1,2,4-triazin-3(2H)-one",123312-89-0," - Oral: NOAEL = 100 ppm (both sexes), equivalent to dose levels of 3.12 mg/kg bw/day for males and 3.24 mg/kg bw/day for females, dogs, sub-chronic, 3 months, feeding, OECD 409, Altmann 1992 ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef4b984e-2f20-48cc-81ce-f5dd49b0f063/documents/25422588-9418-4808-a39c-b69ffa53e453_859d3ed8-91a4-40f9-b0e8-eb2a8fe14b54.html,,,,,, "pymetrozine (ISO); (E)-4,5-dihydro-6-methyl-4-(3-pyridylmethyleneamino)-1,2,4-triazin-3(2H)-one",123312-89-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef4b984e-2f20-48cc-81ce-f5dd49b0f063/documents/25422588-9418-4808-a39c-b69ffa53e453_859d3ed8-91a4-40f9-b0e8-eb2a8fe14b54.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,3.12 mg/kg bw/day,,dog "pymetrozine (ISO); (E)-4,5-dihydro-6-methyl-4-(3-pyridylmethyleneamino)-1,2,4-triazin-3(2H)-one",123312-89-0," - Oral: LD50 = 5693 mg/kg bw, male rats (Hsd:Sprague Dawley SD), US EPA 81-1, Glaza 1991 - Dermal: LD50 >2000 mg/kg bw, male/female, rats (Hsd:Sprague Dawley SD), US EPA 81-2, Glaza 1991 ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef4b984e-2f20-48cc-81ce-f5dd49b0f063/documents/f49e87ce-cb12-4069-a419-48ae86b40162_859d3ed8-91a4-40f9-b0e8-eb2a8fe14b54.html,,,,,, "pymetrozine (ISO); (E)-4,5-dihydro-6-methyl-4-(3-pyridylmethyleneamino)-1,2,4-triazin-3(2H)-one",123312-89-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef4b984e-2f20-48cc-81ce-f5dd49b0f063/documents/f49e87ce-cb12-4069-a419-48ae86b40162_859d3ed8-91a4-40f9-b0e8-eb2a8fe14b54.html,,oral,LD50,"5,693 mg/kg bw",adverse effect observed, "pymetrozine (ISO); (E)-4,5-dihydro-6-methyl-4-(3-pyridylmethyleneamino)-1,2,4-triazin-3(2H)-one",123312-89-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef4b984e-2f20-48cc-81ce-f5dd49b0f063/documents/f49e87ce-cb12-4069-a419-48ae86b40162_859d3ed8-91a4-40f9-b0e8-eb2a8fe14b54.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Chloroethane,75-00-3," 90 days inhalation NOAEC (rats) = 50310 mg/m³ (NTP, 1989) 90 days inhalation NOAEC (mice) = 50310 mg/m³ (NTP, 1989) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8f04557-c359-42ed-a69c-c4a6e7f1e89b/documents/4df44556-87a1-4f7b-bfb8-e145f710a258_bddf7787-9d14-47d0-ab3e-77741342d314.html,,,,,, Chloroethane,75-00-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8f04557-c359-42ed-a69c-c4a6e7f1e89b/documents/4df44556-87a1-4f7b-bfb8-e145f710a258_bddf7787-9d14-47d0-ab3e-77741342d314.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"50,310 mg/m3",,other:rat and mouse Chloroethane,75-00-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8f04557-c359-42ed-a69c-c4a6e7f1e89b/documents/4df44556-87a1-4f7b-bfb8-e145f710a258_bddf7787-9d14-47d0-ab3e-77741342d314.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"50,310 mg/m3",no adverse effect observed,other:rat and mouse Chloroethane,75-00-3,"inhalation: LC50 (rat/mouse) > 19000 ppm (NTP, 1989) ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8f04557-c359-42ed-a69c-c4a6e7f1e89b/documents/e7bd5dec-629d-44d5-91b7-125cff38533e_bddf7787-9d14-47d0-ab3e-77741342d314.html,,,,,, Chloroethane,75-00-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8f04557-c359-42ed-a69c-c4a6e7f1e89b/documents/e7bd5dec-629d-44d5-91b7-125cff38533e_bddf7787-9d14-47d0-ab3e-77741342d314.html,,inhalation,LC50,"50,130 mg/m3",no adverse effect observed, "Residual oils (petroleum), hydrotreated solvent dewaxed",90669-74-2,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEL (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils. A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study that tested distillate aromatic extracts. Sufficiently refined other lubricant baseoils are not classified according to DSD for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/386a7455-d53d-41fc-9df3-1724d58fa798/documents/IUC5-748bb69d-ce48-462f-89ca-bdf2ce955fad_7514bcac-4221-41d6-aa2c-2aefc392bf64.html,,,,,, "Residual oils (petroleum), hydrotreated solvent dewaxed",90669-74-2,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. The acute inhalation LC50 for other lubricant base oils is >5.0 mg/L. ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/386a7455-d53d-41fc-9df3-1724d58fa798/documents/IUC5-69a65843-7186-4761-8d35-387911c0bc26_7514bcac-4221-41d6-aa2c-2aefc392bf64.html,,,,,, "α-n-butyl-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile",88671-89-0,"Two dietary studies with exposure of male and female rats for 13 weeks are available. Both studies are well-documented and include parameters comparable to guideline 408. NOAEL = 18.8 mg/kg bw/day A dietary study with exposure of male and female dogs for 1 year is available. The study is well-documented and include parameters comparable to guideline 452 and 409. NOAEL = 3.09 mg/kg bw/day Liver was found to be the main target organ in both species.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises adequate, reliable and consistent studies, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.6, of Regulation (EC) No 1907/2006 ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb8edaaf-3ba6-428b-8a50-84cd3d5580ed/documents/6b858e8a-eb47-4ad4-814a-c0088c782a3b_2daf76fb-51a9-4c1a-9ff4-3ca7484f6062.html,,,,,, "α-n-butyl-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile",88671-89-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb8edaaf-3ba6-428b-8a50-84cd3d5580ed/documents/6b858e8a-eb47-4ad4-814a-c0088c782a3b_2daf76fb-51a9-4c1a-9ff4-3ca7484f6062.html,Chronic toxicity – systemic effects,oral,NOAEL,3.09 mg/kg bw/day,,dog "α-n-butyl-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile",88671-89-0,"Acute toxicity studies performed via oral, dermal and inhalation route are available. The studies were performed according to OECD/EC guidelines and GLP principles. This data indicate that myclobutanil is of low acute toxicity via the dermal and inhalation route. The substance was shown to have adverse effects when administered via the oral route.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available study is reliable (Klimisch 1). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): A reliable study is available (Klimisch 1). Testing was done at the maximum attainable concentration. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): A reliable study is available (Klimisch 1). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb8edaaf-3ba6-428b-8a50-84cd3d5580ed/documents/d9b314f4-cef2-4d96-a749-f7c3d59176da_2daf76fb-51a9-4c1a-9ff4-3ca7484f6062.html,,,,,, "α-n-butyl-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile",88671-89-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb8edaaf-3ba6-428b-8a50-84cd3d5580ed/documents/d9b314f4-cef2-4d96-a749-f7c3d59176da_2daf76fb-51a9-4c1a-9ff4-3ca7484f6062.html,,oral,LD50,"> 1,750 mg/kg bw",adverse effect observed, "α-n-butyl-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile",88671-89-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb8edaaf-3ba6-428b-8a50-84cd3d5580ed/documents/d9b314f4-cef2-4d96-a749-f7c3d59176da_2daf76fb-51a9-4c1a-9ff4-3ca7484f6062.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "α-n-butyl-α-(4-chlorophenyl)-1H-1,2,4-triazole-1-propanenitrile",88671-89-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb8edaaf-3ba6-428b-8a50-84cd3d5580ed/documents/d9b314f4-cef2-4d96-a749-f7c3d59176da_2daf76fb-51a9-4c1a-9ff4-3ca7484f6062.html,,inhalation,LC50,> 5.88 mg/L,no adverse effect observed, Succinonitrile,110-61-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efb5dc67-c817-44f2-815d-a89c88cc0654/documents/8efa56c3-9515-4c19-b745-8cab8aaef9fa_5fc2dccb-7cce-4c56-885a-e33925d38231.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,70 mg/kg bw/day,,rat Succinonitrile,110-61-2, An inhalation toxicity study and an acute dermal toxicity study were performed in accordance with the current OECD guideline. Both studies are reliable with restrictions. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efb5dc67-c817-44f2-815d-a89c88cc0654/documents/IUC5-aadfdc1b-889e-4586-87e1-38b0ddbc2e0e_5fc2dccb-7cce-4c56-885a-e33925d38231.html,,,,,, Succinonitrile,110-61-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efb5dc67-c817-44f2-815d-a89c88cc0654/documents/IUC5-aadfdc1b-889e-4586-87e1-38b0ddbc2e0e_5fc2dccb-7cce-4c56-885a-e33925d38231.html,,oral,LD50,300 mg/kg bw,, Succinonitrile,110-61-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efb5dc67-c817-44f2-815d-a89c88cc0654/documents/IUC5-aadfdc1b-889e-4586-87e1-38b0ddbc2e0e_5fc2dccb-7cce-4c56-885a-e33925d38231.html,,inhalation,discriminating conc.,"2,670 mg/m3",, "Residues (petroleum), vacuum, light",90669-76-4," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7495627a-e9d3-4023-8953-ea62192192e7/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_f58079be-bfbe-4643-8baf-2d2841d69c0b.html,,,,,, "Residues (petroleum), vacuum, light",90669-76-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7495627a-e9d3-4023-8953-ea62192192e7/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_f58079be-bfbe-4643-8baf-2d2841d69c0b.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Residues (petroleum), vacuum, light",90669-76-4,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7495627a-e9d3-4023-8953-ea62192192e7/documents/12190120-6b6e-49c5-bed7-264eab246437_f58079be-bfbe-4643-8baf-2d2841d69c0b.html,,,,,, "Residues (petroleum), vacuum, light",90669-76-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7495627a-e9d3-4023-8953-ea62192192e7/documents/12190120-6b6e-49c5-bed7-264eab246437_f58079be-bfbe-4643-8baf-2d2841d69c0b.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Residues (petroleum), vacuum, light",90669-76-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7495627a-e9d3-4023-8953-ea62192192e7/documents/12190120-6b6e-49c5-bed7-264eab246437_f58079be-bfbe-4643-8baf-2d2841d69c0b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), vacuum, light",90669-76-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7495627a-e9d3-4023-8953-ea62192192e7/documents/12190120-6b6e-49c5-bed7-264eab246437_f58079be-bfbe-4643-8baf-2d2841d69c0b.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "Gases (petroleum), depropanizer dry, propene-rich",68477-90-7," Only one stream (Liquified Petroleum Gases CAS 68476 -85 -7) of the Other Petroleum Gases category has been tested but this and the main constituents of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and humans. The mammalian toxicity effects of this category will be driven by the content of benzene if the latter is present at levels of >10%. Additionally, the category may contain carbon monoxide which could trigger classification. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ca7135a-0bf7-4498-821e-f350b1d4cc90/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_dcf0fffe-21eb-4979-a839-1dcf7c3858a6.html,,,,,, "Gases (petroleum), depropanizer dry, propene-rich",68477-90-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ca7135a-0bf7-4498-821e-f350b1d4cc90/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_dcf0fffe-21eb-4979-a839-1dcf7c3858a6.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"7,214 mg/m3",,rat "Gases (petroleum), depropanizer dry, propene-rich",68477-90-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ca7135a-0bf7-4498-821e-f350b1d4cc90/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_dcf0fffe-21eb-4979-a839-1dcf7c3858a6.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"8,600 mg/m3",adverse effect observed,rat "Gases (petroleum), depropanizer dry, propene-rich",68477-90-7," Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the constituents. Across species, main constituent gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene in streams where it is present at levels of <1%. However, some streams in this category may contain benzene levels >1% or carbon monoxide which could trigger classification. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ca7135a-0bf7-4498-821e-f350b1d4cc90/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_dcf0fffe-21eb-4979-a839-1dcf7c3858a6.html,,,,,, "Gases (petroleum), depropanizer dry, propene-rich",68477-90-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ca7135a-0bf7-4498-821e-f350b1d4cc90/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_dcf0fffe-21eb-4979-a839-1dcf7c3858a6.html,,inhalation,LC50,"22,948 mg/m3",no adverse effect observed, "Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted",68814-89-1,"After subacute dermal exposure to DAEs (equivalent to OECD 410), no signs of systemic toxicity were observed even at the high dose, 1000 mg/kg/day. After subchronic dermal exposure to DAEs (equivalent to OECD 411), a NOAEL could not be established since toxicity was observed at all dosing levels, including the lowest dose tested. The authors considered the NOAEL for dermal exposure to be less than 30 mg/kg/day. The NOAEL for oral exposure after subchronic exposure to an DAE was less than 125 mg/kg (OECD 408). After subacute inhalation exposure to Other Lubricant Base Oils (equivalent to OECD 412), the overall NOAEL for systemic effects was determined to be > 980 mg/m3. Animals were exposed to OLBOs in subacute (OECD 410), subchronic (OECD 411), and chronic (OECD 453) dermal toxicity tests, and the resulting NOAELs based on systemic toxicity were > 1000 mg/kg bw/day, > 2000 mg/kg bw/day, and > 75 μL/week, respectively. ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/25902d34-a4de-4611-9f21-344bb2e5f5dc/documents/IUC5-5fa5ed62-6d35-465c-a77c-c41a1909268b_393ab02b-77b4-447a-9dc1-a171c3159cce.html,,,,,, "Extracts (petroleum), heavy paraffinic distillates, solvent-deasphalted",68814-89-1,"Key read-across acute oral, dermal, and inhalation toxicity studies were identified from distillate aromatic extracts and other lubricant base oils (OLBO; IP 346 < 3%) Results for key studies are as follows:• The oral LD50 was > 5000 mg/kg bw in male and female rats for DAEs in an acute oral study (similar to OECD 401).• The oral LD50 was > 5000 mg/kg bw in male and female rats for OLBO (IP 346 < 3%) in an acute oral study (OECD 401).• The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for DAEs in an acute dermal study (similar to OECD 402).• The dermal LD50 was > 5000 mg/kg/bw in male and female rabbits for OLBO (IP 346 < 3%) in an acute dermal study (OECD 402).• The inhalation LC50 was > 5 mg/L in male and female rats for DAEs in an acute inhalation study (OECD 403).• The inhalation LC50 was > 5.53 mg/L in male and female rats for OLBO (IP 346 < 3%) in an acute inhalation study (OECD 403). ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25902d34-a4de-4611-9f21-344bb2e5f5dc/documents/IUC5-01290a09-7ed3-464b-b310-1febb2141f19_393ab02b-77b4-447a-9dc1-a171c3159cce.html,,,,,, "Petroleum gases, liquefied, sweetened",68476-86-8,"Only one stream (Liquified Petroleum Gases CAS 68476 -85 -7) of the Other Petroleum Gases category has been tested but this and the main constituents of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and humans. The mammalian toxicity effects of this category will be driven by the content of benzene if the latter is present at levels of >10%. Additionally, the category may contain carbon monoxide which could trigger classification.   ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b416f8b5-f1ba-4c3c-bb8c-49a672843384/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_7a6b556b-7ee8-4d51-a465-e3f1bab8982f.html,,,,,, "Petroleum gases, liquefied, sweetened",68476-86-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b416f8b5-f1ba-4c3c-bb8c-49a672843384/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_7a6b556b-7ee8-4d51-a465-e3f1bab8982f.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"7,214 mg/m3",,rat "Petroleum gases, liquefied, sweetened",68476-86-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b416f8b5-f1ba-4c3c-bb8c-49a672843384/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_7a6b556b-7ee8-4d51-a465-e3f1bab8982f.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"8,600 mg/m3",adverse effect observed,rat "Petroleum gases, liquefied, sweetened",68476-86-8,"Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the constituents. Across species, main constituent gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene in streams where it is present at levels of <1%. However, some streams in this category may contain benzene levels >1% or carbon monoxide which could trigger classification. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b416f8b5-f1ba-4c3c-bb8c-49a672843384/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_7a6b556b-7ee8-4d51-a465-e3f1bab8982f.html,,,,,, "Petroleum gases, liquefied, sweetened",68476-86-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b416f8b5-f1ba-4c3c-bb8c-49a672843384/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_7a6b556b-7ee8-4d51-a465-e3f1bab8982f.html,,inhalation,LC50,"22,948 mg/m3",no adverse effect observed, "Slack wax (petroleum), clay-treated",90669-78-6,"No oral repeat dose toxicity data are available for slack waxes (non-carcinogenic feed-stock). Data are available on similar materials (Paraffin waxes) to adequately characterize the repeated dose toxicity of slack waxes (Non-carcinogenic feed-stock). The data are consistent in that they demonstrate that paraffin and hydrocarbon waxes were found to be of low acute toxicity by the oral route.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for slack waxes (carcinogenic or unknown feed-stock) using read-across to a 90-day subchronic toxicity study that tested untreated distillate aromatic extracts. For dermal repeat dose toxicity, data are available on similar materials to adequately characterize the repeated dose toxicity of  slack waxes (carcinogenic or unknown feed-stock and non-carcinogenic feed-stock). The data are consistent in that they demonstrate minimal effects in rabbits with the exception of minimal to moderate skin irritation following repeated dermal exposures. For inhalation repeat dose toxicity, no data are available on slack waxes.  However, inhalation exposure to slack waxes is not expected to occur under normal conditions due to the very low vapour pressures of these substances. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dfc9e100-603e-46ee-862b-c53d67fe7bc5/documents/bfab73c8-6f6d-4fd7-9346-ff1bf3d1b7c2_f2f4b70c-d1f3-4e2c-80cf-5ad5e0c06604.html,,,,,, "Slack wax (petroleum), clay-treated",90669-78-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dfc9e100-603e-46ee-862b-c53d67fe7bc5/documents/bfab73c8-6f6d-4fd7-9346-ff1bf3d1b7c2_f2f4b70c-d1f3-4e2c-80cf-5ad5e0c06604.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Slack wax (petroleum), clay-treated",90669-78-6,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dfc9e100-603e-46ee-862b-c53d67fe7bc5/documents/bfab73c8-6f6d-4fd7-9346-ff1bf3d1b7c2_f2f4b70c-d1f3-4e2c-80cf-5ad5e0c06604.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Slack wax (petroleum), clay-treated",90669-78-6,Read-across toxicity studies for acute oral (OECD 401) and dermal (OECD 402) toxicity  were identified for slack waxes (carcinogenic or unknown feed-stock and non-carcinogenic feedstock).  No acute inhalation toxicity studieshave been reported for slack waxes since inhalation exposure is not expected to occur under normal conditions due to the very low vapour pressures of these substances. LD50 values were as follows:• The oral LD50 was > 5000 mg/kg bw in male and female rats.• The dermal LD50 was > 2000 or 5000 mg/kg bw in male and female rabbits. ,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfc9e100-603e-46ee-862b-c53d67fe7bc5/documents/d768da8b-e789-4187-9286-e7a5f3f89a50_f2f4b70c-d1f3-4e2c-80cf-5ad5e0c06604.html,,,,,, "Slack wax (petroleum), clay-treated",90669-78-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfc9e100-603e-46ee-862b-c53d67fe7bc5/documents/d768da8b-e789-4187-9286-e7a5f3f89a50_f2f4b70c-d1f3-4e2c-80cf-5ad5e0c06604.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Slack wax (petroleum), clay-treated",90669-78-6,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfc9e100-603e-46ee-862b-c53d67fe7bc5/documents/d768da8b-e789-4187-9286-e7a5f3f89a50_f2f4b70c-d1f3-4e2c-80cf-5ad5e0c06604.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gases (petroleum), C3-4, isobutane-rich",68477-33-8," Members of the C4 high 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. Data after inhalational exposure are available on one of the streams in this category (All CAS numbers are; 68476-52-8, 68477-42-9, 68955-28-2, 87741-01-3, 92045-23-3) and on the constituent substances (1,3-butadiene, butane, isobutane and butene isomers) and indicate that the sub-chronic toxicity of this category is low. Inhalation exposure is the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in rats or mice in inhalation studies ranging from 7 weeks to 2 years on CAS no. 68476-52-82, butane, isobutane and 2-methylpropene. Nasal lesions were observed in 2 year studies on 2-methylpropene at the highest concentration in male rats. 1,3-Butadiene had low repeat dose toxicity in humans and rats (the most appropriate test species). The mouse was the most sensitive species where the target organs are bone marrow, ovary and testis. Species differences in metabolism are believed to be responsible for the species specific toxicity with humans being more similar to rats The NOAEL of 1000 ppm (2212 mg/m3) was identified from the key study on 1,3-butadiene in rats. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e244d3ed-e17f-4eeb-8187-fb8e5ee68a5b/documents/IUC5-106b9c59-8ac8-4eb0-8b6a-307fee43b208_a1a98aab-d18f-4483-b69d-5166958848cf.html,,,,,, "Gases (petroleum), C3-4, isobutane-rich",68477-33-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e244d3ed-e17f-4eeb-8187-fb8e5ee68a5b/documents/IUC5-106b9c59-8ac8-4eb0-8b6a-307fee43b208_a1a98aab-d18f-4483-b69d-5166958848cf.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"2,212 mg/m3",, "Gases (petroleum), C3-4, isobutane-rich",68477-33-8,"Members of the C4 high 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. Data are available on some members of the streams in this category (All CAS numbers are; 68476-52-8, 68477-42-9, 68955-28-2, 87741-01-3, 92045-23-3) and on the constituent substances (1,3-butadiene, butane, isobutane and butene isomers) and indicate that the acute inhalational toxicity of this category is low. The LC50 values are in excess of 10,000 ppm (22,948 mg/m3), limited data suggests that 1,3-butadiene is not acutely toxic in humans and butane and isobutane are considered to be Generally Recognised as Safe and may be used in food products. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e244d3ed-e17f-4eeb-8187-fb8e5ee68a5b/documents/IUC5-de665b61-fce1-4b81-8865-57fe756193bf_a1a98aab-d18f-4483-b69d-5166958848cf.html,,,,,, "Gas oils (petroleum), hydrotreated vacuum",64742-59-2," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f633ac55-49f5-434a-8498-8d84a51c56b6/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_401ae25e-a879-4dbd-a8cd-0a0042367862.html,,,,,, "Gas oils (petroleum), hydrotreated vacuum",64742-59-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f633ac55-49f5-434a-8498-8d84a51c56b6/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_401ae25e-a879-4dbd-a8cd-0a0042367862.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Gas oils (petroleum), hydrotreated vacuum",64742-59-2,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f633ac55-49f5-434a-8498-8d84a51c56b6/documents/12190120-6b6e-49c5-bed7-264eab246437_401ae25e-a879-4dbd-a8cd-0a0042367862.html,,,,,, "Gas oils (petroleum), hydrotreated vacuum",64742-59-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f633ac55-49f5-434a-8498-8d84a51c56b6/documents/12190120-6b6e-49c5-bed7-264eab246437_401ae25e-a879-4dbd-a8cd-0a0042367862.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), hydrotreated vacuum",64742-59-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f633ac55-49f5-434a-8498-8d84a51c56b6/documents/12190120-6b6e-49c5-bed7-264eab246437_401ae25e-a879-4dbd-a8cd-0a0042367862.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), hydrotreated vacuum",64742-59-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f633ac55-49f5-434a-8498-8d84a51c56b6/documents/12190120-6b6e-49c5-bed7-264eab246437_401ae25e-a879-4dbd-a8cd-0a0042367862.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "Fuel gases, crude oil distillates",68476-29-9,"Only one stream of the Other Petroleum Gases category has been tested but this and the main components of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. The mammalian toxicity effects of this category will be not driven by the content of benzene as the latter is present at levels of <0.3%, however, the category may contain carbon monoxide which could trigger classification. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58fa266a-847b-4c86-9b40-37e9acb34595/documents/IUC5-5a55592f-8b72-4e82-bb98-63a06aaf7d45_62fb9c40-7b60-4a93-8918-63c02bc129e7.html,,,,,, "Fuel gases, crude oil distillates",68476-29-9,"Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the component substances. Across species, main component gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 ¿ 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene as the latter is present at levels of <0.3%, however, the category may contain carbon monoxide and/or hydrogen sulphide which could trigger classification. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58fa266a-847b-4c86-9b40-37e9acb34595/documents/IUC5-02176948-0c88-42d0-83b5-5edbdb9e65a5_62fb9c40-7b60-4a93-8918-63c02bc129e7.html,,,,,, Furan,110-00-9,"In rat and mouse studies up to 13-weeks duration, the liver was identified as the main target organ in both species. Also in rats, the kidneys, thymus, testes and ovaries were also affected. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88b4388d-875f-4940-b662-36a6dc293c02/documents/IUC5-03a1b900-6389-45f2-bce1-dae073c581c9_fb4061a6-8957-4af2-bdd9-580a8f83eb3c.html,,,,,, Furan,110-00-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88b4388d-875f-4940-b662-36a6dc293c02/documents/IUC5-03a1b900-6389-45f2-bce1-dae073c581c9_fb4061a6-8957-4af2-bdd9-580a8f83eb3c.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,4 mg/kg bw/day,,rat Furan,110-00-9,"There are several reviews and data summaries but limited primary data on the acute toxicity of furan. No primary data on acute oral or acute dermal toxicity were identified. Two published primary sources, that have been entered into IUCLID, report one-hour inhalation exposures to measured concentrations of furan vapour in mice and rats (Egle & Gochberg, 1979; Terrill et al., 1989). Neither is reported in sufficient detail to merit a reliability score or 1 or 2, or to qualify as a key study. The study in mice (Egle & Gochberg, 1979) is compromised by small experimental groups. The one-hour LC50 values reported for these studies are 0.12 mg/l in the mouse (Egle & Gochberg, 1979) and 3464 ppm (approx. 9.6 mg/l) in male and female rats, with a lower value of 3398 ppm (approx. 9.5 mg/l) for male rats (Terrill et al., 1989). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88b4388d-875f-4940-b662-36a6dc293c02/documents/IUC5-23fb580a-9aa4-4355-91a1-79be14592a95_fb4061a6-8957-4af2-bdd9-580a8f83eb3c.html,,,,,, Chinomethionate,2439-01-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 1 ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff50d1bf-b270-488e-8240-d2b8cf5e9528/documents/a559553e-aed0-4ad6-88c1-aa7647cca7d7_c86c32c9-80a9-4108-a531-23c3425e63bc.html,,,,,, Chinomethionate,2439-01-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff50d1bf-b270-488e-8240-d2b8cf5e9528/documents/a559553e-aed0-4ad6-88c1-aa7647cca7d7_c86c32c9-80a9-4108-a531-23c3425e63bc.html,,oral,LD50,"1,095 mg/kg bw",adverse effect observed, "Distillates (petroleum), clay-treated heavy naphthenic",64742-44-5,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e32fd78a-0755-413d-aae7-35afb1f51fac/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_bb0577bf-30f6-4394-aa76-7fa497d4bf28.html,,,,,, "Distillates (petroleum), clay-treated heavy naphthenic",64742-44-5,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e32fd78a-0755-413d-aae7-35afb1f51fac/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_bb0577bf-30f6-4394-aa76-7fa497d4bf28.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Distillates (petroleum), clay-treated heavy naphthenic",64742-44-5,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e32fd78a-0755-413d-aae7-35afb1f51fac/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_bb0577bf-30f6-4394-aa76-7fa497d4bf28.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Distillates (petroleum), clay-treated heavy naphthenic",64742-44-5,,2025-01-24,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e32fd78a-0755-413d-aae7-35afb1f51fac/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_bb0577bf-30f6-4394-aa76-7fa497d4bf28.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Distillates (petroleum), clay-treated heavy naphthenic",64742-44-5,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e32fd78a-0755-413d-aae7-35afb1f51fac/documents/73761dae-46d6-428e-8e40-e5cc70088d96_bb0577bf-30f6-4394-aa76-7fa497d4bf28.html,,,,,, "Distillates (petroleum), clay-treated heavy naphthenic",64742-44-5,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e32fd78a-0755-413d-aae7-35afb1f51fac/documents/73761dae-46d6-428e-8e40-e5cc70088d96_bb0577bf-30f6-4394-aa76-7fa497d4bf28.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), clay-treated heavy naphthenic",64742-44-5,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e32fd78a-0755-413d-aae7-35afb1f51fac/documents/73761dae-46d6-428e-8e40-e5cc70088d96_bb0577bf-30f6-4394-aa76-7fa497d4bf28.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), clay-treated heavy naphthenic",64742-44-5,,2025-01-24,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e32fd78a-0755-413d-aae7-35afb1f51fac/documents/73761dae-46d6-428e-8e40-e5cc70088d96_bb0577bf-30f6-4394-aa76-7fa497d4bf28.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Distillates (petroleum), intermediate catalytic cracked",64741-60-2,"No repeat dose toxicity studies have been identified for cracked gas oils, following inhalation or oral exposure. The sub-chronic inhalation study of diesel fuel (OECD 413, a read-across study from VGO/HGO/Distillate Fuels) resulted in a conservative sub-chronic NOAEC of 0.88 mg/L determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of ≥1.71 mg/L was established for systemic effects, based on no significant findings at this level.In a 28-day sub-acute study (OECD 410), dermal exposure to a light catalytically cracked distillate resulted in limited systemic changes and a NOAEL of 500 mg/kg body weight/day.  In a 90-day sub-chronic study (OECD 411), dermal exposure to light catalytically cracked distillate resulted in a systemic NOAEL of 25 mg/kg body weight/day for males, and 125 mg/kg body weight/day for females, based upon reductions in thymus weight.  In another 90-day sub-chronic study (OECD 411), dermal exposure to coker light gas oil resulted in a systemic LOAEL of 30 mg/kg body weight/day for males and females, based upon clinical signs and irritation noted at all doses. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60b199a3-d761-4238-9143-df8371526cba/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_3f47ee9f-53d4-4754-967f-cb58ca98f707.html,,,,,, "Distillates (petroleum), intermediate catalytic cracked",64741-60-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60b199a3-d761-4238-9143-df8371526cba/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_3f47ee9f-53d4-4754-967f-cb58ca98f707.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), intermediate catalytic cracked",64741-60-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60b199a3-d761-4238-9143-df8371526cba/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_3f47ee9f-53d4-4754-967f-cb58ca98f707.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Distillates (petroleum), intermediate catalytic cracked",64741-60-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60b199a3-d761-4238-9143-df8371526cba/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_3f47ee9f-53d4-4754-967f-cb58ca98f707.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Distillates (petroleum), intermediate catalytic cracked",64741-60-2,"Acute Oral Toxicity:Acute oral toxicity of cracked gas oils was evaluated in male and female rats by a single oral gavage administration of a dose ranging from 2050 to 6250 mg/kg body weight.  Based on mortality and toxicity findings, an oral LD50 of 4660 mg/kg body weight and 3200 mg/kg body weight were reported for males and females, respectively.  Acute Inhalation Toxicity:Acute inhalation toxicity of cracked gas oils in rats was evaluated via whole-body exposure to test material at various measured concentrations for 4 hours.  The acute inhalation LC50 was 4.65 mg/L in males and females. Acute Dermal Toxicity:Acute dermal toxicity of cracked gas oils was evaluated in male and female rabbits at a single dose of 2000 mg/kg body weight.  Based on a lack of adverse systemic effects or mortality, the acute dermal LD50 for light catalytically cracked distillate was >2000 mg/kg body weight.   ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60b199a3-d761-4238-9143-df8371526cba/documents/61f4e539-9411-462c-acca-769cdd71de1b_3f47ee9f-53d4-4754-967f-cb58ca98f707.html,,,,,, "Distillates (petroleum), intermediate catalytic cracked",64741-60-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60b199a3-d761-4238-9143-df8371526cba/documents/61f4e539-9411-462c-acca-769cdd71de1b_3f47ee9f-53d4-4754-967f-cb58ca98f707.html,,oral,LD50,"3,200 mg/kg bw",no adverse effect observed, "Distillates (petroleum), intermediate catalytic cracked",64741-60-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60b199a3-d761-4238-9143-df8371526cba/documents/61f4e539-9411-462c-acca-769cdd71de1b_3f47ee9f-53d4-4754-967f-cb58ca98f707.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), intermediate catalytic cracked",64741-60-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60b199a3-d761-4238-9143-df8371526cba/documents/61f4e539-9411-462c-acca-769cdd71de1b_3f47ee9f-53d4-4754-967f-cb58ca98f707.html,,inhalation,LC50,"4,650 mg/m3",adverse effect observed, "Residues (petroleum), steam-cracked light",68513-69-9,"Repeated dose toxicity data are not available for Fuel Oils streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene - when present at 10%). The available data on the marker constituent DCPD do not reveal any specific target organ toxicity of a severity that would warrant classification. Therefore, no classification or labelling is warranted for streams which only contain these components. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4929e05-dcc1-4bc1-a528-b0783c1f368a/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_fc1245e4-e68d-4bac-b3d3-061093f3fe9f.html,,,,,, "Residues (petroleum), steam-cracked light",68513-69-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4929e05-dcc1-4bc1-a528-b0783c1f368a/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_fc1245e4-e68d-4bac-b3d3-061093f3fe9f.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Residues (petroleum), steam-cracked light",68513-69-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4929e05-dcc1-4bc1-a528-b0783c1f368a/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_fc1245e4-e68d-4bac-b3d3-061093f3fe9f.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Residues (petroleum), steam-cracked light",68513-69-9,"Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen.The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene.   Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene.   Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene. Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4929e05-dcc1-4bc1-a528-b0783c1f368a/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_fc1245e4-e68d-4bac-b3d3-061093f3fe9f.html,,,,,, "Residues (petroleum), steam-cracked light",68513-69-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4929e05-dcc1-4bc1-a528-b0783c1f368a/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_fc1245e4-e68d-4bac-b3d3-061093f3fe9f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), steam-cracked light",68513-69-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4929e05-dcc1-4bc1-a528-b0783c1f368a/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_fc1245e4-e68d-4bac-b3d3-061093f3fe9f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), steam-cracked light",68513-69-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4929e05-dcc1-4bc1-a528-b0783c1f368a/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_fc1245e4-e68d-4bac-b3d3-061093f3fe9f.html,,inhalation,LC50,"1,600 mg/m3",no adverse effect observed, "Residues (petroleum), topping plant, low-sulfur",68607-30-7," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a58286b-07a7-4504-9fe9-b5bf11918990/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_a194385c-310d-4bb3-b6f0-5011a7222c5d.html,,,,,, "Residues (petroleum), topping plant, low-sulfur",68607-30-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a58286b-07a7-4504-9fe9-b5bf11918990/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_a194385c-310d-4bb3-b6f0-5011a7222c5d.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Residues (petroleum), topping plant, low-sulfur",68607-30-7,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a58286b-07a7-4504-9fe9-b5bf11918990/documents/12190120-6b6e-49c5-bed7-264eab246437_a194385c-310d-4bb3-b6f0-5011a7222c5d.html,,,,,, "Residues (petroleum), topping plant, low-sulfur",68607-30-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a58286b-07a7-4504-9fe9-b5bf11918990/documents/12190120-6b6e-49c5-bed7-264eab246437_a194385c-310d-4bb3-b6f0-5011a7222c5d.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Residues (petroleum), topping plant, low-sulfur",68607-30-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a58286b-07a7-4504-9fe9-b5bf11918990/documents/12190120-6b6e-49c5-bed7-264eab246437_a194385c-310d-4bb3-b6f0-5011a7222c5d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), topping plant, low-sulfur",68607-30-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a58286b-07a7-4504-9fe9-b5bf11918990/documents/12190120-6b6e-49c5-bed7-264eab246437_a194385c-310d-4bb3-b6f0-5011a7222c5d.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "Distillates (petroleum), petroleum residues vacuum",68955-27-1," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9aa9d9ca-7823-4af4-ab51-a3e5ebac169b/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_e16d6733-ca3a-429b-9b08-c8e6a36b9038.html,,,,,, "Distillates (petroleum), petroleum residues vacuum",68955-27-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9aa9d9ca-7823-4af4-ab51-a3e5ebac169b/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_e16d6733-ca3a-429b-9b08-c8e6a36b9038.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Distillates (petroleum), petroleum residues vacuum",68955-27-1,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9aa9d9ca-7823-4af4-ab51-a3e5ebac169b/documents/12190120-6b6e-49c5-bed7-264eab246437_e16d6733-ca3a-429b-9b08-c8e6a36b9038.html,,,,,, "Distillates (petroleum), petroleum residues vacuum",68955-27-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9aa9d9ca-7823-4af4-ab51-a3e5ebac169b/documents/12190120-6b6e-49c5-bed7-264eab246437_e16d6733-ca3a-429b-9b08-c8e6a36b9038.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Distillates (petroleum), petroleum residues vacuum",68955-27-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9aa9d9ca-7823-4af4-ab51-a3e5ebac169b/documents/12190120-6b6e-49c5-bed7-264eab246437_e16d6733-ca3a-429b-9b08-c8e6a36b9038.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), petroleum residues vacuum",68955-27-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9aa9d9ca-7823-4af4-ab51-a3e5ebac169b/documents/12190120-6b6e-49c5-bed7-264eab246437_e16d6733-ca3a-429b-9b08-c8e6a36b9038.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, Nickel,7440-02-0," Value used for CSA: NOAEL (oral, systemic, animal data):0.011 mg Ni (as soluble ion)/kg bw/day (770 µg Ni/day for 70 kg person or 231 µg Ni/day of absorbed dose based on 30% absorption of Ni from water under fasting conditions) LOAEC (inhalation, local, animal data): 0.1 mg Ni/m³ air(powder MMAD=1.8μm, GSD=2.4; Oller et al, 2008) (Oral, local values are not applicable; Inhalation, systemic values are not applicable; Dermal, local or systemic, values are not applicable) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4077cd76-ccb2-49ca-88fb-061e09fb6eff/documents/7a087e73-ef1a-426f-97ec-9dd51a001bd7_1ffa5168-a8f9-4b6e-9ebf-11891e781a75.html,,,,,, Nickel,7440-02-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4077cd76-ccb2-49ca-88fb-061e09fb6eff/documents/7a087e73-ef1a-426f-97ec-9dd51a001bd7_1ffa5168-a8f9-4b6e-9ebf-11891e781a75.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,0.1 mg/m3,, Nickel,7440-02-0," Values used for CSA: NOAEL (oral, systemic, animal data): > 9000 mg Ni/kg bw (FDRL, 1983) NOAEL (oral, systemic, human data): 0.012 mg Ni (Ni ion)/kg bw/day released from metallic nickel in water and food contact material (Nielsen et al 1999) NOAEC (inhalation, systemic, animal data): ≥10200 mg Ni/m3 air (FDRL, 1985). - An acute systemic inhalation DNEL is not derived for nickel metal since acute systemic toxicity is so low that the substance does not merit classification for this health endpoint. LOAEC (inhalation, local, animal data): 4 mg Ni/m3 (MMAD = 1.5 µm) (DNEL calculation is based on 28-day repeated dose study-WIL Research Laboratories, 2002; no acute data available) - An acute local inhalation DNEL is derived based on the lung effects (e.g. lung inflammation) associated with nickel metal inhalation. The shortest-term study available examining those effects in animals is a 28-day repeated exposure study. An adjustment factor was derived to extrapolate the results from the repeated exposure study to an equivalent effect concentration in a 4 hr acute exposure. See Appendix C3 for more information. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4077cd76-ccb2-49ca-88fb-061e09fb6eff/documents/6d077df2-db46-4c5a-a481-d6fda312c7b7_1ffa5168-a8f9-4b6e-9ebf-11891e781a75.html,,,,,, "2-chlorobuta-1,3-diene",126-99-8,"The critical local effects following chronic inhalation exposures to chloroprene are considered to be non-neoplastic lesions of the nose and the lungs. In 2-year chronic inhalation bioassays conducted by NTP (1998), the incidence of non-neoplastic lesions of the lungs (bronchiolar hyperplasia or alveolar epithelia hyperplasia) and of the nose (chronic inflammation; atrophy or necrosis) were statistically increased in mice and rats treated at the lowest exposure concentration in the study (12.8 ppm). A No-Observed-Adverse-Effect-Concentration (NOAEC) was not established in these studies. Concerning neoplastic observations see chapter carcinogenicity.Additionally repeated dose inhalation toxicity of chloroprene has been investigated in rats, mice and hamsters in different subacute and subchronic studies. In repeated dose toxicity studies conducted by NTP (1998) male and female F344/N rats and B6C3F1 mice were exposed to chloroprene (>96% pure) by inhalation at concentrations between 12 and 200 ppm for 16 days or 13 weeks. The LOAEL for the sub-acute inhalation toxicity of chloroprene in rats was 32 ppm (115.8 mg/m3) based on degeneration of the olfactory epithelium. The NOAEL for sub-acute inhalation toxicity of chloroprene in mice was 12 ppm (43.4 mg/m) based on observations of decreased bodyweight gains in the consecutively higher dose group. A NOAEL of 12 ppm (43.4 mg/m3) was proposed for the sub-chronic inhalation toxicity of chloroprene in rats based on observation of olfactory epithelial degeneration at 32 ppm. NOAELs of 32 (115.8 mg/m3) and 12 ppm (43.4 mg/m3) were proposed for the sub-chronic inhalation toxicity of chloroprene in male and female mice respectively based on observations of squamous epithelial hyperplasia and anaemia at higher doses respespectively. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03e9d2bb-c675-455d-baf7-8e9512c5c6f3/documents/IUC5-582ebb9b-f7e8-4cb9-8fa2-ff003c7951e1_319e4d2b-bfed-4045-b095-4f46ad879f95.html,,,,,, "2-chlorobuta-1,3-diene",126-99-8,"Acute investigations are available for oral and inhalation routes of exposure and some limited data are available for acute topical exposure. For Chloroprene an oral LD50 value of 251 mg/kg bw in rats was determined (Asmamgulian 1971). For the endpoint acute toxicity: inhalation formal median lethal dose levels were not established in compliance with current test procedures but lethal dose levels have been identified using alternative evaluative methods ((Anon 1970, 1971, 1974 and Plugge1979). Data from secondary litertature indicate an LC50 of 11800 mg/m3/4h in rats Izmerov 1982).In a limited dermal toxicity study no mortality was observed after single dermal exposure with 200 mg/kg bw (Anon 1970). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03e9d2bb-c675-455d-baf7-8e9512c5c6f3/documents/IUC5-1658e2bd-e855-46f0-931f-cc62396d210d_319e4d2b-bfed-4045-b095-4f46ad879f95.html,,,,,, "2-chlorobuta-1,3-diene",126-99-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03e9d2bb-c675-455d-baf7-8e9512c5c6f3/documents/IUC5-1658e2bd-e855-46f0-931f-cc62396d210d_319e4d2b-bfed-4045-b095-4f46ad879f95.html,,oral,LD50,251 mg/kg bw,, "Distillates (petroleum), solvent-dewaxed heavy paraffinic",64742-65-0,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEC (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3. The 90-day dermal studies gave a sub-chronic NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils, and a NOAEL of less than 30 mg/kg for insufficiently refined other lubricant base oils.  A subchronic oral toxicity NOAEL of <125 mg/kg/day was determined for insufficiently refined other lubricant base oils using read-across to a 90-day subchronic toxicity study an untreated distillate aromatic extreact. Sufficiently refined other lubricant baseoils are not classified according to CLP for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca878849-4add-4e21-a218-cb3f78019b6c/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_b70d5d6c-78f1-4e21-aae0-cf3e2fc28884.html,,,,,, "Distillates (petroleum), solvent-dewaxed heavy paraffinic",64742-65-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca878849-4add-4e21-a218-cb3f78019b6c/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_b70d5d6c-78f1-4e21-aae0-cf3e2fc28884.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980 mg/m3,,rat "Distillates (petroleum), solvent-dewaxed heavy paraffinic",64742-65-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca878849-4add-4e21-a218-cb3f78019b6c/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_b70d5d6c-78f1-4e21-aae0-cf3e2fc28884.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Distillates (petroleum), solvent-dewaxed heavy paraffinic",64742-65-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca878849-4add-4e21-a218-cb3f78019b6c/documents/fda7b3fe-b688-42e6-ba29-6abeb331fa72_b70d5d6c-78f1-4e21-aae0-cf3e2fc28884.html,Chronic toxicity – systemic effects,dermal,LOAEL,100 mg/kg bw/day,,mouse "Distillates (petroleum), solvent-dewaxed heavy paraffinic",64742-65-0,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rats was evaluated in two key studies (API, 1982a and API, 1986a) by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥  3%) in male and female rabbits was evaluated in two key studies (API, 1982a and API, 1986a) at doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg and ""insufficiently refined"" is >2000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3% and IP 346 ≥ 3%) in male and female rats was evaluated in two key studies (Exxon Biomedical Sciences, Inc, 1988a and API, 1987a) and an aerosol concentration of 5mg/L. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. Based on the weight of evidence, the acute inhalation LC50 for the other lubricant base oil category is conidered to be >5.0 mg/L. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca878849-4add-4e21-a218-cb3f78019b6c/documents/73761dae-46d6-428e-8e40-e5cc70088d96_b70d5d6c-78f1-4e21-aae0-cf3e2fc28884.html,,,,,, "Distillates (petroleum), solvent-dewaxed heavy paraffinic",64742-65-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca878849-4add-4e21-a218-cb3f78019b6c/documents/73761dae-46d6-428e-8e40-e5cc70088d96_b70d5d6c-78f1-4e21-aae0-cf3e2fc28884.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), solvent-dewaxed heavy paraffinic",64742-65-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca878849-4add-4e21-a218-cb3f78019b6c/documents/73761dae-46d6-428e-8e40-e5cc70088d96_b70d5d6c-78f1-4e21-aae0-cf3e2fc28884.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), solvent-dewaxed heavy paraffinic",64742-65-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca878849-4add-4e21-a218-cb3f78019b6c/documents/73761dae-46d6-428e-8e40-e5cc70088d96_b70d5d6c-78f1-4e21-aae0-cf3e2fc28884.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Extracts (petroleum), light paraffinic distillate solvent",64742-05-8,"NOAEL for heavy paraffinic distillate aromatic extract could not be identified in a 90-day oral study (equivalent to OECD 408) and is less than 125 mg/kg/day when administered orally to male rats.  Systemic toxicity was observed in a 90-day dermal study (equivalent to OECD 411) in rats exposed to heavy paraffinic DAE (CAS number 64742-04-7).  A NOAEL could not be established since toxicity was observed at all dosing levels, including the lowest dose tested. The authors considered the NOAEL for dermal exposure to be less than 30 mg/kg/day.  In a 28-day dermal study (equivalent to OECD 410), no signs of systemic toxicity were observed in rabbits even at the high dose, 1000 mg/kg/day.   ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c99b4b2f-f163-4ad8-a82f-b24fb84ece25/documents/7bbda247-3440-4298-a989-84c2d1a494ff_0337bf3c-5bd5-48e9-bbf5-ecafe1d91f02.html,,,,,, "Extracts (petroleum), light paraffinic distillate solvent",64742-05-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c99b4b2f-f163-4ad8-a82f-b24fb84ece25/documents/7bbda247-3440-4298-a989-84c2d1a494ff_0337bf3c-5bd5-48e9-bbf5-ecafe1d91f02.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,125 mg/kg bw/day,,rat "Extracts (petroleum), light paraffinic distillate solvent",64742-05-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c99b4b2f-f163-4ad8-a82f-b24fb84ece25/documents/7bbda247-3440-4298-a989-84c2d1a494ff_0337bf3c-5bd5-48e9-bbf5-ecafe1d91f02.html,Sub-chronic toxicity – systemic effects,dermal,LOAEL,30 mg/kg bw/day,,rat "Extracts (petroleum), light paraffinic distillate solvent",64742-05-8,"Key acute oral (similar to OECD 401), dermal (similar to OECD 402), and inhalation (OECD 403)  toxicity studies (OECD 420) were identified.• The oral LD50 was > 5000 mg/kg bw in male and female rats for light paraffinic DAE.• The inhalation LC50 was > 5 mg/L for DAE.• The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for light paraffinic DAE. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c99b4b2f-f163-4ad8-a82f-b24fb84ece25/documents/49623972-9bec-41a1-849e-1214cef6d1d9_0337bf3c-5bd5-48e9-bbf5-ecafe1d91f02.html,,,,,, "Extracts (petroleum), light paraffinic distillate solvent",64742-05-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c99b4b2f-f163-4ad8-a82f-b24fb84ece25/documents/49623972-9bec-41a1-849e-1214cef6d1d9_0337bf3c-5bd5-48e9-bbf5-ecafe1d91f02.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Extracts (petroleum), light paraffinic distillate solvent",64742-05-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c99b4b2f-f163-4ad8-a82f-b24fb84ece25/documents/49623972-9bec-41a1-849e-1214cef6d1d9_0337bf3c-5bd5-48e9-bbf5-ecafe1d91f02.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Extracts (petroleum), light paraffinic distillate solvent",64742-05-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c99b4b2f-f163-4ad8-a82f-b24fb84ece25/documents/49623972-9bec-41a1-849e-1214cef6d1d9_0337bf3c-5bd5-48e9-bbf5-ecafe1d91f02.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "4,4'-methylenedianiline",101-77-9," The key study for repeated oral toxicity was performed similar to OECD TG 408 (BASF SE, 1982). Young adult male and female rats were treated with the test substance orally via the drinking water. A LOAEL of 7.5 mg/kg bw/d was determined based on changes in the thyroid in male and female animals at the lowest dose level (slight stimulation of the thyroidal follicular epithelium). Target organ systems were liver, thyroid and the urinary system. The analysis of hematology parameters revealed treatment-related anemia in both sexes. The histopathological findings in the liver were accompanied by elevated serum levels of liver specific enzymes and other parameters related to hepatotoxicity. The test report is supported by two studies (NTP, 1983) performed similar to OECD TG 408 in young adult rats (male/female) or adult mice, respectively. After 90 d repeated dosing a NOAEL of 7.1 mg/kg bw/d was determined in rats and a NOAEL of 11.4 mg/kg bw/d was determined in mice. In both species, target organs were the hepatobiliary system and the thyroid system, the latter being more pronounced in the rat. Chronic toxicity study data in rats and mice are summarized in endpoint section 7.7 (Carcinogenicity). These data revealed histopathological findings in the liver and thyroid of both species, with rats being more sensitive than mice (NTP, 1983). Additional study information is available for repeated oral dosing in rats (Gohlke et al., 1978; Tullner et al., 1966; Dow Chemical Company, 1955; Miyamoto et al., 1977; Pludro et al., 1969; Fukushima et al., 1979), cats (Hofmann et al., 1966) and dogs (Deichmann et al., 1978; Dow Chemical Company, 1955). The outcome of these subacute and subchronic studies corroborate the findings of the key study. For inhalative toxicity only a short-term toxicity study in male guinea-pigs was available with limited reliability (only one concentration was applied) and confirming the systemic toxicity of the test substance (Leong et al., 1987). All animals showed degeneration of the retina. No treatment related alterations in liver and kidney tissue were observed. The key study for repeated dermal toxicity was performed similar to OECD TG 411 (Huntsman Polyurethanes, 1998). Young adult male and female rats were treated with the test substance under occlusive conditions. A NO(A)EL of 90 mg/kg bw/d was determined. No treatment related systemic toxicity and no target organ systems were spotted. The outcome of the key study was supported by the 21 d repeated dermal dosing study in rats (Huntsman Polyurethanes, 1997). Additional study information for repeated dermal dosing in other species is available. The 14 d dermal dosing of mice (Oak Ridge National Laboratory, 1987) showed test substance related mortality and changes in organ weights (spleen, liver). Repeated dermal dosing of rabbits (10 days) did not reveal any relevant changes in clinical chemistry parameter, organ weights or histopathology (Haskell Laboratory, 1975). ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/906aa46f-24dc-4052-b87b-853e42b7f600/documents/IUC5-ef1ff866-9440-4810-88da-788c4e3d7ad1_13b7d67a-52e5-4570-9b63-d64256eb3e25.html,,,,,, "4,4'-methylenedianiline",101-77-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/906aa46f-24dc-4052-b87b-853e42b7f600/documents/IUC5-ef1ff866-9440-4810-88da-788c4e3d7ad1_13b7d67a-52e5-4570-9b63-d64256eb3e25.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,7.5 mg/kg bw/day,,rat "4,4'-methylenedianiline",101-77-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/906aa46f-24dc-4052-b87b-853e42b7f600/documents/IUC5-ef1ff866-9440-4810-88da-788c4e3d7ad1_13b7d67a-52e5-4570-9b63-d64256eb3e25.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,90 mg/kg bw/day,,rat "4,4'-methylenedianiline",101-77-9," Acute oral LD50 in rats 444 mg/kg bw, in cats and dogs between 50-100 mg/kg bw.  Acute dermal LD50 in rats >2000 mg/kg bw (no assay in other species available).  No mortality was observed in rats and cats with highest technically feasible and respirable inhalation atmosphere. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/906aa46f-24dc-4052-b87b-853e42b7f600/documents/IUC5-e42a9640-c0a9-4708-ab6b-961dde1af315_13b7d67a-52e5-4570-9b63-d64256eb3e25.html,,,,,, "4,4'-methylenedianiline",101-77-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/906aa46f-24dc-4052-b87b-853e42b7f600/documents/IUC5-e42a9640-c0a9-4708-ab6b-961dde1af315_13b7d67a-52e5-4570-9b63-d64256eb3e25.html,,dermal,LD50,"2,080 mg/kg bw",no adverse effect observed, "Residues (petroleum), catalytic cracking",92061-97-7," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ffe37dc-d6b2-47ac-b52d-50bc0c5076dd/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_efb19934-7dae-4957-80b7-5812c37dbbae.html,,,,,, "Residues (petroleum), catalytic cracking",92061-97-7,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ffe37dc-d6b2-47ac-b52d-50bc0c5076dd/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_efb19934-7dae-4957-80b7-5812c37dbbae.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Residues (petroleum), catalytic cracking",92061-97-7,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ffe37dc-d6b2-47ac-b52d-50bc0c5076dd/documents/12190120-6b6e-49c5-bed7-264eab246437_efb19934-7dae-4957-80b7-5812c37dbbae.html,,,,,, "Residues (petroleum), catalytic cracking",92061-97-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ffe37dc-d6b2-47ac-b52d-50bc0c5076dd/documents/12190120-6b6e-49c5-bed7-264eab246437_efb19934-7dae-4957-80b7-5812c37dbbae.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Residues (petroleum), catalytic cracking",92061-97-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ffe37dc-d6b2-47ac-b52d-50bc0c5076dd/documents/12190120-6b6e-49c5-bed7-264eab246437_efb19934-7dae-4957-80b7-5812c37dbbae.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), catalytic cracking",92061-97-7,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ffe37dc-d6b2-47ac-b52d-50bc0c5076dd/documents/12190120-6b6e-49c5-bed7-264eab246437_efb19934-7dae-4957-80b7-5812c37dbbae.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "Residues (petroleum), heavy coker gas oil and vacuum gas oil",68478-17-1," No data on the oral and inhalation are available or required given that the dermal route is the most plausible route of exposure to Heavy Fuel Oil Components. Changes in haematological and clinical chemistry parameters and organ weight/s have been reported post dermal exposure to Heavy Fuel Oil Components. In general, alterations in serum cholesterol and blood urea nitrogen were recorded following administration of higher dermal doses accompanied by red cell, platelet, liver and thymus effects at lower treatment levels. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5be09d6-1a64-40af-b3df-9851dcdc3b04/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_83dbebfe-df58-4cf2-ace3-68be457a5006.html,,,,,, "Residues (petroleum), heavy coker gas oil and vacuum gas oil",68478-17-1,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5be09d6-1a64-40af-b3df-9851dcdc3b04/documents/05656916-adbd-4432-b48b-aa81cff3cc3a_83dbebfe-df58-4cf2-ace3-68be457a5006.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,1.06 mg/kg bw/day,,rat "Residues (petroleum), heavy coker gas oil and vacuum gas oil",68478-17-1,"Heavy Fuel Oil Components are of low intrinsic hazard following acute oral, dermal and inhalation exposure.-The acute oral LD50 was determined to be 4320 mg/kg bw in female rats and 5270 mg/kg bw in male rats. - The acute inhalation LC50 was determined to be 4100 mg/m3 in rats.- The acute dermal LD50 in rabbits was determined to be >2000 mg/kg bw. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5be09d6-1a64-40af-b3df-9851dcdc3b04/documents/12190120-6b6e-49c5-bed7-264eab246437_83dbebfe-df58-4cf2-ace3-68be457a5006.html,,,,,, "Residues (petroleum), heavy coker gas oil and vacuum gas oil",68478-17-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5be09d6-1a64-40af-b3df-9851dcdc3b04/documents/12190120-6b6e-49c5-bed7-264eab246437_83dbebfe-df58-4cf2-ace3-68be457a5006.html,,oral,LD50,"4,320 mg/kg bw",no adverse effect observed, "Residues (petroleum), heavy coker gas oil and vacuum gas oil",68478-17-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5be09d6-1a64-40af-b3df-9851dcdc3b04/documents/12190120-6b6e-49c5-bed7-264eab246437_83dbebfe-df58-4cf2-ace3-68be457a5006.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), heavy coker gas oil and vacuum gas oil",68478-17-1,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5be09d6-1a64-40af-b3df-9851dcdc3b04/documents/12190120-6b6e-49c5-bed7-264eab246437_83dbebfe-df58-4cf2-ace3-68be457a5006.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, Ziram,137-30-4,"Oral toxicity Key, report number ZIR 5/901840, subchronic (90 days, rat): NOAEL: No NOAEL could be set LOAEL (oral): 100 ppm corresponding to 7.4 mg/kg bw/day (males) and 8.8 mg/kg bw/day (females)   Key, report number ZIR 8-G/901813, subchronic (90 days, dog): NOAEL (oral): 100 ppm corresponding to 4.07 mg/kg bw/day (males) and 4.31 mg/kg bw/day (females)   Key, report number ZIR 10/920533, chronic (52 weeks, dog): NOAEL (oral): 50 ppm corresponding to 1.6 mg/kg bw/day (males) and 1.9 mg/kg bw/day (females)   Key, report number ZIR 9/942098, chronic/carcinogenicity (2 years, rat): NOAEL (general systemic toxicity, oral): No NOAEL could be set LOAEL (general systemic toxicity, oral): 60 ppm, corresponding to 2.5 mg/kg bw/day (males) and 3.4 mg/kg bw/day (females)   Key, report number 83-5121, chronic/carcinogenicity (2 years, rat): NOAEL (general systemic toxicity, oral): 16 ppm, corresponding to 0.56 and 0.66 mg/kg bw/day for males and females, respectively.   Inhalation toxicity Key, report number UCB 709/003932, subacute (28 days, rat, dust): NOAEC (respiratory system): 0.1 mg/m³ air (females, males) NOAEC (general systemic toxicity): 3 mg/m³ air (females, males)   Dermal toxicity Key, report number ZIR 4/89689, subacute (21 days, rat, occlusive): NOAEL (local, dermal): 1000 mg/kg bw/day (females, males) and corresponding to approx. 11.81 mg/cm² NOAEL (general systemic toxicity, dermal): 100 mg/kg bw/day (females, males) ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ea7d0f1-daa8-4682-a0e4-df7c2bb3a433/documents/IUC5-7fd4cd24-d7a3-4ea1-a854-a219086090d2_8d6ef61d-e6ea-4a41-8c9f-ecfc630b875b.html,,,,,, Ziram,137-30-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ea7d0f1-daa8-4682-a0e4-df7c2bb3a433/documents/IUC5-7fd4cd24-d7a3-4ea1-a854-a219086090d2_8d6ef61d-e6ea-4a41-8c9f-ecfc630b875b.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,,rabbit Ziram,137-30-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ea7d0f1-daa8-4682-a0e4-df7c2bb3a433/documents/IUC5-7fd4cd24-d7a3-4ea1-a854-a219086090d2_8d6ef61d-e6ea-4a41-8c9f-ecfc630b875b.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,3 mg/m3,,rat Ziram,137-30-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ea7d0f1-daa8-4682-a0e4-df7c2bb3a433/documents/IUC5-7fd4cd24-d7a3-4ea1-a854-a219086090d2_8d6ef61d-e6ea-4a41-8c9f-ecfc630b875b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,1.6 mg/kg bw/day,,dog Ziram,137-30-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ea7d0f1-daa8-4682-a0e4-df7c2bb3a433/documents/IUC5-7fd4cd24-d7a3-4ea1-a854-a219086090d2_8d6ef61d-e6ea-4a41-8c9f-ecfc630b875b.html,Chronic toxicity – systemic effects,oral,NOAEL,0.56 mg/kg bw/day,,rat Ziram,137-30-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ea7d0f1-daa8-4682-a0e4-df7c2bb3a433/documents/IUC5-7fd4cd24-d7a3-4ea1-a854-a219086090d2_8d6ef61d-e6ea-4a41-8c9f-ecfc630b875b.html,Repeated dose toxicity – local effects,dermal,NOAEL,11.81 mg/cm2,no adverse effect observed,rabbit Ziram,137-30-4,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ea7d0f1-daa8-4682-a0e4-df7c2bb3a433/documents/IUC5-7fd4cd24-d7a3-4ea1-a854-a219086090d2_8d6ef61d-e6ea-4a41-8c9f-ecfc630b875b.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.1 mg/m3,adverse effect observed,rat Ziram,137-30-4,"Oral Key, report number HRC 89690/UCB 315/AC, (rat): LD50 = 267 mg/kg bw (females) and 381 (males)   Inhalation Key, report number UCB 314/89684 (rat): LC50 = 0.08 mg/L (males) and 0.06 mg/L (female) Key, report number 378/2, (rat): LC50 = 0.18 mg/L (males) and 0.08 mg/L (females) Dermal Key, report number HRC 89338D/UCB 316/AC (rabbit): LD50 > 2000 mg/kg bw (males and females)   ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ea7d0f1-daa8-4682-a0e4-df7c2bb3a433/documents/IUC5-48c411e9-4844-43cb-b89f-e4e8a7f43712_8d6ef61d-e6ea-4a41-8c9f-ecfc630b875b.html,,,,,, Ziram,137-30-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ea7d0f1-daa8-4682-a0e4-df7c2bb3a433/documents/IUC5-48c411e9-4844-43cb-b89f-e4e8a7f43712_8d6ef61d-e6ea-4a41-8c9f-ecfc630b875b.html,,oral,LD50,267 mg/kg bw,adverse effect observed, Ziram,137-30-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ea7d0f1-daa8-4682-a0e4-df7c2bb3a433/documents/IUC5-48c411e9-4844-43cb-b89f-e4e8a7f43712_8d6ef61d-e6ea-4a41-8c9f-ecfc630b875b.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Ziram,137-30-4,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ea7d0f1-daa8-4682-a0e4-df7c2bb3a433/documents/IUC5-48c411e9-4844-43cb-b89f-e4e8a7f43712_8d6ef61d-e6ea-4a41-8c9f-ecfc630b875b.html,,inhalation,LC50,0.06 mg/L,adverse effect observed, Propargite,2312-35-8,ORAL The NOAEL was determined to be 7.1 mg/kg bw/day (males) and 8.3 mg/kg/day (females) according to a 13 week rat study performed in line with EPA Guideline 82-1. The NOAEL was determined to be 4 mg/kg bw/day according to a 1 year dog study performed in line with a method considered to be equivalent to OECD 452. DERMAL The NOEL was determined to be >100 mg/kg bw/day according to a 21 day rabbit study performed in line with EPA Guideline 82-2. ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4422131b-114d-4111-87d0-2cc2ec19c4cf/documents/IUC5-2cc878be-1458-4392-be47-5145602ad714_c9152941-5ff7-4071-a9c7-46bef305c8d9.html,,,,,, Propargite,2312-35-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4422131b-114d-4111-87d0-2cc2ec19c4cf/documents/IUC5-2cc878be-1458-4392-be47-5145602ad714_c9152941-5ff7-4071-a9c7-46bef305c8d9.html,Chronic toxicity – systemic effects,oral,NOAEL,4 mg/kg bw/day,,dog Propargite,2312-35-8,"ORAL The LD50 for propargite was determined to be 2800 mg/kg bw according to a study performed in line with EPA OPP Guideline 81-1. INHALATION The LC50 for propargite was determined to be 0.89 mg/m3 according to a study performed in line with EPA OPP Guideline 81-3. In this study, the lowest concentration tested was 0.3 mg/L which caused marked effects including mortality. As the lowest concentration tested for inhalation, and with propargite known to be an irritant, this concentration is used as a LOEC for local irritant effects by inhalation. DERMAL The LD50 for propargite was determined to be > 4000 mg/kg bw according to a study performed in line with EPA OPP Guideline 81-2. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4422131b-114d-4111-87d0-2cc2ec19c4cf/documents/IUC5-93b32688-aab5-430c-bec3-45df02c6d404_c9152941-5ff7-4071-a9c7-46bef305c8d9.html,,,,,, Propargite,2312-35-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4422131b-114d-4111-87d0-2cc2ec19c4cf/documents/IUC5-93b32688-aab5-430c-bec3-45df02c6d404_c9152941-5ff7-4071-a9c7-46bef305c8d9.html,,oral,LD50,"2,800 mg/kg bw",no adverse effect observed, Propargite,2312-35-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4422131b-114d-4111-87d0-2cc2ec19c4cf/documents/IUC5-93b32688-aab5-430c-bec3-45df02c6d404_c9152941-5ff7-4071-a9c7-46bef305c8d9.html,,dermal,LD50,"4,000 mg/kg bw",no adverse effect observed, Propargite,2312-35-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4422131b-114d-4111-87d0-2cc2ec19c4cf/documents/IUC5-93b32688-aab5-430c-bec3-45df02c6d404_c9152941-5ff7-4071-a9c7-46bef305c8d9.html,,inhalation,LC50,0.89 mg/m3,adverse effect observed, Tetrylammonium bromide,71-91-0," Repeated dose toxicity: Oral From the observations of experimental study of repeated Dose 28-day toxicity by daily gavage followed by a 2 week recovery period, the NOAEL for the test chemical was considered to be 1000mg/kg in the male and female  Sprague Dawley rats. Repeated inhalation study: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance N, N, N-triethylethanaminium bromide(71-91-0) which is reported as 7.92E-07 mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical N, N, N-triethylethanaminium bromide is highly unlikely. Therefore this study is considered for waiver. Repeated dermal study; The acute toxicity value for N, N, N-triethylethanaminium bromide(71-91-0) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that N, N, N-triethylethanaminium bromide shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that N, N, N-triethylethanaminium bromide shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc6ccadf-e1ee-4781-87e0-3c7457431c3b/documents/3582a2b2-2581-460b-b14a-2180f3367b67_7a0d1535-de70-4251-b8db-3d7d15441071.html,,,,,, Tetrylammonium bromide,71-91-0,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc6ccadf-e1ee-4781-87e0-3c7457431c3b/documents/3582a2b2-2581-460b-b14a-2180f3367b67_7a0d1535-de70-4251-b8db-3d7d15441071.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tetrylammonium bromide,71-91-0," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is2800 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity.Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.  Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 1.056E-4 Pa (7.92E-07 mm Hg). Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The study concluded that the LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc6ccadf-e1ee-4781-87e0-3c7457431c3b/documents/b0931343-771d-4c16-93e9-68c98c6b4c64_7a0d1535-de70-4251-b8db-3d7d15441071.html,,,,,, Tetrylammonium bromide,71-91-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc6ccadf-e1ee-4781-87e0-3c7457431c3b/documents/b0931343-771d-4c16-93e9-68c98c6b4c64_7a0d1535-de70-4251-b8db-3d7d15441071.html,,oral,LD50,"2,800 mg/kg bw",no adverse effect observed, Tetrylammonium bromide,71-91-0,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc6ccadf-e1ee-4781-87e0-3c7457431c3b/documents/b0931343-771d-4c16-93e9-68c98c6b4c64_7a0d1535-de70-4251-b8db-3d7d15441071.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light steam-cracked naphtha",68475-80-9,"Repeated dose toxicity data are not available for Fuel Oils streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene - when present at 10%). The available data on the marker constituent DCPD do not reveal any specific target organ toxicity of a severity that would warrant classification. Therefore, no classification or labelling is warranted for streams which only contain these components. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/482ad81f-ce71-4f0c-b286-3b0d1d5088df/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_7924774a-c000-4e91-a12d-0fdbb6e2222b.html,,,,,, "Distillates (petroleum), light steam-cracked naphtha",68475-80-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/482ad81f-ce71-4f0c-b286-3b0d1d5088df/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_7924774a-c000-4e91-a12d-0fdbb6e2222b.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), light steam-cracked naphtha",68475-80-9,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/482ad81f-ce71-4f0c-b286-3b0d1d5088df/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_7924774a-c000-4e91-a12d-0fdbb6e2222b.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Distillates (petroleum), light steam-cracked naphtha",68475-80-9,"Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen.The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene.   Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene.   Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene. Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/482ad81f-ce71-4f0c-b286-3b0d1d5088df/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_7924774a-c000-4e91-a12d-0fdbb6e2222b.html,,,,,, "Distillates (petroleum), light steam-cracked naphtha",68475-80-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/482ad81f-ce71-4f0c-b286-3b0d1d5088df/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_7924774a-c000-4e91-a12d-0fdbb6e2222b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light steam-cracked naphtha",68475-80-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/482ad81f-ce71-4f0c-b286-3b0d1d5088df/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_7924774a-c000-4e91-a12d-0fdbb6e2222b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), light steam-cracked naphtha",68475-80-9,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/482ad81f-ce71-4f0c-b286-3b0d1d5088df/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_7924774a-c000-4e91-a12d-0fdbb6e2222b.html,,inhalation,LC50,"1,600 mg/m3",no adverse effect observed, (E)-anethole,4180-23-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d17bc4e5-fed0-4568-b5eb-357b6ade5511/documents/ef42a16e-e3af-4d49-a7f9-b4e107d4db4d_42eda21b-0ec2-402d-9d2d-87faa95dcec0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat p-menth-1-en-8-ol,98-55-5,"In the key study, a 20-week repeated dose toxicity test in rats, the NOAEL of alpha-Terpinyl Acetate is set to >=400 mg/kg bw/day (10,000 mg/kg.diet. This value can be converted to alpha-Terpineol becoming 314 mg/kg diet (154/196 x 400 mg/kg bw). ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2d8ad3e-5129-45c6-bf5a-210740d7ffcf/documents/IUC5-46728aef-ec35-40c7-86d9-fd9ae82bde40_8c659489-03b4-44df-84f3-3a605d341945.html,,,,,, p-menth-1-en-8-ol,98-55-5,"Acute oral and dermal toxicity studies were available for Terpineol multi, (a multi-constituent substance with alpha-Terpineol as its main constituent and gamma-Terpineol as the minor constituent) 4300 mg/kg bw and >2000 mg/kg bw (LD50), respectively. An LC50 value of 30100 mg/m3 was calculated for acute inhalation toxicity. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2d8ad3e-5129-45c6-bf5a-210740d7ffcf/documents/IUC5-549bdb7b-f713-4fa3-a83e-7bfddcb35062_8c659489-03b4-44df-84f3-3a605d341945.html,,,,,, "(1R,5R)-2,6,6-trimethylbicyclo[3.1.1]hept-2-ene",7785-70-8," Repeated dose toxicity: inhalation. Weight of evidence. Based on the experimental results obtained with the analogue substance alpha pinene, the inhalation 90d-LOEL in rats for d-alpha pinene was determined to be 25 ppm (ca. 140 mg/m3) based on increases of incidences of kidney lesions in male rats. Also, the inhalation 90d-LOEL in mice for d-alpha pinene was determined to be 100 ppm (ca. 560 mg/m3) based on the effects on transitional epithelium hyperplasia of the urinary bladder for males and females and decrease in sperm per cauda epididymis for males. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22e2b89b-e2d7-4e28-bf46-b8cfc0cb48c9/documents/9b48c6c0-6b41-41da-9918-7f626ab6fdaf_559099d9-f266-477b-b766-a57b1425f2e7.html,,,,,, "(1R,5R)-2,6,6-trimethylbicyclo[3.1.1]hept-2-ene",7785-70-8,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22e2b89b-e2d7-4e28-bf46-b8cfc0cb48c9/documents/9b48c6c0-6b41-41da-9918-7f626ab6fdaf_559099d9-f266-477b-b766-a57b1425f2e7.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,140 mg/m3,,rat "(1R,5R)-2,6,6-trimethylbicyclo[3.1.1]hept-2-ene",7785-70-8," Acute oral toxicity: Key study. Test method according to OECD 423, GLP study. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off may be considered to be 2500 mg/kg body weight by oral route in the rat. Acute inhalation toxicity: Data waiving (study scientifically not necessary): According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The information is provided for dermal route. Acute dermal toxicity: Key study. Test method according to OECD 402, GLP study. The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in rats. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22e2b89b-e2d7-4e28-bf46-b8cfc0cb48c9/documents/6ee9f878-928e-47e6-8c1b-d4b3943acb6a_559099d9-f266-477b-b766-a57b1425f2e7.html,,,,,, "(1R,5R)-2,6,6-trimethylbicyclo[3.1.1]hept-2-ene",7785-70-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22e2b89b-e2d7-4e28-bf46-b8cfc0cb48c9/documents/6ee9f878-928e-47e6-8c1b-d4b3943acb6a_559099d9-f266-477b-b766-a57b1425f2e7.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "(1R,5R)-2,6,6-trimethylbicyclo[3.1.1]hept-2-ene",7785-70-8,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22e2b89b-e2d7-4e28-bf46-b8cfc0cb48c9/documents/6ee9f878-928e-47e6-8c1b-d4b3943acb6a_559099d9-f266-477b-b766-a57b1425f2e7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Beryllium,7440-41-7,No studies on repeat exposure to Be metal exists. The publications referenced (three studies reliable) in this section are relevant due to long post-exposure observation period. These were included as they demonstrated the Be is very persistent in lung following inhalation. ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e39ba51b-47b9-4956-8a4b-dfc0582bcdf0/documents/IUC5-05b1ee7f-80a1-4667-a3d3-434c7c96ac17_b2076dc2-4da8-4842-8ef3-0034bce2a069.html,,,,,, Beryllium,7440-41-7,"- An up to date acute oral toxicity study is available that reports no toxicity at the maximum dose of 2000 mg/kg bw.- No studies on dermal toxicity are available.- A set of non-standard studies with single inhalation exposure are available, but not suitable for setting a LC50.- Only airborne exposures to soluble beryllium compounds are associated with acute beryllium disease. Exposure to beryllium metal has not been found to be associated with acute or short-term respiratory reactions. Eisenbud M. The Standard for Control of Chronic Beryllium Disease. Appl Occup Environ Hyg 13(1): 25–31 (1998). ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e39ba51b-47b9-4956-8a4b-dfc0582bcdf0/documents/IUC5-f03a04e4-f1dd-406d-8b35-86388199f372_b2076dc2-4da8-4842-8ef3-0034bce2a069.html,,,,,, dichloromethane; methylene chloride,75-09-2," No evidence of adverse effects on health has been found at the workplace following occupational exposure concentrations of about 100 ppm DCM (353 mg/m3) over several years. Therefore, 100 ppm (353 mg/m3) is considered to be a clear no-observed-adverse-effect concentration for repeated dose toxicity of dichloromethane in humans. This concentration is also set as 8 h TWA by the SCOEL. Experimental inhalation studies in rats appear consistent with this figure (NOAEC of 706 mg/m3). Regarding the oral route of exposure a chronic NOAEL of 6 mg/kg bw/day based on liver effects (LOAEL of 52 mg/kg bw/day) in rats is selected as most critical one. ",2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eab8b08d-9c83-45c0-ad24-fa66de453701/documents/IUC5-32a03636-1b18-4a46-8408-a8ce044ec2bb_fa44f2b5-b851-4ab2-ba4b-264367f1f131.html,,,,,, dichloromethane; methylene chloride,75-09-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eab8b08d-9c83-45c0-ad24-fa66de453701/documents/IUC5-32a03636-1b18-4a46-8408-a8ce044ec2bb_fa44f2b5-b851-4ab2-ba4b-264367f1f131.html,Chronic toxicity – systemic effects,oral,NOAEL,6 mg/kg bw/day,,rat dichloromethane; methylene chloride,75-09-2,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eab8b08d-9c83-45c0-ad24-fa66de453701/documents/IUC5-32a03636-1b18-4a46-8408-a8ce044ec2bb_fa44f2b5-b851-4ab2-ba4b-264367f1f131.html,Chronic toxicity – systemic effects,inhalation,NOAEC,695 mg/m3,,rat dichloromethane; methylene chloride,75-09-2,"The available oral and dermal LD50 values and the calculated 4-h inhalation LC50 value of DCM are all above the classification cut-offs. In rats, administration of 2000 mg/kg bw did not induce mortality, either via the oral or the dermal route. In the mouse, an inhalation 7-hour LC50 value of 49000 mg/m3 has been reported which was recalculated into a 4-h LC50 value of 86000 mg/m3 taking Haber’s rule into account. The oral and dermal LD50 values and the inhalation LC50 values indicate that the acute toxicity of dichloromethane is low. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eab8b08d-9c83-45c0-ad24-fa66de453701/documents/IUC5-de1a5e2d-6199-41ff-850c-8dc8e8c7b0f6_fa44f2b5-b851-4ab2-ba4b-264367f1f131.html,,,,,, dichloromethane; methylene chloride,75-09-2,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eab8b08d-9c83-45c0-ad24-fa66de453701/documents/IUC5-de1a5e2d-6199-41ff-850c-8dc8e8c7b0f6_fa44f2b5-b851-4ab2-ba4b-264367f1f131.html,,inhalation,LC50,"49,000 mg/m3",no adverse effect observed, Hydrogen fluoride,7664-39-3,Comprehensive repeated dose oral toxicity data are available for sodium fluoride; read-across is therefore proposed. ,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/003e7155-ba29-4daa-b42c-0ee7bf24238f/documents/IUC5-2fa84c42-d4c2-4ad4-9fdf-00fe23aa79b9_8586705b-b970-4617-babb-80db64bd594c.html,,,,,, Hydrogen fluoride,7664-39-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/003e7155-ba29-4daa-b42c-0ee7bf24238f/documents/IUC5-2fa84c42-d4c2-4ad4-9fdf-00fe23aa79b9_8586705b-b970-4617-babb-80db64bd594c.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,0.72 mg/m3,,rat Hydrogen fluoride,7664-39-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/003e7155-ba29-4daa-b42c-0ee7bf24238f/documents/IUC5-2fa84c42-d4c2-4ad4-9fdf-00fe23aa79b9_8586705b-b970-4617-babb-80db64bd594c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 ,,rat Hydrogen fluoride,7664-39-3,,2025-01-24,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/003e7155-ba29-4daa-b42c-0ee7bf24238f/documents/IUC5-2fa84c42-d4c2-4ad4-9fdf-00fe23aa79b9_8586705b-b970-4617-babb-80db64bd594c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.72 mg/m3,adverse effect observed,rat Hydrogen fluoride,7664-39-3,"Waivers are appropriate for acute oral, dermal and inhalation toxicity as HF is a corrosive substance. No acute oral toxicity data are available. However, several non-standard acute inhalation toxicity studies are available. ",2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/003e7155-ba29-4daa-b42c-0ee7bf24238f/documents/IUC5-4ef522c2-1929-4b6b-b08d-654b5138f393_8586705b-b970-4617-babb-80db64bd594c.html,,,,,, Hydrogen fluoride,7664-39-3,,2025-01-24,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/003e7155-ba29-4daa-b42c-0ee7bf24238f/documents/IUC5-4ef522c2-1929-4b6b-b08d-654b5138f393_8586705b-b970-4617-babb-80db64bd594c.html,,inhalation,LC50,"2,240 ",adverse effect observed, (+)-2-amino-1-butanol,5856-62-2," No data is availble on the substance (d-2-AMINO-1-BUTANOL) - CAS: 5856-62-2. An LD50 oral mouse of 2300 mg/kg is reported for the substance 2-AMINO-1-BUTANOL (racemic mixture) - CAS: 96 -20 -8 . Reference: ""Novye Dannye Po Toksikologii Redkikh Metalov Ikh Soedinenii,"" New Data on the Toxicology of Rare Metals and Their Compounds, Izrael'son, Z.I., ed., Moscow, Izdatel'stvo ""Meditsina,"" 196Vol. -, Pg. -, 1967. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51c9980b-aed3-471f-9bb4-54889f51c1d5/documents/2e8d9d49-f1c5-4ca6-8620-69a04cebd2e8_ed4e9ef6-b292-45b2-a732-c8f9f50d19aa.html,,,,,, (+)-neomenthol,2216-52-6," Repeated dose oral: NOAEL was considered to be 600 mg/kg bw when treated with test material orally. Thus, comparing this value with the criteria of CLP regulation (+)-neomenthol is likely to be not classify as repeated dose oral toxicity. Repeated dose inhalation toxicity: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance Reaction mass of (+)-neomenthol (CAS no 2216-52-6), which is reported as 7.67E-03 mm Hg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical Reaction mass of (+)-neomenthol is highly unlikely. Therefore this study is considered for waiver.   Repeated dose dermal toxicity: In accordance with coloumn 2 of Annex IX, this end point was considered for waiver since the acute toxicity by the dermal route has already been provided in section 7.2.3 (as part of the Annex VIII information requirements) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cafcdb4c-4979-4e70-b9cc-c06f2c59961e/documents/50940201-2118-4855-9b68-bd61af79c74f_1a9bd32e-c933-49a3-891f-547d713bc357.html,,,,,, (+)-neomenthol,2216-52-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cafcdb4c-4979-4e70-b9cc-c06f2c59961e/documents/50940201-2118-4855-9b68-bd61af79c74f_1a9bd32e-c933-49a3-891f-547d713bc357.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat (+)-neomenthol,2216-52-6," Acute oral Toxicity:  The acute oral toxicity dose (LD50) for target chemical (+)-Neomenthol (CAS no: 2216-52-6) was estimated based on QSAR prediction done using the Danish (Q)SAR Database. The LD50 values were estimated to be 2800 mg/kg bw in rats and 3000 mg/kg bw in mice. The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, (+)-Neomenthol cannot be classified for acute oral toxicity.  Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure of humans via inhalation route is not likely taking into account due to the low vapour pressure of the substance (+)-Neomenthol (CAS no: 2216-52-6), which is reported to be 7.67E-03 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical (+)-Neomenthol is highly unlikely. Therefore this study is considered for waiver.   Acute dermal Toxicity:  The acute dermal toxicity dose (LD50) for (+)-Neomenthol (CAS no: 2216-52-6) was considered based on data available for the structurally and functionally similar read across chemicals. The LD50 value is >5000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, (+)-Neomenthol cannot be classified for acute dermal toxicity.  ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cafcdb4c-4979-4e70-b9cc-c06f2c59961e/documents/a54b2af0-039b-4ce9-a83c-bea7cf606575_1a9bd32e-c933-49a3-891f-547d713bc357.html,,,,,, (+)-neomenthol,2216-52-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cafcdb4c-4979-4e70-b9cc-c06f2c59961e/documents/a54b2af0-039b-4ce9-a83c-bea7cf606575_1a9bd32e-c933-49a3-891f-547d713bc357.html,,oral,LD50,"2,800 mg/kg bw",no adverse effect observed, (+)-neomenthol,2216-52-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cafcdb4c-4979-4e70-b9cc-c06f2c59961e/documents/a54b2af0-039b-4ce9-a83c-bea7cf606575_1a9bd32e-c933-49a3-891f-547d713bc357.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "(±)-13-ethyl-3-methoxygona-1,3,5(10),8-tetraen-17-one",5941-92-4,"Acute toxicity: oral (rats, equivalent to OECD TG 423): LD50: > 2000 mg/kg bw A single oral administration of the test substance by gavage to male and female rats at the limit-dose of 2000 mg/kg was tolerated without mortalities, effects on body weight gain and gross pathological findings. Slight apathy was observed in one male and one female on the application day only. Equivalent to OECD TG 423 the oral LD50 of the test substance is therefore > 2000 mg/kg body weight. Acute toxicity: dermal (rats, equivalent to OECD TG 402): LD50: > 2000 mg/kg bw A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. Equivalent to OECD TG 402 the dermal LD50 of the test substance is therefore > 2000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5859fe6-ea74-48c6-80c6-f267db201df0/documents/IUC5-0daae1cb-58a9-4658-b026-8d92533ebd7a_bd6ba370-4734-4555-941a-e9ba385470ec.html,,,,,, "(±)-13-ethyl-3-methoxygona-1,3,5(10),8-tetraen-17-one",5941-92-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5859fe6-ea74-48c6-80c6-f267db201df0/documents/IUC5-0daae1cb-58a9-4658-b026-8d92533ebd7a_bd6ba370-4734-4555-941a-e9ba385470ec.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(±)-13-ethyl-3-methoxygona-1,3,5(10),8-tetraen-17-one",5941-92-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5859fe6-ea74-48c6-80c6-f267db201df0/documents/IUC5-0daae1cb-58a9-4658-b026-8d92533ebd7a_bd6ba370-4734-4555-941a-e9ba385470ec.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(±)-13-ethyl-3-methoxygona-2,5(10)-dien-17-one",6236-40-4,"Acute toxicity: oral (rats, equivalent to OECD TG 423): LD50: > 2000 mg/kg bw A single oral administration of the test substance by gavage to male and female rats at the limit-dose of 2000 mg/kg was tolerated without mortalities, effects on body weight gain and gross pathological findings. Equivalent to OECD TG 423 the oral LD50 of the test substance is therefore > 2000 mg/kg body weight. Acute toxicity: dermal (rats, equivalent to OECD TG 402): LD50: > 2000 mg/kg bw A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. Equivalent to OECD TG 402 the dermal LD50 of the test substance is therefore > 2000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48573560-00bc-437c-87f5-38d1eb1c5109/documents/IUC5-9acb63e4-c163-4e48-ba2b-a57c028faea0_a00bffa6-6e85-4a12-827b-9f5b2aab2943.html,,,,,, "(±)-13-ethyl-3-methoxygona-2,5(10)-dien-17-one",6236-40-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48573560-00bc-437c-87f5-38d1eb1c5109/documents/IUC5-9acb63e4-c163-4e48-ba2b-a57c028faea0_a00bffa6-6e85-4a12-827b-9f5b2aab2943.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(±)-13-ethyl-3-methoxygona-2,5(10)-dien-17-one",6236-40-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48573560-00bc-437c-87f5-38d1eb1c5109/documents/IUC5-9acb63e4-c163-4e48-ba2b-a57c028faea0_a00bffa6-6e85-4a12-827b-9f5b2aab2943.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(±)-13-ethyl-3-methoxygona-2,5(10)-dien-17β-ol",1038-28-4,"Acute toxicity: oral (rats, equivalent to OECD TG 423): LD50: > 2000 mg/kg bw A single oral administration of the test substance by gavage to male and female rats at the limit-dose of 2000 mg/kg was tolerated without mortalities, effects on body weight gain and gross pathological findings. Slight apathy was observed in one male and one female on the application day only. Equivalent to OECD TG 423 the oral LD50 of the test substance is therefore > 2000 mg/kg body weight. Acute toxicity: dermal (rats, equivalent to OECD TG 402): LD50: > 2000 mg/kg bw A single dermal administration of the test substance to male and female rats at the limit-dose 2000 mg/kg was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. Equivalent to OECD TG 402 the dermal LD50 of the test substance is therefore > 2000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cdb9d11c-26a7-417d-adf7-a7871c149534/documents/IUC5-180a9acb-4682-4aff-b343-5b5e4dc91859_910572c6-75c9-444d-8ec5-0c9c042b4a19.html,,,,,, "(±)-13-ethyl-3-methoxygona-2,5(10)-dien-17β-ol",1038-28-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cdb9d11c-26a7-417d-adf7-a7871c149534/documents/IUC5-180a9acb-4682-4aff-b343-5b5e4dc91859_910572c6-75c9-444d-8ec5-0c9c042b4a19.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(±)-13-ethyl-3-methoxygona-2,5(10)-dien-17β-ol",1038-28-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cdb9d11c-26a7-417d-adf7-a7871c149534/documents/IUC5-180a9acb-4682-4aff-b343-5b5e4dc91859_910572c6-75c9-444d-8ec5-0c9c042b4a19.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, (±)-2-(6-methoxy-2-naphthyl)propionic acid,26159-31-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6693c62b-eb3d-4c7b-b95e-51aa619c08e0/documents/IUC5-5f55f46d-c16a-4953-8759-93db3040d08d_1de7e738-180b-4ef6-aeaf-409a6ee9de11.html,,oral,LD50,534 mg/kg bw,adverse effect observed, (±)-menthone,1074-95-9," Repeated dose toxicity: oral The No Observed Adverse Effect Level (NOAEL) for 2-isopropyl-5-methylcyclohexanone (menthone) is found to be < 200 mg/Kg bw/day using SPF Wistar male and female rats and the low Observed adverse effect level (LOAEL) is found to be 200 mg/Kg bw/day. Repeated dose toxicity: inhalation A short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Repeated dose toxicity: dermal The acute dermal toxicity value for 2-isopropyl-5-methylcyclohexanone (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 2-isopropyl-5-methylcyclohexanone shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 2-isopropyl-5-methylcyclohexanone shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/29f8b432-86b4-4491-b1e0-37d572049dff/documents/44f70290-dbc9-44ed-b692-f3a2f5f7db57_a52cc647-1773-43ae-91d8-6279e12fbfab.html,,,,,, (±)-menthone,1074-95-9,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/29f8b432-86b4-4491-b1e0-37d572049dff/documents/44f70290-dbc9-44ed-b692-f3a2f5f7db57_a52cc647-1773-43ae-91d8-6279e12fbfab.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat (±)-menthone,1074-95-9," Acute toxicity: oral LD50 was considered to be 2432.88 mg/kg bw (2031.12 - 2923.92) when rats were treated with 2-isopropyl-5-methylcyclohexanone orally. Acute toxicity: inhalation The study need not be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Acute toxicity: dermal LD50 was considered to be > 5000 mg/kg bw when rabbits were treated with 2-isopropyl-5-methylcyclohexanone by dermal application.  ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29f8b432-86b4-4491-b1e0-37d572049dff/documents/29c96cc1-8f60-40f8-acfb-03bf62ddbfd0_a52cc647-1773-43ae-91d8-6279e12fbfab.html,,,,,, (±)-menthone,1074-95-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29f8b432-86b4-4491-b1e0-37d572049dff/documents/29c96cc1-8f60-40f8-acfb-03bf62ddbfd0_a52cc647-1773-43ae-91d8-6279e12fbfab.html,,oral,LD50,"2,432.88 mg/kg bw",no adverse effect observed, (±)-menthone,1074-95-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29f8b432-86b4-4491-b1e0-37d572049dff/documents/29c96cc1-8f60-40f8-acfb-03bf62ddbfd0_a52cc647-1773-43ae-91d8-6279e12fbfab.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "(1,1,3,3-tetramethyldisiloxane-1,3-diyl)dipropane-1,3-diyl dimethacrylate",18547-93-8," In the key acute oral toxicity study with 1,1,3,3-tetramethyldisiloxane-1,3-diyl)dipropane-1,3-diyl dimethacrylate, the reported LD50 value was greater than 2000 mg/kg bw (Eurofins, 2017). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95af5a1d-2406-4268-91f0-d3c04983ae4b/documents/03751adf-c4af-44f4-b241-992ff39391ec_cca261c6-74fc-4782-b931-0c7344be2642.html,,,,,, "(1,1,3,3-tetramethyldisiloxane-1,3-diyl)dipropane-1,3-diyl dimethacrylate",18547-93-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95af5a1d-2406-4268-91f0-d3c04983ae4b/documents/03751adf-c4af-44f4-b241-992ff39391ec_cca261c6-74fc-4782-b931-0c7344be2642.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(1,2-dimethylpropyl)-5-methyl-pyrazole-4-carboxylic acid",1872341-39-3," In a GLP-compliant acute toxic class method study (according to OECD Guideline 423) the test substance was administered orally by gavage at doses of 300 and 2000 mg/kg bw to groups of 3 female rats, respectively. One animal died in one of the two 2000 mg/kg bw dose groups. No further adverse effects occurred during the observation period of 14 days. The oral LD50 was therefore determined to be > 2000 mg/kg bw for female rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d1b34ea-b35a-4f1a-ae85-345dd6a7e8fa/documents/3930b1c7-300a-4212-92f0-b33de59cbae4_02576474-64cc-468f-99ab-363d29136013.html,,,,,, "(1,2-dimethylpropyl)-5-methyl-pyrazole-4-carboxylic acid",1872341-39-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d1b34ea-b35a-4f1a-ae85-345dd6a7e8fa/documents/3930b1c7-300a-4212-92f0-b33de59cbae4_02576474-64cc-468f-99ab-363d29136013.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, "(1,2-dioxoethylene)bis(iminoethylene) bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]",70331-94-1," Repeated Dose Toxicity Oral - 90 day Rat: NOEL >20000 mg/kg in diet Repeated Dose Toxicity Oral - 14 day Dog: NOEL 150,000 ppm in the diet. Repated Dose Toxicity Oral - 90 day Dog: NOEL >20,000 ppm in the diet. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97f646d4-4039-4a73-ac1e-534168bca40b/documents/IUC5-58b476cb-3787-4b92-a8a9-b7fea49d471c_bb47306d-35f4-4f07-956d-4c5ffbb295ca.html,,,,,, "(1,2-dioxoethylene)bis(iminoethylene) bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]",70331-94-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97f646d4-4039-4a73-ac1e-534168bca40b/documents/IUC5-58b476cb-3787-4b92-a8a9-b7fea49d471c_bb47306d-35f4-4f07-956d-4c5ffbb295ca.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"20,000 mg/kg bw/day",,rat "(1,2-dioxoethylene)bis(iminoethylene) bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]",70331-94-1, Acute Oral Toxicity: LD50 >10 g/kg in Sprague Dawley rats Acute Inhalation Toxicity: LC50 >5.01 mg/L in Wistar Crl:WI rats ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97f646d4-4039-4a73-ac1e-534168bca40b/documents/IUC5-c0ee8487-c16d-4417-b0db-75ad751f3dc7_bb47306d-35f4-4f07-956d-4c5ffbb295ca.html,,,,,, "(1,2-dioxoethylene)bis(iminoethylene) bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]",70331-94-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97f646d4-4039-4a73-ac1e-534168bca40b/documents/IUC5-c0ee8487-c16d-4417-b0db-75ad751f3dc7_bb47306d-35f4-4f07-956d-4c5ffbb295ca.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "(1,2-dioxoethylene)bis(iminoethylene) bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]",70331-94-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97f646d4-4039-4a73-ac1e-534168bca40b/documents/IUC5-c0ee8487-c16d-4417-b0db-75ad751f3dc7_bb47306d-35f4-4f07-956d-4c5ffbb295ca.html,,inhalation,LC50,5.01 mg/m3,no adverse effect observed, "(1,4,5,6-tetrahydro-4,6-dioxopyrimidin-2-yl)cyanamide",55067-10-2," A study was performed to assess the acute oral toxicity of the (1,4,5,6-Tetrahydro-4,6-dioxopyrimidin-2-yl)cyanamide in the Sprague-Dawley strain rat according to guideline OECD 401 of 1981 and Method B1 of Commission Directive 84/449/EEC. Following a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a suspension in distilled water B.P. at a dose level of 2000 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed for gross pathological examination. There were no deaths, no signs of systemic toxicity nor any abnormalities noted at necropsy. The acute oral median lethal dose (LD50) of (1,4,5,6-Tetrahydro-4,6-dioxopyrimidin-2-yl)cyanamide in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c41b47c-2d0b-4ddd-97ab-4a0a6615f555/documents/88bbbaac-c7ee-4c28-9511-619a3742379b_43d27076-c651-4d88-8da0-490c11a4befe.html,,,,,, "(10aS)-methyl 10a-methoxy-7-methyl-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinoline-9-carboxylate",23495-64-9, Oral: The oral LD50 value of the test item in Wistar rat was established to exceed 2000 mg/kg bw. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3608dfc4-255b-4aa5-98d5-2eb34cc50697/documents/440fb1f1-ae50-4b0f-923c-2e1a78661345_fb83d690-7401-491f-90c2-400b60340d47.html,,,,,, "(10aS)-methyl 10a-methoxy-7-methyl-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinoline-9-carboxylate",23495-64-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3608dfc4-255b-4aa5-98d5-2eb34cc50697/documents/440fb1f1-ae50-4b0f-923c-2e1a78661345_fb83d690-7401-491f-90c2-400b60340d47.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, (10E)-oxacycloheptadec-10-en-2-one,63286-42-0," Acute Oral Toxicity (weight of evidence): LD50 > 5000 mg/kg bw, 2018 1. Acute Oral (Read-Across: oxacycloheptadec-7-en-2-one): LD50 > 5000 mg/kg bw, eq. or similar to OECD TG 401, 1974 2. Expert judgement: assessment of the toxicokinetics of the target substance indicates that the substance has a very low order of acute oral toxicity due to rapid metabolism and excretion. The substance would not expect to meet the classification criteria according to GHS/EU Criteria. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f173b181-bd19-4a08-99d3-969f804a9dda/documents/099de979-6bc2-435b-8086-0a0bc95f4a67_b70a0abb-baed-4625-8f4d-3c7ccd87b209.html,,,,,, (10E)-oxacycloheptadec-10-en-2-one,63286-42-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f173b181-bd19-4a08-99d3-969f804a9dda/documents/099de979-6bc2-435b-8086-0a0bc95f4a67_b70a0abb-baed-4625-8f4d-3c7ccd87b209.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, (17α)-17-hydroxy-3-oxoandrost-4-ene-17-carbonitrile,77881-13-1,"Orientating Oral (Rat, comparable to OECD TG 401): LD50 > 5 g/kg[Schering AG, Report No. 4954, 1984-01-24] ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f840262a-7f88-404c-af8b-f229856943bd/documents/IUC5-0c877031-204e-4595-a511-d3486e0e4052_44d696d4-67c3-4bf7-8127-8fc0ef9d72f9.html,,,,,, (1-ethoxyethoxy)cyclododecane,389083-83-4," Oral: NOAEL (rat): 2250 ppm (equivalent to a mean achieved dose of 216 mg/kg body weight per day) ; male/female, OECD TG 407, 2002 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1fed4d63-37be-43d5-8580-9b470a5d0989/documents/bc9de127-3bff-4ffb-ac65-696226f1c2ff_2bbbe205-68dc-432e-a206-8ae41247214c.html,,,,,, (1-ethoxyethoxy)cyclododecane,389083-83-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1fed4d63-37be-43d5-8580-9b470a5d0989/documents/bc9de127-3bff-4ffb-ac65-696226f1c2ff_2bbbe205-68dc-432e-a206-8ae41247214c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,216 mg/kg bw/day,,rat (1-ethoxyethoxy)cyclododecane,389083-83-4," Oral: measured LD50 > 2000 and < 5000 mg/kg bw and the estimated LD50 cut-off was considered to be 2500 mg/kg bw, female rat, OECD TG 423, 2000 Inhalation: No data Dermal: measured LD50 > 2000 mg/kg bw and the estimated LD50 cut-off value was considered to be > 5000 mg/kg bw, male/female rat, OECD TG 402, 2001 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fed4d63-37be-43d5-8580-9b470a5d0989/documents/c1e2b8f8-9bfb-4274-8a7d-0e87a4de5f2b_2bbbe205-68dc-432e-a206-8ae41247214c.html,,,,,, (1-ethoxyethoxy)cyclododecane,389083-83-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fed4d63-37be-43d5-8580-9b470a5d0989/documents/c1e2b8f8-9bfb-4274-8a7d-0e87a4de5f2b_2bbbe205-68dc-432e-a206-8ae41247214c.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, (1-ethoxyethoxy)cyclododecane,389083-83-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fed4d63-37be-43d5-8580-9b470a5d0989/documents/c1e2b8f8-9bfb-4274-8a7d-0e87a4de5f2b_2bbbe205-68dc-432e-a206-8ae41247214c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "(1-hydroxyethane-1,1-diyl)bis(phosphonic acid), compound with 2-aminoethanol (1:?)",42220-47-3," Under the conditions of a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, the oral administration by gavage of the test item to Wistar rats revealed adverse findings in parental animals and progeny at 600 and 2000/1000 mg/kg bw/d. Thus, the no observed adverse effect level (NOAEL) for general systemic toxicity was 200 mg/kg bw/d in both sexes of parental animals. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de6f5faa-d42a-4d97-8316-9a4d5c794b2e/documents/604265ed-2989-43e7-b061-2a072eb2eb33_5aaee848-1777-42c8-b70a-7a7dd10ec962.html,,,,,, "(1-hydroxyethane-1,1-diyl)bis(phosphonic acid), compound with 2-aminoethanol (1:?)",42220-47-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de6f5faa-d42a-4d97-8316-9a4d5c794b2e/documents/604265ed-2989-43e7-b061-2a072eb2eb33_5aaee848-1777-42c8-b70a-7a7dd10ec962.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "(1-hydroxyethane-1,1-diyl)bis(phosphonic acid), compound with 2-aminoethanol (1:?)",42220-47-3," According to an OECD 423 and GLP compliant study the median lethal dose of the test item waterfree after oral administration was found to be greater than 2000 mg/kg bw in rats. According to an OECD 402 and GLP compliant study the median lethal dose (LD50) of the test item, waterfree after dermal application was found to be greater than 2000 mg/kg bw in male and female rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de6f5faa-d42a-4d97-8316-9a4d5c794b2e/documents/dc876dc0-1258-4cf7-a595-baf368d2a522_5aaee848-1777-42c8-b70a-7a7dd10ec962.html,,,,,, "(1-hydroxyethane-1,1-diyl)bis(phosphonic acid), compound with 2-aminoethanol (1:?)",42220-47-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de6f5faa-d42a-4d97-8316-9a4d5c794b2e/documents/dc876dc0-1258-4cf7-a595-baf368d2a522_5aaee848-1777-42c8-b70a-7a7dd10ec962.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "(1-hydroxyethane-1,1-diyl)bis(phosphonic acid), compound with 2-aminoethanol (1:?)",42220-47-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de6f5faa-d42a-4d97-8316-9a4d5c794b2e/documents/dc876dc0-1258-4cf7-a595-baf368d2a522_5aaee848-1777-42c8-b70a-7a7dd10ec962.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "(1-hydroxyethylidene)bisphosphonic acid, potassium salt",67953-76-8," There are no repeated dose toxicity data for HEDP-xK, therefore good quality data are read-across from the category member HEDP (2-3Na). In a well conducted, repeated oral dose toxicity study (reliability score 2), conducted using a protocol according to OECD 408 (Repeated Dose 90-Day Oral Toxicity in Rodents) and pre-GLP, the NOAEL for HEDP (2-3Na) was concluded to be 41 mg/kg bw/day (equivalent to 34 mg active acid/kg bw/day) based on anaemia at high doses (Huntingdon, 1977). No repeated dose inhalation or dermal studies are available. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/287f6d34-13a5-4f16-931a-b82015e39422/documents/4bffa3b9-de95-4670-bf77-396ba9d28780_dbc8d3ec-b9c8-47dd-9ac0-18ca5c47ed88.html,,,,,, "(1-hydroxyethylidene)bisphosphonic acid, potassium salt",67953-76-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/287f6d34-13a5-4f16-931a-b82015e39422/documents/4bffa3b9-de95-4670-bf77-396ba9d28780_dbc8d3ec-b9c8-47dd-9ac0-18ca5c47ed88.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,34 mg/kg bw/day,,rat "(1-hydroxyethylidene)bisphosphonic acid, potassium salt",67953-76-8," There are no acute toxicity data for HEDP-xK, therefore good quality data are read-across from the category members HEDP-4Na and HEDP (2-3Na). In an acute oral study conducted using a protocol similar to the now deleted OECD Test Guideline 401 but pre-GLP, undiluted HEDP-4Na was administered to five Sprague-Dawley rats by oral gavage at doses of 2000, 2500, 3200 or 4000 mg/kg bw (aqueous solution). The LD50 was calculated to be 2850 mg/kg bw (equivalent to 940 mg/kg/day bw active salt and 659 mg/kg bw/day active acid) (BioDynamics Inc., 1985; reliability 2). In a well-conducted acute dermal toxicity limit test conducted according to a protocol similar to OECD Test Guideline 402 and pre-GLP, 5000 mg/kg bw of HEDP-4Na was applied to the skin of New Zealand white rabbits (5 per sex) under an occlusive dressing for 24 hours. The LD50 was determined to be >5000 mg/kg bw (equivalent to 3505 mg active acid/kg bw) (BioDynamics Inc., 1985; reliability 2).     In an acute dermal toxicity study (reliability score 2), conducted prior to the adoption of OECD test guidelines and pre-GLP, the LD50 for HEDP (2-3Na) was >7940 mg/kg bw in rabbits. This was based on no observed mortality although some toxicity was observed including reduced appetite and activity for one to three days (Younger lab, 1971). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/287f6d34-13a5-4f16-931a-b82015e39422/documents/a870b0b6-ace0-4cd1-a6d9-8b50ba8b8f76_dbc8d3ec-b9c8-47dd-9ac0-18ca5c47ed88.html,,,,,, "(1-hydroxyethylidene)bisphosphonic acid, potassium salt",67953-76-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/287f6d34-13a5-4f16-931a-b82015e39422/documents/a870b0b6-ace0-4cd1-a6d9-8b50ba8b8f76_dbc8d3ec-b9c8-47dd-9ac0-18ca5c47ed88.html,,oral,LD50,940 mg/kg bw,no adverse effect observed, "(1-hydroxyethylidene)bisphosphonic acid, potassium salt",67953-76-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/287f6d34-13a5-4f16-931a-b82015e39422/documents/a870b0b6-ace0-4cd1-a6d9-8b50ba8b8f76_dbc8d3ec-b9c8-47dd-9ac0-18ca5c47ed88.html,,dermal,LD50,"> 3,505 mg/kg bw",no adverse effect observed, "(1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate",5945-33-5,"Oral:  NOAEL of 1000 mg/kg/day (highest dose tested) in rats to be clearly established.(EEC Directive 92/69/EEC, Method B7) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d799161-547a-4c1a-8e62-3dfffc352814/documents/IUC5-2630ab4b-650f-46e4-9af0-6e4405ddad97_97d6f7fe-ca0b-4bf6-938b-9bf487ff575f.html,,,,,, "(1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate",5945-33-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d799161-547a-4c1a-8e62-3dfffc352814/documents/IUC5-2630ab4b-650f-46e4-9af0-6e4405ddad97_97d6f7fe-ca0b-4bf6-938b-9bf487ff575f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, "(1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate",5945-33-5,Oral:LD50: >2 000 mg/kg for rat (limit test) (OECD TG401)Dermal:LD50: >2 000 mg/kg for rat (limit test) (OECD TG402) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d799161-547a-4c1a-8e62-3dfffc352814/documents/IUC5-e876d68f-6888-4f78-be48-0e2ce61fd880_97d6f7fe-ca0b-4bf6-938b-9bf487ff575f.html,,,,,, "(1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate",5945-33-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d799161-547a-4c1a-8e62-3dfffc352814/documents/IUC5-e876d68f-6888-4f78-be48-0e2ce61fd880_97d6f7fe-ca0b-4bf6-938b-9bf487ff575f.html,,oral,LD50,"2,000 mg/kg bw",, "(1-methylethylidene)di-4,1-phenylenetetraphenyl diphosphate",5945-33-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d799161-547a-4c1a-8e62-3dfffc352814/documents/IUC5-e876d68f-6888-4f78-be48-0e2ce61fd880_97d6f7fe-ca0b-4bf6-938b-9bf487ff575f.html,,dermal,LD50,"2,000 mg/kg bw",, (1-methylpropylidene)bis[tert-butyl] peroxide,13653-62-8," No study is available to assess the repeated dose toxicity of (1-methylpropylidene)bis[tert-butyl] peroxide, therefore, it is evaluated through a read across to 2,2-di(tert-butylperoxy) butane (CAS # 2167-23-9). A study was designed to investigate the systemic toxicity and potential adverse effects of Trigonox D-C50 (50.4% 2,2-di(tert-butylperoxy) butane (CAS # 2167-23-9) in isododecane) on reproduction (including offspring development) and is designed to be compatible with the requirements of the OECD Guidelines for Testing of Chemicals No. 422 “Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test” (adopted 22 March 1996). Trigonox D-C50 was administered by gavage to three groups, each of twelve male and twelve female Wistar Han™:RccHan™:WIST strain rats, for up to seven weeks (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dose levels of 50, 150 and 500 mg/kg bw/day. A control group of twelve males and twelve females was dosed with vehicle alone (Arachis oil BP). Clinical signs, behavioral assessments, body weight change and food and water consumption were monitored during the study. Extensive functional observations were performed on five selected males from each dose group after the completion of the pairing phase, and for five selected parental females from each dose group on Day 4 post partum. Hematology and blood chemistry were evaluated prior to termination on five selected males and females from each dose group. Adult males were terminated on Days 43 or 44, followed by the termination of all females and offspring on Day 5 post partum. Any female which did not produce a pregnancy was terminated on or after Day 25 post coitum. All animals were subjected to a gross necropsy examination and histopathological evaluation of selected tissues was performed. There were no unscheduled deaths during the study. Animals of either sex treated with 500 mg/kg bw/day showed increased salivation from Day 4 onwards. Animals of either sex treated with 150 mg/kg bw/day also showed increased salivation albeit to a lesser extent. Two males treated with 500 mg/kg bw/day had pilo- erection between Days 20 and 31. No such effects were detected in animals of either sex treated with 50 mg/kg bw/day. One male treated with 500 mg/kg bw/day had pilo-erection during the final week of assessments. Another male showed increased salivation during Week 2 assessments. No such effects were evident in females treated with 500 mg/kg bw/day or in animals of either sex treated with 150 or 50 mg/kg bw/day. There was no effect of treatment with the test item at any dose level on functional performance in animals of either sex. Sensory reactivity scores across all test item-treated dose groups were similar to controls. Males treated with 500 mg/kg bw/day showed a reduction in body weight gain during the first two weeks of treatment. Overall body weight gain for these males was also reduced.  A slight reduction in body weight gain was evident in females treated with 500 mg/kg bw/day during the first week of treatment, however, recovery was evident thereafter. No adverse effects were evident in animals of either sex treated with 150 or 50 mg/kg bw/day. Males treated with 500 mg/kg bw/day showed a slight reduction in food consumption during the first two weeks of treatment. Recovery was evident thereafter. No adverse effects were evident in males treated with 150 or 50 mg/kg bw/day or in treated females during maturation, gestation or lactation. Food conversion efficiency was slightly reduced in animals of either sex treated with 500 mg/kg bw/day during the first week of treatment, however, recovery was evident thereafter. Males treated with 500 mg/kg bw/day showed an increase in overall water consumption during the pre-pairing phase. No such effects were evident in females treated with 500 mg/kg bw/day or in animals of either sex treated with 150 or 50 mg/kg bw/day. There were no toxicologically significant effects detected in the hematological parameters examined. Animals of either sex treated with 500 mg/kg bw/day showed an increase in alanine aminotransferase. Males from this treatment group also showed an increase in aspartate aminotransferase. Females treated with 500 mg/kg bw/day also showed increases in glucose, total protein, albumin and cholesterol. The effect on total protein and cholesterol also extended to females treated with 150 mg/kg bw/day. No toxicologically significant effects were detected in males treated with 150 mg/kg bw/day or in animals of either sex treated with 50 mg/kg bw/day.Eleven males treated with 500 mg/kg bw/day had mottled kidneys. Eight of these males also had enlarged kidneys, one male also had increased pelvic space in the left kidney and the left kidney was fluid filled, one male had an enlarged and dark liver and another male had enlarged kidneys. Five males treated with 150 mg/kg bw/day had mottled kidneys and one of these males also had increased pelvic space in both kidneys. One male treated with 50 mg/kg bw/day also had mottled kidneys. No such effects were detected in treated females. Males from all treatment groups and females treated with 500 and 150 mg/kg bw/day showed an increase in liver weight both absolute and relative to terminal body weight. Males treated with 500 and 150 mg/kg bw/day also showed an increase in absolute and relative kidney weights. No such effects were evident in females treated with 50 mg/kg bw/day. The following treatment-related microscopic abnormalities were detected: Kidneys: An increase in hyaline droplets (mild or moderate) was evident in all males treated with 500 and 150 mg/kg bw/day and in one male treated with 50 mg/kg bw/day (mild).Basophilic tubules were present in eleven males treated with 500 mg/kg bw/day and ten males treated with 150 mg/kg bw/day. In the remaining male treated with 500 mg/kg bw/day moderate nephropathy was apparent (tubular basophilia along with dilation and interstitial changes). Proteinaceous casts were also present (minimal to moderate) in all males treated with 500 mg/kg bw/day and in two males treated with 150 mg/kg bw/day. Liver:Periportal pigment was present in the bile ducts of three males and two females treated with 500 mg/kg bw/day and in four males treated with 150 mg/kg bw/day. Periportal Kupffer cell pigmentation was present in four males and one female treated with 500 mg/kg bw/day and in one male treated with 150 mg/kg bw/day. Special staining carried out on one control and one male treated with 500 mg/kg bw/day was negative for bile pigment, lipofuscin and hemosiderin. Inflammatory cell infiltration in the periportal area was present in two males and one female treated with 500 mg/kg bw/day. Centrilobular hypertrophy, minimal or mild, was present in four males and four females treated with 500 mg/kg bw/day and in two males and one female treated with 150 mg/kg bw/day. No treatment related changes were evident in animals of either sex treated with 50 mg/kg bw/day. Thyroid Gland: Minimal follicular cell hypertrophy was present in three males and two females treated with 500 mg/kg bw/day and in three males treated with 150 mg/kg bw/day. No treatment related changes were evident in animals of either sex treated with 50 mg/kg bw/day. Centrilobular hypertrophy is generally considered to be due to an adaptive response to mixed function oxidase. This change results in the increased clearance of thyroid hormones and the subsequent compensatory increased production causes hypertrophy of the follicular cells (Capen C.C et al; 2002, Cattley R.C et al; 2002 and Zabka T.S et al; 2011). The oral administration of Trigonox D-C50 (50.4% 2,2-di(tert-butylperoxy) butane (CAS # 2167-23-9) in isododecane) to Wistar Han™:RccHan™:WIST strain rats for a period of up to seven weeks (including two weeks pre-pairing, gestation and early lactation for females) at dose levels 50, 150 and 500 mg/kg bw/day resulted in treatment related effects in animals of either sex treated with 500 and 150 mg/kg bw/day. These included reduced initial body weight gains in either sex at 500 mg/kg bw/day, reduced food consumption and increased water consumption in males at 500 mg/kg bw/day, organ weight changes in either sex at 500 and 150 mg/kg bw/day, macroscopic changes in males at 500 and 150 mg/kg bw/day and microscopic changes in either sex at 500 and 150 mg/kg bw/day. A No Observed Effect Level (NOEL) for systemic toxicity was considered to be 50 mg/kg bw/day for either sex. The inflammatory cell infiltration in the periportal area of the liver in either sex at 500 mg/kg bw/day was considered to represent an adverse effect of treatment. The microscopic liver changes evident in females treated with 150 mg/kg bw/day were considered to be an adaptive response to mixed function oxidase induction (Capen C.C et al; 2002, Cattley R.C et al; 2002 and Zabka T.S et al; 2011). Therefore, a No Observed Adverse Effect Level (NOAEL) can be established at 150 mg/kg bw/day for females. Although the kidney findings of tubular basophilia and proteinaceous casts in male kidneys could be considered an adverse effect, these findings were considered to be associated with alpha 2u-globulin and formation of hyaline droplets, an effect recognized as being both species and sex specific and not relevant for humans. In terms of risk assessment, these findings observed on this study would suggest that a No Observed Adverse Effect Level (NOAEL) can be established at 150 mg/kg bw/day for males because the findings do not reflect true systemic toxicity. Therefore the NOAEL for the repeated dose toxicity was considered to be 150 mg/kg bw/day for Trigonox D-C50 which is equivalent to 75 mg/kg bw/day for pure 2,2-di(tert-butylperoxy) butane. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fcec9e9-46b1-4747-aaaa-fe43aa67786b/documents/829bf6fe-9cea-49a5-9486-2bdb26362c34_90f80e01-e171-49c1-bd0f-b74a5653ece5.html,,,,,, (1-methylpropylidene)bis[tert-butyl] peroxide,13653-62-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fcec9e9-46b1-4747-aaaa-fe43aa67786b/documents/829bf6fe-9cea-49a5-9486-2bdb26362c34_90f80e01-e171-49c1-bd0f-b74a5653ece5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat (1-methylpropylidene)bis[tert-butyl] peroxide,13653-62-8," The single-dose oral toxicity of LUPEROX® 520M50 (49.3% of 2,2-di-(tert-amylperoxy)butane in isododecane) was performed according to the acute toxic class method (OECD 423) in Crl:WI rats. Three female Crl:WI rats were treated with LUPEROX® 520M50 at a dose level of 5000 mg/kg bw. A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 3 hours after the treatment. The test item was administered formulated in corn oil at a concentration of 500 mg/mL at a dose volume of 10 mL/kg bw.  Initially, one female was treated at a dose level of 5000 mg/kg bw. As no mortality was observed, a confirmatory group of two females was treated at the same dose level. No mortality was observed in the confirmatory group; therefore no further testing was required according to OECD 423. Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was measured on Days -1, 0 and 7 and 14 (before necropsy). All animals were subjected to a necropsy and a macroscopic examination.  LUPEROX® 520M50 did not cause mortality at a dose level of 5000 mg/kg bw. There were no systemic clinical signs noted in any animal throughout the study. Body weight gains of LUPEROX® 520M50 treated animals during the study showed no indication of a test item-related effect. There was no evidence of the macroscopic observations at a dose level of 5000 mg/kg bw.  Under the conditions of this study, the acute oral LD0 values of LUPEROX® 520M50 and 2,2-di-(tert-amylperoxy)butane were found to be higher than 5000 and 2465 mg/kg bw in female Crl:WI rats, respectively. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fcec9e9-46b1-4747-aaaa-fe43aa67786b/documents/b77f1a97-ccb6-4cb6-bc24-fc9acbd8b092_90f80e01-e171-49c1-bd0f-b74a5653ece5.html,,,,,, (1-methylpropylidene)bis[tert-butyl] peroxide,13653-62-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fcec9e9-46b1-4747-aaaa-fe43aa67786b/documents/b77f1a97-ccb6-4cb6-bc24-fc9acbd8b092_90f80e01-e171-49c1-bd0f-b74a5653ece5.html,,oral,discriminating dose,"2,465 mg/kg bw",no adverse effect observed, (1R)-2-{[2-(4-aminophenyl)ethyl]amino}-1-phenylethanol hydrochloride,521284-22-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A reliable OECD 422 study conducted to GLP and OECD guidance is available. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/119bcb94-f04e-4b68-ba10-15a9690a3eee/documents/IUC5-aaf81094-b4d6-41bf-9d10-d2d22f6d7142_a916f259-42c6-4e6c-8a0c-1a3391918a9c.html,,,,,, (1R)-2-{[2-(4-aminophenyl)ethyl]amino}-1-phenylethanol hydrochloride,521284-22-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/119bcb94-f04e-4b68-ba10-15a9690a3eee/documents/IUC5-aaf81094-b4d6-41bf-9d10-d2d22f6d7142_a916f259-42c6-4e6c-8a0c-1a3391918a9c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,12.5 mg/kg bw/day,,rat (1R)-2-{[2-(4-aminophenyl)ethyl]amino}-1-phenylethanol hydrochloride,521284-22-0,An acute oral toxicity study (toxic class method) and an acute inhalation study were conducted. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/119bcb94-f04e-4b68-ba10-15a9690a3eee/documents/IUC5-2ce3dd8f-2aa7-4920-9cb6-272eb9ec7d11_a916f259-42c6-4e6c-8a0c-1a3391918a9c.html,,,,,, (1R)-2-{[2-(4-aminophenyl)ethyl]amino}-1-phenylethanol hydrochloride,521284-22-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/119bcb94-f04e-4b68-ba10-15a9690a3eee/documents/IUC5-2ce3dd8f-2aa7-4920-9cb6-272eb9ec7d11_a916f259-42c6-4e6c-8a0c-1a3391918a9c.html,,oral,LD50,200 mg/kg bw,adverse effect observed, (1R)-2-{[2-(4-aminophenyl)ethyl]amino}-1-phenylethanol hydrochloride,521284-22-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/119bcb94-f04e-4b68-ba10-15a9690a3eee/documents/IUC5-2ce3dd8f-2aa7-4920-9cb6-272eb9ec7d11_a916f259-42c6-4e6c-8a0c-1a3391918a9c.html,,inhalation,LC50,"1,000 mg/m3",adverse effect observed, "(1R)-6,6-dimethylbicyclo[3.1.1]hept-2-en-2-ethanol",35836-73-8," Acute toxicity, oral in rats: LD50 = 890 mg/kg bw (equivalent or similar to OECD 401, non-GLP, K, Rel. 2) Acute toxicity, dermal in rabbits: LD50 > 5000 mg/kg bw (equivalent or similar to OECD 402, non-GLP, K, Rel.2) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b6680f5-7bfe-4aa1-b26d-4ff7ddbfc3ab/documents/bc4e1ea5-8ecc-47cf-971b-eb3cbb9f3596_652ae68e-e500-4883-b212-a34ed112673b.html,,,,,, "(1R)-6,6-dimethylbicyclo[3.1.1]hept-2-en-2-ethanol",35836-73-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b6680f5-7bfe-4aa1-b26d-4ff7ddbfc3ab/documents/bc4e1ea5-8ecc-47cf-971b-eb3cbb9f3596_652ae68e-e500-4883-b212-a34ed112673b.html,,oral,LD50,890 mg/kg bw,adverse effect observed, "(1R)-6,6-dimethylbicyclo[3.1.1]hept-2-en-2-ethanol",35836-73-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b6680f5-7bfe-4aa1-b26d-4ff7ddbfc3ab/documents/bc4e1ea5-8ecc-47cf-971b-eb3cbb9f3596_652ae68e-e500-4883-b212-a34ed112673b.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "(1R,2R)-1,2-Cyclohexanedimethanol",65376-05-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e04a94af-db15-4828-9024-0b56631c2fb2/documents/8bdf55e8-6888-4799-9c46-f3c2e714f348_4e5b77dc-4d5a-4040-b72b-0b15eeb1b8ec.html,,oral,LD50,800 mg/kg bw,, "Reaction Mass of (2R)-2-methyl-4-[(1R)-2,2,3-trimethylcyclopent-3-en-1-yl]pent-4-enal and (2S)-2-methyl-4-[(1R)-2,2,3-trimethylcyclopent-3-en-1-yl]pent-4-enal",166432-53-7," Oral: NOEL (rat): 225 ppm (equivalent to a mean achieved dose of 23 mg/kg body weight per day) ; male/female, OECD TG 407, 2002 Applicant assessment indicates: Oral: NOAEL (rat): 15000 ppm (equivalent to a mean achieved dose of 1212 mg/kg body weight per day) ; male/female, OECD TG 407, 2002 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12e593e5-2c6b-47f0-b7af-bbe6b6673e1c/documents/5e5c3722-b7c5-4fad-937c-3a9981a9f2d3_1a80de5a-4543-4b1e-b06e-45f917615052.html,,,,,, "Reaction Mass of (2R)-2-methyl-4-[(1R)-2,2,3-trimethylcyclopent-3-en-1-yl]pent-4-enal and (2S)-2-methyl-4-[(1R)-2,2,3-trimethylcyclopent-3-en-1-yl]pent-4-enal",166432-53-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12e593e5-2c6b-47f0-b7af-bbe6b6673e1c/documents/5e5c3722-b7c5-4fad-937c-3a9981a9f2d3_1a80de5a-4543-4b1e-b06e-45f917615052.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,212 mg/kg bw/day",,rat "Reaction Mass of (2R)-2-methyl-4-[(1R)-2,2,3-trimethylcyclopent-3-en-1-yl]pent-4-enal and (2S)-2-methyl-4-[(1R)-2,2,3-trimethylcyclopent-3-en-1-yl]pent-4-enal",166432-53-7," Oral: measured LD50 > 2000 mg/kg bw and the estimated LD50 cut-off is considered to be > 5000 mg/kg bw, male/female rat, OECD TG 420, 1995 Inhalation: No data Dermal: measured LD50 > 2000 mg/kg bw and the estimated LD50 cut-off value was considered to be > 5000 mg/kg bw, male/female rat, OECD TG 402, 2001 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12e593e5-2c6b-47f0-b7af-bbe6b6673e1c/documents/625df00c-afd0-4874-b78a-b3fec1cd2266_1a80de5a-4543-4b1e-b06e-45f917615052.html,,,,,, "Reaction Mass of (2R)-2-methyl-4-[(1R)-2,2,3-trimethylcyclopent-3-en-1-yl]pent-4-enal and (2S)-2-methyl-4-[(1R)-2,2,3-trimethylcyclopent-3-en-1-yl]pent-4-enal",166432-53-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12e593e5-2c6b-47f0-b7af-bbe6b6673e1c/documents/625df00c-afd0-4874-b78a-b3fec1cd2266_1a80de5a-4543-4b1e-b06e-45f917615052.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Reaction Mass of (2R)-2-methyl-4-[(1R)-2,2,3-trimethylcyclopent-3-en-1-yl]pent-4-enal and (2S)-2-methyl-4-[(1R)-2,2,3-trimethylcyclopent-3-en-1-yl]pent-4-enal",166432-53-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12e593e5-2c6b-47f0-b7af-bbe6b6673e1c/documents/625df00c-afd0-4874-b78a-b3fec1cd2266_1a80de5a-4543-4b1e-b06e-45f917615052.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "(1R,2R,4S)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol",2217-02-9," Key study: Read-across approach. Test method similar to OECD 408. No data on GLP. Based on the read-across approach, the NOEL for the test item after an oral exposure of 13 weeks was determined to be 11.79 mg/kg bw/day in rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc62245c-ef9a-4104-9e11-2dfa7eb2c838/documents/8508fe38-3572-4493-87d9-efd2796d637c_10a28750-43a6-4fbd-8463-45357527eb94.html,,,,,, "(1R,2R,4S)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol",2217-02-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc62245c-ef9a-4104-9e11-2dfa7eb2c838/documents/8508fe38-3572-4493-87d9-efd2796d637c_10a28750-43a6-4fbd-8463-45357527eb94.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,11.79 mg/kg bw/day,,rat "(1R,2R,4S)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol",2217-02-9," Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue L-borneol, the acute oral LD50 value of d-alpha fenchol is 6500 mg/kg bw in rats. Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol is >7859 mg/kg bw in rats. Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue isobornyl acetate, the acute oral LD50 value of d-alpha fenchol is 7072 mg/kg bw in mice. Acute oral toxicity: Weight of evidence: Based on the read-across approach from the analogue fenchol, the acute oral LD50 value of d-alpha fenchol is 2050 mg/kg bw in rats. Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue L-Borneol, the acute dermal LD50 value of the test item was determined to be greater than 2000 mg/kg bw in rabbits. Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue isobornyl acetate, the acute dermal LD50 value of the test item was determined to be greater than 15717 mg/kg bw in rabbits. Acute dermal toxicity: Weight of evidence. Based on the read-across approach from the analogue fenchol, The acute dermal LD50 value of the test item was >2000 mg/kg bw in guinea pigs. Acute inhalation toxicity: Data waiving (study scientifically not necessary): According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route needs to be provided. The information is provided for dermal route. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc62245c-ef9a-4104-9e11-2dfa7eb2c838/documents/0a00f6ff-776e-4a1a-8768-9a4371bbf6a0_10a28750-43a6-4fbd-8463-45357527eb94.html,,,,,, "(1R,2R,4S)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol",2217-02-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc62245c-ef9a-4104-9e11-2dfa7eb2c838/documents/0a00f6ff-776e-4a1a-8768-9a4371bbf6a0_10a28750-43a6-4fbd-8463-45357527eb94.html,,oral,LD50,"2,050 mg/kg bw",adverse effect observed, "(1R,2R,4S)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-ol",2217-02-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc62245c-ef9a-4104-9e11-2dfa7eb2c838/documents/0a00f6ff-776e-4a1a-8768-9a4371bbf6a0_10a28750-43a6-4fbd-8463-45357527eb94.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "(1R,2S,5R)-2-isopropyl-N-(4-methoxyphenyl)-5-methylcyclohexanecarboxamide",68489-09-8,Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 420; GLP; female rats) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b90579b3-02b4-4666-acf7-b78b6f8a5cd1/documents/IUC5-3e0b98ca-5f40-4fc3-a974-ff5a79adcef5_3f024068-2c0a-4fb2-8579-cd1fcf87d3ea.html,,,,,, "(1R,2S,5R)-2-isopropyl-N-(4-methoxyphenyl)-5-methylcyclohexanecarboxamide",68489-09-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b90579b3-02b4-4666-acf7-b78b6f8a5cd1/documents/IUC5-3e0b98ca-5f40-4fc3-a974-ff5a79adcef5_3f024068-2c0a-4fb2-8579-cd1fcf87d3ea.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "(1RS,4Z,8E,12RS)-13-oxabicyclo[10.1.0]trideca-4,8-diene",55722-64-0," Repeated dose toxicity : target : (1RS,4Z,8E,12RS)-13-oxabicyclo[10.1.0]trideca-4,8-diene : Oral (dietary): NOAEL (rat): male/female: 3750 ppm (equivalent to ≥ 223 mg/kg bw/day), 2020 Read-Across: source data : 1,5,10-trimethylcyclododeca-1,5,9-triene, epoxidized : Oral (dietary): NOAEL (rat): male/female: 3750 ppm (equivalent to ≥ 223 mg/kg bw/day), OECD TG 422, 2017 The changes in the thyroid glands observed in rodents were consequences of hepatic enzyme induction are of little toxicological relevance to man. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8530d8e9-928c-433d-86ff-08744f5bc33e/documents/edd68ffd-7163-4668-a514-55fd89d7c118_3bf96d54-264c-4573-8773-b9a780295927.html,,,,,, "(1RS,4Z,8E,12RS)-13-oxabicyclo[10.1.0]trideca-4,8-diene",55722-64-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8530d8e9-928c-433d-86ff-08744f5bc33e/documents/edd68ffd-7163-4668-a514-55fd89d7c118_3bf96d54-264c-4573-8773-b9a780295927.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,223 mg/kg bw/day,,rat "(1RS,4Z,8E,12RS)-13-oxabicyclo[10.1.0]trideca-4,8-diene",55722-64-0," Acute Oral Toxicity : target : (1RS,4Z,8E,12RS)-13-oxabicyclo[10.1.0]trideca-4,8-diene : LD50 > 5000 mg/kg bw, 2020 Read-Across: source data : 1,5,10-trimethylcyclododeca-1,5,9-triene, epoxidized : Oral: measured LD50 > 2000 mg/kg bw and applicant assessment indicates LD50 -cut off > 5000 mg/kg bw, female rat, OECD TG 423, 2006 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8530d8e9-928c-433d-86ff-08744f5bc33e/documents/443dc742-2be8-40eb-a544-c60925f21a45_3bf96d54-264c-4573-8773-b9a780295927.html,,,,,, "(1RS,4Z,8E,12RS)-13-oxabicyclo[10.1.0]trideca-4,8-diene",55722-64-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8530d8e9-928c-433d-86ff-08744f5bc33e/documents/443dc742-2be8-40eb-a544-c60925f21a45_3bf96d54-264c-4573-8773-b9a780295927.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, (1S)-2-Chloro-1-methyl-2-oxoethyl acetate,36394-75-9,NOAEL in male and females= 50 mg/kg bw/dayThe NOEL of 50 mg/kg is only valid for females.A NOEL for males was not observed under the conditions of this study. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af080b5e-8c5b-480f-9de9-b8cd54431c91/documents/782e7a9e-c9e5-4b26-a931-da61305f40c0_990afa5a-9670-43e1-b6ce-de93c41c6777.html,,,,,, (1S)-2-Chloro-1-methyl-2-oxoethyl acetate,36394-75-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af080b5e-8c5b-480f-9de9-b8cd54431c91/documents/782e7a9e-c9e5-4b26-a931-da61305f40c0_990afa5a-9670-43e1-b6ce-de93c41c6777.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat (1S)-2-Chloro-1-methyl-2-oxoethyl acetate,36394-75-9,"The oral LD50 of the substance was found to be ≤2000 mg/kg bw, while the dermal LD50 was >2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af080b5e-8c5b-480f-9de9-b8cd54431c91/documents/f7e3eae0-3cf6-428d-a3d9-3f53e86dd644_990afa5a-9670-43e1-b6ce-de93c41c6777.html,,,,,, (1S)-2-Chloro-1-methyl-2-oxoethyl acetate,36394-75-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af080b5e-8c5b-480f-9de9-b8cd54431c91/documents/f7e3eae0-3cf6-428d-a3d9-3f53e86dd644_990afa5a-9670-43e1-b6ce-de93c41c6777.html,,oral,LD100,"1,444 mg/kg bw",adverse effect observed, (1S)-2-Chloro-1-methyl-2-oxoethyl acetate,36394-75-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af080b5e-8c5b-480f-9de9-b8cd54431c91/documents/f7e3eae0-3cf6-428d-a3d9-3f53e86dd644_990afa5a-9670-43e1-b6ce-de93c41c6777.html,,dermal,LD0,"> 2,000 mg/kg bw",no adverse effect observed, "(1S)-3,7,7-trimethylbicyclo[4.1.0]hept-3-ene",498-15-7," In a GLPL study conducted according to OECD Guideline 408 study in rats, the NOAEL was established at 12000 ppm (highest dose tested), equivalent to 744 mg/kg bw/day in males and 752 mg/kg bw/day in females. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad95606a-765d-461a-853d-4e722c6d54af/documents/e0ffc291-455a-4846-b8d0-5f7a1636beb0_4149b945-79cc-4410-9ef9-8889a5594b58.html,,,,,, "(1S)-3,7,7-trimethylbicyclo[4.1.0]hept-3-ene",498-15-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad95606a-765d-461a-853d-4e722c6d54af/documents/e0ffc291-455a-4846-b8d0-5f7a1636beb0_4149b945-79cc-4410-9ef9-8889a5594b58.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,748 mg/kg bw/day,,rat "(1S)-3,7,7-trimethylbicyclo[4.1.0]hept-3-ene",498-15-7,"All available studies show oral LD50 equal to or higher than 3700 mg/kg bw in rats.All available studies show dermal LD50 equal to or higher than 2000 mg/kg bw in rabbits. All available studies show inhalation LC50 between 1.05 and 5.07 mg/L in rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): One acute oral toxicity study was available for each of the substances used in the registration dossier of delta-3-carene, i.e. delta-3-carene, alpha pinene and camphene. They showed LD50 of 4800, 3700 and >5000 mg/kg bw, respectively. Although these studies were old and briefly described, they all show consistent results about all these structure-related substances. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The study is GLP compliant and of high quality (Klimisch score = 1). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): One acute dermal toxicity study was available for each of the substances used in the registration dossier of delta-3-carene, i.e. delta-3-carene, alpha pinene and camphene. They showed LD50 >5000, >5000 and >2500 mg/kg bw, respectively. Although these studies were old and briefly described, they all show consistent results about all these structure-related substances. Morevover, the low dermal toxicity is consistent with and confirmed by the low oral toxicity found with all these substances. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad95606a-765d-461a-853d-4e722c6d54af/documents/ca1ccca8-2668-4e41-90dc-74768328eafc_4149b945-79cc-4410-9ef9-8889a5594b58.html,,,,,, "(1S)-3,7,7-trimethylbicyclo[4.1.0]hept-3-ene",498-15-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad95606a-765d-461a-853d-4e722c6d54af/documents/ca1ccca8-2668-4e41-90dc-74768328eafc_4149b945-79cc-4410-9ef9-8889a5594b58.html,,oral,LD50,"4,800 mg/kg bw",no adverse effect observed, "(1S)-3,7,7-trimethylbicyclo[4.1.0]hept-3-ene",498-15-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad95606a-765d-461a-853d-4e722c6d54af/documents/ca1ccca8-2668-4e41-90dc-74768328eafc_4149b945-79cc-4410-9ef9-8889a5594b58.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, (1R-cis)-Cyhalothric Acid,76023-99-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c75986df-1be4-4438-8c8b-8fa7cf4b1d7b/documents/0f014944-0780-4589-925a-260a15197796_a528bd64-64a6-40d5-80bc-376f117d6817.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, "(1S,7S,8S,8aR)-8-{2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl}-7-methyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl(2S)-2-methylbutanoate",73573-88-3,LD 50 > 2000 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8afa7e1b-bcb3-40e3-a7a2-63c6f3f035c6/documents/IUC5-3484aa8d-b74e-4ea5-98a1-d1dd20f8b876_a5eb7a3b-3021-4f00-beeb-e7d6b4616953.html,,,,,, "(1S,7S,8S,8aR)-8-{2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl}-7-methyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl(2S)-2-methylbutanoate",73573-88-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8afa7e1b-bcb3-40e3-a7a2-63c6f3f035c6/documents/IUC5-3484aa8d-b74e-4ea5-98a1-d1dd20f8b876_a5eb7a3b-3021-4f00-beeb-e7d6b4616953.html,,oral,LD50,"2,000 mg/kg bw",, "(1S-endo)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol",464-45-9," Key study: Read-across approach. Test method similar to OECD 408. No data on GLP. Based on the read-across approach, the NOEL for L-borneol after an oral exposure of 13 weeks was determined to be 11.79 mg/kg bw/day in rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/153bf971-3140-49c1-97d1-c7491a0d8068/documents/469414eb-5de9-4ded-95c6-0b648d3ee982_a19c59d9-9993-4969-8f04-3b628840ca2f.html,,,,,, "(1S-endo)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol",464-45-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/153bf971-3140-49c1-97d1-c7491a0d8068/documents/469414eb-5de9-4ded-95c6-0b648d3ee982_a19c59d9-9993-4969-8f04-3b628840ca2f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,11.79 mg/kg bw/day,,rat "(1S-endo)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol",464-45-9," Acute oral toxicity: Key study: The acute oral LD50 value of the test substance is 6500 mg/kg bw in rats. Acute dermal toxicity: Key study: The acute dermal LD50 value of the test substance was >2000 mg/kg bw in rats. Acute inhalation toxicity: Data waiving (study scientifically not necessary): According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The information is provided for dermal route. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/153bf971-3140-49c1-97d1-c7491a0d8068/documents/e1edffb9-bcc5-43dd-9d80-e3d9471fc2a3_a19c59d9-9993-4969-8f04-3b628840ca2f.html,,,,,, "(1S-endo)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol",464-45-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/153bf971-3140-49c1-97d1-c7491a0d8068/documents/e1edffb9-bcc5-43dd-9d80-e3d9471fc2a3_a19c59d9-9993-4969-8f04-3b628840ca2f.html,,oral,LD50,"6,500 mg/kg bw",no adverse effect observed, "(1S-endo)-1,7,7-trimethylbicyclo[2.2.1]heptan-2-ol",464-45-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/153bf971-3140-49c1-97d1-c7491a0d8068/documents/e1edffb9-bcc5-43dd-9d80-e3d9471fc2a3_a19c59d9-9993-4969-8f04-3b628840ca2f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "(Z)-1-Chloro-2,3,3-trifluoroprop-1-ene",1263679-68-0," There are three repeated-dose toxicity studies for HCFO-1233yd(Z) – two via the inhalation route using substance vapours, and one via the oral route in which the test substance was administered by gavage. In the 28-day oral toxicity study, male animals at the top dose (1000 mg/kg bw/day) exhibited effects in motor activity and forelimb grip strength. In the 90-day inhalation toxicity study, changes in body weights were observed but these were reversible and did not alter the histology of these organs. In the 14-day inhalation toxicity study, drowsiness and ataxic gait were observed in the highest dose (equivalent to 54.76 mg/L). Additional effects on organ weights were also noted. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/27b4fd32-8050-4673-bceb-d3a81c17fa32/documents/c159eede-4394-49e6-98e7-7de72bef7fe7_8589dfee-f3c6-45bd-af48-30b0ba48a79e.html,,,,,, "(1α,2β,4β,6α)-2,2,7-trimethyl-3-oxatricyclo[4.1.1.02,4]octane",32162-27-9," - Oral route: The query structure was predicted as GHS category III in Leadscope using Acute Rat Oral Model v2 model. Estimated LD50 by oral route: 100 mg/kg bw (QSAR prediction, K, Kr.2). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdd6f59a-d873-458d-a0c3-c5b0179d8469/documents/442d1f1c-2c9d-4b33-8ec5-c41711efbbb4_3685a4d2-a292-4ff6-9eb7-5504c983f4b2.html,,,,,, "(1α,2β,4β,6α)-2,2,7-trimethyl-3-oxatricyclo[4.1.1.02,4]octane",32162-27-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdd6f59a-d873-458d-a0c3-c5b0179d8469/documents/442d1f1c-2c9d-4b33-8ec5-c41711efbbb4_3685a4d2-a292-4ff6-9eb7-5504c983f4b2.html,,oral,LD50,100 mg/kg bw,adverse effect observed, "(1-λ1-oxidanyl-2,2,6,6-tetramethylpiperidin-4-yl) benzoate",3225-26-1,"The acute oral LD50 toxicity of 4-Hydroxy-TEMPO was tested in a standard OECD 401 guideline study. Classification: H302, Harmful if swallowed. An LD50 of 1053 mg/kg bw was determined. The acute dermal LD50 toxicity of 4-Hydroxy-TEMPO was tested in a standard OECD 402 guideline study. A limit test with rats at 2000 mg/kg bw dose was performed. A LD50 of >2000 mg/kg was determined. Thus, no classification in regard of dermal toxicity is necessary. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Study according to guideline Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): GLP and guideline conform study ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff3ab3b4-a080-4f36-9cc0-11b50a04c35f/documents/IUC5-a34e0a69-1d2d-4a19-8dd1-e6e24f507be1_c4778013-e5e6-42db-88fa-f4fe3106daad.html,,,,,, "(1-λ1-oxidanyl-2,2,6,6-tetramethylpiperidin-4-yl) benzoate",3225-26-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff3ab3b4-a080-4f36-9cc0-11b50a04c35f/documents/IUC5-a34e0a69-1d2d-4a19-8dd1-e6e24f507be1_c4778013-e5e6-42db-88fa-f4fe3106daad.html,,oral,LD50,"1,053 mg/kg bw",adverse effect observed, "(1-λ1-oxidanyl-2,2,6,6-tetramethylpiperidin-4-yl) benzoate",3225-26-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff3ab3b4-a080-4f36-9cc0-11b50a04c35f/documents/IUC5-a34e0a69-1d2d-4a19-8dd1-e6e24f507be1_c4778013-e5e6-42db-88fa-f4fe3106daad.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "(2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(3-(diethylammonio)propylamino)-1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate",159604-94-1,NOEL (28 days): 1000 mg/kg/day ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac918ada-da56-4167-9bec-d4c9ae4d4a33/documents/8cd59176-f0d6-4a66-8ac5-1fe7f5f52baa_9a7ca0fb-a74a-433e-a165-b37e7a4d30e6.html,,,,,, "(2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(3-(diethylammonio)propylamino)-1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate",159604-94-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac918ada-da56-4167-9bec-d4c9ae4d4a33/documents/8cd59176-f0d6-4a66-8ac5-1fe7f5f52baa_9a7ca0fb-a74a-433e-a165-b37e7a4d30e6.html,Short-term repeated dose toxicity – systemic effects,oral,,"1,000 mg/kg bw/day",,rat "(2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(3-(diethylammonio)propylamino)-1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate",159604-94-1,"LD50 (rat, m/f) > 5000 mg/kg bw (acute toxicity oral) LD50 (rat, m/f) > 2000 mg/kg bw (acute toxicity dermal) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac918ada-da56-4167-9bec-d4c9ae4d4a33/documents/a3524e2e-d10d-440c-881d-df51fef41b35_9a7ca0fb-a74a-433e-a165-b37e7a4d30e6.html,,,,,, "(2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(3-(diethylammonio)propylamino)-1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate",159604-94-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac918ada-da56-4167-9bec-d4c9ae4d4a33/documents/a3524e2e-d10d-440c-881d-df51fef41b35_9a7ca0fb-a74a-433e-a165-b37e7a4d30e6.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "(2,2'-(3,3'-dioxidobiphenyl-4,4'-diyldiazo)bis(6-(4-(3-(diethylamino)propylamino)-6-(3-(diethylammonio)propylamino)-1,3,5-triazin-2-ylamino)-3-sulfonato-1-naphtholato))dicopper(II) acetate lactate",159604-94-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac918ada-da56-4167-9bec-d4c9ae4d4a33/documents/a3524e2e-d10d-440c-881d-df51fef41b35_9a7ca0fb-a74a-433e-a165-b37e7a4d30e6.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)-triyl)triethane-2,1-diyl tris(3-mercaptopropionate)",36196-44-8," NOAEL = 20 mg/kg bw/d (13 wk repeated dose toxicity study, oral, rat, NaTG) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5435f4ca-0dde-4dff-ad2c-6dfa06325e09/documents/3716292a-8988-4fc4-8a42-d627374a2e95_3060168a-16e7-4424-8137-6ee766c9a879.html,,,,,, "(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)-triyl)triethane-2,1-diyl tris(3-mercaptopropionate)",36196-44-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5435f4ca-0dde-4dff-ad2c-6dfa06325e09/documents/3716292a-8988-4fc4-8a42-d627374a2e95_3060168a-16e7-4424-8137-6ee766c9a879.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)-triyl)triethane-2,1-diyl tris(3-mercaptopropionate)",36196-44-8, Sufficient data from QSAR models to classify according to acute oral/dermal endpoints. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5435f4ca-0dde-4dff-ad2c-6dfa06325e09/documents/94c3840d-d69b-44a0-964b-0e32312ab9a3_3060168a-16e7-4424-8137-6ee766c9a879.html,,,,,, "(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)-triyl)triethane-2,1-diyl tris(3-mercaptopropionate)",36196-44-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5435f4ca-0dde-4dff-ad2c-6dfa06325e09/documents/94c3840d-d69b-44a0-964b-0e32312ab9a3_3060168a-16e7-4424-8137-6ee766c9a879.html,,oral,LD50,834 mg/kg bw,adverse effect observed, "(2,4,6-trioxo-1,3,5-triazine-1,3,5(2H,4H,6H)-triyl)triethane-2,1-diyl tris(3-mercaptopropionate)",36196-44-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5435f4ca-0dde-4dff-ad2c-6dfa06325e09/documents/94c3840d-d69b-44a0-964b-0e32312ab9a3_3060168a-16e7-4424-8137-6ee766c9a879.html,,dermal,LD50,"1,969 mg/kg bw",adverse effect observed, (2-cyano-1-methylethyl)dodecylethylsulphonium tetrafluoroborate(1-),72140-65-9," Two acute oral and one acute dermal toxicity studies were conducted on MTDID 15670. The result of the studies were:   The rat oral LD50 is between 300-2,000 mg/kg body weight when tested according to OECD 423 (2001). The rat oral LD50 is greater than 2,000 mg/kg body weight when tested according to OECD 401 (1987). The rat dermal LD50 is greater than 2,000 mg/kg when tested according to OECD 402 (1987). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/befb226a-c44c-4bea-87cc-6d46cc10613a/documents/f2024fb5-c02a-4ec0-94dd-6b95f5163a45_d4e7e6f5-c8b5-411a-9b26-e3d93d15298d.html,,,,,, "(2E)-1,1,1,4,4,4-hexafluoro-2-butene",66711-86-2, Acute oral data waived; ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c66354d1-8582-477a-abd4-53d543f14031/documents/6d6897b8-1856-4c5e-bd22-2e5e1b68c897_71ab5356-8ad0-4da3-90c6-a75742820ba5.html,,,,,, (2E)-2-(4-methylbenzylidene)heptanal,154581-97-2,Acute oral toxicity: OECD TG 423: LD50 > 2500 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b0fa96c-5377-4380-b755-ceb49e0b997c/documents/e81af6ab-80a0-4869-bbf0-8a845bd97e2b_3ea23f30-c218-4bde-af33-c8a7945c6179.html,,,,,, "(2E)-2-ethyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol",106185-75-5,"NOAEL for males and females (OECD guideline 408): 891 mg/kg bw/day and 1109 mg/kg bw/day, respectively. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/205fd638-8337-49d7-8039-9a320fbf871e/documents/811c5c0d-a1b6-42ef-815e-8c693edf0956_f6d5b0ed-7b0e-4978-8d54-f4329c7a90e4.html,,,,,, "(2E)-2-ethyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol",106185-75-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/205fd638-8337-49d7-8039-9a320fbf871e/documents/811c5c0d-a1b6-42ef-815e-8c693edf0956_f6d5b0ed-7b0e-4978-8d54-f4329c7a90e4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,981 mg/kg bw/day,,rat "(2E)-2-ethyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol",106185-75-5,Two oral acute toxicity studies are available showing LD50 > 2000 mg/kg bw.One dermal acute toxicity study is available showing LD50 > 4600 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/205fd638-8337-49d7-8039-9a320fbf871e/documents/3af2ce3c-a28e-46b5-a9c2-5b31e376afc5_f6d5b0ed-7b0e-4978-8d54-f4329c7a90e4.html,,,,,, "(2E)-2-ethyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol",106185-75-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/205fd638-8337-49d7-8039-9a320fbf871e/documents/3af2ce3c-a28e-46b5-a9c2-5b31e376afc5_f6d5b0ed-7b0e-4978-8d54-f4329c7a90e4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(2E)-2-ethyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol",106185-75-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/205fd638-8337-49d7-8039-9a320fbf871e/documents/3af2ce3c-a28e-46b5-a9c2-5b31e376afc5_f6d5b0ed-7b0e-4978-8d54-f4329c7a90e4.html,,dermal,LD50,"4,600 mg/kg bw",no adverse effect observed, (2E)-2-methyl-3-(4-methylphenyl)prop-2-en-1-ol,56138-10-4," Oral: NOAEL (rat): 600 mg/kg bw/day ; male/female, OECD TG 407, 2012 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39f6009e-c179-4b65-a4f8-2ff5c89c525c/documents/0108dd29-538f-425e-bc21-6c02b48c1a97_e962d061-01dd-4ad5-84c6-3b1c169afbfc.html,,,,,, (2E)-2-methyl-3-(4-methylphenyl)prop-2-en-1-ol,56138-10-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39f6009e-c179-4b65-a4f8-2ff5c89c525c/documents/0108dd29-538f-425e-bc21-6c02b48c1a97_e962d061-01dd-4ad5-84c6-3b1c169afbfc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat (2E)-2-methyl-3-(4-methylphenyl)prop-2-en-1-ol,56138-10-4," Oral: measured LD50 > 300 and < 2000 mg/kg bw and the estimated LD50 cut-off was considered to be 2000 mg/kg bw, female rat, OECD TG 423, 2012 Inhalation: LC50 (male/female): > 5.1 mg/L, mean maximum achievable atmosphere concentration, male/female rat, OECD TG 403, 2012 Dermal: measured LD50 > 2000 mg/kg bw and the estimated LD50 cut-off value was considered to be > 5000 mg/kg bw, male/female rat, OECD TG 402, 2012 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39f6009e-c179-4b65-a4f8-2ff5c89c525c/documents/b9c20d40-35ee-45a8-8ed0-08903d6ac47b_e962d061-01dd-4ad5-84c6-3b1c169afbfc.html,,,,,, (2E)-2-methyl-3-(4-methylphenyl)prop-2-en-1-ol,56138-10-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39f6009e-c179-4b65-a4f8-2ff5c89c525c/documents/b9c20d40-35ee-45a8-8ed0-08903d6ac47b_e962d061-01dd-4ad5-84c6-3b1c169afbfc.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, (2E)-2-methyl-3-(4-methylphenyl)prop-2-en-1-ol,56138-10-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39f6009e-c179-4b65-a4f8-2ff5c89c525c/documents/b9c20d40-35ee-45a8-8ed0-08903d6ac47b_e962d061-01dd-4ad5-84c6-3b1c169afbfc.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, (2E)-2-methyl-3-(4-methylphenyl)prop-2-en-1-ol,56138-10-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39f6009e-c179-4b65-a4f8-2ff5c89c525c/documents/b9c20d40-35ee-45a8-8ed0-08903d6ac47b_e962d061-01dd-4ad5-84c6-3b1c169afbfc.html,,inhalation,discriminating conc.,"5,100 mg/m3",no adverse effect observed, (2E)-2-methyl-3-phenylacrylaldehyde,15174-47-7,"Key 90 day oral (OECD 408) NOAEL in rats: 500 mg/kg bw/day   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A key substance specific study available for assessment. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0862a3e-56c7-4a49-82c8-a80183a9f1b1/documents/f61b52d4-743c-4bc2-9a63-46fbfed32621_9a0efa2d-a8e8-46b9-b588-58222cef3e19.html,,,,,, (2E)-2-methyl-3-phenylacrylaldehyde,15174-47-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0862a3e-56c7-4a49-82c8-a80183a9f1b1/documents/f61b52d4-743c-4bc2-9a63-46fbfed32621_9a0efa2d-a8e8-46b9-b588-58222cef3e19.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat (2E)-2-methyl-3-phenylacrylaldehyde,15174-47-7, Acute Oral Toxicity: LD50 = 2050 mg/Kg Acute Dermal Toxicity: LD50 > 5000 mg/Kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0862a3e-56c7-4a49-82c8-a80183a9f1b1/documents/7d8c655d-150f-4b12-b5b7-bf930d52dd4e_9a0efa2d-a8e8-46b9-b588-58222cef3e19.html,,,,,, (2E)-2-methyl-3-phenylacrylaldehyde,15174-47-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0862a3e-56c7-4a49-82c8-a80183a9f1b1/documents/7d8c655d-150f-4b12-b5b7-bf930d52dd4e_9a0efa2d-a8e8-46b9-b588-58222cef3e19.html,,oral,LD50,"2,050 mg/kg bw",adverse effect observed, (2E)-2-methyl-3-phenylacrylaldehyde,15174-47-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0862a3e-56c7-4a49-82c8-a80183a9f1b1/documents/7d8c655d-150f-4b12-b5b7-bf930d52dd4e_9a0efa2d-a8e8-46b9-b588-58222cef3e19.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, (2E)-3-[(tert-butoxycarbonyl)(propan-2-yl)amino]-2-(4-chlorophenyl)prop-2-enoic acid,1489004-27-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): LD50 > 2’000 mg/kg (oral, rat) (OECD No. 420 (Fixed Dose Method)) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b657123a-93e3-471c-8dce-03feb7e67720/documents/f14e396d-1833-460d-9e0f-6e925acbf787_6cfc3d10-e510-4dc8-82bf-2d5ad14cfd6d.html,,,,,, (2E)-3-[(tert-butoxycarbonyl)(propan-2-yl)amino]-2-(4-chlorophenyl)prop-2-enoic acid,1489004-27-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b657123a-93e3-471c-8dce-03feb7e67720/documents/f14e396d-1833-460d-9e0f-6e925acbf787_6cfc3d10-e510-4dc8-82bf-2d5ad14cfd6d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Propenoic acid, (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl ester",69701-99-1,"It is concluded that the oral administration of MEDOL-10 to Han Wistar rats at doses of 30,100 or 300 mg/kg/day for five weeks to males and for two weeks before pairing, throughout gestation and up to Day 13 of lactation in females was well-tolerated in the adult animals but caused histopathological changes to the non-glandular stomach (slight to moderate hyperplasia, minimal erosions and/or slight to moderate ulcerations) in both sexes receiving 100 or 300 mg/kg/day. These changes were considered to be secondary to test article-relatedlocal irritation and not systemic toxicity and therefore, based on the results of this study, it is concluded that the No-Observed-Adverse-Effect-Level (NOAEL) for systemic toxicity is 300 mg/kg/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Study conducted under GLP, reliability 1. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86f541bc-d5d1-4e19-8e87-60495d12a608/documents/ddcfb477-35c5-4a64-a3cb-52c1afdf537f_c5812f60-2eff-4560-af21-bf2cac2c3471.html,,,,,, "2-Propenoic acid, (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl ester",69701-99-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86f541bc-d5d1-4e19-8e87-60495d12a608/documents/ddcfb477-35c5-4a64-a3cb-52c1afdf537f_c5812f60-2eff-4560-af21-bf2cac2c3471.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2-Propenoic acid, (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl ester",69701-99-1,Acute oral toxicity (rats): LC50 >2000 mg/ kg bw Acute inhalation toxicity (rats): LC50 >0.942 mg/L but <5.607 mg/L mg/ kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86f541bc-d5d1-4e19-8e87-60495d12a608/documents/0b66f702-2fce-4329-8650-7de7f9708372_c5812f60-2eff-4560-af21-bf2cac2c3471.html,,,,,, "2-Propenoic acid, (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl ester",69701-99-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86f541bc-d5d1-4e19-8e87-60495d12a608/documents/0b66f702-2fce-4329-8650-7de7f9708372_c5812f60-2eff-4560-af21-bf2cac2c3471.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2-Propenoic acid, (2-ethyl-2-methyl-1,3-dioxolan-4-yl)methyl ester",69701-99-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86f541bc-d5d1-4e19-8e87-60495d12a608/documents/0b66f702-2fce-4329-8650-7de7f9708372_c5812f60-2eff-4560-af21-bf2cac2c3471.html,,inhalation,LC50,> 0.942 mg/L,adverse effect observed, "(2-hydroxy-1,1-dimethylethyl)ammonium toluene-4-sulphonate",68298-05-5,"OECD 422 DOSE RANGE FINDING STUDY (Provivo, 2020) The aim of the study was to select the dose levels of the test item for the main reproduction/developmental toxicity study (OECD 422). The rats were treated with 65, 200 or 600 mg test item/kg b.w. daily from test day 1 to test day 14. On test day 8 the high dose level was increased to 1000 mg test item/kg b.w. daily, as no signs of toxicity were noted. None of the animals died prematurely. No test item-related observations were noted in behaviour, the external appearance or the appearance of the faeces. Body weight and food consumption of the male and female animals revealed no test item-related differences. During the macroscopic inspection at necropsy mandibular lymph nodes with an increased size were noted for nearly all male and female animals of the intermediate and the high dose group (200 or 600/1000 mg test item/kg b.w./day). After consideration of these data, the following dose levels are suggested for a reproduction/ developmental toxicity study in CD® rats based on OECD guideline 422: Group 1:    Control (vehicle) Group 2:    100 mg test item/ kg b.w./day Group 3:    300 mg test item/ kg b.w./day Group 4:    1000 mg test item/ kg b.w./day     OECD 422 MAIN STUDY (Provivo, 2022) The aim of the study was to obtain information on possible effects of the test item on general toxicity, reproduction and/or development based on OECD guideline 422. The test item was administered orally to rats at dose levels of 100, 300 or 1000 mg/kg b.w./day. No pathological lesions in the reproductive organs were related to the test item were noted during the histopathological examination in the dams that delivered live pups, regardless of the dose group (100, 300 or 1000 mg test item/kg b.w./day).Histological differences were noted of the high dose females which lost all implantations. These included implantation sites appearing unphysiological, resorption in the uterus, poorly developed corpora lutea in the ovary and poorly developed mammary glands in 2 of 5 (2/5) females of Group 4. Poorly developed corpora lutea and mammary glands indicate the insufficient progesterone level necessary to maintain pregnancy. There were no abnormalities in the histology of the reproductive organs from the remaining three females of Group 4, as well as from 5 females/group of Groups 2 and 3, examined in this study.Histopathological examination revealed pathological changes of the adrenal glands of the female high dose animals (1000 mg test item/kg b.w./day) in form of diffuse adrenocortical hypertrophy or multifocal to diffuse fatty vacuoles. Additionally, an increased group mean severity grade for thymus atrophy was observed for the female high dose animals. These results may indicate that the HD females, even in females successful of pregnancy, were under the stressful condition, although no major differences in the terminal body weights were detected.  At the high dose level (1000 mg test item/kg b.w./day), a reduced number of implants per dam was noted. Additionally, 6 of 9 pregnant high dose females displayed a resorption of all of their implantations, resulting in an increased post-implantation loss and a decreased birth index. These effects were due to stress of the hig dose females.No influence on the viability index was noted. Following the decreased birth index a reduction of the litter weight was noted for the high dose group (1000 mg test item/kg b.w./day). The implantation loss and the subsequently reduced birth index was also a consequence of the high stress level of the high dosed females.No test item-related abnormalities (malformations or variations) were noted during the external macroscopic examination of the pups at necropsy. The No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be 300 mg/kg/day for female rats because dosage of of 1000 mg/kg/day resulted in toxicologically significant histopathological findings in the uterus such as unphysiological, resorptions, poorly developed corpora lutea in the ovary and poorly developed mammary glands. Histopathological changes in the adrenal glands were noted for the female high dose animals  in form of diffuse adrenocortical hypertrophy or multifocal to diffuse fatty vacuoles. In addition, the group mean severity grade for thymus atrophy was increased in the high dose females. These are stress induced effects. For male rats no toxicological effects could be observed up to the highest tested dose of 1000 mg/kg bw d.  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch 1 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5059266e-65d6-42c0-b7f4-428a38bed9a1/documents/3c3359a8-21a0-4842-999e-3f45039867b8_d5eac7b6-655e-4e17-855d-9a7b1445af48.html,,,,,, "(2-hydroxy-1,1-dimethylethyl)ammonium toluene-4-sulphonate",68298-05-5,"The oral toxicity was determined in an OECD 423 guideline study using Sprague Dawley rats (MB Research, 2016). The oral LD50 determined for the test item is greater than 2000 mg/kg b.w. The oral LD50 calculated for Propan-1-ol,2-amino-2-methyl-, 4-methylbenzenesulphonate was 918 mg/kg b.w.    The inhalation toxicity was determined in an OECD 436 guideline study using Wistar rats (strain Crl:WI (Han), Charles River Deutschland). Based on the experimentally results, the LC50 value for Propan-1-ol,2-amino-2-methyl-, 4-methylbenzenesulphonate is considered higher than 1979.9 mg/m3, which is the maximum technically achievable aerosol concentration resulting in a MMAD in the respirable range from 1-4 µm . ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5059266e-65d6-42c0-b7f4-428a38bed9a1/documents/414ceab7-912b-40ec-8f0d-7d6f04cdb7fb_d5eac7b6-655e-4e17-855d-9a7b1445af48.html,,,,,, "(2-hydroxy-1,1-dimethylethyl)ammonium toluene-4-sulphonate",68298-05-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5059266e-65d6-42c0-b7f4-428a38bed9a1/documents/414ceab7-912b-40ec-8f0d-7d6f04cdb7fb_d5eac7b6-655e-4e17-855d-9a7b1445af48.html,,oral,LD50,918 mg/kg bw,adverse effect observed, "(2-hydroxy-1,1-dimethylethyl)ammonium toluene-4-sulphonate",68298-05-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5059266e-65d6-42c0-b7f4-428a38bed9a1/documents/414ceab7-912b-40ec-8f0d-7d6f04cdb7fb_d5eac7b6-655e-4e17-855d-9a7b1445af48.html,,inhalation,LC50,"> 1,979.9 mg/m3",no adverse effect observed, (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxododecyl)amino]propyl]ammonium hydroxide,19223-55-3,"Following daily oral administration (by gavage) of the structural analogue C8-18 Cocamidopropyl hydroxysultaine, at dose levels of 0, 66.7, 200 and 600 mg/kg bw/day, to Wistar rats (10/sex/dose), for 90 days in a GLP OECD 408-compliant study, the NOAEL for systemic toxicity was considered to be 600 mg/kg bw/day (highest dose tested) based on the absence of systemic effects and the NOAEL for local effects was set at 66.7 mg/kg bw/day based on local irritation in the stomach considered to be due to the surfactant properties of the substance. Followingdaily oral administration (by gavage)of C8-18 alkylamidopropyl hydroxysultaineat dose levels of 0, 66.7, 200 and 600 mg/kg/day to Crl:WI Wistar Rats(10/gender/dose) for 90 days in a GLP OECD 408-compliant study, the NOAEL for systemic toxicity was considered to be 600 mg/kg bw/day (highest dose tested) based on the absence of systemic effects and the NOAEL for local effects was set at 66.7 mg/kg bw/day based on local irritation in the stomach considered to be due to surfactant properties of the registered substance.     Followingdaily oral administration (by gavage)of C8-18 alkylamidopropyl hydroxysultaineat dose levels of 0, 66.7, 200 and 600 mg/kg/day to Crl:WI Wistar Rats(10/gender/dose) for 90 days in a GLP OECD 408-compliant study, the NOAEL for systemic toxicity was considered to be 600 mg/kg bw/day (highest dose tested) based on the absence of systemic effects and the NOAEL for local effects was set at 66.7 mg/kg bw/day based on local irritation in the stomach considered to be due to surfactant properties of the registered substance. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a3848d5-4ee5-43ee-ab3f-ca4bad8bf68f/documents/6fe99752-58ac-4e27-bd21-bab0b40d6b07_fe4ba2e4-e707-424b-80f8-45d70b151cb0.html,,,,,, (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxododecyl)amino]propyl]ammonium hydroxide,19223-55-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a3848d5-4ee5-43ee-ab3f-ca4bad8bf68f/documents/6fe99752-58ac-4e27-bd21-bab0b40d6b07_fe4ba2e4-e707-424b-80f8-45d70b151cb0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxododecyl)amino]propyl]ammonium hydroxide,19223-55-3,"LD50 (rat, oral) = 3020 (females) or 2950 (genders combined) mg/kg bwLD50 (rat, dermal) > 2000 mg/kg(expressed as mg active ingredient) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a3848d5-4ee5-43ee-ab3f-ca4bad8bf68f/documents/fbc88998-9219-4491-b240-c2470a38a6ab_fe4ba2e4-e707-424b-80f8-45d70b151cb0.html,,,,,, (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxododecyl)amino]propyl]ammonium hydroxide,19223-55-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a3848d5-4ee5-43ee-ab3f-ca4bad8bf68f/documents/fbc88998-9219-4491-b240-c2470a38a6ab_fe4ba2e4-e707-424b-80f8-45d70b151cb0.html,,oral,LD50,"2,950 mg/kg bw",adverse effect observed, (2-hydroxy-3-sulphopropyl)dimethyl[3-[(1-oxododecyl)amino]propyl]ammonium hydroxide,19223-55-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a3848d5-4ee5-43ee-ab3f-ca4bad8bf68f/documents/fbc88998-9219-4491-b240-c2470a38a6ab_fe4ba2e4-e707-424b-80f8-45d70b151cb0.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, (2-hydroxyethyl)(3-hydroxypropyl)dimethylammonium chloride,78182-00-0,"Valid acute toxicity data for the oral route of exposure are available for the test item DMAC Trocken Flüssig.The test item was tested in Wistar rats according to the OECD TG 401 (1981) in BASFAG81/366 (1982). For the males, the LD50 was > 5000 mg/kg bwNo data are available for the dermal and the inhalative route of exposure.For the females, the LD50 was > 3160 — < 5000 mg/kg bw ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3dd66d29-44c4-4564-9721-d0faa5c01a30/documents/IUC5-9f6f7b70-472a-4850-859b-b2f3effdda74_47a42969-4aef-465f-9fbe-91642ca5170f.html,,,,,, (2-hydroxyethyl)ammonium nitrate,20748-72-5,"Based on key study results conducted with relevant source chemicals and following correction of mass proportions (read-across), the NOAEL/NOAEC for repeated oral/inhalation exposure to (2-Hydroxyethyl)ammonium nitrate was set at 382 mg/kg bw/day and 305 mg/m³, respectively. A repeated dose dermal toxicity study is not required for a reliable hazard assessment of systemic effects. No study is available for the reliable assessment of local effects associated with repeated exposure to (2-Hydroxyethyl)ammonium nitrate by the oral, inhalation or dermal route of exposure.Please refer also to the read-across and weight-of-evidence statement provided in section 13. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/503723bb-3542-42fa-969c-25094a8ab5d1/documents/IUC5-2537a290-6f98-4ee9-82f5-06da88b75b15_7186fac2-2b1b-424d-a9b1-46094efe6f3a.html,,,,,, (2-hydroxyethyl)ammonium nitrate,20748-72-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/503723bb-3542-42fa-969c-25094a8ab5d1/documents/IUC5-2537a290-6f98-4ee9-82f5-06da88b75b15_7186fac2-2b1b-424d-a9b1-46094efe6f3a.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,305 mg/m3,,rat (2-hydroxyethyl)ammonium nitrate,20748-72-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/503723bb-3542-42fa-969c-25094a8ab5d1/documents/IUC5-2537a290-6f98-4ee9-82f5-06da88b75b15_7186fac2-2b1b-424d-a9b1-46094efe6f3a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,382 mg/kg bw/day,,rat (2-hydroxypropyl)ammonium citrate,30798-32-4, The LD50 for acute oral toxicity of the substance was determined to exceed 5000 mg/kg bw in a GLP-compliant OECD 423 study. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a1241cb-c6fb-4674-a303-0896594fbf21/documents/63ce121c-ff47-4a04-ad96-a270178970e3_ddb2dbe6-7eed-4e00-891b-0924d022063b.html,,,,,, (2-hydroxypropyl)ammonium citrate,30798-32-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a1241cb-c6fb-4674-a303-0896594fbf21/documents/63ce121c-ff47-4a04-ad96-a270178970e3_ddb2dbe6-7eed-4e00-891b-0924d022063b.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate,62314-22-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Two publshed 90-day feeding studies using 2-EHA in rats and mice were perfomed in equivalence to OECD guidelines and showed similar effects. No GLP although studies are wel documentd and peer reviewed. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5bab90ab-c74c-4fcd-b1e8-f3fb17083d77/documents/b29517c1-7a3b-4306-bb3d-26fd4a1ea504_1decbbed-2316-423d-abd6-d81d993f2f4a.html,,,,,, (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate,62314-22-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5bab90ab-c74c-4fcd-b1e8-f3fb17083d77/documents/b29517c1-7a3b-4306-bb3d-26fd4a1ea504_1decbbed-2316-423d-abd6-d81d993f2f4a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,61 mg/kg bw/day,,rat (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate,62314-22-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): 2016 Guideline study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Waiver on basis of substance corrosivity. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): 1975 non-guideline study on product containing test substance. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5bab90ab-c74c-4fcd-b1e8-f3fb17083d77/documents/4806fc9a-e2b9-40e2-a8fa-94d1b3686f96_1decbbed-2316-423d-abd6-d81d993f2f4a.html,,,,,, (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate,62314-22-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5bab90ab-c74c-4fcd-b1e8-f3fb17083d77/documents/4806fc9a-e2b9-40e2-a8fa-94d1b3686f96_1decbbed-2316-423d-abd6-d81d993f2f4a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, (2-hydroxypropyl)trimethylammonium 2-ethylhexanoate,62314-22-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5bab90ab-c74c-4fcd-b1e8-f3fb17083d77/documents/4806fc9a-e2b9-40e2-a8fa-94d1b3686f96_1decbbed-2316-423d-abd6-d81d993f2f4a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, (2-hydroxypropyl)trimethylammonium formate,62314-25-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f430108-9ee9-4153-98f5-d5b8da6c02f5/documents/bd241aa6-0ae4-4732-bf22-60a32f21065b_6c3b3735-0c0a-4089-96e8-c2c81543ed5d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat (2-hydroxypropyl)trimethylammonium formate,62314-25-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Based on 2016 Guideline study (OECD 423) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): 1976 non-guideline study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): 1976 non-guideline study ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f430108-9ee9-4153-98f5-d5b8da6c02f5/documents/a6536aec-5c36-4a05-b8bd-176d9cdaea82_6c3b3735-0c0a-4089-96e8-c2c81543ed5d.html,,,,,, (2-hydroxypropyl)trimethylammonium formate,62314-25-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f430108-9ee9-4153-98f5-d5b8da6c02f5/documents/a6536aec-5c36-4a05-b8bd-176d9cdaea82_6c3b3735-0c0a-4089-96e8-c2c81543ed5d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, (2-hydroxypropyl)trimethylammonium formate,62314-25-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f430108-9ee9-4153-98f5-d5b8da6c02f5/documents/a6536aec-5c36-4a05-b8bd-176d9cdaea82_6c3b3735-0c0a-4089-96e8-c2c81543ed5d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, (2-hydroxypropyl)trimethylammonium formate,62314-25-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f430108-9ee9-4153-98f5-d5b8da6c02f5/documents/a6536aec-5c36-4a05-b8bd-176d9cdaea82_6c3b3735-0c0a-4089-96e8-c2c81543ed5d.html,,inhalation,LC50,"7,500 mg/m3",no adverse effect observed, (2-methyl-5-propan-2-ylcyclopentyl) propanoate,1245725-35-2," Oral LD50 > 2000 mg/kg bw (OECD 423, K, Rel.2) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5544eb20-6700-4509-9949-c1df9a343c98/documents/e31dc337-632b-4b3e-b823-b455ffafd286_02aabb57-ff8b-476b-8231-1b31e441e659.html,,,,,, (2-methyl-5-propan-2-ylcyclopentyl) propanoate,1245725-35-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5544eb20-6700-4509-9949-c1df9a343c98/documents/e31dc337-632b-4b3e-b823-b455ffafd286_02aabb57-ff8b-476b-8231-1b31e441e659.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(2R)-2-(2,4-difluorophenyl)-1,1-difluoro-1-{5-[4-(2,2,2-trifluoroethoxy)phenyl]pyridin-2-yl}-3-(1H-tetrazol-1-yl)propan-2-ol",1340593-59-0," In an acute oral toxicity study (acute toxic class method, OECD 423), three groups of fasted, 8-9 weeks old, female Wistar rats (3 rats/step) were given a single oral dose of (2R)-2-(2,4-difluorophenyl)-1,1-difluoro-3-(tetrazol-1-yl)-1-[5-[4-(2,2,2-trifluoroethoxy)phenyl]pyridin-2-yl]propan-2-ol in corn oil at 300 (step 2 and 3) or 2000 mg/kg bw (step 1) and were observed for 14 days. Based on the results and in accordance with OECD guideline 423, the LD50 cut-off value was determined to be 500 mg/kg bw. Thus, the substance meets the criteria of the CLP regulation 1272/2008 for being classified as Acute Tox. 4, H302. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de0a1826-3d6e-4644-b23c-c9819c4b3cbc/documents/ba3b6a0c-2695-4c99-9766-ec1f355d05e8_4d0a77b8-12fb-46a6-9764-6fdd51d45fff.html,,,,,, "(2R)-2-(2,4-difluorophenyl)-1,1-difluoro-1-{5-[4-(2,2,2-trifluoroethoxy)phenyl]pyridin-2-yl}-3-(1H-tetrazol-1-yl)propan-2-ol",1340593-59-0,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de0a1826-3d6e-4644-b23c-c9819c4b3cbc/documents/ba3b6a0c-2695-4c99-9766-ec1f355d05e8_4d0a77b8-12fb-46a6-9764-6fdd51d45fff.html,,oral,LD50,500 mg/kg bw,adverse effect observed, (3R)-3-aminobutan-1-ol-(2S)-2-hydroxy-2-phenyl-acetate,1236049-43-6,"LD50 (oral,rat): > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6b34d8c-85ae-463d-9ecb-2f5d82d69818/documents/IUC5-1d2cf384-b0e7-4c1a-9e46-14ec4592bc4a_45745af1-04dc-45d8-b632-adf2fccfe7cc.html,,,,,, (3R)-3-aminobutan-1-ol-(2S)-2-hydroxy-2-phenyl-acetate,1236049-43-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6b34d8c-85ae-463d-9ecb-2f5d82d69818/documents/IUC5-1d2cf384-b0e7-4c1a-9e46-14ec4592bc4a_45745af1-04dc-45d8-b632-adf2fccfe7cc.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "(2R,3R,11bR)-3-Isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2H-pyrido[2,1-a]isoquinolin-2-yl L-valinate dihydrochloride",1639208-51-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Maximum Tolerated Acute Dose Oral /Rat <60 mg/kg Maximum Tolerated Acute Dose Oral /Dog 50 mg/kg In single dose studies in dogs and rats, morbidity was associated with a dose of 80 and >100 mg/kg NBI-98854, respectively ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7605b87-41a0-4672-a466-0396816691ef/documents/ee3e9ed0-6276-493c-920c-2656717e74c6_f49e092f-9cd6-46ac-90cf-cdee2ff0059d.html,,,,,, "(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-erythro-hexopyranosyl-4-ulose)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,8,10,12,14-hexamethyl-15-oxo-1-oxa-6-azacyclopentadecan-11-yl 2-O-[(benzyloxy)carbonyl]-3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranoside trifluoroacetate (1:2)",1210740-88-7,Data from the Supplier. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d800166-22ff-44b7-a982-56097ee8939c/documents/b698d57c-56be-4363-b63a-808b31f1670f_d3f6c579-293f-445a-9c6b-3a5f05f3ed79.html,,,,,, "(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-erythro-hexopyranosyl-4-ulose)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,8,10,12,14-hexamethyl-15-oxo-1-oxa-6-azacyclopentadecan-11-yl 2-O-[(benzyloxy)carbonyl]-3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranoside trifluoroacetate (1:2)",1210740-88-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d800166-22ff-44b7-a982-56097ee8939c/documents/b698d57c-56be-4363-b63a-808b31f1670f_d3f6c579-293f-445a-9c6b-3a5f05f3ed79.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-13-[(2,6-dideoxy-3-C-methyl-3-O-methyl-α-L-erythro-hexopyranosyl-4-ulose)oxy]-2-ethyl-3,4,10-trihydroxy-3,5,8,10,12,14-hexamethyl-15-oxo-1-oxa-6-azacyclopentadecan-11-yl 2-O-[(benzyloxy)carbonyl]-3,4,6-trideoxy-3-(dimethylamino)-β-D-xylo-hexopyranoside trifluoroacetate (1:2)",1210740-88-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d800166-22ff-44b7-a982-56097ee8939c/documents/b698d57c-56be-4363-b63a-808b31f1670f_d3f6c579-293f-445a-9c6b-3a5f05f3ed79.html,,dermal,LD50,"ca.2,000 mg/kg bw",no adverse effect observed, "(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10-trihydroxy-13-{[(3S,4S,6R,8R)-8-methoxy-4,8-dimethyl-1,5-dioxaspiro[2.5]oct-6-yl]oxy}-3,5,8,10,12,14-hexamethyl-15-oxo-1-oxa-6-azacyclopentadecan-11-yl 3,4,6-trideoxy-3-(dimethylamino)--D-xylo-hexopyranoside",217500-75-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8053ee4e-c177-4b53-ac4e-28e06e541cf7/documents/f8cd099c-5c44-4c78-b742-ef0a3640898a_03d689bc-5cd1-4f20-b1e6-cc4e3227aac6.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(2R,3S,4R,5R,8R,10R,11R,12S,13S,14R)-2-ethyl-3,4,10-trihydroxy-13-{[(3S,4S,6R,8R)-8-methoxy-4,8-dimethyl-1,5-dioxaspiro[2.5]oct-6-yl]oxy}-3,5,8,10,12,14-hexamethyl-15-oxo-1-oxa-6-azacyclopentadecan-11-yl 3,4,6-trideoxy-3-(dimethylamino)--D-xylo-hexopyranoside",217500-75-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8053ee4e-c177-4b53-ac4e-28e06e541cf7/documents/f8cd099c-5c44-4c78-b742-ef0a3640898a_03d689bc-5cd1-4f20-b1e6-cc4e3227aac6.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, (-)-(2S)-1-Isopropoxy-1-oxo-2-propanyl pivalate,1584709-99-8," Repeated dose toxicity oral: NOAEL = 1000 mg/kg bw/d (OECD 407, GLP, K, rel. 1) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd27e8a5-9e24-4ade-8eb4-f5d6bf8504dd/documents/96ae60f0-b54d-458b-8dbb-51a4b7dbe744_68b401ca-70c7-4870-a157-c0c27074291e.html,,,,,, (-)-(2S)-1-Isopropoxy-1-oxo-2-propanyl pivalate,1584709-99-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd27e8a5-9e24-4ade-8eb4-f5d6bf8504dd/documents/96ae60f0-b54d-458b-8dbb-51a4b7dbe744_68b401ca-70c7-4870-a157-c0c27074291e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat (-)-(2S)-1-Isopropoxy-1-oxo-2-propanyl pivalate,1584709-99-8," Oral LD50 > 2000 mg/kg bw (OECD 423, K, Rel.1, class method in rats) Dermal LD50 > 2000 mg/kg bw (OECD 402, K, Rel.1, limit test in rats) Inhalation LC50 > 6.74 mg/L (= 6740 mg/m3) (OECD 403, K, Rel.1, limit test/nose only in rats) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd27e8a5-9e24-4ade-8eb4-f5d6bf8504dd/documents/8b3f7fc3-34ce-47d0-9efd-dd5e40cf7363_68b401ca-70c7-4870-a157-c0c27074291e.html,,,,,, (-)-(2S)-1-Isopropoxy-1-oxo-2-propanyl pivalate,1584709-99-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd27e8a5-9e24-4ade-8eb4-f5d6bf8504dd/documents/8b3f7fc3-34ce-47d0-9efd-dd5e40cf7363_68b401ca-70c7-4870-a157-c0c27074291e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, (-)-(2S)-1-Isopropoxy-1-oxo-2-propanyl pivalate,1584709-99-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd27e8a5-9e24-4ade-8eb4-f5d6bf8504dd/documents/8b3f7fc3-34ce-47d0-9efd-dd5e40cf7363_68b401ca-70c7-4870-a157-c0c27074291e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, (-)-(2S)-1-Isopropoxy-1-oxo-2-propanyl pivalate,1584709-99-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd27e8a5-9e24-4ade-8eb4-f5d6bf8504dd/documents/8b3f7fc3-34ce-47d0-9efd-dd5e40cf7363_68b401ca-70c7-4870-a157-c0c27074291e.html,,inhalation,LC50,"6,740 mg/m3",no adverse effect observed, (2S)-2-[(4-Chlorobenzoyl)oxy]propanoic acid,1047975-16-5," Supplier data. Acute Oral LD50 (mouse) > 2,000mg/kg ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6e391d3-e83b-448d-8482-2fe956e84144/documents/4feeac9a-aa2d-4c11-9ea6-923b7c9fb0cb_4edcc936-8c03-428d-9c21-a4ea1c5d696f.html,,,,,, "(2S)-2-amino-3-[3,5-diiodo-4-(4-methoxyphenoxy)phenyl]propanoic acid",94345-95-6, An acute toxic class method was carried out: No death occurred at 2000 mg/kg bw single oral dose of O-METHYL-L-DIIODOTHYRONIN. All female rats in step 1 and step 2 survived until the end of the 14-day observation period. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04863443-4997-4e4d-aa70-dde237e95a62/documents/6e984f98-fce3-434b-8b3b-049d93a71bda_d6096952-5f5c-47be-bb67-8b5559df9aa3.html,,,,,, "(2S)-2-amino-3-[3,5-diiodo-4-(4-methoxyphenoxy)phenyl]propanoic acid",94345-95-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04863443-4997-4e4d-aa70-dde237e95a62/documents/6e984f98-fce3-434b-8b3b-049d93a71bda_d6096952-5f5c-47be-bb67-8b5559df9aa3.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, (2S)-5-amino-2-[(aminoacetyl)amino]-5-oxopentanoic acid,13115-71-4,"In a 14-day Dose Range Finding (DRF) toxicity study where Glycyl-L-Glutamine was administered by oral gavage to Wistar rats for 14 consecutive days, at 1000 mg/kg bw/day there were no specific adverse effects identified. The daily administration of Glycyl-L-Glutamine anhydrous by oral gavage to Wistar rats at dose levels up to 1000 mg/kg bw/day in a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to OECD TG 422 did not result in any toxicological relevant finding. Thus, the overall NOEL of this study is 1000 mg/kg bw/day covering systemic and reproductive toxicity of the parenteral generation as well as development and survival of the F1 generation. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): This study followed the procedures indicated by the following internationally accepted guideline and recommendations: • OECD Guideline No. 422, Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test in the Rat (2016) • OECD No. 43 Guidance Document on Mammalian Reproductive Toxicity Testing and Assessment (2008) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a543d28a-0813-490b-96f8-7e7ac31b09e6/documents/3e10407b-ae95-495c-a440-f20ff2e1c8f8_760c876c-bfb4-44f1-bb16-fc5c15abda54.html,,,,,, (2S)-5-amino-2-[(aminoacetyl)amino]-5-oxopentanoic acid,13115-71-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a543d28a-0813-490b-96f8-7e7ac31b09e6/documents/3e10407b-ae95-495c-a440-f20ff2e1c8f8_760c876c-bfb4-44f1-bb16-fc5c15abda54.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat (2S)-5-amino-2-[(aminoacetyl)amino]-5-oxopentanoic acid,13115-71-4," Oral (OECD 401), rat, LD50 (m, f) > 5110 mg/kg bw (test item glycyl-L-glutamine monohydrate), equivalent to 4879 mg/kg bw anhydrous glycyl-L-glutamine ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a543d28a-0813-490b-96f8-7e7ac31b09e6/documents/IUC5-a0f6b74e-97d7-47f6-8580-daefdcbb0450_760c876c-bfb4-44f1-bb16-fc5c15abda54.html,,,,,, (2S)-5-amino-2-[(aminoacetyl)amino]-5-oxopentanoic acid,13115-71-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a543d28a-0813-490b-96f8-7e7ac31b09e6/documents/IUC5-a0f6b74e-97d7-47f6-8580-daefdcbb0450_760c876c-bfb4-44f1-bb16-fc5c15abda54.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(2S,3S)-2-benzhydryl-N-[(5-tert-butyl-2-methoxy-phenyl)methyl]quinuclidin-3-amine",147116-67-4,"Repeated oral toxicity: The oral administration of test item to rats produced persistent salivation, dose­ dependent decreased body weight gain, and upper respiratory (raspy breathing) and secondary pulmonary tract changes at 30 and 150 mg/kg/day. The respiratory changes were possibly initiated by topical irritant effects of the compound when administered by oral gavage, and most likely contributed to four deaths at 150 mg/kg/day. Liver weights were higher at 30 and 150 mg/kg/day, with hepatocellular hypertrophy and hepatic microsomal enzyme induction noted at the high dose. No changes occurred at 5 mg/kg/day except for transient and minor occurrences of raspy breathing, possibly a consequence of topical effects of the compound. Based upon these data, 5 mg/kg/day was identified as a ""no observed adverse effect level"" (NOAEL) in this 93-day oral toxicity study in rats with test item. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efeaef7d-5298-4e97-b556-f7d1c5f1442a/documents/63a3986a-b4b5-4b43-a5a6-bd92ad5b56ca_d3815438-4cec-49e0-99af-50b26b943e24.html,,,,,, "(2S,3S)-2-benzhydryl-N-[(5-tert-butyl-2-methoxy-phenyl)methyl]quinuclidin-3-amine",147116-67-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efeaef7d-5298-4e97-b556-f7d1c5f1442a/documents/63a3986a-b4b5-4b43-a5a6-bd92ad5b56ca_d3815438-4cec-49e0-99af-50b26b943e24.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat "(2S,3S)-2-benzhydryl-N-[(5-tert-butyl-2-methoxy-phenyl)methyl]quinuclidin-3-amine",147116-67-4,"Oral: The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley rat was estimated as being greater than 2000 mg/kg bodyweight. Dermal: The acute dermal median lethal dose (LD50) of the test material, in the Sprague-Dawley rat was found to be greater than 2000 mg/kg bodyweight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efeaef7d-5298-4e97-b556-f7d1c5f1442a/documents/5592451e-bf42-44f7-8128-d57021935401_d3815438-4cec-49e0-99af-50b26b943e24.html,,,,,, "(2S,3S)-2-benzhydryl-N-[(5-tert-butyl-2-methoxy-phenyl)methyl]quinuclidin-3-amine",147116-67-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efeaef7d-5298-4e97-b556-f7d1c5f1442a/documents/5592451e-bf42-44f7-8128-d57021935401_d3815438-4cec-49e0-99af-50b26b943e24.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(2S,3S)-2-benzhydryl-N-[(5-tert-butyl-2-methoxy-phenyl)methyl]quinuclidin-3-amine",147116-67-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efeaef7d-5298-4e97-b556-f7d1c5f1442a/documents/5592451e-bf42-44f7-8128-d57021935401_d3815438-4cec-49e0-99af-50b26b943e24.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(3-acetyloxy-2,2-dimethylpropyl) acetate",13431-57-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc81aa78-4406-4fec-bd5d-a50d2c5dd4b9/documents/6c84693e-4340-4905-868d-3a4101e7f7bc_fe8f58fd-ac6e-4c70-bc11-7cfd973bdfd0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "(3-acetyloxy-2,2-dimethylpropyl) acetate",13431-57-7,Under the conditions of an OECD 423 compliant GLP study the oral LD50 was found to be larger than 2000 mg/kg in rats. Under the conditions of an OECD 403 compliant GLP study the inhalation LC50 was found to be greater than 5.475 mg/L in male and female rats. Under the conditions of an OECD 402 compliant GLP study the dermal LD50 was found to be greater than 2000 mg/kg bw in male and female rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc81aa78-4406-4fec-bd5d-a50d2c5dd4b9/documents/6928c6ab-5c28-410f-a65d-c27f2d273642_fe8f58fd-ac6e-4c70-bc11-7cfd973bdfd0.html,,,,,, "(3-acetyloxy-2,2-dimethylpropyl) acetate",13431-57-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc81aa78-4406-4fec-bd5d-a50d2c5dd4b9/documents/6928c6ab-5c28-410f-a65d-c27f2d273642_fe8f58fd-ac6e-4c70-bc11-7cfd973bdfd0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(3-acetyloxy-2,2-dimethylpropyl) acetate",13431-57-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc81aa78-4406-4fec-bd5d-a50d2c5dd4b9/documents/6928c6ab-5c28-410f-a65d-c27f2d273642_fe8f58fd-ac6e-4c70-bc11-7cfd973bdfd0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "(3-acetyloxy-2,2-dimethylpropyl) acetate",13431-57-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc81aa78-4406-4fec-bd5d-a50d2c5dd4b9/documents/6928c6ab-5c28-410f-a65d-c27f2d273642_fe8f58fd-ac6e-4c70-bc11-7cfd973bdfd0.html,,inhalation,LC50,> 5.475 mg/L,no adverse effect observed, (3-aminophenyl)urea,25711-72-2, LD50 was estimated to be 3055 mg/kg bw when Wistar female rats were orally exposed with 1-(3-aminophenyl)urea. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81879aa1-48bb-4dbd-985e-6dde2ec08f45/documents/cc354fdb-784e-4047-ac5f-c1f9b23cd4af_82c1db08-fd0d-4a18-ad9f-af95a8d4e203.html,,,,,, (3-aminophenyl)urea,25711-72-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81879aa1-48bb-4dbd-985e-6dde2ec08f45/documents/cc354fdb-784e-4047-ac5f-c1f9b23cd4af_82c1db08-fd0d-4a18-ad9f-af95a8d4e203.html,,oral,LD50,"3,055 mg/kg bw",no adverse effect observed, (3-aminophenyl)uronium chloride,59690-88-9,The acute oral median lethal dose (LD50) of (3-aminophenyl)uronium chloride in Rat (Wistar) was estimated to be 2680.05 mg/kg bw. This value indicates that (3-aminophenyl)uronium chloride does not exhibits acute toxicity by the oral route in accordance to the criteria laid down by the CLP regulation. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93eb9083-35c0-4713-bf74-4396d9d21e97/documents/IUC5-883f1dfb-82a5-4592-a192-da223189c897_541aae10-ea93-4761-89c0-50bd7e7a859f.html,,,,,, (3-aminophenyl)uronium chloride,59690-88-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93eb9083-35c0-4713-bf74-4396d9d21e97/documents/IUC5-883f1dfb-82a5-4592-a192-da223189c897_541aae10-ea93-4761-89c0-50bd7e7a859f.html,,oral,LD50,"2,680.05 mg/kg bw",no adverse effect observed, "(3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene",2825-82-3," Repeated dose toxicity: oral: NOAEL = 15000 ppm (equivalent to 1205 mg/kg/day in males and 1165 mg/kg/day in females), (OECD 407, GLP, K, rel. 1) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c872b616-287d-4041-90e2-39d72aafecf1/documents/d7fa5dc8-0781-446b-a531-2936350645ab_a3ca9457-f379-46ed-8a46-732b3b811827.html,,,,,, "(3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene",2825-82-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c872b616-287d-4041-90e2-39d72aafecf1/documents/d7fa5dc8-0781-446b-a531-2936350645ab_a3ca9457-f379-46ed-8a46-732b3b811827.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,165 mg/kg bw/day",,rat "(3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene",2825-82-3," - Acute oral toxicity: LD50 (rats, hamsters) > 20 mL/kg bw, ca. 18.8 g/kg bw ; LD50(mice) = 3.9 mL/kg bw, ca. 2.8 g/kg bw (No guideline; rel.2, K) - Acute inhalation toxicity: LC50 (Male rats) = 1221 (1174 -1259) ppm, ca. 6.803 (6.542 - 7.015) mg/L ; LC50 (Female rats) = 1194 (1107 -1287) ppm, ca. 6.653 (6.168 - 7.171) mg/L (No guideline; rel.2, K). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c872b616-287d-4041-90e2-39d72aafecf1/documents/035503ee-2ceb-4ba2-97fd-da9a3d448256_a3ca9457-f379-46ed-8a46-732b3b811827.html,,,,,, "(3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene",2825-82-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c872b616-287d-4041-90e2-39d72aafecf1/documents/035503ee-2ceb-4ba2-97fd-da9a3d448256_a3ca9457-f379-46ed-8a46-732b3b811827.html,,oral,LD50,"2,800 mg/kg bw",no adverse effect observed, "(3aα,4β,7β,7aα)-octahydro-4,7-methano-1H-indene",2825-82-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c872b616-287d-4041-90e2-39d72aafecf1/documents/035503ee-2ceb-4ba2-97fd-da9a3d448256_a3ca9457-f379-46ed-8a46-732b3b811827.html,,inhalation,LC50,"6,653 mg/m3",adverse effect observed, (3-chloropropyl)diethoxymethylsilane,13501-76-3,"There are no measured repeated dose toxicity data on (3-chloropropyl)diethoxymethylsilane, therefore, the structural analogue substance (3-chloropropyl)trimethoxysilane (CAS: 2530-87-2) has been used to assess the systemic toxicity potential of (3-chloropropyl)diethoxymethylsilane (MW ratio: target/source = 1.06).Repeated dose toxicity:Inhalation, subchronic:according to OECD TG 413 in rats: NOAEC = 804.6 mg/m³ (99.7 ppm)MW corrected NOAEC = 853.38 mg/m³Inhalation, subacute:according to OECD TG 422 in rats: NOAEC = ≥804.6 mg/m³ (99.7 ppm) MW corrected NOAEC = ≥ 853.38 mg/m³ ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf864f90-aca3-4217-a38e-d8d80ddf19dd/documents/IUC5-6088a3ff-dbf0-45c7-9611-c19330a519bd_260b276f-0a2c-4d6f-a699-ac73cc1a905c.html,,,,,, (3-chloropropyl)diethoxymethylsilane,13501-76-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf864f90-aca3-4217-a38e-d8d80ddf19dd/documents/IUC5-6088a3ff-dbf0-45c7-9611-c19330a519bd_260b276f-0a2c-4d6f-a699-ac73cc1a905c.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,853.38 mg/m3,,rat (3-chloropropyl)diethoxymethylsilane,13501-76-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf864f90-aca3-4217-a38e-d8d80ddf19dd/documents/IUC5-6088a3ff-dbf0-45c7-9611-c19330a519bd_260b276f-0a2c-4d6f-a699-ac73cc1a905c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,853.38 mg/m3,no adverse effect observed, (3-chloropropyl)diethoxymethylsilane,13501-76-3,"Oral (OECD TG 401), rat: LD50 > 2000 mg/kg bw (limit test)Dermal: (OECD TG 402), rat: LD50 > 2000 mg/kg bw (limit test) Inhalation: No measured data are available. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf864f90-aca3-4217-a38e-d8d80ddf19dd/documents/IUC5-7ffbcde9-8fa6-48ef-b938-dd7a41984e73_260b276f-0a2c-4d6f-a699-ac73cc1a905c.html,,,,,, (3-chloropropyl)dimethoxymethylsilane,18171-19-2," There are no repeated dose toxicity data on 3-chloropropyl(dimethoxy)methylsilane (CAS 18171-19-2; EC No. 242-056-0) or its hydrolysis product, 3-chloropropyl(methyl)silanediol. A subchronic (90-day) repeated dose toxicity study with the registered substance 3-chloropropyl(dimethoxy)methylsilane, according to OECD Test Guideline 408 is ongoing and the dossier will be updated to include this study when it is completed. As an interim approach, read-across data for a structural analogue have been used to allow risk characterisation. Reliable data for the related substance (3-chloropropyl)trimethoxysilane (CAS 2530-87-2) have been used to assess the general systemic toxicity of 3-chloropropyl(dimethoxy)methylsilane in order to perform interim risk characterisation. In a 90-day inhalation study (Dow Corning Corporation, 1993, Reliabilty Score 1) in rats, conducted according to OECD Test Guideline 413 and in compliance with GLP, the NOAEC for (3-chloropropyl)trimethoxysilane was determined to be ≥100 ppm (813 mg/m3). There are no data for the oral or dermal routes. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f82c4d41-525a-43d8-9c37-fccb0ad229db/documents/d66b21f4-5442-4d31-a789-bbc718a5a72d_23c39b0e-24cc-45b8-8d8b-50ed32b93104.html,,,,,, (3-chloropropyl)dimethoxymethylsilane,18171-19-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f82c4d41-525a-43d8-9c37-fccb0ad229db/documents/d66b21f4-5442-4d31-a789-bbc718a5a72d_23c39b0e-24cc-45b8-8d8b-50ed32b93104.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,813 mg/m3,,rat (3-chloropropyl)dimethoxymethylsilane,18171-19-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f82c4d41-525a-43d8-9c37-fccb0ad229db/documents/d66b21f4-5442-4d31-a789-bbc718a5a72d_23c39b0e-24cc-45b8-8d8b-50ed32b93104.html,Repeated dose toxicity – local effects,inhalation,NOAEC,813 mg/m3,no adverse effect observed,rat (3-chloropropyl)dimethoxymethylsilane,18171-19-2," In an acute toxic class study, conducted to OECD Test Guideline 423 and in compliance with GLP (LPT, 2002a, Reliability Score 1), the acute oral LD50 of 3-chloropropyl(dimethoxy)methylsilane (CAS 18171 -19 -2; EC No. 242 -056 -0) was in the range 200-2000 mg/kg bw in rats.   There are no measured acute dermal toxicity data for 3-chloropropyl(dimethoxy)methylsilane. Therefore, data have been read across from the structurally-related 3-chloropropyl(diethoxy)methylsilane. In an acute dermal limit study (Hüls AG, 1997b), conducted according to OECD Test Guideline 402 and in compliance with GLP, the dermal acute LD50 for the related substance, 3-chloropropyl(diethoxy)methylsilane was greater than 2000 mg/kg bw in Wistar rats. There are no acute inhalation studies on 3-chloropropyl(dimethoxy)methylsilane or related analogue substances. An acute dermal toxicity study conducted according to OECD Test Guideline 402 will be conducted and added to the dossier when available. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f82c4d41-525a-43d8-9c37-fccb0ad229db/documents/7bfa9d36-d16e-4e41-82ad-f6256a9bed1a_23c39b0e-24cc-45b8-8d8b-50ed32b93104.html,,,,,, (3-chloropropyl)dimethoxymethylsilane,18171-19-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f82c4d41-525a-43d8-9c37-fccb0ad229db/documents/7bfa9d36-d16e-4e41-82ad-f6256a9bed1a_23c39b0e-24cc-45b8-8d8b-50ed32b93104.html,,oral,LD50,200 mg/kg bw,adverse effect observed, (3-chloropropyl)dimethoxymethylsilane,18171-19-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f82c4d41-525a-43d8-9c37-fccb0ad229db/documents/7bfa9d36-d16e-4e41-82ad-f6256a9bed1a_23c39b0e-24cc-45b8-8d8b-50ed32b93104.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, (3-chloropropyl)triethoxysilane,5089-70-3," No reliable repeated-dose toxicity data are available for (3-chloropropyl)triethoxysilane (CAS 5089-70-3). A 90-day repeated dose toxicity study by the oral route with the registered substance according to OECD Test Guideline 408 and in compliance with GLP is proposed. Good quality data from the analogous substance (3-chloropropyl)trimethoxysilane (CAS 2530-87-2) is included and used as read-across for interim risk assessment. After approval by ECHA and once the results from the OECD Test Guideline 408 are available, the DNELs will be revised. In a 90-day inhalation study in rats with (3-chloropropyl)trimethoxysilane, conducted according to OECD Test Guideline 413 and in compliance with GLP, the systemic NOAEC was determined to be 100 ppm (813 mg/m³) and the local NOAEC was determined to be = 100 ppm (Dow Corning Corporation, 1993). In a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test with (3-chloropropyl)trimethoxysilane, conducted according to OECD Test Guideline 422 and in compliance with GLP, by the inhalation route, whole-body in rats, the NOAEC was established to be at least 100 ppm (813 mg/m³) based on no observed toxicity (RCC, 2005). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41542a90-4466-4806-aa0d-cab056a9839a/documents/f80d803e-7b9d-46ac-91f6-adae7c06753a_bf7562fe-5724-47c3-b436-ce7a7ade0a22.html,,,,,, (3-chloropropyl)triethoxysilane,5089-70-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41542a90-4466-4806-aa0d-cab056a9839a/documents/f80d803e-7b9d-46ac-91f6-adae7c06753a_bf7562fe-5724-47c3-b436-ce7a7ade0a22.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,813 mg/m3,,rat (3-chloropropyl)triethoxysilane,5089-70-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41542a90-4466-4806-aa0d-cab056a9839a/documents/f80d803e-7b9d-46ac-91f6-adae7c06753a_bf7562fe-5724-47c3-b436-ce7a7ade0a22.html,Repeated dose toxicity – local effects,inhalation,NOAEC,813 mg/m3,no adverse effect observed,rat (3-chloropropyl)triethoxysilane,5089-70-3," In the key acute oral toxicity study with (3-chloropropyl)triethoxysilane (CAS 5089-70-3; EC 225-805-6) conducted according to EPA OPP 81-1 Test Guideline (similar to the now deleted OECD Test Guideline 401) and in compliance with GLP, the LD50 was concluded to be at least 5000 mg/kg bw in male and female rats (WIL Research Laboratories Inc., 1996a). In the key acute dermal toxicity study with (3-chloropropyl)triethoxysilane, conducted according to EPA OPP81-2 Test Guideline (similar to OECD Test Guideline 402) and in compliance with GLP, the LD50 was concluded to be greater than 2000 mg/kg bw in male and female rats. Transient local effect were reported (WIL Research Laboratories Inc., 1996b). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41542a90-4466-4806-aa0d-cab056a9839a/documents/5759c95e-d4ce-4009-9666-9a0dae81bed8_bf7562fe-5724-47c3-b436-ce7a7ade0a22.html,,,,,, "(3E)-3-[[4-(2-carboxyethylcarbamoyl)phenyl]hydrazinylidene]-6-oxocyclohexa-1,4-diene-1-carboxylic acid",80573-04-2," Repeat dose short-term, sub-chronic and chronic toxicity studies are available. The results show that balsalazide disodium, and hence balsalazide acid, are of low toxicological concern. The short term toxicity studies performed in rats and dogs did not produce any treatment related effects up to the highest dose tested (2000 mg/kg bw/day). In the longer term studies, 26 and 96 weeks in rats, adverse effects were seen in the stomach, kidney and bladder. However, these effects indicated low systemic toxicity of the test substance and hence balsalazide acid. In the 96 week study, these effects manifested themselves at dose levels of 100 and 500 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/368b0a72-02c2-4909-8572-310728f84ea9/documents/64531cf9-4a4c-4953-8b4c-f3940e6f2397_d726ac90-5aca-40db-af3d-f32c13671bfe.html,,,,,, "(3E)-3-[[4-(2-carboxyethylcarbamoyl)phenyl]hydrazinylidene]-6-oxocyclohexa-1,4-diene-1-carboxylic acid",80573-04-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/368b0a72-02c2-4909-8572-310728f84ea9/documents/64531cf9-4a4c-4953-8b4c-f3940e6f2397_d726ac90-5aca-40db-af3d-f32c13671bfe.html,Chronic toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat "(3E)-3-[[4-(2-carboxyethylcarbamoyl)phenyl]hydrazinylidene]-6-oxocyclohexa-1,4-diene-1-carboxylic acid",80573-04-2," The acute oral toxicity studies show that Balsalazide disodium and hence balsalazide acid are not toxic when administered to rats as a single oral dose of 2000 and 5000 mg/kg bw. No mortalities, adverse effects or clinical signs were observed during the studies. Therefore, the highest doses tested were considered to be the non-lethal doses and the LD50 in rats is considered to be greater than 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/368b0a72-02c2-4909-8572-310728f84ea9/documents/fda19a9d-99b9-404b-b792-3bfff67a8e45_d726ac90-5aca-40db-af3d-f32c13671bfe.html,,,,,, "(3E)-3-[[4-(2-carboxyethylcarbamoyl)phenyl]hydrazinylidene]-6-oxocyclohexa-1,4-diene-1-carboxylic acid",80573-04-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/368b0a72-02c2-4909-8572-310728f84ea9/documents/fda19a9d-99b9-404b-b792-3bfff67a8e45_d726ac90-5aca-40db-af3d-f32c13671bfe.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, (3E)-dec-3-en-2-one,18402-84-1," In a short-term repeated dose inhalation study, (3E)-3 -decen-2 -one was given by inhalation administration to CRL:CD(SD) rats, six hours daily, for variable durations. Administration for 5 consecutive days was performed at achieved exposure levels of 139, 278 and 531 μg/L. Based on the findings, the NOAEC is considered to be 139 μg/L. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c72f325-d195-4769-a098-31823aeab8bd/documents/a5967e0e-d48c-41e6-b1d6-be0fc0aa6925_b50272d0-91cb-4370-b631-6384216bbb71.html,,,,,, (3E)-dec-3-en-2-one,18402-84-1,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c72f325-d195-4769-a098-31823aeab8bd/documents/a5967e0e-d48c-41e6-b1d6-be0fc0aa6925_b50272d0-91cb-4370-b631-6384216bbb71.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,139 mg/m3,,rat (3E)-dec-3-en-2-one,18402-84-1,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c72f325-d195-4769-a098-31823aeab8bd/documents/a5967e0e-d48c-41e6-b1d6-be0fc0aa6925_b50272d0-91cb-4370-b631-6384216bbb71.html,Repeated dose toxicity – local effects,inhalation,NOAEC,139 mg/m3,adverse effect observed,rat (3E)-dec-3-en-2-one,18402-84-1," The acute oral, dermal and inhalation toxicity of the target substance (3E)-dec-3-en-2-one was assessed in three in vivo studies conducted according to OECD test guideline 425, 402 and 403, respectively. Based on the results of the acute oral and dermal toxicity studies no classification is warranted for acute oral and dermal toxicity. Whereas, based on the results from the OECD 403 acute inhalation study, classifcation as Acute Tox. 4 (H332) is warranted in accordance with CLP Regulation 1272/2008. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c72f325-d195-4769-a098-31823aeab8bd/documents/1e86461d-75c8-4687-b3ee-1655f3850d52_b50272d0-91cb-4370-b631-6384216bbb71.html,,,,,, (3E)-dec-3-en-2-one,18402-84-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c72f325-d195-4769-a098-31823aeab8bd/documents/1e86461d-75c8-4687-b3ee-1655f3850d52_b50272d0-91cb-4370-b631-6384216bbb71.html,,inhalation,LC50,0.52 mg/m3,adverse effect observed, (3-fluoro-4'-propyl[biphenyl]-4-yl)boronic acid,909709-42-8," This study was performed with a structural analogue substance according to GLP and is fully compliant OECD TG 423. Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg after single oral administration in rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7045e9a-1f0d-435e-84d6-0575ed5e63cc/documents/16bd90d7-09f2-42b8-96f7-7b86d720480a_bf12f642-4bd5-4d50-882c-4f0bdb994741.html,,,,,, (3-fluoro-4'-propyl[biphenyl]-4-yl)boronic acid,909709-42-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7045e9a-1f0d-435e-84d6-0575ed5e63cc/documents/16bd90d7-09f2-42b8-96f7-7b86d720480a_bf12f642-4bd5-4d50-882c-4f0bdb994741.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "(3R)-3,7-dimethyloct-6-enenitrile",35931-93-2," This endpoint was fulfilled using read across from 3,7-dimethyloct-6-enenitrile (EC 257-288-8 / CAS 51566-62-2), for which the following results were obtained. 90 -Day Repeated Dose Study: Repeated dose toxicity was assessed according to test guideline OECD 408. The oral administration of the test substance to rats for a period of ninety consecutive days at dose levels of 10, 30, 100 and 300 mgkglday resulted in treatment-related effects in animals of either sex treated with 300 and 100 mg/kg/day. No such changes were demonstrated at 30 or 10 mgkglday. The 'No Observed Effect Level' (NOEL) was, therefore considered to be 30 mg/kg/day. 300 mgkglday may be regarded as a ""No Observed Adverse Effect Level"" (NOAEL). One-generation reproduction toxicity study: A One-generation reproduction toxicity study, based on OECD test guideline 415 was also used to assess repeated dose toxicity. Based on the results of this study, where animals were treated at doses 75, 200 and 500 mg/kg/day, the no-observable-adverse-effect-level (NOAEL) for toxicity of the test substance is 200 mg/kg/day. Increased incidences of excess salivation and/or ungroomed coat occurred in P generation male and/or female rats in the 500 mg/kg/day dosage group. However, these clinical signs were not considered an adverse effect of the test item. At 500 mg/kg/day, sporadic reductions in body weight gains occurred in male rats prior to cohabitation, followed by persistent reductions in weight gain through the end of the study. Non-reproductive organ weights were affected in both sexes at the end of the dosage period, as well as terminal body weights. Increased brain and spleen weights occurred in male rats treated with 500 mg/kg/day test item, while increased liver and kidney weights occurred in both sexes in this same dosage group. The toxicological significance of the increased organ weights was unable to be determined because there were no microscopic findings that could be correlated with the changes in organ weights. The OECD 415 was not tested at 300 mg/kg and because 500 mg/kg was found to have an adverse effect, by default 200 mg/kg became the NOAEL (because it is the next highest dose level). The substance was not tested at 300 mg/kg in the OECD 415 study, and so it cannot refute the findings of the 90 day study. Therefore the overall NOAEL is considered to be 300 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d50a0e2-b207-4b71-8aa8-a3238d639ff2/documents/ea294a3b-b0d9-454b-83fe-e3cb39f6e15c_967ac0b0-9721-433d-b471-5fb86018216d.html,,,,,, "(3R)-3,7-dimethyloct-6-enenitrile",35931-93-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d50a0e2-b207-4b71-8aa8-a3238d639ff2/documents/ea294a3b-b0d9-454b-83fe-e3cb39f6e15c_967ac0b0-9721-433d-b471-5fb86018216d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "(3R)-3,7-dimethyloct-6-enenitrile",35931-93-2," These endpoints were fulfilled using read across from 3,7-dimethyloct-6-enenitrile (EC 257-288-8 / CAS 51566-62-2), for which the following results were obtained. Acute toxicity: Oral : Tested doses: 3.15, 3.96, 4.46, 6.30 and 7.94 g/kg LD50 = 4.49 (3.74 - 5.39) g/kg Acute toxicity: Inhalation: The acute toxicity via the inhalation route was assessed using test guideline equivalent or similar to OECD 403. LC50: >4.9 mg/L on male / females. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d50a0e2-b207-4b71-8aa8-a3238d639ff2/documents/cf7439db-312b-4467-a69b-bff98ec75cf3_967ac0b0-9721-433d-b471-5fb86018216d.html,,,,,, "(3R)-3,7-dimethyloct-6-enenitrile",35931-93-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d50a0e2-b207-4b71-8aa8-a3238d639ff2/documents/cf7439db-312b-4467-a69b-bff98ec75cf3_967ac0b0-9721-433d-b471-5fb86018216d.html,,oral,LD50,"4,490 mg/kg bw",adverse effect observed, "(3R)-3,7-dimethyloct-6-enenitrile",35931-93-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d50a0e2-b207-4b71-8aa8-a3238d639ff2/documents/cf7439db-312b-4467-a69b-bff98ec75cf3_967ac0b0-9721-433d-b471-5fb86018216d.html,,inhalation,LC50,"4,900 mg/m3",no adverse effect observed, "(3R,3aR,6S,6aR)-Hexahydrofuro[3,2-b]furan-3,6-diyl bis(4-hydroxybenzoate)",185756-31-4, The oral LD50 for rats was determined to be >2000 mg/kg bw. No mortality was observed. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4c0d865-8477-4c6f-984f-28972ab747d3/documents/04ce6ecc-8c0a-4282-80de-d0ee9e09cc24_1a1184ad-44b3-4853-b16e-1163015959a8.html,,,,,, "(3R,3aR,6S,6aR)-Hexahydrofuro[3,2-b]furan-3,6-diyl bis(4-hydroxybenzoate)",185756-31-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4c0d865-8477-4c6f-984f-28972ab747d3/documents/04ce6ecc-8c0a-4282-80de-d0ee9e09cc24_1a1184ad-44b3-4853-b16e-1163015959a8.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "(3R,3AS,6AR)-HEXAHYDROFURO[2,3-B]FURAN-3-OL",156928-09-5," Repeated dose toxicity - oral: A key K1 study in male and female Wistar rats in a 28 days repeated dose test was conducted according to OECD 407 (Brunke et al., 2007). No NOEL or NOAEL could be established based on the results of the study. The LOAEL in this study was derived to be 15 mg/kg bw/d for both males and females, based on the finding of elevated bilirubin (males and females) correlated with slightly elevated hemopoiesis in liver and/or spleen (males and female), changes in red blood cell count (males and females), and increased liver weights in males. It should be noted that in the OECD 421, no treatment related effects were observed at the same dose. Therefore, this LOAEL should be considered as a worst-case scenario.   Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbb5ccda-2424-44bc-a572-672acdad1bcb/documents/IUC5-31df0c63-46bc-45f9-a20f-cd7a5c38abba_ad9bfd4f-af8f-4b6d-8665-4bd2114dee3a.html,,,,,, "(3R,3AS,6AR)-HEXAHYDROFURO[2,3-B]FURAN-3-OL",156928-09-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbb5ccda-2424-44bc-a572-672acdad1bcb/documents/IUC5-31df0c63-46bc-45f9-a20f-cd7a5c38abba_ad9bfd4f-af8f-4b6d-8665-4bd2114dee3a.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,15 mg/kg bw/day,,rat "(3R,3AS,6AR)-HEXAHYDROFURO[2,3-B]FURAN-3-OL",156928-09-5,"Acute oral toxicity: In an acute oral toxicity GLP-study in HanRcc:Wist (SPF) rats, following the acute toxic class method in accordance with the OECD guideline n°423 and EU Method B.1 tris, the LD50 was determined to be in the range 300-2000 mg/kg for both females and males (K1, Esposito, 2007)Acute toxicity via inhalation: No reliable data were available. However, this endpoint is waived as specific data are available for the oral and dermal exposure route.Acute dermal toxicity: A K1 acute dermal test was performed in male and female HanRcc:WIST (SPF) rats according to OECD Guideline 402 and EC method B3 without deviations. The median lethal dose of the substance after 24-h dermal exposure to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg body weight (K1, Esposito, 2007) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbb5ccda-2424-44bc-a572-672acdad1bcb/documents/IUC5-3f83f70f-c954-4191-8975-9b542edd40d1_ad9bfd4f-af8f-4b6d-8665-4bd2114dee3a.html,,,,,, "(3R,3AS,6AR)-HEXAHYDROFURO[2,3-B]FURAN-3-OL",156928-09-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbb5ccda-2424-44bc-a572-672acdad1bcb/documents/IUC5-3f83f70f-c954-4191-8975-9b542edd40d1_ad9bfd4f-af8f-4b6d-8665-4bd2114dee3a.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "(3R,3AS,6AR)-HEXAHYDROFURO[2,3-B]FURAN-3-OL",156928-09-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbb5ccda-2424-44bc-a572-672acdad1bcb/documents/IUC5-3f83f70f-c954-4191-8975-9b542edd40d1_ad9bfd4f-af8f-4b6d-8665-4bd2114dee3a.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "(3R,5Z)-3-METHYL-5-CYCLOPENTADECEN-1-ONE",464207-51-0," Acute toxicity: oral: LD50 > 2000 mg/kg bw (read-across, OECD 401, GLP, K, rel. 1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcde8908-f6b4-46e0-a258-9c5ee2f8492f/documents/IUC5-3c832d09-9f99-49c2-a6e7-3e2cc963e9b0_ae181c91-01c1-4a30-b006-c963f1b3ee8d.html,,,,,, "(3R,5Z)-3-METHYL-5-CYCLOPENTADECEN-1-ONE",464207-51-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcde8908-f6b4-46e0-a258-9c5ee2f8492f/documents/IUC5-3c832d09-9f99-49c2-a6e7-3e2cc963e9b0_ae181c91-01c1-4a30-b006-c963f1b3ee8d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(3S,4aS,8aS)-N-tert-Butyldecahydro-3-isoquinolinecarboxamide",136465-81-1,"A NOEL of 150 mg/kg bw/d is identified in a 28-day rat study based on mortality, signs of toxicity, changes in haematological and clinical chemistry parameters and liver pathology at the highest dose level of 600 mg/kg bw/d. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/747618f6-9d00-4b0a-91f6-9d91625cc17c/documents/IUC5-5e0c4162-a022-4b02-ac6c-5e5d52816094_3ff90b81-8e02-4c7c-b797-45f73545041d.html,,,,,, "(3S,4aS,8aS)-N-tert-Butyldecahydro-3-isoquinolinecarboxamide",136465-81-1,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/747618f6-9d00-4b0a-91f6-9d91625cc17c/documents/IUC5-5e0c4162-a022-4b02-ac6c-5e5d52816094_3ff90b81-8e02-4c7c-b797-45f73545041d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "(3S,4aS,8aS)-N-tert-Butyldecahydro-3-isoquinolinecarboxamide",136465-81-1,"An acute oral toxicity assessment was conducted to determine the maximum non-lethal dose of PTH-decahydroamide in rats. Following administration of 200, 1000 and 2000 mg/kg bw doses, deaths occurred at the two higher levels and the maximum non-lethal dose was confirmed to be between 200 and 1000 mg/kg bw. The median lethal oral dose was estimated to exceed the limit dose of 2000 mg/kg bw BUT THIS CANNOT BE CONFIRMED FROM THE STUDY SUMMARY SINCE NO INDICATION OF ANIMAL NUMBERS IS CURRENTLY AVAILABLE.In an acute dermal toxicity study, five male and five female rats were exposed for 24 hours to a dose of 2000 mg/kg bw PTH-dechydroamide dispersed in 1% aqueous CMC. Two males died shortly after completion of exposure but the remaining animals showed no clear signs of reaction to treatment at the limit dose and th median lethal dose was confirmed to exceed 2000 mg/kg bw. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/747618f6-9d00-4b0a-91f6-9d91625cc17c/documents/IUC5-548f6652-c5f9-412c-af6d-149e939f5e7a_3ff90b81-8e02-4c7c-b797-45f73545041d.html,,,,,, "(3S,4aS,8aS)-N-tert-Butyldecahydro-3-isoquinolinecarboxamide",136465-81-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/747618f6-9d00-4b0a-91f6-9d91625cc17c/documents/IUC5-548f6652-c5f9-412c-af6d-149e939f5e7a_3ff90b81-8e02-4c7c-b797-45f73545041d.html,,oral,LD50,"2,000 mg/kg bw",, "(3S,4aS,8aS)-N-tert-Butyldecahydro-3-isoquinolinecarboxamide",136465-81-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/747618f6-9d00-4b0a-91f6-9d91625cc17c/documents/IUC5-548f6652-c5f9-412c-af6d-149e939f5e7a_3ff90b81-8e02-4c7c-b797-45f73545041d.html,,dermal,LD50,"2,000 mg/kg bw",, "(3S-cis)-3,6-dimethyl-1,4-dioxane-2,5-dione",4511-42-6," Lactide (18:1 mixture of L-lactide and m-lactide) was tested in dogs in a 2-week dose range finding study and a subsequent 90d full study (similar to OECD 409). The primary toxic effect was irritation of the gastrointestinal tract at 100 mg/kg/d in the 90d study. In addition, in an oral subchronic repeated dose toxicity study conducted with a suitable read-across partner, calcium lactate was used to assess the specific target organ toxicity of the target substance. Based on the results, no classification for specific target organ toxicity is warranted for L-lactide. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4226a28-b017-4858-b6b1-18111b841e52/documents/IUC5-f49f44cb-e6e5-4c94-8568-7261cbbc8e6c_f78d226f-fafc-4a7f-8a42-036c471c1c73.html,,,,,, "(3S-cis)-3,6-dimethyl-1,4-dioxane-2,5-dione",4511-42-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4226a28-b017-4858-b6b1-18111b841e52/documents/IUC5-f49f44cb-e6e5-4c94-8568-7261cbbc8e6c_f78d226f-fafc-4a7f-8a42-036c471c1c73.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,dog "(3S-cis)-3,6-dimethyl-1,4-dioxane-2,5-dione",4511-42-6,"A sample of L-lactide was examined for acute oral toxicity in an experiment according to OECD guideline 423 with male and female rats (limit testing). A dose level of 2000 mg/kg body weight was examined. No mortality or distinct clinical signs were observed after treatment of 3 males and 3 females with the 2000 mg/kg dose level.In an acute dermal toxicity study (limit test), a group of young adult Wistar rats (5 males and 5 females) was dermally exposed to L-lactide (purity 99%) in polyethylene glycol 400 for 24 hours to approximately 10% of body surface area at 2000 mg/kg bw. Animals were observed for 14 days. No mortality occurred. There were no treatment related clinical signs, necropsy findings or changes in body weight.Lactic acid is used as a read-across partner for L-lactide and in an acute inhalation toxicity study in rats with lactic acid a LC50 of > 7.94 mg/L air was determined. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4226a28-b017-4858-b6b1-18111b841e52/documents/IUC5-a3d410ce-f5a5-4ac0-9feb-dddb34f3b2b8_f78d226f-fafc-4a7f-8a42-036c471c1c73.html,,,,,, "(3S-cis)-3,6-dimethyl-1,4-dioxane-2,5-dione",4511-42-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4226a28-b017-4858-b6b1-18111b841e52/documents/IUC5-a3d410ce-f5a5-4ac0-9feb-dddb34f3b2b8_f78d226f-fafc-4a7f-8a42-036c471c1c73.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(3S-cis)-3,6-dimethyl-1,4-dioxane-2,5-dione",4511-42-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4226a28-b017-4858-b6b1-18111b841e52/documents/IUC5-a3d410ce-f5a5-4ac0-9feb-dddb34f3b2b8_f78d226f-fafc-4a7f-8a42-036c471c1c73.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(3S-cis)-3,6-dimethyl-1,4-dioxane-2,5-dione",4511-42-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4226a28-b017-4858-b6b1-18111b841e52/documents/IUC5-a3d410ce-f5a5-4ac0-9feb-dddb34f3b2b8_f78d226f-fafc-4a7f-8a42-036c471c1c73.html,,inhalation,LC50,"7,940 mg/m3",adverse effect observed, (3Z)-hex-3-en-1-yl 2-methylprop-2-en-1-yl ether,292605-05-1,"The acute oral toxicity of the test substance Vivaldie was evaluated in rats according to OECD (No. 401, 24th February 1 987) and EC (92/69/EEC, B. l , 31st July 1992) guidelines. The test substance was administered by oral route (gavage) to one group of ten fasted SpragueDawley rats (five males and five females). The test substance was administered undiluted at the dose of 2000 mg/kg, taking into consideration that its specific gravity was 0.8180 g/ml. No deaths were observed during the study. Sedation and piloerection were observed in 4/5 males and 5/5 females, on day 1 only. Recovery was complete on day 2. No other clinical signs were noted during the study. The overall body weight gain of the animals was not affected by treatment with the test substance. No apparent abnormalities were observed at necropsy in any animal. Under the experimental conditions of this study, the oral LD50 of the test substance Vivaldie is higher than 2000 mg/kg in rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c06c3cc-c408-49a5-8492-54089c031a2d/documents/IUC5-92ada918-91e4-46e6-a70f-f2c1d82b899a_2998cfb2-6b9e-4401-a63c-7248f6f7f380.html,,,,,, (3Z)-hex-3-en-1-yl 2-methylprop-2-en-1-yl ether,292605-05-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c06c3cc-c408-49a5-8492-54089c031a2d/documents/IUC5-92ada918-91e4-46e6-a70f-f2c1d82b899a_2998cfb2-6b9e-4401-a63c-7248f6f7f380.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, (4-amino-1-hydroxy-1-phosphonobutyl)phosphonic acid;hydrate,138624-11-0," A LOAEL of 0.411 mg/kg bw/day was derived from chronic studies in rat and dog, based upon effects on retention in the primary spongiosa of the bones examined (ribs and femurs) at all doses tested. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/581fd7cd-e80e-4b84-b018-840f3b680a45/documents/a1235fa2-8622-455c-8803-3d331250a575_188cdda9-3bae-4cf0-988c-c5f25f5a7ecf.html,,,,,, (4-amino-1-hydroxy-1-phosphonobutyl)phosphonic acid;hydrate,138624-11-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/581fd7cd-e80e-4b84-b018-840f3b680a45/documents/a1235fa2-8622-455c-8803-3d331250a575_188cdda9-3bae-4cf0-988c-c5f25f5a7ecf.html,Chronic toxicity – systemic effects,oral,LOAEL,0.411 mg/kg bw/day,,dog "(4E)-4-(3,3,4-trimethylcyclopentylidene)butanal",2411191-47-2,"Acute toxicity: oral: 300 mg/kg bw < LD50 < 2000 mg/kg bw (OECD 420, GLP, K, rel. 1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The key study is GLP-compliant and of high quality (Klimisch score = 1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d995401-d040-4f00-9477-5fbf783bac91/documents/4cc7a6f5-91f1-4b06-b3d0-b078d70e8ddf_c4fb372a-bc3c-4f31-a17d-fead758902ef.html,,,,,, "(4E)-4-(3,3,4-trimethylcyclopentylidene)butanal",2411191-47-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d995401-d040-4f00-9477-5fbf783bac91/documents/4cc7a6f5-91f1-4b06-b3d0-b078d70e8ddf_c4fb372a-bc3c-4f31-a17d-fead758902ef.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, (4E)-4-METHYL-5-(4-METHYLPHENYL)-4-PENTENAL,1226911-69-8," Repeated dose toxicity oral NOAEL (combined) = 300 mg/kg bw/day (OECD 407, GLP, K, Rel.1) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfe82827-7c54-46c3-b27d-69ad9174638b/documents/2a1635bb-deeb-4bbb-8e57-f6483ae1d21e_4c753985-257b-481a-a1d4-cd6160b9a565.html,,,,,, (4E)-4-METHYL-5-(4-METHYLPHENYL)-4-PENTENAL,1226911-69-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfe82827-7c54-46c3-b27d-69ad9174638b/documents/2a1635bb-deeb-4bbb-8e57-f6483ae1d21e_4c753985-257b-481a-a1d4-cd6160b9a565.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat (4E)-4-METHYL-5-(4-METHYLPHENYL)-4-PENTENAL,1226911-69-8," Oral LD50 (females) > 2000 mg/kg bw (OECD 420, K, Rel.1, fixed dose method in rats) Dermal LD50 (combined) > 2000 mg/kg bw (OECD 402, K, Rel.1, limit test in rats) Inhalation LC50 (combined) > 5.31 mg/L (= 5310 mg/m3) (OECD 436, K, Rel.1, limit test/nose only in rats) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfe82827-7c54-46c3-b27d-69ad9174638b/documents/21cc0280-76e5-4c91-9d85-53151c170ea3_4c753985-257b-481a-a1d4-cd6160b9a565.html,,,,,, (4E)-4-METHYL-5-(4-METHYLPHENYL)-4-PENTENAL,1226911-69-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfe82827-7c54-46c3-b27d-69ad9174638b/documents/21cc0280-76e5-4c91-9d85-53151c170ea3_4c753985-257b-481a-a1d4-cd6160b9a565.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, (4E)-4-METHYL-5-(4-METHYLPHENYL)-4-PENTENAL,1226911-69-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfe82827-7c54-46c3-b27d-69ad9174638b/documents/21cc0280-76e5-4c91-9d85-53151c170ea3_4c753985-257b-481a-a1d4-cd6160b9a565.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, (4E)-4-METHYL-5-(4-METHYLPHENYL)-4-PENTENAL,1226911-69-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfe82827-7c54-46c3-b27d-69ad9174638b/documents/21cc0280-76e5-4c91-9d85-53151c170ea3_4c753985-257b-481a-a1d4-cd6160b9a565.html,,inhalation,LC50,"5,310 mg/m3",no adverse effect observed, "(4E)-5-cyclohexyl-2,4-dimethylpent-4-enal",1449104-34-0," Oral: LD50 > 2000 mg/kg bw and the LD50 cut-off estimated to be > 5000 mg/kg bw, female rat, OECD TG 420, 2018 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6cd101b2-ed31-40e5-942e-1732d6cdf9ae/documents/32249139-d75d-4630-b007-366d87488cea_4a3cdc60-edab-4e09-b2ae-0f33d20cd9f3.html,,,,,, "(4E)-5-cyclohexyl-2,4-dimethylpent-4-enal",1449104-34-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6cd101b2-ed31-40e5-942e-1732d6cdf9ae/documents/32249139-d75d-4630-b007-366d87488cea_4a3cdc60-edab-4e09-b2ae-0f33d20cd9f3.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, (4-nonylphenoxy)acetic acid,3115-49-9,"A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422) revealed parental toxicity at 200 mg/kg bw (slightly reduced body weight gains, increased Liver and thyroid gland weights, slightly increased kidney weights in males, macroscopic and histopathological changes in the stomach, minimal to slight diffuse follicular hypertrophy in the thyroid of females and increased T4 levels in both sexes). The NOAEL was considered to be 60 mg/kg body weight per day (WIL Research, 2013) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eec056ec-6ae7-4c91-a244-d8fd257ed4ce/documents/IUC5-deddb436-24ca-4f1d-9a7e-15dd8bfc477c_92fcb243-c844-4efc-8c32-55debfab527d.html,,,,,, (4-nonylphenoxy)acetic acid,3115-49-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eec056ec-6ae7-4c91-a244-d8fd257ed4ce/documents/IUC5-deddb436-24ca-4f1d-9a7e-15dd8bfc477c_92fcb243-c844-4efc-8c32-55debfab527d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,, (4-nonylphenoxy)acetic acid,3115-49-9,The substance is moderately toxic after single oral administration to rats (RCC 1986). The LD 50 was set at 1674 mg/kg for both sexes. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eec056ec-6ae7-4c91-a244-d8fd257ed4ce/documents/IUC5-8e4a606b-c49e-48ef-97de-c59962205c53_92fcb243-c844-4efc-8c32-55debfab527d.html,,,,,, (4-nonylphenoxy)acetic acid,3115-49-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eec056ec-6ae7-4c91-a244-d8fd257ed4ce/documents/IUC5-8e4a606b-c49e-48ef-97de-c59962205c53_92fcb243-c844-4efc-8c32-55debfab527d.html,,oral,LD50,"1,674 mg/kg bw",adverse effect observed, "(4R,6R)-4-Hydroxy-2,2,6-trimethylcyclohexanone / 60046-50-6",60046-50-6,"Only the acute toxicity (oral) was carried out. A test for the acute toxicity of the testing substance Actinol was carried out in three female and three male HanIbm: WIST (SPF) rats according to OECD Guideline for the Testing of Chemicals No. 423 and Directive 96/54/EEC, Annex B.1 tris. The testing animals received one single dose of Actionl by oral gavage. The test article was suspended in vehicle (bi-distilled water) at a concentration of 0.2 g/mL and administered at a volume of 10 mL/kg. The animals were examined for clinical signs five times during day 1 and once daily during days 2 -15. Mortality/viability were recorded together with clinical signs at the same time intervals. Bodyweights were recorded on day 1 prior to administration and on days 8 and 15. All animals were necropsied and examined macroscopically.No death occurred during the study.Several clinical signs like sedation, ventral position and ruffled fur were observed on test day 1 in males and females. All clinical signs were reversible on test day 5.The bodyweight of the animals was within the range commonly recorded for this strain and age.No macrocopic findings were observed at necropsy.The median lethal dose of Actinol after a single oral dose to rats of both sexes, observed over a period of 14 days, could not be estimated as no death occurred.LD50 rat: greater than 2000 mg/kg bodyweigth. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a2ea3b0-4210-4dfb-b30d-7c9f4a58cfd7/documents/IUC5-95281484-f7a8-4952-85c6-e1dd018684dc_3b88ee09-8695-422d-9892-bbb6dd8d78d6.html,,,,,, "(4R,6R)-4-Hydroxy-2,2,6-trimethylcyclohexanone / 60046-50-6",60046-50-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a2ea3b0-4210-4dfb-b30d-7c9f4a58cfd7/documents/IUC5-95281484-f7a8-4952-85c6-e1dd018684dc_3b88ee09-8695-422d-9892-bbb6dd8d78d6.html,,oral,LD50,"2,000 mg/kg bw",, "(4-tert-butyl-2,6-dimethylphenyl)acetonitrile",84803-57-6,"An oral LD50 of >2000 mg/kg was determined in an acute oral toxicity study (OECD 423, GLP). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86b43747-a293-49cf-97bf-8f282a28a132/documents/IUC5-9deed655-c6b8-4f7e-ac04-f1aa41e8b837_79ac0c3c-849f-4c90-aaaa-f3bcf3bf4f68.html,,,,,, "(5,6-Dimethyl-9-oxo-9H-xanthen-4-yl)acetic acid",117570-53-3,MTD oral: 1000 mg/kgSpecies: ratValue from salt form ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5e05205-e9bc-4d9a-aa43-780728e57c89/documents/IUC5-ab4a970f-1bb1-43f3-b901-97a78aa67633_b60820e9-9cc3-45bb-87e5-a0abfaea5e64.html,,,,,, "(5E)-3,5-dimethyloct-5-en-4-ol",2209852-19-5," Oral (dietary): NOAEL (rat): Male: 2500 ppm (equivalent to ≥ 146 mg/kg bw/day), and/or Female: 12000 ppm (equivalent to ≥ 806 mg/kg bw/day male/female), OECD TG 422, 2019 The observed hyaline droplet accumulation due to alpha-2u-globulin, is both sex and species specific and is not generally considered to be significant in man. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7c73b50-f1bb-4abe-8505-ec05232d852c/documents/54582eed-328b-432a-a0db-2b5bb351990f_72f51045-898b-4157-abc0-0b70a9bb60aa.html,,,,,, "(5E)-3,5-dimethyloct-5-en-4-ol",2209852-19-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7c73b50-f1bb-4abe-8505-ec05232d852c/documents/54582eed-328b-432a-a0db-2b5bb351990f_72f51045-898b-4157-abc0-0b70a9bb60aa.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,146 mg/kg bw/day,,rat "(5E)-3,5-dimethyloct-5-en-4-ol",2209852-19-5," Oral: LD50 > 300 - < 2000 mg/kg bw, female rat, OECD TG 420, 2018 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7c73b50-f1bb-4abe-8505-ec05232d852c/documents/5ef440b5-d640-42e9-8c99-56824384c232_72f51045-898b-4157-abc0-0b70a9bb60aa.html,,,,,, "(5E)-3,5-dimethyloct-5-en-4-ol",2209852-19-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7c73b50-f1bb-4abe-8505-ec05232d852c/documents/5ef440b5-d640-42e9-8c99-56824384c232_72f51045-898b-4157-abc0-0b70a9bb60aa.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, (5or8)-aminonaphthalene-2-sulphonic acid,51548-48-2,Estimated LD50 was considered to be 8645.7 mg/kg bw when rats were treated with (5or8)-aminonaphthalene-2-sulphonic acid orally.   ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1762ae54-e441-4c22-81d4-2ee19ad205a1/documents/IUC5-3136ea1f-e0a6-4518-86bf-d9ea170d4c8d_c8fd5097-85d3-43b4-bf22-00da24e14e53.html,,,,,, (5or8)-aminonaphthalene-2-sulphonic acid,51548-48-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1762ae54-e441-4c22-81d4-2ee19ad205a1/documents/IUC5-3136ea1f-e0a6-4518-86bf-d9ea170d4c8d_c8fd5097-85d3-43b4-bf22-00da24e14e53.html,,oral,LD50,"8,645.7 mg/kg bw",no adverse effect observed, (6-amino-2-pyridyl)-(1-methyl-4-piperidyl)methanone;dihydrate;dihydrochloride,2356133-42-9," Two studies carried out. The first used dose levels of 300mg/kg and 2000mg/kg. Results show that the LD50 lies between the two dose levels. A second study was carried out using a dose level of 450mg/kg. Under the conditions of this test, the LD50 of this substance is estimated to be 450mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d623c125-017c-4580-84a4-ca6354df9aa5/documents/a327155f-d9ec-440e-a90f-1c89c53d6fb0_1697dce1-4f42-4b92-adf6-2f001d9483c4.html,,,,,, (6-amino-2-pyridyl)-(1-methyl-4-piperidyl)methanone;dihydrate;dihydrochloride,2356133-42-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d623c125-017c-4580-84a4-ca6354df9aa5/documents/a327155f-d9ec-440e-a90f-1c89c53d6fb0_1697dce1-4f42-4b92-adf6-2f001d9483c4.html,,oral,LD50,450 mg/kg bw,adverse effect observed, (6-aminohexyl)carbamic acid,143-06-6, Repeat Dose Oral Toxicity: NOAEL = 50 mg/Kg bw/day (Rat) Repeat Dose Inhalation Toxicity: waiving Repeat Dose Dermal Toxicity: waiving ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0fbb44b-aee8-4d49-937e-f8a161f2cea5/documents/961e7401-4054-4402-ba17-fd138b257ed9_9d147f9a-9f13-447a-8a49-59776a68dd05.html,,,,,, (6-aminohexyl)carbamic acid,143-06-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0fbb44b-aee8-4d49-937e-f8a161f2cea5/documents/961e7401-4054-4402-ba17-fd138b257ed9_9d147f9a-9f13-447a-8a49-59776a68dd05.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat (6-aminohexyl)carbamic acid,143-06-6, Acute oral LD50: 2875 mg/Kg (95% C.I: 2614 – 3162 mg/Kg). Acute Dermal LD50: >2000 mg/Kg. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0fbb44b-aee8-4d49-937e-f8a161f2cea5/documents/5b05625f-793c-4344-b26c-41d217a61f8f_9d147f9a-9f13-447a-8a49-59776a68dd05.html,,,,,, (6-aminohexyl)carbamic acid,143-06-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0fbb44b-aee8-4d49-937e-f8a161f2cea5/documents/5b05625f-793c-4344-b26c-41d217a61f8f_9d147f9a-9f13-447a-8a49-59776a68dd05.html,,oral,LD50,"2,875 mg/kg bw",adverse effect observed, "(6R,7R)-7-[[(2Z)-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-[(triphenylmethoxy)imino]acethyl]amino]-3-(hydroxymethyl)-8-oxo-5thia-1-azabicyclo[4.2.0]oct-2-ene-carboxylic acid diphenylmethyl ester",376653-36-0, Acute toxicity: oral LD50 > 2000 mg/kg bw in female CRL:(WI) rats.   ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04a20dfa-758c-4e59-ad2e-9dc15dd71a25/documents/e9c7741a-06e5-464d-810d-75a98ac2fe5d_4b4d5d2b-78ca-4318-9a6a-e605ea8d45d8.html,,,,,, "(6R,7R)-7-[[(2Z)-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-[(triphenylmethoxy)imino]acethyl]amino]-3-(hydroxymethyl)-8-oxo-5thia-1-azabicyclo[4.2.0]oct-2-ene-carboxylic acid diphenylmethyl ester",376653-36-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04a20dfa-758c-4e59-ad2e-9dc15dd71a25/documents/e9c7741a-06e5-464d-810d-75a98ac2fe5d_4b4d5d2b-78ca-4318-9a6a-e605ea8d45d8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(6R,7R)-7-amino-3-{[(furan-2-ylcarbonyl)sulfanyl]methyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid",80370-59-8, The substance has a low acute toxicity to rats when applied orally LD50oral > 2000 mg/kg bw ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ba5b0ea-ac6d-4774-a051-ea47bd1809a2/documents/1054fbbb-8368-4fe7-8ae2-fc34a31498cb_9a1a6734-9093-4476-9da8-27b819d51661.html,,,,,, "(6R,7R)-7-amino-3-{[(furan-2-ylcarbonyl)sulfanyl]methyl}-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid",80370-59-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ba5b0ea-ac6d-4774-a051-ea47bd1809a2/documents/1054fbbb-8368-4fe7-8ae2-fc34a31498cb_9a1a6734-9093-4476-9da8-27b819d51661.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, (6R-trans)-7-amino-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid,22252-43-3," Subacute toxicity of 7-aminodesacetoxycephalosporanic acid was tested in three studies with Wistar rats, during 7 and 28 days. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/daa7759f-e5bb-4afe-ad87-819cdc6f43b1/documents/e1adc8f3-648f-4846-9932-2541f550718b_19db93aa-c885-4fbb-acdf-1a0e45529955.html,,,,,, (6R-trans)-7-amino-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid,22252-43-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/daa7759f-e5bb-4afe-ad87-819cdc6f43b1/documents/e1adc8f3-648f-4846-9932-2541f550718b_19db93aa-c885-4fbb-acdf-1a0e45529955.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"2,700 mg/kg bw/day",,rat (7R)-7-(4-carboxybutanamido)cephalosporanate amidohydrolase (enzyme substance),56645-46-6,"LD50 (oral,rat) > 2000 mg/kg (RA from the source substance aldolase, OECD 423, GLP) ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d611683-d29b-40ff-8e9d-71c6b2aec8c5/documents/2e6dcb84-e240-4188-958b-3cdeaee00e15_acf938d8-cd49-4b54-8622-e530006d034f.html,,,,,, "(7S,9aS)-7-[(benzyloxy)methyl]octahydropyrazino[2,1-c][1,4]oxazine dioxalic acid salt",1268364-46-0,"Oral (gavage) administration of test item to male and female rats for 4 weeks at dose levels of 50, 150, or 300 mg/kg/day was well tolerated with no mortality and for males only, a reduction in body weight gain during the initial week of dosing at ≥ 150 mg/kg/day with an associated reduction in food consumption at 300 mg/kg/day. A transient reduction in activity was seen in the motor activity assessment, as expressed by a reduction in basic movements, fine movements, and XY ambulation reductions at 300 mg/kg/day and rearing activity at ≥ 150 mg/kg/day. Increases in liver weights were seen for females at 300 mg/kg/day only and correlated with centrilobular hepatocellular hypertrophy. Prostate/seminal vesicle (300 mg/kg/day) and spleen (≥ 150 mg/kg/day) weights were increased for males but without microscopic correlates. Due to the mild severity of findings and the lack of impact on the health and wellbeing of animals administered 300 mg/kg/day, effects for this dose were considered non-adverse. Thus, the no observed adverse effect level (NOAEL) is 300 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b70fcea4-7cc0-4132-bfa4-333e7161b46f/documents/8b3cfe20-c305-495c-8256-b61f405bde3b_02c415a1-aa0e-49a9-a16f-4911bb2a48eb.html,,,,,, "(7S,9aS)-7-[(benzyloxy)methyl]octahydropyrazino[2,1-c][1,4]oxazine dioxalic acid salt",1268364-46-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b70fcea4-7cc0-4132-bfa4-333e7161b46f/documents/8b3cfe20-c305-495c-8256-b61f405bde3b_02c415a1-aa0e-49a9-a16f-4911bb2a48eb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "(7S,9aS)-7-[(benzyloxy)methyl]octahydropyrazino[2,1-c][1,4]oxazine dioxalic acid salt",1268364-46-0,"Acute toxicity: oral (rats, OECD TG 420): LD50: 300 mg/kg < LD 50 ≤ 2000 mg/kg bw The acute toxicity of the test material was assessed in a study conducted to OECD 420. Females were administered 300 or 2000 mg/kg Morpholino-Piperazine Dioxalate orally (via gavage) on a single occasion and observed for 15 days. At 2000 mg/kg/day, the dose sighting animal was sacrificed in a moribund condition. At 300 mg/kg a single animal was euthanized in a moribund condition; there was no further mortality and no adverse clinical signs in remaining animals. Based on the data, Morpholino-Piperazine Dioxalate can be assigned Category 4 (300 mg/kg < LD50 ≤ 2000 mg/kg) in the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) for acute oral exposure.   Acute toxicity: dermal (rats, OECD TG 402): LD50: > 2000 mg/kg b.w. The study was performed to asses the acute dermal toxicity of the test item in female SD rats according to the OECD guideline 402.The single dermal administration of the test substance to the rats at a dose of 2000 mg/kg b.w. was tolerated without any mortality or compound-related clinical or macroscopic pathological signs.The LD50 acute dermal toxicity in female SD rats was estimated to be > 2000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b70fcea4-7cc0-4132-bfa4-333e7161b46f/documents/b46b25cb-ca5e-4992-87b2-cc1d40452166_02c415a1-aa0e-49a9-a16f-4911bb2a48eb.html,,,,,, "(7S,9aS)-7-[(benzyloxy)methyl]octahydropyrazino[2,1-c][1,4]oxazine dioxalic acid salt",1268364-46-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b70fcea4-7cc0-4132-bfa4-333e7161b46f/documents/b46b25cb-ca5e-4992-87b2-cc1d40452166_02c415a1-aa0e-49a9-a16f-4911bb2a48eb.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, "(7S,9aS)-7-[(benzyloxy)methyl]octahydropyrazino[2,1-c][1,4]oxazine dioxalic acid salt",1268364-46-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b70fcea4-7cc0-4132-bfa4-333e7161b46f/documents/b46b25cb-ca5e-4992-87b2-cc1d40452166_02c415a1-aa0e-49a9-a16f-4911bb2a48eb.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(8α,9R,8'''α,9'''R)-1,1'-[(2,3,5,6-tetrafluoro-1,4-phenylene)bis(methylene)]bis(6'-methoxycinchonan-1-ium-9-ol) dibromide",1879067-61-4,"28-day NOAEL = 1000 mg/kg bw/day, oral by gavage, 28 days, rats (Norman 2022) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3fb8f62-8ea6-4156-a8b0-0acffa4f41d5/documents/0e0e7c2e-1463-4b1b-b60e-3c564506be9e_ebb63ed3-baa8-431c-a154-7278b2d0cf07.html,,,,,, "(8α,9R,8'''α,9'''R)-1,1'-[(2,3,5,6-tetrafluoro-1,4-phenylene)bis(methylene)]bis(6'-methoxycinchonan-1-ium-9-ol) dibromide",1879067-61-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3fb8f62-8ea6-4156-a8b0-0acffa4f41d5/documents/0e0e7c2e-1463-4b1b-b60e-3c564506be9e_ebb63ed3-baa8-431c-a154-7278b2d0cf07.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "(8α,9R,8'''α,9'''R)-1,1'-[(2,3,5,6-tetrafluoro-1,4-phenylene)bis(methylene)]bis(6'-methoxycinchonan-1-ium-9-ol) dibromide",1879067-61-4,"Female rats: acute, oral LD50 >2000 mg/kg (GLP, OECD TG 425) Female and male rats: acute, inhalation LC50 >2.53 mg/L (GLP, OECD TG 403), 2.53 mg/L was the highest achievable concentration ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3fb8f62-8ea6-4156-a8b0-0acffa4f41d5/documents/86c9f28b-d62b-4de4-8039-f8e588873f3e_ebb63ed3-baa8-431c-a154-7278b2d0cf07.html,,,,,, "(8α,9R,8'''α,9'''R)-1,1'-[(2,3,5,6-tetrafluoro-1,4-phenylene)bis(methylene)]bis(6'-methoxycinchonan-1-ium-9-ol) dibromide",1879067-61-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3fb8f62-8ea6-4156-a8b0-0acffa4f41d5/documents/86c9f28b-d62b-4de4-8039-f8e588873f3e_ebb63ed3-baa8-431c-a154-7278b2d0cf07.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "(8α,9R,8'''α,9'''R)-1,1'-[(2,3,5,6-tetrafluoro-1,4-phenylene)bis(methylene)]bis(6'-methoxycinchonan-1-ium-9-ol) dibromide",1879067-61-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3fb8f62-8ea6-4156-a8b0-0acffa4f41d5/documents/86c9f28b-d62b-4de4-8039-f8e588873f3e_ebb63ed3-baa8-431c-a154-7278b2d0cf07.html,,inhalation,LC50,> 2.53 mg/L,adverse effect observed, "(benzoato-O,O')hydroxy(octadecanoato-O,O')aluminium",54326-11-3,"An oral repeated dose toxicity study in rats is available for the read across substance aluminum, benzoate C16-18-fatty acids complexes, incorporating reprotoxicity screening conducted according to OECD 422. No adverse effect was seen in any of the toxicological parameters examined at any dose. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/219a6083-926c-4280-8def-f2655218fea4/documents/IUC5-b29aec16-06dc-4872-917d-aabeda8ec22a_f573f29e-ee44-4915-ac26-3bdaf79f0a54.html,,,,,, "(benzoato-O,O')hydroxy(octadecanoato-O,O')aluminium",54326-11-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/219a6083-926c-4280-8def-f2655218fea4/documents/IUC5-b29aec16-06dc-4872-917d-aabeda8ec22a_f573f29e-ee44-4915-ac26-3bdaf79f0a54.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,225 mg/kg bw/day,,rat "(benzoato-O,O')hydroxy(octadecanoato-O,O')aluminium",54326-11-3,An acute oral toxicity study predicts an LD50 as >2000mg/kg bodyweight and an acute dermal toxicity study also predicts an LD50 as >2000 mg/kg bodyweight. There is no evidence of a relevant intrinsic acute oral or dermal toxicity requiring classification or substance specific Risk Management Measures. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/219a6083-926c-4280-8def-f2655218fea4/documents/IUC5-c93190b4-ec31-4c55-b3f6-d05fff5b22f1_f573f29e-ee44-4915-ac26-3bdaf79f0a54.html,,,,,, "(benzoato-O,O')hydroxy(octadecanoato-O,O')aluminium",54326-11-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/219a6083-926c-4280-8def-f2655218fea4/documents/IUC5-c93190b4-ec31-4c55-b3f6-d05fff5b22f1_f573f29e-ee44-4915-ac26-3bdaf79f0a54.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "(benzoato-O,O')hydroxy(octadecanoato-O,O')aluminium",54326-11-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/219a6083-926c-4280-8def-f2655218fea4/documents/IUC5-c93190b4-ec31-4c55-b3f6-d05fff5b22f1_f573f29e-ee44-4915-ac26-3bdaf79f0a54.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, (benzothiazol-2-ylthio)acetic acid,6295-57-4," A 14 day oral gavave dose-range finding study in Wistar rats was performed to assess the toxicity potential of the test item and to define the dose levels for subsequent toxicity studies. The test was performed at doses of 100, 300 and 1000 mg/kg bwt/day as solution in 0.5% NaCMC (w/v) in Milli-Q water. In the high dose group overt clinical signs, significant reduction in the body weight and food consumption were observed, followed by complete mortalities (during treatment Days 4 to 7) of this dosing group. Clinical signs observed were hypoactivity, piloerection, dehydration, ventral recumbent and tremors. In addition 5/6 females and 1/6 males of the mid dose were found dead/moribund and sacrificed within 8 days of treatment. Hence, the remaining surviving animals in this group were sacrificed on treatment Day 8. There were no clinical signs or mortality observed in the vehicle control and at 100 mg/kg bwt/day group rats. Based on the results of this dose-range-finding study a 28-day oral gavage study, followed by a 14-day recovery phase, in Wistar rats was performed with dose levels of 0, 15, 40, 80 and 100 mg/kg bw. All rats were observed for clinical signs, mortality and changes in body weight and food consumption during the whole study period. Blood samples were collected at the end of treatment for haematology and clin. chemistry. Rats of main and recovery groups were sacrificed at day 29 and day 43, respectively. All rats were subjected to detailed gross pathological examination at terminal sacrifice and histology was investigated in specified organs. Under the experimental conditions employed no mortality, no clinical signs and no test item-related changes were observed. Based on the findings of this study, it is concluded that the No Observed Adverse Effect Level (NOAEL) for (Benzothiazol-2-ylthio) acetic acid is 100 mg/kg bwt/day (highest dose tested) when administered repeatedly for 28 days to Wistar rats by oral route. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a25b66d-be2e-40c5-bd83-9f81777cf801/documents/e575dbf5-2562-4edd-ad01-6bdc3a463033_97225cd3-993a-4220-93e8-034851673727.html,,,,,, (benzothiazol-2-ylthio)acetic acid,6295-57-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a25b66d-be2e-40c5-bd83-9f81777cf801/documents/e575dbf5-2562-4edd-ad01-6bdc3a463033_97225cd3-993a-4220-93e8-034851673727.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat (benzothiazol-2-ylthio)acetic acid,6295-57-4, In order to determine the acute oral and acute dermal property of the test item two in vivo studies performed in 1985 are provided. The oral lethal dose (LD50) was determined to be 1580 mg/kg bw. The lethal dose (LD50) after dermal application was determined to be greater than 2000 mg/kg bw. No study is available for acuteinhalation toxicity. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a25b66d-be2e-40c5-bd83-9f81777cf801/documents/1e8a6ee0-9254-4674-8ceb-e8ccf451ddb9_97225cd3-993a-4220-93e8-034851673727.html,,,,,, (benzothiazol-2-ylthio)acetic acid,6295-57-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a25b66d-be2e-40c5-bd83-9f81777cf801/documents/1e8a6ee0-9254-4674-8ceb-e8ccf451ddb9_97225cd3-993a-4220-93e8-034851673727.html,,oral,LD50,"1,580 mg/kg bw",adverse effect observed, (benzothiazol-2-ylthio)acetic acid,6295-57-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a25b66d-be2e-40c5-bd83-9f81777cf801/documents/1e8a6ee0-9254-4674-8ceb-e8ccf451ddb9_97225cd3-993a-4220-93e8-034851673727.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, (benzothiazol-2-ylthio)succinic acid,95154-01-1," The LD50 value of the test item was above 5000 mg/kg bw, the highest concentration tested (CIBA-GEIGY, Ltd., 1984). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efcaff94-b7dc-4dde-8958-bef4fa53667a/documents/ecc5108f-5239-4c3e-9ccc-a852c8e502c8_cf4dbd3c-af6c-4f48-a704-0671e9b5b790.html,,,,,, (benzylamine)trifluoroboron,696-99-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ca886f7-ef96-4c9b-a666-84a1f6126c18/documents/IUC5-3ed9f587-d42a-4c2b-9a5a-31b9fef1107b_d7b46c11-f327-450b-b378-fc8d63e23062.html,,oral,LD50,641 mg/kg bw,adverse effect observed, "(butylamine)[[2,2'-thiobis[4-(1,1,3,3-tetramethylbutyl)phenolato]](2-)-O,O',S]nickel",14516-71-3," There is no repeated dose toxicity data available for UV-1084. A read across approach was conducted with 28 and 90 day repeated dose toxicity studies from TBBC (CAS No. 96-69-5). Read-across from TBBC - subacute NOEL (male/female, rat): 15 mg/kg bw/day (Equivalent or similar to OECD 407) Read-across from TBBC - subchronic NOAEL (male/female, rat): 30/35 mg/kg bw/day (Equivalent or similar to OECD 408/GLP) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56f7ce2f-99b6-4137-87d5-ae151f4cbb4a/documents/33660d4b-65b6-430c-a1bd-1fdecd309beb_63fd9816-82b4-43ec-a054-138b91876c9d.html,,,,,, "(butylamine)[[2,2'-thiobis[4-(1,1,3,3-tetramethylbutyl)phenolato]](2-)-O,O',S]nickel",14516-71-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56f7ce2f-99b6-4137-87d5-ae151f4cbb4a/documents/33660d4b-65b6-430c-a1bd-1fdecd309beb_63fd9816-82b4-43ec-a054-138b91876c9d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "(butylamine)[[2,2'-thiobis[4-(1,1,3,3-tetramethylbutyl)phenolato]](2-)-O,O',S]nickel",14516-71-3," Acute oral toxicity LD50: >2000 mg/kg bw (OECD 423, GLP) Acute dermal toxicity LD50: >2000 mg/kg bw (OECD 402, GLP) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56f7ce2f-99b6-4137-87d5-ae151f4cbb4a/documents/75554b52-077d-47e6-81fb-735ef247f09e_63fd9816-82b4-43ec-a054-138b91876c9d.html,,,,,, "(butylamine)[[2,2'-thiobis[4-(1,1,3,3-tetramethylbutyl)phenolato]](2-)-O,O',S]nickel",14516-71-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56f7ce2f-99b6-4137-87d5-ae151f4cbb4a/documents/75554b52-077d-47e6-81fb-735ef247f09e_63fd9816-82b4-43ec-a054-138b91876c9d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(butylamine)[[2,2'-thiobis[4-(1,1,3,3-tetramethylbutyl)phenolato]](2-)-O,O',S]nickel",14516-71-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56f7ce2f-99b6-4137-87d5-ae151f4cbb4a/documents/75554b52-077d-47e6-81fb-735ef247f09e_63fd9816-82b4-43ec-a054-138b91876c9d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, (chloromethyl)diethoxymethylsilane,2212-10-4,Oral : 1300 mg/kg bw (RTECS). Dermal: No data availableInhalation: LCLo50 = 2270 ppm/4h (RTECS) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6129cc6f-6055-45d8-80e9-1fbbfcbe7ad0/documents/a69b402e-0aa1-4c9e-9198-fcc1cbbce677_023227b8-5608-46bb-a3d8-fb26a728ca7a.html,,,,,, (chloromethyl)diethoxymethylsilane,2212-10-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6129cc6f-6055-45d8-80e9-1fbbfcbe7ad0/documents/a69b402e-0aa1-4c9e-9198-fcc1cbbce677_023227b8-5608-46bb-a3d8-fb26a728ca7a.html,,oral,LD50,"1,300 mg/kg bw",adverse effect observed, (chloromethyl)triethoxysilane,15267-95-5,"Oral: no data availableInhalation (OECD 413, RA from CAS 2530-87-2, rat): NOAEC=810.32 mg/m³Dermal: no data available ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11c92dd0-2003-4391-93d0-0d7701e150ae/documents/308070bd-fd18-40c4-9deb-3ed80b53ffee_50c7d773-ef65-44e7-82bb-c45926961da0.html,,,,,, (chloromethyl)triethoxysilane,15267-95-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11c92dd0-2003-4391-93d0-0d7701e150ae/documents/308070bd-fd18-40c4-9deb-3ed80b53ffee_50c7d773-ef65-44e7-82bb-c45926961da0.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,806 mg/m3,,rat (chloromethyl)triethoxysilane,15267-95-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11c92dd0-2003-4391-93d0-0d7701e150ae/documents/308070bd-fd18-40c4-9deb-3ed80b53ffee_50c7d773-ef65-44e7-82bb-c45926961da0.html,Repeated dose toxicity – local effects,inhalation,NOAEC,806 mg/m3,no adverse effect observed,rat (chloromethyl)triethoxysilane,15267-95-5,Oral (OECD 420): 2000 mg/kg bw < LD50 (female rat) < 5000 mg/kg bw. Dermal: No data availableInhalation (OECD 436): LC50 > 4700 mg/m³ air ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11c92dd0-2003-4391-93d0-0d7701e150ae/documents/0c727060-9845-4390-bad6-f7eb7dac86ba_50c7d773-ef65-44e7-82bb-c45926961da0.html,,,,,, "(E)-1-(2,6,6-trimethyl-1,3-cyclohexadien-1-yl)-2-buten-1-one",23726-93-4,"Read-across: 90-day oral repeated dose toxicity study : NOAEL = 30 mg/kg bw/day; LOAEL = 500 mg/kg bw/day (OECD 408, GLP, rel. 2) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8a135d8-78b2-4b96-a731-2d19b173a698/documents/IUC5-2c701843-808a-444e-a64f-1feafb5a4518_155de4f0-9e79-47bc-88ba-938dea7596c1.html,,,,,, "(E)-1-(2,6,6-trimethyl-1,3-cyclohexadien-1-yl)-2-buten-1-one",23726-93-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8a135d8-78b2-4b96-a731-2d19b173a698/documents/IUC5-2c701843-808a-444e-a64f-1feafb5a4518_155de4f0-9e79-47bc-88ba-938dea7596c1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "(E)-1-(2,6,6-trimethyl-1,3-cyclohexadien-1-yl)-2-buten-1-one",23726-93-4,"Acute toxicity: oral: LD50 > 2000 mg/kg bw (EU B.1 in rats, GLP, K, rel.1);Acute toxicity: dermal: LD50 Combined = 2900 mg/kg bw (similar to OECD 402, rats, read-across, K, rel. 2);Acute toxicity: inhalation: waiver. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8a135d8-78b2-4b96-a731-2d19b173a698/documents/IUC5-eb1f8569-1573-4090-babe-a230a71ff6e7_155de4f0-9e79-47bc-88ba-938dea7596c1.html,,,,,, "(E)-1-(2,6,6-trimethyl-1,3-cyclohexadien-1-yl)-2-buten-1-one",23726-93-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8a135d8-78b2-4b96-a731-2d19b173a698/documents/IUC5-eb1f8569-1573-4090-babe-a230a71ff6e7_155de4f0-9e79-47bc-88ba-938dea7596c1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(E)-1-(2,6,6-trimethyl-1,3-cyclohexadien-1-yl)-2-buten-1-one",23726-93-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8a135d8-78b2-4b96-a731-2d19b173a698/documents/IUC5-eb1f8569-1573-4090-babe-a230a71ff6e7_155de4f0-9e79-47bc-88ba-938dea7596c1.html,,dermal,LD50,"2,900 mg/kg bw",adverse effect observed, "(E)-1-(2,6,6-trimethyl-1-cyclohexen-1-yl)pent-1-en-3-one",63429-28-7,"Acute toxicity: oral: LD50 > 2000 mg/kg bw (OECD 420 in rats; GLP, K, Rel.1) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/544c57e6-4153-4d3d-af44-8b242fe0bacd/documents/IUC5-b9e46d32-a706-43ca-9dab-0b6dec09127c_05f43ceb-41d2-4a16-bf3e-f3b42fd480f0.html,,,,,, "(E)-1-(2,6,6-trimethyl-1-cyclohexen-1-yl)pent-1-en-3-one",63429-28-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/544c57e6-4153-4d3d-af44-8b242fe0bacd/documents/IUC5-b9e46d32-a706-43ca-9dab-0b6dec09127c_05f43ceb-41d2-4a16-bf3e-f3b42fd480f0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(E)-1,2-difluoroethylene",1630-78-0,"13‑Week Inhalation Toxicity in Rats with a 4-Week Recovery Period (OECD 413): Sprague-Dawley CDÒ rats were exposed via nose-only inhalation with 0 (Air control), 3,066, 10,439, or 14,972 ppm (E)-1,2-difluoroethylene (TKN1) once daily, 5 days a week, for 13 consecutive weeks. This study resulted in no test item-related adverse effects on mortality, clinical observations (including FOB/MA), body weights, food consumption, ophthalmology, hematology, coagulation, clinical chemistry, urinalysis, macroscopic necropsy observations or organ weights.  At the terminal necropsy, TKN1-associated degeneration (minimal to moderate) of the neuronal cells of the vomeronasal organ was present in the nose/turbinates in animals exposed to ≥ 3,066 ppm. The finding persisted following a 4-week recovery period in animals exposed to 14,972 ppm but was decreased in incidence and severity compared to the end of the exposures period. Moderate neuronal cell degeneration in animals exposed to 14,972 ppm TKN-1 may be adverse in this species. Thus, the No-Observed-Adverse-Effect-Level (NOAEL) for nasal pathology was determined to be 10,439 ppm.  The No-Observed-Adverse-Effect-Level (NOAEL) was otherwise determined to be 14,972 ppm.    4-Week Inhalation Toxicity Study in Rats with a 2-Week Recovery Period (OECD 412): TKN1 inhalation exposures from 3,000 to 15,000 ppm were generally well tolerated when rats were exposed for 6 hours/day, 5 days/week, for 4 consecutive weeks. However, adverse microscopic pathology findings in the nose/turbinates were seen at all exposure levels and thus the No-Observed-Adverse-Effect-Level (NOAEL) for nasal pathology was not determined.  The No-Observed-Adverse-Effect-Level (NOAEL) was otherwise determined to be 15,000 ppm.  ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d522b8c9-33c1-414a-9b44-94d104578b04/documents/7efd22f0-0a5b-4f2a-8062-e71d8d5f60c1_ca286984-e4e5-41ff-a1de-dbe0aa4506ba.html,,,,,, "(E)-1,2-difluoroethylene",1630-78-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d522b8c9-33c1-414a-9b44-94d104578b04/documents/7efd22f0-0a5b-4f2a-8062-e71d8d5f60c1_ca286984-e4e5-41ff-a1de-dbe0aa4506ba.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"14,972 ",, "(E)-1,2-difluoroethylene",1630-78-0,"Acute Inhalation Toxicity: Introduction Acute inhalation toxicity of TKNl was evaluated using Crl:CD(SD) rats of males and females in accordance with OECD test guideline (No. 403). The target exposure concentrations were set at 5000 ppm, 20000 ppm, and 100000 ppm. The test substance was exposed once at each target concentration to 6 males and 6 female rats for 4 hours by nose-only inhalation exposure. The observation period was set for 14 days, the rats were observed their clinical sign, weighed body weight and subjected to necropsy after the observation period.   Results The actual exposure concentrations were 5160 ppm, 20940 ppm, and 105660 ppm. Temperature and relative humidity of the test atmosphere did not have changes to affect the study results. In the result of the test substance exposure, no animals died in any groups. No changes were observed on clinical observation in any males or females of each group. Body weight loss was observed on day 2, the day of exposure designated as day 1, in males in groups exposed over 20000 ppm, and in females in all group.  Increased body weight was observed by day 4 in males and day 8 in females. No gross abnormalities were observed at necropsy in any males or females after the observation period.   Conclusion In conclusion, 50% lethal concentration of the test substance is more than 100000 ppm under the condition of this study. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Study scientifically not necessary. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Study assigned as reliability 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Study not scientifically necessary. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d522b8c9-33c1-414a-9b44-94d104578b04/documents/14a07963-8a88-4e79-926e-db50552db5fd_ca286984-e4e5-41ff-a1de-dbe0aa4506ba.html,,,,,, "(E)-1,2-difluoroethylene",1630-78-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d522b8c9-33c1-414a-9b44-94d104578b04/documents/14a07963-8a88-4e79-926e-db50552db5fd_ca286984-e4e5-41ff-a1de-dbe0aa4506ba.html,,inhalation,LC50,"> 100,000 ",no adverse effect observed, (E)-2-Methoxy-4-prop-1-en-1-ylphenyl acetate,5912-87-8,"Repeated dose toxicity oral: systemic NOAEL = 188 mg/kg bw/day in female mice (similar to OECD 408, read-across to trans-isoeugenol K, rel. 2) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b301e07-3749-445f-b807-ef56299ef30f/documents/7b7f16d0-52ba-460f-8c7e-0c72e45398c3_e7ab5bb5-d868-4d3b-a79a-dd964f43fe4a.html,,,,,, (E)-2-Methoxy-4-prop-1-en-1-ylphenyl acetate,5912-87-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b301e07-3749-445f-b807-ef56299ef30f/documents/7b7f16d0-52ba-460f-8c7e-0c72e45398c3_e7ab5bb5-d868-4d3b-a79a-dd964f43fe4a.html,Chronic toxicity – systemic effects,oral,NOAEL,188 mg/kg bw/day,,rat (E)-2-Methoxy-4-prop-1-en-1-ylphenyl acetate,5912-87-8," Acute toxicity: oral: LD50 = 3450 mg/kg bw (Read-across to Isoeugenyl acetate (reaction-mass of cis- and trans-isomers) similar to OECD 401 in rats, K, rel.2); Acute toxicity: dermal: LD50 > 5000 mg/kg bw (Read-across to Isoeugenyl acetate (reaction-mass of cis- and trans-isomers), similar to OECD 402, K, rel. 2); Acute toxicity: inhalation: waiver. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b301e07-3749-445f-b807-ef56299ef30f/documents/IUC5-4c3e4c8d-ed70-4876-b2e7-a33cf39dde48_e7ab5bb5-d868-4d3b-a79a-dd964f43fe4a.html,,,,,, (E)-2-Methoxy-4-prop-1-en-1-ylphenyl acetate,5912-87-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b301e07-3749-445f-b807-ef56299ef30f/documents/IUC5-4c3e4c8d-ed70-4876-b2e7-a33cf39dde48_e7ab5bb5-d868-4d3b-a79a-dd964f43fe4a.html,,oral,LD50,"3,450 mg/kg bw",adverse effect observed, (E)-2-Methoxy-4-prop-1-en-1-ylphenyl acetate,5912-87-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b301e07-3749-445f-b807-ef56299ef30f/documents/IUC5-4c3e4c8d-ed70-4876-b2e7-a33cf39dde48_e7ab5bb5-d868-4d3b-a79a-dd964f43fe4a.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, (E)-3-(benzyl(4-((4-nitrophenyl)diazenyl)phenyl)amino)propanenitrile,96662-24-7,"With regard to the suacute oral toxicity study, the 'No Observed Effect Level"" (NOEL) is 62.5 mg/kg body weight per day. However, no clear toxic effects were observed at the dose levels of 250 and 1000 mg/kg bw/day; hence the 'No Observed Adverse Effect Level"" (NOAEL) is considered to be 1000 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4df05610-31cf-4137-b3fd-eda3f0f2090d/documents/IUC5-c5619fa8-40dd-483c-9266-6a3ba341e57a_85bd0dde-ab88-438f-9d5f-7142843fed64.html,,,,,, (E)-3-(benzyl(4-((4-nitrophenyl)diazenyl)phenyl)amino)propanenitrile,96662-24-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4df05610-31cf-4137-b3fd-eda3f0f2090d/documents/IUC5-c5619fa8-40dd-483c-9266-6a3ba341e57a_85bd0dde-ab88-438f-9d5f-7142843fed64.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat (E)-3-(benzyl(4-((4-nitrophenyl)diazenyl)phenyl)amino)propanenitrile,96662-24-7,The substance has low oral or dermal toxicity. The LD50 for orsl or dermal administration is above 2000 mg/kg bw in male and female rats.   ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4df05610-31cf-4137-b3fd-eda3f0f2090d/documents/IUC5-e99910a7-6a71-492b-8a4d-9fbfe864a6cf_85bd0dde-ab88-438f-9d5f-7142843fed64.html,,,,,, (E)-3-(benzyl(4-((4-nitrophenyl)diazenyl)phenyl)amino)propanenitrile,96662-24-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4df05610-31cf-4137-b3fd-eda3f0f2090d/documents/IUC5-e99910a7-6a71-492b-8a4d-9fbfe864a6cf_85bd0dde-ab88-438f-9d5f-7142843fed64.html,,oral,LD0,"2,000 mg/kg bw",no adverse effect observed, (E)-3-(benzyl(4-((4-nitrophenyl)diazenyl)phenyl)amino)propanenitrile,96662-24-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4df05610-31cf-4137-b3fd-eda3f0f2090d/documents/IUC5-e99910a7-6a71-492b-8a4d-9fbfe864a6cf_85bd0dde-ab88-438f-9d5f-7142843fed64.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, (E)-3-formylbut-2-enyl acetate,26586-02-7,"No data are available on toxicity following subacute, subchronic or chronic exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec048858-1e19-478c-87dd-2a7c3d494ed8/documents/IUC5-21394426-485e-4303-bc14-dd7866a79d9b_41033c18-14a4-4de4-9fa3-85dc9ccc3949.html,,,,,, (E)-3-formylbut-2-enyl acetate,26586-02-7,"ORAL LD50 Combined: ca. 1430 mg/kg bw (BASF, 1969a)LD50 Combined: ca. 1380 mg/kg bw (BASF, 1969b)C5 acetate is of SLIGHT Toxicity based on the LD50 in male and female rats (combined).DERMAL No mortality occurred at a dose level of ca. 212 mg/kg bw (200 µl/kg bw; limit test)C5 acetate is of – if any - SLIGHT Toxicity.The study is reliable with some restrictions (only one dose level tested, short observation period, and limited examinations), but is regarded as study with weight of evidence.INHALATION LC50 Males =3.57 mg/L (95% C.I. 3.0 – 4.1)LC50 Females = 3.63 mg/L (95% C.I. 1.9 – 5.1)LC50 Combined = 3.6 mg/L (95% C.I. 3.1 – 4.1)C5 acetate is classified as being of SLIGHT Toxicity based on the LD50 in males (BASF, 1983).The results of the acute LC50 study are confirmed by two more ancient Inhalation Risk Tests. No mortality was observed when 12 rats/test were exposed to an atmosphere that had been saturated at 20°C with the volatile parts of the compounds (BASF, 1969a and b). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec048858-1e19-478c-87dd-2a7c3d494ed8/documents/IUC5-fbdd83f1-6302-4a89-987a-7671cb496257_41033c18-14a4-4de4-9fa3-85dc9ccc3949.html,,,,,, "(E)-3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one",15789-90-9,"Repeated dose toxicity, oral (Analogy CAS 127-51-5; OECD 408):- NOAEL male = 30 mg/kg bw/day, NOAEL female = 500 mg/kg bw/day- NOEL male = 5 mg/kg bw/day, NOEL female = 30 mg/kg bw/day- LOAEL male/female = 500 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7528e913-ea42-4320-8972-2e5a1b43468f/documents/cb53a298-6691-4695-ae5e-30112a5e0330_55d778b0-f878-4edf-b9a9-c92a240c7201.html,,,,,, "(E)-3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one",15789-90-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7528e913-ea42-4320-8972-2e5a1b43468f/documents/cb53a298-6691-4695-ae5e-30112a5e0330_55d778b0-f878-4edf-b9a9-c92a240c7201.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "(E)-3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one",15789-90-9,"Acute oral toxicity: - oral: LD50 cut-off >5000 mg/kg bw (rat, OECD 423), LD50 >5000 (rat) - dermal: LD50 >5000 mg/kg bw (rat) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7528e913-ea42-4320-8972-2e5a1b43468f/documents/10d98ad8-2645-4b93-8110-21e736d689c9_55d778b0-f878-4edf-b9a9-c92a240c7201.html,,,,,, "(E)-3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one",15789-90-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7528e913-ea42-4320-8972-2e5a1b43468f/documents/10d98ad8-2645-4b93-8110-21e736d689c9_55d778b0-f878-4edf-b9a9-c92a240c7201.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "(E)-3-methyl-4-(2,6,6-trimethylcyclohex-2-en-1-yl)but-3-en-2-one",15789-90-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7528e913-ea42-4320-8972-2e5a1b43468f/documents/10d98ad8-2645-4b93-8110-21e736d689c9_55d778b0-f878-4edf-b9a9-c92a240c7201.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, (E)-dodec-2-en-1-al,20407-84-5," Oral: LD50= > 2000 and the estimated LD50 cut-off > 5000mg/kg bw, female rat, OECD TG 423, 2015 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/551b7b79-c338-4fbb-9bda-4eaaf57cd726/documents/0d74e462-5d1e-4b7d-8dd2-0a87f6b30528_668826ed-5f79-4fc1-b0e6-92e5b3adb9b4.html,,,,,, (E)-dodec-2-en-1-al,20407-84-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/551b7b79-c338-4fbb-9bda-4eaaf57cd726/documents/0d74e462-5d1e-4b7d-8dd2-0a87f6b30528_668826ed-5f79-4fc1-b0e6-92e5b3adb9b4.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "(2E)-N,6,6-trimethyl-N-(1-naphthylmethyl)hept-2-en-4-yn-1-amine",91161-71-6,Single dose toxicity tests with the source substance demonstrate the low acute toxicity of the material. The data can be applied to the target substance. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58a2baf0-9be1-4821-ba3b-7c24912537b1/documents/4ad8e530-0908-4156-a32a-e11828ff4c09_0c457346-4473-4a08-b105-ec9348d245af.html,,,,,, "(E,Z)-2,6-dimethylocta-2,4,6-triene",7216-56-0," Acute toxicity, oral in rats: LD50 > 2000 mg/kg bw (OECD 423, GLP, K, Rel. 1) ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0592b1be-8582-44e9-a77f-be3b69d5c7fb/documents/e524b37a-2059-4855-a465-71092e23e29d_b71a33c8-e4f9-46a1-b050-97363b24d8b7.html,,,,,, "(E,Z)-2,6-dimethylocta-2,4,6-triene",7216-56-0,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0592b1be-8582-44e9-a77f-be3b69d5c7fb/documents/e524b37a-2059-4855-a465-71092e23e29d_b71a33c8-e4f9-46a1-b050-97363b24d8b7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(ethyl acetoacetato-O1',O3)(pentane-2,4-dionato-O,O')[propane-1,3-diolato(2-)-O,O']titanium",82089-64-3, In the combined repeated dose toxicity study with the reproduction / developmental toxicity screening test (OECD 422) no adverse effects were observed for repeated dose toxicity up to the highest tested dose (750 mg/kg bw/day). ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3349a6f5-4899-4761-ba6a-7ec2b150d0f1/documents/8bbf533d-b0a4-474c-9a28-c1fd917f31d7_ec510944-606e-4e43-9364-e1a0d4f46ef9.html,,,,,, "(ethyl acetoacetato-O1',O3)(pentane-2,4-dionato-O,O')[propane-1,3-diolato(2-)-O,O']titanium",82089-64-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3349a6f5-4899-4761-ba6a-7ec2b150d0f1/documents/8bbf533d-b0a4-474c-9a28-c1fd917f31d7_ec510944-606e-4e43-9364-e1a0d4f46ef9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "(ethyl acetoacetato-O1',O3)(pentane-2,4-dionato-O,O')[propane-1,3-diolato(2-)-O,O']titanium",82089-64-3," The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight (CLP - Category 4, H302: Harmful if swallowed.). The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight. The test item does not meet the criteria for classification according to CLP Regulation. The characterisation phase of the acute toxicity inhalation study according to OECD 436 resulted that a formal exposure is not required as it proved impossible to generate a suitable vapour atmosphere of the test item which would be in compliance with the test guideline. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3349a6f5-4899-4761-ba6a-7ec2b150d0f1/documents/9ab47667-e7f0-428d-be41-28da460d004b_ec510944-606e-4e43-9364-e1a0d4f46ef9.html,,,,,, "(ethyl acetoacetato-O1',O3)(pentane-2,4-dionato-O,O')[propane-1,3-diolato(2-)-O,O']titanium",82089-64-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3349a6f5-4899-4761-ba6a-7ec2b150d0f1/documents/9ab47667-e7f0-428d-be41-28da460d004b_ec510944-606e-4e43-9364-e1a0d4f46ef9.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "(ethyl acetoacetato-O1',O3)(pentane-2,4-dionato-O,O')[propane-1,3-diolato(2-)-O,O']titanium",82089-64-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3349a6f5-4899-4761-ba6a-7ec2b150d0f1/documents/9ab47667-e7f0-428d-be41-28da460d004b_ec510944-606e-4e43-9364-e1a0d4f46ef9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, (pentabromophenyl)methyl acrylate,59447-55-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9c99e89-ba42-434f-89e8-b9a03dad01cf/documents/IUC5-330ab6ce-c530-4cc7-b7bf-c83182e1f8ed_32b36dce-1844-4417-9d0e-ceb6d68bf5e0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat (pentabromophenyl)methyl acrylate,59447-55-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9c99e89-ba42-434f-89e8-b9a03dad01cf/documents/IUC5-0e7b764b-a8d6-413c-93b6-16c48572e35f_32b36dce-1844-4417-9d0e-ceb6d68bf5e0.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, (pentabromophenyl)methyl acrylate,59447-55-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9c99e89-ba42-434f-89e8-b9a03dad01cf/documents/IUC5-0e7b764b-a8d6-413c-93b6-16c48572e35f_32b36dce-1844-4417-9d0e-ceb6d68bf5e0.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, (pentabromophenyl)methyl acrylate,59447-55-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9c99e89-ba42-434f-89e8-b9a03dad01cf/documents/IUC5-0e7b764b-a8d6-413c-93b6-16c48572e35f_32b36dce-1844-4417-9d0e-ceb6d68bf5e0.html,,inhalation,LC50,"1,020 mg/m3",no adverse effect observed, (phenylethyl)benzene,38888-98-1,"Subacute:SAS-40: OECD 407: NOAEL 50 mg/kg SAS-305: OECD 407: NOAEL: 15 mg/kgPhenyl-tolyl-ethane: OECD 422: NOAEL: 30 mg/kgSAS-296: OECD 422: LOAEL males: 12.5 mg/kg, NOAEL females: 50 mg/kgChronic:SAS-296: similar to OECD 453: NOAEL: 4.83~5.72 mg/kg/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08cfabbe-43f8-49e0-a0dd-3cde02a757a9/documents/IUC5-907684cd-56d3-464c-96d9-b4e4aa1c9734_db150607-77c4-4f9d-b364-f1203c74843e.html,,,,,, (phenylethyl)benzene,38888-98-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08cfabbe-43f8-49e0-a0dd-3cde02a757a9/documents/IUC5-907684cd-56d3-464c-96d9-b4e4aa1c9734_db150607-77c4-4f9d-b364-f1203c74843e.html,Chronic toxicity – systemic effects,oral,NOAEL,4.83 mg/kg bw/day,,rat (phenylethyl)benzene,38888-98-1,"Acute oral toxicity:1,1-DPE was tested for acute oral toxicity according to OECD guideline 401 in groups of 3 male rats. Administration of up to 8.0 ml/kg orally resulted only in non-specific signs of treatment The acute oral LD50 of 1,1-DPE was determined as > 8 ml/kg bw.Acute toxicity via the inhalation route:1,1-DPE was tested for acute toxicity via the inhalation route in a study similar to OECD guideline 403 for 1 hour.Two 1-hour exposures of 4 male rats/exposure to vapor of the test material generated at room temperature (calculated to contain 1.6 and 1.5 mg/l based on weight of samples before and after exposures) resulted in slight, transient eye irritation. At the end of the exposure period the rats were somewhat excitable. However, all rats appeared healthy and gained weight during the 2-week observation period. No lesions attributable to exposure to the test material were observed upon gross pathological examination 2 weeks after exposure. Phenyl-tolyl-ethane was tested for acute toxicity via the inhalation route in a study according to OECD guideline 403 for 4 hours to two groups of five male and five female Wistar rats each group.The inhalatory LC50, 4h value of Phenyl-tolyl-ethane in Wistar rats was established to be within the range of 1 – 5 mg/L.Acute dermal toxicity:1,1-DPE was tested for acute dermal toxicity according to OECD guideline 402 in groups of 3 male rats. Administration of up to 4.0 ml/kg dermally resulted only in non-specific signs of treatment which were absent after 3 days. The acute dermal LD50 was established as > 4 ml/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08cfabbe-43f8-49e0-a0dd-3cde02a757a9/documents/IUC5-9bee2472-c383-4177-93bb-f3b79ec748da_db150607-77c4-4f9d-b364-f1203c74843e.html,,,,,, (phenylethyl)benzene,38888-98-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08cfabbe-43f8-49e0-a0dd-3cde02a757a9/documents/IUC5-9bee2472-c383-4177-93bb-f3b79ec748da_db150607-77c4-4f9d-b364-f1203c74843e.html,,oral,LD50,"8,000 mg/kg bw",no adverse effect observed, (phenylethyl)benzene,38888-98-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08cfabbe-43f8-49e0-a0dd-3cde02a757a9/documents/IUC5-9bee2472-c383-4177-93bb-f3b79ec748da_db150607-77c4-4f9d-b364-f1203c74843e.html,,dermal,LD50,"4,000 mg/kg bw",no adverse effect observed, (phenylethyl)benzene,38888-98-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08cfabbe-43f8-49e0-a0dd-3cde02a757a9/documents/IUC5-9bee2472-c383-4177-93bb-f3b79ec748da_db150607-77c4-4f9d-b364-f1203c74843e.html,,inhalation,LC50,"1,600 mg/m3",adverse effect observed, (R)-1-hydroxy-1-phenylacetone,1798-60-3,"rat oral: LD50 between 1470 and 2150 mg/kg bw (comparable to OECD 401 with restrictions, BASF AG 80/204, 1981)rat, inhalation: LC50 > 0.25 mg/L air/ 7hrs (BASF Inhalation Hazard Test, comparable to Annex V of OECD 403, BASF AG 80/204, 1981)rat, dermal: no data available ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b3059dc-e658-4e26-a2ad-7e25744e13e7/documents/IUC5-b9fd8a9e-58e4-4831-8396-395264aa5683_782b030a-8217-486e-826f-1d96dd47e680.html,,,,,, "(R)-2-(2,4-Difluorphenyl)-1,1-difluor-3-(tetrazol-1-yl)-1-{5-[4-(2,2,2-trifluorethoxy)-phenyl]-2-pyridyl}-2-propanol-(R,R)-tartrate",1809816-36-1," In an acute oral toxicity study in rats conducted according to OECD 423, mortality occurred at the limit dose of 2000 mg/kg bw. At 300 mg/kg bw, no mortality was observed. Hence, the LD50 cut off value is 1000 mg/kg bw and classification as Acute Tox. 4 , H302 is warranted in accordance with CLP Regulation 1272/2008. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51fea5e5-49b8-436f-be6f-168b5c84eb05/documents/551975a2-2b10-4bbe-860f-3812c0718976_c5f10e82-76de-470b-82de-d1125ae51936.html,,,,,, "(R)-2-(2,4-Difluorphenyl)-1,1-difluor-3-(tetrazol-1-yl)-1-{5-[4-(2,2,2-trifluorethoxy)-phenyl]-2-pyridyl}-2-propanol-(R,R)-tartrate",1809816-36-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51fea5e5-49b8-436f-be6f-168b5c84eb05/documents/551975a2-2b10-4bbe-860f-3812c0718976_c5f10e82-76de-470b-82de-d1125ae51936.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, "(R)-3,7-dimethyloct-6-enal",2385-77-5,"Read across: CitralChronic oral toxicity (similar to OECD TG 453, according to GLP; NTP 2003c-d)rat: NOAEL 100 mg/kg bw/dmouse: LOAEL 60 mg/kg bw/d for femalesSubchronic inhalation toxicity (Weight of evidence: Gaworski 1992,1993)rat: NOAEC 34 ppm = 215 mg/m3 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e73a1540-e5b5-42d1-bb91-541dd62be75e/documents/IUC5-ea72e43d-be36-4c02-a71e-2b5cde434f0e_45568ab0-64df-4e55-bc50-ff44558f3f41.html,,,,,, "(R)-3,7-dimethyloct-6-enal",2385-77-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e73a1540-e5b5-42d1-bb91-541dd62be75e/documents/IUC5-ea72e43d-be36-4c02-a71e-2b5cde434f0e_45568ab0-64df-4e55-bc50-ff44558f3f41.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,60 mg/kg bw/day,, "(R)-3,7-dimethyloct-6-enal",2385-77-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e73a1540-e5b5-42d1-bb91-541dd62be75e/documents/IUC5-ea72e43d-be36-4c02-a71e-2b5cde434f0e_45568ab0-64df-4e55-bc50-ff44558f3f41.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,215 mg/m3,, "(R)-3,7-dimethyloct-6-enal",2385-77-5,"Acute oral toxicity, rat: LD50 = 2423 mg/kg (BASF AG 1981)Acute dermal toxicity, rabbit: LD50 > 2500 - < 5000 mg/kg (Moreno 1973) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e73a1540-e5b5-42d1-bb91-541dd62be75e/documents/IUC5-bed75344-307b-4e95-a88a-565f1b6ff97f_45568ab0-64df-4e55-bc50-ff44558f3f41.html,,,,,, "(2R)-3-chloropropane-1,2-diol",57090-45-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): (QSAR prediction)(ACD/Tox Suite) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d80dd56-3fda-4d63-b958-a348f862cc4e/documents/78c26d2e-0464-44c9-82fb-a90b02bce236_7c9c2941-c1a6-4c25-a5af-4171e91ee31c.html,,,,,, "(2R)-3-chloropropane-1,2-diol",57090-45-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d80dd56-3fda-4d63-b958-a348f862cc4e/documents/78c26d2e-0464-44c9-82fb-a90b02bce236_7c9c2941-c1a6-4c25-a5af-4171e91ee31c.html,,oral,LD50,270 mg/kg bw,, (R)-6-(isopropyl)-3-methylcyclohex-2-en-1-one,4573-50-6," Oral (OECD 423), rat: LD50 > 5000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b3458b4-dc5f-4515-b656-c5f1c7115d59/documents/fdcbfc28-e96e-4022-a126-971fc384ae69_aab7f147-0172-42a8-9668-69edd5a7e79e.html,,,,,, (R)-lactic acid,10326-41-7," There are no reliable studies available for the assessment of the repeated dose toxicity endpoint with the target substance D-(-)-lactic acid. Therefore, available data from an oral sub-chronic repeated dose toxicity study conducted with a suitable read-across partner, calcium lactate, was used to assess the specific target organ toxicity of the target substance. Based on the results, no classification for specific target organ toxicity is warranted for target substance. For details and justification of read-across please refer to the report attached in section 13 of IUCLID. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82d246dd-ff67-44fe-98e7-d1d8b650b631/documents/IUC5-aceada23-d170-4cec-8f04-6207c6ef97d7_0cc1e698-7c5f-4895-b92d-6f16ca9d4de4.html,,,,,, (R)-lactic acid,10326-41-7," There are no studies available for the assessment of the oral, inhalation and dermal acute toxicity for the target substance D-(-)-lactic acid. Therefore, data available from the suitable read-across substance L(+)-lactic acid was used to assess the acute toxicity via the standard routes of administration (oral, inhalation, dermal). In all studies, the obtained LD50 or LC50 values for the oral, dermal or inhalation route are above the limit values of the relevant OECD guidelines. Thus, no classification for acute toxicity is warranted. For details and justification of read-across please refer to the report attached in section 13 of IUCLID. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82d246dd-ff67-44fe-98e7-d1d8b650b631/documents/IUC5-0f05aab7-b645-408a-96cf-313b420ea034_0cc1e698-7c5f-4895-b92d-6f16ca9d4de4.html,,,,,, (R)-lactic acid,10326-41-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82d246dd-ff67-44fe-98e7-d1d8b650b631/documents/IUC5-0f05aab7-b645-408a-96cf-313b420ea034_0cc1e698-7c5f-4895-b92d-6f16ca9d4de4.html,,oral,LD50,"3,543 mg/kg bw",adverse effect observed, (R)-lactic acid,10326-41-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82d246dd-ff67-44fe-98e7-d1d8b650b631/documents/IUC5-0f05aab7-b645-408a-96cf-313b420ea034_0cc1e698-7c5f-4895-b92d-6f16ca9d4de4.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, (R)-lactic acid,10326-41-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82d246dd-ff67-44fe-98e7-d1d8b650b631/documents/IUC5-0f05aab7-b645-408a-96cf-313b420ea034_0cc1e698-7c5f-4895-b92d-6f16ca9d4de4.html,,inhalation,LC50,> 7.94 mg/L,adverse effect observed, "(R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride",134-71-4,"In an acute oral toxicity study (similar to OECD 401), the LD50 was determined to be ca. 316 mg/kg bw and ca. 827 mg/kg bw for females and males, respectively, resulting in an combined LD50 of ca. 527 mg/kg bw. In an acute inhalation toxicity study (OECD 403), the LC50 was determined to be >2.2 mg/L. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/caef6dc0-3252-4ab9-af4c-79b501086a5a/documents/IUC5-d63dec1e-2db1-452d-a7ff-2c0514ce60c2_7e133734-d60a-4f59-9211-dd76c028f6f8.html,,,,,, "(R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride",134-71-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/caef6dc0-3252-4ab9-af4c-79b501086a5a/documents/IUC5-d63dec1e-2db1-452d-a7ff-2c0514ce60c2_7e133734-d60a-4f59-9211-dd76c028f6f8.html,,oral,LD50,527 mg/kg bw,adverse effect observed, "(S)-(4,5-dihydro-5-thioxo-1,3,4-thiadiazol-2-yl) benzenecarbothioate",51988-14-8,"Acute toxicity - oral: OECD 423, rat, GLP compliance, LD50(cut-off): > 5000mg/kg bw, LD50: > 2000 mg/kg bw Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): high quality ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49d9b9c0-1efc-4e7e-947d-1cb9299d12e6/documents/acc95930-f814-4c67-9f9d-160cb70b772d_40c877a5-8efb-4268-82e0-9e10e034dc3a.html,,,,,, "(S)-(4,5-dihydro-5-thioxo-1,3,4-thiadiazol-2-yl) benzenecarbothioate",51988-14-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49d9b9c0-1efc-4e7e-947d-1cb9299d12e6/documents/acc95930-f814-4c67-9f9d-160cb70b772d_40c877a5-8efb-4268-82e0-9e10e034dc3a.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(S)-1,2-epoxypropane",16088-62-3,"In rats and mice, repeated inhalation exposure to propylene oxide for 2 years produced chronic irritation of the nasal epithelium, with such effects being only marginal in nature at 30 ppm. However, concentrations of 100 ppm and above produced epithelial damage. In a 4 -week study in rats, small and reversible increases in nasal epithelium irritation occurred at 525 ppm propylene oxide. There is some evidence to indicate neurotoxicity in rats at a relatively high exposure level of 1,500 ppm after 7 weeks of exposure. No signs of neurotoxicity were observed in rats exposed to 300 ppm for 24 weeks.Repeated oral administration caused reduced body weight gain and gastric irritation, seen microscopically as reactive changes in the squamous epithelium of the fore stomach. No data are available on the toxicity of propylene oxide following repeated dermal exposure. The absence of significant toxic sequelae distant from the site of application following inhalation or oral administration suggests that concerns about target organ toxicity can be focused almost exclusively on tissues at the sites of initial contact. No additional classification for repeated exposure via inhalation, oral or dermal exposure is warranted. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ba7fbdf-342a-4b04-8c4b-1526bd4dd1ef/documents/IUC5-deb4fddb-db4a-4bfe-b63e-4d3a0ca27ec3_381a0e8d-b633-4ce7-995e-6587f80e02ef.html,,,,,, "(S)-1,2-epoxypropane",16088-62-3,"Propylene oxide is harmful by inhalation, oral and dermal routes of exposure. Signs of respiratory tract irritation were observed in the studies evaluated. Classification according to Annex I of Directive 67/548/EC is proposed as follows: R20/21/22 Harmful by inhalation, in contact with skin and if swallowed. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ba7fbdf-342a-4b04-8c4b-1526bd4dd1ef/documents/IUC5-4071c515-265a-4b5f-84f8-15f5eca57e5d_381a0e8d-b633-4ce7-995e-6587f80e02ef.html,,,,,, "(S)-2,2,3-trimethylcyclopent-3-ene-1-acetaldehyde",23727-15-3,"The acute oral toxicity for (+) CAMPHOLENIC ALDEHYDE was determined to be > 2000 mg/kg bw according to a study performed in agreement with OECD Guideline 401.(-) CAMPHOLENIC ALDEHYDE is an isomer of (+) CAMPHOLENIC ALDEHYDE. Data on (+) CAMPHOLENIC ALDEHYDE can be extrapolated to (-) CAMPHOLENIC ALDEHYDE. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is GLP complaint and has Klimisch score of 1. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Substance is an intermediate and only available data need to be submitted. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d490d3b4-d63e-4e15-8ac1-520a8ab61f4a/documents/407a7cc0-487f-4774-8117-2792de99d277_213e7aed-8bcf-448f-ac6e-3f04e1dc22b4.html,,,,,, (S)-2-chloropropionic acid,29617-66-1,"Four repeat dose studies have been reported. One was performed unequivocally with the racemic mixture and the 2nd (004) was assumed to use racemic material, the other two used the L(+)isomer specifically. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c1dde21-cf65-49a4-b950-f553093cac3a/documents/IUC5-a05245ea-e6e9-4f98-8e16-92ca9f5726be_bfddbc0c-ac8a-4e61-a833-81a623859026.html,,,,,, (S)-2-chloropropionic acid,29617-66-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c1dde21-cf65-49a4-b950-f553093cac3a/documents/IUC5-a05245ea-e6e9-4f98-8e16-92ca9f5726be_bfddbc0c-ac8a-4e61-a833-81a623859026.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat (S)-2-chloropropionic acid,29617-66-1,"L-2-Chloropropionic acid is classified under the CLP Regulation EC 1272/2008 Annex VI as Harmful if swallowed, R22 or Acute Toxicity 4 (H302) and Harmful in contact with skin, R21 or Acute Toxicity 4 (H312). A guideline study is reported which supports the Harmful if swallowed, R22 classification. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c1dde21-cf65-49a4-b950-f553093cac3a/documents/IUC5-4a72a1b3-fdc3-4773-bada-429acd973361_bfddbc0c-ac8a-4e61-a833-81a623859026.html,,,,,, (S)-2-chloropropionic acid,29617-66-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c1dde21-cf65-49a4-b950-f553093cac3a/documents/IUC5-4a72a1b3-fdc3-4773-bada-429acd973361_bfddbc0c-ac8a-4e61-a833-81a623859026.html,,oral,LD50,575 mg/kg bw,, (S)-5-fluoro-3-methylisobenzofuran-1(3H)-one,1803573-19-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): 1 (reliable without restriction) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/347fc7f3-df97-4862-af4b-8269f1c0e8df/documents/IUC5-92a35bf7-7f03-4294-94cd-b0c28728a5ad_ac762269-0b46-40d1-be7b-fae6ae03e718.html,,,,,, (S)-5-fluoro-3-methylisobenzofuran-1(3H)-one,1803573-19-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/347fc7f3-df97-4862-af4b-8269f1c0e8df/documents/IUC5-92a35bf7-7f03-4294-94cd-b0c28728a5ad_ac762269-0b46-40d1-be7b-fae6ae03e718.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, (tert-butoxymethyl)oxirane,7665-72-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/015782b7-a922-4d76-9633-5bc45244e8bb/documents/8a8b30f7-523f-4de7-b047-2dc45b7192cd_f940c050-85a1-45b4-bdbe-eed8188a4b51.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,400 mg/m3,,rat (tert-butoxymethyl)oxirane,7665-72-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/015782b7-a922-4d76-9633-5bc45244e8bb/documents/8a8b30f7-523f-4de7-b047-2dc45b7192cd_f940c050-85a1-45b4-bdbe-eed8188a4b51.html,Repeated dose toxicity – local effects,inhalation,NOAEC,130 mg/m3,adverse effect observed,rat (tert-butoxymethyl)oxirane,7665-72-7," In the key study for acute oral toxicity study conducted with the target substance tert-butyl glycidyl ether the oral LD50 was determined to be 2000 mg/kg bw. Based on this result classification as Acute Tox 4, H302 is warranted. That classification for Acute Oral Toxicity is warranted is further supported by an acute oral toxicity study conducted with the structural analogue n-butyl glycidyl ether. The oral LD50 obtained from an acute oral toxicity study in mice treated with this read-across partner was 1530 mg/kg bw. In an acute inhalation toxicity study five female Sprague Dawley rats were whole-body exposed for 7 hours to a vapour concentration of 17.72 mg/L of the target substance. No adverse signs of toxicity were observed. Based on the results the LD0 can be considered to be 17.72 mg/L and in accordance with the CLP regulation 1272/2008 no classification for acute inhalation toxicity is warranted. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/015782b7-a922-4d76-9633-5bc45244e8bb/documents/bf148261-0d6f-4083-be2a-89f78e936bd2_f940c050-85a1-45b4-bdbe-eed8188a4b51.html,,,,,, (tert-butoxymethyl)oxirane,7665-72-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/015782b7-a922-4d76-9633-5bc45244e8bb/documents/bf148261-0d6f-4083-be2a-89f78e936bd2_f940c050-85a1-45b4-bdbe-eed8188a4b51.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, (tetrapropenyl)succinic acid,27859-58-1,"Repeated dose Toxicity: Oral route As part of an OECD 408 repeat dose 90-day oral toxicity study, Wistar Han rats were orally (gavage) administered the test item for 90 days at dose levels 0 (corn oil), 50, 100 and 200 mg/kg/day, based on the results from 14-day and 28-day repeated dose oral toxicity studies. The test item was well tolerated at levels of 50 mg/kg/day. Adverse test item-related morphologic alterations were present in the liver and stomach of males and females at 100 and 200 mg/kg/day, with correlating macroscopic, organ weight and/or clinical pathology changes. From the results a No Observed Adverse Effect Level (NOAEL) of 50 mg/kg/day was established.  ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df4e4884-e6ba-47ba-9867-d0ffe354596e/documents/dc640a82-18a1-4c1e-93c0-a7224738f2c9_d4d8cdad-2d13-4a58-97a9-10ce6b465952.html,,,,,, (tetrapropenyl)succinic acid,27859-58-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df4e4884-e6ba-47ba-9867-d0ffe354596e/documents/dc640a82-18a1-4c1e-93c0-a7224738f2c9_d4d8cdad-2d13-4a58-97a9-10ce6b465952.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat (tetrapropenyl)succinic acid,27859-58-1,"Under the conditions of the study, the LD50 and 95 % confidence limits were determined to be 2700 (2300 to 3500) mg/kg for males and 2100 (1100 to 3400) mg/kg for females. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df4e4884-e6ba-47ba-9867-d0ffe354596e/documents/d9d548f0-6b47-4cde-95bc-04f85b5ef95f_d4d8cdad-2d13-4a58-97a9-10ce6b465952.html,,,,,, (tetrapropenyl)succinic acid,27859-58-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df4e4884-e6ba-47ba-9867-d0ffe354596e/documents/d9d548f0-6b47-4cde-95bc-04f85b5ef95f_d4d8cdad-2d13-4a58-97a9-10ce6b465952.html,,oral,LD50,"2,100 mg/kg bw",no adverse effect observed, "(thiodi-4,1-phenylene)-bis-(diphenylbis)(OC-6,11)hexafluoroantimonate",89452-37-9,"(sulfanediyldibenzene-4,1-diyl)bis(diphenylsulfonium) bis(hexafluoroantimonate) was administered daily by oral gavage to male and female Wistar rats, for 2 weeks before mating, during mating, and until sacrifice for males, or through gestation and until Day 13 p.p. for females, at dose-levels of 10, 30 and 100 mg/kg/day. Based on the experimental conditions and results of this study, the No Observed Adverse Effect Level (NOAEL) for parental toxicity (systemic) was considered to be >= 100 mg/kg/day, based on the absence of adverse effects at this dose (OECD 422, K, Rel.1). There were no studies available for inhalation or dermal route. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/94012a80-55fd-4af4-b0ed-d806a5d1691d/documents/a49c8350-784d-403c-892a-95792a4f92c1_1ad9751d-28ea-4cab-a845-cc8c83c2c7b8.html,,,,,, "(thiodi-4,1-phenylene)-bis-(diphenylbis)(OC-6,11)hexafluoroantimonate",89452-37-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/94012a80-55fd-4af4-b0ed-d806a5d1691d/documents/a49c8350-784d-403c-892a-95792a4f92c1_1ad9751d-28ea-4cab-a845-cc8c83c2c7b8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "(thiodi-4,1-phenylene)-bis-(diphenylbis)(OC-6,11)hexafluoroantimonate",89452-37-9,No mortality was observed in rats following a single oral or dermal exposure to the registered substance at up to 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94012a80-55fd-4af4-b0ed-d806a5d1691d/documents/816dd43b-8741-4fbd-8122-55ea2fc3d735_1ad9751d-28ea-4cab-a845-cc8c83c2c7b8.html,,,,,, "(thiodi-4,1-phenylene)-bis-(diphenylbis)(OC-6,11)hexafluoroantimonate",89452-37-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94012a80-55fd-4af4-b0ed-d806a5d1691d/documents/816dd43b-8741-4fbd-8122-55ea2fc3d735_1ad9751d-28ea-4cab-a845-cc8c83c2c7b8.html,,oral,LD0,"2,000 mg/kg bw",no adverse effect observed, "(thiodi-4,1-phenylene)-bis-(diphenylbis)(OC-6,11)hexafluoroantimonate",89452-37-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94012a80-55fd-4af4-b0ed-d806a5d1691d/documents/816dd43b-8741-4fbd-8122-55ea2fc3d735_1ad9751d-28ea-4cab-a845-cc8c83c2c7b8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, (tris[2-(2-hydroxyethoxy)ethyl] borate ),71035-05-7," In contact with water,mist or rat plasma, the substance immediately and spontaneously hydrolize into its parent substances: diethylene glycol and boric acid. Boric acid Eight out of the ten males and six out of the ten females from the 20000 ppm group died and one of the ten males from the 10000 ppm group died before end of study. Symptoms included nervousness, haunched appearance, dehydration, foot lesions and scaly tails. Incidences of extra medullary heamatopoiesis of spleen observed of varying severity in all dose groups for both males and females and hyperkeratosis and/or acanthosis of the stomach observed at the highest dose only in both males and females. At doses > 5,000 ppm (142 mg B/kg bw for the male), degeneration or atrophy of the seminiferous tubules was observed Diethylen glycol A single group of eight adult female Sprague-Dawley rats was exposed daily to 0 or 200 mg/kg body weight DEG in drinking water for 90 days. In a preliminary acute range-finding study conducted as part of this study, single oral (gavage) doses of 700, 2,000, or 8,000 mg/kg DEG were shown to produce dose-related changes in renal function, as measured by several urinalysis parameters. A single (gavage) dose of 200 mg/kg DEG produced no changes. Oral (drinking water) exposure to 200 mg/kg/day DEG for 90 days resulted in no significant effects on body weight or relative kidney weight versus the control groups. ( ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acabd0bd-9b1a-4064-9826-cf34eb34c660/documents/cdd67dc4-29e4-415f-8456-ea6eb3342d95_3fe21ac6-4e58-4518-9d9b-6104920f6db5.html,,,,,, (tris[2-(2-hydroxyethoxy)ethyl] borate ),71035-05-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acabd0bd-9b1a-4064-9826-cf34eb34c660/documents/d725e775-3119-4f3c-9673-b8f5864b7c62_3fe21ac6-4e58-4518-9d9b-6104920f6db5.html,,oral,LD50,"8,000 mg/kg bw",no adverse effect observed, (vinyloxy)cyclohexane,2182-55-0,The test item cyclohexylvinylether was tested for repeated dose inhalation toxicity in a GLP study with rats according to OECD 413. The NOAEC for systemic effects was determined to be 500 mg/m³ bw . For local effects a LOEC of 100 mg/m³ was determined. No oral and dermal repeated dose study was conducted since inhalation is the relevant route of exposure. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd671168-6f15-484e-8e10-4ffb05c94779/documents/IUC5-b3f2a403-5f8d-4daa-a5c1-c2adf0a4aae7_4aad1827-0613-4a32-a923-cba67affefa5.html,,,,,, (vinyloxy)cyclohexane,2182-55-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd671168-6f15-484e-8e10-4ffb05c94779/documents/IUC5-b3f2a403-5f8d-4daa-a5c1-c2adf0a4aae7_4aad1827-0613-4a32-a923-cba67affefa5.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,500 mg/m3,,rat (vinyloxy)cyclohexane,2182-55-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd671168-6f15-484e-8e10-4ffb05c94779/documents/IUC5-b3f2a403-5f8d-4daa-a5c1-c2adf0a4aae7_4aad1827-0613-4a32-a923-cba67affefa5.html,Repeated dose toxicity – local effects,inhalation,LOAEC,100 mg/m3,adverse effect observed,rat (vinyloxy)cyclohexane,2182-55-0,The test item cyclohexylvinylether was tested for acute oral toxicity in a GLP study according to OECD 423 on oral gavage in rats. The LD50 was determined to be greater than 2000 mg/kg bw in female rats.The test item cyclohexylvinylether was tested for acute dermal toxicity in a GLP and guideline study according to OECD guideline 402 on dermal administration in rats. The LD50 was determined to be greater than 2000 mg/kg bw in male and female rats.The test item cyclohexylvinylether was tested for acute inhalation toxicity in a GLP study according to OECD 403 in rats. Under the conditions of this study the LC50 for male and female rats after vapor inhalation exposure of Cyclohexylvinylether was estimated to be > 22007 mg/m3(analytical concentration). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd671168-6f15-484e-8e10-4ffb05c94779/documents/IUC5-21514df8-29ed-48de-a555-fa9f591b6d5c_4aad1827-0613-4a32-a923-cba67affefa5.html,,,,,, (vinyloxy)cyclohexane,2182-55-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd671168-6f15-484e-8e10-4ffb05c94779/documents/IUC5-21514df8-29ed-48de-a555-fa9f591b6d5c_4aad1827-0613-4a32-a923-cba67affefa5.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, (vinyloxy)cyclohexane,2182-55-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd671168-6f15-484e-8e10-4ffb05c94779/documents/IUC5-21514df8-29ed-48de-a555-fa9f591b6d5c_4aad1827-0613-4a32-a923-cba67affefa5.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, (vinyloxy)cyclohexane,2182-55-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd671168-6f15-484e-8e10-4ffb05c94779/documents/IUC5-21514df8-29ed-48de-a555-fa9f591b6d5c_4aad1827-0613-4a32-a923-cba67affefa5.html,,inhalation,discriminating conc.,"22,007 mg/m3",no adverse effect observed, (Z)-[(octadec-9-enyloxy)methyl]oxirane,60501-41-9,"Acute oral LD50 > 2000 mg/kg bw (BASF, 1988) ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10dba497-228d-4f8a-b991-fc6d645c1ea1/documents/IUC5-038605a8-4577-4f3c-96ca-2fc29e16966e_7b934e1d-0589-4cea-bd35-07aef841f036.html,,,,,, (Z)-[(octadec-9-enyloxy)methyl]oxirane,60501-41-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10dba497-228d-4f8a-b991-fc6d645c1ea1/documents/IUC5-038605a8-4577-4f3c-96ca-2fc29e16966e_7b934e1d-0589-4cea-bd35-07aef841f036.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "(Z)-1,3,3,3-tetrafluoroprop-1-ene",29118-25-0, Acute oral toxicity: LD50 = approx 1242 mg/kg bw (QSAR) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3cfd82e-8080-489c-8693-063b13e5b470/documents/5a3addc0-0e69-4d7e-badc-691059f641b7_2a4376e3-1b30-420a-a1c3-d2510981bacb.html,,,,,, "(Z)-1,3,3,3-tetrafluoroprop-1-ene",29118-25-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3cfd82e-8080-489c-8693-063b13e5b470/documents/5a3addc0-0e69-4d7e-badc-691059f641b7_2a4376e3-1b30-420a-a1c3-d2510981bacb.html,,oral,LD50,"1,242 mg/kg bw",adverse effect observed, (3Z)-1-(but-2-en-1-yloxy)hex-3-ene,888744-18-1,"Oral: NOAEL (rat): Repeated dose 28-day oral study (oral gavage to rats; Arachis oil vehicle) : 0 (control), 15, 150 and 1000 mg/kg/day generated a NOAEL (male/female) = ≥ 1000 mg/kg bw /day OECD TG 407, 2008 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdd96bf7-f308-4ce4-b9da-b4125ff8a771/documents/bd664e51-b219-49ad-a397-4b311bd04c5a_c0f42c54-b9ef-4368-a61a-e88e7a1e49e3.html,,,,,, (3Z)-1-(but-2-en-1-yloxy)hex-3-ene,888744-18-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdd96bf7-f308-4ce4-b9da-b4125ff8a771/documents/bd664e51-b219-49ad-a397-4b311bd04c5a_c0f42c54-b9ef-4368-a61a-e88e7a1e49e3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat (3Z)-1-(but-2-en-1-yloxy)hex-3-ene,888744-18-1,"Oral (rat): measured LD50 > 2000 and the estimated LD50 cut-off was considered to be < 5000 mg/kg bw, male/female rat, OECD TG 423, 2006 Dermal (rat): measured LD50 > 2000 mg/kg bw and the estimated LD50 cut-off value was considered to be > 5000 mg/kg bw, male/female rat, OECD TG 402, 2007 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdd96bf7-f308-4ce4-b9da-b4125ff8a771/documents/86c7671f-6dc4-4d58-a680-1e772e372c5d_c0f42c54-b9ef-4368-a61a-e88e7a1e49e3.html,,,,,, (3Z)-1-(but-2-en-1-yloxy)hex-3-ene,888744-18-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdd96bf7-f308-4ce4-b9da-b4125ff8a771/documents/86c7671f-6dc4-4d58-a680-1e772e372c5d_c0f42c54-b9ef-4368-a61a-e88e7a1e49e3.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, (3Z)-1-(but-2-en-1-yloxy)hex-3-ene,888744-18-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdd96bf7-f308-4ce4-b9da-b4125ff8a771/documents/86c7671f-6dc4-4d58-a680-1e772e372c5d_c0f42c54-b9ef-4368-a61a-e88e7a1e49e3.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "(Z)-2-butene-1,4-diol",6117-80-2,subacute oral NOAEL = 20 mg/kg bw/day ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/402c6203-6216-4eb5-91c0-c3a9380c3cc3/documents/IUC5-c339295e-7eff-4d32-a701-9a7541dd23ca_492519c4-d678-4c05-af65-34b8bc4a8078.html,,,,,, "(Z)-2-butene-1,4-diol",6117-80-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/402c6203-6216-4eb5-91c0-c3a9380c3cc3/documents/IUC5-c339295e-7eff-4d32-a701-9a7541dd23ca_492519c4-d678-4c05-af65-34b8bc4a8078.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "(Z)-2-butene-1,4-diol",6117-80-2,Oral LD50: 856 mg/kg bwDermal LD50: >2000 mg/kg bw (estimated); >200 mg/kg (measured)Inhalation LC0: 1.6 mg/l ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/402c6203-6216-4eb5-91c0-c3a9380c3cc3/documents/IUC5-95dfcdb5-2e5c-46f2-8056-4301911fcaf4_492519c4-d678-4c05-af65-34b8bc4a8078.html,,,,,, "(Z)-2-butene-1,4-diol",6117-80-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/402c6203-6216-4eb5-91c0-c3a9380c3cc3/documents/IUC5-95dfcdb5-2e5c-46f2-8056-4301911fcaf4_492519c4-d678-4c05-af65-34b8bc4a8078.html,,oral,LD50,856 mg/kg bw,adverse effect observed, (Z)-cyclooctene,931-87-3,"In a 28-day oral gavage study reduced body weights were noted in high dose male rats at 500 mg/kg bw/d which proved to be reversible upon 14-day recovery (Krueger, 1997).  However, the absolute bodyweight changes of the high dose male group at the end of the recovery period showed still a statistically significant reduction when compared with the control. Therefore, in the experimental conditions, the no-observed-adverse-effect level (NOAEL) is 150 mg/kg bw/day. There are no data available for a 90-day oral toxixity study. A data waiver was claimed. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57929e54-b0b2-4d67-adb8-4a40ccf7b87a/documents/IUC5-105da744-8c7d-4943-89dd-41c7872a9590_04a9bc05-58ed-4d2c-b2ef-5bc696c82ca7.html,,,,,, (Z)-cyclooctene,931-87-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57929e54-b0b2-4d67-adb8-4a40ccf7b87a/documents/IUC5-105da744-8c7d-4943-89dd-41c7872a9590_04a9bc05-58ed-4d2c-b2ef-5bc696c82ca7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat (Z)-cyclooctene,931-87-3,"Studies on acute toxicity by the oral route (Mürmann, 1983) and by the dermal route (Mürman, 1983) in rats and mice demonstrated that the test item is practically nontoxic. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57929e54-b0b2-4d67-adb8-4a40ccf7b87a/documents/IUC5-074087d8-a56d-4c8a-93f8-1464c52e1bfb_04a9bc05-58ed-4d2c-b2ef-5bc696c82ca7.html,,,,,, (Z)-cyclooctene,931-87-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57929e54-b0b2-4d67-adb8-4a40ccf7b87a/documents/IUC5-074087d8-a56d-4c8a-93f8-1464c52e1bfb_04a9bc05-58ed-4d2c-b2ef-5bc696c82ca7.html,,oral,LD50,"4,550 mg/kg bw",no adverse effect observed, (Z)-cyclooctene,931-87-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57929e54-b0b2-4d67-adb8-4a40ccf7b87a/documents/IUC5-074087d8-a56d-4c8a-93f8-1464c52e1bfb_04a9bc05-58ed-4d2c-b2ef-5bc696c82ca7.html,,dermal,LD50,"> 10,000 mg/kg bw",no adverse effect observed, (Z)‐ethyl 2‐methylpent‐3‐enoate,58625-89-1,Acute oral toxicity: similar to OECD TG 401: LD50 >5000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/238932db-3877-41fd-97ac-eff2298502ae/documents/1973d098-4bd5-4080-bc48-2d5016fd1f8d_1e567a7f-a89e-46cd-9405-0c9925fa59aa.html,,,,,, (Z)‐ethyl 2‐methylpent‐3‐enoate,58625-89-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/238932db-3877-41fd-97ac-eff2298502ae/documents/1973d098-4bd5-4080-bc48-2d5016fd1f8d_1e567a7f-a89e-46cd-9405-0c9925fa59aa.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "(Z)-N-(3-aminopropyl)-N'-9-octadecenylpropane-1,3-diamine",28872-01-7," There is no study on Oleyl dipropylene triamine itself available. However sufficient data is available from cross-reading to data available on similar product Tallow (C16-18) dipropylene triamine, as well on other substances from the category with same linear-alkyl dipropylene triamine structures. A combined repeated dose/reproduction screening toxicity study with Coco dipropylene triamine is available, leading to a LOAEL of 10 mg/kgbw/day based on foamy macrophage infiltration in the ileum and jejunum and foamy macrophage foci in the mesenteric lymph nodes observed at this dose level. Cross-reading to a 90 day oral study (OECD 408, GLP) on Tallow dipropylenetriamine results to a NOAEL of 2.5 mg/kg bw/day, also based on foamy macrophage infiltration in the ileum and jejunum. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9121971-41ca-4b47-a40a-17087a09188d/documents/021450c8-3ce3-4695-8523-a031719c17e3_2275f9d9-09f5-4497-b8c0-115d806e3bca.html,,,,,, "(Z)-N-(3-aminopropyl)-N'-9-octadecenylpropane-1,3-diamine",28872-01-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9121971-41ca-4b47-a40a-17087a09188d/documents/021450c8-3ce3-4695-8523-a031719c17e3_2275f9d9-09f5-4497-b8c0-115d806e3bca.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,2.5 mg/kg bw/day,,rat "(Z)-N-(3-aminopropyl)-N'-9-octadecenylpropane-1,3-diamine",28872-01-7, Acute toxicity: Oral LD50 between 300 and 2000 mg/kg for rat (LD50 cut-off: 500 mg/kg bw). No data is available on acute toxicity via inhalation or dermal route. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9121971-41ca-4b47-a40a-17087a09188d/documents/18ab7055-e7ee-49bf-a7c4-57782d2c65eb_2275f9d9-09f5-4497-b8c0-115d806e3bca.html,,,,,, "(Z)-N-(3-aminopropyl)-N'-9-octadecenylpropane-1,3-diamine",28872-01-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9121971-41ca-4b47-a40a-17087a09188d/documents/18ab7055-e7ee-49bf-a7c4-57782d2c65eb_2275f9d9-09f5-4497-b8c0-115d806e3bca.html,,oral,LD50,500 mg/kg bw,adverse effect observed, (Z)-N-[2-(2-hydroxyethoxy)ethyl]-9-octadecenamide,20429-33-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57935057-4ea6-46a5-8441-4d3bc6bf88c2/documents/60a86b26-dd74-425d-b4c7-65972a3dc2ac_a1bc0fb4-f348-4ca2-ab73-bc498bceb246.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat (Z)-N-[2-(2-hydroxyethoxy)ethyl]-9-octadecenamide,20429-33-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57935057-4ea6-46a5-8441-4d3bc6bf88c2/documents/43354946-4175-45a4-9cc3-00d6baf66dfc_a1bc0fb4-f348-4ca2-ab73-bc498bceb246.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, (Z)-N-[2-(2-hydroxyethoxy)ethyl]-9-octadecenamide,20429-33-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57935057-4ea6-46a5-8441-4d3bc6bf88c2/documents/43354946-4175-45a4-9cc3-00d6baf66dfc_a1bc0fb4-f348-4ca2-ab73-bc498bceb246.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "(Z)-N-9-octadecenylpropane-1,3-diamine",7173-62-8," Oleyl-diamine: 28d (OECD 407, GLP): NOAEL 1.25 mg/kg bw/day; C12-14-diamine: 28 day oral gavage (OECD 407, GLP): NOAEL 0.4 mg/kg bw/day C12-14-diamine: 90 day oral gavage (OECD 408, GLP): NOAEL 0.4 mg/kg bw/day No study available for inhalation or dermal exposure: (Z)-N-9-octadecenyl-1,3-diaminopropane (Oleyl diamine) is a liquid/paste with a vapour pressure less than 0.0015 Pa at 20°C (value is an overestimation as it is based on read-across from shorter chain C12-14-diamine). Also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Oleyl diamine is corrosive to the skin. The skin is therefore not a preferred route for testing to evaluate systemic toxicity following repeated dose. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1bbd42e0-6ea8-49a3-abe8-53bb5fe8abae/documents/IUC5-f324fc98-55fa-466f-8e53-9dcc996eeceb_a73be24d-c2d7-4916-ab9d-ba9b76f27ae5.html,,,,,, "(Z)-N-9-octadecenylpropane-1,3-diamine",7173-62-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1bbd42e0-6ea8-49a3-abe8-53bb5fe8abae/documents/IUC5-f324fc98-55fa-466f-8e53-9dcc996eeceb_a73be24d-c2d7-4916-ab9d-ba9b76f27ae5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.4 mg/kg bw/day,,rat "(Z)-N-9-octadecenylpropane-1,3-diamine",7173-62-8, LD50 of Oleyl diamine ranges between 500 and 1000 mg/kg bw; limited exposure via inhalation; study by dermal route not necessary due to low systemic toxicity and severe dermal irritation. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bbd42e0-6ea8-49a3-abe8-53bb5fe8abae/documents/IUC5-265a7886-1bbe-4f5d-a8de-cfeef188c1f5_a73be24d-c2d7-4916-ab9d-ba9b76f27ae5.html,,,,,, "(Z)-N-9-octadecenylpropane-1,3-diamine",7173-62-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bbd42e0-6ea8-49a3-abe8-53bb5fe8abae/documents/IUC5-265a7886-1bbe-4f5d-a8de-cfeef188c1f5_a73be24d-c2d7-4916-ab9d-ba9b76f27ae5.html,,oral,LD50,500 mg/kg bw,adverse effect observed, (Z)-pent-2-enenitrile,25899-50-7,"Repeated dose toxicity, oral: NOAEL = 3 mg/kg bw/day based on degeneration of the olfactory mucosa at 10 mg/kg bw/day observed only on 2/10 females (OECD 422, GLP).Repeated dose toxicity, inhalation: NOAEL = 3 ppm based on microscopic nasal lesions observed in female rats at 30 ppm and above, on the changes in sorbitol dehydrogenase activity at 30 ppm and above and on the body weight reduction observed in males at 30 ppm. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d172f6cc-1f5c-425e-8ec8-b4a4c8ca1466/documents/IUC5-24083ef9-346a-4dab-b321-e82d58128c24_0c95833a-4851-46ac-8196-a5d89b470838.html,,,,,, (Z)-pent-2-enenitrile,25899-50-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d172f6cc-1f5c-425e-8ec8-b4a4c8ca1466/documents/IUC5-24083ef9-346a-4dab-b321-e82d58128c24_0c95833a-4851-46ac-8196-a5d89b470838.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,3 mg/kg bw/day,,rat (Z)-pent-2-enenitrile,25899-50-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d172f6cc-1f5c-425e-8ec8-b4a4c8ca1466/documents/IUC5-24083ef9-346a-4dab-b321-e82d58128c24_0c95833a-4851-46ac-8196-a5d89b470838.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,9.95 mg/m3,,rat (Z)-pent-2-enenitrile,25899-50-7,"Oral: LD50: 198 mg/kg bw for male rats (kr 2, similar to OECD 401)Dermal: LD50: < 800 mg/kg bw for male rats (kr 2, similar to OECD 402)Inhalation: LC50: 2.82 mg/L for rats (kr 1, EPA OTS 798.1150) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d172f6cc-1f5c-425e-8ec8-b4a4c8ca1466/documents/IUC5-f6502080-ec72-4be8-8faa-a35c6e13793f_0c95833a-4851-46ac-8196-a5d89b470838.html,,,,,, (Z)-pent-2-enenitrile,25899-50-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d172f6cc-1f5c-425e-8ec8-b4a4c8ca1466/documents/IUC5-f6502080-ec72-4be8-8faa-a35c6e13793f_0c95833a-4851-46ac-8196-a5d89b470838.html,,oral,LD50,198 mg/kg bw,, (Z)-pent-2-enenitrile,25899-50-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d172f6cc-1f5c-425e-8ec8-b4a4c8ca1466/documents/IUC5-f6502080-ec72-4be8-8faa-a35c6e13793f_0c95833a-4851-46ac-8196-a5d89b470838.html,,inhalation,LC50,"2,820 mg/m3",, "(Z,Z)-di-9-octadecenyl phosphonate",25088-57-7," No studies for repeated dose toxicity are required for a 1 -10 tonnage band however, see below for consideration made regarding classification. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef20c954-6d26-43b2-9ffc-5a5febf7da4a/documents/e182f14a-69fa-484e-b617-79c527dc37f9_fbe20d41-7590-4554-ad97-7a617f4530ab.html,,,,,, "(Z,Z)-di-9-octadecenyl phosphonate",25088-57-7," Oral LD50 female rats = >2000 mg/kg bw; OECD 420; Sanders, A. (2018) According to the CLP, the test item does not meet the criteria for acute oral toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef20c954-6d26-43b2-9ffc-5a5febf7da4a/documents/8cbc7c9a-b4b7-45b4-9503-d21791b8d1b3_fbe20d41-7590-4554-ad97-7a617f4530ab.html,,,,,, "(2S,3R,4S,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)-2-methoxytetrahydro-2H-pyran-3,4,5-triol with 2-butyne-1, 4-diol (1:1)",960404-59-5,"One key 28 day study, rats, oral was conducted. (OECD 422) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9809a606-cc88-4249-b9ba-700868502fd8/documents/IUC5-c95e24b2-7d74-44cc-afae-37fa376f576e_049aab04-1edd-49d0-bf41-5eceafcda093.html,,,,,, "(2S,3R,4S,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)-2-methoxytetrahydro-2H-pyran-3,4,5-triol with 2-butyne-1, 4-diol (1:1)",960404-59-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9809a606-cc88-4249-b9ba-700868502fd8/documents/IUC5-c95e24b2-7d74-44cc-afae-37fa376f576e_049aab04-1edd-49d0-bf41-5eceafcda093.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "(2S,3R,4S,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)-2-methoxytetrahydro-2H-pyran-3,4,5-triol with 2-butyne-1, 4-diol (1:1)",960404-59-5,"Two in-vivo key studies available for acute toxicity, oral and dermal. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9809a606-cc88-4249-b9ba-700868502fd8/documents/IUC5-5a101384-d456-467a-b3ff-ccf2d3267200_049aab04-1edd-49d0-bf41-5eceafcda093.html,,,,,, "(2S,3R,4S,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)-2-methoxytetrahydro-2H-pyran-3,4,5-triol with 2-butyne-1, 4-diol (1:1)",960404-59-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9809a606-cc88-4249-b9ba-700868502fd8/documents/IUC5-5a101384-d456-467a-b3ff-ccf2d3267200_049aab04-1edd-49d0-bf41-5eceafcda093.html,,oral,LD50,500 mg/kg bw,no adverse effect observed, "(2S,3R,4S,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(hydroxymethyl)-2-methoxytetrahydro-2H-pyran-3,4,5-triol with 2-butyne-1, 4-diol (1:1)",960404-59-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9809a606-cc88-4249-b9ba-700868502fd8/documents/IUC5-5a101384-d456-467a-b3ff-ccf2d3267200_049aab04-1edd-49d0-bf41-5eceafcda093.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "[(2R,3R,4S,5R,6R)-6-bromo-3,4,5-tris(2,2-dimethylpropanoyloxy)oxan-2-yl]methyl 2,2-dimethylpropanoate",81058-27-7,"Repeated dose toxicity - oral: In a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test performed according to the OECD Guideline 422 ted dose and US EPA OPPTS 870.3650, no adverse parental effects were observed up to the highest dose level tested (750 mg/kg) (van Otterdijk, 2018). The following parental NOAEL was derived 750 mg/kg bw/day. In a 90-day repeated dose toxicity study performed according to OECD 408 guidelines, no test item-related effects were observed up to the highest tested dose level (1000 mg/kg bw/day). The NOAEL was considered to be at least 1000 mg/kg/day (Lourens, 2022).  Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP-compliant study, performed according to OECD guideline ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/916ad645-6d84-4621-b9d7-c8db3010f524/documents/b295ed5d-3975-4b2b-b243-e1dead7821c7_41bb7969-2812-4cec-a776-ed0bf804f91c.html,,,,,, "[(2R,3R,4S,5R,6R)-6-bromo-3,4,5-tris(2,2-dimethylpropanoyloxy)oxan-2-yl]methyl 2,2-dimethylpropanoate",81058-27-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/916ad645-6d84-4621-b9d7-c8db3010f524/documents/b295ed5d-3975-4b2b-b243-e1dead7821c7_41bb7969-2812-4cec-a776-ed0bf804f91c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "[(2R,3R,4S,5R,6R)-6-bromo-3,4,5-tris(2,2-dimethylpropanoyloxy)oxan-2-yl]methyl 2,2-dimethylpropanoate",81058-27-7," Acute oral toxicity: In an acute oral toxicity study in female Wistar rats, following the acute toxic class method in accordance with the OECD Guideline 423 and EU Method B.1 tris, the LD50 was established to be greater than 2000 mg/kg (Latour, 2016). Acute inhalation toxicity: In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For T003421, a study was considered however not deemed scientifically justified for the dermal route of exposure due to its low potential for a significant rate of absorption through the skin. Based on the fact that the inhalation route of exposure is not considered relevant in the risk assessment for human exposure and the addition of a waiver for the acute dermal toxicity testing, an acute inhalation toxicity study will not be performed. Acute dermal toxicity In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For this substance, an acute dermal toxicity study was considered. However, this can be waived based on the fact that the substance does not meet the criteria for classification for acute toxicity or STOT SE by the oral route, and no systemic toxicity is observed in in vivo studies with dermal exposure. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/916ad645-6d84-4621-b9d7-c8db3010f524/documents/b26a3cb8-b837-44b1-ad2e-30da4ebd424d_41bb7969-2812-4cec-a776-ed0bf804f91c.html,,,,,, "[(2R,3R,4S,5R,6R)-6-bromo-3,4,5-tris(2,2-dimethylpropanoyloxy)oxan-2-yl]methyl 2,2-dimethylpropanoate",81058-27-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/916ad645-6d84-4621-b9d7-c8db3010f524/documents/b26a3cb8-b837-44b1-ad2e-30da4ebd424d_41bb7969-2812-4cec-a776-ed0bf804f91c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, [(±)-(4-amino-2-hydroxy-4-oxobutyl)trimethylammonium] chloride,5261-99-4,"Key study: OECD guideline. GLP study.A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test in the Rat study was conducted according to OECD guideline 422. Under the conditions of this study, the no observed adverse effect level (NOAEL) for the test substance for parental/adult and F1 effects is considered to be 1000 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b03902cb-d447-45e7-b476-1ffcca257271/documents/IUC5-ee0ae78f-b338-40e6-aa5e-c72b8af3a58d_91abbeec-7948-4092-bf86-668d948b5f73.html,,,,,, [(±)-(4-amino-2-hydroxy-4-oxobutyl)trimethylammonium] chloride,5261-99-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b03902cb-d447-45e7-b476-1ffcca257271/documents/IUC5-ee0ae78f-b338-40e6-aa5e-c72b8af3a58d_91abbeec-7948-4092-bf86-668d948b5f73.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat [(±)-(4-amino-2-hydroxy-4-oxobutyl)trimethylammonium] chloride,5261-99-4,Key study: Acute oral toxicity. OECD guideline and EU method. GLP study.The oral LD50 for the test substance was greater than 2000 mg/kg bw.Key study: Acute dermal toxicity. OECD guideline and EU method. GLP study.The dermal LD50 for the test substance was greater than 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b03902cb-d447-45e7-b476-1ffcca257271/documents/IUC5-6c5b0127-7637-4b4c-b70e-eb9a654aaeac_91abbeec-7948-4092-bf86-668d948b5f73.html,,,,,, [(±)-(4-amino-2-hydroxy-4-oxobutyl)trimethylammonium] chloride,5261-99-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b03902cb-d447-45e7-b476-1ffcca257271/documents/IUC5-6c5b0127-7637-4b4c-b70e-eb9a654aaeac_91abbeec-7948-4092-bf86-668d948b5f73.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, [(±)-(4-amino-2-hydroxy-4-oxobutyl)trimethylammonium] chloride,5261-99-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b03902cb-d447-45e7-b476-1ffcca257271/documents/IUC5-6c5b0127-7637-4b4c-b70e-eb9a654aaeac_91abbeec-7948-4092-bf86-668d948b5f73.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "[(2,4-dibromophenoxy)methyl]oxirane",20217-01-0, one Guideline study on acute oral toxicity available. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5b8cd3b-dd31-41d5-88ea-63abc7758ba1/documents/14a42025-63c8-4b45-99ca-0934d1decf53_1c53d283-075c-49d8-9b17-8e3d79e2aa73.html,,,,,, "[(2,4-dibromophenoxy)methyl]oxirane",20217-01-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5b8cd3b-dd31-41d5-88ea-63abc7758ba1/documents/14a42025-63c8-4b45-99ca-0934d1decf53_1c53d283-075c-49d8-9b17-8e3d79e2aa73.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, [(2-chlorophenyl)methylene]malononitrile,2698-41-1, Lowest LD50 is obtained in female rabbits is 143 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e8c0d3c-b492-46f3-9331-5445875e5314/documents/c428a422-6909-4e07-9eb3-a77639c5ecb3_920bd600-d906-4499-bf94-3c5d077834e3.html,,,,,, [(2-chlorophenyl)methylene]malononitrile,2698-41-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e8c0d3c-b492-46f3-9331-5445875e5314/documents/c428a422-6909-4e07-9eb3-a77639c5ecb3_920bd600-d906-4499-bf94-3c5d077834e3.html,,oral,LD50,143 mg/kg bw,adverse effect observed, [(2-chlorophenyl)methylene]malononitrile,2698-41-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e8c0d3c-b492-46f3-9331-5445875e5314/documents/c428a422-6909-4e07-9eb3-a77639c5ecb3_920bd600-d906-4499-bf94-3c5d077834e3.html,,inhalation,LC50,"50,010 mg/m3",adverse effect observed, "[(8R,9S,10R,13S,14S,17R)-3-ethoxy-17-ethynyl-13-methyl-2,7,8,9,10,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] acetate",50717-99-2," Based on the reliable acute oral toxicity study with a structural analogue Norethyl, Norethylac is not acutely toxic by oral route (LD50 > 2000 mg/kg bw). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/449a50bc-99f0-4b2c-8580-c4312834812d/documents/3df7c3a5-1f56-439d-852a-ec51abb43a6f_89d8d372-7609-4a49-bab6-082be682601b.html,,,,,, "[(8R,9S,10R,13S,14S,17R)-3-ethoxy-17-ethynyl-13-methyl-2,7,8,9,10,11,12,14,15,16-decahydro-1H-cyclopenta[a]phenanthren-17-yl] acetate",50717-99-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/449a50bc-99f0-4b2c-8580-c4312834812d/documents/3df7c3a5-1f56-439d-852a-ec51abb43a6f_89d8d372-7609-4a49-bab6-082be682601b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, [(dimethylamino)methyl]phenol,25338-55-0, The endpoint oral acute toxicity was waived because the substance is classified to be corrosive to the skin (Cat. 1C). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1b69ad9-8c66-4fa4-a6cd-a896a67a53ca/documents/e3a61ead-cfa2-4b3a-a70f-2f823fbd3ed1_47f9eb23-cb8e-4654-ad60-47ea749fa190.html,,,,,, [(o-methoxyphenoxy)methyl]oxirane,2210-74-4,"The acute dermal toxicity in rat was performed following the OECD guidelines no.402 (Acute Dermal Toxicity"" (adopted 24 February 1987) and the Method B.3 Acute Toxicity (Dermal) of Commission Regulation (EC) no.440/2008.The acute oral toxicity in rat - fixed dose method was performed following the OECD guidelines no.420 (Acute Oral Toxicity - Fixed Dose Method"" (adopted 17 December 2001) and the Method B.1 bis Acute Toxicity (Oral) of Commission Regulation (EC) no.440/2008. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/139f3db7-0c3d-4523-9468-ce4c84a7c39c/documents/IUC5-f5c2c3aa-4349-42cb-a95c-6370647a02d4_49793aec-c3ad-4e3c-94d9-d0aa8753c658.html,,,,,, [[(2-ethylhexyl)oxy]methyl]oxirane,2461-15-6,"Based on the study results with of oxirane, 2-((C12-14-alkyloxy)methyl)derivs), the no-observed-effect level (NOEL) of systemic toxicity was 100 mg/kg bw/day in a sub-chronic repeated dose study by dermal application. There was no exposure-related mortality and no effects on body weight, weight gain or food consumption. Haematology, clinical chemistry, and urinalyses results also failed to reveal any differences between control and test animals. There were no gross or histopathological alterations attributed to test item. As justified, this information can be read-across to 2-ethylhexyl glycidyl ether, considering the similarities and similar properties of the two substances. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75385712-cda8-46c1-8819-b5a382cf26b1/documents/8d485883-a669-4c87-9bbd-6e5527b85f96_63d1531e-57cc-4b36-a704-109726985832.html,,,,,, [[(2-ethylhexyl)oxy]methyl]oxirane,2461-15-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75385712-cda8-46c1-8819-b5a382cf26b1/documents/8d485883-a669-4c87-9bbd-6e5527b85f96_63d1531e-57cc-4b36-a704-109726985832.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,,rat [[(2-ethylhexyl)oxy]methyl]oxirane,2461-15-6,"LD50(oral, rat, 24h): >5000 mg/kg bw;LD0(dermal, rabbit, 72h): >4000mg/kg bwLC50(inhalation, rat, 7h): >0.15 mg/L ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75385712-cda8-46c1-8819-b5a382cf26b1/documents/1fa9b207-f066-48a4-9d75-c0fece2f2979_63d1531e-57cc-4b36-a704-109726985832.html,,,,,, [[(2-ethylhexyl)oxy]methyl]oxirane,2461-15-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75385712-cda8-46c1-8819-b5a382cf26b1/documents/1fa9b207-f066-48a4-9d75-c0fece2f2979_63d1531e-57cc-4b36-a704-109726985832.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, [[(2-ethylhexyl)oxy]methyl]oxirane,2461-15-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75385712-cda8-46c1-8819-b5a382cf26b1/documents/1fa9b207-f066-48a4-9d75-c0fece2f2979_63d1531e-57cc-4b36-a704-109726985832.html,,dermal,LD50,"> 4,000 mg/kg bw",no adverse effect observed, [[(2-ethylhexyl)oxy]methyl]oxirane,2461-15-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75385712-cda8-46c1-8819-b5a382cf26b1/documents/1fa9b207-f066-48a4-9d75-c0fece2f2979_63d1531e-57cc-4b36-a704-109726985832.html,,inhalation,LC0,> 0.15 mg/L,no adverse effect observed, "[[(phosphonomethyl)imino]bis[ethylenenitrilobis(methylene)]]tetrakisphosphonic acid, ammonium salt",70714-66-8," There are no repeated dose toxicity data for the ammonium salts of DTPMP. Therefore data have been read across from sodium salts of DTPMP.   In the key 90-day oral (feeding) repeated dose toxicity study, conducted according to OECD Test Guideline 408 and in compliance with GLP, the NOAEL for DTPMP-xNa was concluded to be 1000 ppm (equivalent to 82.5 and 92.3 mg/kg bw/day of active acid in males and females, respectively; the test material contained 46.9% w/w active acid; according to the study report the administered test substance was corrected for purity) (Central Toxicology Laboratory, 1998). The NOAEL was based on minor changes in haematological parameters (red blood cell count was significantly increased, mean cell volume and mean cell haemoglobin concentration were significantly decreased) were noted at the highest dose tested. There was also a decreased incidence in Perls' staining of the spleen. Bone density was significantly increased in both sexes in the highest dose group, and the incidence of microlithiasis in the kidney was reduced at all dose levels. These changes are indicative of the influence of DTPMPxNa on calcium homeostasis, however, without causing any changes in calcium plasma levels. There are no available toxicity data for inhalation or dermal routes. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d647a9a1-9b34-4c72-9ac1-55a781eab7e0/documents/7e8482a0-c468-4329-a49c-a35a72f6031d_d7327012-335d-411a-b70e-6fd54b5cc2f0.html,,,,,, "[[(phosphonomethyl)imino]bis[ethylenenitrilobis(methylene)]]tetrakisphosphonic acid, ammonium salt",70714-66-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d647a9a1-9b34-4c72-9ac1-55a781eab7e0/documents/7e8482a0-c468-4329-a49c-a35a72f6031d_d7327012-335d-411a-b70e-6fd54b5cc2f0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,82.5 mg/kg bw/day,,rat "[[(phosphonomethyl)imino]bis[ethylenenitrilobis(methylene)]]tetrakisphosphonic acid, ammonium salt",70714-66-8," There are no acute toxicity data for the ammonium salt of DTPMP. Therefore data from DTPMP-H and sodium salts of DTPMP have been used in a weight of evidence approach.   In an acute oral toxicity study with DTPMP-7Na, conducted according to a protocol comparable to the now-deleted OECD Test Guideline 401 and in compliance with GLP, the LD50 for DTPMP-7Na was ≥10 ml/kg bw in rats (equivalent to ≥5838 mg active salt/kg bw and ≥4612 mg active acid/kg bw) (SafePharm Laboratories, 1982a). In an acute oral toxicity study with DTPMP-7Na, conducted according to a protocol comparable to the now-deleted OECD Test Guideline 401 and in compliance with GLP, the LD50 for DTPMP-7Na was <15 ml/kg bw (equivalent to <8757 mg active salt/kg and 6918 mg active acid/kg bw) in the rat (SafePharm Laboratories, 1982b). In an acute dermal toxicity study with DTPMP-7Na, conducted according to a protocol comparable to OECD Test Guideline 402 and according to GLP, the LD50 for DTPMP-7Na was ≥10 ml/kg bw (equivalent to 5838 mg active salt/kg bw and 4612 mg active acid/kg bw) in rats (SafePharm Laboratories, 1982c; reliability score 1). In an acute dermal toxicity study (Younger Laboratories, 1971), 58% w/w solution of DTPMP-H was applied to the clipped, intact skin of four New Zealand white rabbits, under an occlusive dressing, for 24 hours. Animals were then observed for 14 days, and all animals were examined macroscopically. No animals died and the LD50 was concluded to be greater than 7940 mg/kg bw (equivalent to >4605 mg active acid/kg bw). Clinical signs included reduced appetite and activity for one to two days after treatment. There were no abnormal macroscopic findings. There are no inhalation data. The study meets generally accepted scientific principles, but pre-dated GLP. There are no data for the inhalation route. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d647a9a1-9b34-4c72-9ac1-55a781eab7e0/documents/6e501906-9890-4595-a5f7-347646b770eb_d7327012-335d-411a-b70e-6fd54b5cc2f0.html,,,,,, "[[(phosphonomethyl)imino]bis[ethylenenitrilobis(methylene)]]tetrakisphosphonic acid, ammonium salt",70714-66-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d647a9a1-9b34-4c72-9ac1-55a781eab7e0/documents/6e501906-9890-4595-a5f7-347646b770eb_d7327012-335d-411a-b70e-6fd54b5cc2f0.html,,oral,LD50,"4,612 mg/kg bw",adverse effect observed, "[[(phosphonomethyl)imino]bis[ethylenenitrilobis(methylene)]]tetrakisphosphonic acid, ammonium salt",70714-66-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d647a9a1-9b34-4c72-9ac1-55a781eab7e0/documents/6e501906-9890-4595-a5f7-347646b770eb_d7327012-335d-411a-b70e-6fd54b5cc2f0.html,,dermal,LD50,"4,605 mg/kg bw",no adverse effect observed, "[[(phosphonomethyl)imino]bis[ethylenenitrilobis(methylene)]]tetrakisphosphonic acid, potassium salt",84852-49-3,"There are no data for the potassium salts of DTPMP. Therefore data have been read across from sodium salts of DTPMP. In a good quality 90-day feeding study (CTL, 1998) conducted to OECD 408 and GLP, groups of 12 male and 12 female Wistar-derived rats were fed diets containing 0 (control), 100, 1000 or 10000 ppm (equivalent to 8.2, 82.5 and 841.9 mg/kg bw/day in males and 9.2, 92.3 and 902.6 mg/kg for females) Dequest 2066A (sodium salt of DTPMP) for 90 consecutive days. There were no deaths and the majority of parameters were unaffected by the treatment. Minor changes in certain haematological parameters (red blood cell count was significantly increased, mean cell volume and mean cell haemoglobin concentration were significantly decreased) were noted at the highest dose. There was also a decreased incidence in Perls' staining of the spleen. Bone density was significantly increased in both sexes in the highest dose group, and the incidence of microlithiasis in the kidney was reduced at all dose levels. These changes are indicative of the influence of Dequest 2066A on calcium homeostasis, however, without causing any changes in calcium plasma levels. Therefore, the changes were not considered to be of toxicological significance, and the NOAEL was 10000 ppm (equivalent to to 841.9 and 902.6 mg/kg bw/day of the salt in males and female, respectively).However, it is the opinion of the author of this study summary that anaemia in humans is of concern, and therefore the NOAEL is reduced to 1000 ppm (equivalent to 82.5 and 92.3 mg/kg bw/day for males and females, respectively). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d30f5e78-9603-444e-b479-2c3ed432b1a6/documents/IUC5-18d0cd17-ca45-4cac-9263-d811ce349ed2_1a0fb7ad-0027-4e48-9c69-6a8d83998f2f.html,,,,,, "[[(phosphonomethyl)imino]bis[ethylenenitrilobis(methylene)]]tetrakisphosphonic acid, potassium salt",84852-49-3,"There are no acute toxicity data for the potassium salts of DTPMP. Therefore data from the sodium salts have been read across. In a well conducted acute oral toxicity study (Safepharm Laboratories, 1982) carried out using a protocol comparable to the now deleted OECD 401, and to GLP, the LD50 for the sodium salt of DTPMP was >10 ml/kg bw in rats (>5838 mg active salt/kg bw, equivalent to >4602 mg parent acid).In an acute dermal toxicity study (Safepharm Laboratories, 1982) conducted using a protocol comparable to OECD 402, and to GLP, the LD50 for the sodium salt of DTPMP was >10 ml/kg bw (>5838 mg active salt/kg bw, equivalent to >4602 mg parent acid) in rats. There are no data for the inhalation route. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d30f5e78-9603-444e-b479-2c3ed432b1a6/documents/IUC5-f34e3a39-edf2-4641-8508-680a63b422e5_1a0fb7ad-0027-4e48-9c69-6a8d83998f2f.html,,,,,, [[(phosphonomethyl)imino]bis[hexamethylenenitrilobis(methylene)]]tetrakisphosphonic acid,34690-00-1," There are no data available for the registered substance BHMT-H. Therefore, data are read-across from the structural analogue DTPMP-xNa. In a good quality 90-day repeated dose toxicity study (CTL, 1998), conducted according to OECD Test Guideline 408 and in compliance with GLP, groups of 12 male and 12 female Wistar-derived rats were fed diets containing 0 (control), 100, 1000 or 10000 ppm (equivalent to 8.2, 82.5 and 841.9 mg/kg bw/day in males and 9.2, 92.3 and 902.6 mg/kg for females) test material (sodium salt of DTPMP, xNa, 46.9% w/w total active acid) for 90 consecutive days. There were no deaths and the majority of parameters were unaffected by the treatment. Minor changes in certain haematological parameters (red blood cell count was significantly increased, mean cell volume and mean cell haemoglobin concentration were significantly decreased) were noted at the highest dose. There was also a decreased incidence in Perls' staining of the spleen. Bone density was significantly increased in both sexes in the highest dose group, and the incidence of microlithiasis in the kidney was reduced at all dose levels. These changes are indicative of the influence of the test material on calcium homeostasis, however, without causing any changes in calcium plasma levels. Therefore, the changes were not considered to be of toxicological significance, and the NOAEL was concluded to be 10000 ppm (equivalent to to 841.9 and 902.6 mg/kg bw/day of the salt in males and female, respectively). However, it is the opinion of the author of this study summary that anaemia in humans is of concern, and therefore the NOAEL is reduced to 1000 ppm (equivalent to 82.5 and 92.3 mg active acid/kg bw/day for males and females, respectively). The test material contained 46.9% active acid. According to the study report the administered test substance had been corrected for purity. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/23e31799-565a-4085-af36-2c1f6b87a2e7/documents/f3bc9a8e-5303-4265-8626-1c83a1dd894a_e4e4374e-547c-4609-a2c5-863c23bb183b.html,,,,,, [[(phosphonomethyl)imino]bis[hexamethylenenitrilobis(methylene)]]tetrakisphosphonic acid,34690-00-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/23e31799-565a-4085-af36-2c1f6b87a2e7/documents/f3bc9a8e-5303-4265-8626-1c83a1dd894a_e4e4374e-547c-4609-a2c5-863c23bb183b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,82.5 mg/kg bw/day,,rat [[(phosphonomethyl)imino]bis[hexamethylenenitrilobis(methylene)]]tetrakisphosphonic acid,34690-00-1," There are no acute toxicity data available for BHMT-H. Therefore, data are read across from the structural analogue DTPMP-H (CAS 15827-60-8). In the acute oral toxicity study for DTPMP-H (Younger Laboratories, 1971a), conducted according to a protocol similar to the now-deleted OECD Test Guideline 401, but conducted prior to GLP, the LD50 was concluded to be 7180 mg/kg bw (equivalent to 4164 mg active acid/kg bw). In the acute dermal toxicity study for DTPMP-H (Younger Laboratories, 1971b), conducted according to a protocol similar to OECD Test Guideline 402, but conducted prior to GLP, the LD50 was concluded to be greater than 7940 mg/kg bw (equivalent to >4605 mg active acid/kg bw). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23e31799-565a-4085-af36-2c1f6b87a2e7/documents/1d7ecad3-ed0e-4ded-a33b-0f97a2eb4bcc_e4e4374e-547c-4609-a2c5-863c23bb183b.html,,,,,, [[(phosphonomethyl)imino]bis[hexamethylenenitrilobis(methylene)]]tetrakisphosphonic acid,34690-00-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23e31799-565a-4085-af36-2c1f6b87a2e7/documents/1d7ecad3-ed0e-4ded-a33b-0f97a2eb4bcc_e4e4374e-547c-4609-a2c5-863c23bb183b.html,,oral,LD50,"4,164 mg/kg bw",no adverse effect observed, [[(phosphonomethyl)imino]bis[hexamethylenenitrilobis(methylene)]]tetrakisphosphonic acid,34690-00-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23e31799-565a-4085-af36-2c1f6b87a2e7/documents/1d7ecad3-ed0e-4ded-a33b-0f97a2eb4bcc_e4e4374e-547c-4609-a2c5-863c23bb183b.html,,dermal,LD50,"4,605 mg/kg bw",no adverse effect observed, "[[2,2',2''-[29H,31H-phthalocyaninetriyltris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)-N29,N30,N31,N32]copper",59160-79-1," A 14-day study in rats with 300 and 1000 mg/kg bw of the substance showed absence of toxicity. No indication of systemic uptake as determined via serum copper concentrations was observed. For support, data on the smaller copper phthalocyanine core (CAS 147-15-8) is used. It shows lack of effects in rats and mice upon subchronic feed exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ecb7b2e2-8ac9-4ec3-92bc-4207db71a1d5/documents/IUC5-dc3accc6-e914-4f39-9e3e-c250892ddf30_5a72778c-742d-4796-a35e-15dee1b89220.html,,,,,, "[[2,2',2''-[29H,31H-phthalocyaninetriyltris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)-N29,N30,N31,N32]copper",59160-79-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ecb7b2e2-8ac9-4ec3-92bc-4207db71a1d5/documents/IUC5-dc3accc6-e914-4f39-9e3e-c250892ddf30_5a72778c-742d-4796-a35e-15dee1b89220.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "[[2,2',2''-[29H,31H-phthalocyaninetriyltris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)-N29,N30,N31,N32]copper",59160-79-1,The study is practically non-toxic in rats after single ingestion and dermal application. An inhalation study performed with poorly characterized dust did not show acute inhalation toxicity. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecb7b2e2-8ac9-4ec3-92bc-4207db71a1d5/documents/IUC5-22bf79ab-fb1f-47cc-844f-6933cccec38c_5a72778c-742d-4796-a35e-15dee1b89220.html,,,,,, "[[2,2',2''-[29H,31H-phthalocyaninetriyltris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)-N29,N30,N31,N32]copper",59160-79-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecb7b2e2-8ac9-4ec3-92bc-4207db71a1d5/documents/IUC5-22bf79ab-fb1f-47cc-844f-6933cccec38c_5a72778c-742d-4796-a35e-15dee1b89220.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "[[2,2',2''-[29H,31H-phthalocyaninetriyltris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)-N29,N30,N31,N32]copper",59160-79-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecb7b2e2-8ac9-4ec3-92bc-4207db71a1d5/documents/IUC5-22bf79ab-fb1f-47cc-844f-6933cccec38c_5a72778c-742d-4796-a35e-15dee1b89220.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "[[2,2',2''-[29H,31H-phthalocyaninetriyltris(methylene)]tris[1H-isoindole-1,3(2H)-dionato]](2-)-N29,N30,N31,N32]copper",59160-79-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecb7b2e2-8ac9-4ec3-92bc-4207db71a1d5/documents/IUC5-22bf79ab-fb1f-47cc-844f-6933cccec38c_5a72778c-742d-4796-a35e-15dee1b89220.html,,inhalation,LC50,> 5 mg/m3,no adverse effect observed, [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile,54079-53-7," Repeated dose toxicity: Oral The No Observed Adverse Effect Level (NOAEL) for the test chemical in Sprague Dawley Rats, via oral gavage, for 28 days with two weeks recovery period was found to be 1000 mg/kg bw/day. Repeated inhalation study: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile (54079-53-7) which is reported as 0.02302689mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile . Therefore this study is considered for waiver. Repeated dermal study; The acute toxicity value for [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile (54079-53-7) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that for [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that for [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/539494f9-452e-4d2b-b3af-c1651d21749e/documents/9f4a0a80-7ad5-4383-b3c1-ea81be3af17c_ca0d01ee-fb94-46f8-b7b4-76f5d2ee6aa3.html,,,,,, [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile,54079-53-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/539494f9-452e-4d2b-b3af-c1651d21749e/documents/9f4a0a80-7ad5-4383-b3c1-ea81be3af17c_ca0d01ee-fb94-46f8-b7b4-76f5d2ee6aa3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile,54079-53-7," Acute oral toxicity:  Acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the given test chemical. The LD50 value was considered is >5000 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  The acute toxicity inhalation study need not be conducted because exposure to humans via inhalation route is not likely taking into account the low vapour pressure of the substance, which is reported as 3.07E-010 Pa. Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely. Therefore this study is considered for waiver.   Acute Dermal toxicity:  The acute dermal toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/539494f9-452e-4d2b-b3af-c1651d21749e/documents/5dd63cac-07bc-4034-a76a-154202f4d0df_ca0d01ee-fb94-46f8-b7b4-76f5d2ee6aa3.html,,,,,, [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile,54079-53-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/539494f9-452e-4d2b-b3af-c1651d21749e/documents/5dd63cac-07bc-4034-a76a-154202f4d0df_ca0d01ee-fb94-46f8-b7b4-76f5d2ee6aa3.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, [[4-[[2-(4-cyclohexylphenoxy)ethyl]ethylamino]-2-methylphenyl]methylene]malononitrile,54079-53-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/539494f9-452e-4d2b-b3af-c1651d21749e/documents/5dd63cac-07bc-4034-a76a-154202f4d0df_ca0d01ee-fb94-46f8-b7b4-76f5d2ee6aa3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "[[4-[[4-(anilino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]benzenesulphonic acid",1324-76-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): guideline test with GLP ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df3a765a-7137-49b3-abd3-92263034f8ef/documents/7fd66fdd-b674-4c42-b0b5-855ef67feea8_209aca91-9201-475a-b735-4ce93a79d960.html,,,,,, "[[4-[[4-(anilino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]benzenesulphonic acid",1324-76-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df3a765a-7137-49b3-abd3-92263034f8ef/documents/7fd66fdd-b674-4c42-b0b5-855ef67feea8_209aca91-9201-475a-b735-4ce93a79d960.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "[[4-[[4-(anilino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]benzenesulphonic acid",1324-76-1,"In two acute oral toxicity studies no deaths occured up to the highest dose of 5000 mg/kg bw. There were no adverse effects observed in the body weight gain, clinical signs and gross pathology. The LD50 is therefore greater than 5000 mg/kg bw.   In six non-GLP dermal tests in rabbits, no deaths occured at the single doser of 2000 mg/kg bw, nore were there signs of toxicity during the exposure or the 14 days post-exposure observation preiod. The LD50 is therefore greater than 2000 mg/kg bw.   Rats being exposed to an aerosol of the test article at an actual concentration of 2.48 milligrams per liter of air were held for 14 days post-exposure for observations of latent effects. There were no deaths or signs of toxicity during the exposure or the fourteen day observation period. Therefore, one hour LC50 for test article is estimated to be greater than 2480 mg/m³.     ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df3a765a-7137-49b3-abd3-92263034f8ef/documents/48927339-5949-4062-bf24-8a184e631726_209aca91-9201-475a-b735-4ce93a79d960.html,,,,,, "[[4-[[4-(anilino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]benzenesulphonic acid",1324-76-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df3a765a-7137-49b3-abd3-92263034f8ef/documents/48927339-5949-4062-bf24-8a184e631726_209aca91-9201-475a-b735-4ce93a79d960.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "[[4-[[4-(anilino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]benzenesulphonic acid",1324-76-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df3a765a-7137-49b3-abd3-92263034f8ef/documents/48927339-5949-4062-bf24-8a184e631726_209aca91-9201-475a-b735-4ce93a79d960.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "[[4-[[4-(anilino)phenyl][4-(phenylimino)-2,5-cyclohexadien-1-ylidene]methyl]phenyl]amino]benzenesulphonic acid",1324-76-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df3a765a-7137-49b3-abd3-92263034f8ef/documents/48927339-5949-4062-bf24-8a184e631726_209aca91-9201-475a-b735-4ce93a79d960.html,,inhalation,LC50,"> 2,480 mg/m3",no adverse effect observed, "3-phenyl-5-(1,1,1-trifluoro-2-{6-hydroxy-5-phenyl-[1,1'-biphenyl]-3-yl}propan-2-yl)-[1,1'-biphenyl]-2-ol",43100-47-6,Oral repeated dose administration did not lead to adverse effects in OECD TG 422 study. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9353d7c-b8b8-4844-9f4d-2f2b3f094ed2/documents/IUC5-f0e7556a-27ca-4f65-904e-d65d0d69e160_f7ce801d-5081-4d01-8d23-0d6b8dc0c482.html,,,,,, "3-phenyl-5-(1,1,1-trifluoro-2-{6-hydroxy-5-phenyl-[1,1'-biphenyl]-3-yl}propan-2-yl)-[1,1'-biphenyl]-2-ol",43100-47-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9353d7c-b8b8-4844-9f4d-2f2b3f094ed2/documents/IUC5-f0e7556a-27ca-4f65-904e-d65d0d69e160_f7ce801d-5081-4d01-8d23-0d6b8dc0c482.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3-phenyl-5-(1,1,1-trifluoro-2-{6-hydroxy-5-phenyl-[1,1'-biphenyl]-3-yl}propan-2-yl)-[1,1'-biphenyl]-2-ol",43100-47-6,"OECD 423: LD50 (oral) > 2000 mg/kg bw (BASF SE, 2008)OECD 402: LD50 (dermal) > 2000 mg/kg bw (BASF SE, 2015) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9353d7c-b8b8-4844-9f4d-2f2b3f094ed2/documents/IUC5-4828204b-c59a-4aad-be8a-8f2e8028a2e8_f7ce801d-5081-4d01-8d23-0d6b8dc0c482.html,,,,,, "3-phenyl-5-(1,1,1-trifluoro-2-{6-hydroxy-5-phenyl-[1,1'-biphenyl]-3-yl}propan-2-yl)-[1,1'-biphenyl]-2-ol",43100-47-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9353d7c-b8b8-4844-9f4d-2f2b3f094ed2/documents/IUC5-4828204b-c59a-4aad-be8a-8f2e8028a2e8_f7ce801d-5081-4d01-8d23-0d6b8dc0c482.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-phenyl-5-(1,1,1-trifluoro-2-{6-hydroxy-5-phenyl-[1,1'-biphenyl]-3-yl}propan-2-yl)-[1,1'-biphenyl]-2-ol",43100-47-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9353d7c-b8b8-4844-9f4d-2f2b3f094ed2/documents/IUC5-4828204b-c59a-4aad-be8a-8f2e8028a2e8_f7ce801d-5081-4d01-8d23-0d6b8dc0c482.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, methyl 4'-(bromomethyl)biphenyl-2-carboxylate,114772-38-2,Key study: Test method OECD 420. GLP study. The test item did not produce signs of toxicity in rats at the highest dose of 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6088646e-ca8b-4598-8e79-6dfd0ada08da/documents/IUC5-a4c9f998-9fd1-425d-bc16-0013aed7be4f_d3cbeb8d-5a32-4709-b32f-8ca068c8b76b.html,,,,,, methyl 4'-(bromomethyl)biphenyl-2-carboxylate,114772-38-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6088646e-ca8b-4598-8e79-6dfd0ada08da/documents/IUC5-a4c9f998-9fd1-425d-bc16-0013aed7be4f_d3cbeb8d-5a32-4709-b32f-8ca068c8b76b.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "[1,3(or 1,4)-phenylenebis(1-methylethylidene)]bis[tert-butyl] peroxide",25155-25-3,The NOAEL for repeated dose toxicity study was established at 200 mg/kg/day in males and females rats considering the adverse effects observed at 800 mg/kg/day on the body weight gain in males and the kidneys in males and females during a 90-day study. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a44fb933-8458-46a2-947d-0023b38ac722/documents/IUC5-42fb3bf3-b6bb-4496-a65c-30368f868902_66c43c5d-82b3-407e-a1de-0fd4cde7b98c.html,,,,,, "[1,3(or 1,4)-phenylenebis(1-methylethylidene)]bis[tert-butyl] peroxide",25155-25-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a44fb933-8458-46a2-947d-0023b38ac722/documents/IUC5-42fb3bf3-b6bb-4496-a65c-30368f868902_66c43c5d-82b3-407e-a1de-0fd4cde7b98c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "[1,3(or 1,4)-phenylenebis(1-methylethylidene)]bis[tert-butyl] peroxide",25155-25-3,"The dermal and oral LD0 of [1,3(or 1,4)-phenylenebis(1-methylethylidene)]bis[tert-butyl] peroxide are more than 2000 mg/kg in Sprague Dawley rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a44fb933-8458-46a2-947d-0023b38ac722/documents/IUC5-33b5649f-a5af-4996-8fc7-7faec23ba814_66c43c5d-82b3-407e-a1de-0fd4cde7b98c.html,,,,,, "[1,3(or 1,4)-phenylenebis(1-methylethylidene)]bis[tert-butyl] peroxide",25155-25-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a44fb933-8458-46a2-947d-0023b38ac722/documents/IUC5-33b5649f-a5af-4996-8fc7-7faec23ba814_66c43c5d-82b3-407e-a1de-0fd4cde7b98c.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "[1,3(or 1,4)-phenylenebis(1-methylethylidene)]bis[tert-butyl] peroxide",25155-25-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a44fb933-8458-46a2-947d-0023b38ac722/documents/IUC5-33b5649f-a5af-4996-8fc7-7faec23ba814_66c43c5d-82b3-407e-a1de-0fd4cde7b98c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "[1,3,8,16,18,24-hexabromo-2,4,9,10,11,15,17,22,23,25-decachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper",14302-13-7,The substance is identified as non hazardous by read-across. ,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a86ccbf8-c89b-4c03-9920-324934f16292/documents/IUC5-b28adc2a-1067-4bfd-9395-9acf4af8f119_b648dae2-f7b8-4ff7-8e30-5829feb49607.html,,,,,, "[1,3,8,16,18,24-hexabromo-2,4,9,10,11,15,17,22,23,25-decachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper",14302-13-7,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a86ccbf8-c89b-4c03-9920-324934f16292/documents/IUC5-b28adc2a-1067-4bfd-9395-9acf4af8f119_b648dae2-f7b8-4ff7-8e30-5829feb49607.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "[1,3,8,16,18,24-hexabromo-2,4,9,10,11,15,17,22,23,25-decachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper",14302-13-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a86ccbf8-c89b-4c03-9920-324934f16292/documents/IUC5-d05d35ed-b28e-495c-9cc0-efb4e6444717_b648dae2-f7b8-4ff7-8e30-5829feb49607.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "[1,3,8,16,18,24-hexabromo-2,4,9,10,11,15,17,22,23,25-decachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper",14302-13-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a86ccbf8-c89b-4c03-9920-324934f16292/documents/IUC5-d05d35ed-b28e-495c-9cc0-efb4e6444717_b648dae2-f7b8-4ff7-8e30-5829feb49607.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "[1,3-dihydro-5,6-bis[[(2-hydroxy-1-naphthyl)methylene]amino]-2H-benzimidazol-2-onato(2-)-N5,N6,O5,O6]nickel",42844-93-9," Oral repeated dose toxicity: An OECD guideline Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test was performed with the test item (C.I. Pigment Orange 68).   The test item was administered to the main groups (10 male and 10 female) by oral gavage at dose levels of 0, 110, 330 and 1000 mg/kg bw/day. Recovery groups (5 male and 5 females) received dose levels of 0 and 1000 mg/kg bw/day. The dose formulations were administered prior to mating, during mating and post-mating periods for males, and prior to mating, during mating, during pregnancy and up to Lactation Day 13 for females. In the control and high dose recovery groups, the treatment period was followed by a 14 day no treatment (recovery) period. Animals in the recovery groups were not mated.   No toxicologically significant changes were noted in any of the parameters investigated in this study (such as clinical signs, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). A No Observed Adverse Effect Level (NOAEL) for the test item for repeated dose toxicity of 1000 mg/kg bw/day was established. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c0c27d5-4efd-41ee-9e43-c6979380199b/documents/afa99104-7e98-40a8-9fbd-01a40e49f563_ef7a4626-3794-4119-8add-413e187cd667.html,,,,,, "[1,3-dihydro-5,6-bis[[(2-hydroxy-1-naphthyl)methylene]amino]-2H-benzimidazol-2-onato(2-)-N5,N6,O5,O6]nickel",42844-93-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c0c27d5-4efd-41ee-9e43-c6979380199b/documents/afa99104-7e98-40a8-9fbd-01a40e49f563_ef7a4626-3794-4119-8add-413e187cd667.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "[1,3-dihydro-5,6-bis[[(2-hydroxy-1-naphthyl)methylene]amino]-2H-benzimidazol-2-onato(2-)-N5,N6,O5,O6]nickel",42844-93-9,"Acute oral toxicity: The test item (C.I. Pigment Orange 68) did not cause any mortality or clinical signs after single oral gavage administration to male female rats at 2000 mg/kg bw in a valid guideline study. Acute inhalation toxicity No mortality occurred when exposed to a test atmosphere concentration of 5.02 mg/L as a maximum achievable concentration for 4 hours. The acute inhalation median lethal concentration (LC50) of PV Fast Orange 6RL in male and female Crl:WI rats was therefore considered to be above 5.02 mg/L Acute dermal toxicity: The substance does not meet the criteria for classification as acutely toxic or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (column II, Annex VIII, 8.5.3, Regulation (EC) 2016/863) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable without restriction Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): reliable ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c0c27d5-4efd-41ee-9e43-c6979380199b/documents/869229d9-76c1-4bbe-9338-37413ee3a52f_ef7a4626-3794-4119-8add-413e187cd667.html,,,,,, "[1,3-dihydro-5,6-bis[[(2-hydroxy-1-naphthyl)methylene]amino]-2H-benzimidazol-2-onato(2-)-N5,N6,O5,O6]nickel",42844-93-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c0c27d5-4efd-41ee-9e43-c6979380199b/documents/869229d9-76c1-4bbe-9338-37413ee3a52f_ef7a4626-3794-4119-8add-413e187cd667.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "[1,3-dihydro-5,6-bis[[(2-hydroxy-1-naphthyl)methylene]amino]-2H-benzimidazol-2-onato(2-)-N5,N6,O5,O6]nickel",42844-93-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c0c27d5-4efd-41ee-9e43-c6979380199b/documents/869229d9-76c1-4bbe-9338-37413ee3a52f_ef7a4626-3794-4119-8add-413e187cd667.html,,inhalation,LC0,5.02 mg/L,no adverse effect observed, "[1,3-phenylenebis(1-methylethylidene)]bis[tert-butyl] peroxide",2212-81-9," For 2212 -81 -9 an OECD 422 is available. Form this study the parental NOAEL is 300 mg/kg bw/day, based on adverse effects on the liver (i.e. hepatocellular necrosis and substantial liver enlargement) and kidneys (i.e. tubular degeneration) at 1000 mg/kg bw/day in both sexes. The key NOAEL for repeated dose toxicity study in the read-across substance 25155 -25 -3, was established at 200 mg/kg/day in males and females rats considering the adverse effects observed at 800 mg/kg/day on the body weight gain in males and the kidneys in males and females during a 90-day study. For further details on the read across rationale see section 13.2. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35966e13-bac1-4947-93c6-4e3e5707a2e9/documents/IUC5-f8daae59-0f78-4454-ba94-a90f5c8b92ce_81cef154-2670-4125-af48-b2e31419d419.html,,,,,, "[1,3-phenylenebis(1-methylethylidene)]bis[tert-butyl] peroxide",2212-81-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35966e13-bac1-4947-93c6-4e3e5707a2e9/documents/IUC5-f8daae59-0f78-4454-ba94-a90f5c8b92ce_81cef154-2670-4125-af48-b2e31419d419.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "[1,3-phenylenebis(1-methylethylidene)]bis[tert-butyl] peroxide",2212-81-9," The dermal and oral LD0 of structurally analogous [1,3(or 1,4)-phenylenebis(1-methylethylidene)]bis[tert-butyl] peroxide are more than 2000 mg/kg in Sprague Dawley rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35966e13-bac1-4947-93c6-4e3e5707a2e9/documents/IUC5-dd775e7f-5c4d-4d8a-977a-3c5b2c840e5e_81cef154-2670-4125-af48-b2e31419d419.html,,,,,, "[1,3-phenylenebis(1-methylethylidene)]bis[tert-butyl] peroxide",2212-81-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35966e13-bac1-4947-93c6-4e3e5707a2e9/documents/IUC5-dd775e7f-5c4d-4d8a-977a-3c5b2c840e5e_81cef154-2670-4125-af48-b2e31419d419.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "[1,3-phenylenebis(1-methylethylidene)]bis[tert-butyl] peroxide",2212-81-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35966e13-bac1-4947-93c6-4e3e5707a2e9/documents/IUC5-dd775e7f-5c4d-4d8a-977a-3c5b2c840e5e_81cef154-2670-4125-af48-b2e31419d419.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "[1-[[(2-hydroxyphenyl)imino]methyl]-2-naphtholato(2-)-N,O,O']copper",15680-42-9, The substance is an organic copper complex that disintegrates at least partly in the acidic environment of the stomach. Subacute gavage dosing causes adverse effects on liver at doses of 300 and 1000 mg/kg bw. The hazard pattern is characteristic of copper toxicity. The study was performed according to OECD guideline and under GLP. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/59958398-7095-4c0a-8f74-b7d0079dc63e/documents/IUC5-3293c22f-9614-4601-a9fe-e582f68c3638_3f737320-c5f3-43da-a1e3-49fcd509c374.html,,,,,, "[1-[[(2-hydroxyphenyl)imino]methyl]-2-naphtholato(2-)-N,O,O']copper",15680-42-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/59958398-7095-4c0a-8f74-b7d0079dc63e/documents/IUC5-3293c22f-9614-4601-a9fe-e582f68c3638_3f737320-c5f3-43da-a1e3-49fcd509c374.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "[1-[[(2-hydroxyphenyl)imino]methyl]-2-naphtholato(2-)-N,O,O']copper",15680-42-9," No mortality upon single gavage doses of 5000 and 10000 mg/kg bw was observed in rats. Both studies were performed prior to the introduction of GLP and OECD guidelines, but were performed in a very similar design.   Dust inhalation caused mortality in the LC50range of 1- 4 mg/L. Two studies are available. A 4h-study performed around 1980 performed with a poorly characterized test material an LC50of 1825 mg/m3. A GLP and OECD 403 guideline conform study with the nanomaterial performed in 2014 showed that rats survive a 4h exposure to 0.97 mg/L, but not to 4.1 mg/L. These findings are consistent with the LC50 calculated from the older study. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59958398-7095-4c0a-8f74-b7d0079dc63e/documents/IUC5-d8d9b7bc-6a0b-4437-ab5d-4cbb6cc5d1b7_3f737320-c5f3-43da-a1e3-49fcd509c374.html,,,,,, "[1-[[(2-hydroxyphenyl)imino]methyl]-2-naphtholato(2-)-N,O,O']copper",15680-42-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59958398-7095-4c0a-8f74-b7d0079dc63e/documents/IUC5-d8d9b7bc-6a0b-4437-ab5d-4cbb6cc5d1b7_3f737320-c5f3-43da-a1e3-49fcd509c374.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "[1-[[(2-hydroxyphenyl)imino]methyl]-2-naphtholato(2-)-N,O,O']copper",15680-42-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59958398-7095-4c0a-8f74-b7d0079dc63e/documents/IUC5-d8d9b7bc-6a0b-4437-ab5d-4cbb6cc5d1b7_3f737320-c5f3-43da-a1e3-49fcd509c374.html,,inhalation,LC50,"1,825 mg/m3",adverse effect observed, "[1R-(1α,2β,5α)]-1-(isopropyl)-2-methoxy-4-methylcyclohexane",1565-76-0,"Oral (OECD 423), rat: LD50 > 2000 mg/kg bw (limit test); The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6abf380-c32b-4e1a-afd1-935029c93c2b/documents/260c276f-d9a5-4980-b702-106716b1e698_27122e51-654e-4d6d-8d92-980bb9e2ebfa.html,,,,,, "[1S-(1α,2β,3α,5α)]-[2,6,6-trimethylbicyclo[3.1.1]hept-3-yl]methylamine",57357-85-4," In a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to OECD Guideline 422, the NOAEL (no observed adverse effect level) for general, systemic toxicity of (+)-3-Aminomethylpinan was the mid dose of 25 mg/kg bw/d. At the highest tested dose of 75 mg/kg bw/d, treatment-related adverse effects were observed based on a reduction in food consumption and a decrease in body weight (change) of male and female F0 parental animals. The NOAEL for reproductive performance and fertility of the F0 parental animals was the highest tested dose of 75 mg/kg bw/d. The NOAEL for developmental toxicity in the F1 offspring was 25 mg/kg bw/d due to a delay in body weight development of F1 male and female pups at 75 mg/kg bw/d (BASF SE, 2018). In a 15 d range-finding study in rats (BASF SE, 2016), a NOAEL of 50 mg/kg bw/d was determined. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66f5080e-d2e4-4380-bd05-5c1bf14579d7/documents/4201e27b-12d8-4fea-82a9-4a6fd530cd28_5102867c-346f-4088-b97b-1103e7a59a20.html,,,,,, "[1S-(1α,2β,3α,5α)]-[2,6,6-trimethylbicyclo[3.1.1]hept-3-yl]methylamine",57357-85-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66f5080e-d2e4-4380-bd05-5c1bf14579d7/documents/4201e27b-12d8-4fea-82a9-4a6fd530cd28_5102867c-346f-4088-b97b-1103e7a59a20.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat "[1S-(1α,2β,3α,5α)]-[2,6,6-trimethylbicyclo[3.1.1]hept-3-yl]methylamine",57357-85-4," Oral: In an oral acute toxicity study in rats, an LD50 range of 200 - 2200 mg/kg bw was determined (BASF SE, 1994). Inhalation/Dermal: No study on acute inhalation and dermal toxicity was conducted due to the corrosive nature of the test substance. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66f5080e-d2e4-4380-bd05-5c1bf14579d7/documents/cce4ff22-1988-4a6a-84f1-b15265ef13fe_5102867c-346f-4088-b97b-1103e7a59a20.html,,,,,, "[1S-(1α,2β,3α,5α)]-[2,6,6-trimethylbicyclo[3.1.1]hept-3-yl]methylamine",57357-85-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66f5080e-d2e4-4380-bd05-5c1bf14579d7/documents/cce4ff22-1988-4a6a-84f1-b15265ef13fe_5102867c-346f-4088-b97b-1103e7a59a20.html,,oral,LD50,200 mg/kg bw,adverse effect observed, "[2-(29H,31H-phthalocyaninylmethyl)-1H-isoindole-1,3(2H)-dionato(2-)-N29,N30,N31,N32]copper",42739-64-0,"For the UVCB substance with a higher average substitution grade, a 14-day study in rats with 300 and 1000 mg/kg bw of the substance showed absence of toxicity. No indication of systemic uptake as determined via serum copper concentrations was observed. For support, data on the smaller copper phthalocyanine core (CAS 147-15-8) is used. It shows lack of effects in rats and mice upon subchronic feed exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/554d87ca-7b27-4614-bf06-6f472632ae33/documents/IUC5-09037e12-d28b-4c46-b453-581da178f6a8_aae7b52f-aa03-4037-a93a-238150f6352d.html,,,,,, "[2-(29H,31H-phthalocyaninylmethyl)-1H-isoindole-1,3(2H)-dionato(2-)-N29,N30,N31,N32]copper",42739-64-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/554d87ca-7b27-4614-bf06-6f472632ae33/documents/IUC5-09037e12-d28b-4c46-b453-581da178f6a8_aae7b52f-aa03-4037-a93a-238150f6352d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "[2-(29H,31H-phthalocyaninylmethyl)-1H-isoindole-1,3(2H)-dionato(2-)-N29,N30,N31,N32]copper",42739-64-0,The substance is judged to be practically non-toxic in rats after single ingestion and dermal application from experimental data of an analogue UVCB substance. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/554d87ca-7b27-4614-bf06-6f472632ae33/documents/IUC5-f2adb8ab-d652-484c-931d-97c95ab4d875_aae7b52f-aa03-4037-a93a-238150f6352d.html,,,,,, "[2-(29H,31H-phthalocyaninylmethyl)-1H-isoindole-1,3(2H)-dionato(2-)-N29,N30,N31,N32]copper",42739-64-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/554d87ca-7b27-4614-bf06-6f472632ae33/documents/IUC5-f2adb8ab-d652-484c-931d-97c95ab4d875_aae7b52f-aa03-4037-a93a-238150f6352d.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "[2-(29H,31H-phthalocyaninylmethyl)-1H-isoindole-1,3(2H)-dionato(2-)-N29,N30,N31,N32]copper",42739-64-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/554d87ca-7b27-4614-bf06-6f472632ae33/documents/IUC5-f2adb8ab-d652-484c-931d-97c95ab4d875_aae7b52f-aa03-4037-a93a-238150f6352d.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "[2-(29H,31H-phthalocyaninylmethyl)-1H-isoindole-1,3(2H)-dionato(2-)-N29,N30,N31,N32]copper",42739-64-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/554d87ca-7b27-4614-bf06-6f472632ae33/documents/IUC5-f2adb8ab-d652-484c-931d-97c95ab4d875_aae7b52f-aa03-4037-a93a-238150f6352d.html,,inhalation,discriminating conc.,5 mg/m3,no adverse effect observed, [2-(2-methoxyethoxy)ethoxy]acetic acid,16024-58-1, The oral LD50 value was found to be >2000 mg/kg bw in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/462df470-a0a2-4ab9-a851-d878ebc4c90c/documents/62bba7d2-57af-449f-8c46-5a66f5981165_8c65b19c-99ae-47c9-85f9-b110d718a9a7.html,,,,,, [2-(2-methoxyethoxy)ethoxy]acetic acid,16024-58-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/462df470-a0a2-4ab9-a851-d878ebc4c90c/documents/62bba7d2-57af-449f-8c46-5a66f5981165_8c65b19c-99ae-47c9-85f9-b110d718a9a7.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "[2,2'-[1,2-phenylenebis(nitrilomethylidyne)]-bis(phenolato)]-N,N',O,O'-nickel(II)",14406-71-4,"Repeated dermal toxicity:An OECD test guideline and GLP-compliant 28-day toxicity study was performed with test item (Pigment Orange 70) in Wistar rats.Groups of 10 male and 10 female rats received 0 and 1000 mg/kg/day by dermal occlusive application for 6 hours/ day (7 days/week). No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. viability, clinical appearance, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). The No-observed-adverse-effect level (NOAEL) of test item (Pigment Orange 70) was 1000 mg/kg bw/day in both sexes. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d9ee9e6-385b-413c-aa82-fbae0df72fc1/documents/dfe6addd-7202-4c1b-9525-9d9acff1334c_00e2ffcf-2760-4deb-8430-c89ac4b333f0.html,,,,,, "[2,2'-[1,2-phenylenebis(nitrilomethylidyne)]-bis(phenolato)]-N,N',O,O'-nickel(II)",14406-71-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d9ee9e6-385b-413c-aa82-fbae0df72fc1/documents/dfe6addd-7202-4c1b-9525-9d9acff1334c_00e2ffcf-2760-4deb-8430-c89ac4b333f0.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,">= 1,000 mg/kg bw/day",,rat "[2,2'-[1,2-phenylenebis(nitrilomethylidyne)]-bis(phenolato)]-N,N',O,O'-nickel(II)",14406-71-4,"Acute oral toxicity  Pigment Orange 70 did not cause any mortality or clinical signs or necropsy findings after single oral gavage administration to male and female rats at 10000 mg/kg bw in a OECD guideline compliant study. The LD50 (male/female rat) was greater than 10000 mg/kg body weight. Acute dermal toxicity  Pigment Orange 70 did not cause any mortality or clinical signs or necropsy findings after single dermal gavage administration to male and female rats at 2000 mg/kg bw in a OECD guideline compliant study. The LD50 (male/female rat) was greater than 2000 mg/kg body weight. Acute inhalation toxicityStudy was waived; substance is not classified for this endpoint. When aerosolized in respirable form, the substance is considered likely to behave like an inert dust. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d9ee9e6-385b-413c-aa82-fbae0df72fc1/documents/1a1679fa-1840-4f11-96b4-c0e1638c57da_00e2ffcf-2760-4deb-8430-c89ac4b333f0.html,,,,,, "[2,2'-[1,2-phenylenebis(nitrilomethylidyne)]-bis(phenolato)]-N,N',O,O'-nickel(II)",14406-71-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d9ee9e6-385b-413c-aa82-fbae0df72fc1/documents/1a1679fa-1840-4f11-96b4-c0e1638c57da_00e2ffcf-2760-4deb-8430-c89ac4b333f0.html,,oral,LD50,"> 10,000 mg/kg bw",no adverse effect observed, "[2,2'-[1,2-phenylenebis(nitrilomethylidyne)]-bis(phenolato)]-N,N',O,O'-nickel(II)",14406-71-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d9ee9e6-385b-413c-aa82-fbae0df72fc1/documents/1a1679fa-1840-4f11-96b4-c0e1638c57da_00e2ffcf-2760-4deb-8430-c89ac4b333f0.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "[2,3'-bis[[(2-hydroxyphenyl)methylene]amino]but-2-enedinitrilato(2-)-N2,N3,O2,O3]nickel",64696-98-6,No mortality was detected after a single dose of 5000 mg/kg bw in female rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b67a8a5-d80b-48fd-8074-c2e4b83d4cc0/documents/IUC5-65abe979-46a4-4406-bc96-6e119d843900_ec9f94dd-5b8e-40a0-a583-d4e382a02796.html,,,,,, "[2,3'-bis[[(2-hydroxyphenyl)methylene]amino]but-2-enedinitrilato(2-)-N2,N3,O2,O3]nickel",64696-98-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b67a8a5-d80b-48fd-8074-c2e4b83d4cc0/documents/IUC5-65abe979-46a4-4406-bc96-6e119d843900_ec9f94dd-5b8e-40a0-a583-d4e382a02796.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "[2,9,16,23-tetrachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper",16040-69-0,Repeated uptake of the phthalocyanine core and chlorinated derivatives did not cause treatment-related effects at the limit dose. ,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/96d32c7b-e8e5-46a7-9438-73114d3b6cf4/documents/IUC5-9a65ab07-4964-47d6-b2ac-de8e7b686778_869532a4-78b0-4245-b9dc-3111ff0421b3.html,,,,,, "[2,9,16,23-tetrachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper",16040-69-0,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/96d32c7b-e8e5-46a7-9438-73114d3b6cf4/documents/IUC5-9a65ab07-4964-47d6-b2ac-de8e7b686778_869532a4-78b0-4245-b9dc-3111ff0421b3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"4,500 mg/kg bw/day",,rat "[2,9,16,23-tetrachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper",16040-69-0,Copper phthalocyanine pigments are non-hazardous after single ingestion or short-term skin contact. They are considered to behave like inert dust in regard to dust inhalation. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96d32c7b-e8e5-46a7-9438-73114d3b6cf4/documents/IUC5-71e223b1-85c2-43b9-bb7e-98d2564153a0_869532a4-78b0-4245-b9dc-3111ff0421b3.html,,,,,, "[2,9,16,23-tetrachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper",16040-69-0,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96d32c7b-e8e5-46a7-9438-73114d3b6cf4/documents/IUC5-71e223b1-85c2-43b9-bb7e-98d2564153a0_869532a4-78b0-4245-b9dc-3111ff0421b3.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "[2,9,16,23-tetrachloro-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]copper",16040-69-0,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96d32c7b-e8e5-46a7-9438-73114d3b6cf4/documents/IUC5-71e223b1-85c2-43b9-bb7e-98d2564153a0_869532a4-78b0-4245-b9dc-3111ff0421b3.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, [2-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxoallyl]oxy]ethyl][3-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxoallyl]oxy]propyl]dimethylammonium chloride,78181-99-4,"In a reliable combined repeated dose and reproductive/developmental toxicity screening test (OECD TG 422) with the registered dye by oral gavage in rats systemic toxicity occurred at a dose level of 1000 mg/kg bw/day. The NOAEL was determined to be 300 mg/kg bw/day. As specific target organs the kidney and the liver were affected at the highest dose tested (1000 mg/kg bw/day), however, without influence on classification and labelling. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/face0f39-b310-42d4-b45c-3d4c85ff5ac3/documents/IUC5-3d751ba7-5f29-4f60-adf3-21452dc14627_e8110253-20bb-4f15-b00e-d4b019ae91d0.html,,,,,, [2-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxoallyl]oxy]ethyl][3-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxoallyl]oxy]propyl]dimethylammonium chloride,78181-99-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/face0f39-b310-42d4-b45c-3d4c85ff5ac3/documents/IUC5-3d751ba7-5f29-4f60-adf3-21452dc14627_e8110253-20bb-4f15-b00e-d4b019ae91d0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat [2-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxoallyl]oxy]ethyl][3-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxoallyl]oxy]propyl]dimethylammonium chloride,78181-99-4,In an acute oral toxicity study with a dye preparation containing 50% dye the LD50 value was determined to be 2700 mg/kg bw. In an acute dermal toxicity study the LD50 value of the dye was > 2000 mg/kg bw. The intraperitoneal injection with a dye preparation containing 50% dye indicated a LD50 value between 50 and 200 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/face0f39-b310-42d4-b45c-3d4c85ff5ac3/documents/IUC5-241a78b1-db85-4d43-abfc-137eb9a1f31b_e8110253-20bb-4f15-b00e-d4b019ae91d0.html,,,,,, [2-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxoallyl]oxy]ethyl][3-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxoallyl]oxy]propyl]dimethylammonium chloride,78181-99-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/face0f39-b310-42d4-b45c-3d4c85ff5ac3/documents/IUC5-241a78b1-db85-4d43-abfc-137eb9a1f31b_e8110253-20bb-4f15-b00e-d4b019ae91d0.html,,oral,LD50,"2,700 mg/kg bw",adverse effect observed, [2-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxoallyl]oxy]ethyl][3-[[2-cyano-3-[4-(diethylamino)phenyl]-1-oxoallyl]oxy]propyl]dimethylammonium chloride,78181-99-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/face0f39-b310-42d4-b45c-3d4c85ff5ac3/documents/IUC5-241a78b1-db85-4d43-abfc-137eb9a1f31b_e8110253-20bb-4f15-b00e-d4b019ae91d0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, [2-[[2-cyano-3-[4-[ethylbenzylamino]phenyl]-1-oxoallyl]oxy]ethyl]trimethylammonium chloride,71550-24-8," In a test according to OECD 422 the substance was administered daily at 0, 100, 300 and 600 mg/kg bw (in PEG400) during 14 days of pre-mating and maximum 14 days of mating in both males and females, during the gestation period and up to post-natal day 12 in females. Males were dosed after the mating period until the minimum total dosing period of 28 days were completed. During the period of administration, the animals were observed each day for signs of toxicity, body weight and food consumption were measured. Functional observations were performed for all animals before treatment and in five males and females in the last week of treatment Haematological, clinical biochemistry and urine investigation were performed on selected males and females from each group. Blood samples from the adult males were assessed for serum levels for thyroid hormones (T4). After 14 days of treatment to both male and female, animals were mated (1:1) for a maximum of 14 days. The males were sacrificed after completion of the mating period on treatment day 29 and the females were sacrificed on post natal day 13. A full histopathological evaluation of the preserved tissues was performed on high dose and control animals For the testes, a detailed qualitative examination was made; taking into account the tubular stages of the spermatogenic cycle at evaluation of additional hematoxylin-PAS (Periodic Acid Schiff) stained slides. All gross lesions macroscopically identified were examined microscopically in all animals. During the treatment period of this study, one mortality was observed in high dose females, that could be attributed to a dosing error. No treatment related adverse effects were noted on clinical signs, body weight (gain), food consumption, behavioral parameters, haematology, clinical biochemistry, urinalyses, macroscopy, and histopathology. In addition no effects were seen on estrous cycle, male sperm and thyroxine levels (in male adults). In conclusion in absence of treatment related adverse effects the NOAEL is set at 600 mg/kg bw. In a 90-day study rats (20/sex/treatment) were exposed to the test substance at 0.03, 0.1 and 0.3% in drinking water. Control groups received untreated drinking water or drinking water spiked with 0.09% acetic acid. 7 males died at 0.3%. These animals showed signs of irritation of the GI tract. Other effects at this dose level in males included reduced food and water intake, decreased white and red blood cell numbers, decreased platelets, decreased creatinine, glucose and cholesterol levels and increased thyroid, kidney and liver weight. In females at 0.3% similar effects on blood parameters were found, as well as an increased kidney and decreased lung weights. None of the effects were related to histopathological findings. In the other dose groups similar findings were reported, but these were either incidental or reported in one sex only and again had no relationship with histopathology. Therefore it is concluded that the NOAEL from this study is 0.1% in drinking water (equivalent to 84 mg/kg bw in females and 96 mg/kg bw in males). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20245c6d-81bf-4b97-a061-5819939332b4/documents/9be03c19-aea1-4cb4-b4f7-af7c08f0ff0a_fced9156-962b-4563-8a42-6d666345b8cc.html,,,,,, [2-[[2-cyano-3-[4-[ethylbenzylamino]phenyl]-1-oxoallyl]oxy]ethyl]trimethylammonium chloride,71550-24-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20245c6d-81bf-4b97-a061-5819939332b4/documents/9be03c19-aea1-4cb4-b4f7-af7c08f0ff0a_fced9156-962b-4563-8a42-6d666345b8cc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat [2-[[2-cyano-3-[4-[ethylbenzylamino]phenyl]-1-oxoallyl]oxy]ethyl]trimethylammonium chloride,71550-24-8," Five rats/sex received 2.0, 3.1 and 5.0 mL/kg of the substance by oral gavage. Mortality was observed at 3.1 mL/kg (1 female) and at 5 mL/kg (1 male and 3 females). Bodyweight gain was decreased in males dosed at 5.0 mL/kg. Clinical signs included poor condition, piloerection and sedation in animals at 3.1 mL/kg and above. At necropsy erosion of the stomach mucosa and hardening of the fundus area was seen in decedents (Bayer 1985). The LD50 of the substance tested is > 5.0 mL/kg bw (corrected for purity > 3.5 mL/kg). This result is confirmed by another test where the LD50 was assessed to be 3800 mg/kg bw (Bayer 1983). In view of these results that are indicative for low toxicity and the fact that the substance is corrosive the acute dermal study has been waived. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20245c6d-81bf-4b97-a061-5819939332b4/documents/1e97c51b-5af2-4d22-99d8-37952152e0ef_fced9156-962b-4563-8a42-6d666345b8cc.html,,,,,, [2-[[2-cyano-3-[4-[ethylbenzylamino]phenyl]-1-oxoallyl]oxy]ethyl]trimethylammonium chloride,71550-24-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20245c6d-81bf-4b97-a061-5819939332b4/documents/1e97c51b-5af2-4d22-99d8-37952152e0ef_fced9156-962b-4563-8a42-6d666345b8cc.html,,oral,LD50,"3,500 mg/kg bw",adverse effect observed, [2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium acetate,82205-20-7," No data is available for the target substance. Thus, available data from the structural analogue (chloride salt) of the target substance was used in a read-across approach. Details on the read-across rational are provided in section 13. The source substance was tested in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422). No adverse effects were found after oral administration of the test item in male and female rats. Based on the results, the NOAEL is considered to be 250 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/268064cd-245f-490e-a165-1a85ed85662e/documents/8d0e4037-3c01-4c5e-8066-ac768a656bf6_502f94e0-6e14-4123-8f9c-b899eb2e617b.html,,,,,, [2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium acetate,82205-20-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/268064cd-245f-490e-a165-1a85ed85662e/documents/8d0e4037-3c01-4c5e-8066-ac768a656bf6_502f94e0-6e14-4123-8f9c-b899eb2e617b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat [2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium acetate,82205-20-7," In an acute oral toxicity study (equivalent to OECD 401), groups of young Wistar rats (5/sex/dose) were given a single oral dose of a liquid mixture containing the target substance (57.2 %) at doses of 2.0, 3.1, 3.5, 4.0, 5.0 and 6.3 mL/kg bw and were observed for 14 days. Mortality occurred during the first 3 days after application. Clinical signs of toxicity were observed for the dose groups 3.1 to 6.3 mL/kg bw. The clinical signs included reduction of spontaneous activity, piloerection, and apathy. Gross pathology evaluation on dead animals of the 3.1 mL to 6.3 mL/kg bw dose groups revealed a reddish colouration of the stomach lining by the test substance. The sacrificed animals at the end of the observation period of the dose groups 2.0 to 5.0 mL/kg bw showed no adverse effects. Based on the results, the combined oral LD50 was determined to be 3.8 mL/kg bw (equals 4370 mg/kg bw based on the density of 1.15 g/mL). The acute toxicity of Basic Red 18:1 Chloride was investigated following dermal administration of a single dose to the rat. A single dose of 2000 mg/kg body weight was administered to a group of 5 male and 5 female animals for 24 hours. After 14 days, all animals were killed and subjected to necropsy examination. No mortality occurred and only red staining at the treated site, due to the colour of the test substance, was observed in all male and female animals from Day 2 up to the end of the observation period. The body weight changes observed during the study were within the expected range for this species and age of animals. Only red staining at the treatment site, due to the colour of the test substance, was found at necropsy in all animals at termination of the study. These results indicate that the test item, Basic Red 18:1 Chloride, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg body weight. The lack of mortality demonstrates the LD50to be greater than 2000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/268064cd-245f-490e-a165-1a85ed85662e/documents/2d02ba57-649b-4490-9bda-73cb64c52057_502f94e0-6e14-4123-8f9c-b899eb2e617b.html,,,,,, [2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium acetate,82205-20-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/268064cd-245f-490e-a165-1a85ed85662e/documents/2d02ba57-649b-4490-9bda-73cb64c52057_502f94e0-6e14-4123-8f9c-b899eb2e617b.html,,oral,LD50,"4,370 mg/kg bw",no adverse effect observed, [2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium acetate,82205-20-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/268064cd-245f-490e-a165-1a85ed85662e/documents/2d02ba57-649b-4490-9bda-73cb64c52057_502f94e0-6e14-4123-8f9c-b899eb2e617b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, [2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium chloride,54229-13-9," The target substance was tested in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422). No adverse effects were found after oral administration of the test item in male and female rats. Based on the results, the NOAEL is considered to be 250 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e842f72-d7cb-45e9-a442-95aabb15c295/documents/e7017492-ca22-4317-bc3e-422f6cc3928f_406842a2-f0ca-465c-a130-e8edaf918fa8.html,,,,,, [2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium chloride,54229-13-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e842f72-d7cb-45e9-a442-95aabb15c295/documents/e7017492-ca22-4317-bc3e-422f6cc3928f_406842a2-f0ca-465c-a130-e8edaf918fa8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat [2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium chloride,54229-13-9," Oral: the lowest LD50 for the substance with the highest purity was determined at 1770 mg/kg bw (OECD 401). Dermal: no mortality occured up to 2000 mg/kg bw, no LD50 was determined (OECD 402). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e842f72-d7cb-45e9-a442-95aabb15c295/documents/55c182cf-bc89-439d-a89b-b1f050f12438_406842a2-f0ca-465c-a130-e8edaf918fa8.html,,,,,, [2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl](2-hydroxypropyl)dimethylammonium chloride,54229-13-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e842f72-d7cb-45e9-a442-95aabb15c295/documents/55c182cf-bc89-439d-a89b-b1f050f12438_406842a2-f0ca-465c-a130-e8edaf918fa8.html,,oral,LD50,"1,770 mg/kg bw",adverse effect observed, [2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl]trimethylammonium acetate,85187-95-7,LD50(male/female) = 2122 mg/kg bw     ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3143c09e-c4c4-4b67-ab16-3cf4fb2b8912/documents/6bd56c21-a303-4678-836e-0dfc15a6df4c_aa44e784-9cb1-4094-bc02-796a944f7092.html,,,,,, [2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl]trimethylammonium acetate,85187-95-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3143c09e-c4c4-4b67-ab16-3cf4fb2b8912/documents/6bd56c21-a303-4678-836e-0dfc15a6df4c_aa44e784-9cb1-4094-bc02-796a944f7092.html,,oral,LD50,"2,122 mg/kg bw",no adverse effect observed, [2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl]trimethylammonium chloride,25198-22-5,LD50(male/female) = 2122 mg/kg bw     ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b031c896-c635-4ae5-8a36-96556ea60455/documents/IUC5-a7c7b591-505f-4f8e-b1d4-c601f4c3cd5f_0ffa7376-c225-47d4-83f0-f38156c6889f.html,,,,,, [2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl]trimethylammonium chloride,25198-22-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b031c896-c635-4ae5-8a36-96556ea60455/documents/IUC5-a7c7b591-505f-4f8e-b1d4-c601f4c3cd5f_0ffa7376-c225-47d4-83f0-f38156c6889f.html,,oral,LD50,"2,122 mg/kg bw",no adverse effect observed, "[2-[4-(dihexylamino)-2-methylbenzylidene]benzo[b]thien-3(2H)-ylidene]malononitrile S,S-dioxide",74239-96-6, Oral LD50 (female) > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79cecf04-6262-4e53-9a2b-f84efb6e03d5/documents/c958b0bb-8d19-4b2b-9c02-6038594f8e85_1822cae9-188b-44a0-b009-0ae12b90bb31.html,,,,,, "[2-[4-(dihexylamino)-2-methylbenzylidene]benzo[b]thien-3(2H)-ylidene]malononitrile S,S-dioxide",74239-96-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79cecf04-6262-4e53-9a2b-f84efb6e03d5/documents/c958b0bb-8d19-4b2b-9c02-6038594f8e85_1822cae9-188b-44a0-b009-0ae12b90bb31.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]iron",132-16-1," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9df62acc-d7a5-4323-870c-a7ab68169639/documents/390095e5-f370-4748-a2a9-df8d34f53b40_09a7f4cc-e094-4324-92e9-0fd0a7424c05.html,,,,,, "[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]iron",132-16-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9df62acc-d7a5-4323-870c-a7ab68169639/documents/390095e5-f370-4748-a2a9-df8d34f53b40_09a7f4cc-e094-4324-92e9-0fd0a7424c05.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "[29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]zinc",14320-04-8,"It is not expected that Zn-phtholocyanine is absorbed after ingestion. Therefore, no hazard is expected for oral exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b91e5fdd-c05e-468c-acb5-83c8160566ee/documents/IUC5-1977d66d-1d71-4f44-8479-44255c5df3c1_0205014d-1442-4e7f-af1c-55bc2967a556.html,,,,,, "[2R-[2α(E),3β]]-2-[2-(3,4-dihydro-6-methoxy-1(2H)-naphthylidene)ethyl]-2-ethyl-3-hydroxycyclopentan-1-one",51773-49-0,"LD50 oral (rat): > 2000 mg/kg bw [Draft report, Kurth and Vorrath 1998]LD50 dermal (rat): > 2000 mg/kg bw [Draft report, Kurth 1998] ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a1191e7-c522-4e48-96cb-ff6d90ead675/documents/IUC5-7c80f488-3aad-4d75-b289-423d08dae839_7d437686-527b-4fd3-80c4-2041b905dbf1.html,,,,,, "[2R-[2α(E),3β]]-2-[2-(3,4-dihydro-6-methoxy-1(2H)-naphthylidene)ethyl]-2-ethyl-3-hydroxycyclopentan-1-one",51773-49-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a1191e7-c522-4e48-96cb-ff6d90ead675/documents/IUC5-7c80f488-3aad-4d75-b289-423d08dae839_7d437686-527b-4fd3-80c4-2041b905dbf1.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "[2R-[2α(E),3β]]-2-[2-(3,4-dihydro-6-methoxy-1(2H)-naphthylidene)ethyl]-2-ethyl-3-hydroxycyclopentan-1-one",51773-49-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a1191e7-c522-4e48-96cb-ff6d90ead675/documents/IUC5-7c80f488-3aad-4d75-b289-423d08dae839_7d437686-527b-4fd3-80c4-2041b905dbf1.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "[2S-[2α,5α,6β(S*)]]-6-[[[[(4-ethyl-2,3-dioxopiperazin-1-yl)carbonyl]amino]phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid",61477-96-1," Data waiving (study scientifically not necessary / other information available): a short-term toxicity study by the oral route does not need to be conducted because appropriate intravenous studies are available and intravenous is the most appropriate route, given that the substance is not absorbed by the oral route (absorption of 0.5% in rats). Key study. Based on a study on the sodium salt of piperacillin (analogue substance), the NOAEL of the substance is considered to be 959 mg/kg bw/d in rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a87a904d-8f4e-46bd-a085-afc6b7c4d7db/documents/ea57cca9-6a0c-4fd8-bffe-c13748e064b6_1ef91a8c-0b1c-46f8-b2a8-b42f4dfb7071.html,,,,,, "[2S-[2α,5α,6β(S*)]]-6-[[[[(4-ethyl-2,3-dioxopiperazin-1-yl)carbonyl]amino]phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid",61477-96-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a87a904d-8f4e-46bd-a085-afc6b7c4d7db/documents/ea57cca9-6a0c-4fd8-bffe-c13748e064b6_1ef91a8c-0b1c-46f8-b2a8-b42f4dfb7071.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,959 mg/kg bw/day,,rabbit "[2S-[2α,5α,6β(S*)]]-6-[[[[(4-ethyl-2,3-dioxopiperazin-1-yl)carbonyl]amino]phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid",61477-96-1," Acute Oral Toxicity: Weight of evidence. Based on the available information for the read-across approach, the target substance has an oral LD50 > 10000 mg/kg bw. Acute Inhalation Toxicity: Data waiving (study scientifically not necessary / other information available): According to column 2 of REACH Annex VIII, the study does not need to be conducted, as data for both oral and dermal routes is available. Acute Dermal Toxicity: Data waiving (study scientifically not necessary / other information available): According to column 2 of REACH Annex VII, the study does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route, and no systemic effects have been observed / are predicted for studies with dermal exposure. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a87a904d-8f4e-46bd-a085-afc6b7c4d7db/documents/66e51c62-fb31-4302-a7e3-384aff2b9b9e_1ef91a8c-0b1c-46f8-b2a8-b42f4dfb7071.html,,,,,, "[2S-[2α,5α,6β(S*)]]-6-[[[[(4-ethyl-2,3-dioxopiperazin-1-yl)carbonyl]amino]phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid",61477-96-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a87a904d-8f4e-46bd-a085-afc6b7c4d7db/documents/66e51c62-fb31-4302-a7e3-384aff2b9b9e_1ef91a8c-0b1c-46f8-b2a8-b42f4dfb7071.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "[3-(2,3-epoxypropoxy)propyl]diethoxymethylsilane",2897-60-1," In the key study for repeated dose toxicity via oral gavage, administration of the test material to rat for 28 days resulted in no adverse effects, and a NOAEL of >1000 mg/kg bw/day was identified (Safepharm, 2004b). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b69f17c2-2128-4df6-9a5b-c41291b05c77/documents/0ab059dc-da67-4255-af7e-8a4770cd4aa1_61177aea-aabe-4be3-93b2-08f6b341daaf.html,,,,,, "[3-(2,3-epoxypropoxy)propyl]diethoxymethylsilane",2897-60-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b69f17c2-2128-4df6-9a5b-c41291b05c77/documents/0ab059dc-da67-4255-af7e-8a4770cd4aa1_61177aea-aabe-4be3-93b2-08f6b341daaf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "[3-(2,3-epoxypropoxy)propyl]diethoxymethylsilane",2897-60-1," The key studies for acute oral and dermal toxicity were conducted according to appropriate OECD guidelines and in compliance with GLP. The acute oral and dermal LD50 values are concluded to be >2000 mg/kg (Dow Corning Corporation, 2008, WIL, 1999). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b69f17c2-2128-4df6-9a5b-c41291b05c77/documents/7de2b793-4c85-4b18-825c-5d85cb642bdc_61177aea-aabe-4be3-93b2-08f6b341daaf.html,,,,,, "[3-(2,3-epoxypropoxy)propyl]diethoxymethylsilane",2897-60-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b69f17c2-2128-4df6-9a5b-c41291b05c77/documents/7de2b793-4c85-4b18-825c-5d85cb642bdc_61177aea-aabe-4be3-93b2-08f6b341daaf.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "[3-(2,3-epoxypropoxy)propyl]diethoxymethylsilane",2897-60-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b69f17c2-2128-4df6-9a5b-c41291b05c77/documents/7de2b793-4c85-4b18-825c-5d85cb642bdc_61177aea-aabe-4be3-93b2-08f6b341daaf.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "[3-(2,3-epoxypropoxy)propyl]dimethoxymethylsilane",65799-47-5," There are no acute oral toxicity studies available for [3-(2,3-epoxypropoxy)propyl]dimethoxy(methyl)silane (CAS 65799-47-5). Reliable data have therefore been read across from structural analogues. An acute oral toxicity study conducted according to a protocol similar to OECD 401, but not in compliance with GLP, reported an LD50 of 8025 mg/kg bw for [3-(2,3-epoxypropoxy)propyl]trimethoxysilane (Dow Corning corporation, 1976).   An acute oral toxicity study for [3-(2,3-epoxypropoxy)propyl]diethoxy(methyl)silane was conducted according to appropriate OECD guidelines and in compliance with GLP. The acute oral LD50 value was concluded to be >2000 mg/kg (Dow Corning Corporation, 2008). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/029fefc4-fdb7-4cb5-a2f2-92dd2de21518/documents/1c62f983-9d95-4f85-ab8f-9e213ac27195_43a47f6a-62fb-494d-a68c-574c94c95245.html,,,,,, "[3-(2,3-epoxypropoxy)propyl]triethoxysilane",2602-34-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): A supporting inhalation study is available for the hydrolysate of the surrogate substance [3-(2,3-epoxypropoxy)propyl]trimethoxysilane. However, this is not considered to be a key study for the registration substance. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): A supporting inhalation study is available for the hydrolysate of the surrogate substance [3-(2,3-epoxypropoxy)propyl]trimethoxysilane. However, this is not considered to be a key study for the registration substance. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/346d73dd-768b-4b4a-b46f-023676aa93c2/documents/862c9a82-1ab1-4452-aba1-f36280a44b18_efb26f07-3440-4f0e-8717-0a451f4e2b33.html,,,,,, "[3-(2,3-epoxypropoxy)propyl]triethoxysilane",2602-34-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/346d73dd-768b-4b4a-b46f-023676aa93c2/documents/862c9a82-1ab1-4452-aba1-f36280a44b18_efb26f07-3440-4f0e-8717-0a451f4e2b33.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "[3-(2,3-epoxypropoxy)propyl]triethoxysilane",2602-34-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/346d73dd-768b-4b4a-b46f-023676aa93c2/documents/918fb061-1571-42d9-b670-a4deaa3560da_efb26f07-3440-4f0e-8717-0a451f4e2b33.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "[3-(2,3-epoxypropoxy)propyl]triethoxysilane",2602-34-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/346d73dd-768b-4b4a-b46f-023676aa93c2/documents/918fb061-1571-42d9-b670-a4deaa3560da_efb26f07-3440-4f0e-8717-0a451f4e2b33.html,,inhalation,LC50,"> 5,300 mg/m3",adverse effect observed, [3-(triethoxysilyl)propyl]urea,23779-32-0,Oral (OECD TG 407): NOAEL = 1228 mg/kg bw (highest dose tested)Dermal: no data availableInhalation: no data available ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c1d37b4-4f05-41f3-a631-13d2214e9949/documents/IUC5-339cada9-87e1-4eb4-871e-ee4eb516d532_e0a03dd6-f60f-488d-af9e-1d229489a426.html,,,,,, [3-(triethoxysilyl)propyl]urea,23779-32-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c1d37b4-4f05-41f3-a631-13d2214e9949/documents/IUC5-339cada9-87e1-4eb4-871e-ee4eb516d532_e0a03dd6-f60f-488d-af9e-1d229489a426.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,228 mg/kg bw/day",,rat [3-(triethoxysilyl)propyl]urea,23779-32-0,"Oral (OECD 401, rat): LD50 > 5000 mg/kg bwInhalation: No data available (data waiving according to Column 2 of REACH Annex VIII, Section 8.5.2)Dermal (OECD 402, rat): LD50 > 2457 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c1d37b4-4f05-41f3-a631-13d2214e9949/documents/IUC5-de1c50d2-7c26-49dc-b234-db6dcac63561_e0a03dd6-f60f-488d-af9e-1d229489a426.html,,,,,, [3-(triethoxysilyl)propyl]urea,23779-32-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c1d37b4-4f05-41f3-a631-13d2214e9949/documents/IUC5-de1c50d2-7c26-49dc-b234-db6dcac63561_e0a03dd6-f60f-488d-af9e-1d229489a426.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, [3-(triethoxysilyl)propyl]urea,23779-32-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c1d37b4-4f05-41f3-a631-13d2214e9949/documents/IUC5-de1c50d2-7c26-49dc-b234-db6dcac63561_e0a03dd6-f60f-488d-af9e-1d229489a426.html,,dermal,discriminating dose,"2,457 mg/kg bw",no adverse effect observed, [3-(trimethoxysilyl)propyl]urea,23843-64-3,"RDT oral (OECD 407), rat: NOAEL = 1228 mg/kg bw/day (RA from CAS 116912-64-2)RDT inhalation: no data availableRDT dermal: no data available ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b61b3d3e-be16-43b1-a26c-f6316a528899/documents/da614932-ab9a-4496-8636-b214bf3b7e51_06e8cbac-77ea-4347-96d0-1b6d796d67f9.html,,,,,, [3-(trimethoxysilyl)propyl]urea,23843-64-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b61b3d3e-be16-43b1-a26c-f6316a528899/documents/da614932-ab9a-4496-8636-b214bf3b7e51_06e8cbac-77ea-4347-96d0-1b6d796d67f9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,228 mg/kg bw/day",,rat [3-(trimethoxysilyl)propyl]urea,23843-64-3,"Oral (OECD 401), rat: LD50 >5000 mg/kg bwInhalation: no data available Dermal (OECD 402), rat: LD50 >2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b61b3d3e-be16-43b1-a26c-f6316a528899/documents/3c3ae0f4-edd6-4810-b0aa-ba7089652ece_06e8cbac-77ea-4347-96d0-1b6d796d67f9.html,,,,,, [3-(trimethoxysilyl)propyl]urea,23843-64-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b61b3d3e-be16-43b1-a26c-f6316a528899/documents/3c3ae0f4-edd6-4810-b0aa-ba7089652ece_06e8cbac-77ea-4347-96d0-1b6d796d67f9.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, [3-(trimethoxysilyl)propyl]urea,23843-64-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b61b3d3e-be16-43b1-a26c-f6316a528899/documents/3c3ae0f4-edd6-4810-b0aa-ba7089652ece_06e8cbac-77ea-4347-96d0-1b6d796d67f9.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "[3-methyl-5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4-pentadienyl]triphenylphosphonium sulphate",751-83-7,No data are available. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/679e879e-1326-4766-8adf-8068b66c16d5/documents/IUC5-7ad79d0c-31d5-49e1-a4c4-2fa3202ffeeb_ca0e5016-9dd3-441b-9fcc-8a3cb4ea9772.html,,,,,, "[3-methyl-5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4-pentadienyl]triphenylphosphonium sulphate",751-83-7,"ORAL LD50, rat, combined = 1735 mg/kg bw (95% C.I. 1248 - 2412) DERMAL No data are available. INHALATION No mortality was observed when 12 rats were exposed by inhalation to an atmosphere that had been saturated at 20°C with the volatile parts of C15-Salz (purity not given) for up to 8 hours. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/679e879e-1326-4766-8adf-8068b66c16d5/documents/IUC5-af781b91-443d-45ac-8a51-a69c40e80c63_ca0e5016-9dd3-441b-9fcc-8a3cb4ea9772.html,,,,,, "[3-methyl-5-(2,6,6-trimethyl-1-cyclohexen-1-yl)-2,4-pentadienyl]triphenylphosphonium sulphate",751-83-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/679e879e-1326-4766-8adf-8068b66c16d5/documents/IUC5-af781b91-443d-45ac-8a51-a69c40e80c63_ca0e5016-9dd3-441b-9fcc-8a3cb4ea9772.html,,oral,LD50,"1,735 mg/kg bw",, "[4-[[4-(diethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]diethylammonium acetate",76994-37-1,The oral LD50 was 206 mg/kg bw in rats after an observation period of 14 days. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eaabb0a2-bb31-4098-b87b-f2d619b3c9c9/documents/IUC5-b3e1badb-e739-4eb7-b682-ac4544fc1ca6_f641e33b-be92-4f61-abc8-188869f1b061.html,,,,,, "[4-[[4-(diethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]diethylammonium acetate",76994-37-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eaabb0a2-bb31-4098-b87b-f2d619b3c9c9/documents/IUC5-b3e1badb-e739-4eb7-b682-ac4544fc1ca6_f641e33b-be92-4f61-abc8-188869f1b061.html,,oral,LD50,206 mg/kg bw,adverse effect observed, "[4-[[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate",84434-47-9," Prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound N-(4-{[4-(dimethylamino)phenyl][4-(methylamino) phenyl ] methylene}cyclohexa -2,5-dien-1-ylidene)-N-meth..(84434-47-9). The study assumed the use of male and female Wistar rats in subchronic study of 7 days on daily basis . No significant alterations were noted at the dose level of 452.0mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for N-(4-{[4-(dimethylamino)phenyl][4-(methylamino) phenyl ] methylene}cyclohexa -2,5-dien-1-ylidene)-N-meth.is considered to be 452.0mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb6ef608-cc0b-4d5b-a66b-e004ef5a9d6e/documents/7b6d1364-997f-4cbd-b759-5de13a902f7d_a7149de8-f041-49bd-bcfb-c3aeefeaa72f.html,,,,,, "[4-[[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate",84434-47-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb6ef608-cc0b-4d5b-a66b-e004ef5a9d6e/documents/7b6d1364-997f-4cbd-b759-5de13a902f7d_a7149de8-f041-49bd-bcfb-c3aeefeaa72f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,452 mg/kg bw/day,,rat "[4-[[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate",84434-47-9," Acute oral toxicity:  Acute oral toxicity dose (LD50) was determined by Sustainability Support Services (Europe) AB and the acute oral LD50 (Cut-off value) was 500 mg/kg bw. It was concluded that LD50 value is between 300 - 2000 mg/kg bw. Thus, acute toxicity study of [4-[[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate (CAS No. 84434-47-9), when administered via oral route in Sprague Dawley rats falls into the “Category 4 (300 – ≤ 2000)” criteria of CLP. Acute Inhalation Toxicity: [4-[[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylene] cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate (84434-47-9) has very low vapour pressure (2.41E-013Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal toxicity:  Acute dermal median lethal dose (LD50) of [4-[[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylene] cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate (CAS No. 84434-47-9), when administered to male and female Sprague Dawley rats was found to be greater than 2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that [4-[[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylene] cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate (CAS No. 83803-79-6) falls into the “Category 5 (>2000)” criteria of CLP. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb6ef608-cc0b-4d5b-a66b-e004ef5a9d6e/documents/dc97db6d-53bc-4039-ad28-c01a15f65778_a7149de8-f041-49bd-bcfb-c3aeefeaa72f.html,,,,,, "[4-[[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate",84434-47-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb6ef608-cc0b-4d5b-a66b-e004ef5a9d6e/documents/dc97db6d-53bc-4039-ad28-c01a15f65778_a7149de8-f041-49bd-bcfb-c3aeefeaa72f.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "[4-[[4-(dimethylamino)phenyl][4-(methylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate",84434-47-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb6ef608-cc0b-4d5b-a66b-e004ef5a9d6e/documents/dc97db6d-53bc-4039-ad28-c01a15f65778_a7149de8-f041-49bd-bcfb-c3aeefeaa72f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate",83803-79-6," Prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)naphthalen-1-yl)methylene)cyclohexa-2,5-dienylidene)-..(83803-79-6).The study assumed the use of male and female Wistar rats in subacute study of 28 days. No significant alterations were noted at the dose level of 589.33 mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for N-(4-((4-(dimethylamino)phenyl)(4-(phenylamino)naphthalen-1-yl)methylene)cyclohexa-2,5-dienylidene)-..(83803-79-6) is considered to be 462.0mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8da22ae-5527-4246-9a22-c8b20d9fb929/documents/6aa79107-f551-4fd2-a00c-e57c55356d3f_0a74a2fb-0820-4f82-bfb5-d8c37703bf82.html,,,,,, "[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate",83803-79-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8da22ae-5527-4246-9a22-c8b20d9fb929/documents/6aa79107-f551-4fd2-a00c-e57c55356d3f_0a74a2fb-0820-4f82-bfb5-d8c37703bf82.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,589.33 mg/kg bw/day,,rat "[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate",83803-79-6," Acute oral toxicity:  Acute oral toxicity dose (LD50) was determined by Sustainability Support Services (Europe) AB and the acute oral LD50 (Cut-off value) was 500 mg/kg bw.It was concluded that LD50 value is between 300 - 2000 mg/kg bw.Thus, acute toxicity study of [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene] cyclohexa-2,5-dien-1-ylidene] dimethylammonium acetate (CAS No. 83803-79-6), when administered via oral route in Sprague Dawley rats falls into the “Category 4 (300 – ≤ 2000)” criteria of CLP. Acute inhalation toxicity: [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene] cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate has very low vapor pressure 5.76E-018Pa, so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute dermal toxicity: Acute dermal median lethal dose (LD50) of [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium acetate (CAS No. 83803-79-6), when administered to male and female Sprague Dawley rats was found to be greater than 2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that [4-[[4-anilino- 1-naphthyl][4-(dimethylamino)phenyl] methylene]cyclohexa-2,5-dien-1-ylidene] dimethylammonium acetate (CAS No. 83803-79-6) falls into the “Category 5 (>2000)” criteria of CLP. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8da22ae-5527-4246-9a22-c8b20d9fb929/documents/80244ad9-7b92-4cde-89c4-a56bb58960a4_0a74a2fb-0820-4f82-bfb5-d8c37703bf82.html,,,,,, "[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate",83803-79-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8da22ae-5527-4246-9a22-c8b20d9fb929/documents/80244ad9-7b92-4cde-89c4-a56bb58960a4_0a74a2fb-0820-4f82-bfb5-d8c37703bf82.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "[4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate",83803-79-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8da22ae-5527-4246-9a22-c8b20d9fb929/documents/80244ad9-7b92-4cde-89c4-a56bb58960a4_0a74a2fb-0820-4f82-bfb5-d8c37703bf82.html,,dermal,LD50,"2,000 mg/kg bw",, "[4-[bis[4-(dimethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene]dimethylammonium acetate",67939-65-5," Repeated dose toxicity: Oral Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for N-(4-{bis[4-(dimethylamino)phenyl]methylene} cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium acetate. The study assumed the use of male and female F344 rats in a 103 weeks toxicity study. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Level (NOAEL) for N-(4-{bis[4-(dimethylamino)phenyl]methylene} cyclohexa-2,5-dien-1-ylidene) -N-methylmethanaminium acetate is predicted to be 321.200012207 mg/Kg bw/day.   Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. Repeated dose toxicity: Inhalation N-(4-{bis[4-(dimethylamino)phenyl]methylene} cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium acetate has very low vapor pressure of 2.04E-010 Pa, so the potential for the generation of inhalable vapurs is very low, also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore is end point was considered for waiver Repeated dose toxicity: Dermal The acute dermal toxicity value for N-(4-{bis[4-(dimethylamino)phenyl]methylene} cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium acetate (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not irritating and not sensitizing to the skin. Based on these considerations, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3959a61c-e968-4510-a934-81f5e8618ab0/documents/c8bf762f-244d-4472-82c3-eec354ada7af_1f2718c4-cf6c-40c9-a8e7-c3cd5eda4af8.html,,,,,, "[4-[bis[4-(dimethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene]dimethylammonium acetate",67939-65-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3959a61c-e968-4510-a934-81f5e8618ab0/documents/c8bf762f-244d-4472-82c3-eec354ada7af_1f2718c4-cf6c-40c9-a8e7-c3cd5eda4af8.html,Chronic toxicity – systemic effects,oral,NOAEL,321.2 mg/kg bw/day,,rat "[4-[bis[4-(dimethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene]dimethylammonium acetate",67939-65-5," LD50 was estimated to be 922 mg/kg bw, when male and female CD-1 ICR mouse were exposed with  N-(4-{bis[4-(dimethylamino)phenyl]methylene}cyclohexa-2,5-dien-1-ylidene)-N-methylmethanaminium acetate (67939-65-5) orally. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3959a61c-e968-4510-a934-81f5e8618ab0/documents/fd503a69-07f9-49fb-9fa8-997b01b37f91_1f2718c4-cf6c-40c9-a8e7-c3cd5eda4af8.html,,,,,, "[4-[bis[4-(dimethylamino)phenyl]methylene]-2,5-cyclohexadien-1-ylidene]dimethylammonium acetate",67939-65-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3959a61c-e968-4510-a934-81f5e8618ab0/documents/fd503a69-07f9-49fb-9fa8-997b01b37f91_1f2718c4-cf6c-40c9-a8e7-c3cd5eda4af8.html,,oral,LD50,922 mg/kg bw,no adverse effect observed, "[4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate",65113-55-5," In the repeated dose toxicity studies (28 days and 90 days), the adverse effects observed where not specific enough and were not considered conclusive for classification for any specific target organ toxicity at repeated doses as no specific organs could be identified. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac0497e5-4a87-4d3f-b548-fee345b47cbf/documents/IUC5-1072a4b2-0c75-42e7-96db-d84a87b007a8_f3de1727-285f-4053-a22c-2432f232d4f7.html,,,,,, "[4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate",65113-55-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac0497e5-4a87-4d3f-b548-fee345b47cbf/documents/IUC5-1072a4b2-0c75-42e7-96db-d84a87b007a8_f3de1727-285f-4053-a22c-2432f232d4f7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,12.5 mg/kg bw/day,,rat "[4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate",65113-55-5," Based on the available oral and dermal acute toxicity studies, the Solvent Black 46 does not meet the criteria for classification. No inhalation acute toxicity study was performed since not exposure is expected during the manufacturing process or the use in the final product. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac0497e5-4a87-4d3f-b548-fee345b47cbf/documents/IUC5-707b0f93-e367-4a40-8bbe-202297a6701d_f3de1727-285f-4053-a22c-2432f232d4f7.html,,,,,, "[4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate",65113-55-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac0497e5-4a87-4d3f-b548-fee345b47cbf/documents/IUC5-707b0f93-e367-4a40-8bbe-202297a6701d_f3de1727-285f-4053-a22c-2432f232d4f7.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "[4-[p,p'-bis(dimethylamino)benzhydrylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium m-[[p-anilinophenyl]azo]benzenesulphonate",65113-55-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac0497e5-4a87-4d3f-b548-fee345b47cbf/documents/IUC5-707b0f93-e367-4a40-8bbe-202297a6701d_f3de1727-285f-4053-a22c-2432f232d4f7.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "[4-[α-[4-(dimethylamino)phenyl]benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate",41272-40-6, NOAEL = 7 mg/kg bw day ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/61ed98c2-1294-44e0-889d-019ac446774b/documents/IUC5-55f4ea81-5f13-46ec-bc75-bc6014abf2f7_f9bb0710-b98f-4477-b467-cadd15bc6cc5.html,,,,,, "[4-[α-[4-(dimethylamino)phenyl]benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate",41272-40-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/61ed98c2-1294-44e0-889d-019ac446774b/documents/IUC5-55f4ea81-5f13-46ec-bc75-bc6014abf2f7_f9bb0710-b98f-4477-b467-cadd15bc6cc5.html,Chronic toxicity – systemic effects,oral,NOAEL,7 mg/kg bw/day,,rat "[4-[α-[4-(dimethylamino)phenyl]benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate",41272-40-6, Oral toxicity: LD50 of 674 mg/kg (based on Malachite Green; salt form not specified) Dermal toxicity: LD0 of 2000 mg/kg b.w (based on Malachite Green Oxalate) Inhalatory exposure is unlikely ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61ed98c2-1294-44e0-889d-019ac446774b/documents/IUC5-71305672-716b-4cfb-b546-1a98a38a7419_f9bb0710-b98f-4477-b467-cadd15bc6cc5.html,,,,,, "[4-[α-[4-(dimethylamino)phenyl]benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate",41272-40-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61ed98c2-1294-44e0-889d-019ac446774b/documents/IUC5-71305672-716b-4cfb-b546-1a98a38a7419_f9bb0710-b98f-4477-b467-cadd15bc6cc5.html,,oral,LD50,674 mg/kg bw,adverse effect observed, "[4-[α-[4-(dimethylamino)phenyl]benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate",41272-40-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61ed98c2-1294-44e0-889d-019ac446774b/documents/IUC5-71305672-716b-4cfb-b546-1a98a38a7419_f9bb0710-b98f-4477-b467-cadd15bc6cc5.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "[7-hydroxy-8-[(4-sulpho-1-naphthyl)azo]naphthalene-1,3-disulphonato(3-)]aluminium",15876-47-8," Repeated dose toxicity: Oral Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound aluminium(3+) ion (5E)-6-oxo-5-[2-(4-sulfonatonaphthalen-1-yl)hydrazin- 1- ylidene]-5,6-dihydronaphthalene-1,3-disulfonate. The study assumed the use of male and female Wistar rats in a study of upto 28 days. No significant alterations were noted at the dose level of 525 mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for aluminium(3+) ion (5E)-6-oxo-5-[2-(4-sulfonatonaphthalen-1-yl)hydrazin-1-ylidene]-5,6-dihydronaphthalene-1,3-disulfonate is considered to be 525 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/1dbf3f85-9e94-409d-8329-4b49b0dbe86d/documents/4b95280c-f86b-4ff5-b9bd-f32196646cca_d8e5af08-1f0c-4154-b878-9d685e04c51c.html,,,,,, "[7-hydroxy-8-[(4-sulpho-1-naphthyl)azo]naphthalene-1,3-disulphonato(3-)]aluminium",15876-47-8,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/1dbf3f85-9e94-409d-8329-4b49b0dbe86d/documents/4b95280c-f86b-4ff5-b9bd-f32196646cca_d8e5af08-1f0c-4154-b878-9d685e04c51c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,525 mg/kg bw/day,,rat "[7-hydroxy-8-[(4-sulpho-1-naphthyl)azo]naphthalene-1,3-disulphonato(3-)]aluminium",15876-47-8," Acute oral toxicity:  LD50 was estimated to be 506 mg/kg bw when male and female Wistar rats were treated with [7-hydroxy-8-[(4-sulpho-1-naphthyl)azo]naphthalene-1,3-disulphonato(3-)]aluminium via oral gavage route. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1dbf3f85-9e94-409d-8329-4b49b0dbe86d/documents/c5b2d3a4-3016-4062-868c-16650b7f4d0a_d8e5af08-1f0c-4154-b878-9d685e04c51c.html,,,,,, "[7-hydroxy-8-[(4-sulpho-1-naphthyl)azo]naphthalene-1,3-disulphonato(3-)]aluminium",15876-47-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1dbf3f85-9e94-409d-8329-4b49b0dbe86d/documents/c5b2d3a4-3016-4062-868c-16650b7f4d0a_d8e5af08-1f0c-4154-b878-9d685e04c51c.html,,oral,LD50,506 mg/kg bw,adverse effect observed, "[cyclohexane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt",102506-09-2,"An oral LD50 value of >2000 mg/kg bw was reported for [cyclohexane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt in a reliable limit test conducted according to the now deleted OECD test guideline 401, and in compliance with GLP. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba81f064-1a73-4495-8a1e-3b4eb22bf6f4/documents/50cf64e9-24b0-4abf-ba87-9a452151fe35_671607ad-a769-4e28-bbd6-3cee736853ac.html,,,,,, "[cyclohexane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid, sodium salt",102506-09-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba81f064-1a73-4495-8a1e-3b4eb22bf6f4/documents/50cf64e9-24b0-4abf-ba87-9a452151fe35_671607ad-a769-4e28-bbd6-3cee736853ac.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "[ethane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid",1429-50-1," In a well conducted study male and female SD rats were administered EDTMP under (by gavage) resulted in neoplastic (osteosarcomas) and non neoplastic (metaphyseal osteosclerosis) effects which were related to the administration of the test substance. The non neoplastic effects (metaphyseal osteosclerosis) that were considered to be treatment related at the mid and high dose female group and high dose male group. NOAEL (female) = 15 mg/kg (bw), NOAEL (male) = 50 mg/kg (bw) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d08b74e-72f4-4658-8737-0823b400a37d/documents/a7e9e27b-0946-453f-b624-d55db5e1fa14_1bf86c7a-7eee-4ea0-b661-bf2165ebfb9a.html,,,,,, "[ethane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid",1429-50-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d08b74e-72f4-4658-8737-0823b400a37d/documents/a7e9e27b-0946-453f-b624-d55db5e1fa14_1bf86c7a-7eee-4ea0-b661-bf2165ebfb9a.html,Chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "[ethane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid",1429-50-1," An acute oral toxicity LD50 of 6900 mg/kg is reported in a report which was carried out according to a protocol similar to guideline but which pre-dated GLP (Younger Laboratories 1968). The sample was fed as a 25% solution-suspension in corn oil at 5010, 6310, 7940 and 10000 mg/kg, with necropsy findings of inflammation of the gastric mucosa and liver hyperemia. A reliable acute inhalation study conducted according to a protocol equivalent to current guideline reports an LC50 value of 4.60 mg/l (3.78-5.17 mg/l) of dust (Biodynamics 1980). The study was not compliant with GLP. An acute dermal LD50 value of >5010 mg/kg was reported in a study which was conducted according to an appropriate test protocol, but which pre-dated GLP. No real symptoms of acute toxicity were noted (Younger Laboratories 1968). The test material was administered as a 25% solution in corn oil at 501, 794, 1260, 2000, 3160, 5010 mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d08b74e-72f4-4658-8737-0823b400a37d/documents/b643fff3-852c-4cda-b494-4e32df64ffd1_1bf86c7a-7eee-4ea0-b661-bf2165ebfb9a.html,,,,,, "[ethane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid",1429-50-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d08b74e-72f4-4658-8737-0823b400a37d/documents/b643fff3-852c-4cda-b494-4e32df64ffd1_1bf86c7a-7eee-4ea0-b661-bf2165ebfb9a.html,,oral,LD50,"6,900 mg/kg bw",no adverse effect observed, "[ethane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid",1429-50-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d08b74e-72f4-4658-8737-0823b400a37d/documents/b643fff3-852c-4cda-b494-4e32df64ffd1_1bf86c7a-7eee-4ea0-b661-bf2165ebfb9a.html,,dermal,LD50,"5,010 mg/kg bw",no adverse effect observed, "[ethane-1,2-diylbis[nitrilobis(methylene)]]tetrakisphosphonic acid",1429-50-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d08b74e-72f4-4658-8737-0823b400a37d/documents/b643fff3-852c-4cda-b494-4e32df64ffd1_1bf86c7a-7eee-4ea0-b661-bf2165ebfb9a.html,,inhalation,LC50,"4,600 mg/m3",no adverse effect observed, "[ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, calcium sodium salt",85480-89-3,"Administration of EDTMP under the conditions of this study (by gavage) resulted in neoplastic (osteosarcomas) and nonneoplastic (metaphyseal osteosclerosis) effects which were related to the administration of the test substance. The non-neoplastic effects (metaphyseal osteosclerosis) were considered to be treatment related at the mid and high dose female group and high dose male group. NOAEL (female) = 15 mg/kg (bw), NOAEL (male) = 50 mg/kg (bw). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1df2074b-e64f-460d-acd1-c873afa1323d/documents/IUC5-8a60ff2e-aaf6-4812-a3e7-c5c6ebe130ce_281ea566-88e8-4b68-b136-c3f52db8fbdb.html,,,,,, "[ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, calcium sodium salt",85480-89-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1df2074b-e64f-460d-acd1-c873afa1323d/documents/IUC5-8a60ff2e-aaf6-4812-a3e7-c5c6ebe130ce_281ea566-88e8-4b68-b136-c3f52db8fbdb.html,Chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "[ethylenebis[nitrilobis(methylene)]]tetrakisphosphonic acid, calcium sodium salt",85480-89-3,"An acute oral LD50 value of >5000 mg/kg was reported in rat in a study which was carried out according to a protocol similar to current guideline (Hazleton Labs 1979a). The study was not GLP compliant and no necropsy of surviving animals was carried out.An acute inhalation LD50 of >4.17 mg/l (dust) was reported; this was the maximum achievable concentration (Inveresk 1980). The study was reliable and carried out according to a protocol similar to guideline, but not compliant with GLP. An acute dermal toxicity LD50 value of >5000 mg/kg was reported in a study carried out according to protocol comparable to current guideline, but not in compliance with GLP (Hazelton Labs, 1979a). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1df2074b-e64f-460d-acd1-c873afa1323d/documents/IUC5-c0abbe36-039a-42f2-adda-04c84d0bf077_281ea566-88e8-4b68-b136-c3f52db8fbdb.html,,,,,, "[iminobis(ethyleneiminomethylene)]bis(phosphonic) acid, N,N-bis(phosphonomethyl) derivative, sodium salt",68399-68-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Effects on bone density examined due to chelating / sequestinb effects ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6de8868e-d1d8-4c1b-b040-c35e357818f5/documents/IUC5-4cebcbf6-36d9-4fec-9144-77031e101a03_c1e12637-774b-41d3-a936-fc579cfd0cad.html,,,,,, "[iminobis(ethyleneiminomethylene)]bis(phosphonic) acid, N,N-bis(phosphonomethyl) derivative, sodium salt",68399-68-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6de8868e-d1d8-4c1b-b040-c35e357818f5/documents/IUC5-4cebcbf6-36d9-4fec-9144-77031e101a03_c1e12637-774b-41d3-a936-fc579cfd0cad.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "[iminobis(ethyleneiminomethylene)]bis(phosphonic) acid, N,N-bis(phosphonomethyl) derivative, sodium salt",68399-68-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): No adverse effects at limit of dosing ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6de8868e-d1d8-4c1b-b040-c35e357818f5/documents/IUC5-e682c567-330b-4207-8afe-2916c3ea273e_c1e12637-774b-41d3-a936-fc579cfd0cad.html,,,,,, "[iminobis(ethyleneiminomethylene)]bis(phosphonic) acid, N,N-bis(phosphonomethyl) derivative, sodium salt",68399-68-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6de8868e-d1d8-4c1b-b040-c35e357818f5/documents/IUC5-e682c567-330b-4207-8afe-2916c3ea273e_c1e12637-774b-41d3-a936-fc579cfd0cad.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper",28654-73-1,"In a reliable combined repeated dose and reproductive/developmental toxicity screening test (OECD TG 422) with the surrogate CAS number 75247-18-6 (read across approach, please refer to chapter 13 of the IUCLID, Assessment reports) by oral gavage in rats no toxicity occurred up to the highest administered dose of 1000 mg/kg bw/day. The NOAEL was determined to be 1000 mg/kg bw/day. No target organ was identified. Since the acute dermal toxicity study revealed a LD50 of > 2500 mg/kg bw in the absence of local clinical signs and the skin irritating study indicated no irritating effects, the repeated dose dermal toxicity can be considered as low when compared with oral exposure. The inhalation route is not of relevance due to the physico-chemical properties of the test item. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e7fba40-6be3-40df-ab3d-538d4c585656/documents/IUC5-5077f58b-10e9-420c-af9b-cd5349878bff_1d32f54f-1c00-4b3d-aa22-65817518e2a4.html,,,,,, "[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper",28654-73-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e7fba40-6be3-40df-ab3d-538d4c585656/documents/IUC5-5077f58b-10e9-420c-af9b-cd5349878bff_1d32f54f-1c00-4b3d-aa22-65817518e2a4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper",28654-73-1,"Since the results of the acute oral and dermal toxicity studies revealed a LD50 of > 10000 mg/kg bw and > 2500 mg/kg bw, respectively, it can be concluded that the test item has a low acute toxicity. Similar results were obtained in the acute inhalation toxicity study and by the administration via intraperitoneal injection. Thereby no mortality was observed and a LC0 of 0.68 mg/L (inhalation) and a LD50 of > 10000 mg/kg bw (intraperitoneal injection) was determined. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e7fba40-6be3-40df-ab3d-538d4c585656/documents/IUC5-a45af1ea-6051-4944-885c-9196d5e12e1d_1d32f54f-1c00-4b3d-aa22-65817518e2a4.html,,,,,, "[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper",28654-73-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e7fba40-6be3-40df-ab3d-538d4c585656/documents/IUC5-a45af1ea-6051-4944-885c-9196d5e12e1d_1d32f54f-1c00-4b3d-aa22-65817518e2a4.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper",28654-73-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e7fba40-6be3-40df-ab3d-538d4c585656/documents/IUC5-a45af1ea-6051-4944-885c-9196d5e12e1d_1d32f54f-1c00-4b3d-aa22-65817518e2a4.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper tris(dodecylbenzenesulphonate)",75247-18-6," In a reliable combined repeated dose and reproductive/developmental toxicity screening test with CAS number 75247-18-6 (OECD TG 422) by oral gavage in rats no toxicity occurred up to the highest administered dose of 1000 mg/kg bw/day. The NOAEL was determined to be 1000 mg/kg bw/day. No target organ was identified. Since the acute dermal toxicity study revealed a LD50 of > 2500 mg/kg bw (read-across from CAS no. 28654-73-1) in the absence of local clinical signs and the skin irritating study indicated no irritating effects, the repeated dose dermal toxicity can be considered as low when compared with oral exposure. The inhalation route is not of relevance due to the physico-chemical properties of the test item. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7357b373-6e89-4f9a-a405-a76f81b760e9/documents/IUC5-789d914a-8efd-41a3-89fd-702bb888355e_f682c6e0-df1a-44e0-90be-6f44c9506611.html,,,,,, "[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper tris(dodecylbenzenesulphonate)",75247-18-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7357b373-6e89-4f9a-a405-a76f81b760e9/documents/IUC5-789d914a-8efd-41a3-89fd-702bb888355e_f682c6e0-df1a-44e0-90be-6f44c9506611.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper tris(dodecylbenzenesulphonate)",75247-18-6," The substance caused no toxicity in rats upon single oral dosing of 10000 mg/kg bw (BASF AG, 1976). Based on key study results and experimental data with linear alkylbenzene sulfonate (LAS) salts, the CAS no. 75247-18-6 is considered to be of low acute dermal toxicity with a LD50 above 2000 mg/kg bw (BASF AG, 1976, read across from CAS number 28654-73-1 (for more details please refer to chapter 13 of the IUCLID, Assessment reports); SIAP, 2005). Similar results were obtained in the acute inhalation toxicity study (BASF AG, 1976). Thereby no mortality was observed (LC0: 13.35 mg/L) and no clinical signs appeared. In a study with mice (BASF AG, 1976) mortality occurred in all dose groups (1470, 2150, 3160 mg/kg bw) after intraperitoneal injection. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7357b373-6e89-4f9a-a405-a76f81b760e9/documents/IUC5-d6bd344a-203d-4471-a60b-6ede26a96a62_f682c6e0-df1a-44e0-90be-6f44c9506611.html,,,,,, "[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper tris(dodecylbenzenesulphonate)",75247-18-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7357b373-6e89-4f9a-a405-a76f81b760e9/documents/IUC5-d6bd344a-203d-4471-a60b-6ede26a96a62_f682c6e0-df1a-44e0-90be-6f44c9506611.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "[N,N,N',N',N'',N''-hexaethyl-29H,31H-phthalocyaninetrimethylaminato(2-)-N29,N30,N31,N32]copper tris(dodecylbenzenesulphonate)",75247-18-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7357b373-6e89-4f9a-a405-a76f81b760e9/documents/IUC5-d6bd344a-203d-4471-a60b-6ede26a96a62_f682c6e0-df1a-44e0-90be-6f44c9506611.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "[N,N',N''-tris[3-(dimethylamino)propyl]-29H,31H-phthalocyaninetrisulphonamidato(2-)-N29,N30,N31,N32]copper trihydrochloride",82864-58-2, LD50 > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/207c6aa5-1c12-4641-aa1a-4b2ae2476ccb/documents/c78e9a33-c60b-4f06-a463-4997ce5277f4_c82b26fb-aa43-43d7-a274-98382d2610fe.html,,,,,, "[N,N',N''-tris[3-(dimethylamino)propyl]-29H,31H-phthalocyaninetrisulphonamidato(2-)-N29,N30,N31,N32]copper trihydrochloride",82864-58-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/207c6aa5-1c12-4641-aa1a-4b2ae2476ccb/documents/c78e9a33-c60b-4f06-a463-4997ce5277f4_c82b26fb-aa43-43d7-a274-98382d2610fe.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "[N,N',N''-tris[3-(dimethylamino)propyl]-29H,31H-phthalocyaninetrisulphonamidato(2-)-N29,N30,N31,N32]copper trihydrochloride",82864-58-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/207c6aa5-1c12-4641-aa1a-4b2ae2476ccb/documents/c78e9a33-c60b-4f06-a463-4997ce5277f4_c82b26fb-aa43-43d7-a274-98382d2610fe.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, polymers with bisphenol A, epichlorohydrin and stearic acid",222716-77-0,"Combined Repeated Dose Oral (Gavage) Toxicity Study with the Reproduction/Developmental Toxicity Screening Test with WS400506 in rats to OECD 422:Doses / Study Design: 0 (vehicle control), 100, 300, 1000 mg/kg bw/day At least 5 animals/sex/dose were assigned to examination of each repeat dose toxicity parameter.Treatment period, toxicity subgroup animals: Daily, for five consecutive weeksSacrifice, all males and toxicity subgroup females: Week 6Effects considered to be adverse were evident at 1000 mg/kg/day in males. These comprised lymphatic ectasia in the mesenteric lymph node and cystic dilation of the central lymphatic or lacteal in the villi of the duodenum and jejunum associated with low bodyweight gain. In the absence of adverse effects on bodyweight in females, histopathology findings similar to those in males were not considered to be adverse. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0973b187-bf24-45b6-aaef-5bc56a7e9d02/documents/IUC5-6b6b55e6-17e3-4113-b6d2-f79f7d371b1a_baff92c6-af38-4c48-837b-6d98979335d8.html,,,,,, "Fatty acids, tall-oil, polymers with bisphenol A, epichlorohydrin and stearic acid",222716-77-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0973b187-bf24-45b6-aaef-5bc56a7e9d02/documents/IUC5-6b6b55e6-17e3-4113-b6d2-f79f7d371b1a_baff92c6-af38-4c48-837b-6d98979335d8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Fatty acids, tall-oil, polymers with bisphenol A, epichlorohydrin and stearic acid",222716-77-0,"Oral rat (standard acute method): LD50 > 8000 mg/kg bw (no mortality at 8000 mg/kg bw)Acute dermal rat: Waiving, as this study was considered to be scientifically unjustified. Acute inhalation rat: Exposure based waiving: Exposure of humans to WS400506 by the inhalation route is unlikely, because of its low vapour pressure and because of its wax like physical appearance with a freezing/pour point of only 30°C. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0973b187-bf24-45b6-aaef-5bc56a7e9d02/documents/IUC5-45704bdb-c78e-448b-bcbe-1a7c74945af6_baff92c6-af38-4c48-837b-6d98979335d8.html,,,,,, "[nitrilotris(methylene)]trisphosphonic acid, ammonium salt",34274-28-7," There are no repeated dose toxicity data for ATMP-xNH4, therefore data were read-across from ATMP-H. In a well-conducted key chronic toxicity/carcinogenicity study, ATMP-H (powder, 100% active acid) was administered via the diet to Long-Evans rats at dose levels of 50, 150 or 500 mg active acid/kg bw/day for 24 months. The NOAEL for carcinogenicity and general toxicity was at least 500 mg active acid/kg bw/day (BioDynamics Inc., 1979c). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51116d78-cb5f-4bc1-a160-8ab1da9eee10/documents/e0be1c6d-63fa-413e-823c-00b429b25d66_b3e35196-6f69-41d8-ad1b-975dec2d021b.html,,,,,, "[nitrilotris(methylene)]trisphosphonic acid, ammonium salt",34274-28-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51116d78-cb5f-4bc1-a160-8ab1da9eee10/documents/e0be1c6d-63fa-413e-823c-00b429b25d66_b3e35196-6f69-41d8-ad1b-975dec2d021b.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "[nitrilotris(methylene)]trisphosphonic acid, ammonium salt",34274-28-7," In the key acute oral toxicity study, conducted according to the now deleted OECD 401 but in compliance with GLP, the LD50 for the undiluted ammonium salt of ATMP was greater than 2000 mg/kg bw in rats (Safepharm Laboratories Ltd., 1995). In the key acute dermal toxicity study, conducted according to a protocol similar to OECD Test Guideline 402 and in compliance with GLP, the LD50 for ATMP-xNa (aqueous solution containing 41% w/w active salt) was concluded to be >10 ml/kg (equivalent to 5740 mg active salt/kg bw and 4437 mg active acid/ kg bw) in rats (SafePharm Laboratories, 1982c). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51116d78-cb5f-4bc1-a160-8ab1da9eee10/documents/d0809919-40fa-423a-ae0a-d7dea9fc7ce0_b3e35196-6f69-41d8-ad1b-975dec2d021b.html,,,,,, "[nitrilotris(methylene)]trisphosphonic acid, ammonium salt",34274-28-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51116d78-cb5f-4bc1-a160-8ab1da9eee10/documents/d0809919-40fa-423a-ae0a-d7dea9fc7ce0_b3e35196-6f69-41d8-ad1b-975dec2d021b.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "[nitrilotris(methylene)]trisphosphonic acid, ammonium salt",34274-28-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51116d78-cb5f-4bc1-a160-8ab1da9eee10/documents/d0809919-40fa-423a-ae0a-d7dea9fc7ce0_b3e35196-6f69-41d8-ad1b-975dec2d021b.html,,dermal,LD50,"4,437 mg/kg bw",no adverse effect observed, "[nitrilotris(methylene)]trisphosphonic acid, potassium salt",27794-93-0,"In read across data from a well conducted key chronic toxicity and carcinogenicity study (Biodynamics Inc, 1979c; rel 2), CP42902 (ATMP) was administered via the diet to Long-Evans rats at dose levels of 50, 150 or 500 mg/kg bw/day for 24 months. The NOAEL for carcinogenicity and general toxicity was greater than 500 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fb6314b-49cb-4cb2-af67-3d82b03fd322/documents/IUC5-2b57b847-b48d-41d1-b091-fb0abc19ae30_bc4a7d04-ed8e-4482-b8e1-e613835e2944.html,,,,,, "[nitrilotris(methylene)]trisphosphonic acid, potassium salt",27794-93-0,"The acute oral and dermal key studies were read across from the sodium salt (CAS 20592-85-2). T he key studies report an oral and dermal LD50 value of >10 ml/kg in rat (equivalent to >5740 mg active salt / kg bw) (Safepharm Labs, 1982; rel 1). The data for inhalation toxicity is waived as reliable data via the oral and dermal routes are available. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fb6314b-49cb-4cb2-af67-3d82b03fd322/documents/IUC5-4b5f53c0-9ca9-462c-82ea-7f57a37567fa_bc4a7d04-ed8e-4482-b8e1-e613835e2944.html,,,,,, "[nitrilotris(methylene)]trisphosphonic acid, potassium salt",27794-93-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fb6314b-49cb-4cb2-af67-3d82b03fd322/documents/IUC5-4b5f53c0-9ca9-462c-82ea-7f57a37567fa_bc4a7d04-ed8e-4482-b8e1-e613835e2944.html,,oral,LD50,"5,740 mg/kg bw",, "[nitrilotris(methylene)]trisphosphonic acid, potassium salt",27794-93-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fb6314b-49cb-4cb2-af67-3d82b03fd322/documents/IUC5-4b5f53c0-9ca9-462c-82ea-7f57a37567fa_bc4a7d04-ed8e-4482-b8e1-e613835e2944.html,,dermal,LD50,"5,740 mg/kg bw",, "[nitrilotris(methylene)]trisphosphonic acid, sodium salt",20592-85-2," There are no reliable repeated dose toxicity data for ATMP-xNa (CAS 20592-85-2, EC 243-900-0), therefore data were read-across from ATMP-H (CAS 6419 -19 -8; EC 229-146-5). In a well-conducted key chronic toxicity/carcinogenicity study, ATMP-H (powder, 100% active acid) was administered via the diet to Long-Evans rats at dose levels of 50, 150 or 500 mg active acid/kg bw/day for 24 months. The NOAEL for carcinogenicity and general toxicity was at least 500 mg active acid/kg bw/day (BioDynamics Inc., 1979c, Reliability 2). The key repeated dose toxicity study on DTPMP sodium salt is included in support of read-across of the reproductive toxicity study on DTPMP (5-7Na) only. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c23b0239-9a32-4efe-8339-1c8608a30596/documents/276717f5-ff15-4759-a564-03b3912c8242_43e6bfb5-1207-46d0-a465-7cbc3c3679d7.html,,,,,, "[nitrilotris(methylene)]trisphosphonic acid, sodium salt",20592-85-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c23b0239-9a32-4efe-8339-1c8608a30596/documents/276717f5-ff15-4759-a564-03b3912c8242_43e6bfb5-1207-46d0-a465-7cbc3c3679d7.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "[nitrilotris(methylene)]trisphosphonic acid, sodium salt",20592-85-2," In the key acute oral limit study, conducted according to the now-deleted OECD Test Guideline 401 and in compliance with GLP, the LD50 for ATMP-xNa (CAS 20592-85-2; EC 243-900-0; aqueous solution containing 41% w/w active salt) was concluded to be ≥10 ml/kg (equivalent to 5740 mg active salt/kg bw and 4437 mg active acid/kg bw) in rats (SafePharm Laboratories, 1982a, Reliability 1). In the key acute dermal toxicity study, conducted according to a protocol similar to OECD Test Guideline 402 and in compliance with GLP, the LD50 for ATMP-xNa (aqueous solution containing 41% w/w active salt) was concluded to be >10 ml/kg (equivalent to 5740 mg active salt/kg bw and 4437 mg active acid/kg bw) in rats (SafePharm Laboratories, 1982c, Reliability 1). Key acute toxicity studies on ATMP-H are included in support of read-across of the reproductive toxicity study on DTPMP (5-7Na) only. Key acute toxicity studies on DTPMP acid and sodium salts are included in support of read-across of the reproductive toxicity study on DTPMP (5-7Na) only. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c23b0239-9a32-4efe-8339-1c8608a30596/documents/9d54a732-afe5-4fee-a42f-d43e6b1a2ded_43e6bfb5-1207-46d0-a465-7cbc3c3679d7.html,,,,,, "[nitrilotris(methylene)]trisphosphonic acid, sodium salt",20592-85-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c23b0239-9a32-4efe-8339-1c8608a30596/documents/9d54a732-afe5-4fee-a42f-d43e6b1a2ded_43e6bfb5-1207-46d0-a465-7cbc3c3679d7.html,,oral,LD50,"4,437 mg/kg bw",no adverse effect observed, "[nitrilotris(methylene)]trisphosphonic acid, sodium salt",20592-85-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c23b0239-9a32-4efe-8339-1c8608a30596/documents/9d54a732-afe5-4fee-a42f-d43e6b1a2ded_43e6bfb5-1207-46d0-a465-7cbc3c3679d7.html,,dermal,LD50,"4,437 mg/kg bw",no adverse effect observed, 1-(3-bicyclo[2.2.1]heptanyl)hex-5-en-2-one,1352216-91-1," Oral LD50 Females > 2000 mg kg bw (OECD 420, GLP, K, rel.1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbeb3a97-9545-4319-bf68-9b3e6f31c269/documents/959b35c4-3a22-40c5-ab72-088526bbc081_488fc32a-08e3-46d4-bcce-1a8c04883c5d.html,,,,,, 1-(3-bicyclo[2.2.1]heptanyl)hex-5-en-2-one,1352216-91-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbeb3a97-9545-4319-bf68-9b3e6f31c269/documents/959b35c4-3a22-40c5-ab72-088526bbc081_488fc32a-08e3-46d4-bcce-1a8c04883c5d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "potassium (trans-4-(methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino)-cyclohexyl)-methanesulfonate",2124221-14-1,"Refer to the OECD Guideline 407, a repeated Dose 28-Day Oral Toxicity Study in Sprague Dawley rats with D4 was performed. The no-adverse-observed-effect-level (NOAEL) for D4 in the repeated dose 28-day oral toxicity study in SD rats under the condition of the study was considered to be 1000 mg/kg body weight/day for both sexes, there were no effects of treatment at this dose. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e340dfd6-3f2d-43a9-a341-a84756d20dc0/documents/bd4f7395-4747-4dca-ae60-d54137949e8b_73fc29d0-bf48-4e51-aa6b-faa15dc19c54.html,,,,,, "potassium (trans-4-(methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino)-cyclohexyl)-methanesulfonate",2124221-14-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e340dfd6-3f2d-43a9-a341-a84756d20dc0/documents/bd4f7395-4747-4dca-ae60-d54137949e8b_73fc29d0-bf48-4e51-aa6b-faa15dc19c54.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "potassium (trans-4-(methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino)-cyclohexyl)-methanesulfonate",2124221-14-1,The oral LD50 of the test item is greater than 2000 mg/kg of body weight in female rats. The acute dermal LD50 in rats for D4 was estimated to be more than 2000 mg/kg b.w. in female SD rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e340dfd6-3f2d-43a9-a341-a84756d20dc0/documents/cf930c8b-51eb-45d9-8b1a-185f66a22cac_73fc29d0-bf48-4e51-aa6b-faa15dc19c54.html,,,,,, "potassium (trans-4-(methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino)-cyclohexyl)-methanesulfonate",2124221-14-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e340dfd6-3f2d-43a9-a341-a84756d20dc0/documents/cf930c8b-51eb-45d9-8b1a-185f66a22cac_73fc29d0-bf48-4e51-aa6b-faa15dc19c54.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "potassium (trans-4-(methyl-(7H-pyrrolo[2,3-d]pyrimidin-4-yl)-amino)-cyclohexyl)-methanesulfonate",2124221-14-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e340dfd6-3f2d-43a9-a341-a84756d20dc0/documents/cf930c8b-51eb-45d9-8b1a-185f66a22cac_73fc29d0-bf48-4e51-aa6b-faa15dc19c54.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Santalol oil: fermentation products of glucose with santalene synthase modified Rhodobacter sphaeroides, distilled, oxidised",2576531-09-2, Acute oral toxicity (OECD TG 423 Acute Toxic Class Method; GLP): LD50 > 2000 mg/kg bw (BASF SE 2021; 10A0281/20X062). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c227a29-564c-47c8-8ada-846efebf44ac/documents/d9b40530-4b4b-43ec-b019-b38fc5840ea1_8638ae28-1f01-49a7-97ef-87fd40421ff0.html,,,,,, 1-Ethyl-3-methylimidazolium ethylsulfate,342573-75-5,"- Repeated dose toxicity, oral exposure: OECD TG 407 (NOTOX B.V, 2005) and OECD TG 408 (BASF SE, 2011); both in rats (Val 1); NOAEL= 1000 mg/kg bw/d;- Repeated dose toxicity, dermal exposure: no data available;- Repeated dose toxicity, inhalation exposure: no data available ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c56496ae-d39d-4bee-a01a-b6ab3da74860/documents/IUC5-b4621ea9-7f8b-4d92-8ded-019fb8242d25_f41203c3-11ea-4674-9493-f2059d5798be.html,,,,,, 1-Ethyl-3-methylimidazolium ethylsulfate,342573-75-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c56496ae-d39d-4bee-a01a-b6ab3da74860/documents/IUC5-b4621ea9-7f8b-4d92-8ded-019fb8242d25_f41203c3-11ea-4674-9493-f2059d5798be.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 1-Ethyl-3-methylimidazolium ethylsulfate,342573-75-5,Acute oral: LD 50 > 2000 mg/kg bw (OECD 423)Acute dermal: LD 50 > 2000 mg/kg bw (OECD 402) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c56496ae-d39d-4bee-a01a-b6ab3da74860/documents/IUC5-147d4579-1219-4749-9b08-4c8411266909_f41203c3-11ea-4674-9493-f2059d5798be.html,,,,,, "tert-butyl 5'-acetyl-3'H-spiro[azetidine-3,1'-isobenzofuran]-1-carboxylate",1398609-81-8,"Oral: The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat according to OECD 423. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg body weight.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): 1 (reliable without restriction) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/705ef98e-67b2-4154-a60c-2aea88e3fccd/documents/4246f12d-4b06-43b8-9425-9aecf10b230c_e257e175-ffaf-4627-8859-162cc056a7ca.html,,,,,, "tert-butyl 5'-acetyl-3'H-spiro[azetidine-3,1'-isobenzofuran]-1-carboxylate",1398609-81-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/705ef98e-67b2-4154-a60c-2aea88e3fccd/documents/4246f12d-4b06-43b8-9425-9aecf10b230c_e257e175-ffaf-4627-8859-162cc056a7ca.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, 4-hydroxy-3-methylbenzenesulphonic acid,7134-04-5,"Acute oral toxicity, OECD 423, Van Erp (2021): LD50: 500 mg/kg bw, Acute Oral Toxicity Cat. 4 (H302) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): A Klimisch rating of 1 has been applied. The study is conducted to the relevant OECD test guideline and in accordance with GLP, therefore reliably fulfilling the endpoint requirement. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): NA Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): NA ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7691522-90a0-4846-be36-ffdd3d7e8c58/documents/1ac5d770-802d-4514-9323-4b0283456441_03914957-3c6d-4bc1-883e-5f8322c1fb2f.html,,,,,, 4-hydroxy-3-methylbenzenesulphonic acid,7134-04-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7691522-90a0-4846-be36-ffdd3d7e8c58/documents/1ac5d770-802d-4514-9323-4b0283456441_03914957-3c6d-4bc1-883e-5f8322c1fb2f.html,,oral,LD50,500 mg/kg bw,adverse effect observed, (E)-1-methoxy-4-(3-phenylprop-1-en-1-yl)benzene,35856-81-6,"The read-across from the two source substances is considered to give a reliable estimation of the acute oral toxicity potential of the target substance. Both source substances are found to have an LD50oral >2000 mg/kg bw and >16000 mg/kg bw, respectively.The LD50 oral of 9000 mg/kg bw in the read-across study has been estimated for hazard classification and chemical safety assessment. In conclusion, a LD50oral >2000 mg/kg bw is taken for the target substance.According to the LD50 values described above, both analogues and the target substance are associated with the same GHS/CLP classification (not classified). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f9cf419-e825-40dc-a891-b9d609fd0033/documents/b3e97003-9e3a-4335-b8d2-4cf8155f1a5d_c3c21b29-92b1-410f-86d0-48515dccfe5d.html,,,,,, (E)-1-methoxy-4-(3-phenylprop-1-en-1-yl)benzene,35856-81-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f9cf419-e825-40dc-a891-b9d609fd0033/documents/b3e97003-9e3a-4335-b8d2-4cf8155f1a5d_c3c21b29-92b1-410f-86d0-48515dccfe5d.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "bis(2,2,6,6-tetramethyl-1-(1,3-benzothiazol-2-ylsulfanyl)piperidin-4-yl)carbonate",2311845-49-3,"Acute oral toxicity OECD 423, rat, acute toxic class method, LD50 > 2000 mg/kg bw Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): OECD guideline study under GLP compliance ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd0ecdaf-0f06-495d-8905-0b6b4aa3a81f/documents/2a4cee2e-fedd-4ef7-aa10-9d6f9fd0384e_1ba02708-1c9b-464b-9ce7-310a7b047cd1.html,,,,,, "bis(2,2,6,6-tetramethyl-1-(1,3-benzothiazol-2-ylsulfanyl)piperidin-4-yl)carbonate",2311845-49-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd0ecdaf-0f06-495d-8905-0b6b4aa3a81f/documents/2a4cee2e-fedd-4ef7-aa10-9d6f9fd0384e_1ba02708-1c9b-464b-9ce7-310a7b047cd1.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, [No public or meaningful name is available],474266-68-7,no data ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32344b47-956b-4698-96be-5b08b67f3b97/documents/IUC5-83ffe0ef-f2b1-499a-b536-f4663c2562b7_de36922c-a001-4847-a95c-cd300b9a7720.html,,,,,, [No public or meaningful name is available],474266-68-7,DIBN is instable under normal conditions and testing is not feasible due to technical reasons according REACH Regulation (EC) no 1907_2006 Annex XI.However 2 studies concerning acute oral and dermale toxicity with a mixture of approx. 20% diisobutylene nitrosate and approx. 80% diisobutylene are available as secondary literature ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32344b47-956b-4698-96be-5b08b67f3b97/documents/IUC5-29ba64e8-25e1-4445-adef-1c99815a26c8_de36922c-a001-4847-a95c-cd300b9a7720.html,,,,,, "Zinc bis[(1Z)-3-oxo-1,3-diphenyl-1-propen-1-olate]",21333-45-9,Oral: LD50 (m/f) > 2000 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6ada4d7-ab5c-4e2d-b71d-b8f261571ab1/documents/36b13db2-a796-4ba0-b907-b8fc1b4be818_f94c4b90-9fea-4db5-91eb-3e8e7e889870.html,,,,,, "Zinc bis[(1Z)-3-oxo-1,3-diphenyl-1-propen-1-olate]",21333-45-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6ada4d7-ab5c-4e2d-b71d-b8f261571ab1/documents/36b13db2-a796-4ba0-b907-b8fc1b4be818_f94c4b90-9fea-4db5-91eb-3e8e7e889870.html,,oral,LD50,"> 2,000 ",no adverse effect observed, "reaction products of benzaldehyde diethylenetriamine and triethylenetetramine, hydrogenated",1219458-07-7,"7 day study In a preliminary 7 day- DRF study with Wistar rats, the tested dose levels were 0, 125, 250 and 500 mg/kg bw/d. The aim of this study was to determine suitable dose levels for the oral 28 day repeated dose toxicity study. The results indicated severe toxicological effects in the highest dose groups such as increased mortality and severe clinical effects (prostration, piloerection, lethargy, hypothermia, hunched posture, loss of righting reflex and laboured respiration) and decreased body weight. Macroscopic examinations revealed a mottled appearance of the liver in all animals, and the liver of two animals also appeared dark. In the stomach of all animals, a gaseous distension was found with the non-glandular region appearing thin and the lung of two animals were reddened. In the 250 mg/kg dose group also severe clinical effects occurred mainly in male animals such as lethargy, hunched posture, increased respiration rate and staining around snout and further notable body weight loss between Days 5-7. Based on these effects one male animal was subsequently killed on Day 7. Female rats were found to be less sensitive to the test material. Based on the results of this study, the high dosage for more long-term investigation of toxicity in male and female rats should not be much higher than 125 mg/kg bw/day (Envigo, 2018). In the subsequently performed 28d oral repeated dose toxicity study with male and female Wistar Han™:RccHan™:WIST rats, no adverse treatment related changes were observed at dose levels of 30, 75 and 150 mg/kg bw/day. The No Observed Adverse Effect Level (NOAEL) was considered to be 150 mg/kg bw/day.   28 day study In the 28 day study, the test item was administered by gavage to three groups, each of five male and five female Wistar Han™:RccHan™:WIST strain rats, for up to twenty-eight consecutive days, at dose levels of 30, 75 and 150 mg/kg bw/day. A control group of five males and five females was dosed with vehicle alone (Polyethylene glycol 400). Clinical signs, functional observations, body weight change, dietary intake and water consumption were monitored during the study. Hematology and blood chemistry were evaluated for all animals at the end of the study. All animals were subjected to gross necropsy examination and histopathological evaluation of selected tissues from high dose and control animals was performed. One female dosed with 75 mg/kg bw/day was found dead and cannibalized on Day 9 relative to the start of dosing. No clinical signs had been apparent for this animal prior to this event. Necropsy findings revealed a tear in the esophagus and therefore this death was considered to be due to trauma during the dosing procedure, and not related to the administration of test item. Oral administration of Benzylated polyamine to male and female Wistar Han™:RccHan™:WIST strain rats for up to twenty-eight consecutive days at dose levels of 30, 75 and 150 mg/kg bw/day resulted in no adverse treatment related changes. The No Observed Adverse Effect Level (NOAEL) was considered to be 150 mg/kg bw/day.   90 day study In the 90 day study, the test item was administered by gavage to three groups, each of ten male and ten female Wistar rats for up to 90 consecutive days, at dose levels of 15, 30 and 100 mg/kg bw/day. A control group of ten males and ten females was dosed with vehicle alone (Corn oil). In addition, 5 male and 5 female animals per control and high dose (HD) group were dosed for assessment of recovery from toxic effects. One male of the HD group and one male of the mid dose group were found dead on treatment day 41 and 10, respectively.  The cause of death of the MD animal was most likely related to trauma in the thoracic cavity that occurred during gavage procedure. For the HD animal the cause of death could not be determined based on the histopathological evaluation of organs and tissues but it showed a dark red coloured lung at necropsy and abnormal breathing on the day of death, thus the cause of death is most likely related to a tolerability of the dosage formulation or gavage procedure (e.g., regurgitation and aspiration of the dosage formulation in the lung). No adverse test item-related effects were found in males and females of the dose groups on mortality, clinical observations, functional observations, body weight, food consumption, hormone analysis, haematology and coagulation, urinalysis, macroscopic findings at necropsy and organ weights. The test item showed an adverse effect on the clinical biochemistry parameter ASAT in the male HD group at the end of the treatment period. Histopathological evaluation showed adverse skeletal muscle fiber degeneration in male animals, which recovered after a period of 28 days. This finding reflects systemic exposure of the test item with transient effect and was considered to be adverse in the male HD group and correlates with the increase of ASAT in the male HD group. The no observed adverse effect level (NOAEL) was considered to be 30 mg/kg body weight/day (mid dose). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/068a2c6a-ea7c-469f-8edb-98e31e805eb3/documents/646aa16c-256d-440a-89ee-029e0ea2e295_67bb1506-97d6-42eb-a253-d0c164876d96.html,,,,,, "reaction products of benzaldehyde diethylenetriamine and triethylenetetramine, hydrogenated",1219458-07-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/068a2c6a-ea7c-469f-8edb-98e31e805eb3/documents/646aa16c-256d-440a-89ee-029e0ea2e295_67bb1506-97d6-42eb-a253-d0c164876d96.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,, "reaction products of benzaldehyde diethylenetriamine and triethylenetetramine, hydrogenated",1219458-07-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/068a2c6a-ea7c-469f-8edb-98e31e805eb3/documents/646aa16c-256d-440a-89ee-029e0ea2e295_67bb1506-97d6-42eb-a253-d0c164876d96.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "reaction products of benzaldehyde diethylenetriamine and triethylenetetramine, hydrogenated",1219458-07-7,The oral acute toxicity of the test material was determined in an acute oral toxicity test according to OECD 423 (MB Research 2017). The LD50 value was between >=300 mg/kg and <=2000 mg/kg bw.   ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/068a2c6a-ea7c-469f-8edb-98e31e805eb3/documents/c4b4ef26-756d-439b-8c9e-f12a5566400a_67bb1506-97d6-42eb-a253-d0c164876d96.html,,,,,, "reaction products of benzaldehyde diethylenetriamine and triethylenetetramine, hydrogenated",1219458-07-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/068a2c6a-ea7c-469f-8edb-98e31e805eb3/documents/c4b4ef26-756d-439b-8c9e-f12a5566400a_67bb1506-97d6-42eb-a253-d0c164876d96.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "2,5-Dimethoxypyridine-4-boronic acid",1630193-77-9,"Acute toxicity: oral (rats, OECD TG 423): LD50: 300 < LD50 ≤ 2000 mg/kg bw The study was performed to asses the acute oral toxicity of the test item in female SD rats according to the OECD guideline 423.The single oral administration of the test substance to the rats at a dose of 300 mg/kg bw was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. The rats treated with the dose of 2000 mg/kg bw died on day 1 after dosing. The LD50 acute oral toxicity in female SD rats was estimated to be 300 < LD50 ≤ 2000 mg/kg bw.   Acute toxicity: dermal (rats, OECD TG 402): LD50: > 2000 mg/kg bw The study was performed to asses the acute dermal toxicity of the test item in female SD rats according to the OECD guideline 402.The single dermal administration of the test substance to the rats at a dose of 2000 mg/kg bw was tolerated without any mortality or compound-related clinical or macroscopic pathological signs.The LD50 acute dermal toxicity in female SD rats was estimated to be > 2000 mg/kg bw.   Acute toxicity: inhalation (rats, OECD TG 436): 530 < LC50 < 5270.5 mg/m³ The study was designed according to OECD 436 to assess the acute inhalation toxicity of the test item after being nose-only administrated to SD rats for 4 hours and to serve as a basis for classification and labelling. Based on the results, the acute inhalation LC50 in SD rats for the test item in 4 hours exposure period is 530 < LC50 < 5270.5 mg/m³, and the cut off LC50 was estimated to be 1000 mg/m³. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6f2cada-d76a-48c6-a2e4-d09d535194d4/documents/d013ec87-bf42-4db7-9dac-4ccff4422bb9_d340d7a5-f7e7-48f5-aac8-e41fc9c31b07.html,,,,,, "2,5-Dimethoxypyridine-4-boronic acid",1630193-77-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6f2cada-d76a-48c6-a2e4-d09d535194d4/documents/d013ec87-bf42-4db7-9dac-4ccff4422bb9_d340d7a5-f7e7-48f5-aac8-e41fc9c31b07.html,,oral,LD50,"< 2,000 mg/kg bw",adverse effect observed, "2,5-Dimethoxypyridine-4-boronic acid",1630193-77-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6f2cada-d76a-48c6-a2e4-d09d535194d4/documents/d013ec87-bf42-4db7-9dac-4ccff4422bb9_d340d7a5-f7e7-48f5-aac8-e41fc9c31b07.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,5-Dimethoxypyridine-4-boronic acid",1630193-77-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6f2cada-d76a-48c6-a2e4-d09d535194d4/documents/d013ec87-bf42-4db7-9dac-4ccff4422bb9_d340d7a5-f7e7-48f5-aac8-e41fc9c31b07.html,,inhalation,LC50,"< 1,000 mg/m3",adverse effect observed, "Silicic acid (H6Si2O7), ytterbium(3+) salt (1:2)",13692-83-6, The oral LD50 in Wistar rats was demonstrated to be greater than 2000 mg/kg body weight. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/016186b8-2259-4eb3-8eb4-f001fab5f90e/documents/abc1dc35-7e25-4f83-86be-4ee963ee9ccb_0b52f66f-a106-4435-a7aa-34786e7eb353.html,,,,,, "Silicic acid (H6Si2O7), ytterbium(3+) salt (1:2)",13692-83-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/016186b8-2259-4eb3-8eb4-f001fab5f90e/documents/abc1dc35-7e25-4f83-86be-4ee963ee9ccb_0b52f66f-a106-4435-a7aa-34786e7eb353.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(S)-tert-butyl 5'-(5-(3,5-dichloro-4-fluorophenyl)-5-(trifluoromethyl)-4,5-dihydroisoxazol-3-yl)-3'H-spiro[azetidine-3,1'-isobenzofuran]-1-carboxylate",1398610-06-4,"Oral: The oral LD50 value of test item in Wistar Han rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. Dermal: No data available Inhalation: No data available Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): 1 (reliable without restrictions) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d356d6cc-6b9d-4829-bdd5-002de8523288/documents/72183b96-9dec-400a-9958-d8781bdaa0bc_b02c5ce4-7844-4c34-bf70-3792625d6203.html,,,,,, "(S)-tert-butyl 5'-(5-(3,5-dichloro-4-fluorophenyl)-5-(trifluoromethyl)-4,5-dihydroisoxazol-3-yl)-3'H-spiro[azetidine-3,1'-isobenzofuran]-1-carboxylate",1398610-06-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d356d6cc-6b9d-4829-bdd5-002de8523288/documents/72183b96-9dec-400a-9958-d8781bdaa0bc_b02c5ce4-7844-4c34-bf70-3792625d6203.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, N-(4-((4-(3-phenylureido)phenyl)sulfonyl)phenyl)benzenesulfonamide,2437256-84-1," In an acute oral toxicity study (OECD TG 423) with N-(4-((4-(3-phenylureido)phenyl)sulfonyl)phenyl)-benzenesulfonamide, no mortality was observed. The LD50 can be considered to be >2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e356ce3-22dd-4309-a524-8cc514b6c3f9/documents/cc2da008-4eb1-4964-9b8f-cdb17ed1b5dd_2047c8bf-1f6d-4632-ad7d-87d3542025be.html,,,,,, N-(4-((4-(3-phenylureido)phenyl)sulfonyl)phenyl)benzenesulfonamide,2437256-84-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e356ce3-22dd-4309-a524-8cc514b6c3f9/documents/cc2da008-4eb1-4964-9b8f-cdb17ed1b5dd_2047c8bf-1f6d-4632-ad7d-87d3542025be.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Corn gluten, hydrolyzate",639814-42-9,"Performed repeated dose toxicity studies were conducted for the safety evaluation of potential use of protein hydrolysates as dietary supplements with expected relatively high daily uptake. Because proteins, which are further hydrolysed in the gastrointestinal tract are a natural component of the diet no adverse effects were expected.  Indeed protein hydrolysates are widely used as food supplement in human died and no toxic effects are observed. In human diets these products, including bioactive peptides, are often used as ingredients in specific nutritional products, such as hypoallergenic infant formulas and functional foods, such as sports beverages. Various traditional protein sources, including milk, fish, meat, collagen, egg, pea, soy, rice and potato are being used for the preparation of protein hydrolysates (Schaafsma 2009). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d590b68-25f0-43a0-8319-7789dc22e19e/documents/dddf49c5-e578-4f21-9f8c-2a7f3c83ac13_4a399728-445c-4993-b0ac-32e3654ce51c.html,,,,,, "(2Z)-4,8-dimethylnona-2,7-dien-4-ol",89929-57-7," Repeated dose toxicity oral: NOAEL = 1000 mg/kg bw/d (OECD 407, GLP, K, rel. 1) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce64b372-41b2-458e-83ce-821960ccfd89/documents/0e688711-03da-47e1-990d-da79b6d334dc_f2dd1fea-0002-4d81-a482-3b59da955405.html,,,,,, "(2Z)-4,8-dimethylnona-2,7-dien-4-ol",89929-57-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce64b372-41b2-458e-83ce-821960ccfd89/documents/0e688711-03da-47e1-990d-da79b6d334dc_f2dd1fea-0002-4d81-a482-3b59da955405.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "(2Z)-4,8-dimethylnona-2,7-dien-4-ol",89929-57-7," Oral LD50 (Females) > 2000 mg/kg bw (OECD 423, K, Rel.1, class method in rats) Dermal LD50 (Combined) > 2000 mg/kg bw (OECD 402, K, Rel.1, limit test in rats) Inhalation LC50 (Females) = 4.84 mg/L (= 4840 mg/m3) (OECD 403, K, Rel.1, nose-only in rats) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce64b372-41b2-458e-83ce-821960ccfd89/documents/07860bfb-3bbf-4bb9-a369-a34297d63e51_f2dd1fea-0002-4d81-a482-3b59da955405.html,,,,,, "(2Z)-4,8-dimethylnona-2,7-dien-4-ol",89929-57-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce64b372-41b2-458e-83ce-821960ccfd89/documents/07860bfb-3bbf-4bb9-a369-a34297d63e51_f2dd1fea-0002-4d81-a482-3b59da955405.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(2Z)-4,8-dimethylnona-2,7-dien-4-ol",89929-57-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce64b372-41b2-458e-83ce-821960ccfd89/documents/07860bfb-3bbf-4bb9-a369-a34297d63e51_f2dd1fea-0002-4d81-a482-3b59da955405.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "(2Z)-4,8-dimethylnona-2,7-dien-4-ol",89929-57-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce64b372-41b2-458e-83ce-821960ccfd89/documents/07860bfb-3bbf-4bb9-a369-a34297d63e51_f2dd1fea-0002-4d81-a482-3b59da955405.html,,inhalation,LC50,"4,840 mg/m3",adverse effect observed, "(2R,2'R)-3,3'-disulfanediylbis(2-((S)-2-aminopropanamido)propanoic acid)",115888-13-6," The acute oral toxicity of N,N´-di-L-Alanyl-L-Cystine / (L-Ala-L-Cys)2 was tested in a study performed according to OECD TG 423. The oral LD50 value was established to exceed 2000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f7fa6ce-3929-4ae1-b3df-873f907f398c/documents/d5740d72-403a-4335-90dd-ca58079b2deb_162e7617-010b-4e84-a288-b2a752b1bbc4.html,,,,,, "(2R,2'R)-3,3'-disulfanediylbis(2-((S)-2-aminopropanamido)propanoic acid)",115888-13-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f7fa6ce-3929-4ae1-b3df-873f907f398c/documents/d5740d72-403a-4335-90dd-ca58079b2deb_162e7617-010b-4e84-a288-b2a752b1bbc4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1,1,3,3,3-Hexafluoropropane",690-39-1,Subchronic NOAEC (rat): 124000 mg/m3 (other guideline; GLP) ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/537ecfdd-a0ee-4f62-8332-e38dfdb49ded/documents/IUC5-61fadcd9-508c-4103-ac6f-69c06a9fe6c3_000e56f1-e16b-4927-a4c0-59b039fc7e67.html,,,,,, "1,1,1,3,3,3-Hexafluoropropane",690-39-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/537ecfdd-a0ee-4f62-8332-e38dfdb49ded/documents/IUC5-61fadcd9-508c-4103-ac6f-69c06a9fe6c3_000e56f1-e16b-4927-a4c0-59b039fc7e67.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"124,000 mg/m3",,rat "1,1,1,3,3,3-Hexafluoropropane",690-39-1,Acute Inhalation Toxicity: LC50=>2833400 mg/m³ (OECD 403; GLP) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/537ecfdd-a0ee-4f62-8332-e38dfdb49ded/documents/IUC5-013cb195-9362-4cee-a283-655197a70154_000e56f1-e16b-4927-a4c0-59b039fc7e67.html,,,,,, "1,1,1,3,3,3-Hexafluoropropane",690-39-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/537ecfdd-a0ee-4f62-8332-e38dfdb49ded/documents/IUC5-013cb195-9362-4cee-a283-655197a70154_000e56f1-e16b-4927-a4c0-59b039fc7e67.html,,inhalation,LC50,"2,833,400 mg/m3",adverse effect observed, "(S)-5'-(5-(3,5-dichloro-4-fluorophenyl)-5-(trifluoromethyl)-4,5-dihydroisoxazol-3-yl)-3'H-spiro[azetidine-3,1'-isobenzofuran]-1-ium benzenesulfonate",2097130-30-6,Oral: Read across from Sarolaner API Test article was evaluated for its acute oral toxicity potential in female albino rats when administered as a gavage dose by OECD 425. The acute oral LD50 was estimated to be 783 mg/kg. Dermal: No data available Inhalation: No data available ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/914e7a13-2abf-4600-b72f-cbf51db5ab24/documents/f0a2ecd8-366e-44a6-90e4-be3705417f31_54bc9219-fb44-45e1-a1ec-34924676af79.html,,,,,, "(S)-5'-(5-(3,5-dichloro-4-fluorophenyl)-5-(trifluoromethyl)-4,5-dihydroisoxazol-3-yl)-3'H-spiro[azetidine-3,1'-isobenzofuran]-1-ium benzenesulfonate",2097130-30-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/914e7a13-2abf-4600-b72f-cbf51db5ab24/documents/f0a2ecd8-366e-44a6-90e4-be3705417f31_54bc9219-fb44-45e1-a1ec-34924676af79.html,,oral,LD50,783 mg/kg bw,no adverse effect observed, "N-methyl-1-(trans-4-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclohexyl)methanesulfonamide",1208319-26-9,"Oral: The acute oral study is performed according to OECD Guideline 425 under GLP. The oral LD50 of the test item when administered to female rats is estimated to be 310.2 mg/kg.   Dermal: The acute dermal study is performed according to OECD Guideline 402 under GLP. The dermal LD50 of the test item was greater than 2000 mg/kg in male and female rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable without restrictions Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): reliable without restrictions ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eae49331-7aac-4b52-b237-880687e9c3d3/documents/be11df7c-2449-482a-8f03-b325f0a00bb8_1a51475a-166b-4b29-8ed6-55b38b3aa0d8.html,,,,,, "N-methyl-1-(trans-4-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclohexyl)methanesulfonamide",1208319-26-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eae49331-7aac-4b52-b237-880687e9c3d3/documents/be11df7c-2449-482a-8f03-b325f0a00bb8_1a51475a-166b-4b29-8ed6-55b38b3aa0d8.html,,oral,LD50,310.2 mg/kg bw,adverse effect observed, "N-methyl-1-(trans-4-(methyl(7H-pyrrolo[2,3-d]pyrimidin-4-yl)amino)cyclohexyl)methanesulfonamide",1208319-26-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eae49331-7aac-4b52-b237-880687e9c3d3/documents/be11df7c-2449-482a-8f03-b325f0a00bb8_1a51475a-166b-4b29-8ed6-55b38b3aa0d8.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Phosphonic acid, (4-morpholinylmethylene)bis-, tetraethyl ester",59646-46-7,"One acute toxicity study via oral route according to OECD 423; EC 440/2008, Method B.1 tris; OPPTS 870.1100 (GLP, Klimisch 1) was performed with the test item in rats. Under the conditions of the study, a single oral application of the test item to rats at a dose of 300 mg/kg body weight was associated with signs of toxicity but no mortality.Under the conditions of the study, a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was associated with signs of toxicity but no mortality.The median lethal dose of after a single oral administration to female rats, observed over a period of 14 days is:LD50 cut-off (rat): 5000 mg/ kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07b99f7e-4d9f-4ace-b858-631c9f6d8555/documents/63abf77e-c198-4b52-9ea2-dd1c80fb5a58_9f616629-455c-4f28-b455-32c21cb9a5cd.html,,,,,, "Phosphonic acid, (4-morpholinylmethylene)bis-, tetraethyl ester",59646-46-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07b99f7e-4d9f-4ace-b858-631c9f6d8555/documents/63abf77e-c198-4b52-9ea2-dd1c80fb5a58_9f616629-455c-4f28-b455-32c21cb9a5cd.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Phosphonic acid, (4-morpholinylmethylene)bis-, tetraethyl ester",59646-46-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07b99f7e-4d9f-4ace-b858-631c9f6d8555/documents/63abf77e-c198-4b52-9ea2-dd1c80fb5a58_9f616629-455c-4f28-b455-32c21cb9a5cd.html,,inhalation,,"5,000 ",, "1,3-bis(3-(1H-imidazol-1-yl)propyl)urea",1807618-04-7," According to REACH Annex VII, column 2, the acute toxicity study does not generally need to be conducted if the substance is classified as corrosive to the skin, according to Regulation (EC) No 1272/2008.  ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/177cd1a9-c447-499d-852e-2f7c9d962fbc/documents/5aaa287b-2376-4213-ab91-edde8eb7a33c_dd3ad7a3-7b30-4faf-8bc4-53ed2837b470.html,,,,,, bis(cyclohexylmethyl) ether,14315-63-0," OECD 407: It was concluded that 12000 ppm represented the no-observed adverse effect level (NOAEL) when administered orally for 28 consecutive days to the rat. The substance was tested at dietary concentrations of 1500, 4500 and 12000 ppm equivalent to a mean achieved dosage of 121.9, 358.1 and 942.7 mg/kg bw/day for males and 120.9, 363.6 and 970.1 mg/kg bw/day for females respectively. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c02490ae-e538-41fc-ab1a-f3f353261047/documents/3bc7f90f-31e0-48a6-8cad-8f3fa5434cbe_bc03a2bc-3b6a-474d-b698-33e19c1bcc3d.html,,,,,, bis(cyclohexylmethyl) ether,14315-63-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c02490ae-e538-41fc-ab1a-f3f353261047/documents/3bc7f90f-31e0-48a6-8cad-8f3fa5434cbe_bc03a2bc-3b6a-474d-b698-33e19c1bcc3d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,942.7 mg/kg bw/day,,rat bis(cyclohexylmethyl) ether,14315-63-0, Acute oral toxicity: OECD TG 420: LD50 > 2000 mg/kg bw. Acute inhalation toxicity: OECD TG 403: LC50 > 5.11 mg/L Acute dermal toxicity: OECD TG 402: LD 50 > 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c02490ae-e538-41fc-ab1a-f3f353261047/documents/222281f3-594f-46fb-b715-89b69eedb1c7_bc03a2bc-3b6a-474d-b698-33e19c1bcc3d.html,,,,,, bis(cyclohexylmethyl) ether,14315-63-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c02490ae-e538-41fc-ab1a-f3f353261047/documents/222281f3-594f-46fb-b715-89b69eedb1c7_bc03a2bc-3b6a-474d-b698-33e19c1bcc3d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, bis(cyclohexylmethyl) ether,14315-63-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c02490ae-e538-41fc-ab1a-f3f353261047/documents/222281f3-594f-46fb-b715-89b69eedb1c7_bc03a2bc-3b6a-474d-b698-33e19c1bcc3d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, bis(cyclohexylmethyl) ether,14315-63-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c02490ae-e538-41fc-ab1a-f3f353261047/documents/222281f3-594f-46fb-b715-89b69eedb1c7_bc03a2bc-3b6a-474d-b698-33e19c1bcc3d.html,,inhalation,LC50,"5,110 mg/m3",no adverse effect observed, "N1,N3‐bis(3‐methylphenyl)‐5‐[(3‐methylphenyl)sulfamoyl]benzene‐1,3‐dicarboxamide",2375645-78-4,"Acute oral (OECDTG423): LD50 >2000 mg/kg bw Acute inhalation (OECDTG403): LC50 >5 mg/L. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study has klimisch code 1. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The study has klimisch code 1. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/527312bc-5a73-47f7-ac5e-58b0b0637be1/documents/daf311df-2bc1-4deb-a89a-765ea5f563fc_c20c74db-1e8a-4201-a0b6-c962fdacfee7.html,,,,,, "N1,N3‐bis(3‐methylphenyl)‐5‐[(3‐methylphenyl)sulfamoyl]benzene‐1,3‐dicarboxamide",2375645-78-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/527312bc-5a73-47f7-ac5e-58b0b0637be1/documents/daf311df-2bc1-4deb-a89a-765ea5f563fc_c20c74db-1e8a-4201-a0b6-c962fdacfee7.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "N1,N3‐bis(3‐methylphenyl)‐5‐[(3‐methylphenyl)sulfamoyl]benzene‐1,3‐dicarboxamide",2375645-78-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/527312bc-5a73-47f7-ac5e-58b0b0637be1/documents/daf311df-2bc1-4deb-a89a-765ea5f563fc_c20c74db-1e8a-4201-a0b6-c962fdacfee7.html,,inhalation,LC50,> 5 mg/L,no adverse effect observed, Beta-mannosidaseIUBMB 3.2.1.25,9025-43-8,"Beta-mannosidase was not tested for acute toxicity, but two closely-related enzymes, xylanase and alpha amylase, have been tested for acute toxicity. The acute toxicity of xylanase and alpha amylase was tested by administration by gavage as a single oral dose to a group of rats followed by an observation period of 14 days. No signs of toxicity were observed among the rats treated with a single oral dose of xylanase corresponding to 2536 mg enzyme concentrate dry matter/kg bodyweight (equivalent to 652 mg aep/kg bodyweight) or a single dose of alpha amylase corresponding 2562 mg enzyme concentrate dry matter/kg bodyweight (equivalent to 859 mg aep/kg bodyweight). Based on the similarity of the tested enzymes with beta-mannosidase - all belonging to the same enzyme sub-subclass - it can be concluded that similar results are expected for beta-mannosidase. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Toxicological data has been generated within the enzyme producing industry during the last 40 years. Substantial documentation on the safety of the production strains have been generated, and the enzyme test materials are thoroughly characterized. High quality studies for all relevant endpoints, in vivo studies as well as in vitro studies, show that industrial enzymes from well-known and well-characterized production strains have very similar safety profiles across the catalytic activities. Read-across can therefore be applied for the majority of toxicological endpoints. The database can thus be considered of high quality. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b018b02-c752-4e93-9b0f-dc065074b5db/documents/0cf42964-496f-46a5-93fc-31912d24e48b_fa2c6e94-935a-4fe3-8ba8-f531080e2815.html,,,,,, "Reaction mass of (2R,4aR,8aS)-5,5-dimethyl-2-propylhexahydro-2H-2,4a-methanonaphthalen-1(5H)-one and (2S,4aS,8aR)-5,5-dimethyl-2-propylhexahydro-2H-2,4a-methanonaphthalen-1(5H)-one",1441045-54-0," Oral LD50 > 5000 mg/kg bw (OECD 423, K, Rel.1) Dermal LD50 > 2000 mg/kg bw (OECD 402, K, Rel.1) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a034710e-db87-4d78-b11f-d3ecf3f100a7/documents/8bce7e4c-0da0-47da-85f3-e90d1c8365fe_49d27bfd-a57d-4746-b4b8-b06e889972a9.html,,,,,, "Reaction mass of (2R,4aR,8aS)-5,5-dimethyl-2-propylhexahydro-2H-2,4a-methanonaphthalen-1(5H)-one and (2S,4aS,8aR)-5,5-dimethyl-2-propylhexahydro-2H-2,4a-methanonaphthalen-1(5H)-one",1441045-54-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a034710e-db87-4d78-b11f-d3ecf3f100a7/documents/8bce7e4c-0da0-47da-85f3-e90d1c8365fe_49d27bfd-a57d-4746-b4b8-b06e889972a9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Reaction mass of (2R,4aR,8aS)-5,5-dimethyl-2-propylhexahydro-2H-2,4a-methanonaphthalen-1(5H)-one and (2S,4aS,8aR)-5,5-dimethyl-2-propylhexahydro-2H-2,4a-methanonaphthalen-1(5H)-one",1441045-54-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a034710e-db87-4d78-b11f-d3ecf3f100a7/documents/8bce7e4c-0da0-47da-85f3-e90d1c8365fe_49d27bfd-a57d-4746-b4b8-b06e889972a9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "(3E)-4-[(1S,3aS,4R,7aS)-1,7a-dimethyloctahydro-4H-1,4-methanoinden-4-yl]pent-3-en-2-one",143785-33-5, Oral LD50 is >2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e97e4575-baa0-4637-a9f4-c2c6c1dc79aa/documents/e664fe47-396b-409f-878d-2eeac79a0b7d_d530210a-6362-4e63-bad2-96bea85a08a9.html,,,,,, "(3E)-4-[(1S,3aS,4R,7aS)-1,7a-dimethyloctahydro-4H-1,4-methanoinden-4-yl]pent-3-en-2-one",143785-33-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e97e4575-baa0-4637-a9f4-c2c6c1dc79aa/documents/e664fe47-396b-409f-878d-2eeac79a0b7d_d530210a-6362-4e63-bad2-96bea85a08a9.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, (2S)-2-amino-3-(4-phosphonooxyphenyl)propanoic acid,21820-51-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33058116-cc8d-442c-b30b-fe425cffef32/documents/b7af25b1-2f30-48e9-a28c-942023875eb9_4ce287dd-89da-4831-bd32-bf81c64ba6b3.html,,oral,LD50,> 618 mg/kg bw,no adverse effect observed, {2-[(2-methylundec-1-en-1-yl)oxy]ethyl}benzene,2489743-82-8," Oral (gavage): NOAEL (rat, systemic toxicity): ≥ 1000 mg/kg bw/day, male/female, OECD TG 422, 2021 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edd36688-8669-4556-bfa4-d31a0a2d2103/documents/bcc595d9-fcf3-418f-8ff8-d955354703c4_684a1769-ba5c-48bc-b6c2-0a23378bf1fb.html,,,,,, {2-[(2-methylundec-1-en-1-yl)oxy]ethyl}benzene,2489743-82-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edd36688-8669-4556-bfa4-d31a0a2d2103/documents/bcc595d9-fcf3-418f-8ff8-d955354703c4_684a1769-ba5c-48bc-b6c2-0a23378bf1fb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat {2-[(2-methylundec-1-en-1-yl)oxy]ethyl}benzene,2489743-82-8," Oral: LD50 > 2000 mg/kg bw and the LD50= LD50 cut-off was considered to be > 5000mg/kg bw female rat, OECD TG 423, 2019 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edd36688-8669-4556-bfa4-d31a0a2d2103/documents/816dbbfe-edcb-4786-be29-77e29e62cbef_684a1769-ba5c-48bc-b6c2-0a23378bf1fb.html,,,,,, {2-[(2-methylundec-1-en-1-yl)oxy]ethyl}benzene,2489743-82-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edd36688-8669-4556-bfa4-d31a0a2d2103/documents/816dbbfe-edcb-4786-be29-77e29e62cbef_684a1769-ba5c-48bc-b6c2-0a23378bf1fb.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Coffee, bean, roasted, ext.",68916-18-7," NOAEL (rat, 91 days): 25% brewed and instant coffee dilutions, equivalent to 20 mg/kg bw/day of caffeine. NOAEL (rat, 90 days): 1'500 ppm; males 151 mg/kg bw/day; females 174 mg/kg bw/day of caffeine NOAEL (mouse, 90 days): 1'500 ppm; males 167 mg/kg bw/day; females 179 mg/kg bw/day of caffeine NOAEL (rat, 2 years): 2'000 ppm, males 102 mg/kg bw/day; females 170 mg/kg bw/day of caffeine ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c017cbd9-d9d9-4ab9-98bb-13ec7ab1dadd/documents/4a609936-a275-4372-a0da-8e9cb0deb447_00edbddd-b8ec-4d95-bcc7-a815581b5f72.html,,,,,, "Coffee, bean, roasted, ext.",68916-18-7, ORAL LD50: >2000 mg/kg bw (Coffea Canephora robusta) LD50: 220 - 412 mg/kg bw (Caffeine) INHALATION LC50: 4.94 mg/l (Caffeine) DERMAL LD50: >2000 mg/kg bw (Caffeine) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c017cbd9-d9d9-4ab9-98bb-13ec7ab1dadd/documents/4b2885e3-3122-4e3a-ba76-a2d3160490e0_00edbddd-b8ec-4d95-bcc7-a815581b5f72.html,,,,,, "(4E)-2,4-dimethyl-5-(4-methylphenyl)pent-4-enal",1226911-73-4,"LD50 (oral, rat) > 2000 mg/kg bw (OECD 420, GLP) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information as a whole meets the tonnage driven information requirements of REACH. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The available information as a whole meets the tonnage driven information requirements of REACH. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The available information as a whole meets the tonnage driven information requirements of REACH. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6bcada29-0477-431c-941a-db3a6ce11f8a/documents/91d899a3-a9cc-4e76-b429-8bd220fc8f23_542babe4-b0d6-4e8d-8059-7103e06d6a81.html,,,,,, "(4E)-2,4-dimethyl-5-(4-methylphenyl)pent-4-enal",1226911-73-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6bcada29-0477-431c-941a-db3a6ce11f8a/documents/91d899a3-a9cc-4e76-b429-8bd220fc8f23_542babe4-b0d6-4e8d-8059-7103e06d6a81.html,,oral,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, "(5R)-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)furan-2-one",2875066-35-4,"The acute oral LD50 of the substance was predicted to be ca. 1003.06 mg/kg bw. Based on the CLP (Reg. (EC) 1272/2008) criteria, the substance VRT-1097043 is classified as acute toxic Cat. 4.  ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e84fde8d-155a-4266-ab04-6ad8172d766c/documents/825b1540-f288-452b-a52f-bea7d5ac8450_5aea170a-f62f-43a4-aa96-a08e5683e784.html,,,,,, "(5R)-3-(3,4-difluoro-2-methoxyphenyl)-4,5-dimethyl-5-(trifluoromethyl)furan-2-one",2875066-35-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e84fde8d-155a-4266-ab04-6ad8172d766c/documents/825b1540-f288-452b-a52f-bea7d5ac8450_5aea170a-f62f-43a4-aa96-a08e5683e784.html,,oral,LD50,"ca.1,003.06 mg/kg bw",adverse effect observed, "(1R,3S)-3-aminocyclopentan-1-ol benzoate",1846582-38-4,"Repeated dose toxicity: oralA 4-week Repeated Dose Toxicity Study of GS-642207-03 via Oral Gavage in Sprague Dawley Rats with a 2-week Recovery PeriodEndpoint summaryGS-642207-03 was administered to Sprague-Dawley via oral gavage once daily at 0 (0.5% MC), 500, 1000, and 2000 mg/kg for 4 consecutive weeks followed by a 2-week recovery period. All animals survived to scheduled necropsy. Toxicological changes related to the test article included tubule degeneration in the kidney at ≥500 mg/kg, salivation at ≥1000 mg/kg, decreased body-weight gains and food consumption (only in females), increased AST (only in males), BUN, CREA, P (only for male), decreased K, Cl (only for male), neuronal necrosis in the hippocampus in the brain, and hepatocellular hypertrophy in the liver at 2000 mg/kg. All the above-mentioned changes were completely recovered (except decreased body weights gains and food consumption (only in females), and neuronal necrosis in the hippocampus in the brain at 2000 mg/kg) at the end of the recovery period. Therefore, the NOAEL was considered to be 1000 mg/kg. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4aa9237a-f95c-4822-9099-9b12ed264053/documents/99745b29-23a2-40fa-8b14-5b177101b0b2_3756bd12-ad3d-4952-8b2a-1269be332b42.html,,,,,, "(1R,3S)-3-aminocyclopentan-1-ol benzoate",1846582-38-4,Acute Toxicity: oralAcute Oral Toxicity Study in the Rat – Fixed Dose MethodEndpoint summaryThe acute median lethal oral dose (LD50) to rats of GS-642207-03 was demonstrated to be greater than 2000 mg/kg body weight. GS-642207-03 is unclassified in accordance with European Commission regulation 1272/2008. Acute Toxicity: dermalAcute Dermal Toxicity Study in the Rat – Fixed Dose MethodEndpoint summaryThe acute dermal median lethal dose (LD50) to rats of GS-642207-03 was found to be greater than 2000 mg/kg body weight. GS-642207-03 is unclassified in accordance with European Commission regulation 1272/2008. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aa9237a-f95c-4822-9099-9b12ed264053/documents/2220d492-9c26-44a6-bcf2-35ccd65c3b8a_3756bd12-ad3d-4952-8b2a-1269be332b42.html,,,,,, trans-(4-(methylamino)cyclohexyl)methanesulfonic acid,2124221-12-9,"An oral study is available. The study is performed according to OECD Guideline 425. Initially, a single female Sprague Dawley rat was dosed orally with test item at dose level of 2000 mg/kg. Since the animal survived, four additional females were dosed at 2000 mg/kg. The oral LD50 of test item is greater than 2000 mg/kg of body weight in female rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable without restriction ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c655bfaa-d956-46d9-a919-6409afe8ea40/documents/e342c42d-80d8-4136-86e6-ac615b3be94e_83ac1392-d9ed-493c-83dd-8c80de595a3f.html,,,,,, trans-(4-(methylamino)cyclohexyl)methanesulfonic acid,2124221-12-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c655bfaa-d956-46d9-a919-6409afe8ea40/documents/e342c42d-80d8-4136-86e6-ac615b3be94e_83ac1392-d9ed-493c-83dd-8c80de595a3f.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "3,7-dimethylnon-6-en-1-ol",41972-59-2,"Based on read-across, the LD50 oral of 2390 mg/kg bw in the read-across study has been selected as the key value for hazard classification and chemical safety assessment of the test substance.According to the LD50 values described above, both analogues and the target substance are associated with the same GHS/CLP classification (not classified). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/794400fa-1582-47a9-9c71-791b489ed1de/documents/46ccc01e-eeae-4956-9187-9039f6b981b7_22666b95-406a-4eb8-b838-6412b6604a1d.html,,,,,, "3,7-dimethylnon-6-en-1-ol",41972-59-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/794400fa-1582-47a9-9c71-791b489ed1de/documents/46ccc01e-eeae-4956-9187-9039f6b981b7_22666b95-406a-4eb8-b838-6412b6604a1d.html,,oral,LD50,"2,390 mg/kg bw",no adverse effect observed, "2,2',2''-[(Methylsilanetriyl)tris(oxy)] tripropanamine",2399457-62-4,"Repeated dose toxicity: Oral A 2-week range-finding rat oral study found some evidence of toxicity at 600 mg/kg bw/day but no clear effects at 200 mg/kg bw/day. Dose levels of 70, 200 and 600 mg/kg bw/day were selected for the 90-day oral toxicity study.   Repeated dose toxicity: inhalation a short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment   Repeated dose toxicity: dermal The acute dermal toxicity value for the test substance (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Waiver Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Waiver Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Data is from secondary source ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee742a3b-dd5d-4a0f-b75c-cf45aedb4996/documents/3125aae2-41b7-4731-aa02-6bf8aca3f69d_e89cdcf7-085a-4aab-8976-184566a4f307.html,,,,,, "2,2',2''-[(Methylsilanetriyl)tris(oxy)] tripropanamine",2399457-62-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee742a3b-dd5d-4a0f-b75c-cf45aedb4996/documents/3125aae2-41b7-4731-aa02-6bf8aca3f69d_e89cdcf7-085a-4aab-8976-184566a4f307.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "2,2',2''-[(Methylsilanetriyl)tris(oxy)] tripropanamine",2399457-62-4,"Acute Oral studies:The Acute Oral toxicity of the chemical  LD50 value of the test chemical in Rats (Sprague-Dawley) was found to be 2400 mg/kg b w( 2413 mg/kg bw) as per EEC directive 91/325. Acute Inhalation:In a study, conducted in accordance with generally accepted scientific standards and probably according to GLP, male and female rats exposed to a 60% aqueous solution of the test substance achieved an LC50 of over 7.35 mg/l after four hours. Acute Dermal:The LD 50 value of chemical test 3-aminopropyltriethoxysilane in rabbits at a dose of 8.0mg /kg bw was found to be 4290 mg/kg bw(equivalent to 3800 mg/kg bw). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The data supports to K4 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The data supports to K4 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The data supports to K4 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee742a3b-dd5d-4a0f-b75c-cf45aedb4996/documents/f2cc3cb4-0228-487d-936b-da65a69d07c8_e89cdcf7-085a-4aab-8976-184566a4f307.html,,,,,, "2,2',2''-[(Methylsilanetriyl)tris(oxy)] tripropanamine",2399457-62-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee742a3b-dd5d-4a0f-b75c-cf45aedb4996/documents/f2cc3cb4-0228-487d-936b-da65a69d07c8_e89cdcf7-085a-4aab-8976-184566a4f307.html,,oral,LD50,"2,413 mg/kg bw",no adverse effect observed, "2,2',2''-[(Methylsilanetriyl)tris(oxy)] tripropanamine",2399457-62-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee742a3b-dd5d-4a0f-b75c-cf45aedb4996/documents/f2cc3cb4-0228-487d-936b-da65a69d07c8_e89cdcf7-085a-4aab-8976-184566a4f307.html,,dermal,LD50,"4,290 mg/kg bw",no adverse effect observed, "2,2',2''-[(Methylsilanetriyl)tris(oxy)] tripropanamine",2399457-62-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee742a3b-dd5d-4a0f-b75c-cf45aedb4996/documents/f2cc3cb4-0228-487d-936b-da65a69d07c8_e89cdcf7-085a-4aab-8976-184566a4f307.html,,inhalation,LC50,7.35 mg/L,no adverse effect observed, "Hexanedioic acid, 1,6-bis[2-hydroxy-3-[(1-oxoneodecyl)oxy]propyl] ester",876528-25-5," Based on the results of a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test in rats following OECD 422 the parental NOAELs were determined with 150 mg/kg bw/day for males (based on increased incidence and severity in hyaline droplet accumulation, tubular basophilia and granular casts in male kidneys at 500 mg/kg bw/day) and 500 mg/kg bw/day for females. Since the renal findings are regarded as a male rat specific response, a NOAEL of 500 mg/kg bw/day is indicated for humane risk assessment purposes. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1174bdba-8137-4e50-9ead-231537d5eb77/documents/cf2b67de-9c6d-48df-8bbf-b181a224df19_fbe360dc-4b9b-4483-a139-5157804ff627.html,,,,,, "Hexanedioic acid, 1,6-bis[2-hydroxy-3-[(1-oxoneodecyl)oxy]propyl] ester",876528-25-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1174bdba-8137-4e50-9ead-231537d5eb77/documents/cf2b67de-9c6d-48df-8bbf-b181a224df19_fbe360dc-4b9b-4483-a139-5157804ff627.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Hexanedioic acid, 1,6-bis[2-hydroxy-3-[(1-oxoneodecyl)oxy]propyl] ester",876528-25-5, acute oral toxicity rat (OECD TG 423): LD50 > 2000 mg/kg bw acute dermal toxicity rat (OECD TG 402): LD50 > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1174bdba-8137-4e50-9ead-231537d5eb77/documents/e9875ec9-6c5d-46d7-9a78-52338c387514_fbe360dc-4b9b-4483-a139-5157804ff627.html,,,,,, "Hexanedioic acid, 1,6-bis[2-hydroxy-3-[(1-oxoneodecyl)oxy]propyl] ester",876528-25-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1174bdba-8137-4e50-9ead-231537d5eb77/documents/e9875ec9-6c5d-46d7-9a78-52338c387514_fbe360dc-4b9b-4483-a139-5157804ff627.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Hexanedioic acid, 1,6-bis[2-hydroxy-3-[(1-oxoneodecyl)oxy]propyl] ester",876528-25-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1174bdba-8137-4e50-9ead-231537d5eb77/documents/e9875ec9-6c5d-46d7-9a78-52338c387514_fbe360dc-4b9b-4483-a139-5157804ff627.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, [phthalato(2-)]dioxotrilead,69011-06-9," Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/943c25a2-bf88-4372-8e84-205232d752b1/documents/2f1b4eb3-8bbe-445a-a0d0-46b049196a4f_5fe18955-61a2-40ab-a265-f601584f6052.html,,,,,, [phthalato(2-)]dioxotrilead,69011-06-9, Inorganic lead compounds do not exhibit toxicity in acute toxicity tests with experimental animals. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/943c25a2-bf88-4372-8e84-205232d752b1/documents/IUC5-797a2504-731a-4faa-ac05-08faf990a290_5fe18955-61a2-40ab-a265-f601584f6052.html,,,,,, [phthalato(2-)]dioxotrilead,69011-06-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/943c25a2-bf88-4372-8e84-205232d752b1/documents/IUC5-797a2504-731a-4faa-ac05-08faf990a290_5fe18955-61a2-40ab-a265-f601584f6052.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, [phthalato(2-)]dioxotrilead,69011-06-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/943c25a2-bf88-4372-8e84-205232d752b1/documents/IUC5-797a2504-731a-4faa-ac05-08faf990a290_5fe18955-61a2-40ab-a265-f601584f6052.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, [phthalato(2-)]dioxotrilead,69011-06-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/943c25a2-bf88-4372-8e84-205232d752b1/documents/IUC5-797a2504-731a-4faa-ac05-08faf990a290_5fe18955-61a2-40ab-a265-f601584f6052.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "[R-(R*,R*)]-α-[1-(methylamino)ethyl]benzyl alcohol",321-97-1,"In an acute oral toxicity study (OECD 401) with pseudoephedrine hydrochloride, a structural analogue of [R-(R*,R*)]-α-[1-(methylamino)ethyl]benzyl alcohol, the LD50 was determined to be ca. 1000 and 464 mg/kg bw for male and female rats, respectively. After correction for molecular weight the LD50 is determined to be 804 and 373 mg/kg bw for male and female rats, respectively.. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bcb8729-18da-45b8-9179-92b2730e42e7/documents/IUC5-f98d5a9c-4a65-4003-a396-e5b46f6d72ce_6a73127a-39e5-4403-9484-b46b7627a981.html,,,,,, "[R-(R*,R*)]-α-[1-(methylamino)ethyl]benzyl alcohol",321-97-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bcb8729-18da-45b8-9179-92b2730e42e7/documents/IUC5-f98d5a9c-4a65-4003-a396-e5b46f6d72ce_6a73127a-39e5-4403-9484-b46b7627a981.html,,oral,LD50,373 mg/kg bw,adverse effect observed, "[trans(trans)]- 4-Methyl-4'-propyl-1,1'-bicyclohexyl",92343-70-9, OECD 423: LD50 > 2000 mg/kg bw ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8aa13cb3-5c92-4166-a58e-d9425c1d3d67/documents/b95e657b-a38e-474a-8819-30c589e57e7f_2da97d77-0f6d-4eb9-9e2a-ec9868f13ebf.html,,,,,, "[trans(trans)]- 4-Methyl-4'-propyl-1,1'-bicyclohexyl",92343-70-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8aa13cb3-5c92-4166-a58e-d9425c1d3d67/documents/b95e657b-a38e-474a-8819-30c589e57e7f_2da97d77-0f6d-4eb9-9e2a-ec9868f13ebf.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "[x·sodium, y·lithium, x+y=3] 4-amino-3[[4-[[4-[(2-amino-4-hydroxyphenyl)diazenyl]phenyl]amino]-3-sulfonato phenyl]diazenyl]-5-hydroxy-6-(phenydiazenyl)naphthalene-2,7-disulfonat, mixture of isomers",2218502-12-4,"To assess the repeated dose toxicity of the substance with CAS 2218502-12-4 (Direct Black 168 NaLi salts), an in vivo study conducted on the similar substance (read-across) with CAS 93281-13-1(Direct Black 168 NaLi) has been chosen. The observations of the study, conducted according to OECD 422 GLP compliant, support that the substance is not classified for toxicity following repeated dose oral route. Based on the study outcomes, the dose level of 350 mg/kg bw/day was considered as an appropriate No Observed Adverse Effect Level to be used for the Chemical Safety Assessment and DNEL derivation of the source substance. Both substances CAS 218502-12-4 (Direct Black 168 NaLi salt) and CAS 93281-13-1 (Direct Black 168 Na salt) have the same organic anionic structure. The differences are considered to be not able to impact the study outcome, thus the read-across can be considered as reliable and appropriate to evaluate the endpoint. Details on read-across approach are given in the section 13 of IUCLID file. Based on exposure considerations and the available toxicological information, testing in a 28-days by oral route, has been considered sufficient and the dermal study on repeated dose does not need to be conducted. The repeated dose inhalation study does not need to be conducted because the exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb9eaba6-9526-460d-9efe-644fb7b0c0e1/documents/25ef059f-5557-42d3-92b1-403af20e1dc0_7223cdf9-14c4-4566-9f88-d7b49871a1a1.html,,,,,, "[x·sodium, y·lithium, x+y=3] 4-amino-3[[4-[[4-[(2-amino-4-hydroxyphenyl)diazenyl]phenyl]amino]-3-sulfonato phenyl]diazenyl]-5-hydroxy-6-(phenydiazenyl)naphthalene-2,7-disulfonat, mixture of isomers",2218502-12-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb9eaba6-9526-460d-9efe-644fb7b0c0e1/documents/25ef059f-5557-42d3-92b1-403af20e1dc0_7223cdf9-14c4-4566-9f88-d7b49871a1a1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,350 mg/kg bw/day,,rat "[x·sodium, y·lithium, x+y=3] 4-amino-3[[4-[[4-[(2-amino-4-hydroxyphenyl)diazenyl]phenyl]amino]-3-sulfonato phenyl]diazenyl]-5-hydroxy-6-(phenydiazenyl)naphthalene-2,7-disulfonat, mixture of isomers",2218502-12-4,"The acute toxicity of the substance CAS 2218502-12-4 (Direct Black 168 NaLi salts) has been determined by read-across from a structural analogue substance CAS 93281-13 -1 (Direct Black 168 Na salt). There are available adequate studies conducted with the source substance following oral administration in rats (OECD 401, GLP compliant) and dermal administration in rats (OECD 402, GLP compliant). No studies are available for the determination of acute toxicity by inhalation.     ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb9eaba6-9526-460d-9efe-644fb7b0c0e1/documents/3f466e31-38ac-41e0-a5d7-5031806d1f33_7223cdf9-14c4-4566-9f88-d7b49871a1a1.html,,,,,, "[x·sodium, y·lithium, x+y=3] 4-amino-3[[4-[[4-[(2-amino-4-hydroxyphenyl)diazenyl]phenyl]amino]-3-sulfonato phenyl]diazenyl]-5-hydroxy-6-(phenydiazenyl)naphthalene-2,7-disulfonat, mixture of isomers",2218502-12-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb9eaba6-9526-460d-9efe-644fb7b0c0e1/documents/3f466e31-38ac-41e0-a5d7-5031806d1f33_7223cdf9-14c4-4566-9f88-d7b49871a1a1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "[x·sodium, y·lithium, x+y=3] 4-amino-3[[4-[[4-[(2-amino-4-hydroxyphenyl)diazenyl]phenyl]amino]-3-sulfonato phenyl]diazenyl]-5-hydroxy-6-(phenydiazenyl)naphthalene-2,7-disulfonat, mixture of isomers",2218502-12-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb9eaba6-9526-460d-9efe-644fb7b0c0e1/documents/3f466e31-38ac-41e0-a5d7-5031806d1f33_7223cdf9-14c4-4566-9f88-d7b49871a1a1.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "[μ-(5-amino-1,3,3-trimethylcyclohexylamine-N:N')]hexafluorodiboron",87788-32-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/87316a8f-074e-492b-ba87-2758a89340b3/documents/a3d7a347-d5d1-4393-92ce-f2605fc9888d_15762e96-f0d2-4790-a5ce-15c9cf482749.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat "[μ-(5-amino-1,3,3-trimethylcyclohexylamine-N:N')]hexafluorodiboron",87788-32-7, The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 to 2000 mg/kg body weight (Globally Harmonized Classification System Category 4). While the acute dermal LD50 is greater than 2000 mg/kg. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87316a8f-074e-492b-ba87-2758a89340b3/documents/ab592dee-ccff-4129-a0d5-a47944f12a02_15762e96-f0d2-4790-a5ce-15c9cf482749.html,,,,,, "[μ-(5-amino-1,3,3-trimethylcyclohexylamine-N:N')]hexafluorodiboron",87788-32-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87316a8f-074e-492b-ba87-2758a89340b3/documents/ab592dee-ccff-4129-a0d5-a47944f12a02_15762e96-f0d2-4790-a5ce-15c9cf482749.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, "[μ-(5-amino-1,3,3-trimethylcyclohexylamine-N:N')]hexafluorodiboron",87788-32-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87316a8f-074e-492b-ba87-2758a89340b3/documents/ab592dee-ccff-4129-a0d5-a47944f12a02_15762e96-f0d2-4790-a5ce-15c9cf482749.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "[μ-[[3,3'-[azoxybis[(2-hydroxy-p-phenylene)azo]]bis[4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicopper, tetrasodium salt",75173-68-1," Acute oral toxicity:  Acute oral toxicity dose (LD50) of [μ-[[3,3'-[azoxybis[(2-hydroxy-p-phenylene)azo]]bis[4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicopper, tetrasodium salt (CAS no: 75173-68-1) was predicted based on OECD QSAR toolbox, the value estimated to be 6892 mg/kg bw and different studies available on structurally similar read across substances Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo)) naphthalene-4,6-disulphonate (CAS No. 2519-30-4), the LD50 was considered to be >2000 mg/kg bw and Disodium 4-hydroxy-3-[(4-sulfonato-1-naphthyl)diazenyl]naphthalene-1-sulfonate (CAS no: 3567-69-9), the LD50 was considered to be 4166.66 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, [μ-[[3,3'-[azoxybis[(2-hydroxy-p-phenylene)azo]]bis[4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicopper, tetrasodium salt cannot be classified for acute oral toxicity. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for [μ-[[3,3'-[azoxybis[(2-hydroxy-p-phenylene)azo]]bis[4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicopper, tetrasodium salt (CAS no: 75173-68-1) was predicted based on OECD QSAR toolbox, the value estimated to be 9606 mg/kg bw and different studies available for the structurally similar read across substances Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate (CAS No. 2519-30-4) LD50 was considered to be >2000 mg/kg bw and Disodium 4-hydroxy-3-[(4-sulfonato-1-naphthyl)diazenyl]naphthalene-1-sulfonate (CAS no: 3567-69-9)LD50 was considered to be >2000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, [μ-[[3,3'-[azoxybis[(2-hydroxy-p-phenylene)azo]]bis[4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicopper, tetrasodium salt cannot be classified for acute dermal toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71413245-ed44-4bc2-92cd-14b6a967be09/documents/ce4d0e7b-a0ef-405f-8ce5-3477d716d288_cabfbbaa-a254-4d09-b641-cf200ed713f9.html,,,,,, "[μ-[[3,3'-[azoxybis[(2-hydroxy-p-phenylene)azo]]bis[4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicopper, tetrasodium salt",75173-68-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71413245-ed44-4bc2-92cd-14b6a967be09/documents/ce4d0e7b-a0ef-405f-8ce5-3477d716d288_cabfbbaa-a254-4d09-b641-cf200ed713f9.html,,oral,LD50,"6,892 mg/kg bw",no adverse effect observed, "[μ-[[3,3'-[azoxybis[(2-hydroxy-p-phenylene)azo]]bis[4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicopper, tetrasodium salt",75173-68-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71413245-ed44-4bc2-92cd-14b6a967be09/documents/ce4d0e7b-a0ef-405f-8ce5-3477d716d288_cabfbbaa-a254-4d09-b641-cf200ed713f9.html,,dermal,LD50,"9,606 mg/kg bw",no adverse effect observed, [μ-[carbonato(2-)-O:O']]dihydroxydioxodizirconium,57219-64-4,"Repeated dose toxicity: oralTwo studies are used in a 'weight-of-evidence' approach.In the first study, Rossiello (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test via oral route in rats with the read-across substance zirconium acetate according to OECD guideline 422 (GLP). A NOAEL of >= 1000 mg/kg bw/day was derived. No adverse effects were reported in this study. This study was scored as K2 study (reliable with restrictions) because of read-across purposes. The read-across justification is included in the Section 13 of IUCLID.In the second study, no effects were reported after oral administration to rats during 17 weeks of zirconium basic carbonate (hydrated form) in the form of a moist paste containing 20.9% zirconium dioxide equivalent. The NOAEL for the tested material was greater than 15100 mg hydrated zirconium carbonate/kg bw/day (Harrison et al., 1951).Repeated dose toxicity: dermalNo data were available for repeated dose toxicity, inhalation route of exposure.Repeated dose toxicity: dermalNo reliable data were available for repeated dose toxicity, dermal route of exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67d05ad7-26ae-4d47-9f2d-dc07238e910d/documents/IUC5-61956944-8d26-4698-a241-60b88b1920c9_c96987bd-ac5b-4275-8ffe-ef2b0a63538e.html,,,,,, [μ-[carbonato(2-)-O:O']]dihydroxydioxodizirconium,57219-64-4,"Acute toxicity: oralOne study was performed according to a method similar to OECD Guideline No. 401 on albino rats with hydrated zirconium basic carbonate (Harrison, 1951). In this study the LD50 is determined to be > 47 850 mg/kg bw (based on test material).Acute toxicity: inhalationOne study was performed according to OECD Guideline No. 436 on Crl:CD (SD) rats with zirconium basic carbonate (Smith, 2013). In this study the LC50 was determined to be > 4.74 mg/L air (analytical, based on test material). Acute toxicity: dermalNo study available for this endpoint. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67d05ad7-26ae-4d47-9f2d-dc07238e910d/documents/IUC5-6ef7a330-ad13-46f3-b9f4-bd25c4ba70e6_c96987bd-ac5b-4275-8ffe-ef2b0a63538e.html,,,,,, "1-(1,1-dimethylpropylperoxy)-1-methoxycyclohexane",125768-93-6," The acute oral and dermal LD0 of 1,1-dimethylpropyl 1-methoxycyclohexyl peroxide are higher than 2000 mg/kg bw. Oral route The potential for oral toxicity of 1,1-dimethylpropyl 1-methoxycyclohexyl peroxide (Luperox XPS-TP) was evaluated using the Acute Toxic Class Determination following the OECD Guidelines no. 423 (Cerven, 2005a). Three healthy male and three healthy female Wistar albino rats were dosed orally with Luperox XPS-TP at 2000 mg/kg. The rats were observed 0.5, 1, 2, 3 and 4 hours postdose and once daily for 14 days for mortality, toxicity and pharmacological effects. Body weights were recorded immediately pretest, weekly and at termination. All animals were examined for gross pathology. Abnormal tissues were preserved in 10% neutral buffered formalin for possible future histological examination. All three male and three female animais survived the 2000 mg/kg oral dose. Instances of localized alopecia were the only abnormal physical signs noted during the observation period. Body weight changes were normal 5/6 animals. One female lost a slight amount of body weight between day 7 and day 14. Necropsy results revealed localized alopecia in two animals and darker than normal kidneys in 5/6 animals. One animal appeared normal during necropsy. The LD0 is > 2000 mg/kg. Dermal route The potential for toxicity of 1,1-dimethylpropyl 1-methoxycyclohexyl peroxide (Luperox XPS-TP) when applied dermally was evaluated following the OECD Guideline no. 402 (Gilotti, 2005b). Five healthy male and five healthy female Wistar Albino rats were dosed dermally with Luperox XPS-TP at 2000 mg/kg of body weight. The test article was kept in contact with the skin for 24 hours. Dermal responses were recorded at 24 hours postdose and on days 7 and 14. Animals were observed for toxicity and pharmacological effects at 1, 2 and 4 hours postdose and once daily for 14 days. All animals were observed twice a day for mortality. Body weights were recorded pretest, weekly and at termination. All animals were examined for gross pathology. Abnormal tissues were preserved in 10% neutral buffered formalin for possible future histological examination. All ten animals survived the 2000 mg/kg dermal application. Instances of chromorhinorrhea were noted during exposure and instances of alopecia on the front limbs were noted during the study. Dermal effects were absent during the study. Body weight changes were normal in 8/10 animals. One female lost weight during the first week, but gained normally during the second week. Another female lost weight during the second week. Necropsy results revealed abnormalities of the kidneys in 7/10 animals and alopecia was noted in 2 females. The dermal LD0 is higher than 2000 mg/kg of body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3948160d-96b9-4c16-b28a-616eb8b744b0/documents/IUC5-0a888376-6adb-49d1-b885-d07d574afe85_115c2828-b05c-47e7-9cfb-7e6e32986b24.html,,,,,, "1-(1,1-dimethylpropylperoxy)-1-methoxycyclohexane",125768-93-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3948160d-96b9-4c16-b28a-616eb8b744b0/documents/IUC5-0a888376-6adb-49d1-b885-d07d574afe85_115c2828-b05c-47e7-9cfb-7e6e32986b24.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1-(1,1-dimethylpropylperoxy)-1-methoxycyclohexane",125768-93-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3948160d-96b9-4c16-b28a-616eb8b744b0/documents/IUC5-0a888376-6adb-49d1-b885-d07d574afe85_115c2828-b05c-47e7-9cfb-7e6e32986b24.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1-(2,4,6-trichlorophenyl)propan-2-one",1228284-86-3,"Oral: LD50 >2000 mg/kg bw, rat, Zelenák 2014Dermal: LD50 >2000 mg/kg bw, rat, Matting 2015 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31abcf95-157d-4d02-a4fa-ecef4b9d2342/documents/IUC5-13259212-93a5-4a73-a762-b64afdd5f478_005fbaae-824b-4837-bd85-43a794a6ed9d.html,,,,,, "N-Methoxy-1-(2,4,6-trichlorophenyl)propan-2-imine",1228284-89-6,"Oral: LD50 >2000 mg/kg bw, rat, Matting 2015Dermal: LD50 >2000 mg/kg bw, rat, Matting 2015 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df7dcaaf-b847-4467-b59f-ae8b857bd005/documents/IUC5-fd816dee-494a-43ca-b6e8-38b14fa5576b_1bc081ad-5897-45f1-8bc9-5b3befc0f4ca.html,,,,,, "1-(2,4-dichlorophenyl)ethan-1-one",2234-16-4, Key study: OECD Guideline 423 and EU Method B.1.tris. GLP study. The acute oral LD50 value of the test item was found to be above 2000 mg/kg bw in female Crl:WI Wistar rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51265573-bcbb-4110-8979-22b47e79f8dd/documents/ddaab729-8cbf-45c9-9792-e085e3fad83b_884b7226-7da5-4ebb-b92f-8887d6bf1a8a.html,,,,,, "1-(2,4-dichlorophenyl)ethan-1-one",2234-16-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51265573-bcbb-4110-8979-22b47e79f8dd/documents/ddaab729-8cbf-45c9-9792-e085e3fad83b_884b7226-7da5-4ebb-b92f-8887d6bf1a8a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol",81541-12-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch reliability 2. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6491fd75-edc5-4a52-a9d0-b6ee01a07f86/documents/IUC5-e0a919bf-6751-4686-91e0-ef8f7a11d55d_7ac260b7-c249-4e2f-acd8-e8d7c4206af3.html,,,,,, "1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol",81541-12-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6491fd75-edc5-4a52-a9d0-b6ee01a07f86/documents/IUC5-e0a919bf-6751-4686-91e0-ef8f7a11d55d_7ac260b7-c249-4e2f-acd8-e8d7c4206af3.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-(2-butoxy-1-methylethoxy)propan-2-ol,29911-28-2,"For repeated dose toxicity of DPnB, studies via oral, dermal and inhalation exposure are availalbe.Oral: 14-d oral gavage and 90-d dietary studies in rats. These are GLP-studies conducted according to OECD guidelines 407&408.Dermal: 90-d dermal study in rats. This is a GLP-study conducted according to OECD guideline 411.Inhalation: one 14-d vapor inhalation study in rats and one 14-d aerosol inhalation study in rats. Both are GLP-studies conducted according to OECD guideline 412. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/42712f1f-8563-4eee-a585-62fceff247ca/documents/IUC5-827c0284-384b-4660-a137-4fb53100d33c_e9f44433-7366-40c4-a199-ced72fd0fe51.html,,,,,, 1-(2-butoxy-1-methylethoxy)propan-2-ol,29911-28-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/42712f1f-8563-4eee-a585-62fceff247ca/documents/IUC5-827c0284-384b-4660-a137-4fb53100d33c_e9f44433-7366-40c4-a199-ced72fd0fe51.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,200 mg/m3,,rat 1-(2-butoxy-1-methylethoxy)propan-2-ol,29911-28-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/42712f1f-8563-4eee-a585-62fceff247ca/documents/IUC5-827c0284-384b-4660-a137-4fb53100d33c_e9f44433-7366-40c4-a199-ced72fd0fe51.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat 1-(2-butoxy-1-methylethoxy)propan-2-ol,29911-28-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/42712f1f-8563-4eee-a585-62fceff247ca/documents/IUC5-827c0284-384b-4660-a137-4fb53100d33c_e9f44433-7366-40c4-a199-ced72fd0fe51.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,91 mg/kg bw/day,,rat 1-(2-butoxy-1-methylethoxy)propan-2-ol,29911-28-2,"GLP-studies according to or equivalent to OECD guidelines 401, 403 and 402 (limit test) are available for DPnB. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42712f1f-8563-4eee-a585-62fceff247ca/documents/IUC5-34010725-a1da-426d-bc5d-0c7e4e52b90a_e9f44433-7366-40c4-a199-ced72fd0fe51.html,,,,,, 1-(2-butoxy-1-methylethoxy)propan-2-ol,29911-28-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42712f1f-8563-4eee-a585-62fceff247ca/documents/IUC5-34010725-a1da-426d-bc5d-0c7e4e52b90a_e9f44433-7366-40c4-a199-ced72fd0fe51.html,,oral,LD50,"3,700 mg/kg bw",adverse effect observed, 1-(2-hydroxy-3-sulphonatopropyl)pyridinium,3918-73-8," Repeated dose Toxicity: Subacute study (43-57 days), oral: gavage, Wistar rat m/f, 12 sex/group, 100, 300 and 1000 mg/kg bw/day: NOAEL = 1000 mg/kg bw/d, no toxicologically significant effects observed (read-across from PPS, OECD 422, GLP) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f95888a-372b-41fd-84f7-97eab95f8523/documents/a19fc151-d1d8-4324-939d-c24ff3ba16b4_c53c5221-ccf2-4c96-a1e8-244bcafdb0e7.html,,,,,, 1-(2-hydroxy-3-sulphonatopropyl)pyridinium,3918-73-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f95888a-372b-41fd-84f7-97eab95f8523/documents/a19fc151-d1d8-4324-939d-c24ff3ba16b4_c53c5221-ccf2-4c96-a1e8-244bcafdb0e7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 1-(2-hydroxy-3-sulphonatopropyl)pyridinium,3918-73-8," Acute toxicity oral: LD50 = 5000 mg/kg, Wistar rats, females, 6 dosed with 2000 mg/kg, oral: gavage, no mortality or signs of toxicity occurred (OECD 423, GLP) Acute toxicity oral: LD50 > 5000 mg/kg, LD0≥5000 mg/kg, Wistar rats, m/f, oral: gavage, no mortality occurred (read-across from PPS, OECD 401, GLP) Acute toxicity dermal: LD50 > 2000 mg/kg, LD0≥2000 mg/kg, Sprague-Dawley rats, m/f, 5/sex dose, 2000 mg/kg, semi-occlusive over 24h, no mortality, signs of systemic toxicity or dermal irritation occurred (read-across from PPS, OECD 402, GLP) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f95888a-372b-41fd-84f7-97eab95f8523/documents/2c60839a-172d-45e1-8b5d-04cc8655f8de_c53c5221-ccf2-4c96-a1e8-244bcafdb0e7.html,,,,,, 1-(2-hydroxy-3-sulphonatopropyl)pyridinium,3918-73-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f95888a-372b-41fd-84f7-97eab95f8523/documents/2c60839a-172d-45e1-8b5d-04cc8655f8de_c53c5221-ccf2-4c96-a1e8-244bcafdb0e7.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 1-(2-hydroxy-3-sulphonatopropyl)pyridinium,3918-73-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f95888a-372b-41fd-84f7-97eab95f8523/documents/2c60839a-172d-45e1-8b5d-04cc8655f8de_c53c5221-ccf2-4c96-a1e8-244bcafdb0e7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-(2-hydroxy-5-nonyl(branched)-phenyl)ethanone oxime,244235-47-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d10b76ce-238f-4ab7-8161-4bcee67e4e04/documents/5cd94831-2c63-441c-87a2-efb6aa5b3fcf_a856b092-2a64-4bc1-81b0-2c1416937afa.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat 1-(2-hydroxy-5-nonyl(branched)-phenyl)ethanone oxime,244235-47-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d10b76ce-238f-4ab7-8161-4bcee67e4e04/documents/01064095-d26f-4cb0-b80a-9d45eb05b608_a856b092-2a64-4bc1-81b0-2c1416937afa.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 1-(2-hydroxy-5-nonyl(branched)-phenyl)ethanone oxime,244235-47-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d10b76ce-238f-4ab7-8161-4bcee67e4e04/documents/01064095-d26f-4cb0-b80a-9d45eb05b608_a856b092-2a64-4bc1-81b0-2c1416937afa.html,,dermal,discriminating dose,"2,000 mg/kg bw",adverse effect observed, 1-(2-hydroxyethyl)pyrrolidin-2-one,3445-11-2,"Daily oral administration of the test substance to Han Wistar rats at dose levels up to 1000 mg/kg bw/ day for 13 weeks was well-tolerated, with no evidence of any adverse finding at any of the administered doses. The NOAEL was considered to be 1000 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/423ed7ff-9c9a-4b3b-aa73-863d720bd4ba/documents/IUC5-fd9bc811-b720-40df-8625-38a1018dfdd4_2e749b37-10b7-4639-aa26-7031a6032cec.html,,,,,, 1-(2-hydroxyethyl)pyrrolidin-2-one,3445-11-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/423ed7ff-9c9a-4b3b-aa73-863d720bd4ba/documents/IUC5-fd9bc811-b720-40df-8625-38a1018dfdd4_2e749b37-10b7-4639-aa26-7031a6032cec.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 1-(2-hydroxyethyl)pyrrolidin-2-one,3445-11-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/423ed7ff-9c9a-4b3b-aa73-863d720bd4ba/documents/IUC5-969034ee-b295-45d0-bfa0-47b1f545526f_2e749b37-10b7-4639-aa26-7031a6032cec.html,,oral,discriminating dose,"> 7,300 mg/kg bw",no adverse effect observed, 1-(2-hydroxyethyl)pyrrolidin-2-one,3445-11-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/423ed7ff-9c9a-4b3b-aa73-863d720bd4ba/documents/IUC5-969034ee-b295-45d0-bfa0-47b1f545526f_2e749b37-10b7-4639-aa26-7031a6032cec.html,,dermal,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, "1-(3,5-dichloro-4-fluorophenyl)-2,2,2-trifluoroethan-1-one",1190865-44-1,"Oral: The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat according to OECD 423. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg body weight.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): 1 (reliable without restriction) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9f43cce-855d-4df5-98b9-112f9038ec3d/documents/7180bf7e-cb4e-4c3d-9ceb-95167ed49ec0_17440d3f-e8ec-4863-bd7f-1b7890f3faff.html,,,,,, "1-(3,5-dichloro-4-fluorophenyl)-2,2,2-trifluoroethan-1-one",1190865-44-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9f43cce-855d-4df5-98b9-112f9038ec3d/documents/7180bf7e-cb4e-4c3d-9ceb-95167ed49ec0_17440d3f-e8ec-4863-bd7f-1b7890f3faff.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, 1-(3-chlorophenyl)-4-(3-chloropropyl)piperazine,39577-43-0,LD50 was estimated to be 833 mg/kg bw when rats were orally exposed with 1-(3-chlorophenyl)-4-(3-chloropropyl)piperazine.   ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c26566d-1a20-400d-a966-1c5fcec9485d/documents/943f5b7c-8fa8-4b69-b148-9d3015309cb3_8d92d8a6-2c62-4a20-aa8c-1c912fe4e02d.html,,,,,, 1-(3-chlorophenyl)-4-(3-chloropropyl)piperazine,39577-43-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c26566d-1a20-400d-a966-1c5fcec9485d/documents/943f5b7c-8fa8-4b69-b148-9d3015309cb3_8d92d8a6-2c62-4a20-aa8c-1c912fe4e02d.html,,oral,LD50,833 mg/kg bw,adverse effect observed, 1-(3-chlorophenyl)-4-(3-chloropropyl)piperazinium chloride,52605-52-4,No experimental study is availlable on the substance to evaluate the acute toxicity. A LD50 value was predicted by the software Tox Boxes 2.9. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a572db36-7202-4a48-adfe-9a6ee2069864/documents/IUC5-609cc8ea-1640-4668-ac4d-b6679259ed55_a4a3faa2-810a-4d02-9bb8-65ef1537f4fe.html,,,,,, 1-(3-chlorophenyl)-4-(3-chloropropyl)piperazinium chloride,52605-52-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a572db36-7202-4a48-adfe-9a6ee2069864/documents/IUC5-609cc8ea-1640-4668-ac4d-b6679259ed55_a4a3faa2-810a-4d02-9bb8-65ef1537f4fe.html,,oral,LD50,660 mg/kg bw,adverse effect observed, "1-(3-chloropropyl)-1,3-dihydro-2H-benzimidazol-2-one",62780-89-6," Repeated dose toxicity: oral: The potential toxicity of T001036 after repeated exposure via the oral route was assessed in a 28 days repeated dose toxicity study performed according to OECD Guideline 407 and EU Method B.7 (Braun, 2008). Based on the clinical signs, more specifically ataxia, which was observed at the highest dose level of 300 mg/kg bw/day, it is suggested to consider 100 mg/kg/day as the NOAEL for occupational toxicology (expert statement of the data owner dated 23 -04 -2014). The test substance is therefore classified as STOT RE 2. Repeated dose toxicity: inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Repeated dose toxicity: dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/683fdf88-8700-4211-a1b4-4146613c5aaa/documents/a2142c0b-e780-472f-a158-608cf76173d2_bc2c7026-735d-4f58-9201-0be84892b173.html,,,,,, "1-(3-chloropropyl)-1,3-dihydro-2H-benzimidazol-2-one",62780-89-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/683fdf88-8700-4211-a1b4-4146613c5aaa/documents/a2142c0b-e780-472f-a158-608cf76173d2_bc2c7026-735d-4f58-9201-0be84892b173.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1-(3-chloropropyl)-1,3-dihydro-2H-benzimidazol-2-one",62780-89-6," Acute toxicity: Oral In an acute oral toxicity study in female Crl:WI (Han) (SPF) rats, following the acute toxic class method in accordance with the OECD Guideline 423 and EU Method B.1 tris, the LD50 was established to be within the range of 300 - 2000 mg/kg. According to the OECD 423 guideline, the LD50 cut-off value was considered to be 1000 mg/kg body weight. Acute toxicity: Inhalation No reliable acute toxicity study via the inhalation route was available. However, this endpoint is waived as specific data are available for the oral and dermal exposure routes. Acute toxicity: Dermal In an acute dermal toxicity study in male and female Crl:WI (Han) (SPF) rats, following the standard acute method according to OECD Guideline 402 and EC method B.3, the LD50 was established to exceed 2000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/683fdf88-8700-4211-a1b4-4146613c5aaa/documents/b3d93017-3b01-4055-bd6d-a5676e4edb2f_bc2c7026-735d-4f58-9201-0be84892b173.html,,,,,, "1-(3-chloropropyl)-1,3-dihydro-2H-benzimidazol-2-one",62780-89-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/683fdf88-8700-4211-a1b4-4146613c5aaa/documents/b3d93017-3b01-4055-bd6d-a5676e4edb2f_bc2c7026-735d-4f58-9201-0be84892b173.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, "1-(3-chloropropyl)-1,3-dihydro-2H-benzimidazol-2-one",62780-89-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/683fdf88-8700-4211-a1b4-4146613c5aaa/documents/b3d93017-3b01-4055-bd6d-a5676e4edb2f_bc2c7026-735d-4f58-9201-0be84892b173.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 1-(3-chloropyridin-2-yl)-N-[4-cyano-2-methyl-6-(methylcarbamoyl)phenyl]-3-{[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxamide,1229654-66-3," Subacute repeated dose toxicity, dermal (OECD 410), rat: NOAEL >= 1000 mg/kg bw/day Combined chronic toxicity and carcinogenicity study, oral (OECD 453), rat: NOAEL (12 months) = 4000 ppm (equivalent to 184 and 246 mg/kg bw/day in males and females, respectively), NOAEL (24 months) = 4000 ppm (equivalent to 159 and 221 mg/kg bw/day in males and females, respectively) Subchronic repeated dose toxicity, oral (OECD 408), rat: NOAEL >= 10000 ppm (equivalent to 608 and 723 mg/kg bw/day in males and females, respectively) Subchronic repeated dose toxicity, oral (OECD 409), dog: NOAEL = 3200 ppm (equivalent to 126 and 138 mg/kg bw/day in males and females, respectively) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af382165-f6c2-4ef0-b100-9a9ddb08ae99/documents/224aae3b-7a89-4c0e-b70a-b0ea3f06aafe_43fec137-0387-47f5-9ae2-454adf6e42b3.html,,,,,, 1-(3-chloropyridin-2-yl)-N-[4-cyano-2-methyl-6-(methylcarbamoyl)phenyl]-3-{[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxamide,1229654-66-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af382165-f6c2-4ef0-b100-9a9ddb08ae99/documents/224aae3b-7a89-4c0e-b70a-b0ea3f06aafe_43fec137-0387-47f5-9ae2-454adf6e42b3.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat 1-(3-chloropyridin-2-yl)-N-[4-cyano-2-methyl-6-(methylcarbamoyl)phenyl]-3-{[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxamide,1229654-66-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af382165-f6c2-4ef0-b100-9a9ddb08ae99/documents/224aae3b-7a89-4c0e-b70a-b0ea3f06aafe_43fec137-0387-47f5-9ae2-454adf6e42b3.html,Chronic toxicity – systemic effects,oral,NOAEL,159 mg/kg bw/day,,rat 1-(3-chloropyridin-2-yl)-N-[4-cyano-2-methyl-6-(methylcarbamoyl)phenyl]-3-{[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxamide,1229654-66-3," Oral (OECD 423), rat: LD50 > 2000 mg/kg bw Inhalation (OECD 403), rat: LC50 > 5.01 mg/L air Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af382165-f6c2-4ef0-b100-9a9ddb08ae99/documents/19330aa1-0882-48e6-b7bc-640aa4dad0f7_43fec137-0387-47f5-9ae2-454adf6e42b3.html,,,,,, 1-(3-chloropyridin-2-yl)-N-[4-cyano-2-methyl-6-(methylcarbamoyl)phenyl]-3-{[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxamide,1229654-66-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af382165-f6c2-4ef0-b100-9a9ddb08ae99/documents/19330aa1-0882-48e6-b7bc-640aa4dad0f7_43fec137-0387-47f5-9ae2-454adf6e42b3.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-(3-chloropyridin-2-yl)-N-[4-cyano-2-methyl-6-(methylcarbamoyl)phenyl]-3-{[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxamide,1229654-66-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af382165-f6c2-4ef0-b100-9a9ddb08ae99/documents/19330aa1-0882-48e6-b7bc-640aa4dad0f7_43fec137-0387-47f5-9ae2-454adf6e42b3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-(3-chloropyridin-2-yl)-N-[4-cyano-2-methyl-6-(methylcarbamoyl)phenyl]-3-{[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxamide,1229654-66-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af382165-f6c2-4ef0-b100-9a9ddb08ae99/documents/19330aa1-0882-48e6-b7bc-640aa4dad0f7_43fec137-0387-47f5-9ae2-454adf6e42b3.html,,inhalation,LC50,5.01 mg/m3,adverse effect observed, 1-(3-methoxyphenyl)ethanamine,62409-13-6,The oral LD50 of rac-1-(3-Methoxyphenyl)ethylamine was between 300 and 2000 mg/kg bw (OECD 423). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df21c904-9a57-401e-8f1a-f03738929ac4/documents/IUC5-2c636e3f-9493-46cf-81b9-d11cb022079c_1d6bea7f-26fc-4390-8707-56c755884572.html,,,,,, 1-(3-sulphonatopropyl)pyridinium,15471-17-7,"No mortality and clinical signs were detected in treated animals. Body weight, food consumption, haematology and blood chemistry parameters were comparable to controls. Behavioural parameters, functional performance and sensor reactivity were not affected. There were no treatment-related effects on mating, fertility and gestation lenghts for treated animals. No clinically observable signs of toxicity were detected for offspring from all treatment groups. Litters size, sex ratio, body weight development and surface righting reflex were not affected. No findings at necropsy were detected in adults and offspring. NOAEL of 1000 mg/kg bw, the highest dose level tested, was established for systemic toxicity and for reproductive performance. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9f603bf-fff9-453a-afd0-2536ba271560/documents/IUC5-63f093f0-cfed-4c9e-b019-23ec3b64b7d5_9861d650-8b2a-4c0c-b512-580f5262d55c.html,,,,,, 1-(3-sulphonatopropyl)pyridinium,15471-17-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9f603bf-fff9-453a-afd0-2536ba271560/documents/IUC5-63f093f0-cfed-4c9e-b019-23ec3b64b7d5_9861d650-8b2a-4c0c-b512-580f5262d55c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 1-(3-sulphonatopropyl)pyridinium,15471-17-7,"1. Acute oral toxicity (1983), GLP, OECD 401, rats, gavage, 1000 mg/kg, 5000 mg/kg, LD50 >5000 mg/kg bw.2. Acute dermal toxicity (2001), GLP, OECD 402, rats, semiocclusive, 2000 mg/kg, LD50 > 2000 mg/kg bw.3. Prediction using TOXTREE (v.2.5.0), Chemservice S.A., 2011) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9f603bf-fff9-453a-afd0-2536ba271560/documents/IUC5-7c370613-151e-4795-bc78-c9b5506fc153_9861d650-8b2a-4c0c-b512-580f5262d55c.html,,,,,, 1-(3-sulphonatopropyl)pyridinium,15471-17-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9f603bf-fff9-453a-afd0-2536ba271560/documents/IUC5-7c370613-151e-4795-bc78-c9b5506fc153_9861d650-8b2a-4c0c-b512-580f5262d55c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 1-(3-sulphonatopropyl)pyridinium,15471-17-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9f603bf-fff9-453a-afd0-2536ba271560/documents/IUC5-7c370613-151e-4795-bc78-c9b5506fc153_9861d650-8b2a-4c0c-b512-580f5262d55c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-(4,7-dihydro-5H-thieno[2,3-c]pyran-7-yl)- N-methylmethanamine trifluoromethansulfonate",2374784-45-7," No data on intermediate 1-(5,7-dihydro-4H-thieno[2,3-c]pyran-7-yl)-N-methylmethanamine triflate. The available information is for the free base. Oral-dose studies in mice, rats, and dogs over durations of 28 days, 6 and 9 months, respectively are available. In mice, the substance (≤100 mg/kg/day) was generally well tolerated except for limited mortality in females. In rats and dogs, there were clinical observations consistent with CNS activity including dilated pupils (dogs only), increased or decreased activity, impaired coordination, hypersensitivity to touch, salivation, vocalization, lacrimation, and tremor. Convulsions were sporadically noted at >60 mg/kg/day in rats and at 15 mg/kg/day as single instance of self-limiting intermittent convulsions in a female dog. In rats, low body weight gains were noted throughout the dosing period. In dogs, an increased incidence and severity of clinical observations consistent with CNS activity occurred at ≥2.5 mg/kg/day. The NOAELs were 100 and 50 mg/kg/day in male and female mice, 15 mg/kg/day in rats, and 10 mg/kg/day in dogs. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df9152cd-4ca9-436f-a7d1-2a03d7a676b0/documents/eefc8722-f18a-4043-9293-3ad0af4b72c3_cc84d001-f3dc-44cc-8b1d-8c03e93ae574.html,,,,,, "1-(4,7-dihydro-5H-thieno[2,3-c]pyran-7-yl)- N-methylmethanamine trifluoromethansulfonate",2374784-45-7," No data on intermediate 1-(5,7-dihydro-4H-thieno[2,3-c]pyran-7-yl)-N-methylmethanamine triflate. The available information is for the free base. In rats, single oral dose (≥100 mg/kg) caused increased vocalization and urination, and reduced grooming. In addition, impaired coordination, splayed limbs, vocalization, salivation, bristling of hairs, decreased activity, tremors, and death were reported at 600 mg/kg. In mice, 100 mg/kg was the maximum tolerated dose and a single dose of ≥150 mg/kg was lethal. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df9152cd-4ca9-436f-a7d1-2a03d7a676b0/documents/2eccc0e5-15c3-40ad-85d9-764e581c3645_cc84d001-f3dc-44cc-8b1d-8c03e93ae574.html,,,,,, 1-(4-METHOXYPHENYL)-4-(4-NITROPHENYL)PIPERAZINE,74852-61-2," Repeated dose toxicity - oral: In a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the test substance was administered daily to rats up to a dose level of 1000 mg/kg body weight/day (OECD 422; van Otterdijk, 2016). The NOAEL is established as at least 1000 mg/kg body weight/day. The substance is therefore not classified as STOT RE 2, according to CLP Regulation. Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e12b067f-5d18-4710-859d-d6e9b52c9d5a/documents/99185ea8-d8b0-4e13-a3eb-75f7418afed2_882a8a48-7131-4bbe-8bc1-7eebefd961e8.html,,,,,, 1-(4-METHOXYPHENYL)-4-(4-NITROPHENYL)PIPERAZINE,74852-61-2,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e12b067f-5d18-4710-859d-d6e9b52c9d5a/documents/99185ea8-d8b0-4e13-a3eb-75f7418afed2_882a8a48-7131-4bbe-8bc1-7eebefd961e8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 1-(4-METHOXYPHENYL)-4-(4-NITROPHENYL)PIPERAZINE,74852-61-2," Acute toxicity: Oral In an acute oral toxicity study in female Crl:WI (Han) (SPF) rats, following the acute toxic class method in accordance with the OECD Guideline 423 and EU Method B.1 tris, the LD50 was established to exceed 2000 mg/kg. According to the OECD 423 guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. Acute toxicity: Inhalation No reliable acute toxicity study via the inhalation route was available. However, this endpoint is waived as specific data are available for the oral and dermal exposure routes. Acute toxicity: Dermal In an acute dermal toxicity study in male and female Crl:WI (Han) (SPF) rats, following the standard acute method according to OECD Guideline 402 and EC method B.3, the LD50 was established to exceed 2000 mg/kg body weight. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e12b067f-5d18-4710-859d-d6e9b52c9d5a/documents/4b0c0ae1-3f9b-4a9b-b1ae-b6e07067860c_882a8a48-7131-4bbe-8bc1-7eebefd961e8.html,,,,,, 1-(4-METHOXYPHENYL)-4-(4-NITROPHENYL)PIPERAZINE,74852-61-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e12b067f-5d18-4710-859d-d6e9b52c9d5a/documents/4b0c0ae1-3f9b-4a9b-b1ae-b6e07067860c_882a8a48-7131-4bbe-8bc1-7eebefd961e8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-(4-METHOXYPHENYL)-4-(4-NITROPHENYL)PIPERAZINE,74852-61-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e12b067f-5d18-4710-859d-d6e9b52c9d5a/documents/4b0c0ae1-3f9b-4a9b-b1ae-b6e07067860c_882a8a48-7131-4bbe-8bc1-7eebefd961e8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-(4-Methoxyphenyl)ethanamine,6298-96-0,"The oral LD50 of rac-1-(3-Methoxyphenyl)ethylamine (read across, CAS 62409-13-6) was between 300 and 2000 mg/kg bw (OECD 423). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a3bf78d-9c9b-4267-88f8-ec96e82fcda6/documents/IUC5-2ab86d8a-0a3e-40e4-ab9d-6d9bafddc793_1647bfcf-434b-4599-9642-2b5c157f48da.html,,,,,, 1-(4-trans-Pentylcyclohexyl)-4-propylbenzene,82991-48-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38361270-b895-429c-9a4b-c778d191aa21/documents/IUC5-3aaa41f8-ec82-4aab-a9d8-cdc4361b0642_c80ee989-9c66-46f4-843f-e26c4246555a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Benzene, 1-[(trans,trans)-4'-propyl[1,1'-bicyclohexyl]-4-yl]-4-(trifluoromethoxy)-",133937-72-1,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2c58f3e-7ab2-4b74-830a-3a0778f0e5bc/documents/453d7307-2d6f-473e-9af8-fe9dff0ffc3f_8c8fedc8-2c94-4df4-910a-3f05bf5f4b1b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,6 mg/kg bw/day,,rat "Benzene, 1-[(trans,trans)-4'-propyl[1,1'-bicyclohexyl]-4-yl]-4-(trifluoromethoxy)-",133937-72-1," The acute oral toxicity of the test item was determined in a limit test according to OECD Guideline 401 under GLP conditions. No adverse effects were observed up to the highest concentration of 2000 mg/kg bw. Therefore, the LD50 of the test item is greater than 2000 mg/kg bw. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2c58f3e-7ab2-4b74-830a-3a0778f0e5bc/documents/d050f33c-2d12-4884-9f4d-470d6abd3109_8c8fedc8-2c94-4df4-910a-3f05bf5f4b1b.html,,,,,, "Benzene, 1-[(trans,trans)-4'-propyl[1,1'-bicyclohexyl]-4-yl]-4-(trifluoromethoxy)-",133937-72-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2c58f3e-7ab2-4b74-830a-3a0778f0e5bc/documents/d050f33c-2d12-4884-9f4d-470d6abd3109_8c8fedc8-2c94-4df4-910a-3f05bf5f4b1b.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1-(5,6,7,8-tetrahydro-2-naphthyl)ethan-1-one",774-55-0," Acute Toxicity: Oral: According to the study, the acute oral median lethal dasage (LD50) calculated by probit analysis, were: Rats: - male: 2600 mg/kg - female: 2700 mg/kg - combined sexes: 2650 mg/kg Mice: - male: 3000 mg/kg - female: 2900 mg/kg - combined sexes: 2950 mg/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28e06e54-3a7c-4120-bdce-cb4c414e7021/documents/21ad2079-7912-4623-aa9e-c1fba60a9ae4_9d796114-7aed-42c8-af51-88931b017032.html,,,,,, "1-(5,6,7,8-tetrahydro-2-naphthyl)ethan-1-one",774-55-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28e06e54-3a7c-4120-bdce-cb4c414e7021/documents/21ad2079-7912-4623-aa9e-c1fba60a9ae4_9d796114-7aed-42c8-af51-88931b017032.html,,oral,LD50,"2,650 mg/kg bw",no adverse effect observed, "1-(5,6-dihydrobenzo[b][1]benzazepin-11-yl)ethanone",13080-75-6," The predicted oral LD50 of the substance is 1981,52 mg/kg by Consensus method. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1093bc3-c118-45e3-acc3-e4201d9dda0c/documents/a52101a7-e1ca-42f6-a497-277377739133_ef6a6bcd-d159-44bc-a54d-2f63587f8c36.html,,,,,, 1-(5-ethyl-5-methylcyclohex-1-en-1-yl)pent-4-en-1-one,1393645-32-3," Oral: NOAEL (rat): 500 mg/kg body weight per day ; male/female, OECD TG 407, 2015 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8509f63-9a12-4984-9d1b-c4d9d88cc34a/documents/df722723-65a8-472c-a04c-8497fbf68047_6764bcd0-ff1e-4bec-9c12-ce39c65decb8.html,,,,,, 1-(5-ethyl-5-methylcyclohex-1-en-1-yl)pent-4-en-1-one,1393645-32-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8509f63-9a12-4984-9d1b-c4d9d88cc34a/documents/df722723-65a8-472c-a04c-8497fbf68047_6764bcd0-ff1e-4bec-9c12-ce39c65decb8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat 1-(5-ethyl-5-methylcyclohex-1-en-1-yl)pent-4-en-1-one,1393645-32-3," Oral: measured LD50 > 300 and < 2000 mg/kg bw and the estimated LD50 cut-off was considered to be 1000 mg/kg bw, female rat, OECD TG 423, 2015 Inhalation: measured LC50 > 6.43 mg/L (mean achieved concentration), male/female rat, OECD TG 403, 2015 Dermal: measured LD50 > 2000 mg/kg bw and the estimated LD50 cut-off value was considered to be > 5000 mg/kg bw, male/female rat, OECD TG 402, 2015 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8509f63-9a12-4984-9d1b-c4d9d88cc34a/documents/45225b07-dd58-417f-8366-3fa5987153ce_6764bcd0-ff1e-4bec-9c12-ce39c65decb8.html,,,,,, 1-(5-ethyl-5-methylcyclohex-1-en-1-yl)pent-4-en-1-one,1393645-32-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8509f63-9a12-4984-9d1b-c4d9d88cc34a/documents/45225b07-dd58-417f-8366-3fa5987153ce_6764bcd0-ff1e-4bec-9c12-ce39c65decb8.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, 1-(5-ethyl-5-methylcyclohex-1-en-1-yl)pent-4-en-1-one,1393645-32-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8509f63-9a12-4984-9d1b-c4d9d88cc34a/documents/45225b07-dd58-417f-8366-3fa5987153ce_6764bcd0-ff1e-4bec-9c12-ce39c65decb8.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 1-(5-ethyl-5-methylcyclohex-1-en-1-yl)pent-4-en-1-one,1393645-32-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8509f63-9a12-4984-9d1b-c4d9d88cc34a/documents/45225b07-dd58-417f-8366-3fa5987153ce_6764bcd0-ff1e-4bec-9c12-ce39c65decb8.html,,inhalation,discriminating conc.,"6,430 mg/m3",no adverse effect observed, "1-(5-propyl-1,3-benzodioxol-2-yl)-1-ethanone",1370699-98-1," Repeated dose toxicity oral: NOAEL = 300 mg/kg bw/d (OECD 407, GLP, K, rel. 1) ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f684a77b-0af1-4222-ae87-9dfc615028ab/documents/2434d412-e8e7-4bc3-b15a-941dd29e6c44_12d20747-deea-4f74-aec7-c7654e2ab434.html,,,,,, "1-(5-propyl-1,3-benzodioxol-2-yl)-1-ethanone",1370699-98-1,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f684a77b-0af1-4222-ae87-9dfc615028ab/documents/2434d412-e8e7-4bc3-b15a-941dd29e6c44_12d20747-deea-4f74-aec7-c7654e2ab434.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "1-(5-propyl-1,3-benzodioxol-2-yl)-1-ethanone",1370699-98-1," Oral LD50 (rat/female) > 2000 mg/kg bw (OECD 423, K, rel.1) Dermal LD50 (rat/combined) > 2000 mg/kg bw (OECD 402, K, rel.1) Inhalation LC50 (rat/combined) > 5.97 mg/L = 5970 mg/m3 (OECD 403, K, rel.1) ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f684a77b-0af1-4222-ae87-9dfc615028ab/documents/9d79f6be-b1a5-4dcb-b17c-37d90f18a4d3_12d20747-deea-4f74-aec7-c7654e2ab434.html,,,,,, "1-(5-propyl-1,3-benzodioxol-2-yl)-1-ethanone",1370699-98-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f684a77b-0af1-4222-ae87-9dfc615028ab/documents/9d79f6be-b1a5-4dcb-b17c-37d90f18a4d3_12d20747-deea-4f74-aec7-c7654e2ab434.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "1-(5-propyl-1,3-benzodioxol-2-yl)-1-ethanone",1370699-98-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f684a77b-0af1-4222-ae87-9dfc615028ab/documents/9d79f6be-b1a5-4dcb-b17c-37d90f18a4d3_12d20747-deea-4f74-aec7-c7654e2ab434.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-(5-propyl-1,3-benzodioxol-2-yl)-1-ethanone",1370699-98-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f684a77b-0af1-4222-ae87-9dfc615028ab/documents/9d79f6be-b1a5-4dcb-b17c-37d90f18a4d3_12d20747-deea-4f74-aec7-c7654e2ab434.html,,inhalation,LC50,"5,970 mg/m3",adverse effect observed, 1-(6-methoxy-2-naphthyl)ethan-1-one,3900-45-6,The substance 1-(6-methoxy-2-naphthyl)ethan-1-one is not toxic by any of the following route. ,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/55ccee47-2eaa-470c-9504-75aeb57ab291/documents/IUC5-2b3b24de-1763-4ff6-8bce-5483acdc2533_7ecb3393-ee03-4453-9cad-d701d4b01099.html,,,,,, 1-(6-methoxy-2-naphthyl)ethan-1-one,3900-45-6,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/55ccee47-2eaa-470c-9504-75aeb57ab291/documents/IUC5-2b3b24de-1763-4ff6-8bce-5483acdc2533_7ecb3393-ee03-4453-9cad-d701d4b01099.html,Sub-chronic toxicity – systemic effects,oral,,133.33 mg/kg bw/day,,rat 1-(6-methoxy-2-naphthyl)ethan-1-one,3900-45-6,"The substance 1-(6-methoxy-2-naphthyl)ethan-1-one is not toxic by any of the following route (Oral, inhalation dermal)of exposure. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55ccee47-2eaa-470c-9504-75aeb57ab291/documents/IUC5-beafafec-5cd0-49cd-ad2d-dd8f6c03c616_7ecb3393-ee03-4453-9cad-d701d4b01099.html,,,,,, 1-(6-methoxy-2-naphthyl)ethan-1-one,3900-45-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55ccee47-2eaa-470c-9504-75aeb57ab291/documents/IUC5-beafafec-5cd0-49cd-ad2d-dd8f6c03c616_7ecb3393-ee03-4453-9cad-d701d4b01099.html,,oral,LD50,"2,246.02 mg/kg bw",no adverse effect observed, 1-(6-methoxy-2-naphthyl)ethan-1-one,3900-45-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55ccee47-2eaa-470c-9504-75aeb57ab291/documents/IUC5-beafafec-5cd0-49cd-ad2d-dd8f6c03c616_7ecb3393-ee03-4453-9cad-d701d4b01099.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, 1-(carboxylatomethyl)methylpyridinium,85650-88-0, Based on results obtained with the read-across substance the oral median LD50 is considered to be greater than 5000 mg/kg bw in the rat. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef2a4155-2879-49b1-822c-5c0350d09d9b/documents/19dcb740-d538-41d3-a933-4aa035409a08_5229cf77-7182-457f-9e27-69fae6c3edde.html,,,,,, 1-(carboxylatomethyl)methylpyridinium,85650-88-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef2a4155-2879-49b1-822c-5c0350d09d9b/documents/19dcb740-d538-41d3-a933-4aa035409a08_5229cf77-7182-457f-9e27-69fae6c3edde.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, 1-(chloromethyl)naphthalene,86-52-2, Acute toxicity oral in rat was reported as LD50 890 mg/kg. Acute toxicity dermal in rabbit was reported as LD50 2000 mg/kg. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9d25f7a-8365-4930-a404-3d26a1f0eefd/documents/6f852767-ea03-4986-bc0f-20f1a1397d54_4af23673-deea-40a2-a905-edc5f1429967.html,,,,,, 1-(chloromethyl)naphthalene,86-52-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9d25f7a-8365-4930-a404-3d26a1f0eefd/documents/6f852767-ea03-4986-bc0f-20f1a1397d54_4af23673-deea-40a2-a905-edc5f1429967.html,,oral,LD50,890 mg/kg bw,adverse effect observed, 1-(chloromethyl)naphthalene,86-52-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9d25f7a-8365-4930-a404-3d26a1f0eefd/documents/6f852767-ea03-4986-bc0f-20f1a1397d54_4af23673-deea-40a2-a905-edc5f1429967.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, 1-(methylamino)-4-[(3-methylphenyl)amino]anthraquinone,6408-50-0,The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e8b6032-774c-4b81-ba70-ba698289f666/documents/da9a42d7-5f3b-4cce-9bb4-a9928cabf00b_803ff8b6-0a75-4a25-99e7-6f79885a21b2.html,,,,,, 1-(methylamino)-4-[(3-methylphenyl)amino]anthraquinone,6408-50-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e8b6032-774c-4b81-ba70-ba698289f666/documents/da9a42d7-5f3b-4cce-9bb4-a9928cabf00b_803ff8b6-0a75-4a25-99e7-6f79885a21b2.html,,oral,LD50,"> 2,000 mg/kg bw",adverse effect observed, "1-(N,N-bis(2-ethylhexyl)aminomethyl)-1,2,4-triazole",91273-04-0,"In a 28-day repeated dose toxicity study in rats, the test article caused mortality and gastric irritation at the high dose level (200 mg/kg bw) due to its corrosivity and the NOEL was determined at 60 mg/kg body weight per day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c004f2df-2041-4227-bad7-ccfd199a1a88/documents/a03a49de-eb9a-4df4-b4d8-54d926c952b1_db0fc283-815e-44e6-9671-670002644742.html,,,,,, "1-(N,N-bis(2-ethylhexyl)aminomethyl)-1,2,4-triazole",91273-04-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c004f2df-2041-4227-bad7-ccfd199a1a88/documents/a03a49de-eb9a-4df4-b4d8-54d926c952b1_db0fc283-815e-44e6-9671-670002644742.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat "1-(N,N-bis(2-ethylhexyl)aminomethyl)-1,2,4-triazole",91273-04-0," Acute oral toxicity (OECD guideline 401): LD50 = 2356 mg/kg bw (CIBA-GEIGY Ltd., 850292, 1985) Acute dermal toxicity (OECD guideline 402): LD50 > 2000 mg/kg bw (CIBA-GEIGY Ltd., 850295, 1985) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c004f2df-2041-4227-bad7-ccfd199a1a88/documents/80f7073c-fe3a-4659-b238-9d414c3345af_db0fc283-815e-44e6-9671-670002644742.html,,,,,, "1-(N,N-bis(2-ethylhexyl)aminomethyl)-1,2,4-triazole",91273-04-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c004f2df-2041-4227-bad7-ccfd199a1a88/documents/80f7073c-fe3a-4659-b238-9d414c3345af_db0fc283-815e-44e6-9671-670002644742.html,,oral,LD50,"2,356 mg/kg bw",adverse effect observed, "1-(N,N-bis(2-ethylhexyl)aminomethyl)-1,2,4-triazole",91273-04-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c004f2df-2041-4227-bad7-ccfd199a1a88/documents/80f7073c-fe3a-4659-b238-9d414c3345af_db0fc283-815e-44e6-9671-670002644742.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol",6712-98-7,"In a GLP study, conducted according to OECD Guideline 407, a NOAEL of 100 mg/kg bw/day has been determined in the rat for DEIPA, following gavage administration for 28 days (Stebbins and Zablotny, 1999).In a FDA guideline study to GLP, the repeated dose toxicity of TIPA was investigated in rats (F1 offspring) during a 90-day feeding study. The parental group had previously been exposed to TIPA for 5 wk prior to pairing, throughout mating, gestation and lactation. Since no significant treatment-related effects were seen at any dose level at the end of the 90-day exposure period, a NOAEL of 7500 ppm (about 609 mg/kg bw/day for males and 700 mg/kg bw/day for females) was determined (Mullin, 1988). Although a higher NOAEL was seen in the reliable 90-day study with TIPA, as this was on a read-across material, it was considered health precautionary to base any subsequent assessment on the NOAEL of 100 mg/kg bw/day seen in the 28-day study with DEIPA. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1069a721-bd41-4c47-88d8-74ef76c0ed55/documents/IUC5-8d197d4a-96c1-4339-89e9-f435ff842a1c_5f6776d7-f1e5-4704-8f99-dce4db8d1b15.html,,,,,, "1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol",6712-98-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1069a721-bd41-4c47-88d8-74ef76c0ed55/documents/IUC5-8d197d4a-96c1-4339-89e9-f435ff842a1c_5f6776d7-f1e5-4704-8f99-dce4db8d1b15.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol",6712-98-7," In a GLP study conducted according to OECD Guideline 401, an acute oral LD50 of greater than 2000 mg/kg bw (limit test) was determined for DEIPA in rats (Stebbins and Brooks, 1999a). In a poorly-reported acute inhalation study, no deaths were seen following exposure of 6 male rats to DEIPA saturated air (16.4 mg/L) for 7 hours. An acute inhalation LC50 of greater than 16.4 mg/L [about 16,400 mg/m3] can be determined (Vaughn et al. 1975). In a GLP study, conducted according to OECD Guideline 402, an acute dermal LD50 of greater than 2000 mg/kg bw (limit test) was determined for DEIPA in New Zealand White rabbits (Stebbins and Brooks, 1999b). Overall, NICNAS (2009) considered DEIPA to be of low acute toxicity via the oral, dermal and inhalation routes. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1069a721-bd41-4c47-88d8-74ef76c0ed55/documents/IUC5-82016f6b-8f0f-47b3-8211-cac3f0af6e68_5f6776d7-f1e5-4704-8f99-dce4db8d1b15.html,,,,,, "1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol",6712-98-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1069a721-bd41-4c47-88d8-74ef76c0ed55/documents/IUC5-82016f6b-8f0f-47b3-8211-cac3f0af6e68_5f6776d7-f1e5-4704-8f99-dce4db8d1b15.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol",6712-98-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1069a721-bd41-4c47-88d8-74ef76c0ed55/documents/IUC5-82016f6b-8f0f-47b3-8211-cac3f0af6e68_5f6776d7-f1e5-4704-8f99-dce4db8d1b15.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-(N,N-bis(2-hydroxyethyl)amino)propan-2-ol",6712-98-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1069a721-bd41-4c47-88d8-74ef76c0ed55/documents/IUC5-82016f6b-8f0f-47b3-8211-cac3f0af6e68_5f6776d7-f1e5-4704-8f99-dce4db8d1b15.html,,inhalation,LC50,"16,400 mg/m3",no adverse effect observed, 1-(tert-dodecylthio)propan-2-ol,67124-09-8,NOAEL for systemic toxicity was determined to be 167 mg/kg/day based on an one-generation study in rats. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de5b0733-e2b5-4e26-a104-7e9e7af830e8/documents/47d4da75-0a38-4ef1-a3f1-065e5d607c50_93874f33-e6f1-4ef1-80d0-dfbdec87b429.html,,,,,, 1-(tert-dodecylthio)propan-2-ol,67124-09-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de5b0733-e2b5-4e26-a104-7e9e7af830e8/documents/47d4da75-0a38-4ef1-a3f1-065e5d607c50_93874f33-e6f1-4ef1-80d0-dfbdec87b429.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,167 mg/kg bw/day,,rat 1-(tert-dodecylthio)propan-2-ol,67124-09-8,Acute oral toxicity: LD50 (rat) > 5000 mg/kg bwAcute dermal toxicity: LD50 (rabbit) > 2000 mg/kg bwAcute inhalation toxicity: No study available ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de5b0733-e2b5-4e26-a104-7e9e7af830e8/documents/cea11dfa-7a96-47fb-8a61-55921d331e4f_93874f33-e6f1-4ef1-80d0-dfbdec87b429.html,,,,,, 1-(tert-dodecylthio)propan-2-ol,67124-09-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de5b0733-e2b5-4e26-a104-7e9e7af830e8/documents/cea11dfa-7a96-47fb-8a61-55921d331e4f_93874f33-e6f1-4ef1-80d0-dfbdec87b429.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, 1-(tert-dodecylthio)propan-2-ol,67124-09-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de5b0733-e2b5-4e26-a104-7e9e7af830e8/documents/cea11dfa-7a96-47fb-8a61-55921d331e4f_93874f33-e6f1-4ef1-80d0-dfbdec87b429.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 1-(vinyloxy)dodecane,765-14-0,An acute oral LD50 was determined to be > 2000 mg/kg bw in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f49be3a-4727-4e55-aeb0-177eed1d3699/documents/IUC5-2aa146fe-2a50-4715-9114-614623ca980f_8e0a57b4-7e6d-4a58-ac05-bd754dfc703c.html,,,,,, 1-(vinyloxy)dodecane,765-14-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f49be3a-4727-4e55-aeb0-177eed1d3699/documents/IUC5-2aa146fe-2a50-4715-9114-614623ca980f_8e0a57b4-7e6d-4a58-ac05-bd754dfc703c.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 1-(vinyloxy)octadecane,930-02-9, Under the conditions of this OECD 408 repeated dose toxicity test in Wistar rats the NOAEL was 200 mg/kg bw/d for male and 50 mg/kg bw/d bw/day for female animals. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54b50f57-2797-4892-a1d1-4c5a5b777528/documents/IUC5-5bfbc8a8-6364-478e-8d11-9fbffb47ee16_51cbcd81-03af-464c-a018-37984b749e0e.html,,,,,, 1-(vinyloxy)octadecane,930-02-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54b50f57-2797-4892-a1d1-4c5a5b777528/documents/IUC5-5bfbc8a8-6364-478e-8d11-9fbffb47ee16_51cbcd81-03af-464c-a018-37984b749e0e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 1-(vinyloxy)octadecane,930-02-9,Oral: The acute oral LD50 of 1-(vinyloxy)octadecane was determined to be greater than 5000 mg/kg bw in rats.Dermal: The median lethal dose (LD50) of 1-(vinyloxy)octadecane after dermal application was found to be greater than 5000 mg/kg bw in male and female rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54b50f57-2797-4892-a1d1-4c5a5b777528/documents/IUC5-8cbb5c4f-a1a0-45f6-befc-c09537b267e0_51cbcd81-03af-464c-a018-37984b749e0e.html,,,,,, 1-(vinyloxy)octadecane,930-02-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54b50f57-2797-4892-a1d1-4c5a5b777528/documents/IUC5-8cbb5c4f-a1a0-45f6-befc-c09537b267e0_51cbcd81-03af-464c-a018-37984b749e0e.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, 1-(vinyloxy)octadecane,930-02-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54b50f57-2797-4892-a1d1-4c5a5b777528/documents/IUC5-8cbb5c4f-a1a0-45f6-befc-c09537b267e0_51cbcd81-03af-464c-a018-37984b749e0e.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "1,1'-(1,1,2,2-tetramethylethylene)dibenzene",1889-67-4,"Based on the results of the 90-day repeated dose toxicity study, the NOAEL was determined to be 10 mg/kg bw/day for male and female Wistar rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bca25f8a-9cc6-45f2-acf1-2bb5ac5f687a/documents/3b8c708c-13b8-431b-b376-4aad095e274d_de6ea843-8b88-4551-b87a-8ceb1df78abe.html,,,,,, "1,1'-(1,1,2,2-tetramethylethylene)dibenzene",1889-67-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bca25f8a-9cc6-45f2-acf1-2bb5ac5f687a/documents/3b8c708c-13b8-431b-b376-4aad095e274d_de6ea843-8b88-4551-b87a-8ceb1df78abe.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "1,1'-(1,1,2,2-tetramethylethylene)dibenzene",1889-67-4," Oral: The LD50 of 1,1'-(1,1,2,2-tetramethylethylene)dibenzene in the rat after oral administration (gavage) is greater than 2000 mg/kg bw. Dermal: No local or systemic toxic effects related to administration of the test substance were noted from clinical observations or post-mortem-examination at a dose of 2000 mg of the test substance per kg body weight. No mortality occurred. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bca25f8a-9cc6-45f2-acf1-2bb5ac5f687a/documents/3c7e1b70-4bdd-41dc-8045-1fb43cee96b5_de6ea843-8b88-4551-b87a-8ceb1df78abe.html,,,,,, "1,1'-(1,1,2,2-tetramethylethylene)dibenzene",1889-67-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bca25f8a-9cc6-45f2-acf1-2bb5ac5f687a/documents/3c7e1b70-4bdd-41dc-8045-1fb43cee96b5_de6ea843-8b88-4551-b87a-8ceb1df78abe.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,1'-(1,1,2,2-tetramethylethylene)dibenzene",1889-67-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bca25f8a-9cc6-45f2-acf1-2bb5ac5f687a/documents/3c7e1b70-4bdd-41dc-8045-1fb43cee96b5_de6ea843-8b88-4551-b87a-8ceb1df78abe.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,1'-(1,1,3-trimethylpropane-1,3-diyl)bis(cyclohexane)",38970-72-8, Dermal administration of the test item on rats produced no significant observations of systemic toxicity. A no effect level for dermal irritation was not established in this study and thus is considered to be below 0.03 mL/kg/day (ca. 26.7 mg/kg bw/day). ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fea2057b-5000-4339-a728-f4fc583e9064/documents/fa83d014-fe41-42d4-80d3-41fd067eed06_64992556-a3a9-4877-9b6f-0c5be9f1c911.html,,,,,, "1,1'-(1,1,3-trimethylpropane-1,3-diyl)bis(cyclohexane)",38970-72-8," The oral LD50 value of 1,1’-(1,1,3-trimethylpropane-1,3-diyl)bis(cyclohexane) in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fea2057b-5000-4339-a728-f4fc583e9064/documents/c7c81f62-f637-4284-a756-346800fd26d8_64992556-a3a9-4877-9b6f-0c5be9f1c911.html,,,,,, "1,1'-(1,1,3-trimethylpropane-1,3-diyl)bis(cyclohexane)",38970-72-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fea2057b-5000-4339-a728-f4fc583e9064/documents/c7c81f62-f637-4284-a756-346800fd26d8_64992556-a3a9-4877-9b6f-0c5be9f1c911.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "1,1'-(1,1-dimethyl-3-methylene-1,3-propanediyl)bisbenzene",6362-80-7," 90 -Day Repeat Dose Toxicity Study: It was concluded, following 13 weeks of oral gavage administration of NOFMER MSD to Sprague-Dawley rats at doses of 100, 300 or 800 mg/kg/day that the no-adverse-effect-level (NOAEL) was 800 mg/kg/day; it was not possible to determine the no-observed-effect-level (NOEL). 28 day repeat dose oral toxicity study combined with a reproductive/ developmental toxicity screening test: The NOEL of the test material for male and female rats can be considered as <45 mg/kg bw and 45 mg/kg bw, respectively. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f115b6e-c79b-4283-8013-ab4e27c55e81/documents/IUC5-16a598b7-b3b1-45e7-9504-6ea90964482e_be4e32ac-0357-42bc-a32a-ae780267878d.html,,,,,, "1,1'-(1,1-dimethyl-3-methylene-1,3-propanediyl)bisbenzene",6362-80-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f115b6e-c79b-4283-8013-ab4e27c55e81/documents/IUC5-16a598b7-b3b1-45e7-9504-6ea90964482e_be4e32ac-0357-42bc-a32a-ae780267878d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,800 mg/kg bw/day,,rat "1,1'-(1,1-dimethyl-3-methylene-1,3-propanediyl)bisbenzene",6362-80-7, Acute oral toxicity: The LD50 value of the test item was estimated to be between 300 mg/kg and 2000 mg/kg. Acute inhalation toxicity: . The acute inhalation median lethal concentration (4 hr LC50) of the test material was considered to be greater than 10.66 mg/L. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f115b6e-c79b-4283-8013-ab4e27c55e81/documents/IUC5-deebc5f0-17d5-4a41-a6da-c6e8d952da0e_be4e32ac-0357-42bc-a32a-ae780267878d.html,,,,,, "1,1'-(1,1-dimethyl-3-methylene-1,3-propanediyl)bisbenzene",6362-80-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f115b6e-c79b-4283-8013-ab4e27c55e81/documents/IUC5-deebc5f0-17d5-4a41-a6da-c6e8d952da0e_be4e32ac-0357-42bc-a32a-ae780267878d.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "1,1'-(1,1-dimethyl-3-methylene-1,3-propanediyl)bisbenzene",6362-80-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f115b6e-c79b-4283-8013-ab4e27c55e81/documents/IUC5-deebc5f0-17d5-4a41-a6da-c6e8d952da0e_be4e32ac-0357-42bc-a32a-ae780267878d.html,,inhalation,LC50,"10,660 mg/m3",no adverse effect observed, "1,1'-(1,3-phenylene)bis-1H-pyrrole-2,5-dione",3006-93-7," Subacute (rat, 42/52 days): NOAEL for both sexes was 15 mg/kg bw/day and the NOEL was <15 mg/kg bw/day (OECD 422/GLP) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5805c364-6900-4e11-a13b-af23c1a0f557/documents/af145a2c-6d4c-4a80-a17a-824aa29383e7_81b893ef-2b87-417a-927b-fc47f3212cdd.html,,,,,, "1,1'-(1,3-phenylene)bis-1H-pyrrole-2,5-dione",3006-93-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5805c364-6900-4e11-a13b-af23c1a0f557/documents/af145a2c-6d4c-4a80-a17a-824aa29383e7_81b893ef-2b87-417a-927b-fc47f3212cdd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "1,1'-(1,3-phenylene)bis-1H-pyrrole-2,5-dione",3006-93-7, Acute Oral Toxicity: LD50 (male/female) >300-2000 mg/kg bw (OECD 423/GLP) Acute Inhalational Toxicity (OECD 403): LC50 Males =    0.055 mg/l (0.015 mg/l - 0.332 mg/l) LC50 Females =    0.136 mg/l LC50 Combined =    0.089 mg/l (0.044 mg/l - 0.256 mg/l) Acute Dermal Toxicity: Waived ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5805c364-6900-4e11-a13b-af23c1a0f557/documents/c8990423-6940-43d8-a667-d098a486e9cf_81b893ef-2b87-417a-927b-fc47f3212cdd.html,,,,,, "1,1'-(1,3-phenylene)bis-1H-pyrrole-2,5-dione",3006-93-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5805c364-6900-4e11-a13b-af23c1a0f557/documents/c8990423-6940-43d8-a667-d098a486e9cf_81b893ef-2b87-417a-927b-fc47f3212cdd.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "1,1'-(1,3-phenylene)bis-1H-pyrrole-2,5-dione",3006-93-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5805c364-6900-4e11-a13b-af23c1a0f557/documents/c8990423-6940-43d8-a667-d098a486e9cf_81b893ef-2b87-417a-927b-fc47f3212cdd.html,,inhalation,LC50,0.089 mg/m3,adverse effect observed, "1,1'-(1,3-Phenylenedicarbonyl)diazepan-2-one",7381-13-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37060e02-1acd-4fe8-9832-89d64b907116/documents/IUC5-58b4db46-81d6-4688-b777-854a891fb562_8f9d8a2c-d734-46cc-9c6e-ea76bf3fb7fd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,1'-(1,3-Phenylenedicarbonyl)diazepan-2-one",7381-13-7,LD50 (oral) >2000 mg/kg b.w. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37060e02-1acd-4fe8-9832-89d64b907116/documents/IUC5-89339b69-a9d3-4289-8cdd-51445e253347_8f9d8a2c-d734-46cc-9c6e-ea76bf3fb7fd.html,,,,,, "1,1'-(1,3-Phenylenedicarbonyl)diazepan-2-one",7381-13-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37060e02-1acd-4fe8-9832-89d64b907116/documents/IUC5-89339b69-a9d3-4289-8cdd-51445e253347_8f9d8a2c-d734-46cc-9c6e-ea76bf3fb7fd.html,,oral,LD50,"2,000 mg/kg bw",, "4,4'-(1-phenylethane-1,1-diyl)bis(heptyloxybenzene)",1799707-26-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Sufficient to address requirements. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/09cbbeac-de5e-4d61-a0d5-02ed1d25ebf0/documents/0f2567ff-bd6a-4b96-afc5-03654978c521_723a0c83-866f-4090-abab-392c7fdd21eb.html,,,,,, "4,4'-(1-phenylethane-1,1-diyl)bis(heptyloxybenzene)",1799707-26-8,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/09cbbeac-de5e-4d61-a0d5-02ed1d25ebf0/documents/0f2567ff-bd6a-4b96-afc5-03654978c521_723a0c83-866f-4090-abab-392c7fdd21eb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "4,4'-(1-phenylethane-1,1-diyl)bis(heptyloxybenzene)",1799707-26-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Sufficient to address requirements. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Sufficient to meet requirement. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Sufficient to meet requirement. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09cbbeac-de5e-4d61-a0d5-02ed1d25ebf0/documents/792b53e3-1a50-4abe-9b2e-710c75c17ec4_723a0c83-866f-4090-abab-392c7fdd21eb.html,,,,,, "4,4'-(1-phenylethane-1,1-diyl)bis(heptyloxybenzene)",1799707-26-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09cbbeac-de5e-4d61-a0d5-02ed1d25ebf0/documents/792b53e3-1a50-4abe-9b2e-710c75c17ec4_723a0c83-866f-4090-abab-392c7fdd21eb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-(1-phenylethane-1,1-diyl)bis(heptyloxybenzene)",1799707-26-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09cbbeac-de5e-4d61-a0d5-02ed1d25ebf0/documents/792b53e3-1a50-4abe-9b2e-710c75c17ec4_723a0c83-866f-4090-abab-392c7fdd21eb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1'-(4-chlorobutylidene)bis[4-fluorobenzene]",3312-04-7, LD50 was estimated to be 10780mg/kg bw when rats were orally exposed with 1-[4-chloro-1-(4-fluorophenyl) butyl]-4-fluorobenzene. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac40235f-c581-4570-96bb-06ef541bdb1f/documents/908c9210-614f-4d45-9278-38d03f7b7856_9b04737d-17f4-47bf-b56e-35633e692158.html,,,,,, "1,1'-(4-chlorobutylidene)bis[4-fluorobenzene]",3312-04-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac40235f-c581-4570-96bb-06ef541bdb1f/documents/908c9210-614f-4d45-9278-38d03f7b7856_9b04737d-17f4-47bf-b56e-35633e692158.html,,oral,LD50,"10,780 mg/kg bw",no adverse effect observed, "1,1'-(4-methyl-1,3-phenylene)bis-1H-pyrrole-2,5-dione",6422-83-9," - Oral NOAEL(28 d, rat, m/f) = 100 mg/kg bw/day; OECD 407, RL 1; GLP - Oral NOAEL (7 d, rat, m/f) = 100 mg/kg bw/day; dose range finding study, non-GLP ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a0f52d9-4e33-4e5e-b234-e3f143d968e1/documents/b999a87f-2e09-4b1a-8f69-ad5aa6c83725_d0cf1bcd-5a2d-4030-96e6-c3a170314674.html,,,,,, "1,1'-(4-methyl-1,3-phenylene)bis-1H-pyrrole-2,5-dione",6422-83-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a0f52d9-4e33-4e5e-b234-e3f143d968e1/documents/b999a87f-2e09-4b1a-8f69-ad5aa6c83725_d0cf1bcd-5a2d-4030-96e6-c3a170314674.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1,1'-(4-methyl-1,3-phenylene)bis-1H-pyrrole-2,5-dione",6422-83-9," - Acute oral toxicity: LD50(rat, m/f) > 2000 mg/kg bw; OECD TG 401; RL1; GLP - Acute inhalation toxicity: LC50(rat, m/f) = 0.09 mg/L; OECD TG 403; RL1; GLP - Acute dermal toxicity: LD50(rat, m/f) > 2000 mg/kg bw; OECD TG 402; RL1; GLP ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a0f52d9-4e33-4e5e-b234-e3f143d968e1/documents/8aa39e9b-1728-434c-8b4d-5ef275cb27bd_d0cf1bcd-5a2d-4030-96e6-c3a170314674.html,,,,,, "1,1'-(4-methyl-1,3-phenylene)bis-1H-pyrrole-2,5-dione",6422-83-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a0f52d9-4e33-4e5e-b234-e3f143d968e1/documents/8aa39e9b-1728-434c-8b4d-5ef275cb27bd_d0cf1bcd-5a2d-4030-96e6-c3a170314674.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,1'-(4-methyl-1,3-phenylene)bis-1H-pyrrole-2,5-dione",6422-83-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a0f52d9-4e33-4e5e-b234-e3f143d968e1/documents/8aa39e9b-1728-434c-8b4d-5ef275cb27bd_d0cf1bcd-5a2d-4030-96e6-c3a170314674.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,1'-(4-methyl-1,3-phenylene)bis-1H-pyrrole-2,5-dione",6422-83-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a0f52d9-4e33-4e5e-b234-e3f143d968e1/documents/8aa39e9b-1728-434c-8b4d-5ef275cb27bd_d0cf1bcd-5a2d-4030-96e6-c3a170314674.html,,inhalation,LC50,90 mg/m3,adverse effect observed, "1,1'-(benzene-1,3-diyldimethanediyl)bis(1H-pyrrole-2,5-dione)",13676-53-4," LD50 (experimental) >2000 mg/kg bw (LD50 cut-off = 5000 mg/kg bw), study conducted according to OECD 423, GLP ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d84c4a2-f4c0-4192-a822-5a4208f13d8b/documents/7a00e688-0e16-4777-b46c-3552d9dd6b72_1adaad1f-6faa-438c-acd9-d874d425daa1.html,,,,,, "1,1'-(benzene-1,3-diyldimethanediyl)bis(1H-pyrrole-2,5-dione)",13676-53-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d84c4a2-f4c0-4192-a822-5a4208f13d8b/documents/7a00e688-0e16-4777-b46c-3552d9dd6b72_1adaad1f-6faa-438c-acd9-d874d425daa1.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,1'-(chlorophenylmethylene)bis[4-methoxybenzene]",40615-36-9," No information on the acute toxicity for 4,4’-Dimethoxytrityl chloride (target substance) is publicly available. In accordance with REACH Regulation (EC) No 1907/2006, Annex VII, column 2 of section 8.5, no acute oral toxicity study need to be conducted as the test item is classified as corrosive to the skin (Cat. 1B, H314). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99f55553-13cc-4e34-a133-7a2bec37c4f9/documents/91291d7d-a047-412f-a201-415104fce55c_e68687a2-249d-4e9d-acd1-822a89529c69.html,,,,,, "1,1'-(ethane-1,2-diyl)bis[pentabromobenzene]",84852-53-9,Guideline- and GLP-compliant 28- and 90-d studies in rats. Results published in the peer-reviewed literature. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/578c0ca4-2d04-4f31-99bb-149c3ae9578a/documents/IUC5-bfa6b17e-2f67-4375-9108-9e45de803485_42fdde49-52c6-4b38-b2fa-934508de00d1.html,,,,,, "1,1'-(ethane-1,2-diyl)bis[pentabromobenzene]",84852-53-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/578c0ca4-2d04-4f31-99bb-149c3ae9578a/documents/IUC5-bfa6b17e-2f67-4375-9108-9e45de803485_42fdde49-52c6-4b38-b2fa-934508de00d1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,1'-(ethane-1,2-diyl)bis[pentabromobenzene]",84852-53-9,Guideline- and GLP-compliant acute rat oral and rabbit dermal studies. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/578c0ca4-2d04-4f31-99bb-149c3ae9578a/documents/IUC5-12bc9e66-c248-4cd1-8b39-b2c6e4bf4263_42fdde49-52c6-4b38-b2fa-934508de00d1.html,,,,,, "1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]",97416-84-7,Repeated dose oral toxicity: NOEL = 100 mg/kg bw ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c595b728-012f-4cd7-ace5-a1a0b7979476/documents/IUC5-260f3c24-2c5f-46a1-932d-523b55933d66_ab7f504a-52d3-47bb-9e58-3f23e34d28bb.html,,,,,, "1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]",97416-84-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c595b728-012f-4cd7-ace5-a1a0b7979476/documents/IUC5-260f3c24-2c5f-46a1-932d-523b55933d66_ab7f504a-52d3-47bb-9e58-3f23e34d28bb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,mouse "1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]",97416-84-7,LD50 (oral) > 2000 mg/kg bwLC50(inhalation) > 87000 mg/m3LD50(dermal) > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c595b728-012f-4cd7-ace5-a1a0b7979476/documents/IUC5-8313407e-806f-4718-929b-4eed9801c7e6_ab7f504a-52d3-47bb-9e58-3f23e34d28bb.html,,,,,, "1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]",97416-84-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c595b728-012f-4cd7-ace5-a1a0b7979476/documents/IUC5-8313407e-806f-4718-929b-4eed9801c7e6_ab7f504a-52d3-47bb-9e58-3f23e34d28bb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]",97416-84-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c595b728-012f-4cd7-ace5-a1a0b7979476/documents/IUC5-8313407e-806f-4718-929b-4eed9801c7e6_ab7f504a-52d3-47bb-9e58-3f23e34d28bb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromo-2-methylpropoxy)benzene]",97416-84-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c595b728-012f-4cd7-ace5-a1a0b7979476/documents/IUC5-8313407e-806f-4718-929b-4eed9801c7e6_ab7f504a-52d3-47bb-9e58-3f23e34d28bb.html,,inhalation,LC50,"87,000 mg/m3",no adverse effect observed, "1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromopropoxy)benzene]",21850-44-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3497eb16-a2ee-4e49-aaa9-bfe693b080ec/documents/IUC5-623c7be7-9a1c-48f7-8249-c788376a831f_51432e4e-30f0-43c4-948c-be3b7b5a9608.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,000 mg/kg bw/day",,mouse "1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromopropoxy)benzene]",21850-44-2,Acute oral: LD50 > 2000 mg/kgAcute inhalation: LC50> 24.4 mg/L (air)Acute dermal: LD50 > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3497eb16-a2ee-4e49-aaa9-bfe693b080ec/documents/IUC5-daf69550-079b-4680-ac55-4de6ee15bc7c_51432e4e-30f0-43c4-948c-be3b7b5a9608.html,,,,,, "1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromopropoxy)benzene]",21850-44-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3497eb16-a2ee-4e49-aaa9-bfe693b080ec/documents/IUC5-daf69550-079b-4680-ac55-4de6ee15bc7c_51432e4e-30f0-43c4-948c-be3b7b5a9608.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromopropoxy)benzene]",21850-44-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3497eb16-a2ee-4e49-aaa9-bfe693b080ec/documents/IUC5-daf69550-079b-4680-ac55-4de6ee15bc7c_51432e4e-30f0-43c4-948c-be3b7b5a9608.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1'-(isopropylidene)bis[3,5-dibromo-4-(2,3-dibromopropoxy)benzene]",21850-44-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3497eb16-a2ee-4e49-aaa9-bfe693b080ec/documents/IUC5-daf69550-079b-4680-ac55-4de6ee15bc7c_51432e4e-30f0-43c4-948c-be3b7b5a9608.html,,inhalation,LC50,24.4 mg/m3,no adverse effect observed, "1,1'-(methylenedi-p-phenylene)bismaleimide",13676-54-5," A preliminary 7-day repeat oral dose study was carried out in accordance with GLP (Huntingdon Life Sciences, 2012) in order to select a suitable high dose for a subsequent study. Groups of rats were dosed at 100, 300 or 1000 mg/kg/day. There was no treatment related toxicity, therefore the limit dose level of 1000 mg/kg/day was considered acceptable for use as the notional limit high dose in the subsequent screening study. A combined repeat oral dose/reproductive toxicity study was carried out in accordance with GLP and to international guidelines (Huntingdon Life Sciences, 2012, study LBA0061). Groups were dosed at 100, 300 or 1000 mg/kg/day. No significant adverse effects were observed, therefore the NOAEL was considered to be 1000 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d5047b67-621c-47ab-8178-92632eb85e8b/documents/bc1d097a-75b9-40cb-8286-484fec38edd7_5866a004-a570-4530-bd2d-e170c2e7437f.html,,,,,, "1,1'-(methylenedi-p-phenylene)bismaleimide",13676-54-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d5047b67-621c-47ab-8178-92632eb85e8b/documents/bc1d097a-75b9-40cb-8286-484fec38edd7_5866a004-a570-4530-bd2d-e170c2e7437f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,1'-(methylenedi-p-phenylene)bismaleimide",13676-54-5, The substance BMI is non-toxic via oral route but toxic by inhalation. The oral LD50 in rats is >2000 mg/kg/body weight. The inhalation LC50 in rats is >0.515 <1 mg/L air (4 hr exposure). No test data regarding dermal exposure are available. Testing of dermal exposure was waived as scientifically unjustified due to the availability of the oral  and inhalation data and the fact that BMI is a skin sensitiser. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5047b67-621c-47ab-8178-92632eb85e8b/documents/4264292f-dbd6-4454-a46e-266256bba5dd_5866a004-a570-4530-bd2d-e170c2e7437f.html,,,,,, "1,1'-(methylimino)dipropan-2-ol",4402-30-6,"There are repeated dose studies with a structural analogue of N-Methyldiisopropanolamine, tris-(2-hydroxypropyl)-amine available: In a sub-chronic oral toxicity study in dogs, performed according to FDA guidelines, NOAELs of 272 mg/kg bw/day for males and 288 mg/kg bw/day for females were established, the highest doses tested.In a sub-acute dermal toxicity study in rats, performed according to OECD TG 410, a NOAEL of 3000 mg/kg bw/day (the highest dose tested) for systemic toxicity was established. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef921123-5190-40ea-8d9f-4eaac0772a4d/documents/IUC5-52f1cb94-fe65-47f1-a55d-7e8e8146de45_17b991e3-b9fc-416f-8c5d-1bb062470331.html,,,,,, "1,1'-(methylimino)dipropan-2-ol",4402-30-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef921123-5190-40ea-8d9f-4eaac0772a4d/documents/IUC5-52f1cb94-fe65-47f1-a55d-7e8e8146de45_17b991e3-b9fc-416f-8c5d-1bb062470331.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"3,000 mg/kg bw/day",,rat "1,1'-(methylimino)dipropan-2-ol",4402-30-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef921123-5190-40ea-8d9f-4eaac0772a4d/documents/IUC5-52f1cb94-fe65-47f1-a55d-7e8e8146de45_17b991e3-b9fc-416f-8c5d-1bb062470331.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,272 mg/kg bw/day,,dog "1,1'-(methylimino)dipropan-2-ol",4402-30-6,Acute toxicity data indicate a low toxicity: in rats the oral LD50 was 2150-3830 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef921123-5190-40ea-8d9f-4eaac0772a4d/documents/IUC5-ff90fff9-b913-4687-955a-a46869c7ee46_17b991e3-b9fc-416f-8c5d-1bb062470331.html,,,,,, "1,1'-(methylimino)dipropan-2-ol",4402-30-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef921123-5190-40ea-8d9f-4eaac0772a4d/documents/IUC5-ff90fff9-b913-4687-955a-a46869c7ee46_17b991e3-b9fc-416f-8c5d-1bb062470331.html,,oral,LD50,"2,150 mg/kg bw",no adverse effect observed, "1,1'-(p-tolylimino)dipropan-2-ol",38668-48-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline study ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7bc03a71-b766-4e23-9719-46f5e960fd09/documents/IUC5-0e4adc6e-45e2-4bd9-ab19-e657d81d6b01_f89bb93f-e9cd-480e-858a-58bf408b77ea.html,,,,,, "1,1'-(p-tolylimino)dipropan-2-ol",38668-48-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7bc03a71-b766-4e23-9719-46f5e960fd09/documents/IUC5-0e4adc6e-45e2-4bd9-ab19-e657d81d6b01_f89bb93f-e9cd-480e-858a-58bf408b77ea.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "1,1'-(p-tolylimino)dipropan-2-ol",38668-48-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The oral LD50 is greater than 25 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bc03a71-b766-4e23-9719-46f5e960fd09/documents/IUC5-95f713c5-4404-4ea1-b95f-b4280ba0ba69_f89bb93f-e9cd-480e-858a-58bf408b77ea.html,,,,,, "1,1'-(p-tolylimino)dipropan-2-ol",38668-48-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bc03a71-b766-4e23-9719-46f5e960fd09/documents/IUC5-95f713c5-4404-4ea1-b95f-b4280ba0ba69_f89bb93f-e9cd-480e-858a-58bf408b77ea.html,,oral,LD50,25 mg/kg bw,adverse effect observed, "1,1'-(p-tolylimino)dipropan-2-ol",38668-48-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bc03a71-b766-4e23-9719-46f5e960fd09/documents/IUC5-95f713c5-4404-4ea1-b95f-b4280ba0ba69_f89bb93f-e9cd-480e-858a-58bf408b77ea.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1,1""((methylsilanetriyl)tris)(oxy))tris(2-methylpropan-2-amine)",28911-48-0," Based on all the observations and results from read across studies and applying weight of evidence, it was concluded that the No Observed Adverse Effect Level (NOAEL) for the test chemical is considered to be 1000 mg / kg body weight when Wistar male and female rats were orally treated with test chemical. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35de8fdd-8aef-4e1f-bcae-7d9e25d79618/documents/f65caf6a-77d1-4b7f-8494-fce8e2492303_5fd0c900-e0b4-452d-be91-1501882e2bdf.html,,,,,, "1,1,1""((methylsilanetriyl)tris)(oxy))tris(2-methylpropan-2-amine)",28911-48-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35de8fdd-8aef-4e1f-bcae-7d9e25d79618/documents/f65caf6a-77d1-4b7f-8494-fce8e2492303_5fd0c900-e0b4-452d-be91-1501882e2bdf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,1,1""((methylsilanetriyl)tris)(oxy))tris(2-methylpropan-2-amine)",28911-48-0," On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism, the study does not nedd to be conducted because the substance is classified as corrosive to the skin. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35de8fdd-8aef-4e1f-bcae-7d9e25d79618/documents/0da00dae-cb34-47d5-a0ee-e92766894a92_5fd0c900-e0b4-452d-be91-1501882e2bdf.html,,,,,, "1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-8-iodooctane",2043-57-4,"One study (reliability 2) on acute oral toxicity with the test item 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-8-iodooctane (purity 97%) is taken for evaluation. Existing data from an acute oral toxicity study (reliability of 2) with the surrogate substance 2-Perfluoralkylethyljodide (CAS no. 85995-91-1) are taken as supportive data for the evaluation because the main compound of this substance is the 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-8-iodooctane with about 42 % . The remaining 60 % are fluorocarbon chains of different chain-length. Due to workplace safety aspects the read across to this substance was chosen to demonstrate that there is a similar toxicological behavior in the acute oral toxicity of both substances and to demonstrate the low potential of irritany of this substance class.In order to determine the acute inhalation potential of the test item 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-8-iodooctane (purity 97%) an acute inhalation toxicity study (reliability of 2) was available for evaluation. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebe7f91b-7e6b-4fde-a2e8-a3b85b165a75/documents/IUC5-9271e3ab-22a9-4a5c-b479-beb74b25e486_69e8d717-2e18-45cc-a54a-dfb25d207d00.html,,,,,, "1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-8-iodooctane",2043-57-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebe7f91b-7e6b-4fde-a2e8-a3b85b165a75/documents/IUC5-9271e3ab-22a9-4a5c-b479-beb74b25e486_69e8d717-2e18-45cc-a54a-dfb25d207d00.html,,oral,LD50,"3,868 mg/kg bw",adverse effect observed, "1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluoro-8-iodooctane",2043-57-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebe7f91b-7e6b-4fde-a2e8-a3b85b165a75/documents/IUC5-9271e3ab-22a9-4a5c-b479-beb74b25e486_69e8d717-2e18-45cc-a54a-dfb25d207d00.html,,inhalation,LC50,"10,600 mg/m3",no adverse effect observed, "1,1,1,2,2,3,3-heptafluoro-3-[(trifluorovinyl)oxy]propane",1623-05-8, Two repeat dose studies were conducted with PPVE. The results of the studies were:   The No Observed Adverse Effect Concentration (NOAEC) is 43.89 mg/L (4034 ppm) when tested according to OECD 422 (2016).   The No Observed Adverse Effect Concentration (NOAEC) is 54.4 mg/L (5000 ppm) when tested according a custom protocol. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51c6cf31-80b3-4d2a-9211-fc8522716f64/documents/dcd1c8c6-1188-4a0e-a67a-4bb8dc88fe4b_c3eccbbb-ef8c-4c50-aab4-36437bf8125c.html,,,,,, "1,1,1,2,2,3,3-heptafluoro-3-[(trifluorovinyl)oxy]propane",1623-05-8," Two acute oral, two acute dermal and two acute inhalation toxicity studies were conducted on PPVE. The result of the studies were:   The rat oral LD50 is greater than 2,000 mg/kg when tested according to OECD 401 (1987).   The rat oral LD50 is 13,267 mg/kg when tested in a method similar to OECD 401.   The rat dermal LD50 is greater than 2,000 mg/kg when tested according to OECD 402 (1987).   The rat dermal LD50 could not be determined due to methodological deficiencies in the study design when tested according to a custom protocol.   The rat inhalation LC50 is greater than 58.7 mg/L when tested according to OECD 403.   That rat inhalation LC50 was not determined due to variability in results. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51c6cf31-80b3-4d2a-9211-fc8522716f64/documents/7db8225c-cff3-4a76-a247-a5efb8223089_c3eccbbb-ef8c-4c50-aab4-36437bf8125c.html,,,,,, "1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-(trifluoromethyl)pentane",132182-92-4,Repeat-dose oral and inhalation studies have been conducted on HFE-7300. The results of the studies are: A 28 day oral gavage study resulted in a NOAEL of 150 mg/kg/day.A 10 day inhalation study resulted in a NOAEL of 143 mg/L.A 5 day inhalation study resulted in a NOAEL of 143 mg/L. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb32faf0-6427-4dee-b49b-c3c57afb112d/documents/IUC5-5fb8a259-04c8-432d-af4f-094046575ac1_a180bf7c-cc58-4fc4-a56d-69e2bc5f41ba.html,,,,,, "1,1,1,2,2,3,4,5,5,5-decafluoro-3-methoxy-4-(trifluoromethyl)pentane",132182-92-4,"Acute oral, inhalation, and dermal toxicity studies have been conducted on HFE-7300. The results of the studies are: Acute oral toxicity is greater than 2000 mg/kg body weight in rats when tested according to OECD 423. Acute inhalation toxicity is greater than 428 mg/L, vapor, in rats when tested according to a custom protocol.Acute dermal toxicity is greater than 2000 mg/kg body weight in rats when tested according to OECD 404. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb32faf0-6427-4dee-b49b-c3c57afb112d/documents/IUC5-2b1752db-246b-4c55-8407-78a1d11e7b82_a180bf7c-cc58-4fc4-a56d-69e2bc5f41ba.html,,,,,, "1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluoromethyl )-3-pentanone",756-13-8," Subacute NOAEL (rat, male/female): 12.45 mg/L (OECD 412/GLP) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0d11f7f-85fe-43e0-96ef-064fefc9df88/documents/df156500-d562-42e4-9877-6244ae308543_fbc6d588-9c28-409d-96f0-b553997f7bdc.html,,,,,, "1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluoromethyl )-3-pentanone",756-13-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0d11f7f-85fe-43e0-96ef-064fefc9df88/documents/df156500-d562-42e4-9877-6244ae308543_fbc6d588-9c28-409d-96f0-b553997f7bdc.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"12,450 mg/m3",,rat "1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluoromethyl )-3-pentanone",756-13-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0d11f7f-85fe-43e0-96ef-064fefc9df88/documents/df156500-d562-42e4-9877-6244ae308543_fbc6d588-9c28-409d-96f0-b553997f7bdc.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"12,450 mg/m3",adverse effect observed,rat "1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluoromethyl )-3-pentanone",756-13-8," Acute oral toxicity LD50 (male/female): >2000 mg/kg bw (OECD 423, GLP) Acute dermal toxicity LD50 (male.female): >2000 mg/kg bw (OECD 402, GLP) Acute inhalation toxicity LC50 (male/female): >1275 mg/L air (OECD 403, GLP) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0d11f7f-85fe-43e0-96ef-064fefc9df88/documents/184323a8-057a-418c-a3de-61fd7050e90d_fbc6d588-9c28-409d-96f0-b553997f7bdc.html,,,,,, "1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluoromethyl )-3-pentanone",756-13-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0d11f7f-85fe-43e0-96ef-064fefc9df88/documents/184323a8-057a-418c-a3de-61fd7050e90d_fbc6d588-9c28-409d-96f0-b553997f7bdc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluoromethyl )-3-pentanone",756-13-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0d11f7f-85fe-43e0-96ef-064fefc9df88/documents/184323a8-057a-418c-a3de-61fd7050e90d_fbc6d588-9c28-409d-96f0-b553997f7bdc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1,1,2,2,4,5,5,5-nonafluoro-4-(trifluoromethyl )-3-pentanone",756-13-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0d11f7f-85fe-43e0-96ef-064fefc9df88/documents/184323a8-057a-418c-a3de-61fd7050e90d_fbc6d588-9c28-409d-96f0-b553997f7bdc.html,,inhalation,LC50,"1,275,000 mg/m3",no adverse effect observed, "1,1,1,3,3,3-hexafluoro-2-methoxypropane",13171-18-1," In a GLP guideline study conducted according to US EPA OPPTS 870.1100 (2002) to assess the acute oral toxicity with 3 female Sprague-Dawley young adult rats, no mortalities were observed at the limit dose of 5000 mg/kg-bw. All animals were healthy and active throughout the study and 14 -day observation period and there were no gross abnormalities observed at necropsy. Therefore, the Oral LD50 is >5000 mg/kg-bw. In a GLP guideline study conducted according to OECD Method 403 (2009) to assess the acute inhalation toxicity with 5 male and 5 female Sprague-Dawley young adult rats, no mortalities were observed at either 7322 ppm or 24685 ppm for 4 -hours. All animals exhibited irregular respiration immediately following exposrue but recovered by day 1 and were healthy and active throughout the remainder of the 14 -day observation period. There were no gross abnormalities observed at necropsy. Therefore, the 4 -hour LC50 is >24685 ppm (183.82 mg/L). In a GLP guideline study conducted according to US EPA OPPTS 870.1200 (1998) to assess the acute dermal toxicity with 5 male and 5 female Sprague-Dawley young adult rats, no mortalities were observed at the limit dose of 5000 mg/kg-bw. All animals were healthy and active throughout the study and 14 -day observation period and there were no gross abnormalities observed at necropsy. Therefore, the Dermal LD50 is >5000 mg/kg-bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bdef84d-5c67-4366-9b95-9895b0baf835/documents/cfdbdd01-7dd6-4a89-8e77-10be831348a7_5992068c-84f0-44f3-b9a6-595e049470e6.html,,,,,, "1,1,1,3,3,3-hexamethyldisilazane",999-97-3," In a 90-day repeated dose toxicity study conducted according to OECD Test Guidelines 413 and in compliance with GLP, nose-only inhalation exposure of 1,1,1,3,3,3-hexamethyldisilazane (CAS 999-97-3, EC 213-668-5) at concentrations of 25, 75 or 400 ppm to Sprague-Dawley rats for 6 hours per day, 5 days per week for 13 weeks resulted in minor and reversible changes at the highest concentration. Renal effects in male rats were observed at all concentrations, but these findings were consistent with alpha-2u-nephropathy and therefore of no toxicological significance to humans. Based on the results in this study, the NOAEC was considered to be higher than or equal to 400 ppm (equivalent to 2640 mg/m3), the highest concentration tested (Harlan 2014). 1,1,1,3,3,3-Hexamethyldisilazane is rapidly hydrolysed in contact with moisture releasing trimethylsilanol and ammonia. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82916ea7-5cd2-4812-b141-d02922fdfe14/documents/58ab7f95-9bfe-402c-bc35-c7bfe95ac1c6_fd4408ca-1044-4860-9ea4-7ce580a9899d.html,,,,,, "1,1,1,3,3,3-hexamethyldisilazane",999-97-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82916ea7-5cd2-4812-b141-d02922fdfe14/documents/58ab7f95-9bfe-402c-bc35-c7bfe95ac1c6_fd4408ca-1044-4860-9ea4-7ce580a9899d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"2,640 mg/m3",,rat "1,1,1,3,3,3-hexamethyldisilazane",999-97-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82916ea7-5cd2-4812-b141-d02922fdfe14/documents/58ab7f95-9bfe-402c-bc35-c7bfe95ac1c6_fd4408ca-1044-4860-9ea4-7ce580a9899d.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"2,640 mg/m3",no adverse effect observed,rat "1,1,1,3,3,3-hexamethyldisilazane",999-97-3," In an acute oral toxicity study with 1,1,1,3,3,3-hexamethyldisilazane (CAS 999-97-3, EC 213-668-5), conducted according to a protocol comparable to the now-deleted OECD Test Guideline 401 but without information on GLP compliance, the LD50 was concluded to be 1.1 ml/kg bw/day (equivalent to 847 mg/kg bw based on a density of 0.77 g/cm³) (Bayer, 1988). In an acute inhalation toxicity study conducted according to OECD Test Guideline 403 and in compliance with GLP, the LC50 value for 1,1,1,3,3,3-hexamethyldisilazane in the Sprague-Dawley rat was determined to be 1516 ppm (equivalent to 10000 mg/m³) (Dow Corning Corporation, 2007). In an acute dermal toxicity study conducted according to a protocol similar to OECD Test Guideline 402, but without information on GLP compliance, the LD50 for 1,1,1,3,3,3-hexamethyldisilazane was concluded to be 544 mg/kg bw in females and 585 mg/kg bw in males (based on a density of 0.77 g/cm³) (Bushy Run Research Centre, 1981). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82916ea7-5cd2-4812-b141-d02922fdfe14/documents/97c05719-6d30-41e3-8c85-27e5dbe32b2c_fd4408ca-1044-4860-9ea4-7ce580a9899d.html,,,,,, "1,1,1,3,3,3-hexamethyldisilazane",999-97-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82916ea7-5cd2-4812-b141-d02922fdfe14/documents/97c05719-6d30-41e3-8c85-27e5dbe32b2c_fd4408ca-1044-4860-9ea4-7ce580a9899d.html,,oral,LD50,847 mg/kg bw,adverse effect observed, "1,1,1,3,3,3-hexamethyldisilazane",999-97-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82916ea7-5cd2-4812-b141-d02922fdfe14/documents/97c05719-6d30-41e3-8c85-27e5dbe32b2c_fd4408ca-1044-4860-9ea4-7ce580a9899d.html,,dermal,LD50,544 mg/kg bw,adverse effect observed, "1,1,1,3,3,3-hexamethyldisilazane",999-97-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82916ea7-5cd2-4812-b141-d02922fdfe14/documents/97c05719-6d30-41e3-8c85-27e5dbe32b2c_fd4408ca-1044-4860-9ea4-7ce580a9899d.html,,inhalation,LC50,"10,000 mg/m3",adverse effect observed, "1,1,1,3,5,5,5-heptamethyltrisiloxane",1873-88-7,"In an oral repeated dose toxicity study (combined with a reproduction/developmental toxicity screening test), performed to GLP and conducted according to OECD Guideline 422, a NOAEL of 50 mg/kg bw/day was reported in rats treated with H-L3 (Harlan Laboratories Ltd., 2010a, reliability 1). Effects observed at 200 mg/kg bw/day were considered by the authors of this CSR to be either adaptive and non-adverse, or specific to male rats and therefore not relevant for human hazard assessment. The overall NOAEL relevant for humans was 200 mg/kg bw/day. Read-across inhalation data are available for the related substance octamethyltrisiloxane (L3, CAS 107-51-7). Whole body exposure of Sprague Dawley rats for 90 days resulted in liver and kidney changes (Harlan Laboratories Ltd., 2011, reliability 1). In the liver hepatocyte hypertrophy and accumulation of hepatic brown pigment in the bile ducts with associated periportal inflammation and bile duct proliferation were noted. In the kidneys tubular hypertrophy was noted and associated with minor changes in salt balance and plasma protein levels. Hyaline droplets noted represented alpha-2u-globulin accumulation. Based on the pigment accumulation noted in the liver at 3200 ppm the NOAEC (inhalation) was considered to be 400 ppm (3870 mg/m3). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a71076e0-32e3-4638-9d0b-487d127df85b/documents/44982980-bf7a-4259-98dd-abef08bca588_67e9d0aa-0d7c-48b6-854f-3c27c8067b28.html,,,,,, "1,1,1,3,5,5,5-heptamethyltrisiloxane",1873-88-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a71076e0-32e3-4638-9d0b-487d127df85b/documents/44982980-bf7a-4259-98dd-abef08bca588_67e9d0aa-0d7c-48b6-854f-3c27c8067b28.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "1,1,1,3,5,5,5-heptamethyltrisiloxane",1873-88-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a71076e0-32e3-4638-9d0b-487d127df85b/documents/44982980-bf7a-4259-98dd-abef08bca588_67e9d0aa-0d7c-48b6-854f-3c27c8067b28.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"3,870 mg/m3",,rat "1,1,1,3,5,5,5-heptamethyltrisiloxane",1873-88-7,"The key study for acute oral toxicity reports an LD50 value greater than 2000 mg/kg bw which was determined in a reliable study with 1,1,1,3,5,5,5-heptamethyltrisiloxane (H-L3), carried out in accordance with OECD Test Guideline 425 and in compliance with GLP (RCC, 2008a, reliability 1).   The key acute inhalation study is read across from octamethyltrisiloxane (L3, CAS 107-51-7). The animals were exposed to vapour and an LC50 value greater than 22.6 mg/l (analytical) was determined in a reliable study conducted according to OECD Test Guideline 403 and in compliance with GLP (Dow Corning Corporation, 2004, reliability 1). In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the dermal route (required in Section 8.5.2) does not need to be conducted as reliable data via the oral and inhalation routes are available. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a71076e0-32e3-4638-9d0b-487d127df85b/documents/ada377db-2305-45a3-9f21-14321a54ba68_67e9d0aa-0d7c-48b6-854f-3c27c8067b28.html,,,,,, "1,1,1,3,5,5,5-heptamethyltrisiloxane",1873-88-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a71076e0-32e3-4638-9d0b-487d127df85b/documents/ada377db-2305-45a3-9f21-14321a54ba68_67e9d0aa-0d7c-48b6-854f-3c27c8067b28.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1,1,3,5,5,5-heptamethyltrisiloxane",1873-88-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a71076e0-32e3-4638-9d0b-487d127df85b/documents/ada377db-2305-45a3-9f21-14321a54ba68_67e9d0aa-0d7c-48b6-854f-3c27c8067b28.html,,inhalation,LC50,"22,600 mg/m3",no adverse effect observed, "1,1,1-trifluoroethane",420-46-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82cc52cd-0ea0-4585-97a4-f39a59d42e69/documents/IUC5-5018a2dd-3e4f-4cb9-a3be-ded4462135f5_aa8f2052-9880-4168-9cc1-02640280e448.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"138,000 mg/m3",, "1,1,1-trifluoroethane",420-46-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82cc52cd-0ea0-4585-97a4-f39a59d42e69/documents/IUC5-3ad4f305-46f5-4cad-8c3a-6307da07a76c_aa8f2052-9880-4168-9cc1-02640280e448.html,,inhalation,,"2,030,000 mg/m3",, "1,1,1-Tris(omega-(2,2-dimethyl-3-lauroyloxy-propylidene-amin o)-poly(oxy(methyl-1,2-ethanediyl))methyl)propane",613246-79-0," In a acute oral toxicity with the test item according to OECD guideline 438 an an oral discriminating dose of 2000 mg/kgbw of Sika Hardener LTJ was estimated.   One additional read across study is available with the hydrolysis product of the test item Aldehyd L. The LD 50 was determined to be >2000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP and Guideline study ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f4c82d5-31e3-4c3d-b33b-e8cd9450df95/documents/df91481b-c989-49fd-be20-0c1efc28a47e_b6a9adda-33fc-4735-818b-7cfa0b2e53f4.html,,,,,, "1,1,1-Tris(omega-(2,2-dimethyl-3-lauroyloxy-propylidene-amin o)-poly(oxy(methyl-1,2-ethanediyl))methyl)propane",613246-79-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f4c82d5-31e3-4c3d-b33b-e8cd9450df95/documents/df91481b-c989-49fd-be20-0c1efc28a47e_b6a9adda-33fc-4735-818b-7cfa0b2e53f4.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,1,2,2,3,3,4,4,4-nonafluoro-N-(2-hydroxyethyl)-N-methylbutane-1-sulphonamide",34454-97-2, Acute oral and dermal toxicity studies have been conducted on C4 alcohol. The results of the studies were: Acute oral toxicity is greater than 2000 mg/kg when tested according to OECD 423. Acute dermal toxicity is greater than 2000 mg/kg when tested according to OECD 402. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fdae06ff-54ac-4f09-a556-36fdbadd3f21/documents/b8945daa-5edd-426d-80c2-6e0ac55510da_1463172e-b0e7-40d6-b962-8580a742158b.html,,,,,, "1,1,2,2,3,3,4,4,4-nonafluoro-N,N-bis(2-hydroxyethyl)butane-1-sulphonamide",34455-00-0," Two acute toxicity studies were conducted on FBSEE diol. The results of the studies were: - The acute oral LD50 is greater than 2,000 mg/kg when tested according to OECD 423 (2001). - The acute dermal LD50 is greater than 2,000 mg/kg when tested according to OECD 402. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8db96a26-12db-4c06-b372-96c9b749877d/documents/fb627083-6e0d-4791-9c5b-af50382305b9_4270193f-87a3-40dd-b285-457cdbbb34a5.html,,,,,, "1,1,2,2,3,3,4,4-octafluoro-1,4-diiodobutane",375-50-8," A non-GLP screening study by the oral route, 2 dose-range finding studies and a 28-day by inhalation were available in rats and provided partial information but did not allow to determine robust NOAE(C)Ls. Based on the subacute dose-range finding studies (5 or 7 days) by inhalation, studies showed decreased body weight at 10 ppm and higher, and increased liver and adrenals weights, with effects that were usually more marked in males and at the highest doses. Microscopic examinations showed signs of hepatocellular hypertrophy. In the 7-d DRF, increased ASAT and ALAT, GGT and SDH in males were observed at 291 ppm, as well as increased TSH in males and females at 50.4 ppm and above, consistent with metabolic adaptation. Slight effects on body weight and organ weights were observed in the 28-day inhalation study at the dose of 2 ppm, but were not associated with any microscopic findings. By the oral route similar effects on body weight, organ weights and swollen liver were observed at the high dose (30 mg/kg/day). No microscopic examination was conducted in this screening study. In addition, a reduced size of testes, epididymides, prostate and seminal vesicles was observed at the high dose. Hormone variations, in particular increased T4 and TSH, were observed especially in the highest dose groups. This was consistent with the inhibition of the 5'-deiodinase activity observed in vitro in rat or human microsomal fractions incubated with diiodoperfluorobutane (reported under specific investigations). The available set of information was not sufficient to determine a classification. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/71478ee4-e410-4ddd-ab03-57641ac4e8a1/documents/97715860-c2ee-4599-8fbf-a1cce628b579_f720d6a6-e489-4cb8-9ef6-1d1e17a8a9f1.html,,,,,, "1,1,2,2,3,3,4,4-octafluoro-1,4-diiodobutane",375-50-8," The registered substance was tested by the oral and inhalation routes. In a single key study, conducted according to EC method B.1 and in compliance with GLP, no mortality was observed at the oral limit dose of 2000 mg/kg bw in males and females. The main clinical signs included reduced activity, and a hunched posture after dosing, then ataxia at 24 hours. By inhalation, in the selected key study conducted according to OECD guideline 403 and EC method B.2, the LC50 was found to be above 23 mg/L (> 0.023 mg/m3 ; > 1238 ppm). No mortality was observed at that dose but animals showed decreased activity until day 5. At the next higher dose (2576 ppm ; 46.31 mg/L) , all animals were comatose following the dosing (first day), then most animals showed transient reduced activity and loss of reflex in the following days. Some animals were sacrificed during the observation period due to severe clinical signs. Another acute inhalation study was not used to determine the LC50 due to some technical deficiencies, however, similar clinical signs were observed, supporting GHS classification for narcotic effects. A single key study, conducted according to OECD 402 and in compliance with GLP, no mortality was observed at the dermal limit dose of 2000 mg/kg bw in males and females. No clinical signs and no local skin reactions were noted during the study. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71478ee4-e410-4ddd-ab03-57641ac4e8a1/documents/dee53ee9-33f5-413a-ae20-d7d8062f0d1b_f720d6a6-e489-4cb8-9ef6-1d1e17a8a9f1.html,,,,,, "1,1,2,2,3,3,4,4-octafluoro-1,4-diiodobutane",375-50-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71478ee4-e410-4ddd-ab03-57641ac4e8a1/documents/dee53ee9-33f5-413a-ae20-d7d8062f0d1b_f720d6a6-e489-4cb8-9ef6-1d1e17a8a9f1.html,,inhalation,discriminating conc.,0.023 mg/m3,adverse effect observed, "1,1,2,2,3,3,4-heptafluorocyclopentane",15290-77-4,"Oral:The 28d test was conducted in compliance with EC B.7.The No-Observed-Adverse-Effect Level (NOAEL) was considered to be 1000 mg/kg/day, and the NOEL for both sexes is considered to be 1000 mg/kg/day. Inhalation:The response of rats to repeated inhalation administration, by snout only exposure to a vapour of the test substance for 13 consecutive weeks were assessed in accordance with OECD 413. No Observed Adverse Effect Level (NOAEL): 367 ppm (2.99 mg/L). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4a58f4d-c7da-4db6-a629-39056936fcb0/documents/d8fcfe96-de3f-429b-8f90-94a7efd28381_9f00726e-3240-45e2-a36f-c6296585bcbe.html,,,,,, "1,1,2,2,3,3,4-heptafluorocyclopentane",15290-77-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4a58f4d-c7da-4db6-a629-39056936fcb0/documents/d8fcfe96-de3f-429b-8f90-94a7efd28381_9f00726e-3240-45e2-a36f-c6296585bcbe.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,1,2,2,3,3,4-heptafluorocyclopentane",15290-77-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4a58f4d-c7da-4db6-a629-39056936fcb0/documents/d8fcfe96-de3f-429b-8f90-94a7efd28381_9f00726e-3240-45e2-a36f-c6296585bcbe.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"2,990 mg/m3",,rat "1,1,2,2,3,3,4-heptafluorocyclopentane",15290-77-4,Oral:This study was performed to assess the acute oral toxicity of test item to the rat based on EC method B.1.The acute lethal oral dose (LC50) to rats of test item was demonstrated to be greater than 2000 mg/kg bodyweight. Inhalation:The acute inhalation toxicity of test item was assessed in compliance with OECD 403. The LC50 (4 hour) for test item is estimated at 14213 ppm (124401.8 mg/m3) in air for males and females combined. Dermal:A study was performed to assess the acute dermal toxicity of test item to the rat following EC B.3. The acute lethal dermal dose (LC50) to rats of test item was demonstrated to be greater than 2000 mg/kg bodyweight. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4a58f4d-c7da-4db6-a629-39056936fcb0/documents/446a60b9-de2d-4742-b770-f2df243ae80f_9f00726e-3240-45e2-a36f-c6296585bcbe.html,,,,,, "1,1,2,2,3,3,4-heptafluorocyclopentane",15290-77-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4a58f4d-c7da-4db6-a629-39056936fcb0/documents/446a60b9-de2d-4742-b770-f2df243ae80f_9f00726e-3240-45e2-a36f-c6296585bcbe.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1,2,2,3,3,4-heptafluorocyclopentane",15290-77-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4a58f4d-c7da-4db6-a629-39056936fcb0/documents/446a60b9-de2d-4742-b770-f2df243ae80f_9f00726e-3240-45e2-a36f-c6296585bcbe.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1,2,2,3,3,4-heptafluorocyclopentane",15290-77-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4a58f4d-c7da-4db6-a629-39056936fcb0/documents/446a60b9-de2d-4742-b770-f2df243ae80f_9f00726e-3240-45e2-a36f-c6296585bcbe.html,,inhalation,LC50,"124,401.8 mg/m3",adverse effect observed, "1,1,2,2-tetrafluoro-2-[(trifluorovinyl)oxy]ethanesulfonyl fluoride",29514-94-1,"LD50 oral, rat > 2000 mg/kg bwLD50 dermal, rat > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c30d2bb5-9187-459e-bf1c-2e1ce5e89588/documents/IUC5-18ac4c8b-e891-4d02-9cbd-317ac4a64245_fca9fa5c-7f80-4786-850a-192530e70c1b.html,,,,,, "1,1,2,2-tetrafluoro-2-[(trifluorovinyl)oxy]ethanesulfonyl fluoride",29514-94-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c30d2bb5-9187-459e-bf1c-2e1ce5e89588/documents/IUC5-18ac4c8b-e891-4d02-9cbd-317ac4a64245_fca9fa5c-7f80-4786-850a-192530e70c1b.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,1,2,2-tetrafluoro-2-[(trifluorovinyl)oxy]ethanesulfonyl fluoride",29514-94-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c30d2bb5-9187-459e-bf1c-2e1ce5e89588/documents/IUC5-18ac4c8b-e891-4d02-9cbd-317ac4a64245_fca9fa5c-7f80-4786-850a-192530e70c1b.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,1,2,3,4,4-hexafluorobuta-1,3-diene",685-63-2," The gaseous substance could only be tested by the inhalation route. The effects obtained in 2 reliable studies were slightly different in intensity, possibly because of the different rat strains tested (a 28-day inhalation study in Sprague-Dawley rats and an OECD421 by inhalation in Wistar rats). Based on effects observed mainly on relative organ weights, the kidneys seem to be the target organ. After 28 days of exposure, the main effects were reduced body weight gain (especially in females at 50 ppm), significant increase in relative / adjusted kidney weights at 15 and 50 ppm (males, females) and 5 ppm (females), significant increase in adjusted liver weights at 15 and 50 ppm (but not observed in Wistar exposed at the same concentrations and for the same duration). These changes were not associated with significant lesions in the kidneys or liver. In Sprague-Dawley, the 28-day exposure was associated with microscopic changes in the nasal turbinates (pseudogland formation) and decreased body weight gain. The local effects on nasal turbinates were not observed in Wistar rats in the OECD421 study indicating differences in susceptibility depending on the rat strain. They were considered to be a minor response. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d38dd81-43d4-4d88-894b-6f44f2a002d3/documents/2bb8f5f8-3c34-45c6-a9c2-ea9ccc10471b_1a861a09-0462-4037-8952-903b55a18dcf.html,,,,,, "1,1,2,3,4,4-hexafluorobuta-1,3-diene",685-63-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d38dd81-43d4-4d88-894b-6f44f2a002d3/documents/2bb8f5f8-3c34-45c6-a9c2-ea9ccc10471b_1a861a09-0462-4037-8952-903b55a18dcf.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,99.4 mg/m3,,rat "1,1,2,3,4,4-hexafluorobuta-1,3-diene",685-63-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d38dd81-43d4-4d88-894b-6f44f2a002d3/documents/2bb8f5f8-3c34-45c6-a9c2-ea9ccc10471b_1a861a09-0462-4037-8952-903b55a18dcf.html,Repeated dose toxicity – local effects,inhalation,NOAEC,99.4 mg/m3,adverse effect observed,rat "1,1,2,3,4,4-hexafluorobuta-1,3-diene",685-63-2," As 1,1,2,3,4,4-hexafluorobuta-1,3-diene is a gaseous substance at ambient temperature, only the inhalation route could be evaluated. Dose-dependent acute toxicity effects and mortality were observed in rats exposed for 4 -hours (whole body) to nominal concentrations of 1.8, 6.2, and 20.0 mg/L and observed for 14 days post-exposure. Clinical signs included laboured respiration and wheezing at the highest concentrations, and a subdued appearance was noted in all groups during exposure. Contrary to the two other treatment groups, here were no histopathological findings in the animals of the low concentration group. Under the conditions of this study the LC50 of the test substance was estimated to be 4.418 mg/L or ca. 667 ppm for male and female rats ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d38dd81-43d4-4d88-894b-6f44f2a002d3/documents/a95d893d-896a-412f-8434-b00e16119646_1a861a09-0462-4037-8952-903b55a18dcf.html,,,,,, "1,1,2,3,4,4-hexafluorobuta-1,3-diene",685-63-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d38dd81-43d4-4d88-894b-6f44f2a002d3/documents/a95d893d-896a-412f-8434-b00e16119646_1a861a09-0462-4037-8952-903b55a18dcf.html,,inhalation,LC50,"4,418 mg/m3",adverse effect observed, "1,1,3,3-tetrabutyl-1,3-bis[(1-oxododecyl)oxy]distannoxane",3669-02-1,"Oral:The acute oral LD50 of TK 10708 in rats of both sexes observed over 14 days is 2071 mg/kg in a study conducted using a method which is considered similar to that in OECD Guideline 401. The test material is considered to be slightly toxic to the rat by this route of administration.Dermal:The acute dermal median lethal dose (LD50) of the test material in the Wistar strain rat observed over 14 days was determined to be greater than 2000 mg/kg bodyweight (in an GLP study conducted to OECD 402). Irritation was observed, and one female animal exhibited some symptoms of toxicity, however the test material did not meet the criteria for classification as acutely toxic via the dermal route.Inhalation:A waiver has been submitted to address the acute toxicity: inhalation endpoint on the basis of lack of exposure ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61255990-cc2c-4f87-80e1-15523e4270d9/documents/af31b226-22cc-467b-a3ac-84200ac7c53a_82042487-0030-403a-abd6-50ac1a34565e.html,,,,,, "1,1,3,3-tetrabutyl-1,3-bis[(1-oxododecyl)oxy]distannoxane",3669-02-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61255990-cc2c-4f87-80e1-15523e4270d9/documents/af31b226-22cc-467b-a3ac-84200ac7c53a_82042487-0030-403a-abd6-50ac1a34565e.html,,oral,LD50,"2,071 mg/kg bw",, "1,1,3,3-tetramethylbutyl 2-ethylperoxyhexanoate",22288-43-3," The oral (gavage) administration of 1,1,3,3-Tetramethylbutyl 2-Ethylperoxyhexanoate (CAS#22288-43-3) for ninety consecutive days, to Wistar rats of both sexes, at dose levels of 10, 100 or 1000 mg/kg bw/day resulted in treatment-related body weight effects in males treated with 1000 mg/kg bw/day, hematological and blood chemical effects in either sex treated with 1000 mg/kg bw/day and microscopic abnormalities in animals of either sex treated with 1000 and 100 mg/kg bw/day. No treatment-related effects were evident in animals of either sex treated with 10 mg/kg bw/day. The ‘No Observed Effect Level’ (NOEL) for systemic toxicity was therefore considered to be 10 mg/kg bw/day for both sexes. The increase hematopoiesis in the spleen of females treated with 100 mg/kg bw/day, in isolation, was considered not to represent an adverse response to treatment; therefore, a No Observed Adverse Effect Level (NOAEL) for females was considered to be 100 mg/gk bw/day. The kidney effects detected in males treated with 1000 and 100 mg/kg bw/day were considered to represent an adverse effect of the test item, therefore, a 'No Observed Adverse Effect Level' (NOAEL) for males has not been established. However, the kidney changes of hyaline droplets were consistent with well documented changes that are peculiar to the male rat in response to treatment with some hydrocarbons. This effect is, therefore, not indicative of a hazard to human health. In the context of this study, the remaining kidney findings, consisting of basophilic tubules and proteinaceous casts in males are more likely to be correlated to the same condition as hyaline droplets and are, therefore, considered to represent limited relevance to humans. In terms of extrapolation to man and risk assessment calculations whereby effects relating to male rat renal changes are species and sex specific and therefore are not relevant, a NOAEL for males can be established at 100 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/592a5073-e6d8-492e-9844-b987c50ba30f/documents/IUC5-b3a91375-a5c6-413d-883e-dbe088764233_b609b550-cb6a-4e1e-b004-1006233857cb.html,,,,,, "1,1,3,3-tetramethylbutyl 2-ethylperoxyhexanoate",22288-43-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/592a5073-e6d8-492e-9844-b987c50ba30f/documents/IUC5-b3a91375-a5c6-413d-883e-dbe088764233_b609b550-cb6a-4e1e-b004-1006233857cb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1,1,3,3-tetramethylbutyl 2-ethylperoxyhexanoate",22288-43-3, The oral LD50 is > 2000 mg/kg bw. No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. There are no studies available for the inhalation or the dermal route. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/592a5073-e6d8-492e-9844-b987c50ba30f/documents/IUC5-cec55fdf-2728-48a3-b240-11d125dce4f1_b609b550-cb6a-4e1e-b004-1006233857cb.html,,,,,, "1,1,3,3-tetramethylbutyl hydroperoxide",5809-08-5,"A 90-day repeat dose study is available. The registered substance was administered to rats at 30, 150 and 450 mg/kg/day by gavage. Followed by a 28 day treatment free period in sub-groups of animals previously dosed at 450 mg/kg bw/day and a control group.   The NOEL from this study is 30 mg/kg bw/day. There were no effects of treatment for females that received 30 mg/kg bw/day (low dose group) and the findings observed for males at this dosage appeared to be associated with hydrocarbon nephropathy associated with α2-microglobulin. This condition, while adverse to the male rat, is deemed not to be a hazard to human health as this is principally a rodent only phenomenon, as described above.   Also in this study local effects on the stomach were seen at 150 and 450 mg/kg bw/day, as written above this finding may have limited relevance in the assessment of human health.   At 150 mg/kg bw/day, adaptive effects in the liver were seen and nephropathy as described above in males. Further, statistically significant reductions for hemoglobin, red blood cell count (RBC), haematocrit and mean cell hemoglobin concentration were apparent for males but all values were within the historical control range. Females at this dosage showed statistically significant increase for mean cell volume and mean cell hemoglobin and also decreased higher mean cell hemoglobin concentration (MCHC) but the majority of individual values were within the historical control range. These findings were similar to anemia present for both sexes at 450 mg/kg bw/day but, at this lower dosage, there was no clear effect of spleen histopathology. In the absence of such effect, and with individual erythrocyte values being generally within the normal range, these findings were considered not to represent an adverse effect at this dosage.   At 450 mg/kg bw/day several significant treatment findings were apparent for both sexes during the study. Males showed lower body weight gain and marginally lower food intake. They also had a slightly lower food conversion. The overall activity in males was lower. In both sexes statistically significant reductions for hemoglobin, red blood cell count (RBC) and hematocrit and increases in mean cell volume (MCV), mean cell hemoglobin (MCH) and a reduction in mean cell hemoglobin concentration (MCHC), significant increase in circulating neutrophils. In females higher platelets counts attained statistical significance at this dose level. Males showed slight but statistically significant increase in blood urea levels, increase in plasma glucose levels, protein and significant increase in inorganic phosphorus and lower sodium levels. Both sexes statistically significant increases in absolute and body weight relative liver weights and centrilobular hypertrophy was seen. A significant increase in absolute and relative adrenal weights were identified in both sexes accompanied by zona fasciculata hypertrophy. Significant increases in absolute and relative spleen weights were identified in both sexes with increased hematopoiesis, increased hemosiderin. One male showed an enlarged spleen and one female showed discoloration of the spleen. In both sexes statistically significant increases in absolute and body weight relative kidney weights were observed. In males this was seen together with hyaline droplets with associated pathological changes). In the thymus atrophy was present males and females. Hypertrophy of the follicular cells in the thyroid was present in 5 of 10 females. Although some of these findings were clearly adaptive in nature or of little relevance to man, the extent of findings for both sexes was considered to preclude this dosage from being considered as a NOAEL for the purposes of human risk assessment. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Adequate; the study was performed under GLP according to currrent guidelines. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0091382-b192-4a85-8a32-7ca20d7d4393/documents/IUC5-dd087f42-7bb4-48d0-9979-411d0e41a11c_ee568d82-2aff-4051-a08b-b36cfd28da34.html,,,,,, "1,1,3,3-tetramethylbutyl hydroperoxide",5809-08-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0091382-b192-4a85-8a32-7ca20d7d4393/documents/IUC5-dd087f42-7bb4-48d0-9979-411d0e41a11c_ee568d82-2aff-4051-a08b-b36cfd28da34.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "1,1,3,3-tetramethylbutyl hydroperoxide",5809-08-5,"The oral LD50 of 5809-08-5 is 820 mg/kg, the dermal LD50 is >2000 mg/kg, and the inhalation LC50 is >2.85 mg/l (480 ppm v/v). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Adequate. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Adequate. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Adequate. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0091382-b192-4a85-8a32-7ca20d7d4393/documents/IUC5-ce866574-d61e-4841-a74d-8b52c74bc677_ee568d82-2aff-4051-a08b-b36cfd28da34.html,,,,,, "1,1,3,3-tetramethylbutyl hydroperoxide",5809-08-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0091382-b192-4a85-8a32-7ca20d7d4393/documents/IUC5-ce866574-d61e-4841-a74d-8b52c74bc677_ee568d82-2aff-4051-a08b-b36cfd28da34.html,,oral,LD50,820 mg/kg bw,adverse effect observed, "1,1,3,3-tetramethylbutyl hydroperoxide",5809-08-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0091382-b192-4a85-8a32-7ca20d7d4393/documents/IUC5-ce866574-d61e-4841-a74d-8b52c74bc677_ee568d82-2aff-4051-a08b-b36cfd28da34.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,1,3,3-tetramethylbutyl hydroperoxide",5809-08-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0091382-b192-4a85-8a32-7ca20d7d4393/documents/IUC5-ce866574-d61e-4841-a74d-8b52c74bc677_ee568d82-2aff-4051-a08b-b36cfd28da34.html,,inhalation,discriminating conc.,2.85 mg/m3,adverse effect observed, "1,1,3,3-tetramethylbutyl peroxyneodecanoate",51240-95-0,"Oral 28-day (OEC407) and 90-day (OECD 408) repeated dose toxicity studies are available. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): K1: The study was performed according to OECD guidelines and GLP. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fbdb03d2-b913-4ef8-bcb9-7ca81f343d51/documents/IUC5-69045f98-3bde-4781-8af7-cfa92ab9082b_178ecea2-b831-49d9-a815-123a44f388ee.html,,,,,, "1,1,3,3-tetramethylbutyl peroxyneodecanoate",51240-95-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fbdb03d2-b913-4ef8-bcb9-7ca81f343d51/documents/IUC5-69045f98-3bde-4781-8af7-cfa92ab9082b_178ecea2-b831-49d9-a815-123a44f388ee.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1,1,3,3-tetramethylbutyl peroxyneodecanoate",51240-95-0,"The registered substance, ±70% in phlegmatizer, was not acutely toxic to rats when tested by the oral gavage route. The oral LD50 is > 5000 mg/kg bw. No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. Based on the pattern of use ingestion by humans is unlikely. An acute toxicity study via the dermal route was not performed with the registered substance since this is scientifically unjustified. Numerous organic peroxides, from different organic peroxide categories defined by chemical structure, have been tested in acute dermal toxicity tests (ca. 35 organic peroxides covering all chemical subgroups/families of organic peroxides (dialkyl peroxides, diacyl peroxides, peroxymonocarbonates, ketine peroxides, peroxydicarbonates and peroxyketals). All these organic peroxides did not show toxic effects at dermal application up to the limit dose of 2000 mg/kg bw result in an acute dermal LD50 >2000 mg/kg bw. A weight of evidence approach is therefore scientifically justified for chemically comparable organic peroxides and allows the conclusion the dermal LD50 would be in excess of 2000 mg/kg bw for the untested organic peroxide.   In this dossier the robust study summaries are included for the closest related substances belonging to the family of peroxyesters. CAS# 26748-41-4, 29240-12-3, 13122-18-4, and 22288-41-1. Also for these four substances the dermal LD50 is >2000 mg/kg bw.  Additional testing for the registered substance is therefore not required and would not be in line with animal welfare legislation.   There are no studies available for the inhalation route. In accordance with column 2 of REACH Annex VIII, the test for acute inhalation toxicity (required in section 8.5) does not need to be conducted. Testing by the inhalation route is not appropriate since exposure of humans via inhalation is not likely taking into account the very low vapour pressure and the pattern of use as this does not lead to the formation of droplets of an inhalable size. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): A K1 study is available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Multiple K1 studies from other peroxyesters. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fbdb03d2-b913-4ef8-bcb9-7ca81f343d51/documents/IUC5-837ef032-16f4-4baf-89cb-576f03cb788d_178ecea2-b831-49d9-a815-123a44f388ee.html,,,,,, "1,1,3,3-tetramethylbutylperoxypivalate",22288-41-1,"28-day Repeat Dose Oral Gavage Study – Study #1:Rats were administered 15, 150 and 1000 mg/kg/day for 28-days with a high dose recovery group. The results at this dose level were excluded from interpretation as it could not be established whether the effects in the high dose animals were induced during treatment with high doses (possibly exceeding 1000 mg/kg/day) during the first 11 days of the study and maintained in the animals by continuation of treatment at 400 mg/kg/day or should be considered to be representative of treatment at 400 mg/kg/day for a 28-day period. An additional 28-day oral toxicity study was performed to assess the toxic potential at dose levels of 150, 400 and 1000 mg/kg/day administered from homogeneous formulations (see report NOTOX project 266658).  28-day Repeat Dose Oral Gavage Study – Study #2: Rats were administered 150, 400 and 1000 mg/kg/day for 28-days with a high dose recovery group. From the results obtained after 28 days of repetitive oral treatment of rats with l,l,3,3,-TETRAMETHYLBUTYLPEROXY PIVALATE at dose levels of 150, 400 and 1000 mg/kg/day a No Observed Effect Level (NOEL) could not be established, based on the presence of kidney effects in males at all dose levels. However, it should be taken into account that these effects were the result of a species specific mechanism of toxicity, and are not relevant for risk assessment in man. Excluding the kidney effects, a No Observed Adverse Effect Level (NOAEL) for 1,1,3,3-TETRAMETHYL8UTYLPEROXY PIVALATE of 150 mg/kg/day was established for the presence of systemic effects.  Since 28 days repetitive oral treatment at 15 mg/kg/day (report of NOTOX project 256376) did not result in any effects in the stomach, a NOAEL of 15 mg/kg/day was concluded also taking into account the effects caused by local irritation in the stomach. Based on the results of the 28-day studies, the NOAEL (systemic) is 150 mg/kg/day.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Reliable without restrictions. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30a28a4b-84d7-4b66-99f4-eda5393f885a/documents/138a8466-2f36-409f-9e0a-b0d4e928af91_1e99565e-a801-4912-af2c-197a6d8a7abf.html,,,,,, "1,1,3,3-tetramethylbutylperoxypivalate",22288-41-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30a28a4b-84d7-4b66-99f4-eda5393f885a/documents/138a8466-2f36-409f-9e0a-b0d4e928af91_1e99565e-a801-4912-af2c-197a6d8a7abf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "1,1,3,3-tetramethylbutylperoxypivalate",22288-41-1,"In acute oral toxcity study (OECD 420 Fixed Dose), the LD50 (rats) was greater than 2000 mg/kg/day.In an acute dermal study (OECD 402), the LD50 (rats) was greater than 2000 mg/kg/day. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30a28a4b-84d7-4b66-99f4-eda5393f885a/documents/fd7a53d8-955d-41b8-81fc-1c02d6ef1127_1e99565e-a801-4912-af2c-197a6d8a7abf.html,,,,,, "1,1,3,3-tetramethylbutylperoxypivalate",22288-41-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30a28a4b-84d7-4b66-99f4-eda5393f885a/documents/fd7a53d8-955d-41b8-81fc-1c02d6ef1127_1e99565e-a801-4912-af2c-197a6d8a7abf.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,1,3,3-tetramethylbutylperoxypivalate",22288-41-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30a28a4b-84d7-4b66-99f4-eda5393f885a/documents/fd7a53d8-955d-41b8-81fc-1c02d6ef1127_1e99565e-a801-4912-af2c-197a6d8a7abf.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,1,3,3-tetramethyldisiloxane",3277-26-7,"In the key repeated dose inhalation study with 1,1,3,3-tetramethyldisiloxane (CAS 3277-26-7, EC 221-906-4), conducted according to OECD Test Guideline 413 and in accordance with GLP (Labcorp Early Development Laboratories, 2021, reliability 1), Wistar rats were exposed via nose only inhalation to 0, 3.06, 6.94, and 12.1 mg/l (analytical; 0, 3, 7, 12 mg/l nominal) of test item vapour for 6 hours a day, 5 or 6 days a week for 14 weeks, with a 4-week recovery period. A concentration of 12 mg/l was the maximum concentration targeted as this maintains a suitable safety margin below the lower explosive level (LEL) of 3600 ppm (21.2 mg/l). No adverse test item-related effects were observed up to 12.1 mg/l. The NOAEC for 1,1,3,3-tetramethyldisiloxane vapour was therefore concluded to be at least 12.1 mg/l. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Reliable guideline study for the inhalation route Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Reliable guideline study for the inhalation route ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45f4b7b1-388b-4ee6-8162-b704e58edd1d/documents/ffef7a9b-e95a-4db8-952d-3a85d052effc_df44b64d-b7c6-40b1-a863-c56d3a258a6d.html,,,,,, "1,1,3,3-tetramethyldisiloxane",3277-26-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45f4b7b1-388b-4ee6-8162-b704e58edd1d/documents/ffef7a9b-e95a-4db8-952d-3a85d052effc_df44b64d-b7c6-40b1-a863-c56d3a258a6d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,12 mg/L,,rat "1,1,3,3-tetramethyldisiloxane",3277-26-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45f4b7b1-388b-4ee6-8162-b704e58edd1d/documents/ffef7a9b-e95a-4db8-952d-3a85d052effc_df44b64d-b7c6-40b1-a863-c56d3a258a6d.html,Repeated dose toxicity – local effects,inhalation,NOAEC,12 mg/L,no adverse effect observed,rat "1,1,3,3-tetramethyldisiloxane",3277-26-7,"In the key acute oral toxicity study with 1,1,3,3-tetramethyldisiloxane (CAS 3277-26-7, EC 221-906-4), conducted according to OECD Test Guideline 423 and in compliance with GLP, the LD50 value was >2000 mg/kg bw (NOTOX B.V., 2007, reliability 1).   In the key acute inhalation toxicity study 1,1,3,3-tetramethyldisiloxane vapour, conducted according to OECD Test Guideline 403 with acceptable restrictions and in compliance with GLP, the 4-hour LC50 was >5.8 mg/l vapour (measured) (Dow Corning Corporation, 1994, reliability 2).   In accordance with Column 2 of REACH Annex VIII (Section 8.5), the acute dermal toxicity study with the registered substance does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in the in vivo studies with dermal exposure (e.g., skin irritation, skin sensitisation). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable guideline study for the oral route Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Reliable guideline study for the inhalation route ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45f4b7b1-388b-4ee6-8162-b704e58edd1d/documents/ce7846d0-5989-4e4a-81bb-1ea23eb201d2_df44b64d-b7c6-40b1-a863-c56d3a258a6d.html,,,,,, "1,1,3,3-tetramethyldisiloxane",3277-26-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45f4b7b1-388b-4ee6-8162-b704e58edd1d/documents/ce7846d0-5989-4e4a-81bb-1ea23eb201d2_df44b64d-b7c6-40b1-a863-c56d3a258a6d.html,,oral,LD50,">=2,000 mg/kg bw",no adverse effect observed, "1,1,3,3-tetramethyldisiloxane",3277-26-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45f4b7b1-388b-4ee6-8162-b704e58edd1d/documents/ce7846d0-5989-4e4a-81bb-1ea23eb201d2_df44b64d-b7c6-40b1-a863-c56d3a258a6d.html,,inhalation,LC50,"5,800 mg/m3",no adverse effect observed, "1,1,4,4-tetramethylbutane-1,4-diyl bis(2-ethylperoxyhexanoate)",13052-09-0,Oral NOAEL is 1000 mg/kg bw/day based on the outcome of the OECD422 study.   ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d8b8125-f690-49f0-ac1a-8ac452a47a9f/documents/6a562a76-6c34-4fe1-a32c-b32e0bc1c04b_4baf385a-670b-4d55-b7d5-d064d8997d28.html,,,,,, "1,1,4,4-tetramethylbutane-1,4-diyl bis(2-ethylperoxyhexanoate)",13052-09-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d8b8125-f690-49f0-ac1a-8ac452a47a9f/documents/6a562a76-6c34-4fe1-a32c-b32e0bc1c04b_4baf385a-670b-4d55-b7d5-d064d8997d28.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,1,4,4-tetramethylbutane-1,4-diyl bis(2-ethylperoxyhexanoate)",13052-09-0, The oral LD50 is > 2000 mg/kg bw. No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. There are no key studies available for the inhalation or the dermal route. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d8b8125-f690-49f0-ac1a-8ac452a47a9f/documents/936a9c8a-4ba5-4345-8220-5ea3a375e418_4baf385a-670b-4d55-b7d5-d064d8997d28.html,,,,,, "1,1,5,5,5-hexamethyl-3,3-bis[(trimethylsilyl)oxy]trisiloxane",3555-47-3,"In the key oral combined repeated dose toxicity study with the reproduction/developmental toxicity screening test conducted according to OECD Test Guideline 422 and in compliance with GLP, the NOAEL for 1,1,1,5,5,5-hexamethyl-3,3-bis[(trimethylsilyl)oxy]trisiloxane (CAS 3555-47-3, EC 222-613-4) for systemic parental toxicity in male and female rats was at least 1000 mg/kg bw/day based on no adverse systemic effects observed (Charles River Laboratories, 2021, reliability 1). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93d75069-36d5-4a3e-b49f-1090af1a9af0/documents/7f642a85-01a5-4212-b90b-140de62f1df2_92c4e940-57f9-4be3-8f14-bc5249d2c785.html,,,,,, "1,1,5,5,5-hexamethyl-3,3-bis[(trimethylsilyl)oxy]trisiloxane",3555-47-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93d75069-36d5-4a3e-b49f-1090af1a9af0/documents/7f642a85-01a5-4212-b90b-140de62f1df2_92c4e940-57f9-4be3-8f14-bc5249d2c785.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat "1,1,5,5,5-hexamethyl-3,3-bis[(trimethylsilyl)oxy]trisiloxane",3555-47-3,"There are no studies available for acute toxicity with the registration substance 1,1,1,5,5,5,-hexamethyl-3,3-bis[(trimethylsilyl)oxy]trisiloxane (CAS 3555-47-3, EC 222-613-4). Consequently, information has been read across from the analogue substance 1,1,1,3,5,5,5-heptamethyl-3-[(trimethylsilyl)oxy]trisiloxane (CAS 17928-28-8 EC 241-867-7). In the key acute oral toxicity study conducted according to a now deleted OECD Test Guideline 401 and not in compliance with GLP, the reported LD50 value was > 2000 mg/kg bw/day in rats (Haruna, 2001a, reliability 2). There were no studies conducted for the acute dermal and inhalation routes. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93d75069-36d5-4a3e-b49f-1090af1a9af0/documents/9d4cb1fe-583a-4809-a0c7-c20a9bafb971_92c4e940-57f9-4be3-8f14-bc5249d2c785.html,,,,,, "1,1,5,5,5-hexamethyl-3,3-bis[(trimethylsilyl)oxy]trisiloxane",3555-47-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93d75069-36d5-4a3e-b49f-1090af1a9af0/documents/9d4cb1fe-583a-4809-a0c7-c20a9bafb971_92c4e940-57f9-4be3-8f14-bc5249d2c785.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1,1'-[(3-{bis[3-(dimethylamino)propyl]amino}propyl)imino]dipropan-2-ol",2044770-20-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5277c242-d8ce-437a-a5d7-8518b529474e/documents/cb03b790-19f3-45c2-829b-2de0d0080adb_867544f3-71ed-44d8-9117-02456deae6e0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat "1,1'-[(3-{bis[3-(dimethylamino)propyl]amino}propyl)imino]dipropan-2-ol",2044770-20-7, The oral LD50 of Dabco NE1550 Catalyst is greater than 2000 mg/kg of body weight in rats and is not classified according to GHS. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5277c242-d8ce-437a-a5d7-8518b529474e/documents/cd965c8e-b41b-4a61-a1a7-5d40717d3ece_867544f3-71ed-44d8-9117-02456deae6e0.html,,,,,, "1,1'-[(3-{bis[3-(dimethylamino)propyl]amino}propyl)imino]dipropan-2-ol",2044770-20-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5277c242-d8ce-437a-a5d7-8518b529474e/documents/cd965c8e-b41b-4a61-a1a7-5d40717d3ece_867544f3-71ed-44d8-9117-02456deae6e0.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "1,1'-[(6-phenyl-1,3,5-triazine-2,4-diyl)diimino]bisanthraquinone",4118-16-5, In a GLP-compliant combined Repeated Dose Toxicity Study with a Reproduction/ Developmental Toxicity Screening no adverse effects were reported at dose levels of up to 1000 mg/kg body weight. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d5f89e90-3c87-46b2-972c-3dfd802f8469/documents/IUC5-3d240627-3245-4481-81ed-6e0fabc70664_195140ce-b7a1-4782-913c-b106464d4040.html,,,,,, "1,1'-[(6-phenyl-1,3,5-triazine-2,4-diyl)diimino]bisanthraquinone",4118-16-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d5f89e90-3c87-46b2-972c-3dfd802f8469/documents/IUC5-3d240627-3245-4481-81ed-6e0fabc70664_195140ce-b7a1-4782-913c-b106464d4040.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,1'-[(6-phenyl-1,3,5-triazine-2,4-diyl)diimino]bisanthraquinone",4118-16-5," The acute oral LD50 of the test item in Chinese hamsters of both sexes observed over a period of 14 days is greater than 6000 mg/kg. When applied dermally, the acute LD50 was greater than 2000 mg/kg as observed in rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5f89e90-3c87-46b2-972c-3dfd802f8469/documents/IUC5-fec3e75c-a088-4201-8d6e-0dd36feaa93b_195140ce-b7a1-4782-913c-b106464d4040.html,,,,,, "1,1'-[(6-phenyl-1,3,5-triazine-2,4-diyl)diimino]bisanthraquinone",4118-16-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5f89e90-3c87-46b2-972c-3dfd802f8469/documents/IUC5-fec3e75c-a088-4201-8d6e-0dd36feaa93b_195140ce-b7a1-4782-913c-b106464d4040.html,,oral,LD50,"6,000 mg/kg bw",no adverse effect observed, "1,1'-[(6-phenyl-1,3,5-triazine-2,4-diyl)diimino]bisanthraquinone",4118-16-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5f89e90-3c87-46b2-972c-3dfd802f8469/documents/IUC5-fec3e75c-a088-4201-8d6e-0dd36feaa93b_195140ce-b7a1-4782-913c-b106464d4040.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1'-[[3-(dimethylamino)propyl]imino]bispropan-2-ol",63469-23-8,"Repeated dose toxicity - oral : Two key studies are available. Martell (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test in rats according to OECD guideline 422 and according to GLP requirements. A NOAEL value > 500 mg/kg bw/day was derived for male systemic and maternal systemic toxicity. Malleshappa (2021) performed a 90-day oral repeated dose toxicity study in rats (K1) according to the OECD guideline 408 and according to GLP requirements. A NOAEL value for systemic toxicity of 150 mg/kg/day was derived.   Repeated dose toxicity - dermal : No repeated dose toxicity via dermal administration is required.   Repeated dose toxicity - inhalation : No repeated dose toxicity via inhalatory administration is required. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP-compliant, guideline study ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2e90f15-d9fb-4a50-84b4-ba02322b6f95/documents/cde4629f-051f-4586-aeb9-19956f29a943_1a9af38b-b07f-4002-bb46-2e46e3466288.html,,,,,, "1,1'-[[3-(dimethylamino)propyl]imino]bispropan-2-ol",63469-23-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2e90f15-d9fb-4a50-84b4-ba02322b6f95/documents/cde4629f-051f-4586-aeb9-19956f29a943_1a9af38b-b07f-4002-bb46-2e46e3466288.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "1,1'-[[3-(dimethylamino)propyl]imino]bispropan-2-ol",63469-23-8,"Acute toxicity - oral: A K2 key study is available (Auletta, 1979a): based on this study, the oral LD50 for male/female rats was estimated to be 2200 mg/kg body weight. The test was performed according to a method equivalent to OECD Guideline 401.In addition, a K3 supporting study is available (van Huygevoort, 2002): based on this study, the oral LD50 for female rats was considered to exceed 2000 mg/kg body weight. Acute toxicity - inhalation: In accordance with the specific rules for adaptation from column 1 (REACH Annex VII and VIII), no acute toxicity study needs to be conducted as the substance is classified as corrosive to the skin. Moreover, reliable data via two other routes of administration is available. Acute toxicity - dermal: For the dermal route, a K2 key study is available (Auletta, 1979b): based on this study, the dermal LD50 for male/female rabbits was estimated to be 3300 mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2e90f15-d9fb-4a50-84b4-ba02322b6f95/documents/3ac32c16-9337-426b-be03-78b8b0e26977_1a9af38b-b07f-4002-bb46-2e46e3466288.html,,,,,, "1,1'-[[3-(dimethylamino)propyl]imino]bispropan-2-ol",63469-23-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2e90f15-d9fb-4a50-84b4-ba02322b6f95/documents/3ac32c16-9337-426b-be03-78b8b0e26977_1a9af38b-b07f-4002-bb46-2e46e3466288.html,,oral,LD50,"2,200 mg/kg bw",adverse effect observed, "1,1'-[[3-(dimethylamino)propyl]imino]bispropan-2-ol",63469-23-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2e90f15-d9fb-4a50-84b4-ba02322b6f95/documents/3ac32c16-9337-426b-be03-78b8b0e26977_1a9af38b-b07f-4002-bb46-2e46e3466288.html,,dermal,LD50,"3,300 mg/kg bw",adverse effect observed, "1,1'-[ethane-1,2-diylbis(thio)]bisbenzene",622-20-8, Guideline acute oral toxicity study in rats indicated a low- moderate order of acute toxicity. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/300c07fc-2dfe-4659-8b56-62d795b62026/documents/0086aa31-55de-48bc-a4f6-d0b182ef6397_a661559c-0070-4f60-938d-a5f928ffd998.html,,,,,, "1,1'-[iminobis(ethyleneiminoethylene)]bis[3-(octadecenyl)pyrrolidine-2,5-dione]",64051-50-9," Repeated Dose Toxicity: Oral Route Under the conditions of the study, the No-Observed-Adverse-Effect-Level (NOAEL) was considered to be 1000 mg/kg/day. Repeated Dose Toxicity: Inhalation Route In accordance with Section 8.6.1. of Column 2 of Annex VIII of the REACH Regulation, Short-term repeated dose toxicity study (28 days) should be conducted on one species, male and female, through the most appropriate route of administration, having regard to the likely route of human exposure which in this case is the oral route. Repeated Dose Toxicity: Dermal Route In accordance with Section 8.6.1. of Column 2 of Annex VIII of the REACH Regulation, Short-term repeated dose toxicity study (28 days) should be conducted on one species, male and female, through the most appropriate route of administration, having regard to the likely route of human exposure which in this case is the oral route. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af339b5a-e921-4bd5-b93c-f7bb67e44e31/documents/c60ef70b-66fe-4cc7-8e3f-d44198fdea69_6404c927-467d-4801-a90a-24d31ef4c50e.html,,,,,, "1,1'-[iminobis(ethyleneiminoethylene)]bis[3-(octadecenyl)pyrrolidine-2,5-dione]",64051-50-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af339b5a-e921-4bd5-b93c-f7bb67e44e31/documents/c60ef70b-66fe-4cc7-8e3f-d44198fdea69_6404c927-467d-4801-a90a-24d31ef4c50e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,1'-[iminobis(ethyleneiminoethylene)]bis[3-(octadecenyl)pyrrolidine-2,5-dione]",64051-50-9," Acute oral toxicity Under the conditions of the study, the LD50 of the test material in male and female CrI:CDBR rats was estimated to be greater than 2000 mg/kg bodyweight. Acute dermal toxicity Under the conditions of the study, the LD50 has been determined to be greater than 2000 mg/kg bw in CrI:CDBR rats. Acute Inhalation Toxicity In accordance with Section 8.5.2. of Column 2 of Annex VIII of the REACH Regulation, the registrant proposes to waive the acute toxicity testing by the inhalation route on the basis that exposure to humans via inhalation is unlikely, taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af339b5a-e921-4bd5-b93c-f7bb67e44e31/documents/1b68ee13-8da7-4518-8ca6-1e6ce5f3f21a_6404c927-467d-4801-a90a-24d31ef4c50e.html,,,,,, "1,1'-[iminobis(ethyleneiminoethylene)]bis[3-(octadecenyl)pyrrolidine-2,5-dione]",64051-50-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af339b5a-e921-4bd5-b93c-f7bb67e44e31/documents/1b68ee13-8da7-4518-8ca6-1e6ce5f3f21a_6404c927-467d-4801-a90a-24d31ef4c50e.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "1,1'-[iminobis(ethyleneiminoethylene)]bis[3-(octadecenyl)pyrrolidine-2,5-dione]",64051-50-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af339b5a-e921-4bd5-b93c-f7bb67e44e31/documents/1b68ee13-8da7-4518-8ca6-1e6ce5f3f21a_6404c927-467d-4801-a90a-24d31ef4c50e.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "1,1'-[oxybis(ethyleneoxy)]diethylene",764-99-8,"The test item was administered to rats by intragastric intubation, daily, for twenty-eight consecutive days at dosage levels of 30, 100, 300 and 1000 mg/kg bw/day. The NOAEL was considered to be 1000 mg/kg bw/day in both the male and female rats (highest dose tested). A testing proposal for a sub-chronic repeated dose toxicity study in rats (OECD 408) was submitted to ECHA for evaluation. As soon as the TPE is finalized the study will be conducted and the dossier will be updated after finalization of the report. A study according OECD 422/GLP is available for the test substance. The test item was administered at 80, 250 or 800 mg/kg bw/day to Hannover Wistar rats for 28 days in males and 50-55 days in females. The NOAEL for systemic toxicity of the parental generation was 80 mg/kg bw/day for males based on clinical signs, body weight gain and food consumption effects on the high dose group and on kidney findings in male rats at the mid and high dose group. The NOAEL for systemic toxicity was 250 mg/kg bw/day for females based on clinical signs, body weight gain and food consumption effects. The NOAEL of 80 mg/kg bw/day was used for DNEL deviation. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): OECD 422/GLP ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3561b152-044e-494e-8cf6-31a0c7eef788/documents/cc713a4d-fa65-49dd-aaf0-4d787d047c04_22e6b263-385c-410f-bf16-e319144787a5.html,,,,,, "1,1'-[oxybis(ethyleneoxy)]diethylene",764-99-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3561b152-044e-494e-8cf6-31a0c7eef788/documents/cc713a4d-fa65-49dd-aaf0-4d787d047c04_22e6b263-385c-410f-bf16-e319144787a5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat "1,1'-[oxybis(ethyleneoxy)]diethylene",764-99-8,Oral: The acute oral LD50 was determined to be > 2000 mg/kg bw in rats. Dermal: The acute dermal LD50 was determined to be > 2000 mg/kg bw in rabbits.Inhal.: The LD50 in the inhalation risk test was determined to be > 9 mg/l. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3561b152-044e-494e-8cf6-31a0c7eef788/documents/d71127fb-a206-4b60-9634-a87219db3e76_22e6b263-385c-410f-bf16-e319144787a5.html,,,,,, "1,1'-[oxybis(ethyleneoxy)]diethylene",764-99-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3561b152-044e-494e-8cf6-31a0c7eef788/documents/d71127fb-a206-4b60-9634-a87219db3e76_22e6b263-385c-410f-bf16-e319144787a5.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,1'-[oxybis(ethyleneoxy)]diethylene",764-99-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3561b152-044e-494e-8cf6-31a0c7eef788/documents/d71127fb-a206-4b60-9634-a87219db3e76_22e6b263-385c-410f-bf16-e319144787a5.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,1'-{(phenylmethanediyl)bis[(3-substituted benzene-4,1-diyl)diazene-2,1-diyl{1-[3-(dimethylamino)propyl]-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridine-5,3-diyl}]}dipyridinium chloride lactate salts",1062263-18-6,"Acute toxicity:Oral rat (Acute toxic class method): discriminating dose: 50 mg*/kg bw: 100% survival but evident toxicity;High mortality at 300* mg/kg (67% mortality) and 2000 mg*/kg (100% mortality).Classification:""harmful (Xn)"" and ""harmful if swallowed (R22)"" [DIRECTIVE 67/548/EEC] and""Category 3 (Danger, Toxic if swallowed)"" [REGULATION (EC) 1272/2008].Dermal rat: LD50 > 2000 mg*/kg bw (10% mortality at 2000 mg*/kg bw)Classification: No labelling requirement regarding acute dermal toxicity [DIRECTIVE 67/548/EEC and Reg. (EC) 1272/2008] ______________________________________________________________________________________________________________ * Expressed as water- and minor impurity-free test substance ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e924de9a-b172-4969-a724-75728db0f135/documents/IUC5-8c0ae1c7-06b0-40a2-a12a-ca5a923e5a6a_44c07cbf-8103-4a6e-a405-b30f887d8746.html,,,,,, "1,1'-{(phenylmethanediyl)bis[(3-substituted benzene-4,1-diyl)diazene-2,1-diyl{1-[3-(dimethylamino)propyl]-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridine-5,3-diyl}]}dipyridinium chloride lactate salts",1062263-18-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e924de9a-b172-4969-a724-75728db0f135/documents/IUC5-8c0ae1c7-06b0-40a2-a12a-ca5a923e5a6a_44c07cbf-8103-4a6e-a405-b30f887d8746.html,,oral,discriminating dose,50 mg/kg bw,, "1,1'-{(phenylmethanediyl)bis[(3-substituted benzene-4,1-diyl)diazene-2,1-diyl{1-[3-(dimethylamino)propyl]-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridine-5,3-diyl}]}dipyridinium chloride lactate salts",1062263-18-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e924de9a-b172-4969-a724-75728db0f135/documents/IUC5-8c0ae1c7-06b0-40a2-a12a-ca5a923e5a6a_44c07cbf-8103-4a6e-a405-b30f887d8746.html,,dermal,LD50,"2,000 mg/kg bw",, "1,1’,1’’-((methylsilanetriyl)tris(oxy))tris(butan-2-amine)",28911-49-1, Studies on acute toxicity do not need to be conducted because the substance is classified as corrosive to skin (Cat.1B). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/631bd9a3-6f5d-4573-a6e1-19c0a0b63717/documents/8d5fdc1b-2008-4ce1-b71f-8519b5c0e5d3_d5229856-0208-4385-a475-2a6ce956a10b.html,,,,,, "1,10-Decanediamine, 4-methylbenzenesulfonate (1:2)",1326716-46-4," The acute oral LD50 of 1,10 -Decanediamine, 4 -methylbenzenesulfonate (Trade name: Clevios K Primer W8 dry) was found to be between 2000 - 5000 mg/kg bw. Clevios K Primer W8 dry is included in Category 5, according to the Globally Harmonised System (GHS). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1bdb818-fc2c-45dc-a4c4-5c1949bb2755/documents/c9e1ede5-5561-4983-a7ee-2cb734572d8d_aec3e6c5-48bd-4102-ad04-9a05bc109204.html,,,,,, "1,10-Decanediamine, 4-methylbenzenesulfonate (1:2)",1326716-46-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1bdb818-fc2c-45dc-a4c4-5c1949bb2755/documents/c9e1ede5-5561-4983-a7ee-2cb734572d8d_aec3e6c5-48bd-4102-ad04-9a05bc109204.html,,oral,LD50,"5,000 mg/kg bw",adverse effect observed, "1,10-decanediyl bismethacrylate",6701-13-9," No repeated data is available on 1,10 decanediyl bis methacrylate. However, a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test according to OECD Guideline 422 is available on an analogue substance of 1,10 decanediyl bis methacrylate, 1,4-Butanediol dimethacrylate. On the basis of the results obtained in this study, the NOAEL (No Observed Adverse Effect Level) for general systemic toxicity is considered to be 300 mg/kg/day for males and females. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ead58246-d1a1-4273-93f3-fc3a01b3c60d/documents/38adb3de-8c24-4f4e-baf0-f3e7fb6bf0f2_a2d8d28a-264c-4cb5-a74a-38960e8d3398.html,,,,,, "1,10-decanediyl bismethacrylate",6701-13-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ead58246-d1a1-4273-93f3-fc3a01b3c60d/documents/38adb3de-8c24-4f4e-baf0-f3e7fb6bf0f2_a2d8d28a-264c-4cb5-a74a-38960e8d3398.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "1,10-decanediyl bismethacrylate",6701-13-9," The potential of acute toxicity of 1,10-decanediol diacrylate was evaluated in two studies, one by oral route and one by dermal route. No mortalities were showed in both studies; the oral and dermal LD50 were higher than 5000 and 2000 mg/kg in rats, respectively.  ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ead58246-d1a1-4273-93f3-fc3a01b3c60d/documents/60b8742c-6bc5-4c34-bb5b-06d43564774a_a2d8d28a-264c-4cb5-a74a-38960e8d3398.html,,,,,, "1,10-decanediyl bismethacrylate",6701-13-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ead58246-d1a1-4273-93f3-fc3a01b3c60d/documents/60b8742c-6bc5-4c34-bb5b-06d43564774a_a2d8d28a-264c-4cb5-a74a-38960e8d3398.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "1,10-decanediyl bismethacrylate",6701-13-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ead58246-d1a1-4273-93f3-fc3a01b3c60d/documents/60b8742c-6bc5-4c34-bb5b-06d43564774a_a2d8d28a-264c-4cb5-a74a-38960e8d3398.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,10-decanediyl diacrylate",13048-34-5,"A Combined 28-Day Repeated Dose Oral (Gavage) Toxicity Study with the Reproduction/Developmental Toxicity Screening Test is available on 1,10-decanediol diacrylate. Based on the results of this study, the No Observed Effect Level (NOAEL) for parental toxicity was considered to be 1000 mg/kg bw/day based on the absence of adverse effects at this dose level. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The key study is GLP-compliant and of high quality (Klisch score = 1). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/720845cc-48c9-41f3-ab35-83b2a7500a37/documents/IUC5-5672a80e-bf90-486e-9358-11e35a05f009_6b688cce-2ce5-4166-bb03-9584e86b07d2.html,,,,,, "1,10-decanediyl diacrylate",13048-34-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/720845cc-48c9-41f3-ab35-83b2a7500a37/documents/IUC5-5672a80e-bf90-486e-9358-11e35a05f009_6b688cce-2ce5-4166-bb03-9584e86b07d2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,10-decanediyl diacrylate",13048-34-5,"The potential of acute toxicity of 1,10-decanediol diacrylate was evaluated in two studies, one by oral route and one by dermal route. No mortalities were showed in both studies; the oral and dermal LD50 were higher than 2000 mg/kg in rats. No data is available by inhalation on 1,10-decanediol diacrylate. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The oral acute study is considered to be a reliable study (klimisch score of 1). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The dermal acute study is considered to be a reliable study (klimisch score of 1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/720845cc-48c9-41f3-ab35-83b2a7500a37/documents/IUC5-3fca44c2-9790-4b1e-8c33-87b1c61b736d_6b688cce-2ce5-4166-bb03-9584e86b07d2.html,,,,,, "1,10-decanediyl diacrylate",13048-34-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/720845cc-48c9-41f3-ab35-83b2a7500a37/documents/IUC5-3fca44c2-9790-4b1e-8c33-87b1c61b736d_6b688cce-2ce5-4166-bb03-9584e86b07d2.html,,oral,LD0,"2,000 mg/kg bw",no adverse effect observed, "1,10-decanediyl diacrylate",13048-34-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/720845cc-48c9-41f3-ab35-83b2a7500a37/documents/IUC5-3fca44c2-9790-4b1e-8c33-87b1c61b736d_6b688cce-2ce5-4166-bb03-9584e86b07d2.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, "1,12-dodecanediyl bismethacrylate",72829-09-5," The potential of acute toxicity of 1,12-decanediol bismethacrylate is evaluated by oral with an acute toxicity study performed on an analogue substance: 1,10-decanediol diacrylate. No mortalities were showed so the oral LD50 is higher than 2000 mg/kg in rats.    ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8bda608-4b15-4888-8020-41d72760e79a/documents/2cfb5aaa-4777-4a7f-b502-44f5d90723e4_8d529abe-65fe-4e73-bb2b-7bf7c0e12180.html,,,,,, "1,12-dodecanediyl bismethacrylate",72829-09-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8bda608-4b15-4888-8020-41d72760e79a/documents/2cfb5aaa-4777-4a7f-b502-44f5d90723e4_8d529abe-65fe-4e73-bb2b-7bf7c0e12180.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "trans,trans-4-((E)-propen-1-yl)-4'-propyl-bicyclohexane",279246-65-0, The No Observed Adverse Effect Level (NOAEL) in Wistar (Han) rats was established at 100 mg/kg/d. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d9b95d0-d2cb-41d9-99eb-1aeee99e8981/documents/0ede2721-06df-4e6c-8583-85343f1dc24e_7817b0c8-f4f5-4a3f-87af-7b861df074eb.html,,,,,, "trans,trans-4-((E)-propen-1-yl)-4'-propyl-bicyclohexane",279246-65-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d9b95d0-d2cb-41d9-99eb-1aeee99e8981/documents/0ede2721-06df-4e6c-8583-85343f1dc24e_7817b0c8-f4f5-4a3f-87af-7b861df074eb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "trans,trans-4-((E)-propen-1-yl)-4'-propyl-bicyclohexane",279246-65-0," The acute toxicity of the test item was investigated in an acute toxicity study on rats. The test animals showed no clinical signs (and no mortality) up to the limit dose after oral administration. Hence, the LD50 is above 2000 mg/Kg bw. The subsequent evaluation on the necessity of a acute test via a second route was done in accordance with Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance, Version 6.0, July 2017, p 374f. A DermWin calculation shows a dermally absorbed dose of 6.2*10 -6 to 5.8*10 -5 mg/cm2/event. Based on the very low dermally absorbed rate and the absence of systemic effects after acute oral administration, a study on acute dermal toxicity is not required. Furthermore, based on the lack of systemic toxicity after acute oral adminsitration, it is more than evident that an acute study on inhalation would not show any different outcome. Therefore, and due to animal welfare reasons a study on acute inhalation is not required. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d9b95d0-d2cb-41d9-99eb-1aeee99e8981/documents/bb516b79-ed57-457d-9a6d-b93c621905af_7817b0c8-f4f5-4a3f-87af-7b861df074eb.html,,,,,, "trans,trans-4-((E)-propen-1-yl)-4'-propyl-bicyclohexane",279246-65-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d9b95d0-d2cb-41d9-99eb-1aeee99e8981/documents/bb516b79-ed57-457d-9a6d-b93c621905af_7817b0c8-f4f5-4a3f-87af-7b861df074eb.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4-trans-Propyl-4-trans-vinyl-[1,1-bicylohexyl]",116020-44-1," The informtion for this endpoint study record was obtained from an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 408. Daily oral treatment with 5, 20 and 100 mg/kg the test material  to Wistar (Han) rats was clinically tolerated over 90 days. The No Observed Adverse Effect Level (NOAEL) in Wistar (Han) rats was established at 100 mg/kg/d. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be07727f-fd85-4709-921c-ca13f048143d/documents/IUC5-7ed3ce13-8cbe-429a-b129-eb7b580c61fa_8a68d4ba-abb2-4e26-9b97-258e0810f01c.html,,,,,, "4-trans-Propyl-4-trans-vinyl-[1,1-bicylohexyl]",116020-44-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be07727f-fd85-4709-921c-ca13f048143d/documents/IUC5-7ed3ce13-8cbe-429a-b129-eb7b580c61fa_8a68d4ba-abb2-4e26-9b97-258e0810f01c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "4-trans-Propyl-4-trans-vinyl-[1,1-bicylohexyl]",116020-44-1," The acute toxicity of the test item was investigated in an acute toxicity study on rats. The test animals showed no clinical signs (and no mortality) up to the limit dose after oral administration. Hence, the LD50 is above 2000 mg/Kg bw. The subsequent evaluation on the necessity of a acute test via a second route was done in accordance with Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance, Version 6.0, July 2017, p 374f. A DermWin calculation shows a dermally absorbed dose of 1*10 -5 to 8.7 -10 -5 mg/cm2/event. Based on the very low dermally absorbed rate and the absence of systemic effects after acute oral administration, a study on acute dermal toxicity is not required. Furthermore, based on the lack of systemic toxicity after acute oral adminsitration, it is more than evident that an acute study on inhalation would not show any different outcome. Therefore, and due to animal welfare reasons a study on acute inhalation is not required. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be07727f-fd85-4709-921c-ca13f048143d/documents/IUC5-56320ccd-6a41-4c06-94c3-9f3e1a58c079_8a68d4ba-abb2-4e26-9b97-258e0810f01c.html,,,,,, "4-trans-Propyl-4-trans-vinyl-[1,1-bicylohexyl]",116020-44-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be07727f-fd85-4709-921c-ca13f048143d/documents/IUC5-56320ccd-6a41-4c06-94c3-9f3e1a58c079_8a68d4ba-abb2-4e26-9b97-258e0810f01c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1'-diethyl[3,3'-bianthra[1,9-cd]pyrazole]-6,6'(1H,1'H)-dione",4203-77-4, LD50 > 10000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/006ff550-b01f-4032-8da1-d1f00da24d7b/documents/f9e8fc8d-a134-4ea3-9e90-f274a731c15f_6ec50f4f-070a-43cc-be6a-eee2d50f4b35.html,,,,,, "1,1-dimethoxyethane",534-15-6, The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System — Category 5). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e79f29a-03ff-4758-9b00-841a47eb6f36/documents/0462f2d3-4dbf-407e-9e1a-8b764a744f5d_8f45e9ec-e880-46b1-9c18-bf08e41d4d57.html,,,,,, "1,1-dimethoxyethane",534-15-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e79f29a-03ff-4758-9b00-841a47eb6f36/documents/0462f2d3-4dbf-407e-9e1a-8b764a744f5d_8f45e9ec-e880-46b1-9c18-bf08e41d4d57.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1-dimethylheptanethiol",25360-10-5,"No key repeat dose toxicity data are available for 1,1-dimethylheptanethiol. Following repeated inhalation exposures (28-days) to structural analogue tert-dodecanethiol, mild kidney effects (renal tubular degeneration similar to that seen with branched chain hydrocarbons) were reported in male rats at 26 and 98 ppm, while liver enlargement was reported in rats at 98 ppm and in mice and dogs at 109 ppm. Effects on ovaries were also seen in mice exposed to 109 ppm. Mice and dogs exposed to tert-dodecanethiol at a level of 26 ppm for 28-days did not show any signs of toxicity. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d4dba97-0859-4b81-a69a-485748679bf7/documents/IUC5-c246c62c-791c-453a-9488-2fc8a0dc8756_12dd19c8-b52c-4b98-8cef-bb475b3d7fae.html,,,,,, "1,1-dimethylheptanethiol",25360-10-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d4dba97-0859-4b81-a69a-485748679bf7/documents/IUC5-c246c62c-791c-453a-9488-2fc8a0dc8756_12dd19c8-b52c-4b98-8cef-bb475b3d7fae.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,215 mg/m3,,rat "1,1-dimethylheptanethiol",25360-10-5,"Key data were identified to evaluate the acute oral, dermal, and inhalation toxicity potential of 1,1-dimethylheptanethiol. The key parameters are discussed below: • Acute oral LD50: 5550 mg/kg bw • Acute dermal LD50: >2000 mg/kg bw• Acute inhalation LC50: >7.04 mg/L ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d4dba97-0859-4b81-a69a-485748679bf7/documents/IUC5-9395e21c-6560-485c-a99d-d5f284148f4d_12dd19c8-b52c-4b98-8cef-bb475b3d7fae.html,,,,,, "1,1-dimethylheptanethiol",25360-10-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d4dba97-0859-4b81-a69a-485748679bf7/documents/IUC5-9395e21c-6560-485c-a99d-d5f284148f4d_12dd19c8-b52c-4b98-8cef-bb475b3d7fae.html,,oral,LD50,"5,550 mg/kg bw",, "1,1-dimethyl-N,N'-bis(1-methylpropyl)silanediamine",93777-98-1," Based on the available information from the key acute oral toxicity study the LD50 for 1,1-dimethyl-N,N'-bis(1-methylpropyl)silanediamine was concluded to be 907.45 mg/kg bw. The study was conducted according to OECD test guideline 401 and in compliance with GLP (Pharmakon, 1993). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc655a83-f467-4ddc-809c-c0041656fa8d/documents/IUC5-871c7805-cc95-44d3-b249-465745b071bc_cc5eb6e4-14b1-4d1e-a6bd-f90043f6fbfe.html,,,,,, "1,1-dimethyl-N,N'-bis(1-methylpropyl)silanediamine",93777-98-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc655a83-f467-4ddc-809c-c0041656fa8d/documents/IUC5-871c7805-cc95-44d3-b249-465745b071bc_cc5eb6e4-14b1-4d1e-a6bd-f90043f6fbfe.html,,oral,LD50,907.45 mg/kg bw,adverse effect observed, "1,1-dimethylprop-3-ynylamine",2978-58-7, The acute oral LD50 was determined to be 1470.0 mg/kg bw in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5bf2f69-3a8b-44a3-a8b6-fa7b79f17a11/documents/4890883a-580f-4451-98e4-c1af135f12df_93c3cd1a-bf79-4191-890a-ffce27411433.html,,,,,, "1,1-dimethylprop-3-ynylamine",2978-58-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5bf2f69-3a8b-44a3-a8b6-fa7b79f17a11/documents/4890883a-580f-4451-98e4-c1af135f12df_93c3cd1a-bf79-4191-890a-ffce27411433.html,,oral,LD50,"1,470 mg/kg bw",adverse effect observed, "1,1-dimethylurea",598-94-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad9a65de-38ef-424b-94b9-9eab721529bc/documents/adf9d60e-4b77-4a2b-b063-69adbcef96b3_e2495431-cf7c-4991-88fc-819a032789dc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,540 mg/kg bw/day,,rat "1,1-dimethylurea",598-94-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): According to the results of a preliminary experiment it is impossible to perform an inhalation test with 1,1-Dimethylurea as the substance cannot be generated to dust due to the high hygroscopicity. Furthermore a aqueous solution of 1,1-Dimethylurea failed to be atomized because of uncontrolled bulk crystallization. Because of this two reasons an acute inhalation study is technically not feasible. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad9a65de-38ef-424b-94b9-9eab721529bc/documents/IUC5-56d7248a-46a4-4407-a1af-4ef16e9b7ebb_e2495431-cf7c-4991-88fc-819a032789dc.html,,,,,, "1,1'-dithiobis[hexahydro-2H-azepin-2-one]",23847-08-7," subacute oral repeated dose (2012), 28 days, rats, oral gavage, NOAEL (local effects in forestomach) = 40 mg/kg bw, NOAEL (systemic effects) > 160 mg/kg bw subchronic oral repeated dose study (OECD 408, GLP), 13 weeks, Wister rats m/f, NOAEL (systemic and local) >= 140 mg/kg bw/d ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9de279d4-1a56-4095-8b4a-8083bc2cf261/documents/eed56a89-1d0c-4fad-ab93-e1a8869beb61_77348102-82cf-44a9-b7c7-75c9f5ce0472.html,,,,,, "1,1'-dithiobis[hexahydro-2H-azepin-2-one]",23847-08-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9de279d4-1a56-4095-8b4a-8083bc2cf261/documents/eed56a89-1d0c-4fad-ab93-e1a8869beb61_77348102-82cf-44a9-b7c7-75c9f5ce0472.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,140 mg/kg bw/day,,rat "1,1'-dithiobis[hexahydro-2H-azepin-2-one]",23847-08-7,"1. Acute oral toxicity (2011), GLP, OECD 423, rats, gavage, 2000 mg/kg, LD50 >2000 mg/kg bw2. Acute dermal toxicity (2011), GLP, OECD 402, rats, semiocclusive, 24 hours, LD50 > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9de279d4-1a56-4095-8b4a-8083bc2cf261/documents/IUC5-d01fa72d-b7a2-4191-8e35-6ca6d03c9256_77348102-82cf-44a9-b7c7-75c9f5ce0472.html,,,,,, "1,1'-dithiobis[hexahydro-2H-azepin-2-one]",23847-08-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9de279d4-1a56-4095-8b4a-8083bc2cf261/documents/IUC5-d01fa72d-b7a2-4191-8e35-6ca6d03c9256_77348102-82cf-44a9-b7c7-75c9f5ce0472.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1'-dithiobis[hexahydro-2H-azepin-2-one]",23847-08-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9de279d4-1a56-4095-8b4a-8083bc2cf261/documents/IUC5-d01fa72d-b7a2-4191-8e35-6ca6d03c9256_77348102-82cf-44a9-b7c7-75c9f5ce0472.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1'-isopropylidenebis(ethylferrocene)",37206-42-1," For acute oral toxicity read-across data is presented from studies on substances structurally related to 1,1""-isopropylidenebis(ethylferrocene), CAS Number 37206 -42 -1, EC Number 310 -202 -3, those substances being :- 1,1'-Bis(ferrocenyl)octane, CAS Number 501410-94-2, EC Number 479-710-1 and Iron(2+) dicyclopenta-2,4-dienide (Ferrocene), CAS Number 102-54-5, EC Number 203-039-3. Two studies are presented on structurally related substances as valid read across candidates: 1,1'-Bis(ferrocenyl)octane, CAS Number 501410-94-2, EC Number 479-710-1 (OECD 423) and Iron(2+) dicyclopenta-2,4-dienide (Ferrocene), CAS Number 102-54-5, EC Number 203-039-3 (equivalent or similar to OECD 401). In an OECD 423 study, 1,1'-Bis(ferrocenyl)octane, has an LD50 of > 2000 mg/kg/bw. The LD0 therefore is 2000 mg/kg/bw. In the case of iron (2 +) dicyclopenta-2,4 -dienide (ferrocene), CAS Number 102 -54 -5, EC Number 203 -039 -3, the acute oral toxicity was investigated in a study which was equivalent or similar to guideline OECD 401 and published in Patty's Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y. [2001]., p. V2 42; Peer Reviewed; authors Bingham, E.; Cohrssen, B.; Powell, C.H. In this study, ferrocene is reported to have an LD50 of 1320 mg/kg/bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcad23d6-72a9-4442-bf1c-cfbf3f2afc90/documents/6fe222fb-8337-4095-9553-1128cf312a39_5957a8d3-b3a8-4e09-a66a-84fa9c37bc1a.html,,,,,, "1,1'-isopropylidenebis(ethylferrocene)",37206-42-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcad23d6-72a9-4442-bf1c-cfbf3f2afc90/documents/6fe222fb-8337-4095-9553-1128cf312a39_5957a8d3-b3a8-4e09-a66a-84fa9c37bc1a.html,,oral,LD50,"1,320 mg/kg bw",adverse effect observed, "1,1'-isopropylidenebis[4-(allyloxy)-3,5-dibromobenzene]",25327-89-3, The test substance was evalueted for its acute oral toxicity potential in rats. The study was performed according to GLP following oral administration of a single dose to the rats. No mortality occurred during the study and no abnormalities were observed. There was no effect on body weight gain. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The acute oral LD50 was determined to be greater than 5000 mg/kg bw. The test substance was evalueted for its acute dermal toxicity potential in rabbits. The study was performed according to GLP following dermal administration of a single dose to the rabbits. No mortality occurred during the study and there was no effect on body weight gain. Moderate to slight erythema and edema decreasing in severity and area with time. Five/ten animals appeared normal by day 2. Ten/ten animals appeared normal by day 7. The gross necropsy conducted at termination of the study revealed no observable abnormalities. The acute dermal LD50 was determined to be greater than 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5763a4e8-8e62-4306-b40a-6de002919f34/documents/141cad43-b6f6-4814-b4f2-ba7afa3c8376_c7e91788-bd7b-4528-8460-83f344444c39.html,,,,,, "1,1'-isopropylidenebis[4-(allyloxy)-3,5-dibromobenzene]",25327-89-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5763a4e8-8e62-4306-b40a-6de002919f34/documents/141cad43-b6f6-4814-b4f2-ba7afa3c8376_c7e91788-bd7b-4528-8460-83f344444c39.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "1,1'-isopropylidenebis[4-(allyloxy)-3,5-dibromobenzene]",25327-89-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5763a4e8-8e62-4306-b40a-6de002919f34/documents/141cad43-b6f6-4814-b4f2-ba7afa3c8376_c7e91788-bd7b-4528-8460-83f344444c39.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "1,1''-isopropylidenediferrocene",12609-95-9," Two studies are presented on structurally related substances as valid read across candidates: 1,1'-Bis(ferrocenyl)octane, CAS Number 501410-94-2, EC Number 479-710-1 (OECD 423) and Iron(2+) dicyclopenta-2,4-dienide (Ferrocene), CAS Number 102-54-5, EC Number 203-039-3 (equivalent or similar to OECD 401). In an OECD 423 study, 1,1'-Bis(ferrocenyl)octane, has an LD50 of > 2000 mg/kg/bw. The LD0 therefore is 2000 mg/kg/bw. In the case of iron (2 +) dicyclopenta-2,4 -dienide (ferrocene), CAS Number 102 -54 -5, EC Number 203 -039 -3, the acute oral toxicity was investigated in a study which was equivalent or similar to guideline OECD 401 and published in Patty's Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y. [2001]., p. V2 42; Peer Reviewed; authors Bingham, E.; Cohrssen, B.; Powell, C.H. In this study, ferrocene is reported to have an LD50 of 1320 mg/kg/bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe743af7-28ac-4609-991a-7314d149dd83/documents/d854039c-4093-457f-9e49-f07d7b70be43_a11b8a7f-c13e-4b3d-be11-02fe502804d6.html,,,,,, "1,1''-isopropylidenediferrocene",12609-95-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe743af7-28ac-4609-991a-7314d149dd83/documents/d854039c-4093-457f-9e49-f07d7b70be43_a11b8a7f-c13e-4b3d-be11-02fe502804d6.html,,oral,LD50,"1,320 mg/kg bw",adverse effect observed, "1,1'-methylenebis[4-fluorobenzene]",457-68-1,Toxicity completed as a solution in petroleum spirit. Assuming all toxicity is as a consequence of DFDPM we can calculate and oral LD50. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aebdd0c-8b94-4d5a-ac73-7f038e0e32f2/documents/IUC5-e9e2c339-40fb-44ab-bc77-5bbf4892f362_7b16b1b0-3b50-4477-baa1-bfd7b80aa7ac.html,,,,,, "1,1'-methylenebis[4-fluorobenzene]",457-68-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aebdd0c-8b94-4d5a-ac73-7f038e0e32f2/documents/IUC5-e9e2c339-40fb-44ab-bc77-5bbf4892f362_7b16b1b0-3b50-4477-baa1-bfd7b80aa7ac.html,,oral,LD50,924 mg/kg bw,, "1,2,2,6,6-pentamethylpiperidin-4-ol",2403-89-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/796d1e6d-33bd-4ae4-b967-c56307097da9/documents/IUC5-55dbcbbe-dc41-4805-aeb3-7527b4cec3c9_5cae494a-f864-4ac1-ac97-8d4ddb4a2e4d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,226 mg/kg bw/day,,rat "1,2,2,6,6-pentamethylpiperidin-4-ol",2403-89-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/796d1e6d-33bd-4ae4-b967-c56307097da9/documents/IUC5-b64b29c9-a1a3-4ca4-a41c-5b5c2a5ff1f6_5cae494a-f864-4ac1-ac97-8d4ddb4a2e4d.html,,oral,LD50,"1,285 mg/kg bw",adverse effect observed, "1,2,3,4-Butanetetracarboxylic acid, tetramethyl ester, reaction products with 1,2,2,6,6-pentamethyl-4-piperidinol and β,β,β',β'-tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol",85631-00-1," In conclusion, based on the findings of this study, due to the irritant nature of the test item, the prolonged treatment period at 50 mg/kg bw/day (maximum dose) showed an adverse reduction in body weight development throughout the treatment period in males resulting in 71% lower overall body weight gain compared to controls, which accompanied reduction in food consumption. These effects were initially observed in all female treatment groups during Week 1 however recovery was evident thereafter. At 25 mg/kg bw/day males exhibited slight fluctuations in body weight gains during treatment resulting in lower overall body weight (13%) compared to controls. These findings were considered to be associated with the irritant/sensitising properties of the test item as identified in the Fourteen Day Range Finding Study (Envigo Study number: QB15NM), Acute Eye Irritation (Envigo Study number: WB71VG) performed to OECD TG405 and Local Lymph Node Assay (Envigo Study number: 1824100) performed to OECD TG429. Although there were adverse effects at 50 mg/kg bw/day (maximum dose), there was no evidence of adverse target organ effects, hence, this may not be indicative of true systemic toxicity. Taking this into account the No Observed Adverse Effect Level (NOAEL) for toxicity could therefore be considered to be at least 50 mg/kg bw/day (maximum dose) for animals of either sex. The ‘No Observed Effect Level’ (NOEL) for reproductive and developmental toxicity was considered to be 50 mg/kg bw/day (maximum dose). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/946f3f6c-f94d-466e-a51f-0c485a95cdba/documents/b6c72991-ab10-42e9-8180-c1c4cc28f3de_97b17e75-9957-464f-a802-961cdd5374f7.html,,,,,, "1,2,3,4-Butanetetracarboxylic acid, tetramethyl ester, reaction products with 1,2,2,6,6-pentamethyl-4-piperidinol and β,β,β',β'-tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol",85631-00-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/946f3f6c-f94d-466e-a51f-0c485a95cdba/documents/b6c72991-ab10-42e9-8180-c1c4cc28f3de_97b17e75-9957-464f-a802-961cdd5374f7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "1,2,3,4-Butanetetracarboxylic acid, tetramethyl ester, reaction products with 1,2,2,6,6-pentamethyl-4-piperidinol and β,β,β',β'-tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol",85631-00-1, The acute median lethal oral dose (LD50) to rats was demonstrated to be between 300 and 2000mg/kg body weight. According to the CLP criteria LA-63P is classified as category 4 for Acute Oral Toxcitiy- H302 Harmful if swallowed. The acute dermal median dose (LD50) to rats was demonstrated to be greater than 2000mg/kg body weight. According to the CLP criteria this dose does not meet the criteria for classification therefore LA-63P is unclssified for Acute dermal toxicity. The inhalation study was waived therefore this endpoint is determined to be non hazardous. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/946f3f6c-f94d-466e-a51f-0c485a95cdba/documents/d402f889-5bf0-4ac9-944b-7f8ac9ab480d_97b17e75-9957-464f-a802-961cdd5374f7.html,,,,,, "1,2,3,4-Butanetetracarboxylic acid, tetramethyl ester, reaction products with 1,2,2,6,6-pentamethyl-4-piperidinol and β,β,β',β'-tetramethyl-2,4,8,10-tetraoxaspiro[5.5]undecane-3,9-diethanol",85631-00-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/946f3f6c-f94d-466e-a51f-0c485a95cdba/documents/d402f889-5bf0-4ac9-944b-7f8ac9ab480d_97b17e75-9957-464f-a802-961cdd5374f7.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "1,2,3,4-tetrahydro-1-naphthylamine",2217-40-5,The median lethal dose of 1-Aminotetralin after oral administration was found to be greater than 300 mg/kg and less than 500 mg/kg body weight in rats (OECD 423). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d252b0e-c1fc-41ca-811b-961bd54e2f91/documents/IUC5-b92065d0-cd69-4497-9ed6-0a4601da155d_6db65ed4-a4d8-4ecf-b861-917b3991d820.html,,,,,, "1,2,3,4-tetrahydroisoquinoline",91-21-4,"In a repeated-dose (90-day) inhalation toxicity study (GLP-compliant, OECD TG 413) 5.2 mg/m³ (actual concentration; vapour) was a No-Observed-Adverse-Effect Concentration (NOAEC) in male and female rats. At higher concentrations (24.7 and 75.1 mg/m³) clinical signs indicative of irritation, slightly decreased growth rate and food consumption, some biochemical alterations and histopathological changes at the base of the epiglottis were observed. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/30954f71-c783-4480-ab6e-711569cb9c80/documents/IUC5-a26552a6-dfe5-419b-b98a-64846781c93a_8d34e668-5b48-41cb-b41f-acccb7e54ef3.html,,,,,, "1,2,3,4-tetrahydroisoquinoline",91-21-4,"- Oral LD50 about 300 mg/kg bw for rat.- Dermal LD50 <1000 mg/kg bw for rat (100% mortality at 1000 mg/kg bw, only this dose was tested).- Inhalation LC50 (4-hour) 1.881 mg/L for rat (95% confidence interval 1.222 - 3.115 mg/L; test atmospheres were mixtures of liquid aerosol and vapour). ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30954f71-c783-4480-ab6e-711569cb9c80/documents/IUC5-7239b88d-3383-4dd0-b8db-12096ebd9080_8d34e668-5b48-41cb-b41f-acccb7e54ef3.html,,,,,, "1,2,3,4-tetrahydronaphthalene",119-64-2," Partly cited from SIAR to SIAM 19 (Berlin, 19-22 October 2004): In a 28 day toxicity study in rats with gavage application of up to 150 mg 1,2,3,4-tetrahydronaphthalene/kg bw/day, no mortalities occurred in any group. Squatting position and closed eyes were observed in all treated groups. There was a transient decrease in absolute body weights of all treated males. Results of hematology were indicative for a hemolytic anemia in males and females of the high dose group, which was still present, though to a lesser degree, at the end of the recovery period. As a secondary reaction to the anemia, the reticulocyte counts for high dose females were increased and the extramedullary hematopoesis in the spleen of both high dose genders was enhanced. Based on the adverse effects on blood and spleen (significant at 150 mg/kg bw/day but already beginning at 50 mg/kg bw/day), the NOAEL in this study was at 50 mg/kg bw /day (Hüls AG 1995). In 13-week inhalation studies on rats and mice (performed within the U.S. National Toxicology Program), no mortalities, no clinical abnormalities, and no gross pathological findings were observed at exposure concentrations up to and including 660 mg/m³ (NTP 2011). In mice, transitional epithelial eosinophilic granules were observed in the urinary bladder of all exposed groups (dose-related), the toxicological significance of this finding is however unclear. In female mice, a NOAEC of 41.2 mg/m³ was established based on uterus atrophy found at 82.4 mg/m³, and atrophy of the ovary at 330 mg/m³. The NOAEC for nasal lesions in rats was 82.4 mg/m³ in males and 41.2 mg/m3 in females, and 164.8 mg/m3 in mice (NTP 2011). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4201b97d-69db-484e-a400-75af9721535f/documents/IUC5-ec45ee9a-789b-4156-acce-ee48dcb05150_fb9ebe91-9f98-444f-a3f6-7c7b63e40397.html,,,,,, "1,2,3,4-tetrahydronaphthalene",119-64-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4201b97d-69db-484e-a400-75af9721535f/documents/IUC5-ec45ee9a-789b-4156-acce-ee48dcb05150_fb9ebe91-9f98-444f-a3f6-7c7b63e40397.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "1,2,3,4-tetrahydronaphthalene",119-64-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4201b97d-69db-484e-a400-75af9721535f/documents/IUC5-ec45ee9a-789b-4156-acce-ee48dcb05150_fb9ebe91-9f98-444f-a3f6-7c7b63e40397.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,41.2 mg/m3,,rat "1,2,3,4-tetrahydronaphthalene",119-64-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4201b97d-69db-484e-a400-75af9721535f/documents/IUC5-ec45ee9a-789b-4156-acce-ee48dcb05150_fb9ebe91-9f98-444f-a3f6-7c7b63e40397.html,Repeated dose toxicity – local effects,inhalation,NOAEC,41.2 mg/m3,adverse effect observed,rat "1,2,3,4-tetrahydronaphthalene",119-64-2," The acute toxicity of 1,2,3,4-tetrahydronaphthalene was found to be relatively low with an oral LD50 of 2860 mg/kg bw in male rats (Carpenter, 1949), a dermal LD50 of 16800 mg/kg bw in male rabbits (Carpenter, 1949) and no mortalities within 8 hours inhalation of a saturated atmosphere (ca. 1800 mg/m³; male rats; Carpenter, 1949). In man, the chemical is known to produce headache, nausea, vomiting, lacrimation, green-gray urine, and restlessness at high concentrations (Koelsch, 1926). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4201b97d-69db-484e-a400-75af9721535f/documents/IUC5-96c9d7b5-81db-44c9-9646-0db6a14d2e45_fb9ebe91-9f98-444f-a3f6-7c7b63e40397.html,,,,,, "1,2,3,4-tetrahydronaphthalene",119-64-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4201b97d-69db-484e-a400-75af9721535f/documents/IUC5-96c9d7b5-81db-44c9-9646-0db6a14d2e45_fb9ebe91-9f98-444f-a3f6-7c7b63e40397.html,,oral,LD50,"2,860 mg/kg bw",no adverse effect observed, "1,2,3,4-tetrahydronaphthalene",119-64-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4201b97d-69db-484e-a400-75af9721535f/documents/IUC5-96c9d7b5-81db-44c9-9646-0db6a14d2e45_fb9ebe91-9f98-444f-a3f6-7c7b63e40397.html,,dermal,LD50,"16,800 mg/kg bw",no adverse effect observed, "1,2,3,4-tetrahydronaphthalene",119-64-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4201b97d-69db-484e-a400-75af9721535f/documents/IUC5-96c9d7b5-81db-44c9-9646-0db6a14d2e45_fb9ebe91-9f98-444f-a3f6-7c7b63e40397.html,,inhalation,LC50,"1,800 mg/m3",no adverse effect observed, "1,2,3,6-tetrahydro-3-methylphthalic anhydride",5333-84-6,"Oral:A NOAEL of 100 mg/kg bw/day was determined in a combined repeated dose/reproduction toxicity study (OECD 422) in rats on methyltetrahydrophthalic anhydride (THPA), this based on changes in clinical chemistry parameters, changes in organ weights and inflammation of the forestomach mucosa.Dermal and inhalation:In accordance with REACH Regulation 1907/2006 (Annex IX, Column 2), assessment of repeated dose toxicity by dermal or inhalation exposure is not required as data are available for the (default) the oral route. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/50f6b740-b8c0-4576-86b5-513b1b1656e8/documents/487e23af-302f-47a3-b8f4-25633436045b_69bdb290-91db-4968-bb80-5a1e0ec76294.html,,,,,, "1,2,3,6-tetrahydro-3-methylphthalic anhydride",5333-84-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/50f6b740-b8c0-4576-86b5-513b1b1656e8/documents/487e23af-302f-47a3-b8f4-25633436045b_69bdb290-91db-4968-bb80-5a1e0ec76294.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1,2,3,6-tetrahydro-3-methylphthalic anhydride",5333-84-6,Acute toxicity - Oral: LD50 - >2000 mg/kg - Dermal: LD50 - > 2000 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50f6b740-b8c0-4576-86b5-513b1b1656e8/documents/6a2d4c2a-314f-4a0e-828c-d404d3fdaf42_69bdb290-91db-4968-bb80-5a1e0ec76294.html,,,,,, "1,2,3,6-tetrahydro-3-methylphthalic anhydride",5333-84-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50f6b740-b8c0-4576-86b5-513b1b1656e8/documents/6a2d4c2a-314f-4a0e-828c-d404d3fdaf42_69bdb290-91db-4968-bb80-5a1e0ec76294.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,2,3,6-tetrahydro-3-methylphthalic anhydride",5333-84-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50f6b740-b8c0-4576-86b5-513b1b1656e8/documents/6a2d4c2a-314f-4a0e-828c-d404d3fdaf42_69bdb290-91db-4968-bb80-5a1e0ec76294.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,2,3,6-tetrahydro-4-methylphthalic anhydride",3425-89-6,Acute toxicity - Oral: LD50 - >2000 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/875d1a07-b106-4e08-911e-1fc806ee765d/documents/IUC5-0bc31ac7-d423-471f-a72c-288545c5d6b7_62a51ee5-dcb7-49a1-b720-4b0f7e7babbc.html,,,,,, "1,2,3,6-tetrahydro-4-methylphthalic anhydride",3425-89-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/875d1a07-b106-4e08-911e-1fc806ee765d/documents/IUC5-0bc31ac7-d423-471f-a72c-288545c5d6b7_62a51ee5-dcb7-49a1-b720-4b0f7e7babbc.html,,oral,LD50,"2,000 mg/kg bw",, "1,2,3,6-tetrahydromethyl-3,6-methanophthalic anhydride",25134-21-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b08e4c3-a3d5-4ca2-9455-394ad06ed897/documents/IUC5-2668352a-353f-4fc2-9267-1465f0613c60_8df0629b-f383-472e-8290-ae861e094604.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "1,2,3,6-tetrahydromethyl-3,6-methanophthalic anhydride",25134-21-8,Acute toxicity - Oral LD50: 1300mg/kg; Inhalation: LC50 < 0.75 mg/L; Dermal LD50: 4920mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b08e4c3-a3d5-4ca2-9455-394ad06ed897/documents/IUC5-27717830-0163-4fe8-afdd-3f111d5e3ff3_8df0629b-f383-472e-8290-ae861e094604.html,,,,,, "1,2,3,6-tetrahydromethyl-3,6-methanophthalic anhydride",25134-21-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b08e4c3-a3d5-4ca2-9455-394ad06ed897/documents/IUC5-27717830-0163-4fe8-afdd-3f111d5e3ff3_8df0629b-f383-472e-8290-ae861e094604.html,,oral,LD50,"1,300 mg/kg bw",adverse effect observed, "1,2,3,6-tetrahydromethyl-3,6-methanophthalic anhydride",25134-21-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b08e4c3-a3d5-4ca2-9455-394ad06ed897/documents/IUC5-27717830-0163-4fe8-afdd-3f111d5e3ff3_8df0629b-f383-472e-8290-ae861e094604.html,,dermal,LD50,"4,920 mg/kg bw",adverse effect observed, "1,2,3,6-tetrahydromethyl-3,6-methanophthalic anhydride",25134-21-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b08e4c3-a3d5-4ca2-9455-394ad06ed897/documents/IUC5-27717830-0163-4fe8-afdd-3f111d5e3ff3_8df0629b-f383-472e-8290-ae861e094604.html,,inhalation,discriminating conc.,750 mg/m3,adverse effect observed, "1,2,3,6-tetrahydrophthalic anhydride",85-43-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb1a6016-662f-4a90-9083-4c7eecf062b2/documents/IUC5-109a723c-935f-49de-82f0-11eb0cf7516c_ccc893d5-20f4-40a0-b2d8-f42425a9afc5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1,2,3,6-tetrahydrophthalic anhydride",85-43-8,Acute toxicity:Oral - LD50 - ca. 3200 mg/kgDermal - LD50 - > 2000 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb1a6016-662f-4a90-9083-4c7eecf062b2/documents/IUC5-44ef52dd-36de-41d7-bda5-a8382edd9456_ccc893d5-20f4-40a0-b2d8-f42425a9afc5.html,,,,,, "1,2,3,6-tetrahydrophthalic anhydride",85-43-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb1a6016-662f-4a90-9083-4c7eecf062b2/documents/IUC5-44ef52dd-36de-41d7-bda5-a8382edd9456_ccc893d5-20f4-40a0-b2d8-f42425a9afc5.html,,oral,LD50,"5,410 mg/kg bw",, "1,2,3,6-tetrahydrophthalic anhydride",85-43-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb1a6016-662f-4a90-9083-4c7eecf062b2/documents/IUC5-44ef52dd-36de-41d7-bda5-a8382edd9456_ccc893d5-20f4-40a0-b2d8-f42425a9afc5.html,,dermal,LD50,"2,000 mg/kg bw",, "1,2,3,6-tetrahydrophthalimide",85-40-5,- Acute toxicity:Oral: LD50: > 5000 mg/kg for rat (limit test). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/152d244e-ed1e-4d4e-bb33-c3ca38b6eff0/documents/IUC5-3f3633b7-b21e-4ea3-a53a-b0d2113845a5_8228e12c-9104-4176-8cad-bd69c892f5b5.html,,,,,, "1,2,3,6-tetrahydrophthalimide",85-40-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/152d244e-ed1e-4d4e-bb33-c3ca38b6eff0/documents/IUC5-3f3633b7-b21e-4ea3-a53a-b0d2113845a5_8228e12c-9104-4176-8cad-bd69c892f5b5.html,,oral,LD50,"5,000 mg/kg bw",, "1,2,3-Propanetricarboxylic acid, 2-hydroxy-, chromium (3+) salt",685853-81-0," Regardless of the high Cr3+ doses, chromium(III) oxide did not cause any significant treatment-related changes in the general condition of animals, body weights, clinical biochemistry, haematology, or pathological examination. Citric acid and associated salts are found in many foods and are formed in cells as a metabolite from glycolysis. There is no toxicity theshold for repeated exposure in humans, although acute toxic effects have been reported in animals. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e8628de-8541-471e-a6d5-a2a15190b301/documents/fcc7e67b-b25b-4ba3-906f-3d30f64668b4_8dafe112-07ae-425f-adb0-af7bbd5a1b00.html,,,,,, "1,2,3-Propanetricarboxylic acid, 2-hydroxy-, chromium (3+) salt",685853-81-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e8628de-8541-471e-a6d5-a2a15190b301/documents/fcc7e67b-b25b-4ba3-906f-3d30f64668b4_8dafe112-07ae-425f-adb0-af7bbd5a1b00.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat "1,2,3-Propanetricarboxylic acid, 2-hydroxy-, chromium (3+) salt",685853-81-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e8628de-8541-471e-a6d5-a2a15190b301/documents/fcc7e67b-b25b-4ba3-906f-3d30f64668b4_8dafe112-07ae-425f-adb0-af7bbd5a1b00.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"44,000 mg/m3",,rat "1,2,3-Propanetricarboxylic acid, 2-hydroxy-, chromium (3+) salt",685853-81-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e8628de-8541-471e-a6d5-a2a15190b301/documents/fcc7e67b-b25b-4ba3-906f-3d30f64668b4_8dafe112-07ae-425f-adb0-af7bbd5a1b00.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"44,000 mg/m3",no adverse effect observed,rat "1,2,3-Propanetricarboxylic acid, 2-hydroxy-, chromium (3+) salt",685853-81-0," From extensive work on chromium III salts, there is no evidence of acute toxicity. Some corrosive salts will cause harm at high concentrations, but this is not considered to be a toxic effect.   Critic acid is not classified; although some reports on anhydrous citric acid suggest Harmful (considered due to local irritation / corrosion of the anhydrous acid)   In view of the wealth of data on chromium salts and citric acid, no further animal testing is justified. It is accepted that there is no dermal absorption of metal salts such as chromium III from dermal contact.   The low oral toxicity also suggests low biological impact from contact with chromium III.  It is not considered to be justified to perform further animal tests. Skin penetration experiments on chromium chloride and chromium sulfate (1.2% chromium labelled with 51Cr) with skin chambers glued to the skin of normal volunteers. These chambers were removed at 6, 12, or 24 hours and analysis for radioactive chromium was performed at the site of the chamber as well as in the underlying epidermis and dermis. As no label was found in the lower levels of skin, it was concluded that chromium(III) salts did not permeate through the intact epidermis. Some blood samples and 24-h urine were also examined, and no radioactive chromium was detected.[Mali JWH, Van Kooten WJ, Van Neer CJ (1963) Some aspects of the behaviour of chromium compounds in the skin. Journal of Investigative Dermatology, 41:111–122]. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e8628de-8541-471e-a6d5-a2a15190b301/documents/2bce71e3-9aad-4724-8153-a2f02db78258_8dafe112-07ae-425f-adb0-af7bbd5a1b00.html,,,,,, "Reaction mass of 2,3-dihydroxypropyl formate and 1,3-dihydroxypropan-2-yl formate and 1-(formyloxy)-3-hydroxypropyl formate and 3-(formyloxy)-2-hydroxypropyl formate",1410795-90-2,"Test results for oral and inhalation exposure to formic acid and glycerol (degradation products of 1,2,3-propanetriol, mono- and diformates) are available. Based on respiratory injuries reported in the 90d inhalation study, local long-term effects are used for the risk assessment (section 7). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73ce9846-3fd6-4d38-866d-4f7acc0797ea/documents/IUC5-601bf9cb-11be-4f87-93d7-c6ba908d0d4a_ecabb086-2892-448f-af39-1bd847ac9683.html,,,,,, "Reaction mass of 2,3-dihydroxypropyl formate and 1,3-dihydroxypropan-2-yl formate and 1-(formyloxy)-3-hydroxypropyl formate and 3-(formyloxy)-2-hydroxypropyl formate",1410795-90-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73ce9846-3fd6-4d38-866d-4f7acc0797ea/documents/IUC5-601bf9cb-11be-4f87-93d7-c6ba908d0d4a_ecabb086-2892-448f-af39-1bd847ac9683.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"18,000 mg/kg bw/day",,pig "Reaction mass of 2,3-dihydroxypropyl formate and 1,3-dihydroxypropan-2-yl formate and 1-(formyloxy)-3-hydroxypropyl formate and 3-(formyloxy)-2-hydroxypropyl formate",1410795-90-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73ce9846-3fd6-4d38-866d-4f7acc0797ea/documents/IUC5-601bf9cb-11be-4f87-93d7-c6ba908d0d4a_ecabb086-2892-448f-af39-1bd847ac9683.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,244 mg/m3,,rat "Reaction mass of 2,3-dihydroxypropyl formate and 1,3-dihydroxypropan-2-yl formate and 1-(formyloxy)-3-hydroxypropyl formate and 3-(formyloxy)-2-hydroxypropyl formate",1410795-90-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73ce9846-3fd6-4d38-866d-4f7acc0797ea/documents/IUC5-601bf9cb-11be-4f87-93d7-c6ba908d0d4a_ecabb086-2892-448f-af39-1bd847ac9683.html,Repeated dose toxicity – local effects,inhalation,NOAEC,61 mg/m3,adverse effect observed,rat "Reaction mass of 2,3-dihydroxypropyl formate and 1,3-dihydroxypropan-2-yl formate and 1-(formyloxy)-3-hydroxypropyl formate and 3-(formyloxy)-2-hydroxypropyl formate",1410795-90-2,"Oral: LD50 (guinea pig, m/f) = 390 mg/kg bw (lowest dose descriptor available) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73ce9846-3fd6-4d38-866d-4f7acc0797ea/documents/IUC5-19314c95-e365-4572-8905-29d8e6e8858f_ecabb086-2892-448f-af39-1bd847ac9683.html,,,,,, "Reaction mass of 2,3-dihydroxypropyl formate and 1,3-dihydroxypropan-2-yl formate and 1-(formyloxy)-3-hydroxypropyl formate and 3-(formyloxy)-2-hydroxypropyl formate",1410795-90-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73ce9846-3fd6-4d38-866d-4f7acc0797ea/documents/IUC5-19314c95-e365-4572-8905-29d8e6e8858f_ecabb086-2892-448f-af39-1bd847ac9683.html,,oral,LD50,390 mg/kg bw,adverse effect observed, "1,2,3-propanetriyl tris[12-(acetoxy)octadecanoate]",139-43-5," Key information has been conducted according to recognised testing guidelines, prior to the adoption of the OECD principles of GLP in 1992. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/932371c7-fbee-4101-9e60-ce2b52850362/documents/e341b421-06ee-465a-9ade-7a24b5ae01b0_9a666eeb-62b5-44b7-9778-4c247008f208.html,,,,,, "1,2,3-tris(2,3-epoxypropoxy)propane",13236-02-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49ebf700-ae17-484c-88fa-672406973420/documents/2b7a6db5-6218-405c-b883-3f07efb349c5_0d532e0f-a19d-47e2-a4ce-69a1a1fd4ab6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,350 mg/kg bw/day,,rat "1,2,3-tris(2,3-epoxypropoxy)propane",13236-02-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49ebf700-ae17-484c-88fa-672406973420/documents/f8788af8-9b5e-4e41-b7e1-ab2cfad3956b_0d532e0f-a19d-47e2-a4ce-69a1a1fd4ab6.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, "1,2,3-tris(2,3-epoxypropoxy)propane",13236-02-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49ebf700-ae17-484c-88fa-672406973420/documents/f8788af8-9b5e-4e41-b7e1-ab2cfad3956b_0d532e0f-a19d-47e2-a4ce-69a1a1fd4ab6.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "tris(mixed dodecyl and octyl)benzene-1,2,4-tricarboxylate",1163775-81-2,"In a subchronic OECD 408 study, groups of male and female Sprague Dawley rats were dosed with 0, 60, 250 or 1000 mg/kg/day TM812 (1,2,4-Benzenetricarboxylic acid, mixed dodecyl and octyl triesters) in corn oil using a dose volume of 10mL/kg for a period of 90 days. Additional satellite group of recovery animals were included to understand the post-exposure recovery period in control and Group 4 (1000 mg/kg/day) animals. Reduce body weight gain was observed in males and female at 1000 mg/kg/day and additionally in females at 250 mg/kg/day.  However, during the recovery period, the body weight gains of the animals in dose group 1000 mg/kg bw/day recovered to normal.  There was no effect on food consumption during the study.  Mortality was observed in 3 male animals in low, mid and high dose groups which two were attributed to gavage errors.  The cause of death for the other animal remained unknown. There were no changes in ophthalmic examinations, no change to nerve function, no hematological and no urinalysis changes. Clinical chemistry changes were limited to an increase in liver enzymes ALP, ALT, AST and cholesterol with a decrease in total protein, albumin, globulin and T-Bilirubin in 1000 mg/kg bw males.  Potassium concentration was increased in males dosed with 1000 mg/kg and globulin values were decreased females in 1000 mg/kg dose group. The above changes were recovered to normal after stop of dosing withing the four weeks' recovery period.  The results of the coagulation parameter's analysis indicated that the test item at the dose of 1000 mg/kg had decreased fibrinogen in the males, but the animals recovered after stop of dosing within the four weeks's recovery period. There were no test item-related toxicity in organ weights, gross and macro or microscopic changes The NOEL was considered to be 250 mg/kg bw for the males and 60 mg/kg bw for the females. There was no significantly delayed occurrence of toxic effects during the four weeks recovery period. Under the conditions of the study, there were no toxicity pathology changes in Sprague Dawley rats with the test item.  The no-observed-adverse-effect-level (NOAEL) is therefore considered to be 1000 mg/kg bw. The subchronic oral toxicity of 1,2,4-Benzenetricarboxylic acid, decyl octyl ester was investigated in a well-conducted study in Sprague Dawley rats after daily oral administration at dose levels of 50, 200 and 500 mg/kg/day for 13 weeks and recovery from any treatment-related effects during a recovery period of 4 weeks. Signs of treatment-related effects of the test item were observed in males and females dosed at 200 and 500 mg/kg/day. These effects included some changes in clinical pathology parameters and some post mortem findings. The liver was identified as the main target organ on the basis of the organ weight data and histopathological findings. However, these changes were mild and fully reversible. The morphological aspect of the hepatocytic hypertrophy was consistent with proliferation of endoplasmic reticulum. As such, the hepatic effects were not considered to be adverse. No significant changes were observed in the animals dosed at 50 mg/kg/day. It can be concluded that the No Observed Adverse Effect Level (NOAEL) for this study was 500 mg/kg/day. In a subacute 28-day oral toxicity study in rats some treatment-related effects were evident in males and to a minor extent in females at the high dose level of 1000 mg/kg/d. The adrenals were identified as the main target organs, based on the post-mortem examination. The observed effects were completely reversible over a 2-week recovery period in the high dose animals. Only mild effects were observed in the animals (essentially males) dosed at 300 mg/kg/d, therefore this dose is expected to be NOAEL. No effects were observed at the low dose level (NOEL = 100 mg/kg/d). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0fb2f80e-e1aa-47d1-8ac0-cf9a7932610f/documents/IUC5-7842a536-61e5-4cb5-b046-866115078833_85863835-898e-4a2a-8349-e78032f6d808.html,,,,,, "tris(mixed dodecyl and octyl)benzene-1,2,4-tricarboxylate",1163775-81-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0fb2f80e-e1aa-47d1-8ac0-cf9a7932610f/documents/IUC5-7842a536-61e5-4cb5-b046-866115078833_85863835-898e-4a2a-8349-e78032f6d808.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "tris(mixed dodecyl and octyl)benzene-1,2,4-tricarboxylate",1163775-81-2," The acute oral and dermal toxicity of 1,2,4 -benzenetricarboxylic acid, mixed dodecyl and octyl triesters has been determined in two OECD 423 and an OECD 402 study. The oral and dermal LD50 were determined as > 2000 mg/kg bw. An additional OECD 403 inhalation study conducted at the maxiumum attainable concentration determined the LC50 >2.24 mg/L. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fb2f80e-e1aa-47d1-8ac0-cf9a7932610f/documents/IUC5-2556d5f8-361e-4710-bf75-2e3171954f0a_85863835-898e-4a2a-8349-e78032f6d808.html,,,,,, "tris(mixed dodecyl and octyl)benzene-1,2,4-tricarboxylate",1163775-81-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fb2f80e-e1aa-47d1-8ac0-cf9a7932610f/documents/IUC5-2556d5f8-361e-4710-bf75-2e3171954f0a_85863835-898e-4a2a-8349-e78032f6d808.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "tris(mixed dodecyl and octyl)benzene-1,2,4-tricarboxylate",1163775-81-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fb2f80e-e1aa-47d1-8ac0-cf9a7932610f/documents/IUC5-2556d5f8-361e-4710-bf75-2e3171954f0a_85863835-898e-4a2a-8349-e78032f6d808.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "tris(mixed dodecyl and octyl)benzene-1,2,4-tricarboxylate",1163775-81-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fb2f80e-e1aa-47d1-8ac0-cf9a7932610f/documents/IUC5-2556d5f8-361e-4710-bf75-2e3171954f0a_85863835-898e-4a2a-8349-e78032f6d808.html,,inhalation,LC50,> 2.24 mg/L,no adverse effect observed, "1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters",94279-36-4,"- 90-day, oral, rat (OECD 408): NOAEL >= 1000 mg/kg bw/day (m/f)  The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No. 1907/2006. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c356701-35cd-4586-9721-9dee2a0e6c6a/documents/22fa7b2b-d6f7-4a65-acab-c1fcd6b5f1b2_f48d3b4c-d49c-4fb1-aca5-1387960a8cf3.html,,,,,, "1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters",94279-36-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c356701-35cd-4586-9721-9dee2a0e6c6a/documents/22fa7b2b-d6f7-4a65-acab-c1fcd6b5f1b2_f48d3b4c-d49c-4fb1-aca5-1387960a8cf3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters",94279-36-4,"- acute oral (OECD 401): LD50 > 2000 mg/kg bw (male / female rats)  The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No. 1907/2006. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c356701-35cd-4586-9721-9dee2a0e6c6a/documents/9dbbfeff-b27d-4a2d-9c52-df160a6772b7_f48d3b4c-d49c-4fb1-aca5-1387960a8cf3.html,,,,,, "1,2,4-Benzenetricarboxylic acid, tri-C9-11-alkyl esters",94279-36-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c356701-35cd-4586-9721-9dee2a0e6c6a/documents/9dbbfeff-b27d-4a2d-9c52-df160a6772b7_f48d3b4c-d49c-4fb1-aca5-1387960a8cf3.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1,2,4-triazole-3-thiol",3179-31-5," 3 -Mercapto-1,2,4 -triazole was administered one-time orally to rats to determine its acute toxicity. The test product was present as a crystalline substance and was applied in an aqueous tragacanth suspension (0.5%).Using application volumes of 4.64 and 10.0 ml / kg with test substance contents of 215 to 464 mg / ml, the dosis in the male and female animals ranged from 1000 to 4640 mg / kg. The intoxication was characterized by tremor, clonic convulsions, loss of muscle tone, generalized reflex failure, diarrhea and poor general condition. Occasionally, stilt walk, ruffled fur, sunken flanks and red-colored tears flow and strenuous breathing were observed. Initial symptoms of poisoning occurred 1 hour after substance administration and lasted up to 5 days. Deaths occurred between 2 hours and 5 days p.appl. A dose of 1000 mg / kg caused no signs of intoxication in female rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b44a71c-619e-4b1e-9611-027e1dadc187/documents/2c9180da-6ccd-4a1b-a7b3-91221e57926a_dc859e89-b147-4ad8-8478-d305e9aad298.html,,,,,, "1,2,4-triazole-3-thiol",3179-31-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b44a71c-619e-4b1e-9611-027e1dadc187/documents/2c9180da-6ccd-4a1b-a7b3-91221e57926a_dc859e89-b147-4ad8-8478-d305e9aad298.html,,oral,LD50,"1,297 mg/kg bw",adverse effect observed, "1,2,4-trichlorobenzene",120-82-1,"- Acute toxicity Oral: Combined LD50 (rats) = 930 mg/kg bw (OECD 401 / non-GLP / K2) (Bayer, 1982). - Acute toxicity: Dermal: LD50 (rats) > 5000 mg/kg bw (EU RAR 2003). - Acute toxicity: Inhalation: no relevant study available. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): One key study available (Bayer, 1982), comparable to guideline study. Other available data report similar LD50, all within the CLP Category 4 range. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): No key study identified, but the rabbit study reported in the EU RAR showed a LD50 > 5000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b44e5ba6-bf4a-4b5d-b735-f952108dfadf/documents/6fc42e51-41ec-410e-8ca0-696cc9260610_3c3ae65d-85ee-4fc2-aad0-8d0e33026b79.html,,,,,, "1,2,4-trichlorobenzene",120-82-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b44e5ba6-bf4a-4b5d-b735-f952108dfadf/documents/6fc42e51-41ec-410e-8ca0-696cc9260610_3c3ae65d-85ee-4fc2-aad0-8d0e33026b79.html,,oral,LD50,930 ,adverse effect observed, "1,2,4-trichlorobenzene",120-82-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b44e5ba6-bf4a-4b5d-b735-f952108dfadf/documents/6fc42e51-41ec-410e-8ca0-696cc9260610_3c3ae65d-85ee-4fc2-aad0-8d0e33026b79.html,,dermal,LD50,">=5,000 mg/kg bw",no adverse effect observed, "1,2-Diaminotoluene, propoxylated",1228577-90-9,28-day oral (gavage) NOAEL for both sexes was concluded as 40 mg/kg b.w./d ( based on nominal) based on histopathological changes in the liver and thyroids. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39486e75-5b99-4016-b5d8-cbcd8d494209/documents/IUC5-99603022-a8e2-4be4-aa0f-0b63b0cb3358_0c75bf6c-5967-4786-ba65-8e44e6ab0e43.html,,,,,, "1,2-Diaminotoluene, propoxylated",1228577-90-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39486e75-5b99-4016-b5d8-cbcd8d494209/documents/IUC5-99603022-a8e2-4be4-aa0f-0b63b0cb3358_0c75bf6c-5967-4786-ba65-8e44e6ab0e43.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,, "1,2-Diaminotoluene, propoxylated",1228577-90-9,Acute toxicity via oral route LD50 of > 2500 mg/kg bw was determined following the acute LD50 Class method (highest does tested 2000 mg/kg bw).Acute toxicity via dermal route LD50 was determined to be greater than 2000 mg/kg body weight. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39486e75-5b99-4016-b5d8-cbcd8d494209/documents/IUC5-49efeb40-b066-47e9-b756-6dda859388ac_0c75bf6c-5967-4786-ba65-8e44e6ab0e43.html,,,,,, "1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich",68515-47-9,"The target organ for oral sub-acute and sub-chronic DIDP toxicity in animals (rodent and dog) appears to be the liver (increased liver weights and significant changes in liver peroxisomal enzyme activities in rodents). It is clear that NOAELs derived from rat studies are related to peroxisome proliferation-mediated liver effects, which are considered to be species specific. Humans are less sensitive than rats. The overall NOAEL for systemic effects following oral exposure in rats was 150 mg/kg/d. In a six-week dermal study with DINP, there was no evidence of systemic toxicity. Mild irritation was observed at the application sites of animals treated with DINP, although there was no difference in the severity of histopathological skin changes apparent between test and control animals. The systemic NOEL was considered to be 2.5 ml/kg/day (estimated to be 2500 mg/kg/day) and the local NOAEL was considered to be 0.5 mg/kg/day (estimated to be 500 mg/kg/day). In a two week inhalation study with DIDP, no systemic toxicity was observed, but local irritant effects were observed at the concentration tested, thus a NOAEL of 0.5 mg/l (500 mg/m3) can be assumed. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0465057-8594-4351-aefc-3422fdd0625f/documents/IUC5-21f10a1f-0d5c-4971-9cac-942537cf4692_7e209e68-3b7e-4006-b8a2-258497654b57.html,,,,,, "1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich",68515-47-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0465057-8594-4351-aefc-3422fdd0625f/documents/IUC5-21f10a1f-0d5c-4971-9cac-942537cf4692_7e209e68-3b7e-4006-b8a2-258497654b57.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,, "1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich",68515-47-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0465057-8594-4351-aefc-3422fdd0625f/documents/IUC5-21f10a1f-0d5c-4971-9cac-942537cf4692_7e209e68-3b7e-4006-b8a2-258497654b57.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,, "1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich",68515-47-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0465057-8594-4351-aefc-3422fdd0625f/documents/IUC5-21f10a1f-0d5c-4971-9cac-942537cf4692_7e209e68-3b7e-4006-b8a2-258497654b57.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,500 mg/m3,, "1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich",68515-47-9,Minimally Toxic. Based on test data for the material. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0465057-8594-4351-aefc-3422fdd0625f/documents/IUC5-a7d0bce0-35ba-4c37-ba3f-27fa1cec36dc_7e209e68-3b7e-4006-b8a2-258497654b57.html,,,,,, "1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich",68515-47-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0465057-8594-4351-aefc-3422fdd0625f/documents/IUC5-a7d0bce0-35ba-4c37-ba3f-27fa1cec36dc_7e209e68-3b7e-4006-b8a2-258497654b57.html,,oral,LD50,"10,000 mg/kg bw",, "1,2-Benzenedicarboxylic acid, di-C11-14-branched alkyl esters, C13-rich",68515-47-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0465057-8594-4351-aefc-3422fdd0625f/documents/IUC5-a7d0bce0-35ba-4c37-ba3f-27fa1cec36dc_7e209e68-3b7e-4006-b8a2-258497654b57.html,,dermal,LD50,"3,160 mg/kg bw",, "1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters",68515-51-5,Sub-chronic toxicity; oral: NOAEL - Males - 79.6 mg/kg/day; Females - 303.9 mg/kg/day (based on read-across) ,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f7a84dc2-b13a-4439-8a64-57f35d88bcae/documents/IUC5-a2b1a493-4271-4f92-ac72-b2fce12bf630_ae29f5b2-d25f-4fed-a1ef-0fcf59724c7e.html,,,,,, "1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters",68515-51-5,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f7a84dc2-b13a-4439-8a64-57f35d88bcae/documents/IUC5-a2b1a493-4271-4f92-ac72-b2fce12bf630_ae29f5b2-d25f-4fed-a1ef-0fcf59724c7e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,79.6 mg/kg bw/day,,rat "1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters",68515-51-5,"The toxicity of the substance is low after oral or dermal exposure, or exposure via inhalation. oral LD50 > 2000 mg/kg inhalative LC50 > 1.8 mg/L (strucutrally related phthalate) dermal LD50 > 2000 mg/kg ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7a84dc2-b13a-4439-8a64-57f35d88bcae/documents/IUC5-a3002a4f-1ba3-4412-9fea-0929624e1fd0_ae29f5b2-d25f-4fed-a1ef-0fcf59724c7e.html,,,,,, "1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters",68515-51-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7a84dc2-b13a-4439-8a64-57f35d88bcae/documents/IUC5-a3002a4f-1ba3-4412-9fea-0929624e1fd0_ae29f5b2-d25f-4fed-a1ef-0fcf59724c7e.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,2-Benzenedicarboxylic acid, di-C6-10-alkyl esters",68515-51-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7a84dc2-b13a-4439-8a64-57f35d88bcae/documents/IUC5-a3002a4f-1ba3-4412-9fea-0929624e1fd0_ae29f5b2-d25f-4fed-a1ef-0fcf59724c7e.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters",71662-46-9,Sub-chronic toxicity; oral: NOAEL - Males - 79.6 mg/kg/day; Females - 303.9 mg/kg/day ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c15e5c0-cc25-4678-94e8-3781ea45c84e/documents/IUC5-a9cddcdb-8b46-46b7-95a2-82ea344762d5_1b5bfd1f-36d8-482a-ba03-bf5ae1cf86c0.html,,,,,, "1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters",71662-46-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c15e5c0-cc25-4678-94e8-3781ea45c84e/documents/IUC5-a9cddcdb-8b46-46b7-95a2-82ea344762d5_1b5bfd1f-36d8-482a-ba03-bf5ae1cf86c0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,79.6 mg/kg bw/day,,rat "1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters",71662-46-9, The toxicity of the substance is low after oral exposure. Also the toxicity after exposure via inhalation and dermal is expected to be low. oral LD50 > 2000 mg/kg (test substance) inhalative waiving dermal waiving: The study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route. Additionally studies on similar substances resulted in a dermal LD50 of > 2000 mg/kg. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c15e5c0-cc25-4678-94e8-3781ea45c84e/documents/IUC5-f1297269-714a-498e-b55c-7349beca48a3_1b5bfd1f-36d8-482a-ba03-bf5ae1cf86c0.html,,,,,, "1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters",71662-46-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c15e5c0-cc25-4678-94e8-3781ea45c84e/documents/IUC5-f1297269-714a-498e-b55c-7349beca48a3_1b5bfd1f-36d8-482a-ba03-bf5ae1cf86c0.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,2-Benzenedicarboxylic acid, di-C8-10-alkyl esters",71662-46-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c15e5c0-cc25-4678-94e8-3781ea45c84e/documents/IUC5-f1297269-714a-498e-b55c-7349beca48a3_1b5bfd1f-36d8-482a-ba03-bf5ae1cf86c0.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich",68515-49-1,"A series of oral sub-acute (21-day/rat-NOAEL 280 mg/kg/day; 28-day/rat-NOAEL 57 mg/kg/day) and sub-chronic repeated dose toxicity tests (90-day/Dog- NOAEL 75 mg/kg/day; 90-day/rat- 150 mg/kg/day) were conducted on DIDP. The target organ for oral sub-acute and sub-chronic DIDP toxicity in animals (rodent and dog) is the liver (increased liver weights and significant changes in liver peroxisomal enzyme activities in rodents). These effects were obtained in rat studies are related to peroxisome proliferation-mediated liver effects, which are considered to be species specific. Humans are less sensitive than rats. In a repeated dose toxicity study of limited reliability in dogs, which is considered a more relevant species to humans with respect to peroxisome proliferation, a LOAEL of 500 mg/kg bw/d was reported for increased liver weights and histological changes. The NOAEL was 75 mg/kg bw d. Current literature indicates that rodents compared to humans are particularly susceptible to peroxisome proliferative effects. In the light of peroxisome proliferative effects observed for DIDP, liver effects from DIDP exposure may not be relevant for humans. Therefore, the overall NOAEL for systemic effects following oral exposure in rats was 150 mg/kg bw/d. Liver enlargement was due to hepatocyte hypertrophy.  The major biochemical alterations consisted of induction of both peroxisomal (increased acyl-CoA oxidase) and microsomal (lauric acid 11- and 12-hydroxylases) fatty-acid-oxidizing activities. The former is considered to be a specific marker of peroxisome proliferation.  A sub-chronic (2-week, rat inhalation study set the NOAEC of 500 mg/m3), produced local irritation but no systemic toxicity in rats at the concentrations tested. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd52e6c0-1e0b-492f-8539-61093c7dc7a1/documents/IUC5-db46645d-089c-4555-ad2f-e1bfb9263f02_d9d5531d-078b-4583-bcd1-e6f4ce37497d.html,,,,,, "1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich",68515-49-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd52e6c0-1e0b-492f-8539-61093c7dc7a1/documents/IUC5-db46645d-089c-4555-ad2f-e1bfb9263f02_d9d5531d-078b-4583-bcd1-e6f4ce37497d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,, "1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich",68515-49-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd52e6c0-1e0b-492f-8539-61093c7dc7a1/documents/IUC5-db46645d-089c-4555-ad2f-e1bfb9263f02_d9d5531d-078b-4583-bcd1-e6f4ce37497d.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,500 mg/m3,, "1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich",68515-49-1,"In a series of LD50 studies reported by Smyth et al. (1962), the LD50 of DIDP in rats is above 62,080 mg/kg. In a 24-hour exposure dermal study (Hazleton Laboratories America, 1978) in rabbits (4 animals, sex not specified), a dose of 3,160 mg/kg was applied on abraded skin and remained in contact with the skin by means of a non-absorbent binding. There was no mortality during the 14-day test period. The dermal LD50 was therefore estimated to be greater than 3,160 mg/kg. (Industrial Bio-Test Laboratories, 1975) was conducted in rats, mice and Guinea pigs (5 males and 5 females) at 0.13 mg/l (nominal concentration). DIDP was reported to have been administered as a vapor, but regarding the test conditions the substance was probably administered as an aerosol. No deaths occurred, no adverse reactions were noticed following the 14-day observation period, and there were no gross tissue changes attributable to effects of the test The LC50 is >0.13 mg/l. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd52e6c0-1e0b-492f-8539-61093c7dc7a1/documents/IUC5-22e0a5a8-8c2e-4e2b-8e60-c9bb9f3451f7_d9d5531d-078b-4583-bcd1-e6f4ce37497d.html,,,,,, "1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich",68515-49-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd52e6c0-1e0b-492f-8539-61093c7dc7a1/documents/IUC5-22e0a5a8-8c2e-4e2b-8e60-c9bb9f3451f7_d9d5531d-078b-4583-bcd1-e6f4ce37497d.html,,oral,LD50,"62,080 mg/kg bw",, "1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich",68515-49-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd52e6c0-1e0b-492f-8539-61093c7dc7a1/documents/IUC5-22e0a5a8-8c2e-4e2b-8e60-c9bb9f3451f7_d9d5531d-078b-4583-bcd1-e6f4ce37497d.html,,dermal,LD50,"3,160 mg/kg bw",, "1,2-Benzenedicarboxylic acid, di-C9-11-branched alkyl esters, C10-rich",68515-49-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd52e6c0-1e0b-492f-8539-61093c7dc7a1/documents/IUC5-22e0a5a8-8c2e-4e2b-8e60-c9bb9f3451f7_d9d5531d-078b-4583-bcd1-e6f4ce37497d.html,,inhalation,LC50,130 mg/m3,, "1,2-Benzenedicarboxylic acid, di-C9-11-branched and linear alkyl esters",68515-43-5,Sub-chronic toxicity; oral: NOAEL - Males - 79.6 mg/kg/day; Females - 303.9 mg/kg/dayWhen corrected for differences in molecular weight between the read-across substance and the registed substance this results in an oral: NOAEL - Males - 87.9 mg/kg/day; Females - 335.5 mg/kg/day ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/437b5ccc-9984-4110-a64c-28b587faf406/documents/IUC5-c74b45f4-5656-40cd-ada8-653771cd264d_5b95cf04-3049-4aef-a91c-77d4c4fe8ed8.html,,,,,, "1,2-Benzenedicarboxylic acid, di-C9-11-branched and linear alkyl esters",68515-43-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/437b5ccc-9984-4110-a64c-28b587faf406/documents/IUC5-c74b45f4-5656-40cd-ada8-653771cd264d_5b95cf04-3049-4aef-a91c-77d4c4fe8ed8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,79.6 mg/kg bw/day,,rat "1,2-Benzenedicarboxylic acid, di-C9-11-branched and linear alkyl esters",68515-43-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/437b5ccc-9984-4110-a64c-28b587faf406/documents/IUC5-0b58b876-7954-4b03-98b6-dfc2a761e376_5b95cf04-3049-4aef-a91c-77d4c4fe8ed8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,2-Benzenedicarboxylic acid, di-C9-11-branched and linear alkyl esters",68515-43-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/437b5ccc-9984-4110-a64c-28b587faf406/documents/IUC5-0b58b876-7954-4b03-98b6-dfc2a761e376_5b95cf04-3049-4aef-a91c-77d4c4fe8ed8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,2-Benzenedicarboxylic acid, isodecyl ester, manuf. of, by-products from",68515-38-8,Acute Toxicity - Oral LD50 >2000 mg/kg for study substance in Wistar rat (OECD TG 420)Dermal Toxicity - Dermal LD50 >2000 mg/kg for study substance in Wistar rat (OECD TG 402) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29d519e2-68d9-4aae-b9d4-cf85a709a013/documents/16bb860f-43de-4167-81a4-6f7753a795d1_2de402e5-aee2-4b85-a89b-ee99710659d0.html,,,,,, "1,2-Benzenedicarboxylic acid, isononyl ester, manuf. of, by-products from",68515-37-7,Acute Toxicity - Oral LD50 >2000 mg/kg for study substance in Wistar rat (OECD TG 420) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/161ef00b-3317-435d-a678-b0ee76436bce/documents/16926a59-bd96-4ae3-9d25-d53d392c0a7b_f8883466-ceb8-47a4-89fb-2b34f6450b41.html,,,,,, "1,2-Benzenedicarboxylic acid, tridecyl ester, manuf. of, by-products from",68515-39-9,Acute Toxicity - Oral LD50 >2000 mg/kg for study substance in Wistar rat (OECD TG 420) Dermal Toxicity - Dermal LD50 >2000 mg/kg for study substance in Wistar rat (OECD TG 402) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4235c39e-7536-400a-b01c-4d4ce6ce1055/documents/a5c0a97b-68d1-43aa-9364-05af14b0dcb5_18b795d5-f28b-439d-bb68-a5b820b7338f.html,,,,,, "4-(4-methylbenzenesulfonyl)benzene-1,2-diol",107065-85-0," An OECD 422 study for a structural analogue showed no effects at the highest tested dose (750 mg/kg bw). Therefore, the NOAEL for CH04008 was set at 750 mg/kg. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d064bd8-438f-4bf6-814e-a0984acf63d5/documents/44a872a3-a28f-4fd8-82f5-55c786214944_d9601c81-e80d-4d20-ba14-04423307c15b.html,,,,,, "4-(4-methylbenzenesulfonyl)benzene-1,2-diol",107065-85-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d064bd8-438f-4bf6-814e-a0984acf63d5/documents/44a872a3-a28f-4fd8-82f5-55c786214944_d9601c81-e80d-4d20-ba14-04423307c15b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "4-(4-methylbenzenesulfonyl)benzene-1,2-diol",107065-85-0," For acute oral and dermal toxicity, guideline studies were available for a structural analogue (CH03951). Additionally, QSAR results are provided to further support the conclusions of the read-across. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d064bd8-438f-4bf6-814e-a0984acf63d5/documents/cef47fa4-42f1-4d19-8f79-0e5125e43032_d9601c81-e80d-4d20-ba14-04423307c15b.html,,,,,, "4-(4-methylbenzenesulfonyl)benzene-1,2-diol",107065-85-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d064bd8-438f-4bf6-814e-a0984acf63d5/documents/cef47fa4-42f1-4d19-8f79-0e5125e43032_d9601c81-e80d-4d20-ba14-04423307c15b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-(4-methylbenzenesulfonyl)benzene-1,2-diol",107065-85-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d064bd8-438f-4bf6-814e-a0984acf63d5/documents/cef47fa4-42f1-4d19-8f79-0e5125e43032_d9601c81-e80d-4d20-ba14-04423307c15b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-methyl-1,2-benzothiazole-1,1-dione",34989-82-7, In the acute oral toxicity study with rats a LD50 > 2000 mg/kg bw was determined. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9b9fb0e-6630-4078-a929-3dee387b39ce/documents/2ad69a48-c261-442a-9a1a-86640d9d7d35_73200265-e632-4d9a-9909-1600203829b1.html,,,,,, "3-methyl-1,2-benzothiazole-1,1-dione",34989-82-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9b9fb0e-6630-4078-a929-3dee387b39ce/documents/2ad69a48-c261-442a-9a1a-86640d9d7d35_73200265-e632-4d9a-9909-1600203829b1.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,2-bis(3-methylphenoxy)ethane",54914-85-1,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyInformation.KeyInformation): The oral repeated toxicity of 1,2-Bis(3-methylphenoxy)ethane was investigated in a 28 day feeding study according to OECD 207. A NOEL value of 20 mg/kg bw/day and a NOAEL value of 200 mg/kg bw/day were determined. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d14d6b04-bc0e-48d0-aaee-03919824722b/documents/fdb33461-16e0-40a9-826a-df2ec1043578_222cde1b-2383-4658-aa15-3e930c5ffba5.html,,,,,, "1,2-bis(3-methylphenoxy)ethane",54914-85-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d14d6b04-bc0e-48d0-aaee-03919824722b/documents/fdb33461-16e0-40a9-826a-df2ec1043578_222cde1b-2383-4658-aa15-3e930c5ffba5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "1,2-bis(3-methylphenoxy)ethane",54914-85-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d14d6b04-bc0e-48d0-aaee-03919824722b/documents/4995d52c-1ab8-4005-8387-4796382b93e1_222cde1b-2383-4658-aa15-3e930c5ffba5.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "1,2-bis(3-methylphenoxy)ethane",54914-85-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d14d6b04-bc0e-48d0-aaee-03919824722b/documents/4995d52c-1ab8-4005-8387-4796382b93e1_222cde1b-2383-4658-aa15-3e930c5ffba5.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1,2-bis(3-methylphenoxy)ethane",54914-85-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d14d6b04-bc0e-48d0-aaee-03919824722b/documents/4995d52c-1ab8-4005-8387-4796382b93e1_222cde1b-2383-4658-aa15-3e930c5ffba5.html,,inhalation,LC50,> 3 mg/L,no adverse effect observed, "1,2-diacetoxybut-3-ene",18085-02-4,Two studies are available to assess repeated dose toxicity via the oral route. ECHA has provided a 28-day repeated dose study to rats and a sub-chronic 90-day repeated dose study (OECD 408) was performed. No studies assessing inhalation or dermal exposure are available.   ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34616939-26e5-4482-9aef-f673e080f19f/documents/459a57ef-0f8a-4689-bd40-1ade552bcda8_0f81f243-06a1-4ab0-b61d-14836302648e.html,,,,,, "1,2-diacetoxybut-3-ene",18085-02-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34616939-26e5-4482-9aef-f673e080f19f/documents/459a57ef-0f8a-4689-bd40-1ade552bcda8_0f81f243-06a1-4ab0-b61d-14836302648e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,167 mg/kg bw/day,,rat "1,2-diacetoxybut-3-ene",18085-02-4, Data available includes an acute oral toxicity study provided by ECHA and an acute dermal toxicity study (conducted to OECD guidelines and GLP) as the relevant second exposure route. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34616939-26e5-4482-9aef-f673e080f19f/documents/c7fd8a15-055d-406b-a995-b33192d3b87a_0f81f243-06a1-4ab0-b61d-14836302648e.html,,,,,, "1,2-diacetoxybut-3-ene",18085-02-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34616939-26e5-4482-9aef-f673e080f19f/documents/c7fd8a15-055d-406b-a995-b33192d3b87a_0f81f243-06a1-4ab0-b61d-14836302648e.html,,oral,LD50,794 mg/kg bw,adverse effect observed, "1,2-diacetoxybut-3-ene",18085-02-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34616939-26e5-4482-9aef-f673e080f19f/documents/c7fd8a15-055d-406b-a995-b33192d3b87a_0f81f243-06a1-4ab0-b61d-14836302648e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane",2356-53-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14c44832-74de-4bb7-a81c-e297646c1641/documents/IUC5-775cbd4f-a2f1-41ee-b9bd-938b14d74a69_e7c541b4-9878-4ab8-bcce-a4f7e0c5c84c.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "1,2-dichloro-1,1,2-trifluoro-2-(trifluoromethoxy)ethane",2356-53-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14c44832-74de-4bb7-a81c-e297646c1641/documents/IUC5-775cbd4f-a2f1-41ee-b9bd-938b14d74a69_e7c541b4-9878-4ab8-bcce-a4f7e0c5c84c.html,,inhalation,LC50,> 21.98 mg/L,no adverse effect observed, "1,2-dichloro-3-nitrobenzene",3209-22-1,"In a repeated dose and reproductive/developmental toxicity Screening Test (OECD TG 422) 1,2-dichloro-3-nitrobenzene was administered (oral gavage) to male and female Crj:CD (SD) rats. The rats were treated with 0 (vehicle), 1, 5, 25 and 100 mg/kg bw/day test substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Acceptable, well-documented study publication which meets basic scientific principles. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f11642a-2923-4376-8ba4-f21435c62682/documents/88f4fdf3-9b46-486d-a784-8efe5b49f991_4a3e0874-9acc-43a6-a0ef-e471084913ac.html,,,,,, "1,2-dichloro-3-nitrobenzene",3209-22-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f11642a-2923-4376-8ba4-f21435c62682/documents/88f4fdf3-9b46-486d-a784-8efe5b49f991_4a3e0874-9acc-43a6-a0ef-e471084913ac.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "1,2-dichloro-3-nitrobenzene",3209-22-1,"The acute oral LD50 value in male rats is 1070 mg/kg (Löser 1980) and the dermal LD50 value in rats is greater than 2500 mg/kg bw (Löser 1981). No acute inhalation study is available. However, the acute oral toxicity study in cats demonstrate a methemoglobin formation. Therefore the classification for acute toxicity is increased. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Acceptable, well-documented study report which meets basic scientific principles. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Acceptable, well-documented study report which meets basic scientific principles. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f11642a-2923-4376-8ba4-f21435c62682/documents/02871015-a5ed-4481-8bc6-90975313a273_4a3e0874-9acc-43a6-a0ef-e471084913ac.html,,,,,, "1,2-dichloro-3-nitrobenzene",3209-22-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f11642a-2923-4376-8ba4-f21435c62682/documents/02871015-a5ed-4481-8bc6-90975313a273_4a3e0874-9acc-43a6-a0ef-e471084913ac.html,,oral,LD50,"1,070 mg/kg bw",adverse effect observed, "1,2-dichloro-3-nitrobenzene",3209-22-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f11642a-2923-4376-8ba4-f21435c62682/documents/02871015-a5ed-4481-8bc6-90975313a273_4a3e0874-9acc-43a6-a0ef-e471084913ac.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "1,2-dichloro-4-(trichloromethyl)benzene",13014-24-9, The LD50 in male rat is 1424 mg/kg bw. The LD50 in female rat is 1600 mg/kg bw. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cda392cf-e4af-4462-b49a-d1a313440778/documents/d9908c1d-fd64-4988-84fe-a1712387b205_d0561f96-32f7-4128-bb4c-e30067facc24.html,,,,,, "1,2-dichloro-4-(trichloromethyl)benzene",13014-24-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cda392cf-e4af-4462-b49a-d1a313440778/documents/d9908c1d-fd64-4988-84fe-a1712387b205_d0561f96-32f7-4128-bb4c-e30067facc24.html,,oral,LD50,"1,424 mg/kg bw",adverse effect observed, "1,2-dichloro-4-nitrobenzene",99-54-7,"In a study according to OECD Guideline 407 male and female Sprague-Dawley rats received 0, 4, 20, 100 mg/kg bw/d dissolved in sesame oil by gavage for 28 days. The NOAEL was 4 mg/kg bw/d based on changes in red blood cell parameters, on hemolytic anemia with microscopic changes in the spleen and increase in relative liver weights in the next higher dose and increase in relative spleen weight at 100 mg/kg bw/d (Hoechst AG 1993). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b96347a6-b56b-46fe-924f-27bb55ef3c3f/documents/IUC5-0f6b878e-998a-439d-9f35-3f83c47128ac_82b40406-03f0-4127-a974-8db5fe99fd01.html,,,,,, "1,2-dichloro-4-nitrobenzene",99-54-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b96347a6-b56b-46fe-924f-27bb55ef3c3f/documents/IUC5-0f6b878e-998a-439d-9f35-3f83c47128ac_82b40406-03f0-4127-a974-8db5fe99fd01.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,4 mg/kg bw/day,,rat "1,2-dichloro-4-nitrobenzene",99-54-7,"oral Single oral application of 1,2 -dichloro-4 -nitrobenzene to male rats resulted in LD50 of 625 mg/kg bw. Signs of intoxication were disorder in balance, reduced general condition and death in prone position (Hoechst AG 1975).  inhalationThere are no valid acute inhalation studies available. dermalSingle dermal application of 1,2 -Dichloronitrobenzene to the shaved, intact back of 6 female rats caused no mortality and no clinical findings. Thus the LD50 > 2000 mg/kg bw is determined (Hoechst AG 1975). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b96347a6-b56b-46fe-924f-27bb55ef3c3f/documents/IUC5-79c2b9f2-2d6d-4123-9164-b4e6c7707756_82b40406-03f0-4127-a974-8db5fe99fd01.html,,,,,, "1,2-dichloro-4-nitrobenzene",99-54-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b96347a6-b56b-46fe-924f-27bb55ef3c3f/documents/IUC5-79c2b9f2-2d6d-4123-9164-b4e6c7707756_82b40406-03f0-4127-a974-8db5fe99fd01.html,,oral,LD50,695 mg/kg bw,adverse effect observed, "1,2-dichloro-4-nitrobenzene",99-54-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b96347a6-b56b-46fe-924f-27bb55ef3c3f/documents/IUC5-79c2b9f2-2d6d-4123-9164-b4e6c7707756_82b40406-03f0-4127-a974-8db5fe99fd01.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,2-dichlorobenzene",95-50-1," No valid studies are available for inhalation and dermal repeated dose toxicity. For oral toxicity, we used a NOAEL of 60 mg/kg/day derived in an oral sub-chronic toxicity study as a starting point for DNEL calculation; since the NOAEL in the chronic studies are equal or higher than the NOAEL for sub-chronic toxicity studies the starting point for DNEL calculation should be considered conservative. The same overall oral NOAEL of 60 mg/kg bw/day was also reported in the OECD SIDS Report on 1,2-dichlorobenzene (2001). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e47bfcf7-6913-48b4-b4b7-0dc7ec9b07f0/documents/IUC5-d3327334-86e9-4345-9eaa-9702ebcbdd65_cfd3a2f2-f700-4d1a-a4ab-da49c377029e.html,,,,,, "1,2-dichlorobenzene",95-50-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e47bfcf7-6913-48b4-b4b7-0dc7ec9b07f0/documents/IUC5-d3327334-86e9-4345-9eaa-9702ebcbdd65_cfd3a2f2-f700-4d1a-a4ab-da49c377029e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat "1,2-dichlorobenzene",95-50-1,"ORAL EXPOSURE: A single dose oral toxicity study of 1,2-dichlorobenzene was conducted according to OECD guideline 401 (Nagata et al., 2001). The LD50 values were estimated to be greater than 2000 mg/kg for males and females. Older studies found lower LD50 values. According to the harmonised classification - Annex VI of Regulation (EC) No 1272/2008 (CLP regulation) 1,2-dichlorobenzene is classified as Acute Tox. 4* (H302: Harmful if swallowed). INHALATIVE EXPOSURE There are several limited acute inhalation toxicity studies available. Based on a weight-of-evidence approach and according to CLP classification criteria (Regulation (EC) No 1272/2008) a classification as Acute Tox 4 ( H332: Harmful if inhaled.) is proposed. DERMAL EXPOSURE No data available ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e47bfcf7-6913-48b4-b4b7-0dc7ec9b07f0/documents/IUC5-47559616-6533-4c03-a99e-91fd642f584b_cfd3a2f2-f700-4d1a-a4ab-da49c377029e.html,,,,,, "1,2-diethoxybenzene",2050-46-6,"- Acute toxicity: oral: LD50 (rat): > 2000 mg/kg bw (Kr: 2, Rhodia data). 1,2-diethoxybenzene is considered as not harmful if swallowed.- Acute toxicity: dermal: no data available- Acute toxicity: inhalation: no data available ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c71441e-9ada-467c-93e5-5d7adc6be94e/documents/IUC5-b9bb565c-d489-46c1-b817-7d6e4fb1ac17_8ee2799e-9015-4b1b-96f6-f5b3e2ff5bb7.html,,,,,, "1,2-diethoxypropane",10221-57-5," Repeated dose toxicity (oral, subacute): NOAEL = 100 mg/kg bw/day (equivalent or similar to OECD 407/GLP) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07e33599-15af-48fe-9507-2e0becbb721e/documents/31a732e5-d689-4010-80e3-6154709fd541_da7f2b62-b1f5-479d-94ce-64f0f3462ad4.html,,,,,, "1,2-diethoxypropane",10221-57-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07e33599-15af-48fe-9507-2e0becbb721e/documents/31a732e5-d689-4010-80e3-6154709fd541_da7f2b62-b1f5-479d-94ce-64f0f3462ad4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1,2-diethoxypropane",10221-57-5, Acute oral toxicity: LD50 (male/female) > 2000 mg/kg bw (equivalent or similar to OECD 401/GLP) Acute dermal toxicity: LD50 (male/female) > 2000 mg/kg bw (equivalent or similar to OECD 402/GLP) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07e33599-15af-48fe-9507-2e0becbb721e/documents/e98871dc-64a9-47d2-bf5c-dd79ea4c1ea7_da7f2b62-b1f5-479d-94ce-64f0f3462ad4.html,,,,,, "1,2-diethoxypropane",10221-57-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07e33599-15af-48fe-9507-2e0becbb721e/documents/e98871dc-64a9-47d2-bf5c-dd79ea4c1ea7_da7f2b62-b1f5-479d-94ce-64f0f3462ad4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,2-diethoxypropane",10221-57-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07e33599-15af-48fe-9507-2e0becbb721e/documents/e98871dc-64a9-47d2-bf5c-dd79ea4c1ea7_da7f2b62-b1f5-479d-94ce-64f0f3462ad4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,2-Dihydro-2,2,4-trimethylquinoline, oligomers",26780-96-1,NOEL for repeated dose toxicity is considered to be 250 ppm (11.8 mg/kg-bw/day) in a chronic 2-years study in rats ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2b59a22-7fa2-49a6-bc0c-b224ed63be21/documents/IUC5-2f47eb7d-0d0c-44d1-8445-0d5074182bf3_f8373311-8372-4a9d-8ae7-941b4b19c3c1.html,,,,,, "1,2-Dihydro-2,2,4-trimethylquinoline, oligomers",26780-96-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2b59a22-7fa2-49a6-bc0c-b224ed63be21/documents/IUC5-2f47eb7d-0d0c-44d1-8445-0d5074182bf3_f8373311-8372-4a9d-8ae7-941b4b19c3c1.html,Chronic toxicity – systemic effects,oral,NOAEL,12 mg/kg bw/day,,rat "1,2-Dihydro-2,2,4-trimethylquinoline, oligomers",26780-96-1,TMQ is of low acute toxicity by the oral and the dermal route of exposure.There are no studies available which evaluate acute inhalation toxicity. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2b59a22-7fa2-49a6-bc0c-b224ed63be21/documents/IUC5-6ea49aa0-9d1e-4ade-a0a5-48e26d6ec4e7_f8373311-8372-4a9d-8ae7-941b4b19c3c1.html,,,,,, "1,2-Dihydro-2,2,4-trimethylquinoline, oligomers",26780-96-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2b59a22-7fa2-49a6-bc0c-b224ed63be21/documents/IUC5-6ea49aa0-9d1e-4ade-a0a5-48e26d6ec4e7_f8373311-8372-4a9d-8ae7-941b4b19c3c1.html,,oral,LD50,"3,190 mg/kg bw",, "1,2-Dihydro-2,2,4-trimethylquinoline, oligomers",26780-96-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2b59a22-7fa2-49a6-bc0c-b224ed63be21/documents/IUC5-6ea49aa0-9d1e-4ade-a0a5-48e26d6ec4e7_f8373311-8372-4a9d-8ae7-941b4b19c3c1.html,,dermal,LD50,"5,010 mg/kg bw",, "1,2-dihydro-3H-1,2,4-triazol-3-one",930-33-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Good ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/050d9ecd-9578-470e-9753-188214b44535/documents/3643beeb-c4d8-42bf-9bed-a624a85bd27f_214d18a4-6d39-41e9-b112-1e300638c7ca.html,,,,,, "1,2-dihydro-3H-1,2,4-triazol-3-one",930-33-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/050d9ecd-9578-470e-9753-188214b44535/documents/3643beeb-c4d8-42bf-9bed-a624a85bd27f_214d18a4-6d39-41e9-b112-1e300638c7ca.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat "1,2-dihydro-3H-1,2,4-triazol-3-one",930-33-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Correct Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Waived study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Waived study ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/050d9ecd-9578-470e-9753-188214b44535/documents/71432ef9-983f-4475-857c-14ab6cc9ff53_214d18a4-6d39-41e9-b112-1e300638c7ca.html,,,,,, "1,2-dihydro-3H-1,2,4-triazol-3-one",930-33-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/050d9ecd-9578-470e-9753-188214b44535/documents/71432ef9-983f-4475-857c-14ab6cc9ff53_214d18a4-6d39-41e9-b112-1e300638c7ca.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1',2'-dihydro-4'-methyl-6'-oxido-2'-oxo-1,3'-bipyridinium",68532-86-5, The acute oral toxicity of test material in the female Wistar rat was estimated to be >2000 mg/kg bw in acute oral toxicity test performed according to OECD TG 420 and GLP. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8890c2f-0ca7-4355-b2ad-d1367f2ae46a/documents/1508c17c-51b3-4eaa-8877-98fe03850761_b932ac5d-8480-4723-a893-4c793a1d4bfc.html,,,,,, "1,2-dihydro-5-nitro-3H-1,2,4-triazol-3-one",932-64-9," NOAEL for 90-day repeat dose toxicity study in rats was 100 mg NTO/kg/day based on effects on testes. This key study result is supported by the OECD 422 combined repeated dose toxicity study and screening for reproduction/developmental toxicity study. In this study doses of 31.25, 125, and 500 mg/kg bw/day NTO in corn oil were administered to Sprague-Dawley rats for four weeks. Although the dose of 500 mg/kg bw/day resulted in testes degeneration, reduced sperm counts with no motile sperm observed, this dose did not affect reproduction or development. Therefore the NOAELs for reproduction and developmental toxicity are 125 and 500 mg/kg/day, respectively. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62347955-f098-4d16-b76d-1a70dc61a552/documents/IUC5-2288e4b8-0b2f-4787-ba60-21f636a8a897_8535aa58-4c01-48d7-8969-b4192f3e88f0.html,,,,,, "1,2-dihydro-5-nitro-3H-1,2,4-triazol-3-one",932-64-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62347955-f098-4d16-b76d-1a70dc61a552/documents/IUC5-2288e4b8-0b2f-4787-ba60-21f636a8a897_8535aa58-4c01-48d7-8969-b4192f3e88f0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1,2-dihydro-6-hydroxy-1,4-dimethyl-2-oxo-5-[[3-[(phenylsulphonyl)oxy]phenyl]azo]nicotinonitrile",59312-61-7, The acute oral as well as dermal LD50 of FAT 93460 were considered to be >2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7dd65157-ec07-486e-a2bc-ef621dc3a77f/documents/27eb9b5d-2bf3-403e-a212-888133264ae8_9955f87c-d506-4aeb-9bb5-45512299e15a.html,,,,,, "1,2-dihydro-6-hydroxy-1,4-dimethyl-2-oxo-5-[[3-[(phenylsulphonyl)oxy]phenyl]azo]nicotinonitrile",59312-61-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7dd65157-ec07-486e-a2bc-ef621dc3a77f/documents/27eb9b5d-2bf3-403e-a212-888133264ae8_9955f87c-d506-4aeb-9bb5-45512299e15a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,2-dihydro-6-hydroxy-1,4-dimethyl-2-oxo-5-[[3-[(phenylsulphonyl)oxy]phenyl]azo]nicotinonitrile",59312-61-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7dd65157-ec07-486e-a2bc-ef621dc3a77f/documents/27eb9b5d-2bf3-403e-a212-888133264ae8_9955f87c-d506-4aeb-9bb5-45512299e15a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,2-dimethylimidazole",1739-84-0,"Sub-chronic repeated dose toxicity study (90-day study), rat, OECD 408, under GLP, NOAEL = 100 mg/kg bw/day, K1 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10083b44-2bd2-45f3-b915-a25b4005b84f/documents/IUC5-68866e44-e737-4fe1-9b01-5aeed208b1c0_561b5d6e-52b9-4a03-a9de-73bc8984a6f0.html,,,,,, "1,2-dimethylimidazole",1739-84-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10083b44-2bd2-45f3-b915-a25b4005b84f/documents/IUC5-68866e44-e737-4fe1-9b01-5aeed208b1c0_561b5d6e-52b9-4a03-a9de-73bc8984a6f0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1,2-dimethylimidazole",1739-84-0,"Acute toxicity - oral, rat, OECD 401, non-GLP, LD50 = 1300 mg/kg bw, K2 Acute toxicity - inhalation, rat, OECD 403, non-GLP, discriminating conc. = 3 mg/l, K2 Acute toxicity - dermal, rabbit, OECD 402, non-GLP, discriminating dose = 200 mg/kg bw, K2 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10083b44-2bd2-45f3-b915-a25b4005b84f/documents/IUC5-6e4978f8-612f-46c5-afcf-7ecac4eaf92c_561b5d6e-52b9-4a03-a9de-73bc8984a6f0.html,,,,,, "1,2-dimethylimidazole",1739-84-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10083b44-2bd2-45f3-b915-a25b4005b84f/documents/IUC5-6e4978f8-612f-46c5-afcf-7ecac4eaf92c_561b5d6e-52b9-4a03-a9de-73bc8984a6f0.html,,oral,LD50,"1,300 mg/kg bw",adverse effect observed, "1,2-dimethylimidazole",1739-84-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10083b44-2bd2-45f3-b915-a25b4005b84f/documents/IUC5-6e4978f8-612f-46c5-afcf-7ecac4eaf92c_561b5d6e-52b9-4a03-a9de-73bc8984a6f0.html,,dermal,discriminating dose,200 mg/kg bw,no adverse effect observed, "1,2-dimethylimidazole",1739-84-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10083b44-2bd2-45f3-b915-a25b4005b84f/documents/IUC5-6e4978f8-612f-46c5-afcf-7ecac4eaf92c_561b5d6e-52b9-4a03-a9de-73bc8984a6f0.html,,inhalation,discriminating conc.,3 mg/L,no adverse effect observed, "1,2-diphenoxyethane",104-66-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/177e4ac3-95a8-495f-9c5e-603aafe9ed8e/documents/IUC5-d8b36195-48fb-4801-b879-a5fd08399061_863c7f28-0626-4251-9bf0-254b20c97822.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1,2-diphenoxyethane",104-66-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/177e4ac3-95a8-495f-9c5e-603aafe9ed8e/documents/IUC5-c8190f93-423a-4bc7-9862-3e01588555dd_863c7f28-0626-4251-9bf0-254b20c97822.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "1,2-epoxycyclohexane",286-20-4,"REPEAT DOSE ORAL TOXICITYThe oral toxicity of the test material was determined in a 28 day repeat dose toxicity study. No systematic signs of toxicity were observed in the key study (Sauer, 1977) at a concentration of 100 mg/kg and it was concluded that the test material is readily metabolised. Foulger (1948) has been provided as a supporting study which recorded no systemic signs of toxicity at 200 mg/kg.REPEAT DOSE DERMAL TOXICITYThe dermal toxicity of the test material was determined in a key study (Sauer, 1977). No systematic signs of toxicity were observed at a concentration of 60 mg/kg and it was concluded that the test material is readily metabolised and not readily absorbed by the skin. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89695ae8-79b3-41a2-9280-6b9393e7e3f6/documents/IUC5-30537bda-0e0b-4029-86b6-159eeeb92d03_24f42f6f-8814-490c-a45f-1377a7adcef2.html,,,,,, "1,2-epoxycyclohexane",286-20-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89695ae8-79b3-41a2-9280-6b9393e7e3f6/documents/IUC5-30537bda-0e0b-4029-86b6-159eeeb92d03_24f42f6f-8814-490c-a45f-1377a7adcef2.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,60 mg/kg bw/day,,rat "1,2-epoxycyclohexane",286-20-4,"ORALLD50 = 1054.03 mg/kg bw (male rat); sound scientific principles; Smyth, 1969INHALATIONLC50 = > 6.6 mg/l (4h) rat; weight of evidence basisDERMALLD50 = 609.21mg/kg bw (rabbit); sound scientific principles; Smyth, 1969 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89695ae8-79b3-41a2-9280-6b9393e7e3f6/documents/IUC5-bfc347a8-f1a0-49d9-ac1a-7ca13f147e53_24f42f6f-8814-490c-a45f-1377a7adcef2.html,,,,,, "1,2-epoxycyclohexane",286-20-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89695ae8-79b3-41a2-9280-6b9393e7e3f6/documents/IUC5-bfc347a8-f1a0-49d9-ac1a-7ca13f147e53_24f42f6f-8814-490c-a45f-1377a7adcef2.html,,oral,LD50,"1,054.03 mg/kg bw",adverse effect observed, "1,2-epoxycyclohexane",286-20-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89695ae8-79b3-41a2-9280-6b9393e7e3f6/documents/IUC5-bfc347a8-f1a0-49d9-ac1a-7ca13f147e53_24f42f6f-8814-490c-a45f-1377a7adcef2.html,,dermal,LD50,609.21 mg/kg bw,adverse effect observed, "1,2-epoxycyclohexane",286-20-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89695ae8-79b3-41a2-9280-6b9393e7e3f6/documents/IUC5-bfc347a8-f1a0-49d9-ac1a-7ca13f147e53_24f42f6f-8814-490c-a45f-1377a7adcef2.html,,inhalation,LC50,"6,600 mg/m3",adverse effect observed, "1,2-Ethanediamine 4-methylbenzenesulfonate (1:1)",14034-59-4,An oral LD50 of 1410 mg/kg bw for p-toluenesulhonate and an oral LD50 of 841 mg/kg bw for ethylenediamine (both constituents of ethylenediamine p-toluenesulphonate) were determined in two acute oral toxicity studies. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee91c9bd-6da2-4745-ae6f-2214d03e11fb/documents/IUC5-6a8bdc08-c3f3-42f0-965a-d6cc269c2c7f_67a51f15-7b04-4534-8338-7723b1ba4aae.html,,,,,, "1,2-Ethanediamine 4-methylbenzenesulfonate (1:1)",14034-59-4,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee91c9bd-6da2-4745-ae6f-2214d03e11fb/documents/IUC5-6a8bdc08-c3f3-42f0-965a-d6cc269c2c7f_67a51f15-7b04-4534-8338-7723b1ba4aae.html,,oral,LD50,841 mg/kg bw,adverse effect observed, "1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether",84144-79-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18728e31-4f4e-444d-877f-46b3077fd244/documents/72ee46a4-2572-4097-aa1e-ee536cf22b3c_43609f61-c953-4df8-8bd7-7ab1c2c4b4e4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "1,2-Ethanediamine, N-(2-aminoethyl)-, reaction products with glycidyl tolyl ether",84144-79-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18728e31-4f4e-444d-877f-46b3077fd244/documents/6f97e6f7-9db7-4e78-8f8f-d1c5dbbf2ce0_43609f61-c953-4df8-8bd7-7ab1c2c4b4e4.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "1,2-Ethanediamine, N-{3-(trimethoxysilyl)propyl}-,N-{(ethenylphenyl)methyl}derivate,hydrochlorides",171869-89-9,"Screening study for reproductive/developmental toxicity (OECD 422, oral, rat): NOAEL systemic toxicity = 100 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/316cd423-3e0b-4157-82cf-0b34733d6cd0/documents/a8690181-99c8-4841-8907-690867bbe6a5_075ee69e-d9d9-474e-8a5a-073240da61a0.html,,,,,, "1,2-Ethanediamine, N-{3-(trimethoxysilyl)propyl}-,N-{(ethenylphenyl)methyl}derivate,hydrochlorides",171869-89-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/316cd423-3e0b-4157-82cf-0b34733d6cd0/documents/a8690181-99c8-4841-8907-690867bbe6a5_075ee69e-d9d9-474e-8a5a-073240da61a0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1,2-Ethanediamine, N-{3-(trimethoxysilyl)propyl}-,N-{(ethenylphenyl)methyl}derivate,hydrochlorides",171869-89-9,"Oral (EPA OPPTS 870.1100), rat: LD50 = 2295 mg/kg bw (RA from CAS 1760-24-3) Inhalation (EPA OPPTS 870.1300), rat: LC50 = 1.49 - 2.44 mg/L (RA from CAS 1760-24-3) Dermal (EPA OPPTS 870.1200), rabbit: LD50 > 2000 mg/kg bw (RA from CAS1760-24-3)   Furthermore, the registration substance contains 40% silane and 60% methanol. Therefore, the harmonised EU classification of methanol has to be taken into account for the evalulation of the hazard of CAS 171869-89-9. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/316cd423-3e0b-4157-82cf-0b34733d6cd0/documents/80b6f10e-3014-4ec9-b22e-e02a6298152b_075ee69e-d9d9-474e-8a5a-073240da61a0.html,,,,,, "Reaction products of 1-chlorooctadecane with N-(2-aminoethyl)ethane-1,2-diamine, post reacted with 2-phenyloxirane",1629160-48-0," The acute oral median lethal dose (LD50) of FAT 92'267/A in rats of both sexes, observed over a period of 15 days, was estimated to be greater than 2000 mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6f44c94-7884-4ab7-ac6b-a02eca3d47ac/documents/IUC5-d6b31530-3591-4f76-b542-676c2e38ef1f_99156969-329f-49f2-9037-fc8302324c39.html,,,,,, "Reaction products of 1-chlorooctadecane with N-(2-aminoethyl)ethane-1,2-diamine, post reacted with 2-phenyloxirane",1629160-48-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6f44c94-7884-4ab7-ac6b-a02eca3d47ac/documents/IUC5-d6b31530-3591-4f76-b542-676c2e38ef1f_99156969-329f-49f2-9037-fc8302324c39.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Oxirane, [(4-nonylphenoxy)methyl]-, reaction product with ethylene glycol",634602-80-5, One Acute oral toxicity study in female Wistar rats ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d100a1f-e837-4983-9a1b-3781acd45851/documents/8ecc29b3-bd36-40ce-abde-47e36bc77b31_e73afca3-aa4c-4d29-a197-7922637b6edd.html,,,,,, "1,2-Heptanediol",3710-31-4,"In a key subchronic dermal toxicity study according to OECD guideline 411 and GLP, the NOAEL of the analogue substance DL-hexane-1,2-diol (CAS 6920-22-5) was 700 mg/kg/day, and the highest dose level of 1000 mg/kg/day was considered to be a minimal LOAEL. Thus, the target substance is considered to also have a NOAEL of 700 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63e0b331-dec9-4974-abec-c062b5826b1d/documents/e8f0eec4-a92f-4022-ab4f-e315c0b70bb3_d8b864c2-cdfb-4bf3-b23a-233581ffe5fe.html,,,,,, "1,2-Heptanediol",3710-31-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63e0b331-dec9-4974-abec-c062b5826b1d/documents/e8f0eec4-a92f-4022-ab4f-e315c0b70bb3_d8b864c2-cdfb-4bf3-b23a-233581ffe5fe.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,700 mg/kg bw/day,,rat "1,2-Heptanediol",3710-31-4,"In the key acute oral toxicity study with the analogue substance DL-hexane-1,2-diol (CAS 6920-22-5) similar to OECD 401, an LD50 of 6166 mg/kg bw (males) and 5339-5470 mg/kg bw (females) was determined. Thus, the target substance is considered to also have a LD50 of > 2000 mg/kg bw. The value for males 6166 mg/kg bw, determined by probit analysis, is taken forward for hazard and risk assessment. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63e0b331-dec9-4974-abec-c062b5826b1d/documents/d63b9ffb-fc0e-479c-b7d6-32c09a0904d0_d8b864c2-cdfb-4bf3-b23a-233581ffe5fe.html,,,,,, "1,2-Heptanediol",3710-31-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63e0b331-dec9-4974-abec-c062b5826b1d/documents/d63b9ffb-fc0e-479c-b7d6-32c09a0904d0_d8b864c2-cdfb-4bf3-b23a-233581ffe5fe.html,,oral,LD50,"6,166 mg/kg bw",no adverse effect observed, "(S)-1-(4-Ethoxybenzyl)-3-azapentane-1,5-diaminedihydrochlorid",221640-21-7,"LD50 oral (rat):> 300 < 2000 mg/kg bw [draft report, Kurth 1996]LD50 dermal (rat): > 2000 mg/kg bw [draft report, Kurth 1996] ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/379dc2ec-55a4-47e3-9d83-8a2426c51b77/documents/IUC5-1704f594-d1d7-404e-bcb2-b44195c19dcd_29b1b3a1-127d-41ee-9ff3-ee400b107975.html,,,,,, "(S)-1-(4-Ethoxybenzyl)-3-azapentane-1,5-diaminedihydrochlorid",221640-21-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/379dc2ec-55a4-47e3-9d83-8a2426c51b77/documents/IUC5-1704f594-d1d7-404e-bcb2-b44195c19dcd_29b1b3a1-127d-41ee-9ff3-ee400b107975.html,,oral,discriminating dose,200 mg/kg bw,adverse effect observed, "(S)-1-(4-Ethoxybenzyl)-3-azapentane-1,5-diaminedihydrochlorid",221640-21-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/379dc2ec-55a4-47e3-9d83-8a2426c51b77/documents/IUC5-1704f594-d1d7-404e-bcb2-b44195c19dcd_29b1b3a1-127d-41ee-9ff3-ee400b107975.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "(2S,4R)-4-hydroxy-1-[(2-methylpropan-2-yl)oxycarbonyl]pyrrolidine-2-carboxylic acid",13726-69-7," No data were found for the substance in the scientific literature. Acute toxicity oral - SDSs report that the substance is classified as ""harmful if swallowed"", but no information was reported to justify this hazard. Overall, this endpoint is considered inconclusive for the classification. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20c67470-4b6c-4978-953c-17507aa6e205/documents/8c9a25e6-68bc-40d2-a5e2-4300a32c4ce4_3409dfc9-ff45-4320-9f36-3ce9c0fa656a.html,,,,,, "1,3,2-dioxathiolane 2,2-dioxide",1072-53-3," Based on the hydrolysis results (hydrolysis half-life t1/2 < 2 min) and corrosive properties of the substance, a repeated dose oral toxicity study was waived as technically not feasible due to the substances instability in the dosing aqueous solutions/food and animal distress prevention, respectively. In addition, carcinogenicity data is available on the substance and structurally similar analogue substances. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78e135a6-5791-4273-aff1-30118ba4137e/documents/f8acd55e-6ef6-4cf0-a7e4-5ea9d5a1625e_bfae8b98-fc39-4ef1-8a72-8aacf3dcf38f.html,,,,,, "1,3,2-dioxathiolane 2,2-dioxide",1072-53-3," Acute Oral Toxicity: The test substance, ESA, was administered in single dose to female Sprague-Dawley (SD) to evaluate the lethal dose 50 (LD50) and acute toxicity. A starting dose level was set as 300 mg/kg because the toxicological information of the test substance was not known. During study period, mortalities, clinical signs and body weight changes and gross findings at necropsy were examined. In the first and second steps (300 mg/kg), No mortalities and unusual clinical signs were observed during the observation period. In body weights, there were no changes related with the test substance. And abnormal gross findings were not detected in necropsy at the termination of observations. In the third step (2,000 mg/kg), all animals died on the day of dosing (day 0) and day 1. Crawling position was observed in all animals at 30 minutes after administration. No. 8 animal died immediately. No. 9 animal showed coma and terminal respiration at 1 hour and died at 2 hours after administration. No. 7 animal had crouching position and piloerection at 1 hour after administration and piloerection persisted on day 0. The animal died on day 1 finally. Necropsy of the decedents revealed the following; In animals died on day 0, glandular stomach was coated with black material and area of liver where is adjacent to stomach was discolored with grey-green. In an animal died on day 1, gastric filling with black substance and black coating in glandular stomach were founded in stomach and area of liver where is adjacent to stomach was discolored with light brown. Therefore, the test substance ESA is considered to be classified as GHS category 4 (300 < LD50 cut-off ≤ 2,000 mg/kg b.w.) under present study conditions. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78e135a6-5791-4273-aff1-30118ba4137e/documents/214840e2-2af5-489b-9be0-04973ff78c6e_bfae8b98-fc39-4ef1-8a72-8aacf3dcf38f.html,,,,,, "1,3,2-dioxathiolane 2,2-dioxide",1072-53-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78e135a6-5791-4273-aff1-30118ba4137e/documents/214840e2-2af5-489b-9be0-04973ff78c6e_bfae8b98-fc39-4ef1-8a72-8aacf3dcf38f.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, "1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium chloride",68134-38-3, Oral Toxicity LD50: 300-400 mg/kg bw Inhalation toxicity LD50: 0.75 mg/l (correspond to 750 mg/m3) Dermal toxicity LD50 :1500 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa435c1a-c6ca-470c-aa8f-72fb8b237f96/documents/a32c7dca-977e-4ef5-9839-5f3bafcfe257_649a6b17-fb6d-4590-a0a3-7fa4c1b567bc.html,,,,,, "1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium chloride",68134-38-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa435c1a-c6ca-470c-aa8f-72fb8b237f96/documents/a32c7dca-977e-4ef5-9839-5f3bafcfe257_649a6b17-fb6d-4590-a0a3-7fa4c1b567bc.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium chloride",68134-38-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa435c1a-c6ca-470c-aa8f-72fb8b237f96/documents/a32c7dca-977e-4ef5-9839-5f3bafcfe257_649a6b17-fb6d-4590-a0a3-7fa4c1b567bc.html,,dermal,LD50,"1,500 mg/kg bw",adverse effect observed, "1,3,3-trimethyl-2-[[methyl(p-tolyl)hydrazono]methyl]-3H-indolium chloride",68134-38-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa435c1a-c6ca-470c-aa8f-72fb8b237f96/documents/a32c7dca-977e-4ef5-9839-5f3bafcfe257_649a6b17-fb6d-4590-a0a3-7fa4c1b567bc.html,,inhalation,LC50,750 mg/m3,adverse effect observed, "1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethylamine",54914-37-3,"As 1,3,3 -trimethyl-N-(2 -methylpropylidene)-5 -[(2 -methylpropylidene)amino]cyclohexanemethylamine hydrolises to the products isophorondiamin (IPDA) and isobutyraldehyde, those hydrolysis products are assessed. In a subchronic drinking water study according to OECD TG 408 with rats, the administration of 150 mg/kg bw/day led to reduced absolute and relative kidney weights in male and female rats (histopathology being indicative for tubular nephrosis), while 59 mg/kg bw/day (males) and 62 mg/kg bw/day (females) were determined as a NOAEL (RCC 1986).     In a dose range finding study for an OECD 422 study (LPT 2020), rats showed some clinical signs such as salivation and breathing sounds in the highest dose group of 500/350 mg/kg bw. Because one male animal died in first week, the highest dose was reduced from 500 to 350 mg/kg bw/d.There was a significantly reduced food consumption in both (high) dose groups, which lead to significantly reduced body weight in the first week of application. As the food consumption recovered during the second test week, the reductions that were noted during the first test week are not considered to be of toxicological relevance. Necropsy revealed test item related gastrointestinal changes for some male and female animals of the high dose group (500/350 mg /kg b.w./day). Based on the results the following dose levels are recommended for the OECD 422 study: 30 mg/ kg/b.w./day (low dose), 100 mg/ kg/b.w./day (intermediate dose), 300 mg/ kg/b.w./day (high dose). The aim of the subsequently performed study was to obtain information on possible effects of the test item on general toxicity, reproduction and/or development according to OECD guideline 422. The test item was administered orally to rats at dose levels of 30, 100 or 300 mg/kg b.w./day. Due to mortality, the high dose level was decreased to 240 mg/kg b.w./day, starting on test day 28.Additionally, this OECD 422 serves as dose range finding study for the OECD 443 study. The NOAEL for general toxicity is considered to be 100 mg/ kg bw/day (Provivo, 2022) From two 14-day inhalative exposure studies with rats no NOAEL could be determined. At the first study’s LOAEL of 18 mg/m3, degeneration/necrosis in the olfactory epithelium of the nose were observed. Trachea, larynx and lungs were affected at 200 mg/m3 and above (degeneration/ necrosis, hyperplasia, squamous metaplasia) (DuPont, 1997). At the LOAEL of the follow-up study, i.e. at 2.2 mg/m³, reversible minimal to mild degeneration of respiratory nasal mucosa in the anterior dorsal nose was observed (DuPont, 2001).    Isobutyraldehyde administered by inhalation (whole body exposure) for up to Thirteen Weeks or Two Years was a Respiratory Tract Toxicant but was not carcinogenic in F344/N Rats and B6C3F, Mice (Abdo 1998). Isobutyraldehyde was studied for toxicity and carcinogenicity by exposing male and female F344/N rats and B6C3F, mice. Animals were exposed to isobutyraldehyde vapors 6 h per day, 5 days per week for up to 13 weeks or 2 years. In the 13-week studies, groups of 10 male and 10 female F344/N rats and B6C3F, mice were exposed to concentrations of 0, 500, 1000, 2000, 4000, or 8000 ppm. Chemical-related body weight depression and deaths occurred in rats and mice exposed to 4000 and 8000 ppm. Necrosis of the epithelium accompanied with acute inflammatory reaction was observed in the nasal turbinate, larynx, and trachea of rats exposed to 8000 ppm. Exposure of rats to 4000 ppm resulted in metaplasia of the nasal respiratory epithelium, inflammation, degeneration of the olfactory epithelium, and osteodystrophy of the nasal turbinate bone. In the 13-week mouse study, exposure to 8000 ppm or 4000 ppm resulted in necrosis of the epithelium lining of the nasal turbinates. Osteodystrophy of the nasal turbinate bone and squamous metaplasia of the nasal respiratory epithelium were noted in mice exposed 4000 ppm. Degeneration of the olfactory epithelium was noted in males exposed 2000 ppm and in females exposed to 4000 ppm. In the 2-year studies, groups of 50 male and 50 male F344/ N rats and B6C3F1 were exposed to concentrations isobutyraldehyde vapors of 0, 500, 1000, or 2000 ppm 6 h per day, 5 days per week. There were no differences in survival rates or mean body weights between exposed groups and control rats. Survival of male mice exposed to 2000 ppm and mean body weights of female mice exposed to 1000 or 2000 ppm were lower than those of the of the controls. No increase in neoplasm incidence was observed in rats and mice in the 2-year studies that could be attributed to isobutyraldehyde exposure. Chemical-related nonneoplastic lesions were limited to the nose of rats and mice. They included squamous metaplasia of the respiratory epithelium (rats), suppurative inflammation (rats), and olfactory epithelial degeneration (rats and mice) at 1000 and 2000 ppm. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4fe60d6c-8912-4c76-ba4e-5cc2f3e4ab69/documents/IUC5-dc26660c-f037-43f6-a3d5-53ecc9810311_f3979fe5-d974-4c95-ae70-124966f94ec3.html,,,,,, "1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethylamine",54914-37-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4fe60d6c-8912-4c76-ba4e-5cc2f3e4ab69/documents/IUC5-dc26660c-f037-43f6-a3d5-53ecc9810311_f3979fe5-d974-4c95-ae70-124966f94ec3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,59 mg/kg bw/day,,rat "1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethylamine",54914-37-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4fe60d6c-8912-4c76-ba4e-5cc2f3e4ab69/documents/IUC5-dc26660c-f037-43f6-a3d5-53ecc9810311_f3979fe5-d974-4c95-ae70-124966f94ec3.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"3,000 mg/m3",,rat "1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethylamine",54914-37-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4fe60d6c-8912-4c76-ba4e-5cc2f3e4ab69/documents/IUC5-dc26660c-f037-43f6-a3d5-53ecc9810311_f3979fe5-d974-4c95-ae70-124966f94ec3.html,Repeated dose toxicity – local effects,inhalation,LOAEC,18 mg/m3,adverse effect observed,rat "1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethylamine",54914-37-3,"1,3,3 -Trimethyl-N-(2 -methylpropylidene)-5 -[(2 -methylpropylidene) amino]cyclohexane-methylamine is of oral and dermal acute toxicity with an oral LD50 (rat) of 4150 mg/kg bw (Hüls AG, 1985) and a dermal LD50 > 5000 mg/kg bw (Hüls AG, 1985). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is reliable without restriction (Klimisch score 1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study is reliable without restriction (Klimisch score 1) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fe60d6c-8912-4c76-ba4e-5cc2f3e4ab69/documents/IUC5-51beec5b-b7b3-4c0c-9e85-957699c4dff8_f3979fe5-d974-4c95-ae70-124966f94ec3.html,,,,,, "1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethylamine",54914-37-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fe60d6c-8912-4c76-ba4e-5cc2f3e4ab69/documents/IUC5-51beec5b-b7b3-4c0c-9e85-957699c4dff8_f3979fe5-d974-4c95-ae70-124966f94ec3.html,,oral,LD50,"4,150 mg/kg bw",adverse effect observed, "1,3,3-trimethyl-N-(2-methylpropylidene)-5-[(2-methylpropylidene)amino]cyclohexanemethylamine",54914-37-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fe60d6c-8912-4c76-ba4e-5cc2f3e4ab69/documents/IUC5-51beec5b-b7b3-4c0c-9e85-957699c4dff8_f3979fe5-d974-4c95-ae70-124966f94ec3.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "1,3,4,6,7,9,9b-heptaazaphenalene-2,5,8-triamine",1502-47-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30bc4757-dca2-4b1f-b9fe-980d89207522/documents/6b1904a0-7e60-4ce2-818b-cd946ad6dcf3_4896ad3d-0daf-4357-a2b2-6bfd0be83b5f.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1,3,4,6,7,9,9b-heptaazaphenalene-2,5,8-triamine",1502-47-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30bc4757-dca2-4b1f-b9fe-980d89207522/documents/6b1904a0-7e60-4ce2-818b-cd946ad6dcf3_4896ad3d-0daf-4357-a2b2-6bfd0be83b5f.html,,dermal,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, "1,3,4,6,7,9,9b-heptaazaphenalene-2,5,8-triamine",1502-47-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30bc4757-dca2-4b1f-b9fe-980d89207522/documents/6b1904a0-7e60-4ce2-818b-cd946ad6dcf3_4896ad3d-0daf-4357-a2b2-6bfd0be83b5f.html,,inhalation,LC50,> 5.33 mg/L,no adverse effect observed, "1,3,5-Benzenetricarboxylic acid, copper(2+) salt (2:3)",309721-49-1,"OECD 423 (BASF SE, 2015): 300 < LD50 < 2000 mg/kg bw ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1381a0e5-e6bd-4d5d-a1a4-b84caa24f9ef/documents/IUC5-47212d40-02f5-4dae-9685-8913252ea3fc_ea04f79d-48fb-42c5-8ae0-861da77207fa.html,,,,,, "1,3,5-Benzenetricarboxylic acid, copper(2+) salt (2:3)",309721-49-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1381a0e5-e6bd-4d5d-a1a4-b84caa24f9ef/documents/IUC5-47212d40-02f5-4dae-9685-8913252ea3fc_ea04f79d-48fb-42c5-8ae0-861da77207fa.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "1,3,5-triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",1025-15-6,28 days oral NOAEL (male rat): 15 mg/kg bw/day28 days oral LOAEL (male rat): 50 mg/kg bw/day28 days oral NOAEL (female rat): ≥50 mg/kg bw/day ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f792f7fe-1678-4fe4-8c89-2ced9de9d6be/documents/19d6c3b2-a11c-44d8-84c2-290f940e2801_dd56ea29-b737-4a6b-8ded-befff4587465.html,,,,,, "1,3,5-triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",1025-15-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f792f7fe-1678-4fe4-8c89-2ced9de9d6be/documents/19d6c3b2-a11c-44d8-84c2-290f940e2801_dd56ea29-b737-4a6b-8ded-befff4587465.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "1,3,5-triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",1025-15-6,"Oral (OECD TG 401), rat: LD50 (female): 812 mg/kg bw; LD50 (male): 707 mg/kg bwDermal (OECD TG 402), rat: LD50 (female) > 2000 mg/kg bw Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): GLP guideline study ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f792f7fe-1678-4fe4-8c89-2ced9de9d6be/documents/809cdab3-678b-410d-999c-e17261b35a83_dd56ea29-b737-4a6b-8ded-befff4587465.html,,,,,, "1,3,5-triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",1025-15-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f792f7fe-1678-4fe4-8c89-2ced9de9d6be/documents/809cdab3-678b-410d-999c-e17261b35a83_dd56ea29-b737-4a6b-8ded-befff4587465.html,,oral,LD50,707 mg/kg bw,, "1,3,5-triallyl-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",1025-15-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f792f7fe-1678-4fe4-8c89-2ced9de9d6be/documents/809cdab3-678b-410d-999c-e17261b35a83_dd56ea29-b737-4a6b-8ded-befff4587465.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1,3,5-triazine-2,4,6(1H,3H,5H)-trione, compound with 1,3,5-triazine-2,4,6-triamine (1:1)",37640-57-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b519f93-5d2c-4809-ba8f-be480bddba75/documents/IUC5-bde69bee-66d8-4394-b817-4fe42c059d58_73b4780a-1f27-4762-a08e-06967822555e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,2 mg/kg bw/day,,pig "1,3,5-triazine-2,4,6(1H,3H,5H)-trione, compound with 1,3,5-triazine-2,4,6-triamine (1:1)",37640-57-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b519f93-5d2c-4809-ba8f-be480bddba75/documents/IUC5-bde69bee-66d8-4394-b817-4fe42c059d58_73b4780a-1f27-4762-a08e-06967822555e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,72 mg/kg bw/day,,rat "1,3,5-triazine-2,4,6(1H,3H,5H)-trione, compound with 1,3,5-triazine-2,4,6-triamine (1:1)",37640-57-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b519f93-5d2c-4809-ba8f-be480bddba75/documents/IUC5-d7a95455-f994-45da-89e0-fb960b61a59e_73b4780a-1f27-4762-a08e-06967822555e.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,3,5-triazine-2,4,6(1H,3H,5H)-trione, compound with 1,3,5-triazine-2,4,6-triamine (1:1)",37640-57-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b519f93-5d2c-4809-ba8f-be480bddba75/documents/IUC5-d7a95455-f994-45da-89e0-fb960b61a59e_73b4780a-1f27-4762-a08e-06967822555e.html,,inhalation,discriminating conc.,"5,100 mg/m3",no adverse effect observed, "1,3,5-triazine-2,4,6(1H,3H,5H)-trione, trisodium salt",3047-33-4,"Read-across from repeat dose studies by the oral route ( 59 day, 13 week (according to OECD guideline 408) and 104 weeks (according to EU Method B.33) on cyanuric acid, sodium cyanurate monohydrate or sodium cyanurate. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6fca3962-fe05-4fd9-9dc7-74846c57ce51/documents/IUC5-7423a574-6c8e-4466-b960-770c6c02a373_2fc1aa44-7d3c-4573-9a6d-78d6cf517d03.html,,,,,, "1,3,5-triazine-2,4,6(1H,3H,5H)-trione, trisodium salt",3047-33-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6fca3962-fe05-4fd9-9dc7-74846c57ce51/documents/IUC5-7423a574-6c8e-4466-b960-770c6c02a373_2fc1aa44-7d3c-4573-9a6d-78d6cf517d03.html,Chronic toxicity – systemic effects,oral,NOAEL,176.5 mg/kg bw/day,,rat "1,3,5-triazine-2,4,6(1H,3H,5H)-trione, trisodium salt",3047-33-4,"Read-across from acute oral, dermal and inhalation studies with cyanuric acid. Experimental data showed no evidence of acute toxicity to cyanuric acid. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fca3962-fe05-4fd9-9dc7-74846c57ce51/documents/IUC5-df797141-2f18-456f-9202-61eba195e46a_2fc1aa44-7d3c-4573-9a6d-78d6cf517d03.html,,,,,, "1,3,5-triazine-2,4,6(1H,3H,5H)-trione, trisodium salt",3047-33-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fca3962-fe05-4fd9-9dc7-74846c57ce51/documents/IUC5-df797141-2f18-456f-9202-61eba195e46a_2fc1aa44-7d3c-4573-9a6d-78d6cf517d03.html,,oral,LD50,"7,554.42 mg/kg bw",, "1,3,5-triazine-2,4,6(1H,3H,5H)-trione, trisodium salt",3047-33-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fca3962-fe05-4fd9-9dc7-74846c57ce51/documents/IUC5-df797141-2f18-456f-9202-61eba195e46a_2fc1aa44-7d3c-4573-9a6d-78d6cf517d03.html,,dermal,LD50,"7,554.42 mg/kg bw",, "1,3,5-triazine-2,4,6(1H,3H,5H)-trione, trisodium salt",3047-33-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fca3962-fe05-4fd9-9dc7-74846c57ce51/documents/IUC5-df797141-2f18-456f-9202-61eba195e46a_2fc1aa44-7d3c-4573-9a6d-78d6cf517d03.html,,inhalation,LC50,"7,930 mg/m3",, "1,3,5-triazine-2,4,6(1H,3H,5H)-trithione",638-16-4, OECD TG 422: NOAEL: 125 mg/kg bw/day (male and female) ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56f284b4-5e9f-4c6b-a47f-f40e0dea0fa6/documents/0ee192ff-f3a6-47cf-8dc2-3bbb60afe1b9_f7b27f16-6d3f-4f9b-9fea-d280b4c529f6.html,,,,,, "1,3,5-triazine-2,4,6(1H,3H,5H)-trithione",638-16-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56f284b4-5e9f-4c6b-a47f-f40e0dea0fa6/documents/0ee192ff-f3a6-47cf-8dc2-3bbb60afe1b9_f7b27f16-6d3f-4f9b-9fea-d280b4c529f6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "1,3,5-triazine-2,4,6(1H,3H,5H)-trithione",638-16-4," Acute toxicity after oral exposure in female rats: cut-off LD50 value of 500 mg/kg bw (calculated: LD50 = 1150 mg/kg bw) Acute toxictiy after oral exposure in mice: LD50 = 2280 mg/kg bw (male), LD50 = 2500 mg/kg bw (female) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56f284b4-5e9f-4c6b-a47f-f40e0dea0fa6/documents/4b4283a9-c6c4-406b-b4df-0226d7e7d176_f7b27f16-6d3f-4f9b-9fea-d280b4c529f6.html,,,,,, "1,3,5-triazine-2,4,6(1H,3H,5H)-trithione",638-16-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56f284b4-5e9f-4c6b-a47f-f40e0dea0fa6/documents/4b4283a9-c6c4-406b-b4df-0226d7e7d176_f7b27f16-6d3f-4f9b-9fea-d280b4c529f6.html,,oral,LD50,"1,150 mg/kg bw",adverse effect observed, "1,3,5-triazine-2,4,6(1H,3H,5H)-trithione, trisodium salt",17766-26-6,90 days oral NOAEL (male/female rat): 200 mg anhydrous TMT/kg bw/day ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe91f42a-82eb-48f4-9eef-5d61950e8f7c/documents/IUC5-fba38c2c-c280-457e-9b6a-5f43858ab3e6_bf541a08-2629-4a58-bec3-cea3a3740676.html,,,,,, "1,3,5-triazine-2,4,6(1H,3H,5H)-trithione, trisodium salt",17766-26-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe91f42a-82eb-48f4-9eef-5d61950e8f7c/documents/IUC5-fba38c2c-c280-457e-9b6a-5f43858ab3e6_bf541a08-2629-4a58-bec3-cea3a3740676.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "1,3,5-triazine-2,4,6(1H,3H,5H)-trithione, trisodium salt",17766-26-6,"Oral (similar to OECD 401), male rat: LD50 = 1182 mg anhydrous TMT/kg bw; female rat: LD50 > 1680 mg anhydrous TMT/kg bwDermal (OECD 402), rat: LD50 > 1100 mg anhydrous TMT/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe91f42a-82eb-48f4-9eef-5d61950e8f7c/documents/IUC5-1cbf1127-f511-46c5-b5c1-42f276d49196_bf541a08-2629-4a58-bec3-cea3a3740676.html,,,,,, "1,3,5-triazine-2,4,6(1H,3H,5H)-trithione, trisodium salt",17766-26-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe91f42a-82eb-48f4-9eef-5d61950e8f7c/documents/IUC5-1cbf1127-f511-46c5-b5c1-42f276d49196_bf541a08-2629-4a58-bec3-cea3a3740676.html,,oral,LD50,"1,182 mg/kg bw",adverse effect observed, "1,3,5-triazine-2,4,6-triamine phosphate",41583-09-9,"There is no study available with melamine phosphate but with melamine.Melamine was administered to rats in a daily diet over a period of 13 weeks. Melamine induced the formation of urinary calculi in the bladder and hyperplasia in the bladder epithelium of both sexes (NTP 1983). The effects were dose-related, with the male rats being more sensitive than females to the effects in the bladder. The NOAEL of 750 ppm for males (72 mg/kg bw/day) and 15000 ppm for females (1400 mg/kg bw/day) was considered. Later on, the US FDA has recalculated these results to a NOAEL rat,13w, oral of 63 mg/kg bw/day.Mice were also investigated: The incidence of bladder stones was dose related as in rats, being greater in males than in females, but starting at much higher doses than in rats (NTP 1983). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad92d93a-ea50-4488-8216-f54d8fff3b60/documents/c2d7f350-0b39-4839-829d-b1908bb4f891_e6f6a8c9-fb95-4dda-9f38-6afea573138b.html,,,,,, "1,3,5-triazine-2,4,6-triamine phosphate",41583-09-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad92d93a-ea50-4488-8216-f54d8fff3b60/documents/c2d7f350-0b39-4839-829d-b1908bb4f891_e6f6a8c9-fb95-4dda-9f38-6afea573138b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,72 mg/kg bw/day,,rat "1,3,5-triazine-2,4,6-triamine phosphate",41583-09-9,"Oral: Melamine phosphate is of low acute oral toxicity as determined in a GLP and OECD-guideline compliant study with rats. No indication of toxicity was observed at the limit dose of 2000 mg/kg bw.Inhalation: There is no study available with melamine phosphate but with melamine. Absence of systemic toxicity upon acute inhalation is derived from a GLP and OECD guideline compliant study with melamine tested with an aerosol of 5.19 g/m³.Dermal: As the substance is strongly charged and has a log POW of -3, high dermal absorption is not expected ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad92d93a-ea50-4488-8216-f54d8fff3b60/documents/c258cf23-4ba7-4e2f-9a4b-bd91f2a1472f_e6f6a8c9-fb95-4dda-9f38-6afea573138b.html,,,,,, "1,3,5-triazine-2,4,6-triamine phosphate",41583-09-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad92d93a-ea50-4488-8216-f54d8fff3b60/documents/c258cf23-4ba7-4e2f-9a4b-bd91f2a1472f_e6f6a8c9-fb95-4dda-9f38-6afea573138b.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,3,5-triazine-2,4,6-triamine phosphate",41583-09-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad92d93a-ea50-4488-8216-f54d8fff3b60/documents/c258cf23-4ba7-4e2f-9a4b-bd91f2a1472f_e6f6a8c9-fb95-4dda-9f38-6afea573138b.html,,inhalation,discriminating conc.,"5,190 mg/m3",no adverse effect observed, "1,3,5-Triazine-2,4,6-triamine, deammoniated",68649-66-1," According to section 1 of REACH Regulation (EC) Annex XI, testing for sub-acute toxicity does not need to be conducted if testing does not appear scientifically necessary. For repeated-dose toxicity 1,3,5-Triazine-2,4,6-triamine, deammoniated will have to be made bioavailable to the target organs in sufficient concentration to cause the toxic effect. This requires that the polymer molecules will have to be bioavailable by absorption via relevant routes of exposure. It is therefore unlikely to occur with this insoluble substance .  Since the gut wall presents a substantial barrier to prevent uptake of high molecular weight substances, 1,3,5-Triazine-2,4,6-triamine, deammoniated is unlikly to cross the gastro-intestinal epithelium and to become systemically available for distribution to internal target tissues and organs.  Considering the above mentioned factors,  1,3,5-Triazine-2,4,6-triamine, deammoniated is obviously devoid of toxicity via the oral route, i.e. sub-acute oral toxicity is no relevant toxicological endpoint.  This applies also for any dermal exposure because permeation of a chemical through the Stratum corneum is basically a diffusion process in which active transport plays no role. The layer with the highest resistance to diffusion is the rate-limiting membrane. For many compounds,the lipophilic Stratum corneum is the primary or rate-limiting barrier.  According to the so-called “Dalton rule” the molecular weight of a molecule may not exceed 500 Dalton (500 g/Mol) for a quantitative relevant skin penetration. The molecular weight of 1,3,5-Triazine-2,4,6-triamine, deammoniated is expected to be higher than 500 g/Mol (see mass spectrum and HPLC-analysis). In addition 1,3,5-Triazine-2,4,6-triamine, deammoniated is insoluble in water and not fat soluble, consequently it is not expected to be absorbed through the skin. Taking this into account, dermal absorption of 1,3,5-Triazine-2,4,6-triamine, deammoniated is not expected.  The other appropriate route of exposure to 1,3,5-Triazine-2,4,6-triamine, deammoniated is the inhalative one which is also of no relevance due to the bio-inertness of the substance.   ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8edfb57-5715-4b72-89d8-8901e560fbd3/documents/IUC5-98c34814-b6fa-4661-9eff-c1b7c09d7781_4a06d697-8505-4fef-a68a-8b5c1747e610.html,,,,,, "1,3,5-Triazine-2,4,6-triamine, deammoniated",68649-66-1," 5 male and female (number not defined) Wistar rats were dosed orally by gavage. The oral LD50of REG 1 was higher than 5,110 mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8edfb57-5715-4b72-89d8-8901e560fbd3/documents/IUC5-dbceb501-d61c-4fe4-99a3-08d6d5162833_4a06d697-8505-4fef-a68a-8b5c1747e610.html,,,,,, "1,3,5-Triazine-2,4,6-triamine, deammoniated",68649-66-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8edfb57-5715-4b72-89d8-8901e560fbd3/documents/IUC5-dbceb501-d61c-4fe4-99a3-08d6d5162833_4a06d697-8505-4fef-a68a-8b5c1747e610.html,,oral,LD50,"5,110 mg/kg bw",no adverse effect observed, "N2-[6-[[4,6-bis[butyl-(2,2,6,6-tetramethyl-4-piperidyl)amino]-1,3,5-triazin-2-yl]-(2,2,6,6-tetramethyl-4-piperidyl)amino]hexyl]-N4,N6-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethyl-4-piperidyl)-1,3,5-triazine-2,4,6-triamine",210988-99-1,The oral LD50 in the rat was determined to be greater than 2000 mg/kg. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a2e8623-fd6d-4d16-9719-4a7360e75acb/documents/13573ac5-5611-412d-85df-aef0d682af01_ae8da2be-dfd1-4768-961b-fdaea9088c73.html,,,,,, "N2-[6-[[4,6-bis[butyl-(2,2,6,6-tetramethyl-4-piperidyl)amino]-1,3,5-triazin-2-yl]-(2,2,6,6-tetramethyl-4-piperidyl)amino]hexyl]-N4,N6-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethyl-4-piperidyl)-1,3,5-triazine-2,4,6-triamine",210988-99-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a2e8623-fd6d-4d16-9719-4a7360e75acb/documents/13573ac5-5611-412d-85df-aef0d682af01_ae8da2be-dfd1-4768-961b-fdaea9088c73.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-N-[(1R,2S)-2,6-dimethyl-2,3-dihydro-1H-inden-1-yl]-6-(1-fluoroethyl)-1,3,5-triazine-2,4-diamine",950782-86-2,"OECD 409 subchronic, dog, gavage: NOAEL = 7.5 mg/kg bw/day; LOAEL = 15 mg/kg bw/day: STOT RE 2 (neurotoxicity) OECD 452 chronic (1y), dog, feed: NOAELmale/female = 2 mg/kg/day; LOAELmale/female = 6/7 mg/kg/day: STOT RE 2 (neurotoxicity) OECD 453 combined chronic/carcinogenicity (2y), rat, feed: NOAELmale/female = 12/17 mg/kg bw/day; LOAELmale/female = 118/167 mg/kg bw/day OECD 408 subchronic, rat, feed: NOAELmale/female = 338/410 mg/kg bw/day; LOAELmale/female = 689/809 mg/kg bw/day OECD 410 subacute, rat, dermal: NOAEL ≥ 1000 mg/kg bw/day ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/73ee5566-c5e4-4fed-a438-4a012b13bb70/documents/c89d30ef-3c75-48f8-8960-2715df5308e0_5d1a6a8c-9404-4290-b2b3-a26f1798c2d0.html,,,,,, "2-N-[(1R,2S)-2,6-dimethyl-2,3-dihydro-1H-inden-1-yl]-6-(1-fluoroethyl)-1,3,5-triazine-2,4-diamine",950782-86-2,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/73ee5566-c5e4-4fed-a438-4a012b13bb70/documents/c89d30ef-3c75-48f8-8960-2715df5308e0_5d1a6a8c-9404-4290-b2b3-a26f1798c2d0.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "2-N-[(1R,2S)-2,6-dimethyl-2,3-dihydro-1H-inden-1-yl]-6-(1-fluoroethyl)-1,3,5-triazine-2,4-diamine",950782-86-2,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/73ee5566-c5e4-4fed-a438-4a012b13bb70/documents/c89d30ef-3c75-48f8-8960-2715df5308e0_5d1a6a8c-9404-4290-b2b3-a26f1798c2d0.html,Chronic toxicity – systemic effects,oral,NOAEL,2 mg/kg bw/day,,dog "2-N-[(1R,2S)-2,6-dimethyl-2,3-dihydro-1H-inden-1-yl]-6-(1-fluoroethyl)-1,3,5-triazine-2,4-diamine",950782-86-2,"oral OECD 423, rat (limit test): LD50cut-off= 2500 mg/kg bw (mortality 1/6 after 4 days) dermal OECD 402, rat, 24 h, semiocclusive (limit test): LD50 > 2000 mg/kg bwinhalation OECD 403, rat, 4 h, nose only, aerosol (limit test): LC50 > 2300 mg/m³ (maximum technically attainable concentration with MMAD < 4 µm) ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73ee5566-c5e4-4fed-a438-4a012b13bb70/documents/ffa24239-cf89-40f2-b44a-c169b780a0c5_5d1a6a8c-9404-4290-b2b3-a26f1798c2d0.html,,,,,, "2-N-[(1R,2S)-2,6-dimethyl-2,3-dihydro-1H-inden-1-yl]-6-(1-fluoroethyl)-1,3,5-triazine-2,4-diamine",950782-86-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73ee5566-c5e4-4fed-a438-4a012b13bb70/documents/ffa24239-cf89-40f2-b44a-c169b780a0c5_5d1a6a8c-9404-4290-b2b3-a26f1798c2d0.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, "1,3,5-triisopropylbenzene",717-74-8," Under the test conditions for the repeated dose oral study, administration of the test item once daily to Wistar rats over a time period of 28 days (male) or 29 days (females) resulted in morphological findings in the liver of animals treated with 1000 mg/kg bw/day. The histopathological findings in the liver correlate with an increase of the liver weight (males and females), an increase in the blood cholesterol concentration (male and females) as well as an increase in the aspartate aminotransferase concentration (females). Combined, the several liver related findings point to an adverse effect of the test item at a concentration of 1000 mg/kg bw/day. Thus, a NOAEL at a concentration of 333 mg/kg bw/day is recommended. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c5ac3ab-fb09-4d50-b410-ed332a290ec1/documents/e2d7ede0-cb0e-4f61-ba06-bab04e9e33ab_3c1b5133-24e2-447d-bb23-707797d7bbc8.html,,,,,, "1,3,5-triisopropylbenzene",717-74-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c5ac3ab-fb09-4d50-b410-ed332a290ec1/documents/e2d7ede0-cb0e-4f61-ba06-bab04e9e33ab_3c1b5133-24e2-447d-bb23-707797d7bbc8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,333 mg/kg bw/day,,rat "1,3,5-triisopropylbenzene",717-74-8, The acute oral LD50 is > 2000 mg/kg bw. The acute inhalation (aerosol) 4h-LC50 is > 5.0 mg/L. The acute dermal LC50 is >2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c5ac3ab-fb09-4d50-b410-ed332a290ec1/documents/870cbbbe-2ab6-42c7-a5b4-efae3899cf72_3c1b5133-24e2-447d-bb23-707797d7bbc8.html,,,,,, "1,3,5-triisopropylbenzene",717-74-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c5ac3ab-fb09-4d50-b410-ed332a290ec1/documents/870cbbbe-2ab6-42c7-a5b4-efae3899cf72_3c1b5133-24e2-447d-bb23-707797d7bbc8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3,5-triisopropylbenzene",717-74-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c5ac3ab-fb09-4d50-b410-ed332a290ec1/documents/870cbbbe-2ab6-42c7-a5b4-efae3899cf72_3c1b5133-24e2-447d-bb23-707797d7bbc8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3,5-triisopropylbenzene",717-74-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c5ac3ab-fb09-4d50-b410-ed332a290ec1/documents/870cbbbe-2ab6-42c7-a5b4-efae3899cf72_3c1b5133-24e2-447d-bb23-707797d7bbc8.html,,inhalation,LC50,"5,000 mg/m3",adverse effect observed, "1,3,5-tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",52434-90-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ecf979ca-31e8-4759-bcb0-8dd702886243/documents/16aca9f6-7786-480d-a2ad-4b94c9ea7be0_b049c6f3-3878-44e1-bc6c-217e7846306b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,3,5-tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",52434-90-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecf979ca-31e8-4759-bcb0-8dd702886243/documents/208e228e-2bf3-4ce3-b4de-286f3f01f710_b049c6f3-3878-44e1-bc6c-217e7846306b.html,,oral,LD50,"> 16,000 mg/kg bw",no adverse effect observed, "1,3,5-tris(2,3-dibromopropyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",52434-90-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecf979ca-31e8-4759-bcb0-8dd702886243/documents/208e228e-2bf3-4ce3-b4de-286f3f01f710_b049c6f3-3878-44e1-bc6c-217e7846306b.html,,inhalation,LC50,> 5.03 mg/L,no adverse effect observed, "1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",27676-62-6,"Data are available from five separate assessments of toxicity; one 28-day toxicity test in rats, three 90-day toxicity studies in rats (which includes the key study) and one 90-day toxicity study in beagle dogs. In the key study, no relevant clinical symptoms and no signs of systemic toxicity were observed during the study. The mean bodyweight gain of all treated groups was considered comparable to the respective controls. The mean food and water consumption were also generally comparative to controls. Haemotology, urinalysis, pathology and histopathology all showed minor variations compared to controls but all within statistical variability and none gave rise to an indication of treatment related effects increased.NOAEL > 1000 mg/kg bw/day, actual volume based on the analytically found value in the diet ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ad73e65-e683-4c8c-91d3-5bca60728fc4/documents/IUC5-ad654285-b119-48fb-bbdc-358160970734_1c15e167-9cf9-4325-ad55-3ef0ce44f8d8.html,,,,,, "1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",27676-62-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ad73e65-e683-4c8c-91d3-5bca60728fc4/documents/IUC5-ad654285-b119-48fb-bbdc-358160970734_1c15e167-9cf9-4325-ad55-3ef0ce44f8d8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",27676-62-6,Acute oral and dermal toxicity determined using OECD test guideline 401 & 402.Oral LD50 > 5000 mg/kg bwDermal LD50 > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ad73e65-e683-4c8c-91d3-5bca60728fc4/documents/IUC5-2cdf9e96-b79c-4ac1-aa1c-6dd49e3958de_1c15e167-9cf9-4325-ad55-3ef0ce44f8d8.html,,,,,, "1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",27676-62-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ad73e65-e683-4c8c-91d3-5bca60728fc4/documents/IUC5-2cdf9e96-b79c-4ac1-aa1c-6dd49e3958de_1c15e167-9cf9-4325-ad55-3ef0ce44f8d8.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "1,3,5-tris(3,5-di-tert-butyl-4-hydroxybenzyl)-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",27676-62-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ad73e65-e683-4c8c-91d3-5bca60728fc4/documents/IUC5-2cdf9e96-b79c-4ac1-aa1c-6dd49e3958de_1c15e167-9cf9-4325-ad55-3ef0ce44f8d8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3,5-tris(3-mercaptopropyl)-1,3,5-triazinane-2,4,6-trione",78366-85-5," In an acute oral toxicity study (acute toxic class method, OECD 423), three groups of fasted, 8 - 9 weeks old, female Sprague-Dawley rats (3 rats/step) were given a single oral dose of 1,3,5-Tris-(3-mercaptopropyl)isocyanurate in corn oil at 300 (step 1 and 2) or 2000 mg/kg bw (step 3) and were observed for 14 days. Based on the results and in accordance with OECD guideline 423 the LD50 cut-off value was determined to be 500 mg/kg bw. Thus, the substance meets the criteria of the CLP regulation 1272/2008 for being classified as Acute Tox. 4, H302. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1f4413b-765f-470a-bda3-98de72ce57d6/documents/f5675884-3b49-4bd0-9d87-690c38745146_8b2aff21-689e-4042-bf6b-b905a5a6eb88.html,,,,,, "1,3,5-tris(3-mercaptopropyl)-1,3,5-triazinane-2,4,6-trione",78366-85-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1f4413b-765f-470a-bda3-98de72ce57d6/documents/f5675884-3b49-4bd0-9d87-690c38745146_8b2aff21-689e-4042-bf6b-b905a5a6eb88.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "1,3,5-tris[3-(trimethoxysilyl)propyl]-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",26115-70-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dfa55125-e43f-460c-9b23-45eab9a93238/documents/08822f3f-9711-4223-ae82-17d000d06bde_b693285f-7cf1-4635-b83d-2a200ec9e78c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "1,3,5-tris[3-(trimethoxysilyl)propyl]-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",26115-70-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfa55125-e43f-460c-9b23-45eab9a93238/documents/e12e0ccd-c088-450e-bcc3-afcb54176e79_b693285f-7cf1-4635-b83d-2a200ec9e78c.html,,oral,LD50,"1,713 mg/kg bw",adverse effect observed, "1,3,5-tris[3-(trimethoxysilyl)propyl]-1,3,5-triazine-2,4,6(1H,3H,5H)-trione",26115-70-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfa55125-e43f-460c-9b23-45eab9a93238/documents/e12e0ccd-c088-450e-bcc3-afcb54176e79_b693285f-7cf1-4635-b83d-2a200ec9e78c.html,,dermal,LD50,"> 19,200 mg/kg bw",no adverse effect observed, "1,3,6,8-Pyrenetetrasulfonic acid, sodium salt (1:4)",59572-10-0," Multiple Quantitative Structure Activity Relationship (QSAR) models were used to predict the the Acute Oral Toxicity of the test item Tetrasodium 1,3,6,8-pyrenetetrasulfonate. The final acute oral toxicity was predicted by applying a consensus method on the reliable results derived for individual models.The final Ready Biodegradability predicted for Tetrasodium 1,3,6,8-pyrenetetrasulfonateassigned by the study investigator: non readily biodegradable. Based on multiple QSAR models applied, the final Acute Oral Toxicity for Tetrasodium 1,3,6,8-pyrenetetrasulfonate was predicted as 170000 mg/kg/d (Oral Rat LD50). The final QSAR result can be associated with a Klimisch score: K2 The same method was used to predict the Acute Oral Toxicity of the analogue test item trisodium 8-hydroxypyrene-1,3,6-trisulfonate. The final acute oral toxicity predicted for trisodium 8-hydroxypyrene-1,3,6-trisulfonate assigned by the study investigator: LD50 58000 mg/kg/bw. Klimisch score assigned by the study investigtor for the final prediction: K2 Test results published on the ECHA website provided a LD50 of 15000 mg/kg/bw for Acute Oral Toxicity for the analogue test item trisodium 8-hydroxypyrene-1,3,6-trisulfonate. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7dc4c8a-c0b3-412d-9bba-a9a381bf9771/documents/4bca3411-ea34-4855-ba8e-3f0e509b3590_b7a0a527-1359-4069-9882-76410a5a7254.html,,,,,, "1,3,6,8-Pyrenetetrasulfonic acid, sodium salt (1:4)",59572-10-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7dc4c8a-c0b3-412d-9bba-a9a381bf9771/documents/4bca3411-ea34-4855-ba8e-3f0e509b3590_b7a0a527-1359-4069-9882-76410a5a7254.html,,oral,LD50,"170,000 mg/kg bw",no adverse effect observed, "1,3-Benzenediamine, 4-methyl-, reaction products with 4-nitrobenzenamine, p-phenylenediamine and sodium sulfide (Na2(Sx))",100208-66-0," Under the conditions of an OECD 422 compliant study, the the source substance Leuco Sulphur Yellow 22 (CAS 90268 -98 -7), used for cross-reading to Leuco Sulphur Brown 3 was administered at doses of 100, 300 or 1000 mg/kg bw/day (corrected doses; corresponding to uncorrected doses of 110.46, 331.38 and 1104.61 mg/kg bw/day, repsectively) by oral gavage to rats in an OECD 422 study. The substance did not cause signs of systemic toxicity and did not adversely influence the reproductive performance (gonad function, mating behavior, conception, parturition) in parental male and female rats. The development of the F1 offspring was not impaired from birth to post-natal day 13 at any dose level after repeated oral administration of dams. Based on these observations the No Observed Adverse Effect Levels (NOAEL) were determined as follows: NOAEL for systemic toxicity of male/female rats: 1000 mg/kg bw/day NOAEL for reproductive performance of male/ female rats: 1000 mg/kg bw/day NOAEL for F1 Offspring: 1000 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91dfbed9-5e17-4885-86f8-a0763a9948bf/documents/6bb11c95-75c5-4daa-8399-663476cb6754_c2f4bfd8-96f9-4cda-a0bc-7381fb937394.html,,,,,, "1,3-Benzenediamine, 4-methyl-, reaction products with 4-nitrobenzenamine, p-phenylenediamine and sodium sulfide (Na2(Sx))",100208-66-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91dfbed9-5e17-4885-86f8-a0763a9948bf/documents/6bb11c95-75c5-4daa-8399-663476cb6754_c2f4bfd8-96f9-4cda-a0bc-7381fb937394.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,3-Benzenediamine, 4-methyl-, reaction products with 4-nitrobenzenamine, p-phenylenediamine and sodium sulfide (Na2(Sx))",100208-66-0, The LD50 of the test item in the rat was found to be >2000 mg a.i./kg bw (corresponding to > 3640 mg/kg bw test item). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91dfbed9-5e17-4885-86f8-a0763a9948bf/documents/e70f92fc-959b-4e46-a6fe-ae90c75762f1_c2f4bfd8-96f9-4cda-a0bc-7381fb937394.html,,,,,, "1,3-Benzenediamine, 4-methyl-, reaction products with 4-nitrobenzenamine, p-phenylenediamine and sodium sulfide (Na2(Sx))",100208-66-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91dfbed9-5e17-4885-86f8-a0763a9948bf/documents/e70f92fc-959b-4e46-a6fe-ae90c75762f1_c2f4bfd8-96f9-4cda-a0bc-7381fb937394.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetates",84281-74-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b899e0c6-2fea-472b-a326-92591d4b10a6/documents/IUC5-637a6fed-b59a-42ff-b05d-f2ac777b7b59_62ca5eee-71dc-4794-89a7-697d797ecc6d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat "1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetates",84281-74-3,"LD50, oral, rat (m/f) ca. 3800 mg/kg bw /day (BASF, 1979)LD50, dermal, rat, (m/f) > 1000 mg/kg bw /day (BASF, 1979)LC50, inhalation, rat (m/f) > 5610 mg/m3 (BASF, 1978) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b899e0c6-2fea-472b-a326-92591d4b10a6/documents/IUC5-21a460e7-9413-48cb-b0c5-be189db99430_62ca5eee-71dc-4794-89a7-697d797ecc6d.html,,,,,, "1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetates",84281-74-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b899e0c6-2fea-472b-a326-92591d4b10a6/documents/IUC5-21a460e7-9413-48cb-b0c5-be189db99430_62ca5eee-71dc-4794-89a7-697d797ecc6d.html,,oral,LD50,"3,800 mg/kg bw",no adverse effect observed, "1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetates",84281-74-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b899e0c6-2fea-472b-a326-92591d4b10a6/documents/IUC5-21a460e7-9413-48cb-b0c5-be189db99430_62ca5eee-71dc-4794-89a7-697d797ecc6d.html,,dermal,LD50,"1,000 mg/kg bw",no adverse effect observed, "1,3-Benzenediamine, coupled with diazotized m-phenylenediamine, acetates",84281-74-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b899e0c6-2fea-472b-a326-92591d4b10a6/documents/IUC5-21a460e7-9413-48cb-b0c5-be189db99430_62ca5eee-71dc-4794-89a7-697d797ecc6d.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "1,3-Benzenedimethanamine, N-(2-phenylethyl) derivs.",404362-22-7,"From a valid subacute oral toxicity study with the rat a LOAEL of 50 mg/kg bw/d, and a NOAEL of 15 mg/kg bw/d resulted. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e729b31-5c2d-4e91-a185-149833449b36/documents/IUC5-e8581adf-d14d-4602-8ac8-648ff40f1e86_fdeeffaa-46be-408a-af49-e38edb807f4f.html,,,,,, "1,3-Benzenedimethanamine, N-(2-phenylethyl) derivs.",404362-22-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e729b31-5c2d-4e91-a185-149833449b36/documents/IUC5-e8581adf-d14d-4602-8ac8-648ff40f1e86_fdeeffaa-46be-408a-af49-e38edb807f4f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "1,3-Benzenedimethanamine, N-(2-phenylethyl) derivs.",404362-22-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e729b31-5c2d-4e91-a185-149833449b36/documents/IUC5-e8581adf-d14d-4602-8ac8-648ff40f1e86_fdeeffaa-46be-408a-af49-e38edb807f4f.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,2.99 mg/m3,,rat "1,3-Benzenedimethanamine, N-(2-phenylethyl) derivs.",404362-22-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e729b31-5c2d-4e91-a185-149833449b36/documents/IUC5-e8581adf-d14d-4602-8ac8-648ff40f1e86_fdeeffaa-46be-408a-af49-e38edb807f4f.html,Repeated dose toxicity – local effects,inhalation,LOAEC,0.15 mg/m3,adverse effect observed,rat "1,3-Benzenedimethanamine, N-(2-phenylethyl) derivs.",404362-22-7,"In an acute oral toxicity test, the LD50 was in the range between 500 and 2000 mg/kg. As the submission item turned out to be corrosive, no further acute testing was performed. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e729b31-5c2d-4e91-a185-149833449b36/documents/IUC5-bb504049-a70c-4c7c-86da-d75cfd187656_fdeeffaa-46be-408a-af49-e38edb807f4f.html,,,,,, "1,3-Benzenedimethanamine, N-(2-phenylethyl) derivs.",404362-22-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e729b31-5c2d-4e91-a185-149833449b36/documents/IUC5-bb504049-a70c-4c7c-86da-d75cfd187656_fdeeffaa-46be-408a-af49-e38edb807f4f.html,,oral,discriminating dose,500 mg/kg bw,adverse effect observed, "1,3-Benzenedimethanamine, reaction products with glycidyl tolyl ether",90194-04-0, The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 to  2000 mg/kg body weight (Globally Harmonized Classification System - Category 4). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc06ff73-df54-4382-ae2a-89f2bdc94e31/documents/1b9863cf-b8e1-45e3-b44d-63d3ab689037_ab85d728-57e5-4922-8c45-069776488fe0.html,,,,,, "1,3-Benzenedimethanamine, reaction products with glycidyl tolyl ether",90194-04-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc06ff73-df54-4382-ae2a-89f2bdc94e31/documents/1b9863cf-b8e1-45e3-b44d-63d3ab689037_ab85d728-57e5-4922-8c45-069776488fe0.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "1,3-Benzenedimethanamine, reaction products with polyetylene glycol mono-Bu ether and TDI",162568-25-4," In a Combined Repeated Dose Oral (Gavage) Toxicity Study with the Reproduction/Developmental Toxicity Screening Test with WS400517 in rats (OECD 422) at doses of 100, 300, and 1000 mg/kg bw/day with dosing for five consecutive weeks the NOEL was derived at 1000 mg/kg bw/day. In a sub-chronic oral (gavage) toxicity study the highest dose of WS400517 that practically could be administered to the animals was 600 mg/kg bw/day. This level was derived as NOAEL. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/683d1103-1b83-4716-ba04-641ec6e7eba7/documents/IUC5-09f16d0c-9189-42a3-be0f-1ea6d7420c47_137b35bd-bace-4b60-9ab1-ce39fbb79336.html,,,,,, "1,3-Benzenedimethanamine, reaction products with polyetylene glycol mono-Bu ether and TDI",162568-25-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/683d1103-1b83-4716-ba04-641ec6e7eba7/documents/IUC5-09f16d0c-9189-42a3-be0f-1ea6d7420c47_137b35bd-bace-4b60-9ab1-ce39fbb79336.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat "1,3-Benzenedimethanamine, reaction products with polyetylene glycol mono-Bu ether and TDI",162568-25-4,"Oral rat (standard acute method): LD50 > 2515 mg/kg bw (no mortality at 2515 mg/kg bw, dose extrapolated to neat WS400517)Dermal and inhalation rat studies were waived, as these studies were considered to be scientifically unjustified.Conclusion: No requirement of classification for acute oral, dermal or inhalation toxicity [Reg. (EC) 1272/2008]. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/683d1103-1b83-4716-ba04-641ec6e7eba7/documents/IUC5-cd339998-1606-4f5c-b823-0c6b35b7f98c_137b35bd-bace-4b60-9ab1-ce39fbb79336.html,,,,,, "1,3-Benzenedimethanamine, reaction products with polyetylene glycol mono-Bu ether and TDI",162568-25-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/683d1103-1b83-4716-ba04-641ec6e7eba7/documents/IUC5-cd339998-1606-4f5c-b823-0c6b35b7f98c_137b35bd-bace-4b60-9ab1-ce39fbb79336.html,,oral,LD50,"2,515 mg/kg bw",no adverse effect observed, "4-(4,6-Bis((biphenyl-4-yl)-1,3,5-triazine-2-yl)-1,3-benzodiole",182918-16-7,"Toxicity after repeated dose administration of the test substance was not assessed. Information on subchronic toxicity are derived from a strucutral analogue. In the course of a GLP conform subacute toxicity study, the test substance was administered daily by oral gavage to SPF-bred Wistar rats of both sexes at dose levels of 0, 50, 200 and 1000 mg/kg body weight/day for a period of 28 days according to the OECD guideline 407 (RCC Ltd, 2002). Administration of the test item did not induce mortalities, signs of treatment related toxicity or any other changes. A transient decrease in locomotor activity at high dose animals is regarded as an unspecific high dose effect. Thus the NOEL is considered to be 200 mg/kg bw /day and the NOAEL 1000 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ec4f0ce-0e62-43bd-bb48-b4a62c7c49e5/documents/IUC5-b5da36af-a157-48a1-9b3d-6140c53edddc_69e7cf28-e6cf-46f3-97aa-cead62a7fbd1.html,,,,,, "4-(4,6-Bis((biphenyl-4-yl)-1,3,5-triazine-2-yl)-1,3-benzodiole",182918-16-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ec4f0ce-0e62-43bd-bb48-b4a62c7c49e5/documents/IUC5-b5da36af-a157-48a1-9b3d-6140c53edddc_69e7cf28-e6cf-46f3-97aa-cead62a7fbd1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4-(4,6-Bis((biphenyl-4-yl)-1,3,5-triazine-2-yl)-1,3-benzodiole",182918-16-7,"The acute toxicity of the test substance was not assessed. Information on oral and dermal acute toxicity are derived from a strucutral analogue.The test item was applied oral and dermal to rats to evaluate the acute toxicity of the substance (GLP, OECD 423 and 402). LD50 after oral administration > 2000 mg/kg bw. Signs of toxicity were not observed. LD50 after dermal application> 2000 mg/kg bw. Signs of toxicity were not observed. A test on acute inhalative toxicity was not performed. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ec4f0ce-0e62-43bd-bb48-b4a62c7c49e5/documents/IUC5-1eb3e045-2947-46f6-a0c7-85b99816366e_69e7cf28-e6cf-46f3-97aa-cead62a7fbd1.html,,,,,, "4-(4,6-Bis((biphenyl-4-yl)-1,3,5-triazine-2-yl)-1,3-benzodiole",182918-16-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ec4f0ce-0e62-43bd-bb48-b4a62c7c49e5/documents/IUC5-1eb3e045-2947-46f6-a0c7-85b99816366e_69e7cf28-e6cf-46f3-97aa-cead62a7fbd1.html,,oral,LD50,"2,000 mg/kg bw",, "4-(4,6-Bis((biphenyl-4-yl)-1,3,5-triazine-2-yl)-1,3-benzodiole",182918-16-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ec4f0ce-0e62-43bd-bb48-b4a62c7c49e5/documents/IUC5-1eb3e045-2947-46f6-a0c7-85b99816366e_69e7cf28-e6cf-46f3-97aa-cead62a7fbd1.html,,dermal,LD50,"2,000 mg/kg bw",, "1,3-Benzenedisulfonic acid, 4,4'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]bis[6-[[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]azo]-, hexasodium salt",68991-98-0," Acute oral toxicity:  Acute oral toxicity dose (LD50) of hexasodium 4,4'-{ethene-1,2-diylbis[(3-sulfonato-4,1-phenylene)imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]}bis{6-[(5-carbamoyl-1-ethyl- 2-hydroxy-4-methyl-6-oxo- 1,6-dihydropyridin-3-yl)diazenyl]benzene-1,3-disulfonate} (CAS no: 68991-98-0) was predicted based on OECD QSAR toolbox 2933 mg/kg bw and different studies available on structurally similar read across substances 4,4'-bis[4,6-bis(anilino)-1,3,5-triazin-2-yl]aminostilbene-2,2'-disulphonic acid (CAS no: 88-38-0) >10000 mg/kg bw and 4,4'-bis[[6-anilino-4-(methylamino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonic acid (CAS no: 35632-99-6) >2500 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, hexasodium 4,4'-{ethene-1,2-diylbis[(3-sulfonato -4,1-phenylene)imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]}bis{6-[(5-carbamoyl-1-ethyl-2-hydroxy-4-methyl-6-oxo- 1,6-dihydropyridin-3-yl)diazenyl]benzene-1,3- disulfonate} cannot be classified for acute oral toxicity. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for hexasodium 4,4'-{ethene-1,2-diylbis[(3-sulfonato-4,1-phenylene)imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]}bis{6-[(5-carbamoyl-1- ethyl-2-hydroxy-4-methyl-6-oxo- 1,6-dihydropyridin-3-yl)diazenyl]benzene-1,3-disulfonate} (CAS no: 68991-98-0) was predicted based on OECD QSAR toolbox 9930 mg/kg bw and study available for the structurally similar read across substance 4,4'-bis[4,6-bis(anilino)-1,3,5-triazin-2-yl]aminostilbene-2,2'-disulphonic acid (CAS no: 88-38-0) >3000 mg/kg bw. Both these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, hexasodium 4,4'-{ethene-1,2-diylbis[(3-sulfonato-4,1-phenylene)imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]}bis{6-[(5-carbamoyl-1-ethyl-2-hydroxy-4-methyl-6-oxo- 1,6-dihydropyridin-3-yl)diazenyl]benzene-1,3-disulfonate} cannot be classified for acute dermal toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55663166-ce86-4639-8871-a1f33cfa7018/documents/5c55b71b-6bc9-4520-860b-f1ee0069dfc5_b08ad88f-1ead-465c-bf67-6712514be48b.html,,,,,, "1,3-Benzenedisulfonic acid, 4,4'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]bis[6-[[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]azo]-, hexasodium salt",68991-98-0,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55663166-ce86-4639-8871-a1f33cfa7018/documents/5c55b71b-6bc9-4520-860b-f1ee0069dfc5_b08ad88f-1ead-465c-bf67-6712514be48b.html,,oral,LD50,"2,933 mg/kg bw",no adverse effect observed, "1,3-Benzenedisulfonic acid, 4,4'-[1,2-ethenediylbis[(3-sulfo-4,1-phenylene)imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]bis[6-[[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]azo]-, hexasodium salt",68991-98-0,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55663166-ce86-4639-8871-a1f33cfa7018/documents/5c55b71b-6bc9-4520-860b-f1ee0069dfc5_b08ad88f-1ead-465c-bf67-6712514be48b.html,,dermal,LD50,"9,930 mg/kg bw",no adverse effect observed, "1,3-Benzenedisulfonic acid, 4-[[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]azo]-6-[[4-[[3-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-sulfophenyl]amino]-6-chloro-1,3,5-triazin-2-yl]amino]-",93941-80-1," Acute oral toxicity LD50 was estimated to be 28518.73 mg/kg bwmg/kg bw, when male and female Sprague-Dawley rats were exposed with 4-{[4-({3-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-sulfophenyl}amino)-6-chloro-1,3,5-triazin-2-yl]amino}-6-[(E)-2-(5-carbamoyl-1-ethyl-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridin-3-yl)diazen-1-yl]benzene-1,3-disulfonic acid (93941-80-1)orally. Acute dermal toxicity LD50 was estimated to be 20758.47 mg/kg bw. When male and female New Zealand White rabbits were exposed with 4-{[4-({3-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-sulfophenyl}amino)-6-chloro-1,3,5-triazin-2-yl]amino}-6-[(E)-2-(5-carbamoyl-1-ethyl-2-hydroxy-4-methyl-6-oxo-1,6-dihydropyridin-3-yl)diazen-1-yl]benzene-1,3-disulfonic acid (93941-80-1)by dermal application. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6051219-34ec-49b3-8c2a-e1020e0bce7d/documents/d74fdac0-de04-4607-afd8-d328c61c6e7a_a6683517-cdbc-48b0-a2fc-ca05fc0880a1.html,,,,,, "1,3-Benzenedisulfonic acid, 4-[[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]azo]-6-[[4-[[3-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-sulfophenyl]amino]-6-chloro-1,3,5-triazin-2-yl]amino]-",93941-80-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6051219-34ec-49b3-8c2a-e1020e0bce7d/documents/d74fdac0-de04-4607-afd8-d328c61c6e7a_a6683517-cdbc-48b0-a2fc-ca05fc0880a1.html,,oral,LD50,"28,518.73 mg/kg bw",no adverse effect observed, "1,3-Benzenedisulfonic acid, 4-[[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]azo]-6-[[4-[[3-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-sulfophenyl]amino]-6-chloro-1,3,5-triazin-2-yl]amino]-",93941-80-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6051219-34ec-49b3-8c2a-e1020e0bce7d/documents/d74fdac0-de04-4607-afd8-d328c61c6e7a_a6683517-cdbc-48b0-a2fc-ca05fc0880a1.html,,dermal,LD50,"20,758.47 mg/kg bw",no adverse effect observed, "1,3-Benzenedisulfonic acid, 4-[[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]azo]-6-[[4-[[3-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-sulfophenyl]amino]-6-chloro-1,3,5-triazin-2-yl]amino]-, trisodium salt",68110-27-0," According to the study results (acute toxic class method) the value of LD50 of the test substance, Reactive Blue 85, for female rats is higher than 2000 mg/kg of body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62f1f1bd-12f5-43a5-a152-8a0052451c1a/documents/2cd977f7-de17-4f1b-bb69-53410fd1c68b_7dd8d79d-7df3-4f40-a618-c07d4df3f44d.html,,,,,, "1,3-Benzenedisulfonic acid, 4-[[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]azo]-6-[[4-[[3-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-sulfophenyl]amino]-6-chloro-1,3,5-triazin-2-yl]amino]-, trisodium salt",68110-27-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62f1f1bd-12f5-43a5-a152-8a0052451c1a/documents/2cd977f7-de17-4f1b-bb69-53410fd1c68b_7dd8d79d-7df3-4f40-a618-c07d4df3f44d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3'-Bipyridinium, 5'-[[4-[[4-[(1',2'-dihydro-6'-hydroxy-3,4'-dimethyl-2'-oxo[1,3'-bipyridinium]-5'-yl)azo]benzoyl]amino]phenyl]azo]-1',2'-dihydro-6'-hydroxy-3,4'-dimethyl-2'-oxo-, salt with 2-hydroxypropanoic acid (1:2)",75214-63-0, NOAEL (28d) (male and female): 200 mg/kg bw ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dea607be-e570-484a-baf3-cd61ba808db8/documents/6aded0d6-c268-4b25-aff9-0271eafe337d_9b383e82-80a9-4087-8818-d623d98533ff.html,,,,,, "1,3'-Bipyridinium, 5'-[[4-[[4-[(1',2'-dihydro-6'-hydroxy-3,4'-dimethyl-2'-oxo[1,3'-bipyridinium]-5'-yl)azo]benzoyl]amino]phenyl]azo]-1',2'-dihydro-6'-hydroxy-3,4'-dimethyl-2'-oxo-, salt with 2-hydroxypropanoic acid (1:2)",75214-63-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dea607be-e570-484a-baf3-cd61ba808db8/documents/6aded0d6-c268-4b25-aff9-0271eafe337d_9b383e82-80a9-4087-8818-d623d98533ff.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "1,3'-Bipyridinium, 5'-[[4-[[4-[(1',2'-dihydro-6'-hydroxy-3,4'-dimethyl-2'-oxo[1,3'-bipyridinium]-5'-yl)azo]benzoyl]amino]phenyl]azo]-1',2'-dihydro-6'-hydroxy-3,4'-dimethyl-2'-oxo-, salt with 2-hydroxypropanoic acid (1:2)",75214-63-0, Oral LD50 (male and female) > 5000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dea607be-e570-484a-baf3-cd61ba808db8/documents/7b1b6b5f-cd0e-4154-94c2-cdc4da9ad461_9b383e82-80a9-4087-8818-d623d98533ff.html,,,,,, "1,3'-Bipyridinium, 5'-[[4-[[4-[(1',2'-dihydro-6'-hydroxy-3,4'-dimethyl-2'-oxo[1,3'-bipyridinium]-5'-yl)azo]benzoyl]amino]phenyl]azo]-1',2'-dihydro-6'-hydroxy-3,4'-dimethyl-2'-oxo-, salt with 2-hydroxypropanoic acid (1:2)",75214-63-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dea607be-e570-484a-baf3-cd61ba808db8/documents/7b1b6b5f-cd0e-4154-94c2-cdc4da9ad461_9b383e82-80a9-4087-8818-d623d98533ff.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "1,3-bis(1-isocyanato-1-methylethyl)benzene",2778-42-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3426fa0b-e00e-469d-b380-0d2788330148/documents/IUC5-d3c572a8-b330-4da9-ac4e-bc52c9b97ddd_f7ed7912-7d5c-49af-b710-69018cdf3f3e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "1,3-bis(1-isocyanato-1-methylethyl)benzene",2778-42-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3426fa0b-e00e-469d-b380-0d2788330148/documents/IUC5-d3c572a8-b330-4da9-ac4e-bc52c9b97ddd_f7ed7912-7d5c-49af-b710-69018cdf3f3e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4 mg/m3,adverse effect observed,rat "1,3-bis(1-isocyanato-1-methylethyl)benzene",2778-42-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3426fa0b-e00e-469d-b380-0d2788330148/documents/IUC5-c2fb698a-4967-408e-ada8-d307e281aeaf_f7ed7912-7d5c-49af-b710-69018cdf3f3e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "1,3-bis(1-isocyanato-1-methylethyl)benzene",2778-42-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3426fa0b-e00e-469d-b380-0d2788330148/documents/IUC5-c2fb698a-4967-408e-ada8-d307e281aeaf_f7ed7912-7d5c-49af-b710-69018cdf3f3e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3-bis(1-isocyanato-1-methylethyl)benzene",2778-42-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3426fa0b-e00e-469d-b380-0d2788330148/documents/IUC5-c2fb698a-4967-408e-ada8-d307e281aeaf_f7ed7912-7d5c-49af-b710-69018cdf3f3e.html,,inhalation,LC50,0 mg/m3,adverse effect observed, "1,3-bis(2,4,4-trimethylpentan-2-yl)trisulfane",98222-50-5," Repeated dose toxicity, rats: oral (female), 42 days - NOAEL = 30 mg/kg/day Repeated dose toxicity: inhalation - no study available Repeated dose toxicity: dermal - no study available ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ade02d6c-0985-4054-949b-b9b992accdb6/documents/36b36c0a-4c90-4f00-b8f1-d12ff0ad6be0_6db5d432-922b-4584-b5d6-7e5a09d9c92a.html,,,,,, "1,3-bis(2,4,4-trimethylpentan-2-yl)trisulfane",98222-50-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ade02d6c-0985-4054-949b-b9b992accdb6/documents/36b36c0a-4c90-4f00-b8f1-d12ff0ad6be0_6db5d432-922b-4584-b5d6-7e5a09d9c92a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "1,3-bis(2,4,4-trimethylpentan-2-yl)trisulfane",98222-50-5, Acute oral Toxicity: cute oral Toxicity: LD50 > 2000mg/kg body weight Acute dermal Toxicity: LD50 >2000mg/kg body weight ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ade02d6c-0985-4054-949b-b9b992accdb6/documents/e68adeff-2ca5-49cd-b32f-7dc20d82d0f0_6db5d432-922b-4584-b5d6-7e5a09d9c92a.html,,,,,, "1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene",119462-56-5, A 28-day oral gavage toxicity study resulted in a NOAEL of 50 mg/kg bw based on severe irritating effects of the test substance in the stomach. In a two generation feeding study on rats no such effects became obvious. The NOAEL in this study was 57 mg/kg in males and 71 mg/kg bw for females based on reduced body weight gain. In a 5-day rat pilot study with dermal application of the test substance severe skin reactions were seen starting after the third application or later. These effects may likely to be related to the skin sensitizing capacity of the test substance. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/15201c68-a82b-4cef-af16-7131283cb4e2/documents/IUC5-45bb8b4a-3c22-44a8-a653-a49c4f412e7b_fce620d6-78fd-4c5c-8a4a-023a0b2a41db.html,,,,,, "1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene",119462-56-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/15201c68-a82b-4cef-af16-7131283cb4e2/documents/IUC5-45bb8b4a-3c22-44a8-a653-a49c4f412e7b_fce620d6-78fd-4c5c-8a4a-023a0b2a41db.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,57 mg/kg bw/day,,rat "1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene",119462-56-5, LD50 oral: > 2000 mg/kg bw. LD50 dermal: > 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15201c68-a82b-4cef-af16-7131283cb4e2/documents/IUC5-b254ef4d-fb49-4c4f-a7c4-fae5047f749c_fce620d6-78fd-4c5c-8a4a-023a0b2a41db.html,,,,,, "1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene",119462-56-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15201c68-a82b-4cef-af16-7131283cb4e2/documents/IUC5-b254ef4d-fb49-4c4f-a7c4-fae5047f749c_fce620d6-78fd-4c5c-8a4a-023a0b2a41db.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,3-bis(3-methyl-2,5-dioxo-1H-pyrrolinylmethyl)benzene",119462-56-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15201c68-a82b-4cef-af16-7131283cb4e2/documents/IUC5-b254ef4d-fb49-4c4f-a7c4-fae5047f749c_fce620d6-78fd-4c5c-8a4a-023a0b2a41db.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,3-bis(trimethylsilyl)urea",18297-63-7,"Oral repeated dose toxicity, screening (OECD 422, rat, m/f):NOAEL systemic, males = 125 mg/kg bw/day (based on effect not relevant for humans)NOAEL systemic, females = 375 mg/kg bw/day (relevant for humans) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9638b1f-6548-4ad8-94b8-4904d67d1bfe/documents/343ae2e2-4b01-4897-9360-9bf178f1e91a_5028e0d7-3483-44a9-9c7a-e5a73dd7fb3c.html,,,,,, "1,3-bis(trimethylsilyl)urea",18297-63-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9638b1f-6548-4ad8-94b8-4904d67d1bfe/documents/343ae2e2-4b01-4897-9360-9bf178f1e91a_5028e0d7-3483-44a9-9c7a-e5a73dd7fb3c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,375 mg/kg bw/day,,rat "1,3-bis(trimethylsilyl)urea",18297-63-7,"Acute oral toxicity (OECD 420, rat, f): LD50 = > 300 < 2000 mg/kg bwAcute inhalation toxicity (OECD 433, rat, m/f): LC50 > 5.30 mg/L (aerosol) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9638b1f-6548-4ad8-94b8-4904d67d1bfe/documents/4a7b280d-fbfd-4e53-af9e-21d1644f798f_5028e0d7-3483-44a9-9c7a-e5a73dd7fb3c.html,,,,,, "1,3-bis(trimethylsilyl)urea",18297-63-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9638b1f-6548-4ad8-94b8-4904d67d1bfe/documents/4a7b280d-fbfd-4e53-af9e-21d1644f798f_5028e0d7-3483-44a9-9c7a-e5a73dd7fb3c.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, "1,3-bis(trimethylsilyl)urea",18297-63-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9638b1f-6548-4ad8-94b8-4904d67d1bfe/documents/4a7b280d-fbfd-4e53-af9e-21d1644f798f_5028e0d7-3483-44a9-9c7a-e5a73dd7fb3c.html,,inhalation,LC50,> 5.3 mg/L,no adverse effect observed, "1,3-bis[3-(dimethylamino)propyl]urea",52338-87-1," Oral administration of 3-DMAPAU to rats, bv gavage, at dose levels of 25, 250 and 500 mg/kg/dayv for twenty-eight consecutive days produced no toxicolocricallv significant changes in any of the treatment proups. The ""No Observed Effect Level (NOEL) was, therefore, considered to be 500 mg/kg/day. Based on the presence of approximately 15% of 1,3-bis[3-(dimethylamino)propyl]urea.(bisDMAPAU) in the test item, and according to the attached read-across justification this result is also deemed valid for 1,3-bis[3-(dimethylamino)propyl]urea (bisDMAPU). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/beabba4e-5237-4856-8411-4f12c7afeee4/documents/0d472738-03c1-4905-82cd-4788e3e7c824_48155d48-ff85-4396-92c8-911a3d7e07cd.html,,,,,, "1,3-bis[3-(dimethylamino)propyl]urea",52338-87-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/beabba4e-5237-4856-8411-4f12c7afeee4/documents/0d472738-03c1-4905-82cd-4788e3e7c824_48155d48-ff85-4396-92c8-911a3d7e07cd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "1,3-bis[3-(dimethylamino)propyl]urea",52338-87-1," The oral LD50 of 3-(dimethylamino)propylurea in rats was approximately 5125 mg/kg (5.0 ml/kg) of body weight. The dermal LD50 of 3-(dimethylamino)propylurea in rats is greater than 2050 mg/kg of body weight. Based on the presence of approximately 15% of 1,3-bis[3-(dimethylamino)propyl]urea.(bisDMAPAU) in the test item, and according to the attached read-across justification these results are also deemed valid for 1,3-bis[3-(dimethylamino)propyl]urea (bisDMAPU). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/beabba4e-5237-4856-8411-4f12c7afeee4/documents/8f4007b0-0b80-44de-b7ee-e47989bb6218_48155d48-ff85-4396-92c8-911a3d7e07cd.html,,,,,, "1,3-bis[3-(dimethylamino)propyl]urea",52338-87-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/beabba4e-5237-4856-8411-4f12c7afeee4/documents/8f4007b0-0b80-44de-b7ee-e47989bb6218_48155d48-ff85-4396-92c8-911a3d7e07cd.html,,oral,LD50,"5,125 mg/kg bw",no adverse effect observed, "1,3-bis[3-(dimethylamino)propyl]urea",52338-87-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/beabba4e-5237-4856-8411-4f12c7afeee4/documents/8f4007b0-0b80-44de-b7ee-e47989bb6218_48155d48-ff85-4396-92c8-911a3d7e07cd.html,,dermal,LD50,"2,050 mg/kg bw",no adverse effect observed, "4,4,4-trifluoro-1-(4-methylphenyl)butane-1,3-dione",720-94-5,Key study: Test method OECD 420. GLP study. The substance was classified as category 4 according to CLP Regulation (EC) no. 1272/2008 since the dose of 2000 mg/kg bw caused death in the sighting study. No effects were observed at 300 mg/kg bw (main study). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28efba48-7bec-407c-8807-baaf621827fb/documents/IUC5-87adc485-04fc-45d5-b53a-91841b5357df_0f6838fd-0ed8-4533-8142-19ab8420bb06.html,,,,,, "4,4,4-trifluoro-1-(4-methylphenyl)butane-1,3-dione",720-94-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28efba48-7bec-407c-8807-baaf621827fb/documents/IUC5-87adc485-04fc-45d5-b53a-91841b5357df_0f6838fd-0ed8-4533-8142-19ab8420bb06.html,,oral,discriminating dose,300 mg/kg bw,no adverse effect observed, "1,3-butylene diacetate",1117-31-3,"Based on read-across from Propane-1,2-diyl diacetate (CAS 623-84-7):Dermal: NOAEL (rat, m/f) > 1000 mg/kg bw/day (subacute) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65809d7d-55cf-45b2-9cf1-3d06691d5cb1/documents/0cd688c7-164f-45f2-840e-fe0281f79287_f869767f-ad4d-41bf-82ca-54a39e651d05.html,,,,,, "1,3-butylene diacetate",1117-31-3,"Based on read-across from Ethylene diacetate (CAS 111-55-7) and Propane-1,2-diyl diacetate (CAS 623-84-7):Oral: LD50 = 6860 mg/kg bwInhalation: LC0 = 0.845 mg/LDermal: LD50 > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65809d7d-55cf-45b2-9cf1-3d06691d5cb1/documents/fb34cccd-7b1e-44dd-8dee-5aee3754eb32_f869767f-ad4d-41bf-82ca-54a39e651d05.html,,,,,, "1,3-Cyclohexanedimethanamine",2579-20-6," Repeated dose toxicity, 42 days' dosing to rats (male and female); NOEL = 60 mg/kg/day Repeat dose toxicity by inhalation (13 weeks, 5 days per week, 6 hours per day) in male and female rats; NOAEL = 0.0586µg/L. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f71b2bb1-e449-42e6-a718-3f4c639fd74a/documents/IUC5-bca913dc-3d76-4fa3-a906-1f01c41b3e22_64be5124-9768-45b4-bf7f-86ba60db5061.html,,,,,, "1,3-Cyclohexanedimethanamine",2579-20-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f71b2bb1-e449-42e6-a718-3f4c639fd74a/documents/IUC5-bca913dc-3d76-4fa3-a906-1f01c41b3e22_64be5124-9768-45b4-bf7f-86ba60db5061.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat "1,3-Cyclohexanedimethanamine",2579-20-6," - Oral LD50, rats - LD50 between 300 and 2000 mg/kg.  LD50 reported as 700 mg/kg. - Dermal LD50, rabbits - LD50 = 1700 mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f71b2bb1-e449-42e6-a718-3f4c639fd74a/documents/IUC5-f34d7b53-887f-47a9-9964-a8b6643cac35_64be5124-9768-45b4-bf7f-86ba60db5061.html,,,,,, "1,3-Cyclohexanedimethanamine",2579-20-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f71b2bb1-e449-42e6-a718-3f4c639fd74a/documents/IUC5-f34d7b53-887f-47a9-9964-a8b6643cac35_64be5124-9768-45b4-bf7f-86ba60db5061.html,,oral,LD50,700 mg/kg bw,adverse effect observed, "1,3-Cyclohexanedimethanamine",2579-20-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f71b2bb1-e449-42e6-a718-3f4c639fd74a/documents/IUC5-f34d7b53-887f-47a9-9964-a8b6643cac35_64be5124-9768-45b4-bf7f-86ba60db5061.html,,dermal,LD50,"1,700 mg/kg bw",adverse effect observed, "N,N’-[cyclohexane-1,3-diylbis(methylene)]bis(2-methylpropan-1-imine)",173904-11-5,"Based on the results obtained from subacute repeated dose oral toxicity testing in rats a NOAEL of 609 mg/kg bw/day was determined. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study is conducted in accordance with GLP regulations and OECD/EU guideline. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6888def1-72b9-4c8e-9e32-0b391a78a51e/documents/844cc4f2-dc57-4478-bdd1-4d75eb13945e_fa30879a-326b-47b4-8ed4-3f640c965a34.html,,,,,, "N,N’-[cyclohexane-1,3-diylbis(methylene)]bis(2-methylpropan-1-imine)",173904-11-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6888def1-72b9-4c8e-9e32-0b391a78a51e/documents/844cc4f2-dc57-4478-bdd1-4d75eb13945e_fa30879a-326b-47b4-8ed4-3f640c965a34.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,609 mg/kg bw/day,,rat "N,N’-[cyclohexane-1,3-diylbis(methylene)]bis(2-methylpropan-1-imine)",173904-11-5,"Incorez 397 was tested for acute oral toxicity according to OECD Guideline 423/EU Method B.1 tris in a single oral dose of 2000 mg/kg bw in rats. No lethality was noted at single oral dose of 2000 mg/kg bw.Incorez 397 was tested for acute dermal toxicity in a limit test in rats according to OECD Guideline 402/EU Method B.3. Under the experimental conditions, the acute dermal LD50 value of the test item Incorez 397 proved to be greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats. On the other hand, it is to be noted that the test item caused dermal irritation response on the site of administration. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study was conducted in accordance with GLP regulations and OECD/EU guidelines. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study was conducted in accordance with GLP regulations and OECD/EU guidelines. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6888def1-72b9-4c8e-9e32-0b391a78a51e/documents/5db0f4fb-2e4d-41a7-8ed1-7286e5a2048b_fa30879a-326b-47b4-8ed4-3f640c965a34.html,,,,,, "N,N’-[cyclohexane-1,3-diylbis(methylene)]bis(2-methylpropan-1-imine)",173904-11-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6888def1-72b9-4c8e-9e32-0b391a78a51e/documents/5db0f4fb-2e4d-41a7-8ed1-7286e5a2048b_fa30879a-326b-47b4-8ed4-3f640c965a34.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N,N’-[cyclohexane-1,3-diylbis(methylene)]bis(2-methylpropan-1-imine)",173904-11-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6888def1-72b9-4c8e-9e32-0b391a78a51e/documents/5db0f4fb-2e4d-41a7-8ed1-7286e5a2048b_fa30879a-326b-47b4-8ed4-3f640c965a34.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3-Methoxy-18-methyl-8,14-seco-1,3,5(10),9(11)-estratetraene-14,17-dione",62298-52-6,"LD50 oral (rat): > 2000 mg/kg bw [Draft report, Kurth 1996]LD50 dermal (rat): > 2000 mg/kg bw [Draft report, Treher 1996a] ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d032e0bc-e5c5-4852-97a6-a3c4dffb6a0c/documents/IUC5-06575eae-1324-4806-99c3-02dc4ceb345f_88f0783c-cefc-410f-8658-6e20b9fc7f96.html,,,,,, "3-Methoxy-18-methyl-8,14-seco-1,3,5(10),9(11)-estratetraene-14,17-dione",62298-52-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d032e0bc-e5c5-4852-97a6-a3c4dffb6a0c/documents/IUC5-06575eae-1324-4806-99c3-02dc4ceb345f_88f0783c-cefc-410f-8658-6e20b9fc7f96.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3-Methoxy-18-methyl-8,14-seco-1,3,5(10),9(11)-estratetraene-14,17-dione",62298-52-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d032e0bc-e5c5-4852-97a6-a3c4dffb6a0c/documents/IUC5-06575eae-1324-4806-99c3-02dc4ceb345f_88f0783c-cefc-410f-8658-6e20b9fc7f96.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "sodium (5s,8s)-8-methoxy-2,4-dioxo-1,3-diazaspiro[4.5]decan-3-ide",1400584-86-2,"Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fdcaf09-2b60-4dc2-bff6-0bfe141e1e5a/documents/a3a61c53-885f-4323-bbb1-b64fb482313a_8ed831af-ca8d-41f8-a766-dcd35aa36966.html,,,,,, "sodium (5s,8s)-8-methoxy-2,4-dioxo-1,3-diazaspiro[4.5]decan-3-ide",1400584-86-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fdcaf09-2b60-4dc2-bff6-0bfe141e1e5a/documents/a3a61c53-885f-4323-bbb1-b64fb482313a_8ed831af-ca8d-41f8-a766-dcd35aa36966.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "sodium (5s,8s)-8-methoxy-2,4-dioxo-1,3-diazaspiro[4.5]decan-3-ide",1400584-86-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fdcaf09-2b60-4dc2-bff6-0bfe141e1e5a/documents/a3a61c53-885f-4323-bbb1-b64fb482313a_8ed831af-ca8d-41f8-a766-dcd35aa36966.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1,3-dibutyl-2-thiourea",109-46-6," No repeated toxicity study was available on 1,3 -dibutylthiourea. However two oral studies of 7 weeks in rats and mice were available in an analogue substance: 1,3 -diethylthiourea (DETU). The aim of these studies was to establish the maximum tolerated concentrations of DETU for administration to dosed animals in the chronic studies. Animals were exposed to DETU in diet during seven weeks to 147, 215, 316 and 464 ppm for rats, and 680, 1000, 1470, 2160 and 3150 ppm for mice. The target organ of DETU is the thyroid of rat. The LOAEL for thyroid toxicity is 6.25 mg/kg bw in rat (= 125 ppm). No target organ is showed in the mice. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/117f9d10-bc3c-4984-ae1c-9f6dd86a7be4/documents/598915ac-c345-4ac0-b83c-5bee7cb67c3b_2218f6d4-d22f-4621-967b-ae8d4caee1c0.html,,,,,, "1,3-dibutyl-2-thiourea",109-46-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/117f9d10-bc3c-4984-ae1c-9f6dd86a7be4/documents/598915ac-c345-4ac0-b83c-5bee7cb67c3b_2218f6d4-d22f-4621-967b-ae8d4caee1c0.html,Chronic toxicity – systemic effects,oral,LOAEL,6.25 mg/kg bw/day,,rat "1,3-dibutyl-2-thiourea",109-46-6," An oral acute study was performed on 1,3-dibutyl thiourea in rat. One animal died at 2000 mg/kg bw, so the LD50 is higher than 2000 mg/kg bw in rat by oral route. An acute dermal study is available on an analogue of 1,3-dibutyl thiourea in rat : 1,3-diethyl thiourea. In this study, the LD50 is equal to 2000 mg/kg bw. No data by inhalation is available. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/117f9d10-bc3c-4984-ae1c-9f6dd86a7be4/documents/IUC5-caaca5b2-beda-470c-aadf-90301e2293e8_2218f6d4-d22f-4621-967b-ae8d4caee1c0.html,,,,,, "1,3-dibutyl-2-thiourea",109-46-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/117f9d10-bc3c-4984-ae1c-9f6dd86a7be4/documents/IUC5-caaca5b2-beda-470c-aadf-90301e2293e8_2218f6d4-d22f-4621-967b-ae8d4caee1c0.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, "1,3-dibutyl-2-thiourea",109-46-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/117f9d10-bc3c-4984-ae1c-9f6dd86a7be4/documents/IUC5-caaca5b2-beda-470c-aadf-90301e2293e8_2218f6d4-d22f-4621-967b-ae8d4caee1c0.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "1,3-dichloro-4-nitrobenzene",611-06-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): guideline stuy under GLP conditions ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a5d5901-7dd0-4318-b3bf-1417513ee5f5/documents/IUC5-9f48bc51-6de5-408e-b63a-cba5d8b821d3_95dd6ed6-b510-431a-bc31-5526f8049c1f.html,,,,,, "1,3-dichloro-4-nitrobenzene",611-06-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a5d5901-7dd0-4318-b3bf-1417513ee5f5/documents/IUC5-9f48bc51-6de5-408e-b63a-cba5d8b821d3_95dd6ed6-b510-431a-bc31-5526f8049c1f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,8 mg/kg bw/day,,rat "1,3-dichloro-4-nitrobenzene",611-06-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The studies are performed similar to the respective guidelines Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): This is the only available study which was performed according to the respective guideline and GLP and evaluated with Klimisch Score 1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a5d5901-7dd0-4318-b3bf-1417513ee5f5/documents/IUC5-a55fd2a0-e955-440d-8a7a-967f22b2fb1f_95dd6ed6-b510-431a-bc31-5526f8049c1f.html,,,,,, "1,3-dichloro-4-nitrobenzene",611-06-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a5d5901-7dd0-4318-b3bf-1417513ee5f5/documents/IUC5-a55fd2a0-e955-440d-8a7a-967f22b2fb1f_95dd6ed6-b510-431a-bc31-5526f8049c1f.html,,oral,LD50,379 mg/kg bw,adverse effect observed, "1,3-dichloro-4-nitrobenzene",611-06-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a5d5901-7dd0-4318-b3bf-1417513ee5f5/documents/IUC5-a55fd2a0-e955-440d-8a7a-967f22b2fb1f_95dd6ed6-b510-431a-bc31-5526f8049c1f.html,,dermal,LD50,921 mg/kg bw,adverse effect observed, "1,3-dichloro-5,5-dimethylhydantoin",118-52-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Data reported by Health Council of the Netherlands in the document ""Committee on Updating of Occupational Exposure Limits. 1,3-Dichloro-5,5-dimethylhydantoin, 2000/15OSH/046, 31 October 2002"" ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7203b08f-811a-49f4-b549-22fecd6ea491/documents/ccd0ae97-7829-49ea-bbc4-77cef6bdf31c_b873c904-f301-432a-be06-22bb06585c9d.html,,,,,, "1,3-dichloro-5,5-dimethylhydantoin",118-52-5," The acute toxicity data available for 1,3-dichloro-5,5-dimethylhydantoin are: LD50 rat oral = 542 mg/kg/bw, LD50 inhalation rat 1h = 20.5 g/m3 and LD50 dermal rabbit > 20000 mg/kg/bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7203b08f-811a-49f4-b549-22fecd6ea491/documents/ccab00fb-5fc5-44e8-ac52-2c6cee1042c7_b873c904-f301-432a-be06-22bb06585c9d.html,,,,,, "1,3-dichloro-5,5-dimethylhydantoin",118-52-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7203b08f-811a-49f4-b549-22fecd6ea491/documents/ccab00fb-5fc5-44e8-ac52-2c6cee1042c7_b873c904-f301-432a-be06-22bb06585c9d.html,,oral,LD50,542 mg/kg bw,adverse effect observed, "1,3-dichloro-5,5-dimethylhydantoin",118-52-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7203b08f-811a-49f4-b549-22fecd6ea491/documents/ccab00fb-5fc5-44e8-ac52-2c6cee1042c7_b873c904-f301-432a-be06-22bb06585c9d.html,,dermal,LD50,"20,000 mg/kg bw",no adverse effect observed, "1,3-dichloro-5,5-dimethylhydantoin",118-52-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7203b08f-811a-49f4-b549-22fecd6ea491/documents/ccab00fb-5fc5-44e8-ac52-2c6cee1042c7_b873c904-f301-432a-be06-22bb06585c9d.html,,inhalation,LC50,"20,500 mg/m3",, "1,3-dichlorobenzene",541-73-1,Valid acute oral and acute inhalation toxicity studies are available. A dermal study is not required because a reliable oral and inhalation study is on hand. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28768cb9-ee0c-46b7-83eb-b4fc42d656a0/documents/IUC5-ff608d46-afe5-4ab1-97c4-d446425d0eb7_15661505-0222-4003-872c-4e1c3de26282.html,,,,,, "1,3-dichlorobenzene",541-73-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28768cb9-ee0c-46b7-83eb-b4fc42d656a0/documents/IUC5-ff608d46-afe5-4ab1-97c4-d446425d0eb7_15661505-0222-4003-872c-4e1c3de26282.html,,oral,LD50,580 mg/kg bw,adverse effect observed, "1,3-dichlorobenzene",541-73-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28768cb9-ee0c-46b7-83eb-b4fc42d656a0/documents/IUC5-ff608d46-afe5-4ab1-97c4-d446425d0eb7_15661505-0222-4003-872c-4e1c3de26282.html,,inhalation,discriminating conc.,"17,600 mg/m3",adverse effect observed, "1,3-dichlorobut-2-ene",926-57-8,"-Acute toxicity: oral: LD50=414 mg/kg bw (male rats); LD50=300 mg/kg bw (female rats) according to OECD TG 401-Acute Toxicity: inhalation: LD50=546 ppm (male rats), no guideline followed ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1e300c7-9c31-4315-b3aa-7ec68dda54c1/documents/IUC5-f5982086-8945-4da3-8783-68019a44814f_f127a5f1-f226-49bb-bb05-74d7f2935fb0.html,,,,,, "1,3-diisocyanato-3,5-Diethyl-6-methyl-benzene",2162-70-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc62ae08-8491-457a-874f-22ae57ca51d5/documents/720a938d-aa6c-4dd3-866d-fcd8f0c49e66_ade5971c-cdf7-4a29-a33e-47aa0df4f5f5.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1,3-diethyl-2-thiourea",105-55-5,"Two oral studies of 7 weeks in rats and mice are available, there are two range finding tests for carcinogenicity tests. The aim of these studies was to establish the maximum tolerated concentrations of DETU for administration to dosed animals in the chronic studies. Animals were exposed to DETU in diet during seven weeks to 147, 215, 316 and 464 ppm for rats, and 680, 1000, 1470, 2160 and 3150 ppm for mice. The target organ of DETU is the thyroid of rat. The LOAEL for thyroid toxicity is 6.25 mg/kg bw in rat (= 125 ppm).No target organ is showed in the mice.   A Decision on Compliance Check was received requesting a Screening for reproductive/developmental toxicity on rats (OECD 422) followed by a Sub-chronic toxicity study (90-day) on rats (OECD 408) to be conducted on the registered substance. The deadline for providing the finalised study is: 20 February 2023.Before initiating the OECD 422, it was considered appropriate to conduct a 14-day Dose Range Finding study. The aim was to generate appropriate experimental data on the registered substance in order to select the most appropriate dose-levels to be investigated during the OECD 422. Results of the OECD 422 were to be used to select the most appropriate dose-levels during the subsequent OECD 408, in accordance with the latest ECHA Guidance. Due to unforeseen circumstances, delays were encountered resulting in the postponement of the studies. Consequently, the regulatory deadline cannot be met. Testing schedule is reported in the associated RSS. Results will be provided as soon as they will be available. . Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Reliable study (klimish score of 2) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5014f549-558d-4505-a1e3-3b22ba1f6458/documents/IUC5-4a87c3ca-8ed1-442c-bb80-5335fdf708d7_c9112e3c-206a-451f-82fa-3c2f094c19f8.html,,,,,, "1,3-diethyl-2-thiourea",105-55-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5014f549-558d-4505-a1e3-3b22ba1f6458/documents/IUC5-4a87c3ca-8ed1-442c-bb80-5335fdf708d7_c9112e3c-206a-451f-82fa-3c2f094c19f8.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,6.25 mg/kg bw/day,,rat "1,3-diethyl-2-thiourea",105-55-5,"A reliable study on rats is available for oral route. Mortalities were observed at several doses, and the LD50 was 930 mg/kg bw in mice.By dermal route, a guideline study (OECD 402) is available on rats. The dermal LD50 of DETU is equal to 2000 mg/kg bw. There are no data on acute toxicity by inhalation. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5014f549-558d-4505-a1e3-3b22ba1f6458/documents/IUC5-4bced250-fdec-429b-bd2c-7a9008f4fcc3_c9112e3c-206a-451f-82fa-3c2f094c19f8.html,,,,,, "1,3-diethyl-2-thiourea",105-55-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5014f549-558d-4505-a1e3-3b22ba1f6458/documents/IUC5-4bced250-fdec-429b-bd2c-7a9008f4fcc3_c9112e3c-206a-451f-82fa-3c2f094c19f8.html,,oral,LD50,930 mg/kg bw,adverse effect observed, "1,3-diethyl-2-thiourea",105-55-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5014f549-558d-4505-a1e3-3b22ba1f6458/documents/IUC5-4bced250-fdec-429b-bd2c-7a9008f4fcc3_c9112e3c-206a-451f-82fa-3c2f094c19f8.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "1,3-diethyldiphenylurea",85-98-3,The value of NOAEL is 50 mg/kg bw/day for males and 150 mg/kg bw/day for females. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ecc55a07-7f7d-4361-b15c-165f1344d1b8/documents/IUC5-55f2115e-1dad-4abd-9379-07d3a9c9c1c8_ec633107-2e5f-4115-9ad6-0b34c07d31ac.html,,,,,, "1,3-diethyldiphenylurea",85-98-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ecc55a07-7f7d-4361-b15c-165f1344d1b8/documents/IUC5-55f2115e-1dad-4abd-9379-07d3a9c9c1c8_ec633107-2e5f-4115-9ad6-0b34c07d31ac.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "1,3-diethyldiphenylurea",85-98-3,"Acute oral toxicity: EU Method B.1, GLP. Adverse effect was observed. Therefore, the acute oral toxicity of Ethyl centralite is moderate.Acute dermal toxicity: EU Method B.3, GLP. No adverse effect was observed. Therefore, the acute dermal toxicity of Ethyl centralite is low.Acute inhalation toxicity: Toxicology Division Procedural Guide USAEHA. No adverse effect was observed. Therefore, the acute inhalation toxicity of Ethyl centralite is low. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecc55a07-7f7d-4361-b15c-165f1344d1b8/documents/IUC5-c7b6d84e-cbe9-4830-acfb-d0eb2519e7d3_ec633107-2e5f-4115-9ad6-0b34c07d31ac.html,,,,,, "1,3-diethyldiphenylurea",85-98-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecc55a07-7f7d-4361-b15c-165f1344d1b8/documents/IUC5-c7b6d84e-cbe9-4830-acfb-d0eb2519e7d3_ec633107-2e5f-4115-9ad6-0b34c07d31ac.html,,oral,LD50,780.9 mg/kg bw,adverse effect observed, "1,3-diethyldiphenylurea",85-98-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecc55a07-7f7d-4361-b15c-165f1344d1b8/documents/IUC5-c7b6d84e-cbe9-4830-acfb-d0eb2519e7d3_ec633107-2e5f-4115-9ad6-0b34c07d31ac.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3-diethyldiphenylurea",85-98-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecc55a07-7f7d-4361-b15c-165f1344d1b8/documents/IUC5-c7b6d84e-cbe9-4830-acfb-d0eb2519e7d3_ec633107-2e5f-4115-9ad6-0b34c07d31ac.html,,inhalation,LC50,"198,000 mg/m3",no adverse effect observed, "1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione",53988-10-6," MB2 (2-mercaptomethylbenzimidazole, CAS n° 53988 -10 -6): Male and female rats were treated orally by gavage with 2-mercaptomethylbenzimidazole at doses of 0 (corn oil), 4, 20 and 100 mg/kg bw for 28 consecutive days. Clinical signs, body weight, food consumption, organ weights, clinical biochemistry and hematological parameters were recorded and a histopathological examination was conducted. No repeated dose studies for inhalation and dermal toxicity are available Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint: The most reliable study for the determinatin of a NOAEL was used as key study and for classification ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c63fb214-c977-4b83-8f51-c1ea08110c40/documents/IUC5-dd4f6d4e-954a-4780-b3a0-37c3b92807ed_bef4cb60-ee53-4dbb-b9bd-6628d36fdc1f.html,,,,,, "1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione",53988-10-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c63fb214-c977-4b83-8f51-c1ea08110c40/documents/IUC5-dd4f6d4e-954a-4780-b3a0-37c3b92807ed_bef4cb60-ee53-4dbb-b9bd-6628d36fdc1f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione",53988-10-6,"In 2 valid oral toxicity studies with 2-mercaptomethylbenzimidazole a LD50 = 340 mg/kg bw (rat, male) (Loeser) and a LD50 = 330 mg/kg bw (rat, male/female) (Saitoh) was found. In an acute oral toxicity study with the corresponding zinc salt (2-mercaptomethylbenzimidazole, zinc salt CAS no 61617-00-3) a LD50 = 390 mg/kg bw was determined.Acute inhalative toxicity was tested with methyl-2-mercaptobenzimidazole, zinc salt in male and female Sprague-Dawley rats. Rats were exposed nose only for 4 hours at room temperature to a concentration of 0 and 2120 mg/m³. No mortality was observed. A valid study with methyl-2-mercaptobenzimidazole, zinc salt for dermal toxicity determined a LD50 > 2000 mg/kg bw. At 2000 mg/kg bw none of 10 animals died. Justification for read across of 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione, zinc salt and 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione:The toxicological properties of 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione (CAS n° 53988-10-6) and 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione, zinc salt (CAS n° 61617-00-3) are quite similar in toxicological studies available for both compounds (e.g. acute toxicity, irritation/corrosion, genotoxicity, repeated dose studies). This result is assumed to be an effect of the of 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione anion rather than of the hydronium ion (which is a normal constituent of body fluids) or zinc cation, which is an essential element in humans. Therefore a read across between 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione (CAS n° 53988-10-6) and its sodium salt (CAS n° 75045-07-7) and 1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione, zinc salt (CAS n° 61617-00-3) is justified. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c63fb214-c977-4b83-8f51-c1ea08110c40/documents/IUC5-0c7e30d0-3a20-4f99-8304-dfae244e2992_bef4cb60-ee53-4dbb-b9bd-6628d36fdc1f.html,,,,,, "1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione",53988-10-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c63fb214-c977-4b83-8f51-c1ea08110c40/documents/IUC5-0c7e30d0-3a20-4f99-8304-dfae244e2992_bef4cb60-ee53-4dbb-b9bd-6628d36fdc1f.html,,oral,LD50,340 mg/kg bw,adverse effect observed, "1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione",53988-10-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c63fb214-c977-4b83-8f51-c1ea08110c40/documents/IUC5-0c7e30d0-3a20-4f99-8304-dfae244e2992_bef4cb60-ee53-4dbb-b9bd-6628d36fdc1f.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione",53988-10-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c63fb214-c977-4b83-8f51-c1ea08110c40/documents/IUC5-0c7e30d0-3a20-4f99-8304-dfae244e2992_bef4cb60-ee53-4dbb-b9bd-6628d36fdc1f.html,,inhalation,discriminating conc.,"2,120 mg/m3",, "1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione, zinc salt",61617-00-3,A Combined Repeated Dose Toxicity Study study with the Reproductive/Developmental Toxicity Screening Test (OECD TG 422) in rats by the oral route (dietary) of ZMB2 resulted in repeated dose LOAEL value of 60 mgkg/day. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f103e1b3-39b6-4c3d-a36f-30d807b33ba1/documents/833323ff-fb2d-4e27-9b1a-2e5172f96aaa_ad3eeaec-8f98-4dbd-a8fc-50bcf2d2d099.html,,,,,, "1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione, zinc salt",61617-00-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f103e1b3-39b6-4c3d-a36f-30d807b33ba1/documents/833323ff-fb2d-4e27-9b1a-2e5172f96aaa_ad3eeaec-8f98-4dbd-a8fc-50bcf2d2d099.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,60 mg/kg bw/day,,rat "1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione, zinc salt",61617-00-3,"Acute toxicity: oralLD50 of ZMB2 is 800 mg/kg (Bioscience Incorporated, 1977).Acute toxicity: dermalLD50 of ZMB2 is >2000 mg/kg bodyweight (Safepharm, 2002).Acute toxicity: inhalationLC50 of ZMB2 is >2.12 mg/L (Safepharm, 2003). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f103e1b3-39b6-4c3d-a36f-30d807b33ba1/documents/94982159-8192-4741-ac96-45cfec6bbe66_ad3eeaec-8f98-4dbd-a8fc-50bcf2d2d099.html,,,,,, "1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione, zinc salt",61617-00-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f103e1b3-39b6-4c3d-a36f-30d807b33ba1/documents/94982159-8192-4741-ac96-45cfec6bbe66_ad3eeaec-8f98-4dbd-a8fc-50bcf2d2d099.html,,oral,LD50,800 mg/kg bw,adverse effect observed, "1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione, zinc salt",61617-00-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f103e1b3-39b6-4c3d-a36f-30d807b33ba1/documents/94982159-8192-4741-ac96-45cfec6bbe66_ad3eeaec-8f98-4dbd-a8fc-50bcf2d2d099.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3-dihydro-4(or 5)-methyl-2H-benzimidazole-2-thione, zinc salt",61617-00-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f103e1b3-39b6-4c3d-a36f-30d807b33ba1/documents/94982159-8192-4741-ac96-45cfec6bbe66_ad3eeaec-8f98-4dbd-a8fc-50bcf2d2d099.html,,inhalation,LC50,"2,120 mg/m3",no adverse effect observed, "1,3-diiodopropane",627-31-6," The LD50 of the test item 1,3-Diiodopropane is greater than 300 mg/kg and lower than 2000 mg/kg body weight after single oral administration to Wistar rats. Thus, the substance 1,3-Diiodopropane is classified in GHS Category 4 with a LD50 cut off value 500 mg/kg body weight, after single oral administration to Wistar rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be9a7eda-5147-4366-abc4-e08852e78794/documents/36c8b605-8fee-4e72-823e-28f3afd54090_10aed8d3-477d-4232-9cc0-c43276dde170.html,,,,,, "1,3-diiodopropane",627-31-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be9a7eda-5147-4366-abc4-e08852e78794/documents/36c8b605-8fee-4e72-823e-28f3afd54090_10aed8d3-477d-4232-9cc0-c43276dde170.html,,oral,discriminating dose,500 mg/kg bw,adverse effect observed, "1,3-diisopropylbenzene",99-62-7,"Repeated dose toxicity oral According to the OECD guideline 408, GLP compliance, NOAEL (systemic): 300 mg/kg/day  ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc1e3c8b-f2d0-408a-84e4-0cabd82bb772/documents/a5e093be-db67-438a-bc57-c52b0b645166_5a44ad07-9eca-4a0c-9f80-ab9ecfe26c91.html,,,,,, "1,3-diisopropylbenzene",99-62-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc1e3c8b-f2d0-408a-84e4-0cabd82bb772/documents/a5e093be-db67-438a-bc57-c52b0b645166_5a44ad07-9eca-4a0c-9f80-ab9ecfe26c91.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "1,3-diisopropylbenzene",99-62-7,"Acute toxicity – oral/ rats Slightly toxic in oral route. LD50 > 5000 mg/kg body weight.   Acute toxicity – inhalation Not considered to be a relevant route of potential human exposure Acute toxicity – dermal/ guinea pigs Slightly toxic by the dermal route, LD50 > 20 mL/kg bw/d (= ca. 20000 mg/kg bw/d). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc1e3c8b-f2d0-408a-84e4-0cabd82bb772/documents/78895dbb-d0eb-4854-bd7e-d88ede97079b_5a44ad07-9eca-4a0c-9f80-ab9ecfe26c91.html,,,,,, "1,3-diisopropylbenzene",99-62-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc1e3c8b-f2d0-408a-84e4-0cabd82bb772/documents/78895dbb-d0eb-4854-bd7e-d88ede97079b_5a44ad07-9eca-4a0c-9f80-ab9ecfe26c91.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "1,3-diisopropylbenzene",99-62-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc1e3c8b-f2d0-408a-84e4-0cabd82bb772/documents/78895dbb-d0eb-4854-bd7e-d88ede97079b_5a44ad07-9eca-4a0c-9f80-ab9ecfe26c91.html,,dermal,LD50,"> 20,000 mg/kg bw",no adverse effect observed, "1,3-Dimethoxyphthalan",24388-70-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31cf7503-6068-4c43-b36a-5634aef9f34a/documents/49e0dd2a-3fdf-4f66-be24-c7aa8eb7b4b2_dce2e809-3824-4a6b-ba6b-1ec9cccd35b2.html,,oral,LD50,133 mg/kg bw,adverse effect observed, "1,3-dimethyl-1,3-diphenylurea",611-92-7," The read-across substance, Ethyl centralite, was tested for subchronic toxicity using the method B.26. Sub-Chronic Oral Toxicity Test: Repeated Dose 90-day Oral Toxicity Study in Rodents, Council Regulation (EC) No. 440/2008, Published in O.J. L142, 2008. The value of NOAEL was determined on the base of following findings in 90-days repeated dose toxicity study: microscopical examination (early stage of chronic progressive nephropathy of kidneys in males), haematological examination (changes of value of total erythrocyte count and value of haemoglobin in females), biochemical examination (changes of values of chloride ions, calcium ions, inorganic phosphorus, protein total, albumin, bile acids, cholinesterase and activity of ALP in males, changes of value of triglycerides and activity of AST in females) and biometry of organs (changes of weight of kidneys, liver in males and weight of liver in females). The value of NOAEL is 50 mg/kg bw/day for males and 150 mg/kg bw/day for females. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/499615ac-5e5f-409b-b5f5-65e79ba15f63/documents/f57ddebe-04ef-4361-aa5d-6ce9c979dbdf_9b80e26c-8487-44f1-96da-9e178dd61184.html,,,,,, "1,3-dimethyl-1,3-diphenylurea",611-92-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/499615ac-5e5f-409b-b5f5-65e79ba15f63/documents/f57ddebe-04ef-4361-aa5d-6ce9c979dbdf_9b80e26c-8487-44f1-96da-9e178dd61184.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "1,3-dimethyl-1,3-diphenylurea",611-92-7," Only one study is available. The testing was performed according Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008. GLP study. Klimish score 1. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/499615ac-5e5f-409b-b5f5-65e79ba15f63/documents/94e15896-c0f3-4863-b187-3e074f98809a_9b80e26c-8487-44f1-96da-9e178dd61184.html,,,,,, "1,3-dioxepane",505-65-7,In a 28 day oral study in rats no treatment related effects were observed up to the limit dose of 1000mg/kg bw. ,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a88972d-0296-483c-a9aa-2d3021a3d948/documents/IUC5-d7819ce9-7171-4594-9df6-d610d5b19feb_14dd4b04-6c49-44c3-9d0e-c6f3478159ba.html,,,,,, "1,3-dioxepane",505-65-7,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a88972d-0296-483c-a9aa-2d3021a3d948/documents/IUC5-d7819ce9-7171-4594-9df6-d610d5b19feb_14dd4b04-6c49-44c3-9d0e-c6f3478159ba.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,3-dioxepane",505-65-7,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a88972d-0296-483c-a9aa-2d3021a3d948/documents/IUC5-d7819ce9-7171-4594-9df6-d610d5b19feb_14dd4b04-6c49-44c3-9d0e-c6f3478159ba.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"3,000 mg/m3",,rat "1,3-dioxepane",505-65-7,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a88972d-0296-483c-a9aa-2d3021a3d948/documents/IUC5-d7819ce9-7171-4594-9df6-d610d5b19feb_14dd4b04-6c49-44c3-9d0e-c6f3478159ba.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"3,000 mg/m3",adverse effect observed,rat "1,3-dioxepane",505-65-7,Acute oral LD50 in rats: 4523 mg/kg bw. Acute inhalation LC50 in rats >20.8 mg/l. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a88972d-0296-483c-a9aa-2d3021a3d948/documents/IUC5-3293950a-6b56-425d-a3c8-dbeafcef2de6_14dd4b04-6c49-44c3-9d0e-c6f3478159ba.html,,,,,, "1,3-dioxepane",505-65-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a88972d-0296-483c-a9aa-2d3021a3d948/documents/IUC5-3293950a-6b56-425d-a3c8-dbeafcef2de6_14dd4b04-6c49-44c3-9d0e-c6f3478159ba.html,,oral,LD50,"4,523 mg/kg bw",, "4,5-Dichloro-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolane",161611-73-0," One study is available (Tos, 1995). In this test Sprague-Dawley of both sexes were exposed to a limit dose of 2000 mg/kg). The study was performed according to OECD 401 and under GLP principles. No mortality and no clinical signs were observed. No gross pathological findings were reported. The LD50 was estimated to be > 2000 mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d668d88-b9cd-430d-892c-71a991e94e07/documents/1d650fbe-e822-40f7-9c36-fdf513e66866_a886f093-60b2-427c-8453-144575c441a2.html,,,,,, "4,5-Dichloro-2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolane",161611-73-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d668d88-b9cd-430d-892c-71a991e94e07/documents/1d650fbe-e822-40f7-9c36-fdf513e66866_a886f093-60b2-427c-8453-144575c441a2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxole",161611-74-1," Acute inhalation toxicity: LC50 > 20mg/L (= 20000 mg/m3) (OECD 403, K, Rel.1) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa768668-bc41-4252-8abb-5d18baf03b61/documents/b38d3171-b668-48b2-8047-3f7add958dce_2e69389f-1e65-47f5-acfb-a8cdcae3380a.html,,,,,, "2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxole",161611-74-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa768668-bc41-4252-8abb-5d18baf03b61/documents/b38d3171-b668-48b2-8047-3f7add958dce_2e69389f-1e65-47f5-acfb-a8cdcae3380a.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, "1,3-diphenyl-2-thiourea",102-08-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The Rokh' study is reliable with a klimisch score of 1. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6df92cb4-5fc9-4e32-961a-a4ff5ca24560/documents/IUC5-00207fb6-ec5e-400a-be71-7c660b54ca9b_97b9d641-d717-498d-a195-ac00cd3f3e75.html,,,,,, "1,3-diphenyl-2-thiourea",102-08-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6df92cb4-5fc9-4e32-961a-a4ff5ca24560/documents/IUC5-00207fb6-ec5e-400a-be71-7c660b54ca9b_97b9d641-d717-498d-a195-ac00cd3f3e75.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "1,3-diphenyl-2-thiourea",102-08-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Bombard's study is a reliable study with a klimisch score of 1. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Queudot's study is a reliable study with a klimisch score of 1. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6df92cb4-5fc9-4e32-961a-a4ff5ca24560/documents/IUC5-e471bbfc-2cba-4605-b284-8e0147313c87_97b9d641-d717-498d-a195-ac00cd3f3e75.html,,,,,, "1,3-diphenyl-2-thiourea",102-08-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6df92cb4-5fc9-4e32-961a-a4ff5ca24560/documents/IUC5-e471bbfc-2cba-4605-b284-8e0147313c87_97b9d641-d717-498d-a195-ac00cd3f3e75.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,3-diphenyl-2-thiourea",102-08-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6df92cb4-5fc9-4e32-961a-a4ff5ca24560/documents/IUC5-e471bbfc-2cba-4605-b284-8e0147313c87_97b9d641-d717-498d-a195-ac00cd3f3e75.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,3-diphenylpropane-1,3-dione",120-46-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable because all data come from GLP testing. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): reliable because all data come from GLP testing. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dccdf127-cc83-48ba-8383-ff17c92b8e8b/documents/IUC5-788e8f81-585b-4f82-b269-4f7165e9e563_3d28ec68-a5b0-41a8-af9c-5c9695910329.html,,,,,, "1,3-diphenylpropane-1,3-dione",120-46-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dccdf127-cc83-48ba-8383-ff17c92b8e8b/documents/IUC5-788e8f81-585b-4f82-b269-4f7165e9e563_3d28ec68-a5b0-41a8-af9c-5c9695910329.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3-diphenylpropane-1,3-dione",120-46-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dccdf127-cc83-48ba-8383-ff17c92b8e8b/documents/IUC5-788e8f81-585b-4f82-b269-4f7165e9e563_3d28ec68-a5b0-41a8-af9c-5c9695910329.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3-divinylimidazolidin-2-one",13811-50-2,NOAEL: 50 mg/kg bw/day ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69bab07f-8083-4c69-8385-ea1869e6da58/documents/IUC5-ae1f07f7-2a94-4d69-a3a3-2249cf554ce0_b10785eb-11ef-41ab-a170-ef4be4d6edf3.html,,,,,, "1,3-divinylimidazolidin-2-one",13811-50-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69bab07f-8083-4c69-8385-ea1869e6da58/documents/IUC5-ae1f07f7-2a94-4d69-a3a3-2249cf554ce0_b10785eb-11ef-41ab-a170-ef4be4d6edf3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "1,3-divinylimidazolidin-2-one",13811-50-2,"AOT: In the acute oral toxicity study the LD50 (rat) was determined to be 6,987 mg/kg bw.AIT: In the acute inhalation toxicity study the LC50 (rat) was determined to be > 5.3 mg/L. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69bab07f-8083-4c69-8385-ea1869e6da58/documents/IUC5-30f45ae1-6668-41e4-8795-cfd841022790_b10785eb-11ef-41ab-a170-ef4be4d6edf3.html,,,,,, "1,3-divinylimidazolidin-2-one",13811-50-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69bab07f-8083-4c69-8385-ea1869e6da58/documents/IUC5-30f45ae1-6668-41e4-8795-cfd841022790_b10785eb-11ef-41ab-a170-ef4be4d6edf3.html,,oral,LD50,"6,987 mg/kg bw",no adverse effect observed, "1,3-divinylimidazolidin-2-one",13811-50-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69bab07f-8083-4c69-8385-ea1869e6da58/documents/IUC5-30f45ae1-6668-41e4-8795-cfd841022790_b10785eb-11ef-41ab-a170-ef4be4d6edf3.html,,inhalation,discriminating conc.,5.3 mg/m3,no adverse effect observed, "1,3-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, diazotized, coupled with diazotized 2-amino-4,6-dinitrophenol, diazotized 4-amino-5-hydroxy-2,7-naphthalenedisulfonic acid, diazotized 4-amino-3-methylbenzenesulfonic acid, diazotized 4-nitrobenzenamine and resorcinol, sodium salts",72480-09-2, NOAEL sub-acute (rat): 70 mg/Kg bw ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a36e8218-926c-44e8-bcc0-0e31c4e2b9ca/documents/cf711c6d-3779-478f-b1d7-eefadeb8e26f_7ab2a21f-8af8-4756-bf78-6d75fefa6548.html,,,,,, "1,3-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, diazotized, coupled with diazotized 2-amino-4,6-dinitrophenol, diazotized 4-amino-5-hydroxy-2,7-naphthalenedisulfonic acid, diazotized 4-amino-3-methylbenzenesulfonic acid, diazotized 4-nitrobenzenamine and resorcinol, sodium salts",72480-09-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a36e8218-926c-44e8-bcc0-0e31c4e2b9ca/documents/cf711c6d-3779-478f-b1d7-eefadeb8e26f_7ab2a21f-8af8-4756-bf78-6d75fefa6548.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,70 mg/kg bw/day,,rat "1,3-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, diazotized, coupled with diazotized 2-amino-4,6-dinitrophenol, diazotized 4-amino-5-hydroxy-2,7-naphthalenedisulfonic acid, diazotized 4-amino-3-methylbenzenesulfonic acid, diazotized 4-nitrobenzenamine and resorcinol, sodium salts",72480-09-2," Acute oral toxicity, LD50: > 2000 mg/kg bw Acute inhalation toxicity: waiving Acute dermal toxicity: LD50 male/female: > 2000 mg/Kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a36e8218-926c-44e8-bcc0-0e31c4e2b9ca/documents/0b409dd0-7f07-4bf9-a37a-bab7b4d9c1bc_7ab2a21f-8af8-4756-bf78-6d75fefa6548.html,,,,,, "1,3-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, diazotized, coupled with diazotized 2-amino-4,6-dinitrophenol, diazotized 4-amino-5-hydroxy-2,7-naphthalenedisulfonic acid, diazotized 4-amino-3-methylbenzenesulfonic acid, diazotized 4-nitrobenzenamine and resorcinol, sodium salts",72480-09-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a36e8218-926c-44e8-bcc0-0e31c4e2b9ca/documents/0b409dd0-7f07-4bf9-a37a-bab7b4d9c1bc_7ab2a21f-8af8-4756-bf78-6d75fefa6548.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, diazotized, coupled with diazotized 2-amino-4,6-dinitrophenol, diazotized 4-amino-5-hydroxy-2,7-naphthalenedisulfonic acid, diazotized 4-amino-3-methylbenzenesulfonic acid, diazotized 4-nitrobenzenamine and resorcinol, sodium salts",72480-09-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a36e8218-926c-44e8-bcc0-0e31c4e2b9ca/documents/0b409dd0-7f07-4bf9-a37a-bab7b4d9c1bc_7ab2a21f-8af8-4756-bf78-6d75fefa6548.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3-phenylenebis((4-hydroxyphenyl)methanone)",5436-05-5," In an OECD 422 test guideline study, Wistar Han rats were treated with 1,3-Bis (4-hydroxy benzoyl) benzene by daily oral gavage at dose levels of 100, 300 and 1000 mg/kg/day. The rats of the control group received the vehicle, 1% aqueous carboxymethyl cellulose, alone. Males were treated for a total of 29 days. Females that delivered offspring were treated for a total of 50-63 days. Females that failed to deliver pups were treated for 43-54 days. The main finding in parental animals was a retinal atrophy of the eyes in 2/5 females at the highest dose level tested (1000 mg/kg/day), at minimal degree. Retinal atrophy is a finding which is occasionally observed in control rats, however, as the lesion was not present in the control group of the current study, a relation with treatment cannot be excluded. Since the eye can be seen as part of the central nervous system with very limited to no regenerative capacity, this finding was considered adverse. There were no toxicologically significant changes in any reproductive parameters examined. In the offspring, developmental toxicity was observed at the highest dose level tested (1000 mg/kg/day). Body weights of female and male pups were decreased from PND 4. As no recovery in body weights was or could be observed beyong this time point, these decreases were considered adverse. A shift towards more males than females was observed at 1000 mg/kg/day and was considered non adverse in absence of effects on anogenital distance, thyroid hormone levels and nipple retention. As the shift towards more males than females was present in most litters (7 out of 8 litters), a test item related effect could not be excluded. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9332e3df-6faa-4996-8c9e-e4771936cbcc/documents/3f306899-92f3-451d-8921-9f6585777f3c_6dbbb13a-4922-472a-a9dc-9848801f814e.html,,,,,, "1,3-phenylenebis((4-hydroxyphenyl)methanone)",5436-05-5,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9332e3df-6faa-4996-8c9e-e4771936cbcc/documents/3f306899-92f3-451d-8921-9f6585777f3c_6dbbb13a-4922-472a-a9dc-9848801f814e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "1,3-phenylenebis((4-hydroxyphenyl)methanone)",5436-05-5," - Acute oral toxicity: LD50 (female) > 2000 mg/kg bw (OECD 423, GLP, K, Rel. 1) ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9332e3df-6faa-4996-8c9e-e4771936cbcc/documents/f29d9dc0-3b55-467f-80fb-2db7a3973279_6dbbb13a-4922-472a-a9dc-9848801f814e.html,,,,,, "1,3-phenylenebis((4-hydroxyphenyl)methanone)",5436-05-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9332e3df-6faa-4996-8c9e-e4771936cbcc/documents/f29d9dc0-3b55-467f-80fb-2db7a3973279_6dbbb13a-4922-472a-a9dc-9848801f814e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3-bis[2-(hexadecanoyloxy)ethoxy]benzene",1255203-42-9,Oral LD50 (rat): > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39089bf1-c59c-45eb-b3b5-327eff764b4f/documents/IUC5-fb4991d6-67f0-45c7-b4e2-47b90f38a62e_8e71719e-a313-49be-9002-04c7b4da9fdc.html,,,,,, "1,3-bis[2-(hexadecanoyloxy)ethoxy]benzene",1255203-42-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39089bf1-c59c-45eb-b3b5-327eff764b4f/documents/IUC5-fb4991d6-67f0-45c7-b4e2-47b90f38a62e_8e71719e-a313-49be-9002-04c7b4da9fdc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N-(2-(dimethylamino)ethoxy)ethyl)-N-methyl-1,3-propanediamine",189253-72-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80b9155d-9cfd-4aaf-9367-82d55fa2e18a/documents/7f4ecbe8-ab49-4f23-93bd-89a5b026f93b_3553e92c-b073-4fc9-98a2-55cdd460ebed.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "N-(2-(dimethylamino)ethoxy)ethyl)-N-methyl-1,3-propanediamine",189253-72-3,The acute oral LD50 is 1000 mg/kg in rats. Substance is corrosive to skin and eyes so further acute testing was not performed. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80b9155d-9cfd-4aaf-9367-82d55fa2e18a/documents/99a61f36-2794-4a39-b4c4-52f9b8ca9f39_3553e92c-b073-4fc9-98a2-55cdd460ebed.html,,,,,, "N-(2-(dimethylamino)ethoxy)ethyl)-N-methyl-1,3-propanediamine",189253-72-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80b9155d-9cfd-4aaf-9367-82d55fa2e18a/documents/99a61f36-2794-4a39-b4c4-52f9b8ca9f39_3553e92c-b073-4fc9-98a2-55cdd460ebed.html,,oral,LD50,"1,000 mg/kg bw",, "Methacryloamidopropyl-pentamethyl-1,3-propylene-2-ol-ammonium dichloride",86702-10-5, Oral LD50 in rat: > 2000 mg/kg bw (OECD 423 and GLPs compliant study) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ecac7df-89da-4822-bb03-38fd46aec4fa/documents/666ecf77-8510-4e0b-acae-b38164f42c54_f5511037-71fe-47d7-b979-b25da4bd77bc.html,,,,,, "Methacryloamidopropyl-pentamethyl-1,3-propylene-2-ol-ammonium dichloride",86702-10-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ecac7df-89da-4822-bb03-38fd46aec4fa/documents/666ecf77-8510-4e0b-acae-b38164f42c54_f5511037-71fe-47d7-b979-b25da4bd77bc.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-hydroxy-N,N'-bis(2-hydroxyethyl)-N,N,N',N'-tetramethylpropane-1,3-diaminium dichloride",110528-94-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d218c5c-f4d2-4a73-94f4-4e7cd955b3df/documents/IUC5-a5a82612-5ed5-4ea7-b084-461d4e653438_879c2b9b-6ed5-41dc-a470-0fb3f4280fb2.html,,oral,discriminating dose,"1,400 mg/kg bw",no adverse effect observed, "1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether",91648-24-7,"An OECD 422 screening study 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether is available. A NOAEL of 750 mg/kg bw/d is concluded for this study in the absence of any toxicologically relevant or adverse findings.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A GLP and guideline-compliant OECD 422 study is available for 1,3-propanediol, 2,2- bis(hydroxymethyl) -, allyl ether ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4026fd5a-364c-4658-8227-60d04a027d14/documents/4d21f50c-15e5-4e39-8f2d-82a686e6abec_c1320c5d-8f3c-4bd1-a3c8-fe411ea873a2.html,,,,,, "1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether",91648-24-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4026fd5a-364c-4658-8227-60d04a027d14/documents/4d21f50c-15e5-4e39-8f2d-82a686e6abec_c1320c5d-8f3c-4bd1-a3c8-fe411ea873a2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether",91648-24-7," An acute oral toxicity study in rats is available. No deaths were recorded for the duration of the study. Clinical signs included signs of prostration and a decreased respiratory rate, pallor of the extremities and abdominal distention in a male. No gross abnormalities were noted for any of the animals when necropsied at the conclusion of the study. The LD50 value for male and female animals was greater than 5000 mg/kg/bw.  ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4026fd5a-364c-4658-8227-60d04a027d14/documents/ce0e6fb6-9ccf-45d6-b387-251d9356d022_c1320c5d-8f3c-4bd1-a3c8-fe411ea873a2.html,,,,,, "1,3-Propanediol, 2,2-bis(hydroxymethyl)-, allyl ether",91648-24-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4026fd5a-364c-4658-8227-60d04a027d14/documents/ce0e6fb6-9ccf-45d6-b387-251d9356d022_c1320c5d-8f3c-4bd1-a3c8-fe411ea873a2.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, [[2-[2-[2-(3-chloro-2-hydroxy-propoxy)propoxymethyl]-3-(2-prop-2-enoyloxypropoxy)-2-(2-prop-2-enoyloxypropoxymethyl)propoxy]-1-methyl-ethyl] prop-2-enoate,57903-73-8,"Read across studiesPETIA: rat, oral: NOAEL systemic = 75mg/kg (OECD 422, GLP, 2010) ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/da0336b6-6539-4083-9296-b2d8117d31c4/documents/IUC5-878b6bb7-08c9-40ef-8be3-6aa6f8c6db2e_22ac5ac7-21ed-4113-9b91-9cef16b1f97e.html,,,,,, [[2-[2-[2-(3-chloro-2-hydroxy-propoxy)propoxymethyl]-3-(2-prop-2-enoyloxypropoxy)-2-(2-prop-2-enoyloxypropoxymethyl)propoxy]-1-methyl-ethyl] prop-2-enoate,57903-73-8,"LD50 p.o. rat: > 2000 mg/kg bw (BASF SE, 2013)LD50 dermal: > 2000 mg/kg bw (BASF SE, 2013) ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da0336b6-6539-4083-9296-b2d8117d31c4/documents/IUC5-736af593-05ad-45bc-bb09-291175648e81_22ac5ac7-21ed-4113-9b91-9cef16b1f97e.html,,,,,, [[2-[2-[2-(3-chloro-2-hydroxy-propoxy)propoxymethyl]-3-(2-prop-2-enoyloxypropoxy)-2-(2-prop-2-enoyloxypropoxymethyl)propoxy]-1-methyl-ethyl] prop-2-enoate,57903-73-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da0336b6-6539-4083-9296-b2d8117d31c4/documents/IUC5-736af593-05ad-45bc-bb09-291175648e81_22ac5ac7-21ed-4113-9b91-9cef16b1f97e.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, [[2-[2-[2-(3-chloro-2-hydroxy-propoxy)propoxymethyl]-3-(2-prop-2-enoyloxypropoxy)-2-(2-prop-2-enoyloxypropoxymethyl)propoxy]-1-methyl-ethyl] prop-2-enoate,57903-73-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da0336b6-6539-4083-9296-b2d8117d31c4/documents/IUC5-736af593-05ad-45bc-bb09-291175648e81_22ac5ac7-21ed-4113-9b91-9cef16b1f97e.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,4,4-trimethyl-2,3-diazabicyclo[3.2.2]non-2-ene 2,3-dioxide",34122-40-2, The oral LD50 for the test item was estimated to be 939.8 mg/kg for female rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecc4ebf8-72d0-4105-96d3-0c961aae12a0/documents/69c17981-cc55-4774-9757-d0bf00985366_4e5140a2-efe1-459f-8667-386bf9eebdc5.html,,,,,, "1,4,4-trimethyl-2,3-diazabicyclo[3.2.2]non-2-ene 2,3-dioxide",34122-40-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecc4ebf8-72d0-4105-96d3-0c961aae12a0/documents/69c17981-cc55-4774-9757-d0bf00985366_4e5140a2-efe1-459f-8667-386bf9eebdc5.html,,oral,LD50,939.8 mg/kg bw,adverse effect observed, "1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride",115-27-5, The following results were obtained for chlorendic anhydride: Oral NOAEL = 1242 mg/kg bw/day Dermal NOAEL = 2500 mg/kg bw day Inhalation NOAEC = 9970 mg/m³ The following results were obtained for chlorendic acid: Oral NOAEL (female) = 620 ppm in diet Oral NOAEL (male) = 1250 ppm in diet Inhalation NOAEC = 0.134 mg/L ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e429cc2-27c7-4670-b343-4b2114f2d747/documents/IUC5-655ee9f9-6ab9-41dd-bb20-465f61b31908_2a717204-d804-488e-9504-7f207d80b0d0.html,,,,,, "1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride",115-27-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e429cc2-27c7-4670-b343-4b2114f2d747/documents/IUC5-655ee9f9-6ab9-41dd-bb20-465f61b31908_2a717204-d804-488e-9504-7f207d80b0d0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,242 mg/kg bw/day",,rat "1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride",115-27-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e429cc2-27c7-4670-b343-4b2114f2d747/documents/IUC5-655ee9f9-6ab9-41dd-bb20-465f61b31908_2a717204-d804-488e-9504-7f207d80b0d0.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,500 mg/kg bw/day",,rabbit "1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride",115-27-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e429cc2-27c7-4670-b343-4b2114f2d747/documents/IUC5-655ee9f9-6ab9-41dd-bb20-465f61b31908_2a717204-d804-488e-9504-7f207d80b0d0.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"9,970 mg/m3",,rat "1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride",115-27-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e429cc2-27c7-4670-b343-4b2114f2d747/documents/IUC5-a891f9f9-9d39-4406-a446-08aedf694c30_2a717204-d804-488e-9504-7f207d80b0d0.html,,oral,LD50,"2,336 mg/kg bw",, "1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride",115-27-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e429cc2-27c7-4670-b343-4b2114f2d747/documents/IUC5-a891f9f9-9d39-4406-a446-08aedf694c30_2a717204-d804-488e-9504-7f207d80b0d0.html,,dermal,LD50,"10,000 mg/kg bw",, "1,4,5,6,7,7-hexachloro-8,9,10-trinorborn-5-ene-2,3-dicarboxylic anhydride",115-27-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e429cc2-27c7-4670-b343-4b2114f2d747/documents/IUC5-a891f9f9-9d39-4406-a446-08aedf694c30_2a717204-d804-488e-9504-7f207d80b0d0.html,,inhalation,LC50,"203,000 mg/m3",, "1,4,6,10-Dodecatetraen-3-ol,3,7,11-trimethyl-,(4E,6E)-",59121-99-2,"The acute oral toxicity in rats of the test item was determined in an OECD guideline study (BASF, 1999). The LD50 was determined to be > 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84f9b3bb-1260-4160-9e18-53c4f9d96866/documents/IUC5-7d42a023-89fc-4329-b45a-0d0fe8fa51bd_26376633-c0e1-4417-ba83-fa907ddeb792.html,,,,,, "1,4,6,10-Dodecatetraen-3-ol,3,7,11-trimethyl-,(4E,6E)-",59121-99-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84f9b3bb-1260-4160-9e18-53c4f9d96866/documents/IUC5-7d42a023-89fc-4329-b45a-0d0fe8fa51bd_26376633-c0e1-4417-ba83-fa907ddeb792.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,4,7,10-tetraazacyclododecane",294-90-6,"Subacute oral administration of Cyclen to rats according to OECD TG 422 (Barraclough, 2019) revealed a NOAEL of 30 mg/kg bw/day for systemic toxicity (target organ: stomach). The study is GLP compliant and is of high quality (Klimisch score=1) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/928ebafb-1c20-4b7c-9800-7f10f70a1351/documents/2a6325bd-f3db-4c8b-8ac5-51f80fd88df9_6b756f23-04cd-42e8-96d4-3e3ae685db93.html,,,,,, "1,4,7,10-tetraazacyclododecane",294-90-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/928ebafb-1c20-4b7c-9800-7f10f70a1351/documents/2a6325bd-f3db-4c8b-8ac5-51f80fd88df9_6b756f23-04cd-42e8-96d4-3e3ae685db93.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "1,4,7,10-tetraazacyclododecane",294-90-6,"The acute toxicity (LD50) of Cyclen in rats is > 200 - < 2000 mg/kg bw after oral administration (Meyer, 2003) or 935 mg/kg bw (for both sexes combined) after dermal administration (Pels Rijcken, 1996a). The study is GLP compliant and is of high quality (Klimisch score=1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/928ebafb-1c20-4b7c-9800-7f10f70a1351/documents/e91cf9ce-77da-4b67-a153-97cfe5fb3106_6b756f23-04cd-42e8-96d4-3e3ae685db93.html,,,,,, "1,4,7,10-tetraazacyclododecane",294-90-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/928ebafb-1c20-4b7c-9800-7f10f70a1351/documents/e91cf9ce-77da-4b67-a153-97cfe5fb3106_6b756f23-04cd-42e8-96d4-3e3ae685db93.html,,oral,discriminating dose,200 mg/kg bw,adverse effect observed, "1,4,7,10-tetraazacyclododecane",294-90-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/928ebafb-1c20-4b7c-9800-7f10f70a1351/documents/e91cf9ce-77da-4b67-a153-97cfe5fb3106_6b756f23-04cd-42e8-96d4-3e3ae685db93.html,,dermal,LD50,935 mg/kg bw,adverse effect observed, "(3R,3aR,6S,6aR)-hexahydrofuro[3,2-b]furan-3,6-diyl dioctanoate",64896-70-4,28-day toxicity in the rat by the oral route followed by a 14-day recovery period: NOAEL = 2000 mg/kg bw/d (with the analogous substance DEI)13-week oral toxicity study in the rat including recovery and TK: NOAEL = 2000 mg/kg bw/d (with the analogous substance DEI) ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/373ddd4a-e403-4658-9e48-40e0c101c51b/documents/IUC5-8a97d5cb-6c17-4973-a922-cd5708ee65aa_304311db-2138-4afa-be7d-91e3def433bb.html,,,,,, "(3R,3aR,6S,6aR)-hexahydrofuro[3,2-b]furan-3,6-diyl dioctanoate",64896-70-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/373ddd4a-e403-4658-9e48-40e0c101c51b/documents/IUC5-8a97d5cb-6c17-4973-a922-cd5708ee65aa_304311db-2138-4afa-be7d-91e3def433bb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,000 mg/kg bw/day",,rat "(3R,3aR,6S,6aR)-hexahydrofuro[3,2-b]furan-3,6-diyl dioctanoate",64896-70-4,The oral LD50 of DOI is > 2000 mg/kg bw (with no mortality at this dose level). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/373ddd4a-e403-4658-9e48-40e0c101c51b/documents/IUC5-bdff08bc-0491-45cb-b5d0-3ceeecf62617_304311db-2138-4afa-be7d-91e3def433bb.html,,,,,, "1,4-Androstadiene-3,17-dione, 2-Naphthol-Complex",103799-56-0,"LD50 oral (rat): > 2000 mg/kg bw (Kurth, 1996a)LD50 dermal (rat): > 2000 mg/kg bw (Kurth, 1996b) ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4df263b6-8311-406a-bcec-693a5cde90af/documents/IUC5-da1ee8ce-c6dd-4107-8af1-c18762a79895_8aef413d-f570-4c4a-b5a0-da08f084ad33.html,,,,,, "1,4-Androstadiene-3,17-dione, 2-Naphthol-Complex",103799-56-0,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4df263b6-8311-406a-bcec-693a5cde90af/documents/IUC5-da1ee8ce-c6dd-4107-8af1-c18762a79895_8aef413d-f570-4c4a-b5a0-da08f084ad33.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,4-Androstadiene-3,17-dione, 2-Naphthol-Complex",103799-56-0,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4df263b6-8311-406a-bcec-693a5cde90af/documents/IUC5-da1ee8ce-c6dd-4107-8af1-c18762a79895_8aef413d-f570-4c4a-b5a0-da08f084ad33.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.",68953-84-4,"1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs. induces changes in organ weights, blood serum and haematologic parameters upon repeated oral exposure of rats. Some evidence of macrocytic anemia was demonstrated. Evaluation of the test results leads to a NOAEL of 16.00 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75e4c00c-a8cd-4e60-8f09-2bb2bc900208/documents/7357ca97-a471-4375-a301-d6b106fa7bbc_d44bc106-6a3c-4ef3-9a41-eff1561a8999.html,,,,,, "1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.",68953-84-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75e4c00c-a8cd-4e60-8f09-2bb2bc900208/documents/7357ca97-a471-4375-a301-d6b106fa7bbc_d44bc106-6a3c-4ef3-9a41-eff1561a8999.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,16 mg/kg bw/day,, "1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.",68953-84-4,"The multi-constituent substance 1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs. is almost non-toxic via oral and dermal routes in test animals. The oral LD50 in rats is >5000 mg/kg bw, the dermal LD50 in rabbits is >2000 mg/kg bw. No test data regarding inhalatory exposure are available. Testing of acute toxicity via inhalation is inappropriate since exposure via this route is not likely due to low vapour pressure and low dustiness of the test substance. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75e4c00c-a8cd-4e60-8f09-2bb2bc900208/documents/9c3c0f62-180e-44eb-be95-c2bc5a393402_d44bc106-6a3c-4ef3-9a41-eff1561a8999.html,,,,,, "1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.",68953-84-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75e4c00c-a8cd-4e60-8f09-2bb2bc900208/documents/9c3c0f62-180e-44eb-be95-c2bc5a393402_d44bc106-6a3c-4ef3-9a41-eff1561a8999.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,4-Benzenediamine, N,N'-mixed Ph and tolyl derivs.",68953-84-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75e4c00c-a8cd-4e60-8f09-2bb2bc900208/documents/9c3c0f62-180e-44eb-be95-c2bc5a393402_d44bc106-6a3c-4ef3-9a41-eff1561a8999.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,4-Benzenedicarboxylic acid, compd. with 1,6-hexanediamine (1:1)",3160-86-9,LD50 oral > 2000 mg/kg. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ab17493-b9b7-4b60-a02a-64b05aeb4c7f/documents/IUC5-f1e3d8ce-1f33-4931-b1c9-07dca70b7a65_2f147b0c-5738-4688-9b98-24f37a3247f3.html,,,,,, "1,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from",68988-22-7,"Based on provisions in Annex XI (Substance-tailored exposure-driven testing) 3.2. (b) no tests for repeated dose toxicity are required (See 3.1.: ""Testing in accordance with Sections 8.6 and 8.7 of Annex VIII and in accordance with Annex IX and Annex X may be omitted based on the exposure scenario(s) developed in the Chemical Safety Report""). ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f208ba2a-e6dc-423b-9797-7ea3587f8e1b/documents/IUC5-5d4b495b-9e73-4e3c-9c2c-af36f8be5a8d_bb97bd5c-2fb6-4849-9774-0f5f06b1a4aa.html,,,,,, "1,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from",68988-22-7,LD50(oral): >2000 mg/kg body weightLD50(dermal): >2000 mg/kg body weight ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f208ba2a-e6dc-423b-9797-7ea3587f8e1b/documents/IUC5-8546b57a-b132-4af2-ab1f-235b0f56cfa5_bb97bd5c-2fb6-4849-9774-0f5f06b1a4aa.html,,,,,, "1,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from",68988-22-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f208ba2a-e6dc-423b-9797-7ea3587f8e1b/documents/IUC5-8546b57a-b132-4af2-ab1f-235b0f56cfa5_bb97bd5c-2fb6-4849-9774-0f5f06b1a4aa.html,,oral,discriminating dose,"2,000 mg/kg bw",, "1,4-Benzenedicarboxylic acid, dimethyl ester, manuf. of, by-products from",68988-22-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f208ba2a-e6dc-423b-9797-7ea3587f8e1b/documents/IUC5-8546b57a-b132-4af2-ab1f-235b0f56cfa5_bb97bd5c-2fb6-4849-9774-0f5f06b1a4aa.html,,dermal,discriminating dose,"2,000 mg/kg bw",, "1,4-bis(2,3-epoxypropoxy)butane",2425-79-8,"A 28-day, GLP, repeated dose oral toxicity study in rats conducted according to OECD test guideline 407 demonstrated a NOAEL of 200 mg/kg body weight/day for systemic toxicity of 1,4-butanediol diglycidylether. The same results were found in an OECD 422 study performed with 1,6-hexane diglycidylether. A sub-chronic OECD 408 study performed with 1,6-hexane diglycidylether has shown a NOAEL for systemic toxicity to be 300 mg/kg bw/d and this result can be used for read-across to the structural analogue 1,4-butanediol diglycidylether. Considering the slightly lower molecular weight of the 1,4-butanediol derivative, the NOAEL can be converted to 263 mg/kg bw/d on an equimolar basis. Thus, it can be assumed that 1,4-butanediol diglycidylether is of low systemic toxicity in repeated-dose studies via oral application. Nevertheless, following a conservative approach, the results from the sub-acute oral toxicity study on 1,4-butanediol diglycidylether are used for DNEL derivation and risk assessment. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c45a73b8-e626-45d2-8351-4b2c869bf886/documents/7b3dccd7-f352-42c6-ab6a-f19b1895b354_62c45ed7-36a2-4dbd-80d1-aa08699f5b60.html,,,,,, "1,4-bis(2,3-epoxypropoxy)butane",2425-79-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c45a73b8-e626-45d2-8351-4b2c869bf886/documents/7b3dccd7-f352-42c6-ab6a-f19b1895b354_62c45ed7-36a2-4dbd-80d1-aa08699f5b60.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "1,4-bis(2,3-epoxypropoxy)butane",2425-79-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c45a73b8-e626-45d2-8351-4b2c869bf886/documents/7b3dccd7-f352-42c6-ab6a-f19b1895b354_62c45ed7-36a2-4dbd-80d1-aa08699f5b60.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,263 mg/kg bw/day,,rat "1,4-bis(2,3-epoxypropoxy)butane",2425-79-8," Studies on butanediol diglycidyl ether have demonstrated that the compound is acutely toxic following oral exposure, particularly in rats. The oral LD50 of butanediol diglycidyl ether in rats was determined to be 1163 mg/kg body weight by Ullman et al. (1988) and 1410 mg/kg body weight by Kobel et al. (1983) in studies performed according to test guidelines and in compliance with good laboratory practice. Other studies support that the oral LD50 value is less than 2000 mg/kg body weight in rats. Clinical signs included sedation, dyspnea, hunched posture, ruffled fur, exophalmus, and lateral body position. In higher dose groups, coma, ataxia, latero-abdominal body position, and spasms were also observed in rats. In hamsters, the oral LD50 of butanediol diglycidyl ether was determined to be 3609 mg/kg body weight in a study performed according to test guidelines and in compliance with good laboratory practice. Butanediol diglycidyl ether is of low acute toxicity following dermal exposure. The dermal LD50 value for butanediol diglycidyl ether was reported to be greater than 2150 mg/kg body weight in rats in a study performed similar to test guidelines (Bathe, 1972). No rats died over the observation period, no signs of toxicity and no dermal reactions were observed, and no gross macroscopic changed were observed at necropsy. In accordance with column 2 of REACH (Regulation (EC) No 1907/2006) Annex VIII, the acute toxicity by inhalation study (required in section 8.5.2) does not need to be conducted as acute toxicity studies are available for the oral and dermal routes of exposure, and as inhalation exposure is rather unlikely. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c45a73b8-e626-45d2-8351-4b2c869bf886/documents/5f39dd2c-c1bc-4f13-b889-892bd69368e1_62c45ed7-36a2-4dbd-80d1-aa08699f5b60.html,,,,,, "1,4-bis(2,3-epoxypropoxy)butane",2425-79-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c45a73b8-e626-45d2-8351-4b2c869bf886/documents/5f39dd2c-c1bc-4f13-b889-892bd69368e1_62c45ed7-36a2-4dbd-80d1-aa08699f5b60.html,,oral,LD50,"1,163 mg/kg bw",adverse effect observed, "1,4-bis(mesitylamino)anthraquinone",116-75-6,"Oral administration to Wistar rats at doses of 100, 300 and 1000 mg/kg/day, for 28 days resulted in no substance related deaths, no clinical symptoms (at daily or weekly observations), no clinical symptoms (at the functional observational battery), no effects on food consumption or body weight development, no effects upon hematology and clinical biochemistry parameters, no changes in mean absolute or relative organ weights, and no macroscopical or microscopical findings of toxicological relevance. Based on the results of this study, 1000 mg/kg body weight/day was established as the no-observed-adverse-effect-level (NOAEL) for the test substance. Repeated dermal toxicity:The dermal route was waived. The substance is considered not to exert adverse effects.Repeated inhalation toxicity:The inhalation route was waived. The substance is considered not to exert adverse effects. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fef850b3-c5d6-4b13-bbb2-07dc808bcd9c/documents/IUC5-a6cdaf58-81c2-42d0-802a-c3fec25c07d9_16bea8d5-56f6-4095-85fe-631fbc76dc69.html,,,,,, "1,4-bis(mesitylamino)anthraquinone",116-75-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fef850b3-c5d6-4b13-bbb2-07dc808bcd9c/documents/IUC5-a6cdaf58-81c2-42d0-802a-c3fec25c07d9_16bea8d5-56f6-4095-85fe-631fbc76dc69.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,4-bis(mesitylamino)anthraquinone",116-75-6,"Acute oral toxicity: The test item did not cause any mortality, signs of intoxication, or necropsy findings after single oral gavage administration to male and female rats at 5000 mg/kg bw in a GLP compliant guideline study. Thus the LD50 value of the test item was found to be greater than 5000 mg/kg bw.Acute dermal toxicity: The test item did not cause any mortality, signs of intoxication, or necropsy findings after single dermal administration to male and female rats at 2000 mg/kg bw in a GLP compliant guideline study. Thus the LD50 value of the test item was found to be greater than 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fef850b3-c5d6-4b13-bbb2-07dc808bcd9c/documents/IUC5-d7bb9005-bf83-4589-95b5-c66dcb80fe13_16bea8d5-56f6-4095-85fe-631fbc76dc69.html,,,,,, "1,4-bis(mesitylamino)anthraquinone",116-75-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fef850b3-c5d6-4b13-bbb2-07dc808bcd9c/documents/IUC5-d7bb9005-bf83-4589-95b5-c66dcb80fe13_16bea8d5-56f6-4095-85fe-631fbc76dc69.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "1,4-bis(mesitylamino)anthraquinone",116-75-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fef850b3-c5d6-4b13-bbb2-07dc808bcd9c/documents/IUC5-d7bb9005-bf83-4589-95b5-c66dcb80fe13_16bea8d5-56f6-4095-85fe-631fbc76dc69.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,4-bis(methoxymethyl)benzene",6770-38-3," A Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test was performed for test substance in compliance with OECD TG422. Regarding the repeated-dose toxicity in males, the No-Observed-Adverse-Effect Level (NOAEL) and No-Observed-Effect Level (NOEL) was 50 mg/kg/day since bilateral focal atrophy of seminiferous tubules of the testis, bilateral germ cell debris in lumen of the epididymis and decreases in absolute and relative weights of the complex of the prostate and seminal grand were observed in males in the 200 mg/kg group. In females, the NOAEL was 200 mg/kg/day since centrilobular hypertrophy of hepatocytes, prominent nucleoli of hepatocytes and single cell necrosis of hepatocytes were observed in females in the 800 mg/kg group, and the NOEL was 50 mg/kg/day since increased levels of triglyceride and phospholipid were observed in females in the 200 mg/kg group. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6144f467-7d5a-438d-b0d7-75830bff0c34/documents/d46f2556-456b-4b79-88bf-454a2d919454_68020347-d974-4935-8c88-3c3e07ae26d5.html,,,,,, "1,4-bis(methoxymethyl)benzene",6770-38-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6144f467-7d5a-438d-b0d7-75830bff0c34/documents/d46f2556-456b-4b79-88bf-454a2d919454_68020347-d974-4935-8c88-3c3e07ae26d5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "1,4-bis(methoxymethyl)benzene",6770-38-3,"Oral: The oral LD50 value of test item in Female Crl:CD(SD) rats was established to be >2000 mg/kg body weight. Dermal: The acute dermal LD50 in rats for the test item was estimated to be more than 2000 mg/kg b.w. in female SD rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): 1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6144f467-7d5a-438d-b0d7-75830bff0c34/documents/e19267f8-2658-454e-890e-cc615051660b_68020347-d974-4935-8c88-3c3e07ae26d5.html,,,,,, "1,4-bis(methoxymethyl)benzene",6770-38-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6144f467-7d5a-438d-b0d7-75830bff0c34/documents/e19267f8-2658-454e-890e-cc615051660b_68020347-d974-4935-8c88-3c3e07ae26d5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,4-bis(methoxymethyl)benzene",6770-38-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6144f467-7d5a-438d-b0d7-75830bff0c34/documents/e19267f8-2658-454e-890e-cc615051660b_68020347-d974-4935-8c88-3c3e07ae26d5.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1,4-bis(vinyloxy)butane",3891-33-6,Acute oral toxicity: LD50 > 2000 mg/kg bwAcute inhalation toxicity: LD50 > 6.3 mg/L (maximum attainable vapour concentration) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5db05ac5-68bd-4195-83fd-72ccec654d5c/documents/IUC5-3a3ff19b-01be-4f6e-a952-9d0cc31ced4a_c8470a24-46ff-4f37-9172-fe43921cc24b.html,,,,,, "1,4-bis(vinyloxy)butane",3891-33-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5db05ac5-68bd-4195-83fd-72ccec654d5c/documents/IUC5-3a3ff19b-01be-4f6e-a952-9d0cc31ced4a_c8470a24-46ff-4f37-9172-fe43921cc24b.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,4-bis(vinyloxy)butane",3891-33-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5db05ac5-68bd-4195-83fd-72ccec654d5c/documents/IUC5-3a3ff19b-01be-4f6e-a952-9d0cc31ced4a_c8470a24-46ff-4f37-9172-fe43921cc24b.html,,inhalation,discriminating conc.,6.3 mg/m3,no adverse effect observed, "1,4-bis[(2,3-epoxypropoxy)methyl]cyclohexane",14228-73-0,"This was GLP study based on the OECD 422 guideline (Reproduction/Developmental toxicity screening Test).The purpose of this study was to evaluate the potential effects of 1,4-CHDM DGE, on general toxicity, neurological and reproductive function, andprenatal/early neonatal growth and survival of the offspring, following repeated gavage administration. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4625ef1f-c339-41c2-84b5-c98c29e3f9a9/documents/IUC5-54fc51d1-b706-4580-885e-6feb2958fedf_1b370eda-4e7b-4d61-8094-69a51f80a497.html,,,,,, "1,4-bis[(2,3-epoxypropoxy)methyl]cyclohexane",14228-73-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4625ef1f-c339-41c2-84b5-c98c29e3f9a9/documents/IUC5-54fc51d1-b706-4580-885e-6feb2958fedf_1b370eda-4e7b-4d61-8094-69a51f80a497.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "1,4-bis[(2,3-epoxypropoxy)methyl]cyclohexane",14228-73-0," Two current guideline, reliability 1 studies for acute oral toxicity and inhlation toxicity of CHDM DGE. The available oral and dermal LD50 values and the inhalation LC50 values are all above the classification cut-offs. In the rat, an inhalation 4-hour LC50 value of 12000 ppm and oral LD50 values of 5400 to 7200 mg/kg bw are reported. For the dermal route there are no human data and little animal data; in rabbits the dermal LD50 exceeds 2000 mg/kg bw.The main toxic effect associated with acute inhalation exposure (humans and animals) is CNS depression.Based on the available data, at a concentration of 30 ppm (161 mg/m3) for 15 minutes no adverse health effects are to be expected in humans. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4625ef1f-c339-41c2-84b5-c98c29e3f9a9/documents/IUC5-c1c92c9e-c2c7-4496-b3e3-1d93144ae08c_1b370eda-4e7b-4d61-8094-69a51f80a497.html,,,,,, "1,4-bis[(2,3-epoxypropoxy)methyl]cyclohexane",14228-73-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4625ef1f-c339-41c2-84b5-c98c29e3f9a9/documents/IUC5-c1c92c9e-c2c7-4496-b3e3-1d93144ae08c_1b370eda-4e7b-4d61-8094-69a51f80a497.html,,oral,LD50,"1,098 mg/kg bw",adverse effect observed, "1,4-bis[(2,6-diethyl-4-methylphenyl)amino]anthraquinone",32724-62-2,"Repeated dose toxicity: oral route: No study is available on Reinblau BLW.    Key information on Category members: - Reinblau RLW: short-term NOAEL (rats / combined) = 1000 mg/kg bw/day (OECD 407, GLP, K, rel.2) - Solvent Green 28: short-term NOAEL (rats / combined) = 1000 mg/kg bw/day (OECD 422, GLP, K, rel.1) - Solvent Violet 36: short-term NOAEL (rats / combined) = 1000 mg/kg bw/day (OECD 422, GLP, K, rel.1) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/199feb49-b2df-40a7-9de7-4994ab89cfa7/documents/IUC5-db1abd6c-f3a6-4b49-b6b6-6a4cd8f17ce8_668d450c-370a-4649-aff1-d107d74ab125.html,,,,,, "1,4-bis[(2,6-diethyl-4-methylphenyl)amino]anthraquinone",32724-62-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/199feb49-b2df-40a7-9de7-4994ab89cfa7/documents/IUC5-db1abd6c-f3a6-4b49-b6b6-6a4cd8f17ce8_668d450c-370a-4649-aff1-d107d74ab125.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,4-bis[(2,6-diethyl-4-methylphenyl)amino]anthraquinone",32724-62-2,"Acute oral toxicity: LD50 15000 mg/kg bw (OECD 401, K, rel.2).   Key information on Category members: - Reinblau RLW: Acute dermal toxicity: LD50 > 2000 mg/kg bw (discriminating dose) (OECD 402, K, rel.1)   There are no studies available for acute inhalation toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/199feb49-b2df-40a7-9de7-4994ab89cfa7/documents/IUC5-bc41b24b-605d-4e43-a417-a86c3ff60772_668d450c-370a-4649-aff1-d107d74ab125.html,,,,,, "1,4-bis[(2,6-diethyl-4-methylphenyl)amino]anthraquinone",32724-62-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/199feb49-b2df-40a7-9de7-4994ab89cfa7/documents/IUC5-bc41b24b-605d-4e43-a417-a86c3ff60772_668d450c-370a-4649-aff1-d107d74ab125.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "1,4-bis[(2,6-diethyl-4-methylphenyl)amino]anthraquinone",32724-62-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/199feb49-b2df-40a7-9de7-4994ab89cfa7/documents/IUC5-bc41b24b-605d-4e43-a417-a86c3ff60772_668d450c-370a-4649-aff1-d107d74ab125.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,4-bis[(2-ethyl-6-methylphenyl)amino]anthraquinone",41611-76-1,"Repeated dose toxicity: oral route: Short-term NOAEL (rats / combined) = 1000 mg/kg bw/day (OECD 407, GLP, K, rel.2)   Key information on Category members: - Solvent Green 28: short-term NOAEL (rats / combined) = 1000 mg/kg bw/day (OECD 422, GLP, K, rel.1) - Solvent Violet 36: short-term NOAEL (rats / combined) = 1000 mg/kg bw/day (OECD 422, GLP, K, rel.1) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/564e8aa7-f847-49d9-ad9c-1adddebd9e11/documents/IUC5-f9b3e05f-363e-45c9-bd56-2fe618c861f2_3b8bc300-85c6-4ff0-999a-750ed4addb18.html,,,,,, "1,4-bis[(2-ethyl-6-methylphenyl)amino]anthraquinone",41611-76-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/564e8aa7-f847-49d9-ad9c-1adddebd9e11/documents/IUC5-f9b3e05f-363e-45c9-bd56-2fe618c861f2_3b8bc300-85c6-4ff0-999a-750ed4addb18.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,4-bis[(2-ethyl-6-methylphenyl)amino]anthraquinone",41611-76-1,"- Acute oral toxicity: LD50 > 5000 mg/kg bw (discriminating dose) (OECD 401, K, rel.1). - Acute dermal toxicity: LD50 > 2000 mg/kg bw (discriminating dose) (OECD 402, K, rel.1). There are no studies available for acute inhalation toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/564e8aa7-f847-49d9-ad9c-1adddebd9e11/documents/IUC5-9f63710b-a782-4e7f-b60e-1ef7d28f4d69_3b8bc300-85c6-4ff0-999a-750ed4addb18.html,,,,,, "1,4-bis[(2-ethyl-6-methylphenyl)amino]anthraquinone",41611-76-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/564e8aa7-f847-49d9-ad9c-1adddebd9e11/documents/IUC5-9f63710b-a782-4e7f-b60e-1ef7d28f4d69_3b8bc300-85c6-4ff0-999a-750ed4addb18.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "1,4-bis[(2-ethyl-6-methylphenyl)amino]anthraquinone",41611-76-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/564e8aa7-f847-49d9-ad9c-1adddebd9e11/documents/IUC5-9f63710b-a782-4e7f-b60e-1ef7d28f4d69_3b8bc300-85c6-4ff0-999a-750ed4addb18.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,4-bis[(2-methylphenyl)amino]anthraquinone",6737-68-4," Acute oral toxicity:  Acute oral toxicity dose (LD50) of 1,4-bis[(2-methylphenyl)amino]anthraquinone (CAS no: 6737-68-4) was predicted based on OECD QSAR toolbox 2953 mg/kg bw and different studies available on structurally similar read across substances sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate (CAS No: 4430-18-6) >2000 mg/kg bw and 1,4-Bis(p-tolylamino)anthraquinone (CAS no: 128-80-3) 3660 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 1,4-bis[(2-methylphenyl)amino]anthraquinone cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  1,4-bis[(2-methylphenyl)amino]anthraquinone (CAS no: 6737-68-4) has very low vapour pressure (3.02E-11 Pa at 25°C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for 1,4-bis[(2-methylphenyl)amino] anthraquinone (CAS no: 6737-68-4) was predicted based on OECD QSAR toolbox 5857 mg/kg bw and different studies available for the structurally similar read across substance sodium 4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]toluene-3-sulphonate (CAS No: 4430-18-6) >2000 mg/kg bw and 1-(2-hydroxyethylamino)-4-(methylamino) anthracene-9,10-dione (CAS no: 2475-46-9) >2000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 1,4-bis[(2-methylphenyl)amino] anthraquinone cannot be classified for acute dermal toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2339a1ad-3add-4207-803c-282dc26ec9e1/documents/642e9424-8028-4753-a1ec-e9038b804923_1c44ecf8-6384-4b47-bbb9-c0e51b348dd2.html,,,,,, "1,4-bis[(2-methylphenyl)amino]anthraquinone",6737-68-4,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2339a1ad-3add-4207-803c-282dc26ec9e1/documents/642e9424-8028-4753-a1ec-e9038b804923_1c44ecf8-6384-4b47-bbb9-c0e51b348dd2.html,,oral,LD50,"2,953 mg/kg bw",no adverse effect observed, "1,4-bis[(2-methylphenyl)amino]anthraquinone",6737-68-4,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2339a1ad-3add-4207-803c-282dc26ec9e1/documents/642e9424-8028-4753-a1ec-e9038b804923_1c44ecf8-6384-4b47-bbb9-c0e51b348dd2.html,,dermal,LD50,"5,857 mg/kg bw",no adverse effect observed, "1,4-bis[(4-butylphenyl)amino]-5,8-dihydroxyanthraquinone",28198-05-2,"Acute toxicity: oral The acute toxicity study was predicted using OECD QSAR toolbox version 3.3 (2017); to evaluate the toxic effects of administration of 1,4-bis[(4-butylphenyl) amino]- 5,8-dihydroxyanthraquinone (CAS No.28198-05-2) in rat by the oral route. 50% mortality observed at 8935.82 mg/kg bw in treated rats. The acute oral median lethal dose (LD50) of 1,4-bis[(4-butylphenyl)amino]-5,8-dihydroxyanthraquinone in rat was estimated to be 8935.82 mg/kg b.wt.   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd1ad2fa-ecfd-4b4d-bd49-6195548667af/documents/3908b4a7-4960-4538-9c3a-e47f891a3325_a407a6e5-0b68-4eb4-ac08-7dc82261cea7.html,,,,,, "1,4-bis[(4-butylphenyl)amino]-5,8-dihydroxyanthraquinone",28198-05-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd1ad2fa-ecfd-4b4d-bd49-6195548667af/documents/3908b4a7-4960-4538-9c3a-e47f891a3325_a407a6e5-0b68-4eb4-ac08-7dc82261cea7.html,,oral,LD50,"8,935.82 mg/kg bw",no adverse effect observed, "1,4-bis[(vinyloxy)methyl]cyclohexane",17351-75-6,A  valid NOAEL of 200 mg/kg/day was established in a guideline conform 28 days oral toxiyity study with rats. Marked to moderate hairloss and a 10 % body weight loss were the most prominet effect observed in this study. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c03f863-3cc0-4da7-91d2-4086cae46b46/documents/IUC5-a2f720d0-a3a7-4e70-9790-a5bb0c7df110_e4158f0e-72a5-494d-b348-3d9bd7bf5bd8.html,,,,,, "1,4-bis[(vinyloxy)methyl]cyclohexane",17351-75-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c03f863-3cc0-4da7-91d2-4086cae46b46/documents/IUC5-a2f720d0-a3a7-4e70-9790-a5bb0c7df110_e4158f0e-72a5-494d-b348-3d9bd7bf5bd8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "1,4-bis[(vinyloxy)methyl]cyclohexane",17351-75-6,"Dimethanol-1,4-cyclohexane divinylether is of low toxicity after single ingestion and short term skin contact.LD50oral (rat): > 5000 mg/kgdermal (rabbit): > 2000 mg/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c03f863-3cc0-4da7-91d2-4086cae46b46/documents/IUC5-1421940e-097d-4474-b7fe-aa70c12cb9b6_e4158f0e-72a5-494d-b348-3d9bd7bf5bd8.html,,,,,, "1,4-bis[[4-(1,1-dimethylethyl)phenyl]amino]-5,8-dihydroxyanthraquinone",4851-50-7,"NOAEL = 1000 mg/kg bw/day (OECD 422, GLP, K, rel.1) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9eac061-d58e-40ea-8939-314f217ffe21/documents/4934cc7d-5bee-4456-a6eb-f0a99c431dfc_f043d423-9656-4e0a-8b7b-26207d30a4d6.html,,,,,, "1,4-bis[[4-(1,1-dimethylethyl)phenyl]amino]-5,8-dihydroxyanthraquinone",4851-50-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9eac061-d58e-40ea-8939-314f217ffe21/documents/4934cc7d-5bee-4456-a6eb-f0a99c431dfc_f043d423-9656-4e0a-8b7b-26207d30a4d6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,4-bis[[4-(1,1-dimethylethyl)phenyl]amino]-5,8-dihydroxyanthraquinone",4851-50-7,"Acute oral toxicity study: LD50 greater than 15000 mg/kg bw (discriminating dose) (Eqv. OECD 401, K, Rel.2).   Key information on Category members: - Reinblau RLW: Acute dermal toxicity: LD50 > 2000 mg/kg bw (discriminating dose) (OECD 402, K, rel.1)   There are no studies available for acute inhalation toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9eac061-d58e-40ea-8939-314f217ffe21/documents/6afc9fdd-0e3d-412b-b595-56b94d4a10e0_f043d423-9656-4e0a-8b7b-26207d30a4d6.html,,,,,, "1,4-bis[[4-(1,1-dimethylethyl)phenyl]amino]-5,8-dihydroxyanthraquinone",4851-50-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9eac061-d58e-40ea-8939-314f217ffe21/documents/6afc9fdd-0e3d-412b-b595-56b94d4a10e0_f043d423-9656-4e0a-8b7b-26207d30a4d6.html,,oral,discriminating dose,"15,000 mg/kg bw",no adverse effect observed, "1,4-bis[[4-(1,1-dimethylethyl)phenyl]amino]-5,8-dihydroxyanthraquinone",4851-50-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9eac061-d58e-40ea-8939-314f217ffe21/documents/6afc9fdd-0e3d-412b-b595-56b94d4a10e0_f043d423-9656-4e0a-8b7b-26207d30a4d6.html,,dermal,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, "1,4-Butanediyl 3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoate",1259300-69-0, NOAEL (male/female) ≥ 1000 mg/kg/ day ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f0663fb-9d7d-4eae-a433-3bf773b350cd/documents/14cad38b-343f-43c8-b037-b54c57c5307c_16c61560-22d3-4c00-9bf4-14bd21c0ca77.html,,,,,, "1,4-Butanediyl 3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoate",1259300-69-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f0663fb-9d7d-4eae-a433-3bf773b350cd/documents/14cad38b-343f-43c8-b037-b54c57c5307c_16c61560-22d3-4c00-9bf4-14bd21c0ca77.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,4-Butanediyl 3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoate",1259300-69-0, LD50 (oral) > 5000 mg/kg bw LD50 (dermal) > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f0663fb-9d7d-4eae-a433-3bf773b350cd/documents/c1cc6777-1dd8-473c-b22e-85f1220ad942_16c61560-22d3-4c00-9bf4-14bd21c0ca77.html,,,,,, "1,4-Butanediyl 3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoate",1259300-69-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f0663fb-9d7d-4eae-a433-3bf773b350cd/documents/c1cc6777-1dd8-473c-b22e-85f1220ad942_16c61560-22d3-4c00-9bf4-14bd21c0ca77.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "1,4-Butanediyl 3-(2,4-dimethyl-1,3-dioxolan-2-yl)propanoate",1259300-69-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f0663fb-9d7d-4eae-a433-3bf773b350cd/documents/c1cc6777-1dd8-473c-b22e-85f1220ad942_16c61560-22d3-4c00-9bf4-14bd21c0ca77.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,4-butanediyl diacrylate",1070-70-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e5da7d9-cfad-40b5-a343-203111fba69d/documents/ca22a1c9-699f-4288-a503-ec19cf09edb6_54cf019b-dcda-474a-a008-de4a71e5beba.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "1,4-butanediyl diacrylate",1070-70-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e5da7d9-cfad-40b5-a343-203111fba69d/documents/3f6ff70f-3cbb-4d3c-88e5-c886669c78c9_54cf019b-dcda-474a-a008-de4a71e5beba.html,,oral,LD50,"1,336 mg/kg bw",adverse effect observed, "1,4-butanediyl diacrylate",1070-70-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e5da7d9-cfad-40b5-a343-203111fba69d/documents/3f6ff70f-3cbb-4d3c-88e5-c886669c78c9_54cf019b-dcda-474a-a008-de4a71e5beba.html,,dermal,discriminating dose,400 mg/kg bw,adverse effect observed, "1,4-butanediyl diacrylate",1070-70-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e5da7d9-cfad-40b5-a343-203111fba69d/documents/3f6ff70f-3cbb-4d3c-88e5-c886669c78c9_54cf019b-dcda-474a-a008-de4a71e5beba.html,,inhalation,discriminating conc.,60 mg/m3,no adverse effect observed, "trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide",1215841-86-3,"A study was performed to evaluate the toxicity of trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide after a repeated administration per inhalation to rats, according to OECD-Guideline 412/413 as far as useful for a dose range finder study.The No-observed-effect-level (NOEL) of trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide dust was larger than 1.03 mg/L for rats after repeated exposure via inhalation for two weeks that represents the highest technically feasible concentration in the study.A 90 day oral repeated dose toxicity study was performed in rats according to OECD 408. Daily oral (gavage) administration of the test item to Wistar rats for 90 consecutive days at 100, 300 and 1000 mg/kg bw/day was associated with minor effects at the highest dose level only. In conclusion, the NOAEL of the test item administered by oral gavage to Wistar rats for 90 consecutive days is considered to be 300 mg/kg bw/day based on a precautionary worst case approach. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5dd17bbe-655e-43eb-b5fc-82f4e8ab2357/documents/IUC5-772bb6f4-7a9f-45ed-8784-934cf660a09e_241207e8-7494-417b-889e-bbed384a185c.html,,,,,, "trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide",1215841-86-3,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5dd17bbe-655e-43eb-b5fc-82f4e8ab2357/documents/IUC5-772bb6f4-7a9f-45ed-8784-934cf660a09e_241207e8-7494-417b-889e-bbed384a185c.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,030 mg/m3",,rat "trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide",1215841-86-3,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5dd17bbe-655e-43eb-b5fc-82f4e8ab2357/documents/IUC5-772bb6f4-7a9f-45ed-8784-934cf660a09e_241207e8-7494-417b-889e-bbed384a185c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide",1215841-86-3,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5dd17bbe-655e-43eb-b5fc-82f4e8ab2357/documents/IUC5-772bb6f4-7a9f-45ed-8784-934cf660a09e_241207e8-7494-417b-889e-bbed384a185c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,030 mg/m3",no adverse effect observed,rat "trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide",1215841-86-3," The acute toxicity of trans-N1,N1,N4,N4-Tetrakis(2-hydroxyethyl)1,4-cyclohexanedicarboxamide was examined. After oral application the LD50 for rats was found to be > 2000 mg/kg bw. The acute inhalation LC50 for rats was found to be > 5.07 mg/L . ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5dd17bbe-655e-43eb-b5fc-82f4e8ab2357/documents/IUC5-e3e73c88-8661-4856-88ca-adf7fe8f2105_241207e8-7494-417b-889e-bbed384a185c.html,,,,,, "1,4-Cyclohexanedicarboxylic acid, 1,4-bis[4-[6-[(1-oxo-2-propen-1-yl)oxy]hexyl]phenyl] ester, trans-",852056-62-3, GLP compliant OECD 423: LD50 (oral) > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63aefe4a-1641-4ded-990d-13324392aaaf/documents/924cad99-4107-43db-b082-8a001ddb4253_a88309ce-829a-40a4-b936-104fcaf5bc3e.html,,,,,, "1,4-Cyclohexanedicarboxylic acid, 1,4-bis[4-[6-[(1-oxo-2-propen-1-yl)oxy]hexyl]phenyl] ester, trans-",852056-62-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63aefe4a-1641-4ded-990d-13324392aaaf/documents/924cad99-4107-43db-b082-8a001ddb4253_a88309ce-829a-40a4-b936-104fcaf5bc3e.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,4-diamino-2,3-dichloroanthraquinone",81-42-5," Acute oral toxicity LD50 was estimated to be 875.122 mg/kg bw, when male Sprague-Dawley rats were exposed with 1,4-diamino-2,3-dichloroanthraquinone (81-42-5) orally. Acute dermal toxicity LD50 was estimated to be 9260.18mg/kg bw. When male and female New Zealand White rabbits were exposed with 1,4-diamino-2,3-dichloroanthraquinone (81-42-5) by dermal application. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc9e3c56-4e46-431e-b34b-be1873500063/documents/e2ff2ed1-f344-4733-a698-407b222ce86b_4fd4ede3-dde5-4983-b17d-6e953ba38765.html,,,,,, "1,4-diamino-2,3-dichloroanthraquinone",81-42-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc9e3c56-4e46-431e-b34b-be1873500063/documents/e2ff2ed1-f344-4733-a698-407b222ce86b_4fd4ede3-dde5-4983-b17d-6e953ba38765.html,,oral,LD50,875.122 mg/kg bw,adverse effect observed, "1,4-diamino-2,3-dichloroanthraquinone",81-42-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc9e3c56-4e46-431e-b34b-be1873500063/documents/e2ff2ed1-f344-4733-a698-407b222ce86b_4fd4ede3-dde5-4983-b17d-6e953ba38765.html,,dermal,LD50,"9,260.18 mg/kg bw",no adverse effect observed, "1,4-diamino-2,3-diphenoxyanthraquinone",6408-72-6," A valid Repeated Dose 28 Day Oral Toxicity Study in Rodents according to OECD TG 407 in the Han Wistar rat by oral gavage administration is available. The test item was administered by gavage to three groups, each of five male and five female rats, for twenty-eight consecutive days, at dose levels of 100, 300 or 1000 mg/kg bw/day.  A control group of five males and five females was dosed with vehicle alone (Arachis oil BP). The oral (gavage) administration of to rats, for twenty-eight days at dose levels of 100, 300 or 1000 mg/kg bw/day was well tolerated and did not result in any toxicologically significant effects. The ‘No Observed Adverse Effect Level’ (NOAEL) of Macrolex Rotviolet R for systemic toxicity was 1000 mg/kg bw/day (high dose) within the confines of this study type. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05ffdb52-b20f-4bda-9fb4-d632b08e94ed/documents/6a910ca3-25c4-43e1-bb8f-1ac64915c5dc_528f44a3-455f-4ed6-9a74-bcc2f8d6ad8b.html,,,,,, "1,4-diamino-2,3-diphenoxyanthraquinone",6408-72-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05ffdb52-b20f-4bda-9fb4-d632b08e94ed/documents/6a910ca3-25c4-43e1-bb8f-1ac64915c5dc_528f44a3-455f-4ed6-9a74-bcc2f8d6ad8b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,4-diamino-2,3-diphenoxyanthraquinone",6408-72-6," Several valid acute oral toxicity studies according or similar to OECD guideline 401 are available. The LD50 value in all studies was greater than 5000 mg/kg bw (discriminating dose). In a valid acute inhalation study according to OECD guideline 436 a LC50 greater than 5.04 mg/l (discriminating dose) was determined. No study for acute dermal toxicity is available: According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’. The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05ffdb52-b20f-4bda-9fb4-d632b08e94ed/documents/f9d672c5-5d8f-4a62-88dd-a26c52cfc8e9_528f44a3-455f-4ed6-9a74-bcc2f8d6ad8b.html,,,,,, "(1,4-diazabicyclo[2.2.2]octane-2-yl)methanol",76950-43-1," Oral (OECD 408), rat: NOAEL (local, males/females): 300 mg/kg bw/day Oral (OECD 408), rat: NOAEL (systemic, males/females) ≥ 1000 mg/kg bw/day The systemic NOAEL was considered relevant for the risk assessment. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6883cf9-0172-4700-8015-201fc78e5fbf/documents/IUC5-9d46b23f-6f4d-4e7e-83b2-3d3c88760613_69843ec6-3d04-4cec-b5d2-5a38ec112bb0.html,,,,,, "(1,4-diazabicyclo[2.2.2]octane-2-yl)methanol",76950-43-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6883cf9-0172-4700-8015-201fc78e5fbf/documents/IUC5-9d46b23f-6f4d-4e7e-83b2-3d3c88760613_69843ec6-3d04-4cec-b5d2-5a38ec112bb0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "(1,4-diazabicyclo[2.2.2]octane-2-yl)methanol",76950-43-1,"Oral (OECD 423), rat: LD50 > 2000 mg/kg bwDermal (OECD 402), rat: LD50 > 2000 mg/kg bw (limit test) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6883cf9-0172-4700-8015-201fc78e5fbf/documents/IUC5-f4c40c36-51f9-45d2-b9c0-50e182c554b6_69843ec6-3d04-4cec-b5d2-5a38ec112bb0.html,,,,,, "1,4-diazabicyclooctane",280-57-9,"Repeated exposure to 1,4-Diazabicyclo[2.2.2]octaneby inhalation at dose levels as high as 0.41 mg/L/6h/day caused localized toxicity at the site of contact, namely, the upper respiratory tract and the eyes of rats. No systemic toxicity was seen at 0.41 mg/L/6h/day. Repeated exposure to 1,4-Diazabicyclo[2.2.2]octaneby oral gavage at dose levels as high as 1000 mg/kg/day caused reversible inflammatory and proliferative effects in the kidneys and urinary bladder of rats. The NOAEL for systemic oral toxicity was 300 mg/kg/day for females and 100 mg/kg/day for males. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a82d26a-46cf-4112-9526-73f29a153830/documents/7f7ee4e3-307d-4a20-a866-15b09dcc1517_5325533e-27d5-4505-8b12-38fc12dc322d.html,,,,,, "1,4-diazabicyclooctane",280-57-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a82d26a-46cf-4112-9526-73f29a153830/documents/7f7ee4e3-307d-4a20-a866-15b09dcc1517_5325533e-27d5-4505-8b12-38fc12dc322d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1,4-diazabicyclooctane",280-57-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a82d26a-46cf-4112-9526-73f29a153830/documents/7f7ee4e3-307d-4a20-a866-15b09dcc1517_5325533e-27d5-4505-8b12-38fc12dc322d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,410 mg/m3,,rat "1,4-diazabicyclooctane",280-57-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a82d26a-46cf-4112-9526-73f29a153830/documents/7f7ee4e3-307d-4a20-a866-15b09dcc1517_5325533e-27d5-4505-8b12-38fc12dc322d.html,Repeated dose toxicity – local effects,inhalation,LOAEC,60 mg/m3,adverse effect observed,rat "1,4-diazabicyclooctane",280-57-9,"1,4-Diazabicyclo[2.2.2]octane is of low acute toxicity to animals following single oral, dermal or inhalation exposures. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a82d26a-46cf-4112-9526-73f29a153830/documents/10b002bc-9c56-44e7-bab9-99ae96b28936_5325533e-27d5-4505-8b12-38fc12dc322d.html,,,,,, "1,4-diazabicyclooctane",280-57-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a82d26a-46cf-4112-9526-73f29a153830/documents/10b002bc-9c56-44e7-bab9-99ae96b28936_5325533e-27d5-4505-8b12-38fc12dc322d.html,,oral,LD50,700 mg/kg bw,adverse effect observed, "1,4-diazabicyclooctane",280-57-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a82d26a-46cf-4112-9526-73f29a153830/documents/10b002bc-9c56-44e7-bab9-99ae96b28936_5325533e-27d5-4505-8b12-38fc12dc322d.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,4-dichloro-2-nitrobenzene",89-61-2," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on guinea pig for the test chemical 2, 5-Dichloronitrobenzene. The LD50 value is 800 mg/kg bw. The study concluded that the LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.005 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on study conducted on rats for the given test chemical 2, 5-Dichloronitrobenzene. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e657183-b751-447e-a320-e33aa6ba4fe9/documents/d7e08d2b-581c-4d2d-9dff-ee3e059ca88e_297199c2-82c6-479a-b1fa-b974167114a4.html,,,,,, "1,4-dichloro-2-nitrobenzene",89-61-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e657183-b751-447e-a320-e33aa6ba4fe9/documents/d7e08d2b-581c-4d2d-9dff-ee3e059ca88e_297199c2-82c6-479a-b1fa-b974167114a4.html,,oral,LD50,800 mg/kg bw,adverse effect observed, "1,4-dichloro-2-nitrobenzene",89-61-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e657183-b751-447e-a320-e33aa6ba4fe9/documents/d7e08d2b-581c-4d2d-9dff-ee3e059ca88e_297199c2-82c6-479a-b1fa-b974167114a4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,4-dichloro-5,8-dihydroxyanthraquinone",2832-30-6,A subchronic feeding study was performed on male and female Wistar rats. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcf1d44c-bef4-4d79-8f9e-9958d2d1f4d5/documents/f95c94be-9b0e-457d-8ffb-f92855c5605a_c7f370ac-3451-44f2-bc96-ad446e93150e.html,,,,,, "1,4-dichloro-5,8-dihydroxyanthraquinone",2832-30-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcf1d44c-bef4-4d79-8f9e-9958d2d1f4d5/documents/f95c94be-9b0e-457d-8ffb-f92855c5605a_c7f370ac-3451-44f2-bc96-ad446e93150e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,81.4 mg/kg bw/day,,rat "1,4-dichloro-5,8-dihydroxyanthraquinone",2832-30-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcf1d44c-bef4-4d79-8f9e-9958d2d1f4d5/documents/7043c56a-3a45-4c75-917d-176cb33f0966_c7f370ac-3451-44f2-bc96-ad446e93150e.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "1,4-diethylbenzene",105-05-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study is a GLP compliant and has Klimisch score 1. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3edc7b34-2357-4ec0-84e3-6fa6c5b263d1/documents/IUC5-aeb64e83-06b2-4ecc-aded-cbf164ff7223_4abb09f6-9540-4264-947c-b009ac815616.html,,,,,, "1,4-diethylbenzene",105-05-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3edc7b34-2357-4ec0-84e3-6fa6c5b263d1/documents/IUC5-aeb64e83-06b2-4ecc-aded-cbf164ff7223_4abb09f6-9540-4264-947c-b009ac815616.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "1,4-diethylbenzene",105-05-5,"The acute toxicity of 1,4-diethlybenzene has been determined in adequate studies in the rat following oral and inhalation administrations.1,4 -diethylbenzene is an hydrocarbon. Based on a dynamic viscosity of 3.6 mPa.s at 232K (4.1 mm2/s < 20 mm2/s) the substance can pose a hazard if swallowed and enter airways. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3edc7b34-2357-4ec0-84e3-6fa6c5b263d1/documents/IUC5-4de828f2-7645-4c11-9524-630f9eb31990_4abb09f6-9540-4264-947c-b009ac815616.html,,,,,, "1,4-diethylbenzene",105-05-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3edc7b34-2357-4ec0-84e3-6fa6c5b263d1/documents/IUC5-4de828f2-7645-4c11-9524-630f9eb31990_4abb09f6-9540-4264-947c-b009ac815616.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,4-diethylbenzene",105-05-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3edc7b34-2357-4ec0-84e3-6fa6c5b263d1/documents/IUC5-4de828f2-7645-4c11-9524-630f9eb31990_4abb09f6-9540-4264-947c-b009ac815616.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "1,4-dihydroxyanthraquinone",81-64-1,"LD50 (oral) > 5000 mg/kg bw (Loeser, 1979) LD50 (oral) > 5000 mg/kg bw (Loeser, 1976) LD50 (oral) > 5000 mg/kg bw (AMRL, 1979) LD50 (dermal) > 2500 mg/kg bw (Loeser, 1979) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73f5fc4d-9d6b-4810-9729-aefe8134a48b/documents/IUC5-e4d3205f-c1ad-4b6e-aaed-2bb7f0d8e15b_476f30b5-ed49-43db-b48d-1bfbdc74d7c7.html,,,,,, "1,4-dihydroxyanthraquinone",81-64-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73f5fc4d-9d6b-4810-9729-aefe8134a48b/documents/IUC5-e4d3205f-c1ad-4b6e-aaed-2bb7f0d8e15b_476f30b5-ed49-43db-b48d-1bfbdc74d7c7.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "1,4-dihydroxyanthraquinone",81-64-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73f5fc4d-9d6b-4810-9729-aefe8134a48b/documents/IUC5-e4d3205f-c1ad-4b6e-aaed-2bb7f0d8e15b_476f30b5-ed49-43db-b48d-1bfbdc74d7c7.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "1,4-diisopropylbenzene",100-18-5,Repeated dose toxicity oral In a study according to the OECD guideline 422 under GLP compliance the NOAEL for systemic toxicity was considered to be 1000 mg/kg/day.   Repeated dose toxicity inhalation No study available   Repeated dose toxicity dermal No study available ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f443b752-18d4-4f66-844a-e786cbccd27a/documents/561da47d-8104-4096-b9b0-a73527347c73_f43eb648-5fa5-449d-86c3-66aec20ada10.html,,,,,, "1,4-diisopropylbenzene",100-18-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f443b752-18d4-4f66-844a-e786cbccd27a/documents/561da47d-8104-4096-b9b0-a73527347c73_f43eb648-5fa5-449d-86c3-66aec20ada10.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,4-diisopropylbenzene",100-18-5,"Acute toxicity – oral/ rats Slightly toxic in oral route. LD50 > 3200 mg/kg body weight in male and female rats.   Acute toxicity – inhalation Not considered to be a relevant route of potential human exposure Acute toxicity – dermal Slightly toxic by the dermal route, LD50 > 20 mL/kg bw/d (= ca. 20000 mg/kg bw/d). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f443b752-18d4-4f66-844a-e786cbccd27a/documents/32095cc2-b8f9-4fd8-96a8-66fe69c2552f_f43eb648-5fa5-449d-86c3-66aec20ada10.html,,,,,, "1,4-diisopropylbenzene",100-18-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f443b752-18d4-4f66-844a-e786cbccd27a/documents/32095cc2-b8f9-4fd8-96a8-66fe69c2552f_f43eb648-5fa5-449d-86c3-66aec20ada10.html,,oral,LD50,"> 3,200 mg/kg bw",no adverse effect observed, "1,4-diisopropylbenzene",100-18-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f443b752-18d4-4f66-844a-e786cbccd27a/documents/32095cc2-b8f9-4fd8-96a8-66fe69c2552f_f43eb648-5fa5-449d-86c3-66aec20ada10.html,,dermal,LD50,"> 20,000 mg/kg bw",no adverse effect observed, "1,4-dimethoxy-2-nitrobenzene",89-39-4,"Acute oral toxicity according to OECD 401: LD50: 2120 mg/kg bwDose range finding study for Micronucleus test in mice: lethal oral dose: 1800 mg/kg bw, highest sublethal dose: 1300 mg/kg bwIn a repeated dose study (dietary administration) a substance with similar chemical structure (2-Nitroanisole) revealed methemoglobinemia at higer dose levels. (IARC MONOGRAPHS VOLUME 65) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cd79c88-a0f8-47f0-9b28-157511ae2cde/documents/IUC5-9f4e1884-297b-41f1-abe1-4d55c18c6b7b_2de2c9e6-eb2c-4d97-bd90-09afe57ce9bf.html,,,,,, "1,4-dimethyl-5-[[4-[methylbenzylamino]phenyl]azo]-1H-1,2,4-triazolium acetate",84000-82-8,"Repeated dose toxicity: Oral   Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for 1,4-dimethyl-5-[[4-[methylbenzylamino]phenyl]azo]-1H-1,2,4-triazolium acetate. The study assumed the use of male and female Wistar rats. Since no significant treatment related effects were observed, hence the No Observed Adverse Effect Level (NOAEL) for 1,4-dimethyl-5-[[4-[methylbenzylamino]phenyl]azo]-1H-1,2,4-triazolium acetate is predicted to be 658.866638184 mg/Kg bw/day.   Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.   Repeated dose toxicity: Inhalation   1,4-dimethyl-5-[[4-[methylbenzylamino]phenyl]azo]-1H-1,2,4-triazolium acetate has very low vapor pressure (6.35E-008 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver   Repeated dose toxicity: Dermal   The acute dermal toxicity value for 1,4-dimethyl-5-[[4-[methylbenzylamino]phenyl]azo]-1H-1,2,4-triazolium acetate (as provided in section 7.2.3) is 7228.03 mg/kg body weight. The substance was also found to be not irritating and not sensitizing to skin. Based on these considerations, the end point is considered as waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08cf47c4-0dbc-4c39-bb4c-1c59ef9e1421/documents/7ef12821-2d0e-4354-a597-1a26ab96ed35_b1792043-f86c-408c-93f7-881f4d053e45.html,,,,,, "1,4-dimethyl-5-[[4-[methylbenzylamino]phenyl]azo]-1H-1,2,4-triazolium acetate",84000-82-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08cf47c4-0dbc-4c39-bb4c-1c59ef9e1421/documents/7ef12821-2d0e-4354-a597-1a26ab96ed35_b1792043-f86c-408c-93f7-881f4d053e45.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,658.867 mg/kg bw/day,,rat "1,4-dimethyl-5-[[4-[methylbenzylamino]phenyl]azo]-1H-1,2,4-triazolium acetate",84000-82-8," Acute Oral Toxicity:  Acute oral toxicity dose was predicted based on OECD QSAR toolbox for target substance 1,4-dimethyl-5-[[4-[methylbenzylamino]phenyl]azo]-1H-1,2,4-triazolium acetate (84000-82-8) was estimated to be 3035.83mg/kg bw,and for differentstudies available on the closely related read across substance 1-Methyl-2-pyrrolidinone (872-50-4) was considered to be3914 mg/kg bw and for 1-(morpholin-4-yl)ethan-1-one (1696-20-4)was considered to be6130 mg/kg bw.All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 1,4-dimethyl-5-[[4-[methylbenzylamino]phenyl]azo]-1H-1,2,4-triazolium acetate (84000-82-8)can be classified as category V of acute oral toxicity. Acute Inhalation Toxicity:  1,4-dimethyl-5-[[4-[methylbenzylamino]phenyl]azo]-1H-1,2,4-triazolium acetate (84000-82-8) has very low vapor pressure (6.35E-008 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal Toxicity: Acute dermal toxicity dose was predicted based on OECD QSAR toolbox for target substance 1,4-dimethyl-5-[[4-[methylbenzylamino]phenyl]azo]-1H-1,2,4-triazolium acetate (84000-82-8) was estimated to be 7228.03 mg/kg bw ,and for differentstudies available on structurally similar read across substance2-[[4-(Dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride (77061-58-6) was considered to be >2000 mg/kg bw and 2-[(4-Aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride (97404-02-9) was considered to be >2000 mg/kg bw.All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 1,4-dimethyl-5-[[4-[methylbenzylamino]phenyl]azo]-1H-1,2,4-triazolium acetate (84000-82-8) can be classified as category V of acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08cf47c4-0dbc-4c39-bb4c-1c59ef9e1421/documents/cf709ce1-38ae-4265-95d6-ce35bea14592_b1792043-f86c-408c-93f7-881f4d053e45.html,,,,,, "1,4-dimethyl-5-[[4-[methylbenzylamino]phenyl]azo]-1H-1,2,4-triazolium acetate",84000-82-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08cf47c4-0dbc-4c39-bb4c-1c59ef9e1421/documents/cf709ce1-38ae-4265-95d6-ce35bea14592_b1792043-f86c-408c-93f7-881f4d053e45.html,,oral,LD50,"3,035.83 mg/kg bw",no adverse effect observed, "1,4-dimethyl-5-[[4-[methylbenzylamino]phenyl]azo]-1H-1,2,4-triazolium acetate",84000-82-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08cf47c4-0dbc-4c39-bb4c-1c59ef9e1421/documents/cf709ce1-38ae-4265-95d6-ce35bea14592_b1792043-f86c-408c-93f7-881f4d053e45.html,,dermal,LD50,"7,228.03 mg/kg bw",no adverse effect observed, "1,4-dimethylpiperazine",106-58-1,"Repeated dose toxiciy - oral: A key, K1 repeated dose toxicity study in rats was performed according to OECD guideline 407 and according to GLP requirements (Malleshappa HN, 2020). The NOAEL for systemic toxicity was considered to be 600 mg/kg bw/day. A key, K1 subchronic repeated dose toxicity study in rats was performed according to OECD guideline 408 and according to GLP requirements (Malleshappa HN, 2022). The NOAEL for systemic toxicity was considered to be 350 mg/kg bw/day.  Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure Repeated dose toxiciy - oral:A  key, K1 repeated dose toxicity study in  rats was performed according to OECD guideline 407 and according to GLP requirements (Malleshappa HN, 2020). The NOAEL for systemic toxicity was considered to be 600 mg/kg bw/day. A key, K1 subchronic repeated dose toxicity study in rats was performed according to OECD guideline 408 and according to GLP requirements (Malleshappa HN, 2022). The NOAEL for systemic toxicity was considered to be 350 mg/kg bw/day. Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56ffe744-9168-4fdd-8be4-6d45f62d0658/documents/IUC5-0556bae5-0c55-47e1-b40b-128e44416ad7_b21c817f-69c2-4a3c-b194-645ff9ae941d.html,,,,,, "1,4-dimethylpiperazine",106-58-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56ffe744-9168-4fdd-8be4-6d45f62d0658/documents/IUC5-0556bae5-0c55-47e1-b40b-128e44416ad7_b21c817f-69c2-4a3c-b194-645ff9ae941d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,>= 600 mg/kg bw/day,,rat "1,4-dimethylpiperazine",106-58-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56ffe744-9168-4fdd-8be4-6d45f62d0658/documents/IUC5-0556bae5-0c55-47e1-b40b-128e44416ad7_b21c817f-69c2-4a3c-b194-645ff9ae941d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,350 mg/kg bw/day,,rat "1,4-dimethylpiperazine",106-58-1," Acute toxicity - oral: A key, K1 acute oral toxicity test was performed in male and female Sprague Dawley rats according to OECD Guideline 401 and EPA FR, Vol.50, No. 188, 1985 (Pharmakon Research International Inc., 1990). The calculated acute oral LD50 for male and female rats treated with the test substance was determined to be 1116.2 mg/kg. Acute toxicity - inhalation: An acute inhalation study does not need to be conducted as the substance is classified as corrosive to the skin (according to REACH Annex VIII section 8.5, column 2). In addition, reliable acute oral and acute dermal toxicity studies with the test substance are available. Acute toxicity - dermal: A K1 acute dermal toxicity test was performed in male and female New Zealand White rabbits according to OECD Guideline 402 (Pharmakon Research International Inc., 1990). The dermal LD50 was determined to be 3000 mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56ffe744-9168-4fdd-8be4-6d45f62d0658/documents/IUC5-9c7f4321-4956-492d-8416-7cf3e09e7593_b21c817f-69c2-4a3c-b194-645ff9ae941d.html,,,,,, "1,4-dimethylpiperazine",106-58-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56ffe744-9168-4fdd-8be4-6d45f62d0658/documents/IUC5-9c7f4321-4956-492d-8416-7cf3e09e7593_b21c817f-69c2-4a3c-b194-645ff9ae941d.html,,oral,LD50,"1,116.2 mg/kg bw",adverse effect observed, "1,4-dimethylpiperazine",106-58-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56ffe744-9168-4fdd-8be4-6d45f62d0658/documents/IUC5-9c7f4321-4956-492d-8416-7cf3e09e7593_b21c817f-69c2-4a3c-b194-645ff9ae941d.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, "(3R,6R)-3,6-Dimethyl-1,4-dioxane-2,5-dione",13076-17-0," Lactide (18:1 mixture of L-lactide and m-lactide) was tested in dogs in a 2-week dose range finding study and a subsequent 90d full study (similar to OECD 409). The primary toxic effect was irritation of the gastrointestinal tract at 100 mg/kg bw/day in the 90d study. In addition, in an oral subchronic repeated dose toxicity study conducted with a suitable read-across partner, calcium lactate was used to assess the specific target organ toxicity of the target substance. Based on the results, no classification for specific target organ toxicity is warranted for D-lactide. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dcc70939-f5d8-4548-88ea-afc87eb1bc66/documents/IUC5-52e00828-df24-4327-b1f3-8d9c160e6cad_85893d70-6c3c-4320-8f60-1ffa0834111b.html,,,,,, "(3R,6R)-3,6-Dimethyl-1,4-dioxane-2,5-dione",13076-17-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dcc70939-f5d8-4548-88ea-afc87eb1bc66/documents/IUC5-52e00828-df24-4327-b1f3-8d9c160e6cad_85893d70-6c3c-4320-8f60-1ffa0834111b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,dog "(3R,6R)-3,6-Dimethyl-1,4-dioxane-2,5-dione",13076-17-0,"A sample of D-lactide was examined for acute oral toxicity in an experiment conducted according to OECD guideline 423 with female rats. A dose level of 2000 mg/kg body weight was examined. No mortality or distinct clinical signs were observed after treatment of 6 females with the 2000 mg/kg bw dose level.In an acute dermal toxicity study (limit test), a group of young adult Wistar rats (5 males and 5 females) was dermally exposed to D-lactide in polyethylene glycol 400 for 24 hours to approximately 10% of body surface area at a dose level of 2000 mg/kg bw. Animals were observed for 14 days. No mortality occurred. There were no treatment related clinical signs, necropsy findings or changes in body weight.Lactic acid is used as a read-across partner for D-lactide and in an acute inhalation toxicity study in rats with lactic acid a LC50 of > 7.94 mg/L air was determined. Based on the results, no classification for acute toxicity is warranted. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcc70939-f5d8-4548-88ea-afc87eb1bc66/documents/IUC5-27004092-0f0d-4035-b0ba-fcb90f1399a9_85893d70-6c3c-4320-8f60-1ffa0834111b.html,,,,,, "(3R,6R)-3,6-Dimethyl-1,4-dioxane-2,5-dione",13076-17-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcc70939-f5d8-4548-88ea-afc87eb1bc66/documents/IUC5-27004092-0f0d-4035-b0ba-fcb90f1399a9_85893d70-6c3c-4320-8f60-1ffa0834111b.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(3R,6R)-3,6-Dimethyl-1,4-dioxane-2,5-dione",13076-17-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcc70939-f5d8-4548-88ea-afc87eb1bc66/documents/IUC5-27004092-0f0d-4035-b0ba-fcb90f1399a9_85893d70-6c3c-4320-8f60-1ffa0834111b.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(3R,6R)-3,6-Dimethyl-1,4-dioxane-2,5-dione",13076-17-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcc70939-f5d8-4548-88ea-afc87eb1bc66/documents/IUC5-27004092-0f0d-4035-b0ba-fcb90f1399a9_85893d70-6c3c-4320-8f60-1ffa0834111b.html,,inhalation,LC50,"> 7,940 mg/m3",adverse effect observed, "8-[4-(4-Methylphenyl)-3-cyclohexen-1-yl]-1,4-dioxaspiro[4.5]decane",125962-78-9,"In a repeated dose toxicity study combined with the reproduction/developmental toxicity screening test according to OECD guideline 422, the LOAEL (systemic) was found to be 100 mg/kg bw/day. Thus, the test item ist considered to be classified for special target organ toxicity, repeated dose, category 2 (reference 7.5.1-1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline study under GLP conditions ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/189ff984-4f35-4c3c-b1d6-94f60dbebdfa/documents/626f4a99-2d34-4b19-b914-3a19c2f7bee4_88a2c5f3-4433-4bd1-948e-e5a6f6421b26.html,,,,,, "8-[4-(4-Methylphenyl)-3-cyclohexen-1-yl]-1,4-dioxaspiro[4.5]decane",125962-78-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/189ff984-4f35-4c3c-b1d6-94f60dbebdfa/documents/626f4a99-2d34-4b19-b914-3a19c2f7bee4_88a2c5f3-4433-4bd1-948e-e5a6f6421b26.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat "8-[4-(4-Methylphenyl)-3-cyclohexen-1-yl]-1,4-dioxaspiro[4.5]decane",125962-78-9,"Based on the results of an acute oral toxicity study according to OECD guideline 423, the LD50 value of the test item is higher than 2000 mg/kg bw after single oral administration in rats. It is concluded that the test material has no acute toxic potential up to the limit dose of 2000 mg/kg bw (reference 7.2.1-1). Mortality after dermal exposure to the test item is not expected as the key acute oral toxicity study showed no effects up to the limit dose of 2000 mg/kg bw and physicochemical properties of the test substance suggest a very low dermal absorption. A study for acute inhalation toxicity does not need to be conducted because exposure of humans via inhalation is unlikely. For this reason, further acute inhalation and dermal toxicity studies will be waived (reference 7.2.2-1 and 7.2.3-1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): This study was performed according to GLP and the methods applied are fully compliant with OECD TG 423. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/189ff984-4f35-4c3c-b1d6-94f60dbebdfa/documents/d943ac2e-185b-42b7-b506-e848e0237e9a_88a2c5f3-4433-4bd1-948e-e5a6f6421b26.html,,,,,, "8-[4-(4-Methylphenyl)-3-cyclohexen-1-yl]-1,4-dioxaspiro[4.5]decane",125962-78-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/189ff984-4f35-4c3c-b1d6-94f60dbebdfa/documents/d943ac2e-185b-42b7-b506-e848e0237e9a_88a2c5f3-4433-4bd1-948e-e5a6f6421b26.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,4-naphthoquinone",130-15-4, A reliable OECD 422 study is available conducted in compliance with GLP. This provided a NOAEL to rats of 2 mg/kg when considering repeated dose endpoints. This was the highest feasible concentration deemed appropriate for dosing owing to the corrosive nature of the substance. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/52c74e9b-2446-4b09-920d-90cdeac1e320/documents/e6bf7a20-21f2-427c-8abf-adcd2aad9d71_00c4d9bc-40cf-4d55-9d41-b6628fb71e3c.html,,,,,, "1,4-naphthoquinone",130-15-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/52c74e9b-2446-4b09-920d-90cdeac1e320/documents/e6bf7a20-21f2-427c-8abf-adcd2aad9d71_00c4d9bc-40cf-4d55-9d41-b6628fb71e3c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,2 mg/kg bw/day,,rat "1,4-naphthoquinone",130-15-4," An acute oral toxicity study is available for the substance which indicates that the substance is toxic to rats via the oral route. An acute study conducted via the inhalation route is also available indicating the the substance is toxic to rats via this route. However, the experimental data and test report is not available and accordingly this is only used in the consideration of Classification and Labelling. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52c74e9b-2446-4b09-920d-90cdeac1e320/documents/97f2bc27-e2f2-4543-948b-47bb07da3860_00c4d9bc-40cf-4d55-9d41-b6628fb71e3c.html,,,,,, "1,4-naphthoquinone",130-15-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52c74e9b-2446-4b09-920d-90cdeac1e320/documents/97f2bc27-e2f2-4543-948b-47bb07da3860_00c4d9bc-40cf-4d55-9d41-b6628fb71e3c.html,,oral,LD50,124 mg/kg bw,adverse effect observed, "1,4-phenylene bis((4-hydroxyphenyl)methanone)",15517-46-1," No repeated dose toxicity study is available for 1,4-Bis (4-hydroxy benzoyl) benzene and therefore the results of a sub-acute toxicity study with the structural analogue 1,3-Bis (4-hydroxy benzoyl) benzene are used instead (for details see Read-across justification as attached in section 13). In an OECD 422 test guideline study, Wistar Han rats were treated with 1,3-Bis (4-hydroxy benzoyl) benzene by daily oral gavage at dose levels of 100, 300 and 1000 mg/kg/day. The rats of the control group received the vehicle, 1% aqueous carboxymethyl cellulose, alone. Males were treated for a total of 29 days. Females that delivered offspring were treated for a total of 50-63 days. Females that failed to deliver pups were treated for 43-54 days. The main finding in parental animals was a retinal atrophy of the eyes in 2/5 females at the highest dose level tested (1000 mg/kg/day), at minimal degree. Retinal atrophy is a finding which is occasionally observed in control rats, however, as the lesion was not present in the control group of the current study, a relation with treatment cannot be excluded. Since the eye can be seen as part of the central nervous system with very limited to no regenerative capacity, this finding was considered adverse. There were no toxicologically significant changes in any reproductive parameters examined. In the offspring, developmental toxicity was observed at the highest dose level tested (1000 mg/kg/day). Body weights of female and male pups were decreased from PND 4. As no recovery in body weights was or could be observed beyong this time point, these decreases were considered adverse. A shift towards more males than females was observed at 1000 mg/kg/day and was considered non adverse in absence of effects on anogenital distance, thyroid hormone levels and nipple retention. As the shift towards more males than females was present in most litters (7 out of 8 litters), a test item related effect could not be excluded. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f4dbdf8-937c-4163-8107-386d81b9ee0a/documents/a3541cf9-2180-4019-a003-80a858811e53_2ecbb8bc-526d-4ccf-b0aa-854b26b90fff.html,,,,,, "1,4-phenylene bis((4-hydroxyphenyl)methanone)",15517-46-1,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f4dbdf8-937c-4163-8107-386d81b9ee0a/documents/a3541cf9-2180-4019-a003-80a858811e53_2ecbb8bc-526d-4ccf-b0aa-854b26b90fff.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "1,4-phenylene bis((4-hydroxyphenyl)methanone)",15517-46-1," - Acute oral toxicity: LD50 (female) > 2000 mg/kg bw (OECD 423, GLP, K, Rel. 1) ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f4dbdf8-937c-4163-8107-386d81b9ee0a/documents/633f11bd-d552-4799-82e0-225730caf2bd_2ecbb8bc-526d-4ccf-b0aa-854b26b90fff.html,,,,,, "1,4-phenylene bis((4-hydroxyphenyl)methanone)",15517-46-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f4dbdf8-937c-4163-8107-386d81b9ee0a/documents/633f11bd-d552-4799-82e0-225730caf2bd_2ecbb8bc-526d-4ccf-b0aa-854b26b90fff.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-(4-(3-Dodecanoyloxy-2,2-dimethylpropylideneamino)phenylimino)-2,2-dimethylpropyl dodecanoate",1154521-93-3, The test item was tested for its acute oral toxicity with rats according to OECD guideline 423. The LD50 was determined to be between 300 mg/kg bw and 2000 mg/kg bw.   ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69b1f042-fa25-4880-b00b-11294d3ac27a/documents/IUC5-c9367bcd-d2a5-42e7-aaee-cb6338c7f026_6aac776a-4bbd-4e81-9fa7-413241fd7c59.html,,,,,, "3-(4-(3-Dodecanoyloxy-2,2-dimethylpropylideneamino)phenylimino)-2,2-dimethylpropyl dodecanoate",1154521-93-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69b1f042-fa25-4880-b00b-11294d3ac27a/documents/IUC5-c9367bcd-d2a5-42e7-aaee-cb6338c7f026_6aac776a-4bbd-4e81-9fa7-413241fd7c59.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "1,4-α-glucan branching enzyme",9001-97-2," The highest concentration (undiluted concentrate) of 1,4-alpha-glucan branching enzyme, batch PPY 27209 did not cause any adverse changes in any of the investigated parameters in the sub-chronic toxicity study in rats. Therefore, the no-observed-adverse-effect level (NOAEL) for 1,4-alpha-glucan branching enzyme, batch PPY 27209 was considered to be 1128 mg Dry matter/kg bw/day for both sexes. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/491ba31a-6dc2-4cb7-a83f-457101195f43/documents/8745a86c-d995-4143-8995-63b1115db3ac_f3bdf8c6-c975-4453-9427-c2e683d66717.html,,,,,, "1,4-α-glucan branching enzyme",9001-97-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/491ba31a-6dc2-4cb7-a83f-457101195f43/documents/8745a86c-d995-4143-8995-63b1115db3ac_f3bdf8c6-c975-4453-9427-c2e683d66717.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,128 mg/kg bw/day",,rat "1,4-α-glucan branching enzyme",9001-97-2," 1,4-alpha-glucan branching enzyme was not tested for acute oral toxicity, however, a repeated dose 13-week oral toxicity was available. The administration of 1,4-alpha-glucan branching enzyme, batch PPY27209 at dosages between 1128 mg Dry matter/kg bw/day for 13 weeks did not produce any evidence of toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/491ba31a-6dc2-4cb7-a83f-457101195f43/documents/125c1527-8c95-4c10-9ed9-09ae0af23229_f3bdf8c6-c975-4453-9427-c2e683d66717.html,,,,,, "1,5,2,4-dioxadithiane 2,2,4,4-tetraoxide",99591-74-9,A reliable combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test of MMDS in rats by oral gavage is available. ,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/be16621f-8fc9-48e0-9494-15061afd7710/documents/IUC5-0c9323d7-7e9f-4c6f-85f0-8e35a45c1cd8_e213fb42-4871-43a6-a2c2-67b51232e0d8.html,,,,,, "1,5,2,4-dioxadithiane 2,2,4,4-tetraoxide",99591-74-9,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/be16621f-8fc9-48e0-9494-15061afd7710/documents/IUC5-0c9323d7-7e9f-4c6f-85f0-8e35a45c1cd8_e213fb42-4871-43a6-a2c2-67b51232e0d8.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,10 mg/kg bw/day,,rat "1,5,2,4-dioxadithiane 2,2,4,4-tetraoxide",99591-74-9,One key study on acute oral toxicity is available. The study was conducted using female Wistar rats and was conducted according to the Acute Toxic Class Method (OECD Guideline 423).One key study on acute dermal toxicity is available. The study was conducted using male and female Wistar rats and was conducted according to the standard acute method (OECD Guideline 402).One key study on acute inhalation toxicity is available. The study was conducted using male and female Wistar rats and was conducted according to the standard acute method (OECD Guideline 403). ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be16621f-8fc9-48e0-9494-15061afd7710/documents/IUC5-60697cfc-a75a-4a58-974b-989553285e38_e213fb42-4871-43a6-a2c2-67b51232e0d8.html,,,,,, "1,5,2,4-dioxadithiane 2,2,4,4-tetraoxide",99591-74-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be16621f-8fc9-48e0-9494-15061afd7710/documents/IUC5-60697cfc-a75a-4a58-974b-989553285e38_e213fb42-4871-43a6-a2c2-67b51232e0d8.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "1,5,2,4-dioxadithiane 2,2,4,4-tetraoxide",99591-74-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be16621f-8fc9-48e0-9494-15061afd7710/documents/IUC5-60697cfc-a75a-4a58-974b-989553285e38_e213fb42-4871-43a6-a2c2-67b51232e0d8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,5,2,4-dioxadithiane 2,2,4,4-tetraoxide",99591-74-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be16621f-8fc9-48e0-9494-15061afd7710/documents/IUC5-60697cfc-a75a-4a58-974b-989553285e38_e213fb42-4871-43a6-a2c2-67b51232e0d8.html,,inhalation,LC50,50 mg/m3,adverse effect observed, "1,5-bis(cyclohexylamino)anthraquinone",15958-68-6,"LD50 was estimated to be 4025 mg/kg bw when Fischer 344 rats were orally exposed with 1,5-bis(cyclohexylamino)-9,10-dihydroanthracene-9,10-dione.   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/690df3a0-9e2c-4d4f-91a7-0d541012416d/documents/b4b466d6-6169-48da-badb-94627520684e_25e437ff-dbfa-4f6b-8020-a3c2bb246149.html,,,,,, "1,5-bis(cyclohexylamino)anthraquinone",15958-68-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/690df3a0-9e2c-4d4f-91a7-0d541012416d/documents/b4b466d6-6169-48da-badb-94627520684e_25e437ff-dbfa-4f6b-8020-a3c2bb246149.html,,oral,LD50,"4,025 mg/kg bw",no adverse effect observed, "1,5-naphthylene diisocyanate",3173-72-6,"Inhalation Exposure Route   In a sub-chronic toxicity study according to OECD TG 413 (Pauluhn, 2010) 10 male and 10 female Wistar rats per concentration group were nose-only exposed for 13 weeks (6 hours /day, 5 days/week) to a solid aerosol of 1,5-Naphthylene diisocyanate (NDI). The mean actual breathing zone concentrations (gravimetric) were 0.065, 0.25, 1.02 and 3.96 mg/m3. Rats exposed under otherwise identical test conditions served as concurrent control group. Additional 10 male and 10 female rats in the air control and high concentration exposure group  were allowed to recover during a 4-week post-exposure period. The rats exposed up to and including 1.02 mg/m3 did not display any clinical effects attributable to the test substance. At 3.96 mg/m3 animals displayed responses, such as bradypnea, irregular and laboured breathing patterns, dyspnoea, breathing sounds, stridor, nasal discharge (serous), nostrils: red encrustations, eye lids: red encrustations, motility reduced, limp, high-legged gait, cyanosis, piloerection, haircoat ungroomed, and bloated abdomen. In regard to visible signs of respiratory tract irritation, female rats appeared to be slightly more susceptible than male rats. Conclusive changes in body temperature, reflexes, body weights or food/water consumption did not occur. Ophthalmology was unobtrusive. There was no evidence of adverse haematological effects and clinical-pathology did not provide patho-diagnostically relevant evidence of NDI-aerosol induced effects. However, an isolated increase in total bilirubin was observed at 3.96 mg/m3 (trend in males, and significant elevations in females). Urinalysis was unremarkable. There were no statistically significant or conclusive changes in absolute or relative organ weights of adrenals, brain, epididymites, kidneys, liver, ovaries, spleen, testes, and thymus. However, at 1.02 and 3.96 mg/m3 , lung weights were significantly increased. In addition, significantly increased heart weights occurred in female rats exposed at 3.96 mg/m3. The elevations in organ weights were not reversible with the 4-week post-exposure period. After 13-weeks, minimal to slight histopathological findings observed in the nasal cavities, pharynx, larynx, trachea and lungs of rats exposed at 1.02 and 3.96 mg/m3 . In the nasal cavities findings were characterized by epithelial degeneration and/or atrophy, goblet cell hyperplasia and increased inflammatory infiltrates. As can be appreciated from the degree of responses at the level I and IV of the nasal cavities, there is an apparent equal susceptibility of regions with respiratory epithelium and olfactory epithelium. This lack of specificity supports a non-specific irritant mechanism. Likewise, also laryngeal epithelium shows irritant-related changes ranging from epithelial alterations, focal inflammatory infiltrations to epithelial squamous metaplasia especially at the ventral aspect of the larynx. In the lungs, bronchiolo-alveolar hypercellularity, minimal septal thickening, inflammatory infiltrates and increased alveolar macrophages with foamy appearance occurred. In addition, females of the dose group 0.25 mg/m3 showed minimal focal inflammatory infiltrations and epithelial alterations in the larynx. After 4 weeks of recovery, in the nasal cavities minimal or slight degeneration and/or atrophy of the olfactory epithelium was still apparent in all rats from the high dose group 3.96 mg/m3. Additionally, unusual nerve-like structures were obvious in the epithelium and neuronal degeneration of nerve bundles was detected in the lamina propria. In the lungs, minimal hypercellularity of the bronchiolo-alveolar region, an increased amount of macrophages and an increased incidence of minimal inflammatory infiltrates was still seen. Histopathological findings of the pharynx, larynx, and trachea recovered entirely. Overall, there was a tendency that female rats were mildly more susceptible than male ones. No respiratory tract lesions were still apparent in male and female rats at 0.25 and 1.02 mg/m3 after the 4-week recovery period. In summary, this study demonstrates that the test substance causes respiratory tract irritation. The localization of irritation depends on the site of initial deposition and associated local response. Based on portal-of-entry-related endpoints NDI was tolerated without any local or systemic adverse effects up to 0.25 mg/m3. Conclusive evidence of respiratory irritation occurred at 1.02 and 3.96 mg/m3. With regard to histopathological changes, all changes observed were related to portal-of-entry; local irritant effects (nasal passages, larynx, airways and alveoli), i.e, changes that occurred at anatomical structures, to some extent rat-specific, favouring focal deposition of irritant particulates. The minimal laryngeal findings observed in female rats at 0.25 mg/m3 are assessed to be non-adverse. According to the publication of Kaufmann et al. (2009)1 minimal focal epithelial changes of the laryngeal epithelium are assessed as non-adverse since they may also occur in non-treated animals and were not considered to have a potential for a laryngeal dysfunction. Also, cases of minimal to slight laryngeal squamous metaplasia that are not observed diffusely could occur spontaneously or as treatment-induced lesions and should be assessed as non-adverse. Based on the rationale given, taking all findings into account, 0.25 mg/m3 constitutes a no-observed-adverse-effect-concentration (NOAEC) based on effects related to respiratory tract irritation. 1 Kaufmann et al. (2009): 1st International ESTP Expert Workshop: Larynx squamous metaplasia - A re-consideration of morphology and diagnostic approaches in rodent studies and its relevance for human risk assessment. Experimental and Toxicologic Pathology 61: 591 -603. Dermal Exposure Route No data available. Oral Exposure Route No data available. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac3db87b-5ad9-47b1-baa0-dd91609c99fe/documents/4ab8d9b6-a3f6-489a-a2f3-97cbb5675cf2_cb3c376e-1159-4f66-813e-46cf93efb964.html,,,,,, "1,5-naphthylene diisocyanate",3173-72-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac3db87b-5ad9-47b1-baa0-dd91609c99fe/documents/4ab8d9b6-a3f6-489a-a2f3-97cbb5675cf2_cb3c376e-1159-4f66-813e-46cf93efb964.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.25 mg/m3,,rat "1,5-naphthylene diisocyanate",3173-72-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac3db87b-5ad9-47b1-baa0-dd91609c99fe/documents/4ab8d9b6-a3f6-489a-a2f3-97cbb5675cf2_cb3c376e-1159-4f66-813e-46cf93efb964.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.25 mg/m3,adverse effect observed,rat "1,5-naphthylene diisocyanate",3173-72-6,"Acute toxicity: oral The acute oral toxicity was low with an LD50 value exceeding 5000 mg/kg bw in rats (cut-off value) according to OECD TG 423 (Schuengel, 2006a). At a test dose of 2000 mg/kg bw no animal died and no clinical signs were observed during the 14-day post observation period. Based on the available study data NDI is regarded as relatively non-toxic for the endpoint acute oral toxicity and is not classified according EU GHS 1272/2008 CLP.   Acute toxicity: dermal No study data available for NDI.   Acute toxicity: inhalation The acute LC50 of NDI was 270 mg/m3 (0.27 mg/l) in rats for a 4-hour aerosol exposure according to OECD TG 403 (Pauluhn, 1995a). Exposure to concentrations of 96 mg/m3 and higher were followed by concentration-dependent signs suggestive of irritation of the respiratory tract (e.g. bradypnea, dyspnoea, laboured breathing pattern, rales, nose/snout area with red encrustations, serous discharge from nose, cyanosis, hypothermia) and non-specific signs such as reduced motility, body weight gain, emaciation, and flaccid muscle tone. Exposure to concentrations equal or less than 189 mg/m3 test compound were tolerated without mortality. Necropsy findings support the conclusion that a causal relationship between lethality and lung damage existed. A further acute inhalation study in rats (OECD TG 403; Pauluhn, 2003) was conducted to analyse bronchoalveolar lavage (BAL) parameters following a single 4-hour exposure (nose-only) to NDI concentrations of 56 to 1050 mg/m3 air using a solid aerosol with variable respirability (MMAD ranging from 3 -10 µm). This study suggests that respirable NDI aerosol appears to interact directly with the air-blood barrier causing a temporarily increased extravasation of plasma proteins as a result of a transiently permeability of the capillary endothelial cells. The data show unequivocally that not the concentration per se rather than the concentration of actually respirable particulates (i.e., these are those penetrating the alveolar region) is most important for the elicitation of irritant-related acute toxicity (mortality). These results support the conclusion that for hazard characterization both the concentration as well as the respirability of NDI dust needs to be considered. Acute inhalation of NDI was evaluated in a third acute inhalation toxicity study by Pauluhn (1995b).  For transportation guideline requirements, male and female Wistar rats were exposed to  NDI  dust for 1 hour to concentration of  1285 mg/m3 or 2075 mg/m3*. Animals of the control group were exposed to conditioned air almost  similar exposure conditions were used as for the test substance groups. Signs of respiratory tract irritation were noted in animals treated one hour with the test substance Desmodur 15 (NDI), indicated by bradypnea, dyspnoea, laboured breathing pattern, rales, nose/snout area with red encrustations, serous discharge from nose, cyanosis. One hour exposure with the test substance was tolerated in female rats without mortality, in males one male (1/5 males) died at 1285 mg/m3. At the high dose group of 2075 mg/m3 no mortality was indicated; under the test conditions used* no LC50 value could be derived. 1,5-naphthylene diisocyanate (NDI) is harmonised classified as Acute Tox. 2 (H330: fatal if inhaled) according to Annex VI Regulation (EC) No 1272/2008 (CLP Regulation), ATP 18 (index number 615-050-004, 1,5-naphylene diisocyanate [containing ≥ 0.1% (w/w) of particle with an aerodynamic diameter of below 50µm]. *Note: The aerosol generated was of low respirability in the 1285 and 2075 mg/m3 exposure groups (1285 mg/m3 air: MMAD 4.6 µm, GSD ca. 1.6, relative mass < 3 µm ca. 19% 2075 mg/m3 air: MMAD 8.1 µm, GSD ca. 1.7, relative mass < 3 µm ca. 7 %). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac3db87b-5ad9-47b1-baa0-dd91609c99fe/documents/b389ab89-673d-466f-8e13-99eaad71758b_cb3c376e-1159-4f66-813e-46cf93efb964.html,,,,,, "1,5-naphthylene diisocyanate",3173-72-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac3db87b-5ad9-47b1-baa0-dd91609c99fe/documents/b389ab89-673d-466f-8e13-99eaad71758b_cb3c376e-1159-4f66-813e-46cf93efb964.html,,oral,LD50,">=5,000 mg/kg bw",no adverse effect observed, "1,5-naphthylene diisocyanate",3173-72-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac3db87b-5ad9-47b1-baa0-dd91609c99fe/documents/b389ab89-673d-466f-8e13-99eaad71758b_cb3c376e-1159-4f66-813e-46cf93efb964.html,,inhalation,LC50,270 mg/m3,adverse effect observed, "1,5-Pentanediamine, 2-methyl-, reaction products with 2-ethyl-1,4-butanediamine and glycidyl tolyl ether",90480-76-5,"Screening study: The oral administration of CGE-PMDA adduct to rats by gavage, at dose levels of 25, 75 and 150 mg/kg bw/day, resulted in a reduction in body weight gain and food consumption in animals of either sex at 150 and 75 mg/kg bw/day. Following the reduction of the high dose level to 100 mg/kg bw/day on Day 15, recovery was evident in these animals and body weight gains also improved at 75 mg/kg bw/day from Week 3 onwards. Treated animals also showed clinical observations that can be associated with the oral administration of an irritant/unpalatable test item formulation and as such, the initial reduced body weight development at 150 and 75 mg/kg bw/day may be the result of the irritant nature of the test item rather than evidence of true systemic toxicity. The microscopic changes evident in the mesenteric lymph nodes were considered to be non-adverse and although the significance of the microscopic seminal vesicle and coagulating gland changes were unclear, there was no evidence of any degeneration or any effect on fertility and complete reversibility was evident. Therefore the ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was considered to be 100 mg/kg bw/day for both males and females. The `No Observed Effect Level' (NOEL) for reproductive toxicity was considered to be 100 mg/kg bw/day. Subchronic toxicity study: Due to the premature sacrifice of two males administered 125 mg/kg/day as well as the adverse reduction of body weight gain, microscopic changes of the skeletal muscle and associated changes in clinical pathology and grip strength observed in males and females administered 125 mg/kg/day, the No Observed Adverse Effect Level (NOAEL) of CGE-PMDA adduct in Han Wistar rats after 13 weeks of treatment is 62.5 mg/kg/day for both sexes. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fcaba65-64aa-4290-8b39-d5fc0f1677f0/documents/f7011e28-ebe0-4204-a776-11af52a83450_7376d0b6-66bc-4f26-9ee6-abdd6cdfd2ae.html,,,,,, "1,5-Pentanediamine, 2-methyl-, reaction products with 2-ethyl-1,4-butanediamine and glycidyl tolyl ether",90480-76-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fcaba65-64aa-4290-8b39-d5fc0f1677f0/documents/f7011e28-ebe0-4204-a776-11af52a83450_7376d0b6-66bc-4f26-9ee6-abdd6cdfd2ae.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1,5-Pentanediamine, 2-methyl-, reaction products with 2-ethyl-1,4-butanediamine and glycidyl tolyl ether",90480-76-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fcaba65-64aa-4290-8b39-d5fc0f1677f0/documents/f7011e28-ebe0-4204-a776-11af52a83450_7376d0b6-66bc-4f26-9ee6-abdd6cdfd2ae.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,62.5 mg/kg bw/day,,rat "1,5-Pentanediamine, 2-methyl-, reaction products with 2-ethyl-1,4-butanediamine and glycidyl tolyl ether",90480-76-5," LD50 in the range of 50 - 300 mg/kg bw (rat, OECD TG 420)   Acute inhalation toxicity: no study available; exposure considerations Acute dermal toxicity: LD50 could not accurately evaluated due to the corrosive nature of the test item ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fcaba65-64aa-4290-8b39-d5fc0f1677f0/documents/10c9e7ae-54de-4bda-af1a-f496342d2b64_7376d0b6-66bc-4f26-9ee6-abdd6cdfd2ae.html,,,,,, "1,5-Pentanediamine, 2-methyl-, reaction products with 2-ethyl-1,4-butanediamine and glycidyl tolyl ether",90480-76-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fcaba65-64aa-4290-8b39-d5fc0f1677f0/documents/10c9e7ae-54de-4bda-af1a-f496342d2b64_7376d0b6-66bc-4f26-9ee6-abdd6cdfd2ae.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "1,6,7,8,9,14,15,16,17,17,18,18-dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene",13560-89-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7053ff24-6f58-46f8-b799-007ab2c2ee61/documents/IUC5-bf175b8f-89d6-4cd2-a609-584ed97a4315_d38f5980-ac95-4884-a3b4-b54c29452f54.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rabbit "1,6,7,8,9,14,15,16,17,17,18,18-dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene",13560-89-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7053ff24-6f58-46f8-b799-007ab2c2ee61/documents/IUC5-bf175b8f-89d6-4cd2-a609-584ed97a4315_d38f5980-ac95-4884-a3b4-b54c29452f54.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,1 mg/m3,,rat "1,6,7,8,9,14,15,16,17,17,18,18-dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene",13560-89-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7053ff24-6f58-46f8-b799-007ab2c2ee61/documents/IUC5-bf175b8f-89d6-4cd2-a609-584ed97a4315_d38f5980-ac95-4884-a3b4-b54c29452f54.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"5,870 mg/kg bw/day",,rat "1,6,7,8,9,14,15,16,17,17,18,18-dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene",13560-89-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7053ff24-6f58-46f8-b799-007ab2c2ee61/documents/IUC5-bf175b8f-89d6-4cd2-a609-584ed97a4315_d38f5980-ac95-4884-a3b4-b54c29452f54.html,Repeated dose toxicity – local effects,dermal,NOAEL,12 mg/cm2,no adverse effect observed,rabbit "1,6,7,8,9,14,15,16,17,17,18,18-dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene",13560-89-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7053ff24-6f58-46f8-b799-007ab2c2ee61/documents/IUC5-bf175b8f-89d6-4cd2-a609-584ed97a4315_d38f5980-ac95-4884-a3b4-b54c29452f54.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1 mg/m3,no adverse effect observed,rat "1,6,7,8,9,14,15,16,17,17,18,18-dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene",13560-89-9,"Groups of 2 rabbits each were applied with dose levels of 500, 1,000, 2,000, 4,000, or 8,000 mg/kg bw of Dechlorane Plus on the intact or abraded skin. No substance-related effect at all was seen in any of the 20 rabbits used. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7053ff24-6f58-46f8-b799-007ab2c2ee61/documents/IUC5-98ffd74b-f003-4243-bfa0-59f2212ee26d_d38f5980-ac95-4884-a3b4-b54c29452f54.html,,,,,, "1,6,7,8,9,14,15,16,17,17,18,18-dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene",13560-89-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7053ff24-6f58-46f8-b799-007ab2c2ee61/documents/IUC5-98ffd74b-f003-4243-bfa0-59f2212ee26d_d38f5980-ac95-4884-a3b4-b54c29452f54.html,,oral,,"25,000 mg/kg bw",no adverse effect observed, "1,6,7,8,9,14,15,16,17,17,18,18-dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene",13560-89-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7053ff24-6f58-46f8-b799-007ab2c2ee61/documents/IUC5-98ffd74b-f003-4243-bfa0-59f2212ee26d_d38f5980-ac95-4884-a3b4-b54c29452f54.html,,dermal,,"8,000 mg/kg bw",no adverse effect observed, "1,6,7,8,9,14,15,16,17,17,18,18-dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca-7,15-diene",13560-89-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7053ff24-6f58-46f8-b799-007ab2c2ee61/documents/IUC5-98ffd74b-f003-4243-bfa0-59f2212ee26d_d38f5980-ac95-4884-a3b4-b54c29452f54.html,,inhalation,,"2,250 mg/m3",no adverse effect observed, "1,6-bis((dibenzylthiocarbamoyl)disulfanyl)hexane",151900-44-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP and OECD Guideline study ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/155c7b01-4c95-4f2f-bd2e-e913aa8a70c4/documents/IUC5-b9cd2bf0-4854-4eac-8247-cd688663fb70_ae5f6d46-58a5-42a7-8f83-1137278bdca2.html,,,,,, "1,6-bis((dibenzylthiocarbamoyl)disulfanyl)hexane",151900-44-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/155c7b01-4c95-4f2f-bd2e-e913aa8a70c4/documents/IUC5-b9cd2bf0-4854-4eac-8247-cd688663fb70_ae5f6d46-58a5-42a7-8f83-1137278bdca2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,6-bis((dibenzylthiocarbamoyl)disulfanyl)hexane",151900-44-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP guideline study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): GLP guideline study ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/155c7b01-4c95-4f2f-bd2e-e913aa8a70c4/documents/IUC5-051bd8cb-c4a1-4d0f-b0c0-4c75bf2c5da1_ae5f6d46-58a5-42a7-8f83-1137278bdca2.html,,,,,, "1,6-bis((dibenzylthiocarbamoyl)disulfanyl)hexane",151900-44-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/155c7b01-4c95-4f2f-bd2e-e913aa8a70c4/documents/IUC5-051bd8cb-c4a1-4d0f-b0c0-4c75bf2c5da1_ae5f6d46-58a5-42a7-8f83-1137278bdca2.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,6-bis((dibenzylthiocarbamoyl)disulfanyl)hexane",151900-44-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/155c7b01-4c95-4f2f-bd2e-e913aa8a70c4/documents/IUC5-051bd8cb-c4a1-4d0f-b0c0-4c75bf2c5da1_ae5f6d46-58a5-42a7-8f83-1137278bdca2.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,6-dichlorohexane",2163-00-0,"A reproduction/developmental toxicity screening test was performed with 1,6-dichlorohexane according to OECD guideline no. 421.The following no-observed-effect levels (NOAEL) of the test item were noted:The NOAEL (no-observed-adverse-effect level) on the F0-generation was 210 mg/kg bw/day, p.o.. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b7482f1-c552-440b-bbc3-05b6a7075a7e/documents/IUC5-40a9a4de-4af0-46ea-925b-1477488c48c2_b24e5f86-11d0-46af-acd2-f390500dcae1.html,,,,,, "1,6-dichlorohexane",2163-00-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b7482f1-c552-440b-bbc3-05b6a7075a7e/documents/IUC5-40a9a4de-4af0-46ea-925b-1477488c48c2_b24e5f86-11d0-46af-acd2-f390500dcae1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,210 mg/kg bw/day,,rat "1,6-dichlorohexane",2163-00-0,The test item was tested for acute oral toxicity and for acute dermal toxicity. The test item revealed an oral LD50 approximately 2675 mg/kg bw in rats. The test item revealed a dermal LD50 greater 2000 mg/kg bw in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b7482f1-c552-440b-bbc3-05b6a7075a7e/documents/IUC5-e7580f84-3240-4a65-9452-09872945779a_b24e5f86-11d0-46af-acd2-f390500dcae1.html,,,,,, "1,6-dichlorohexane",2163-00-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b7482f1-c552-440b-bbc3-05b6a7075a7e/documents/IUC5-e7580f84-3240-4a65-9452-09872945779a_b24e5f86-11d0-46af-acd2-f390500dcae1.html,,oral,LD50,"2,675 mg/kg bw",adverse effect observed, "1,6-dichlorohexane",2163-00-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b7482f1-c552-440b-bbc3-05b6a7075a7e/documents/IUC5-e7580f84-3240-4a65-9452-09872945779a_b24e5f86-11d0-46af-acd2-f390500dcae1.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,6-diiodoperfluorohexane",375-80-4,"The substance induced significant decrease in body weight and food consumption by both the oral and inhalation routes. Similar effects were observed for both exposure routes: altered organ organ weights (liver, kidney, brain, adrenals, testes, epididymis, thymus), altered haematological parameters (in particular red blood cells and hemoglobin levels). In addition, in the oral study, the prostate and seminal vesicles weights were found lower in all treated groups, while the weight of lungs, thyroid and hypophysis were increased. White blood cells and lymphocytes were also found decreased.Histopathological examinations showed effects in liver, thymus, male and femal reproductive organs. In males, decreased activity of Inhibin B in the 2 higher dose groups of the 28-day inhalation study was consistent with testicular damage. The liver effects may represent an adaptative response as evidenced by increased liver weight, liver enlargement, hepatocytes hypertrophy or swelling, decreased cholesterol levels and increased total proteins. In the inhalation study, analysis of thyroid hormones showed a decrease in T3 at the high dose, and increased levels of T4 in all dose groups, consistent with the inhibition of 5'-deiodinase activity observed in vitro in rat hepatocytes. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93e79a1b-b3b8-42a6-856a-d17549688a17/documents/IUC5-4df95bb3-d51a-48dc-9541-97d35118938e_79958d2a-419a-429d-aa6b-1e86b833f68f.html,,,,,, "1,6-diiodoperfluorohexane",375-80-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93e79a1b-b3b8-42a6-856a-d17549688a17/documents/IUC5-4df95bb3-d51a-48dc-9541-97d35118938e_79958d2a-419a-429d-aa6b-1e86b833f68f.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,1 mg/kg bw/day,,rat "1,6-diiodoperfluorohexane",375-80-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93e79a1b-b3b8-42a6-856a-d17549688a17/documents/IUC5-4df95bb3-d51a-48dc-9541-97d35118938e_79958d2a-419a-429d-aa6b-1e86b833f68f.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,4.48 mg/m3,,rat "1,6-Hexandiammonium dihydroxide, N,N'-bis-(2-hydroxypropyl)-N,N,N',N'-tetramethyl",35132-93-5, In a 28-day study with rats according to OECD TG 407 (RL1) a NOAEL of >= 200 mg active ingredient/kg bw (the highest concentration tested) was derived. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e61a81a9-5349-4ac7-8342-8ff86422d103/documents/0e2f6b74-c193-40b3-8463-9011b41db805_cb927a26-05fa-450d-8f17-246702a56bf6.html,,,,,, "1,6-Hexandiammonium dihydroxide, N,N'-bis-(2-hydroxypropyl)-N,N,N',N'-tetramethyl",35132-93-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e61a81a9-5349-4ac7-8342-8ff86422d103/documents/0e2f6b74-c193-40b3-8463-9011b41db805_cb927a26-05fa-450d-8f17-246702a56bf6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "1,6-Hexandiammonium dihydroxide, N,N'-bis-(2-hydroxypropyl)-N,N,N',N'-tetramethyl",35132-93-5," The oral LD50 in rats is between 300 and 2000 mg/kg bw (RL1). The acute inhalation study was waived in accordance with Column 2 of REACH Annex VIII No. 8.5, as acute toxicity studies do not need to be conducted when the substance is classified for skin corrosion (H314). The acute dermal study was waived in accordance with Column 2 of REACH Annex VIII No. 8.5, as acute toxicity studies do not need to be conducted when the substance is classified for skin corrosion (H314). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e61a81a9-5349-4ac7-8342-8ff86422d103/documents/293f2eb3-8347-4ca7-be8b-2bcecbfbf6f0_cb927a26-05fa-450d-8f17-246702a56bf6.html,,,,,, "1,6-Hexandiammonium dihydroxide, N,N'-bis-(2-hydroxypropyl)-N,N,N',N'-tetramethyl",35132-93-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e61a81a9-5349-4ac7-8342-8ff86422d103/documents/293f2eb3-8347-4ca7-be8b-2bcecbfbf6f0_cb927a26-05fa-450d-8f17-246702a56bf6.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, "1,6-Hexanediamine, N1,N1,N6,N6-tetramethyl-, propoxylated (>1 < 4,5 mol PO)",158451-78-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76f765e3-47a2-4f9a-866d-9a159eee13c0/documents/32d88008-ec92-4a53-a4ce-085b998db3e2_4502560e-22b0-4eff-8ad5-0c0b94632427.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,6-Hexanediamine, N1,N1,N6,N6-tetramethyl-, propoxylated (>1 < 4,5 mol PO)",158451-78-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76f765e3-47a2-4f9a-866d-9a159eee13c0/documents/96fd828c-eb1e-4a09-94dd-ffead7b5d29f_4502560e-22b0-4eff-8ad5-0c0b94632427.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3,3-dimethylbutan-2-yl)({6-[(3,3-dimethylbutan-2-yl)amino]hexyl}amine)",957787-76-7,"In a 28-day oral (gavage) study in rats an NOAEL of 5 mg/kg bw/day was established. The main target organs identified were the lungs and adrenals.No mortality, except for one animal in the high dose group, was seen in this study in rats. Treatment related adverse effects were noted in the high and mid dose groups (20 and 10 mg/kg bw/day). The most prominent effects observed were inflammatory changes in the lungs and changes in the adrenals including fascicular hypertrophy, apoptosis and atrophy. These two organs were already affected at the 10 mg/kg/day dose level. At the high dose level additional changes in the kidney, liver and thyroid became apparent that were also accompanied by corresponding changes in clinical chemistry (e.g. increases in ALAT and ASAT, increased white blood cell counts and neutrophiles). Some adaptive changes that were mostly within the physiological range were already observed at the low dose, but are not considered adverse. A NOAEL of 5 mg/kg bw/d was therefore derived from this study. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/789dc265-cbfa-4903-aa1f-218bd8de95a5/documents/IUC5-ce594299-b057-4478-9ffd-1c65bf060935_cffa9ea8-a17a-4df4-9f4b-f7f913f55473.html,,,,,, "3,3-dimethylbutan-2-yl)({6-[(3,3-dimethylbutan-2-yl)amino]hexyl}amine)",957787-76-7,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/789dc265-cbfa-4903-aa1f-218bd8de95a5/documents/IUC5-ce594299-b057-4478-9ffd-1c65bf060935_cffa9ea8-a17a-4df4-9f4b-f7f913f55473.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat "3,3-dimethylbutan-2-yl)({6-[(3,3-dimethylbutan-2-yl)amino]hexyl}amine)",957787-76-7,The substance was harmful ofter single oral administration to rats. Inhalation exposure is unlikely due to the low vapour pressure of the substance. Based on the physical chemical properties dermal absorption is likely less than the uptake by the oral route. Dermal contact has to be minimized due to the skin sensitizing properties of the compound. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/789dc265-cbfa-4903-aa1f-218bd8de95a5/documents/IUC5-151d304c-67e5-4a9f-8972-b59988057a27_cffa9ea8-a17a-4df4-9f4b-f7f913f55473.html,,,,,, "3,3-dimethylbutan-2-yl)({6-[(3,3-dimethylbutan-2-yl)amino]hexyl}amine)",957787-76-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/789dc265-cbfa-4903-aa1f-218bd8de95a5/documents/IUC5-151d304c-67e5-4a9f-8972-b59988057a27_cffa9ea8-a17a-4df4-9f4b-f7f913f55473.html,,oral,LD50,550 mg/kg bw,adverse effect observed, "3,3-dimethylbutan-2-yl)({6-[(3,3-dimethylbutan-2-yl)amino]hexyl}amine)",957787-76-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/789dc265-cbfa-4903-aa1f-218bd8de95a5/documents/IUC5-151d304c-67e5-4a9f-8972-b59988057a27_cffa9ea8-a17a-4df4-9f4b-f7f913f55473.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,6-Bis[2,2-dimethyl-3-(N-morpholino)-propylideneamino]-hexane",1217271-49-2," Based on the results of an OECD 422 compliant study, a NOAEL for systemic effects was determined to be 1000 mg/kg bw/d since no adverse effects were observed. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dd07f5c-457a-4f73-bd14-0da40123a0d4/documents/429ec1fb-33ee-46ff-8123-e69d6641943f_262f2487-10da-495e-89bb-60040abb7f04.html,,,,,, "1,6-Bis[2,2-dimethyl-3-(N-morpholino)-propylideneamino]-hexane",1217271-49-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dd07f5c-457a-4f73-bd14-0da40123a0d4/documents/429ec1fb-33ee-46ff-8123-e69d6641943f_262f2487-10da-495e-89bb-60040abb7f04.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,6-Bis[2,2-dimethyl-3-(N-morpholino)-propylideneamino]-hexane",1217271-49-2, The test item was tested for acute oral toxicity in study with rats according to OECD Guideline 423 (Acute toxic class method). The study revealed an acute oral toxicity greater than 2000 mg/kg bw in rats. The test item was tested for acute dermal toxicity in study with rats according to OECD Guideline 402. The study revealed an acute dermal toxicity greater than 2000 mg/kg bw in female rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dd07f5c-457a-4f73-bd14-0da40123a0d4/documents/78a4f20b-eea6-452c-be3c-e1e2e22e4d4c_262f2487-10da-495e-89bb-60040abb7f04.html,,,,,, "1,6-Bis[2,2-dimethyl-3-(N-morpholino)-propylideneamino]-hexane",1217271-49-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dd07f5c-457a-4f73-bd14-0da40123a0d4/documents/78a4f20b-eea6-452c-be3c-e1e2e22e4d4c_262f2487-10da-495e-89bb-60040abb7f04.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,6-Bis[2,2-dimethyl-3-(N-morpholino)-propylideneamino]-hexane",1217271-49-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dd07f5c-457a-4f73-bd14-0da40123a0d4/documents/78a4f20b-eea6-452c-be3c-e1e2e22e4d4c_262f2487-10da-495e-89bb-60040abb7f04.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,6-hexanediyl-bis(2-(2-(1-ethylpentyl)-3-oxazolidinyl)ethyl)carbamate",140921-24-0,"The results of the 28-Day Repeated Dose Oral Toxicity Study of Incozol EH in rats showed no significant toxicological changes related to administration of test substance up to 200 mg/kg bw/day. Therefore the NOAEL was 200 mg/kg bw/day under the conditions of this study. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP study according to guideline. Reliable without restrictions. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acd974b6-f903-48ed-b4bb-f45ad2d51850/documents/9cce0c3a-2588-487e-9e5f-06fd534388ea_ada813a5-0fb2-46b0-adc6-5b366716175f.html,,,,,, "1,6-hexanediyl-bis(2-(2-(1-ethylpentyl)-3-oxazolidinyl)ethyl)carbamate",140921-24-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acd974b6-f903-48ed-b4bb-f45ad2d51850/documents/9cce0c3a-2588-487e-9e5f-06fd534388ea_ada813a5-0fb2-46b0-adc6-5b366716175f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "1,6-hexanediyl-bis(2-(2-(1-ethylpentyl)-3-oxazolidinyl)ethyl)carbamate",140921-24-0, Acute oral toxicity: The LD50 for male and female rats was greater than 2000 mg/kg bw. Acute dermal toxicity: A LD50 value of > 2000 mg/kg bw was determined for the test substance. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acd974b6-f903-48ed-b4bb-f45ad2d51850/documents/226c12fe-ec0e-4557-8336-70c41e66de48_ada813a5-0fb2-46b0-adc6-5b366716175f.html,,,,,, "1,6-hexanediyl-bis(2-(2-(1-ethylpentyl)-3-oxazolidinyl)ethyl)carbamate",140921-24-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acd974b6-f903-48ed-b4bb-f45ad2d51850/documents/226c12fe-ec0e-4557-8336-70c41e66de48_ada813a5-0fb2-46b0-adc6-5b366716175f.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,6-hexanediyl-bis(2-(2-(1-ethylpentyl)-3-oxazolidinyl)ethyl)carbamate",140921-24-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acd974b6-f903-48ed-b4bb-f45ad2d51850/documents/226c12fe-ec0e-4557-8336-70c41e66de48_ada813a5-0fb2-46b0-adc6-5b366716175f.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,8-bis(phenylthio)anthraquinone",13676-91-0," The NOAEL is considered to be 1000 mg/kg bw/day based on the outcome of a 28-day repeated dose oral toxicity study, ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a61f1de1-5847-4589-a478-b60f57688656/documents/IUC5-9a27ccba-29d7-46ed-896e-332e4e0cd345_546ecfd2-d0ba-4d7d-aabd-32303db9d7bf.html,,,,,, "1,8-bis(phenylthio)anthraquinone",13676-91-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a61f1de1-5847-4589-a478-b60f57688656/documents/IUC5-9a27ccba-29d7-46ed-896e-332e4e0cd345_546ecfd2-d0ba-4d7d-aabd-32303db9d7bf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,8-bis(phenylthio)anthraquinone",13676-91-0,The oral and dermal LD50 values for Solvent Yellow 163 were considered to be >2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a61f1de1-5847-4589-a478-b60f57688656/documents/IUC5-a36d528b-811c-44c2-b52e-0f952c3480d2_546ecfd2-d0ba-4d7d-aabd-32303db9d7bf.html,,,,,, "1,8-bis(phenylthio)anthraquinone",13676-91-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a61f1de1-5847-4589-a478-b60f57688656/documents/IUC5-a36d528b-811c-44c2-b52e-0f952c3480d2_546ecfd2-d0ba-4d7d-aabd-32303db9d7bf.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,8-bis(phenylthio)anthraquinone",13676-91-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a61f1de1-5847-4589-a478-b60f57688656/documents/IUC5-a36d528b-811c-44c2-b52e-0f952c3480d2_546ecfd2-d0ba-4d7d-aabd-32303db9d7bf.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,8-bis[(4-methylphenyl)amino]anthraquinone",82-16-6,"Repeated dose toxicity: oral route: Short-term NOAEL (rats / combined) = 1000 mg/kg bw/day (OECD 422, GLP, K, rel.1)   Key information on Category members: - Reinblau RLW: short-term NOAEL (rats/combined) = 1000 mg/kg bw/day (OECD 407, GLP, K, rel.2) - Solvent Green 28: short-term NOAEL (rats / combined) = 1000 mg/kg bw/day (OECD 422, GLP, K, rel.1) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d43ae8c-d6b1-4b31-a9be-2523cddcb46f/documents/ce9d60b6-06a5-4525-be8e-1036f9318034_d444244a-8c23-4772-a917-85a1ce90bc0d.html,,,,,, "1,8-bis[(4-methylphenyl)amino]anthraquinone",82-16-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d43ae8c-d6b1-4b31-a9be-2523cddcb46f/documents/ce9d60b6-06a5-4525-be8e-1036f9318034_d444244a-8c23-4772-a917-85a1ce90bc0d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,8-bis[(4-methylphenyl)amino]anthraquinone",82-16-6,"Acute oral toxicity: LD50 > 15000 mg/kg bw (discriminating dose) (Eqv. OECD 401, K, rel.2).   Key information on Category members: - Reinblau RLW: Acute dermal toxicity: LD50 > 2000 mg/kg bw (discriminating dose) (OECD 402, K, rel.1)   There are no studies available for acute inhalation toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d43ae8c-d6b1-4b31-a9be-2523cddcb46f/documents/7018c948-5618-423b-a9a4-9c831e08a397_d444244a-8c23-4772-a917-85a1ce90bc0d.html,,,,,, "1,8-bis[(4-methylphenyl)amino]anthraquinone",82-16-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d43ae8c-d6b1-4b31-a9be-2523cddcb46f/documents/7018c948-5618-423b-a9a4-9c831e08a397_d444244a-8c23-4772-a917-85a1ce90bc0d.html,,oral,discriminating dose,"15,000 mg/kg bw",no adverse effect observed, "1,8-bis[(4-methylphenyl)amino]anthraquinone",82-16-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d43ae8c-d6b1-4b31-a9be-2523cddcb46f/documents/7018c948-5618-423b-a9a4-9c831e08a397_d444244a-8c23-4772-a917-85a1ce90bc0d.html,,dermal,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, "1,8-diazabicyclo[5.4.0]undec-7-ene",6674-22-2," In the rat reproduction toxicity study, DBU was administered for 29 days to male rats and for 43 to 57 days to female rats. Doses of 150 mg / kg body weight have caused the appearance of parental toxicity, with macroscopic effects such as dark red stools and irregular stomach surface. Microscopic analysis showed hemorrhage, degeneration of the glandular mucosa, inflammation, hyperplasia, and hyperkeratosis. All effects were local and limited to the stomach, and can be attributed to the strong alkaline corrosiveness of the DBU. No other toxicologically significant change was observed in animals treated with 150 mg / kg body weight of DBU, whereas no adverse effects were found for the remaining dosages. The NOAEL for parental toxicity was then set at 50 mg / kg of body weight. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a388896-2455-47d6-9c65-5b9a79f928c2/documents/80b3c9e1-2021-412a-86db-31193fe2ac28_fd952235-d323-4e44-817e-46444abebb98.html,,,,,, "1,8-diazabicyclo[5.4.0]undec-7-ene",6674-22-2, Acute toxicity (oral): LD50 rat = 215-681 mg/kg (OECD 401) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a388896-2455-47d6-9c65-5b9a79f928c2/documents/b1d2cf17-567e-4f08-abe2-8cc009416d5f_fd952235-d323-4e44-817e-46444abebb98.html,,,,,, "1,8-diazabicyclo[5.4.0]undec-7-ene",6674-22-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a388896-2455-47d6-9c65-5b9a79f928c2/documents/b1d2cf17-567e-4f08-abe2-8cc009416d5f_fd952235-d323-4e44-817e-46444abebb98.html,,oral,LD50,215 mg/kg bw,adverse effect observed, "1,8-dihydroxy-4,5-dinitroanthraquinone",81-55-0, No acute toxicity expected ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/421550dd-b83b-4361-8c6f-2ebb6806319c/documents/82f2a3fb-af86-4229-9634-02bf895a34d0_f8bbc4af-0713-401a-8042-ce0127e5f725.html,,,,,, "1,8-dihydroxy-4-nitro-5-(phenylamino)anthraquinone",20241-76-3, The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was 1000 mg/kg bw/day for either sex. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3607b84-17ef-48c9-a2e1-6a1d68ba668d/documents/7771bc93-badb-412c-9902-34d600045c90_0b3df6b2-793e-4a62-ac56-08ea77e82bc6.html,,,,,, "1,8-dihydroxy-4-nitro-5-(phenylamino)anthraquinone",20241-76-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3607b84-17ef-48c9-a2e1-6a1d68ba668d/documents/7771bc93-badb-412c-9902-34d600045c90_0b3df6b2-793e-4a62-ac56-08ea77e82bc6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,8-dihydroxy-4-nitro-5-(phenylamino)anthraquinone",20241-76-3, The acute oral LD50 in rats was determined to be >10000 mg/kg bw. In total 3 studies with company data and one OECD 423 study conducted by the Japanese METI Institute are available. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3607b84-17ef-48c9-a2e1-6a1d68ba668d/documents/ebfe7c44-99f9-4ce3-a43e-ed8214186792_0b3df6b2-793e-4a62-ac56-08ea77e82bc6.html,,,,,, "1,8-dihydroxy-4-nitro-5-(phenylamino)anthraquinone",20241-76-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3607b84-17ef-48c9-a2e1-6a1d68ba668d/documents/ebfe7c44-99f9-4ce3-a43e-ed8214186792_0b3df6b2-793e-4a62-ac56-08ea77e82bc6.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Naphthalene-1,8-diyl dibenzoate",331711-99-0,"OECD 423 (BASF Corporation, 2014): LD50 oral >2000 mg/kg bw in rats ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48f1faa0-41ac-44a8-b326-e06f0fa7b5cd/documents/IUC5-0b38bc29-2b15-4b83-9e0c-5e924f3830c2_cc209ac0-2c52-45e0-a309-c2c9a9bfa192.html,,,,,, "Naphthalene-1,8-diyl dibenzoate",331711-99-0,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48f1faa0-41ac-44a8-b326-e06f0fa7b5cd/documents/IUC5-0b38bc29-2b15-4b83-9e0c-5e924f3830c2_cc209ac0-2c52-45e0-a309-c2c9a9bfa192.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,8-naphthylenediamine",479-27-6,"Ten male an ten female rats were exposed on 5 consecutive days for 6 hours per day nose/head only to an aerosol of 10, 75 or 394 mg 1,8-naphthylenediamine/m³ under dynamic conditions. The post-exposere time was 3 (intermediate section) or 17 days (endsection).The animals were observed for mortality and clinical signs. In addition, clinical pathology of blood samples was performed. Organs and tissues were subjected to gross and histopathological investigation. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d3367ea-0ac6-4ee1-b496-6a520e6cbe63/documents/5941b2a9-06e6-41e6-935e-99cfafce2378_4d364d20-900d-4712-98ac-c68c52989c48.html,,,,,, "1,8-naphthylenediamine",479-27-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d3367ea-0ac6-4ee1-b496-6a520e6cbe63/documents/5941b2a9-06e6-41e6-935e-99cfafce2378_4d364d20-900d-4712-98ac-c68c52989c48.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,75 mg/kg bw/day,,rat "1,8-naphthylenediamine",479-27-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d3367ea-0ac6-4ee1-b496-6a520e6cbe63/documents/5941b2a9-06e6-41e6-935e-99cfafce2378_4d364d20-900d-4712-98ac-c68c52989c48.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,75 mg/m3,,rat "1,8-naphthylenediamine",479-27-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d3367ea-0ac6-4ee1-b496-6a520e6cbe63/documents/5941b2a9-06e6-41e6-935e-99cfafce2378_4d364d20-900d-4712-98ac-c68c52989c48.html,Repeated dose toxicity – local effects,inhalation,NOAEC,394 mg/m3,no adverse effect observed,rat "1,8-naphthylenediamine",479-27-6,"Valid studies for acute oral, dermal and inhalation toxicity are available ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d3367ea-0ac6-4ee1-b496-6a520e6cbe63/documents/0d24a057-33a3-4b46-861f-3a36cee6ec15_4d364d20-900d-4712-98ac-c68c52989c48.html,,,,,, "1,8-naphthylenediamine",479-27-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d3367ea-0ac6-4ee1-b496-6a520e6cbe63/documents/0d24a057-33a3-4b46-861f-3a36cee6ec15_4d364d20-900d-4712-98ac-c68c52989c48.html,,oral,LD50,591 mg/kg bw,adverse effect observed, "1,8-naphthylenediamine",479-27-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d3367ea-0ac6-4ee1-b496-6a520e6cbe63/documents/0d24a057-33a3-4b46-861f-3a36cee6ec15_4d364d20-900d-4712-98ac-c68c52989c48.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,8-naphthylenediamine",479-27-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d3367ea-0ac6-4ee1-b496-6a520e6cbe63/documents/0d24a057-33a3-4b46-861f-3a36cee6ec15_4d364d20-900d-4712-98ac-c68c52989c48.html,,inhalation,discriminating conc.,877 mg/m3,no adverse effect observed, "1-[([[(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl]oxy]carbonyl)oxy]pyrrolidine-2,5-dione",253265-97-3," Repeated dose toxicity - oral: In a combined 28-day repeated dose toxicity study with the reproduction/ developmental toxicity screening test, the test substance was administered daily to rats up to a dose level of 0, 11, 33 and 90 mg/kg body weight/day (OECD 422; Peter B., 2017). The NOAEL is established to be 33 mg/kg bodyweight. Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07740dd2-d9d4-41fb-8678-37c2d77e3b82/documents/24a7f32b-0ef5-42ee-a15d-eb59314f3d31_b5b00718-1c08-4a22-863c-9b41f82947f7.html,,,,,, "1-[([[(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl]oxy]carbonyl)oxy]pyrrolidine-2,5-dione",253265-97-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07740dd2-d9d4-41fb-8678-37c2d77e3b82/documents/24a7f32b-0ef5-42ee-a15d-eb59314f3d31_b5b00718-1c08-4a22-863c-9b41f82947f7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,33 mg/kg bw/day,,rat "1-[([[(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl]oxy]carbonyl)oxy]pyrrolidine-2,5-dione",253265-97-3," Acute oral toxicity: In an acute oral toxicity study in HanRcc: Wist(SPF) rats, following the acute toxic class method in accordance with the OECD guideline n° 423 and EU Method B.1 tris, the LD50 was determined to be 1000 mg/kg bw for female animals. The study has been performed in compliance with GLP (Van Sas P, 2017). Acute inhalation toxicity: No study is available. This endpoint is waived based on the following justification. A key study is available for the oral and dermal route of exposure. According to the REACH regulation, for substances other than gasses, only one additional route of exposure should be tested other than the oral route of exposure for acute toxicity (column 2, Annex VIII, section 8.5). Therefore, it is not necessary to perform an acute toxicity test via inhalation. Acute dermal toxicity In an acute dermal toxicity study in female wistar rats performed acording to the OECD guideline 402, the LD50 was established to exceed 2000 mg/kg bw (Van Sas P, 2019) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07740dd2-d9d4-41fb-8678-37c2d77e3b82/documents/a852589c-9be0-47fa-9d81-399c76e75e00_b5b00718-1c08-4a22-863c-9b41f82947f7.html,,,,,, "1-[([[(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl]oxy]carbonyl)oxy]pyrrolidine-2,5-dione",253265-97-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07740dd2-d9d4-41fb-8678-37c2d77e3b82/documents/a852589c-9be0-47fa-9d81-399c76e75e00_b5b00718-1c08-4a22-863c-9b41f82947f7.html,,oral,LD50,"1,000 mg/kg bw",no adverse effect observed, "1-[([[(3R,3aS,6aR)-hexahydrofuro[2,3-b]furan-3-yl]oxy]carbonyl)oxy]pyrrolidine-2,5-dione",253265-97-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07740dd2-d9d4-41fb-8678-37c2d77e3b82/documents/a852589c-9be0-47fa-9d81-399c76e75e00_b5b00718-1c08-4a22-863c-9b41f82947f7.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "1-[(2-fluorophenyl)methyl]pyrazolo[3,4-b]pyridine-3-carbonitrile",256376-65-5,"No experimental data on acute toxicity of the test item is available. An in silico and read-across prediction for acute oral toxicity was conducted on March 19, 2024 using four different tools (DEREK, Leadscope, EPA TEST, OECD TB). The test item was predicted to have an acute oral toxicity and shall be classified with Cat. 3. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91f482bf-e4ca-4a33-9475-46aeebca021c/documents/c809a514-9bf4-43e1-addd-dd4eb002c49f_96ac1314-f0d8-4820-ad2a-221754e033e7.html,,,,,, 1-[(2-hydroxyethyl)thio]propan-2-ol,6713-03-7," The short-term repeated dose toxicity of 1-[(2-hydroxyethyl)thio]propan-2-ol via the oral route was investigated during a study performed using a method similar to OECD Test Guideline 407 (GLP) with deviations. The test substance was administered orally at doses of 20, 140 and 1000 mg/kg bw/day to Sprague-Dawley rats. Pure water was used as a vehicle and this was also used in the control group. Recovery animals were included for the control and highest dose, and observed for 14 days after the end of the treatment. Animals were observed daily for clinical signs. Body weights were recorded on the first day of the treatment then weekly. Haematology and clinical chemistry were investigated, and urinalysis performed. At the end of the treatment or of the recovery period, animals were sacrificed, and a gross pathology and histopathology performed. All the rats survived to the end of the studies. No clinical signs or effects on body weight were observed in any of the rats. Changes were detected in the haematology and clinical chemistry parameters, and during the urinalysis, organ weighting, and histopathology, but they were not considered as significant and treatment-related. It is concluded that no significant signs of toxicity were observed. The NOAEL was determined to be 1,000 mg/kg bw/day as it was the highest dose evaluated. In accordance with Annex VIII of REACH, Column 2, testing by the inhalation and dermal routes is only appropriate if exposure of humans via these routes is likely. 1-[(2-hydroxyethyl)thio]propan-2-ol is not made available on the EU market as a monomer and is imported already polymerised. Therefore no exposure of humans via the dermal and inhalation routes is expected. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1910a1c-5836-4b51-9c08-114e062f12c6/documents/8ea40fb5-8ba8-4e2b-a959-d8a1e742d0be_3e6498f3-6c29-460c-b742-8db35577ef56.html,,,,,, 1-[(2-hydroxyethyl)thio]propan-2-ol,6713-03-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1910a1c-5836-4b51-9c08-114e062f12c6/documents/8ea40fb5-8ba8-4e2b-a959-d8a1e742d0be_3e6498f3-6c29-460c-b742-8db35577ef56.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 1-[(2-hydroxyethyl)thio]propan-2-ol,6713-03-7," An assessment was performed based on the outcome of a short-term repeated-dose toxicity study performed on the substance via the oral route to determine the acute oral toxicity of the registered substance. As a conclusion 1-[(2-hydroxyethyl)thio]propan-2-ol is expected to have a low acute oral toxicity with an LD50 > 2000 mg/kg. In accordance with Annex VIII of REACH, Column 2, testing by the inhalation and dermal routes is only appropriate if exposure of humans via these routes is likely. 1-[(2-hydroxyethyl)thio]propan-2-ol is not made available on the EU market as a monomer and is imported already polymerised. Therefore no exposure of humans via the dermal and inhalation routes is expected. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1910a1c-5836-4b51-9c08-114e062f12c6/documents/34a6a108-3255-48a4-913f-8284baae2125_3e6498f3-6c29-460c-b742-8db35577ef56.html,,,,,, 1-[(2-hydroxyethyl)thio]propan-2-ol,6713-03-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1910a1c-5836-4b51-9c08-114e062f12c6/documents/34a6a108-3255-48a4-913f-8284baae2125_3e6498f3-6c29-460c-b742-8db35577ef56.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-[(3,4-dimethoxyphenyl)methyl]-3,4-dihydro-6,7-dimethoxyisoquinoline",6957-27-3, Dihydropapaverine is an intermediate of Papaverine; the molecular formula is very similar; the data below is refered to Papaverine (CAS 58 -74 -2). This data is used in read-across. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ba281a0-cd8f-4c5d-9472-c8514546c654/documents/8ba222d9-ab9b-4584-8aef-a9bcf3d828b5_28e70506-e23f-4d6c-b740-c480a3a11e78.html,,,,,, "1-[(3,4-dimethoxyphenyl)methyl]-3,4-dihydro-6,7-dimethoxyisoquinoline",6957-27-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ba281a0-cd8f-4c5d-9472-c8514546c654/documents/8ba222d9-ab9b-4584-8aef-a9bcf3d828b5_28e70506-e23f-4d6c-b740-c480a3a11e78.html,,oral,LD50,325 mg/kg bw,adverse effect observed, 1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea,66063-05-6,"Studies of repeated dose oral toxicity for pencycuron are available in the rat (90-day, 2-year), mouse (90-day, 2-year) and dog (12-month).  A 21-day repeated dose dermal toxicity in the rabbit is also available. Test Species/Type Results Assessment Reference None - 4-week dietary toxicity study in the rat (100, 1000, 10000 ppm) with 4-week and 9-week recovery periods A NOAEL could not be determined for this study due to methodological deficiencies Not specified. Inukai et al (1978) None - 4-week dietary toxicity study in the mouse (100, 1000, 10000 ppm) with 4-week and 9-week recovery periods A NOAEL could not be determined for this study due to methodological deficiencies Not specified. Inukai et al (1978) None - 21-day dermal study in rabbits (50, 250 mg/kg bw/d) A NOAEL could not be determined for this study due to methodological deficiencies Not specified. Flucke and Gröning (1981) OECD 410 - 21-day dermal study in rabbits (250, 500, 1000 mg/kg bw/d) with a 14-day recovery A NOAEL of 1000 mg/kg bw/d was determined for this study in the absence of any clear effects at the high dose level Supporting study Diesing (1992) None - [Formulation study] 21-day inhalation toxicitiy study in the rat (0.022, 0.088, 0.446 mg/L) A NOAEC could not be determined for this study; effects were attributed to product co-formulants. Not specified.  The product study is not relevant for active substance risk assessment. Thyssen and Mohr (1981) None, pre-dates OECD 408 but broadly comparable - 13-week dietary toxicity study in the rat (80, 400, 2000, 10000 ppm) A NOAEL of 2000 ppm (120 mg/kg bw/d was determined for this study, based on liver findings at 10000 ppm. Supporting study Inukai et al (1978) None, pre-dates OECD 408 but broadly comparable - 13-week dietary toxicity study in the mouse (80, 400, 2000, 10000 ppm) A NOAEL of 400 ppm (65 mg/kg bw/d was determined for this study, based on liver findings in females at 2000 ppm and in both sexes at 10000 ppm. Key study Inukai et al (1978) OECD 409 - 12-month chronic toxicity study in the dog (100, 1000, 10000 ppm) A NOAEL of 10000 ppm (277 mg/kg bw/d) was determined for this study in the absence of any effects of treatment at the top dose level Supporting study Bathe et al (1983) OECD 453 - Combined chronic dietary toxicity/ carcinogenicity study in the rat (50, 500, 5000 ppm) A NOAEL of 500 ppm (18 mg/kg bw/d) was determined for this study, based on liver and lung effects.  There was no evidence of carcinogenicity. Supporting study Shirasu et al (1981) Non-guideline - Position paper considering liver histopathology in the rat chronic tox/carc study The paper concludes that there is no liver carcinogenicity in the rat study, and supports an overall NOAEL of 500 ppm for liver effects - concludes that there is no liver carcimogenicity Rinke (2005) OECD 453 - Combined chronic dietary toxicity/ carcinogenicity study in the mouse (50, 500, 5000 ppm) A NOAEL of 500 ppm (43 mg/kg bw/d) was determined for this study, based on liver in males.  There was no evidence of carcinogenicity. Supporting study Shirasu et al (1981) OECD 424 - Sub-chronic neurotoxicity study in the rat (500, 2500, 15000 ppm) The NOAEL for this study was 2500 ppm (181/275 mg/kg bw/d) based on increased marginally increased motor and locomotor activities at 15000 ppm.  Gait abnormalities were seen in all treated groups but were not considered adverse. Supporting study Schladt and Lawrence (2006) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): A guideline-compliant study is available Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): A guideline-compliant study is available Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Studies are guideline-compliant or guideline-comparable (Klimisch score 1 or 2) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ab3bb4e-ce4c-48e9-8529-e5ff528db7cb/documents/aaed19af-8292-4e65-916c-797c978b0b59_ffc26e57-a74b-4547-945f-89718b6867d3.html,,,,,, 1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea,66063-05-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ab3bb4e-ce4c-48e9-8529-e5ff528db7cb/documents/aaed19af-8292-4e65-916c-797c978b0b59_ffc26e57-a74b-4547-945f-89718b6867d3.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rabbit 1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea,66063-05-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ab3bb4e-ce4c-48e9-8529-e5ff528db7cb/documents/aaed19af-8292-4e65-916c-797c978b0b59_ffc26e57-a74b-4547-945f-89718b6867d3.html,Chronic toxicity – systemic effects,oral,NOAEL,18 mg/kg bw/day,,rat 1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea,66063-05-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ab3bb4e-ce4c-48e9-8529-e5ff528db7cb/documents/aaed19af-8292-4e65-916c-797c978b0b59_ffc26e57-a74b-4547-945f-89718b6867d3.html,Repeated dose toxicity – local effects,dermal,NOAEL,"1,000 ",,rabbit 1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea,66063-05-6,"GLP- and guideline-compliant studies of acute oral, inhalation and dermal toxicity are available for pencycuron. Test Species/Type Results Assessment Reference OECD 401 - Acute oral toxicity in the rat The acute oral LD50 of pencycuron was found to be >5000 mg/kg bw under the conditions of this study.  Classification not required. Key study Sheets (1989) None - Acute oral toxicity in the rat (single dose level of 1000 mg/kg bw) The acute oral LD50 of pencycuron was found to be >1000 mg/kg bw under the conditions of this study. - not considered acceptable Ono and Iyatomi (1978) None - Acute oral toxicity in the mouse The acute oral LD50 of pencycuron was found to be >5000 mg/kg bw under the conditions of this study. - not considered acceptable Kawaguchi et al (1979) OECD 403 - Acute inhalation study in the rat: head/nose exposure. MMAD 5.61 um The acute inhalation LC50 of pencycuron was found to be >5.13 mg/L under the conditions of this study.  Classification not required. Key study Pauluhn (1990) OECD 402 - Acute dermal toxicity study in the rat (occlusive, 24-h) The acute dermal LD50 of pencycuron was found to be >2000 mg/kg bw under the conditions of this study.  Classification not required. Key study Sheets (1988) None - Acute dermal toxicity in the rat The acute dermal LD50 of pencycuron was found to be >2000 mg/kg bw under the conditions of this study. - not considered acceptable due to deficiencies Ono and Iyatomi (1978) None - Acute dermal toxicity in the mouse The acute dermal LD50 of pencycuron was found to be >2000 mg/kg bw under the conditions of this study. - not considered acceptable due to deficiencies Kawaguchi et al (1978)  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): A GLP- and guideline-compliant study of acute oral toxicity in the rat is available for pencycuron Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): A GLP- and guideline-compliant study of acute inhalation toxicity is available for pencycuron Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): A GLP- and guideline-compliant study of acute dermal toxicity in the rabbit is available for pencycuron ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ab3bb4e-ce4c-48e9-8529-e5ff528db7cb/documents/636bccab-62d4-4a7b-bb6d-8346ae04ca91_ffc26e57-a74b-4547-945f-89718b6867d3.html,,,,,, 1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea,66063-05-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ab3bb4e-ce4c-48e9-8529-e5ff528db7cb/documents/636bccab-62d4-4a7b-bb6d-8346ae04ca91_ffc26e57-a74b-4547-945f-89718b6867d3.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, 1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea,66063-05-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ab3bb4e-ce4c-48e9-8529-e5ff528db7cb/documents/636bccab-62d4-4a7b-bb6d-8346ae04ca91_ffc26e57-a74b-4547-945f-89718b6867d3.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 1-[(4-chlorophenyl)methyl]-1-cyclopentyl-3-phenylurea,66063-05-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ab3bb4e-ce4c-48e9-8529-e5ff528db7cb/documents/636bccab-62d4-4a7b-bb6d-8346ae04ca91_ffc26e57-a74b-4547-945f-89718b6867d3.html,,inhalation,LC50,> 5.13 mg/L,no adverse effect observed, 1-[(4-chlorophenyl)sulfanyl]propan-2-one,25784-83-2, Acute oral toxicity: Key study: Test method according OECD Guideline 420. GLP study. The oral-LD50 for the test substance in female rats was determined to be higher than 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b97a4ef-390f-4fd5-937c-34af76d4f97d/documents/a0eee4ee-9e1e-4819-95a2-6b3e6653781f_29677b21-8b78-4d8b-8c4b-e7dacf52348e.html,,,,,, 1-[(4-chlorophenyl)sulfanyl]propan-2-one,25784-83-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b97a4ef-390f-4fd5-937c-34af76d4f97d/documents/a0eee4ee-9e1e-4819-95a2-6b3e6653781f_29677b21-8b78-4d8b-8c4b-e7dacf52348e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-[(7S)-4,7-dihydro-5H-thieno[2,3-c]pyran-7-yl]-N-methylmethanamine (2R)",2374784-46-8," No data on intermediate 1-[(7S)-4,7-dihydro-5H-thieno[2,3-c]pyran-7-yl]-N-methylmethanamine (2R). The available information is for the free base. Oral-dose studies in mice, rats, and dogs over durations of 28 days, 6 and 9 months, respectively are available. In mice, the substance (≤100 mg/kg/day) was generally well tolerated except for limited mortality in females. In rats and dogs, there were clinical observations consistent with CNS activity including dilated pupils (dogs only), increased or decreased activity, impaired coordination, hypersensitivity to touch, salivation, vocalization, lacrimation, and tremor. Convulsions were sporadically noted at >60 mg/kg/day in rats and at 15 mg/kg/day as single instance of self-limiting intermittent convulsions in a female dog. In rats, low body weight gains were noted throughout the dosing period. In dogs, an increased incidence and severity of clinical observations consistent with CNS activity occurred at ≥2.5 mg/kg/day. The NOAELs were 100 and 50 mg/kg/day in male and female mice, 15 mg/kg/day in rats, and 10 mg/kg/day in dogs. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64e62362-d11b-417e-8d69-c744d7e50112/documents/7d4535f8-d31a-4ffc-955d-7376629ac385_6a5d6ce8-12d9-4dd8-97e1-484fc1350f4a.html,,,,,, "1-[(7S)-4,7-dihydro-5H-thieno[2,3-c]pyran-7-yl]-N-methylmethanamine (2R)",2374784-46-8," No data on intermediate 1-[(7S)-4,7-dihydro-5H-thieno[2,3-c]pyran-7-yl]-N-methylmethanamine (2R). The available information is for the free base. In rats, single oral dose (≥100 mg/kg) caused increased vocalization and urination, and reduced grooming. In addition, impaired coordination, splayed limbs, vocalization, salivation, bristling of hairs, decreased activity, tremors, and death were reported at 600 mg/kg. In mice, 100 mg/kg was the maximum tolerated dose and a single dose of ≥150 mg/kg was lethal. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64e62362-d11b-417e-8d69-c744d7e50112/documents/31256851-1d7f-4ffd-9ee7-77f747b40fa7_6a5d6ce8-12d9-4dd8-97e1-484fc1350f4a.html,,,,,, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-N-tridecylnaphthalen-2-amine,57712-94-4," Read Across approach used to analogue substance. Assumption that target substance will have the same properties. Available data for the source subtance Solvent Red 19E: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, oral (gavage), rat (Wistar Han) M/F, OECD guideline 422, GLP: NOAEL <160 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd02333c-fa69-4be0-bd59-c2e15df4d2fe/documents/5c2eed0e-5656-4f87-aaef-037e9fa9bf6c_1cb0c6d0-c830-4ef0-872f-2a8028f50c55.html,,,,,, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-N-tridecylnaphthalen-2-amine,57712-94-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd02333c-fa69-4be0-bd59-c2e15df4d2fe/documents/5c2eed0e-5656-4f87-aaef-037e9fa9bf6c_1cb0c6d0-c830-4ef0-872f-2a8028f50c55.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,160 mg/kg bw/day,,rat 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-N-tridecylnaphthalen-2-amine,57712-94-4," Acute oral toxicity: LD50 > 2000 mg/kg bw, EU Method B.1 tris, OECD 423, GLP compliant Read across to an analogue substance for Acute dermal toxicity: LD50 > 2000 mg/kg bw, EU Method B.3, OECD 402, GLP compliant ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd02333c-fa69-4be0-bd59-c2e15df4d2fe/documents/3f88a342-ed5e-449e-a4cf-450e33585ce2_1cb0c6d0-c830-4ef0-872f-2a8028f50c55.html,,,,,, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-N-tridecylnaphthalen-2-amine,57712-94-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd02333c-fa69-4be0-bd59-c2e15df4d2fe/documents/3f88a342-ed5e-449e-a4cf-450e33585ce2_1cb0c6d0-c830-4ef0-872f-2a8028f50c55.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-N-tridecylnaphthalen-2-amine,57712-94-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd02333c-fa69-4be0-bd59-c2e15df4d2fe/documents/3f88a342-ed5e-449e-a4cf-450e33585ce2_1cb0c6d0-c830-4ef0-872f-2a8028f50c55.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Triasulfuron,82097-50-5,"- Oral: NOAEL = 14 and 18 mg/kg bw/day for males and females, respectively, rats, sub-chronic, 90 days, dietary, Robertson 2013            NOAEL = 33 and 34 mg/kg bw/day, for males and females, respectively, dog, 1 year, dietary, Varney 1986 - Dermal: NOAEL > 1000 mg/kg bw/day for males and female, rabbits, sub-acute, 28 days, occlusive dressing, Robertson 2013 Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): GLP compliant OECD TG 410 study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP compliant OECD TG 408 study ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8bc0aad-6803-4cbf-9220-d165ba57da6f/documents/ce99edbd-9677-4ddd-9ac7-b795d3477e82_771b61f5-6562-4f98-945f-7f5bfe3fbdfa.html,,,,,, Triasulfuron,82097-50-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8bc0aad-6803-4cbf-9220-d165ba57da6f/documents/ce99edbd-9677-4ddd-9ac7-b795d3477e82_771b61f5-6562-4f98-945f-7f5bfe3fbdfa.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,14 mg/kg bw/day,,rat Triasulfuron,82097-50-5,"-Oral: LD50> 5000 mg/kg bw, females, rats, according to OECD TG 425, Petus 2014 -Inhalation: LC50 > 5.22 mg/L , male and females, rats, according to OECD TG 403, Durando 2018 -Dermal: LD50 > 2000 mg/kg bw, males and females, rats, according to OECD TG 402, Petus 2013 Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP compliant OECD TG 425 study. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): GLP compliant OECD TG 402 study. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): GLP compliant OECD TG 403 study. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8bc0aad-6803-4cbf-9220-d165ba57da6f/documents/de81438c-37e5-4b56-b709-579e725b5e68_771b61f5-6562-4f98-945f-7f5bfe3fbdfa.html,,,,,, Triasulfuron,82097-50-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8bc0aad-6803-4cbf-9220-d165ba57da6f/documents/de81438c-37e5-4b56-b709-579e725b5e68_771b61f5-6562-4f98-945f-7f5bfe3fbdfa.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Triasulfuron,82097-50-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8bc0aad-6803-4cbf-9220-d165ba57da6f/documents/de81438c-37e5-4b56-b709-579e725b5e68_771b61f5-6562-4f98-945f-7f5bfe3fbdfa.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Triasulfuron,82097-50-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8bc0aad-6803-4cbf-9220-d165ba57da6f/documents/de81438c-37e5-4b56-b709-579e725b5e68_771b61f5-6562-4f98-945f-7f5bfe3fbdfa.html,,inhalation,LC50,5.22 mg/L,no adverse effect observed, "1-[2-(allyloxy)ethyl-2-(2,4-dichlorophenyl)-1H-imidazolium hydrogen sulphate",58594-72-2,"Repeated dose toxicity - oral: Data generated with the related substance imazalil base is used for endpoint coverage in a read-across approach. In a key sub-chronic toxicity study in rats, the NOAEL of imazalil base is determined to be 200 ppm via diet administration during 1 or 3 months of dosing, corresponding to 15.8 and 18.7 mg/kg body weight/day in males and females, respectively (K2; Van Deun, 1996). The same is assumed to be valid for the test substance. Two supporting studies with the related substance imazalil base are available: a subchronic toxicity study via dietary administration in mice and a chronic toxicity study in rats (dosing period of 26 weeks).Repeated dose toxicity - inhalation: A key study is available for the oral and dermal routes of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure.Repeated dose toxicity - dermal: Data generated with the related substance imazalil base is used for endpoint coverage in a read-across approach. A key K1 study in male and female New Zealand White rabbits in a repeated dose dermal toxicity study was conducted similar to OECD 410 (K1; Teuns, 1991). The related substance imazalil base when administered dermally for three weeks to rabbits at doses 10, 40, and 160 mg/kg body weight/day was well tolerated. The NOAEL is this study can be established at at least 160 mg/kg bw/day. The same is assumed valid for the test substance. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/afd51bc7-02b4-4323-a57f-1f297e84191e/documents/940eea9d-eb07-4c0f-a7eb-f2955c5b4bfe_7d58202b-ea48-4ea6-8833-ef31581ca577.html,,,,,, "1-[2-(allyloxy)ethyl-2-(2,4-dichlorophenyl)-1H-imidazolium hydrogen sulphate",58594-72-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/afd51bc7-02b4-4323-a57f-1f297e84191e/documents/940eea9d-eb07-4c0f-a7eb-f2955c5b4bfe_7d58202b-ea48-4ea6-8833-ef31581ca577.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,160 mg/kg bw/day,,rabbit "1-[2-(allyloxy)ethyl-2-(2,4-dichlorophenyl)-1H-imidazolium hydrogen sulphate",58594-72-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/afd51bc7-02b4-4323-a57f-1f297e84191e/documents/940eea9d-eb07-4c0f-a7eb-f2955c5b4bfe_7d58202b-ea48-4ea6-8833-ef31581ca577.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15.8 mg/kg bw/day,,rat "1-[2-(allyloxy)ethyl-2-(2,4-dichlorophenyl)-1H-imidazolium hydrogen sulphate",58594-72-2," Acute toxicity: Oral: In an acute oral toxicity study in female Sprague-Dawley rats, following the acute toxicity Up-and-Down method in accordance with the OECD Guideline 425 and EPA OPPTS 870.1100, the LD50 was estimated to be 550 mg/kg body weight (Merrill, 2013).  Acute toxicity: Inhalation: In an acute inhalation toxicity study in male and female Sprague-Dawley rats, following the Acute Inhalation Toxicity method in accordance with OECD Guidelines 403, Proposal for Updating Guideline 403 and EPA OPPTS 870.1300, the LC50 (inhalative), four hour exposure of test item for male and female rats is therefore >0.66 mg/l (Weniger, 2000).    Acute toxicity: Dermal: In an acute dermal toxicity limit test in male and female New Zealand albino rabbits, following the Product Safety Labs Protocol P322, Acute Dermal Toxicity Limit Test, the LD50 of the test item was determined to be greater than 2000 mg/kg of bodyweight (Moore, 1998). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/afd51bc7-02b4-4323-a57f-1f297e84191e/documents/7b1b1f62-02e7-4dc7-8fd0-de39fa8b51ea_7d58202b-ea48-4ea6-8833-ef31581ca577.html,,,,,, "1-[2-(allyloxy)ethyl-2-(2,4-dichlorophenyl)-1H-imidazolium hydrogen sulphate",58594-72-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/afd51bc7-02b4-4323-a57f-1f297e84191e/documents/7b1b1f62-02e7-4dc7-8fd0-de39fa8b51ea_7d58202b-ea48-4ea6-8833-ef31581ca577.html,,oral,LD50,550 mg/kg bw,adverse effect observed, "1-[2-(allyloxy)ethyl-2-(2,4-dichlorophenyl)-1H-imidazolium hydrogen sulphate",58594-72-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/afd51bc7-02b4-4323-a57f-1f297e84191e/documents/7b1b1f62-02e7-4dc7-8fd0-de39fa8b51ea_7d58202b-ea48-4ea6-8833-ef31581ca577.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "1-[2-(allyloxy)ethyl-2-(2,4-dichlorophenyl)-1H-imidazolium hydrogen sulphate",58594-72-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/afd51bc7-02b4-4323-a57f-1f297e84191e/documents/7b1b1f62-02e7-4dc7-8fd0-de39fa8b51ea_7d58202b-ea48-4ea6-8833-ef31581ca577.html,,inhalation,LC50,655 mg/m3,adverse effect observed, 1-[2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl]pyridinium acetate,59709-10-3,LD50(male/female) = 2122 mg/kg bw     ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c9bce1c-884f-45ec-b657-5f76013d3a63/documents/65633acd-858a-41b7-a32f-db34bc5e3b02_17f69424-2725-4f98-a61b-fc117b1487af.html,,,,,, 1-[2-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]ethyl]pyridinium acetate,59709-10-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c9bce1c-884f-45ec-b657-5f76013d3a63/documents/65633acd-858a-41b7-a32f-db34bc5e3b02_17f69424-2725-4f98-a61b-fc117b1487af.html,,oral,LD50,"2,122 mg/kg bw",no adverse effect observed, 1-[2-chloro-4-(4-chlorophenoxy)phenyl]ethanone,119851-28-4,"Concerning the acute toxicity (oral) of the test item two studies were performed. Both studies (Klimish 1) comply with the OECD Principles of Good Laboratory Practice (GLP)  Hartmann, 1988 The determination of the acute toxicity (oral) was done according to OECD Guideline 401 (Acute oral toxicity). The test item was administered to rats of both sexes by oral gavage, at a single dose of 2000 mg/kg. No mortality was observed.  The acute oral toxicity of the test item in rats of both sexes, observed over a period of 14 days was determined to be > 2000 mg/kg. Hoff et. al., 1991 The determination of the acute toxicity (oral) was done according to OECD Guideline 401 (Acute oral toxicity) and EU Method B. 1 (Acute toxicity (oral)). The test item was administered to rats of both sexes by oral gavage, at a single dose of 2000 mg/kg. The following death rate was obsereved: 0% at 2000mg/kg. The acute oral toxicity of the test item in rats of both sexes, observed over a period of 15 days was estimated to be > 2000 mg/kg.     Concerning the acute toxicity (dermal ) of the test item two studies were performed. Both studies (Klimish 1) comply with the OECD Principles of Good Laboratory Practice (GLP)  Hartmann, 1988 The determination of the acute toxicity (dermal) was done according to OECD Guideline 402 (Acute dermal toxicity). Upon an acute dermal application and a 14 day post-treatment observation period the LD50 of the test item of both sexes was determined to be >2000 mg/kg bw. Ullmann et al., 1991 The determination of the acute toxicity (dermal) was done according to OECD Guideline 402 (Acute dermal toxicity). The test item was applied to the skin of rats of both sexes for 24 hours at a single dose of 2000 mg/kg/bw. The following death rate was observed: 0% at 2000 mg/kg/bw. Therefore the toxicity of the test item was estimeted to be greater than 2000 mg/kg/bw. Concerning the acute toxicity (inhalation) of the test item a study was performed. The study (Klimish 1) comply with the OECD Principles of Good Laboratory Practice (GLP)  Hartmann, 1988 The study was carried out in accordance with the OECD Guideline 403 ((Acute inhalation toxicity). The acute aerosol inhalation toxicity of the TS was determined to be: LC50 (m/f) >5100 mg/m3 air. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be53fe70-ca50-4a29-9579-ec8fa90e4033/documents/IUC5-acffcf43-71d4-4926-af04-dd5050c77f86_d29d1708-fd8c-49ee-a5bc-9c83bbf388ca.html,,,,,, 1-[2-chloro-4-(4-chlorophenoxy)phenyl]ethanone,119851-28-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be53fe70-ca50-4a29-9579-ec8fa90e4033/documents/IUC5-acffcf43-71d4-4926-af04-dd5050c77f86_d29d1708-fd8c-49ee-a5bc-9c83bbf388ca.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 1-[2-chloro-4-(4-chlorophenoxy)phenyl]ethanone,119851-28-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be53fe70-ca50-4a29-9579-ec8fa90e4033/documents/IUC5-acffcf43-71d4-4926-af04-dd5050c77f86_d29d1708-fd8c-49ee-a5bc-9c83bbf388ca.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 1-[2-chloro-4-(4-chlorophenoxy)phenyl]ethanone,119851-28-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be53fe70-ca50-4a29-9579-ec8fa90e4033/documents/IUC5-acffcf43-71d4-4926-af04-dd5050c77f86_d29d1708-fd8c-49ee-a5bc-9c83bbf388ca.html,,inhalation,LC50,"> 5,100 mg/m3",no adverse effect observed, "1-[2-fluoro-6-(trifluoromethyl)benzyl]-5-iodo-6-methylpyrimidine-2,4(1H,3H)-dione",1150560-54-5," The results from the acute oral, acute inhalation, and acute dermal toxicity studies indicated that there was no indication of toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a3020f5-a1b1-4658-8294-87e922da8c2c/documents/4e93c24f-49e9-4668-92e0-ad1ded4c999e_47622b9c-743a-4205-b598-2ed694754fec.html,,,,,, "1-[2-fluoro-6-(trifluoromethyl)benzyl]-5-iodo-6-methylpyrimidine-2,4(1H,3H)-dione",1150560-54-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a3020f5-a1b1-4658-8294-87e922da8c2c/documents/4e93c24f-49e9-4668-92e0-ad1ded4c999e_47622b9c-743a-4205-b598-2ed694754fec.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-[2-fluoro-6-(trifluoromethyl)benzyl]-5-iodo-6-methylpyrimidine-2,4(1H,3H)-dione",1150560-54-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a3020f5-a1b1-4658-8294-87e922da8c2c/documents/4e93c24f-49e9-4668-92e0-ad1ded4c999e_47622b9c-743a-4205-b598-2ed694754fec.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-[2-fluoro-6-(trifluoromethyl)benzyl]-5-iodo-6-methylpyrimidine-2,4(1H,3H)-dione",1150560-54-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a3020f5-a1b1-4658-8294-87e922da8c2c/documents/4e93c24f-49e9-4668-92e0-ad1ded4c999e_47622b9c-743a-4205-b598-2ed694754fec.html,,inhalation,LC50,"5,035 mg/m3",no adverse effect observed, 1-[bis[3-(dimethylamino)propyl]amino]propan-2-ol,67151-63-7," Repeated dose toxicity - oral: A GLP compliant 90-day repeated dose toxicity study according to OECD guideline 408 was performed in rats via oral gavage. Dose levels tested were 10, 25 and 75 mg/kg. The NOEL for females was considered to be 25 mg/kg bw/day and 10 mg/kg bw/day for males. Repeated dose toxicity - dermal/inhalation: No reliable data were available for these exposure routes. Therefore, no NOAEL for these routes of administration was established. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7124f4f4-98eb-4ded-9348-8b9b3ba52d00/documents/e24e79e9-3001-44af-8730-5f5e904e9ff7_b8a783a6-d146-4039-9f0a-bbedf9002222.html,,,,,, 1-[bis[3-(dimethylamino)propyl]amino]propan-2-ol,67151-63-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7124f4f4-98eb-4ded-9348-8b9b3ba52d00/documents/e24e79e9-3001-44af-8730-5f5e904e9ff7_b8a783a6-d146-4039-9f0a-bbedf9002222.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat 1-[bis[3-(dimethylamino)propyl]amino]propan-2-ol,67151-63-7,"Acute toxicity - oral: A reliable, K1 key acute oral toxicity test was performed in male and female Sprague Dawley rats according to a method equivalent to OECD Guideline 401 (Mallory VT, 1983). The oral LD50 for male and female rats was determined to be 1344 mg/kg bw. Acute toxicity - inhalation: An acute inhalation study does not need to be conducted as the substance is classified as corrosive to the skin (according to REACH, Annex VIII section 8.5, column 2). In addition, reliable acute oral and acute dermal toxicity studies are available. Acute toxicity - dermal: A reliable, K1 key acute dermal toxicity test was performed in male and female New Zealand White rabbits according to a method equivalent to OECD Guideline 402 (Mallory VT, 1983b). The dermal LD50 was determined to be 3570 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7124f4f4-98eb-4ded-9348-8b9b3ba52d00/documents/debbb782-8a6f-40b9-a2ec-583f907029a2_b8a783a6-d146-4039-9f0a-bbedf9002222.html,,,,,, 1-[bis[3-(dimethylamino)propyl]amino]propan-2-ol,67151-63-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7124f4f4-98eb-4ded-9348-8b9b3ba52d00/documents/debbb782-8a6f-40b9-a2ec-583f907029a2_b8a783a6-d146-4039-9f0a-bbedf9002222.html,,oral,LD50,"1,344 mg/kg bw",adverse effect observed, 1-[bis[3-(dimethylamino)propyl]amino]propan-2-ol,67151-63-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7124f4f4-98eb-4ded-9348-8b9b3ba52d00/documents/debbb782-8a6f-40b9-a2ec-583f907029a2_b8a783a6-d146-4039-9f0a-bbedf9002222.html,,dermal,LD50,"3,570 mg/kg bw",adverse effect observed, "1-[difluoro(trifluoromethoxy)methoxy]-1,2,2-trifluoroethylene",700874-87-9,"Repeated dose Inhalation study, OECD422, GLP, Rat NOAEC for local effects: 3020 mg/m3 A repeated dose toxicity study by inhalation showed that the limited adverse effects were observed only locally on the olfactory epithelium of the rats exposed for 28 days (males) or up to 40-47 days (females). There were no systemic adverse effects. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): The NOAEC was determined in a reliable OECD guideline study conducted according to GLP principles. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The NOAEC was determined in a reliable OECD guideline study conducted according to GLP principles. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22beeb28-320b-47d9-a010-729d12541924/documents/a0d5a897-cb76-497d-afcc-8735a2e0b042_5dc23ae2-df39-4b18-b641-e45b15a7560d.html,,,,,, "1-[difluoro(trifluoromethoxy)methoxy]-1,2,2-trifluoroethylene",700874-87-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22beeb28-320b-47d9-a010-729d12541924/documents/a0d5a897-cb76-497d-afcc-8735a2e0b042_5dc23ae2-df39-4b18-b641-e45b15a7560d.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"12,000 mg/m3",,rat "1-[difluoro(trifluoromethoxy)methoxy]-1,2,2-trifluoroethylene",700874-87-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22beeb28-320b-47d9-a010-729d12541924/documents/a0d5a897-cb76-497d-afcc-8735a2e0b042_5dc23ae2-df39-4b18-b641-e45b15a7560d.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"3,020 mg/m3",adverse effect observed,rat "1-[difluoro(trifluoromethoxy)methoxy]-1,2,2-trifluoroethylene",700874-87-9, Because of the physico-chemical properties and conditions of use of the substance inhalation is the most likely route of exposure for human. An acute toxicity study conducted by inhalation showed that 4 hour-exposure to MOVE 3 vapours at the concentration of 20.65 mg/L did not cause any mortality and adverse effects on rat. No studies are available of acute toxicity by oral and dermal routes. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22beeb28-320b-47d9-a010-729d12541924/documents/0be93abe-f76c-460c-b255-6f95e7ea0b23_5dc23ae2-df39-4b18-b641-e45b15a7560d.html,,,,,, "1-[difluoro(trifluoromethoxy)methoxy]-1,2,2-trifluoroethylene",700874-87-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22beeb28-320b-47d9-a010-729d12541924/documents/0be93abe-f76c-460c-b255-6f95e7ea0b23_5dc23ae2-df39-4b18-b641-e45b15a7560d.html,,inhalation,discriminating conc.,"20,650 mg/m3",no adverse effect observed, 10-methoxy-6-methylergoline-8β-methanol,35121-60-9, Oral: The oral LD50 value of test item in Wistar rats was established to be within the range of 300-2000 mg/kg body weight. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a840f824-d772-4811-a366-9f1c4dc792a3/documents/117a604b-d50d-4945-bd92-b6a136a280fc_7cb3a65d-6af8-40aa-a949-5685896816c4.html,,,,,, 10-methoxy-6-methylergoline-8β-methanol,35121-60-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a840f824-d772-4811-a366-9f1c4dc792a3/documents/117a604b-d50d-4945-bd92-b6a136a280fc_7cb3a65d-6af8-40aa-a949-5685896816c4.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "10-Undecenamide, N-[3-(dimethylamino)propyl]-",66654-01-1,There are two reliable acute oral toxicity studies availble. The most critical LD50 is 1740 mg/kg bw according to a.i. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/576e972d-20e7-4ef9-a9aa-25a2130d944a/documents/IUC5-bddaf0e2-4067-47ba-8e45-910656d39474_e092bc01-86bb-405c-87ab-9d647ab42b2a.html,,,,,, "10-Undecenamide, N-[3-(dimethylamino)propyl]-",66654-01-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/576e972d-20e7-4ef9-a9aa-25a2130d944a/documents/IUC5-bddaf0e2-4067-47ba-8e45-910656d39474_e092bc01-86bb-405c-87ab-9d647ab42b2a.html,,oral,LD50,"1,740 mg/kg bw",, "10-undecenyl 2-cyano-3,3-diphenylpropenoate",947701-81-7,The acute oral median lethal dose (LD50) of the test material UMC in the female Wistar strain rat was estimated to be greater than 2000mg/kg bodyweight (Globally Harmonised Classification System-Unclassified). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa1c6417-b510-46e4-aba0-6e5cb670507d/documents/IUC5-4ff2b105-c6f2-451e-9647-72985e2ec0dd_e620d5a8-17f3-43d4-a17f-8d0fa2f09442.html,,,,,, "10-undecenyl 2-cyano-3,3-diphenylpropenoate",947701-81-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa1c6417-b510-46e4-aba0-6e5cb670507d/documents/IUC5-4ff2b105-c6f2-451e-9647-72985e2ec0dd_e620d5a8-17f3-43d4-a17f-8d0fa2f09442.html,,oral,LD50,"2,000 mg/kg bw",, 11-(heptylamino)undecanoic acid,68564-88-5,"An acute oral toxicity study was performed. N-heptyl-amino-11-undecanoic acid (NHAU) was administered orally in 10 males and 10 females at 3 hours interval at 10 g/kg. No mortality or clinical signs was recorded, therfore the LD0 was higher than 10g/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f9a9b3d-2002-4253-9b95-48304fd84e70/documents/9bc41617-060d-4eb4-b934-c139c60fe670_8e8e43fc-3478-434d-b31b-836dfa99d546.html,,,,,, 11-(heptylamino)undecanoic acid,68564-88-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f9a9b3d-2002-4253-9b95-48304fd84e70/documents/9bc41617-060d-4eb4-b934-c139c60fe670_8e8e43fc-3478-434d-b31b-836dfa99d546.html,,oral,LD0,"> 10,000 mg/kg bw",no adverse effect observed, 11-aminoundecanoic acid,2432-99-7,Repeated Dose 28-day oral rat toxicity study (OECD TG 407):- Rat (female/male): NOAEL = 5000 ppm (= 472 mg/kg bw for males and 507 mg/kg bw for females) ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/632dc947-b675-4946-9ed0-5c382acd0fb2/documents/IUC5-a1db65ad-c854-402e-b3ca-b6698ed5fc1a_813891cc-0eee-485d-a5b8-52109dcaa577.html,,,,,, 11-aminoundecanoic acid,2432-99-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/632dc947-b675-4946-9ed0-5c382acd0fb2/documents/IUC5-a1db65ad-c854-402e-b3ca-b6698ed5fc1a_813891cc-0eee-485d-a5b8-52109dcaa577.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,472 mg/kg bw/day,, 11-aminoundecanoic acid,2432-99-7,Oral: LD50 = 14700-21500 mg/kg bw for female rats (equivalent to OECD Guideline 401) LD0 >21500 mg/kg bw for male rats (equivalent to OECD Guideline 401)Dermal: LD0 >2000 mg/kg for female and male rats (equivalent to OECD Guideline 402) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/632dc947-b675-4946-9ed0-5c382acd0fb2/documents/IUC5-265f6cea-32b3-423a-9907-ab9cca194eba_813891cc-0eee-485d-a5b8-52109dcaa577.html,,,,,, "11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione",13951-70-7,The acute oral LD50 values of 16alpha-hydroxyprednisolone is higher than 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e19dcd6-880e-41cf-a936-024dce2a9b67/documents/a7926e40-6bd0-4cc1-81c0-1bbf174f7b8a_e0ce2104-b846-4978-860d-a8576966cfcb.html,,,,,, "11β,16α,17,21-tetrahydroxypregna-1,4-diene-3,20-dione",13951-70-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e19dcd6-880e-41cf-a936-024dce2a9b67/documents/a7926e40-6bd0-4cc1-81c0-1bbf174f7b8a_e0ce2104-b846-4978-860d-a8576966cfcb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "12,12-dimethyl-2,5,8,11,13,16,19,22-octaoxa-12-silatricosane",38495-30-6,"In a study conducted according to OECD TG 401 and in compliance with GLP, the acute oral LD50 for rats was determined to be >2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8f65ae5-7391-4510-97fc-6c343cc2c091/documents/IUC5-6e1442bc-a3b9-49dd-9d3e-a64411c74e2b_59a6de2c-cf08-4a79-90c6-a1a605a1b983.html,,,,,, "12,12-dimethyl-2,5,8,11,13,16,19,22-octaoxa-12-silatricosane",38495-30-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8f65ae5-7391-4510-97fc-6c343cc2c091/documents/IUC5-6e1442bc-a3b9-49dd-9d3e-a64411c74e2b_59a6de2c-cf08-4a79-90c6-a1a605a1b983.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 12-aminododecanoic acid,693-57-2,An assessment factor of 3 applies when deriving DNELs. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bc281ea-772c-46af-8ae9-3369b9728c5c/documents/ba87b4a9-118b-40f8-bb8a-975be873ad4e_5bb7920d-b777-458b-8e81-d7e876a57a8f.html,,,,,, 12-aminododecanoic acid,693-57-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bc281ea-772c-46af-8ae9-3369b9728c5c/documents/ba87b4a9-118b-40f8-bb8a-975be873ad4e_5bb7920d-b777-458b-8e81-d7e876a57a8f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 12-aminododecanoic acid,693-57-2,"The key study was conducted under GLP to the standardised guidelines OECD 420 and EU Method B.1 bis (awarded a reliability score of 1). The key study was conducted under GLP to the standardised guidelines OECD 402, EU Method B.3, EPA OPPTS 870.1200 and JMAFF, 12 Nohsan, Notification No. 8147. In accordance with the criteria of Klimisch (1997) it was awarded a reliability score of 1. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bc281ea-772c-46af-8ae9-3369b9728c5c/documents/7b43c7d0-2be4-4e64-90bb-7c004b1743ae_5bb7920d-b777-458b-8e81-d7e876a57a8f.html,,,,,, 12-aminododecanoic acid,693-57-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bc281ea-772c-46af-8ae9-3369b9728c5c/documents/7b43c7d0-2be4-4e64-90bb-7c004b1743ae_5bb7920d-b777-458b-8e81-d7e876a57a8f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 12-aminododecanoic acid,693-57-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bc281ea-772c-46af-8ae9-3369b9728c5c/documents/7b43c7d0-2be4-4e64-90bb-7c004b1743ae_5bb7920d-b777-458b-8e81-d7e876a57a8f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 12H-phthaloperin-12-one,6925-69-5," Repeated dose toxicity: via oral route The No Observed Adverse Effect Level (NOAEL) for the test chemical for repeated dose toxicity was considered to be 1200 mg/Kg/day. Repeated inhalation study: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 12H-phthaloperin-12-one (6925-69-5) which is reported as 3.412780170097753e-9 mmHg at 25 C. Also considering the particle size distribution of the substance the majority of the particles was found to be in the size of 150 micron which is much larger size range compared to the inhalable particulate matter .Thus, exposure to inhalable dust, mist and vapour of the chemical 12H-phthaloperin-12-one is highly unlikely. Therefore this study is considered for waiver. Repeated dermal study: The acute toxicity value for 12H-phthaloperin-12-one (6925-69-5) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that12H-phthaloperin-12-one  shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 12H-phthaloperin-12-one shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/961ae132-c143-4c87-a682-fcb89afc776c/documents/1cf6241d-744d-4677-96e3-80d75fd8cfad_eabf33ce-0b6e-4c47-b6f2-fc66fff911a6.html,,,,,, 12H-phthaloperin-12-one,6925-69-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/961ae132-c143-4c87-a682-fcb89afc776c/documents/1cf6241d-744d-4677-96e3-80d75fd8cfad_eabf33ce-0b6e-4c47-b6f2-fc66fff911a6.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat 12H-phthaloperin-12-one,6925-69-5," Acute oral toxicity: Acute oral toxicity study was conducted in order assess the toxicological profile of the test item on wistar rats. Based on the results, The LD50 of test chemical was determined to be 5000 mg/kg ,Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 4.55E-07 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rabbits for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/961ae132-c143-4c87-a682-fcb89afc776c/documents/e87f9e68-e92f-43fa-8671-e8e12bc379a9_eabf33ce-0b6e-4c47-b6f2-fc66fff911a6.html,,,,,, 12H-phthaloperin-12-one,6925-69-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/961ae132-c143-4c87-a682-fcb89afc776c/documents/e87f9e68-e92f-43fa-8671-e8e12bc379a9_eabf33ce-0b6e-4c47-b6f2-fc66fff911a6.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 12H-phthaloperin-12-one,6925-69-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/961ae132-c143-4c87-a682-fcb89afc776c/documents/e87f9e68-e92f-43fa-8671-e8e12bc379a9_eabf33ce-0b6e-4c47-b6f2-fc66fff911a6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "14H-anthra[2,1,9-mna]thioxanthen-14-one",16294-75-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 2 (early study with limited observational battery) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/951351bb-9caa-4552-86cd-b5211fe03c97/documents/IUC5-8e069bdb-b984-4ade-84d3-4abb79ce8490_633ccf47-b480-4576-9ae1-5a9d7eafb071.html,,,,,, "14H-anthra[2,1,9-mna]thioxanthen-14-one",16294-75-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/951351bb-9caa-4552-86cd-b5211fe03c97/documents/IUC5-8e069bdb-b984-4ade-84d3-4abb79ce8490_633ccf47-b480-4576-9ae1-5a9d7eafb071.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,900 mg/kg bw/day,,rat "14H-anthra[2,1,9-mna]thioxanthen-14-one",16294-75-0,A single oral dose of 15000 mg/kg did not produce adverse effects in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/951351bb-9caa-4552-86cd-b5211fe03c97/documents/IUC5-745af70e-975a-4e56-8486-36818c258e89_633ccf47-b480-4576-9ae1-5a9d7eafb071.html,,,,,, "14H-anthra[2,1,9-mna]thioxanthen-14-one",16294-75-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/951351bb-9caa-4552-86cd-b5211fe03c97/documents/IUC5-745af70e-975a-4e56-8486-36818c258e89_633ccf47-b480-4576-9ae1-5a9d7eafb071.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "14H-benz[4,5]isoquino[2,1-a]perimidin-14-one",6829-22-7,"OECD 407, GLP, rat, oral (gavage), 28 days, dose levels of 100, 300 or 1000 mg/kg bw/day, no effects observed, NOAEL >= 1000 mg/kg bw/day   ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e508731-5723-4b7c-adb5-c11e58df1abd/documents/IUC5-f850787b-2440-4cc9-bd04-53224b3975ba_9bc43e78-9ae1-46ed-aae8-5db710b5ec9c.html,,,,,, "14H-benz[4,5]isoquino[2,1-a]perimidin-14-one",6829-22-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e508731-5723-4b7c-adb5-c11e58df1abd/documents/IUC5-f850787b-2440-4cc9-bd04-53224b3975ba_9bc43e78-9ae1-46ed-aae8-5db710b5ec9c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat "14H-benz[4,5]isoquino[2,1-a]perimidin-14-one",6829-22-7,"oral, rat, OECD 401, gavage, 14 d observation, LD50 > 5000 mg/kg bw inhalation, rat, OECD 403, GLP, nose-only (aerosol), 4 h, 14 d observation, LC50 > 1817 mg/m³   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e508731-5723-4b7c-adb5-c11e58df1abd/documents/IUC5-951a2a34-258a-4b0d-81a7-fb242dbe92d8_9bc43e78-9ae1-46ed-aae8-5db710b5ec9c.html,,,,,, "14H-benz[4,5]isoquino[2,1-a]perimidin-14-one",6829-22-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e508731-5723-4b7c-adb5-c11e58df1abd/documents/IUC5-951a2a34-258a-4b0d-81a7-fb242dbe92d8_9bc43e78-9ae1-46ed-aae8-5db710b5ec9c.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "14H-benz[4,5]isoquino[2,1-a]perimidin-14-one",6829-22-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e508731-5723-4b7c-adb5-c11e58df1abd/documents/IUC5-951a2a34-258a-4b0d-81a7-fb242dbe92d8_9bc43e78-9ae1-46ed-aae8-5db710b5ec9c.html,,inhalation,LC50,"> 1,817 mg/m3",no adverse effect observed, "16,17-dimethoxyviolanthrene-5,10-dione",128-58-5, No treatment-related effects indicating local or systemic toxicity were observed in male or female animals at any of the dose levels investigated. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b93c4e3-dd24-4809-a37e-931b8abc19aa/documents/b08aa0fc-7026-4cf8-b687-6815432ddba3_39149898-ef3a-4120-ade1-5c2cf1eeb460.html,,,,,, "16,17-dimethoxyviolanthrene-5,10-dione",128-58-5, No deaths were observed up to oral dose levels of 10000 mg/kg bw and dermal dose levels of 2500 mg/kg bw in rats or at inhalational exposure of a saturation concentration of 0.32 mg/L air for 4 hours or at saturation concentration for 8 hours. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b93c4e3-dd24-4809-a37e-931b8abc19aa/documents/6084d1f4-907c-4a1b-b44a-99d1c47d56d7_39149898-ef3a-4120-ade1-5c2cf1eeb460.html,,,,,, "16,23-dihydronaphth[2',3':6,7]indolo[2,3-c]dinaphtho[2,3-a:2'3'-i]carbazole-5,10,15,17,22,24-hexone",2475-33-4, LD50 > 15000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d9bcc3b-f608-45e8-9612-c95169b13471/documents/93504c2c-bb61-488e-bd22-e139a1a4563a_4c6e1238-5cf8-4b0b-a063-1cb121a1b727.html,,,,,, "16-nitroviolanthrene-5,10-dione",128-60-9,"oral: OECD 401, LD50 > 10000 mg/kg bw inhalation: no adverse effect was observed dermal: OECD 402, LD50 > 2500 mg/kg bw  ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c992a96-69cd-488a-a5b7-6e9987f71a3d/documents/4d6d8117-f758-4acf-bc20-5ff65d5bf27e_055836ea-7357-43bb-9fcc-9e74a7c3bd71.html,,,,,, "16-nitroviolanthrene-5,10-dione",128-60-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c992a96-69cd-488a-a5b7-6e9987f71a3d/documents/4d6d8117-f758-4acf-bc20-5ff65d5bf27e_055836ea-7357-43bb-9fcc-9e74a7c3bd71.html,,oral,LD50,">=10,000 mg/kg bw",no adverse effect observed, "16-nitroviolanthrene-5,10-dione",128-60-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c992a96-69cd-488a-a5b7-6e9987f71a3d/documents/4d6d8117-f758-4acf-bc20-5ff65d5bf27e_055836ea-7357-43bb-9fcc-9e74a7c3bd71.html,,dermal,LD50,"> 2,500 mg/kg bw",no adverse effect observed, "17,18-dihydrodinaphtho[1',2',3':3,4;3'',2'',1'':9,10]perylo[1,12-efg][1,4]dioxocin-5,10-dione",6424-76-6," The LD50 (oral) was determined for male/female rats. No effects were observed up to a concentration of 5000 mg/kg bw, during a period of 14 d after application (gavage). Therefore, the LD50 is considered to be >5000 mg/kg bw. The classification criteria for CLP are not met. The LC50 (inhalation) could not be determined for male/female rats. No effects were observed during a period of 14 d after an 8 h exposure (dust). Therefore, the classification criteria for CLP are not met. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b73b7d1-356a-4b40-a725-a7eb4e022b3c/documents/ca49a421-ae7f-41a4-b313-a7d1b5267d2f_4a9ae9f5-6bcb-44f5-8521-5b0744605717.html,,,,,, "17-acetoxy-1β,2β-methanopegna-4,6-diene-3,20-dione",2701-50-0,"Oral, subacute 4 weeks (Rat-Wistar, GLP, OECD TG 407): NOAEL = 1000 mg/kg  [Schering AG, Report No. AZ07, 1998]   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch score 2 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b7d0820-6b36-4b49-8a80-7cc24f42c02f/documents/d0ca240b-581a-427d-b379-df4ed13e765d_f0e3b6f0-9601-42fb-acc3-5ed29ca2b3d6.html,,,,,, "17-acetoxy-1β,2β-methanopegna-4,6-diene-3,20-dione",2701-50-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b7d0820-6b36-4b49-8a80-7cc24f42c02f/documents/d0ca240b-581a-427d-b379-df4ed13e765d_f0e3b6f0-9601-42fb-acc3-5ed29ca2b3d6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "17-acetoxy-1β,2β-methanopegna-4,6-diene-3,20-dione",2701-50-0,"Oral (Rat, equivalent to OECD TG 423): LD50 > 2000 mg/kg Dermal (Rat, GLP, equivalent to OECD TG 402): LD50 > 2000 mg/kg Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch score 2 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b7d0820-6b36-4b49-8a80-7cc24f42c02f/documents/017c3a80-a00e-4262-b506-98ffd2d42317_f0e3b6f0-9601-42fb-acc3-5ed29ca2b3d6.html,,,,,, "17-acetoxy-1β,2β-methanopegna-4,6-diene-3,20-dione",2701-50-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b7d0820-6b36-4b49-8a80-7cc24f42c02f/documents/017c3a80-a00e-4262-b506-98ffd2d42317_f0e3b6f0-9601-42fb-acc3-5ed29ca2b3d6.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "17-acetoxy-1β,2β-methanopegna-4,6-diene-3,20-dione",2701-50-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b7d0820-6b36-4b49-8a80-7cc24f42c02f/documents/017c3a80-a00e-4262-b506-98ffd2d42317_f0e3b6f0-9601-42fb-acc3-5ed29ca2b3d6.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "3 beta,5-Dihydroxy-6 beta,7 beta;15 beta,16 beta-dimethylene-5 beta-androstan-17-one",82543-16-6,"Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg [Schering AG, Report No. X325 -draft-, 1998-11-05] Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg [Schering AG, Report No. X323 -draft-, 1998-11-05] Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a747e9f-655c-43b3-b32f-7bf2d341ac2e/documents/IUC5-314c3f9b-5af7-4edf-aa28-5acd8c038e3a_52c02230-b488-442f-868e-2669f74d5767.html,,,,,, "3 beta,5-Dihydroxy-6 beta,7 beta;15 beta,16 beta-dimethylene-5 beta-androstan-17-one",82543-16-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a747e9f-655c-43b3-b32f-7bf2d341ac2e/documents/IUC5-314c3f9b-5af7-4edf-aa28-5acd8c038e3a_52c02230-b488-442f-868e-2669f74d5767.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "3 beta,5-Dihydroxy-6 beta,7 beta;15 beta,16 beta-dimethylene-5 beta-androstan-17-one",82543-16-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a747e9f-655c-43b3-b32f-7bf2d341ac2e/documents/IUC5-314c3f9b-5af7-4edf-aa28-5acd8c038e3a_52c02230-b488-442f-868e-2669f74d5767.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "17-hydroxy-3-methoxyestra-2,5(10)-diene-17-carbonitrile",17006-17-6,"LD50 oral (rat): > 2000 mg/kg bw [Draft report, Treher 1994]LD50 dermal (rat): > 2000 mg/kg bw [Draft report, Stark 2001] ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cace60f-6db0-4081-a87d-77e7cd6a6670/documents/IUC5-d19715e1-7f5f-480c-8e90-25dae2cb3a26_3cb702c9-73d3-4c44-98ae-d7e067ba0f94.html,,,,,, "17-hydroxy-3-methoxyestra-2,5(10)-diene-17-carbonitrile",17006-17-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cace60f-6db0-4081-a87d-77e7cd6a6670/documents/IUC5-d19715e1-7f5f-480c-8e90-25dae2cb3a26_3cb702c9-73d3-4c44-98ae-d7e067ba0f94.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "17-hydroxy-3-methoxyestra-2,5(10)-diene-17-carbonitrile",17006-17-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cace60f-6db0-4081-a87d-77e7cd6a6670/documents/IUC5-d19715e1-7f5f-480c-8e90-25dae2cb3a26_3cb702c9-73d3-4c44-98ae-d7e067ba0f94.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 17β-hydroxy-17-(3-hydroxy-1-propynyl)androst-4-ene-3-one,55542-26-2,"Oral (Rat, OECD TG 423): LD50 > 2000 mg/kg[Schering AG, Report No. X560 -draft-, 2001-04-23]Dermal (Rat, OECD TG 402): LD50 > 2000 mg/kg[Schering AG, Report No. X548 -draft-, 2001-02-27] ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3342e258-aad0-4c1f-93e5-672577044de9/documents/IUC5-43660096-07d2-421b-a03b-fa4c73a9c9f0_47de382f-3986-4048-8ebc-6c4224978a23.html,,,,,, 17β-hydroxy-17-(3-hydroxypropyl)androst-4-ene-4-one,55542-27-3,"Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg[Kesla Forschung & Service KG, Report No. A03974, 2001-04-10]Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg[Kesla Forschung & Service KG, Report No. A03975, 2001-04-10] ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5dfaa0c-2205-4d92-85f6-eb1615bc98d3/documents/IUC5-fb1d6ee7-3239-4b90-bba7-e6fc9734d3db_ea48cc3a-038b-400b-9e77-cd7cf5a27c66.html,,,,,, 17β-hydroxy-1α-methyl-5-αandrostan-3-one acetate,4062-46-8,"There is no repeat-dose toxicity study with ZK 5894; read-across to results of studies with mesterolone (ZK 9226):Oral, 52 weeks (Rat-Sprague-Dawley, non-GLP, doses: 0/ 0.6/ 6.0/ 20.0 mg/kg, once daily): NOEL < 0.6 mg/kg[Schering AG, report dated 1967-12-30]Oral, 52 weeks (Dog-Beagle, non-GLP, doses: 0/ 0.6/ 3.6/ 10 mg/kg, once daily): NOEL < 0.6 mg/kg[Schering AG, report dated 1967-11-30] ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/19b6fca7-cba1-4985-9304-d9431fe49d46/documents/IUC5-67982228-1231-4237-8cea-0f2d52b25afa_044677f9-7fd7-4998-b844-b62ab88c241f.html,,,,,, 17β-hydroxy-1α-methyl-5-αandrostan-3-one acetate,4062-46-8,"There is no acute toxicity studies with ZK 5894; read-across to results of studies with mesterolone (ZK 9226):Oral (Mouse-NMRI, non-GLP): LD50 > 4000 mg/kg[Schering AG, report dated 1968-01-10]Subcutaneous (Mouse-NMRI, non-GLP): LD50 > 4000 mg/kg[Schering AG, report dated 1968-01-10]Intraperitoneal (Mouse-NMRI, non-GLP): LD50 > 4000 mg/kg[Schering AG, report dated 1968-01-10]Oral (Rat-Wistar, non-GLP): LD50 > 5000 mg/kg (aqueous suspension)[Schering AG, report dated 1966-03-02]Oral (Rat-Wistar, non-GLP): LD50 > 5000 mg/kg (oily solution)[Schering AG, report dated 1968-05-16]Oral (Dog-Beagle, non-GLP): LD50 > 1000 mg/kg[Schering AG, Report No. 1498; 1974-10-28]Intravenous (Monkey-Cynomolgus, non-GLP): LD50 > 1 mg/kg[Schering AG, Report No. 6154; 1984-07-24] ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19b6fca7-cba1-4985-9304-d9431fe49d46/documents/IUC5-9a9c4189-9d20-434b-af3e-d1829a6c8129_044677f9-7fd7-4998-b844-b62ab88c241f.html,,,,,, 17β-hydroxy-1α-methylandrost-4-ene-3-one,604-26-2,"LD50 oral (rat): > 2000 mg/kg bw [Draft report, Kurth 1996a]LD50 dermal (rat): > 2000 mg/kg bw [Draft report, Kurth 1996b] ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b2acb61-6d76-46a1-a430-41b9d27514e7/documents/IUC5-f4d0761a-c1f2-4ed7-aae7-d9b60cd20a5c_39b55ea5-d726-4aaf-a6b1-80e6248fc6fb.html,,,,,, 17β-hydroxy-1α-methylandrost-4-ene-3-one,604-26-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b2acb61-6d76-46a1-a430-41b9d27514e7/documents/IUC5-f4d0761a-c1f2-4ed7-aae7-d9b60cd20a5c_39b55ea5-d726-4aaf-a6b1-80e6248fc6fb.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 17β-hydroxy-1α-methylandrost-4-ene-3-one,604-26-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b2acb61-6d76-46a1-a430-41b9d27514e7/documents/IUC5-f4d0761a-c1f2-4ed7-aae7-d9b60cd20a5c_39b55ea5-d726-4aaf-a6b1-80e6248fc6fb.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine",106917-31-1," Repeated dose toxicity was only observed after oral administration (Sprague Dawley rats, doses of 0, 15, 150 and 1000 mg/kg bw/d, for 28 days). No adverse effects were observed during treatment. Based on the observations made in this 28 d oral toxicity study in rats the NOAEL was considered to be 1000 mg/kg bw/d. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26ee1faa-5851-4d86-aa2d-f27f289bc894/documents/7ce5d0f7-c2e1-4e8a-9dc2-6e28193123c2_1df93dff-862e-4448-823e-e599a581910a.html,,,,,, "1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine",106917-31-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26ee1faa-5851-4d86-aa2d-f27f289bc894/documents/7ce5d0f7-c2e1-4e8a-9dc2-6e28193123c2_1df93dff-862e-4448-823e-e599a581910a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1-acetyl-4-(3-dodecyl-2,5-dioxo-1-pyrrolidinyl)-2,2,6,6-tetramethylpiperidine",106917-31-1, The LD50value for acute oral toxicity in rats is > 3000 mg/kg bw. The LC50 in rats was determined to be > 2.61 mg/L (4 h exposure). There are no studies on acute dermal toxicity available. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26ee1faa-5851-4d86-aa2d-f27f289bc894/documents/59ac0b84-6af4-4973-b518-2c8b2d7cf654_1df93dff-862e-4448-823e-e599a581910a.html,,,,,, 1-allyl-3-chloro-4-fluorobenzene,121626-73-1, Data from Wacker NONS Dossier ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0bd60a3-e968-4203-aea1-dbeb652b9149/documents/721a33a2-27e6-4a34-a820-509c00b4ad88_4ef2e7f6-cb2c-4e22-ae66-53a10fce9f1d.html,,,,,, 1-amino-2-(1-methyl-1-phenoxycarbonylamino-ethyl)-oxime,518047-98-8,An acute oral study determined a LD50 between 50 and 300 mg/kg. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c32afacf-8168-44ad-a5c5-652ae7659167/documents/IUC5-93cd4e01-21e8-41e2-a2cb-fc42e162ed52_6f9658ba-5ac7-4a5b-916b-b7fbcf544569.html,,,,,, "1-amino-4-(3-amino-2,4,6-trimethyl-5-sulphoanilino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonic acid",24124-40-1,The acute oral LD 50 in the rat was determind to be >2000 mg/kg bw (males and females). For acute dermal and acute inhalation toxicity no data are currently available. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d36b577-719a-413b-8200-fcf345efb540/documents/IUC5-5a4bc401-99b1-4225-b572-c27b07daea9e_afd39cbe-76b1-4d2d-a401-04d83e78cfb3.html,,,,,, "1-amino-4-(3-amino-2,4,6-trimethyl-5-sulphoanilino)-9,10-dihydro-9,10-dioxoanthracene-2-sulphonic acid",24124-40-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d36b577-719a-413b-8200-fcf345efb540/documents/IUC5-5a4bc401-99b1-4225-b572-c27b07daea9e_afd39cbe-76b1-4d2d-a401-04d83e78cfb3.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-amino-4-(ethylamino)-9,10-dihydro-9,10-dioxoanthracene-2-carbonitrile",62570-50-7, The following No Observed Adverse Effect Levels (NOAELs) were derived: Parental NOAEL: at least 1000 mg/kg Reproduction NOAEL: at least 1000 mg/kg Developmental NOAEL: at least 1000 mg/kg ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a4d720c-735f-4629-a8a6-d0b0ba7dc3fe/documents/79891a0d-588e-4e26-973b-43f5fb3ea874_263c32a3-866d-43fc-9cdf-1a4c31b35a50.html,,,,,, "1-amino-4-(ethylamino)-9,10-dihydro-9,10-dioxoanthracene-2-carbonitrile",62570-50-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a4d720c-735f-4629-a8a6-d0b0ba7dc3fe/documents/79891a0d-588e-4e26-973b-43f5fb3ea874_263c32a3-866d-43fc-9cdf-1a4c31b35a50.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1-amino-4-(ethylamino)-9,10-dihydro-9,10-dioxoanthracene-2-carbonitrile",62570-50-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a4d720c-735f-4629-a8a6-d0b0ba7dc3fe/documents/ce3aeaf6-3332-42b8-8642-0dc4d23f01e0_263c32a3-866d-43fc-9cdf-1a4c31b35a50.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-amino-4-hydroxy-2-(2-phenoxyethoxy)anthraquinone,17418-59-6,"Kuthy 2021 Under the conditions of this study, the LD50 of the test material was found to be >5000 mg/kg bw in rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The endpoint is addressed with a guideline study that was conducted under GLP conditions. The quality of the submitted data for this endpoint is therefore considered to be high. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4723572f-afb3-436a-96ec-dcbdddf684f0/documents/be5ac1f1-937b-483a-8517-02f6d24f08bb_be247b15-9dbd-4ccd-b1b0-80ff769a11c7.html,,,,,, 1-amino-4-hydroxy-2-(2-phenoxyethoxy)anthraquinone,17418-59-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4723572f-afb3-436a-96ec-dcbdddf684f0/documents/be5ac1f1-937b-483a-8517-02f6d24f08bb_be247b15-9dbd-4ccd-b1b0-80ff769a11c7.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, 1-amino-4-hydroxy-2-phenoxyanthraquinone,17418-58-5, For systemic toxicity in male and female rats exposed to the substance by oral route for at least 28 days: NOAEL = 300 mg/kg bw/d LOAEL = 1000 mg/kg bw/d ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2458e4bc-68a3-4e35-b34d-97bf9eb7f41d/documents/IUC5-c7f23d05-5e19-4753-80c5-5606bb128b93_ac12fd7b-d133-4087-87cb-a8c7cd78ec29.html,,,,,, 1-amino-4-hydroxy-2-phenoxyanthraquinone,17418-58-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2458e4bc-68a3-4e35-b34d-97bf9eb7f41d/documents/IUC5-c7f23d05-5e19-4753-80c5-5606bb128b93_ac12fd7b-d133-4087-87cb-a8c7cd78ec29.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 1-amino-4-hydroxy-2-phenoxyanthraquinone,17418-58-5,"LD50 (oral) = ca. 7000 mg/kg bw, equivalent to 2772 mg/kg bw of active ingredient. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2458e4bc-68a3-4e35-b34d-97bf9eb7f41d/documents/IUC5-310f4866-3cfc-4b36-b39a-a072a117cf15_ac12fd7b-d133-4087-87cb-a8c7cd78ec29.html,,,,,, 1-amino-4-hydroxy-2-phenoxyanthraquinone,17418-58-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2458e4bc-68a3-4e35-b34d-97bf9eb7f41d/documents/IUC5-310f4866-3cfc-4b36-b39a-a072a117cf15_ac12fd7b-d133-4087-87cb-a8c7cd78ec29.html,,oral,LD50,"2,772 mg/kg bw",no adverse effect observed, 1-Amino-4-oxocyclohexanecarboxylic acid ethylene ketal,54621-18-0,"No experimental data on acute toxicity of the test item is available. An in silico and read-across prediction for acute oral toxicity was conducted on Feb 6, 2024 using four different tools (DEREK, Leadscope, EPA TEST, OECD TB). The test item was predicted to have an acute oral toxicity and shall be classified with Cat. 3. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a90359f-688a-444d-9a1e-6f3c1680de51/documents/6946dd4d-90a4-4e92-92a2-bb6eebf45f14_a2c22d07-b79f-4d9e-a49c-3bf9b49a8439.html,,,,,, 1-benzhydrylpiperazine,841-77-0," Repeated dose toxicity - oral: In a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the test substance was administered daily to rats up to a dose level of 30 mg/kg body weight/day (OECD 422; Otterdijk F, 2017). The NOAEL is established as 10 mg/kg body weight/day. The substance is therefore classified as STOT RE 1 according to CLP Regulation. Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f141e6b-255f-4ee8-8976-a70a8f347600/documents/7644a455-e5f8-4704-b24d-e1b315a0e082_715186be-babd-4bb2-8404-29047cb4d287.html,,,,,, 1-benzhydrylpiperazine,841-77-0,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f141e6b-255f-4ee8-8976-a70a8f347600/documents/7644a455-e5f8-4704-b24d-e1b315a0e082_715186be-babd-4bb2-8404-29047cb4d287.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat 1-benzhydrylpiperazine,841-77-0," Acute toxicity: Oral: In an acute oral toxicity study in female Crl:WI (Han) (SPF) rats, following the acute toxic class method in accordance with the OECD Guideline 423 and EU Method B.1 tris, the LD50 was established to be within the range of 50 - 300 mg/kg. According to the OECD 423 guideline, the LD50 cut-off value was considered to be 300 mg/kg body weight (Latour, 2016). Toxicity was observed on central nervous system after single exposure (hunched posture, uncoordinated movements and/or piloerection). Acute toxicity: Inhalation: In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For T000750, a key study is available for the dermal route of exposure. Therefore, an acute inhalation toxicity study should not be performed. Acute toxicity: Dermal: In an acute dermal toxicity study in male and female Crl:WI (Han) (SPF) rats, following the standard acute method according to OECD Guideline 402 and EC method B.3, the LD50 was established to exceed 2000 mg/kg body weight (Latour, 2016). ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f141e6b-255f-4ee8-8976-a70a8f347600/documents/d124f70a-74a2-4c71-8ba6-7ef55911ab0a_715186be-babd-4bb2-8404-29047cb4d287.html,,,,,, 1-benzhydrylpiperazine,841-77-0,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f141e6b-255f-4ee8-8976-a70a8f347600/documents/d124f70a-74a2-4c71-8ba6-7ef55911ab0a_715186be-babd-4bb2-8404-29047cb4d287.html,,oral,LD50,300 mg/kg bw,adverse effect observed, 1-benzhydrylpiperazine,841-77-0,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f141e6b-255f-4ee8-8976-a70a8f347600/documents/d124f70a-74a2-4c71-8ba6-7ef55911ab0a_715186be-babd-4bb2-8404-29047cb4d287.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-benzyl-3,4-dimethylpyridinium chloride",22185-44-0, CERB Study N° 20030485ST Acute oral toxicity study in the rat: Acute toxic class method (OECD 423) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87297a79-ba5f-4cde-b7b9-de9e9774a375/documents/68fb0740-2d1c-4ecf-85c4-a623e272cf08_ffb2b88e-11d4-4f0e-bed2-50e660965a54.html,,,,,, 1-benzyl-3-carbamoylpyridinium chloride,5096-13-9, The oral LD50 of the test substance after single application to female Wistar rats is 1000 mg/kg bw (test procedure in accordance with OECD 423). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c9d5021-11bb-45e1-972d-24fda01189d1/documents/b288600c-ff90-407e-9330-627a2ac9a0e9_acb10bf3-fe80-428a-b35d-886a74f3ca70.html,,,,,, 1-benzyl-3-carbamoylpyridinium chloride,5096-13-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c9d5021-11bb-45e1-972d-24fda01189d1/documents/b288600c-ff90-407e-9330-627a2ac9a0e9_acb10bf3-fe80-428a-b35d-886a74f3ca70.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, 1-benzyl-3-carboxylatopyridinium sodium chloride,68133-60-8,"OECD 422: NOAEL = 1000 mg/kg bw/day (WIL Research Europe, 2013) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3bce7da1-98f2-4e72-96fb-654dc697801f/documents/IUC5-16f5a82b-9b61-4b67-bcad-b52cb37001b9_57249daa-bef3-4fb9-aa68-b9b0cf9655ea.html,,,,,, 1-benzyl-3-carboxylatopyridinium sodium chloride,68133-60-8,"LD50(oral) > 2000 mg/kg bw (Bioassay, 2013)LD50(dermal) > 2000 mg/kg bw (Bioassay, 2013) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bce7da1-98f2-4e72-96fb-654dc697801f/documents/IUC5-062a396b-d652-493e-babd-cf1cde645a64_57249daa-bef3-4fb9-aa68-b9b0cf9655ea.html,,,,,, 1-benzyl-N-phenylpiperidin-4-amine,1155-56-2," Acute toxicity: oral In a GLP compliant K1 acute oral toxicity study in female Crl:WI (Han) (SPF) rats, following the acute toxic class method in accordance with the OECD Guideline 423, EU Method B.1 tris and EPA OPPTS 870.1100, the LD50 was established to exceed 2000 mg/kg body weight (Latour, 2017). In addition, in a supporting K4 study in rats, an acute oral LD50 value of 311 mg/kg body weight was established (Schellekens, 1990). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/941276a7-dd7b-4937-8a20-035111f2f53d/documents/15c4c381-5623-46bf-98b6-1affc989f60c_11be35e3-2654-41c3-b860-3a1796e4b4bc.html,,,,,, 1-benzyl-N-phenylpiperidin-4-amine,1155-56-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/941276a7-dd7b-4937-8a20-035111f2f53d/documents/15c4c381-5623-46bf-98b6-1affc989f60c_11be35e3-2654-41c3-b860-3a1796e4b4bc.html,,oral,LD50,311 mg/kg bw,adverse effect observed, 1-bromo-2-phenylethane,103-63-9, Acute oral toxicity ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99e06c7f-54b7-4d8f-a86b-bc2d4296576e/documents/3b4d79e4-2014-40ad-a501-fa8866247b57_206c6321-c1ce-4551-8d7f-1f7952b8317c.html,,,,,, 1-bromo-2-phenylethane,103-63-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99e06c7f-54b7-4d8f-a86b-bc2d4296576e/documents/3b4d79e4-2014-40ad-a501-fa8866247b57_206c6321-c1ce-4551-8d7f-1f7952b8317c.html,,oral,LD50,"1,476 mg/kg bw",, 1-bromo-3-chloro-2-methylpropane,6974-77-2," The acute oral toxicity of 1 -bromo-3 -chloro-2 -methylpropane was invesigated in four groups of five male and five female CD rats. Under this test conditions the acute oral median lethal dosage (LD50) of 1 -bromo-3 -chloro-2 -methylpropane was 2248 mg/kg for males, 2239 mg/kg for females and 2243 mg/kg combined. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4c7972f-ebe3-451c-a3cd-ff5137b6a562/documents/30ef14fc-a0c7-434e-bea6-13b039e205e6_db6590f1-ec86-42a2-904e-5b223a33557c.html,,,,,, 1-bromo-3-chloro-2-methylpropane,6974-77-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4c7972f-ebe3-451c-a3cd-ff5137b6a562/documents/30ef14fc-a0c7-434e-bea6-13b039e205e6_db6590f1-ec86-42a2-904e-5b223a33557c.html,,oral,LD50,"2,243 mg/kg bw",adverse effect observed, 1-bromo-3-chloropropane,109-70-6,"The following key studies including 2 study reports have been selected to determinate the acute toxicity of 1-bromo-3-chloropropane :- acute oral toxicity in the rat (Denton S.M.)- acute dermal toxicity in the rat (Denton S.M.)- characteristics of the General Toxic, Gonadatropic, and Mutagenic Effects of 1,3-chlorobromopropane (Toksikologiya Novykh Promyshlennykh Khimicheskikh Veshchestv) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd9ff622-80aa-47ef-bab5-d8ebfa425fdd/documents/IUC5-b242be6e-ca65-43b8-a487-a9a42ae75924_7b5d7262-9726-4871-9e95-000de4b802ca.html,,,,,, 1-bromo-3-chloropropane,109-70-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd9ff622-80aa-47ef-bab5-d8ebfa425fdd/documents/IUC5-b242be6e-ca65-43b8-a487-a9a42ae75924_7b5d7262-9726-4871-9e95-000de4b802ca.html,,oral,LD50,"1,100 mg/kg bw",, 1-bromo-3-chloropropane,109-70-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd9ff622-80aa-47ef-bab5-d8ebfa425fdd/documents/IUC5-b242be6e-ca65-43b8-a487-a9a42ae75924_7b5d7262-9726-4871-9e95-000de4b802ca.html,,dermal,LD50,"2,000 mg/kg bw",, 1-bromo-3-chloropropane,109-70-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd9ff622-80aa-47ef-bab5-d8ebfa425fdd/documents/IUC5-b242be6e-ca65-43b8-a487-a9a42ae75924_7b5d7262-9726-4871-9e95-000de4b802ca.html,,inhalation,LC50,7.27 mg/m3,, 1-bromo-4-chlorobutane,6940-78-9, Both acute oral and dermal toxicities were examined. 1 -Bromo-4 -chlorobutane has slight toxicity for oral and low toxicity for dermal. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2995eb52-71ce-4170-96a8-568aacdfb252/documents/cb8ddc20-45d9-41ca-90a7-d3df9305dfae_679c7af7-789b-4de4-8329-2a5a1464d463.html,,,,,, 1-bromo-4-chlorobutane,6940-78-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2995eb52-71ce-4170-96a8-568aacdfb252/documents/cb8ddc20-45d9-41ca-90a7-d3df9305dfae_679c7af7-789b-4de4-8329-2a5a1464d463.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, 1-bromo-4-chlorobutane,6940-78-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2995eb52-71ce-4170-96a8-568aacdfb252/documents/cb8ddc20-45d9-41ca-90a7-d3df9305dfae_679c7af7-789b-4de4-8329-2a5a1464d463.html,,inhalation,LC50,"1,885 mg/m3",adverse effect observed, 1-bromobutane,109-65-9," Read across to 1-bromopropane. Whole-body inhalation exposure of Sprague-Dawley CD rats to a vapour of 1-bromopropane for 6 hours each day, 5 days each week, for a 13-week period, at chamber concentrations of 0.5 to 3.0 mg/L produced no clinical observations which were considered to be related to treatment. Four mortalities occurred during bleeding procedures or anaesthesia but were not considered to be related to treatment. There were no obvious effects on body weight, food consumption, urinalysis, ophthalmology, functional observational battery or motor activity that could be attributed to treatment with 1-bromopropane. No treatment-related trends were evident in hematology, blood biochemistry analysis or gross pathology. There was a marginal increase in relative liver weights in Group 5 (3.0 mg/L- high dose) males. This effect was considered of questionable toxicological significance as intergroup differences were minimal and the effect was not observed in the Group 5 (3.0 mg/L-high dose) females. However, histopathological lesions were present in the liver (vacuolation of centrolobular hepatocytes) when exposed at concentrations of 2.0 mg/L (intermediate/high dose) and 3.0 mg/L (high dose). The No Effect Level was therefore identified as 1.0 mg/L. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/689d3562-c0b5-43b8-be13-b03029c5ea54/documents/20e69fc3-c922-4ab3-bcc8-777752eebf7a_de30980e-add4-47dc-859f-2da4b502a66e.html,,,,,, 1-bromobutane,109-65-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/689d3562-c0b5-43b8-be13-b03029c5ea54/documents/20e69fc3-c922-4ab3-bcc8-777752eebf7a_de30980e-add4-47dc-859f-2da4b502a66e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat 1-bromobutane,109-65-9, Acute toxicity oral The acute oral LD50 in male Sprague-Dawley rats was calculated to be 2760.6 mg/kg of body weight; the oral LD50 in females was calculated to be 3160.8 mg/kg of body weight. Acute toxicity inhalation LCLO(4 hour) for n-butyl bromide as a vapour is in excess of 25.4 mg/l in air. Acute dermal toxicity LD0 of the test substance n-BUTYL BROMIDE was higher than or equal to 2000 mg/kg in rats. No signs of toxicity were observed at this dose. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/689d3562-c0b5-43b8-be13-b03029c5ea54/documents/c8b55e32-353f-4389-bea1-1bb2bb990372_de30980e-add4-47dc-859f-2da4b502a66e.html,,,,,, 1-bromobutane,109-65-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/689d3562-c0b5-43b8-be13-b03029c5ea54/documents/c8b55e32-353f-4389-bea1-1bb2bb990372_de30980e-add4-47dc-859f-2da4b502a66e.html,,oral,LD50,"2,760.6 mg/kg bw",no adverse effect observed, 1-bromobutane,109-65-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/689d3562-c0b5-43b8-be13-b03029c5ea54/documents/c8b55e32-353f-4389-bea1-1bb2bb990372_de30980e-add4-47dc-859f-2da4b502a66e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-bromobutane,109-65-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/689d3562-c0b5-43b8-be13-b03029c5ea54/documents/c8b55e32-353f-4389-bea1-1bb2bb990372_de30980e-add4-47dc-859f-2da4b502a66e.html,,inhalation,,"25,400 mg/m3",no adverse effect observed, 1-bromodecane,112-29-8,Acute toxicity: oralThe acute oral toxicity of 1-bromodecane was determined to be > 2000 mg/kg according to the key study which was performed in line with OECD guideline 423. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9db888f8-e311-4c3d-802e-ccd2e39714f2/documents/IUC5-4d5159a4-6179-4caf-aa09-5f5da794dba9_fcfab957-11f9-40cd-9848-d163cdda8d66.html,,,,,, 1-bromododecane,143-15-7,"The acute oral median lethal doser (LD50) of the test material in the female Spraque-Dawlley CD strain rat was esimtated as being reater than 2500 mg/kg bodywieght, and actue dermal median lethal doser (LD50) as greater than 2000 mg/kg bodywight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc92f13e-5a62-47db-a62e-bfb7ca279c52/documents/IUC5-d1bc9dea-8780-4223-ae38-3e9136586c57_84ff12e1-991e-4524-8371-86668732e9b7.html,,,,,, 1-bromododecane,143-15-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc92f13e-5a62-47db-a62e-bfb7ca279c52/documents/IUC5-d1bc9dea-8780-4223-ae38-3e9136586c57_84ff12e1-991e-4524-8371-86668732e9b7.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, 1-bromododecane,143-15-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc92f13e-5a62-47db-a62e-bfb7ca279c52/documents/IUC5-d1bc9dea-8780-4223-ae38-3e9136586c57_84ff12e1-991e-4524-8371-86668732e9b7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-bromohexane,111-25-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f10007c-ffe4-4b51-990a-f0a2f4aa6730/documents/IUC5-f5dd5815-2927-4c44-98b2-1d9239f1e54a_9cb29be3-f884-463f-9b76-30d88e409cb3.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-bromopentane,110-53-2,"Oral exposureIn a GLP-compliant acute toxicity study conducted in accordance with standardised guideline OECD 420, the LD50 of the test material was calculated by exposing 4 females Wistar rats to a dose of 2000 mg/kg of body weight by oral gavage. Under the conditions of the test no systemic signs of toxicity were reported over a period of 14 days and the LD50 was determined to be > 2000 mg/kg.Dermal exposureIn a GLP-compliant acute toxicity study conducted in accordance with standardised guideline OECD 402, the LD50 of the test material was calculated by exposing 5 males and 5 females Wistar rats to a dose of 2000 mg/kg of body weight by contact. Under the conditions of the test no systemic signs of toxicity were reported over a period of 14 days and the LD50 was determined to be > 2000 mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56f02695-782d-4604-91c2-687ee8f968d5/documents/IUC5-bc694260-4019-4c7d-91e2-1f6428734591_30484367-c460-46af-bb79-9652d7327753.html,,,,,, Tributylmethylammoniummethylsulfate,13106-24-6," oral: rat, OECD 423, limit test: LD 50 > 2000 mg/kg bw (1/6 animals died at 2000mg/kg bw, possible application error), (BASF, 1998) inhalation: no data available dermal: no data available ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed51fa01-d6ce-4114-97eb-55e405348ae1/documents/IUC5-708c036b-ef70-4fc1-9810-3743a89dff7a_a9f2d448-ba66-4252-b4ef-6d5eaedbca51.html,,,,,, Tributylmethylammoniummethylsulfate,13106-24-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed51fa01-d6ce-4114-97eb-55e405348ae1/documents/IUC5-708c036b-ef70-4fc1-9810-3743a89dff7a_a9f2d448-ba66-4252-b4ef-6d5eaedbca51.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 3-aminobutan-1-ol,61477-40-5,"LD50(oral,rat): > 300 <2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/917e2ef3-0985-41ea-b93c-9068142ef320/documents/IUC5-d97ce37f-0edd-4cab-8be4-15d6ab6227a9_dbf835e6-3ed1-4aec-b41e-6bef26477ad1.html,,,,,, 3-aminobutan-1-ol,61477-40-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/917e2ef3-0985-41ea-b93c-9068142ef320/documents/IUC5-d97ce37f-0edd-4cab-8be4-15d6ab6227a9_dbf835e6-3ed1-4aec-b41e-6bef26477ad1.html,,oral,LD50,300 mg/kg bw,adverse effect observed, 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one,119344-86-4,"- oral: NOAEL = 50 mg/kg/day (4 weeks, gavage)- oral: NOEL = 15 mg/kg/day (4 weeks, gavage) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b056c1a4-57ec-4919-94ef-1f73b41c95f6/documents/IUC5-f51c368d-e4df-425c-a1b8-98e17bbe4941_d77216b6-de95-4246-b7ea-896e38d57119.html,,,,,, 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one,119344-86-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b056c1a4-57ec-4919-94ef-1f73b41c95f6/documents/IUC5-f51c368d-e4df-425c-a1b8-98e17bbe4941_d77216b6-de95-4246-b7ea-896e38d57119.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one,119344-86-4,"Acute oral toxicity: LD50 > 2000 mg/kg bw (rat); OECD Guideline Study, RCC 2001Aucte dermal toxicity: LD50 > 2000 mg/kg bw (rat); OECD Guideline Study, RCC 2001 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b056c1a4-57ec-4919-94ef-1f73b41c95f6/documents/IUC5-3f46822d-c45a-475c-8ce0-95e1f9a81efb_d77216b6-de95-4246-b7ea-896e38d57119.html,,,,,, 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one,119344-86-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b056c1a4-57ec-4919-94ef-1f73b41c95f6/documents/IUC5-3f46822d-c45a-475c-8ce0-95e1f9a81efb_d77216b6-de95-4246-b7ea-896e38d57119.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-(dimethylamino)-2-[(4-methylphenyl)methyl]-1-[4-(morpholin-4-yl)phenyl]butan-1-one,119344-86-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b056c1a4-57ec-4919-94ef-1f73b41c95f6/documents/IUC5-3f46822d-c45a-475c-8ce0-95e1f9a81efb_d77216b6-de95-4246-b7ea-896e38d57119.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "reaction mass of:(3S)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone and(3R)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone and(3S)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone and(3R)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone",878665-13-5," Repeated dose toxicity oral: NOEL = 1000 mg/kg bw/d (GLP, OECD 407, rel. 1, K) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7bb19606-84b6-439f-92ba-fc9238d71bd9/documents/IUC5-8fa4a4e5-a952-49e3-817a-f51e0807abe5_398c91bd-d19b-4829-9519-2259a1bc08e6.html,,,,,, "reaction mass of:(3S)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone and(3R)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone and(3S)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone and(3R)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone",878665-13-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7bb19606-84b6-439f-92ba-fc9238d71bd9/documents/IUC5-8fa4a4e5-a952-49e3-817a-f51e0807abe5_398c91bd-d19b-4829-9519-2259a1bc08e6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "reaction mass of:(3S)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone and(3R)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone and(3S)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone and(3R)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone",878665-13-5," - Acute oral toxicity: LD50 > 5000 mg/kg bw  (limit test according to OECD 423, GLP, rel.1, K). - Acute dermal toxicity: LD50 > 2000 mg/kg bw (limit test according to OECD 402, GLP, rel. 1, K). - Acute toxicity: inhalation: no data ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bb19606-84b6-439f-92ba-fc9238d71bd9/documents/IUC5-826cd0c3-e9a8-45ed-8b12-f69f0d6621dc_398c91bd-d19b-4829-9519-2259a1bc08e6.html,,,,,, "reaction mass of:(3S)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone and(3R)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone and(3S)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone and(3R)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone",878665-13-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bb19606-84b6-439f-92ba-fc9238d71bd9/documents/IUC5-826cd0c3-e9a8-45ed-8b12-f69f0d6621dc_398c91bd-d19b-4829-9519-2259a1bc08e6.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "reaction mass of:(3S)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone and(3R)-3-(dodecylthio)-1-[(1S,2R)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone and(3S)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone and(3R)-3-(dodecylthio)-1-[(1R,2S)-2,6,6-trimethyl-3-cyclohexen-1-yl]-1-butanone",878665-13-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bb19606-84b6-439f-92ba-fc9238d71bd9/documents/IUC5-826cd0c3-e9a8-45ed-8b12-f69f0d6621dc_398c91bd-d19b-4829-9519-2259a1bc08e6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-Butoxy-4-[4-(trans-4-ethylcyclohexyl)-1-cyclohexen-1-yl]-2,3-difluorobenzene",1003218-33-4," OECD 423: LD50 (rat, oral) > 2000 mg/kg bw ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e087a63-2f46-4672-aa4f-602523e2e422/documents/2654b5a0-cbae-48b4-8c14-6585bfe9701d_f49252a7-50e8-40be-932c-b17d42d70b48.html,,,,,, "1-Butoxy-4-[4-(trans-4-ethylcyclohexyl)-1-cyclohexen-1-yl]-2,3-difluorobenzene",1003218-33-4,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e087a63-2f46-4672-aa4f-602523e2e422/documents/2654b5a0-cbae-48b4-8c14-6585bfe9701d_f49252a7-50e8-40be-932c-b17d42d70b48.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1-butyl-5-[(4-chlorophenyl)azo]-1,2-dihydro-6-hydroxy-4-methyl-2-oxonicotinonitrile",69808-32-8,"According to OECD 423 Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The objective of this study is to evaluate the acute oral toxicity of the test item in female Sprague-Dawley rats by the Acute Toxic Class Method (OECD guideline Nº 423). The dose level to be used as the starting dose will be 300 mg/kg body weight, since the Sponsor has no information on the toxicity of the test item. This method allows the test item to be classified according to the Globally Harmonised System (GHS) for the determination of the toxicity of chemicals. The limit test is based on a stepwise procedure at one dose level of 300 mg/kg, which is carried out with six animals in two steps (three animals per step). The follow up doses were selected according the following scheme. After an observation period, test item-related mortality of the animals dosed at one step determined the next one. The time interval between doses was determined by the onset, duration, and severity of toxic signs. Animal treatment at the next dose was delayed until survival rate of previously dosed animals was determined. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f59d820-3dee-4f6b-8546-d97e0626f1a3/documents/d40e4255-f04e-4801-9449-b8d6100280e3_419f143b-57de-49bb-b015-1008b16898c5.html,,,,,, "1-butyl-5-[(4-chlorophenyl)azo]-1,2-dihydro-6-hydroxy-4-methyl-2-oxonicotinonitrile",69808-32-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f59d820-3dee-4f6b-8546-d97e0626f1a3/documents/d40e4255-f04e-4801-9449-b8d6100280e3_419f143b-57de-49bb-b015-1008b16898c5.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "1-Butyloxy-2,3-difluor-4-(4-trans-propylcyclohexyl)-benzene",208709-55-1, For this endpoint information from a structural similar compound is available. The study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 407. The NOAEL observed for the source compound is 450 mg/kg bw / d. See chapter 13 report for a more detailed justification. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b29d5d9-d60f-42c4-9057-5e58f2a04e9f/documents/1085b6c4-c11e-40d5-ac19-1ec0aea6ddc5_122d573b-9079-4caa-91de-e1438d8341a0.html,,,,,, "1-Butyloxy-2,3-difluor-4-(4-trans-propylcyclohexyl)-benzene",208709-55-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b29d5d9-d60f-42c4-9057-5e58f2a04e9f/documents/1085b6c4-c11e-40d5-ac19-1ec0aea6ddc5_122d573b-9079-4caa-91de-e1438d8341a0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat "1-Butyloxy-2,3-difluor-4-(4-trans-propylcyclohexyl)-benzene",208709-55-1, For this endpoint information from a structural similar compound is available. The acute oral toxicity study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 423. See chapter 13 report for a more detailed justification. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b29d5d9-d60f-42c4-9057-5e58f2a04e9f/documents/IUC5-40640b6d-b7cd-467b-b7a7-21b1e3b40d0b_122d573b-9079-4caa-91de-e1438d8341a0.html,,,,,, "1-Butyloxy-2,3-difluor-4-(4-trans-propylcyclohexyl)-benzene",208709-55-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b29d5d9-d60f-42c4-9057-5e58f2a04e9f/documents/IUC5-40640b6d-b7cd-467b-b7a7-21b1e3b40d0b_122d573b-9079-4caa-91de-e1438d8341a0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-butylpyrrolidin-2-one,3470-98-2,"- Key study: 90-Day repeated dose toxicity study (GLP, OECD 408): oral (gavage), Wistar rats, dose levels: 10, 100 and 500 mg/kg bw; NOAEL: 500 mg/kg bw; NOEL: 10 mg/kg bw (males), 100 mg/kg bw (females). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba4f7bc3-93ab-4984-a043-34769eca79f9/documents/IUC5-07fc51ea-235b-42fd-b2c3-813f00923272_bfaca997-025a-49c2-9f3d-5d5b4a99de86.html,,,,,, 1-butylpyrrolidin-2-one,3470-98-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba4f7bc3-93ab-4984-a043-34769eca79f9/documents/IUC5-07fc51ea-235b-42fd-b2c3-813f00923272_bfaca997-025a-49c2-9f3d-5d5b4a99de86.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat 1-butylpyrrolidin-2-one,3470-98-2," - Acute oral toxicity: LD50 of 300-2000 mg/kg bw (OECD 423; Wistar rats; clinical signs, deaths, no effects on body weights and no findings at necropsy). - Acute inhalation toxicity: LC50 > 5.1 mg/L (OECD 403, EPA OPPTS Guideline 870.1300; Crl:CD(SD) rats; no death, clinical signs included laboured respiration, ataxia, prostratio, hypoactivity, clonic convulsions, body cool to touch, red material around the nose, partial closure of the eye(s) unkempt appearance, impaired equilibrium and decreased defecation and urination) - Acute dermal toxicity: LD50 > 2000 mg/kg bw (OECD 402; Wistar rats; no effects). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba4f7bc3-93ab-4984-a043-34769eca79f9/documents/IUC5-070989a0-85ed-4b9c-884a-4eb2c22fc906_bfaca997-025a-49c2-9f3d-5d5b4a99de86.html,,,,,, 1-butylpyrrolidin-2-one,3470-98-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba4f7bc3-93ab-4984-a043-34769eca79f9/documents/IUC5-070989a0-85ed-4b9c-884a-4eb2c22fc906_bfaca997-025a-49c2-9f3d-5d5b4a99de86.html,,oral,LD50,300 mg/kg bw,adverse effect observed, 1-butylpyrrolidin-2-one,3470-98-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba4f7bc3-93ab-4984-a043-34769eca79f9/documents/IUC5-070989a0-85ed-4b9c-884a-4eb2c22fc906_bfaca997-025a-49c2-9f3d-5d5b4a99de86.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-butylpyrrolidin-2-one,3470-98-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba4f7bc3-93ab-4984-a043-34769eca79f9/documents/IUC5-070989a0-85ed-4b9c-884a-4eb2c22fc906_bfaca997-025a-49c2-9f3d-5d5b4a99de86.html,,inhalation,LC50,"5,100 mg/m3",no adverse effect observed, 1-chloro-3-(4-chlorophenoxy) benzene,6842-62-2,"Concerning the acute oral toxicity of 3,4'-dichlorodiphenyl ether two in vivo studies were performed. Both studies comply with the OECD Principles of Good Laboratory Practice (GLP). In the 1994 study 5 male and 5 female Wistar rats were dosed at a dose level of 2000 mg/kg bw. At this dose no animal died and no signs of toxicity or changes in body weight development were observed during the observation period of 14 days. Therefore the LD50 was regarded to be > 2000 mg/kg bw for both gender and not determined exactly (limit test according to OECD TG 401). In the 2006 study 3 female Sprague Dawley rats were dosed at a level of 2000 mg/kg bw (step 1). Two animals died on Day 4 of the observation period. Then additional 3 females were dosed at 300 mg/kg bw (step 2) and observed for a period of 14 days. No mortality occurred and no clinical signs were observed. Finally 3 females were dosed at the same dose level, 300 mg/kg bw (step 3). Again no mortality and no clinical signs occurred. No remarkable changes in body weight were observed in the surviving animals. Thus the results of this study indicate that the test item, 3,4'-dichlorodiphenyl ether, has a toxic effect on the rat following oral administration of single dose of 2000 mg/kg bw. No mortality or other signs of toxicity were observed at 300 mg/kg. The mortality pattern demonstrates the acute oral LD50 to be less than 2000 mg/kg bw, but greater than 300 mg/kg bw. The LD50 cut-off amounts 1000 mg/kg bw.   Based on the data obtained under the conditions of the 1994 study the test substance 3,4'-dichlorodiphenyl ether should not be classified according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures(CLP).   Based on the data obtained under the conditions of the 2006 study, the test substance 3,4'-dichlorodiphenyl ether should be classified as Acute Tox. 4, H302 (Harmful if swallowed) according to Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures(CLP).   There is no obvious reason explaining the different test results in the two studies on Acute Oral Toxicity. Both studies are in accordance with OECD guidelines in force at time of study conduction (OECD TG 401 and OECD TG 423, respectively). Further on both studies are quality checked and in compliance with the Principles of Good Laboratory Practice. There are also no known interstrain differences between Wistar or Sprague Dawley rats with respect to the sensitivity on acute oral toxicity. The purity of both test items was high but nevertheless there may be different contaminants or side products in the test item which have not been reported. Therefore it may be possible that unknown components or influences had an impact on the study results. This can not finally be assessed. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/881bba86-c4dc-498d-9576-80eb03fd88da/documents/IUC5-1139ee0c-9c1f-46da-968a-11a18201f4d2_25ee9f8c-6265-4980-a57f-2f59ccd899f7.html,,,,,, 1-chloro-3-(4-chlorophenoxy) benzene,6842-62-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/881bba86-c4dc-498d-9576-80eb03fd88da/documents/IUC5-1139ee0c-9c1f-46da-968a-11a18201f4d2_25ee9f8c-6265-4980-a57f-2f59ccd899f7.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, 1-chlorobutane,109-69-3,"90 days oral NOAEL (rats) = 120 mg/kg bw/day (NTP, 1986)90 days oral LOAEL (rats) = 250 mg/kg bw/day (NTP, 1986)2-years oral NOAEL (rats) = 60 mg/kg bw/day (NTP, 1986) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d12d75f-ab49-4d6a-a1c8-d9ef06df3efd/documents/IUC5-72514684-5a32-4fb6-ab6b-6264cba4b275_e073e708-f24b-4943-968f-853c80b5110c.html,,,,,, 1-chlorobutane,109-69-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d12d75f-ab49-4d6a-a1c8-d9ef06df3efd/documents/IUC5-72514684-5a32-4fb6-ab6b-6264cba4b275_e073e708-f24b-4943-968f-853c80b5110c.html,Chronic toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat 1-chlorobutane,109-69-3,"oral: LD50 > 2000 < 5000 mg/kg bw (WoE: Rudnev et al. 1979, rat and mouse, Smyth et al. 1954, rat)inhalation: LC 50 (rat) > 7.74 mg/L air (90-0524-FGT) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d12d75f-ab49-4d6a-a1c8-d9ef06df3efd/documents/IUC5-b3bdc4c7-b686-46e7-be92-0aeaeb5fcb01_e073e708-f24b-4943-968f-853c80b5110c.html,,,,,, 1-chlorododecane,112-52-7," The only data for the assessment of repeated dose toxicity of lauryl chloride are publicly available, but proprietary data, which have been submitted to the US EPA under the Toxic Substances Control Act (TSCA). In a combined 28-day oral repeated-dose/reproductive screening study in rats (according to OECD 422 and US EPA TSCA 799.9365), the systemic NOAEL was at 100 mg/kg based on lower mean body weight gains and food consumption at 1000 mg/kg and lower mean thymus gland weights at 300 and 1000 mg/kg. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/15e5f485-c08c-4741-98cd-33047216866a/documents/0bea7590-84cb-4f4a-a1d9-f9c6ab6d836e_d1f7bbc1-ffe7-4150-af91-e347b5e0e69c.html,,,,,, "1-chloro-N,N-diethyl-1,1-diphenyl-1-(phenylmethyl)phosphoramine",82857-68-9,A subacute oral study is available.Rats were exposed to GM102E during 28 days and the only effect attributable to the treatment is salivation in animals treated with 25 and 50 mg/kg/day. Thus the NOAEL is 50 mg/kg/day and the NOEL is 12.5 mg/kg/day. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1f00613-6e80-42d3-9361-5805bc81dd9a/documents/IUC5-8569d591-a444-46eb-a51f-faf57dd65f05_98270547-3690-4277-ae67-57afa9c32f3a.html,,,,,, "1-chloro-N,N-diethyl-1,1-diphenyl-1-(phenylmethyl)phosphoramine",82857-68-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1f00613-6e80-42d3-9361-5805bc81dd9a/documents/IUC5-8569d591-a444-46eb-a51f-faf57dd65f05_98270547-3690-4277-ae67-57afa9c32f3a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "1-chloro-N,N-diethyl-1,1-diphenyl-1-(phenylmethyl)phosphoramine",82857-68-9,"- Oral: combined LD50 = 123 mg/kg bw in an OECD 401 study on rats.- Inhalation: 0.05 mg/L < combined LC50/4h < 0.5 mg/L in an OECD 403 study on rats.- Dermal: combined LD50 > 2000 mg/kg bw in an EU B.3 study on rats. One female rat died during the study. No general clinical signs were seen in the surviving animals, but they showed erythema, edema, and crusts at the application site.   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1f00613-6e80-42d3-9361-5805bc81dd9a/documents/IUC5-a2fc25f0-86ae-4c4c-8d6b-404d77139405_98270547-3690-4277-ae67-57afa9c32f3a.html,,,,,, "1-chloro-N,N-diethyl-1,1-diphenyl-1-(phenylmethyl)phosphoramine",82857-68-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1f00613-6e80-42d3-9361-5805bc81dd9a/documents/IUC5-a2fc25f0-86ae-4c4c-8d6b-404d77139405_98270547-3690-4277-ae67-57afa9c32f3a.html,,oral,LD50,123 mg/kg bw,adverse effect observed, "1-chloro-N,N-diethyl-1,1-diphenyl-1-(phenylmethyl)phosphoramine",82857-68-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1f00613-6e80-42d3-9361-5805bc81dd9a/documents/IUC5-a2fc25f0-86ae-4c4c-8d6b-404d77139405_98270547-3690-4277-ae67-57afa9c32f3a.html,,dermal,LD50,"> 2,000 mg/kg bw",adverse effect observed, "1-chloro-N,N-diethyl-1,1-diphenyl-1-(phenylmethyl)phosphoramine",82857-68-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1f00613-6e80-42d3-9361-5805bc81dd9a/documents/IUC5-a2fc25f0-86ae-4c4c-8d6b-404d77139405_98270547-3690-4277-ae67-57afa9c32f3a.html,,inhalation,LC50,> 0.05 mg/L,adverse effect observed, 1-chloropropane,540-54-5," acute toxicity, oral (OECD 401, RL1), female and male rats: LD50 > 2000 mg/kg bw acute toxicity, inhalation (OECD 403, RL2), female and rats: LC50 > 6.54 mg/L air acute toxicity, dermal (OECD 402, RL1), female and male rats: LD50 > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/504f08b7-82e4-4c53-a915-93608c1c35cf/documents/af241e44-0eba-4f2d-b648-e9906f5fd56b_3bf4edcb-2bac-4650-b314-b7cd17b45b53.html,,,,,, 1-chloropropane,540-54-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/504f08b7-82e4-4c53-a915-93608c1c35cf/documents/af241e44-0eba-4f2d-b648-e9906f5fd56b_3bf4edcb-2bac-4650-b314-b7cd17b45b53.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-chloropropane,540-54-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/504f08b7-82e4-4c53-a915-93608c1c35cf/documents/af241e44-0eba-4f2d-b648-e9906f5fd56b_3bf4edcb-2bac-4650-b314-b7cd17b45b53.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-chloropropane,540-54-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/504f08b7-82e4-4c53-a915-93608c1c35cf/documents/af241e44-0eba-4f2d-b648-e9906f5fd56b_3bf4edcb-2bac-4650-b314-b7cd17b45b53.html,,inhalation,LC50,"6,540 mg/m3",no adverse effect observed, 1-cyanoallyl acetate,15667-63-7," Oral (similar to OECD 401), rat (m, f): LD50 = 31.6 mg/kg bw (males) Inhalation (similar to OECD 403), rat (m, f): LC50 = 7.7 mg/L air (nominal, males) Dermal (similar to OECD 402), rabbit (m, f): LD50 = > 6.95 - < 15 mg/kg bw (males) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4af95946-115b-42e6-a35a-fd8fb82a8bca/documents/8590d3fb-c3a2-45b6-ae03-c82f68272167_78bb8953-c9d8-43fa-906c-48fc873150fe.html,,,,,, 1-cyanoallyl acetate,15667-63-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4af95946-115b-42e6-a35a-fd8fb82a8bca/documents/8590d3fb-c3a2-45b6-ae03-c82f68272167_78bb8953-c9d8-43fa-906c-48fc873150fe.html,,oral,LD50,31.6 mg/kg bw,adverse effect observed, 1-cyanoallyl acetate,15667-63-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4af95946-115b-42e6-a35a-fd8fb82a8bca/documents/8590d3fb-c3a2-45b6-ae03-c82f68272167_78bb8953-c9d8-43fa-906c-48fc873150fe.html,,dermal,LD50,15 mg/kg bw,adverse effect observed, 1-cyanoallyl acetate,15667-63-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4af95946-115b-42e6-a35a-fd8fb82a8bca/documents/8590d3fb-c3a2-45b6-ae03-c82f68272167_78bb8953-c9d8-43fa-906c-48fc873150fe.html,,inhalation,LC50,"7,700 mg/m3",adverse effect observed, 3-[(4R)-4-(propan-2-yl)cyclohex-1-en-1-yl]propanal,1378867-81-2,"Key study demonstrate no acute toxicity via the oral route.Data are read-across from structural analogues, i.e. 4-(4-Methyl-pent-3-enyl)-cyclohex-3-enecarbaldehyde, based on e.g., similar physico-chemical properties, molecular size, systemic uptake. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f264986-c2c8-4040-9665-7d437a86f82a/documents/IUC5-31f2631e-562d-40c9-bc01-343571ef4884_d931b9b5-ff62-4f84-be43-99d9a1fee7a0.html,,,,,, 3-[(4R)-4-(propan-2-yl)cyclohex-1-en-1-yl]propanal,1378867-81-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f264986-c2c8-4040-9665-7d437a86f82a/documents/IUC5-31f2631e-562d-40c9-bc01-343571ef4884_d931b9b5-ff62-4f84-be43-99d9a1fee7a0.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "1-cyclohexyl-1H-pyrrole-2,5-dione",1631-25-0," Under the conditions of this study it was found that 1-cyclohexyl-1H-pyrrole-2,5-dione should be classified as Acute toxicity cat 3 (oral). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b00873e-8bc0-44ed-baf0-71e2cf8ff088/documents/489c2399-dda7-4e33-bf23-7ca5ad0cec88_0a8cdd1f-5096-420e-8340-60862d84006c.html,,,,,, "1-cyclohexyl-1H-pyrrole-2,5-dione",1631-25-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b00873e-8bc0-44ed-baf0-71e2cf8ff088/documents/489c2399-dda7-4e33-bf23-7ca5ad0cec88_0a8cdd1f-5096-420e-8340-60862d84006c.html,,oral,LD50,130.3 mg/kg bw,adverse effect observed, "1-Dodecanamine, reaction products with 1,1'-methylenebis[4-isocyanatobenzene] and 1-octanamine",1312943-21-7," Short-term repeat oral toxicity studies were conducted on four substances in the MDI category: A mixture of: 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea; 3-cyclohexyl-1-(4-(4-(3-octadecylureido)benzyl)phenyl)urea; 3,3'-dioctadecyl-1,1'-methylenebis (4,1-phenylene)diurea (EC 406-530-2), 3,3'-dioctadecyl-1,1'- methylenebis(4,1-phenylene)diurea (EC 406-690-3), N,N''-(methylenedi-4,1-phenylene)bis[N'-octyl]urea (EC 445-760-8), 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-370-3), N,N''-(methylenedi- 4,1-phenylene)bis[N'-octyl]urea (EC 451-060-3). All studies were conducted over 28 days with 7 days/week dosing at three concentrations up to 1000 mg/kg bw/day. In the studies conducted on 3,3'-dioctadecyl-1,1'- methylenebis(4,1- phenylene)diurea (EC 406-690-3), A mixture of: 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea; 3-cyclohexyl-1- (4-(4-(3-octadecylureido)benzyl) phenyl)urea; 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-530-2) and 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-370-3), no treatment related findings were observed at any of the nominal concentrations tested and, therefore, the NOAEL and NOEL were determined to be 1000 mg/kg/b.w. day. In the study conducted on N,N''-(methylenedi-4,1-phenylene)bis[N'-octyl]urea (EC 445-760-8),, no treatment related findings were observed at any of the nominal concentrations tested, except for a slight slowing of body weight gain in males treated at a dose of 1000 mg/kg bw/day. Non-treatment related findings of increase in serum sodium and chloride levels in males treated with 450 and 1000 mg/kg/day and increased potassium in females at 1000 mg/kg/d were observed. Therefore, the substance was clinically well-tolerated at all doses tested and no significant variation / observation was noted in organ weights and macroscopic examination. The NOAEL and NOEL were determined to be 450 and 150 mg/kg b.w./day, respectively. All tests concluded that no classification is required. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d4829bf-bec4-4832-897d-a6996f293beb/documents/d8e6eef8-265f-423c-b43b-0e1a98826de4_54d81fa5-1cec-4d40-ad17-d08ce49c238b.html,,,,,, "1-Dodecanamine, reaction products with 1,1'-methylenebis[4-isocyanatobenzene] and 1-octanamine",1312943-21-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d4829bf-bec4-4832-897d-a6996f293beb/documents/d8e6eef8-265f-423c-b43b-0e1a98826de4_54d81fa5-1cec-4d40-ad17-d08ce49c238b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat "1-Dodecanamine, reaction products with 1,1'-methylenebis[4-isocyanatobenzene] and 1-octanamine",1312943-21-7," Acute oral toxicity studies were conducted on four MDI category members; A mixture of: 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea; 3-cyclohexyl-1-(4-(4-(3-octadecylureido)benzyl) phenyl)urea; 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-530-2), 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-370-3), N,N''-(methylenedi-4,1-phenylene) bis[N'-octyl]urea (EC 445-760-8), 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-690-3). The results from these studies showed no evidence of acute toxicity up to the highest dose tested in any study (2000 or 5000 mg/kg test item in either cellulose or corn oil). There is no evidence of a relevant intrinsic acute oral toxicity requiring classification or substance specific risk management measures.    Acute dermal toxicity limit studies were conducted on four MDI category members; A mixture of: 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea; 3-cyclohexyl-1-(4-(4-(3-octadecylureido)benzyl) phenyl)urea; 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-530-2), 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-370-3), N,N''-(methylenedi-4,1-phenylene) bis[N'-octyl]urea (EC 445-760-8), 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-690-3). The results from these studies showed no evidence of acute toxicity at the only dose tested in any study (2000 mg/kg test item). There is no evidence of a relevant intrinsic acute dermal toxicity requiring classification or substance specific risk management measures. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d4829bf-bec4-4832-897d-a6996f293beb/documents/10863561-7751-4965-a066-9780a1ef443f_54d81fa5-1cec-4d40-ad17-d08ce49c238b.html,,,,,, "1-Dodecanamine, reaction products with 1,1'-methylenebis[4-isocyanatobenzene] and 1-octanamine",1312943-21-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d4829bf-bec4-4832-897d-a6996f293beb/documents/10863561-7751-4965-a066-9780a1ef443f_54d81fa5-1cec-4d40-ad17-d08ce49c238b.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1-Dodecanamine, reaction products with 1,1'-methylenebis[4-isocyanatobenzene] and 1-octanamine",1312943-21-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d4829bf-bec4-4832-897d-a6996f293beb/documents/10863561-7751-4965-a066-9780a1ef443f_54d81fa5-1cec-4d40-ad17-d08ce49c238b.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1-Dodecene, dimer with 1-decene, hydrogenated",151006-58-5,"Three read-across 28-day oral exposure studies (OECD 407) and three 90-day oral exposure studies (OECD 408/OECD 415) were identified either within category or from a structural analogue. There were no key dermal or inhalation repeated dose studies identified.Overall, the 28-day exposure studies found no toxicity when the respective poly alpha olefins were administered orally. Results were as follows.• The NOAEL is 6245 mg/kg/day in male rats and 6771 mg/kg/day in female rats for the 28-day oral repeated dose study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1-dodecene dimer with 1-decene, hydrogenated.• The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1 -dodecene, trimer.For the 90-day oral exposure studies, results were as follows.• The NOAEL is 4145.4 mg/kg bw in male rats and 4619.9 mg/kg bw in female rats for the 90-day exposure study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg bw in male and female rats for the 91-day exposure study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg bw in male and female rats for the 90-day one-generation reproduction study with subchronic toxicity from 1 -dodecene, trimer. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06e43262-170b-4fdf-8a68-612009423aac/documents/99e8738b-e983-416f-a736-01b102ebd53d_6843dd80-0eb1-43a8-b430-5041b84bffdb.html,,,,,, "1-Dodecene, dimer with 1-decene, hydrogenated",151006-58-5,"One key acute oral toxicity studies (16 CFR 1500) and one key acute dermal toxicity study (OECD 402) were identified. Additional read-across studies were identified for numerous poly alpha olefins that showed similar acute oral and dermal toxicity results. Eight key acute inhalation studies (OECD 403) were identified for poly alpha olefins; four of which were for dec-1-ene, dimers, hydrogenated. • The oral LD50 was > 5000 mg/kg bw in male and female rats for dec-1-ene, dimers, hydrogenated; 1-dodecene dimer with 1-decene, hydrogenated; 1-decene trimer, hydrogenated and tetramers; 1-decene, homopolymer, hydrogenated; 1 -dodecene, trimer; and 1 -dodcene, polymer with 1 -decene.• The oral LD50 was > 2000 mg/kg bw in male and female rats for decene trimer hydrogenated.• The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for dec-1-ene, dimers, hydrogenated.• The dermal LD50 was > 2000 mg/kg/bw in male and female rats for both 1 -dodecene dimer with 1 -decene, hydrogenated; 1 -dodecene dimer with 1 -decene, hydrogenated;1 -dodecene, trimer; and 1 -dodecene, polymer with 1 -decene. • The inhalation LC50 values for dec-1 -ene, dimers, hydrogenated in male and female rats were all reported as < 5.0 mg/L.• Dec-1-ene, dimers, hydrogenated is classified for aspiration toxicity based on its kinematic viscosity at 40°C. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06e43262-170b-4fdf-8a68-612009423aac/documents/52bb3c38-3146-45ac-ae60-fd9d5f38ea66_6843dd80-0eb1-43a8-b430-5041b84bffdb.html,,,,,, "1-Dodecene, dimers",62132-67-6," Four read-across 28-day oral exposure studies (OECD 407/422) and three 90-day oral exposure studies (OECD 408/OECD 415) were identified either within category or from a structural analogue. There were no key dermal or inhalation repeated dose studies identified. Overall, the 28-day exposure studies found no toxicity when the respective poly alpha olefins were administered orally. Results were as follows. ·    The NOAEL is 6245 mg/kg/day in male rats and 6771 mg/kg/day in female rats for the 28-day oral repeated dose study from 1-decene, homopolymer, hydrogenated. ·    The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1-dodecene dimer with 1-decene, hydrogenated. ·    The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1 -dodecene, trimer. ·    The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1-dodecene, dimer. For the 90-day oral exposure studies, results were as follows. • The NOAEL is 4145.4 mg/kg bw in male rats and 4619.9 mg/kg bw in female rats for the 90-day exposure study from 1-decene, homopolymer, hydrogenated. • The NOAEL is 1000 mg/kg bw in male and female rats for the 91-day exposure study from 1-decene, homopolymer, hydrogenated. • The NOAEL is 1000 mg/kg bw in male and female rats for the 90-day one-generation reproduction study with subchronic toxicity from 1 -dodecene, trimer. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3dd01fb0-f8a6-4fd4-b8b8-6545cfa0fe80/documents/99e8738b-e983-416f-a736-01b102ebd53d_d2e96746-19ca-437c-b5d6-8c0c2413991b.html,,,,,, "1-Dodecene, dimers",62132-67-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3dd01fb0-f8a6-4fd4-b8b8-6545cfa0fe80/documents/99e8738b-e983-416f-a736-01b102ebd53d_d2e96746-19ca-437c-b5d6-8c0c2413991b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1-Dodecene, dimers",62132-67-6,"One key acute oral toxicity studies (16 CFR 1500) and one key acute dermal toxicity study (OECD 402) were identified. Additional read-across studies were identified for numerous poly alpha olefins that showed similar acute oral and dermal toxicity results. Eight key acute inhalation studies (OECD 403) were identified for poly alpha olefins; four of which were for dec-1-ene, dimers, hydrogenated. • The oral LD50 was > 5000 mg/kg bw in male and female rats for dec-1-ene, dimers, hydrogenated; 1-dodecene dimer with 1-decene, hydrogenated; 1-decene trimer, hydrogenated and tetramers; 1-decene, homopolymer, hydrogenated; 1 -dodecene, trimer; and 1 -dodcene, polymer with 1 -decene.• The oral LD50 was > 2000 mg/kg bw in male and female rats for decene trimer hydrogenated.• The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for dec-1-ene, dimers, hydrogenated.• The dermal LD50 was > 2000 mg/kg/bw in male and female rats for both 1 -dodecene dimer with 1 -decene, hydrogenated; 1 -dodecene dimer with 1 -decene, hydrogenated;1 -dodecene, trimer; and 1 -dodecene, polymer with 1 -decene. • The inhalation LC50 values for dec-1 -ene, dimers, hydrogenated in male and female rats were all reported as < 5.0 mg/L.• Dec-1-ene, dimers, hydrogenated is classified for aspiration toxicity based on its kinematic viscosity at 40°C. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3dd01fb0-f8a6-4fd4-b8b8-6545cfa0fe80/documents/52bb3c38-3146-45ac-ae60-fd9d5f38ea66_d2e96746-19ca-437c-b5d6-8c0c2413991b.html,,,,,, "1-Dodecene, homopolymer, hydrogenated",151006-63-2,"Twelve, 28-day oral exposure studies (OECD 407/422) and three 90-day oral exposure studies (OECD 408/OECD 415) were identified either within category or from a structural analogue. There were no key dermal or inhalation repeated dose studies identified.   Overall, the 28-day exposure studies found no toxicity when the respective poly alpha olefins were administered orally. Results were as follows.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dec-1-ene, dimers.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dec-1-ene, trimers, hydrogenated.   The NOAEL is 6245 mg/kg/day in male rats and 6771 mg/kg/day in female rats for the 28-day oral repeated dose study from dec-1-ene, homopolymer, hydrogenated.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dodec-1-ene, dimers.   The NOEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from dodec-1-ene, dimer, hydrogenated. The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dodec-1-ene, dimers, hydrogenated.   The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from dodec-1-ene, trimer, hydrogenated.   The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from dodec-1-ene, dimer with dec-1-ene, hydrogenated.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested dodec-1-ene, homopolymer, hydrogenated.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested tetradec-1-ene, dimers, hydrogenated.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested Alkene, polymer with 1-dodecene, distn. Residues, hydrogenated, C24-56 fraction.   The NOAEL was determined to be ≥1000 mg/kg/day in male and female rats in a Guideline OECD 422 study that tested tetradec-1-ene, polymer with dod-1-ecene, distn. residues, hydrogenated, C36-84 fraction.   For the 90-day oral exposure studies, results were as follows.   The NOAEL is 4159.4 mg/kg bw in male rats and 4619.9 mg/kg bw in female rats for the 90-day exposure study from dec-1-ene, homopolymer, hydrogenated.   The NOAEL is 1000 mg/kg bw in male and female rats for the 91-day exposure study from dec-1-ene, homopolymer, hydrogenated.   The NOAEL is 1000 mg/kg bw in male and female rats for the 90-day one-generation reproduction study with sub-chronic toxicity from dodec-1-ene, trimer, hydrogenated. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Twelve key short-term and three key sub-chronic toxicity studies available for assessment. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/facc3885-7a17-4165-8d72-4bdece9e1dbb/documents/0401d2bc-c4cf-4c33-aeec-5ffef98fc32f_b8f82b76-4a6a-418b-bf21-6d0f126656b6.html,,,,,, "1-Dodecene, homopolymer, hydrogenated",151006-63-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/facc3885-7a17-4165-8d72-4bdece9e1dbb/documents/0401d2bc-c4cf-4c33-aeec-5ffef98fc32f_b8f82b76-4a6a-418b-bf21-6d0f126656b6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1-Dodecene, homopolymer, hydrogenated",151006-63-2,"Eight key acute oral toxicity studies (OECD 401 and OECD 420) and five key acute dermal toxicity studies (OECD 402) were identified for numerous poly alpha olefins that showed similar acute oral and dermal toxicity results.   Eight key acute inhalation studies (OECD 403) were identified for poly alpha olefins.   Acute Oral   The oral LD50 was determined to be > 5000 mg/kg bw in male and female rats for dec-1-ene, dimers, hydrogenated; dec-1-ene, homopolymer, hydrogenated; dec-1-ene, tetramer, mixed with dec-1-ene, trimer, hydrogenated; dodec-1-ene, dimer, hydrogenated; dodec-1-ene, dimer with dec-1-ene, hydrogenated; dodec-1-ene, trimer, hydrogenated; and dodec-1-ene, polymer with dec-1-ene.   The oral LD50 was determined to be >2000 mg/kg bw in male and female rats for dec-1-ene, trimers, hydrogenated.   Acute Inhalation   The inhalation LC50 value for oct-1-ene, dimer, hydrogenated in male and female rats was reported to be >1.05 – <2.09 mg/L.   The inhalation LC50 values for dec-1-ene, dimers, hydrogenated in male and female rats were all reported as < 5.0 mg/L.   The inhalation LC50 value for dec-1-ene, homopolymer, hydrogenated in male and female rats was reported to be >5.2 mg/L.   The inhalation LC50 value for dodec-1-ene, dimers, hydrogenated in male rats was reported to be >5.06 mg/L while that for female rats was reported to be 1.71 mg/L.   The inhalation LC50 value for dodec-1-ene, trimers, hydrogenated in male and female rats was reported to be >5.06 mg/L.   The inhalation LC50 value for dodec-1-ene, polymer with dec-1-ene, hydrogenated in male and female rats was reported to be >5.0 mg/L.   Acute Dermal   The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for dec-1-ene, dimers, hydrogenated.   The dermal LD50 was > 2000 mg/kg/bw in male and female rats for dec-1-ene and dodec-1-ene, homopolymer; dodec-1-ene, dimers, hydrogenated; dodec-1-ene, trimers, hydrogenated; and dodec-1-ene, dimer with dec-1-ene, hydrogenated. Dodec-1-ene, homopolymer, hydrogenated is not classified for aspiration toxicity based on its kinematic viscosity of 25.3-44.3 mm2/s at 40°C. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/facc3885-7a17-4165-8d72-4bdece9e1dbb/documents/fa65d859-909d-49b5-9949-5a5dbce7ebf7_b8f82b76-4a6a-418b-bf21-6d0f126656b6.html,,,,,, "1-Dodecene, homopolymer, hydrogenated",151006-63-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/facc3885-7a17-4165-8d72-4bdece9e1dbb/documents/fa65d859-909d-49b5-9949-5a5dbce7ebf7_b8f82b76-4a6a-418b-bf21-6d0f126656b6.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1-Dodecene, homopolymer, hydrogenated",151006-63-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/facc3885-7a17-4165-8d72-4bdece9e1dbb/documents/fa65d859-909d-49b5-9949-5a5dbce7ebf7_b8f82b76-4a6a-418b-bf21-6d0f126656b6.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1-Dodecene, homopolymer, hydrogenated",151006-63-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/facc3885-7a17-4165-8d72-4bdece9e1dbb/documents/fa65d859-909d-49b5-9949-5a5dbce7ebf7_b8f82b76-4a6a-418b-bf21-6d0f126656b6.html,,inhalation,LC50,> 5 mg/L,no adverse effect observed, "Reaction products of 1-decene, 1-dodecene and 1-octene, hydrogenated",163149-28-8,"Three read-across 28-day oral exposure studies (OECD 407) and three 90-day oral exposure studies (OECD 408/OECD 415) were identified either within category or from a structural analogue. There were no key dermal or inhalation repeated dose studies identified.Overall, the 28-day exposure studies found no toxicity when the respective poly alpha olefins were administered orally. Results were as follows.• The NOAEL is 6245 mg/kg/day in male rats and 6771 mg/kg/day in female rats for the 28-day oral repeated dose study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1-dodecene dimer with 1-decene, hydrogenated.• The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from Alkane 4.For the 90-day oral exposure studies, results were as follows.• The NOAEL is 4145.4 mg/kg bw in male rats and 4619.9 mg/kg bw in female rats for the 90-day exposure study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg bw in male and female rats for the 91-day exposure study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg bw in male and female rats for the 90-day one-generation reproduction study with subchronic toxicity from Alkane 4.Overall, these results demonstrate an absence of toxicologically-relevant systemic effects, and no DNELs will therefore be derived. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a561808b-cb45-450e-a5d9-43f3e2199c84/documents/IUC5-95db198a-7861-4c14-b4a7-056c125ada72_e220a3ef-b57d-471a-86bc-9e834f5de94d.html,,,,,, "Reaction products of 1-decene, 1-dodecene and 1-octene, hydrogenated",163149-28-8,"Several key acute oral toxicity studies (16 CFR 1500; OECD 401; OECD 420; OECD 423) and key acute dermal toxicity studies (OECD 402) were identified for poly alpha olefins or structural analogues. Eight acute inhalation studies were identified for poly alpha olefins.• The oral LD50 was > 5000 mg/kg bw in male and female rats for dec-1-ene, dimers, hydrogenated; 1-dodecene dimer with 1-decene, hydrogenated; 1-decene trimer, hydrogenated and tetramers; 1-decene, homopolymer, hydrogenated; Alkane 4; and Alkane 5.• The oral LD50 was > 2000 mg/kg bw in male and female rats for decene trimer hydrogenated.• The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for dec-1-ene, dimers, hydrogenated.• The dermal LD50 was > 2000 mg/kg/bw in male and female rats for both 1-dodecene dimer with 1-decene, hydrogenated; 1-dodecene dimer with 1-decene, hydrogenated; Alkane 4; and Alkane 5.• 1-Dodecene, polymer with 1-decene and 1-octene, hydrogenated is not classified as an acute inhalation hazard based on the read-across LC50 value for Alkane 5, a structural analogue for 1-dodecene polymer with 1-decene, hydrogenated.• 1-Dodecene, polymer with 1-decene and 1-octene, hydrogenated is classified as an aspiration hazard based on read-across viscosity data from 1-dodecene polymer with 1-decene, hydrogenated at 40°C. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a561808b-cb45-450e-a5d9-43f3e2199c84/documents/IUC5-85a643e6-e38a-4b71-894d-be55cfffb35f_e220a3ef-b57d-471a-86bc-9e834f5de94d.html,,,,,, "1-Dodecene, polymer with 1-decene, hydrogenated",151006-60-9,"Three read-across 28-day oral exposure studies (OECD 407) and three 90-day oral exposure studies (OECD 408/OECD 415) were identified either within category or from a structural analogue. There were no key dermal or inhalation repeated dose studies identified.Overall, the 28-day exposure studies found no toxicity when the respective poly alpha olefins were administered orally. Results were as follows.• The NOAEL is 6245 mg/kg/day in male rats and 6771 mg/kg/day in female rats for the 28-day oral repeated dose study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1-dodecene dimer with 1-decene, hydrogenated.• The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1 -dodecene, trimer.For the 90-day oral exposure studies, results were as follows.• The NOAEL is 4145.4 mg/kg bw in male rats and 4619.9 mg/kg bw in female rats for the 90-day exposure study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg bw in male and female rats for the 91-day exposure study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg bw in male and female rats for the 90-day one-generation reproduction study with subchronic toxicity from 1 -dodecene, trimer. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67d0b1ee-cea3-4954-afec-4ddf88ef7340/documents/99e8738b-e983-416f-a736-01b102ebd53d_af061c39-4b1b-4a75-bbc3-c7069fd2f56a.html,,,,,, "1-Dodecene, polymer with 1-decene, hydrogenated",151006-60-9,"One key acute oral toxicity studies (16 CFR 1500) and one key acute dermal toxicity study (OECD 402) were identified. Additional read-across studies were identified for numerous poly alpha olefins that showed similar acute oral and dermal toxicity results. Eight key acute inhalation studies (OECD 403) were identified for poly alpha olefins; four of which were for dec-1-ene, dimers, hydrogenated. • The oral LD50 was > 5000 mg/kg bw in male and female rats for dec-1-ene, dimers, hydrogenated; 1-dodecene dimer with 1-decene, hydrogenated; 1-decene trimer, hydrogenated and tetramers; 1-decene, homopolymer, hydrogenated; 1 -dodecene, trimer; and 1 -dodcene, polymer with 1 -decene.• The oral LD50 was > 2000 mg/kg bw in male and female rats for decene trimer hydrogenated.• The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for dec-1-ene, dimers, hydrogenated.• The dermal LD50 was > 2000 mg/kg/bw in male and female rats for both 1 -dodecene dimer with 1 -decene, hydrogenated; 1 -dodecene dimer with 1 -decene, hydrogenated;1 -dodecene, trimer; and 1 -dodecene, polymer with 1 -decene. • The inhalation LC50 values for dec-1 -ene, dimers, hydrogenated in male and female rats were all reported as < 5.0 mg/L.• Dec-1-ene, dimers, hydrogenated is classified for aspiration toxicity based on its kinematic viscosity at 40°C. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67d0b1ee-cea3-4954-afec-4ddf88ef7340/documents/52bb3c38-3146-45ac-ae60-fd9d5f38ea66_af061c39-4b1b-4a75-bbc3-c7069fd2f56a.html,,,,,, 1-dodecyl-1H-imidazole,4303-67-7,An acute oral toxicity study was conducted on Laurylimidazole. The result of the study was: The rat oral LD50 is 641 mg/kg when tested according to ANSI/ADA Doc No. 41A. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a15ca6e-6d12-45e1-a29c-922af6cc0ebd/documents/IUC5-4b1e5cd3-9bb8-418d-81bd-568bd67b7fa7_6cbe9cbe-59e6-4ee4-8884-b7b1febb750c.html,,,,,, 1-ethoxy-2-(2-methoxyethoxy)ethane,1002-67-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): K1 quality data, prepared according to OECD guidelines in accordance with GLP ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d54444f-4596-4bd6-9b78-aea118da9d0b/documents/IUC5-d321be01-e767-4dc1-ab8d-16385224e277_96aaa549-0a40-414e-b20a-d842165c0984.html,,,,,, 1-ethoxy-2-(2-methoxyethoxy)ethane,1002-67-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d54444f-4596-4bd6-9b78-aea118da9d0b/documents/IUC5-d321be01-e767-4dc1-ab8d-16385224e277_96aaa549-0a40-414e-b20a-d842165c0984.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 1-ethoxy-2-(2-methoxyethoxy)ethane,1002-67-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Study performed in accordance with OECD test guidelines in compliance with GLP using the most recent test guideline. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Study performed in accordance with OECD test guidelines in compliance with GLP using the most recent test guideline. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d54444f-4596-4bd6-9b78-aea118da9d0b/documents/IUC5-d1b39c95-58ab-43ce-8116-613d4537d5e8_96aaa549-0a40-414e-b20a-d842165c0984.html,,,,,, 1-ethoxy-2-(2-methoxyethoxy)ethane,1002-67-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d54444f-4596-4bd6-9b78-aea118da9d0b/documents/IUC5-d1b39c95-58ab-43ce-8116-613d4537d5e8_96aaa549-0a40-414e-b20a-d842165c0984.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-ethoxy-2-(2-methoxyethoxy)ethane,1002-67-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d54444f-4596-4bd6-9b78-aea118da9d0b/documents/IUC5-d1b39c95-58ab-43ce-8116-613d4537d5e8_96aaa549-0a40-414e-b20a-d842165c0984.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-Ethoxy-2,3-difluor-4-[4-(trans-4-propylcyclohexyl)-1-cyclohexen-1-yl]-benzene",124728-62-7,"In a repeated dose oral toxicity study combined with a reproduction/developmental toxicity screening study with rats (OECD 422), adverse histopatological effects were observed in the thyroid gland of females at 300 and 1000 mg/kg bw/day. Therefore parental NOAEL was established to be at least 100 mg/kg bw/day based on the effects in the thyroid gland. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5abc111a-0fe5-42d1-b587-af124c29bca4/documents/1e67b55f-bb95-4ad8-80a4-32828dca6f72_7cabb866-e29a-4243-8967-3098acdaeb28.html,,,,,, "1-Ethoxy-2,3-difluor-4-[4-(trans-4-propylcyclohexyl)-1-cyclohexen-1-yl]-benzene",124728-62-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5abc111a-0fe5-42d1-b587-af124c29bca4/documents/1e67b55f-bb95-4ad8-80a4-32828dca6f72_7cabb866-e29a-4243-8967-3098acdaeb28.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1-Ethoxy-2,3-difluor-4-[4-(trans-4-propylcyclohexyl)-1-cyclohexen-1-yl]-benzene",124728-62-7,The test material has no acute toxic potential and the LD50 value is higher than 2000 mg/kg after single oral administration in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5abc111a-0fe5-42d1-b587-af124c29bca4/documents/3be26465-2370-496b-a8c2-8c865ba1c24b_7cabb866-e29a-4243-8967-3098acdaeb28.html,,,,,, "1-Ethoxy-2,3-difluor-4-[4-(trans-4-propylcyclohexyl)-1-cyclohexen-1-yl]-benzene",124728-62-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5abc111a-0fe5-42d1-b587-af124c29bca4/documents/3be26465-2370-496b-a8c2-8c865ba1c24b_7cabb866-e29a-4243-8967-3098acdaeb28.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1-Ethoxy-2,3-difluoro-4-(trans-4-pentylcyclohexyl)-benzene",124729-02-8,For the oral route of administration a read across to a reliable GLP study that was performed according OECD TG 423 is provided. The LD50 exceeds 2000 mg/kg bw/day. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9229d8ec-3a0d-41d9-9746-1915a9385c5f/documents/IUC5-2abbe9ed-8e8c-482a-90bd-7662c630301d_df678902-61c8-4f75-adca-db10467a5342.html,,,,,, "1-Ethoxy-2,3-difluoro-4-(trans-4-pentylcyclohexyl)-benzene",124729-02-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9229d8ec-3a0d-41d9-9746-1915a9385c5f/documents/IUC5-2abbe9ed-8e8c-482a-90bd-7662c630301d_df678902-61c8-4f75-adca-db10467a5342.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-Ethoxy-2,3-difluor-4-(trans-4-propylcyclohexyl)-benzene",174350-05-1,The NOAEL (no observed adverse effect level) after repeated oral exposure in rats was established at 450 mg/kg bw/d and the NOEL (no observed effect level) was considered to be 50 mg/kg bw/d. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98f91b62-5ca9-4bb1-900a-b5c3181a6e49/documents/cb074004-6d84-44c1-b8e9-440e44aa502e_a8b13111-5ab8-4e6a-8761-d01684a86946.html,,,,,, "1-Ethoxy-2,3-difluor-4-(trans-4-propylcyclohexyl)-benzene",174350-05-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98f91b62-5ca9-4bb1-900a-b5c3181a6e49/documents/cb074004-6d84-44c1-b8e9-440e44aa502e_a8b13111-5ab8-4e6a-8761-d01684a86946.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat "1-Ethoxy-2,3-difluor-4-(trans-4-propylcyclohexyl)-benzene",174350-05-1,The test material has no acute toxic potential and the LD50 value is higher than 2000 mg/kg bw after single oral administration in male/female rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98f91b62-5ca9-4bb1-900a-b5c3181a6e49/documents/IUC5-114f7010-1755-447d-ad23-0670ba144475_a8b13111-5ab8-4e6a-8761-d01684a86946.html,,,,,, "1-Ethoxy-2,3-difluor-4-(trans-4-propylcyclohexyl)-benzene",174350-05-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98f91b62-5ca9-4bb1-900a-b5c3181a6e49/documents/IUC5-114f7010-1755-447d-ad23-0670ba144475_a8b13111-5ab8-4e6a-8761-d01684a86946.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1-Ethoxy-2,3-difluoro-4-[4-(trans-4-pentylcyclohexyl)-1-cyclohexene-1-yl]-benzene",570384-43-9,"Based on the result of this study, it is concluded that the read-across source substance has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg after single oral administration in rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36ca9d76-f1cc-4c7a-a973-973716cd8bc5/documents/cf99011e-0a32-4e3b-aa9c-e80b20c13982_d0631b7c-ffc3-406a-b7a9-42cbf5395c1a.html,,,,,, "1-Ethoxy-2,3-difluoro-4-[4-(trans-4-pentylcyclohexyl)-1-cyclohexene-1-yl]-benzene",570384-43-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36ca9d76-f1cc-4c7a-a973-973716cd8bc5/documents/cf99011e-0a32-4e3b-aa9c-e80b20c13982_d0631b7c-ffc3-406a-b7a9-42cbf5395c1a.html,,dermal,LD50,">=2,000 mg/kg bw",no adverse effect observed, "1-ethoxy-2,3-difluoro-4-[trans-4-(trans-4-pentylcyclohexyl)-cyclohexyl-benzene",124728-81-0,The read-across substance has no acute toxic potential and the LD50 value is higher than 2000 mg/kg bw after single oral administration in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b5f7e6e-bddf-4b86-ac4c-0a2f7762cdfa/documents/6caf3c52-90b8-4f20-a6f9-3ab88dd8f609_ebe54a0c-4ec5-40ba-8124-1d919f703a52.html,,,,,, "1-ethoxy-2,3-difluoro-4-[trans-4-(trans-4-pentylcyclohexyl)-cyclohexyl-benzene",124728-81-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b5f7e6e-bddf-4b86-ac4c-0a2f7762cdfa/documents/6caf3c52-90b8-4f20-a6f9-3ab88dd8f609_ebe54a0c-4ec5-40ba-8124-1d919f703a52.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1-Ethoxy-2,3-difluoro-4-[trans-4-(trans-4-propylcyclohexyl)-cyclohexyl]-benzene",123560-48-5,"For the read-across source substance toxicity after repeated oral administration was investigated in two experimental studies: a subacute toxicity study with oral treatment of rats with doses of 1000, 200, and 40 mg/kg bw/d for 28 days and a 14 -day treatment-free recovery period according to OECD 407; and a combined repeat dose reproduction screening study with oral treatment of rats with doses of 135, 45 and 15 mg/kg bw/d for 42 days (males) and up to 49 days (females). The lowest NOAEL systemic was 15 mg/kg bw/d. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/834d3349-edde-4dcb-af27-2ef9e506100c/documents/8a1a8130-d10c-4719-8c6b-b53c53e68e04_627fc4ac-171e-4e9c-a9d9-c9102fbba305.html,,,,,, "1-Ethoxy-2,3-difluoro-4-[trans-4-(trans-4-propylcyclohexyl)-cyclohexyl]-benzene",123560-48-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/834d3349-edde-4dcb-af27-2ef9e506100c/documents/8a1a8130-d10c-4719-8c6b-b53c53e68e04_627fc4ac-171e-4e9c-a9d9-c9102fbba305.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "1-Ethoxy-2,3-difluoro-4-[trans-4-(trans-4-propylcyclohexyl)-cyclohexyl]-benzene",123560-48-5,The test material has no acute toxic potential and the LD50 value is higher than 2000 mg/kg bw after single oral administration in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/834d3349-edde-4dcb-af27-2ef9e506100c/documents/4c6458cf-1dc4-4ac1-b617-4e85ee48d14e_627fc4ac-171e-4e9c-a9d9-c9102fbba305.html,,,,,, "1-Ethoxy-2,3-difluoro-4-[trans-4-(trans-4-propylcyclohexyl)-cyclohexyl]-benzene",123560-48-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/834d3349-edde-4dcb-af27-2ef9e506100c/documents/4c6458cf-1dc4-4ac1-b617-4e85ee48d14e_627fc4ac-171e-4e9c-a9d9-c9102fbba305.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1-ethoxy-2,3-difluorobenzene",121219-07-6," Oral administration of the test item to Wistar rats at doses of 1000 mg/kg bw/day, for 28 days resulted in salivation and piloerection, hunched posture (females only), reduced locomotor activity, reduced body weight development (males only), changes in clinical biochemistry parameters commensurate with effects upon lipid metabolism and increased metabolic activity in the liver, higher liver weights and hepatocellular hypertrophy. All other parameters and all other dose groups were unaffected by the treatment with the test article. Hepatocellular hypertrophy was also noted in a few male rats treated with 100 mg/kg bw/day and 300 mg/kg bw/day. The cause of death in the single female which died (1000 mg/kg/day) could not be established. A NOEL could not be established. However, in the absence of commensurate changes in the clinical biochemistry parameters, liver hypertrophy noted in a few males treated with 100 mg/kg bw/day or 300 mg/kg bw/day was considered to be indicative of metabolic adaptation. The NOAEL was considered to be 300 mg/kg body weight/day following treatment with the substance (reference 7.5.1 -1). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b21f96c-6e31-484a-8850-0a0086cbe6e2/documents/2f5a149e-0084-4e42-8f61-b6561c4cc720_53e124dd-5cdf-421d-a84e-1b59b4adc0be.html,,,,,, "1-ethoxy-2,3-difluorobenzene",121219-07-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b21f96c-6e31-484a-8850-0a0086cbe6e2/documents/2f5a149e-0084-4e42-8f61-b6561c4cc720_53e124dd-5cdf-421d-a84e-1b59b4adc0be.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "1-ethoxy-2,3-difluorobenzene",121219-07-6," Oral (OECD TG 401), rat: LD50 between 1000 and 2000 mg/kg bw (reference 7.2.1 -1) Dermal (OECD TG 402), rat: LD50 > 2000 mg/kg bw (reference 7.2.3 -1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b21f96c-6e31-484a-8850-0a0086cbe6e2/documents/d8de47b5-c5d2-4080-9dfc-38f30d4cffd5_53e124dd-5cdf-421d-a84e-1b59b4adc0be.html,,,,,, "1-ethoxy-2,3-difluorobenzene",121219-07-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b21f96c-6e31-484a-8850-0a0086cbe6e2/documents/d8de47b5-c5d2-4080-9dfc-38f30d4cffd5_53e124dd-5cdf-421d-a84e-1b59b4adc0be.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, "1-ethoxy-2,3-difluorobenzene",121219-07-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b21f96c-6e31-484a-8850-0a0086cbe6e2/documents/d8de47b5-c5d2-4080-9dfc-38f30d4cffd5_53e124dd-5cdf-421d-a84e-1b59b4adc0be.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 1-ethoxypropan-2-ol,1569-02-4,Surrogate substance (ethoxypropoxypropanol) Oral: NOAEL (90 day) >1000mg/kgInhalation: NOAEC (9 day) >1.4mg/L. NOAEC (90 day)=1.266mg/LSurrogate substance (methoxypropanol) Dermal: NOAEL(21 day)~2080mg/kg ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d16eb7f4-c4b6-4003-91aa-0b2020a798bf/documents/IUC5-1bc61e2a-943d-4a3d-bdd4-fee9a19c26f6_176aee82-6878-4397-a346-dc238d396f1b.html,,,,,, 1-ethoxypropan-2-ol,1569-02-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d16eb7f4-c4b6-4003-91aa-0b2020a798bf/documents/IUC5-1bc61e2a-943d-4a3d-bdd4-fee9a19c26f6_176aee82-6878-4397-a346-dc238d396f1b.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,840 mg/kg bw/day",,rabbit 1-ethoxypropan-2-ol,1569-02-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d16eb7f4-c4b6-4003-91aa-0b2020a798bf/documents/IUC5-1bc61e2a-943d-4a3d-bdd4-fee9a19c26f6_176aee82-6878-4397-a346-dc238d396f1b.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,266 mg/m3",,rat 1-ethoxypropan-2-ol,1569-02-4," LD0 (oral) > 1792 mg/kg (>2mls/kg) LC0 (inhalation, 4 hrs) > 9.59 mg/L (represents approximately 22% of saturated vapour pressure.) (analogue) methoxypropanol LD50 (dermal) >2000mg/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d16eb7f4-c4b6-4003-91aa-0b2020a798bf/documents/cfb73fc6-351c-44a2-a0b9-ce541f836c7a_176aee82-6878-4397-a346-dc238d396f1b.html,,,,,, 1-ethyl-2-(3-methylbutyl)cyclopentanol,1465004-85-6, The substance was tested in a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test. Based on the absence of adverse effects the NOAEL was determined to be 4500 mg/kg diet for male and female rats (equivalent to an overall intake of at least 265 mg/kg bw/d in males and at least 328 mg/kg bw/d in females). ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e3d3ab9-74ed-42ba-83ac-881ea2f5aa25/documents/04184b8d-a218-4452-ac41-4b28ab7eaf00_42052cc3-6a25-45c7-a2ec-11493e4ea824.html,,,,,, 1-ethyl-2-(3-methylbutyl)cyclopentanol,1465004-85-6,"The acute oral toxicity of the test substance, Fret 10-0367 was assessed according to OECD Test Guideline 420 using a fixed dose method. The LD50 was estimated to be greater than 2000 mg/kg body weight.   The acute dermal toxicity of the test substance, Fret 10-0367 was assessed according to OECD Test Guideline 402. The LD50 was greater than 2000 mg/kg body weight.   The acute inhalation toxicity of the test substance, Fret 10-0367 was assessed according to OECD Test Guideline 403. The 4 hour LC50 was greater than 4.97 mg/L, the mean achieved atmosphere concentration. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Good Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Good Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Good ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e3d3ab9-74ed-42ba-83ac-881ea2f5aa25/documents/0b8ea471-1348-4dce-a396-d6a4ef184fb1_42052cc3-6a25-45c7-a2ec-11493e4ea824.html,,,,,, 1-ethyl-2-(3-methylbutyl)cyclopentanol,1465004-85-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e3d3ab9-74ed-42ba-83ac-881ea2f5aa25/documents/0b8ea471-1348-4dce-a396-d6a4ef184fb1_42052cc3-6a25-45c7-a2ec-11493e4ea824.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-ethyl-2-(3-methylbutyl)cyclopentanol,1465004-85-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e3d3ab9-74ed-42ba-83ac-881ea2f5aa25/documents/0b8ea471-1348-4dce-a396-d6a4ef184fb1_42052cc3-6a25-45c7-a2ec-11493e4ea824.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-ethyl-2-(3-methylbutyl)cyclopentanol,1465004-85-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e3d3ab9-74ed-42ba-83ac-881ea2f5aa25/documents/0b8ea471-1348-4dce-a396-d6a4ef184fb1_42052cc3-6a25-45c7-a2ec-11493e4ea824.html,,inhalation,LC50,> 4.97 mg/L,no adverse effect observed, 1-Ethyl-3-methylimidazolium dicyanamide,370865-89-7," No systemic treatement-related, adverse effects were observed in rats after oral exposure at all concentrations. The NOAEL was 339.0 mg/kg bw/day in males and 476.0 mg/kg bw/day in females. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3242f60-fb9c-4072-9c48-34665484286f/documents/e3216593-d581-4741-be50-06e3f253945d_896e2204-ffe3-42e7-9b71-68b9ee23fc3b.html,,,,,, 1-Ethyl-3-methylimidazolium dicyanamide,370865-89-7, The LD50 through oral exposure was >2000 mg/kg bw in a GLP-compliant OECD 423 study. The LD50 through dermal exposure was >2000 mg/kg bw in a GLP-compliant OECD 402 study. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3242f60-fb9c-4072-9c48-34665484286f/documents/db556a71-ad78-45f0-a534-280b130c57e6_896e2204-ffe3-42e7-9b71-68b9ee23fc3b.html,,,,,, 1-Ethyl-3-methylimidazolium dicyanamide,370865-89-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3242f60-fb9c-4072-9c48-34665484286f/documents/db556a71-ad78-45f0-a534-280b130c57e6_896e2204-ffe3-42e7-9b71-68b9ee23fc3b.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 1-Ethyl-3-methylimidazolium dicyanamide,370865-89-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3242f60-fb9c-4072-9c48-34665484286f/documents/db556a71-ad78-45f0-a534-280b130c57e6_896e2204-ffe3-42e7-9b71-68b9ee23fc3b.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 1-Ethyl-3-methylimidazolium benzoate,150999-33-0," LD50 (oral, rat) > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/431c1152-992c-474a-ab0c-632a03b92ba7/documents/1eefb4a8-277b-4b43-a0a1-d7d8908258a6_a5542e2e-2476-487f-9e09-ba56b6cb6572.html,,,,,, 1-Ethyl-3-methylimidazolium benzoate,150999-33-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/431c1152-992c-474a-ab0c-632a03b92ba7/documents/1eefb4a8-277b-4b43-a0a1-d7d8908258a6_a5542e2e-2476-487f-9e09-ba56b6cb6572.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 1-ethylazepan-2-one,19797-08-1," Oral (OECD 422), male rat: NOAEL = 50 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51b6fc72-aa50-4f45-b4c5-e2e58d84e554/documents/b0bcf7d1-14a4-41c8-853c-f6bedcca70f3_8545ad2b-0ba5-4074-9f8b-6694dee4b053.html,,,,,, 1-ethylazepan-2-one,19797-08-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51b6fc72-aa50-4f45-b4c5-e2e58d84e554/documents/b0bcf7d1-14a4-41c8-853c-f6bedcca70f3_8545ad2b-0ba5-4074-9f8b-6694dee4b053.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 1-ethylazepan-2-one,19797-08-1," Oral (OECD 423), rat: LD50 > 300 mg/kg bw < 2000 mg/kg bw Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw Inhalation (OECD 403), rat: LC50 > 1 mg/L air < 5 mg/L air ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51b6fc72-aa50-4f45-b4c5-e2e58d84e554/documents/caf9e8e7-87be-4b0a-9ebb-0c798b2310f0_8545ad2b-0ba5-4074-9f8b-6694dee4b053.html,,,,,, 1-ethylazepan-2-one,19797-08-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51b6fc72-aa50-4f45-b4c5-e2e58d84e554/documents/caf9e8e7-87be-4b0a-9ebb-0c798b2310f0_8545ad2b-0ba5-4074-9f8b-6694dee4b053.html,,oral,LD50,300 mg/kg bw,adverse effect observed, 1-ethylazepan-2-one,19797-08-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51b6fc72-aa50-4f45-b4c5-e2e58d84e554/documents/caf9e8e7-87be-4b0a-9ebb-0c798b2310f0_8545ad2b-0ba5-4074-9f8b-6694dee4b053.html,,inhalation,LC50,1 mg/m3,adverse effect observed, 1-ethylpiperidine,766-09-6,"Repeated dose toxicity: oral Key: NOAEL (systemic toxicity) > 80 mg/kg bw (highest tested dose), NOAEL (local effects, males) = 20 mg/kg bw based on slight inflammation with keratolysis in the forestomach, NOAEL (local effects, females) = 80 mg/kg bw, rat, sub-acute (28 days), according to OECD 407, GLP-compliant, 2006, K1   Repeated dose toxicity: inhalation Key: Read-across to CAS 110-89-4: NOAEC (systemic toxicity) > 350 mg/m3 air, (highest tested dose), NOAEC (local effects) = 70 mg/m3 air based on bloody nasal discharge and reddish crusts around the nose, rat, sub-acute (28 days), according to OECD 412, GLP-compliant, 1993, K1 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6837d869-3ec4-48d6-8f89-61a78ba0b0a0/documents/IUC5-2557935a-7fa1-4eb8-a999-ac53ffbcfb41_a4b644fc-58c2-4459-aadd-32724f69a412.html,,,,,, 1-ethylpiperidine,766-09-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6837d869-3ec4-48d6-8f89-61a78ba0b0a0/documents/IUC5-2557935a-7fa1-4eb8-a999-ac53ffbcfb41_a4b644fc-58c2-4459-aadd-32724f69a412.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,> 80 mg/kg bw/day,,rat 1-ethylpiperidine,766-09-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6837d869-3ec4-48d6-8f89-61a78ba0b0a0/documents/IUC5-2557935a-7fa1-4eb8-a999-ac53ffbcfb41_a4b644fc-58c2-4459-aadd-32724f69a412.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,> 350 mg/m3,,rat 1-ethylpiperidine,766-09-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6837d869-3ec4-48d6-8f89-61a78ba0b0a0/documents/IUC5-2557935a-7fa1-4eb8-a999-ac53ffbcfb41_a4b644fc-58c2-4459-aadd-32724f69a412.html,Repeated dose toxicity – local effects,inhalation,NOAEC,70 mg/m3,adverse effect observed,rat 1-ethylpiperidine,766-09-6,"Acute toxicity: oral Key: LD50 = 280 mg/kg bw, rat, similar to OECD 401, non GLP compliance, 1970, K2   Acute toxicity: inhalation Key: LC50 = 2.24 mg/L, rat, similar to OECD 403, non GLP compliance, 1987, K2   Acute toxicity: dermal Key: LD50 > 200 mg/kg bw, rabbit, similar to OECD 402, non GLP compliance, 1980, K2 Sup: Read-across to CAS 626-67-5: LD50 > 1000 mg/kg bw - < 2000 mg/kg bw, rabbit, according to guideline EPA OTS 798.1100, GLP compliant, 1994, K1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6837d869-3ec4-48d6-8f89-61a78ba0b0a0/documents/IUC5-b82a7832-0967-43bb-a651-dc9790be9784_a4b644fc-58c2-4459-aadd-32724f69a412.html,,,,,, 1-ethylpiperidine,766-09-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6837d869-3ec4-48d6-8f89-61a78ba0b0a0/documents/IUC5-b82a7832-0967-43bb-a651-dc9790be9784_a4b644fc-58c2-4459-aadd-32724f69a412.html,,oral,LD50,280 mg/kg bw,adverse effect observed, 1-ethylpiperidine,766-09-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6837d869-3ec4-48d6-8f89-61a78ba0b0a0/documents/IUC5-b82a7832-0967-43bb-a651-dc9790be9784_a4b644fc-58c2-4459-aadd-32724f69a412.html,,dermal,LD50,"< 2,000 mg/kg bw",adverse effect observed, 1-ethylpiperidine,766-09-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6837d869-3ec4-48d6-8f89-61a78ba0b0a0/documents/IUC5-b82a7832-0967-43bb-a651-dc9790be9784_a4b644fc-58c2-4459-aadd-32724f69a412.html,,inhalation,LC50,2.42 mg/m3,adverse effect observed, 1-ethynylcyclohexanol,78-27-3," The administration of 1-Ethinylcyclohexanol by gavage to male and female Wistar rats for 3 months (OECD 408) caused test substance-related, adverse signs of systemic toxicity at a dose level of 150 mg/kg bw/d taking clinical findings in female animals into account. Findings related to tubular damage in kidneys of male animals do not represent a risk for humans and were not considered relevant for the determination of the no observed adverse effect level (NOAEL). Therefore, under the conditions of the present study the NOAEL was 150 mg/kg bw/d for male and 50 mg/kg bw/d for female Wistar rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c227c3a-8e6c-4201-b608-92a604b3aab3/documents/IUC5-493916cd-33d6-46b5-8b16-9001e79d7ffc_399f38e4-51eb-4b45-a5c2-f8ac733047bb.html,,,,,, 1-ethynylcyclohexanol,78-27-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c227c3a-8e6c-4201-b608-92a604b3aab3/documents/IUC5-493916cd-33d6-46b5-8b16-9001e79d7ffc_399f38e4-51eb-4b45-a5c2-f8ac733047bb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 1-ethynylcyclohexanol,78-27-3,"The LD50 values derived from the key studies were: LD50 (oral, rat) 600 mg/kg bw and LD50 (dermal, rat) 1000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c227c3a-8e6c-4201-b608-92a604b3aab3/documents/IUC5-22e40fcb-ade1-4c2c-b8df-f359d9afba25_399f38e4-51eb-4b45-a5c2-f8ac733047bb.html,,,,,, 1-ethynylcyclohexanol,78-27-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c227c3a-8e6c-4201-b608-92a604b3aab3/documents/IUC5-22e40fcb-ade1-4c2c-b8df-f359d9afba25_399f38e4-51eb-4b45-a5c2-f8ac733047bb.html,,oral,LD50,600 mg/kg bw,adverse effect observed, 1-ethynylcyclohexanol,78-27-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c227c3a-8e6c-4201-b608-92a604b3aab3/documents/IUC5-22e40fcb-ade1-4c2c-b8df-f359d9afba25_399f38e4-51eb-4b45-a5c2-f8ac733047bb.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, 1-ethynylcyclohexyl acetate,5240-32-4,Acute oral toxicity: Based on read across information from Ambrate (similar to OECD TG 401):LD50 = 680 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/785c5f42-097e-4a28-b312-84bd92d55456/documents/d417a4c1-1fb9-480e-97f2-4d64ae2c3e03_61dbd856-920f-4909-94cf-769848fc337e.html,,,,,, 1-ethynylcyclohexyl acetate,5240-32-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/785c5f42-097e-4a28-b312-84bd92d55456/documents/d417a4c1-1fb9-480e-97f2-4d64ae2c3e03_61dbd856-920f-4909-94cf-769848fc337e.html,,oral,LD50,680 mg/kg bw,adverse effect observed, 1-fluoro-2-nitrobenzene,1493-27-2,"By analogy with 1-fluoro-4-nitrobenzene, methemoglobinemia and damages to the spleen have been observed. Oral NOAEL is 5 mg/kg and inhalation NOAEC is 13 mg/m3. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/211c1e32-be0c-4de4-995a-9622ba5c5699/documents/IUC5-094982f0-a0b6-4998-b2d9-da89589c285d_b965645a-9f98-4333-8943-2d1ccc28b325.html,,,,,, 1-fluoro-2-nitrobenzene,1493-27-2,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/211c1e32-be0c-4de4-995a-9622ba5c5699/documents/IUC5-094982f0-a0b6-4998-b2d9-da89589c285d_b965645a-9f98-4333-8943-2d1ccc28b325.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat 1-fluoro-2-nitrobenzene,1493-27-2,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/211c1e32-be0c-4de4-995a-9622ba5c5699/documents/IUC5-094982f0-a0b6-4998-b2d9-da89589c285d_b965645a-9f98-4333-8943-2d1ccc28b325.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,13 mg/m3,,rat "1H,1'H-[2,2'-biindole]-3,3'-diol",835912-68-0,There were no adverse effects noted up to the highest dose levels tested ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c7e7eaa-8cfb-4ce6-b68d-26ca88109f32/documents/IUC5-abf41238-6bf2-43b2-b107-cba3bdb97b31_e6195a72-2511-4bba-a1d3-0863a195cc8d.html,,,,,, "1H,1'H-[2,2'-biindole]-3,3'-diol",835912-68-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c7e7eaa-8cfb-4ce6-b68d-26ca88109f32/documents/IUC5-abf41238-6bf2-43b2-b107-cba3bdb97b31_e6195a72-2511-4bba-a1d3-0863a195cc8d.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat "1H,1'H-[2,2'-biindole]-3,3'-diol",835912-68-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c7e7eaa-8cfb-4ce6-b68d-26ca88109f32/documents/IUC5-abf41238-6bf2-43b2-b107-cba3bdb97b31_e6195a72-2511-4bba-a1d3-0863a195cc8d.html,Chronic toxicity – systemic effects,dermal,NOAEL,25 mg/kg bw/day,,mouse "1H,1'H-[2,2'-biindole]-3,3'-diol",835912-68-0,Vat Indigo Potassium Salt is only stable in aqueous alkaline solutions to prevent the Leuco-Lndigo from oxidising to Indigo (pH >11.5). The registered substance oxidizes in the presence of water and air-borne oxygen within 5-15 minutes to Indigo (CAS-No. 482-89-3) and potassium hydroxide (100 g Produkt 1998 result in 33 g KOH). Due to the given corrosive effect of 30% KOH testing for acute toxicity of the alkaline solution is not possible. There is however sufficient data on indigo and leucoindigo showing that those substances are practically nontoxic any effects observed in preparations were due to the contained alkali fraction. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c7e7eaa-8cfb-4ce6-b68d-26ca88109f32/documents/IUC5-fa789623-1547-48f2-8e58-38c4a22dc05f_e6195a72-2511-4bba-a1d3-0863a195cc8d.html,,,,,, "1H,1'H-[2,2'-biindole]-3,3'-diol",835912-68-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c7e7eaa-8cfb-4ce6-b68d-26ca88109f32/documents/IUC5-fa789623-1547-48f2-8e58-38c4a22dc05f_e6195a72-2511-4bba-a1d3-0863a195cc8d.html,,oral,LD50,"4,430 mg/kg bw",no adverse effect observed, "1H,1'H-[2,2'-biindole]-3,3'-diol",835912-68-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c7e7eaa-8cfb-4ce6-b68d-26ca88109f32/documents/IUC5-fa789623-1547-48f2-8e58-38c4a22dc05f_e6195a72-2511-4bba-a1d3-0863a195cc8d.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, "1H,1'H-[2,2'-biindole]-3,3'-diol",835912-68-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c7e7eaa-8cfb-4ce6-b68d-26ca88109f32/documents/IUC5-fa789623-1547-48f2-8e58-38c4a22dc05f_e6195a72-2511-4bba-a1d3-0863a195cc8d.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "ethyl 1-(2,6-difluorobenzyl)-1H-1,2,3-triazole-4-carboxylate",869501-51-9,No reliable data are available. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1edf28f-798c-4a27-8fbf-2856d14ab606/documents/IUC5-20cc7a0f-27bf-4cfe-a271-fc871ca9f6bc_6f5ffacd-893a-44ad-9e1f-aad42dab4234.html,,,,,, "1H-1,2,4-triazole, sodium salt",41253-21-8,"LD0 (oral) >1000 mg/kg bw (Dufour 1992 (1), OECD guideline study ).LD50 (oral) <2000 mg/kg bw (Dufour 1992 (2), OECD guideline study ).LD0 (dermal) > 2000 mg/kg bw (Ollivier 2003, OECD guideline and GLP study). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b2daa60-e8ce-475d-8d21-731c745b9b5b/documents/IUC5-9ea12fb9-dc37-4498-af3f-80797968a08b_cb53f185-15d8-465f-8a45-9598ab17e19d.html,,,,,, "1H-1,2,4-triazole, sodium salt",41253-21-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b2daa60-e8ce-475d-8d21-731c745b9b5b/documents/IUC5-9ea12fb9-dc37-4498-af3f-80797968a08b_cb53f185-15d8-465f-8a45-9598ab17e19d.html,,oral,LD50,"> 1,000 mg/kg bw",adverse effect observed, "1H-1,2,4-triazole, sodium salt",41253-21-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b2daa60-e8ce-475d-8d21-731c745b9b5b/documents/IUC5-9ea12fb9-dc37-4498-af3f-80797968a08b_cb53f185-15d8-465f-8a45-9598ab17e19d.html,,dermal,LD0,"> 2,000 mg/kg bw",no adverse effect observed, 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7-carboxylic acid,139481-59-7,No clinical signs and no abnormalities in body weight and body weight gain were observed. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/096d9cad-4bcb-4acc-8ed9-5335294ca6bb/documents/IUC5-8642468e-2ddd-4fed-a71f-ebbffefbead8_2ae5049a-d498-4f36-82f4-7ca7db8ec2c0.html,,,,,, 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7-carboxylic acid,139481-59-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/096d9cad-4bcb-4acc-8ed9-5335294ca6bb/documents/IUC5-8642468e-2ddd-4fed-a71f-ebbffefbead8_2ae5049a-d498-4f36-82f4-7ca7db8ec2c0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"2,000 mg/kg bw/day",,rat 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7-carboxylic acid,139481-59-7,"Under the experimental conditions adopted, oral administration of the test substance at a dose of 2000 mg/kg caused no mortality and did not require enthanasia during 14-day periods, in the female Sprague-Dawley Rat: LD50 (oral) is higher than 2000 mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/096d9cad-4bcb-4acc-8ed9-5335294ca6bb/documents/IUC5-e53c7705-2b1a-4d0b-99ad-42053ec0c156_2ae5049a-d498-4f36-82f4-7ca7db8ec2c0.html,,,,,, 2-ethoxy-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-benzimidazole-7-carboxylic acid,139481-59-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/096d9cad-4bcb-4acc-8ed9-5335294ca6bb/documents/IUC5-e53c7705-2b1a-4d0b-99ad-42053ec0c156_2ae5049a-d498-4f36-82f4-7ca7db8ec2c0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. residues",68609-68-7,"From the results of tis study it is concluded that the NOAEL for female Wistar rats after repeated administration of the registration substance for 90 consecutive days is 750 mg/kg body weight per day, the highest dose tested. At this dose level in female animals no significant clinical or systemic toxic findings occurred and no histopathological liver lesions were detected. Observed thyroid gland findings are considered to be of secondary nature. In males, due to the observed kidney lesions, no NOAEL could be established under the conditions of this study. However, the nature of kidney lesions was shown to be hyaline inclusions consisting of α2μ-Globulin, a male rat-specific event and therefore without toxicological relevance to humans. Therefore, no signs of toxicological relevance for humans were demonstrated also in male animals up to a dose of 750 mg/kg body weight per day. The absence of relevant and/or significant systemic toxicity of the registration substance is supported by the results of a subacute oral toxicity study according to OECD TG 422 which revealed a NOAEL of 1000 mg/kg body weight per day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f1b6c62-ece0-4f15-bff4-44fb48ac0788/documents/IUC5-f1539cf9-c6f4-46a4-9821-07e1117bd87b_7bb4caf9-9d1b-4216-98c3-d76683388c57.html,,,,,, "1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. residues",68609-68-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f1b6c62-ece0-4f15-bff4-44fb48ac0788/documents/IUC5-f1539cf9-c6f4-46a4-9821-07e1117bd87b_7bb4caf9-9d1b-4216-98c3-d76683388c57.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. residues",68609-68-7,"The LD50/LC50 values derived from the key limit studies in male and female rats were >5000 mg/kg bw and >5400 mg/m³ for oral and inhalation exposure, respectively. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f1b6c62-ece0-4f15-bff4-44fb48ac0788/documents/IUC5-52290675-1131-4df2-84ba-90961e1e79fc_7bb4caf9-9d1b-4216-98c3-d76683388c57.html,,,,,, "1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. residues",68609-68-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f1b6c62-ece0-4f15-bff4-44fb48ac0788/documents/IUC5-52290675-1131-4df2-84ba-90961e1e79fc_7bb4caf9-9d1b-4216-98c3-d76683388c57.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "1-Hexanol, 2-ethyl-, manuf. of, by-products from, distn. residues",68609-68-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f1b6c62-ece0-4f15-bff4-44fb48ac0788/documents/IUC5-52290675-1131-4df2-84ba-90961e1e79fc_7bb4caf9-9d1b-4216-98c3-d76683388c57.html,,inhalation,LC50,"5,400 mg/m3",no adverse effect observed, "3,3,4,4,5,5,6,6-octafluoro-6-iodohex-1-ene",203929-12-8,"A repeat dose inhalation toxicity study was conducted on IOFH. The result of the study was: The No Observed Adverse Effect Concentration (NOAEC) was 55 ppm (0.79 mg/L, vapor) when tested according to OECD 412. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba316f0e-2073-46d4-a6af-35d2de8b0247/documents/IUC5-1f5988a1-ff68-4bb3-b714-9b698f5842fb_cd311277-b49f-4727-80f9-15890c61ff28.html,,,,,, "3,3,4,4,5,5,6,6-octafluoro-6-iodohex-1-ene",203929-12-8,"An acute inhalation toxicity was conducted on IOFH. The result of the study was:The rat inhalation LC50 is greater than 431.5 ppm (6.25 mg/L, vapor) when tested according to OECD 403. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba316f0e-2073-46d4-a6af-35d2de8b0247/documents/IUC5-0ef95635-9235-49d5-9f46-34ac4a315296_cd311277-b49f-4727-80f9-15890c61ff28.html,,,,,, Imidazole-1-propionitrile(8CI);1-(2-Cyanoethyl)imidazole,23996-53-4,"Oral (Acute Toxic Class Method), rat: LD50 = 500 - 2000 mg/kg bw; reliability score = 1; BASF SE 1998 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99373d3f-1bc6-4bca-ac39-76615588a193/documents/IUC5-77068beb-4c83-448b-b334-a437850c6d39_802b3002-d1b0-4d8b-83b4-967fe86a37ff.html,,,,,, 1H-imidazole-1-propylamine,5036-48-6," N-(3-Aminopropyl)-imidazol was tested in an oral 90 -d study in rats (OECD408, 2019) with a NOAEL of 300 mg/kg bw/d. An oral 28-d study in rats (OECD 407, 1999) was also performed with a NOAEL of 200 mg/kg bw/d. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2610778f-bd50-4597-8a72-15bf0139af07/documents/IUC5-be8cf054-f566-4500-86cf-6a77fd47c5ca_e6710751-6b97-427f-b474-5773461ddf2e.html,,,,,, 1H-imidazole-1-propylamine,5036-48-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2610778f-bd50-4597-8a72-15bf0139af07/documents/IUC5-be8cf054-f566-4500-86cf-6a77fd47c5ca_e6710751-6b97-427f-b474-5773461ddf2e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat 1H-imidazole-1-propylamine,5036-48-6," The acute oral LD50 was 1780 mg/kg in rats. Studies of acute dermal and inhalative toxicity of 1H-imidazole-1-propylamien are not available. According to the REACh regulation, annex VII+VIII, 8.5 column 2, a acute dermal and inhalative study does not need to be conducted due to the corrosivity of 1H-imidazole-1-propylamien are not available. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2610778f-bd50-4597-8a72-15bf0139af07/documents/IUC5-f60d10c6-caf6-4e61-8943-013d045041a0_e6710751-6b97-427f-b474-5773461ddf2e.html,,,,,, 1H-imidazole-1-propylamine,5036-48-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2610778f-bd50-4597-8a72-15bf0139af07/documents/IUC5-f60d10c6-caf6-4e61-8943-013d045041a0_e6710751-6b97-427f-b474-5773461ddf2e.html,,oral,LD50,"1,780 mg/kg bw",adverse effect observed, 5-chloro-4-(4-methylphenyl)-1H-imidazole-2-carbonitrile,120118-14-1,No data available. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d6658c82-e08e-4f54-8b43-18d0d3b5e156/documents/IUC5-2bf02ff0-eb60-4cf9-98a0-6d59d0a13293_ebed1d85-f7ae-42aa-b1ba-c5b30173db1c.html,,,,,, "Lithium 4,5-dicyano-2-(trifluoromethyl)imidazolate",761441-54-7,"A combined screening for toxicity to reproduction with short-term repeated-dose toxicity study via the oral was conducted on the registered substance. Dose selection was based on the outcome of 14-day Dose Range Finding study. Based on the results of this study, the NOAEL for the general toxicity was 25 mg/kg/day for males and 10 mg/kg/day for females. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study was GLP-compliant and conducted according to a relevant OECD Testing Guideline. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/abfdc048-1b06-4a4d-af04-c958936ffbb9/documents/6d39865b-7823-4be7-ad01-5a7f566861f1_a0fc3e52-b1e1-40f0-ad08-b91c2a04f911.html,,,,,, "Lithium 4,5-dicyano-2-(trifluoromethyl)imidazolate",761441-54-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/abfdc048-1b06-4a4d-af04-c958936ffbb9/documents/6d39865b-7823-4be7-ad01-5a7f566861f1_a0fc3e52-b1e1-40f0-ad08-b91c2a04f911.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "Lithium 4,5-dicyano-2-(trifluoromethyl)imidazolate",761441-54-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Key study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Key study ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abfdc048-1b06-4a4d-af04-c958936ffbb9/documents/IUC5-0d79da5d-3d71-4f03-840d-5af98e625e72_a0fc3e52-b1e1-40f0-ad08-b91c2a04f911.html,,,,,, "Lithium 4,5-dicyano-2-(trifluoromethyl)imidazolate",761441-54-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abfdc048-1b06-4a4d-af04-c958936ffbb9/documents/IUC5-0d79da5d-3d71-4f03-840d-5af98e625e72_a0fc3e52-b1e1-40f0-ad08-b91c2a04f911.html,,oral,discriminating dose,50 mg/kg bw,adverse effect observed, "1H-Imidazolium, 1,3-diethyl-, acetate (1:1)",1040916-84-4,Acute oral: LD50(rat): > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb21dfc9-ab96-4d3d-9bd3-c158885b3299/documents/08f933e3-9b7d-4496-b2d6-25559d5bdc9d_739d4c32-252d-4892-96f2-cf133623083b.html,,,,,, 1-Ethyl-3-methylimidazolium trifluoromethanesulfonate,145022-44-2,"oral: The median lethal dose (LD50) of 1 H-lmidazolium, 3-ethyl-1-methyl-, trifluoromethanesulfonate after oral administration was found to be greater than 2000 mg/kg bw in rats. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27618b29-f8e7-4592-ab26-7d4b3d96fe3f/documents/IUC5-eec90131-a225-4efa-8bff-7d36f5188612_97602ad1-fa3e-474f-85fa-04e595356c08.html,,,,,, 1-Ethyl-3-methylimidazolium trifluoromethanesulfonate,145022-44-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27618b29-f8e7-4592-ab26-7d4b3d96fe3f/documents/IUC5-eec90131-a225-4efa-8bff-7d36f5188612_97602ad1-fa3e-474f-85fa-04e595356c08.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 3-ethyl-1-methyl-1H-Imidazolium chloride (1:1),65039-09-0,"LD50 (oral, rat): >300 - < 2000 mg/kg bw (BASF, 2006)LD50 (dermal, rat): > 2000 mg/kg (BASF, 2006) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d43bb4a-1cd3-423f-9199-912554d240ba/documents/IUC5-a17d77a4-c097-44b4-a509-e3f9e55fe487_6cc0145e-ee44-48e8-b66a-3d3fc900ddc8.html,,,,,, 3-ethyl-1-methyl-1H-Imidazolium chloride (1:1),65039-09-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d43bb4a-1cd3-423f-9199-912554d240ba/documents/IUC5-a17d77a4-c097-44b4-a509-e3f9e55fe487_6cc0145e-ee44-48e8-b66a-3d3fc900ddc8.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 3-Ethyl-1-methyl-1H-imidazolium methanesulfonate (1:1),145022-45-3,oral: The median lethal dose (LD50) of EMIM Methansulfonat after oral administration was found to be greater than 2000 mg/kg bw in rats. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c523ffd-0674-4974-8fc5-277a72cce480/documents/IUC5-57f2a5c3-51e1-4475-9424-53d7aa2f248e_7db2448f-bde1-4890-918b-1f42740c00d5.html,,,,,, "Reaction mass of (1R,2R)-, (1R,2S)- (1S,2R)- and (1S,2S)-Isomers of 2,3-dihydro-2,6-dimethyl-1H-inden-1-amine",1225478-65-8," The oral LD50 value determined in the rat was between 300 and 2000 mg/kg bw (read across, CAS 752984-24-0). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e43e658-6d8c-4cee-9a00-074c03f2b643/documents/82d47fa1-cf54-42f6-8c16-5daddc33bf0a_f91e5abb-d998-4c83-9842-eb587ff3afb1.html,,,,,, "2,3-Dihydro-2,6-dimethyl-1H-inden-1-one",66309-83-9,"Oral (Rat, according to OECD TG 423): LD50 >2000 mg/kg Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35a8fc6b-0f70-45ff-aec8-de38193b0946/documents/6a1b536f-a324-4240-bce0-d1bfbeeaa587_c9664c90-a398-457c-ab96-ed18f0267098.html,,,,,, "2,3-Dihydro-2,6-dimethyl-1H-inden-1-one",66309-83-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35a8fc6b-0f70-45ff-aec8-de38193b0946/documents/6a1b536f-a324-4240-bce0-d1bfbeeaa587_c9664c90-a398-457c-ab96-ed18f0267098.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1-[(difluoromethyl)sulfonyl]-3-(4,6-dimethoxy-1,3,5-triazin-2-yl)-7-fluoro-1H-indol-2-ol",1383692-20-3,"Acute toxicity: oral (rats, OECD TG 423): LD50: > 2000 mg/kg b.w.The acute oral toxicity to female Wistar rats of the test item was assessed. The test compound was formulated in tap water with the aid of PEG 400, the administration volume was 10 mL/kg body weight. The starting dose of the test item was 2000 mg/kg bw. According to the OECD guideline 423 the LD50 of the test item is > 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14852579-4d97-458b-978b-b3b263e0b4df/documents/927575a9-4ce4-41e6-ae0b-ae09165a4a7b_9cea5dd0-4a90-4b8a-af75-d2c6fa7492d9.html,,,,,, "1-[(difluoromethyl)sulfonyl]-3-(4,6-dimethoxy-1,3,5-triazin-2-yl)-7-fluoro-1H-indol-2-ol",1383692-20-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14852579-4d97-458b-978b-b3b263e0b4df/documents/927575a9-4ce4-41e6-ae0b-ae09165a4a7b_9cea5dd0-4a90-4b8a-af75-d2c6fa7492d9.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, (tert-Butoxycarbonyl)methyl 2-[1-[(4-chlorophenyl)carbonyl]-5-methoxy-2-methylindol-3-yl]acetate,75302-98-6,"Oral (Rat-Wistar, GLP-like): LD50 males = 67 mg/kg, LD50 females = > 25 < 50 mg/kg; LD50 both sexes approx. 36 mg/kg[Bayer AG, Report No. 18004, 1989-05-16]Dermal (Rat-Wistar, GLP-like): LD50 males = 1451 mg/kg, LD50 females = > 100 < 500 mg/kg; LD50 both sexes 918 mg/kg[Bayer AG, Report No. 15809, 1987-05-22]A further non-GLP, non-Guideline study was conducted in male Wistar rats with a single oral administration of 108 mg/kg TVX 3934 (equivalent to Acemetacin-tert.-butylester) by gavage. TVX 3934 was suspended in Traganth (application volume 5 ml/kg) or Lutrol (application volume 10 ml/kg) and 10 animals per solvent were used. No animal died after administration of TVX 3934 in Traganth and one animal died after administration of TVX 3934 in Lutrol. No LD50 could be defined in this study.[Troponwerke, Scientific Report No. 51138 F, 1987-03-23] ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5892e78-1de9-41cc-9b39-2d957af15965/documents/IUC5-f3cd3bda-d53e-414c-b0b5-e3cdb1a08422_b0f9a210-9c4e-43ce-b43b-26d7c674e5a1.html,,,,,, (tert-Butoxycarbonyl)methyl 2-[1-[(4-chlorophenyl)carbonyl]-5-methoxy-2-methylindol-3-yl]acetate,75302-98-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5892e78-1de9-41cc-9b39-2d957af15965/documents/IUC5-f3cd3bda-d53e-414c-b0b5-e3cdb1a08422_b0f9a210-9c4e-43ce-b43b-26d7c674e5a1.html,,oral,LD50,36 mg/kg bw,, (tert-Butoxycarbonyl)methyl 2-[1-[(4-chlorophenyl)carbonyl]-5-methoxy-2-methylindol-3-yl]acetate,75302-98-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5892e78-1de9-41cc-9b39-2d957af15965/documents/IUC5-f3cd3bda-d53e-414c-b0b5-e3cdb1a08422_b0f9a210-9c4e-43ce-b43b-26d7c674e5a1.html,,dermal,LD50,918 mg/kg bw,, "1H-Isoindol-1-one, 2,3-dihydro-3,3-bis(4-hydroxyphenyl)-2-phenyl-",6607-41-6,"A 28-day oral (gavage) toxicity study was performed (2005) in rats in accordance with OECD 407, and included a functional observational battery and determination of motor activity. The study was GLP compliant (OECD). Doses of the test substance employed were 0 (control), 100, 300 and 1000 mg/kg/day.No clear evidence of toxicity to the test substance was noted in this study and the NOAEL was considered to be > 1000 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc415c0d-8ef6-40d0-9ced-465708c27c53/documents/IUC5-a2f7e8a1-0f0e-49b4-bbcc-547e1ba6c2c0_54f2e390-3953-4b62-b1a2-ffb2ed146846.html,,,,,, "1H-Isoindol-1-one, 2,3-dihydro-3,3-bis(4-hydroxyphenyl)-2-phenyl-",6607-41-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc415c0d-8ef6-40d0-9ced-465708c27c53/documents/IUC5-a2f7e8a1-0f0e-49b4-bbcc-547e1ba6c2c0_54f2e390-3953-4b62-b1a2-ffb2ed146846.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1H-Isoindol-1-one, 2,3-dihydro-3,3-bis(4-hydroxyphenyl)-2-phenyl-",6607-41-6,An acute oral toxicity study was performed (2004) in female rats in accordance with OECD 425 (up-and-down procedure). The study was GLP compliant (OECD/EPA). The oral LD50 was > 2000 mg/kg bw. An acute dermal toxicity study was performed (2004) in male and female rabbits in accordance with OECD 402. The study was GLP compliant (OECD/EPA). The dermal LD50 was > 2000 mg/kg bw.An acute inhalation toxicity study in rodents was not performed as acute oral and dermal toxicity studies fulfill this endpoint. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc415c0d-8ef6-40d0-9ced-465708c27c53/documents/IUC5-b3ad76fe-7d53-40bc-9d67-b19da31cf070_54f2e390-3953-4b62-b1a2-ffb2ed146846.html,,,,,, "1H-Isoindol-1-one, 2,3-dihydro-3,3-bis(4-hydroxyphenyl)-2-phenyl-",6607-41-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc415c0d-8ef6-40d0-9ced-465708c27c53/documents/IUC5-b3ad76fe-7d53-40bc-9d67-b19da31cf070_54f2e390-3953-4b62-b1a2-ffb2ed146846.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1H-Isoindol-1-one, 2,3-dihydro-3,3-bis(4-hydroxyphenyl)-2-phenyl-",6607-41-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc415c0d-8ef6-40d0-9ced-465708c27c53/documents/IUC5-b3ad76fe-7d53-40bc-9d67-b19da31cf070_54f2e390-3953-4b62-b1a2-ffb2ed146846.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-[(2R)-2-hydroxy-3-{[4-(3-oxomorpholin-4-yl)phenyl]amino}propyl]-1H-isoindole-1,3(2H)-dione",446292-07-5,"Oral (Rat-Wistar, GLP, OECD TG 423, EU Method B. 1 tris, EPA OPPTS 870.1100): LD50 > 2000 mg/kg [Bayer AG, Report No. PH-34728, 2007-01-12] Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/757c806b-9755-49ca-b4a8-0d773e2e9ed7/documents/IUC5-2d46cd9e-7f3a-4f45-898d-7c771512309c_1be52616-3e80-487a-91a6-bf427a68a3b8.html,,,,,, "2-[(2R)-2-hydroxy-3-{[4-(3-oxomorpholin-4-yl)phenyl]amino}propyl]-1H-isoindole-1,3(2H)-dione",446292-07-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/757c806b-9755-49ca-b4a8-0d773e2e9ed7/documents/IUC5-2d46cd9e-7f3a-4f45-898d-7c771512309c_1be52616-3e80-487a-91a6-bf427a68a3b8.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2-[(2S)-oxiran-2-ylmethyl]-1H-isoindole-1,3(2H)-dione",161596-47-0,"Acute toxicity: oral (rats, OECD TG 423): LD50: > 2000 mg/kg b.w. The acute oral toxicity to female Wistar rats of the test item was assessed. The test compound was formulated in tap water with the aid of 2 % Cremophor EL, the administration volume was 10 mL/kg body weight. The starting dose of the test item was 2000 mg/kg bw. According to the OECD guideline 423 the LD50 of the test item is > 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60a436f0-ccfa-4854-a65d-c3f3c8aa5c20/documents/508f71cf-c029-4542-9b33-7ccaa892c0ce_bfea44ee-6cde-448f-9b0c-e1e981febda6.html,,,,,, "2-[(2S)-oxiran-2-ylmethyl]-1H-isoindole-1,3(2H)-dione",161596-47-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60a436f0-ccfa-4854-a65d-c3f3c8aa5c20/documents/508f71cf-c029-4542-9b33-7ccaa892c0ce_bfea44ee-6cde-448f-9b0c-e1e981febda6.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2-[[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]methyl]isoindole-1,3-dione",446292-08-6,"Oral (Rat-Wistar, GLP, OECD TG 423, EU Method B. 1 tris, EPA OPPTS 870.1100): LD50 > 2000 mg/kg [Bayer AG, Report No. PH-34455, 2006-05-19]   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47f7246e-758e-4280-b948-8afc22c5a50e/documents/IUC5-61f0f18c-f441-4660-9424-9f2761480168_4e36e9f1-4975-4b88-a632-59616aaf5f1c.html,,,,,, "2-[[(5S)-2-oxo-3-[4-(3-oxomorpholin-4-yl)phenyl]-1,3-oxazolidin-5-yl]methyl]isoindole-1,3-dione",446292-08-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47f7246e-758e-4280-b948-8afc22c5a50e/documents/IUC5-61f0f18c-f441-4660-9424-9f2761480168_4e36e9f1-4975-4b88-a632-59616aaf5f1c.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1,4-Dimethyl-1H-pyrazole",1072-68-0,"Acute oral LD50: 859 mg/kg bw (Nissan Chemical Industries, 1994) ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b878b0b1-58db-457f-9b82-96804baac5f5/documents/IUC5-963bcebf-193a-4117-9388-bf2c580f5e43_6cfeede8-0e91-4acc-bc57-66de8a8559bc.html,,,,,, "1,4-Dimethyl-1H-pyrazole",1072-68-0,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b878b0b1-58db-457f-9b82-96804baac5f5/documents/IUC5-963bcebf-193a-4117-9388-bf2c580f5e43_6cfeede8-0e91-4acc-bc57-66de8a8559bc.html,,oral,LD50,859 mg/kg bw,adverse effect observed, "1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs.",71077-14-0," Acute oral toxicity: Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs (CAS no.: 71077-14-0). The studies are as mentioned below: 1. The acute oral toxicity study was designed and conducted for test chemical in wistar albino female rats according to the OECD Guideline-423. The healthy wistar albino rats of body weight 200±20 gm were selected for study after acclimatization to standard laboratory condition and divided into test compound and vehicle control group each having three animals. Initially, the test compound was mixed with distilled water and administered orally at the dose level of 2000 mg/kg body weight (dose volume 10ml/kg) to three female rats. However; vehicle control group treated with distilled water at the dose level of 10 ml/kg b.wt. The treated animals were closely observed for clinical signs of intoxication during first 4 hours of test compound administration. Thereafter, all the animals were observed periodically at 1 hour interval for 24 hrs and twice daily for a period of 14 days. The necropsy was performed on all animals at the termination of the study. The test compound did not produce any mortality at the dose level of 2000 mg/kg body weight during the entire observation period. Animals did not produce any clinical signs of toxicity during the entire observation period. Animals showed normal gain in body weight on day 7th and 14th as compared to control group. No significant gross pathological changes related to compound toxicity were observed. Skin and hair coat was observed wet. It was concluded that the test compound is non-toxic at the tested dose level 2000 mg/kg body weight. According to criteria of CLP, it comes under the “Category Not classified"". 2. Acute oral toxicity test was conducted in male Sprague-Dawley white mice using test chemical at the dose concentration of 1250 mg/kg, 2500 mg/kg, 3750 mg/kg 5000 mg/kg, 6250 mg/kg to 6 animals per dose by oral route. Control animals received distilled water only. The mice were observed for 3 days for the signs and symptoms of toxicity as well as the death rate of each group were recorded. Test material administration at single dose has not been found to be any toxic effects even at higher dose used (6250 mg/Kg BW) at the same time there is no mortality or morbidity was recorded in all grouped animals. Hence, LD50 was considered to be >6250 mg/kg bw when male Sprague- Dawley white mice was treated with test chemical for 3 days via oral route. Thus, based on the above summarised studies, 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs (CAS no.: 71077-14-0) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs (CAS no.: 71077-14-0) cannot be classified for acute oral toxicity. Hence, based on the data available for the structurally similar read across chemical, 1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs is not likely to be toxic in the dose range of >2000 - >6250 mg/Kg bw. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4ba98a2-4ba2-4be1-b8d6-18433a29bf71/documents/21b126ea-a1e9-4bfb-8c83-0e3f386b12af_6435e324-6fa9-4398-9f5f-0f3263ebcf80.html,,,,,, "1H-Pyrazole-3-carboxylic acid, 4,5-dihydro-5-oxo-1-(4-sulfophenyl)-4-[(4-sulfophenyl)azo]-, reaction products with guanidine hydrochloride N,N'-bis(mixed Ph, tolyl and xylyl) derivs.",71077-14-0,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4ba98a2-4ba2-4be1-b8d6-18433a29bf71/documents/21b126ea-a1e9-4bfb-8c83-0e3f386b12af_6435e324-6fa9-4398-9f5f-0f3263ebcf80.html,,oral,LD50,"6,250 mg/kg bw",no adverse effect observed, ethyl 5-amino-1-(2-fluorobenzyl)-1H-pyrazole-3-carboxylate,256504-39-9,"Acute toxicity: oral (rats, OECD TG 423): LD50: > 2000 mg/kg bw The study was performed to asses the acute oral toxicity of the test item in female WI rats according to the OECD guideline 423.The single oral administration of the test substance to the rats at a dose of 2000 mg/kg bw was tolerated without any mortality or compound-related clinical or macroscopic pathological signs. The LD50 acute oral toxicity in female WI rats was estimated to be above 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/deaf2181-d2cb-4839-97d5-720005f1a250/documents/9ce2b0f1-98b0-4b3b-a90e-9035e6399b9b_19b03c5f-d10f-4750-8609-9eae3002b070.html,,,,,, ethyl 5-amino-1-(2-fluorobenzyl)-1H-pyrazole-3-carboxylate,256504-39-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/deaf2181-d2cb-4839-97d5-720005f1a250/documents/9ce2b0f1-98b0-4b3b-a90e-9035e6399b9b_19b03c5f-d10f-4750-8609-9eae3002b070.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 3-(difluoromethyl)-1-methyl-1 H-pyrazole-4-carbonyl chloride,141573-96-8,"Read-across is applied from the free acid 3-difluoromethyl-1-methylpyrazole-4-carboxylic (CAS 176969-34-9) as source to the substance 3-(difluoromethyl)-1-methyl-1 H-pyrazole-4-carbonyl chloride (CAS 141573-96-8) for acute oral toxicity: Oral (Rat, according to OECD TG 423): LD50 <2000 mg/kg   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9f1a325-0de3-413f-ac37-1afb34e9180d/documents/afcf2936-0677-41cd-8e0c-993fc3b39e04_6c914bbd-7af2-4c61-8e27-e8394019e992.html,,,,,, 3-(difluoromethyl)-1-methyl-1 H-pyrazole-4-carbonyl chloride,141573-96-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9f1a325-0de3-413f-ac37-1afb34e9180d/documents/afcf2936-0677-41cd-8e0c-993fc3b39e04_6c914bbd-7af2-4c61-8e27-e8394019e992.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 4-[2-Ethoxy-5-(4-methyl-1-piperazinylsulfonyl)benzamido]-1-3-propyl-1H-pyrazole-5-carboxamide,200575-15-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c1b0632-2266-4552-848f-d27ce5d40340/documents/b65ebba8-e219-4db4-8b9c-cd8bb20c7c45_2d937f4b-da18-4a94-867b-12ddfed439c7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 1-(3-chloropyridin-2-yl)-3-{[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxylic acid,1352319-02-8,"  Repeated dose oral toxicity in vivo (rat, 28 days, OECD TG 407): NOAEL ≥ 1000 mg/kg bw/day In this study SD rats were used to conduct repeated dose 28-day oral toxicity testing of the test item, to investigate the main toxic effects produced in rats, to determine the maximum no-effect dose, and as far as was possible, determine affected organs, to provide data for sub-chronic and chronic toxicity test dose selection and observation endpoints.The test design included four groups, the doses were 0, 100, 300  and 1000 mg/kg bw/day and the application frequency was once a day.After the conclusion of the recovery period observation, the surviving animals underwent necropsy. Throughout the entire test process, clinical observation, body weight, food intake, haematological indications, blood clotting parameters, serum biochemical indicators, urine routine, neurological function tests, gross necropsy, organ weight, and histopathology tests were conducted on the rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8737e594-f39a-4251-a6cf-c6d39cd3fcd1/documents/cc6fe752-2c07-44e5-a76e-75840bdb08d3_21e0128d-e85a-4fce-a276-37c987b88340.html,,,,,, 1-(3-chloropyridin-2-yl)-3-{[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxylic acid,1352319-02-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8737e594-f39a-4251-a6cf-c6d39cd3fcd1/documents/cc6fe752-2c07-44e5-a76e-75840bdb08d3_21e0128d-e85a-4fce-a276-37c987b88340.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"> 1,000 mg/kg bw/day",,rat 1-(3-chloropyridin-2-yl)-3-{[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxylic acid,1352319-02-8,"Acute toxicity: oral (rats, OECD TG 423): LD50: > 2000 mg/kg bw The acute oral toxicity to female Wistar rats of the test item was assessed. The administration volume was 10 mL/kg body weight. The starting dose of the test item was 2000 mg/kg bw. According to the OECD guideline 423 the LD50 of the test item is > 2000 mg/kg bw.   Acute toxicity: inhalation (rats, OECD TG 436): LCD50, 4h: > 5045 ± 152 mg/m³ The study was designed according to OECD 436 to assess the acute inhalation toxicity of the test item after being snout-only administrated to SD rats for 4 hours and to serve as a basis for classification and labelling. Based on the results, the acute inhalation LC50 in SD rats for the test item in 4 hours exposure period is > 5045 ± 152 mg/m³.   Acute toxicity: oral (rats, OECD TG 402): LD50: > 2000 mg/kg bw The study was performed to asses the acute dermal toxicity of the test item in male and female SD rats according to the OECD guideline 402.The single dermal administration of the test substance to the rats at a dose of 2000 mg/kg bw was tolerated without any mortality or compound-related clinical or macroscopic pathological signs.The LD50 acute dermal toxicity in male and female SD rats was estimated to be > 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8737e594-f39a-4251-a6cf-c6d39cd3fcd1/documents/864d7187-1607-465f-a79c-9860ec1b0203_21e0128d-e85a-4fce-a276-37c987b88340.html,,,,,, 1-(3-chloropyridin-2-yl)-3-{[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxylic acid,1352319-02-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8737e594-f39a-4251-a6cf-c6d39cd3fcd1/documents/864d7187-1607-465f-a79c-9860ec1b0203_21e0128d-e85a-4fce-a276-37c987b88340.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 1-(3-chloropyridin-2-yl)-3-{[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxylic acid,1352319-02-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8737e594-f39a-4251-a6cf-c6d39cd3fcd1/documents/864d7187-1607-465f-a79c-9860ec1b0203_21e0128d-e85a-4fce-a276-37c987b88340.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 1-(3-chloropyridin-2-yl)-3-{[5-(trifluoromethyl)-2H-tetrazol-2-yl]methyl}-1H-pyrazole-5-carboxylic acid,1352319-02-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8737e594-f39a-4251-a6cf-c6d39cd3fcd1/documents/864d7187-1607-465f-a79c-9860ec1b0203_21e0128d-e85a-4fce-a276-37c987b88340.html,,inhalation,LC50,"> 5,045 mg/m3",no adverse effect observed, "ethyl 1-(4-methoxyphenyl)-6-(4-nitrophenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate",536759-91-8," Sprague-Dawley CD® rats (10 animals/sex/group) were dosed by oral gavage once daily with 0 (1% w/v Methylcellulose), 10, 100 or 1000 mg/kg/day of BMS-589152-01. The study was performed in compliance with OECD 422 guideline for testing of chemicals adopted 28.07.15: Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test. The male animals were dosed during the pre-cohabitation, cohabitation and post-mating periods (approximately 35 days) and then euthanized and necropsied. The female animals were dosed during the pre-cohabitation and cohabitation periods and during gestation and lactation (through Lactation Day [LD] 13, approximately 70 days) and then euthanized and necropsied. The dose volume was 5 mL/kg/day for all dose groups. Parameters evaluated during the study for the F0 animals were: viability, clinical observations, body weights, food consumption, estrous cycling, mating and fertility, parturition and littering, functional assessments, clinical pathology (at termination) and thyroid hormone analysis (at termination), organ weights, macroscopic observations and microscopic pathology. Parameters evaluated for the F1pups were: viability, clinical observations, sex, body weights, ano-genital distance, nipple retention, thyroid hormone analysis (at Postnatal Days [PND} 4 and 13), thyroid weights, macroscopic observations and microscopic pathology (thyroids). An additional 5 animals/sex in Groups 1 and 4 were dosed by oral gavage once daily for 35 days with 0 (1% w/v Methylcellulose) or 1000 mg/kg/day BMS-589152-01. At the end of the treatment period, these animals were held for a 14 day treatment-free recovery period and then euthanized and necropsied. Parameters evaluated during the study were: viability, clinical observations, body weights, food consumption, clinical pathology (hematology and clinical chemistry at end of recovery; coagulation at end of dosing and end of recovery), organ weights, macroscopic and microscopic observations. There were four unscheduled decedents (i.e., one male and two females at 1000 mg/kg/day and one female at 10 mg/kg/day) over the course of this study. Due to the absence and/or nature of the clinical signs and pathology findings, the causes of these deaths could not be unequivocally attributed to treatment with BMS-589152-01. There were no clinical signs associated with the treatment of BMS-589152-01 in males and females that survived until scheduled termination. There were no body weight or food consumption differences, organ weight, clinical pathology or thyroid hormone differences, macroscopic or microscopic changes attributed to BMS-589152-01.  There were no BMS-589152-01-related adverse effects on estrous cycling, mating and fertility indices, delivery and litter size or on litter observations. There were no BMS-589152-01-related effects on pup sex, mean body weights, anogenital distance, nipple retention, functional assessments, or macroscopic changes attributed toBMS-589152-01. With all findings considered, the male and female systemic NOAEL was 1000 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ed824b0-38d3-4d80-b293-d76db41a8188/documents/32d328e7-3eff-4023-844d-dae3549978ba_333d1b08-b2fe-4c4f-8e47-a978359bf754.html,,,,,, "ethyl 1-(4-methoxyphenyl)-6-(4-nitrophenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate",536759-91-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ed824b0-38d3-4d80-b293-d76db41a8188/documents/32d328e7-3eff-4023-844d-dae3549978ba_333d1b08-b2fe-4c4f-8e47-a978359bf754.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "ethyl 1-(4-methoxyphenyl)-6-(4-nitrophenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate",536759-91-8," A key study was completed for acute oral toxicity according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) and EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method). A key study was completed for the acute dermal toxicity according to OECD Guideline 402 (Acute Dermal Toxicity) and EU Method B.3 (Acute Toxicity (Dermal)). Both of these studies were completed under GLP. An acute inhalation study was attempted but generating a representative atmosphere of the test items as supplied was not feasible and therefore the study was not conducted. However, in view of the physical nature of the test item and its apparent low volatility it is considered unlikely to represent a significant hazard by the inhalation route. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ed824b0-38d3-4d80-b293-d76db41a8188/documents/f4cd1bcd-020a-4338-9b02-919567a50332_333d1b08-b2fe-4c4f-8e47-a978359bf754.html,,,,,, "ethyl 1-(4-methoxyphenyl)-6-(4-nitrophenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate",536759-91-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ed824b0-38d3-4d80-b293-d76db41a8188/documents/f4cd1bcd-020a-4338-9b02-919567a50332_333d1b08-b2fe-4c4f-8e47-a978359bf754.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "ethyl 1-(4-methoxyphenyl)-6-(4-nitrophenyl)-7-oxo-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate",536759-91-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ed824b0-38d3-4d80-b293-d76db41a8188/documents/f4cd1bcd-020a-4338-9b02-919567a50332_333d1b08-b2fe-4c4f-8e47-a978359bf754.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "ethyl 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxo-1-piperidinyl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate",503614-91-3," Based on a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test performed with BMS-589154-01 according to OECD guideline 422 and GLP principles, the NOAEL was determined to be at least 1000 mg/kg bw/day, based on no adverse effects at the highest concentration tested. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a2da0d0-0f62-400a-a396-ed51477993c8/documents/b0ebe71b-10d8-4ed1-bedc-45b688cf602f_1b9b2638-e5c6-45a6-b7d7-e28a865c83ac.html,,,,,, "ethyl 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxo-1-piperidinyl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate",503614-91-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a2da0d0-0f62-400a-a396-ed51477993c8/documents/b0ebe71b-10d8-4ed1-bedc-45b688cf602f_1b9b2638-e5c6-45a6-b7d7-e28a865c83ac.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "ethyl 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxo-1-piperidinyl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate",503614-91-3," The acute oral lethal dose (LD50) to rats of BMS 589154 -01 was demonstrated to be greater than 2,000 mg/kg bodyweight. Similarly, in an acute dermal toxicity study with BMS-589154-01 in rats, performed according to OECD/EC test guidelines, an LD50 >2000 mg/kg bw was determined. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a2da0d0-0f62-400a-a396-ed51477993c8/documents/14effbe9-373f-481f-b319-a92f01a8c251_1b9b2638-e5c6-45a6-b7d7-e28a865c83ac.html,,,,,, "ethyl 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxo-1-piperidinyl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate",503614-91-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a2da0d0-0f62-400a-a396-ed51477993c8/documents/14effbe9-373f-481f-b319-a92f01a8c251_1b9b2638-e5c6-45a6-b7d7-e28a865c83ac.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "ethyl 1-(4-methoxyphenyl)-7-oxo-6-(4-(2-oxo-1-piperidinyl)phenyl)-4,5,6,7-tetrahydro-1H-pyrazolo[3,4-c]pyridine-3-carboxylate",503614-91-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a2da0d0-0f62-400a-a396-ed51477993c8/documents/14effbe9-373f-481f-b319-a92f01a8c251_1b9b2638-e5c6-45a6-b7d7-e28a865c83ac.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 1-hydroxy-4-[[4-[(methylsulphonyl)oxy]phenyl]amino]anthraquinone,1594-08-7,"The No Observed Adverse Effect Level (NOAEL) for Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test by Oral Gavage in Wistar rats for FAT36038/J TE is determined to be 1000 mg/kg bw/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): High quality GLP study ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5e83e44-da48-48ab-95ff-69084bf91b4b/documents/9765d2b0-ebe0-459e-81a7-01e762e12292_4c5b292f-c053-4f9e-84fc-6b83a578f91f.html,,,,,, 1-hydroxy-4-[[4-[(methylsulphonyl)oxy]phenyl]amino]anthraquinone,1594-08-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5e83e44-da48-48ab-95ff-69084bf91b4b/documents/9765d2b0-ebe0-459e-81a7-01e762e12292_4c5b292f-c053-4f9e-84fc-6b83a578f91f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 1-hydroxy-4-[[4-[(methylsulphonyl)oxy]phenyl]amino]anthraquinone,1594-08-7,The acute oral LD50 of FAT 36038/F in rats of both sexes observed over a period of 14 days is greater than 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5e83e44-da48-48ab-95ff-69084bf91b4b/documents/IUC5-d5b2f59c-2c5f-43d1-b155-ededca380dc8_4c5b292f-c053-4f9e-84fc-6b83a578f91f.html,,,,,, 1-hydroxy-4-[[4-[(methylsulphonyl)oxy]phenyl]amino]anthraquinone,1594-08-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5e83e44-da48-48ab-95ff-69084bf91b4b/documents/IUC5-d5b2f59c-2c5f-43d1-b155-ededca380dc8_4c5b292f-c053-4f9e-84fc-6b83a578f91f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-imino-1H-isoindol-3-amine,3468-11-9," Dose range finding 14-day repeated dose toxicity via oral route A dose range finding study was performed which preceeded the presented key 28-day repeated dose study. To assess the possible health hazards which could arise from repeated exposure of the test item via oral administration to rats, the test item was administered daily to 3 groups of test animals at 5, 10 and 25 mg/kg bw/day for a treatment period of 14 days. Under the conditions of the present study, no major signs of toxicity or mortality were observed. There are no regulatory guidelines for this type of dose range-finding study, but the study design was based on the principles specified in OECD TG 407. The study was non-GLP. No NOAEL was determinded for this study as it served as a dose range finder. This study is used as supporting study. 28-day repeated dose toxicity study via oral route For this endpoint there is one key study available: a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in Wistar rats administered 5, 10, and 25 mg/kg bw/d. In this study the NOAEL for general toxicity is considered to be at least 25 mg/kg bw/day for the test item. Repeated dose toxicity via other routes There are no studies available in which the repeated dose toxicity via inhalation or dermal route is assessed. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b386e32d-9dfb-417d-a00f-aec09b68a90e/documents/decaaf70-20ed-4705-9c19-aa4f642258b8_d8fc9129-eaef-498d-a9b0-2580e6d809c5.html,,,,,, 1-imino-1H-isoindol-3-amine,3468-11-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b386e32d-9dfb-417d-a00f-aec09b68a90e/documents/decaaf70-20ed-4705-9c19-aa4f642258b8_d8fc9129-eaef-498d-a9b0-2580e6d809c5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat 1-imino-1H-isoindol-3-amine,3468-11-9," For this enpoint, two key studies are available, one for oral and one for dermal toxicity. No data are available on acute toxicity via inhalation. Acute oral toxicity: The purpose of this study was to assess the oral acute toxicity of the test article when administered to rats (OECD 423, GLP). One group was treated with a single oral dose of 300 mg/kg bw. Two further groups were treated with an oral dose of 50 mg/kg bw (gavage). The median lethal dose of the test item after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): 200 mg/ kg bw. Acute dermal toxicity: In order to determine the potential acute dermal toxicity of the test item, an acute dermal study on the rat was performed according to OECD 402 and in compliance to GLP. Wistar rats (5 male and 5 female) were exposed for 24h to 2000 mg/kg bw test substance. The dermal LD50was determined to be > 2000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b386e32d-9dfb-417d-a00f-aec09b68a90e/documents/cd2c6ca4-b936-4b89-b53b-abe6bd1a3b20_d8fc9129-eaef-498d-a9b0-2580e6d809c5.html,,,,,, 1-imino-1H-isoindol-3-amine,3468-11-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b386e32d-9dfb-417d-a00f-aec09b68a90e/documents/cd2c6ca4-b936-4b89-b53b-abe6bd1a3b20_d8fc9129-eaef-498d-a9b0-2580e6d809c5.html,,oral,LD50,200 mg/kg bw,adverse effect observed, 1-imino-1H-isoindol-3-amine,3468-11-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b386e32d-9dfb-417d-a00f-aec09b68a90e/documents/cd2c6ca4-b936-4b89-b53b-abe6bd1a3b20_d8fc9129-eaef-498d-a9b0-2580e6d809c5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-isocyanato-3-(methylsulfanyl)benzene,28479-19-8, No data available. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d01f47c8-6820-4750-aab5-41286d528c50/documents/f31e49ea-147a-4530-af8c-8b304cc4aea5_3ce8b2b3-5efb-422d-bdb3-b25ca15b4758.html,,,,,, 1-isocyanato-3-(methylsulfanyl)benzene,28479-19-8, No data available. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d01f47c8-6820-4750-aab5-41286d528c50/documents/12d2e419-eb27-457a-97ce-31565e311d0e_3ce8b2b3-5efb-422d-bdb3-b25ca15b4758.html,,,,,, 1-isopropyl-4-methylcyclohexane,99-82-1,"OECD 422 Daily oral administration of the test substance to Wistar rats at dose levels of 111, 333, and 1000 mg/kg body weight over a period of 44 to 57 days resulted at the highest dose level in a reduction of the body weight gain and an increased water and food consumption in male animals. The water consumption was increased in females of the high dose group. Test item related changes in organ weight were found in the liver, the kidney and thymus of male animals. Furthermore, in male rats the histopathological examination indicated a nephrotoxic effect in all dose groups. At the highest dose level, the test item also showed a potential effect on the metabolism of the liver as well as an influence on uterus weight of female rats. The NOAEL is 333 mg/kg bw for females. In males based on the effects on the kidney a LOAEL of 111 mg/kg bw was derived. As these effects are considered of less relevance for humans, the NOAEL used in risk assessment is set at 333 mg/kg bw.   OECD 408 Male and female rats (10/sex/dose) were treated with the substance at 0, 100, 300 and 1000 mg/kg bw by gavage for 90 days according to OECD 408. No treatment findings on mortality, food intake and haematology were noted. At 1000 mg/kg bw liver and kidney weights were increased in males and females. In animals at 1000 mg/kg bw a time-related increased incidence of piloerection, decreased motility and laying in a rigid position was seen lasting up to 1.5 hours after dosing from day 28 onwards. In females at 1000 mg/kg bw body weight (gain) was within control ranges, but slight effects on biochemistry (total protein (globulin), ALP, bile acids and cholesterol) were observed. Liver and kidney weights were increased. Macroscopic and histopathological evaluation of these females showed enlarged and pale kidneys with hyaline casts. The lungs showed aspired blood and focal lipidosis. The NOAEL for females is therefore set at 300 mg/kg bw. Males at 1000 mg/kg bw had a decreased body weight (gain). In addition these males showed decreased blood alkeline phosphatase levels and increased urinary ketone bodies and protein. At 300 and 1000 mg/kg kidney and liver weights increased in a dose dependent way. This was not accompanied by macroscopic and histological findings in the liver, but kidneys were found to be enlarged/pale containing hyaline droplets, hyaline casts, tubular basophilia and tubular necrosis indicative of chronic progressive nephrosis. Similar effects in the kidney were observed in all males at 100 and 300 mg/kg bw. These effects were confirmed to be related to α2-microglobulin (immunohistochemistry) and are therefore not relevant to humans. Effects in the lungs were similar to those found in females. Based on these findings no NOAEL could be set for males. The NOAEL for females will be used as starting point for risk assessment.   Based on the information above and the absence of effects in a study according to OECD 414 at 1000 mg/kg bw (highest dose tested), the NOAEL that will be used as starting point for the risk assessment is set at 300 mg/kg bw. It is expected that this value is sufficiently protective for potential effects on fertility. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/680506fa-4a32-4c0f-a9b8-10dfed627fd9/documents/2af75c2e-cce5-4373-bccf-3b9a767cffdd_110c3ea9-46b9-48ed-853b-a85b0b9fca60.html,,,,,, 1-isopropyl-4-methylcyclohexane,99-82-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/680506fa-4a32-4c0f-a9b8-10dfed627fd9/documents/2af75c2e-cce5-4373-bccf-3b9a767cffdd_110c3ea9-46b9-48ed-853b-a85b0b9fca60.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 1-isopropyl-4-methylcyclohexane,99-82-1,The oral LD50 in rats is >3000 mg/kg bw (Hüls 1989). The dermal LD50 in rats is > 2000 mg/kg bw (TC 2012). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/680506fa-4a32-4c0f-a9b8-10dfed627fd9/documents/0923f6c8-4d1d-46e8-95bd-b89148f018e8_110c3ea9-46b9-48ed-853b-a85b0b9fca60.html,,,,,, 1-isopropyl-4-methylcyclohexane,99-82-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/680506fa-4a32-4c0f-a9b8-10dfed627fd9/documents/0923f6c8-4d1d-46e8-95bd-b89148f018e8_110c3ea9-46b9-48ed-853b-a85b0b9fca60.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, 1-isopropyl-4-methylcyclohexane,99-82-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/680506fa-4a32-4c0f-a9b8-10dfed627fd9/documents/0923f6c8-4d1d-46e8-95bd-b89148f018e8_110c3ea9-46b9-48ed-853b-a85b0b9fca60.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-methoxy-4-[3-methyl-4-(2-phenylethoxy)but-3-en-1-yl]benzene,2489703-47-9,"Oral (gavage): NOAEL (rat, systemic toxicity): ≥ 150 mg/kg bw/day, male/female, OECD TG 422, 2022 Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The key study is GLP compliant and of a high quality (Klimisch 1); The available information as a whole meets the tonnage driven information requirements of REACH. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/718d5b2c-9d9c-4344-838d-0aea5f53b44f/documents/b1d53881-78bb-4d8b-ba6a-025f30fd37ea_d8418966-f2b5-4daa-90ec-97f38a00729b.html,,,,,, 1-methoxy-4-[3-methyl-4-(2-phenylethoxy)but-3-en-1-yl]benzene,2489703-47-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/718d5b2c-9d9c-4344-838d-0aea5f53b44f/documents/b1d53881-78bb-4d8b-ba6a-025f30fd37ea_d8418966-f2b5-4daa-90ec-97f38a00729b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat 1-methoxy-4-[3-methyl-4-(2-phenylethoxy)but-3-en-1-yl]benzene,2489703-47-9," Oral: LD50 > 2000 mg/kg bw and the LD50 cut-off was considered to be > 5000mg/kg bw female rat, OECD TG 423, 2021 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/718d5b2c-9d9c-4344-838d-0aea5f53b44f/documents/c9d5299a-280c-4a30-9b73-03a1b4f982a9_d8418966-f2b5-4daa-90ec-97f38a00729b.html,,,,,, 1-methoxy-4-[3-methyl-4-(2-phenylethoxy)but-3-en-1-yl]benzene,2489703-47-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/718d5b2c-9d9c-4344-838d-0aea5f53b44f/documents/c9d5299a-280c-4a30-9b73-03a1b4f982a9_d8418966-f2b5-4daa-90ec-97f38a00729b.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 1-methyl-1-phenylethyl peroxyneodecanoate,26748-47-0," The target substance 1 -Methyl-1-phenylethyl peroxyneodecanoate was tested in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422). Dose groups chosen were based on the results of a 14-day dose range finding study. No adverse effects were found on male and female mortality, clinical observations, functional observations, body weight development (except HD males and females), food consumption (except HD females), estrous cyclicity, haematology and coagulation, clinical biochemistry, urinalysis and gross macroscopic findings at necropsy in all treatment groups. In the high dose group treated with 1000 mg/kg bw/day treatment related effects on organ weights (liver, kidney, uterus with cervix weights, heart, spleen) and histopathology (liver) were observed. Based on the results, the NOAEL for repeated dose toxicity is considered to be 300 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83806fb9-39a0-4dae-9ba3-4f183043441d/documents/641beefe-c9d9-4c69-825f-9c15857111dc_977e9540-66e1-43ff-ba36-41fab77ee073.html,,,,,, 1-methyl-1-phenylethyl peroxyneodecanoate,26748-47-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83806fb9-39a0-4dae-9ba3-4f183043441d/documents/641beefe-c9d9-4c69-825f-9c15857111dc_977e9540-66e1-43ff-ba36-41fab77ee073.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 1-methyl-1-phenylethyl peroxyneodecanoate,26748-47-0," For 1-Methyl-1-phenylethyl peroxyneodecanoate (target substance), suitable data are available to assess the acute toxicity. In an acute oral in vivo toxicity study conducted similar to OECD 401, Charles River CD rats (5/sex/dose) were orally exposed to 2034, 3229, 5126, 8137 and 12918 mg/kg bw Cumyl peroxyneodecanoate (target substance, 90.2% purity). In this study, the oral LD50 in rats in considered to be 5126 mg/kg bw. In a second available acute oral in vivo toxicity study conducted according to OECD 401, Sprague-Dawley rats were given a single oral dose of TRIGONOX 99-C75 (target substance, 75% purity). In this study, the oral LD50 in rats is considered to be greater than 2000 mg/kg bw. In an acute inhalation toxicity study similar to OECD 403, Charles River CD rats were exposed by inhalation route to LUPERSOL 188M75 containing 75.5% cumyl peroxyneodecanoate (0.19% Hydro; 896 ppm Cl-) for 1 hour via whole body exposure at a concentration of 20.4 mg/L. No mortality occurred during the 14-day observation period. In an acute dermal toxicity study conducted similar to OECD 402, groups of New Zealand White rabbits (three/sex) were dermally exposed to Cumyl peroxyneodecanoate (90.2% purity) for 72 hours at doses of 500, 1250, 3150, 7940 and 19800 mg/kg bw. Based on the results, the dermal LD50 was considered to be within < 19800 and > 7940 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83806fb9-39a0-4dae-9ba3-4f183043441d/documents/e404a728-84e5-4a83-ba97-cbe69220dee6_977e9540-66e1-43ff-ba36-41fab77ee073.html,,,,,, 1-methyl-1-phenylethyl peroxyneodecanoate,26748-47-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83806fb9-39a0-4dae-9ba3-4f183043441d/documents/e404a728-84e5-4a83-ba97-cbe69220dee6_977e9540-66e1-43ff-ba36-41fab77ee073.html,,dermal,LD50,"7,940 mg/kg bw",adverse effect observed, 1-methyl-3-phenylpropylamine,22374-89-6,"Acute oral toxicity: Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the toxic nature of the test chemical 1-methyl-3-phenylpropylamine (CAS no.: 22374-89-6).The studies are as mentioned below:   1. Acute Oral Toxicity Study of given test chemical was conducted as per OECD No. 423 on 6 female Wistar rats at the concentration of 2000 mg/kg bw. The animals were fasted for minimum 16-18 hours prior to dosing and for 3-4 hours post dosing, with food withheld but drinking water provided ad libitum. The time intervals between dosing were determined by the onset, duration and severity of toxic signs. Three rats of first group were dosed with starting dose of 2000 mg/kg body weight and the animals did not show any mortality so another three animals of the same group were dosed with 2000 mg/kg body weight and no mortality was observed. Hence, further dosing was stopped. Body weights were re­corded on day 0 (prior to dosing) 7 and 14.Body weight gain was observed in all the animals treated with 2000 mg/kg body weight, during the 14 day observation period, as compared to day 0. At 2000 mg/kg, animal nos. 1, 2, 3, 5 and 6 were observed normal throughout the experimental period, whereas animal no. 4 was observed normal at 30 minutes, 1, 2, 3 and 4 hours, with mild ataxia from day 1 to 4, with mild tremors on day 1, with mild chromodacryorrhea from day 2 to 6 and with moderate to mild lethargy from day 3 to 9 post dosing followed by normal observation till day 14. No external and internal gross pathological changes were seen in all the six animals treated with 2000 mg/kg body weight during terminal sacrifice. No mortality was observed in the animals treated with 2000 mg/kg dose throught out the 14 days observation period post dosing. Hence the LD50 was considered to be >2000mg/kg bw, when female Wistar rats were treated with test chemical orally.    2. The acute oral toxicity study was conducted by using test chemical in 40 male and female rats at the concentration of 2510, 3160, 3980 or 5000 mg/kg orally by gavage and observed for 14 days. In preliminary studies, dose levels of 316, 1260 and 5000 mg/kg resulted in mortality in 0/2, 0/2 and 2/2 rats from low to high dose. In main study, all animals were died at 5000 mg/kg bw, 9 animals died at 3980 mg/kg bw, 6 animals died at 3160 mg/kg bw and 4 animals died at 2510 mg/kg. Sedation and tremors were observed in treated rats. No gross pathological alterations were observed in treated male and female rats at necropsy. Therefore, LD50 was considered to be 2850 mg/kg bw, with 95% confidence limit of 2252-3608 mg/kg bw, when male and female rats were treated with test chemical via oral gavage route. Thus, based on the above summarised studies, 1-methyl-3-phenylpropylamine (CAS no.: 22374-89-6) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 1-methyl-3-phenylpropylamine (CAS no.: 22374-89-6) cannot be classified for acute oral toxicity. Hence, based on the data available for the structurally similar read across chemical, 1-methyl-3-phenylpropylamine is not likely to be toxic atleast in the dose range of >2000-2850 mg/Kg bw.   Acute Inhalation Toxicity: Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the toxic nature of the test chemical 1-methyl-3-phenylpropylamine (CAS no.: 22374-89-6). The studies are as mentioned below:   1. The acute inhalation toxicity study was conducted by using test chemical in rats at the concentration of 5000 mg/m3 inhaled as a Single dose. No mortality was observed at 5000 mg/m3. Therefore, LC50 value was considered to be >5000 mg/ m3 (>5 mg/L) when rats were exposed with test chemical by inhalation route.   2. The acute inhalation toxicity study was designed and conducted according to OECD Guideline 403 (Acute Inhalation Toxicity) by using test chemical in 10 (5 males and 5 females) Wistar rats at the concentration of 5 mg/L by inhalation: aerosol via nose only exposure. The aerosol was generated by the used of Nanotek aerosol generator (particle size less than 1 micron). All exposure was conducted in a dynamic nose-only cylindrical chamber built from stainless steel and glass. The chamber had a volume of 8 liters with inner and outer chamber to minimize the fluctuation in concentration and temperature. All the animals uniformly exposed to aerosol drug concentration. For the inhalation purpose the rats were placed in polycarbonate holder tubes positioned   radically around exposure chamber, so that only the snouts and nostrils of the animals were exposed to the aerosol. The chamber was maintained at a slightly negative pressure to prevent leakage of the test atmosphere from the system, as well as its dilution with outside air. The exhaust air was decontaminated by subsequent passage through 1% NaOH solution, silica gel and activated charcoal filters. In limit test, 10 healthy Wistar albino rats of both sex body weight 200±20 gm were selected for study after acclimatization. The test groups of animals were exposed to aerosol at the concentration of 5 mg/L for period of 4 hrs. After exposure all the animals were closely observed for any clinical signs of toxicity at various intervals such as 1 hr, 2 hrs, 4 hrs, and 6 hrs on the day of test compound aerosol exposure and later on twice a day throughout the experimentation period of 14 days. The necropsy was performed on all the animals at termination of experiment. All the albino rats exposed to aerosol at the concentration of 5 mg/L did not show any clinical signs of intoxication. Furthermore, no mortality was observed throughout the period of observation. After 72 hrs, the result obtained from limit test was confirmed in another 10 animal of both sex at similar concentration following same guideline. No mortality at the tested dose level of 5.0 mg/L throughout the period of observation after exposure. The test compound did not elicit any clinical signs of intoxication at the tested aerosol concentration of 5 mg/L observed for the period of 14 days. The body weight of all the animals recorded individually on day 7th and 14th (post treatment) showed normal gain as compared to day 0th. No gross pathological changes were observed. Therefore, LC50 was considered to be >5 mg/L (>5000 mg/m3), when male and female Wistar rats were exposed with test chemical via inhalation route by nose only exposure for 4 hours.   Thus, based on the above summarised studies for the Target chemical 1-methyl-3-phenylpropylamine (CAS no.: 22374-89-6) and it’s structurally similar read across substances, it can be concluded that LC50 value is >5 mg/L. Thus, comparing this value with the criteria of CLP regulation, 1-methyl-3-phenylpropylamine (CAS no.: 22374-89-6) cannot be classified for acute inhalation toxicity. Hence, based on the data available for the structurally similar read across chemical, 1-methyl-3-phenylpropylamine is not likely to be toxic at least in the dose of >5 mg/L.   Acute Dermal toxicity:  The study need not be conducted because the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5). The experimental pH of 1-methyl-3-phenylpropylamine (CAS no.: 22374-89-6) was 11.6. Hence this endpoint was considered for waiver.   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9cab81f-b1d8-4ad8-91d4-81b24b435a30/documents/69156491-4034-40e8-bf32-2e61c482b250_b6108602-fc62-40d3-84c3-a036b034a9b1.html,,,,,, 1-methyl-3-phenylpropylamine,22374-89-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9cab81f-b1d8-4ad8-91d4-81b24b435a30/documents/69156491-4034-40e8-bf32-2e61c482b250_b6108602-fc62-40d3-84c3-a036b034a9b1.html,,oral,LD50,"2,850 mg/kg bw",no adverse effect observed, 1-methyl-3-phenylpropylamine,22374-89-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9cab81f-b1d8-4ad8-91d4-81b24b435a30/documents/69156491-4034-40e8-bf32-2e61c482b250_b6108602-fc62-40d3-84c3-a036b034a9b1.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, 1-methylheptyl acrylate,42928-85-8,"Data for 2-Octyl acrylate:  2-Octyl acrylate was tested in a combined 28-day repeated dose toxicity study with reproduction/developmental toxicity screening test was performed according to OECD 422 by oral gavage, the dose levels in this study were selected to be 0, 100, 300, 1000 mg/kg bw/day. There were no unscheduled deaths that were considered to be related to treatment with the test item. No parental toxicity was observed up to 300 mg/kg bw/day. Males at 1000 mg/kg/day showed a lower mean relative food consumption over the first three weeks of treatment (0.90-0.94x of control; not statistically significant), followed by recovery to normal values in the last week of treatment (Week 4). Females at 1000 mg/kg/day showed a significant lower mean relative food consumption in the second half of gestation starting post-coitum Days 11-14 and 17-20 (0.93 and 0.92x of control). Test item-related morphological findings were noted in the stomach (both sexes), and kidney and liver (males only): • Stomach (both sexes): Findings were present in the forestomach consisting of hyperkeratosis in males starting at 300 mg/kg bw/day and in females at 1000 mg/kg bw/day (up to slight degree). In males, in addition, squamous cell hyperplasia (up to slight degree) was seen starting at 300 mg/kg bw/day, and in one male at 1000 mg/kg bw/day focal mixed cell inflammation (slight) was noted.• Kidney (males): An increased incidence and severity of hyaline droplet accumulation starting at 300 mg/kg bw/day (minimal-slight) was observed. At 1000 mg/kg bw/day, this was accompanied by tubular basophilia (minimal-moderate) and/or granular casts (minimal-moderate) Higher liver weights (absolute and relative to body weights) were recorded for males at 1000 mg/kg bw/day. This was regarded test item-related, but not adverse, based on the absence of any macroscopic and/or microscopic findings at the tissue level.No test item-related or toxicologically significant changes were noted in any of the remaining parameters investigated in this study (i.e. mortality/viability, clinical appearance, functional observations (motor activity, grip strength, hearing ability, pupillary reflex and static righting reflex), body weight, food consumption, hematology, clotting and clinical biochemistry parameters, including male T4 thyroid hormone levels). In conclusion, based on the results of this combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the following parental NOAEL for the test item was established: 300 mg/kg bw/day     Read across to 2-Ethylhexyl acrylate: 2-Ethylhexyl acrylate was administered to groups of 25 male and 25 female healthy young Wistar rats (F0 parental generation) as a homogeneous addition to the food in different concentrations (0, 1500, 5000 and 12500 ppm). These concentrations were reduced to 50% (750, 2500 and 6250 ppm) during lactation. This dietary adjustment, derived from historical body weight and food consumption data, maintained the dams at the desired target doses of 2-Ethylhexyl acrylate during this period of increased food intake.Stability, correct concentrations and homogeneous distribution of 2-Ethylhexyl acrylate in the diet were all confirmed through analytics.For the male animals the overall mean dose of 2-Ethylhexyl acrylate throughout all study phases and across all cohorts was approx. 119 mg/kg body weight/day (mg/kg bw/d) in the 1500 ppm group, approx. 357 mg/kg bw/d in the 5000 ppm group and approx. 998 mg/kg bw/d in the 12500 ppm group. For the female animals the overall mean dose of 2-Ethylhexyl acrylate throughout all study phases and across all cohorts was approx. 135 mg/kg bw/d in the 1500 ppm group, approx. 453 mg/kg bw/d in the 5000 ppm group and approx. 1136 mg/kg bw/d in the 12500 ppm group.There were no test substance-related mortalities or adverse clinical observations noted in any of the treatment groups in the F0 parental animals and F1 offspring. In particular, regularly conducted detailed clinical observations revealed no effects. The high concentration of the test substance (12500 ppm) produced signs of adverse local effects which were subsequently conveyed to some subsequent systemic effects in the F0 parental rats and F1 adolescents.In the 12500 ppm and partly also 5000 ppm F0 parental animals food consumption was reduced during several episodes of the study. No comparable findings were noted in the F1A and F1B offspring. Although they might be related to the irritating properties of the test item (see pathology), those changes were minor and followed a patchy pattern, thus they did not qualify as adverse test substance-related effects by themselves.Body weights and body weight change of the 12500 ppm male F0 and F1 rats were consistently and, in many parts of the study significantly, below the concurrent control across all cohorts and study periods, including terminal body weight. Female F0 and F1 rats were less sensitive against this effect, significant body weight decreases were limited to single episodes during the study, overall the pattern and severity of changes pointed toward a borderline outcome.Concerning clinical pathology, no treatment-related, adverse effects were observed up to a dose of the test compound of 12500 ppm in F0 as well as F1A rats of both sexes. Regarding pathology, target organs were the glandular stomach and the kidneys. Thus, under the conditions of the present extended one-generation reproduction toxicity study the NOAEL (no observed adverse effect level) for general, systemic toxicity is 5000 ppm (about 357 mg/kg bw/d in males, 453 mg/kg bw/d in females) in the F0 parental and the F1 adolescent/adult rats, based on evidence for local toxicity in the gastrointestinal tract which conveyed to systemic toxicity such as decreased body weight/body weight gain across generations and cohorts, at the LOAEL (Lowest Observed Adverse Effect Level) of 12500 ppm (about 998 mg/kg bw/d in males, 1136 mg/kg bw/d in females). Study on the Inhalation Toxicity of 2-Ethylhexyl Acrylate as a Vapor in Rats (3-Months Study). In a valid 90-day inhalation study (BASF, 1989) Wistar rats were administered in a whole-body exposition on 6 hours per day, 5 days per week, to 2-EHA vapour at concentrations of 0 ppm, 10 ppm, 30 ppm or 100 ppm (approximately 0.075 mg/l, 0.225 mg/l or 0.750 mg/l for the treatment groups) (2-EHA purity 99.7%). The study design was conducted according to OECD 413 (1981). Compared to the actual version of the test guideline, validity is restricted in that food consumption was not recorded, lung tissues were not perfused, and laryngopharynx was not examined. Histopathologic examination was carried out on 31 organs/tissues of high dose and control animals. The lungs, nasal cavity, thyroid and parathyroid glands, trachea and liver from all animals/all test groups were subjected to histopathology examination.There were no treatment-related premature deaths. During exposure period animals of the high and mid dose groups exhibited lethargy and ptosis. Body weight gain was lower in both sexes of the high dose during and at the end of the study. A transiently reduced body weight gain was observed in mid dose females. From day 21 onwards mean body weight (absolute) was lower in high dose males compared to the control group. This parameter was not significantly altered in any other group at any time point during the study. Activities of ALAT and alkaline phosphatase were elevated in high dose females. In high dose males and females lower levels of total protein, albumin and glucose were demonstrated. Reduced protein and albumin values were also seen in each sex of the mid dose groups.Absolute liver weight was reduced in high dose males and relative adrenal weights were lower in high dose males and females compared to the control groups. The microscopic examination revealed no lesion other than a focal or diffuse degeneration of the olfactory epithelium of the cranial nasal cavity in animals of both sexes of the high and mid dose groups. All rats of the 100 ppm group showed degeneration of the olfactory mucosa in the anterior part of the nasal cavity. The incidence of degeneration of the olfactory mucosa but not the severity was increased in mid dose rats. No treatment-related lesion of the nasal cavity was diagnosed at the low dose level.Degeneration of the olfactory epithelium was characterised by a reduction of cell layers, reduction or loss of apical cytoplasmic structures such as olfactory knobs and microvilli, and by necrosis. Identification of the remaining olfactory mucosa cells was not possible. Occasional mitosis were present.In detail, degeneration of the olfactory mucosa was diagnosed in the anterior part of the nasal turbinates (level 1) in all high dose rats and in four males and four females of the mid dose group. At the high dose level, the degeneration affected the olfactory mucosa diffusely in the dorsal and dorsolateral area, and the severity was mainly moderate. Mid dose animals showed small areas of degeneration of the dorsolateral olfactory mucosa of minimal severity. At level 2 of the turbinates, degeneration was diagnosed in all high dose rats, one mid dose male, two female and one female of the low dose group, and in one control group male. In the high dose group, the degeneration was diffuse in the dorsal and dorsolateral region, whereas in the other groups the degeneration was focal. The severity was minimal to marked in the high dose group, and mainly minimal in the other groups. Slight degeneration of the olfactory mucosa of the level 3 was diagnosed in one male and one female each of the high dose group. 2 -EHA induce no lesions of the trachea and the lungs.The No-observed-adverse-effect-level (NOAEL) for the local effects on the respiratory tract was 10 ppm (0.075 mg/l), and the NOAEC for systemic effects was 30 ppm (0.226 mg/l). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34806031-1fd2-4041-9582-6398b057ae81/documents/46dd1757-48f5-4258-adf7-ce5abe7ba15b_0a12f9d9-ee76-45ee-ab85-6f9bf266668e.html,,,,,, 1-methylheptyl acrylate,42928-85-8,"LD50 (oral, rat): 2000 mg/kg LC50 (inh., rat): > 4.7 mg/L ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34806031-1fd2-4041-9582-6398b057ae81/documents/2e18bd13-6ef1-4e2c-a681-e0fd010f82bc_0a12f9d9-ee76-45ee-ab85-6f9bf266668e.html,,,,,, 1-methylheptyl acrylate,42928-85-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34806031-1fd2-4041-9582-6398b057ae81/documents/2e18bd13-6ef1-4e2c-a681-e0fd010f82bc_0a12f9d9-ee76-45ee-ab85-6f9bf266668e.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, 1-methylheptyl acrylate,42928-85-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34806031-1fd2-4041-9582-6398b057ae81/documents/2e18bd13-6ef1-4e2c-a681-e0fd010f82bc_0a12f9d9-ee76-45ee-ab85-6f9bf266668e.html,,inhalation,LC50,> 4.7 mg/L,, 1-methylimidazole,616-47-7,"The NOAEL for general, systemic toxicity of the test substance is 90 mg/kg bw/day, derived from an GLP OECD TG study in rats (subchronic, gavage). Due to severe effects in the Range Finding Studies, this was the highest possible dose to be tested. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Sufficient due to GLP OECD TG studies. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dbc12234-70b8-4d3e-abd9-bd02d9085abc/documents/72e936c3-8165-4605-a29c-ad4fc3a818e5_051d3934-a963-4749-8fd4-014e932912d9.html,,,,,, 1-methylimidazole,616-47-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dbc12234-70b8-4d3e-abd9-bd02d9085abc/documents/72e936c3-8165-4605-a29c-ad4fc3a818e5_051d3934-a963-4749-8fd4-014e932912d9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,90 mg/kg bw/day,,rat 1-methylimidazole,616-47-7,The oral LD50 was ca. 1144 mg/kg bw in rats. A LD50 value of 400 < LD50 < 640 mg/kg bw was observed for rabbits after acute dermal exposure. No mortality after 8 h exposure to the saturated vapour-air-mixture. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbc12234-70b8-4d3e-abd9-bd02d9085abc/documents/ad911500-c2ab-4965-b007-6940bf294a39_051d3934-a963-4749-8fd4-014e932912d9.html,,,,,, 1-methylimidazole,616-47-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbc12234-70b8-4d3e-abd9-bd02d9085abc/documents/ad911500-c2ab-4965-b007-6940bf294a39_051d3934-a963-4749-8fd4-014e932912d9.html,,oral,LD50,"1,144 mg/kg bw",adverse effect observed, 1-methylimidazole,616-47-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbc12234-70b8-4d3e-abd9-bd02d9085abc/documents/ad911500-c2ab-4965-b007-6940bf294a39_051d3934-a963-4749-8fd4-014e932912d9.html,,dermal,discriminating dose,400 mg/kg bw,adverse effect observed, 1-methylimidazole,616-47-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbc12234-70b8-4d3e-abd9-bd02d9085abc/documents/ad911500-c2ab-4965-b007-6940bf294a39_051d3934-a963-4749-8fd4-014e932912d9.html,,inhalation,discriminating conc.,"1,200 mg/m3",no adverse effect observed, "1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine",37697-65-7," In the key acute oral toxicity study the LD50 for 1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine was reported to be 1280 mg/kg bw in rats. The study was conducted to the now deleted OECD 401 guideline and to GLP, (Hazleton, 1989). In an acute dermal toxicity study conducted to OECD TG 402 and in compliance with GLP, the LD50, for 1-Methyl-N,N',N''-tris(1-methylpropyl)silanetriamine, was >2008 mg/kg bw  (Hazleton, 1989). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2401b372-b144-4c96-8580-c4b6fe288873/documents/IUC5-4c574606-ef2a-4b6f-bb54-00efe45ab9ed_e7db4e8f-5884-48a4-8ae8-73883b77016c.html,,,,,, "1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine",37697-65-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2401b372-b144-4c96-8580-c4b6fe288873/documents/IUC5-4c574606-ef2a-4b6f-bb54-00efe45ab9ed_e7db4e8f-5884-48a4-8ae8-73883b77016c.html,,oral,LD50,"1,280 mg/kg bw",adverse effect observed, "1-methyl-N,N',N''-tris(1-methylpropyl)silanetriamine",37697-65-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2401b372-b144-4c96-8580-c4b6fe288873/documents/IUC5-4c574606-ef2a-4b6f-bb54-00efe45ab9ed_e7db4e8f-5884-48a4-8ae8-73883b77016c.html,,dermal,LD50,"2,008 mg/kg bw",no adverse effect observed, 1-methylpiperidin-4-ol,106-52-5," Repeated dose toxicity: oral The No Observed Adverse Effect Level (NOAEL) for the test compound 1-Methyl-4-hydroxypiperidine for rats was estimated to be 1029 mg/kg bw/day (nominal). Repeated dose toxicity: inhalation A short term toxicity does not needs to be conducted because exposures of humans via inhalation in production and/or use is not likely as based on provided thorough and rigorous exposure assessment (exposure considerations). Repeated dose toxicity: dermal The acute toxicity value for 1-methylpiperidin-4-ol (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 1-methylpiperidin-4-ol shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 1-methylpiperidin-4-ol shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38386558-41d9-4a36-8373-507abb32d867/documents/IUC5-1c813d0b-cb44-4b14-bcbc-1cb2d04ccddc_d0fb9867-b103-478b-ac92-4021e3801956.html,,,,,, 1-methylpiperidin-4-ol,106-52-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38386558-41d9-4a36-8373-507abb32d867/documents/IUC5-1c813d0b-cb44-4b14-bcbc-1cb2d04ccddc_d0fb9867-b103-478b-ac92-4021e3801956.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,029 mg/kg bw/day",,rat 1-methylpiperidin-4-ol,106-52-5," Acute toxicity: oral Acute oral LD50 value for the test substance 1-methylpiperidin-4-ol was estimated to be 2119 mg/kg bw for rats. Acute toxicity: inhalation The study does not needs to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of inhalable size. Acute toxicity: dermal Acute dermal LD50 value for the test substance 1-methylpiperidin-4-ol was estimated to be 2526.7 mg/kg bw for rabbits. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38386558-41d9-4a36-8373-507abb32d867/documents/IUC5-6328c82d-40e5-4433-91b4-608b0c8d7443_d0fb9867-b103-478b-ac92-4021e3801956.html,,,,,, 1-methylpiperidin-4-ol,106-52-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38386558-41d9-4a36-8373-507abb32d867/documents/IUC5-6328c82d-40e5-4433-91b4-608b0c8d7443_d0fb9867-b103-478b-ac92-4021e3801956.html,,oral,LD50,"2,119 mg/kg bw",no adverse effect observed, 1-methylpiperidin-4-ol,106-52-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38386558-41d9-4a36-8373-507abb32d867/documents/IUC5-6328c82d-40e5-4433-91b4-608b0c8d7443_d0fb9867-b103-478b-ac92-4021e3801956.html,,dermal,LD50,"2,526.7 mg/kg bw",, 1-methylpyrrolidine,120-94-5,The available studies are comparable to guideline studies and sufficient for assessment. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11649b15-2161-4f90-a0f3-ddc647cd0ac3/documents/IUC5-7f56224d-c8df-4c6f-a6c9-2c4c0d242119_f282a890-f1ee-445c-97ba-0f95bea4919c.html,,,,,, 1-methylpyrrolidine,120-94-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11649b15-2161-4f90-a0f3-ddc647cd0ac3/documents/IUC5-7f56224d-c8df-4c6f-a6c9-2c4c0d242119_f282a890-f1ee-445c-97ba-0f95bea4919c.html,,oral,LD50,280 mg/kg bw,adverse effect observed, 1-methyltrimethylene dimethacrylate,1189-08-8,"Oral administration:  Combistudy (OECD 422/408), rat: NOAEL=200 mg/kg bw/d (2024) Inhalation:  Based on physico-chemical data, the inhalation of the substance is very unlikely. Furthermore, spray-application are excluded.    Dermal administration:  Based on physico-chemical data, the dermal absorption of the substance is very low.      ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49dc5209-52c0-4b09-bd6a-fb595e758bb3/documents/IUC5-598ddf4a-ed9e-4ebc-9d8d-6c24a7062ad2_ac25baee-da0d-4113-8b71-654594c20fd2.html,,,,,, 1-methyltrimethylene dimethacrylate,1189-08-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49dc5209-52c0-4b09-bd6a-fb595e758bb3/documents/IUC5-598ddf4a-ed9e-4ebc-9d8d-6c24a7062ad2_ac25baee-da0d-4113-8b71-654594c20fd2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat 1-methyltrimethylene dimethacrylate,1189-08-8,"Acute oral toxicity LD50 (rat): > 2000 mg/kg bw OECD Guideline 420; GLP study, Klimisch score = 1 (HMRTF, 2021) Acute inhalation toxicity: no relevant route of exposure Acute dermal toxicity: no relevant route of exposure One relevant, reliable (Klimisch score = 2) and adequate publication (peer-reviewed handbook data, pre-guideline study) is available. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49dc5209-52c0-4b09-bd6a-fb595e758bb3/documents/IUC5-040a90ce-504d-4d70-b31d-eaf2acb769dc_ac25baee-da0d-4113-8b71-654594c20fd2.html,,,,,, 1-methyltrimethylene dimethacrylate,1189-08-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49dc5209-52c0-4b09-bd6a-fb595e758bb3/documents/IUC5-040a90ce-504d-4d70-b31d-eaf2acb769dc_ac25baee-da0d-4113-8b71-654594c20fd2.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 1-methyltrimethylene dimethacrylate,1189-08-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49dc5209-52c0-4b09-bd6a-fb595e758bb3/documents/IUC5-040a90ce-504d-4d70-b31d-eaf2acb769dc_ac25baee-da0d-4113-8b71-654594c20fd2.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, "1-Naphthalenamine, 1,2,3,4-tetrahydro-, (1R)-",23357-46-2,"The median lethal dose of 1-Aminotetralin (read across, CAS 2217-40-5) after oral administration was found to be greater than 300 mg/kg and less than 500 mg/kg body weight in rats (OECD 423). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb3fa6e7-cd18-4fb1-9475-e1c32241b7d6/documents/IUC5-05fcfb2a-ed45-4adb-9361-d9d64ac8d7f9_c3591ebf-e22c-4b01-a5c0-461344eeba99.html,,,,,, "1-Naphthalenamine, 1,2,3,4-tetrahydro-, (1S)-",23357-52-0,"The median lethal dose of 1-Aminotetralin (read across, CAS 2217-40-5) after oral administration was found to be greater than 300 mg/kg and less than 500 mg/kg body weight in rats (OECD 423). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f1cbbdd-797e-4182-8b07-059fba6577b6/documents/IUC5-2a97bd18-b96f-43ed-9715-332742b9acd3_2ed3d8b2-0765-44eb-86d7-96d4185653e5.html,,,,,, "1-Naphthalenamine, 4-(3,4-dichlorophenyl)-1,2,3,4-tetrahydro-N-methyl-, hydrochloride (1:1), (1R,4R)-rel-",79617-89-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68a0804c-c402-4ba6-ad59-435943f5c913/documents/d7ac5c59-5e60-4c2d-a185-b5084675c3a3_73d5d681-2c5d-40eb-8214-4528dff6346f.html,,oral,LD50,"1,591 mg/kg bw",, "Oligomer of 4,4-bis(1,1,3,3-tetramethylbutyl)diphenylamine with N-(4-(2,4,4-trimethylpentan-2-yl)phenyl)naphthalen-1-amineor (according to REACH Guidance on substance identification)Reaction mass of N,N,N'-tri(4-(1,1,3,3-tetramethyl-butyl)phenyl-N'-(di(4-(1,1,3,3-tetramethylbutyl)phenyl)amino)-naphthylhydrazine, N,N,N'-tri(4-(1,1,3,3-tetramethyl-butyl)phenyl-N'-(bis-(di(4-(1,1,3,3-tetramethylbutyl)phenyl)amino))-naphthylhydrazine, N,N,N'-tri(4-(1,1,3,3-tetramethyl-butyl)phenyl-N'-(bis(N''-(4-(1,1,3,3-tetramethylbutyl)phenyl)amino)-N''-naphthyl)naphthylhydrazine, N,N,N'-tri(4-(1,1,3,3-tetramethyl-butyl)phenyl-N'-[x-(di-(4-(1,1,3,3-tetramethylbutyl)phenyl)amino-(4-(1,1,3,3-tetramethylbutyl)phenyl)-amino)naphthylamino)naphthyl-hydrazine, tetrakis 4-(1,1,3,3-tetra-Methyl-butyl)phenylhydrazine and N,N,N'-tris(4-(1,1,3,3-tetramethyl-butyl)phenyl-N'-naphthylhydrazine",68938-84-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8d501aa-c078-4fa8-83a8-67565368d2b9/documents/d1bfbd6b-6e84-487b-a084-3b69da27f065_72bd795f-4031-46e7-8809-46d8200b6435.html,,oral,LD50,"> 2,000 mg/kg bw",adverse effect observed, "Oligomer of 4,4-bis(1,1,3,3-tetramethylbutyl)diphenylamine with N-(4-(2,4,4-trimethylpentan-2-yl)phenyl)naphthalen-1-amineor (according to REACH Guidance on substance identification)Reaction mass of N,N,N'-tri(4-(1,1,3,3-tetramethyl-butyl)phenyl-N'-(di(4-(1,1,3,3-tetramethylbutyl)phenyl)amino)-naphthylhydrazine, N,N,N'-tri(4-(1,1,3,3-tetramethyl-butyl)phenyl-N'-(bis-(di(4-(1,1,3,3-tetramethylbutyl)phenyl)amino))-naphthylhydrazine, N,N,N'-tri(4-(1,1,3,3-tetramethyl-butyl)phenyl-N'-(bis(N''-(4-(1,1,3,3-tetramethylbutyl)phenyl)amino)-N''-naphthyl)naphthylhydrazine, N,N,N'-tri(4-(1,1,3,3-tetramethyl-butyl)phenyl-N'-[x-(di-(4-(1,1,3,3-tetramethylbutyl)phenyl)amino-(4-(1,1,3,3-tetramethylbutyl)phenyl)-amino)naphthylamino)naphthyl-hydrazine, tetrakis 4-(1,1,3,3-tetra-Methyl-butyl)phenylhydrazine and N,N,N'-tris(4-(1,1,3,3-tetramethyl-butyl)phenyl-N'-naphthylhydrazine",68938-84-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8d501aa-c078-4fa8-83a8-67565368d2b9/documents/d1bfbd6b-6e84-487b-a084-3b69da27f065_72bd795f-4031-46e7-8809-46d8200b6435.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1-Naphthaleneheptanoic acid, 8-(2,2-dimethyl-1-oxobutoxy)-1,2,6,7,8,8a-hexahydro-b,d-dihydroxy-2,6-dimethyl-, monoammonium salt,(bR,dR,1S,2S,6R,8S,8aR)- (9CI)",139893-43-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch 2 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18105702-a4fe-48f8-bfb7-0475d058b97b/documents/IUC5-b5e5ffe8-b543-4395-b921-503a271b1e04_0f8a36ab-bb4f-4328-a62c-b6661372c709.html,,,,,, "1-Naphthaleneheptanoic acid, 8-(2,2-dimethyl-1-oxobutoxy)-1,2,6,7,8,8a-hexahydro-b,d-dihydroxy-2,6-dimethyl-, monoammonium salt,(bR,dR,1S,2S,6R,8S,8aR)- (9CI)",139893-43-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18105702-a4fe-48f8-bfb7-0475d058b97b/documents/IUC5-b5e5ffe8-b543-4395-b921-503a271b1e04_0f8a36ab-bb4f-4328-a62c-b6661372c709.html,Chronic toxicity – systemic effects,oral,LOAEL,50 mg/kg bw/day,,rat "1-Naphthaleneheptanoic acid, 8-(2,2-dimethyl-1-oxobutoxy)-1,2,6,7,8,8a-hexahydro-b,d-dihydroxy-2,6-dimethyl-, monoammonium salt,(bR,dR,1S,2S,6R,8S,8aR)- (9CI)",139893-43-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Acute and Local Toxicity – Significant lethality was observed in mice after a single oral dose of 9 g/m2. No evidence of lethality was observed in rats or dogs treated with doses of 30 and 100 g/m2, respectively. No specific diagnostic signs were observed in rodents. At these doses the only signs seen in dogs were emesis and mucoid stools2. Oral LD50 values in the dog, mouse and rat models were >5000, 3000 and 4438 mg/kg, respectively1. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18105702-a4fe-48f8-bfb7-0475d058b97b/documents/IUC5-ac70344a-f4d6-448d-adf4-4cf45e356f7c_0f8a36ab-bb4f-4328-a62c-b6661372c709.html,,,,,, "1-Naphthaleneheptanoic acid, 8-(2,2-dimethyl-1-oxobutoxy)-1,2,6,7,8,8a-hexahydro-b,d-dihydroxy-2,6-dimethyl-, monoammonium salt,(bR,dR,1S,2S,6R,8S,8aR)- (9CI)",139893-43-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18105702-a4fe-48f8-bfb7-0475d058b97b/documents/IUC5-ac70344a-f4d6-448d-adf4-4cf45e356f7c_0f8a36ab-bb4f-4328-a62c-b6661372c709.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, methyl(naphthalen-1-ylmethyl)amine hydrochloride,65473-13-4,The data reported suggest that substance does not effect on acute toxicity by oral route The data reported suggest that substance does not effect on acute toxicity by oral route but the quality of information is scarce and the classification is inconclusive. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13815360-e067-4d10-80c4-7dc355eb477a/documents/IUC5-0a7632a8-fb73-4997-9093-91a701645044_02c9f8a9-471e-4992-aeb5-329907a71397.html,,,,,, methyl(naphthalen-1-ylmethyl)amine hydrochloride,65473-13-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13815360-e067-4d10-80c4-7dc355eb477a/documents/IUC5-0a7632a8-fb73-4997-9093-91a701645044_02c9f8a9-471e-4992-aeb5-329907a71397.html,,oral,LD50,"7,000 mg/kg bw",no adverse effect observed, "1-Naphthalenesulfonic acid, 3-diazo-3,4-dihydro-4-oxo-, ester with phenyl(2,3,4-trihydroxyphenyl)methanone 6-diazo-5,6-dihydro-5-oxo-1-naphthalenesulfonate",115682-47-8,"The acute median lethal oral dose (LD50) to rats of the test item was demonstrated to be greater than 2000 mg/kg body weight. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP and OECD Guideline conform study ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/151edba5-4b3d-408b-bae8-2a32a26982fb/documents/19e2f379-4fda-41f2-b010-c3d59e0dabc0_6934f24e-eb81-42a1-bd22-9d0bd305b50c.html,,,,,, "1-Naphthalenesulfonic acid, 3-diazo-3,4-dihydro-4-oxo-, ester with phenyl(2,3,4-trihydroxyphenyl)methanone 6-diazo-5,6-dihydro-5-oxo-1-naphthalenesulfonate",115682-47-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/151edba5-4b3d-408b-bae8-2a32a26982fb/documents/19e2f379-4fda-41f2-b010-c3d59e0dabc0_6934f24e-eb81-42a1-bd22-9d0bd305b50c.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1-Naphthalenesulfonic acid, 4-amino-, diazotized, coupled with diazotized 5(or 8)-amino-2-naphthalenesulfonic acid, diazotized 4-nitrobenzenamine and resorcinol",90459-11-3," LD50 (oral, rat) > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/159beaac-7875-45ab-a74f-5fb465b434fe/documents/2302776f-e79c-4a6f-a2d4-4be89c2bfd38_60bffb56-61df-46ec-b67b-f65d6d875f1a.html,,,,,, "1-Naphthalenesulfonic acid, 4-amino-, diazotized, coupled with diazotized 5(or 8)-amino-2-naphthalenesulfonic acid, diazotized 4-nitrobenzenamine and resorcinol",90459-11-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/159beaac-7875-45ab-a74f-5fb465b434fe/documents/2302776f-e79c-4a6f-a2d4-4be89c2bfd38_60bffb56-61df-46ec-b67b-f65d6d875f1a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-Naphthol, reaction products with formaldehyde",25359-91-5," Acute Oral, van Sas (2018) Under the conditions of this study the oral LD50 value of the test material in Wistar rats was established to exceed 2000 mg active ingredient/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0bf5d8af-a288-4eaa-8417-e7d14e6e747d/documents/1232eff0-7416-4bc4-9668-89764fae32af_b2f54ac3-6145-45d0-b8ef-421e9c3baa7b.html,,,,,, "1-Naphthol, reaction products with formaldehyde",25359-91-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0bf5d8af-a288-4eaa-8417-e7d14e6e747d/documents/1232eff0-7416-4bc4-9668-89764fae32af_b2f54ac3-6145-45d0-b8ef-421e9c3baa7b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-nitroguanidine,556-88-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): good quality based on guideline studies ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c5464ed-4c25-4fe6-bc5d-49c2ac5ea65c/documents/IUC5-45778da9-cb91-4fbd-9afc-0eb76d103877_3a136aae-1882-44ac-a9b7-da60a0df737a.html,,,,,, 1-nitroguanidine,556-88-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c5464ed-4c25-4fe6-bc5d-49c2ac5ea65c/documents/IUC5-45778da9-cb91-4fbd-9afc-0eb76d103877_3a136aae-1882-44ac-a9b7-da60a0df737a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 1-nitroguanidine,556-88-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): good quality based on guideline study ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c5464ed-4c25-4fe6-bc5d-49c2ac5ea65c/documents/IUC5-b4eb893d-0d91-48b7-a181-eed1507c2405_3a136aae-1882-44ac-a9b7-da60a0df737a.html,,,,,, 1-nitroguanidine,556-88-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c5464ed-4c25-4fe6-bc5d-49c2ac5ea65c/documents/IUC5-b4eb893d-0d91-48b7-a181-eed1507c2405_3a136aae-1882-44ac-a9b7-da60a0df737a.html,,oral,LD50,"4,345 mg/kg bw",no adverse effect observed, "Polyurea, produced by reacting diphenylmethane diisocyanate with octyl amine and stearyl amine",1312943-23-9," Short-term repeat oral toxicity studies were conducted on four substances in the MDI category: A mixture of: 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea; 3-cyclohexyl-1-(4-(4-(3-octadecylureido)benzyl)phenyl)urea; 3,3'-dioctadecyl-1,1'-methylenebis (4,1-phenylene)diurea (EC 406-530-2), 3,3'-dioctadecyl-1,1'- methylenebis(4,1-phenylene)diurea (EC 406-690-3), N,N''-(methylenedi-4,1-phenylene)bis[N'-octyl]urea (EC 445-760-8), 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-370-3), N,N''-(methylenedi- 4,1-phenylene)bis[N'-octyl]urea (EC 451-060-3). All studies were conducted over 28 days with 7 days/week dosing at three concentrations up to 1000 mg/kg bw/day. In the studies conducted on 3,3'-dioctadecyl-1,1'- methylenebis(4,1- phenylene)diurea (EC 406-690-3), A mixture of: 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea; 3-cyclohexyl-1- (4-(4-(3-octadecylureido)benzyl) phenyl)urea; 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-530-2) and 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-370-3), no treatment related findings were observed at any of the nominal concentrations tested and, therefore, the NOAEL and NOEL were determined to be 1000 mg/kg/b.w. day. In the study conducted on N,N''-(methylenedi-4,1-phenylene)bis[N'-octyl]urea (EC 445-760-8),, no treatment related findings were observed at any of the nominal concentrations tested, except for a slight slowing of body weight gain in males treated at a dose of 1000 mg/kg bw/day. Non-treatment related findings of increase in serum sodium and chloride levels in males treated with 450 and 1000 mg/kg/day and increased potassium in females at 1000 mg/kg/d were observed. Therefore, the substance was clinically well-tolerated at all doses tested and no significant variation / observation was noted in organ weights and macroscopic examination. The NOAEL and NOEL were determined to be 450 and 150 mg/kg b.w./day, respectively. All tests concluded that no classification is required. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2551e0c7-dce6-4ff5-a8fa-e86b0dc8e8c7/documents/d8e6eef8-265f-423c-b43b-0e1a98826de4_71614e0c-7fc5-4a7e-8a5a-727ceae641b3.html,,,,,, "Polyurea, produced by reacting diphenylmethane diisocyanate with octyl amine and stearyl amine",1312943-23-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2551e0c7-dce6-4ff5-a8fa-e86b0dc8e8c7/documents/d8e6eef8-265f-423c-b43b-0e1a98826de4_71614e0c-7fc5-4a7e-8a5a-727ceae641b3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat "Polyurea, produced by reacting diphenylmethane diisocyanate with octyl amine and stearyl amine",1312943-23-9," Acute oral toxicity studies were conducted on four MDI category members; A mixture of: 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea; 3-cyclohexyl-1-(4-(4-(3-octadecylureido)benzyl) phenyl)urea; 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-530-2), 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-370-3), N,N''-(methylenedi-4,1-phenylene) bis[N'-octyl]urea (EC 445-760-8), 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-690-3). The results from these studies showed no evidence of acute toxicity up to the highest dose tested in any study (2000 or 5000 mg/kg test item in either cellulose or corn oil). There is no evidence of a relevant intrinsic acute oral toxicity requiring classification or substance specific risk management measures.    Acute dermal toxicity limit studies were conducted on four MDI category members; A mixture of: 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea; 3-cyclohexyl-1-(4-(4-(3-octadecylureido)benzyl) phenyl)urea; 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-530-2), 3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-370-3), N,N''-(methylenedi-4,1-phenylene) bis[N'-octyl]urea (EC 445-760-8), 3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea (EC 406-690-3). The results from these studies showed no evidence of acute toxicity at the only dose tested in any study (2000 mg/kg test item). There is no evidence of a relevant intrinsic acute dermal toxicity requiring classification or substance specific risk management measures. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2551e0c7-dce6-4ff5-a8fa-e86b0dc8e8c7/documents/10863561-7751-4965-a066-9780a1ef443f_71614e0c-7fc5-4a7e-8a5a-727ceae641b3.html,,,,,, "Polyurea, produced by reacting diphenylmethane diisocyanate with octyl amine and stearyl amine",1312943-23-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2551e0c7-dce6-4ff5-a8fa-e86b0dc8e8c7/documents/10863561-7751-4965-a066-9780a1ef443f_71614e0c-7fc5-4a7e-8a5a-727ceae641b3.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Polyurea, produced by reacting diphenylmethane diisocyanate with octyl amine and stearyl amine",1312943-23-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2551e0c7-dce6-4ff5-a8fa-e86b0dc8e8c7/documents/10863561-7751-4965-a066-9780a1ef443f_71614e0c-7fc5-4a7e-8a5a-727ceae641b3.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctane-1-thiol",34451-26-8,Two in vivo studies are available performed according to OECD 423 guideline and GLP principles. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4dce3f7-b835-4fe9-88f6-a04b1bdf47bf/documents/IUC5-efed14f3-7b1d-4c3f-9edf-9d10f3b61dc0_3ad4af70-5ecb-4753-9100-8551268034ca.html,,,,,, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctane-1-thiol",34451-26-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4dce3f7-b835-4fe9-88f6-a04b1bdf47bf/documents/IUC5-efed14f3-7b1d-4c3f-9edf-9d10f3b61dc0_3ad4af70-5ecb-4753-9100-8551268034ca.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, 1-Octanol reaction products with epichlorhydrin and 2-mercaptoethanol,928768-73-4,"The oral administration of the test material to rats for a period of twenty-eight consecutive days, at dose levels of 25,150 and 1000 mg/kg/day resulted in treatment related effects at 1000 mg/kg/day. The effects however, were considered entirely adaptive in nature and considered not to represent an adverse health effect. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a17a231d-b442-43a1-a552-c2cd8f07ae12/documents/0935dd58-0708-43f2-b55c-4c21b3b59ae8_2253cc88-439d-4a2c-9f9a-442ff03401d1.html,,,,,, 1-Octanol reaction products with epichlorhydrin and 2-mercaptoethanol,928768-73-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a17a231d-b442-43a1-a552-c2cd8f07ae12/documents/0935dd58-0708-43f2-b55c-4c21b3b59ae8_2253cc88-439d-4a2c-9f9a-442ff03401d1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 1-Octanol reaction products with epichlorhydrin and 2-mercaptoethanol,928768-73-4,The oral LD50 is greater than 2000 mg/kg. The acute dermal median lethal dose (LDS0) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 2000 mg/kg bodyweight. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a17a231d-b442-43a1-a552-c2cd8f07ae12/documents/b76aad9f-e2f6-4cba-b320-588b5eb8e8ff_2253cc88-439d-4a2c-9f9a-442ff03401d1.html,,,,,, 1-Octanol reaction products with epichlorhydrin and 2-mercaptoethanol,928768-73-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a17a231d-b442-43a1-a552-c2cd8f07ae12/documents/b76aad9f-e2f6-4cba-b320-588b5eb8e8ff_2253cc88-439d-4a2c-9f9a-442ff03401d1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-Octanol reaction products with epichlorhydrin and 2-mercaptoethanol,928768-73-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a17a231d-b442-43a1-a552-c2cd8f07ae12/documents/b76aad9f-e2f6-4cba-b320-588b5eb8e8ff_2253cc88-439d-4a2c-9f9a-442ff03401d1.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-Octanol reaction products with epichlorhydrin and 2-mercaptoethanol,928768-73-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a17a231d-b442-43a1-a552-c2cd8f07ae12/documents/b76aad9f-e2f6-4cba-b320-588b5eb8e8ff_2253cc88-439d-4a2c-9f9a-442ff03401d1.html,,inhalation,LC50,4 mg/m3,adverse effect observed, "1-Octanol, reaction products with phosphorus oxide (P2O5), potassium salts",111062-42-1," 28-day oral Parental systemic NOAEL: at least 500 mg/kg. 28-day oral Parental local NOAEL: 50 mg/kg, based on adverse histopathological changes in the stomach (glandular and non-glandular) in males starting at 150 mg/kg. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f6fa768-d0ab-4407-bef5-806dd699a4c3/documents/2ec16b9b-f9e5-4039-8e94-cbbbcb91a7ee_77d7b876-8f8c-41f3-90ae-2e213c49ec24.html,,,,,, "1-Octanol, reaction products with phosphorus oxide (P2O5), potassium salts",111062-42-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f6fa768-d0ab-4407-bef5-806dd699a4c3/documents/2ec16b9b-f9e5-4039-8e94-cbbbcb91a7ee_77d7b876-8f8c-41f3-90ae-2e213c49ec24.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "1-Octanol, reaction products with phosphorus oxide (P2O5), potassium salts",111062-42-1," The oral LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight.   Not scientifically necessary to conduct in vivo acute dermal or acute inhalation studies. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f6fa768-d0ab-4407-bef5-806dd699a4c3/documents/4638992f-d4ea-49a8-807f-b67a4de5dc21_77d7b876-8f8c-41f3-90ae-2e213c49ec24.html,,,,,, "1-Octanol, reaction products with phosphorus oxide (P2O5), potassium salts",111062-42-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f6fa768-d0ab-4407-bef5-806dd699a4c3/documents/4638992f-d4ea-49a8-807f-b67a4de5dc21_77d7b876-8f8c-41f3-90ae-2e213c49ec24.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 1-oxa-4-azaspiro[4.5]decan-4-ethanol,2359-11-7," HEOX-CN (CAS 2359 -11 -7) was administered by oral gavage to five rats of each sex per group, at 2000 mg/kg body weight. Animals were subjected to daily observations, and body weight determinations weekly and at death. Macroscopic examination was performed on the day of death or at the end of the experimental period (day 15). Clinical signs of toxicity were observed in all animals on the day of treatment. The severity and number of symptoms were increased in the females. From day 6 onwards, signs of toxicity were again observed in three females, resulting in the death of one animal on day 9. The symptoms had completely disappeared by day 14 in the other two animals. Enlarged kidneys were found in one of the latter females at macroscopic post mortem examination. Body weight loss or reduced body weight gain were observed in these three females over the first week. The sensitivity of the females to HEOX-CN after oral administration appeared to be higher than in the males. The oral L050 value of HEOX-CN in rats was established as exceeding 2000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46d6ab85-ff03-467b-a7ae-8e61b5f5b590/documents/IUC5-e3cd20df-0b87-4c4f-a6f5-75f7d527a664_a2b970c9-5e13-4d8d-9fa2-1ae335ca3504.html,,,,,, 1-oxa-4-azaspiro[4.5]decan-4-ethanol,2359-11-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46d6ab85-ff03-467b-a7ae-8e61b5f5b590/documents/IUC5-e3cd20df-0b87-4c4f-a6f5-75f7d527a664_a2b970c9-5e13-4d8d-9fa2-1ae335ca3504.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, 1-phenyl-3-pyrazolidone,92-43-3," Repeated dose toxicity: Oral The toxicity of test substance was tested in rats by oral exposure for 17 weeks at the dose concentration of 0, 50, 250 or 500 mg/kg bw. No adverse effects were observed at dose range of 300-500 mg/kg/day.   Repeated dose toxicity: inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 1-phenyl-3-pyrazolidone (92-43-3), which is reported as 0.00944 Pa. Also considering the particle size distribution of the substance the majority of the particles were found to be in the size of 150 micrometer which is much larger size range compared to the inhalable particu late matter. Thus, exposure to inhalable dust, mist and vapour of the chemical 1-hydroxybenzotriazole is highly unlikely. Therefore this study is considered for waiver.   Repeated dose toxicity: dermal The acute toxicity value for 1-phenyl-3-pyrazolidone (92-43-3) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 1-phenyl-3-pyrazolidone shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 1-phenyl-3-pyrazolidone shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/766cb885-fa94-45fe-a822-131b38e33790/documents/723f744f-f709-45f8-997a-565a173b700c_44d70c31-1ab6-4830-944b-30735550ca3f.html,,,,,, 1-phenyl-3-pyrazolidone,92-43-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/766cb885-fa94-45fe-a822-131b38e33790/documents/723f744f-f709-45f8-997a-565a173b700c_44d70c31-1ab6-4830-944b-30735550ca3f.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat 1-phenyl-3-pyrazolidone,92-43-3," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value was considered in between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.002173155 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/766cb885-fa94-45fe-a822-131b38e33790/documents/687518ec-992c-4219-a9c5-3a60273c46d8_44d70c31-1ab6-4830-944b-30735550ca3f.html,,,,,, 1-phenyl-3-pyrazolidone,92-43-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/766cb885-fa94-45fe-a822-131b38e33790/documents/687518ec-992c-4219-a9c5-3a60273c46d8_44d70c31-1ab6-4830-944b-30735550ca3f.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, 1-phenyl-3-pyrazolidone,92-43-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/766cb885-fa94-45fe-a822-131b38e33790/documents/687518ec-992c-4219-a9c5-3a60273c46d8_44d70c31-1ab6-4830-944b-30735550ca3f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-phenyldecane-1,3-dione",68892-13-7," In a GLP-compliant OECD Test guideline 422 study performed in rats, the registered substance 1 -phenyldecane-1,3 -dione administered by oral gavage at dose levels of 100, 300 and 1000 mg/kg/day induced no adverse effects up to the highest dose level. The No Observed Adverse Effect Level (NOAEL) was therefore 1000 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73bf9998-9a98-465c-9062-3188ed8b8be4/documents/a6fc6552-77ba-4117-8a10-95e495034fa1_7330d444-ce51-4bd4-a18c-14590bf38665.html,,,,,, "1-phenyldecane-1,3-dione",68892-13-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73bf9998-9a98-465c-9062-3188ed8b8be4/documents/a6fc6552-77ba-4117-8a10-95e495034fa1_7330d444-ce51-4bd4-a18c-14590bf38665.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1-phenyldecane-1,3-dione",68892-13-7," Oral: LD50: > 2,000 mg/kg for rat (limit test, OECD 401 and GLPs compliant) Dermal: LD50: > 2,000 mg/kg for rat (limit test, OECD 402 and GLPs compliant) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73bf9998-9a98-465c-9062-3188ed8b8be4/documents/039e3ba8-946d-4b05-b5ff-396e1384c919_7330d444-ce51-4bd4-a18c-14590bf38665.html,,,,,, "1-phenyldecane-1,3-dione",68892-13-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73bf9998-9a98-465c-9062-3188ed8b8be4/documents/039e3ba8-946d-4b05-b5ff-396e1384c919_7330d444-ce51-4bd4-a18c-14590bf38665.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1-phenyldecane-1,3-dione",68892-13-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73bf9998-9a98-465c-9062-3188ed8b8be4/documents/039e3ba8-946d-4b05-b5ff-396e1384c919_7330d444-ce51-4bd4-a18c-14590bf38665.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N-(2,6-dimethylphenyl)-2-(piperazin-1-yl)acetamide",5294-61-1,The product is classified: Acute Tox. 4 H302 Route: Oral - Species: Rat - OECD Guideline 420 (GLP study) - The dose of 2000 mg/kg bw caused death in the sighting study. No effects were observed at 300 mg/kg bw (main study). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e41d0a8-52d7-4f79-996f-e105d1e8d0f8/documents/108963a9-a2a9-47a2-9f4b-39fe6d33540f_f47343c6-f056-4497-8a91-765b272acee6.html,,,,,, "N-(2,6-dimethylphenyl)-2-(piperazin-1-yl)acetamide",5294-61-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e41d0a8-52d7-4f79-996f-e105d1e8d0f8/documents/108963a9-a2a9-47a2-9f4b-39fe6d33540f_f47343c6-f056-4497-8a91-765b272acee6.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "2-hydroxy-N,N,N-trimethyl-3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)thio]-1-propanimium chloride",88992-45-4,"The test substance was administered by dermal route at dose levels 175, 350 and 700 mg.Kg-1 to 60 rats during 21 days, it can cause adverse systemic effects to the test systems at doses 350 and 700 mg.Kg-1, the NOAEL was equal than 175 mg/Kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5426aa7c-4a82-4a18-bb4d-3e561f1da39d/documents/27be5300-5ec8-4eda-8fa5-d85c14c6b93b_a1e0c0e7-3b6a-4b79-952d-bc246975c584.html,,,,,, "2-hydroxy-N,N,N-trimethyl-3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)thio]-1-propanimium chloride",88992-45-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5426aa7c-4a82-4a18-bb4d-3e561f1da39d/documents/27be5300-5ec8-4eda-8fa5-d85c14c6b93b_a1e0c0e7-3b6a-4b79-952d-bc246975c584.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,175 mg/kg bw/day,,rat "2-hydroxy-N,N,N-trimethyl-3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)thio]-1-propanimium chloride",88992-45-4,"In acute oral toxicity study, the LD50 in female rats is greater than 300 mg/kg bw but less than 2000 mg/kg bw.In acute dermal toxicity study in rat, the LD50 was greater than 2000 mg/kg bw.In the acute inhalation toxicity test in rats, the LD50 was estimated as 0.16 mg/L. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5426aa7c-4a82-4a18-bb4d-3e561f1da39d/documents/8c2818a1-29fe-4692-8d55-f4716306682e_a1e0c0e7-3b6a-4b79-952d-bc246975c584.html,,,,,, "2-hydroxy-N,N,N-trimethyl-3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)thio]-1-propanimium chloride",88992-45-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5426aa7c-4a82-4a18-bb4d-3e561f1da39d/documents/8c2818a1-29fe-4692-8d55-f4716306682e_a1e0c0e7-3b6a-4b79-952d-bc246975c584.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "2-hydroxy-N,N,N-trimethyl-3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)thio]-1-propanimium chloride",88992-45-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5426aa7c-4a82-4a18-bb4d-3e561f1da39d/documents/8c2818a1-29fe-4692-8d55-f4716306682e_a1e0c0e7-3b6a-4b79-952d-bc246975c584.html,,inhalation,LC50,160 mg/m3,adverse effect observed, "1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts",91648-19-0," An OECD 422 study is available with 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts.In this study the No Observed Adverse Effect Level (NOAEL) for parental toxicity was considered to be 100 mg/kg/day based on microscopic findings in the forestomach, lungs, trachea and kidneys of animals given 300 mg/kg/day. ECHA have agreed that a 90-day oral repeated dose study can be conduced with 1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C8 18 acyl derivs., hydroxides, inner salts. This study will be used to address the endpoint for the target substance. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7922f3f-234b-48a9-b83b-90bd6314c98b/documents/b48e1626-c67c-48c1-b6be-0f46cb048cb7_21ec8d22-3ab2-4a34-b998-145dcada1f99.html,,,,,, "1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts",91648-19-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7922f3f-234b-48a9-b83b-90bd6314c98b/documents/b48e1626-c67c-48c1-b6be-0f46cb048cb7_21ec8d22-3ab2-4a34-b998-145dcada1f99.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts",91648-19-0," An acute oral toxicity study is available for the submission substance [Propanaminium, N-(3 -aminopropyl)-2 -hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-14(even numbered) acyl) derivs., hydroxides, inner salts]; a supporting study with the read-across (analogue) substance [Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-(C12-18 (even numbered) acyl) derivs., hydroxides, inner salts] is also available. Both studies report acute oral LD50 values of >2000 mg/kg bw. A waiver is provided for acute inhalation toxicity based on exposure considerations. An acute dermal toxicity study is available for the submission substance. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7922f3f-234b-48a9-b83b-90bd6314c98b/documents/c65e0569-ea4e-4e88-94db-d66fc363d9de_21ec8d22-3ab2-4a34-b998-145dcada1f99.html,,,,,, "1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts",91648-19-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7922f3f-234b-48a9-b83b-90bd6314c98b/documents/c65e0569-ea4e-4e88-94db-d66fc363d9de_21ec8d22-3ab2-4a34-b998-145dcada1f99.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1-Propanaminium, N-(3-aminopropyl)-2-hydroxy-N,N-dimethyl-3-sulfo-, N-C12-14 acyl derivs., hydroxides, inner salts",91648-19-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7922f3f-234b-48a9-b83b-90bd6314c98b/documents/c65e0569-ea4e-4e88-94db-d66fc363d9de_21ec8d22-3ab2-4a34-b998-145dcada1f99.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "sodium 2-methyl-2-({3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)thio]propanoyl}amino)propane-1-sulfonate",62880-93-7, The substance was tested at limit dose level (1000 mg/Kg) to rats by dermal route for 28 days. No adverse systemic effects or local response in the skin (epidermal) were observed. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d3398f3-4f6a-460e-836f-4e653f533c31/documents/123ca46c-9f77-4a3f-8c4d-86c7d231cdb3_1bc2895b-6f7b-4e16-a34d-e69265c2e08c.html,,,,,, "sodium 2-methyl-2-({3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)thio]propanoyl}amino)propane-1-sulfonate",62880-93-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d3398f3-4f6a-460e-836f-4e653f533c31/documents/123ca46c-9f77-4a3f-8c4d-86c7d231cdb3_1bc2895b-6f7b-4e16-a34d-e69265c2e08c.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "sodium 2-methyl-2-({3-[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)thio]propanoyl}amino)propane-1-sulfonate",62880-93-7," Studies on acute toxicity by oral, inhalation and dermal were conducted at limit dose level, no adverse effects observed. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d3398f3-4f6a-460e-836f-4e653f533c31/documents/840aca06-a698-4825-a7a2-b895b6e95189_1bc2895b-6f7b-4e16-a34d-e69265c2e08c.html,,,,,, "1-Propanesulfonic acid, 3-(cyclohexylamino)-2-hydroxy-, monosodium salt",102601-34-3, The acute toxicity of the test item was determined in a GLP-study according to OECD Test Guideline 423 as LD50 > 2000 mg/kg bw (reference 7.2.1 -1). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06036166-9cbe-4db2-b307-936341b77016/documents/b5011be0-66dd-475a-a27d-b9e3386b77e9_4e7091e4-0050-41ed-a67f-f1a3f815d43a.html,,,,,, "1-Propanesulfonic acid, 3-(cyclohexylamino)-2-hydroxy-, monosodium salt",102601-34-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06036166-9cbe-4db2-b307-936341b77016/documents/b5011be0-66dd-475a-a27d-b9e3386b77e9_4e7091e4-0050-41ed-a67f-f1a3f815d43a.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Reaction products of 3-(trimethoxysilyl)propane-1-thiol and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane (1:1).",117172-56-2,"  OECD 422, GLP, reliability 1, inhalation, rat: NOAEC systemic toxicity>= 10 mg/m3 NOAEC local toxicity < 0.25 mg/m3 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd3ba001-3ab2-4a23-8546-0b13bd93f23e/documents/f4c7551e-fe55-44e2-8e87-3f7fffc99b2a_9d2cb598-c417-4c14-bb9b-1569af3d6e40.html,,,,,, "Reaction products of 3-(trimethoxysilyl)propane-1-thiol and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane (1:1).",117172-56-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd3ba001-3ab2-4a23-8546-0b13bd93f23e/documents/f4c7551e-fe55-44e2-8e87-3f7fffc99b2a_9d2cb598-c417-4c14-bb9b-1569af3d6e40.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,>= 10 mg/m3,,rat "Reaction products of 3-(trimethoxysilyl)propane-1-thiol and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane (1:1).",117172-56-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd3ba001-3ab2-4a23-8546-0b13bd93f23e/documents/f4c7551e-fe55-44e2-8e87-3f7fffc99b2a_9d2cb598-c417-4c14-bb9b-1569af3d6e40.html,Repeated dose toxicity – local effects,inhalation,LOAEC,0.25 mg/m3,adverse effect observed,rat "Reaction products of 3-(trimethoxysilyl)propane-1-thiol and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane (1:1).",117172-56-2,"OECD423, oral, rat, GLP, Klimisch reliability 1: LD50 > 2000 mg/kg bw OECD402, dermal, rat, GLP, Klimisch reliability 1: LD50 > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd3ba001-3ab2-4a23-8546-0b13bd93f23e/documents/IUC5-22d53bcb-588b-48b0-a427-1d4eaab9734a_9d2cb598-c417-4c14-bb9b-1569af3d6e40.html,,,,,, "Reaction products of 3-(trimethoxysilyl)propane-1-thiol and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane (1:1).",117172-56-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd3ba001-3ab2-4a23-8546-0b13bd93f23e/documents/IUC5-22d53bcb-588b-48b0-a427-1d4eaab9734a_9d2cb598-c417-4c14-bb9b-1569af3d6e40.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Reaction products of 3-(trimethoxysilyl)propane-1-thiol and 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethylcyclohexane (1:1).",117172-56-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd3ba001-3ab2-4a23-8546-0b13bd93f23e/documents/IUC5-22d53bcb-588b-48b0-a427-1d4eaab9734a_9d2cb598-c417-4c14-bb9b-1569af3d6e40.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 3-(dimethylamino)-1-propanol hydrochloride,117829-74-0,"oral: LD50 > 2000 mg/kg (male/female), OECD Guideline Study 423 (BASF 2001 (10A0616/001099) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbf097a8-1101-445e-afd5-3395ab41f8f7/documents/IUC5-2bcfdfca-6382-4fa6-bba9-9ba1873338a6_e9107b43-070f-4a61-b5b3-623a72e3ffbf.html,,,,,, "3-((5-(3-Acetoxy-2,2-dimethylpropylideneamino)-1,3,3-trimethylcyclohexyl)methylimino)-2,2-dimethylpropyl acetate",1064082-81-0,"Under the conditions of an OECD 422 compliant study, the test item caused signs of systemic toxicity in male and female Hsd.Han: Wistar rats at 1000 mg/kg bw/day administered by oral gavage. As a consequence, an influence on the estrous cycle, delivery data of dams (higher pre-implantation loss, lower birth mean), reproductive performance of male and female animals (prolonged pre-coital and conceiving periods) were also observed at 1000 mg/kg bw/day. The development of the F1 offspring was also impaired at 1000 mg/kg bw/day due to poor general condition of the dams at this dose level: clinical signs with higher incidence, higher mortality and reduced body weight gain and body weight were observed with respect to their control. Based on these observations the No Observed Adverse Effect Levels (NOAELs) were determined as follows:   NOAEL for systemic toxicity of male and female rats: 300 mg/kg bw/day NOAEL for reproductive performance of male/female rats: 300 mg/kg bw/day NOAEL for F1 Offspring: 300 mg/kg bw/day Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP and guideline conform study. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dacaae19-cbdf-466c-b10f-e201c9f78817/documents/a144f851-a18f-442e-a8c5-e75b7010c0c1_854b706b-4e4d-42b0-8bb7-4b21abe237c9.html,,,,,, "3-((5-(3-Acetoxy-2,2-dimethylpropylideneamino)-1,3,3-trimethylcyclohexyl)methylimino)-2,2-dimethylpropyl acetate",1064082-81-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dacaae19-cbdf-466c-b10f-e201c9f78817/documents/a144f851-a18f-442e-a8c5-e75b7010c0c1_854b706b-4e4d-42b0-8bb7-4b21abe237c9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "3-((5-(3-Acetoxy-2,2-dimethylpropylideneamino)-1,3,3-trimethylcyclohexyl)methylimino)-2,2-dimethylpropyl acetate",1064082-81-0,"In an acute oral toxicity study in rats according to OECD guideline 423, the determined LD50 was greater than 2084 mg/kg bw (LD50 ≥ 2084 mg/kg bw). In an acute dermal toxicity study with rats according to OECD guideline 402, the LD50 was determined to be greater than 2000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP and guideline compliant study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): GLP and guideline study ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dacaae19-cbdf-466c-b10f-e201c9f78817/documents/IUC5-9a70ebd0-b8a2-41c9-bfb4-a36472d297e3_854b706b-4e4d-42b0-8bb7-4b21abe237c9.html,,,,,, "3-((5-(3-Acetoxy-2,2-dimethylpropylideneamino)-1,3,3-trimethylcyclohexyl)methylimino)-2,2-dimethylpropyl acetate",1064082-81-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dacaae19-cbdf-466c-b10f-e201c9f78817/documents/IUC5-9a70ebd0-b8a2-41c9-bfb4-a36472d297e3_854b706b-4e4d-42b0-8bb7-4b21abe237c9.html,,oral,discriminating dose,"2,084 mg/kg bw",no adverse effect observed, "3-((5-(3-Acetoxy-2,2-dimethylpropylideneamino)-1,3,3-trimethylcyclohexyl)methylimino)-2,2-dimethylpropyl acetate",1064082-81-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dacaae19-cbdf-466c-b10f-e201c9f78817/documents/IUC5-9a70ebd0-b8a2-41c9-bfb4-a36472d297e3_854b706b-4e4d-42b0-8bb7-4b21abe237c9.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3,5-dihydroxy-4-[3-(4-hydroxyphenyl)propanoyl]phenyl 2-O-(6-deoxy-α-Dmannopyranosyl)-β-D-gulopyranoside",18916-17-1,"LD50 (rat), oral:   > 2000 mg/kg b.w.   (OECD 423 / EC B.1, GLP); limit test ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9147d4a8-1dcc-473e-9dd5-e2925f0ae614/documents/IUC5-1825d90c-30ef-47c5-a778-1cf4495427a3_f49a2bc8-c36f-4f03-9c7d-12b87cf18b3f.html,,,,,, "2-bromo-3,3,3-trifluoroprop-1-ene",1514-82-5,"In this 90 day study, the NOAEL was considered to be 199 ppm (eq. 1424.90 mg/m3) based on chronic heart inflammation, clinical signs and histopathological changes related to irritation of the respiratory tract, CNS effects and histopathological changes seen in the liver, pancreas, spleen and thymus. Following the 4 week recovery period, there was partial or complete recovery of all toxic effects.   ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/978f9160-79f0-4764-87b4-d00ecc454766/documents/IUC5-68ed6e36-c754-49ae-a1a8-710fd30953cb_0ac5be29-3dd7-4697-a534-d31f0e3e529e.html,,,,,, "2-bromo-3,3,3-trifluoroprop-1-ene",1514-82-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/978f9160-79f0-4764-87b4-d00ecc454766/documents/IUC5-68ed6e36-c754-49ae-a1a8-710fd30953cb_0ac5be29-3dd7-4697-a534-d31f0e3e529e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,424.9 mg/m3",,rat "2-bromo-3,3,3-trifluoroprop-1-ene",1514-82-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/978f9160-79f0-4764-87b4-d00ecc454766/documents/IUC5-68ed6e36-c754-49ae-a1a8-710fd30953cb_0ac5be29-3dd7-4697-a534-d31f0e3e529e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,423.9 mg/m3",adverse effect observed,rat "2-bromo-3,3,3-trifluoroprop-1-ene",1514-82-5,"LC50, Inhalation, 4 hours (rat) = 11726 ppm   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/978f9160-79f0-4764-87b4-d00ecc454766/documents/IUC5-bd2b5bce-9043-4e1d-b4a0-7e1f580adf45_0ac5be29-3dd7-4697-a534-d31f0e3e529e.html,,,,,, "2-bromo-3,3,3-trifluoroprop-1-ene",1514-82-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/978f9160-79f0-4764-87b4-d00ecc454766/documents/IUC5-bd2b5bce-9043-4e1d-b4a0-7e1f580adf45_0ac5be29-3dd7-4697-a534-d31f0e3e529e.html,,inhalation,LC50,"83,900 mg/m3",adverse effect observed, 2-Chlor-3-isothiocyanato-1-propene,14214-31-4,"Acute oral toxicity, rat, OECD 423: LD50 >30 <50 mg/kg Acute inhalation toxicity, rat, OECD 403: LC50 =0.152 mg/L ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f40defb2-9650-4e97-8c5b-aa61bb4862cf/documents/89c1ff78-257a-46f7-8f1f-4b263ee298f3_c7af941a-5958-4025-9277-f9330112cf15.html,,,,,, 2-Chlor-3-isothiocyanato-1-propene,14214-31-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f40defb2-9650-4e97-8c5b-aa61bb4862cf/documents/89c1ff78-257a-46f7-8f1f-4b263ee298f3_c7af941a-5958-4025-9277-f9330112cf15.html,,oral,LD50,> 30 mg/kg bw,adverse effect observed, 2-Chlor-3-isothiocyanato-1-propene,14214-31-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f40defb2-9650-4e97-8c5b-aa61bb4862cf/documents/89c1ff78-257a-46f7-8f1f-4b263ee298f3_c7af941a-5958-4025-9277-f9330112cf15.html,,inhalation,LC50,ca.0.152 mg/L,adverse effect observed, "2-methylprop-1-ene, pentamer",42278-27-3,"There is a 28 day repeat oral dosing study with triisobutylene with 14 day recovery. There are also repeat dose toxicity studies with other higher olefins spanning the range C8 to C20. The data for these studies indicate that the location of the double bond or the addition of branching to the structure do not appear to affect the toxicity. Higher olefins are of low toxicity in rats. Male rat kidney effects indicative of alpha-2u-globulin nephropathy consistently occur with the C8 to C14 higher olefins. Alpha-2u-globulin nephropathy is considered to be male rat-specific and is not relevant for humans. Treatment-related liver effects (increased organ weights, hepatocyte cytoplasmic vacuolation, and centrilobular hepatocyte hypertrophy) are also observed in rats exposed to higher olefins, which may reflect adaptive changes as a result of the high liver burden of these substances. There is no evidence of neurotoxicity. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08fa17b6-2abc-4c6e-8daf-6c3c3893eede/documents/e34248d0-0464-4f42-a6f2-c212ba496f06_20938635-a1de-4623-b4cb-9a535e5be97b.html,,,,,, "2-methylprop-1-ene, pentamer",42278-27-3,"Acute toxicity studies exist for higher olefins including butylene oligomers at both ends of the carbon number ranges within this category. The results are consistent throughout the category and indicate low acute toxicity by the oral, dermal and inhalation routes of exposure. Butylene oligomers have low kinematic viscosity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08fa17b6-2abc-4c6e-8daf-6c3c3893eede/documents/8ceef6fc-85ad-4d15-81a3-8350f75b75b0_20938635-a1de-4623-b4cb-9a535e5be97b.html,,,,,, "1-propyl-4-[(trans,trans)-4'-propyl[1,1'-bicyclohexyl]-4-yl]-benzene",84656-77-9, OECD 401: LD50 > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa60e6d6-d0a9-4390-9b98-4b0e1e18b236/documents/3f85b961-b95b-4636-b5f5-b13db72bb5cf_8d2a4df4-8858-4e8d-97b4-d49984f7b7b3.html,,,,,, "1-propyl-4-[(trans,trans)-4'-propyl[1,1'-bicyclohexyl]-4-yl]-benzene",84656-77-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa60e6d6-d0a9-4390-9b98-4b0e1e18b236/documents/3f85b961-b95b-4636-b5f5-b13db72bb5cf_8d2a4df4-8858-4e8d-97b4-d49984f7b7b3.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N,N,N-trimethyltetradecan-1-aminium oxalate",154858-16-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable without restrictions. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb790d6e-d2b6-4d0c-a1df-a2e9ab90adee/documents/IUC5-99c4c3b4-58d9-45d1-b4eb-6a916a71e40d_84d25864-7112-453b-8896-f210b3f7744b.html,,,,,, "N,N,N-trimethyltetradecan-1-aminium oxalate",154858-16-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb790d6e-d2b6-4d0c-a1df-a2e9ab90adee/documents/IUC5-99c4c3b4-58d9-45d1-b4eb-6a916a71e40d_84d25864-7112-453b-8896-f210b3f7744b.html,,oral,discriminating dose,500 mg/kg bw,adverse effect observed, "N,N,N-trimethyltetradecan-1-aminium methylcarbonate",126437-91-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable without restrictions. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/859556f7-6a4a-40f7-abbe-8f37c607bf97/documents/IUC5-bc256309-aad7-4789-8a9d-c018008e75ec_cca83643-2009-4869-a990-caeffe9b9476.html,,,,,, "N,N,N-trimethyltetradecan-1-aminium methylcarbonate",126437-91-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/859556f7-6a4a-40f7-abbe-8f37c607bf97/documents/IUC5-bc256309-aad7-4789-8a9d-c018008e75ec_cca83643-2009-4869-a990-caeffe9b9476.html,,oral,discriminating dose,500 mg/kg bw,adverse effect observed, "Oligomerisation products of 1-tetradecene and 1-dodecene, hydrogenated, C24-84 fraction",883233-93-0," Four read-across 28-day oral exposure studies (OECD 407/422) and three 90-day oral exposure studies (OECD 408/OECD 415) were identified either within category or from a structural analogue. There were no key dermal or inhalation repeated dose studies identified. Overall, the 28-day exposure studies found no toxicity when the respective poly alpha olefins were administered orally. Results were as follows. ·    The NOAEL is 6245 mg/kg/day in male rats and 6771 mg/kg/day in female rats for the 28-day oral repeated dose study from 1-decene, homopolymer, hydrogenated. ·    The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1-dodecene dimer with 1-decene, hydrogenated. ·    The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1 -dodecene, trimer. ·    The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1-dodecene, dimer. For the 90-day oral exposure studies, results were as follows. • The NOAEL is 4145.4 mg/kg bw in male rats and 4619.9 mg/kg bw in female rats for the 90-day exposure study from 1-decene, homopolymer, hydrogenated. • The NOAEL is 1000 mg/kg bw in male and female rats for the 91-day exposure study from 1-decene, homopolymer, hydrogenated. • The NOAEL is 1000 mg/kg bw in male and female rats for the 90-day one-generation reproduction study with subchronic toxicity from 1 -dodecene, trimer. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c6ff45d-cc13-4eec-ba69-0873ba29d7a3/documents/99e8738b-e983-416f-a736-01b102ebd53d_d8c5e9f9-2453-422a-b8cb-0ead7ee68dd3.html,,,,,, "Oligomerisation products of 1-tetradecene and 1-dodecene, hydrogenated, C24-84 fraction",883233-93-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c6ff45d-cc13-4eec-ba69-0873ba29d7a3/documents/99e8738b-e983-416f-a736-01b102ebd53d_d8c5e9f9-2453-422a-b8cb-0ead7ee68dd3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Oligomerisation products of 1-tetradecene and 1-dodecene, hydrogenated, C24-84 fraction",883233-93-0,"One key acute oral toxicity studies (16 CFR 1500) and one key acute dermal toxicity study (OECD 402) were identified. Additional read-across studies were identified for numerous poly alpha olefins that showed similar acute oral and dermal toxicity results. Eight key acute inhalation studies (OECD 403) were identified for poly alpha olefins; four of which were for dec-1-ene, dimers, hydrogenated. • The oral LD50 was > 5000 mg/kg bw in male and female rats for dec-1-ene, dimers, hydrogenated; 1-dodecene dimer with 1-decene, hydrogenated; 1-decene trimer, hydrogenated and tetramers; 1-decene, homopolymer, hydrogenated; 1 -dodecene, trimer; and 1 -dodcene, polymer with 1 -decene.• The oral LD50 was > 2000 mg/kg bw in male and female rats for decene trimer hydrogenated.• The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for dec-1-ene, dimers, hydrogenated.• The dermal LD50 was > 2000 mg/kg/bw in male and female rats for both 1 -dodecene dimer with 1 -decene, hydrogenated; 1 -dodecene dimer with 1 -decene, hydrogenated;1 -dodecene, trimer; and 1 -dodecene, polymer with 1 -decene. • The inhalation LC50 values for dec-1 -ene, dimers, hydrogenated in male and female rats were all reported as < 5.0 mg/L.• Dec-1-ene, dimers, hydrogenated is classified for aspiration toxicity based on its kinematic viscosity at 40°C. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c6ff45d-cc13-4eec-ba69-0873ba29d7a3/documents/52bb3c38-3146-45ac-ae60-fd9d5f38ea66_d8c5e9f9-2453-422a-b8cb-0ead7ee68dd3.html,,,,,, "Oligomerisation products of 1-tetradecene and 1-dodecene, hydrogenated, C36-84 fraction",883233-91-8," Four read-across 28-day oral exposure studies (OECD 407/422) and three 90-day oral exposure studies (OECD 408/OECD 415) were identified either within category or from a structural analogue. There were no key dermal or inhalation repeated dose studies identified. Overall, the 28-day exposure studies found no toxicity when the respective poly alpha olefins were administered orally. Results were as follows. ·    The NOAEL is 6245 mg/kg/day in male rats and 6771 mg/kg/day in female rats for the 28-day oral repeated dose study from 1-decene, homopolymer, hydrogenated. ·    The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1-dodecene dimer with 1-decene, hydrogenated. ·    The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1 -dodecene, trimer. ·    The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1-dodecene, dimer. For the 90-day oral exposure studies, results were as follows. • The NOAEL is 4145.4 mg/kg bw in male rats and 4619.9 mg/kg bw in female rats for the 90-day exposure study from 1-decene, homopolymer, hydrogenated. • The NOAEL is 1000 mg/kg bw in male and female rats for the 91-day exposure study from 1-decene, homopolymer, hydrogenated. • The NOAEL is 1000 mg/kg bw in male and female rats for the 90-day one-generation reproduction study with subchronic toxicity from 1 -dodecene, trimer. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c738dd0-47de-48a3-9f10-2eabcdba0b4a/documents/99e8738b-e983-416f-a736-01b102ebd53d_04cc03fc-4c0d-466f-82aa-54b2b146d2b5.html,,,,,, "Oligomerisation products of 1-tetradecene and 1-dodecene, hydrogenated, C36-84 fraction",883233-91-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c738dd0-47de-48a3-9f10-2eabcdba0b4a/documents/99e8738b-e983-416f-a736-01b102ebd53d_04cc03fc-4c0d-466f-82aa-54b2b146d2b5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Oligomerisation products of 1-tetradecene and 1-dodecene, hydrogenated, C36-84 fraction",883233-91-8,"One key acute oral toxicity studies (16 CFR 1500) and one key acute dermal toxicity study (OECD 402) were identified. Additional read-across studies were identified for numerous poly alpha olefins that showed similar acute oral and dermal toxicity results. Eight key acute inhalation studies (OECD 403) were identified for poly alpha olefins; four of which were for dec-1-ene, dimers, hydrogenated. • The oral LD50 was > 5000 mg/kg bw in male and female rats for dec-1-ene, dimers, hydrogenated; 1-dodecene dimer with 1-decene, hydrogenated; 1-decene trimer, hydrogenated and tetramers; 1-decene, homopolymer, hydrogenated; 1 -dodecene, trimer; and 1 -dodcene, polymer with 1 -decene.• The oral LD50 was > 2000 mg/kg bw in male and female rats for decene trimer hydrogenated.• The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for dec-1-ene, dimers, hydrogenated.• The dermal LD50 was > 2000 mg/kg/bw in male and female rats for both 1 -dodecene dimer with 1 -decene, hydrogenated; 1 -dodecene dimer with 1 -decene, hydrogenated;1 -dodecene, trimer; and 1 -dodecene, polymer with 1 -decene. • The inhalation LC50 values for dec-1 -ene, dimers, hydrogenated in male and female rats were all reported as < 5.0 mg/L.• Dec-1-ene, dimers, hydrogenated is classified for aspiration toxicity based on its kinematic viscosity at 40°C. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c738dd0-47de-48a3-9f10-2eabcdba0b4a/documents/52bb3c38-3146-45ac-ae60-fd9d5f38ea66_04cc03fc-4c0d-466f-82aa-54b2b146d2b5.html,,,,,, "2-({[3-(isocyanatomethyl)-3,5,5-trimethylcyclohexyl]carbamoyl}oxy)ethyl prop-2-enoate",124451-79-2,"The test substance is of low oral acute toxicity with an oral LD50 ( rat) of > 2000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is valid without restriction (Klimisch 1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/790726de-0c9d-4720-a500-21348187eaa9/documents/b54bd9c7-b6d7-4795-89ea-898b7904aeb4_c851bad6-9ffe-4c89-9dd5-6983a9bea6a4.html,,,,,, "2-({[3-(isocyanatomethyl)-3,5,5-trimethylcyclohexyl]carbamoyl}oxy)ethyl prop-2-enoate",124451-79-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/790726de-0c9d-4720-a500-21348187eaa9/documents/b54bd9c7-b6d7-4795-89ea-898b7904aeb4_c851bad6-9ffe-4c89-9dd5-6983a9bea6a4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-({[3-(methylsulfanyl)phenyl]carbamoyl}oxy)ethyl prop-2-enoate,1207339-61-4,Data is neither required nor available. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1415e553-19f1-4c4e-ab3c-46f75c01e8e4/documents/IUC5-0afe6edb-375c-48d1-b8bb-2b32ff6e7110_f3755205-d9d1-4c12-9e39-80eaeedce738.html,,,,,, "2-({3-(octadecanoyloxy)-2,2-bis[(octadecanoyloxy)methyl]propoxy}methyl)-2-[(octadecanoyloxy)methyl]propane-1,3-diyl dioctadecanoate",70969-57-2,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.   Oral (OECD 407, GLP, rat): NOAEL ≥ 1000 mg/kg bw/day Read-across from structural analogue source substances Dipentaerythritol hexaesters with fatty acids, C5 and C9iso (CAS No. 647028-25-9), Pentaerythritol tetraesters of n-decanoic, n-heptanoic, n-octanoic and n-valeric acids (CAS No. 68424-31-7), and Fatty acids, C8-10 mixed esters with dipentaerythritol, isooctanoic acid, pentaerythritol and tripentaerythritol (CAS No. 189200-42-8) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprise adequate and reliable (Klimisch score 1 and 2) studies from various source substances with similar structures and intrinsic properties. Read-across is justified based on common precursors and hydrolysis products and consistent trends in environmental fate, ecotoxicological and toxicological profile. The selected studies are thus sufficient to fulfil the standard information requirements set out in Annexes VIII - X, 8.6, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55f81a72-1fc9-4316-9215-101608e1d43d/documents/9683dda1-7668-403d-938f-9fc4aa9837f3_ae357380-9734-45da-a34a-67bec3fa7b63.html,,,,,, "2-({3-(octadecanoyloxy)-2,2-bis[(octadecanoyloxy)methyl]propoxy}methyl)-2-[(octadecanoyloxy)methyl]propane-1,3-diyl dioctadecanoate",70969-57-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55f81a72-1fc9-4316-9215-101608e1d43d/documents/9683dda1-7668-403d-938f-9fc4aa9837f3_ae357380-9734-45da-a34a-67bec3fa7b63.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-({3-(octadecanoyloxy)-2,2-bis[(octadecanoyloxy)methyl]propoxy}methyl)-2-[(octadecanoyloxy)methyl]propane-1,3-diyl dioctadecanoate",70969-57-2,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.   Oral: LD50 > 2000 mg/kg bw Read-across from structural analogue source substances Pentaerythritol tetraoleate (CAS No. 19321-40-5), Fatty acids, C8-18 and C18-unsatd., esters with trimethylolpropane (CAS No. 85186-89-6), 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) (CAS No. 62125-22-8), and Fatty acids, C16-18 (even numbered), esters with pentaerythritol (CAS No. 85116-93-4)   Inhalation: LC50 > 5 mg/L air Read-across from structural analogue source substances Pentaerythritol tetraesters of n-decanoic, n-heptanoic, n-octanoic and n-valeric acids (CAS No. 68424-31-7) and Fatty acids, C5-9 tetraesters with pentaerythritol (CAS No. 67762-53-2)   Dermal (OECD 402, GLP): > 2000 mg/kg bw Read-across from structural analogue source substance Dipentaerythritol hexaesters with fatty acids, C5 and C9iso (CAS No. 647028-25-9) and 2,2-bis[[(1-oxoisooctadecyl)oxy]methyl]-1,3-propanediyl bis(isooctadecanoate) (CAS No. 62125-22-8) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate and reliable (Klimisch score 1 and 2) studies from various source substances with similar structures and intrinsic properties. Read-across is justified based on common precursors and hydrolysis products and consistent trends in environmental fate, ecotoxicological and toxicological profile. The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The available information comprises adequate and reliable (Klimisch score 1 and 2) studies from various source substances with similar structures and intrinsic properties. Read-across is justified based on common precursors and hydrolysis products and consistent trends in environmental fate, ecotoxicological and toxicological profile. The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate and reliable (Klimisch score 1 and 2) studies from various source substances with similar structures and intrinsic properties. Read-across is justified based on common precursors and hydrolysis products and consistent trends in environmental fate, ecotoxicological and toxicological profile. The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55f81a72-1fc9-4316-9215-101608e1d43d/documents/f70556c2-df2f-4c81-9681-af642825208c_ae357380-9734-45da-a34a-67bec3fa7b63.html,,,,,, "2-(1-(2-hydroxy-3,5-di-tert-pentyl-phenyl)ethyl)-4,6-di-tert-pentylphenyl acrylate",123968-25-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b2a6bac-cdaf-4a41-9859-7f0791a9b4be/documents/IUC5-55212154-fd89-42ac-8056-1c0a7f27dfbc_a83c61a3-798d-4b21-82b6-6021e0847218.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,430 mg/kg bw/day",,rat "2-(1-(2-hydroxy-3,5-di-tert-pentyl-phenyl)ethyl)-4,6-di-tert-pentylphenyl acrylate",123968-25-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b2a6bac-cdaf-4a41-9859-7f0791a9b4be/documents/IUC5-f3f84c37-eb16-4fda-81c5-c73f6e89bd14_a83c61a3-798d-4b21-82b6-6021e0847218.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-(1-(2-hydroxy-3,5-di-tert-pentyl-phenyl)ethyl)-4,6-di-tert-pentylphenyl acrylate",123968-25-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b2a6bac-cdaf-4a41-9859-7f0791a9b4be/documents/IUC5-f3f84c37-eb16-4fda-81c5-c73f6e89bd14_a83c61a3-798d-4b21-82b6-6021e0847218.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-(1,1-dimethylethyl)-6-[[3-(1,1-dimethylethyl)-2-hydroxy-5-methylphenyl]methyl]-4-methylphenyl acrylate",61167-58-6," NOAEL (oral, rat, subchronic) = 2193.3 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/876029aa-8e52-4a25-9d9b-cfc13c1cc265/documents/0e1769b9-d40b-4a2e-ae74-3840a347b7f3_27f987ab-3a8c-47ba-a4ca-c1b3de9204c7.html,,,,,, "2-(1,1-dimethylethyl)-6-[[3-(1,1-dimethylethyl)-2-hydroxy-5-methylphenyl]methyl]-4-methylphenyl acrylate",61167-58-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/876029aa-8e52-4a25-9d9b-cfc13c1cc265/documents/0e1769b9-d40b-4a2e-ae74-3840a347b7f3_27f987ab-3a8c-47ba-a4ca-c1b3de9204c7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,193 mg/kg bw/day",,rat "2-(1,1-dimethylethyl)-6-[[3-(1,1-dimethylethyl)-2-hydroxy-5-methylphenyl]methyl]-4-methylphenyl acrylate",61167-58-6, Oral: LD50 > 5000 mg/kg bw Dermal: LD50 > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/876029aa-8e52-4a25-9d9b-cfc13c1cc265/documents/0b871d80-f177-460f-8277-a22c298e08d4_27f987ab-3a8c-47ba-a4ca-c1b3de9204c7.html,,,,,, "2-(1,1-dimethylpropyl)phenol",3279-27-4,"The study has been performed to OECD guideline 407 principles, but GLP compliance is not stated. Well documented. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef7d9a20-7e83-46eb-85cc-e02b47e9beef/documents/4d7749ae-f1dd-44f2-bc41-529103d156ce_f126f89f-0fd9-48b0-8c95-65f4681d8d82.html,,,,,, "2-(1,1-dimethylpropyl)phenol",3279-27-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef7d9a20-7e83-46eb-85cc-e02b47e9beef/documents/4d7749ae-f1dd-44f2-bc41-529103d156ce_f126f89f-0fd9-48b0-8c95-65f4681d8d82.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2-(1,1-dimethylpropyl)phenol",3279-27-4,"One standard acute study rated Klimisch 1 (Safepharm) on substance. Four standard acute studies rated Klimisch 2 (Shell, Hazleton, Safepharm and Japanese Ministry of Health study) on a read across substance. One standard acute study rated Klimisch 2 (Shell) on read across substance. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef7d9a20-7e83-46eb-85cc-e02b47e9beef/documents/7ee906a1-6280-416c-b997-ae8ffc19b048_f126f89f-0fd9-48b0-8c95-65f4681d8d82.html,,,,,, "2-(1,1-dimethylpropyl)phenol",3279-27-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef7d9a20-7e83-46eb-85cc-e02b47e9beef/documents/7ee906a1-6280-416c-b997-ae8ffc19b048_f126f89f-0fd9-48b0-8c95-65f4681d8d82.html,,oral,LD50,789 mg/kg bw,adverse effect observed, "2-(1,1-dimethylpropyl)phenol",3279-27-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef7d9a20-7e83-46eb-85cc-e02b47e9beef/documents/7ee906a1-6280-416c-b997-ae8ffc19b048_f126f89f-0fd9-48b0-8c95-65f4681d8d82.html,,dermal,LD50,705 mg/kg bw,adverse effect observed, "2-(1,2-dichloro-1,2,2-trifluoroethoxy)-1,1,2,2-tetrafluoroethane-1-sulfonyl fluoride",144728-59-6, Acute toxicity via Oral route One reliable study with restrictions is available. The study was conducted on rats according a test method similar to the one described in OECD guideline No. 401. No mortality and no signs of significant toxic effects were observed. Fluorosulfonic Adduct showed an Approximate Lethal Dose (ALD) higher than 7500 mg/kg bw.   Acute toxicity via Dermal route No studies available. The assessment of Acute toxicity via Dermal route is done on the basis of physical and chemical properties and available data. Fluorosulfonic Adduct is not expected to have a LD50 (rat) lower or equal to 5000 mg/kg bw.   Acute toxicity via Inhalation route No studies available ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc01f58b-791b-4bf0-89c7-6dd2ec7b3e3b/documents/24b75605-4d72-44c2-a061-128e083cc735_e3fe7323-db89-43f1-9b36-3466130607d9.html,,,,,, "2-(1,2-dichloro-1,2,2-trifluoroethoxy)-1,1,2,2-tetrafluoroethane-1-sulfonyl fluoride",144728-59-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc01f58b-791b-4bf0-89c7-6dd2ec7b3e3b/documents/24b75605-4d72-44c2-a061-128e083cc735_e3fe7323-db89-43f1-9b36-3466130607d9.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)ethane-1-sulfonic acid-potassium (1/1)",91893-72-0," Oral: LD50(rat, f) > 2000 mg/kg bw (OECD 423, GLP) Dermal: no study available Inhalation: no study available ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3eec4ef6-5b84-458a-be22-714f2d9019c5/documents/362dcfe3-e40f-49fa-8611-4742506e6edc_081b82f7-0903-4f23-bdc0-7f623f9b301d.html,,,,,, "2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)ethane-1-sulfonic acid-potassium (1/1)",91893-72-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3eec4ef6-5b84-458a-be22-714f2d9019c5/documents/362dcfe3-e40f-49fa-8611-4742506e6edc_081b82f7-0903-4f23-bdc0-7f623f9b301d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)ethane-1-sulfonyl chloride",4403-36-5," Oral: LD50(rat, f) > 2000 mg/kg bw (OECD 423, GLP) Dermal: no study available Inhalation: no study available ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eac1264b-bbe4-46cf-8f8a-df4bede5c9db/documents/55430640-8157-42d4-a9de-cd4958d806b8_eb457783-982e-46a8-b61d-80170932a283.html,,,,,, "2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)ethane-1-sulfonyl chloride",4403-36-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eac1264b-bbe4-46cf-8f8a-df4bede5c9db/documents/55430640-8157-42d4-a9de-cd4958d806b8_eb457783-982e-46a8-b61d-80170932a283.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-(1,3-dioxoisoindolin-2-yl)ethane-1-sulfonamide",4443-23-6," Oral: LD50(rat, f) > 2000 mg/kg bw (OECD 423, GLP) Dermal: no study available Inhalation: no study available ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e5bfd4e-0f76-41ef-8a1e-08242481ed91/documents/c966a2fa-94c6-4274-96f7-1afdf9e85d1d_266e06f9-6907-4535-9bf0-691d1e885b52.html,,,,,, "2-(1,3-dioxoisoindolin-2-yl)ethane-1-sulfonamide",4443-23-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e5bfd4e-0f76-41ef-8a1e-08242481ed91/documents/c966a2fa-94c6-4274-96f7-1afdf9e85d1d_266e06f9-6907-4535-9bf0-691d1e885b52.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Acetic acid 2-oxo-2H-pyridin-1-yl ester,1742-79-6,"A combined repeated dose toxicity study with reproduction/developmental toxicity screening test (according to OECD TG 422, GLP) conducted in rats available for test substance. The LOAEL was 100 mg/kg/day based on effects associated with irritancy, including microscopic changes of necrosis, erosion, degeneration, and ulceration of the stomach. The NOAEL was 30 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/571eb201-c1d2-4923-939f-d93f0405f140/documents/ab026af7-5325-494b-a6c4-64e5e2f4b4c3_e9ddf04f-a822-4710-9e71-eeb27da9d753.html,,,,,, Acetic acid 2-oxo-2H-pyridin-1-yl ester,1742-79-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/571eb201-c1d2-4923-939f-d93f0405f140/documents/ab026af7-5325-494b-a6c4-64e5e2f4b4c3_e9ddf04f-a822-4710-9e71-eeb27da9d753.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat Acetic acid 2-oxo-2H-pyridin-1-yl ester,1742-79-6,"An acute oral toxicity study and a dermal acute toxicity study conducted in rats are available for oxypyrion-acetate. In an acute oral toxicity study (OECD TG 423, GLP, rats) the LD50 for the test substance was between 300 and 500 mg/kg. Based on the result of the study test substance is classified as Category 4 for acute oral toxicity according to Regulation (EC) No 1272/2008 (CLP Regulation). The acute dermal LD50 was greater than 2000 mg/kg bw in an acute dermal toxicity study (OECD TG 402, GLP, rats). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/571eb201-c1d2-4923-939f-d93f0405f140/documents/9eac4ad9-ab05-4047-9b17-e775bf787b37_e9ddf04f-a822-4710-9e71-eeb27da9d753.html,,,,,, Acetic acid 2-oxo-2H-pyridin-1-yl ester,1742-79-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/571eb201-c1d2-4923-939f-d93f0405f140/documents/9eac4ad9-ab05-4047-9b17-e775bf787b37_e9ddf04f-a822-4710-9e71-eeb27da9d753.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, Acetic acid 2-oxo-2H-pyridin-1-yl ester,1742-79-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/571eb201-c1d2-4923-939f-d93f0405f140/documents/9eac4ad9-ab05-4047-9b17-e775bf787b37_e9ddf04f-a822-4710-9e71-eeb27da9d753.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-(1-methylethoxy)ethyl acetate,19234-20-9,"Based on read-across from 2-isopropoxyethanol (CAS No. 109-59-1) and after correction for differences in molecular weight and stoichiometry of full enzymatic hydrolysis):NOAEL oral, systemic = 8 mg/kg bw/dNOAEC inhalation, systemic = 106 mg/m³ ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/165cd1d0-14e9-4527-adab-b1c672a52c6e/documents/IUC5-55286c1d-7e16-4133-b10d-1c918082e857_27c958c6-1224-44b4-96a2-78832791984d.html,,,,,, 2-(1-methylethoxy)ethyl acetate,19234-20-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/165cd1d0-14e9-4527-adab-b1c672a52c6e/documents/IUC5-55286c1d-7e16-4133-b10d-1c918082e857_27c958c6-1224-44b4-96a2-78832791984d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,8 mg/kg bw/day,,rat 2-(1-methylethoxy)ethyl acetate,19234-20-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/165cd1d0-14e9-4527-adab-b1c672a52c6e/documents/IUC5-55286c1d-7e16-4133-b10d-1c918082e857_27c958c6-1224-44b4-96a2-78832791984d.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,106 mg/m3,,rat 2-(1-methylethoxy)ethyl acetate,19234-20-9,"Oral: LD50 (rat, m/f) = >300 mg/kg bw <2000 mg/kg bwInhalation: LC50 (rat, m/f) > 12.3 mg/L Dermal: LD50 (rat, m/f) = >2000 mg/kg bw/d ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/165cd1d0-14e9-4527-adab-b1c672a52c6e/documents/IUC5-57ec2a50-2c86-4523-a8c1-aee6457ac8bb_27c958c6-1224-44b4-96a2-78832791984d.html,,,,,, 2-(1-methylethoxy)ethyl acetate,19234-20-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/165cd1d0-14e9-4527-adab-b1c672a52c6e/documents/IUC5-57ec2a50-2c86-4523-a8c1-aee6457ac8bb_27c958c6-1224-44b4-96a2-78832791984d.html,,oral,LD50,300 mg/kg bw,adverse effect observed, 2-(1-oxa-4-azaspiro[4.5]dec-4-yl)ethyl methacrylate,4203-89-8,"An OECD 422 oral gavage study was done in male/female Wistar rats at 0, 50, 150 and 375 mg/kg bw/d. Based on systemic effects (body weight, food conversion efficiency) and organ weight increase (liver and kidney) some kidney histopathology results, the NOAEL was considered to be 50 mg/kg bw/d for males and females. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Good (GLP study) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c742580c-e456-4247-9c9c-8ba9f6510f66/documents/251d162f-7aeb-41ab-a51c-6e9324b06c7d_56aae315-89be-4b0d-82de-342315220e29.html,,,,,, 2-(1-oxa-4-azaspiro[4.5]dec-4-yl)ethyl methacrylate,4203-89-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c742580c-e456-4247-9c9c-8ba9f6510f66/documents/251d162f-7aeb-41ab-a51c-6e9324b06c7d_56aae315-89be-4b0d-82de-342315220e29.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 2-(1-oxa-4-azaspiro[4.5]dec-4-yl)ethyl methacrylate,4203-89-8, Oral LD50 is 3500 mg/L. Dermal and inhalation endpoints were waived as the substance is corrosive. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c742580c-e456-4247-9c9c-8ba9f6510f66/documents/7fb6e409-a604-4f68-92f3-969fd60e4353_56aae315-89be-4b0d-82de-342315220e29.html,,,,,, 2-(1-oxa-4-azaspiro[4.5]dec-4-yl)ethyl methacrylate,4203-89-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c742580c-e456-4247-9c9c-8ba9f6510f66/documents/7fb6e409-a604-4f68-92f3-969fd60e4353_56aae315-89be-4b0d-82de-342315220e29.html,,oral,LD50,"3,500 mg/kg bw",adverse effect observed, 2-(2-(2-butoxyethoxy)ethoxy)ethanol,143-22-6,       ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69b2c5c2-a43e-475e-a589-3b4146b0f495/documents/IUC5-3405b56f-9417-486f-ab79-a68fd15e7343_2b5d64b4-37d5-4fbb-aeee-76a4b1fe48d9.html,,,,,, 2-(2-(2-butoxyethoxy)ethoxy)ethanol,143-22-6,"Oral LD50 data in rats: 6650, 5170 mg/kgDermal LD50 in rabbits: 3540 mg/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69b2c5c2-a43e-475e-a589-3b4146b0f495/documents/IUC5-5c9bcb0c-e7d5-4fc6-a6c6-b41448ca612a_2b5d64b4-37d5-4fbb-aeee-76a4b1fe48d9.html,,,,,, 2-(2-(2-butoxyethoxy)ethoxy)ethanol,143-22-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69b2c5c2-a43e-475e-a589-3b4146b0f495/documents/IUC5-5c9bcb0c-e7d5-4fc6-a6c6-b41448ca612a_2b5d64b4-37d5-4fbb-aeee-76a4b1fe48d9.html,,oral,LD50,"5,170 mg/kg bw",, 2-(2-(2-butoxyethoxy)ethoxy)ethanol,143-22-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69b2c5c2-a43e-475e-a589-3b4146b0f495/documents/IUC5-5c9bcb0c-e7d5-4fc6-a6c6-b41448ca612a_2b5d64b4-37d5-4fbb-aeee-76a4b1fe48d9.html,,dermal,LD50,"3,540 mg/kg bw",, 2-(2-(2-ethoxyethoxy)ethoxy)ethanol,112-50-5, ORAL - RATS (mg/kg): 10600 DERMAL LD50 (mg/kg) TEGME read across substance: Rabbit: 7.45mg/kg TEGBE read across substance: Rabbit: 3.45ml/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12979cff-835d-423a-93e1-6a80b0a29e69/documents/IUC5-b779759f-3b5b-41c9-a449-e2b882ae3789_89816ecc-58a4-4238-96a7-37ca5bab6a72.html,,,,,, 2-(2-(2-ethoxyethoxy)ethoxy)ethanol,112-50-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12979cff-835d-423a-93e1-6a80b0a29e69/documents/IUC5-b779759f-3b5b-41c9-a449-e2b882ae3789_89816ecc-58a4-4238-96a7-37ca5bab6a72.html,,oral,LD50,"10,610 mg/kg bw",adverse effect observed, 2-(2-(2-methoxyethoxy)ethoxy)ethanol,112-35-6,"ALL DATA IN RATS, NOAELs in mg/kgbw/day Oral, 90 day: key study - no adverse effects seen at 1000. Dermal, 21 days: 1000 - no effects seen at maximum tested dose Dermal, 90 days: 4000 - no effects seen at maximum tested dose Inhalation: Due to the very low vapour pressure of this substance, based on the low toxicity by the oral route it can be concluded there is no hazard from inhalation of vapours. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd85a25b-f6a9-463e-b8a4-2c583233427a/documents/IUC5-9abae761-b3e9-4d3e-8125-0e88d4f089da_5b09315e-91e0-4cbc-bf27-b36a39b9ce05.html,,,,,, 2-(2-(2-methoxyethoxy)ethoxy)ethanol,112-35-6,"ORAL - RATS (mg/kg)TEGME: LD50: >10500, 11.3ml/kgDERMAL LD50 (mg/kg)TEGME: Rat: Rabbit: 7.45mL/kgMix of tri, tetra, and penta methyls: Rat LD0: >2000mg/kg, >4mL/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd85a25b-f6a9-463e-b8a4-2c583233427a/documents/IUC5-948b9fdc-6722-43a5-a484-4874fbd7f55a_5b09315e-91e0-4cbc-bf27-b36a39b9ce05.html,,,,,, 2-(2-(2-methoxyethoxy)ethoxy)ethanol,112-35-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd85a25b-f6a9-463e-b8a4-2c583233427a/documents/IUC5-948b9fdc-6722-43a5-a484-4874fbd7f55a_5b09315e-91e0-4cbc-bf27-b36a39b9ce05.html,,oral,LD50,"10,500 mg/kg bw",, "2,8,14-trimethyl-5,11-dioxa-2,8,14-triazapentadecane",65286-55-7,"Repeated dose toxicity - oral: A key, K1 study in male and female Wistar rats in a combined repeated dose toxicity test with reproductive/developmental screening was conducted according to OECD guideline 422 (Edwards, 2018). Based upon the study data, the NOAEL is considered to be 100 mg/kg bw/day since no adverse effects have been identified at or below this dose level. A 90-day oral repeated dose study in rats (key, K1; Rees, 2023) performed according to OECD 408 guideline and to GLP requirements. A NOAEL value for systemic toxicity of 25 mg/kg/day was derived. Repeated dose toxicity - dermal or inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, Annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation or dermal route of exposure. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch 1 scoring, according to OECD guideline, GLP-compliant ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8efae12c-7f42-43d2-acb7-d438e6bb3807/documents/1f1925cd-ce63-4673-bb76-b2d8ab619c74_69b45844-4c8e-4196-b260-06401adb738f.html,,,,,, "2,8,14-trimethyl-5,11-dioxa-2,8,14-triazapentadecane",65286-55-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8efae12c-7f42-43d2-acb7-d438e6bb3807/documents/1f1925cd-ce63-4673-bb76-b2d8ab619c74_69b45844-4c8e-4196-b260-06401adb738f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat "2,8,14-trimethyl-5,11-dioxa-2,8,14-triazapentadecane",65286-55-7,"No acute toxicity studies via the oral, inhalation or dermal route are available for this substance. As the substance is classified as corrosive to the skin, studies for the acute toxicity endpoint are waived (column 2, Annex VIII, REACH Regulation). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8efae12c-7f42-43d2-acb7-d438e6bb3807/documents/2ebae577-a43f-4e53-9ba7-601d128a1a63_69b45844-4c8e-4196-b260-06401adb738f.html,,,,,, "2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolane-4-methanol",84682-23-5," Repeated dose toxicity - oral: In a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the test substance was administered daily to rats up to a dose level of 500 mg/kg body weight/day (OECD 422; Van Otterdijk, 2016). The NOAEL is established as 50 mg/kg body weight/day. The substance is therefore classified as STOT RE 2, according to CLP Regulation. Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f5a0c7a-0338-4c0d-83bc-67ab559c61b9/documents/21bbb1c6-14f2-4d53-a2b5-be2cbe92d21c_bc6ce4cf-9b33-4ffd-8c24-3d8d0b21fc84.html,,,,,, "2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolane-4-methanol",84682-23-5,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f5a0c7a-0338-4c0d-83bc-67ab559c61b9/documents/21bbb1c6-14f2-4d53-a2b5-be2cbe92d21c_bc6ce4cf-9b33-4ffd-8c24-3d8d0b21fc84.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolane-4-methanol",84682-23-5," Acute toxicity: Oral In an acute oral toxicity study in female Crl:WI (Han) (SPF) rats, following the acute toxic class method in accordance with the OECD Guideline 423 and EU Method B.1 tris, the LD50 was established to exceed 2000 mg/kg. According to the OECD 423 guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. Acute toxicity: Inhalation No reliable acute toxicity study via the inhalation route was available. However, this endpoint is waived as specific data are available for the oral and dermal exposure routes. Acute toxicity: Dermal In an acute dermal toxicity study in male and female Crl:WI (Han) (SPF) rats, following the standard acute method according to OECD Guideline 402 and EC method B.3, the LD50 was established to exceed 2000 mg/kg body weight. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f5a0c7a-0338-4c0d-83bc-67ab559c61b9/documents/026ebce7-01f9-4c8a-b4d7-416b8616a528_bc6ce4cf-9b33-4ffd-8c24-3d8d0b21fc84.html,,,,,, "2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolane-4-methanol",84682-23-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f5a0c7a-0338-4c0d-83bc-67ab559c61b9/documents/026ebce7-01f9-4c8a-b4d7-416b8616a528_bc6ce4cf-9b33-4ffd-8c24-3d8d0b21fc84.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolane-4-methanol",84682-23-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f5a0c7a-0338-4c0d-83bc-67ab559c61b9/documents/026ebce7-01f9-4c8a-b4d7-416b8616a528_bc6ce4cf-9b33-4ffd-8c24-3d8d0b21fc84.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-(2-butoxyethoxy)ethyl methacrylate,7328-22-5,"Subacute study; oral (gavage); rat (Hsd: Sprague Dawley SD), m/f (OECD guideline 422, Klimisch score: 1,GLP), with Butyldiglycol methacrylate: NOAEL = 1000 mg/kg bw/d (HRTF, 2014). The primary metabolite of BDGMA, the alcohol Butyldiglycol, did not show any effects of systemic toxicity towards male and female rats at doses up to 2000 mg/kg/day when administered dermally over a 13 week period. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Study well documented and in accordance to scientifically accepted principles, minor deviations to OECD guideline Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Relaible witout restriction (Klimisch score: 1) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/123bd92e-809a-4d6a-8dca-91a86bfdc8bd/documents/IUC5-ac52fbed-795f-4489-9baf-2edd407a2e27_3aeba3c9-e960-4f7f-997f-33f12fd78ee4.html,,,,,, 2-(2-butoxyethoxy)ethyl methacrylate,7328-22-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/123bd92e-809a-4d6a-8dca-91a86bfdc8bd/documents/IUC5-ac52fbed-795f-4489-9baf-2edd407a2e27_3aeba3c9-e960-4f7f-997f-33f12fd78ee4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-(2-butoxyethoxy)ethyl methacrylate,7328-22-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/123bd92e-809a-4d6a-8dca-91a86bfdc8bd/documents/IUC5-ac52fbed-795f-4489-9baf-2edd407a2e27_3aeba3c9-e960-4f7f-997f-33f12fd78ee4.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rat 2-(2-butoxyethoxy)ethyl methacrylate,7328-22-5,"Acute oral toxicity: LD50 (rat, combined) >= 2000 mg/kg bw; OECD Guideline 401 Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): One relevant, reliable (Klimisch score = 1) and adequate study is available. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/123bd92e-809a-4d6a-8dca-91a86bfdc8bd/documents/IUC5-8abb4f8e-c984-4e63-bc83-777f4e9394af_3aeba3c9-e960-4f7f-997f-33f12fd78ee4.html,,,,,, 2-(2-butoxyethoxy)ethyl methacrylate,7328-22-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/123bd92e-809a-4d6a-8dca-91a86bfdc8bd/documents/IUC5-8abb4f8e-c984-4e63-bc83-777f4e9394af_3aeba3c9-e960-4f7f-997f-33f12fd78ee4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-(2-ethoxyethoxy)-2-methylpropane,51422-54-9,"Under the conditions of an OECD 422 combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in Wistar rats the following NOAEC were determined for 2-(2-ethoxyethoxy)-2-methylpropane after inhalation exposure: The NOAEC for local toxicity at the respiratory tract was 750 mg/m³ for the F0 females and males because no adverse findings were observed at the respiratory tract up to the tested high concentration. The NOAEC for general, systemic toxicity was 250 mg/m³ for the F0 females and males based on the normochromic normocytic anemia and the associated extramedullary hematopoiesis in the spleen. [BASF, 2015] ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/184386b1-7f1f-4255-96d9-1b84525c775c/documents/IUC5-17071792-b405-402d-8e04-2e0ae784f6bc_e191c158-05e1-4bb4-9634-8e0fd0d4dae3.html,,,,,, 2-(2-ethoxyethoxy)-2-methylpropane,51422-54-9,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/184386b1-7f1f-4255-96d9-1b84525c775c/documents/IUC5-17071792-b405-402d-8e04-2e0ae784f6bc_e191c158-05e1-4bb4-9634-8e0fd0d4dae3.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,250 mg/m3,,rat 2-(2-ethoxyethoxy)-2-methylpropane,51422-54-9,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/184386b1-7f1f-4255-96d9-1b84525c775c/documents/IUC5-17071792-b405-402d-8e04-2e0ae784f6bc_e191c158-05e1-4bb4-9634-8e0fd0d4dae3.html,Repeated dose toxicity – local effects,inhalation,NOAEC,750 mg/m3,no adverse effect observed,rat 2-(2-ethoxyethoxy)-2-methylpropane,51422-54-9,"Oral: In an acute oral toxicity study to rats the effect of the test item was determined according to OECD guideline 401. The LD50 was determined to be 3600 mg/kg bw. Inhalation: The acute inhalation toxicity effect of the test item was determined in a study according to OECD guideline 403, EU method B2 and OPPTS 870.1300. The LC50 was determined to be 10.5 mg/L air. Dermal: In an acute dermal toxicity study to Wistar rats the effect of the test item was determined according to OECD guideline 402, EU method B3 and OPPTS 870.1200. The LD50 was determined to be >2000 mg/kg bw. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/184386b1-7f1f-4255-96d9-1b84525c775c/documents/IUC5-1b947796-4ad5-45e5-ba43-865039037ec6_e191c158-05e1-4bb4-9634-8e0fd0d4dae3.html,,,,,, 2-(2-ethoxyethoxy)-2-methylpropane,51422-54-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/184386b1-7f1f-4255-96d9-1b84525c775c/documents/IUC5-1b947796-4ad5-45e5-ba43-865039037ec6_e191c158-05e1-4bb4-9634-8e0fd0d4dae3.html,,oral,LD50,"3,600 mg/kg bw",adverse effect observed, 2-(2-ethoxyethoxy)-2-methylpropane,51422-54-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/184386b1-7f1f-4255-96d9-1b84525c775c/documents/IUC5-1b947796-4ad5-45e5-ba43-865039037ec6_e191c158-05e1-4bb4-9634-8e0fd0d4dae3.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-(2-ethoxyethoxy)-2-methylpropane,51422-54-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/184386b1-7f1f-4255-96d9-1b84525c775c/documents/IUC5-1b947796-4ad5-45e5-ba43-865039037ec6_e191c158-05e1-4bb4-9634-8e0fd0d4dae3.html,,inhalation,LC50,"10,500 mg/m3",adverse effect observed, "2-(2H-benzotriazol-2-yl)-4,6-bis(1-methyl-1-phenylethyl)phenol",70321-86-7," Treatment of rats in a 13 weeks feeding study identified a LOAEL of 2,000 ppm (corresponding to 152.7 and 155.1 mg/kg bw/day in males and females respectively). A NOAEL of 300 ppm (nominal) was identified which corresponds to a mean daily intake of ca. 22.5 mg/kg bw  and 22.1 mg/kg bw  for males and females, respectively. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9d987b7-4051-4d09-b609-3b7ca82b916d/documents/IUC5-1f52864e-d7dd-4b6b-a908-61cbd1341e54_d185ce9f-7c08-4872-b104-589d68339d13.html,,,,,, "2-(2H-benzotriazol-2-yl)-4,6-bis(1-methyl-1-phenylethyl)phenol",70321-86-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9d987b7-4051-4d09-b609-3b7ca82b916d/documents/IUC5-1f52864e-d7dd-4b6b-a908-61cbd1341e54_d185ce9f-7c08-4872-b104-589d68339d13.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,22.3 mg/kg bw/day,,rat "2-(2H-benzotriazol-2-yl)-4,6-bis(1-methyl-1-phenylethyl)phenol",70321-86-7," - LD50 acute oral toxicity (male and female; rat): > 7,750 mg/kg bw (BASF, 784965, 1978; reliability score: 2) - LD50 acute dermal toxicity (male and female; rat): > 2000 mg/kg bw (BASF, 934003, 1993; reliability score: 1 (OECD 402)) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9d987b7-4051-4d09-b609-3b7ca82b916d/documents/IUC5-cba9b90d-45e1-46d9-8da6-4d661e5dbb2c_d185ce9f-7c08-4872-b104-589d68339d13.html,,,,,, "2-(2H-benzotriazol-2-yl)-4,6-bis(1-methyl-1-phenylethyl)phenol",70321-86-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9d987b7-4051-4d09-b609-3b7ca82b916d/documents/IUC5-cba9b90d-45e1-46d9-8da6-4d661e5dbb2c_d185ce9f-7c08-4872-b104-589d68339d13.html,,oral,discriminating dose,"7,750 mg/kg bw",no adverse effect observed, "2-(2H-benzotriazol-2-yl)-4,6-bis(1-methyl-1-phenylethyl)phenol",70321-86-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9d987b7-4051-4d09-b609-3b7ca82b916d/documents/IUC5-cba9b90d-45e1-46d9-8da6-4d661e5dbb2c_d185ce9f-7c08-4872-b104-589d68339d13.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol",25973-55-1,"In the Inbifo study (No. A 0176/049, 1970) the oral repeated dose toxicity (90 days, subchronic) in the dog was determined similar to the OECD guideline 409 and a NOAEL was set at 30 mg/kg body weight in the dog. In the TNO study (No. R 2640, 1968) the oral repeated dose toxicity (90 days, subchronic) in the rat was determined similar to the OECD guideline 408 and a LOAEL was at 10 mg/kg body weight in the rat (lowest concentration tested). The NOAEL is assumed to be < 10 mg/kg bw. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2ecb390-b567-4c74-b600-4a71669dcce9/documents/IUC5-19ebccb7-a811-4f1c-80ce-690979128a73_d10b0703-28b2-427f-bcf4-2f4f9ee744f9.html,,,,,, "2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol",25973-55-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2ecb390-b567-4c74-b600-4a71669dcce9/documents/IUC5-19ebccb7-a811-4f1c-80ce-690979128a73_d10b0703-28b2-427f-bcf4-2f4f9ee744f9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,dog "2-(2H-benzotriazol-2-yl)-4,6-ditertpentylphenol",25973-55-1,"In the CIBA-Geigy (Siss 6481, 1978) acute oral toxicity study, conducted similar to the OECD-Guideline 401, the oral LD50 was determined to be > 7750 mg/kg body weight (no mortality). In the CIBA-Geigy (Siss 3502, 1973) acute inhalation toxicity study, conducted similar to the OECD-Guideline 403, the inhalative LC50 was determined to be > 0.4 mg/l (no mortality). In the Geigy (U. K.) Ltd. (8/69/S. L., 1969) acute dermal toxicity study, conducted similar to the OECD-Guideline 402, the dermal LD50 was determined to be > 1100 mg/kg body weight (no mortality). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2ecb390-b567-4c74-b600-4a71669dcce9/documents/IUC5-e8a0d128-ebcc-40a2-9812-3e3332566383_d10b0703-28b2-427f-bcf4-2f4f9ee744f9.html,,,,,, "2-(2H-Benzotriazol-2-yl)-6-(1-methyl-1-phenylethyl)-4-(1,1,3,3-tetramethylbutyl)phenol",73936-91-1,"Repeated administration of the test item up to 90 consecutive days to rats did not reveal any adverse effects to the test species. Therefore, a NOAEL of 1000 mg/kg/day has been established. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1c9e43a-7d9f-451b-9467-96dfb284fbdb/documents/IUC5-88df3464-838f-43f1-83e3-a3c993a7caa7_1c2f2185-1fca-4454-a8cd-501673f47ea6.html,,,,,, "2-(2H-Benzotriazol-2-yl)-6-(1-methyl-1-phenylethyl)-4-(1,1,3,3-tetramethylbutyl)phenol",73936-91-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1c9e43a-7d9f-451b-9467-96dfb284fbdb/documents/IUC5-88df3464-838f-43f1-83e3-a3c993a7caa7_1c2f2185-1fca-4454-a8cd-501673f47ea6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-(2H-Benzotriazol-2-yl)-6-(1-methyl-1-phenylethyl)-4-(1,1,3,3-tetramethylbutyl)phenol",73936-91-1,The test item did not induce acute toxicity after oral and dermal application at 2000 mg/kg. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1c9e43a-7d9f-451b-9467-96dfb284fbdb/documents/IUC5-31ed04cd-b771-4f1c-b1b3-a61b466aa055_1c2f2185-1fca-4454-a8cd-501673f47ea6.html,,,,,, "2-(2H-Benzotriazol-2-yl)-6-(1-methyl-1-phenylethyl)-4-(1,1,3,3-tetramethylbutyl)phenol",73936-91-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1c9e43a-7d9f-451b-9467-96dfb284fbdb/documents/IUC5-31ed04cd-b771-4f1c-b1b3-a61b466aa055_1c2f2185-1fca-4454-a8cd-501673f47ea6.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-(2H-Benzotriazol-2-yl)-6-(1-methyl-1-phenylethyl)-4-(1,1,3,3-tetramethylbutyl)phenol",73936-91-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1c9e43a-7d9f-451b-9467-96dfb284fbdb/documents/IUC5-31ed04cd-b771-4f1c-b1b3-a61b466aa055_1c2f2185-1fca-4454-a8cd-501673f47ea6.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-(2-heptadec-8-enyl-2-imidazolin-1-yl)ethanol,95-38-5," The NOAEL for general, systemic toxicity of the test substance was 20 mg/kg bw/d for male and female based on clinical and pathological findings. At ≥ 60 mg/kg bw/day, local specific effects were observed in the thymus and jejunum. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/15e5e923-10e7-414a-bdd6-df4f8cfb3002/documents/IUC5-124fc5c4-740f-46c5-ab1a-cba672b9abd5_35739109-f67c-4962-8100-711c3d8846df.html,,,,,, 2-(2-heptadec-8-enyl-2-imidazolin-1-yl)ethanol,95-38-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/15e5e923-10e7-414a-bdd6-df4f8cfb3002/documents/IUC5-124fc5c4-740f-46c5-ab1a-cba672b9abd5_35739109-f67c-4962-8100-711c3d8846df.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat 2-(2-heptadec-8-enyl-2-imidazolin-1-yl)ethanol,95-38-5,LD50 oral (rat): 1000 mg/kg bw (males) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15e5e923-10e7-414a-bdd6-df4f8cfb3002/documents/IUC5-19ba754e-20b1-455f-89ff-7e7d3afbb455_35739109-f67c-4962-8100-711c3d8846df.html,,,,,, 2-(2-heptadec-8-enyl-2-imidazolin-1-yl)ethanol,95-38-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15e5e923-10e7-414a-bdd6-df4f8cfb3002/documents/IUC5-19ba754e-20b1-455f-89ff-7e7d3afbb455_35739109-f67c-4962-8100-711c3d8846df.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, 2-(2-hexyldecyloxy)benzamide,202483-62-3,"Oral: NOAEL (rat, 28d, OECD 407) ≥ 1000 mg/kg bw/d ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d52e95ab-5a61-4ccc-acbe-417a1ab7157f/documents/IUC5-47197b18-da70-44ef-9f1e-c1c9f4108653_6cb3445b-b43f-4195-bb16-3f9fbd6ada6a.html,,,,,, 2-(2-hexyldecyloxy)benzamide,202483-62-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d52e95ab-5a61-4ccc-acbe-417a1ab7157f/documents/IUC5-47197b18-da70-44ef-9f1e-c1c9f4108653_6cb3445b-b43f-4195-bb16-3f9fbd6ada6a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-(2-hexyldecyloxy)benzamide,202483-62-3,"Oral (OECD 423), rat: LD50 = 5000 mg/kg bw (cut-off value, limit test)Dermal (OECD 403), rat: LD50 ≥ 2000 mg/kg bw (limit test) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d52e95ab-5a61-4ccc-acbe-417a1ab7157f/documents/IUC5-fba81281-11bb-4a17-877d-f6ab28e26a9e_6cb3445b-b43f-4195-bb16-3f9fbd6ada6a.html,,,,,, 2-(2-hexyldecyloxy)benzamide,202483-62-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d52e95ab-5a61-4ccc-acbe-417a1ab7157f/documents/IUC5-fba81281-11bb-4a17-877d-f6ab28e26a9e_6cb3445b-b43f-4195-bb16-3f9fbd6ada6a.html,,oral,LD50,"5,000 mg/kg bw",, 2-(2-hexyldecyloxy)benzamide,202483-62-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d52e95ab-5a61-4ccc-acbe-417a1ab7157f/documents/IUC5-fba81281-11bb-4a17-877d-f6ab28e26a9e_6cb3445b-b43f-4195-bb16-3f9fbd6ada6a.html,,dermal,LD50,"2,000 mg/kg bw",, 2-(2-hexyloxyethoxy)ethanol,112-59-4,"oral studies   OECD 422, diet: NOAEL = 300mg/kg (based on liver and body weight effects), Dow 2004   6 weeks, gavage: LOAEL 891mg/kg (based on reduced body weight), Eastman Kodak, 1982, RA substance DEGBE   OECD 408, drinking water, 90 -days: NOAEL = 250mg/kg (based on liver and body weight effects), Johnson et al. 2005, RA substance DEGBE    dermal studies   90 days, dermal: NOAEL = 2000mg/kg (highest dose tested), LOAEL for local effects = 200mg/kg, Auletta et al. 1993, RA substance DEGBE    inhalation studies   5 weeks, vapour: NOAEC = 18ppm, app. 0.12mg/L (highest dose tested), Dow 1981, RA substance DEGBE   OECD 413, vapour, 90 days: NOAEC = 14ppm, app. 0.09 mg/L (highest dose tested), BASF 1992, RA substance DEGBE   OECD 413, vapour, 90 days: NOAEC = 41ppm, app. 0.25mg/L (based on liver and body weight effects), Dow, 1985, RA substance EGHE   Corrected for differences in molecular weight (146 vs. 190 g/mol) between EGHE and DEGHE results in a NOAEC for DEGHE of 0.33 mg/L. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/334c7ef1-8d50-4a93-8bb9-133f5aaa0108/documents/IUC5-1b9f9457-aff7-4b20-9856-c1ff29c5fb4a_d438796c-26aa-491d-bfa9-25d4018da915.html,,,,,, 2-(2-hexyloxyethoxy)ethanol,112-59-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/334c7ef1-8d50-4a93-8bb9-133f5aaa0108/documents/IUC5-1b9f9457-aff7-4b20-9856-c1ff29c5fb4a_d438796c-26aa-491d-bfa9-25d4018da915.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 2-(2-hexyloxyethoxy)ethanol,112-59-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/334c7ef1-8d50-4a93-8bb9-133f5aaa0108/documents/IUC5-1b9f9457-aff7-4b20-9856-c1ff29c5fb4a_d438796c-26aa-491d-bfa9-25d4018da915.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rat 2-(2-hexyloxyethoxy)ethanol,112-59-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/334c7ef1-8d50-4a93-8bb9-133f5aaa0108/documents/IUC5-1b9f9457-aff7-4b20-9856-c1ff29c5fb4a_d438796c-26aa-491d-bfa9-25d4018da915.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,325 mg/m3,,rat 2-(2-hexyloxyethoxy)ethanol,112-59-4,"An acute oral toxicity test was performed in male and female rats leading to an oral LD50 of 4600 mg/kg bw for males and 3488 mg/kg bw for females (Ballantyne, 1987).   A dermal LD50 of 2001 mg/kg bw for male rabbits and 2216 mg/kg bw for female rabbits was found in an acute dermal toxicity test (Ballantyne, 1987).   An acute inhalation toxicity tests with saturated vapour atmosphere did not lead to any mortality in male and female rats (Ballantyne, 1987). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/334c7ef1-8d50-4a93-8bb9-133f5aaa0108/documents/IUC5-5b85c968-6069-42aa-a0bb-d252081fcaf1_d438796c-26aa-491d-bfa9-25d4018da915.html,,,,,, 2-(2-hexyloxyethoxy)ethanol,112-59-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/334c7ef1-8d50-4a93-8bb9-133f5aaa0108/documents/IUC5-5b85c968-6069-42aa-a0bb-d252081fcaf1_d438796c-26aa-491d-bfa9-25d4018da915.html,,oral,LD50,"3,488 mg/kg bw",adverse effect observed, 2-(2-hexyloxyethoxy)ethanol,112-59-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/334c7ef1-8d50-4a93-8bb9-133f5aaa0108/documents/IUC5-5b85c968-6069-42aa-a0bb-d252081fcaf1_d438796c-26aa-491d-bfa9-25d4018da915.html,,dermal,LD50,"2,001 mg/kg bw",adverse effect observed, 2-(2-methylpropoxy)ethanol,4439-24-1," A combined repeated dose toxicity study with Reproduction/Developmental Toxicity Screening test for 2 -(2 -methylpropxy)ethanol via the oral route was carried out on rats in compliance with GLP and in accordance with the Japanese Guideline ""Methods of Testing for new Chemical Substances (2011). Doses of 0, 15, 50 and 150 mg/kg were administered to 12 male and 12 females rats respectively (24 rats in total per dose).The male rats were dissected after 42-days consecutive administration. Test substance was administrated to female rat for 42~47 consecutive days (from two weeks before mating to 4th day of suckle). New-born infant was dissected on the 4th day of suckle while female who delivered a new-born infant was dissected on the 5th. With regard to 0 and 150mg/kg administration, a non-mated females (10/group) were prepared. Half of them are dissected after 42-days consecutive administration while the remaining half and 5 males with dose of 0 and 150 mg/kg were dissected after they had been raised for 14 days. Administration of test substance did not influence estrus cycle, copulation and pregnancy rate in provided experiment conditions. Pregnancy period, birthrate, delivering rate and suckling state were not influenced by administration of test substance. Administration of test substance did not affect the number of corpus luteum and implantation or implantation rate. Therefore, test substance was considered not to have reproductive toxicity to parental animals in conditions less than 150 mg/kg dose. Hematologic tests on completion of administration showed a decline of erythrocyte number was observed in both male groups more than 50 mg/kg/day and female groups at 150 mg/kg day. It also revealed decline of haemoglobin concentration in the >50 mg/kg male groups and 150 mg/kg non-mated female group.With regard to bone marrow of thighbone, hyperplasia of erythroblast was observed male group and the female groups which gave birth in conditions more than 15 mg/kg dose, as well as non-mated female group exposed to the 150 mg/kg dose. Increased spleen weightsspleen in 50 mg/kg females who gave birth and 150 mg/kg non-mated females was considered to be caused by the test substance. The NOEAL was concluded to be 150 mg/kg/day for reproductive and developmental toxicity and <15 mg/kg/day for repeated dose toxicity based on the effects obseved on the blood. A classification of classification as STOT RE 2; H373: May cause damage to organs (blood) through prolonged or repeated exposure (oral route) is recommended in accordance with with Regulation (EC) N° 1272/2008. The NOEAL was concluded to be 150 mg/kg/day for reproductive and developmental toxicity and <15 mg/kg/day for repeated dose toxicity. A classification of classification as STOT RE 2; H373: May cause damage to organs (blood) through prolonged or repeated exposure (oral route) is recommended in accordance with with Regulation (EC) N° 1272/2008 based on the significant effects on the blood observed at doses >50 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b58ef63-776a-4077-b1e0-a24786956c64/documents/5701f45d-11e8-4d0d-92ad-6b139ac8b563_99c9b6b7-ac0c-4b88-a508-332b59696825.html,,,,,, 2-(2-methylpropoxy)ethanol,4439-24-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b58ef63-776a-4077-b1e0-a24786956c64/documents/5701f45d-11e8-4d0d-92ad-6b139ac8b563_99c9b6b7-ac0c-4b88-a508-332b59696825.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat 2-(2-methylpropoxy)ethanol,4439-24-1," An acute toxicity study via the oral route was not carried out as the substance is classified as corrosive. However, oral LD50 values for rat ranging from 400 mg/kg bw to 1000 mg/kg bw were reported in a handbook. Based on these values the subtance should be classified as acute toxicity Category 4 in accordance with Regulation (EC) No 1272/2008. There was no available data on the acute toxicity of the substance via the inhalation route. For acute toxicity via the dermal route, values of dermal LD50 of 200 -400 mg/kg bw for rabbit was reported in a toxicology handbook. Based on the reported values the substance meets the criteria for Acute toxicity Category 3 via the dermal route in accordance with CLP regulation. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b58ef63-776a-4077-b1e0-a24786956c64/documents/bcbf3c58-c3c1-42c4-a1b2-6d5c9b98f2b5_99c9b6b7-ac0c-4b88-a508-332b59696825.html,,,,,, 2-(2-methylpropoxy)ethanol,4439-24-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b58ef63-776a-4077-b1e0-a24786956c64/documents/bcbf3c58-c3c1-42c4-a1b2-6d5c9b98f2b5_99c9b6b7-ac0c-4b88-a508-332b59696825.html,,oral,LD50,400 mg/kg bw,adverse effect observed, 2-(2-methylpropoxy)ethanol,4439-24-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b58ef63-776a-4077-b1e0-a24786956c64/documents/bcbf3c58-c3c1-42c4-a1b2-6d5c9b98f2b5_99c9b6b7-ac0c-4b88-a508-332b59696825.html,,dermal,LD50,200 mg/kg bw,adverse effect observed, 2-(2-naphthyloxy)ethanol,93-20-9,28 day repeat dose oral study in rat: NOAEL 50 mg/kg/day.90 day repeat dose dermal study in rabbit: NOAEL 500 mg/kg/day (Read-across from 2-phenoxyethanol) ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b510fac-8a80-495f-b700-2fe4bbfd7939/documents/IUC5-d4a30148-b73f-4073-a46a-82f51ada4206_23b4c9cc-ce0d-4e65-a2e8-7928ae3a2510.html,,,,,, 2-(2-naphthyloxy)ethanol,93-20-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b510fac-8a80-495f-b700-2fe4bbfd7939/documents/IUC5-d4a30148-b73f-4073-a46a-82f51ada4206_23b4c9cc-ce0d-4e65-a2e8-7928ae3a2510.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 2-(2-naphthyloxy)ethanol,93-20-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b510fac-8a80-495f-b700-2fe4bbfd7939/documents/IUC5-d4a30148-b73f-4073-a46a-82f51ada4206_23b4c9cc-ce0d-4e65-a2e8-7928ae3a2510.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rabbit 2-(2-naphthyloxy)ethanol,93-20-9,Acute Oral (OECD 423): LD50 >2000 mg/kg.Acute Dermal Study (OECD 402): LD50 >2000 mg/kg. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b510fac-8a80-495f-b700-2fe4bbfd7939/documents/IUC5-80b02eaa-8fbc-4333-8c34-5e9fc17fa9a8_23b4c9cc-ce0d-4e65-a2e8-7928ae3a2510.html,,,,,, 2-(2-naphthyloxy)ethanol,93-20-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b510fac-8a80-495f-b700-2fe4bbfd7939/documents/IUC5-80b02eaa-8fbc-4333-8c34-5e9fc17fa9a8_23b4c9cc-ce0d-4e65-a2e8-7928ae3a2510.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, 2-(2-oxoimidazolidin-1-yl)ethyl methacrylate,86261-90-7,"Combined repeated dose study in rats (OECD TG 422), gavage: NOAEL parental toxicity: 100 mg/kg bw/day in males and 300 mg/kg bw/day in females (due to increased organ weights; GLP, Rohm & Haas 2002) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c970e27-cb61-44a4-9a49-5e4be186f09c/documents/IUC5-88830b6b-450d-4cf2-9367-b04e4e46be1f_f65b4e69-1de4-4e19-86bc-37dd184974ff.html,,,,,, 2-(2-oxoimidazolidin-1-yl)ethyl methacrylate,86261-90-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c970e27-cb61-44a4-9a49-5e4be186f09c/documents/IUC5-88830b6b-450d-4cf2-9367-b04e4e46be1f_f65b4e69-1de4-4e19-86bc-37dd184974ff.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 2-(2-oxoimidazolidin-1-yl)ethyl methacrylate,86261-90-7,"oralrat: LD50 > 5000 mg/kg bw; transient clinical signs (OECD 401; BASF AG 1986)rat: LD50 > 5000 mg/kg bw; reduced bw in females (GLP, OECD 401; Rohm & Haas 2002)rat: LD50 > 2000 mg/kg bw; no clinical signs (GLP, OECD 423; BSL 2000)inhalationno data availabledermalrat: LD50 > 5000 mg/kg bw (GLP, OECD 402; Rohm & Haas 2002) rabbit: LD > 5000 mg/kg bw (Rohm & Haas 1977, 1976) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c970e27-cb61-44a4-9a49-5e4be186f09c/documents/IUC5-c4edd6f4-fc08-41d9-af51-6d847135b656_f65b4e69-1de4-4e19-86bc-37dd184974ff.html,,,,,, 2-(2-oxoimidazolidin-1-yl)ethyl methacrylate,86261-90-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c970e27-cb61-44a4-9a49-5e4be186f09c/documents/IUC5-c4edd6f4-fc08-41d9-af51-6d847135b656_f65b4e69-1de4-4e19-86bc-37dd184974ff.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-(2-oxoimidazolidin-1-yl)ethyl methacrylate,86261-90-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c970e27-cb61-44a4-9a49-5e4be186f09c/documents/IUC5-c4edd6f4-fc08-41d9-af51-6d847135b656_f65b4e69-1de4-4e19-86bc-37dd184974ff.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-(2-pyridyl)ethanol,103-74-2,"1. Acute oral toxicity (1985), GLP, OECD 401, rats, gavage, 2000 mg/kg, 5000 mg/kg, 8000 mg/kg, LD50 4878 mg/kg bw.2. Acute dermal toxicity (2001), GLP, OECD 402, rats, occlusive, 2000 mg/kg, LD50 > 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92a27720-021e-4716-8ef2-8689b4c9b061/documents/IUC5-30db5c63-c461-49a5-a3bb-97af017fbc6e_e9b83856-33cd-4005-90ab-7b5067a10c8e.html,,,,,, 2-(2-pyridyl)ethanol,103-74-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92a27720-021e-4716-8ef2-8689b4c9b061/documents/IUC5-30db5c63-c461-49a5-a3bb-97af017fbc6e_e9b83856-33cd-4005-90ab-7b5067a10c8e.html,,oral,LD50,"4,878 mg/kg bw",adverse effect observed, 2-(2-pyridyl)ethanol,103-74-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92a27720-021e-4716-8ef2-8689b4c9b061/documents/IUC5-30db5c63-c461-49a5-a3bb-97af017fbc6e_e9b83856-33cd-4005-90ab-7b5067a10c8e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-(3-(4-amino-9,10-dihydro-3-sulpho-9,10-dioxoanthracen-4-yl)aminobenzenesulphonyl)vinyl) disodium sulphate",2580-78-1,"No adverse effects were seen in rats dosed up to the limit dose of 1000 mg/kg bw/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline study ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aabef210-cebe-4630-9435-a0cdceaeebd9/documents/396f1a96-ad74-437b-b223-cb1b2fa86c0d_5b49c570-a818-48bd-b40f-adbb7c0c970c.html,,,,,, "2-(3-(4-amino-9,10-dihydro-3-sulpho-9,10-dioxoanthracen-4-yl)aminobenzenesulphonyl)vinyl) disodium sulphate",2580-78-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aabef210-cebe-4630-9435-a0cdceaeebd9/documents/396f1a96-ad74-437b-b223-cb1b2fa86c0d_5b49c570-a818-48bd-b40f-adbb7c0c970c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-(3-(4-amino-9,10-dihydro-3-sulpho-9,10-dioxoanthracen-4-yl)aminobenzenesulphonyl)vinyl) disodium sulphate",2580-78-1,The oral and dermal LD50 is higher than 2000 mg/kg bw in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aabef210-cebe-4630-9435-a0cdceaeebd9/documents/d867106b-5411-4013-b520-ee294ef7071c_5b49c570-a818-48bd-b40f-adbb7c0c970c.html,,,,,, "2-(3-(4-amino-9,10-dihydro-3-sulpho-9,10-dioxoanthracen-4-yl)aminobenzenesulphonyl)vinyl) disodium sulphate",2580-78-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aabef210-cebe-4630-9435-a0cdceaeebd9/documents/d867106b-5411-4013-b520-ee294ef7071c_5b49c570-a818-48bd-b40f-adbb7c0c970c.html,,oral,LD50,"10,135 mg/kg bw",, "2-(3-(4-amino-9,10-dihydro-3-sulpho-9,10-dioxoanthracen-4-yl)aminobenzenesulphonyl)vinyl) disodium sulphate",2580-78-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aabef210-cebe-4630-9435-a0cdceaeebd9/documents/d867106b-5411-4013-b520-ee294ef7071c_5b49c570-a818-48bd-b40f-adbb7c0c970c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-(3,3-dimethylcyclohex-1-enyl)-2,5,5-trimethyl-1,3-dioxane",1853175-99-1,"Repeated dose toxicity, oral: NOAEL = 10 000 ppm - corresponding to an actual test article intake of 551 and 625 mg/kg/day for males and females, respectively (OECD 422 - diet, GLP, Rel.1) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The key study is GLP-compliant and of high quality (Klimisch score = 1). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a27cedc6-bbfb-435b-9e1a-cf5a966ece8e/documents/1c77accc-092a-4c36-8641-0b58353072ad_a662d9d3-fb79-43d2-8c9d-342c05acc9d7.html,,,,,, "2-(3,3-dimethylcyclohex-1-enyl)-2,5,5-trimethyl-1,3-dioxane",1853175-99-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a27cedc6-bbfb-435b-9e1a-cf5a966ece8e/documents/1c77accc-092a-4c36-8641-0b58353072ad_a662d9d3-fb79-43d2-8c9d-342c05acc9d7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,551 mg/kg bw/day,,rat "2-(3,3-dimethylcyclohex-1-enyl)-2,5,5-trimethyl-1,3-dioxane",1853175-99-1," Oral LD50 > 2000 mg/kg bw (OECD 423, K, Rel.1) Dermal LD50 > 2000 mg/kg bw (OECD 402, K, Rel.1) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a27cedc6-bbfb-435b-9e1a-cf5a966ece8e/documents/54ffb76b-a6f9-4150-ba64-db3786963f08_a662d9d3-fb79-43d2-8c9d-342c05acc9d7.html,,,,,, "2-(3,3-dimethylcyclohex-1-enyl)-2,5,5-trimethyl-1,3-dioxane",1853175-99-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a27cedc6-bbfb-435b-9e1a-cf5a966ece8e/documents/54ffb76b-a6f9-4150-ba64-db3786963f08_a662d9d3-fb79-43d2-8c9d-342c05acc9d7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-(3,3-dimethylcyclohex-1-enyl)-2,5,5-trimethyl-1,3-dioxane",1853175-99-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a27cedc6-bbfb-435b-9e1a-cf5a966ece8e/documents/54ffb76b-a6f9-4150-ba64-db3786963f08_a662d9d3-fb79-43d2-8c9d-342c05acc9d7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-(3,4-epoxycyclohexyl)ethyltriethoxy silane",10217-34-2,"There are two reliable repeated dose toxicity studies, a 28-day and a 90-day oral (gavage) study. The 28-day oral (gavage) study conducted in male and female rats identified a NOEL of 1000 mg/kg/day for the test substance. The 90-day oral (gavage) study conducted in male and female rats produced only some minimal changes which were not accompanied by any evidence of organ dysfunction. Based on these results, a NOAEL of >1000 mg/kg/day was concluded for the test substance. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1326de7-9c35-4b78-ab0f-0c1da0ffc6e5/documents/IUC5-bd6c39cd-b0b1-4c7f-adb3-193647c6c780_f588f954-bfe7-4857-ab01-9c8626da0ff9.html,,,,,, "2-(3,4-epoxycyclohexyl)ethyltriethoxy silane",10217-34-2,"In the acute oral study a LD50 >5000 mg/kg bw has been determined in Albino rats for females and males in a reliable study.In the acute dermal study a LD50 >2000 mg/kg bw has been determined when the substance was applied once for 24 hours to the clipped, intact skin of male and female albino rats in a reliable study. In addition, the 2000 mg/kg dose level was found to be a NOEL for systemic toxicity under the conditions of this study.It was not found to be necessary to perform an acute inhalation study. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1326de7-9c35-4b78-ab0f-0c1da0ffc6e5/documents/IUC5-0f45c348-10c5-49b1-8abb-a7758f14d91d_f588f954-bfe7-4857-ab01-9c8626da0ff9.html,,,,,, "2-(3,4-epoxycyclohexyl)ethyltriethoxy silane",10217-34-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1326de7-9c35-4b78-ab0f-0c1da0ffc6e5/documents/IUC5-0f45c348-10c5-49b1-8abb-a7758f14d91d_f588f954-bfe7-4857-ab01-9c8626da0ff9.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2-(3,4-epoxycyclohexyl)ethyltriethoxy silane",10217-34-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1326de7-9c35-4b78-ab0f-0c1da0ffc6e5/documents/IUC5-0f45c348-10c5-49b1-8abb-a7758f14d91d_f588f954-bfe7-4857-ab01-9c8626da0ff9.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane",3388-04-3," There are no reliable studies on repeated dose toxicity on 2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane, so good quality data for a related substance has been used to assess the oral repeated dose toxicity.  In an oral subchronic toxicity study (NOTOX, 1998) with rats which was conducted according to OECD Guideline 408, the NOAEL for beta-(3,4-epoxycyclohexyl)ethyltriethoxysilane (CAS 10217-34-2) was found to be at least 1000 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1972a4ed-60d9-409a-9c7c-6b38e9328cc1/documents/7b093e3a-739c-4c21-b8d0-e1292418b91c_d9682cbe-986f-4ec7-a350-6b1e2669cc4f.html,,,,,, "2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane",3388-04-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1972a4ed-60d9-409a-9c7c-6b38e9328cc1/documents/7b093e3a-739c-4c21-b8d0-e1292418b91c_d9682cbe-986f-4ec7-a350-6b1e2669cc4f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane",3388-04-3,"An acute oral LD50 of 12.3 ml/kg bw (equivalent to approximately 13161 mg/kg based on a density of 1.07 g/cm3), is reported in a study conducted according to a protocol equivalent to guideline but not in compliance with GLP (Mellon, 1962). No reliable data are available for the inhalation route.    An acute dermal LD50 of 6.30 ml/kg bw (equivalent to 6741 mg/kg bw, based on a density of 1.07 g/cm3), is reported in a study conducted according to a protocol equivalent to guideline but not in compliance with GLP (Mellon Institute, 1962). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study was conducted according to a protocol equivalent to current guideline, but not in compliance with GLP. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1972a4ed-60d9-409a-9c7c-6b38e9328cc1/documents/117ddbc6-a084-43ac-af09-3dbf6932c25d_d9682cbe-986f-4ec7-a350-6b1e2669cc4f.html,,,,,, "2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane",3388-04-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1972a4ed-60d9-409a-9c7c-6b38e9328cc1/documents/117ddbc6-a084-43ac-af09-3dbf6932c25d_d9682cbe-986f-4ec7-a350-6b1e2669cc4f.html,,oral,LD50,"13,161 mg/kg bw",no adverse effect observed, "2-(3,4-epoxycyclohexyl)ethyltrimethoxysilane",3388-04-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1972a4ed-60d9-409a-9c7c-6b38e9328cc1/documents/117ddbc6-a084-43ac-af09-3dbf6932c25d_d9682cbe-986f-4ec7-a350-6b1e2669cc4f.html,,dermal,LD50,"6,741 mg/kg bw",no adverse effect observed, "2-(3,5-Bis(trifluoromethyl)phenyl)-N-(6-chloro-4-(4-fluoro-2-methylphenyl)pyrid-3-yl)-N,2-dimethylpropanamide",825643-73-0,"Male and female Wistar Han (Crl:WI[Han]) rats were assigned to groups and administered test item orally (via gavage) once daily via oral gavage for 28 days at a volume of 10 mL/kg. The vehicle control item was 0.5% Methylcellulose 400cps (w/v), 0.2% Polysorbate 80 (w/v) in Reverse Osmosis (RO) water. Assessment of toxicity was based on mortality, clinical observations, body weights, food consumption, functional observational battery (FOB), locomotor activity (LMA), and clinical and anatomic pathology. Blood samples were collected for potential thyroid hormone analysis. There was no mortality and no test item-related clinical observations. No test item-related alternations in body weight, body weight gain, food consumption, functional observation battery endpoints (sensory reactivity, proprioception, grip strength) or locomotive activity were noted for animals administered up to, and including, 1000 mg/kg/day. No test item-related effects in hematology, coagulation, or clinical chemistry test results were identified for animals administered up to, and including,1000 mg/kg/dose. No test item-related effects in urinalysis test results were noted for animals administered up to, and including, 1000 mg/kg/dose. No test item-related organ weight effects, macroscopic observations, or microscopic findings were noted for animals administered up to 1000 mg/kg/day. In conclusion, oral (gavage) administration of test item to male and female rats for 4 weeks at 100, 300, or 1000 mg/kg/day was well tolerated with no test item related effects. Thus, the no observed effect level (NOEL) is 1000 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26cd6f96-f2ea-47bf-b75b-f9c3ef059379/documents/f346d7eb-070d-458e-aa13-9b901293ca0d_3e425f89-113b-47ee-b138-e237180abbbe.html,,,,,, "2-(3,5-Bis(trifluoromethyl)phenyl)-N-(6-chloro-4-(4-fluoro-2-methylphenyl)pyrid-3-yl)-N,2-dimethylpropanamide",825643-73-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26cd6f96-f2ea-47bf-b75b-f9c3ef059379/documents/f346d7eb-070d-458e-aa13-9b901293ca0d_3e425f89-113b-47ee-b138-e237180abbbe.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-(3,5-Bis(trifluoromethyl)phenyl)-N-(6-chloro-4-(4-fluoro-2-methylphenyl)pyrid-3-yl)-N,2-dimethylpropanamide",825643-73-0,"Oral (Rat-Wistar, females, GLP, acc. to OECD TG423): LD50 > 2000 mg/kg (Stanley, 2024) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26cd6f96-f2ea-47bf-b75b-f9c3ef059379/documents/25f0c784-401c-48bc-ad5e-b686ecd4746d_3e425f89-113b-47ee-b138-e237180abbbe.html,,,,,, "2-(3,5-Bis(trifluoromethyl)phenyl)-N-(6-chloro-4-(4-fluoro-2-methylphenyl)pyrid-3-yl)-N,2-dimethylpropanamide",825643-73-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26cd6f96-f2ea-47bf-b75b-f9c3ef059379/documents/25f0c784-401c-48bc-ad5e-b686ecd4746d_3e425f89-113b-47ee-b138-e237180abbbe.html,,oral,LD50,">=2,000 mg/kg bw",no adverse effect observed, "2-(3,5-Bis(trifluoromethyl)phenyl)-N-(6-chloro-4-(4-fluoro-2-methylphenyl)pyrid-3-yl)-N,2-dimethylpropanamide",825643-73-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26cd6f96-f2ea-47bf-b75b-f9c3ef059379/documents/25f0c784-401c-48bc-ad5e-b686ecd4746d_3e425f89-113b-47ee-b138-e237180abbbe.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2-(3,5-Bis(trifluoromethyl)phenyl)-N-(6-chloro-4-(4-fluoro-2-methylphenyl)pyrid-3-yl)-N,2-dimethylpropanamide",825643-73-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26cd6f96-f2ea-47bf-b75b-f9c3ef059379/documents/25f0c784-401c-48bc-ad5e-b686ecd4746d_3e425f89-113b-47ee-b138-e237180abbbe.html,,inhalation,LC50,"> 5,225 mg/m3",no adverse effect observed, "2-(3,5-dimethylhex-3-en-2-yloxy)-2-methylpropyl cyclopropanecarboxylate",676532-44-8,"NOAEL = no determined (OECD 407, GLP, WoE, rel. 1). NOAEL = 50 mg/kg/day for male and female rats (OECD 407, GLP, WoE, rel. 1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The studies are GLP-compliant and of high quality (Klimisch score = 1). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/014e68dc-8831-4f66-9786-eb1137b7ab38/documents/7ea611f0-a76f-449f-9251-7cfc4b232ec8_b5ea3ab3-0be8-4831-bf8a-b446454380cd.html,,,,,, "2-(3,5-dimethylhex-3-en-2-yloxy)-2-methylpropyl cyclopropanecarboxylate",676532-44-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/014e68dc-8831-4f66-9786-eb1137b7ab38/documents/7ea611f0-a76f-449f-9251-7cfc4b232ec8_b5ea3ab3-0be8-4831-bf8a-b446454380cd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "2-(3,5-dimethylhex-3-en-2-yloxy)-2-methylpropyl cyclopropanecarboxylate",676532-44-8," Oral Oral LD50 > 2000 mg/kg bw (OECD 423, K, Rel.1) Inhalation Not required Dermal Dermal LD50 > 2000 mg/kg bw (OECD 402, K, Rel.1) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/014e68dc-8831-4f66-9786-eb1137b7ab38/documents/00568b72-106b-4b5c-a9fd-c17c0a23ef3a_b5ea3ab3-0be8-4831-bf8a-b446454380cd.html,,,,,, "2-(3,5-dimethylhex-3-en-2-yloxy)-2-methylpropyl cyclopropanecarboxylate",676532-44-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/014e68dc-8831-4f66-9786-eb1137b7ab38/documents/00568b72-106b-4b5c-a9fd-c17c0a23ef3a_b5ea3ab3-0be8-4831-bf8a-b446454380cd.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2-(3,5-dimethylhex-3-en-2-yloxy)-2-methylpropyl cyclopropanecarboxylate",676532-44-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/014e68dc-8831-4f66-9786-eb1137b7ab38/documents/00568b72-106b-4b5c-a9fd-c17c0a23ef3a_b5ea3ab3-0be8-4831-bf8a-b446454380cd.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(S)-2-Hydroxy-3,3-dimethyl-4-butanolide",5405-40-3,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1251bd1f-7d8a-49e5-a152-60e301369b39/documents/IUC5-3a3947f9-65d0-460a-8368-e83a0c30a156_6ba6d1d9-5c48-41ce-944b-117e3cd85ded.html,,oral,LD50,"9,700 mg/kg bw",, "2-(3-hydroxypropyl)-6-[(3-hydroxypropyl)amino]-1H-benz[de]isoquinoline-1,3(2H)-dione",52821-24-6," Acute toxicity: oral The acute toxicity study was predicted using OECD QSAR toolbox version 3.3 (2017); to evaluate the toxic effects of administration of 2-(3-hydroxypropyl)-6- [(3-hydroxy propyl)amino]-1H-benz[de]isoquinoline-1,3(2H)-dione (CAS No. 52821-24-6) in rat by the oral route. 50% mortality observed at 2956.76 mg/kg bw in treated rats. Therefore, the acute oral median lethal dose (LD50) of 2-(3-hydroxypropyl)-6-[(3-hydroxy propyl)amino]-1H- benz[de]isoquinoline-1,3(2H)-dione in rat was estimated to be 2956.76 mg/kg b.wt. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/998064f2-d49e-4004-b23a-59b7fc701467/documents/6ccc8bac-3192-422b-8215-f1bac2b9fd85_b60aada0-3da7-46cb-9b7b-f442bb795ec9.html,,,,,, "2-(3-hydroxypropyl)-6-[(3-hydroxypropyl)amino]-1H-benz[de]isoquinoline-1,3(2H)-dione",52821-24-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/998064f2-d49e-4004-b23a-59b7fc701467/documents/6ccc8bac-3192-422b-8215-f1bac2b9fd85_b60aada0-3da7-46cb-9b7b-f442bb795ec9.html,,oral,LD50,"2,956.76 mg/kg bw",no adverse effect observed, 2-(3-oxazolidinyl)ethyl methacrylate,46235-93-2," An OECD 408, GLP study is available in rats (key study). An additional supporting study is available in dogs. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c278162-71d2-487e-ba8a-b64d35a1267c/documents/ffc48aec-29df-48c0-8cd8-3635309e44d3_07b969c8-1ac5-4cfd-a640-4f4c6ccfdba1.html,,,,,, 2-(3-oxazolidinyl)ethyl methacrylate,46235-93-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c278162-71d2-487e-ba8a-b64d35a1267c/documents/ffc48aec-29df-48c0-8cd8-3635309e44d3_07b969c8-1ac5-4cfd-a640-4f4c6ccfdba1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat 2-(3-oxazolidinyl)ethyl methacrylate,46235-93-2," The key acute oral toxicity study is an OECD 401, GLP study in rats. The key acute dermal toxicity study is an OECD 402, GLP study in rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c278162-71d2-487e-ba8a-b64d35a1267c/documents/35fd27db-f101-493e-b4de-a3b07325d30b_07b969c8-1ac5-4cfd-a640-4f4c6ccfdba1.html,,,,,, 2-(3-oxazolidinyl)ethyl methacrylate,46235-93-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c278162-71d2-487e-ba8a-b64d35a1267c/documents/35fd27db-f101-493e-b4de-a3b07325d30b_07b969c8-1ac5-4cfd-a640-4f4c6ccfdba1.html,,oral,LD50,763 mg/kg bw,adverse effect observed, 2-(3-oxazolidinyl)ethyl methacrylate,46235-93-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c278162-71d2-487e-ba8a-b64d35a1267c/documents/35fd27db-f101-493e-b4de-a3b07325d30b_07b969c8-1ac5-4cfd-a640-4f4c6ccfdba1.html,,dermal,LD50,"1,641 mg/kg bw",adverse effect observed, 2-(3-oxobenzo[b]thien-2(3H)-ylidene)benzo[b]thiophene-3(2H)-one,522-75-8," Repeated dose toxicity: via oral route; The No Observed Adverse Effect Level (NOAEL) for the test chemical for repeated dose toxicity was considered to be in a dose range of 1000-1200 mg/Kg/day in test chemical. Repeated inhalation study: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 3H,3'H-2,2'-bi-1-benzothiophene-3,3'-dione; Thioindigo (522-75-8 ) which is reported as 6.788058e-45 mmHg at 25 C. Also considering the particle size distribution of the substance the majority of the particles was found to be in the size of 150 micron to 53 micron which is much larger size range compared to the inhalable particulate matter .Thus, exposure to inhalable dust, mist and vapour of the chemical 3H,3'H-2,2'-bi-1-benzothiophene-3,3'-dione; Thioindigo (522-75-8 )is highly unlikely. Therefore this study is considered for waiver. Repeated dermal study; The acute toxicity value for 3H,3'H-2,2'-bi-1-benzothiophene-3,3'-dione; Thioindigo (522-75-8 ) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 3H,3'H-2,2'-bi-1-benzothiophene-3,3'-dione; Thioindigo shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 3H,3'H-2,2'-bi-1-benzothiophene-3,3'-dione shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93c55d07-f836-4367-b83a-b40256d40f46/documents/e3209008-84fa-4d98-84a2-0046e254ae02_5362209e-4611-4304-b4bd-26f535f39229.html,,,,,, 2-(3-oxobenzo[b]thien-2(3H)-ylidene)benzo[b]thiophene-3(2H)-one,522-75-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93c55d07-f836-4367-b83a-b40256d40f46/documents/e3209008-84fa-4d98-84a2-0046e254ae02_5362209e-4611-4304-b4bd-26f535f39229.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-(3-oxobenzo[b]thien-2(3H)-ylidene)benzo[b]thiophene-3(2H)-one,522-75-8," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 6.61E-009 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rabbits for the test chemical. The LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93c55d07-f836-4367-b83a-b40256d40f46/documents/b8effb46-7995-43b2-9bef-e808d4f66f03_5362209e-4611-4304-b4bd-26f535f39229.html,,,,,, 2-(3-oxobenzo[b]thien-2(3H)-ylidene)benzo[b]thiophene-3(2H)-one,522-75-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93c55d07-f836-4367-b83a-b40256d40f46/documents/b8effb46-7995-43b2-9bef-e808d4f66f03_5362209e-4611-4304-b4bd-26f535f39229.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-(3-oxobenzo[b]thien-2(3H)-ylidene)benzo[b]thiophene-3(2H)-one,522-75-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93c55d07-f836-4367-b83a-b40256d40f46/documents/b8effb46-7995-43b2-9bef-e808d4f66f03_5362209e-4611-4304-b4bd-26f535f39229.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-(4-(diethylaminopropylcarbamoyl)phenylazo)-3-oxo-N-(2,3-dihydro-2-oxobenzimidazol-5-yl)butyramide",164578-14-7, A 28 day oral toxicity in male and female rats up to 1000 mg/kg bw/d lead to no substance related effects. The NOEL was considered to be 1000 mg/kg bw/. ,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/d46d6af6-28b1-401a-a087-c7113ce1a2b5/documents/9e53131f-3445-4e9a-b50f-f046c7a62db2_f366b878-1a3c-4cfc-bd79-35696add7046.html,,,,,, "2-(4-(diethylaminopropylcarbamoyl)phenylazo)-3-oxo-N-(2,3-dihydro-2-oxobenzimidazol-5-yl)butyramide",164578-14-7,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/d46d6af6-28b1-401a-a087-c7113ce1a2b5/documents/9e53131f-3445-4e9a-b50f-f046c7a62db2_f366b878-1a3c-4cfc-bd79-35696add7046.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-(4-(diethylaminopropylcarbamoyl)phenylazo)-3-oxo-N-(2,3-dihydro-2-oxobenzimidazol-5-yl)butyramide",164578-14-7," Acute toxicity after single oral application was tested in male and female rats, which received 2000 mg/kg bw (5 males, 5 females). All animals survived until the end of the study without showing any signs of toxicity. Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain. At necropsy, no macroscopic findings were observed. The LD50 value for acute oral toxicity is > 2000 mg/kg bw. A single dermal application of the test item to 10 rats (5 males and 5 females) at a dose of 2000 mg/kg bw was associated with no mortality and neither clinical signs. The dermal LD50 was determined to be > 2000 mg/kg bw The studies were carried out according to OECD guidelines 401 and 402. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d46d6af6-28b1-401a-a087-c7113ce1a2b5/documents/b7585a57-4fb0-4ea6-835a-bd54b8ea317b_f366b878-1a3c-4cfc-bd79-35696add7046.html,,,,,, "2-(4-(diethylaminopropylcarbamoyl)phenylazo)-3-oxo-N-(2,3-dihydro-2-oxobenzimidazol-5-yl)butyramide",164578-14-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d46d6af6-28b1-401a-a087-c7113ce1a2b5/documents/b7585a57-4fb0-4ea6-835a-bd54b8ea317b_f366b878-1a3c-4cfc-bd79-35696add7046.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-(4-(diethylaminopropylcarbamoyl)phenylazo)-3-oxo-N-(2,3-dihydro-2-oxobenzimidazol-5-yl)butyramide",164578-14-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d46d6af6-28b1-401a-a087-c7113ce1a2b5/documents/b7585a57-4fb0-4ea6-835a-bd54b8ea317b_f366b878-1a3c-4cfc-bd79-35696add7046.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(3-((2-ethylhexyl)oxy)-2-hydroxypropoxy)phenol",137658-79-8,"In a 28 d study performed in rat (GLP-compliant, OECD guideline 407), the substance did not cause mortalities, signs of toxicity or any other changes or abnormalities. The NOEL/NOAEL is considered to be 1000 mg/kg bw/d. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25d082d9-d328-4f62-ab1f-1b3874031295/documents/78cfbe5e-c8ad-4f7b-89ea-6c02078dc959_e36b5ceb-dae2-47e4-b882-fa3fb7c18029.html,,,,,, "2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(3-((2-ethylhexyl)oxy)-2-hydroxypropoxy)phenol",137658-79-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25d082d9-d328-4f62-ab1f-1b3874031295/documents/78cfbe5e-c8ad-4f7b-89ea-6c02078dc959_e36b5ceb-dae2-47e4-b882-fa3fb7c18029.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(3-((2-ethylhexyl)oxy)-2-hydroxypropoxy)phenol",137658-79-8,"A single dose of 2000 mg/kg bw of the test substance was administrated oral or dermal to groups of male and female rats (5/sex, according to OECD guidelines 401 and 402). Application of the test substance did not induce any signs of toxicity. None of the animals died, viability and bodyweight gain were unaffected by the test article. Gross necropsy did not reveal any treatment related abnormalities. LD50 after single oral and dermal administration is > 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25d082d9-d328-4f62-ab1f-1b3874031295/documents/50bc9910-4d02-4d7e-9eb7-1578b27ff469_e36b5ceb-dae2-47e4-b882-fa3fb7c18029.html,,,,,, "2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(3-((2-ethylhexyl)oxy)-2-hydroxypropoxy)phenol",137658-79-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25d082d9-d328-4f62-ab1f-1b3874031295/documents/50bc9910-4d02-4d7e-9eb7-1578b27ff469_e36b5ceb-dae2-47e4-b882-fa3fb7c18029.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-(4,6-bis(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(3-((2-ethylhexyl)oxy)-2-hydroxypropoxy)phenol",137658-79-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25d082d9-d328-4f62-ab1f-1b3874031295/documents/50bc9910-4d02-4d7e-9eb7-1578b27ff469_e36b5ceb-dae2-47e4-b882-fa3fb7c18029.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-(4,6-bis-(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(octyloxy)-phenol",2725-22-6," Repeated Dose Toxicity: Oral Based on the available results and applying the weight of evidence approach, the test chemical can be considered to be non-toxic to living organisms when dosed repeatedly via oral route. The No Observed Adverse Effect Level can be considered to be >1000 mg/kgbw/day. Comparing the above annotations with the criteria of CLP Regulation, the test chemical can be classified under the category “Not Classified”. Repeated Dose toxicity: Inhalation A short-term toxicity study need not be conducted as because exposure of humans via inhalation route in production and/or use is not likely based on the provided thorough and rigorous exposure.The estimated vapour pressure of test chemical at 25 deg C was observed to be 2.08E-17 mmHg (2.78E-15 Pa) Hence, this endpoint was considered for waiver. Repeated Dose Toxicity: Dermal A short-term toxicity study need not be conducted as because exposure of humans via dermal route in production and/or use is not likely based on the provided thorough and rigorous exposure assessment. The acute dermal toxicity value for the test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance failed to cause any dermal irritation as well sensitization. Considering this, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6410773-453b-473c-9ed2-5ca7a01850af/documents/01938bb5-9dae-4b72-9369-8b09813b9608_f1706af1-b9d5-4b74-ae1c-f6d055f2790c.html,,,,,, "2-(4,6-bis-(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(octyloxy)-phenol",2725-22-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6410773-453b-473c-9ed2-5ca7a01850af/documents/01938bb5-9dae-4b72-9369-8b09813b9608_f1706af1-b9d5-4b74-ae1c-f6d055f2790c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-(4,6-bis-(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(octyloxy)-phenol",2725-22-6," Acute oral toxicity: Acute oral toxicity study was performed according to OECD Guideline 401 (Acute Oral Toxicity) to determine the toxic nature of test chemical on rats. An LD50 of >5000 mg/kg bw was determined indicating that the test chemical is not toxic in nature and falls under category ‘Not classified’. Acute Dermal toxicity: Acute dermal toxicity study was performed to determine the toxic nature of test chemical on rabbits. An LD50 of >10000 mg/kg bw was determined indicating that the test chemical is not toxic in nature and falls under category ‘Not classified’. Acute Inhalation toxicity: An acute inhalation toxicity study need not be conducted as because exposure of humans via inhalation route in production and/or use is not likely based on the provided thorough and rigorous exposure.The estimated vapour pressure of test chemical at 25 deg C was observed to be 2.08E-17 mmHg (2.78E-15 Pa). Hence, this endpoint was considered for waiver. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6410773-453b-473c-9ed2-5ca7a01850af/documents/5a24c772-d6a0-4c08-98b1-9b91f5027de9_f1706af1-b9d5-4b74-ae1c-f6d055f2790c.html,,,,,, "2-(4,6-bis-(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(octyloxy)-phenol",2725-22-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6410773-453b-473c-9ed2-5ca7a01850af/documents/5a24c772-d6a0-4c08-98b1-9b91f5027de9_f1706af1-b9d5-4b74-ae1c-f6d055f2790c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-(4,6-bis-(2,4-dimethylphenyl)-1,3,5-triazin-2-yl)-5-(octyloxy)-phenol",2725-22-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6410773-453b-473c-9ed2-5ca7a01850af/documents/5a24c772-d6a0-4c08-98b1-9b91f5027de9_f1706af1-b9d5-4b74-ae1c-f6d055f2790c.html,,dermal,LD50,"10,000 mg/kg bw",no adverse effect observed, "2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-((hexyl)oxy)phenol",147315-50-2," In a 28 d study performed in rat (according GLP and OECD guideline 407), the substance did not induce mortalities, signs of toxicity or any other changes or abnormalities. The NOAEL/NOEL is considered to be 1090 mg/kg bw/d in females and 1130 mg/kg bw/d in males. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78df0958-1803-43a7-8dc5-55e2d7ec214e/documents/28e172f1-e2c5-459a-84af-f02a3fc98890_a8910596-7724-46eb-b85c-86aa9b20b27e.html,,,,,, "2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-((hexyl)oxy)phenol",147315-50-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78df0958-1803-43a7-8dc5-55e2d7ec214e/documents/28e172f1-e2c5-459a-84af-f02a3fc98890_a8910596-7724-46eb-b85c-86aa9b20b27e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,090 mg/kg bw/day",,rat "2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-((hexyl)oxy)phenol",147315-50-2," A single dose of 2000 mg/kg bw of the test substance was administrated oral to groups of male and female rats (5/sex, OECD guideline 401). A limit dose of 1333 mg/kg bw (high siziness when mixed with vehicle) was applied dermally to groups of male and female rats (5/sex, OECD guideline 402). Application of the test substance did not induce any signs of toxicity. None of the animals died, viability and bodyweight gain were unaffected by the test article. Gross necropsy did not reveal any treatment related abnormalities. LD50 after single oral administration is > 2000 mg/kg bw, LD50 acute dermal > 1333 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78df0958-1803-43a7-8dc5-55e2d7ec214e/documents/268652b9-b423-4086-afd1-cc078e3e3a25_a8910596-7724-46eb-b85c-86aa9b20b27e.html,,,,,, "2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-((hexyl)oxy)phenol",147315-50-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78df0958-1803-43a7-8dc5-55e2d7ec214e/documents/268652b9-b423-4086-afd1-cc078e3e3a25_a8910596-7724-46eb-b85c-86aa9b20b27e.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-(4,6-diphenyl-1,3,5-triazin-2-yl)-5-((hexyl)oxy)phenol",147315-50-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78df0958-1803-43a7-8dc5-55e2d7ec214e/documents/268652b9-b423-4086-afd1-cc078e3e3a25_a8910596-7724-46eb-b85c-86aa9b20b27e.html,,dermal,discriminating dose,"1,333 mg/kg bw",no adverse effect observed, 2-(4-aminoanilino)-5-nitrobenzenesulphonic acid,91-29-2," Repeated dose toxicity: Oral 28 days subacute repeated dose oral toxicity study was performed to determine the oral toxic nature of 4-nitro-4’-aminodiphenylamine-2-sulfonic acid. The study was performed using Wistar rats as per the OECD guideline no 407. 5 male and 5 female rats recieved feed at dosage of 0, 480, 2400 or 12000 mg/Kg containing an average daily substance intake of 0, 50, 243 or 1253 mg/Kg bw in male rats and 0, 47, 234 or 1191 mg/Kg bw in female rats. All animals were observed for clinical symtoms, mortality, hematological and clinical chemistry parameters, urinanalysis, and were subjected to gross and histopathological observations. All animals well tolerated the highest dose and did not show any signs at the highest dose level corresponding to 1253 mg/Kg bw for male rats and 1191 mg/Kg bw for female rats. No changes were noted in hematological and clinical chemistry parameters. Urinanalysis represented brown discoloration of urine in the highest dose group (1253 mg/Kg bw for males and 1191 mg/Kg bw for females). 2 male rats of 2400 mg/Kg bw feed group and all male rats of 12000 mg/Kg feed group exhibited ocherous kidneys. No cases of histopathological observations were made. On the basis of observations made, the No Observed Adverse Effect level for the test substance 4-nitro-4’-aminodiphenylamine-2-sulfonic acid is considered to be 1253 mg/Kg bw in male rats and 1191 mg/Kg bw in female rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a887e532-cc8b-4542-bb16-2777e16664a6/documents/2df323ca-8616-4213-b107-162adcbc046f_0ff69160-70d9-479c-af62-71d98b87dd5d.html,,,,,, 2-(4-aminoanilino)-5-nitrobenzenesulphonic acid,91-29-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a887e532-cc8b-4542-bb16-2777e16664a6/documents/2df323ca-8616-4213-b107-162adcbc046f_0ff69160-70d9-479c-af62-71d98b87dd5d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,253 mg/kg bw/day",,rat 2-(4-aminoanilino)-5-nitrobenzenesulphonic acid,91-29-2," Acute oral toxicity: LD50 was considered to be>5000mg/kg whenrats were treated with 4-nitro-4’ aminodiphenylamine-2-sulfonic acid(91-29-2), orally.    Acute dermal toxicity:  LD50 was considered to be > 2000mg/kg bw when rats were treated with 4-nitro-4’ aminodiphenylamine-2-sulfonic acid(91-29-2), on dermal application ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a887e532-cc8b-4542-bb16-2777e16664a6/documents/306f125f-aa38-49c2-88f8-fb0d5b57e68a_0ff69160-70d9-479c-af62-71d98b87dd5d.html,,,,,, 2-(4-aminoanilino)-5-nitrobenzenesulphonic acid,91-29-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a887e532-cc8b-4542-bb16-2777e16664a6/documents/306f125f-aa38-49c2-88f8-fb0d5b57e68a_0ff69160-70d9-479c-af62-71d98b87dd5d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-(4-aminoanilino)-5-nitrobenzenesulphonic acid,91-29-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a887e532-cc8b-4542-bb16-2777e16664a6/documents/306f125f-aa38-49c2-88f8-fb0d5b57e68a_0ff69160-70d9-479c-af62-71d98b87dd5d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-(4-aminophenyl)butanoic acid,29644-97-1, Oral: The oral LD50 value of the test item in Wistar rat was established to exceed 2000 mg/kg bw. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a772546a-7150-4c7f-829e-478bfed25293/documents/36e878e7-ac44-4b5d-9e73-b0eeb60752ea_c41533b6-0be1-468d-b5dd-3f89e63172e0.html,,,,,, 2-(4-aminophenyl)butanoic acid,29644-97-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a772546a-7150-4c7f-829e-478bfed25293/documents/36e878e7-ac44-4b5d-9e73-b0eeb60752ea_c41533b6-0be1-468d-b5dd-3f89e63172e0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-(4-bromo-3-hydroxy-2-quinolyl)-1H-indene-1,3(2H)-dione",10319-14-9,The potential of the substance for acute toxicity following oral administration was tested in male and female rats of the CFY strain; LD50 is 11400 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bd0cac6-f2ee-4330-a3a5-95778d6d4094/documents/c64e1229-5ad1-41f7-a778-c478125dbf66_f9620b5c-90df-4b65-8f2c-f86a7577dc7d.html,,,,,, "2-(4-bromo-3-hydroxy-2-quinolyl)-1H-indene-1,3(2H)-dione",10319-14-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bd0cac6-f2ee-4330-a3a5-95778d6d4094/documents/c64e1229-5ad1-41f7-a778-c478125dbf66_f9620b5c-90df-4b65-8f2c-f86a7577dc7d.html,,oral,LD50,"11,400 mg/kg bw",no adverse effect observed, "2-(4-Bromphenyl)-5-butyl-1,3-dioxane, trans-",1310048-86-2, GLP compliant OECD 423: LD50 (oral) > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/313e2aba-a591-4cb9-9691-ab63489e4db6/documents/7c35f6ce-92a0-487c-94dd-e542cdf3b7b2_0a2bd1a7-bf2c-4bb5-849f-9ce423ddb829.html,,,,,, "2-(4-Bromphenyl)-5-butyl-1,3-dioxane, trans-",1310048-86-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/313e2aba-a591-4cb9-9691-ab63489e4db6/documents/7c35f6ce-92a0-487c-94dd-e542cdf3b7b2_0a2bd1a7-bf2c-4bb5-849f-9ce423ddb829.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-(4-chloro-2,6-dimethylphenyl)acetic acid",186748-50-5,"No experimental data on acute toxicity of the test item is available. An in silico and read-across prediction for acute oral toxicity was conducted on Feb 6, 2024 using four different tools (DEREK, Leadscope, EPA TEST, OECD TB). The test item was predicted to have an acute oral toxicity and shall be classified with Cat. 4. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/723e358d-c69d-4da0-a3ec-b98c172f787f/documents/0de3daf4-363a-4da7-a0bb-f92da1b15220_8b1e6753-a562-4517-8d9f-d41c9a9c5493.html,,,,,, 2-(4-chlorobenzoyl)benzoic acid,85-56-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1bfa08a7-72c9-4b5e-9481-bda9f62fabb9/documents/2a267ab0-2880-49d0-b9dc-70e22170fa57_fba5cb22-3d35-4fc7-94e5-9496d29396fc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 2-(4-chlorobenzoyl)benzoic acid,85-56-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): between 300 and 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bfa08a7-72c9-4b5e-9481-bda9f62fabb9/documents/7c38ba64-0572-4a5f-853e-773212027f09_fba5cb22-3d35-4fc7-94e5-9496d29396fc.html,,,,,, 2-(4-chlorobenzoyl)benzoic acid,85-56-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bfa08a7-72c9-4b5e-9481-bda9f62fabb9/documents/7c38ba64-0572-4a5f-853e-773212027f09_fba5cb22-3d35-4fc7-94e5-9496d29396fc.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "3,5-Pyridinedicarboxylic acid, 1,4-dihydro-2,6-dimethyl-4-(3-nitrophenyl)-, 2-(4-(diphenylmethyl)-1-piperazinyl)ethyl methyl ester",89226-50-6,LD50 oral rat: 156 mg/Kg LD50 oral mouse: 171 mg/Kg Data on the substance Manidipien hydrochloride CAS 89226-75-5. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce9b764c-f224-4d06-8298-bb4c68443e74/documents/083542cc-1c45-4919-972e-8749f94c9570_88278a58-06fe-4510-ac86-828d87fa388f.html,,,,,, 2-(4-methylpentan-2-yl)aniline,203448-76-4,"Acute toxicity: oral (rats, OECD TG 423): LD50: > 2000 mg/kg b.w.The acute oral toxicity to female Wistar rats of the test item was assessed. The test compound was formulated in tap water with the aid of PEG 400, the administration volume was 10 mL/kg body weight. The starting dose of the test item was 2000 mg/kg bw. According to the OECD guideline 423 the LD50 of the test item is > 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/adcd1369-f578-41af-9c4a-8bd32ec5d949/documents/5ec79cd6-377a-4386-aa46-e16f49bbcc94_b8f89049-9679-4be1-b6fe-277e869b3d11.html,,,,,, 2-(4-methylpentan-2-yl)aniline,203448-76-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/adcd1369-f578-41af-9c4a-8bd32ec5d949/documents/5ec79cd6-377a-4386-aa46-e16f49bbcc94_b8f89049-9679-4be1-b6fe-277e869b3d11.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-(4-methylphenoxy)-N-(1H-pyrazol-3-yl)-N-[(thiophen-2-yl)methyl]acetamide,1374760-95-8," Repeated dose toxicity oral: NOAEL ≥ 100 mg/kg bw/d (similar to OECD 408, GLP, K, rel. 2) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4746cae-193f-4bba-ae84-e19c1f10326e/documents/67d53c65-baaf-4f45-8d24-efee0e4822ff_8e05ba2d-a42f-404d-b2c3-ef99543e13f9.html,,,,,, 2-(4-methylphenoxy)-N-(1H-pyrazol-3-yl)-N-[(thiophen-2-yl)methyl]acetamide,1374760-95-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4746cae-193f-4bba-ae84-e19c1f10326e/documents/67d53c65-baaf-4f45-8d24-efee0e4822ff_8e05ba2d-a42f-404d-b2c3-ef99543e13f9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 2-(4-methylphenoxy)-N-(1H-pyrazol-3-yl)-N-[(thiophen-2-yl)methyl]acetamide,1374760-95-8," Acute toxicity: oral: LD50 > 5000 mg/kg bw (OECD 420 in rats, K, rel.1) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4746cae-193f-4bba-ae84-e19c1f10326e/documents/ab6af997-d7a3-47a2-a3bd-9b3049cbc5c9_8e05ba2d-a42f-404d-b2c3-ef99543e13f9.html,,,,,, 2-(4-methylphenoxy)-N-(1H-pyrazol-3-yl)-N-[(thiophen-2-yl)methyl]acetamide,1374760-95-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4746cae-193f-4bba-ae84-e19c1f10326e/documents/ab6af997-d7a3-47a2-a3bd-9b3049cbc5c9_8e05ba2d-a42f-404d-b2c3-ef99543e13f9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "1H-pyrrolo[1,2-b][1,2,4]triazole-7-carboxylic acid, 5-[[[bis(2-ethoxy-2-oxoethyl)amino]carbonyl]oxy]-6-cyano-2-[4-(1,1-dimethylethyl)phenyl]-2,6-bis(1,1-dimethylethyl)-4-methylcyclohexyl ester",444065-11-6,"Oral (OECD 407), rat: NOAEL 1000 mg/kg bw/dayInhalation: not applicable (endpoint waived)Dermal: not applicable (endpoint waived) ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b2f0c8a-ffea-4326-9930-3feae6d6bd37/documents/IUC5-35159c19-dd83-4466-b0cd-f67704af9d96_4fece6f5-26ae-4699-a361-0f910316d4e7.html,,,,,, "1H-pyrrolo[1,2-b][1,2,4]triazole-7-carboxylic acid, 5-[[[bis(2-ethoxy-2-oxoethyl)amino]carbonyl]oxy]-6-cyano-2-[4-(1,1-dimethylethyl)phenyl]-2,6-bis(1,1-dimethylethyl)-4-methylcyclohexyl ester",444065-11-6,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b2f0c8a-ffea-4326-9930-3feae6d6bd37/documents/IUC5-35159c19-dd83-4466-b0cd-f67704af9d96_4fece6f5-26ae-4699-a361-0f910316d4e7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1H-pyrrolo[1,2-b][1,2,4]triazole-7-carboxylic acid, 5-[[[bis(2-ethoxy-2-oxoethyl)amino]carbonyl]oxy]-6-cyano-2-[4-(1,1-dimethylethyl)phenyl]-2,6-bis(1,1-dimethylethyl)-4-methylcyclohexyl ester",444065-11-6,"Oral (OECD 423), rat: LD50 = 5000 mg/kg bw (limit test)Inhalation (OECD 403), rat: LD50 > 5.05 mg/L (limit test)Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw (limit test) ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b2f0c8a-ffea-4326-9930-3feae6d6bd37/documents/IUC5-2d3dae42-7a1b-4a70-9462-cca2772a5c3b_4fece6f5-26ae-4699-a361-0f910316d4e7.html,,,,,, "1H-pyrrolo[1,2-b][1,2,4]triazole-7-carboxylic acid, 5-[[[bis(2-ethoxy-2-oxoethyl)amino]carbonyl]oxy]-6-cyano-2-[4-(1,1-dimethylethyl)phenyl]-2,6-bis(1,1-dimethylethyl)-4-methylcyclohexyl ester",444065-11-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b2f0c8a-ffea-4326-9930-3feae6d6bd37/documents/IUC5-2d3dae42-7a1b-4a70-9462-cca2772a5c3b_4fece6f5-26ae-4699-a361-0f910316d4e7.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-(6-methoxybenzofuran-2-yl)-1,3-dimethyl-5-(methylsulphonyl)1H-benzimidazolium acetate",74878-48-1," NOAEL (subacute, rat M/F) ≥ 750 mg/kg bw/day, based on systemic toxicity ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9bed63b-6a77-4350-8087-6e58b340d2c5/documents/e4a8c0b1-9f3a-40eb-ae90-77540112dc0e_7d7615fd-c6ab-45dd-bf94-fd6425b59c75.html,,,,,, "2-(6-methoxybenzofuran-2-yl)-1,3-dimethyl-5-(methylsulphonyl)1H-benzimidazolium acetate",74878-48-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9bed63b-6a77-4350-8087-6e58b340d2c5/documents/e4a8c0b1-9f3a-40eb-ae90-77540112dc0e_7d7615fd-c6ab-45dd-bf94-fd6425b59c75.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "2-(6-methoxybenzofuran-2-yl)-1,3-dimethyl-5-(methylsulphonyl)1H-benzimidazolium acetate",74878-48-1," The acute oral LD50 and the acute inhalation LC50 of test item were considered to be >8000 mg/kg bw and > 2130 mg/m³, respectively. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9bed63b-6a77-4350-8087-6e58b340d2c5/documents/59acbc0d-a370-47cf-a3f2-d9abbff4b431_7d7615fd-c6ab-45dd-bf94-fd6425b59c75.html,,,,,, "2-(6-methoxybenzofuran-2-yl)-1,3-dimethyl-5-(methylsulphonyl)1H-benzimidazolium acetate",74878-48-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9bed63b-6a77-4350-8087-6e58b340d2c5/documents/59acbc0d-a370-47cf-a3f2-d9abbff4b431_7d7615fd-c6ab-45dd-bf94-fd6425b59c75.html,,oral,LD50,"7,700 mg/kg bw",no adverse effect observed, 2-(acetylamino)-N-benzyl-3-methoxypropanamide,175481-26-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e92a7ae-ca1e-4083-916b-6b081719c451/documents/ebadb664-8f62-49c9-b080-02f91d68d4b5_36efd0a3-9779-4265-8f2a-dc013bf95c57.html,Chronic toxicity – systemic effects,oral,NOAEL,90 mg/kg bw/day,,rat 2-(allyloxy)ethanol,111-45-5,"In an acute oral toxicity study according to OECD guideline 423 the determined LD50 of the test item is 500 mg/kg bw in rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable without restrictions ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca16270e-5935-4a02-bf57-3f7b99417bfe/documents/d5d6bd7b-f2a7-4b62-9bfd-413b07d63f63_0bb08135-8ddc-47e0-b74a-4f9a64c3be5c.html,,,,,, 2-(allyloxy)ethanol,111-45-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca16270e-5935-4a02-bf57-3f7b99417bfe/documents/d5d6bd7b-f2a7-4b62-9bfd-413b07d63f63_0bb08135-8ddc-47e0-b74a-4f9a64c3be5c.html,,oral,LD50,500 mg/kg bw,adverse effect observed, 2-(butylnitroamino)ethyl nitrate,82486-82-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Correct Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Correct ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01812b31-569a-4ff1-964d-b4b63a637fe3/documents/68c49f50-4b77-4f35-a021-e7137fc117c7_fe22bf29-2327-4758-b450-c0fc26ff6543.html,,,,,, 2-(butylnitroamino)ethyl nitrate,82486-82-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01812b31-569a-4ff1-964d-b4b63a637fe3/documents/68c49f50-4b77-4f35-a021-e7137fc117c7_fe22bf29-2327-4758-b450-c0fc26ff6543.html,,oral,LD50,300 mg/kg bw,adverse effect observed, 2-(butylnitroamino)ethyl nitrate,82486-82-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01812b31-569a-4ff1-964d-b4b63a637fe3/documents/68c49f50-4b77-4f35-a021-e7137fc117c7_fe22bf29-2327-4758-b450-c0fc26ff6543.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-(cyclohexylamino)ethanesulphonic acid,103-47-9," In a GLP-study according to OECD TG 423 (acute toxic class method) with rats, the LD50 of the substance was determined as > 2000 mg/kg bw (reference 7.2.1 -1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b2147e9-9ffa-46c0-8f4c-e2a4488af9cd/documents/811477a7-900d-450e-a8e3-dd96bf0ac242_8b1a9bad-15a6-4258-afa0-89119e4b652d.html,,,,,, 2-(cyclohexylamino)ethanesulphonic acid,103-47-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b2147e9-9ffa-46c0-8f4c-e2a4488af9cd/documents/811477a7-900d-450e-a8e3-dd96bf0ac242_8b1a9bad-15a6-4258-afa0-89119e4b652d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-(dimethylamino)ethyl acrylate,2439-35-2,"According to two repeated dose studies by oral administration in rats, the findings at or more than 50 mg/kg/day were considered toxicologically significant. The test substance was not toxic at 20 mg/kg/day in both sexes in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (MHW Japan, 1998). Nevertheless, the NOAEL was considered to be 10 mg/kg/day in a 90-day study (Atochem, 1999). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/59e43c46-fc88-4cf9-8365-e38bee384ae2/documents/IUC5-42453f41-237d-49f1-8fc7-c4c9a5dba24e_edb1696d-68e6-4855-8cd8-07c110d4d7a4.html,,,,,, 2-(dimethylamino)ethyl acrylate,2439-35-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/59e43c46-fc88-4cf9-8365-e38bee384ae2/documents/IUC5-42453f41-237d-49f1-8fc7-c4c9a5dba24e_edb1696d-68e6-4855-8cd8-07c110d4d7a4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat 2-(dimethylamino)ethyl acrylate,2439-35-2,"Based on mortality data at doses of 80 - 2000 mg/kg, the acute oral LD50 of this substance is considered to be 455 mg/kg bw (Atochem, 1989). Toxicity was recognised immediately after dosing.Based on mortality data at doses of 200 - 2000 mg/kg, the acute dermal LD50 of this substance is considered to be 419 mg/kg bw (Atochem, 1989). Toxicity was recognised immediately after dosing.Based on mortality data at concentrations of 0.11 - 1.08 mg/L, the acute inhalation LC50 of this substance is considered to be 220 mg/m³ (BASF AG, 1979). The LC0 was estimated to be 90 mg/m³. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59e43c46-fc88-4cf9-8365-e38bee384ae2/documents/IUC5-e7131cb9-fad3-4482-8dc5-3ee3633ecd71_edb1696d-68e6-4855-8cd8-07c110d4d7a4.html,,,,,, 2-(dimethylamino)ethyl acrylate,2439-35-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59e43c46-fc88-4cf9-8365-e38bee384ae2/documents/IUC5-e7131cb9-fad3-4482-8dc5-3ee3633ecd71_edb1696d-68e6-4855-8cd8-07c110d4d7a4.html,,oral,LD50,455 mg/kg bw,, 2-(dimethylamino)ethyl acrylate,2439-35-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59e43c46-fc88-4cf9-8365-e38bee384ae2/documents/IUC5-e7131cb9-fad3-4482-8dc5-3ee3633ecd71_edb1696d-68e6-4855-8cd8-07c110d4d7a4.html,,dermal,LD50,419 mg/kg bw,, 2-(dimethylamino)ethyl acrylate,2439-35-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59e43c46-fc88-4cf9-8365-e38bee384ae2/documents/IUC5-e7131cb9-fad3-4482-8dc5-3ee3633ecd71_edb1696d-68e6-4855-8cd8-07c110d4d7a4.html,,inhalation,LC50,220 mg/m3,, 2-(ethylnitroamino)ethyl nitrate,85068-73-1," Acute oral toxicity: Key study. Test method according to OECD 423, GLP study. The oral LD50 of the test item in female rats was found to be greater than 300 mg/kg bw and lower than 2000 mg/kg bw. The LD50 cut-off of the test item may be considered to be 500 mg/kg bw. Acute dermal toxicity: Key study. Test method similar to OECD 402, GLP study. The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in rabbits. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/572742a2-0282-4b21-b197-345cbb8d9821/documents/da40a377-5f23-464a-8610-877ee97d7174_26504650-8926-4b24-bb2c-a260b414625d.html,,,,,, 2-(ethylnitroamino)ethyl nitrate,85068-73-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/572742a2-0282-4b21-b197-345cbb8d9821/documents/da40a377-5f23-464a-8610-877ee97d7174_26504650-8926-4b24-bb2c-a260b414625d.html,,oral,LD50,500 mg/kg bw,adverse effect observed, 2-(ethylnitroamino)ethyl nitrate,85068-73-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/572742a2-0282-4b21-b197-345cbb8d9821/documents/da40a377-5f23-464a-8610-877ee97d7174_26504650-8926-4b24-bb2c-a260b414625d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-(hydroxymethylamino)ethanol,34375-28-5," Repeated dose oral toxicity: Repeated dose dermal toxicity study was performed to determine the oral toxic nature of Ethanol, 2-(hydroxymethylamino). The study was performed using 25 female Sprague Dawley rats at dose levels of 0, 250, 500 or 1000 mg/Kg bw. The chemical was dissolved in distilled water. The animals were observed clinical signs, changes in body weight and food consumption, gross and histopathology was performed. Under the conditions of this study, no effect was seen on the rats, at dose levels of up to 250 mg/kg/day. Repeated dose toxicity was observed at 500 mg/kg/day indicated by gastro-intestinal abnormalities, reduced body weight gain and reduced food consumption during the treatment period. Hence theNo Observed Adverse Effect Level (NOAEL) for the test compoundEthanol, 2-(hydroxymethylamino) is 250 mg/Kg bw. Repeated dose dermal toxicity: 13 weeks repeated dose toxicity (dermal) study of Ethanol, 2-(hydroxymethylamino) was conducted in Sprague-Dawley rats according to US EPA Pesticide Assessment Guidelines Subdivision F, 82-3. The test chemical was dissolved in distilled water and used at dose levels of 0, 50, 250 or 1000 mg/Kg. The chemical was applied daily (Monday – Friday) at a constant volume of 2 ml/kg over an area of approximately 10% of the total body surface area. The treated area was protected for approximately 6 hours by an occlusive dressing held in place by means of nonirritating tape. The animals were observed for mortality, clinical signs, changes in body weight, water and food consumpton, opthamological, hematological and clinical chemistry signs were recorded and the animals underwent gross and histo- pathology. There was one premature death (male at 250 mg/kg/day dose), which was not considered due to treatment with the test material. No dose related changes in body weight, water and food consumption, ophthalmology and no notable hematological intergroup differences were noted. The most notable clinical signs included scabbing on and yellow staining around the dosing site was observed, which were seen in all dose groups that received the test material. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for Ethanol, 2 (hydroxymethylamino) is 1000 mg/kg/day when applied dermally to male and female Sprague-Dawley rats. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/abb94b79-f0e7-4aa6-922f-90ec47c30638/documents/138b9141-2455-4bee-9f7e-11818d911a49_879865aa-9787-4ca6-b5b3-6389f6e26ed8.html,,,,,, 2-(hydroxymethylamino)ethanol,34375-28-5,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/abb94b79-f0e7-4aa6-922f-90ec47c30638/documents/138b9141-2455-4bee-9f7e-11818d911a49_879865aa-9787-4ca6-b5b3-6389f6e26ed8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 2-(hydroxymethylamino)ethanol,34375-28-5,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/abb94b79-f0e7-4aa6-922f-90ec47c30638/documents/138b9141-2455-4bee-9f7e-11818d911a49_879865aa-9787-4ca6-b5b3-6389f6e26ed8.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat 2-(hydroxymethylamino)ethanol,34375-28-5, LD50 was considered to be 1620 mg/kg (1069-2455) for amle and 1956 mg/kg (1110-3093) for female when Sprague-Dawley male and female rat were treated with 2-[hydroxy(methyl)amino]ethanol orally by gavage. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abb94b79-f0e7-4aa6-922f-90ec47c30638/documents/603e8ca2-2091-4d34-8ec6-b7ff61e7f2f1_879865aa-9787-4ca6-b5b3-6389f6e26ed8.html,,,,,, 2-(hydroxymethylamino)ethanol,34375-28-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abb94b79-f0e7-4aa6-922f-90ec47c30638/documents/603e8ca2-2091-4d34-8ec6-b7ff61e7f2f1_879865aa-9787-4ca6-b5b3-6389f6e26ed8.html,,oral,LD50,"1,620 mg/kg bw",adverse effect observed, "2-(isopropylthio)-3-(2,2,2-trifluoroethoxy)pyridine",256473-05-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6680fde-b1ae-42e8-a867-c2ef2357ddb4/documents/IUC5-be0e3cc4-023e-4ace-b1a2-bdee7782528b_44055eb1-4b77-44d9-a6ad-516405f963b1.html,,oral,LD50,"2,000 mg/kg bw",, "2-(isopropylthio)-3-(2,2,2-trifluoroethoxy)pyridine",256473-05-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6680fde-b1ae-42e8-a867-c2ef2357ddb4/documents/IUC5-be0e3cc4-023e-4ace-b1a2-bdee7782528b_44055eb1-4b77-44d9-a6ad-516405f963b1.html,,dermal,LD50,"2,000 mg/kg bw",, "2-(isopropylthio)-3-(2,2,2-trifluoroethoxy)pyridine",256473-05-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6680fde-b1ae-42e8-a867-c2ef2357ddb4/documents/IUC5-be0e3cc4-023e-4ace-b1a2-bdee7782528b_44055eb1-4b77-44d9-a6ad-516405f963b1.html,,inhalation,LC50,5.192 mg/m3,, "2-(methylamino)ethanol, compound with sulphur dioxide",21049-70-7,The effect levels derived from the key studies were: oral LD50 (rat): 3891 mg/kg bw No acute inhalation toxicity hazard was identified (no mortality in rats exposed to a concentrated vapour atmosphere) ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68afe0ff-2f87-494c-855a-9fdf43212892/documents/IUC5-ef151c30-9870-43fa-873a-4451f4d778ee_396b7301-2b2e-45b7-90c3-29e57ef208dc.html,,,,,, "2-(methylamino)ethanol, compound with sulphur dioxide",21049-70-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68afe0ff-2f87-494c-855a-9fdf43212892/documents/IUC5-ef151c30-9870-43fa-873a-4451f4d778ee_396b7301-2b2e-45b7-90c3-29e57ef208dc.html,,oral,LD50,"3,891 mg/kg bw",adverse effect observed, 2-(methylnitroamino)ethyl nitrate,17096-47-8," Acute oral toxicity: Key study. Test method according to OECD 423, GLP study. The oral LD50 of the test item in female rats was found to be greater than 300 mg/kg bw and lower than 2000 mg/kg bw. The LD50 cut-off of the test item may be considered to be 2000 mg/kg bw. Acute dermal toxicity: Key study. Test method similar to OECD 402, GLP study. The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in rabbits. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84eee386-7e0a-4e50-9cad-9e8278ddd7b7/documents/c123c3d2-c025-4239-a996-76b33b23cf91_139490a1-d0d2-401c-8696-f04ff42c2427.html,,,,,, 2-(methylnitroamino)ethyl nitrate,17096-47-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84eee386-7e0a-4e50-9cad-9e8278ddd7b7/documents/c123c3d2-c025-4239-a996-76b33b23cf91_139490a1-d0d2-401c-8696-f04ff42c2427.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, 2-(methylnitroamino)ethyl nitrate,17096-47-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84eee386-7e0a-4e50-9cad-9e8278ddd7b7/documents/c123c3d2-c025-4239-a996-76b33b23cf91_139490a1-d0d2-401c-8696-f04ff42c2427.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-(morpholinothio)benzothiazole,102-77-2,"The repeated dose toxicity of the test substance MBS was evaluated in a chronic feeding study with Sprague-Dawley rats (Monsanto Co. 1982). Male and Female rats were treated with 0, 5, 50 or 400 mg MBS /kg bw and day. A biological relevant decrease in body weight gain and increase in absolute and/ or relative kidney weights were noted in animals of the high dose group (400 mg/kg bw/d). Based on the findings of this study a NOAEL of 50 mg/kg bw and day is suggested.The inhalation toxicity of MBS was examined in a subacute inhalation study (Monsanto Co. 1981). The study is limited concerning the recommended particle-size distribution given in current guidelines and thus an exposure of all relevant regions of the respiratory tract might not have been given. The biologically relevance of sporadic findings reported, especially systemic effects are questionable; whereas local effects noted in the inhalation study will be used as supporting evidence. Based on the fact that signs of nasal irritation observed at clinical examination were reversible, only short in duration and could not be correlated to histopathological effects, no toxicological significance was attached to this finding, and thus, no relevant local effects were observed up to 0.0102 mg/l.The dermal toxicity of the test substance MBS was evaluated in a 21-day dermal toxicity study (Monsanto Co. 1981). No test substance-related death or systemic toxicity was indicated in any of the treated animals. No compound related macroscopic lesions nor dermal irritation were noted. A few rabbits in the test group exhibited very slight to slight erythema, edema and desquamation. Similar changes of the skin were noted in treated and untreated animals, like hyperkeratosis and infiltration of inflammatory cells in the dermis (Monsanto Co. 1981). Based on the findings of this study a NOAEL of 2000 mg/kg bw and day is suggested. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e734a06b-1311-4689-a38a-439b2e11fbc2/documents/IUC5-aa4bed5a-96a6-40a8-a079-5e7b9fd66ec1_f6f8d032-db39-4225-8b06-92b955a22908.html,,,,,, 2-(morpholinothio)benzothiazole,102-77-2,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e734a06b-1311-4689-a38a-439b2e11fbc2/documents/IUC5-aa4bed5a-96a6-40a8-a079-5e7b9fd66ec1_f6f8d032-db39-4225-8b06-92b955a22908.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,, 2-(morpholinothio)benzothiazole,102-77-2,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e734a06b-1311-4689-a38a-439b2e11fbc2/documents/IUC5-aa4bed5a-96a6-40a8-a079-5e7b9fd66ec1_f6f8d032-db39-4225-8b06-92b955a22908.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",, 2-(morpholinothio)benzothiazole,102-77-2,"The acute dermal and oral toxicity of the test substance MBS is very low, indicated by LD50 values greater than 5000 mg/kg. The acute oral LD50 value in rats is greater than 7940 mg/kg (Monsanto 1973) and the dermal LD50 value in rabbits is greater than 7940 mg/kg bw (Monsanto 1973). ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e734a06b-1311-4689-a38a-439b2e11fbc2/documents/IUC5-5a7b9228-7cba-4361-a196-2b17cb7564ac_f6f8d032-db39-4225-8b06-92b955a22908.html,,,,,, 2-(morpholinothio)benzothiazole,102-77-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e734a06b-1311-4689-a38a-439b2e11fbc2/documents/IUC5-5a7b9228-7cba-4361-a196-2b17cb7564ac_f6f8d032-db39-4225-8b06-92b955a22908.html,,oral,LD50,"7,940 mg/kg bw",, 2-(morpholinothio)benzothiazole,102-77-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e734a06b-1311-4689-a38a-439b2e11fbc2/documents/IUC5-5a7b9228-7cba-4361-a196-2b17cb7564ac_f6f8d032-db39-4225-8b06-92b955a22908.html,,dermal,LD50,"7,940 mg/kg bw",, 2-(Naphthalene-2'-sulphonylamino)-benzoic acid,117309-52-1," A study was performed to assess the acute oral toxicity of2-(Naphthalene-2'-sulphonylamino)-benzoic acidin the Sprague-Dawley strain rat, following OECD guideline No. 401 of 1981. A group of ten fasted animals (five males and five females) was given a single oral dose of 2-(Naphthalene-2'-sulphonylamino)-benzoic acid as a suspension in arachis oil B.P., at a dose level of 2000 mg/kg bodyweight. There were no deaths, no signs of systemic toxicity noted during the study nor any abnormalities noted at necropsy. It was concluded that the acute oral median lethal dose (LD50) of 2-(Naphthalene-2'-sulphonylamino)-benzoic acid in the Sprague-Dawley strain rat was greater than 2000 mg/kg bodyweight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b906e54-2ab2-4d76-970d-d790a55f579b/documents/a614cdb0-d3c7-4ec9-8d01-935b54e2edbc_df4a1ab7-ec82-4ced-b30c-61ba66992e75.html,,,,,, 2-(N-ethylanilino)ethanol,92-50-2, The acute oral LD50of 2-(N-ethylanilino) ethanol in Wistar rats is > 2000 mg/kg body weight. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7568214c-427b-4dc0-861b-673faf4ec71b/documents/13ecdc6f-4545-4edb-88ff-332328a7a904_cc3cb0f8-a5e9-4d63-ae1e-ad89993a9d94.html,,,,,, 2-(N-ethylanilino)ethanol,92-50-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7568214c-427b-4dc0-861b-673faf4ec71b/documents/13ecdc6f-4545-4edb-88ff-332328a7a904_cc3cb0f8-a5e9-4d63-ae1e-ad89993a9d94.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-(octylthio)ethanol,3547-33-9,"The NOEL for systemic toxicity from a 90-day dietary toxicity study on 2-(octylthio)ethanol is 0.4% in the diet, based on decreased terminal body weights, and increased liver and kidney weights.The NOEL for systemic toxicity from a 21-day dermal toxicity study on 2-(octylthio)ethanol is at least 200 mg/kg. The NOEL for dermal irritation is 50 mg/kg. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9cc40d8d-4839-44c6-9738-26176976444a/documents/IUC5-668a7386-04e1-44bc-bce2-4e455f061a30_aa67ce72-ac32-4a36-af53-cba2a7d20c31.html,,,,,, 2-(octylthio)ethanol,3547-33-9,ACUTE ORAL toxicity LD50 value (mg/kg): >5000 ACUTE DERMAL toxicity LD50 value (mg/kg): >2000 ACUTE INHALATION toxicity 4-hour rat LC50 value (mg/L): >6.12 (aerosol) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9cc40d8d-4839-44c6-9738-26176976444a/documents/IUC5-b5744d14-1e07-4cc1-98ba-9d4be4b29734_aa67ce72-ac32-4a36-af53-cba2a7d20c31.html,,,,,, 2-(phenylmethoxy)naphthalene,613-62-7,"Two repeated dose toxicity studies for the oral route are available. The study period is 28 days and 90 days, respectively.The lowest identified NOAEL of 82 mg/kg bw/day was found for males in the sub-chronic study. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10464449-2bbd-4d94-ab12-03290edde51f/documents/IUC5-59fce168-4985-474e-b021-3b144053b39b_0eb44671-9d1e-4fc0-9746-6324daa9bdc4.html,,,,,, 2-(phenylmethoxy)naphthalene,613-62-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10464449-2bbd-4d94-ab12-03290edde51f/documents/IUC5-59fce168-4985-474e-b021-3b144053b39b_0eb44671-9d1e-4fc0-9746-6324daa9bdc4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,82 mg/kg bw/day,,rat 2-(phenylmethoxy)naphthalene,613-62-7,"For the oral and dermal route, acute toxicity studies are available. These studies were designed as limit dose studies and no toxicity was noted. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10464449-2bbd-4d94-ab12-03290edde51f/documents/IUC5-92945869-e322-4145-afc7-b4d4c29f9aa8_0eb44671-9d1e-4fc0-9746-6324daa9bdc4.html,,,,,, 2-(phenylmethoxy)naphthalene,613-62-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10464449-2bbd-4d94-ab12-03290edde51f/documents/IUC5-92945869-e322-4145-afc7-b4d4c29f9aa8_0eb44671-9d1e-4fc0-9746-6324daa9bdc4.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, 2-(phenylmethoxy)naphthalene,613-62-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10464449-2bbd-4d94-ab12-03290edde51f/documents/IUC5-92945869-e322-4145-afc7-b4d4c29f9aa8_0eb44671-9d1e-4fc0-9746-6324daa9bdc4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-(propyloxy)ethanol,2807-30-9,Only minimal hematological effects were noted in rats administered the subject chemical by gavage for 6 weeks at 195 mg/kg bw/day. Sub-chronic inhalation toxicity studies in rats indicated a clear NOAEL of 100 ppm (433 mg/m3). ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c3ae2d9-acd5-4fb1-aa3f-03876463161a/documents/IUC5-bae6c6b5-1439-425a-88f4-791dd287d1bd_e2105569-bb19-4971-82ea-603dcf135ced.html,,,,,, 2-(propyloxy)ethanol,2807-30-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c3ae2d9-acd5-4fb1-aa3f-03876463161a/documents/IUC5-bae6c6b5-1439-425a-88f4-791dd287d1bd_e2105569-bb19-4971-82ea-603dcf135ced.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,195 mg/kg bw/day,,rat 2-(propyloxy)ethanol,2807-30-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c3ae2d9-acd5-4fb1-aa3f-03876463161a/documents/IUC5-bae6c6b5-1439-425a-88f4-791dd287d1bd_e2105569-bb19-4971-82ea-603dcf135ced.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,433 mg/m3,,rat 2-(propyloxy)ethanol,2807-30-9,"In laboratory animals, the acute oral LD50 for the test substance in a key study was 3089 mg/kg bw. The acute dermal LD50 value from a key study was 1337 mg/kg bw. Acute inhalation LC50 values are in excess of 9061 mg/m3. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c3ae2d9-acd5-4fb1-aa3f-03876463161a/documents/dbef3469-77d9-4ade-bc51-cb1b82757953_e2105569-bb19-4971-82ea-603dcf135ced.html,,,,,, 2-(propyloxy)ethanol,2807-30-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c3ae2d9-acd5-4fb1-aa3f-03876463161a/documents/dbef3469-77d9-4ade-bc51-cb1b82757953_e2105569-bb19-4971-82ea-603dcf135ced.html,,oral,LD50,"3,089 mg/kg bw",no adverse effect observed, 2-(propyloxy)ethanol,2807-30-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c3ae2d9-acd5-4fb1-aa3f-03876463161a/documents/dbef3469-77d9-4ade-bc51-cb1b82757953_e2105569-bb19-4971-82ea-603dcf135ced.html,,dermal,LD50,"1,337 mg/kg bw",no adverse effect observed, 2-(propyloxy)ethanol,2807-30-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c3ae2d9-acd5-4fb1-aa3f-03876463161a/documents/dbef3469-77d9-4ade-bc51-cb1b82757953_e2105569-bb19-4971-82ea-603dcf135ced.html,,inhalation,LC50,"9,061 mg/m3",no adverse effect observed, "3,3,10,10-tetramethoxy-2,11-dioxa-3,10-disiladodecane",87135-01-1,"Three reliable repeated dose oral toxicity studies are available for 1,6-bis(trimethoxysilyl)hexane. The key study (Hita Research Laboratories, 1996) was selected on the basis of a worst-case NOAEL of 8 mg/kg bw/day. All studies reported effects in the kidneys and the urinary bladder, and in the liver and stomach. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac12d02b-024c-48ed-bd0b-4b5039c52025/documents/IUC5-0185e5c9-8d3a-440f-8aa6-ae05b5a6934c_bb1f1a31-3cde-45d9-b657-e4ffc2530d05.html,,,,,, "3,3,10,10-tetramethoxy-2,11-dioxa-3,10-disiladodecane",87135-01-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac12d02b-024c-48ed-bd0b-4b5039c52025/documents/IUC5-0185e5c9-8d3a-440f-8aa6-ae05b5a6934c_bb1f1a31-3cde-45d9-b657-e4ffc2530d05.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,8 mg/kg bw/day,,rat "3,3,10,10-tetramethoxy-2,11-dioxa-3,10-disiladodecane",87135-01-1,"A limited acute oral study conducted to GLP but without the required duration or extent of observation is supported by two good quality (guideline and GLP) repeated dose oral studies. The acute oral toxicity study (Dow Corning Corporation, 2009d) found no mortality or adverse effects in very restricted examinations 5 hours following administration of up to 2000 mg/kg bw of the test substance to rats.A good quality (guideline and GLP) acute inhalation study found the LC50 of 1,6-bis(trimethoxysilyl)hexane in the rat to be in excess of the highest vapour concentration that could be generated under the conditions of this study, 0.042 mg/l (Dow Corning Corporation, 1993). This concentration, which was nominal and based on weight measurements, was not associated with any clear treatment-related effects. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac12d02b-024c-48ed-bd0b-4b5039c52025/documents/IUC5-7b4430a3-fc78-4aa2-96b5-3b68753ea5f8_bb1f1a31-3cde-45d9-b657-e4ffc2530d05.html,,,,,, "3,3,10,10-tetramethoxy-2,11-dioxa-3,10-disiladodecane",87135-01-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac12d02b-024c-48ed-bd0b-4b5039c52025/documents/IUC5-7b4430a3-fc78-4aa2-96b5-3b68753ea5f8_bb1f1a31-3cde-45d9-b657-e4ffc2530d05.html,,oral,LD50,"1,000 mg/kg bw",no adverse effect observed, "3,3,10,10-tetramethoxy-2,11-dioxa-3,10-disiladodecane",87135-01-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac12d02b-024c-48ed-bd0b-4b5039c52025/documents/IUC5-7b4430a3-fc78-4aa2-96b5-3b68753ea5f8_bb1f1a31-3cde-45d9-b657-e4ffc2530d05.html,,inhalation,LC50,42 mg/m3,no adverse effect observed, "2,2'-(1,3-phenylene)bis(4,5-dihydro-1,3-oxazole)",34052-90-9, Repeated Dose Toxicity: Oral; NOAEL >= 30 mg/kg bw in wistar rats. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c74d0f1e-adaf-40c9-a260-8461c209f0af/documents/IUC5-95f2bb78-11b0-4d8f-ac02-efb2119559f7_c7b5e7ae-628e-4b02-a8e5-fc9bef3fe248.html,,,,,, "2,2'-(1,3-phenylene)bis(4,5-dihydro-1,3-oxazole)",34052-90-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c74d0f1e-adaf-40c9-a260-8461c209f0af/documents/IUC5-95f2bb78-11b0-4d8f-ac02-efb2119559f7_c7b5e7ae-628e-4b02-a8e5-fc9bef3fe248.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "2,2'-(1,3-phenylene)bis(4,5-dihydro-1,3-oxazole)",34052-90-9, Acute Oral Toxicity: LD50 >2000 mg/kg in wistar rats. Acute Dermal Toxicity: LD50 >2000 mg/kg in male/female wistar rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c74d0f1e-adaf-40c9-a260-8461c209f0af/documents/IUC5-4a3392fc-e39d-4a9b-9994-1e3c41d4e198_c7b5e7ae-628e-4b02-a8e5-fc9bef3fe248.html,,,,,, "2,2'-(1,3-phenylene)bis(4,5-dihydro-1,3-oxazole)",34052-90-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c74d0f1e-adaf-40c9-a260-8461c209f0af/documents/IUC5-4a3392fc-e39d-4a9b-9994-1e3c41d4e198_c7b5e7ae-628e-4b02-a8e5-fc9bef3fe248.html,,oral,LD50,"1,690 mg/kg bw",no adverse effect observed, "2,2'-(1,3-phenylene)bis(4,5-dihydro-1,3-oxazole)",34052-90-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c74d0f1e-adaf-40c9-a260-8461c209f0af/documents/IUC5-4a3392fc-e39d-4a9b-9994-1e3c41d4e198_c7b5e7ae-628e-4b02-a8e5-fc9bef3fe248.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2-(1,4-phenylene)bis((4H-3,1-benzoxazine-4-one)",18600-59-4,28-day Repeated dose toxicity oral：NOAEL is 15 mg/kg bw/day (EU method B.7) ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3984e46-705e-493b-a12a-22d739b0aa4f/documents/IUC5-bc428175-a619-471f-8aa2-e8fd1def74e9_72d6be78-e40f-4759-ae51-dcbe19fb803f.html,,,,,, "2,2-(1,4-phenylene)bis((4H-3,1-benzoxazine-4-one)",18600-59-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3984e46-705e-493b-a12a-22d739b0aa4f/documents/IUC5-bc428175-a619-471f-8aa2-e8fd1def74e9_72d6be78-e40f-4759-ae51-dcbe19fb803f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "2,2-(1,4-phenylene)bis((4H-3,1-benzoxazine-4-one)",18600-59-4,"Acute oral toxicity:LD50(rat): > 5000 mg/kg bw /day (OECD 401, limit test).Acute dermal toxicity:LD50(rabbit): >2000mg/kg bw /day (16 CFR 1500). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3984e46-705e-493b-a12a-22d739b0aa4f/documents/IUC5-28c4f169-3f5f-459e-a482-2bd5334a3920_72d6be78-e40f-4759-ae51-dcbe19fb803f.html,,,,,, "2,2-(1,4-phenylene)bis((4H-3,1-benzoxazine-4-one)",18600-59-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3984e46-705e-493b-a12a-22d739b0aa4f/documents/IUC5-28c4f169-3f5f-459e-a482-2bd5334a3920_72d6be78-e40f-4759-ae51-dcbe19fb803f.html,,oral,LD50,"5,000 mg/kg bw",, "2,2-(1,4-phenylene)bis((4H-3,1-benzoxazine-4-one)",18600-59-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3984e46-705e-493b-a12a-22d739b0aa4f/documents/IUC5-28c4f169-3f5f-459e-a482-2bd5334a3920_72d6be78-e40f-4759-ae51-dcbe19fb803f.html,,dermal,LD50,"2,000 mg/kg bw",, "2,2'-(1,4-phenylene)bis[4-[(4-methoxyphenyl)methylene]oxazol-5(4H)-one]",51202-86-9,In an oral study in rats the LD50 was above 5000 mg/kg bw. There were no adverse effects at this dose. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/112943f9-9d98-404f-bdef-84a67c2b2eba/documents/IUC5-da421759-ec19-4e82-ac59-ef211a6d4fe6_5be86d6e-373d-4443-9d36-3f0243866c6a.html,,,,,, "2,2'-(1,4-phenylene)bis[4-[(4-methoxyphenyl)methylene]oxazol-5(4H)-one]",51202-86-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/112943f9-9d98-404f-bdef-84a67c2b2eba/documents/IUC5-da421759-ec19-4e82-ac59-ef211a6d4fe6_5be86d6e-373d-4443-9d36-3f0243866c6a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,2'-(2-methylpropylidene)bis[4,6-xylenol]",33145-10-7, Repeated dose toxicity: oral 28-day NOAEL: 10 mg/kg/day (based on clinical signs and behavioural changes observed in the functional observations tests). ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/99be1a59-98be-410d-9be2-071425de9bec/documents/c9c1a30b-fcf7-4ff9-85e8-0f5510224b2b_8be29ed7-0b97-41a7-bd5c-7039511cfca4.html,,,,,, "2,2'-(2-methylpropylidene)bis[4,6-xylenol]",33145-10-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/99be1a59-98be-410d-9be2-071425de9bec/documents/c9c1a30b-fcf7-4ff9-85e8-0f5510224b2b_8be29ed7-0b97-41a7-bd5c-7039511cfca4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "2,2'-(2-methylpropylidene)bis[4,6-xylenol]",33145-10-7," Acute Toxicity via Oral Route Key value determined in a GLP accredited laboratory study using the Acute Toxic Class Method, performed in accordance with OECD Guideline 423, EU Method B.1 tris and US EPA Procedure OPPTS 870.1100. The oral LD50 value of Lowinox® 22IB46 in Wistar rats was established to be within the range of 300-2000 mg/kg body weight.  According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 500 mg/kg body weight. Acute Toxicity via Dermal Route Key value determined in a GLP accredited laboratory study using the standard acute method in rats, performed in accordance with OECD Guideline 402, EU Method B.3 and US EPA Procedure OPPTS 870.1200. The dermal LD50 value of Lowinox® 22IB46 in Wistar rats was established to exceed 2000 mg/kg body weight.   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99be1a59-98be-410d-9be2-071425de9bec/documents/b96f530a-15b8-4b68-a314-2563aece97d6_8be29ed7-0b97-41a7-bd5c-7039511cfca4.html,,,,,, "2,2'-(2-methylpropylidene)bis[4,6-xylenol]",33145-10-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99be1a59-98be-410d-9be2-071425de9bec/documents/b96f530a-15b8-4b68-a314-2563aece97d6_8be29ed7-0b97-41a7-bd5c-7039511cfca4.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "2,2'-(2-methylpropylidene)bis[4,6-xylenol]",33145-10-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99be1a59-98be-410d-9be2-071425de9bec/documents/b96f530a-15b8-4b68-a314-2563aece97d6_8be29ed7-0b97-41a7-bd5c-7039511cfca4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2'-(C16-18 (evennumbered) alkyl imino) diethanol",1218787-30-4,"For the evaluation for repeated dose toxicity by 2,2’-(C16-18 (even numbered) alkyl imino) diethanol ('HT-PFAEO'), read-across is applied. There are two 90 day oral toxicity studies for 2,2’-(C16-18 (even numbered, C18 unsaturated) alkyl imino) diethanol ('Tallow-PFAEO'). There is a 90 day dietary study in rats and a 90 Day study in dogs where the test substance was added to the diet in a solution in maize oil.  The Dog study was dosed at 13, 40, 120 mg/kg/day with a maize oil vehicle control.  The rats were feed diets containing 170, 500, 1’500 and 4’500ppm of the tests substance.  Both studies provide NOAEL values.  These studies were carried out in 1965, but are sufficiently well documented including information on the test substance to be considered suitable for use for REACH. Due to issues with sporadic vomiting and anorexia in the dog study, the data from the rat study is most relevant for evaluation of the 90 day NOAEL. In a recent 28-day study (OECD 422) study due to the treatment-related mortality that occurred in four males and in three females administered 175 mg/kg/day, caused by intestinal lesions, this dose level was considered to exceed the maximum tolerated dose. The local gastro-intestinal effects were less severe than in the prematurely terminated animals, and at  75 mg/kg/day were not considered adverse since there was no effect on the clinical condition of these animals. The lowest 90-day NOAEL comes from the read-across from Oleyl-PFAEO and represents the an addtional complete study. The value is lower than the NOAEL from the old 90-day study on Tallow-PFAEO. However, when information is combined with read-across to long-term studies with similar PFAEO substance, all show a consistent pattern of local effects driving the NOAEL. This value of 30 mg/kg bw is therefore a conservative starting point for NOAEL for systemic toxicity.   A study OECD 422 on HT-PFAEO substance itself has been performed which confirrms that indeed a worse-case approach has been undertaken with regards to read-across to a suitable 90-day study. The OECD 422 resulted in NOAEL of 30 mg/kg/day due to bodyweight loss seen in male rats in the study. The target organ does not change from that of the 90-day studies on similar substances and is still the GI tract. There was no indication during the study that extending the exposure period would have resulted in a lower NOAEL. Thus given this evidence the read-across approach is considered valid.     Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The lowest 90-day NOAEL comes from the read-across from Oleyl-PFAEO and represents the most recent and complete study. The value is lower than the NOAEL from the old 90-day study on Tallow-PFAEO. However, when information is combined with read-across to long-term studies with similar PFAEO substance, all show a consistent pattern of local effects driving the NOAEL. This value of 30 mg/kg bw is therefore a conservative starting point for NOAEL for systemic toxicity. A study (OECD 422) is planned to be performed on the HT-PFAEO substance itself in order to confirm acceptability of this approach. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e1bdbde-e630-4796-8eb2-df0c079dceae/documents/IUC5-6266a5bc-7948-44b3-ae6d-76f964f6932d_18797879-e3c4-4e8c-970f-706c3b41ffaf.html,,,,,, "2,2'-(C16-18 (evennumbered) alkyl imino) diethanol",1218787-30-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e1bdbde-e630-4796-8eb2-df0c079dceae/documents/IUC5-6266a5bc-7948-44b3-ae6d-76f964f6932d_18797879-e3c4-4e8c-970f-706c3b41ffaf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "2,2'-(C16-18 (evennumbered) alkyl imino) diethanol",1218787-30-4,"The only available study is the oral LD50 study which shows LD50 to be >2000 mg/kg.  As 2,2’-(C16-18 (evennumbered), alkyl imino) diethanol is a skin irritant but not corrosive, dermal absorption would be expected to be lower than oral, so the LD50 would also be expected to be > 2000mg/kg.  There is no study for an inhalation LC50, but the physical form of the substance as a waxy solid at ambient temperatures and its low vapour pressure mean that an inhalation LC50 study is not scientifically justified as inhalation exposure is not anticipated. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e1bdbde-e630-4796-8eb2-df0c079dceae/documents/IUC5-7cc7e300-c03e-4c52-89a9-f50fd81f954a_18797879-e3c4-4e8c-970f-706c3b41ffaf.html,,,,,, "2,2'-(cyclohexylimino)bisethanol",4500-29-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Available data allows for route-to-route extrapolation. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Available data allows for expert judgement concerning this endpoint. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Available data allows for route-to-route extrapolation. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): Available data allows for expert judgement concerning this endpoint. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline study according to GLP available. No derivations and/or confounders. Klimisch rating 1 representing reliability without restrictions. Information valid and meets data requirements with regard to hazard identification and classification. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff64ceb1-e52b-418f-8727-add8564483a8/documents/IUC5-29c229b4-442d-4a3d-86f4-a80dff2e9a0a_218345b5-2ff0-40bd-905f-cbe069a35fc5.html,,,,,, "2,2'-(cyclohexylimino)bisethanol",4500-29-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff64ceb1-e52b-418f-8727-add8564483a8/documents/IUC5-29c229b4-442d-4a3d-86f4-a80dff2e9a0a_218345b5-2ff0-40bd-905f-cbe069a35fc5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat "2,2'-(cyclohexylimino)bisethanol",4500-29-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Guideline study according to GLP available. No derivations and/or confounders. Klimisch rating 1 representing reliability without restrictions. Information valid and meets data requirements. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff64ceb1-e52b-418f-8727-add8564483a8/documents/IUC5-831a139c-2e49-49ca-b5e3-bb0385037070_218345b5-2ff0-40bd-905f-cbe069a35fc5.html,,,,,, "2,2'-(cyclohexylimino)bisethanol",4500-29-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff64ceb1-e52b-418f-8727-add8564483a8/documents/IUC5-831a139c-2e49-49ca-b5e3-bb0385037070_218345b5-2ff0-40bd-905f-cbe069a35fc5.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "2,2'-(piperazine-1,4-diyl)bis(ethanesulphonic) acid",5625-37-6,"In a GLP study according to OECD TG 423 (acute toxic class method) with rats the LD 50 value of the test substance was determined as > 2000 mg/kg bw (reference 7.2.1-1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The only available study is of high quality and reliable without restrictions. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/743dd794-98e6-436b-bf87-dd9ccc2f9d1a/documents/9ec87c40-951f-4533-b591-47f32d8a4c30_f239ed6a-cb14-472e-bbfe-3ecd6082dc9d.html,,,,,, "2,2'-(piperazine-1,4-diyl)bis(ethanesulphonic) acid",5625-37-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/743dd794-98e6-436b-bf87-dd9ccc2f9d1a/documents/9ec87c40-951f-4533-b591-47f32d8a4c30_f239ed6a-cb14-472e-bbfe-3ecd6082dc9d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2'-(p-phenylenediethene-2,1-diyl)bisbenzonitrile",13001-39-3, Acute oral toxicity in rats: LD50 > 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfcad869-96fa-4345-9f85-d1b9daae1957/documents/3a119644-90a2-4e79-8c66-14ee47dc9595_bbad271d-4b02-439e-9d68-e46e2b5bf48e.html,,,,,, "2,2'-(vinylenedi-p-phenylene)bis[5-methylbenzoxazole]",2397-00-4, Oral LD50 (male and female) > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71142846-c7f8-4360-b4dd-0adfbb464b3f/documents/1fb0dee8-6305-4ad6-8774-e48fbcb628ef_365b6008-0bcf-4798-8ae5-7f0fba9c1351.html,,,,,, "2,2'-(vinylenedi-p-phenylene)bis[5-methylbenzoxazole]",2397-00-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71142846-c7f8-4360-b4dd-0adfbb464b3f/documents/1fb0dee8-6305-4ad6-8774-e48fbcb628ef_365b6008-0bcf-4798-8ae5-7f0fba9c1351.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2,2',2'-tetrakis(hydroxymethyl)-3,3'-oxydipropan-1-ol",126-58-9,"The NOAEL for oral toxicity in rats was 1500 mg/kg bw/d in a 14 day range-finding study and 1000 mg/kg bw/d in a combined repeated dose/reproductive toxicity study. Low toxicity is also predicted for the inhalation and dermal routes of exposure.A 90days repeated dose toxicity study (OECD 408) in Crl:CD(SD) rats is still ongoing. The key value for CSA will be updated after the OECD 408 final report completed.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A 14-day range-finding study and an OECD 422 screening study are available for Di-Penta. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77a7718d-8061-415f-b785-37a01c1b4f18/documents/10c375e4-4273-4ab8-9d49-b1f14c0071f0_c372c14f-aed5-403b-b78a-9d5aecf02f31.html,,,,,, "2,2,2',2'-tetrakis(hydroxymethyl)-3,3'-oxydipropan-1-ol",126-58-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77a7718d-8061-415f-b785-37a01c1b4f18/documents/10c375e4-4273-4ab8-9d49-b1f14c0071f0_c372c14f-aed5-403b-b78a-9d5aecf02f31.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2,2',2'-tetrakis(hydroxymethyl)-3,3'-oxydipropan-1-ol",126-58-9,"The acute oral LD50 of the substance in the rat is >2000 mg/kg bw. The acute 4-hour inhalation LC50 of the substance in the rat is >5.07 mg/L. No data is available for acute dermal toxicity, however very low toxicity can be predicted. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77a7718d-8061-415f-b785-37a01c1b4f18/documents/cf70ba6a-3177-464c-a522-f2fd657b1610_c372c14f-aed5-403b-b78a-9d5aecf02f31.html,,,,,, "2,2,2',2'-tetrakis(hydroxymethyl)-3,3'-oxydipropan-1-ol",126-58-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77a7718d-8061-415f-b785-37a01c1b4f18/documents/cf70ba6a-3177-464c-a522-f2fd657b1610_c372c14f-aed5-403b-b78a-9d5aecf02f31.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,2,2',2'-tetrakis(hydroxymethyl)-3,3'-oxydipropan-1-ol",126-58-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77a7718d-8061-415f-b785-37a01c1b4f18/documents/cf70ba6a-3177-464c-a522-f2fd657b1610_c372c14f-aed5-403b-b78a-9d5aecf02f31.html,,inhalation,LC50,> 5.07 mg/L,no adverse effect observed, "2,2',2''-nitrilotriethanol citrate",29340-81-6," Results for repeated dose toxicity were based on the LD50 of TEA (CAS no. 102-71-6), one of the two dissociation products of the substance (CAS no. 29340-81-6). In a sub-chronic oral toxicity study, a NOAEL of 1000 mg/kg bw/day was established for TEA, the highest dose tested. In a sub-acute inhalation toxicity study with rats, a NOAEC for systemic effects of 0.5 mg/L was established for TEA, the highest dose tested. 0.02 mg/L (the lowest dose tested) was considered to be the NOAEC for local effects in females. Since slight local effects were observed in males, this concentration was determined to be the LOAEC for local effects in males. In a sub-chronic dermal toxicity study, NOAEL's of 125 and 250 mg/kg bw/day were established for local effects for males and females. Systemic NOAEL's of 125 and 500 mg/kg bw/day were determined for males and females, respectively, based on kidney effects. Similar effects were observed in a sub-chronic dermal study in mice, performed according to the same protocol. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e32659f-69ca-4d5f-a7fc-f86867ce4655/documents/5d34b3b6-b69f-4466-99a8-6082646b5e9c_7a2e80d4-bc34-4e05-bf12-e586a74c6edd.html,,,,,, "2,2',2''-nitrilotriethanol citrate",29340-81-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e32659f-69ca-4d5f-a7fc-f86867ce4655/documents/5d34b3b6-b69f-4466-99a8-6082646b5e9c_7a2e80d4-bc34-4e05-bf12-e586a74c6edd.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,500 mg/m3,,rat "2,2',2''-nitrilotriethanol citrate",29340-81-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e32659f-69ca-4d5f-a7fc-f86867ce4655/documents/5d34b3b6-b69f-4466-99a8-6082646b5e9c_7a2e80d4-bc34-4e05-bf12-e586a74c6edd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2',2''-nitrilotriethanol citrate",29340-81-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e32659f-69ca-4d5f-a7fc-f86867ce4655/documents/5d34b3b6-b69f-4466-99a8-6082646b5e9c_7a2e80d4-bc34-4e05-bf12-e586a74c6edd.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,125 mg/kg bw/day,,rat "2,2',2''-nitrilotriethanol citrate",29340-81-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e32659f-69ca-4d5f-a7fc-f86867ce4655/documents/5d34b3b6-b69f-4466-99a8-6082646b5e9c_7a2e80d4-bc34-4e05-bf12-e586a74c6edd.html,Repeated dose toxicity – local effects,inhalation,LOAEC,20 mg/m3,adverse effect observed,rat "2,2',2''-nitrilotriethanol citrate",29340-81-6," For the substance (CAS no. 29340-81-6), the LD50 for acute oral toxicity was determined to be > 5000 mg/kg bw. Results for dermal acute toxicity were based on the LD50 of the two dissociation product (TEA, CAS no. 102 -71 -6) of the substance, which was determined to be > 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e32659f-69ca-4d5f-a7fc-f86867ce4655/documents/d7826242-f47f-4208-986e-8e2fc5f3d1e0_7a2e80d4-bc34-4e05-bf12-e586a74c6edd.html,,,,,, "2,2',2''-nitrilotriethanol citrate",29340-81-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e32659f-69ca-4d5f-a7fc-f86867ce4655/documents/d7826242-f47f-4208-986e-8e2fc5f3d1e0_7a2e80d4-bc34-4e05-bf12-e586a74c6edd.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2,2',2''-nitrilotriethanol citrate",29340-81-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e32659f-69ca-4d5f-a7fc-f86867ce4655/documents/d7826242-f47f-4208-986e-8e2fc5f3d1e0_7a2e80d4-bc34-4e05-bf12-e586a74c6edd.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,2',2''-Nitrilotriethanol, propoxylated",37208-53-0,"NOAEL (28 days repeated dose, Wistar): ≥ 1000 mg/kg bw. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb9f09fd-33a5-4c51-bf6e-87457d19092e/documents/IUC5-1d7e5261-ee6b-484e-bced-f13ed39a10e8_3dcbaf27-c763-4c1b-8391-d3d1a85ec05c.html,,,,,, "2,2',2''-Nitrilotriethanol, propoxylated",37208-53-0,"LD50 (oral) > 2500 mg/kg bw (2000 mg/kg tested, no effects observed). LD50 (dermal) > 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb9f09fd-33a5-4c51-bf6e-87457d19092e/documents/IUC5-17989e89-2840-47bc-b789-2d687f7b3460_3dcbaf27-c763-4c1b-8391-d3d1a85ec05c.html,,,,,, "2,2,2-trifluoro-1-(trifluoromethyl)ethyl methacrylate",3063-94-3, One key study is available for the end point acute oral toxicity. The study was performed according to OECD guideline 423 and under the conditions of GLP. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02524d0c-ecae-4e87-b523-8cf1456290b5/documents/41f59a8c-34ac-4374-b01f-6e0fc2e3f6e7_85c3498f-c81a-4ee3-8fe0-b95c89082210.html,,,,,, "2,2,2-trifluoroethanol",75-89-8," Repeated dose toxicity by oral exposure : no data available Repeated dose toxicity by dermal exposure : no data available Repeated dose toxicity by inhalation: On reliable key study is available as described below. In a 28-day repeated inhalation toxicity study (Tosoh, 2000) performed according to the OECD Guideline No. 412 and in compliance with GLP, 2,2,2 Trifluoroethanol (TFE) (purity 100%) was administered to male and female rats. TFE was dispensed in vapor form and a whole body method exposure was used. The analytical concentrations of vapors of TFE in the inhalation chamber during exposure were 1.14 (low-dose group); 5.26 (medium-dose (1) group); 14.9 (medium-dose (2) group) and 51.1 ppm (high-dose group) corresponding to 4.7; 22; 62 and 213 mg/m3 respectively. These concentrations were chosen in accordance to the results of a previous 14-day repeated inhalation toxicity study. The exposure was performed 6h/day, 7days/week for 4 weeks. An air control group was set up as the no treatment control group. Furthermore, 2 and 7-week recovery groups were added. The 2-week group consisted of a male and female air control group, a medium-dose (2) group, and a high-dose group. The 7-week group consisted of male air control group, a medium-dose (2) group and a high-dose group. The 7‑week recovery study involved only males and its main objective was to observe the recovery in male reproductivre organs. Animals were observed every day for the presence of any clinical signs, and they were weighed at different time point during the exposure period and also during the recovery periods (2 or 7 weeks). In parallel the food consumption was also quantified during the exposure and the recovery periods. At the end of the exposure period or at the end of the recovery periods, animals were sacrificed and several parameters were analyzed such as hematology, clinical chemistry, urinanalysis, gross pathology (including organ weight), and histopathology. At the highest concentration (213 mg/m3), several measured parameters were changed in comparison to the air control animals. Indeed, the animals presented a decrease in body weight and a change in the blood chemistry. Furthermore, at the highest concentration, TFE is highly toxic to male reproductive system since a decrease in testis and epididymis weights were observed during the exposure period and this decrease was maintained during the recovery period. This decrease of the reproductive organ weight was accompanied by a severe loss of germ cells such as spermatocytes , spermatids and spermatozoa while the seminiferous tubules contained only Sertoli cells. At the middle concentration of 62 mg/m3, adverse effects were observed as a decrease of the thymus weight in the treated female rats and change in hematological parameters in both sexes suggesting an anemia reaction following TFE repeated dose exposure by inhalation. Based on these results, the main effects due to 2,2,2 Trifluoroethanol were observed in the spermiogenesis inhibition of male reproductive organs and in the hematological changes that suggested hypochromic anemia. The Lowest Observed Adverse Effect Concentration (LOAEC) is considered to be 51.1 ppm (approximately 213 mg/m3) based on the decrease in the mean corpuscular volume and the decrease in the mean corpuscular hemoglobin in the hematological analysis which were irreversible during the two-week recovery period. Moreover toxicity to the reproduction as spermiogenesis alteration was also observed at this concentration. At the middle level (14.9 ppm corresponding to 62 mg/m3), only hematological effects were observed which were reversible during the 2 -week recovery period . Hence the 62 mg/m3 exposure was considered as the No Observed Adverse Effect concentration (NOAEC) while the No Observed Effect Concentration (NOEC) was assumed to be 5.26 ppm (approximately 22 mg/m3) regarding the absence of any effects after 28-day repeated exposure. This study is considered as acceptable as it satisfied the criteria of the OECD Guideline No. 412. The effects on the male reproductive system observed after a repeated exposure by inhalation were already considered and taken into account in the self-classification for the toxicity to the reproduction (see § 7.8). Regarding the hematological effects observed in the animal exposed by inhalation, they can be considered as relevant to human health following repeated exposure by inhalation. It is recognised that these effects which may be seen in humans are considered of minimal toxicological importance and do not justify classification (see Guidance on the application of the CLP criteria, § 3.9.2.5.2). However, considering the irreversibility of these effects during the two-week recovery period of the study, a classification is proposed as STOT-RE2 (H373) according to the CLP. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/27d9f9a3-1028-4901-b161-844044b94c57/documents/IUC5-ce60d1f9-0bc0-4aaf-addd-64249f3b61c9_98b05a57-5f86-4ad1-a47e-c75f01eea412.html,,,,,, "2,2,2-trifluoroethanol",75-89-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/27d9f9a3-1028-4901-b161-844044b94c57/documents/IUC5-ce60d1f9-0bc0-4aaf-addd-64249f3b61c9_98b05a57-5f86-4ad1-a47e-c75f01eea412.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,62 mg/m3,,rat "2,2,2-trifluoroethanol",75-89-8,"Acute toxicity: Oral: LD50 male: 153 mg/kg (K, Reliability 1)Acute toxicity: Dermal: LD50 combined: > 2000 mg/kg bw (K, Reliability 1)Acute toxicity: Inhalation: LD50 combined: 3.25 mg/L (K, Reliability 2) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27d9f9a3-1028-4901-b161-844044b94c57/documents/IUC5-712b3330-58c3-4db2-b999-c1bbb8464e3b_98b05a57-5f86-4ad1-a47e-c75f01eea412.html,,,,,, "2,2,2-trifluoroethanol",75-89-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27d9f9a3-1028-4901-b161-844044b94c57/documents/IUC5-712b3330-58c3-4db2-b999-c1bbb8464e3b_98b05a57-5f86-4ad1-a47e-c75f01eea412.html,,oral,LD50,153 mg/kg bw,adverse effect observed, "2,2,2-trifluoroethanol",75-89-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27d9f9a3-1028-4901-b161-844044b94c57/documents/IUC5-712b3330-58c3-4db2-b999-c1bbb8464e3b_98b05a57-5f86-4ad1-a47e-c75f01eea412.html,,inhalation,LC50,"3,250 mg/m3",adverse effect observed, "2,2,3,3,4,4,5,5,6,6,7,7-dodecafluoroheptan-1-ol",335-99-9," LD50 oral, rat: > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/412e6ca5-ad9a-4e1a-ac72-683f0120b3b5/documents/6d2eb4ea-55c7-46ab-b4a5-0b7325350c0b_e156e104-fc51-4587-94a7-199cb04c3809.html,,,,,, "2,2,3,3,4,4,5,5,6,6,7,7-dodecafluoroheptan-1-ol",335-99-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/412e6ca5-ad9a-4e1a-ac72-683f0120b3b5/documents/6d2eb4ea-55c7-46ab-b4a5-0b7325350c0b_e156e104-fc51-4587-94a7-199cb04c3809.html,,oral,LD50,"2,390 mg/kg bw",no adverse effect observed, "2,2,3,3,4,4,5,5,6,6-decafluoro-6-trifluorovinyloxyhexanenitrile",120903-40-4, The acute toxicity of MV5CN was evaluated in a single study in rats. The result of the study was: Rat oral LD50 > 2000 mg/kg when tested according to OECD 423. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acb7e047-bb41-4ccc-8097-95334ea7daf3/documents/16639791-e6e8-4455-83e9-f6f1978261fa_dabb3d43-af40-48d8-acfc-ae4dbcebed0c.html,,,,,, "2,2,3,3,5,5,6,6-octafluoro-4-(trifluoromethyl)morpholine",382-28-5,"Two repeat dose studies have been conducted on perfluoro–N-methylmorpholine. A 28 day oral study and a 90 day inhalation study have been conducted on perfluoro-N-methylmopholine. Additionally, four repeat dose studies have been conducted on Fluoroinert Category Members. A 28 Day Oral study has been conducted on perfluoroisopropylmorpholine, a 90 Day Inhalation study has been conducted on perfluorohexane, a 28 day oral study was conducted on perfluorohexane and a 28 Day Inhalation study was conducted on perfluorotributylamine. NOAEL in the 28 day oral study on perfluoro-N-methylmorpholine is 2000 mg/kg/day.NOAEL in the 90 day inhalation study on perfluoro-N-methylmorpholine is 49589 ppm.Tests on other Fluoroinert Category membersNOAEL in the 28 day oral study on perfluoroisoproplymorpholine is 1000 mg/kg/dayNOAEL for the 90 Day Inhalation study on perfluorohexane study is 49821 ppmNOAEL in the 28 Day Inhalation study on perfluorotributylamine was 7.28 ml/m3 (single dose tested, which represents saturation) NOAEL in the 28 Day Oral study on perfluorohexane was >2000 mg/kgThese results are considered applicable to perfluoro-N-methylmorpholine. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/28edcc8f-7a9b-42fa-a9b3-d0babb3ff1f3/documents/IUC5-663a2a2e-ae3a-4614-ad97-e48ba0bca802_8ecd28e5-db00-470e-a4f5-410dc06cb98f.html,,,,,, "2,2,3,3,5,5,6,6-octafluoro-4-(trifluoromethyl)morpholine",382-28-5,"An acute oral toxicity study has been conducted on Perfluoro-N-methylmorpholine, an acute oral study has been conducted on Fluorinert Category member perfluorotripropylamine, an acute inhalation toxicity study and an acute oral toxicity study have been conducted on Fluoroinert Category member FC-770, an acute oral study was conducted on Fluoroinert Category member perfluorohexane, an acute oral study was conducted on Fluoroinert Category member perfluoroheptane and five acute studies have been conducted on Fluoroinert Category member perfluorotributylamine. Classification for category members is based on experimental results for certain members of the class. Since one of the defining characteristics of the class is a lack of biological effects based on chemical and electronic properties, the results from tests (mammalian toxicity, environmental and ecotoxicity) are applicable to all members of the category. Perfluoro-N-methylmorpholine results:Oral LD50>5000 mg/kgPerfluorotripropylamine results:Oral LD50>5000 mg/kg FC-770 results:Inhalation 4 hour LC50>20 mg/lAcute Oral LD50>5000 mg/kgPerfluorohexane resultOral LD50>5 g/kgPerfluoroheptane resultOral LD50>5000 mg/kgPerfluorotributylamine results:Oral LD50> 5000 mg/kgOral LD50>10000 mg/kgInhalation LC50>41 mg/l Inhalation LC50>17 mg/lIP LD50>34.6 g/kgThe studies on Fluoroinert Category members are considered to be applicable to perfluoro-N-methylmorpholine. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28edcc8f-7a9b-42fa-a9b3-d0babb3ff1f3/documents/IUC5-1476aa30-25c8-496b-8893-534ede3d824b_8ecd28e5-db00-470e-a4f5-410dc06cb98f.html,,,,,, "2,2,3-trimethylbutane",464-06-2,Acute toxicity oral LD50 >5000 mg/kg bw in rats (OECD TG 401) Acute toxicity dermal LD50 >2000 mg/kg bw in rabbits   Acute toxicity inhalation LC50 >33520 mg/m³ in rats (OECD TG 403) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e922eed1-a8a5-4494-abe7-4be600a4c3ce/documents/33828701-e78e-4739-a866-1630058943b8_cd6e309e-a6c2-4b83-b6ff-48ee674f41ba.html,,,,,, "2,2,3-trimethylbutane",464-06-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e922eed1-a8a5-4494-abe7-4be600a4c3ce/documents/33828701-e78e-4739-a866-1630058943b8_cd6e309e-a6c2-4b83-b6ff-48ee674f41ba.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "2,2,3-trimethylbutane",464-06-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e922eed1-a8a5-4494-abe7-4be600a4c3ce/documents/33828701-e78e-4739-a866-1630058943b8_cd6e309e-a6c2-4b83-b6ff-48ee674f41ba.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,2,3-trimethylbutane",464-06-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e922eed1-a8a5-4494-abe7-4be600a4c3ce/documents/33828701-e78e-4739-a866-1630058943b8_cd6e309e-a6c2-4b83-b6ff-48ee674f41ba.html,,inhalation,LC50,"> 33,520 mg/m3",adverse effect observed, "2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine",25513-64-8,"In a subchronic oral gavage study male and female Wistar rats were administered 0, 10, 60 and 180 mg 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine/kg bw /day in a 3 month investigation (IBR 1988). In the 60 mg/kg bw/day group increased mean liver weights were seen in female rats. Therefore, under the experimental conditions of this study the ""No-Observed Adverse Effect-Level"" (NOAEL) of 2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine is considered to be 10 mg/kg bw/day and the ""Lowest- Observed Adverse Effect-Level"" (LOAEL) 60 mg/kg bw/day for male and female rats. No repeated-dose toxicity tests are available for the dermal and inhalative route of exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b9a43fd-4ce7-4577-af8c-4b87afb3aafd/documents/IUC5-4b1f1fad-8468-41d5-9886-264590256ab0_9852e1e7-e736-4a09-b5c2-b99a0c47048e.html,,,,,, "2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine",25513-64-8,"2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine is of moderate oral acute toxicity with an oral LD50(rat) of 910 mg/kg bw ( Klimmer, 1965). According to REACH Annex VIII, 8.5. column 2, acute dermal and inhalative toxicity studies do not need to be conducted if the substance is classified as corrosive to the skin. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b9a43fd-4ce7-4577-af8c-4b87afb3aafd/documents/IUC5-d275c210-2009-4485-a48c-260912421b2f_9852e1e7-e736-4a09-b5c2-b99a0c47048e.html,,,,,, "2,2,4(or 2,4,4)-trimethylhexane-1,6-diamine",25513-64-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b9a43fd-4ce7-4577-af8c-4b87afb3aafd/documents/IUC5-d275c210-2009-4485-a48c-260912421b2f_9852e1e7-e736-4a09-b5c2-b99a0c47048e.html,,oral,LD50,910 mg/kg bw,, "2,2,4,4,6,6-hexamethylcyclotrisilazane",1009-93-4," In the key acute oral toxicity study in mice, conducted according to a protocol similar to OECD TG 401, but not in compliance with GLP, the LD50 value for the test substance, 2,2,4,4,6,6-hexamethylcyclotrisilazane, was concluded to be 1700 mg/kg bw (Rhône-Poulenc, 1973). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2808c950-fc3e-4cfd-b9e4-75a79a684f2f/documents/53748038-2890-47e0-8aff-6c92a3a16758_aaf4405a-5486-4636-9dd7-833c194c853f.html,,,,,, "2,2,4,4,6,6-hexamethylcyclotrisilazane",1009-93-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2808c950-fc3e-4cfd-b9e4-75a79a684f2f/documents/53748038-2890-47e0-8aff-6c92a3a16758_aaf4405a-5486-4636-9dd7-833c194c853f.html,,oral,LD50,"1,700 mg/kg bw",adverse effect observed, "2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]-henicosan-21-one",64338-16-5, Based on the changes observed in the available 13 week oral toxicity study (OECD 408) performed in Sprague Dawley rats the NOAEL was considered to be 225 mg/kg bw/d in males and 75 mg/kg bw/d in females (highest doses tested) ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b8bea510-3886-4e95-b3b5-03b79b4e6401/documents/0a71dbfa-f53b-4a88-acb2-61912a0dd5d8_f1d58a72-4d1a-46e6-963e-c0420edc2e41.html,,,,,, "2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]-henicosan-21-one",64338-16-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b8bea510-3886-4e95-b3b5-03b79b4e6401/documents/0a71dbfa-f53b-4a88-acb2-61912a0dd5d8_f1d58a72-4d1a-46e6-963e-c0420edc2e41.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat "2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]-henicosan-21-one",64338-16-5," Acute toxicity after single oral application was tested in female rats, which received up to 5000 mg/kg bw (groups of ten females). The LD50value for acute oral toxicity is 2800 mg/kg bw. Gross pathology revealed darkly reddened/spotted lungs and liver in prematurely died animals. No changes were observed in surviving females.   A 4 h dust exposure of the test substance to 12 rats (6 males and 6 females) at concentrations of 444, 1006, 1228, 3005 or 8569 mg/m3led to a LC50was determined to be 1670 mg/m3(corresponding to 1.67 mg/L). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8bea510-3886-4e95-b3b5-03b79b4e6401/documents/d9d880bd-3362-4085-b67f-1a4e4696a7d3_f1d58a72-4d1a-46e6-963e-c0420edc2e41.html,,,,,, "2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]-henicosan-21-one",64338-16-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8bea510-3886-4e95-b3b5-03b79b4e6401/documents/d9d880bd-3362-4085-b67f-1a4e4696a7d3_f1d58a72-4d1a-46e6-963e-c0420edc2e41.html,,oral,LD50,"2,800 mg/kg bw",adverse effect observed, "2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]-henicosan-21-one",64338-16-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8bea510-3886-4e95-b3b5-03b79b4e6401/documents/d9d880bd-3362-4085-b67f-1a4e4696a7d3_f1d58a72-4d1a-46e6-963e-c0420edc2e41.html,,inhalation,LC50,1.67 mg/m3,adverse effect observed, "2,2,4,4-tetramethyl-7-oxa-3,20-diazadispiro[5.1.11.2]henicosan-21-one hydrochloride",73833-37-1,Acute Oral Toxicity: LD50 > 2000 mg/kg bw for female rats.No data available for acute dermal toxicity and acute inhalation toxicity. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cdb4943-b9bb-4c19-8178-b940caecbb6b/documents/IUC5-fcfffebf-c2fa-4c9d-94d1-f9fb34d17af0_1e231c0c-5d52-4d73-8960-58b6cec41bac.html,,,,,, "2,2,4,4-tetramethylcyclobutane-1,3-diol, mixed isomers",3010-96-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e47a2ef2-3848-4538-9a24-16445e0731f5/documents/457f6559-b4fa-424d-b3ff-ec276cf9123f_01228015-0d6c-445e-8988-c2a3b3a77947.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "2,2,4,4-tetramethylcyclobutane-1,3-diol, mixed isomers",3010-96-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e47a2ef2-3848-4538-9a24-16445e0731f5/documents/35f85195-4351-4004-882a-7fc8724ec0f7_01228015-0d6c-445e-8988-c2a3b3a77947.html,,oral,LD50,"1,500 mg/kg bw",, "2,2,4,4-tetramethylcyclobutane-1,3-diol, mixed isomers",3010-96-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e47a2ef2-3848-4538-9a24-16445e0731f5/documents/35f85195-4351-4004-882a-7fc8724ec0f7_01228015-0d6c-445e-8988-c2a3b3a77947.html,,dermal,LD50,"2,000 mg/kg bw",, "2,2,4-trimethyl-1-oxa-4-aza-2-silacyclohexane",10196-49-3," No valid information on repeated oral, dermal or inhalation toxicity is available. The invalid studies have the following outcome: - Repeated dose toxicity-oral: 30 male Wistar rats were exposed to increasing doses of the test substance on 5 consecutive days, observed parameter: Mortality; cumulative LD50 = 868 mg/kg bw. - Repeated dose toxicity-inhalation: 10 male Wistar rats were exposed to 2.475 mg test substance/L air for 4h on 5 days per week for a total exposure time of 4 weeks; LC50 > 2.475 mg/L, no adverse effects observed up to highest concentration. - Repeated dose-dermal: no study available ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5eb85033-256f-4f67-a175-fdb5b128e4a5/documents/a243b371-8d88-4906-b34f-d39ee6461efe_a9b9802f-5156-429c-bbff-5504bf546925.html,,,,,, "2,2,4-trimethyl-1-oxa-4-aza-2-silacyclohexane",10196-49-3," 2,2,4-trimethyl-1-oxa-4-aza-2-silacyclohexane is classified as corrosive, therefore no acute studies by oral, by inhalation or by dermal route are necessary based on Annex VII/VIII of Regulation (EU) 1907/2006 column 2. However, non-guideline studies for acute oral, inhalation and dermal toxicity reported in the year 1969 are available. -Acute oral toxicity, female/male Wistar rats, oral gavage, doses: 50, 100,250, 500, 1000, 1500, 1750,2000, 2100,2400, 2500 mg/kg bw (males); 250,500, 1000, 1300, 1500,2000, 2250 and 2500 mg kg bw (females); non-guideline study similar to Standard acute method, non-GLP: LD50 (males) = 1890 mg kg bw and LD50 (females) = 1645 mg/kg bw. - Acute toxicity: Inhalation, female/male Wistar rats, two tests with aerosols/spray mist, hole body exposure, test 1: 0.064, 0.296, 0.662 mg/L (analysed concentrations, males) 1 x 4 hrs., 0,82 mg/L (analysed concentrations, females) 1 x 4 hours; 0,141, 0.9 mg/L (analysed doses, males) 4 x 4 hrs. test 2: 0.344 g/L; Clinical signs were observed at the highest dose in test 1 ; LC0 males >0.662 mg/L, females >0.820 mg/L (1 x 4 hrs.); LC0 males >0.9 mg/L (5 x 4 hrs.); non-guideline study, non GLP, cannot be used for Classification due to methodological deficiencies. LC0males - Acute toxicity: Inhalation, male Wistar rats/male mice, male guinea pigs, cat and rabbit, exposure to substance vapour ((12.18), 12.35, 48.4, 51.4 mg test substance/L air), 4h, observation 14 days, LC50 (rats) > 48.4 <51.4 mg/L, LC50 (mice) > 12.35 <48.4 mg/L, non-guideline study, non-GLP, used for Classification due to sufficient documented results and generally accepted method. -Acute toxicity: dermal, male rats, non-guideline study similar to Standard acute method, non-GLP: LD50 (males) > 1000 µl/kg bw (900 mg/kg bw). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5eb85033-256f-4f67-a175-fdb5b128e4a5/documents/6b2142f8-100e-4889-b4cc-410ce6f9d0c1_a9b9802f-5156-429c-bbff-5504bf546925.html,,,,,, "2,2,4-trimethyl-1-oxa-4-aza-2-silacyclohexane",10196-49-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5eb85033-256f-4f67-a175-fdb5b128e4a5/documents/6b2142f8-100e-4889-b4cc-410ce6f9d0c1_a9b9802f-5156-429c-bbff-5504bf546925.html,,oral,LD50,"1,645 mg/kg bw",adverse effect observed, "2,2,4-trimethyl-1-oxa-4-aza-2-silacyclohexane",10196-49-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5eb85033-256f-4f67-a175-fdb5b128e4a5/documents/6b2142f8-100e-4889-b4cc-410ce6f9d0c1_a9b9802f-5156-429c-bbff-5504bf546925.html,,inhalation,LC50,"12,350 mg/m3",adverse effect observed, "2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol",79-94-7,Three studies are available for the repeated dose oral toxicity endpoint:Repeated dose toxicity: oral.001 (28 day) - NOAEL (rat) = 1000 ppm in dietRepeated dose toxicity: oral.002 (90 day) - NOAEL (rat) = 1000 mg/kg bw/dayRepeated dose toxicity: oral.003 (90 day) - NOAEL (rat) >100 mg/kgOne study is available for the repeated dose dermal toxicity endpoint:Repeated dose toxicity: dermal.001 (21 day) - NOAEL (rabbit): 2500 mg/kg bw/day3-month oral toxicity studies in mice and in rats were added to the updated dossier (215). These studies are preliminary to the 2-year carcinogenicity studies performed by NTP (NTO TR 587) and were considered supportive data. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9ef8da1-f83b-494e-927a-b2e835930c91/documents/e7e9f0af-0a45-4999-8da4-24e8d7417477_2e214763-7cb6-42e9-a841-0903210e6ec5.html,,,,,, "2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol",79-94-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9ef8da1-f83b-494e-927a-b2e835930c91/documents/e7e9f0af-0a45-4999-8da4-24e8d7417477_2e214763-7cb6-42e9-a841-0903210e6ec5.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,500 mg/kg bw/day",,rabbit "2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol",79-94-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9ef8da1-f83b-494e-927a-b2e835930c91/documents/e7e9f0af-0a45-4999-8da4-24e8d7417477_2e214763-7cb6-42e9-a841-0903210e6ec5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol",79-94-7,Six studies are available for the acute oral toxicity endpoint:Acute toxicity: oral.001 - LD50 (male mouse): >7000 mg/kg bwAcute toxicity: oral.002 - LD50 (mouse): >10000 mg/kg bwAcute toxicity: oral.003 - LD50 (rat): >5000 mg/kg bwAcute toxicity: oral.004 - LD50 (rat): >50 mg/kg bwAcute toxicity: oral.005 - LD50 (male rat): >10000 mg/kg bwAcute toxicity: oral.006 - LD50 (rat): >50000 mg/kg bwTwo studies are available for the acute inhalation toxicity endpoint:Acute toxicity: inhalation.001 - 1h-LC50 (rat): > 57 mg/L airAcute toxicity: inhalation.002 - 8h-LC50 (rat)> 0.5 mg/L air - 8h-LC50 (mouse)> 0.5 mg/L air - 8h-LC50 (guinea pig)> 0.5 mg/L airThree studies are available for the acute dermal toxicity endpoint:Acute toxicity: dermal.001 - LD50 (rabbit): >2 g/kg bwAcute toxicity: dermal.002 - LD50 (rabbit)> 10 g/kg bwAcute toxicity: dermal.003 - LD50 (rabbit): >200 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9ef8da1-f83b-494e-927a-b2e835930c91/documents/9b345598-9b18-48a9-9641-624a5706f4f5_2e214763-7cb6-42e9-a841-0903210e6ec5.html,,,,,, "2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol",79-94-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9ef8da1-f83b-494e-927a-b2e835930c91/documents/9b345598-9b18-48a9-9641-624a5706f4f5_2e214763-7cb6-42e9-a841-0903210e6ec5.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol",79-94-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9ef8da1-f83b-494e-927a-b2e835930c91/documents/9b345598-9b18-48a9-9641-624a5706f4f5_2e214763-7cb6-42e9-a841-0903210e6ec5.html,,dermal,LD50,"10,000 mg/kg bw",no adverse effect observed, "2,2',6,6'-tetrabromo-4,4'-isopropylidenediphenol",79-94-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9ef8da1-f83b-494e-927a-b2e835930c91/documents/9b345598-9b18-48a9-9641-624a5706f4f5_2e214763-7cb6-42e9-a841-0903210e6ec5.html,,inhalation,LC50,"57,000 mg/m3",no adverse effect observed, "2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane",40039-93-8,The 28 day repeated days study performed on rats reported an adverse systemic effect (increasing body weight) at a concentration of 1000 mg/kg bw/day for males. Therefore the NOAEL is 300mg/kg bw/day. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a50e357-88b4-4745-820e-29b9a3fe3fe8/documents/47453807-27bf-40ac-87cf-552d5597d9f1_f941b693-963e-4ac7-93e8-5ef3669828dc.html,,,,,, "2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane",40039-93-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a50e357-88b4-4745-820e-29b9a3fe3fe8/documents/47453807-27bf-40ac-87cf-552d5597d9f1_f941b693-963e-4ac7-93e8-5ef3669828dc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane",40039-93-8,Acute oral toxicity was assessed in the rat using the Acute Toxic Class Method. The oral LD50 value of F-2200HM in Wistar rats was established to exceed 2000mg/kg body weight. Acute inhalation toxicity was waived as inhalation is unlikely due to the low vapour pressure of F-2200HM. Acute dermal toxicity was assessed in the rat. The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000mg/kg bodyweight. No deaths occured in the dermal and oral acute studies. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a50e357-88b4-4745-820e-29b9a3fe3fe8/documents/37635e4f-0648-4186-b4d4-9c1af9c780ae_f941b693-963e-4ac7-93e8-5ef3669828dc.html,,,,,, "2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane",40039-93-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a50e357-88b4-4745-820e-29b9a3fe3fe8/documents/37635e4f-0648-4186-b4d4-9c1af9c780ae_f941b693-963e-4ac7-93e8-5ef3669828dc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane",40039-93-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a50e357-88b4-4745-820e-29b9a3fe3fe8/documents/37635e4f-0648-4186-b4d4-9c1af9c780ae_f941b693-963e-4ac7-93e8-5ef3669828dc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane and 2,4,6-tribromophenol",158725-44-1," F-3014 was administered orally by gavage for a period of twenty-eight consecutive days at dose levels of 30, 300 and 1000 mg/kg bw/day, followed by a recovery period of 14 days. resulted in treatmentrelated Changes in the liver, thyroid and pituitary glands were recorded and were considered not to represent an adverse health effect; therefore a ‘No Observed Adverse Effect Level’ (NOAEL) was established at 1000 mg/kg bw/day. other routes are considered not relevant and were not tested. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0d4c096-5d4b-4840-a38e-1e1efa591c8e/documents/IUC5-9e6ea270-5249-428b-b39f-ac7a281be687_3f5f37dd-9e0a-4273-8914-1fffff11016b.html,,,,,, "2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane and 2,4,6-tribromophenol",158725-44-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0d4c096-5d4b-4840-a38e-1e1efa591c8e/documents/IUC5-9e6ea270-5249-428b-b39f-ac7a281be687_3f5f37dd-9e0a-4273-8914-1fffff11016b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 ",, "2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane and 2,4,6-tribromophenol",158725-44-1," Acute oral: LD 50 > 5000 mg/kg bw. No deaths,no signs of systemic toxicity,all animals gained weight during the study. Acute inhalation: Waiver is suggested based onthe substancehigh molecular weight size and low water solubility Acute dermal: LD50>2000 mg/kg bw, no deaths, no signs of systemic toxicity, all animals gained weight during the study. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0d4c096-5d4b-4840-a38e-1e1efa591c8e/documents/IUC5-0ae07957-f7bf-4e88-be3c-457eab53fc2c_3f5f37dd-9e0a-4273-8914-1fffff11016b.html,,,,,, "2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane and 2,4,6-tribromophenol",158725-44-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0d4c096-5d4b-4840-a38e-1e1efa591c8e/documents/IUC5-0ae07957-f7bf-4e88-be3c-457eab53fc2c_3f5f37dd-9e0a-4273-8914-1fffff11016b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,2',6,6'-Tetrabromo-4,4'-isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane and 2,4,6-tribromophenol",158725-44-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0d4c096-5d4b-4840-a38e-1e1efa591c8e/documents/IUC5-0ae07957-f7bf-4e88-be3c-457eab53fc2c_3f5f37dd-9e0a-4273-8914-1fffff11016b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2,6,6-tetramethyl-4-oxopiperidinooxy",2896-70-0," A guideline 28-day repeat dose study on the test substance 2,2,6,6-tetramethyl-4-oxopiperidinooxy, administered by the oral route. The dose range tested was 15, 150, 1000 mg/kg with the NOEL set at 150 mg/kg. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9dbc8a03-035c-43e8-a795-e03b1cca0c31/documents/IUC5-7479a2d0-deaf-4381-a6d2-1f4523f600c0_7cfd0c03-53d6-4ec8-a04c-4f19f4b2b3f6.html,,,,,, "2,2,6,6-tetramethyl-4-oxopiperidinooxy",2896-70-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9dbc8a03-035c-43e8-a795-e03b1cca0c31/documents/IUC5-7479a2d0-deaf-4381-a6d2-1f4523f600c0_7cfd0c03-53d6-4ec8-a04c-4f19f4b2b3f6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "2,2,6,6-tetramethyl-4-oxopiperidinooxy",2896-70-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9dbc8a03-035c-43e8-a795-e03b1cca0c31/documents/IUC5-7f81098a-f416-485f-afdf-3f7b5dfc94a0_7cfd0c03-53d6-4ec8-a04c-4f19f4b2b3f6.html,,oral,LD50,"1,464 mg/kg bw",adverse effect observed, "2,2,6,6-tetramethyl-4-oxopiperidinooxy",2896-70-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9dbc8a03-035c-43e8-a795-e03b1cca0c31/documents/IUC5-7f81098a-f416-485f-afdf-3f7b5dfc94a0_7cfd0c03-53d6-4ec8-a04c-4f19f4b2b3f6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2,6,6-tetramethylpiperidin-4-ol",2403-88-5,"oral: NOEL < 60 mg/kg/day (GLP-OECD Guideline study, MHW, 1998) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a81993ab-2c3f-479e-b78f-8c273062648a/documents/deefa379-5a34-4537-ad0d-5052da75e4c3_9d8f4b67-89f7-4957-8db8-b0ccbc7aae41.html,,,,,, "2,2,6,6-tetramethylpiperidin-4-ol",2403-88-5,"oral: LD50 (female) = 1564 mg/kg bw (GLP-OECD Study, MHW, 1998) LD50 (male) = 1482 mg/kg bw (GLP-OECD Study, MHW, 1998) LD 50 (female) = 2104 mg/kg bw (OECD Study, CIBA, 1983) LD50 (male) = 2729 mg/kg bw (OECD Study, CIBA, 1983) LD50 (male/female) > 2000 mg/kg (OECD Study, Evonik, 1993)Dermal: LD50 > 2000 mg/kg bw (GLP, OECD Study, CIBA, 1992) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a81993ab-2c3f-479e-b78f-8c273062648a/documents/349378a3-d6db-4012-aef2-594a74e9b84c_9d8f4b67-89f7-4957-8db8-b0ccbc7aae41.html,,,,,, "2,2,6,6-tetramethylpiperidin-4-ol",2403-88-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a81993ab-2c3f-479e-b78f-8c273062648a/documents/349378a3-d6db-4012-aef2-594a74e9b84c_9d8f4b67-89f7-4957-8db8-b0ccbc7aae41.html,,dermal,LD50,"> 2,000 mg/kg bw",adverse effect observed, "2,2,6,6-Tetramethylpiperidin-4-yl dodecanoate",101238-01-1,"The substance is tolerated better by feed dosing than by gavage application. This is most likely due to the highly irritating properties resulting in more severe local effects that have a more pronounced effect upon gavage dosing. In the 90-day feeding study, local inflammation of the caecum was observed at the highest dose group of 10000 ppm for males and females and body weight was affected for males only. The NOAEL for 90-day feed exposure was identified as 2500 ppm (ca 170 - 193 mg/kg bw). ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/81e7d712-c8bb-47bb-aba2-93d5f06efa54/documents/IUC5-dbc15f17-c1cb-4246-b6e5-47ff123a511f_0f31a745-9676-4fd9-8142-972177edf483.html,,,,,, "2,2,6,6-Tetramethylpiperidin-4-yl dodecanoate",101238-01-1,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/81e7d712-c8bb-47bb-aba2-93d5f06efa54/documents/IUC5-dbc15f17-c1cb-4246-b6e5-47ff123a511f_0f31a745-9676-4fd9-8142-972177edf483.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,170 mg/kg bw/day,,rat "2,2,6,6-Tetramethylpiperidin-4-yl dodecanoate",101238-01-1,"Acute Toxicity:- oral: 2/6 rats died at 2000 mg/kg bw (BASF SE, 10A0731/11X589, 2013)- dermal: LD50 > 2000 mg/kg bw (rat, BASF SE, 11A0731/11X590, 2013) ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81e7d712-c8bb-47bb-aba2-93d5f06efa54/documents/IUC5-6b107b3c-d475-48eb-973a-964a4b27121d_0f31a745-9676-4fd9-8142-972177edf483.html,,,,,, "2,2,6,6-Tetramethylpiperidin-4-yl dodecanoate",101238-01-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81e7d712-c8bb-47bb-aba2-93d5f06efa54/documents/IUC5-6b107b3c-d475-48eb-973a-964a4b27121d_0f31a745-9676-4fd9-8142-972177edf483.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, "2,2,6,6-Tetramethylpiperidin-4-yl dodecanoate",101238-01-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81e7d712-c8bb-47bb-aba2-93d5f06efa54/documents/IUC5-6b107b3c-d475-48eb-973a-964a4b27121d_0f31a745-9676-4fd9-8142-972177edf483.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,2,6,6-tetramethylpiperidinooxy",2564-83-2," According to REACH Regulation (EC) No. 1907/2006, the test substance 2,2,6,6-tetramethylpiperidinooxy (TEMPO) does not need to be tested for acute toxicity as the substance is classified as corrosive to the skin. Therefore, an acute oral toxicity study is not available, however, in order to fulfill TSCA 8e requirements the substance was tested earlier for acute dermal and inhalation toxicity. The acute inhalation toxicity study was considered to be invalid and was disregarded for classification due to major methodological deficiencies. The study was set up as limit study, but the results revealed an LC100 below the test concentration (nominal test concentration of 4.5 mg/L), and no further doses were tested in order to characterize the toxic concentration range. Moreover, the test material condensed on the surfaces of the delivery apparatus and inhalation chamber during delivery, so that the actual test concentration is unknown. It was estimated that the rats were exposed to vapor concentrations at least 10-fold less than the nominal concentration. Since the test item is corrosive to the skin, corrosion to the respiratory tract might have contributed to the lethal effect and hampered the investigation of inhalation toxicity. Due to the corrosive nature of the test substance, risk management measures to avoid inhalation exposure (technical measures and use of personal protective equipment) are in place. The mean acute dermal lethal dose (LD50) of 2,2,6,6-tetramethylpiperidinooxy was found to be lower than 2000 mg/kg bw in male and female rabbits in a limit test. A full test was not performed. Since the test item was shown to be corrosive to the skin and the estimated cause for mortality in this study were severe corrosive effects, the study is considered to be invalid for the estimation of dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f55f547-525c-4cd5-95a9-123cf5947045/documents/7a5b54fd-0b45-49cb-b396-9c34720ced59_81052e1d-427f-461d-97e5-00ab4e1faea4.html,,,,,, "2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol",118-82-1,"The data base consists of oral studies in rats and dogs of 28 day, 90 day and 2 year duration, together with two unreliable studies in monkeys. Although the chronic studies are relatively old they are well reported and allow a weight of evidence based conclusion on the repeated dose toxicity. However when evaluating the NOAEL levels it is important to consider that the animals suffered from infections and the effects observed consisted of an aggravation of effects also seen in the concurrent control animals. Therefore they are considered rather conservative. The main target organ after subchronic and chronic exposure was the liver in both rat and dog. The effects were observed at comparable dose levels in both species, suggesting that the interspecies differences are low. The 2 year study in dogs included a 7 month recovery period in which most of the effects were reversible at least down to levels that were not considered to impair the function of the liver. The two monkey studies are both old and show no significant toxicological effects in the animals over the test period. Overall, the studies show that no severe organ toxicity was observed and the lowest NOAEL that is used for the assessment of 4 mg/kg w/day in the 2-year rat study is considered conservative. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17a981ee-78f5-43ea-8e1f-d9cee0505e5c/documents/IUC5-889eca50-ff0b-4a69-9abe-bbf0a9f6e9e1_d4244fc6-a48c-46b6-917f-72ef88c8061c.html,,,,,, "2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol",118-82-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17a981ee-78f5-43ea-8e1f-d9cee0505e5c/documents/IUC5-889eca50-ff0b-4a69-9abe-bbf0a9f6e9e1_d4244fc6-a48c-46b6-917f-72ef88c8061c.html,Chronic toxicity – systemic effects,oral,NOAEL,4 mg/kg bw/day,,rat "2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol",118-82-1,Key study: Acute oral: Experimental results: Equivalent to OECD 401. GLP study. LD50 > 2000 mg/kg bwKey study: Acute dermal: Experimental results: Equivalent to OECD 402. GLP study. LD50 > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17a981ee-78f5-43ea-8e1f-d9cee0505e5c/documents/IUC5-4b451947-a55c-43af-a289-fbd9447ae5b9_d4244fc6-a48c-46b6-917f-72ef88c8061c.html,,,,,, "2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol",118-82-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17a981ee-78f5-43ea-8e1f-d9cee0505e5c/documents/IUC5-4b451947-a55c-43af-a289-fbd9447ae5b9_d4244fc6-a48c-46b6-917f-72ef88c8061c.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,2',6,6'-tetra-tert-butyl-4,4'-methylenediphenol",118-82-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17a981ee-78f5-43ea-8e1f-d9cee0505e5c/documents/IUC5-4b451947-a55c-43af-a289-fbd9447ae5b9_d4244fc6-a48c-46b6-917f-72ef88c8061c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,2'-[(1-methylethylidene)bis(cyclohexane-4,1-diyloxymethylene)]bisoxirane",13410-58-7,"In a combined repeated dose and reproductive/ developmental toxicity test, the No-Observed-Adverse-Effect Level (NOAEL) for repeated dose toxicity was estimated to be 62.5 mg/kg based on occurrence of death, decreased body weight, effects on calcium metabolism and injury of the kidney occurring at 1 000 mg/kg and hepatic effects, effects on bone/lipid metabolism, injury of stomach and cecum and reaction to anaemia occurring at 250 mg/kg and above. A guideline study is available to address the REACH endpoint. The study was conducted under GLP conditions and is assigned a reliability score of 1 in accordance with the criteria set forth by Klimisch et al. (1997). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/344e1a03-50e5-461a-83b3-50f4b539e2f7/documents/47abd09c-adc4-4149-91e4-8c6a747fafb8_79583b6a-004e-4389-a7a3-c466039189e7.html,,,,,, "2,2'-[(1-methylethylidene)bis(cyclohexane-4,1-diyloxymethylene)]bisoxirane",13410-58-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/344e1a03-50e5-461a-83b3-50f4b539e2f7/documents/47abd09c-adc4-4149-91e4-8c6a747fafb8_79583b6a-004e-4389-a7a3-c466039189e7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,62.5 mg/kg bw/day,,rat "2,2'-[(1-methylethylidene)bis(cyclohexane-4,1-diyloxymethylene)]bisoxirane",13410-58-7,"Oral (Gamer, 2005) Under the conditions of the study, the median lethal dose of the test material after oral administration was found to be greater than 2 000 mg/kg bw in rats.     Inhalation (Waiver) The study does not need to be conducted because exposure of human via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size – (exposure considerations).     Dermal (Waiver) The study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation) – study scientifically not necessary / other information available). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/344e1a03-50e5-461a-83b3-50f4b539e2f7/documents/9fd433eb-3bbd-4e25-a993-bf65f5492284_79583b6a-004e-4389-a7a3-c466039189e7.html,,,,,, "2,2'-[(1-methylethylidene)bis(cyclohexane-4,1-diyloxymethylene)]bisoxirane",13410-58-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/344e1a03-50e5-461a-83b3-50f4b539e2f7/documents/9fd433eb-3bbd-4e25-a993-bf65f5492284_79583b6a-004e-4389-a7a3-c466039189e7.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,2'-[(1-methylethylidene)bis[(2,6-dibromo-4,1-phenylene)oxymethylene]]bisoxirane",3072-84-2,The 28 day repeated days study performed on rats reported an adverse systemic effect (increasing body weight) at a concentration of 1000 mg/kg bw/day for males. Therefore the NOAEL is 300mg/kg bw/day. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6292f932-98a5-4b40-9271-dc6c1e0ed2a9/documents/474ac005-75ad-46a4-9a38-91d9f22f812f_00dc65f8-1e1d-4a56-85f5-24e947242933.html,,,,,, "2,2'-[(1-methylethylidene)bis[(2,6-dibromo-4,1-phenylene)oxymethylene]]bisoxirane",3072-84-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6292f932-98a5-4b40-9271-dc6c1e0ed2a9/documents/474ac005-75ad-46a4-9a38-91d9f22f812f_00dc65f8-1e1d-4a56-85f5-24e947242933.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2,2'-[(1-methylethylidene)bis[(2,6-dibromo-4,1-phenylene)oxymethylene]]bisoxirane",3072-84-2, Acute oral toxicity (rat): LD50 > 2000mg/kg body weight. No deaths occured. Acute dermal toxicity (rat): LD50> 2000mg/kg bodyweight. No deaths occured. Acute inhalation toxicity: waiver based on PSD. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6292f932-98a5-4b40-9271-dc6c1e0ed2a9/documents/70a28e23-8a22-4da2-af45-74cda340b91a_00dc65f8-1e1d-4a56-85f5-24e947242933.html,,,,,, "2,2'-[(1-methylethylidene)bis[(2,6-dibromo-4,1-phenylene)oxymethylene]]bisoxirane",3072-84-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6292f932-98a5-4b40-9271-dc6c1e0ed2a9/documents/70a28e23-8a22-4da2-af45-74cda340b91a_00dc65f8-1e1d-4a56-85f5-24e947242933.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2'-[(1-methylethylidene)bis[(2,6-dibromo-4,1-phenylene)oxymethylene]]bisoxirane",3072-84-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6292f932-98a5-4b40-9271-dc6c1e0ed2a9/documents/70a28e23-8a22-4da2-af45-74cda340b91a_00dc65f8-1e1d-4a56-85f5-24e947242933.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methoxyphenyl)-3-oxobutyramide]",4531-49-1," A combined repeated dose toxicity study with reproduction/developmental toxicity screening testwith the test item administered by oral gavage in Wistar rats (10/sex/dose) was performed according to OECD TG 422. Oral dosing of male and fernale Wistar rats (10 per sex and group) with the test item at dose levels of 50, 200 or 1000 mg/kg b.w./day for at least 28 days, revealed no treatment-related findings onparental animals, on fertility, on embryo-foetal development, or on pup development.From the results presented in this report a definitive No Observed Adverse Effect Level(NOAEL) for parental and reproduction/developmental toxicity for the test item of 1000 mg/kg/day was established. Sprague Dawley rats (50 per sex per dose) were exposed to 1000, 3000, 9000 ppm test item in diet (corresponding to 62, 186, 555 mg/kg bw/day and 64, 194, 579 mg/kg bw/day in male and female rats, respectively) for 104 weeks. The test item did neither induce toxicity nor tumorigenicity. The NOAEL in this study was 9000 ppm in diet. Subacute toxicity of the test item was investigated in an 21 days aerosol inhalation study in rats, which were exposed to 0, 54, 157, 410 mg/m3 test item (6 h/d, 5 d/w). The bodyweights of the male and female rats of the highest treatment group were slightly decreased during the exposure period when compared with those of the control and other treated groups. In the treated rats from all concentration level groups yellowish or yellow discoloration of the lungs was seen at autopsy. Slight but significant increase of both absolute and relative weights of the lungs was noted in rats from the top concentration group. Histopathology revealed in the lungs of these rats pneumoconiosis showing numerous brown-yellow, birefringent particles about 2 - 4 um in diameter in the lumen of numerous alveoli, in small bronchi, in numerous histiocytes in the interstitium and in peribronchial lymphatic tissue, associated with focal accumulation of foamy pneumocytes in the alveoli and focal lymphohistiocytic infiltration. After a recovery period of 21 days, to which a further group of rats exposed to the 410 mg/m3concentration of the tested compound was subjected, practically no regression of the pulmonal changes was observed. In treated rats from the 157 mg/m3and 54 mg/m3concentration groups focal accumulation of minute brown-yellow, birefringent particles was observed in the cytoplasm of histiocytic elements in the interstitium, in occasional alveoli, in the lumen of a few small bronchi and very occasionally also in the peribronchial lymphatic tissue, however without obvious accumulation of foamy cells in the alveoli and without inflammatory infiltration. Other minor microscopical findings obtained in some treated and control animals were only incidental in nature and not related to the inhalation of the test item. It can be inferred from the observations made during the above study that the ""no observable effect level"" for rats is below 54 mg/m3air. The effects observed at the mid and low test concentration were only due to the deposition of the test material but did not cause adverse effects like inflammation etc. Therefore, the mid test concentration of 157 mg/m3 can be regarded as ""no observable adverse effect level"". ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da7db67b-f1e4-4a69-996e-44b83a5720a7/documents/59b68af6-52ce-4db2-aa47-11b30df9947f_662996c4-8676-4073-8569-1d4ab6fe3082.html,,,,,, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methoxyphenyl)-3-oxobutyramide]",4531-49-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da7db67b-f1e4-4a69-996e-44b83a5720a7/documents/59b68af6-52ce-4db2-aa47-11b30df9947f_662996c4-8676-4073-8569-1d4ab6fe3082.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methoxyphenyl)-3-oxobutyramide]",4531-49-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da7db67b-f1e4-4a69-996e-44b83a5720a7/documents/59b68af6-52ce-4db2-aa47-11b30df9947f_662996c4-8676-4073-8569-1d4ab6fe3082.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,230 mg/m3,,rat "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methoxyphenyl)-3-oxobutyramide]",4531-49-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da7db67b-f1e4-4a69-996e-44b83a5720a7/documents/59b68af6-52ce-4db2-aa47-11b30df9947f_662996c4-8676-4073-8569-1d4ab6fe3082.html,Repeated dose toxicity – local effects,inhalation,NOAEC,230 mg/m3,no adverse effect observed,rat "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methoxyphenyl)-3-oxobutyramide]",4531-49-1," Female rats were subjected to test acute oral toxicity. The test substance was administered by gavage at the highest applicable dose of 15000 mg/kg bw. Three animals died at this dose within 4 hours after application showing no signs of toxicity. The other animals survived the 14 day observation period. At the end of the observation period there were no changes found in necropsy in all animals. Due to this findings the oral LD50 value is > 15000 mg/kg bw. Acute inhalation toxicity of the test item has been investigated in male and female Wistar rats. They were exposed to 230 mg test substance per cubic meter for 4 h (maximal applicable dose). All animals survived the 14 day observation period. No macroscopic visible changes were observed at necropsy at the end of the observation period, resulting in a LC50 value of > 230 mg/m³ for the inhalation of dust. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da7db67b-f1e4-4a69-996e-44b83a5720a7/documents/0ae46fad-4247-4b6e-bafd-d7c8386dd6c8_662996c4-8676-4073-8569-1d4ab6fe3082.html,,,,,, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methoxyphenyl)-3-oxobutyramide]",4531-49-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da7db67b-f1e4-4a69-996e-44b83a5720a7/documents/0ae46fad-4247-4b6e-bafd-d7c8386dd6c8_662996c4-8676-4073-8569-1d4ab6fe3082.html,,oral,LD50,"> 15,000 mg/kg bw",no adverse effect observed, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methoxyphenyl)-3-oxobutyramide]",4531-49-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da7db67b-f1e4-4a69-996e-44b83a5720a7/documents/0ae46fad-4247-4b6e-bafd-d7c8386dd6c8_662996c4-8676-4073-8569-1d4ab6fe3082.html,,inhalation,LC0,> 230 mg/m3,no adverse effect observed, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxobutyramide]",5468-75-7,"In oral studies (short term as well as chronic) with the close analogue substance (PY12) no adverse effects were detected up to the limit dose or the highest dose tested. In a short term repeated dose inhalation study with another close analogue substance (PY13) no adverse effects were found. No study with dermal application is available Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7782ea8d-6969-43da-8aa8-34ccfd4f1fd6/documents/cdd76ab0-7dfb-4a67-be63-1f14cceb5f19_43523198-f8fc-431f-b936-85802cf7e89c.html,,,,,, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxobutyramide]",5468-75-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7782ea8d-6969-43da-8aa8-34ccfd4f1fd6/documents/cdd76ab0-7dfb-4a67-be63-1f14cceb5f19_43523198-f8fc-431f-b936-85802cf7e89c.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,52 mg/m3,,rat "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxobutyramide]",5468-75-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7782ea8d-6969-43da-8aa8-34ccfd4f1fd6/documents/cdd76ab0-7dfb-4a67-be63-1f14cceb5f19_43523198-f8fc-431f-b936-85802cf7e89c.html,Chronic toxicity – systemic effects,oral,NOAEL,555 mg/kg bw/day,,rat "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxobutyramide]",5468-75-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7782ea8d-6969-43da-8aa8-34ccfd4f1fd6/documents/cdd76ab0-7dfb-4a67-be63-1f14cceb5f19_43523198-f8fc-431f-b936-85802cf7e89c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,52 mg/m3,no adverse effect observed, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxobutyramide]",5468-75-7," Male and female Tif. RAI rats were subjected to test acute oral toxicity. The test substance was administered by gavage at dose levels up to the highest applicable dose of 10000 mg/kg bw. No animal died under these conditions, thus leading to a LD50 > 10000 mg/kg bw. No substance related gross organ changes were seen at necropsy. Acute inhalation toxicity of the test item has been investigated in male and female Tif: RAIf (SPF) rats (10 per sex). They were exposed to 4250 mg test substance per cubic meter for 4 h (maximal applicable dose). All animals survived the 14 day observation period. No macroscopic visible changes were observed at necropsy at the end of the observation period, resulting in a LC50 value of > 4250 mg/m³ (4.25 mg/L) for the inhalation of aerosol. Acute dermal toxicity of the test item was tested in male and female Sprague-Dawley rats. The maximal applicable dose (3 g test item /kg bw suspended in polyethylene glycol:water 50:50 - final volume 9.9 ml; corresponding to 1710 mg/kg bw) were applied to the skin. No clinical signs were observed and no animals died during the 7 day observation period, resulting in a LD50 > 3000 mg/kg bw (corresponding to > 1710 mg/kg bw). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7782ea8d-6969-43da-8aa8-34ccfd4f1fd6/documents/82256e84-e081-4e07-8621-b595b0007585_43523198-f8fc-431f-b936-85802cf7e89c.html,,,,,, "2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[N-(2-methylphenyl)-3-oxobutyramide]",5468-75-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7782ea8d-6969-43da-8aa8-34ccfd4f1fd6/documents/82256e84-e081-4e07-8621-b595b0007585_43523198-f8fc-431f-b936-85802cf7e89c.html,,oral,LD0,"> 2,000 mg/kg bw",no adverse effect observed, "2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]",6505-28-8,"In a subacute repeated dose oral toxicity study with Sprague-Dawley rats a NOEL of >= 1000 mg/kg for the test substance was observed (MHLW 10-1630, 2000). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14048ad7-6d00-4903-9ef6-a7f604446fc4/documents/1df58511-7d8b-4812-94ea-36f2e3795048_741bcf3c-4f80-49e7-a5c9-e7be62a53ee1.html,,,,,, "2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]",6505-28-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14048ad7-6d00-4903-9ef6-a7f604446fc4/documents/1df58511-7d8b-4812-94ea-36f2e3795048_741bcf3c-4f80-49e7-a5c9-e7be62a53ee1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]",6505-28-8," An oral LD50 of greater than 2000 mg/kg bw was determined and no mortality was observed in an acute oral toxicity study in rats (GLP, OECD 423, 2000). A dermal LD50 of greater than 2000 mg/kg bw was determined and no mortality was observed in an acute dermal toxicity study with rats (GLP, OECD 402, 2012). No mortality was observed after a 4h-exposure (including a 14 -day recovery period) to a dust aerosol (4250 mg/m3) of a related pigment (similar to OECD 403, performed in 1978). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14048ad7-6d00-4903-9ef6-a7f604446fc4/documents/182db8b3-390c-4159-b97e-4d8f7f6479ab_741bcf3c-4f80-49e7-a5c9-e7be62a53ee1.html,,,,,, "2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]",6505-28-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14048ad7-6d00-4903-9ef6-a7f604446fc4/documents/182db8b3-390c-4159-b97e-4d8f7f6479ab_741bcf3c-4f80-49e7-a5c9-e7be62a53ee1.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]",6505-28-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14048ad7-6d00-4903-9ef6-a7f604446fc4/documents/182db8b3-390c-4159-b97e-4d8f7f6479ab_741bcf3c-4f80-49e7-a5c9-e7be62a53ee1.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,2'-[(3,3'-dimethoxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-N-phenylbutyramide]",6505-28-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14048ad7-6d00-4903-9ef6-a7f604446fc4/documents/182db8b3-390c-4159-b97e-4d8f7f6479ab_741bcf3c-4f80-49e7-a5c9-e7be62a53ee1.html,,inhalation,discriminating conc.,"4,250 mg/m3",no adverse effect observed, "2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol]",67990-27-6," Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol] / C.I. Solvent Yellow 107 (67990-27-6).The studies are as mentioned below: 1.In a acute oral toxicity study,rats were treated with test chemical in the concentration of 5000 mg/kg bw orally. No mortality observed in treated rats at 5000 mg/kg bw. Therefore,LD50 was considered to be > 5000 mg/kg bw,when rats were treated with test chemical orally. 2.Acute oral toxicity study was done in rats using test material Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate] (5160-02-1).No mortality was observed at dose 10000 mg/kg bw in treated rats.Hence,LD50 value was considered to be >10000 mg/kg bw,when rats were treated with Barium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate] (5160-02-1)orally. 3.Acute oral toxicity study was performed in rats using test chemical.No mortality was observed at dose10000 mg/kg bw.In clinical sign observations, changes on urine composition,behavioral somnolence (general depressed activity) and dermatitis were observed.Hence,LD50 value was considered to be >10000 mg/kg bw,when rats were treated with test chemical orally. Thus, based on the above summarised studies,2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol] / C.I. Solvent Yellow 107 (67990-27-6) and it’s structurally similar read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol] / C.I. Solvent Yellow 107 (67990-27-6)cannot be classified for acute oral toxicity.Hence, based on the data available for the structurally similar read across, test chemical 2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol] / C.I. Solvent Yellow 107 (67990-27-6)is not likely to be toxic at the dose of 10000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/979e21b8-6940-4273-a1b2-f65760e7ff0b/documents/235e17ed-88f0-4909-8d78-f1ebedc23a58_494e7fca-2da9-408b-987a-24a3822d1e23.html,,,,,, "2,2'-[(3,3'-dimethyl[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4-nonylphenol]",67990-27-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/979e21b8-6940-4273-a1b2-f65760e7ff0b/documents/235e17ed-88f0-4909-8d78-f1ebedc23a58_494e7fca-2da9-408b-987a-24a3822d1e23.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "2,2'-[(3-acetamidophenyl)imino]diethyl diacetate",27059-08-1," LD50 was estimated to be 20024mg/kg bw when rats were exposed with 2,2'-[(3-acetamidophenyl)imino]diethyl diacetate (27059-08-1) orally. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b82e1d06-aebe-43b9-a407-6e0c9f3645e9/documents/a8dacfe1-0884-4cb1-b9b6-3b4694efba02_2579bcab-3c4b-41c2-bc90-5ffb0bce8986.html,,,,,, "2,2'-[(3-acetamidophenyl)imino]diethyl diacetate",27059-08-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b82e1d06-aebe-43b9-a407-6e0c9f3645e9/documents/a8dacfe1-0884-4cb1-b9b6-3b4694efba02_2579bcab-3c4b-41c2-bc90-5ffb0bce8986.html,,oral,LD50,"20,024 mg/kg bw",no adverse effect observed, "2,2'-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]diethyl diacetate",1533-78-4,"No adverse effects were observed that could be related to the treatment with the test substance. Under the study conditions, the NOEL was greater than the highest dose tested and determined to be > 1000 mg/kg bw/day in the subacute and >2500 mg/kg bw/day in the subchronic toxicity study with structural analogues. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7a5fdb6-59f2-4700-ae12-49ab3e95a690/documents/0c56aa90-cb50-417f-9bb4-649ca8adeeb2_4a24964e-e0a9-4dab-8d64-0561d57380bb.html,,,,,, "2,2'-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]diethyl diacetate",1533-78-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7a5fdb6-59f2-4700-ae12-49ab3e95a690/documents/0c56aa90-cb50-417f-9bb4-649ca8adeeb2_4a24964e-e0a9-4dab-8d64-0561d57380bb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"> 1,000 mg/kg bw/day",,rat "2,2'-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]diethyl diacetate",1533-78-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7a5fdb6-59f2-4700-ae12-49ab3e95a690/documents/0c56aa90-cb50-417f-9bb4-649ca8adeeb2_4a24964e-e0a9-4dab-8d64-0561d57380bb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"> 2,500 mg/kg bw/day",,rat "2,2'-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]diethyl diacetate",1533-78-4,"The substance did not cause any mortality in acute oral and inhalation studies with rats up to 5000 mg/kg bw and air saturation level, respectively. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7a5fdb6-59f2-4700-ae12-49ab3e95a690/documents/ebd119e2-40c9-41bb-af33-de71cd86b181_4a24964e-e0a9-4dab-8d64-0561d57380bb.html,,,,,, "2,2'-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate",3618-72-2,"No adverse effects were noted in the oral 90-day study in rats. The NOEL was greater than the highest dose tested and determined to be >2500 mg/kg bw/day, equivalent to >2490 mg a.i./kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/223f673a-8643-4e25-b892-f8b266e4ed9b/documents/60589644-963d-4c15-8813-ca02cbf5a839_87250972-22ff-4a24-a0e1-eab0e50935f6.html,,,,,, "2,2'-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate",3618-72-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/223f673a-8643-4e25-b892-f8b266e4ed9b/documents/60589644-963d-4c15-8813-ca02cbf5a839_87250972-22ff-4a24-a0e1-eab0e50935f6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"> 2,500 mg/kg bw/day",,rat "2,2'-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate",3618-72-2,The substance is practically non-toxic. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/223f673a-8643-4e25-b892-f8b266e4ed9b/documents/bcf66e72-595e-4c5b-a915-f06211a28bfe_87250972-22ff-4a24-a0e1-eab0e50935f6.html,,,,,, "2,2'-[[5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)azo]-2-methoxyphenyl]imino]diethyl diacetate",3618-72-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/223f673a-8643-4e25-b892-f8b266e4ed9b/documents/bcf66e72-595e-4c5b-a915-f06211a28bfe_87250972-22ff-4a24-a0e1-eab0e50935f6.html,,oral,LD50,"4,870 mg/kg bw",no adverse effect observed, "2,2'-[1,2-ethanediylbis(oxy)]bis(ethanethiol)",14970-87-7," The repeated dose toxicity of DIMERCAPTO-1,8-DIOXA-3,6-OCTANE (DMDO) was investigated in OECD 407 and 421 studies in rats.   OECD 407 study The repeated dose oral toxicity of DMDO was investigated in rats following daily oral administration for 4 consecutive weeks and recovery from any treatment-related effect during a treatment-free period of 2 weeks (Longobardi, 2018a). Three groups, each of 5 male and 5 female Sprague Dawley rats, received the test item by gavage at dosages of 20, 60 and 180 mg/kg/day for 4 consecutive weeks. A fourth similarly constituted group received the vehicle alone (0.5 % aqueous solution of carboxymethylcellulose) and acted as a control. Five additional animals for each sex were included in the high dose and control groups for recovery assessment. The following investigations were performed: daily clinical signs, weekly detailed clinical signs (removal from cage and open field observations), evaluation of sensory reactivity to stimuli and motor activity, body weight, food consumption, oestrous cycle, clinical pathological investigations (including bone marrow smears), terminal body weight, organ weights, macroscopic observations and histopathological examinations. Three male animals from Group 4 (dosed at 180mg/kg/day) were found dead during Weeks 3 and 4 of the treatment period. Decreased activity and dyspnoea or red staining of nose were the clinical signs observed in two of these animals on the day of death. Although some treatment-related changes were present at macroscopic and microscopic observations, these data did not allow to clearly establish the factor contributory to death. Decreased activity, dyspnoea, staining of nose and/or semi-closed eyes were observed during the treatment period at 180mg/kg/day, on daily occasions. These clinical signs were reversible at the end of the recovery period. No other significant signs of toxic or neurotoxic effects were seen during the in vivo phase of the study. No particular differences in oestrous cycle were noted between groups. Statistically significant reduction in body weight and body weight gain was observed in male and female animals of the high dose group, with higher severity in females, starting from Day 8 of the treatment period. These reductions were completely reversible only in male animals. Food consumption was not affected by treatment. Slight decrease of erythrocytes, haemoglobin and haematocrit was recorded in animals of both sexes dosed at 180mg/kg/day; reticulocytosis was recorded in the same animals. Platelets were increased in animals dosed at 180mg/kg/day. Fluctuations of some biochemical parameters were recorded in a number of treated animals. The severity of the findings observed was not considered to be suggestive of tissue/organ injury and could be related to metabolic changes. An increase in total bilirubin was also observed in the high dose animals. This increase, since is not associated with other hepatic markers finding, was not considered indicative of liver/cholestatic change. These changes were no longer observed at the end of the recovery period. No changes of toxicological relevance were observed in urinalysis at the end of treatment and recovery periods. An increase of erythroid cells was observed in the majority of male and female animals dosed at 180 mg/kg/day at the end of treatment period. This condition was regarded as the result of the anaemic condition observed in animals dosed at 180 mg/kg/day. This increase was still present in 1 male and 2 females dosed at 180 mg/kg/day at the end of recovery. Post mortem observations showed a statistically significant slight reduction of terminal body weight mainly in high dose females. Moreover, an increase of the absolute and relative weight of the spleen and a reduction of the absolute and relative weight of the thymus were observed, with statistical significance, in males and females dosed at 180mg/kg/day. Such organ weight variations were considered treatment-related also on the basis of histopathological results. A slight increase in the absolute and relative weight of the spleen was again observed in high dose animals. Macroscopic examination reported a swollen spleen in one high dose male and reduced size of the thymus in one high dose female, that could be considered treatment-related. These changes were no longer present at the end of recovery. At microscopic examination, treatment-related changes were seen in males and females receiving the test item at 180mg/kg/day. The effects mainly observed in the spleen consisted in mild to moderate increase of yellow/brown pigmentation, probably resulting from increased hemosiderin pigment associated with extramedullary haematopoiesis (EMH) and congestion in the red pulp of the spleen. The observed increases in EMH were characterized by a predominance of erythroid precursors in all treated animals. Such pathological patterns were associated with the increase in spleen weights and reflected a physiological effect or a consequence of the haematological alterations. Furthermore, minimal increases of apoptotic lymphocytes were mainly noted in the thymus of high dose females. The treatment-related changes were considered toward a complete recovery in the spleen and fully recovered in the thymus. In conclusion, signs of effects related to treatment with DMDO were observed in male and female animals when administered by oral gavage for 4 consecutive weeks at the dosage of 180mg/kg/day. Clinical signs, reduction in body weight, treatment-related histopathological changes in spleen and thymus were the major changes observed in male and, mainly, in female animals dosed at 180mg/kg/day. These signs were partially reversible after 2 weeks of recovery. Even if a reduction in body weight was observed also at 60mg/kg/day, this sign was not considered to be adverse, due to the low magnitude and complete reversibility. Therefore, it can be concluded that the mid-dose of 60 mg/kg/day is considered to be the No Observed Adverse Effect Level (NOAEL) for this study.   OECD 421 study The repeated dose effects of DMDO were investigated as part of an OECD 421 study, when administered orally to male and female Sprague Dawley SD rats at dosages of 50, 100 and 150mg/kg/day (Lonbogardi, 2018 b).The following investigations were performed on parental animals of all groups: mortality check, clinical signs, body weight, body weight gain, food consumption, thyroid hormone determination (only for parental males), macroscopic observations, organ weights and histopathological examination. Histopathological evaluation of reproductive organs/tissues was performed on all control and high dose males and females, as well as on all abnormalities detected during post mortem observation. The identification of the stages of the spermatogenic cycle was performed in the males from all dose groups. Three study animals (1 male and 1 female dosed at 150mg/kg/day, 1 female dosed at 100mg/kg/day) were found dead or humanely sacrificed during the study. A number of clinical signs and post mortem macroscopic and microscopic changes were observed in these animals. Minor clinical signs (hunched posture, pallor) were detected in the high dose males and females from the third week in vivo phase (mating phase). These were not considered of toxicological relevance. Reductions in body weight/body weight gain or body weight losses were observed in males and females dosed at 100 and 150mg/kg/day, starting from the mating phase up to termination. Reductions in food consumption were observed in the females dosed at 150mg/kg/day, starting from the pre-mating phase up to termination. Thyroid hormones (T3, T4 and TSH) did not show any changes of toxicological relevance in parental males. Post mortem observations of the parental animals revealed a reduction of terminal body weight (in males and females dosed at 150mg/kg/day), increases of the absolute and relative spleen weight (dosages of 100 and 150mg/kg/day), reductions of the absolute and/or relative thymus weight in both sexes (dosage of 150mg/kg/day) and absolute and relative epididymes weight of males dosed at 150mg/kg/day. Swollen or enlarged spleen and reduced size of the thymus were seen in animals dosed at 150mg/kg/day, as well as instances of small epididymides, seminal vesicle and testes in the males of this group. Microscopic examination revealed treatment-related changes in the spleen (increase of yellow/brown pigmentation, congestion, lymphoid depletion and for high dose females extramedullary haematopoesis) of males and females dosed at 100 and 150mg/kg/day, in the thymus (atrophy) of males and females dosed at 150mg/kg/day and in the testes and epididymes (germ cell degeneration) of males of the same group. Seminiferous tubules showed regular layering in the germinal epithelium in all control and males treated at 50 and 100mg/kg/day. In conclusion, effects on body weight and food consumption and post mortem effects on the spleen and thymus were observed in males and females dosed at 100 and 150mg/kg/day. No adverse effects for general toxicity were observed in male and female animals dosed at 50mg/kg/day. The NOAEL for parental toxicity was considered to be 50 mg/kg/day for males and females.   14 -days range finding study The toxicity of DMDO was investigated in rats, after oral administration for 2 weeks (Longobardi, 2018c). Three groups, each of 5 male and 5 female Sprague Dawley SD rats, received the test item once daily by gavage, at dose levels of 10, 30 and 100 mg/kg/day for 2 consecutive weeks. A fourth similarly constituted group received the vehicle alone (0.5% aqueous solution of carboxymethylcellulose) and acted as a control. The following investigations were performed: daily clinical signs, body weight, food consumption, post mortem organ weights and macroscopic observations. No mortality occurred during the study. No clinical signs were recorded in all treated animals. Body weights were similar between control and treated groups. No effects were observed on food consumption in either sex during the experimental period. No significant differences in organ weights were observed in treated animals, when compared to controls. Animals killed at termination did not show any macroscopic changes that could be considered treatment related. On the basis of the above results, DMDO, following daily oral administration at dose levels of 10, 30 and 100mg/kg/day for 2 weeks, did not show any signs of toxicity. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88439e9f-cd8e-46bb-8f07-9a4175684b28/documents/b92628c9-28e4-41ab-85a1-ecc20e3131a1_134225b3-7315-47a1-901f-109a140d2cd2.html,,,,,, "2,2'-[1,2-ethanediylbis(oxy)]bis(ethanethiol)",14970-87-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88439e9f-cd8e-46bb-8f07-9a4175684b28/documents/b92628c9-28e4-41ab-85a1-ecc20e3131a1_134225b3-7315-47a1-901f-109a140d2cd2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "2,2'-[1,2-ethanediylbis(oxy)]bis(ethanethiol)",14970-87-7," Acute oral toxicity The acute toxicity of DIMERCAPTO-1,8-DIOXA-3,6-OCTANE (DMDO) was investigated following a single oral administration to the Sprague-Dawley rat followed by a 14-day observation period (Caruso 2016). Experimental procedures were in agreement with the OECD guideline Number 423 (adopted on 17 December 2001). A first group of 3 female animals was dosed at a level of 300 mg/kg (Step 1), dose level selected on the basis of available information. A second group, similarly composed, was then dosed at the same dose level (Step 2). Since two animals died in Step 2, according to the step-wise procedure foreseen in the relevant guideline, a third group of 3 females was dosed at the lower dose level of 50 mg/kg (Step 3). Finally an additional group, similarly composed, was dosed at the same dose level (Step 4). No further doses were investigated, since the objective of the study had been achieved. All animals dosed at 300 mg/kg (Step 1) showed tremors, ataxia and piloerection. One animal was found dead and the others recovered from these signs on Day 2 of study. Tremors, ataxia and muscular rigidity were observed in all animals dosed at the same dose level (Step 2). Two animals were found dead, while the third one recovered on Day 2 of study. No mortality occurred and no clinical sign was seen in all animals dosed at 50mg/kg (Step 3 - Step 4). Body weight changes recorded during the study were within the expected range for this strain and age of animals. No abnormalities were observed at necropsy examination performed on termination of the observation period and in the animals found dead. These results demonstrate the acute toxicity expected (ATE) to be lower than 300 mg/kg body weight, but higher than 50 mg/kg body weight. Acute dermal toxicity The acute toxicity of DMDO was investigated following dermal administration of a single dose to the rat (Caruso, 2016). A single dose of 2000 mg/kg was administered to a group of 5 male and 5 female animals for 24 hours. After 14 days, all animals were killed and subjected to necropsy examination. No mortality occurred and no signs of toxicity were observed in male or female animals during the observation period. The body weight changes observed during the study were within the expected range for this species and age of animals. No significant abnormalities were found at necropsy in the animals at termination of the study. No abnormalities were observed at the treated site. These results indicate that the test item has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000 mg/kg. The lack of mortality demonstrates the Lethal Dose to be greater than 2000 mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88439e9f-cd8e-46bb-8f07-9a4175684b28/documents/938b4cdd-6bf0-4b44-b22e-a7c4623a29b8_134225b3-7315-47a1-901f-109a140d2cd2.html,,,,,, "2,2'-[1,2-ethanediylbis(oxy)]bis(ethanethiol)",14970-87-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88439e9f-cd8e-46bb-8f07-9a4175684b28/documents/938b4cdd-6bf0-4b44-b22e-a7c4623a29b8_134225b3-7315-47a1-901f-109a140d2cd2.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,2'-[1,3-phenylenebis(oxy)]bisethanol",102-40-9, An acute oral testing was performed on the test item according to the OECD 420. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System-Category 5). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bda50176-01fb-4a74-9b1b-66a09146a018/documents/11da00d6-24bb-4bd0-acc4-79e3b84acba0_05fda288-55cb-4191-9736-7cafcda11871.html,,,,,, "2,2'-[1,3-phenylenebis(oxy)]bisethanol",102-40-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bda50176-01fb-4a74-9b1b-66a09146a018/documents/11da00d6-24bb-4bd0-acc4-79e3b84acba0_05fda288-55cb-4191-9736-7cafcda11871.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2'-[azobis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole dihydrochloride",27776-21-2, one Guideline Study available. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4dcc1d8-007a-460b-93c5-bc04fbe660c5/documents/c8eda9a7-c028-4a6f-8e37-350a63cdb425_2666f19a-046c-4cc6-b57d-0e6b0dc2a8ed.html,,,,,, "2,2'-[azobis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole dihydrochloride",27776-21-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4dcc1d8-007a-460b-93c5-bc04fbe660c5/documents/c8eda9a7-c028-4a6f-8e37-350a63cdb425_2666f19a-046c-4cc6-b57d-0e6b0dc2a8ed.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2'-[azobis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole dihydrochloride",27776-21-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4dcc1d8-007a-460b-93c5-bc04fbe660c5/documents/345b3131-d61b-4251-8a71-29ffc6993855_2666f19a-046c-4cc6-b57d-0e6b0dc2a8ed.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, "2,2'-[azobis(1-methylethylidene)]bis[4,5-dihydro-1H-imidazole dihydrochloride",27776-21-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4dcc1d8-007a-460b-93c5-bc04fbe660c5/documents/345b3131-d61b-4251-8a71-29ffc6993855_2666f19a-046c-4cc6-b57d-0e6b0dc2a8ed.html,,inhalation,LC50,"5,100 mg/m3",no adverse effect observed, "2,2'-[ethane-1,2-diylbis(oxy)]bisethyl diacetate",111-21-7,Oral: NOAEL (rat) ≥ 796 (m) and 1195 (f) mg/kg bw/day (subchronic)Inhalation: NOAEC (rat) ≥ 227 mg/m³ (subacute) ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e070390-4019-49a9-93a7-0e628860a532/documents/IUC5-f2e9b363-d2b4-4cea-8d42-967145e8a851_163cc388-74cd-4399-a4b5-3655bc8c59d1.html,,,,,, "2,2'-[ethane-1,2-diylbis(oxy)]bisethyl diacetate",111-21-7,"Based on substance specific data and read-across from Propane-1,2-diyl diacetate (CAS 623-84-7):Oral: LD50 = 15594 mg/kg bw (lowest dose descriptor available)Inhalation: LC0 = 0.845 mg/L (vapour, max. att. conc.)Dermal: LD50 = 9040 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e070390-4019-49a9-93a7-0e628860a532/documents/IUC5-fb0b2c98-af19-42dd-8891-a4826ba2e7ed_163cc388-74cd-4399-a4b5-3655bc8c59d1.html,,,,,, "2,2'-[ethylenebis(oxy)]bisacetic acid",23243-68-7, oral: The LD50 was found to be > 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9521ab25-7057-4d22-951b-441b8314b89a/documents/b69f555a-f8fc-441f-ae54-e0fb53345f58_30d8ce96-fb3a-4677-bc28-a2dddf0e63ba.html,,,,,, "2,2'-[ethylenebis(oxy)]bisacetic acid",23243-68-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9521ab25-7057-4d22-951b-441b8314b89a/documents/b69f555a-f8fc-441f-ae54-e0fb53345f58_30d8ce96-fb3a-4677-bc28-a2dddf0e63ba.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "2,2'-[ethylenebis(oxymethylene)]bisoxirane",2224-15-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c876b050-4903-4f33-b770-06e6b3b42956/documents/364f907e-1fa3-4ddf-a128-2a16be46fc0f_9fbfb961-3dd2-4e72-a56b-90d61c80eda1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,12.5 mg/kg bw/day,,rat "2,2'-[ethylenebis(oxyphenyl-2,1-eneazo)]bis[N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide",77804-81-0,"OECD 408   The purpose of a 90 day repeated dose toxicity study on he analogue substance PO 36 was to evaluate the systemic toxicity profile of the test item, C.I. Pigment Orange 36 in Wistar rats when administered orally by gavage for a period of 90 consecutive daysand to assess the reversibilityof any effects during a subsequent 28days recovery period. This study was also intended to provide the information on major toxic effects, target organs and an estimation of a No Observed Adverse Effect Level (NOAEL).  The test item was weighed and suspended in vehicle,i.e.,0.5% Carboxymethylcellulose Sodium salt (medium viscosity) in Milli-Q®Water and administered to rats at the graduated dose levels of 111, 333 and 1000 mg/kg/day for low dose (G2), mid dose (G3) and high dose (G4 )/ high dose recovery (G4R) group rats, respectively. The rats in the vehicle control group (G1)/vehicle control recovery (G1R) groups received vehicle Carboxymethylcellulose alone. The dose volume administered was 10 mL/kg body weight. Each main group in the experiment was comprised of 10 male and 10 female rats and recovery groups comprised of 5 male and 5 female rats. The identity of the test item was provided by the Sponsor by a Certificate of Analysis (CoA). The authenticity of the test item was not determined at the test facility. The stability of the test item in the vehicle was established separately under Eurofins Advinus Study No. G19462 at 1 and 100 mg/mL. Based on the results, the test item was found to be stable and homogeneous in the vehicle up to 24 hours when stored at room temperature. During the conduct of this study, the prepared dose formulations and vehicle (Carboxy methylcellulose Sodium salt (medium viscosity) were analyzed for homogeneity and active ingredient (a.i.) concentration on Day 1 and during 2ndmonth (Day 34) and 3rdmonth (Day 63) of the treatment.The results indicated thatthe percent agreement of the analyzed concentrations were in the range, 85% to 115% of the claimed concentrations and the overall % RSD from six replicates at each dose level was<10.0%. This indicates that the prepared dose formulation met the acceptance criteria for concentration and % RSD. Each rat in the experiment was observed for clinical signs, mortality and morbidity. Ophthalmological examination was carried out for all the rats prior to start of treatment, at the end of treatment for main groups and at the end of recovery period for recovery groups. The body weights and food consumption were measured during in-life phase of the experiment. Neurological examinations were conducted towards the end of treatment (Day 84) for main groups and towards the end of recovery period (Day 117) for recovery groups.The clinical laboratory investigations such as haematology, coagulation, clinical chemistry, hormone analysis and urine analysis were performed at termination. Vaginal smear was examined in the female rats and the stage ofoestrous cycle was recordedprior to necropsy. All rats in the experiment were subjected to detailed necropsy and the organ weights and their ratios were derived as percent fasting body weights and brain weight. Histopathological examination was carried out on the preserved organs of the vehicle control (G1) and high dose(G4) group animals. Histopathological examination of the testes included a qualitative assessment of stages of spermatogenesis.In addition, gross lesions from all the animals were examined microscopically.There were no test item-related histopathological changes observed in any organ/tissue in high dose group (G4); hence, histopathological evaluation was not carried out in thelower dose (G2and G3) and recovery groups (G1R and G4R). Under the experimental conditions employed, the following results were obtained: ·        Clinical Signs and Mortality:Orangecolour faecal matter(light to dark) were observed at all the tested doses in both sexes. This could be due to physical nature of the test item. There were no mortality observed at any of the doses tested in both sexes. ·        Ophthalmological Examination:Ophthalmological examination did not reveal any ocular abnormalities. ·        Neurological Findings:No treatment-related neurological abnormalities /dysfunctions were observed at all the doses tested. ·        Body Weights:Treatment did not affect body weight at all the tested doses in either sex. ·        Food Consumption:Treatment did not affect food consumption at all the tested doses in either sex. ·        Haematology, Coagulation, Clinical Chemistry and urine parameters:There were no test item related alterations observed at any of the tested dose levels in either sex. ·        Thyroid Hormone Profile:Thyroid hormone profile (TSH, T4 and T3) was not affected in both sexes across the treated groups when compared to the concurrent vehicle control group. ·        Terminal Fasting Body Weights and Organ Weights:No significant changes in terminal fasting body weights and organ weights attributed to test item were observedat any of the tested dose levels in either sex. ·        Sperm Parameter:There were no test item-related changes in any of the sperm parameters. ·        Gross pathology:There were no test item-related gross pathological changes observed in both sexes. Orange colouration of intestinal contents (ileum, cecum, colon and rectum) observed in both sexes at all doses at the end of treatment period was attributed to the test item colour. ·        Histopathology:There were no test item-related microscopic lesions in any evaluated organs or tissues of male and female rats at the end of treatment period at tested dose levels. No Observed Adverse Effect Level (NOAEL): As there were no treatment-related adverse effects observed up to the highest dose the No Observed Adverse Effect Level (NOAEL)for systemic toxicity of the test item is considered to be 1000 mg/kg/day.   OECD 422 The analogue substance Pigment Orange 36 was administered during a study according to OECD TG 422 to male rats for 39 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum.   The following dose levels were applied: Group 1:                        0 mg/kg body weight/day (control group) Group 2:                    100 mg/kg body weight/day Group 3:                    300 mg/kg body weight/day Group 4:                   1000 mg/kg body weight/day   A standard dose volume of 10 mL/kg body weight with a daily adjustment to the actual body weight was used. Control animals were dosed with the vehicle alone (highly purified water).   The following results were obtained:  MORTALITY AND GENERAL TOLERABILITY OF PARENTAL ANIMALS  All animals survived the scheduled study period.Feces stained red with dose-dependent intensity of discoloration were noted in all males and females in all dose groups starting from day 2 of the treatment until completion of the study. This observation was due to staining properties of the test item.  No further test item-related clinical signs or observations were noted in males or females at any dose level.   FUNCTIONAL OBSERVATIONAL BATTERY IN PARENTAL ANIMALS  No test item-related findings were noted during the functional observational battery tests in males or females at any dose level.   FOOD CONSUMPTION OF PARENTAL ANIMALS  No effects on food consumption were noted in males or females at any dose level.   BODY WEIGHTS OF PARENTAL ANIMALS  In males at the dose level of 1000 mg/kg bw/day, a slight but statistically significant lower body weight gain was noted during the pre-pairing period. No differences in body weight gain were noted at any dose level during the remaining study period. Body weights of males in all dose groups were similar to the respective control values during the entire study period. Because reduction in body weight gain at the high-dose levels was reversible and did not cause significant changes in body weights, this effect was considered not to be adverse.  Body weights and body weight gain of females were not affected by the treatment at any dose level.   CLINICAL LABORATORY INVESTIGATIONS IN PARENTAL ANIMALS  No test item-related effects on hematology and clinical biochemistry parameters were noted in males or females at any dose level.  No changes in urine parameters were noted in males at any dose level.   REPRODUCTION AND BREEDING DATA  Mating performance, fertility, corpora lutea count, duration of gestation, implantation rate and post-implantation loss, litter size or postnatal loss were not affected by the treatment with the test item.   SEMINOLOGY AND SPERMATID COUNT IN PARENTAL MALES Effects on sperm motility which might be test item-related were noted in all dose groups. Mean count of progressive sperms was statistically significantly reduced at the dose levels of 1000, 300 and 100 mg/kg bw/day, mean count of stationary sperms was statistically significantly increased at the dose levels of 1000 and 100 mg/kg bw/day and mean count of not motile sperms was statistically significantly increased at the dose level of 1000 and 300 mg/kg bw/day. But a significant dose dependent trend couldn’t be established. In the absence of any findings during necropsy or histopathological examination of male reproductive organs as well as in the absence of any effects on reproduction, the differences in sperm motility were considered not to be adverse. These findings were shown to be artefacts due to processing of the cells rather than effects of the test material in a separate study described hereafter (see chapter 7.8.1 Key_Sperm-motility)   ORGAN WEIGHTS OF PARENTAL ANIMALS  No changes in absolute organ weights or organ weights to body weights and to brain weights ratios were noted in males or females at any dose level.   MACROSCOPICAL FINDINGS AND HISTOPATHOLOGICAL EXAMINATIONS OF PARENTAL ANIMALS  Type and distribution of findings noted during macroscopical examination did not indicate any test item-related effect.  Treatment with the test item did not cause pathological findings. All findings recorded were within the range of normal background lesions which may be recorded in animals of this strain and age.   FINDINGS IN PUPS AT FIRST LITTER CHECK AND DURING LACTATION  No test item-related findings were noted in pups during first litter check and during lactation at any dose level.  Pups sex ratio was not affected by the exposure to the test item at any dose level.   PUP WEIGHTS TO DAY 4 POST PARTUM  Body Weights and body weight gain of pups were not affected by the treatment with the test item at any dose level.   MACROSCOPICAL FINDINGS OF PUPS  No test item-related findings were noted at macroscopic examination of pups at any dose level.   CONCLUSION Based on these results, the NOAEL (No Observed Adverse Effect Level) for general toxicity in males and females and for reproduction/developmental toxicity in this study was considered to be 1000 mg/kg bw/day, the highest dose level tested. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80b7faee-aaca-4730-b74d-06c613dcef68/documents/c50a9d19-3f05-4064-803c-118d0e38eb21_06324781-90c3-4f65-829f-5d5bad75bd0e.html,,,,,, "2,2'-[ethylenebis(oxyphenyl-2,1-eneazo)]bis[N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide",77804-81-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80b7faee-aaca-4730-b74d-06c613dcef68/documents/c50a9d19-3f05-4064-803c-118d0e38eb21_06324781-90c3-4f65-829f-5d5bad75bd0e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2'-[ethylenebis(oxyphenyl-2,1-eneazo)]bis[N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide",77804-81-0," Single application of 5000 mg/kg bw of the test substance did not cause lethality in female Wistar rats during the 14 day observation period, resulting in a LD50 > 5000 mg/kg bw. Exposure of male and female Wistar rats to 1274 mg/m³ test item (i.e. maximum technically feasible concentration) for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 1274 mg/m³. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80b7faee-aaca-4730-b74d-06c613dcef68/documents/ce176c5f-5d07-42cc-8ceb-274ac64b65b3_06324781-90c3-4f65-829f-5d5bad75bd0e.html,,,,,, "2,2'-[ethylenebis(oxyphenyl-2,1-eneazo)]bis[N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide",77804-81-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80b7faee-aaca-4730-b74d-06c613dcef68/documents/ce176c5f-5d07-42cc-8ceb-274ac64b65b3_06324781-90c3-4f65-829f-5d5bad75bd0e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,2'-[ethylenebis(oxyphenyl-2,1-eneazo)]bis[N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide",77804-81-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80b7faee-aaca-4730-b74d-06c613dcef68/documents/ce176c5f-5d07-42cc-8ceb-274ac64b65b3_06324781-90c3-4f65-829f-5d5bad75bd0e.html,,inhalation,LC50,"1,274 mg/m3",no adverse effect observed, "2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]",23235-61-2, 28 -day and 90- day oral studies are available for di-TMP. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12d9baef-8511-4a87-a52f-6b5e73c9ccfe/documents/979e88a9-ee2b-4154-9067-fd32a5195934_3e0e74f5-941e-4dc0-ba10-a2caf77d7cb4.html,,,,,, "2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]",23235-61-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12d9baef-8511-4a87-a52f-6b5e73c9ccfe/documents/979e88a9-ee2b-4154-9067-fd32a5195934_3e0e74f5-941e-4dc0-ba10-a2caf77d7cb4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]",23235-61-2,The acute oral LD50 of the susbtance in mice is 14.5 g/kg bw. The acute 4-hour inhalation LC50 of the substance is >5.15 mg/L in rats. A waiver is proposed for dermal toxicity. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12d9baef-8511-4a87-a52f-6b5e73c9ccfe/documents/57007370-654b-497f-ad2b-24e3ce3a99bf_3e0e74f5-941e-4dc0-ba10-a2caf77d7cb4.html,,,,,, "2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]",23235-61-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12d9baef-8511-4a87-a52f-6b5e73c9ccfe/documents/57007370-654b-497f-ad2b-24e3ce3a99bf_3e0e74f5-941e-4dc0-ba10-a2caf77d7cb4.html,,oral,LD50,"14,500 mg/kg bw",no adverse effect observed, "2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]",23235-61-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12d9baef-8511-4a87-a52f-6b5e73c9ccfe/documents/57007370-654b-497f-ad2b-24e3ce3a99bf_3e0e74f5-941e-4dc0-ba10-a2caf77d7cb4.html,,inhalation,LC50,"5,150 mg/m3",no adverse effect observed, "2,2'-[propane-1,3-diylbis(oxy)]bis(3'',5,5''-tri-tert-butyl-5'-methyl-1,1':3',1''-terphenyl-2'-ol)",1042662-40-7, The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System: Unclassified). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/760c6890-9020-4e01-89e8-20635b9ecb93/documents/fe0f0a95-c8c7-4c59-935a-cbb7ddb1c584_8a2317b5-a4e2-471e-9ba4-96e2b6d68715.html,,,,,, "2,2`-[6-(phenylamino)-1,3,5-triazine-2,4-diyl]diphenol",1248-66-4,NOAEL (oral; subacute; rat) = 200 mg/kg bw/day ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/065ee0f5-873e-4ff0-9b96-0dbd7e5fc818/documents/2381a538-deeb-4a4f-bf9d-45d06388ca73_b31b4de9-49ae-4201-8c5c-c9bd1fee24c9.html,,,,,, "2,2`-[6-(phenylamino)-1,3,5-triazine-2,4-diyl]diphenol",1248-66-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/065ee0f5-873e-4ff0-9b96-0dbd7e5fc818/documents/2381a538-deeb-4a4f-bf9d-45d06388ca73_b31b4de9-49ae-4201-8c5c-c9bd1fee24c9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "2,2`-[6-(phenylamino)-1,3,5-triazine-2,4-diyl]diphenol",1248-66-4,Oral: LD50 > 2000 mg/kg bw (rats)Dermal: LD50 > 2000 mg/kg bw (rats) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/065ee0f5-873e-4ff0-9b96-0dbd7e5fc818/documents/87fd86ef-69a2-4451-8e40-8886d81f6e47_b31b4de9-49ae-4201-8c5c-c9bd1fee24c9.html,,,,,, "2,2`-[6-(phenylamino)-1,3,5-triazine-2,4-diyl]diphenol",1248-66-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/065ee0f5-873e-4ff0-9b96-0dbd7e5fc818/documents/87fd86ef-69a2-4451-8e40-8886d81f6e47_b31b4de9-49ae-4201-8c5c-c9bd1fee24c9.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,2`-[6-(phenylamino)-1,3,5-triazine-2,4-diyl]diphenol",1248-66-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/065ee0f5-873e-4ff0-9b96-0dbd7e5fc818/documents/87fd86ef-69a2-4451-8e40-8886d81f6e47_b31b4de9-49ae-4201-8c5c-c9bd1fee24c9.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,20-dichloro-13,31-diethyl-4,22-dioxa-13,18,31,36-tetraazanonacyclo[19.15.0.03,19.05,17.06,14.07,12.023,25.024,32.025,30]hexatriaconta-1(36),2,5,7,9,11,14,16,18,20,23,25,27,29,32,34-hexadecaene",215247-95-3,"Repeated oral toxicity: An OECD test guideline and GLP-compliant 28-day oral toxicity study including a 14-day recovery period was performed with the test item (Pigment Violet 23). Groups of 5 male and 5 female Wistar rats received doses of 0, 50, 250 and 2000 mg/kg bw by daily gavage for 28 days; extra 5 animals per sex in the control and high dose group were allowed 14 days of recovery. No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). A No Observed Adverse Effect Level (NOAEL) for the test item of 1000 mg/kg/day was established. The 90-day repeated dose toxicity study was waived; substance is not classified for this endpoint. Repeated dermal toxicity: The dermal route was waived; substance is not classified for this endpoint. The substance is considered not to exert any local or systemic adverse effects. Repeated inhalation toxicity: A subacute inhalation study including a prolonged recovery period and investigations of BALF and basic toxikokinetics is proposed. The subchronic inhalation study is waived. When aerosolized in respirable form, the substance is considered likely to behave as extremely poorly soluble particles. Effects of such particles can be assessed with sufficient certainty on the basis of the proposed subacute study results. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable without restriction ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/081aff0e-cfd2-477c-9435-6b48526527cb/documents/b93a68ea-44e4-4598-bb30-08c026b984b1_a95597f3-d8fe-487e-ace1-763f4e037080.html,,,,,, "2,20-dichloro-13,31-diethyl-4,22-dioxa-13,18,31,36-tetraazanonacyclo[19.15.0.03,19.05,17.06,14.07,12.023,25.024,32.025,30]hexatriaconta-1(36),2,5,7,9,11,14,16,18,20,23,25,27,29,32,34-hexadecaene",215247-95-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/081aff0e-cfd2-477c-9435-6b48526527cb/documents/b93a68ea-44e4-4598-bb30-08c026b984b1_a95597f3-d8fe-487e-ace1-763f4e037080.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,20-dichloro-13,31-diethyl-4,22-dioxa-13,18,31,36-tetraazanonacyclo[19.15.0.03,19.05,17.06,14.07,12.023,25.024,32.025,30]hexatriaconta-1(36),2,5,7,9,11,14,16,18,20,23,25,27,29,32,34-hexadecaene",215247-95-3,"Acute oral toxicity: The test item (Pigment Violet 23) did not cause any mortality or clinical signs or necropsy findings after single oral gavage administration to male and female rats at 2000 mg/kg bw in an OECD guideline and GLP compliant study. The LD50 (male/female rat) was greater than 2000 mg/kg body weight.   Acute dermal toxicity: The test item (Read-across substance HPPP Additive V11) did not cause any mortality or clinical signs or necropsy findings after single dermal exposure of male and female rats at 2000 mg/kg bw in a OECD guideline and GLP compliant study. The LD50 (male/female rat) was greater than 2000 mg/kg body weight. Acute inhalation toxicity: Study was waived; substance is not classified for this endpoint. When aerosolized in respirable form, the substance is considered likely to behave like an inert dust. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable without restriction Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): reliable without restriction ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/081aff0e-cfd2-477c-9435-6b48526527cb/documents/1872335f-a6a5-49a5-a40b-6f8ef35347cb_a95597f3-d8fe-487e-ace1-763f4e037080.html,,,,,, "2,20-dichloro-13,31-diethyl-4,22-dioxa-13,18,31,36-tetraazanonacyclo[19.15.0.03,19.05,17.06,14.07,12.023,25.024,32.025,30]hexatriaconta-1(36),2,5,7,9,11,14,16,18,20,23,25,27,29,32,34-hexadecaene",215247-95-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/081aff0e-cfd2-477c-9435-6b48526527cb/documents/1872335f-a6a5-49a5-a40b-6f8ef35347cb_a95597f3-d8fe-487e-ace1-763f4e037080.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,20-dichloro-13,31-diethyl-4,22-dioxa-13,18,31,36-tetraazanonacyclo[19.15.0.03,19.05,17.06,14.07,12.023,25.024,32.025,30]hexatriaconta-1(36),2,5,7,9,11,14,16,18,20,23,25,27,29,32,34-hexadecaene",215247-95-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/081aff0e-cfd2-477c-9435-6b48526527cb/documents/1872335f-a6a5-49a5-a40b-6f8ef35347cb_a95597f3-d8fe-487e-ace1-763f4e037080.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,2'-azobis[2,4-dimethylvaleronitrile]",4419-11-8, one Guideline study on subacute repeated dose toxicity available. one pre-OECD Guideline study on subchronic repeated dose toxicity available. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1233c2c-e7d2-48cc-bb5c-cfd0c73e6d7d/documents/c743a98f-ec03-4fe2-b772-dd6b8d1133c6_5d11a2dd-e86d-450a-ba55-7e55abdd544f.html,,,,,, "2,2'-azobis[2,4-dimethylvaleronitrile]",4419-11-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1233c2c-e7d2-48cc-bb5c-cfd0c73e6d7d/documents/c743a98f-ec03-4fe2-b772-dd6b8d1133c6_5d11a2dd-e86d-450a-ba55-7e55abdd544f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,700 mg/kg bw/day,,rat "2,2'-azobis[2,4-dimethylvaleronitrile]",4419-11-8, one study on acute toxicity by oral route and one study on acute toxicity by inhalative route available. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1233c2c-e7d2-48cc-bb5c-cfd0c73e6d7d/documents/257806a3-ac8a-4773-b060-83b35069662e_5d11a2dd-e86d-450a-ba55-7e55abdd544f.html,,,,,, "2,2'-azobis[2,4-dimethylvaleronitrile]",4419-11-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1233c2c-e7d2-48cc-bb5c-cfd0c73e6d7d/documents/257806a3-ac8a-4773-b060-83b35069662e_5d11a2dd-e86d-450a-ba55-7e55abdd544f.html,,inhalation,discriminating conc.,9.3 mg/m3,no adverse effect observed, "2,2'-azobis[2-methylbutyronitrile]",13472-08-7,"A NOAEL of 15 mg/kg/day was reported from an OECD 422 Guideline study in rats with 2,2’-Azodi(2-methylbutyronitrile). Read-across from an OECD 408 supported by an OECD 422 Guideline study in rats with 2,2’-azobis(isobutyronitrile) has shown a consistent toxicity profile and lead to a 90-day 10 mg/kg/day NOAEL. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): All data is derived from GLP guideline studies and show a consistent toxicity profile. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/325113d0-409c-4e17-9390-c71c0773eeb2/documents/IUC5-5d857aeb-e435-4385-8738-b312ed308466_f59967f6-243a-43f9-b136-8c281604a163.html,,,,,, "2,2'-azobis[2-methylbutyronitrile]",13472-08-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/325113d0-409c-4e17-9390-c71c0773eeb2/documents/IUC5-5d857aeb-e435-4385-8738-b312ed308466_f59967f6-243a-43f9-b136-8c281604a163.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "2,2'-azobis[2-methylbutyronitrile]",13472-08-7,"Oral: OECD 401; rat LD50: 337 mg/kg. Dermal (based on read across): OECD 402; rat LD50 >2000 mg/kg.Inhalation: OECD 403; rat 4-hr LC50 >8.9 mg/L (8900 mg/m3). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Guideline (OECD 401) study performed under GLP. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Low respirability of atmosphere was noted. However, considered adequate hazard evaluation of the material as supplied ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/325113d0-409c-4e17-9390-c71c0773eeb2/documents/IUC5-83c7d747-5fa0-42eb-bb38-56b7bcb6c5aa_f59967f6-243a-43f9-b136-8c281604a163.html,,,,,, "2,2'-azobis[2-methylbutyronitrile]",13472-08-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/325113d0-409c-4e17-9390-c71c0773eeb2/documents/IUC5-83c7d747-5fa0-42eb-bb38-56b7bcb6c5aa_f59967f6-243a-43f9-b136-8c281604a163.html,,oral,LD50,337 mg/kg bw,adverse effect observed, "2,2'-azobis[2-methylbutyronitrile]",13472-08-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/325113d0-409c-4e17-9390-c71c0773eeb2/documents/IUC5-83c7d747-5fa0-42eb-bb38-56b7bcb6c5aa_f59967f6-243a-43f9-b136-8c281604a163.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2'-azobis[2-methylbutyronitrile]",13472-08-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/325113d0-409c-4e17-9390-c71c0773eeb2/documents/IUC5-83c7d747-5fa0-42eb-bb38-56b7bcb6c5aa_f59967f6-243a-43f9-b136-8c281604a163.html,,inhalation,LC50,"8,900 mg/m3",no adverse effect observed, "2,2'-azobis[2-methylpropionamidine] dihydrochloride",2997-92-4,"One 28 -days repeated dose toxicity study for the oral route is available. A NOAEL of 25 mg/kg bw/day is identified. No studies for other routes are available. One 90 -days repeated dose toxicity study for the oral route is available. A NOAEL of 150 mg/kg bw/day is identified. No studies for other routes are available. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): One 28 day repeated dose toxicity study and one 90 day repeated dose toxictiy study available. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1bb3e1f8-779d-4935-964f-77086a2e3e6c/documents/a839a00f-84c4-4312-9b28-45f85f261d6e_461cc62f-6bac-4c5e-a160-3445c5aadc59.html,,,,,, "2,2'-azobis[2-methylpropionamidine] dihydrochloride",2997-92-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1bb3e1f8-779d-4935-964f-77086a2e3e6c/documents/a839a00f-84c4-4312-9b28-45f85f261d6e_461cc62f-6bac-4c5e-a160-3445c5aadc59.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "2,2'-azobis[2-methylpropionamidine] dihydrochloride",2997-92-4,The LD50 for oral toxicity is 500 mg/kg bw.The LD50 for dermal toxicity is above 2000 mg/kg bw.No information on inhalative toxicity available. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bb3e1f8-779d-4935-964f-77086a2e3e6c/documents/ef204545-e722-49b6-b5aa-dfc3f3a16977_461cc62f-6bac-4c5e-a160-3445c5aadc59.html,,,,,, "2,2'-azobis[2-methylpropionamidine] dihydrochloride",2997-92-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bb3e1f8-779d-4935-964f-77086a2e3e6c/documents/ef204545-e722-49b6-b5aa-dfc3f3a16977_461cc62f-6bac-4c5e-a160-3445c5aadc59.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "2,2'-azobis[2-methylpropionamidine] dihydrochloride",2997-92-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bb3e1f8-779d-4935-964f-77086a2e3e6c/documents/ef204545-e722-49b6-b5aa-dfc3f3a16977_461cc62f-6bac-4c5e-a160-3445c5aadc59.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2'-azobis[4-methoxy-2,4-dimethylvaleronitrile]",15545-97-8,one Guideline study available with reliability Klimisch 1 ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3bbe595-7167-42d0-86b5-8cbd3e56cbd8/documents/ff0d2dc9-ae86-4d82-ba59-fcf1108cdf96_d5a767e7-d96d-49b2-9c1e-530b2ce41eb7.html,,,,,, "2,2'-azobis[4-methoxy-2,4-dimethylvaleronitrile]",15545-97-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3bbe595-7167-42d0-86b5-8cbd3e56cbd8/documents/ff0d2dc9-ae86-4d82-ba59-fcf1108cdf96_d5a767e7-d96d-49b2-9c1e-530b2ce41eb7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "2,2'-azobis[4-methoxy-2,4-dimethylvaleronitrile]",15545-97-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3bbe595-7167-42d0-86b5-8cbd3e56cbd8/documents/07485d2d-0f03-4f8f-ba71-a3299bddcf89_d5a767e7-d96d-49b2-9c1e-530b2ce41eb7.html,,oral,LD50,"2,028 mg/kg bw",adverse effect observed, "2,2'-azobis[4-methoxy-2,4-dimethylvaleronitrile]",15545-97-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3bbe595-7167-42d0-86b5-8cbd3e56cbd8/documents/07485d2d-0f03-4f8f-ba71-a3299bddcf89_d5a767e7-d96d-49b2-9c1e-530b2ce41eb7.html,,inhalation,discriminating conc.,"3,200 mg/m3",no adverse effect observed, "2,2'-bipyridyl",366-18-7," Two studies for acute oral toxicity are available. Groce 1982: LD50 values (rat, oral) of 100 and 107 mg/kg bw for male and female rats were reported. Williamson 1972: LD50 (rat, oral) between 250 and 500 mg/kg bw. Four studies for acute dermal toxicity are available. Williamson (1972): LD50 (rat, dermal) between 625 and 1250 mg/kg bw. Allen (1987a): The LD50 (rat dermal) of the test item was found to be between 0.25 and 0.6 mL/kg bw. A conversion into mg/kg bw was not possible due to missing information on density of the test item. Allen (1987b): The LD50 (rat dermal) of the test item was found to be between 400 and 1000 mg/kg bw. Allen (1987c): The LD50 (rat dermal) of the test item was >400 mg/kg bw. No data are available on inhalation toxicity of 2,2’-bipyridine. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c4a65de-8c80-4ca1-8742-e6c8bfc0f5a8/documents/ab168571-9177-4666-9128-e236b9b840c7_d4a2e901-99b3-417b-aefc-af764d0820c0.html,,,,,, "2,2'-bipyridyl",366-18-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c4a65de-8c80-4ca1-8742-e6c8bfc0f5a8/documents/ab168571-9177-4666-9128-e236b9b840c7_d4a2e901-99b3-417b-aefc-af764d0820c0.html,,oral,LD50,100 mg/kg bw,adverse effect observed, "2,2'-bipyridyl",366-18-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c4a65de-8c80-4ca1-8742-e6c8bfc0f5a8/documents/ab168571-9177-4666-9128-e236b9b840c7_d4a2e901-99b3-417b-aefc-af764d0820c0.html,,dermal,discriminating dose,625 mg/kg bw,adverse effect observed, "2,2-Bis(2-aminoethoxy)propane",127090-71-5, Studies on acute toxicity do not need to be conducted because the substance is classified as corrosive to skin (Cat.1B). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/442ee4fb-39ba-4fc3-ab7d-f14414eefff8/documents/3bd0aec2-cb2a-4bfb-9756-f51e5bef0a9c_eb0235b3-5354-4480-86da-1c2463c87153.html,,,,,, "2,2-Bis(2-aminopropoxy)propane",2267262-12-2, Studies on acute toxicity do not need to be conducted because the substance is classified as corrosive to skin (Cat.1B). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0c4f943-923f-4823-abbf-0db70bee0be5/documents/6ca7810a-1026-4458-9a2d-15d2c55385ff_3e931c5e-74e9-47d5-9373-33f3e42d8a49.html,,,,,, "2,2-bis(methylthio)propane",6156-18-9,"The potential repeated dose toxicity of bismethylthiopropane (BMTP) was evaluated following daily oral administration (gavage) to rats in studies conducted according to OECD guidelines no. 408, 407 and 421. The No Observed Adverse Effect Level (NOAEL) was established at the dose-level of 300 mg/kg/day in the oral subchronic repeated dose toxicity (OECD 408) study. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab23168b-3eb9-4863-bdad-c3d794d965c2/documents/IUC5-1b0c0759-0475-4025-8270-5213bffc0b54_2d9db00b-025e-4eb5-a006-4ed9a2297a1a.html,,,,,, "2,2-bis(methylthio)propane",6156-18-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab23168b-3eb9-4863-bdad-c3d794d965c2/documents/IUC5-1b0c0759-0475-4025-8270-5213bffc0b54_2d9db00b-025e-4eb5-a006-4ed9a2297a1a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat "2,2-bis(methylthio)propane",6156-18-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab23168b-3eb9-4863-bdad-c3d794d965c2/documents/IUC5-1b0c0759-0475-4025-8270-5213bffc0b54_2d9db00b-025e-4eb5-a006-4ed9a2297a1a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2,2-bis(methylthio)propane",6156-18-9,"2,2 -bis(methylthio) propane is of low toxicity in rats by the oral, dermal, and inhalation routes. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab23168b-3eb9-4863-bdad-c3d794d965c2/documents/IUC5-51e1c23b-d8f7-494a-8359-37cc9055bb2e_2d9db00b-025e-4eb5-a006-4ed9a2297a1a.html,,,,,, "2,2-bis(methylthio)propane",6156-18-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab23168b-3eb9-4863-bdad-c3d794d965c2/documents/IUC5-51e1c23b-d8f7-494a-8359-37cc9055bb2e_2d9db00b-025e-4eb5-a006-4ed9a2297a1a.html,,oral,LD0,"2,000 mg/kg bw",no adverse effect observed, "2,2-bis(methylthio)propane",6156-18-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab23168b-3eb9-4863-bdad-c3d794d965c2/documents/IUC5-51e1c23b-d8f7-494a-8359-37cc9055bb2e_2d9db00b-025e-4eb5-a006-4ed9a2297a1a.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, "2,2-bis(methylthio)propane",6156-18-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab23168b-3eb9-4863-bdad-c3d794d965c2/documents/IUC5-51e1c23b-d8f7-494a-8359-37cc9055bb2e_2d9db00b-025e-4eb5-a006-4ed9a2297a1a.html,,inhalation,LC0,"20,200 mg/m3",no adverse effect observed, "2,2-bis[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate",25811-35-2," The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.The available subchronic repeated dose oral toxicity studies resulted in NOAEL of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC >= 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of > = 2000 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db60bb0e-93b6-4339-8574-6fef793e2957/documents/IUC5-da617e4c-3d58-4666-9c0c-66adc2ebb592_7df80317-d086-4fa1-94ac-8cb1ce452a23.html,,,,,, "2,2-bis[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate",25811-35-2," The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401, 423, and 425, GLP, analogue approach)Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, GLP, analogue approach)Acute toxicity: Inhalation LC50 (rat, m/f): > 4.06, 5.1 and 5.5 mg/mL (OECD 403, GLP, analogue approach) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db60bb0e-93b6-4339-8574-6fef793e2957/documents/IUC5-039ba875-3da6-4e4f-b575-a11633eda963_7df80317-d086-4fa1-94ac-8cb1ce452a23.html,,,,,, "2,2-bis[[(1-oxopentyl)oxy]methyl]propane-1,3-diyl divalerate",15834-04-5,All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7290af9-dbce-4362-aeff-a7be1c7bce61/documents/IUC5-3bee8ea8-9bb7-426f-b4e4-c21647768fee_69016508-3589-46a7-a3cd-849d9b71872e.html,,,,,, "2,2-bis[[(1-oxopentyl)oxy]methyl]propane-1,3-diyl divalerate",15834-04-5,"OralWoE: LD50 oral >2000 mg/kg bw (RA-S, CAS 85116-93-4, Cognis, Potokar 1983, Ac. Tox. oral, RL4)WoE: LD50 oral >2000 mg/kg bw (RA-S, CAS 68424-31-7, Croda, Robinson, 1991, Ac. Tox. oral, RL4)WoE: LD50 oral >2000 mg/kg bw (RA-S, CAS 131459-39-7, Croda, Allen, 1999, Acute oral, rat, RL2)DermalLD50 dermal: >2000 mg/kg bw (RA-S, CAS 131459-39-7, Key, Croda, Allen, 1999, acute dermal, rat, RL2)InhalationLD50 inhalation: > 5100 mg/m3 air (aerosol) (RA-S, CAS 68424-31-7, Key, Croda, Parr-Dobrzanski, 1994, acute tox: inhal, rat, RL2) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7290af9-dbce-4362-aeff-a7be1c7bce61/documents/IUC5-6894fa68-ef36-465c-bcda-d2673c963d32_69016508-3589-46a7-a3cd-849d9b71872e.html,,,,,, "2,2-bis[[(2-hexyl-1-oxodecyl)oxy]methyl]-1,3-propanediyl bis(2-hexyldecanoate)",60623-04-3," The 90 day repeat dose study (gavage study with 28 day recovery) for 146289 -36 -3 , a PE ester of the polyol ester category, exhibited a NOAEL >= 1000 mg/kg/day, at the highest experimental dose. No clinical signs, changes in food consumption, or mortality were noted at the highest dose. Some clinical biochemistry changes were noted, but not found to be significant. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/840f375c-99da-4755-b688-67b3ce17b46a/documents/b614bd7f-2ef9-4204-b522-10004dc4e304_97ff2fd8-e743-459e-a98a-69af4723aadd.html,,,,,, "2,2-bis[[(2-hexyl-1-oxodecyl)oxy]methyl]-1,3-propanediyl bis(2-hexyldecanoate)",60623-04-3," Acute oral on registered substance. The purpose of the study was to evaluate the potential toxic effect of the test item 2,2-bis[[(2-hexyl-1-oxodecyl)oxy]methyl]-1,3-propanediyl bis(2-hexyldecanoate) when administered as a single oral dose to Wistar rats. The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used. Available information indicated that the test item is likely to be non-toxic; therefore, a limit dose of 2000 mg/kg was used as a starting dose. Two groups of 3 females were dosed. All 6 females survived the limit dose. The limit dose of 2000 mg/kg did not cause death, evident signs of toxicity or body weight loss during the 14-day long observation period. Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg of OECD Guideline 423 it can be concluded that the LD50 of the test item 2,2-bis[[(2-hexyl-1-oxodecyl)oxy]methyl]-1,3 - propanediyl bis(2-hexyldecanoate) is greater than 2000 mg/kg body weight after single oral administration to Wistar rats. An acute dermal toxicity test (OECD 402) was conducted on CAS 62125 -22 -8, a polyol ester member of the category. Test material with no vehicle was placed on clipped skin and occluded. The single dose was 2000 mg/kg bw. Exposure for 24 hours was allowed and then the test material was removed. Daily observations were made for 14 days, with post-dose body weight determinations at 7 and 14 days. No mortality, clinical signs, gross pathology, or body weight effects were noted. Therefore the effect level was > 2000 mg/kg bw. Thus no hazard for acute oral, inhalation, and dermal toxicity was identified. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/840f375c-99da-4755-b688-67b3ce17b46a/documents/73803e6b-491d-4cea-b3d1-b8d56910a96b_97ff2fd8-e743-459e-a98a-69af4723aadd.html,,,,,, "2,2-bis[[(mercaptoacetyl)oxy]methyl]-1,3-propanediyl bis(mercaptoacetate)",10193-99-4," Based on read across from PETMP, PETMA is assumed to be harmful if swallowed (LD50 = 1500 mg/kg bw) and non-toxic if inhaled (no mortality at highest attainable concentration). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a74595e9-0763-4ded-bb37-b88cec9017e2/documents/0eebf97c-b21c-4e6d-aff8-2012b60b8a03_a6e02010-3d24-4cf0-8f0b-ed7ff57052fb.html,,,,,, "2,2-bis[[(mercaptoacetyl)oxy]methyl]-1,3-propanediyl bis(mercaptoacetate)",10193-99-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a74595e9-0763-4ded-bb37-b88cec9017e2/documents/0eebf97c-b21c-4e6d-aff8-2012b60b8a03_a6e02010-3d24-4cf0-8f0b-ed7ff57052fb.html,,oral,LD50,"1,500 mg/kg bw",adverse effect observed, "2,2-bis[[(mercaptoacetyl)oxy]methyl]-1,3-propanediyl bis(mercaptoacetate)",10193-99-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a74595e9-0763-4ded-bb37-b88cec9017e2/documents/0eebf97c-b21c-4e6d-aff8-2012b60b8a03_a6e02010-3d24-4cf0-8f0b-ed7ff57052fb.html,,inhalation,LC50,"3,360 mg/m3",no adverse effect observed, "2,2-bis[[3-(dodecylthio)-1-oxopropoxy]methyl]propane-1,3-diyl bis[3-(dodecylthio)propionate]",29598-76-3," A daily oral gavage of NAUGARD® 412S (a constant volume of 5 mL/kg bw) administeredat the dose levels of 15, 60, 250 and 1000mg/kg bw/day to Crl:WI Wistar ratson a 7 days/week basis for at least 28 days with a 14-day recovery period produced test item-related findings in the liver at 250 and 1000 mg/kg bw/day, and kidney at 1000 mg/kg bw/day.The relationship to dose was reported. The NOAEL for Systemic toxicity for the adults was considered to be 60 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5228a7fb-374e-4a2b-8612-5d3b23b1549a/documents/1d39b322-596a-473a-b66a-4f51278b61b1_2075790b-e53e-427e-9f57-7a2b9633a309.html,,,,,, "2,2-bis[[3-(dodecylthio)-1-oxopropoxy]methyl]propane-1,3-diyl bis[3-(dodecylthio)propionate]",29598-76-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5228a7fb-374e-4a2b-8612-5d3b23b1549a/documents/1d39b322-596a-473a-b66a-4f51278b61b1_2075790b-e53e-427e-9f57-7a2b9633a309.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat "2,2-bis[[3-(dodecylthio)-1-oxopropoxy]methyl]propane-1,3-diyl bis[3-(dodecylthio)propionate]",29598-76-3, Acute Oral Toxicity: LD50 >2000 mg/kg bw (female Wistar rats) Acute Dermal Toxicity: LD50 >2000 mg/kg bw (male/female Crl:WI Wistar rats) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5228a7fb-374e-4a2b-8612-5d3b23b1549a/documents/IUC5-106aa862-d687-4af5-9c1e-3c08d94a296f_2075790b-e53e-427e-9f57-7a2b9633a309.html,,,,,, "2,2-bis[[3-(dodecylthio)-1-oxopropoxy]methyl]propane-1,3-diyl bis[3-(dodecylthio)propionate]",29598-76-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5228a7fb-374e-4a2b-8612-5d3b23b1549a/documents/IUC5-106aa862-d687-4af5-9c1e-3c08d94a296f_2075790b-e53e-427e-9f57-7a2b9633a309.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,2-bis[[3-(dodecylthio)-1-oxopropoxy]methyl]propane-1,3-diyl bis[3-(dodecylthio)propionate]",29598-76-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5228a7fb-374e-4a2b-8612-5d3b23b1549a/documents/IUC5-106aa862-d687-4af5-9c1e-3c08d94a296f_2075790b-e53e-427e-9f57-7a2b9633a309.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2-di(tetrahydrofuryl)propane",89686-69-1," Data for repeated dose toxicity are available from a 28-day oral toxicity study in rats performed according to OECD and EU guidelines as well as GLP principles. Based on this study, a NOAEL of 50 mg/kg bw/d was established based on effects on liver in rats at 150 mg/kg bw/day and higher. As supporting information, the results of a screening study performed according to OECD guideline 421 are included as well. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a8a16fb-988e-4e8f-8fe2-8daa7bf7a157/documents/IUC5-60d2c0f0-6148-45a6-b435-cce960c5c70e_a7ec26b7-aa72-4bab-b021-ba1d99186be2.html,,,,,, "2,2-di(tetrahydrofuryl)propane",89686-69-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a8a16fb-988e-4e8f-8fe2-8daa7bf7a157/documents/IUC5-60d2c0f0-6148-45a6-b435-cce960c5c70e_a7ec26b7-aa72-4bab-b021-ba1d99186be2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "2,2-di(tetrahydrofuryl)propane",89686-69-1," Studies for acute oral and acute dermal toxicity are available, performed according to OECD and GLP guidelines. - The oral LD50 value of Ditetrahydrofurylpropane in Wistar rats was established to be between 300 and 2000 mg/kg body weight; - The dermal LD50 of Ditetrahydrofurylpropane in Wistar rats was established to exceed 2000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a8a16fb-988e-4e8f-8fe2-8daa7bf7a157/documents/IUC5-664d73f9-271f-4eac-bb16-00e1ca066748_a7ec26b7-aa72-4bab-b021-ba1d99186be2.html,,,,,, "2,2-di(tetrahydrofuryl)propane",89686-69-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a8a16fb-988e-4e8f-8fe2-8daa7bf7a157/documents/IUC5-664d73f9-271f-4eac-bb16-00e1ca066748_a7ec26b7-aa72-4bab-b021-ba1d99186be2.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "2,2'-dibromobiphenyl",13029-09-9, OECD 423: LD50 > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/482e2343-f1fe-44fd-b955-74ad7e6d8c49/documents/846159e8-23ee-417f-a475-0f1b9d6e17b0_866a7301-0445-4cf0-8c77-bb2b2d313823.html,,,,,, "2,2'-dibromobiphenyl",13029-09-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/482e2343-f1fe-44fd-b955-74ad7e6d8c49/documents/846159e8-23ee-417f-a475-0f1b9d6e17b0_866a7301-0445-4cf0-8c77-bb2b2d313823.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,2-dichloro-1,1,1-trifluoroethane",306-83-2,Several repeated inhalation toxicity studies were carried out ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b389f83d-9de0-4834-9a13-bf15eb0b06c7/documents/IUC5-21e9b367-b77e-452e-b417-5a4ba00fc557_92f5a1ce-e938-4149-8b16-c87286a551f6.html,,,,,, "2,2-Difluoroethyl Acetate",1550-44-3,"Repeated dose toxicity via oral route – 28-day study: the NOAEL of 2,2-Difluoroethyl acetate was undetermined (< 100 mg/kg/day) for male and female rats based on clinical pathology findings (decreases in leukocyte counts, decreased blood glucose, and increased urine ketones) and nasal lesions observed at all dose levels. Repeated dose toxicity via inhalation route – 28-day study: the NOAEC of 2,2-Difluoroethyl acetate was undetermined (<100 ppm) for male and female rats, based on clinical pathology findings (decreased blood glucose and ketonuria) observed at all exposure levels, and microscopic changes in the nose of male rats in all exposed groups and female rats in the 750 and 1500 ppm groups. Repeated dose toxicity via inhalation route – 90-day study: the NOAEC of 2,2-Difluoroethyl acetate was 10 ppm for male and female rats, based on clinical pathology findings (decreased blood glucose and ketonuria) observed in both sexes at exposure concentration of 100 ppm and adverse and unrecoverable body weight reduction in females exposed at 100 ppm. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): A GPL-compliant study performed according to OECD test guideline 412 is available. It is considered as fully reliable (Klimisch score of 1) and the result is retained as key data. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): A GPL-compliant study performed according to OECD test guideline 413 is available. It is considered as fully reliable (Klimisch score of 1) and the result is retained as key data. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A GPL-compliant study performed according to OECD test guideline 407 is available. It is considered as fully reliable (Klimisch score of 1) and the result is retained as key data. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48cd556e-d941-4132-87aa-fa5f891a1b15/documents/34d78b2b-f784-4f3a-ae0b-3bcc3450657a_e401b259-dc53-40c7-a124-224b2db3ef0f.html,,,,,, "2,2-Difluoroethyl Acetate",1550-44-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48cd556e-d941-4132-87aa-fa5f891a1b15/documents/34d78b2b-f784-4f3a-ae0b-3bcc3450657a_e401b259-dc53-40c7-a124-224b2db3ef0f.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,10 ,, "2,2-Difluoroethyl Acetate",1550-44-3,"Acute oral toxicity: The LD50 of 2,2-Difluoroethyl acetate was greater than 5000 mg/kg bw in female rats. Acute inhalation toxicity: The LC50 of 2,2-Difluoroethyl acetate was greater than 5600 ppm (i.e. greater than 28 mg/L) in male and female rats. Acute dermal toxicity: The LD50 of 2,2-Difluoroethyl acetate was greater than 5000 mg/kg bw in male and female rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): A GPL-compliant study performed according to OECD test guideline 425 (Up-and-Down Procedure) is available. It is considered as fully reliable (Klimisch score of 1) and the result is retained as key data. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): A GPL-compliant study performed according to OECD test guideline 403 is available. It is considered as fully reliable (Klimisch score of 1) and the result is retained as key data. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): A GPL-compliant study performed according to OECD test guideline 402 is available. It is considered as fully reliable (Klimisch score of 1) and the result is retained as key data. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48cd556e-d941-4132-87aa-fa5f891a1b15/documents/d117b4f4-49f8-4efb-8a7c-568214396f49_e401b259-dc53-40c7-a124-224b2db3ef0f.html,,,,,, "2,2-Difluoroethyl Acetate",1550-44-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48cd556e-d941-4132-87aa-fa5f891a1b15/documents/d117b4f4-49f8-4efb-8a7c-568214396f49_e401b259-dc53-40c7-a124-224b2db3ef0f.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "2,2-Difluoroethyl Acetate",1550-44-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48cd556e-d941-4132-87aa-fa5f891a1b15/documents/d117b4f4-49f8-4efb-8a7c-568214396f49_e401b259-dc53-40c7-a124-224b2db3ef0f.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "2,2-Difluoroethyl Acetate",1550-44-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48cd556e-d941-4132-87aa-fa5f891a1b15/documents/d117b4f4-49f8-4efb-8a7c-568214396f49_e401b259-dc53-40c7-a124-224b2db3ef0f.html,,inhalation,LC50,> 28 mg/L,no adverse effect observed, "2,2-dimethyl-1,3-dioxane-4,6-dione",2033-24-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ceff332a-134c-49e0-8b90-57aa702ed92c/documents/aafe5d0d-81d3-4032-9c66-e085feda1f70_d4ebe9a1-ccca-451d-9c29-cc9cc55f11ec.html,,oral,LD50,"4,000 mg/kg bw",adverse effect observed, "2,2-dimethyl-1,3-propanediyl dioctanoate",31335-74-7,All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a04c5352-c502-4f3c-9765-b06d9d5fe4c2/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_6963fd1c-8717-4625-bd26-34c5d27b2d71.html,,,,,, "2,2-dimethyl-1,3-propanediyl dioctanoate",31335-74-7,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a04c5352-c502-4f3c-9765-b06d9d5fe4c2/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_6963fd1c-8717-4625-bd26-34c5d27b2d71.html,,,,,, "2,2-dimethyl-1,3-propanediyl dioleate",42222-50-4,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category. All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1921a482-f366-4537-a5ef-01ed4568bb34/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_14a37455-efc0-468a-b9fd-7765b2a5f916.html,,,,,, "2,2-dimethyl-1,3-propanediyl dioleate",42222-50-4,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1921a482-f366-4537-a5ef-01ed4568bb34/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_14a37455-efc0-468a-b9fd-7765b2a5f916.html,,,,,, "2,2'-dimethyl-2,2'-azodipropiononitrile",78-67-1,"The repeat dose toxicity of 2,2'-Azobis(2 -methylpropionitrile) was evaluated in a 90 days repeated dose toxicity study performed according to OECD 408. The NOAEL in the study was set at 10 mg/kg/day. The repeat dose toxicity of 2,2'-Azobis(2 -methylpropionitrile) was evaluated in a combined reproductive / developmental screening study following OECD 422 guideline. NOEL for repeat toxicity was suggested to be less than 2 mg/kg/day in males and 2 mg/kg in females. Subchronic toxicity study OECD 408 (P. Harvey, 2014) 2,2’-Azobis(2-methylpropionitrile) daily administration of AZDN for 13 weeks at dose levels of 0.5, 2 or 10 mg/kg/day was well tolerated. There was no evidence of neurotoxicity. There were slight changes in some blood clinical chemistry and urine parameters at all dose levels. The liver and kidney were identified as target organs based on increased weights (at all dose levels in males) and microscopic findings of hepatocyte hypertrophy (at all dose levels in males and at =2 mg/kg/day in females) and focal nephropathy/tubular basophilia and hyaline droplets in males at all dose levels. Hyaline droplets appear as eosinophilic cytoplasmic inclusions in the proximal tubular epithelial cells and are a common background finding in the kidney of male rats. Hyaline droplets are generally considered to represent accumulations of alpha 2u globulin, a naturally occurring male rat protein, and this was confirmed by immunohistochemical staining in this study. The liver hypertrophy is considered an adaptive change commonly associated with metabolic burden and the changes in the kidney are considered specific to the male rat. The minor changes in urinalysis parameters are considered to reflect these changes in the kidney, and thus are of little relevance. Similarly, the blood clinical chemistry are considered not to be of toxicological relevance.   The nature of these histopathological changes were therefore considered to be of no toxicological relevance and the No-Observed-Adverse-Effect-Level (NOAEL) is considered to be 10 mg/kg/day.     Combined repeated dose toxicity study (OECD 422) (Hatano, 1999) 2,2’-Azobis(2-methylpropionitrile) was orally administered to male and female Sprague-Dawley (Crj:CD) rats, 13 males and 13 females per group, at 0 (vehicle control), 2, 10 and 50 mg/kg bw for 2 weeks before mating and for 2 weeks after mating, followed by additional 2 weeks after completion of mating in males and throughout the gestation period until Day 3 of lactation after parturition in females, in order to evaluate the repeated dose toxicity and effects of the test item on the reproductive performance in parental animals and development and growth of the next-generation animals.    The treatment with the test item inhibited weight gain and feed consumption in both males and females at 50 mg/kg bw. These changes were thought to be attributable to the treatment since similar changes were observed in the 50 mg/kg group in a preliminary 14-day repeated dose toxicity study. Weight gain was also inhibited at 10 mg/kg in females, suggesting the presence of gender differences. Observation of general signs and symptoms during the treatment period revealed scattered incidence of salivation immediately after administration in the 10 mg/kg and higher dose groups. Because a prompt recovery was noted in all cases, this change was thought to be not attributable any toxic potential effect. Necropsy revealed increases in weight of the liver in the 10 mg/kg and higher dose groups in males and in the 50 mg/kg group in females. Histopathological examinations showed centrilobular hypertrophy of hepatocytes in the 10 mg/kg and higher dose groups in both males and females. This change was thought to reflect increases in hepatic function induced by AZDN dosing because it is anticipated to be transferred to the liver after entering the body and therefore this change would represent an adaptative response of the liver.. Blood biochemical examinations in the present study showed increases in total protein, albumin, and total cholesterol in males from the 50 mg/kg group. Increases in Ca concentrations observed in the 50 mg/kg group were thought to be associated with increases in albumin. Because the A/G ratio decreased in this group, blood globulin concentrations were also thought to have increased. In necropsy, weight of the kidneys showed a tendency to increase in males from the 2 mg/kg or higher dose groups and females from the 50 mg/kg group. Histopathological examinations revealed increases in eosinophilic bodies and regenerative renal tubules in males from the 2 mg/kg or greater dose groups. Both changes may spontaneously occur in males. However, their incidence and severity were apparently different from those seen in the control group. Granular casts containing necrotic cells were also observed. Coupled with the fact that inorganic P concentrations increased and Cl concentrations decreased in males from the 50 mg/kg group,these findings suggest that AZDN has effects on the kidneys, however considering the fact that only males were observed with renal changes, it is assumed that alpha-2 -macroglobulin is involved in this specific toxicity. . Increases in platelets observed in hematological examinations in males from the 50 mg/kg group were thought to be attributable to AZDN because similar effects were seen in the 50 mg/kg group in the preliminary study, but the toxicological significance of this change could not be clarified in the present study.    ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51d6c948-7898-446b-8a86-72ae8c088679/documents/IUC5-5042dc27-56b9-4aa3-b058-cccdebe9e1b4_70ae8979-8802-4d9a-8a7d-a6ddbacb96db.html,,,,,, "2,2'-dimethyl-2,2'-azodipropiononitrile",78-67-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51d6c948-7898-446b-8a86-72ae8c088679/documents/IUC5-5042dc27-56b9-4aa3-b058-cccdebe9e1b4_70ae8979-8802-4d9a-8a7d-a6ddbacb96db.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "2,2'-dimethyl-2,2'-azodipropiononitrile",78-67-1,"Acute oral : the oral LD50 of AZDN was comprised between 300 and 2000 mg/kg in rats (GLP guideline study, OECD 423).Acute inhalation : No reliable study (data waiving).Acute dermal : the dermal LD50 of the test item AZDN was higher than 2000 mg/kg in rats (GLP guideline study, OECD 402). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51d6c948-7898-446b-8a86-72ae8c088679/documents/IUC5-db074c3b-58b1-491a-bca4-809a5203c61f_70ae8979-8802-4d9a-8a7d-a6ddbacb96db.html,,,,,, "2,2'-dimethyl-2,2'-azodipropiononitrile",78-67-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51d6c948-7898-446b-8a86-72ae8c088679/documents/IUC5-db074c3b-58b1-491a-bca4-809a5203c61f_70ae8979-8802-4d9a-8a7d-a6ddbacb96db.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, "2,2'-dimethyl-2,2'-azodipropiononitrile",78-67-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51d6c948-7898-446b-8a86-72ae8c088679/documents/IUC5-db074c3b-58b1-491a-bca4-809a5203c61f_70ae8979-8802-4d9a-8a7d-a6ddbacb96db.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)",6864-37-5," oral For the oral route, several studies are available. The most import and most reliable studies are an OECD TG 408 and an OECD TG 443, which are used in an weight of evidence approach: In the 90-day (gavage) study with rats (OECD TG 408 and GLP) dose levels of 2.5, 12 and 60 mg/kg bw/day were administered resulting in a NOAEL of 2.5 mg/kg bw/day. The 3-month administration of the test item to male and female rats at a dose of 60 mg/kg bw/day each working day by gavage led to clear toxic findings, such as reduced feed consumption, retarded body weight gain, impaired general state of health, changes of the hematologic (white and red blood counts), enzymatic, clinicochemical and urinanalytical parameters as well as hepato-and nephrotoxic, myocardially toxic and adrenotoxic (progressive transformation) effects. A dose of 12 mg/kg bw/day led in the female animals to a reduced feed consumption, in the animals of both sexes to a retarded body weight gain, and to an increase of the aspartate aminotransferase values in the male animals. Urinalysis detected in both sexes an increased number of bacteria, of round-cell epithelia with and without nucleus, and of renal epithelia and in the male animals an increase of erythrocytes. The pathological examinations exhibited hepato and nephrotoxic and myocardially toxic findings. The dose group of 2.5 mg/kg bw/day caused no differences when compared with the control and was defined as NOAEL. [BASF AG, 1990] Furthermore, DMDC was administered in an EOGRTS (OECD TG 443 and GLP) to groups of 25 male and 25 female healthy young Wistar rats as test groups 00 - 03 as an aqueous preparation by stomach tube at different dosages (0, 1.5, 5 and 15 mg/kg body weight/day [mg/kg bw/d]). F0 animals were treated at least for 10 weeks prior to mating to produce a litter (F1 generation). Control animals were dosed daily with the vehicle (0.5% Sodium carboxymethyl cellulose [CMC] suspension in drinking water). Under the conditions of the present extended 1-generation reproduction toxicity study the NOAEL for general, systemic toxicity is the low dose of 1.5 mg/kg bw/d for the F0 animals. This was based on treatment-related, adverse effects such as a reduction in water and food consumption, decrease in body weight (change), altered clinical pathology parameters as well as histopathological changes in several organs, which were observed at the high- and mid-dose of 15 and 5 mg/kg bw/d. [BASF SE, 2020]. Inhalation For the inhalation route, a 90-day study with rats (OECD TG 413 and GLP) was performed with concentrations of 2, 12 and 48 mg/m3. The NOAEC was 12 mg/m3 for local and systemic effects. Repeated inhalation of the test item showed systemic toxicity in the target organs liver and spleen in the form of hepatotoxicity and a disturbed hemoglobin metabolism. The amine-specific local toxicity was manifest in the form of changes in the target organs skin and nasal mucosa and led to hyperkeratosis or to a degeneration of the olfactory epithelium. [BASF AG, 1992] ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/425b11b2-8613-4ec1-82bf-e523738f4b95/documents/IUC5-8e517333-f0fc-479a-9300-27070ffd621e_f7363517-c210-40a1-9c47-e3d38c779a53.html,,,,,, "2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)",6864-37-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/425b11b2-8613-4ec1-82bf-e523738f4b95/documents/IUC5-8e517333-f0fc-479a-9300-27070ffd621e_f7363517-c210-40a1-9c47-e3d38c779a53.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,1.5 mg/kg bw/day,,rat "2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)",6864-37-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/425b11b2-8613-4ec1-82bf-e523738f4b95/documents/IUC5-8e517333-f0fc-479a-9300-27070ffd621e_f7363517-c210-40a1-9c47-e3d38c779a53.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,12 mg/m3,,rat "2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)",6864-37-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/425b11b2-8613-4ec1-82bf-e523738f4b95/documents/IUC5-8e517333-f0fc-479a-9300-27070ffd621e_f7363517-c210-40a1-9c47-e3d38c779a53.html,Repeated dose toxicity – local effects,inhalation,NOAEC,12 mg/m3,adverse effect observed,rat "2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)",6864-37-5," The acute oral, dermal and inhalation toxicity was investigated in studies performed comparable to the relevant guidelines, resulting in an oral LD50 of 320-460 mg/kg bw, a dermal LD50 of 200-400 mg/kg bw and an inhalation LC50 of 420 mg/m3. Thus, the substance is harmful to health via the oral route and toxic via the dermal and inhalation route. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/425b11b2-8613-4ec1-82bf-e523738f4b95/documents/IUC5-d96b4fa0-1956-40f0-8d00-d5a014d50d5d_f7363517-c210-40a1-9c47-e3d38c779a53.html,,,,,, "2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)",6864-37-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/425b11b2-8613-4ec1-82bf-e523738f4b95/documents/IUC5-d96b4fa0-1956-40f0-8d00-d5a014d50d5d_f7363517-c210-40a1-9c47-e3d38c779a53.html,,oral,LD50,320 mg/kg bw,adverse effect observed, "2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)",6864-37-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/425b11b2-8613-4ec1-82bf-e523738f4b95/documents/IUC5-d96b4fa0-1956-40f0-8d00-d5a014d50d5d_f7363517-c210-40a1-9c47-e3d38c779a53.html,,dermal,LD50,200 mg/kg bw,adverse effect observed, "2,2'-dimethyl-4,4'-methylenebis(cyclohexylamine)",6864-37-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/425b11b2-8613-4ec1-82bf-e523738f4b95/documents/IUC5-d96b4fa0-1956-40f0-8d00-d5a014d50d5d_f7363517-c210-40a1-9c47-e3d38c779a53.html,,inhalation,LC50,420 mg/m3,adverse effect observed, "2,2-dimethylbutane",75-83-2, Acute toxicity oral LD50 >16750 mg/kg in rats (OECD TG 401) Acute toxicity inhalation LC50 >259354 mg/m3 in rats (OECD TG 403) Acute toxicity dermal LD50 >3350 mg/kg in rabbits (OECD TG 402) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8bde88f-9d23-4b48-b367-3b13d81967ad/documents/4d09f91b-cbb1-4b96-80ff-c028ecb5f11d_ca598f65-eb3c-4fa5-b635-7f723100fe6f.html,,,,,, "2,2-dimethylbutane",75-83-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8bde88f-9d23-4b48-b367-3b13d81967ad/documents/4d09f91b-cbb1-4b96-80ff-c028ecb5f11d_ca598f65-eb3c-4fa5-b635-7f723100fe6f.html,,oral,LD50,"> 16,750 mg/kg bw",no adverse effect observed, "2,2-dimethylbutane",75-83-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8bde88f-9d23-4b48-b367-3b13d81967ad/documents/4d09f91b-cbb1-4b96-80ff-c028ecb5f11d_ca598f65-eb3c-4fa5-b635-7f723100fe6f.html,,dermal,LD50,"> 3,350 mg/kg bw",no adverse effect observed, "2,2-dimethylbutane",75-83-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8bde88f-9d23-4b48-b367-3b13d81967ad/documents/4d09f91b-cbb1-4b96-80ff-c028ecb5f11d_ca598f65-eb3c-4fa5-b635-7f723100fe6f.html,,inhalation,LC50,"> 259,354 mg/m3",no adverse effect observed, "2,2-dimethyloxirane",558-30-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc3e8df3-509a-4f37-92bc-5af2b14d073f/documents/IUC5-a186d3c6-275b-44ba-98e3-c5f0c45b91e7_c484ab6b-08dd-4aa6-8b19-dc19949e7300.html,,oral,LD50,"3,890 mg/kg bw",, "2,2-dimethylpropane-1,3-diamine",7328-91-8," LD50 (oral, rat): 1020 mg/kg bw LD50 (dermal, rat): >1000 < 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/844c66a0-6fa5-4ef4-b4d5-94220133f51e/documents/eb540710-ac90-4f66-bf5f-b4600cec5ef2_e5b2db46-8a63-4413-a603-ceca4f9f0d6b.html,,,,,, "2,2-dimethylpropane-1,3-diamine",7328-91-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/844c66a0-6fa5-4ef4-b4d5-94220133f51e/documents/eb540710-ac90-4f66-bf5f-b4600cec5ef2_e5b2db46-8a63-4413-a603-ceca4f9f0d6b.html,,oral,LD50,"1,020 mg/kg bw",adverse effect observed, "2,2-dimethylpropane-1,3-diyl cyclohex-4-ene-1,2-dicarboxylate",41026-17-9," A Subchronic oral toxicity study was designed to investigate the systemic toxicity of the test item and is compatible with the following regulatory guidelines: ·        The OECD Guidelines for Testing of Chemicals No. 408 ""Subchronic Oral Toxicity - Rodent: 90 Day Study” (Adopted 21 September 1998). This study was also designed to be compatible with Commission Regulation (EC) No 440/2008 of 30 May 2008, laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).The No Observed Adverse Effect Level (NOAEL) for 2,2-dimethylpropane-1,3-diyl cyclohex-4-ene-1,2-dicarboxylate over a ninety-day treatment period was considered to be 100 mg/kg bw/day, due to adverse histopathological kidney changes for both sexes at the high dosage of 750 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34d76ccd-f02a-47cb-8cff-8722f2717879/documents/IUC5-d79aa7ff-b171-4892-8009-fc3623ab2253_98eb170a-4c52-4616-8381-251d35b5847a.html,,,,,, "2,2-dimethylpropane-1,3-diyl cyclohex-4-ene-1,2-dicarboxylate",41026-17-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34d76ccd-f02a-47cb-8cff-8722f2717879/documents/IUC5-d79aa7ff-b171-4892-8009-fc3623ab2253_98eb170a-4c52-4616-8381-251d35b5847a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2,2-dimethylpropane-1,3-diyl cyclohex-4-ene-1,2-dicarboxylate",41026-17-9,"1,2,3,6-tetrahydrophthalic anhydride, oligomeric reaction products with 2,2-dimethylpropan-1,3-diol used as read-across chemical was tested for acute toxicity in an OECD 425 acute oral toxicity in rats and in a OECD 422 acute dermal toxicity in rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34d76ccd-f02a-47cb-8cff-8722f2717879/documents/IUC5-92108a43-11b6-4c81-bd15-9120c97d91f7_98eb170a-4c52-4616-8381-251d35b5847a.html,,,,,, "2,2-dimethylpropane-1,3-diyl dibenzoate",4196-89-8, There is no subchronic study available. In the subacute oral study in rats no relevant hazard was identified resulting in a NOAEL of 1000 mg/kg bw/day. It is assumed that prolongation of treatment time does not provide additional information on toxic effects. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edf877ed-9b4b-4a11-81a2-d79263d5f814/documents/IUC5-ee90bd8c-94ea-46d4-aa98-fa9e640bda64_2a892e02-3215-4c41-bcb2-c73ea3d9846e.html,,,,,, "2,2-dimethylpropane-1,3-diyl dibenzoate",4196-89-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edf877ed-9b4b-4a11-81a2-d79263d5f814/documents/IUC5-ee90bd8c-94ea-46d4-aa98-fa9e640bda64_2a892e02-3215-4c41-bcb2-c73ea3d9846e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2-dimethylpropane-1,3-diyl dibenzoate",4196-89-8," There are acute toxicity studies available using different application routes. Thus, the conditions according to Regulation (EC) 1907/2006 (REACH) ANNEX VIII, section 8.5 column 2 are fulfilled. The results of these studies show that 2,2-dimethylpropane-1,3-diyl dibenzoate is practically non-toxic. LD50 (oral, dermal) > 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edf877ed-9b4b-4a11-81a2-d79263d5f814/documents/IUC5-f0ec6d12-a293-49c0-b3f7-2a32459cc0ce_2a892e02-3215-4c41-bcb2-c73ea3d9846e.html,,,,,, "2,2-dimethylpropane-1,3-diyl dibenzoate",4196-89-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edf877ed-9b4b-4a11-81a2-d79263d5f814/documents/IUC5-f0ec6d12-a293-49c0-b3f7-2a32459cc0ce_2a892e02-3215-4c41-bcb2-c73ea3d9846e.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2,2-dimethylpropane-1,3-diyl dibenzoate",4196-89-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edf877ed-9b4b-4a11-81a2-d79263d5f814/documents/IUC5-f0ec6d12-a293-49c0-b3f7-2a32459cc0ce_2a892e02-3215-4c41-bcb2-c73ea3d9846e.html,,dermal,discriminating dose,"20,000 mg/kg bw",no adverse effect observed, "2,2-dimethylthiazolidine",19351-18-9," Acute oral toxicity, female/male mice, oral gavage, doses: 0, 480, 595, 738, 915, 1135, 1407, 1745 and 2164 mg/kg bw; Japanese Report and translated summary are available.   LD50 703.59 mg/kg bw in female mice and 798.97 mg/kg bw in male mice;   Mortality was observed from 30 minutes after the administration until two days afterwards. For males, mortality occured in the 595 mg/kg and higher dose groups; at doses ≥ 1135 mg/kg all males died. For females, mortality occured in the 595 mg/kg and higher dose groups; at doses ≥ 915 mg/kg, all females died.   Acute dermal toxicity: no study available Acute inhalation toxicity: no study available ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6660d111-7928-460a-b7b5-8c6e24be1c37/documents/80bc659e-4a11-43c3-9039-2a47a9a5f2bc_084037d9-d6ba-4bcc-b0a8-00daeadc16df.html,,,,,, "2,2-dimethylthiazolidine",19351-18-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6660d111-7928-460a-b7b5-8c6e24be1c37/documents/80bc659e-4a11-43c3-9039-2a47a9a5f2bc_084037d9-d6ba-4bcc-b0a8-00daeadc16df.html,,oral,LD50,703.59 mg/kg bw,adverse effect observed, "2,2'-dimorpholinyldiethyl ether",6425-39-4,"Repeated dose toxicity: oral: No adverse effects were observed in male and female Wistar rats in a combined repeated dose/reprotox study conducted according to OECD Guideline 422 (Martell, 2013). Under the experimental conditions of this study, the NOAEL of the test substance in Wistar rats was 300 mg/kg/day for males and females. This study was selected as key study.In addition, no adverse effects were observed in male and female Crj:CD(SD) rats in a 28 days repeated dose test conducted according to OECD 407. The NOAEL in this study was derived to be 150 mg/kg bw/d for both males and females, based on the toxicological effects at the 600 mg/kg dose.Repeated dose toxicity: dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure .Repeated dose toxicity: inhalation: No study with the target substance is available. Data from supporting substance morpholine is used to cover this endpoint. In a two-year chronic inhalation study, performed according to a method equivalent to OECD Guideline 452 (HAZLETON INC, 1983), rats exposed by inhalation to the read-across substance morpholine at concentrations of 0, 36, 181 or 543 mg/m³, 6 hours/day, 5 days/week for 104 weeks showed normal growth, survival and haematology and clinical chemistry parameters. A systemic intoxication was not observed. At the highest dose, chronic nasal irritation and some ocular injury was observed. Owing to its corrosivity, morpholine exposure resulted in irritation and inflammation of the upper digestive tract on oral intake, irritation of the respiratory tract and eyes following inhalation and, in high concentrations, irritation on contact with the skin. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2bd9ffb9-be56-413d-af71-c550d280fa10/documents/IUC5-ae77c4c4-6068-46c9-9368-636e0b62e19f_37fb0e5f-4c26-47c7-8e9d-662168d3b20b.html,,,,,, "2,2'-dimorpholinyldiethyl ether",6425-39-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2bd9ffb9-be56-413d-af71-c550d280fa10/documents/IUC5-ae77c4c4-6068-46c9-9368-636e0b62e19f_37fb0e5f-4c26-47c7-8e9d-662168d3b20b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2,2'-dimorpholinyldiethyl ether",6425-39-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2bd9ffb9-be56-413d-af71-c550d280fa10/documents/IUC5-ae77c4c4-6068-46c9-9368-636e0b62e19f_37fb0e5f-4c26-47c7-8e9d-662168d3b20b.html,Chronic toxicity – systemic effects,inhalation,NOAEC,181 mg/m3,,rat "2,2'-dimorpholinyldiethyl ether",6425-39-4,"Acute toxicity: oral:A K2 acute oral toxicity test was performed in male and female Crl:COBS CD(SD)BR rats according to a guideline similar to OECD Guideline 401 (Huntsman, 1978). This study was selected as key study. Acute toxicity: inhalationNo reliable acute inhalation test was available for DMDEE. Only a K4 study is available for acute inhalation tested in male and female Sprague Dawley rats (Huntsman, 1978). The test was performed according a guideline equivalent to OECD Guideline 403.Acute toxicity: dermalA K2 acute dermal test was performed in male and female New Zealand White rabbits according to a guideline similar to OECD Guideline 402 (Huntsman, 1978). This study was selected as key study. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bd9ffb9-be56-413d-af71-c550d280fa10/documents/IUC5-a46ac504-2139-4d41-9760-dacbbbdafdf6_37fb0e5f-4c26-47c7-8e9d-662168d3b20b.html,,,,,, "2,2'-dimorpholinyldiethyl ether",6425-39-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bd9ffb9-be56-413d-af71-c550d280fa10/documents/IUC5-a46ac504-2139-4d41-9760-dacbbbdafdf6_37fb0e5f-4c26-47c7-8e9d-662168d3b20b.html,,oral,LD50,"2,025 mg/kg bw",adverse effect observed, "2,2'-dimorpholinyldiethyl ether",6425-39-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bd9ffb9-be56-413d-af71-c550d280fa10/documents/IUC5-a46ac504-2139-4d41-9760-dacbbbdafdf6_37fb0e5f-4c26-47c7-8e9d-662168d3b20b.html,,dermal,LD50,"3,038 mg/kg bw",adverse effect observed, "2,2-dioctyl-1,3,2-oxathiastannolan-5-one",15535-79-2," Since the target substance DOTTG is only manufactured in situ with DOTE and marketed typically as 2 -3 % solutions (max 10 %) The evaluation of the repeated dose toxicity was based on three studies on the source substance DOTE supported by data on the structural analgue DOTI DOTE has been classified and harmonized as toxic for reproduction of category 1B (H360d) and the RAC (RAC 47, November 2018) has recently come to the opinion Aquatic Acute 1 (H400), Aquatic Chronic 1 (H410) and STOT RE 1 (H372) should be added to the Annex VI CLP. The manufactures self-classify DOTE as Skin Sens. 1A (H317). Furthermore DOTE has been prioritized for inclusion into Annex XIV Since DOTTG is only manufactured in low concentrations in DOTE the exposure of humans and environment towards DOTTG will only be possible in conjunction with a significantly higher exposure towards DOTE.   Since DOTE is already classified in the highest hazard categories it appears to be inappropriate to conduct additional animal studies on DOTTG. These studies would be incompatible with ethical standards since results of the requested studies would not be able to change the classification of stabilizers containing DOTTG as minor constituent.    Any further regulatory fate of DOTTG, such as possible authorization / restriction, is closely linked to DOTE. Since DOTTG is only manufactured and marketed as a minor constituent of DOTE further use of DOTTG is linked to the authorization of DOTE in authorized applications - Two subchronic oral toxicity tests (rat) with mixtures containing a high concentration of DOT(2 -EHMA) (70 and 97% purity)- no guideline studies; - One subchronic toxicity test (dog) with Dioctylin bis (IOMA) and dioctyltin bis (2-EHMA) which are isomers of the same compound and are structural analogues of each other. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/7246bbb1-e0d1-4189-8b7a-463afe9ca9fc/documents/c2fe807e-c6b2-4589-afb8-71ed8b8b14eb_25555a4a-3de3-4e62-8cc6-bd2b737e18b3.html,,,,,, "2,2-dioctyl-1,3,2-oxathiastannolan-5-one",15535-79-2,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/7246bbb1-e0d1-4189-8b7a-463afe9ca9fc/documents/c2fe807e-c6b2-4589-afb8-71ed8b8b14eb_25555a4a-3de3-4e62-8cc6-bd2b737e18b3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.5 mg/kg bw/day,,rat "2,2-dioctyl-1,3,2-oxathiastannolan-5-one",15535-79-2,"ORALDiscriminating dose = 300 mg/kg bw, female rat, OECD 420, EU Method B.1 bis, Sanders (2013a).DERMALLD50 > 2000 mg/kg bw (dioctyltin oxide), male/female rat, OECD 402, EU Method B.3, Sanders (2012a). ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7246bbb1-e0d1-4189-8b7a-463afe9ca9fc/documents/IUC5-cf8927d2-b210-434d-8f63-6e7eebdc7e0e_25555a4a-3de3-4e62-8cc6-bd2b737e18b3.html,,,,,, "2,2-dioctyl-1,3,2-oxathiastannolan-5-one",15535-79-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7246bbb1-e0d1-4189-8b7a-463afe9ca9fc/documents/IUC5-cf8927d2-b210-434d-8f63-6e7eebdc7e0e_25555a4a-3de3-4e62-8cc6-bd2b737e18b3.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, "2,2'-ethylenedioxydiethyl bis(2-ethylhexanoate)",94-28-0,"The key study for oral repeated dose toxicity is an oral 90-day repeated dose toxicity study in the rat (Grosz, 2013). The resultant NOAEL (oral) is 120 mg/kg bw/day based on females. The key study for inhalation repeated dose toxicity study is a 2-week inhalation toxicity study in the rat (Dupont, 2005). The resultant NOAEL (inhalation) is > 1000 mg/m3. The information available is very recent and of good quality, so the overall quality of the database is considered good. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9dab6e2f-38af-4974-831d-f6d70c2f0df5/documents/0a65129a-03aa-4414-b487-546b711d1db6_ca13f56e-8626-46f8-b131-579f8bc1d066.html,,,,,, "2,2'-ethylenedioxydiethyl bis(2-ethylhexanoate)",94-28-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9dab6e2f-38af-4974-831d-f6d70c2f0df5/documents/0a65129a-03aa-4414-b487-546b711d1db6_ca13f56e-8626-46f8-b131-579f8bc1d066.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat "2,2'-ethylenedioxydiethyl bis(2-ethylhexanoate)",94-28-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9dab6e2f-38af-4974-831d-f6d70c2f0df5/documents/0a65129a-03aa-4414-b487-546b711d1db6_ca13f56e-8626-46f8-b131-579f8bc1d066.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat "2,2'-ethylenedioxydiethyl bis(2-ethylhexanoate)",94-28-0,Oral: LD50 > 2000 mg/kg bw for rat (limit test) (OECD 420).Dermal: LD50 > 2000 mg/kg bw for rabbit (limit test) (OECD 402).Inhalation: LC50 > 2000 mg/m³ (limit test) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9dab6e2f-38af-4974-831d-f6d70c2f0df5/documents/0fcd91ed-a63f-4088-9f6f-b7a56f5c0158_ca13f56e-8626-46f8-b131-579f8bc1d066.html,,,,,, "2,2'-iminobis[4,6-diamino-1,3,5-triazine]",3576-88-3,The toxicity of melam is low. The NOEL is 1000 mg/kg bw. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10101460-5952-424a-916f-a6dc41976bb6/documents/IUC5-47713868-3880-430c-9abe-380deabbf58d_6e5219e4-518c-42a5-bce9-9efdc8d77e68.html,,,,,, "2,2'-iminobis[4,6-diamino-1,3,5-triazine]",3576-88-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10101460-5952-424a-916f-a6dc41976bb6/documents/IUC5-47713868-3880-430c-9abe-380deabbf58d_6e5219e4-518c-42a5-bce9-9efdc8d77e68.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2'-iminobis[4,6-diamino-1,3,5-triazine]",3576-88-3,Melam is of low toxicity for each of the exposure routes. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10101460-5952-424a-916f-a6dc41976bb6/documents/IUC5-95055336-2933-45b5-8ce9-2c6699518464_6e5219e4-518c-42a5-bce9-9efdc8d77e68.html,,,,,, "2,2'-iminobis[4,6-diamino-1,3,5-triazine]",3576-88-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10101460-5952-424a-916f-a6dc41976bb6/documents/IUC5-95055336-2933-45b5-8ce9-2c6699518464_6e5219e4-518c-42a5-bce9-9efdc8d77e68.html,,oral,LD50,"5,000 mg/kg bw",, "2,2'-iminobis[4,6-diamino-1,3,5-triazine]",3576-88-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10101460-5952-424a-916f-a6dc41976bb6/documents/IUC5-95055336-2933-45b5-8ce9-2c6699518464_6e5219e4-518c-42a5-bce9-9efdc8d77e68.html,,dermal,LD50,"2,500 mg/kg bw",, "2,2'-iminobis[4,6-diamino-1,3,5-triazine]",3576-88-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10101460-5952-424a-916f-a6dc41976bb6/documents/IUC5-95055336-2933-45b5-8ce9-2c6699518464_6e5219e4-518c-42a5-bce9-9efdc8d77e68.html,,inhalation,LC50,"5,264 mg/m3",, "2,2'-isopropylidenebis(p-phenyleneoxy)diethanol",901-44-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Good; compliant to GLP and testing guidelines; adequate consistence between data, comments and conclusions. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69221a4f-4dfd-48cb-a262-5861628c4694/documents/f642f5ba-c1ef-474b-8bdb-e4239e713a74_e2903b0a-fe1a-41fd-b808-da2cd640897d.html,,,,,, "2,2'-isopropylidenebis(p-phenyleneoxy)diethanol",901-44-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69221a4f-4dfd-48cb-a262-5861628c4694/documents/f642f5ba-c1ef-474b-8bdb-e4239e713a74_e2903b0a-fe1a-41fd-b808-da2cd640897d.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,250 mg/kg bw/day,,rat "2,2'-isopropylidenebis(p-phenyleneoxy)diethanol",901-44-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): two acute oral toxicity studies were available and indicate the low acute toxicity of the substance. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The results of the acute inhalation study are coherent with the physico-chemical properties of the substance. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69221a4f-4dfd-48cb-a262-5861628c4694/documents/a45574e6-c5c3-474d-8777-add2f79f2890_e2903b0a-fe1a-41fd-b808-da2cd640897d.html,,,,,, "2,2'-isopropylidenebis(p-phenyleneoxy)diethanol",901-44-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69221a4f-4dfd-48cb-a262-5861628c4694/documents/a45574e6-c5c3-474d-8777-add2f79f2890_e2903b0a-fe1a-41fd-b808-da2cd640897d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2'-isopropylidenebis(p-phenyleneoxy)diethanol",901-44-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69221a4f-4dfd-48cb-a262-5861628c4694/documents/a45574e6-c5c3-474d-8777-add2f79f2890_e2903b0a-fe1a-41fd-b808-da2cd640897d.html,,inhalation,LC50,21 mg/m3,no adverse effect observed, "2,2'-methylenebis(4,6-di-tert-butyl-phenyl)-2-ethylhexyl phosphite",126050-54-2," 28 day repeated dose oral toxicity study: NOEL 10000 ppm. 90 day repeated dose oral toxicity study: NOEL 5000 ppm. 28 study NOEL is the top dose so NOAEL cannot be established). NOAEL based on 90 day study: 50,000 ppm (as the food consumption increase at this dose level is not an adverse effect ). 50,000 ppm is equivalent to males: at least 2637 mg/kg/day; Females: at least 3205 mg/kg/day. The lowest value will be taken as the NOAEL. Therefore NOAL = 2637 mg/kg/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4aee3eec-e83a-4edd-9eec-a3bd75e854cf/documents/IUC5-8a5dd994-3c99-4200-a25b-ff0aee998477_d839a3d1-f62e-4618-8237-36dcf4575691.html,,,,,, "2,2'-methylenebis(4,6-di-tert-butyl-phenyl)-2-ethylhexyl phosphite",126050-54-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4aee3eec-e83a-4edd-9eec-a3bd75e854cf/documents/IUC5-8a5dd994-3c99-4200-a25b-ff0aee998477_d839a3d1-f62e-4618-8237-36dcf4575691.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,637 mg/kg bw/day",,rat "2,2'-methylenebis(4,6-di-tert-butyl-phenyl)-2-ethylhexyl phosphite",126050-54-2, Acute oral toxicity: LD50 >5000 mg/kg bodyweight male/female rats. Acute dermal toxicity: LD50 >2000 mg/kg bodyweight in male/female rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aee3eec-e83a-4edd-9eec-a3bd75e854cf/documents/IUC5-8f8339b3-9f00-4eb6-8560-a6d679a59677_d839a3d1-f62e-4618-8237-36dcf4575691.html,,,,,, "2,2'-methylenebis(4,6-di-tert-butyl-phenyl)-2-ethylhexyl phosphite",126050-54-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aee3eec-e83a-4edd-9eec-a3bd75e854cf/documents/IUC5-8f8339b3-9f00-4eb6-8560-a6d679a59677_d839a3d1-f62e-4618-8237-36dcf4575691.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,2'-methylenebis(4,6-di-tert-butyl-phenyl)-2-ethylhexyl phosphite",126050-54-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aee3eec-e83a-4edd-9eec-a3bd75e854cf/documents/IUC5-8f8339b3-9f00-4eb6-8560-a6d679a59677_d839a3d1-f62e-4618-8237-36dcf4575691.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2'-methylenebis[6-(1-methylcyclohexyl)-p-cresol]",77-62-3," No Observed Adverse Effect Level (NOAEL) for 2,2’-methylenebis[6-(1-methylcyclohexyl)-p-cresol] was considered to be 1000 mg/kg bw/day for the female and male Wistar rat. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe1131a9-5272-42c1-99b1-c7ac6ad80ff3/documents/6e4745ee-2923-451e-803e-26009aa726af_2f7c12c7-9fec-4a5b-8210-3389bad42e79.html,,,,,, "2,2'-methylenebis[6-(1-methylcyclohexyl)-p-cresol]",77-62-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe1131a9-5272-42c1-99b1-c7ac6ad80ff3/documents/6e4745ee-2923-451e-803e-26009aa726af_2f7c12c7-9fec-4a5b-8210-3389bad42e79.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2'-methylenebis[6-(1-methylcyclohexyl)-p-cresol]",77-62-3, Acute Oral Toxicity: LD50 >2000 (male/female Wistar rats). Acute Dermal Toxicity: LD50 >2000 (male/female Wistar rats). Acute inhalation toxicity: LC50> 3.18 mg/l (maximum achievable concentration) (male/female Wistar rats) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe1131a9-5272-42c1-99b1-c7ac6ad80ff3/documents/6ce3cf90-31a1-4500-a1bd-bde114188f3d_2f7c12c7-9fec-4a5b-8210-3389bad42e79.html,,,,,, "2,2'-methylenebis[6-(1-methylcyclohexyl)-p-cresol]",77-62-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe1131a9-5272-42c1-99b1-c7ac6ad80ff3/documents/6ce3cf90-31a1-4500-a1bd-bde114188f3d_2f7c12c7-9fec-4a5b-8210-3389bad42e79.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2'-methylenebis[6-(1-methylcyclohexyl)-p-cresol]",77-62-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe1131a9-5272-42c1-99b1-c7ac6ad80ff3/documents/6ce3cf90-31a1-4500-a1bd-bde114188f3d_2f7c12c7-9fec-4a5b-8210-3389bad42e79.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2'-methylenebis[6-(1-methylcyclohexyl)-p-cresol]",77-62-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe1131a9-5272-42c1-99b1-c7ac6ad80ff3/documents/6ce3cf90-31a1-4500-a1bd-bde114188f3d_2f7c12c7-9fec-4a5b-8210-3389bad42e79.html,,inhalation,LC50,"3,180 mg/m3",no adverse effect observed, "2,2'-methylenebis[6-cyclohexyl-p-cresol]",4066-02-8," Repeated Dose Toxicity: subacute (43 or 44 days (males), until day 5 post partum (females)), repeated dose toxicity / toxicity to reproduction screening study, oral: gavage, Wistar rat m/f, 12/sex/dose (EC 223-773-8, OECD 422, GLP): NOAEL = 100 mg/kg bw/d, based on the severity and adaptive response nature of the findings rather than an absence of findings. Repeated Dose Toxicity: subacute (14 days), oral: gavage, Wistar rat m/f, 3/sex/dose (EC 223-773-8, OECD 422 range-finding study): NOAEL = 1000 mg/kg bw/day, treatment was tolerated well showing no clinical signs or any adverse effects to body weight development or food consumptions Repeated Dose Toxicity: subacute (21 consecutive working days), 3 weeks post-observation, oral: gavage, 10 male white rats (EC 223-773-8, no guideline): NOAEL = 250 mg/kg bw/d (only dose tested) Repeated Dose Toxicity: subacute (28 days), oral: gavage, Wistar rat m/f, 5/sex/dose (EC 277-633-6 containing ca. 10% EC 223-773-8, OECD 407, GLP): NOAEL = 1000 mg/kg bw/day (product), no adverse effects noted up to the limit dose of 1000 mg/kg, corresponding to a NOAEL = 100 mg/kg bw/d (EC 223-773-8 only) ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff1bc56c-abb4-4c32-911a-ed530f19cb60/documents/80b6e44c-4371-411d-ab9d-22e1de7d740f_c8e2a2bf-3451-4eac-9f48-ce48da73082d.html,,,,,, "2,2'-methylenebis[6-cyclohexyl-p-cresol]",4066-02-8,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff1bc56c-abb4-4c32-911a-ed530f19cb60/documents/80b6e44c-4371-411d-ab9d-22e1de7d740f_c8e2a2bf-3451-4eac-9f48-ce48da73082d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2,2'-methylenebis[6-cyclohexyl-p-cresol]",4066-02-8," Acute Toxicity oral: Wistar rats m/f, oral: gavage, 2000 mg/kg bw (OECD 401, EU method B.1, GLP): LD50 > 2000 mg/kg, LD0 ≥ 2000 mg/kg, no animal died during study duration,no symptoms of poisoning were observed, no pathological findings Acute Toxicity oral: oral: gavage, 1 or 2.5 g/kg bw to each 3 male rats:LD50 > 2500 mg/kg, LD0 ≥ 2500 mg/kg, no deaths noted, no symptoms of poisoning observed Acute Toxicity inhalation: 1 cat, 1 rabbit, 1 guinea pig, 2 rats and 4 mice were exposed over 4h to the vaporated test item, mist, whole body,2.25 mg/L: LC0 ≥2.25 mg/L over 4h, no deaths, no animal regardless the species showed any signs of toxicity ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff1bc56c-abb4-4c32-911a-ed530f19cb60/documents/3f0ad76a-22a8-46f9-849e-b1bca24c5fce_c8e2a2bf-3451-4eac-9f48-ce48da73082d.html,,,,,, "2,2'-methylenebis[6-cyclohexyl-p-cresol]",4066-02-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff1bc56c-abb4-4c32-911a-ed530f19cb60/documents/3f0ad76a-22a8-46f9-849e-b1bca24c5fce_c8e2a2bf-3451-4eac-9f48-ce48da73082d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2'-methylenediphenyl diisocyanate",2536-05-2,"Description of Key information The test substance is part of a category approach of methylenediphenyl diisocyanates (MDI) with existing data gaps filled according to ECHA guidance on Read Across (ECHA, 2017).  The read-across category justification document is attached in IUCLID section 13 and summarized below in Additional Informaiton.  Data-gaps in this endpoint is satisfied by weight of evidence and read across from valid repeated dose toxicity studies for the inhalation route. Reliable repeated dose inhalation data in animals is available for the boundary substances (4,4’-MDI, pMDI and 4,4’-MDI/DPG/HMWP). The chronic repeated dose toxicity study (Reuzel et al. 1994, reliability 2) performed with pMDI is a guideline study (OECD 451). In addition, valid sub-chronic and sub-acute repeated dose toxicity studies are available  for pMDI (Reuzel et al. 1994, Kilgour et al. 2002, reliability 2). For the 4,4’-MDI a valid chronic inhalation toxicity study is available (Hoymann et al. 1995, reliability 2) and a limited documented sub-chronic inhalation toxicity study (Heinrich et al. 1991, reliability 4). For the boundary substance 4,4’-MDI/DPG/HMWP a sub-acute toxicity study is available (Ma-Hock, 2021, reliability 1).   Proposed Testing: To support this weight of evidence and read across approach additional repeated dose toxicity testing is planned. It is considered to perform a sub-chronic inhalation toxicity study (OECD 413) with boundary substance 4,4’-MDI/DPG/HMWP. Additional, combined Repeated Dose Toxicity studies with Reproductive/ developmental Toxicity Screening tests (OECD 422) will be performed on 9 substances representing all sub-groups and key structural/chemical characteristics (see overview attached in Annex 27 in Chapter 13). These screening studies will confirm the proposed MoA on repeated dose toxicity or identify substances that may require additional testing.   Available information: Several sub-acute, sub-chronic and chronic studies have been performed on 4,4’-MDI, pMDI and 4,4’-MDI/DPG/HMWP and are described in Category justification document in Chapter 13 . A repeated dose dermal toxicity study was performed in rabbits with pMDI (Wazeter et al., 1964a) but since this only has fourteen days of treatment and only slight local skin irritants effects were observed this is omitted from this chapter, but rather described in chapter addressing skin irritation. As with the acute studies, in all repeated dose studies, toxic effects were limited to the site of contact with no systemic effects observed distant from the portal of entry. Key repeated dose studies days are described below:  The ‘Monomeric MDI’ subgroup In a subchronic inhalation study with 4,4’-MDI, female Wistar rats were exposed to concentrations of MDI of 0, 0.3, 1 or 3 mg 4,4’-MDI/m3 for 18 hours a day on 5 days a week for 13-weeks. Reduced body weight gains and an increase in relative lung weights were found at 1 mg/m3 and above. At and above this concentration infiltration of mononuclear cells, goblet cell hyperplasia, erosion of the respiratory epithelium in the upper respiratory tract, hyperplasia of the bronchus-associated lymphatic tissue and inflammatory changes of the lung were additionally observed. At 3 mg/m3 there was an increase in the total cell count and proportion of granulocytes and lymphocytes, a decrease in the proportion of macrophages in the bronchoalveolar lavage fluid, an increase in protein, β-glucuronides and lactate dehydrogenase, and changes in lung function. No effects were observed at 0.3 mg/m3 (Heinrich et al., 1991). A subsequent chronic inhalation study (Hoymann et al., 1995) was conducted with 4,4’-MDI. Female Wistar rats were exposed to 0.23, 0.70 or 2.05 mg 4,4’-MDI/m³ aerosols for 17 hours/day, 5 days /week for up to 24 months. Essentially, a dose-dependent impairment of the lung function in terms of an obstructive-restrictive malfunction with diffusion disorder, increased lung weights, an inflammatory reaction with increased appearance of lymphocytes in the lung in the high dose group as a sign of specific stimulation of the immune system by MDI, an intermediately retarded lung clearance in the high dose group as well as dose-dependent interstitial and peribronchiolar fibrosis, alveolar bronchiolisations and a proliferation of the alveolar epithelium, which was classified as preneoplastic, as well as a bronchiolo-alveolar adenoma were identified. The LOAEC for the female rat was identified as 0.23 mg/m3 based on minor histopathological pulmonary lesions after long-term inhalation of 4,4'-MDI aerosols.  A comparison of the pulmonary effects described in female rats from the two chronic studies, one with 4,4’-MDI and the other with pMDI, was published by Feron et al. (2001). To assist the comparison and account for the lower proportion of mMDI in pMDI, the authors normalized the different MDI doses to total inhalation exposures calculated as 559; 1,972; 2,881; 6,001; 17,575 and 17,728 mg mMDI.h/m3. The major pulmonary effects in the two studies were characterized by hyperplasia, interstitial fibrosis and a low incidence of bronchiolo-alveolar adenoma, the latter occurring in the high exposure groups of both studies (i.e. total inhalation exposures of 17,728 and 17,575 mg.h/m3). Both studies also reported the presence of particle-laden macrophages predominantly in the alveoli close to the alveolar ducts which in some cases, particularly in high dose groups, were associated with areas of fibrosis. There was a clear quantitative dose response in both studies with the lowest dose of 559 mg mMDI.h/m3 from the study reported by Reuzel et al. (1994a) being described as the no-observed-adverse-effect-level (NOAEL) Feron et al. (2001) also suggested that the mild histopathological changes seen in the low exposure animals (0.23 mg/m3) in the Hoymann et al. (1995) study, would not have occurred if the exposure had been for six hours/day. An exposure of 0.2 mg/m3 over a six-hour period was judged to be the NOAEL in both studies. Overall, the analysis concluded that both studies showed similar qualitative responses to exposures to pMDI or 4,4’-MDI when compared on the basis of mMDI content..  The ‘Oligomeric MDI’ subgroup In a subacute inhalation study by Kilgour et al. (2002), female Alpk:APfSD rats were exposed to pMDI aerosol at  concentrations of 0, 1.0, 4.0 and 10 mg pMDI/m3, for 6 hours/day, 5 days/week, for  28 days, a 30-day recovery group was included. No clinical signs were noted during exposure and recovery phase. Body weights in all groups were comparable to controls throughout exposure and recovery periods. Lung weights were increased in animals exposed to 10 mg/m3 at the end of the exposure period, although this had returned to control values by day 30 post-exposure. Lung weights of all other treated groups were in the range of the control group. A dose-dependent influx of inflammatory cells, total protein levels and increase in enzyme activities indicated an inflammatory reaction. A statistically significant increase in both the total number of cells counted and alveolar macrophages in lavage fluid was noted at 10 mg/m3, and a slight (but not statistically significant) following exposure to 4 mg/m3. The polymorphonulear leukocytes (PMNs) and lymphocyte/other cells showed statistically significant, concentration-related increases in cell counts following exposure to 4 or 10 mg/m3 pMDI. At the end of the recovery phase, cell counts in exposed animals had returned to normal. Animals of the exposure groups 4 and 10 mg/m3 showed an increase of macrophages containing vacuoles (foamy macrophages), whereas the 1 mg/m3 group was in the range of the control animals. At the end of the recovery period few macrophages vacuoles were still discernable. In animal exposed to 10 mg/m3 pMDI a statistically significant increase in total protein and alkaline phosphatase activity was noted in lavage fluid at the end of exposure, whereas lactate dehydrogenase and N-acetyl glucosaminidase (NAG) activities were not increased. All other treated groups in the main study and all groups at the end of the recovery phase showed values similar to controls. A transient increase in phospholipids concentration was noted in the lavage fluid from animals exposed to 10 mg/m3 pMDI after exposure, no differences from control values were seen at the end of the recovery phase. In all exposure groups a statistically significant concentration-related increase in BrdU labelling index in terminal bronchioles were seen; a similar increase in centro-acinar alveoli were found in animals exposed to 4 and 10 mg/m3 pMDI. At the end of the recovery phase, labelling indices were similar to control values at all concentrations. No macroscopic abnormalities were noted. Histopathology of the lung showed in animals exposed to 10 mg/m3 pMDI an increase in bronchiolitis and thickening of the centro-acinar region, interstitial thickening at the acinar junctions, and accumulations of alveolar macrophages containing yellow pigment in the cytoplasm. In animals exposed to 4 mg/m3 pMDI 1/5 animals showed thickening of the centro-acinar region and bronchiolitis and 1/5 animals exposed to 1 mg/m3 pMDI showed bronchiolitis. After the recovery phase, alveolar macrophages containing a yellow pigment were present in the interstitium in all animals that had been exposed to 10 mg//m3 pMDI but were absent in animals exposed to 1 or 4 mg/m3 pMDI. In addition, 1/5 animals exposed to 10 mg/m3 pMDI still had bronchiolitis and centro-acinar thickening, but at a reduced severity and distribution to that seen in the main study. Ultrastructural findings suggest a perturbation of surfactant homeostasis by exposure to pMDI which is supported by the small increase in measured phospholipids and observation of foamy macrophages. Animals exposed to 10 mg/m3 pMDI showed a slight thickening of the interstitial alveolar wall in 3/5 animals. The thickening in the centro-acinar region was due to thickening of the interstitium, which partly attributable to the absorption of alveolar macrophages and partly due to excess collagen. Compound -related increases in the levels of surfactant were noted in the alveolar macrophages and lumina. In the alveolar macrophages, minimal to slight increases in lamellar surfactant were associated with minimal and moderate increases in amorphous surfactant in animals exposed to 10 mg/m3 pMDI.  In the alveolar lumina, minimal to moderate increase in cell debris were noted in animals exposed to 10 or 4 mg/m3 pMDI. Associated with these increases in cell debris were increases in the amount of crystalline and lamellar surfactant. At 1 mg/m3 there was evidence of effect on surfactant homeostasis, with small increase in number and size of type II cell lamellar bodies and similar increases in  amorphous, crystalline and lamellar surfactant in the  alveolar lumina, which was seen as an adaptive response to exposure to low levels of irritant aerosol. Based on findings of histopathology, bronchiolitis noted at 1 mg/m3 and evidence of effect on surfactant homeostasis at 1 mg/m3, NOAEC could not be defined and the LOAEC was set at 1 mg/m3 pMDI.   In a subchronic inhalation study (SC1) by Reuzel et al. (1994b) (original report Reuzel et al. (1985)) Wistar rats were exposed to pMDI aerosol at concentrations of 0, 0.35, 1.4 and 7.2 mg pMDI/m3, for 6 hours/day, 5 days/week over a period of 13 weeks. Transient slight growth retardation was observed in male rats exposed to 7.2 mg/m3 air. Haematology, blood chemistry and urinalysis did not show treatment-related effects. There were no significant differences in organ weights between the test and control groups. Gross examination at autopsy did not reveal changes which could be ascribed to the test substance. Histopathological examination revealed yellow material (possibly polyurea originated from test material) in the respiratory tract of rats exposed to 7.2 mg/m3. Under the conditions of this test no clear NOAEC was determined. In an associated second subchronic study (SC2) by Reuzel et al. (1994b) (original report by (Reuzel et al., 1986)), Wistar rats were exposed to higher aerosol concentrations of 4.1, 8.4 and 12.3 mg pMDI /m3 air for 3-months. Severe respiratory distress was observed in rats exposed to 12.3 mg/m3 with 11 males and 4 females dying during the exposure period. Significantly less severe signs were seen in rats exposed to 8.4 mg/m3. This study demonstrated adverse effects in the lungs and nasal cavity at levels of 4.1 mg/m3 and above and included histological effects in the lungs (increase in alveolar macrophages and interstitial macrophage infiltration) and in the mediastinal lymph nodes (macrophages with yellowish inclusions). At 8.4 mg/m³ and above increased relative lung weights, partially reversible damage to the olfactory epithelium and basal cell hyperplasia were observed.   In a combined chronic toxicity and carcinogenicity key study (Reuzel et al., 1990; Reuzel et al., 1994a) conducted according to OECD Guideline 453 rats were exposed for 6 hours/day, 5 days/week for one year (satellite groups) or two years (main groups) to aerosol concentrations of 0, 0.2, 1.0 or 6.0 mg pMDI /m3 (analytical concentrations: 0, 0.19, 0.98, 6.03 mg/m3). The effect of chronic exposure of rats to respirable pMDI aerosol was confined to the respiratory tract. The compound-related changes were found in the nasal cavity, the lungs and the mediastinal lymph nodes, and to some degree they were already present after one year of exposure. Histopathology of the organs/tissues investigated showed that exposure to 6.0 mg/m3 over two years was related to the occurrence of pulmonary tumors in males (6 adenomas and 1 adenocarcinoma) and females (2 adenomas). In this two-year rat study, the NOAEC was 0.2 mg/m3 for the repeated dose toxicity of pMDI. The LOAEC was set at 1.0 mg/m3.   The ‘MDI and its reaction products with glycols’ subgroup Pre-liminary results are available for a subacute inhalation study (Ma-Hock, 2021) which was conducted according to OECD 412 on 4,4’-MDI/DPG/HMWP. This study was designed as closely as possible to the study described above by Kilgour et al. (2002) on pMDI to generated comparable data on 2 category boundary substances.  A qualitative and quantitative comparison between these studies will be described in more detail in the category justification document attached to this dossier.   Male and female Wistar rats (7 animals per sex and exposure group) were exposed to 4,4’-MDI/DPG/HMWP liquid aerosol at  concentrations of 0, 1.0, 4.0 and 10 mg/m3 (analytical conc.: 0, 1.0, 3.9 and 9.8 mg/m3), for 6 hours/day, 5 days/week, for  4 weeks (main study). To evaluate the reversibility of effects, 28-day recovery groups were included (recovery control group and 10 mg/m3 exposure group). No mortality was observed throughout the study. During the exposure period clinical signs like respiration sound and piloerection were noted in animals exposed to 10 mg/m3 and one animal exposed to 4 mg/m3. In all other animals, no clinical signs were observed during the exposure period. No clinical signs were observed during the recovery period. Body weights of males exposed to 10 mg/m3 was slightly lower throughout the exposure period but were in the range of the concurrent control at the end of the recovery period. All other groups were comparable throughout exposure and recovery period. A significant increase in mean relative lung weights was observed in males and females of the 10 mg/m3 exposure group, although this had returned to control values at the end of the recovery period. Regarding clinical chemistry, one female of exposure group 4 mg/m3 and 2 females of exposure group 10 mg/m3 (main study) showed an increase in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activities. These effects were regarded as caused by the implant of Alzet osmotic minipumps, thus regarded as treatment related but not substance related effect. All other changes in clinical chemistry observed in exposed animals were regarded as incidental and not treatment related. In animals exposed to 10 mg/m3 a lymphocytic-monocytic inflammation was observed indicated by increased total cell counts as well as absolute and relative lymphocyte and monocyte counts. This type of inflammation was confirmed by marginal, non-relevant increases of lactate dehydrogenase (LDH BAL) and alkaline phosphatase (ALP BAL) activities, but relevantly, slight increases of γ-glutamyl transferase (GGT BAL) activities among these individuals. In BAL of rats exposed to 10 mg/m3 increases of high total protein levels were observed. At the end of the recovery period total protein levels and enzyme activities and cell counts had returned to control levels. Treatment-related histopathological findings were observed in lungs, trachea, larynx, tracheobronchial lymph nodes and mediastinal lymph nodes in male and female animals. Interstitial inflammation of the terminal bronchi was observed in animals exposed to 4 mg/m3 and 10 mg/m3. Hypertrophy/hyperplasia of large, medium and terminal bronchi were observed in animals exposed to 4 mg/m3 and 10 mg/m3, which was associated with an increase in cell proliferation, indicated as a significant increase in BrdU labeling indices. A statistically significantly increased cell proliferation was also observed in animals exposed to 1 mg/m3 in large, medium and terminal bronchi. In alveoli there was a trend towards increased cell proliferation, however there was no dose-response relationship, statistically significance was only seen in males exposed to 10 mg/m3. Pneumocytes type II cells showed minimal proliferation in few animals of the 4 mg/m3 and 10 mg/m3 exposure group. Interstitial inflammation of alveoli was noted in males of the 4 mg/m3 and 10 mg/m3 exposure groups. In the alveolar lumina, neutrophilic infiltration was found occasionally. Debris was seen in one male of the 4 mg/m3 exposure group in alveolar lumina consisting of fragments of cells. Alveolar macrophage accumulation was seen with increased severity in males and females exposed to 10 mg/m3. A minimal increase in alveolar macrophages was still present in females at the end of the recovery period. Macrophages with foamy cytoplasm (foamy macrophages) were observed in males of the 4 mg/m3 and 10 mg/m3 exposure groups and in females exposed to 10 mg/m3. Epithelial alteration in the larynx was noted with increased incidence and severity in treated animals and was characterized by a focal, ventrally located change of the epithelium from cuboidal to focally flattened cells and was noted with increased incidence and severity in treated animals. Lymphocyte infiltration was seen in the submucosa in treated animals. The trachea epithelium on the tip of the carina was changed from its normal cuboidal, ciliated appearance to a single layer of flattened cells with loss of cilia in treated animals. Hyperplasia of the trachea epithelium was seen in males exposed to 4 mg/m3 and 10 mg/m3 and females exposed to 10 mg/m3. Beneath the epithelium, there was an increased infiltration of lymphocytes in single animals. A diffuse enlargement of mediastinal and tracheobronchial lymph nodes was seen in treated animals. The histopathological changes noted after termination of exposure were mostly reversible. An increased incidence of minimal alveolar macrophage accumulation was still observed at the end of the recovery period in treated females. Increased cell proliferation in alveoli was still observed in treated males. No other treatment related findings were observed at the end of the recovery period.   In summary, substance-related systemic effect was not observed. Under the current study conditions, the no observed adverse effect level (NOAEL) for systemic toxicity was 10 mg/m³. The NOAEL for local toxicity could not be established due to the slight changes in labeling indices present at 1 mg/m³ (Ma-Hock, 2021).   Human information A large dataset is available in human epidemiological and case studies for chronic exposure to diisocyanates in the workplace and reported effects are limited to respiratory system. Effects associated with respiratory sensitization are described in chapter sensitization and potential carcinogenicity is described in carcinogenicity chapter. In general, long term exposure to MDI substances can result in non-immunological decreases in lung function and other respiratory symptoms associated with chronic irritation. Interpretation of many of these studies is confounded by simultaneous exposure to TDI and inaccurate exposure data. Despite these limitations, pMDI concentrations as low as 87 ppb (0.9 mg/m3) were shown to correlate with deterioration in lung function whereas when exposures were below a maximum concentration of 20 ppb (0.2 mg/m3), no significant changes in lung spirometry was generally observed (DFG, 2008). The frequency of respiratory complaints was not significantly increased when exposure levels were below 10 ppb (0.1 mg/m3) (DFG, 2008).     Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint: No system toxicity up to the highest dose group tested   Inhalation is the most appropriate route of exposure for assessing occupational risk of substances of the MDI category in humans. Repeated dose studies are available for the three boundary substances , GLP compliant study on both 4,4’-MDI and pMDI with reliability 2, conducted according to OECD Guideline 453 (combined chronic toxicity/carcinogenicity studies) and two 28 day studies on pMDI and 4,4’-MDI/DEG/HMWP. In all repeated dose studies, toxic effects were limited to the site of contact with no systemic effects observed distant from the portal of entry, which is in line with the discussed MoA of MDI toxicity (see category justification document).   Repeated dose toxicity: inhalation - local effects (target organ) respiratory: respiratory tract   ​ Inhalation is the most appropriate route of exposure for assessing occupational risk of substances of the MDI category in humans. Repeated dose studies are available for the three boundary substances, GLP compliant study on both 4,4’-MDI and pMDI with reliability 2, conducted according to OECD Guideline 453 (combined chronic toxicity/carcinogenicity studies) and two 28 day studies on pMDI and 4,4’-MDI/DEG/HMWP. Consistent with the hypothesized MoA proposed (see category justification document) for these substances the primary health effect following inhalation exposure is local irritation within the respiratory tract without significant systemic exposure or toxicity. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75d8c59d-1502-40e9-af86-29cc87d99c2d/documents/3c2aa6cb-5926-4781-bf26-ff77265a67f0_3e131e9f-81b8-4e96-b39e-ddac5c3dbca8.html,,,,,, "2,2'-methylenediphenyl diisocyanate",2536-05-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75d8c59d-1502-40e9-af86-29cc87d99c2d/documents/3c2aa6cb-5926-4781-bf26-ff77265a67f0_3e131e9f-81b8-4e96-b39e-ddac5c3dbca8.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1 mg/m3,adverse effect observed, "2,2'-methylenediphenyl diisocyanate",2536-05-2,"Data gap filling for the acute inhalation toxicity endpoint is achieved using the category approach according to ECHA guidance on read-across (ECHA, 2017c). For this endpoint, all effects are consistent with the hypothesized MoA and direct electrophilic reactions of NCO with biological nucleophiles. Modified MDI substances contain different higher molecular weight constituents, and all have in common a high content of bioaccessible low molecular weight MDI constituents responsible for presenting NCO reactivity, scenario 4 or 6 according to the RAAF considered as most appropriate due to a common mechanism. Selection between scenario 4 and 6 depends essentially upon the presence of variation in the properties i.e. magnitude of effect. Since it has been demonstrated that the bioaccessible low molecular weight MDI constituents are responsible for presenting NCO reactivity, and the higher molecular weight MDI constituents do not contribute to the observed toxicity it is reasonable to assume that their presence in these mixtures attenuates toxicity. Further, as a worst-case approach is adopted in which 4,4’-MDI isomer is used for read-across to all substances of the MDI category, then use of RAAF Scenario 4 (variations in the properties observed among source substances) is justified over scenario 6.   Acute oral toxicity In the case of oral exposure, before the reactive NCO groups present on the substances of the MDI category have opportunity to react locally, or be absorbed, they polymerize in the acid environment of the stomach to form solid polyureas that are excreted via the feces without being absorbed. Consequently, if exposure were to occur by the oral route this would not lead to local or systemic effects. For MDI Mixed Isomers, the key study (Reliability 1) did not record mortality up to the limit dose of 2,000 mg/kg bw . A supporting study describing the acute oral toxicity of pMDI conducted similar to OECD 401 guideline (Reliability 2) also did not find any mortality up to the maximum dose tested, hence the LD50 is greater than 10,000 mg/kg bw . Other studies on MDI substances are consistent with this, albeit with lower reliability.  Four additional acute oral toxicity studies (Reliability 1) have been conducted on other representative substances of the category subgroups (i.e. ‘MDI, its condensation products and the reaction products with glycols’ and ‘MDI and its reaction products with glycols’). In all cases, there was no mortality up to the limit dose (5,000 mg/kg). The lack of mortality in the available acute oral toxicity across the available studies, alongside the lack of gross lesions in distal tissues (e.g. liver, kidney etc.) supports the lack of systemic bioavailability. The NCO groups present on MDI substances react with acids within the stomach leading to formation of an insoluble polymerized mass that is excreted in the feces without being absorbed (see Toxicokinetics).  Supporting evidence comes in the form of several accidental ingestion reports in dogs where ingestion of MDI based glues produced no intrinsic toxic effects other than the formation of a solid polyurea mass that may lead to gastric obstruction. When the mass was removed by surgery, rapid and complete recovery was achieved (Horstman et al., 2003; Ohngren, 2007).     Acute dermal toxicity In the case of dermal exposure, before the reactive NCO groups present on MDI substances have opportunity to be absorbed to any significant extent through the stratum corneum they react with proteins and moisture at the skin surface leading to the formation of an insoluble polymerized mass thereby limiting dermal absorption and systemic availability (Leibold 1999). Modified MDI substances, having a higher molecular weight than mMDI isomers and due to their higher molecular volume, increased octanol-water partition coefficient and decreased water solubility will in any event not be able to penetrate the stratum corneum (Bartels 2021). The available acute dermal toxicity studies indicate that all substances of the MDI category have low acute dermal toxicity. The key study describing the acute dermal toxicity of pMDI in rabbits did not find lethality up to the maximum dose tested, and the LD50 was greater than 9,400 mg/kg bw (Wazeter et al., 1964a). Other less reliable studies on pMDI or 4,4’-MDI are consistent with this.  Observed differences in LD50 values between pMDI and 4,4'-MDI/TPG are not considered to be significant or represent a trend since they are significantly higher than the limit for classification and are indicative of a lack of systemic exposure. The available data for the substances of the MDI category is consistent with the hypothesis that NCO groups present on MDI substances react with proteins and moisture at the skin surface leading to the formation of an insoluble polymerized mass resulting in limited dermal absorption and systemic availability. The available data and hypothesis is supported by the key dermal absorption study that shows that MDI substances have very low systemic bioavailability (<1 %) (Leibold et al., 1999). By comparison, modified MDI substances, with molecular weight greater than mMDI, will demonstrate even further reduced dermal absorption based upon physico-chemical properties (i.e. increased octanol-water partition coefficient, decreased water solubility, and increased molecular weight), and this has been confirmed with GastroPlus™ modeling (Bartels, 2021). Although a reliable, acute dermal in vivo toxicity data is only available on two category substances, it is considered sufficient for assessment of this endpoint for the category. Due to the low predicted dermal bioavailability of all category substances, and the lack of systemic toxicity demonstrated in the oral acute toxicity studies, additional testing is not justified as all substances of the MDI category would be predicted to have comparable or reduced acute dermal toxicity potential to tested substances.   Acute Inhalation Toxicity Following inhalation exposure the initiating event in hypothesised MoA for acute toxicity in the lung is the reaction of the MDI substance with GSH in the airway lining fluid (adduct formation). Subsequent development of toxic effects is driven by the rate of depletion of GSH. This depletion begins with the reduction in extracellular GSH, which leads to a reduction in intracellular GSH disturbing the redox balance in the cell. With increasing amounts of NCO exposure (e.g. via exposure concentration or bioaccessibility), the protective GSH system gradually becomes overwhelmed, and toxicity evolves along the path: (1) no cytotoxicity; (2) cytotoxic effects; (3) reduced cell viability; and (4) cell death. This is accompanied by increasing extravasation because of increased junction permeability and epithelial damage ultimately causing edema.    The rate of nucleophile depletion by MDI-based substances is driven by the availability of the NCO-group, which itself is a function of (1) the NCO value of the substance and (2) the molecular weight of its constituents (driving its reactive dissolution). Monomeric MDI isomers have been shown to become available at a similar rate in toxicokinetic studies (Wisnewski, 2018; Wisnewski et al., 2019a) which is consistent with the generally comparable LC50 values for all of the isomers. Conversely, higher molecular weight constituents have both a reduced NCO value and exhibit reduced water solubility, making them less accessible to react with GSH. Therefore, the substances with the highest available NCO value and bioaccessibility (mMDI and three-ring oligomers) are the most toxic, while those with increasing amounts constituents less able to react with GHS demonstrate reduced toxicity.   Tests also show that toxicity is limited to portal-of-entry effects. The absence of systemic toxicity is due to the extracellular reactions described above, combined with transcarbamoylation to proteins described in more detail in the Chapter (Toxicokinetics), constitute a detoxification mechanism. Acute toxicity is only observed when this protective mechanism becomes overwhelmed and is limited to the lung. This mode of action is supported with high confidence by reliable acute inhalation data available for multiple MDI isomers and modified MDI substances (described in more detail below). The toxicity of MDI substances will decrease with increasing average molecular weight as these substances will have constituents that are less bioaccessible and with a lower NCO value. For these substances, higher exposure concentration is required to induce toxic effects, which is consistent with the observed results from the available acute inhalation toxicity tests.  Testing proposal: While testing is available on 8 MDI category memeber (including all sub-groups) acute toxicity testing (OECD 403) will be performed on an additional 4 MDI substances.  This information will further support the category hypothesis as well as help to define substance selection and study design for repeat-dose bridging studies.    Available data: The ‘Monomeric MDI’ subgroup Reliable acute inhalation studies are available for all three isomers of mMDI (2,2’-; 2,4’-; and 4,4’-MDI) in accordance with OECD Guideline 403 in a series of studies by (Pauluhn, 2008d; Pauluhn, 2008e; Pauluhn, 2008f). All three substances consist of more than 98 % pure mMDI, corresponding to NCO value of 33%. In all cases, mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA. LC50s were comparable and ranged from 368 to 598 mg/m3 for males and from 559 to 686 mg/m3 for females. For all studies, exposure parameters met internationally recognized recommendations for MMAD and GSD and were similar for all three isomers. The ‘Oligomeric MDI’ subgroup Polymeric MDI (approximately 40 % mMDI; 33 % NCO value, with viscosity of approximately 200 mPas) was tested in an acute inhalation toxicity study according to OECD 403 (Pauluhn, 2008c). Mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA. An LC50 (95 % confidence interval) of 310.2 (266.4-361.3) mg/m3 was determined for pMDI.  Polymeric MDI was also tested following depletion of monomeric MDI resulting in a mixture of 1.2 % mMDI and 98.8 % of higher (> two-ring) oligomers according to OECD 403 (Pauluhn, 2011a). The combined LC50, for male and female rats, for ‘monomer-depleted pMDI’ was greater than 2,188 mg/m3. Average mean mass aerodynamic diameter (MMAD) and geometric standard deviation (GSD) was generally comparable to that of the pMDI containing mMDI (85-87 %). The ‘MDI and its condensation products’ subgroup The acute inhalation toxicity of MDI Mixed isomers/PIR (60 % mMDI and NCO value of 26 %) was tested in an acute inhalation toxicity study according to OECD 403 (Pauluhn, 2012). The combined LC50 for male and female rats was 1,088 mg/m3, mortality was linked to portal of entry effects of the respiratory system, including severe irritation and pulmonary edema. Mortality occurred up to two days post-exposure and was causally related to an acute pulmonary edema. The ‘MDI and its reaction products with glycols’ subgroup Two reliable acute inhalation studies are available for substances of the ‘MDI and its reaction products with glycols’ subgroup. The acute inhalation toxicity of 4,4'-MDI/1,3-BD/TPG/PG (60 % mMDI; 23 % NCO) was conducted according with OECD 403 (Kopf, 2016).  The LC50 was calculated to be 518 mg/m3, and mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA.  The acute inhalation study of 4,4'-MDI/DPG/HMWP (50 % mMDI; 25 % NCO) was tested according to OECD 403 (Hotchkiss and Weidemoyer, 2020). The LC50 is 1,110 mg/m3 for male rats and 1,250 mg/m3 for female rats. The four-hour LC50 is 1.15 mg/L for male and female rats combined. Similar to the other LC50 studies, mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA.   An acute inhalation study was performed in rats at only one concentration level of 2.24 mg/L/1h (Pauluhn 2003, 2004). This study was specifically designed to comply with NFPA 704, and also complied with the limit test of the OECD guideline 403 with deviations (only 1 hr exposure, concentration lower than limit test concentration) and is therefore reliable with restrictions. Exposure of 4,4’-MDI for 1 hr resulted in mortality shortly after exposure of one out of ten rats. Clinical signs were characterised by typical signs of respiratory tract irritation. Necropsy findings were unremarkable in surviving rats, whilst the rat that succumbed displayed signs of lung oedema which was considered to be the cause of death. The LC50 >2.24 mg/L/1h (analytical) in both males and females was determined.        Adequacy of the available data for risk assessment and classification purposes Using the strict GHS LC50 cut-off for classification, the LC50 values obtained for the mMDI would trigger a Category 2 (or Category 3) according to GHS CLP. However, classification for these substances according to ECHA CLP Guidance (2017) text allows for the application of scientific judgement. It must be considered that the LC50 cut-off of 500 mg/m3 (approximately 50 ppm for pMDI), is over 2,500-fold above the saturated vapor concentration for pMDI. This difference is even further exacerbated in the pre-polymer mixtures where the presence of the higher molecular weight fraction even further reduces the vapor pressure making exposure less likely.    Furthermore, the aerosols were generated using sophisticated techniques in the laboratory, whereby extremely small particles are generated in order to meet international guidelines for testing. This size and concentration of aerosol is not generated in the workplace even under foreseeable worst-case conditions (Ehnes et al., 2019). The particle size distribution of aerosols formed during actual spraying applications has virtually no overlap with that of the highly respirable aerosol generated in inhalation studies (see EC (2005)). Due to a very low vapor pressure (<0.01 Pa) MDI substances are not inherently toxic by inhalation since the saturated vapor concentration would be orders of magnitude below toxic concentration. It is only with modification and input (in terms of heat, cooling and size screening) that MDI substances become toxic after inhalation. In the EU risk assessment report (EU 2005) MDI is classified as  harmful by inhalation.   The acute inhalation data of pMDI and 4,4’-MDI data were considered by EU experts, and their conclusion that MDI be classified as “Harmful” and  reported in the 25th Adaptation to Technical Progress (ATP) to the Dangerous Substances Directive (67/548/EEC). This was endorsed in the 28th ATP and both MDI substances remain as “Harmful” in the 30th ATP (adopted by Member States on 16 February 2007 and published 15th September 2008). The original decision was upheld in the EU Risk Assessment of MDI (Directive 793/93/EEC, 3rd Priority List) published in 2005, noting that considering “the exposure assessment, it is reasonable to consider MDI as harmful only and to apply the risk management phrase ‘harmful by inhalation’. This classification was also endorsed by the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE, now SCHER) in giving their opinion on the Risk Assessment (EC, 2008). With the enforcement of the CLP regulation (Regulation (EC) No 1272/2008) in 2009, the Dangerous Substance/Preparation Directive (DSD) was repealed and harmonized classifications were formally transferred to the CLP regulation; MDI is classified with Acute Tox. 4 H332 (Annex VI Regulation (EC) No 1272/2008 (CLP regu lation). Given the mechanism of action of the MDI substances and the changes in physical chemical properties imparted by the modifications in the modified MDI substances, the entire category is consistent with this guidance and classification, and the classification should not be changed.   The classification as “Harmful”, is equivalent to GHS Category 4. For these reasons, the GHS proposal follows the EU Regulatory lead accepting that the animal data are inappropriate and classified pMDI as GHS acute toxicity category 4 (ISOPA 2007).    Conclusion    Assessment of the available acute toxicity data indicates that inhalation exposure to the aerosols of MDI results in toxicity confined predominantly to the respiratory tract. In terms of hazard characterization, MDI is harmful by inhalation according to EU (H332) and GHS (Cat. 4) classification. MDI is non-toxic after single oral and dermal exposure.     Justification for classification or non classification:    EU classification according to CLP: H332     GHS classification (GHS UN rev.2, 2007): Inhalation route (vapour): Acute Category 4.     Not toxic by the dermal or oral routes. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Results are consistent within the key study Bomhard (1990) (reliability1)and data from a supporting study (Wazeter et al. 1964) (reliability 2). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75d8c59d-1502-40e9-af86-29cc87d99c2d/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_3e131e9f-81b8-4e96-b39e-ddac5c3dbca8.html,,,,,, "2,2'-methylenediphenyl diisocyanate",2536-05-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75d8c59d-1502-40e9-af86-29cc87d99c2d/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_3e131e9f-81b8-4e96-b39e-ddac5c3dbca8.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,2'-methylenediphenyl diisocyanate",2536-05-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75d8c59d-1502-40e9-af86-29cc87d99c2d/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_3e131e9f-81b8-4e96-b39e-ddac5c3dbca8.html,,inhalation,LC50,431 mg/m3,adverse effect observed, "2,2'-oxybis[5,5-dimethyl-1,3,2-dioxaphosphorinane] 2,2'-disulphide",4090-51-1,"The submission substance did not produce adverse effects in a reliable combined repeated dose oral toxicity study with a reproduction / developmental toxicity screening test (NOAEL >/= 1000 mg/kg bw/day). No reliable standard sub-chronic toxicity study (90-day) is available as required in REACH Annex IX columns 1 and 2, under section 8. Thus, a sub-chronic toxicity study (90-day) according to OECD 408 is proposed by the registrant to fill the data gap. In accordance with column 2 of REACH Annexes VIII and IX, studies with inhalation or dermal exposure are not necessary. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline study, no toxic effects observed at highest dose, NOAEL >/= 1000 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70b8d1ae-cb02-4013-a1d7-db9260bf5a88/documents/IUC5-abb4573a-af05-41f9-aaf3-5c8496c16e7a_7b492297-8371-4210-a848-f38900c61dc5.html,,,,,, "2,2'-oxybis[5,5-dimethyl-1,3,2-dioxaphosphorinane] 2,2'-disulphide",4090-51-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70b8d1ae-cb02-4013-a1d7-db9260bf5a88/documents/IUC5-abb4573a-af05-41f9-aaf3-5c8496c16e7a_7b492297-8371-4210-a848-f38900c61dc5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2'-oxybis[5,5-dimethyl-1,3,2-dioxaphosphorinane] 2,2'-disulphide",4090-51-1,"No mortality or toxicity was observed in 2 reliable oral limit tests with doses of 5000 mg/kg bw.A reliable acute dermal toxicity study is lacking, however, a WOE is used based on the following data: • a LD50 value of > 5000 mg/kg bw from a less reliable study• No observed acute oral toxicity up to doses of 5000 mg/kg bw in reliable studies• Very low absorption at dermal exposure, based on an in vitro skin penetration study (see chapter 7.1.2), and • No systemic effects after dermal exposure in a Local Lymph Node Assay (NOAEL >/= 863 µg/kg bw/day). Based on this data, no acute dermal toxicity is expected within the range of classification limits.Inhalation exposure is not an exposure route of concern.Due to the organophosphorous structure or the submission substance, tests were performed with respect to an inhibition of cholinesterase. A reliable and a less reliable in vitro study revealed no anticholinesterase activity. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Based on reliable studies the LD50 was > 5000 mg/kg bw Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): There is no concern with respect to toxicity after acute dermal exposure: a less reliable study with a LD50 > 5000 mg/kg bw is supported by the lack of systemic toxicity in a reliable LLNA (NOAEL >/= 863 µg/kg bw/day for a threefold exposure), route-to-route considerations on toxicokinetics and reliable studies on oral acute toxicity studies with LD50 values > 5000 mg/Kg bw Furthermore, an available fully reliable in vitro dermal penetration study demonstrates that the dermal penetatration of considerable amount of tne substance via skin can be excluded. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70b8d1ae-cb02-4013-a1d7-db9260bf5a88/documents/IUC5-2236be29-5fff-4ddb-bcbb-fc9dc007bbc1_7b492297-8371-4210-a848-f38900c61dc5.html,,,,,, "2,2'-oxybis[5,5-dimethyl-1,3,2-dioxaphosphorinane] 2,2'-disulphide",4090-51-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70b8d1ae-cb02-4013-a1d7-db9260bf5a88/documents/IUC5-2236be29-5fff-4ddb-bcbb-fc9dc007bbc1_7b492297-8371-4210-a848-f38900c61dc5.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,2'-oxydi(ethylamine)",2752-17-2,"Repeated dose toxicity: oral:No repeated dose toxicity via the oral route was available. The study is waived based on following justification:A key study is available for the dermal and inhalation route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the oral route of exposure.Repeated dose toxicity: dermal:A 90 day dermal study was conducted with the read-across substance BDMAEE in rabbits according to OECD guideline 411 with a reliability score of 2. The NOAEL for systemic effects was considered to be greater than the highest tested dose of 8.0 mg/kg/day. All dose levels tested resulted in varying levels of irritation at the exposure site.Repeated dose toxicity: inhalation:A 90 day whole body vapour inhalation study was conducted with the read-across substance BDMAEE in rats similar to OECD guidelines with a reliability score of 2. Doses tested were 0, 0.23, 1.25 and 5.8 ppm. There were signs of ocular and respiratory irritation at all doses. Evidence of minor, non-specific systemic toxicity (weight loss, changes in urinalysis and increase in relative weight of the testes and adrenals in males) was only observed at the highest dose of 5.8 ppm. No target organ toxicity was observed at any dose level. The NOAEC for systemic effects is therefore considered to be 1.25 ppm. LOAEC value of 1.51 mg/m³ (0.23 ppm) was obtained. Various signs of the eyes and respiratory tract irritation at all concentrations were observed. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0396b24e-c604-4137-9889-5bb1aa0f9123/documents/cfdc19b3-114d-4c9f-a47f-84ff4db3a3c3_77ebb70d-ef44-4a9f-83f2-33faadbc54ef.html,,,,,, "2,2'-oxydi(ethylamine)",2752-17-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0396b24e-c604-4137-9889-5bb1aa0f9123/documents/cfdc19b3-114d-4c9f-a47f-84ff4db3a3c3_77ebb70d-ef44-4a9f-83f2-33faadbc54ef.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,8.2 mg/m3,,rat "2,2'-oxydi(ethylamine)",2752-17-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0396b24e-c604-4137-9889-5bb1aa0f9123/documents/cfdc19b3-114d-4c9f-a47f-84ff4db3a3c3_77ebb70d-ef44-4a9f-83f2-33faadbc54ef.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1.51 mg/m3,adverse effect observed,rat "2,2'-oxydi(ethylamine)",2752-17-2,"Acute toxicity - oral: A K1 acute oral toxicity test was performed in male and female Sprague Dawley rats according to a guideline similar to OECD Guideline 401 (Mallory VT, 1983). Acute toxicity - inhalation: An acute inhalation study does not need to be conducted as the substance is classified as corrosive to the skin (according to REACH, Annex VIII section 8.5, column 2). In addition, acute oral and acute dermal toxicity studies with the test substance are available.Acute toxicity - dermal: A K1 acute dermal toxicity test was performed in male and female New Zealand White rabbits according to a guideline similar to OECD Guideline 402 (Mallory VT, 1983). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0396b24e-c604-4137-9889-5bb1aa0f9123/documents/6b1c046e-0535-4059-b2f5-699018f44747_77ebb70d-ef44-4a9f-83f2-33faadbc54ef.html,,,,,, "2,2'-oxydi(ethylamine)",2752-17-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0396b24e-c604-4137-9889-5bb1aa0f9123/documents/6b1c046e-0535-4059-b2f5-699018f44747_77ebb70d-ef44-4a9f-83f2-33faadbc54ef.html,,oral,LD50,961 mg/kg bw,adverse effect observed, "2,2'-oxydi(ethylamine)",2752-17-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0396b24e-c604-4137-9889-5bb1aa0f9123/documents/6b1c046e-0535-4059-b2f5-699018f44747_77ebb70d-ef44-4a9f-83f2-33faadbc54ef.html,,dermal,LD50,"3,550 mg/kg bw",adverse effect observed, "2,2'-Oxydiethanol, propoxylated",9051-51-8,"NOAEL (28 days repeated dose, Wistar): ≥ 1000 mg/kg bw. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/623bab6c-b126-4ce9-a2c2-d2cc9a828652/documents/IUC5-0170f941-ab5a-4951-ae4e-b5a62467cd47_8e1b55ba-d6f5-431c-b2d5-b7b257644a37.html,,,,,, "2,2'-Oxydiethanol, propoxylated",9051-51-8,The oral and dermal LD50-values of the substance were found to be 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/623bab6c-b126-4ce9-a2c2-d2cc9a828652/documents/IUC5-2aed3488-03a8-4a68-9793-70f4cea87239_8e1b55ba-d6f5-431c-b2d5-b7b257644a37.html,,,,,, "2,2'-phenyliminodiethanol",120-07-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45c30ae4-797a-4ddd-b211-7fe9167197c7/documents/cd96222e-1573-4c77-a2e0-10cf5a2edead_d77c823a-3621-4379-8443-b39570a9fe22.html,,oral,LD50,"3,200 mg/kg bw",no adverse effect observed, "2,2'-p-phenylenedioxydiethanol",104-38-1, The substance is not toxic after oral repeated exposure. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfd72127-5117-453e-9f90-403cc17eede8/documents/IUC5-f2d5ff8c-cd3a-445c-a6c3-0e2b40834812_16f394a8-be1d-4361-bb02-f551be63f06b.html,,,,,, "2,2'-p-phenylenedioxydiethanol",104-38-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfd72127-5117-453e-9f90-403cc17eede8/documents/IUC5-f2d5ff8c-cd3a-445c-a6c3-0e2b40834812_16f394a8-be1d-4361-bb02-f551be63f06b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,2'-p-phenylenedioxydiethanol",104-38-1,HQEE is of low acute toxicity in mammals by both the oral and dermal routes. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfd72127-5117-453e-9f90-403cc17eede8/documents/IUC5-6270150a-ef1f-4eab-9f07-cfaaa091602a_16f394a8-be1d-4361-bb02-f551be63f06b.html,,,,,, "2,2'-p-phenylenedioxydiethanol",104-38-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfd72127-5117-453e-9f90-403cc17eede8/documents/IUC5-6270150a-ef1f-4eab-9f07-cfaaa091602a_16f394a8-be1d-4361-bb02-f551be63f06b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,2'-p-phenylenedioxydiethanol",104-38-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfd72127-5117-453e-9f90-403cc17eede8/documents/IUC5-6270150a-ef1f-4eab-9f07-cfaaa091602a_16f394a8-be1d-4361-bb02-f551be63f06b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2'-thiodiethanethiol",3570-55-6,"The LD50 value of DMDS in the rat is between 50 and 300 mg/kg bw. The LD50-cut-off value according to OECD TG 423 was 200 mg/kg bw. DMDS should be classified as Acute Tox 3 - H301: Toxic if swallowed. Study conducted according to OECD 403: Female and male Sprague Dawley rats were exposed to 4.8 mg/L aerosol composed of the test item (DMTP) in air. No mortality occurred. Signs were labored breathing, secretory responses and red/flaky skin, transient adverse effect on body weight. Thus; the LD50 is considered to be > 4.8 mg/L. Study conducted according to OECD 403 including neurological examinations. Female and male Sprague Dawley rats were exposed to 4.2 mg/L aerosol composed of the test item (DMTP) in air. No mortality occurred. Signs were labored breathing, secretory responses and red/flaky skin, transient adverse effect on body weight, detailed neurological examinations showed a transient decreased muscle tone and reflexes as well as abnormal gait. Thus; the LD50 is considered to be > 4.2 mg/L. Study conducted according to OECD 403 with neurological examinations. Female and male Sprague Dawley rats were exposed to 0.0021 mg/L decomposition products composed of the heated test item (DMTP) in air. No mortality occurred. Signs were labored breathing, nasal discharge and moist rales. No other adverse effects were reported. Thus, a LD50 value could not be established. Study conducted according to OECD 402. Female and male New Zealand White rabbits were dermally exposed to DMTP at a concentration of 2000 mg/kg bw under occlusive conditions for 24h with a subsequent 14 days observation period. No mortality occurred. No significant dermal or systemic toxicity was seen throughout the study, gross postmortem observations were similar to those seen in control animals. Thus, the LD50 is considered to be > 2000 mg/kg bw. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d360efa-f7e0-4f8b-a10d-dff71cc67885/documents/12ff5729-f755-4bd2-bf70-3884974aedd6_249ff903-32ce-4da8-8f17-8dadf6f356d7.html,,,,,, "2,2'-thiodiethanethiol",3570-55-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d360efa-f7e0-4f8b-a10d-dff71cc67885/documents/12ff5729-f755-4bd2-bf70-3884974aedd6_249ff903-32ce-4da8-8f17-8dadf6f356d7.html,,oral,LD50,200 mg/kg bw,adverse effect observed, "2,2'-thiodiethanethiol",3570-55-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d360efa-f7e0-4f8b-a10d-dff71cc67885/documents/12ff5729-f755-4bd2-bf70-3884974aedd6_249ff903-32ce-4da8-8f17-8dadf6f356d7.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,2'-thiodiethanethiol",3570-55-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d360efa-f7e0-4f8b-a10d-dff71cc67885/documents/12ff5729-f755-4bd2-bf70-3884974aedd6_249ff903-32ce-4da8-8f17-8dadf6f356d7.html,,inhalation,LC50,> 4.8 mg/L,adverse effect observed, "2,2'-vinylenebis[5-methylbenzoxazole]",1041-00-5," Based on the available acute oral and dermal studies the test material is not toxic, at a dose level of 2000 mg/kg of body weight. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6cfdaea1-907f-48a0-bbbd-38400df37fd4/documents/dce2d61e-287e-4701-b568-4f528dfb4e2a_a99a86e8-26e1-40ba-accb-fb8f6e0a9908.html,,,,,, "2,2'-vinylenebis[5-methylbenzoxazole]",1041-00-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6cfdaea1-907f-48a0-bbbd-38400df37fd4/documents/dce2d61e-287e-4701-b568-4f528dfb4e2a_a99a86e8-26e1-40ba-accb-fb8f6e0a9908.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2'-vinylenebis[5-methylbenzoxazole]",1041-00-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6cfdaea1-907f-48a0-bbbd-38400df37fd4/documents/dce2d61e-287e-4701-b568-4f528dfb4e2a_a99a86e8-26e1-40ba-accb-fb8f6e0a9908.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,3,3-trimethyl-3H-indole-5-carboxylic acid",84100-84-5, Acute oral toxicity: discriminating dose >5000 mg/kg bw; RL2; GLP; No effects were observed at the dose of 3100 mg/kg bw. Animals showed slight clinical signs after 1 day (males) and 2 days (females) of application of the 5000 mg/kg bw dose; all effects fully reversed after 72 hours of application. Acute dermal toxicity: no study available Acute inhalation toxicity: no study available ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c8d4fd2-aba2-4f7a-a52b-928c6e635978/documents/87dca051-74e9-4775-88f2-a941e05df6b9_4ccdc189-7b70-4ab6-bed5-6501aa1566c8.html,,,,,, "2,3,3-trimethyl-3H-indole-5-carboxylic acid",84100-84-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c8d4fd2-aba2-4f7a-a52b-928c6e635978/documents/87dca051-74e9-4775-88f2-a941e05df6b9_4ccdc189-7b70-4ab6-bed5-6501aa1566c8.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2,3,4-trihydroxybenzaldehyde",2144-08-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The result refers to benzaldehyde, data from ChemID (https://chem.nlm.nih.gov/chemidplus/name/benzaldehyde). Source: Food and Cosmetics Toxicology. Vol. 2, Pg. 327, 1964. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ed4270b-de2d-4960-9a40-f15123c5221e/documents/1eabcb1f-de55-4e44-83cb-bcbd9510d30c_f29de540-209c-48ce-8c1a-6306beb0f943.html,,,,,, "2,3,4-trihydroxybenzaldehyde",2144-08-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ed4270b-de2d-4960-9a40-f15123c5221e/documents/1eabcb1f-de55-4e44-83cb-bcbd9510d30c_f29de540-209c-48ce-8c1a-6306beb0f943.html,,oral,LD50,"1,300 mg/kg bw",adverse effect observed, "2,3,4-trihydroxybenzophenone",1143-72-2,"The acute oral LD50 for male rats was determined to be greater than 5000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is considered to be of sufficient quality to address the endpoint. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d89327b-837b-4628-a394-036810c4ae8c/documents/db5fab6a-23e9-4d60-a046-3364ce417866_81a3ca06-2d96-46b7-acc2-d2babda9f967.html,,,,,, "2,3,4-trihydroxybenzophenone",1143-72-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d89327b-837b-4628-a394-036810c4ae8c/documents/db5fab6a-23e9-4d60-a046-3364ce417866_81a3ca06-2d96-46b7-acc2-d2babda9f967.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "2,3,5-trimethylphenol",697-82-5," Repeated dose toxicity: Oral Combined repeated dose repro-devp. Screen was performed for 2,3,5 Trimethylphenol to determine its repeated oral toxic nature upon repeated exposure to 12 male and 12 female Crl: CD (SD) rats. The test chemical in olive oil was dosed at dose levels of 0, 100, 300, 1000 mg/kg/day for 42 days in males and 42 -46 days (from 14 days before mating to day 4 of lactation) for females. A recovery group was also included in the study at a dose level of 0 or 1000 mg/Kg/day consisting of 5 males and 5 females. The animals were observed for clinical signs, mortality, body weight and food consumption, urinanalysis, hematology, blood chemistry, organ weights and histopathology parameters.   Soiled perigenitalia with urine was noted in male and female animals at 300 and 1000 mg/kg/day, transient lethargy and ataxic gait after dosing was noted in 1000 mg/Kg/day dosed males and 300 and 1000 mg/Kg/day dosed female animals. One female animal each (n: 12) at 300 and 1000 mg/kg/day was found dead during the study. A decrease in body weight gain was observed at 300 mg/kg/day (test group) and 1000 mg/kg/day (test and recovery group) in male animals and at 1000 mg/kg/day in female animals. Food consumption was decreased in 300 and 1000 mg/kg/day test groups and increased in 1000 mg/kg/day recovery group in male rats and a decrease in food consumption was noted in 1000 mg/kg/day test group and an increase was noted in 1000 mg/kg/day recovery group in female rats.   Male rats showed an increase in the RET at 300, 1000 mg/kg/day and Recovery 1000 mg/kg/day, increase in the MCV at 1000mg/kg/day, increase in the MCV at Recovery at 1000 mg/kg/day  and decrease in the MCHC at recovery at 1000 mg/kg/day while female rats showed a decrease in the RBC at 1000 mg/kg/day and Recovery at 1000 mg/kg/day, decrease in the Hgb at 1000 mg/kg/day and Recovery  at 1000 mg/kg/day concentration, decrease in the MCHC at 1000 mg/kg/day and  an increase in the MCV, MCH and RET at 1000 mg/kg/day. An increase in the TCho, PL and ALT at 1000 mg/kg/d and a decrease in K at 1000 mg/kg/ day dose level was noted in male animals and an increase in the TP at 300 and 1000 mg/kg/day, increase in the Alb at 300 and 1000 mg/kg/day, increase in the TCho,PL and ALP at 1000 mg/kg/day, increase in the AST at Recovery 1000 mg/kg/day, increase in the ALT at 1000 mg/kg/day and Recovery at  1000 mg/kg/day and an increase in the TBil at 1000 mg/kg/day dose level was noted in female animals.   Male rats showed an increase in the absolute and relative kidney weight at 300 and 1000 mg/kg/day, increase in the absolute and relative spleen weight at 300 and 1000 mg/kg/day, increase in the absolute and relative liver weight at 1000 mg/kg/day, increase in the absolute and relative adrenal weight at 1000 mg/kg/day  concentration and Recovery  at 1000 mg/kg/day, increase in the relative weight of testis at 1000 mg/kg/day, increase in the relative brain weight at 1000 mg/kg/day and Recovery at  1000 mg/kg/day and a decrease in the absolute epididymides weight at 1000 mg/kg/day and at Recovery 1000 mg/kg/day dose levels. Female rats showed an increase in the absolute and relative kidney weight at 300, 1000 mg/kg/day and Recovery 1000 mg/kg/day (tendency), increase in the relative weight of liver at 300 and 1000 mg/kg/day, increase in the relative brain weight at 300 and 1000 mg/kg/day, increase in the absolute and relative spleen weight at 1000 mg/kg/day and an increase in the relative heart weight at 1000 mg/kg/day.   Centrilobular hypertrophy of hepatocytes in the liver in 1000 mg/kg/day, inflammatory cell nest in the liver at Recovery 1000 mg/kg/day, deposit of hemosiderin in the spleen at 1000 mg/kg/day and Recovery at 1000 mg/kg/day, increase in the extramedullary hematopoietic in the spleen (Recovery 1000 mg/kg/day), vacuolization in the seminiferous tubule, germ cell necrosis and multinucleated giant cell formation in the testis (1000mg/kg/day and Recovery 1000 mg/kg/day), inflammatory infiltration in the mucosa and the lamina propria of small and large intestines at 1000 mg/kg/day was noted in male rats and an increase in the extramedullary hematopoiesis in the liver at 1000 mg/kg/day, inflammatory cell nest in the liver at Recovery 1000 mg/kg/day, deposit of hemosiderin in the spleen at 1000 mg/kg/day and Recovery at 1000 mg/kg/day, increase in the extramedullary hematopoiesis in the spleen at 1000 mg/kg/day, inflammation in forestomach at 1000 mg/kg/day, squamous cell hyperplasia in forestomach at 300 and 1000 mg/kg/day and atrophy of the thymus at 300 and 1000 mg/kg/day was observed in female rats.   Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for 2,3,5 Trimethylphenol upon repeated oral exposure in male and female Crl:CD (SD) rats is 100 mg/Kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e7bd621-9531-467a-b1af-75bc1f7ecbdc/documents/12e1ebf2-7b3f-457f-a540-3985d5d17808_dde0d894-a1e5-49b0-bb0e-3ae1ab7ee378.html,,,,,, "2,3,5-trimethylphenol",697-82-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e7bd621-9531-467a-b1af-75bc1f7ecbdc/documents/12e1ebf2-7b3f-457f-a540-3985d5d17808_dde0d894-a1e5-49b0-bb0e-3ae1ab7ee378.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2,3,5-trimethylphenol",697-82-5," LD50 was estimated to be 2582 mg/kg bw when Gassner male and female rats were orally exposed with 2,3,5-trimethylphenol ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e7bd621-9531-467a-b1af-75bc1f7ecbdc/documents/877a8287-5efe-4791-a2bc-293c4e5579ea_dde0d894-a1e5-49b0-bb0e-3ae1ab7ee378.html,,,,,, "2,3,5-trimethylphenol",697-82-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e7bd621-9531-467a-b1af-75bc1f7ecbdc/documents/877a8287-5efe-4791-a2bc-293c4e5579ea_dde0d894-a1e5-49b0-bb0e-3ae1ab7ee378.html,,oral,LD50,"2,582 mg/kg bw",no adverse effect observed, "2,3,6-trimethyl-p-anisaldehyde",54344-92-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Method OECD 423 - experimental study LD50 > 2000 mg/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cec21fb6-53e1-431c-a47c-4578a111d958/documents/78f0675d-d31a-4c0b-b532-467152e7ffbf_13460528-6e0c-46ff-af4b-ecaa1f4f12c1.html,,,,,, "2,3-bis((2-mercaptoethyl)thio)-1-propanethiol",131538-00-6,NOAEL oral subacute toxicity = 50 mg/kg bw ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c7da50e-3c6c-4703-a473-fded3a7099b5/documents/ca03c3d9-00dd-4552-a8d7-b0af660731a1_5a0f4f58-6caa-4087-86d0-3951c561dc36.html,,,,,, "2,3-bis((2-mercaptoethyl)thio)-1-propanethiol",131538-00-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c7da50e-3c6c-4703-a473-fded3a7099b5/documents/ca03c3d9-00dd-4552-a8d7-b0af660731a1_5a0f4f58-6caa-4087-86d0-3951c561dc36.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "2,3-bis((2-mercaptoethyl)thio)-1-propanethiol",131538-00-6,"Oral (OECD 401): LD50, rat = 3577 mg/kg bw Dermal (OECD 402 limit test): LD50, rabbit > 2000 mg/kg bw Inhalation (OECD 403 limit test): LD50, rat >4.8 mg/L ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c7da50e-3c6c-4703-a473-fded3a7099b5/documents/2f54da6a-eac6-42ff-9946-b68d334b948c_5a0f4f58-6caa-4087-86d0-3951c561dc36.html,,,,,, "2,3-bis((2-mercaptoethyl)thio)-1-propanethiol",131538-00-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c7da50e-3c6c-4703-a473-fded3a7099b5/documents/2f54da6a-eac6-42ff-9946-b68d334b948c_5a0f4f58-6caa-4087-86d0-3951c561dc36.html,,oral,LD50,"3,577 mg/kg bw",no adverse effect observed, "2,3-bis((2-mercaptoethyl)thio)-1-propanethiol",131538-00-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c7da50e-3c6c-4703-a473-fded3a7099b5/documents/2f54da6a-eac6-42ff-9946-b68d334b948c_5a0f4f58-6caa-4087-86d0-3951c561dc36.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,3-bis((2-mercaptoethyl)thio)-1-propanethiol",131538-00-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c7da50e-3c6c-4703-a473-fded3a7099b5/documents/2f54da6a-eac6-42ff-9946-b68d334b948c_5a0f4f58-6caa-4087-86d0-3951c561dc36.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "2',3-bis[[3-[3,5-di-tert-butyl-4-hydroxyphenyl]propionyl]]propionohydrazide",32687-78-8,"In the key study (90d feeding in rat) the following observations were recorded: parameters of hematology and blood chemistry investigated at week 14 showed minimal variations in thrombocytes, sodium, inorganic phosphorus, protein, albumin and globulin concentrations in females of the high dose (10000 ppm). The toxicological significance of these findings is doubtful. A slight, but significant decrease of the liver weight in treated male rats of groups 3 and 4 (2000 and 10000 ppm) and a slight decrease of testes weight in treated male group 4. No correlate was identified in histological investigations and these effects were considered to be of no toxicological relevance. Males given 2000 and 10000 ppm additionally showed an increase of nonspecific, minimal inflammatory cell infiltration in the liver. The NOEL was derived at 400 ppm and the NOAEL at 10000 ppm (624 mg/kg). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d991f91-a240-4ae5-b57c-bed33ab8f1bb/documents/IUC5-6af7e610-6eb5-41bd-9320-4bb54251cb31_c2da9a8b-15dd-47f2-9714-9204edb99e55.html,,,,,, "2',3-bis[[3-[3,5-di-tert-butyl-4-hydroxyphenyl]propionyl]]propionohydrazide",32687-78-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d991f91-a240-4ae5-b57c-bed33ab8f1bb/documents/IUC5-6af7e610-6eb5-41bd-9320-4bb54251cb31_c2da9a8b-15dd-47f2-9714-9204edb99e55.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,624 mg/kg bw/day,,rat "2',3-bis[[3-[3,5-di-tert-butyl-4-hydroxyphenyl]propionyl]]propionohydrazide",32687-78-8,The test article is virtually non-toxic after a single ingestion with an oral LD50 of greater than 7000 mg/kg bodyweight. The substance appears also not toxic after short-term inhalation. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d991f91-a240-4ae5-b57c-bed33ab8f1bb/documents/IUC5-26d123f1-210a-4065-b6e7-3948291160e1_c2da9a8b-15dd-47f2-9714-9204edb99e55.html,,,,,, "2',3-bis[[3-[3,5-di-tert-butyl-4-hydroxyphenyl]propionyl]]propionohydrazide",32687-78-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d991f91-a240-4ae5-b57c-bed33ab8f1bb/documents/IUC5-26d123f1-210a-4065-b6e7-3948291160e1_c2da9a8b-15dd-47f2-9714-9204edb99e55.html,,oral,LD50,"7,000 mg/kg bw",no adverse effect observed, "2',3-bis[[3-[3,5-di-tert-butyl-4-hydroxyphenyl]propionyl]]propionohydrazide",32687-78-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d991f91-a240-4ae5-b57c-bed33ab8f1bb/documents/IUC5-26d123f1-210a-4065-b6e7-3948291160e1_c2da9a8b-15dd-47f2-9714-9204edb99e55.html,,inhalation,LC50,110 mg/m3,no adverse effect observed, "2,3-dichloro-5-trifluoromethylpyridine",69045-84-7,"Two repeated dose toxicity studies are available, a sub-acute and a sub-chronic study, both with exposure via the oral route (gavage). Both studies were performed according to the relevant guidelines and under GLP conditions (Klimisch 1 studies). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83e5a0d5-b883-4dbc-965b-de2d7768b4ea/documents/08ef3f36-a3db-4d7b-8078-6d8bf3c337b4_7d8ca309-c186-4405-a20a-e47a41b9fca0.html,,,,,, "2,3-dichloro-5-trifluoromethylpyridine",69045-84-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83e5a0d5-b883-4dbc-965b-de2d7768b4ea/documents/08ef3f36-a3db-4d7b-8078-6d8bf3c337b4_7d8ca309-c186-4405-a20a-e47a41b9fca0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,>= 150 mg/kg bw/day,,rat "2,3-dichloro-5-trifluoromethylpyridine",69045-84-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83e5a0d5-b883-4dbc-965b-de2d7768b4ea/documents/08ef3f36-a3db-4d7b-8078-6d8bf3c337b4_7d8ca309-c186-4405-a20a-e47a41b9fca0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,>= 50 mg/kg bw/day,,rat "2,3-dichloro-5-trifluoromethylpyridine",69045-84-7,"Reliable studies are available for acute toxicity via the oral, dermal and inhalation route.  ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83e5a0d5-b883-4dbc-965b-de2d7768b4ea/documents/af6661c3-a505-4a0b-80d8-b98708bb35ef_7d8ca309-c186-4405-a20a-e47a41b9fca0.html,,,,,, "2,3-dichloro-5-trifluoromethylpyridine",69045-84-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83e5a0d5-b883-4dbc-965b-de2d7768b4ea/documents/af6661c3-a505-4a0b-80d8-b98708bb35ef_7d8ca309-c186-4405-a20a-e47a41b9fca0.html,,oral,LD50,"1,879 mg/kg bw",adverse effect observed, "2,3-dichloro-5-trifluoromethylpyridine",69045-84-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83e5a0d5-b883-4dbc-965b-de2d7768b4ea/documents/af6661c3-a505-4a0b-80d8-b98708bb35ef_7d8ca309-c186-4405-a20a-e47a41b9fca0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,3-dichloro-5-trifluoromethylpyridine",69045-84-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83e5a0d5-b883-4dbc-965b-de2d7768b4ea/documents/af6661c3-a505-4a0b-80d8-b98708bb35ef_7d8ca309-c186-4405-a20a-e47a41b9fca0.html,,inhalation,LC50,> 1.75 mg/L,adverse effect observed, "2,3-dichlorobuta-1,3-diene",1653-19-6,"There are no standard studies on the repeated dose toxicity of 2,3 dichloro-1,3 butadiene following oral or dermal exposures. No effects attributed to 2,3 dichloro-1,3 butadiene were observed in a sub-acute repeated dose inhalation study in which rats were exposed to vapours at 0.4 mg/l. In a one-generation, repeated dose inhalation exposures to 2,3 dichloro-1,3 butadiene at 0, 1, 5 or 50 ppm, A NOEL of 5 ppm (25 mg/m3) was reported based on observations of decreased body weight, weight gain and food consumption parameters and degeneration of the nasal olfactory epithelium at 50 ppm. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/433c072e-c5a4-4f54-a3d6-485d822dc576/documents/IUC5-bd621b4f-d737-48e6-af80-70e5713cea57_773e10b0-deea-4c38-8cf7-c1ed4b09d739.html,,,,,, "2,3-dichlorobuta-1,3-diene",1653-19-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/433c072e-c5a4-4f54-a3d6-485d822dc576/documents/IUC5-bd621b4f-d737-48e6-af80-70e5713cea57_773e10b0-deea-4c38-8cf7-c1ed4b09d739.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,25 mg/m3,,rat "2,3-dichlorobuta-1,3-diene",1653-19-6,"2,3-Dichloro-1,3-butadiene is moderately toxic after acute inhalation exposure with an LC50 of 2080 mg/m3/4 h in rats. There are no LD50 data available for the dermal route but studies in rats, mice, and rabbits provide evidence for systemic toxicity of 2,3-dichloro-1,3-butadiene after dermal application. The oral LD50 has been determined as 222 mg/kg for rats and 110 mg/kg for mice; target organs are the stomach, spleen, liver, and kidney. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/433c072e-c5a4-4f54-a3d6-485d822dc576/documents/IUC5-f6c51c5d-c752-4040-ada7-4fe9d81abff9_773e10b0-deea-4c38-8cf7-c1ed4b09d739.html,,,,,, "2,3-dichlorobuta-1,3-diene",1653-19-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/433c072e-c5a4-4f54-a3d6-485d822dc576/documents/IUC5-f6c51c5d-c752-4040-ada7-4fe9d81abff9_773e10b0-deea-4c38-8cf7-c1ed4b09d739.html,,oral,LD50,222 mg/kg bw,, "2,3-dichlorobuta-1,3-diene",1653-19-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/433c072e-c5a4-4f54-a3d6-485d822dc576/documents/IUC5-f6c51c5d-c752-4040-ada7-4fe9d81abff9_773e10b0-deea-4c38-8cf7-c1ed4b09d739.html,,inhalation,LC50,"2,080 mg/m3",, "2,3-Difluor-1-propoxy-4-[trans-4-(trans-4-propylcyclohexyl)- cyclohexyl]-benzene",473257-14-6, Read Across: LD50 > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1be1d62d-0f8b-470d-a8dc-8f0b7a995a0b/documents/92d9f246-a414-4791-b643-2f63a58830b1_196e0418-dea0-498b-bfef-64ea16f218c1.html,,,,,, "2,3-Difluor-1-propoxy-4-[trans-4-(trans-4-propylcyclohexyl)- cyclohexyl]-benzene",473257-14-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1be1d62d-0f8b-470d-a8dc-8f0b7a995a0b/documents/92d9f246-a414-4791-b643-2f63a58830b1_196e0418-dea0-498b-bfef-64ea16f218c1.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,3-difluoro-1-methoxy-4-[(trans,trans)-4'-propyl[1,1'-bicyclohexyl]-4-yl]-benzene",431947-34-1," Read Across Information: LD50 (oral, rat) > 2000 mg/kg bw ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06b4b444-11bd-42e4-a68a-9421b3dca71d/documents/dc07564c-aa64-406f-b35f-95879c6dedaf_4c13be60-3efb-4d2c-8eae-f271e690d30f.html,,,,,, "2,3-difluoro-1-methoxy-4-[(trans,trans)-4'-propyl[1,1'-bicyclohexyl]-4-yl]-benzene",431947-34-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06b4b444-11bd-42e4-a68a-9421b3dca71d/documents/dc07564c-aa64-406f-b35f-95879c6dedaf_4c13be60-3efb-4d2c-8eae-f271e690d30f.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,3-difluoro-1-propoxy-4-[4-(trans-4-propylcyclohexyl)-1-cyclohexen-1-yl]-benzene",1003218-40-3," In an oral acute toxicity study performed in rats with the structural analogue substance no mortality, no body weight change and no signs of toxicity have been observed. The LD50 (male/female) is > 2000 mg/kg bw (reference 7.2.1 -1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c869b3ab-d2d5-43d1-998b-a733f00043dd/documents/7b22e5c9-19d4-49fc-8a98-572a3202f611_8a02178c-fbaa-4f88-92a9-1d5a54cfe749.html,,,,,, "2,3-difluoro-1-propoxy-4-[4-(trans-4-propylcyclohexyl)-1-cyclohexen-1-yl]-benzene",1003218-40-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c869b3ab-d2d5-43d1-998b-a733f00043dd/documents/7b22e5c9-19d4-49fc-8a98-572a3202f611_8a02178c-fbaa-4f88-92a9-1d5a54cfe749.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,3-dihydro-1,4-dihydroxyanthraquinone",40498-13-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f0d1089-ae29-4aa1-b90f-90af5af6c1a1/documents/03524019-3ce0-4546-a6e5-cf075e61f27b_5275d32d-abe5-4498-b8a6-ce301ce85f01.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2,3-dihydroxypropyl 12-hydroxyoctadecanoate",6284-43-1,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c44ae2b9-2028-4b78-98ee-2cfffb7a4143/documents/IUC5-100d09c9-bec5-46ea-87dd-82f55c82d3ca_c9828c8e-6bf5-48d6-a752-07ac3b41614f.html,,,,,, "2,3-dihydroxypropyl 12-hydroxyoctadecanoate",6284-43-1,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c44ae2b9-2028-4b78-98ee-2cfffb7a4143/documents/IUC5-694f4908-af3e-4729-afa2-3635b21d3d49_c9828c8e-6bf5-48d6-a752-07ac3b41614f.html,,,,,, "2,3-dimethylbutane",79-29-8,Acute toxicity oral LD50 >16750 mg/kg in rats (OECD TG 401) Acute toxicity inhalation LC50 >259354 mg/m3 in rats (OECD TG 403)   Acute toxicity dermal LD50 >3350 mg/kg in rabbits (OECD TG 402) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1077719b-fb83-4e4c-aed6-02d70421efde/documents/c5c6dfd5-ce0f-47e4-ac4e-74318996dcf1_5bc73fd1-c6da-4f78-9a3f-4d6343507470.html,,,,,, "2,3-dimethylbutane",79-29-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1077719b-fb83-4e4c-aed6-02d70421efde/documents/c5c6dfd5-ce0f-47e4-ac4e-74318996dcf1_5bc73fd1-c6da-4f78-9a3f-4d6343507470.html,,oral,LD50,"> 16,750 mg/kg bw",no adverse effect observed, "2,3-dimethylbutane",79-29-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1077719b-fb83-4e4c-aed6-02d70421efde/documents/c5c6dfd5-ce0f-47e4-ac4e-74318996dcf1_5bc73fd1-c6da-4f78-9a3f-4d6343507470.html,,dermal,LD50,"> 3,350 mg/kg bw",no adverse effect observed, "2,3-dimethylbutane",79-29-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1077719b-fb83-4e4c-aed6-02d70421efde/documents/c5c6dfd5-ce0f-47e4-ac4e-74318996dcf1_5bc73fd1-c6da-4f78-9a3f-4d6343507470.html,,inhalation,LC50,"> 259,354 mg/m3",no adverse effect observed, "2,3-epoxypropyl isopropyl ether",4016-14-2,"Repeated Dose Toxicity: Reproductive toxicity / repeated dose screening study oral (gavage), Wistar rat m/f, 0, 100, 300, 600 mg/kg, 43/44 days (males) and ca. 43 days (females), OECD 422, GLP: NOAEL = 100 mg/kg (female, general toxicity, based on increased corpora lutea and being in metestrus or diestrus) NOAEL = 300 mg/kg (male, general toxicity, based on body weight (gain) and macroscopic and microscopic changes in the stomach) LOAEL = 100 mg/kg (female, reproductive toxicity)   Repeated Dose Toxicity: Range finding study oral (gavage), Wistar rat m/f, 0, 75, 250, 500 mg/kg: NOAEL = 500 mg/kg (m/f, based on mortality, clinical signs) NOEL = 250 mg/kg (m/f, based on initial effect on body weight performance)   Repeated Dose Toxicity: Subchronic inhalation toxicity, male Long-Evans rats, 400 ppm (vapour), 7 hours daily, 5 days per week for 10 weeks: NOEC = 400 ppm (based on Body/organ weight ratios liver, kidney; mortality) LOEC = 400 ppm (based on decreased bodyweight gain, hemoglobin increase)   Repeated Dose Toxicity: Subchronic dermal toxicity, application of 0.2 ml isopropyl glycidyl ether (about 90 mg/kg) to the skin of a California Albino or New Zealand White rabbit, once daily, 5 times weekly on a total of 7 days until the degree of eschar formation at the site made further applications undesirable, or the animals showed signs of systemic toxicity: reduction in body weight gain and skin erythema ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac883d7c-c5bd-4c74-b5c6-e83701507785/documents/2d0f058b-a4fa-48e4-8a59-5b0b6128c110_cbdd35c5-6526-4203-a973-1cb5affb6a0f.html,,,,,, "2,3-epoxypropyl isopropyl ether",4016-14-2,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac883d7c-c5bd-4c74-b5c6-e83701507785/documents/2d0f058b-a4fa-48e4-8a59-5b0b6128c110_cbdd35c5-6526-4203-a973-1cb5affb6a0f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2,3-epoxypropyl isopropyl ether",4016-14-2,"Acute Toxicity: Oral, rat, LD50 = 4200 mg/kg (RTECS)Acute Toxicity: Oral, mouse, LD50 = 1300 mg/kg (RTECS)Acute Toxicity: Oral, LD50 = 4200 mg/kg (rat), LD50 = 1300 (mouse) (Patty´s Industrial Hygiene and Toxicology)Acute Toxicity: Acute study oral (gavage), rat (Long-Evans), male, similar to OECD 401: LD50 = 4200 mg/kgAcute Toxicity: Acute study oral (gavage), mouse (Webster), male, similar to OECD 401: LD50 = 1300 mg/kgAcute Toxicity: Inhalation, rat, 8h exposure, LC50 = 1100 ppm (RTECS)Acute Toxicity: Inhalation, mouse, 4h exposure, LC50 = 1500 ppm (RTECS)Acute Toxicity: Inhalation, LC50 = 1100 ppm (rat, 8h exposure), LC50 = 1500 ppm (mouse, 4h exposure) (Patty´s Industrial Hygiene and Toxicology)Acute Toxicity: Acute inhalation study, whole body, 8h exposure, rat (Long-Evans), male, similar to OECD 403: LC50 = 1100 ppm ≙ 5.226 mg/LAcute Toxicity: Acute inhalation study, whole body, 4h exposure, mouse (Webster), male, similar to OECD 403: LC50 = 1500 ppm ≙ 7.126 mg/LAcute Toxicity: Dermal, rat, citation, LD50 > 2000 mg/kg bwAcute Toxicity: Dermal, rabbit, LD50 = 9650 mg/kg (RTECS)Acute Toxicity: Dermal, California Albino or New Zealand White rabbit, occlusive, similar to OECD 402, LD50 = 9650 mg/kg ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac883d7c-c5bd-4c74-b5c6-e83701507785/documents/IUC5-fa6d574b-356b-4021-b66b-80dec5783f12_cbdd35c5-6526-4203-a973-1cb5affb6a0f.html,,,,,, "2,3-epoxypropyl isopropyl ether",4016-14-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac883d7c-c5bd-4c74-b5c6-e83701507785/documents/IUC5-fa6d574b-356b-4021-b66b-80dec5783f12_cbdd35c5-6526-4203-a973-1cb5affb6a0f.html,,oral,LD50,"1,300 mg/kg bw",adverse effect observed, "2,3-epoxypropyl isopropyl ether",4016-14-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac883d7c-c5bd-4c74-b5c6-e83701507785/documents/IUC5-fa6d574b-356b-4021-b66b-80dec5783f12_cbdd35c5-6526-4203-a973-1cb5affb6a0f.html,,dermal,LD50,"9,650 mg/kg bw",no adverse effect observed, "2,3-epoxypropyl isopropyl ether",4016-14-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac883d7c-c5bd-4c74-b5c6-e83701507785/documents/IUC5-fa6d574b-356b-4021-b66b-80dec5783f12_cbdd35c5-6526-4203-a973-1cb5affb6a0f.html,,inhalation,LC50,"5,226 mg/m3",adverse effect observed, "2,3-epoxypropyl neodecanoate",26761-45-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6fb81614-597f-40fa-8036-fa3986740cf6/documents/IUC5-f1443149-a7e8-4ba2-a2be-fabddefa7950_0ca6b54f-884e-4fc9-bafa-5ea080d10441.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2,3-epoxypropyl neodecanoate",26761-45-5,"Acute toxicity study data was available for 2,3-epoxypropyl neodecanoate for all three routes of administration: oral, dermal and inhalation. The findings demonstrate that 2,3-epoxypropyl neodecanoate is not acutely toxic by these three routes of administration. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fb81614-597f-40fa-8036-fa3986740cf6/documents/IUC5-202ec094-ea22-4eb9-a994-1135bb3a2fd8_0ca6b54f-884e-4fc9-bafa-5ea080d10441.html,,,,,, "2,3-Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol",154565-28-3, An OECD 422 screening study is available for the submission substance and reports a NOAEL of 1000 mg/kg bw/d. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3424acdd-c1ec-43f6-953d-0567e8c84507/documents/f329f4d1-1e71-4b17-bb23-99fbe3e42158_42f12ec0-05fe-4ebb-9bdd-b7336731a157.html,,,,,, "2,3-Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol",154565-28-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3424acdd-c1ec-43f6-953d-0567e8c84507/documents/f329f4d1-1e71-4b17-bb23-99fbe3e42158_42f12ec0-05fe-4ebb-9bdd-b7336731a157.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,3-Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol",154565-28-3," A modern, GLP- and guideline (OECD 425) compliant study of acute oral toxicity is available for the submission substance. Waivers are proposed for acute dermal toxicity (based on the very low acute oral toxicity) and for acute inhalation toxicity (based on the lack of exposure potential). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3424acdd-c1ec-43f6-953d-0567e8c84507/documents/1fbe4c4f-7018-4539-80aa-2c6d1020bd69_42f12ec0-05fe-4ebb-9bdd-b7336731a157.html,,,,,, "2,3-Epoxypropyl neodecanoate, oligomeric reaction products with cyclohexane-1,2-dicarboxylic anhydride and propylidenetrimethanol",154565-28-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3424acdd-c1ec-43f6-953d-0567e8c84507/documents/1fbe4c4f-7018-4539-80aa-2c6d1020bd69_42f12ec0-05fe-4ebb-9bdd-b7336731a157.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid",157348-58-8,"In a dose-range-finding study, the test item was administered orally to male and female rats at dose levels of 100, 300 or 1000 mg/kg b.w./day for 2 weeks.Under the present test conditions, the no-observed-adverse-effect level (NOAEL) was 300 mg test item/kg b.w./day. Based on the data obtained in this dose range finding study, the following dose levels are suggested for the main study: Group 1: Control (vehicle), Group 2: 75 mg test item/kg b.w./day, p.o, Group 3: 225 mg test item/kg b.w./day, p.o, Group 4: 750 mg/kg b.w./day, p.o. In the repeated dose oral toxicity study according to OECD 422, the test item was administered orally to rats at dose levels of 75, 225 or 750/600/450 mg test item/kg b.w./day. The high dose level had to be stepwise reduced as of test day 29 and 42 due to mortality. In order to investigate the reversibility of observed signs of general toxicity during the main study, a toxicity study with a recovery period was additionally performed. Under the conditions of this repeated dose toxicity study the no-observed-adverse-effect level (NOAEL) for the general toxicity for systemic toxicity is considered to be 225 mg test item/kg b.w./day, p.o. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a2cdb9f-ca68-495e-a9d8-803b9a500ad4/documents/d7de9cf1-717e-4137-b30b-a13c08ef21a8_e2beccaa-4e6a-48ee-8a1e-58102c358629.html,,,,,, "2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid",157348-58-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a2cdb9f-ca68-495e-a9d8-803b9a500ad4/documents/d7de9cf1-717e-4137-b30b-a13c08ef21a8_e2beccaa-4e6a-48ee-8a1e-58102c358629.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,225 mg/kg bw/day,,rat "2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid",157348-58-8," Under the conditions of the study in rats according to OECD 423 the acute toxicity after oral application is greater than 2000 mg/kg bw for the test item (BSL Bioservice, 2004). Furthermore, an acute inhalation toxicity study was conducted in rats according to OECD 403 revealed LC50 of greater than 5.03 mg test item/L air/4 hours (LPT, 2016). An acute dermal toxicity study is not available for the test substance. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a2cdb9f-ca68-495e-a9d8-803b9a500ad4/documents/fad18d0d-ea78-4eda-a529-52f34f8f6fc5_e2beccaa-4e6a-48ee-8a1e-58102c358629.html,,,,,, "2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid",157348-58-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a2cdb9f-ca68-495e-a9d8-803b9a500ad4/documents/fad18d0d-ea78-4eda-a529-52f34f8f6fc5_e2beccaa-4e6a-48ee-8a1e-58102c358629.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,3-Epoxypropyl neodecanoate, oligomeric reaction products with phosphorous acid",157348-58-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a2cdb9f-ca68-495e-a9d8-803b9a500ad4/documents/fad18d0d-ea78-4eda-a529-52f34f8f6fc5_e2beccaa-4e6a-48ee-8a1e-58102c358629.html,,inhalation,LC50,"5,030 mg/m3",no adverse effect observed, "2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid",98362-33-5," In a 90-day gavage study with rats, the experimental no-observed-adverse-effect-level (NOAEL) was 1000 mg/test item/kg b.w./day by daily oral administration (LPT, 2016). All changes observed during the main study had completely subsided in all male and female previously high-dosed animals at the end of the recovery period. Histopathology still revealed morphological lesions in the kidneys of the male high dosed animals in form of tubular basophilia, tubular dilation, cystic tubular degeneration, and lymphocytic infiltration. The test item related changes in the kidneys of the male animals are classified as alpha 2u-globulin nephropathy. They are rat specific and not relevant in man. Under the conditions of the subacute inhalation study no adverse effects occurred in the low and mid concentration groups. Therefore, the mid concentration of 202 mg/m3 (actual concentration measured by gravimetry) was the No-Observed-Adverse-Effect-Concentration (NOAEC) for systemic effects of the test item. Furthermore, this 14 day repeated dose inhalation study reveal no indications for local effects up to concentrations of 2032 mg/m3. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/686f0e16-61c6-4c43-8992-c8ca95967461/documents/b326f754-f720-44b4-b8ff-93ce84e188ae_e9f4b66e-5ced-40d2-95a1-9917af6608d4.html,,,,,, "2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid",98362-33-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/686f0e16-61c6-4c43-8992-c8ca95967461/documents/b326f754-f720-44b4-b8ff-93ce84e188ae_e9f4b66e-5ced-40d2-95a1-9917af6608d4.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,202 mg/m3,,rat "2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid",98362-33-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/686f0e16-61c6-4c43-8992-c8ca95967461/documents/b326f754-f720-44b4-b8ff-93ce84e188ae_e9f4b66e-5ced-40d2-95a1-9917af6608d4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid",98362-33-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/686f0e16-61c6-4c43-8992-c8ca95967461/documents/b326f754-f720-44b4-b8ff-93ce84e188ae_e9f4b66e-5ced-40d2-95a1-9917af6608d4.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"2,032 mg/m3",no adverse effect observed,rat "2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid",98362-33-5,"2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid is of low oral and inhalation toxicity with an oral LD50 (rat) of > 10000 mg/kg bw (OECD 401, Hüls AG, 1985) and an inhalation LC50 of > 1900 mg/ m3 (OECD 403, Seibersdorf 2011) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/686f0e16-61c6-4c43-8992-c8ca95967461/documents/IUC5-7cea973d-9f71-45a8-a8af-b04a73694ec4_e9f4b66e-5ced-40d2-95a1-9917af6608d4.html,,,,,, "2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid",98362-33-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/686f0e16-61c6-4c43-8992-c8ca95967461/documents/IUC5-7cea973d-9f71-45a8-a8af-b04a73694ec4_e9f4b66e-5ced-40d2-95a1-9917af6608d4.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "2,3-Epoxypropyl neodecanoate, oligomeric reaction products with toluene-4-sulfonic acid",98362-33-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/686f0e16-61c6-4c43-8992-c8ca95967461/documents/IUC5-7cea973d-9f71-45a8-a8af-b04a73694ec4_e9f4b66e-5ced-40d2-95a1-9917af6608d4.html,,inhalation,LC50,"1,900 mg/m3",no adverse effect observed, "2,4,4-trimethylpentene",25167-70-8,"Adequate information is available to characterise the hazards of this substance following repeated exposure, with a NOEL of 300mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/659ef23c-d90e-4906-b861-c9fb20e1ff56/documents/IUC5-9cddc453-7bd4-4c18-9c38-3a81597b44c7_fed25481-3b52-4540-8bb7-86d55f79b22d.html,,,,,, "2,4,4-trimethylpentene",25167-70-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/659ef23c-d90e-4906-b861-c9fb20e1ff56/documents/IUC5-9cddc453-7bd4-4c18-9c38-3a81597b44c7_fed25481-3b52-4540-8bb7-86d55f79b22d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2,4,4-trimethylpentene",25167-70-8,"The studies available for 2,4,4-trimethylpentene indicate a substance of low oral and dermal toxicity. Information from diisobutylene (a less pure form) indicate that low acute toxicity by inhalation is also likely for 2,4,4-trimethylpentene. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/659ef23c-d90e-4906-b861-c9fb20e1ff56/documents/IUC5-ac25208b-9d4d-4e21-9155-4b7589fb1881_fed25481-3b52-4540-8bb7-86d55f79b22d.html,,,,,, "2,4,4-trimethylpentene",25167-70-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/659ef23c-d90e-4906-b861-c9fb20e1ff56/documents/IUC5-ac25208b-9d4d-4e21-9155-4b7589fb1881_fed25481-3b52-4540-8bb7-86d55f79b22d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,4,4-trimethylpentene",25167-70-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/659ef23c-d90e-4906-b861-c9fb20e1ff56/documents/IUC5-ac25208b-9d4d-4e21-9155-4b7589fb1881_fed25481-3b52-4540-8bb7-86d55f79b22d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,4,4-trimethylpentene",25167-70-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/659ef23c-d90e-4906-b861-c9fb20e1ff56/documents/IUC5-ac25208b-9d4d-4e21-9155-4b7589fb1881_fed25481-3b52-4540-8bb7-86d55f79b22d.html,,inhalation,LC50,"19,171 mg/m3",no adverse effect observed, "2,4,5-trichloroaniline",636-30-6,"Trichloroaniline was administered for 14 days orally to rats at doses of 60 to 1000 mg/kg in a limited study. The reduced study design of this repeated dose study has only an orientating character. No haematological and clinical chemistry data were obtained in this study. Organ weights were only determined of liver, spleen, kidneys, testes and ovaries. Histopathological examination was only performed in the spleen and the liver.However, no mortality occurred during the 14 day dosing period. The only clinical sign observed was the rough fur of three females of the high dose group beginning during the second treament week.At 1000 mg/kg bw food consumption was comparable to control animals, the water consumption increased. Changes in the spleen of both sexes were described. Spleens were swollen (based on the increased blood content) and extramedullary haematopoesis and haematosiderosis were observed. The liver of one female of the 1000 mg/kg bw dose group showed a slight Kupffer cell siderosis. Liver weight (relative and absolute) was increased.At 250 mg/kg bw a decreased body weight gain was noted (i.e. females 8% and 9% in the 250 and 1000 mg/kg dose group, respectively. At males of these dosing groups the decrease of body weight w as 4%). Food consumption of the 250mg/kg dose group was comparable to control animals. Females of this dose group showed changes in the spleen (haematosiderosis).At 60 mg/kg bw animals showed a body weight gain comparable to the control animals. At this dose group there were no other findings.The NOAEL is determined as 60mg/kg bw (based on no effects seen in the spleen and liver). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb53f8d2-fa2d-4ea0-a0cc-fb960f752715/documents/IUC5-fd2f8e13-0144-4bb8-8891-9358227daf0c_372fde6a-cc07-454e-ad4f-2437d7fa0034.html,,,,,, "2,4,5-trichloroaniline",636-30-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb53f8d2-fa2d-4ea0-a0cc-fb960f752715/documents/IUC5-fd2f8e13-0144-4bb8-8891-9358227daf0c_372fde6a-cc07-454e-ad4f-2437d7fa0034.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,, "2,4,5-trichloroaniline",636-30-6,"Based on the results of a study on the acute oral toxicity the (LD50) of 2,4,5 -Trichloranilin was determined to be 2093 mg/kg bw (1816- 2413 mg/kg bw) for the male rat.Based on the results of a second acute toxicity study performed with male and female rats the acute oral toxicity (LD50) of 2,4,5 -Trichloranilin was determined to be greater than 5000 mg/kg bw for male and female rats. The results of the acute oral toxicity studies in cats showed the formation of increasing Met-hemoglobin values and Heinz-bodies after a single oral application of 10, 20 and 200mg/kg bw in two independent trials, with one cat (i.e. 10mg/kg bw) and in 2 cats per dose (i.e. 20 and 200mg/kg bw). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb53f8d2-fa2d-4ea0-a0cc-fb960f752715/documents/IUC5-cd0beb8b-4860-4a36-8357-bc5b235d0a9c_372fde6a-cc07-454e-ad4f-2437d7fa0034.html,,,,,, "2,4,5-trichloroaniline",636-30-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb53f8d2-fa2d-4ea0-a0cc-fb960f752715/documents/IUC5-cd0beb8b-4860-4a36-8357-bc5b235d0a9c_372fde6a-cc07-454e-ad4f-2437d7fa0034.html,,oral,discriminating dose,"5,000 mg/kg bw",, "2,4,5-trichloroaniline",636-30-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb53f8d2-fa2d-4ea0-a0cc-fb960f752715/documents/IUC5-cd0beb8b-4860-4a36-8357-bc5b235d0a9c_372fde6a-cc07-454e-ad4f-2437d7fa0034.html,,dermal,discriminating dose,"1,000 mg/kg bw",, "2,4,6,8,10-pentamethylcyclopentasiloxane",6166-86-5," In the key sub-chronic 90-day oral repeated dose toxicity study with 2,4,6,8,10-pentamethylcyclopentasiloxane, conducted according to OECD Test Guideline 408 and in compliance with GLP, the NOAEL for systemic toxicity was concluded to be 150 mg/kg bw/day based on test-item related adverse effects in the urinary system at 400 and 1000 mg/kg bw/day. The findings in this study indicated that the target of toxicity was the urinary system and test-item administration resulted in the early deaths of four high dose group animals. There were a few findings in the urinary tract of some low dose (150 mg/kg bw/day) males but these were minor and there was no calculi-formation and, consequently, they were considered non-adverse. The urinary system findings generally showed some recovery, despite calculi still being present to a similar extent to that observed at the end of the treatment period. There was also an effect on the liver that was considered to represent an adaptive response to treatment that led to a secondary, rodent-specific effect on the thyroid glands as a consequence of disruption of the thyroid hormonal control mechanism (Covance Laboratories Limited, 2020a). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f46e44a0-31c0-4ad6-8a9b-0ffa174988f2/documents/89ca2518-e1d8-4d96-b3a7-0670e7552c6d_7cfb024a-0827-4f08-972d-23e61545aa7a.html,,,,,, "2,4,6,8,10-pentamethylcyclopentasiloxane",6166-86-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f46e44a0-31c0-4ad6-8a9b-0ffa174988f2/documents/89ca2518-e1d8-4d96-b3a7-0670e7552c6d_7cfb024a-0827-4f08-972d-23e61545aa7a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "2,4,6,8,10-pentamethylcyclopentasiloxane",6166-86-5," The key acute oral toxicity study for the registered substance, 2,4,6,8,10-pentamethylcyclopentasiloxane (CAS 6166-86-5), conducted according to OECD Test Guideline 420 and in compliance with GLP, had a LD50 greater than 2000 mg/kg bw (Harlan Laboratories, 2010). The key acute inhalation toxicity study for the mixture of 2,4,6,8,10-pentamethylcyclopentasiloxane (CAS 6166-86-5) and 2,4,6,8-tetramethylcyclotetrasiloxane (CAS 2370-88-9) (approximately 50/50%), conducted according to OECD Test Guideline 403 and in compliance with GLP, had a LC50 greater than 4.9 mg/l. (Dow Corning Corporation, 2002). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f46e44a0-31c0-4ad6-8a9b-0ffa174988f2/documents/520c3599-5483-4d56-bf13-17a7093563cb_7cfb024a-0827-4f08-972d-23e61545aa7a.html,,,,,, "2,4,6,8,10-pentamethylcyclopentasiloxane",6166-86-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f46e44a0-31c0-4ad6-8a9b-0ffa174988f2/documents/520c3599-5483-4d56-bf13-17a7093563cb_7cfb024a-0827-4f08-972d-23e61545aa7a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,4,6,8,10-pentamethylcyclopentasiloxane",6166-86-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f46e44a0-31c0-4ad6-8a9b-0ffa174988f2/documents/520c3599-5483-4d56-bf13-17a7093563cb_7cfb024a-0827-4f08-972d-23e61545aa7a.html,,inhalation,LC50,"4,900 mg/m3",no adverse effect observed, "2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane",2554-06-5,"In the key 90-day repeated dose oral toxicity study with 28-day recovery period with the test substance 2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane (Vi4D4), conducted according to OECD Test Guideline 408 and in compliance with GLP, the systemic NOAEL for male rats was concluded to be greater than 150 mg/kg bw/day based on no adverse effects observed. The systemic NOAEL for female rats was concluded to be equal to 15 mg/kg bw/day based on lower mean number of corpora lutea in females at 50 and 150 mg/kg bw/day, which correlated to lower mean ovary weights and a perturbation of ovarian cycling in these groups (Charles River Laboratories, 2020a, reliability 1).   ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4033483-744b-4790-8b8a-666ae143d30e/documents/32469584-0e42-4c1f-89b3-a8e3972864b8_b74b7f12-f6c2-42e1-be5a-83f3315071f8.html,,,,,, "2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane",2554-06-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4033483-744b-4790-8b8a-666ae143d30e/documents/32469584-0e42-4c1f-89b3-a8e3972864b8_b74b7f12-f6c2-42e1-be5a-83f3315071f8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane",2554-06-5,"There are no acute oral toxicity data for the registered substance, 2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane (CAS 2554-06-5, EC 219-863-1). Therefore, data for the structural analogue, octamethyltetroxatetrasiloxane (D4, CAS 556-67-2) have been read across for these endpoints. Furthermore, read across data from decamethylcyclopentasiloxane (D5, CAS 541-02-6) and hexamethylcyclotrisiloxane (D3, CAS 541-05-9) for the impurities 2,4,6,8,10-pentamethyl-2,4,6,8,10-pentavinylcyclopentasiloxane Vi5-D5 (CAS 17704-22-2; Impurity 1) and 2,4,6-trimethyl-2,4,6-trivinylcyclotrisiloxane Vi3-D3 (CAS 3901-77-7; Impurity 2) have been included as supporting information where available.   In the key study for acute oral toxicity with D4, conducted according to a protocol similar to the now-deleted OECD Test Guideline 401, but prior to GLP, an LD50 value of >5 ml/kg (equivalent to >4800 mg/kg bw) was concluded (Bayer AG, 1979, reliability 2).   In the key acute inhalation toxicity study with Vi4-D4, conducted according to OECD 403 and in compliance with GLP, the reported LC50 (vapour) value is >1.32 mg/l (analytical) (Dow Corning Corporation, 1988, reliability 1).   In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the dermal route (required in Section 8.5.2) does not need to be conducted as reliable data via the oral and inhalation routes are available. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4033483-744b-4790-8b8a-666ae143d30e/documents/66cae607-6f50-4d34-b177-25c8ade477be_b74b7f12-f6c2-42e1-be5a-83f3315071f8.html,,,,,, "2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane",2554-06-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4033483-744b-4790-8b8a-666ae143d30e/documents/66cae607-6f50-4d34-b177-25c8ade477be_b74b7f12-f6c2-42e1-be5a-83f3315071f8.html,,oral,LD50,"4,800 mg/kg bw",no adverse effect observed, "2,4,6,8-tetramethyl-2,4,6,8-tetravinylcyclotetrasiloxane",2554-06-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4033483-744b-4790-8b8a-666ae143d30e/documents/66cae607-6f50-4d34-b177-25c8ade477be_b74b7f12-f6c2-42e1-be5a-83f3315071f8.html,,inhalation,LC50,"1,320 mg/m3",no adverse effect observed, "2,4,6,8-tetramethylcyclotetrasiloxane",2370-88-9," In the key 90-day oral repeated dose toxicity study with 2,4,6,8-tetramethylcyclotetrasiloxane, conducted according to OECD Test Guideline 408 and in compliance with GLP, the NOAEL for systemic effects was determined to be 50 mg/kg bw/day (the lowest dose tested). Exposure to 150 mg/kg bw and 600 mg/kg bw led to reduced body weight gain during the latter part of the treatment period and effects in the urinary system, some of which were persistent after 4-week recovery period, in male and female rats (Covance Laboratories Limited, 2020a). In the key combined repeated dose toxicity study with the reproduction / developmental toxicity screening test with 2,4,6,8-tetramethylcyclotetrasiloxane, conducted according to OECD Test Guideline 422 and in compliance with GLP, the NOAEC for systemic toxicity following inhalation exposure in male and female rats was 100 ppm (equivalent to 984 mg/m3 based on MW of 240.5094 for 2,4,6,8-tetramethylcyclotetrasiloxane) based on bladder stones at 3000/2000 and 1000 ppm and histopathological findings in the urinary tract at 3000/2000 and 1000 ppm (Harlan Laboratories, 2012). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5437edd9-c8f4-4a04-b452-f8e6fedacd32/documents/bd7d0dc3-42c0-4dc6-9d79-4c344ff19606_ab84f897-5315-4695-b3d5-a627639b22c5.html,,,,,, "2,4,6,8-tetramethylcyclotetrasiloxane",2370-88-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5437edd9-c8f4-4a04-b452-f8e6fedacd32/documents/bd7d0dc3-42c0-4dc6-9d79-4c344ff19606_ab84f897-5315-4695-b3d5-a627639b22c5.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,984 mg/m3,,rat "2,4,6,8-tetramethylcyclotetrasiloxane",2370-88-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5437edd9-c8f4-4a04-b452-f8e6fedacd32/documents/bd7d0dc3-42c0-4dc6-9d79-4c344ff19606_ab84f897-5315-4695-b3d5-a627639b22c5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "2,4,6,8-tetramethylcyclotetrasiloxane",2370-88-9,"In the key acute oral toxicity study, conducted according to OECD Test Guideline 420 and in compliance with GLP, a LD50 value greater than 2000 mg/kg bw was reported (Harlan Laboratories, 2010). The key acute inhalation toxicity study for the mixture of 2,4,6,8,10-pentamethylcyclopentasiloxane (CAS 6166-86-5) and 2,4,6,8-tetramethylcyclotetrasiloxane (CAS 2370-88-9) (approximately 50/50%), conducted according to OECD Test Guideline 403 and in compliance with GLP, concluded a LC50 greater than 4.9 mg/l. (Dow Corning Corporation, 2002). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5437edd9-c8f4-4a04-b452-f8e6fedacd32/documents/4c13b62c-d405-47fc-8cc4-f88cd5c14dce_ab84f897-5315-4695-b3d5-a627639b22c5.html,,,,,, "2,4,6,8-tetramethylcyclotetrasiloxane",2370-88-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5437edd9-c8f4-4a04-b452-f8e6fedacd32/documents/4c13b62c-d405-47fc-8cc4-f88cd5c14dce_ab84f897-5315-4695-b3d5-a627639b22c5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,4,6,8-tetramethylcyclotetrasiloxane",2370-88-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5437edd9-c8f4-4a04-b452-f8e6fedacd32/documents/4c13b62c-d405-47fc-8cc4-f88cd5c14dce_ab84f897-5315-4695-b3d5-a627639b22c5.html,,inhalation,LC50,"4,900 mg/m3",adverse effect observed, "2,4,6-triallyloxy-1,3,5-triazine",101-37-1,90 days oral NOAEL male/female rats = 30 mg/kg/day90 days oral LOAEL male/female rats = 100 mg/kg/day28 days oral NOAEL male/female rats = 17.8 mg/kg/day28 days oral LOAEL male/female rats = 56.2 mg/kg/day ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cee03ec1-2444-481a-b572-cd90fd631f40/documents/IUC5-92a6b414-fb10-4ba3-8394-d9d5fca0732d_2d0c50f3-cfab-4f4e-a046-c77dba04ee26.html,,,,,, "2,4,6-triallyloxy-1,3,5-triazine",101-37-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cee03ec1-2444-481a-b572-cd90fd631f40/documents/IUC5-92a6b414-fb10-4ba3-8394-d9d5fca0732d_2d0c50f3-cfab-4f4e-a046-c77dba04ee26.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "2,4,6-triallyloxy-1,3,5-triazine",101-37-1,"Acute oral LD50s in both, males and female rats, > 300 and < 2000 mg/kg bw. Acute dermal LD50 male/female >2000 mg/kg bwAcute respiratory LC50 in male rats > 0.333 mg/L ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cee03ec1-2444-481a-b572-cd90fd631f40/documents/IUC5-65c693ca-8d78-4b7b-bdeb-fd48d7ab5e20_2d0c50f3-cfab-4f4e-a046-c77dba04ee26.html,,,,,, "2,4,6-triallyloxy-1,3,5-triazine",101-37-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cee03ec1-2444-481a-b572-cd90fd631f40/documents/IUC5-65c693ca-8d78-4b7b-bdeb-fd48d7ab5e20_2d0c50f3-cfab-4f4e-a046-c77dba04ee26.html,,oral,LD50,753 mg/kg bw,adverse effect observed, "2,4,6-triallyloxy-1,3,5-triazine",101-37-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cee03ec1-2444-481a-b572-cd90fd631f40/documents/IUC5-65c693ca-8d78-4b7b-bdeb-fd48d7ab5e20_2d0c50f3-cfab-4f4e-a046-c77dba04ee26.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,4,6-tribromophenol",118-79-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fbae44a-9e99-41fe-ab5a-43e54c705f46/documents/d614379e-88d8-445f-bb76-484aee525f0a_470ac27a-c5e7-4850-9288-a4f9e5e5c05c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2,4,6-tribromophenol",118-79-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fbae44a-9e99-41fe-ab5a-43e54c705f46/documents/d614379e-88d8-445f-bb76-484aee525f0a_470ac27a-c5e7-4850-9288-a4f9e5e5c05c.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rabbit "2,4,6-tribromophenol",118-79-6,"Based on the data obtained, the LD50 of 2,4,6-tribromophenol was determined to be 1486 mg/kg with 95% confidence intervals of 1215 - 1792 mg/kg when administered once orally via gavage to male and female rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fbae44a-9e99-41fe-ab5a-43e54c705f46/documents/c0c68ca4-3eee-42f2-b23d-5e6d6ef89cfb_470ac27a-c5e7-4850-9288-a4f9e5e5c05c.html,,,,,, "2,4,6-tribromophenol",118-79-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fbae44a-9e99-41fe-ab5a-43e54c705f46/documents/c0c68ca4-3eee-42f2-b23d-5e6d6ef89cfb_470ac27a-c5e7-4850-9288-a4f9e5e5c05c.html,,oral,LD50,"1,486 mg/kg bw",adverse effect observed, "2,4,6-trichloro-1,3,5-triazine",108-77-0,"- Repeated dose toxicity, dermal: NOAEL(systemic) = 500 mg/kg bw/d, LOAEL(local) = 50 mg/kg bw /day for the rabbit, 21 d (OECD TG 410); study 83-0093-FKT- Repeated dose toxicity, inhalative: NOAEC(systemic) = 0.25 mg/m³, NOAEC(local) = 0.05 mg/m³ for the rat, 90 d (OECD TG 413); study 94-0211-FGT ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/414216b6-149a-48c8-93b7-276e1da6e371/documents/IUC5-7cb76224-012f-4e4c-ae68-2cac2493618d_562fa24e-27e1-4448-b96c-ac1a397ab68c.html,,,,,, "2,4,6-trichloro-1,3,5-triazine",108-77-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/414216b6-149a-48c8-93b7-276e1da6e371/documents/IUC5-7cb76224-012f-4e4c-ae68-2cac2493618d_562fa24e-27e1-4448-b96c-ac1a397ab68c.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rabbit "2,4,6-trichloro-1,3,5-triazine",108-77-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/414216b6-149a-48c8-93b7-276e1da6e371/documents/IUC5-7cb76224-012f-4e4c-ae68-2cac2493618d_562fa24e-27e1-4448-b96c-ac1a397ab68c.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.25 mg/m3,,rat "2,4,6-trichloro-1,3,5-triazine",108-77-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/414216b6-149a-48c8-93b7-276e1da6e371/documents/IUC5-7cb76224-012f-4e4c-ae68-2cac2493618d_562fa24e-27e1-4448-b96c-ac1a397ab68c.html,Repeated dose toxicity – local effects,dermal,LOAEL,50 ,adverse effect observed,rabbit "2,4,6-trichloro-1,3,5-triazine",108-77-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/414216b6-149a-48c8-93b7-276e1da6e371/documents/IUC5-7cb76224-012f-4e4c-ae68-2cac2493618d_562fa24e-27e1-4448-b96c-ac1a397ab68c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.05 mg/m3,adverse effect observed,rat "2,4,6-trichloro-1,3,5-triazine",108-77-0,"- Oral:LD50: 333.6 mg/kg bw (293.4 — 373.8 95% CL) for the rat (OECD TG 401); study 93-0170-FGT- Dermal: LD50: > 2000 mg/kg bw for the rabbit (limit test, OECD TG 402); study 88-0023-DKT- Inhalation:LC50: 170 (137 — 213; 95 % CL) mg/m³ for the male and female rat (OECD TG 403); study 92-0177-FKT ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/414216b6-149a-48c8-93b7-276e1da6e371/documents/IUC5-bf711a42-2d5b-4780-82a0-70fee6ae8984_562fa24e-27e1-4448-b96c-ac1a397ab68c.html,,,,,, "2,4,6-trichloro-1,3,5-triazine",108-77-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/414216b6-149a-48c8-93b7-276e1da6e371/documents/IUC5-bf711a42-2d5b-4780-82a0-70fee6ae8984_562fa24e-27e1-4448-b96c-ac1a397ab68c.html,,oral,LD50,333.6 mg/kg bw,adverse effect observed, "2,4,6-trichloro-1,3,5-triazine",108-77-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/414216b6-149a-48c8-93b7-276e1da6e371/documents/IUC5-bf711a42-2d5b-4780-82a0-70fee6ae8984_562fa24e-27e1-4448-b96c-ac1a397ab68c.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "2,4,6-trichloro-1,3,5-triazine",108-77-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/414216b6-149a-48c8-93b7-276e1da6e371/documents/IUC5-bf711a42-2d5b-4780-82a0-70fee6ae8984_562fa24e-27e1-4448-b96c-ac1a397ab68c.html,,inhalation,LC50,170 mg/m3,adverse effect observed, "2,4,6-trichloroaniline",634-93-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The quality of the database was very low, with only one document was available for which the original language was Russian. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16e19598-73fc-4ed4-950d-cae7c46f289c/documents/IUC5-f73fc4a6-49f7-4588-8ff0-15f45a347363_3ea42d3a-c549-487f-9ce9-0b3c49e38771.html,,,,,, "2,4,6-trichloroaniline",634-93-5,"Oral: LD50=1600 - 3200 mg/kg, rat, Jones 1970Oral: LD50=3850 ± 355 mg/kg, rat, gavage, Sapegin 1985Oral: LD50=2400 mg/kg, rat, RTECS, 1990Dermal: LD50 > 2000 mg/kg, rat, Zelenák, 2014 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16e19598-73fc-4ed4-950d-cae7c46f289c/documents/IUC5-d75fb3b4-a352-4135-bf9c-918e9ea78508_3ea42d3a-c549-487f-9ce9-0b3c49e38771.html,,,,,, "2,4,6-trichloroaniline",634-93-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16e19598-73fc-4ed4-950d-cae7c46f289c/documents/IUC5-d75fb3b4-a352-4135-bf9c-918e9ea78508_3ea42d3a-c549-487f-9ce9-0b3c49e38771.html,,oral,LD50,"1,600 mg/kg bw",adverse effect observed, "2,4,6-triisopropyl-m-phenylene diisocyanate",2162-73-4,"1) Non-GLP, 13 weeks, Fischer 344 rats, oral gavage, NOEAL males 30 mg/kg bw, females 60 mg/kg bw, questionable reliability 2) Non-GLP, 13 weeks, B6C3F1 mice, oral gavage, NOEAL males 240 mg/kg bw, females 60 mg/kg bw, questionable reliability 3) Non-GLP, 28 days, Spraque-Dawley rats, oral gavage, LOAEL 30 mg/kg kw, questionable reliability 4) carcinogenicity study, Sprague-Dawley rats, inhalation, whole- body, NOAEC 0.15 ppm 5) carcinogenicity study, CD1 mice, inhalation, whole-body, NOAEC 0.15 ppm 6) review on diisocyanates, OEL 0.005 ppm 7) carcinogen profile -Carex Canada, OEL 0.005 ppm for sensitisation and for short term exposure 0.02 ppm. 8) TRGS - MAK 0.005 ppm for Isocyanates 9) Inhalation, pMDI, 2 year, NOEAC 0.2 mg/m³ air, LOEAC 1 mg/ m³, Reutzel et al., 1994 10) Inhalation, MDI, 2 years, LOAEC 0.23 mg/m³, Hoymann, 1995 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df2e7c46-e3bd-4fd6-9b27-abb661416f65/documents/IUC5-c8512a2d-e3cb-42c6-ad45-a72c187e75a6_cf3d5406-ae41-41a9-a8a2-4ce8a921505c.html,,,,,, "2,4,6-triisopropyl-m-phenylene diisocyanate",2162-73-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df2e7c46-e3bd-4fd6-9b27-abb661416f65/documents/IUC5-c8512a2d-e3cb-42c6-ad45-a72c187e75a6_cf3d5406-ae41-41a9-a8a2-4ce8a921505c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "2,4,6-triisopropyl-m-phenylene diisocyanate",2162-73-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df2e7c46-e3bd-4fd6-9b27-abb661416f65/documents/IUC5-c8512a2d-e3cb-42c6-ad45-a72c187e75a6_cf3d5406-ae41-41a9-a8a2-4ce8a921505c.html,Chronic toxicity – systemic effects,inhalation,NOAEC,0.058 mg/m3,,rat "2,4,6-triisopropyl-m-phenylene diisocyanate",2162-73-4," 1. Acute oral toxicity (1990), GLP, OECD 401, rats, gavage, limit test with 2000 mg/kg, LD50 >2000 mg/kg bw 2. Acute inhalation toxicity (1990), GLP, OECD 403, rats, nose/head-only, 4 h, nominal concentrations: 0 (air control), 0 (acetone control, acetone: 212 mg/m³), 300, 306, 500, 700, 1000, 625 and 1250 mg/m³ air, LC50 = 110 mg/m³ air, NOAEC = 20 mg/m³ was taken for DNEL derivation. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df2e7c46-e3bd-4fd6-9b27-abb661416f65/documents/IUC5-a3ccb3f4-722b-4818-8cd1-2ab63644b12e_cf3d5406-ae41-41a9-a8a2-4ce8a921505c.html,,,,,, "2,4,6-triisopropyl-m-phenylene diisocyanate",2162-73-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df2e7c46-e3bd-4fd6-9b27-abb661416f65/documents/IUC5-a3ccb3f4-722b-4818-8cd1-2ab63644b12e_cf3d5406-ae41-41a9-a8a2-4ce8a921505c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,4,6-triisopropyl-m-phenylene diisocyanate",2162-73-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df2e7c46-e3bd-4fd6-9b27-abb661416f65/documents/IUC5-a3ccb3f4-722b-4818-8cd1-2ab63644b12e_cf3d5406-ae41-41a9-a8a2-4ce8a921505c.html,,inhalation,LC50,110 mg/m3,adverse effect observed, "2,4,6-trimethylbenzaldehyde",487-68-3,"Under the test conditions (OECD 407 and GLP), the NOEL of the test substance was estimated to be 40 mg/kg/day in rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7df8c70d-77da-4096-8e3c-6e04482a1880/documents/IUC5-21234076-c7d4-4f14-8bc6-b597f9162780_72a1b99c-0cac-4c0f-b6bc-4b24d137d48c.html,,,,,, "2,4,6-trimethylbenzaldehyde",487-68-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7df8c70d-77da-4096-8e3c-6e04482a1880/documents/IUC5-21234076-c7d4-4f14-8bc6-b597f9162780_72a1b99c-0cac-4c0f-b6bc-4b24d137d48c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat "2,4,6-trimethylbenzaldehyde",487-68-3,The acute oral LD50 of the test material in the Sprague-Dawley rat was >2000 mg/kg body weight (OECD 401). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7df8c70d-77da-4096-8e3c-6e04482a1880/documents/IUC5-97e5d40b-e9e5-4dcf-a180-c263a0685800_72a1b99c-0cac-4c0f-b6bc-4b24d137d48c.html,,,,,, "2,4,6-trimethylbenzene-1,3-diamine",3102-70-3,"In this experiment the test item was examined for acute toxicity after oral administration to rats. Dose levels of 300 or 2000 mg/kg b.w. were employed. The LD50value was ranked between 300 and 2000 mg/kg b.w., by oral administration (LPT, 2016).   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is valid without restriction (Klimisch 1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de26d9bf-2c5a-4e7c-8e72-bf9adc72f2b0/documents/c2cb6811-b1bf-4e2d-96dd-9708bd3b14d1_bfe16d6d-236f-40bc-9fb9-69de1f8d1b64.html,,,,,, "2,4,6-trimethylpyridine",108-75-8,"The LD50 in rats of the test item was found to be 400 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable publication ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1026363c-5e9a-47d4-9eda-0b21de576ef2/documents/34163b37-f05d-4a48-bfac-4e49a2c2c4ec_3e458f6a-2d88-4c89-982f-f8b3232b4800.html,,,,,, "2,4,6-trimethylpyridine",108-75-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1026363c-5e9a-47d4-9eda-0b21de576ef2/documents/34163b37-f05d-4a48-bfac-4e49a2c2c4ec_3e458f6a-2d88-4c89-982f-f8b3232b4800.html,,oral,LD50,400 mg/kg bw,adverse effect observed, "2,4,6-trinitrotoluene",118-96-7, Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint: The study with the longest duration and lowest NOAEL was chosen (key study). Repeated dose toxicity: via oral route - systemic effects (target organ)cardiovascular / hematological: blood coagulation; digestive: liver; urogenital: testes ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd280c0b-aef0-419c-884f-728b2d5b73e2/documents/IUC5-ae25fe1c-10ff-4b90-b9a9-2eb67550a9b3_fad91ae9-5489-4237-8cd4-6a46ce826abf.html,,,,,, "2,4,6-trinitrotoluene",118-96-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd280c0b-aef0-419c-884f-728b2d5b73e2/documents/IUC5-ae25fe1c-10ff-4b90-b9a9-2eb67550a9b3_fad91ae9-5489-4237-8cd4-6a46ce826abf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,1 mg/kg bw/day,,rat "2,4,6-trinitrotoluene",118-96-7," Justification for selection of acute toxicity – oral endpoint Only one study available. Justification for selection of acute toxicity – inhalation endpoint GLP study report available. Only one study available. Justification for selection of acute toxicity – dermal endpoint In accordance with column 2 of REACH Annex VIII, the testing by the dermal route is not appropriate if inhalation of the substance is likely. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd280c0b-aef0-419c-884f-728b2d5b73e2/documents/IUC5-de3daca8-8f81-44d0-8928-acc815666e64_fad91ae9-5489-4237-8cd4-6a46ce826abf.html,,,,,, "2,4,6-trinitrotoluene",118-96-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd280c0b-aef0-419c-884f-728b2d5b73e2/documents/IUC5-de3daca8-8f81-44d0-8928-acc815666e64_fad91ae9-5489-4237-8cd4-6a46ce826abf.html,,oral,LD50,795 mg/kg bw,adverse effect observed, "2,4,6-trinitrotoluene",118-96-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd280c0b-aef0-419c-884f-728b2d5b73e2/documents/IUC5-de3daca8-8f81-44d0-8928-acc815666e64_fad91ae9-5489-4237-8cd4-6a46ce826abf.html,,inhalation,LC50,1.01 mg/m3,no adverse effect observed, "2,4,6-tris(2,4,6-tribromophenoxy)-1,3,5-triazine",25713-60-4,28- Day Repeated-dose Oral toxicity study in rats with 14 days recovery period.91- Day Repeated-dose Oral toxicity study in rats with 28 day Recovery period ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89868f59-0423-4c7c-b932-1a66626fa84b/documents/IUC5-34a711b1-68b2-425b-8c31-1479d6915a78_49acfd2d-3d39-48da-afc6-a68263d83e46.html,,,,,, "2,4,6-tris(2,4,6-tribromophenoxy)-1,3,5-triazine",25713-60-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89868f59-0423-4c7c-b932-1a66626fa84b/documents/IUC5-34a711b1-68b2-425b-8c31-1479d6915a78_49acfd2d-3d39-48da-afc6-a68263d83e46.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,4,6-tris(2,4,6-tribromophenoxy)-1,3,5-triazine",25713-60-4,Acute Oral and Acute dermal toxicity studies.Acute inhalation study is waived based on low hazard and low risk ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89868f59-0423-4c7c-b932-1a66626fa84b/documents/IUC5-74ec5ff0-040a-41d0-932c-b65f8106a8d3_49acfd2d-3d39-48da-afc6-a68263d83e46.html,,,,,, "2,4,6-tris(2,4,6-tribromophenoxy)-1,3,5-triazine",25713-60-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89868f59-0423-4c7c-b932-1a66626fa84b/documents/IUC5-74ec5ff0-040a-41d0-932c-b65f8106a8d3_49acfd2d-3d39-48da-afc6-a68263d83e46.html,,oral,LD50,"2,000 mg/kg bw",, "2,4,6-tris(2,4,6-tribromophenoxy)-1,3,5-triazine",25713-60-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89868f59-0423-4c7c-b932-1a66626fa84b/documents/IUC5-74ec5ff0-040a-41d0-932c-b65f8106a8d3_49acfd2d-3d39-48da-afc6-a68263d83e46.html,,dermal,LD50,"2,000 mg/kg bw",, "2,4,6-tris(dimethylaminomethyl)phenol",90-72-2," A short term 14 day toxicity study was used as dose range finding study for the OECD 422 study. The dose levels were 0, 150, 250, 500 and 1000 mg/kg bw/d. The maximum tolerated dose was 150 mg/kg bw/d. Therefore, this dose was used as highest dose for the OECD 422 (SafePharm 2006). An OECD 422 study with Sprague-Dawley rats (SafePharm, 2006) is used as dose range finding study for the sub-chronic OECD 408 study (LPT, 2017). In this dose range finding study, the oral administration of test item to rats by gavage at a maximum dose level of 150 mg/kg/day resulted in toxicologically significant histopathological findings in the liver, spleen and brain. Similar brain histopathology was observed for a few animals at 50 mg/kg/day. The No Observed Effect Level (NOEL) for systemic toxicity was therefore considered to be 15 mg/kg/day (SafePharm, 2006). The 90 day oral exposure to 15, 50, and 150 mg test item/kg bw (male and female Sprague-Dawley rats; OECD 408; LPT, 2017) led to adverse test item-related effects at 50 mg test item/kg b.w./day in form of a decreased drinking water consumption and of histopathological changes, at 150 mg test item/kg b.w./day in form of a reduced body weight, a decreased food and drinking water consumption, changes in biochemical parameters, organ weights and at histopathological examination compared to the control group. By morphology and distribution, the findings are indicative for phospholipidosis, which were confirmed in additional examinations. Selected animals from the control, intermediate and high dose groups were re-evaluated (Weber, 2018): The previously reported findings were confirmed. The alterations were not associated with further inflammatory and/or degenerative lesions, and showed partial or complete recovery. In addition, there were reduced reproductive organ weights (epididymides, prostate glands, seminal vesicles, and ovaries and uterus) without related with specific changes in oocytes or sperm cells but with vacuolation of arteries and smooth muscle cells. Therefore, a primary effect on reproductive organs cannot be considered. The same is true for the effects endocrine organs, i.e., the pituitary gland and adrenal glands. The findings are consistent with phospholipidosis. A primary affection of the endocrine system cannot be concluded. In conclusion, the test item caused no findings at 15 mg/kg b.w. /day. Furthermore, at higher doses, there was a lack of concurrent adverse toxicity or dysfunction in the affected organs. The electron microscopy evaluation revealed the presence of membrane bound vacuoles indicative for lysosome containing myelin figures. They were noted in the brain plexus epithelia, in smooth muscle fibers of the heart, in liver macrophages, in renal tubular cells and in the smooth muscle fibers of lungs. The finding of lysosomes containing myelin figures is proving the hypothesis of phospholipidosis (Chatman et al., 2009; Nolte et al., 2016), which is regarded to be not relevant for human health. Under the present test conditions of this study, the NOAEL (No-Observed-Adverse-Effect-Level) is 15 mg test item/kg b.w./day by oral administration for 90 days. Furthermore, at higher doses, there was a lack of concurrent adverse toxicity or dysfunction in the affected organs. No valid repeated-dose toxicity studies are available for the dermal and inhalation routes of exposure. Data waiver are claimed. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79c73617-8590-40b2-a479-f515b36fd242/documents/IUC5-2f56e31d-33da-4272-814e-12609a577e13_0f9c6897-49d0-4064-8880-70d922eb588e.html,,,,,, "2,4,6-tris(dimethylaminomethyl)phenol",90-72-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79c73617-8590-40b2-a479-f515b36fd242/documents/IUC5-2f56e31d-33da-4272-814e-12609a577e13_0f9c6897-49d0-4064-8880-70d922eb588e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "2,4,6-tris(dimethylaminomethyl)phenol",90-72-2," The oral toxicity of the test item is > 2000 mg/kg/bw since 3 out of 10 animals died at this dose level (SafePharm, 1992). As the test item is considered to be corrosive to skin (Skin Corr. 1C) a dermal LD50 study according to a current guideline has not been performed. As part of a 14-day repeated dermal study rats were exposed to the test item at 1000 mg/kg/bw 6 hours per day for 4 days. No animal died but this dosage level was terminated for humane reasons due to the severity of the skin effects. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79c73617-8590-40b2-a479-f515b36fd242/documents/IUC5-55eb37d3-c94f-43d4-8a1c-d1652a5b8b3f_0f9c6897-49d0-4064-8880-70d922eb588e.html,,,,,, "2,4,6-tris(dimethylaminomethyl)phenol",90-72-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79c73617-8590-40b2-a479-f515b36fd242/documents/IUC5-55eb37d3-c94f-43d4-8a1c-d1652a5b8b3f_0f9c6897-49d0-4064-8880-70d922eb588e.html,,oral,LD50,"2,169 mg/kg bw",no adverse effect observed, "2,4,7,9-Tetramethyldec-5-yne-4,7-diol, ethoxylated",9014-85-1,"Under the conditions of a 28 d oral toxicity study according to OECD guideline 422, higher mean liver weights in combination with changes in clinical chemistry parameters and hepatocellular hypertrophy were noted at 7500 ppm in both sexes. Therefore, a dietary concentration of 2500 ppm was considered to be the no-observed-adverse-effect concentration (NOAEL) for F0 systemic toxicity of the test item when administered continuously in the diet to Crl:CD(SD) rats. This concentration corresponded to mean dose levels of 184 and 200 mg/kg/day for F0 males and females during the premating period, Gestation, Lactation Days 1–4, and Lactation Days 4–13, respectively. Additionally, 2,4,7,9-Tetramethyl-5-decyne-4,7-diol, a structural analogue, when fed to rats under the conditions of an one generation reproductive toxicity study, showed no effect at 500 mg/kg/day (NOEL).At 2,000 mg/kg/day slightly decreased mean body weigths of females after weaning, lacation indices in combination with slghtliy reduced food consumption were observed. At dose levels at greater than or equal to 1,000 mg/kg/day slightly decreased body weight gain, increased liver weight and swelling of hepatocytes were observed in the F1a generation (epxosure duration: 91 days).There were no other significant changes in any parameter reported. Furthermore, a NOEL of 1000 mg/kg/d was derived from the repeated dose toxicity part (90 d dosing period via diet) in rats performed with 2,4,7,9-Tetramethyl-5-decyne-4,7-diol, ethoxylated, an additional structural analogue. The only pertinent effects observed were a significant decrease of body weight and an increase of liver weight.     Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable without restriction ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c99ef033-6326-4ac8-86f4-df672881a7ce/documents/38be8854-53c8-4e97-9579-901f6680b34f_370886de-98d8-4a70-995e-c10549bd386f.html,,,,,, "2,4,7,9-Tetramethyldec-5-yne-4,7-diol, ethoxylated",9014-85-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c99ef033-6326-4ac8-86f4-df672881a7ce/documents/38be8854-53c8-4e97-9579-901f6680b34f_370886de-98d8-4a70-995e-c10549bd386f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,184 mg/kg bw/day,,rat "2,4,7,9-Tetramethyldec-5-yne-4,7-diol, ethoxylated",9014-85-1," oral LD50 > 2000 mg/kg bw (read-across from 2,4,7,9-Tetramethyl-5-decyne-4,7-diol and 2,4,7,9-Tetramethyl-5-decyne-4,7-diol, ethoxylated (3.8)) inhalation LC50(1 h) > 20 mg/m³ (read-across from 2,4,7,9-Tetramethyl-5-decyne-4,7-diol) dermal LD50 > 2000 mg/kg bw (read-across from 2,4,7,9-Tetramethyl-5-decyne-4,7-diol) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c99ef033-6326-4ac8-86f4-df672881a7ce/documents/1018ecfa-93b9-49a7-884c-90c717204ecc_370886de-98d8-4a70-995e-c10549bd386f.html,,,,,, "2,4,7,9-Tetramethyldec-5-yne-4,7-diol, ethoxylated",9014-85-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c99ef033-6326-4ac8-86f4-df672881a7ce/documents/1018ecfa-93b9-49a7-884c-90c717204ecc_370886de-98d8-4a70-995e-c10549bd386f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,4,7,9-Tetramethyldec-5-yne-4,7-diol, ethoxylated",9014-85-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c99ef033-6326-4ac8-86f4-df672881a7ce/documents/1018ecfa-93b9-49a7-884c-90c717204ecc_370886de-98d8-4a70-995e-c10549bd386f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,4,7,9-Tetramethyldec-5-yne-4,7-diol, ethoxylated",9014-85-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c99ef033-6326-4ac8-86f4-df672881a7ce/documents/1018ecfa-93b9-49a7-884c-90c717204ecc_370886de-98d8-4a70-995e-c10549bd386f.html,,inhalation,LC50,20 mg/m3,no adverse effect observed, "2,4,7-trimethyloct-6-en-1-ol",1913285-57-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/912a881a-2f28-4f76-944f-c99539964c35/documents/7903913b-bb6b-47a3-bc83-f07d824b518e_b0947ebf-a161-422b-a7ae-2acfcbab2e27.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,4,8,10-tetra(tert-butyl)-6-hydoroxy-12H-dibenzo[d,g] [1,3,2]dioxaphosphocin, 6-oxide",106396-29-6," 28d repeated oral: Adverse effects on the intestines, mesenteric lymph node and blood coagulation were observed by repeated doses of the test item. The NOAEL (No observable adverse effect level) under the conditions of this study was considered to be 170 mg/kg/day and no adverse effects were detected in the 170 mg/kg groups. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13c48935-5ef0-4a2c-b932-440f9af1c2e5/documents/b121ebbf-1381-403a-97e2-bbc399ddd858_04a11269-d00c-4dfe-9271-1c5cbeefd30e.html,,,,,, "2,4,8,10-tetra(tert-butyl)-6-hydoroxy-12H-dibenzo[d,g] [1,3,2]dioxaphosphocin, 6-oxide",106396-29-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13c48935-5ef0-4a2c-b932-440f9af1c2e5/documents/b121ebbf-1381-403a-97e2-bbc399ddd858_04a11269-d00c-4dfe-9271-1c5cbeefd30e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,170 mg/kg bw/day,,rat "2,4,8,10-tetra(tert-butyl)-6-hydoroxy-12H-dibenzo[d,g] [1,3,2]dioxaphosphocin, 6-oxide",106396-29-6, Acute oral toxicity: LD50 > 2000 mg/kg bodyweight (OECD Guideline 423) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13c48935-5ef0-4a2c-b932-440f9af1c2e5/documents/e17d9375-5bf4-424e-be4f-d73cb31238c7_04a11269-d00c-4dfe-9271-1c5cbeefd30e.html,,,,,, "2,4,8,10-tetra(tert-butyl)-6-hydoroxy-12H-dibenzo[d,g] [1,3,2]dioxaphosphocin, 6-oxide",106396-29-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13c48935-5ef0-4a2c-b932-440f9af1c2e5/documents/e17d9375-5bf4-424e-be4f-d73cb31238c7_04a11269-d00c-4dfe-9271-1c5cbeefd30e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxide, sodium salt",85209-91-2," Subacute combined repeated dose and reproduction / developmental screening study (OECD 421): NOAEL for parental animals = 100 mg/kg/day. Subchronic  toxicity study: 13-weeks oral (Gavage) toxicity study (from 1986) with  NA-11 in rats, similar to OECD Guideline 408 EU Method B.26: NOEL = 500 mg/kg/day for both sexes based on food intake suppression. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3da7b7cf-4554-4c33-873b-0f76f63138da/documents/IUC5-179b8e30-7daa-4e74-ae00-67f502f0a948_4e550216-07da-40ef-afb9-a1e737701484.html,,,,,, "2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxide, sodium salt",85209-91-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3da7b7cf-4554-4c33-873b-0f76f63138da/documents/IUC5-179b8e30-7daa-4e74-ae00-67f502f0a948_4e550216-07da-40ef-afb9-a1e737701484.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxide, sodium salt",85209-91-2," Acute Toxicity: Oral: LD50> 2000 mg/kg b.w. for rat (OECD 423) Dermal: LD50> 2000 mg/kg b.w. for rat (OECD 402, 24h exposure) Inhalation:  LC50= 3110 mg/m³ for rat, with the analogous read-across substance NA-70 (OECD 403, 4 h exposure) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3da7b7cf-4554-4c33-873b-0f76f63138da/documents/IUC5-4eae13de-1de0-4ba9-9e8c-8206d535d3a1_4e550216-07da-40ef-afb9-a1e737701484.html,,,,,, "2,4,8,10-tetra(tert-butyl)-6-hydroxy-12H-dibenzo[d,g][1,3,2]dioxaphosphocin 6-oxide, sodium salt",85209-91-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3da7b7cf-4554-4c33-873b-0f76f63138da/documents/IUC5-4eae13de-1de0-4ba9-9e8c-8206d535d3a1_4e550216-07da-40ef-afb9-a1e737701484.html,,inhalation,LC50,"3,110 mg/m3",adverse effect observed, "2,4,8,10-tetraoxa-3λ6,9λ6-dithiaspiro[5.5]undecane 3,3,9,9-tetraoxide",201419-80-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 1 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da592581-188c-4568-a95e-00297b0f15a7/documents/e1a32a5f-04a4-4061-b04c-f6107118d66b_667083a5-f9f7-4cd0-9249-dd904e5aa3e0.html,,,,,, "2,4,8,10-tetraoxa-3λ6,9λ6-dithiaspiro[5.5]undecane 3,3,9,9-tetraoxide",201419-80-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da592581-188c-4568-a95e-00297b0f15a7/documents/e1a32a5f-04a4-4061-b04c-f6107118d66b_667083a5-f9f7-4cd0-9249-dd904e5aa3e0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,1.3 mg/kg bw/day,,rat "2,4,8,10-tetraoxa-3λ6,9λ6-dithiaspiro[5.5]undecane 3,3,9,9-tetraoxide",201419-80-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Acute inhalation LC50 in rat equal to 1.36e+03 mg/m3/h (1.36 mg/L/h) Classified as CLP aucute toxicity inhalation category 4. H332 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): 1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da592581-188c-4568-a95e-00297b0f15a7/documents/b60894ed-06d6-4e21-9b00-0105519c6785_667083a5-f9f7-4cd0-9249-dd904e5aa3e0.html,,,,,, "2,4,8,10-tetraoxa-3λ6,9λ6-dithiaspiro[5.5]undecane 3,3,9,9-tetraoxide",201419-80-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da592581-188c-4568-a95e-00297b0f15a7/documents/b60894ed-06d6-4e21-9b00-0105519c6785_667083a5-f9f7-4cd0-9249-dd904e5aa3e0.html,,oral,LD50,25 mg/kg bw,adverse effect observed, "2,4,8,10-tetraoxa-3λ6,9λ6-dithiaspiro[5.5]undecane 3,3,9,9-tetraoxide",201419-80-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da592581-188c-4568-a95e-00297b0f15a7/documents/b60894ed-06d6-4e21-9b00-0105519c6785_667083a5-f9f7-4cd0-9249-dd904e5aa3e0.html,,dermal,LD50,"ca.1,000 mg/kg bw",adverse effect observed, "2,4,8,10-tetraoxa-3λ6,9λ6-dithiaspiro[5.5]undecane 3,3,9,9-tetraoxide",201419-80-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da592581-188c-4568-a95e-00297b0f15a7/documents/b60894ed-06d6-4e21-9b00-0105519c6785_667083a5-f9f7-4cd0-9249-dd904e5aa3e0.html,,inhalation,LC50,"1,360 mg/m3",adverse effect observed, "3,9-bis(1,1-dimethyl-2-hydroxy ethyl)-2,4,8,10-tetraoxaspiro[5,5]undecane",1455-42-1,"Oral administration of the test material to rats for a period of twenty-eight consecutive days according to OECD Guideline 407 at dose levels of 15, 150 and 1000 mg/kg/day produced no toxicologically significant changes in the parameters measured. The “No Observed Effect Level” (NOEL) was therefore considered to be 1000 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20354318-c6bf-4d4a-83bb-306b8b095bef/documents/IUC5-a83bc0fa-d48b-45af-9651-092f0214ef59_492e53c0-02c8-4a7b-9124-57e1e027f1ff.html,,,,,, "3,9-bis(1,1-dimethyl-2-hydroxy ethyl)-2,4,8,10-tetraoxaspiro[5,5]undecane",1455-42-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20354318-c6bf-4d4a-83bb-306b8b095bef/documents/IUC5-a83bc0fa-d48b-45af-9651-092f0214ef59_492e53c0-02c8-4a7b-9124-57e1e027f1ff.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,9-bis(1,1-dimethyl-2-hydroxy ethyl)-2,4,8,10-tetraoxaspiro[5,5]undecane",1455-42-1,The test substance was assessed for acute oral toxicity performed according to EU Method B1 and OECD Guideline 423; and acute inhalation toxicity performed according to EU Method B2 and OECD Guideline 403. The acute oral median lethal dose (LD50) in the rat was greater than 2500 mg/kg bw.The acute inhalation median lethal concentration (4 hr LC50) in the rat was greater than 4.98 mg/L. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20354318-c6bf-4d4a-83bb-306b8b095bef/documents/IUC5-06687b5d-e439-445d-a31d-453967a5d5ac_492e53c0-02c8-4a7b-9124-57e1e027f1ff.html,,,,,, "3,9-bis(1,1-dimethyl-2-hydroxy ethyl)-2,4,8,10-tetraoxaspiro[5,5]undecane",1455-42-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20354318-c6bf-4d4a-83bb-306b8b095bef/documents/IUC5-06687b5d-e439-445d-a31d-453967a5d5ac_492e53c0-02c8-4a7b-9124-57e1e027f1ff.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "3,9-bis(1,1-dimethyl-2-hydroxy ethyl)-2,4,8,10-tetraoxaspiro[5,5]undecane",1455-42-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20354318-c6bf-4d4a-83bb-306b8b095bef/documents/IUC5-06687b5d-e439-445d-a31d-453967a5d5ac_492e53c0-02c8-4a7b-9124-57e1e027f1ff.html,,inhalation,LC50,4.98 mg/m3,no adverse effect observed, "2,4-bis[(4-dodecylphenyl)azo]resorcinol",65087-00-5," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is >5000 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 2.19E-19 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21b2ffd4-b5ce-4764-b533-4f8fb18cb1bd/documents/53caad1f-7675-4c92-a72c-86972f3c0d5c_e8713172-5b5a-4f6b-9b9e-b85e9ea15acb.html,,,,,, "2,4-bis[(4-dodecylphenyl)azo]resorcinol",65087-00-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21b2ffd4-b5ce-4764-b533-4f8fb18cb1bd/documents/53caad1f-7675-4c92-a72c-86972f3c0d5c_e8713172-5b5a-4f6b-9b9e-b85e9ea15acb.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,4-bis[(4-dodecylphenyl)azo]resorcinol",65087-00-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21b2ffd4-b5ce-4764-b533-4f8fb18cb1bd/documents/53caad1f-7675-4c92-a72c-86972f3c0d5c_e8713172-5b5a-4f6b-9b9e-b85e9ea15acb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,4-diethyl-9H-thioxanthen-9-one",82799-44-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e7d2d47-62b1-46f8-befd-48ec155078dc/documents/a7cd863b-840a-402c-85a4-73421bb5e012_b4a8ae38-242e-437d-a092-65003d77614f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,4-diethyl-9H-thioxanthen-9-one",82799-44-8,"The acute oral toxicity of the test substance is currently evaluated using data from the read across substance 2-isopropylthioxanthone (ITX, CAS 5495-84-1, EC 226-827-9). Based on this information, the test substance is not considered to be acutely toxic via the oral route of exposure. Acute oral toxicity testing on the substance itself is planned and will be submitted at the next dossier update.  ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e7d2d47-62b1-46f8-befd-48ec155078dc/documents/2102884b-f5c9-4cfc-9027-156c3eef8d7c_b4a8ae38-242e-437d-a092-65003d77614f.html,,,,,, "2,4-diethyl-9H-thioxanthen-9-one",82799-44-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e7d2d47-62b1-46f8-befd-48ec155078dc/documents/2102884b-f5c9-4cfc-9027-156c3eef8d7c_b4a8ae38-242e-437d-a092-65003d77614f.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,4-dihydro-2,5-dimethyl-3H-pyrazol-3-one",2749-59-9, The acute oral LD50 was determined to be > 300 - < 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32ce5056-428d-40dd-82ea-8759ea696c86/documents/7b107602-e626-494b-8ad5-5fad0dacd42d_533ef08e-ad67-4805-8333-0a3e43116bf5.html,,,,,, "2,4-dihydro-2,5-dimethyl-3H-pyrazol-3-one",2749-59-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32ce5056-428d-40dd-82ea-8759ea696c86/documents/7b107602-e626-494b-8ad5-5fad0dacd42d_533ef08e-ad67-4805-8333-0a3e43116bf5.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "2,4-dimethyl-6-(1-methyl-pentadecyl)phenol",134701-20-5,"Repeat-dose oral toxicity studies in rats were performed with treatment durations of 28 and 90 days. A NOAEL was established at 50 mg/kg/day in the subchronic study. Liver and thyroid glands were identified as the main target organs, although the findings obviously reflect adaptive liver changes of the rat to exogenous substances, secondarily affecting the thyroid gland. The increased kidney weights were considered as treatment-related although a histopathological correlate was observed only in the dose-range finding study at excessive dosages. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5460ce70-c94f-4dfd-bb92-05f063b24145/documents/IUC5-ec4a9024-c4a3-4dab-9e86-8e8d2c519b15_838abbe6-cb52-4003-8b6e-7aed13429867.html,,,,,, "2,4-dimethyl-6-(1-methyl-pentadecyl)phenol",134701-20-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5460ce70-c94f-4dfd-bb92-05f063b24145/documents/IUC5-ec4a9024-c4a3-4dab-9e86-8e8d2c519b15_838abbe6-cb52-4003-8b6e-7aed13429867.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "2,4-dimethyl-6-(1-methyl-pentadecyl)phenol",134701-20-5,"Acute oral toxicity: LD50 > 2000 mg/kg bw; Ciba-Geigy 1991, OECD Guideline StudyAcute dermal toxicity: LD50 > 2000 mg/kg bw; Ciba-Geigy 1991, OECD Guideline Study ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5460ce70-c94f-4dfd-bb92-05f063b24145/documents/IUC5-3dd4a6b0-b2e0-4998-9d6a-94b24710f665_838abbe6-cb52-4003-8b6e-7aed13429867.html,,,,,, "2,4-dimethyl-6-(1-methyl-pentadecyl)phenol",134701-20-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5460ce70-c94f-4dfd-bb92-05f063b24145/documents/IUC5-3dd4a6b0-b2e0-4998-9d6a-94b24710f665_838abbe6-cb52-4003-8b6e-7aed13429867.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,4-dimethyl-6-(1-methyl-pentadecyl)phenol",134701-20-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5460ce70-c94f-4dfd-bb92-05f063b24145/documents/IUC5-3dd4a6b0-b2e0-4998-9d6a-94b24710f665_838abbe6-cb52-4003-8b6e-7aed13429867.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2',4'-dimethylacetoacetanilide",97-36-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8afd9ccb-209e-4fe9-a95a-8ece08e5de86/documents/IUC5-dda1fb1c-5577-4a84-a60c-ab4944b90195_b065bb16-29ba-4d25-9fdb-376def63e5fc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat "2',4'-dimethylacetoacetanilide",97-36-9,"- oral:KEY_401_1980_BASF_1980-05-23:LD50, rat, male/female: 1995 mg/kg bw, reliability 2NON KEY_401_1979_Hazleton_ 1842-733/18: LD50, rat, male: 3000 mg/kg bw, reliability 2LD50, rat, female: 3217 mg/kg bw, reliability 2LD50, rat, male/female: 3094 mg/kg bw, reliability 2NON KEY_401_1973_Consultox_CL73:91:889: LD50, mouse, male/female: 1400 mg/kg bw, reliability 2LD50 range finding, mouse, male: >1000, <2500 mg/kg bw, reliability 3LD50 range finding, rat, female: >1000, <2500 mg/kg bw, reliability 3LD50 range finding, rabbit: >1000, <2500 mg/kg bw, reliability 3NON KEY_1992 (1975)_Eastman Kodak_278330S: LD50, rat: 800 mg/kg bw, reliability 3LD50, mouse: 1131 mg/kg bw, reliability 3NONKEY_MetHb_1980_BASF_1980-05-23:LD50, cat, male/female: approximately 200 mg/kg bw, lethality not caused by MetHb formation, reliability 2- inhalation:NONKEY_403_1980_ BASF_1980-05-23:no inhalation risk, reliability 3- intraperitoneal:LD50, mouse, male/female: >700, < 2000 mg/kg bw, not adequate, not relevant for classification ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8afd9ccb-209e-4fe9-a95a-8ece08e5de86/documents/IUC5-39d47457-58b4-4221-a72b-4449e30c792a_b065bb16-29ba-4d25-9fdb-376def63e5fc.html,,,,,, "2',4'-dimethylacetoacetanilide",97-36-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8afd9ccb-209e-4fe9-a95a-8ece08e5de86/documents/IUC5-39d47457-58b4-4221-a72b-4449e30c792a_b065bb16-29ba-4d25-9fdb-376def63e5fc.html,,oral,LD50,"1,995 mg/kg bw",, "2,4-dinitroanisole",119-27-7, Oral toxicity - NOAEL in rats was found to be 1.25 mg/kg bw/day Inhalation toxicity - NOAEC in rats was found to be 165 mg/m3. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d7f1760-6328-4d83-9c74-0863092bc679/documents/3a2b2f67-e03c-4ae2-9df5-8c8f02ea1d33_d9ce3c50-eceb-456f-bb31-ef3f939b1ca8.html,,,,,, "2,4-dinitroanisole",119-27-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d7f1760-6328-4d83-9c74-0863092bc679/documents/3a2b2f67-e03c-4ae2-9df5-8c8f02ea1d33_d9ce3c50-eceb-456f-bb31-ef3f939b1ca8.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,165 mg/m3,,rat "2,4-dinitroanisole",119-27-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d7f1760-6328-4d83-9c74-0863092bc679/documents/3a2b2f67-e03c-4ae2-9df5-8c8f02ea1d33_d9ce3c50-eceb-456f-bb31-ef3f939b1ca8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,1.25 mg/kg bw/day,,rat "2,4-dinitroanisole",119-27-7," Envigo Research Limited, 2017: An acute oral toxicity in the Wistar strain rat has been performed, according the 420 OECD guideline in order to assess the LD50 of the test item. Following a sighting test at dose levels of 50, 300 and 2000 mg/kg, a further group of four fasted females was given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 300 mg/kg. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. At 2000 mg/kg, one animal was killed because of evident sign of systemic toxicity, which was confirmed by necropsy. At 50 and 300 mg/kg dose levels, no mortality, no sign of systemic toxicity (also in necropsy) were observed. Therefore, the LD50 ot the test item in the female Wistar strain rat is estimated to be in the range of 300 -2000 mg/kg.   Lent et al 2012: Mortality occurred in all male rats at doses of 300.0 mg/kg and greater, occurring 3 ± 1.7 hours after administration of the test substance. Mortality occurred in female rats dosed at 300.0 mg/kg and greater with the exception of the rat dosed at 450.0 mg/kg which survived the 14-day observation period. Mortality occurred in female rats 4 ± 1.7 hours after administration of the test substance. Clinical signs including lethargy, rapid respiration/laboured breathing, prostrate posture, and salivation were noted in male rats at dose level of 88.9 mg/kg and greater and in female rats at dose level of 133.3 mg/kg and greater. Female rats additionally exhibited chromodacryorrhea. Clinical signs were apparent approximately fifteen to thirty minutes after dosing and persisted throughout the first day of observation in surviving animals.   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d7f1760-6328-4d83-9c74-0863092bc679/documents/6f814235-7359-4c1d-9029-1cb13a27eeca_d9ce3c50-eceb-456f-bb31-ef3f939b1ca8.html,,,,,, "2,4-dinitroanisole",119-27-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d7f1760-6328-4d83-9c74-0863092bc679/documents/6f814235-7359-4c1d-9029-1cb13a27eeca_d9ce3c50-eceb-456f-bb31-ef3f939b1ca8.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "2,4-dioxo-1,3-diazetidine-1,3-bis(methyl-m-phenylene) diisocyanate",26747-90-0,"Metalink U shows no systemic toxicity in a subacute (4 -week) inhalation study in rats up to the highest test concentration (solid aerosol) of 11.1 mg/m3 (Kopf, 2016). Evidence of portal-of-entry toxicity in the lungs were seen at 3.1 and 11.1 mg/m3. The NOAEC is considered to be 1.2 mg/m3 . Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): The study is GLP compliant and is of high quality (Klimisch score=1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The study is GLP compliant and is of high quality (Klimisch score=1) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/508e54f9-98cb-4d61-a168-5e8547d16102/documents/8c3e474f-72e9-41e6-ada2-0a9c268b9984_5274e629-4a98-49f5-80d3-fe3ec0f2e7df.html,,,,,, "2,4-dioxo-1,3-diazetidine-1,3-bis(methyl-m-phenylene) diisocyanate",26747-90-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/508e54f9-98cb-4d61-a168-5e8547d16102/documents/8c3e474f-72e9-41e6-ada2-0a9c268b9984_5274e629-4a98-49f5-80d3-fe3ec0f2e7df.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1.2 mg/m3,adverse effect observed,rat "2,4-dioxo-1,3-diazetidine-1,3-bis(methyl-m-phenylene) diisocyanate",26747-90-0,"The acute toxicity of Metalink U in rats is > 2500 mg/kg bw (LD50) after oral administration (Kimmerle, 1961) or > 1120 mg/m3 (LC50) after inhalation exposure (Kopf, 2015a). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is of sufficient quality (Klimisch score=2) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The study is GLP compliant and is of high quality (Klimisch score=1) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/508e54f9-98cb-4d61-a168-5e8547d16102/documents/0a66e749-afb3-4ebd-9aa7-a4e5e22b49ec_5274e629-4a98-49f5-80d3-fe3ec0f2e7df.html,,,,,, "2,4-dioxo-1,3-diazetidine-1,3-bis(methyl-m-phenylene) diisocyanate",26747-90-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/508e54f9-98cb-4d61-a168-5e8547d16102/documents/0a66e749-afb3-4ebd-9aa7-a4e5e22b49ec_5274e629-4a98-49f5-80d3-fe3ec0f2e7df.html,,oral,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "2,4-dioxo-1,3-diazetidine-1,3-bis(methyl-m-phenylene) diisocyanate",26747-90-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/508e54f9-98cb-4d61-a168-5e8547d16102/documents/0a66e749-afb3-4ebd-9aa7-a4e5e22b49ec_5274e629-4a98-49f5-80d3-fe3ec0f2e7df.html,,inhalation,discriminating conc.,"1,120 mg/m3",no adverse effect observed, "2,4-di-tert-butylphenol",96-76-4,Repeated dose toxicity oral: NOAEL = 150 mg/kg/day (Combined 1-generation reproduction toxicity/13 week repeat dose toxicity study) ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e675d13-cff4-4a9a-8387-b0c9dafcbf45/documents/73606d93-9d34-4083-a53c-018f947ec216_1b06d41b-9703-4f19-859c-b4a07b636c27.html,,,,,, "2,4-di-tert-butylphenol",96-76-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e675d13-cff4-4a9a-8387-b0c9dafcbf45/documents/73606d93-9d34-4083-a53c-018f947ec216_1b06d41b-9703-4f19-859c-b4a07b636c27.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "2,4-di-tert-butylphenol",96-76-4,"Acute toxicity oral: LD50 > 2000 mg/kg body weightAcute toxicity dermal: LD50 > 5000 mg/kg bodyweight (non-guideline, read-across) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e675d13-cff4-4a9a-8387-b0c9dafcbf45/documents/a0d4cfee-e233-4962-8f60-7a66e2efec54_1b06d41b-9703-4f19-859c-b4a07b636c27.html,,,,,, "2,4-di-tert-butylphenol",96-76-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e675d13-cff4-4a9a-8387-b0c9dafcbf45/documents/a0d4cfee-e233-4962-8f60-7a66e2efec54_1b06d41b-9703-4f19-859c-b4a07b636c27.html,,oral,LD50,"2,000 mg/kg bw",, "2,4-di-tert-butylphenol",96-76-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e675d13-cff4-4a9a-8387-b0c9dafcbf45/documents/a0d4cfee-e233-4962-8f60-7a66e2efec54_1b06d41b-9703-4f19-859c-b4a07b636c27.html,,dermal,LD50,"5,000 mg/kg bw",, "2,4-di-tert-butylphenyl 3,5-di-tert-butyl-4-hydroxybenzoate",4221-80-1, In two subchronic feeding studies with rats and beagle dogs the test item showed no adverse effects. The NOAEL was 691 mg/kg bw/d (male) and 704 mg/kg bw/d (female) during the 90 day study with beagle dogs. In the subchronic study with rats the NOAEL was determined to be 1687 mg/kg bw/d (male/female). ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/facf3df5-ea06-49b8-b373-26d7539bdcea/documents/10aa8157-1a71-46c6-890a-4c769a20f251_235d1836-16c3-4079-a022-ad4464da24a0.html,,,,,, "2,4-di-tert-butylphenyl 3,5-di-tert-butyl-4-hydroxybenzoate",4221-80-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/facf3df5-ea06-49b8-b373-26d7539bdcea/documents/10aa8157-1a71-46c6-890a-4c769a20f251_235d1836-16c3-4079-a022-ad4464da24a0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,691 mg/kg bw/day,,dog "2,4-di-tert-butylphenyl 3,5-di-tert-butyl-4-hydroxybenzoate",4221-80-1," The oral LD50 in rats was determined to be greater than 10000 mg/kg body weight. No deaths occurred at any dosage levels used. The LC50 by inhalation in male and female rats exposed to the substance for four hours is greater than 500 mg/m³, air. The dermal LD50 in rats was determined to be greater than 10000 mg/kg body weight. No deaths were caused by the test substance and no outward symptoms of toxicity were observed.   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/facf3df5-ea06-49b8-b373-26d7539bdcea/documents/fec712cb-599f-4362-851b-7c38cb133ca8_235d1836-16c3-4079-a022-ad4464da24a0.html,,,,,, "2,4-di-tert-butylphenyl 3,5-di-tert-butyl-4-hydroxybenzoate",4221-80-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/facf3df5-ea06-49b8-b373-26d7539bdcea/documents/fec712cb-599f-4362-851b-7c38cb133ca8_235d1836-16c3-4079-a022-ad4464da24a0.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "2,4-di-tert-butylphenyl 3,5-di-tert-butyl-4-hydroxybenzoate",4221-80-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/facf3df5-ea06-49b8-b373-26d7539bdcea/documents/fec712cb-599f-4362-851b-7c38cb133ca8_235d1836-16c3-4079-a022-ad4464da24a0.html,,dermal,LD50,"10,000 mg/kg bw",no adverse effect observed, "2,4-di-tert-butylphenyl 3,5-di-tert-butyl-4-hydroxybenzoate",4221-80-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/facf3df5-ea06-49b8-b373-26d7539bdcea/documents/fec712cb-599f-4362-851b-7c38cb133ca8_235d1836-16c3-4079-a022-ad4464da24a0.html,,inhalation,LC50,500 mg/m3,no adverse effect observed, "2,4-dithiapentane",1618-26-4," Oral: In an acute oral toxicicty study conducted according to OECD Guideline 423 in rats, an oral LD50 > 2000 mg/kg bw was determined (UN GHS: no classification) (reference 7.2.1-1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c16b366-61f6-4ec9-acaf-07a9c7d62018/documents/ec6d89ae-6e1c-4d15-9ee5-6e6536d8da8a_00f356a0-401e-4b6b-8307-f9f183471ecd.html,,,,,, "2,4-dithiapentane",1618-26-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c16b366-61f6-4ec9-acaf-07a9c7d62018/documents/ec6d89ae-6e1c-4d15-9ee5-6e6536d8da8a_00f356a0-401e-4b6b-8307-f9f183471ecd.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,4-Hexadienoic acid, 1,1’-[2-ethyl-2-[[(1-oxo-2,4-hexadien-1-yl)oxy]methyl]-1,3-propanediyl] ester",347377-00-8," Acute Oral Toxicity: The purpose of thein silico study was to predict the Acute Oral Toxicity of the test item Trimethylolpropane trisorbate based on a weight of evidence approach. This prediction was performed using the following QSAR models. ·       Leadscope Model Applier v2.4.1-36 ·       US EPA Toxicity Estimation Software Tool (TEST) v4.2.1 ·       iSafeRat®Mechanisms of Action tool Using multiple QSAR models, i.e., Using the US EPA TEST v4.2.1 a predicted acute oral rat LD50value of 5754 mg/kg bw was determined. All the five binary computational models integrated into the Leadscope Model Applier v2.4.1-36 provided negative predictions for Acute Oral toxicity. The query substance was within the applicability domain of Leadscope Model Applier. A negative prediction implies that no structural alerts for acute oral toxicity were matched for the query chemical. This model does not predict a LD50value. iSafeRat®Mechanisms of Action tool predicts that the stomach will promote rapid hydrolysis of the substance at the ester bonds. The hydrolysis products will be trimetylolpropane and sorbate, both of which are known to have low toxicity. The final acute oral toxicity was predicted by applying a consensus method to the results derived from the individual models. The Acute Oral Toxicity (Oral Rat LD50) value predicted for Trimethylolpropane trisorbate is 5754 mg/kg bw, whilst the oral LD50 values for the two major metabolites are both >10,000 mg/kg bw. These results are further supported by the negative predictions for acute oral toxicity derived using the Leadscope Model Applier (non toxic for all GHS categories) and also the results from iSafeRat® Mechanisms of action tool that suggests that the query substance and its metabolites are expected to be non-toxic. There is no reliable evidence to suggest that, under any circumstances, this substance may present a danger to especially vulnerable populations and in this case classification under GHS is not appropriate. Based on this prediction, the substance is not classified under the CLP classification criteria, and also not classified under the GHS classification Criteria for Acute Toxicity. The consensus result is reliable, however, the QSARs used in this report do not currently have the documentation (QMRF and QPRF reports) that is required for reporting a QSAR prediction under REACH sufficient to warrant a Klimisch score of 1, so in this case the result is associated with a Klimisch score of 2. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5570bc38-078f-4e13-9de3-b177fab7a9db/documents/d3b32dca-cd72-4f8a-8044-2b10ae1b9797_4e30531c-951a-4f51-b242-a161f046ba05.html,,,,,, "2,4-Hexadienoic acid, 1,1’-[2-ethyl-2-[[(1-oxo-2,4-hexadien-1-yl)oxy]methyl]-1,3-propanediyl] ester",347377-00-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5570bc38-078f-4e13-9de3-b177fab7a9db/documents/d3b32dca-cd72-4f8a-8044-2b10ae1b9797_4e30531c-951a-4f51-b242-a161f046ba05.html,,oral,LD50,"5,754 mg/kg bw",no adverse effect observed, "3-(trimethoxysilyl)propyl (2E,4E)-hexa-2,4-dienoate",163802-53-7," The key study for repeated dose toxicity, conducted according to OECD TG 422 and in compliance with GLP reports a NOAEL of 1000 mg/kg/day (the highest dose level tested) for general toxicity (Harlan Laboratories 2013). ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/77f34d7f-acf0-4d69-b070-d23ce83918c7/documents/b972eb6a-7fd1-447e-9f73-73da9571cb99_95ee4211-64e8-4d43-b6f1-f5dea0433ef7.html,,,,,, "3-(trimethoxysilyl)propyl (2E,4E)-hexa-2,4-dienoate",163802-53-7,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/77f34d7f-acf0-4d69-b070-d23ce83918c7/documents/b972eb6a-7fd1-447e-9f73-73da9571cb99_95ee4211-64e8-4d43-b6f1-f5dea0433ef7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3-(trimethoxysilyl)propyl (2E,4E)-hexa-2,4-dienoate",163802-53-7," Based on the available information from the key acute oral toxicity study, the LD50 (oral, rat) for 3-(trimethoxysilyl)propyl-(2E,4E)-hexa-2,4-dienoate was concluded to be > 2000 mg/kg bw. The study was conducted according to OECD Test Guideline 423 and to GLP (BSL Bioservice 2012a). Based on the available information from the key acute dermal toxicity study, the LD50 (dermal, rat) for 3-(trimethoxysilyl)propyl-(2E,4E)-hexa-2,4-dienoate was concluded to be > 2000 mg/kg bw. The study was conducted according to OECD Test Guideline 423 and to GLP (BSL Bioservice 2013a).  ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77f34d7f-acf0-4d69-b070-d23ce83918c7/documents/3d0c67d6-2998-4257-81ce-226e3f9dd9ef_95ee4211-64e8-4d43-b6f1-f5dea0433ef7.html,,,,,, "3-(trimethoxysilyl)propyl (2E,4E)-hexa-2,4-dienoate",163802-53-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77f34d7f-acf0-4d69-b070-d23ce83918c7/documents/3d0c67d6-2998-4257-81ce-226e3f9dd9ef_95ee4211-64e8-4d43-b6f1-f5dea0433ef7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-(trimethoxysilyl)propyl (2E,4E)-hexa-2,4-dienoate",163802-53-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77f34d7f-acf0-4d69-b070-d23ce83918c7/documents/3d0c67d6-2998-4257-81ce-226e3f9dd9ef_95ee4211-64e8-4d43-b6f1-f5dea0433ef7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,5,7,10,11,14-hexaoxa-1,6-distibabicyclo[4.4.4]tetradecane",29736-75-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63f54360-bd6a-48e1-a33e-2a68b2202e09/documents/8ac7be90-9223-49d0-8bbb-26020f929141_58ad355f-bf9c-4da9-bb35-7ea0791e5cfc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,686 mg/kg bw/day",,rat "2,5,7,10,11,14-hexaoxa-1,6-distibabicyclo[4.4.4]tetradecane",29736-75-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63f54360-bd6a-48e1-a33e-2a68b2202e09/documents/8ac7be90-9223-49d0-8bbb-26020f929141_58ad355f-bf9c-4da9-bb35-7ea0791e5cfc.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.51 mg/m3,no adverse effect observed,rat "2,5,8,11-tetramethyldodec-6-yne-5,8-diol",68227-33-8,"Mortality, physical observations, body weight, and food consumption data, as well as gross necropsy observations did not reveal any adverse effects considered to be attributable to the administration of TMDDD at any of the dose levels.  ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a4274ec-53eb-4136-9739-5f344f657174/documents/IUC5-58b08fbd-d141-4147-880c-398c29eea715_af94b064-4b99-42dc-b522-a6af4a1da42e.html,,,,,, "2,5,8,11-tetramethyldodec-6-yne-5,8-diol",68227-33-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a4274ec-53eb-4136-9739-5f344f657174/documents/IUC5-58b08fbd-d141-4147-880c-398c29eea715_af94b064-4b99-42dc-b522-a6af4a1da42e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "2,5,8,11-tetramethyldodec-6-yne-5,8-diol",68227-33-8,"According to the UN Globally Harmonized System of Classification and Labelling of Chemicals (GHS) Part 3 Chapter 3.1 no classification required, since this substance does not cause concern of acute toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a4274ec-53eb-4136-9739-5f344f657174/documents/IUC5-069598bc-672b-47e8-b045-0a699cafe1a3_af94b064-4b99-42dc-b522-a6af4a1da42e.html,,,,,, "2,5,8,11-tetramethyldodec-6-yne-5,8-diol",68227-33-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a4274ec-53eb-4136-9739-5f344f657174/documents/IUC5-069598bc-672b-47e8-b045-0a699cafe1a3_af94b064-4b99-42dc-b522-a6af4a1da42e.html,,oral,LD50,"12,900 mg/kg bw",no adverse effect observed, "2,5,8,11-tetramethyldodec-6-yne-5,8-diol",68227-33-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a4274ec-53eb-4136-9739-5f344f657174/documents/IUC5-069598bc-672b-47e8-b045-0a699cafe1a3_af94b064-4b99-42dc-b522-a6af4a1da42e.html,,dermal,LD50,> 1 mg/kg bw,no adverse effect observed, "2,5,8,11-tetramethyldodec-6-yne-5,8-diol",68227-33-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a4274ec-53eb-4136-9739-5f344f657174/documents/IUC5-069598bc-672b-47e8-b045-0a699cafe1a3_af94b064-4b99-42dc-b522-a6af4a1da42e.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, "2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone",903-19-5," - Combined repeated dose toxicity and reproductive and developmental toxicity (OECD 422), rat, oral: NOAEL (m, f) = 10 mg/kg bw/day, LOAEL (m, f) = 50 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c7008b5-8cb5-4bc2-9749-1e21c048d7e4/documents/a8cf326b-f5ca-4225-925b-097f4ec11fb6_5b499913-07ab-43c3-b21d-4ff05fa95dff.html,,,,,, "2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone",903-19-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c7008b5-8cb5-4bc2-9749-1e21c048d7e4/documents/a8cf326b-f5ca-4225-925b-097f4ec11fb6_5b499913-07ab-43c3-b21d-4ff05fa95dff.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "2,5-bis(1,1,3,3-tetramethylbutyl)hydroquinone",903-19-5," - Acute oral toxicity, rat (OECD 420): LD50 (m/f) > 2000 mg/kg bw - Acute dermal toxicity, rat (OECD 402): LD50 (m/f) > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c7008b5-8cb5-4bc2-9749-1e21c048d7e4/documents/9d6a904e-38a5-4ff7-b2f5-868de7c2c8d4_5b499913-07ab-43c3-b21d-4ff05fa95dff.html,,,,,, "2,5-bis(p-toluidino)terephthalic acid",10291-28-8,Oral LD50 value for the test item was > 5000 mg/kg bw in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eae4e71e-97aa-4db3-a1f0-06cf150eb83e/documents/IUC5-3376f830-ed5f-41e1-814b-32e41d14df84_a6ca8b80-30c6-4dca-ae36-d661f43e5059.html,,,,,, "2,5-bis-isocyanatomethyl-bicyclo[2.2.1]heptane",74091-64-8,"In a sub-acute (28-d) oral study in rats a NOAEL (systemic effects) of 100 mg/kg bw/day was established based on an increase of liver weights and a reduction in ovary weights in the females and a suppression of body weight gain in males at 500 mg/kg bw/day. In a sub-chronic (90-d) inhalation toxicity study in rats a NOAEC (local effects) of 0.12 mg/m3 was established based on hyperplasia with or without inflammation (rhinitis) in the transitional epithelium and hyperplasia in the respiratory epithelium in males at 0.55 mg/m3. In the same study, a NOAEC (systemic effects) of ≥2.03 mg/m3 (highest dose tested) was established. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ac4b239-064c-47e3-92e2-f8c19732b2eb/documents/IUC5-6055cb96-83b7-453c-9260-63dc5c077e1e_2b3350d5-70b1-4000-89c4-cc5c5c985d21.html,,,,,, "2,5-bis-isocyanatomethyl-bicyclo[2.2.1]heptane",74091-64-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ac4b239-064c-47e3-92e2-f8c19732b2eb/documents/IUC5-6055cb96-83b7-453c-9260-63dc5c077e1e_2b3350d5-70b1-4000-89c4-cc5c5c985d21.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2,5-bis-isocyanatomethyl-bicyclo[2.2.1]heptane",74091-64-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ac4b239-064c-47e3-92e2-f8c19732b2eb/documents/IUC5-6055cb96-83b7-453c-9260-63dc5c077e1e_2b3350d5-70b1-4000-89c4-cc5c5c985d21.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,2.03 mg/m3,,rat "2,5-bis-isocyanatomethyl-bicyclo[2.2.1]heptane",74091-64-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ac4b239-064c-47e3-92e2-f8c19732b2eb/documents/IUC5-6055cb96-83b7-453c-9260-63dc5c077e1e_2b3350d5-70b1-4000-89c4-cc5c5c985d21.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.12 mg/m3,adverse effect observed,rat "2,5-bis-isocyanatomethyl-bicyclo[2.2.1]heptane",74091-64-8,Acute oral toxicity study in rats: LD50 oral: 1842 mg/kg for male rats and 1201 mg/kg for female rats. Acute inhalation toxicity study in rats (male/female): 4h-LC50: 0.054 mg/L. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ac4b239-064c-47e3-92e2-f8c19732b2eb/documents/IUC5-16ccb102-3b64-4394-90f8-a0282d3dc003_2b3350d5-70b1-4000-89c4-cc5c5c985d21.html,,,,,, "2,5-bis-isocyanatomethyl-bicyclo[2.2.1]heptane",74091-64-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ac4b239-064c-47e3-92e2-f8c19732b2eb/documents/IUC5-16ccb102-3b64-4394-90f8-a0282d3dc003_2b3350d5-70b1-4000-89c4-cc5c5c985d21.html,,oral,LD50,"1,201 mg/kg bw",adverse effect observed, "2,5-bis-isocyanatomethyl-bicyclo[2.2.1]heptane",74091-64-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ac4b239-064c-47e3-92e2-f8c19732b2eb/documents/IUC5-16ccb102-3b64-4394-90f8-a0282d3dc003_2b3350d5-70b1-4000-89c4-cc5c5c985d21.html,,inhalation,LC50,54 mg/m3,adverse effect observed, "2,5-cyclohexadien-1-one, 4-[[4-(phenylamino)phenyl]imino]-, reaction products with sodium sulfide (Na2(Sx)), leuco derivatives",12262-26-9," In a study according OECD TG 422 performed with the read across substance Blue Sema (CAS No.1040873 -93 -5) 100, 300 or 1000 mg dye/kg bw/day(corresponding to 0, 115, 345 and 1150 mg test item/kg bw) were administered to rats by oral gavage. Neither signs of systemic toxicity nor adverse influence on the reproductive performance (gonad function, mating behavior, conception, parturition) were detected. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f7425dfd-8a6b-4f08-8ab3-9f8dc32a05fd/documents/53181d53-48a0-4a72-b3f9-c29dda5788b6_a4b9cf70-93a1-4545-84af-44190878f679.html,,,,,, "2,5-cyclohexadien-1-one, 4-[[4-(phenylamino)phenyl]imino]-, reaction products with sodium sulfide (Na2(Sx)), leuco derivatives",12262-26-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f7425dfd-8a6b-4f08-8ab3-9f8dc32a05fd/documents/53181d53-48a0-4a72-b3f9-c29dda5788b6_a4b9cf70-93a1-4545-84af-44190878f679.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,5-cyclohexadien-1-one, 4-[[4-(phenylamino)phenyl]imino]-, reaction products with sodium sulfide (Na2(Sx)), leuco derivatives",12262-26-9," In an acute oral toxicity study (acute toxic class method, ATC) according to OECD guideline 423 an LD50 of above 2000 mg/kg bw was determined (corresponding to > 2280 mg product/kg bw). . ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7425dfd-8a6b-4f08-8ab3-9f8dc32a05fd/documents/b4bdae17-be22-4252-bf91-f7633956579f_a4b9cf70-93a1-4545-84af-44190878f679.html,,,,,, "2,5-cyclohexadien-1-one, 4-[[4-(phenylamino)phenyl]imino]-, reaction products with sodium sulfide (Na2(Sx)), leuco derivatives",12262-26-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7425dfd-8a6b-4f08-8ab3-9f8dc32a05fd/documents/b4bdae17-be22-4252-bf91-f7633956579f_a4b9cf70-93a1-4545-84af-44190878f679.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,5-diaminobenzenesulphonic acid",88-45-9," Repeated dose toxicity: Oral The No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg/day for test substance  in male and female rats during subchronic repeated dose toxicity study. Repeated dose toxicity: inhalation  According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 2,5-diaminobenzenesulphonic acid( 88-45-9), which is reported as 8.700716e-7mmHG.. Thus, exposure to inhalable dust, mist and vapour of the chemical 2,5-diaminobenzenesulphonic acid is highly unlikely. Therefore this study is considered for waiver.   Repeated dose toxicity: dermal The acute toxicity value for 2,5-diaminobenzenesulphonic acid( 88-45-9) (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not irritating to skin. Also, given the use of the chemical as dye intermediate and used for all kinds of dye products; repeated exposure by the dermal route is unlikely. Thus, it is expected that 2,5-diaminobenzenesulphonic acid shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no dermal absorption data as well as no data available that suggests that 2,5-diaminobenzenesulphonic acid shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbf392cb-af5f-430b-a723-004ce62f8bf4/documents/a8632f55-2cd8-4664-86b4-73e280e4edc4_cae00758-17bb-4070-bd05-ab7e29eebd48.html,,,,,, "2,5-diaminobenzenesulphonic acid",88-45-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbf392cb-af5f-430b-a723-004ce62f8bf4/documents/a8632f55-2cd8-4664-86b4-73e280e4edc4_cae00758-17bb-4070-bd05-ab7e29eebd48.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,5-diaminobenzenesulphonic acid",88-45-9," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is 6400 mg/kg bw. The study concluded that LD50 is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 4.98E-9 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: In accordance with ANNEX VII column 2 of the REACH regulation the study need not be conducted if the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5) and the available information indicates that it should be classified as skin corrosion (Category 1, 1A, 1B or 1C). The experimental pH of the test chemical is 1.77. Hence, based on the low pH of the test chemical, the acute dermal study was considered for waiver. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbf392cb-af5f-430b-a723-004ce62f8bf4/documents/7ec10466-7e22-4af3-992e-f0d10ee19558_cae00758-17bb-4070-bd05-ab7e29eebd48.html,,,,,, "2,5-diaminobenzenesulphonic acid",88-45-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbf392cb-af5f-430b-a723-004ce62f8bf4/documents/7ec10466-7e22-4af3-992e-f0d10ee19558_cae00758-17bb-4070-bd05-ab7e29eebd48.html,,oral,LD50,"6,400 mg/kg bw",no adverse effect observed, "2,5-dichloro-4-[[2-(dibutylamino)-4-methyl-6-[[2-(4-sulphophenyl)ethyl]amino]-5-pyrimidinyl]azo]benzenesulphonic acid, sodium salt",84962-50-5, Oral LD50 (female) > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3eba471d-a12d-403a-8a5d-2591a5a3116c/documents/f29913ed-1ada-4c01-9bbd-5a1320d7034c_b0925dc2-7fc0-4039-a5b3-b47f3d034545.html,,,,,, "2,5-dihydrofuran",1708-29-8,A NOAEL for repeated oral toxicity could not be determined. The NOAEC for repeated inhalation toxicity was determined to be 125 ppm (= 358 mg/m3) for systemic and local effects. ,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/80ffb3a7-3af6-4d47-85b5-cd47ad487347/documents/IUC5-f1465d45-0755-4d89-b107-224a180a7baa_9a9fe382-c3be-4ae6-8f8a-afe42f20c0b1.html,,,,,, "2,5-dihydrofuran",1708-29-8,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/80ffb3a7-3af6-4d47-85b5-cd47ad487347/documents/IUC5-f1465d45-0755-4d89-b107-224a180a7baa_9a9fe382-c3be-4ae6-8f8a-afe42f20c0b1.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,358 mg/m3,,rat "2,5-dihydrofuran",1708-29-8,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/80ffb3a7-3af6-4d47-85b5-cd47ad487347/documents/IUC5-f1465d45-0755-4d89-b107-224a180a7baa_9a9fe382-c3be-4ae6-8f8a-afe42f20c0b1.html,Repeated dose toxicity – local effects,inhalation,NOAEC,358 mg/m3,adverse effect observed,rat "2,5-dihydrofuran",1708-29-8,The oral LD50 was determined to be 463 mg/kg.The inhalation LC0 was determined to be 6 mg/l.The dermal LD50 was determined to be >400 mg/kg. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80ffb3a7-3af6-4d47-85b5-cd47ad487347/documents/IUC5-97006eae-4e81-4adf-b448-1adc5a9adfa3_9a9fe382-c3be-4ae6-8f8a-afe42f20c0b1.html,,,,,, "2,5-dihydrofuran",1708-29-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80ffb3a7-3af6-4d47-85b5-cd47ad487347/documents/IUC5-97006eae-4e81-4adf-b448-1adc5a9adfa3_9a9fe382-c3be-4ae6-8f8a-afe42f20c0b1.html,,oral,LD50,463 mg/kg bw,adverse effect observed, "2,5-dimethoxyaniline",102-56-7,Acute oral toxicity according to a guideline similar OECD 401: LD50: 578 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1473ce7b-7fb9-410a-ade1-19cd98095bc8/documents/IUC5-b1946d8f-2cf6-4cb0-9e76-01a419cce901_2fe42140-f03c-48ea-8f51-38d9061a328a.html,,,,,, "2,5-dimethoxyaniline",102-56-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1473ce7b-7fb9-410a-ade1-19cd98095bc8/documents/IUC5-b1946d8f-2cf6-4cb0-9e76-01a419cce901_2fe42140-f03c-48ea-8f51-38d9061a328a.html,,oral,LD50,578 mg/kg bw,, "2,5-di-tert-butyl-p-benzoquinone",2460-77-7," The purpose of the study was to evaluate the potential toxic effect of the Test Item 2,5-Di-tert-butyl- 1,4-benzoquinone when administered as a single oral dose to Wistar rats. The procedure according to OECD Guideline 423 Acute Toxic Class (ATC) method was used. Available information indicated that the Test Item is likely to be non-toxic; therefore, a limit dose of 2000 mg/kg body weight was used as a starting dose. At the dose of 2000 mg/kg bw signs of toxicity was observed on Day 2 after administration. On Day 5 two animals were found dead. One died on Day 3. On Day 6 the rest of the animals were sacrificed due to ethical reasons. At dose of 300 mg/kg bw no mortalities were found. At dose of 2000 mg/kg bw four animals were sleepy and lethargic. On Day 3 and after mild tremor and hyperaemia of eyes, ears and mouth were observed in all animals. At dose of 300 mg/kg bw animals were lethargic from Day 1 to Day 6. On the subsequent days, negative reactions were not registered. Body weights were reduced in the group of 2000 mg/kg bw, at week 1 (three animals ). No body weigh changes were observed in the group of 300 mg/kg bw. To examine gross pathology in the animals of 2000 mg/kg bw group animals 1-3 could not be necropsied because of cadavers were autolyzed. Animals 4-6 were found to have pronounced hyperaemia of extremities, ears, eyes and mouth and hypertrophy of both adrenals (diameter about 5-7 mm) was recorded. In animals of 300 mg/kg bw group no findings macroscopic findings at necropsy. Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that the 2,5-Di-tert-butyl-1,4-benzoquinone is classified in Category 4 with a LD50 cut off value 500 mg/kg body weight, after single oral administration to Wistar rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6a75609-945c-45cf-b8ac-58fbaa92a3a2/documents/84b81fe0-9352-419b-a8fd-3c1356acd29e_f9e10f54-93a6-4088-8b58-54dd625a058c.html,,,,,, "2,5-di-tert-butyl-p-benzoquinone",2460-77-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6a75609-945c-45cf-b8ac-58fbaa92a3a2/documents/84b81fe0-9352-419b-a8fd-3c1356acd29e_f9e10f54-93a6-4088-8b58-54dd625a058c.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.",68784-12-3,OECD 422 (GLP): NOAEL (males) = 100 mg/kg bw/dOECD 408 (GLP): NOAEL (males/females) = 300 mg/kg bw/dOECD 443 (GLP): NOAEL (males/females) = 100 mg/kg bw/d ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/90ae88ff-5fac-4053-964e-12d9739d04c5/documents/IUC5-138bd8e7-8d16-48a3-8136-d257deb12553_3e27b7bc-808a-438d-ae7f-5205b46fc67c.html,,,,,, "2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.",68784-12-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/90ae88ff-5fac-4053-964e-12d9739d04c5/documents/IUC5-138bd8e7-8d16-48a3-8136-d257deb12553_3e27b7bc-808a-438d-ae7f-5205b46fc67c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.",68784-12-3,- Oral (rat): > 2000 mg/kg bw (f) (OECD 423)- Dermal (rat): >2000 mg/kg bw (m+f) (OECD 402) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90ae88ff-5fac-4053-964e-12d9739d04c5/documents/IUC5-671dc270-762d-455a-8a2b-d65400796df2_3e27b7bc-808a-438d-ae7f-5205b46fc67c.html,,,,,, "2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.",68784-12-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90ae88ff-5fac-4053-964e-12d9739d04c5/documents/IUC5-671dc270-762d-455a-8a2b-d65400796df2_3e27b7bc-808a-438d-ae7f-5205b46fc67c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,5-Furandione, dihydro-, mono-C15-20-alkenyl derivs.",68784-12-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90ae88ff-5fac-4053-964e-12d9739d04c5/documents/IUC5-671dc270-762d-455a-8a2b-d65400796df2_3e27b7bc-808a-438d-ae7f-5205b46fc67c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "(3-(C20-24-(even numbered)-alkyl-2-enyl)-dihydro-furan-2,5-dion",70983-53-8, Acute toxicity oral (rat): LD50>11710.7 mg/kg boday weight ((Q)SAR Prediction). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a61a3f59-ddb5-4579-b4da-445ba52db31f/documents/c202647c-6bd8-43d2-9466-76daa338f78b_c72d7d1c-7101-4693-89a6-4bcb75f136bd.html,,,,,, "(3-(C20-24-(even numbered)-alkyl-2-enyl)-dihydro-furan-2,5-dion",70983-53-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a61a3f59-ddb5-4579-b4da-445ba52db31f/documents/c202647c-6bd8-43d2-9466-76daa338f78b_c72d7d1c-7101-4693-89a6-4bcb75f136bd.html,,oral,LD50,"11,710.7 mg/kg bw",no adverse effect observed, "2,5-thiophenediylbis(5-tert-butyl-1,3-benzoxazole)",7128-64-5," Several studies with repeated expoure are available in both rats and dogs. The most sensitive species was the rat, based on the mild liver weight increase observed at the highest dose level of 3000 ppm after 90 days of treatment. This effect was not observed in dogs after 90 days, even at the highest dose level of 50000 ppm. Since the described effects on the liver in rats were mild and not accompanied by histological changes, this effect is considered as adaptive and the highest feeding level of 10000 ppm is therefore considered the NOAEL, corresponding to 707 mg/kg bw in males and 788 mg/kg bw in females. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eea21928-8978-42df-a0e3-cf4f35afeb47/documents/IUC5-651ea968-ad5a-4020-bd97-ed35bc8ac7d0_b0623678-f471-48f0-a6f4-f9f6d461b7bf.html,,,,,, "2,5-thiophenediylbis(5-tert-butyl-1,3-benzoxazole)",7128-64-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eea21928-8978-42df-a0e3-cf4f35afeb47/documents/IUC5-651ea968-ad5a-4020-bd97-ed35bc8ac7d0_b0623678-f471-48f0-a6f4-f9f6d461b7bf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,707 mg/kg bw/day,,rat "2,5-thiophenediylbis(5-tert-butyl-1,3-benzoxazole)",7128-64-5," The oral LD50 was determined to be greater than 10000 mg/kg bw. Responses to the administered test substance were negligible. No deaths occurred at any dosage levels used. The LC50 by inhalation determined after an observation period of 14 days in rats of both sexes, exposed to the substance for four hours is greater than 1820 mg/m3 (highest concentration possible). No toxic symptoms were observed. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eea21928-8978-42df-a0e3-cf4f35afeb47/documents/IUC5-10c10e3b-fac6-4f5e-8d60-979d0138856d_b0623678-f471-48f0-a6f4-f9f6d461b7bf.html,,,,,, "2,5-thiophenediylbis(5-tert-butyl-1,3-benzoxazole)",7128-64-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eea21928-8978-42df-a0e3-cf4f35afeb47/documents/IUC5-10c10e3b-fac6-4f5e-8d60-979d0138856d_b0623678-f471-48f0-a6f4-f9f6d461b7bf.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "2,5-thiophenediylbis(5-tert-butyl-1,3-benzoxazole)",7128-64-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eea21928-8978-42df-a0e3-cf4f35afeb47/documents/IUC5-10c10e3b-fac6-4f5e-8d60-979d0138856d_b0623678-f471-48f0-a6f4-f9f6d461b7bf.html,,inhalation,LC50,"1,820 mg/m3",no adverse effect observed, "2,6-bis(1,1-dimethylethyl)-4-(phenylenemethylene)cyclohexa-2,5-dien-1-one",7078-98-0,Repeated Dose 28-day Oral Toxicity: The No-Observable Adverse Effect Level (NOAEL) for the test material in both males and females is 300 mg/kg/day. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2543c20a-0fbc-44dc-93eb-2e3602c91510/documents/IUC5-06556de6-8c06-40c1-b835-e29963b89adf_b54cff6e-cad2-4267-b3b4-42756dec64f7.html,,,,,, "2,6-bis(1,1-dimethylethyl)-4-(phenylenemethylene)cyclohexa-2,5-dien-1-one",7078-98-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2543c20a-0fbc-44dc-93eb-2e3602c91510/documents/IUC5-06556de6-8c06-40c1-b835-e29963b89adf_b54cff6e-cad2-4267-b3b4-42756dec64f7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2,6-bis(1,1-dimethylethyl)-4-(phenylenemethylene)cyclohexa-2,5-dien-1-one",7078-98-0,Acute Oral Toxicity: The LD50 is greater than 5000 mg/kg.Acute Dermal Toxicity: The LD50 is greater than 2000 mg/kg. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2543c20a-0fbc-44dc-93eb-2e3602c91510/documents/IUC5-3fd0c859-0555-4590-8437-b39ce573858b_b54cff6e-cad2-4267-b3b4-42756dec64f7.html,,,,,, "2,6-bis(1,1-dimethylethyl)-4-(phenylenemethylene)cyclohexa-2,5-dien-1-one",7078-98-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2543c20a-0fbc-44dc-93eb-2e3602c91510/documents/IUC5-3fd0c859-0555-4590-8437-b39ce573858b_b54cff6e-cad2-4267-b3b4-42756dec64f7.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,6-bis(1,1-dimethylethyl)-4-(phenylenemethylene)cyclohexa-2,5-dien-1-one",7078-98-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2543c20a-0fbc-44dc-93eb-2e3602c91510/documents/IUC5-3fd0c859-0555-4590-8437-b39ce573858b_b54cff6e-cad2-4267-b3b4-42756dec64f7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol",79072-96-1," The following test data has been used to assess the repeated dose toxicity of the substance. - 13-week oral toxicity test (oral feed) in rats and mice on target substance (EC 406-176-9). - reading across the results of a 28-day repeated dose toxicity study conducted on a structurally similar analogue substance (EC 413-110-2). 13-week oral toxicity test (oral feed) in rats and mice on target substance (EC 406-176-9). In a 13-week repeated dose toxicity oral feed study, rats were treated at concentrations up to 50000 ppm. No significant adverse toxic effects were observed at 50000 ppm in the parameters examined. The NOAEL is considered to be 50000 ppm; equivalent to 3020 mg/kg bw/day in males and 3240 mg/kg bw/day in females. In a 13-week repeated dose toxicity oral feed study, mice were treated at concentrations up to 50000 ppm. No significant adverse toxic effects were observed at 50000 ppm in the parameters examined. The NOAEL is considered to be 50000 ppm; equivalent to 7280 mg/kg bw/day in males and 10710 mg/kg bw/day in females. 28 -day repeated dose toxicity study: Source Substance; 1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol (EC-413 -110 -2): A 28-day repeated-dose oral toxicity study of the test material followed by a 14-day recovery test was conducted in male and female Crj: CD (SD) rats (6/sex/ group), 5 weeks of age at the start of dosing. The highest dose was set at 1000 mg/kg, and 3 lower doses at 200, 40 and 8 mg/kg. Recovery groups were separately provided for vehicle control and 1000 mg/kg groups. There were no deaths on account of administration of the test material. No abnormalities were noted in general conditions, body weights, food consumption, haematological examinations, blood chemical examinations, urinalysis, necropsy and histopathological examinations. In organ weights, increased absolute and relative liver weights were noted in males of the 1000 mg/kg group. In the recovery test, no abnormalities were noted. In conclusion, No Observed Effect Level of the test material for rats was considered to be 200 mg/kg/day under the conditions tested. The No Observed Adverse Effect Level was considered to be 1000 mg/kg/day. It is proposed that this result can be used in the assessment of the target substance (EC 406-176-9) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f894f119-b5b8-4b33-bcf9-5a726ff393da/documents/e0cf93dc-6132-498c-9e80-8f20252e3a08_8021e10f-057d-4173-ab9f-99d0a81e5d1f.html,,,,,, "2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol",79072-96-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f894f119-b5b8-4b33-bcf9-5a726ff393da/documents/e0cf93dc-6132-498c-9e80-8f20252e3a08_8021e10f-057d-4173-ab9f-99d0a81e5d1f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol",79072-96-1," Acute Oral Toxicity: The test material was determined to have an acute oral toxicity LD50 of >15000 mg/kg bw (in rats). No deaths were observed. Acute Dermal Toxicity: The acute dermal toxicity of the substance (EC 406-176-9) has been assessed by a OECD 402 study on substance itself and supported by reading across the results of studies conducted on two structurally similar analgoue substances. It is proposed that these results can be used in the assessment of the target substance (EC 406-176-9). OECD 402 study on target substance (EC 406-176-9): The acute dermal median lethal dose (LD50) of the test material in guinea pigs was found to be > 2000 mg/kg bodyweight. In 5 female and 5 male animals tested at 2000 mg/kg bodyweight there was no mortality observed and no clinical signs of systemic toxicity. Source Substance; 1,3:2,4-bis-O-(3,4-dimethylbenzylidene)-D-glucitol (EC-413 -110 -2): A study was performed to assess the acute dermal toxicity of the test material (EC 413-110-2) in the Sprague-Dawley CD strain rat. A group of 10 animals (5 males and 5 females) was given a single 24-hour, semi-occluded dermal application to intact skin at a dose level of 2000 mg/kg bodyweight. The animals were observed for 14 days after the day of treatment and were then killed for gross pathological examination. There were no deaths. No signs of systemic toxicity or skin irritation were noted during the study. All animals showed an expected gain in bodyweight during the study. No abnormalities were noted at necropsy. The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be > 2000 mg/kg bodyweight. Source Substance; 1-(2,6-bis(4-tolyl)-1,3-dioxano(5,4-d)-1,3-dioxan-4-yl)ethane-1,2-diol (EC 402-950-5): The purpose of the study is to determine the acute dermal toxicity of technical GEL-ALL-MD (EC 402-950-5) to the rat. Groups of 5 male and 5 female Sprague-Dawley rats received a single, 24 hour occluded, topical application of 2100 mg Technical Gel-ALL-MD/kg bodyweight, moistened with 0.5% w/v sodium carboxymethylcellulose in distilled water. A further 5 male and 5 female control animals were treated similarly except that no test material was applied to the skin. Animals were observed for 14 days after treatment and then examined post mortem. There were no mortalities, no treatment-related clinical signs and no evidence of skin irritation. No treatment-related effects on bodyweight were recorded and no abnormalities were seen post-mortem. In both sexes the acute dermal LD50 was greater than 2100 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f894f119-b5b8-4b33-bcf9-5a726ff393da/documents/f2eb0f55-9e6b-4957-b891-ea8fd05853e3_8021e10f-057d-4173-ab9f-99d0a81e5d1f.html,,,,,, "2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol",79072-96-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f894f119-b5b8-4b33-bcf9-5a726ff393da/documents/f2eb0f55-9e6b-4957-b891-ea8fd05853e3_8021e10f-057d-4173-ab9f-99d0a81e5d1f.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "2,6-bis(4-ethylphenyl)perhydro-1,3,5,7-tetraoxanaphth-4-ylethane-1,2-diol",79072-96-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f894f119-b5b8-4b33-bcf9-5a726ff393da/documents/f2eb0f55-9e6b-4957-b891-ea8fd05853e3_8021e10f-057d-4173-ab9f-99d0a81e5d1f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,6-bis[[bis(2-hydroxyethyl)amino]methyl]-4-nonylphenol",20073-51-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b44ad16e-4d4d-4d20-a70e-44edb226899a/documents/82ecc1da-f111-4818-b4ec-e75642db141c_2ba8604b-a7ba-4da9-98e4-78e50b0a678b.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,37.5 mg/kg bw/day,,rat "2,6-bis[[bis(2-hydroxyethyl)amino]methyl]-4-nonylphenol",20073-51-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b44ad16e-4d4d-4d20-a70e-44edb226899a/documents/ec900f6b-f101-4af7-83ca-5b5aa079622f_2ba8604b-a7ba-4da9-98e4-78e50b0a678b.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "2,6-bis[[bis(2-hydroxyethyl)amino]methyl]-4-nonylphenol",20073-51-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b44ad16e-4d4d-4d20-a70e-44edb226899a/documents/ec900f6b-f101-4af7-83ca-5b5aa079622f_2ba8604b-a7ba-4da9-98e4-78e50b0a678b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,6-diamino-1H-pyrimidin-4-one",56-06-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/61a637ba-3284-4e98-b6b5-38507f7cf945/documents/IUC5-b2b90227-291c-42d6-b15c-8da6f976489b_bbd67636-589c-4dcb-919d-1cbd8f646417.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "2,6-diamino-1H-pyrimidin-4-one",56-06-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Information is available from the full public report issued by the Australian competent authority (NICNAS); it is therefore assumed to provide reliable information. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Information is available from the full public report issued by the Australian competent authority (NICNAS); it is therefore assumed to provide reliable information. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61a637ba-3284-4e98-b6b5-38507f7cf945/documents/IUC5-95cdb5cd-c3bb-4a08-a9ab-1c7bd986d07c_bbd67636-589c-4dcb-919d-1cbd8f646417.html,,,,,, "2,6-diamino-1H-pyrimidin-4-one",56-06-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61a637ba-3284-4e98-b6b5-38507f7cf945/documents/IUC5-95cdb5cd-c3bb-4a08-a9ab-1c7bd986d07c_bbd67636-589c-4dcb-919d-1cbd8f646417.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2,6-diamino-1H-pyrimidin-4-one",56-06-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61a637ba-3284-4e98-b6b5-38507f7cf945/documents/IUC5-95cdb5cd-c3bb-4a08-a9ab-1c7bd986d07c_bbd67636-589c-4dcb-919d-1cbd8f646417.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,6-dibromo-4-cyanophenyl heptanoate",56634-95-8," Oral subchronic toxicity Key, source, RA-A, CAS 1689-84-5, M-344535-01-1; subchronic (90 d, rat, similar to OECD 408, GLP): NOAEL (systemic): 50 ppm (corresponding to 4.4 mg/kg bw/day for males and 4.9 mg/kg bw/day for females, respectively) LOAEL (systemic): 400 ppm (corresponding to 39.4 mg/kg bw/day for males and 41.6 mg/kg bw/day for females, respectively)   Key, source, RA-A, CAS 1689-84-5, M-229656-01-1; subchronic (90 d, mouse, similar to OECD 408, GLP): NOAEL (systemic): 30 ppm (corresponding to 5.1 mg/kg bw/day for males and 6.4 mg/kg bw/day for females, respectively) LOAEL (systemic): 100 ppm (corresponding to 18.5 mg/kg bw/day for males and 14.7 mg/kg bw/day for females, respectively)   Key; source, RA-A, CAS 1689-84-5, M-231742-02-1; subchronic (90 d, dog, similar to OECD 409, GLP): NOAEL (systemic): 1 mg/kg bw/day (males and females) LOAEL (systemic): 5 mg/kg bw/day (males and females)   Oral chronic toxicity Key, source, RA-A, CAS 1689-84-5, M-240-237-03-1; chronic (52 wks, dog, similar to OECD 452, GLP): NOAEL (systemic): 0.3 mg/kg bw/day (males and females) LOAEL (systemic): 1.5 mg/kg bw/day (males and females) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d386e44-8a0a-46cb-9f52-dad1a16a93c9/documents/33725591-474c-41a6-bdd2-8e37d5b2ecf2_4bb548b4-8332-4fb2-a513-0ea8e53708ba.html,,,,,, "2,6-dibromo-4-cyanophenyl heptanoate",56634-95-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d386e44-8a0a-46cb-9f52-dad1a16a93c9/documents/33725591-474c-41a6-bdd2-8e37d5b2ecf2_4bb548b4-8332-4fb2-a513-0ea8e53708ba.html,Chronic toxicity – systemic effects,oral,NOAEL,0.3 mg/kg bw/day,,dog "2,6-dibromo-4-cyanophenyl heptanoate",56634-95-8," Key, M-280105-01-1; oral (rat, US EPA 81-1, GLP): LD50 = 362.4 mg/kg bw (males), LD50 = 291.9 mg/kg bw (females), LD50 = 322.4 mg/kg bw (combined) Key, M-280109-01-1; inhalation (rat, US EPA 81-3, GLP): LC50 = ca. 1.975 mg/L (males), LC50 = ca. 1.479 mg/L (females), LC50 = ca. 1.7172 mg/L (combined) Key, M-226977-01-1; dermal (rabbit, US EPA 81-2, GLP): LD50 > 2020 mg/kg bw (males and females) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d386e44-8a0a-46cb-9f52-dad1a16a93c9/documents/7db0eb9b-2c20-4919-8815-fff445fa4644_4bb548b4-8332-4fb2-a513-0ea8e53708ba.html,,,,,, "2,6-dibromo-4-cyanophenyl heptanoate",56634-95-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d386e44-8a0a-46cb-9f52-dad1a16a93c9/documents/7db0eb9b-2c20-4919-8815-fff445fa4644_4bb548b4-8332-4fb2-a513-0ea8e53708ba.html,,oral,LD50,292 mg/kg bw,adverse effect observed, "2,6-dibromo-4-cyanophenyl heptanoate",56634-95-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d386e44-8a0a-46cb-9f52-dad1a16a93c9/documents/7db0eb9b-2c20-4919-8815-fff445fa4644_4bb548b4-8332-4fb2-a513-0ea8e53708ba.html,,dermal,LD50,"> 2,020 mg/kg bw",no adverse effect observed, "2,6-dibromo-4-cyanophenyl heptanoate",56634-95-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d386e44-8a0a-46cb-9f52-dad1a16a93c9/documents/7db0eb9b-2c20-4919-8815-fff445fa4644_4bb548b4-8332-4fb2-a513-0ea8e53708ba.html,,inhalation,LC50,1.72 mg/L,adverse effect observed, "2,6-dichlorobenzoxazole",3621-82-7,"acute oral, rat, study conducted according to OECD test guideline 401, result: LD50 = 806 mg/kg bw (females); 880 mg/kg bw (males) acute dermal, rat, study conducted according to OECD test guideline 402, result: LD50 = 1000 mg/kg bw (females) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbb67e89-21ae-425e-b8e6-57d264fae9ef/documents/6ea22f4a-5e7b-4282-9fb7-a9827f739d80_88bbff9c-26c0-43cf-8f3e-b249ecd90cbb.html,,,,,, "2,6-dichlorobenzoxazole",3621-82-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbb67e89-21ae-425e-b8e6-57d264fae9ef/documents/6ea22f4a-5e7b-4282-9fb7-a9827f739d80_88bbff9c-26c0-43cf-8f3e-b249ecd90cbb.html,,oral,LD50,806 mg/kg bw,adverse effect observed, "2,6-dichlorobenzoxazole",3621-82-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbb67e89-21ae-425e-b8e6-57d264fae9ef/documents/6ea22f4a-5e7b-4282-9fb7-a9827f739d80_88bbff9c-26c0-43cf-8f3e-b249ecd90cbb.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, "2,6-diethyl-p-toluidine",24544-08-9,"The test item was tested in acute studies by oral and dermal application on rats. Both studies were conducted in accordance with GLP and following OECD-guidelines. Significant substance-related effects were observed in both tests, therefore the test item needs to be classified as ""harmful"". ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ee1a252-07fd-4c8a-b184-1d2a4fd83d3f/documents/IUC5-88ee799d-8400-4d7a-bf62-c8f4cd7b503b_bcb89ad4-00fb-4c72-8ff5-0676772d3194.html,,,,,, "2,6-diethyl-p-toluidine",24544-08-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ee1a252-07fd-4c8a-b184-1d2a4fd83d3f/documents/IUC5-88ee799d-8400-4d7a-bf62-c8f4cd7b503b_bcb89ad4-00fb-4c72-8ff5-0676772d3194.html,,oral,LD50,443 mg/kg bw,adverse effect observed, "2,6-diethyl-p-toluidine",24544-08-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ee1a252-07fd-4c8a-b184-1d2a4fd83d3f/documents/IUC5-88ee799d-8400-4d7a-bf62-c8f4cd7b503b_bcb89ad4-00fb-4c72-8ff5-0676772d3194.html,,dermal,LD50,"1,703 mg/kg bw",adverse effect observed, "2,6-difluorobenzonitrile",1897-52-5,"ORALLD50 = 727.7 mg/kg bw (male rat); sound scientific principles; van Eldik, 1975INHALATIONLD50 = > 2.64 g/m3 (4h) male/female rat; OECD 403; Jackosn et al., 1991DERMALLD50 = > 2000 mg/kg bw, male/female rat; EU Method B.3,; Koopman TSM, Busé-Pot TE, 1992 ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84440a69-7303-4479-b8c4-d3e2f61fc576/documents/IUC5-29de3db3-92ed-4d87-a080-5506d5b2780b_c6f0aeea-bdd4-4986-b067-c9b47c70d19d.html,,,,,, "2,6-difluorobenzonitrile",1897-52-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84440a69-7303-4479-b8c4-d3e2f61fc576/documents/IUC5-29de3db3-92ed-4d87-a080-5506d5b2780b_c6f0aeea-bdd4-4986-b067-c9b47c70d19d.html,,oral,LD50,727.7 mg/kg bw,, "2,6-diisopropylaniline",24544-04-5,"In an acute oral toxicity study in rats according to OECD method no. 401, the LD50 was determined to be 40770 mg/kg bw for males and females. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8f24b07-125b-4be1-bdca-a3702ccaf6db/documents/IUC5-b268e8bb-80d3-4e0e-b2d4-a0603c48f452_6dbd154c-3d6b-47bb-9cc5-98bf1bae318e.html,,,,,, "2,6-diisopropylaniline",24544-04-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8f24b07-125b-4be1-bdca-a3702ccaf6db/documents/IUC5-b268e8bb-80d3-4e0e-b2d4-a0603c48f452_6dbd154c-3d6b-47bb-9cc5-98bf1bae318e.html,,oral,LD50,"4,077 mg/kg bw",no adverse effect observed, "2,6-diisopropylnaphthalene",24157-81-1," Subchronic (90 -day) repeated dose toxicity (feeding study, similar OECD 408): NOAEL (rat, m) = 105 mg/kg bw/day; NOAEL (rat, f) = 121 mg/kg bw/day Study performed with 2,6-diisopropylnaphthalene (CAS No. 24157-81-1) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41cf88df-c83f-41cf-95d0-d05a5be580e0/documents/ce53e415-4a8c-458f-ab53-42d8b5de733d_212b0771-ef93-4c7d-89ec-8ddd1c4630c4.html,,,,,, "2,6-diisopropylnaphthalene",24157-81-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41cf88df-c83f-41cf-95d0-d05a5be580e0/documents/ce53e415-4a8c-458f-ab53-42d8b5de733d_212b0771-ef93-4c7d-89ec-8ddd1c4630c4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,105 mg/kg bw/day,,rat "2,6-diisopropylnaphthalene",24157-81-1," Acute oral toxicity (OECD 401): LD50 (rat, m/f) > 5000 mg/kg bw Study performed with 2,6-diisopropylnaphthalene (CAS No. 24157-81-1) Acute inhalation toxicity (OECD 403): LC50 (rat, m/f) > 5.64 mg/L air Read-across from analogue source substance bis(isopropyl)naphthalene (CAS No. 38640-62-9) Acute dermal toxicity (OECD 402): LD50 (rat, m/f) > 4500 mg/kg bw Read-across from analogue source substance bis(isopropyl)naphthalene (CAS No. 38640-62-9) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41cf88df-c83f-41cf-95d0-d05a5be580e0/documents/44d94ef7-4263-46bf-8a71-37c22dd98981_212b0771-ef93-4c7d-89ec-8ddd1c4630c4.html,,,,,, "2,6-dimethyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)cyclohex-2-en-1-ol",1401065-88-0," Oral LD50 > 2000 mg/kg bw (OECD 423, K, Rel.2, class method in rats) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d022e49-fdd4-41f6-aa78-dc475a17b6eb/documents/e1b6dfdf-00a6-4552-813f-f4967a219947_f97ca82f-ad0c-46c8-bbec-d79d75ec072f.html,,,,,, "2,6-dimethyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)cyclohex-2-en-1-ol",1401065-88-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d022e49-fdd4-41f6-aa78-dc475a17b6eb/documents/e1b6dfdf-00a6-4552-813f-f4967a219947_f97ca82f-ad0c-46c8-bbec-d79d75ec072f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,6-dimethylcyclohexylamine",6850-63-1," Based on key study results, the oral LD50 of the test material in rats is >215 and < 261 mg/kg bw(BASF SE 1982), the LC50 (4 h) in male and female rats combined is 3.7 mg/l. No data available for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1816e5f0-bc63-41c2-bb5c-b9def7586f03/documents/IUC5-15f8cbfa-917f-47f8-a1ba-ca3bf1117545_73556f5f-2db0-4205-9563-9a9cb408d2e9.html,,,,,, "2,6-dimethylcyclohexylamine",6850-63-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1816e5f0-bc63-41c2-bb5c-b9def7586f03/documents/IUC5-15f8cbfa-917f-47f8-a1ba-ca3bf1117545_73556f5f-2db0-4205-9563-9a9cb408d2e9.html,,inhalation,LC50,"3,700 mg/m3",adverse effect observed, "2,6-dimethylpyridine",108-48-5," Acute oral toxicity: The lethal dose (LD50) value for acute oral toxicity test was considered to be 810 mg/kg bw,when rats were treated with test chemical orally. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7834bc9b-fe7b-4ef4-97f2-633d47ae0b3c/documents/9c15f52e-4dd0-4108-80f7-be74a2afb557_1824a7b7-8989-4b57-8df3-64dc4928d641.html,,,,,, "2,6-dimethylpyridine",108-48-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7834bc9b-fe7b-4ef4-97f2-633d47ae0b3c/documents/9c15f52e-4dd0-4108-80f7-be74a2afb557_1824a7b7-8989-4b57-8df3-64dc4928d641.html,,oral,LD50,810 mg/kg bw,adverse effect observed, "2,6-di-tert-butyl-4-nonylphenol",4306-88-1," A dose range finding study- reproduction/ developmental toxicity screening test with 2,6-Di-tert-butyl-4-nonylphenol in male and female Wistar rats with dose levels of 100, 300, and 1000 mg/kg body weight/ day was performed by oral gavage for a treatment period of 54 days, i.e. during 14 days of pre-mating and maximum 14 days of mating in both males and females, during the gestation period and up to post-natal day 3 in females. Males were dosed after the mating period until the minimum total dosing period of 28 days were completed. Animals of an additional control group were handled identically as the dose groups but received corn oil, the vehicle used in this study. No adverse effects of 2,6-Di-tert-butyl-4-nonylphenol were found up to dose level of 1000 mg/kg body weight. However, the fertility index was markedly lower in HD group (33%) compared to control (100%) and the test-item related effect cannot be excluded. Based on the generated data the dose levels 100, 300 and 1000 mg/kg body weight/ day were selected for the main study. A combined repeated dose oral toxicity and reproduction/ developmental toxicity screening test with 2,6-Di-tert-butyl-4-nonylphenol in male and female Wistar rats with dose levels of 100, 300, and 1000 mg/kg body weight day was performed by oral gavage. Female animals were treated up to 63 days, i.e. during 14 days of pre-mating and maximum 14 days of mating in both males and females, during the gestation period and up to post-natal day 12 in females. Males were dosed after the mating period until the minimum total dosing period of 28 days were completed. Animals of an additional control group were handled identically as the dose groups but received corn oil, the vehicle used in this study. Test item related effects on body weight development, food consumption in male and female high-dose group, on haematology, coagulation and clinical biochemistry in male and female mid-dose and high-dose group and organ weights effect in all groups of males and females were observed. Histopathologically, in liver, hepatocellular vacuolation was observed in both surviving and decedent animals. Hepatocyte vacuolation (fatty changes) was observed in all dose groups and in both males and females. The observed hepatic change indicates hepatocyte functional alteration / disturbances related to the administration of 2,6-Di-tert-butyl-4-nonylphenol and the observed hepatic changes were considered to be adverse. The LOAEL (Low Observed Adverse Effect Level) of 2,6-Di-tert-butyl-4-nonylphenol in this study for general toxicity is considered to be 100 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/788e3a14-5b98-4c49-8523-cc7538c74a01/documents/2729ad11-a993-4bbc-8c7b-57abed8b555a_5dd4a85d-c3c4-4104-9f18-fe3770c26331.html,,,,,, "2,6-di-tert-butyl-4-nonylphenol",4306-88-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/788e3a14-5b98-4c49-8523-cc7538c74a01/documents/2729ad11-a993-4bbc-8c7b-57abed8b555a_5dd4a85d-c3c4-4104-9f18-fe3770c26331.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat "2,6-di-tert-butyl-4-nonylphenol",4306-88-1," In a key acute oral toxicity test according to OECD Guideline 401 a group of ten fasted Sprague-Dawley CD strain rats (five males and five females) was given a single oral dose of undiluted test material at a dose level of 2000 mg/kg bodyweight by gavage. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD-strain rat was found to be greater than 2000 mg/kg body weight. Acute inhalation toxicity testing was waived based on low vapour pressure. In a key acute dermal toxicity study 5 male and 5 female WISTAR Crl: WI(Han) rats were tested according to OECD Guideline 402. The test item was applied semi-occlusive to the dorsal area of the trunk for a 24 -hour exposure period. Under the conditions of the present study, single dermal application of the test item 2,6-Di-tert-butyl-4-nonylphenol to rats at a dose of 2000 mg/kg body weight was not associated with mortality and there were no signs of toxicity but slight signs of irritation. The dermal LD50 was determined to be >2000 mg 2,6-Di-tert-butyl-4-nonylphenol /kg body weight.   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/788e3a14-5b98-4c49-8523-cc7538c74a01/documents/85cbd603-93fb-40b6-a260-c543b669b7f7_5dd4a85d-c3c4-4104-9f18-fe3770c26331.html,,,,,, "2,6-di-tert-butyl-4-nonylphenol",4306-88-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/788e3a14-5b98-4c49-8523-cc7538c74a01/documents/85cbd603-93fb-40b6-a260-c543b669b7f7_5dd4a85d-c3c4-4104-9f18-fe3770c26331.html,,oral,LD50,"2,000 mg/kg bw",, "2,6-di-tert-butyl-4-nonylphenol",4306-88-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/788e3a14-5b98-4c49-8523-cc7538c74a01/documents/85cbd603-93fb-40b6-a260-c543b669b7f7_5dd4a85d-c3c4-4104-9f18-fe3770c26331.html,,dermal,LD50,"2,000 mg/kg bw",, "2,6-di-tert-butylphenol",128-39-2," A key 28-day toxicity study was conducted in Wistar rats by oral gavage at 15, 100 and 600 mg/kg/day. A NOAEL of 100 mg/kg/day was established. At 600 mg/kg/day serum changes were noted (increased total protein in males and females; increased albumin in males; decreased urea in females; decreased inorganic phosphate and increased calcium in females). Enlarged caecum was noted in males and females and incidentally occurring findings included enlarged liver, enlarged kidneys and swollen limiting ridge in the stomach. Increased liver weights were noted in males and females and increased kidney weights were noted in males only. A microscopically observed very slight increase of hepatocellular hypertrophy in the centrilobular area of the liver was noted in males and females and increased slight accumulations of eosinophilic inclusion bodies were noted in the renal cotex of males. A key 90-day toxicity study with 28-day recovery period was conducted in the Han Wistar rat at 0, 150, 500, 1600 or 4000 ppm, corresponding to 0, 10, 33, 107 and 270 mg/kg bw/day in males and 0, 11, 39, 124 and 298 mg/kg bw/day in females. A NOAEL of 270 mg/kg/day was established, which is the highest dose given. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c893cb0-b84d-425f-817b-6f99c3d91334/documents/3b2c819c-8eea-4ab9-a9d2-b7ddddfe8d0e_5de55ea2-fe08-4762-b2ce-54ee43176fa3.html,,,,,, "2,6-di-tert-butylphenol",128-39-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c893cb0-b84d-425f-817b-6f99c3d91334/documents/3b2c819c-8eea-4ab9-a9d2-b7ddddfe8d0e_5de55ea2-fe08-4762-b2ce-54ee43176fa3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,270 mg/kg bw/day,,rat "2,6-di-tert-butylphenol",128-39-2, Acute toxicity oral: LD50 > 5000 mg/kg bodyweight (OECD 401) Acute toxicity dermal: LD50 > 5000 mg/kg bodyweight (non-guideline) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c893cb0-b84d-425f-817b-6f99c3d91334/documents/fc529a4a-49ae-4ff0-9510-8227b9d5cf14_5de55ea2-fe08-4762-b2ce-54ee43176fa3.html,,,,,, "2,6-di-tert-butylphenol",128-39-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c893cb0-b84d-425f-817b-6f99c3d91334/documents/fc529a4a-49ae-4ff0-9510-8227b9d5cf14_5de55ea2-fe08-4762-b2ce-54ee43176fa3.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,6-di-tert-butylphenol",128-39-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c893cb0-b84d-425f-817b-6f99c3d91334/documents/fc529a4a-49ae-4ff0-9510-8227b9d5cf14_5de55ea2-fe08-4762-b2ce-54ee43176fa3.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "2,6-di-tert-butyl-α-dimethylamino-p-cresol",88-27-7,"The study with the longest duration and lowest NOAEL was chosen as key study (read-across approach).Klimisch 2. Read-across approach. The analogue CAS No. 128-37-0 (BHT) which shares the same functional group (alkylphenol) with the substance CAS no. 88-27-7 (2,6-di-tert-butyl-α-dimethylamino-p-cresol), also has comparable values for the relevant molecular properties. Therefore, the results obtained with the substance CAS No. 128 -37-0 can be used for the read-across approach. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6c0ecca-729c-43bd-a56a-cae628c1e59d/documents/IUC5-3f237fc2-63f4-4984-9ed2-2a47c70c4988_d6964d80-940a-499d-b4b3-3e712e5df284.html,,,,,, "2,6-di-tert-butyl-α-dimethylamino-p-cresol",88-27-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6c0ecca-729c-43bd-a56a-cae628c1e59d/documents/IUC5-3f237fc2-63f4-4984-9ed2-2a47c70c4988_d6964d80-940a-499d-b4b3-3e712e5df284.html,Chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "2,6-di-tert-butyl-α-dimethylamino-p-cresol",88-27-7,"Key study: Acute oral: Experimental results: Study performed according to OECD guideline 401 (1981) under GLP-like quality surveillance (QAU statement included)LD50 = 461 mg/kg bwKey study: Acute dermal: Experimental results: Similar to OECD guideline 402. Non-GLP study.LD50 > 4000 mg/kg bwAcute inhalation: Data waiving: In accordance with column 2 of REACH Annex VIII, the study does not need to be conducted since exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6c0ecca-729c-43bd-a56a-cae628c1e59d/documents/IUC5-a0779e46-ba8f-4deb-9ad0-1b0e3781ed56_d6964d80-940a-499d-b4b3-3e712e5df284.html,,,,,, "2,6-di-tert-butyl-α-dimethylamino-p-cresol",88-27-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6c0ecca-729c-43bd-a56a-cae628c1e59d/documents/IUC5-a0779e46-ba8f-4deb-9ad0-1b0e3781ed56_d6964d80-940a-499d-b4b3-3e712e5df284.html,,oral,LD50,461 mg/kg bw,adverse effect observed, "2,6-di-tert-butyl-α-dimethylamino-p-cresol",88-27-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6c0ecca-729c-43bd-a56a-cae628c1e59d/documents/IUC5-a0779e46-ba8f-4deb-9ad0-1b0e3781ed56_d6964d80-940a-499d-b4b3-3e712e5df284.html,,dermal,discriminating dose,"4,000 mg/kg bw",no adverse effect observed, "trisodium 3-amino-4-[(E)-(4-amino-2-sulfonatophenyl)diazenyl]-5-hydroxynaphthalene-2,7-disulfonate",220380-44-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3380c26b-037a-43bd-bade-f9f8d25f019f/documents/IUC5-f976c7e0-1d3a-45f0-959e-b016b5242f7c_7b883ddf-bd66-4049-8a05-8a76e9cd5fa8.html,,oral,LD50,"4,000 mg/kg bw",no adverse effect observed, "Disodium 4-amino-3,6-bis{[4-(ethenylsulfonyl)phenyl]diazenyl}-5-hydroxynaphthalene-2,7-disulfonate",100556-82-9,No adverse effects observed after repeated administration. ,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa1ab29b-ab82-43ba-8d59-4b78bcc5b872/documents/IUC5-84280bf7-b8a3-4d8d-a00d-e714a73f1f05_b623bf87-a738-4ba5-b7cd-4dd44d1e4022.html,,,,,, "Disodium 4-amino-3,6-bis{[4-(ethenylsulfonyl)phenyl]diazenyl}-5-hydroxynaphthalene-2,7-disulfonate",100556-82-9,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa1ab29b-ab82-43ba-8d59-4b78bcc5b872/documents/IUC5-84280bf7-b8a3-4d8d-a00d-e714a73f1f05_b623bf87-a738-4ba5-b7cd-4dd44d1e4022.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Disodium 4-amino-3,6-bis{[4-(ethenylsulfonyl)phenyl]diazenyl}-5-hydroxynaphthalene-2,7-disulfonate",100556-82-9,The test substance is practically non-toxic. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa1ab29b-ab82-43ba-8d59-4b78bcc5b872/documents/IUC5-7531332c-2cff-49b3-a6c4-afbea11d39c7_b623bf87-a738-4ba5-b7cd-4dd44d1e4022.html,,,,,, "Disodium 4-amino-3,6-bis{[4-(ethenylsulfonyl)phenyl]diazenyl}-5-hydroxynaphthalene-2,7-disulfonate",100556-82-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa1ab29b-ab82-43ba-8d59-4b78bcc5b872/documents/IUC5-7531332c-2cff-49b3-a6c4-afbea11d39c7_b623bf87-a738-4ba5-b7cd-4dd44d1e4022.html,,oral,LD50,"14,000 mg/kg bw",no adverse effect observed, "2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, coupled with 3-aminophenol, diazotized 5-amino-2-[(4-aminophenyl)amino]benzenesulfonic acid and diazotized benzenamine, sodium salts",93281-13-1," NOAEL (subacute) (rat, male and female): 350 mg/kg bw/day, systemic toxicity ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/316baa92-d6b1-402b-865d-894438f0a3fb/documents/050e867f-2c49-4834-9358-9074bcd1e3e2_2e2584a8-f4d6-464a-9bbb-d96c7587a2e4.html,,,,,, "2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, coupled with 3-aminophenol, diazotized 5-amino-2-[(4-aminophenyl)amino]benzenesulfonic acid and diazotized benzenamine, sodium salts",93281-13-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/316baa92-d6b1-402b-865d-894438f0a3fb/documents/050e867f-2c49-4834-9358-9074bcd1e3e2_2e2584a8-f4d6-464a-9bbb-d96c7587a2e4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,350 mg/kg bw/day,,rat "2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, coupled with 3-aminophenol, diazotized 5-amino-2-[(4-aminophenyl)amino]benzenesulfonic acid and diazotized benzenamine, sodium salts",93281-13-1, Not harmful/toxic if swallowed Not harmful/toxic in contact with skin ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/316baa92-d6b1-402b-865d-894438f0a3fb/documents/3e8a683a-f2b4-4a8e-95e5-0598beda0db0_2e2584a8-f4d6-464a-9bbb-d96c7587a2e4.html,,,,,, "2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, coupled with 3-aminophenol, diazotized 5-amino-2-[(4-aminophenyl)amino]benzenesulfonic acid and diazotized benzenamine, sodium salts",93281-13-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/316baa92-d6b1-402b-865d-894438f0a3fb/documents/3e8a683a-f2b4-4a8e-95e5-0598beda0db0_2e2584a8-f4d6-464a-9bbb-d96c7587a2e4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, coupled with 3-aminophenol, diazotized 5-amino-2-[(4-aminophenyl)amino]benzenesulfonic acid and diazotized benzenamine, sodium salts",93281-13-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/316baa92-d6b1-402b-865d-894438f0a3fb/documents/3e8a683a-f2b4-4a8e-95e5-0598beda0db0_2e2584a8-f4d6-464a-9bbb-d96c7587a2e4.html,,dermal,LD50,"2,000 ",no adverse effect observed, "2,7-naphthalenedisulfonic acid, 4-amino-5-hydroxy-, diazotized, coupled with diazotized 2-amino-4,6-dinitrophenol, diazotized 4-nitrobenzenamine and resorcinol, sodium salts",8011-86-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c9cacf6-7aa7-4272-88df-c61394aaa4ba/documents/IUC5-97919d77-6e4b-4efd-bc96-236762e1dadc_265a49dd-ce1d-48a5-b944-7d12e6566932.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,70 mg/kg bw/day,,rat "2,7-naphthalenedisulfonic acid, 4-amino-5-hydroxy-, diazotized, coupled with diazotized 2-amino-4,6-dinitrophenol, diazotized 4-nitrobenzenamine and resorcinol, sodium salts",8011-86-7, LD50 oral acute rat > 2000 mg/Kg bw (test item) LD50 dermal acut rat > 2000 mg/Kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c9cacf6-7aa7-4272-88df-c61394aaa4ba/documents/IUC5-3b8ad73f-59e9-4b5b-81a9-9da6ed3c8ce0_265a49dd-ce1d-48a5-b944-7d12e6566932.html,,,,,, "2,7-naphthalenedisulfonic acid, 4-amino-5-hydroxy-, diazotized, coupled with diazotized 2-amino-4,6-dinitrophenol, diazotized 4-nitrobenzenamine and resorcinol, sodium salts",8011-86-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c9cacf6-7aa7-4272-88df-c61394aaa4ba/documents/IUC5-3b8ad73f-59e9-4b5b-81a9-9da6ed3c8ce0_265a49dd-ce1d-48a5-b944-7d12e6566932.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,7-naphthalenedisulfonic acid, 4-amino-5-hydroxy-, diazotized, coupled with diazotized 2-amino-4,6-dinitrophenol, diazotized 4-nitrobenzenamine and resorcinol, sodium salts",8011-86-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c9cacf6-7aa7-4272-88df-c61394aaa4ba/documents/IUC5-3b8ad73f-59e9-4b5b-81a9-9da6ed3c8ce0_265a49dd-ce1d-48a5-b944-7d12e6566932.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, diazotized, coupled with resorcinol, coupled with diazotized 5-amino-2-(phenylamino)benzenesulfonic acid and diazotized 4-nitrobenzenamine",90432-09-0," LD50 (oral, rat) > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/683ae091-80e4-4677-957e-a8ec22860bfa/documents/f16eb254-d5fb-4695-b1c0-569f703ffed2_1cd9f73a-b554-4ae0-baa8-b2529255a1c2.html,,,,,, "2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-, diazotized, coupled with resorcinol, coupled with diazotized 5-amino-2-(phenylamino)benzenesulfonic acid and diazotized 4-nitrobenzenamine",90432-09-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/683ae091-80e4-4677-957e-a8ec22860bfa/documents/f16eb254-d5fb-4695-b1c0-569f703ffed2_1cd9f73a-b554-4ae0-baa8-b2529255a1c2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[2-[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-6-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:5)",1386899-40-6, Acute toxicity: via oral route The LD50of CR SB37 was greater than 2000 mg/kg B.W. (OECD TG423). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a778f7e-21f6-4e2a-a769-bcd6c5aad680/documents/17798c11-9a96-45c8-b3d7-9cfa7c9471a2_3eaa9537-01ea-4a03-bbfa-b6b6eee3ef6c.html,,,,,, "2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[2-[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-6-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:5)",1386899-40-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a778f7e-21f6-4e2a-a769-bcd6c5aad680/documents/17798c11-9a96-45c8-b3d7-9cfa7c9471a2_3eaa9537-01ea-4a03-bbfa-b6b6eee3ef6c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,7-Naphthalenedisulfonic acid, 5-(acetylamino)-3-[2-[5-[[4-chloro-6-[[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-sulfophenyl]diazenyl]-4-hydroxy-, sodium salt (1:4)",80019-35-8, The LD50 cut-off value of CR SR94 was great than 2000 mg/kg body weight (OECD TG423). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b0594b1-1635-4766-9122-b377a296ec4d/documents/26762948-ff85-41ec-ae2b-9f4fa4bf88eb_c1a60861-6841-4bcf-a43f-c7b9c3b96d9c.html,,,,,, "2,7-Naphthalenedisulfonic acid, 5-(acetylamino)-3-[2-[5-[[4-chloro-6-[[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-sulfophenyl]diazenyl]-4-hydroxy-, sodium salt (1:4)",80019-35-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b0594b1-1635-4766-9122-b377a296ec4d/documents/26762948-ff85-41ec-ae2b-9f4fa4bf88eb_c1a60861-6841-4bcf-a43f-c7b9c3b96d9c.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "2,9,11,13,15,22,24,26,27,28- decaazatricyclo[21.3.1.1^(10,14)]octacosa- 1(27),10,12,14(28),23,25-hexaene-12,25-diamine, N,N'-bis(1,1,3,3-tetramethylbutyl)-2,9,15,22-tetrakis(2,2,6,6-tetramethyl-4-piperidinyl)-",86168-95-8,"In a subacute study accoding to OECD TG 407 and GLP with rats (Ciba-Geigy, 1986) the test substance did not cause any adverse effects up to the highest dose tested (1000 mg/kg), therefore, the NOAEL was set at 1000 mg/kg bw. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3856ff5-3e85-4519-98b6-684580f81fe5/documents/4717aaf0-25be-4581-a690-2bb71ffaed6f_8cac3497-3a3f-43ee-9390-1211fbdb5acd.html,,,,,, "2,9,11,13,15,22,24,26,27,28- decaazatricyclo[21.3.1.1^(10,14)]octacosa- 1(27),10,12,14(28),23,25-hexaene-12,25-diamine, N,N'-bis(1,1,3,3-tetramethylbutyl)-2,9,15,22-tetrakis(2,2,6,6-tetramethyl-4-piperidinyl)-",86168-95-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3856ff5-3e85-4519-98b6-684580f81fe5/documents/4717aaf0-25be-4581-a690-2bb71ffaed6f_8cac3497-3a3f-43ee-9390-1211fbdb5acd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,9,11,13,15,22,24,26,27,28- decaazatricyclo[21.3.1.1^(10,14)]octacosa- 1(27),10,12,14(28),23,25-hexaene-12,25-diamine, N,N'-bis(1,1,3,3-tetramethylbutyl)-2,9,15,22-tetrakis(2,2,6,6-tetramethyl-4-piperidinyl)-",86168-95-8,"Acute oral toxicity (OECD guideline 401): LD50 > 5000 mg/kg bw (CIBA-GEIGY Ltd., 850040, 1985)Acute dermal toxicity (OECD guideline 402): LD50 > 2000 mg/kg bw (CIBA-GEIGY Ltd., 850043, 1985) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3856ff5-3e85-4519-98b6-684580f81fe5/documents/f9e9c261-2369-4cf1-aff1-4aed1ea533ef_8cac3497-3a3f-43ee-9390-1211fbdb5acd.html,,,,,, "2,9,11,13,15,22,24,26,27,28- decaazatricyclo[21.3.1.1^(10,14)]octacosa- 1(27),10,12,14(28),23,25-hexaene-12,25-diamine, N,N'-bis(1,1,3,3-tetramethylbutyl)-2,9,15,22-tetrakis(2,2,6,6-tetramethyl-4-piperidinyl)-",86168-95-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3856ff5-3e85-4519-98b6-684580f81fe5/documents/f9e9c261-2369-4cf1-aff1-4aed1ea533ef_8cac3497-3a3f-43ee-9390-1211fbdb5acd.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "2,9,11,13,15,22,24,26,27,28- decaazatricyclo[21.3.1.1^(10,14)]octacosa- 1(27),10,12,14(28),23,25-hexaene-12,25-diamine, N,N'-bis(1,1,3,3-tetramethylbutyl)-2,9,15,22-tetrakis(2,2,6,6-tetramethyl-4-piperidinyl)-",86168-95-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3856ff5-3e85-4519-98b6-684580f81fe5/documents/f9e9c261-2369-4cf1-aff1-4aed1ea533ef_8cac3497-3a3f-43ee-9390-1211fbdb5acd.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,9,16,23-tetrakis(2,5-di-tert-butyl-4-methoxyphenoxy)phthalocyanine",2126827-44-7," In an acute oral toxicity study, the substance was administered to female Wistar Han rats in a single dose by oral gavage at 300 (3 animals) and 2000 (6 animals) mg/kg body weight. All animals survived in the highest dose group of 2000 mg/kg body weight. The substance did not cause death or evident signs of toxicity. During the observation period of 15 days, no other signs of intoxication, change of health, nor any other adverse reactions were seen. Macroscopic examination of the animals at the end of the study did not reveal treatment-related changes. The LD50 of the substance is considered to be greater than 2000 mg/kg bw after single oral administration to female rats. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f9a4284-c647-4394-aef0-9b09488f2ed1/documents/a422072b-a85b-43f1-b90d-d0f44223191f_5022adde-0e9b-478d-872e-22a50736f91c.html,,,,,, "2,9,16,23-tetrakis(2,5-di-tert-butyl-4-methoxyphenoxy)phthalocyanine",2126827-44-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f9a4284-c647-4394-aef0-9b09488f2ed1/documents/a422072b-a85b-43f1-b90d-d0f44223191f_5022adde-0e9b-478d-872e-22a50736f91c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,9-bis(2-phenylethyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",67075-37-0,"Oral: NOAEL (28d) >= 1501 mg/kg bw/d, rat, according to OECD 407, GLP ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78cb9b2b-b142-4855-b0e2-4f8a6ef9ac46/documents/IUC5-e3641601-467f-46d0-841c-e157969dd848_ffe85be2-488f-45e1-b5dc-ad53c318187a.html,,,,,, "2,9-bis(2-phenylethyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",67075-37-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78cb9b2b-b142-4855-b0e2-4f8a6ef9ac46/documents/IUC5-e3641601-467f-46d0-841c-e157969dd848_ffe85be2-488f-45e1-b5dc-ad53c318187a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,501 mg/kg bw/day",,rat "2,9-bis(2-phenylethyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",67075-37-0,"Oral: LD50 (m/f) > 5000 mg/kg bw, rat, similar to OECD TG 401, no GLP Inhalation: Read-across, LC50 (m/f) > 5.2 mg/L air, rat, according to OECD TG 403, no GLP ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78cb9b2b-b142-4855-b0e2-4f8a6ef9ac46/documents/IUC5-9fbf614a-070d-404e-aeee-57dd0c4716e6_ffe85be2-488f-45e1-b5dc-ad53c318187a.html,,,,,, "2,9-bis(2-phenylethyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",67075-37-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78cb9b2b-b142-4855-b0e2-4f8a6ef9ac46/documents/IUC5-9fbf614a-070d-404e-aeee-57dd0c4716e6_ffe85be2-488f-45e1-b5dc-ad53c318187a.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2,9-bis(2-phenylethyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",67075-37-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78cb9b2b-b142-4855-b0e2-4f8a6ef9ac46/documents/IUC5-9fbf614a-070d-404e-aeee-57dd0c4716e6_ffe85be2-488f-45e1-b5dc-ad53c318187a.html,,inhalation,discriminating conc.,"5,200 mg/m3",no adverse effect observed, "2,9-bis(3,5-dimethylphenyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",4948-15-6,"Oral: Read-across, NOAEL (28d) >= 1000 mg/kg bw/d, rat, according to OECD 407, GLP Inhalation: Read-across, NOAEC systemic (90d) = 20 mg/m³ air, NOAEC local (90d) = 1 mg/m³ air, rat, according OECD to 413, GLP ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d89f468-fd3e-461f-b96d-778f33589b4c/documents/IUC5-d2fac8dc-5362-41bf-bcbe-ec04dff81efc_bc9baae4-6701-401c-aaeb-bd391c8c5d90.html,,,,,, "2,9-bis(3,5-dimethylphenyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",4948-15-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d89f468-fd3e-461f-b96d-778f33589b4c/documents/IUC5-d2fac8dc-5362-41bf-bcbe-ec04dff81efc_bc9baae4-6701-401c-aaeb-bd391c8c5d90.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,9-bis(3,5-dimethylphenyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",4948-15-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d89f468-fd3e-461f-b96d-778f33589b4c/documents/IUC5-d2fac8dc-5362-41bf-bcbe-ec04dff81efc_bc9baae4-6701-401c-aaeb-bd391c8c5d90.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,20 mg/m3,,rat "2,9-bis(3,5-dimethylphenyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",4948-15-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d89f468-fd3e-461f-b96d-778f33589b4c/documents/IUC5-d2fac8dc-5362-41bf-bcbe-ec04dff81efc_bc9baae4-6701-401c-aaeb-bd391c8c5d90.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1 mg/m3,adverse effect observed,rat "2,9-bis(3,5-dimethylphenyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",4948-15-6,"Oral: LD50 (m/f) > 5000 mg/kg bw, rat, similar to OECD TG 401, no GLP Inhalation: LC50 (m/f) > 5.2 mg/L air, rat, according to OECD TG 403, no GLP ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d89f468-fd3e-461f-b96d-778f33589b4c/documents/IUC5-48963d82-091d-4262-828c-affa782af9b3_bc9baae4-6701-401c-aaeb-bd391c8c5d90.html,,,,,, "2,9-bis(3,5-dimethylphenyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",4948-15-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d89f468-fd3e-461f-b96d-778f33589b4c/documents/IUC5-48963d82-091d-4262-828c-affa782af9b3_bc9baae4-6701-401c-aaeb-bd391c8c5d90.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2,9-bis(3,5-dimethylphenyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",4948-15-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d89f468-fd3e-461f-b96d-778f33589b4c/documents/IUC5-48963d82-091d-4262-828c-affa782af9b3_bc9baae4-6701-401c-aaeb-bd391c8c5d90.html,,inhalation,discriminating conc.,"5,200 mg/m3",no adverse effect observed, "2,9-bis(p-methoxybenzyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",83524-75-8,"Oral: Read-across, NOAEL (90d) >= 1133 mg/kg bw/d, rat, equivalent to OECD 408, no GLP ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6057285-d7d0-4a28-8739-33810bcd4ded/documents/IUC5-de0b435a-4baf-4216-88bc-86a664804586_409997dc-74e4-4d03-8722-49f597736340.html,,,,,, "2,9-bis(p-methoxybenzyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",83524-75-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6057285-d7d0-4a28-8739-33810bcd4ded/documents/IUC5-de0b435a-4baf-4216-88bc-86a664804586_409997dc-74e4-4d03-8722-49f597736340.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,133 mg/kg bw/day",,rat "2,9-bis(p-methoxybenzyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",83524-75-8,"Oral: LD50 (m/f) > 5000 mg/kg bw, rat, similar to OECD TG 401, no GLP Inhalation: LC50 (m/f) > 5.4 mg/L air, rat, similar to OECD TG 403, no GLP ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6057285-d7d0-4a28-8739-33810bcd4ded/documents/IUC5-f22f5306-eac8-4724-a61e-86cb2d54c20b_409997dc-74e4-4d03-8722-49f597736340.html,,,,,, "2,9-bis(p-methoxybenzyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",83524-75-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6057285-d7d0-4a28-8739-33810bcd4ded/documents/IUC5-f22f5306-eac8-4724-a61e-86cb2d54c20b_409997dc-74e4-4d03-8722-49f597736340.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2,9-bis(p-methoxybenzyl)anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",83524-75-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6057285-d7d0-4a28-8739-33810bcd4ded/documents/IUC5-f22f5306-eac8-4724-a61e-86cb2d54c20b_409997dc-74e4-4d03-8722-49f597736340.html,,inhalation,discriminating conc.,"5,400 mg/m3",no adverse effect observed, "2,9-bis[4-(phenylazo)phenyl]anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",3049-71-6,"Oral: Read-across, NOAEL (28d) >= 1000 mg/kg bw/d, rat, according to OECD 407, GLP Inhalation: NOAEC systemic (90d) = 20 mg/m³ air, NOAEC local (90d) = 1 mg/m³ air, rat, according to OECD 413, GLP ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d9f4ca0b-50b5-4da1-aefd-1adf349ed8ad/documents/IUC5-70f97254-52d3-4ba4-b9b4-7f0feebbe6dc_49114e41-977d-4e65-9478-f75395b76898.html,,,,,, "2,9-bis[4-(phenylazo)phenyl]anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",3049-71-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d9f4ca0b-50b5-4da1-aefd-1adf349ed8ad/documents/IUC5-70f97254-52d3-4ba4-b9b4-7f0feebbe6dc_49114e41-977d-4e65-9478-f75395b76898.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,9-bis[4-(phenylazo)phenyl]anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",3049-71-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d9f4ca0b-50b5-4da1-aefd-1adf349ed8ad/documents/IUC5-70f97254-52d3-4ba4-b9b4-7f0feebbe6dc_49114e41-977d-4e65-9478-f75395b76898.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,20 mg/m3,,rat "2,9-bis[4-(phenylazo)phenyl]anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",3049-71-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d9f4ca0b-50b5-4da1-aefd-1adf349ed8ad/documents/IUC5-70f97254-52d3-4ba4-b9b4-7f0feebbe6dc_49114e41-977d-4e65-9478-f75395b76898.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1 mg/m3,adverse effect observed,rat "2,9-bis[4-(phenylazo)phenyl]anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",3049-71-6,"Oral: LD50 (m/f) > 5000 mg/kg bw, rat, according to OECD TG 401, no GLP Inhalation: Read-across, LC50 (m/f) > 5.2 mg/L air, rat, similar to OECD TG 403, no GLP ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9f4ca0b-50b5-4da1-aefd-1adf349ed8ad/documents/8d1fb775-7937-4b4c-ac06-f57d4c0e8534_49114e41-977d-4e65-9478-f75395b76898.html,,,,,, "2,9-bis[4-(phenylazo)phenyl]anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",3049-71-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9f4ca0b-50b5-4da1-aefd-1adf349ed8ad/documents/8d1fb775-7937-4b4c-ac06-f57d4c0e8534_49114e41-977d-4e65-9478-f75395b76898.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2,9-bis[4-(phenylazo)phenyl]anthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",3049-71-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9f4ca0b-50b5-4da1-aefd-1adf349ed8ad/documents/8d1fb775-7937-4b4c-ac06-f57d4c0e8534_49114e41-977d-4e65-9478-f75395b76898.html,,inhalation,discriminating conc.,"5,200 mg/m3",no adverse effect observed, "2,9-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione",3089-17-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): valid and reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): valid and reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49eebe0f-1643-47e3-8507-ea80883c3871/documents/0eedcf33-7db8-42c0-8c24-80d6e2835a9c_2e0598d9-e608-4f44-8e58-b9d3b1754fdf.html,,,,,, "2,9-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione",3089-17-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49eebe0f-1643-47e3-8507-ea80883c3871/documents/0eedcf33-7db8-42c0-8c24-80d6e2835a9c_2e0598d9-e608-4f44-8e58-b9d3b1754fdf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,9-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione",3089-17-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49eebe0f-1643-47e3-8507-ea80883c3871/documents/0eedcf33-7db8-42c0-8c24-80d6e2835a9c_2e0598d9-e608-4f44-8e58-b9d3b1754fdf.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,100 mg/m3,,rat "2,9-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione",3089-17-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49eebe0f-1643-47e3-8507-ea80883c3871/documents/0eedcf33-7db8-42c0-8c24-80d6e2835a9c_2e0598d9-e608-4f44-8e58-b9d3b1754fdf.html,Repeated dose toxicity – local effects,inhalation,NOAEC,100 mg/m3,adverse effect observed,rat "2,9-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione",3089-17-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): reliable ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49eebe0f-1643-47e3-8507-ea80883c3871/documents/e1898306-1095-46dd-bfe8-b779d1eaf06b_2e0598d9-e608-4f44-8e58-b9d3b1754fdf.html,,,,,, "2,9-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione",3089-17-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49eebe0f-1643-47e3-8507-ea80883c3871/documents/e1898306-1095-46dd-bfe8-b779d1eaf06b_2e0598d9-e608-4f44-8e58-b9d3b1754fdf.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,9-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione",3089-17-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49eebe0f-1643-47e3-8507-ea80883c3871/documents/e1898306-1095-46dd-bfe8-b779d1eaf06b_2e0598d9-e608-4f44-8e58-b9d3b1754fdf.html,,inhalation,LC0,3.055 mg/L,no adverse effect observed, "2,9-dimethylanthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",5521-31-3,"Oral: Read-across, NOAEL (28d) >= 1000 mg/kg bw/d, rat, according to OECD 407, GLP Inhalation: Read-across, NOAEC systemic (90d) = 20 mg/m³ air, NOAEC local (90d) = 1 mg/m³ air, rat, according to OECD 413, GLP ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e340b8e-1cff-41f9-870e-eb2ce37f0829/documents/IUC5-e6ab996a-28b0-458f-b1d3-579e4c06d86c_2377c851-058f-46ca-a63c-b99e39c41d1e.html,,,,,, "2,9-dimethylanthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",5521-31-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e340b8e-1cff-41f9-870e-eb2ce37f0829/documents/IUC5-e6ab996a-28b0-458f-b1d3-579e4c06d86c_2377c851-058f-46ca-a63c-b99e39c41d1e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,9-dimethylanthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",5521-31-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e340b8e-1cff-41f9-870e-eb2ce37f0829/documents/IUC5-e6ab996a-28b0-458f-b1d3-579e4c06d86c_2377c851-058f-46ca-a63c-b99e39c41d1e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,20 mg/m3,,rat "2,9-dimethylanthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",5521-31-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e340b8e-1cff-41f9-870e-eb2ce37f0829/documents/IUC5-e6ab996a-28b0-458f-b1d3-579e4c06d86c_2377c851-058f-46ca-a63c-b99e39c41d1e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1 mg/m3,adverse effect observed,rat "2,9-dimethylanthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",5521-31-3,"Oral: LD50 (m/f) > 5000 mg/kg bw, rat, according to OECD TG 401, no GLP Inhalation: Read-across, LC50 (m/f) > 5.2 mg/L air, rat, according to OECD TG 403, GLP compliant Dermal: LD50 (m/f) > 2500 mg/kg bw, rat, similar to OECD TG 402, no GLP ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e340b8e-1cff-41f9-870e-eb2ce37f0829/documents/IUC5-35bfc60d-f4f7-4f53-aa3e-a0aea19e01e7_2377c851-058f-46ca-a63c-b99e39c41d1e.html,,,,,, "2,9-dimethylanthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",5521-31-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e340b8e-1cff-41f9-870e-eb2ce37f0829/documents/IUC5-35bfc60d-f4f7-4f53-aa3e-a0aea19e01e7_2377c851-058f-46ca-a63c-b99e39c41d1e.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2,9-dimethylanthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",5521-31-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e340b8e-1cff-41f9-870e-eb2ce37f0829/documents/IUC5-35bfc60d-f4f7-4f53-aa3e-a0aea19e01e7_2377c851-058f-46ca-a63c-b99e39c41d1e.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "2,9-dimethylanthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-1,3,8,10(2H,9H)-tetrone",5521-31-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e340b8e-1cff-41f9-870e-eb2ce37f0829/documents/IUC5-35bfc60d-f4f7-4f53-aa3e-a0aea19e01e7_2377c851-058f-46ca-a63c-b99e39c41d1e.html,,inhalation,discriminating conc.,"5,200 mg/m3",no adverse effect observed, "2-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]ethyl ethyl carbonate",40530-60-7,"Repeated dose oral toxicity: Currently no study investigating potential effects of repeated exposure to Disperse Red 302 is available. However, the source chemical Disperse Red 302:1 (FAT 93504/B) was evaluated for the systemic as well as reproductive toxicity on repeated exposure in a study conducted according to OECD Guideline 422. The systemic toxicity and potential adverse effects of FAT 93504/B on reproduction (including offspring development), to evaluate some endocrine disruptor relevant endpoints, were investigated in a study conducted according to OECD Guideline 422. The test item was administered by gavage to three groups, each of twelve male and twelve female Wistar Han™:RccHan™:WIST strain rats, for approximately six weeks for males and throughout a two week pre-pairing phase, pairing, gestation and lactation to Day 14 for females, at dose levels of 100, 300 and 1000 mg/kg bw/day. A control group of twelve males and twelve females was dosed with vehicle alone (Arachis oil BP) over the same treatment period. There were no unscheduled deaths and no clinical signs observed during the study. No adverse effects of treatment were seen on functional observations. Body weight, food consumption, food conversion efficiency and water consumption were also not affected. No adverse effects were recorded on hematological, clinical biochemistry, pathological, histopathological and organ weight examinations. Evaluation of Thyroxine (T4) in adult males and offspring at Day 13 of age did not identify any obvious effect of treatment or indication of endocrine disruption at 100, 300 or 1000 mg/kg bw/day. Further, no effects on reproductive and developmental parameters were seen. Based on the above findings, the No Observed Adverse Effect Level (NOAEL) for adult toxicity was considered to be 1000 mg/kg bw/day. Using the principles of read-across, Disperse Red 302 is also considered to have a NOAEL for systemic toxicity at 1000 mg/kg bw/day.   Repeated dose inhalation toxicity: Currently no study to assess the repeated dose inhalation toxicity potential of Disperse Red 302 is available. However, the vapour pressure for the substance can be considered low (1.46 x 10-9 Pa), so the potential for the generation of inhalable forms is low. Synthesis and spray drying of this chemical is performed in a closed process; the final product consists of non-dusty granules. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, the study on repeated dose inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected. Referring to the expected low volatility of the substance, the fact that the substance is imported into the EU in a formulated form as liquid formulation, the exposure via inhalation is considered to be unlikely. The chemical showed low toxicity potential in the available acute oral toxicity studies (LD50>2000 mg/kg bw). Further, results from a combined repeated dose toxicity study with reproductive and developmental screening (with the source substance) are available for consideration. No more adverse effects in addition to the ones observed via the oral route are expected via the inhalation route and safety for human health can be estimated via route to route extrapolation. Taking above arguments into account, low toxicity potential is expected on repeated exposure of Disperse Red 302 via inhalation route and hence, testing by the inhalation route was considered scientifically not necessary.   Repeated dose dermal toxicity: Currently no study to assess the repeated dose dermal toxicity of Disperse Red 302 is available. However, the water solubility of Disperse Red 302 was found to be low (0.224 µg/L), this indicates that the partition of the substance from stratum corneum into the epidermis will be low, thereby further limiting the absorption if any dermal exposure occurs. Synthesis and spray drying of this chemical is performed in a closed process without isolation of reaction products. Isolated products consist of either liquid formulations or dust free granules (non-dusty solid). In addition, the use of this substance will not result in aerosols, particles or droplets, so exposure to humans via the dermal route will be unlikely to occur. The chemical showed low toxicity potential in the available acute oral toxicity studies (LD50>2000 mg/kg bw). Further, results from a combined repeated dose toxicity study with reproductive and developmental screening (with the source substance) are available for consideration. No more adverse effects in addition to the ones observed via the oral route are expected via the inhalation route and safety for human health can be estimated via route to route extrapolation. Similarly, absence of systemic toxicity in sensitization studies, further supports the conclusion that low toxicity is expected for the chemical via the dermal route. Taking the above arguments into account, low toxicity potential is expected on repeated exposure of Disperse Red 302 via dermal route and hence, repeated dose toxicity testing by the dermal route was considered scientifically not necessary. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): High quality GLP study. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac3ca9dd-191d-4327-9322-7387f71e96e6/documents/3f5664ff-f299-4e81-b3a2-654e2c7fb1b0_90137dde-6207-48f5-ac7e-06c1597d9ae2.html,,,,,, "2-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]ethyl ethyl carbonate",40530-60-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac3ca9dd-191d-4327-9322-7387f71e96e6/documents/3f5664ff-f299-4e81-b3a2-654e2c7fb1b0_90137dde-6207-48f5-ac7e-06c1597d9ae2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]ethyl ethyl carbonate",40530-60-7," Acute toxicity: oral Acute oral toxicity of FAT 93503/A was evaluated when administered by single oral gavage to Wistar rats, followed by an observation period of 14 days. This study was performed according to the OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method). Two groups, each using three male or three female Hanlbm: WIST (SPF) rats were treated with FAT 93503/A at 2000 mg/kg by oral gavage, in a stepwise manner. No deaths occurred during the study. No clinical signs were observed in all males during the observation period. One female animal was observed with ruffled fur, hunched posture and tremor from 1 to 5 hours after the administration. Two female animals showed a marked loss of body weight (24.5 % and 23 %) one week after treatment. The body weight of the other animals was within the range commonly recorded for animals of this strain and age. No macroscopic findings were observed at necropsy. Based on the findings of the study, the median lethal dose of FAT 93503/A after single oral administration to rats of both sexes, observed over a period of 14 days was found to be >2000 mg/kg bw. Acute toxicity: inhalation Currently no study to assess the acute inhalation toxicity potential of Disperse Red 302 is available. However, the vapour pressure for the substance can be considered low (1.46 x 10-9 Pa). Hence, the substance is considered to have low volatility. Synthesis and spray drying of this chemical is performed in a closed process; the final product consists of non-dusty granules. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets. Referring to the expected low volatility of the substance, the fact that the substance is imported into the EU in a formulated form as liquid formulation, the exposure via inhalation is considered to be unlikely. The chemical showed low toxicity potential in the available acute oral toxicity studies (LD50>2000 mg/kg bw) with no mortality or systemic toxicity, hence it does not need to be classified STOT SE. Taking the above arguments into account, low toxicity potential is expected on acute exposure of Disperse Red 302 via inhalation route and hence testing by the inhalation route was considered scientifically not necessary. Acute toxicity: dermal Currently no study to assess the acute dermal toxicity of Disperse Red 302 is available. However, the substance has very low solubility in water (0.224 µg/L), hence dermal uptake is likely to be low as the substance is considered as not sufficiently soluble in water to partition from the Stratum corneum into the epidermis, indicating limited dermal absorption.Synthesis and spray drying of this chemical is performed in a closed process;without isolation of reaction products. Isolated products consist of either liquid formulations or dust free granules (non-dusty solid). In addition, the use of this substance will not result in aerosols, particles or droplets, so exposure to humans via the dermal route will be unlikely to occur. The chemical showed low toxicity potential in the available acute oral toxicity studies (LD50>2000 mg/kg bw) with no mortality or systemic toxicity, hence it does not need to be classified STOT SE. Similarly, absence of local toxicity in skin and eye irritation as well as sensitization studies further supports the conclusion that low toxicity is expected for the chemical via the dermal route. Taking above arguments into account, low toxicity potential is expected on acute exposure of Disperse Red 302 via dermal route and hence acute toxicity testing by the dermal route was considered scientifically not necessary. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac3ca9dd-191d-4327-9322-7387f71e96e6/documents/IUC5-ade3f97f-9901-4641-b67b-b1cf2dd26057_90137dde-6207-48f5-ac7e-06c1597d9ae2.html,,,,,, "2-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]ethyl ethyl carbonate",40530-60-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac3ca9dd-191d-4327-9322-7387f71e96e6/documents/IUC5-ade3f97f-9901-4641-b67b-b1cf2dd26057_90137dde-6207-48f5-ac7e-06c1597d9ae2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]ethyl phenyl carbonate",28173-59-3, No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be 1000 mg/kg bw/day. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7aaab3d-cd4e-4c84-88aa-3b16669e65b4/documents/eaba4694-4ae0-4381-92a2-eb4b2228a81a_ba9a0614-de8f-46f6-a0f9-4339ec5e6794.html,,,,,, "2-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]ethyl phenyl carbonate",28173-59-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7aaab3d-cd4e-4c84-88aa-3b16669e65b4/documents/eaba4694-4ae0-4381-92a2-eb4b2228a81a_ba9a0614-de8f-46f6-a0f9-4339ec5e6794.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]ethyl phenyl carbonate",28173-59-3,"The median lethal dose of FAT 93504/A after single oral administration to rats of both sexes, observed over a period of 14 days was determined to be >2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7aaab3d-cd4e-4c84-88aa-3b16669e65b4/documents/IUC5-605ab2e5-0657-4288-a31e-00fe14ab2a85_ba9a0614-de8f-46f6-a0f9-4339ec5e6794.html,,,,,, "2-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]ethyl phenyl carbonate",28173-59-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7aaab3d-cd4e-4c84-88aa-3b16669e65b4/documents/IUC5-605ab2e5-0657-4288-a31e-00fe14ab2a85_ba9a0614-de8f-46f6-a0f9-4339ec5e6794.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-[(1-methylpropyl)amino]ethanol,35265-04-4,Sec-Butyl aminoethanol is irritating for the nasal passages after a subacute inhalation exposure. No other target organs were identified in repeated dose toxicity studies either by inhalation or oral routes. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7531deb3-a51e-4eeb-a278-ae06a913a7e0/documents/IUC5-0e8ce937-907e-45fa-bc9c-e32dae2a272f_21d86d23-f082-4d33-95da-cc1956ee981d.html,,,,,, 2-[(1-methylpropyl)amino]ethanol,35265-04-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7531deb3-a51e-4eeb-a278-ae06a913a7e0/documents/IUC5-0e8ce937-907e-45fa-bc9c-e32dae2a272f_21d86d23-f082-4d33-95da-cc1956ee981d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 2-[(1-methylpropyl)amino]ethanol,35265-04-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7531deb3-a51e-4eeb-a278-ae06a913a7e0/documents/IUC5-0e8ce937-907e-45fa-bc9c-e32dae2a272f_21d86d23-f082-4d33-95da-cc1956ee981d.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,90 mg/m3,,rat 2-[(1-methylpropyl)amino]ethanol,35265-04-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7531deb3-a51e-4eeb-a278-ae06a913a7e0/documents/IUC5-0e8ce937-907e-45fa-bc9c-e32dae2a272f_21d86d23-f082-4d33-95da-cc1956ee981d.html,Repeated dose toxicity – local effects,inhalation,NOAEC,21 mg/m3,adverse effect observed,rat 2-[(1-methylpropyl)amino]ethanol,35265-04-4,The oral LD50 of 2-[(1-methylpropyl)amino]ethanol was comprised between 300 and 2000 mg/kg in rats and its 4-hour exposure LC50 in rats is assumed to be close to the saturated vapor concentration of 0.76 mg/L air. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7531deb3-a51e-4eeb-a278-ae06a913a7e0/documents/IUC5-f8fb1c8e-17a1-4138-a285-15974dbbd1ae_21d86d23-f082-4d33-95da-cc1956ee981d.html,,,,,, 2-[(1-methylpropyl)amino]ethanol,35265-04-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7531deb3-a51e-4eeb-a278-ae06a913a7e0/documents/IUC5-f8fb1c8e-17a1-4138-a285-15974dbbd1ae_21d86d23-f082-4d33-95da-cc1956ee981d.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, 2-[(1-methylpropyl)amino]ethanol,35265-04-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7531deb3-a51e-4eeb-a278-ae06a913a7e0/documents/IUC5-f8fb1c8e-17a1-4138-a285-15974dbbd1ae_21d86d23-f082-4d33-95da-cc1956ee981d.html,,inhalation,LC50,760 mg/m3,adverse effect observed, 2-[(2-cyanoethyl)[4-[(6-nitrobenzothiazol-2-yl)azo]phenyl]amino]ethyl acetate,68133-69-7, Acute toxicity in rats LD50 > 5000 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d521b493-3c2e-4e4b-aa65-463085bfdeb1/documents/51e904de-5ab2-4a3a-a556-c42a768b77be_917f8c7c-8204-4411-974b-e8a736f09bfa.html,,,,,, 2-[(2-ethylhexyl)oxy]ethanol,1559-35-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55f4cc8d-0d82-4552-9bd5-0cbd235ac099/documents/afd8574f-15c1-4a21-8a0d-ad592f9e1973_ef37055e-ae3e-45cb-b18e-ffcb03f36da5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat 2-[(2-ethylhexyl)oxy]ethanol,1559-35-9, The acute oral LD50 was > 4.6 g/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55f4cc8d-0d82-4552-9bd5-0cbd235ac099/documents/bac8e59a-2006-4484-ba0f-f7e7b9aa283b_ef37055e-ae3e-45cb-b18e-ffcb03f36da5.html,,,,,, 2-[(2-ethylhexyl)oxy]ethanol,1559-35-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55f4cc8d-0d82-4552-9bd5-0cbd235ac099/documents/bac8e59a-2006-4484-ba0f-f7e7b9aa283b_ef37055e-ae3e-45cb-b18e-ffcb03f36da5.html,,oral,LD50,"4,600 mg/kg bw",no adverse effect observed, 2-[(2-ethylhexyl)oxy]ethanol,1559-35-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55f4cc8d-0d82-4552-9bd5-0cbd235ac099/documents/bac8e59a-2006-4484-ba0f-f7e7b9aa283b_ef37055e-ae3e-45cb-b18e-ffcb03f36da5.html,,dermal,LD50,"20,000 mg/kg bw",no adverse effect observed, 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide,6358-31-2,"Repeated oral toxicity: An OECD test guideline and GLP-compliant 90-day toxicity study was performed with test item (Pigment Yellow 74) in F344 rats. Groups of 10 male and 10 female rats received 0, 50, 200 and 1000 mg/kg/day by oral gavage in corn oil for 90 days, extra 6 animals/sex in the control and high dose groups were allowed 4 weeks of recovery. The test substance caused elevated liver weights in the high dosed females. As there were no corresponding histopathological or clinical-biochemical alterations found, the most likely interpretation is an adaptive response by enzyme induction. No parallel trend was present in the males. The effects did not persist until the end of the recovery period. No toxicologically significant changes were noted in any of the other parameters investigated in this study (i.e. viability, clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). The No-observed-adverse-effect level (NOAEL) of test item (Pigment Yellow 74) was 1000 mg/kg bw/day in both sexes. This study is supported by an older, pre-guideline study in which male and female rats were administered 500 mg/kg bw of other test item (Pigment Yellow 74) on 14 days during a study period of 18 days. No effects on a limited number of parameters including body weight, urinalysis, hematology, gross macroscopic and microscopic examination were observed. Repeated dermal toxicity: The dermal route was waived; substance is not classified for this endpoint. The substance is considered not to exert any local or systemic adverse effects. Repeated inhalation toxicity: A 28 day inhalation study is ongoing. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/71b15999-b01e-4bc2-8dab-37c341bdc4ae/documents/c3994c7e-6098-4fad-acb1-ddb5686d889e_3e88698f-ba12-43b2-85d4-f33104139b00.html,,,,,, 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide,6358-31-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/71b15999-b01e-4bc2-8dab-37c341bdc4ae/documents/c3994c7e-6098-4fad-acb1-ddb5686d889e_3e88698f-ba12-43b2-85d4-f33104139b00.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide,6358-31-2,"Acute oral toxicity:Acute toxicity after single oral application was tested in male and female rats, which received 2000 mg/kg bw (OECD and GLP guideline compliant study) or 10,000 mg/kg bw or 15,000 mg/kg bw (pre-guideline studies). No animals in these studies died. Acute dermal toxicity:A close analogue of the substance did not exert any local or systemic adverse effects.Acute inhalation toxicity: Study was waived; substance is not classified for this endpoint. When aerosolized in respirable form, the substance is considered likely to behave like an inert dust. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71b15999-b01e-4bc2-8dab-37c341bdc4ae/documents/2d10b9f5-0bdd-4c81-b458-6947ced84c68_3e88698f-ba12-43b2-85d4-f33104139b00.html,,,,,, 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide,6358-31-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71b15999-b01e-4bc2-8dab-37c341bdc4ae/documents/2d10b9f5-0bdd-4c81-b458-6947ced84c68_3e88698f-ba12-43b2-85d4-f33104139b00.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-[(2-methoxy-4-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide,6358-31-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71b15999-b01e-4bc2-8dab-37c341bdc4ae/documents/2d10b9f5-0bdd-4c81-b458-6947ced84c68_3e88698f-ba12-43b2-85d4-f33104139b00.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-[(2-methyl-1-oxoallyl)oxy]ethyl hydrogen 3-chloro-2-hydroxypropylphthalate,54380-33-5, The acute oral toxicity of the test item was determined in accordance with OECD TG 423. The LD50 is female rats was 500 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66e163ad-8552-4762-92dd-c4275f8546d6/documents/53d4bce2-d614-4f0f-9670-ce65a3085b91_1a7344f4-7863-4d80-9b14-6cf12cd14a39.html,,,,,, 2-[(2-methyl-1-oxoallyl)oxy]ethyl hydrogen 3-chloro-2-hydroxypropylphthalate,54380-33-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66e163ad-8552-4762-92dd-c4275f8546d6/documents/53d4bce2-d614-4f0f-9670-ce65a3085b91_1a7344f4-7863-4d80-9b14-6cf12cd14a39.html,,oral,LD50,500 mg/kg bw,adverse effect observed, 2-[(3-aminopropyl)methylamino]ethanol,41999-70-6," Repeated dose toxicity - oral: A key K1 study in male and female Wistar rats in a combined repeated dose toxicity test with reproductive/developmental screening was conducted according to OECD guideline 422 (Griffiths, 2017). The NOAEL is established to be 450 mg/kg body weight/day.  Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure.  Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fba56b14-f7b4-4a10-b37c-ae3117ef8bf1/documents/78f6ee4e-ef4b-4abd-90d3-eacf5b5386ea_419e6368-f660-4b6d-bea4-df633aff4a1d.html,,,,,, 2-[(3-aminopropyl)methylamino]ethanol,41999-70-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fba56b14-f7b4-4a10-b37c-ae3117ef8bf1/documents/78f6ee4e-ef4b-4abd-90d3-eacf5b5386ea_419e6368-f660-4b6d-bea4-df633aff4a1d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat 2-[(3-aminopropyl)methylamino]ethanol,41999-70-6," Acute toxicity: Oral In an acute oral toxicity study in female (RccHan™: WIST) rats, following the fixed dose procedure in accordance with the OECD Guideline 420 and EU Method B.1 bis, the LD50 was established to be in the range of 300 - 2000 mg/kg. Acute toxicity: Inhalation No reliable acute toxicity study via the inhalation route was available. However, this endpoint is waived as reliable data are available for the oral and dermal exposure routes. Acute toxicity: Dermal In an acute dermal toxicity study in male and female New Zealand White rabbits, following the standard acute method according to OECD Guideline 402, the LD50 was established to be in the range of 1000 - 2000 mg/kg (Lemoncelli A, 2007). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fba56b14-f7b4-4a10-b37c-ae3117ef8bf1/documents/4f25a39f-476b-4754-b7c6-8a5999a15e0a_419e6368-f660-4b6d-bea4-df633aff4a1d.html,,,,,, 2-[(3-aminopropyl)methylamino]ethanol,41999-70-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fba56b14-f7b4-4a10-b37c-ae3117ef8bf1/documents/4f25a39f-476b-4754-b7c6-8a5999a15e0a_419e6368-f660-4b6d-bea4-df633aff4a1d.html,,oral,LD50,300 mg/kg bw,adverse effect observed, 2-[(3-aminopropyl)methylamino]ethanol,41999-70-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fba56b14-f7b4-4a10-b37c-ae3117ef8bf1/documents/4f25a39f-476b-4754-b7c6-8a5999a15e0a_419e6368-f660-4b6d-bea4-df633aff4a1d.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, 2-[(4-amino-3-methoxyphenyl)sulphonyl]ethyl hydrogen sulphate,26672-22-0," Acute oral toxicity:  Acute oral toxicity dose (LD50) of 2-[(4-amino-3-methoxyphenyl)sulphonyl]ethyl hydrogen sulphate (CAS no: 26672-22-0) was predicted based on OECD QSAR toolbox 3117 mg/kg bw and different studies available on structurally similar read across substances 5-aminonaphthalene-2-sulphonic acid (119-79-9) 14200 mg/kg bw and 2,4-diaminobenzenesulfonic acid (CAS no: 88-63-1) 3480 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-[(4-amino-3-methoxyphenyl)sulphonyl]ethyl hydrogen sulphate can be classified as category V of acute oral toxicity. Acute Inhalation toxicity:  2-[(4-amino-3-methoxyphenyl)sulphonyl]ethyl hydrogen sulphate (CAS no: 26672-22-0) has very low vapor pressure (1.75E-10 Pa at 25° C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e4233e1-5c14-4872-b952-6db6832fc406/documents/f86b34ee-7e50-4253-b296-af87d7b52d2a_1935fe22-4a56-4dc3-8a1b-7888f72661a2.html,,,,,, 2-[(4-amino-3-methoxyphenyl)sulphonyl]ethyl hydrogen sulphate,26672-22-0,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e4233e1-5c14-4872-b952-6db6832fc406/documents/f86b34ee-7e50-4253-b296-af87d7b52d2a_1935fe22-4a56-4dc3-8a1b-7888f72661a2.html,,oral,LD50,"3,117 mg/kg bw",no adverse effect observed, "2-[(4-chloro-2-nitrophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide",12236-62-3,"A study according to OECD Guideline 422 is a valid investigation of the toxicological effects resulting from repeated oral-gavage administration of the test item to rats (according to OECD 422, GLP compliant). The test item was administered in vehicle (highly purified water) at dosages of 0, 100, 300, and 1000 mg/kg body weight/day, animals in control groups received the vehicle only. Test item was administered to male rats for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum. Based on the observed results from a subacute inhalation study on the close structural analogue Pigment Yellow 175, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item was found to be 0.03 mg/L when exposed for 6 hours/day, 5 days/week, for 04 weeks by flow-past nose-only inhalation route to Sprague Dawley rats. The nominal dose of 0.03 mg/L (6 hrs/day, 5 days/week) is the actual exposure concentration in males and females. Under the conditions of this study, no adverse effects were found in males or females up to the highest dose level of 1000 mg/kg bw/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Valid: Guideline study ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/436dbf92-d953-4365-b283-e8b337ad9f2d/documents/9f5cff5a-5d7d-49bf-8537-89bb9f053219_da32a227-ebac-4ed1-8e2a-8946b72c009a.html,,,,,, "2-[(4-chloro-2-nitrophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide",12236-62-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/436dbf92-d953-4365-b283-e8b337ad9f2d/documents/9f5cff5a-5d7d-49bf-8537-89bb9f053219_da32a227-ebac-4ed1-8e2a-8946b72c009a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-[(4-chloro-2-nitrophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide",12236-62-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/436dbf92-d953-4365-b283-e8b337ad9f2d/documents/9f5cff5a-5d7d-49bf-8537-89bb9f053219_da32a227-ebac-4ed1-8e2a-8946b72c009a.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat "2-[(4-chloro-2-nitrophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide",12236-62-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/436dbf92-d953-4365-b283-e8b337ad9f2d/documents/9f5cff5a-5d7d-49bf-8537-89bb9f053219_da32a227-ebac-4ed1-8e2a-8946b72c009a.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat "2-[(4-chloro-2-nitrophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide",12236-62-3," Single application of 15000 mg/kg bw of the test substance did not cause lethality in female Wistar rats during the 14 day observation period, resulting in a LD50 > 15000 mg/kg bw. Exposure of male and female Wistar rats to 1274 mg/m³ test item (i.e. maximum technically feasible concentration) for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 1274 mg/m³. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/436dbf92-d953-4365-b283-e8b337ad9f2d/documents/6c6d4313-371c-49fb-a7cd-aa3378f99312_da32a227-ebac-4ed1-8e2a-8946b72c009a.html,,,,,, "2-[(4-chloro-2-nitrophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide",12236-62-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/436dbf92-d953-4365-b283-e8b337ad9f2d/documents/6c6d4313-371c-49fb-a7cd-aa3378f99312_da32a227-ebac-4ed1-8e2a-8946b72c009a.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "2-[(4-chloro-2-nitrophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide",12236-62-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/436dbf92-d953-4365-b283-e8b337ad9f2d/documents/6c6d4313-371c-49fb-a7cd-aa3378f99312_da32a227-ebac-4ed1-8e2a-8946b72c009a.html,,inhalation,LC50,"1,274 mg/m3",no adverse effect observed, 2-[(4-chloro-2-nitrophenyl)azo]-N-(4-ethoxyphenyl)-3-oxobutyramide,52320-66-8," Acute oral toxicity:  Acute oral toxicity dose (LD50) of 2-[(E)-2-(4-chloro-2-nitrophenyl)diazen-1-yl]-N-(4-ethoxyphenyl)-3-oxobutanamide (CAS no: 52320-66-8) was predicted based on OECD QSAR toolbox 3592 mg/kg bw and different studies available on structurally similar read across substances 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis [N-(2,4-dimethylphenyl)-3-oxobutyramide] (CAS no: 5102-83-0) >5000 mg/kg bw and 2,2'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis(3-oxo-N-phenylbutanamide) (CAS no: 6358-85-6) >10800 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-[(E)-2-(4-chloro-2-nitrophenyl)diazen-1-yl]-N-(4-ethoxyphenyl)-3-oxobutanamide cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  2-[(E)-2-(4-chloro-2-nitrophenyl)diazen-1-yl]-N-(4-ethoxyphenyl)-3-oxobutanamide (CAS no: 52320-66-8) has very low vapour pressure (2.67E-10 Pa at 25°C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for 2-[(E)-2-(4-chloro-2-nitrophenyl)diazen-1-yl]-N-(4-ethoxyphenyl)-3-oxobutanamide (CAS no: 52320-66-8) was predicted based on OECD QSAR toolbox 2504 mg/kg bwand differentstudies available for the structurally similar read across substanceN-(4-chloro-2,5-dimethoxyphenyl)- 2-[[2,5-dimethoxy-4 -[(phenylamino)sulphonyl]phenyl]azo]-3-oxobutyramide (CAS no: 12225-18-2) >3000 mg/kg bw and 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis [N-(2,4-dimethylphenyl)-3-oxobutyramide] (CAS no: 5102-83-0)>3000 mg/kg bw. All these studies concluded that the LD50 value is>2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-[(E)-2-(4-chloro-2-nitrophenyl)diazen-1-yl]-N-(4-ethoxyphenyl)- 3-oxobutanamide cannot be classified for acute dermal toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c12178d-9f14-4076-935f-c23fa14c3989/documents/f631f178-a5a0-4e55-914f-1ddf766d51e5_a436fc59-1071-485f-9c81-7fb1be37c489.html,,,,,, 2-[(4-chloro-2-nitrophenyl)azo]-N-(4-ethoxyphenyl)-3-oxobutyramide,52320-66-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c12178d-9f14-4076-935f-c23fa14c3989/documents/f631f178-a5a0-4e55-914f-1ddf766d51e5_a436fc59-1071-485f-9c81-7fb1be37c489.html,,oral,LD50,"3,592 mg/kg bw",no adverse effect observed, 2-[(4-chloro-2-nitrophenyl)azo]-N-(4-ethoxyphenyl)-3-oxobutyramide,52320-66-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c12178d-9f14-4076-935f-c23fa14c3989/documents/f631f178-a5a0-4e55-914f-1ddf766d51e5_a436fc59-1071-485f-9c81-7fb1be37c489.html,,dermal,LD50,"2,504 mg/kg bw",no adverse effect observed, 2-[(4-methoxy-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide,6528-34-3,"In a subacute repeated oral-gavage study (OECD 422) the test item, the close analogue Pigment Yellow 1, was administered at dosages of 100, 300, and 1000 mg/kg body weight/day. Test item was administered to male rats for 32 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum. Under the conditions of this study, no adverse effects were found in males or females up to the highest dose level of 1000 mg/kg bw/day. Reproduction and development were not affected by the treatment. Mating performance, fertility, duration of gestation, corpora lutea count, implantation rate, post implantation and postnatal loss or litter size were similar in the control and all dose groups. There were no test item-related findings in pups noted during the first litter check, the first 4 days post partum or during the necropsy, pups body weights and body weight gain were not affected by the treatment at any dose level. Based on these results, the NOAEL (No Observed Adverse Effect Level) for general toxicity in males and females and for reproduction/developmental toxicity was considered to be 1000 mg/kg bw/day, the highest dose level used. A subchronic (90-day) toxicity study in Fischer F344 rats was performed with a close analogue (Pigment Yellow 74) of the test item. Groups of 10 male and 10 female rats received 0, 50, 200 and 1000 mg/kg/day by oral gavage in corn oil for 90 days. The study included additional control and high dose groups of 6 males and 6 females each analyzed after a 4-week recovery period. All animals survived until scheduled termination without any toxic signs in life. In haematology, clinical biochemistry and urinalysis some scattered significant differences, altogether without a clear dose response and all only minor in severity, were noted. Post mortem examination including histopathology did not reveal any test substance related toxic alterations. The test substance caused elevated liver weights in the high dosed females. As there were no corresponding histopathological or clinical-biochemical alterations found, the most likely interpretation is an adaptive response by enzyme induction. No parallel trend was present in the males. The effects did not persist until the end of the recovery period. No other test substance-related effect was noted. The No-observed-adverse-effect-level (NOAEL) of the test item was 1000 mg/kg bw/day in both sexes. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable with restrictions due to read across ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0614691e-f0f0-4a0a-a202-ff36a93831f2/documents/733457f7-9b08-411c-b5b3-6b9b8b768dfd_107c071c-df7b-4914-94b1-a3759c12561f.html,,,,,, 2-[(4-methoxy-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide,6528-34-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0614691e-f0f0-4a0a-a202-ff36a93831f2/documents/733457f7-9b08-411c-b5b3-6b9b8b768dfd_107c071c-df7b-4914-94b1-a3759c12561f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-[(4-methoxy-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide,6528-34-3,"A single oral application of the test item to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality. The median lethal dose after a single oral administration to female rats, observed over a period of 14 days:LD50 > 2000 mg/kg body weight   The acute dermal median lethal dose (LD50) of a close structural analogue (Pigment Yellow 1) in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): valid and reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): valid and realiable ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0614691e-f0f0-4a0a-a202-ff36a93831f2/documents/4c061424-35a2-4a7d-b900-64d5d7545164_107c071c-df7b-4914-94b1-a3759c12561f.html,,,,,, 2-[(4-methoxy-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide,6528-34-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0614691e-f0f0-4a0a-a202-ff36a93831f2/documents/4c061424-35a2-4a7d-b900-64d5d7545164_107c071c-df7b-4914-94b1-a3759c12561f.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-[(4-methoxy-2-nitrophenyl)azo]-N-(2-methoxyphenyl)-3-oxobutyramide,6528-34-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0614691e-f0f0-4a0a-a202-ff36a93831f2/documents/4c061424-35a2-4a7d-b900-64d5d7545164_107c071c-df7b-4914-94b1-a3759c12561f.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2-Propenoic acid, 2-[[(octadecylamino)carbonyl]oxy]ethyl ester",78433-08-6, Repeated dose toxicity of the test substance. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08ac6c30-9a04-4b19-acbb-13b5de91eea5/documents/96738f36-09c1-46f6-995d-2e1e08c22262_5ca7cf7a-1c38-4fe9-b14a-41fb4289e2ba.html,,,,,, "2-Propenoic acid, 2-[[(octadecylamino)carbonyl]oxy]ethyl ester",78433-08-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08ac6c30-9a04-4b19-acbb-13b5de91eea5/documents/96738f36-09c1-46f6-995d-2e1e08c22262_5ca7cf7a-1c38-4fe9-b14a-41fb4289e2ba.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-Propenoic acid, 2-[[(octadecylamino)carbonyl]oxy]ethyl ester",78433-08-6," Acute toxicity - oral: In an OECD 420 study, under GLP conditions, the acute toxicity LD50 (oral) of 2-Propenoic acid, 2-[[(octadecylamino)carbonyl]oxy]ethyl ester is 2000 mg/kg (Envigo, 2016d). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08ac6c30-9a04-4b19-acbb-13b5de91eea5/documents/d2a72ac9-e78c-4897-82b3-6dbf4727037a_5ca7cf7a-1c38-4fe9-b14a-41fb4289e2ba.html,,,,,, "2-Propenoic acid, 2-[[(octadecylamino)carbonyl]oxy]ethyl ester",78433-08-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08ac6c30-9a04-4b19-acbb-13b5de91eea5/documents/d2a72ac9-e78c-4897-82b3-6dbf4727037a_5ca7cf7a-1c38-4fe9-b14a-41fb4289e2ba.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Propenoic acid, 2-[[(octadecylamino)carbonyl]oxy]ethyl ester",78433-08-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08ac6c30-9a04-4b19-acbb-13b5de91eea5/documents/d2a72ac9-e78c-4897-82b3-6dbf4727037a_5ca7cf7a-1c38-4fe9-b14a-41fb4289e2ba.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Propenoic acid, 2-[[(octadecylamino)carbonyl]oxy]ethyl ester",78433-08-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08ac6c30-9a04-4b19-acbb-13b5de91eea5/documents/d2a72ac9-e78c-4897-82b3-6dbf4727037a_5ca7cf7a-1c38-4fe9-b14a-41fb4289e2ba.html,,inhalation,LC50,"4,940 mg/m3",no adverse effect observed, 2-[[(2S)-2-(9H-fluoren-9-ylmethoxycarbonylamino)-3-(1H-imidazol-5-yl)propanoyl]amino]-2-methyl-propanoic acid Trifluoroacetic acid salt (1:1),1446013-08-6, The oral LD50 for female rats was estimated to be 5000 mg.Kg-1 of body weight. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2f9d87a-48b9-469f-b950-741e5b235d7d/documents/41279d3d-83ce-4579-bc76-c20b1fd8ca57_6773d0c4-ccae-43ea-a6d1-4b6569c4f909.html,,,,,, 2-[[(2S)-2-(9H-fluoren-9-ylmethoxycarbonylamino)-3-(1H-imidazol-5-yl)propanoyl]amino]-2-methyl-propanoic acid Trifluoroacetic acid salt (1:1),1446013-08-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2f9d87a-48b9-469f-b950-741e5b235d7d/documents/41279d3d-83ce-4579-bc76-c20b1fd8ca57_6773d0c4-ccae-43ea-a6d1-4b6569c4f909.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium acetate",58798-47-3,"The toxicity of the test item, following daily oral administration by gavage for four consecutive weeks and recovery from any treatment related effects during a period of two weeks, was investigated in a study according to OECD 407. The NOAEL of 95 mg/kg bw/day based on the effects on mortality, body weight, food consumption, certain clinical chemistry parameters and organ weights seen in the high dose group. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0625fab-35e4-4b51-9def-d0ec699b42cf/documents/IUC5-46c74089-f8c2-4b21-a3b3-347ec748533b_9f7a23b0-27e2-4481-9b39-d6d1d94ed010.html,,,,,, "2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium acetate",58798-47-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0625fab-35e4-4b51-9def-d0ec699b42cf/documents/IUC5-46c74089-f8c2-4b21-a3b3-347ec748533b_9f7a23b0-27e2-4481-9b39-d6d1d94ed010.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,95 mg/kg bw/day,,rat "2-[[(4-methoxyphenyl)methylhydrazono]methyl]-1,3,3-trimethyl-3H-indolium acetate",58798-47-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0625fab-35e4-4b51-9def-d0ec699b42cf/documents/IUC5-2c8d0174-cc74-4f64-97ba-f60b1d73f0f9_9f7a23b0-27e2-4481-9b39-d6d1d94ed010.html,,oral,LD50,906 mg/kg bw,adverse effect observed, "2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzoic acid",31837-42-0," The results of a subchronic oral repeated dose study study indicated that the oral administration of test item for 90 consecutive days in Wistar rats at dose levels of 111, 333 and 1000 mg/kg/day doses did not cause any toxicological effect on general health, body weights, food consumption, haematology, clinical chemistry, coagulation parameters, terminal fasting body weight, organ weights and histopathology in both sexes. Yellow colour faecal matter was observed at all the tested doses in both sexes during the treatment period. Grossly, yellow colored intestinal contents noted in 333 mg/kg/day and 1000 mg/kg/day rats (both sex). Yellow colour of faecal matter and intestinal contents was attributed to the physical appearance of the test item. As there were no treatment-related adverse effects observed up to the highest dose, the No Observed Adverse Effect Level (NOAEL) for systemic toxicity of the test item is considered to be 1000 mg/kg/day under the test conditions and doses employed. Based on the results observed in a subacute inhalation study, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item was found to be 0.03 mg/L (30 mg/m³) when exposed for 6 hours/day, 5 days/week, for 4 weeks by flow-past nose-only inhalation route to Sprague Dawley rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1725dfa5-78ef-4446-9749-df83164cd3db/documents/776d7d65-545a-46e3-af7a-d4d886879ab0_36293d1e-ce88-4552-9329-e942b0a154be.html,,,,,, "2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzoic acid",31837-42-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1725dfa5-78ef-4446-9749-df83164cd3db/documents/776d7d65-545a-46e3-af7a-d4d886879ab0_36293d1e-ce88-4552-9329-e942b0a154be.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat "2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzoic acid",31837-42-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1725dfa5-78ef-4446-9749-df83164cd3db/documents/776d7d65-545a-46e3-af7a-d4d886879ab0_36293d1e-ce88-4552-9329-e942b0a154be.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzoic acid",31837-42-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1725dfa5-78ef-4446-9749-df83164cd3db/documents/776d7d65-545a-46e3-af7a-d4d886879ab0_36293d1e-ce88-4552-9329-e942b0a154be.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat "2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzoic acid",31837-42-0," Female Wistar rats were subjected to test acute oral toxicity. The test substance was administered by gavage at the highest dose levels applicable: 15000 mg/kg bw. No animal died under these conditions during the 14 -day observation period, thus leading to a LD50 > 15000 mg/kg bw. Acute inhalation toxicity of the test item has been investigated in male and female Wistar rats. Mean dust exposure concentration was 709 mg test substance per cubic metre (i.e. maximum technically feasible concentration; exposure ranged from 544 to 1098 mg/ cubic metre). The rats were exposed for 4 hours. All animals survived the 14 day observation period. No macroscopic visible changes were observed at necropsy at the end of the observation period, resulting in a LC50 value of > 709 mg/m³ for the inhalation of dust. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1725dfa5-78ef-4446-9749-df83164cd3db/documents/4e5d48b1-ee7a-402c-8e6d-e3efcb02fb3f_36293d1e-ce88-4552-9329-e942b0a154be.html,,,,,, "2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzoic acid",31837-42-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1725dfa5-78ef-4446-9749-df83164cd3db/documents/4e5d48b1-ee7a-402c-8e6d-e3efcb02fb3f_36293d1e-ce88-4552-9329-e942b0a154be.html,,oral,LD0,"15,000 mg/kg bw",no adverse effect observed, "2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzoic acid",31837-42-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1725dfa5-78ef-4446-9749-df83164cd3db/documents/4e5d48b1-ee7a-402c-8e6d-e3efcb02fb3f_36293d1e-ce88-4552-9329-e942b0a154be.html,,inhalation,LC0,709 mg/m3,no adverse effect observed, 2-[[2-(dimethylamino)ethyl]methylamino]ethanol,2212-32-0, A screening study (OECD 422) and a 14 -day dose finding toxicity study are available for the submission substance. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8962f92d-8567-4b59-83d0-3427e029ba2d/documents/1d7e8486-495d-48ed-8a9b-21ce79c2e3a9_2e7fce3e-1562-431f-aa54-43bfcd3a7ef7.html,,,,,, 2-[[2-(dimethylamino)ethyl]methylamino]ethanol,2212-32-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8962f92d-8567-4b59-83d0-3427e029ba2d/documents/1d7e8486-495d-48ed-8a9b-21ce79c2e3a9_2e7fce3e-1562-431f-aa54-43bfcd3a7ef7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 2-[[2-(dimethylamino)ethyl]methylamino]ethanol,2212-32-0," An acute oral toxicity study is available; waivers are provided for acute dermal toxicity and acute inhalation toxicity, based on the corrosivity of the substance. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8962f92d-8567-4b59-83d0-3427e029ba2d/documents/671f72ad-8ed9-45e8-b3ef-3819a966ae45_2e7fce3e-1562-431f-aa54-43bfcd3a7ef7.html,,,,,, 2-[[2-(dimethylamino)ethyl]methylamino]ethanol,2212-32-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8962f92d-8567-4b59-83d0-3427e029ba2d/documents/671f72ad-8ed9-45e8-b3ef-3819a966ae45_2e7fce3e-1562-431f-aa54-43bfcd3a7ef7.html,,oral,LD50,"2,570 mg/kg bw",no adverse effect observed, 2-[[3-(dimethylamino)propyl]methylamino]ethanol,82136-26-3,"1) Acute oral toxicity of substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol [equivalent or similar to OECD Guideline 401 (deleted on 17 Dec. 2002)]: - LD50 in female rat: estimated to be 1537 mg/kg bw; - LD50 in male rat: estimated to be 1573 mg/kg bw.   2) Acute dermal toxicity of substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol [equivalent or similar to OECD Guideline 402 (before 9 Oct. 2017)]: - LD50 in male rabbit (abraded skin): estimated to be 1772 mg/kg bw; - LD50 in male rabbit (intact skin): estimated to be 1808 mg/kg bw.   3) Acute inhalation toxicity of substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol: no study available; study does not need to be conducted because the substance is classified as corrosive to the skin.    4) Conclusion All of the available studies indicate that the substance 2-[[3-(dimethylamino)propyl]methylamino]ethanol is moderate acute toxic. Based on the results, the LD50 of the registration substance is considered to be 1537 mg/kg bw via the oral route and 1772 mg/kg bw via the dermal route. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): only 1 study available; older study with limited documentation, but considered sufficient for classification and hazard identification Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): only 1 study available; older study with limited documentation, but considered sufficient for classification and hazard identification ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2a611a0-b467-4cc2-ba21-71103d30484e/documents/eaad0592-3d91-42af-afcc-47bd35b0fbe9_f3d245b0-078b-4f45-83b7-50b7b9e5aaad.html,,,,,, 2-[[3-(dimethylamino)propyl]methylamino]ethanol,82136-26-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2a611a0-b467-4cc2-ba21-71103d30484e/documents/eaad0592-3d91-42af-afcc-47bd35b0fbe9_f3d245b0-078b-4f45-83b7-50b7b9e5aaad.html,,oral,LD50,"1,537 mg/kg bw",adverse effect observed, 2-[[3-(dimethylamino)propyl]methylamino]ethanol,82136-26-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2a611a0-b467-4cc2-ba21-71103d30484e/documents/eaad0592-3d91-42af-afcc-47bd35b0fbe9_f3d245b0-078b-4f45-83b7-50b7b9e5aaad.html,,dermal,LD50,"1,772 mg/kg bw",adverse effect observed, 2-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl](2-cyanoethyl)amino]ethyl acetate,28462-17-1, Oral LD50 (male and female) > 5350 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9c0a1ef-570c-4b77-be7e-d15164555be7/documents/c71cfdf0-82ec-46d9-9dbd-1daf2b15cc0c_e1a042bb-9d6b-4ab0-8d9c-3f514c02e34c.html,,,,,, 2-[[3-acetamido-4-[(2-chloro-4-nitrophenyl)azo]phenyl](2-cyanoethyl)amino]ethyl acetate,28462-17-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9c0a1ef-570c-4b77-be7e-d15164555be7/documents/c71cfdf0-82ec-46d9-9dbd-1daf2b15cc0c_e1a042bb-9d6b-4ab0-8d9c-3f514c02e34c.html,,oral,LD50,"5,350 mg/kg bw",no adverse effect observed, 2-[[4-[(2-cyanoethyl)ethylamino]phenyl]azo]-5-nitrobenzonitrile,16889-10-4, Oral LD50 (male and female) > 5000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70803c06-c29e-4200-9870-ae91ee02f13d/documents/3e2faf94-c093-4741-aade-20784485d3c2_d14bd681-6e9a-44e2-bdee-86d02fa3a911.html,,,,,, 2-[[4-[(2-cyanoethyl)ethylamino]phenyl]azo]-5-nitrobenzonitrile,16889-10-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70803c06-c29e-4200-9870-ae91ee02f13d/documents/3e2faf94-c093-4741-aade-20784485d3c2_d14bd681-6e9a-44e2-bdee-86d02fa3a911.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-[[4-[[4-[(4-amino-9,10-dihydro-9,10-dioxo-3-sulpho-1-anthryl)amino]cyclohexyl]amino]-6-fluoro-1,3,5-triazin-2-yl]amino]benzene-1,4-disulphonic acid, potassium sodium salt",72987-16-7," The acute toxicity (oral) for Reactive Blue 181 was assessed in a weight-of-evidence approach containing three studies (rat, oral, gavage). The following LD50 values were determined: - LD50 (male, female) > 5000 mg/kg bw - LD50 (male) > 5000 mg/kg bw - LD50 (male) > 5000 mg/kg bw; LD50 (female) = 4170 mg/kg bw It can be concluded that Reactive Blue 181 is not acutely toxic via oral exposure. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d35d6d9-55d5-4e40-8cfc-2940305b4cf7/documents/5bc5586f-81dc-40c0-8400-5ec405b02b1c_8c014e67-3d57-4851-8e38-c815100b6827.html,,,,,, "2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt",93941-74-3," Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound 2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1- naphthyl]azo]-6-sulpho-1- naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt (93941-74-3). The study assumed the use of male and female Charles River CR strain rat in chronic study of 90days. No significant alterations were noted at the dose level of 1148.5583mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for compound 2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]- 1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt is considered to be 1148.558mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/b64892ac-3a07-4401-b8ec-3dadb5ba5ff1/documents/6e066118-3c0f-4910-847c-ca30b8a81776_e42ffc2c-f694-41b3-bef8-ec654bdcb33b.html,,,,,, "2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt",93941-74-3,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/b64892ac-3a07-4401-b8ec-3dadb5ba5ff1/documents/6e066118-3c0f-4910-847c-ca30b8a81776_e42ffc2c-f694-41b3-bef8-ec654bdcb33b.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,148.558 mg/kg bw/day",,rat "2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt",93941-74-3," Acute oral toxicity:  Acute oral toxicity dose (LD50) of 2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt (CAS no: 93941-74-3) was predicted based on OECD QSAR toolbox 22107 mg/kg bw and different studies available on structurally similar read across substances Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo)) naphthalene-4,6-disulphonate (CAS No. 2519-30-4) >2000 mg/kg bw and Disodium 5-amino-4-hydroxy-3-(phenylazo) naphthalene-2, 7-disulphonate (CAS No. 3567-66-6) >2000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt (CAS no: 93941-74-3) has very low vapour pressure (1.613E-17 Pa at 25°C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for 2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt (CAS no: 93941-74-3) was predicted based on OECD QSAR toolbox 13739 mg/kg bw and different studies available for the structurally similar read across substances Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate (CAS No. 2519-30-4) >2000 mg/kg bw and Disodium 4-hydroxy-3-[(4-sulfonato-1-naphthyl)diazenyl]naphthalene-1-sulfonate (3567-69-9) >2000 mg/kg bw. All these studies concluded that the LD50 value is>2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt cannot be classified for acute dermal toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b64892ac-3a07-4401-b8ec-3dadb5ba5ff1/documents/6ba9c070-5ff0-4a5b-92f6-f567a6212aa9_e42ffc2c-f694-41b3-bef8-ec654bdcb33b.html,,,,,, "2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt",93941-74-3,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b64892ac-3a07-4401-b8ec-3dadb5ba5ff1/documents/6ba9c070-5ff0-4a5b-92f6-f567a6212aa9_e42ffc2c-f694-41b3-bef8-ec654bdcb33b.html,,oral,LD50,"22,107 mg/kg bw",no adverse effect observed, "2-[[4-[[4-[[6-anilino-1-hydroxy-3-sulpho-2-naphthyl]azo]-1-naphthyl]azo]-6-sulpho-1-naphthyl]azo]benzene-1,4-disulphonic acid, magnesium sodium salt",93941-74-3,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b64892ac-3a07-4401-b8ec-3dadb5ba5ff1/documents/6ba9c070-5ff0-4a5b-92f6-f567a6212aa9_e42ffc2c-f694-41b3-bef8-ec654bdcb33b.html,,dermal,LD50,"13,739 mg/kg bw",no adverse effect observed, 2-[[4-[bis(2-hydroxyethyl)amino]-o-tolyl]azo]-5-nitrobenzonitrile,12236-25-8," Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for 2-({4-[bis(2-hydroxyethyl)amino]-2- methylphenyl} diazenyl) -5-nitrobenzonitrile. The study assumed the use of male and female rats in a 24 months toxicity study. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Level (NOAEL) for 2-({4-[bis(2-hydroxyethyl)amino]-2-methylphenyl}diazenyl)-5-nitrobenzonitrile is predicted to be 782.171447754 mg/Kg bw/day.   Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0388f2e4-9d51-4308-bf1b-fcb6511a6251/documents/df5a0d85-1f2e-4646-9a7c-aa0079c1a5a7_77d56a29-a63f-45a4-a448-5dcc89b6832e.html,,,,,, 2-[[4-[bis(2-hydroxyethyl)amino]-o-tolyl]azo]-5-nitrobenzonitrile,12236-25-8,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0388f2e4-9d51-4308-bf1b-fcb6511a6251/documents/df5a0d85-1f2e-4646-9a7c-aa0079c1a5a7_77d56a29-a63f-45a4-a448-5dcc89b6832e.html,Chronic toxicity – systemic effects,oral,NOAEL,782 mg/kg bw/day,,rat 2-[[4-[bis(2-hydroxyethyl)amino]-o-tolyl]azo]-5-nitrobenzonitrile,12236-25-8," Acute Oral Toxicity:  In Acute oral toxicity, LD50 value was predicted based on OECD QSAR toolbox for target substance 2-({4-[bis(2-hydroxyethyl)amino]-2-methylphenyl}diazenyl)-5-nitrobenzonitrile (12236-25-8) was estimated to be 4055.47mg/kg bw and for different studies available on the structurally similar read across substance 3-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]propiononitrile(40880-51-1) was considered to be 10000mg/kg bw and Disperse Red 17(3179-89-3) was considered to be >2000mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation 2-({4-[bis(2-hydroxyethyl)amino]-2-methylphenyl}diazenyl)-5-nitrobenzonitrile (12236-25-8) can be Not classified for acute oral toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0388f2e4-9d51-4308-bf1b-fcb6511a6251/documents/0ab4c2c2-167c-4d07-ad11-a88b03990d6a_77d56a29-a63f-45a4-a448-5dcc89b6832e.html,,,,,, 2-[[4-[bis(2-hydroxyethyl)amino]-o-tolyl]azo]-5-nitrobenzonitrile,12236-25-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0388f2e4-9d51-4308-bf1b-fcb6511a6251/documents/0ab4c2c2-167c-4d07-ad11-a88b03990d6a_77d56a29-a63f-45a4-a448-5dcc89b6832e.html,,oral,LD50,"4,055.47 mg/kg bw",no adverse effect observed, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium acetate,84051-87-6," Repeated dose toxicity: Oral The No Observed Adverse Effect Level (NOAEL) for the test chemical  using male and female rats is considered to be in a dose range of 968- 1200 mg/Kg/day. Repeated dose toxicity: Inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance of 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl)-6-methoxy-3-methyl-1,3-benzothiazol-3-ium acetate(84051-87-6) which is reported as 7.15E-15 mm Hg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical of 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl)-6-methoxy-3-methyl-1,3-benzothiazol-3-ium acetate is highly unlikely. Therefore this study is considered for waiver. Repeated dose toxicity: Dermal The acute toxicity value for 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl)-6-methoxy-3-methyl-1,3-benzothiazol-3-ium acetate(84051-87-6)  (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl)-6-methoxy-3-methyl-1,3-benzothiazol-3-ium acetate shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 2-({4-[ethyl(2-hydroxyethyl)amino]phenyl}diazenyl)-6-methoxy-3-methyl-1,3-benzothiazol-3-ium acetate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/891e041f-f9ef-442f-a47f-e7a6e560482f/documents/e52623f0-5cc6-4264-a318-a946a155d2d1_8334f451-2f6b-41e8-b868-15fc4d740fcc.html,,,,,, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium acetate,84051-87-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/891e041f-f9ef-442f-a47f-e7a6e560482f/documents/e52623f0-5cc6-4264-a318-a946a155d2d1_8334f451-2f6b-41e8-b868-15fc4d740fcc.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium acetate,84051-87-6," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.   Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 9.54E-13 Pa (7.15E-15 mm Hg). Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/891e041f-f9ef-442f-a47f-e7a6e560482f/documents/9e71b6d7-0ef9-4c84-8d3b-fafb8ac2d58e_8334f451-2f6b-41e8-b868-15fc4d740fcc.html,,,,,, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium acetate,84051-87-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/891e041f-f9ef-442f-a47f-e7a6e560482f/documents/9e71b6d7-0ef9-4c84-8d3b-fafb8ac2d58e_8334f451-2f6b-41e8-b868-15fc4d740fcc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-[[4-[ethyl(2-hydroxyethyl)amino]phenyl]azo]-6-methoxy-3-methylbenzothiazolium acetate,84051-87-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/891e041f-f9ef-442f-a47f-e7a6e560482f/documents/9e71b6d7-0ef9-4c84-8d3b-fafb8ac2d58e_8334f451-2f6b-41e8-b868-15fc4d740fcc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-[[4-chloro-6-[[8-hydroxy-3,6-disulpho-7-[(1-sulpho-2-naphthyl)azo]-1-naphthyl]amino]-1,3,5-triazin-2-yl]amino]-5-sulphobenzoic acid, sodium salt",85098-62-0," Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 423, EU Method B.1 tris) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/975c6453-4711-416b-a19d-c13ffbaa212d/documents/4d1a8de2-d583-4d52-bdca-2fd024afc886_69ccd78d-f4c0-45c3-bfba-f7dd7037ca77.html,,,,,, "2-[[4-chloro-6-[[8-hydroxy-3,6-disulpho-7-[(1-sulpho-2-naphthyl)azo]-1-naphthyl]amino]-1,3,5-triazin-2-yl]amino]-5-sulphobenzoic acid, sodium salt",85098-62-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/975c6453-4711-416b-a19d-c13ffbaa212d/documents/4d1a8de2-d583-4d52-bdca-2fd024afc886_69ccd78d-f4c0-45c3-bfba-f7dd7037ca77.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-[1-(2-fluoro-benzyl)-1H-pyrazolo[3,4-b]pyridin-3-yl]-5-phenylazopyrimidine-4,6-diamine",428854-23-3,"No experimental data on acute toxicity of the test item is available. An in silico and read-across prediction for acute oral toxicity was conducted on March 19, 2024 using four different tools (DEREK, Leadscope, EPA TEST, OECD TB). The test item was predicted to have an acute oral toxicity and shall be classified with Cat. 4. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f0b9d1c-052e-4b40-b9a8-8bafab0cee0b/documents/241f89f0-0841-4d4c-ab2e-f6c9270657dc_0f9486d1-9871-4e02-abc0-d3c31a6ef65e.html,,,,,, "2-[10-(acetyloxy)-9a,11a-dimethyl-7-oxo-3H,3aH,3bH,4H,5H,7H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-1-yl]-2-oxoethyl acetate",23825-05-0," Based on the results of oral acute toxicity studies with two structural analogues prednisolone and 16alpha-hydroxyprednisolone, Prediac-Z is considered not acutely toxic by oral route (LD50 > 2000 mg/kg bw). ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b33ce0f2-08f5-4f9d-b6b9-1d8b4ff54470/documents/acf008a2-87a2-4ee4-83ca-4b6037efa1f5_c5a3961e-b2af-4433-8d77-662d2f3f70df.html,,,,,, "2-[10-(acetyloxy)-9a,11a-dimethyl-7-oxo-3H,3aH,3bH,4H,5H,7H,9aH,9bH,10H,11H,11aH-cyclopenta[a]phenanthren-1-yl]-2-oxoethyl acetate",23825-05-0,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b33ce0f2-08f5-4f9d-b6b9-1d8b4ff54470/documents/acf008a2-87a2-4ee4-83ca-4b6037efa1f5_c5a3961e-b2af-4433-8d77-662d2f3f70df.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-[2-(2-ethoxyethoxy)ethoxy]ethyl methacrylate,39670-09-2,"Subacute study; oral (gavage); rat (Hsd: Sprague Dawley SD), m/f (OECD guideline 422, GLP), NOAEL = 1000 mg/kg bw/d (Klimisch score:1, RTC, 2013) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4102b0f3-7cbc-4662-a3f6-7a92eec96924/documents/IUC5-a8c31857-e760-4627-934f-d43fab663d5d_e04e3019-8623-4c1c-b59e-d3a21d98c3bc.html,,,,,, 2-[2-(2-ethoxyethoxy)ethoxy]ethyl methacrylate,39670-09-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4102b0f3-7cbc-4662-a3f6-7a92eec96924/documents/IUC5-a8c31857-e760-4627-934f-d43fab663d5d_e04e3019-8623-4c1c-b59e-d3a21d98c3bc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-[2-(2-ethoxyethoxy)ethoxy]ethyl methacrylate,39670-09-2,"Ethyltriglycol methacrylate is of low acute oral and dermal toxicity. LD50 is higher than 2000 mg/kg bw in rats. Acute oral toxicity: LD50 (rat, combined) >= 5100 mg/kg bw; OECD Guideline 401, Non-GLP (Klimisch score = 2) (International Bio-Research (IBR) Forschungs GmbH, 1986) Supported by LD50 (rat, combined, limit test): > 2000 mg/kg/bw, OECD Guideline 401, GLP (Klimisch score = 1) (C.I.T. Centre International de Toxicologie, 1991)Acute inhalation toxicity: no relevant route of exposureAcute dermal toxicity: LD50 (rat) > 2000 mg/kg bw, Gudeline study according to OECD 402 with GLP (Klimisch score = 1) (BSL BIOSERVICE Scientific Laboratory GmbH, 2011) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4102b0f3-7cbc-4662-a3f6-7a92eec96924/documents/IUC5-5219f170-2214-455d-98ba-508a169cc36f_e04e3019-8623-4c1c-b59e-d3a21d98c3bc.html,,,,,, 2-[2-(2-ethoxyethoxy)ethoxy]ethyl methacrylate,39670-09-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4102b0f3-7cbc-4662-a3f6-7a92eec96924/documents/IUC5-5219f170-2214-455d-98ba-508a169cc36f_e04e3019-8623-4c1c-b59e-d3a21d98c3bc.html,,oral,LD50,"5,100 mg/kg bw",no adverse effect observed, 2-[2-(2-ethoxyethoxy)ethoxy]ethyl methacrylate,39670-09-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4102b0f3-7cbc-4662-a3f6-7a92eec96924/documents/IUC5-5219f170-2214-455d-98ba-508a169cc36f_e04e3019-8623-4c1c-b59e-d3a21d98c3bc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-[2-(3-aminopropoxy)ethoxy]ethanol,112-33-4,oral - LD50 male = 6500 mg/kg bw - Smyth et al. 1969inhalation/whole body - no mortality observed - Smyth et al. 1969dermal - LD50 male = 6330 mg/kg bw - Smyth et al. 1969 ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5598d5d8-408e-4c60-8ff3-94314537b154/documents/IUC5-b93434f0-b2ce-44dd-b848-eeec5be98246_51153763-0f6c-4c19-9837-e00eb83d5761.html,,,,,, 2-[2-(dimethylamino)ethoxy]ethanol,1704-62-7," There are two repeated dose toxicity studies on 2-[2-(dimethylamino)ethoxy]ethanol available: - OECD 422 [BASF, 2020]: NOAEL = 250 mg/kg bw - OECD 408 [BASF, 2020]: NOAEL = 250 mg/kg bw ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47f0310e-e4e5-4658-a980-d0f7c5193da7/documents/517b06b0-3775-41e5-b69e-84bcfd6d8732_15b7c244-7543-4b10-a824-9230e4a71be0.html,,,,,, 2-[2-(dimethylamino)ethoxy]ethanol,1704-62-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47f0310e-e4e5-4658-a980-d0f7c5193da7/documents/517b06b0-3775-41e5-b69e-84bcfd6d8732_15b7c244-7543-4b10-a824-9230e4a71be0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 2-[2-(dimethylamino)ethoxy]ethanol,1704-62-7," Oral (OECD Guideline 401), Dermal (OECD Guideline 402) and Inhalation (OECD Guideline 403) tests were conducted on DMEE. Toxicity in the oral gavage study was dose dependent for males and females with an LC50 of 2150 - 3830 mg/kg bw. Toxicity in the dermal study was also dose dependent and the observed LD50 was 1.74 mL/kg bw for males and 2.14 mL/kg bw for females. The potential LC50 for male and female rats exposed to the test substance for 4 hours via the inhalation route is > 72 ppm, which was the maximum concentration tested. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47f0310e-e4e5-4658-a980-d0f7c5193da7/documents/240fb435-c45f-4900-b19c-bce685b3b14e_15b7c244-7543-4b10-a824-9230e4a71be0.html,,,,,, 2-[2-(dimethylamino)ethoxy]ethanol,1704-62-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47f0310e-e4e5-4658-a980-d0f7c5193da7/documents/240fb435-c45f-4900-b19c-bce685b3b14e_15b7c244-7543-4b10-a824-9230e4a71be0.html,,oral,LD50,"2,150 mg/kg bw",adverse effect observed, 2-[2-(dimethylamino)ethoxy]ethanol,1704-62-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47f0310e-e4e5-4658-a980-d0f7c5193da7/documents/240fb435-c45f-4900-b19c-bce685b3b14e_15b7c244-7543-4b10-a824-9230e4a71be0.html,,dermal,LD50,"1,663 mg/kg bw",adverse effect observed, 2-[2-(dimethylamino)ethoxy]ethanol,1704-62-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47f0310e-e4e5-4658-a980-d0f7c5193da7/documents/240fb435-c45f-4900-b19c-bce685b3b14e_15b7c244-7543-4b10-a824-9230e4a71be0.html,,inhalation,LC50,392.2 mg/m3,no adverse effect observed, "2-[2-[4-(dimethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate",71598-17-9," The acute oral toxicity was determined in a study equivalent to OECD guideline 401. The LD50, rats oral was determined to be: 493 mg/kg bw (recalculated based on dye content of registered substance versus tested material). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/864455a3-b38f-4cc3-8424-714b07f9a0a7/documents/IUC5-5243d0c7-4d35-45fc-b16b-ade8ab9cc12d_cc20ae86-0d55-4045-8ff4-cd7b862b85af.html,,,,,, "2-[2-[4-(dimethylamino)phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate",71598-17-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/864455a3-b38f-4cc3-8424-714b07f9a0a7/documents/IUC5-5243d0c7-4d35-45fc-b16b-ade8ab9cc12d_cc20ae86-0d55-4045-8ff4-cd7b862b85af.html,,oral,LD50,493 mg/kg bw,adverse effect observed, "2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride",6441-82-3," Prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride (6441-82-3 ). The study assumed the use of male and female Wistar rats in subchronic study of 8 months. No significant alterations were noted at the dose level of 515.59mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for Dialkyl(C1-C14)dithiophosphoric acid, zinc salt is considered to be 515.59mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92531882-59cb-4999-b5ab-befd123c59cb/documents/ae563ebb-2fb0-47c6-b8fc-01d6eb7506a7_92993392-96db-4d68-aa6f-dbb6c9cce437.html,,,,,, "2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride",6441-82-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92531882-59cb-4999-b5ab-befd123c59cb/documents/ae563ebb-2fb0-47c6-b8fc-01d6eb7506a7_92993392-96db-4d68-aa6f-dbb6c9cce437.html,Chronic toxicity – systemic effects,oral,NOAEL,515.59 mg/kg bw/day,,rat "2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride",6441-82-3," Acute oral toxicity:  Acute oral toxicity dose (LD50) of 2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride was predicted based on OECD QSAR toolbox 3443mg/kg bw and different studies available on structurally similar read across substance 2-[2-[4-[(2-chloroethyl)methylamino]phenyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride (CAS no: 3648-36-0) 2260 mg/kg bw and for the closely related read across substance 2,2-Dichloro-1-(3-methyl-2,3-dihydro-4H-1,4-benzoxazin-4-yl)ethanone (CAS no: 98730-04-2) 5000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride can be classified as category V of acute oral toxicity. Acute Inhalation toxicity:  Acute Inhalation toxicity dose (LC50) of 2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride was predicted based on OECD QSAR toolbox 22.9 mg/L air, and different studies available for the closely related read across substance Bromochloromethane (CAS no: 74-97-5) 12030 mg/m3 and Tris(2-chloro-1-methylethyl) phosphate (CAS no: 13674-84-5) >4600 mg/m3. All these studies concluded that the LC50 value is greater than 5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, 2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride can be classified as category V of acute inhalation toxicity. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for 2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride was predicted based on OECD QSAR toolbox 4242 mg/kg bwand differentstudies available on closely related read across substance3-Chloropropyl)triethoxysilane (CAS No. 5089-70-3) >2000 mg/kg bw and Tris(2-chloro-1-methylethyl) phosphate (13674-84-5) >2000 mg/kg bw. All these studies concluded that the LD50 value is>2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride can be classified as category V of acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92531882-59cb-4999-b5ab-befd123c59cb/documents/d490480a-386e-45de-a712-e118516be0e6_92993392-96db-4d68-aa6f-dbb6c9cce437.html,,,,,, "2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride",6441-82-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92531882-59cb-4999-b5ab-befd123c59cb/documents/d490480a-386e-45de-a712-e118516be0e6_92993392-96db-4d68-aa6f-dbb6c9cce437.html,,oral,LD50,"3,443 mg/kg bw",no adverse effect observed, "2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride",6441-82-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92531882-59cb-4999-b5ab-befd123c59cb/documents/d490480a-386e-45de-a712-e118516be0e6_92993392-96db-4d68-aa6f-dbb6c9cce437.html,,dermal,LD50,"4,242 mg/kg bw",no adverse effect observed, "2-[2-[4-[(2-chloroethyl)ethylamino]-o-tolyl]vinyl]-1,3,3-trimethyl-3H-indolium chloride",6441-82-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92531882-59cb-4999-b5ab-befd123c59cb/documents/d490480a-386e-45de-a712-e118516be0e6_92993392-96db-4d68-aa6f-dbb6c9cce437.html,,inhalation,LC50,"22,900 mg/m3",no adverse effect observed, "2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate",65122-06-7, Acute oral toxicity: LD50 = 1600 mg/kg in rats. Acute inhalation toxicity: no mortality up to 2.345 mg/l and 0.688 mg/l in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6299e27-0a43-4320-ae8b-6e1ed686c332/documents/IUC5-218a12ba-d17b-44c2-9f39-3d696169e477_afc709b5-cec1-4405-ab0a-e5d87df1673c.html,,,,,, "2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]vinyl]-1,3,3-trimethyl-3H-indolium acetate",65122-06-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6299e27-0a43-4320-ae8b-6e1ed686c332/documents/IUC5-218a12ba-d17b-44c2-9f39-3d696169e477_afc709b5-cec1-4405-ab0a-e5d87df1673c.html,,oral,LD50,"1,600 mg/kg bw",adverse effect observed, "2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]vinyl]-1,3,3-trimethyl-3H-indolium dihydrogen phosphate",72208-21-0, Acute oral toxicity: LD50 = 1600 mg/kg in rats. Acute inhalation toxicity: no mortality up to 2.345 mg/l and 0.688 mg/l in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7832d813-7c91-4d95-bf0e-8231b94c95ac/documents/IUC5-218a12ba-d17b-44c2-9f39-3d696169e477_42db7574-16ab-4338-83eb-1dceec66b9d4.html,,,,,, "2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]vinyl]-1,3,3-trimethyl-3H-indolium dihydrogen phosphate",72208-21-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7832d813-7c91-4d95-bf0e-8231b94c95ac/documents/IUC5-218a12ba-d17b-44c2-9f39-3d696169e477_42db7574-16ab-4338-83eb-1dceec66b9d4.html,,oral,LD50,"1,600 mg/kg bw",adverse effect observed, "2-[2-[4-[(2-cyanoethyl)methylamino]phenyl]vinyl]-1,3,3-trimethyl-3H-indolium hydrogen sulphate",72319-18-7, The LD50 for acute oral toxicity of the substance was determined to be between 300 and 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93386ad2-655c-43a7-bf66-41141af51e71/documents/IUC5-88c73313-7246-4e84-88cb-4a19f715fd91_f2cd41cb-b3be-43e4-b32a-5e096b71cc8d.html,,,,,, 2-[2-[4-[2-(4-cyanophenyl)vinyl]phenyl]vinyl]benzonitrile,13001-38-2, Acute oral toxicity in rats: LD50 > 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17ca037f-f521-4bf1-a7d3-b9fcef022ddb/documents/6ef45d5e-7265-4982-b3cd-cc9e251e3c0b_5d52be43-345f-400b-a0ab-dee13aec6997.html,,,,,, "2-[3-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)prop-1-enyl]-1,3,3-trimethyl-3H-indolium acetate",65122-08-9," the LD50 is based on a substance that contains 26% acetic acid (LD50 > 2000 mg/kg bw), 20.4% acetic anhydride (LD50 630 mg/kg bw). The LD50 as available there needs to be correct for at least these two components. This is done with a reversed ATE calculation males: (100 -67)/243=26/2000 + 20.4/630 + 20.7/ATE --> this leads to an ATE of 230 mg/kg bw for BR12 females (100 -67)/154=26/2000 + 20.4/630 + 20.7/ATE --> this leads to an ATE of 122 mg/kg bw for BR12 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c045fbf3-f852-4948-9a76-93cb5716d512/documents/30a6ce81-8f96-48c7-9729-2ef03e07749d_35c3ee89-6fdb-4485-80e4-73e6e16d37f1.html,,,,,, "2-[3-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)prop-1-enyl]-1,3,3-trimethyl-3H-indolium acetate",65122-08-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c045fbf3-f852-4948-9a76-93cb5716d512/documents/30a6ce81-8f96-48c7-9729-2ef03e07749d_35c3ee89-6fdb-4485-80e4-73e6e16d37f1.html,,oral,LD50,122 mg/kg bw,adverse effect observed, "2-[3-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)prop-1-enyl]-1,3,3-trimethyl-3H-indolium chloride",6320-14-5," Acute oral toxicity:  In Acute oral toxicity,LD50 value for target substance 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5) was considered to be 31 mg/kg bw and 25 mg/kg bw in males and females rats respectively and 18 mg/kg bw in rats in another experimental study. All these studies concluded that the LD50 value is between 5-50 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5) can be classified as “Category II” for acute oral toxicity. Acute Inhalation Toxicity:  1,3,3-trimethyl-2-[(1E)-3-[(2E)-1,3,3-trimethyl-2,3-dihydro-1H-indol-2-ylidene]prop-1-en-1-yl]-3H-indol-1-ium chloride (6320-14-5) has very low vapour pressure (1.42e-011Pa= 1.06509e-13 mmHg).So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5413ff72-0319-4ba1-88f3-b86e6175e7b1/documents/bb49a49b-e4f9-4fbd-b104-665906cea793_8dc05185-d16f-4d75-98e1-a6db0c8ec1a9.html,,,,,, "2-[3-(1,3-dihydro-1,3,3-trimethyl-2H-indol-2-ylidene)prop-1-enyl]-1,3,3-trimethyl-3H-indolium chloride",6320-14-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5413ff72-0319-4ba1-88f3-b86e6175e7b1/documents/bb49a49b-e4f9-4fbd-b104-665906cea793_8dc05185-d16f-4d75-98e1-a6db0c8ec1a9.html,,oral,LD50,31 mg/kg bw,adverse effect observed, "2-[3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazoniol-5-yl]ethyl dihydrogen diphosphate",136-09-4," Oral, male rats: LD50 = 3710 mg/kg bw (RA CAS 67-03-8) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/699bea05-2546-4132-975a-8db38a8c1041/documents/b085c3b3-2172-471d-beec-6c5c31e0b09b_720c85d2-1cf6-4083-877e-822549b49767.html,,,,,, "2-[3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazoniol-5-yl]ethyl dihydrogen diphosphate",136-09-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/699bea05-2546-4132-975a-8db38a8c1041/documents/b085c3b3-2172-471d-beec-6c5c31e0b09b_720c85d2-1cf6-4083-877e-822549b49767.html,,oral,LD50,"3,710 mg/kg bw",adverse effect observed, "2-[4-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)phenyl]butyric acid",94232-67-4, Oral: The oral LD50 value of the test item in Wistar rat was established to exceed 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee41060d-5505-48a5-865a-8b4c2be6fe36/documents/2eabf65c-57ed-4b0b-94fc-a3a282690905_cd177eb6-58c9-454d-800d-e6aba29187e9.html,,,,,, "2-[4-(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)phenyl]butyric acid",94232-67-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee41060d-5505-48a5-865a-8b4c2be6fe36/documents/2eabf65c-57ed-4b0b-94fc-a3a282690905_cd177eb6-58c9-454d-800d-e6aba29187e9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-[4-[(2-chloro-4-nitrophenyl)azo]-N-(2-cyanoethyl)anilino]ethyl acetate,6021-61-0, Oral LD50 (male and female) > 5350 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27afafea-1aff-412e-80ed-1ff8763e9d0f/documents/32ad92c1-2299-4452-9a1b-d5ab94448704_38618437-6782-4df9-8526-7ed3fecee127.html,,,,,, 2-[4-[(2-chloro-4-nitrophenyl)azo]-N-(2-cyanoethyl)anilino]ethyl acetate,6021-61-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27afafea-1aff-412e-80ed-1ff8763e9d0f/documents/32ad92c1-2299-4452-9a1b-d5ab94448704_38618437-6782-4df9-8526-7ed3fecee127.html,,oral,LD50,"5,350 mg/kg bw",no adverse effect observed, "2-[4-[(hexahydro-2,4,6-trioxo-5-pyrimidyl)azo]phenyl]-6-methylbenzothiazole-7-sulphonic acid, compound with 2,2',2''-nitrilotris[ethanol] (1:1)",65036-46-6, In a GLP compliant OECD 422 combined repeated dose toxicity study with the reproductive/developmental screening test in Wistar rats the oral administration of the read-across substance by oral gavage to male and female Wistar rats did not result in signs of systemic toxicity up to a dose level of 1000 mg/kg bw/d. The no observed adverse effect level (NOAEL) for general systemic toxicity was 1000 mg/kg bw/d for males and females. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8535b7d5-5b96-4272-a550-b19bf215e919/documents/acdf17a2-6682-405d-bb74-71f7f1c22a09_2ecac6bb-1da2-43c8-a817-0bb9527d4779.html,,,,,, "2-[4-[(hexahydro-2,4,6-trioxo-5-pyrimidyl)azo]phenyl]-6-methylbenzothiazole-7-sulphonic acid, compound with 2,2',2''-nitrilotris[ethanol] (1:1)",65036-46-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8535b7d5-5b96-4272-a550-b19bf215e919/documents/acdf17a2-6682-405d-bb74-71f7f1c22a09_2ecac6bb-1da2-43c8-a817-0bb9527d4779.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-[4-[(hexahydro-2,4,6-trioxo-5-pyrimidyl)azo]phenyl]-6-methylbenzothiazole-7-sulphonic acid, compound with 2,2',2''-nitrilotris[ethanol] (1:1)",65036-46-6," In a valid GLP OECD 423 study in female rats, a single dose of the registered substance at 2000mg/kg bw resulted in no mortality, therefore leading to a LD50 at the cut-off value of 5000mg/kg bw. There were no signs of toxicity in any animal of step 1. However, all animals of step 2 showed slight signs of acute oral toxicity. The most relevant clinical finding in the animals of step 2 treated with the test item at a dose of 2000 mg/kg bw was piloerection between 120 min and 240 min post-application. No clinical signs were recorded in all animals of step 2 240 min after administration until end of study. Throughout the 14-day observation period, the body weight gain of the test animals was within the normal range of variation for this strain. At necropsy, no macroscopic findings were observed in any animal of any step. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8535b7d5-5b96-4272-a550-b19bf215e919/documents/91356e9b-de04-4fb0-9d44-1d04c3e74ee1_2ecac6bb-1da2-43c8-a817-0bb9527d4779.html,,,,,, "2-[4-[(hexahydro-2,4,6-trioxo-5-pyrimidyl)azo]phenyl]-6-methylbenzothiazole-7-sulphonic acid, compound with 2,2',2''-nitrilotris[ethanol] (1:1)",65036-46-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8535b7d5-5b96-4272-a550-b19bf215e919/documents/91356e9b-de04-4fb0-9d44-1d04c3e74ee1_2ecac6bb-1da2-43c8-a817-0bb9527d4779.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-[4-[[2-(cyanoimino)hexahydro-4,6-dioxo-5-pyrimidyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonic acid, compound with 2,2',2''-nitrilotris[ethanol] (1:1)",55067-15-7, The no observed adverse effect level (NOAEL) for general systemic toxicity for the read-across substance (Similar Substance 01) was determined to be 1000 mg/kg bw/d for male and female Wistar rats. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/656c3bf5-4066-4ea9-bc64-1287a4b621b0/documents/499b2c05-3898-4823-8122-d4c67c86c31a_32d8a581-9bfe-4e63-916e-b969bf491894.html,,,,,, "2-[4-[[2-(cyanoimino)hexahydro-4,6-dioxo-5-pyrimidyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonic acid, compound with 2,2',2''-nitrilotris[ethanol] (1:1)",55067-15-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/656c3bf5-4066-4ea9-bc64-1287a4b621b0/documents/499b2c05-3898-4823-8122-d4c67c86c31a_32d8a581-9bfe-4e63-916e-b969bf491894.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-[4-[[2-(cyanoimino)hexahydro-4,6-dioxo-5-pyrimidyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonic acid, compound with 2,2',2''-nitrilotris[ethanol] (1:1)",55067-15-7, Acute oral toxicity: The LD50 of the test substance was found to be greater than 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/656c3bf5-4066-4ea9-bc64-1287a4b621b0/documents/IUC5-7402b60e-2af1-4852-aeab-ff5f04fa26df_32d8a581-9bfe-4e63-916e-b969bf491894.html,,,,,, "2-[4-[[2-(cyanoimino)hexahydro-4,6-dioxo-5-pyrimidyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonic acid, compound with 2,2',2''-nitrilotris[ethanol] (1:1)",55067-15-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/656c3bf5-4066-4ea9-bc64-1287a4b621b0/documents/IUC5-7402b60e-2af1-4852-aeab-ff5f04fa26df_32d8a581-9bfe-4e63-916e-b969bf491894.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-[bis(2-ethylhexyl)amino]ethanol,101-07-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): sufficient Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): sufficient ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc687a40-8806-42cc-992f-241ab99885d5/documents/2b6a16f7-2b5a-484c-94c1-691b131e6120_78b5fdff-7f21-4e7b-b5be-a134e7b36936.html,,,,,, 2-[bis(2-ethylhexyl)amino]ethanol,101-07-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc687a40-8806-42cc-992f-241ab99885d5/documents/2b6a16f7-2b5a-484c-94c1-691b131e6120_78b5fdff-7f21-4e7b-b5be-a134e7b36936.html,,oral,LD50,"4,900 mg/kg bw",adverse effect observed, 2-[bis(2-ethylhexyl)amino]ethanol,101-07-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc687a40-8806-42cc-992f-241ab99885d5/documents/2b6a16f7-2b5a-484c-94c1-691b131e6120_78b5fdff-7f21-4e7b-b5be-a134e7b36936.html,,dermal,LD50,"2,500 mg/kg bw",adverse effect observed, "2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)-1,3-propanediol hydrochloride",124763-51-5," In a GLP-study according to OECD TG 423 (acute class method) with rats, the LD50 of the read-across substance was determined as > 2000 mg/kg bw (reference 7.2.1 -1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8cff3152-7dd1-4c51-9aaf-3134816bfafe/documents/144bee13-817d-4189-8a7f-1379ca98bf61_2b1c3f9c-491b-40c5-82ce-990fbddec9e7.html,,,,,, "2-[bis(2-hydroxyethyl)amino]-2-(hydroxymethyl)-1,3-propanediol hydrochloride",124763-51-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8cff3152-7dd1-4c51-9aaf-3134816bfafe/documents/144bee13-817d-4189-8a7f-1379ca98bf61_2b1c3f9c-491b-40c5-82ce-990fbddec9e7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-[bis(2-hydroxyethyl)amino]ethanesulphonic acid,10191-18-1, The substance has not been directly tested on animals An assessment of toxicity has been made that concludes that the toxicity can be predicted by considering the closely related natural amino acid Taurine and the toxicity ot teriary amines. Tauring and diethanolamine are both of low acute toxic hazard and it is predicted that the toxicity of 2-[bis(2-hydroxyethyl)amino]ethanesulphonic acid is low with an acute oral disciminating dose > 2000 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58e1c6b1-17f0-4d61-8552-12ce1a470712/documents/e0a71b33-5ed1-4165-a829-7ea7cd013b8a_47f1708c-9b09-4727-a06d-532fcdd610b6.html,,,,,, 2-[bis(2-hydroxyethyl)amino]ethanesulphonic acid,10191-18-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58e1c6b1-17f0-4d61-8552-12ce1a470712/documents/e0a71b33-5ed1-4165-a829-7ea7cd013b8a_47f1708c-9b09-4727-a06d-532fcdd610b6.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-[methyl[(nonafluorobutyl)sulphonyl]amino]ethyl acrylate,67584-55-8,Acute Oral LD50 > 2000 mg/kgAcute Dermal L50 > 2000 mg/kg ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fbc7b40b-ad91-4a4b-ad2a-2c748e0fa397/documents/IUC5-b738759a-3c0b-4efe-a2c9-01399d100b33_f4637b5d-4cf7-41de-9279-b9c87680f0b5.html,,,,,, 2-[methyl[(nonafluorobutyl)sulphonyl]amino]ethyl methacrylate,67584-59-2," An acute oral lethality study was conducted on C4 Methacrylate and an acute dermal lethality study was conducted on a C4 Acrylate (structural analogue): The acute oral LD50 is greater than 2,000 mg/kg when tested according to OECD 420 (2001). The acute dermal LD50 is greater than 2,000 mg/kg when tested according to OECD 402 (1987). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c091af0-3a41-47cb-9007-5189d4e60774/documents/cfe7cd3f-b998-44ca-8579-82aa8e8ddb98_ccee2518-0214-4038-b83d-4a6230ff9ede.html,,,,,, "2-[N-(2-cyanoethyl)-4-[(2,6-dichloro-4-nitrophenyl)azo]anilino]ethyl acetate",5261-31-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13650117-0b16-44bf-adb7-f749e7b690d5/documents/a15a92d6-0410-4896-acac-c7ead48aebe3_ac0dd792-cffd-4b50-bbe5-c1ffc971c99c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "2-[N-(2-cyanoethyl)-4-[(2,6-dichloro-4-nitrophenyl)azo]anilino]ethyl acetate",5261-31-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13650117-0b16-44bf-adb7-f749e7b690d5/documents/e46cd98e-b792-47e5-ad17-851283d00258_ac0dd792-cffd-4b50-bbe5-c1ffc971c99c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-[-N-(2-cyanoethyl)-4-[(p-nitrophenyl)azo]anilino]ethyl benzoate,40690-89-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The lowest LD50 value in a weight-of-evidence approach was determined at >2000 mg/kg bw for one of the source substances. Therefore, the classification criteria for CLP are not met (LD50 oral >2000 mg/kg bw). No difference in acute toxicity is assumed for the target substance. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4814ce8e-fab5-4399-8e37-bc01c6520e6b/documents/b0a60add-8e6e-4549-93d6-98d7b581ca2e_29cdac08-0c34-4c4a-8a9f-a91ba6630ed3.html,,,,,, 2-[tert-butyl(phenylmethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl] hydrochloride,24085-08-3,"The acute oral and dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight, respectively. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56eeb338-8a20-44eb-9c5c-97f23f95fb1b/documents/IUC5-81f6c424-b9ec-4e56-bb85-5170993f64ad_b721f376-9d95-4a78-9746-684225751b20.html,,,,,, 2-[tert-butyl(phenylmethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl] hydrochloride,24085-08-3,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56eeb338-8a20-44eb-9c5c-97f23f95fb1b/documents/IUC5-81f6c424-b9ec-4e56-bb85-5170993f64ad_b721f376-9d95-4a78-9746-684225751b20.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-[tert-butyl(phenylmethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl] hydrochloride,24085-08-3,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56eeb338-8a20-44eb-9c5c-97f23f95fb1b/documents/IUC5-81f6c424-b9ec-4e56-bb85-5170993f64ad_b721f376-9d95-4a78-9746-684225751b20.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-{(E)-[6-({4-chloro-6-[(4-{[2-(sulfooxy)ethyl]sulfonyl}phenyl)amino]-1,3,5-triazin-2-yl}amino)-1-hydroxy-3-sulfonaphthalen-2-yl]diazenyl}naphthalene-1,5-disulfonic acid",79809-27-1," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 3.70E-42 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b38654d-33b0-4621-9346-764e12ca72e0/documents/21339418-7fa2-455e-93fd-0ccc6e9447d6_a43c81fb-c9a3-49c7-8b4f-5cfdb5cdbdd8.html,,,,,, "2-{(E)-[6-({4-chloro-6-[(4-{[2-(sulfooxy)ethyl]sulfonyl}phenyl)amino]-1,3,5-triazin-2-yl}amino)-1-hydroxy-3-sulfonaphthalen-2-yl]diazenyl}naphthalene-1,5-disulfonic acid",79809-27-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b38654d-33b0-4621-9346-764e12ca72e0/documents/21339418-7fa2-455e-93fd-0ccc6e9447d6_a43c81fb-c9a3-49c7-8b4f-5cfdb5cdbdd8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-{(E)-[6-({4-chloro-6-[(4-{[2-(sulfooxy)ethyl]sulfonyl}phenyl)amino]-1,3,5-triazin-2-yl}amino)-1-hydroxy-3-sulfonaphthalen-2-yl]diazenyl}naphthalene-1,5-disulfonic acid",79809-27-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b38654d-33b0-4621-9346-764e12ca72e0/documents/21339418-7fa2-455e-93fd-0ccc6e9447d6_a43c81fb-c9a3-49c7-8b4f-5cfdb5cdbdd8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-{[2,2,4-trifluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}ethanol",1190931-34-0, Results from 2 reliable studies in rats administered the substance by the oral or dermal route indicate adverse effects by the oral route only. The acute oral LD50 is between 300 mg/kg (no mortality) and 2000 mg/kg (100% mortality). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a8ca77c-6c6b-4d64-8c52-691afe6d95b4/documents/c731afcd-fb2f-4b38-9754-58dc2549952f_4d5f7263-f2b0-4912-b2ba-4b9b0a12913f.html,,,,,, "Reaction products of Benzoic acid, 2-[[4-chloro-6-[[8-hydroxy-3,6-disulfo-7-[(1-sulfo-2-naphthalenyl)azo]-1-naphthalenyl]amino]-1,3,5-triazin-2-yl]amino]-5-sulfo-, pentasodium salt and lithium chloride",118578-12-4,Most azo dyes have acute oral and dermal toxicity discriminating dose > 2000 mg/kg. The similar substances and the test substance reviewed fall into this category. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3baa8d62-fa48-4a8d-8565-cc8a7ce039ec/documents/IUC5-df6f2cdc-6a24-44a7-af5a-eed6d91f7216_4f9a3250-f2eb-46a9-a247-a6607bf5482f.html,,,,,, "Reaction products of Benzoic acid, 2-[[4-chloro-6-[[8-hydroxy-3,6-disulfo-7-[(1-sulfo-2-naphthalenyl)azo]-1-naphthalenyl]amino]-1,3,5-triazin-2-yl]amino]-5-sulfo-, pentasodium salt and lithium chloride",118578-12-4,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3baa8d62-fa48-4a8d-8565-cc8a7ce039ec/documents/IUC5-df6f2cdc-6a24-44a7-af5a-eed6d91f7216_4f9a3250-f2eb-46a9-a247-a6607bf5482f.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Reaction products of Benzoic acid, 2-[[4-chloro-6-[[8-hydroxy-3,6-disulfo-7-[(1-sulfo-2-naphthalenyl)azo]-1-naphthalenyl]amino]-1,3,5-triazin-2-yl]amino]-5-sulfo-, pentasodium salt and lithium chloride",118578-12-4,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3baa8d62-fa48-4a8d-8565-cc8a7ce039ec/documents/IUC5-df6f2cdc-6a24-44a7-af5a-eed6d91f7216_4f9a3250-f2eb-46a9-a247-a6607bf5482f.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-{2-chloro-4-mesyl-3-[(tetrahydrofuran-2-ylmethoxy)methyl]benzoyl}cyclohexane-1,3-dione",473278-76-1," subacute toxicity: OECD 410, dermal, rat, 28-days: NOAEL = 10 mg/kg bw/day subchronic toxicity: OECD 408, oral, rat, 90-days: NOAEL = 259 mg/kg bw/day (males) and 902 mg/kg bw/day (females) OECD 409, oral, dog, 90-days: LOAEL = 0.564 mg/kg bw/day (males) and 0.591 mg/kg bw/day (females); NOAEL < 0.564 mg/kg bw/day (males) and < 0.591 mg/kg bw/day (females) chronic toxicity: OECD 453, oral, rat, 24 months: NOAEL = 0.08 mg/kg bw/day (males) and 0.11 mg/kg bw/day (females) OECD 452, oral, dog, 1-year: NOAEL = 0.102 mg/kg bw/day (males and females) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d305a457-45fe-41f3-8481-da07446e5df6/documents/86e6cea5-8a18-410b-b2b8-7666bb3fb8de_58a09ce3-0386-4042-baab-b7e65e56d596.html,,,,,, "2-{2-chloro-4-mesyl-3-[(tetrahydrofuran-2-ylmethoxy)methyl]benzoyl}cyclohexane-1,3-dione",473278-76-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d305a457-45fe-41f3-8481-da07446e5df6/documents/86e6cea5-8a18-410b-b2b8-7666bb3fb8de_58a09ce3-0386-4042-baab-b7e65e56d596.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rat "2-{2-chloro-4-mesyl-3-[(tetrahydrofuran-2-ylmethoxy)methyl]benzoyl}cyclohexane-1,3-dione",473278-76-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d305a457-45fe-41f3-8481-da07446e5df6/documents/86e6cea5-8a18-410b-b2b8-7666bb3fb8de_58a09ce3-0386-4042-baab-b7e65e56d596.html,Chronic toxicity – systemic effects,oral,NOAEL,0.08 mg/kg bw/day,,rat "2-{2-chloro-4-mesyl-3-[(tetrahydrofuran-2-ylmethoxy)methyl]benzoyl}cyclohexane-1,3-dione",473278-76-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d305a457-45fe-41f3-8481-da07446e5df6/documents/86e6cea5-8a18-410b-b2b8-7666bb3fb8de_58a09ce3-0386-4042-baab-b7e65e56d596.html,Repeated dose toxicity – local effects,dermal,NOAEL,5.16 mg/cm2,no adverse effect observed,rat "2-{2-chloro-4-mesyl-3-[(tetrahydrofuran-2-ylmethoxy)methyl]benzoyl}cyclohexane-1,3-dione",473278-76-1," Oral (OECD 423), rat: LD50 cut-off value = 5000 mg/kg bw Oral (equivalent or similar to OECD 423), mouse: LD50 >2000 mg/kg bw Inhalation (similar to OECD 403), rat: LC50 > 1.34 mg/L air Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d305a457-45fe-41f3-8481-da07446e5df6/documents/11d2af08-c578-4ffa-90e9-ac8c9de6806c_58a09ce3-0386-4042-baab-b7e65e56d596.html,,,,,, "2-{2-chloro-4-mesyl-3-[(tetrahydrofuran-2-ylmethoxy)methyl]benzoyl}cyclohexane-1,3-dione",473278-76-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d305a457-45fe-41f3-8481-da07446e5df6/documents/11d2af08-c578-4ffa-90e9-ac8c9de6806c_58a09ce3-0386-4042-baab-b7e65e56d596.html,,oral,LD50,">=5,000 mg/kg bw",no adverse effect observed, "2-{2-chloro-4-mesyl-3-[(tetrahydrofuran-2-ylmethoxy)methyl]benzoyl}cyclohexane-1,3-dione",473278-76-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d305a457-45fe-41f3-8481-da07446e5df6/documents/11d2af08-c578-4ffa-90e9-ac8c9de6806c_58a09ce3-0386-4042-baab-b7e65e56d596.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2-{2-chloro-4-mesyl-3-[(tetrahydrofuran-2-ylmethoxy)methyl]benzoyl}cyclohexane-1,3-dione",473278-76-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d305a457-45fe-41f3-8481-da07446e5df6/documents/11d2af08-c578-4ffa-90e9-ac8c9de6806c_58a09ce3-0386-4042-baab-b7e65e56d596.html,,inhalation,LC50,> 1.34 mg/L,no adverse effect observed, "2-{3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-4-methyl-1,3-thiazol-3-ium-5-yl}ethyl hydrogen phosphate",10023-48-0," Oral, male rats: LD50 = 3710 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7613ef55-f8cb-4d93-a16e-642f29494e0a/documents/bb4638a5-c0f2-4959-8f8e-1474adbb98cf_b2219d1a-e9a9-4662-b9dc-e56875a5d47a.html,,,,,, "2-{4-[2-(4,4-dimethyl-4,5-dihydro-1,3-oxazol-2-yl)propan-2-yl]phenyl}ethyl 4-methylbenzenesulfonate",202189-76-2, Acute toxicity: oral. Key study: According to OECD guideline 423 and test method B1. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/705a1c64-c7c4-443f-bab5-98473cb3a045/documents/3d700f2d-2ab0-4631-b016-aa67fe5981e9_7df7014b-1c9b-4864-aeef-c8ea1b3dfa96.html,,,,,, "2-{4-[2-(4,4-dimethyl-4,5-dihydro-1,3-oxazol-2-yl)propan-2-yl]phenyl}ethyl 4-methylbenzenesulfonate",202189-76-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/705a1c64-c7c4-443f-bab5-98473cb3a045/documents/3d700f2d-2ab0-4631-b016-aa67fe5981e9_7df7014b-1c9b-4864-aeef-c8ea1b3dfa96.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Acetone, polymer with phenol",35238-34-7,"Bisphenol A, a structural analog for 2-Acetone polymer with phenol (BPA-Tars) was assessed for systemic adverse effects in a manner similar to O.E.C.D. Test Guideline No. 408 90-day subchronic feeding study in rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/374d9a8e-757c-445f-a976-394ac6372bea/documents/IUC5-f9b3ce92-e3e8-4bbb-beb5-eae2f801efc0_bf0e2d70-745d-41f5-9550-81fe63e0769b.html,,,,,, "2-Acetone, polymer with phenol",35238-34-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/374d9a8e-757c-445f-a976-394ac6372bea/documents/IUC5-f9b3ce92-e3e8-4bbb-beb5-eae2f801efc0_bf0e2d70-745d-41f5-9550-81fe63e0769b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,37 mg/kg bw/day,,rat 2-allyloxymethyl-2-ethylpropanediol,682-11-1,"A NOEL of 40 mg/kg bw/day was determined for the sub-acute repeated dose oral toxicity of 2-allyloxymethyl-2-ethylpropanediol in a 28-day study, based on clinical signs (hypoactivity). Based on existing datasets and structural and chemical considerations, read-across from 2-allyloxymethyl-2-ethylpropanediol to a sub-chronic repeated dose toxicity studty on 2,2-bis(allyloxymethyl)butan-1-ol is appropriate to meet the REACH Annex VII-IX data requirements. The NOAEL for the sub-chronic (90 day) repeated dose toxicity of 2,2-bis(allyloxymethyl)butan-1-ol was determined to be 200 mg/kg bw/day, based on observations of liver weight change and possible adaptive effects on other liver parameters, in conjunction with bodyweight changes and adverse clinical observations at the highest dose level. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bae52220-3b58-41fa-b688-fd89472ddf47/documents/IUC5-ab71dcbb-dda4-4c5a-857c-68ca95b440ca_a424af44-1ae2-4cdd-8332-e2d3cabce82b.html,,,,,, 2-allyloxymethyl-2-ethylpropanediol,682-11-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bae52220-3b58-41fa-b688-fd89472ddf47/documents/IUC5-ab71dcbb-dda4-4c5a-857c-68ca95b440ca_a424af44-1ae2-4cdd-8332-e2d3cabce82b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat 2-allyloxymethyl-2-ethylpropanediol,682-11-1,The acute oral and dermal toxicity of 2-allyloxymethyl-2-ethylpropanediol is low. The oral LD50 of the substance in the rat is 4930 mg/kg bw. The dermal LD50 of the substance in the rabbit is > 15800 mg/kg bw. A waiver is proposed in accordance with Column 2 of Annex VIII of the REACH Regulation for acute inhalation toxicity on the basis that acute toxicity data are available for the oral and dermal routes. Inhalation is not predicted to be a significant route of exposure based on the physicochemical properties of the substance. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bae52220-3b58-41fa-b688-fd89472ddf47/documents/IUC5-029194b5-291f-427d-afbd-822beff6ccab_a424af44-1ae2-4cdd-8332-e2d3cabce82b.html,,,,,, 2-allyloxymethyl-2-ethylpropanediol,682-11-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bae52220-3b58-41fa-b688-fd89472ddf47/documents/IUC5-029194b5-291f-427d-afbd-822beff6ccab_a424af44-1ae2-4cdd-8332-e2d3cabce82b.html,,oral,LD50,"4,930 mg/kg bw",adverse effect observed, 2-allyloxymethyl-2-ethylpropanediol,682-11-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bae52220-3b58-41fa-b688-fd89472ddf47/documents/IUC5-029194b5-291f-427d-afbd-822beff6ccab_a424af44-1ae2-4cdd-8332-e2d3cabce82b.html,,dermal,LD50,"15,800 mg/kg bw",no adverse effect observed, 2-amino-2'-chloro-5-nitrobenzophenone,2011-66-7,  Evaluation of Acute Oral (Gavage) Toxicity with ACN in Rats - 12/12/2005 _  KBL/2005/1516 Rpo ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/416dfdb8-7cd3-4088-a7be-611920a9476c/documents/28118b58-7906-4f34-83e7-c6b191ffe649_893a7f64-91a7-4beb-87f6-a41c8abc82fa.html,,,,,, 2-amino-2'-chloro-5-nitrobenzophenone,2011-66-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/416dfdb8-7cd3-4088-a7be-611920a9476c/documents/28118b58-7906-4f34-83e7-c6b191ffe649_893a7f64-91a7-4beb-87f6-a41c8abc82fa.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-amino-3,5-xylenesulphonic acid",88-22-2," Acute oral toxicity: LD50 was estimated to be 1728 mg/kg bw when Sprague-Dawley male and female rats were orally exposed with 2-amino-3,5-dimethylbenzene-1-sulfonic acid. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4096d6da-8842-46f0-9f1f-813b6c08e2ca/documents/889ea13b-cde8-4695-9ed6-784e2579109a_a2370b9c-7a4a-45eb-b7b3-c4106a213f4d.html,,,,,, "2-amino-3,5-xylenesulphonic acid",88-22-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4096d6da-8842-46f0-9f1f-813b6c08e2ca/documents/889ea13b-cde8-4695-9ed6-784e2579109a_a2370b9c-7a4a-45eb-b7b3-c4106a213f4d.html,,oral,LD50,"1,728 mg/kg bw",adverse effect observed, 2-amino-5-(2-hydroxyethyl)-6-methyl-4(3H)-pyrimidinone,6940-45-0," The test item SP02 (trade name: 5OHMIC) administered to 6 females at a limit dose of 2000 mg/kg body weight did not cause death. No signs of toxicity were observed during the first 4 hours in females or the 14-day observation period thereafter. The body weights of all animals were increasing during the study. No body weight losses were observed between the first and second week after administration of the test item. During necropsy, no macroscopic findings were observed. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e23bf98a-ca09-4deb-bcb2-ffce4778c612/documents/b4ff6923-1bbd-4122-83e7-dcb5a17b1268_0f0bc6ac-a019-492f-852a-42d6a8c94e2f.html,,,,,, 2-amino-5-bromopyridin-3-ol,39903-01-0,"A 7-day repeated dose study (Beerens - Heijnen, 2011) is available which is key study. This study showed that the test substance has no toxic potential when administered at 600 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09eaa6bc-b6aa-4263-b3f1-34eb5f7aa724/documents/IUC5-4fa219b8-544e-4e32-a4a3-8f2222ee66ed_f51c740c-6482-44a6-9d6a-c9f917642f58.html,,,,,, 2-amino-5-bromopyridin-3-ol,39903-01-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09eaa6bc-b6aa-4263-b3f1-34eb5f7aa724/documents/IUC5-4fa219b8-544e-4e32-a4a3-8f2222ee66ed_f51c740c-6482-44a6-9d6a-c9f917642f58.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat 2-amino-5-bromopyridin-3-ol,39903-01-0,"Acute oral toxicity: A primary oral toxicity study (Beerens-Heijnen, 2010) was available which is key study. This study showed that the oral LD50 value of test substance is established to exceed 2000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09eaa6bc-b6aa-4263-b3f1-34eb5f7aa724/documents/IUC5-d96e73be-046c-409d-baa1-38b39831feaf_f51c740c-6482-44a6-9d6a-c9f917642f58.html,,,,,, 2-amino-5-bromopyridin-3-ol,39903-01-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09eaa6bc-b6aa-4263-b3f1-34eb5f7aa724/documents/IUC5-d96e73be-046c-409d-baa1-38b39831feaf_f51c740c-6482-44a6-9d6a-c9f917642f58.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-amino-5-chlorobenzenesulphonic acid,133-74-4, Acute oral toxicity is >2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ed2e465-d7e4-42c1-bf06-724208ebfe76/documents/a21f9aa4-42f8-4843-a232-87c89c320b34_035b7892-4764-4a23-aba9-6306610f4091.html,,,,,, 2-amino-5-chlorobenzenesulphonic acid,133-74-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ed2e465-d7e4-42c1-bf06-724208ebfe76/documents/a21f9aa4-42f8-4843-a232-87c89c320b34_035b7892-4764-4a23-aba9-6306610f4091.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Amino-5-Chloro-N,3-Dimethylbenzamide",890707-28-5," In an acute oral toxicity study according to OECD 425 in female Wistar rats, the toxicological profile of 2 -amino-5 -chloro-N,3 -dimethylbenzamide was assessed and the median lethal dose determined to LD50 = 310.2 mg/Kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0646c8b-39d1-475a-accf-08e23902c9d8/documents/8037e441-458b-4043-b759-055704ce352b_0e5de4e2-74e6-4a85-b525-bd861b25e2bc.html,,,,,, "2-Amino-5-Chloro-N,3-Dimethylbenzamide",890707-28-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0646c8b-39d1-475a-accf-08e23902c9d8/documents/8037e441-458b-4043-b759-055704ce352b_0e5de4e2-74e6-4a85-b525-bd861b25e2bc.html,,oral,LD50,310.2 mg/kg bw,adverse effect observed, "2-amino-5-hydroxynaphthalene-1,7-disulphonic acid",6535-70-2, The LD50 was estimated to be 3199 mg/kg bw for rats.  ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c66f1e7-a72f-4520-b66d-7a19418267a2/documents/bcf51a08-79f6-4ae5-a1df-fe0511a51276_6cc1d297-8277-4e8e-ae17-32bb07d347ce.html,,,,,, "2-amino-5-hydroxynaphthalene-1,7-disulphonic acid",6535-70-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c66f1e7-a72f-4520-b66d-7a19418267a2/documents/bcf51a08-79f6-4ae5-a1df-fe0511a51276_6cc1d297-8277-4e8e-ae17-32bb07d347ce.html,,oral,LD50,"3,199 mg/kg bw",no adverse effect observed, "2-amino-6-methyl-4-propyl-1,2,4-triazolo[1,5-a]pyrimidin-5(4H)-one",27277-00-5," Oral: Discriminating dose = 1.5 mg/kg bw/day, male, beagles, pre-guideline study, Farrell 1970 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7767fd8-0ee5-4bb1-98a0-b1f84a9a290a/documents/08557309-5cc2-49e5-9ea4-49033491f944_e1f9829b-2f2d-4550-aa0b-70e5b22bc4f8.html,,,,,, "2-amino-6-methyl-4-propyl-1,2,4-triazolo[1,5-a]pyrimidin-5(4H)-one",27277-00-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7767fd8-0ee5-4bb1-98a0-b1f84a9a290a/documents/08557309-5cc2-49e5-9ea4-49033491f944_e1f9829b-2f2d-4550-aa0b-70e5b22bc4f8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,1.5 mg/kg bw/day,,dog "2-amino-6-methyl-4-propyl-1,2,4-triazolo[1,5-a]pyrimidin-5(4H)-one",27277-00-5," Oral: Discriminating dose = 100 mg/kg bw, male, Macaca fascicularis, pre-guideline study, Purser 1978 Dermal: Discriminating dose = 2000 mg/kg bw, male/female, rat, pre-guideline study, Davison 1988 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7767fd8-0ee5-4bb1-98a0-b1f84a9a290a/documents/858d7d59-8ae3-4753-aa47-d6747d85a3ba_e1f9829b-2f2d-4550-aa0b-70e5b22bc4f8.html,,,,,, "2-amino-6-methyl-4-propyl-1,2,4-triazolo[1,5-a]pyrimidin-5(4H)-one",27277-00-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7767fd8-0ee5-4bb1-98a0-b1f84a9a290a/documents/858d7d59-8ae3-4753-aa47-d6747d85a3ba_e1f9829b-2f2d-4550-aa0b-70e5b22bc4f8.html,,oral,discriminating dose,100 mg/kg bw,no adverse effect observed, "2-amino-6-methyl-4-propyl-1,2,4-triazolo[1,5-a]pyrimidin-5(4H)-one",27277-00-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7767fd8-0ee5-4bb1-98a0-b1f84a9a290a/documents/858d7d59-8ae3-4753-aa47-d6747d85a3ba_e1f9829b-2f2d-4550-aa0b-70e5b22bc4f8.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-Aminoethanol reaction products with cyclohexane and peroxidized N-butyl-2,2,6,6-tetramethyl-4-piperidinamine-2,4,6-trichloro-1,3,5-triazine reaction products",191743-75-6," Male and female reats were administered to 50, 250 and 1000 mg/kg bw of the test item for 28 days followed by a treatment free period of 14 days (OECD guideline 407, GLP). Teh substance did not cause clinical signs or adverse effects. The NOAEL is therefore considered to be 1000 mg/kg bw. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67895ce3-19e7-4242-ae0c-52e0eb3586aa/documents/5ae70bf3-bf3e-499c-b8f8-3f71d2f3f9d1_8270c17f-270b-48e0-8406-db23ae0e34ad.html,,,,,, "2-Aminoethanol reaction products with cyclohexane and peroxidized N-butyl-2,2,6,6-tetramethyl-4-piperidinamine-2,4,6-trichloro-1,3,5-triazine reaction products",191743-75-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67895ce3-19e7-4242-ae0c-52e0eb3586aa/documents/5ae70bf3-bf3e-499c-b8f8-3f71d2f3f9d1_8270c17f-270b-48e0-8406-db23ae0e34ad.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-Aminoethanol reaction products with cyclohexane and peroxidized N-butyl-2,2,6,6-tetramethyl-4-piperidinamine-2,4,6-trichloro-1,3,5-triazine reaction products",191743-75-6," Single oral and dermal application of the test item to male and female rats (OECD guideline 401 and 402, GLP) did not induce treatment related mortality or symptoms of toxicity. The LD50 after oral administration is therefore considered to > 5000 mg/kg bw and > 2000 mg/kg bw after dermal application. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67895ce3-19e7-4242-ae0c-52e0eb3586aa/documents/469cfd8f-eb1e-4057-b061-f38be09dcf1b_8270c17f-270b-48e0-8406-db23ae0e34ad.html,,,,,, "2-Aminoethanol reaction products with cyclohexane and peroxidized N-butyl-2,2,6,6-tetramethyl-4-piperidinamine-2,4,6-trichloro-1,3,5-triazine reaction products",191743-75-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67895ce3-19e7-4242-ae0c-52e0eb3586aa/documents/469cfd8f-eb1e-4057-b061-f38be09dcf1b_8270c17f-270b-48e0-8406-db23ae0e34ad.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-Aminoethanol reaction products with cyclohexane and peroxidized N-butyl-2,2,6,6-tetramethyl-4-piperidinamine-2,4,6-trichloro-1,3,5-triazine reaction products",191743-75-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67895ce3-19e7-4242-ae0c-52e0eb3586aa/documents/469cfd8f-eb1e-4057-b061-f38be09dcf1b_8270c17f-270b-48e0-8406-db23ae0e34ad.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-aminoethyldiethylamine,100-36-7,"Oral LD50 (rat): 984 mg/kg bw (BASF 1980, equivalent or similar to OECD 401) Inhalation LC50 (rat): > 2.9 mg/L air (aerosol, 4h, BASF 1978), 20 - 26 mg/L (vapour, 3h, BASF 1980 + 1969)Dermal LD50 (rabbit): > 200 mg/kg bw (BASF 1978, equivalent or similar to OECD 402), 672 mg/kg (Patty 1962, secondary source) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Estimated Klimisch Rating: 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Estimated Klimisch Rating: 2 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46c90e03-0a51-4192-987a-86fe5950404d/documents/IUC5-e73d1e23-a6d2-4aa0-955d-7fa116c68642_6e18c6eb-ae2e-409b-8a56-dd82a28d18c6.html,,,,,, 2-aminoethyldiethylamine,100-36-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46c90e03-0a51-4192-987a-86fe5950404d/documents/IUC5-e73d1e23-a6d2-4aa0-955d-7fa116c68642_6e18c6eb-ae2e-409b-8a56-dd82a28d18c6.html,,oral,LD50,984 mg/kg bw,adverse effect observed, 2-aminoethyldiethylamine,100-36-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46c90e03-0a51-4192-987a-86fe5950404d/documents/IUC5-e73d1e23-a6d2-4aa0-955d-7fa116c68642_6e18c6eb-ae2e-409b-8a56-dd82a28d18c6.html,,dermal,LD50,672 mg/kg bw,adverse effect observed, "2-aminopropane-1,3-diol",534-03-2,"Oral (OECD 408), 90 -day in rats: NOAEL (systemic) ≥ 1000 mg/kg bw/d ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5eba2bf1-3605-4411-8726-b69c6bbb2e07/documents/IUC5-65e032c0-24dc-400a-a6c8-e980c00547be_459b6676-dfb7-4323-b1c6-c80692ffe75f.html,,,,,, "2-aminopropane-1,3-diol",534-03-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5eba2bf1-3605-4411-8726-b69c6bbb2e07/documents/IUC5-65e032c0-24dc-400a-a6c8-e980c00547be_459b6676-dfb7-4323-b1c6-c80692ffe75f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-aminopropane-1,3-diol",534-03-2,"Oral (TSCA, 40 CFR, 798.1175), rat: LD50 = 5000 mg/kg bw Dermal (TSCA, 40 CFR, 798.1100) , rat: LD50 > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5eba2bf1-3605-4411-8726-b69c6bbb2e07/documents/IUC5-f06030d7-a55c-4754-86eb-41b1017b93e7_459b6676-dfb7-4323-b1c6-c80692ffe75f.html,,,,,, "2-aminopropane-1,3-diol",534-03-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5eba2bf1-3605-4411-8726-b69c6bbb2e07/documents/IUC5-f06030d7-a55c-4754-86eb-41b1017b93e7_459b6676-dfb7-4323-b1c6-c80692ffe75f.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-aminotoluene-4-sulphonic acid,618-03-1," Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for 2-aminotoluene-4-sulphonic acid. The study assumed the use of male and female Sprague Dawley rats in a 18 days toxicity study. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Level (NOAEL) for 2-aminotoluene-4-sulphonic acid is predicted to be 948.0 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/61b3d90b-89b0-4221-8856-2f64ef5ea122/documents/2633b1fb-4ed6-4757-95a8-06ef4215b630_0894dc57-7aac-46df-8a6a-a0eb869675ef.html,,,,,, 2-aminotoluene-4-sulphonic acid,618-03-1,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/61b3d90b-89b0-4221-8856-2f64ef5ea122/documents/2633b1fb-4ed6-4757-95a8-06ef4215b630_0894dc57-7aac-46df-8a6a-a0eb869675ef.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,948 mg/kg bw/day,,rat 2-aminotoluene-4-sulphonic acid,618-03-1," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target substance 2-aminotoluene-4-sulphonic acid (618-03-7) was estimated to be 2307.95 mg/kg bw,and the QSAR prediction done using the Danish (Q)SAR Databasefor target substance 2-aminotoluene-4-sulphonic acid (618-03-7) was estimated to be 3100 mg/kg bw, and for differentstudies available on the structurally similar read across substance 6-aminonaphthalene-2-sulphonic acid (93-00-5) was considered to be 5000 mg/kg bw, for 4-aminotoluene-3-sulphonic acid(88-44-8) was considered to be 12000 mg/kg bw and for 1,3-Phenylenediamine-4-sulfonic acid(88-63-1) was considered to be 3480 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,2-aminotoluene-4-sulphonic acid (618-03-7) cannot be classified for acute oral toxicity. Acute Inhalation Toxicity:  2-aminotoluene-4-sulphonic acid (618-03-7) has very low vapor pressure (9.43E-006 Pa.).So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver. Acute Dermal Toxicity: In Acute dermal toxicity, LD50 value was predicted based on OECD QSAR toolbox for target substance 2-aminotoluene-4-sulphonic acid (618-03-7) was estimated to be 2152.55 mg/kg bw ,and for differentstudies available on structurally similar read across substance 6-aminonaphthalene-2-sulphonic acid (93-00-5) was considered to be >2000 mg/kg bw.All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-aminotoluene-4-sulphonic acid (618-03-7) cannot be classified for acute dermal toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61b3d90b-89b0-4221-8856-2f64ef5ea122/documents/fbef2ac9-06d4-46e4-b5cd-dc6cefca873c_0894dc57-7aac-46df-8a6a-a0eb869675ef.html,,,,,, 2-aminotoluene-4-sulphonic acid,618-03-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61b3d90b-89b0-4221-8856-2f64ef5ea122/documents/fbef2ac9-06d4-46e4-b5cd-dc6cefca873c_0894dc57-7aac-46df-8a6a-a0eb869675ef.html,,oral,LD50,"2,307.95 mg/kg bw",no adverse effect observed, 2-aminotoluene-4-sulphonic acid,618-03-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61b3d90b-89b0-4221-8856-2f64ef5ea122/documents/fbef2ac9-06d4-46e4-b5cd-dc6cefca873c_0894dc57-7aac-46df-8a6a-a0eb869675ef.html,,dermal,LD50,"2,152.55 mg/kg bw",, "2'-anilino-6'-[ethyl(3-methylbutyl)amino]-3'-methylspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one",70516-41-5,"Cortical tubular basophilia was evident in the kidneys of females given S-205 at 1000 mg/kg/day. Under the conditions of this study, this was not considered to be adverse as the changes were predominantly minimal, occurred unilaterally in the majority of animals and were without a correlate. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9b33678-7495-4499-a9ab-df29b8d6b1dc/documents/IUC5-8f0b20f3-d9a4-47fa-9ab8-5aa0b9ec2df6_a3f9c3ff-2fea-44a0-9cdd-1e96089daa8f.html,,,,,, "2'-anilino-6'-[ethyl(3-methylbutyl)amino]-3'-methylspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one",70516-41-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9b33678-7495-4499-a9ab-df29b8d6b1dc/documents/IUC5-8f0b20f3-d9a4-47fa-9ab8-5aa0b9ec2df6_a3f9c3ff-2fea-44a0-9cdd-1e96089daa8f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2'-anilino-6'-[ethyl(3-methylbutyl)amino]-3'-methylspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one",70516-41-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study cannot be considered reliable without restrictions, as it does not include a formal claim of GLP compliance, nor was it conducted in accordance with official test guidelines (it should be noted that such guidelines, and official GLP guidelines were not available at the time when the study was conducted). The study does contain a statement of Quality Assurance, and is generally well documented; in addition, the methodology employed is largely consistent with modern methodology for the assessment of acute oral toxicity, and on this basis the study is considered reliable (with restrictions). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Study undertaken at GLP accredited laboratory to internationally accepted guidelines. The restriction is due to the use of the read across approach: the test was performed not with S-205 but with Black 400, a substance which has been demonstrated to be very similar in structure, physical/chemical properties and the toxicological profile. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9b33678-7495-4499-a9ab-df29b8d6b1dc/documents/IUC5-dfcd2941-51e5-40c5-b44c-fee303e27e91_a3f9c3ff-2fea-44a0-9cdd-1e96089daa8f.html,,,,,, "2'-anilino-6'-[ethyl(3-methylbutyl)amino]-3'-methylspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one",70516-41-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9b33678-7495-4499-a9ab-df29b8d6b1dc/documents/IUC5-dfcd2941-51e5-40c5-b44c-fee303e27e91_a3f9c3ff-2fea-44a0-9cdd-1e96089daa8f.html,,oral,LD50,"16,000 mg/kg bw",no adverse effect observed, "2'-anilino-6'-[ethyl(3-methylbutyl)amino]-3'-methylspiro[isobenzofuran-1(3H),9'-[9H]xanthene]-3-one",70516-41-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9b33678-7495-4499-a9ab-df29b8d6b1dc/documents/IUC5-dfcd2941-51e5-40c5-b44c-fee303e27e91_a3f9c3ff-2fea-44a0-9cdd-1e96089daa8f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-anilinoethanol,122-98-5,No information on relevant exposure routes regarding repeated dose toxicity are available. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7a2be7e-4c13-4ead-817a-ef1f46ef35e6/documents/IUC5-ae5093f5-19cc-496d-9a90-0e7169223635_085436ea-dec9-457e-9280-5674c9103c69.html,,,,,, 2-anilinoethanol,122-98-5,The oral LD50 was determined to be > 55 mg/kg.The inhalation LC50 could not be determined.The dermal LD50 was determined to be 68.7 mg/kg. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7a2be7e-4c13-4ead-817a-ef1f46ef35e6/documents/IUC5-2e9b1905-b50b-418e-97a2-f0f74efc7382_085436ea-dec9-457e-9280-5674c9103c69.html,,,,,, 2-anilinoethanol,122-98-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7a2be7e-4c13-4ead-817a-ef1f46ef35e6/documents/IUC5-2e9b1905-b50b-418e-97a2-f0f74efc7382_085436ea-dec9-457e-9280-5674c9103c69.html,,dermal,LD50,68.7 mg/kg bw,adverse effect observed, 2-benzoylbenzoic acid,85-52-9, Studies performed under GLP conditions. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/897952fe-391b-410c-a8fe-c2f7e0a5957a/documents/00ff78b2-fe26-424b-a660-e1b9fbdbc135_2b7c0fb9-fea8-4fcb-8c89-108ffe76fc51.html,,,,,, 2-benzoylbenzoic acid,85-52-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/897952fe-391b-410c-a8fe-c2f7e0a5957a/documents/00ff78b2-fe26-424b-a660-e1b9fbdbc135_2b7c0fb9-fea8-4fcb-8c89-108ffe76fc51.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-benzoylbenzoic acid,85-52-9, OECD 402 Study performed to recognised testing guidelines with GLP certification. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/897952fe-391b-410c-a8fe-c2f7e0a5957a/documents/6be972d5-4c4a-48ec-8302-210a8b63c4c5_2b7c0fb9-fea8-4fcb-8c89-108ffe76fc51.html,,,,,, 2-benzoylbenzoic acid,85-52-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/897952fe-391b-410c-a8fe-c2f7e0a5957a/documents/6be972d5-4c4a-48ec-8302-210a8b63c4c5_2b7c0fb9-fea8-4fcb-8c89-108ffe76fc51.html,,oral,LD50,"4,600 mg/kg bw",no adverse effect observed, 2-benzoylbenzoic acid,85-52-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/897952fe-391b-410c-a8fe-c2f7e0a5957a/documents/6be972d5-4c4a-48ec-8302-210a8b63c4c5_2b7c0fb9-fea8-4fcb-8c89-108ffe76fc51.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-bromo-2-methylpropionyl bromide,20769-85-1,Isopropyl 2-bromoisobutyrate has to be considered as harmful if swallowed since an acute oral toxicity test showed a mortality rate in rats from 300 to 500 mg/kg bodyweight. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6cd9e9b3-511b-4633-95e2-14b68ca0a736/documents/IUC5-2f4255cb-87aa-47af-bbb6-d1bf654c4c46_a9e60cd8-0c7e-4c80-900a-7362d88373e1.html,,,,,, 2-bromo-2-methylpropionyl bromide,20769-85-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6cd9e9b3-511b-4633-95e2-14b68ca0a736/documents/IUC5-2f4255cb-87aa-47af-bbb6-d1bf654c4c46_a9e60cd8-0c7e-4c80-900a-7362d88373e1.html,,oral,LD50,300 mg/kg bw,, 2-bromobenzonitrile,2042-37-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Source1: data from Supplier (Test method OECD 423) Source2: Journal of Medicinal Chemistry. Vol. 21, Pg. 906, 1978 Reliability 2 LD50 oral mouse > 300 mg/kg bw Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): LD50 rat: 1200 mg/kg bw Source: Aerospace Medical Research Laboratory Report. Vol. TR-74-78, Pg. 1974 LD50 rabbit: 1250 mg/kg bw Food and Cosmetics Toxicology. Vol. 17, Pg. 723, 1979. Experimental data on the similar substance Bromobenzonitrile CAS 100-47-0 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea003ad9-1188-474e-bed3-8ea13b381fee/documents/45a76159-0b62-4884-b2b9-b41d42fc0abe_5f47b836-ae0a-4e5b-b4e6-7157b9214b58.html,,,,,, 2-bromobenzonitrile,2042-37-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea003ad9-1188-474e-bed3-8ea13b381fee/documents/45a76159-0b62-4884-b2b9-b41d42fc0abe_5f47b836-ae0a-4e5b-b4e6-7157b9214b58.html,,oral,LD50,> 200 mg/kg bw,adverse effect observed, 2-bromobenzonitrile,2042-37-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea003ad9-1188-474e-bed3-8ea13b381fee/documents/45a76159-0b62-4884-b2b9-b41d42fc0abe_5f47b836-ae0a-4e5b-b4e6-7157b9214b58.html,,dermal,LD50,"1,200 mg/kg bw",adverse effect observed, 2-bromoethylammonium bromide,2576-47-8, LD50 was considered to be > 1138 mg/kg bw when Deer mice were treated with 2-bromoethanaminium bromide orally by gavage.  ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8681d27b-fdd4-47fe-9396-b89393251dcc/documents/1f643b96-6353-4e72-94f9-6843aecda2d1_e4a57d21-9a17-47b0-85be-56dce455535b.html,,,,,, 2-bromoethylammonium bromide,2576-47-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8681d27b-fdd4-47fe-9396-b89393251dcc/documents/1f643b96-6353-4e72-94f9-6843aecda2d1_e4a57d21-9a17-47b0-85be-56dce455535b.html,,oral,LD50,"1,138 mg/kg bw",adverse effect observed, 2-bromopyridine,109-04-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): supplier's data Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): supplier's data ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a0f4158-3d6f-4a01-a655-dbd6bd53f597/documents/ada49630-2495-4227-a827-acd03daef7de_5334cfde-a5d9-4c28-9f15-90d608e0300d.html,,,,,, 2-bromopyridine,109-04-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a0f4158-3d6f-4a01-a655-dbd6bd53f597/documents/ada49630-2495-4227-a827-acd03daef7de_5334cfde-a5d9-4c28-9f15-90d608e0300d.html,,oral,LD50,92 mg/kg bw,, 2-bromopyridine,109-04-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a0f4158-3d6f-4a01-a655-dbd6bd53f597/documents/ada49630-2495-4227-a827-acd03daef7de_5334cfde-a5d9-4c28-9f15-90d608e0300d.html,,dermal,LD50,81.5 mg/kg bw,, "1,1,1,3,4,4,4-heptafluoro-3-(trifluoromethyl)butan-2-one",756-12-7,"Repeat-dose oral and inhalation toxicity studies have been conducted on CAS# 756-12-7. The results of the studies are: A 5 day inhalation study resulted in a repeat inhalation LC50 greater than 5,000 ppm.A 28 day inhalation study resulted in a NOAEC of 3,000 ppm ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef15c883-0c37-4a7c-abb2-c9dbb32f1cd6/documents/IUC5-ef0783f7-d876-4546-a434-8f165b0bfe01_753110d9-9403-4a7a-bb80-f710be9966e4.html,,,,,, "1,1,1,3,4,4,4-heptafluoro-3-(trifluoromethyl)butan-2-one",756-12-7," Three acute inhalation, an acute dermal and an acute oral lethality study have been conducted on CAS# 756-12-7. The results of the studies were: Oral: The acute oral LD50 was found to be greater than 2,000 mg/kg body weight when tested according to OECD 425. Inhalation: Key Study: The acute 4-hour inhalation LC50 was found to be greater than 148 but less than 213 mg/L (vapor) when tested according to OECD 403. 4-Hour LC50:  > 10000 ppm 4-Hour LC50:   20000 ppm Dermal: The acute dermal LD50 was found to be greater than 2,000 mg/kg body weight when tested according to OECD 403. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef15c883-0c37-4a7c-abb2-c9dbb32f1cd6/documents/IUC5-67646546-e9ee-4617-b08c-0f7ca5f756c8_753110d9-9403-4a7a-bb80-f710be9966e4.html,,,,,, "Reaction mass of butane-2,2-diyl dihydroperoxide and di-sec-butylhexaoxidane",1338-23-4,"Methyl-ethylketone peroxide in TXIB/diacetone alcohol was tested in a 90-day repeated dose toxicity study by oral application in rats according to EU method B.26 and OECD guideline 408. The test item was administered at 20, 50 and 150 mg/kg bw/day. A NOAEL of 150 mg/kg bw/day in males and female rats was determined. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Two repeated dose toxicity studies with the test item according to GLP and the respective OECD/EU guidelines are available. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14bce18a-e436-46a7-928a-03b92b8229f7/documents/857f4bb7-4d96-459e-ac73-000e05a7b022_be0a9392-af27-4cd2-8d7c-e8e04c37c3a8.html,,,,,, "Reaction mass of butane-2,2-diyl dihydroperoxide and di-sec-butylhexaoxidane",1338-23-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14bce18a-e436-46a7-928a-03b92b8229f7/documents/857f4bb7-4d96-459e-ac73-000e05a7b022_be0a9392-af27-4cd2-8d7c-e8e04c37c3a8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Reaction mass of butane-2,2-diyl dihydroperoxide and di-sec-butylhexaoxidane",1338-23-4,"Methyl-ethylketone peroxide was tested for acute toxicity by oral, inhalation and dermal application to the rat and mice. The LD50 (oral, male) was 1017 mg/kg bw. The LC50 (4h, inhalation) was 17 mg/L. The combined dermal LD50 was 4000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Non-GLP and non-guideline study, but sufficient for assessment. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Non-GLP and non-guideline studies, but sufficient for assessment. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Non-GLP and non-guideline study, but sufficient for assessment. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14bce18a-e436-46a7-928a-03b92b8229f7/documents/273df581-c616-4789-8650-35e01eed3444_be0a9392-af27-4cd2-8d7c-e8e04c37c3a8.html,,,,,, "Reaction mass of butane-2,2-diyl dihydroperoxide and di-sec-butylhexaoxidane",1338-23-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14bce18a-e436-46a7-928a-03b92b8229f7/documents/273df581-c616-4789-8650-35e01eed3444_be0a9392-af27-4cd2-8d7c-e8e04c37c3a8.html,,oral,LD50,"1,017 mg/kg bw",adverse effect observed, "Reaction mass of butane-2,2-diyl dihydroperoxide and di-sec-butylhexaoxidane",1338-23-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14bce18a-e436-46a7-928a-03b92b8229f7/documents/273df581-c616-4789-8650-35e01eed3444_be0a9392-af27-4cd2-8d7c-e8e04c37c3a8.html,,dermal,LD50,"4,000 mg/kg bw",adverse effect observed, "Reaction mass of butane-2,2-diyl dihydroperoxide and di-sec-butylhexaoxidane",1338-23-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14bce18a-e436-46a7-928a-03b92b8229f7/documents/273df581-c616-4789-8650-35e01eed3444_be0a9392-af27-4cd2-8d7c-e8e04c37c3a8.html,,inhalation,LC50,"17,000 mg/m3",adverse effect observed, Phenyl(methylethylketoxime)silane,34036-80-1,"Key study: Test method EEC B7, OECD 407. GLP study. Based on the observation of a dose-related regenerative anemia in the 150 and 300 mg/kg/day males and females the NOAEL following 28-day oral administration of test substance to rats.Key study: Based on the read-across approach from experimental results on analogue butanone oxime, the NOAEL for 13 weeks repeated dose toxicity by oral route in rats was estimated to be 433.93 ppm (34.77 and 41.72 mg/kg bw/day for males and females respectively).Supporting study: Based on the read-across approach from experimental results on analogue butanone oxime, the NOAEL for 13 weeks repeated dose toxicity by oral route in mice was estimated to be 869 ppm (152.99 mg/kg bw/day) for males and 1738.50 ppm (472.87 mg/kg bw/day) for females. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6487d97a-1b0d-47d8-8185-90b4893963a5/documents/IUC5-54cacc67-0705-426e-9575-bb089490d82e_3520aadd-86cc-4995-997d-e2c8b4be087e.html,,,,,, Phenyl(methylethylketoxime)silane,34036-80-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6487d97a-1b0d-47d8-8185-90b4893963a5/documents/IUC5-54cacc67-0705-426e-9575-bb089490d82e_3520aadd-86cc-4995-997d-e2c8b4be087e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,34.77 mg/kg bw/day,,rat Phenyl(methylethylketoxime)silane,34036-80-1,"Acute toxicity, oral. Key study: Test method EPA OTS 798.1175 (similar to OECD guideline 401). GLP study. The acute oral LD50 in the rat was determined to be greater than 2000 mglkg. The 100 mg/kg dose group was considered to be NOAEL since toxicity was observed in rats dosed at 2000 mg/kg and 500 mg/kg as expressed by adverse clinical signs and significant body weight decreases. Acute toxicity, dermal: Key study: Test method EEC B3, OECD 402. GLP study. The acute lethal dermal dose to rats was demonstrated to be greater than 2000 mg/kg bodyweight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6487d97a-1b0d-47d8-8185-90b4893963a5/documents/IUC5-435accea-a700-4d4c-a20e-882877ad0807_3520aadd-86cc-4995-997d-e2c8b4be087e.html,,,,,, Phenyl(methylethylketoxime)silane,34036-80-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6487d97a-1b0d-47d8-8185-90b4893963a5/documents/IUC5-435accea-a700-4d4c-a20e-882877ad0807_3520aadd-86cc-4995-997d-e2c8b4be087e.html,,oral,LD50,"2,001 mg/kg bw",no adverse effect observed, Phenyl(methylethylketoxime)silane,34036-80-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6487d97a-1b0d-47d8-8185-90b4893963a5/documents/IUC5-435accea-a700-4d4c-a20e-882877ad0807_3520aadd-86cc-4995-997d-e2c8b4be087e.html,,dermal,LD50,"2,001 mg/kg bw",no adverse effect observed, "(E)-2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol",106155-02-6," Read across from a structural analogue or surrogate ((2E)-2-ethyl-4-(2,2,3-trimethyl-3-cyclopenten-1-yl)-buten-1-ol, CAS 106185-75-5) was used to fulfil this endpoint. The repeated dose toxicity of the substance was assessed according to OECD Guideline 422. Three groups, each comprising of ten male and ten female rats for the Main (reproductive) phase and five female rats for the Toxicity phase received the test item at doses of 100, 300 or 1000 mg/kg/day at a dose volume of 5 mL/kg/day. Main phase males and Toxicity phase females were dosed daily for a minimum of five consecutive weeks. An additional five males and five females were dosed with the vehicle or at 1000 mg/kg/day for five weeks and then given two weeks of recovery before termination. Main phase females were dosed daily for two weeks before pairing, throughout mating, gestation and until Day 6 of lactation. A similarly constituted Control group received the vehicle, corn oil, at the same volume-dose. During the study, data was recorded on clinical condition, performance under detailed physical and arena examination, sensory reactivity, grip strength, motor activity, bodyweight, food consumption, water consumption (visual), haematology, blood chemistry, oestrous cycles, mating performance and fertility and gestation length. Organ weight, macroscopic and microscopic pathology investigations were undertaken in the adults. The clinical condition of offspring, litter size and survival, sex ratio and offspring bodyweight were assessed and macroscopic pathology investigations were undertaken. In the 1000 mg/kg/day dose group, four females allocated to the littering phase of this study were killed prior to scheduled termination. Two females were killed in late gestation following deterioration in clinical condition. The females showed signs including irregular breathing, reduced activity, hunched posture and dull/pale/partially closed eyes. Both females were pregnant with a live and normal litter. A further female was killed during parturition with similar signs, plus limited use of limbs and reduced body tone: most pups had died and the three that remained were killed at the same time as the dam. The fourth female was killed on Day 1 of lactation due to high levels of pup mortality on Day 1 of lactation. The condition of the litter was poor with small, cold pups that did not appear to be feeding. The macroscopic findings at necropsy were unremarkable for all four dams. No significant findings were recorded for clinical signs, detailed physical examination and arena observations. Underactive behaviour in males and females and unsteady posture in females were observed briefly during Week 1 in animals at 1000 mg/kg/day and dose related increases in post dosing salivation and chin rubbing were seen. Behavioural testing during Week 5 of dosing, including sensory reactivity findings, grip strength values and motor activity scores showed no differences considered to be associated with test material. During late gestation females receiving 1000 mg/kg/day showed significantly lower weight gain than Controls but bodyweight and bodyweight gain were unaffected during lactation. Females receiving 1000 mg/kg/day showed lower food consumption during late gestation (Days 14-19) corresponding with the period of lower bodyweight gain. Food consumption during lactation was not significantly affected. There was no effect on oestrous cycles, precoital interval, mating performance or fertility. All females mated and were pregnant but at 1000 mg/kg/day there was evidence of increased sensitivity in late gestation: two females had to be terminated before giving birth and one female was terminated during parturition, leading to a reduction in the gestation index. Gestation length was within normal range but there was a slight increase in the numbers of animals having longer (23 day) gestation periods. All animals in the Control, 100 and 300 mg/kg/day groups gave birth to a live litter. There was no effect of test material on the number of implantations but at 1000 mg/kg/day post implantation survival index, live birth index and viability index were all lower than Control so that live litter size was smaller. Lactation index assessed on Day 7 of lactation was unaffected. There was no effect at dose levels of 300 mg/kg/day or below. Male and female offspring bodyweights were not adversely affected. Among the Toxicity subgroup animals, males receiving 1000 mg/kg/day showed lower overall weight gain (Week 0-5) compared with Control. Bodyweight during the recovery phase was similar to controls. Liver weights were higher in males and females receiving 300 or 1000 mg/kg/day and kidney weights were higher than Control in females at 1000 mg/kg/day. Organ weight measurement two weeks after the end of the dosing period showed that the effects had been reversed and organs were normal size.  Biochemical changes in females at 1000 mg/kg/day, such as increased alanine aminophosphatase, alanine aminotransferase, cholesterol and bilirubin levels also suggest that the metabolic function of the liver may have been altered by administration of the test item. All the above discussed parameters showed complete recovery after 2 weeks. Therefore, the No-Observed-Adverse-Effect-Level (NOAEL) for males and unmated females was 300 mg/k/g/day, the NOAEL for maternal toxicity was 300 mg/kg/day and the NOAEL for reproduction/developmental toxicity was at least 300 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab34efd4-4080-427f-bbf3-630ad97126cd/documents/ac9bb1a3-4497-4ea0-be44-059099a2fa4e_bdbd5dbd-e591-447c-b7bd-c94706d33cff.html,,,,,, "(E)-2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol",106155-02-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab34efd4-4080-427f-bbf3-630ad97126cd/documents/ac9bb1a3-4497-4ea0-be44-059099a2fa4e_bdbd5dbd-e591-447c-b7bd-c94706d33cff.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "(E)-2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol",106155-02-6," Acute oral toxicity The acute oral toxicity in rats was determined according to the method recommended in OECD Guidelines 420 ""Fixed dose method"" from 1992. The study was initiated with a sighting study. On the basis of the results of the sighting study, it was decided to carry out main study with dose of 5000 mg /Kg bw with a group of 10 animals. Eight animals of the main study survived the treatment and showed moderate signs of toxicity Under the experimental conditions described, the oral LD50 of the test item in rats was found to be >5000 mg/Kg bw A supporting study where one group of rats (5 males and 5 females) received 1 oral dose of Sandalmysore Core at 5000 mg/Kg bw was also used to assess acute oral toxicity. Macroscopic examination of all animals at the end of the study revealed no test substance related gross abnormalities. Macroscopic examination of one female found dead showed a yellowish intestinal content. Since only 1 animal died, the LD50 value for males and females combined was estimated to exceed 5.0 g/kg bodyweight. Acute dermal toxicity The acute dermal toxicity of the substance was assessed according to OECD 402. One group of Wistar rats, comprising 5 males and 5 females, was treated with a single dermal dose of the test item at 2000 mg/kg bodyweight for 24 hours. No mortalities occurred and no signs of systemic toxicity were observed during exposure and the following 14 -day observation period. The treated skin surface of the animals showed areas with erythema and scales. These lesions disappeared during the second week of observation. Macroscopic examination of all animals at the end of the study revealed no test substance related gross abnormalities. Since no mortalities occurred, the LD50 value for males and females combined was estimated to exceed 2.0 g/body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab34efd4-4080-427f-bbf3-630ad97126cd/documents/d1a12c40-44c0-411c-a4c5-b4a0a2b754e0_bdbd5dbd-e591-447c-b7bd-c94706d33cff.html,,,,,, "(E)-2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol",106155-02-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab34efd4-4080-427f-bbf3-630ad97126cd/documents/d1a12c40-44c0-411c-a4c5-b4a0a2b754e0_bdbd5dbd-e591-447c-b7bd-c94706d33cff.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "(E)-2-methyl-4-(2,2,3-trimethylcyclopent-3-en-1-yl)but-2-en-1-ol",106155-02-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab34efd4-4080-427f-bbf3-630ad97126cd/documents/d1a12c40-44c0-411c-a4c5-b4a0a2b754e0_bdbd5dbd-e591-447c-b7bd-c94706d33cff.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-butene,107-01-7, Members of the butenes category are flammable gases at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. Members of the butenes category have low sub-chronic toxicity. Inhalation exposure is the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies of up to 2 years in rats or mice. Nasal lesions were observed in 2 year rodent studies at the highest concentration but are considered to be a non-adverse adaptation to chronic exposure to a hydrocarbon. Members of the butenes category are flammable gases at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. Members of the butenes category have low sub-chronic toxicity. Inhalation exposure is the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies of up to 2 years in rats or mice. Nasal lesions were observed in 2 year rodent studies at the highest concentration but are considered to be a non-adverse adaptation to chronic exposure to a hydrocarbon. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7f57f27-529c-458e-ae7e-09d24764eeff/documents/6b665189-4f72-41a2-a8d5-6e3a12f6123f_19d2c55b-005e-4fad-9951-a10287473047.html,,,,,, 2-butene,107-01-7,"Members of the butenes category are flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. Members of the butenes category have low acute inhalation toxicity. The LC50 for but-2 -ene is greater than 10,000 ppm (22,948 mg/m3). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7f57f27-529c-458e-ae7e-09d24764eeff/documents/a952f1cf-a06d-4ef5-ac6e-1ab8b1756557_19d2c55b-005e-4fad-9951-a10287473047.html,,,,,, "(2Z)-1,1,1,4,4,4-hexafluorobut-2-ene",692-49-9,"Inhalation: OECD 413; rats. NOAEC = 5000 ppm (33548 mg/m3) in males based on test substance-related reductions in body weight and food consumption at 7500 ppm, and 7500 ppm (50322 mg/m3) in females based on no effects observed at the highest concentration tested. Reliability = 1. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8189380a-72f2-484a-8052-edb36c77b926/documents/2b8d4cd3-99a7-478d-9b87-43f091b2c612_d49b228c-6c72-4e14-84d8-1ecf4b49018b.html,,,,,, "(2Z)-1,1,1,4,4,4-hexafluorobut-2-ene",692-49-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8189380a-72f2-484a-8052-edb36c77b926/documents/2b8d4cd3-99a7-478d-9b87-43f091b2c612_d49b228c-6c72-4e14-84d8-1ecf4b49018b.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"33,548 mg/m3",,rat "(2Z)-1,1,1,4,4,4-hexafluorobut-2-ene",692-49-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8189380a-72f2-484a-8052-edb36c77b926/documents/2b8d4cd3-99a7-478d-9b87-43f091b2c612_d49b228c-6c72-4e14-84d8-1ecf4b49018b.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"33,548 mg/m3",no adverse effect observed,rat "(2Z)-1,1,1,4,4,4-hexafluorobut-2-ene",692-49-9,Inhalation: OECD 403; rat 4-hr LC50 >102900 ppm (>690413 mg/m3). Reliability =2 ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8189380a-72f2-484a-8052-edb36c77b926/documents/bd534cf6-792b-41df-b5aa-d60d447eaf5d_d49b228c-6c72-4e14-84d8-1ecf4b49018b.html,,,,,, "(2Z)-1,1,1,4,4,4-hexafluorobut-2-ene",692-49-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8189380a-72f2-484a-8052-edb36c77b926/documents/bd534cf6-792b-41df-b5aa-d60d447eaf5d_d49b228c-6c72-4e14-84d8-1ecf4b49018b.html,,inhalation,LC50,"690,413 mg/m3",no adverse effect observed, "2-Butenedioic acid (2E)-, di-C14-16 (even numbered)-alkyl esters",1187576-41-5,"In conclusion, no human hazard for systemic toxicity after repeated oral exposure was identified for the PFAE fumarate category members. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a27d1c1-3a58-4c5d-86eb-31aa4a5d6043/documents/IUC5-706620aa-7a06-4786-93d8-359af91055fa_2344c8d7-ae55-4be0-aea6-99590b82577c.html,,,,,, "2-Butenedioic acid (2E)-, di-C14-16 (even numbered)-alkyl esters",1187576-41-5,The available acute oral toxicity studies within this category resulted in an acute oral LD50 value > 2000 mg/kg bw. The available acute dermal toxicity studies within the category resulted in an acute dermal LD50 value > 2000 mg/kg bw. Inhalation: no study available ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a27d1c1-3a58-4c5d-86eb-31aa4a5d6043/documents/IUC5-0443668e-c2b5-4177-a217-b222f6908e90_2344c8d7-ae55-4be0-aea6-99590b82577c.html,,,,,, "2-Butenedioic acid (2Z)-, reaction products with ammonium di-µ3-hydroxyhexacosa-µ-oxododecaoxododecatungstate(6-) (6:1), ammonium octa-µ-oxodi-µ3-oxo-µ4-oxododecaoxoheptamolybdate(6-) (6:1), nickel(2+) nitrate (1:2) and nickel(2+) sulfate (1:1)",1351378-24-9,"Oral, rat: estimated LD50: 1000 mg/kg bw (Colas, 2012) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac284399-e5ff-488d-a2d9-55eb1e1dad8f/documents/IUC5-c8d31560-d8db-424b-abab-2b077d2355c4_9ff79488-863d-4d8b-a154-ba6de862554a.html,,,,,, "2-Butenedioic acid (2Z)-, reaction products with ammonium di-µ3-hydroxyhexacosa-µ-oxododecaoxododecatungstate(6-) (6:1), ammonium octa-µ-oxodi-µ3-oxo-µ4-oxododecaoxoheptamolybdate(6-) (6:1), nickel(2+) nitrate (1:2) and nickel(2+) sulfate (1:1)",1351378-24-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac284399-e5ff-488d-a2d9-55eb1e1dad8f/documents/IUC5-c8d31560-d8db-424b-abab-2b077d2355c4_9ff79488-863d-4d8b-a154-ba6de862554a.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, "2-Butenedioic acid (E)-, di-C12-18-alkyl esters",68921-51-7,"In conclusion, no human hazard for systemic toxicity after repeated oral exposure was identified for the PFAE fumarate category members. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/519339ea-e3b2-4483-910e-0e278d626e05/documents/IUC5-55795241-a82e-4ad2-bfe3-115cae178223_931e8718-a631-4155-9f8b-388952f42f02.html,,,,,, "2-Butenedioic acid (E)-, di-C12-18-alkyl esters",68921-51-7,The available acute oral toxicity study within this category (according to OECD TG 423) resulted in an acute oral LD50 value > 5000 mg/kg bw. The available acute dermal toxicity study within the category (according to OECD TG 402) resulted in an acute dermal LD50 value > 5000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/519339ea-e3b2-4483-910e-0e278d626e05/documents/IUC5-2ef17686-e2d5-413a-a591-ab413a7edaf1_931e8718-a631-4155-9f8b-388952f42f02.html,,,,,, "2-Butenedioic acid (E)-, di-C16-18-alkyl esters",68921-52-8,"In conclusion, no human hazard for systemic toxicity after repeated oral exposure was identified for the PFAE fumarate category members. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd4e1cfe-ddc3-468b-810c-c1fb13f22516/documents/IUC5-55795241-a82e-4ad2-bfe3-115cae178223_15f33c8f-ad3a-4665-8ed3-50c385795c70.html,,,,,, "2-Butenedioic acid (E)-, di-C16-18-alkyl esters",68921-52-8,The available acute oral toxicity study within this category (according to OECD TG 423) resulted in an acute oral LD50 value > 5000 mg/kg bw. The available acute dermal toxicity study within the category (according to OECD TG 402) resulted in an acute dermal LD50 value > 5000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd4e1cfe-ddc3-468b-810c-c1fb13f22516/documents/IUC5-2ef17686-e2d5-413a-a591-ab413a7edaf1_15f33c8f-ad3a-4665-8ed3-50c385795c70.html,,,,,, "2-Butenedioic acid (E)-, di-C18-22-alkyl esters",68921-53-9,"In conclusion, no human hazard for systemic toxicity after repeated oral exposure was identified for the PFAE fumarate category members. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44bef1c5-5380-4535-819e-48be86151923/documents/IUC5-55795241-a82e-4ad2-bfe3-115cae178223_d1fa853d-a463-4fdb-82ff-f9f0e178b8e8.html,,,,,, "2-Butenedioic acid (E)-, di-C18-22-alkyl esters",68921-53-9,The available acute oral toxicity study within this category (according to OECD TG 423) resulted in an acute oral LD50 value > 5000 mg/kg bw. The available acute dermal toxicity study within the category (according to OECD TG 402) resulted in an acute dermal LD50 value > 5000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44bef1c5-5380-4535-819e-48be86151923/documents/IUC5-2ef17686-e2d5-413a-a591-ab413a7edaf1_d1fa853d-a463-4fdb-82ff-f9f0e178b8e8.html,,,,,, "2-Butenedioic acid (E)-, di-C8-18-alkyl esters",68610-90-2,"In conclusion, no human hazard for systemic toxicity after repeated oral exposure was identified for the PFAE fumarate category members. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0cf4e67-b460-42e6-b58b-20e66b17139b/documents/301899dd-2a53-4bfc-b523-33aaccc4b7f1_921ca1b0-b746-431f-974f-8377b4ea0a6b.html,,,,,, "2-Butenedioic acid (E)-, di-C8-18-alkyl esters",68610-90-2,"LD50 (oral) > 2000 mg/kg bw, LD50 (dermal) > 5000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0cf4e67-b460-42e6-b58b-20e66b17139b/documents/f934bce1-5a05-478b-aaf6-a0d03aa07214_921ca1b0-b746-431f-974f-8377b4ea0a6b.html,,,,,, "2-Butenedioic acid (E)-, di-C8-18-alkyl esters",68610-90-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0cf4e67-b460-42e6-b58b-20e66b17139b/documents/f934bce1-5a05-478b-aaf6-a0d03aa07214_921ca1b0-b746-431f-974f-8377b4ea0a6b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Butenedioic acid (E)-, di-C8-18-alkyl esters",68610-90-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0cf4e67-b460-42e6-b58b-20e66b17139b/documents/f934bce1-5a05-478b-aaf6-a0d03aa07214_921ca1b0-b746-431f-974f-8377b4ea0a6b.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, C12-15 Alkyl Fumarate,142104-11-8,Study conducted to recognised testing guidelines with GLP certification. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4891f2f2-d7bd-4734-b4bc-13c428a16340/documents/bcd396e3-3ad1-43dd-899d-d27090ac14a9_f625326a-40e1-4b97-8a55-1cdab2cb7161.html,,,,,, C12-15 Alkyl Fumarate,142104-11-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4891f2f2-d7bd-4734-b4bc-13c428a16340/documents/bcd396e3-3ad1-43dd-899d-d27090ac14a9_f625326a-40e1-4b97-8a55-1cdab2cb7161.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, C12-15 Alkyl Fumarate,142104-11-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4891f2f2-d7bd-4734-b4bc-13c428a16340/documents/bcd396e3-3ad1-43dd-899d-d27090ac14a9_f625326a-40e1-4b97-8a55-1cdab2cb7161.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, di(2-ethylhexyl) (2Z)-2-methyl-2-butenedioate,1354569-12-2,"In accordance with REACH Article 18, testing is not required for this type of submission. There are two QSAR models conducted on repeated dose toxicity: i) DEREK Nexus model, rated as Klimisch 4, and ii) TOPKAT model (Klimisch 2) predicting a rat chronic LOAEL of 141 mg/kg. This was used as weight of evidence for classification and labelling and PBT assessment. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c8b6dbd-c1a8-48de-b308-5f12ab0395c6/documents/IUC5-b24e5743-6576-46f1-b935-42aa0934f2ac_ac0ac9b9-8621-4578-b27f-0a4f6381f215.html,,,,,, di(2-ethylhexyl) (2Z)-2-methyl-2-butenedioate,1354569-12-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c8b6dbd-c1a8-48de-b308-5f12ab0395c6/documents/IUC5-b24e5743-6576-46f1-b935-42aa0934f2ac_ac0ac9b9-8621-4578-b27f-0a4f6381f215.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,141 mg/kg bw/day,,rat di(2-ethylhexyl) (2Z)-2-methyl-2-butenedioate,1354569-12-2,"An oral limit test in rats (OECD 423, non-GLP, Klimisch 2). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c8b6dbd-c1a8-48de-b308-5f12ab0395c6/documents/IUC5-bde84878-e273-45da-8756-3786b59f6564_ac0ac9b9-8621-4578-b27f-0a4f6381f215.html,,,,,, di(2-ethylhexyl) (2Z)-2-methyl-2-butenedioate,1354569-12-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c8b6dbd-c1a8-48de-b308-5f12ab0395c6/documents/IUC5-bde84878-e273-45da-8756-3786b59f6564_ac0ac9b9-8621-4578-b27f-0a4f6381f215.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-methylpentan-3-yl (2E)-but-2-enoate,1370711-06-0,"The repeated dose toxicity of the test substance, TM 12-209, was assessed in rats according to OECD Test Guideline 407. The test item was administered by continuous dietary admixture to rats, for twenty-eight consecutive days, at dietary concentrations of 500, 3500 and 15000 ppm (equivalent to a mean achieved dosage of 26.4, 215.1 and 1010.7 mg/kg bw/day for males and 28.5, 254.3 and 1110.3 mg/kg bw/day for females respectively). The control group was treated with basal laboratory diet. Two recovery groups were treated with the high dose (15000 ppm) or basal laboratory diet for twenty-eight consecutive days and then maintained without treatment for a further fourteen days. Each group had five males and five females. Clinical signs, body weight change, food and water consumption were monitored during the study. Hematology, blood chemistry and urinalysis were evaluated at the end of treatment. All animals were subjected to gross necropsy examination and histopathological examination of selected tissues was performed. The microscopic changes in the prostate, seminal vesicles and coagulating glands and the associated changes in the weight of these organs in males treated with 15000 ppm were considered to represent an adverse effect of treatment. Additionally, granular casts and corticomedullary tubular basophilia in the kidneys of males treated with 15000 ppm were considered to indicate an effect of nephrotoxicity and therefore also represent an adverse effect of treatment. Hyaline droplet formation was observed in the kidneys of males from control, treatment and recovery groups but this effect is a species and sex specific condition in rats and therefore normally does not represent a risk to humans. For these reasons, the No Observed Adverse Effect Level (NOAEL) for systemic toxicity was 3500 ppm for males (equivalent to 215.1 mg/kg bw/day) and 15000 ppm for females (equivalent to 1110.3 mg/kg bw/day). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51f9b3f4-8bfb-41df-b410-63dd002a4313/documents/IUC5-25405aa8-4e4f-47c2-bc7c-84a6ef0e3710_517f7395-3adb-4b6e-8ddc-852b1d497bdf.html,,,,,, 2-methylpentan-3-yl (2E)-but-2-enoate,1370711-06-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51f9b3f4-8bfb-41df-b410-63dd002a4313/documents/IUC5-25405aa8-4e4f-47c2-bc7c-84a6ef0e3710_517f7395-3adb-4b6e-8ddc-852b1d497bdf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,215 mg/kg bw/day,,rat 2-methylpentan-3-yl (2E)-but-2-enoate,1370711-06-0,"The acute oral toxicity of the test substance, TM 12-209, was estimated to be greater than 2000 mg/kg body weight according to OECD Test Guideline 423 using the Acute Toxic Class Method. The test item does not meet the criteria for classification according to Regulation (EC) No 1272 / 2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures. The acute dermal toxicity of the test substance, TM 12-209, was greater than 2000mg/kg body weight according to OECD Test Guideline 402 using the fixed dose method. The test item does not meet the criteria for classification according to the Globally Harmonised System of Classification and Labelling of Chemicals. The acute inhalation toxicity of the test substance, TM 12-209, was assessed according to OECD Test Guideline 403 using a standard acute method and gave an acute inhalation median lethal concentration (4 hr LC50) of greater than 5.42 mg/L according to OECD Test Guideline 403 using a standard acute method. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51f9b3f4-8bfb-41df-b410-63dd002a4313/documents/IUC5-2c78547a-3b4c-4186-b789-2bdf955f84ea_517f7395-3adb-4b6e-8ddc-852b1d497bdf.html,,,,,, 2-methylpentan-3-yl (2E)-but-2-enoate,1370711-06-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51f9b3f4-8bfb-41df-b410-63dd002a4313/documents/IUC5-2c78547a-3b4c-4186-b789-2bdf955f84ea_517f7395-3adb-4b6e-8ddc-852b1d497bdf.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-methylpentan-3-yl (2E)-but-2-enoate,1370711-06-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51f9b3f4-8bfb-41df-b410-63dd002a4313/documents/IUC5-2c78547a-3b4c-4186-b789-2bdf955f84ea_517f7395-3adb-4b6e-8ddc-852b1d497bdf.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-methylpentan-3-yl (2E)-but-2-enoate,1370711-06-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51f9b3f4-8bfb-41df-b410-63dd002a4313/documents/IUC5-2c78547a-3b4c-4186-b789-2bdf955f84ea_517f7395-3adb-4b6e-8ddc-852b1d497bdf.html,,inhalation,LC50,5.42 mg/m3,no adverse effect observed, isopropyl (E)-3-aminobut-2-enoate,14205-46-0,"Oral (Rat-Wistar, GLP): LD50 > 2000 mg/kgInhalation (Rat-Wistar, GLP, OECD TG 403): LC50 > 6064 mg/m³ ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e540ca94-7db9-43d5-9d59-46c8fdce5667/documents/IUC5-fbe37bfe-5b42-4a7a-a560-bb43e0ed2e38_171f14db-231c-488d-9ceb-1c57eddde22a.html,,,,,, isobutyl (2Z)-3-aminobut-2-enoate,52937-90-3,Oral (Rat-Wistar): LD50 1400 mg/kg ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8386d23-9687-4f31-b241-7435fe53d409/documents/IUC5-17ca95fe-9af5-4fa6-83c3-feceb2ab8cd1_40af3dcb-3715-4e6e-87f5-8784a1f33abd.html,,,,,, 2-butoxyethyl benzoate,5451-76-3, There is a key GLP-study according to OECD guideline 408 and a supporting GLP-study according to OECD guideline 422 available for 2-butoxyethyl benzoate. ,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b9d6377-6996-4f3f-9d30-82e5da45f745/documents/7b57f1b3-d8ac-4703-80f4-f1c2f5921b08_578b7d9f-2486-40e0-addd-81edce02c639.html,,,,,, 2-butoxyethyl benzoate,5451-76-3,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b9d6377-6996-4f3f-9d30-82e5da45f745/documents/7b57f1b3-d8ac-4703-80f4-f1c2f5921b08_578b7d9f-2486-40e0-addd-81edce02c639.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,94.9 mg/kg bw/day,,rat 2-butoxyethyl benzoate,5451-76-3," GLP-studies according to OECD guidelines 402, 403 and 425 are available for 2-butoxyethyl benzoate. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b9d6377-6996-4f3f-9d30-82e5da45f745/documents/b99ef8f1-dcb5-456c-8938-654e9506ca05_578b7d9f-2486-40e0-addd-81edce02c639.html,,,,,, 2-butoxyethyl benzoate,5451-76-3,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b9d6377-6996-4f3f-9d30-82e5da45f745/documents/b99ef8f1-dcb5-456c-8938-654e9506ca05_578b7d9f-2486-40e0-addd-81edce02c639.html,,oral,LD50,939.8 mg/kg bw,adverse effect observed, 2-butoxyethyl methacrylate,13532-94-0," An assessment in accordance with REACH regulation ((EC) No 1907/2006) was performed to consider the prospect to apply Annex XI adaption rules based on exposure to 2-butoxyethylmethacrylate. According to section 8.6.1. of Annex VIII of the REACH regulation ((EC) No 1907/2006), testing for short-term repeated-dose toxicity does not need to be conducted if relevant human exposure can be excluded in accordance with Annex XI Section 3. It was concluded that the use of Annex XI to waive the short-term repeated dose toxicity study based on exposure to the substance was appropriate. Further testing is therefore considered not required. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9686bcf2-2f13-4dfd-b789-6a360c1b7357/documents/287e661c-a441-4536-90d7-2e5ea73e9930_ae1f97f8-add8-4382-9fd6-8513ab6b4a3b.html,,,,,, 2-butoxyethyl methacrylate,13532-94-0,"An LD50 of 2996 mg/kg bw was estimated for acute toxicity via the oral route following a 15-day in vivo study in rats administered 2-butoxyethyl methacrylate at a dose range of 1000 - 8000 mg/kg bw. Mortality at 10, 50, 70, and 90 % was reported for 1000, 3000, 5000, and 8000 mg/kg bw respectively. Considerable change to rat behaviour and outward appearance was recorded at all doses as well as internal macroscopic organ change from 3000 mg/kg bw 2-butoxyethyl methacrylate. It was not considered appropriate to attempt an inhalation toxicity study based on the vapour pressure of the substance. Similarly, acute dermal toxicity was not tested based on the substance not meeting the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects being observed in, in vivo studies with dermal exposure. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9686bcf2-2f13-4dfd-b789-6a360c1b7357/documents/10a1c95d-a42b-4e53-9f9a-4fdfd398ed29_ae1f97f8-add8-4382-9fd6-8513ab6b4a3b.html,,,,,, 2-butoxyethyl methacrylate,13532-94-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9686bcf2-2f13-4dfd-b789-6a360c1b7357/documents/10a1c95d-a42b-4e53-9f9a-4fdfd398ed29_ae1f97f8-add8-4382-9fd6-8513ab6b4a3b.html,,oral,LD50,"2,996 mg/kg bw",no adverse effect observed, "2-butyl-6-(butylamino)-1H-benz[de]isoquinoline-1,3(2H)-dione",19125-99-6," Repeated dose toxicity: oral The No Observed Adverse Effect Level (NOAEL) for 2-butyl-6-(butylamino)-1H-benzo[de]isoquinoline-1,3(2H)-dione in rats is estimated to be 994 mg/Kg bw/day after repeated exposure via oral route. Repeated dose toxicity: inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 2-butyl-6-(butylamino)-1H-benzo[de]isoquinoline-1,3(2H)-dione, which is reported as 0.00000000141 Pa. Also considering the particle size distribution of the substance the majority of the particles was found to be in the size of 106 micrometer which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical 12-butyl-6-(butylamino)-1H-benzo[de]isoquinoline-1,3(2H)-dione is highly unlikely. Therefore this study is considered for waiver. Repeated dose toxicity: dermal The acute toxicity value for 2-butyl-6-(butylamino)-1H-benzo[de]isoquinoline-1,3(2H)-dione (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 2-butyl-6-(butylamino)-1H-benzo[de]isoquinoline-1,3(2H)-dione shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 2-butyl-6-(butylamino)-1H-benzo[de]isoquinoline-1,3(2H)-dione shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76cbefda-5a16-4712-a5e6-36c6558c3829/documents/c01b51c6-68b0-4dfb-85d3-6534420a116e_bb4abd6c-e032-4222-9ac3-d3ba2cb82355.html,,,,,, "2-butyl-6-(butylamino)-1H-benz[de]isoquinoline-1,3(2H)-dione",19125-99-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76cbefda-5a16-4712-a5e6-36c6558c3829/documents/c01b51c6-68b0-4dfb-85d3-6534420a116e_bb4abd6c-e032-4222-9ac3-d3ba2cb82355.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,994 mg/kg bw/day,,rat "2-butyl-6-(butylamino)-1H-benz[de]isoquinoline-1,3(2H)-dione",19125-99-6," Acute toxicity: oral The acute oral LD50 value of the test substance 2-butyl-6-(butylamino)-1H-benzo[de]isoquinoline-1,3(2H)-dione to rat is estimated to be 6658.47 mg/kg bw by OECD QSAR toolbox. Acute toxicity: inhalation The study need not be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Acute toxicity: dermal The acute dermal LD50 value of the test substance 2-butyl-6-(butylamino)-1H-benzo[de]isoquinoline-1,3(2H)-dione to rat is estimated to be 8157.12 mg/kg bw by OECD QSAR toolbox. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76cbefda-5a16-4712-a5e6-36c6558c3829/documents/IUC5-12669f40-2435-45b2-8ffd-f140ddf40962_bb4abd6c-e032-4222-9ac3-d3ba2cb82355.html,,,,,, "2-butyl-6-(butylamino)-1H-benz[de]isoquinoline-1,3(2H)-dione",19125-99-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76cbefda-5a16-4712-a5e6-36c6558c3829/documents/IUC5-12669f40-2435-45b2-8ffd-f140ddf40962_bb4abd6c-e032-4222-9ac3-d3ba2cb82355.html,,oral,LD50,"6,658.47 mg/kg bw",no adverse effect observed, "2-butyl-6-(butylamino)-1H-benz[de]isoquinoline-1,3(2H)-dione",19125-99-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76cbefda-5a16-4712-a5e6-36c6558c3829/documents/IUC5-12669f40-2435-45b2-8ffd-f140ddf40962_bb4abd6c-e032-4222-9ac3-d3ba2cb82355.html,,dermal,LD50,"8,157.12 mg/kg bw",no adverse effect observed, "2-Butyne-1,4-diol, polymer with 2-(chloromethyl)oxirane, brominated, dehydrochlorinated, methoxylated",68441-62-3," Both 4-week and 13-week inhalation toxicity studies have been conducted with Polyol IXOL B350 in which male and female rats were exposed for 6 hours/day, 5 days/week. Exposure to Polyol IXOL B350 at concentrations of 1 g/m3 or above for 28-days induced changes indicative of systemic toxicity (i.e. changes in haematology, clinical chemistry and organ weights), without any histopathological correlate. No systemic toxicity was observed at 0.3 g/m3. Therefore, 0.3 g/m3 was considered to be the NOAEC for systemic toxicity. Since evidence of local toxicity in the upper respiratory tract was still found at this concentration, a NOAEC for local effects could not be established. Exposure to Polyol IXOL® B350 at concentrations up to 300 mg/m3 (the highest concentration tested) for 90 days, did not result in any treatment-related changes in the parameters tested. Therefore, the high concentration level of 300 mg/m3 was considered to be the No-Observed-Adverse-Effect-Level (NOAEL) for systemic and local toxicity. Oral exposure to Polyol IXOL B350 (OECD 443, GLP) at dosages of 0, 75, 150 and 450 mg/kg bw/day resulted in treatment-related adverse findings consisting of intratubular hemorrhage in the kidneys of F0 males administered 450 mg/kg/day and thyroid adenomas in F0 males adminstered >75 mg/kg/day, one female adminstered 450 mg/kg/day, and one F1 male administered 75 mg/kg/day. It should be noted that the relevance of such thyroid effects in rat studies - in quantitative terms - to humans is limited. Therefore the kidney effect is considered the most critical effect of Polyol IXOL B350 after repeated oral exposure. Based on the available study, the overall NOAEL for systemic effects is 150 mg/kg bw/day. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ee1fd2a-dd17-4825-a5b6-e963b7e6d49a/documents/IUC5-ae6c1304-9a28-4cf4-8ae9-10de06f0768e_c1f00e41-bb13-4ab8-b179-aee589f8fa65.html,,,,,, "2-Butyne-1,4-diol, polymer with 2-(chloromethyl)oxirane, brominated, dehydrochlorinated, methoxylated",68441-62-3,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ee1fd2a-dd17-4825-a5b6-e963b7e6d49a/documents/IUC5-ae6c1304-9a28-4cf4-8ae9-10de06f0768e_c1f00e41-bb13-4ab8-b179-aee589f8fa65.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "2-Butyne-1,4-diol, polymer with 2-(chloromethyl)oxirane, brominated, dehydrochlorinated, methoxylated",68441-62-3,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ee1fd2a-dd17-4825-a5b6-e963b7e6d49a/documents/IUC5-ae6c1304-9a28-4cf4-8ae9-10de06f0768e_c1f00e41-bb13-4ab8-b179-aee589f8fa65.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,300 mg/m3,,rat "2-Butyne-1,4-diol, polymer with 2-(chloromethyl)oxirane, brominated, dehydrochlorinated, methoxylated",68441-62-3,"The substance showed moderate acute oral toxicity in male rats (LD50 = 1337 mg/kg bw). Regarding inhalation exposure, the 4-hour LC50 is above 5.47 g/m3 for male and female rats. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ee1fd2a-dd17-4825-a5b6-e963b7e6d49a/documents/IUC5-b27cba88-b596-42e7-8fc0-21c51213949a_c1f00e41-bb13-4ab8-b179-aee589f8fa65.html,,,,,, "2-chloro-2',6'-dimethylacetanilide",1131-01-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79fc8611-e712-40a9-b01c-420bb34ceed7/documents/a6294cbf-2ea6-4b5f-b979-0f21b6d5314e_27c93790-7efa-4d99-a234-7cc7c7aa998b.html,,oral,LD50,810 mg/kg bw,, 2-chloro-2-methylbutane,594-36-5," After a thorough research for compound related information in publicly available literature and database sources, no relevant data for this endpoint could be obtained. For this endpoint, there are data for other substances belonging to the class of alkyl chlorides available. The LD50 for 1,4-dichlorobutan, 1-chlorododecane and 1-chlorotetradecane after oral administration is above 2000 mg/kg. Thus, alkyl chlorides seem to have a low acute toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25f7b993-6571-48e2-ad33-264dc2672658/documents/c51b7174-0952-449d-be98-d2aa75f79b7c_7b3202a5-f322-4719-9c49-81d28798d4db.html,,,,,, "2-chloro-3',4'-dihydroxyacetophenone",99-40-1, The acute oral toxicity testing of Chloro acetyl cathecol in the rat yieded the following median lethal dose (LD50): Male and female animals: 226.6 mg/kg body weight ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/497bead7-7d71-44d2-90ed-f474f7658ddb/documents/599a38dc-2608-4650-ad30-8c707a219fcb_c7db5826-f1ed-4a4c-ba07-f305b9df6d2b.html,,,,,, "2-chloro-3',4'-dihydroxyacetophenone",99-40-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/497bead7-7d71-44d2-90ed-f474f7658ddb/documents/599a38dc-2608-4650-ad30-8c707a219fcb_c7db5826-f1ed-4a4c-ba07-f305b9df6d2b.html,,oral,LD50,226.6 mg/kg bw,adverse effect observed, "2-chloro-4,6-dimethoxy-1,3,5-triazine",3140-73-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): sufficient Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): sufficient ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52e9993c-1827-4dd0-bdb0-74b21eb7dbbc/documents/IUC5-8515963e-2958-4cfe-ae50-d64bb92e0bf3_463c3bfe-a1d1-4278-8d7b-e7f2b529cf73.html,,,,,, "2-chloro-4,6-dimethoxy-1,3,5-triazine",3140-73-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52e9993c-1827-4dd0-bdb0-74b21eb7dbbc/documents/IUC5-8515963e-2958-4cfe-ae50-d64bb92e0bf3_463c3bfe-a1d1-4278-8d7b-e7f2b529cf73.html,,oral,LD50,870 mg/kg bw,adverse effect observed, 2-chloro-4-nitrophenol,619-08-9," Acute oral toxicity:  Acute oral toxicity dose (LD50) was predicted based on OECD QSAR toolbox 1351 mg/kg bw, experimental study done by Deichmannet al(Toxicology of Drugs and Chemicals, P. 169, 1969), Richard J. Lewis, Sr.(Sax's Dangerous Properties of Industrial Materials. 12th Edition, 2012) and National Technical Reports Library (1992), 900 mg/kg bw and different studies available on structurally similar read across substance 3,5-Dichloronitrobenzene (618-62-2) 390 mg/kg bw and 1,2-dichloro-4-nitrobenzene (99-54-7)953 mg/kg bw. All these studies concluded that the LD50 value is between 300 - 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-chloro-4-nitrophenol can be classified as category IV of acute oral toxicity. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) was predicted based on OECD QSAR toolbox 1731 mg/kg bw, experimental study done by National Technical Reports Library (1992)Range of 1500 – 2000 mg/kg bw,and differentstudies available on structurally similar read across substance 4-nitrophenol (100-02-7) 1024 mg/kg bw and 1-Chloro-3-nitrobenzene (121-73-3) 890 mg/kg bw. All these studies concluded that the LD50 value isbetween 300 - 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-ethoxynaphthalene-1-carbonyl chloride can be classified as category IV of acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a1a295c-d2f2-47e0-af30-1816e78f578e/documents/56f4e1b0-7de3-4c47-99f9-c81ea4a85d4c_46d13e4e-31ea-47fe-b5fc-fd58a0602936.html,,,,,, 2-chloro-4-nitrophenol,619-08-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a1a295c-d2f2-47e0-af30-1816e78f578e/documents/56f4e1b0-7de3-4c47-99f9-c81ea4a85d4c_46d13e4e-31ea-47fe-b5fc-fd58a0602936.html,,oral,LD50,"1,351 mg/kg bw",adverse effect observed, 2-chloro-4-nitrophenol,619-08-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a1a295c-d2f2-47e0-af30-1816e78f578e/documents/56f4e1b0-7de3-4c47-99f9-c81ea4a85d4c_46d13e4e-31ea-47fe-b5fc-fd58a0602936.html,,dermal,LD50,"1,731 mg/kg bw",adverse effect observed, 2-chloro-5-methyl-4-nitropyridin-1-ium-1-olate,60323-96-8,"The substance registered according to Art. 17/Art. 18 REACh Regulation, has already been classified as Explosives according to Regulation (EC) No 1272/2008 and UN Transport Guideline (Test serie 3(a) (i), 3(b) (i) and 2(b)). For safety reasons further testing of any other physical hazard classes should not be considered, since the explosion is the expected predominant effect. According to Annex XI Section 2 of REACH Regulation, the testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a consequence of the properties of the substance. In this particular case, mixing the test substance with water can cause explosion. Heating the substance can also leads to an explosion. Due to this fact it is technically not feasible to conduct the studies as a consequence of the properties of the substance.     ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb015361-1241-468f-b37b-b9a28ce7e7cf/documents/451efe73-60eb-4b33-8451-2b4a77017338_a4a6e285-8559-42fa-b147-b18dd423fe8a.html,,,,,, 2-chloro-5-methylpyridin-1-ium-1-olate,20173-49-3,"Justification for Data Waiving The substance registered according to Art. 17/Art. 18 REACh Regulation, has already been classified as Explosives according to Regulation (EC) No 1272/2008 and UN Transport Guideline (Test serie 3(a) (i), 3(b) (i) and 2(b)). For safety reasons further testing of any other physical hazard classes should not be considered, since the explosion is the expected predominant effect. According to Annex XI Section 2 of REACH Regulation, the testing for a specific endpoint may be omitted, if it is technically not possible to conduct the study as a consequence of the properties of the substance. In this particular case, mixing the test substance with water can cause explosion. Heating the substance can also leads to an explosion. Due to this fact it is technically not feasible to conduct the studies as a consequence of the properties of the substance.     ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0169912e-6601-464a-9cf1-30f182547cb5/documents/5461df45-4f03-427e-a53a-ed53f0fd95fb_e69a2e55-d006-46f5-b8c1-0f9cc07a7b69.html,,,,,, "2-chloro-6,7-dimethoxyquinazolin-4-amine",23680-84-4," Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound 2-Chloro-6,7-dimethoxy-4-quinazolinamine. The study assumed the use of male and female Wistar rats in a study 5 days. No significant alterations were noted at the dose level of 566.666687012 mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for 2-Chloro-6,7-dimethoxy-4-quinazolinamine is considered to be 566.666687012 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0e4bd93-fb5e-46a3-b88c-480f7947b3ca/documents/IUC5-43f5efb3-8c0a-4f34-b36a-26fc70b54d51_85d97250-0237-47a5-8760-5c90317f60a1.html,,,,,, "2-chloro-6,7-dimethoxyquinazolin-4-amine",23680-84-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0e4bd93-fb5e-46a3-b88c-480f7947b3ca/documents/IUC5-43f5efb3-8c0a-4f34-b36a-26fc70b54d51_85d97250-0237-47a5-8760-5c90317f60a1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,566.667 mg/kg bw/day,,rat "2-chloro-6,7-dimethoxyquinazolin-4-amine",23680-84-4," Acute oral toxicity:  LD50 was estimated to be 958 mg/kg bw when male and female Wistar rats were treated with 2-Chloro-6, 7-dimethoxyquinazolin-4-amine by oral gavage route. Acute Dermal toxicity:  LD50 was estimated to be 3652 mg/kg bw when New Zealand White male rabbits were treated with 2-Chloro-6, 7-dimethoxyquinazolin-4-amine by dermal application occlusively for 24 h. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0e4bd93-fb5e-46a3-b88c-480f7947b3ca/documents/IUC5-55137e4f-7830-417e-962b-2b76449b2a73_85d97250-0237-47a5-8760-5c90317f60a1.html,,,,,, "2-chloro-6,7-dimethoxyquinazolin-4-amine",23680-84-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0e4bd93-fb5e-46a3-b88c-480f7947b3ca/documents/IUC5-55137e4f-7830-417e-962b-2b76449b2a73_85d97250-0237-47a5-8760-5c90317f60a1.html,,oral,LD50,958 mg/kg bw,adverse effect observed, "2-chloro-6,7-dimethoxyquinazolin-4-amine",23680-84-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0e4bd93-fb5e-46a3-b88c-480f7947b3ca/documents/IUC5-55137e4f-7830-417e-962b-2b76449b2a73_85d97250-0237-47a5-8760-5c90317f60a1.html,,dermal,LD50,"3,652 mg/kg bw",no adverse effect observed, 2'-chloroacetoacetanilide,93-70-9,"Key study similar to OECD Guideline 401, Bio Toxicity lab 1976: LD50 male rats 11'600 mg/kg bw Several supporting studies similar to OECD 401:1. Hoechst 209/78, Vehicle Propandiol 1,2, LD50 male rats 3'780 mg/kg bw2. Hoechst 897/77, Vehicle Polyglycol 400, LD50 female rats 4'580 mg/kg bw3. Hoechst 843 & 845/77, Vehicle Polyglycol 400, LD50 male rats 4'800 mg/kg bw and female rats 5'600 mg/kg bw4. Hoechst 842/77, Vehicle Starch slime 2%, LD50 female rats 4'860 mg/kg bw5. Hoechst 844 & 846/77, Vehicle Starch slime 2%, LD50 female and male rats 4'300 mg/kg bwA further supporting study was performed by Consultox Laboratories Ltd. for Lonza Ltd. in year 1973 with three different species. The following animals were used in these investigation: Mice: Tylers original strain, weighing approx. 20gRats: Female Wistar rats weighing approx. 200gRabbits: New Zealand White weighing approx. 2kgVehicle: was aqueous solution of Tween 80 or distilled waterAdministration: By gavage using metal cannulae for mice and rats and a rubber stomach catheter for rabbits.LD50 in mice = 1'900 (1'460-2'470) mg/kg bwLD50 in rats between 2'500 and 5'000 mg/kg bwLD50 in rabbits between 2'500 and 5'000 mg/kg bwIn a further acute toxicity study the Methemoglobin formation was determined in male cats. The study was performed in year 1965.At doses of 100 mg/kg and 500 mg/kg the test item has generated methemoglobin in the male cats.At doses of 500 mg/kg both cats died. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4204ef29-8fe9-42fe-81a0-24fb2d5a3fa8/documents/IUC5-f9cb692f-9a69-44e4-b294-3cc6eb49124f_b64a7920-91c9-4d46-9188-26ab3111581e.html,,,,,, 2'-chloroacetoacetanilide,93-70-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4204ef29-8fe9-42fe-81a0-24fb2d5a3fa8/documents/IUC5-f9cb692f-9a69-44e4-b294-3cc6eb49124f_b64a7920-91c9-4d46-9188-26ab3111581e.html,,oral,LD50,"3,780 mg/kg bw",, 2-chlorobenzonitrile,873-32-5,"An oral LD50 of 396 mg/kg in rat was determined the Hoechst AG (1973). This value was supported by RTECS (1980) and Zeller (1972).For the application of 2-chlorobenzonitrile in propylene glycole, a dermal LD50 between 340 and 600 mg/kg in rabbits was concluded by TNO (1976). However the result wasn't used, due to possible enhencement of the glycole.TNO (1974) reported no acute toxicity by inhalation (4h) at the maximum achievable concentration. This result was confirmed by Zeller (1972). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4dd485f-bb99-44e4-956b-9824ceddb59d/documents/abcdfc2f-6d0f-4494-bd7e-1cda93a5f0b4_122b5fe7-71cd-4cfa-af0e-8d99cd2a6e1c.html,,,,,, 2-chlorobenzonitrile,873-32-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4dd485f-bb99-44e4-956b-9824ceddb59d/documents/abcdfc2f-6d0f-4494-bd7e-1cda93a5f0b4_122b5fe7-71cd-4cfa-af0e-8d99cd2a6e1c.html,,oral,LD50,396 mg/kg bw,adverse effect observed, 2-chloroethanol,107-07-3,"The acute oral LD50 value of 2-chloroethanol derived from the key study in rats (BASF AG, 1978) is 77 mg/kg bw. The acute inhalation LC50 value (4 h) in rats is between 16 ppm (53 mg/m³) and 62 ppm (207 mg/m³).The acute dermal LD50 value of 2-chloroethanol derived from the key study in rabbits (Lawrence et al., 1971) is 68 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf3805de-2375-4bd0-9ffb-24503aa52d26/documents/IUC5-d42d4989-e7d9-4542-b480-ca64877f8ff9_0042e613-058b-4b48-b718-e245ea6fc7c1.html,,,,,, 2-chloroethanol,107-07-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf3805de-2375-4bd0-9ffb-24503aa52d26/documents/IUC5-d42d4989-e7d9-4542-b480-ca64877f8ff9_0042e613-058b-4b48-b718-e245ea6fc7c1.html,,oral,LD50,77 mg/kg bw,, 2-chloroethanol,107-07-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf3805de-2375-4bd0-9ffb-24503aa52d26/documents/IUC5-d42d4989-e7d9-4542-b480-ca64877f8ff9_0042e613-058b-4b48-b718-e245ea6fc7c1.html,,dermal,LD50,68 mg/kg bw,, 2-chloroethyldiethylammonium chloride,869-24-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): One high quality study is available and acceptable for the risk assessment. The most sensitive LD50 of both sexes, i.e., the LD50 of the females was used for the risk assessment. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83966a16-b476-4ab5-afee-8256a29db9ea/documents/IUC5-0c674f84-9c03-4019-82d2-3143664c3749_e60ea40b-7e42-4b78-a89c-f4eb50fa4622.html,,,,,, 2-chloroethyldiethylammonium chloride,869-24-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83966a16-b476-4ab5-afee-8256a29db9ea/documents/IUC5-0c674f84-9c03-4019-82d2-3143664c3749_e60ea40b-7e42-4b78-a89c-f4eb50fa4622.html,,oral,LD50,24 mg/kg bw,adverse effect observed, 2-chloroethyldimethylamine,107-99-3," For 2-Chloro-N,N-dimethylethan-1-amine, ACD/Percepta provided an LD50 prediction in mouse equal to 280 mg/kg and an LD50 prediction in rat equal to 87 mg/kg. The prediction was assessed as moderate reliable being the reliability index equal to 0.72 and 0.60 respectively.. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49aca746-ca43-41b1-bd98-53576f9f4e31/documents/becce330-efbc-4c6b-aa99-ab5b3f618665_bc70d4b0-8383-4744-b552-f7cc6e6bb4a4.html,,,,,, 2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide,64628-44-0,"The key studies for repeated dose toxicity endpoints are as follows:90-day oral (dietary) rat study (no guideline, pre-GLP, RL2), NOAEL = 3.6 mg/kg bw/day (M- 087617-01-1, Krotlinger, 1981)12-month oral (dietary) dog study (EPA 83-1, pre-GLP, RL2), NOAEL = 1.42 mg/kg bw/day (M- 087430-02-1 and M-087261-02-1, Hoffmann, 1984/89)21-day dermal rabbit study (OECD 410, GLP, RL1), NOAEL = 100 mg/kg bw/day (M- 086772-01-1, Krotlinger, 1990)The following supporting studies are available:28-day oral (gavage) rat study (no guideline, pre-GLP, RL2), NOAEL (male) = 300 mg/kg bw/day, NOAEL (female) = 100 mg/kg bw/day (M- 087319-01-1, Flucke, 1978)90-day oral (dietary) rat study (no guideline, pre-GLP, RL2), NOAEL = 3.6 mg/kg bw/day (M- 087254-01-1, Vogel, 1983, M-086368-01-1, Krotlinger, 1984)90-day oral (dietary) dog study (no guideline, pre-GLP, RL2), NOAEL = 2.68 mg/kg bw/day (M- 087344-01-1, Hoffmann, 1980)21-day dermal rabbit study (no guideline, pre-GLP, RL2), NOAEL = 50 mg/kg bw/day (M- 087328-01-1, Flucke, 1978)28-day inhalation rat study (no guideline, pre-GLP, RL3), NOAEC = 94.3 mg/m³ (M- 087340-01-1, Thyssen, 1979) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): A GLP and guideline study (OECD 410) in rabbits is available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): A GLP and guideline study (OECD 410) in rabbits is available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A comprehensive and high-quality database of repeated oral toxicity studies of up to chronic duration are available for the rat, mouse and dog. The available information comprises adequate, reliable (Klimisch score 2) and consistent studies, and is thus sufficient to fulfil the standard information requirements set out in Annex VII and VIII of Regulation (EC) No 1907/2006. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ada1d545-c503-4770-bb48-668361111a3f/documents/9ef2dee5-304a-4553-8309-ce3744110667_1942d664-5563-413c-a318-6168b3ee8ccd.html,,,,,, 2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide,64628-44-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ada1d545-c503-4770-bb48-668361111a3f/documents/9ef2dee5-304a-4553-8309-ce3744110667_1942d664-5563-413c-a318-6168b3ee8ccd.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,,rabbit 2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide,64628-44-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ada1d545-c503-4770-bb48-668361111a3f/documents/9ef2dee5-304a-4553-8309-ce3744110667_1942d664-5563-413c-a318-6168b3ee8ccd.html,Chronic toxicity – systemic effects,oral,NOAEL,1.42 mg/kg bw/day,,dog 2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide,64628-44-0,"The key studies for acute oral toxicity endpoints are as follows: Oral (OECD 401, GLP, RL1), rat LD50 > 5000 mg/kg bw (M-064546-01-1, Johnson, 2002)Dermal (OECD 402, GLP, RL1), rat LD50 > 5000 mg/kg bw (limit test) (M-064572-01-1, Johnson, 2002)Inhalation: (OECD 403, GLP, RL1), rat LC50 > 5 mg/L (M-078710-01-1, Pauluhn, 2002) The following supporting studies are available: Oral (non-guideline, non-GLP, RL2), rat LD50 > 5000 mg/kg bw (M-087278-01-1, Flucke, 1977)Oral (non-guideline, non-GLP, RL2), mouse LD50 > 5000 mg/kg bw (M-087278-01-1, Flucke, 1977)Oral (non-guideline, non-GLP, RL2), dog LD50 > 1000 mg/kg bw (M-087278-01-1, Flucke, 1977)Dermal (non-guideline, non-GLP, RL2), rat LD50 > 5000 mg/kg bw (M-087278-01-1, Flucke, 1978)Inhalation: (non-guideline, non-GLP, RL2), rat LC50 > 1.5 mg/L (M-086890-01-1, Sangha, 1981) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): An acute oral toxicity study in rat is available (GLP, OECD 401, Klimisch 1). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): An acute inhalation study in rat is available (GLP, OECD 403, Klimisch 1). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): An acute dermal study in rat is available (GLP, OECD 402, Klimisch 1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ada1d545-c503-4770-bb48-668361111a3f/documents/e1b6c6f2-19ed-45b7-ba6a-b1bc650556ff_1942d664-5563-413c-a318-6168b3ee8ccd.html,,,,,, 2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide,64628-44-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ada1d545-c503-4770-bb48-668361111a3f/documents/e1b6c6f2-19ed-45b7-ba6a-b1bc650556ff_1942d664-5563-413c-a318-6168b3ee8ccd.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, 2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide,64628-44-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ada1d545-c503-4770-bb48-668361111a3f/documents/e1b6c6f2-19ed-45b7-ba6a-b1bc650556ff_1942d664-5563-413c-a318-6168b3ee8ccd.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, 2-chloro-N-[[[4-(trifluoromethoxy)phenyl]amino]carbonyl]benzamide,64628-44-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ada1d545-c503-4770-bb48-668361111a3f/documents/e1b6c6f2-19ed-45b7-ba6a-b1bc650556ff_1942d664-5563-413c-a318-6168b3ee8ccd.html,,inhalation,LC50,> 5 mg/L,no adverse effect observed, 2-chlorophenol,95-57-8," NOAEL (28 days, rats): 1000 mg/kg bw/day (based on overall assessment and quality of the data base) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c962ebbb-b7c0-4573-8e22-08357512fbeb/documents/a0e15c33-27e0-4dae-871d-878d2d9a6ee3_d1d63bcc-9229-42e7-9bd9-2ef6464d2d58.html,,,,,, 2-chlorophenol,95-57-8," acute toxicity, oral (OECD 401, RL1), male rats: LD50 > 1000 > 2000 mg/kg bw acute toxicity, inhalation (OECD 403, RL2), rats: LC50 > 4.77 mg/L air acute toxicity, dermal (no guideline followed, RL2): LD50 > 1000 > 1580 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c962ebbb-b7c0-4573-8e22-08357512fbeb/documents/f14eb57d-ec00-4cfa-9633-1043bd446015_d1d63bcc-9229-42e7-9bd9-2ef6464d2d58.html,,,,,, 2-chlorophenol,95-57-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c962ebbb-b7c0-4573-8e22-08357512fbeb/documents/f14eb57d-ec00-4cfa-9633-1043bd446015_d1d63bcc-9229-42e7-9bd9-2ef6464d2d58.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, 2-chlorophenol,95-57-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c962ebbb-b7c0-4573-8e22-08357512fbeb/documents/f14eb57d-ec00-4cfa-9633-1043bd446015_d1d63bcc-9229-42e7-9bd9-2ef6464d2d58.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, 2-chlorophenol,95-57-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c962ebbb-b7c0-4573-8e22-08357512fbeb/documents/f14eb57d-ec00-4cfa-9633-1043bd446015_d1d63bcc-9229-42e7-9bd9-2ef6464d2d58.html,,inhalation,LC50,"4,770 mg/m3",adverse effect observed, 2-chloropropionic acid,598-78-7,"Four repeat dose studies have been reported. One was performed unequivocally with the racemic mixture and the 2nd (004) was also assumed to use racemic material, the other two used the L(+)isomer specifically. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9668281-897e-4eb0-9095-648810434982/documents/IUC5-a066af50-e5b3-47b4-912e-d314179f3cc7_b28a47c7-9dc7-44ac-8747-5d687f9f8a8b.html,,,,,, 2-chloropropionic acid,598-78-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9668281-897e-4eb0-9095-648810434982/documents/IUC5-a066af50-e5b3-47b4-912e-d314179f3cc7_b28a47c7-9dc7-44ac-8747-5d687f9f8a8b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat 2-chloropropionic acid,598-78-7,"According to the CLP Regulation EC 1272/2008 Annex VI the substance is classified as Harmful, Xn R22 for acute oral toxicity or Acute Toxicity 4 (H302). A number of literature studies are reported from publicly available sources which support this classification. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9668281-897e-4eb0-9095-648810434982/documents/IUC5-65b8f7c4-f79c-4eed-8c86-3d38758b3b4a_b28a47c7-9dc7-44ac-8747-5d687f9f8a8b.html,,,,,, 2-chloropropionic acid,598-78-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9668281-897e-4eb0-9095-648810434982/documents/IUC5-65b8f7c4-f79c-4eed-8c86-3d38758b3b4a_b28a47c7-9dc7-44ac-8747-5d687f9f8a8b.html,,oral,LD50,400 mg/kg bw,adverse effect observed, 2-chlorotoluene,95-49-8,"In dogs (four animals/sex/group) 2-chlorotoluene was orally applied in doses of 0, 20, 80 and 320 mg/kg bw and day by capsule for 3 months. The resulting NOEL was 20 mg/kg bw and day (Gibson et al. 1974b, Hill 1981). In all dose groups there were no treatment related effects on behaviour, survival, hematology, clinical chemistry, histopathology, eyes and bone marrow. Occasional episodes of vomiting in 1/4 females and red blood in the feces of this animal given 80 mg/kg bw is regarded to be the physiological response to the treatment with the slightly irritating compound. Therefore, a NOEL was set at 20 mg/kg bw/d. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d485e1c-3bad-49b6-a65f-360f5bb9259c/documents/IUC5-a0b8de7f-c1aa-4a25-8b34-804dc27b2054_d00df8c6-5797-48de-b1d6-d1aa23f9ddea.html,,,,,, 2-chlorotoluene,95-49-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d485e1c-3bad-49b6-a65f-360f5bb9259c/documents/IUC5-a0b8de7f-c1aa-4a25-8b34-804dc27b2054_d00df8c6-5797-48de-b1d6-d1aa23f9ddea.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,dog 2-chlorotoluene,95-49-8,"The LD50 for acute oral toxicity is > 3227 mg/kg bw. For acute inhalation toxicity a LD50 = 37.5 mg/l (rat, male) was found. In an additional inhalation study male rats and mice were exposed for 1 hour to 20.583 mg/l of the test substance. None of the animals died. For the endpoint dermal acute toxicity a Waiver is included since reliable oral and inhalation toxicity studies are available. However,  a supporting study (RL2, Bayer, 1976) shows that the LD50 is >1.08 g/kg bw (rats, limit dose test). This is supported by two non-reliable studies showing LD50 values above 2000 mg/kg bw/d, the limit for classification. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d485e1c-3bad-49b6-a65f-360f5bb9259c/documents/IUC5-2dbacd2e-1cb2-4745-a603-0e56886d2a69_d00df8c6-5797-48de-b1d6-d1aa23f9ddea.html,,,,,, 2-chlorotoluene,95-49-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d485e1c-3bad-49b6-a65f-360f5bb9259c/documents/IUC5-2dbacd2e-1cb2-4745-a603-0e56886d2a69_d00df8c6-5797-48de-b1d6-d1aa23f9ddea.html,,oral,LD50,"3,227 mg/kg bw",adverse effect observed, 2-chlorotoluene,95-49-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d485e1c-3bad-49b6-a65f-360f5bb9259c/documents/IUC5-2dbacd2e-1cb2-4745-a603-0e56886d2a69_d00df8c6-5797-48de-b1d6-d1aa23f9ddea.html,,dermal,discriminating dose,1.08 mg/kg bw,no adverse effect observed, 2-chlorotoluene,95-49-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d485e1c-3bad-49b6-a65f-360f5bb9259c/documents/IUC5-2dbacd2e-1cb2-4745-a603-0e56886d2a69_d00df8c6-5797-48de-b1d6-d1aa23f9ddea.html,,inhalation,LC50,37.5 mg/m3,adverse effect observed, "2-cyano-2-[2,3-dihydro-3-(tetrahydro-2,4,6-trioxo-5(2H)-pyrimidinylidene)-1H-isoindol-1-ylidene]-N-methylacetamide",76199-85-4,"Repeated dose toxicity: oral Key: oral, rat, 28 day study: NOEL (male/female) = 1000 mg/kg bw/day (GLP, OECD 407 with restrictions, 2000)   Repeated dose toxicity: inhalative Read-across to CAS 36888-99-0: Key: inhalative, rat, 5 day study with 3 weeks recovery: NOAEC (local) = 5 mg/m3 air, NOAEC (systemic) = 60 mg/m3 air (GLP, similar to OECD 412, 2022) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d33b90a-86fc-4809-b67c-7fbcb3215a47/documents/IUC5-c46767be-6bc2-4f2a-bd58-d8c72b8ea718_b78f3373-ff9e-4f55-9a99-3017f80f15d3.html,,,,,, "2-cyano-2-[2,3-dihydro-3-(tetrahydro-2,4,6-trioxo-5(2H)-pyrimidinylidene)-1H-isoindol-1-ylidene]-N-methylacetamide",76199-85-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d33b90a-86fc-4809-b67c-7fbcb3215a47/documents/IUC5-c46767be-6bc2-4f2a-bd58-d8c72b8ea718_b78f3373-ff9e-4f55-9a99-3017f80f15d3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-cyano-2-[2,3-dihydro-3-(tetrahydro-2,4,6-trioxo-5(2H)-pyrimidinylidene)-1H-isoindol-1-ylidene]-N-methylacetamide",76199-85-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d33b90a-86fc-4809-b67c-7fbcb3215a47/documents/IUC5-c46767be-6bc2-4f2a-bd58-d8c72b8ea718_b78f3373-ff9e-4f55-9a99-3017f80f15d3.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,60 mg/m3,,rat "2-cyano-2-[2,3-dihydro-3-(tetrahydro-2,4,6-trioxo-5(2H)-pyrimidinylidene)-1H-isoindol-1-ylidene]-N-methylacetamide",76199-85-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d33b90a-86fc-4809-b67c-7fbcb3215a47/documents/IUC5-c46767be-6bc2-4f2a-bd58-d8c72b8ea718_b78f3373-ff9e-4f55-9a99-3017f80f15d3.html,Repeated dose toxicity – local effects,inhalation,NOAEC,5 mg/m3,adverse effect observed,rat "2-cyano-2-[2,3-dihydro-3-(tetrahydro-2,4,6-trioxo-5(2H)-pyrimidinylidene)-1H-isoindol-1-ylidene]-N-methylacetamide",76199-85-4,"Key: oral, rat: LD50 > 5000 mg/kg bw; signs of toxicity: no clinical signs observed (non-GLP, OECD 401, 1982) Key: inhalative, rat: LC50 >5.42 mg dust/L air; signs of toxicity: no mortality and no toxicity observed (non-GLP, similar to OECD 403, 1982) Sup: intraperitoneal, rat: LD50 > 2000 mg/kg bw; signs of toxicity: no mortality; dyspnea, apathy, staggering, tonus with stretching, yellow/orange colored urine, piloerection in females, poor general state in males and femals (non-GLP, non-guideline, 1982)   Read-across from CAS 36888-99-0: Key: dermal, rat: LD50 > 2500 mg/kg bw; transient signs of toxicity: no abnormality detected (non-GLP, similar to OECD 402, 1973) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d33b90a-86fc-4809-b67c-7fbcb3215a47/documents/IUC5-1294132b-20b5-44e7-8b9f-7b3751281a4c_b78f3373-ff9e-4f55-9a99-3017f80f15d3.html,,,,,, "2-cyano-2-[2,3-dihydro-3-(tetrahydro-2,4,6-trioxo-5(2H)-pyrimidinylidene)-1H-isoindol-1-ylidene]-N-methylacetamide",76199-85-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d33b90a-86fc-4809-b67c-7fbcb3215a47/documents/IUC5-1294132b-20b5-44e7-8b9f-7b3751281a4c_b78f3373-ff9e-4f55-9a99-3017f80f15d3.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2-cyano-2-[2,3-dihydro-3-(tetrahydro-2,4,6-trioxo-5(2H)-pyrimidinylidene)-1H-isoindol-1-ylidene]-N-methylacetamide",76199-85-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d33b90a-86fc-4809-b67c-7fbcb3215a47/documents/IUC5-1294132b-20b5-44e7-8b9f-7b3751281a4c_b78f3373-ff9e-4f55-9a99-3017f80f15d3.html,,inhalation,discriminating conc.,"5,420 mg/m3",no adverse effect observed, 2-cyano-N-methylacetamide,6330-25-2,"The acute oral toxicity of 2 -cyano-N-methylacetamide was investigated in male and female rats according to a procedure similar to OECD testing guideline 423. Doses of 215 mg/kg bw, 316 mg/kg bw, 681 mg/kg bw, 1000 mg/kg bw, 1470 mg/kg bw and 2150 mg/kw bw were applied to 5 animals per sex per dose. The main symptoms of intoxication were dyspnea, apathy, abnormal body positions, staggering, tonic cramps, ruffled haircoat, skin redness, hypohydration and a general bad condition of the animals, starting at the lowese dose level partially already 15 min after application. The substance produced a variety of systemic effects. All male animals (as well as one female rat) died in the dose group of 681 mg/kg bw. Due to this results, the oral toxicity is characterised by a LD50 value of 681 mg/kg bw for both male and female rats together. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79af416b-f97d-4278-9bfa-e2f18b9386e0/documents/IUC5-eb5625c2-9679-451f-86df-f27b6e8c3d7b_70e42b92-831d-43cf-b853-ad776b51b6a6.html,,,,,, 2-cyano-N-methylacetamide,6330-25-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79af416b-f97d-4278-9bfa-e2f18b9386e0/documents/IUC5-eb5625c2-9679-451f-86df-f27b6e8c3d7b_70e42b92-831d-43cf-b853-ad776b51b6a6.html,,oral,LD50,681 mg/kg bw,, 2-methyl-5-propylcyclohex-2-en-1-one,1447712-18-6,Acute oral toxicity: LD50 cut off value ≥ 5000 mg/kg bw (OECD 423; GLP compliant) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/661ce745-a634-48eb-bc1b-68f9ea8ec9bf/documents/IUC5-9cf71b91-78c9-4d90-9ca8-d3b39e7a901c_6414f7cd-3044-4aba-a272-49a114ac99d4.html,,,,,, 2-methyl-5-propylcyclohex-2-en-1-one,1447712-18-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/661ce745-a634-48eb-bc1b-68f9ea8ec9bf/documents/IUC5-9cf71b91-78c9-4d90-9ca8-d3b39e7a901c_6414f7cd-3044-4aba-a272-49a114ac99d4.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, ethyl cyclopent-2-en-1-ylacetate,15848-49-4,Acute Oral Toxicity: LD50 = 2510 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe1aa1a1-d8a5-4e14-abd5-dc603f0ef515/documents/IUC5-e83edb04-49e1-4031-9866-839891eb7367_ab676a79-3874-4cd2-8238-5bba990fefd4.html,,,,,, ethyl cyclopent-2-en-1-ylacetate,15848-49-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe1aa1a1-d8a5-4e14-abd5-dc603f0ef515/documents/IUC5-e83edb04-49e1-4031-9866-839891eb7367_ab676a79-3874-4cd2-8238-5bba990fefd4.html,,oral,LD50,"2,510 mg/kg bw",no adverse effect observed, Deoxyribose-phosphate aldolase EC 4.1.2.4.,9026-97-5,"LD50 (oral,rat) > 2000 mg/kg (OECD 423, GLP) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a32df7fd-9688-4ab4-867c-d224c1386494/documents/IUC5-410d0372-61bd-4076-a94d-12d9396f4272_306b1812-808c-42ba-beb3-33821c2c6064.html,,,,,, "2-Dibenzofuranyl-1-4,6-diphenyl-[1,3,5]-triazine",1822310-42-8, GLP compliant OECD 423: LD50 (oral) > 2000 mg/kg bw ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bca235f-f86f-4bc5-829b-3a2f0c25d847/documents/f175cd0d-412a-4271-b341-731813477916_f0ee794d-b542-4079-9ded-f6ad14869cfe.html,,,,,, "2-Dibenzofuranyl-1-4,6-diphenyl-[1,3,5]-triazine",1822310-42-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bca235f-f86f-4bc5-829b-3a2f0c25d847/documents/f175cd0d-412a-4271-b341-731813477916_f0ee794d-b542-4079-9ded-f6ad14869cfe.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-dodecylhexadecan-1-ol,72388-18-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af29ff1b-04f9-40af-8b29-72817b1a7fb2/documents/IUC5-36049875-f5e1-47ac-b5f8-e8e3bed7dec5_1a0c28d2-693d-417a-80f3-ae2e3955f028.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,839.6 mg/kg bw/day,, 2-dodecylhexadecan-1-ol,72388-18-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af29ff1b-04f9-40af-8b29-72817b1a7fb2/documents/IUC5-78f0c5fd-9a33-4510-b92b-71a3083727ac_1a0c28d2-693d-417a-80f3-ae2e3955f028.html,,oral,LD50,"32,200 mg/kg bw",no adverse effect observed, 2-dodecylhexadecan-1-ol,72388-18-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af29ff1b-04f9-40af-8b29-72817b1a7fb2/documents/IUC5-78f0c5fd-9a33-4510-b92b-71a3083727ac_1a0c28d2-693d-417a-80f3-ae2e3955f028.html,,dermal,discriminating dose,"1,674 mg/kg bw",no adverse effect observed, "Reaction mass of REL-(1S,2R,6S)-2,6-dimethylcyclohexyl ethyl ether and MESO-(2R,6R)-2,6-dimethylcyclohexyl ethyl ether",286472-48-8, Based on these results a parental NOAEL for systemic effects of 500 mg/kg bw/d was derived. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ed65430-6649-4427-87dd-698c79cc7f84/documents/2c4bed20-052b-4732-98e3-73a5c4c937ed_0b29ed50-70f0-4f76-9e40-3cf70db18031.html,,,,,, "Reaction mass of REL-(1S,2R,6S)-2,6-dimethylcyclohexyl ethyl ether and MESO-(2R,6R)-2,6-dimethylcyclohexyl ethyl ether",286472-48-8, Acute oral toxicity: OECD TG 423: LD50 > 2000 mg/kg bw Acute dermal toxicity: OECD TG 402: LD50 > 2000 mg/kg bw Acute inhalation toxicity: OECD 403: LC50 > 5.05 g/m3 ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ed65430-6649-4427-87dd-698c79cc7f84/documents/da8d466e-b33d-4513-94c3-58c1ce55aa49_0b29ed50-70f0-4f76-9e40-3cf70db18031.html,,,,,, "Reaction mass of REL-(1S,2R,6S)-2,6-dimethylcyclohexyl ethyl ether and MESO-(2R,6R)-2,6-dimethylcyclohexyl ethyl ether",286472-48-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ed65430-6649-4427-87dd-698c79cc7f84/documents/da8d466e-b33d-4513-94c3-58c1ce55aa49_0b29ed50-70f0-4f76-9e40-3cf70db18031.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction mass of REL-(1S,2R,6S)-2,6-dimethylcyclohexyl ethyl ether and MESO-(2R,6R)-2,6-dimethylcyclohexyl ethyl ether",286472-48-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ed65430-6649-4427-87dd-698c79cc7f84/documents/da8d466e-b33d-4513-94c3-58c1ce55aa49_0b29ed50-70f0-4f76-9e40-3cf70db18031.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction mass of REL-(1S,2R,6S)-2,6-dimethylcyclohexyl ethyl ether and MESO-(2R,6R)-2,6-dimethylcyclohexyl ethyl ether",286472-48-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ed65430-6649-4427-87dd-698c79cc7f84/documents/da8d466e-b33d-4513-94c3-58c1ce55aa49_0b29ed50-70f0-4f76-9e40-3cf70db18031.html,,inhalation,LC50,"5,020 mg/m3",no adverse effect observed, 2-ethoxy-1-methylethyl acetate,54839-24-6,Oral: NOAEL (10 day) <2ml/kg (1880mg/kg)Inhalation: NOAEC (28 day) >7.2mg/l. NOAEC (90 day extrapolated from surrogate)=1.8mg/lDermal: NOAEC(90 day extrapolated from surrogate) = 2920mg/kg ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b693ec1-0f2d-43f0-8b24-df0472d721b8/documents/IUC5-8552deb3-9685-4915-891e-2162c4ffd91b_b2d25753-19c1-415d-8aea-39ac45949198.html,,,,,, 2-ethoxy-1-methylethyl acetate,54839-24-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b693ec1-0f2d-43f0-8b24-df0472d721b8/documents/IUC5-8552deb3-9685-4915-891e-2162c4ffd91b_b2d25753-19c1-415d-8aea-39ac45949198.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,920 mg/kg bw/day",,rat 2-ethoxy-1-methylethyl acetate,54839-24-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b693ec1-0f2d-43f0-8b24-df0472d721b8/documents/IUC5-8552deb3-9685-4915-891e-2162c4ffd91b_b2d25753-19c1-415d-8aea-39ac45949198.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,800 mg/m3",,rat 2-ethoxy-1-methylethyl acetate,54839-24-6,"LC50 (oral) > 5000mg/kgLDL0 (inhalation, 4hrs) > 6.99mg/lLC50 (dermal) ~ 20,000mg/kg (prediction based on surrogate substance) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b693ec1-0f2d-43f0-8b24-df0472d721b8/documents/IUC5-3e91a338-769d-493c-b3a8-79484b9ddbcd_b2d25753-19c1-415d-8aea-39ac45949198.html,,,,,, 2-ethoxy-2-methylpropane,637-92-3,"Regarding oral exposure, results of chronic oral (drinking water) studies demonstrate alterations in clinical chemistry parameters in male and female rats with a NOAEL of 121 mg/kg bw/day. This NOAEL is quite conservative given the occurrence of reduced water consumption (and probable dehydration) noted in the higher treatment groups, an observation considered related to the unpleasant taste of ETBE.The key studies for DNEL derivation for long term inhalation exposure are the 90 day and 2 year studies in rodents. The overall NOAEC was 500 ppm (2100 mg/m3) based on liver effects after sub-chronic exposure (mainly female mice, 1750 and 5000 ppm (7350 and 21000 mg/m3)) and reduced survival, slight haematological changes, altered clinical chemistry parameters and liver effects (increased relative weight, bile duct hyperplasia) (rats, 1500 and 5000 ppm (6300 and 21000 mg/m3)) after chronic exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1e73770-80c6-4004-9ad6-d6048de72bf0/documents/IUC5-e0d7163f-e1dc-4883-a0cf-7ee4499a92b9_8da1d0b8-b3cc-4237-9e02-20658815b7bb.html,,,,,, 2-ethoxy-2-methylpropane,637-92-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1e73770-80c6-4004-9ad6-d6048de72bf0/documents/IUC5-e0d7163f-e1dc-4883-a0cf-7ee4499a92b9_8da1d0b8-b3cc-4237-9e02-20658815b7bb.html,Chronic toxicity – systemic effects,oral,NOAEL,121 mg/kg bw/day,,rat 2-ethoxy-2-methylpropane,637-92-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1e73770-80c6-4004-9ad6-d6048de72bf0/documents/IUC5-e0d7163f-e1dc-4883-a0cf-7ee4499a92b9_8da1d0b8-b3cc-4237-9e02-20658815b7bb.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"2,100 mg/m3",,rat 2-ethoxy-2-methylpropane,637-92-3,"The acute toxicity of ETBE is low. The oral and dermal LD50 values in rats and rabbits were >2000 mg/kg bw (both routes of exposure). In an inhalation study with rats, a LC50 value of > 5.88 mg/l was obtained. This result is confirmed by White et al (1995) (28 day inhalation study with rats, maximal concentration 16.8 mg/l, no mortality) and CIIT (1996a,b) (90 day inhalation studies with rats and mice, maximal concentration 21 mg/l, no mortality).Limited human data showed that exposure to 25 and 50 ppm ETBE vapour for 2 hr was associated with slightly decreased lung function. However, the changes were mild in nature and minor in extent, and reflect normal variation that is of no clinical significance. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1e73770-80c6-4004-9ad6-d6048de72bf0/documents/IUC5-af8697e7-fca8-442c-ae2d-71197b9ee5a1_8da1d0b8-b3cc-4237-9e02-20658815b7bb.html,,,,,, 2'-ethoxy-3-hydroxy-2-naphthanilide,92-74-0,Administration of 5000 mg/kg bw of Naphtol AS PH to female rats did not cause any adverse effects. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7688186-f264-49b1-9d8a-fd372a641901/documents/IUC5-b766b3d4-98ad-4f17-a486-7f3b96b9d12d_43c02b0c-41c6-4513-af17-e12190ed023b.html,,,,,, 2-ethoxy-4-(ethoxymethyl)phenol,71119-07-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The key study is GLP compliant and of high quality (Klimisch score = 1) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/895439cd-6f45-46ec-ae5c-6ec72b1f6797/documents/c4d66a28-10f9-490f-8add-99d7cf9139f2_18d3f24f-cd16-4251-baec-4bdf4502fb52.html,,,,,, 2-ethoxy-4-(ethoxymethyl)phenol,71119-07-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/895439cd-6f45-46ec-ae5c-6ec72b1f6797/documents/c4d66a28-10f9-490f-8add-99d7cf9139f2_18d3f24f-cd16-4251-baec-4bdf4502fb52.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-ethoxybenzonitrile,6609-57-0,"Ethoxybenzonitril is harmful after single oral exposure (LD50 cut-off, rat: > 500 - < 1000 mg/kg bw). ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d58ada7-6ff3-4e20-bd42-d959836782d3/documents/IUC5-d683a6b9-cf4e-4113-83eb-eada3ea07a11_f7de8fc4-54c0-483c-84db-8d1724c9f6d2.html,,,,,, 2-ethoxyethyl ethyl carbonic acid ester,627034-93-9," Acute Oral Toxicity Under the conditions of the study, the acute oral LD50 value of the test material was found to be above 2000 mg/kg bw in female RccHan:(WIST) rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9849c941-f483-4b35-941e-d8ddaac08da4/documents/860133a5-21ad-4795-a062-447bd99c8490_31ed5aa1-c390-4041-a74a-d0174581749f.html,,,,,, 2-ethoxyethyl methacrylate,2370-63-0, subchronic NOAEL = 163 mg/kg bw/d (rat) (read-across from 2-ethoxyethanol) ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/755fb159-a373-4501-8ff4-9513a1b1cefa/documents/IUC5-75ce88a6-ae70-4ad5-95dd-3c593cd3528f_34fa3903-6751-4960-b359-7e4553e8ebf0.html,,,,,, 2-ethoxyethyl methacrylate,2370-63-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/755fb159-a373-4501-8ff4-9513a1b1cefa/documents/IUC5-75ce88a6-ae70-4ad5-95dd-3c593cd3528f_34fa3903-6751-4960-b359-7e4553e8ebf0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,163 mg/kg bw/day,,rat 2-ethoxyethyl methacrylate,2370-63-0,"Acute oral toxicity:Oral LD50 (rat, male/female) > 2000 mg/kg bw; OECD Guideline 401; GLP compliant, RL1Supporting studies:Oral LD50 (mouse, male/female) > 8200 mg/kg bw (95% c.i. 5200 – 13300 mg/kg bw); equivalent to OECD Guideline 401; pre-GLP, RL2 (Basic data given: comparable to guidelines)Oral LD50 (rat, sex not given) > 5000 mg/kg bw; pre-GLP, RL3 (Documentation insufficient for assessment)Acute dermal toxicity:Dermal LD50 (rat, male/female) > 2000 mg/kg bw; OECD Guideline 402; GLP compliant, RL1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/755fb159-a373-4501-8ff4-9513a1b1cefa/documents/IUC5-0d797476-901e-47c4-8897-fcd504f0ba2e_34fa3903-6751-4960-b359-7e4553e8ebf0.html,,,,,, 2-ethoxyethyl methacrylate,2370-63-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/755fb159-a373-4501-8ff4-9513a1b1cefa/documents/IUC5-0d797476-901e-47c4-8897-fcd504f0ba2e_34fa3903-6751-4960-b359-7e4553e8ebf0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-ethoxyethyl methacrylate,2370-63-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/755fb159-a373-4501-8ff4-9513a1b1cefa/documents/IUC5-0d797476-901e-47c4-8897-fcd504f0ba2e_34fa3903-6751-4960-b359-7e4553e8ebf0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-ethoxyethyl-2-(4-(2,6-dihydro-2,6-dioxo-7-phenyl-1,5-dioxaindacen-3-yl)phenoxy)acetate",147014-52-6,"One oral acute toxicity study was performed on rats. There were no death and, no signficant signs of toxicity were seen in any of the animals. The estimated oral median lethal dose was in excess of 2000 mg/kg to both male and female rats. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d101448-413d-4239-8b69-dead0537f8af/documents/IUC5-8fdd9548-76e7-4ed1-a62b-a09fcedde11b_8833ecb2-02a1-4149-80ee-8b404d3e7c26.html,,,,,, "2-ethoxyethyl-2-(4-(2,6-dihydro-2,6-dioxo-7-phenyl-1,5-dioxaindacen-3-yl)phenoxy)acetate",147014-52-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d101448-413d-4239-8b69-dead0537f8af/documents/IUC5-8fdd9548-76e7-4ed1-a62b-a09fcedde11b_8833ecb2-02a1-4149-80ee-8b404d3e7c26.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-ethoxy-N-hydroxybenzenecarboximidamide,879-57-2,"Imidoxim is harmful after single oral exposure (LD50 cut-off, rat: > 300 - < 500 mg/kg bw) (Krötlinger, 2000). ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1fcdf84-e5fb-4d91-9bb8-61fb95d7df44/documents/IUC5-4f6df8e1-d7be-43dd-93ec-3f36615239dd_fffb6a8c-5865-4f77-9fe6-8407f6d39f55.html,,,,,, 2-ethoxyphenol,94-71-3,"LD50 oral (rat) > 2000 mg/kg, based on available studies. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a53e194d-9fa2-48e8-ac0e-6ce2c7509241/documents/IUC5-da23365f-29d6-43e8-8d34-d4bbe8faabc3_f87f6bc4-ca18-4c0d-a0e5-c431ac3df890.html,,,,,, "2-ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate",25111-05-1,The available subchronic repeated dose oral toxicity studies resulted in NOAEL of 1000 mg/kg bw/day or greater. ,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d4a626f-c8dc-462b-86c4-e6f0cd9521e9/documents/IUC5-cc8c83c0-abda-462c-bc7b-9ad5a0219a72_9cb5bfe6-21e4-4bb5-b5dc-865501914690.html,,,,,, "2-ethyl-2-(hydroxymethyl)-1,3-propanediyl dioleate",25111-05-1,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401 and 423, GLP, analogue approach)Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, GLP, analogue approach)Acute toxicity: Inhalation LC50 (rat, m/f): > 5.22 mg/mL (OECD 436, GLP, analogue approach) ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d4a626f-c8dc-462b-86c4-e6f0cd9521e9/documents/IUC5-4612d562-5379-4e65-ab07-92020603c8d0_9cb5bfe6-21e4-4bb5-b5dc-865501914690.html,,,,,, "2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate",78-16-0,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category. All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6eed0c1a-fa00-4e1f-8cd7-3d44645fad62/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_1f16e7a7-373c-43dc-a813-f09f9d58844f.html,,,,,, "2-ethyl-2-[[(1-oxoheptyl)oxy]methyl]propane-1,3-diyl bisheptanoate",78-16-0,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6eed0c1a-fa00-4e1f-8cd7-3d44645fad62/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_1f16e7a7-373c-43dc-a813-f09f9d58844f.html,,,,,, "2-ethyl-2-[[(1-oxononyl)oxy]methyl]propane-1,3-diyl dinonan-1-oate",126-57-8,A NOAEL of 1000 mg/kg bw/d was determined for the test item based on effects observed in a combined repeated dose / reprotox screening test (OECD422). ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/59f8bbae-5ea5-4592-b331-a2c02d95d9d5/documents/IUC5-0e9af80c-9e1f-45b8-b402-325150e004f8_c751ef31-53e2-4c92-9eb8-6c3e906a88b2.html,,,,,, "2-ethyl-2-[[(1-oxononyl)oxy]methyl]propane-1,3-diyl dinonan-1-oate",126-57-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/59f8bbae-5ea5-4592-b331-a2c02d95d9d5/documents/IUC5-0e9af80c-9e1f-45b8-b402-325150e004f8_c751ef31-53e2-4c92-9eb8-6c3e906a88b2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-ethyl-2-[[(1-oxononyl)oxy]methyl]propane-1,3-diyl dinonan-1-oate",126-57-8,"Two recent GLP studies that were performed according to OECD guidelines are present for acute toxicity oral and acute toxicity dermal (Salvador, 2014 and 2014a). Both studies did not show any adverse effects up to a concentration of 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59f8bbae-5ea5-4592-b331-a2c02d95d9d5/documents/IUC5-f1df08d7-899c-46fa-a6dd-b862ff9b902a_c751ef31-53e2-4c92-9eb8-6c3e906a88b2.html,,,,,, "2-ethyl-2-[[(1-oxononyl)oxy]methyl]propane-1,3-diyl dinonan-1-oate",126-57-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59f8bbae-5ea5-4592-b331-a2c02d95d9d5/documents/IUC5-f1df08d7-899c-46fa-a6dd-b862ff9b902a_c751ef31-53e2-4c92-9eb8-6c3e906a88b2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-ethyl-2-[[(1-oxononyl)oxy]methyl]propane-1,3-diyl dinonan-1-oate",126-57-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59f8bbae-5ea5-4592-b331-a2c02d95d9d5/documents/IUC5-f1df08d7-899c-46fa-a6dd-b862ff9b902a_c751ef31-53e2-4c92-9eb8-6c3e906a88b2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-ethyl-2-oxazoline,10431-98-8," No test data to address repeated dose toxicity of the target substance is available. Therefore, information for 2-aminoethanol and propionic acid are presented to address this endpoint. A sub-chronic repeated dose rat toxicity study reported a 90-day (oral gavage) NOAEL of 320 mg/kg bw/day and a LOAEL of 640 mg/kg bw/day for 2-aminoethanol due to altered liver or kidney weight.  In a sub-chronic repeated dose dog toxicity study, propionic acid up to 3% in the diet induced epithelial hyperplasia which appeared at multiple levels of the esophagus with a NOAEL at 1% (0.660 - 0.835 g/kg bw/day (males); 0.696 - 0.844 g/kg bw/day (females)).  As such, based on these values, the NOAEL of the target substance would be a sub-chronic value of 520 mg/kg bw/day based on 2-aminoethanol and sub-chronic value of 917 mg/kg bw/day based on the propionic acid. For the purposes of risk assessment, the sub-chronic NOAEL of 0.52 g/kg bw/day will be utilized, as this value derives the more protective PNECoral and DNELs values. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64593eaf-a960-49b8-9b79-ca568118b194/documents/0c71b7cf-3ceb-405e-8945-16d790c8bef1_0a7f2d7e-6e6c-4799-9973-4790d3ff3c96.html,,,,,, 2-ethyl-2-oxazoline,10431-98-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64593eaf-a960-49b8-9b79-ca568118b194/documents/0c71b7cf-3ceb-405e-8945-16d790c8bef1_0a7f2d7e-6e6c-4799-9973-4790d3ff3c96.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,520 mg/kg bw/day,,rat 2-ethyl-2-oxazoline,10431-98-8, Two acute oral studies have been conducted. One study reported the acute LD50 for males and females is reported as 2940 mg/kg bw. The other study reported the LD50 for female rats was calculated to be 2700 mg/kg bw; the LD50 for male rats was 3660 mg/kg bw. Both studies indicate that ETOX is a UN GHS Category 5 acute oral hazard. Neither study reported clinical signs or gross pathological findings that would indicate specific organ toxicity following single exposure.   Male rats were exposed to 635 ppm (measured concentration) ETOX vapour via whole body exposure. No mortality was reported. No toxicologically significant gross pathological findings were reported. The 7-hour LC50 is >635 ppm.   No deaths were reported following unabraded dermal exposure of 2 male and 2 female rabbits to 500 mg/kg bw active material presented as a 10% aqueous solution of ETOX. The dermal acute LD50 is >500 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64593eaf-a960-49b8-9b79-ca568118b194/documents/abf1599a-9d7f-4d63-a458-a648598cf7ab_0a7f2d7e-6e6c-4799-9973-4790d3ff3c96.html,,,,,, 2-ethyl-2-oxazoline,10431-98-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64593eaf-a960-49b8-9b79-ca568118b194/documents/abf1599a-9d7f-4d63-a458-a648598cf7ab_0a7f2d7e-6e6c-4799-9973-4790d3ff3c96.html,,oral,LD50,"2,700 mg/kg bw",adverse effect observed, 2-ethyl-4-methylimidazole,931-36-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/52ad773d-313a-4938-9fb6-c0ca8ae73f80/documents/IUC5-103dd5d7-9ed5-43ec-bd47-a6dda2dfe95f_a7953711-784a-4b85-8f3e-bbc0e9cce456.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat 2-ethyl-4-methylimidazole,931-36-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52ad773d-313a-4938-9fb6-c0ca8ae73f80/documents/IUC5-80c63192-26a7-449b-ace8-21bf8d613e1d_a7953711-784a-4b85-8f3e-bbc0e9cce456.html,,oral,LD50,731 mg/kg bw,adverse effect observed, 2-ethyl-4-methylimidazole,931-36-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52ad773d-313a-4938-9fb6-c0ca8ae73f80/documents/IUC5-80c63192-26a7-449b-ace8-21bf8d613e1d_a7953711-784a-4b85-8f3e-bbc0e9cce456.html,,dermal,discriminating dose,400 mg/kg bw,no adverse effect observed, 2-ethyl-4-methylimidazole,931-36-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52ad773d-313a-4938-9fb6-c0ca8ae73f80/documents/IUC5-80c63192-26a7-449b-ace8-21bf8d613e1d_a7953711-784a-4b85-8f3e-bbc0e9cce456.html,,inhalation,discriminating conc.,30 mg/m3,no adverse effect observed, 2-ethylaniline,578-54-1," 2-ethylaniline has got a not negligible acute toxicity: oral LD50 rat = 1260 mg/kg/bw, dermal LD50 rabbit = 840 mg/kg/bw and inhalation LD0 rat = 1.07 mg/l (220 ppm) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34d7a63a-25ae-41b0-9bdb-757701ecf86b/documents/db1bc12a-a604-4bae-9dda-fabc8c76938c_7cd4520c-0edc-4f48-81c4-cd6b6a8a4af7.html,,,,,, 2-ethylaniline,578-54-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34d7a63a-25ae-41b0-9bdb-757701ecf86b/documents/db1bc12a-a604-4bae-9dda-fabc8c76938c_7cd4520c-0edc-4f48-81c4-cd6b6a8a4af7.html,,oral,LD50,"1,260 mg/kg bw",adverse effect observed, 2-ethylaniline,578-54-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34d7a63a-25ae-41b0-9bdb-757701ecf86b/documents/db1bc12a-a604-4bae-9dda-fabc8c76938c_7cd4520c-0edc-4f48-81c4-cd6b6a8a4af7.html,,dermal,LD50,840 mg/kg bw,adverse effect observed, 2-ethylanthraquinone,84-51-5," The NOAEL of 20 mg/kg bw is based on adverse clinical pathological findings at next higher dose (reduced body weight gain, reduced food consumption in females, changes in haematology, increased extramedullary hemopoiesis in spleen, increased spleen weight, increase bile acid in males and total protein in females). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6d0d03a-22d9-48eb-87bf-ea3001e5d657/documents/IUC5-3414a52e-34e8-4530-8b33-e25c3194cffc_ebe78b4d-7f44-40de-9075-0cafc8134a48.html,,,,,, 2-ethylanthraquinone,84-51-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6d0d03a-22d9-48eb-87bf-ea3001e5d657/documents/IUC5-3414a52e-34e8-4530-8b33-e25c3194cffc_ebe78b4d-7f44-40de-9075-0cafc8134a48.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat 2-ethylanthraquinone,84-51-5,Three acute oral toxicity studies in rats and one acute dermal toxicity study in rabbits are available. The LD50 was above 2000 mg/kg bw in all studies. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6d0d03a-22d9-48eb-87bf-ea3001e5d657/documents/IUC5-46eeeb08-d55a-4846-b520-4080c4a11e18_ebe78b4d-7f44-40de-9075-0cafc8134a48.html,,,,,, "2-ethylhexanoic acid, cerium salt",24593-34-8,"No repeated dose toxicity study with 2-ethylhexanoic acid, cerium salt is available, thus, the repeated dose toxicity will be addressed with existing data on the individual assessment entities cerium and 2-ethylhexanoate. In relevant and reliable repeated dose toxicity studies for both assessment entities of 2-ethylhexanoic acid, cerium salt, there were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/981a18f5-8674-4dbf-a34a-5b292fa522f3/documents/689c849f-e597-4438-875e-4f0074f33cec_73012350-655f-485c-9326-85ef5196a12b.html,,,,,, "2-ethylhexanoic acid, cerium salt",24593-34-8,"The experimentally measured oral LD50 for 2-ethylhexanoic acid, cerium salt is > 2000 mg/kg bw, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral toxicity as well as for specific target organ toxicity, single exposure (STOT SE). Signs of acute dermal toxicity are not expected for 2-ethylhexanoic acid, cerium salt, since the two moieties cerium and 2-ethylhexanoic acid have not shown signs of acute dermal toxicity in experimental testing (both LD50 > 2000 mg/kg bw). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/981a18f5-8674-4dbf-a34a-5b292fa522f3/documents/afe2cb0e-b854-43a4-beb2-4c08febd2875_73012350-655f-485c-9326-85ef5196a12b.html,,,,,, "2-ethylhexanoic acid, cerium salt",24593-34-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/981a18f5-8674-4dbf-a34a-5b292fa522f3/documents/afe2cb0e-b854-43a4-beb2-4c08febd2875_73012350-655f-485c-9326-85ef5196a12b.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)",74931-55-8," An assessment was undertaken based on available data on the individual constituents of the substance. A NOAEL of 300 mg/kg bw/d is proposed for the short-term repeated-dose toxicity of 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) via the oral route. This value is considered as conservative. The substance does not induce specific target organ toxicity. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/935b728d-6d8d-4d60-a498-deb53da74ac1/documents/60f05142-3f14-4359-8b55-e46f3e733c36_8f07e4f2-b393-405e-ae22-26fdab2e5fa2.html,,,,,, "2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)",74931-55-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/935b728d-6d8d-4d60-a498-deb53da74ac1/documents/60f05142-3f14-4359-8b55-e46f3e733c36_8f07e4f2-b393-405e-ae22-26fdab2e5fa2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2-ethylhexanoic acid, compound with 2-aminoethanol (1:1)",74931-55-8," In accordance with Annex VII and Annex VIII of REACH, Column 2, the acute toxicity does not need to be investigated as 2-ethylhexanoic acid, compound with 2-aminoethanol (1:1) is classified as corrosive to the skin. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/935b728d-6d8d-4d60-a498-deb53da74ac1/documents/683bc910-3506-4e43-94af-960d0d764a0d_8f07e4f2-b393-405e-ae22-26fdab2e5fa2.html,,,,,, "2-ethylhexanoic acid, copper salt",22221-10-9," No repeated dose toxicity study with 2-ethylhexanoic acid, copper salt is available, thus the repeated dose toxicity will be addressed with existing data on the individual assessment entities copper and 2-ethylhexanoic acid. In relevant and reliable repeated dose toxicity studies for both moieties of 2-ethylhexanoic acid, copper salt, toxicological relevant findings were observed in repeated dose toxicity studies with copper. No adverse effects were observed for the moiety 2-ethylhexanoic acid. Classification criteria are not met since no severe adverse effects were observed at the guidance value, oral for a Category 1 classification of 10 mg/kg bw/day and at the guidance value for a Category 2 classification of 100 mg/kg bw/day, hence no classification required. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9263f673-ff5a-434c-b14f-2dacff2f3344/documents/eb9fe67c-be62-4553-b9f0-2be47448ee54_3f155892-f580-4905-a61e-cbba228c10d3.html,,,,,, "2-ethylhexanoic acid, copper salt",22221-10-9,"In a GLP conform OECD 423 study, the acute oral LD50 value of the test item Copper bis(2-ethylhexanoate) was found to be LD50 > 2000 mg/kg bw in female Han:WIST rats. Therefore, the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral toxicity as well as for specific target organ toxicity, single exposure (STOT SE). Signs of dermal toxicity are not expected for the moiety 2-ethylhexanoic acid, since the LD50 is greater than 2000 mg/kg bw. The dermal LD50 value for copper is also >2000 mg Cu/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9263f673-ff5a-434c-b14f-2dacff2f3344/documents/c54887dc-e3c1-492d-8f92-8a2147bb788f_3f155892-f580-4905-a61e-cbba228c10d3.html,,,,,, "2-ethylhexanoic acid, copper salt",22221-10-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9263f673-ff5a-434c-b14f-2dacff2f3344/documents/c54887dc-e3c1-492d-8f92-8a2147bb788f_3f155892-f580-4905-a61e-cbba228c10d3.html,,oral,LD50,"> 2,000 mg/kg bw",adverse effect observed, "2-ethylhexanoic acid, iron salt",19583-54-1,"No repeated dose toxicity study with 2-ethylhexanoic acid, iron salt is available, thus, the repeated dose toxicity will be addressed with existing data on the individual moieties iron and 2-ethylhexanoate. Considering the role of iron in human metabolic processes, it is highlighted that iron has several vital functions in the body and is an essential nutrient for humans. Additionally, no adverse effects were observed for the moiety 2-ethylhexanoic acid. According to the criteria of REGULATION (EC) No 1272/2008 and its subsequent adaptions, 2-ethylhexanoic acid, iron salt does neither have to be classified and has no obligatory labelling requirement for repeated oral toxicity nor for specific target organ toxicity after repeated exposure (STOT RE). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/175d4da5-e451-4780-a8ed-a60877dc2484/documents/1976045d-e144-47ff-9d6d-7733eba4dc28_d5322d0e-6c67-4e35-ab18-74bb5fbfa0b8.html,,,,,, "2-ethylhexanoic acid, iron salt",19583-54-1,"The experimentally measured oral LD50 for 2-ethylhexanoic, iron salt is > 2000 mg/kg bw, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral toxicity as well as for specific target organ toxicity, single exposure (STOT SE). No adverse effects were observed upon acute dermal exposure for both assessment entities iron and 2-ethylhexanoic acid, thus the calculated LD50 is >2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/175d4da5-e451-4780-a8ed-a60877dc2484/documents/47a5e3a5-cfe6-4261-ba8b-2dc793315281_d5322d0e-6c67-4e35-ab18-74bb5fbfa0b8.html,,,,,, "2-ethylhexanoic acid, iron salt",19583-54-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/175d4da5-e451-4780-a8ed-a60877dc2484/documents/47a5e3a5-cfe6-4261-ba8b-2dc793315281_d5322d0e-6c67-4e35-ab18-74bb5fbfa0b8.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2-ethylhexanoic acid, manganese salt",15956-58-8,"No repeated dose toxicity study with 2-ethylhexanoic acid, manganese salt is available, thus, the repeated dose toxicity will be addressed with existing data on the individual moieties manganese and 2-ethylhexanoate. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1391f0d5-589e-4044-a432-3f402069a634/documents/IUC5-730e7e97-61f7-4e63-b3fa-dd43772ba78e_f03db794-6bd4-479f-8559-04cf5eb64dd1.html,,,,,, "2-ethylhexanoic acid, manganese salt",15956-58-8,"The experimentally measured oral LD50 for 2-ethylhexanoic, manganese salt is > 2000 mg/kg bw, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral toxicity as well as for specific target organ toxicity, single exposure (STOT SE). No adverse effects were observed upon acute dermal exposure for both assessment entities manganese and 2-ethylhexanoic acid, thus the calculated LD50 is >2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1391f0d5-589e-4044-a432-3f402069a634/documents/IUC5-e0388f92-93a5-4d3d-b7fc-e6e4f9ca13fd_f03db794-6bd4-479f-8559-04cf5eb64dd1.html,,,,,, "2-ethylhexanoic acid, manganese salt",15956-58-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1391f0d5-589e-4044-a432-3f402069a634/documents/IUC5-e0388f92-93a5-4d3d-b7fc-e6e4f9ca13fd_f03db794-6bd4-479f-8559-04cf5eb64dd1.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2-ethylhexanoic acid, molybdenum salt",34041-09-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcb7a289-bc9f-4868-98dd-e32fcd40329b/documents/IUC5-b90ced3c-d0c3-4be4-8d98-636a3c3c1938_9a56d770-619b-417e-b237-cde132bd8526.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2-ethylhexanoic acid, monoester with propane-1,2-diol",85114-00-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The key study is GLP compliant and is of high quality (Klimisch score=1) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98769656-2689-4e31-8e09-a80ab233dfe6/documents/17244070-fb76-46b0-8603-3be0ef5b7132_6e0d4ca4-5665-4789-bbc7-59a3a787168e.html,,,,,, "2-ethylhexanoic acid, monoester with propane-1,2-diol",85114-00-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98769656-2689-4e31-8e09-a80ab233dfe6/documents/17244070-fb76-46b0-8603-3be0ef5b7132_6e0d4ca4-5665-4789-bbc7-59a3a787168e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "2-ethylhexanoic acid, monoester with propane-1,2-diol",85114-00-7,The substance is of low acute toxicity in mammals by both the oral and dermal routes. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98769656-2689-4e31-8e09-a80ab233dfe6/documents/79b84f80-d9a5-4fb7-981e-a73b26109dc1_6e0d4ca4-5665-4789-bbc7-59a3a787168e.html,,,,,, "2-ethylhexanoic acid, monoester with propane-1,2-diol",85114-00-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98769656-2689-4e31-8e09-a80ab233dfe6/documents/79b84f80-d9a5-4fb7-981e-a73b26109dc1_6e0d4ca4-5665-4789-bbc7-59a3a787168e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-ethylhexanoic acid, monoester with propane-1,2-diol",85114-00-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98769656-2689-4e31-8e09-a80ab233dfe6/documents/79b84f80-d9a5-4fb7-981e-a73b26109dc1_6e0d4ca4-5665-4789-bbc7-59a3a787168e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-ethylhexanoic acid, zirconium salt",22464-99-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1eae920-2176-4005-9840-ab34caf8a80c/documents/IUC5-958af7fb-c176-4da7-901a-9246fe0fbf7e_ae6b0972-7fa1-4765-bcf9-3c41dcc57220.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-ethylhexanoyl chloride,760-67-8,"2-Ethylhexanoyl chloride is very toxic after inhalation, of moderate toxicity after swallowing and of low toxicyty after dermal contact. - LD50 (oral; rat): 1410 mg/kg-bw. - LD50 (demal; rabbit): >2010 mg/kg. - LC50 (inhal.; rat): 1.26 mg/L/1h. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25aea0c7-1b15-4fec-b24b-5a0b23f2df8e/documents/IUC5-c5b39e42-fbab-4817-a135-37d8362ebf09_1b93161b-4261-45dc-a609-bcadc05f483d.html,,,,,, "2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide",83547-95-9," 28 -day repeated dose toxicity: oral, rat ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7f24a8a3-c933-4acd-b259-c5af0a600034/documents/041fdd91-0aac-4587-b1d5-43456adedf67_bebcf28a-5164-4fd6-aa4f-9119e683b497.html,,,,,, "2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide",83547-95-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7f24a8a3-c933-4acd-b259-c5af0a600034/documents/041fdd91-0aac-4587-b1d5-43456adedf67_bebcf28a-5164-4fd6-aa4f-9119e683b497.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide",83547-95-9, Acute oral LD50 (rat) Acute oral LD50 (hampster) Acute dermal LD50 (rat) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f24a8a3-c933-4acd-b259-c5af0a600034/documents/1c2802cb-c2b6-41f6-ad7c-33bfd02ffd8a_bebcf28a-5164-4fd6-aa4f-9119e683b497.html,,,,,, "2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide",83547-95-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f24a8a3-c933-4acd-b259-c5af0a600034/documents/1c2802cb-c2b6-41f6-ad7c-33bfd02ffd8a_bebcf28a-5164-4fd6-aa4f-9119e683b497.html,,oral,LD50,"3,313 mg/kg bw",adverse effect observed, "2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide",51032-53-2, Acute oral toxicity in rats (OECD 401) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84c552a4-4abc-4d3b-a625-1ea17c884548/documents/7f0d0142-44da-438e-b52e-a2df193dcd52_e89207d5-1579-4c3c-a578-98ab14e1a12c.html,,,,,, "2-ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2-oxoethyl]thio]-7-oxo-8-oxa-3,5-dithia-4-phosphatetradecanoate 4-oxide",51032-53-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84c552a4-4abc-4d3b-a625-1ea17c884548/documents/7f0d0142-44da-438e-b52e-a2df193dcd52_e89207d5-1579-4c3c-a578-98ab14e1a12c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-ethylhexyl 14-ethyl-6,6-dioctyl-4,8,11-trioxo-5,7,12-trioxa-6-stannaoctadeca-2,9-dienoate",10039-33-5," NOAEL (oral)= 5 mg/kg diet (based on the effects noted in the thymus) in the rat, equivalent to 0.3-0.4 mg/kg bw/day for male animals and 0.3-0.5 mg/kg bw/day for female animals. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f810b91-400d-4ba4-b8f7-76210175bffa/documents/6e66a2fd-2572-4d4f-b4da-c2d8fa9876a2_769ab20a-84a5-4778-8605-4efb5d26101d.html,,,,,, "2-ethylhexyl 14-ethyl-6,6-dioctyl-4,8,11-trioxo-5,7,12-trioxa-6-stannaoctadeca-2,9-dienoate",10039-33-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f810b91-400d-4ba4-b8f7-76210175bffa/documents/6e66a2fd-2572-4d4f-b4da-c2d8fa9876a2_769ab20a-84a5-4778-8605-4efb5d26101d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,0.525 mg/kg bw/day,,rat "2-ethylhexyl 14-ethyl-6,6-dioctyl-4,8,11-trioxo-5,7,12-trioxa-6-stannaoctadeca-2,9-dienoate",10039-33-5, LD50 (oral) = 3793 mg/kg (male/female rat) LD50 (dermal) >2000 mg/kg bw (male/female rat) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f810b91-400d-4ba4-b8f7-76210175bffa/documents/0b203518-968e-4f22-baf2-4c30d8fe7256_769ab20a-84a5-4778-8605-4efb5d26101d.html,,,,,, "2-ethylhexyl 14-ethyl-6,6-dioctyl-4,8,11-trioxo-5,7,12-trioxa-6-stannaoctadeca-2,9-dienoate",10039-33-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f810b91-400d-4ba4-b8f7-76210175bffa/documents/0b203518-968e-4f22-baf2-4c30d8fe7256_769ab20a-84a5-4778-8605-4efb5d26101d.html,,oral,LD50,"3,793 mg/kg bw",no adverse effect observed, "2-ethylhexyl 14-ethyl-6,6-dioctyl-4,8,11-trioxo-5,7,12-trioxa-6-stannaoctadeca-2,9-dienoate",10039-33-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f810b91-400d-4ba4-b8f7-76210175bffa/documents/0b203518-968e-4f22-baf2-4c30d8fe7256_769ab20a-84a5-4778-8605-4efb5d26101d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-ethylhexyl 2-([1,1'-biphenyl]-4-ylcarbonyl)benzoate",75005-95-7,Study conducted to recognised testing guidelines with GLP certification. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1870ca42-7b72-447a-ab84-66201a5b9edc/documents/28033d5b-c734-41cb-8bbe-7efeb5d54373_af1f8e6e-1ab7-406a-be8d-e80057453d50.html,,,,,, "2-ethylhexyl 2-([1,1'-biphenyl]-4-ylcarbonyl)benzoate",75005-95-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1870ca42-7b72-447a-ab84-66201a5b9edc/documents/28033d5b-c734-41cb-8bbe-7efeb5d54373_af1f8e6e-1ab7-406a-be8d-e80057453d50.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-ethylhexyl 2-([1,1'-biphenyl]-4-ylcarbonyl)benzoate",75005-95-7," Acute Toxicity Acute toxicity: oral.Key CRL 2020 OECD 423 The oral LD50 value of the test item in Wistar Han rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. Based on these results, the test item does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1870ca42-7b72-447a-ab84-66201a5b9edc/documents/4183e34f-0eb3-4d38-910a-aafdb694ca01_af1f8e6e-1ab7-406a-be8d-e80057453d50.html,,,,,, "2-ethylhexyl 3,5,5-trimethylhexanoate",70969-70-9," A No Observed Adverse Effect Level (NOAEL) of 50 mg/kg body weight/day was established from a repeated dose study, based on adrenals effects in females. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2872648f-6565-4726-ae60-824d2767e1c1/documents/ae4b4b51-74cd-4c00-a9ef-28df300a479d_d55e22e3-5fbf-4771-8032-0e2e35996915.html,,,,,, "2-ethylhexyl 3,5,5-trimethylhexanoate",70969-70-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2872648f-6565-4726-ae60-824d2767e1c1/documents/ae4b4b51-74cd-4c00-a9ef-28df300a479d_d55e22e3-5fbf-4771-8032-0e2e35996915.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "2-ethylhexyl 3,5,5-trimethylhexanoate",70969-70-9," LD50 (oral, rat) = 5000 mg/kg LD50 (dermal): >2000 mg/kg (assumed) LC50 (inhalative): not tested ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2872648f-6565-4726-ae60-824d2767e1c1/documents/15642266-fd4a-49c5-a6f5-c15412e2be8c_d55e22e3-5fbf-4771-8032-0e2e35996915.html,,,,,, "2-ethylhexyl 3,5,5-trimethylhexanoate",70969-70-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2872648f-6565-4726-ae60-824d2767e1c1/documents/15642266-fd4a-49c5-a6f5-c15412e2be8c_d55e22e3-5fbf-4771-8032-0e2e35996915.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-ethylhexyl 3-mercaptopropionate,50448-95-8,"Based on read across from MMP, the acute oral LD50 of EHMP is estimated to be 353 mg/kg bw. Based on read across from MMP, the acute dermal LD50 of EHMP is estimated to be greater than 2000 mg/kg bw. Based on read across from MMP, the predicted 4-h LC50 is 3.83 mg/L. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d02121d-042d-47c1-807e-ad455a2349bd/documents/dad48031-223b-4e0d-901a-40024fd4de7f_aad89d5e-8e0f-4f8a-85e0-9b0db2133b35.html,,,,,, 2-ethylhexyl 3-mercaptopropionate,50448-95-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d02121d-042d-47c1-807e-ad455a2349bd/documents/dad48031-223b-4e0d-901a-40024fd4de7f_aad89d5e-8e0f-4f8a-85e0-9b0db2133b35.html,,oral,LD50,353 mg/kg bw,adverse effect observed, 2-ethylhexyl 3-mercaptopropionate,50448-95-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d02121d-042d-47c1-807e-ad455a2349bd/documents/dad48031-223b-4e0d-901a-40024fd4de7f_aad89d5e-8e0f-4f8a-85e0-9b0db2133b35.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-ethylhexyl 3-mercaptopropionate,50448-95-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d02121d-042d-47c1-807e-ad455a2349bd/documents/dad48031-223b-4e0d-901a-40024fd4de7f_aad89d5e-8e0f-4f8a-85e0-9b0db2133b35.html,,inhalation,LC50,3.83 mg/L,adverse effect observed, "2-ethylhexyl 4,4-dibutyl-10-ethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",10584-98-2," The treatment related histopathological change of decreased cellularity in the thymic cortex was reported for 15/25 females of the high dose group. The observed decreased cell population in the cortex was described as multifocal to diffuse and severity varied from minimal to marked. The histopathological evaluation of the thymus was extended to the lower dose groups and there was no treatment related changes observed in these animals. Based on the Thymus effect, the NOAEL is > 8.5 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e304459a-83b4-43f8-ac60-c670e110a81a/documents/IUC5-c12d5194-6d92-4067-bff7-85cd44074c69_535225f7-3e3f-4da0-813f-ed139b896b23.html,,,,,, "2-ethylhexyl 4,4-dibutyl-10-ethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",10584-98-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e304459a-83b4-43f8-ac60-c670e110a81a/documents/IUC5-c12d5194-6d92-4067-bff7-85cd44074c69_535225f7-3e3f-4da0-813f-ed139b896b23.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,8.5 mg/kg bw/day,,rat "2-ethylhexyl 4,4-dibutyl-10-ethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",10584-98-2,"ORALThe key study, reports the lowest LD50 and therefore gives the worst case scenario, also, the test material composition contains a higher proportion soybean oil than monobutyltintris(2-ethylhexylthioglycolate) compared to the other 3 studies by the same laboratory. 7 further studies were provided in support:Sarasin, G. (1980) Acute Oral LD50 in the Rat of TK 10701. Testing Laboratory: CIBA-GEIGY Limited, Basle, Switzerland. Owner company: Crompton GmbH, Polymerchemilkalien, Postfach 1620, D-59180, Bergkamen. Report No.: 801408. Report date: 1980-10-20. The study was performed to OECD 401, reported to a good standard and assigned a reliability score of 2. The LD50 was reported as 369 mg/kg bw.DERMALThe studies are presented as a weight of evidence.Arcelin. G (2001) Mark 17M: Acute Dermal Toxicity Study in Rats. Testing Laboratory: RCC Ltd, Toxicology Division, Wölferstrasse 4, CH-4414, Füllinsdorf Switzerland. Owner company: Crompton Vinyl Additives GmbH, Chemiestrasse 22, D-68623 Lampertheim, Germany. Report No.: 785687. Report date: 2001-06-21.Sarasin G (1981) Acute Dermal LD50 in the Rat of TK 10'701. Testing Laboratory: CIBA-GEIGY Limited, Basle, Switzerland. Owner company: Plastics and Additives Division, CIBA-GEIGY MARIENBERG GMBH, 6140 Marienberg Post Bensheim. Report No.: 810905. Report date: 1981-09-17Arcelin G (2001) was assigned a reliability score of 1. The study was performed to OECD 402 and to GLP. The second study Sarasin G (1981) was also performed to a method equivalent to OECD 402 and assigned a reliability score of 2.The lowest LD50 was selected, 777 mg/kg bwINHALATIONStevens J (1980) Report on Acute Aerosol Inhalation Toxicity in the Rat of TK-12824 Testing laboratory: CIBA-GEIGY Limited, Basle, Switzerland Owner company: Plastic and Additives Division Report No.: 801474. Report date: 1980-10-30The study was performed to a good standard and assigned a reliability score of 2. The LC50 was 941 (758-1283) mg/m^3. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e304459a-83b4-43f8-ac60-c670e110a81a/documents/IUC5-92182fe2-bc5c-427a-b0b4-ceaf59c33405_535225f7-3e3f-4da0-813f-ed139b896b23.html,,,,,, "2-ethylhexyl 4,4-dibutyl-10-ethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",10584-98-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e304459a-83b4-43f8-ac60-c670e110a81a/documents/IUC5-92182fe2-bc5c-427a-b0b4-ceaf59c33405_535225f7-3e3f-4da0-813f-ed139b896b23.html,,oral,LD50,396 mg/kg bw,, "2-ethylhexyl 4,4-dibutyl-10-ethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",10584-98-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e304459a-83b4-43f8-ac60-c670e110a81a/documents/IUC5-92182fe2-bc5c-427a-b0b4-ceaf59c33405_535225f7-3e3f-4da0-813f-ed139b896b23.html,,dermal,LD50,777 mg/kg bw,, "2-ethylhexyl 4,4-dibutyl-10-ethyl-7-oxo-8-oxa-3,5-dithia-4-stannatetradecanoate",10584-98-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e304459a-83b4-43f8-ac60-c670e110a81a/documents/IUC5-92182fe2-bc5c-427a-b0b4-ceaf59c33405_535225f7-3e3f-4da0-813f-ed139b896b23.html,,inhalation,LC50,941 mg/m3,, 2-ethylhexyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate,62256-00-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e84183b4-702f-4348-b5b2-fa0a6672ee99/documents/6ee542ea-e1b7-467c-a182-b4c262c569ac_220908b2-ac5a-491f-a83c-f1d78b86ad25.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,350 mg/kg bw/day,,rat 2-ethylhexyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate,62256-00-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e84183b4-702f-4348-b5b2-fa0a6672ee99/documents/ec4e69a9-c806-4133-bf84-9a7037879e05_220908b2-ac5a-491f-a83c-f1d78b86ad25.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, 2-ethylhexyl chloroformate,24468-13-1, 2 Ethylhexanoylchloride is of low toxicity via the oral and dermal route of exposure. LD50 values are 5420 mg/kg (oral) and > 3038 mg/kg (dermal). The substance is however very toxic after inhalation. LC50 = 0.27 mg/L/4h.   ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ff0304f-6174-4eac-a7a1-7229eb16f516/documents/IUC5-b673d91b-00df-4df3-b7f4-d43b4eeabb2e_33e7caee-90d5-4be4-ab81-46af2f95edae.html,,,,,, 2-ethylhexyl diphenyl phosphate,1241-94-7,Oral (feeding) 90-d repeated dose toxicity study (equivalent to OECD408): NOAEL 7.3 mg/kg bw/day ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1359fa8-0bb5-4df9-8968-8b0c03cc86c7/documents/IUC5-7a5dfbbe-6519-4b6e-86da-7a86aa829b7e_62073e35-ae23-4f06-bee1-80a8f315baa5.html,,,,,, 2-ethylhexyl diphenyl phosphate,1241-94-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1359fa8-0bb5-4df9-8968-8b0c03cc86c7/documents/IUC5-7a5dfbbe-6519-4b6e-86da-7a86aa829b7e_62073e35-ae23-4f06-bee1-80a8f315baa5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,7.3 mg/kg bw/day,,rat 2-ethylhexyl diphenyl phosphate,1241-94-7,Acute oral toxicity: Standard acute method (no guideline followed): LD50 > 15800 mg/kg (male/female rat).Acute inhalation toxicity: LC50> 4.8 mg/L. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1359fa8-0bb5-4df9-8968-8b0c03cc86c7/documents/IUC5-ef37815f-aaa7-4153-83fd-a33d55bad350_62073e35-ae23-4f06-bee1-80a8f315baa5.html,,,,,, 2-ethylhexyl diphenyl phosphate,1241-94-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1359fa8-0bb5-4df9-8968-8b0c03cc86c7/documents/IUC5-ef37815f-aaa7-4153-83fd-a33d55bad350_62073e35-ae23-4f06-bee1-80a8f315baa5.html,,oral,LD50,"15,800 mg/kg bw",no adverse effect observed, 2-ethylhexyl diphenyl phosphate,1241-94-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1359fa8-0bb5-4df9-8968-8b0c03cc86c7/documents/IUC5-ef37815f-aaa7-4153-83fd-a33d55bad350_62073e35-ae23-4f06-bee1-80a8f315baa5.html,,inhalation,LC50,> 4.8 mg/L,no adverse effect observed, 2-ethylhexyl hydrogen maleate,7423-42-9," Acute toxicity, oral route: LD50 = 1411 mg/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5d91b9b-3181-4e3a-9703-fed4c8a6c0a5/documents/6190c921-150d-42b7-b9ee-afc2c4aabb54_864692b9-68fb-4030-9801-3f9852613378.html,,,,,, 2-ethylhexyl hydrogen maleate,7423-42-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5d91b9b-3181-4e3a-9703-fed4c8a6c0a5/documents/6190c921-150d-42b7-b9ee-afc2c4aabb54_864692b9-68fb-4030-9801-3f9852613378.html,,oral,LD50,"1,411 mg/kg bw",adverse effect observed, 2-ethylhexyl lactate,6283-86-9,Inhalation is the only relevant exposure pathway for 2-ethylhexyl lactate under REACH. ,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3b75baf-d65d-437e-a4dd-6dae7864417f/documents/IUC5-25583a05-655a-4122-9d03-898787675cd8_6eddd4df-1afb-40c1-8a8a-677dbd625096.html,,,,,, 2-ethylhexyl lactate,6283-86-9,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3b75baf-d65d-437e-a4dd-6dae7864417f/documents/IUC5-25583a05-655a-4122-9d03-898787675cd8_6eddd4df-1afb-40c1-8a8a-677dbd625096.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,600 mg/m3,,rat 2-ethylhexyl lactate,6283-86-9,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3b75baf-d65d-437e-a4dd-6dae7864417f/documents/IUC5-25583a05-655a-4122-9d03-898787675cd8_6eddd4df-1afb-40c1-8a8a-677dbd625096.html,Repeated dose toxicity – local effects,inhalation,LOAEC,75 mg/m3,adverse effect observed,rat 2-ethylhexyl lactate,6283-86-9,2-Ethylhexyl lactate is practically non-toxic by the oral and inhalation route. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3b75baf-d65d-437e-a4dd-6dae7864417f/documents/IUC5-80d57b41-efba-42bb-b5a0-2e261bed5a5f_6eddd4df-1afb-40c1-8a8a-677dbd625096.html,,,,,, 2-ethylhexyl lactate,6283-86-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3b75baf-d65d-437e-a4dd-6dae7864417f/documents/IUC5-80d57b41-efba-42bb-b5a0-2e261bed5a5f_6eddd4df-1afb-40c1-8a8a-677dbd625096.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-ethylhexyl lactate,6283-86-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3b75baf-d65d-437e-a4dd-6dae7864417f/documents/IUC5-80d57b41-efba-42bb-b5a0-2e261bed5a5f_6eddd4df-1afb-40c1-8a8a-677dbd625096.html,,inhalation,LC50,"5,600 mg/m3",adverse effect observed, 2-ethylhexyl mercaptoacetate,7659-86-1," The administration of up to 0.2% EHTG in the diet of rats for 28 days did not lead to a proliferation of hepatic peroxisomes, and did not produce any treatment-related effects. The 28 day NOAEL was 0.2% EHTG in the diet (the highest dose tested; 168 mg/kg bw for males; 173 mg/kg bw for females).   Oral Groups of male and female rats were exposed to EHTG in a feeding study at concentrations of 0, 0.05, 0.1 and 0.2% for a period of 28 days (BIBRA, 1988). One group of 5 males and 5 females was treated with di-(2-etlhexyl)phthalate (DEHP) as positive control for peroxisome proliferation. Clinical observations were performed daily and weekly detailed examinations were made. Body weights and food intake was measured on days 0 and 3, and then twice weekly. Macroscopic exam, organ weights, haematology and blood chemistry were performed at the end of the treatment period. Microscopic examination of selected organs was performed for control and high EHTG dose groups. Electronic microscopy was used for examination of the liver from control and high EHTG dose groups. The actual dose received by sex was as follows:   DIETARY LEVEL MALES FEMALES % (mg/kg/day) (mg/kg/day) 0.05 42 45 0.1 82 87 0.2 168 173   There were no statistically significant differences between the bodyweights of the control and EHTG treated groups. There were no statistically significant differences between the food intakes of male control rats and male rats treated with the three dose levels of EHTG or 1.2 % DEHP. Female rats treated with EHTG consistently consumed more diet than the control group throughout the study. These differences were statistically significant for female rats treated with 0.05 % EHTG on study days 20-24 and 24-27 respectively, and for animals given 0.1 % EHTG on study days 20-24. The food intakes of female rats treated with 1.2 % DEHP did not differ statistically from the control group. No abnormalities of condition or behavior were seen in female rats given EHTG. The white blood cell and lymphocyte counts for EHTG treated male rats were lower than the controls, and these differences were statistically significant for the 0.1 % and 0.2 % EHTG dose groups. The mean cell haemoglobin for male rats treated with 0.2 % EHTG was statistically significantly lower than the controls. Female rats treated with 0.2% EHTG had statistically higher haematocrit values, mean cell volumes and platelet counts than the control animals. There were no statistically significant differences between control and EHTG treated female rats, in the three dose groups, for any of the serum chemical measurements. For male rats the only statistically significant difference between control and EHTG treated animals was an increase in aspartate aminotransferase activity in the 0.2 % EHTG group. There were no deaths. A few animals from all groups showed minor changes in the appearance of their liver, kidneys or lungs. The pattern of incidence was unrelated to treatment.Male rats administered 0.05 % and 0.2% EHTG had statistically significantly higher relativekidney weights than the controls, but no effect on absolute kidney weights. Female rats treated with EHTG had significantly higher absolute (at 0.1 % and 0.05 % of EHTG) and relative kidney weights (at 0.1% EHTG) than the control animals. Hepatic protein concentrations were slightly higher than controls in male and female rats treated with the two top doses of EHTG (0.1 % and 0.2 %), though the differences were not statistically significant. Treatment with EHTG did not produce any statistically significant increases in cyanide-insensitive palmitoyl-CoA oxidation or lauric acid 11- and 12-hydroxylation in male or female rats. There were no significant changes in microsomal protein concentrations of EHTG treated male and female rats compared with the control group. EHTG in the diet of rats for 28 days does not lead to a proliferation of hepatic peroxisomes, and does not produce any treatment-related effects. The NOAEL was 0.2 % EHTG in the diet (168 mg/kg bw for males; 173 mg/kg bw for females).   In a range-finding study, 2-ethylhexyl mercaptoacetate, in the vehicle, corn oil, was administered orally by gavage to three groups of five Crl:CD(SD) rats/sex/dose once daily for 14 days (Bowman, 2005). Dosage levels were 10, 50 and 150 mg/kg/day administered at a dosage volume of 4 mL/kg. A concurrent control group composed of five animals/sex received the vehicle on a comparable regimen. All animals were observed twice daily for mortality and moribundity. Clinical observations, body weights and food consumption were recorded daily. On study day 14, each surviving animal was subjected to a gross necropsy and selected organs were weighed. One female in the 150 mg/kg/day group was found dead on study day 2. Decreased defecation was observed in three females in the 150 mg/kg/day group. Body weight losses and associated slight decrease in feed consumption were observed in the 150 mg/kg/day group males and females during the first week of dose administration. Nevertheless, when the overall treatment period (study days 0-14) was evaluated, mean male and female body weight gains in the 150 mg/kg/day groups were found to be only slightly lower (not statistically significant) than the respective control groups. Increased absolute and relative (to final body weight) liver weights were observed in the 50 mg/kg/day (males) and the 150 mg/kg/day (males and females) groups. Absolute and relative kidney weights were increased in the 50 and 150 mg/kg/day males compared to control group values. Absolute and relative thymus gland and thyroid/parathyroid gland weights in the 150 mg/kg/day males and females were slightly reduced compared to the control animals. Based on the results of this study, dosage levels of 10, 50 and 150 mg/kg/day were selected for a reproduction/developmental toxicity screening study of 2-ethlyhexyl mercaptoacetate administered orally by gavage to rats. The NOAEL of this 14-day study in rats should be derived at 50 mg/kg bw/d, based on the death of a female at 150 mg/kg bw/d and associated clinical findings observed at this level. As increases in kidney and liver weight observed in animals dosed at 50 mg/kg bw/d were not found to be statistically significant and because of the absence of gross pathology findings at this dose, these effects should be considered as not toxicologically relevant.   In a range-finding study, groups of 5 rats/sex (Sprague-Dawley) were given 99.5% pure EHTG at doses of 0, 150, 200 or 250 mg/kg bw as a solution in corn oil by gavage on 7 consecutive days (Worell, 1992). After 2 to 4 days, 6 rats in the high dose group and 4 in the medium dose group died or had to be killed in a moribund condition. The rats in the low dose group survived but showed occasional signs of toxicity such as unclean coats and staining in the urogenital area, effects which were also observed in the survivors in the higher dose groups. Post-mortems revealed no effects that could be unequivocally attributed to the treatment. Histological examination primarily revealed micro-vacuolisation in the liver, which could have been due to deposition of fat as a consequence of anorexia. Within the limits of the experimental design, the no effect level was 150 mg/kg bw. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c71d08c-470b-41c0-8769-96b70809ab14/documents/IUC5-8952beea-cd6d-4f6b-a30f-7496d858eeb0_78deed4d-e55a-4a30-a559-10523787e31e.html,,,,,, 2-ethylhexyl mercaptoacetate,7659-86-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c71d08c-470b-41c0-8769-96b70809ab14/documents/IUC5-8952beea-cd6d-4f6b-a30f-7496d858eeb0_78deed4d-e55a-4a30-a559-10523787e31e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,170 mg/kg bw/day,,rat 2-ethylhexyl mercaptoacetate,7659-86-1," Acute toxicity studies have been conducted with EHTG by the dermal, inhalation and oral routes of exposure.  The acute oral toxicity value indicate moderate toxicity, with LD50 value in rats of 303 – 334 mg/kg bw. Acute dermal and inhalation toxicity is low, with an inhalation LC0 value in rats higher than 0.51 mg/L and dermal LD50 value in rats greater than 2000 mg/kg bw.   Oral In an acute oral rat toxicity study with EHTG in peanut oil, the LD50 was 303 mg/kg bw (males) and 334 mg/kg bw (females) (Schmidt et al, 1974). There were 70 animals assigned to this study. There were no adverse effects seen in any of the rats during the macroscopic examination at necropsy and body weights were not adversely affected. A single sublethal doses of 80 mg EHTG/kg bw produced no significant damage of the liver or kidneys in either sex. In an acute oral mouse toxicity study conducted under the same regimen as for rats (Schmidt et al, 1974), the LD50 for EHTG was 1430 (females) to 1710 (males) mg/kg bw. There were 70 animals assigned to this study. In an acute oral rabbit toxicity study conducted under the same regimen as for rats (Schmidt et al, 1974), the LD50 for EHTG was 534 mg/kg bw (males). There were 8 animals assigned to this study. In an acute oral guinea pig toxicity study conducted under the same regimen as for rats (Schmidt et al, 1974), the LD50 for EHTG was 955 (males) -1120 mg/kg bw (females). There were 66 animals assigned to this study.   Inhalation In a 6 hr-inhalation study with EHTG, no mortality was observed in a rats, mice or guinea pigs exposed to 0.51 mg/L. At the end of the observation period, the body weights were normal and the necropsy did not reveal any substance related adverse effects (Schmidt et al, 1974). Dermal Undiluted EHTG was applied to the skin of ten Sprague-Dawley male and female rats at a dose of 2000 mg/kg (Clouzeau, 1993) following OECD test guideline 402. The test site was then covered by a semi-occlusive dressing for 24 hours. Clinical signs, mortality and body weight gain were checked for a period of 14 days and all animals were subjected to necropsy. Death occurred in 20% of the animals. No skin reactions were observed. On day 2 following exposure a marked decrease in spontaneous activity was noted in 4 animals. On day 5, there was a decrease in the body weight in a few animals. Thereafter, clinical signs and body weight gain were not affected by treatment. A macroscopic examination revealed no abnormalities. The LD50 for EHTG was greater than 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c71d08c-470b-41c0-8769-96b70809ab14/documents/IUC5-1c5b653f-9fb1-46bd-aef3-a5c2f7a6c061_78deed4d-e55a-4a30-a559-10523787e31e.html,,,,,, 2-ethylhexyl mercaptoacetate,7659-86-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c71d08c-470b-41c0-8769-96b70809ab14/documents/IUC5-1c5b653f-9fb1-46bd-aef3-a5c2f7a6c061_78deed4d-e55a-4a30-a559-10523787e31e.html,,oral,LD50,303 mg/kg bw,adverse effect observed, 2-ethylhexyl mercaptoacetate,7659-86-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c71d08c-470b-41c0-8769-96b70809ab14/documents/IUC5-1c5b653f-9fb1-46bd-aef3-a5c2f7a6c061_78deed4d-e55a-4a30-a559-10523787e31e.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-ethylhexyl mercaptoacetate,7659-86-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c71d08c-470b-41c0-8769-96b70809ab14/documents/IUC5-1c5b653f-9fb1-46bd-aef3-a5c2f7a6c061_78deed4d-e55a-4a30-a559-10523787e31e.html,,inhalation,discriminating conc.,510 mg/m3,no adverse effect observed, 2-ethylhexyl nitrate,27247-96-7," No repeat dose toxicity studies conducted via the oral route are currently available for 2 -EHN. However, it is worth nothing that in an OECD 421 Reproduction / Developmental Toxicity Screening Test, 2 -EHN was administered daily by oral gavage to male and female Sprague-Dawley rats at doses of 20, 100 or 500 mg/kg/day and the NOAEL for parental toxicity was considered to be 20 mg/kg/day (see the section on Toxicity to reproduction for further details). In the key study for inhalation exposure using the read-across substance 2 -ethylhexan-1ol, no substance related adverse effects of the test item were observed at the highest vapour concentration achievable. A NOAEL of 863 mg/m3 air was derived for 2 -EHN, based on equimolar conversions and 2 -EHN is considered to be non-toxic at saturated vapour concentrations. However, this strategy of reading across from 2 -ethylhexan-1 -ol has been rejected (Decision TPE-D-0000002102 -92 -05/F). A sub-chronic repeated dose toxicity study (90 -day with 28 -day recovery period; according to OECD Test Guideline 413) with exposure to 2 -EHN via the inhalation route in rats is currently in progress, according to Decision TPE-D-0000002102 -92 -05/F. The dossier will be updated with the study results once these become available. In the 14-day dose range finding study that was completed prior to the 90-day study, a NOAEC of 1.071 mg/l air was identified. In a 3 -week study, 2 -EHN was applied dermally under semi-occlusion to rabbit skin for 5 days/week. The systemic NOAEL was 500 mg/kg/day based on the lack of systemic effects at any dose. A NOAEC of 0.22 mg/cm2 was derived for local effects based on skin cracking, erythema and edema (derivation detailed under the Irritation section). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93bc3a0c-93cf-4a05-ba0a-cdacca3d4d47/documents/17a33f56-1bba-4006-9201-18b7edded4b1_5476c577-ffc8-45a9-bdba-0b22d163d1b3.html,,,,,, 2-ethylhexyl nitrate,27247-96-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93bc3a0c-93cf-4a05-ba0a-cdacca3d4d47/documents/17a33f56-1bba-4006-9201-18b7edded4b1_5476c577-ffc8-45a9-bdba-0b22d163d1b3.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rabbit 2-ethylhexyl nitrate,27247-96-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93bc3a0c-93cf-4a05-ba0a-cdacca3d4d47/documents/17a33f56-1bba-4006-9201-18b7edded4b1_5476c577-ffc8-45a9-bdba-0b22d163d1b3.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,863 mg/m3,,rat 2-ethylhexyl nitrate,27247-96-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93bc3a0c-93cf-4a05-ba0a-cdacca3d4d47/documents/17a33f56-1bba-4006-9201-18b7edded4b1_5476c577-ffc8-45a9-bdba-0b22d163d1b3.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.22 mg/cm2,adverse effect observed,rabbit 2-ethylhexyl nitrate,27247-96-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93bc3a0c-93cf-4a05-ba0a-cdacca3d4d47/documents/17a33f56-1bba-4006-9201-18b7edded4b1_5476c577-ffc8-45a9-bdba-0b22d163d1b3.html,Repeated dose toxicity – local effects,inhalation,NOAEC,863 mg/m3,no adverse effect observed,rat 2-ethylhexyl nitrate,27247-96-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Only one study is available which has been given a reliability rating of 2, despite a number of limitations. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Only one study is available which has been given a reliability rating of 1, as it was conducted according to OECD Test Guidelines and GLP, with only one minor deviation. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Only one study is available which has been given a reliability rating of 2, despite a number of limitations. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93bc3a0c-93cf-4a05-ba0a-cdacca3d4d47/documents/a3a6e816-d331-4855-bea6-9a81ddba9862_5476c577-ffc8-45a9-bdba-0b22d163d1b3.html,,,,,, 2-ethylhexyl nitrate,27247-96-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93bc3a0c-93cf-4a05-ba0a-cdacca3d4d47/documents/a3a6e816-d331-4855-bea6-9a81ddba9862_5476c577-ffc8-45a9-bdba-0b22d163d1b3.html,,oral,LD50,"> 9,600 mg/kg bw",no adverse effect observed, 2-ethylhexyl nitrate,27247-96-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93bc3a0c-93cf-4a05-ba0a-cdacca3d4d47/documents/a3a6e816-d331-4855-bea6-9a81ddba9862_5476c577-ffc8-45a9-bdba-0b22d163d1b3.html,,dermal,LD0,"> 4,800 mg/kg bw",no adverse effect observed, 2-ethylhexyl nitrate,27247-96-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93bc3a0c-93cf-4a05-ba0a-cdacca3d4d47/documents/a3a6e816-d331-4855-bea6-9a81ddba9862_5476c577-ffc8-45a9-bdba-0b22d163d1b3.html,,inhalation,LC50,> 5.65 mg/L,adverse effect observed, 2-ethylhexylamine,104-75-6," Inhalation exposure of 5, 25 and 125 mg/m³ 2-Ethylhexylamine for 90 days (65 exposures) caused treatment-related adverse histological changes in the nasal cavity levels I and II. Moreover, slight but significantly lower body weight and body weight gain was observed in male animals of the high concentration group (125 mg/m³). No systemic effects were observed. The No Observed Adverse Effect Concentration (NOAEC) was 25 mg/m³ for local effects under the current study conditions. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35ba76c2-089a-45f3-a3bb-deb2e48a6d4b/documents/cec3cfec-2cfe-4c51-8293-abe5860c5fec_4c4a3006-c271-4fdd-b18d-c98e40158bc3.html,,,,,, 2-ethylhexylamine,104-75-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35ba76c2-089a-45f3-a3bb-deb2e48a6d4b/documents/cec3cfec-2cfe-4c51-8293-abe5860c5fec_4c4a3006-c271-4fdd-b18d-c98e40158bc3.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,125 mg/m3,,rat 2-ethylhexylamine,104-75-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35ba76c2-089a-45f3-a3bb-deb2e48a6d4b/documents/cec3cfec-2cfe-4c51-8293-abe5860c5fec_4c4a3006-c271-4fdd-b18d-c98e40158bc3.html,Repeated dose toxicity – local effects,inhalation,NOAEC,25 mg/m3,adverse effect observed,rat 2-ethylhexylamine,104-75-6, Acute Toxicity: - oral: LD50 = 316 mg/kg bw (male/female rat) equivalent to OECD 401; - inhalation: LC50 < 1.548 mg/L air (male/female rat) according to OECD 403; - dermal: study using 'rabbit' as test species - disregarded ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35ba76c2-089a-45f3-a3bb-deb2e48a6d4b/documents/94d23519-2c71-411c-8552-6a3cdf66d75c_4c4a3006-c271-4fdd-b18d-c98e40158bc3.html,,,,,, 2-ethylhexylamine,104-75-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35ba76c2-089a-45f3-a3bb-deb2e48a6d4b/documents/94d23519-2c71-411c-8552-6a3cdf66d75c_4c4a3006-c271-4fdd-b18d-c98e40158bc3.html,,oral,LD50,316 mg/kg bw,adverse effect observed, 2-ethylhexylamine,104-75-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35ba76c2-089a-45f3-a3bb-deb2e48a6d4b/documents/94d23519-2c71-411c-8552-6a3cdf66d75c_4c4a3006-c271-4fdd-b18d-c98e40158bc3.html,,inhalation,discriminating conc.,"1,548 mg/m3",adverse effect observed, 2-ethylimidazole,1072-62-4,"Oral LD50 = 1400 mg/kg bw, mortality was observed (BASF, 1967)Dermal LD50 > 200 mg/kg bw, no mortality observed (BASF, 1980)Inhalation LC50 > 0.015 mg/L air (BASF, 1967), LC50 >0.03 mg/L air (BASF, 1980) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a02bb2f0-04e8-4dfe-ac9e-723ee19c70dc/documents/IUC5-f44b509f-ba01-4215-9586-e16c35ca2990_22af1657-fb8f-417a-8d35-1a9e36a0e31e.html,,,,,, 2-ethylimidazole,1072-62-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a02bb2f0-04e8-4dfe-ac9e-723ee19c70dc/documents/IUC5-f44b509f-ba01-4215-9586-e16c35ca2990_22af1657-fb8f-417a-8d35-1a9e36a0e31e.html,,oral,LD50,"1,400 mg/kg bw",adverse effect observed, 2-ethyl-N-(3-methoxyphenyl)-N-methylbutanamide,2101947-22-0," In summary, oral administration of FRET 15 -0735 via the diet produced hepatocyte hypertrophy (in all rats) and an increase in liver weight (35 to 37% higher than control) at a dose level of 5000, and did not produce any severe toxicity or adverse effect up to the dose level of 2000 ppm in diet after the 28 day dietary administration in Wistar rats. The NOAEL (No Observed Adverse Effect Level) for FRET 15-0735 of both male and female rats was found to be 2000 ppm in diet (corresponding to 199.67 ± 35.87 mg/kg b. wt./day for male and corresponding to 208.33 ± 27.80 mg/kg b. wt./day for female) under the conditions and procedures followed in this study. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcf06d0c-5fed-4aca-a609-bfd4a5faaa25/documents/0674b755-e162-4543-b0a2-3ef0a30509ab_3c5a396f-707e-4587-a0c3-82f5c45d639d.html,,,,,, 2-ethyl-N-(3-methoxyphenyl)-N-methylbutanamide,2101947-22-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcf06d0c-5fed-4aca-a609-bfd4a5faaa25/documents/0674b755-e162-4543-b0a2-3ef0a30509ab_3c5a396f-707e-4587-a0c3-82f5c45d639d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,199.67 mg/kg bw/day,,rat 2-ethyl-N-(3-methoxyphenyl)-N-methylbutanamide,2101947-22-0, Acute oral toxicity: OECD TG 420: LD50 50-300 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcf06d0c-5fed-4aca-a609-bfd4a5faaa25/documents/315ef4c1-fa26-4cce-b85f-7330d5efa9b7_3c5a396f-707e-4587-a0c3-82f5c45d639d.html,,,,,, "2-ethyl-N,N-bis(2-ethylhexyl)hexylamine",1860-26-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9209e84-fd7f-468c-970e-897d53a29a92/documents/IUC5-ddf644fe-ed7f-4cd9-800c-2c91b511e296_a2f84df5-5cc8-4c2e-868e-123ce7d31396.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,21 mg/kg bw/day,,rat "2-ethyl-N,N-bis(2-ethylhexyl)hexylamine",1860-26-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9209e84-fd7f-468c-970e-897d53a29a92/documents/IUC5-b2a1cb8c-5f32-44d6-b358-496bec51a5d5_a2f84df5-5cc8-4c2e-868e-123ce7d31396.html,,oral,discriminating dose,"8,170 mg/kg bw",no adverse effect observed, "2-ethyl-N,N-bis(2-ethylhexyl)hexylamine",1860-26-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9209e84-fd7f-468c-970e-897d53a29a92/documents/IUC5-b2a1cb8c-5f32-44d6-b358-496bec51a5d5_a2f84df5-5cc8-4c2e-868e-123ce7d31396.html,,inhalation,discriminating conc.,230 mg/m3,no adverse effect observed, 2-fluoro-6-trifluoromethylpyridine,94239-04-0,"Oral: OECD 408; 90-day feeding, rats. NOEL = 2500 mg/kg diet (corresponds to 218.8 and 246.9 mg/kg bw/day for males and females, respectively), based on liver and kidney weight and changes in blood biochemistry indicating an effect in liver function at 12500 mg/kg. Reliability = K2Inhalation: OECD 412; 28-day, rats. NOEL = 15.2 ppm, based on liver and kidney weight and histopathological effects at 159 ppm. Reliability = K1 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9758543a-bf51-480a-ad61-eb5acc110c9a/documents/754a97c7-08d9-4509-b48b-7328e2972210_0231982a-5f4a-4ad5-bccf-6c5083502333.html,,,,,, 2-fluoro-6-trifluoromethylpyridine,94239-04-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9758543a-bf51-480a-ad61-eb5acc110c9a/documents/754a97c7-08d9-4509-b48b-7328e2972210_0231982a-5f4a-4ad5-bccf-6c5083502333.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,218.8 mg/kg bw/day,,rat 2-fluoro-6-trifluoromethylpyridine,94239-04-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9758543a-bf51-480a-ad61-eb5acc110c9a/documents/754a97c7-08d9-4509-b48b-7328e2972210_0231982a-5f4a-4ad5-bccf-6c5083502333.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,102.6 mg/m3,,rat 2-fluoro-6-trifluoromethylpyridine,94239-04-0,"Oral: OECD 425. discriminating dose, rat. The overall discriminating dose level was 50 mg/kg. Reliability = 1 Dermal: OECD 402. LD50, rat. The LD50 was >2500 mg/kg. Reliability = 1Inhalation: OECD 403. 4-hr LC50, rat. The LC50 was 1984 ppm (13396 mg/m3) in females and 3075 ppm (20762 mg/m3) in males. Reliability =1. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9758543a-bf51-480a-ad61-eb5acc110c9a/documents/f2b08cad-8101-4936-9689-74fe7e397332_0231982a-5f4a-4ad5-bccf-6c5083502333.html,,,,,, 2-fluoro-6-trifluoromethylpyridine,94239-04-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9758543a-bf51-480a-ad61-eb5acc110c9a/documents/f2b08cad-8101-4936-9689-74fe7e397332_0231982a-5f4a-4ad5-bccf-6c5083502333.html,,oral,discriminating dose,50 mg/kg bw,, 2-fluoro-6-trifluoromethylpyridine,94239-04-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9758543a-bf51-480a-ad61-eb5acc110c9a/documents/f2b08cad-8101-4936-9689-74fe7e397332_0231982a-5f4a-4ad5-bccf-6c5083502333.html,,dermal,LD50,"2,500 mg/kg bw",, 2-fluoro-6-trifluoromethylpyridine,94239-04-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9758543a-bf51-480a-ad61-eb5acc110c9a/documents/f2b08cad-8101-4936-9689-74fe7e397332_0231982a-5f4a-4ad5-bccf-6c5083502333.html,,inhalation,LC50,"13,396 mg/m3",, 2-fluoroaniline,348-54-9,"No study data exist for 2-Fluoroaniline. However, based on information of the structural analogue Aniline CAS 62-53-3 a hazard after repeated exposure on particular the blood system (Met-Hb induction) can be anticipated for 2-Fluoroaniline. Aniline is classified Cat. 1 for STOT-RE. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6bb3ad78-0d5f-4dd7-87eb-1f906142249b/documents/fee11a3b-07b4-48c5-ba17-f83576d5a01d_ce95f9b2-f789-44d2-9ffa-8832c62efc60.html,,,,,, 2-fluoroaniline,348-54-9,"No study data exist for 2-Fluoroaniline. However, based on information of the structural analogue Aniline CAS 62-53-3 an acute toxicity hazard can be anticipated for 2-Fluoroaniline. Aniline is classified Cat. 3 for all three exposure routes; acute oral, acute dermal and acute inhalation toxicity.   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6bb3ad78-0d5f-4dd7-87eb-1f906142249b/documents/8b0ecd4f-f441-4e8e-bbbb-f381b925816e_ce95f9b2-f789-44d2-9ffa-8832c62efc60.html,,,,,, "2H-1,3-benzoxazine-2,4(3H)-dione",2037-95-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd7f0bab-ff64-4c6a-8f2a-89dc05f40d03/documents/e56fbd5f-7407-4ab5-b1b0-4fc47b4477b2_4099acb0-37d9-4567-819f-0bbbed142c88.html,,oral,LD50,750 mg/kg bw,adverse effect observed, "2H-1-Benzopyran-2-methanol, a,a'-[iminobis(methylene)]bis[6-fluoro-3,4-dihydro-, (aR,a'R,2R,2'S)-rel-",118457-14-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/220ae002-33f8-4f0b-affa-895d63d0e0df/documents/fb9df921-ecf7-4c37-8dc9-f55de86408c7_65fccffa-d4a7-4a36-912e-5d467440fa04.html,,oral,LD50,483 mg/kg bw,, "2H-1-Benzopyran-5-methanol, 2-cyclopropyl-7,8-dimethoxy-",845276-38-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): experimental study ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0958c321-19a6-4921-8bf3-1b6679097b0e/documents/2459f285-8d03-45c7-b086-41d7fc049ea1_52a6b3f4-5606-4c9a-a727-8c8929b175e1.html,,,,,, "Hexamethylene diisocyanate, oligomerisation product, blocked with hexahydro-2H-azepin-2-one",26776-30-7," No repeated-dose toxicity tests are available for the oral or dermal route of exposure. Data waiver are claimed. Furthermore, no subchronic inhalation toxicity study was performed with the registered substance. However, a grouping of substances and read-across approach according to Regulation (EC) No 1907/2006 (REACH), Annex XI 1.5 and following Scenario 4 of the ECHA Read-Across Assessment Framework, RAAF (2015) is accomplished for five blocked diisocyanate oligomers (also for the read-across target substance hexamethylene diisocyanate, oligomeristion product, blocked with caprolactam). For repeated inhalation toxicity testing, the category is divided into two sub-groups – the liquid aerosol for blocked HDI-based oligomers and the powder aerosol for blocked IPDI-based oligomers. Thus, within the category the analogue approach is followed, i.e. ECHA RAAF Scenario 2. Within this analogue approach, a GLP-conform and Guideline-compliant 90-day subchronic inhalation toxicity study was performed with the read-across source (hexamethylene diisocyanate, oligomeristion product, blocked with 3,5 -dimethylpyrazole) for the registered substance on request of ECHA. In this subchronic inhalation toxicity study with 13 week exposure and 13 week recovery period, adverse findings were seen in histopathology of the respiratory tract at 0.3 mg/m³ and above. These effects represent portal-of-entry toxicity. A No-Observed-Adverse-Effect-Concentration (NOAEC) could not be established. Test substance related systemic toxicity was not observed and thus, the NOAEC for systemic toxicity is 7.4 mg/m³, the highest dose tested. An updated outline of a grouping-strategy based on read-across of the available toxicological data for 5 blocked diisocyanate oligomers is attached to the endpoint summaries for 'Repeated dose toxicity' and 'Toxicity to reproduction' in IUCLID as a separate document. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c4dab0c-ae88-40a0-a409-a3168642bb12/documents/IUC5-74df5010-7661-42dd-a7b0-0474ed83d1cc_35200808-f05d-430e-aade-ae3a1cecb3af.html,,,,,, "Hexamethylene diisocyanate, oligomerisation product, blocked with hexahydro-2H-azepin-2-one",26776-30-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c4dab0c-ae88-40a0-a409-a3168642bb12/documents/IUC5-74df5010-7661-42dd-a7b0-0474ed83d1cc_35200808-f05d-430e-aade-ae3a1cecb3af.html,Repeated dose toxicity – local effects,inhalation,LOAEC,0.3 mg/m3,adverse effect observed,rat "Hexamethylene diisocyanate, oligomerisation product, blocked with hexahydro-2H-azepin-2-one",26776-30-7,"The test item is of low oral and inhalative acute toxicity with an oral LD50 (rat) of > 1800 mg/kg bw (NOTOX, 2002 and Bayer; 2008) and an inhalative LC50 (rat, aerosol, 4 hrs) of > 3069 mg/m3 (BHC, 2012). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c4dab0c-ae88-40a0-a409-a3168642bb12/documents/IUC5-6531dded-9812-4e75-bc8b-f01f565241ad_35200808-f05d-430e-aade-ae3a1cecb3af.html,,,,,, "Hexamethylene diisocyanate, oligomerisation product, blocked with hexahydro-2H-azepin-2-one",26776-30-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c4dab0c-ae88-40a0-a409-a3168642bb12/documents/IUC5-6531dded-9812-4e75-bc8b-f01f565241ad_35200808-f05d-430e-aade-ae3a1cecb3af.html,,oral,discriminating dose,"1,800 mg/kg bw",no adverse effect observed, "Hexamethylene diisocyanate, oligomerisation product, blocked with hexahydro-2H-azepin-2-one",26776-30-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c4dab0c-ae88-40a0-a409-a3168642bb12/documents/IUC5-6531dded-9812-4e75-bc8b-f01f565241ad_35200808-f05d-430e-aade-ae3a1cecb3af.html,,inhalation,LC50,"3,069 mg/m3",no adverse effect observed, "3,6-dimethylheptan-2-ol",1247790-47-1,"The weight of evidence approach is done with nine studies on acute oral toxicity corresponding to three different molecules tested. As the target substance of this dossier, two of the substances tested are also secondary alcohols with a branched alkyl chain, including an isopropyl group at the end of the alkyl chain: 2,6-Dimethyl-4-heptanol (CAS 108-82-7) and 4-Methyl-2-pentanol (CAS 108-82-7). The third molecule is a secondary alcohol but with a linear alkyl chain: 2-Heptanol (CAS 543-49-7). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad19a6bc-0a85-41f4-8575-374cc11938c1/documents/IUC5-308fa59b-1870-4abe-ab97-1c95d8f88d37_ac26384f-396d-469d-8df1-17f70a05e80e.html,,,,,, "3,6-dimethylheptan-2-ol",1247790-47-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad19a6bc-0a85-41f4-8575-374cc11938c1/documents/IUC5-308fa59b-1870-4abe-ab97-1c95d8f88d37_ac26384f-396d-469d-8df1-17f70a05e80e.html,,oral,LD50,"3,560 mg/kg bw",no adverse effect observed, "Reaction mass of Benzene sulfonic acid, hexadecyl(sulfophenoxy)-,disodium salt and Benzene sulfonic acid, - oxibis[hexadecyl]-, disodium salt",65143-89-7," Sprague-Dawley rats were administered diets containing DOWFAX 8390 at dose levels of 0,50, 100, 200 or 600 mg/kg/day for 90 days. Determinations of body weight and food consumption were made throughout the study. Hematological and clinical chemistry parameters were monitored. Gross and microscopic pathological examinations were conducted at necropsy. The weights of the brain, heart, liver, kidney and testes were recorded. Kidney effects were associated with ingestion of the test material at the two higher doses of 200 and 600 mg/kg/day. The weights of the kidneys were significantly increased at the two higher dose levels among the female rats and at the highest dose level among the male rats. The kidneys of these groups of rats appeared swollen at the time of necropsy and among the females, a slight dilation in the renal tubules was observed microscopically at the highest dose level. The kidney morphology and function was not different from that of control rats at the two lower dose levels of the test material. The study NOEAL for systemic effects is 100 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/379cd30d-7327-4221-a37d-ecbed3fbddfd/documents/IUC5-6d597d93-b7f9-43f8-a456-b6cbce3010e4_8a9d375d-dc76-4e0c-a23f-5c41c41cf52f.html,,,,,, "Reaction mass of Benzene sulfonic acid, hexadecyl(sulfophenoxy)-,disodium salt and Benzene sulfonic acid, - oxibis[hexadecyl]-, disodium salt",65143-89-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/379cd30d-7327-4221-a37d-ecbed3fbddfd/documents/IUC5-6d597d93-b7f9-43f8-a456-b6cbce3010e4_8a9d375d-dc76-4e0c-a23f-5c41c41cf52f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Reaction mass of Benzene sulfonic acid, hexadecyl(sulfophenoxy)-,disodium salt and Benzene sulfonic acid, - oxibis[hexadecyl]-, disodium salt",65143-89-7,"The acute oral LD50 is >5000 mg/kg and the acute dermal LD50 is >2000 mg/kg, the highest doses examined. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/379cd30d-7327-4221-a37d-ecbed3fbddfd/documents/IUC5-5c8a8749-d34d-4946-be0f-7c38ff4897d1_8a9d375d-dc76-4e0c-a23f-5c41c41cf52f.html,,,,,, "3-(4,6-dimethoxy-1,3,5-triazin-2-yl)-7-fluoro-1,3-dihydro-2H-indol-2-one",1383706-71-5,"Acute toxicity: oral (rats, OECD TG 423): LD50: > 2000 mg/kg b.w.The acute oral toxicity to female Wistar rats of the test item was assessed. The test compound was formulated in tap water with the aid of PEG 400, the administration volume was 10 mL/kg body weight. The starting dose of the test item was 2000 mg/kg bw. According to the OECD guideline 423 the LD50 of the test item is > 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e32ede9-c37a-43fc-b35f-2bc7a4090e8d/documents/5746b7da-3b48-4b58-93e1-f2530a0a2e5b_28410d0f-7097-4af4-ad9f-5f515821c8af.html,,,,,, "3-(4,6-dimethoxy-1,3,5-triazin-2-yl)-7-fluoro-1,3-dihydro-2H-indol-2-one",1383706-71-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e32ede9-c37a-43fc-b35f-2bc7a4090e8d/documents/5746b7da-3b48-4b58-93e1-f2530a0a2e5b_28410d0f-7097-4af4-ad9f-5f515821c8af.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one",146939-27-7," In chronic studies (rat and dog, 6-mo and 1-yr) sedation was the primary drug-related clinical sign and was observed at all doses, with severity being dose related. [FDA]   As stated in CLP Guidance, where the same target organ toxicity of similar severity is observed after single and repeated exposure to a similar dose, it may be concluded that the toxicity is essentially an acute (i.e. single exposure) effect with no accumulation or exacerbation of the toxicity with repeated exposure. In such a case classification with STOT-SE only would be appropriate.   Since sedation and other CNS effects (reversible effects) has been observed both in acute and chronic, at all dose levels tested and these types of effects has been considered for the classification as STOT RE is not relevant.   Other types of adverse effects reported are less relevant and are inconclusive for the classification of the substance. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc1203c7-88a1-402d-9aca-0d08451cbfc7/documents/1190912e-da74-48a1-92e0-9c5dfe5f6ede_9f2f9ecd-e0e0-4d57-a374-3061b20b44d4.html,,,,,, "5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one",146939-27-7," The acute toxicity of the substance was tested in albino mice and Sprague-Dawley rats. The substance was administered to mice (strain nor specified) at doses of 500 and 2000 mg/kg p.o. (3/sex/groups) and 300, 500, and 1000 mg/kg i.p. (3M only). Rats received doses of 500 and 2000 mg/kg p.o. (3/sex) and 500 and 2000 mg/kg i.p. (3M only). Drug-related deaths occurred only in male mice at 1000 mg/kg i. p. Sedation was the primary clinical sign with both routes. CNS signs tended to have a more rapid onset and prolonged duration with i. p. dosing. No target organ for toxicity was identified. LD50's were calculated to be >2000 mg/kg p.o. in both mice and rats and >2000 mg/kg i.p. in rats, and 500-1000 mg/kg i.p. in mice. This study was not definitive due to the lack of a complete battery of measurements, of control groups, and the small n/group.   The available date are conclusive but not sufficient for the classification of the substance for acute oral toxicity. To assess dermal toxicity, ziprasidone was applied to intact skin at a single dose of 2000 mg for 24 hrs. Animals (n= 5) were examined 2 days after drug application. In the dermal study, no drug-related mortality or clinical signs or changes in body wt or food consumption were observed, nor were any signs if dermal irritation detected. The available date are conclusive but not sufficient for the classification of the substance for acute dermal toxicity ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc1203c7-88a1-402d-9aca-0d08451cbfc7/documents/f53f57d5-02b7-48b6-b723-a36ec2bc50a3_9f2f9ecd-e0e0-4d57-a374-3061b20b44d4.html,,,,,, "5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one",146939-27-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc1203c7-88a1-402d-9aca-0d08451cbfc7/documents/f53f57d5-02b7-48b6-b723-a36ec2bc50a3_9f2f9ecd-e0e0-4d57-a374-3061b20b44d4.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "5-[2-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]ethyl]-6-chloro-1,3-dihydro-2H-indol-2-one",146939-27-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc1203c7-88a1-402d-9aca-0d08451cbfc7/documents/f53f57d5-02b7-48b6-b723-a36ec2bc50a3_9f2f9ecd-e0e0-4d57-a374-3061b20b44d4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "7-fluoro-2,3-dihydro-1h-indol-2-one",71294-03-6,"Acute toxicity: oral (rats, OECD TG 423): LD50: ≥ 300 ≤ 2000 mg/kg b.w. The single-dose oral toxicity of the test item was performed according to the acute toxic class method (OECD 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris) in female Wistar rats.A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 3 hours after the treatment. The test item was administered formulated in DMSO at a dosing volume of 10 mL/kg bw.Initially, three females (assigned to Group 1) were treated at a dose level of 50 mg/kg bw. The test item caused mortality in one animal in this group. The second group (Group 2) was treated at the same dose level. In the absence of mortality in Group 2, Group 3 was dosed at 300 mg/kg bw. As no mortality was observed in this group, a confirmatory group (Group 4) was treated at the same dose level. No mortality was observed in Group 4 and, finally, Group 5 was dosed at the dose level of 2000 mg/kg bw. The test item caused mortality two of three animals in this dose level; therefore no further testing was required according to OECD 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris.According to the OECD guideline 423 the LD50 of the test item is between 300 and 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2c0ff0d-1998-4f28-a39c-71edcde8f5ac/documents/39434fa3-7e69-4c84-b461-6fc655acb6cd_d811ddf3-800f-4c49-89cb-01edcb9e9c23.html,,,,,, "2-[4′-[Difluoro(3,4,5-trifluorophenoxy)methyl]-3′,5′-difluoro[1,1′-biphenyl]-4-yl]-5-ethyltetrahydro-2H-pyran",787582-75-6," In a subacute toxicity study according to OECD TG 407, the test item was administered daily by oral gavage Wistar rats of both sexes at dose levels of 100, 300 and 1000 mg/kg body weight/day for a period of 28 days. The NOAEL was considered to be 1000 mg/kg body weight/day (reference 7.5.1 -1). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6912fe1-c91c-4a58-842f-07659b3308d6/documents/c7d574f4-a743-4866-8fb4-baa8149eca39_ce5fe746-4ed4-48a8-af73-2b31faec7143.html,,,,,, "2-[4′-[Difluoro(3,4,5-trifluorophenoxy)methyl]-3′,5′-difluoro[1,1′-biphenyl]-4-yl]-5-ethyltetrahydro-2H-pyran",787582-75-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6912fe1-c91c-4a58-842f-07659b3308d6/documents/c7d574f4-a743-4866-8fb4-baa8149eca39_ce5fe746-4ed4-48a8-af73-2b31faec7143.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-[4′-[Difluoro(3,4,5-trifluorophenoxy)methyl]-3′,5′-difluoro[1,1′-biphenyl]-4-yl]-5-ethyltetrahydro-2H-pyran",787582-75-6," One oral and one dermal acute toxicity study were conducted with the test item. Both limit studies showed no mortality, no body weight change and no signs of toxicity. Therefore, the following LD50 values were determined: oral LD50 (male/female) > 2000 mg/kg bw (reference 7.2.1 -1) dermal LD50 (male/female) > 2000 mg/kg bw (reference 7.2.3 -1) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6912fe1-c91c-4a58-842f-07659b3308d6/documents/IUC5-6648e118-66dc-4acb-82fd-f715478a25a6_ce5fe746-4ed4-48a8-af73-2b31faec7143.html,,,,,, "2-[4′-[Difluoro(3,4,5-trifluorophenoxy)methyl]-3′,5′-difluoro[1,1′-biphenyl]-4-yl]-5-ethyltetrahydro-2H-pyran",787582-75-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6912fe1-c91c-4a58-842f-07659b3308d6/documents/IUC5-6648e118-66dc-4acb-82fd-f715478a25a6_ce5fe746-4ed4-48a8-af73-2b31faec7143.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-[4′-[Difluoro(3,4,5-trifluorophenoxy)methyl]-3′,5′-difluoro[1,1′-biphenyl]-4-yl]-5-ethyltetrahydro-2H-pyran",787582-75-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6912fe1-c91c-4a58-842f-07659b3308d6/documents/IUC5-6648e118-66dc-4acb-82fd-f715478a25a6_ce5fe746-4ed4-48a8-af73-2b31faec7143.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 5-pentyloxan-2-one,875471-31-1," Oral LD50 > 2000 mg/kg bw (OECD 423, K, Rel.1, class method in rats) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36a2a68e-61f0-4701-8b2a-b73912214d73/documents/fb66346d-ee45-441b-83a9-b4b313ab30cc_e7066350-07b8-494b-b157-71eee6f79be4.html,,,,,, 5-pentyloxan-2-one,875471-31-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36a2a68e-61f0-4701-8b2a-b73912214d73/documents/fb66346d-ee45-441b-83a9-b4b313ab30cc_e7066350-07b8-494b-b157-71eee6f79be4.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, 2-hydroxy-1-(4-(4-(2-hydroxy-2-methylpropionyl)benzyl)phenyl)-2-methylpropan-1-one,474510-57-1,The study was conducted to a recognised testing guideline with GLP certification. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a8b2ff2-6b8d-466e-a998-880cd479b88a/documents/IUC5-e3acbc5c-542f-4f1b-a84c-bacf291ea30f_3caace5f-3ea9-48d5-adaa-ed584be92729.html,,,,,, 2-hydroxy-1-(4-(4-(2-hydroxy-2-methylpropionyl)benzyl)phenyl)-2-methylpropan-1-one,474510-57-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a8b2ff2-6b8d-466e-a998-880cd479b88a/documents/IUC5-e3acbc5c-542f-4f1b-a84c-bacf291ea30f_3caace5f-3ea9-48d5-adaa-ed584be92729.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat 2-hydroxy-1-(4-(4-(2-hydroxy-2-methylpropionyl)benzyl)phenyl)-2-methylpropan-1-one,474510-57-1, Studies conducted to recognised testing guidelines with GLP certification. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a8b2ff2-6b8d-466e-a998-880cd479b88a/documents/IUC5-79f29357-b98a-4b97-8c3c-d32889da11e7_3caace5f-3ea9-48d5-adaa-ed584be92729.html,,,,,, 2-hydroxy-1-(4-(4-(2-hydroxy-2-methylpropionyl)benzyl)phenyl)-2-methylpropan-1-one,474510-57-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a8b2ff2-6b8d-466e-a998-880cd479b88a/documents/IUC5-79f29357-b98a-4b97-8c3c-d32889da11e7_3caace5f-3ea9-48d5-adaa-ed584be92729.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-hydroxy-1-(4-(4-(2-hydroxy-2-methylpropionyl)benzyl)phenyl)-2-methylpropan-1-one,474510-57-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a8b2ff2-6b8d-466e-a998-880cd479b88a/documents/IUC5-79f29357-b98a-4b97-8c3c-d32889da11e7_3caace5f-3ea9-48d5-adaa-ed584be92729.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-hydroxy-2-methylpropionitrile,75-86-5,"Reliable data on repeated dose toxicity are available only for the inhalation route of exposure. Acute lethality appears to be the critical adverse health effect. Beside lethality and signs of irritation (red nasal discharge, clear nasal discharge, perioral wetness, encrustations) no substance related toxic effects were seen. Allowing for a very steep dose response curve, an NOAEL of 61.2 ppm 2-hydroxy-2-methylproanenitril (216 mg/m³ or 66 mg CN-/m, the highest concentration tested, can be defined from a reliable 14 week inhalation study in rats. Concentrations slightly overrun this NOAEL are already acute lethal. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3869fb3-fafa-4d19-8b9d-05ce19ac0165/documents/IUC5-cd51898e-85bc-4fbc-8119-fb1e283af31f_ef3dc0a0-5540-42d8-ba59-a99861799d62.html,,,,,, 2-hydroxy-2-methylpropionitrile,75-86-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3869fb3-fafa-4d19-8b9d-05ce19ac0165/documents/IUC5-cd51898e-85bc-4fbc-8119-fb1e283af31f_ef3dc0a0-5540-42d8-ba59-a99861799d62.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,216 mg/m3,, 2-hydroxy-2-methylpropionitrile,75-86-5,"Data for acute oral, dermal and inhalation toxicity are available. The substance is very toxic by all these exposure routes which is reflected in the legally binding harmonised classification as given in REGULATION (EC) No 1272/2008 Annex VI Table 3.1 (GHS): Acute tox 2*       H330 (oral)Acute tox 1        H310 (dermal)(Acute tox 2*       H300 (inhalation, vapour)) Based on the actual data this classification in annex VI, EU GHS, is too low. Data indicate the following:Acute tox 1       H300 (inhalation, vapour)and Table 3.2 (Annex I of Directive 67/548/EEC): T+; R26/27/28 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3869fb3-fafa-4d19-8b9d-05ce19ac0165/documents/IUC5-c28f6081-969c-4816-b044-39fe85a8585d_ef3dc0a0-5540-42d8-ba59-a99861799d62.html,,,,,, 2-hydroxy-2-methylpropionitrile,75-86-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3869fb3-fafa-4d19-8b9d-05ce19ac0165/documents/IUC5-c28f6081-969c-4816-b044-39fe85a8585d_ef3dc0a0-5540-42d8-ba59-a99861799d62.html,,oral,LD50,17 mg/kg bw,, 2-hydroxy-2-methylpropionitrile,75-86-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3869fb3-fafa-4d19-8b9d-05ce19ac0165/documents/IUC5-c28f6081-969c-4816-b044-39fe85a8585d_ef3dc0a0-5540-42d8-ba59-a99861799d62.html,,dermal,LD50,16 mg/kg bw,, 2-hydroxy-2-methylpropionitrile,75-86-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3869fb3-fafa-4d19-8b9d-05ce19ac0165/documents/IUC5-c28f6081-969c-4816-b044-39fe85a8585d_ef3dc0a0-5540-42d8-ba59-a99861799d62.html,,inhalation,discriminating conc.,223 mg/m3,, 2-hydroxy-3-(prop-2-enoyloxy)propyl 2-methyl-2-propylhexanoate,444649-70-1," Although the adverse effects observed in the kidney are specific to male rats and are not relevant for humans, the NOAEL of 100 mg/kg bw/day (based on increase in creatinine, phosphate and secondary degenerative changes in kidney) has been considered further for hazard assessment. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48046dfc-0bcc-4807-aa11-23825fb2c21f/documents/1081d108-1f38-4e3a-bfa6-fa77dd5f7a76_14d3c1a5-1ae1-473b-bd9b-00cfc48a14b8.html,,,,,, 2-hydroxy-3-(prop-2-enoyloxy)propyl 2-methyl-2-propylhexanoate,444649-70-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48046dfc-0bcc-4807-aa11-23825fb2c21f/documents/1081d108-1f38-4e3a-bfa6-fa77dd5f7a76_14d3c1a5-1ae1-473b-bd9b-00cfc48a14b8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 2-hydroxy-3-(prop-2-enoyloxy)propyl 2-methyl-2-propylhexanoate,444649-70-1," The oral LD50 of the test substance was determined to be >2,000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48046dfc-0bcc-4807-aa11-23825fb2c21f/documents/ddaa53a0-345c-4792-b917-6a9c1dac11ae_14d3c1a5-1ae1-473b-bd9b-00cfc48a14b8.html,,,,,, 2-hydroxy-3-(prop-2-enoyloxy)propyl 2-methyl-2-propylhexanoate,444649-70-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48046dfc-0bcc-4807-aa11-23825fb2c21f/documents/ddaa53a0-345c-4792-b917-6a9c1dac11ae_14d3c1a5-1ae1-473b-bd9b-00cfc48a14b8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-hydroxy-3-phenoxypropyl acrylate,16969-10-1," A Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test is available on 2-Hydroxy-3-phenoxypropyl acrylate. In this 28 -day repeated toxicity study, no adverse systemic effects were oberved at the highest dose of 100 mg/kg/day. This highest dose was selected based on the local effects observed in the preliminary study. Indeed, in the main study, local toxicity was observed in the stomach in females from 10 mg/kg/day and in males from 30 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26ff07d1-09c7-40c8-b49f-45274e7ad22e/documents/IUC5-080ad35f-218c-4ffe-bf14-4620626a90dc_ac0e2899-7fcf-4967-a718-26db61d50180.html,,,,,, 2-hydroxy-3-phenoxypropyl acrylate,16969-10-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26ff07d1-09c7-40c8-b49f-45274e7ad22e/documents/IUC5-080ad35f-218c-4ffe-bf14-4620626a90dc_ac0e2899-7fcf-4967-a718-26db61d50180.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 2-hydroxy-3-phenoxypropyl acrylate,16969-10-1, Acute toxicity potentiel of 2 -Hydroxy-3 -phenoxypropyl acrylate was evaluated by oral route only. The oral LD50 is higher than 2000 mg/kg in rat. No data is available by dermal route or by inhalation. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26ff07d1-09c7-40c8-b49f-45274e7ad22e/documents/IUC5-bf456457-f23b-47b0-ab4a-d1511905fdcf_ac0e2899-7fcf-4967-a718-26db61d50180.html,,,,,, 2-hydroxy-3-phenoxypropyl acrylate,16969-10-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26ff07d1-09c7-40c8-b49f-45274e7ad22e/documents/IUC5-bf456457-f23b-47b0-ab4a-d1511905fdcf_ac0e2899-7fcf-4967-a718-26db61d50180.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-hydroxy-4-(methylthio)butyronitrile,17773-41-0,Oral: LD50 = 48 mg/kg bw for rats (according to OECD Guideline 401)Inhalation: LC50 = 0.651 mg/l/4h for rats (similar to OECD Guideline 403) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5853407-f526-4f55-bb83-15a364d97287/documents/IUC5-2b636b1f-3a6a-4d21-b77a-709d26819813_7f1a5032-b4cf-49d9-a781-be74115d4128.html,,,,,, 2-hydroxy-4-(trifluoromethyl)benzoic acid,328-90-5," Repeated dose toxicity: oral - Key study. Sub-acute toxicity. Read-across from analogue substance. 60-day oral toxicity study in rats (no TG, no GLP). The analogue substance has a NOAEL > 50 mg/kg bw/day in rats. Based on the available information for the read-across approach, the target substance has a NOAEL > 41.5 mg/kg bw/day in rats. - Key study. Chronic toxicity. Read-across from analogue substance. 52-week oral toxicity study in rats (13-wk recovery period), similar to OECD 452, GLP study. The analogue substance has a NOEL ≥ 25 mg/kg bw/day in rats. Based on the available information for the read-across approach, the target substance has a chronic NOEL ≥ 20.8 mg/kg bw/day in rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/488b4289-206b-43a5-8054-8bc2f4c8ba57/documents/b8b91b97-4081-4431-aa60-e4a745d99c5c_57f695b3-3133-4911-9dd6-9f2cbd5f2691.html,,,,,, 2-hydroxy-4-(trifluoromethyl)benzoic acid,328-90-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/488b4289-206b-43a5-8054-8bc2f4c8ba57/documents/b8b91b97-4081-4431-aa60-e4a745d99c5c_57f695b3-3133-4911-9dd6-9f2cbd5f2691.html,Chronic toxicity – systemic effects,oral,NOAEL,20.77 mg/kg bw/day,,rat 2-hydroxy-4-(trifluoromethyl)benzoic acid,328-90-5," Acute oral toxicity: Key study. OECD 423. GLP study. The oral LD50 was determined to be between 200-500 mg/kg bw in rats. Acute dermal toxicity: Key study. OECD 402 (Fixed Dose Procedure), GLP study. The dermal LD50 was determined to be between 2000-5000 mg/kg bw in rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/488b4289-206b-43a5-8054-8bc2f4c8ba57/documents/aac2f027-f4dc-4eb2-8be3-881579128cfe_57f695b3-3133-4911-9dd6-9f2cbd5f2691.html,,,,,, 2-hydroxy-4-(trifluoromethyl)benzoic acid,328-90-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/488b4289-206b-43a5-8054-8bc2f4c8ba57/documents/aac2f027-f4dc-4eb2-8be3-881579128cfe_57f695b3-3133-4911-9dd6-9f2cbd5f2691.html,,oral,LD50,200 mg/kg bw,adverse effect observed, 2-hydroxy-4-(trifluoromethyl)benzoic acid,328-90-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/488b4289-206b-43a5-8054-8bc2f4c8ba57/documents/aac2f027-f4dc-4eb2-8be3-881579128cfe_57f695b3-3133-4911-9dd6-9f2cbd5f2691.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2'-hydroxyacetophenone,118-93-4,In three acute oral toxicity studies LD50 values of greater than 2000 mg/kg bw were determined for rats. A dermal LD50 of greater than 2000 mg/kg bw was determined for acute dermal toxicity in rabbits based on two studies. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18e56522-b0af-4508-81d1-d4703f3fe699/documents/IUC5-f1d22dbc-8722-48cd-bf47-9ea423ef2ea2_c8817fe4-85fc-4eca-b640-5426e27dfb94.html,,,,,, 2'-hydroxyacetophenone,118-93-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18e56522-b0af-4508-81d1-d4703f3fe699/documents/IUC5-f1d22dbc-8722-48cd-bf47-9ea423ef2ea2_c8817fe4-85fc-4eca-b640-5426e27dfb94.html,,oral,LD50,"2,700 mg/kg bw",no adverse effect observed, 2'-hydroxyacetophenone,118-93-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18e56522-b0af-4508-81d1-d4703f3fe699/documents/IUC5-f1d22dbc-8722-48cd-bf47-9ea423ef2ea2_c8817fe4-85fc-4eca-b640-5426e27dfb94.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-hydroxyethyl [(1R,2S,5R)-2-isopropyl-5-methyl-cyclohexyl] carbonate",156324-78-6," NOAEL (28 days, male rat, oral) = 150 mg/kg bw/day (subacute)(OECD 407; GLP compliant) NOAEL (28 days, female rat, oral) = 1000 mg/kg bw/day (subacute)(OECD 407; GLP compliant) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee5a88cc-ed5a-4914-b6dd-5b2689a4fbc1/documents/61aa6bfa-3fd3-41cd-a71e-0c3a10d1b12e_7844dd83-659e-4a28-ad5d-78db0e5a0787.html,,,,,, "2-hydroxyethyl [(1R,2S,5R)-2-isopropyl-5-methyl-cyclohexyl] carbonate",156324-78-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee5a88cc-ed5a-4914-b6dd-5b2689a4fbc1/documents/61aa6bfa-3fd3-41cd-a71e-0c3a10d1b12e_7844dd83-659e-4a28-ad5d-78db0e5a0787.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "2-hydroxyethyl [(1R,2S,5R)-2-isopropyl-5-methyl-cyclohexyl] carbonate",156324-78-6, Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 401; GLP; male and female rats) Acute dermal toxicity: LD50 > 2000 mg/kg bw (OECD 402; GLP; male and female rats) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee5a88cc-ed5a-4914-b6dd-5b2689a4fbc1/documents/b8b56ffd-b723-4de6-b4ae-29ddff8dc68a_7844dd83-659e-4a28-ad5d-78db0e5a0787.html,,,,,, "2-hydroxyethyl [(1R,2S,5R)-2-isopropyl-5-methyl-cyclohexyl] carbonate",156324-78-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee5a88cc-ed5a-4914-b6dd-5b2689a4fbc1/documents/b8b56ffd-b723-4de6-b4ae-29ddff8dc68a_7844dd83-659e-4a28-ad5d-78db0e5a0787.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-hydroxyethyl [(1R,2S,5R)-2-isopropyl-5-methyl-cyclohexyl] carbonate",156324-78-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee5a88cc-ed5a-4914-b6dd-5b2689a4fbc1/documents/b8b56ffd-b723-4de6-b4ae-29ddff8dc68a_7844dd83-659e-4a28-ad5d-78db0e5a0787.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-hydroxy-N-1H-1,2,4-triazol-3-ylbenzamide",36411-52-6," The Acute Oral Toxicity in the Rat – Fixed Dose Procedure (WK90WT, Envigo Research Limited) study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System − Unclassified). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4fafe96-b6ec-4742-8510-801b19296754/documents/018b09ee-0b60-459e-b564-ea8329126346_7ed4e412-92d9-4941-aac5-a9ce8ac41f33.html,,,,,, 2-hydroxynaphthalene-1-carbaldehyde [(2-hydroxy-1-naphthyl)methylene]hydrazone,2387-03-3,Repeated dose toxicity: Oral The toxicity of 2-hydroxynaphthalene-1-carbaldehyde [(2-hydroxy-1-naphthyl)methylene]hydrazone after repeated administration by oral route was estimated using QSAR Toolbox 3.3.The no observed effect level (NOEL) for 2-hydroxynaphthalene-1-carbaldehyde [(2-hydroxy-1-naphthyl)methylene]hydrazone in a 13 week study in F344 rats was estimated to be 305.7 mg/kg bw/day. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/522fcd4a-acab-47af-a7ef-cee0faa98a2a/documents/IUC5-887fe1a4-5222-4bdf-89e9-cdc78d549b82_5d9aa747-130b-492b-9d98-b8fa5da4d162.html,,,,,, 2-hydroxynaphthalene-1-carbaldehyde [(2-hydroxy-1-naphthyl)methylene]hydrazone,2387-03-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/522fcd4a-acab-47af-a7ef-cee0faa98a2a/documents/IUC5-887fe1a4-5222-4bdf-89e9-cdc78d549b82_5d9aa747-130b-492b-9d98-b8fa5da4d162.html,Chronic toxicity – systemic effects,oral,NOAEL,305.7 ,,rat 2-hydroxynaphthalene-1-carbaldehyde [(2-hydroxy-1-naphthyl)methylene]hydrazone,2387-03-3,"The test substance Yellow 101 is not likely to be toxic to rats and rabbits by oral, inhalation and dermal route, respectively. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/522fcd4a-acab-47af-a7ef-cee0faa98a2a/documents/IUC5-3e3e0031-1f6b-4a1f-ad2c-ca3d22ecc096_5d9aa747-130b-492b-9d98-b8fa5da4d162.html,,,,,, 2-hydroxynaphthalene-1-carbaldehyde [(2-hydroxy-1-naphthyl)methylene]hydrazone,2387-03-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/522fcd4a-acab-47af-a7ef-cee0faa98a2a/documents/IUC5-3e3e0031-1f6b-4a1f-ad2c-ca3d22ecc096_5d9aa747-130b-492b-9d98-b8fa5da4d162.html,,oral,LD50,"4,600 mg/kg bw",no adverse effect observed, 2-hydroxynaphthalene-1-carbaldehyde [(2-hydroxy-1-naphthyl)methylene]hydrazone,2387-03-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/522fcd4a-acab-47af-a7ef-cee0faa98a2a/documents/IUC5-3e3e0031-1f6b-4a1f-ad2c-ca3d22ecc096_5d9aa747-130b-492b-9d98-b8fa5da4d162.html,,dermal,LD50,"4,247 mg/kg bw",no adverse effect observed, "2-hydroxypropyl [(1R,2S,5R)-2-isopropyl-5-methyl-cyclohexyl] carbonate",260781-16-6," NOAEL (28 days, rat, oral) = 150 mg/kg bw/day (subacute)(OECD 407; GLP compliant) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c26619fd-f8c1-42e5-b552-f95d5979cd59/documents/b595e570-f196-44bc-bcef-d5163e08488b_69307ce6-4a1e-4aa2-af38-296eef598fc9.html,,,,,, "2-hydroxypropyl [(1R,2S,5R)-2-isopropyl-5-methyl-cyclohexyl] carbonate",260781-16-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c26619fd-f8c1-42e5-b552-f95d5979cd59/documents/b595e570-f196-44bc-bcef-d5163e08488b_69307ce6-4a1e-4aa2-af38-296eef598fc9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "2-hydroxypropyl [(1R,2S,5R)-2-isopropyl-5-methyl-cyclohexyl] carbonate",260781-16-6, Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 401; GLP; male and female rats) Acute dermal toxicity: LD50 > 2000 mg/kg bw (OECD 402; GLP; male and female rats) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c26619fd-f8c1-42e5-b552-f95d5979cd59/documents/0bad6230-a832-4d19-8973-12c18e5d6e6d_69307ce6-4a1e-4aa2-af38-296eef598fc9.html,,,,,, "2-hydroxypropyl [(1R,2S,5R)-2-isopropyl-5-methyl-cyclohexyl] carbonate",260781-16-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c26619fd-f8c1-42e5-b552-f95d5979cd59/documents/0bad6230-a832-4d19-8973-12c18e5d6e6d_69307ce6-4a1e-4aa2-af38-296eef598fc9.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-hydroxypropyl [(1R,2S,5R)-2-isopropyl-5-methyl-cyclohexyl] carbonate",260781-16-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c26619fd-f8c1-42e5-b552-f95d5979cd59/documents/0bad6230-a832-4d19-8973-12c18e5d6e6d_69307ce6-4a1e-4aa2-af38-296eef598fc9.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-hydroxypyridine 1-oxide,13161-30-3, Acute oral toxicity: LD50 was estimated to be 2225 mg/kg bw when Wistar male and female rats were orally exposed with 2-hydroxy-1λ⁵-pyridin-1-one. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d7ded73-edc0-40fa-b056-410c87a18173/documents/12d230c0-921c-46be-be95-3cff69b61381_9e907eab-c7d6-4da2-aedc-dcc57b930d45.html,,,,,, 2-hydroxypyridine 1-oxide,13161-30-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d7ded73-edc0-40fa-b056-410c87a18173/documents/12d230c0-921c-46be-be95-3cff69b61381_9e907eab-c7d6-4da2-aedc-dcc57b930d45.html,,oral,LD50,"2,225 mg/kg bw",no adverse effect observed, "2H-Pyran-4-ol, tetrahydro-4-methyl-2-(2-methylpropyl)-, 4-acetate",131796-64-0," Oral: The discriminating dose of the test substance in rat was ≥ 2000 mg/kg bw (BASF SE, 2017). Dermal: The discriminating dose of the test substance in rat was ≥ 2000 mg/kg bw (BASF SE, 2017). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b99e74f5-39bd-4653-8954-107116fd1b74/documents/664120d8-cecd-42cc-b2e1-a6b7ba39b942_713328ee-875a-4edb-8ebf-be14ef4b7aff.html,,,,,, "2H-Pyran-4-ol, tetrahydro-4-methyl-2-(2-methylpropyl)-, 4-acetate",131796-64-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b99e74f5-39bd-4653-8954-107116fd1b74/documents/664120d8-cecd-42cc-b2e1-a6b7ba39b942_713328ee-875a-4edb-8ebf-be14ef4b7aff.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2H-Pyran-4-ol, tetrahydro-4-methyl-2-(2-methylpropyl)-, 4-acetate",131796-64-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b99e74f5-39bd-4653-8954-107116fd1b74/documents/664120d8-cecd-42cc-b2e1-a6b7ba39b942_713328ee-875a-4edb-8ebf-be14ef4b7aff.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-isobutyl-4-vinyl-1,3-dioxolane",1411949-02-4," Oral: In an acute oral toxicity study according to OECD Guideline 423 in Sprague-Dawley rats, an LD50 of 2,500 mg/kg bw was determined. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c50f78ab-bcd5-4837-ba25-fa49f1522dab/documents/ea2c5aed-6266-4b52-affe-88b941fa4884_65a43cf8-7037-4d40-a58e-4baf73ece62f.html,,,,,, "2-isobutyl-4-vinyl-1,3-dioxolane",1411949-02-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c50f78ab-bcd5-4837-ba25-fa49f1522dab/documents/ea2c5aed-6266-4b52-affe-88b941fa4884_65a43cf8-7037-4d40-a58e-4baf73ece62f.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, 2-isopropoxyethanol,109-59-1," ORAL rat (28 day studies) - LOAEL=30mg/kg, 195mg/kg (effects seen at lowest dose) INHALATION - Rat, 6 month NOAEL=25ppm (all effects), 100ppm (excluding haemolytic effects) - Rabbit 6 month NOAEL=50ppm (200ppm excluding male kidney weight effects) - Dog 6 month NOAEL=50ppm (LOAEL heart effects at 200ppm) - Guinea pigs (6 months)=50ppm (LOAEL heart weight, clin chemistry females, body weight males - Rat (5 weeks) LOAEL=390ppm - Rat (4 weeks) NOAEL=30ppm - Rat (2 weeks) NOAEL=300ppm - Rat (2 week) NOAEL=100ppm Note: 100ppm = 433mg/m3 The highest NOAEL observed that is lower than a LOAEL is 100ppm. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb32efc9-929a-40db-8515-a3dc2fab4e74/documents/IUC5-d4a97924-e48c-42d4-a2b1-cb04e02f436a_af62a167-85fc-4161-a5c6-e020ea0fa392.html,,,,,, 2-isopropoxyethanol,109-59-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb32efc9-929a-40db-8515-a3dc2fab4e74/documents/IUC5-d4a97924-e48c-42d4-a2b1-cb04e02f436a_af62a167-85fc-4161-a5c6-e020ea0fa392.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,30 mg/kg bw/day,,rat 2-isopropoxyethanol,109-59-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb32efc9-929a-40db-8515-a3dc2fab4e74/documents/IUC5-d4a97924-e48c-42d4-a2b1-cb04e02f436a_af62a167-85fc-4161-a5c6-e020ea0fa392.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,433 mg/m3,,rat 2-isopropoxyethanol,109-59-1," ORAL ROUTE: Rat LD50 values: iPrGE: >2000mg/kg, Klimisch 4 study LD50=5.66mL/kg INHALATION Rat: LCLo >160ppm.  LC50 values (4hrs) : >3500ppm, (SVP) <4000ppm Mouse: LC50 (7hrs): 1930ppm (8.2mg/L) DERMAL Rabbit LD50: isoproxy ethanol: 1440mg/kg, n-propoxyethanol 1337mg/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb32efc9-929a-40db-8515-a3dc2fab4e74/documents/IUC5-9c7105cd-2426-44d9-b4ee-28f0ac0dafc2_af62a167-85fc-4161-a5c6-e020ea0fa392.html,,,,,, 2-isopropoxyethyl salicylate,79915-74-5," A sub-acute repeated dose toxicity study, including screening for reproduction/ developmental effects, performed with Sakura Salicylate according to OECD/EC guidelines and GLP principles is available. The results of two preliminary studies are included as supplementary data. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee0e445e-2c0a-47ac-b8dc-798363c326e0/documents/8a80a958-8cfd-4d09-b9bf-f45523387338_7f462705-19ed-4c2c-9652-0aea465dc575.html,,,,,, 2-isopropoxyethyl salicylate,79915-74-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee0e445e-2c0a-47ac-b8dc-798363c326e0/documents/8a80a958-8cfd-4d09-b9bf-f45523387338_7f462705-19ed-4c2c-9652-0aea465dc575.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 2-isopropoxyethyl salicylate,79915-74-5," Two studies are available that address the acute toxicity of Sakura Salicylate (2-Isopropoxyethyl salicylate), an acute oral and an acute dermal toxicity study. Both studies were conducted according to OECD guidelines and GLP principles (Klimisch 1 studies). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee0e445e-2c0a-47ac-b8dc-798363c326e0/documents/a0d2b9b8-dae5-40ab-abd9-564926d2225a_7f462705-19ed-4c2c-9652-0aea465dc575.html,,,,,, 2-isopropoxyethyl salicylate,79915-74-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee0e445e-2c0a-47ac-b8dc-798363c326e0/documents/a0d2b9b8-dae5-40ab-abd9-564926d2225a_7f462705-19ed-4c2c-9652-0aea465dc575.html,,oral,LD50,300 mg/kg bw,adverse effect observed, 2-isopropoxyethyl salicylate,79915-74-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee0e445e-2c0a-47ac-b8dc-798363c326e0/documents/a0d2b9b8-dae5-40ab-abd9-564926d2225a_7f462705-19ed-4c2c-9652-0aea465dc575.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,3-bis(methoxymethyl)-2,6-dimethylheptane",129228-11-1, The LD50 is above 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88b7bbba-6fbb-45ce-a2dd-2e23350ff616/documents/ce8a7ef6-5a3e-4bd6-9ee2-93652217b183_0d9fc2bb-ddd0-4b1d-95ec-19b056e39b4f.html,,,,,, "3,3-bis(methoxymethyl)-2,6-dimethylheptane",129228-11-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88b7bbba-6fbb-45ce-a2dd-2e23350ff616/documents/ce8a7ef6-5a3e-4bd6-9ee2-93652217b183_0d9fc2bb-ddd0-4b1d-95ec-19b056e39b4f.html,,oral,LD50,"2,000 mg/kg bw",, 2-Methoxy-4-methylphenyl methyl carbonate,132638-45-0," Oral: NOAEL (rat): 650 mg/kg bw/day ; male/female, OECD TG 407, 2012 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/95b8a578-f001-4947-8b3e-d999ac61a95b/documents/ffa59fcc-caa4-43a7-aade-077dcdb3e487_7eac6b71-8c65-4a3b-9f3d-e99e97a51e55.html,,,,,, 2-Methoxy-4-methylphenyl methyl carbonate,132638-45-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/95b8a578-f001-4947-8b3e-d999ac61a95b/documents/ffa59fcc-caa4-43a7-aade-077dcdb3e487_7eac6b71-8c65-4a3b-9f3d-e99e97a51e55.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,650 mg/kg bw/day,,rat 2-Methoxy-4-methylphenyl methyl carbonate,132638-45-0," Oral: measured LD50 > 2000 mg/kg bw and the estimated LD50 cut-off was considered to be > 2000 and < 5000 mg/kg bw, female rat, OECD TG 420, 2012 Inhalation: LC50 (male/female): > 3.52 mg/L, mean maximum achievable atmosphere concentration, male/female rat, OECD TG 436, 2012 Dermal: measured LD50 > 2000 mg/kg bw and the estimated LD50 cut-off value was considered to be > 5000 mg/kg bw, male/female rat, OECD TG 402, 2012 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95b8a578-f001-4947-8b3e-d999ac61a95b/documents/d176f34d-22e8-4ba2-a92c-da229082f1ed_7eac6b71-8c65-4a3b-9f3d-e99e97a51e55.html,,,,,, 2-Methoxy-4-methylphenyl methyl carbonate,132638-45-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95b8a578-f001-4947-8b3e-d999ac61a95b/documents/d176f34d-22e8-4ba2-a92c-da229082f1ed_7eac6b71-8c65-4a3b-9f3d-e99e97a51e55.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-Methoxy-4-methylphenyl methyl carbonate,132638-45-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95b8a578-f001-4947-8b3e-d999ac61a95b/documents/d176f34d-22e8-4ba2-a92c-da229082f1ed_7eac6b71-8c65-4a3b-9f3d-e99e97a51e55.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-Methoxy-4-methylphenyl methyl carbonate,132638-45-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95b8a578-f001-4947-8b3e-d999ac61a95b/documents/d176f34d-22e8-4ba2-a92c-da229082f1ed_7eac6b71-8c65-4a3b-9f3d-e99e97a51e55.html,,inhalation,discriminating conc.,"3,520 mg/m3",no adverse effect observed, 2-methoxy-5-nitroanilinium chloride,67827-72-9," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target substance 2-methoxy-5-nitroanilinium chloride (67827-72-9) was estimated to be 705.66 mg/kg bw,and for differentstudies available on the structurally similar read across substance 1-methoxy-2-methyl-4-nitrobenzene (99-53-6) was considered to be 390 mg/kg bw and for 3-nitrobenzoic acid (121-92-6) was considered to be 1820 mg/kg bw. All these studies concluded that the LD50 value is between 300-2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-methoxy-5-nitroanilinium chloride (67827-72-9) can be classified as category IV of acute oral toxicity. Acute Inhalation Toxicity:  2-methoxy-5-nitroanilinium chloride (67827-72-9) has very low vapor pressure (1.63E-006 Pa.).So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver. Acute Dermal Toxicity: In Acute dermal toxicity, LD50 value was predicted based on OECD QSAR toolbox for target substance 2-methoxy-5-nitroanilinium chloride (67827-72-9) was estimated to be 7228.03 mg/kg bw,and for differentstudies available on structurally similar read across substance 3'-Nitroacetophenone (121-89-1). All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-methoxy-5-nitroanilinium chloride (67827-72-9) cannot be classified for acute dermal toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15f13738-e0cb-4916-9de8-9b4fa47a24da/documents/b593e0ca-3ff2-4d89-a3a2-aa7a6eff79ad_7c4e46a8-7b81-4ad7-b66f-202475edaf6d.html,,,,,, 2-methoxy-5-nitroanilinium chloride,67827-72-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15f13738-e0cb-4916-9de8-9b4fa47a24da/documents/b593e0ca-3ff2-4d89-a3a2-aa7a6eff79ad_7c4e46a8-7b81-4ad7-b66f-202475edaf6d.html,,oral,LD50,705.66 mg/kg bw,no adverse effect observed, 2-methoxy-5-nitroanilinium chloride,67827-72-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15f13738-e0cb-4916-9de8-9b4fa47a24da/documents/b593e0ca-3ff2-4d89-a3a2-aa7a6eff79ad_7c4e46a8-7b81-4ad7-b66f-202475edaf6d.html,,dermal,LD50,"3,128.45 mg/kg bw",, 2'-methoxyacetoacetanilide,92-15-9,"KEY STUDY (KEY_401_1991_HRC_90339D/LZA 38/AC), LD50 female rat (= most sensitive sex): 1635 mg/kg bwKEY STUDY (KEY_Met-Hb_1978_BASF_11.07.78 (dd)), LD50 male and female cat (= most sensitive species): >25 and <200 mg/kg bwNON-KEY STUDY (NON KEY_401_1973_Consultox Lab Ltd_CL 73:91:889), LD50 female rat: ca. 2500 mg/kg bwNON-KEY STUDY (NON KEY_401_1978_BASF_11.07.78 (dd)): LD50 rat: ca. 5500 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d3662c0-8485-47d4-a001-fff449a0c4e9/documents/IUC5-c564d2d4-5abe-4bfd-8429-16b974a53042_5a50b201-2e24-4223-a85a-e06e44864db2.html,,,,,, 2'-methoxyacetoacetanilide,92-15-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d3662c0-8485-47d4-a001-fff449a0c4e9/documents/IUC5-c564d2d4-5abe-4bfd-8429-16b974a53042_5a50b201-2e24-4223-a85a-e06e44864db2.html,,oral,LD50,"1,635 mg/kg bw",, 2-methoxybenzyl alcohol,612-16-8," Prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound 2-methoxybenzyl alcohol (612-16-8).The study assumed the use of male and female Wistar rats in chronic study of 2 years. No significant alterations were noted at the dose level of 281.0mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for 2-methoxybenzyl alcohol is considered to be 281.0mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3836aec5-11ff-46f5-8514-5087442ab173/documents/34dd6c8b-95f3-435c-aa08-6f87a9028c0f_66d50472-f4ca-470f-8a26-5ccaeda61036.html,,,,,, 2-methoxybenzyl alcohol,612-16-8,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3836aec5-11ff-46f5-8514-5087442ab173/documents/34dd6c8b-95f3-435c-aa08-6f87a9028c0f_66d50472-f4ca-470f-8a26-5ccaeda61036.html,Chronic toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat 2-methoxybenzyl alcohol,612-16-8," Acute oral toxicity:  Acute oral toxicity dose (LD50) of 2-Methoxybenzyl alcohol (CAS no: 612-16-8) was predicted based on OECD QSAR toolbox 1707 mg/kg bw and different studies available on structurally similar read across substances Benzyl alcohol (100-51-6) 1230 mg/kg bw and 4-methoxybenzyl alcohol (105-13-5) 1200 mg/kg bw. All these studies concluded that the LD50 value is between 300-2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-Methoxybenzyl alcohol can be classified as category IV of acute oral toxicity. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for 2-Methoxybenzyl alcohol (CAS no: 612-16-8) was predicted based on OECD QSAR toolbox 2248 mg/kg bwand differentstudies available for the structurally similar read across substance Phenoxyethanol (122-99-6) 13000 mg/kg bw and 4-methoxybenzyl alcohol (105-13-5) 3000 mg/kg bw. All these studies concluded that the LD50 value is>2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-Methoxybenzyl alcohol can be classified as category V of acute dermal toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3836aec5-11ff-46f5-8514-5087442ab173/documents/2d1f052b-c1fc-4f5a-a1b3-8d75de597bff_66d50472-f4ca-470f-8a26-5ccaeda61036.html,,,,,, 2-methoxybenzyl alcohol,612-16-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3836aec5-11ff-46f5-8514-5087442ab173/documents/2d1f052b-c1fc-4f5a-a1b3-8d75de597bff_66d50472-f4ca-470f-8a26-5ccaeda61036.html,,oral,LD50,"1,707 mg/kg bw",adverse effect observed, 2-methoxybenzyl alcohol,612-16-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3836aec5-11ff-46f5-8514-5087442ab173/documents/2d1f052b-c1fc-4f5a-a1b3-8d75de597bff_66d50472-f4ca-470f-8a26-5ccaeda61036.html,,dermal,LD50,"2,248 mg/kg bw",no adverse effect observed, 2-methoxyethyl acetoacetate,22502-03-0,"A study was carried out according to EU Method B.1 and OECD Guideline 401 (Acute Oral Toxicity) on Albino Wistar rats. 4 groups of 4 rats (2 male, 2 female) for Dose-Range-Finding and 1 group of 10 rats (5 male, 5 female) for the main study were treated by gavage with doses of 50, 250, 1250 and 5000 mg/kg in the pretest and with 5000 mg/kg in the main study. The LD50 was determined to be ca. 5000 mg/kg for both sexes. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/342f3123-4d1a-4095-ba52-b70c339e6b87/documents/IUC5-081466b4-cb66-448f-8b42-db3acf1753aa_75fc9a89-33b9-4a82-9112-3cf96c532662.html,,,,,, 2-methoxyethyl cyanoacetate,10258-54-5,"A study similar or equivalent to EU Method B.1 and OECD Guideline 401 (Acute toxicity oral) was carried out. Groups of fasted young albino rats (5 male/5 female per dose group) were given a single oral dose (gavage) of 2000, 4000, 5000, 6300, 8000, 16000 mg/kg bw and observed daily for 14 days. The obtained oral LD50 for males was 4700 mg/kg bw (95% C.I. 4100 – 550 mg/kg bw) and females was 4300 mg/kg bw (95% C.I. 3900 – 4700 mg/kg bw). The LD0 obtained for males and females was 2000 mg/kg bw . The LD100 for males was 6300 mg/kg bw and for females 5000 mg/kg bw. The test item was considered practically non-toxic. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb35f2ac-a5dc-43fa-9bd0-61375129b7b5/documents/IUC5-b5977fff-a6d2-4791-bde9-9d5c470800b0_aa0a398b-6854-4201-b69c-7083de6c6c17.html,,,,,, 2-methoxyethyl cyanoacetate,10258-54-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb35f2ac-a5dc-43fa-9bd0-61375129b7b5/documents/IUC5-b5977fff-a6d2-4791-bde9-9d5c470800b0_aa0a398b-6854-4201-b69c-7083de6c6c17.html,,oral,LD50,"4,300 mg/kg bw",no adverse effect observed, 2-methoxyethyl methacrylate,6976-93-8," subacute NOAEL = 29.5 mg/kg bw/d (rat) (read-across from 2 -methoxyethanol); BMD analysis and biomarker of testicular damage; not a full study, 10 d only, rather mechanistic study, not used for DNEL derivation ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/936aa1a8-2fd6-4212-ae05-c2bb78858675/documents/IUC5-17af6411-5bc6-4b13-9354-94f9dc0f55d3_1d1682bc-11e9-4782-b3a3-7bd8dd4cf633.html,,,,,, 2-methoxyethyl methacrylate,6976-93-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/936aa1a8-2fd6-4212-ae05-c2bb78858675/documents/IUC5-17af6411-5bc6-4b13-9354-94f9dc0f55d3_1d1682bc-11e9-4782-b3a3-7bd8dd4cf633.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,29.5 mg/kg bw/day,,rat 2-methoxyethyl methacrylate,6976-93-8,"Acute oral toxicity:Oral LD50 (rat, male/female) > 2000 mg/kg bw; OECD Guideline 401; GLP compliant, RL1Acute dermal toxicity:Dermal LD50 (rat, male/female) > 2000 mg/kg bw; OECD Guideline 402; GLP compliant, RL1; read-across from ETMA ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/936aa1a8-2fd6-4212-ae05-c2bb78858675/documents/IUC5-a5086aca-7a4f-4268-816b-660d172ff952_1d1682bc-11e9-4782-b3a3-7bd8dd4cf633.html,,,,,, 2-methoxyethyl methacrylate,6976-93-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/936aa1a8-2fd6-4212-ae05-c2bb78858675/documents/IUC5-a5086aca-7a4f-4268-816b-660d172ff952_1d1682bc-11e9-4782-b3a3-7bd8dd4cf633.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-methoxyethyl methacrylate,6976-93-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/936aa1a8-2fd6-4212-ae05-c2bb78858675/documents/IUC5-a5086aca-7a4f-4268-816b-660d172ff952_1d1682bc-11e9-4782-b3a3-7bd8dd4cf633.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-methoxy-N-[2-nitro-5-(phenylthio)phenyl]acetamide,63470-85-9,"Acute Oral toxicity study in male and female Wistar rats Testing facility: RCC Ltd, SwitzerlandStudy no. 842956 performed on July 29,2002 Acute Dermal toxicity study in male and female Wistar rats Testing facility: RCC Ltd, SwitzerlandStudy no. 842957 performed on May 6, 2002. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0775feb-6a14-49c3-a939-2727e5f18234/documents/IUC5-1b0df07e-3d75-4245-9133-cf03d0de4da7_dff8add8-6c0d-409e-b1aa-04be78a87bba.html,,,,,, "2-methyl-1,4-phenylene-bis[4-(6-acryloyloxyhexyloxy)benzoate]",125248-71-7,"Acute oral: The LD50 value of the test item for males and females, after an observation period of 15 days, was determined to be > 2000 mg/kg bw according to OECD Guideline 401. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ca0d5e1-e072-4a32-9782-d6934e26bd41/documents/f018d611-94e3-482b-ac91-1cf3f81866ba_b9a1d26b-e62a-429e-b64f-0aaaad1395b7.html,,,,,, "2-methyl-1,4-phenylene-bis[4-(6-acryloyloxyhexyloxy)benzoate]",125248-71-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ca0d5e1-e072-4a32-9782-d6934e26bd41/documents/f018d611-94e3-482b-ac91-1cf3f81866ba_b9a1d26b-e62a-429e-b64f-0aaaad1395b7.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-methyl-1-heptanol,60435-70-3,"A read across from a reliable 13 week dietary study in rats using hexan-1-ol reported a NOAEL of 1127 mg/kg (Scientific Associates Inc., 1966). The results of this key study are supported by a reliable three week feeding study in rats using hexan-1-ol which reported a NOAEL of approximately 1000 mg/kg bw/day (Moody 1978 ). ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6bc545a2-fd57-409b-bf03-eb824ec7011c/documents/IUC5-ad670310-0f64-42f1-aa2b-83a83093f9ff_f01f2355-6a7a-43ca-a32e-0c214fd27454.html,,,,,, 2-methyl-1-heptanol,60435-70-3,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6bc545a2-fd57-409b-bf03-eb824ec7011c/documents/IUC5-ad670310-0f64-42f1-aa2b-83a83093f9ff_f01f2355-6a7a-43ca-a32e-0c214fd27454.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,127 mg/kg bw/day",, 2-methyl-1-heptanol,60435-70-3,"No measured data are available for 2-methyl-1-heptanol so the data have been read-across from a structural analogue, the linear isomer octan-1-ol. The acute oral key study in rat reports an LD50 of >5000 mg/kg for 1-octanol when applied as an aqueous solution (Henkel 1981; rel 2). The LD50 value of >5600 mg/m3 is reported in the key inhalation study in response to a 4 hour exposure to vapour (Amoco 1988; rel 2). The key study for acute dermal toxicity in rabbit found the LD50 value to be 2000-4000 mg/kg (Scientific Associates 1976; rel 2). ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6bc545a2-fd57-409b-bf03-eb824ec7011c/documents/IUC5-51e51b3a-34c1-4507-9ebe-a788fa7dc552_f01f2355-6a7a-43ca-a32e-0c214fd27454.html,,,,,, 2-methyl-2H-isothiazol-3-one hydrochloride,26172-54-3,"Acute oral toxicity This study was conducted to assess the acute toxicity of the test article, following a single oral administration to a small number of rats. The study design provides information for hazard assessment and classification and enables a chemical to be assigned to toxicity classes but severely restricts animal usage.   Individual female rats were dosed sequentially at the following dose levels until one of the stopping criteria (as defined in OECD 425) was met: 175, 550, 175, 550, 175 and 55 mg/kg bw. The test article was dispersed in purified water and administered at a dose volume of 10 mL/kg. Surviving animals were killed on Day 15 and all animals subsequently underwent a full necropsy.   Both animals dosed at 550 mg/kg bw were killed in extremis within 1 to 4 hours of dosing. One animal dosed at 175 mg/kg bw was found dead on Day 2.   Principal signs of reaction to treatment were piloerection and dyspnoea. Less common signs were hunched posture, ataxia, hypothermia and tonic convulsions. These signs developed immediately after dosing and lasted up to 4 hours post dosing.   All surviving rats achieved body weight gains during the first and second weeks of the study.   No macroscopic changes were noted at necropsy, except for pale lungs, red and thick fundus region of the stomach, gelatinous appearance of the mucosal surface of the fundus region of the stomach and small caecum which were noted in the animal dosed at 550 mg/kg bw that was killed in extremis 4 hours after dosing. These macrosocpic changes are commonly observed following the oral administration of an unpalatable or slightly irritant test article, with regurgitation and aspiration into pulmonary system and in isolated are considered not to associated with systemic toxicity.   Under the conditions of this study the rat acute oral LD50 was 175 mg/kg bw in female rats. Therefore, according to Annex I for Regulation (EC) 1272/2008 the test item must be classified in Category 3. The signal word ""Danger"" and hazard statement H301 ""Toxic if swallowed"" is required. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5c96e55-4b76-4a7c-9096-a539ee616619/documents/41ba44fc-d129-484f-91c4-8b2bb5f9db69_0f4110ee-77dc-42a9-8e61-5aaba3aad1b8.html,,,,,, 2-methyl-2H-isothiazol-3-one hydrochloride,26172-54-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5c96e55-4b76-4a7c-9096-a539ee616619/documents/41ba44fc-d129-484f-91c4-8b2bb5f9db69_0f4110ee-77dc-42a9-8e61-5aaba3aad1b8.html,,oral,LD50,175 mg/kg bw,adverse effect observed, 2-methyl-3-butenenitrile,16529-56-9,Oral: LD50 (males/rats): 232 mg/kg bw Dermal: LD50 (males/ rats): 482 mg/kg bwInhalation:LC50 (male rats/4h) : 9.95 mg/L ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61f55c0c-82a5-4ca1-9f4e-1ff40768bb42/documents/IUC5-6102ac7d-688f-4212-88b1-382ef3261991_f785a6e6-d46d-4170-9952-ef06139f83dc.html,,,,,, 2-methyl-3-butenenitrile,16529-56-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61f55c0c-82a5-4ca1-9f4e-1ff40768bb42/documents/IUC5-6102ac7d-688f-4212-88b1-382ef3261991_f785a6e6-d46d-4170-9952-ef06139f83dc.html,,oral,LD50,232 mg/kg bw,, 2-methyl-3-butenenitrile,16529-56-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61f55c0c-82a5-4ca1-9f4e-1ff40768bb42/documents/IUC5-6102ac7d-688f-4212-88b1-382ef3261991_f785a6e6-d46d-4170-9952-ef06139f83dc.html,,dermal,LD50,482 mg/kg bw,, 2-methyl-3-butenenitrile,16529-56-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61f55c0c-82a5-4ca1-9f4e-1ff40768bb42/documents/IUC5-6102ac7d-688f-4212-88b1-382ef3261991_f785a6e6-d46d-4170-9952-ef06139f83dc.html,,inhalation,LC50,"9,950 mg/m3",, "2-methyl-4-phenyl-1,3-dioxolane",33941-99-0," Oral (OECD 423), rat: LD50 > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff6c59ba-d89c-4f5f-b02d-688e748cb0c9/documents/621ab986-0c55-41b4-9dd6-c8130905ba2c_33f9d6d5-06ee-45d2-9e91-08f78382a641.html,,,,,, "2-methyl-4-phenyl-1,3-dioxolane",33941-99-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff6c59ba-d89c-4f5f-b02d-688e748cb0c9/documents/621ab986-0c55-41b4-9dd6-c8130905ba2c_33f9d6d5-06ee-45d2-9e91-08f78382a641.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2'-methylacetoacetanilide,93-68-5,"In the OECD SIDS key study mortality was oberserved at 1280 mg/kg dose level for males and at 1600 mg/kg for females, further deaths at 2000 mg/kg dose level for males and females. Therefore, the LD50 value by oral for rat is 1854 mg/kg for male and 1945 mg/kg for female. In the supporting study no animals died during the observation period.Therefore, the LD50 of test item AAOT is > 5000 mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/555e246f-43ef-4aff-9057-428a604fce3a/documents/IUC5-0e6a9d46-68fd-4b15-b9ee-878b189487a3_da902b51-50c5-4c49-9239-5ca24c5bfd3c.html,,,,,, 2'-methylacetoacetanilide,93-68-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/555e246f-43ef-4aff-9057-428a604fce3a/documents/IUC5-0e6a9d46-68fd-4b15-b9ee-878b189487a3_da902b51-50c5-4c49-9239-5ca24c5bfd3c.html,,oral,LD50,"1,854 mg/kg bw",adverse effect observed, 2-methylanisole,578-58-5," Acute oral toxicity LD50 was estimated to be 1363.40mg/kg bw, when male and female wistar rats were exposed with 1-methoxy-2-methylbenzene (578-58-5) orally. Acute dermal toxicity LD50 was estimated to be 3219 mg/kg bw.When male New Zealand White rabbits were exposed with 1-methoxy-2-methylbenzene (578-58-5) by dermal application. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c2915d6-a66b-4659-a367-1a0b645fa9e5/documents/ecec2da6-1c43-436e-8825-6b01f722cd89_07ed0426-548e-4578-8893-952b836210c4.html,,,,,, 2-methylanisole,578-58-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c2915d6-a66b-4659-a367-1a0b645fa9e5/documents/ecec2da6-1c43-436e-8825-6b01f722cd89_07ed0426-548e-4578-8893-952b836210c4.html,,oral,LD50,"1,363.4 mg/kg bw",no adverse effect observed, 2-methylanisole,578-58-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c2915d6-a66b-4659-a367-1a0b645fa9e5/documents/ecec2da6-1c43-436e-8825-6b01f722cd89_07ed0426-548e-4578-8893-952b836210c4.html,,dermal,LD50,"3,219 mg/kg bw",no adverse effect observed, 2-methylanthraquinone,84-54-8," Repeated dose toxicity: Oral The No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg/day for test substance  in male and female rats during subchronic repeated dose toxicity study. Repeated dose toxicity: inhalation  According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 2-methyl-9,10-anthraquinone ( 84-54-8), which is reported as 8.700716e-7mmHG.. Thus, exposure to inhalable dust, mist and vapour of the chemical 2-methyl-9,10-anthraquinone is highly unlikely. Therefore this study is considered for waiver.   Repeated dose toxicity: dermal The acute toxicity value for 2-methyl-9,10-anthraquinone ( 84-54-8) (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not irritating to skin. Also, given the use of the chemical as dye intermediate and used for all kinds of dye products; repeated exposure by the dermal route is unlikely. Thus, it is expected that 2-methyl-9,10-anthraquinone shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no dermal absorption data as well as no data available that suggests that 2-methyl-9,10-anthraquinone shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.   ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77663504-c99b-4fcc-b411-0146cc047bc1/documents/8f4d4562-ce37-45ce-9553-a3ee71742532_885bdab6-c92a-493f-a329-5eb33dc3765e.html,,,,,, 2-methylanthraquinone,84-54-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77663504-c99b-4fcc-b411-0146cc047bc1/documents/8f4d4562-ce37-45ce-9553-a3ee71742532_885bdab6-c92a-493f-a329-5eb33dc3765e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-methylanthraquinone,84-54-8," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.000116 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77663504-c99b-4fcc-b411-0146cc047bc1/documents/7880b1fe-2c9c-495d-bb07-0769eb878f57_885bdab6-c92a-493f-a329-5eb33dc3765e.html,,,,,, 2-methylanthraquinone,84-54-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77663504-c99b-4fcc-b411-0146cc047bc1/documents/7880b1fe-2c9c-495d-bb07-0769eb878f57_885bdab6-c92a-493f-a329-5eb33dc3765e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-methylanthraquinone,84-54-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77663504-c99b-4fcc-b411-0146cc047bc1/documents/7880b1fe-2c9c-495d-bb07-0769eb878f57_885bdab6-c92a-493f-a329-5eb33dc3765e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-methylbut-2-ene,513-35-9,The repeat dose toxicity of 2-methylbut-2-ene (2M2B) has been determined and this resulted in some general systemic effects in rats. These effects were slight and were most apparent in the high dose animals and only to a small extent in the mid-dose animals. The No Observed Effect Concentration was 1665 mg/m3 (580 ppm). ,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/26937e27-366f-46da-9e04-99a8fbd6934a/documents/IUC5-34727cb6-d9ea-4a3f-b390-93e6d9763572_a2bd41e2-fae8-457d-b68e-ba0720f0fbf0.html,,,,,, 2-methylbut-2-ene,513-35-9,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/26937e27-366f-46da-9e04-99a8fbd6934a/documents/IUC5-34727cb6-d9ea-4a3f-b390-93e6d9763572_a2bd41e2-fae8-457d-b68e-ba0720f0fbf0.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,665 mg/m3",,rat 2-methylbut-2-ene,513-35-9,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/26937e27-366f-46da-9e04-99a8fbd6934a/documents/IUC5-34727cb6-d9ea-4a3f-b390-93e6d9763572_a2bd41e2-fae8-457d-b68e-ba0720f0fbf0.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"5,740 mg/m3",adverse effect observed,rat 2-methylbut-2-ene,513-35-9,"Based on assessment of the available data for 2-methylbut-2-ene (2M2B), the oral LD50 is in the range of 1000 to 1700 mg/kg. The dermal LD50 is >2000 mg/kg. The 4-hour LC50 is >175,000 mg/m3. Inhalation of 2M2B can produce central nervous system depression, anaesthesia and/or asphyxiation that are reversible following cessation of exposures. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26937e27-366f-46da-9e04-99a8fbd6934a/documents/IUC5-a204ee81-2af6-48c5-bde6-d47aea0cb6ee_a2bd41e2-fae8-457d-b68e-ba0720f0fbf0.html,,,,,, 2-methylbut-2-ene,513-35-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26937e27-366f-46da-9e04-99a8fbd6934a/documents/IUC5-a204ee81-2af6-48c5-bde6-d47aea0cb6ee_a2bd41e2-fae8-457d-b68e-ba0720f0fbf0.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, 2-methylbut-2-ene,513-35-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26937e27-366f-46da-9e04-99a8fbd6934a/documents/IUC5-a204ee81-2af6-48c5-bde6-d47aea0cb6ee_a2bd41e2-fae8-457d-b68e-ba0720f0fbf0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-methylbut-2-ene,513-35-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26937e27-366f-46da-9e04-99a8fbd6934a/documents/IUC5-a204ee81-2af6-48c5-bde6-d47aea0cb6ee_a2bd41e2-fae8-457d-b68e-ba0720f0fbf0.html,,inhalation,LC50,"175,000 mg/m3",no adverse effect observed, 2-methylbut-3-yn-2-ol,115-19-5,Repeated dose toxicity:- oral: NOAEL = 45 mg/kg bw/day (male rat); NOAEL = 130 mg/kg bw (female rat) (90 d)- inhalation: NOAEC = 11 mg/m3 ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8feef30f-9036-4346-bf10-95be44d96029/documents/IUC5-59a3168e-dba3-4074-a4c1-6ef28c3af56f_6b29001e-791f-43a6-ae89-4d04356c9a57.html,,,,,, 2-methylbut-3-yn-2-ol,115-19-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8feef30f-9036-4346-bf10-95be44d96029/documents/IUC5-59a3168e-dba3-4074-a4c1-6ef28c3af56f_6b29001e-791f-43a6-ae89-4d04356c9a57.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,45 mg/kg bw/day,,rat 2-methylbut-3-yn-2-ol,115-19-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8feef30f-9036-4346-bf10-95be44d96029/documents/IUC5-59a3168e-dba3-4074-a4c1-6ef28c3af56f_6b29001e-791f-43a6-ae89-4d04356c9a57.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,11 mg/m3,,rat 2-methylbut-3-yn-2-ol,115-19-5,Acute toxicity:- oral: LD50 = 1420 mg/kg bw- inhalative: LC50 > 21.3 mg/l/4 h- dermal: LD0 = 172 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8feef30f-9036-4346-bf10-95be44d96029/documents/IUC5-185cd8fe-4ae6-4168-a4b5-d7897022e933_6b29001e-791f-43a6-ae89-4d04356c9a57.html,,,,,, 2-methylbut-3-yn-2-ol,115-19-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8feef30f-9036-4346-bf10-95be44d96029/documents/IUC5-185cd8fe-4ae6-4168-a4b5-d7897022e933_6b29001e-791f-43a6-ae89-4d04356c9a57.html,,oral,LD50,"1,420 mg/kg bw",, 2-methylbut-3-yn-2-ol,115-19-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8feef30f-9036-4346-bf10-95be44d96029/documents/IUC5-185cd8fe-4ae6-4168-a4b5-d7897022e933_6b29001e-791f-43a6-ae89-4d04356c9a57.html,,dermal,LD50,172 mg/kg bw,no adverse effect observed, 2-methylbut-3-yn-2-ol,115-19-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8feef30f-9036-4346-bf10-95be44d96029/documents/IUC5-185cd8fe-4ae6-4168-a4b5-d7897022e933_6b29001e-791f-43a6-ae89-4d04356c9a57.html,,inhalation,LC50,"21,300 mg/m3",, 2-methylbutan-2-ol,75-85-4," Based on the most reliable study (OECD 422, GLP compliant) the NOAEC for repeated dose toxicity was 2561 mg/m3, when rats were exposed by inhalation. The NOAEL for systemic repeated dose toxicity was 344 mg/kg bw/day , when rats were dermally exposed. The NOAEC for local repeated dose toxicity was 6663 mg/m3, when rats were exposed by inhalation. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4eeb0fa7-be41-4bb4-97a8-fa94d11fb3b0/documents/IUC5-5290b902-b6c2-48db-b07c-76f4b3728cfa_abdc635e-6bf6-4696-a2ca-0c3865852d41.html,,,,,, 2-methylbutan-2-ol,75-85-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4eeb0fa7-be41-4bb4-97a8-fa94d11fb3b0/documents/IUC5-5290b902-b6c2-48db-b07c-76f4b3728cfa_abdc635e-6bf6-4696-a2ca-0c3865852d41.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,344 mg/kg bw/day,, 2-methylbutan-2-ol,75-85-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4eeb0fa7-be41-4bb4-97a8-fa94d11fb3b0/documents/IUC5-5290b902-b6c2-48db-b07c-76f4b3728cfa_abdc635e-6bf6-4696-a2ca-0c3865852d41.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"2,561 mg/m3",,rat 2-methylbutan-2-ol,75-85-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4eeb0fa7-be41-4bb4-97a8-fa94d11fb3b0/documents/IUC5-5290b902-b6c2-48db-b07c-76f4b3728cfa_abdc635e-6bf6-4696-a2ca-0c3865852d41.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"6,663 mg/m3",no adverse effect observed,rat 2-methylbutan-2-ol,75-85-4,The acute oral LD50 value of 2-Methylbutan-2-ol derived from the key study in rats was 5184 mg/kg bw. The acute inhalation LC50 value in rats derived was between 20.6 mg/L and 10.8 mg/L. The acute dermal LD50 value of 2-Methylbutan-2-ol was 1720 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4eeb0fa7-be41-4bb4-97a8-fa94d11fb3b0/documents/IUC5-5783505f-93d7-4ce7-ad4a-84a2dc6d519e_abdc635e-6bf6-4696-a2ca-0c3865852d41.html,,,,,, 2-methylbutan-2-ol,75-85-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4eeb0fa7-be41-4bb4-97a8-fa94d11fb3b0/documents/IUC5-5783505f-93d7-4ce7-ad4a-84a2dc6d519e_abdc635e-6bf6-4696-a2ca-0c3865852d41.html,,oral,LD50,"5,184 mg/kg bw",adverse effect observed, 2-methylbutan-2-ol,75-85-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4eeb0fa7-be41-4bb4-97a8-fa94d11fb3b0/documents/IUC5-5783505f-93d7-4ce7-ad4a-84a2dc6d519e_abdc635e-6bf6-4696-a2ca-0c3865852d41.html,,dermal,LD50,"1,720 mg/kg bw",adverse effect observed, 2-methylbutan-2-ol,75-85-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4eeb0fa7-be41-4bb4-97a8-fa94d11fb3b0/documents/IUC5-5783505f-93d7-4ce7-ad4a-84a2dc6d519e_abdc635e-6bf6-4696-a2ca-0c3865852d41.html,,inhalation,discriminating conc.,20.6 mg/m3,adverse effect observed, 2-methylbutyl acrylate,44914-03-6,"Three Repeat Dose Studies have been conducted on the source chemical n-butyl acrylate. These results are considered to be appropriate for the target chemical 2-methylbutyl acrylate.13 Week Drinking Water Study in Rats: NOAEL Males: 84/mg/kg (Highest Dose Tested); NOAEL Females: 111mg/kg (Highest Dose Tested)13 Week Oral Gavage Study in Rats:LOAEL Male/Female: 150 mg/kg (Only dose tested; increased relative liver weights only)13 Week Inhalation Study in RatsNOAEC Systemic Effects: 108 ppm LOAEC: Systemic Effects (body weight decrease, clinical chemistry changes in females only): 211 ppmNOAEC Local: 21 ppmLOAEC: Local (histological changes in nasal mucosa): 108 ppm ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0af07a9-09f1-4e0b-bb92-a5f26c65f569/documents/IUC5-bda8396d-d2c1-4415-9aa2-cf2144970c0d_dade81e8-bcb3-485c-b2e8-c2606b951308.html,,,,,, 2-methylbutyl acrylate,44914-03-6,"LD50 (Acute Oral Rat): 3.5 ml/kg (3150 mg/kg)LC50 (Inhalation 4 hr Rat, Male and Female): 10.3 mg/l (1970 ppm)RD50 (Inhalation 30 minute Mouse Male): 1.78 mg/l (340 ppm)LD50 (Acute Dermal Rabbit): 2000 mg/kgLD50 (Acute Dermal Rabbit) 3024 mg/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0af07a9-09f1-4e0b-bb92-a5f26c65f569/documents/IUC5-331d708f-ee97-49c4-bb0b-47719b4e589d_dade81e8-bcb3-485c-b2e8-c2606b951308.html,,,,,, 2-methylcyclohexanone,583-60-8,"In order to predict the repeated dose toxicity for 2-methylcyclohexanone, a read across study was performed using the source substance as Cyclohexanone. It is concluded that a highly similarity exists between the target and the source compound since the identified structural difference, i.e. methyl group, is not expected to significantly impact the toxicity of the two chemicals. The mechanistic profile comparison leads to the conclusion that the target 2-methylcyclohexanone and the source cyclohexanone show very similar mechanistic profiles. The analysis highlights that the target 2-methylcyclohexanone and the source cyclohexanone show overall similar physicochemical profiles. The analysis of the reactivity properties highlights that the target 2-methylcyclohexanone and the source cyclohexanone show very similar reactivity profiles. The results for oral repeated-dose toxicity test of cyclohexanone exhibit qualitative and quantitative consistency. The combined oral NOEL in male and female rats of 508 mg/kg/day can be employed to estimate the repeated dose toxicity of the target compound - 2-methylcyclohexanone.Therefore, the study can be used for predicting repeated dose toxicity of the target 2-methylcyclohexanone. According to CLP Regulation (EU CLP, 2008), classification is not warranted since no significant toxic effects are expected at doses <100 mg/kg/day after repeated oral exposures.The prediction is associated with an overall low uncertainty coming from a similarity justification and high-tier complex endpoint (repeated dose toxicity). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9781f64-1362-42c3-ac4f-b505deeb034b/documents/087ed9c7-9ab0-4bbd-aa9e-6d14ecaa1b24_3992026b-7eb8-4614-896c-89122879dfb9.html,,,,,, 2-methylcyclohexanone,583-60-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9781f64-1362-42c3-ac4f-b505deeb034b/documents/087ed9c7-9ab0-4bbd-aa9e-6d14ecaa1b24_3992026b-7eb8-4614-896c-89122879dfb9.html,Chronic toxicity – systemic effects,oral,NOAEL,508 mg/kg bw/day,,rat 2-methylcyclohexanone,583-60-8,"The 2-methylcyclohexanone was screened for acute toxicity: oral, dermal and through inhalation (Smyth et al., 1969):• oral: 2-methylcyclohexanone LD50: =1370 - 2868 mg/kg bw • dermal: 2-methylcyclohexanone LD50: 1637 mg/kg bw • inhalation: 2-methylcyclohexanone LD50: 2800 ppm. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9781f64-1362-42c3-ac4f-b505deeb034b/documents/e9e70f33-e1f8-4238-8512-6c7ea3c70876_3992026b-7eb8-4614-896c-89122879dfb9.html,,,,,, 2-methylcyclohexanone,583-60-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9781f64-1362-42c3-ac4f-b505deeb034b/documents/e9e70f33-e1f8-4238-8512-6c7ea3c70876_3992026b-7eb8-4614-896c-89122879dfb9.html,,oral,LD50,"1,370 mg/kg bw",adverse effect observed, 2-methylcyclohexanone,583-60-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9781f64-1362-42c3-ac4f-b505deeb034b/documents/e9e70f33-e1f8-4238-8512-6c7ea3c70876_3992026b-7eb8-4614-896c-89122879dfb9.html,,dermal,LD50,"1,637 mg/kg bw",adverse effect observed, 2-methylcyclohexanone,583-60-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9781f64-1362-42c3-ac4f-b505deeb034b/documents/e9e70f33-e1f8-4238-8512-6c7ea3c70876_3992026b-7eb8-4614-896c-89122879dfb9.html,,inhalation,LC50,"2,800 ",adverse effect observed, 2-methylcyclohexyl acetate,5726-19-2," Key study: Test method similar to OECD 451. No GLP. Based on the read-across approach from experimental data on the analogue 2-isopropyl-5-methylcyclohexanol, the NOAEL for 2-methylcyclohexyl acetate when administered to rats for 103 consecutive weeks by oral route was determined to be 7498 ppm (~375 mg/kg bw/day) in males and females under test conditions. Key study: Test method similar to OECD 451. No GLP. Based on the read-across approach from experimental data on the analogue 2-isopropyl-5-methylcyclohexanol, the NOAEL for 2-methylcyclohexyl acetate when administered to mice for 103 consecutive weeks by oral route was determined to be 2000 ppm (~300 mg/kg bw/day) in females and 3999 ppm (~ 600 mg/kg bw/day) in males under test conditions. Supporting study: 13 week oral toxicity study. No GLP. Based on the read-across approach from experimental data on the analogue 2-isopropyl-5-methylcyclohexanol, the NOAEL for 2 -methylcyclohexyl acetate when administered to rats for 13 consecutive weeks by oral route was determined to be 7498 ppm (~750 mg/kg bw/day) in males and 14996 ppm (~ 1500 mg/kg bw/day) in females under test conditions Supporting study: 13 week oral toxicity study. No GLP. Based on the read-across approach from experimental data on the analogue 2-isopropyl-5-methylcyclohexanol,  the NOAEL for 2 -methylcyclohexyl acetate when administered to mice for 13 consecutive weeks by oral route was determined to be 3749 ppm (~563 mg/kg bw/day) in females and 14996 ppm (~ 2250 mg/kg bw/day) in males under test conditions. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c548622-4f2e-48a6-8b33-93243027f62b/documents/IUC5-52b26d8d-835c-4c99-b80c-36b6f2ffa922_d8ef87ba-844e-41b0-bba4-1779c7901b40.html,,,,,, 2-methylcyclohexyl acetate,5726-19-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c548622-4f2e-48a6-8b33-93243027f62b/documents/IUC5-52b26d8d-835c-4c99-b80c-36b6f2ffa922_d8ef87ba-844e-41b0-bba4-1779c7901b40.html,Chronic toxicity – systemic effects,oral,NOAEL,375 mg/kg bw/day,,rat 2-methylcyclohexyl acetate,5726-19-2,Acute toxicity: oral: Test method EEC B.1. GLP study. The acute oral LD50 for 2-methylcyclohexyl acetate was determined to be >2000 mg/kg bw in rats.Acute toxicity: inhalation: Test method EEC B.2. GLP study. The acute 4h-LD50 for 2-methylcyclohexyl acetate was determined to be >5.32 mg/L of air in rats.Acute toxicity: dermal: Test method EEC B.3. GLP study. The acute dermal LD50 for 2-methylcyclohexyl acetate was determined to be >2000 mg/kg bw in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c548622-4f2e-48a6-8b33-93243027f62b/documents/IUC5-a0ea5b68-9173-40cc-ae9e-eda35881dbf1_d8ef87ba-844e-41b0-bba4-1779c7901b40.html,,,,,, 2-methylcyclohexyl acetate,5726-19-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c548622-4f2e-48a6-8b33-93243027f62b/documents/IUC5-a0ea5b68-9173-40cc-ae9e-eda35881dbf1_d8ef87ba-844e-41b0-bba4-1779c7901b40.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-methylcyclohexyl acetate,5726-19-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c548622-4f2e-48a6-8b33-93243027f62b/documents/IUC5-a0ea5b68-9173-40cc-ae9e-eda35881dbf1_d8ef87ba-844e-41b0-bba4-1779c7901b40.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-methylcyclohexyl acetate,5726-19-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c548622-4f2e-48a6-8b33-93243027f62b/documents/IUC5-a0ea5b68-9173-40cc-ae9e-eda35881dbf1_d8ef87ba-844e-41b0-bba4-1779c7901b40.html,,inhalation,LC50,0.005 mg/m3,no adverse effect observed, "2-methylenepropane-1,3-diyl diacetate",3775-29-9,"Combined Repeated Dose and Reproductive/Developmental Toxicity Test of MPDAc by Oral Administration in Rats (OECD 422): MPDAc was repeatedly administered by oral gavage at 0 (control group), 12.5, 50, and 200 mg/kg from 14 days before mating through mating for 42 days in males, from 14 days before mating through gestation and parturition until Day 13 of lactation in females, and for 42 days without mating in satellite females to assess the repeated dose toxicity and reproductive and developmental toxicity. In addition, a 14-day recovery period was set for the control and 200 mg/kg groups and the reversibility of the toxicity effect was assessed.Deaths occurred in 4/12 test females treated with 200 mg/kg during the gestation period. Since the remaining test females treated with 200 mg/kg were considered at risk of deaths, the dose level and volume for the test females were reduced to 100 mg/kg and from 10 mL/kg to 5 mL/kg, respectively. Thereafter, since one more test female died during the lactation period, it was judged that no further administration was possible, and the administration was discontinued. Dose level for the test females is expressed as 200 (100) mg/kg. According to the results of this study, a No-Observed-Adverse-Effect Level (NOAEL) for repeated dose toxicity was estimated to be 12.5 mg/kg based on occurrence of moribundity and death, a decrease in body weight, an increase in food consumption, and injury to the liver, stomach, and duodenum at 50 or 200 (100) mg/kg. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e8ab46f-1ddc-41bc-9709-3362efa5144a/documents/8c3c6ed4-e337-4a7a-8940-0b27786be9cd_86082faf-ef34-44d0-bbcf-22b7d75b8e63.html,,,,,, "2-methylenepropane-1,3-diyl diacetate",3775-29-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e8ab46f-1ddc-41bc-9709-3362efa5144a/documents/8c3c6ed4-e337-4a7a-8940-0b27786be9cd_86082faf-ef34-44d0-bbcf-22b7d75b8e63.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,12.5 mg/kg bw/day,,rat "2-methylenepropane-1,3-diyl diacetate",3775-29-9,"Acute Oral Toxicity: The acute median lethal oral dose (LD50) to rats of 2-methylene-1-3-propanediol diacetate was demonstrated to be between 300 and 2000 mg/kg bodyweight. Acute Toxicity Inhalation: Based on the results that 1 female rat was found dead in this study, the median lethal concentration (LC50) was considered to be greater than 5.250 mg/L for rats when administered MPDAc by inhalation. According to the criteria for toxicity assessment list in Section 13, the acute inhalation toxicity of MPDAc was considered to be Category 5 of GHS (Globally Harmonized System of Classification and. Labelling of Chemicals), and the LC50 cut-off value was considered to be greater than 5~12.5 mg/L.   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e8ab46f-1ddc-41bc-9709-3362efa5144a/documents/861416f8-1ab1-495d-9d49-92d4d8fc024b_86082faf-ef34-44d0-bbcf-22b7d75b8e63.html,,,,,, "2-methylenepropane-1,3-diyl diacetate",3775-29-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e8ab46f-1ddc-41bc-9709-3362efa5144a/documents/861416f8-1ab1-495d-9d49-92d4d8fc024b_86082faf-ef34-44d0-bbcf-22b7d75b8e63.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "2-methylenepropane-1,3-diyl diacetate",3775-29-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e8ab46f-1ddc-41bc-9709-3362efa5144a/documents/861416f8-1ab1-495d-9d49-92d4d8fc024b_86082faf-ef34-44d0-bbcf-22b7d75b8e63.html,,inhalation,LC50,> 5.25 mg/L,no adverse effect observed, 2-methylglutaric acid,617-62-9,A 90 days oral repeated dose toxicity study (OECD408) on rat was performed.The highest dose was initially 1000 mg/kg bw/day and was lowered to 600 mg/kg bw/day because of strong local effects on the GI tract.No systemic effects were observed up to 600 mg/kg bw/day and the NOAEL was over 600 mg/kg bw/day. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6846e09-cd91-4f46-8182-110911eb47fa/documents/IUC5-1398a042-66c2-4688-b16a-fdec40382aa4_c0a9cd9f-eb53-4eb1-9bc6-1fed3369b9c6.html,,,,,, 2-methylglutaric acid,617-62-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6846e09-cd91-4f46-8182-110911eb47fa/documents/IUC5-1398a042-66c2-4688-b16a-fdec40382aa4_c0a9cd9f-eb53-4eb1-9bc6-1fed3369b9c6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat 2-methylglutaric acid,617-62-9,The LD50 by oral route was determined to be between 300 and 2000 mg/kg. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6846e09-cd91-4f46-8182-110911eb47fa/documents/IUC5-4fa32227-e911-443a-b4b9-91ce1e000ffa_c0a9cd9f-eb53-4eb1-9bc6-1fed3369b9c6.html,,,,,, 2-methylglutaric acid,617-62-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6846e09-cd91-4f46-8182-110911eb47fa/documents/IUC5-4fa32227-e911-443a-b4b9-91ce1e000ffa_c0a9cd9f-eb53-4eb1-9bc6-1fed3369b9c6.html,,oral,LD50,300 mg/kg bw,adverse effect observed, 2-methylglutaronitrile,4553-62-2,"Repeated dose toxicity by inhalation route: NOAEC is greater than 200 mg/m3.Decrease of the Body weight gain was observed at 200 mg/m3 compared to control groups. The Food consumption was not examined. Moreover, the body weight gain was normal again and similar to the control group during the recovery period. Therefore, this decrease of body weight gain can not be considered as an adverse effect.A increased of reticulocytes was also observed, however this reticulocyte increase was not relevant in the face of normal RBC mass and thus the changes in reticulocyte values were not considered to be adverse. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb6507ec-c258-4adc-8ff4-b920dbce909f/documents/IUC5-98fbb341-6aee-4690-ae16-063f654e0e12_a6b28884-8b0e-4fe0-b80d-66cf4aa6cd79.html,,,,,, 2-methylglutaronitrile,4553-62-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb6507ec-c258-4adc-8ff4-b920dbce909f/documents/IUC5-98fbb341-6aee-4690-ae16-063f654e0e12_a6b28884-8b0e-4fe0-b80d-66cf4aa6cd79.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,200 mg/m3,,rat 2-methylglutaronitrile,4553-62-2,"Oral: LD50 male (rats) is 170 mg/kg bw. Therefore, the product is considered as Toxic by oral route according to EU criteria.Dermal: LD50 male (rats) is 982 mg/kg bw. Therefore, the product is considered as Toxic by dermal route according to EU criteria.Inhalation: LC50/4h male (rats) is 0.66 mg/L. Therefore the product is considered as Toxic by inhalation route according to EU criteria. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb6507ec-c258-4adc-8ff4-b920dbce909f/documents/IUC5-f2074819-9d0f-427d-be1b-5e388cde6d3f_a6b28884-8b0e-4fe0-b80d-66cf4aa6cd79.html,,,,,, 2-methylglutaronitrile,4553-62-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb6507ec-c258-4adc-8ff4-b920dbce909f/documents/IUC5-f2074819-9d0f-427d-be1b-5e388cde6d3f_a6b28884-8b0e-4fe0-b80d-66cf4aa6cd79.html,,oral,LD50,170 mg/kg bw,, 2-methylglutaronitrile,4553-62-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb6507ec-c258-4adc-8ff4-b920dbce909f/documents/IUC5-f2074819-9d0f-427d-be1b-5e388cde6d3f_a6b28884-8b0e-4fe0-b80d-66cf4aa6cd79.html,,dermal,LD50,982 mg/kg bw,, 2-methylglutaronitrile,4553-62-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb6507ec-c258-4adc-8ff4-b920dbce909f/documents/IUC5-f2074819-9d0f-427d-be1b-5e388cde6d3f_a6b28884-8b0e-4fe0-b80d-66cf4aa6cd79.html,,inhalation,LC50,660 mg/m3,, 2-methylhydroquinone,95-71-6," The range of NOAEL for congeners of Methylhydroquinone in rodents (rats, mice) after oral administration is in the range of 20 – 402 mg/kg/d repeated oral doses considering the duration of experiments of 28d up to 2 years. The targeted toxicological endpoints are primarily decreased body weight and liver toxicity. Regarding the effects on the thyroid gland function, it appears that the OH-groups in para-position, like in methylhydroquinone, are inactive. Mild, transient tremors and reduced home-cage activity were also considered. Since the smallest experimental NOAEL obtained in animals are 20 mg/kg bw./ day, the experts set the NOAEL for the targeted substance Methylhydroquinone on 20 mg/kg bw./day. Nevertheless, it appears that a value of 50 mg/kg/day is also acceptable since the tremors obtained in the study of Topping, D.C. et al. 2007, are reversible and disappear during long term use. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29425fd6-19a6-4f63-96d5-78686298db58/documents/7ffc9f0b-7564-4cdd-85af-089cfc89a7f1_184b2332-be0c-4141-a207-254a002ad3f7.html,,,,,, 2-methylhydroquinone,95-71-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29425fd6-19a6-4f63-96d5-78686298db58/documents/7ffc9f0b-7564-4cdd-85af-089cfc89a7f1_184b2332-be0c-4141-a207-254a002ad3f7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 2-methylhydroquinone,95-71-6," In an Acute Toxic Class Method-test according to OECD test guideline 423 the LD50 (oral) of the test item, methylhydroquinone, for rats was determined to be >2000 mg/kg. Studies regarding the acute dermal toxicity and acute inhalative toxicity do not need to be conducted because the test item, methylhydroquinone, is classified as corrosive to the skin. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29425fd6-19a6-4f63-96d5-78686298db58/documents/3b8c351e-2c4c-480f-b7d4-3b546294913d_184b2332-be0c-4141-a207-254a002ad3f7.html,,,,,, 2-methylhydroquinone,95-71-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29425fd6-19a6-4f63-96d5-78686298db58/documents/3b8c351e-2c4c-480f-b7d4-3b546294913d_184b2332-be0c-4141-a207-254a002ad3f7.html,,oral,LD50,"2,001 mg/kg bw",adverse effect observed, "2-Methyloctane-1,8-diamine",148528-05-6,"2-Methyl-1,8-octanediamine (MODA) was tested in a subacute oral toxicity study with Sprague-Dawley rats according to the relevant Japanese Guidelines and in accordance with the principles of GLP. The no-observed-effect level (NOEL) for MODA wasdetermined to be 30 mg/kg/day under the conditions of the present study.Repeated exposure resulted in mortality at 150 mg/kg bw/d, this is sufficient evidence for classification as STOT-RE 2 (H373).Further testing is waived based on exposure considerations: waiving of sub-chronic repeated dose toxicity tests can be justified for MODA based on insignificant exposure as laid down in Annex XI section 3.2 (a). MODA is exclusively imported as polymer and no manufacturing or other handling of the monomer takes place in the EU. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24f2c6a2-57bf-4de7-ac5b-1be261600d55/documents/IUC5-f150fe8f-33c6-4ad3-857f-7a78ff59bb6b_1ba56818-49e9-4979-a10b-e77836390ca7.html,,,,,, "2-Methyloctane-1,8-diamine",148528-05-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24f2c6a2-57bf-4de7-ac5b-1be261600d55/documents/IUC5-f150fe8f-33c6-4ad3-857f-7a78ff59bb6b_1ba56818-49e9-4979-a10b-e77836390ca7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "2-Methyloctane-1,8-diamine",148528-05-6,The acute lethal oral dose (LD50) for MODA was determined to be between 500 and 1000 mg/kg bw. No fatalities occurred at the lower dose of 250 mg/kg bw. Inhalation and dermal studies were not conducted due to the corrosive properties of the substance. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24f2c6a2-57bf-4de7-ac5b-1be261600d55/documents/IUC5-afd5ea3d-599d-4899-b0bd-1017f6b58483_1ba56818-49e9-4979-a10b-e77836390ca7.html,,,,,, "2-Methyloctane-1,8-diamine",148528-05-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24f2c6a2-57bf-4de7-ac5b-1be261600d55/documents/IUC5-afd5ea3d-599d-4899-b0bd-1017f6b58483_1ba56818-49e9-4979-a10b-e77836390ca7.html,,oral,LD50,>=500 mg/kg bw,adverse effect observed, 2-methylpent-2-enal,623-36-9,Oral: The acute oral LD50 was determined to be 4290 mg/kg bw in rats. Dermal: The acute dermal LD50 was determined to be 4000 mg/kg bw in rabbits.Inhalation: The acute inhalation LC50 was determined to be 8100 mg/m³ air/4 h in rats. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b151585e-5a33-4e74-a6d5-972102fa0b42/documents/IUC5-175fbe5d-7b3e-41c5-8f16-3b573b8adc39_96b948fe-4c32-482a-ac5b-0f8559588277.html,,,,,, 2-methylpent-2-enal,623-36-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b151585e-5a33-4e74-a6d5-972102fa0b42/documents/IUC5-175fbe5d-7b3e-41c5-8f16-3b573b8adc39_96b948fe-4c32-482a-ac5b-0f8559588277.html,,oral,LD50,"4,290 mg/kg bw",, 2-methylpent-2-enal,623-36-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b151585e-5a33-4e74-a6d5-972102fa0b42/documents/IUC5-175fbe5d-7b3e-41c5-8f16-3b573b8adc39_96b948fe-4c32-482a-ac5b-0f8559588277.html,,dermal,LD50,"4,000 mg/kg bw",, 2-methylpent-2-enal,623-36-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b151585e-5a33-4e74-a6d5-972102fa0b42/documents/IUC5-175fbe5d-7b3e-41c5-8f16-3b573b8adc39_96b948fe-4c32-482a-ac5b-0f8559588277.html,,inhalation,LC50,"8,100 mg/m3",, 2-methylpentane,107-83-5,"Since no acute toxicity study was performed, the results of a 28-day oral toxicity study in rats with two dose groups (500 and 2000 mg/kg bw/d) of 2-Methylpentane have been used. The higher dose level is the limit dose normally applied in acute toxicty studies. The LD50 was greater than 2000 mg/kg bw/d, but 3 out of 10 animals died at this dose level in repeated dose testing. Also, 3/10 animals died at the lower dose level of 500 mg/kg bw/d. No mortality was observed in the negative control group. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b266212f-df4f-4451-b66f-9cbcdd519b58/documents/d68e6e6c-3556-49cf-9ce4-cb9bb83ca9d1_d1203996-ccbb-41a3-bc2e-4a3b84dadfed.html,,,,,, 2-methylpentane,107-83-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b266212f-df4f-4451-b66f-9cbcdd519b58/documents/d68e6e6c-3556-49cf-9ce4-cb9bb83ca9d1_d1203996-ccbb-41a3-bc2e-4a3b84dadfed.html,,oral,LD50,"> 2,000 mg/kg bw",adverse effect observed, "2-methylpentane-1,5-diamine",15520-10-2,"MPMD (DYTEK A amine) was applied to male and female Han Wistar rats via gavage (vehicle water, pH adjusted formulation) at doses of 0, 50, 150 or 500 mg/kg/day according to OECD TG 408 (daily exposure for 13 weeks). In view of the non-specific toxicity that occurred in males, the no-observed-adverse-effect level (NOAEL) in this oral gavage study was 50 mg/kg/day in males and 500 mg/kg/day in females. In a subacute inhalation toxicity study male rats were exposed for 6 hours per day and overall 10 times within two weeks to an aerosol/vapour mixture of MPMD. Concentrations used were 0, 9.2, 59 and 250 mg/m³ (analytical).  The effects observed in rats exposed to MPMD ranged from severe (including death) in the 250 mg/m³ group to minimal in the 9.2 mg/m³ group. Therefore, a LOAEC of 9.2 mg/m³ was established and classification with respect to specific target organ toxicity after short-term exposure is proposed: (STOT SE Cat 3, H335, together with Corr. Cat 1A). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): One reliable subacute study for the submission substance (Klimisch score = 2) is available. The quality of the database is good. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): One reliable OECD TG 408 study (Klimisch score = 1) is at hand. Further one reliable subacute screening study for the submission substance (Klimisch score = 1) is available. Overall the quality of the database is high. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7234629f-ca66-434d-8e85-2ccdecfbb833/documents/cba811e6-2499-495c-adad-bbebc0232d7f_06ae2ae0-dfb7-4e3e-b48c-deccbbefa6f0.html,,,,,, "2-methylpentane-1,5-diamine",15520-10-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7234629f-ca66-434d-8e85-2ccdecfbb833/documents/cba811e6-2499-495c-adad-bbebc0232d7f_06ae2ae0-dfb7-4e3e-b48c-deccbbefa6f0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "2-methylpentane-1,5-diamine",15520-10-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7234629f-ca66-434d-8e85-2ccdecfbb833/documents/cba811e6-2499-495c-adad-bbebc0232d7f_06ae2ae0-dfb7-4e3e-b48c-deccbbefa6f0.html,Repeated dose toxicity – local effects,inhalation,LOAEC,9.2 mg/m3,adverse effect observed,rat "2-methylpentane-1,5-diamine",15520-10-2,"OralIn a reliable study similar to OECD guideline 401 (Klimisch 2), MPMD was administered via oral gavage to 10 male CD rats per dose group. The LD50 value was calculated to be 1690 mg/kg bw. Clinical signs included salivation, lung noise, diarrhea and stained perineum. InhalationIn a reliable study (Klimisch 2) male and female rats were subjected to a 1 hour inhalation exposure to aerosol/vapour mixture with various MPMD concentrations. Clinical signs of toxicity could be found in all dose groups in different severity. Mortality was observed once during the exposure and more often within the 14 day observation period. Under the conditions of this test, the one-hour LC50 of the test material was 4.9 mg/L for male and female rats (95% CI 3.1 to 7.2 mg/L). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is reliable (Klimisch 2), similar to OECD TG 401 and therefore of good quality. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The study is reliable (Klimisch 2), similar to OECD TG 403 and therefore of good quality. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7234629f-ca66-434d-8e85-2ccdecfbb833/documents/e14b6f94-881a-4a93-84cb-6e1d79deca35_06ae2ae0-dfb7-4e3e-b48c-deccbbefa6f0.html,,,,,, "2-methylpentane-1,5-diamine",15520-10-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7234629f-ca66-434d-8e85-2ccdecfbb833/documents/e14b6f94-881a-4a93-84cb-6e1d79deca35_06ae2ae0-dfb7-4e3e-b48c-deccbbefa6f0.html,,oral,LD50,"1,690 mg/kg bw",adverse effect observed, "2-methylpentane-1,5-diamine",15520-10-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7234629f-ca66-434d-8e85-2ccdecfbb833/documents/e14b6f94-881a-4a93-84cb-6e1d79deca35_06ae2ae0-dfb7-4e3e-b48c-deccbbefa6f0.html,,inhalation,LC50,4.9 mg/L,adverse effect observed, 2-methylpentyl 2-hydroxybenzoate,98969-19-8," Oral (dietary): NOAEL (rat – systemic toxicity): Male: ≥ 3750 ppm (equivalent to ≥ 250 mg/kg bw/day), and/or Female: ≥ 3750 ppm (equivalent to ≥ 275 mg/kg bw/day), OECD TG 422, 2021 Oral: NOAEL (rat – reproductive toxicity): could not be established, OECD TG 422, 2021 Oral: NOAEL (rat – developmental toxicity): could not be established, OECD TG 422, 2021 Supporting information: Oral: NOAEL (rat – general toxicity and reproductive/developmental toxicity): Male: ≥ 3750 ppm (equivalent to ≥ 252 mg/kg bw/day), and/or Female: 3750 ppm (equivalent to ≥ 360 mg/kg bw/day), OECD TG 421, 2021 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19d70e35-093d-4ffb-a772-9f83de9ce52c/documents/54494a9e-be06-4a65-8f12-e24a745f3f15_79b1e4ff-fe13-4f5a-aa8a-9f796e94bdf4.html,,,,,, 2-methylpentyl 2-hydroxybenzoate,98969-19-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19d70e35-093d-4ffb-a772-9f83de9ce52c/documents/54494a9e-be06-4a65-8f12-e24a745f3f15_79b1e4ff-fe13-4f5a-aa8a-9f796e94bdf4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 2-methylpentyl 2-hydroxybenzoate,98969-19-8," Oral: LD50 > 2000 mg/kg bw and the LD50 cut-off was considered to be > 5000mg/kg bw female rat, OECD TG 420, 2020 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19d70e35-093d-4ffb-a772-9f83de9ce52c/documents/15a737cb-0a42-4dfe-8af8-f7bf1f5eef8d_79b1e4ff-fe13-4f5a-aa8a-9f796e94bdf4.html,,,,,, 2-methylpentyl 2-hydroxybenzoate,98969-19-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19d70e35-093d-4ffb-a772-9f83de9ce52c/documents/15a737cb-0a42-4dfe-8af8-f7bf1f5eef8d_79b1e4ff-fe13-4f5a-aa8a-9f796e94bdf4.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-methylprop-2-en-1-ol,513-42-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5149a13-fab1-4947-b3f1-3aa84fc15188/documents/181bacf2-e789-4dac-8075-9067e4501294_7fc772fe-6a71-4f7a-a041-4f8840dcba3d.html,,oral,LD50,500 mg/kg bw,, 2-methylprop-2-en-1-ol,513-42-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5149a13-fab1-4947-b3f1-3aa84fc15188/documents/181bacf2-e789-4dac-8075-9067e4501294_7fc772fe-6a71-4f7a-a041-4f8840dcba3d.html,,dermal,LD50,"> 2,000 mg/kg bw",, 2-methylpropane-2-thiol,75-66-1," Repeated dose toxicity of 2-methylpropane-2-thiol has been investigated in a 13-week inhalation toxicity study (Ulrich, 1984) and an oral combined repeated dose/reproductive/developmental toxicity study (MHLW, 2006) in rats. In the 3-month inhalation study, the NOAEC for systemic toxicity was 196 ppm (721 mg/m3). In the oral repeated-dose toxicity study (OECD TG 422), based on decreased body weight reduction in females at 200 mg/kg/day, the NOAEL was considered to be 50 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83790613-05dc-44ec-b1f0-c5b6936497f8/documents/IUC5-9db4773e-daf7-4fcf-8f27-65cc08f56cdb_1b53bc67-24ae-44af-aff9-5ba989fec780.html,,,,,, 2-methylpropane-2-thiol,75-66-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83790613-05dc-44ec-b1f0-c5b6936497f8/documents/IUC5-9db4773e-daf7-4fcf-8f27-65cc08f56cdb_1b53bc67-24ae-44af-aff9-5ba989fec780.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 2-methylpropane-2-thiol,75-66-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83790613-05dc-44ec-b1f0-c5b6936497f8/documents/IUC5-9db4773e-daf7-4fcf-8f27-65cc08f56cdb_1b53bc67-24ae-44af-aff9-5ba989fec780.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,721 mg/m3,,rat 2-methylpropane-2-thiol,75-66-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83790613-05dc-44ec-b1f0-c5b6936497f8/documents/IUC5-9db4773e-daf7-4fcf-8f27-65cc08f56cdb_1b53bc67-24ae-44af-aff9-5ba989fec780.html,Repeated dose toxicity – local effects,inhalation,NOAEC,367 mg/m3,adverse effect observed,rat 2-methylpropane-2-thiol,75-66-1," The acute inhalation study is the only acute toxicity study available for 2-methylpropane-2-thiol that has been conducted to a recognised test guideline and in compliance with GLP. However, studies that pre-date GLP and the OECD test guidelines are available for the oral and dermal routes. Oral LD50 (rat): 4729 mg/kg (Fairchild & Stokinger, 1958) Dermal LD50 (rat): > 2000 mg/kg (Latven, 1976) inhalation LC50 (rat, 4h, whole body): 94 622 mg/L (26 643 ppm) (Daly, 1986) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83790613-05dc-44ec-b1f0-c5b6936497f8/documents/IUC5-f02bbd26-972f-4d86-8495-717a33adf78e_1b53bc67-24ae-44af-aff9-5ba989fec780.html,,,,,, 2-methylpropane-2-thiol,75-66-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83790613-05dc-44ec-b1f0-c5b6936497f8/documents/IUC5-f02bbd26-972f-4d86-8495-717a33adf78e_1b53bc67-24ae-44af-aff9-5ba989fec780.html,,oral,LD50,"4,729 mg/kg bw",no adverse effect observed, 2-methylpropane-2-thiol,75-66-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83790613-05dc-44ec-b1f0-c5b6936497f8/documents/IUC5-f02bbd26-972f-4d86-8495-717a33adf78e_1b53bc67-24ae-44af-aff9-5ba989fec780.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-methylpropane-2-thiol,75-66-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83790613-05dc-44ec-b1f0-c5b6936497f8/documents/IUC5-f02bbd26-972f-4d86-8495-717a33adf78e_1b53bc67-24ae-44af-aff9-5ba989fec780.html,,inhalation,LC50,"94,622 mg/m3",, 2-methylpropene,115-11-7, Members of the butenes category are flammable gases at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. Members of the butenes category have low sub-chronic toxicity. Inhalation exposure is the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies of up to 2 years in rats or mice. Nasal lesions were observed in 2 year rodent studies at the highest concentration but are considered to be a non-adverse adaptation to chronic exposure to a hydrocarbon. Members of the butenes category are flammable gases at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. Members of the butenes category have low sub-chronic toxicity. Inhalation exposure is the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies of up to 2 years in rats or mice. Nasal lesions were observed in 2 year rodent studies at the highest concentration but are considered to be a non-adverse adaptation to chronic exposure to a hydrocarbon. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88ce2f3e-86e4-4a55-9512-ceaa9a6b1138/documents/6b665189-4f72-41a2-a8d5-6e3a12f6123f_c5531033-cd0b-455b-a3bc-5a4b3745fbfe.html,,,,,, 2-methylpropene,115-11-7,"Members of the butenes category are flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. Members of the butenes category have low acute inhalation toxicity. The LC50 for but-2 -ene is greater than 10,000 ppm (22,948 mg/m3). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88ce2f3e-86e4-4a55-9512-ceaa9a6b1138/documents/a952f1cf-a06d-4ef5-ac6e-1ab8b1756557_c5531033-cd0b-455b-a3bc-5a4b3745fbfe.html,,,,,, 2-methylpropyl-(R)-2-hydroxypropanoate,61597-96-4,"Based on a set of studies performed with either isobutyl (S)-lactate, being the optical antipode of isobutyl (R)-lactate, or on the primary metabolites isobutanol and lactate (test substance: calcium lactate), isobutyl (R)-lactate is considered to be devoid of any systemic toxicity up to the limit dose of 1000 mg/kg bw/day. However, local effects (irritation of nasal epithelium) were identified in the 28-day inhalation study on isobutyl (S)-lactate, resulting in an NOAEL of 200 mg/m³. Accordingly, isobutyl (R)-lactate is considered (by read-across) as irritating to the respiratory tract. For further information on the read-across approach, in line with the RAAF, please refer to IUCLID section 13.2. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b90c7d23-8834-4785-ae0c-f3fc228387e2/documents/IUC5-df542e7d-ddfe-442f-801e-69e5c11038f5_2282c627-93d6-44a4-aee6-1f1162e217af.html,,,,,, 2-methylpropyl-(R)-2-hydroxypropanoate,61597-96-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b90c7d23-8834-4785-ae0c-f3fc228387e2/documents/IUC5-df542e7d-ddfe-442f-801e-69e5c11038f5_2282c627-93d6-44a4-aee6-1f1162e217af.html,Repeated dose toxicity – local effects,inhalation,NOAEC,200 mg/m3,adverse effect observed,rat 2-methylpropyl-(R)-2-hydroxypropanoate,61597-96-4,Isobutyl (R)-lactate is not acutely toxic via any route of administration. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b90c7d23-8834-4785-ae0c-f3fc228387e2/documents/IUC5-675b8911-1d4b-4bc6-af89-2b14775c196a_2282c627-93d6-44a4-aee6-1f1162e217af.html,,,,,, 2-methylpyridine,109-06-8,"Repeated dose oral toxicity has been well studied for pyridine and 3-methylpyridine, representative members of a chemical category, and a reliable study exists for repeated dose inhalation toxicity for 3-methylpyridine. The oral toxicity studies are two year bioassay data in rats (F344 and Wistar) and mice (B6C3F1). NOAELs are established. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/794095da-bd5e-42b9-a74a-7274fd477146/documents/IUC5-7205f932-5ae8-49bd-8653-556ae33d41d9_e72daa1f-9f8c-4514-aad3-a7f5bd354f11.html,,,,,, 2-methylpyridine,109-06-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/794095da-bd5e-42b9-a74a-7274fd477146/documents/IUC5-7205f932-5ae8-49bd-8653-556ae33d41d9_e72daa1f-9f8c-4514-aad3-a7f5bd354f11.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,105 mg/m3",,rat 2-methylpyridine,109-06-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/794095da-bd5e-42b9-a74a-7274fd477146/documents/IUC5-7205f932-5ae8-49bd-8653-556ae33d41d9_e72daa1f-9f8c-4514-aad3-a7f5bd354f11.html,Chronic toxicity – systemic effects,oral,NOAEL,7 mg/kg bw/day,,rat 2-methylpyridine,109-06-8,"The substance shows mild to moderate acute toxicity by the oral, dermal and inhalation routes. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/794095da-bd5e-42b9-a74a-7274fd477146/documents/IUC5-c20260ae-359e-46b1-81f1-e5b52b3ba7f2_e72daa1f-9f8c-4514-aad3-a7f5bd354f11.html,,,,,, 2-methylpyridine,109-06-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/794095da-bd5e-42b9-a74a-7274fd477146/documents/IUC5-c20260ae-359e-46b1-81f1-e5b52b3ba7f2_e72daa1f-9f8c-4514-aad3-a7f5bd354f11.html,,oral,LD50,950 mg/kg bw,adverse effect observed, 2-methylpyridine,109-06-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/794095da-bd5e-42b9-a74a-7274fd477146/documents/IUC5-c20260ae-359e-46b1-81f1-e5b52b3ba7f2_e72daa1f-9f8c-4514-aad3-a7f5bd354f11.html,,dermal,LD50,316 mg/kg bw,adverse effect observed, 2-methylpyridine,109-06-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/794095da-bd5e-42b9-a74a-7274fd477146/documents/IUC5-c20260ae-359e-46b1-81f1-e5b52b3ba7f2_e72daa1f-9f8c-4514-aad3-a7f5bd354f11.html,,inhalation,LC50,"10,100 mg/m3",adverse effect observed, 2-methylquinoline,91-63-4,2-methylquinoline is of certain concern regarding acute toxicity. The oral LD50 rats is 1230 mg/kg/bw.The dermal LD50 rabbit is 1870 µL/kg equivalent to 1980 mg/kg. No data are available regarding acute toxicity of 2-methylquinoline for inhalation route. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50754a0f-033f-4fcb-b912-977b63d487e5/documents/IUC5-25ffc3ef-26fb-4c93-a767-856cbda3f1b5_aa635dc4-ada8-4adc-9ce4-17b5f4df5df6.html,,,,,, 2-methylquinoline,91-63-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50754a0f-033f-4fcb-b912-977b63d487e5/documents/IUC5-25ffc3ef-26fb-4c93-a767-856cbda3f1b5_aa635dc4-ada8-4adc-9ce4-17b5f4df5df6.html,,oral,LD50,"1,230 mg/kg bw",adverse effect observed, 2-methylquinoline,91-63-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50754a0f-033f-4fcb-b912-977b63d487e5/documents/IUC5-25ffc3ef-26fb-4c93-a767-856cbda3f1b5_aa635dc4-ada8-4adc-9ce4-17b5f4df5df6.html,,dermal,LD50,"1,980 mg/kg bw",adverse effect observed, 2-methylvaleraldehyde,123-15-9,"The LD50/LC50 values derived from the key-studies were: LD50 (oral, rat) > 5000 mg/kg bw and LC50 (rat, inhal.) > 8.4 g/m³. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e84d6b96-dd64-4f24-9c65-7ed4ae3ed85a/documents/IUC5-567813ce-ad3e-4c10-901c-462e0c595b00_70d3ebe3-64f5-4ef9-96be-2a276e068f9b.html,,,,,, 2-methylvaleraldehyde,123-15-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e84d6b96-dd64-4f24-9c65-7ed4ae3ed85a/documents/IUC5-567813ce-ad3e-4c10-901c-462e0c595b00_70d3ebe3-64f5-4ef9-96be-2a276e068f9b.html,,oral,LD50,"5,000 mg/kg bw",, 2-methylvaleraldehyde,123-15-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e84d6b96-dd64-4f24-9c65-7ed4ae3ed85a/documents/IUC5-567813ce-ad3e-4c10-901c-462e0c595b00_70d3ebe3-64f5-4ef9-96be-2a276e068f9b.html,,inhalation,LC50,"8,400 mg/m3",, 2-morpholinoethanesulphonic acid,4432-31-9, The systemic toxicity of the test substance was investigated in a experimental study according to OECD TG 422 under GLP-conditions. Based on the observation the NOAEL for systemic toxicity of male/female rats is 1000 mg/kg bw/day. The study was performed with the hydrate form of the substance (CAS 1266615-59-1). Taking into account a correction for the water content (7 %) the NOAEL for the anhydrous form (CAS 4432-31-9) is 930 mg/kg bw/day. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2f12e9d-9da1-4f73-b2d7-f9af8a76c500/documents/7270940b-f42b-4dd4-8749-b183e9736a80_dad393b0-bd9c-4db8-9aec-5aa51d50c5c9.html,,,,,, 2-morpholinoethanesulphonic acid,4432-31-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2f12e9d-9da1-4f73-b2d7-f9af8a76c500/documents/7270940b-f42b-4dd4-8749-b183e9736a80_dad393b0-bd9c-4db8-9aec-5aa51d50c5c9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,930 mg/kg bw/day,,rat 2-morpholinoethanesulphonic acid,4432-31-9," In a GLP-study according to OECD TG 423 (acute class method) with rats, the LD50 of the substance was determined as > 2000 mg/kg bw (reference 7.2.1 -1). The study was performed with the hydrate form of the substance (CAS 1266615-59-1). However, same results are expected for the anhydrous form (CAS 4432-31-9). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2f12e9d-9da1-4f73-b2d7-f9af8a76c500/documents/bbaee273-2124-4833-8b43-5112996f9801_dad393b0-bd9c-4db8-9aec-5aa51d50c5c9.html,,,,,, 2-morpholinoethanesulphonic acid,4432-31-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2f12e9d-9da1-4f73-b2d7-f9af8a76c500/documents/bbaee273-2124-4833-8b43-5112996f9801_dad393b0-bd9c-4db8-9aec-5aa51d50c5c9.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-morpholinoethanol,622-40-2,Oral: The acute oral LD50 was determined to be 5500 mg/kg bw in rats.Dermal: The acute dermal LD50 was determined to be 16000 mg/kg bw in rabbits.Inhalation: No mortalilty was detected when mice were exposed to a saturated atmosphere of the test substance for 8 hours. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a4eac1e-1c7f-4331-b5a2-a1e25714c0df/documents/IUC5-4a351209-1943-4aea-a051-c32540e344cc_1597f80e-d29b-4693-b71d-c3fb5065e6ff.html,,,,,, 2-morpholinoethanol,622-40-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a4eac1e-1c7f-4331-b5a2-a1e25714c0df/documents/IUC5-4a351209-1943-4aea-a051-c32540e344cc_1597f80e-d29b-4693-b71d-c3fb5065e6ff.html,,oral,LD50,"5,500 mg/kg bw",, 2-morpholinoethanol,622-40-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a4eac1e-1c7f-4331-b5a2-a1e25714c0df/documents/IUC5-4a351209-1943-4aea-a051-c32540e344cc_1597f80e-d29b-4693-b71d-c3fb5065e6ff.html,,dermal,LD50,"16,000 mg/kg bw",, "2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs.",92257-28-8," No Observed Adverse Effect Level (NOAEL) of 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar’ and ar’’-Me derivs (CAS No. 92257-28-8) in the Sprague Dawley rat via oral route, over a period of 28 days was found to be 1000 mg/kg body weight in male and female animals. Thus, comparing this effect with the criteria of CLP regulation, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar’ and ar’’-Me derivs (CAS No. 92257-28-8) can be not classified for repeated dose oral toxicity. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e97ed2a9-b57a-4a88-8480-8b7ebd97c778/documents/77deb1ad-43a4-4e10-935c-b4eb655fb9a6_8c925b4c-55e4-4281-8406-d55ba221f478.html,,,,,, "2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs.",92257-28-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e97ed2a9-b57a-4a88-8480-8b7ebd97c778/documents/77deb1ad-43a4-4e10-935c-b4eb655fb9a6_8c925b4c-55e4-4281-8406-d55ba221f478.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs.",92257-28-8," Acute oral toxicity: Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8). The studies are as mentioned below: 1. Acute oral toxicity study was conducted using test chemical in groups of 5 Carworth-Wistar male rats at the concentration range of 1880-3230 mg/kg bw. The test chemical was dissolved in suitable vehicle and administered via oral route. The dosages are arranged in a logarithmic series differing by a factor of two. Based upon mortalities during a 14-day observation period, the most probable LD50 value and its fiducial range are estimated by the method of Thompson using the Tables of Weil. The figures in parentheses show limits of ±1.96 standard deviations while the absence of parentheses indicates that no range is calculable because no dosage resulted in fractional mortality. 50% Mortality observed at 2410 mg/kg bw. Therefore, LD50 was considered to be 2410 mg/kg bw, wih 95% confidence limit of 1880-3230 mg/kg bw, when Carworth-Wistar male rats were treated with test chemical via oral route.  2. Acute oral toxicity study was conducted using test chemical in rats at the concentration of 2000 mg/kg bw. No Mortality observed at 2000 mg/kg bw. Therefore, LD50 was considered to be >2000 mg/kg bw, when rats were treated with test chemical via oral route. Thus, based on the above summarised studies, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) cannot be classified for acute oral toxicity. Hence, based on the data available for the structurally similar read across chemical, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs is not likely to be toxic in the dose range of >2000 – 2410 mg/Kg bw.   Acute Inhalation toxicity:  2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) has very low vapour pressure (1.49E-10 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal Toxicity: Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute dermal toxicity of the test chemical 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8). The studies are as mentioned below: 1. The acute dermal toxicity study was designed and conducted for test chemical in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was found to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that test chemical does not classify as an acute dermal toxicant. CLP Classification: “Not classified”.  2. Acute Dermal toxicity study was conducted using test chemical in groups of 4 albino New Zealand male rabbits at the concentration range of 2700-18500 mg/kg bw. The fur is removed from the entire trunk by clipping, and the dose is retained beneath an impervious plastic film. Dosages greater than 20 ml/kg cannot be retained in contact with the skin. The animals are immobilized during the 24-hour contact period, after which the film is removed and the rabbits are caged for the subsequent 14-day observation period. The LD50 is calculated as described by a technique closely akin to the one-day cuff method of Draize and associates. 50% Mortality observed at 7100 mg/kg bw. Therefore, LD50 was considered to be 7100 mg/kg bw, wih 95% confidence limit of 2700-18500 mg/kg bw, when groups of 4 albino New Zealand male rabbits were treated with test chemical by dermal application occlusively. Thus, based on the above summarised studies, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs (CAS no.: 92257-28-8) cannot be classified for acute dermal toxicity. Hence, based on the data available for the structurally similar read across chemical, 2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo) phenyl]azo]-, ar' and ar''-Me derivs is not likely to be toxic in the dose range of >2000 – 7100 mg/Kg bw for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e97ed2a9-b57a-4a88-8480-8b7ebd97c778/documents/ab64f4e8-4f61-47ab-9244-fe0e3d718812_8c925b4c-55e4-4281-8406-d55ba221f478.html,,,,,, "2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs.",92257-28-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e97ed2a9-b57a-4a88-8480-8b7ebd97c778/documents/ab64f4e8-4f61-47ab-9244-fe0e3d718812_8c925b4c-55e4-4281-8406-d55ba221f478.html,,oral,LD50,"2,410 mg/kg bw",no adverse effect observed, "2-Naphthalenamine, N-(2-ethylhexyl)-1-[[4-(phenylazo)phenyl]azo]-, ar' and ar''-Me derivs.",92257-28-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e97ed2a9-b57a-4a88-8480-8b7ebd97c778/documents/ab64f4e8-4f61-47ab-9244-fe0e3d718812_8c925b4c-55e4-4281-8406-d55ba221f478.html,,dermal,LD50,"7,100 mg/kg bw",no adverse effect observed, "2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3,8-bis[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, trisodium salt",607724-47-0," The purpose of the study was to evaluate the potential toxic effect of the test item Blendazol Red Blendwell when administered as a single oral dose to Wistar rats. The procedure according to OECD Guideline 423 Acute Toxic Class(ATC)method was used.  Alimit dose of 2000 mg/kg body weight was used as a starting dose.One group of 3 females was dosed. Test item-related mortality was not observed during 24 hours and therefore in a next steps 3 females were treated with the same dose.All 6 females survived the limit dose. The limit dose of 2000 mg/kg did not cause death, evident signs of toxicity or body weight loss during the 14-day long observation period.During necropsy, no macroscopic findings were observed. The LD50of the test item Blendazol Red Blendwell is greater than 2000 mg/kg body weight after single oral administration to Wistar rats. Based on Annex 2d Test Procedure with a Starting Dose of 2000 mg/kg body weight of OECD Guideline 423 it can be concluded that thetest item Blendazol Red Blendwell is classified in Category 5/Unclassified with a LD50 cutoff value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd847b8c-2b8a-48d9-9651-4582960444ac/documents/d14aed15-3f5d-4485-b3f9-e5d4a2d31657_95477bd8-acfd-4ad8-8ae0-5aa6ed6d819e.html,,,,,, "2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3,8-bis[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, trisodium salt",607724-47-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd847b8c-2b8a-48d9-9651-4582960444ac/documents/d14aed15-3f5d-4485-b3f9-e5d4a2d31657_95477bd8-acfd-4ad8-8ae0-5aa6ed6d819e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium salt ",503155-49-5," Repeated dose toxicity: Oral The No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg/day, when rodents were treated with the given test chemical during repeated dose toxicity study.   Repeated dose toxicity: Inhalation A short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the given test chemical has very low vapor pressure 6.79E-42 mm Hg, so the potential for the generation of inhalable vapors is very low. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated inhalation toxicity was considered for waiver.   Repeated dose toxicity: Dermal A short-term toxicity study does not need to be conducted because exposure of humans via dermal in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the acute dermal toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c3a325f-fd4e-446a-b694-e873ba737cb4/documents/b824cec3-fbbd-4fc0-b7b7-4fbfd3d8b2dd_6076fb6c-0e18-4a55-8d61-0b18baec7773.html,,,,,, "2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium salt ",503155-49-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c3a325f-fd4e-446a-b694-e873ba737cb4/documents/b824cec3-fbbd-4fc0-b7b7-4fbfd3d8b2dd_6076fb6c-0e18-4a55-8d61-0b18baec7773.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium salt ",503155-49-5," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The studies concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 6.79E-42 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c3a325f-fd4e-446a-b694-e873ba737cb4/documents/d1e4613d-023b-424e-8e77-8b8e1b2fd113_6076fb6c-0e18-4a55-8d61-0b18baec7773.html,,,,,, "2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium salt ",503155-49-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c3a325f-fd4e-446a-b694-e873ba737cb4/documents/d1e4613d-023b-424e-8e77-8b8e1b2fd113_6076fb6c-0e18-4a55-8d61-0b18baec7773.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[[2-methoxy-5-methyl-4-[[2-(sulfooxy)ethyl]sulfonyl] phenyl]azo]-8-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-, tetrasodium salt ",503155-49-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c3a325f-fd4e-446a-b694-e873ba737cb4/documents/d1e4613d-023b-424e-8e77-8b8e1b2fd113_6076fb6c-0e18-4a55-8d61-0b18baec7773.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4)",607724-37-8," Repeated dose toxicity: Oral The no observed adverse effect level (NOAEL) for 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl] diazenyl]-8-[2-[2-sulfo-4-[ [2-(sulfooxy) ethyl] sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (CAS no.: 607724-37-8) is considered to be 1300 mg/kg/day. Hence the test chemical is not likely to be toxic as per the criteria mentioned in CLP regulation. Repeated dose toxicity: Inhalation 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl] diazenyl]-8-[2-[2-sulfo-4-[ [2-(sulfooxy) ethyl] sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (CAS no.: 607724-37-8) has very low vapour pressure (3.8797E-17 Pa. = 2.91E-19 mmHg). Also the particle size distribution was determined to be in the range of 147 micron to 52 micron. So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the end point for repeated dose toxicity by inhalation route was considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value for 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl] diazenyl]-8-[2-[2-sulfo-4-[ [2-(sulfooxy) ethyl] sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (CAS no.: 607724-37-8) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a520333a-7896-4fde-af44-3fcd7830679f/documents/9a19216b-1ddc-4418-9d57-91338be53da8_2df3b8da-f9d6-468d-acb0-3ae7f4ace0e0.html,,,,,, "2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4)",607724-37-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a520333a-7896-4fde-af44-3fcd7830679f/documents/9a19216b-1ddc-4418-9d57-91338be53da8_2df3b8da-f9d6-468d-acb0-3ae7f4ace0e0.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,300 mg/kg bw/day",,mouse "2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4)",607724-37-8," Acute oral Toxicity:  The acute oral toxicity dose (LD50) for 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (607724-37-8) was based on data available for the structurally similar read across chemicals. The LD50 value is between 300-2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (607724-37-8) cannot be classified for acute oral toxicity.  Acute Inhalation Toxicity:  2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (CAS no.: 607724-37-8) has very low vapour pressure (3.8797E-17 Pa. = 2.91E-19 mmHg),So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver. Acute dermal Toxicity:  The acute dermal toxicity dose (LD50) for 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (607724-37-8) was based on data available for the structurally similar read across chemicals. The LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4) (607724-37-8)cannot be classified for acute dermal toxicity.  ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a520333a-7896-4fde-af44-3fcd7830679f/documents/6c59e24a-759f-4c7b-a2fc-230d6a36ab2e_2df3b8da-f9d6-468d-acb0-3ae7f4ace0e0.html,,,,,, "2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4)",607724-37-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a520333a-7896-4fde-af44-3fcd7830679f/documents/6c59e24a-759f-4c7b-a2fc-230d6a36ab2e_2df3b8da-f9d6-468d-acb0-3ae7f4ace0e0.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-3-[2-[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-8-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:4)",607724-37-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a520333a-7896-4fde-af44-3fcd7830679f/documents/6c59e24a-759f-4c7b-a2fc-230d6a36ab2e_2df3b8da-f9d6-468d-acb0-3ae7f4ace0e0.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated",85203-90-3," Repeated dose toxicity: Oral: Repeated dose oral toxicity study was predicted for the target chemical 2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl) azo] phenyl] azo]-, ar-styrenated on the basis of the data from the read across chemicals. Based on the data available for the read across chemicals, 2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl) azo] phenyl] azo]-, ar-styrenated is likely to be safe atleast in the dose of 2829 mg/Kg/day and hence the test chemical is considered to be non toxic as per the criteria mentioned in CLP regulation. Repeated dose toxicity: Inhalation 2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated has very low  vapor pressure (2.0265E-17 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated inhalation toxicity was considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value for 2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated (as provided in section 7.2.3) based on the ddata available from the read across chemicals is >2000 mg/kg body weight. The substance was also considered to be not irritating and not sensitizing to the skin on the basis of read across data. Based on these considerations, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/221d0b72-2a01-401b-9bca-c95a27caf47d/documents/595dc1bc-8130-4bfb-b0a2-0f0216322b9f_88267ca9-00ee-43b4-98fd-b9a5010e348f.html,,,,,, "2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated",85203-90-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/221d0b72-2a01-401b-9bca-c95a27caf47d/documents/595dc1bc-8130-4bfb-b0a2-0f0216322b9f_88267ca9-00ee-43b4-98fd-b9a5010e348f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,829 mg/kg bw/day",,rat "2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated",85203-90-3," Acute oral toxicity: Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical 2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl) azo] phenyl] azo]-, ar-styrenated(85203-90-3).The studies are as mentioned below: 1.Acute oral toxicity study of test chemical was conducted in 40 Crj: CD (SD) IGS, SPF male and female rat at the concentration of 0, 500, 1000 and 2000 mg/kg bw. The test substance (Purity - >99 %; Obtained from - Dainippon Ink & Chemicals, Inc. and lot number - 000207) was suspended in a medium containing 0.1% Tween 80 added 0.5% CMC-Na aqueous solution as 20 mL/kg. Mortality and general condition were observed over 4 days, 30 minutes, 1, 3 and 6 hours after administration, once a day for 14 days, thereafter. Body weight was measured using an epple dish balance on days 4, 8 and 15 immediately before administration.Animals were observed for clinical signs. No death occurred in both males and females.Clinical signs observed such as, red feces exhibiting the same color tone as the test substance were found between 6 hours and 3 days after administration in males and females of the test substance - administered group, and in all the sexes on the 2nd day. In addition, the coloration of the coat considered to originate from this red flavor was observed in males and females of the test substance-administered group between the 2nd and 4th days. But no abnormality considered to be a toxicity change was observed. No abnormality was found in body weight of animals. Diaphragmatic hernia in the thoracic cavity was found in one female in the 1000 mg/kg group. In the hernia, the caudate portion of the liver protruded nodularly into the thoracic cavity, a part of which was adhered to the chest wall. Since this change was expressed only in one case and not related to the dose, it was judged as a contingent finding. No other abnormality was found. Therefore,LD50 was considered to be >2000 mg/kg bw, when Male and female SD rats were treated with test chemical via oral route. 2.Acute oral toxicity study was done infemale Sprague Dawley rats using test chemical.Distilled water was used as vehicle.Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg resulted in diarrhoea (black colour stools) in all animals with onset at 2 hours and no mortality after the dosing. As no mortality were observed at 24 hours after the dosing, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg resulted in diarrhoea (black colour stools) in all animals with onset at 4 hours and no mortality after the dosing. All animals from 300 mg/kg and 2000 mg/kg dose groups survived through the study period of 14 days. Staining of the stool is attributed to the black colour of the test item. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups.Hence,LD50 value was considered to be5000 mg/kg bw,when female Sprague Dawleyrats were treated with test chemical orally via gavage following 14 days of observation period according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method). 3.In acute oral toxicity study, mice were treated with test chemical orally. 50 % Mortality was observed in treated mice at 20,000 mg/kg bw. Therefore, LD50 was considered to be 20,000 mg/kg bw. When mice were treated with test chemical orally. Thus, based on the above summarised studies,2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl) azo] phenyl] azo]-, ar-styrenated(85203-90-3)and it’s structurallyand functionally similarread across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl) azo] phenyl] azo]-, ar-styrenated(85203-90-3)cannot be classified for acute oral toxicity.Hence,based on the data available for the structurally and functionally similar read across, test chemical 2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl) azo] phenyl] azo]-, ar-styrenated(85203-90-3) is not likely to be toxic atleast at the dose of >2000 mg/Kg bw. Acute inhalation toxicity: 2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated has very low  vapor pressure (2.0265E-17 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated inhalation toxicity was considered for waiver. Acute dermal toxicity: Data available for the structurally and functionally similar read across chemicals has been reviewed to determine theAcute dermal toxicityof the test chemical 2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl) azo] phenyl] azo]-, ar-styrenated(85203-90-3).The studies are as mentioned below: 1.In acute dermal toxicity study,male and female Sprague Dawley rats were treated with test chemical in the concentration of 2000 mg/kg bw by dermal application.Distilled water was used as vehicle. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment.Hence,The LD50 value was considered to be >2000 mg/kg bw,when male and female Sprague Dawley rats were semiocclusively treated with test chemical by dermal application following 14 days of observation period according to OECD Guideline 402 (Acute Dermal Toxicity). 2.In an acute dermal toxicity study, Wistar male and female rats were treated with test chemical in the concentration of 2000 mg/kg bw by dermal application. No mortality and any clinical sign of toxicity were observed throughout the observation period of 14 days in treated rats. The body weight of each animal recorded on day 0, 7th and 14th showed normal increase and there was no significant increase or decrease in weight was recorded. Therefore, LD50 was considered to be > 2000 mg/kg bw,when Wistar male and female rats were treated with 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs by dermal application. 3.In acute dermal toxicity study,rabbits were treated with test chemical in the concentration of 10000 mg/kg bw by dermal application.No mortality was observed in treated rabbits at dose 10000 mg/kg bw.Therefore, LD50 value was considered to be >10000 mg/kg bw,when rabbits were treated with test chemical  by dermal application. Thus, based on the above summarised studies,2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl) azo] phenyl] azo]-, ar-styrenated(85203-90-3)and it’s structurally and functionally similar read across substances, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl) azo] phenyl] azo]-, ar-styrenated(85203-90-3)cannot be classified for acute dermal toxicity.Hence,based on the data available for the structurally and functionally similar read across chemical, 2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl) azo] phenyl] azo]-, ar-styrenated(85203-90-3) is not likely to be toxic atleast at the dose of >10000 mg/Kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/221d0b72-2a01-401b-9bca-c95a27caf47d/documents/76942c12-d473-4493-9afe-be343e3de3c6_88267ca9-00ee-43b4-98fd-b9a5010e348f.html,,,,,, "2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated",85203-90-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/221d0b72-2a01-401b-9bca-c95a27caf47d/documents/76942c12-d473-4493-9afe-be343e3de3c6_88267ca9-00ee-43b4-98fd-b9a5010e348f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Naphthalenol, 1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]-, ar-styrenated",85203-90-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/221d0b72-2a01-401b-9bca-c95a27caf47d/documents/76942c12-d473-4493-9afe-be343e3de3c6_88267ca9-00ee-43b4-98fd-b9a5010e348f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs.",70879-65-1,"The substance 2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs. does not exhibit repeated dose toxicity via oral,inhalation or dermal route. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/96e73681-7681-4c40-a427-5ad98848041c/documents/IUC5-7c6a9226-89bb-41ea-a347-9850a8d9696a_528475d1-69a7-4428-bd11-bf4fd12cb38e.html,,,,,, "2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs.",70879-65-1,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/96e73681-7681-4c40-a427-5ad98848041c/documents/IUC5-7c6a9226-89bb-41ea-a347-9850a8d9696a_528475d1-69a7-4428-bd11-bf4fd12cb38e.html,Sub-chronic toxicity – systemic effects,oral,,120.165 mg/kg bw/day,,rat "2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs.",70879-65-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): K1 level data Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): K1 level data ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96e73681-7681-4c40-a427-5ad98848041c/documents/IUC5-5fd58b51-c3c1-49b0-a344-1bece2140f5e_528475d1-69a7-4428-bd11-bf4fd12cb38e.html,,,,,, "2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs.",70879-65-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96e73681-7681-4c40-a427-5ad98848041c/documents/IUC5-5fd58b51-c3c1-49b0-a344-1bece2140f5e_528475d1-69a7-4428-bd11-bf4fd12cb38e.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, "2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar',ar''-Me derivs.",70879-65-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96e73681-7681-4c40-a427-5ad98848041c/documents/IUC5-5fd58b51-c3c1-49b0-a344-1bece2140f5e_528475d1-69a7-4428-bd11-bf4fd12cb38e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar-heptyl ar',ar''-Me derivs.",92257-31-3," Only reliable data via the oral route are available Key study: OECD 422 in rats Supporting studies: 14 day range finding study (in rats); 4 week repeated dose toxicity study in rats with 2 week recovery (top dose group only) Disregarded studies: OECD 422 in rats - disregarded due to apparent errors in dosing throughout the study A dermal carcinogenicity study is available, however it was performed by Industrial Biotest who were extensivly investigated for scientific fraud. Consequently this study is disregarded. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a962dc3-a73b-4f2a-9e3e-07002651567d/documents/c74dc5b5-f09f-4a13-9531-7d98ad717dfa_09fd5d83-5f31-456a-9164-0707e2fe8165.html,,,,,, "2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar-heptyl ar',ar''-Me derivs.",92257-31-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a962dc3-a73b-4f2a-9e3e-07002651567d/documents/c74dc5b5-f09f-4a13-9531-7d98ad717dfa_09fd5d83-5f31-456a-9164-0707e2fe8165.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,2 mg/kg bw/day,,rat "2-Naphthalenol, 1-[[4-(phenylazo)phenyl]azo]-, ar-heptyl ar',ar''-Me derivs.",92257-31-3,One acute oral toxicity study of high reliability. one acute oral and one acute dermal toxicity study of low reliability. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a962dc3-a73b-4f2a-9e3e-07002651567d/documents/IUC5-b6774e7f-9095-4223-8e99-dd285b9d91c4_09fd5d83-5f31-456a-9164-0707e2fe8165.html,,,,,, 2-nitroaniline,88-74-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/066382c0-3269-4861-a4e7-1781a4621f80/documents/IUC5-c8617b84-3764-4311-beed-0b9e0811de79_228989d3-10ab-489f-b5ef-8b70ac2eafcd.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,10 mg/m3,,rat 2-nitroaniline,88-74-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/066382c0-3269-4861-a4e7-1781a4621f80/documents/IUC5-c8617b84-3764-4311-beed-0b9e0811de79_228989d3-10ab-489f-b5ef-8b70ac2eafcd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 2-nitro-p-toluidine,89-62-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The Kemi database is considered to be a reliable database. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/240998db-3196-486d-a48a-35a6eb82736b/documents/IUC5-f4831cd3-88c5-47ca-afb4-cfe152625af9_0d23f0a8-075b-44a1-9565-3ebea30a18f4.html,,,,,, 2-nitro-p-toluidine,89-62-3,"From the available results; the chemical 2-nitro-p-toluidine, is expected to exhibit acute toxic effects in the category 4 (based upon the LD50 and LC50 values mentioned in the CLP regulation) by the oral, inhalation and dermal route. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/240998db-3196-486d-a48a-35a6eb82736b/documents/IUC5-f5b39d51-48a1-4c86-9367-9058a9235216_0d23f0a8-075b-44a1-9565-3ebea30a18f4.html,,,,,, 2-nitro-p-toluidine,89-62-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/240998db-3196-486d-a48a-35a6eb82736b/documents/IUC5-f5b39d51-48a1-4c86-9367-9058a9235216_0d23f0a8-075b-44a1-9565-3ebea30a18f4.html,,oral,LD50,590.944 mg/kg bw,adverse effect observed, 2-nitro-p-toluidine,89-62-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/240998db-3196-486d-a48a-35a6eb82736b/documents/IUC5-f5b39d51-48a1-4c86-9367-9058a9235216_0d23f0a8-075b-44a1-9565-3ebea30a18f4.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, 2-nitro-p-toluidine,89-62-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/240998db-3196-486d-a48a-35a6eb82736b/documents/IUC5-f5b39d51-48a1-4c86-9367-9058a9235216_0d23f0a8-075b-44a1-9565-3ebea30a18f4.html,,inhalation,LC50,19.316 ,adverse effect observed, 2-nitro-p-xylene,89-58-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51aa7f43-c5b7-4295-8b5d-cdb609aa1944/documents/IUC5-6e7859fe-3cb9-472b-be30-ad165a7bf374_37e81ec1-1dba-4be4-9230-d7045f2f4ac7.html,,oral,LD50,"2,440 mg/kg bw",, "2-octadecyl-1H-thioxantheno[2,1,9-def]isoquinoline-1,3(2H)-dione",27870-92-4,"1h-thioxantheno[2,1,9-def]isoquinoline-1,3(2h)-dione, 2-octadecyl- is non toxic by oral and dermal route. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f294dc39-364b-497c-b2ee-7d6e130d7aa7/documents/IUC5-e84842fc-a629-42c8-b391-c188234c5e8b_8cb83db0-8698-4603-982e-28b6d6edb896.html,,,,,, "2-octadecyl-1H-thioxantheno[2,1,9-def]isoquinoline-1,3(2H)-dione",27870-92-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f294dc39-364b-497c-b2ee-7d6e130d7aa7/documents/IUC5-e84842fc-a629-42c8-b391-c188234c5e8b_8cb83db0-8698-4603-982e-28b6d6edb896.html,,oral,LD50,"5,931.255 mg/kg bw",no adverse effect observed, "2-octadecyl-1H-thioxantheno[2,1,9-def]isoquinoline-1,3(2H)-dione",27870-92-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f294dc39-364b-497c-b2ee-7d6e130d7aa7/documents/IUC5-e84842fc-a629-42c8-b391-c188234c5e8b_8cb83db0-8698-4603-982e-28b6d6edb896.html,,dermal,LD50,"4,632.438 mg/kg bw",no adverse effect observed, "3-(oct-2-en-1-yl)dihydrofuran-2,5-dione",42482-06-4,"Repeated dose toxicity effects were observed at 150 mg/kg bw/day after 28-days of oral exposure to a chemical category member, tripropenyl succinic anhydride (TSA). The NOAEL is 50 mg/kg bw/d. The WHO reviewed the human health risks of cyclic acid anhydrides, and, while data are limited, did not find a weight of evidence which suggests that repeated dose toxicity represents a health risk. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/502727e0-07b6-4e49-8fe9-27aab796d0a1/documents/IUC5-41a3f3c1-05dd-4a29-9180-268751e86455_ce8580fe-252c-4728-8926-c75f9793477f.html,,,,,, "3-(oct-2-en-1-yl)dihydrofuran-2,5-dione",42482-06-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/502727e0-07b6-4e49-8fe9-27aab796d0a1/documents/IUC5-41a3f3c1-05dd-4a29-9180-268751e86455_ce8580fe-252c-4728-8926-c75f9793477f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "3-(oct-2-en-1-yl)dihydrofuran-2,5-dione",42482-06-4,"The substance was tested in rats using OECD guideline protocols. The acute oral LD50 was 1098 mg/kg bw, and the acute dermal LD50 was > 1000 mg/kg bw and < 2000 mg/kg bw. An acute inhalation toxicity, showing no effect above 5000 mg/m3, is read-across from a category member, n-DDSA. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/502727e0-07b6-4e49-8fe9-27aab796d0a1/documents/IUC5-906e5f5c-15eb-4089-9d8f-e3a946bcfe8c_ce8580fe-252c-4728-8926-c75f9793477f.html,,,,,, "3-(oct-2-en-1-yl)dihydrofuran-2,5-dione",42482-06-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/502727e0-07b6-4e49-8fe9-27aab796d0a1/documents/IUC5-906e5f5c-15eb-4089-9d8f-e3a946bcfe8c_ce8580fe-252c-4728-8926-c75f9793477f.html,,oral,LD50,"1,098 mg/kg bw",adverse effect observed, "3-(oct-2-en-1-yl)dihydrofuran-2,5-dione",42482-06-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/502727e0-07b6-4e49-8fe9-27aab796d0a1/documents/IUC5-906e5f5c-15eb-4089-9d8f-e3a946bcfe8c_ce8580fe-252c-4728-8926-c75f9793477f.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, "3-(oct-2-en-1-yl)dihydrofuran-2,5-dione",42482-06-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/502727e0-07b6-4e49-8fe9-27aab796d0a1/documents/IUC5-906e5f5c-15eb-4089-9d8f-e3a946bcfe8c_ce8580fe-252c-4728-8926-c75f9793477f.html,,inhalation,LC50,"5,300 mg/m3",no adverse effect observed, 3-Ethenyl-5-methyl-2-oxazolidinone,3395-98-0, Key study: 90 day repeated dose toxicitiy study (OECD 408); NOAEL: 15 mg/kg bw/d Supporting screening study (OECD 422) ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0117dcae-f280-45b0-8c96-daa91296e86d/documents/8e558251-1520-43fd-a577-d23a323faade_368ddf42-a06c-461c-8b45-73e5f0f8a448.html,,,,,, 3-Ethenyl-5-methyl-2-oxazolidinone,3395-98-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0117dcae-f280-45b0-8c96-daa91296e86d/documents/8e558251-1520-43fd-a577-d23a323faade_368ddf42-a06c-461c-8b45-73e5f0f8a448.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat 3-Ethenyl-5-methyl-2-oxazolidinone,3395-98-0,LD50 oral: >300 - < 2000 mg/kgLD50 dermal: > 2000 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0117dcae-f280-45b0-8c96-daa91296e86d/documents/IUC5-34679ff7-13a8-4e02-b5e5-9e56f5494967_368ddf42-a06c-461c-8b45-73e5f0f8a448.html,,,,,, "2-Oxepanone, polymer with 1,4-butanediol",31831-53-5," A 90 -day rat study is available for the submission substance 2 -oxepanone, polymer with 1,4-butanediol (CAPA 2043). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f340f6d6-2972-4a27-aa14-c5de1160b716/documents/6db83225-de61-4038-be12-083c77550221_c1b64fac-ac43-4299-8af5-e92a8181049b.html,,,,,, "2-Oxepanone, polymer with 1,4-butanediol",31831-53-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f340f6d6-2972-4a27-aa14-c5de1160b716/documents/6db83225-de61-4038-be12-083c77550221_c1b64fac-ac43-4299-8af5-e92a8181049b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "2-Oxepanone, polymer with 1,4-butanediol",31831-53-5, A study of acute oral toxicity is available for the submission substance. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f340f6d6-2972-4a27-aa14-c5de1160b716/documents/566c13ed-f9e0-4481-b5ea-b281fcf0bd1c_c1b64fac-ac43-4299-8af5-e92a8181049b.html,,,,,, "2-Oxepanone, polymer with 1,4-butanediol",31831-53-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f340f6d6-2972-4a27-aa14-c5de1160b716/documents/566c13ed-f9e0-4481-b5ea-b281fcf0bd1c_c1b64fac-ac43-4299-8af5-e92a8181049b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Oxepanone, polymer with 1,6-hexanediol",36609-29-7," A 90 -day oral rat study is available for the submission substance CAPA 2047A ( 2-Oxepanone polymer with 1,6-hexanediol) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a796bd42-9fc0-4dcd-be7d-a8a7de54a311/documents/b3f2caaf-269a-4d30-9882-02b3271f8bee_d5237153-2b4a-4ca7-bd1b-da887b2882eb.html,,,,,, "2-Oxepanone, polymer with 1,6-hexanediol",36609-29-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a796bd42-9fc0-4dcd-be7d-a8a7de54a311/documents/b3f2caaf-269a-4d30-9882-02b3271f8bee_d5237153-2b4a-4ca7-bd1b-da887b2882eb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "2-Oxepanone, polymer with 1,6-hexanediol",36609-29-7," An acute oral toxicity study is available for the read-across (analogue) substance 2-Oxepanone, polymer with 1,4-butanediol (CAPA 203, now known as CAPA 2043). A waiver is proposed for acute inhalation toxicity based on exposure considerations. A waiver is proposed for acute dermal toxicity based on the low acute oral toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a796bd42-9fc0-4dcd-be7d-a8a7de54a311/documents/a4fe876d-92bc-4f40-8ae1-30a4b80d57bc_d5237153-2b4a-4ca7-bd1b-da887b2882eb.html,,,,,, "2-Oxepanone, polymer with 1,6-hexanediol",36609-29-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a796bd42-9fc0-4dcd-be7d-a8a7de54a311/documents/a4fe876d-92bc-4f40-8ae1-30a4b80d57bc_d5237153-2b4a-4ca7-bd1b-da887b2882eb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Oxetanone, 3-C14-16-alkyl 4-C15-17-alkylidene derivs.",98246-87-8,"Based on a study with oral exposure for 28 and 90 days (Central Toxicology Laboratory, UK, 2004), the predominant effect of AKD is the induction of generalised tissue inflammation. The inflammations are most likely not a specific response to AKD, but a generic response of rats to administration of higher molecular weight hydrocarbons. The relevance of this effect for humans is questionable, although it would be prudent to assume that the toxicity is relevant to humans and therefore the highest NOAEL is selected as the key value. The NOAEL for repeated oral uptake of AKD was established at 6.8 mg/kg bw/day in the 90-day rat feeding study.The findings in the EOGRTS study (Charles River 2021), where male and female rats received oral doses up to 250 mg/kg bw during a 10 week pre-mating period showed very limited inflammatory responses in the adrenals and kidneys of the parental animals at the highest dose. These effects were not considered to be adverse and the NOAEL in this study was set at 250 mg/kg bw. In the F1 generation that was indirectly exposed during gestation and lactation and directly (by gavage) until day 97 post-natal, no adverse effects were noted at any of the dose levels. The NOAEL for reproduction and developmental toxicity as well as the NOAEL for general toxicity was 250 mg/kg bw. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0de794f4-ea40-47f7-b058-bc5259d9a11c/documents/IUC5-0afeba99-dced-42cf-aa37-f2aef4fab092_8f5acda0-2cdc-41bf-a990-988c347fe302.html,,,,,, "2-Oxetanone, 3-C14-16-alkyl 4-C15-17-alkylidene derivs.",98246-87-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0de794f4-ea40-47f7-b058-bc5259d9a11c/documents/IUC5-0afeba99-dced-42cf-aa37-f2aef4fab092_8f5acda0-2cdc-41bf-a990-988c347fe302.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "2-Oxetanone, 3-C14-16-alkyl 4-C15-17-alkylidene derivs.",98246-87-8,"Oral, rat: The key study is a study with the structural analogue branched AKD (P-2290, CAS 849705-80-2, Huntingdon 1999) performed according to current guidelines and under GLP. The LD50 from this study is > 2000 mg/kg bw.Dermal, rat: The acute LD50 for rats of the structural analogue branched AKD (P-2290; Huntingdon 1999) was demonstrated to be > 2000 mg/kg bodyweight per formed according OECD TG 402 and GLP.For acute inhalation toxicity a valid study is not available. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): In a weight of evidence approach based on data on the substance and a close analogue, it was concluded that the LD50 of the substance is > 2000 mg/kg bw Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Study waived based on low acute oral toxicity and a study on a structural analogue. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0de794f4-ea40-47f7-b058-bc5259d9a11c/documents/IUC5-747f68d6-e7fa-4f9b-acfa-3416a5451362_8f5acda0-2cdc-41bf-a990-988c347fe302.html,,,,,, "2-Oxetanone, 3-C14-16-alkyl 4-C15-17-alkylidene derivs.",98246-87-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0de794f4-ea40-47f7-b058-bc5259d9a11c/documents/IUC5-747f68d6-e7fa-4f9b-acfa-3416a5451362_8f5acda0-2cdc-41bf-a990-988c347fe302.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Oxetanone, 3-C14-16-alkyl 4-C15-17-alkylidene derivs.",98246-87-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0de794f4-ea40-47f7-b058-bc5259d9a11c/documents/IUC5-747f68d6-e7fa-4f9b-acfa-3416a5451362_8f5acda0-2cdc-41bf-a990-988c347fe302.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-oxocyclohexane-1,1,3,3-tetrapropionic acid",5107-67-5,- LD50 in male rats: greater than 2000 mg/kg body weight.- LD50 in female rats: greater than 2000 mg/kg body weight.- LD50 in rats of both sexes: greater than 2000 mg/kg body weight. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/066bfe85-233b-420f-a74e-5a498e1a379f/documents/IUC5-8d43ccd5-0fd4-40f4-83b7-1d3f7a0de22d_4da99565-b46a-40a4-b143-349ef94b5d9a.html,,,,,, "2-oxocyclohexane-1,1,3,3-tetrapropionic acid",5107-67-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/066bfe85-233b-420f-a74e-5a498e1a379f/documents/IUC5-8d43ccd5-0fd4-40f4-83b7-1d3f7a0de22d_4da99565-b46a-40a4-b143-349ef94b5d9a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-pentanone O,O',O'',O'''-silanetetrayltetraoxime",1170315-92-0,"Key study: Based on the read-across approach from the analogue substance MPKO, the NOAEL after at least 28 days of oral exposure was determined to be 16 mg/kg bw/day . ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7bb0325a-c795-4a96-9a7d-7f5fe978ec88/documents/IUC5-8bfeaaad-f88d-4cfb-bb7c-b1ebaad11ef1_fbb6fa0f-191a-44c5-b891-92c34c57fe85.html,,,,,, "2-pentanone O,O',O'',O'''-silanetetrayltetraoxime",1170315-92-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7bb0325a-c795-4a96-9a7d-7f5fe978ec88/documents/IUC5-8bfeaaad-f88d-4cfb-bb7c-b1ebaad11ef1_fbb6fa0f-191a-44c5-b891-92c34c57fe85.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,16 mg/kg bw/day,,rat "2-pentanone O,O',O'',O'''-silanetetrayltetraoxime",1170315-92-0,"Weight of Evidence: Acute oral toxicity: Based on the read-across apporach from the analogue OS1600, the oral LD50 was determined to be 1540 mg/kg bw.Weight of Evidence: Acute oral toxicity: Based on the read-across apporach from the analogue OS2600, the oral LD50 was determined to be between 1206 and 2411 mg/kg bw.Weight of Evidence: Acute toxicity oral: Based on the read-across apporach from the analogue MPKO, the oral LD50 was determined to be 1200 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bb0325a-c795-4a96-9a7d-7f5fe978ec88/documents/IUC5-8a98176a-b8fc-496c-91b9-569df55a2383_fbb6fa0f-191a-44c5-b891-92c34c57fe85.html,,,,,, "2-pentanone O,O',O'',O'''-silanetetrayltetraoxime",1170315-92-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bb0325a-c795-4a96-9a7d-7f5fe978ec88/documents/IUC5-8a98176a-b8fc-496c-91b9-569df55a2383_fbb6fa0f-191a-44c5-b891-92c34c57fe85.html,,oral,LD50,"1,200 mg/kg bw",adverse effect observed, "2-Pentanone, O,O',O''-(ethenylsilylidyne)trioxime",58190-62-8," Key study: Based on the read-across approach from the analogue substance MPKO, the NOAEL after at least 28 days of oral exposure was determined to be 18 mg/kg bw/day . Key study: Based on the read-across approach from experimental results on analogue OS2200, the NOAEL for 13 weeks repeated dose toxicity by oral route in rats was estimated to be 13 mg/kg-bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17fa6529-7926-43a2-bd19-2f99ba8b9f47/documents/IUC5-aaa0f455-ae98-4a10-b134-82de53450adf_9f0ad6c3-7562-4a72-9a26-c1bb5aef2f57.html,,,,,, "2-Pentanone, O,O',O''-(ethenylsilylidyne)trioxime",58190-62-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17fa6529-7926-43a2-bd19-2f99ba8b9f47/documents/IUC5-aaa0f455-ae98-4a10-b134-82de53450adf_9f0ad6c3-7562-4a72-9a26-c1bb5aef2f57.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,13 mg/kg bw/day,,rat "2-Pentanone, O,O',O''-(ethenylsilylidyne)trioxime",58190-62-8," Acute toxicity oral: The oral LD50 of OS2600 was determined to be within the range of 1000-2000 mg/kg bw in rats. The LD50 of MPKO, the hydrolysis product of OS2600, was determined to be ca 1133 mg/kg bw in rats. Acute toxicity dermal: Based on the read-across approach from the analogue substance OS2200, the acute lethal dermal dose to rats of OS2600 was determined to be greater than 1786 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17fa6529-7926-43a2-bd19-2f99ba8b9f47/documents/IUC5-4091917b-6550-4203-9e6d-ca19e71be758_9f0ad6c3-7562-4a72-9a26-c1bb5aef2f57.html,,,,,, "2-Pentanone, O,O',O''-(ethenylsilylidyne)trioxime",58190-62-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17fa6529-7926-43a2-bd19-2f99ba8b9f47/documents/IUC5-4091917b-6550-4203-9e6d-ca19e71be758_9f0ad6c3-7562-4a72-9a26-c1bb5aef2f57.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, "2-Pentanone, O,O',O''-(ethenylsilylidyne)trioxime",58190-62-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17fa6529-7926-43a2-bd19-2f99ba8b9f47/documents/IUC5-4091917b-6550-4203-9e6d-ca19e71be758_9f0ad6c3-7562-4a72-9a26-c1bb5aef2f57.html,,dermal,LD50,"1,786 mg/kg bw",no adverse effect observed, "2-Pentanone, O,O',O''-(phenylsilylidyne)trioxime",1170315-90-8,"Key study: Based on the read-across approach from the analogue substance MPKO, the NOAEL after at least 28 days of oral exposure was determined to be 20 mg/kg bw/day .Key study: Based on the read-across approach from the analogue substance OS2200, the NOAEL after 90 days of oral exposure was determined to be 10 mg/kg bw/day . ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af8f9a79-3cb6-4a64-b2f2-735cd1522e3f/documents/IUC5-a79818c6-9fef-41f4-b627-08cbea606dcf_32eb19d2-4a3b-4575-b76e-d9824d735304.html,,,,,, "2-Pentanone, O,O',O''-(phenylsilylidyne)trioxime",1170315-90-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af8f9a79-3cb6-4a64-b2f2-735cd1522e3f/documents/IUC5-a79818c6-9fef-41f4-b627-08cbea606dcf_32eb19d2-4a3b-4575-b76e-d9824d735304.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "2-Pentanone, O,O',O''-(phenylsilylidyne)trioxime",1170315-90-8,"Acute oral toxicity: WoE: Based on the read-across approach from the analogue OS1600, the oral LD50 was determined to be 1457 mg/kg bw.Acute oral toxicity: WoE: Acute oral toxicity: Based on the read-across approach from the analogue OS2600, the oral LD50 was determined to be between 1141 and 2282 mg/kg bw.Acute oral toxicity: WoE: Acute toxicity oral: Based on the read-across approach from the analogue MPKO, the oral LD50 was determined to be 1457 mg/kg bw.Acute dermal toxicity: Key study: Acute toxicity dermal: Based on the read-across approach from the analogue OS2200, the dermal LD50 was determined to be >1392 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af8f9a79-3cb6-4a64-b2f2-735cd1522e3f/documents/IUC5-952a34d5-ef2b-4f92-acd6-38b3b96ecd85_32eb19d2-4a3b-4575-b76e-d9824d735304.html,,,,,, "2-Pentanone, O,O',O''-(phenylsilylidyne)trioxime",1170315-90-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af8f9a79-3cb6-4a64-b2f2-735cd1522e3f/documents/IUC5-952a34d5-ef2b-4f92-acd6-38b3b96ecd85_32eb19d2-4a3b-4575-b76e-d9824d735304.html,,oral,LD50,"1,143 mg/kg bw",adverse effect observed, "2-Pentanone, O,O',O''-(phenylsilylidyne)trioxime",1170315-90-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af8f9a79-3cb6-4a64-b2f2-735cd1522e3f/documents/IUC5-952a34d5-ef2b-4f92-acd6-38b3b96ecd85_32eb19d2-4a3b-4575-b76e-d9824d735304.html,,dermal,discriminating dose,"1,392 mg/kg bw",no adverse effect observed, "2-Pentanone, 4-methyl-, reaction products with 2-(2-aminoethoxy)ethanol",72480-17-2," The oral administration of 2-[2-(4-methylpentan-2-ylideneamino)ethoxy]ethanol to rats for a period of up to eight weeks (including two weeks pre-pairing, gestation and early lactation for females) at dose levels 100, 300 and 1000 mg/kg bw/day (reduced to 600 mg/kg bw/day on Day 24), resulted in the early termination of three females treated at the high dosage group and treatment related microscopic effects in animals of either sex treated with 1000/ 600 mg/kg bw/day. A No Observed Effect Level (NOEL) for systemic toxicity was considered to be 300 mg/kg bw/day for either sex. The organ weight changes detected in the liver of males treated with 1000/600 mg/kg bw/day and the microscopic liver changes evident in these males were considered to be an adaptive response to treatment. Although the kidney findings of tubular basophilia (degenerating/ regenerating tubules) in male kidneys could be considered an adverse effect, this finding was considered to be associated with alpha 2u-globulin and formation of hyaline droplets, an effect recognized as being both species and sex specific and not relevant for humans. In terms of risk assessment, these findings observed on this study would suggest that a No Observed Adverse Effect Level (NOAEL) can be established at 1000/600 mg/kg bw/day for males because the findings do not reflect true systemic toxicity. The ‘No Observed Effect Level’ (NOEL) for reproductive toxicity was considered to be 300 mg/kg bw/day based on slight decreased values observed at the high dose level for which statistical significance was not achieved and may have been the result of one female which performed particularly poorly during lactation. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44db5c71-9d1f-4aa2-9320-f6ad59c65260/documents/599bbea8-b9e2-49a9-b389-115641e9ce99_d182b210-ed0e-4c6c-9560-679595127254.html,,,,,, "2-Pentanone, 4-methyl-, reaction products with 2-(2-aminoethoxy)ethanol",72480-17-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44db5c71-9d1f-4aa2-9320-f6ad59c65260/documents/599bbea8-b9e2-49a9-b389-115641e9ce99_d182b210-ed0e-4c6c-9560-679595127254.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2-Pentanone, 4-methyl-, reaction products with 2-(2-aminoethoxy)ethanol",72480-17-2," The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight (Globally Harmonized Classification System - Category 4). In accordance with section 2 of REACH (regulation(EC) No 1907/2006) Annex VIII, acute toxicity via dermal and inhalation routes (required in Annex VIII section 8.5) does not need to be conducted as the substance is classified as corrosive to the skin. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44db5c71-9d1f-4aa2-9320-f6ad59c65260/documents/ed74bfd9-a301-48fb-8b2d-aa12b1745367_d182b210-ed0e-4c6c-9560-679595127254.html,,,,,, "2-Pentanone, 4-methyl-, reaction products with 2-(2-aminoethoxy)ethanol",72480-17-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44db5c71-9d1f-4aa2-9320-f6ad59c65260/documents/ed74bfd9-a301-48fb-8b2d-aa12b1745367_d182b210-ed0e-4c6c-9560-679595127254.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, N-pentan-2-ylidenehydroxylamine,623-40-5," - LOAEL (OECD 422, oral, 28 days) = 15 mg/kg bw/day (no NOAEL could be determined) - NOAEC (OECD 412, inhalation, 14 days) = 616.7 mg/m³ - NOAEC (OECD 413, inhalation, 90 days) = 615.4 mg/m³ ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce916104-a43b-4b75-b1c4-f836676b739b/documents/9fa0f1b3-40b6-4905-a526-8b8c8f55b43d_10d593d6-e09c-4bd8-b343-c0105e56b22f.html,,,,,, N-pentan-2-ylidenehydroxylamine,623-40-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce916104-a43b-4b75-b1c4-f836676b739b/documents/9fa0f1b3-40b6-4905-a526-8b8c8f55b43d_10d593d6-e09c-4bd8-b343-c0105e56b22f.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,15 mg/kg bw/day,,rat N-pentan-2-ylidenehydroxylamine,623-40-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce916104-a43b-4b75-b1c4-f836676b739b/documents/9fa0f1b3-40b6-4905-a526-8b8c8f55b43d_10d593d6-e09c-4bd8-b343-c0105e56b22f.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,615.4 mg/m3,,rat N-pentan-2-ylidenehydroxylamine,623-40-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce916104-a43b-4b75-b1c4-f836676b739b/documents/9fa0f1b3-40b6-4905-a526-8b8c8f55b43d_10d593d6-e09c-4bd8-b343-c0105e56b22f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,243.1 mg/m3",no adverse effect observed,rat N-pentan-2-ylidenehydroxylamine,623-40-5," - Acute oral toxicity, rat (OECD 425): LD50 (f) 1133 mg/kg bw - Acute inhalation toxicity, rat (OECD 402): LC50 (m, f) > 295 ppm (corresponds to 1.22 mg/L) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce916104-a43b-4b75-b1c4-f836676b739b/documents/8bf17725-e1cf-4b45-a855-36f6df30f404_10d593d6-e09c-4bd8-b343-c0105e56b22f.html,,,,,, N-pentan-2-ylidenehydroxylamine,623-40-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce916104-a43b-4b75-b1c4-f836676b739b/documents/8bf17725-e1cf-4b45-a855-36f6df30f404_10d593d6-e09c-4bd8-b343-c0105e56b22f.html,,oral,LD50,"1,133 mg/kg bw",adverse effect observed, "2-Pentene, 1,1,1,2,3,4,5,5,5-nonafluoro-4-(trifluoromethyl)-, (E)-",3709-71-5,"Four repeat dose toxicity studies have been conducted on HFP Kinetic Dimer:28 Day Repeat Dose Oral Toxicity according to OECD 407 (1995): NOAEL 450 mg/kg/day28 Day Repeat Dose Inhalation Toxicity according to OECD 412 (1981): NOAEC 249.9 ppm (3.07 mg/L, vapor)28 Day Combined Repeated Dose Inhalation Toxicity and Reproductive/Developmental Screening according to OECD 421 (1995): NOAEC: 360 ppm (4.29 mg/L)13 week whole body Subchronic Inhalation study study according to OECD 413: NOAEC 250 ppm (3.0 mg/L) in males and 550 ppm (6.8 mg/L) in female rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/886c6d18-6a07-4952-aa54-dec88dadbf40/documents/f76b95a0-a24e-42f8-87a9-8d9b0ab39133_660e4bee-39b6-4fc7-a3ad-2dfdaea30a87.html,,,,,, "2-Pentene, 1,1,1,2,3,4,5,5,5-nonafluoro-4-(trifluoromethyl)-, (E)-",3709-71-5,Two reliable acute toxicity studies were conducted on HFP Kinetic Dimer. The results of the studies are: Acute Inhalation in Rats: 4-hour LC50 > 21.69 mg/L when tested according to OECD 403 (1981).Acute Oral in Rats: LD50 > 2000 mg/kg when tested according to OECD 423 (2002). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/886c6d18-6a07-4952-aa54-dec88dadbf40/documents/a2d6e95e-94f1-4884-b2fd-ccc17d974779_660e4bee-39b6-4fc7-a3ad-2dfdaea30a87.html,,,,,, "2-Pentene, 1,1,1,2,3,4,5,5,5-nonafluoro-4-(trifluoromethyl)-, (E)-",3709-71-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/886c6d18-6a07-4952-aa54-dec88dadbf40/documents/a2d6e95e-94f1-4884-b2fd-ccc17d974779_660e4bee-39b6-4fc7-a3ad-2dfdaea30a87.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-phenoxyisobutyric acid,943-45-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Method OECD 423 - experimental study LD50 > 2000 mg/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/841e2177-72ef-4e49-baed-838938306a36/documents/29b727fb-6719-4e8b-b7d0-44cf88e7d04d_9208768b-7381-4a74-b66f-8392146bc39e.html,,,,,, 2-Phenyl ethyl cyanoacrylate2-phenylethyl 2-cyanoprop-2-enoate,160583-22-2,"A study on repeated toxicity is waived due to high reactivity of 2-phenylethyl cyanoacrylate which makes testing not feasable. On contact with moisture, 2-phenylethyl cyanoacrylate polymerizes immediately. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8eb7eb6a-d762-4fbd-a105-a52131ef3ca8/documents/IUC5-91da8886-1a27-4e51-9da4-41ca2df59402_2f14c0cc-beda-4c51-a5fb-d3e68499bff3.html,,,,,, 2-Phenyl ethyl cyanoacrylate2-phenylethyl 2-cyanoprop-2-enoate,160583-22-2,Study is technically not feasible as 2-phenylethyl cyanoacrylate polymerizes within seconds on contact with moisture. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8eb7eb6a-d762-4fbd-a105-a52131ef3ca8/documents/IUC5-cee4161f-86b5-4f3d-ba99-3f5056e2af92_2f14c0cc-beda-4c51-a5fb-d3e68499bff3.html,,,,,, 2-phenylhexanenitrile,3508-98-3,"In a dietary reproscreen study according to OECD TG 421 several systemic parameters were scored in addition to what is required in the reproscreen in view of the systemic effects seen in the 28 -day oral gavage study. The doses were 13 and 16, 28 and 32 and 70-85 mg/kg bw for males and females, respectively (using the actual intake via food being 134, 284 and 770 ppm (200, 400 and 1000 nominal ppm Salicynalva in feed, respectively). Body weight and clinical signs were similar to control values. For haematology parameters no treatment related findings were seen up to the highest dose. Macroscopic and microscopic observations did not show treatment related effects. Relative liver weights were increased at 70 -80 mg/kg bw in both sexes, circa 10% for males and 20% for females. No organ weight effect were seen in: kidney, spleen, testes and epididymides. Considering systemic effects the NOAEL is considered to be 70 mg/kg bw for both males and females, using the lower value of the males on the intake of the substance. Though the liver weights at this dose are increased in the absence of any and macroscopic and microscopic findings this increase in liver weight is considered to be a non-adverse adaptive change. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The information on repeated dose toxicity from the 28-day study and the reproscreem are both of adequate quality to derive information on the systemic toxicity of the substance ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ac50f44-648a-469d-b277-94f2c1762815/documents/c1fe1751-1ddd-475e-96f3-eebe2886d4e7_c338cf7f-eac6-4a04-9373-0de3eaf32afe.html,,,,,, 2-phenylhexanenitrile,3508-98-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ac50f44-648a-469d-b277-94f2c1762815/documents/c1fe1751-1ddd-475e-96f3-eebe2886d4e7_c338cf7f-eac6-4a04-9373-0de3eaf32afe.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,70 mg/kg bw/day,,rat 2-phenylhexanenitrile,3508-98-3,"- Oral LD50 is >2000 mg/kg bw in an OECD TG 420- Dermal LD50 is >2000 mg/kg bw in an OECD 402 Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The one study available is of adequate quality. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The one study available is of adequate quality. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ac50f44-648a-469d-b277-94f2c1762815/documents/45711de7-accd-41b3-8e04-c5f73a53872c_c338cf7f-eac6-4a04-9373-0de3eaf32afe.html,,,,,, 2-phenylisobutyric acid,826-55-1,No reliable data are available. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e037007-07e2-43cc-949e-1b5fc97b2527/documents/IUC5-414e7896-3edd-4112-8697-8eddbbd0e5ad_bdd5d4ef-33b2-469d-8f41-d188130f2cef.html,,,,,, 2-phenylpropene,98-83-9,"Reliable studies are available for oral application as well as for exposure via inhalation.Oral (MHW Japan, 1997):Study design according to OECD Guideline No. 422NOEL: 40 mg/kg bwLOAEL: 200 mg/kg bw (based on histological changes in liver and kidneys of both sexes and in thymus of female rats; increase in GPT in male rats)Inhalation (rats & mice; NTP, 2007)Study design comparable to OECD Guideline No. 413NOAEL: 150 ppm for males (based on kidney & liver weights)Inhalation (several species; Wolf et al., 1956)6 months, 7h/d, 5d/weekNOAEL: 200 ppm (based on kidney & liver, reduction in growth)Dermal:For the dermal route there are no data available. However, as inhalation is the most important route of exposure and for this endpoint a recent NTP study in rats and mice is available, no dermal repeated dose toxicity study is considered to be needed or scientifically justified. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04917556-fc8e-4e01-b3fc-21e3ac74ec76/documents/IUC5-724b418c-3a73-4fd4-9769-360286fcf64d_a336f1d1-400e-49fa-a0a7-3f01400d2ef3.html,,,,,, 2-phenylpropene,98-83-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04917556-fc8e-4e01-b3fc-21e3ac74ec76/documents/IUC5-724b418c-3a73-4fd4-9769-360286fcf64d_a336f1d1-400e-49fa-a0a7-3f01400d2ef3.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,200 mg/kg bw/day,,rat 2-phenylpropene,98-83-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04917556-fc8e-4e01-b3fc-21e3ac74ec76/documents/IUC5-724b418c-3a73-4fd4-9769-360286fcf64d_a336f1d1-400e-49fa-a0a7-3f01400d2ef3.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,984 mg/m3,,monkey 2-phenylpropene,98-83-9,"oral LD50 (rat): ca. 4900 mg/kg bw (key study: Wolf et al., 1956)inhalation LC50 (6 hrs; rat): ca. 22850 mg/m3 (key study: Monsanto Co., 1972)dermal LD50 (NZW rabbit): ca. 14560 mg/kg bw (key study: Union Carbide Co., 1975) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04917556-fc8e-4e01-b3fc-21e3ac74ec76/documents/IUC5-c500a820-2beb-43d8-be50-25cbd3cc8ae2_a336f1d1-400e-49fa-a0a7-3f01400d2ef3.html,,,,,, 2-phenylpropene,98-83-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04917556-fc8e-4e01-b3fc-21e3ac74ec76/documents/IUC5-c500a820-2beb-43d8-be50-25cbd3cc8ae2_a336f1d1-400e-49fa-a0a7-3f01400d2ef3.html,,oral,LD50,"4,900 mg/kg bw",, 2-phenylpropene,98-83-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04917556-fc8e-4e01-b3fc-21e3ac74ec76/documents/IUC5-c500a820-2beb-43d8-be50-25cbd3cc8ae2_a336f1d1-400e-49fa-a0a7-3f01400d2ef3.html,,dermal,LD50,"14,560 mg/kg bw",, 2-phenylpropene,98-83-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04917556-fc8e-4e01-b3fc-21e3ac74ec76/documents/IUC5-c500a820-2beb-43d8-be50-25cbd3cc8ae2_a336f1d1-400e-49fa-a0a7-3f01400d2ef3.html,,inhalation,LC50,"22,850 mg/m3",, 2-piperazin-1-ylethanol,103-76-4," Exposure based adaptation of information requirements: According to REGULATION (EC) No 1907/2006, Annex IX and Annex X, repeated dose/reproduction toxicity testing (section 8.6/section 8.7) may be omitted, if relevant human exposure can be excluded in accordance with Annex XI section 3. Furthermore and in accordance with section 3.2 (b) of Annex XI (as amended by Regulation 134/2009), testing for repeated dose toxicity/reproduction toxicity can be omitted when the substance is not incorporated in an article and the manufacturer can demonstrate and document for all relevant scenarios that throughout the life cycle strictly controlled as well as rigorously contained conditions as set out in Article 18(4)(a) to (f) (Regulation 1907/2006) apply.   Life-cycle stage(s) covered: 1. Production of Hydroxyethylpiperazine (PROCs 1, 2, 3, 8b, 15) 2. Formulation of Hydroxyethylpiperazine into a mixture (PROCs 1, 2, 3) 3. Use of Hydroxyethylpiperazine in gas treatment (PROCs 1, 2, 3) 4. Intermediate use (PROCs 1, 2, 3, 15)   Classification: H315: Causes skin irritation. H318: Causes serious eye damage.   The substance is considered as corrosive to the eyes and capable of causing skin irritating effects. Based on the bacterial reverse mutation assay, the HPRT assay, and the CA test the test substance is not considered to induce gene mutations neither in the absence nor in the presence of a metabolic activation system.     1.    Process description: PRODUCTION Piperazine solution and ethylenoxide are transferred via closed pipelines to thereactor. After the flow and temperature controlled reaction is completed, the produced crude hydroxyethylpiperazine (HEP) is transferred via a closed pipeline to the distillation column. Sampling is done with a closed system. The whole process is operated discontinuously at elevated temperature. The reactor is located indoors. Due to the closed system, exposure to workers will not take place under normal operation conditions. In the distillation process the crude HEPis separated in 3 fractions: light boiler, intermediate fraction and the pure fraction. The residue remains in the distillation vessel. The pure product is pumped from the vessel via a closed pipeline to the drum filling station. Transfers, storage tank, reactor, processing equipment and feeds are operated in fully closed systems. Exposure is limited to occasional sampling tasks for quality control under strictly control conditions.Only a small, well-defined and trained group of workers is exposed occasionally to low levels using appropriate risk management measures to minimize exposure.   2.    Process description GAS TREATMENT: The Feed Gas enters the Absorber at the bottom. The lean solution is fed at the top of the absorber and hence the liquid and the gas are getting in contact in a counter-current flow. The mass and heat exchange is performed in the packing sections installed in the absorber. The Treated Gas leaves the Absorber with a CO2 concentration < 2% as desired, to the pipeline or for further processing. The rich solution from the bottom of the absorber is fed to the HP flash vessel, operated at a pressure level between absorber pressure and Stripper pressure. A level control valve is used to reduce the pressure of the rich solution from the level of the absorber to the level of the HP flash. The Flash Gas from the HP flash vessel contains the major part of the dissolved inert gases, i.e. non-acid gases like methane, and a minor part of the acid gas. The solution is heated up in the heat exchanger whereby a smaller amount of gas might be released from the solution. A larger amount of gas is released after the solution has passed the let-down valve, which controls the level in the HP flash vessel. The solution is then flashed at the top of the Stripper where vapor and liquid separate. Most of the absorbed CO2 and H2S is stripped off by steam generated in the reboiler. The regenerated solution leaves the stripper bottom with only a very low residual acid gas loading. The heat from this stream is partly recovered in the heat exchanger. The Stripper vessel is furnished with a packed bed in order to provide a large surface area required to release the CO2. The lean solution is then cooled down further in the lean solution cooler and fed to the top of the lean absorber. A reflux condenser is installed on top of the Stripper vessel for cooling down the released acid gas and condensing a part of the steam. The remaining gas stream with the major part of the acid gas (Acid Off-Gas) leaves the condenser for downstream processing. The condensate is pumped back to the top of the Stripper vessel. An appropriate amount of water is fed to the unit for balancing the amount of vapor leaving the unit with the gas streams. All vessels, pumps, heat exchangers, processing equipment and feeds are operated in fully closed systems. Exposure is limited to occasional sampling and shutdown tasks for quality control under strictly control conditions. Only a small, well-defined and trained group of workers is exposed occasionally to low levels using appropriate risk management measures to minimize exposure. The whole process is operated continuously at elevated temperature and pressure. All vessels are located outdoors. Due to the closed system, exposure to workers will not take place under normal operation conditions.   Rigorous containment measures: The substance is manufactured and used under strictly controlled conditions over the entire life cycle. Exposure is limited to occasional sampling tasks for quality control, as well as to charging and discharging processes. Transport, storage tanks, reactors, processing equipment, and feeds operate in fully closed systems.   Procedural and control technologies are used to minimize residual emissions/exposure as well as qualitative risk considerations: Operational and technical conditions and measures affecting and controlling workers exposure, such as local exhaust ventilation as well as personal protective equipment, such as goggles, chemically resistant gloves, and respiratory protection where potential exposure may occur as reported in the CSR are followed (see chapters 9 &10). On the basis of the described process conditions, testing of Repeated Dose Toxicity (OECD TG 407) as well as Reproductive Toxicity (OECD TG 421 or 422) was not performed since the criteria of exposure based adaptation of information requirements are met. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de660874-6fbf-4943-9ddc-104ce090e253/documents/060dbc49-e5f0-4f89-8955-7e23fc09afcc_869eca37-0690-4471-98a6-70157cf1db67.html,,,,,, 2-piperazin-1-ylethanol,103-76-4, oral: LD50 ca. 4244 mg/kg bw (rat) inhalation: no mortality/clinical signs observed (rat) intraperitoneal: LD50 < 678 mg/kg bw (mice) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de660874-6fbf-4943-9ddc-104ce090e253/documents/2c74d007-6e5f-4cb9-9d54-ad0d8dc1f3fe_869eca37-0690-4471-98a6-70157cf1db67.html,,,,,, 2-piperazin-1-ylethanol,103-76-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de660874-6fbf-4943-9ddc-104ce090e253/documents/2c74d007-6e5f-4cb9-9d54-ad0d8dc1f3fe_869eca37-0690-4471-98a6-70157cf1db67.html,,oral,LD50,"4,244 mg/kg bw",adverse effect observed, 2-piperazin-1-ylethylamine,140-31-8,"An OECD 422 guideline study, ""Combined Repeated Dose Toxicity Study with the Reproductive/Developmental Toxicity Screen Test, was conductedon Sprague Dawley rats at doses of 0, 500, 2000 ppm and 8000 ppm of aminoethyl piperazine (AEP) administered via the drinking water.An OECD 90 day rat inhalation study was conducted with 90 day recovery via nose only exposures. Male and female F34 rats were exposed 6 h/day, 5 days/wk for 13 wks (a total of 65 exposure days) to 0, 0.2, 5.1, or 53.5 mg AEP/m3. All exposure-related effects were consistent with point-of-contact irritation of the upper and lower airway epithelium. No treatment-related histopathologic lesions observed in the upper or lower respiratory tract of male or female rats exposed to 0.2 mg AEP/m3 (NOEC). No histopathologic evidence of treatment-related systemic toxicity was observed in any AEP-exposed rats including rats exposed to the highest concentration of 53.5 mg AEP/m3. Female rats exposed to 53.5 mg AEP/m3 had higher absolute and relative mean lung weights, compared to control rats.Exposure-related lesions in the larynx, trachea and lungs were limited to rats exposed to 53.5 mg AEP/m3. Rats exposed to 5.1 and 53.5 mg AEP/m3 had concentration-dependent nasal airway lesions.Exposure-related lesions in the 13-week recovery groups persisted in the nasal tissues of male rats exposed to 5.1 and 53.5 mg AEP/m3 and the larynx and lungs of males exposed to 53.5 mg AEP/m3. The repeated dose dermal administration of AEP resulted in dose-related iritative effects at the test site in male rats at 100, 500, or 1000 mg/kg/day and in female rats at 500 and 1000 mg/kg/day. There was no systemic toxicity at any of the dose levels. The NOEL was considered to be ≥ 1000 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a53d20c4-97a1-410a-ae68-745cea349901/documents/129752e5-3353-46b5-b8db-bae803f3effb_d5498c3f-5b60-409d-a631-0a79cd21ea74.html,,,,,, 2-piperazin-1-ylethylamine,140-31-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a53d20c4-97a1-410a-ae68-745cea349901/documents/129752e5-3353-46b5-b8db-bae803f3effb_d5498c3f-5b60-409d-a631-0a79cd21ea74.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,">= 1,000 mg/kg bw/day",, 2-piperazin-1-ylethylamine,140-31-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a53d20c4-97a1-410a-ae68-745cea349901/documents/129752e5-3353-46b5-b8db-bae803f3effb_d5498c3f-5b60-409d-a631-0a79cd21ea74.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,152 mg/kg bw/day,,rat 2-piperazin-1-ylethylamine,140-31-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a53d20c4-97a1-410a-ae68-745cea349901/documents/129752e5-3353-46b5-b8db-bae803f3effb_d5498c3f-5b60-409d-a631-0a79cd21ea74.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,>= 53.5 mg/m3,,rat 2-piperazin-1-ylethylamine,140-31-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a53d20c4-97a1-410a-ae68-745cea349901/documents/129752e5-3353-46b5-b8db-bae803f3effb_d5498c3f-5b60-409d-a631-0a79cd21ea74.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.2 mg/m3,adverse effect observed,rat 2-piperazin-1-ylethylamine,140-31-8,The acute oral LD50 in rats is 2140 mg/kg and the 24 hour dermal LD50 in rabbits is 866 mg/kg. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a53d20c4-97a1-410a-ae68-745cea349901/documents/7d4eb9c6-2d29-41c5-866c-4bdd547c6bb0_d5498c3f-5b60-409d-a631-0a79cd21ea74.html,,,,,, 2-piperazin-1-ylethylamine,140-31-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a53d20c4-97a1-410a-ae68-745cea349901/documents/7d4eb9c6-2d29-41c5-866c-4bdd547c6bb0_d5498c3f-5b60-409d-a631-0a79cd21ea74.html,,oral,LD50,"2,140 mg/kg bw",adverse effect observed, 2-piperazin-1-ylethylamine,140-31-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a53d20c4-97a1-410a-ae68-745cea349901/documents/7d4eb9c6-2d29-41c5-866c-4bdd547c6bb0_d5498c3f-5b60-409d-a631-0a79cd21ea74.html,,dermal,LD50,866 mg/kg bw,adverse effect observed, 2-piperidinoethanol,3040-44-6, OECD 422: NOAEL for systemic effects = 250 mg/kg bw/d (highest tested dose) in males and 75 mg/kg bw/d in females ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31a116d9-749b-444f-8fa6-a2054a52881b/documents/614fd63a-c1af-45ec-8fef-a3b15efe3129_211b9054-96f4-43b3-8356-4cfcead27ad6.html,,,,,, 2-piperidinoethanol,3040-44-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31a116d9-749b-444f-8fa6-a2054a52881b/documents/614fd63a-c1af-45ec-8fef-a3b15efe3129_211b9054-96f4-43b3-8356-4cfcead27ad6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat 2-piperidinoethanol,3040-44-6," The oral LD50 in rats was approx. 11000 mg/kg body weight (well-documented non-guideline, non-GLP study)   The dermal LD50 in rats was > 1000 < 2000 mg/kg body weight (well-documented non-guideline, non-GLP study) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31a116d9-749b-444f-8fa6-a2054a52881b/documents/2352444c-50cb-424c-bd19-5ed6f10384c7_211b9054-96f4-43b3-8356-4cfcead27ad6.html,,,,,, 2-piperidinoethanol,3040-44-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31a116d9-749b-444f-8fa6-a2054a52881b/documents/2352444c-50cb-424c-bd19-5ed6f10384c7_211b9054-96f4-43b3-8356-4cfcead27ad6.html,,oral,LD50,"1,100 mg/kg bw",adverse effect observed, 2-piperidinoethanol,3040-44-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31a116d9-749b-444f-8fa6-a2054a52881b/documents/2352444c-50cb-424c-bd19-5ed6f10384c7_211b9054-96f4-43b3-8356-4cfcead27ad6.html,,dermal,discriminating dose,"1,000 mg/kg bw",adverse effect observed, "2-Propanamine, compd. with boron trifluoride, reaction products with Bu glycidyl ether",68478-97-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e3b56ab-a6ab-466d-88d8-631465977020/documents/a32436ce-85e9-4a2d-bcb9-4b134e657a65_de3f2300-62c9-480c-abe3-869244c95873.html,,oral,LD50,730 mg/kg bw,adverse effect observed, "2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs.",97592-79-5,"The potential toxicity of the substance following repeated administration was investigated according to OECD guideline 422 and EPA guideline OPPTS 870.3650 (Takawale, 2010). The NOAEL by oral route was established to 24 mg/kg bw/day.No Repeated-dose toxicity studies by inhalation or dermal route were available. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/24160f2f-ed8b-4432-83ab-f82fa9574804/documents/IUC5-d6fa1b67-42a0-43be-a4ea-d71c05acff5b_efd591b2-ae76-46b9-955d-ca5249347c97.html,,,,,, "2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs.",97592-79-5,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/24160f2f-ed8b-4432-83ab-f82fa9574804/documents/IUC5-d6fa1b67-42a0-43be-a4ea-d71c05acff5b_efd591b2-ae76-46b9-955d-ca5249347c97.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,24 mg/kg bw/day,,rat "2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs.",97592-79-5,"The acute oral toxicity of the substance was assessed using:- an acute oral toxicity test performed in rats according to OECD 401 guideline and Good Laboratory Practices (Dufour, 1997)The substance is of moderate acute toxicity following oral exposure:The oral LD50 was comprised between 500 and 2000 mg/kg bw in rats.. The acute dermal toxicity of the substance was assessed using:- An acute dermal toxicity test performed in rats according to OECD 402 guideline and Good Laboratory Practices (Manciaux, 1998).The substance is of low acute toxicity following dermal exposure:The oral LD0 was found to be greater than 2000 mg/kg bw.No inhalation toxicity study was performed on the substance due to its corrosive properties. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24160f2f-ed8b-4432-83ab-f82fa9574804/documents/IUC5-a5ab4771-14f9-4a41-b9ae-1ae7c93492b7_efd591b2-ae76-46b9-955d-ca5249347c97.html,,,,,, "2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs.",97592-79-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24160f2f-ed8b-4432-83ab-f82fa9574804/documents/IUC5-a5ab4771-14f9-4a41-b9ae-1ae7c93492b7_efd591b2-ae76-46b9-955d-ca5249347c97.html,,dermal,LD50,"2,000 mg/kg bw",, "1,3-bis(2,6-dimethylphenoxy)propan-2-ol",856976-65-3,The oral LD50 in Wister rats was >2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b02bc55f-b95d-4f5e-9cd5-18711f0bdea9/documents/IUC5-be6be78f-24dd-4578-80a8-8b7d6b29cc5d_92640942-4e01-4228-a99b-47eb0448fe90.html,,,,,, "2-Propanol, 1,3-bis[(3-methyl-2-buten-1-yl)oxy]-",2337348-25-9,Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyInformation.KeyInformation): DPNG does not fulfill the criteria for classification as acute toxic for the oral pathway under CLP ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/943b19fb-4414-4323-a4ea-8660c648be34/documents/e4a9180b-db60-475d-b4b0-41b19d0331ad_1526681a-26d7-4878-a896-0dc10833b78e.html,,,,,, "2-Propanol, 1,3-bis[(3-methyl-2-buten-1-yl)oxy]-",2337348-25-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/943b19fb-4414-4323-a4ea-8660c648be34/documents/e4a9180b-db60-475d-b4b0-41b19d0331ad_1526681a-26d7-4878-a896-0dc10833b78e.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 1-butoxy-3-(prop-2-en-1-yloxy)propan-2-ol,53146-45-5, Repeated dose toxicity: Oral NOAEL for developmental toxicity: 450 mg/kg/day NOAEL for systemic toxicity in males: 25 mg/kg/day NOAEL for systemic toxicity in females: 450 mg/kg/day ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb61fd4b-58c2-4d35-9719-969c4ca38c7a/documents/068271a0-afb5-410f-bfa2-89f2061106b2_ae3d986b-c718-47b6-badc-010538a1114d.html,,,,,, 1-butoxy-3-(prop-2-en-1-yloxy)propan-2-ol,53146-45-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb61fd4b-58c2-4d35-9719-969c4ca38c7a/documents/068271a0-afb5-410f-bfa2-89f2061106b2_ae3d986b-c718-47b6-badc-010538a1114d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat 1-butoxy-3-(prop-2-en-1-yloxy)propan-2-ol,53146-45-5," LD50, Oral, Rat: 300mg/kg 2000 mg/kg bw in female CRL:(WI) rats. Acute Toxicity: Dermal LD50 > 2000 mg/kg bw in female CRL: (WI) rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a9c286a-3db7-4ee4-89f9-84dfe87966e3/documents/2f381ccc-1830-406a-b1d9-66b6a409f9fd_0712b18c-f92b-46d8-b625-ea19a1d3310b.html,,,,,, "2-Propanone, reaction products with diphenylamine",68412-48-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a9c286a-3db7-4ee4-89f9-84dfe87966e3/documents/2f381ccc-1830-406a-b1d9-66b6a409f9fd_0712b18c-f92b-46d8-b625-ea19a1d3310b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Propanone, reaction products with diphenylamine",68412-48-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a9c286a-3db7-4ee4-89f9-84dfe87966e3/documents/2f381ccc-1830-406a-b1d9-66b6a409f9fd_0712b18c-f92b-46d8-b625-ea19a1d3310b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Propen-1-amine, N-2-propenyl-, hydrochloride",6147-66-6,"The Acute Oral toxicity of test item 2-propen-1-amine, N-2-propen1-yl, hydrochloride was determined according to OECD Guideline 420 under GLP compliance. The fixed dose method was used.  One female rat received by gavage a single dose of 300 mg/kg body weight in water.  In the absence of observable toxicity at 300 mg/kg body weight, an animal was treated at 2000 mg/kg body weight.  Considering that no mortality of clear clinical signs of toxicity were observed, four additional female rats were treated at 2000 mg/kg body weight. Following exposure to the test substance, the animals were observed for 14 days.  Clinical observations were made at 30 minutes, 1, 2 and 4 hours after dosing and then daily until the end of the observation period.  Morbidity and mortality checkes were made twice daily.  Individual body weights were recorded on day 0 (day of dosing) and on days 8 and 15.  At the end of the observation period the animals were killed by carbon dioxide asphyxiation.  All animals were subject to gross necropsy.  No deaths occurred as a result to treatment and no clinical signs of toxicity were observed.  All animals showed expected gains in body weight over the observation period.  No abnormalities were noted at necropsy. It can be concluded that 2-propen-1-amine, N-2-propen-1-yl, hydrochloride has an LD50 >2000 mg/kg body weight via the oral route. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c251eaf2-0ff6-4af5-88bd-6cfc5fa775c2/documents/0f8f9e53-dbfd-413d-be3b-1542662e2787_12e1e116-a5e5-4340-b5e3-a4e1ec40edee.html,,,,,, "2-Propen-1-amine, N-2-propenyl-, hydrochloride",6147-66-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c251eaf2-0ff6-4af5-88bd-6cfc5fa775c2/documents/0f8f9e53-dbfd-413d-be3b-1542662e2787_12e1e116-a5e5-4340-b5e3-a4e1ec40edee.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "(2E)-3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-methylprop-2-enal",51575-61-2,"The oral LD50 of a stereoisomer of 2-Propenal, 3-(5,5-dimethyl-1,3-dioxan-2-yl)-2-methyl-, (E)- was determined to be >2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34899ab1-3079-452b-9955-436b086f0649/documents/IUC5-7f190318-a3d5-4358-b74a-99227a66f8e9_ed1a635c-39e6-4528-aa7b-467039f99955.html,,,,,, "(E)-3-(1,3-benzodioxol-5-yl)-N,N-diphenyl-prop-2-enamide",1309389-73-8,"In a key subchronic oral feeding study in rats according to OECD guideline 408, no clinical, histopathological, ophthalmological, body weight, body weight gain, food consumption, food efficiency changes, functional observational battery or motor activity results attributable to the substance administration were observed up to the highest tested concentration. However, it cannot be excluded that the reduction in thymus weight in the mid and high dose group (females) and decreases in WBC and in the white blood cell subpopulations in the high dose group (males and females) might be substance-related. Thus, using an endpoint-specific BMR of 19% for decrease WBC, BMDL–BMDU 90% confidence intervals of 124–781 and 101–1470 mg/kg bw/day were calculated for males and females, respectively. The lowest BMDL is 101 mg/kg bw/day (females) 124 mg/kg bw/day (males).   In a supporting 14-day range finding study in rats, the results indicate that male and female rats tolerate a repeated high dose dietary exposure of equal to or greater than 14000 ppm (corresponding to approx. 1381 mg/kg bw/day in females and 1443 mg/kg bw/day in males) of the test substance in a study of longer duration. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): RL 1 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb836ce6-926a-445a-9caf-014da0d3adbd/documents/IUC5-1365b245-865c-4bfa-9ec6-55ed459c878d_3a2fc298-46b3-47e2-a482-c05f3a9650f3.html,,,,,, "(E)-3-(1,3-benzodioxol-5-yl)-N,N-diphenyl-prop-2-enamide",1309389-73-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb836ce6-926a-445a-9caf-014da0d3adbd/documents/IUC5-1365b245-865c-4bfa-9ec6-55ed459c878d_3a2fc298-46b3-47e2-a482-c05f3a9650f3.html,Sub-chronic toxicity – systemic effects,oral,BMDL10,101 mg/kg bw/day,,rat "(E)-3-(1,3-benzodioxol-5-yl)-N,N-diphenyl-prop-2-enamide",1309389-73-8,"In the key acute oral toxicity study according to OECD guideline 423, the LD50 (female rats) was > 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb836ce6-926a-445a-9caf-014da0d3adbd/documents/IUC5-2082e57b-90b1-4228-98be-0da020166683_3a2fc298-46b3-47e2-a482-c05f3a9650f3.html,,,,,, "(E)-3-(1,3-benzodioxol-5-yl)-N,N-diphenyl-prop-2-enamide",1309389-73-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb836ce6-926a-445a-9caf-014da0d3adbd/documents/IUC5-2082e57b-90b1-4228-98be-0da020166683_3a2fc298-46b3-47e2-a482-c05f3a9650f3.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N-[4-[(4,6-dimethylpyrimidin-2-yl)sulfamoyl]phenyl]-2-methyl-prop-2-enamide",59941-98-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24f3a230-7c85-401c-bcee-8ff4df8d2cef/documents/9112c4d8-6875-481e-927e-a7f46177b878_e5bc5838-439f-4a87-841e-b5341ee59eef.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-Propenenitrile, polymer with 1,2-ethanediamine",28183-82-6," The substance is partly polymeric and the monomers and 'fragments' (groups) found by analysis using Mass Spectrometry have instead been assessed. Many of these low molecular weight amines are corrosive and are unsuitable for read-across, but data found for less irritating materials suggest low systemic toxicity. Low-molecular weight poltyamides are not considered hazardous at levels leading to GHS classification and are found in many uncooked and cooked foods. There is no apparent target organ effect; effects observed appear to be related to local effects leading to poor weight gain and reduced vigour. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ffcf2a5e-c2b9-4217-8a60-38c789da6b88/documents/81e6e5b6-9bb1-4a12-bbc9-42cfb2306abd_24e6e5ce-b12f-4b10-bcfa-a287eb635c90.html,,,,,, "2-Propenenitrile, polymer with 1,2-ethanediamine",28183-82-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ffcf2a5e-c2b9-4217-8a60-38c789da6b88/documents/81e6e5b6-9bb1-4a12-bbc9-42cfb2306abd_24e6e5ce-b12f-4b10-bcfa-a287eb635c90.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,700 mg/kg bw/day,,mouse "2-Propenenitrile, reaction products with 1,3-benzenedimethanamine",90530-16-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The reliability of the predictions is not high due to the lack of sufficient RDT data for the UVCB and its constituents and a scarcity of analogues with available experimental data. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f03ddfb-824d-4b4d-912a-4e592adb46f9/documents/IUC5-51785ac1-a058-4dc7-b545-e6c939b85d98_d9d0b4aa-a86a-44de-ab80-bd24853dc80c.html,,,,,, "2-Propenenitrile, reaction products with 1,3-benzenedimethanamine",90530-16-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f03ddfb-824d-4b4d-912a-4e592adb46f9/documents/IUC5-51785ac1-a058-4dc7-b545-e6c939b85d98_d9d0b4aa-a86a-44de-ab80-bd24853dc80c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "2-Propenenitrile, reaction products with 1,3-benzenedimethanamine",90530-16-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): QSAR prediction Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): read-across category approach prediction ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f03ddfb-824d-4b4d-912a-4e592adb46f9/documents/IUC5-840a7d6a-b650-4226-8507-606c428e1362_d9d0b4aa-a86a-44de-ab80-bd24853dc80c.html,,,,,, "2-Propenenitrile, reaction products with 1,3-benzenedimethanamine",90530-16-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f03ddfb-824d-4b4d-912a-4e592adb46f9/documents/IUC5-840a7d6a-b650-4226-8507-606c428e1362_d9d0b4aa-a86a-44de-ab80-bd24853dc80c.html,,oral,LD50,917 mg/kg bw,adverse effect observed, "2-Propenenitrile, reaction products with 1,3-benzenedimethanamine",90530-16-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f03ddfb-824d-4b4d-912a-4e592adb46f9/documents/IUC5-840a7d6a-b650-4226-8507-606c428e1362_d9d0b4aa-a86a-44de-ab80-bd24853dc80c.html,,dermal,LD50,"1,492.53 mg/kg bw",adverse effect observed, "2-Propenenitrile, reaction products with 1,3-benzenedimethanamine",90530-16-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f03ddfb-824d-4b4d-912a-4e592adb46f9/documents/IUC5-840a7d6a-b650-4226-8507-606c428e1362_d9d0b4aa-a86a-44de-ab80-bd24853dc80c.html,,inhalation,LC50,"1,850 mg/m3",adverse effect observed, "2-Propenenitrile, reaction products with 2,2,4(or 2,4,4)-trimethyl-1,6-hexanediamine",90530-20-4," Under the conditions of the present study, CeTePox® 0214 H caused reduced body weight and body weight gain, reduced food consumption in parental male and female Han:WIST rats at 100 mg/kg bw/day administered by oral gavage. In male animals at 100 mg/kg bw/day, test item influence on hepatic function was detected in clinical chemistry parameters, in necropsy findings and histopathological findings (centrilobular vacuolation in the hepatocytes). At 100 mg/kg bw/day, the delivery data of dams (mean number of implantation sites and lower mean birth (total birth, live born and viable pups per litter) was slightly depressed. There were no test item related changes in male or female animals at 10 or 30 mg/kg bw/day. The development of the F1 offspring was not impaired at any dose level from birth to post-natal day 13 after repeated oral administration of dams. Based on these observations the No Observed Adverse Effect Level (NOAEL) was determined as follows: NOAEL for systemic toxicity of male/female rats: 30 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0bebceeb-41bb-40d4-9dd2-ba2e7c7a6f40/documents/1a6a61ba-da50-4c04-a118-71fbaecf0226_0d50ce87-9808-42b6-a602-4027757ab60d.html,,,,,, "2-Propenenitrile, reaction products with 2,2,4(or 2,4,4)-trimethyl-1,6-hexanediamine",90530-20-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0bebceeb-41bb-40d4-9dd2-ba2e7c7a6f40/documents/1a6a61ba-da50-4c04-a118-71fbaecf0226_0d50ce87-9808-42b6-a602-4027757ab60d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "2-Propenenitrile, reaction products with 2,2,4(or 2,4,4)-trimethyl-1,6-hexanediamine",90530-20-4," Oral: In an acute oral toxicity study in rats similar to OECD guideline 401, an oral LD50 of 640 mg/kg bw was determined. No studies on acute dermal or inhalative toxicity were performed, since the test item is classified as skin corrosive (UN GHS H314). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0bebceeb-41bb-40d4-9dd2-ba2e7c7a6f40/documents/6dcadd23-500e-48b3-9b06-1d3ffdff2464_0d50ce87-9808-42b6-a602-4027757ab60d.html,,,,,, "2-Propenenitrile, reaction products with 2,2,4(or 2,4,4)-trimethyl-1,6-hexanediamine",90530-20-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0bebceeb-41bb-40d4-9dd2-ba2e7c7a6f40/documents/6dcadd23-500e-48b3-9b06-1d3ffdff2464_0d50ce87-9808-42b6-a602-4027757ab60d.html,,oral,LD50,640 mg/kg bw,adverse effect observed, "2-Propenenitrile, reaction products with 3-amino-1,5,5-trimethylcyclohexanemethanamine",90530-15-7, The NOAEL for the test substance is considered to be 100 mg/kg bw/day for females and 30 mg/kg bw/day for males. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d24f299a-197a-4ae3-b875-be4e75a87084/documents/8ef737de-f0d1-4435-b352-e01544606d9b_2402afab-ed6c-41c9-9053-656f18cc69e9.html,,,,,, "2-Propenenitrile, reaction products with 3-amino-1,5,5-trimethylcyclohexanemethanamine",90530-15-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d24f299a-197a-4ae3-b875-be4e75a87084/documents/8ef737de-f0d1-4435-b352-e01544606d9b_2402afab-ed6c-41c9-9053-656f18cc69e9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "2-Propenenitrile, reaction products with 3-amino-1,5,5-trimethylcyclohexanemethanamine",90530-15-7,"The test substance is considered to be of low acute oral toxicity with LD50 value 2,600 mg/kg bw . ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d24f299a-197a-4ae3-b875-be4e75a87084/documents/076ca656-71d3-4ee9-ba80-f2a125f2803c_2402afab-ed6c-41c9-9053-656f18cc69e9.html,,,,,, "2-Propenenitrile, reaction products with 3-amino-1,5,5-trimethylcyclohexanemethanamine",90530-15-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d24f299a-197a-4ae3-b875-be4e75a87084/documents/076ca656-71d3-4ee9-ba80-f2a125f2803c_2402afab-ed6c-41c9-9053-656f18cc69e9.html,,oral,LD50,"2,600 mg/kg bw",no adverse effect observed, "2-Propenenitrile, reaction products with ethylenediamine, hydrogenated",68909-99-9,No data available. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55c6cdcd-9bf1-4c9b-807c-d5e70e5bbaf6/documents/IUC5-1c55b5c0-5e06-46c1-bc19-830341ccf826_dd4085bf-9f12-4ebf-8d67-b31f88aece80.html,,,,,, "2-Propenenitrile, reaction products with ethylenediamine, hydrogenated",68909-99-9,"No acute toxicity studies of registered substance were available. The registered substance is a complex reaction mixture, containing N,N'-bis(3-aminopropyl)ethylenediamine (CAS No. 10563-26-5) and N-(2-aminoethyl)-1,3-propanediamine (CAS No. 13531-52-7) among others as majors components. These two components were used as surrogate to evaluate the toxicity of the registered substance. For further justification please refer to IUCLID chapter 13. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55c6cdcd-9bf1-4c9b-807c-d5e70e5bbaf6/documents/IUC5-7d1ffd2b-4c83-4ae6-8500-863e53f559c5_dd4085bf-9f12-4ebf-8d67-b31f88aece80.html,,,,,, "2-Propenenitrile, reaction products with ethylenediamine, hydrogenated",68909-99-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55c6cdcd-9bf1-4c9b-807c-d5e70e5bbaf6/documents/IUC5-7d1ffd2b-4c83-4ae6-8500-863e53f559c5_dd4085bf-9f12-4ebf-8d67-b31f88aece80.html,,oral,LD50,"1,140 mg/kg bw",adverse effect observed, "2-Propenenitrile, reaction products with ethylenediamine, hydrogenated",68909-99-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55c6cdcd-9bf1-4c9b-807c-d5e70e5bbaf6/documents/IUC5-7d1ffd2b-4c83-4ae6-8500-863e53f559c5_dd4085bf-9f12-4ebf-8d67-b31f88aece80.html,,dermal,LD50,184 mg/kg bw,adverse effect observed, "2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine",111497-86-0,"Based on the changes in liver weights, histopathology and clinical chemistry findings recorded in males at 1000 mg/kg bw/day in a 90-day study, the NOAEL for systemic toxicity in males was established at 300 mg/kg bw/day. No statistically significant adverse effects were noted in females in the same study or in an OECD 422 study available with the substance up to 1000 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91bcf7c3-2c38-4050-992b-acd9728e8311/documents/IUC5-ab6f9c65-1cd4-4da1-8156-7a40c472bdd7_eeb004db-8c38-42d9-9981-781683452397.html,,,,,, "2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine",111497-86-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91bcf7c3-2c38-4050-992b-acd9728e8311/documents/IUC5-ab6f9c65-1cd4-4da1-8156-7a40c472bdd7_eeb004db-8c38-42d9-9981-781683452397.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine",111497-86-0,"Based on the results from acute oral and dermal toxicity studies, amine synergist is considered to have a low acute toxicity potential via the oral and dermal routes. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91bcf7c3-2c38-4050-992b-acd9728e8311/documents/IUC5-75a1070e-d817-4162-aa62-113040736920_eeb004db-8c38-42d9-9981-781683452397.html,,,,,, "2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine",111497-86-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91bcf7c3-2c38-4050-992b-acd9728e8311/documents/IUC5-75a1070e-d817-4162-aa62-113040736920_eeb004db-8c38-42d9-9981-781683452397.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Propenoic acid, (1-methyl-1,2-ethanediyl) bis[oxy(methyl-2,1-ethanediyl)] ester, reaction products with diethylamine",111497-86-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91bcf7c3-2c38-4050-992b-acd9728e8311/documents/IUC5-75a1070e-d817-4162-aa62-113040736920_eeb004db-8c38-42d9-9981-781683452397.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "(2,2-dimethyl-1,3-dioxolan-4-yl) methyl prop-2-enoate",13188-82-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): guideline study ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9317b351-b576-45a4-b105-9af1b878b1f4/documents/fbdf8de2-5017-4f74-accf-174d11e6bb08_38f51a8b-f7cd-4c8b-90d7-c7e52071da06.html,,,,,, "(2,2-dimethyl-1,3-dioxolan-4-yl) methyl prop-2-enoate",13188-82-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9317b351-b576-45a4-b105-9af1b878b1f4/documents/fbdf8de2-5017-4f74-accf-174d11e6bb08_38f51a8b-f7cd-4c8b-90d7-c7e52071da06.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "(2,2-dimethyl-1,3-dioxolan-4-yl) methyl prop-2-enoate",13188-82-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9317b351-b576-45a4-b105-9af1b878b1f4/documents/74e1d5b3-252f-4d96-a5f6-ba8f93bb5918_38f51a8b-f7cd-4c8b-90d7-c7e52071da06.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, "(2,2-dimethyl-1,3-dioxolan-4-yl) methyl prop-2-enoate",13188-82-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9317b351-b576-45a4-b105-9af1b878b1f4/documents/74e1d5b3-252f-4d96-a5f6-ba8f93bb5918_38f51a8b-f7cd-4c8b-90d7-c7e52071da06.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-[2-[1-[2-[[2-(9-oxothioxanthen-2-yl)oxyacetyl]amino]-3-[1-[2-(2-prop-2-enoyloxyethoxy)ethoxy]ethoxy]-2-[1-[2-(2-prop-2-enoyloxyethoxy)ethoxy]ethoxymethyl]propoxy]ethoxy]ethoxy]ethyl prop-2-enoate,1427388-03-1,"  The substance (CAS 1427388 -03 -1) can be structurally divided into a 'body' and three 'arms'. The three 'arms' are identified as 2-(2 -Vinyloxyethoxy)ethyl acrylate (VEEA - CAS: 86273 -46 -3) and is registered between 10 -100 tonnes/year. The body is identified as Omnipol TX but has no reliable, useful experimental data. Read-across to VEEA is proposed, in combination with QSAR estimation for the full substance. VEEA is classified as Acute Toxic Cat. 4 - oral route. Based on QSAR the full substance (CAS 1427388 -03 -1) would not be classified. However following the precautionary principle, the full substance will be classified as Acute Toxic Cat. 4 - oral route. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1134fd42-dce1-4902-b909-52b5d2df4814/documents/IUC5-58f5f84f-efab-4a62-a551-88b7cd0eb71d_c72003e8-73ad-40ae-91d2-ee2954b1bdc2.html,,,,,, 2-[2-[1-[2-[[2-(9-oxothioxanthen-2-yl)oxyacetyl]amino]-3-[1-[2-(2-prop-2-enoyloxyethoxy)ethoxy]ethoxy]-2-[1-[2-(2-prop-2-enoyloxyethoxy)ethoxy]ethoxymethyl]propoxy]ethoxy]ethoxy]ethyl prop-2-enoate,1427388-03-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1134fd42-dce1-4902-b909-52b5d2df4814/documents/IUC5-58f5f84f-efab-4a62-a551-88b7cd0eb71d_c72003e8-73ad-40ae-91d2-ee2954b1bdc2.html,,oral,LD50,>=300 mg/kg bw,adverse effect observed, "2-Propenoic acid, 2-[[1,1,2-trifluoro-2-(1,1,2,2,3,3,3-heptafluoropropoxy)ethyl]thio]ethyl ester",2170099-74-6,The test item is not acutely toxic via the oral route (reference 7.2.1-1). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9205825f-8fe6-4e11-a6e7-67abfad71be4/documents/c39c9ce5-de4f-43ef-a900-e5a68370d111_335914c1-47b7-4833-b57d-1985e9a4393c.html,,,,,, "2-Propenoic acid, 2-[[1,1,2-trifluoro-2-(1,1,2,2,3,3,3-heptafluoropropoxy)ethyl]thio]ethyl ester",2170099-74-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9205825f-8fe6-4e11-a6e7-67abfad71be4/documents/c39c9ce5-de4f-43ef-a900-e5a68370d111_335914c1-47b7-4833-b57d-1985e9a4393c.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-(2-Vinyloxyethoxy)ethyl acrylate,86273-46-3," Key study: 90 -day oral toxicity (OECD 408): In males and females in the 400 mg/kg group, changes attributable to the local irritation to the first exposure site were noted. The other changes observed in this group were only minor changes that may possibly be associated with inflammation. Therefore, the no-observed-adverse-effect level of VEEA was considered 40 mg/kg based on the local effects observed in both males and females under the present study conditions. No specific target organ toxicity was observed in either sex up to the dose level of 400 mg/kg. 28-day oral toxicity (OECD 407): 50 mg/kg body weight/day  was established as the no-observed-effect-level (NOEL) and 160 mg/kg body weight/day  as the no-observed adverse- effect-level (NOAEL). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06e60dfd-6d35-49fd-8206-c5b5e8b93fb1/documents/IUC5-12194585-978f-4fcf-8418-3a292453499d_7ca4907d-f735-40c1-aa75-1951754929e2.html,,,,,, 2-(2-Vinyloxyethoxy)ethyl acrylate,86273-46-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06e60dfd-6d35-49fd-8206-c5b5e8b93fb1/documents/IUC5-12194585-978f-4fcf-8418-3a292453499d_7ca4907d-f735-40c1-aa75-1951754929e2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat 2-(2-Vinyloxyethoxy)ethyl acrylate,86273-46-3, Two Acute oral studies have been undertaken. The results of both studies classify the substance as harmful if swallowed. The key study was chosen as it follows an OECD guideline and was conducted to GLP. In an acute inhalation study the 4 hr LC50 in rats was greater than 5.82 mg/L. In an acute dermal study the LD50 was greater than 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06e60dfd-6d35-49fd-8206-c5b5e8b93fb1/documents/IUC5-b9f5a460-3033-4ff0-ad3d-008bc81846da_7ca4907d-f735-40c1-aa75-1951754929e2.html,,,,,, 2-(2-Vinyloxyethoxy)ethyl acrylate,86273-46-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06e60dfd-6d35-49fd-8206-c5b5e8b93fb1/documents/IUC5-b9f5a460-3033-4ff0-ad3d-008bc81846da_7ca4907d-f735-40c1-aa75-1951754929e2.html,,oral,LD50,300 mg/kg bw,adverse effect observed, 2-(2-Vinyloxyethoxy)ethyl acrylate,86273-46-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06e60dfd-6d35-49fd-8206-c5b5e8b93fb1/documents/IUC5-b9f5a460-3033-4ff0-ad3d-008bc81846da_7ca4907d-f735-40c1-aa75-1951754929e2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-(2-Vinyloxyethoxy)ethyl acrylate,86273-46-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06e60dfd-6d35-49fd-8206-c5b5e8b93fb1/documents/IUC5-b9f5a460-3033-4ff0-ad3d-008bc81846da_7ca4907d-f735-40c1-aa75-1951754929e2.html,,inhalation,LC50,"5,820 mg/m3",no adverse effect observed, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-chloroacrylate",96383-55-0,In a subacute study in rats main test substance-related changes were degeneration/necrosis in the myocardial cell and in myocardial cell around the vein in both sexes of the 40 mg/kg bw/d group. Therefore the NOAEL is 10 mg/kg bw/d under the conditions of the study. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c52b3677-0be4-417b-960e-64bcf37241a8/documents/IUC5-94e66d0e-fe2d-4099-b71d-b57a50bfea03_3fdfa043-e5e2-4486-b4d2-12e16cbc7db3.html,,,,,, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-chloroacrylate",96383-55-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c52b3677-0be4-417b-960e-64bcf37241a8/documents/IUC5-94e66d0e-fe2d-4099-b71d-b57a50bfea03_3fdfa043-e5e2-4486-b4d2-12e16cbc7db3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-chloroacrylate",96383-55-0,"Oral (OECD 423), female rat: LD50 >300 and <2000 mg/kg bwDermal (OECD 402), rat: LD50 > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c52b3677-0be4-417b-960e-64bcf37241a8/documents/IUC5-99b32716-1f99-4931-ae18-e0f24eafd89d_3fdfa043-e5e2-4486-b4d2-12e16cbc7db3.html,,,,,, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-chloroacrylate",96383-55-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c52b3677-0be4-417b-960e-64bcf37241a8/documents/IUC5-99b32716-1f99-4931-ae18-e0f24eafd89d_3fdfa043-e5e2-4486-b4d2-12e16cbc7db3.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl 2-chloroacrylate",96383-55-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c52b3677-0be4-417b-960e-64bcf37241a8/documents/IUC5-99b32716-1f99-4931-ae18-e0f24eafd89d_3fdfa043-e5e2-4486-b4d2-12e16cbc7db3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl 2-fluoroprop-2-enoate,2343-89-7," The substance was tested in a reliable OECD 422 study using dose levels of 0.75, 1.5 and 3 mg/kg/day. The main study demonstrated no adverse effects at any dose level and no target organ was identified. The NOEL is 3 mg/kg/day. The dose selection for the main study was based on a 14 day range finding study. In the study dose levels of 0, 3, 5 and 10 mg/kg/day were used which resulted in a reduction in overall mean body weight gain in all treated dose groups. Based on these results, dose levels of 10 or 5 mg/kg bw/day were considered to be too high for repeat dosing in an OECD 422 study. A dose level of 3 mg/kg bw/day was considered to be suitable as the high dose level for the main OECD 422 study. The requirement for the 90 day subchronic study is waived in accordance with REACH Annex XI, 3.2.(b). The substance is not incorporated in an article and for all relevant scenarios throughout the life cycle is used under strictly controlled conditions. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a8e6f21-beda-49dc-92b6-4744c720f273/documents/IUC5-e7db3d74-3650-4e16-bb98-2e2b1430e65c_e1bd9092-a6a9-448b-8c01-f3abfa05b694.html,,,,,, Methyl 2-fluoroprop-2-enoate,2343-89-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a8e6f21-beda-49dc-92b6-4744c720f273/documents/IUC5-e7db3d74-3650-4e16-bb98-2e2b1430e65c_e1bd9092-a6a9-448b-8c01-f3abfa05b694.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,3 mg/kg bw/day,,rat Methyl 2-fluoroprop-2-enoate,2343-89-7," In recently conducted, reliable, guideline studies, the substance showed moderate acute toxicity to Wistar rats by the oral dose route (LD50 = 50 - 300 mg/kg) and low acute toxicity by the dermal dose route (LD50 >2000 mg/kg). Testing by the inhalation route was not justified based on the likely use and exposure. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a8e6f21-beda-49dc-92b6-4744c720f273/documents/IUC5-00efd774-792c-4a86-b3bb-e658c429365a_e1bd9092-a6a9-448b-8c01-f3abfa05b694.html,,,,,, Methyl 2-fluoroprop-2-enoate,2343-89-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a8e6f21-beda-49dc-92b6-4744c720f273/documents/IUC5-00efd774-792c-4a86-b3bb-e658c429365a_e1bd9092-a6a9-448b-8c01-f3abfa05b694.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Methyl 2-fluoroprop-2-enoate,2343-89-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a8e6f21-beda-49dc-92b6-4744c720f273/documents/IUC5-00efd774-792c-4a86-b3bb-e658c429365a_e1bd9092-a6a9-448b-8c01-f3abfa05b694.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-(4-benzoyl-3-hydroxyphenoxy)ethyl (2-methyl)-2-propenoat,16613-04-0,One acute oral study (limit test) according to OECD guideline 401 in compliance with GLP is available. Substance related effects were not observed. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58d1bc2f-6c38-4d8e-bec8-226e21bb103d/documents/IUC5-37bf8bb6-2d34-4ee3-acd5-dbb7e7e5c6c9_a1ae69ee-e3a9-4fcf-ac32-d0cc826bbcfd.html,,,,,, "2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with phosphorus oxide",1187441-10-6, The NOAEL of 300 mg/kg bw/day (based on liver and kidney changes) has been considered further for hazard assessment. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b1679f2-a1f8-4f01-957e-3bfac07965aa/documents/cb86cef3-0daf-4ccd-813f-2b02db4f3b6c_876f2246-4583-472d-b7d5-d6ce2ee8d75b.html,,,,,, "2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with phosphorus oxide",1187441-10-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b1679f2-a1f8-4f01-957e-3bfac07965aa/documents/cb86cef3-0daf-4ccd-813f-2b02db4f3b6c_876f2246-4583-472d-b7d5-d6ce2ee8d75b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with phosphorus oxide",1187441-10-6," The oral LD50 of the test substance was determined to be ≥2,000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b1679f2-a1f8-4f01-957e-3bfac07965aa/documents/bb92076f-a74c-4c4f-823b-c093480904c6_876f2246-4583-472d-b7d5-d6ce2ee8d75b.html,,,,,, "2-Propenoic acid, 2-methyl-, 2-hydroxyethyl ester, reaction products with phosphorus oxide",1187441-10-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b1679f2-a1f8-4f01-957e-3bfac07965aa/documents/bb92076f-a74c-4c4f-823b-c093480904c6_876f2246-4583-472d-b7d5-d6ce2ee8d75b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-propenoic acid, 2-methyl-, 4-benzoylphenyl ester",56467-43-7," In a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test according to OECD Guideline 422 (28 July 2015) 4-{Methacryloyloxy)benzophenone was administered to 10 Hsd: Sprague Dawley SD rats/sex/dose orally by gavage at dose levels of 0 (control), 100, 300 and 1000 mg/kg bw/d. The treatment schedule included 2 weeks before pairing, during pairing, post coitum and post partum periods up to day 3 post partum. Animals were administered for approximately 5 and 8 weeks for males and females, respectively.    The purpose of this study was to generate information concerning toxic effects on SpragueDawley rats of both sexes after repeated oral dosing with 4-(Methacryloyloxy)benzophenone,as well as any effects of the test item on male and female reproductive performance, such asgonadal function, conception, parturition and lactation of offspring. The dose levels usedduring the study were 70, 200 and 600 mg/kg/day. Males One control male was sacrificed on Day 14 of the study for poor health condition. On thebasis of the macroscopic and microscopic findings, the factor contributory to the death wasmainly attributed to a misdosing. Males were treated for 2 weeks prior to pairing and during pairing with females until the daybefore necropsy, for a total of 48 days. During thein-lifephase, mortality check, clinical signs (including neurotoxicity assessment,motor activity and sensory reaction tostimuli), body weight, body weight gain, food consumptionand mating performance were evaluated. Clinical pathology investigations (haematology, clinical chemistry, urinalysis), organ weights,macroscopic observations and histopathological examination were also performed. In addition, thyroid hormone levels were determined in all adult males. The histopathologicalexamination was performed only on control and high dose groups (5 animals/sex/grouprandomly selected). It included identification of the stages of the spermatogenic cycle in the same five control and high dose males. No relevant signs of toxicological significance were observed in treated males, apart from atransient salivation, observed for a few days in the high dose animals. Body weights and food consumption did not show any treatment related effects. Fertilityindex and copulatory index were unaffected by treatment. No effects considered treatmentrelated were observed in haematology or coagulation, clinical chemistry and urinalysis. Hormone analysis did not showany relation to treatment. Some fluctuations in organweights,absolute and/or relative, were noted, but in the absence of histopathological correlated findings, these changes were considered of no toxicological significance. Females Females were treated for 2weeks prior to pairing, during pairing and throughout the gestationand lactation periods until Day 12post partum. During thein-lifephase, mortality check, clinical signs (including neurotoxicity assessment,motor activity and sensory reaction tostimuli), body weight, body weight gain, food consumption and mating performance were evaluated. Clinical pathology investigations(haematology and clinical chemistry) and thyroid hormone determination in pups on Day 13post partumwere also evaluated. The histopathological examination was carried out in five females of control and high dose groups, selected randomly. Clinical signs of pups, as well asnecropsy examination of decedent pups or pups sacrificed on Days 4 and 13post partum(including thyroid weight) were recorded. Litter data, sex ratios and gestation length were recorded. No relevant signs of toxicological significance were observed. As noted for males, salivationwas recorded occasionally in treated females receiving 600 mg/kg/day. Body weights andfood consumption did not show changes of toxicological significance. Concerning the reproductive parameters, no relevant differences were found in terms ofmating performance including the pre-coital interval (number of days paired to spermpositive day) and the copulatory evidence (the positive identification of mating i.e. the presence of spermand/or copulation plugin situor in the cage), as well as fertility index. The slight changes noted at clinical chemistry investigation (haematology, clinical chemistryand coagulation) were not considered treatment related. Some fluctuations in organ weights,absolute and/or relative, were noted but in the absence of histopathological correlated findings, these changes were considered of no toxicological significance. Conclusion Based on the results of the present study, the NOAEL (No Observed Adverse Effect Level) forgeneral toxicity and for reproductive and developmental toxicity was considered to be 600mg/kg/day both for males and females. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/254a0648-c000-4f88-ac23-1c3bda2832d2/documents/a6215876-8eae-4149-9295-aee19b6f6ea3_dcc52fae-8e74-4c47-918a-7c569ec69bb3.html,,,,,, "2-propenoic acid, 2-methyl-, 4-benzoylphenyl ester",56467-43-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/254a0648-c000-4f88-ac23-1c3bda2832d2/documents/a6215876-8eae-4149-9295-aee19b6f6ea3_dcc52fae-8e74-4c47-918a-7c569ec69bb3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat "2-propenoic acid, 2-methyl-, 4-benzoylphenyl ester",56467-43-7," Under the conditions of the present study, single oral application of the test item 4-(Methacryloyloxy)benzophenone to rats at a dose of 2000 mg/kg body weight was associated with slight to severe signs of toxicity but no mortality. The median lethal dose of 4-(Methacryloyloxy)benzophenone after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut off (rat): 5000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/254a0648-c000-4f88-ac23-1c3bda2832d2/documents/cb47e4ef-6216-4e62-83f4-501720b44523_dcc52fae-8e74-4c47-918a-7c569ec69bb3.html,,,,,, "2-propenoic acid, 2-methyl-, 4-benzoylphenyl ester",56467-43-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/254a0648-c000-4f88-ac23-1c3bda2832d2/documents/cb47e4ef-6216-4e62-83f4-501720b44523_dcc52fae-8e74-4c47-918a-7c569ec69bb3.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 7-oxabicyclo[4.1.0]hept-3-ylmethyl 2-methylprop-2-enoate,82428-30-6,LD50 = 2500 mg/kg bw | rat (male/female) | OECD 423 | ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1df9717-0e70-453d-a8bc-3a180be959b8/documents/IUC5-82fc35e6-e546-400e-afd1-9e777242d1de_991984e1-f7f8-4506-bff9-31bc8379c425.html,,,,,, 7-oxabicyclo[4.1.0]hept-3-ylmethyl 2-methylprop-2-enoate,82428-30-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1df9717-0e70-453d-a8bc-3a180be959b8/documents/IUC5-82fc35e6-e546-400e-afd1-9e777242d1de_991984e1-f7f8-4506-bff9-31bc8379c425.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, "2-Propenoic acid, 2-methyl-, C11-14-isoalkyl esters, C13-rich",85736-97-6," NOAEL = 120 mg/kg bw/d, subchronic (OECD TG 408; rat, oral gavage; RL1, GLP): general (unspecific) systemic toxicity in male as well as female rats at a dose level of 360 mg/kg bw/day (body weight, clinical chemistry); read-across from 2-Ethylhexyl methacrylate ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58e4556e-e5df-45d4-97b8-b95394d51fa9/documents/dcb51007-0e16-458a-9f67-a3aaaf041c93_ab460a6e-e4f4-4228-bff4-dee71f1cf06c.html,,,,,, "2-Propenoic acid, 2-methyl-, C11-14-isoalkyl esters, C13-rich",85736-97-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58e4556e-e5df-45d4-97b8-b95394d51fa9/documents/dcb51007-0e16-458a-9f67-a3aaaf041c93_ab460a6e-e4f4-4228-bff4-dee71f1cf06c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat "2-Propenoic acid, 2-methyl-, C11-14-isoalkyl esters, C13-rich",85736-97-6," Acute oral toxicity: LD50 (rat, male/female) > 5000 mg/kg bw (OECD TG 401; GLP, RL1) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58e4556e-e5df-45d4-97b8-b95394d51fa9/documents/bfd22653-4d49-4f46-adb7-2173eb6f51f7_ab460a6e-e4f4-4228-bff4-dee71f1cf06c.html,,,,,, "2-Propenoic acid, 2-methyl-, C12-15-branched and linear alkyl esters",90552-02-6,"In a well-conducted OECD combined repeated dose and reproductive/developmental toxicity screening test (OECD TG 422) by oral gavage in rats no toxicity occurred up to the highest administered dose of 1000 mg/kg/day. The NOAEL was determined to 1000 mg/kg/day.With regard to the low repeated dose oral toxicity and the characteristics of skin penetration and metabolism in the skin, the repeated dose dermal toxicity can be considered as low. The inhalation route is not of relevance due to the very low vapour pressure of the substances. Taken as a whole there are sufficient data available for the long-chain alkyl methacrylate esters for assessment purposes so for the sake of animal welfare it is not proposed to conduct further repeated dose studies. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8d206e3-aad2-4a8e-98a8-00b2bd8561f8/documents/IUC5-40434eba-7eff-49da-b881-925fe511236a_d936d7aa-cc18-44a7-a540-8dad16ebf2b5.html,,,,,, "2-Propenoic acid, 2-methyl-, C12-15-branched and linear alkyl esters",90552-02-6,The acute toxicity of the long-chain alkyl methacrylate esters (C12 – C22) can be considered as very low by the oral and dermal route. The inhalation route is not of relevance due to the very low vapour pressure of the substances. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8d206e3-aad2-4a8e-98a8-00b2bd8561f8/documents/IUC5-2335326d-dadd-4e2f-b4e8-d47218089d6a_d936d7aa-cc18-44a7-a540-8dad16ebf2b5.html,,,,,, "2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters",90552-04-8,"No data are available for 2-Propenoic acid, 2-methyl-, C13-C15-branched and linear alkyl esters, but for the read-across substance Dodecy methacrylate CAS 142-90-5). OECD 422 NOAEL = 1000 mg/kg bw/d (CIT, 2007). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Relaible witout restriction (Klimisch score: 1) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7014a2ad-ab8d-4540-a8fb-5e4ea44ecc37/documents/b8ca5310-d9ad-417a-bd21-5d7e55f896f1_0500791a-0821-4b19-8a92-401e9bf80408.html,,,,,, "2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters",90552-04-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7014a2ad-ab8d-4540-a8fb-5e4ea44ecc37/documents/b8ca5310-d9ad-417a-bd21-5d7e55f896f1_0500791a-0821-4b19-8a92-401e9bf80408.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters",90552-04-8, LD50 oral (rat): > 5000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7014a2ad-ab8d-4540-a8fb-5e4ea44ecc37/documents/f5d883d8-4f36-4c7f-91dc-c74085d85eee_0500791a-0821-4b19-8a92-401e9bf80408.html,,,,,, "2-Propenoic acid, 2-methyl-, C13-15-branched and linear alkyl esters",90552-04-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7014a2ad-ab8d-4540-a8fb-5e4ea44ecc37/documents/f5d883d8-4f36-4c7f-91dc-c74085d85eee_0500791a-0821-4b19-8a92-401e9bf80408.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "2-Propenoic acid, 2-methyl-, C6-12-alkyl esters",90530-40-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49c0af8b-00e7-44ff-a11c-fd59d854628f/documents/1a2acdcb-a9cf-44c4-b256-68255c2130f5_d2b64913-82fe-4535-bb7a-aca35fdf0519.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-Propenoic acid, 2-methyl-, heptadecyl ester, branched",1473386-29-6,"Subacute study; oral (gavage); rat (Sprague Dawley SD), m/f (OECD guideline 422, Klimisch score: 1,GLP), no toxicity occurred up to the highest administered dose of 1000 mg/kg bw/day with Dodecyl methacrylate: NOAEL = 1000 mg/kg bw/day (CIT, 2007). ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/69ed197f-5e11-4cf5-96a7-2bbff3be6518/documents/IUC5-4734bea4-2c75-45f4-a8f4-c0c16270f315_2555e9ae-b781-40ec-84a9-654dd7b2c91f.html,,,,,, "2-Propenoic acid, 2-methyl-, heptadecyl ester, branched",1473386-29-6,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/69ed197f-5e11-4cf5-96a7-2bbff3be6518/documents/IUC5-4734bea4-2c75-45f4-a8f4-c0c16270f315_2555e9ae-b781-40ec-84a9-654dd7b2c91f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-Propenoic acid, 2-methyl-, heptadecyl ester, branched",1473386-29-6,"LD50(rat) oral: > 2000 mg/kg bw (BASF, 2014)LD50(rat) dermal: > 5000 mg/kg bw (BASF, 2014) ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69ed197f-5e11-4cf5-96a7-2bbff3be6518/documents/IUC5-8343d7ae-89fe-4823-ac86-1b6d163c8ba7_2555e9ae-b781-40ec-84a9-654dd7b2c91f.html,,,,,, "2-Propenoic acid, 2-methyl-, heptadecyl ester, branched",1473386-29-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69ed197f-5e11-4cf5-96a7-2bbff3be6518/documents/IUC5-8343d7ae-89fe-4823-ac86-1b6d163c8ba7_2555e9ae-b781-40ec-84a9-654dd7b2c91f.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-Propenoic acid, 2-methyl-, heptadecyl ester, branched",1473386-29-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69ed197f-5e11-4cf5-96a7-2bbff3be6518/documents/IUC5-8343d7ae-89fe-4823-ac86-1b6d163c8ba7_2555e9ae-b781-40ec-84a9-654dd7b2c91f.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2-Propenoic acid, 2-methyl-, tetracosyl ester, branched",90552-24-2," A GLP compliant study assessing the potential toxic effects of 2- Propenoic acid, 2-methyl-, tetracosyl ester (branched) henceforth referred to as “test item” was conducted using the OECD guideline 422: Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test method. The test item was administered to three groups of 10 male and 10 female Sprague-Dawley rats, daily, by the oral route (gavage) at dose levels of 100, 300 or 1,000 mg/kg bw/day, using a constant dosing volume of 5ml/kg/day. Males were treated for an overall period of at least 4 weeks (2 weeks before mating, during the mating period and until the day before euthanasia). Females were treated for an overall period of 8 to 9 weeks (2 weeks before mating, throughout mating (up to 2 weeks) and gestation (3 weeks) until day 13 post-partum (p.p.) inclusive). A control group consisting of 10 male and 10 females received the vehicle (peanut oil) alone under the same experimental conditions. Concentrations of the test item in the dose formulations were determined using a validated Gas chromatography with flame ionisation detection analytical method in weeks 1, 3 and 6. Animals were observed daily during the treatment period for mortality, morbidity and clinical signs. No test item-related unscheduled deaths were noted. In relation to clinical signs, ptyalism occurred in one isolated male at 300 and 1,000 mg/kg bw/day and in one isolated female at 300 and 1,000 mg/kg bw/day during the gestation or the lactation period, respectively. This sign was not considered as an adverse effect as it is frequently detected when a test item is administered by gavage. Comprehensive clinical observations were conducted on a weekly basis. Body weights and food consumption were recorded weekly during the premating, mating, gestation and lactation periods (food consumption not recorded during mating period). No test-item related effects on mean body weight or body weight change at any dose level were noted. A Functional Observation Battery (FOB) was performed on five animals per sex and group at the end of the treatment period where no test item-related effects on FOB or motor activity data at any dose level were noted. Laboratory investigations (haematology and blood biochemistry) were carried out on designated males and females from each group at the end of the study. No test item-related effects on haematology parameters or blood chemistry at any dose level were noted. Plasma thyroid hormone levels (TSH and T4) were determined at termination in all males. No test item-related effects on T4 or TSH levels in males. The males were euthanized after completion of the mating period (i.e. after 30 days of treatment) and females were euthanized on Day 14 p.p. A full macroscopic post-mortem examination was performed on animals, with particular attention to the reproductive organs. Designated organs were weighed and selected tissue specimens were preserved. A microscopic examination was performed on selected tissues from five males and lactating females in the control and high-dose groups, in one group 3 female and one group 4 female that were prematurely euthanized and on all macroscopic lesions (all groups). The test item was not associated with any organ weights, macroscopic or microscopic changes. Under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) for systemic toxicity was found to be 1,000 mg/kg bw/day (high-dose level) in the absence of treatment-related adverse findings. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4ccbb1c-f350-41d9-9cde-3f5f51a8f7bb/documents/1eb8effc-7995-45eb-95bd-1cdbfce39f16_d4d87bc8-a610-4de9-9afb-9b0eae5d6372.html,,,,,, "2-Propenoic acid, 2-methyl-, tetracosyl ester, branched",90552-24-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4ccbb1c-f350-41d9-9cde-3f5f51a8f7bb/documents/1eb8effc-7995-45eb-95bd-1cdbfce39f16_d4d87bc8-a610-4de9-9afb-9b0eae5d6372.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-Propenoic acid, 2-methyl-, tetracosyl ester, branched",90552-24-2," The acute toxicity of 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) via the oral route was evaluated during a study performed according to the OECD Testing Guideline 420. The study was GLP-compliant. The fixed dose method was used. One female Wistar rat received by gavage a single dose of 300 mg/kg bw in arachis oil. In the absence of observable toxicity at 300 mg/kg bw, an animal was treated at 2,000 mg/kg bw (undiluted). Considering that no mortality or clear signs of toxicity were observed, four additional female Wistar rats were treated at 2,000 mg/kg bw. Following exposure to the test substance, animals were observed for 14 days. Clinical observations were made 30 minutes, 1, 2, and 4 hours after dosing and then daily until the end of the observation period. Morbidity and mortality checks were made twice daily, early and late during normal working days, and once daily at weekends and public holidays. Individual body weights were recorded on Day 0 (the day of dosing) and on Days 7 and 14. At the end of the observation period the animals were killed by cervical dislocation. All animals were subjected to gross necropsy. This consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance of any macroscopic abnormalities was recorded. No tissues were retained. No deaths occurred as a result to treatment. Hunched posture was noted in one animal during the day of dosing at 2,000 mg/kg bw. All animals showed expected gains in body weight over the observation period. No abnormalities were noted at necropsy. It can be concluded that2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) has a LD50 > 2,000 mg/kg bw via the oral route.    In accordance with Annex VIII of REACH, Column 2, testing via inhalation is only appropriate if exposure of humans is likely. Vapour pressure of 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) was investigated during a study performed in accordance with ASTM D2879 - 97 Standard Test Method for Vapour Pressure-Temperature Relationship and Initial Decomposition Temperature of Liquids by Isoteniscope, which concluded that the substance has a vapour pressure below 100 Pa. In addition formation of aerosols during the use of the substance is unlikely. It is therefore concluded that exposure to 2-Propenoic acid, 2-methyl-, tetracosyl ester(branched) is unlikely and that it is not appropriate to investigate this route exposure.   In accordance with Annex VIII of REACH, Column 2, testing by the dermal route does not need to be conducted since the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and the physiological properties of the substance suggest that it does not a potential for a significant rate of absorption through the skin (see Section 7.1).  ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4ccbb1c-f350-41d9-9cde-3f5f51a8f7bb/documents/4f6b6b17-1e91-4f9d-9889-029f89fd349e_d4d87bc8-a610-4de9-9afb-9b0eae5d6372.html,,,,,, "2-Propenoic acid, 2-methyl-, tetracosyl ester, branched",90552-24-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4ccbb1c-f350-41d9-9cde-3f5f51a8f7bb/documents/4f6b6b17-1e91-4f9d-9889-029f89fd349e_d4d87bc8-a610-4de9-9afb-9b0eae5d6372.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, tripropan-2-ylsilyl 2-methylprop-2-enoate,134652-60-1,Repeated dose toxicity summary ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d126517c-1e71-4b7b-b153-9d7eff179cc2/documents/IUC5-704d5702-83f2-42f1-9e37-4ee8b67039d7_3718b350-d3a8-4491-b6dd-2d3731c8aad4.html,,,,,, tripropan-2-ylsilyl 2-methylprop-2-enoate,134652-60-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d126517c-1e71-4b7b-b153-9d7eff179cc2/documents/IUC5-704d5702-83f2-42f1-9e37-4ee8b67039d7_3718b350-d3a8-4491-b6dd-2d3731c8aad4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat tripropan-2-ylsilyl 2-methylprop-2-enoate,134652-60-1,Summary of acute toxicity ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d126517c-1e71-4b7b-b153-9d7eff179cc2/documents/IUC5-1da8a1ae-6af4-40d4-9367-ace019cf5828_3718b350-d3a8-4491-b6dd-2d3731c8aad4.html,,,,,, tripropan-2-ylsilyl 2-methylprop-2-enoate,134652-60-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d126517c-1e71-4b7b-b153-9d7eff179cc2/documents/IUC5-1da8a1ae-6af4-40d4-9367-ace019cf5828_3718b350-d3a8-4491-b6dd-2d3731c8aad4.html,,oral,LD50,"2,500 mg/kg bw",, tripropan-2-ylsilyl 2-methylprop-2-enoate,134652-60-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d126517c-1e71-4b7b-b153-9d7eff179cc2/documents/IUC5-1da8a1ae-6af4-40d4-9367-ace019cf5828_3718b350-d3a8-4491-b6dd-2d3731c8aad4.html,,dermal,LD50,"2,000 mg/kg bw",, Acrylic acid 4-[[(4-benzoylphenoxy)carbonyl]oxy]butyl ester,131513-00-3,dermal:Under the conditions of the study the median lethal dose (LD50) of the test substance after dermal application was found to be greater than 2000 mg/kg bw in male and female rats.oral:Under the conditions of the study the range of mortality following a single oral administration was found to be greater than 2200 mg/kg bw for the male and female animals. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41442c53-9531-47a8-bd91-96f29861d93d/documents/IUC5-da698cf5-daac-4a53-b9b9-b0dc138d77dc_be606b21-c42c-4e6d-b03c-361e5acfd637.html,,,,,, Acrylic acid 4-[[(4-benzoylphenoxy)carbonyl]oxy]butyl ester,131513-00-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41442c53-9531-47a8-bd91-96f29861d93d/documents/IUC5-da698cf5-daac-4a53-b9b9-b0dc138d77dc_be606b21-c42c-4e6d-b03c-361e5acfd637.html,,oral,discriminating dose,"2,200 mg/kg bw",no adverse effect observed, Acrylic acid 4-[[(4-benzoylphenoxy)carbonyl]oxy]butyl ester,131513-00-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41442c53-9531-47a8-bd91-96f29861d93d/documents/IUC5-da698cf5-daac-4a53-b9b9-b0dc138d77dc_be606b21-c42c-4e6d-b03c-361e5acfd637.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-Propenoic acid, butyl ester, reaction products with butadiene, sulfur and tri-Ph phosphite",93925-37-2,"Oral administration of the test item to rats for a period of forty-two days for males and up to fifty-four days for females at dose levels of up to 1000 mg/kg/day resulted in treatment-related effects in males treated with 1000 and 350 mg/kg/day. No toxicologically significant effects were detected in females from any treatment groups. No clinically observable signs of toxicity were observed during the daily clinical observations and no toxicologically significant effects were observed during the weekly open field arena observations, the haematological parameters, or the blood chemical parameters. The effects detected in this study were considered not to represent an adverse health effect, therefore a NOAEL and a suitable high dose level for use on a twenty-eight day study was considered to be 1000 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4b6238c-0ae8-4ebf-a606-0c92fa389ebb/documents/IUC5-bd84e4c9-332c-45ef-95f1-1d9e7a2178d6_6d1626a5-efb7-45ca-98ba-b3af3cee699a.html,,,,,, "2-Propenoic acid, butyl ester, reaction products with butadiene, sulfur and tri-Ph phosphite",93925-37-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4b6238c-0ae8-4ebf-a606-0c92fa389ebb/documents/IUC5-bd84e4c9-332c-45ef-95f1-1d9e7a2178d6_6d1626a5-efb7-45ca-98ba-b3af3cee699a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-Propenoic acid, butyl ester, reaction products with butadiene, sulfur and tri-Ph phosphite",93925-37-2,oral (rat): LD50 > 5000 mg/kg bw (m+f) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4b6238c-0ae8-4ebf-a606-0c92fa389ebb/documents/IUC5-1a4afad1-d8aa-463e-9e21-f9f02ad6ad36_6d1626a5-efb7-45ca-98ba-b3af3cee699a.html,,,,,, "2-Propenoic acid, butyl ester, reaction products with butadiene, sulfur and tri-Ph phosphite",93925-37-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4b6238c-0ae8-4ebf-a606-0c92fa389ebb/documents/IUC5-1a4afad1-d8aa-463e-9e21-f9f02ad6ad36_6d1626a5-efb7-45ca-98ba-b3af3cee699a.html,,oral,LD50,"5,000 mg/kg bw",, "2-Propenoic acid, heptadecyl ester, branched",1473386-36-5," 2 -propenoic acid, heptadecyl ester, branched was tested in an OECD TG 407 repeated-dose 28 -day toxicity study in wistar rats including a recovery period of 2 weeks administration by gavage. Therefore, under the conditions of the present study the no observed adverse effect level (NOAEL) for this test compund in male and female Wistar rats of both seces was 150 mg/kg bw/d. In two OECD TG 422 combined repeated dose and reproductive/developmental toxicity screening test with the structural analogue 2-Propenoic acid, C12-14-alkyl esters (mixture of CAS no. 2156-97-0 and 21643-42-5) and Behenylacrylate (Acrylate 22 45 %, mixture of CAS no.: 4813-57-4, 48076-38-6, 18299-85-9; C18-22) by oral gavage in rats no toxicity occurred up to the highest administered dose of 1000 mg/kg bw/day. The NOAEL was determined to 1000 mg/kg bw/day. Based on these results the NOAEL value of 2-Propenoic acid, heptadecyl ester is also considered to be 1000 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3cd31d91-9596-4249-a985-34dbed926592/documents/IUC5-a6f65b5b-54d9-446e-bd21-5433d9ae33c0_3b637b28-9e6d-4994-9ed8-a41e4f9c6294.html,,,,,, "2-Propenoic acid, heptadecyl ester, branched",1473386-36-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3cd31d91-9596-4249-a985-34dbed926592/documents/IUC5-a6f65b5b-54d9-446e-bd21-5433d9ae33c0_3b637b28-9e6d-4994-9ed8-a41e4f9c6294.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "2-Propenoic acid, heptadecyl ester, branched",1473386-36-5,"LD50(rat) oral: > 2000 mg/kg bw (BASF, 2014)LD50(rat) dermal: > 5000 mg/kg bw (BASF, 2014) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cd31d91-9596-4249-a985-34dbed926592/documents/IUC5-0e089860-1652-4933-ba7b-9599db5d2fc8_3b637b28-9e6d-4994-9ed8-a41e4f9c6294.html,,,,,, "2-Propenoic acid, heptadecyl ester, branched",1473386-36-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cd31d91-9596-4249-a985-34dbed926592/documents/IUC5-0e089860-1652-4933-ba7b-9599db5d2fc8_3b637b28-9e6d-4994-9ed8-a41e4f9c6294.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-Propenoic acid, heptadecyl ester, branched",1473386-36-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cd31d91-9596-4249-a985-34dbed926592/documents/IUC5-0e089860-1652-4933-ba7b-9599db5d2fc8_3b637b28-9e6d-4994-9ed8-a41e4f9c6294.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "2-Propenoic acid, methyl ester, reaction products with 2-ethyl-1-hexanamine and sodium hydroxide",68610-44-6,"Oral toxicity - Methanol is officially classified Acute tox 3, H301 in Europe, with the following Specific Concentrations Limits STOT SE 1; H370: C >= 10% STOT SE 2; H371: 3% <= C < 10% - Experimental acute oral toxicity test (OECD 423) on the substance itself (""2-Propenoic acid, methyl ester, reaction products with 2-ethyl-1-hexanamine and sodium hydroxide"" (water and methanol free)).   Dermal toxicity - Methanol is officially classified Acute tox 3, H311 in Europe, with the following Specific Concentrations Limits STOT SE 1; H370: C >= 10% STOT SE 2; H371: 3% <= C < 10% - Experimental acute dermal toxicity (OECD 402) on the analogue substance ""Sodium N-(2 -carboxyethyl)-N-(2 -ethylhexyl)-β-alaninate, CAS 94441 -92 -6).   Inhalation toxicity - Methanol is officially classified Acute tox 3, H331 in Europe, with the following Specific Concentrations Limits STOT SE 1; H370: C >= 10% STOT SE 2; H371: 3% <= C < 10% - Experimental data on the susbtance itself (""2-Propenoic acid, methyl ester, reaction products with 2-ethyl-1-hexanamine and sodium hydroxide"" (water and methanol free)) is not available. However, according to the chemical and physical properties of the substance, and according to the Surfactants family, the exposition and the toxicity by inhalation are not expected. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e2155bd-7b79-4660-b42a-14fe07c9d45e/documents/cfc5fcee-5f55-4be2-bfce-5e05dd5359ab_77129605-cc4a-4fde-8ab1-418fb9b302c8.html,,,,,, "2-Propenoic acid, methyl ester, reaction products with 2-ethyl-1-hexanamine and sodium hydroxide",68610-44-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e2155bd-7b79-4660-b42a-14fe07c9d45e/documents/cfc5fcee-5f55-4be2-bfce-5e05dd5359ab_77129605-cc4a-4fde-8ab1-418fb9b302c8.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "2-Propenoic acid, methyl ester, reaction products with 2-ethyl-1-hexanamine and sodium hydroxide",68610-44-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e2155bd-7b79-4660-b42a-14fe07c9d45e/documents/cfc5fcee-5f55-4be2-bfce-5e05dd5359ab_77129605-cc4a-4fde-8ab1-418fb9b302c8.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, "2-Propenoic acid, methyl ester, reaction products with 2-ethyl-1-hexanamine and sodium hydroxide",68610-44-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e2155bd-7b79-4660-b42a-14fe07c9d45e/documents/cfc5fcee-5f55-4be2-bfce-5e05dd5359ab_77129605-cc4a-4fde-8ab1-418fb9b302c8.html,,inhalation,LC50,"10,000 mg/m3",adverse effect observed, "2-Propenoic acid, methyl ester, reaction products with mixed O,O-bis(branched and linear pentyl and iso-Bu) phosphorodithioates",93925-38-3,"Treatment of rats at dosages up to 750 mg/kg bw/day for twenty-eight consecutive days was well tolerated and the ‘No Observed Adverse Effect Level’ (NOAEL) for toxicity was considered to be 750 mg/kg bw/day.In a supporting study treatment of rats for 28-days by oral gavage gave a NOAEL of 500 mg/kg bw/day, the highest dose tested. Effects observed during the treatment period were reversed during a two-week recovery period. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d337b6b9-e1e4-401d-820f-916501177cab/documents/57c44f7a-d70c-494a-be4b-ab4fe6ed1f23_5392bc3e-f3df-48a8-851a-9aec2ca8e9fe.html,,,,,, "2-Propenoic acid, methyl ester, reaction products with mixed O,O-bis(branched and linear pentyl and iso-Bu) phosphorodithioates",93925-38-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d337b6b9-e1e4-401d-820f-916501177cab/documents/57c44f7a-d70c-494a-be4b-ab4fe6ed1f23_5392bc3e-f3df-48a8-851a-9aec2ca8e9fe.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "2-Propenoic acid, methyl ester, reaction products with mixed O,O-bis(branched and linear pentyl and iso-Bu) phosphorodithioates",93925-38-3," en animals (five males and five females) was given a single, 24 hour, semi-occluded dermal application of the undiluted test item ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d337b6b9-e1e4-401d-820f-916501177cab/documents/2916f841-e29e-43aa-a90c-19aa52eb372c_5392bc3e-f3df-48a8-851a-9aec2ca8e9fe.html,,,,,, "2-Propenoic acid, methyl ester, reaction products with mixed O,O-bis(branched and linear pentyl and iso-Bu) phosphorodithioates",93925-38-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d337b6b9-e1e4-401d-820f-916501177cab/documents/2916f841-e29e-43aa-a90c-19aa52eb372c_5392bc3e-f3df-48a8-851a-9aec2ca8e9fe.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "2-Propenoic acid, methyl ester, reaction products with mixed O,O-bis(branched and linear pentyl and iso-Bu) phosphorodithioates",93925-38-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d337b6b9-e1e4-401d-820f-916501177cab/documents/2916f841-e29e-43aa-a90c-19aa52eb372c_5392bc3e-f3df-48a8-851a-9aec2ca8e9fe.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Propenoic acid, reaction products with dipentaerythritol",1384855-91-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The information requirements for this tonnage band is sufficiently met with the available data. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/471a9b7d-3990-4a21-bc13-4026119e342b/documents/IUC5-241b0168-2e0e-4cc9-b4bf-a534d8140606_86a32e2e-c3fc-42fa-af03-1c209edbe0bb.html,,,,,, "2-Propenoic acid, reaction products with dipentaerythritol",1384855-91-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/471a9b7d-3990-4a21-bc13-4026119e342b/documents/IUC5-241b0168-2e0e-4cc9-b4bf-a534d8140606_86a32e2e-c3fc-42fa-af03-1c209edbe0bb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat "2-Propenoic acid, reaction products with dipentaerythritol",1384855-91-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/471a9b7d-3990-4a21-bc13-4026119e342b/documents/IUC5-241b0168-2e0e-4cc9-b4bf-a534d8140606_86a32e2e-c3fc-42fa-af03-1c209edbe0bb.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,12 mg/kg bw/day,,rat "2-Propenoic acid, reaction products with dipentaerythritol",1384855-91-7,"Based on the study results, the acute oral LD50 of the test substance was determined to be >2000 mg/kg bw.   Based on the results of read across study, the acute dermal LD50 of the test substance is considered to be >2000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The information requirements for this tonnage band is sufficiently met with the available data. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The information requirements for this tonnage band is sufficiently met with the available data. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/471a9b7d-3990-4a21-bc13-4026119e342b/documents/IUC5-4b86d4eb-bceb-401c-9372-cc2f16895e2b_86a32e2e-c3fc-42fa-af03-1c209edbe0bb.html,,,,,, "2-Propenoic acid, reaction products with dipentaerythritol",1384855-91-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/471a9b7d-3990-4a21-bc13-4026119e342b/documents/IUC5-4b86d4eb-bceb-401c-9372-cc2f16895e2b_86a32e2e-c3fc-42fa-af03-1c209edbe0bb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-Propenoic acid, reaction products with dipentaerythritol",1384855-91-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/471a9b7d-3990-4a21-bc13-4026119e342b/documents/IUC5-4b86d4eb-bceb-401c-9372-cc2f16895e2b_86a32e2e-c3fc-42fa-af03-1c209edbe0bb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Triisopropylsilyl acrylate,157859-20-6,"In the key 90-day repeated dose oral toxicity study with tri(isopropyl)silyl acrylate (CAS No. 157859-20-6, EC No. 457-670-6), conducted according to OECD Test Guideline 408 and in compliance with GLP,  the reported NOAEL for specific target organ toxicity was greater than 100 mg/kg bw/day based on no test item related effect observed on mortality, clinical signs, body weight development, food consumption, functional observation battery, weekly detailed clinical observations, haematology and blood coagulations, clinical biochemistry, urinalysis, gross pathological findings, organ weight and histopathology (Eurofins / BSL Bioservice, 2018a, reliability 1). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78132292-f99c-47f7-b080-deaa35236b26/documents/81700678-8fc2-4b5a-a063-7a3735ec4cdb_0546ae0f-032d-4191-b93d-7a3d298b7878.html,,,,,, Triisopropylsilyl acrylate,157859-20-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78132292-f99c-47f7-b080-deaa35236b26/documents/81700678-8fc2-4b5a-a063-7a3735ec4cdb_0546ae0f-032d-4191-b93d-7a3d298b7878.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,>= 100 mg/kg bw/day,,rat Triisopropylsilyl acrylate,157859-20-6,"The key study for acute oral toxicity study in rats was conducted according to OECD Test Guideline 423 and in compliance with GLP. The LD50 identified for tri(isopropyl)silyl acrylate (CAS No. 157859-20-6, EC No. 457-670-6) was >2000 mg/kg bw (RCC 2004a).   The key study for acute dermal toxicity study in rats, was conducted according to OECD Test Guideline 402 and in compliance with GLP. The LD50 identified for tri(isopropyl)silyl acrylate (CAS No. 157859-20-6, EC No. 457-670-6) was >2000 mg/kg bw (RCC 2004b).   In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5.2) does not need to be conducted as reliable data via the oral and dermal routes are available. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78132292-f99c-47f7-b080-deaa35236b26/documents/d9ef85ce-6c70-4a5d-bc8d-5cc6fd8ff0a7_0546ae0f-032d-4191-b93d-7a3d298b7878.html,,,,,, Triisopropylsilyl acrylate,157859-20-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78132292-f99c-47f7-b080-deaa35236b26/documents/d9ef85ce-6c70-4a5d-bc8d-5cc6fd8ff0a7_0546ae0f-032d-4191-b93d-7a3d298b7878.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Triisopropylsilyl acrylate,157859-20-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78132292-f99c-47f7-b080-deaa35236b26/documents/d9ef85ce-6c70-4a5d-bc8d-5cc6fd8ff0a7_0546ae0f-032d-4191-b93d-7a3d298b7878.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2-Propenoic acid, γ-ω-perfluoro-C8-14-alkyl esters",85631-54-5," No sub-chronic 90-day toxicity study in rat with the registration substance (target substance) is available. As described in more detail in the read-across justification and based on the consistency in effects seen in the comparative 14 day-repeated dose studies performed with both the target as well as the source substance coupled with knowledge on metabolism, it is reasonable to read-across the information from the available 90-day study on the mixed n:2 FTOH to address the data gap for the registration substance. The NOAEL in a 90-day repeated oral dose study in rats with Fluoroalkylethanol mixture is 25 mg/kg/day and will be used as conservative NOAEL also for the registration substance. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8731c9d1-ec60-4b32-8944-916f69ed0c5a/documents/d98e3ef9-ab58-4fa0-95d0-91872f44f811_2ada4157-97c1-4a06-957b-925f4d41f054.html,,,,,, "2-Propenoic acid, γ-ω-perfluoro-C8-14-alkyl esters",85631-54-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8731c9d1-ec60-4b32-8944-916f69ed0c5a/documents/d98e3ef9-ab58-4fa0-95d0-91872f44f811_2ada4157-97c1-4a06-957b-925f4d41f054.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat "2-Propenoic acid, γ-ω-perfluoro-C8-14-alkyl esters",85631-54-5," The acute oral median lethal dose (LD50) of the test substance registered were determined in an OECD 401 acute toxicity test. A supporting study performed as ALD (Approximate lethal Dose) study is also available. The acute inhalation toxicity of the test substance registered were determined in an Approximate Lethal Concentration (ALC) study, where two groups of 6 male rats were exposed nose-only, a single 4 -hour period to the test substance in air. According to REACH 1972/2006, Annex VIII, column 2, 8.5, in addition to oral route, for substance other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. Thus, the acute dermal toxicity study can be waived since the data of acute toxicity by oral and inhalation route is available and sufficient for assessment of acute toxicity of the registration substance. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8731c9d1-ec60-4b32-8944-916f69ed0c5a/documents/543115ef-efd0-4e41-b786-25d002672d97_2ada4157-97c1-4a06-957b-925f4d41f054.html,,,,,, "2-Propenoic acid, γ-ω-perfluoro-C8-14-alkyl esters",85631-54-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8731c9d1-ec60-4b32-8944-916f69ed0c5a/documents/543115ef-efd0-4e41-b786-25d002672d97_2ada4157-97c1-4a06-957b-925f4d41f054.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-propylheptan-1-ol,10042-59-8,"- oral: rat (male/female), subchronic, gavage (BASF, 1996; reliable), OECD 408; GLP-conform: 1.) NOAEL(males/females) - disregarding peroxisome proliferation: 150 mg/kg bw (based on effects relevant for human hazard: impairment of food consumption/body weight/body weight change, decreased mean terminal body weight, hematology, clinical chemistry, increase in squamous epithelial cells in the urine) 2.) NOAEL(males): 150 mg/kg bw, NOAEL(females): 30 mg/kg bw; main target organ: liver (probably related to a peroxisome proliferating potential) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ff2b99a-2984-46a2-ac7b-93f0a0756472/documents/IUC5-9a5a6ee3-c4e1-40c5-8877-7bedec121c5e_54b73495-4758-4df2-a4bb-364e86bad5c1.html,,,,,, 2-propylheptan-1-ol,10042-59-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ff2b99a-2984-46a2-ac7b-93f0a0756472/documents/IUC5-9a5a6ee3-c4e1-40c5-8877-7bedec121c5e_54b73495-4758-4df2-a4bb-364e86bad5c1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat 2-propylheptan-1-ol,10042-59-8,"- acute oral: rat (male/female): LD50 = 5400 mg/kg bw (TSCAT, OTS 0538594, Doc I.D. 88-920007511, Monsanto Company, 1979; reliable with restrictions)- acute inhalative: rat (male/female): IRT, no mortality after the 8 hour-exposure to saturated vapor (at 20°C) (Smyth, H.F. et al., 1962; reliable with restrictions)- acute dermal: rabbit (male/female): LD50 > 5100 mg/kg bw (TSCAT, OTS 0538594, Doc I.D. 88-920007511, Monsanto Company, 1979; reliable with restrictions) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ff2b99a-2984-46a2-ac7b-93f0a0756472/documents/IUC5-a5d7491d-b535-4422-9b54-a1881872756c_54b73495-4758-4df2-a4bb-364e86bad5c1.html,,,,,, 2-propylheptan-1-ol,10042-59-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ff2b99a-2984-46a2-ac7b-93f0a0756472/documents/IUC5-a5d7491d-b535-4422-9b54-a1881872756c_54b73495-4758-4df2-a4bb-364e86bad5c1.html,,oral,LD50,"5,400 mg/kg bw",adverse effect observed, 2-propylheptan-1-ol,10042-59-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ff2b99a-2984-46a2-ac7b-93f0a0756472/documents/IUC5-a5d7491d-b535-4422-9b54-a1881872756c_54b73495-4758-4df2-a4bb-364e86bad5c1.html,,dermal,discriminating dose,"5,010 mg/kg bw",adverse effect observed, 2-propylheptan-1-ol,10042-59-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ff2b99a-2984-46a2-ac7b-93f0a0756472/documents/IUC5-a5d7491d-b535-4422-9b54-a1881872756c_54b73495-4758-4df2-a4bb-364e86bad5c1.html,,inhalation,discriminating conc.,0.13 ,no adverse effect observed, 2-propylheptyl 2-methylprop-2-enoate,149855-64-1,"No reliable studies concerning repeated dose toxicity were identified for 2-propylheptyl methacrylate (PHMA). However, data from the structural analogue 2-ethylhexyl methacrylate (CAS: 688-84-6) is considered appropriate for the assessment, due to their structural and physic-chemical similarities. In an oral OECD 408 study performed according GLP, the no observed adverse effect level (NOAEL) was 120 mg/kg bw/day in male and female Wistar rats (BASF, 2009). In an combined repeated dose and reproductive toxicity screening study (OECD 422) the NOAEL was 100 mg/kg bw/day. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e60e2b6-38be-4f6c-a026-48d1e6dcbcba/documents/IUC5-7f4c3286-6cca-409e-a790-f4e117c8241f_a2aeee3d-c952-4e69-b0bf-2a04e112632d.html,,,,,, 2-propylheptyl 2-methylprop-2-enoate,149855-64-1,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e60e2b6-38be-4f6c-a026-48d1e6dcbcba/documents/IUC5-7f4c3286-6cca-409e-a790-f4e117c8241f_a2aeee3d-c952-4e69-b0bf-2a04e112632d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat 2-propylheptyl 2-methylprop-2-enoate,149855-64-1,"oral: LD50 (rat): >2000 mg/kg bw (BASF SE, 2014)dermal: LD50 (rat): > 5000 mg/kg bw (BASF SE, 2014) ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e60e2b6-38be-4f6c-a026-48d1e6dcbcba/documents/IUC5-f682b190-596d-4508-9197-2e4970ca085d_a2aeee3d-c952-4e69-b0bf-2a04e112632d.html,,,,,, 2-propylheptyl 2-methylprop-2-enoate,149855-64-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e60e2b6-38be-4f6c-a026-48d1e6dcbcba/documents/IUC5-f682b190-596d-4508-9197-2e4970ca085d_a2aeee3d-c952-4e69-b0bf-2a04e112632d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-propylheptyl 2-methylprop-2-enoate,149855-64-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e60e2b6-38be-4f6c-a026-48d1e6dcbcba/documents/IUC5-f682b190-596d-4508-9197-2e4970ca085d_a2aeee3d-c952-4e69-b0bf-2a04e112632d.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Reaction product of 2-Propyn-1-ol with methyloxirane,38172-91-7," OECD 422 (TNO Triskelion, 2013): NOAEL = 125 mg/kg bw/day (systemic and local) OECD 408 (BASF SE, 2017): NOAEL = 30 mg/kg bw/day (systemic and local), LOAEL = 150 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57ce4589-b6b4-424e-9303-cb0dcb914197/documents/IUC5-c82d269f-f1cc-4c8c-935b-a310ff648116_ec9a79ff-bb75-48f3-b4e4-e8c1595d6537.html,,,,,, Reaction product of 2-Propyn-1-ol with methyloxirane,38172-91-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57ce4589-b6b4-424e-9303-cb0dcb914197/documents/IUC5-c82d269f-f1cc-4c8c-935b-a310ff648116_ec9a79ff-bb75-48f3-b4e4-e8c1595d6537.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat Reaction product of 2-Propyn-1-ol with methyloxirane,38172-91-7,"acute toxicity test, rat oral (BASF AG, 1987): LD50(oral) > 464 mg/kg < 2150 mg/kginhalaton hazard test, rat inhalativ (BASF AG, 1987): No mortality occured when rats were exposed to the saturated vapor for 7 hours.acute dermal toxicity (BASF, 2012): LD50(dermal) > 2000 mg/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57ce4589-b6b4-424e-9303-cb0dcb914197/documents/IUC5-a5b50c0c-50ec-41e5-87f7-25669888c965_ec9a79ff-bb75-48f3-b4e4-e8c1595d6537.html,,,,,, "(R)-5-bromo-3-(1-(2,6-dichloro-3-fluorophenyl)ethoxy)pyridin-2-amine",877399-00-3,"A 7-day repeated dose study (Beerens-Heijnen, 2011) is available which is key study. The test substance has toxic potential when administered to rats by daily oral gavage for a period of up to 7 consecutive days at 150 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/250f76c1-cb0e-42ca-9868-a4bd58a341ab/documents/IUC5-27e8cb19-3ac6-4d3a-aa11-9c54dee1cf0d_b5075aad-c669-44dd-bb17-3d91b85425f1.html,,,,,, "(R)-5-bromo-3-(1-(2,6-dichloro-3-fluorophenyl)ethoxy)pyridin-2-amine",877399-00-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/250f76c1-cb0e-42ca-9868-a4bd58a341ab/documents/IUC5-27e8cb19-3ac6-4d3a-aa11-9c54dee1cf0d_b5075aad-c669-44dd-bb17-3d91b85425f1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "(R)-5-bromo-3-(1-(2,6-dichloro-3-fluorophenyl)ethoxy)pyridin-2-amine",877399-00-3,"Acute oral toxicity: A primary oral toxicity study (Beerens-Heijnen, 2010) was available which is key study. This study showed that the oral LD50 value of test substance is established to exceed 2000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/250f76c1-cb0e-42ca-9868-a4bd58a341ab/documents/IUC5-ffd524ae-34ef-49cf-98ef-31eeaf330f11_b5075aad-c669-44dd-bb17-3d91b85425f1.html,,,,,, "(R)-5-bromo-3-(1-(2,6-dichloro-3-fluorophenyl)ethoxy)pyridin-2-amine",877399-00-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/250f76c1-cb0e-42ca-9868-a4bd58a341ab/documents/IUC5-ffd524ae-34ef-49cf-98ef-31eeaf330f11_b5075aad-c669-44dd-bb17-3d91b85425f1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-(4-Amino-3-fluorophenoxy)-N-methylpyridine-2-carboxamide,757251-39-1,"AFP-Picolinmethylamid is harmful after single oral exposure (LD50 >300 <2000 mg/kg bw). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is GLP compliant and is of high quality (Klimisch score=1) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5e549d6-f741-496b-8d5d-f7d19e63c592/documents/IUC5-47335cf9-476d-41e0-bea2-894835cceb3c_07742f15-28d5-4c13-9435-b97597e025cb.html,,,,,, 4-(4-Amino-3-fluorophenoxy)-N-methylpyridine-2-carboxamide,757251-39-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5e549d6-f741-496b-8d5d-f7d19e63c592/documents/IUC5-47335cf9-476d-41e0-bea2-894835cceb3c_07742f15-28d5-4c13-9435-b97597e025cb.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, 4-(4-aminophenoxy)-N-methylpyridine-2-carboxamide,284462-37-9,"LD50 oral cut-off(rat): 2000 mg/kg bw [report, Schüngel 2004] Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is GLP compliant and is of high quality (Klimisch score=1) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29f29f4e-dc90-4009-8d31-88ad5139831e/documents/IUC5-ebc32a8d-1ff0-4ced-9614-a44fa5d34b65_22213c52-c7d0-4ba7-bf23-da188ae68011.html,,,,,, 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)phenoxy]-N-methylpyridine-2-carboxamide,284461-73-0,"BAY 54-9085 (tosylate salt of BAY 43-9006) revealed adverse effects in multiple organs (kidneys, liver, pancreas, lymphoreticular/hematopoetic system, gastrointestinal (GI) tract, adrenals, reproductive organs, skin, bones, teeth) after repeated oral administration to rats and mice (lowest NOAEL from 2-year carcinogenicity study in rats: 0.3 mg/kg bw/day). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study is GLP compliant and is of high quality (Klimisch score=1) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/40bd58ba-3e6d-42f5-9a13-6b6c08567b7f/documents/IUC5-182b7344-4220-42b0-ab36-c80a8ecc3e2f_c51c8efd-d916-43aa-b4ac-7bce3a622a93.html,,,,,, 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)phenoxy]-N-methylpyridine-2-carboxamide,284461-73-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/40bd58ba-3e6d-42f5-9a13-6b6c08567b7f/documents/IUC5-182b7344-4220-42b0-ab36-c80a8ecc3e2f_c51c8efd-d916-43aa-b4ac-7bce3a622a93.html,Chronic toxicity – systemic effects,oral,NOAEL,0.22 mg/kg bw/day,,rat 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)phenoxy]-N-methylpyridine-2-carboxamide,284461-73-0,"oral LD50 rat: > 1460 mg/kg bw (read-across from BAY 54-9085, taking into account the different molecular weight) (Renhof, 2000) dermal LD50 rat: > 2000 mg/kg bw (Gillissen, 2015) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is GLP compliant and is of high quality (Klimisch score=1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study is GLP compliant and is of high quality (Klimisch score=1) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40bd58ba-3e6d-42f5-9a13-6b6c08567b7f/documents/IUC5-2f58a450-1393-48a1-b28b-37ad44fb35de_c51c8efd-d916-43aa-b4ac-7bce3a622a93.html,,,,,, 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)phenoxy]-N-methylpyridine-2-carboxamide,284461-73-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40bd58ba-3e6d-42f5-9a13-6b6c08567b7f/documents/IUC5-2f58a450-1393-48a1-b28b-37ad44fb35de_c51c8efd-d916-43aa-b4ac-7bce3a622a93.html,,oral,discriminating dose,"1,460 mg/kg bw",no adverse effect observed, 4-[4-({[4-chloro-3-(trifluoromethyl)phenyl]carbamoyl}amino)phenoxy]-N-methylpyridine-2-carboxamide,284461-73-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40bd58ba-3e6d-42f5-9a13-6b6c08567b7f/documents/IUC5-2f58a450-1393-48a1-b28b-37ad44fb35de_c51c8efd-d916-43aa-b4ac-7bce3a622a93.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 4-chloro-N-methylpyridine-2-carboxamide hydrochloride (1:1),882167-77-3,"4-Chlorpicolinmethylamid HCl is harmful after single oral exposure in rat: LD50 300-2000 mg/kg bw Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is GLP compliant and is of high quality (Klimisch score=1) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acf5bb70-90e9-4088-96c6-6489f0e20f99/documents/IUC5-80c7e931-9cd6-426a-822d-ecafdf437ab6_a06a9daa-3e89-4816-a1da-8790ab4e0f67.html,,,,,, 4-chloro-N-methylpyridine-2-carboxamide hydrochloride (1:1),882167-77-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acf5bb70-90e9-4088-96c6-6489f0e20f99/documents/IUC5-80c7e931-9cd6-426a-822d-ecafdf437ab6_a06a9daa-3e89-4816-a1da-8790ab4e0f67.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, "Sodium {[3-(2,2,2-trifluoroethoxy)-2-pyridinyl]sulfonyl}azanide",227605-94-9,"Key studies were available for oral, inhalation and dermal toxicity, showing following results:- LD50 for oral toxicity: > 200 mg/kg in male rats; >200 and < 2000 mg/kg in female Wistar rats; - LC50 for inhalation toxicity (nose only method): 5.651 mg/L air in male and female Wistar rats; - LD50 for dermal toxicity: >2000 mg/kg in male and female Wistar rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5b0fc5c-78d5-4c52-a4b5-df46212ae300/documents/f5e54353-7a2b-4914-a4db-0620885fa53e_7152afa8-953a-4b47-b48c-319fef71cc0a.html,,,,,, "Sodium {[3-(2,2,2-trifluoroethoxy)-2-pyridinyl]sulfonyl}azanide",227605-94-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5b0fc5c-78d5-4c52-a4b5-df46212ae300/documents/f5e54353-7a2b-4914-a4db-0620885fa53e_7152afa8-953a-4b47-b48c-319fef71cc0a.html,,oral,LD50,200 mg/kg bw,adverse effect observed, "Sodium {[3-(2,2,2-trifluoroethoxy)-2-pyridinyl]sulfonyl}azanide",227605-94-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5b0fc5c-78d5-4c52-a4b5-df46212ae300/documents/f5e54353-7a2b-4914-a4db-0620885fa53e_7152afa8-953a-4b47-b48c-319fef71cc0a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sodium {[3-(2,2,2-trifluoroethoxy)-2-pyridinyl]sulfonyl}azanide",227605-94-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5b0fc5c-78d5-4c52-a4b5-df46212ae300/documents/f5e54353-7a2b-4914-a4db-0620885fa53e_7152afa8-953a-4b47-b48c-319fef71cc0a.html,,inhalation,LC50,"5,651 mg/m3",no adverse effect observed, "sodium (4,6-dimethoxypyrimidin-2-yl)carbamoyl-[[3-(2,2,2-trifluoroethoxy)-2-pyridyl]sulfonyl]azanide",199119-58-9,"ORALThe NOAEL was determined to be 83 mg/kg bw/day (male) according to a 4 week rat study performed in line with OECD Guideline 407 and EU Method B.7 – Gerspach 2001The NOEL was determined to be 65.7 mg/kg bw/day (male) according to a 90 day rat study performed in line with EPA Guideline 82-1 and OECD 408 – Gerspach 1998aThe NOEL was determined to be 67.9 mg/kg bw/day (male) according to a 90 day mice study performed in line with EPA Guideline 82-1 and OECD 408 – Gerspach 1998bThe NOEL was determined to be 19.6 mg/kg bw/day (female) according to a 90 day dog study performed in line with EPA Guideline 82-1 and OECD 409 – Altmann 2000The NOEL was determined to be 14.9 mg/kg bw/day (female) according to a 12 month study with dogs performed in line with OECD 409 and EPA OPP 82-1 - Altmann 2000bThe NOEL was determined to be 112 mg/kg bw/day (female) according to an 18 month study with mice performed in line with OECD 451 and EPA OPP 83-2 - Gerspach 2000aThe NOEL was determined to be 23.7 mg/kg bw/day (female) according to a 24 month study with rats performed in line with OECD 453 and EPA OPP 83-5 - Gerspach 2000bDERMALThe NOAEL was determined to be 100 mg/kg bw/day (female rats) according to a study performed in line with EPA Guideline 82-2, OECD 410 and EU Method B.9 - Gerspach 1998 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4baf85cf-d4de-48f9-a719-e4da5994cb5e/documents/IUC5-e3875b9e-2367-456d-b0ea-d4bff8cc12ad_c6cecf10-cdef-4e3e-84c9-2a8814a084ed.html,,,,,, "sodium (4,6-dimethoxypyrimidin-2-yl)carbamoyl-[[3-(2,2,2-trifluoroethoxy)-2-pyridyl]sulfonyl]azanide",199119-58-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4baf85cf-d4de-48f9-a719-e4da5994cb5e/documents/IUC5-e3875b9e-2367-456d-b0ea-d4bff8cc12ad_c6cecf10-cdef-4e3e-84c9-2a8814a084ed.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,,rat "sodium (4,6-dimethoxypyrimidin-2-yl)carbamoyl-[[3-(2,2,2-trifluoroethoxy)-2-pyridyl]sulfonyl]azanide",199119-58-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4baf85cf-d4de-48f9-a719-e4da5994cb5e/documents/IUC5-e3875b9e-2367-456d-b0ea-d4bff8cc12ad_c6cecf10-cdef-4e3e-84c9-2a8814a084ed.html,Chronic toxicity – systemic effects,oral,NOAEL,23.7 mg/kg bw/day,,rat "sodium (4,6-dimethoxypyrimidin-2-yl)carbamoyl-[[3-(2,2,2-trifluoroethoxy)-2-pyridyl]sulfonyl]azanide",199119-58-9,"Oral: LD50 = > 5000 mg/kg bw male/female rat, mouse, OECD 401, EU Method B.1, EPA OPP 81-1, Gillis 1997aDermal: LD50 = > 2000 mg/kg bw male/female rat, OECD 402, EU Method B.3, EPA OPP 81-2 - Gillis 1997cInhalation: LC50 = > 5.03 mg/L air male/female rat, OECD 403, EU Method B.2, EPA OTS 798.1150, Decker & Biedermann 1997 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4baf85cf-d4de-48f9-a719-e4da5994cb5e/documents/IUC5-e4045775-7acc-4502-ae74-5794943c9bc6_c6cecf10-cdef-4e3e-84c9-2a8814a084ed.html,,,,,, 2-pyridylamine,504-29-0," Acute oral toxicity. Weight of evidence. Based on the available information (peer reviewed handbook data), the oral LD50 in rats is 200 mg/kg bw. Acute inhalation toxicity. No study available. Supporting data: According to handbook data, a tolerance of 0.5 ppm in humans has been reported. Acute dermal toxicity. Supporting study. The LD50 of the test item in guinea pigs is 500 mg/kg bw, according to peer reviewed handbook data. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6035f241-7d67-46f9-8f52-c0a36dda45af/documents/5ae880b3-9911-4d50-a477-d41d165ddeaa_52497107-c50a-4965-b75c-b111e4be066c.html,,,,,, 2-pyridylamine,504-29-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6035f241-7d67-46f9-8f52-c0a36dda45af/documents/5ae880b3-9911-4d50-a477-d41d165ddeaa_52497107-c50a-4965-b75c-b111e4be066c.html,,oral,LD50,200 mg/kg bw,adverse effect observed, 2-pyridylamine,504-29-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6035f241-7d67-46f9-8f52-c0a36dda45af/documents/5ae880b3-9911-4d50-a477-d41d165ddeaa_52497107-c50a-4965-b75c-b111e4be066c.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, 2-sec-butylphenol,89-72-5,NOEL (repeated dose toxicity): 12 mg/kg bw/day (actual dose received) (male)NOEL (repeated dose toxicity): 60 mg/kg bw/day (actual dose received) (female)NOEL (reproductive and developmental toxicity): 300 mg/kg bw/day (actual dose received) (male/female) ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cce9b0bb-e326-4599-81c5-85c2146a6aeb/documents/a65fbc70-5046-458b-a599-197ea3594da9_6ecc1e59-b905-41c8-93c7-5915cf835d8e.html,,,,,, 2-sec-butylphenol,89-72-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cce9b0bb-e326-4599-81c5-85c2146a6aeb/documents/a65fbc70-5046-458b-a599-197ea3594da9_6ecc1e59-b905-41c8-93c7-5915cf835d8e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,12 mg/kg bw/day,,rat 2-sec-butylphenol,89-72-5," Acute toxicity oral: LD50 in Sprague-Dawley strain rat > 200 - < 2000 mg/kg body weight. CLP Category 4, H302. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cce9b0bb-e326-4599-81c5-85c2146a6aeb/documents/0e86af0c-e82d-4c82-b408-bce48899c43c_6ecc1e59-b905-41c8-93c7-5915cf835d8e.html,,,,,, 2-sec-butylphenol,89-72-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cce9b0bb-e326-4599-81c5-85c2146a6aeb/documents/0e86af0c-e82d-4c82-b408-bce48899c43c_6ecc1e59-b905-41c8-93c7-5915cf835d8e.html,,oral,LD50,200 mg/kg bw,adverse effect observed, 2-tert-butylphenol,88-18-6,"An OECD guideline 408 90 day repeated dose study on o-tert-butylphenol. In addition, OECD guideline 407 28 day study on o-tert butyl phenol and an OECD gudieline 422 study on read across analogues o-sec butyl phenol, both from the Japanese Ministry of Health. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64d1907d-7fa1-4f83-93bb-0ad11be6b282/documents/IUC5-7d393637-c299-4943-8234-c1dd5f5c24a0_954b4a89-9f1b-4704-9da9-faef7ba97236.html,,,,,, 2-tert-butylphenol,88-18-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64d1907d-7fa1-4f83-93bb-0ad11be6b282/documents/IUC5-7d393637-c299-4943-8234-c1dd5f5c24a0_954b4a89-9f1b-4704-9da9-faef7ba97236.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 2-tert-butylphenol,88-18-6,Two key oral acute toxicity studies: Gardner 1990 study (OECD guideline 401 study performed to GLP) and Taupin 1981 study (US 1981 guideline method).Two supporting studies for the oral route: Tufnell 1991 and Yamashita 2000 (both OECD guideline 401 studies).One dermal acute toxicity study: Gardner 1990. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64d1907d-7fa1-4f83-93bb-0ad11be6b282/documents/IUC5-29f1b479-726a-4ac7-a1ed-908449156d90_954b4a89-9f1b-4704-9da9-faef7ba97236.html,,,,,, 2-tert-butylphenol,88-18-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64d1907d-7fa1-4f83-93bb-0ad11be6b282/documents/IUC5-29f1b479-726a-4ac7-a1ed-908449156d90_954b4a89-9f1b-4704-9da9-faef7ba97236.html,,oral,LD50,789 mg/kg bw,adverse effect observed, 2-tert-butylphenol,88-18-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64d1907d-7fa1-4f83-93bb-0ad11be6b282/documents/IUC5-29f1b479-726a-4ac7-a1ed-908449156d90_954b4a89-9f1b-4704-9da9-faef7ba97236.html,,dermal,LD50,705 mg/kg bw,adverse effect observed, 2-thiazolidinylidenecyanamide,26364-65-8,"  Repeated Dose Tox in vivo (Rats, subchronic, OECD TG 408): NOAEL = 70 mg/kg bw Applicant's conclusion: Based on the results of the present test, it can be concluded that, at a dose of 70 mg/kg, the 2-cyanoimino-1,3-thiazolidine 90-day repeated exposure oral toxicity test in rats produced no obvious toxicity effects in SD rats.   Repeated Dose Tox in vivo (Rats, 4 weeks, OECD TG 407): LOAEL = 15 mg/kg bw The systemic tolerance of rats to the test item was examined in a subacute toxicity study involving oral administration by gavage (four-week treatment). The study methodology conformed to the OECD-Guideline for Testing of Chemicals; Section 4: Health Effects, No. 407 (updated July 27, 1995; OECD Guidelines for Testing of Chemicals, Section 4, Health Effects). Groups of 5 male and 5 female rats of the strain WU were administered the test item each day at levels of 0, 15, 50 and 140 mg/kg orally by gavage over a period of 4 weeks. At 50 mg/kg body weight and below there was no difference between the treated and untreated animals regarding survival rate, state of health or general behavior of the animals, feed intake, body weights or body weight development, red blood cells including erythrocyte morphology, white blood cells, hemogram and blood coagulation. At 140 mg/kg, in females transiently piloerection occured, and in one female feces was discoloured. At 140 mg/kg the feed intake was decreased in the first week of treatment, and a slight retardation in body weight development was observed. At 140 mg/kg, the counts of neutrophiles were increased in males. At 15 mg/kg and above in both sexes lower concentrations of triglycerides were noted. Relative liver weights of females treated with 140 mg/kg were statistically significant increased. However, no similar finding was apparent in males and no morphological correlate was seen in the hisopathological examination. At 15 mg/kg and above in males and at 50 mg/kg and above in females, an increase in number and size of the germinal centers of the lymph follicles was detected in the spleen. This effect is regarded as a treatment related immunostimulation of the spleen. The significance of the germinal centre reaction observed at 140 mg/kg animals in the mandibular lymph nodes remains equivocal due to the higher physiologic variability with respect to germinal center reactions and to the greater variation of available tissue in the specimen. The detailed clinical observations including home cage, handling and open field behavior using some elements of the functional observational battery (FOB), the observation of reflexes and the results of the grip strength measurements, and the assessment of motor and locomotor activity showed no indication of neurotoxic changes during the treatment for males and for females. The observed effects in animals at 140 mg/kg most probably reflect the described alterations of the general health status. In conclusion, administration of the test item to Wistar Unilever rats for 4 weeks in concentrations of 15 mg/kg and higher resulted in toxic effects. Main target is the hematopoietic system. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b91629d-0b7f-4246-8064-a59450dae3e2/documents/2615070a-a472-43f5-85ba-86633328b3ce_9717a1fa-d626-4b1c-9d3d-2121c1078aa4.html,,,,,, 2-thiazolidinylidenecyanamide,26364-65-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b91629d-0b7f-4246-8064-a59450dae3e2/documents/2615070a-a472-43f5-85ba-86633328b3ce_9717a1fa-d626-4b1c-9d3d-2121c1078aa4.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,>= 15 mg/kg bw/day,,rat 2-thiazolidinylidenecyanamide,26364-65-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b91629d-0b7f-4246-8064-a59450dae3e2/documents/2615070a-a472-43f5-85ba-86633328b3ce_9717a1fa-d626-4b1c-9d3d-2121c1078aa4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,70 mg/kg bw/day,,rat 2-thiazolidinylidenecyanamide,26364-65-8,"Acute toxicity: oral (rats, OECD TG 423): LD50: > 300 < 2000 mg/kg bw Two studies for acute oral toxicity in male and female rats were conducted with the test substance according to OECD Guideline 423. For the test substance investigated a LD50 of > 300 < 2000 mg/kg b.w. was determined.   Acute toxicity: inhalation (rats, OECD TG 436): LC50, 4h: > 5.23 mg/L The study was designed according to OECD 436 to assess the acute inhalation toxicity of the test item after being snout-only administrated to SD rats for 4 hours and to serve as a basis for classification and labelling. Based on the results, the acute inhalation LC50 in SD rats for the test item in 4 hours exposure period is > 5.23 mg/L.   Acute toxicity: inhalation (rats, OECD TG 403): LC50 > 1508 mg/m³; NO(A)EL < 503 mg/m³ air In this study adressing the acute inhalation toxicity of the test item on rats has been conducted in accordance with OECD Guideline 403. Groups of rats were nose-only exposed to an average solid aerosol concentration (micronized dust) of 503 and 1508 mg/m³ air. Attemps were made so that aerosol generated was respirable to rats.   Acute toxicity: dermal (rats, OECD TG 402): LD50: > 2000 mg/kg bw The study was performed to asses the acute dermal toxicity of the test item in male and female SD rats according to the OECD guideline 402.The single dermal administration of the test substance to the rats at a dose of 2000 mg/kg bw was tolerated without any mortality or compound-related clinical or macroscopic pathological signs.The LD50 acute dermal toxicity in male and female SD rats was estimated to be > 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b91629d-0b7f-4246-8064-a59450dae3e2/documents/5a5b7997-aa7b-4e16-8bb0-b45b3ef13025_9717a1fa-d626-4b1c-9d3d-2121c1078aa4.html,,,,,, 2-thiazolidinylidenecyanamide,26364-65-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b91629d-0b7f-4246-8064-a59450dae3e2/documents/5a5b7997-aa7b-4e16-8bb0-b45b3ef13025_9717a1fa-d626-4b1c-9d3d-2121c1078aa4.html,,oral,LD50,"< 2,000 mg/kg bw",adverse effect observed, 2-thiazolidinylidenecyanamide,26364-65-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b91629d-0b7f-4246-8064-a59450dae3e2/documents/5a5b7997-aa7b-4e16-8bb0-b45b3ef13025_9717a1fa-d626-4b1c-9d3d-2121c1078aa4.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-thiazolidinylidenecyanamide,26364-65-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b91629d-0b7f-4246-8064-a59450dae3e2/documents/5a5b7997-aa7b-4e16-8bb0-b45b3ef13025_9717a1fa-d626-4b1c-9d3d-2121c1078aa4.html,,inhalation,LC50,5.23 mg/L,no adverse effect observed, methyl 5-amino-4-cyano-3-methylthiophene-2-carboxylate,61320-65-8,"To assess acute oral toxicity, female rats were tested according to OECD TG 423 and GLP. 2000 mg/kg bw was tolerated without mortalities, clinical signs, effects on weight gain or gross pathological findings. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70b4b551-c6b8-4f43-92a1-073fa124adc6/documents/IUC5-643d6a6a-e38d-40e6-9025-68a9cd7e6b79_57c1fe62-c0cf-4115-a5e2-f548de519e06.html,,,,,, 5-CHLOROTHIOPHENE-2-CARBOXYLIC ACID,24065-33-6,"Study conducted according to OECD test guideline 407, Wistar rats 5/sex/dose; 5-Chlorthiophen-2-carbonsäure in  2% Chremophor EL® administered by gavage at dose levels of 0 (control), 50, 170 and 500 mg/kg bw/day for 28 consecutive days; result: NOAEL: 50 mg/kg bw/d Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Study conducted according to OECD test guideline 407, reliability is considered high ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e30980fe-1af8-4520-97ed-876b7320c069/documents/9c49e13e-188e-482a-88d0-ee9d02aee37d_95127113-3c81-40a0-b03c-f47881e4aeb4.html,,,,,, 5-CHLOROTHIOPHENE-2-CARBOXYLIC ACID,24065-33-6,"Study conducted according to OECD test guideline 423; 9 female, fasted, 10-12 weeks old Wistar strain rats were given a single oral dose of 5-Chlorthiophen-2-carbonsäure in demineralized water containing 2% Cremophor by gavage at a dose of 2000 and 300 mg/kg bw and observed for 14 days, result: LD50 ≥ 300 mg/kg bw ≤ 2000 mg/kg bw. Study conducted according to OECD test guideline 402; one young adult male and female Wistar rats (1/sex) were dermally exposed to 5-Chlorthiophen-2-carbonsäure (100 % a.i) for 24 hours to 10 % of body surface area at a doses of 2000 mg/kg bw, result: LD50 > 2000 mg/kg bw.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Guideline study, reliability high Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Guideline study, reliability high ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e30980fe-1af8-4520-97ed-876b7320c069/documents/4bfe5a87-8ac1-43e4-aace-68c8dc6b6c92_95127113-3c81-40a0-b03c-f47881e4aeb4.html,,,,,, 5-CHLOROTHIOPHENE-2-CARBOXYLIC ACID,24065-33-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e30980fe-1af8-4520-97ed-876b7320c069/documents/4bfe5a87-8ac1-43e4-aace-68c8dc6b6c92_95127113-3c81-40a0-b03c-f47881e4aeb4.html,,oral,LD50,>=300 mg/kg bw,adverse effect observed, 5-CHLOROTHIOPHENE-2-CARBOXYLIC ACID,24065-33-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e30980fe-1af8-4520-97ed-876b7320c069/documents/4bfe5a87-8ac1-43e4-aace-68c8dc6b6c92_95127113-3c81-40a0-b03c-f47881e4aeb4.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-vinylpyridine,100-69-6,"Several repeated dose oral toxicity studies on 2VP in rats are available which suggest a systemic NOAEL between 20 and 50 mg/kg bw/d. There is no evidence of specific target organ toxicity; rather only signs of generalized toxicity such as changes in food consumption, altered body weight gain, and changes in relative organ weights. Concerning local effects, 2VP displayed corrosive effects at the portal of entry, the nonglandular stomach. The LOAEL for this effect was 20 mg/kg bw/d in the 90-day study. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93381c79-1f91-4ede-8813-477c39485bc1/documents/IUC5-1b8574be-0fe2-4854-91d9-506c07b869b7_f8527fbf-e476-47d9-a3f3-03f9e386ec39.html,,,,,, 2-vinylpyridine,100-69-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93381c79-1f91-4ede-8813-477c39485bc1/documents/IUC5-1b8574be-0fe2-4854-91d9-506c07b869b7_f8527fbf-e476-47d9-a3f3-03f9e386ec39.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat 2-vinylpyridine,100-69-6,"The oral LD50 of 2-vinylpyridine in rats is 336 mg/kg body weight (bw), and when 2-VP is applied dermally to rabbits under occlusive dressings, the LD50 value is 640 mg/kg bw. As there are no accepted methods of extrapolating from lethal values in animals to ""no effect"" levels in humans, the risk assessment will be qualitative. Risk management measures in place for skin and eye corrosion will protect against acute dermal toxicity in humans. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93381c79-1f91-4ede-8813-477c39485bc1/documents/IUC5-106b5ff2-92ef-443c-9dbd-f8f0a2700000_f8527fbf-e476-47d9-a3f3-03f9e386ec39.html,,,,,, 2-vinylpyridine,100-69-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93381c79-1f91-4ede-8813-477c39485bc1/documents/IUC5-106b5ff2-92ef-443c-9dbd-f8f0a2700000_f8527fbf-e476-47d9-a3f3-03f9e386ec39.html,,oral,LD50,336 mg/kg bw,, 2-vinylpyridine,100-69-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93381c79-1f91-4ede-8813-477c39485bc1/documents/IUC5-106b5ff2-92ef-443c-9dbd-f8f0a2700000_f8527fbf-e476-47d9-a3f3-03f9e386ec39.html,,dermal,LD50,650 mg/kg bw,, 3-((1R)-2-chloro-1-hydroxyethyl)phenol,925430-39-3,"An oral LD50 between >2000 mg/kg bw was determined in an acute oral toxicity study (OECD 423, GLP). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1410594-559e-4959-8c46-ec5840eca36e/documents/IUC5-36b51845-3f2c-45ea-ab86-6f33fd47c79a_6421f03e-3e2f-4c66-ab49-5259b58a83b9.html,,,,,, N-(p-toluenesulfonyl)-N'-(3-(p-toluenesulfonyloxy)phenyl)urea,232938-43-1,"Valid repeated dose toxicity studies with the test substance are available. In a 5 day oral range finding study (no guideline followed), the lowest dose level of 200 mg/kg bw/d was established as LOAEL (rats, RCC743523, 1999). In a follow up 28 day subacute oral toxicity study conducted according to OECD guideline 407 the NOAEL was 30 mg/kg bw/d (rats, RCC 743512, 2000). In a 90 day subchronic oral toxicity study conducted according to OECD guideline 408 the NOAEL was 50 mg/kg bw/d (rats, RCC835424, 2002). Based on the results of these studies the NOAEL of 50 mg/kg bw/d was used as key value for chemical assessment. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5786ea92-d756-473b-8ed4-801af3a33ab8/documents/IUC5-c3f1323c-ee07-4cd5-b5ac-fc093750274c_d6d596a5-7cda-47f7-873c-ecaf4d88c003.html,,,,,, N-(p-toluenesulfonyl)-N'-(3-(p-toluenesulfonyloxy)phenyl)urea,232938-43-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5786ea92-d756-473b-8ed4-801af3a33ab8/documents/IUC5-c3f1323c-ee07-4cd5-b5ac-fc093750274c_d6d596a5-7cda-47f7-873c-ecaf4d88c003.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat N-(p-toluenesulfonyl)-N'-(3-(p-toluenesulfonyloxy)phenyl)urea,232938-43-1,"Valid acute toxicity studies with the test substance are available for the oral and the dermal route. In a study conducted according to OECD guideline 423 the oral LD 50 was greater than 2000 mg/kg bw (rat, RCC743477, 1999). In a study conducted according to OECD guideline 402 the dermal LD 50 was greater than 2000 mg/kg bw (rat, RCC743488, 1999). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5786ea92-d756-473b-8ed4-801af3a33ab8/documents/IUC5-40e3e7d3-262d-4273-bec7-31017a7dd5ad_d6d596a5-7cda-47f7-873c-ecaf4d88c003.html,,,,,, N-(p-toluenesulfonyl)-N'-(3-(p-toluenesulfonyloxy)phenyl)urea,232938-43-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5786ea92-d756-473b-8ed4-801af3a33ab8/documents/IUC5-40e3e7d3-262d-4273-bec7-31017a7dd5ad_d6d596a5-7cda-47f7-873c-ecaf4d88c003.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, N-(p-toluenesulfonyl)-N'-(3-(p-toluenesulfonyloxy)phenyl)urea,232938-43-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5786ea92-d756-473b-8ed4-801af3a33ab8/documents/IUC5-40e3e7d3-262d-4273-bec7-31017a7dd5ad_d6d596a5-7cda-47f7-873c-ecaf4d88c003.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-(1-(4-amino-3-methyl-5-sulphonatophenyl)-1-(4-amino-3-sulphonatophenyl)methylene)cyclohexa-1,4-dienesulphonic acid",3244-88-0," Acute oral toxicity LD50 was estimated to be 4137.6mg/kg bw when male and female Wistar rats were exposed with 2-amino-5-[(4-amino-3-sulfonatophenyl)(3-sulfocyclohexa-2,5-dien-1-ylidene)methyl]-3-methylbenzenesulfonate (3244-88-0)orally. Acute dermal toxicity LD50 was estimated to be 8934.39 mg/kg bw. When male and female New Zealand White rabbits were exposed with 2-amino-5-[(4-amino-3-sulfonatophenyl)(3-sulfocyclohexa-2,5-dien-1-ylidene)methyl]-3-methylbenzenesulfonate (3244-88-0)by dermal application. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d07d870-c76e-4742-af19-02dd8791c2c5/documents/08c7d80b-8639-48f7-bb23-d13a17ec45db_81022c45-8461-42b8-b235-1634f37e3fc7.html,,,,,, "3-(1-(4-amino-3-methyl-5-sulphonatophenyl)-1-(4-amino-3-sulphonatophenyl)methylene)cyclohexa-1,4-dienesulphonic acid",3244-88-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d07d870-c76e-4742-af19-02dd8791c2c5/documents/08c7d80b-8639-48f7-bb23-d13a17ec45db_81022c45-8461-42b8-b235-1634f37e3fc7.html,,oral,LD50,"4,137.6 mg/kg bw",no adverse effect observed, "3-(1-(4-amino-3-methyl-5-sulphonatophenyl)-1-(4-amino-3-sulphonatophenyl)methylene)cyclohexa-1,4-dienesulphonic acid",3244-88-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d07d870-c76e-4742-af19-02dd8791c2c5/documents/08c7d80b-8639-48f7-bb23-d13a17ec45db_81022c45-8461-42b8-b235-1634f37e3fc7.html,,dermal,LD50,"8,934.39 mg/kg bw",no adverse effect observed, 3-(1-ethoxyethyl)-5-methyl-oxazolidin-2-one,123403-95-2," LD50 (oral, rat): > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88a5b453-0622-4371-b535-88c1ec1218d9/documents/db09cfda-772a-4584-b539-9209a893901e_62f08216-8a34-46c1-8a14-f824a02de2da.html,,,,,, 3-(1-ethoxyethyl)-5-methyl-oxazolidin-2-one,123403-95-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88a5b453-0622-4371-b535-88c1ec1218d9/documents/db09cfda-772a-4584-b539-9209a893901e_62f08216-8a34-46c1-8a14-f824a02de2da.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-(1H-benzimidazol-2-yl)-7-(diethylamino)-2-benzopyrone,27425-55-4,Estimated LD50 was considered to be 2696.239257813 mg/kg bw for Sprague-Dawley male and female rats ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51bae1a4-5cf5-497a-8272-2602668a0727/documents/IUC5-77011270-27aa-4946-b5eb-82612d2117de_135ccdf5-bb1b-428b-b32d-86bacc706028.html,,,,,, 3-(1H-benzimidazol-2-yl)-7-(diethylamino)-2-benzopyrone,27425-55-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51bae1a4-5cf5-497a-8272-2602668a0727/documents/IUC5-77011270-27aa-4946-b5eb-82612d2117de_135ccdf5-bb1b-428b-b32d-86bacc706028.html,,oral,LD50,"2,696.239 mg/kg bw",no adverse effect observed, "3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate",178452-66-9,NOAEL >= 1000 mg/kg bw/day ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a91b276-9488-40f2-8838-31fb5248ec2d/documents/1a7be29d-05d3-4f11-af46-e992a298ca6c_26ccd131-302a-4156-ae54-e96cdb86717c.html,,,,,, "3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate",178452-66-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a91b276-9488-40f2-8838-31fb5248ec2d/documents/1a7be29d-05d3-4f11-af46-e992a298ca6c_26ccd131-302a-4156-ae54-e96cdb86717c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate",178452-66-9,The LD 50 of the test substance for the acute oral toxicity is greater than 2000 mg/kg bw.The LD 50 of the test substance for the acute dermal toxicity is greater than 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a91b276-9488-40f2-8838-31fb5248ec2d/documents/6955216b-2e54-49c7-8159-bd382ac34baf_26ccd131-302a-4156-ae54-e96cdb86717c.html,,,,,, "3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate",178452-66-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a91b276-9488-40f2-8838-31fb5248ec2d/documents/6955216b-2e54-49c7-8159-bd382ac34baf_26ccd131-302a-4156-ae54-e96cdb86717c.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "3-(2,4-bis(4-((5-(4,6-bis(2-aminopropylamino)-1,3,5-triazin-2-ylamino)-4-hydroxy-2,7-disulfonaphthalen-3-yl)azo)phenylamino)-1,3,5-triazin-6-ylamino)propyldiethylammonium lactate",178452-66-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a91b276-9488-40f2-8838-31fb5248ec2d/documents/6955216b-2e54-49c7-8159-bd382ac34baf_26ccd131-302a-4156-ae54-e96cdb86717c.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 3-(2-dodecenyl)succinic anhydride,19780-11-1,"The test substance treatment via the gavage route showed primarily damage to the non-glandular stomach (forestomach) in rats, which stores and digests food. This affected digestion and led to a disturbance in the energy conversion cycle, as revealed by the decrease in glucose, proteins, and lipids markers in the serum. The local effects in the forestomach also possibly led to a decrease in body weight without affecting food consumption and also a reduction in the size of multiple organs, including lesions in a few organs (seminal vesicles and thymus). Stress induced by these concomitant effects led to adrenal cortical hypertrophy. All these sequential effects were less pronounced at the mid-dose level (270 mg/kg bw/day) and negligible at the low-dose level (90 mg/kg bw/day). However, the observed effects were not considered relevant for humans as non-glandular stomachs are not present in human beings. Under the study conditions, NOAEL was determined at the lowest dose 90 mg/kg bw/day.   ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfa28c04-e5ee-4487-96da-147ed9a6898e/documents/05fe13d9-20e9-4b84-b24e-151df6fbe061_b36681c3-7215-4b7b-87c3-94d741ea09c7.html,,,,,, 3-(2-dodecenyl)succinic anhydride,19780-11-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfa28c04-e5ee-4487-96da-147ed9a6898e/documents/05fe13d9-20e9-4b84-b24e-151df6fbe061_b36681c3-7215-4b7b-87c3-94d741ea09c7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,90 mg/kg bw/day,,rat 3-(2-dodecenyl)succinic anhydride,19780-11-1,"Based on the oral, dermal and inhalation LD(C)50 values, the test substance is considered to have a low acute toxicity potential.  ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfa28c04-e5ee-4487-96da-147ed9a6898e/documents/1c990978-ac19-4bcc-9294-8368e9111f87_b36681c3-7215-4b7b-87c3-94d741ea09c7.html,,,,,, 3-(2-dodecenyl)succinic anhydride,19780-11-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfa28c04-e5ee-4487-96da-147ed9a6898e/documents/1c990978-ac19-4bcc-9294-8368e9111f87_b36681c3-7215-4b7b-87c3-94d741ea09c7.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 3-(2-dodecenyl)succinic anhydride,19780-11-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfa28c04-e5ee-4487-96da-147ed9a6898e/documents/1c990978-ac19-4bcc-9294-8368e9111f87_b36681c3-7215-4b7b-87c3-94d741ea09c7.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 3-(2-dodecenyl)succinic anhydride,19780-11-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfa28c04-e5ee-4487-96da-147ed9a6898e/documents/1c990978-ac19-4bcc-9294-8368e9111f87_b36681c3-7215-4b7b-87c3-94d741ea09c7.html,,inhalation,LC50,> 5.3 mg/L,no adverse effect observed, 3-(2-methoxy-5-methylphenyl)-3-phenylpropanoic acid,109089-77-2, Acute oral toxicity: Key study: OECD 423 and EU method B.1 tris. GLP study. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off of the test item may be considered to be higher than 5000 mg/kg body weight by oral route in the rat. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff973ff6-9374-4bd2-b334-0b910d51f058/documents/d19dd1a4-8caa-43bb-8ddd-c68cace5a485_8f65b731-84d8-43c3-927f-062410f3c556.html,,,,,, 3-(2-methoxy-5-methylphenyl)-3-phenylpropanoic acid,109089-77-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff973ff6-9374-4bd2-b334-0b910d51f058/documents/d19dd1a4-8caa-43bb-8ddd-c68cace5a485_8f65b731-84d8-43c3-927f-062410f3c556.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3-(3,5-di-tert-butyl-4-hydroxyphenyl)-N-octadecylpropanamide",14442-94-5,"The acute oral, female rat study; LD50 > 2000 mg / kg bwThe acute dermal rat male/female; LD50 >2000 mg / kg bw ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f9a6806-cd2c-4544-a71b-d581e6f794bb/documents/IUC5-9d157d92-6fbe-4549-9658-86e0dff5db08_232b434c-d680-4502-8b64-f0847ecdf72f.html,,,,,, 3-(3-hydroxypropyl)oxazolidin-2-one,87010-29-5,"Oral: subacute NOAEL: 285 mg/kg bw/day (OECD guideline 407, BASF AG 2004) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a61d3af-c266-42fe-9600-a2e0ca07c0af/documents/IUC5-a03ce9b2-8f58-4f10-b485-9694a75458f0_237ed978-8f20-47c6-9605-701ea1b78491.html,,,,,, 3-(3-hydroxypropyl)oxazolidin-2-one,87010-29-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a61d3af-c266-42fe-9600-a2e0ca07c0af/documents/IUC5-a03ce9b2-8f58-4f10-b485-9694a75458f0_237ed978-8f20-47c6-9605-701ea1b78491.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,285 mg/kg bw/day,,rat 3-(3-hydroxypropyl)oxazolidin-2-one,87010-29-5,"acute oral toxicity, LD50 >5110 mg/kg bw (OECD guideline 401) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a61d3af-c266-42fe-9600-a2e0ca07c0af/documents/IUC5-6b7d71f8-2bf1-4eca-9fa8-7ddc08e5f578_237ed978-8f20-47c6-9605-701ea1b78491.html,,,,,, 3-(3-hydroxypropyl)oxazolidin-2-one,87010-29-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a61d3af-c266-42fe-9600-a2e0ca07c0af/documents/IUC5-6b7d71f8-2bf1-4eca-9fa8-7ddc08e5f578_237ed978-8f20-47c6-9605-701ea1b78491.html,,oral,LD50,"5,110 mg/kg bw",, 3-(3-tert-butyl-4-hydroxyphenyl)propionic acid,107551-67-7,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/10b45893-f7ae-4e89-afe1-5416322e12b0/documents/IUC5-1ce6e42c-ebf6-4940-97cf-91200e22f51b_f57e9d7a-e3b1-4b8b-a4e3-85918fadef20.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 3-(3-tert-butyl-4-hydroxyphenyl)propionic acid,107551-67-7,"A single dose of 2000 mg/kg bw of the test substance was administrated dermal to groups of male and female rats (5/sex, OECD guideline 402). Application of the test substance did not induce any sings of toxicity. None of the animals died, viability and bodyweight gain were unaffected by the test article. However, single oral administration of the test item (OECD 401) to rats leads to dyspnoe, reduced spontaneous activity and hunched posture. All female animals of the high dose group (2000 mg/kg bw) died until day 3 of the post observation period. LD50 after single dermal administration is 2000 mg/kg bw, after single oral administration 1000 mg/kg bw. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10b45893-f7ae-4e89-afe1-5416322e12b0/documents/IUC5-8762cd98-cebf-4784-a2bf-ff5b9d76c2f0_f57e9d7a-e3b1-4b8b-a4e3-85918fadef20.html,,,,,, 3-(3-tert-butyl-4-hydroxyphenyl)propionic acid,107551-67-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10b45893-f7ae-4e89-afe1-5416322e12b0/documents/IUC5-8762cd98-cebf-4784-a2bf-ff5b9d76c2f0_f57e9d7a-e3b1-4b8b-a4e3-85918fadef20.html,,oral,LD50,"1,000 mg/kg bw",, 3-(3-tert-butyl-4-hydroxyphenyl)propionic acid,107551-67-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10b45893-f7ae-4e89-afe1-5416322e12b0/documents/IUC5-8762cd98-cebf-4784-a2bf-ff5b9d76c2f0_f57e9d7a-e3b1-4b8b-a4e3-85918fadef20.html,,dermal,LD50,"2,000 mg/kg bw",, "3-(4,4-dimethylcyclohex-1-en-1-yl)propanal",850997-10-3," Oral: NOAEL (rat (male/female) = 150 mg/kg bw/day, (oral gavage to rats; corn oil vehicle : 0 (control), 75, 150, and 300mg/kg/day), Repeated dose 28-day oral study with 14-day recovery, OECD TG 407, GLP. 2010 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4ef5261-a0aa-4d47-9459-537e6be492c7/documents/454583ca-5dbf-4c28-9110-b7d963c5f772_bafbc187-21b4-467b-b07e-93354d68dc81.html,,,,,, "3-(4,4-dimethylcyclohex-1-en-1-yl)propanal",850997-10-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4ef5261-a0aa-4d47-9459-537e6be492c7/documents/454583ca-5dbf-4c28-9110-b7d963c5f772_bafbc187-21b4-467b-b07e-93354d68dc81.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "3-(4,4-dimethylcyclohex-1-en-1-yl)propanal",850997-10-3," Oral: LD50 > 300 - < 2000 mg/kg bw, female rat, OECD TG 420, 2009 Inhalation: LC50 >1 - ≤ 5 mg/L, female rat, OECD TG 436, 2012 Dermal: measured LD50 > 2000 mg/kg bw and the estimated LD50 cut-off value was considered to be > 5000 mg/kg bw, male/female rat, OECD TG 402, 2010 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4ef5261-a0aa-4d47-9459-537e6be492c7/documents/0287cec7-014d-4fbb-8976-1c0795a12fbe_bafbc187-21b4-467b-b07e-93354d68dc81.html,,,,,, "3-(4,4-dimethylcyclohex-1-en-1-yl)propanal",850997-10-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4ef5261-a0aa-4d47-9459-537e6be492c7/documents/0287cec7-014d-4fbb-8976-1c0795a12fbe_bafbc187-21b4-467b-b07e-93354d68dc81.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, "3-(4,4-dimethylcyclohex-1-en-1-yl)propanal",850997-10-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4ef5261-a0aa-4d47-9459-537e6be492c7/documents/0287cec7-014d-4fbb-8976-1c0795a12fbe_bafbc187-21b4-467b-b07e-93354d68dc81.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3-(4,4-dimethylcyclohex-1-en-1-yl)propanal",850997-10-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4ef5261-a0aa-4d47-9459-537e6be492c7/documents/0287cec7-014d-4fbb-8976-1c0795a12fbe_bafbc187-21b4-467b-b07e-93354d68dc81.html,,inhalation,LC50,"1,000 mg/m3",adverse effect observed, "3-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl)-2,2-dimethylpropanenitrile",2003244-43-5, The acute oral median lethal dose (LD50) of ES421 Pinyl Nitrile in the Wistar strain rat was found to be greater than 2000 mg/kg body weight according to OECD Test Guideline 423 using the acute oral toxicity method. The acute inhalation median lethal concentration (4 hour LC50) of the test item ES421 Pinyl Nitrile in the Wistar strain rat was greater than a mean maximum attainable atmosphere concentration of 4.28 mg/L according to OECD Test Guideline 403 using the acute inhalation toxicity (nose only) method. The acute dermal median lethal dose (LD50) of ES421 Pinyl Nitril in the Wistar strain rat was found to be greater than 2000 mg/kg body weight according to OECD Test Guideline 402 using the acute dermal toxicity method. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fbfdc721-ce8e-4c4e-9dff-8a2899c201d4/documents/7632c71d-f7d0-4dc6-9bd2-578ad103e64d_4b51a476-3174-47a8-a71e-71045dff9fee.html,,,,,, "3-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl)-2,2-dimethylpropanenitrile",2003244-43-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fbfdc721-ce8e-4c4e-9dff-8a2899c201d4/documents/7632c71d-f7d0-4dc6-9bd2-578ad103e64d_4b51a476-3174-47a8-a71e-71045dff9fee.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl)-2,2-dimethylpropanenitrile",2003244-43-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fbfdc721-ce8e-4c4e-9dff-8a2899c201d4/documents/7632c71d-f7d0-4dc6-9bd2-578ad103e64d_4b51a476-3174-47a8-a71e-71045dff9fee.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl)-2,2-dimethylpropanenitrile",2003244-43-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fbfdc721-ce8e-4c4e-9dff-8a2899c201d4/documents/7632c71d-f7d0-4dc6-9bd2-578ad103e64d_4b51a476-3174-47a8-a71e-71045dff9fee.html,,inhalation,LC50,"4,280 mg/m3",no adverse effect observed, "3-(allyloxy)propane-1,2-diol",123-34-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/667da563-8631-457d-9575-c65158fe14a9/documents/4fb4b221-6fce-4f14-ab8b-d68e290ee77f_70985bb1-5ed2-4ac4-bdd3-fa23597ab525.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-(amidinothio)propionic acid,5398-29-8,"In an acute toxic class test an oral LD50 above 200 and below or equal to 2000 mg/kg bw was determined in rats (BASF SE, 1999). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3de1a9d7-05fe-49c3-b8b2-46b2575845b9/documents/IUC5-55f73be0-1681-46b5-a604-580b6d29df99_cb2507c4-6228-4e62-bd16-6a572f523704.html,,,,,, 3-(amidinothio)propionic acid,5398-29-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3de1a9d7-05fe-49c3-b8b2-46b2575845b9/documents/IUC5-55f73be0-1681-46b5-a604-580b6d29df99_cb2507c4-6228-4e62-bd16-6a572f523704.html,,oral,LD50,200 mg/kg bw,adverse effect observed, 3-(benzothiazol-2-yl)-7-(diethylamino)-2-oxo-2H-1-benzopyran-4-carbonitrile,70546-25-7,"Acute Oral Toxicity: OECD TG 401, EU Method B.1, GLP, 5 rats/sex, single oral dose via gavage, 14 d observation, limit test, 2000 mg/kg bw; Results: LD50: > 2000 mg/kg bw/day.  ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5e3630b-9a5b-46b9-9fe5-1a824a9ccc4b/documents/c0740d1b-381d-48e8-a90f-f68c4456a243_190bea9c-af3e-41cb-bbbd-0671c32e6054.html,,,,,, 3-(benzothiazol-2-yl)-7-(diethylamino)-2-oxo-2H-1-benzopyran-4-carbonitrile,70546-25-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5e3630b-9a5b-46b9-9fe5-1a824a9ccc4b/documents/c0740d1b-381d-48e8-a90f-f68c4456a243_190bea9c-af3e-41cb-bbbd-0671c32e6054.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 3-(chlorodimethylsilyl)propyl methacrylate,24636-31-5," There are no reliable acute toxicity data for 3-(chlorodimethylsilyl)propyl methacrylate. However, in accordance with Column 2 of REACH Annex VII, acute toxicity studies (required in Section 8.5) do not need to be conducted as the substance is classified as corrosive to skin. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7994f672-a8f7-4496-99ef-aedb3abaf0ec/documents/04a64d70-fc03-4998-bd20-8bb6f20b2469_9c833b17-91d7-466d-ab06-16769dcd8d71.html,,,,,, 3-(chloromethyl)heptane,123-04-6,"LD50, rat, oral: > 5653 mg/kg bw (BASF AG, 1970). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcd4076f-67a6-4aad-b477-1265da8ca6ad/documents/IUC5-a85b52c8-664f-48ff-a78f-c5f3191bbe2d_51c2ba6e-97b2-4d7d-9437-414b0ce22d7c.html,,,,,, 3-(diethoxymethylsilyl)propylamine,3179-76-8,"There are no repeated dose studies on 3-(Diethoxymethylsilyl)propylamine (CAS: 3179-76-8 EC: 221-660-8). However, a testing proposal for a repeated dose toxicity study in rats according to OECD Test Guideline 408 and in compliance with GLP with the registered substance is included for consideration by ECHA. Good quality data for the related substance 3-aminopropyltriethoxysilane (CAS 919-30-2) is available as an interim measure until the test is conducted.     The available key 90-day oral (gavage) repeated dose toxicity study in male and female rats, was conducted according to OECD Test Guideline 408 and in compliance with GLP on an analogue substance, 3-aminopropyltriethoxysilane (919-30-2). This study identified a NOAEL value of 200 mg/kg bw/day, with mortality, clinical findings and liver effects at the LOAEL of 600 mg/kg bw/day (WIL Research Laboratories, 2001, reliability 1).   This NOAEL was in agreement with the NOAEL derived from the oral 28-day study in which the hydrolysis product of 3-(diethoxymethylsilyl)propylamine, 3-aminopropyl(methyl)silanediol, was tested. In this study there were no adverse effects up to a maximum dose of 200 mg/kg bw/day in rats (Chemicals Evaluation and Research Institute 2003, reliability 1). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/befd192b-612b-4466-8106-9e778567da68/documents/270b8466-5d83-44a9-886c-ce730fa3d64b_683b64ba-5b09-4e95-9d62-ed840b74bcb1.html,,,,,, 3-(diethoxymethylsilyl)propylamine,3179-76-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/befd192b-612b-4466-8106-9e778567da68/documents/270b8466-5d83-44a9-886c-ce730fa3d64b_683b64ba-5b09-4e95-9d62-ed840b74bcb1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat 3-(diethoxymethylsilyl)propylamine,3179-76-8,"In an acute oral toxicity study conducted according to the now deleted OECD Test Guideline 401, but not in compliance with GLP, the LD50 value for 3-(diethoxymethylsilyl)propylamine (CAS: 3179-76-8 EC: 221-660-8) in male and female rats was concluded to be higher than 2000 mg/kg bw (Hüls AG, 1989, reliability 2). In an acute dermal toxicity study with limited information, which had been conducted in a manner similar to the now deleted OECD Test Guideline 402 with acceptable restrictions, and not in compliance with GLP, the LD50 for 3-(diethoxymethylsilyl)propylamine (CAS: 3179-76-8 EC: 221-660-8) was concluded to be 2.52 ml/kg bw (2293 mg/kg bw based on a relative density of 0.91) in male rabbits. Corrosive effects on the skin were apparent (Mellon Institute, 1956, reliability 2). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/befd192b-612b-4466-8106-9e778567da68/documents/18450e5b-d527-44b3-93bd-8e9fea3ada4a_683b64ba-5b09-4e95-9d62-ed840b74bcb1.html,,,,,, 3-(diethoxymethylsilyl)propylamine,3179-76-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/befd192b-612b-4466-8106-9e778567da68/documents/18450e5b-d527-44b3-93bd-8e9fea3ada4a_683b64ba-5b09-4e95-9d62-ed840b74bcb1.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, 3-(diethoxymethylsilyl)propylamine,3179-76-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/befd192b-612b-4466-8106-9e778567da68/documents/18450e5b-d527-44b3-93bd-8e9fea3ada4a_683b64ba-5b09-4e95-9d62-ed840b74bcb1.html,,dermal,LD50,"2,293 mg/kg bw",adverse effect observed, 3-(dimethoxymethylsilyl)propanethiol,31001-77-1,"No acute toxicity studies are available for the registered substance. 3-(dimethoxymethylsilyl)propanethiol. Data are therefore read across from the structural analogue, 3-(trimethoxysilyl)propane-1-thiol. The following key studies are available for the acute toxicity of  3-(trimethoxysilyl)propane-1-thiol (CAS RN: 4420-74-0; EC Nr: 224-588-5): The key study for acute oral toxicity (Eurofins, 2018a, reliability 1) was conducted according to OECD Test Guideline 423 and in compliance with GLP. The acute oral LD50 was identified to be 500 mg/kg bw for female rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a371ec12-faef-4a88-b148-c91ed8eebc77/documents/IUC5-1dd81078-60ea-4177-bad9-193acf6b56dd_a01109e6-72ad-4b92-abfa-fee05aa9d7dd.html,,,,,, 3-(dimethoxymethylsilyl)propanethiol,31001-77-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a371ec12-faef-4a88-b148-c91ed8eebc77/documents/IUC5-1dd81078-60ea-4177-bad9-193acf6b56dd_a01109e6-72ad-4b92-abfa-fee05aa9d7dd.html,,oral,LD50,500 mg/kg bw,adverse effect observed, 3-(dimethoxymethylsilyl)propyl methacrylate,14513-34-9," The key acute oral toxicity studies were read across from the analogous substances 3-(trimethoxysilylpropyl) methacrylate (CAS 2530-85-0) and [dimethoxy(methyl)silyl]methyl methacrylate (CAS 121177-93-3). The LD50 values were reported to be >2000 mg/kg for both substances (Dow Corning Corporation, 2001; Bioservice, 2003a). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fdb7d7ab-c5a1-40a3-afad-1a4ec7e18d0e/documents/b9dbfc81-ea8d-4945-aa56-46ca5bfcba87_5f59482b-9cef-4533-8318-4ff9de697a29.html,,,,,, 3-(dimethoxymethylsilyl)propyl methacrylate,14513-34-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fdb7d7ab-c5a1-40a3-afad-1a4ec7e18d0e/documents/b9dbfc81-ea8d-4945-aa56-46ca5bfcba87_5f59482b-9cef-4533-8318-4ff9de697a29.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-(dimethylamino)propylurea,31506-43-1," 200 mg/kg was the No-Observed-Adverse-Effect-Level (NOAEL) for 3-(Dimethylamino)propylurea when administered to rats by oral gavage for 28 days. Minimal effects were seen at a dose of 1000 mg/kg/day. (OECD 407) Bayer 1986 The ""No Observed Effect Level (NOEL) was, therefore, considered to be 500 mg/kg/day. (OECD 407) MB Research ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5f7d4e73-5475-4bd4-acde-8066e62d01ac/documents/45add040-8fbe-4894-bc9e-4c68f14e9b17_4ce840f4-7804-4c10-a6e4-d67652f96c1b.html,,,,,, 3-(dimethylamino)propylurea,31506-43-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5f7d4e73-5475-4bd4-acde-8066e62d01ac/documents/45add040-8fbe-4894-bc9e-4c68f14e9b17_4ce840f4-7804-4c10-a6e4-d67652f96c1b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat 3-(dimethylamino)propylurea,31506-43-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP study, no other available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): GLP study, no other available. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f7d4e73-5475-4bd4-acde-8066e62d01ac/documents/a7a2e01d-86e1-405a-8ec3-cbc82a1fc9df_4ce840f4-7804-4c10-a6e4-d67652f96c1b.html,,,,,, 3-(dimethylamino)propylurea,31506-43-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f7d4e73-5475-4bd4-acde-8066e62d01ac/documents/a7a2e01d-86e1-405a-8ec3-cbc82a1fc9df_4ce840f4-7804-4c10-a6e4-d67652f96c1b.html,,oral,LD50,"5,125 mg/kg bw",no adverse effect observed, 3-(dimethylamino)propylurea,31506-43-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f7d4e73-5475-4bd4-acde-8066e62d01ac/documents/a7a2e01d-86e1-405a-8ec3-cbc82a1fc9df_4ce840f4-7804-4c10-a6e4-d67652f96c1b.html,,dermal,LD50,"2,050 mg/kg bw",no adverse effect observed, 3-(Hydroxymethyl)-1-pentene,53045-70-8,"The informtion for this endpoint study record was obtained from an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 407. Daily oral treatment with 100, 300 and 1000 mg/kg the test material  to Wistar (Han) rats was clinically tolerated over 28 days. The No Observed Adverse Effect Level (NOAEL) in Wistar (Han) rats was established at 300 mg/kg/d. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The information for this endpoint study record was obtained from an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 407 . ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8ebd75e-cd77-4131-b952-8d48ea1a0514/documents/56b3777d-ae98-4eeb-a92d-4c79f1fc78e6_46e90101-2eda-4516-9c51-f4869d4537f7.html,,,,,, 3-(Hydroxymethyl)-1-pentene,53045-70-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8ebd75e-cd77-4131-b952-8d48ea1a0514/documents/56b3777d-ae98-4eeb-a92d-4c79f1fc78e6_46e90101-2eda-4516-9c51-f4869d4537f7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 3-(Hydroxymethyl)-1-pentene,53045-70-8,"The test item was tested for acute toxicity in rats after oral administration of 300 and 2000 mg/kg body weight. The rats treated with 300 mg/kg survived until the end of the observation period, whereas all rats treated with 2000 mg/kg died 50 minutes up to 23 hours after dosing. Signs of toxicity were seen in the rats treated with 300 mg/kg immediately after oral administration up to 60 minutes. They consisted of locomotor disturbance, dyspnoea, and one female rat showed abdominal position. According to the results of this study with the test item, the LD50 value was determined to be between 300 – 2000 mg/kg falling into category 4 based on GHS criteria. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8ebd75e-cd77-4131-b952-8d48ea1a0514/documents/9ae05791-2bf1-4a86-a96a-62024dc7b3b6_46e90101-2eda-4516-9c51-f4869d4537f7.html,,,,,, 3-(Hydroxymethyl)-1-pentene,53045-70-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8ebd75e-cd77-4131-b952-8d48ea1a0514/documents/9ae05791-2bf1-4a86-a96a-62024dc7b3b6_46e90101-2eda-4516-9c51-f4869d4537f7.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, 3-(isodecyloxy)propiononitrile,64354-92-3, The oral LD50 of Ethernitril-C10i is above 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4adbb63b-2be4-432f-877d-fe5d4af85d0c/documents/2fe39409-0f1f-4907-b0e9-ad44628da45b_8542ecb2-ab25-4ab9-bf38-27298badb93f.html,,,,,, 3-(methylthio)propionaldehyde,3268-49-3," Oral (similar to OECD 407), rat (m/f): NOAEL systemic = 103.6 mg/kg bw/day Inhalation (9 days study), rat (m/ f): Vapor aerosol NOAEC systemic = 217.4 mg/m3 air, corresponding to 50.5 ppm Dermal (9 days study, similar to OECD 410), rat (m/f): NOAEL systemic = 527 mg/kg bw/day Dermal (9 days study, similar to OECD 410), rat (m/f): NOAEL local = 210.8 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/508391dd-30b3-485f-af0e-3002430c883a/documents/IUC5-4f2259dc-ce2d-4cef-aff4-29bab81943ae_221a271b-e501-4892-bb15-9d907c768d93.html,,,,,, 3-(methylthio)propionaldehyde,3268-49-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/508391dd-30b3-485f-af0e-3002430c883a/documents/IUC5-4f2259dc-ce2d-4cef-aff4-29bab81943ae_221a271b-e501-4892-bb15-9d907c768d93.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,103.6 mg/kg bw/day,,rat 3-(methylthio)propionaldehyde,3268-49-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/508391dd-30b3-485f-af0e-3002430c883a/documents/IUC5-4f2259dc-ce2d-4cef-aff4-29bab81943ae_221a271b-e501-4892-bb15-9d907c768d93.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,527 mg/kg bw/day,,rat 3-(methylthio)propionaldehyde,3268-49-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/508391dd-30b3-485f-af0e-3002430c883a/documents/IUC5-4f2259dc-ce2d-4cef-aff4-29bab81943ae_221a271b-e501-4892-bb15-9d907c768d93.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,217.4 mg/m3,,rat 3-(methylthio)propionaldehyde,3268-49-3," Oral (similar to OECD 401), rat (m): LD50 = 490 mg/kg bw Inhalation (similar to OECD 403), rat (m, f): LC50 = 4.8 mg/L air Dermal (similar to OECD 402), rabbit (m, f): LD50 = 736 mg/kg bw (males) and 818 mg/kg bw (females) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/508391dd-30b3-485f-af0e-3002430c883a/documents/IUC5-ff7f2ece-502b-494f-9412-5feba932bcc3_221a271b-e501-4892-bb15-9d907c768d93.html,,,,,, 3-(methylthio)propionaldehyde,3268-49-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/508391dd-30b3-485f-af0e-3002430c883a/documents/IUC5-ff7f2ece-502b-494f-9412-5feba932bcc3_221a271b-e501-4892-bb15-9d907c768d93.html,,oral,LD50,490 mg/kg bw,adverse effect observed, 3-(methylthio)propionaldehyde,3268-49-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/508391dd-30b3-485f-af0e-3002430c883a/documents/IUC5-ff7f2ece-502b-494f-9412-5feba932bcc3_221a271b-e501-4892-bb15-9d907c768d93.html,,dermal,LD50,736 mg/kg bw,adverse effect observed, 3-(methylthio)propionaldehyde,3268-49-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/508391dd-30b3-485f-af0e-3002430c883a/documents/IUC5-ff7f2ece-502b-494f-9412-5feba932bcc3_221a271b-e501-4892-bb15-9d907c768d93.html,,inhalation,LC50,4.8 mg/m3,adverse effect observed, "3-(N-p-methoxy cinnamidopropyl-N,N-dimethyl ammonium)-2-hydroxypropane-1-sulphonate",500731-87-3," Oral:The objective of the study was to determine the acute oral toxicity of ""Galaxy-Sunbeat (S-382)"" to albino mice following the Gaitonde Committee protocol. The LD50 value of ""Galaxy-Sunbeat (S-382)"" according to the Gaitonde Commitee Guidelines, in albino mice by the oral route, following the methods of Litchfield and Wilcoxon (1949) was found to be greater than 5.0 ml/kg (5000 mg/kg bw). Dermal: The objective of the study reported was to determine the acute dermal toxicity of Galaxy Sunbeat MM-30 in rabbits, following the Gaitonde Committee Protocol. The LD50 value of the test material GALAXY-SUNBETAINE-MM-30  was found to be greater than 5.00 ml/kg (5000 mg/kg bw). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ec44ad7-da0e-4c9d-9322-7cd00df7bd9d/documents/IUC5-4ac272d7-ca5e-4a54-b338-32691fa8237b_b2f3b143-5527-46bc-a8af-dba9c8114e4c.html,,,,,, "3-(N-p-methoxy cinnamidopropyl-N,N-dimethyl ammonium)-2-hydroxypropane-1-sulphonate",500731-87-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ec44ad7-da0e-4c9d-9322-7cd00df7bd9d/documents/IUC5-4ac272d7-ca5e-4a54-b338-32691fa8237b_b2f3b143-5527-46bc-a8af-dba9c8114e4c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3-(N-p-methoxy cinnamidopropyl-N,N-dimethyl ammonium)-2-hydroxypropane-1-sulphonate",500731-87-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ec44ad7-da0e-4c9d-9322-7cd00df7bd9d/documents/IUC5-4ac272d7-ca5e-4a54-b338-32691fa8237b_b2f3b143-5527-46bc-a8af-dba9c8114e4c.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "3(or 4)-methylbenzene-1,2-diamine",26966-75-6,The no observed adverse effect level (NOAEL) was 50 mg/kg body weight/day for 28 days in male and female rats. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7534e62-d63a-48fe-b057-9b88abf9bcfb/documents/IUC5-4aa9cdd0-218f-444e-bda3-bc3f923bad68_9c882fa6-4526-4702-925a-f787e440a736.html,,,,,, "3(or 4)-methylbenzene-1,2-diamine",26966-75-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7534e62-d63a-48fe-b057-9b88abf9bcfb/documents/IUC5-4aa9cdd0-218f-444e-bda3-bc3f923bad68_9c882fa6-4526-4702-925a-f787e440a736.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,, "3(or 4)-methylbenzene-1,2-diamine",26966-75-6,"For oral toxicity the LD50 was calculated as 660 mg/kg BW to rats.  By occluded dermal dressing the LD50 was calculated as 1120mg/kg BW to rabbits, or above. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7534e62-d63a-48fe-b057-9b88abf9bcfb/documents/IUC5-1277a994-8212-4e13-8a3c-7d356d726c96_9c882fa6-4526-4702-925a-f787e440a736.html,,,,,, "3(or 4)-methylbenzene-1,2-diamine",26966-75-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7534e62-d63a-48fe-b057-9b88abf9bcfb/documents/IUC5-1277a994-8212-4e13-8a3c-7d356d726c96_9c882fa6-4526-4702-925a-f787e440a736.html,,oral,LD50,660 mg/kg bw,, "3(or 4)-methylbenzene-1,2-diamine",26966-75-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7534e62-d63a-48fe-b057-9b88abf9bcfb/documents/IUC5-1277a994-8212-4e13-8a3c-7d356d726c96_9c882fa6-4526-4702-925a-f787e440a736.html,,dermal,LD50,"1,120 mg/kg bw",, "3(or 4)-methylbenzene-1,2-diamine",26966-75-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7534e62-d63a-48fe-b057-9b88abf9bcfb/documents/IUC5-1277a994-8212-4e13-8a3c-7d356d726c96_9c882fa6-4526-4702-925a-f787e440a736.html,,inhalation,discriminating conc.,"3,320 mg/m3",no adverse effect observed, 3-(trichlorosilyl)propiononitrile,1071-22-3," There are no reliable acute oral, dermal or inhalation studies available for 3-(trichlorosilyl)propiononitrile. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fde716e-50fa-4914-a14d-1be71916bf3c/documents/5aef831e-379a-4272-a774-c1fd682319a4_fee4dbb2-0906-47d3-a3e1-233f2407552d.html,,,,,, 3-(triethoxysilyl)propanethiol,14814-09-6," In a study conducted according to OECD Test Guideline 408 and in compliance with GLP (Charles River Laboratories, 2022a, reliability score 1), Wistar Han rats were administered 3-(triethoxysilyl)propanethiol (CAS No. 14814-09-6, EC No. 238-883-1) at 0, 100, 300, and 900 mg/kg bw/day via oral gavage (corn oil vehicle) for 7 days/week over 13 weeks. The systemic NOAEL for 3-(triethoxysilyl)propanethiol was <100 mg/kg bw/day, based on degenerative renal effects in females at 100 mg/kg bw/day (tubular degeneration and inflammatory cell infiltrates). For males, the systemic NOAEL was 100 mg/kg bw/day, based on renal effects starting at 300 mg/kg bw/day (above findings plus granular casts and papillary necrosis at 900 mg/kg bw/day). For local effects in the stomach (glandular and/or non-glandular), the NOAELs for females and males were 100 and 300 mg/kg bw/day, respectively. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa5065f8-e376-48e8-a179-c0b5ec257740/documents/0e8ec961-61e4-45c3-9cd5-aee902dee50e_4e57f402-8e02-4578-9670-bc0c4cf20394.html,,,,,, 3-(triethoxysilyl)propanethiol,14814-09-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa5065f8-e376-48e8-a179-c0b5ec257740/documents/0e8ec961-61e4-45c3-9cd5-aee902dee50e_4e57f402-8e02-4578-9670-bc0c4cf20394.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat 3-(triethoxysilyl)propanethiol,14814-09-6," In the key acute oral toxicity study conducted according to OECD Test Guideline 423 and in compliance with GLP (Eurofins / BSL Bioservice Scientific Laboratories, 2019, reliability score 1), the LD50 value for 3-(triethoxysilyl)propanethiol (CAS No. 14814-09-6, EC No. 238-883-1) in the Wistar rat was >2000 mg/kg bw.   For dermal toxicity, the key study for 3-(triethoxysilyl)propanethiol pre-dates GLP but was conducted according to a protocol equivalent or similar to OECD Test Guideline 402 (Carnegie-Mellon Institute of Research, 1976, reliability score 2). The LD50 was 2.52 ml/kg bw (approximately 2500 mg/kg bw) in male albino rabbit.   The acute inhalation toxicity endpoint is waived since reliable data for the acute oral and dermal endpoints are available. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa5065f8-e376-48e8-a179-c0b5ec257740/documents/5665973c-f5a5-410f-9eb4-0cc202b04d60_4e57f402-8e02-4578-9670-bc0c4cf20394.html,,,,,, 3-(triethoxysilyl)propanethiol,14814-09-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa5065f8-e376-48e8-a179-c0b5ec257740/documents/5665973c-f5a5-410f-9eb4-0cc202b04d60_4e57f402-8e02-4578-9670-bc0c4cf20394.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-(triethoxysilyl)propanethiol,14814-09-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa5065f8-e376-48e8-a179-c0b5ec257740/documents/5665973c-f5a5-410f-9eb4-0cc202b04d60_4e57f402-8e02-4578-9670-bc0c4cf20394.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, 3-(triethoxysilyl)propiononitrile,919-31-3," In a key combined repeated dose oral toxicity study with the reproduction/developmental toxicity screening test with the registered substance 3-(triethoxysilyl)propiononitrile, conducted according to OECD Test Guideline 422 and in compliance with GLP, a NOAEL for systemic effects was concluded to be 100 mg/kg bw/day (nominal) based on increased organ weights and kidney effects at the 500 mg/kg bw/day (nominal) dose (RCC Ltd, 2005)   ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64d4f02f-fa65-43db-815d-2382dd5ea8e3/documents/d181c14e-3390-44e2-b174-17519e6a3fe1_8e428843-30dc-49d0-9566-dfc791ccc80f.html,,,,,, 3-(triethoxysilyl)propiononitrile,919-31-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64d4f02f-fa65-43db-815d-2382dd5ea8e3/documents/d181c14e-3390-44e2-b174-17519e6a3fe1_8e428843-30dc-49d0-9566-dfc791ccc80f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 3-(triethoxysilyl)propiononitrile,919-31-3," In the key acute oral toxicity study, available from an IUCLID summary and claimed to be conducted using a protocol comparable to the now deleted OECD Test Guidelines 401, but predating GLP (Mellon Institute, 1956), the LD50 for 3-(triethoxysilyl)propiononitrile was 5600 mg/kg bw in male Wistar rats. In the key acute dermal toxicity study, available from an IUCLID summary and claimed to be conducted using a protocol comparable to the OECD Test Guidelines 402, but predating GLP (Mellon Institute, 1956), the LD50 for 3-(triethoxysilyl)propiononitrile was 5753 mg/kg bw in male New Zealand White rabbits. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64d4f02f-fa65-43db-815d-2382dd5ea8e3/documents/d4f95907-561b-4896-84d4-b1411aeaf371_8e428843-30dc-49d0-9566-dfc791ccc80f.html,,,,,, 3-(triethoxysilyl)propiononitrile,919-31-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64d4f02f-fa65-43db-815d-2382dd5ea8e3/documents/d4f95907-561b-4896-84d4-b1411aeaf371_8e428843-30dc-49d0-9566-dfc791ccc80f.html,,oral,LD50,"5,600 mg/kg bw",no adverse effect observed, 3-(triethoxysilyl)propiononitrile,919-31-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64d4f02f-fa65-43db-815d-2382dd5ea8e3/documents/d4f95907-561b-4896-84d4-b1411aeaf371_8e428843-30dc-49d0-9566-dfc791ccc80f.html,,dermal,LD50,"5,753 mg/kg bw",no adverse effect observed, 3-(triethoxysilyl)propyl methacrylate,21142-29-0," The key study for acute oral toxicity reports an LD50 of >5000 mg/kg bw in rat (WIL, 1995). The study was conducted according to current guideline and in compliance with GLP. The key study for acute dermal toxicity reports an LD50 of >2000 mg/kg bw in rat (WIL, 1995). The study was conducted according to current guideline and in compliance with GLP. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/499d6460-2eac-485b-b84c-946aeda10e15/documents/b97465b2-4a57-4b19-bcd6-6e5c9e881d4b_dd771972-f096-4515-816b-9af143d77975.html,,,,,, 3-(triethoxysilyl)propyl methacrylate,21142-29-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/499d6460-2eac-485b-b84c-946aeda10e15/documents/b97465b2-4a57-4b19-bcd6-6e5c9e881d4b_dd771972-f096-4515-816b-9af143d77975.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 3-(triethoxysilyl)propyl methacrylate,21142-29-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/499d6460-2eac-485b-b84c-946aeda10e15/documents/b97465b2-4a57-4b19-bcd6-6e5c9e881d4b_dd771972-f096-4515-816b-9af143d77975.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 3'-(trifluoromethyl)acetophenone,349-76-8," Acute toxicity: oral Groups of 5 male and 5 female rats were administered a single dose of the undiluted test substance by gavage at a dose level of 2000 mg/kg, followed by a 14-day post-treatment observation period. There was no mortality. Hypoactivity, piloerection and hunched posture were seen in all animals on the treatment day. All animals appeared normal by day 1 after treatment. Body weights were not affected by treatment. Necropsy examinations revealed no observable abnormalities. Therefore the LD50 in rats of both sexes is > 2000 mg/kg body weight. Acute toxicity: inhalation Groups of five male and five female Wistar rats were exposed by nose only, flow past inhalation to the aerosolized test article at a mean concentration of 6.913 mg/l for 4 hours. There were no deaths. The principal clinical signs observed wer the findings of ruffled fur, decreased spontaneous activity and uncoordinated movement/gait. All clinical signs disappeared within four days after the exposure. There were no macroscopical pathology findings. Acute toxicity: dermal Groups of 5 male and 5 female Wistar rats were administered a single dose of the test item by dermal application at a dose level of 2000 mg/kg for 24 hours under semiocclusive conditions, followed by a 14-day post-treatment observation period. There was no mortality in the study. Therefore, the acute dermal LD50 value was determined to be > 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e4c77de-de7e-4ba1-8f38-158fbf73cb80/documents/c630824a-e45d-4cc9-b690-380901e09dc5_ad78ad58-875f-4fd6-ae55-2c05ece85b82.html,,,,,, 3'-(trifluoromethyl)acetophenone,349-76-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e4c77de-de7e-4ba1-8f38-158fbf73cb80/documents/c630824a-e45d-4cc9-b690-380901e09dc5_ad78ad58-875f-4fd6-ae55-2c05ece85b82.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 3'-(trifluoromethyl)acetophenone,349-76-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e4c77de-de7e-4ba1-8f38-158fbf73cb80/documents/c630824a-e45d-4cc9-b690-380901e09dc5_ad78ad58-875f-4fd6-ae55-2c05ece85b82.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 3'-(trifluoromethyl)acetophenone,349-76-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e4c77de-de7e-4ba1-8f38-158fbf73cb80/documents/c630824a-e45d-4cc9-b690-380901e09dc5_ad78ad58-875f-4fd6-ae55-2c05ece85b82.html,,inhalation,discriminating conc.,"6,913 mg/m3",no adverse effect observed, 3-(trimethoxysilyl)propiononitrile,2526-62-7,"In the key 90-day repeat dose toxicity study, conducted according to OECD Test Guideline 408 and in compliance with GLP, the NOAEL for 3-(trimethoxysilyl)propiononitrile (CAS No. 2526-62-7; EC No. 219-764-3) was concluded to be 100 mg/kg bw/day based on tubulopathy observed at dose levels of 300 and 1000 mg/kg bw/day (Eurofins / BSL Bioservice Scientific Laboratories, 2019a, reliability score 1). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef79ceb4-133b-4ef0-bed0-c3c6c43144d8/documents/aac09e93-1605-4218-9eb5-f75cb2509e43_d268be8b-3fd0-48aa-8dc0-fae9d50308fb.html,,,,,, 3-(trimethoxysilyl)propiononitrile,2526-62-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef79ceb4-133b-4ef0-bed0-c3c6c43144d8/documents/aac09e93-1605-4218-9eb5-f75cb2509e43_d268be8b-3fd0-48aa-8dc0-fae9d50308fb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 3-(trimethoxysilyl)propiononitrile,2526-62-7,"There are two key studies available to describe the reliable acute toxicity data for the registered substance 3-(trimethoxysilyl)propiononitrile (CAS No. 2526-62-7; EC No. 219-764-3).   In the key acute oral gavage study performed in a manner similar to the now deleted OECD Test Guideline 401 but pre-GLP (Bushy Run Research Center, 1982, reliability score 2), the oral LD50 for 3-(trimethoxysilyl)propiononitrile in rats was 9.85 ml/kg bw for males and 11.3 ml/kg bw for females (9555 mg/kg bw and 10961 mg/kg bw, respectively, based on a relative density of 0.97 g/cm3).   In the key acute dermal gavage study conducted in a manner similar to OECD Test Guideline 402 but pre-GLP ( Bushy Run Research Center, 1982, reliability score 2), the dermal LD50 for 3-(trimethoxysilyl)propiononitrile in rabbits was greater than 16 ml/kg bw (15520 mg/kg bw, respectively, based on a relative density of 0.97 g/cm³).   Reliable inhalation data are not needed since such data are available for the oral and dermal routes. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef79ceb4-133b-4ef0-bed0-c3c6c43144d8/documents/3fd0bc60-35bd-4191-8424-58ba92ad740c_d268be8b-3fd0-48aa-8dc0-fae9d50308fb.html,,,,,, 3-(trimethoxysilyl)propiononitrile,2526-62-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef79ceb4-133b-4ef0-bed0-c3c6c43144d8/documents/3fd0bc60-35bd-4191-8424-58ba92ad740c_d268be8b-3fd0-48aa-8dc0-fae9d50308fb.html,,oral,LD50,"9,555 mg/kg bw",no adverse effect observed, 3-(trimethoxysilyl)propiononitrile,2526-62-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef79ceb4-133b-4ef0-bed0-c3c6c43144d8/documents/3fd0bc60-35bd-4191-8424-58ba92ad740c_d268be8b-3fd0-48aa-8dc0-fae9d50308fb.html,,dermal,LD50,"> 15,520 mg/kg bw",no adverse effect observed, 3-(trimethoxysilyl)propyl isocyanate,15396-00-6," There are no repeated dose toxicity data for the registered substance, 3-(trimethoxysilyl)propyl isocyanate, therefore data for the immediate disintegration/hydrolysis product have been used. The key repeated dose toxicity study is a 90-day oral (gavage) study with the immediate disintegration/hydrolysis product, 3-(trimethoxysilyl)propylamine, conducted in male and female rats, according to OECD Test Guideline 408 and in compliance with GLP. The study concluded a LOAEL of <100 mg/kg bw/day. This LOAEL related to local effects. The NOAEL for systemic effects was concluded to be 100 mg/kg bw/day, based on changes in oestrous cyclicity. These effects may be related to low and/or reduced body weight resulting from and therefore secondary to local effects. This will be clarified in the EOGRT test on the immediate disintegration/hydrolysis product, 3-(trimethoxysilyl)propylamine. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ebbac30-d84c-4de2-81c5-50ef4908951f/documents/1726c239-b5f1-4cfd-94eb-23fbff7c394b_ae5c6678-30c3-42c0-b440-777917031146.html,,,,,, 3-(trimethoxysilyl)propyl isocyanate,15396-00-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ebbac30-d84c-4de2-81c5-50ef4908951f/documents/1726c239-b5f1-4cfd-94eb-23fbff7c394b_ae5c6678-30c3-42c0-b440-777917031146.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 3-(trimethoxysilyl)propyl isocyanate,15396-00-6," In the key acute oral toxicity study, conducted to the now deleted OECD Test Guideline 401 and in compliance with GLP (Bushy Run Research Center, 1995), the LD50 values in male and female rats were >500 and 878 mg/kg bw, respectively for 3-(trimethoxysilyl)propyl isocyanate. There were no clinical signs of toxicity in males given 500 mg/kg bw test substance in corn oil. Signs in females included hypoactivity, diarrhoea, darkened eyes, pale extremities, slow breathing, abdominal breathing, piloerection, lacrimation, hind limb cyanosis (in 1), prostration (in 1), an unkempt appearance (in 1), a brown stain on the perianal fur and a red crust on the perinasal fur. Most affected survivors recovered within 2 hours to 2 days. Two females recovered at 4 or 7 days.  In the key acute dermal toxicity study, conducted according to a protocol similar to OECD Test Guideline 402 and in compliance with GLP (Bushy Run Research Center, 1995), the LD50 values in male and female rabbits were 1190 and >2000 mg/kg bw, respectively for 3-(trimethoxysilyl)propyl isocyanate. There were signs of skin irritation. Signs of toxicity included hypoactivity, prostration, slow breathing, shallow breathing, an abnormal gait (in 2 ), rapid breathing, diarrhoea (in 1), front limb splay and marked hindlimb splay (in 1 male that died), marked weakness of right hind limb (in 1 male that died), weakened front limbs (in 1 male that died), pallor (in 2), an abnormal tilting of the head (in l), emaciation, iritis (in 1), dehydrated appearance (in 1), discharge or crust (mostly brown) on the perianal fur, and wetness of the perioral and perinasal fur. Most affected survivors recovered at 1 to 4 days. Two rabbits exhibited signs at 13 and/or 14 days. In the acute vapour inhalation study, conducted according to OECD Test Guideline 403 and in compliance with GLP (WIL Research Laboratories, 2004), the LC50 for a 4-hour exposure to 3-(trimethoxysilyl)propyl isocyanate was 15 ppm (125.95 mg/m3) in rats. Clinical observations and necropsy findings indicated local effects on the respiratory tract. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ebbac30-d84c-4de2-81c5-50ef4908951f/documents/01546d13-fff9-46de-8424-54f2528cfb4a_ae5c6678-30c3-42c0-b440-777917031146.html,,,,,, 3-(trimethoxysilyl)propyl isocyanate,15396-00-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ebbac30-d84c-4de2-81c5-50ef4908951f/documents/01546d13-fff9-46de-8424-54f2528cfb4a_ae5c6678-30c3-42c0-b440-777917031146.html,,oral,LD50,878 mg/kg bw,adverse effect observed, 3-(trimethoxysilyl)propyl isocyanate,15396-00-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ebbac30-d84c-4de2-81c5-50ef4908951f/documents/01546d13-fff9-46de-8424-54f2528cfb4a_ae5c6678-30c3-42c0-b440-777917031146.html,,dermal,LD50,"1,190 mg/kg bw",adverse effect observed, 3-(trimethoxysilyl)propyl isocyanate,15396-00-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ebbac30-d84c-4de2-81c5-50ef4908951f/documents/01546d13-fff9-46de-8424-54f2528cfb4a_ae5c6678-30c3-42c0-b440-777917031146.html,,inhalation,LC50,125.95 mg/m3,adverse effect observed, 3-(trimethoxysilyl)propylamine,13822-56-5,"The key repeat dose toxicity study for 3-(trimethoxysilyl)propylamine (CAS RN 13822-56-5; EC No 237-511-5) (Charles River Laboratories, 2018a, reliability 1) is the only available study for this endpoint. The key repeated dose toxicity study was a 90-day oral (gavage) study conducted in male and female rats, according to OECD Test Guideline 408 and in compliance with GLP. The study concluded a LOAEL of <100 mg/kg bw/day for local effects. The NOAEL for systemic toxicity is ≥1000 mg/kg bw/day.     ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5766b2d9-0a60-4e64-8985-58639b49d5af/documents/02a7a703-c6d4-4d7e-a6a6-88a1661744d5_085d3138-d12d-413f-aa7c-23ea7b60fdfa.html,,,,,, 3-(trimethoxysilyl)propylamine,13822-56-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5766b2d9-0a60-4e64-8985-58639b49d5af/documents/02a7a703-c6d4-4d7e-a6a6-88a1661744d5_085d3138-d12d-413f-aa7c-23ea7b60fdfa.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat 3-(trimethoxysilyl)propylamine,13822-56-5,"The key acute oral study is available for the 3-(trimethoxysilyl)propylamine (CAS RN 13822-56-5; EC No. 237-511-5). The study was conducted similar to OECD Test Guideline 401 but was not compliant with GLP and identified LD50 value of 3010 mg/kg bw (BRRC, 1980, reliability 2) .   The key dermal study available for 3-(trimethoxysilyl)propylamine (CAS RN 13822-56-5; EC No. 237-511-5) was carried out according to a protocol that was similar to OECD Test Guideline 402 but was not compliant with GLP. The identified LD50 value was 11460 mg/kg bw (BRRC, 1980, reliability 2).       ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5766b2d9-0a60-4e64-8985-58639b49d5af/documents/5acae073-d40c-4828-84c3-4a8c6a2949ed_085d3138-d12d-413f-aa7c-23ea7b60fdfa.html,,,,,, 3-(trimethoxysilyl)propylamine,13822-56-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5766b2d9-0a60-4e64-8985-58639b49d5af/documents/5acae073-d40c-4828-84c3-4a8c6a2949ed_085d3138-d12d-413f-aa7c-23ea7b60fdfa.html,,oral,LD50,"3,010 mg/kg bw",no adverse effect observed, 3-(trimethoxysilyl)propylamine,13822-56-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5766b2d9-0a60-4e64-8985-58639b49d5af/documents/5acae073-d40c-4828-84c3-4a8c6a2949ed_085d3138-d12d-413f-aa7c-23ea7b60fdfa.html,,dermal,LD50,"11,460 mg/kg bw",no adverse effect observed, "3,10-diamino-6,13-dichloro-2-((6-(((4-(1,1-dimethylethyl)phenyl)sulfonyl)amino)-2-naphthalenyl)sulfonyl)-4,11-triphenodioxazinedisulfonic acid, lithium potassium sodium salt",371921-63-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimish code 1 (OECD 407 & GLP) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef6c42fc-2f8c-442e-a21a-0453ec1231fc/documents/8a9ce8bd-2f7a-4a36-8b68-3042d8c9c70d_1d8ce025-1b5e-4bbb-8de0-0d125c39e213.html,,,,,, "3,10-diamino-6,13-dichloro-2-((6-(((4-(1,1-dimethylethyl)phenyl)sulfonyl)amino)-2-naphthalenyl)sulfonyl)-4,11-triphenodioxazinedisulfonic acid, lithium potassium sodium salt",371921-63-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef6c42fc-2f8c-442e-a21a-0453ec1231fc/documents/8a9ce8bd-2f7a-4a36-8b68-3042d8c9c70d_1d8ce025-1b5e-4bbb-8de0-0d125c39e213.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,10-diamino-6,13-dichloro-2-((6-(((4-(1,1-dimethylethyl)phenyl)sulfonyl)amino)-2-naphthalenyl)sulfonyl)-4,11-triphenodioxazinedisulfonic acid, lithium potassium sodium salt",371921-63-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch code 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch code 1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef6c42fc-2f8c-442e-a21a-0453ec1231fc/documents/f0dacd73-1bc4-4d87-889c-c8c025528940_1d8ce025-1b5e-4bbb-8de0-0d125c39e213.html,,,,,, "3,10-diamino-6,13-dichloro-2-((6-(((4-(1,1-dimethylethyl)phenyl)sulfonyl)amino)-2-naphthalenyl)sulfonyl)-4,11-triphenodioxazinedisulfonic acid, lithium potassium sodium salt",371921-63-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef6c42fc-2f8c-442e-a21a-0453ec1231fc/documents/f0dacd73-1bc4-4d87-889c-c8c025528940_1d8ce025-1b5e-4bbb-8de0-0d125c39e213.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,10-diamino-6,13-dichloro-2-((6-(((4-(1,1-dimethylethyl)phenyl)sulfonyl)amino)-2-naphthalenyl)sulfonyl)-4,11-triphenodioxazinedisulfonic acid, lithium potassium sodium salt",371921-63-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef6c42fc-2f8c-442e-a21a-0453ec1231fc/documents/f0dacd73-1bc4-4d87-889c-c8c025528940_1d8ce025-1b5e-4bbb-8de0-0d125c39e213.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine",2469-55-8," According to Section 8.5 of Annex VII, an acute oral toxicity study with the registered substance is not required as the substance is classified as corrosive to the skin. In the key acute dermal toxicity study conducted according to a protocol similar to OECD 402 and in compliance with GLP, the LD50 value reported for 3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine was ≥2000 mg/kg bw (IRDC, 1985). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61abbb0d-e537-4c04-b4b9-e5b4f2908529/documents/2caee25f-d8c7-4621-80f8-247550b5743f_ee0ad31e-43ae-4eb6-ab45-b7ca70f9e19b.html,,,,,, "3,3'-(1,1,3,3-tetramethyldisiloxane-1,3-diyl)bispropylamine",2469-55-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61abbb0d-e537-4c04-b4b9-e5b4f2908529/documents/2caee25f-d8c7-4621-80f8-247550b5743f_ee0ad31e-43ae-4eb6-ab45-b7ca70f9e19b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,3'-(1,4-phenylenediimino)bis[4,5,6,7-tetrachloro-1H-isoindol-1-one]",5590-18-1," Repeated dose toxicity: via oral route: Study 1: In a study performed according to OECD 407 (adopted in 2008), the study-derived NOAEL for the registered substance was 1000 mg/kg bw/day. This effect level was based on the absence of any toxic effect when the substance was tested up to 1000 mg/kg bw/day. Repeated dose toxicity via inhalation route: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. The test chemical has a low vapour pressure value; it is reported to be 6.638046e-20 mmHg at 25°C. The particle size distribution of the test substance is in the range of 150-10 micron, which is larger than the inhalable particulate size. Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely. Therefore, the repeated dose toxicity study via inhalation route is considered for waiver. Repeated dose toxicity via dermal route: The acute toxicity value for the test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Given the use of the chemical, repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that the test chemical does not exhibit toxicity by dermal route after repeated exposure. In addition, there is no data available that suggests that test chemical exhibit repeated dose toxicity by the dermal route. Hence this endpoint was considered for waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4c2b5e7-022e-4f5a-9452-d5e8f8f49a2a/documents/a13a21f7-9c80-46ef-b78b-44c73706e705_6a9cc80d-5d39-44a0-ba27-ade942d0b9d9.html,,,,,, "3,3'-(1,4-phenylenediimino)bis[4,5,6,7-tetrachloro-1H-isoindol-1-one]",5590-18-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4c2b5e7-022e-4f5a-9452-d5e8f8f49a2a/documents/a13a21f7-9c80-46ef-b78b-44c73706e705_6a9cc80d-5d39-44a0-ba27-ade942d0b9d9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,3'-(1,4-phenylenediimino)bis[4,5,6,7-tetrachloro-1H-isoindol-1-one]",5590-18-1," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 8.85E-018 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4c2b5e7-022e-4f5a-9452-d5e8f8f49a2a/documents/15e0d414-7c3f-4c63-a453-b69b733d3cd1_6a9cc80d-5d39-44a0-ba27-ade942d0b9d9.html,,,,,, "3,3'-(1,4-phenylenediimino)bis[4,5,6,7-tetrachloro-1H-isoindol-1-one]",5590-18-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4c2b5e7-022e-4f5a-9452-d5e8f8f49a2a/documents/15e0d414-7c3f-4c63-a453-b69b733d3cd1_6a9cc80d-5d39-44a0-ba27-ade942d0b9d9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,3'-(1,4-phenylenediimino)bis[4,5,6,7-tetrachloro-1H-isoindol-1-one]",5590-18-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4c2b5e7-022e-4f5a-9452-d5e8f8f49a2a/documents/15e0d414-7c3f-4c63-a453-b69b733d3cd1_6a9cc80d-5d39-44a0-ba27-ade942d0b9d9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,3,3-trifluoro-2-(trifluoromethyl)propene",382-10-5," HFIB is classified as Acute Tox. 3, H331 - Toxic if inhaled. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7acdc1e3-dc66-42de-b7f2-86d6487e8689/documents/3cefd400-8e92-4e96-909e-a796cda55a43_264f17e0-028f-4c7e-81ad-2b587013ef4b.html,,,,,, "3,3,3-trifluoro-2-(trifluoromethyl)propene",382-10-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7acdc1e3-dc66-42de-b7f2-86d6487e8689/documents/3cefd400-8e92-4e96-909e-a796cda55a43_264f17e0-028f-4c7e-81ad-2b587013ef4b.html,,inhalation,LC50,"1,425 ",adverse effect observed, "3,3,4,4,5,5,6,6,6-nonafluorohexene",19430-93-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e817a741-c3b7-4675-a2fc-8fe904f3d7cc/documents/IUC5-d17f7d6d-2150-456e-8568-7f63229b6913_f5d83909-0b84-481b-9c13-4746bc0a1bd7.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"20,123 mg/m3",,rat "3,3,4,4,5,5,6,6,6-nonafluorohexene",19430-93-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e817a741-c3b7-4675-a2fc-8fe904f3d7cc/documents/IUC5-5c37f583-2df7-40c9-b314-30cd1545babd_f5d83909-0b84-481b-9c13-4746bc0a1bd7.html,,oral,LD50,"25,000 mg/kg bw",no adverse effect observed, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooct-1-ene",25291-17-2," Short-term oral toxicity (OECD 407, rats): LOAEL = 25 mg/kg bw/day; NOAEL = 5 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0656072-f4d9-4029-9ede-8ac5b14a8f75/documents/cbe64ad3-cb2f-42be-9ed4-cdb9c759d823_4cb81e60-1f64-4354-8003-7f3628e4619a.html,,,,,, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooct-1-ene",25291-17-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0656072-f4d9-4029-9ede-8ac5b14a8f75/documents/cbe64ad3-cb2f-42be-9ed4-cdb9c759d823_4cb81e60-1f64-4354-8003-7f3628e4619a.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooct-1-ene",25291-17-2," Acute oral toxicity (OECD 420, GLP): LD50 (rat, female) > 2000 mg/kg bw Acute dermal toxicity (OECD 402, GLP): LD50 (rat, female/male) > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0656072-f4d9-4029-9ede-8ac5b14a8f75/documents/a29ef90f-c47a-4967-be02-0fdee5240775_4cb81e60-1f64-4354-8003-7f3628e4619a.html,,,,,, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonic acid",27619-97-2," Key information: Repeated dose toxicity study (OECD 422, Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test): A systemic NOAEL was established at 15.0 mg/kg bw and a LOEC 45 mg/kg bw/day; Read across from analogue source substance; Supporting information: Short-term repeated dose toxicity: oral: rat NOAEL was determined to be 30 ppm. The NOAEL was based on the increases in mean absolute and relative liver weight observed in the 300 and 3000 ppm dose groups and the decreases in mean body weights and body weight gains observed in the 3000 ppm dose group. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/618aa105-1c47-4bc7-9633-bb54ae800bcd/documents/f08f2193-dabb-40e0-815c-6fdbc27769a3_0d1124ae-0efe-4499-a89e-7ed10d6c4b2c.html,,,,,, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonic acid",27619-97-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/618aa105-1c47-4bc7-9633-bb54ae800bcd/documents/f08f2193-dabb-40e0-815c-6fdbc27769a3_0d1124ae-0efe-4499-a89e-7ed10d6c4b2c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonic acid",27619-97-2," Read across from source substance 1-Octanesulfonic acid, 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-, potassium salt: Acute oral toxicity (OECD 420, fixed dose method): LD50 between 300 and 2000 mg/kg bw; Based on these results, the test substance is considered to be acutely harmful (category 4). Read across from source substance 1-Octanesulfonic acid, 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluoro-, potassium salt: Acute dermal (OECD 402, acute dermal toxicity): LD50 > 2000 mg/kg bw; ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/618aa105-1c47-4bc7-9633-bb54ae800bcd/documents/eab260db-02ee-474f-8fae-c313e0a2255a_0d1124ae-0efe-4499-a89e-7ed10d6c4b2c.html,,,,,, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl acrylate",17527-29-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): No acute effects were observed in this read-across study on 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol and the NOAEC was derived based on systemic effects only. The 100 ppm high dose group showing no acute effects can be estimated by conversion, considering molecular weight differences as 1711 mg/m3. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Systemic effects were observed in this read-across study on 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctan-1-ol at the high-dose group, limited to increased serum ALT and bilirubin levels (females) and increased liver weights in both male and females exposed to 100 ppm. Therefore, the NOAEC was set to 25 ppm (estimated by conversion, considering molecular weight differences as 428 mg/m3) in this surrogate study for the target substance 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl acrylate. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/84f4ff1f-acaf-4700-bb90-4b244426a917/documents/IUC5-3fe4b621-4ce6-4064-9aa9-3b1cc606f84c_795f1b4e-7c12-45e4-8fc7-8b556cf02eac.html,,,,,, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl acrylate",17527-29-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/84f4ff1f-acaf-4700-bb90-4b244426a917/documents/IUC5-3fe4b621-4ce6-4064-9aa9-3b1cc606f84c_795f1b4e-7c12-45e4-8fc7-8b556cf02eac.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,428 mg/m3,,rat "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl acrylate",17527-29-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/84f4ff1f-acaf-4700-bb90-4b244426a917/documents/IUC5-3fe4b621-4ce6-4064-9aa9-3b1cc606f84c_795f1b4e-7c12-45e4-8fc7-8b556cf02eac.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5.76 mg/kg bw/day,,mouse "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl acrylate",17527-29-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/84f4ff1f-acaf-4700-bb90-4b244426a917/documents/IUC5-3fe4b621-4ce6-4064-9aa9-3b1cc606f84c_795f1b4e-7c12-45e4-8fc7-8b556cf02eac.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,711 mg/m3",no adverse effect observed,rat "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl acrylate",17527-29-6," LD50 (oral, rabbit): >5000 mg/kg bw LD50 (inhalation, rabbit): Not determinable LD50 (dermal): not tested ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84f4ff1f-acaf-4700-bb90-4b244426a917/documents/IUC5-1eef993c-9ce7-4fcf-922b-1727951ade27_795f1b4e-7c12-45e4-8fc7-8b556cf02eac.html,,,,,, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl acrylate",17527-29-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84f4ff1f-acaf-4700-bb90-4b244426a917/documents/IUC5-1eef993c-9ce7-4fcf-922b-1727951ade27_795f1b4e-7c12-45e4-8fc7-8b556cf02eac.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate",2144-53-8,"The NOAEL in a 90-day oral study with 6:2 FTOH is 5 mg/kg/day, based on changes observed in haematology and clinical chemistry parameters, urinalysis parameters (females only), urine fluoride, and histopathological effects in the liver, which corrected for molecular weight differences between the test and read across substances, would yield an equivalent test substance NOAEL of 5.95 mg/kg/day. The LOAEC in a 28-day inhalation study with 6:2 FTOH is 100 ppm (1490 mg/m3), based on low incidence of combined increases in serum ALT and bilirubin levels, and increased liver weights in females exposed to 100 ppm, , which corrected for molecular weight differences between the test and read across substances, would yield an equivalent test substance NOAEC of 1773 mg/m3. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8a5c20c-5376-4663-a9f4-82d04511372f/documents/IUC5-e00eeaa1-769b-45f2-8c05-ac41cdf69488_57685a00-8cd4-451f-84da-e6c66d33e081.html,,,,,, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate",2144-53-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8a5c20c-5376-4663-a9f4-82d04511372f/documents/IUC5-e00eeaa1-769b-45f2-8c05-ac41cdf69488_57685a00-8cd4-451f-84da-e6c66d33e081.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5.95 mg/kg bw/day,,mouse "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate",2144-53-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8a5c20c-5376-4663-a9f4-82d04511372f/documents/IUC5-e00eeaa1-769b-45f2-8c05-ac41cdf69488_57685a00-8cd4-451f-84da-e6c66d33e081.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,"1,773 mg/m3",,rat "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate",2144-53-8,Oral: OECD425; rat LD50 >5000 mg/kg. Reliability = 1Dermal: OECD 402; rat LD50 >5000 mg/kg. Reliability = 1Inhalation: OECD 403; rat 4-hr LC50 >5.2 mg/L (equivalent to >6.188 mg/L test substance corrected for molecular weight difference between test and read across substance). Reliability =2 ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8a5c20c-5376-4663-a9f4-82d04511372f/documents/IUC5-6d189af2-f635-40e8-aa4d-31bfd52801df_57685a00-8cd4-451f-84da-e6c66d33e081.html,,,,,, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate",2144-53-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8a5c20c-5376-4663-a9f4-82d04511372f/documents/IUC5-6d189af2-f635-40e8-aa4d-31bfd52801df_57685a00-8cd4-451f-84da-e6c66d33e081.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate",2144-53-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8a5c20c-5376-4663-a9f4-82d04511372f/documents/IUC5-6d189af2-f635-40e8-aa4d-31bfd52801df_57685a00-8cd4-451f-84da-e6c66d33e081.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl methacrylate",2144-53-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8a5c20c-5376-4663-a9f4-82d04511372f/documents/IUC5-6d189af2-f635-40e8-aa4d-31bfd52801df_57685a00-8cd4-451f-84da-e6c66d33e081.html,,inhalation,LC50,"6,188 mg/m3",no adverse effect observed, "3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene",1800-91-5," Results of the OECD 422 screening study (GLP) conducted in Wistar rats administered 1,6-divinylperfluorohexane by the oral route (gavage) at up to 1000 mg/kg/day - NOAEL: 250 mg/kg/day, based on adverse findings in the liver at 1000 mg/kg/day The main effects at the highest dose were hepatocellular vacuolation centrilobular macro and micro vesicular, up to a marked degree in males. This correlated with the significant increase in liver weight (both absolute and relative to body weight) and the macroscopic enlargement of the liver. These effects are consistent with an adaptative response. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5999f9e2-69e8-4913-bc8f-c7ef33569b46/documents/e8ce578d-5805-4c77-a46f-a46f311e5dd6_03e04990-8a17-4d1f-aade-48e024b6c0da.html,,,,,, "3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene",1800-91-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5999f9e2-69e8-4913-bc8f-c7ef33569b46/documents/e8ce578d-5805-4c77-a46f-a46f311e5dd6_03e04990-8a17-4d1f-aade-48e024b6c0da.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene",1800-91-5,"Oral: LD50 > 2,000 mg/kg for rat (limit test)Inhalation: LC50 > 1761 ppm for rat (correspond to 25.5 mg/l; maximum stable vapour concentration achievable)Dermal: LD50: > 2,000 mg/kg for rat (limit test) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5999f9e2-69e8-4913-bc8f-c7ef33569b46/documents/IUC5-22cb49f4-e476-4eb3-b527-dd608fdf4473_03e04990-8a17-4d1f-aade-48e024b6c0da.html,,,,,, "3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene",1800-91-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5999f9e2-69e8-4913-bc8f-c7ef33569b46/documents/IUC5-22cb49f4-e476-4eb3-b527-dd608fdf4473_03e04990-8a17-4d1f-aade-48e024b6c0da.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene",1800-91-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5999f9e2-69e8-4913-bc8f-c7ef33569b46/documents/IUC5-22cb49f4-e476-4eb3-b527-dd608fdf4473_03e04990-8a17-4d1f-aade-48e024b6c0da.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "3,3,4,4,5,5,6,6,7,7,8,8-dodecafluorodeca-1,9-diene",1800-91-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5999f9e2-69e8-4913-bc8f-c7ef33569b46/documents/IUC5-22cb49f4-e476-4eb3-b527-dd608fdf4473_03e04990-8a17-4d1f-aade-48e024b6c0da.html,,inhalation,LC50,"> 25,500 mg/m3",no adverse effect observed, "3,3,5-trimethylcyclohexan-1-one",873-94-9," 3,3,5-trimethylcyclohexan-1-one is manufactured and used under strictly controlled conditions (SCC) according to Article 18.4 (Annex XI.3.2. (b); or  b). The lack of significant exposure is verified by workplace measurements. Due to the fact that no long-term toxicity data are available a reliable DNEL as indicated in Annex XI.3.2.(a)(ii) cannot be derived. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3394de78-ffe1-4c2f-8d38-a38976da6999/documents/IUC5-23d3ab54-83a3-416d-b940-620e0657b9fe_5ecc6225-a3ce-4ef6-b876-d265630638db.html,,,,,, "3,3,5-trimethylcyclohexan-1-one",873-94-9," Acute oral toxicity was assessed in a limit test according to OECD 401 (Hüls, 1995). The LD 50 was above 2000 mg/kg bw. Acute toxicity by inhalation was assessed in an acute inhalation toxicity study similar to OECD 403 (Hazleton, 1965). Based on this test, a LC 50 value of 14.2 mg/l was concluded. The dermal route was assessed in a limit test according to OECD 402 (Hüls, 1996). The LD50 was determined to be above 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3394de78-ffe1-4c2f-8d38-a38976da6999/documents/IUC5-4033d17b-de9d-4e5f-9161-a52f0b15e608_5ecc6225-a3ce-4ef6-b876-d265630638db.html,,,,,, "3,3,5-trimethylcyclohexan-1-one",873-94-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3394de78-ffe1-4c2f-8d38-a38976da6999/documents/IUC5-4033d17b-de9d-4e5f-9161-a52f0b15e608_5ecc6225-a3ce-4ef6-b876-d265630638db.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,3,5-trimethylcyclohexan-1-one",873-94-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3394de78-ffe1-4c2f-8d38-a38976da6999/documents/IUC5-4033d17b-de9d-4e5f-9161-a52f0b15e608_5ecc6225-a3ce-4ef6-b876-d265630638db.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,3,5-trimethylcyclohexan-1-one",873-94-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3394de78-ffe1-4c2f-8d38-a38976da6999/documents/IUC5-4033d17b-de9d-4e5f-9161-a52f0b15e608_5ecc6225-a3ce-4ef6-b876-d265630638db.html,,inhalation,LC50,"14,200 mg/m3",no adverse effect observed, "3,3,5-trimethylcyclohexyl methacrylate",7779-31-9," No data on repeated toxicity is available on 3,3,5 -trimethylcyclohexyl methacrylate. However a reliable study is available on an analogue substance : In the 28 -day repeated toxicity study (OECD 422), 3,3,5 -trimethylcyclohexyl acrylate was administered daily by oral gavage to male and female Sprague Dawley rats, for 4 weeks for males and at least 7 weeks for females, at the doses of 100, 300 and 1000 mg/kg bw/day. No adverse effect was observed in this study at any doses. Therefore, based on the experimental conditions of this study: the NOAEL for parental toxicity was 1000 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac3c3a37-4a49-4558-91f5-05629155c6e6/documents/7aa420ce-ef25-44b4-b900-27b2faf85b77_30a0fdad-2257-48cf-8507-fa53088d253b.html,,,,,, "3,3,5-trimethylcyclohexyl methacrylate",7779-31-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac3c3a37-4a49-4558-91f5-05629155c6e6/documents/7aa420ce-ef25-44b4-b900-27b2faf85b77_30a0fdad-2257-48cf-8507-fa53088d253b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,3,5-trimethylcyclohexyl methacrylate",7779-31-9,"To evaluate the acute toxicity potential of 3,3,5 -trimethylcyclohexyl-methacrylate, two studies are available. An acute study by oral route showed no mortality at the dose of 5000 mg/kg/day in rats. An acute study by dermal route on an analogue showed no mortality at the dose of 2000 mg/kg/day in rats. No data is available by inhalation. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is considered as valid with a klimisch score of 1. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study is considered as valid with a klimisch score of 1. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac3c3a37-4a49-4558-91f5-05629155c6e6/documents/b21bc59e-11c7-4e27-b67d-866e4594f10c_30a0fdad-2257-48cf-8507-fa53088d253b.html,,,,,, "3,3,5-trimethylcyclohexyl methacrylate",7779-31-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac3c3a37-4a49-4558-91f5-05629155c6e6/documents/b21bc59e-11c7-4e27-b67d-866e4594f10c_30a0fdad-2257-48cf-8507-fa53088d253b.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "3,3,5-trimethylcyclohexyl methacrylate",7779-31-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac3c3a37-4a49-4558-91f5-05629155c6e6/documents/b21bc59e-11c7-4e27-b67d-866e4594f10c_30a0fdad-2257-48cf-8507-fa53088d253b.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3,3,6,6-tetramethoxy-2,7-dioxa-3,6-disilaoctane",18406-41-2," Several repeated dose inhalation studies with the test material as a vapor are available and were evaluated in a weight of evidence approach: Crofoot et al., 1993: An acute and 14 -day repeated dose inhalation study was initiated to assess the inhalation toxicity and to determine the NOAEL of DOW CORNING® X1-6154A Additive in rats. The study consisted of both an acute and repeated dose phase. Eight groups of five rats/sex were exposed acutely for six hours to target concentrations of 0, 0.5, 1.0 and 2.0 ppm of the test material. Four groups, one from each concentration level, were sacrificed immediately following exposure. The remaining groups were scheduled to be sacrificed following a 14 -day recovery period. The repeated dose phase was scheduled to expose four grups of rats to the same target concentrations as the acute phase for six hours per day for two weeks. The actual exposure concentrations of DOW CORNING® X1-6154A for the acute and repeated dose phases were 0.4, 0.9 and 1.9 ppm. In the repeated dose phase, two males and two females in the 2.0 ppm group died after the second exposure to DOW CORNING® X1 -6154A Additive. All surviving rats in the 1.0 and 2.0 ppm groups were sacrificed in a moribund state before the third exposure. Rats in the 0.5 ppm group were sacrificed in a moribund state after the fourth exposure along with the corresponding control animals. Test article-related gross findings in the repeated dose phase included corneal opacity and ulceration, nasal obstruction and failure of the lungs to collapse. These gross findings were correlated with histopathologic changes observed in these tissues. Microscopic examination of tissues and organs indicated that various levels of the respiratory tract had epithelial necrosis with associated fibrinopurulent exudate, olfactory epithelium was less severely involved and squamous epithelium was spared. Chemical related toxicity was also observed in the eye and lung. A NOAEC could not be determined. Siddiqui et al., 1997: A 14 -day repeated dose inhalation toxicity study was conducted to investigate the inhalation toxicity of DOW CORNING® X1 -6145A Additive, chemically described as hexamethyldisilylethane (CAS no 18406 -41 -2), in rats. A previously conducted inhalation toxicity study with DOW CORNING® X1 -6145A Additive was terminated, because the target exposure concentrations were too high and caused morbitiy in rats (Crofoot et al., 1993). The purpose of the present study was to assess the repeated dose inhalation toxicity of DOW CORNING® X1 -6145A Additive and to determine the NOAEL in rats. Four groups of ten male and ten female Fischer 344 rats were exposed to target concentrations of 0, 50, 100 and 200 ppb of the substance for six hours a day, for ten exposures over 14 days (excluding weekends). Animals were observed for treatment-related signs of toxicity, growth, and mortality. At termination of the study, rats were sacrificed and examined fro changes in organ weights, gross pathology, and histopathology. No mortality was observed in the study. Very slight to moderate rales were observed in several animals exposed to 100 and 200 ppb. No apparent treatment-related clinical signs were observed in animals exposed to 50 ppb. Statistically significant decreases in body weights were observed in males exposed to 200 ppb on day 8, 15, and at sacrifice. Female body weights were decreased in animals exposed to 200 ppb onl day 8 only. Statistically significant increases in liver/body weight ratios were observed in males exposed to 100 and 200 ppb of the test material. Statistically significant increases in kidney/body weight ratios were observed in males exposed to 200 ppb of the test material. A statistically significant increase in liver/body weight ratio and in the adrenal/body weight ratio was observed in females exposed to 200 ppb of the test material. There were no other statistically significant differences in organ weights between test and control animals. There were no apparent test article-related gross pathological changes in exposed animals. Test article-related changes were observed microscopically in the respiratory tract of all animals exposed to the test material. The nares, nasal cavity, and pharynx were the most common sites of test article-related changes with the larynx and trachea only infrequently affected. Squamous metaplasia and acute inflammation of the nasal cavity were the most common findings in the 200 ppb group and also occurred, with somewhat reduced incidence and severity, in many rats from the 50 and 100 ppb groups. An increased activity of mucus goble cells of the respiratory epithelium, characterized by incresaed height and prominence of goblet cells with formation of microcysts, was the most common finding in all sections of the nasal cavity from the 50 and 100 ppb groups. All lesions in the lung and other organs examined microscopically were considered agonal and spontaneous and unrelated to test article exposure. Based on these results, a NOAEC was not established for the test material in Fischer 344 rats under the conditions of this study. Kolesar et al., 1992: A 14 -day vapor inhalation toxicity study was initiated in rats to assess the inhalation toxicity of DOW CORNING® X1-6154A Additive. Three groups of five male and five female Sprague-Dawley rats were to be exposed to target concentrations of 0, 3 and 10 ppm of DOW CORNING® X1 -6154A Additive for six hours/day, five days a week, for two weeks. One male rat in the 10 ppm group died during the second exposure period. After the second exposure, all surviving test animals were clinically moribund in severe respiratory distress and the study was terminated. The actual overall mean exposure concentration of DOW CORNING® X1 -6154A Additive for the test groups were 2.0 and 13.0 ppm. Clinical signs observed in the two-day period included dyspnea, lethargy and nasal and/or oral discharges. Gross pathological examination revealed nasal passage occlusion and distension of the digestive tracts of all exposed animals. Histopathology of the respiratory tract revealed severe and extensive damage to the lining of the nasal cavity, trachea and bronchi in animals exposed to the test-article. Lesions, consisting of necrosis and desquamation of respiratory tract epithelium and fibrinopurulent inflammatory exudate, were generally most severe in the most anterior level of the nasal cavity. Similar necrotizing lesions were present throughout the respiratory tree down to the level of the bronchi in most rats. Lung parenchyma was not involved with the test article-related lesions. A NOAEC could not be determined. Discussion: A NOAEC could not be determined in any of the available repeated dose studies. The test material exhibited severe toxicity in all of the studies, including mortality at concentrations as low as 0.5 ppm. The study by Siddiqui et al. (1997) was the only one in which mortality did not occur. None of the concentrations tested in that study 50, 100 and 200 ppb marked a NOAEC, because because adverse histopathological findings in the upper respiratory tract were observed even at the lowest concentration. Thus, the LOAEC of the test material is 50 ppb. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e099647-d214-4327-95a4-446bc0fd94e6/documents/cf7870b9-928f-474f-86a0-738e55dde015_52db1a1a-7614-456a-be47-bb4003d0d376.html,,,,,, "3,3,6,6-tetramethoxy-2,7-dioxa-3,6-disilaoctane",18406-41-2," Several acute inhalation toxicity studies performed with the test material were available: An acute vapor inhalation limit test was conducted with Dow Corning® X1 -6145A Additive in the Sprague Dawley rat (Kolesar and Sibert, 1990). Male and female rats were exposed to 0 and 0.92 mg/L (83 ppm) of the test material for four hours. No mortality or apparent abnormalities were observed in the control or test group animals during the exposure or first day. however, within 24 hours, test animals exhibited labored breathing and exhaustion. All test group animals were sacrificed in a moribund condition approximately 24 hours after exposure. Gross pathological examination revealed treatment-related lung changes and gas distention of the digestive tract in both male and female animals. Additionally, several female animals exhibited lung mottling. These results suggest that Dow Corning® X1 -6145A Additive does pose a significant acute inhalation hazard (LC50< 0.92 mg/L corresponding to 83 ppm) under the conditions of this study. An acute and 14 -day repeated dose inhalation study was initiated to assess the inhalation toxicity and to determine the NOAEL of DOW CORNING® X1-6154A Additive in rats (Crofoot et al., 1993). The study consisted of both an acute and repeated dose phase. Eight groups of five rats/sex were exposed acutely for six hours to target concentrations of 0, 0.5, 1.0 and 2.0 ppm of the test material. Four groups, one from each concentration level, were sacrificed immediately following exposure. The remaining groups were scheduled to be sacrificed following a 14 -day recovery period. All rats in the acute phase, which were scheduled for immediate sacrifice, survived the exposure. Three rats, two male and one female, from the acute recovery phase died in the 2.0 ppm group. The remaining animals in this group were sacrificed in moribund state two days post-exposure. All other rats in the acute recovery phase survived to the scheduled sacrifice. Clinical signs of toxicity which were considered treatment-related included ocular and nasal discharge, facial soiling, rough coats, soft feces, lethargy and labored breathing. A statistically significant decrease in body weights was seen in male rats in the 0.5 and 1.0 ppm groups of the acute recovery phase. Gross pathologic examination indicated that there were no test article-related lesions at necropsy in any of the rats from the acute phase which were sacrificed immediately after exposure. Histopathologic examination of tissues, however, indicated necrosis of respiratory epithelium of the nasal cavity in rats in the 1.0 and 2.0 ppm groups. Test article-related necrosis of the tracheal epithelium was also noted in these groups. No test article-related microscopic changes were observed in the respiratory tract or other organs examined in the 0.5 ppm group. In the acute recovery phase, corneal opacity and a decrease in thymus size was noted in some animals in the 0.5 and 1.0 ppm groups. Several organs had test article-related effects, these included the eye and various levels of the respiratory tract. As in the acute immediate sacrifice phase of this study, necrosis of the respiratory epithelium of the nasal cavity was evident. An acute vapor inhalation toxicity study (key study) was conducted to determine the four hour LC50 for DOW CORNING® X1-6154A Additive in Fischer 344/H rats (Siddiqui and Kolesar, 1993). Four groups of ten animals (5/sex/group) were exposed for four hours to target concentrations of 0.5, 2.0, 4.0 and 6.0 ppm. The animals were observed for 23 days following the exposures. The actual exposure concentrations, as determined by the Analect Diamond 20 FT-IR analyzer, were 0.4, 2.0, 2.6 and 5.7 ppm. All animals died at the highest exposure concentration. One female rat died at 2.0 ppm and seven rats (5 males and 2 females) died at 2.6 ppm. Test article-related clinical signs of toxicity were observed in all exposure groups. The primary clinical signs observed included nasal discharge, mouth breathing, rales and labored breathing. The severity of effects was the function of the exposure concentration. None of the animals exposed to 0.4 ppm had any gross lesions. Gross necropsy observations of animals that died during the study consisted of severe upper respiratory tract irritation and corneal opacity. Corneal opacity was the only gross lesion that occurred to animals in the other exposure groups that survived the observation period. The LC50 was determined to be 2.4 ppm. The study by Siddiqui and Kolesar, 1993, is considered the key study for the endpoint of acute toxicity because it allowed for determination of a LC50. The results of the two other available studies (Kolesar and Sibert, 1990; Crofoot et al., 1993) do not contradict the LC50 of 2.4 ppm from the Siddiqui and Kolesar (1993) study and deliver supplementary information for exposure at higher and lower concentrations and, in part, different exposure durations. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e099647-d214-4327-95a4-446bc0fd94e6/documents/5d4000c0-6564-47ae-9af3-f2a8097e8eb0_52db1a1a-7614-456a-be47-bb4003d0d376.html,,,,,, "3,3-[(2,2-dimethylpropane-1,3-diyl)bis(oxy)]-17α-hydroxyestr-5(10)-ene-17-carbonitrile",94291-97-1,"LD50 oral (rat): > 2000 mg/kg bw [Draft report, Lewin 2001a]LD50 dermal (rat): > 2000 mg/kg bw [Draft report, Lewin 2001b] ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b65875f0-3845-42ca-b9e4-b8e57c0c6649/documents/IUC5-72be1e39-547a-4ec4-8214-714123dff9db_d4d917fd-38c6-4949-bd66-db388f75f930.html,,,,,, "3,3-[(2,2-dimethylpropane-1,3-diyl)bis(oxy)]-17α-hydroxyestr-5(10)-ene-17-carbonitrile",94291-97-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b65875f0-3845-42ca-b9e4-b8e57c0c6649/documents/IUC5-72be1e39-547a-4ec4-8214-714123dff9db_d4d917fd-38c6-4949-bd66-db388f75f930.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3,3-[(2,2-dimethylpropane-1,3-diyl)bis(oxy)]-17α-hydroxyestr-5(10)-ene-17-carbonitrile",94291-97-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b65875f0-3845-42ca-b9e4-b8e57c0c6649/documents/IUC5-72be1e39-547a-4ec4-8214-714123dff9db_d4d917fd-38c6-4949-bd66-db388f75f930.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3,3'-[(2,5-dichloro-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]",5580-58-5,Oral:  subacute (28-days): NOAEL = 1000 mg/kg bw/day (OECD 407); read-across with CAS 5580-57-4 subacute (screening): NOAEL = 1000 mg/kg bw/day (OECD 422); read-across with CAS 68516-73-4 and 79953-85-8   Inhalative: subacute (5 d): NOAEC (local) = 5 mg/m³ air; NOAEC (systemic) = 60 mg/m³ air; read-across with CAS 79953-85-8   ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/740db5f8-cef8-49b5-8b15-b1d52cf2e518/documents/f9c1e40e-766e-465b-9b5a-5ba8846debf7_13643f57-02a5-4b68-b91a-2f85bee583da.html,,,,,, "3,3'-[(2,5-dichloro-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]",5580-58-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/740db5f8-cef8-49b5-8b15-b1d52cf2e518/documents/f9c1e40e-766e-465b-9b5a-5ba8846debf7_13643f57-02a5-4b68-b91a-2f85bee583da.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,3'-[(2,5-dichloro-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]",5580-58-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/740db5f8-cef8-49b5-8b15-b1d52cf2e518/documents/f9c1e40e-766e-465b-9b5a-5ba8846debf7_13643f57-02a5-4b68-b91a-2f85bee583da.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,60 mg/m3,,rat "3,3'-[(2,5-dichloro-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]",5580-58-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/740db5f8-cef8-49b5-8b15-b1d52cf2e518/documents/f9c1e40e-766e-465b-9b5a-5ba8846debf7_13643f57-02a5-4b68-b91a-2f85bee583da.html,Repeated dose toxicity – local effects,inhalation,LOAEC,5 mg/m3,adverse effect observed,rat "3,3'-[(2,5-dichloro-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]",5580-58-5,"Category assessment:Oral: LD50 > 2000 mg/kg bw/day, OECD 401Dermal: LD50 > 5000 mg/kg bw/dayInhalative (dust): LC50 (4h, rat) > 1.7 mg/L air (highest concentration possible), OECD 403 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/740db5f8-cef8-49b5-8b15-b1d52cf2e518/documents/2978ec41-f71e-40e8-a55e-9d5b4a48a712_13643f57-02a5-4b68-b91a-2f85bee583da.html,,,,,, "3,3'-[(2,5-dichloro-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]",5580-58-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/740db5f8-cef8-49b5-8b15-b1d52cf2e518/documents/2978ec41-f71e-40e8-a55e-9d5b4a48a712_13643f57-02a5-4b68-b91a-2f85bee583da.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3,3'-[(2,5-dichloro-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]",5580-58-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/740db5f8-cef8-49b5-8b15-b1d52cf2e518/documents/2978ec41-f71e-40e8-a55e-9d5b4a48a712_13643f57-02a5-4b68-b91a-2f85bee583da.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "3,3'-[(2,5-dichloro-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]",5580-58-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/740db5f8-cef8-49b5-8b15-b1d52cf2e518/documents/2978ec41-f71e-40e8-a55e-9d5b4a48a712_13643f57-02a5-4b68-b91a-2f85bee583da.html,,inhalation,discriminating conc.,"1,700 mg/m3",no adverse effect observed, "3,3'-[(2,5-dimethyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]",5280-80-8, Oral:  subacute (28-days): NOAEL = 1000 mg/kg bw/day (OECD 407); read-across with CAS 5580-57-4 subacute (screening): NOAEL = 1000 mg/kg bw/day (OECD 422); read-across with CAS 68516-73-4 and 79953-85-8   Inhalative: subacute (5 d): LOAEC (local) = 5 mg/m³ air; NOEAC (systemic) = 60 mg/m³ air; read-across with CAS 79953-85-8   ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4fdef224-93c9-46a2-a1d3-022a85205f8f/documents/02d0adfe-2eab-4e67-8770-dd354a550d58_b3a9f918-737a-4ec4-8d11-4161629a03bb.html,,,,,, "3,3'-[(2,5-dimethyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]",5280-80-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4fdef224-93c9-46a2-a1d3-022a85205f8f/documents/02d0adfe-2eab-4e67-8770-dd354a550d58_b3a9f918-737a-4ec4-8d11-4161629a03bb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,3'-[(2,5-dimethyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]",5280-80-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4fdef224-93c9-46a2-a1d3-022a85205f8f/documents/02d0adfe-2eab-4e67-8770-dd354a550d58_b3a9f918-737a-4ec4-8d11-4161629a03bb.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,60 mg/m3,,rat "3,3'-[(2,5-dimethyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]",5280-80-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4fdef224-93c9-46a2-a1d3-022a85205f8f/documents/02d0adfe-2eab-4e67-8770-dd354a550d58_b3a9f918-737a-4ec4-8d11-4161629a03bb.html,Repeated dose toxicity – local effects,inhalation,LOAEC,5 mg/m3,adverse effect observed,rat "3,3'-[(2,5-dimethyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]",5280-80-8," Oral: LD50 > 5000 mg/kg bw/day, OECD 401 Dermal: LD50 > 5000 mg/kg bw/day and additional read-across (CAS 5580-57-4): LD50 > 5000 mg/kg bw/day Inhalative (dust): Read-across (CAS 5580-57-4): LC50 (4h, rat) > 1.7 mg/L air (highest concentration possible), OECD 403 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fdef224-93c9-46a2-a1d3-022a85205f8f/documents/0b02b5db-7f9e-41fd-9301-ef0166c9597c_b3a9f918-737a-4ec4-8d11-4161629a03bb.html,,,,,, "3,3'-[(2,5-dimethyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]",5280-80-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fdef224-93c9-46a2-a1d3-022a85205f8f/documents/0b02b5db-7f9e-41fd-9301-ef0166c9597c_b3a9f918-737a-4ec4-8d11-4161629a03bb.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,3'-[(2,5-dimethyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]",5280-80-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fdef224-93c9-46a2-a1d3-022a85205f8f/documents/0b02b5db-7f9e-41fd-9301-ef0166c9597c_b3a9f918-737a-4ec4-8d11-4161629a03bb.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,3'-[(2,5-dimethyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(5-chloro-o-tolyl)benzamide]",5280-80-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fdef224-93c9-46a2-a1d3-022a85205f8f/documents/0b02b5db-7f9e-41fd-9301-ef0166c9597c_b3a9f918-737a-4ec4-8d11-4161629a03bb.html,,inhalation,LC50,"1,700 mg/m3",no adverse effect observed, "3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(3-chloro-o-tolyl)benzamide]",5580-57-4, oral:  subacute (28-days): NOAEL = 1000 mg/kg bw/day (OECD 407)  ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/889b1d5c-ff99-494e-a2a7-c7709ba0a984/documents/5b159c9b-81c3-443f-9d1e-6dc80221d9d1_feafd895-ff42-476a-a02a-d5964ea1d464.html,,,,,, "3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(3-chloro-o-tolyl)benzamide]",5580-57-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/889b1d5c-ff99-494e-a2a7-c7709ba0a984/documents/5b159c9b-81c3-443f-9d1e-6dc80221d9d1_feafd895-ff42-476a-a02a-d5964ea1d464.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(3-chloro-o-tolyl)benzamide]",5580-57-4,"Oral: LD50 > 2000 mg/kg bw/day, OECD 401Dermal: LD50 > 5000 mg/kg bw/dayInhalative (dust): LC50 (4h, rat) > 1.7 mg/L air (highest concentration possible), OECD 403 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/889b1d5c-ff99-494e-a2a7-c7709ba0a984/documents/8aa3ac08-84a0-4c46-aee2-22651ca4a520_feafd895-ff42-476a-a02a-d5964ea1d464.html,,,,,, "3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(3-chloro-o-tolyl)benzamide]",5580-57-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/889b1d5c-ff99-494e-a2a7-c7709ba0a984/documents/8aa3ac08-84a0-4c46-aee2-22651ca4a520_feafd895-ff42-476a-a02a-d5964ea1d464.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(3-chloro-o-tolyl)benzamide]",5580-57-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/889b1d5c-ff99-494e-a2a7-c7709ba0a984/documents/8aa3ac08-84a0-4c46-aee2-22651ca4a520_feafd895-ff42-476a-a02a-d5964ea1d464.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-(3-chloro-o-tolyl)benzamide]",5580-57-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/889b1d5c-ff99-494e-a2a7-c7709ba0a984/documents/8aa3ac08-84a0-4c46-aee2-22651ca4a520_feafd895-ff42-476a-a02a-d5964ea1d464.html,,inhalation,discriminating conc.,"1,700 mg/m3",no adverse effect observed, "3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-[2-(4-chlorophenoxy)-5-(trifluoromethyl)phenyl]benzamide]",79953-85-8, oral:  subacute (OECD 422): NOAEL = 1000 mg/kg bw (ERBC 2022) inhalation NOAEC = 5 mg/m3 (Short-Termin inhalation study with recovery and BALF) ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/441b2212-7c4c-4908-95d8-9f4dcbb890c0/documents/c48bda58-7a61-4acc-bd29-29f638cfe58b_f450e442-f24e-4dea-b0e1-86f9f19f0c05.html,,,,,, "3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-[2-(4-chlorophenoxy)-5-(trifluoromethyl)phenyl]benzamide]",79953-85-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/441b2212-7c4c-4908-95d8-9f4dcbb890c0/documents/c48bda58-7a61-4acc-bd29-29f638cfe58b_f450e442-f24e-4dea-b0e1-86f9f19f0c05.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-[2-(4-chlorophenoxy)-5-(trifluoromethyl)phenyl]benzamide]",79953-85-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/441b2212-7c4c-4908-95d8-9f4dcbb890c0/documents/c48bda58-7a61-4acc-bd29-29f638cfe58b_f450e442-f24e-4dea-b0e1-86f9f19f0c05.html,Repeated dose toxicity – local effects,inhalation,NOAEC,5 mg/m3,adverse effect observed,rat "3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-[2-(4-chlorophenoxy)-5-(trifluoromethyl)phenyl]benzamide]",79953-85-8," Oral: LD50 > 2000 mg/kg bw/day, OECD 401 Dermal: No data available. LD50 > 5000 mg/kg bw/day for CAS 5580-57-4 and CAS 5280-80-8 Inhalative (dust): LC50 (4h, rat) > 1.7 mg/L air (highest concentration possible), similar to OECD 403; read acorss with CAS 5580-57-4 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/441b2212-7c4c-4908-95d8-9f4dcbb890c0/documents/4dfaf784-2941-4e86-a0c4-49b864a55c16_f450e442-f24e-4dea-b0e1-86f9f19f0c05.html,,,,,, "3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-[2-(4-chlorophenoxy)-5-(trifluoromethyl)phenyl]benzamide]",79953-85-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/441b2212-7c4c-4908-95d8-9f4dcbb890c0/documents/4dfaf784-2941-4e86-a0c4-49b864a55c16_f450e442-f24e-4dea-b0e1-86f9f19f0c05.html,,oral,discriminating dose,"7,750 mg/kg bw",no adverse effect observed, "3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-[2-(4-chlorophenoxy)-5-(trifluoromethyl)phenyl]benzamide]",79953-85-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/441b2212-7c4c-4908-95d8-9f4dcbb890c0/documents/4dfaf784-2941-4e86-a0c4-49b864a55c16_f450e442-f24e-4dea-b0e1-86f9f19f0c05.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "3,3'-[(2-chloro-5-methyl-p-phenylene)bis[imino(1-acetyl-2-oxoethylene)azo]]bis[4-chloro-N-[2-(4-chlorophenoxy)-5-(trifluoromethyl)phenyl]benzamide]",79953-85-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/441b2212-7c4c-4908-95d8-9f4dcbb890c0/documents/4dfaf784-2941-4e86-a0c4-49b864a55c16_f450e442-f24e-4dea-b0e1-86f9f19f0c05.html,,inhalation,discriminating conc.,"1,700 mg/m3",no adverse effect observed, "3,3'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[N-cyclohexyl-2,4,6-trimethylbenzenesulphonamide]",23552-74-1,Single treatment of rats via oral or dermal routes did not cause any adverse effect. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1d50c45-4223-426e-8faa-ee4cf81a4b5e/documents/IUC5-236121b9-dd99-4d22-aaaa-e9d24ecb4727_dafa2985-f8ca-4c02-8f12-1ccc357a166e.html,,,,,, "3,3'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[N-cyclohexyl-2,4,6-trimethylbenzenesulphonamide]",23552-74-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1d50c45-4223-426e-8faa-ee4cf81a4b5e/documents/IUC5-236121b9-dd99-4d22-aaaa-e9d24ecb4727_dafa2985-f8ca-4c02-8f12-1ccc357a166e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,3'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[N-cyclohexyl-2,4,6-trimethylbenzenesulphonamide]",23552-74-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1d50c45-4223-426e-8faa-ee4cf81a4b5e/documents/IUC5-236121b9-dd99-4d22-aaaa-e9d24ecb4727_dafa2985-f8ca-4c02-8f12-1ccc357a166e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,3'-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]imino]bis[propiononitrile]",4058-30-4,LD50 > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fb168fd-a7a8-4caa-8f60-7d0d779ce8c5/documents/IUC5-0a4ad3f2-c8da-42b8-9e91-21607fed0a5e_91497466-de69-4c8e-aec9-3b5835d5e391.html,,,,,, "3,3'-[butane-1,4-diylbis(oxy)]bispropanamine",7300-34-7,"OECD 422, rat, gavage with structural analogue 3,3'-oxybis(ethyleneoxy)bis(propylamine), CAS 4246-51-9 (BASF SE, 2013):NOAEL systemic parental toxicity: 600 mg/kg bw/d (highest dose tested)NOAEL reproduction toxicity: 600 mg/kg bw/d (highest dose tested)NOAEL developmental toxicity: 600 mg/kg bw/d (highest dose tested)LOAEL local irritating effect (stomach): 100 mg/kg bw/d ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3bf3fd3d-362c-4667-a19a-426fadd68e03/documents/IUC5-00195e20-28f0-4bf7-818a-31a051480058_08f4fdc2-0dc4-40e0-9815-c79828ba96b7.html,,,,,, "3,3'-[butane-1,4-diylbis(oxy)]bispropanamine",7300-34-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3bf3fd3d-362c-4667-a19a-426fadd68e03/documents/IUC5-00195e20-28f0-4bf7-818a-31a051480058_08f4fdc2-0dc4-40e0-9815-c79828ba96b7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat "3,3'-[butane-1,4-diylbis(oxy)]bispropanamine",7300-34-7,"LD50 oral = 3450 mg/kg (BASF, 1972; OECD401)LC50 inhalation (4h, aerosol) = 1.5 mg/L (BASF1980; OECD403)LD50 dermal > 1000 (male ) and > 2000 mg/kg (female) (BASF 2001; OECD402) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bf3fd3d-362c-4667-a19a-426fadd68e03/documents/IUC5-f0fb5ca9-c4f8-4a26-af61-8d4fc2f77e91_08f4fdc2-0dc4-40e0-9815-c79828ba96b7.html,,,,,, "3,3'-[butane-1,4-diylbis(oxy)]bispropanamine",7300-34-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bf3fd3d-362c-4667-a19a-426fadd68e03/documents/IUC5-f0fb5ca9-c4f8-4a26-af61-8d4fc2f77e91_08f4fdc2-0dc4-40e0-9815-c79828ba96b7.html,,oral,LD50,"3,450 mg/kg bw",adverse effect observed, "3,3'-[butane-1,4-diylbis(oxy)]bispropanamine",7300-34-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bf3fd3d-362c-4667-a19a-426fadd68e03/documents/IUC5-f0fb5ca9-c4f8-4a26-af61-8d4fc2f77e91_08f4fdc2-0dc4-40e0-9815-c79828ba96b7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,3'-[butane-1,4-diylbis(oxy)]bispropanamine",7300-34-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bf3fd3d-362c-4667-a19a-426fadd68e03/documents/IUC5-f0fb5ca9-c4f8-4a26-af61-8d4fc2f77e91_08f4fdc2-0dc4-40e0-9815-c79828ba96b7.html,,inhalation,LC50,"1,500 mg/m3",adverse effect observed, "3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane",60111-54-8,"In the key repeated dose 90-day oral toxicity study, conducted according to OECD Test Guideline 408 and in compliance with GLP, the NOAEL for systemic toxicity was concluded to be greater than or equal to 1000 mg/kg bw/day (the highest dose tested) based on no adverse systemic effects (Charles River Laboratories, 2020a, reliability 1). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a387d86-c621-481c-90a0-76c8a894f32a/documents/6bd0e57d-cba0-41f5-bec4-6e5b2a98bc5f_d2ce170c-2737-4cc9-a7bf-1b0f36d7fbdc.html,,,,,, "3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane",60111-54-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a387d86-c621-481c-90a0-76c8a894f32a/documents/6bd0e57d-cba0-41f5-bec4-6e5b2a98bc5f_d2ce170c-2737-4cc9-a7bf-1b0f36d7fbdc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane",60111-54-8,"In the key acute oral toxicity study with tetra(dimethylvinylsiloxy)silane (CAS 60111-54-8, EC 262-061-1) in female rats, conducted according to the OECD Test Guideline 423 and in compliance with GLP, the LD50 was determined to be >5000 mg/kg bw (NOTOX, 2011a, reliability 1).     In the key acute dermal toxicity study with the registered substance in rats, conducted according to OECD Test Guideline 402 and in compliance with GLP, the LD50 was determined to be >2000 mg/kg bw in rats (Harlan, 2012, reliability 1).     In accordance with REACH Annex VIIII (Section 8.5), the acute inhalation study does not need to be conducted since reliable data via the oral and dermal routes are available. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a387d86-c621-481c-90a0-76c8a894f32a/documents/4f099668-b122-4ef4-ba7b-2331a88d70ce_d2ce170c-2737-4cc9-a7bf-1b0f36d7fbdc.html,,,,,, "3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane",60111-54-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a387d86-c621-481c-90a0-76c8a894f32a/documents/4f099668-b122-4ef4-ba7b-2331a88d70ce_d2ce170c-2737-4cc9-a7bf-1b0f36d7fbdc.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "3,3-bis[(dimethylvinylsilyl)oxy]-1,1,5,5-tetramethyl-1,5-divinyltrisiloxane",60111-54-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a387d86-c621-481c-90a0-76c8a894f32a/documents/4f099668-b122-4ef4-ba7b-2331a88d70ce_d2ce170c-2737-4cc9-a7bf-1b0f36d7fbdc.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea",58890-25-8,In an 28-day toxicity study there were no adverse effects observed. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed94480a-06ed-47dc-9f03-06b294e66a92/documents/IUC5-f23348b2-05c8-4bde-9c06-59ba2f708cd1_23f28b94-0221-4447-b3ad-8f09b693c6ce.html,,,,,, "3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea",58890-25-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed94480a-06ed-47dc-9f03-06b294e66a92/documents/IUC5-f23348b2-05c8-4bde-9c06-59ba2f708cd1_23f28b94-0221-4447-b3ad-8f09b693c6ce.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea",58890-25-8,In an acute oral and in an acute dermal toxicity study the LD50 was determined to be >2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed94480a-06ed-47dc-9f03-06b294e66a92/documents/IUC5-79f88e80-fb66-497c-9e76-2a5879006f7e_23f28b94-0221-4447-b3ad-8f09b693c6ce.html,,,,,, "3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea",58890-25-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed94480a-06ed-47dc-9f03-06b294e66a92/documents/IUC5-79f88e80-fb66-497c-9e76-2a5879006f7e_23f28b94-0221-4447-b3ad-8f09b693c6ce.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,3'-dicyclohexyl-1,1'-methylenebis(4,1-phenylene)diurea",58890-25-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed94480a-06ed-47dc-9f03-06b294e66a92/documents/IUC5-79f88e80-fb66-497c-9e76-2a5879006f7e_23f28b94-0221-4447-b3ad-8f09b693c6ce.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,3'-dimethylbiphenyl-4,4'-diyl diisocyanate",91-97-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP and guideline conform study ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/178bbdfb-37e6-43a5-bab0-dd4cd6d259bf/documents/e53145ca-2dd5-471e-85a7-7090e5d8144f_b263264a-c925-438b-9bc3-dd70e242549f.html,,,,,, "3,3'-dimethylbiphenyl-4,4'-diyl diisocyanate",91-97-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/178bbdfb-37e6-43a5-bab0-dd4cd6d259bf/documents/e53145ca-2dd5-471e-85a7-7090e5d8144f_b263264a-c925-438b-9bc3-dd70e242549f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "3,3'-dimethylbiphenyl-4,4'-diyl diisocyanate",91-97-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP and guideline compliant Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): GLP and guideline compliant Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): GLP and guideline compliant ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/178bbdfb-37e6-43a5-bab0-dd4cd6d259bf/documents/ccb2820f-fb48-451e-9c0c-f2755cfac727_b263264a-c925-438b-9bc3-dd70e242549f.html,,,,,, "3,3'-dimethylbiphenyl-4,4'-diyl diisocyanate",91-97-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/178bbdfb-37e6-43a5-bab0-dd4cd6d259bf/documents/ccb2820f-fb48-451e-9c0c-f2755cfac727_b263264a-c925-438b-9bc3-dd70e242549f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,3'-dimethylbiphenyl-4,4'-diyl diisocyanate",91-97-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/178bbdfb-37e6-43a5-bab0-dd4cd6d259bf/documents/ccb2820f-fb48-451e-9c0c-f2755cfac727_b263264a-c925-438b-9bc3-dd70e242549f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,3'-dimethylbiphenyl-4,4'-diyl diisocyanate",91-97-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/178bbdfb-37e6-43a5-bab0-dd4cd6d259bf/documents/ccb2820f-fb48-451e-9c0c-f2755cfac727_b263264a-c925-438b-9bc3-dd70e242549f.html,,inhalation,LC50,"2,006 mg/m3",adverse effect observed, "3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea",43136-14-7, A short-term repeat oral toxicity study was conducted with the test item over 28 days with 7 days/week dosing at three concentrations up to 1000 mg/kg bw/day. No treatment related findings were observed at any of the nominal concentrations tested and therefore the NOAEL and NOEL was determined to be 1000 mg/kg/b.w. day. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29f39850-0d71-47b3-8789-04fb119299c1/documents/9f12421f-a9bd-4856-93da-f84ec5f94153_8a3e471f-b549-4b3a-b7b7-5c92c872e2c6.html,,,,,, "3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea",43136-14-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29f39850-0d71-47b3-8789-04fb119299c1/documents/9f12421f-a9bd-4856-93da-f84ec5f94153_8a3e471f-b549-4b3a-b7b7-5c92c872e2c6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea",43136-14-7," An acute oral toxicity study was performed with the test item with Wistar rats. The results from this study showed no evidence of acute toxicity at the only dose tested (5000 mg/kg test item). In an acute dermal toxicity study, there was no evidence of acute toxicity at the only concentration tested (2000 mg/kg test item). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29f39850-0d71-47b3-8789-04fb119299c1/documents/1dceb732-037c-48ce-9344-4e570138639c_8a3e471f-b549-4b3a-b7b7-5c92c872e2c6.html,,,,,, "3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea",43136-14-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29f39850-0d71-47b3-8789-04fb119299c1/documents/1dceb732-037c-48ce-9344-4e570138639c_8a3e471f-b549-4b3a-b7b7-5c92c872e2c6.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,3'-dioctadecyl-1,1'-methylenebis(4,1-phenylene)diurea",43136-14-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29f39850-0d71-47b3-8789-04fb119299c1/documents/1dceb732-037c-48ce-9344-4e570138639c_8a3e471f-b549-4b3a-b7b7-5c92c872e2c6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,3'-ethylenedioxybis(propylamine)",2997-01-5," No reliable acute toxicity studies via the oral route are available for the test substance. However, as the substance is classified as corrosive to the skin, studes for the acute toxicity endpoint are waived (column 2, annex VII, REACH Regulation). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acb17309-de92-40ab-9ad1-e89190cab987/documents/393e5a5c-58d7-490a-b90b-e27f6d646ecf_dc61a4d8-1f3c-437e-9da7-81166297d026.html,,,,,, "3,3'-methylenebis[5-methyloxazolidine]",66204-44-2,"No data are available on effects of the substance after repeated dermal and inhalation exposure.In a 90-Day subchronic gavage study in rats according to OECD guideline 408 (Rajesh 2001) slight effects on body weight gain and alterations in clinical chemistry in males of the high dose group have been detected. These data suggested a LOAEL of 180 mg/kg bw/day. However, concerning clinical chemistry parameters no historical control data of this laboratory were given. The toxicological relevance of other effects was questionable. No local effects in the stomach were found although such effects are expected. These data suggest that the MTD was not reached in this study. Furthermore, pulmonary infection due to Mycoplasma spec. has been detected in all groups including controls. Altogether, this study has limitations. In a 2nd 90-Day subchronic gavage study in rats (OECD guideline 408; Leuschner 2002) the test substance induced local effects in the stomach at a dose level of ≥ 60 mg/kg bw. Other effects at the mid and high dose level (% of granulocyes increased, % of lymphocytes decreased), are considered to be a consequence of this chronic ulcerative gastritis & peritonitis. The toxicological relevance of the reduced pupil size detected in males and females of the high dose group is not clear. The dose levels of 0, 20, 60, 180/120 mg/kg bw/day correspond to a concentration of 0, 0.4, 1.2, 3.6/2.4% in corn oil. Effects in the stomach were detected at a concentration of 1.2%. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31a11d52-c0d3-48f1-8a7a-aa3165591956/documents/3d2a4d3f-b277-4e1f-be49-9836391f2cec_8fefaa1c-c901-4702-a476-def95a94ca31.html,,,,,, "3,3'-methylenebis[5-methyloxazolidine]",66204-44-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31a11d52-c0d3-48f1-8a7a-aa3165591956/documents/3d2a4d3f-b277-4e1f-be49-9836391f2cec_8fefaa1c-c901-4702-a476-def95a94ca31.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "3,3'-methylenebis[5-methyloxazolidine]",66204-44-2," The acute toxicity after oral, inhalation and dermal exposure has been investigated in valid studies on rats. The oral LD50 ranged from 630 (Leuschner 2002) to 900 mg/kg bw (Leuschner 1979). Clinical signs observed in rats after oral application were sedation, ataxia and dyspnea 5-10 minutes after application followed by coma and death. Pathology revealed no treatment related effects. Similar results were reported in two further oral studies (surprisingly no local effects detected). The LC50 after inhalation exposure for 4h was >1000 mg/m3 (Fraunhofer ITEM 2010) and the cut-off value of 2000 mg/m3 will be used according to OECD Guideline and GHS. The dermal LD50 in rats ranged from 760 to 1400 mg/kg bw (Leuschner 2002, Stephen 2000). Lethargy, local erythema, abdominal breathing, nostril discharge and piloerection on day 1 and 2 were reported after acute dermal exposure and at higher dose levels additionally tremor and gasping. The local skin effects (necrosis) were not reversible within 14 days (Stephen, 2000). Similar results were presented by Leuschner 2002. In both studies no treatment-related findings were detected at necropsy except local effects (scab formation). Clinical signs after application and the dose-effect-level suggested similar absorption pattern of the test substance after oral and dermal exposure (presuming that effects are not exclusively secondary to local necrosis after dermal application). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31a11d52-c0d3-48f1-8a7a-aa3165591956/documents/75d7dd64-4ca8-4e8d-9016-441d6b537442_8fefaa1c-c901-4702-a476-def95a94ca31.html,,,,,, "3,3'-methylenebis[5-methyloxazolidine]",66204-44-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31a11d52-c0d3-48f1-8a7a-aa3165591956/documents/75d7dd64-4ca8-4e8d-9016-441d6b537442_8fefaa1c-c901-4702-a476-def95a94ca31.html,,oral,LD50,630 mg/kg bw,adverse effect observed, "3,3'-methylenebis[5-methyloxazolidine]",66204-44-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31a11d52-c0d3-48f1-8a7a-aa3165591956/documents/75d7dd64-4ca8-4e8d-9016-441d6b537442_8fefaa1c-c901-4702-a476-def95a94ca31.html,,dermal,LD50,760 mg/kg bw,adverse effect observed, "3,3'-methylenebis[5-methyloxazolidine]",66204-44-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31a11d52-c0d3-48f1-8a7a-aa3165591956/documents/75d7dd64-4ca8-4e8d-9016-441d6b537442_8fefaa1c-c901-4702-a476-def95a94ca31.html,,inhalation,LC50,"2,000 mg/m3",no adverse effect observed, "3,3'-sulphonyldianiline",599-61-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The whole database is excellent, because dapsone has a dual use as an industrial chemical and a pharmaceutical. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a524fa2f-9288-4494-8860-a967d1652577/documents/c643bbb0-4957-4860-81cc-fed31c571657_593a80e5-d8fc-4d00-83db-da4c5f7c6f46.html,,,,,, "3,3'-sulphonyldianiline",599-61-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a524fa2f-9288-4494-8860-a967d1652577/documents/c643bbb0-4957-4860-81cc-fed31c571657_593a80e5-d8fc-4d00-83db-da4c5f7c6f46.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,3 mg/kg bw/day,,rat "3,3'-sulphonyldianiline",599-61-1," Based on available data, the median lethal dose via the oral and dermal route for the source substance, dapsone, is >250 and >2000 mg/kg bw respectively. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a524fa2f-9288-4494-8860-a967d1652577/documents/fae2906a-0608-4fe6-8016-7fb6135be37e_593a80e5-d8fc-4d00-83db-da4c5f7c6f46.html,,,,,, "3,3'-sulphonyldianiline",599-61-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a524fa2f-9288-4494-8860-a967d1652577/documents/fae2906a-0608-4fe6-8016-7fb6135be37e_593a80e5-d8fc-4d00-83db-da4c5f7c6f46.html,,oral,LD50,> 250 mg/kg bw,adverse effect observed, "3,3'-sulphonyldianiline",599-61-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a524fa2f-9288-4494-8860-a967d1652577/documents/fae2906a-0608-4fe6-8016-7fb6135be37e_593a80e5-d8fc-4d00-83db-da4c5f7c6f46.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "3,3-Tetramethyleneglutarimide sodium salt",105920-64-7," The acute oral toxicity of the test item Natrium-3,3-Tetramethyleneglutarimide (3,3-Tetramethyleneglutarimide sodium salt) was evaluated in female Sprague Dawley rats according to OECD 423, EU Method B.1 tris and EPA (OPPTS) 870.1000 and 870.1100 guidelines and in compliance with GLP. The test substance induced mortality in the rat following oral administration of a single dose at levels of 2000, 300 and 50 mg/kg. Main clinical sings after 2000, 300 and 50 mg/kg doses were convulsions and piloerection. Gross pathology examination showed abnormal colour of the jejunum and/or duodenum, liver, lungs, brain, pituitary and mesenteric lymph nodes and abnormal contents in the stomach, jejunum and/or ileum and/or duodenum and abnormal areas in the stomach and thymus for animals died during the study. No mortality occurred at dose 5 mg/kg. Main clinical sings after 5 mg/kg dose were ataxia and piloerection. The results suggest the LD50 to be > 5 - < 50 mg/kg bw and indicate the classification of Acute Oral Toxicity Category 2. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e219943-cfed-433e-92b7-a12d2d37678a/documents/2f1053d7-b604-4f27-a5ac-d3808fe79c3c_9b778b24-e484-4fb8-a801-42b144ae0415.html,,,,,, "3,3-Tetramethyleneglutarimide sodium salt",105920-64-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e219943-cfed-433e-92b7-a12d2d37678a/documents/2f1053d7-b604-4f27-a5ac-d3808fe79c3c_9b778b24-e484-4fb8-a801-42b144ae0415.html,,oral,LD50,27.5 mg/kg bw,adverse effect observed, "3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran",32539-83-6,"Acute oral toxicity (OECD401, GLP, K1, 1984): The acute oral median lethal dose (LD50) of the test item to the rat was found to be greater than 2000 mg/kg bodyweight. Acute dermal toxicity (OECD402, GLP, K1, 2000): The acute dermal median lethal dose (LD50) of the test material, in the Sprague-Dawley CD (Crl:CD(R) (SD) IGS BR) strain rat was found to be greater than 2000 mg/kg bodyweight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/925f8571-a5b9-4609-82b3-2ec74747218d/documents/b22f12bc-e54e-4b27-ba73-3ae511abc6aa_6219ebac-1a15-4293-a2c3-9ef4f1465030.html,,,,,, "3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran",32539-83-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/925f8571-a5b9-4609-82b3-2ec74747218d/documents/b22f12bc-e54e-4b27-ba73-3ae511abc6aa_6219ebac-1a15-4293-a2c3-9ef4f1465030.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "3,4,5,6,7,8,9,10,11,12,13,14-dodecahydro-2H-cyclododeca[b]pyran",32539-83-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/925f8571-a5b9-4609-82b3-2ec74747218d/documents/b22f12bc-e54e-4b27-ba73-3ae511abc6aa_6219ebac-1a15-4293-a2c3-9ef4f1465030.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "3,4,5,6-tetrachloro-2-(2,4,5,7-tetrabromo-3,6-dihydroxyxanthen-9-yl)benzoic acid, aluminium salt",84473-86-9," Repeated dose toxicity: Oral Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for 3,4,5,6-tetrachloro-2-(2,4,5,7-tetrabromo-3,6-dihydroxyxanthen-9-yl)benzoic acid, aluminium salt. The study assumed the use of male and female Wistar rats in Repeated Dose Toxicity Study for 13 weeks. Since no significant treatment related effects were observed, hence the No Observed Adverse Effect Level (NOAEL) for 3,4,5,6-tetrachloro-2-(2,4,5,7-tetrabromo-3,6-dihydroxyxanthen-9-yl)benzoic acid, aluminium salt is predicted to be 523.773681641 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. Repeated dose toxicity: Inhalation 3,4,5,6-tetrachloro-2-(2,4,5,7-tetrabromo-3,6-dihydroxyxanthen-9-yl)benzoic acid, aluminium salt has very low vapor pressure (4.49E-018 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver Repeated dose toxicity: Dermal The acute dermal toxicity value for 3,4,5,6-tetrachloro-2-(2,4,5,7-tetrabromo-3,6-dihydroxyxanthen-9-yl)benzoic acid, aluminium salt (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance is also found to be not irritating to skin. Based on these considerations, the end point is considered as waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6c846c9-4a83-4416-992d-14c9cd0a0c0b/documents/98fa7971-1a95-41b1-8190-1b11fd0500db_e0e5e404-d09a-4b22-8044-1ae12a8e2f60.html,,,,,, "3,4,5,6-tetrachloro-2-(2,4,5,7-tetrabromo-3,6-dihydroxyxanthen-9-yl)benzoic acid, aluminium salt",84473-86-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6c846c9-4a83-4416-992d-14c9cd0a0c0b/documents/98fa7971-1a95-41b1-8190-1b11fd0500db_e0e5e404-d09a-4b22-8044-1ae12a8e2f60.html,Chronic toxicity – systemic effects,oral,NOAEL,523.774 mg/kg bw/day,,rat "3,4,5,6-tetrachloro-2-(2,4,5,7-tetrabromo-3,6-dihydroxyxanthen-9-yl)benzoic acid, aluminium salt",84473-86-9," Acute Oral Toxicity:  Acute oral toxicity dose was predicted based on OECD QSAR toolbox for target substance3,4,5,6-tetrachloro-2-(2,4,5,7-tetrabromo-3,6-dihydroxyxanthen-9-yl)benzoic acid, aluminium salt (84473-86-9)was estimated to be 4566 mg/kg bw andfor differentstudies available on the closely related read across substance Niobium pentoxide (1313-96-8) was considered to be 4000 mg/kg bw for mouse and Dibismuth trisulphide (1345-07-9) was considered to be 5000 mg/kg bw for rats. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,3,4,5,6-tetrachloro-2-(2,4,5,7-tetrabromo-3,6-dihydroxyxanthen-9-yl)benzoic acid, aluminium salt (84473-86-9)can be classified as category V of acute oral toxicity. Acute Inhalation Toxicity:  3,4,5,6-tetrachloro-2-(2,4,5,7-tetrabromo-3,6-dihydroxyxanthen-9-yl)benzoic acid, aluminium salt has very low vapor pressure (4.49E-018 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal Toxicity: Acute dermal toxicity dose was predicted based on OECD QSAR toolbox for target substance substance3,4,5,6-tetrachloro-2-(2,4,5,7-tetrabromo-3,6-dihydroxyxanthen-9-yl)benzoic acid, aluminium salt (84473-86-9)was estimated to be 14289.59 mg/kg bw for rabbits andfor differentstudies available on the structurally similar read across substance 2',4',5',7'-tetrabromo-4,5,6,7-tetrachloro-3',6'-dihydroxy-3H-spiro[2-benzofuran-1,9'-xanthen]-3-one (18472-87-2) was considered to be >2000 mg/kg bw for rats and for the closely related read across substance 2,2',6,6',-tetrabromo-4,4'-isopropylidenediphenol (79-94-7) was considered to be >2000 mg/kg bw for rabbits. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,3,4,5,6-tetrachloro-2-(2,4,5,7-tetrabromo-3,6-dihydroxyxanthen-9-yl)benzoic acid, aluminium salt (84473-86-9)can be classified as category V of acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6c846c9-4a83-4416-992d-14c9cd0a0c0b/documents/c27cab24-bd89-471b-9b2e-e11be19ac767_e0e5e404-d09a-4b22-8044-1ae12a8e2f60.html,,,,,, "3,4,5,6-tetrachloro-2-(2,4,5,7-tetrabromo-3,6-dihydroxyxanthen-9-yl)benzoic acid, aluminium salt",84473-86-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6c846c9-4a83-4416-992d-14c9cd0a0c0b/documents/c27cab24-bd89-471b-9b2e-e11be19ac767_e0e5e404-d09a-4b22-8044-1ae12a8e2f60.html,,oral,LD50,"4,566 mg/kg bw",no adverse effect observed, "3,4,5,6-tetrachloro-2-(2,4,5,7-tetrabromo-3,6-dihydroxyxanthen-9-yl)benzoic acid, aluminium salt",84473-86-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6c846c9-4a83-4416-992d-14c9cd0a0c0b/documents/c27cab24-bd89-471b-9b2e-e11be19ac767_e0e5e404-d09a-4b22-8044-1ae12a8e2f60.html,,dermal,LD50,"14,289.59 mg/kg bw",no adverse effect observed, "3,4,5,6-tetrachloro-N-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3-dioxo-1H-inden-2-yl)-8-quinolyl]phthalimide",30125-47-4,"Oral:  Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening study, according to OECD 422, GLP, rat, NOAEL for general systemic toxicity: 1000 mg/kg bw/d (no mortality or signs of toxicity)   Inhalation: Short-term Inhalation Study, similar to OECD 412, GLP, rat, 5-day treatment with 21 days recovery, NOAEC for systemic effects: 60 mg/m³ air, NOAEC for local effects: 20 mg/m³ air Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Similar to OECD TG 412, GLP, Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Similar to OECD TG 412, GLP, Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): According to OECD TG 422, GLP, Klimisch 1 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cae69c8a-eb99-45fb-b9bb-0bf36f0ee76c/documents/IUC5-46119c3e-9805-4592-9917-ea16d02c8941_41847168-f69f-4fff-bf9c-f5ceb63472fa.html,,,,,, "3,4,5,6-tetrachloro-N-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3-dioxo-1H-inden-2-yl)-8-quinolyl]phthalimide",30125-47-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cae69c8a-eb99-45fb-b9bb-0bf36f0ee76c/documents/IUC5-46119c3e-9805-4592-9917-ea16d02c8941_41847168-f69f-4fff-bf9c-f5ceb63472fa.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,4,5,6-tetrachloro-N-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3-dioxo-1H-inden-2-yl)-8-quinolyl]phthalimide",30125-47-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cae69c8a-eb99-45fb-b9bb-0bf36f0ee76c/documents/IUC5-46119c3e-9805-4592-9917-ea16d02c8941_41847168-f69f-4fff-bf9c-f5ceb63472fa.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,60 mg/m3,,rat "3,4,5,6-tetrachloro-N-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3-dioxo-1H-inden-2-yl)-8-quinolyl]phthalimide",30125-47-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cae69c8a-eb99-45fb-b9bb-0bf36f0ee76c/documents/IUC5-46119c3e-9805-4592-9917-ea16d02c8941_41847168-f69f-4fff-bf9c-f5ceb63472fa.html,Repeated dose toxicity – local effects,inhalation,NOAEC,20 mg/m3,adverse effect observed,rat "3,4,5,6-tetrachloro-N-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3-dioxo-1H-inden-2-yl)-8-quinolyl]phthalimide",30125-47-4,"Suitable acute toxicity studies were only available for oral and dermal adminisration of the test substance. As the study regarding acute inhalation toxicity obtained methodological deficincies, read across on reliable data from an analogue substance was performed.   - Oral: similar to OECD guideline 401, prior GLP, LD50 (rat) >10000 mg/kg bw (no mortality or signs of toxicity) - Inhalation: read across to CAS 106276-80-6, similar to OECD guideline 403, prior GLP, LC50 (rat) >1.04 mg/L (no mortality or signs of toxicity) - Dermal: similar to OECD guideline 402, prior GLP, LD50 (rat) >2500 mg/kg bw (no mortality or signs of toxicity) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Similar to OECD TG 401, pre-GLP, Klimisch 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Read across to CAS 106276-80-6: similiar to OECD TG 403, pre-GLP, Klimisch 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): similiar to OECD TG 402, pre-GLP, Klimisch 2 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cae69c8a-eb99-45fb-b9bb-0bf36f0ee76c/documents/IUC5-7cb80beb-cec2-4015-ba36-f105ed52313b_41847168-f69f-4fff-bf9c-f5ceb63472fa.html,,,,,, "3,4,5,6-tetrachloro-N-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3-dioxo-1H-inden-2-yl)-8-quinolyl]phthalimide",30125-47-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cae69c8a-eb99-45fb-b9bb-0bf36f0ee76c/documents/IUC5-7cb80beb-cec2-4015-ba36-f105ed52313b_41847168-f69f-4fff-bf9c-f5ceb63472fa.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "3,4,5,6-tetrachloro-N-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3-dioxo-1H-inden-2-yl)-8-quinolyl]phthalimide",30125-47-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cae69c8a-eb99-45fb-b9bb-0bf36f0ee76c/documents/IUC5-7cb80beb-cec2-4015-ba36-f105ed52313b_41847168-f69f-4fff-bf9c-f5ceb63472fa.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "3,4,5,6-tetrachloro-N-[2-(4,5,6,7-tetrachloro-2,3-dihydro-1,3-dioxo-1H-inden-2-yl)-8-quinolyl]phthalimide",30125-47-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cae69c8a-eb99-45fb-b9bb-0bf36f0ee76c/documents/IUC5-7cb80beb-cec2-4015-ba36-f105ed52313b_41847168-f69f-4fff-bf9c-f5ceb63472fa.html,,inhalation,discriminating conc.,"1,041 mg/m3",no adverse effect observed, "3,4,5,6-tetrahydrophthalimide",4720-86-9, Supplier's data: LD50 rat: 1800 mg/kg LD50 mouse: 1525 mg/kg LD50 guinea pig: 1500 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25a0349b-b55e-486f-b33a-ad28f8bae4b7/documents/6dca0c3b-8a47-4ad5-9bab-451efa08d8c1_f60328aa-3628-4287-a9f7-39bac1ac103d.html,,,,,, "(2R,3R,4R,5S)-2-(hydroxymethyl)piperidine-3,4,5-triol",19130-96-2,"Oral (Rat-Wistar, GLP, Richtlinie 84/449/EWG, B. 1): LD50 > 5000 mg/kg[Bayer AG, Report No. 16299, 1987-12-14] ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9ae2288-0e5a-4b72-ad59-4ae11a9509f8/documents/IUC5-d43c9812-3aa3-4fbd-8685-5ac29cc96f2b_3f0fdf3a-302c-4497-8d3b-5471c0f60aaa.html,,,,,, "3,4,5-trifluorophenol",99627-05-1, The NOAEL after oral application was determined to be 450 mg/kg bw/day for males and females after 28 days administration to Wistar rats (reference 7.5.1 -1). ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00f16a18-c320-411d-b4f5-38853d804dab/documents/7b6e7c30-8df4-4fc2-8ba5-f55b5d89c814_b7420db9-8250-4b49-a64a-c3daa115136b.html,,,,,, "3,4,5-trifluorophenol",99627-05-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00f16a18-c320-411d-b4f5-38853d804dab/documents/7b6e7c30-8df4-4fc2-8ba5-f55b5d89c814_b7420db9-8250-4b49-a64a-c3daa115136b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat "3,4,5-trifluorophenol",99627-05-1," oral: A study according to OECD TG 423 was performed to determine the acute toxicity of the test item after oral administration to rats. The LD50 for males and females, after an observation period of 15 days, is expected to be between 200 - 2000 mg/kg bw (reference 7.2.1 -1). dermal Acute Toxicity Estimate (ATE): 1.100,1 mg/kg bw. The substance in corrosive to skin (please refer to section 7.3.1). inhalative Acute Toxicity Estimate (ATE): 1,6 mg/L (dust/mist). Symptoms: mucosal irritations, cough, shortness of breath, damage of respiratory tract ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00f16a18-c320-411d-b4f5-38853d804dab/documents/aacb3130-76b2-444c-a7fc-932d7893f6ea_b7420db9-8250-4b49-a64a-c3daa115136b.html,,,,,, "3,4-dichloroaniline",95-76-1,"acute toxicity, oral: Löser, E, 1981, study report, Bayer AG In this study 3,4-dichloroaniline was administered to groups of 10 male Wistar TNO W74 rats by oral gavage in doses of 0.3,0.5, 0.6, 0.7 or 0.8 g/kg body weight. Clinical signs of toxicity and mortality were documented. In the 0.3 g/kg bw group no toxixity was evident. All other groups showed increasing signs of toxicity including diarrhoea, chromodakryorrhoe, bloody snout, face down position, reduced spontaneous activity, narkosis, paralysis of hint extremities. Dead animals were found in those groups on the second or third day post-application. The calculated LD50 was 0.57 g/kg bw. According to this study 3,4-dichloroaniline should be classified as harmful if swallowed. Marty, J.P. and Wepierre, J., 1979 In this study the acute oral toxicity of 3,4-dichloroaniline in rats (Wistar) was determined by oral gavage of the test material solved in 1% carboxymethylcellulose. The calculated LD50 for rats were 880 mg / kg for males and 530 mg / kg for females. Observed signs of toxicity were agitation, difficult breathing and cyanosis. Marty, J.P. and Wepierre, J., (1979), Labo-Pharma Vol. 27- Problèmes et Techniques 286: 306-310 In this study the acute oral toxicity of 3,4-dichloroaniline in mice (NMRI) was determined by oral gavage of the test material solved in 1 % Carboxymethylcellulose. The calculated LD50 for mice were 510 mg / kg for males and 470 mg / kg for females. Observed signs of toxicity were agitation, difficult breathing and cyanosis.   acute toxicity, inhalation: Maertins, T, 1990 The inhalative acute exposure of rats according to OECD 403 with 324 or 631 mg 3,4-dichloroaniline / m³ for 4 h was not fatal for rats. Testing of higher concentrations was technical not possible. Only the high dose group showed signs of toxicity indicated by bradypnoe and reduced motility on the day of exposure but recovered thereafter.   acute toxicity, dermal: Löser, E., 1981 After acute dermal exposure of male Wistar rats to 1000 mg 3,4-dichloroaniline /kg bw no signs of toxicity were evident and no mortality was observed. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39823410-321c-442b-9dc8-c40849962201/documents/23d0fe29-f8a9-44b5-8ad0-bfb9bdf5135c_16b8375d-a785-4ea0-ad67-7c4c2b095c8d.html,,,,,, "3,4-dichloroaniline",95-76-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39823410-321c-442b-9dc8-c40849962201/documents/23d0fe29-f8a9-44b5-8ad0-bfb9bdf5135c_16b8375d-a785-4ea0-ad67-7c4c2b095c8d.html,,oral,LD50,570 mg/kg bw,, "3,4-dichloroaniline",95-76-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39823410-321c-442b-9dc8-c40849962201/documents/23d0fe29-f8a9-44b5-8ad0-bfb9bdf5135c_16b8375d-a785-4ea0-ad67-7c4c2b095c8d.html,,dermal,LD50,"> 1,000 mg/kg bw",, "3,4-dichloroaniline",95-76-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39823410-321c-442b-9dc8-c40849962201/documents/23d0fe29-f8a9-44b5-8ad0-bfb9bdf5135c_16b8375d-a785-4ea0-ad67-7c4c2b095c8d.html,,inhalation,LC50,> 0.631 mg/L,, "3,4-dichlorobenzonitrile",6574-99-8," Acute Oral Toxicity:In an acute oral toxicity study equivalent to OECD 423 the LD50 of 3,4 -Dichlorobenzonitrile was established to be within the range of 200 -2000 mg/kg body weight. Because of this 3,4 -Dichlorobenzonitrile is classified as harmful and requires the hazard statement H302 - ""Harmful if swallowed” according to Regulation(EC) No1272/2008. Acute Dermal Toxicity: In order to classify the substance 3,4 -Dichlorobenzonitrile (without any unneccessary animal testing) for this enpoint the testing results with 2-Chlorobenzonitrile and 2,6-Dichlorbenzonitrile are read acrossed to 3,4-Dichlorobenzonitrile. 2 -Chlorobenzonitrile was tested in a study equivalent to OECD Guideline 402 to be harmful in contact with skin and was classified as acute tox. 4 H312. This agrees with the official classification in acute dermal toxicity of 2,6 -Dichlorobenzonitrile. Therefore 3,4 -Dichlorobenzonitrile was classified as cute tox. 4 H312 (""Harmful in contact with skin""). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31fb560b-899c-43ae-b48e-281d650fa2eb/documents/IUC5-b8a6ad8c-e0af-48f0-83c5-fbfe67572e4d_ea193e55-fbf6-4437-9f7d-d92918ceb3d2.html,,,,,, "3,4-dichlorobenzonitrile",6574-99-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31fb560b-899c-43ae-b48e-281d650fa2eb/documents/IUC5-b8a6ad8c-e0af-48f0-83c5-fbfe67572e4d_ea193e55-fbf6-4437-9f7d-d92918ceb3d2.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "3,4-dichlorobenzonitrile",6574-99-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31fb560b-899c-43ae-b48e-281d650fa2eb/documents/IUC5-b8a6ad8c-e0af-48f0-83c5-fbfe67572e4d_ea193e55-fbf6-4437-9f7d-d92918ceb3d2.html,,dermal,LD50,350 mg/kg bw,adverse effect observed, "3,4-dichlorobut-1-ene",760-23-6,"-Acute Oral Toxicity (rat, OECD guideline 401); LD50: male=943 mg/kg; female=946 mg/kg;-Acute Inhalation Toxicity (rat, no guideline); LC50= 10.89 mg/L/4h;-Acute Dermal Toxicity (rabbit, OECD guideline 402); LD50>2000 mg/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e687a455-6db4-4fd8-8c6b-d5a400ccefbe/documents/IUC5-0e8d6c70-94bd-4418-ad67-a5ed57f60ae1_5b4cd6d9-d990-4633-be4d-743ecf226b51.html,,,,,, "3,4-dichlorophenyl isocyanate",102-36-3,"Acute toxicity via Oral route: Female rat LD50 = 91 mg/kg bw (Key, Rel.2). Acute toxicity via Inhalation route: LC50 = 0.338 mg/L (Key, Rel.2) Acute toxicity via Dermal route: Combined LD50 > 2000 mg/kg bw (Key, Rel2). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Three studies are available, all being pre-GLP and pre-guidelines. As a worst-case, the study giving the lowest LD50 value was selected as the key study. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Inconsistent results were also obtained from the acute inhalation toxicity studies. The results obtained by Pauluhn (1988) was considered to be the most reliable due to methological deficiences or non-linear dose depency noted on the other studies. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Two studies are available, both being pre-GLP and pre-guidelines. The study of Lamb (1975) was identified as the key study as it well-documented and scientifically acceptable. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4411eb9b-8cb4-430d-b6fc-a188dd92a040/documents/IUC5-49f71258-47bc-4dec-92a4-e42a8dfa84b4_70d1ab81-bfb3-4a16-8013-5cb3a7bca4e6.html,,,,,, "3,4-dichlorophenyl isocyanate",102-36-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4411eb9b-8cb4-430d-b6fc-a188dd92a040/documents/IUC5-49f71258-47bc-4dec-92a4-e42a8dfa84b4_70d1ab81-bfb3-4a16-8013-5cb3a7bca4e6.html,,oral,LD50,91 mg/kg bw,adverse effect observed, "3,4-dichlorophenyl isocyanate",102-36-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4411eb9b-8cb4-430d-b6fc-a188dd92a040/documents/IUC5-49f71258-47bc-4dec-92a4-e42a8dfa84b4_70d1ab81-bfb3-4a16-8013-5cb3a7bca4e6.html,,dermal,LD50,">=2,000 mg/kg bw",no adverse effect observed, "3,4-dichlorophenyl isocyanate",102-36-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4411eb9b-8cb4-430d-b6fc-a188dd92a040/documents/IUC5-49f71258-47bc-4dec-92a4-e42a8dfa84b4_70d1ab81-bfb3-4a16-8013-5cb3a7bca4e6.html,,inhalation,LC50,338 mg/m3,adverse effect observed, "3,4-dicyanoaniline",56765-79-8," Acute oral toxicity:  Acute oral toxicity dose (LD50) for 4-aminobenzene-1,2-dicarbonitrile (CAS no: 56765-79-8) was predicted based on OECD QSAR toolbox 167 mg/kg bw and different studies available on structurally similar read across substances 1,2-Dicyanobenzene (91-15-6) 85 mg/kg bw and 2-methyl-p-phenylenediamine (95-70-5) 102 mg/kg bw. All these studies concluded that the LD50 value is between 50-300 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 4-aminobenzene-1,2-dicarbonitrile can be classified as category 3 of acute oral toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80e9b775-027f-41fb-841c-a8eddcd3a58a/documents/8c9c12af-67e9-4408-a69d-3bb12ff2319c_2d5429d1-84db-443a-b4d1-139d2ea99d9c.html,,,,,, "3,4-dicyanoaniline",56765-79-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80e9b775-027f-41fb-841c-a8eddcd3a58a/documents/8c9c12af-67e9-4408-a69d-3bb12ff2319c_2d5429d1-84db-443a-b4d1-139d2ea99d9c.html,,oral,LD50,167 mg/kg bw,adverse effect observed, "3,4-dihydroxybenzonitrile",17345-61-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b9aaf0f-1f29-4994-ac6a-774463ee98ec/documents/c47129ab-e424-4f4a-a12f-c328896875f0_1d8ca71f-8e22-42a0-8e09-19220169d958.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "3,4-dihydroxybenzonitrile",17345-61-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b9aaf0f-1f29-4994-ac6a-774463ee98ec/documents/89b75808-8df0-46f8-9dac-0d105b8a1d49_1d8ca71f-8e22-42a0-8e09-19220169d958.html,,oral,LD50,200 mg/kg bw,adverse effect observed, "3,4-dimethoxyphenethylamine",120-20-7, - oral LD50 in rat = 720.0 mg/kg - inhalatory LC50 in rat > 5.5 mg/l; no mortality occured - dermal LD50 in rabbit = 2800 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d97a111e-1367-4546-a85d-75167e57d920/documents/c832a71a-749f-436a-a7c9-304a5496b8bb_f4273583-2e3d-460e-affd-4768d92f3e79.html,,,,,, "3,4-dimethoxyphenethylamine",120-20-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d97a111e-1367-4546-a85d-75167e57d920/documents/c832a71a-749f-436a-a7c9-304a5496b8bb_f4273583-2e3d-460e-affd-4768d92f3e79.html,,oral,LD50,720 mg/kg bw,adverse effect observed, "3,4-dimethoxyphenethylamine",120-20-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d97a111e-1367-4546-a85d-75167e57d920/documents/c832a71a-749f-436a-a7c9-304a5496b8bb_f4273583-2e3d-460e-affd-4768d92f3e79.html,,dermal,LD50,"2,800 mg/kg bw",no adverse effect observed, "3,4-dimethoxyphenethylamine",120-20-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d97a111e-1367-4546-a85d-75167e57d920/documents/c832a71a-749f-436a-a7c9-304a5496b8bb_f4273583-2e3d-460e-affd-4768d92f3e79.html,,inhalation,discriminating conc.,"5,500 mg/m3",no adverse effect observed, "3,4-dimethylbenzaldehyde",5973-71-7,"A NOEL of 50 mg/kg bw/day for females and of 250 mg/kg bw/day for males was established in a combined repeat dose toxicity study with reproduction/developmental toxicity screening test in rats (OECD 422, GLP). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df4aa096-cd23-42d6-8f11-a944b843465b/documents/IUC5-1e19c0a3-3c52-4e71-a14a-959385984fe8_df1e4253-cd64-4912-bef6-f24c3b75b1fe.html,,,,,, "3,4-dimethylbenzaldehyde",5973-71-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df4aa096-cd23-42d6-8f11-a944b843465b/documents/IUC5-1e19c0a3-3c52-4e71-a14a-959385984fe8_df1e4253-cd64-4912-bef6-f24c3b75b1fe.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "3,4-dimethylbenzaldehyde",5973-71-7,"The acute oral LD50 of the test material in the female Sprague-Dawley rat was >2000 mg/kg body weight (OECD 423, GLP). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df4aa096-cd23-42d6-8f11-a944b843465b/documents/IUC5-e942fc84-71f8-4b19-9b29-318cd16b6374_df1e4253-cd64-4912-bef6-f24c3b75b1fe.html,,,,,, "3,5,5-trimethylcyclohex-3-en-1-one",471-01-2,"In subchronic studies, oral administration of high doses of isophorone (NOAEL (male rat, 90 days) = 102.5 mg/kg bw/day, NOAEL (female rat, 13 weeks) 500 mg/kg bw/day; NOAEL (male mouse, 16 days) = 500 mg/kg bw/day, NOAEL (female mouse, 16 days) = 125 mg/kg bw/day; NOAEL (dog, 90 days) ≥ 150 mg/kg bw/day) caused no significant toxic effects (all NOAELs are based on slight (<14%) reductions in body weight gain). After inhalational administration nose and eye irritation and blood and liver changes were observed (NOAEL (rat, 28 days) < 208 mg/m3). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eaa9c402-ca9e-44bd-bc84-4ec1835e6d5e/documents/IUC5-44906545-df51-4823-bbc3-1d05ae50dd38_ed419aa0-3c0e-489a-862c-1e3deab64cff.html,,,,,, "3,5,5-trimethylcyclohex-3-en-1-one",471-01-2,The acute toxicity in laboratory animals is low to moderate (oral LD50 ≥ 1500 mg/kg bw; dermal LD50 ≥ 1200 mg/kg bw; inhalative LC50 = 7000 mg/m3). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eaa9c402-ca9e-44bd-bc84-4ec1835e6d5e/documents/IUC5-5de7ab99-516f-4191-bdb7-d1a8cf053dd2_ed419aa0-3c0e-489a-862c-1e3deab64cff.html,,,,,, "3,5,5-trimethylhexanoic acid",3302-10-1,"A reliable repeated dose (28 day) oral study in rats reports an NOAEL of 50 mg/kg bw/d and a LOAEL of 200 mg/kg bw/d for decreased motor activity, liver effects, alterations in clinical chemistry and urinalysis parameters. In a 90 d oral toxicity study (OECD 408), peroxisomal proliferation was detected in high-dose males and females and mid-dose females and alpha-2u in mid and high dose males; no effects have been noted at the lowest dose; therefore, the NOAEL of this study was set at 5 mg/kg/d ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a502951-5917-4008-84fd-e523ab424b4f/documents/4289c5b7-00da-44cb-a6a4-476c93973503_9c4644f6-0fec-489c-9350-6580d0d8f22c.html,,,,,, "3,5,5-trimethylhexanoic acid",3302-10-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a502951-5917-4008-84fd-e523ab424b4f/documents/4289c5b7-00da-44cb-a6a4-476c93973503_9c4644f6-0fec-489c-9350-6580d0d8f22c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat "3,5,5-trimethylhexanoic acid",3302-10-1,"Oral LD50 values of reliable rat studies lie within the range of 1160-3135 mg/kg bw, and a fixed dose rat study reports mortality and other toxic effects at 2000 mg/kg bw. In a reliable inhalation study no mortality was observed in rats exposed to saturated vapour (ca. 0.03 mg/L). No reliable data for the test substance are availbale for the dermal route.   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a502951-5917-4008-84fd-e523ab424b4f/documents/ec08d7f2-4d62-4f60-85f8-d2c48a661b9f_9c4644f6-0fec-489c-9350-6580d0d8f22c.html,,,,,, "3,5,5-trimethylhexanoic acid",3302-10-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a502951-5917-4008-84fd-e523ab424b4f/documents/ec08d7f2-4d62-4f60-85f8-d2c48a661b9f_9c4644f6-0fec-489c-9350-6580d0d8f22c.html,,oral,LD50,"1,160 mg/kg bw",adverse effect observed, "3,5-di(undecan-2-yl)dihydro-1H-[1,3]oxazolo[3,4-c][1,3]oxazole",1001161-63-2, REACH_NOAEL = 1000 mg/kg bw/d | rat (male/female) | OECD 407 | #key study# ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48c992a6-f1f1-4e8f-a355-dfe64d372f3a/documents/275f2df2-5cda-4a76-b9a5-ba558d4f3bde_0b69076b-f5ea-4274-b885-a68f65805964.html,,,,,, "3,5-di(undecan-2-yl)dihydro-1H-[1,3]oxazolo[3,4-c][1,3]oxazole",1001161-63-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48c992a6-f1f1-4e8f-a355-dfe64d372f3a/documents/275f2df2-5cda-4a76-b9a5-ba558d4f3bde_0b69076b-f5ea-4274-b885-a68f65805964.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,5-di(undecan-2-yl)dihydro-1H-[1,3]oxazolo[3,4-c][1,3]oxazole",1001161-63-2, REACH_LD50 >2000 mg/kg | rat (male/female) | OECD 423 | #key study# ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48c992a6-f1f1-4e8f-a355-dfe64d372f3a/documents/d3efba7b-517f-49d9-8f55-51d2caf349db_0b69076b-f5ea-4274-b885-a68f65805964.html,,,,,, "3,5-di(undecan-2-yl)dihydro-1H-[1,3]oxazolo[3,4-c][1,3]oxazole",1001161-63-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48c992a6-f1f1-4e8f-a355-dfe64d372f3a/documents/d3efba7b-517f-49d9-8f55-51d2caf349db_0b69076b-f5ea-4274-b885-a68f65805964.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,5-diaminobenzoic acid",535-87-5, LD50 value was estimated to be 2844 mg/kg bw for rats for 24 duration. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f00b8806-ced0-4a3b-811b-12df389f8c2f/documents/5b43c2c1-b019-4ff5-86cd-b0bc8b670006_d639248f-2d6d-4699-bbab-106485f88da9.html,,,,,, "3,5-diaminobenzoic acid",535-87-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f00b8806-ced0-4a3b-811b-12df389f8c2f/documents/5b43c2c1-b019-4ff5-86cd-b0bc8b670006_d639248f-2d6d-4699-bbab-106485f88da9.html,,oral,LD50,"2,844 mg/kg bw",no adverse effect observed, "3,5-dichlorobenzoyl chloride",2905-62-6,"OralLD50 794 mg/kg bw, similar to OECD 401, rat, Powers (1969) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ddaada6-6d45-42ef-bb93-6dc67bca225e/documents/08efdc49-9c23-4570-b746-95473cb5d1c5_49c3a238-ee58-4e9e-9a81-b4cc2b61eab6.html,,,,,, "3,5-dichlorobenzoyl chloride",2905-62-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ddaada6-6d45-42ef-bb93-6dc67bca225e/documents/08efdc49-9c23-4570-b746-95473cb5d1c5_49c3a238-ee58-4e9e-9a81-b4cc2b61eab6.html,,oral,LD50,794 mg/kg bw,adverse effect observed, "3,5-dihydroxy-2,6,6-tris(3-methylbuten-2-yl)-4-(3-methyl-1-oxobutyl)cyclohexa-2,4-dien-1-one",468-28-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85986021-af00-4289-b660-c5419dbac015/documents/fc6eef9f-27e5-47d6-97ee-56414e075329_a749538b-405c-4ab3-baf2-542c2e693792.html,,oral,LD50,700 mg/kg bw,adverse effect observed, "3,5-dihydroxy-2,6,6-tris(3-methylbuten-2-yl)-4-(3-methyl-1-oxobutyl)cyclohexa-2,4-dien-1-one",468-28-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85986021-af00-4289-b660-c5419dbac015/documents/fc6eef9f-27e5-47d6-97ee-56414e075329_a749538b-405c-4ab3-baf2-542c2e693792.html,,dermal,LD50,700 mg/kg bw,, "3,5-diiodothyronine",1041-01-6, A study on acute oral toxicity according to OECD 423 was conducted. The LD50 was found to be > 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1eccdb80-4d03-43de-9e4a-ecbed220c3b5/documents/98e61cd1-9eee-46ba-93a2-24df7dc7e19d_bf6314c7-39af-4e8e-9dc7-80979d2e1341.html,,,,,, "3,5-diiodothyronine",1041-01-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1eccdb80-4d03-43de-9e4a-ecbed220c3b5/documents/98e61cd1-9eee-46ba-93a2-24df7dc7e19d_bf6314c7-39af-4e8e-9dc7-80979d2e1341.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,5-dimethyl-1,2-dioxolane-3,5-diol",13784-51-5," The substance was administered daily by oral gavage to Wistar rats of both sexes at at 100, 300 and 1000 mg/kg body weight/day for 28 days (5 animals / group), and a control group (vehicle, double distilled water). Test item-related non-adverse findings noted at 1000 mg/kg/day were restricted to slightly diminished fore limb grip strength in males only, reduced locomotor activity, reduced food consumption, and body weight development in males and females. Non-adverse findings noted in hematology parameters at 1000 mg/kg/day included compensatory reticulocytosis, whereas females also showed mild anemia. Mild reticulocytosis was also noted in females at 300 mg/kg/day. These findings are generally recognized as reversible after exposure is discontinued. Males and females at 1000 mg/kg/day showed mild aberrations in lipid metabolism that were attributed to metabolic adaptation (therefore non-adverse). Increased organ weights included relative liver weights (considered to be an adaptive change and not adverse) and relative kidney weights in males and females and relative spleen weights in males only at 1000 mg/kg/day. Test item-related non-adverse and typically adaptive microscopic findings included hypertrophy of mucosal epithelium of duodenum, centrilobular hepatocellular hypertrophy and increased incidence and severity of extramedullary erythrocytic hemopoiesis (i.e. erythropoiesis) in both sexes treated with 1000 mg/kg/day, increased erythropoiesis in femur bone marrow in females treated with 1000 mg/kg/day, and enhanced hyaline droplets in renal proximal tubules as well as increased incidence and severity of tubular basophilia in the kidney in males treated with 300 and 1000 mg/kg/day. A (NOEL) of 100 mg/kg body weight/day and NOAEL of 300 mg/kg body weight/day were reported in the above study. However, based on human relevance and typical adaptive nature of some of the effects, a NOAEL of 1000 mg/kg bw/d was established as the correct NOAEL.     The substance was administered orally, by gavage, to Han Wistar rats for 13 weeks. Three groups, each comprising ten males and ten females, received the test item at doses of 80, 250 or 750 mg/kg/day and a similarly constituted control group received the vehicle (purified water) at the same dose volume. The appearance and behavior of the animals were unaffected by treatment, there were no treatment-related findings at the sensory activity, grip strength and motor activity assessment in Week 12 and no deaths occurred during the treatment period. Overall body weight gain was reduced by approximately 15% in males receiving 750 mg/kg/day but there was no effect on their food consumption. Females were unaffected. There were no treatment-related ophthalmoscopic findings. The hematological examination in Week 13 indicated high reticulocyte count in animals receiving 750 mg/kg/day which associated with increased red cell distribution width in males and an increased mean cell hemoglobin in females but all other erythrocyte indices were unaffected. Males and females receiving 750 mg/kg/day had high neutrophil, lymphocyte, monocyte and large unstained cell counts, with males also showing increased eosinophil count and females showing increased basophil count, and there was also an increase of lymphocyte and basophil count in females receiving 250 mg/kg/day. As a consequence, total leucocyte counts were higher than controls in females receiving 250 mg/kg/day and in males and females receiving 750 mg/kg/day. Treatment-related changes in the blood plasma in Week 13 comprised: high bile acid concentration in animals receiving 750 mg/kg/day; high urea/blood urea nitrogen concentrations in males receiving 250 mg/kg/day and in animals receiving 750 mg/kg/day; low creatinine concentration in females receiving 250 mg/kg/day and in males and females receiving 750 mg/kg/day; high glucose concentrations in animals receiving 750 mg/kg/day; increased high and low density lipoprotein concentrations with an associated increase of total cholesterol concentration in males and females receiving 750 mg/kg/day and which associated with high triglyceride concentrations in females; low calcium concentrations in animals receiving 750 mg/kg/day; high phosphorus concentrations in males receiving 750 mg/kg/day; low sodium and chloride concentrations in females receiving 750 mg/kg/day. Urinary pH was slightly low in Week 13 in males and females receiving 750 mg/kg/day.   Acetylacetone Peroxide had no effect on estrus cycle or on spermmotility, morphology and sperm count in the testis and cauda epididymis.   Serum triiodothyronine (T3), thyroxine (T4) and thyroid stimulation hormone (TSH) concentrations were unaffected by treatment.   After 13 weeks of treatment kidney weights were high in females given 250 mg/kg/day and in males and females given 750 mg/kg/day, liver weights were high in males and females given 750 mg/kg/day and, in addition, males given 750 mg/kg/day had high spleen and low combined prostate/seminal vesicle/coagulating gland weight.   Pale kidneys were reported at the macroscopic examination in two males given 250 mg/kg/day and in eight males given 750 mg/kg/day.   Treatment-related histopathological findings were confined to the kidneys of males where tubular hyaline droplet accumulation was observed in four males given 80 mg/kg/day and all males given 250 or 750 mg/kg/day which, in some of the high dose males, was accompanied by an adverse finding of tubular granular cast or tubular basophilia.   It is concluded that oral administration of Acetylacetone Peroxide to Han Wistar rats for 13 weeks at doses up to 750 mg/kg/day was well‑tolerated. At the highest dose, there was low overall body weight gain (15%) and hyaline droplet accumulation with nephropathy (granular cast and basophilic tubules) in males that were considered adverse. Consequently, the no‑observed-adverse-effect level (NOAEL) in this study was considered to be 250 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11ba2606-3e87-4cc9-985b-7bd7a1000434/documents/IUC5-cee7cc1c-1882-4701-9b6b-edb9dd4b8bba_64815cc3-fceb-40b1-87ac-17e173f8352e.html,,,,,, "3,5-dimethyl-1,2-dioxolane-3,5-diol",13784-51-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11ba2606-3e87-4cc9-985b-7bd7a1000434/documents/IUC5-cee7cc1c-1882-4701-9b6b-edb9dd4b8bba_64815cc3-fceb-40b1-87ac-17e173f8352e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "3,5-dimethyl-1,2-dioxolane-3,5-diol",13784-51-5," The LD50 of the test substance was higher than or equal to 2000 mg/kg by dermal or oral exposure. Fully described under ""Discussion"". ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11ba2606-3e87-4cc9-985b-7bd7a1000434/documents/IUC5-4e1a52d2-9417-4b1a-94a6-246ea3dc46ef_64815cc3-fceb-40b1-87ac-17e173f8352e.html,,,,,, "3,5-dimethyl-1,2-dioxolane-3,5-diol",13784-51-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11ba2606-3e87-4cc9-985b-7bd7a1000434/documents/IUC5-4e1a52d2-9417-4b1a-94a6-246ea3dc46ef_64815cc3-fceb-40b1-87ac-17e173f8352e.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3,5-dimethyl-1,2-dioxolane-3,5-diol",13784-51-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11ba2606-3e87-4cc9-985b-7bd7a1000434/documents/IUC5-4e1a52d2-9417-4b1a-94a6-246ea3dc46ef_64815cc3-fceb-40b1-87ac-17e173f8352e.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3,5-dimethyl-1,2-dioxolane-3,5-diol",13784-51-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11ba2606-3e87-4cc9-985b-7bd7a1000434/documents/IUC5-4e1a52d2-9417-4b1a-94a6-246ea3dc46ef_64815cc3-fceb-40b1-87ac-17e173f8352e.html,,inhalation,discriminating conc.,13.1 mg/m3,no adverse effect observed, "3,5-dimethylhex-1-yn-3-ol",107-54-0,"The test article is of low acute toxicity, the oral LD50 > 300 mg/kg bw, the dermal LD50 is > 1000 mg/kg bw and the 4 hour aerosol inhalation LC50 is > 4.9 mg/l. This equals an one hour exposure of 19700 mg/m³ aerosol. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff26c8b3-7ccb-4213-9cfe-bcba81e11b29/documents/IUC5-eaaca94d-ded4-4ac1-ac7c-88db08e0f5f0_d2322aa3-1d24-44b1-a995-238b18470ffd.html,,,,,, "3,5-dimethylhex-1-yn-3-ol",107-54-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff26c8b3-7ccb-4213-9cfe-bcba81e11b29/documents/IUC5-eaaca94d-ded4-4ac1-ac7c-88db08e0f5f0_d2322aa3-1d24-44b1-a995-238b18470ffd.html,,oral,LD50,300 mg/kg bw,no adverse effect observed, "3,5-dimethylhex-1-yn-3-ol",107-54-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff26c8b3-7ccb-4213-9cfe-bcba81e11b29/documents/IUC5-eaaca94d-ded4-4ac1-ac7c-88db08e0f5f0_d2322aa3-1d24-44b1-a995-238b18470ffd.html,,dermal,LD50,"1,000 mg/kg bw",no adverse effect observed, "3,5-dimethylhex-1-yn-3-ol",107-54-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff26c8b3-7ccb-4213-9cfe-bcba81e11b29/documents/IUC5-eaaca94d-ded4-4ac1-ac7c-88db08e0f5f0_d2322aa3-1d24-44b1-a995-238b18470ffd.html,,inhalation,LC50,"19,700 mg/m3",no adverse effect observed, "3,5-dimethylpyrazole",67-51-6," ORAL Key 28 day study; Zmarowski (2012), performed to GLP, OECD 422 and EPA OPPT 870.3650, Klimisch 1, NOAEL = 20 mg/kg b.w./ day in the rat. target organ is the liver. INHALATION A data waiver has been provided to cover this endpoint. DERMAL A data waiver has been provided to cover this endpoint. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dfda6556-f05a-4388-9cae-cbe95c0b69c0/documents/IUC5-e9224646-f774-4931-bd06-5f41f8245338_f7eefc35-7460-465e-8732-261fabd41a59.html,,,,,, "3,5-dimethylpyrazole",67-51-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dfda6556-f05a-4388-9cae-cbe95c0b69c0/documents/IUC5-e9224646-f774-4931-bd06-5f41f8245338_f7eefc35-7460-465e-8732-261fabd41a59.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "3,5-dimethylpyrazole",67-51-6," ORAL Key study; Parcell (1994a), performed to GLP, OECD 401 and EU B.1, Klimisch 1, LD50 = 1717 mg/kg bw. in rats. Supporting studies; Wallace (1976a), performed to sound scientific principles, Klimisch 2, LD50 > 2140 (1530 – 3000) mg/kg b.w. in rats. Dewitt (1953), data presented as an abstract with no recorded methodology, Klimisch 4, minimum lethal dose > 500 mg/kg bw. in rats. Material safety data sheets have been provided from Alfa Aesar (2007), Sigma Aldrich (2009) and Fischer Scientifics (2008), as there is no record of study protocol they have been assigned a Klimisch score of either 3 or 4. INHALATION A data waiver has been provided to cover this endpoint. DERMAL Key study; Hutchinson (2002a), performed to GLP, OECD 402, EU Method B.3 and EPA OPPTS 870.1200, Klimisch 1, LD50 > 2000 mg/kg b.w. in rats. OTHER ROUTES Supporting study; Vetulani (1996), non-GLP compliant study performed to a non-standard protocol, Klimisch 3, LD50 of 570 mg/kg bw when administered via intraperitoneal injection in mice. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfda6556-f05a-4388-9cae-cbe95c0b69c0/documents/IUC5-20b277e4-e719-4b43-81be-0fbf2af4c9b0_f7eefc35-7460-465e-8732-261fabd41a59.html,,,,,, "3,5-dimethylpyrazole",67-51-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfda6556-f05a-4388-9cae-cbe95c0b69c0/documents/IUC5-20b277e4-e719-4b43-81be-0fbf2af4c9b0_f7eefc35-7460-465e-8732-261fabd41a59.html,,oral,LD50,"1,717 mg/kg bw",adverse effect observed, "3,5-dimethylpyridine",591-22-0,"The substance shows acute toxicity by the oral, inhalation and dermal routes of exposure in experimental in vivo studies. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c785ec5b-4b4e-4788-aefb-2f9c203b9c4f/documents/IUC5-1edccb41-6195-4395-a572-583d1fa15c17_88e9b594-afd7-4436-95be-78fc97ace5ff.html,,,,,, "3,5-dimethylpyridine",591-22-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c785ec5b-4b4e-4788-aefb-2f9c203b9c4f/documents/IUC5-1edccb41-6195-4395-a572-583d1fa15c17_88e9b594-afd7-4436-95be-78fc97ace5ff.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "3,5-dimethylpyridine",591-22-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c785ec5b-4b4e-4788-aefb-2f9c203b9c4f/documents/IUC5-1edccb41-6195-4395-a572-583d1fa15c17_88e9b594-afd7-4436-95be-78fc97ace5ff.html,,dermal,LD50,"1,001 mg/kg bw",adverse effect observed, "3,5-dimethylpyridine",591-22-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c785ec5b-4b4e-4788-aefb-2f9c203b9c4f/documents/IUC5-1edccb41-6195-4395-a572-583d1fa15c17_88e9b594-afd7-4436-95be-78fc97ace5ff.html,,inhalation,LC50,"2,900 mg/m3",adverse effect observed, "3,5-xylidine",108-69-0,"OECD 407, GLP, rats,: NOEL 10 mg/kg/day for males and females. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline study ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7f99be5-ab8d-4cd0-91e4-23f58dfd8fa0/documents/9f36f6cd-19d7-481e-a4fa-d2e8b06aecf8_55dd9824-dc07-452f-8b57-ede16d2a64e5.html,,,,,, "3,5-xylidine",108-69-0,"Oral standard acute method, rats: LD50 710 mg/kg Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): data collection of sufficient quality ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7f99be5-ab8d-4cd0-91e4-23f58dfd8fa0/documents/32f3ed68-5b00-49b3-b20e-8deb274be9a1_55dd9824-dc07-452f-8b57-ede16d2a64e5.html,,,,,, "3,5-xylidine",108-69-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7f99be5-ab8d-4cd0-91e4-23f58dfd8fa0/documents/32f3ed68-5b00-49b3-b20e-8deb274be9a1_55dd9824-dc07-452f-8b57-ede16d2a64e5.html,,oral,LD50,710 mg/kg bw,adverse effect observed, "3,6,9,12-tetraoxahexadecan-1-ol",1559-34-8, Oral LD50 data in rats: 2630 mg/kgbw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae96106b-70f7-44c1-8c74-d00ba75863e3/documents/69a61786-d9b1-4992-aee1-3450d301bf98_52b75ed4-48e4-4e3e-8367-d82d4c413c46.html,,,,,, "3,6,9,12-tetraoxahexadecan-1-ol",1559-34-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae96106b-70f7-44c1-8c74-d00ba75863e3/documents/69a61786-d9b1-4992-aee1-3450d301bf98_52b75ed4-48e4-4e3e-8367-d82d4c413c46.html,,oral,LD50,"2,630 mg/kg bw",, 2-[2-(2-Ethenoxyethoxy)ethoxy]ethoxyethene,765-12-8,NOAEL for subacute toxicity: 735 mg/kg bw/dNOAEL for subchronic toxicity: 300 mg/kg bw/d ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6412d35a-0228-4390-ab4c-c63cc87e829f/documents/IUC5-9d64ef54-609b-4459-8e11-40700dc7dbf2_8dc9eb18-24b2-4d7b-878e-075bde43ed92.html,,,,,, 2-[2-(2-Ethenoxyethoxy)ethoxy]ethoxyethene,765-12-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6412d35a-0228-4390-ab4c-c63cc87e829f/documents/IUC5-9d64ef54-609b-4459-8e11-40700dc7dbf2_8dc9eb18-24b2-4d7b-878e-075bde43ed92.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat 2-[2-(2-Ethenoxyethoxy)ethoxy]ethoxyethene,765-12-8,Acute oral toxicity: LD50: > 2000 mg/kg bwAcute dermal toxicity: LD50: > 4000 mg/kg bwAcute inhalative toxicity: no data ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6412d35a-0228-4390-ab4c-c63cc87e829f/documents/IUC5-7c2cea4f-4d00-4954-ba92-442a61fe30b3_8dc9eb18-24b2-4d7b-878e-075bde43ed92.html,,,,,, "3,6,9,12-tetraoxotridecanol",23783-42-8," ORAL - RATS (mg/kg) TetraEGME LD50: 15000 mg/kg; LD0 5000mg/kg Supporting information: TEGME: LD50: >10500, 11.3ml/kg Mix of tri, tetra and penta methyls: >5000mg/kg, 10760-13450 mg/kg.  LD0: 5ml/kg, 5g/kg DERMAL LD50 (mg/kg) TEGME: Rabbit: 7100mg/kg Rat: Mix of tri, tetra and penta methyls: Rat LD0: >2000mg/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28cd3455-6162-4822-89c2-49b12763755f/documents/b50d4efd-c0b8-4bbd-960c-e58759b03822_3118a44e-629f-43bc-837d-74f6ff2de181.html,,,,,, "3,6,9,12-tetraoxotridecanol",23783-42-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28cd3455-6162-4822-89c2-49b12763755f/documents/b50d4efd-c0b8-4bbd-960c-e58759b03822_3118a44e-629f-43bc-837d-74f6ff2de181.html,,oral,LD50,"10,500 mg/kg bw",, "3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)",18268-70-7," There is no repeated dose toxicity information available for the test substance. The structurally related material, ethane-1,2-diylbis(oxyethane-2,1-diyl) bis(2-ethylhexanoate)(CAS No. 94 -28 -2) was adiminstered by gavage to male and female Wistar rats for at least 28 days at dose levels in the diet 1500, 5000 and 15000 ppm. These treatments revealed parental toxicity at 15000 ppm. Based on these results, a parental No Observed Adverse Effect Level (NOAEL) of 5000 ppm was derived. When corrected for mean test article intakethe NOAEL of 5000 ppm corresponds to 314-576 mg/kg body weight/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2214f43-ae6d-488d-bc98-1357e8882324/documents/d092f666-a021-458f-aa34-73c3645fef7d_2631cf0f-30c3-4c64-b0e2-ede5e4a9c56e.html,,,,,, "3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)",18268-70-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2214f43-ae6d-488d-bc98-1357e8882324/documents/d092f666-a021-458f-aa34-73c3645fef7d_2631cf0f-30c3-4c64-b0e2-ede5e4a9c56e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,314 mg/kg bw/day,,rat "3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)",18268-70-7," In an acute oral toxicity study in male and female Sprague-Dawley rats, no deaths were noted and only minimal clinical changes were observed during the observation period. These clinical changes generally resolved by 3 to 5 days of observation. There were no adverse necropsy findings. The acute oral LD 50 value was found to be greater than 5.0 g/kg. In an acute dermal toxicity study in male and female New Zealand White rabbits, no deaths were noted during the observation period. There were no necrospsy findings. The acute dermal LD 50 value was found to be greater than 20 g/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2214f43-ae6d-488d-bc98-1357e8882324/documents/3cb2c101-9508-4dad-8f77-bd301f1f3ea9_2631cf0f-30c3-4c64-b0e2-ede5e4a9c56e.html,,,,,, "3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)",18268-70-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2214f43-ae6d-488d-bc98-1357e8882324/documents/3cb2c101-9508-4dad-8f77-bd301f1f3ea9_2631cf0f-30c3-4c64-b0e2-ede5e4a9c56e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,6,9-trioxaundecamethylene bis(2-ethylhexanoate)",18268-70-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2214f43-ae6d-488d-bc98-1357e8882324/documents/3cb2c101-9508-4dad-8f77-bd301f1f3ea9_2631cf0f-30c3-4c64-b0e2-ede5e4a9c56e.html,,dermal,LD50,"20,000 mg/kg bw",no adverse effect observed, "3,6,9-trioxaundecamethylene dimethacrylate",109-17-1," Limited data are available to evaluate the acute toxicity of PEG-4 dimethacrylate. Based on these data, the oral LD50 value in the rat was >5000 mg/kg, and the dermal LD50 value in rat was > 3000 mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67111542-f283-4883-9d8e-c92ecbeecf0d/documents/85fa6b7d-8c90-4889-887a-ae477ab508ca_73061ecd-ffbc-44b6-8893-27759112305c.html,,,,,, "3,6,9-trioxaundecamethylene dimethacrylate",109-17-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67111542-f283-4883-9d8e-c92ecbeecf0d/documents/85fa6b7d-8c90-4889-887a-ae477ab508ca_73061ecd-ffbc-44b6-8893-27759112305c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,6,9-trioxaundecamethylene dimethacrylate",109-17-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67111542-f283-4883-9d8e-c92ecbeecf0d/documents/85fa6b7d-8c90-4889-887a-ae477ab508ca_73061ecd-ffbc-44b6-8893-27759112305c.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, "3,6,9-trioxaundecane-1,11-diol",112-60-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Very good. Rats were dermally dosed with tetraethylene glycol for 13 weeks to approximately 3360 mg/kg/day with no evidence of systemic toxicity. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Good. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): Very good. Rats were dermally dosed with tetraethylene glycol for 13 weeks to approximately 3360 mg/kg/day with no evidence of local effects. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Very good. A 28 day drinking water study was conducted with no evidence of systemic effects. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c0abf16-3bad-48ef-80ef-372fd411ccef/documents/IUC5-f95b620b-3ac9-462a-b79c-dce540762db8_ac0eb5a3-3229-4a8c-bd2a-6b1b7cda10f3.html,,,,,, "3,6,9-trioxaundecane-1,11-diol",112-60-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c0abf16-3bad-48ef-80ef-372fd411ccef/documents/IUC5-f95b620b-3ac9-462a-b79c-dce540762db8_ac0eb5a3-3229-4a8c-bd2a-6b1b7cda10f3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"2,000 mg/kg bw/day",,rat "3,6,9-trioxaundecane-1,11-diol",112-60-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c0abf16-3bad-48ef-80ef-372fd411ccef/documents/IUC5-f95b620b-3ac9-462a-b79c-dce540762db8_ac0eb5a3-3229-4a8c-bd2a-6b1b7cda10f3.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,036 mg/m3",,rat "3,6,9-trioxaundecane-1,11-diol",112-60-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c0abf16-3bad-48ef-80ef-372fd411ccef/documents/IUC5-f95b620b-3ac9-462a-b79c-dce540762db8_ac0eb5a3-3229-4a8c-bd2a-6b1b7cda10f3.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"3,360 mg/kg bw/day",,rat "3,6,9-trioxaundecane-1,11-diol",112-60-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Although the database is quite old, the results demonstrate that lethality is observed only at very high doses. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): A saturated vapor is quite low, 0.061 ppm (0.49 ug/L) with no mortality noted. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Although the database is old, the results demonstrate that lethality is observed only at very high doses. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c0abf16-3bad-48ef-80ef-372fd411ccef/documents/IUC5-bfb08401-e893-42cb-8940-d611ae391b74_ac0eb5a3-3229-4a8c-bd2a-6b1b7cda10f3.html,,,,,, "3,6,9-trioxaundecane-1,11-diol",112-60-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c0abf16-3bad-48ef-80ef-372fd411ccef/documents/IUC5-bfb08401-e893-42cb-8940-d611ae391b74_ac0eb5a3-3229-4a8c-bd2a-6b1b7cda10f3.html,,oral,LD50,"30,000 mg/kg bw",no adverse effect observed, "3,6,9-trioxaundecane-1,11-diol",112-60-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c0abf16-3bad-48ef-80ef-372fd411ccef/documents/IUC5-bfb08401-e893-42cb-8940-d611ae391b74_ac0eb5a3-3229-4a8c-bd2a-6b1b7cda10f3.html,,dermal,LD50,"22,600 mg/kg bw",no adverse effect observed, "3,6-bis(diethylamino)-9-[2-(ethoxycarbonyl)phenyl]xanthylium chloride",2390-63-8," Acute oral toxicity: Under the conditions of the study, the oral LD50 value of the test material in Wistar rats was established to be within the range of 50 to 300 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27e391c7-d532-4fdc-b3d9-a14b8bd5fe05/documents/43e3d07e-2efe-4b57-8717-7531535b73f7_8520dfdb-aff5-49c3-b8e1-c8242ef7c094.html,,,,,, "3,6-bis(diethylamino)-9-[2-(ethoxycarbonyl)phenyl]xanthylium chloride",2390-63-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27e391c7-d532-4fdc-b3d9-a14b8bd5fe05/documents/43e3d07e-2efe-4b57-8717-7531535b73f7_8520dfdb-aff5-49c3-b8e1-c8242ef7c094.html,,oral,LD50,50 mg/kg bw,adverse effect observed, "3,6-dioxaoctamethylenediamine",929-59-9," Both studies were performed in 1985. The reliability of these reports is Klimisch 1 as these studies were performed under GLP. The calculated acute oral LD50 for male and female rats was determined to be 1569 mg/kg with 95% confidence limits of 1243 to 1980 mg/kg The calculated acute oral LD50 in males was determined to be 1960 mg/kg with 95% confidence limits of 1376 to 2792 mg/kg. The calculated acute oral LD50 in females was determined to be 1231 mg/kg with 95% confidence limits of 860 to 1761 mg/kg. The acute dermal LD 50 for rabbits was determined to be greater than 8.0 g/kg. Based upon the observations made in the study, the estimated LD50 of the test material was determined to be greater than 8.0 g/kg. Therefore, the test substance is considered not to be classified according to CLP regulation . ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d140124-f3c7-4460-b9bd-f17169a5af0a/documents/a830f4f3-82de-41b2-b9c4-defbab39272a_9b23b09f-af4b-4ede-b7fd-9a7807438632.html,,,,,, "3,6-dioxaoctamethylenediamine",929-59-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d140124-f3c7-4460-b9bd-f17169a5af0a/documents/a830f4f3-82de-41b2-b9c4-defbab39272a_9b23b09f-af4b-4ede-b7fd-9a7807438632.html,,oral,LD50,"1,569 mg/kg bw",, "3,6-dioxaoctamethylenediamine",929-59-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d140124-f3c7-4460-b9bd-f17169a5af0a/documents/a830f4f3-82de-41b2-b9c4-defbab39272a_9b23b09f-af4b-4ede-b7fd-9a7807438632.html,,dermal,LD50,"8,000 mg/kg bw",, "3,7-bis(diethylamino)phenoxazin-5-ium acetate",79916-07-7," Prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound 3,7-bis(diethylamino)phenoxazin-5-ium acetate (79916-07-7). The study assumed the use of male and female Sprague-Dawley rats in subchronic study of 4 weeks on daily basis. No significant alterations were noted at the dose level of 186.1714mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for 3,7-bis(diethylamino)phenoxazin-5-ium acetate (79916-07-7)is considered to be 186.1714mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a93bb772-8936-4c31-a336-e47152eae486/documents/8e458116-769a-4f2e-905a-700d9c42d9ed_28f70032-ff36-4b68-9f7c-6f51d9e7e8ea.html,,,,,, "3,7-bis(diethylamino)phenoxazin-5-ium acetate",79916-07-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a93bb772-8936-4c31-a336-e47152eae486/documents/8e458116-769a-4f2e-905a-700d9c42d9ed_28f70032-ff36-4b68-9f7c-6f51d9e7e8ea.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,186.171 mg/kg bw/day,,rat "3,7-bis(diethylamino)phenoxazin-5-ium acetate",79916-07-7," Acute oral toxicity:  Based on the prediction done by SSS (2017) on 3,7-bis(diethylamino)phenoxazin-5-ium acetate, LD50 was estimated to be 707 mg/kg bw, when Wistar female rats were treated with 3,7-bis(diethylamino)phenoxazin-5-ium acetate via oral gavage route. Thus, comparing this value with the criteria of CLP regulation, 3,7-bis(diethylamino)phenoxazin-5-ium acetate can be classified as category IV for acute oral toxicity. Acute Inhalation toxicity:  Based on the prediction done by SSS (2017) on 3,7-bis(diethylamino)phenoxazin-5-ium acetate, LC50 was estimated to be 6.67 mg/L air, when male/female rats were exposed with 3,7-bis(diethylamino)phenoxazin-5-ium acetate for 7 h of exposure period. Thus, comparing this value with the criteria of CLP regulation, 3,7-bis(diethylamino)phenoxazin-5-ium acetate can be classified as category V for acute inhalation toxicity. Acute Dermal toxicity:  Based on the prediction done by SSS (2017) on 3,7-bis(diethylamino)phenoxazin-5-ium acetate, LD50 was estimated to be 5135 mg/kg bw, when New Zealand White male rabbit was treated with 3,7-bis(diethylamino)phenoxazin-5-ium acetate by dermal application. Thus, comparing this value with the criteria of CLP regulation, 3,7-bis(diethylamino) phenoxazin-5-ium acetate can be classified as category V for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a93bb772-8936-4c31-a336-e47152eae486/documents/f1e31afe-8050-4749-83f6-db757c2efd7c_28f70032-ff36-4b68-9f7c-6f51d9e7e8ea.html,,,,,, "3,7-bis(diethylamino)phenoxazin-5-ium acetate",79916-07-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a93bb772-8936-4c31-a336-e47152eae486/documents/f1e31afe-8050-4749-83f6-db757c2efd7c_28f70032-ff36-4b68-9f7c-6f51d9e7e8ea.html,,oral,LD50,707 mg/kg bw,adverse effect observed, "3,7-bis(diethylamino)phenoxazin-5-ium acetate",79916-07-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a93bb772-8936-4c31-a336-e47152eae486/documents/f1e31afe-8050-4749-83f6-db757c2efd7c_28f70032-ff36-4b68-9f7c-6f51d9e7e8ea.html,,dermal,LD50,"5,135 mg/kg bw",no adverse effect observed, "3,7-bis(diethylamino)phenoxazin-5-ium acetate",79916-07-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a93bb772-8936-4c31-a336-e47152eae486/documents/f1e31afe-8050-4749-83f6-db757c2efd7c_28f70032-ff36-4b68-9f7c-6f51d9e7e8ea.html,,inhalation,LC50,104.62 mg/m3,no adverse effect observed, "3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1)",63589-47-9," Prediction model based estimation and data available for the target chemical was reviewed to determine the toxic nature of 3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1) (63589-47-9)upon repeated exposure by oral, dermal and inhalation route of exposure. The studies are as mentioned below: Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound 3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1) (63589-47-9). The study assumed the use of male and female Wistar rats in subchronic study of 28days. No significant alterations were noted at the dose level of 667.080mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for compound3,7-bis(diethylamino) phenoxazin-5-ium tetrachlorozincate (2:1) is considered to be 667.080mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b90e2f9-d986-496e-bd20-64afd4f2b725/documents/e29715b6-636a-4b02-bea4-a80fc404c031_118a386c-cc46-4e86-ab4c-00318eb3cc34.html,,,,,, "3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1)",63589-47-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b90e2f9-d986-496e-bd20-64afd4f2b725/documents/e29715b6-636a-4b02-bea4-a80fc404c031_118a386c-cc46-4e86-ab4c-00318eb3cc34.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,667.08 mg/kg bw/day,,rat "3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1)",63589-47-9," Acute oral toxicity:  Acute oral toxicity dose (LD50) for 3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1) (CAS no: 63589-47-9) was predicted based on OECD QSAR toolbox 279 mg/kg bw and different study available on closely related read across substance Methyltriphenylphosphonium bromide (CAS no: 1779-49-3) by National Technical Reports Library (OTS0555371, 1992) 118 mg/kg bw. Both these studies concluded that the LD50 value is between 50-300 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1) can be classified as category 3 of acute oral toxicity. Acute Inhalation Toxicity: 3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1) (CAS no: 63589-47-9) has very low vapour pressure (2.27E-06 Pa at 25° C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal toxicity:  Acute oral toxicity dose (LD50) for 3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1) (CAS no: 63589-47-9) was predicted based on OECD QSAR toolbox 8222 mg/kg bw and different studies available on closely related read across substance N,N-dimethyl-p-toluidine (99-97-8) > 2000 mg/kg bw and Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts (84605-29-8) > 2000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1)can be classified as category 5 for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b90e2f9-d986-496e-bd20-64afd4f2b725/documents/b64b15bb-0aab-4252-9200-d4095b6c84c4_118a386c-cc46-4e86-ab4c-00318eb3cc34.html,,,,,, "3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1)",63589-47-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b90e2f9-d986-496e-bd20-64afd4f2b725/documents/b64b15bb-0aab-4252-9200-d4095b6c84c4_118a386c-cc46-4e86-ab4c-00318eb3cc34.html,,oral,LD50,279 mg/kg bw,adverse effect observed, "3,7-bis(diethylamino)phenoxazin-5-ium tetrachlorozincate (2:1)",63589-47-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b90e2f9-d986-496e-bd20-64afd4f2b725/documents/b64b15bb-0aab-4252-9200-d4095b6c84c4_118a386c-cc46-4e86-ab4c-00318eb3cc34.html,,dermal,LD50,"8,222 mg/kg bw",no adverse effect observed, "3,7-dihydropurin-6-one;sodium",45738-97-4," In an acute oral toxicity study in rats conducted according to OECD 423, the target substance Sodium Hypoxanthine showed no mortality at the limit dose of 2000 mg/kg bw. Hence, the LD50 value was considered to exceed 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4945d2e9-074e-4e7b-837b-411c1374d129/documents/701f9ac7-5307-4344-81bc-177374965e1f_06694960-2ed1-4536-a4f1-7f65feacd036.html,,,,,, "3,7-dimethyloct-1-en-3-yl acetate",68345-17-5,"Acute oral toxicity: No animal deceased in consequence of the single treatment with DMOE, a hydrolysis product of DMOE-Acetate, at a dose level of 2000 mg/kg bw via gavage, so that no LD50 could be determined and is therefore assumed to be >2000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable with restrictions ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ac71e28-ce47-4092-aa57-3ed8b98af4a2/documents/940cbf09-3fd2-4b2f-acf8-d9af5ce6ec04_8faac078-1f7f-4779-93c1-9d805e52de39.html,,,,,, "3,7-dimethyloct-1-en-3-yl acetate",68345-17-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ac71e28-ce47-4092-aa57-3ed8b98af4a2/documents/940cbf09-3fd2-4b2f-acf8-d9af5ce6ec04_8faac078-1f7f-4779-93c1-9d805e52de39.html,,oral,LD50,"> 2,500 mg/kg bw",no adverse effect observed, "3,7-dinitroso-1,3,5,7-tetraazabicyclo[3.3.1]nonane",101-25-7, REACH_LD50 = 940 mg/kg bw | rat | - | #WoE# ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/499d49a4-4a97-4f1c-83a7-3d9bc95966a8/documents/b3f36f8c-fa53-4084-b88a-19266162052b_55e11214-a1b5-41bb-967a-3b15e0800c37.html,,,,,, "3,7-dinitroso-1,3,5,7-tetraazabicyclo[3.3.1]nonane",101-25-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/499d49a4-4a97-4f1c-83a7-3d9bc95966a8/documents/b3f36f8c-fa53-4084-b88a-19266162052b_55e11214-a1b5-41bb-967a-3b15e0800c37.html,,oral,LD50,940 mg/kg bw,adverse effect observed, "3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane",80693-00-1,The no-observable-effect-level (NOEL) of the test substance in dogs via capsule administration for a period of 3 months was determined to be 2000 mg/kg/day. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7c99b50-814f-44e5-affe-2a002933c34a/documents/IUC5-f2710bd5-604a-4229-bf7f-d486ca7c9a1f_3b117df2-f83f-45ff-8b30-3cadab939b71.html,,,,,, "3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane",80693-00-1,The acute lethal oral dose to rats was found to be: greater than 5.0 g / kg bodyweightThe acute lethal dermal dose to rats was found to be: greater than 2.0 g / kg bodyweightThe acute inhalation study is waived because of low vapour pressure and low exposure. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7c99b50-814f-44e5-affe-2a002933c34a/documents/IUC5-d860b70c-da7e-4a6e-8440-2d5e2e0a076c_3b117df2-f83f-45ff-8b30-3cadab939b71.html,,,,,, "3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane",80693-00-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7c99b50-814f-44e5-affe-2a002933c34a/documents/IUC5-d860b70c-da7e-4a6e-8440-2d5e2e0a076c_3b117df2-f83f-45ff-8b30-3cadab939b71.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3,9-bis(2,6-di-tert-butyl-4-methylphenoxy)-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane",80693-00-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7c99b50-814f-44e5-affe-2a002933c34a/documents/IUC5-d860b70c-da7e-4a6e-8440-2d5e2e0a076c_3b117df2-f83f-45ff-8b30-3cadab939b71.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "bis(2,4-dicumylphenyl) neopentyl diphosphite 3,9-bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane",154862-43-8," Subacute NOAEL (rat, male/female): 200 mg/kg bw/day (Directive 92/69 EEC, B.7/GLP) Subacute NOEL (rat, male/female): 200 mg/kg bw/day (Directive 92/69 EEC, B.7/GLP) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4ed4f42-6bf5-485b-85a5-14eb37e034f3/documents/f75f6f04-44cf-4a4b-b815-0ce30ecc83d2_0d9d53f9-b9b7-4c74-9ce8-1b404c554be4.html,,,,,, "bis(2,4-dicumylphenyl) neopentyl diphosphite 3,9-bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane",154862-43-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4ed4f42-6bf5-485b-85a5-14eb37e034f3/documents/f75f6f04-44cf-4a4b-b815-0ce30ecc83d2_0d9d53f9-b9b7-4c74-9ce8-1b404c554be4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "bis(2,4-dicumylphenyl) neopentyl diphosphite 3,9-bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane",154862-43-8, Acute toxicity (oral): LD50 (male/female) >5000 mg/kg bw Acute toxicity (inhalation): Waiver Acute toxicity (dermal): LD50 (male/female) >2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4ed4f42-6bf5-485b-85a5-14eb37e034f3/documents/f9cb8f2e-1c1f-4f39-ad0b-6c073637de8e_0d9d53f9-b9b7-4c74-9ce8-1b404c554be4.html,,,,,, "bis(2,4-dicumylphenyl) neopentyl diphosphite 3,9-bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane",154862-43-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4ed4f42-6bf5-485b-85a5-14eb37e034f3/documents/f9cb8f2e-1c1f-4f39-ad0b-6c073637de8e_0d9d53f9-b9b7-4c74-9ce8-1b404c554be4.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "bis(2,4-dicumylphenyl) neopentyl diphosphite 3,9-bis[2,4-bis(1-methyl-1-phenylethyl)phenoxy]-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane",154862-43-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4ed4f42-6bf5-485b-85a5-14eb37e034f3/documents/f9cb8f2e-1c1f-4f39-ad0b-6c073637de8e_0d9d53f9-b9b7-4c74-9ce8-1b404c554be4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,9-dibenzyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide",20544-37-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9162fc3-f0b2-458c-8a8c-b8dded21eee5/documents/4d8c1cd9-c06f-4110-a7a6-902f6cb113ba_89899230-92ca-44d1-b52b-28135647cb5e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,9-dicyclohex-3-enyl-2,4,8,10-tetraoxaspiro[5.5]undecane",6600-31-3,"3,9-Di-3-cyclohexen-1-yl-2,4,8,10-tetraoxaspiro[5,5]undecane was administered by gavage to 5 male and 5 female Wistar rats per dose group in daily doses of 0, 100, 300 or 1000 mg/kg body weight for 29 days. The animals were regularly observed and weighed and food and water intakes were determined. In addition, clinical pathology of blood samples was performed. Organs and tissues were subjected to gross and histopathological investigation. Functional observational battery (FOB) and motor and locomotor activity measurements (MA/LMA) were done. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/939ad001-6ebb-4929-b885-83ad068e3a90/documents/IUC5-bc18027c-8eb8-469d-a78b-1133cc38d55f_767bbbdf-01d4-49cb-a4f5-8259633bca59.html,,,,,, "3,9-dicyclohex-3-enyl-2,4,8,10-tetraoxaspiro[5.5]undecane",6600-31-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/939ad001-6ebb-4929-b885-83ad068e3a90/documents/IUC5-bc18027c-8eb8-469d-a78b-1133cc38d55f_767bbbdf-01d4-49cb-a4f5-8259633bca59.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "3,9-dicyclohex-3-enyl-2,4,8,10-tetraoxaspiro[5.5]undecane",6600-31-3,A valid acute oral and dermal toxicity study and 2 acute inhalation toxicity studies are available. In the acute inhalation toxicity studies no exact LC50 values were determined. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/939ad001-6ebb-4929-b885-83ad068e3a90/documents/IUC5-85cabaec-3a8b-40c9-a1f8-140bf74f5c3a_767bbbdf-01d4-49cb-a4f5-8259633bca59.html,,,,,, "3,9-dicyclohex-3-enyl-2,4,8,10-tetraoxaspiro[5.5]undecane",6600-31-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/939ad001-6ebb-4929-b885-83ad068e3a90/documents/IUC5-85cabaec-3a8b-40c9-a1f8-140bf74f5c3a_767bbbdf-01d4-49cb-a4f5-8259633bca59.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "3,9-dicyclohex-3-enyl-2,4,8,10-tetraoxaspiro[5.5]undecane",6600-31-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/939ad001-6ebb-4929-b885-83ad068e3a90/documents/IUC5-85cabaec-3a8b-40c9-a1f8-140bf74f5c3a_767bbbdf-01d4-49cb-a4f5-8259633bca59.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "3,9-dicyclohex-3-enyl-2,4,8,10-tetraoxaspiro[5.5]undecane",6600-31-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/939ad001-6ebb-4929-b885-83ad068e3a90/documents/IUC5-85cabaec-3a8b-40c9-a1f8-140bf74f5c3a_767bbbdf-01d4-49cb-a4f5-8259633bca59.html,,inhalation,discriminating conc.,"6,742 mg/m3",adverse effect observed, "3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide",3001-98-7,"RD oral: NOAEL (rat) = 1000 mg/kg/day (OECD 408 + 422); no hazard identified; RC not required, no DNEL necessary RD dermal: waived (scientifically not justified), WoE: no classification necessary; no DNEL necessaryRD inhalation: waived (exposure considerations), WoE: no classification necessary; no DNEL necessary ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/153dc3f0-9828-4f16-9557-71edc4e75cad/documents/45a36aaa-6d3c-46c1-a798-a667a79a7545_191a5efb-138c-4da4-add9-2d844adc63f3.html,,,,,, "3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide",3001-98-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/153dc3f0-9828-4f16-9557-71edc4e75cad/documents/45a36aaa-6d3c-46c1-a798-a667a79a7545_191a5efb-138c-4da4-add9-2d844adc63f3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide",3001-98-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/153dc3f0-9828-4f16-9557-71edc4e75cad/documents/45a36aaa-6d3c-46c1-a798-a667a79a7545_191a5efb-138c-4da4-add9-2d844adc63f3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide",3001-98-7, acute oral LD50 > 5000 mg/kg bw (OECD 425 limit test) acute dermal LD50 > 2000 mg/kg bw (OECD 402 limit test); Each rat was symptom-free during the entire study. There was no evidence for an adverse effect. acute inhalation toxicity: waived ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/153dc3f0-9828-4f16-9557-71edc4e75cad/documents/ce080d9a-3078-420c-b03a-95ba0068d2c0_191a5efb-138c-4da4-add9-2d844adc63f3.html,,,,,, "3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide",3001-98-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/153dc3f0-9828-4f16-9557-71edc4e75cad/documents/ce080d9a-3078-420c-b03a-95ba0068d2c0_191a5efb-138c-4da4-add9-2d844adc63f3.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,9-dimethyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide",3001-98-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/153dc3f0-9828-4f16-9557-71edc4e75cad/documents/ce080d9a-3078-420c-b03a-95ba0068d2c0_191a5efb-138c-4da4-add9-2d844adc63f3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-[(2-hydroxyethyl)amino]propionamide,27076-30-8,In order to test the acute oral toxicity of the test substance ACMEO an OECD 401 Study is available ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d36c6b38-2fbf-4263-8565-a5c8d61c0bb6/documents/IUC5-0ce2cc46-f593-436c-8864-3dfb7487edbb_7e19bde4-2249-4b87-8b28-27172ed155c4.html,,,,,, 3-[(4-aminobenzoyl)amino]propanoic acid,7377-08-4," From the available rat and human data, it is clear that when the body is exposed to 4-aminobenzoyl-b-alanine where it is not directly injected into the blood, e.g. oral, dermal and inhalation exposure, that significant metabolism of any 4-aminobenzoyl-b-alanine which passes into the membrane (skin/GI tract/lungs) will occur via N-acetyl transferases (NATs) converting 4-aminobenzoyl-b-alanine to NABA which is then rapidly excreted from the body via the urine (potentially via active secretion in kidneys). It can also reasonably be expected that absorption via skin would be much slower and to a lesser degree than via the oral route, allowing more time for conversion of relatively less absorbed 4-aminobenzoyl-b-alanine to NABA which would then be rapidly removed from the body as soon as reaching the systemic circulation. The negative results obtained in the in vitro genotoxicity studies performed with 4-aminobenzoyl-b-alanine also show that there is no non-threshold mode of action for carcinogenicity. Furthermore, exposure to 4-aminobenzoyl-b-alanine will be negligible since it used as a pharmaceutical intermediate only and hence professionals will be working under strict GMP conditions. Oral exposure to workers will not occur and inhalation and dermal exposure will be negligible based on the physico-chemical properties of 4-aminobenzoyl-b-alanine. Therefore, based on the rapid excretion of 4-aminobenzoyl-b-alanine from the body and the lack of exposure to professionals, repeated dose toxicity is not predicted and in vivo testing is considered scientifically unjustified. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/653cd2ad-5f0e-4603-b5ef-722e60a41d00/documents/40fcf607-03b3-42dd-8698-b6b6e68c5f55_5d13977f-d277-437e-8191-877c8c3fd3cd.html,,,,,, 3-[(4-aminobenzoyl)amino]propanoic acid,7377-08-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/653cd2ad-5f0e-4603-b5ef-722e60a41d00/documents/40fcf607-03b3-42dd-8698-b6b6e68c5f55_5d13977f-d277-437e-8191-877c8c3fd3cd.html,Chronic toxicity – systemic effects,oral,LOAEL,68 mg/kg bw/day,,other:QSAR 3-[(4-aminobenzoyl)amino]propanoic acid,7377-08-4," The acute oral toxicity study in rats shows that 4-aminobenzoyl-b-alanine is not toxic when administered as a single oral dose of 1000 mg/kg bw. No mortalities, adverse effects or clinical signs were observed during the study and this result is supported by the QSAR prediction performed using the U.S. EPA Toxicity Estimation Software Tool v4.2.1 (T.E.S.T.). Both 4-aminobenzoyl-b-alanine (ABA) and its N-acetylated metabolite (NABA) are rapidly excreted from the systemic circulation via urine (see separate study summaries for TK (oral and iv)) without any bioaccumulation (based on the rate of excretion and its negative log Pow of -1.19). Therefore, ABA administered in an acute oral toxicity test would be rapidly removed from the rat, with very low risk of achieving toxic levels in any of the rat’s vital organs and hence highly unlikely to cause mortality especially since the maximum dose is only a factor of 2 higher than the 1000 mg/kg already shown to produce no mortality. For acute toxicity therefore, it can be reasonably predicted, without the performance of a study, that the LD50 is > 2000 mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/653cd2ad-5f0e-4603-b5ef-722e60a41d00/documents/5a597c27-f02c-4fc4-825b-e5abe69997bd_5d13977f-d277-437e-8191-877c8c3fd3cd.html,,,,,, 3-[(4-aminobenzoyl)amino]propanoic acid,7377-08-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/653cd2ad-5f0e-4603-b5ef-722e60a41d00/documents/5a597c27-f02c-4fc4-825b-e5abe69997bd_5d13977f-d277-437e-8191-877c8c3fd3cd.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-[(4-chloro-2-nitrophenyl)azo]-2-methylpyrazolo[5,1-b]quinazolin-9(1H)-one",74336-59-7,"oralRepeated Dose Toxicity Study: NOAEL for systemic toxicity (males/females): 1000 mg/kg bw /d based on the clinical, the clinical pathological and histopathological findings (BASF 85R0060/11C032, 2012), OECD 422, GLP, rat, gavagedermalno datainhalationno dataNo substance-related effects were observed after repeated oral administration of high doses to animals. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c84b1bf0-0cfd-4d06-9c56-575211757c42/documents/IUC5-959bff7c-b6ff-4aa1-9ee4-5f7929b63cfb_be7f7fe9-9d65-4a01-aef8-020f71534567.html,,,,,, "3-[(4-chloro-2-nitrophenyl)azo]-2-methylpyrazolo[5,1-b]quinazolin-9(1H)-one",74336-59-7,"Oral: LD50 > 5000 mg/kg bw (BASF: 80/404, 1981), rat (equivalent or similar to OECD 401). No adverse effects were observed.Intraperitoneal: LD50 > 2000 mg/kg bw (BASF: 80/404, 1981), mouse. No adverse effects were observed. Based on the absence of mortality upon intraperitonel injection, testing of acute dermal toxicity was not considered necessary. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c84b1bf0-0cfd-4d06-9c56-575211757c42/documents/IUC5-57dffedc-a808-4e11-b07e-cde1ba94e678_be7f7fe9-9d65-4a01-aef8-020f71534567.html,,,,,, 3-[(phenylcarbamoyl)amino]phenyl 4-methylbenzene-1-sulfonate,2102522-55-2," Fujii (2021) Under the conditions of the study the NOAEL for repeated dose toxicity of the test material in adults was considered to be 1000 mg/kg/day. No adverse effects related to test material administration were observed. As such, in accordance with the criteria for classification as defined in Annex I, Regulation (EC) No 1272/2008, the substance does not require classification with respect to repeated dose toxicity. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8349cf07-643d-4bcc-9bac-2ee3fb3484b3/documents/18a2f0a8-5b45-4615-b256-f1806e8f5adb_56e0407e-a3f0-46ff-9810-621d3100a6fb.html,,,,,, 3-[(phenylcarbamoyl)amino]phenyl 4-methylbenzene-1-sulfonate,2102522-55-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8349cf07-643d-4bcc-9bac-2ee3fb3484b3/documents/18a2f0a8-5b45-4615-b256-f1806e8f5adb_56e0407e-a3f0-46ff-9810-621d3100a6fb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 3-[(phenylcarbamoyl)amino]phenyl 4-methylbenzene-1-sulfonate,2102522-55-2,"Acute oral toxicity (2017) Under the conditions of the study, the acute oral LD50 of the test material was determined to be > 2000 mg/kg bw in female rats.     Acute inhalation toxicity (2021) Under the conditions of this study the 4-hour LC50 of the test material in rats was considered to be > 3.38 mg/L since no adverse effects were noted at the highest attainable test concentration.     Acute dermal toxicity (2018) Under the conditions of the study the acute dermal toxicity of the test material to rats was considered to be > 2000 mg/kg bw.   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8349cf07-643d-4bcc-9bac-2ee3fb3484b3/documents/38315849-d1d8-4e43-a346-ee2e83354016_56e0407e-a3f0-46ff-9810-621d3100a6fb.html,,,,,, 3-[(phenylcarbamoyl)amino]phenyl 4-methylbenzene-1-sulfonate,2102522-55-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8349cf07-643d-4bcc-9bac-2ee3fb3484b3/documents/38315849-d1d8-4e43-a346-ee2e83354016_56e0407e-a3f0-46ff-9810-621d3100a6fb.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 3-[(phenylcarbamoyl)amino]phenyl 4-methylbenzene-1-sulfonate,2102522-55-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8349cf07-643d-4bcc-9bac-2ee3fb3484b3/documents/38315849-d1d8-4e43-a346-ee2e83354016_56e0407e-a3f0-46ff-9810-621d3100a6fb.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 3-[(phenylcarbamoyl)amino]phenyl 4-methylbenzene-1-sulfonate,2102522-55-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8349cf07-643d-4bcc-9bac-2ee3fb3484b3/documents/38315849-d1d8-4e43-a346-ee2e83354016_56e0407e-a3f0-46ff-9810-621d3100a6fb.html,,inhalation,LC50,> 3.38 mg/L,no adverse effect observed, 3-[[2-(2-cyanoethoxy)ethyl][4-[(4-nitrophenyl)azo]phenyl]amino]propiononitrile,70210-10-5,Acute oral toxicity in rats by gavage.LD50 = 636.3 mg/kg bw as active ingredient. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f82e6872-a74b-4fa8-9fb8-0a5c1b5b6a17/documents/IUC5-b198336d-ed4a-49c3-a99d-51c5a70b6fa3_985ad0c4-3fc4-4c55-bb55-27583169fa55.html,,,,,, 3-[[2-(2-cyanoethoxy)ethyl][4-[(4-nitrophenyl)azo]phenyl]amino]propiononitrile,70210-10-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f82e6872-a74b-4fa8-9fb8-0a5c1b5b6a17/documents/IUC5-b198336d-ed4a-49c3-a99d-51c5a70b6fa3_985ad0c4-3fc4-4c55-bb55-27583169fa55.html,,oral,LD50,636.3 mg/kg bw,adverse effect observed, 3-[[2-(acetyloxy)ethyl][4-[(4-nitrophenyl)azo]phenyl]amino]propiononitrile,68391-42-4, Acute toxicity in rats LD50 > 2000 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a8effa3-5496-4f7b-b5e9-242593a0f6f5/documents/024bed6e-a9d4-4086-834a-826d12a29282_c682664c-6b4e-4fc5-929e-ae18504b3e86.html,,,,,, 3-[[3-(dimethylamino)propyl]amino]propiononitrile,69852-45-5, The repeated dose toxicity via dermal exposure of Aradur 1019 in the rabbit was tested. Results show No Observed Effect Level of 20 mg/kg bw/day. Effects were seen on dermal irritation and corrosion at 100 mg/kg bw/day leading to a classification of STOT RE Cat. 2 ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e7b3f09-f94a-4061-b89b-6b2fecefe675/documents/f8d9c73e-03fd-46de-86b9-bfe892351401_780279a3-ffbe-4b0c-a719-969ceffdfd38.html,,,,,, 3-[[3-(dimethylamino)propyl]amino]propiononitrile,69852-45-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e7b3f09-f94a-4061-b89b-6b2fecefe675/documents/f8d9c73e-03fd-46de-86b9-bfe892351401_780279a3-ffbe-4b0c-a719-969ceffdfd38.html,Chronic toxicity – systemic effects,dermal,NOAEL,20 mg/kg bw/day,,rabbit 3-[[3-(dimethylamino)propyl]amino]propiononitrile,69852-45-5," The acute toxicity of Aradur 1019 via oral and dermal routes have been determined. Both studies were carried out before published methods, such as OECD guidelines, were available. The methodology used is equivalent to the current guidelines in all cases. The results are reported: Acute oral LD50 2284 mg/kg bw Acute dermal LD50 >4500 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e7b3f09-f94a-4061-b89b-6b2fecefe675/documents/a60bbeb9-d586-4b2a-b026-dabd7b86ef1a_780279a3-ffbe-4b0c-a719-969ceffdfd38.html,,,,,, 3-[[3-(dimethylamino)propyl]amino]propiononitrile,69852-45-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e7b3f09-f94a-4061-b89b-6b2fecefe675/documents/a60bbeb9-d586-4b2a-b026-dabd7b86ef1a_780279a3-ffbe-4b0c-a719-969ceffdfd38.html,,oral,LD50,"2,284 mg/kg bw",no adverse effect observed, 3-[[3-(dimethylamino)propyl]amino]propiononitrile,69852-45-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e7b3f09-f94a-4061-b89b-6b2fecefe675/documents/a60bbeb9-d586-4b2a-b026-dabd7b86ef1a_780279a3-ffbe-4b0c-a719-969ceffdfd38.html,,dermal,LD50,"4,500 mg/kg bw",no adverse effect observed, "3-[[3-[[(2-cyanoethyl)amino]methyl]-3,5,5-trimethylcyclohexyl]amino]propiononitrile",93940-97-7,"In a supporting Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (OECD TG 422), the oral administration of the test item by gavage to Wistar rats revealed adverse findings at 150 mg/kg bw/d regarding body weight, haematology, clinical biochemistry, organ weight and hisopathology endpoints. Thus, the no observed adverse effect level (NOAEL) for general systemic toxicity was 50 mg/kg bw/d [BASF, 2019]. That study served as the dose-range-finding study for a subsequent sub-chronic repeated dose toxicity study. In the key study, the oral toxicity of 3-[[3-[[(2-cyanoethyl)amino]methyl]-3,5,5-trimethylcyclohexyl]amino] propiononitrile was investigated in Wistar Hannover rats after daily oral administration for 13 weeks (OECD TG 408). Based on the results of that study, it can it can be concluded that the No Observed Adverse Effect Level (NOAEL) for males and females was 100 mg/kg/day [BASF, 2022]. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): modern GLP guideline study ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f95b7545-db90-4a8d-ad7d-109d22eb0137/documents/0a720570-0f52-49c0-994e-739443741e3f_17690e4d-9b86-40b4-857d-5bcd071d9852.html,,,,,, "3-[[3-[[(2-cyanoethyl)amino]methyl]-3,5,5-trimethylcyclohexyl]amino]propiononitrile",93940-97-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f95b7545-db90-4a8d-ad7d-109d22eb0137/documents/0a720570-0f52-49c0-994e-739443741e3f_17690e4d-9b86-40b4-857d-5bcd071d9852.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "3-[[3-[[(2-cyanoethyl)amino]methyl]-3,5,5-trimethylcyclohexyl]amino]propiononitrile",93940-97-7," Under the conditions of an OECD 423 compliant GLP study the median lethal dose of the test item after oral administration was found to be greater than 500 mg/kg and less than 2000 mg/kg body weight in female rats. LD50 (oral) > 500 mg/kg < 2000 mg/kg bw/d (OECD 423, BASF 2005) LD50 (dermal) > 2000 mg/kg bw/d (OECD 402, BASF 2018) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f95b7545-db90-4a8d-ad7d-109d22eb0137/documents/a590317c-e55c-4719-b93b-4cc73cc9ba8b_17690e4d-9b86-40b4-857d-5bcd071d9852.html,,,,,, "3-[[3-[[(2-cyanoethyl)amino]methyl]-3,5,5-trimethylcyclohexyl]amino]propiononitrile",93940-97-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f95b7545-db90-4a8d-ad7d-109d22eb0137/documents/a590317c-e55c-4719-b93b-4cc73cc9ba8b_17690e4d-9b86-40b4-857d-5bcd071d9852.html,,oral,discriminating dose,500 mg/kg bw,adverse effect observed, "3-[[3-[[(2-cyanoethyl)amino]methyl]-3,5,5-trimethylcyclohexyl]amino]propiononitrile",93940-97-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f95b7545-db90-4a8d-ad7d-109d22eb0137/documents/a590317c-e55c-4719-b93b-4cc73cc9ba8b_17690e4d-9b86-40b4-857d-5bcd071d9852.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-[[4-[(2,6-dibromo-4-nitrophenyl)azo]phenyl]ethylamino]propiononitrile",55281-26-0,"LOAEL repeated, m+f, oral, OECD422 = 20 mg/kg bw (hystopathology, nervous system) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc876c94-d431-4b55-8467-fe26050dbc5b/documents/f0bbff44-e493-4794-9412-d6f4c4cfcfe9_ef7a02d2-99af-4bb7-94d4-16f7f1b3bde8.html,,,,,, "3-[[4-[(2,6-dibromo-4-nitrophenyl)azo]phenyl]ethylamino]propiononitrile",55281-26-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc876c94-d431-4b55-8467-fe26050dbc5b/documents/f0bbff44-e493-4794-9412-d6f4c4cfcfe9_ef7a02d2-99af-4bb7-94d4-16f7f1b3bde8.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,ca.20 mg/kg bw/day,,rat 3-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]propiononitrile,40880-51-1," Acute toxicity in rats LD50 = 3980 mg/kg, corresponding to 1592 mg/kg a.i.. LD50 = 4970 mg/kg, corresponding to 1759 mg/kg a.i.. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af0a9ca5-fd26-4ac7-9104-94c84e1b2b6b/documents/8443eab1-73c2-4986-91ee-fad9266467f1_50184cc4-bd69-4f80-a935-86acf48e0618.html,,,,,, 3-[[4-[(2-chloro-4-nitrophenyl)azo]phenyl]ethylamino]propiononitrile,40880-51-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af0a9ca5-fd26-4ac7-9104-94c84e1b2b6b/documents/8443eab1-73c2-4986-91ee-fad9266467f1_50184cc4-bd69-4f80-a935-86acf48e0618.html,,oral,LD50,"1,592 mg/kg bw",adverse effect observed, "3-[[9,10-dihydro-9,10-dioxo-4-[(p-tolyl)amino]-1-anthryl]aminopropyl]trimethylammonium methyl sulphate",72828-93-4," In a GLP guideline study from 1990, the LD50 (oral, gavage) of the test substance in male/female rats was found to be >2000 mg/kg bw (corresponding to 960 mg/kg bw act. ingr.). 1/5 female rats died and had clinical symptoms and pathological findings. 4/5 female and 5/5 male rats survived without any findings. However, since the dye content was only 48% and the content of active ingredient too low to exclude a classification according to CLP criteria, a second study from 1974 (equivalent to guideline study) was taken into account for a weight-of-evidence approach: under the study conditions, the LD50 (oral, gavage) of the test substance in male rats was determined at 2115 mg/kg bw (act. ingr.). Based on both results, the substance is not classifiable according to CLP criteria. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e78fb65-48a7-4356-980c-dba49f402cf5/documents/9c021128-db0c-4dd7-8899-6a4f3ca05004_a27d75ce-6f32-4a08-9360-952ec6744fb7.html,,,,,, "3-[[9,10-dihydro-9,10-dioxo-4-[(p-tolyl)amino]-1-anthryl]aminopropyl]trimethylammonium methyl sulphate",72828-93-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e78fb65-48a7-4356-980c-dba49f402cf5/documents/9c021128-db0c-4dd7-8899-6a4f3ca05004_a27d75ce-6f32-4a08-9360-952ec6744fb7.html,,oral,LD50,"2,115 mg/kg bw",no adverse effect observed, "3-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]disiloxanyl]propyl methacrylate",17096-07-0," In the key 28-day oral study, conducted according to a protocol similar to OECD TG 407, and in compliance with GLP, the reported NOAEL value for 3-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]disiloxanyl]propyl methacrylate was 80 mg/kg bw/day in rats (TNO, 1989). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33ced7d0-9ab8-4926-95fd-2fe2b28d6e41/documents/abf994f5-9aa1-4192-b694-61e74ef0818e_0d31e011-7675-4d76-b172-2110a38af961.html,,,,,, "3-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]disiloxanyl]propyl methacrylate",17096-07-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33ced7d0-9ab8-4926-95fd-2fe2b28d6e41/documents/abf994f5-9aa1-4192-b694-61e74ef0818e_0d31e011-7675-4d76-b172-2110a38af961.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat "3-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]disiloxanyl]propyl methacrylate",17096-07-0," In the key acute oral toxicity study, conducted to the now deleted OECD TG 401 and in compliance with GLP, the reported LD50 value was greater than 10.0 mL/kg bw (equivalent to 9250 mg/kg bw) (CIVO, 1988). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33ced7d0-9ab8-4926-95fd-2fe2b28d6e41/documents/dbcd583f-98b6-4e09-89aa-e238bbda4515_0d31e011-7675-4d76-b172-2110a38af961.html,,,,,, "3-[3,3,3-trimethyl-1,1-bis[(trimethylsilyl)oxy]disiloxanyl]propyl methacrylate",17096-07-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33ced7d0-9ab8-4926-95fd-2fe2b28d6e41/documents/dbcd583f-98b6-4e09-89aa-e238bbda4515_0d31e011-7675-4d76-b172-2110a38af961.html,,oral,LD50,"9,250 mg/kg bw",no adverse effect observed, 3-[ethyl[4-[(4-nitrophenyl)azo]phenyl]amino]propiononitrile,31482-56-1," Under the conditions of the study, the acute LD50 value of the test material was found to be > 2000 mg/kg bw in female Crl:WI rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/388fdd24-42b2-4530-b2cb-5c5c3dff9571/documents/b4e2a766-1213-4544-9612-da1b197e2454_95dfdf34-b9ad-4dd2-9ec2-2ae257e7aa4c.html,,,,,, 3-[ethyl[4-[(4-nitrophenyl)azo]phenyl]amino]propiononitrile,31482-56-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/388fdd24-42b2-4530-b2cb-5c5c3dff9571/documents/b4e2a766-1213-4544-9612-da1b197e2454_95dfdf34-b9ad-4dd2-9ec2-2ae257e7aa4c.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, 3-[tris(acetoxy)silyl]propyl methacrylate,51772-85-1,"In accordance with Column 2 of REACH Annex VII, testing for acute toxicity by the oral route does not need to be conducted as 3-[tris(acetoxy)silyl]propyl methacrylate (CAS RN:51772-85-1, EC No:257-407-3) is classified as corrosive to the skin. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc447c75-b3bb-4f01-baf0-a3963321afb0/documents/41ef88ba-2843-4455-994b-073630466638_c31f1fdd-d7f1-42c2-a396-dbada043a96d.html,,,,,, "3a,4,7,7a-tetrahydro-4,7-methanoindene",77-73-6," In an OECD 408 guideline study, rats dosed with 100 mg/kg/day DCPD had sporadic tremors and clonic convulsions. The NOAEL was concluded to be 30 mg/kg/day. In non-guideline oral and an inhalation studies, exposure to dicyclopentadiene resulted in nephrotoxicity (alterations in renal function and kidney morphology) in male rats only and characteristic of hyaline droplet nephropathy, which is not relevant for human risk assessment. Other changes which were seen in male rats in all groups (including controls) were characteristic of chronic glomerulonephropathy. Mortality was seen in rats dosed with 100 mg/kg/day orally and in mice exposed to 51 ppm by inhalation. Apart from the effects on the kidney (in male rats only), there were few histopathological changes. Single cell necrosis in the liver and fatty changes in the adrenal glands were seen in the oral rat study only. The subchronic NOAEC in rats for DCPD is 107 mg/m3. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06628ee4-7bd0-4483-8b07-af3b341edd92/documents/0a2532af-4637-4bd0-bebb-ee4e01a9b604_7be20324-82bf-461a-a871-e465390798e5.html,,,,,, "3a,4,7,7a-tetrahydro-4,7-methanoindene",77-73-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06628ee4-7bd0-4483-8b07-af3b341edd92/documents/0a2532af-4637-4bd0-bebb-ee4e01a9b604_7be20324-82bf-461a-a871-e465390798e5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,4 mg/kg bw/day,,rat "3a,4,7,7a-tetrahydro-4,7-methanoindene",77-73-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06628ee4-7bd0-4483-8b07-af3b341edd92/documents/0a2532af-4637-4bd0-bebb-ee4e01a9b604_7be20324-82bf-461a-a871-e465390798e5.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,27.6 mg/m3,,mouse "3a,4,7,7a-tetrahydro-4,7-methanoindene",77-73-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06628ee4-7bd0-4483-8b07-af3b341edd92/documents/0a2532af-4637-4bd0-bebb-ee4e01a9b604_7be20324-82bf-461a-a871-e465390798e5.html,Repeated dose toxicity – local effects,inhalation,NOAEC,27.6 mg/m3,adverse effect observed,mouse "3a,4,7,7a-tetrahydro-4,7-methanoindene",77-73-6," Dicyclopentadiene is of slight - moderate acute toxicity by the oral and inhalation routes (oral LD50 590 mg/kg, inhalation 4 hour LC50 1972 mg/m3) and is practically non-toxic by the dermal route (dermal LD50 > 2000 mg/kg). The NOAEC for irregular breathing, stereotypic behaviour in rats and mice has been reported to be 248.74 mg/m3 (Bushy Run, 1981). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06628ee4-7bd0-4483-8b07-af3b341edd92/documents/IUC5-3c4ac599-fa56-408e-b0b1-881190c836e9_7be20324-82bf-461a-a871-e465390798e5.html,,,,,, "3a,4,7,7a-tetrahydro-4,7-methanoindene",77-73-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06628ee4-7bd0-4483-8b07-af3b341edd92/documents/IUC5-3c4ac599-fa56-408e-b0b1-881190c836e9_7be20324-82bf-461a-a871-e465390798e5.html,,oral,LD50,590 mg/kg bw,adverse effect observed, "3a,4,7,7a-tetrahydro-4,7-methanoindene",77-73-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06628ee4-7bd0-4483-8b07-af3b341edd92/documents/IUC5-3c4ac599-fa56-408e-b0b1-881190c836e9_7be20324-82bf-461a-a871-e465390798e5.html,,inhalation,LC50,"1,972 mg/m3",adverse effect observed, 3-acetamido-5-amino-4-hydroxybenzenesulphonic acid,40306-75-0, An acute toxicity LD50 value 0f >5000 mg/kg bw was given in an internal product data sheet. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dc032e6-a1e1-4393-80fd-cab768338aca/documents/55854211-1e7b-4b81-9a2f-e63b91979619_855a848d-2bc4-4539-9bd2-b829902be9c3.html,,,,,, "3-Amidino-1-(2-fluorbenzyl)-1H-pyrazolo[3,4b]pyridin-hydrochlorid",256499-19-1,"No experimental data on acute toxicity of the test item is available. An in silico and read-across prediction for acute oral toxicity was conducted on March 19, 2024 using four different tools (DEREK, Leadscope, EPA TEST, OECD TB). The test item was predicted to have an acute oral toxicity and shall be classified with Cat. 4. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03227a1a-2c59-4eff-8cc1-a321c0e707f4/documents/1e7c8593-911b-4db5-acdc-97c6bd57eeff_d12e8f87-455e-44aa-8204-e407bf3ef661.html,,,,,, "3-amino-5-hydroxynaphthalene-2,7-disulphonic acid",90-40-4," LD50 was estimated to be 3359.94 mg/kg bw, when male and female wistar rat were exposed with 3-amino-5-hydroxynaphthalene-2,7-disulfonic acid (90-40-4) orally. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f87f1557-f2f6-46d4-95ee-e6060f051241/documents/c4af5a2b-c5c2-4fe6-ac43-7a1bc794815e_0170766e-4333-4852-9e81-3239862cbd8b.html,,,,,, "3-amino-5-hydroxynaphthalene-2,7-disulphonic acid",90-40-4,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f87f1557-f2f6-46d4-95ee-e6060f051241/documents/c4af5a2b-c5c2-4fe6-ac43-7a1bc794815e_0170766e-4333-4852-9e81-3239862cbd8b.html,,oral,LD50,"3,359.94 mg/kg bw",no adverse effect observed, 3-aminobenzenesulphonic acid,121-47-1,"no key study, there are only supporting information available ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9415d0e-48d1-451b-8b01-6437e7182689/documents/0f7937b1-2066-41c1-aead-5308e8ab889d_e00b70af-35b7-452d-936e-06270e28e34d.html,,,,,, 3-aminobenzenesulphonic acid,121-47-1,The oral LD50 for male and female rats was greater than 5000 mg/kg bw. Metanilic acid wet (free acid) did not cause any formation of methemoglobin nor did it induce any HEINZ bodies in the blood in the oral toxicity study a female and a male cat. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9415d0e-48d1-451b-8b01-6437e7182689/documents/IUC5-1d1891fa-ef6c-443d-82ae-eaaf74a8d4c3_e00b70af-35b7-452d-936e-06270e28e34d.html,,,,,, 3-aminobenzenesulphonic acid,121-47-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9415d0e-48d1-451b-8b01-6437e7182689/documents/IUC5-1d1891fa-ef6c-443d-82ae-eaaf74a8d4c3_e00b70af-35b7-452d-936e-06270e28e34d.html,,oral,,"> 5,000 mg/kg bw",no adverse effect observed, "3-aminomethyl-3,5,5-trimethylcyclohexan-1-ol",15647-11-7,"The test substance is of low oral acute toxicity with an oral LD50 ( rat) of > 2000 mg/kg bw (Reprotox 1980). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study was conducted in equivalent to OECD 401, is well documented, meets generally accepted scientific principles and is acceptable for assessment. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb5ab2e7-47d0-403e-8ecf-16343b5ca528/documents/19f870f0-0899-4571-9a34-d2b65aeda69b_9d78e554-dd00-414c-ab68-424caebecb33.html,,,,,, "3-aminomethyl-3,5,5-trimethylcyclohexan-1-ol",15647-11-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb5ab2e7-47d0-403e-8ecf-16343b5ca528/documents/19f870f0-0899-4571-9a34-d2b65aeda69b_9d78e554-dd00-414c-ab68-424caebecb33.html,,oral,LD50,"2,142 mg/kg bw",adverse effect observed, "3-amino-N,N-dimethylpropan-1-aminium 2-C10-13-alkyl benzenesulfonate",1093628-27-3," There is an Oral (Gavage) Combined Repeat Dose Toxicity Study with Reproduction/Developmental Toxicity Screening Test in the Rat (OECD442) with the test material Benzenesulfonic acid, mom-C10-13-alkylderivs., compds with N1,N1-dimethyl-1,3-rpopanediamine. The test material was a 60% solution in propylene glycol. The study was to the current OECD422 Guidelines in 2016 and was carried out with full GLP compliance. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d79f95ac-bf82-4409-9ae9-b299d747b32f/documents/a782918b-4272-4094-a90b-1c8f65419ee2_a1c0cf1c-0945-433a-9f13-06424e685063.html,,,,,, "3-amino-N,N-dimethylpropan-1-aminium 2-C10-13-alkyl benzenesulfonate",1093628-27-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d79f95ac-bf82-4409-9ae9-b299d747b32f/documents/a782918b-4272-4094-a90b-1c8f65419ee2_a1c0cf1c-0945-433a-9f13-06424e685063.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "3-amino-N,N-dimethylpropan-1-aminium 2-C10-13-alkyl benzenesulfonate",1093628-27-3," There are good quality GLP Guidelines studies for acute toxicity by the oral and dermal routes. The dermal routee being the most likely route of exposure during the manufacture and use of the substance. Acute oral toxicity, the LD50 in rats is greater than 300mg/kg bodyweight and less than 2000mg/kg bodyweight. This is CLP(GHS) Category 4. Acute dermal toxicity, the dermal LD50 in rats is greater than 2000mg/kg bodyweight. In the absence of any indication of toxicity this is considered to not meet any CLP or GHS criteria for classification for acute dermal toxicity. Acute inhalation toxicity, the test substance is manufactured and sold as a solution in 2-ethylhexanol, inhalation exposure is not expected to be a normal route of exposure. Therefore acute inhalation testing has not be performed, the study is waived as not scientifically justified. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d79f95ac-bf82-4409-9ae9-b299d747b32f/documents/ff394104-12a7-40f6-9820-0e3836825d1d_a1c0cf1c-0945-433a-9f13-06424e685063.html,,,,,, "3-amino-N,N-dimethylpropan-1-aminium 2-C10-13-alkyl benzenesulfonate",1093628-27-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d79f95ac-bf82-4409-9ae9-b299d747b32f/documents/ff394104-12a7-40f6-9820-0e3836825d1d_a1c0cf1c-0945-433a-9f13-06424e685063.html,,oral,LD50,300 mg/kg bw,adverse effect observed, 3-Aminooctan-4-ol,1001354-72-8,28-day repeat dose oral gavage study in rats14-day repeat dose dermal toxicity study in rats90-day repeat dose oral gavage study ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78e2a433-f359-4723-be92-88e9e1ccc6b2/documents/IUC5-dade02c8-d728-47eb-a342-6ea4fb5f04b4_4255d2e2-4f81-439c-bd61-b99f4a5325fa.html,,,,,, 3-Aminooctan-4-ol,1001354-72-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78e2a433-f359-4723-be92-88e9e1ccc6b2/documents/IUC5-dade02c8-d728-47eb-a342-6ea4fb5f04b4_4255d2e2-4f81-439c-bd61-b99f4a5325fa.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,,rat 3-Aminooctan-4-ol,1001354-72-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78e2a433-f359-4723-be92-88e9e1ccc6b2/documents/IUC5-dade02c8-d728-47eb-a342-6ea4fb5f04b4_4255d2e2-4f81-439c-bd61-b99f4a5325fa.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat 3-Aminooctan-4-ol,1001354-72-8,Acute oral toxicity study in the rat ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78e2a433-f359-4723-be92-88e9e1ccc6b2/documents/IUC5-6c2429cb-8fd0-4260-bb04-33ac4a5910b1_4255d2e2-4f81-439c-bd61-b99f4a5325fa.html,,,,,, 3-Aminooctan-4-ol,1001354-72-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78e2a433-f359-4723-be92-88e9e1ccc6b2/documents/IUC5-6c2429cb-8fd0-4260-bb04-33ac4a5910b1_4255d2e2-4f81-439c-bd61-b99f4a5325fa.html,,oral,LD50,550 mg/kg bw,adverse effect observed, 3-aminopropan-1-ol,156-87-6,"oral: rat, similar to OECD 401, non-GLP, LD50 = 1348 mg/kg bw, K1 (BASF, 1979) dermal: rat, no guideline followed, non-GLP, discriminating dose > 2000 mg/kg bw, K2 (BASF, 1979) inhalative: rat, no guideline followed, non-GLP, discriminating conc. > 16.4 mg/l, K2 (BASF, 1979) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c0eee30-6d95-464f-9d39-2a10dfbdbcf2/documents/IUC5-f0f2424c-6a1d-47e8-9997-e411bb46ad88_1c73eab6-6c82-41d4-8052-4a25a8c6a767.html,,,,,, 3-aminopropan-1-ol,156-87-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c0eee30-6d95-464f-9d39-2a10dfbdbcf2/documents/IUC5-f0f2424c-6a1d-47e8-9997-e411bb46ad88_1c73eab6-6c82-41d4-8052-4a25a8c6a767.html,,oral,LD50,"1,348 mg/kg bw",adverse effect observed, 3-aminopropan-1-ol,156-87-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c0eee30-6d95-464f-9d39-2a10dfbdbcf2/documents/IUC5-f0f2424c-6a1d-47e8-9997-e411bb46ad88_1c73eab6-6c82-41d4-8052-4a25a8c6a767.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-aminopropan-1-ol,156-87-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c0eee30-6d95-464f-9d39-2a10dfbdbcf2/documents/IUC5-f0f2424c-6a1d-47e8-9997-e411bb46ad88_1c73eab6-6c82-41d4-8052-4a25a8c6a767.html,,inhalation,discriminating conc.,"16,400 mg/m3",no adverse effect observed, 3-aminopropyldiethylamine,104-78-9,"Based on the results of the 90-day (OECD 408) study, a NOAEL was set at 250 mg/kg bw.   OECD 408 study The potential toxicity of Diethylaminopropylamine (as pH-neutralized dose formulations) was evaluated following daily oral administration (gavage) to rats for 13 weeks (Papineau, 2016a). On completion of the treatment period, designated animals were held for a 6-week treatment-free period in order to evaluate the reversibility of any findings. This GLP study was carried out according to OECD test guideline No. 408 (21 September 1998). Sprague-Dawley rats were treated daily by the oral route (gavage) with the test item, Diethylaminopropylamine, for 13 weeks as follows: one group of 15 males and 15 females at the dose-level of 750 mg/kg/day (group 4) and two other groups of 10 males and 10 females at dose-levels of 50 (group 2) or 250 (group 3) mg/kg/day. One group of 15 males and 15 females received the vehicle only (drinking water treated by reverse osmosis) under the same experimental conditions, and acted as a control group (group 1). A constant dosage volume of 5 mL/kg/day was used. At the end of the treatment period, the animals were sacrificed, except for the first five group 1 and 4 animals per sex, which were kept for a 6-week treatment-free period. The actual test item concentrations in the dose formulations prepared for use in Weeks 1, 4, 8 and 13 were determined using a gas chromatography with flame ionization detection analytical method. The animals were checked daily for mortality and clinical signs. Detailed clinical examinations were performed weekly and a Functional Observation Battery (FOB) was conducted in Week 13. Body weight was recorded pre-test, on the first day of treatment and then once a week. Food consumption was recorded weekly. Ophthalmological examinations were performed on all animals before the beginning of the study and on control and test item-treated animals at the end of the treatment period (Week 13). Hematology, blood biochemistry and urinary investigations were performed at the end of the treatment and treatment-free periods (Weeks 13 and 20). Additional blood samples were collected in Weeks 13 and 20 for possible analysis of thyroid hormones levels. The estrous cycle was determined for all females over 21 or 5 consecutive days at the end of the treatment or treatment-free period, respectively. Seminology investigations (count, motility and morphology) were performed on all males at sacrifice at the end of the treatment period. On completion of the treatment or treatment-free period, the animals were sacrificed and a full macroscopic post-mortem examination was performed. Designated organs were weighed and selected tissues were preserved. A microscopic examination (including testicular staging) was performed on designated tissues from control and high-dose animals sacrificed at the end of the treatment period and from animals that died prematurely and on all macroscopic lesions from all low- and intermediate-dose animals (groups 2 and 3) sacrificed on completion of the treatment period. PAS staining in the uterus in one high-dose female and immunohistochemistry for vasopressin in the pituitary gland on one control male and two high-dose males and females were examined. The brain, forestomach, gut-associated lymphoid tissue, kidneys, mesenteric lymph nodes (males only), pituitary gland, spleen and thymus of the low- and intermediate-dose animals (groups 2 and 3) sacrificed at the end of the treatment period and of the control and high-dose animals (groups 1 and 4) sacrificed at the end of the treatment-free period were also microscopically examined as changes were revealed in these organs at the end of the treatment period. Actual concentrations of Diethylaminopropylamine in the dose formulations administered to the animals during the study remained within an acceptable range (-6.5% to +9.2%) compared to the nominal concentrations. During the treatment period, three females given 750 mg/kg/day showed clinical signs which were considered to be adverse (i.e. hunched posture, dyspnea, abdominal, loud breathing and/or bent head). Hunched posture and piloerection were transiently noted in one female given 50 mg/kg/day. Ptyalism was observed with a dose-related incidence at 250 and 750 mg/kg/day and reflux at dosing was noted in few males and females given 750 mg/kg/day on one occasion. These signs commonly observed when a test item is administered by gavage, were considered not to be an adverse effect. One female given 750 mg/kg/day more severely affected, showed signs of poor clinical condition and therefore was sacrificed in Week 11. Microscopic findings were noted (i.e. vacuoles in the pars nervosa of the pituitary gland, in the renal tubules, in the white matter from the brain, in the choroid plexus, in the spleen and in the GALT). At Functional Observation Battery examination, slightly higher incidences of horizontal movements and rearing were recorded in males and females given 750 mg/kg/day. Body weight gain was slightly lower in males given 750 mg/kg/day during the first and the third months of the treatment period, leading to a slightly lower body weight on completion of the treatment period (-6% vs. controls). Food consumption was not affected by the test item treatment. No ophthalmology findings were observed at the end of the treatment period. Estrous cycle was not altered by the test item treatment. The epididymal sperm motility and morphology and the spermatozoa count were unaffected by the test item treatment. At hematology investigations, minimally to slightly lower hemoglobin concentration and packed cell volume were noted in males from 250 mg/kg/day as well as lower red blood cell count in males given 750 mg/kg/day. This was accompanied with slight increase in reticulocyte count at 750 mg/kg/day. There were also non-adverse lower eosinophil count and prolonged prothrombin time in males and females treated at 750 mg/kg/day. These variations were considered to be of minor toxicological importance. At blood biochemistry investigations, changes in the markers of the renal function (lower sodium and chloride levels, higher inorganic phosphorus levels and lower protein and/or albumin levels) observed in males and/or females from 250 mg/kg/day could be secondary to the electrolytes imbalance induced by the intake of chloride ions used to neutralize the test item. A minimal increase of higher aspartate aminotransferase and alanine aminotransferase activity was observed in males and females given 750 mg/kg/day. All these changes were considered to be of minor importance. At urinary investigations, hematuria in males and females given 750 mg/kg/day along with glucosuria in males were suggestive of a tubular resorption problem. Reversibility of these laboratory findings was noted at the end of the treatment-free period. At the end of the treatment period, microscopic vacuoles were seen in the kidneys (correlated with tan discoloration), brain (in choroid plexus), pars nervosa (pituitary gland), spleen, mesenteric lymph node and/or GALT in males and females treated at 750 mg/kg/day and at a lesser extent, at 250 mg/kg/day in isolated females. There was also a non-adverse orthokeratotic hyperkeratosis in the forestomach from males and females treated at 750 mg/kg/day and increased severity and incidence of lymphoid atrophy in the thymus from males and surviving females treated at 750 mg/kg/day which correlated with small thymus and lower weights and may be related in part with stress.   Under the experimental conditions of the study, clinical signs of poor condition were observed at the dose-level of 750 mg/kg/day in four females, which induced the premature sacrifice of one of them more severely affected. No other adverse effects were observed in the study. Consequently, the NOAEL (No Observed Adverse Effect Level) was established at 750 mg/kg/day in males and 250 mg/kg/day in females.   14-day range-finding study The potential toxicity of the test item, diethylaminopropylamine (as pH-neutralized dose formulations), was evaluated following daily oral administration (gavage) to rats for 2 weeks in order to assist the selection of dose-levels for a further OECD 408 study to be performed in the same species (Papineau, 2016b). Three groups of five male and five female Sprague-Dawley rats received the test item, by daily oral administration (gavage) for 14 days, at dose-levels of 100, 300 or 1000 mg/kg/day. The test item was administered as a solution in the vehicle (drinking water treated by reverse osmosis) at a constant dosage-volume of 5 mL/kg/day. The pH of the dosing solutions was adjusted to 8.0 (± 0.5) using a solution of hydrochloric acid. A control group of five males and five females received the vehicle alone under the same experimental conditions. Clinical signs and mortality were checked daily. Body weight was recorded once before the beginning of the treatment period, and then twice a week. Food consumption was recorded twice a week. On completion of the treatment period, the animals were euthanized and a full macroscopic post-mortem examination was performed. Designated tissues were weighed and preserved in 10% buffered formalin. A microscopic examination was performed on macroscopic lesions for all animals and on stomach with forestomach for the control and high-dose animals. No unscheduled deaths occurred during the study. Ptyalism, not considered as an adverse sign of toxicity, was observed at 1000 mg/kg/day (1/5 males and 4/5 females). Lower body weight gain was observed at 1000 mg/kg/day in males and females over the first 3 days of the study together with slight lower food consumption. This effect was present in a lesser extent in males throughout the study and resulted in a lower final body weight. No macroscopic findings were attributed to treatment with the test item. Slight hyperplasia of squamous cells associated with minimal to slight hyperkeratosis was observed at 1000 mg/kg/day in the forestomach of 5/5 males and 4/5 females and was considered to be non-adverse. No treatment-related effects were observed at 100 and 300 mg/kg/day.   -Maximum tolerated dose in rabbits (Charles River, 2020): Under the experimental conditions of the study, the dose level of 1000 mg/kg/day given orally (gavage) was considered to have exceeded the MTD in New Zealand White female rabbits (premature euthanasia after 4 days of dosing, clinical signs of poor health in 1/3 females, body weight loss, no food consumption). There were no adverse effects up to 300 mg/kg/day based on were limited to a transient body weight loss and reduction of food consumption at 300 mg/kg/day and no effet at 100 mg/kg/day . Therefore and under the experimental condition of this study, the MTD was considered to be within the [300; 1000] mg/kg/day interval.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP guideline study ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/066b5e32-1f53-4219-8178-fab160ef6833/documents/IUC5-44a17c25-cd6d-48f7-a1ce-8052e14e78e7_c3020ff1-f4e1-4916-bd0d-b760755a385a.html,,,,,, 3-aminopropyldiethylamine,104-78-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/066b5e32-1f53-4219-8178-fab160ef6833/documents/IUC5-44a17c25-cd6d-48f7-a1ce-8052e14e78e7_c3020ff1-f4e1-4916-bd0d-b760755a385a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 3-aminopropyldiethylamine,104-78-9," In a study performed according to a protocol comparable to the OECD Guideline 401, the oral LD50 was 830 mg/kg bw in rat. In an acute dermal toxicity study performed according the OECD guideline #402, the dermal LD50 was 0.64 (0.39-1.04)ml/kg(524 mg/kg)in male New Zealand rabbit. In a inhalation risk test, no mortality was observed after a 4h-exposure to saturated vapours.   Oral toxicity In a key study comparable to the OECD no. 401 Guideline (BASF AG, 1981), test groups of 5 or 10 rats were treated by single gavage application with an aqueous solution of 3-aminopropyldiethylamine. The animals were observed for mortality and for clinical symptoms of toxicity. They were weighed prior treatment and thereafter, day 3, day 7 and day 13 post-treatment. At the end of the observation period of 14 days, the surviving animals were sacrificed for the purpose of necropsy; animals that died during the observations period also were subjected to necropsy. The LD50 value was estimated to be ca. 830 mg/kg on the basis of the observed mortalities. The acute oral toxicity of 3-aminopropyldiethylamine (DEAPA) was evaluated in rats according to a protocol similar to OECD no. 401 guideline (Myers and Ballantine, 1997). Groups of 5 male Wistar albino rats were given a single oral dose of DEAPA. Following treatment, rats were observed daily. Animals were weighted before treatment and 14 days after dosing, time of scheduled euthanasia. No other data is available but under these experimental conditions, the oral LD50 of DEAPA is 0.50 ml/kg (0.26-0.76 ml/kg) or 410 mg/kg (213 -623) in Wistar rats with 95% confidence interval limits. The acute oral toxicity of 3-aminopropyldiethylamine (DEAPA) was evaluated in groups of five male Carworth-Wistar rats (Smyth et al., 1962). No precise data are available, but under these experimental conditions, the oral LD50 of DEAPA is 1410 mg/kg (1210-1650mg/kg) in male rats with 95% confidence interval limits.   Inhalation toxicity Data were available from an inhalation risk test (IRT) which meets generally accepted scientific principles (BASF AG, 1961). The toxicity of an atmosphere saturated with vapours of the volatile components of 3-aminopropyldiethylamine at the temperature chosen for vapour generation (20 °C) was evaluated in 3 or 6 rats per sex exposed sequentially to the vapours, generated by bubbling 200 l/h air through a substance column of about 5 cm above a fritted glass disc in a glass cylinder for 30 min, 2 h and 8h. The documentation of clinical signs was performed over a period of 7 days. No mortality was observed after a 30-min exposure. One female died within 24 h after a 2h-exposure and 1 male and 2 females died within 24 h after a 8h-exposure. In 2 other IRT (Myers and Ballantyne, 1997; Smyth et al., 1962), the inhalation of a saturated vapor-air mixture for 4 or 8 hours caused no mortality.   Dermal toxicity The acute dermal toxicity of 3-aminopropyldiethylamine was evaluated in five male New Zealand white rabbits (Myers and Ballantyne, 1997). The test substance was applied under an impervious plastic sheeting wrapped around the trunk and secured. The rabbit was then immobilized into a restraining apparatus for 24 hours. Animals were observed during 14 days. No other data is available. Under these experimental conditions, the dermal LD50 was 0.64 ml/kg (524 mg/kg) in male rabbits. The acute dermal toxicity of 3-aminopropyldiethylamine (DEAPA) was evaluated in groups of four white New-Zealand rabbits (Smyth et al., 1962). No precise data are available, but under these experimental conditions, the LD50 was 0.75 ml/kg (615 mg/kg). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/066b5e32-1f53-4219-8178-fab160ef6833/documents/IUC5-228af5f5-4636-4400-9e2a-4fe47b0adde5_c3020ff1-f4e1-4916-bd0d-b760755a385a.html,,,,,, 3-aminopropyldiethylamine,104-78-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/066b5e32-1f53-4219-8178-fab160ef6833/documents/IUC5-228af5f5-4636-4400-9e2a-4fe47b0adde5_c3020ff1-f4e1-4916-bd0d-b760755a385a.html,,oral,LD50,830 mg/kg bw,adverse effect observed, 3-aminopropyldiethylamine,104-78-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/066b5e32-1f53-4219-8178-fab160ef6833/documents/IUC5-228af5f5-4636-4400-9e2a-4fe47b0adde5_c3020ff1-f4e1-4916-bd0d-b760755a385a.html,,dermal,LD50,524 mg/kg bw,adverse effect observed, Famoxadone,131807-57-3,"90-Day rat feeding study NOAEL: 50 ppm (3.34 mg/kg bw) for males and 50 ppm (4.24 mg/kg bw) in females; OECD 408, OPP-82-1, JMAFF 59-NohSan-4200; Reliability = 1 90-Day mouse feeding study NOAEL: 350 ppm (equivalent to 62.4 and 79.7 mg/kg bw in males and females respectively); OECD 408, OPP-82-1, JMAFF 59-NohSan-4200; Reliability = 1 90-Day dog feeding study LOAEL (females): 40 ppm (1.4 mg/kg bw), NOAEL (males): 40 ppm (1.3 mg/kg bw); OECD 409, OPP 82-1, JMAFF 59-NohSan-4200; Reliability = 1 1-Year dog feeding study NOAEL: 40 ppm (equivalent to 1.2 mg/kg/day in both male and females); OECD 452, OPP 83-1, JMAFF 59-NohSan-4200; Reliability = 1 1-Year monkey gavage study NOAEL 100 mg/kg/day, not a guideline study, Reliability = 2 28-Day rat inhalation study NOAEC: 15 mg/m³;  EPA OPPTS 870.3465; Reliability = 1 28-Day rat dermal study NOAEL: 250 mg/kg/day for males and females; OECD 410, EU Method B.9, OPP 82-2, JMAFF 59-NohSan-4200; Reliability = 1 Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): One 28-day dermal study was available in rats. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): A 5-day range-finder study and a 28-day inhalation study were available in rats. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 90-day guideline studies for were available in rat, mice and dogs. In addition a 1-year guideline study was available in dogs, a non-guideline 1-year study was available in monkeys, and a 2-year guideline study was available in rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e30a4202-7146-4a53-a618-b7b44d710f01/documents/1f2adcc4-47b2-4381-9f85-947867d928a9_5728b076-ba0e-4fe9-b3ec-3c9f6a81759d.html,,,,,, Famoxadone,131807-57-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e30a4202-7146-4a53-a618-b7b44d710f01/documents/1f2adcc4-47b2-4381-9f85-947867d928a9_5728b076-ba0e-4fe9-b3ec-3c9f6a81759d.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,250 mg/kg bw/day,,rat Famoxadone,131807-57-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e30a4202-7146-4a53-a618-b7b44d710f01/documents/1f2adcc4-47b2-4381-9f85-947867d928a9_5728b076-ba0e-4fe9-b3ec-3c9f6a81759d.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,15 mg/m3,,rat Famoxadone,131807-57-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e30a4202-7146-4a53-a618-b7b44d710f01/documents/1f2adcc4-47b2-4381-9f85-947867d928a9_5728b076-ba0e-4fe9-b3ec-3c9f6a81759d.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,1.4 mg/kg bw/day,,dog Famoxadone,131807-57-3,"Oral LD50 (Female rat): >5000 mg/kg; OECD 425 and OPPTS 870.1100; Reliability = 1 Oral LD50 (Male/Female Rat): >5000 mg/kg; OECD 401, EU Method B.1, OPP 81-1, JMAFF 59-HohSan-4200; Reliability = 1 Oral LD50 (Male/Female mice): >5000 mg/kg; OECD 401, EU Method B.1, OPP 81-1, JMAFF 59-HohSan-4200; Reliability = 1 Dermal LD50 (Rat): >5000 mg/kg; OECD 402, EU Method B.3, OPPTS 870.1200 and JMAFF 12-Nousan-8147; Reliability = 1 Dermal LD50 (Rabbit): >2000 mg/kg; OECD 402, EU Method B.3, OPP 81-2 and JMAFF 59-NohSan-4200; Reliability = 1 Inhalation LC50 (Rat): >5.3 mg/L; OECD 403, EU Method B.2, OPP 81-3 and JMAFF 59-NohSan-4200; Reliability = 1 Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Three guideline studies were available for the acute oral route, two in the rat and one in the mouse. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): One guideline inhalation study was available in the rat. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Two guideline dermal LD50 studies were available, one in the rat and one in the rabbit. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e30a4202-7146-4a53-a618-b7b44d710f01/documents/9d391362-7120-4234-8700-b5d3aa375787_5728b076-ba0e-4fe9-b3ec-3c9f6a81759d.html,,,,,, Famoxadone,131807-57-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e30a4202-7146-4a53-a618-b7b44d710f01/documents/9d391362-7120-4234-8700-b5d3aa375787_5728b076-ba0e-4fe9-b3ec-3c9f6a81759d.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Famoxadone,131807-57-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e30a4202-7146-4a53-a618-b7b44d710f01/documents/9d391362-7120-4234-8700-b5d3aa375787_5728b076-ba0e-4fe9-b3ec-3c9f6a81759d.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Famoxadone,131807-57-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e30a4202-7146-4a53-a618-b7b44d710f01/documents/9d391362-7120-4234-8700-b5d3aa375787_5728b076-ba0e-4fe9-b3ec-3c9f6a81759d.html,,inhalation,LC50,> 5.3 mg/L,no adverse effect observed, 3-bromoanisole,2398-37-0, LD50 was estimated to be 3542.6 mg/kg bw when rats were orally exposed with 1-bromo-3-methoxybenzene ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9538e3a1-c97c-47df-aeb0-97458cf578ea/documents/c575ea63-d4cd-4809-8b5f-db517c7470a4_67008d3e-faec-4731-adb5-630730ba4369.html,,,,,, 3-bromoanisole,2398-37-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9538e3a1-c97c-47df-aeb0-97458cf578ea/documents/c575ea63-d4cd-4809-8b5f-db517c7470a4_67008d3e-faec-4731-adb5-630730ba4369.html,,oral,LD50,"3,542.6 mg/kg bw",no adverse effect observed, 3-bromoquinoline,5332-24-1," Acute oral toxicity:  LD50 was estimated to be 2921 mg/kg bw, when Tif: RAIf (SPF) male and female rats were treated with 3-Bromoquinoline orally by intubation. Acute Dermal toxicity:  LD50 was estimated to be 2957 mg/kg bw, when New Zealand White male and female rabbits were treated with 3-Bromoquinoline by dermal application occlusively. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b616fd93-a6fd-4eff-9d99-7e48a0077f5a/documents/62c0070b-ef98-4535-9fad-0ed94bedbac5_f12890f8-1676-4ade-b2e1-160395d17026.html,,,,,, 3-bromoquinoline,5332-24-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b616fd93-a6fd-4eff-9d99-7e48a0077f5a/documents/62c0070b-ef98-4535-9fad-0ed94bedbac5_f12890f8-1676-4ade-b2e1-160395d17026.html,,oral,LD50,"2,921 mg/kg bw",no adverse effect observed, 3-bromoquinoline,5332-24-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b616fd93-a6fd-4eff-9d99-7e48a0077f5a/documents/62c0070b-ef98-4535-9fad-0ed94bedbac5_f12890f8-1676-4ade-b2e1-160395d17026.html,,dermal,LD50,"2,957 mg/kg bw",no adverse effect observed, "3-Butoxy-7-ethoxy-4,6-difluoro-dibenzothiophene",1818916-02-7, GLP compliant OECD 423: LD50 (oral) > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0c92be3-d0c9-48eb-8fa2-987a5c98130c/documents/d3a77a06-3a7c-4a9e-ae4e-d686d4c9434f_bffb26c4-ca14-4142-9c9c-de8c0db91a6d.html,,,,,, "3-Butoxy-7-ethoxy-4,6-difluoro-dibenzothiophene",1818916-02-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0c92be3-d0c9-48eb-8fa2-987a5c98130c/documents/d3a77a06-3a7c-4a9e-ae4e-d686d4c9434f_bffb26c4-ca14-4142-9c9c-de8c0db91a6d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 3-butoxypropylamine,16499-88-0," Repeated dose toxicity - oral: A key K1 study in male and female Wistar rats in a combined repeated dose toxicity test with reproductive/developmental screening was conducted according to OECD guideline 422 (Edwards, 2018). The NOAEL is established to be 90 mg/kg body weight/day. Repeated dose toxicity - dermal or inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation or dermal route of exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e1f7f2e-f8d6-4cbc-b015-47a6a80821d6/documents/f4d1b870-d217-4339-830f-ee4b368cdd4e_d4197434-9542-4c64-a37f-bb5a68b442c6.html,,,,,, 3-butoxypropylamine,16499-88-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e1f7f2e-f8d6-4cbc-b015-47a6a80821d6/documents/f4d1b870-d217-4339-830f-ee4b368cdd4e_d4197434-9542-4c64-a37f-bb5a68b442c6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,90 mg/kg bw/day,,rat 3-butoxypropylamine,16499-88-0," Acute toxicity: Oral In an acute oral toxicity study in female rats, following the acute toxic class method in accordance with the OECD Guideline 425, the LD50 was established to be 175 mg/kg (Lemoncelli, 2014). Acute toxicity: Inhalation In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For this substance, the Regulation states that the study does not need to be conducted if the substance is classified as skin corrosive. Therefore, an acute inhalation toxicity study should not be performed. Acute toxicity: Dermal In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For this substance, the Regulation states that the study does not need to be conducted if the substance is classified as skin corrosive. Therefore, an acute dermal toxicity study should not be performed. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e1f7f2e-f8d6-4cbc-b015-47a6a80821d6/documents/16cfba9e-6e8d-44b1-8814-c66f4d00ccd9_d4197434-9542-4c64-a37f-bb5a68b442c6.html,,,,,, 3-butoxypropylamine,16499-88-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e1f7f2e-f8d6-4cbc-b015-47a6a80821d6/documents/16cfba9e-6e8d-44b1-8814-c66f4d00ccd9_d4197434-9542-4c64-a37f-bb5a68b442c6.html,,oral,LD50,175 mg/kg bw,adverse effect observed, 3-chloroaniline,108-42-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Test method not reported. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Test method not reported. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Test method not reported. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9fa86ee-bbbf-44eb-89ce-768c3a0218e3/documents/IUC5-3c3de734-db6a-4c57-b29a-9d7b4bc552b3_4a26e733-67d7-4afa-a4dd-946c39aa2aa5.html,,,,,, 3-chloroaniline,108-42-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9fa86ee-bbbf-44eb-89ce-768c3a0218e3/documents/IUC5-3c3de734-db6a-4c57-b29a-9d7b4bc552b3_4a26e733-67d7-4afa-a4dd-946c39aa2aa5.html,,oral,LD50,256 mg/kg bw,adverse effect observed, 3-chloroaniline,108-42-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9fa86ee-bbbf-44eb-89ce-768c3a0218e3/documents/IUC5-3c3de734-db6a-4c57-b29a-9d7b4bc552b3_4a26e733-67d7-4afa-a4dd-946c39aa2aa5.html,,dermal,LD50,250 mg/kg bw,adverse effect observed, 3-chloroaniline,108-42-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9fa86ee-bbbf-44eb-89ce-768c3a0218e3/documents/IUC5-3c3de734-db6a-4c57-b29a-9d7b4bc552b3_4a26e733-67d7-4afa-a4dd-946c39aa2aa5.html,,inhalation,LC50,550 mg/m3,adverse effect observed, 3-chloroperbenzoic acid,937-14-4," The potential toxic effects of the substance when given orally by gavage for a minimum of 28 days to Wistar Han rats was determined employing the combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test.The dose levels in this study were 0, 15, 50 and 150 mg/kg/day, based on the results of the dose range finder.No parental toxicity was observed up to the highest dose level tested (150 mg/kg). A few non-adverse changes were noted at 50 and/or 150 mg/kg and consisted of slight salivation after dosing at 50 and 150 mg/kg (in a dose-related manner), regarded as a physiological response related to the irritant properties of the substance rather than a sign of systemic toxicity, and a gelatinous thyroid gland at 150 mg/kg in 2/10 females. This macroscopic finding was not associated with histopathological alterations in the thyroid gland. Based on the results of this combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the No Observed Adverse Effect Level (NOAEL) of the substance is 150 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8763e201-360d-4784-ae6b-b070a676f7f0/documents/068f4062-cf7e-4008-98d3-872a0e6f6132_da4b8d9b-0d84-44c4-be82-ad5e6dc10725.html,,,,,, 3-chloroperbenzoic acid,937-14-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8763e201-360d-4784-ae6b-b070a676f7f0/documents/068f4062-cf7e-4008-98d3-872a0e6f6132_da4b8d9b-0d84-44c4-be82-ad5e6dc10725.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat 3-chloroperbenzoic acid,937-14-4, In an acute toxicity study the substance was administered to Wistar rats (5 animals/sex/dose) by oral gavage at a dose level of up to 2500 mg/kg bw (single administration). The oral LD50 is calculated to be 1807 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8763e201-360d-4784-ae6b-b070a676f7f0/documents/a7e0c626-fc4e-4db7-b21c-b092b5961046_da4b8d9b-0d84-44c4-be82-ad5e6dc10725.html,,,,,, 3-chloroperbenzoic acid,937-14-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8763e201-360d-4784-ae6b-b070a676f7f0/documents/a7e0c626-fc4e-4db7-b21c-b092b5961046_da4b8d9b-0d84-44c4-be82-ad5e6dc10725.html,,oral,LD50,"1,807 mg/kg bw",adverse effect observed, 3-chlorophenyl isocyanate,2909-38-8,No reliable data available. ,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e325803-0727-4e92-a4fe-94585a87cbae/documents/IUC5-8c3a3bda-adbc-4204-8f00-3826c0bfc4e0_2f760092-4175-43eb-b7e3-6d0eae564926.html,,,,,, 3-chlorophenyl isocyanate,2909-38-8,"Acut oral: LD50 rat; male: 2.61 ml/kg bw (Löser, 1981); Acut inhalation: LC 50 rat; male female: 42 mg/m³ air (LC 50 male: 58 mg/m³air; LC 50 female: 39 mg/m³) (Pauluhn, 1991). Acut dermal: LD50 rat, male: >2.5 ml/kg (Löser, 1982). ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e325803-0727-4e92-a4fe-94585a87cbae/documents/IUC5-5838c5c6-8cae-449b-b54a-dcb9e7131025_2f760092-4175-43eb-b7e3-6d0eae564926.html,,,,,, "3-chloropropane-1,2-diol",96-24-2,"Acute oral toxicity:Numerous studies are present in public literature that describe the effects after a single oral exposure. However most of these studies use sublethal dosages to assess the antifertility effects and the underlying mechanisms. A few studies are conducted to assess the LD50 value: Kennelly et al. (1970) and Hine et al. (1956). Acute inhalation toxicity:Three studies are available, one GLP guideline study (TNO, 1992), the Carpenter et al. publication (1949) and the Hine et al. publication (1956).Acute dermal toxicity: no information available. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/267f703f-f91e-4437-ae50-fe6129bf62d0/documents/IUC5-983ed74b-dca9-413f-b5e8-9b83e3772e94_343e3b38-4c8c-4f7c-b54d-4b40183113ef.html,,,,,, "3-chloropropane-1,2-diol",96-24-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/267f703f-f91e-4437-ae50-fe6129bf62d0/documents/IUC5-983ed74b-dca9-413f-b5e8-9b83e3772e94_343e3b38-4c8c-4f7c-b54d-4b40183113ef.html,,oral,LD50,150 mg/kg bw,, 3-chloropropionic acid,107-94-8,"According to Column 2 of Annex VII, the oral acute toxicity study does not need to be conducted if the substance is classified as corrosive to the skin. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42c6f641-8b34-4020-a61c-dad28657e5ad/documents/IUC5-20d04c40-50e7-4d39-acaa-2635e0b7663a_907522b1-e5f6-4e84-8783-4561fd0bc0cf.html,,,,,, 3-chloropropionyl chloride,625-36-5, In an acute oral toxicty study (similar to OECD 401) a LD50 between 1000 and 1470 mg/kg bw was derived. In an acute inhalation toxicity study a LC50 <0.90 mg/L/1h air was derived. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aacbfa52-ad4d-4624-9338-39b7811cc82a/documents/IUC5-d7851e32-86a5-4074-a319-c52c275e2389_bc0f17d2-7b9d-49a4-893f-2db009f25d00.html,,,,,, 3-chloropropionyl chloride,625-36-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aacbfa52-ad4d-4624-9338-39b7811cc82a/documents/IUC5-d7851e32-86a5-4074-a319-c52c275e2389_bc0f17d2-7b9d-49a4-893f-2db009f25d00.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, 3-chloro-p-toluidine,95-74-9," Several acute oral studies are available. In the most reliable study (Kimmerle, 1972), a LD50 (rat) of 1053 mg/kg bw was found. In the acute inhalation study, a LC50(rat) > 7.69 mg/L was detected (maximal examined concentration). The acute dermal LD50 (rat) (4 hours exposure) was 650 µl 3-chloro-p-toluidine/kg bw (= ca. 765 mg/kg bw). 3-chloro-p-toluidine causes methemoglobinemia. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e8f5eeb-42b8-4428-879b-3f151e80284f/documents/3ec60d54-2a39-44e6-92a1-9137ce86ee72_0602f114-b9ed-45de-b083-e51cc1cd84b6.html,,,,,, 3-chloro-p-toluidine,95-74-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e8f5eeb-42b8-4428-879b-3f151e80284f/documents/3ec60d54-2a39-44e6-92a1-9137ce86ee72_0602f114-b9ed-45de-b083-e51cc1cd84b6.html,,oral,LD50,"1,053 mg/kg bw",adverse effect observed, 3-chloro-p-toluidine,95-74-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e8f5eeb-42b8-4428-879b-3f151e80284f/documents/3ec60d54-2a39-44e6-92a1-9137ce86ee72_0602f114-b9ed-45de-b083-e51cc1cd84b6.html,,dermal,LD50,765 mg/kg bw,adverse effect observed, 3-chloro-p-toluidine,95-74-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e8f5eeb-42b8-4428-879b-3f151e80284f/documents/3ec60d54-2a39-44e6-92a1-9137ce86ee72_0602f114-b9ed-45de-b083-e51cc1cd84b6.html,,inhalation,LC50,"7,690 mg/m3",adverse effect observed, 3-chloro-p-tolyl isocyanate,28479-22-3,no valid data available ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1595d09-4f4d-4183-af46-6b2915578cc6/documents/IUC5-ded366e6-8939-4d3d-9937-780ce2f26384_dfb4191d-c9d7-4034-9ace-5a3c6956a58a.html,,,,,, 3-chloro-p-tolyl isocyanate,28479-22-3,acute oral toxicity: LD50 > 6100 mg/kg bw for rat acute inhalative toxicity: LC50 = 71 mg/L air (guideline study) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1595d09-4f4d-4183-af46-6b2915578cc6/documents/IUC5-26053511-c610-4a17-933a-c95330b3e018_dfb4191d-c9d7-4034-9ace-5a3c6956a58a.html,,,,,, 3-chloro-p-tolyl isocyanate,28479-22-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1595d09-4f4d-4183-af46-6b2915578cc6/documents/IUC5-26053511-c610-4a17-933a-c95330b3e018_dfb4191d-c9d7-4034-9ace-5a3c6956a58a.html,,oral,discriminating dose,"6,100 mg/kg bw",, 3-chloro-p-tolyl isocyanate,28479-22-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1595d09-4f4d-4183-af46-6b2915578cc6/documents/IUC5-26053511-c610-4a17-933a-c95330b3e018_dfb4191d-c9d7-4034-9ace-5a3c6956a58a.html,,inhalation,LC50,71 mg/m3,, "3-cyano-3,5,5-trimethylcyclohexanone",7027-11-4,"In a 13 week oral subcronic toxicity study with rats, the test item showed effects on central and/or motoric nervous system (hyperkinesia, hyperactivity, clonic convulsion, salivation) as well as histopathological alterations in the liver of males. The NOAEL of the test item is determined to be 8.25 mg/kg bw under the conditions of this study (Asta, 1992). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/127f4926-787e-4292-b1cc-161aeaf492ba/documents/70550f34-96cc-400d-ac00-c658368b7b3a_5f941b94-ff13-421f-b3a7-cc54c2041f69.html,,,,,, "3-cyano-3,5,5-trimethylcyclohexanone",7027-11-4,"The derived LD 50 value for acute oral toxicity is 178 mg/kg bw (Hüls, 1985). Thus, the test item is regarded and classified as toxic if swallowed. Because of a LD50 value for acute dermal toxicity of more than 2000 mg/kg b.w in rabbits (Asta, 1990), the test item showed very low dermal toxicity under conditions of the conducted study. According to the outcome of an acute inhalation study with rats (RCC, 1999; LC50 1.34 mg/l air) the test item is classfied as harmful by inhalation. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/127f4926-787e-4292-b1cc-161aeaf492ba/documents/IUC5-2cce1bf0-824a-4bee-bf2b-dbbf45f59c84_5f941b94-ff13-421f-b3a7-cc54c2041f69.html,,,,,, "3-cyano-3,5,5-trimethylcyclohexanone",7027-11-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/127f4926-787e-4292-b1cc-161aeaf492ba/documents/IUC5-2cce1bf0-824a-4bee-bf2b-dbbf45f59c84_5f941b94-ff13-421f-b3a7-cc54c2041f69.html,,oral,LD50,178 mg/kg bw,adverse effect observed, "3-cyano-3,5,5-trimethylcyclohexanone",7027-11-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/127f4926-787e-4292-b1cc-161aeaf492ba/documents/IUC5-2cce1bf0-824a-4bee-bf2b-dbbf45f59c84_5f941b94-ff13-421f-b3a7-cc54c2041f69.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-cyano-3,5,5-trimethylcyclohexanone",7027-11-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/127f4926-787e-4292-b1cc-161aeaf492ba/documents/IUC5-2cce1bf0-824a-4bee-bf2b-dbbf45f59c84_5f941b94-ff13-421f-b3a7-cc54c2041f69.html,,inhalation,LC50,"1,340 mg/m3",adverse effect observed, (1R)-1-isopropyl-4-methyl-cyclohex-3-en-1-ol,20126-76-5," Oral (similar to OECD 401), rat: LD50 calculated = 1300 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05e40e71-97a4-4823-a98a-a6dfb25d5c14/documents/056218b3-c175-4516-a48e-259c20d1e522_49e8326e-99c3-4fa0-b46d-8729d7065641.html,,,,,, (1R)-1-isopropyl-4-methyl-cyclohex-3-en-1-ol,20126-76-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05e40e71-97a4-4823-a98a-a6dfb25d5c14/documents/056218b3-c175-4516-a48e-259c20d1e522_49e8326e-99c3-4fa0-b46d-8729d7065641.html,,oral,LD50,"1,300 mg/kg bw",adverse effect observed, "3-Cyclohexene-1-methanol, α,4-dimethyl-α-(4-methyl-3-penten-1-yl)-",72691-24-8,"Repeated dose dermal toxicity (OECD 410, GLP): Wistar rats were exposed for 4 weeks to (+/-) alpha-Bisabolol at doses of 50, 200 and 1000 mg/kg bw/day. A NOAEL of 200 mg/kg bw/day has been set (BASF 1996; 33S0144/95020) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03873873-bf4f-4a8d-99cb-6d0700e17856/documents/IUC5-688cf50a-64d0-4407-adaa-14f16fcf9d1f_d909477a-0c90-46a3-bde1-0c4640460152.html,,,,,, "3-Cyclohexene-1-methanol, α,4-dimethyl-α-(4-methyl-3-penten-1-yl)-",72691-24-8,"The oral LD50 value was determined > 2000 mg/kg body weight (acc. OECD TG 423, GLP; BASF 2001; 10A0588/001113).The dermal LD50 was determined to be > 750 a.i. mg/kg bw (Symrise 1983) and > 5000 mg/kg bw (Moreno 1973) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03873873-bf4f-4a8d-99cb-6d0700e17856/documents/IUC5-4fb67c80-2cc6-4970-9664-1f4cb9a4aa2c_d909477a-0c90-46a3-bde1-0c4640460152.html,,,,,, 3-cyclohexylaminopropane-1-sulphonic acid,1135-40-6," Repeated dose toxicity: subacute (28 day) study oral (gavage), rat (Wistar) m/f (according to OECD 407, GLP): NOAEL = 50 mg/kg bw/d (males, based on haematology, clinical chemistry) NOAEL = 50 mg/kg bw/d (females, based on haematology) No specific target organ toxicity was identified, no classification as STOT RE Cat. 2 was triggered. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c271446d-ff85-44a5-80d8-eab76d81ecdf/documents/44ec17fd-c0d6-452d-a967-3571db3dcc2c_4517f534-5bc3-4555-9f02-34ce2860abda.html,,,,,, 3-cyclohexylaminopropane-1-sulphonic acid,1135-40-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c271446d-ff85-44a5-80d8-eab76d81ecdf/documents/44ec17fd-c0d6-452d-a967-3571db3dcc2c_4517f534-5bc3-4555-9f02-34ce2860abda.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 3-cyclohexylaminopropane-1-sulphonic acid,1135-40-6," Acute toxicity oral: fixed dose procedure, oral (gavage), rat (Wistar), female, 14 days postobservation: LD50 > 2000 mg/kg, LD0 ≥ 2000 mg/kg (OECD 420, GLP) Acute toxicity dermal: standard acute method, limit test, dermal (occlusive), unchanged, rat (Wistar), m/f, 14 days postobservation: LD50 > 2000 mg/kg, LD0 ≥ 2000 mg/kg, no signs of irritation observed (OECD 402, GLP) Acute toxicity inhalation: no study available, waiving out of scientific reasons and exposure considerations ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c271446d-ff85-44a5-80d8-eab76d81ecdf/documents/ab52cdd3-db77-443c-aef2-acea2244b94a_4517f534-5bc3-4555-9f02-34ce2860abda.html,,,,,, 3-cyclohexylaminopropane-1-sulphonic acid,1135-40-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c271446d-ff85-44a5-80d8-eab76d81ecdf/documents/ab52cdd3-db77-443c-aef2-acea2244b94a_4517f534-5bc3-4555-9f02-34ce2860abda.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-cyclohexylaminopropane-1-sulphonic acid,1135-40-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c271446d-ff85-44a5-80d8-eab76d81ecdf/documents/ab52cdd3-db77-443c-aef2-acea2244b94a_4517f534-5bc3-4555-9f02-34ce2860abda.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-cyclohexylaminopropylamine,3312-60-5,"The test substance is harmful if swallowed with an oral LD50 (rat) between 200 - 237 mg/kg bw/d (Abbott Labs, 1963). After single inhalation whole body exposure of young CD rats to the test compound for 60 minutes, no toxicological effects could be seen during the 14 days observation period after the exposure. Further, the compound is considered to be a severe skin irritant and possesses the ability to penetrate the skin and produce systemic toxicity and even death in the rabbit. For acute dermal toxicity the LD50 was determined to be between 632 and 2000 mg/kg bw/d. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Klimisch 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch 2 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42669e16-fcd2-4519-b06c-433a61852298/documents/184336a3-c710-44ec-8166-096d4d41d7d9_5fa218af-e7ec-45e9-87df-7ab35b88ae81.html,,,,,, "3-diazo-3,4-dihydro-4-oxonaphthalene-1-sulfonyl chloride",36451-09-9," Based on the result of this study, it is concluded that the test material has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg after single oral administration in rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb8b3922-904f-4e0d-8bdb-1ef831134dd2/documents/050bad1d-346a-4dc3-8bbd-83a89462cca0_e5918591-a6eb-453c-b2cb-2d87a11c91d7.html,,,,,, "3-diazo-3,4-dihydro-4-oxonaphthalene-1-sulfonyl chloride",36451-09-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb8b3922-904f-4e0d-8bdb-1ef831134dd2/documents/050bad1d-346a-4dc3-8bbd-83a89462cca0_e5918591-a6eb-453c-b2cb-2d87a11c91d7.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 3-dimethylaminopropan-1-ol,3179-63-3,"No repeated dose toxicity study is available for dimethylaminopropanol. Dimethylethanolamine (DMAE) is a structural analogue of dimethylaminopropanol and was used for read-across. Repeated dose toxicity (vapour inhalation): Dimethylethanolamine: Acute, 2-week and 13-week Inhalation Toxicity Studies in Rats. Comparable to the OECD guideline 413 with concentrations tested of 8, 24 and 76 ppm (equivalent to 36, 108 and 325 mg/m³). The NOEC for local effects was 108 mg/m³ and the NOAEC for systemic effects was found to be greater than 325 mg/m³. [Klonne et al., 1987] ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb200b2d-41f9-4acc-ae40-87186290ce86/documents/IUC5-0aa09dbb-a82b-44c3-b40c-b897832cb6b2_e1d17962-30c9-41ac-bb89-059ccf43b778.html,,,,,, 3-dimethylaminopropan-1-ol,3179-63-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb200b2d-41f9-4acc-ae40-87186290ce86/documents/IUC5-0aa09dbb-a82b-44c3-b40c-b897832cb6b2_e1d17962-30c9-41ac-bb89-059ccf43b778.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,325 mg/m3,,rat 3-dimethylaminopropan-1-ol,3179-63-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb200b2d-41f9-4acc-ae40-87186290ce86/documents/IUC5-0aa09dbb-a82b-44c3-b40c-b897832cb6b2_e1d17962-30c9-41ac-bb89-059ccf43b778.html,Repeated dose toxicity – local effects,inhalation,NOAEC,108 mg/m3,adverse effect observed,rat 3-dimethylaminopropan-1-ol,3179-63-3,"Acute toxicity data indicate a moderate toxicity: in rats the oral LD50 was 1860 mg/kg bw. Inhalation exposure for 1-8 hours to vapour saturated with dimethylaminopropanol (inhalation risk test) showed the potential for an acute hazard, being not sufficient for classification puposes. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb200b2d-41f9-4acc-ae40-87186290ce86/documents/IUC5-10b8b8d0-2a58-461b-a01b-9ca3f06c7001_e1d17962-30c9-41ac-bb89-059ccf43b778.html,,,,,, 3-dimethylaminopropan-1-ol,3179-63-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb200b2d-41f9-4acc-ae40-87186290ce86/documents/IUC5-10b8b8d0-2a58-461b-a01b-9ca3f06c7001_e1d17962-30c9-41ac-bb89-059ccf43b778.html,,oral,LD50,"1,860 mg/kg bw",adverse effect observed, 3-dimethylaminopropiononitrile,1738-25-6,3-dimethylaminopropionitrile cause urinary bladder And kidney damage after ingestion ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a142a4fe-9aaf-4fa6-bd42-c3cec33f3246/documents/IUC5-131bcedf-003d-4251-9160-d3c3861e376f_7334a6b5-0823-4a32-a32b-f324ed07440e.html,,,,,, 3-dimethylaminopropiononitrile,1738-25-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a142a4fe-9aaf-4fa6-bd42-c3cec33f3246/documents/IUC5-131bcedf-003d-4251-9160-d3c3861e376f_7334a6b5-0823-4a32-a32b-f324ed07440e.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,350 mg/kg bw/day,, 3-dimethylaminopropiononitrile,1738-25-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a142a4fe-9aaf-4fa6-bd42-c3cec33f3246/documents/IUC5-131bcedf-003d-4251-9160-d3c3861e376f_7334a6b5-0823-4a32-a32b-f324ed07440e.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,100 mg/m3,, 3-dimethylaminopropiononitrile,1738-25-6,"Porlonged exposure to a saturated vapor atmosphere may cause death. 3-Dimethylaminopropionitril is of moderate toxicity after inhalative, oral and dermal exposure. OralLD50 rat: 1290 mg/kg bw (comp. OECD 401; BASF 1975)InhalationIHT rat 8h: mortality 1/12 (comp. OECD 403/annex; BASF 1975)DermalLD50 rabbit: 1213 mg/kg bw (standardized test; Smyth et al. 1962) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a142a4fe-9aaf-4fa6-bd42-c3cec33f3246/documents/IUC5-99462e2a-8b05-4819-b3db-5f93b177ca23_7334a6b5-0823-4a32-a32b-f324ed07440e.html,,,,,, "3-dodecyl-1-(2,2,6,6-tetramethyl-4-piperidyl)pyrrolidine-2,5-dione",79720-19-7," In a 28 day oral repeated dose toxicity study rats were exposed to 0, 25, 100 and 300 mg/kg bw/d. Adverse effects (mortality and histiocytosis in small intestines, lungs, adrenals, thymus and mesenteric / axillary lymph nodes, vacuolation in liver, adrenals and kidneys, forestomach foci) were observed in the mid and high dose group. The NOAEL was derived at 25 mg/kg bw/d. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/95022739-aae3-435f-a8ff-a5b3d72747ce/documents/55993bdb-8c25-423b-8dbd-032dab0bd75f_adf8d9f4-e5f7-415f-8ec1-33df879551e7.html,,,,,, "3-dodecyl-1-(2,2,6,6-tetramethyl-4-piperidyl)pyrrolidine-2,5-dione",79720-19-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/95022739-aae3-435f-a8ff-a5b3d72747ce/documents/55993bdb-8c25-423b-8dbd-032dab0bd75f_adf8d9f4-e5f7-415f-8ec1-33df879551e7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat "3-dodecyl-1-(2,2,6,6-tetramethyl-4-piperidyl)pyrrolidine-2,5-dione",79720-19-7, An oral LD50 of 2000 mg/kg bw has been determined after single oral application. Due to the corrosive properties of the substance no tests on acute toxicity after dermal or inhalation exposure have been performed. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95022739-aae3-435f-a8ff-a5b3d72747ce/documents/bf93ace9-ffa0-462a-89f7-a78243f37ca6_adf8d9f4-e5f7-415f-8ec1-33df879551e7.html,,,,,, "3-dodecyl-1-(2,2,6,6-tetramethyl-4-piperidyl)pyrrolidine-2,5-dione",79720-19-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95022739-aae3-435f-a8ff-a5b3d72747ce/documents/bf93ace9-ffa0-462a-89f7-a78243f37ca6_adf8d9f4-e5f7-415f-8ec1-33df879551e7.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "3-ethoxy-1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2-(trifluoromethyl)-hexane",297730-93-9,A 28 day oral gavage study resulted in a NOAEL of 1000 mg/kg bw.A 5 day inhalation study resulted in a NOAEL of 10000 ppm. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c90b2ec-b0d1-41da-b11c-d5e3695e41c8/documents/IUC5-09d6dfd3-9c68-4fc6-975f-a926151c0bae_da8e62e5-3560-4e3f-b566-056c84b88e7d.html,,,,,, "3-ethoxy-1,1,1,2,3,4,4,5,5,6,6,6-dodecafluoro-2-(trifluoromethyl)-hexane",297730-93-9,Acute oral toxicity is greater than 2000 mg/kg bw in rats when tested according to EU Method B.1.Acute dermal toxicity is greater than 2000 mg/kg bw in rats when tested according to OECD method 402.Key Value for Safety Assessment;OralEffect Level: LD50 greater than 2000 mg/kgDermal LD50: Greater than 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c90b2ec-b0d1-41da-b11c-d5e3695e41c8/documents/IUC5-a7340d23-d20d-4ee4-af7a-501a2fe3e0db_da8e62e5-3560-4e3f-b566-056c84b88e7d.html,,,,,, "3-Ethoxy-4,6-difluoro-7-pentoxy-dibenzothiophene",1809320-22-6, The test material was investigated for acute oral toxicity using in vivo methods. The GLP compliant study was fully compliant with OECD TG 423. The follwing results have been obtained: Acute toxicity: oral: OECD 423: LD50 > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb4c2cb7-1635-44d4-b9b6-c3107d2da6ca/documents/b045bdbf-58f1-446a-a5cb-b7c37e9265e9_4484a32d-260b-48c3-93b4-2e614de69ba2.html,,,,,, "3-Ethoxy-4,6-difluoro-7-pentoxy-dibenzothiophene",1809320-22-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb4c2cb7-1635-44d4-b9b6-c3107d2da6ca/documents/b045bdbf-58f1-446a-a5cb-b7c37e9265e9_4484a32d-260b-48c3-93b4-2e614de69ba2.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3-Ethoxycarbonyl-1-(2-fluorbenzyl)-1H-pyrazolo-(3,4,5)-pyridin",256376-59-7,"No experimental data on acute toxicity of the test item is available. An in silico and read-across prediction for acute oral toxicity was conducted on March 19, 2024 using four different tools (DEREK, Leadscope, EPA TEST, OECD TB). The test item was predicted to have an acute oral toxicity and shall be classified with Cat. 4. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9e169be-95cf-4d91-8546-a0c4aab78c5a/documents/8ca15a6f-d1ff-4750-9dfc-e0ee14a7eaeb_88c1edbe-0a8a-4a82-895a-b3525e1b77f7.html,,,,,, "3-ethoxypregna-3,5-diene-21,17α-carbolactone",2649-76-5,"No internal acute toxicity studies of aldonaethylenolether are available. Results of an acute oral toxicity study are cited in RTECS database (Juli 2011):Oral (rat): LD (lethal dose) > 3000 mg/kg(Acute Toxicity Data. Journal of the American College of Toxicology, Part B. (Mary Ann Liebert, Inc., 1651 Third. Ave., New York, NY 10128) V.1- 1990- v. 1, p. 156, 1992 (ATDAEI)) ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abbf5521-317f-4472-9f61-40732ffb00dd/documents/IUC5-18b50bbe-0fe7-4932-8f20-45233ba57a85_54c608dc-cc06-4628-b7e9-d71706dfa17d.html,,,,,, "3-ethyl-5,5-dimethyl-gamma butyrolactone",66094-79-9,"Oral LD50 > 2000 mg/kg bw and the LD50 cut-off  is 2500 mg/kg bw (OECD 423, K, Rel.1, class method in rats) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The key study is GLP compliant and of high quality (Klimisch score 1) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60b79dc3-3ef1-4a9b-97a9-ea6ef77b6557/documents/b465f7c5-40ae-4914-92c5-ff6b9de30e19_bbe84e6d-d103-4d63-8e56-c1c244de177d.html,,,,,, "3-ethyl-5,5-dimethyl-gamma butyrolactone",66094-79-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60b79dc3-3ef1-4a9b-97a9-ea6ef77b6557/documents/b465f7c5-40ae-4914-92c5-ff6b9de30e19_bbe84e6d-d103-4d63-8e56-c1c244de177d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-ethyloxetane-3-methanol,3047-32-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): High quality studies of repeated dose toxicity are available for the submission substance. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1c67867-503a-4707-82e8-4de6db90142b/documents/IUC5-da433765-4574-4cc5-9425-baf93fd452bb_1f4f2220-27e9-488a-8f40-0007417a56d8.html,,,,,, 3-ethyloxetane-3-methanol,3047-32-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1c67867-503a-4707-82e8-4de6db90142b/documents/IUC5-da433765-4574-4cc5-9425-baf93fd452bb_1f4f2220-27e9-488a-8f40-0007417a56d8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 3-ethyloxetane-3-methanol,3047-32-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): A high quality study is available for the submission substance. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): A high quality study is available for the submission substance. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1c67867-503a-4707-82e8-4de6db90142b/documents/IUC5-15760254-91de-4fa2-b700-1f47e66187f5_1f4f2220-27e9-488a-8f40-0007417a56d8.html,,,,,, 3-ethyloxetane-3-methanol,3047-32-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1c67867-503a-4707-82e8-4de6db90142b/documents/IUC5-15760254-91de-4fa2-b700-1f47e66187f5_1f4f2220-27e9-488a-8f40-0007417a56d8.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 3-ethyloxetane-3-methanol,3047-32-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1c67867-503a-4707-82e8-4de6db90142b/documents/IUC5-15760254-91de-4fa2-b700-1f47e66187f5_1f4f2220-27e9-488a-8f40-0007417a56d8.html,,inhalation,LC50,"> 4,930 mg/m3",no adverse effect observed, "3-Fluor-4'-(trans-4-propylcyclohexyl)-1,1'-biphenyl-4-boronic acid",524709-74-8,"OECD 423: LD50 > 2000 mg/kg bw (female rats) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Guideline study under GLP conditions ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e661d7d2-b1e0-49d2-a0e7-0df7aa61b3b5/documents/e08561ce-4253-4391-9ac4-2d441409014d_ea84eb45-d1a7-4be1-8532-461d66036286.html,,,,,, "3-Fluor-4'-(trans-4-propylcyclohexyl)-1,1'-biphenyl-4-boronic acid",524709-74-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e661d7d2-b1e0-49d2-a0e7-0df7aa61b3b5/documents/e08561ce-4253-4391-9ac4-2d441409014d_ea84eb45-d1a7-4be1-8532-461d66036286.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 3-Fluorphenylboric acid,768-35-4, No acute toxicity study needs to be performed as the test item is corrosive to the skin. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bddba969-de08-4edd-82e6-251e4aab901a/documents/e06e3171-e885-4eba-9c42-43bbc9b760dc_eec19406-9a10-4030-b93b-5fa3ca424323.html,,,,,, tetrahydrofuran-3-carbaldehyde,79710-86-4,Acute toxicity oral The acute oral LD50 for this test substance was calculated to be greater than 2000 mg/kg for male rats and 1414 mg/kg for female rats.Acute toxicity inhalationThe four-hour LC50 values for this test substance were geater than 4.48 mg/L (highest attainable concentration) for both male and female rats.  Acute toxicity dermal The acute dermal LD50 for this test substance was greater than 2000 mg/kg for male and female rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67dd525a-a4b8-4cd6-87bc-16aadde55089/documents/IUC5-b19ba2e2-9143-4ad5-8881-3cf518247d18_1a8189fa-fb57-4374-b6f1-8c416ab21257.html,,,,,, tetrahydrofuran-3-carbaldehyde,79710-86-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67dd525a-a4b8-4cd6-87bc-16aadde55089/documents/IUC5-b19ba2e2-9143-4ad5-8881-3cf518247d18_1a8189fa-fb57-4374-b6f1-8c416ab21257.html,,oral,LD50,"1,414 mg/kg bw",adverse effect observed, tetrahydrofuran-3-carbaldehyde,79710-86-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67dd525a-a4b8-4cd6-87bc-16aadde55089/documents/IUC5-b19ba2e2-9143-4ad5-8881-3cf518247d18_1a8189fa-fb57-4374-b6f1-8c416ab21257.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, tetrahydrofuran-3-carbaldehyde,79710-86-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67dd525a-a4b8-4cd6-87bc-16aadde55089/documents/IUC5-b19ba2e2-9143-4ad5-8881-3cf518247d18_1a8189fa-fb57-4374-b6f1-8c416ab21257.html,,inhalation,discriminating conc.,"4,480 mg/m3",no adverse effect observed, N-(tetrahydrofuran-3-ylmethyl)amine,165253-31-6,FAM was tested in a 28 day oral gavage study (OECD 407). No deaths occurred in males and females. The NOEAL was 12 mg/kg bw. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bda8960-4fef-4ff2-a41c-5d54ceb2c075/documents/IUC5-a9e5d962-e7ab-4c3a-b4db-cc55e3af1948_88955141-c901-4cda-9420-147610329bcf.html,,,,,, N-(tetrahydrofuran-3-ylmethyl)amine,165253-31-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bda8960-4fef-4ff2-a41c-5d54ceb2c075/documents/IUC5-a9e5d962-e7ab-4c3a-b4db-cc55e3af1948_88955141-c901-4cda-9420-147610329bcf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,12 mg/kg bw/day,,rat N-(tetrahydrofuran-3-ylmethyl)amine,165253-31-6,LD50(oral): > 2000 mg/kg bw (Mitsui Chem Inc. 2000) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bda8960-4fef-4ff2-a41c-5d54ceb2c075/documents/IUC5-d6b0ebe6-d089-4433-aa7f-edf10b31778b_88955141-c901-4cda-9420-147610329bcf.html,,,,,, "5,6 beta-Epoxy-7 beta-hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5 beta-androstan-17-one",82544-13-6,"Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg [Schering AG, Report No. X236 -draft-, 1997-08-18] Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg [Schering AG, Report No. X299 -draft-, 1998-09-09] Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1707fc1e-219b-42a9-90ee-25d9092162c5/documents/IUC5-3eb316c5-d5ef-4598-bdd8-b178a9840e5d_8bf0e835-2e91-4912-89af-5191979d356b.html,,,,,, "5,6 beta-Epoxy-7 beta-hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5 beta-androstan-17-one",82544-13-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1707fc1e-219b-42a9-90ee-25d9092162c5/documents/IUC5-3eb316c5-d5ef-4598-bdd8-b178a9840e5d_8bf0e835-2e91-4912-89af-5191979d356b.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "5,6 beta-Epoxy-7 beta-hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5 beta-androstan-17-one",82544-13-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1707fc1e-219b-42a9-90ee-25d9092162c5/documents/IUC5-3eb316c5-d5ef-4598-bdd8-b178a9840e5d_8bf0e835-2e91-4912-89af-5191979d356b.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "7 beta-Hydroxy-15 beta,16 beta-methylene-3 beta-pivaloyloxy-5-androsten-17-one",82543-09-7,"Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg[Schering AG, Report No. X239 -draft-, 1997-08-21]Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg[Schering AG, Report No. X317 -draft-, 1998-10-14] ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/897e044d-6ad6-449f-9e4a-fa66a8fb72e7/documents/IUC5-fd49c6c3-16bf-4955-8608-a4f27d311346_13618648-d1c7-4509-8dc9-0f16e347762e.html,,,,,, "3'H-Cycloprop[15,16]androsta-6,15-dien-17-one, 15,16-dihydro-3,5-dihydroxy-, (3beta,5beta,15alpha,16alpha)",82543-15-5,"Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kgDermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33c7bbb9-87dc-4134-adae-4c840227e199/documents/IUC5-22a476ba-62b7-4578-8364-1e02f128e3de_9ba64210-2fc9-44e2-95c3-7e9944ed2f72.html,,,,,, "17-Hydroxy-1 alpha,2 alpha-methylene-4,6-pregnadiene-3,20-dione",2098-65-9,"Oral (Rat, GLP, equivalent to OECD TG 423): no evaluation possible [Schering AG, Report -draft-, 1994-03-25] Oral (Rat, GLP, equivalent to OECD TG 423): LD50 > 2000 mg/kg [Schering AG, Report X026-draft-, 1995-07-19] Dermal (Rat, GLP, equivalent to OECD TG 402): LD50 > 2000 mg/kg [Schering AG, Report No. X110 -draft-, 1996-08-06]   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf7b2e43-1ed8-4b2b-9f1d-40b2a28ed241/documents/IUC5-222a5de9-251f-46eb-bb77-d5a8fed2afd6_727a9636-9f12-4508-9af1-cb8bb0e720d4.html,,,,,, "17-Hydroxy-1 alpha,2 alpha-methylene-4,6-pregnadiene-3,20-dione",2098-65-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf7b2e43-1ed8-4b2b-9f1d-40b2a28ed241/documents/IUC5-222a5de9-251f-46eb-bb77-d5a8fed2afd6_727a9636-9f12-4508-9af1-cb8bb0e720d4.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "17-Hydroxy-1 alpha,2 alpha-methylene-4,6-pregnadiene-3,20-dione",2098-65-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf7b2e43-1ed8-4b2b-9f1d-40b2a28ed241/documents/IUC5-222a5de9-251f-46eb-bb77-d5a8fed2afd6_727a9636-9f12-4508-9af1-cb8bb0e720d4.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 3-heptyloxane,854737-09-0,"Oral LD50 > 2000 mg/kg bw (OECD 423, K, Rel.1, class method in rats) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The key study is GLP compliant and of high quality (Klimisch score 1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b39d885-4702-46d8-8ecb-e65220d62b1a/documents/b7d7cfaf-2319-4f2d-9f39-198749835eeb_2beac77a-b5ea-49a4-b9c6-0683b621e213.html,,,,,, 3-heptyloxane,854737-09-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b39d885-4702-46d8-8ecb-e65220d62b1a/documents/b7d7cfaf-2319-4f2d-9f39-198749835eeb_2beac77a-b5ea-49a4-b9c6-0683b621e213.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "3H-Pyrazol-3-one, 2,4-dihydro-5-methyl-2-phenyl-, 4-[(4-C7-17-branched alkylphenyl)azo] derivs.",97660-72-5, A limit dose acute oral toxicity study in the rat is available for this substance ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2011288-df2d-468d-a3da-9ebe67b9a60b/documents/b452fa61-3530-4c8f-886a-7df16d6ab936_0feeffd6-3a79-407f-833c-d326bf242542.html,,,,,, "3-hydroxy-1,1-dimethylbutyl 2-ethyl-2-methylheptaneperoxoate",1467668-33-2,In an OECD 408 test (GLP) the No Observed Adverse Effect Level (NOAEL) was established at 300 mg/kg/day and the No Observed Effect Level (NOEL) at 100 mg/kg/day in males and females taking into account that the adverse effects observed in male rat kidneys are not relevant for humans. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee12538e-ca3d-4ffc-887a-01b5cb38a2ff/documents/IUC5-4dc56d54-c4a6-4290-a768-594972a64e33_7c1cf585-e903-48f1-a93d-81e380514097.html,,,,,, "3-hydroxy-1,1-dimethylbutyl 2-ethyl-2-methylheptaneperoxoate",1467668-33-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee12538e-ca3d-4ffc-887a-01b5cb38a2ff/documents/IUC5-4dc56d54-c4a6-4290-a768-594972a64e33_7c1cf585-e903-48f1-a93d-81e380514097.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "3-hydroxy-1,1-dimethylbutyl 2-ethyl-2-methylheptaneperoxoate",1467668-33-2,"The LD0 in rats exposed to 3-hydroxy-1,1-dimethylbutylperoxy-neodecanoate are more than 2000 mg/kg after oral or dermal exposure. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee12538e-ca3d-4ffc-887a-01b5cb38a2ff/documents/IUC5-c2d5a66d-06b5-4d8c-a20c-9e3f2f192dc9_7c1cf585-e903-48f1-a93d-81e380514097.html,,,,,, "3-hydroxy-1,1-dimethylbutyl 2-ethyl-2-methylheptaneperoxoate",1467668-33-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee12538e-ca3d-4ffc-887a-01b5cb38a2ff/documents/IUC5-c2d5a66d-06b5-4d8c-a20c-9e3f2f192dc9_7c1cf585-e903-48f1-a93d-81e380514097.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3-hydroxy-1,1-dimethylbutyl 2-ethyl-2-methylheptaneperoxoate",1467668-33-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee12538e-ca3d-4ffc-887a-01b5cb38a2ff/documents/IUC5-c2d5a66d-06b5-4d8c-a20c-9e3f2f192dc9_7c1cf585-e903-48f1-a93d-81e380514097.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one,17772-51-9,"Repeated dose toxicity by oral route: NO(A)EL(male/female) = 1000 mg/kg bw/day (OECD 407, GLP, K, rel.1) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2e111d1-459f-43cf-b212-341a8c979bd3/documents/3e8df712-2276-4403-8d9e-01aa5e053d12_54673ec4-1fb9-4175-bc79-cfd21ec28ff4.html,,,,,, 3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one,17772-51-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2e111d1-459f-43cf-b212-341a8c979bd3/documents/3e8df712-2276-4403-8d9e-01aa5e053d12_54673ec4-1fb9-4175-bc79-cfd21ec28ff4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one,17772-51-9,"Acute toxicity via Oral route: Combined LD50 > 5000 mg/kg bw (eq. OECD 401, K, Rel.2). Acute toxicity via Dermal route: Combined LD50 > 2000 mg/kg bw (OECD 402, GLP, K, Rel.1). Acute toxicity via Inhalation route: Study not technically feasible. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2e111d1-459f-43cf-b212-341a8c979bd3/documents/45718fb1-057c-4186-b436-1d9f72d1cb07_54673ec4-1fb9-4175-bc79-cfd21ec28ff4.html,,,,,, 3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one,17772-51-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2e111d1-459f-43cf-b212-341a8c979bd3/documents/45718fb1-057c-4186-b436-1d9f72d1cb07_54673ec4-1fb9-4175-bc79-cfd21ec28ff4.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, 3-hydroxy-2-(3-hydroxy-2-quinolyl)-1H-inden-1-one,17772-51-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2e111d1-459f-43cf-b212-341a8c979bd3/documents/45718fb1-057c-4186-b436-1d9f72d1cb07_54673ec4-1fb9-4175-bc79-cfd21ec28ff4.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 3-hydroxy-2'-methyl-2-naphthanilide,135-61-5,Ten female rats were treated with 5000 mg/kg bw of Naphtol AS D in sesame oil via single gavage. No adverse effects were observed during the observation period as well as at necropsy. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85a70655-3946-4d6f-9aa1-0f56f94a30b5/documents/IUC5-2abc146e-5351-4de1-8c3f-f53dbc112912_f843c263-5392-45cd-ac68-769c6965217b.html,,,,,, 3-hydroxy-2-methylquinoline-4-carboxylic acid,117-57-7,An inhalation study (concentration x time method) was conducted in rats. No information about the exposure concentration was reported. Therefore the study is not suitable for assessment and classification. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61238c09-de77-487e-96a4-d3e2686010e4/documents/b5429864-e956-4536-8874-c8d1fe262e46_7951f553-9a7b-47ed-8cfe-62f1d923ba4a.html,,,,,, 3-hydroxy-2-methylquinoline-4-carboxylic acid,117-57-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61238c09-de77-487e-96a4-d3e2686010e4/documents/b5429864-e956-4536-8874-c8d1fe262e46_7951f553-9a7b-47ed-8cfe-62f1d923ba4a.html,,oral,LD50,"1,700 mg/kg bw",adverse effect observed, 3-hydroxy-2-methylquinoline-4-carboxylic acid,117-57-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61238c09-de77-487e-96a4-d3e2686010e4/documents/b5429864-e956-4536-8874-c8d1fe262e46_7951f553-9a7b-47ed-8cfe-62f1d923ba4a.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide,6471-49-4," 17 days repeated dose toxicity study was conducted in F344 male and female rats by administratingC.I. Pigment Red 23 orally at doses0, 600, 1200, 2500, 5000, 10000 mg/kg/day. There were no clinical and mortality were observed. No biologically significant differences recorded in organ weights among exposed and control rats. Decreased erythrocyte count observed in the two highest female and male dose groups, indicating a mild anemia. Therefore, NOAEL value for substanceC.I. Pigment Red 23 is considered to be 5000 mg/kg/day in F344 female rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11e03048-4942-4aa9-bded-7f22273e9b9a/documents/37a54383-5727-4890-b4d7-5ee640c18a59_f36a24eb-869f-474c-a2d1-3f258a1cf6eb.html,,,,,, 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide,6471-49-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11e03048-4942-4aa9-bded-7f22273e9b9a/documents/37a54383-5727-4890-b4d7-5ee640c18a59_f36a24eb-869f-474c-a2d1-3f258a1cf6eb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide,6471-49-4," Acute oral toxicity:  Acute oral toxicity dose (LD50) for 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide (CAS no:6471-49-4) was considered based on Sustainability Support Services (Europe) AB > 10000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide (CAS no:6471-49-4) has very low vapour pressure (5E-17 Pa at 25°C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11e03048-4942-4aa9-bded-7f22273e9b9a/documents/9d0aabcd-31cb-4e4b-a794-e3e019ab385f_f36a24eb-869f-474c-a2d1-3f258a1cf6eb.html,,,,,, 3-hydroxy-4-[(2-methoxy-5-nitrophenyl)azo]-N-(3-nitrophenyl)naphthalene-2-carboxamide,6471-49-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11e03048-4942-4aa9-bded-7f22273e9b9a/documents/9d0aabcd-31cb-4e4b-a794-e3e019ab385f_f36a24eb-869f-474c-a2d1-3f258a1cf6eb.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, 3-hydroxy-4-[(2-methyl-4-nitrophenyl)azo]-N-(o-tolyl)naphthalene-2-carboxamide,6410-32-8,"Repeated oral toxicity: PR 112 The toxicity of the test item when given by oral administration (gavage) to groups of 5 rats per sex per dose for 28 consecutive days at dosages of 0, 100, 300 or 1000 mg/kg bw/day, for 7 days/week have been investigated. No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). Red staining of various body parts, red faeces and reddish contents of the gastro-intestinal tract noted among all groups treated with the test substance was considered to be related to staining properties of the test substance, and not to represent signs of systemic toxicity. No correlating histopathological abnormalities were noted. On the basis of these results, the high dose level of 1000 mg/kg/day was considered to be the No Observed Adverse Effect Level (NOAEL) for the test substance. PR022 A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test was performed according to OECD TG 422. The test item was administered to Sprague Dawley rats (12/sex/dose) by gavage at dose levels of 0, 100, 300 and 1000 mg/kg/day for a total of 37 days (males) and through mating, gestation and delivery until day 4 of lactation (females). No toxic effects were observed in this study except increased liver weights in males and females of the highest dose group. As the effects on liver weight were minimal (less than 10% weight changes) and not accompanied by any histopathological or biochemical changes these effects were judged not to be adverse. The no-observed-adverse-effect level (NOAEL) for repeated dose toxicity was 1000 mg/kg under the conditions of this study. There were no effects on reproduction or development.   Repeated inhalation toxicity: The objective of the OECD TG 413 following study was to determine the toxic potential of the test item and close analogue, Pigment Red 112, when administered for 6 hours/day, 5 days per week, for 13 consecutive weeks by flow-past nose-only inhalation route to Sprague Dawley rats. This study provides information on toxic effects, target organs, the possibility of cumulative effects, the reversibility of effects (after 90 and 180 days recovery period), and an estimate of the No Observed Adverse Effects Concentration (NOAEC). Based on the observed results, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item was found to be 30 mg/m³ (0,03 mg/L) after 90 days of exposure (highest concentration tested). The nominal dose of 0.03 mg/L (6 hrs/day, 5 days/week) corresponded to an actual exposure concentration in males and females.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): reliable and valid Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): valid and reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): valid and reliable ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0182a228-15d2-4713-86fe-8ec145d0acdd/documents/5e619b8e-c845-4b5d-94a4-495a8c3ca502_a2bd617a-3216-4e1d-a883-fd46569bb643.html,,,,,, 3-hydroxy-4-[(2-methyl-4-nitrophenyl)azo]-N-(o-tolyl)naphthalene-2-carboxamide,6410-32-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0182a228-15d2-4713-86fe-8ec145d0acdd/documents/5e619b8e-c845-4b5d-94a4-495a8c3ca502_a2bd617a-3216-4e1d-a883-fd46569bb643.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 3-hydroxy-4-[(2-methyl-4-nitrophenyl)azo]-N-(o-tolyl)naphthalene-2-carboxamide,6410-32-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0182a228-15d2-4713-86fe-8ec145d0acdd/documents/5e619b8e-c845-4b5d-94a4-495a8c3ca502_a2bd617a-3216-4e1d-a883-fd46569bb643.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat 3-hydroxy-4-[(2-methyl-4-nitrophenyl)azo]-N-(o-tolyl)naphthalene-2-carboxamide,6410-32-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0182a228-15d2-4713-86fe-8ec145d0acdd/documents/5e619b8e-c845-4b5d-94a4-495a8c3ca502_a2bd617a-3216-4e1d-a883-fd46569bb643.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,,rat 3-hydroxy-4-[(2-methyl-4-nitrophenyl)azo]-N-(o-tolyl)naphthalene-2-carboxamide,6410-32-8,"Single application of 15000 mg test substance (PR012) per kg bw did not cause lethality in female Wistar-rats during the 15 day observation period, resulting in a LD50 > 15000 mg/kg bw.In addition, testing the close analogue, Pigment Red 112, did not cause any mortality or significant clinical signs or necropsy findings after single dermal application to male rats at 5000 mg/kg bw in a OECD guideline compliant study. The LD50 (male rat) was greater than 5000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0182a228-15d2-4713-86fe-8ec145d0acdd/documents/b06ced7c-28ef-4c72-803a-e52df689314b_a2bd617a-3216-4e1d-a883-fd46569bb643.html,,,,,, 3-hydroxy-4-[(2-methyl-4-nitrophenyl)azo]-N-(o-tolyl)naphthalene-2-carboxamide,6410-32-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0182a228-15d2-4713-86fe-8ec145d0acdd/documents/b06ced7c-28ef-4c72-803a-e52df689314b_a2bd617a-3216-4e1d-a883-fd46569bb643.html,,oral,LD50,"> 15,000 mg/kg bw",no adverse effect observed, 3-hydroxy-4-[(2-methyl-4-nitrophenyl)azo]-N-(o-tolyl)naphthalene-2-carboxamide,6410-32-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0182a228-15d2-4713-86fe-8ec145d0acdd/documents/b06ced7c-28ef-4c72-803a-e52df689314b_a2bd617a-3216-4e1d-a883-fd46569bb643.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, 3-hydroxy-p-anisaldehyde,621-59-0, Acute oral toxicity: Key study: OECD 423 and EU method B.1 tris. GLP study. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off of the test item may be considered to be higher than 5000 mg/kg body weight by oral route in the rat. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38c5c43a-7144-49cd-8d6e-1c3257101824/documents/a6622993-e350-4586-bec2-7f95365a640f_e4aaa866-2d9f-46ee-9564-03f8462eb05b.html,,,,,, 3-hydroxy-p-anisaldehyde,621-59-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38c5c43a-7144-49cd-8d6e-1c3257101824/documents/a6622993-e350-4586-bec2-7f95365a640f_e4aaa866-2d9f-46ee-9564-03f8462eb05b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 3-hydroxypropiononitrile,109-78-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d92192ef-3659-47a1-9a6b-28a81bf848bf/documents/e2920f7d-25a7-4461-9d3e-8cce2bbef536_61357998-eafd-4597-90b9-e2082c698b0e.html,,oral,LD50,"6,000 mg/kg bw",, 3-icosyl-4-henicosylidene-2-oxetanone,83708-14-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2c9e436-d3e4-4b59-9b14-2687899af4aa/documents/IUC5-6ff8427f-32e8-474a-91da-aab6adeee6b4_8649ed5e-bf89-4f6f-81c3-f4eae7655747.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat 3-icosyl-4-henicosylidene-2-oxetanone,83708-14-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2c9e436-d3e4-4b59-9b14-2687899af4aa/documents/IUC5-6ff8427f-32e8-474a-91da-aab6adeee6b4_8649ed5e-bf89-4f6f-81c3-f4eae7655747.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers, reaction products with 2-butanone oxime",103170-26-9," No repeated-dose toxicity tests are available for the oral or dermal route of exposure. Data waivers are claimed. In a subchronic inhalation toxicity study with 13 week exposure and 13 week recovery period the No-Observed-Adverse-Effect-Concentration (NOAEC) is 1.5 mg/m³ due to respiratory tract associated adverse findings seen in BAL, histopathology and weight increase of lung and LALN at 7.6 mg/m³. These effects represent portal-of-entry toxicity. Test substance related systemic toxicity was not observed and thus, the NOAEC for systemic toxicity is 7.6 mg/m³, the highest dose tested. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3ffdfca-2965-488c-adb3-b0087c0b3ba1/documents/e3a36a9a-01b8-462d-82d3-214c35f8cb59_7049812f-ae51-4c09-8043-ab2b80f24b79.html,,,,,, "3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers, reaction products with 2-butanone oxime",103170-26-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3ffdfca-2965-488c-adb3-b0087c0b3ba1/documents/e3a36a9a-01b8-462d-82d3-214c35f8cb59_7049812f-ae51-4c09-8043-ab2b80f24b79.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1.5 mg/m3,adverse effect observed,rat "3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers, reaction products with 2-butanone oxime",103170-26-9,aktue oral toxicity: LD50 > 2000 mg/kg bwacute inhalation toxicity: LC50 > 5142 mg/m³ ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3ffdfca-2965-488c-adb3-b0087c0b3ba1/documents/8cdff4c9-ea4e-4d4b-b133-d46fbc7390c3_7049812f-ae51-4c09-8043-ab2b80f24b79.html,,,,,, "3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers, reaction products with 2-butanone oxime",103170-26-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3ffdfca-2965-488c-adb3-b0087c0b3ba1/documents/8cdff4c9-ea4e-4d4b-b133-d46fbc7390c3_7049812f-ae51-4c09-8043-ab2b80f24b79.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3-Isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate, oligomers, reaction products with 2-butanone oxime",103170-26-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3ffdfca-2965-488c-adb3-b0087c0b3ba1/documents/8cdff4c9-ea4e-4d4b-b133-d46fbc7390c3_7049812f-ae51-4c09-8043-ab2b80f24b79.html,,inhalation,discriminating conc.,"5,142 mg/m3",no adverse effect observed, 3-isopropoxypropylamine,2906-12-9,"In acute oral toxicity studies with isopropoxypropylamine, LD50 of 909 and ca. 1050 mg/kg bw were determined in rats. By inhalation exposure of rats to saturated vapors of isopropoxypropylamine generated at 20°C showed 5/6 deaths after exposure for 8 hours, 1/6 death after exposure for 3 hours and 0/12 death after exposure for 1 hour. There is no acute dermal toxicity study on isopropoxypropylamine, but the acute toxicity by dermal route of the analogue substance 3-methoxypropylamine was estimated to be 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb5f9850-3d6a-4c9b-be3b-9ed4fc734790/documents/c9773582-47dd-4695-b628-b62eb84bfef1_067e68b6-8de9-4c69-a9b7-33ad683af512.html,,,,,, 3-isopropoxypropylamine,2906-12-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb5f9850-3d6a-4c9b-be3b-9ed4fc734790/documents/c9773582-47dd-4695-b628-b62eb84bfef1_067e68b6-8de9-4c69-a9b7-33ad683af512.html,,oral,LD50,909 mg/kg bw,adverse effect observed, 3-isopropoxypropylamine,2906-12-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb5f9850-3d6a-4c9b-be3b-9ed4fc734790/documents/c9773582-47dd-4695-b628-b62eb84bfef1_067e68b6-8de9-4c69-a9b7-33ad683af512.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, 3-Methoxy-3-methylbutyl acetate,103429-90-9," The substance was administered orally by gavage (in accordance with OECD 422, Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Screening Test and GLP criteria) to 12 male and 12 female rats per dose. The following doses were given: 0, 25, 150 and 1000 mg/kg/day. The aim of the study was to determine the potential systemic and reproductive toxicities in parental animals and developmental toxicity of the offspring. The administration of the test substance was conducted for 42 days in males and until day 4 in females of the nursing period. The recovery groups were kept for 14 days in the vehicle control and 1000 mg/kg groups, which was 5 out of 12 males and 5 additional females. The females of the recovery groups were not mated. The following observation were made: Body weights and food intakes decreased in females of the 1000 mg/kg group on day 4 of the nursing period. The hematologic observations revealed decreases in red blood counts (RBC) in males and females and decreases in haemoglobin concentration and haematocrit values in female in the 1000 mg/kg groups. No abnormalities were noted in the clinical signs, functional observational battery (FOB), bloody chemistry, organ weights, necropsy and histopathology. Decreases in RBC, haemoglobin concentration and haematocrit values were not observed after 14-day recovery period. The NOAEL of the MMB-AC in the repeated dose toxicity study is 150 mg/kg /day for both sexes due to the decreases in RBC in males and females, decreases in haemoglobin concentration and haematocrit values in females and decreased in body weights and food intakes in females on day 3 of the nursing period in the 1000 mg/kg bw.   ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3418c9b9-d074-4696-88d4-1a346af26682/documents/ec8cdc8e-adbd-4438-98c1-4578bf0e07ac_79c8953f-69a5-491a-b1bb-1c2f3b62fa79.html,,,,,, 3-Methoxy-3-methylbutyl acetate,103429-90-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3418c9b9-d074-4696-88d4-1a346af26682/documents/ec8cdc8e-adbd-4438-98c1-4578bf0e07ac_79c8953f-69a5-491a-b1bb-1c2f3b62fa79.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat 3-Methoxy-3-methylbutyl acetate,103429-90-9, Oral LD50 in rats for both sexes combined = 4600 mg/kg. Dermal LD50 in rats > 2000 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3418c9b9-d074-4696-88d4-1a346af26682/documents/IUC5-e081cc67-dca9-46c0-a095-ffddff1876b8_79c8953f-69a5-491a-b1bb-1c2f3b62fa79.html,,,,,, 3-Methoxy-3-methylbutyl acetate,103429-90-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3418c9b9-d074-4696-88d4-1a346af26682/documents/IUC5-e081cc67-dca9-46c0-a095-ffddff1876b8_79c8953f-69a5-491a-b1bb-1c2f3b62fa79.html,,oral,LD50,"4,600 mg/kg bw",adverse effect observed, 3-methoxyacetophenone,586-37-8,LD50 was estimated to be 1000 mg/kg bw on mouse for substance m-Methoxyacetophenone. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/265a5dea-2c88-4b4b-9487-5f49e091bdd6/documents/IUC5-cdbc1b0e-78c6-421c-b354-8971fe2873b6_cdd45a30-cc93-4268-afdd-7eb7ced659c6.html,,,,,, 3-methoxyacetophenone,586-37-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/265a5dea-2c88-4b4b-9487-5f49e091bdd6/documents/IUC5-cdbc1b0e-78c6-421c-b354-8971fe2873b6_cdd45a30-cc93-4268-afdd-7eb7ced659c6.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, 3-methoxybutyl acetate,4435-53-4,"Taking information into account both for putative metabolites and for closely related structural analogues of 3-methoxybutyl acetate highlights the significant extent of the toxicology database that is available to assess the repeat-dose toxicity profile. An understanding of the likely metabolic fate, and hence systemic exposure profiles of these substances, underpins the repeat-dose toxicity profile. The repeat-dose toxicity of the structural analogue of 3-methoxybutan-1-ol, namely 3-methoxy-3-methyl-butanol, has been assessed in guideline 90-day studies. The lowest NOEL was 60 mg/kg/day (LEL=200mg/kg/day) and was based on reversible liver/kidney effects (in the absence of histopathological change) and considered by the authors as non-adverse. Although such effects have not been reported in any short-term 3-methoxybutyl acetate study, as this is the lowest NOEL reported for any structural analogues of 3-methoxybutyl acetate considered in this review, it is used albeit as a conservative surrogate NOEL for 3-methoxybutyl acetate. Thus the NOEL for 3-methoxybutyl acetate repeat-dose toxicity is considered to be 60 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e029b90-c5b8-44c5-8787-3a346ee56685/documents/IUC5-a8ba0175-4be5-4d45-910e-6da9df3d5a65_e9ae85bb-3b5b-45bf-b29a-67aa42ba871c.html,,,,,, 3-methoxybutyl acetate,4435-53-4,"There are sufficient data to assess the acute toxicity of 3-methoxylbutyl acetate and it is considered to have low acute toxicity by oral, inhalation and dermal routes of exposure. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e029b90-c5b8-44c5-8787-3a346ee56685/documents/IUC5-60348ded-0255-47ce-b27b-84bcf5fd2a2d_e9ae85bb-3b5b-45bf-b29a-67aa42ba871c.html,,,,,, "3-methoxyestra-2,5(10)-dien-17β-ol",1091-93-6,"LD50 oral (rat): > 2000 mg/kg bw [Draft report, Kurth 1995]LD50 dermal (rat): > 2000 mg/kg bw [Draft report, Treher 1996] ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fa6e202-a43d-4114-b630-4988be4e2197/documents/IUC5-3e81c6c9-6e97-4fb9-8825-ba791327403c_df874862-d3c1-41f3-a514-6c5aafb35c18.html,,,,,, "3-methoxyestra-2,5(10)-dien-17β-ol",1091-93-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fa6e202-a43d-4114-b630-4988be4e2197/documents/IUC5-3e81c6c9-6e97-4fb9-8825-ba791327403c_df874862-d3c1-41f3-a514-6c5aafb35c18.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3-methoxyestra-2,5(10)-dien-17β-ol",1091-93-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fa6e202-a43d-4114-b630-4988be4e2197/documents/IUC5-3e81c6c9-6e97-4fb9-8825-ba791327403c_df874862-d3c1-41f3-a514-6c5aafb35c18.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3-methoxy-N,N-dimethylpropionamide",53185-52-7," A 28-day oral repeated dose toxicity study was conducted with test substance according to OECD 407 guideline. The NOAEL was determined to be 25 mg/kg bw/day based on increased liver weights, enlargement of the liver and higher level of total cholesterol in both sexes at 150 and 1000 mg/kg bw/day. A 90-day oral repeated dose toxicity study was conducted with test substance according to OECD 408 guideline. The NOAEL of test substance was determined to be 10 mg/kg bw/day based on the increases in the liver and kidney weights accompanied by histopathological and serum chemistry changes at 100 and/or 1000 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f007ef54-d5ea-4ad8-a4c5-98edaf369666/documents/cac5c547-bd39-40c8-92f5-7425a5584b1e_b3bdfae7-2304-4226-ac1f-4697c5f2dbad.html,,,,,, "3-methoxy-N,N-dimethylpropionamide",53185-52-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f007ef54-d5ea-4ad8-a4c5-98edaf369666/documents/cac5c547-bd39-40c8-92f5-7425a5584b1e_b3bdfae7-2304-4226-ac1f-4697c5f2dbad.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat "3-methoxy-N,N-dimethylpropionamide",53185-52-7, Acute oral (OECD423): LD50 >2000 mg/kg bw Acute inhalation (OECD403): LC50 >5 mg/L Acute dermal (OECD402): LD50 >2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f007ef54-d5ea-4ad8-a4c5-98edaf369666/documents/8362b0df-f6ba-43b3-986a-d0143bfe6541_b3bdfae7-2304-4226-ac1f-4697c5f2dbad.html,,,,,, "3-methoxy-N,N-dimethylpropionamide",53185-52-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f007ef54-d5ea-4ad8-a4c5-98edaf369666/documents/8362b0df-f6ba-43b3-986a-d0143bfe6541_b3bdfae7-2304-4226-ac1f-4697c5f2dbad.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-methoxy-N,N-dimethylpropionamide",53185-52-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f007ef54-d5ea-4ad8-a4c5-98edaf369666/documents/8362b0df-f6ba-43b3-986a-d0143bfe6541_b3bdfae7-2304-4226-ac1f-4697c5f2dbad.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-methoxy-N,N-dimethylpropionamide",53185-52-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f007ef54-d5ea-4ad8-a4c5-98edaf369666/documents/8362b0df-f6ba-43b3-986a-d0143bfe6541_b3bdfae7-2304-4226-ac1f-4697c5f2dbad.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "3-methoxyoestra-1,3,5(10)-trien-17-one",1624-62-0,Acute toxicity oral: LD50 > 2000 mg/kg bw (Kurth 1994) Acute toxicity dermal: LD50 > 2000 mg/kg bw (Kurth 1996) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93e35237-f3b1-4bca-b0d8-8b68dc1d6deb/documents/IUC5-b7ee62c6-60a1-49f9-9cdd-bfe99e402cbd_2813eff5-8ecb-4308-902e-c60750f27671.html,,,,,, "3-methoxyoestra-1,3,5(10)-trien-17-one",1624-62-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93e35237-f3b1-4bca-b0d8-8b68dc1d6deb/documents/IUC5-b7ee62c6-60a1-49f9-9cdd-bfe99e402cbd_2813eff5-8ecb-4308-902e-c60750f27671.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3-methoxyoestra-1,3,5(10)-trien-17-one",1624-62-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93e35237-f3b1-4bca-b0d8-8b68dc1d6deb/documents/IUC5-b7ee62c6-60a1-49f9-9cdd-bfe99e402cbd_2813eff5-8ecb-4308-902e-c60750f27671.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 3-methoxypropiononitrile,110-67-8,According to Smith et al. the LD50 is 4.39 g/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86ee3a71-0e4c-4a3d-9c92-bd827e42a2c2/documents/e6e56d7b-3fcb-4412-a758-083ea2332074_b234b61f-7f3a-44aa-b5f0-a7b4f04e0632.html,,,,,, 3-methoxypropiononitrile,110-67-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86ee3a71-0e4c-4a3d-9c92-bd827e42a2c2/documents/e6e56d7b-3fcb-4412-a758-083ea2332074_b234b61f-7f3a-44aa-b5f0-a7b4f04e0632.html,,oral,LD50,"4,390 mg/kg bw",adverse effect observed, 3-methoxypropylamine,5332-73-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db98bf60-3dd6-4f05-a6f5-b44fe85205f2/documents/554d4b83-9948-4f81-8f4d-f5d56adb42cb_4ac3ee36-ce53-446b-aeb3-3c3329997703.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 3-methoxypropylamine,5332-73-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db98bf60-3dd6-4f05-a6f5-b44fe85205f2/documents/5a6e619d-ca0a-4158-99bf-3b61809dbb46_4ac3ee36-ce53-446b-aeb3-3c3329997703.html,,oral,LD50,688.1 mg/kg bw,adverse effect observed, 3-methoxypropylamine,5332-73-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db98bf60-3dd6-4f05-a6f5-b44fe85205f2/documents/5a6e619d-ca0a-4158-99bf-3b61809dbb46_4ac3ee36-ce53-446b-aeb3-3c3329997703.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-methyl-1,1-diphenylurea",13114-72-2," Only one study is available. The test substance, Akardit, was tested for reproduction and subacute toxicity using the OECD Test Guideline No. 422: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, Adopted by the Council on March 22nd 1996. Only one study available. GLP study. Klimish score 1. The test substancehad effect on growth of animals (body weight loss or decreased body weight and body weight increment), clinical status (symptoms of irritation and stress), biochemical parameters (increased value of cholesterol total value of bilirubin total, value of creatinine, value of bile acids, activity of ALT and ALP, concentration of chloride ions in males,concentration of calcium ions, concentration ofpotassium ions, inorganic phosphorusand decreased concentration of chloride ions in females, value of glucose, activity of AST, value of triglycerides, value ofcholinesterase), biometry of organs (mainly increased weight of liver) and urine parameters (mainly change of colour urine and presence of bilirubin). The test substance had influence on microscopical structure of liver in both sexes (mainly vacuolation of hepatocytes and delayed occurrence of focal necrosis). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f81b892c-de56-4929-a8b8-23ba0002660e/documents/IUC5-3caf7b51-017d-45ba-b85a-eea995fb919b_8b324e90-097b-47a7-87bf-d57895c4cb7d.html,,,,,, "3-methyl-1,1-diphenylurea",13114-72-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f81b892c-de56-4929-a8b8-23ba0002660e/documents/IUC5-3caf7b51-017d-45ba-b85a-eea995fb919b_8b324e90-097b-47a7-87bf-d57895c4cb7d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,140 mg/kg bw/day,,rat "3-methyl-1,1-diphenylurea",13114-72-2," Acute Toxicity- Oral point Only one study is available. GLP study. Klimish score 1. The testing was performed according to the Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008. LD50=> 300 mg/kg to < 2000 mg/kg (for female) Acute Toxicity - Dermal point Only one study is avalable. GLP study. Klimish score 1. Testing was performed according to Method B.3 - Acute toxicity(Dermal), Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008. LD50>2000 mg/kg/bw (for male/female) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f81b892c-de56-4929-a8b8-23ba0002660e/documents/55d91196-5300-4bdb-8498-e42941bf864d_8b324e90-097b-47a7-87bf-d57895c4cb7d.html,,,,,, "3-methyl-1,1-diphenylurea",13114-72-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f81b892c-de56-4929-a8b8-23ba0002660e/documents/55d91196-5300-4bdb-8498-e42941bf864d_8b324e90-097b-47a7-87bf-d57895c4cb7d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-methyl-1,3-butanediol-1-ethylate",5205-01-6," Short summary and overall relevance of the provided information on acute oral toxicity Animals selected for the study were randomised by weight and group allocated. The method used to investigate the acute oral toxicity of 3-methyl-1,3 -butanediol acetate was the acute oral fixed procedure (OECD 420 (2001)).The test article was dissolved in water and administered to a single female fasted Wistar rat/dose level by oral gavage at a dose levels of 300 or 2000 mg/kg bw in an initial sighting study. Animals dosed at 2000 mg/kg bw received the test article as supplied by the Sponsor, without vehicle. A further four female rats were dose orally via gavage at 2000 mg/kg bw, employing a dose volume of 10 mL/kg bw. The observation period was 14 d post dosing, with gross pathology undertaken for all animals.   No clinical signs of toxicity or mortality were observed in rats in the sighting or main study. Body weight gain of these animals was normal. No treatment related gross pathological findings were noted in the animals.   Under the conditions of this study the rat acute oral LD50 was >2000 mg/kg bw. Therefore, according to Annex I for Regulation (EC) 1272/2008 the formulation has no obligatory labelling requirement for acute oral toxicity and is unclassified.   Short summary and overall relevance of the provided information on acute inhalation toxicity Not relevant for REACh Annex VII, tonnage band 1-10.   Short summary and overall relevance of the provided information on acute dermal toxicity Not relevant for REACh Annex VII, tonnage band 1-10. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff033150-047d-4d86-b4fe-aa88a162c002/documents/4df26a90-10b6-4967-af9b-85b921466a6e_2fb9ce3f-de01-4d4b-b041-88bec6e7d0c2.html,,,,,, "3-methyl-1,3-butanediol-1-ethylate",5205-01-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff033150-047d-4d86-b4fe-aa88a162c002/documents/4df26a90-10b6-4967-af9b-85b921466a6e_2fb9ce3f-de01-4d4b-b041-88bec6e7d0c2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-methyl-1,5-pentanediyl diacrylate",64194-22-5,"The repeated toxicity of 3 -methyl-1,5 -pentanediyl diacrylate was evaluated after daily administration (gavage) to rats at dose levels of 25, 75 or 300 mg/kg/day for 13 weeks. The test item was clinically well tolerated at all dose levels and induced only non adverse changes in pathology. Consequently, under the experimental conditions of the study, based on the absence of adverse effects, the No Observed Adverse Effect Level (NOAEL) after the 13 -week treatment period was established at 300 mg/kg/day in both sexes. The key study is considered to be reliable with a klimisch score of 1. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d24cb6e5-5618-451d-982d-fb20a26db831/documents/IUC5-85743db0-617e-4117-b9f3-8f5683664114_dcf9a625-1039-4dcc-aefe-6c777d5fcf5c.html,,,,,, "3-methyl-1,5-pentanediyl diacrylate",64194-22-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d24cb6e5-5618-451d-982d-fb20a26db831/documents/IUC5-85743db0-617e-4117-b9f3-8f5683664114_dcf9a625-1039-4dcc-aefe-6c777d5fcf5c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "3-methyl-1,5-pentanediyl diacrylate",64194-22-5,"The potential of acute toxicity of 3-methyl-1,5-pentanediyl diacrylate was evaluated in three studies. No mortalities were showed in the oral and dermal studies at the highest tested dose; the oral and dermal LD50 were higher than 2000 mg/kg in rats. By inhalation, 3-methyl-1,5-pentanediyl diacrylate showed adverse effects as mortality and severe clinical signs at 5 mg/l, but not at 1 mg/l, so the LC50 is considered to be between 1 and 5 mg/l. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d24cb6e5-5618-451d-982d-fb20a26db831/documents/IUC5-bcf4cf6d-a9b7-4ec4-abb6-c6ef1ce338d2_dcf9a625-1039-4dcc-aefe-6c777d5fcf5c.html,,,,,, "3-methyl-1,5-pentanediyl diacrylate",64194-22-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d24cb6e5-5618-451d-982d-fb20a26db831/documents/IUC5-bcf4cf6d-a9b7-4ec4-abb6-c6ef1ce338d2_dcf9a625-1039-4dcc-aefe-6c777d5fcf5c.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3-methyl-1,5-pentanediyl diacrylate",64194-22-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d24cb6e5-5618-451d-982d-fb20a26db831/documents/IUC5-bcf4cf6d-a9b7-4ec4-abb6-c6ef1ce338d2_dcf9a625-1039-4dcc-aefe-6c777d5fcf5c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3-methyl-1,5-pentanediyl diacrylate",64194-22-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d24cb6e5-5618-451d-982d-fb20a26db831/documents/IUC5-bcf4cf6d-a9b7-4ec4-abb6-c6ef1ce338d2_dcf9a625-1039-4dcc-aefe-6c777d5fcf5c.html,,inhalation,LC50,1 mg/m3,adverse effect observed, 3-methyl-1-benzofuran-5-ol,7182-21-0,"The repeated dose toxicity of the test substance, TM 11-0230, was assessed according to OECD Test Guideline 422 using a Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening method. The No Observed Effect Level (NOEL) for females was considered to be 2500 ppm (equivalent to a mean achieved dosage of 162.9 mg/kg bw/day) due to the microscopic changes evident in the oesophagus and stomach at 7500 ppm. A No Observed Effect Level (NOEL) for males was not established due to the presence of hyaline droplets in all treated males. However if this is ignored, considering it is male rat specific and not relevant to humans, the NOEL for males becomes 2500 ppm (equivalent to a mean achieved dosage of 138.0 mg/kg bw/day). A “No Observed Adverse Effect Level” (NOAEL) can be established at 2500 ppm for animals of either sex (equivalent to a mean achieved dosage of 138.0 mg/kg bw/day for males and 162.9 mg/kg bw/day for females), based on the observed effects. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4daf30cc-3306-493e-9a8c-15b9084cde02/documents/IUC5-1c0bc241-5283-4310-8d1f-095357b0fb64_c36cc23e-24f5-4c91-9491-f7297d8363e8.html,,,,,, 3-methyl-1-benzofuran-5-ol,7182-21-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4daf30cc-3306-493e-9a8c-15b9084cde02/documents/IUC5-1c0bc241-5283-4310-8d1f-095357b0fb64_c36cc23e-24f5-4c91-9491-f7297d8363e8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,138 mg/kg bw/day,,rat 3-methyl-1-benzofuran-5-ol,7182-21-0,"The acute oral toxicity of the test substance, TM 11-0230, was assessed according to OECD Test Guideline 423 using an acute toxic class method. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was approximately 1000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4daf30cc-3306-493e-9a8c-15b9084cde02/documents/IUC5-7891fcbf-0e34-4cd6-9ab4-ab52693aab67_c36cc23e-24f5-4c91-9491-f7297d8363e8.html,,,,,, 3-methyl-1-benzofuran-5-ol,7182-21-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4daf30cc-3306-493e-9a8c-15b9084cde02/documents/IUC5-7891fcbf-0e34-4cd6-9ab4-ab52693aab67_c36cc23e-24f5-4c91-9491-f7297d8363e8.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, 3-methyl-1-isobutylbutyl acetate,10250-45-0," Acute Toxicity: Oral, van Sas (2018) Under the conditions of this study, the acute oral LD50 of the test material was established to exceed 2 000 mg/kg bodyweight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a04a22c-8f89-4434-a455-bb024492a606/documents/a792ba45-f5bb-4a4d-acc7-02b27f15539f_6c42f5c6-2cfc-491a-8662-2a1e80b454ba.html,,,,,, 3-methyl-1-isobutylbutyl acetate,10250-45-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a04a22c-8f89-4434-a455-bb024492a606/documents/a792ba45-f5bb-4a4d-acc7-02b27f15539f_6c42f5c6-2cfc-491a-8662-2a1e80b454ba.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-methyl-1-phenylpyrazol-5-ylamine,1131-18-6," Acute toxicity: oral The acute oral median lethal dose (LD50) of 3-methyl-1-phenylpyrazol-5-ylamine, when administered to rat was found to be 2500 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71fb109b-d1ca-4cb4-b5f0-8d206ff5588b/documents/ef465d9a-4ce8-493c-83ce-635e9e9af3b8_617e6e3e-fb12-4d46-af3c-bf94d15a8358.html,,,,,, 3-methyl-1-phenylpyrazol-5-ylamine,1131-18-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71fb109b-d1ca-4cb4-b5f0-8d206ff5588b/documents/ef465d9a-4ce8-493c-83ce-635e9e9af3b8_617e6e3e-fb12-4d46-af3c-bf94d15a8358.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, 3-methyl-1-vinyl-1H-imidazolium chloride,13474-25-4,"No adverse effects were observed up to the limit dose tested (1000 mg/kg bw/d). Thereby, the following NOAEL (no observed adverse effect level) of the test article analogue 3-Methyl-1-vinyl-1 H-imidazolium methyl sulfate were determined:a) NOAEL for general, systemic toxicity was 1000 mg/kg bw/d for the F0 females and malesb) NOAEL for reproductive performance and fertility was 1000 mg/kg bw/d for the F0 parental rats ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/493ef8fe-d02f-4f0c-8ef9-d6dd102b49ac/documents/IUC5-d659bb3c-e0f6-4653-9605-06c6f792162a_f42abdb7-3a22-4eec-8b5a-8cff0c8604d1.html,,,,,, 3-methyl-1-vinyl-1H-imidazolium chloride,13474-25-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/493ef8fe-d02f-4f0c-8ef9-d6dd102b49ac/documents/IUC5-d659bb3c-e0f6-4653-9605-06c6f792162a_f42abdb7-3a22-4eec-8b5a-8cff0c8604d1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 3-methyl-1-vinyl-1H-imidazolium chloride,13474-25-4,The acute oral LD value of the test material was determined to be 4780 mg/kg bw (combined male and female).The acute dermal LD value ot the test material analogue 3-methyl-1-vinyl-vinylimidazolium methosulfate was determined to be greater than 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/493ef8fe-d02f-4f0c-8ef9-d6dd102b49ac/documents/IUC5-223f344f-f68b-4eeb-bf12-fbbbbda60448_f42abdb7-3a22-4eec-8b5a-8cff0c8604d1.html,,,,,, 3-methyl-1-vinyl-1H-imidazolium chloride,13474-25-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/493ef8fe-d02f-4f0c-8ef9-d6dd102b49ac/documents/IUC5-223f344f-f68b-4eeb-bf12-fbbbbda60448_f42abdb7-3a22-4eec-8b5a-8cff0c8604d1.html,,oral,LD50,"4,780 mg/kg bw",no adverse effect observed, 3-methyl-1-vinyl-1H-imidazolium chloride,13474-25-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/493ef8fe-d02f-4f0c-8ef9-d6dd102b49ac/documents/IUC5-223f344f-f68b-4eeb-bf12-fbbbbda60448_f42abdb7-3a22-4eec-8b5a-8cff0c8604d1.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-methyl-1-vinyl-1H-imidazolium methyl sulphate,26591-72-0,"OECD 422 (BASF SE, 2013): NOAEL = 1000 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a21af940-4941-4421-b88f-24c02c324324/documents/IUC5-05e39731-bee1-4429-86bb-79bc66c8d687_51ba56db-6e41-43e3-bdee-5d0d81910d05.html,,,,,, 3-methyl-1-vinyl-1H-imidazolium methyl sulphate,26591-72-0,"LD50(oral) > 2000 mg/kg (Bioassay, 2012)LD50(dermal) > 2000 mg/kg (Bioassay, 2012) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a21af940-4941-4421-b88f-24c02c324324/documents/IUC5-0f96515d-3974-472d-868d-08b87cc3d972_51ba56db-6e41-43e3-bdee-5d0d81910d05.html,,,,,, 3-methyl-4-phenylbutan-2-ol,56836-93-2,"Muguesia, acute oral toxicity > 2000 mg/kg bw based on read across from Vetikon (OECD TG 401). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfbcb19d-a7b3-4d7f-8000-c898c11370d0/documents/IUC5-c1d9ff8a-2a9c-4f4a-b4cc-0e3496d83396_370e195c-0ee3-4b5a-b35c-b2d7de0904aa.html,,,,,, "3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-one",67801-15-4,Acute Toxicity - Oral and Dermal studies ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b4a21e2-4708-405b-853b-95fb9b30bcfa/documents/IUC5-9acef0da-41a7-4109-81a5-e6510bae333f_86fb4ee6-411d-4cc3-bd21-210a891fd979.html,,,,,, "3-methyl-5-(2,2,3-trimethyl-3-cyclopenten-1-yl)pent-4-en-2-one",67801-15-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b4a21e2-4708-405b-853b-95fb9b30bcfa/documents/IUC5-9acef0da-41a7-4109-81a5-e6510bae333f_86fb4ee6-411d-4cc3-bd21-210a891fd979.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3-methyl-6-(p-toluidino)-3H-dibenz[f,ij]isoquinoline-2,7-dione",81-39-0," A study is available according to OECD TG 407 ""Repeated Dose 28 Day Oral Toxicity Study in Rodents"" (adopted 03 October 2008). The test item was administered by gavage to three groups (Groups 2, 3 and 4), each of five male and five female Wistar Han™:RccHan™:WIST strain rats, for twenty-eight consecutive days (females) and twenty-nine consecutive days (males) at dose levels of 100, 300 and 1000 mg/kg bw/day. A control group (Group 1) of five males and five females was dosed with vehicle alone (Polyethylene glycol 400). Clinical signs, functional observations, body weight change, dietary intake and water consumption were monitored during the study. Hematology and blood chemistry were evaluated for all Group 1 to 4 animals at the end of the study. All animals were subjected to gross necropsy examination and histopathological evaluation of selected tissues from high dose and control animals was performed. In conclusion, a dosage of 1000 mg/kg bw/day (the highest dosage tested) is considered to be the No Observed Adverse Effect Level (NOAEL) for this twenty-eight day toxicity study since no toxicologicalyy significant effects were reported in this guideline study. In addition potential genotoxicity was investigated in this study sub-acute with a Comet test according to OECD TG 489 “In vivo Mammalian Alkaline Comet Assay”. Samples of the liver, glandular stomach and jejunum were taken from male animals and processed to provide single cell suspensions with sufficient numbers of cells for the Comet Assay to detect DNA strand breaks in cells or nuclei. No genotoxic effect was reported; for further information see chapter genetic toxicity in vivo. In aother study according to OECD TG 421 “Reproduction/Developmental Toxicity Screening Test” (adopted 29 July 2016). Ttest item was administered by gavage to three groups, each of twelve male and twelve female Wistar Han™:RccHan™:WIST strain rats, for approximately six weeks (males) and eight weeks (females) (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dose levels of 100, 300 and 1000 mg/kg bw/day. Based on the results of this study, the No Observed Adverse Effect Level (NOAEL) for the adult animals was considered to be 1000 mg/kg bw/day (the highest dosage tested). The No Observed Adverse Effect Level for reproduction and for the growth, development and survival of the offspring was also considered to be 1000 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e25df8a3-86bb-4185-821f-4b0fd4004d26/documents/9895df5e-840f-4606-8fca-25f0f0fe8135_f2740eb2-711d-455b-96be-cfe02bc192e4.html,,,,,, "3-methyl-6-(p-toluidino)-3H-dibenz[f,ij]isoquinoline-2,7-dione",81-39-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e25df8a3-86bb-4185-821f-4b0fd4004d26/documents/9895df5e-840f-4606-8fca-25f0f0fe8135_f2740eb2-711d-455b-96be-cfe02bc192e4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3-methyl-6-(p-toluidino)-3H-dibenz[f,ij]isoquinoline-2,7-dione",81-39-0," Acute oral toxicological investigations were conducted in an old study after administration of Macrolex Red 5B to male Wistar rats. After single administration of 5000 mg/kg no clinical systemic poisoning were observed. No deaths occurred. The male rats sacrificed at the end of the study did not show any noticeable gross pathological findings. The discriminating dose is >1175 mg/m3 in an OECD TG 403 complient recent acute inhalation study. The mean mass median aerodynamic diameter (MMAD) was 11.18 µm and the mean geometric standard deviation (GSD) was 2.24. Animals exposed to the test item did not reveal any clinical symptoms. Nonetheless test-item dependent red discoloration of the fur was observed at the head, forelegs, neck and thorax. No findings were seen at the functional observation battery. No toxicological relevant test item-related changes in incremental body weight gain were observed. Statistically comparisons between the control and the exposure groups revealed no significantly changed body temperatures at 1175 mg/m3 test item when compared to control groups. Mortality did not occur at 1175 mg/m3. No gross pathological findings were found in animals exposed to the test item. In summary, the maximum attainable aerosol concentration was tested in this study. No acute dermal toxicity study is available. Based on the low oral toxicity and no irritation potential to skin or eyes, no dermal toxicity is anticipated. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e25df8a3-86bb-4185-821f-4b0fd4004d26/documents/152006e7-8f05-4978-bc6d-75d28bf021fc_f2740eb2-711d-455b-96be-cfe02bc192e4.html,,,,,, "3-methyl-6-(p-toluidino)-3H-dibenz[f,ij]isoquinoline-2,7-dione",81-39-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e25df8a3-86bb-4185-821f-4b0fd4004d26/documents/152006e7-8f05-4978-bc6d-75d28bf021fc_f2740eb2-711d-455b-96be-cfe02bc192e4.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "3-methyl-6-(p-toluidino)-3H-dibenz[f,ij]isoquinoline-2,7-dione",81-39-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e25df8a3-86bb-4185-821f-4b0fd4004d26/documents/152006e7-8f05-4978-bc6d-75d28bf021fc_f2740eb2-711d-455b-96be-cfe02bc192e4.html,,inhalation,discriminating conc.,"1,175 mg/m3",no adverse effect observed, 3-Methyl-cyclohexanecarboxylic acid methyl ester,7605-52-9,"The acute median lethal oral dose (LD50) to rats of M3MC-Carboxylate was demonstrated to be between 300 and 2000 mg/kg bodyweight.M3MC-Carboxylate is included in Category 4, according to the Globally Harmonised System (GHS), (UNITED NATIONS, 2005). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a5b1c7e-65ac-4b20-8dd3-bdc2573f78ab/documents/IUC5-6e88bf82-0fe8-47ea-bc62-3f9a8fa1b719_00e7afeb-8f0f-40b1-9a23-efdddbd70a95.html,,,,,, 3-methylpentane,96-14-0,"Since no acute toxicity study was performed, the results of a 28-day oral toxicity study in rats with two dose groups (500 and 2000 mg/kg bw/d) of the structurally related read-across substance 2-Methylpentane have been used. The higher dose level is the limit dose normally applied in acute toxicty studies. The LD50 was greater than 2000 mg/kg bw/d, but 3 out of 10 animals died at this dose level in repeated dose testing. Also, 3/10 animals died at the lower dose level of 500 mg/kg bw/d. No mortality was observed in the negative control group. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d309a29f-16e3-4f45-97c9-50d47361df40/documents/68c7ca40-91fe-43ae-bc52-585eaa037dc1_d4e394cd-3ee7-44dc-b618-48ec421e80a0.html,,,,,, 3-methylpentane,96-14-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d309a29f-16e3-4f45-97c9-50d47361df40/documents/68c7ca40-91fe-43ae-bc52-585eaa037dc1_d4e394cd-3ee7-44dc-b618-48ec421e80a0.html,,oral,LD50,"> 2,000 mg/kg bw",adverse effect observed, "3-methylpentane-1,5-diol",4457-71-0,"Suitable data is available for assessing the potential for repeated dose toxicity of the target substance. Based on the results obtained from short-term and sub-chronic repeated dose toxcity studies, no classification for repeated dose toxicity is warranted in accordance with CLP Regulation 1272/2008. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0b4ecff-55fd-4ea8-8cb5-6e2a7237ebe8/documents/IUC5-19c460ce-812f-4d05-a5a9-ed57c8a41f0f_a83fbd42-aebf-4083-a95e-ce8a76c20322.html,,,,,, "3-methylpentane-1,5-diol",4457-71-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0b4ecff-55fd-4ea8-8cb5-6e2a7237ebe8/documents/IUC5-19c460ce-812f-4d05-a5a9-ed57c8a41f0f_a83fbd42-aebf-4083-a95e-ce8a76c20322.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "3-methylpentane-1,5-diol",4457-71-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0b4ecff-55fd-4ea8-8cb5-6e2a7237ebe8/documents/IUC5-19c460ce-812f-4d05-a5a9-ed57c8a41f0f_a83fbd42-aebf-4083-a95e-ce8a76c20322.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3-methylpentane-1,5-diol",4457-71-0,"Suitable data is available to assess the potential of the target substance to induce acute toxicity. Based on the results, it can be concluded that no classification for acute toxicity is warranted in accordance with CLP Regulation (EC) No 1272/2008. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0b4ecff-55fd-4ea8-8cb5-6e2a7237ebe8/documents/IUC5-bba3673d-79c8-42ee-8db4-011f615c661c_a83fbd42-aebf-4083-a95e-ce8a76c20322.html,,,,,, "3-methylpentane-1,5-diol",4457-71-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0b4ecff-55fd-4ea8-8cb5-6e2a7237ebe8/documents/IUC5-bba3673d-79c8-42ee-8db4-011f615c661c_a83fbd42-aebf-4083-a95e-ce8a76c20322.html,,oral,LD50,"8,000 mg/kg bw",adverse effect observed, "3-methylpentane-1,5-diol",4457-71-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0b4ecff-55fd-4ea8-8cb5-6e2a7237ebe8/documents/IUC5-bba3673d-79c8-42ee-8db4-011f615c661c_a83fbd42-aebf-4083-a95e-ce8a76c20322.html,,inhalation,discriminating conc.,70 mg/m3,no adverse effect observed, "3-methyltetrahydrothiophene 1,1-dioxide",872-93-5, Repeated dose toxicity (OECD TG 422): NOAEL > 50 mg/kg bw/day (highest dose tested) ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a7f0701-ba56-4e70-9780-07705736408e/documents/144337f6-cdd9-4c37-8572-f2c62be25eb3_2f3f1302-2557-4ef9-a462-cd07a50b4c28.html,,,,,, "3-methyltetrahydrothiophene 1,1-dioxide",872-93-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a7f0701-ba56-4e70-9780-07705736408e/documents/144337f6-cdd9-4c37-8572-f2c62be25eb3_2f3f1302-2557-4ef9-a462-cd07a50b4c28.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "3-methyltetrahydrothiophene 1,1-dioxide",872-93-5, Acute oral toxicity OECD TG 423: 50 < LD50 < 300 mg/kg bw Acute dermal toxicity OECD TG 402: LD50 >2000 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a7f0701-ba56-4e70-9780-07705736408e/documents/bf107e4c-a170-4186-a8c5-82f02423b338_2f3f1302-2557-4ef9-a462-cd07a50b4c28.html,,,,,, "3-methyltetrahydrothiophene 1,1-dioxide",872-93-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a7f0701-ba56-4e70-9780-07705736408e/documents/bf107e4c-a170-4186-a8c5-82f02423b338_2f3f1302-2557-4ef9-a462-cd07a50b4c28.html,,oral,LD50,50 mg/kg bw,adverse effect observed, 3-methylthiazolidine-2-thione,1908-87-8," Repeated dose toxicity: subchronic (90 day) study oral (feed), rat (Wistar) m/f (similar to OECD 408): NOAEL = 100 ppm corresponding to 7.91 mg/kg bw/d (males) and 9.78 mg/kg bw/d (females) (based on food consumption, body weight) LOAEL = 500 ppm corresponding to 42.70 mg/kg bw/d (males) and 49.54 mg/kg bw/d (females) (based on food consumption, body weight) LOAEL = 2500 ppm corresponding to 202.54 mg/kg bw/d (males) and 228.87 mg/kg bw/d (females) (based on mortality; clinical chemistry; urinalysis) No specific target organ toxicity was identified, no classification as STOT RE Cat. 2 was triggered.   Repeated dose toxicity: subacute (6, 12, and 23 day) study oral (gavage), 50 mg/d, rat (Wistar), male: NOEL ≥ 50 mg/kg/d (male, based on relative / absolute thyroid gland weight) LOEL = 50 mg/kg/d (male, based on body weight)   Repeated dose toxicity: subacute (5 x 4hour exposure) study inhalation (vapour), 2108 resp. 2613 mg/m³, mice, rats, hamsters, and rabbits: NOECs ≥ 2108 mg/m³ air (mice, rats) resp. ≥ 2613 mg/m³ (hamsters, rabbits) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/337b5f2e-011b-46b6-9e63-c960368ddb16/documents/f27fa7d1-20d3-4c72-89bd-1db613fa596b_e695a1c5-6d78-4116-bf7e-305c3b76f36c.html,,,,,, 3-methylthiazolidine-2-thione,1908-87-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/337b5f2e-011b-46b6-9e63-c960368ddb16/documents/f27fa7d1-20d3-4c72-89bd-1db613fa596b_e695a1c5-6d78-4116-bf7e-305c3b76f36c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,7.91 mg/kg bw/day,,rat 3-methylthiazolidine-2-thione,1908-87-8,"Acute oral toxicity: LD50 = 1218 mg/kg bw (males) and 1203 mg/kg bw (females) for rats (similar to OECD 401)Acute dermal toxicity: LD50 > 500 mg/kg, no effects at this dose were seen in rats (similar to OECD 402)Acute inhalation toxicity: LC0 ≥ 600 mg/m³ air (rats, dust), LC0 ≥ 24725 mg/m³ air (mice, rats, vapour), LC0 ≥ 24650 mg/m³ air (hamsters, rabbits, vapour) (similar to OECD 403, 4h exposure)Acute intraperitoneal toxicity: LD50 = 291 mg/kg bw (males) and 253 mg/kg bw (females) (rats, ip injection) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/337b5f2e-011b-46b6-9e63-c960368ddb16/documents/IUC5-21214860-04aa-48b0-973b-98e945060498_e695a1c5-6d78-4116-bf7e-305c3b76f36c.html,,,,,, 3-methylthiazolidine-2-thione,1908-87-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/337b5f2e-011b-46b6-9e63-c960368ddb16/documents/IUC5-21214860-04aa-48b0-973b-98e945060498_e695a1c5-6d78-4116-bf7e-305c3b76f36c.html,,oral,LD50,"1,203 mg/kg bw",adverse effect observed, 4-(4-aminophenyl)morpholin-3-one,438056-69-0,"Oral by gavage, subacute (4 weeks) (Rat-Wistar, GLP, OECD TG 407, EU Method B. 7): NOAEL = 40 mg/kg body weight[Bayer AG, Report No. PH-34876, 2007-04-20] ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/989b3437-962a-48af-bd28-d656f734b394/documents/IUC5-623be54c-a5bb-4198-9e6b-2aec8199e47d_c649ba9f-9baa-4e28-b434-56d1f4c2e786.html,,,,,, 4-(4-aminophenyl)morpholin-3-one,438056-69-0,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/989b3437-962a-48af-bd28-d656f734b394/documents/IUC5-623be54c-a5bb-4198-9e6b-2aec8199e47d_c649ba9f-9baa-4e28-b434-56d1f4c2e786.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat 4-(4-aminophenyl)morpholin-3-one,438056-69-0,"Oral (Rat-Wistar, GLP, OECD TG 423, EU Method B. 1 tris, EPA OPPTS 870.1100): LD50 cut-off >= 5000 mg/kg[Bayer AG, Report No. PH-34725, 2007-01-11] ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/989b3437-962a-48af-bd28-d656f734b394/documents/IUC5-b3a3aee7-0d4c-4ef7-acab-e5011c4e5204_c649ba9f-9baa-4e28-b434-56d1f4c2e786.html,,,,,, 4-(4-Nitrophenyl)-morpholin-3-on,446292-04-2,"Supporting_rel.1_McPhie (2023) Administration of 100, 300 or 1000 mg/kg/day of test item (daily via oral gavage at a volume of 4 mL/mg) to rats for up to 14 days was tolerated in life with no unscheduled deaths. At 1000 mg/kg/day adverse post dose observations of cool to touch (whole body) in three to five females , additionally, decreased general activity, discoloured urine, excessive lacrimation and squinting of eyes were noted. Clinical observations of excessive salivation, discoloured urine and abnormal colour of the pilage were noted in animals administered 1000 mg/kg/day. Based on these results, doses under 1000 mg/kg/day would be considered suitable for longer term studies. Key_rel.1_OECD TG 407_McPhie (2023) Once daily administration of 100, 300, or 750 mg/kg/day test item (via oral gavage at a volume of 4 mL/mg) to rats for up to 28 days, was generally well tolerated inlife with no significant adverse effects at any dose level. Test item-related clinical observations that consisted of excessive salivation and discoloration of the urine and external body surface of animals were noted at all dose levels. Postdose observations of reduced activity and eye closure, mouth rubbing, eye closure, and vocalization were also noted for animals administered ≥300 mg/kg/day. Overall, slightly reduced body weight gain was noted for males administered 300 or 750 mg/kg/day, with associated reduced food consumption. Minor effects on locomotor activity were noted, primarily in the first ten minutes following dosing, for animals administered 300 or 750 mg/kg/day. Microscopically, an increased severity of hyaline droplet accumulation in the kidney of males and increased extramedullary hematopoiesis in the spleen of females were noted for animals administered 750 mg/kg/day. Due to low severity and lack of any detrimental impact on the health and well-being of animals, these findings were considered not adverse. Thus, the no observed adverse effect level (NOAEL) is considered 750 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ae674de-2525-46bd-aa3d-daa2f813de35/documents/7b07b097-37c9-4697-9cb5-1941afe554c8_ada3b323-02ae-437f-be1b-e7d0057dbeab.html,,,,,, 4-(4-Nitrophenyl)-morpholin-3-on,446292-04-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ae674de-2525-46bd-aa3d-daa2f813de35/documents/7b07b097-37c9-4697-9cb5-1941afe554c8_ada3b323-02ae-437f-be1b-e7d0057dbeab.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat 4-(4-Nitrophenyl)-morpholin-3-on,446292-04-2,"Acute toxicity: oral (rats, OECD TG 423): LD50: > 2000 mg/kg b.w. The acute oral toxicity to female Wistar rats of 4-(4-Nitrophenyl)-3-morpholinon was assessed. The test compound was formulated in tap water with the aid of 2% Cremophor EL, the administration volume was 10 ml/kg body weight. The starting dose of the test item was 2000 mg/kg b.w.. According to the OECD guideline 423 the LD50 of the test item is > 2000 mg/kg b.w..   Acute toxicity: dermal (rats, OECD TG 402): LD50: > 2000 mg/kg b.w. The study was performed to asses the acute dermal toxicity of 4-(4-Nitrophenyl)-3-morpholinone in female SD rats according to the OECD guideline 402.The single dermal administration of the test substance to the rats at a dose of 2000 mg/kg b.w. was tolerated without any mortality or compound-related clinical or macroscopic pathological signs.The LD50 acute dermal toxicity in female SD rats was estimated to be > 2000 mg/kg b.w.. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ae674de-2525-46bd-aa3d-daa2f813de35/documents/IUC5-94fbf168-a686-4fb3-8858-ff26f264b5ff_ada3b323-02ae-437f-be1b-e7d0057dbeab.html,,,,,, 4-(4-Nitrophenyl)-morpholin-3-on,446292-04-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ae674de-2525-46bd-aa3d-daa2f813de35/documents/IUC5-94fbf168-a686-4fb3-8858-ff26f264b5ff_ada3b323-02ae-437f-be1b-e7d0057dbeab.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 4-(4-Nitrophenyl)-morpholin-3-on,446292-04-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ae674de-2525-46bd-aa3d-daa2f813de35/documents/IUC5-94fbf168-a686-4fb3-8858-ff26f264b5ff_ada3b323-02ae-437f-be1b-e7d0057dbeab.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4-{4-[(5S)-5-(aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one hydrochloride",898543-06-1,"Oral (Rat-Wistar, GLP, OECD TG 423, EU Method B. 1 tris, EPA OPPTS 870.1100): LD50 > 2000 mg/kg [Bayer AG, Report No. PH-33257, 2004-04-01]   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4011cbf9-71ed-4888-8de8-111e874db402/documents/IUC5-7ba99fbf-e41c-4c47-bf4c-2eb6ea9f7d85_fbe84e8b-5729-40bf-adbc-256d7c5d8b25.html,,,,,, "4-{4-[(5S)-5-(aminomethyl)-2-oxo-1,3-oxazolidin-3-yl]phenyl}morpholin-3-one hydrochloride",898543-06-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4011cbf9-71ed-4888-8de8-111e874db402/documents/IUC5-7ba99fbf-e41c-4c47-bf4c-2eb6ea9f7d85_fbe84e8b-5729-40bf-adbc-256d7c5d8b25.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 3-morpholinopropylamine,123-00-2," Repeated dose toxicity - Oral:  A Key, K1 28 -day repeated dose toxicity study was performed in rats according to OECD guideline 407 (GLP-compliant) (Malleshappa HN , 2020). A NOAEL of 500 mg/kg bw/day was derived for male and female systemic toxicity. Repeated dose toxicity - Inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Repeated dose toxicity - Dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6eb5edee-e45b-4b35-87bf-08d97d4b482f/documents/be108494-d1a1-4d62-a4ea-d3cf8079ffd1_3971abae-fec3-41de-bf0a-26038483a61d.html,,,,,, 3-morpholinopropylamine,123-00-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6eb5edee-e45b-4b35-87bf-08d97d4b482f/documents/be108494-d1a1-4d62-a4ea-d3cf8079ffd1_3971abae-fec3-41de-bf0a-26038483a61d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat 3-morpholinopropylamine,123-00-2,"Acute toxicity - oral: A key, K1 acute oral toxicity test was performed in male and female Sprague Dawley rats equivalent to OECD Guideline 401 (Mallory, 1992). The calculated acute oral LD50 for combined sexes was determined to be 1790.9 mg/kg.  Acute toxicity - inhalation: An acute inhalation study does not need to be conducted as the substance is classified as corrosive to the skin (according to REACH Annex VIII section 8.5, column 2). In addition, reliable acute oral and acute dermal toxicity studies with the test substance are available. Acute toxicity - dermal: A K1 acute dermal toxicity test was performed in male and female New Zealand White rabbits similar to OECD Guideline 402 (Mallory, 1993). The dermal LD50 in males, females and combined sexes was determined to be 2219.7, 2396.1 and 2297.9 mg/kg respectively.  ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6eb5edee-e45b-4b35-87bf-08d97d4b482f/documents/4396711a-9e4a-48d6-ae72-69a3a81b325b_3971abae-fec3-41de-bf0a-26038483a61d.html,,,,,, 3-morpholinopropylamine,123-00-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6eb5edee-e45b-4b35-87bf-08d97d4b482f/documents/4396711a-9e4a-48d6-ae72-69a3a81b325b_3971abae-fec3-41de-bf0a-26038483a61d.html,,oral,LD50,"1,790.9 mg/kg bw",adverse effect observed, 3-morpholinopropylamine,123-00-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6eb5edee-e45b-4b35-87bf-08d97d4b482f/documents/4396711a-9e4a-48d6-ae72-69a3a81b325b_3971abae-fec3-41de-bf0a-26038483a61d.html,,dermal,LD50,"2,297.9 mg/kg bw",adverse effect observed, 3'-nitroacetophenone,121-89-1, Acute oral toxicity:L D50 was considered to be 3250 mg/kg bw when Carworth Wistar male rat were treated with 3'-Nitroacetophenone orally by gavage. Acute dermal toxicity: LD50 was considered to be 3756 mg/kg bw when rabbits were treated with 3'-Nitroacetophenone by dermal application. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfb4ffac-7ef0-47a1-9cd2-975ff25e2908/documents/976e6bf8-0c3e-4bfc-a4bc-ce49747717b7_a545b061-5046-435c-8c8f-f6c1ce0490db.html,,,,,, 3'-nitroacetophenone,121-89-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfb4ffac-7ef0-47a1-9cd2-975ff25e2908/documents/976e6bf8-0c3e-4bfc-a4bc-ce49747717b7_a545b061-5046-435c-8c8f-f6c1ce0490db.html,,oral,LD50,"3,250 mg/kg bw",no adverse effect observed, 3'-nitroacetophenone,121-89-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfb4ffac-7ef0-47a1-9cd2-975ff25e2908/documents/976e6bf8-0c3e-4bfc-a4bc-ce49747717b7_a545b061-5046-435c-8c8f-f6c1ce0490db.html,,dermal,LD50,"3,756 mg/kg bw",no adverse effect observed, 3-nitrobenzoic acid,121-92-6," Repeated dose toxicity: Oral The no-observed- adverse-effect-level (NOAEL) for male rats was considered to be 20 mg/kg/day and NOAEL for female rats was considered to be 100 mg/kg/day when Crl:CD (SD) male and female rat were treated with test substance. Repeated dose toxicity: Inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 3-Nitrobenzoic acid (121-92-6) which is reported as 0.0000371 mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical 3-Nitrobenzoic acid (121-92-6) is highly unlikely. Therefore this study is considered for waiver. Repeated dermal study; The acute toxicity value for 3-Nitrobenzoic acid (121-92-6) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 3-Nitrobenzoic acid shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 3-Nitrobenzoic acid shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30487e60-9707-457b-a887-931fd9338e1d/documents/8bf96685-6854-4afa-87a2-1cfe6c518854_4c768817-88cf-4b35-9958-b5d5ebc98413.html,,,,,, 3-nitrobenzoic acid,121-92-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30487e60-9707-457b-a887-931fd9338e1d/documents/8bf96685-6854-4afa-87a2-1cfe6c518854_4c768817-88cf-4b35-9958-b5d5ebc98413.html,Chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 3-nitrobenzoic acid,121-92-6," Acute oral toxicity:  Acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the given test chemical. The LD50 value was considered is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  The acute toxicity inhalation study need not be conducted because exposure to humans via inhalation route is not likely taking into account the low vapour pressure of the substance, which is reported as 0.0000371 mm Hg at 25°C. Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely. Therefore this study is considered for waiver. Acute Dermal toxicity:  The acute dermal toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30487e60-9707-457b-a887-931fd9338e1d/documents/7a3d3a91-4e76-4363-9be3-ef72df458ebf_4c768817-88cf-4b35-9958-b5d5ebc98413.html,,,,,, 3-nitrobenzoic acid,121-92-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30487e60-9707-457b-a887-931fd9338e1d/documents/7a3d3a91-4e76-4363-9be3-ef72df458ebf_4c768817-88cf-4b35-9958-b5d5ebc98413.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-nitrobenzoic acid,121-92-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30487e60-9707-457b-a887-931fd9338e1d/documents/7a3d3a91-4e76-4363-9be3-ef72df458ebf_4c768817-88cf-4b35-9958-b5d5ebc98413.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-nitrotoluene,99-08-1,"Acute oral toxicity, OECD 401 eq. (Key, rel.2, Bayer, 1976), LD50: 2121 mg/kg bw (male) / 1784 mg/kg bw (female) Acute inhalation toxicity, OECD 403 eq. (rel.2, Kinkead, 1977), LD50: > 880 mg/m3 Acute dermal toxicity, OECD 402 eq. (rel.2, Bayer, 1976), LD50: > 1157 mg/kg bw Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): A Klimisch rating of 2 has been applied. The study is pre-GLP but conducted to a relevant OECD test guideline using well-defined scientific procedures, therefore fulfilling the endpoint requirement. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18deac2e-b20b-4eb7-8b11-eda5b5de8e59/documents/8db828d8-6275-442c-9b64-12e2b89252e8_272ef00e-083d-4417-826c-fa5c0cd03789.html,,,,,, 3-nitrotoluene,99-08-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18deac2e-b20b-4eb7-8b11-eda5b5de8e59/documents/8db828d8-6275-442c-9b64-12e2b89252e8_272ef00e-083d-4417-826c-fa5c0cd03789.html,,oral,LD50,">=1,784 mg/kg bw",adverse effect observed, "2-[2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethanol",28770-01-6, The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be in the range of 300 - 2000 mg/kg bodyweight. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f76351b-86c9-4349-bfac-edfaeb2601a3/documents/0ee0b3f4-9849-402f-b73e-07bb053a5d66_c3ddbe10-51e0-4bdd-9780-a32393d04465.html,,,,,, "2-[2-(propan-2-yl)-1,3-oxazolidin-3-yl]ethanol",28770-01-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f76351b-86c9-4349-bfac-edfaeb2601a3/documents/0ee0b3f4-9849-402f-b73e-07bb053a5d66_c3ddbe10-51e0-4bdd-9780-a32393d04465.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "3-phenyl-7-[4-(tetrahydrofurfuryloxy)phenyl]-1,5-dioxa-s-indacen-2,6-dione",134724-55-3,"The acute oral LD50 of FAT 40554 in rats is greater than 5000 mg/kg and the acute dermal LD50 in rabbits is greater than 2000 mg/kg. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Good quality database with klimisch rating 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Good quality databased with klimisch rating 1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5851276f-9bcf-47cd-8d2f-78984550397d/documents/IUC5-8b58dfc8-c97a-482c-8a50-d23e6e44b00f_cdd42582-f59f-469e-ab1c-221b7fd3a6eb.html,,,,,, "3-phenyl-7-[4-(tetrahydrofurfuryloxy)phenyl]-1,5-dioxa-s-indacen-2,6-dione",134724-55-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5851276f-9bcf-47cd-8d2f-78984550397d/documents/IUC5-8b58dfc8-c97a-482c-8a50-d23e6e44b00f_cdd42582-f59f-469e-ab1c-221b7fd3a6eb.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3-phenyl-7-[4-(tetrahydrofurfuryloxy)phenyl]-1,5-dioxa-s-indacen-2,6-dione",134724-55-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5851276f-9bcf-47cd-8d2f-78984550397d/documents/IUC5-8b58dfc8-c97a-482c-8a50-d23e6e44b00f_cdd42582-f59f-469e-ab1c-221b7fd3a6eb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-phenylpropionyl chloride,645-45-4," Acute oral toxicity: LD50 was considered to be 2168mg/kg whenrats were treated with 3 phenylpropionyl chloride(645-45-4),orally.      Acute inhalation toxicity: LC50 was considered to be 2750 mg/m3/hwhen rats were treated with3 phenylpropionyl chloride(645-45-4), by inhalation for 4 hours.   Acute dermal toxicity:  LD50 was considered to be 2278mg/kg bw when rats were treated with 3 phenylpropionyl chloride(645-45-4), on dermal application.   ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c57cd421-501c-44c9-b84f-1c4b10d21d42/documents/10927a0f-b60f-4c90-9134-f036ed5eefcf_0903d5bf-8ffa-4bad-ac4c-0bf099cc0c6c.html,,,,,, 3-phenylpropionyl chloride,645-45-4,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c57cd421-501c-44c9-b84f-1c4b10d21d42/documents/10927a0f-b60f-4c90-9134-f036ed5eefcf_0903d5bf-8ffa-4bad-ac4c-0bf099cc0c6c.html,,oral,LD50,"2,168 mg/kg bw",no adverse effect observed, 3-phenylpropionyl chloride,645-45-4,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c57cd421-501c-44c9-b84f-1c4b10d21d42/documents/10927a0f-b60f-4c90-9134-f036ed5eefcf_0903d5bf-8ffa-4bad-ac4c-0bf099cc0c6c.html,,dermal,LD50,"2,278 mg/kg bw",no adverse effect observed, 3-phenylpropionyl chloride,645-45-4,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c57cd421-501c-44c9-b84f-1c4b10d21d42/documents/10927a0f-b60f-4c90-9134-f036ed5eefcf_0903d5bf-8ffa-4bad-ac4c-0bf099cc0c6c.html,,inhalation,LC50,"2,750 mg/m3",no adverse effect observed, "(3R,4R)-N,4-Dimethyl-1-(phenylmethyl)-3-piperidinamine dihydrochloride",1062580-52-2,"Repeated dose oral:A repeated dose oral study (Dhinsa N K and Brooks P, 2008) was available which was of limited duration and hence is considered to be a supporting study. This study showed that Lowest Observed Adverse Effect Level (LOAEL) for the test substance is 150 mg/kg/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4999553f-89d0-4d2f-9a69-a0b02c46b758/documents/IUC5-f9102467-b873-49e0-bd06-66a723e83a43_722b633f-f2c9-4284-ac44-d2871b950d5c.html,,,,,, "(3R,4R)-N,4-Dimethyl-1-(phenylmethyl)-3-piperidinamine dihydrochloride",1062580-52-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4999553f-89d0-4d2f-9a69-a0b02c46b758/documents/IUC5-f9102467-b873-49e0-bd06-66a723e83a43_722b633f-f2c9-4284-ac44-d2871b950d5c.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,150 mg/kg bw/day,,rat "(3R,4R)-N,4-Dimethyl-1-(phenylmethyl)-3-piperidinamine dihydrochloride",1062580-52-2,"There was no acute toxicity report, but some information from repeated dose toxicity (Dhinsa N K and Brooks P, 2008) is considered as relevant to classification ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4999553f-89d0-4d2f-9a69-a0b02c46b758/documents/IUC5-26e3a6ec-7bd6-439a-b4e6-85d8a33a1b73_722b633f-f2c9-4284-ac44-d2871b950d5c.html,,,,,, "4-Methyl-2,6-bis-p-tolylamino-5-(2-trifluoromethyl-phenylazo)-nicotinonitrile",669005-94-1,"In a GLP-compliant subacute toxicity study, the test item as described in section 1.2 was administered daily by oral gavage to SPF-bred Wistar rats of both sexes at dose levels of 50, 200 and 1000 mg/kg bw/day for a period of 28 days according to OECD guideline No. 407. 1000 mg/kg bw/day of the test item was considered to be the no-observed-effect-level (NOEL) (RCC 2004) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/436cafb4-616a-4775-b080-9ec629565096/documents/IUC5-59b2ba52-10f1-47fb-8853-1aff8af96f7f_0cfb4c5a-35c9-4d70-9ed7-a6a76c445aed.html,,,,,, "4-Methyl-2,6-bis-p-tolylamino-5-(2-trifluoromethyl-phenylazo)-nicotinonitrile",669005-94-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/436cafb4-616a-4775-b080-9ec629565096/documents/IUC5-59b2ba52-10f1-47fb-8853-1aff8af96f7f_0cfb4c5a-35c9-4d70-9ed7-a6a76c445aed.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4-Methyl-2,6-bis-p-tolylamino-5-(2-trifluoromethyl-phenylazo)-nicotinonitrile",669005-94-1,No mortality was observed in acute oral and dermal toxicity studies in rats after with 2000 mg/kg bw. The studies were performed according to OECD testing guidelines 423 and 402 and under GLP (RCC 2003). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/436cafb4-616a-4775-b080-9ec629565096/documents/IUC5-2b91f819-8c57-4f49-827d-d9565d63b091_0cfb4c5a-35c9-4d70-9ed7-a6a76c445aed.html,,,,,, 3-pyridyl dimethylcarbamate,51581-32-9, GLP guideline study according to OECD 401 ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ab6386a-a15c-4c54-aff4-c31de3fc9adf/documents/06bc3720-008b-42fd-9b4b-4b092a09f409_658d61fc-36d6-4821-a174-797f802416a7.html,,,,,, 3-pyridyl dimethylcarbamate,51581-32-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ab6386a-a15c-4c54-aff4-c31de3fc9adf/documents/06bc3720-008b-42fd-9b4b-4b092a09f409_658d61fc-36d6-4821-a174-797f802416a7.html,,oral,LD50,99.4 mg/kg bw,adverse effect observed, (4Z)-3-ammoniomethyl-4-(methoxyimino)pyrrolidinium dimethanesulfonate,329181-36-4,"OECD guideline for testing of chemicals, TG420 (2001) acute oral toxicity - fixed dose procedureSingle oral gavageSprague-Dawley female ratsMortality, clinical signs and body weight changes for 14 days were monitored and gross pathology for all animals was examined. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81dea00b-9250-44b2-adab-df3663979946/documents/IUC5-f9f26ac8-727f-497a-b604-6dde4a4cb50a_cb3a09b3-f05c-4e4d-be57-9d610b516f36.html,,,,,, (4Z)-3-ammoniomethyl-4-(methoxyimino)pyrrolidinium dimethanesulfonate,329181-36-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81dea00b-9250-44b2-adab-df3663979946/documents/IUC5-f9f26ac8-727f-497a-b604-6dde4a4cb50a_cb3a09b3-f05c-4e4d-be57-9d610b516f36.html,,oral,LD50,"2,000 mg/kg bw",, "7-[(4aS,7aS)-1,2,4a,5,7,7a-hexahydropyrrolo[3,4-b]pyridin-6-yl]-1-cyclopropyl-6,8-difluoro-4-oxo-3H-quinoline-3-carboxylic acid",151213-15-9,"Oral (Rat-Wistar, GLP, OECD TG 423, EU Method B. 1 tris): LD50 > 2000 mg/kg[Bayer AG, Report No. PH 26539, 1997-08-14] ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/477ef313-ff77-4c26-8799-7daf223aaae3/documents/IUC5-3e0711e1-f827-4926-b6ad-e653ac346290_d9104c77-255e-4a2f-8266-8872584c896a.html,,,,,, "3-Quinolinecarboxylic acid, 7-[6-(benzoylmethylamino)-5-methyl-3-pyridinyl]-1-cyclopropyl-1,4-dihydro-8-methyl-4-oxo-, ethyl ester",446299-90-7," Acute oral toxicity: Key study. Test method according to OECD 420, GLP study. The LD50 of the test item is higher than 2000 mg/ kg body weight by oral route in the rat. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4c47ca8-e005-4eff-b155-a04e4e964438/documents/602de603-c0f9-4f9f-bed2-414d91e2f6b9_975c2005-038a-4047-bd70-e96f4930467e.html,,,,,, "3-Quinolinecarboxylic acid, 7-[6-(benzoylmethylamino)-5-methyl-3-pyridinyl]-1-cyclopropyl-1,4-dihydro-8-methyl-4-oxo-, ethyl ester",446299-90-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4c47ca8-e005-4eff-b155-a04e4e964438/documents/602de603-c0f9-4f9f-bed2-414d91e2f6b9_975c2005-038a-4047-bd70-e96f4930467e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-Quinolinecarboxylic acid, 7-chloro-1-cyclopropyl-1,4-dihydro-8-methyl-4-oxo-, ethyl ester",103877-51-6," Acute oral toxicity: Key study. Test method according to OECD 420, GLP study. The LD50 of the test item is higher than 50 mg/ kg body weight  and lower than 300 mg/kg body weight by oral route in the rat. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6de3702c-758f-45ce-b33e-d9d05a646637/documents/0de2a019-8b3a-416c-87bc-bfe90e56424c_49d70b59-f54f-4c7a-8921-0bad977c473c.html,,,,,, "3-Quinolinecarboxylic acid, 7-chloro-1-cyclopropyl-1,4-dihydro-8-methyl-4-oxo-, ethyl ester",103877-51-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6de3702c-758f-45ce-b33e-d9d05a646637/documents/0de2a019-8b3a-416c-87bc-bfe90e56424c_49d70b59-f54f-4c7a-8921-0bad977c473c.html,,oral,LD50,50 mg/kg bw,adverse effect observed, 3-tert-butyladipic acid,10347-88-3," Based on the results of the acute oral toxicity study (Acute Toxic Class Method) with 3-tert-butyladipic acid an LD50 between 300 and 2000 mg/kg bw could be derived (TOXI-COOP, 2017). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b13e68f1-0030-456e-b3f0-7d2f07b3599e/documents/351b6034-3a78-44af-90de-d7e3c641e79a_f54b7cd7-cd14-45f7-a779-78d3781fdc41.html,,,,,, 3-tert-butyladipic acid,10347-88-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b13e68f1-0030-456e-b3f0-7d2f07b3599e/documents/351b6034-3a78-44af-90de-d7e3c641e79a_f54b7cd7-cd14-45f7-a779-78d3781fdc41.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "3α,7α-dihydroxy-12-oxo-5β-cholan-24-oic acid",2458-08-4,The repeated oral toxicity of 12-ketochenodeoxycholic acid has been evaluated basing on aread-across approach with ursodeoxycholic acid. The substance was tested in a 26-week study (1987). No Guideline or followed method is available in the source RTECS. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/196d4f04-6c84-458c-bd81-12926bab4a9d/documents/IUC5-c6af5e94-b822-46bf-bebe-07df8ef7ad93_5f909975-efa0-48ce-a1da-e9f95655a60d.html,,,,,, "3α,7α-dihydroxy-12-oxo-5β-cholan-24-oic acid",2458-08-4,The experimental oral LD50 in rats is 4600 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/196d4f04-6c84-458c-bd81-12926bab4a9d/documents/IUC5-dcc76821-ad21-47c1-83ba-48946b58c8d0_5f909975-efa0-48ce-a1da-e9f95655a60d.html,,,,,, "3α,7α-dihydroxy-12-oxo-5β-cholan-24-oic acid",2458-08-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/196d4f04-6c84-458c-bd81-12926bab4a9d/documents/IUC5-dcc76821-ad21-47c1-83ba-48946b58c8d0_5f909975-efa0-48ce-a1da-e9f95655a60d.html,,oral,LD50,"4,600 mg/kg bw",no adverse effect observed, "3β,21-dihydroxy-16α-methylpregn-5-en-20-one 21-acetate",1173-09-7,"LD50 oral (rat): > 2000 mg/kg bw [Draft report, Kurth 1996]LD50 dermal (rat): > 2000 mg/kg bw [Draft report, Treher and Kurth 1996] ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3355e34f-5079-405a-87fb-a7fd4e4fcfa6/documents/IUC5-78b579bc-f5e4-43a2-807e-c781296b12f3_bf4d9a3d-857d-4735-9d4f-c768ab20c5c8.html,,,,,, "3β,21-dihydroxy-16α-methylpregn-5-en-20-one 21-acetate",1173-09-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3355e34f-5079-405a-87fb-a7fd4e4fcfa6/documents/IUC5-78b579bc-f5e4-43a2-807e-c781296b12f3_bf4d9a3d-857d-4735-9d4f-c768ab20c5c8.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3β,21-dihydroxy-16α-methylpregn-5-en-20-one 21-acetate",1173-09-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3355e34f-5079-405a-87fb-a7fd4e4fcfa6/documents/IUC5-78b579bc-f5e4-43a2-807e-c781296b12f3_bf4d9a3d-857d-4735-9d4f-c768ab20c5c8.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 3β-hydroxyandrost-5-en-17-one acetate,853-23-6," Repeated dose toxicity - oral: No reliable, key repeated dose toxicity study is available for T008506. Therefore, reliable data from the supporting substance Dehydroepiandrosterone (DHEA) is used to cover this endpoint. In a one-year, chronic toxicity study in cynomolgus monkey, an NOAEL of 10 mg/kg/d was established. This NOAEL is also considered valid for the target substance T008506. Based on the results and the CLP Regulation, the substance is not to be classified as STOT RE. Repeated dose toxicty - inhalation: A key study is available for the oral route of exposure. According to the REACH regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Repeated dose toxicty - dermal: A key study is available for the oral route of exposure. According to the REACH regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d2ef1b5-01ef-49d8-96b3-38f819bf9770/documents/30a88856-23ee-483f-a174-a92dc06a9f44_0e4e9656-0c10-481a-8c63-79fa9c85d348.html,,,,,, 3β-hydroxyandrost-5-en-17-one acetate,853-23-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d2ef1b5-01ef-49d8-96b3-38f819bf9770/documents/30a88856-23ee-483f-a174-a92dc06a9f44_0e4e9656-0c10-481a-8c63-79fa9c85d348.html,Chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,monkey 3β-hydroxyandrost-5-en-17-one acetate,853-23-6," Acute toxicity: Oral In an acute oral toxicity study in female Wistar rats, following the acute toxic class method in accordance with the OECD Guideline 423, the LD50 was established to be greater than 2000 mg/kg (van Sas 2018). Acute toxicity: Inhalation In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For this substance, a study was considered however not deemed scientifically justified for the dermal route of exposure due to its low potential for a significant rate of absorption through the skin. Based on the fact that the inhalation route of exposure is not considered relevant in the risk assessment for human exposure and the addition of a waiver for the acute dermal toxicity testing, an acute inhalation toxicity study will not be performed.  Acute toxicity: Dermal In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For this substance, an acute dermal toxicity study was considered. However, this can be waived based on the fact that the substance does not meet the criteria for classification for acute toxicity or STOT SE by the oral route, and no systemic toxicity is observed in in vivo studies with dermal exposure. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d2ef1b5-01ef-49d8-96b3-38f819bf9770/documents/a283a827-ded7-428d-b379-ff78b51647f2_0e4e9656-0c10-481a-8c63-79fa9c85d348.html,,,,,, 3β-hydroxyandrost-5-en-17-one acetate,853-23-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d2ef1b5-01ef-49d8-96b3-38f819bf9770/documents/a283a827-ded7-428d-b379-ff78b51647f2_0e4e9656-0c10-481a-8c63-79fa9c85d348.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-({[4-(acryloyloxy)butoxy]carbonyl}oxy)benzoic acid,297132-04-8,"A crude form of the substance showed no acute oral toxicity in rats. The dose as adjusted for the content is slightly lower than the limit dose of 2000 mg/kg bw. Since no moratlity occurred, it is not expected that the LD50 is lower than 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d03c643-e764-4b94-a758-f761b704f399/documents/IUC5-e73ad7be-523b-43b0-aae0-b8d5ae0a38ae_2f97cf06-502e-4d25-962a-ffebe590843a.html,,,,,, 4-({[4-(acryloyloxy)butoxy]carbonyl}oxy)benzoic acid,297132-04-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d03c643-e764-4b94-a758-f761b704f399/documents/IUC5-e73ad7be-523b-43b0-aae0-b8d5ae0a38ae_2f97cf06-502e-4d25-962a-ffebe590843a.html,,oral,discriminating dose,"1,320 mg/kg bw",no adverse effect observed, "4-(1,1,3,3-tetramethylbutyl)phenol",140-66-9,"In a subchronic guideline study similar to OECD 408 (Bayer (1982) T7010745), 20 Wistar rats/sex/dose were exposed to 0, 30, 300, 3000 ppm 4-(1,1,3,3-tetramethylbutyl)phenol (OCT) for 90 days. The dose equals 0, 2, 23, 228 mg/kg bw/day in males based on the average bw (week 1-13). In a subacute GLP guideline study according to OECD 407 (Huntington Research centre (1994) SAZ 464/9424419), OCT was administered to 5 SD rats/sex/dose at 0, 15, 150, and 300 mg/kg bw/day by gavage. A similar GLP study was conducted according to a Japanese ""Guidelines for 28-Day Repeated Dose Toxicity Test of Chemicals"", using 6 SD rats/sex/dose at 0, 15, 70, and 300 mg/kg bw/day (Matsuura 1992). The study is in Japanese. Only abstract and tables are translated into English. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6be4b373-b5f2-450c-b354-f77fa6b3d6fc/documents/IUC5-65582d34-fa4a-4108-b5a1-76f40d424442_b1932e39-a134-4b7c-92a9-00c8cb88e2b7.html,,,,,, "4-(1,1,3,3-tetramethylbutyl)phenol",140-66-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6be4b373-b5f2-450c-b354-f77fa6b3d6fc/documents/IUC5-65582d34-fa4a-4108-b5a1-76f40d424442_b1932e39-a134-4b7c-92a9-00c8cb88e2b7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,22.5 mg/kg bw/day,,rat "4-(1,1,3,3-tetramethylbutyl)phenol",140-66-9,"A reliable acute oral toxicity study according OECD 401 was conducted in 5 Wistar rats/sex at doses of 3160, 3980, 4495 and 5010 mg/kg bw 4-(1,1,3,3-tetramethylbutyl)phenol in paraffin (Sasol, 1984). A second OECD 401 study was conducted in 5 SD rats/sex at a limit dose of 2000 mg/kg in arachis oil (Safepharm Laboratories 1991). In addition a poorly documented study from Rohm & Haas (1973) reports the oral exposure of 6 albino rats/sex to a limit dose of 5g/kg bw.In a poorly documented inhalation study 6 albino rabbits were exposed to 116 mg/l octylphenol in isopropyl myristate (Rohm & Haas, 1973). The same study investigated acute dermal toxicity using 6 rabbits (3 intact and 3 abraded). Octylphenol was administered at a limit dose of 2.0 g/kg bw. Dermal toxicity was also assessed in an OECD 402 study (BASF 1981) at doses of 1000 and 2000 mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6be4b373-b5f2-450c-b354-f77fa6b3d6fc/documents/IUC5-b844f9e9-0d0f-4859-a9bf-6bd0ea1123f8_b1932e39-a134-4b7c-92a9-00c8cb88e2b7.html,,,,,, "4-(1,1,3,3-tetramethylbutyl)phenol",140-66-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6be4b373-b5f2-450c-b354-f77fa6b3d6fc/documents/IUC5-b844f9e9-0d0f-4859-a9bf-6bd0ea1123f8_b1932e39-a134-4b7c-92a9-00c8cb88e2b7.html,,oral,LD50,"4,040 mg/kg bw",no adverse effect observed, "4-(1,1,3,3-tetramethylbutyl)phenol",140-66-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6be4b373-b5f2-450c-b354-f77fa6b3d6fc/documents/IUC5-b844f9e9-0d0f-4859-a9bf-6bd0ea1123f8_b1932e39-a134-4b7c-92a9-00c8cb88e2b7.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4-(1,1-dimethylethyl)cyclohexyl acrylate",84100-23-2,"OECD 422: NOAEL = 150 mg/kg - taken as POD for Risk Assessment, since relevant (transient) effects were likely missed in the OECD 408 due to differing observation schedules. OECD 408: NOAEL = 500 mg/kg ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cea601be-eeef-4ce9-a6c1-caaa3cbed487/documents/IUC5-e30c5148-f6e0-440e-8b26-42542f686201_56efc67d-8d2d-4ed3-8bb1-54afaa1cbea8.html,,,,,, "4-(1,1-dimethylethyl)cyclohexyl acrylate",84100-23-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cea601be-eeef-4ce9-a6c1-caaa3cbed487/documents/IUC5-e30c5148-f6e0-440e-8b26-42542f686201_56efc67d-8d2d-4ed3-8bb1-54afaa1cbea8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "4-(1,1-dimethylethyl)cyclohexyl acrylate",84100-23-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): well-documented, scientifically acceptable study report ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cea601be-eeef-4ce9-a6c1-caaa3cbed487/documents/IUC5-82187863-64f9-4460-9c8f-5e6e1cffad21_56efc67d-8d2d-4ed3-8bb1-54afaa1cbea8.html,,,,,, "4-(1,1-dimethylethyl)cyclohexyl acrylate",84100-23-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cea601be-eeef-4ce9-a6c1-caaa3cbed487/documents/IUC5-82187863-64f9-4460-9c8f-5e6e1cffad21_56efc67d-8d2d-4ed3-8bb1-54afaa1cbea8.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "4-(1,1-dimethylethyl)cyclohexyl acrylate",84100-23-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cea601be-eeef-4ce9-a6c1-caaa3cbed487/documents/IUC5-82187863-64f9-4460-9c8f-5e6e1cffad21_56efc67d-8d2d-4ed3-8bb1-54afaa1cbea8.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4-(1,1-dimethylethyl)cyclohexyl methacrylate",46729-07-1," The oral administration of 4-(1,1-dimethylethyl)cyclohexyl methacrylate (CAS 46729-07-1) to rats for a period of up to eight weeks (including two weeks pre-pairing, gestation and early lactation for females) at dose levels 50, 150 and 450 mg/kg bw/day resulted in treatment related effects in animals of either sex treated with 450 mg/kg bw/day and in males treated with 150 and 50 mg/kg bw/day.  These included reduced initial body weight gains in either sex at 450 mg/kg bw/day, reduced food consumption in females at 450 mg/kg bw/day, organ weight changes in males at 450 mg/kg bw/day, macroscopic changes in males at 450 mg/kg bw/day and microscopic changes in males at 450, 150 and 50 mg/kg bw/day.  A ‘No Observed Effect Level’ (NOEL) for systemic toxicity was therefore not established for males but was considered to be 150 mg/kg bw/day for females.  The ‘No Observed Adverse Effect Level’ (NOAEL) for females was also considered to be 150 mg/kg bw/day. Although the kidney findings of tubular basophilia and proteinaceous casts in male kidneys could be considered an adverse effect, these findings were considered to be associated with alpha 2u-globulin and formation of hyaline droplets, an effect recognized as being both species and sex specific and not relevant for humans.  In terms of risk assessment, these findings observed on this study would suggest that a ‘No Observed Adverse Effect Level’ (NOAEL) can be established at 150 mg/kg bw/day for males because the findings do not reflect true systemic toxicity. The ‘No Observed Effect Level’ (NOEL) and the ‘No Observed Adverse Effect Level’ (NOAEL) for reproductive and developmental toxicity was considered to be 150 mg/kg bw/day based on reduced offspring body weight gain and litter weights from Day 4 post partum at 450 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd075863-a60b-4c43-9955-3be94b5b144e/documents/9e31c135-ec12-477f-ab92-904e290c60a9_46fea9ea-838e-4401-bee1-fd5f543f5251.html,,,,,, "4-(1,1-dimethylethyl)cyclohexyl methacrylate",46729-07-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd075863-a60b-4c43-9955-3be94b5b144e/documents/9e31c135-ec12-477f-ab92-904e290c60a9_46fea9ea-838e-4401-bee1-fd5f543f5251.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "4-(1,1-dimethylethyl)cyclohexyl methacrylate",46729-07-1," Acute oral toxicity for 4 -tert-butylcyclohexyl methacrylate LD50 is considered to be in the range of 2000 -2400 mg/kg bw. Acute dermal toxicity for 4-tert-butylcyclohexyl methacrylate LD50 is assigned to be > 2000 mg/kg bw (based on cyclohexyl methacrylate, 101 -43 -9 (read across substance)). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd075863-a60b-4c43-9955-3be94b5b144e/documents/00846096-5b25-4f94-b5f9-5aa4f86ab974_46fea9ea-838e-4401-bee1-fd5f543f5251.html,,,,,, "4-(1,1-dimethylethyl)cyclohexyl methacrylate",46729-07-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd075863-a60b-4c43-9955-3be94b5b144e/documents/00846096-5b25-4f94-b5f9-5aa4f86ab974_46fea9ea-838e-4401-bee1-fd5f543f5251.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, "4-(1,1-dimethylethyl)cyclohexyl methacrylate",46729-07-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd075863-a60b-4c43-9955-3be94b5b144e/documents/00846096-5b25-4f94-b5f9-5aa4f86ab974_46fea9ea-838e-4401-bee1-fd5f543f5251.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one; camphorsulphonic acid",909419-73-4," In chronic studies (rat and dog, 6-mo and 1-yr) sedation was the primary drug-related clinical sign and was observed at all doses, with severity being dose related. [FDA]   As stated in CLP Guidance, where the same target organ toxicity of similar severity is observed after single and repeated exposure to a similar dose, it may be concluded that the toxicity is essentially an acute (i.e. single exposure) effect with no accumulation or exacerbation of the toxicity with repeated exposure. In such a case classification with STOT-SE only would be appropriate.   Since sedation and other CNS effects (reversible effects) has been observed both in acute and chronic, at all dose levels tested and these types of effects has been considered for the classification as STOT RE is not relevant.   Other types of adverse effects reported are less relevant and are inconclusive for the classification of the substance. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dfe74b15-0cb9-4303-bfae-6c4c6a24f023/documents/e1702502-995c-4ec3-9d0f-ea4531c58a91_98523aeb-c743-414a-89b1-c65625f5db86.html,,,,,, "5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one; camphorsulphonic acid",909419-73-4," The acute toxicity of the substance was tested in albino mice and Sprague-Dawley rats. The substance was administered to mice (strain nor specified) at doses of 500 and 2000 mg/kg p.o. (3/sex/groups) and 300, 500, and 1000 mg/kg i.p. (3M only). Rats received doses of 500 and 2000 mg/kg p.o. (3/sex) and 500 and 2000 mg/kg i.p. (3M only). Drug-related deaths occurred only in male mice at 1000 mg/kg i. p. Sedation was the primary clinical sign with both routes. CNS signs tended to have a more rapid onset and prolonged duration with i. p. dosing. No target organ for toxicity was identified. LD50's were calculated to be >2000 mg/kg p.o. in both mice and rats and >2000 mg/kg i.p. in rats, and 500-1000 mg/kg i.p. in mice. This study was not definitive due to the lack of a complete battery of measurements, of control groups, and the small n/group.   The available date are conclusive but not sufficient for the classification of the substance for acute oral toxicity. To assess dermal toxicity, ziprasidone was applied to intact skin at a single dose of 2000 mg for 24 hrs. Animals (n= 5) were examined 2 days after drug application. In the dermal study, no drug-related mortality or clinical signs or changes in body wt or food consumption were observed, nor were any signs if dermal irritation detected. The available date are conclusive but not sufficient for the classification of the substance for acute dermal toxicity ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfe74b15-0cb9-4303-bfae-6c4c6a24f023/documents/743a3f30-9617-4b5b-b189-025abd44e075_98523aeb-c743-414a-89b1-c65625f5db86.html,,,,,, "5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one; camphorsulphonic acid",909419-73-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfe74b15-0cb9-4303-bfae-6c4c6a24f023/documents/743a3f30-9617-4b5b-b189-025abd44e075_98523aeb-c743-414a-89b1-c65625f5db86.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "5-[2-[4-(1,2-benzothiazol-3-yl)piperazin-1-yl]ethyl]-6-chloro-1,3-dihydroindol-2-one; camphorsulphonic acid",909419-73-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfe74b15-0cb9-4303-bfae-6c4c6a24f023/documents/743a3f30-9617-4b5b-b189-025abd44e075_98523aeb-c743-414a-89b1-c65625f5db86.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-(1-methyl-1-phenylethyl)-N-[4-(1-methyl-1-phenylethyl)phenyl]aniline,10081-67-1,Repeated Dose Oral Toxicity: 28 day NOAEL 40 mg/kg bw/day Repeated Dose Oral Toxicity: 90 day NOAEL 100 mg/kg bw/day ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e06156ba-ff4f-493c-b1b6-e923e1b48d72/documents/IUC5-5192af8e-d33a-42b9-b727-0d70866e639a_2c154d7d-c95d-42bc-af18-769e0681306a.html,,,,,, 4-(1-methyl-1-phenylethyl)-N-[4-(1-methyl-1-phenylethyl)phenyl]aniline,10081-67-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e06156ba-ff4f-493c-b1b6-e923e1b48d72/documents/IUC5-5192af8e-d33a-42b9-b727-0d70866e639a_2c154d7d-c95d-42bc-af18-769e0681306a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 4-(1-methyl-1-phenylethyl)-N-[4-(1-methyl-1-phenylethyl)phenyl]aniline,10081-67-1,Acute oral LD50 >2000 mg/kg.Acute dermal LD50 >2000 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e06156ba-ff4f-493c-b1b6-e923e1b48d72/documents/IUC5-4adf923f-69fd-49c9-b484-ca5cb8d96e13_2c154d7d-c95d-42bc-af18-769e0681306a.html,,,,,, 4-(1-methyl-1-phenylethyl)-N-[4-(1-methyl-1-phenylethyl)phenyl]aniline,10081-67-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e06156ba-ff4f-493c-b1b6-e923e1b48d72/documents/IUC5-4adf923f-69fd-49c9-b484-ca5cb8d96e13_2c154d7d-c95d-42bc-af18-769e0681306a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-(1-methyl-1-phenylethyl)-N-[4-(1-methyl-1-phenylethyl)phenyl]aniline,10081-67-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e06156ba-ff4f-493c-b1b6-e923e1b48d72/documents/IUC5-4adf923f-69fd-49c9-b484-ca5cb8d96e13_2c154d7d-c95d-42bc-af18-769e0681306a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-(2-acryloyloxy-ethoxy) benzophenone,22421-66-5," The acute oral lethality of MTDID 32918 was evaluated in female Wistar rats.  The study was conducted according to OECD 423 in compliance with OECD GLP.  Two groups of rats (3 females/group) received 2000 mg/kg bodyweight MTDID 32918 “neat” as a liquid via oral gavage. Crystallization of MTDID 32918 was observed prior to dosing the second group and the test item was heated up and subsequently cooled down to obtain a liquid suitable for dosing. Animals were observed daily for clinical signs and mortality.  Body weights were recorded on Day 1 (pre-dose), Day 8 and Day 15.  No mortality occurred. Hunched posture, piloerection, and uncoordinated movements were observed for all animals between Days 1 and 3 only. Ptosis and lethargy were noted in 2/6 animals on Day 1. The mean body weight gain shown by the animals over the study in-life period was considered to be similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination of the animals. The rat oral LD50 is >2000 mg/kg with significant signs of clinical toxicity (i.e., hunched posture and uncoordinated movements). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18466d70-741c-410b-b476-43bd7bb9e279/documents/46ff3ace-7b48-4656-bd9c-5087dd47fe7b_357ffa95-bad4-4adf-8240-4826195d03a1.html,,,,,, "4-(2-chlorophenyl)-N-cyclohexyl-N-ethyl-4,5-dihydro-5-oxo-1H-tetrazole-1-carboxamide",158237-07-1," Chronic Toxicity (OECD 452), oral, dog: NOAEL, non-neoplastic: 20 ppm (equivalent to 0.55 and 0.52 mg/kg bw/day in males and females, respectively) Combined Chronic Toxicity / Carcinogenicity (OECD 453), oral, rat: NOAEL, non-neoplastic: 200 ppm (equivalent to 10.3 and 14.6 mg/kg bw/day in males and females, respectively) Subacute Toxicity (OECD 410), dermal, rat: NOAEL, systemic: 250 mg/kg bw/day NOAEL, local: 1000 mg/kg bw/day (7.5 mg/cm2) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e61281cc-9e10-4218-82a1-20f3c497638c/documents/2b69a441-7445-4887-b50b-f4a07c31236f_931ca1ca-ac0b-435f-8e98-1a97dc727a72.html,,,,,, "4-(2-chlorophenyl)-N-cyclohexyl-N-ethyl-4,5-dihydro-5-oxo-1H-tetrazole-1-carboxamide",158237-07-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e61281cc-9e10-4218-82a1-20f3c497638c/documents/2b69a441-7445-4887-b50b-f4a07c31236f_931ca1ca-ac0b-435f-8e98-1a97dc727a72.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,250 mg/kg bw/day,,rat "4-(2-chlorophenyl)-N-cyclohexyl-N-ethyl-4,5-dihydro-5-oxo-1H-tetrazole-1-carboxamide",158237-07-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e61281cc-9e10-4218-82a1-20f3c497638c/documents/2b69a441-7445-4887-b50b-f4a07c31236f_931ca1ca-ac0b-435f-8e98-1a97dc727a72.html,Chronic toxicity – systemic effects,oral,NOAEL,0.52 mg/kg bw/day,,dog "4-(2-chlorophenyl)-N-cyclohexyl-N-ethyl-4,5-dihydro-5-oxo-1H-tetrazole-1-carboxamide",158237-07-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e61281cc-9e10-4218-82a1-20f3c497638c/documents/2b69a441-7445-4887-b50b-f4a07c31236f_931ca1ca-ac0b-435f-8e98-1a97dc727a72.html,Repeated dose toxicity – local effects,dermal,NOAEL,7.5 mg/cm2,no adverse effect observed,rat "4-(2-chlorophenyl)-N-cyclohexyl-N-ethyl-4,5-dihydro-5-oxo-1H-tetrazole-1-carboxamide",158237-07-1," Acute oral toxicity (OECD 401, GLP), rat: LD50> 5000 mg/kg bw Acute oral toxicity (OECD 401, GLP), mice: LD50> 5000 mg/kg bw Acute inhaltion toxicity (OECD 403, GLP), rat: LC50> 5085 mg/m³ Acute dermal toxicity (OECD 402, GLP), rat: LD50> 5000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e61281cc-9e10-4218-82a1-20f3c497638c/documents/42461185-ae14-4f73-b7b3-ad9cf90401e9_931ca1ca-ac0b-435f-8e98-1a97dc727a72.html,,,,,, 4-(2-hydroxyethyl)-1-piperazinepropanesulphonic acid,16052-06-5,"In an acute oral toxicity study with rats the LD50 value of the read-across substance exceeded 2000 mg/kg (reference 7.2.1-1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The guideline study using the read-across substance is of high quality and reliable without restrictions. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5122de54-2d5b-478d-a1f9-19104ff5057f/documents/9322c827-2edd-4618-915d-f6c773129111_c1ca6eb4-374d-4d4a-9a02-4f0c9d0fc9d4.html,,,,,, 4-(2-hydroxyethyl)-1-piperazinepropanesulphonic acid,16052-06-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5122de54-2d5b-478d-a1f9-19104ff5057f/documents/9322c827-2edd-4618-915d-f6c773129111_c1ca6eb4-374d-4d4a-9a02-4f0c9d0fc9d4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-(2-methylpropyl)benzyl propyl ether,1631962-93-0,Acute oral toxicity: OECD TG 420: LD50 >2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4746d3b-a44b-4d80-ae95-b9644b178af5/documents/8d58013d-753c-4c2d-92af-4a55da0e8800_59032657-ecf5-492d-8b43-05d4b814fa77.html,,,,,, 4-(2-methylpropyl)benzyl propyl ether,1631962-93-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4746d3b-a44b-4d80-ae95-b9644b178af5/documents/8d58013d-753c-4c2d-92af-4a55da0e8800_59032657-ecf5-492d-8b43-05d4b814fa77.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-(3-Butenyl)-4''-ethyl-2'-fluor-1,1':4',1''-terphenyl",825633-86-1," OECD 423 (RL1, rat): LD50 > 2000 mg/kg bw  ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4a7ca0d-88fe-4259-aeb5-8100937a7e41/documents/b61cb49f-a0f5-44ee-8b32-20a7ffee689c_84e73b80-e9e9-4707-a7a8-896f77e0bd0b.html,,,,,, "4-(3-Butenyl)-4''-ethyl-2'-fluor-1,1':4',1''-terphenyl",825633-86-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4a7ca0d-88fe-4259-aeb5-8100937a7e41/documents/b61cb49f-a0f5-44ee-8b32-20a7ffee689c_84e73b80-e9e9-4707-a7a8-896f77e0bd0b.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 4-(3-methylbut-2-enyl)phenol,1200-09-5,"The key oral LD50 value (>300 mg/kg and <2000 mg/kg) is derived from a gavage study in Sprague-Dawley rats according to OECD test guideline 420. At 300 mg/kg, no abnormalities in gross pathology, nor any clinical symptoms were detected. Gross pathology at 2000 mg/kg showed lungs abnormally red, dark liver, dark kidneys, haemorrhagic and ulcerated gastric mucosa and a haemorrhagic non-glandular epithelium of the stomach.Clinical signs of toxicity showed hunched posture, lethargy, ataxia, decreased respiratory rate, loss of righting reflex, laboured respiration, ptosis, hypothermia, urine stained red and finally killed in extremis at 2000 mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/214e4634-f4d5-4c82-8213-6b79b83cb413/documents/IUC5-6b663247-31e2-4c0c-ba33-e10f00536e38_3a7cc5d6-3a8e-4ff4-a226-2a6b23755866.html,,,,,, 4-(3-triethoxysilylpropoxy)-2-hydroxybenzophenone,79876-59-8,"A reliable sub-acute study is available with SHBP.  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A reliable study is available (Klimisch 1 study). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e6793e2-e5c7-49be-9439-0a19e87a90ba/documents/d97101ca-89bc-4e80-9285-439be0bc73cd_9a03f26d-19d8-4975-ab99-2d6b048c01e1.html,,,,,, 4-(3-triethoxysilylpropoxy)-2-hydroxybenzophenone,79876-59-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e6793e2-e5c7-49be-9439-0a19e87a90ba/documents/d97101ca-89bc-4e80-9285-439be0bc73cd_9a03f26d-19d8-4975-ab99-2d6b048c01e1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-(3-triethoxysilylpropoxy)-2-hydroxybenzophenone,79876-59-8,"An acute oral and an acute dermal toxicity study are available, both performed according to OECD/EC guidelines and under GLP principles. The results indicate that SHBP is not accutely toxic. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): A reliable study is available (Klimisch 1). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): A reliable study is available (Klimisch 1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e6793e2-e5c7-49be-9439-0a19e87a90ba/documents/16fa89e1-0c2e-41e5-b87b-dee07b647913_9a03f26d-19d8-4975-ab99-2d6b048c01e1.html,,,,,, 4-(3-triethoxysilylpropoxy)-2-hydroxybenzophenone,79876-59-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e6793e2-e5c7-49be-9439-0a19e87a90ba/documents/16fa89e1-0c2e-41e5-b87b-dee07b647913_9a03f26d-19d8-4975-ab99-2d6b048c01e1.html,,oral,LD0,"2,000 mg/kg bw",no adverse effect observed, 4-(3-triethoxysilylpropoxy)-2-hydroxybenzophenone,79876-59-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e6793e2-e5c7-49be-9439-0a19e87a90ba/documents/16fa89e1-0c2e-41e5-b87b-dee07b647913_9a03f26d-19d8-4975-ab99-2d6b048c01e1.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, 4-(6-methylbenzothiazol-2-yl)aniline,92-36-4,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0347dbe-8f68-452e-8bfb-7556135549a7/documents/IUC5-647e6d7c-12e6-4dbe-8d2b-b2f143447a68_41733052-cc5e-49cd-9b24-589b802f7cfc.html,,oral,LD50,"6,350 mg/kg bw",adverse effect observed, 4-(6-methylbenzothiazol-2-yl)aniline,92-36-4,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0347dbe-8f68-452e-8bfb-7556135549a7/documents/IUC5-647e6d7c-12e6-4dbe-8d2b-b2f143447a68_41733052-cc5e-49cd-9b24-589b802f7cfc.html,,dermal,LD50,"17,000 mg/kg bw",no adverse effect observed, 4-(6-methylbenzothiazol-2-yl)aniline,92-36-4,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0347dbe-8f68-452e-8bfb-7556135549a7/documents/IUC5-647e6d7c-12e6-4dbe-8d2b-b2f143447a68_41733052-cc5e-49cd-9b24-589b802f7cfc.html,,inhalation,discriminating conc.,"3,000 mg/m3",adverse effect observed, 4-(cyclohexylamino)butane-1-sulfonic acid,161308-34-5, A combined 28-day repeated dose toxicity study with reproduction/developmental toxicity screening test was performed according to OECD TG 422 with the substance. Based on the absence of adverse effects up to and including the highest dose level the NOAEL was determined to be at least 1000 mg/kg bw/day. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6215f690-228c-497c-91d6-1840a3df9fef/documents/5bf1e3fa-7819-48f5-91f8-052303950493_5808d74c-630c-4f94-9551-7d4f49a6e104.html,,,,,, 4-(cyclohexylamino)butane-1-sulfonic acid,161308-34-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6215f690-228c-497c-91d6-1840a3df9fef/documents/5bf1e3fa-7819-48f5-91f8-052303950493_5808d74c-630c-4f94-9551-7d4f49a6e104.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-(cyclohexylamino)butane-1-sulfonic acid,161308-34-5,"In an acute oral toxicity study with the substance performed in accordance with OECD 423, an LD50 of >2000 mg/kg bw was determined. As no mortality occurred, the LD50 cut-off value was considered to be 5000 mg/kg body weight according to the OECD 423 test guideline. Based on the expert statement and as the criteria in Column 2 of Section 8.5.2 of REACH are not fulfilled testing by the inhalation route is not performed. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6215f690-228c-497c-91d6-1840a3df9fef/documents/1ee1aeb0-6275-42fa-abe1-82a6dfbb53b5_5808d74c-630c-4f94-9551-7d4f49a6e104.html,,,,,, 4-(cyclohexylamino)butane-1-sulfonic acid,161308-34-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6215f690-228c-497c-91d6-1840a3df9fef/documents/1ee1aeb0-6275-42fa-abe1-82a6dfbb53b5_5808d74c-630c-4f94-9551-7d4f49a6e104.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 4-(dodecylthio)-4-methylpentan-2-one,855737-35-8," The acute oral toxicity of Scentaurus Juicy (GR-87 -7596) has been tested under the OECD guideline No. 423. It has been concluded that the median lethal dose of Scentaurus Juicy after single oral administration to female rats is: LD50 (female rat): greater than 2000 mg/kg body weight According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1bb9cf5-1156-40e1-bca0-9dca2e639b96/documents/ed01f58f-a0bc-4c69-af49-fb76ff7b11f7_9e3a66d8-d308-431c-b2b4-3bea4e0bbb04.html,,,,,, 4-(dodecylthio)-4-methylpentan-2-one,855737-35-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1bb9cf5-1156-40e1-bca0-9dca2e639b96/documents/ed01f58f-a0bc-4c69-af49-fb76ff7b11f7_9e3a66d8-d308-431c-b2b4-3bea4e0bbb04.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 4-(hydroxymethyl)-4-methyl-1-phenylpyrazolidin-3-one,13047-13-7," Five rats per sex received a single dose of 1100, 1500 or 2000 mg/kg bw by gavage. During the 14 day observation period 4, 6 and 9 animals died at 1100, 1500 and 2000 mg/kg respectively. These animals showed decreased body weight, apathy and letargy and effects on the antrum. Other animals survived and showed no clear treatment related effects (NOTOX 1985). Based on these findings it is concluded that the LD50 is 1300 mg/kg bw (males and females combined). In a limited report the LD50 is 556 mg/kg bw (Kodak 1992) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f43a8493-d7ec-4358-8225-aef95540b60f/documents/3849b21c-649c-4610-8ad5-00e778e7d1f4_892abf6d-1675-42b9-ae85-9e11fb78522a.html,,,,,, 4-(hydroxymethyl)-4-methyl-1-phenylpyrazolidin-3-one,13047-13-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f43a8493-d7ec-4358-8225-aef95540b60f/documents/3849b21c-649c-4610-8ad5-00e778e7d1f4_892abf6d-1675-42b9-ae85-9e11fb78522a.html,,oral,LD50,"1,300 mg/kg bw",adverse effect observed, 4-(octadecylamino)-4-oxoisocrotonic acid,3077-27-8," Oral (OECD 422, Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, rat): NOAEL (females) = 100 mg/kg bw/day; NOAEL (males) = 1000 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8240764f-9ce6-4dbe-81b8-7c53bcf0a7b0/documents/2aa46090-aac1-4cb2-bfd6-a4bf46990dff_9df66d35-29fa-48de-9371-2a866072b1d6.html,,,,,, 4-(octadecylamino)-4-oxoisocrotonic acid,3077-27-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8240764f-9ce6-4dbe-81b8-7c53bcf0a7b0/documents/2aa46090-aac1-4cb2-bfd6-a4bf46990dff_9df66d35-29fa-48de-9371-2a866072b1d6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 4-(octadecylamino)-4-oxoisocrotonic acid,3077-27-8," Oral (OECD 423), rat, LD50 > 2000 mg/kg bw Dermal (OECD 402), rat, LD50 > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8240764f-9ce6-4dbe-81b8-7c53bcf0a7b0/documents/294685ba-04a3-4dcc-8559-919f69ec67ed_9df66d35-29fa-48de-9371-2a866072b1d6.html,,,,,, 4-(trans-4-propylcyclohexyl)acetophenone,78531-61-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP and guideline compliant studies assessed in a WoE approach ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/20a3861b-9fac-475c-98bf-4049027eee36/documents/6770deb1-4de8-422c-9a18-fbf7c6f189a6_34d8d46b-556a-46a3-9a38-3c18166d79ec.html,,,,,, 4-(trans-4-propylcyclohexyl)acetophenone,78531-61-0,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/20a3861b-9fac-475c-98bf-4049027eee36/documents/6770deb1-4de8-422c-9a18-fbf7c6f189a6_34d8d46b-556a-46a3-9a38-3c18166d79ec.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 4-(trans-4-propylcyclohexyl)acetophenone,78531-61-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): OECD TG 401, GLP Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): OECD TG 402, GLP ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20a3861b-9fac-475c-98bf-4049027eee36/documents/97d27cd1-41ad-409a-8886-fdc04b2c6283_34d8d46b-556a-46a3-9a38-3c18166d79ec.html,,,,,, 4-(trans-4-propylcyclohexyl)acetophenone,78531-61-0,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20a3861b-9fac-475c-98bf-4049027eee36/documents/97d27cd1-41ad-409a-8886-fdc04b2c6283_34d8d46b-556a-46a3-9a38-3c18166d79ec.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 4-(trans-4-propylcyclohexyl)acetophenone,78531-61-0,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20a3861b-9fac-475c-98bf-4049027eee36/documents/97d27cd1-41ad-409a-8886-fdc04b2c6283_34d8d46b-556a-46a3-9a38-3c18166d79ec.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 4-(vinyloxy)butan-1-ol,17832-28-9,"In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422) in Wistar rats the NOAEL for general, systemic toxicity of the test substance was 150 mg/kg body weight/day for the F0 parental animals based on adverse clinical findings (males + females) and decreased body weight gain (males) at 450 mg/kg body weight/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d59cc6f-7061-45a8-a17d-3fbbb9e22639/documents/IUC5-cea195bb-539b-40ff-a4ad-928c161473c8_c5cdb89f-f18c-4466-82d0-d3b351ba5add.html,,,,,, 4-(vinyloxy)butan-1-ol,17832-28-9,"The combined oral LD50 in male and female rats was 1740 mg/kg bw, in males 1780 mg/kg bw and for females 1540 mg/kg bw.Inhalation of saturated vapour for 7 hrs in rats resulted in slight clinical signs but in no mortality in the inhalation hazard test.In a limit test on acute dermal toxicity in rats no clinical signs were reported at a dose of 2000 mg/kg bw; LD50 is >2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d59cc6f-7061-45a8-a17d-3fbbb9e22639/documents/IUC5-355b387f-67f7-44ad-96f9-09c37f03648a_c5cdb89f-f18c-4466-82d0-d3b351ba5add.html,,,,,, 4-(vinyloxy)butan-1-ol,17832-28-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d59cc6f-7061-45a8-a17d-3fbbb9e22639/documents/IUC5-355b387f-67f7-44ad-96f9-09c37f03648a_c5cdb89f-f18c-4466-82d0-d3b351ba5add.html,,oral,LD50,"1,740 mg/kg bw",, "4-(α,α-dimethylbenzyl)phenol",599-64-4,In a repeated dose oral study performed per OECD Test Guideline 422 the NOAEL in the rat was 50 mg/kg. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/367bc5a0-6d36-45be-93d2-a24568ef6187/documents/bc48a067-4523-43d4-acaa-97110fa1f115_81ceda0f-3e50-4e50-9394-7f3c8a175663.html,,,,,, "4-(α,α-dimethylbenzyl)phenol",599-64-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/367bc5a0-6d36-45be-93d2-a24568ef6187/documents/bc48a067-4523-43d4-acaa-97110fa1f115_81ceda0f-3e50-4e50-9394-7f3c8a175663.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "4-(α,α-dimethylbenzyl)phenol",599-64-4, In an acute oral study performed per EPA TSCA 40 CFR 798.1175 the LD50 in the rat was 1.77 g/kg. An additional study determined that the combined male and female LD50 was 2.82 g/kg. In an acute dermal study performed per OECD Test Guideline 402 and OPPTS 870.1200 the LD50 in the rabbit was >2000 mg/kg. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/367bc5a0-6d36-45be-93d2-a24568ef6187/documents/88dcd3b2-0e41-4968-9afb-5ef73268586c_81ceda0f-3e50-4e50-9394-7f3c8a175663.html,,,,,, "4-(α,α-dimethylbenzyl)phenol",599-64-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/367bc5a0-6d36-45be-93d2-a24568ef6187/documents/88dcd3b2-0e41-4968-9afb-5ef73268586c_81ceda0f-3e50-4e50-9394-7f3c8a175663.html,,oral,LD50,"1,770 mg/kg bw",adverse effect observed, "4-(α,α-dimethylbenzyl)phenol",599-64-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/367bc5a0-6d36-45be-93d2-a24568ef6187/documents/88dcd3b2-0e41-4968-9afb-5ef73268586c_81ceda0f-3e50-4e50-9394-7f3c8a175663.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,10-dibromodibenzo[def,mno]chrysene-6,12-dione",4378-61-4,"Repeated oral toxicity:An OECD test guideline (OECD 422) and GLP-compliant Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test was performed with the test item (Pigment Red 168). Groups of 11 male and 11 female Wistar rats received doses of 0, 100, 300 and 1000 mg/kg bw by daily gavage for 28 days (males) and 49 days (females). No toxicologically significant changes were noted in any of the parameters investigated in this study (such as clinical signs, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). A No Observed Adverse Effect Level (NOAEL) for the test item of 1000 mg/kg/day was established.Repeated dermal toxicity:The dermal route was waived. The substance is considered not to exert adverse effects.Repeated inhalation toxicity:The inhalation route was waived. The substance is considered not to exert adverse effects. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff63dbff-97af-4685-8694-9773a8d7e52a/documents/22ce29c0-6d1b-4227-b93a-9b3931b15efe_d758d7be-9dc8-4ed7-bec4-ede3a57a48cb.html,,,,,, "4,10-dibromodibenzo[def,mno]chrysene-6,12-dione",4378-61-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff63dbff-97af-4685-8694-9773a8d7e52a/documents/22ce29c0-6d1b-4227-b93a-9b3931b15efe_d758d7be-9dc8-4ed7-bec4-ede3a57a48cb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, "4,10-dibromodibenzo[def,mno]chrysene-6,12-dione",4378-61-4," acute oral toxicity: The test item (C.I. Pigment Red 168) did not cause any mortality or clinical signs or necropsy findings after single oral gavage administration to male and female rats at 5000 mg/kg bw in a valid pre-guideline study. The LD50 (male/female rat) was greater than 5000 mg/kg body weight. In a similarly conducted study the test item did not cause any mortality, clinical signs or necropsy findings after single oral gavage administration to female rats at 15000 mg/kg bw. Acute dermal toxicity: Pigment Red 168 did not cause any mortality or clinical signs or necropsy findings after single dermal administration to male and female rats at 2000 mg/kg bw in a OECD guideline and GLP compliant study. Acute inhalation toxicity: Study was waived and classification for this endpoint is considered unwarranted. When aerosolized in respirable form, the substance is considered likely to behave like an inert dust. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff63dbff-97af-4685-8694-9773a8d7e52a/documents/18cc3a8e-20a4-4259-a6a8-129a2419ba00_d758d7be-9dc8-4ed7-bec4-ede3a57a48cb.html,,,,,, "4,10-dibromodibenzo[def,mno]chrysene-6,12-dione",4378-61-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff63dbff-97af-4685-8694-9773a8d7e52a/documents/18cc3a8e-20a4-4259-a6a8-129a2419ba00_d758d7be-9dc8-4ed7-bec4-ede3a57a48cb.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "4,10-dibromodibenzo[def,mno]chrysene-6,12-dione",4378-61-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff63dbff-97af-4685-8694-9773a8d7e52a/documents/18cc3a8e-20a4-4259-a6a8-129a2419ba00_d758d7be-9dc8-4ed7-bec4-ede3a57a48cb.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4,11-diamino-2-(3-methoxypropyl)-1H-naphth[2,3-f]isoindol-1,3,5,10(2H)-tetrone",12217-80-0,NOAEL (No Observed Adverse Effect Level) for males and females was established at 150 mg/kg bw/day. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5fa5b9dc-3cbb-4dd9-a0a0-0b9cdff108d8/documents/IUC5-682f6b17-6998-40d0-9537-400cd6eb486d_0a850cd2-d5db-4557-9dec-8b9296a5aaba.html,,,,,, "4,11-diamino-2-(3-methoxypropyl)-1H-naphth[2,3-f]isoindol-1,3,5,10(2H)-tetrone",12217-80-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5fa5b9dc-3cbb-4dd9-a0a0-0b9cdff108d8/documents/IUC5-682f6b17-6998-40d0-9537-400cd6eb486d_0a850cd2-d5db-4557-9dec-8b9296a5aaba.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "4,11-diamino-2-(3-methoxypropyl)-1H-naphth[2,3-f]isoindol-1,3,5,10(2H)-tetrone",12217-80-0,FAT 36152/M is considered to have low toxicity by oral route. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fa5b9dc-3cbb-4dd9-a0a0-0b9cdff108d8/documents/IUC5-04d0a914-1021-4825-a488-9c50b9898d34_0a850cd2-d5db-4557-9dec-8b9296a5aaba.html,,,,,, "4,11-diamino-2-(3-methoxypropyl)-1H-naphth[2,3-f]isoindol-1,3,5,10(2H)-tetrone",12217-80-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fa5b9dc-3cbb-4dd9-a0a0-0b9cdff108d8/documents/IUC5-04d0a914-1021-4825-a488-9c50b9898d34_0a850cd2-d5db-4557-9dec-8b9296a5aaba.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,11-diamino-2-[3-(2-methoxyethoxy)propyl]-1H-naphth[2,3-f]isoindole-1,3,5,10(2H)-tetrone",65059-45-2,Target chemical is considered to have low toxicity by oral route. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65b4e4f5-d7fa-469a-8312-a0dddf9a4896/documents/IUC5-b8b97ad9-748f-4c91-85f8-52ef671e072a_5b65478e-5191-40a3-b284-13b3598cf679.html,,,,,, "4,11-diamino-2-[3-(2-methoxyethoxy)propyl]-1H-naphth[2,3-f]isoindole-1,3,5,10(2H)-tetrone",65059-45-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65b4e4f5-d7fa-469a-8312-a0dddf9a4896/documents/IUC5-b8b97ad9-748f-4c91-85f8-52ef671e072a_5b65478e-5191-40a3-b284-13b3598cf679.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,11-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione",3089-16-5,"Oral: Read-across, NOAEL 1000 mg/kg bw/d Inhalation: NOAEC(systemic) > 60 mg/m³, LOAEC(local) = 5 mg/m³ Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): similar to OECD TG 412, GLP, K1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): similar to OECD TG 412, GLP, K1 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54925aea-8b47-47c1-a216-07c20f139e7d/documents/14dbce76-1959-4233-9d72-fe1799aab8b0_be248347-41bf-40e5-9da5-fca3a99b8b17.html,,,,,, "4,11-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione",3089-16-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54925aea-8b47-47c1-a216-07c20f139e7d/documents/14dbce76-1959-4233-9d72-fe1799aab8b0_be248347-41bf-40e5-9da5-fca3a99b8b17.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4,11-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione",3089-16-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54925aea-8b47-47c1-a216-07c20f139e7d/documents/14dbce76-1959-4233-9d72-fe1799aab8b0_be248347-41bf-40e5-9da5-fca3a99b8b17.html,Repeated dose toxicity – local effects,inhalation,LOAEC,5 mg/m3,adverse effect observed,rat "4,11-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione",3089-16-5,"Oral: Read-across, LD50 > 2000 mg/kg bw Inhalation: Read-across, LC50 > 3.1 mg/L Dermal: no data availabe ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54925aea-8b47-47c1-a216-07c20f139e7d/documents/365af85a-70e6-4130-bada-dba9ed4e8a21_be248347-41bf-40e5-9da5-fca3a99b8b17.html,,,,,, "4,11-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione",3089-16-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54925aea-8b47-47c1-a216-07c20f139e7d/documents/365af85a-70e6-4130-bada-dba9ed4e8a21_be248347-41bf-40e5-9da5-fca3a99b8b17.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4,11-dichloro-5,12-dihydroquino[2,3-b]acridine-7,14-dione",3089-16-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54925aea-8b47-47c1-a216-07c20f139e7d/documents/365af85a-70e6-4130-bada-dba9ed4e8a21_be248347-41bf-40e5-9da5-fca3a99b8b17.html,,inhalation,discriminating conc.,3.1 mg/L,no adverse effect observed, "3,10-bis[(2-aminopropyl)amino]-6,13-dichloro[1,4]benzoxazino[2,3-b]phenoxazine-4,11-disulfonic acid",133047-57-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2df33183-1369-4e42-8897-7d93113f3214/documents/IUC5-3f494013-6ce6-4f4e-82d9-fc5f292eb541_53a6c93d-9ace-4afd-a4ab-887c36cb3074.html,,oral,LD50,"2,000 mg/kg bw",, "4,4'-((4-(phenylamino)naphthalen-1-yl)methylene)bis(N,N-dimethylbenzenamine)",82941-24-0, Acute oral toxicity in rats: LD50 between 300 and 2000 mg/kg. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6359d8b-aec6-44f6-ad7f-c93811c93905/documents/17650835-1ca5-4eae-bfb5-ed7418dba833_68c2bf52-1dcd-44ad-83f2-7d3e69fa69c3.html,,,,,, "4,4'-((4-(phenylamino)naphthalen-1-yl)methylene)bis(N,N-dimethylbenzenamine)",82941-24-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6359d8b-aec6-44f6-ad7f-c93811c93905/documents/17650835-1ca5-4eae-bfb5-ed7418dba833_68c2bf52-1dcd-44ad-83f2-7d3e69fa69c3.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, 4-[2-ethyl-1-(4-hydroxyphenyl)hexyl]phenol,74462-02-5,"LD50 (oral, rat): 300 - 2000 mg/kg bw according to acute toxic class method ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e938b13-f3ba-4dda-b552-06e46022ca0e/documents/IUC5-a420a227-b17f-4d31-8504-917bcd2d0d53_a5939324-3029-432a-8eba-60d4b672c391.html,,,,,, 4-[2-ethyl-1-(4-hydroxyphenyl)hexyl]phenol,74462-02-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e938b13-f3ba-4dda-b552-06e46022ca0e/documents/IUC5-a420a227-b17f-4d31-8504-917bcd2d0d53_a5939324-3029-432a-8eba-60d4b672c391.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "4,4'-(4-methylpentane-2,2-diyl)bis((heptyloxy)benzene)",1951440-04-2," In an acute toxicity study the substance was administered to nine female Wistar Han rats by oral gavage with three animals receiving 300 mg/kg bw followed by six animals receiving a dose of 2000 mg/kg bw (single administration). At 300 mg/kg bw, hunched posture and piloerection were noted for all animals between days 1 and 6. At 2000 mg/kg bw, hunched posture and piloerection were noted for all animals on Days 1 and/or 2. There were no mortalities or other signs of clinical toxicity, mean body weight gain was comparable with the control animals and no abnormalities found at macroscopic post-mortem examination.The oral LD50 is considered to be >2000 mg/kg bw. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e58ece89-6be2-4d7e-9238-02eb1b5b7126/documents/d25eb6b2-ccf8-4619-a215-6ff14dbf69a7_9807288a-87de-478e-a145-bab637c8c26e.html,,,,,, "4,4'-(4-methylpentane-2,2-diyl)bis((heptyloxy)benzene)",1951440-04-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e58ece89-6be2-4d7e-9238-02eb1b5b7126/documents/d25eb6b2-ccf8-4619-a215-6ff14dbf69a7_9807288a-87de-478e-a145-bab637c8c26e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-(9H-fluoren-9-ylidene)bis(2-chloroaniline)",107934-68-9,"Repeated dose toxicity (according to OECD 408, GLP): NOAEL ≥ 1000 mg/kg bw/d Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.6, of Regulation (EC) No 1907/2006. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a92bcb1b-e70e-4bbc-9f89-345c63b909eb/documents/IUC5-0e68ae9b-8495-4f00-8d85-babe0ce06cdd_8e05b6a9-ab67-49c6-b70f-07a4fd4ceefe.html,,,,,, "4,4'-(9H-fluoren-9-ylidene)bis(2-chloroaniline)",107934-68-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a92bcb1b-e70e-4bbc-9f89-345c63b909eb/documents/IUC5-0e68ae9b-8495-4f00-8d85-babe0ce06cdd_8e05b6a9-ab67-49c6-b70f-07a4fd4ceefe.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4,4'-(9H-fluoren-9-ylidene)bis(2-chloroaniline)",107934-68-9," Oral (OECD 401), rat: LD50 >5000 mg/kg bw Inhalation (OECD 436), rat: LC50 >3 mg/L air (maximum attainable concentration)Dermal (OECD 402), rat: LD50 >2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a92bcb1b-e70e-4bbc-9f89-345c63b909eb/documents/IUC5-29afe345-d61d-4f2f-9e57-4b2e7a9a27b4_8e05b6a9-ab67-49c6-b70f-07a4fd4ceefe.html,,,,,, "4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane",56706-10-6," In the key 28-day repeated dose oral gavage study conducted according to OECD Test Guideline 407 and in compliance with GLP, the NOAEL for 4,4,13,13 -tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane (""S2""; CAS No.: 56706-10-6; EC No.: 260-350-7) was 200 mg/kg bw/day in rats (Hita Laboratory, 2000a).   The repeated dose toxicity endpoint will be updated upon completion of the planned 90-day OECD Test Guideline study with the read-across substance bis[3-(triethoxysilyl)propyl]polysulfides (draft decision received; DEV-01-2119463597-25-0000-TPE-3), especially in respect of the renal findings (tubular basophilia) identified as in the OECD Test Guideline 407 studies (S2: Hita Laboratory, 2000a; bis[3-(triethoxysilyl)propyl]polysulfides: Hita Laboratory, 2000b) and which was identified as adverse in the OECD Test Guideline 443 (EOGRTS) study with this substance (draft report, Charles River Laboratories, 2022; see Section 5.9.3 (Summary and discussion of reproductive toxicity, Effects on fertility). No repeated dose data are available for the dermal and inhalation routes. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1eb5dacf-550e-45e7-94a1-611364ad16d4/documents/c36a94fc-7004-4015-be9c-5901108608e2_a3ae8f30-9c43-4698-9f05-0d58328b49ce.html,,,,,, "4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane",56706-10-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1eb5dacf-550e-45e7-94a1-611364ad16d4/documents/c36a94fc-7004-4015-be9c-5901108608e2_a3ae8f30-9c43-4698-9f05-0d58328b49ce.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane",56706-10-6," The key study for acute oral toxicity reports an LD50 value of greater than 2150 mg/kg bw for 4,4,13,13 -tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane (""S2""; CAS No. 56706-10-6, EC No. 260-350-7) conducted according to OECD Test Guideline 401 and in compliance with GLP (ASTA Medica AG, 1996).   The key read-across acute inhalation toxicity study with bis[3-(triethoxysilyl)polysulfides (“polysulfides”; CAS No. 211519-85-6, EC No. 915-673-4) was conducted according to OECD Test Guideline 403 but pre-dated GLP. In this study, a polysulfides LC50 of at least 7967 mg/m3 in rats exposed for 4 hours was identified. No deaths were reported and clinical signs were minor and transient (RCC Ltd, 1983).   The key study for acute dermal toxicity was conducted with low purity S2, in which an S2 LD50 value of greater than 2000 mg/kg bw was determined. The study was conducted according to OECD Test Guideline 402 and in compliance with GLP (WIL, 2000). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1eb5dacf-550e-45e7-94a1-611364ad16d4/documents/90b527fb-c072-43b4-bf7b-aaf2f4830748_a3ae8f30-9c43-4698-9f05-0d58328b49ce.html,,,,,, "4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane",56706-10-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1eb5dacf-550e-45e7-94a1-611364ad16d4/documents/90b527fb-c072-43b4-bf7b-aaf2f4830748_a3ae8f30-9c43-4698-9f05-0d58328b49ce.html,,oral,LD50,"> 2,150 mg/kg bw",no adverse effect observed, "4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane",56706-10-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1eb5dacf-550e-45e7-94a1-611364ad16d4/documents/90b527fb-c072-43b4-bf7b-aaf2f4830748_a3ae8f30-9c43-4698-9f05-0d58328b49ce.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4,4,13,13-tetraethoxy-3,14-dioxa-8,9-dithia-4,13-disilahexadecane",56706-10-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1eb5dacf-550e-45e7-94a1-611364ad16d4/documents/90b527fb-c072-43b4-bf7b-aaf2f4830748_a3ae8f30-9c43-4698-9f05-0d58328b49ce.html,,inhalation,LC50,"> 7,967 mg/m3",no adverse effect observed, "4,4',4''-(ethan-1,1,1-triyl)triphenol",27955-94-8, 28-Day gavage study; rat; NOAEL 100 mg/kg; Reliability = 1 ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21a7766f-1e6e-454d-ae18-d0e2423a6d8b/documents/IUC5-3571c2cd-d7b4-43c5-8fb2-b636ba9187ae_ecf45222-db24-4321-be52-82072f903757.html,,,,,, "4,4',4''-(ethan-1,1,1-triyl)triphenol",27955-94-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21a7766f-1e6e-454d-ae18-d0e2423a6d8b/documents/IUC5-3571c2cd-d7b4-43c5-8fb2-b636ba9187ae_ecf45222-db24-4321-be52-82072f903757.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,"1,000 mg/kg bw/day",,rat "4,4',4''-(ethan-1,1,1-triyl)triphenol",27955-94-8, Oral: EU Method B.1; rat LC50 >5000 mg/kg. Reliability = 1 Inhalation: No study available Dermal: EU Method B.3; rat LD50 >2000 mg/kg. Reliability = 1 ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21a7766f-1e6e-454d-ae18-d0e2423a6d8b/documents/IUC5-79411cff-97cc-4382-a103-e036a9f4411e_ecf45222-db24-4321-be52-82072f903757.html,,,,,, "4,4',4''-methylidynetrianiline",548-61-8,LD50 acute oral in the rat is > 2000 mg/kg bw ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aee1bd5f-9744-4092-92b3-42427c81ad9d/documents/IUC5-48baad13-2ac6-478e-a054-81d033b38d28_6f7fd137-1762-473e-a55d-8c730cc1df47.html,,,,,, "4,4',4''-triaminotrityl alcohol",467-62-9," Acute oral toxicity:  LD50 was considered to be 2376 mg/kg bw when male rats were orally exposed with 4,4',4''-Triaminotrityl alcohol. Acute Dermal toxicity:  LD50 was considered to be 2841.1 mg/kg bw, when female New Zealand White rabbits were treated with 4,4',4''-Triaminotrityl alcohol by dermal application. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e04945b5-ea91-47a2-952d-e2c2fb1b7473/documents/c27a8937-44ab-46db-9749-a8327c7b2cb8_cec6644a-5f7f-4dce-bf74-a236d80f095c.html,,,,,, "4,4',4''-triaminotrityl alcohol",467-62-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e04945b5-ea91-47a2-952d-e2c2fb1b7473/documents/c27a8937-44ab-46db-9749-a8327c7b2cb8_cec6644a-5f7f-4dce-bf74-a236d80f095c.html,,oral,LD50,"2,376 mg/kg bw",no adverse effect observed, "4,4',4''-triaminotrityl alcohol",467-62-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e04945b5-ea91-47a2-952d-e2c2fb1b7473/documents/c27a8937-44ab-46db-9749-a8327c7b2cb8_cec6644a-5f7f-4dce-bf74-a236d80f095c.html,,dermal,LD50,"2,841.1 mg/kg bw",no adverse effect observed, "4,4,5,5-Tetramethyl-1,3,2-dioxaborolane",25015-63-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Raw data of acute toxicity study with the read across substance boric acid (CAS 10043-35-3) containing limited information but adequate for the purposes of hazard identification and classification. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b83c2f29-28e0-4067-b1f8-79b14641d02e/documents/IUC5-fa3f00ba-21d6-41c8-bc85-5a35c574f8f1_df9f083b-068c-4488-8f96-1595f35f5328.html,,,,,, "4,4,5,5-Tetramethyl-1,3,2-dioxaborolane",25015-63-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b83c2f29-28e0-4067-b1f8-79b14641d02e/documents/IUC5-fa3f00ba-21d6-41c8-bc85-5a35c574f8f1_df9f083b-068c-4488-8f96-1595f35f5328.html,,oral,LD50,"3,350 mg/kg bw",adverse effect observed, "4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane",16068-37-4,"In the key sub-chronic oral repeated dose toxicity study with 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane (CAS 16068-37-4, EC 240-212-2) in the Wistar Han rat, conducted according to OECD Test Guideline 408 and in compliance with GLP (Charles River Laboratories, 2023a, reliability 1), the No Observed Adverse Effect Level (NOAEL) was determined to be the low dose of 10 mg/kg bw/day, based on adverse test item-related morphologic alterations in the heart and liver from 20 mg/kg bw/day. The study was conducted in compliance with ECHA decision number TPE D 2114575378-34-01/D. Due to mortality / toxicity at the initial high dose of 40 mg/kg bw/day, this dose was lowered to 30 mg/kg bw/day in main animals and 20 mg/kg bw/day in recovery animals from Study Day 25. By Study Day 32, all high dose main / recovery animals were dead (found dead or euthanised early, with one accidental death during Study Day 32 blood collection). In addition, there were two main male deaths at 20 mg/kg bw/day, one found dead on Study Day 55 and the second sacrificed early on Study Day 85. Except for the accidental high dose death, the cause of death was related to the effects on the heart and liver. Based on evaluation of serum thyroid levels and endocrine / reproductive organ terminal examinations in surviving animals, a concern for potential endocrine disruption is not identified.   In the key subacute inhalation study with the registered substance in the Sprague Dawley rat, conducted according to OECD Test Guideline 412 and in compliance with GLP (Dow Corning Corporation, 1998, reliability 1), the local No Observed Adverse Effect Concentration (NOAEC) was <0.186 ppm (measured; approximately 0.003 mg/l). It is considered that there were no adverse test item-related systemic effects (study summary author opinion) up to the highest concentration of 1.4 ppm (measured; approximately 0.020 mg/l). Limited endocrine-related organ weight collection / histopathology was undertaken in this subacute study, with no indication of a concern for potential endocrine disruption. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32162c29-d4df-4bbe-8048-591b89c32b9b/documents/a1ab2932-8b58-4d9d-9b18-e6e82c2c62bc_e91b5ffd-1642-4ef5-935f-9cb43790ffae.html,,,,,, "4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane",16068-37-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32162c29-d4df-4bbe-8048-591b89c32b9b/documents/a1ab2932-8b58-4d9d-9b18-e6e82c2c62bc_e91b5ffd-1642-4ef5-935f-9cb43790ffae.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,>= 20 mg/m3,,rat "4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane",16068-37-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32162c29-d4df-4bbe-8048-591b89c32b9b/documents/a1ab2932-8b58-4d9d-9b18-e6e82c2c62bc_e91b5ffd-1642-4ef5-935f-9cb43790ffae.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane",16068-37-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32162c29-d4df-4bbe-8048-591b89c32b9b/documents/a1ab2932-8b58-4d9d-9b18-e6e82c2c62bc_e91b5ffd-1642-4ef5-935f-9cb43790ffae.html,Repeated dose toxicity – local effects,inhalation,LOAEC,2.7 mg/m3,adverse effect observed,rat "4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane",16068-37-4,"In the key acute oral toxicity study with 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane (CAS 16068-37-4, EC 240-212-2), conducted according to OECD Test Guideline 401 and GLP (WIL Research Associates, 2000, reliability 1), the oral LD50 was 161 mg/kg bw.   In the key acute inhalation toxicity study with registered substance, conducted according to OECD Test Guideline 403 and GLP (Dow Corning Corporation, 1977, reliability 1), the 4-hour LC50 was >26 ppm vapour (> approximately 0.38 mg/l).   In the key acute dermal toxicity study with 4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane, conducted according to OECD Test Guideline 402 and GLP (Pharmakon Europe, 1994, reliability 1), the dermal LD50 was 1972 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32162c29-d4df-4bbe-8048-591b89c32b9b/documents/8fb3bf84-2d9f-473d-92ed-dfe84819f9b5_e91b5ffd-1642-4ef5-935f-9cb43790ffae.html,,,,,, "4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane",16068-37-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32162c29-d4df-4bbe-8048-591b89c32b9b/documents/8fb3bf84-2d9f-473d-92ed-dfe84819f9b5_e91b5ffd-1642-4ef5-935f-9cb43790ffae.html,,oral,LD50,161 mg/kg bw,adverse effect observed, "4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane",16068-37-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32162c29-d4df-4bbe-8048-591b89c32b9b/documents/8fb3bf84-2d9f-473d-92ed-dfe84819f9b5_e91b5ffd-1642-4ef5-935f-9cb43790ffae.html,,dermal,LD50,"1,972 mg/kg bw",adverse effect observed, "4,4,7,7-tetraethoxy-3,8-dioxa-4,7-disiladecane",16068-37-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32162c29-d4df-4bbe-8048-591b89c32b9b/documents/8fb3bf84-2d9f-473d-92ed-dfe84819f9b5_e91b5ffd-1642-4ef5-935f-9cb43790ffae.html,,inhalation,LC50,380 mg/m3,no adverse effect observed, "4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-(p-tolyl)-3H-pyrazol-3-one]",15793-73-4," In the “Combined Repeated Dose Oral Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test”, the no observed adverse effect level (NOAEL) is considered to be 1000 mg/kg body weight/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b00cf308-53d6-4f05-b38a-1cd91e2fc004/documents/6c8d2c86-6b86-4148-954d-4d49535d53ae_9039c9a3-bb63-4ff8-ba48-1896ea84b208.html,,,,,, "4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-(p-tolyl)-3H-pyrazol-3-one]",15793-73-4," Oral: LD50 (Pigment Orange 34, nano form) >15000 mg/kg LD50 (strucrue analogue Pigment Orange 13, nano form) >2100 mg/kg Inhalation: Waiving   Dermal: LD50 (strucrue analogue Pigment Orange 38, nano form) >2000 mg/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b00cf308-53d6-4f05-b38a-1cd91e2fc004/documents/464ec627-8076-4877-b5a1-1c4f31b908fd_9039c9a3-bb63-4ff8-ba48-1896ea84b208.html,,,,,, "4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one]",3520-72-7," In the “Combined Repeated Dose Oral Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test” of the structure analogue Pigment Orange 34, the no observed adverse effect level (NOAEL) is considered to be 1000 mg/kg body weight/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0dc3e75b-9240-4141-98c1-32cb494301f3/documents/1e428b1b-21f6-4965-ba8f-6c2ec674ba97_869bcb77-338c-43a3-82e1-56bfa898fea2.html,,,,,, "4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one]",3520-72-7," Oral: LD50 (Pigment Orange 13, nano form) >2100 mg/kg LD50 (strucrue analogue Pigment Orange 34, nano form) >15000 mg/kg   Inhalation: Waiving   Dermal: LD50 (strucrue analogue Pigment Orange 38, nano form) >2000 mg/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0dc3e75b-9240-4141-98c1-32cb494301f3/documents/5918b366-a9e4-4845-9d69-b5f544503277_869bcb77-338c-43a3-82e1-56bfa898fea2.html,,,,,, "4,4'-[(6-chloro-1,3,5-triazine-2,4-diyl)diimino]bis[5-hydroxy-6-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonic] acid, sodium salt",94158-79-9,The test substance is practically non-toxic ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5ada9bf-d9d0-4f45-9ec9-e0e902594de0/documents/IUC5-0ac90cf9-f9eb-45dd-a85b-da099b7edf11_0aee00da-d02a-41ea-b093-085729767561.html,,,,,, "4,4'-[(6-chloro-1,3,5-triazine-2,4-diyl)diimino]bis[5-hydroxy-6-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonic] acid, sodium salt",94158-79-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5ada9bf-d9d0-4f45-9ec9-e0e902594de0/documents/IUC5-0ac90cf9-f9eb-45dd-a85b-da099b7edf11_0aee00da-d02a-41ea-b093-085729767561.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4,4'-[(isopropylidene)bis(p-phenyleneoxy)]diphthalic dianhydride",38103-06-9," ORAL Under the conditions of the study, the no-observed adverse-effect level (NOAEL) for the test material was considered to be 1000 mg/kg bw/day for males and females rats when dosed via oral gavage for 28 days. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d4316d8-fb15-4deb-bcce-e809b512b39c/documents/IUC5-4a9ef1f0-d8f6-4f03-888a-0bd881faa0bc_9366346c-4d8d-4d5c-9e10-c156ad382a18.html,,,,,, "4,4'-[(isopropylidene)bis(p-phenyleneoxy)]diphthalic dianhydride",38103-06-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d4316d8-fb15-4deb-bcce-e809b512b39c/documents/IUC5-4a9ef1f0-d8f6-4f03-888a-0bd881faa0bc_9366346c-4d8d-4d5c-9e10-c156ad382a18.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4,4'-[(isopropylidene)bis(p-phenyleneoxy)]diphthalic dianhydride",38103-06-9, ORAL An acute oral gavage study in male and female rats performed according to US EPA Toxic Substance Control Act (TSCA) Health Effects Test Guidelines indicated an LD50 of >5000 mg/kg-bw. DERMAL An acute dermal toxicity study in male and female rabbits performed according to US EPA TSCA Health Effects Test Guidelines indicated an LD50 of >2000 mg/kg-bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d4316d8-fb15-4deb-bcce-e809b512b39c/documents/IUC5-a3158d13-f052-46a9-a39d-344438d88285_9366346c-4d8d-4d5c-9e10-c156ad382a18.html,,,,,, "4,4'-[(isopropylidene)bis(p-phenyleneoxy)]diphthalic dianhydride",38103-06-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d4316d8-fb15-4deb-bcce-e809b512b39c/documents/IUC5-a3158d13-f052-46a9-a39d-344438d88285_9366346c-4d8d-4d5c-9e10-c156ad382a18.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "4,4'-[(isopropylidene)bis(p-phenyleneoxy)]diphthalic dianhydride",38103-06-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d4316d8-fb15-4deb-bcce-e809b512b39c/documents/IUC5-a3158d13-f052-46a9-a39d-344438d88285_9366346c-4d8d-4d5c-9e10-c156ad382a18.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-[1,3-phenylenebis(azo)]bisbenzene-1,3-diamine",1052-38-6,"NOAEL, oral, rat, OECD 422 = 60 mg/kg bw /dayLOAEL, oral, rat, OECD 422 = 240 mg/kg bw /day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00a58c82-d41e-4e2c-a4ab-b109297efc0b/documents/IUC5-06e8c8dd-7d0a-4011-8551-577548253aee_7af4aa06-ff51-4ebd-a30d-ea1f406669dd.html,,,,,, "4,4'-[1,3-phenylenebis(azo)]bisbenzene-1,3-diamine",1052-38-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00a58c82-d41e-4e2c-a4ab-b109297efc0b/documents/IUC5-06e8c8dd-7d0a-4011-8551-577548253aee_7af4aa06-ff51-4ebd-a30d-ea1f406669dd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat "4,4'-[1,3-phenylenebis(azo)]bisbenzene-1,3-diamine",1052-38-6,"LD50, oral, rat, (m/f) > 2698 mg/kg bw (BASF, 1979)LC50, inhalation, rat (m/f) > 5610 mg/m3 (BASF, 1978) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00a58c82-d41e-4e2c-a4ab-b109297efc0b/documents/IUC5-77e37142-b53c-4924-a6a2-431756150f36_7af4aa06-ff51-4ebd-a30d-ea1f406669dd.html,,,,,, "4,4'-[1,3-phenylenebis(azo)]bisbenzene-1,3-diamine",1052-38-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00a58c82-d41e-4e2c-a4ab-b109297efc0b/documents/IUC5-77e37142-b53c-4924-a6a2-431756150f36_7af4aa06-ff51-4ebd-a30d-ea1f406669dd.html,,oral,LD50,"2,698 mg/kg bw",no adverse effect observed, "4,4'-[1,3-phenylenebis(azo)]bisbenzene-1,3-diamine",1052-38-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00a58c82-d41e-4e2c-a4ab-b109297efc0b/documents/IUC5-77e37142-b53c-4924-a6a2-431756150f36_7af4aa06-ff51-4ebd-a30d-ea1f406669dd.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF",1478-61-1, Subacute repeat oral dose toxicity study (OECD 407): NOAEL 10 mg/kg bw/day (Umano 2012) Combined repeat dose toxicity study with reproductive toxicity screening (OECD 422): NOAEL 30 mg/kg/day; Anon (2011) ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d20a1a9a-5686-4996-9180-0c9d1aa0af6c/documents/fc8c346a-9e83-4647-b62e-fbf918ddacc8_6f3bb841-605a-48b4-9061-38db41506e75.html,,,,,, "4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF",1478-61-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d20a1a9a-5686-4996-9180-0c9d1aa0af6c/documents/fc8c346a-9e83-4647-b62e-fbf918ddacc8_6f3bb841-605a-48b4-9061-38db41506e75.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF",1478-61-1,"Acute Oral Toxicity: LD50 (rats, combined) ≥ 2000 mg/kg bw; OECD 420; Anon. (2001a) Acute Inhalation Toxicity: Waiver Acute Dermal Toxicity: LD50 (rats, combined) ≥ 2000 mg/kg bw; OECD 402; Anon. (2001b) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The endpoint is concluded based on a single key study with a Klimisch rating of 1. No effects were observed up to the limit dose of 2000 mg/kg bw. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The acute inhalation toxicity study was waived in accordance with Annex VIII, Section 8.5.2, Column 2. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The endpoint is concluded based on a single key study with a Klimisch rating of 1. No effects were observed up to the limit dose of 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d20a1a9a-5686-4996-9180-0c9d1aa0af6c/documents/50259c99-55b1-4792-a45d-d4e72e8e4846_6f3bb841-605a-48b4-9061-38db41506e75.html,,,,,, "4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF",1478-61-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d20a1a9a-5686-4996-9180-0c9d1aa0af6c/documents/50259c99-55b1-4792-a45d-d4e72e8e4846_6f3bb841-605a-48b4-9061-38db41506e75.html,,oral,LD50,">=2,000 mg/kg bw",no adverse effect observed, "4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphenol; bisphenol AF",1478-61-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d20a1a9a-5686-4996-9180-0c9d1aa0af6c/documents/50259c99-55b1-4792-a45d-d4e72e8e4846_6f3bb841-605a-48b4-9061-38db41506e75.html,,dermal,LD50,">=2,000 mg/kg bw",no adverse effect observed, "4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphthalic anhydride",1107-00-2,"The Acute Oral Toxicity potential of 6FDA was evaluated by obtaining predictions using T.E.S.T “Oral LD50 rat” QSAR model and ProTox “Oral Acute Toxicity (Rodent)” QSAR model. The predictions were obtained using the nearest neighbour method based on the structural similarity between analogue substances with known LD50 and the target chemical 6FDA. The T.E.S.T. model predicted an LD50 (rat) for 6FDA of 1637.93 mg/kg bw and the ProTox model estimated an LD50 (rodent) of 1900 mg/kg bw for 6FDA. The values ranged from 300 to 2000 mg/kg bw, so according to the criteria established in the CLP Regulation, 6FDA can be expected to be classified as Acute Toxicity Category 4. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4f7a9ab-259c-4168-a5e0-54d7679ae409/documents/361bf693-0368-490f-a925-0d7704cef6f9_9d0adcce-2bd1-4a41-a0d0-a7c91ca16fb1.html,,,,,, "4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]diphthalic anhydride",1107-00-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4f7a9ab-259c-4168-a5e0-54d7679ae409/documents/361bf693-0368-490f-a925-0d7704cef6f9_9d0adcce-2bd1-4a41-a0d0-a7c91ca16fb1.html,,oral,LD50,"1,637.93 mg/kg bw",adverse effect observed, "4,4'-[vinylenebis[(3-sulpho-4,1-phenylene)imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]bis[5-hydroxy-6-[(1-sulpho-2-naphthyl)azo]naphthalene-2,7-disulphonic] acid",94022-69-2," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target substance 4,4'-[vinylenebis[(3-sulpho-4,1-phenylene)imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]bis[5-hydroxy-6-[(1-sulpho-2-naphthyl)azo] naphthalene-2,7-disulphonic] acid (94022-69-4) was estimated to be 8717.93 mg/kg bw,and for different studies available on the structurally similar read across substance 2,7 Naphthalendisulfonic acid (3861-73-2) was considered to be >5000 mg/kg bw and for 1,5-Naphthalenedisulfonicacid, 2-(6-(4,6-dichlorostriazinyl) methylamino-1-hydroxy-3-sulfonaphthylazo)-) (73816-75-8) was considered to be 8500 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 4,4'-[vinylenebis[(3-sulpho-4,1-phenylene)imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]bis[5-hydroxy-6-[(1-sulpho-2-naphthyl)azo] naphthalene-2,7-disulphonic] acid (94022-69-4) cannot be classified for acute oral toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75cd9bbf-389c-4347-80f7-3b82655f0ac3/documents/c36fe4c1-ad33-4d84-8e0e-8ef2105f0803_241946db-0000-49f4-b393-6079a327539e.html,,,,,, "4,4'-[vinylenebis[(3-sulpho-4,1-phenylene)imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]bis[5-hydroxy-6-[(1-sulpho-2-naphthyl)azo]naphthalene-2,7-disulphonic] acid",94022-69-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75cd9bbf-389c-4347-80f7-3b82655f0ac3/documents/c36fe4c1-ad33-4d84-8e0e-8ef2105f0803_241946db-0000-49f4-b393-6079a327539e.html,,oral,LD50,"8,717.93 mg/kg bw",no adverse effect observed, "4,4'-azobis[4-cyanovaleric] acid",2638-94-0, The NOAEL for general systemic toxicity was 1000 mg/kg bw/d for male and female Wistar rats after repeated application. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa4b7b65-da46-4980-9b78-c0af8809d416/documents/5d7470ce-322b-4575-a487-3ac330162116_8fe68120-a8bc-42a8-b034-35ecf20fb243.html,,,,,, "4,4'-azobis[4-cyanovaleric] acid",2638-94-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa4b7b65-da46-4980-9b78-c0af8809d416/documents/5d7470ce-322b-4575-a487-3ac330162116_8fe68120-a8bc-42a8-b034-35ecf20fb243.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4,4'-azobis[4-cyanovaleric] acid",2638-94-0, Based on a study according to OECD Guideline 423 in rats the oral LD50 of the test item was determined to be > 2000 mg/kg bw. Based on a study according to OECD Guideline 402 in rats the dermal LD50 of the test item was determined to be > 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa4b7b65-da46-4980-9b78-c0af8809d416/documents/4b3d8f51-ce59-45b0-b484-7ed749e6b8d0_8fe68120-a8bc-42a8-b034-35ecf20fb243.html,,,,,, "4,4'-azobis[4-cyanovaleric] acid",2638-94-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa4b7b65-da46-4980-9b78-c0af8809d416/documents/4b3d8f51-ce59-45b0-b484-7ed749e6b8d0_8fe68120-a8bc-42a8-b034-35ecf20fb243.html,,oral,discriminating dose,200 mg/kg bw,adverse effect observed, "4,4'-azobis[4-cyanovaleric] acid",2638-94-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa4b7b65-da46-4980-9b78-c0af8809d416/documents/4b3d8f51-ce59-45b0-b484-7ed749e6b8d0_8fe68120-a8bc-42a8-b034-35ecf20fb243.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4,4'-benzylidenedianiline",603-40-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 (OECD TG 420 & GLP) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ca27275-f359-450e-a97d-1653ecd21e63/documents/6bdd0552-13b6-4eaf-a76a-76cc30cac0b4_ba2b7896-a506-40d0-85e6-07c89a1e5fc7.html,,,,,, "4,4'-biphthalic dianhydride",2420-87-3,"The test substance is of low oral acute toxicity with an oral LD50 ( rat) of > 2000 mg/kg bw (SafePharm Lab 2004). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is valid without restriction (Klimisch 1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10d9dfa3-904f-4d79-adb5-5010caf30e75/documents/cb08c902-da6c-426b-80dd-a80aaaa4f8e4_7340de00-b87c-4a2c-b4b9-d6451b1a3fc6.html,,,,,, "4,4'-biphthalic dianhydride",2420-87-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10d9dfa3-904f-4d79-adb5-5010caf30e75/documents/cb08c902-da6c-426b-80dd-a80aaaa4f8e4_7340de00-b87c-4a2c-b4b9-d6451b1a3fc6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-bis(chloromethyl)-1,1'-biphenyl",1667-10-3," Acute Oral Toxicity Under the conditions of this study, the acute oral LD50 value of the test item was found to be above 2000 mg/kg bw in female Crl:WI rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/484cc2e4-bbe6-4ba6-b9ed-86054adb90ee/documents/dffdf063-3166-4dc9-9b9f-c9ee21c71796_094378d6-b061-4a95-8f2a-a2dc6fed6182.html,,,,,, "4,4'-bis(chloromethyl)-1,1'-biphenyl",1667-10-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/484cc2e4-bbe6-4ba6-b9ed-86054adb90ee/documents/dffdf063-3166-4dc9-9b9f-c9ee21c71796_094378d6-b061-4a95-8f2a-a2dc6fed6182.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-bis(diethylamino)benzophenone",90-93-7,"Guideline study conducted to GLP. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 1 ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/457109f0-6220-4a59-8e4c-a1277fabe088/documents/c468368c-a9dd-4f06-8672-3542a140ec60_51d37500-80b6-4416-ad09-d87777ca694d.html,,,,,, "4,4'-bis(diethylamino)benzophenone",90-93-7,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/457109f0-6220-4a59-8e4c-a1277fabe088/documents/c468368c-a9dd-4f06-8672-3542a140ec60_51d37500-80b6-4416-ad09-d87777ca694d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4,4'-bis(diethylamino)benzophenone",90-93-7, The acute oral toxicity of the substance was investigated in a relaible in vivo study in which the substance was given by oral gavage at a single dose of 2000 mg/kg bw to female Wistar rats. The oral LD50 value of the substance in Wistar rats was established to exceed 2000 mg/kg body weight. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/457109f0-6220-4a59-8e4c-a1277fabe088/documents/b6b32c54-5b7b-4478-9eb2-74e912cd413f_51d37500-80b6-4416-ad09-d87777ca694d.html,,,,,, "4,4'-bis(diethylamino)benzophenone",90-93-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/457109f0-6220-4a59-8e4c-a1277fabe088/documents/b6b32c54-5b7b-4478-9eb2-74e912cd413f_51d37500-80b6-4416-ad09-d87777ca694d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-bis(diethylamino)benzophenone",90-93-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/457109f0-6220-4a59-8e4c-a1277fabe088/documents/b6b32c54-5b7b-4478-9eb2-74e912cd413f_51d37500-80b6-4416-ad09-d87777ca694d.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol",561-41-1,"Repeated dose oral toxicity: Based on all the available observations and results, it was concluded that the No Observed Adverse Effect Level (NOAEL) and Low Observed Adverse Effect Level (LOAEL) of the test chemical in the Sprague Dawley rat via oral route, was found to be 25 mg/kg body weight and 50 mg/kg body weight, respectively in male and female animals.   Repeated dose Inhalation toxicity: 4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol(CAS no 561-41-1)has very low vapor pressure (0.00000000052 Paat 25˚C), so the potential for the generation of inhalable vapours is very low.The particle size distribution was determined to be in the range of53 to 250 micrometer.Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver   Repeated dose dermal toxicity: The acute dermal toxicity value for4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol (CAS no 561-41-1) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/02691114-5a40-494c-a58f-fa5846678af9/documents/9395c091-0bdb-448d-84dd-6aab57a91c12_c7118114-75de-49ef-be50-7a2f51ab9c9d.html,,,,,, "4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol",561-41-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/02691114-5a40-494c-a58f-fa5846678af9/documents/9395c091-0bdb-448d-84dd-6aab57a91c12_c7118114-75de-49ef-be50-7a2f51ab9c9d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat "4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol",561-41-1,"Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on experimental studies conducted on rats for the test chemical. The LD50 value is between 300-2000 mg/kg bw for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified as “Category IV” for acute oral toxicity.   Acute Inhalation Toxicity: In accordance with column 2 of Annex VIII, this end point was considered for waiver since the vapour pressure of 4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol is very low (0.00000000052 Pa) and thus there is no possibility of exposure by the inhalation route in this case. Also, considering that the particle size of this chemical ranges between 53 to 250 micrometer in size; there is no possibility of inhalable dust particles (size usually in nano meters) being generated during the use.   Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on experimental study report conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02691114-5a40-494c-a58f-fa5846678af9/documents/05dce07e-2155-4f76-b071-c59531c5c16d_c7118114-75de-49ef-be50-7a2f51ab9c9d.html,,,,,, "4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol",561-41-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02691114-5a40-494c-a58f-fa5846678af9/documents/05dce07e-2155-4f76-b071-c59531c5c16d_c7118114-75de-49ef-be50-7a2f51ab9c9d.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, "4,4'-bis(dimethylamino)-4''-(methylamino)trityl alcohol",561-41-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02691114-5a40-494c-a58f-fa5846678af9/documents/05dce07e-2155-4f76-b071-c59531c5c16d_c7118114-75de-49ef-be50-7a2f51ab9c9d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-bis[4-[bis(2-hydroxyethyl)amino]-6-anilino-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonic acid",4404-43-7,Oral NOAEL: 542 mg/kg bw/day (chronic; rat) ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6f1dd68-4553-44a4-818d-cf89de4a7551/documents/IUC5-fc4ca486-9393-4071-a210-733dc2f09a35_27a172d4-8f99-4884-bc1a-78bd82e0db62.html,,,,,, "4,4'-bis[4-[bis(2-hydroxyethyl)amino]-6-anilino-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonic acid",4404-43-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6f1dd68-4553-44a4-818d-cf89de4a7551/documents/IUC5-fc4ca486-9393-4071-a210-733dc2f09a35_27a172d4-8f99-4884-bc1a-78bd82e0db62.html,Chronic toxicity – systemic effects,oral,NOAEL,542 mg/kg bw/day,,rat "4,4'-bis[4-[bis(2-hydroxyethyl)amino]-6-anilino-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonic acid",4404-43-7,Rat oral LD50 > 15000 mg/kg bwRat inhalation LC50 > 1895 mg/m3 ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6f1dd68-4553-44a4-818d-cf89de4a7551/documents/IUC5-eacb5242-b53d-4676-8494-65ee00d2779e_27a172d4-8f99-4884-bc1a-78bd82e0db62.html,,,,,, "4,4'-bis[4-[bis(2-hydroxyethyl)amino]-6-anilino-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonic acid",4404-43-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6f1dd68-4553-44a4-818d-cf89de4a7551/documents/IUC5-eacb5242-b53d-4676-8494-65ee00d2779e_27a172d4-8f99-4884-bc1a-78bd82e0db62.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "4,4'-bis[4-[bis(2-hydroxyethyl)amino]-6-anilino-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonic acid",4404-43-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6f1dd68-4553-44a4-818d-cf89de4a7551/documents/IUC5-eacb5242-b53d-4676-8494-65ee00d2779e_27a172d4-8f99-4884-bc1a-78bd82e0db62.html,,inhalation,LC50,"1,895 mg/m3",no adverse effect observed, "4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride",6358-36-7," Repeated dose toxicity: oral The No Observed Adverse Effect Level (NOAEL) for Calcozine YeIlow SPF Unblended is considered to be 100 mg/Kg bw/day. Repeated dose toxicity: inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride, which is reported as 0.00000000015 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical 4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride  is highly unlikely. Therefore this study is considered for waiver. Repeated dse toxicity: dermal The acute toxicity value for 4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride (as provided in section 7.2.3) is >2000 mg/kg body weight. Thus, it is expected that 4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6f469f1-1645-48d0-9a60-9429c7d5d13d/documents/107b0e35-13eb-4795-be5e-413b9af15767_6bb364f1-8432-4bd3-a2ab-9c715413244d.html,,,,,, "4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride",6358-36-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6f469f1-1645-48d0-9a60-9429c7d5d13d/documents/107b0e35-13eb-4795-be5e-413b9af15767_6bb364f1-8432-4bd3-a2ab-9c715413244d.html,Chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride",6358-36-7," Acute oral toxicity: Under the condition of the study, the acute oral LD50 (Cut-off value) of 4, 4’-carbonimidoylbis [N,N-diethylaniline] monohydrochloride (CAS No. 6358-36-7) was 300 mg/kg body weight. Thus, it was concluded that the acute toxicity study of 4, 4’-carbonimidoylbis [N,N-diethylaniline] monohydrochloride (CAS No. 6358-36-7), when administered via oral route in Sprague Dawley rats falls into the “Category 3 (50 – ≤ 300)” criteria of CLP. Acute inhalation toxicity: The study need not be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Acute dermal toxicity: It was concluded that the acute dermal median lethal dose (LD50) of 4, 4’-carbonimidoylbis [N,N-diethylaniline] monohydrochloride (CAS No. 6358-36-7), when administered to male and female Sprague Dawley rats was found to be greater than 2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that 4, 4’-carbonimidoylbis [N,N-diethylaniline] monohydrochloride (CAS No. 6358-36-7) does not classify as an acute dermal toxicant.   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6f469f1-1645-48d0-9a60-9429c7d5d13d/documents/c29c8595-4c0d-4e7a-a9cc-a33420bd585f_6bb364f1-8432-4bd3-a2ab-9c715413244d.html,,,,,, "4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride",6358-36-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6f469f1-1645-48d0-9a60-9429c7d5d13d/documents/c29c8595-4c0d-4e7a-a9cc-a33420bd585f_6bb364f1-8432-4bd3-a2ab-9c715413244d.html,,oral,LD50,50 mg/kg bw,adverse effect observed, "4,4'-carbonimidoylbis[N,N-diethylaniline] monohydrochloride",6358-36-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6f469f1-1645-48d0-9a60-9429c7d5d13d/documents/c29c8595-4c0d-4e7a-a9cc-a33420bd585f_6bb364f1-8432-4bd3-a2ab-9c715413244d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-cyclohexylidenedi-o-cresol",2362-14-3," ORAL Systemic toxicity NOAEL 1000 mg/kg/day, reproductive/developmental toxicity NOAEL 1000 mg/kg/day, rat (male/female); OECD 422 ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/39e64b4c-b6f0-4b9a-a4ed-f096a9e49a11/documents/IUC5-7b9d5002-64b8-4a84-97d6-5d5af67ceb18_59f4f075-05f1-4a65-92b2-01a11e98438c.html,,,,,, "4,4'-cyclohexylidenedi-o-cresol",2362-14-3,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/39e64b4c-b6f0-4b9a-a4ed-f096a9e49a11/documents/IUC5-7b9d5002-64b8-4a84-97d6-5d5af67ceb18_59f4f075-05f1-4a65-92b2-01a11e98438c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4,4'-cyclohexylidenedi-o-cresol",2362-14-3, ORAL LD50 > 2000 mg/kg bw in the rat (male/female); OECD 423 and EPA OPPTS 870.1100 DERMAL LD50 > 2000 mg/kg bw in the rabbit (male/female); OECD 402 and EPA 870.1200 ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39e64b4c-b6f0-4b9a-a4ed-f096a9e49a11/documents/IUC5-d4aedc4b-e092-4d5e-a204-12b18aa01018_59f4f075-05f1-4a65-92b2-01a11e98438c.html,,,,,, "4,4'-cyclohexylidenedi-o-cresol",2362-14-3,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39e64b4c-b6f0-4b9a-a4ed-f096a9e49a11/documents/IUC5-d4aedc4b-e092-4d5e-a204-12b18aa01018_59f4f075-05f1-4a65-92b2-01a11e98438c.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4,4'-cyclohexylidenedi-o-cresol",2362-14-3,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39e64b4c-b6f0-4b9a-a4ed-f096a9e49a11/documents/IUC5-d4aedc4b-e092-4d5e-a204-12b18aa01018_59f4f075-05f1-4a65-92b2-01a11e98438c.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4,4'-diamino[1,1'-bianthracene]-9,9',10,10'-tetraone",4051-63-2,No indication of systemic uptake after ingestion at the limit dose of 1000 mg/kg bw was observed in a GLP compliant study with rats following OECD testing guideline 422 (BASF 2013). ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98c76d13-d477-467e-b36d-084ce6ac9c5b/documents/f1cace36-110c-4819-88c2-7fc9569a09d7_81814516-124c-44eb-a646-9c187f4b5427.html,,,,,, "4,4'-diamino[1,1'-bianthracene]-9,9',10,10'-tetraone",4051-63-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98c76d13-d477-467e-b36d-084ce6ac9c5b/documents/f1cace36-110c-4819-88c2-7fc9569a09d7_81814516-124c-44eb-a646-9c187f4b5427.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4,4'-diamino[1,1'-bianthracene]-9,9',10,10'-tetraone",4051-63-2,The substance did not cause adverse effects upon a single oral dose of 10000 mg/kg bw in rats in a study design similar to that of OECD guideline 423 (BASF 1973). It did not cause acute dermal toxicity at the limit dose of 2000 mg/kg bw in a GLP compliant study following OECD guideline 402 (BASF 2012a). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98c76d13-d477-467e-b36d-084ce6ac9c5b/documents/dfef7d32-9834-4db5-ae83-dc5857372046_81814516-124c-44eb-a646-9c187f4b5427.html,,,,,, "4,4'-diamino[1,1'-bianthracene]-9,9',10,10'-tetraone",4051-63-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98c76d13-d477-467e-b36d-084ce6ac9c5b/documents/dfef7d32-9834-4db5-ae83-dc5857372046_81814516-124c-44eb-a646-9c187f4b5427.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "4,4'-diamino[1,1'-bianthracene]-9,9',10,10'-tetraone",4051-63-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98c76d13-d477-467e-b36d-084ce6ac9c5b/documents/dfef7d32-9834-4db5-ae83-dc5857372046_81814516-124c-44eb-a646-9c187f4b5427.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4,4'-diaminostilbene-2,2'-disulphonic acid",81-11-8,oral (rat): >3000 mg/kg bw (m+f)oral (guinea pig): >4700 mg/kg bw (m+f)intraperitoneal (rat): >3000 mg/kg bw (m+f) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fad04109-2286-4577-ae3d-64fdae9de1cb/documents/IUC5-b32000a9-126a-4720-97e6-b3b162e70699_235dc4bc-b311-45cd-b13a-a58847f68997.html,,,,,, "4,4'-diaminostilbene-2,2'-disulphonic acid",81-11-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fad04109-2286-4577-ae3d-64fdae9de1cb/documents/IUC5-b32000a9-126a-4720-97e6-b3b162e70699_235dc4bc-b311-45cd-b13a-a58847f68997.html,,oral,LD50,"3,000 mg/kg bw",, "4,4'-dihydroxy-7,7'-iminodi(naphthalene-2-sulphonic acid)",87-03-6, Acute oral toxicity: LD50 value was estimated to be 3755 mg/kg bw for rats when treated with 4-hydroxy-7-[(5-hydroxy-7-sulfonaphthalen-2-yl)amino]naphthalene-2-sulfonic acid orally. Acute dermal toxicity: LD50 value was estimated to be 7026 mg/kg bw for rabbits. when treated with 4-hydroxy-7-[(5-hydroxy-7-sulfonaphthalen-2-yl)amino]naphthalene-2-sulfonic acid by dermal application. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c982d76f-60dd-44cc-8aae-7b166b2e1b7a/documents/4d8b9f67-9a51-41b9-97e6-5618868af77d_f95439b7-08f7-43e1-889e-a8f5a105dad7.html,,,,,, "4,4'-dihydroxy-7,7'-iminodi(naphthalene-2-sulphonic acid)",87-03-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c982d76f-60dd-44cc-8aae-7b166b2e1b7a/documents/4d8b9f67-9a51-41b9-97e6-5618868af77d_f95439b7-08f7-43e1-889e-a8f5a105dad7.html,,oral,LD50,"3,755 mg/kg bw",no adverse effect observed, "4,4'-dihydroxy-7,7'-iminodi(naphthalene-2-sulphonic acid)",87-03-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c982d76f-60dd-44cc-8aae-7b166b2e1b7a/documents/4d8b9f67-9a51-41b9-97e6-5618868af77d_f95439b7-08f7-43e1-889e-a8f5a105dad7.html,,dermal,LD50,"7,026 mg/kg bw",no adverse effect observed, "4,4'-dihydroxybenzophenone",611-99-4,"A 2024, GLP compliant study was performed according to OECD 422 (combined approach, oral dosing). The analytical method used to verify dose concentrations had intrinsic carry over which was seen in the results. The carry over was declared and minimal so as to not affect the integrity of the study. There were two unscheduled kills during the study; one female in Group 3 (300 mg/kg bw/day) and one female in Group 4 (1000 mg/kg bw/day). Both unscheduled kills were considered to be events of euthanasia, on humane grounds and under the provision limits of the licence of the laboratory for the undertaking of scientific procedures on animals. Both animals were female. The conclusion of the study was that there were no treatment-related effects for females other than the two incidents of euthanasia which were performed on the basis of bodyweight loss and severe clinical signs. Neither bodyweight loss nor clinical signs were considered to be attributable to treatment by the Study Director in the conclusions of the report. No post-mortem findings which were considered to be related to treatment or causative of the moribund state were declared. The Study Director concludes that the unscheduled kill in Group 3 is not related to treatment. The Study Director concludes that as, ""similar findings of body weight loss with associated low food consumption were noted in surviving females at 300 and 1000 mg/kg/day, these observations were considered related to treatment with the test material though morbidity cannot be concluded on."" which defies the conclusion of no adverse effects in these parameters. Therefore, these effects have been taken into account in the determination of the sublethal NOAEL. Since moribundity (and the reason supporting euthanasia) could not be attributed to treatment, it is considered that the NOAEL (mortality) should be 1000 mg/kg bw/day and not 300 mg/kg bw/day as stated in the final report.   NOAEL (mortality) 1000 mg/kg bw /day [male, female] NOAEL (food consumption & bodyweight) 300 mg/kg bw /day [male, female] ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b90b4bd-f04a-4d7b-b7bc-2f61cddb90ed/documents/faedd450-89f4-4b2f-a021-2533b5414c97_c6fbc412-d008-4bc8-9522-0a9ff2d526e3.html,,,,,, "4,4'-dihydroxybenzophenone",611-99-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b90b4bd-f04a-4d7b-b7bc-2f61cddb90ed/documents/faedd450-89f4-4b2f-a021-2533b5414c97_c6fbc412-d008-4bc8-9522-0a9ff2d526e3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "4,4'-dihydroxybenzophenone",611-99-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b90b4bd-f04a-4d7b-b7bc-2f61cddb90ed/documents/faedd450-89f4-4b2f-a021-2533b5414c97_c6fbc412-d008-4bc8-9522-0a9ff2d526e3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane",57280-22-5,"Study conducted according to OECD test guideline 407; 6 female/male Wistar rats were administered Trioxabicyclooctane at doses of 0, 40, 200 and 1000 mg/kg bw/d for 28 consecutive days, result: NOAEL= 40 mg/kg bw/d Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline study, high reliability ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ec24987-ce29-4b67-9999-0d46ec11f83d/documents/67f21dfd-e710-40bd-9eea-ede69a86f07f_041209f2-d386-4d13-b00f-c2cbeb875fbf.html,,,,,, "4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane",57280-22-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ec24987-ce29-4b67-9999-0d46ec11f83d/documents/67f21dfd-e710-40bd-9eea-ede69a86f07f_041209f2-d386-4d13-b00f-c2cbeb875fbf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat "4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane",57280-22-5,"Study conducted according to OECD test guideline 401,male and female rats (5/sex/group) were treated with 2000 mg/kg bw of the test item by oral gavage, result: not classified Study conducted according to OECD test guideline 402,groups of young adult Wistar rats (3/sex) were dermally exposed to Trioxabicyclooctan (100 % a.i) in 0.9% NaCl (750 mg/mL) for 24 hours at dose of 2000 mg/kg bw, result: not classified ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ec24987-ce29-4b67-9999-0d46ec11f83d/documents/68f47da5-daad-4e6d-9c6f-8a2f0925575c_041209f2-d386-4d13-b00f-c2cbeb875fbf.html,,,,,, "4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane",57280-22-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ec24987-ce29-4b67-9999-0d46ec11f83d/documents/68f47da5-daad-4e6d-9c6f-8a2f0925575c_041209f2-d386-4d13-b00f-c2cbeb875fbf.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4,4-dimethyl-3,5,8-trioxabicyclo[5.1.0]octane",57280-22-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ec24987-ce29-4b67-9999-0d46ec11f83d/documents/68f47da5-daad-4e6d-9c6f-8a2f0925575c_041209f2-d386-4d13-b00f-c2cbeb875fbf.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4,4'-dioxo-4,4'-dioxydibutyric acid",123-23-9," The acute oral LD50 of the test item in the male rat was determined to be 3257 mg/kg. If the rat were female, the oral LD50 was determined to be 2646 mg/kg. In the sexes combined, the oral LD50 was determined to be 3100 mg/kg. The acute dermal LD50 of the test item was estimated to be greater than 2000 mg/kg in the rat. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8d7eaaa-4ea5-4365-ba14-2a85dee74cdc/documents/1231b9b8-c168-4095-9bf1-ca4eab7ab4f5_08555cc3-dad3-4346-a88f-2c0a3d658d01.html,,,,,, "4,4'-dioxo-4,4'-dioxydibutyric acid",123-23-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8d7eaaa-4ea5-4365-ba14-2a85dee74cdc/documents/1231b9b8-c168-4095-9bf1-ca4eab7ab4f5_08555cc3-dad3-4346-a88f-2c0a3d658d01.html,,oral,LD50,"3,100 mg/kg bw",adverse effect observed, "4,4'-dioxo-4,4'-dioxydibutyric acid",123-23-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8d7eaaa-4ea5-4365-ba14-2a85dee74cdc/documents/1231b9b8-c168-4095-9bf1-ca4eab7ab4f5_08555cc3-dad3-4346-a88f-2c0a3d658d01.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4,4'-isopropylidenebis[2-allylphenol]",1745-89-7,In an Oral (Gavage) Combined Repeat Dose Toxicity Study with Reproduction/Developmental Toxicity Screening Test in the Rat (OECD 422) the NOAEL for systemic toxicity was found to be 85 mg/kg/day. Effects were noted at 250 mg/kg/day. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/904e18c5-dc5e-4323-af2d-2d23d1eccdff/documents/IUC5-61d4532b-f41a-4b4d-a6c7-08aed83d9641_0d624723-bb92-4749-a0ee-4b88217ad4c4.html,,,,,, "4,4'-isopropylidenebis[2-allylphenol]",1745-89-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/904e18c5-dc5e-4323-af2d-2d23d1eccdff/documents/IUC5-61d4532b-f41a-4b4d-a6c7-08aed83d9641_0d624723-bb92-4749-a0ee-4b88217ad4c4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,85 mg/kg bw/day,,rat "4,4'-isopropylidenebis[2-allylphenol]",1745-89-7,"1)The acute oral toxicity study was performed to assess the acute oral toxicity of the test item in the rat.2)The acute dermal toxicity study was performed to asses the acute dermal toxicty of the test item, (TK 11907), in the rat. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/904e18c5-dc5e-4323-af2d-2d23d1eccdff/documents/IUC5-117472ad-f121-4498-aced-abc6c20b467a_0d624723-bb92-4749-a0ee-4b88217ad4c4.html,,,,,, "4,4'-isopropylidenebis[2-allylphenol]",1745-89-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/904e18c5-dc5e-4323-af2d-2d23d1eccdff/documents/IUC5-117472ad-f121-4498-aced-abc6c20b467a_0d624723-bb92-4749-a0ee-4b88217ad4c4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-isopropylidenebis[2-allylphenol]",1745-89-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/904e18c5-dc5e-4323-af2d-2d23d1eccdff/documents/IUC5-117472ad-f121-4498-aced-abc6c20b467a_0d624723-bb92-4749-a0ee-4b88217ad4c4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-isopropylidenedi-2,6-xylol",5613-46-7,"In a GLP/ OECD Guideline 422 study (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), TMBPA was administered by gavage once daily at 0, 10, 100, or 1000 mg/kg bw/d to parental F0 male and female rats, 12/sex/group. In addition, 5 additional males per group included in the 0 and 1000 mg/kg bw/d dose groups were designated as recovery animals and held without dosing for two weeks after the dosing period. Under the conditions of this study, the No-Observable-Adverse-Effect-Level (NOAEL) for systemic parental toxicity via the oral route was 10 mg/kg bw/d based on clinical findings, mean body weight losses or significant reductions in body weight gains and lower mean food consumption at 100 and 1000 mg/kg bw/d and minimal to mild vacuolation of the lamina propria in the duodenum and jejunum noted in the 100 (duodenum only) and 1000 mg/kg/day group F0 males and females at the primary necropsy and the persistence of minimal vacuolation in the duodenum and jejunum at slightly higher incidence in the 1000 mg/kg/day group F0 males at the recovery necropsy. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e858f6d-3ab8-4ffb-9a98-2efa1325b9e0/documents/IUC5-f8ceaade-7d23-4fb6-9a4b-535b729f7c06_6f13e175-5527-4eca-b336-0cb8d52d0f1a.html,,,,,, "4,4'-isopropylidenedi-2,6-xylol",5613-46-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e858f6d-3ab8-4ffb-9a98-2efa1325b9e0/documents/IUC5-f8ceaade-7d23-4fb6-9a4b-535b729f7c06_6f13e175-5527-4eca-b336-0cb8d52d0f1a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "4,4'-isopropylidenedi-2,6-xylol",5613-46-7,"Acute toxicity (oral) Under the conditions of this study, the LD50 of the test material was determined to be greater than 2000 mg/kg bw.   Acute toxicity (dermal) Under the conditions of this study, the LD50 of the test material was determined to be greater than 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e858f6d-3ab8-4ffb-9a98-2efa1325b9e0/documents/IUC5-60cfdf05-b63f-4228-b4a7-594a1eeb9dc5_6f13e175-5527-4eca-b336-0cb8d52d0f1a.html,,,,,, "4,4'-isopropylidenedi-2,6-xylol",5613-46-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e858f6d-3ab8-4ffb-9a98-2efa1325b9e0/documents/IUC5-60cfdf05-b63f-4228-b4a7-594a1eeb9dc5_6f13e175-5527-4eca-b336-0cb8d52d0f1a.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4,4'-isopropylidenedi-2,6-xylol",5613-46-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e858f6d-3ab8-4ffb-9a98-2efa1325b9e0/documents/IUC5-60cfdf05-b63f-4228-b4a7-594a1eeb9dc5_6f13e175-5527-4eca-b336-0cb8d52d0f1a.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4,4'-Isopropylidenedicyclohexanol, oligomeric reaction products with 1-chloro-2,3-epoxypropane",30583-72-3," The oral administration of 2,2'-[(1-Methylethylidene)bis(cyclohexane-4,1-diyloxymethylene)]-bisoxirane (Eponex 1510) to rats by gavage, at dose level of 600 mg/kg bw/day, resulted in the early deaths of three males.  Treatment-related changes in this treatment group included reductions in body weight development and dietary intake (males only), increased water consumption and histopathological changes in the kidneys, bone, adrenal glands, thymus, liver, ovaries, vagina, seminal vesicles.  Mineralisation was also present in occasional tissues. The findings detected at 100 mg/kg bw/day were considered to be more adaptive in nature and under the conditions of this study a No Observed Adverse Effect Level (NOAEL) for either sex can be considered to be 100 mg/kg bw/day for systemic toxicity ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/951d235f-b027-4da2-9e5a-52af1ccce864/documents/IUC5-13204f61-8ce7-44a4-a74d-a63abe70d641_d9c8afe8-9aec-4e51-9317-1114eda26a74.html,,,,,, "4,4'-Isopropylidenedicyclohexanol, oligomeric reaction products with 1-chloro-2,3-epoxypropane",30583-72-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/951d235f-b027-4da2-9e5a-52af1ccce864/documents/IUC5-13204f61-8ce7-44a4-a74d-a63abe70d641_d9c8afe8-9aec-4e51-9317-1114eda26a74.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "4,4'-Isopropylidenedicyclohexanol, oligomeric reaction products with 1-chloro-2,3-epoxypropane",30583-72-3,"The test substance, 4,4'-Isopropylidenedicyclohexanol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, was evaluated for acute toxicity to rats in an O.E.C.D. test guideline 425 oral study and an O.E.C.D. test guideline 402 acute dermal study. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/951d235f-b027-4da2-9e5a-52af1ccce864/documents/IUC5-aaa5c936-81a4-4770-b2fe-cf246ae698a3_d9c8afe8-9aec-4e51-9317-1114eda26a74.html,,,,,, "4,4'-isopropylidenedi-o-cresol",79-97-0," OECD Guideline, GLP-compliant 28-day repeated dose study via oral route. The animals (male/female) were administered with a single daily dose of the test substance by gavage for 28 days. Some effects were noted at the highest tested dose (1000 mg/kg), however, these were judged to be not toxicologically significant and therefore the NOEAL was set at 1000 mg/kg accordingly. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f7ab45ad-1b24-4b76-8f39-4f6b3d9610a9/documents/0355d39a-db17-483d-9fbd-d36d433090cb_f006a87d-04e0-43b7-9fbd-09190106d138.html,,,,,, "4,4'-isopropylidenedi-o-cresol",79-97-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f7ab45ad-1b24-4b76-8f39-4f6b3d9610a9/documents/0355d39a-db17-483d-9fbd-d36d433090cb_f006a87d-04e0-43b7-9fbd-09190106d138.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4,4'-isopropylidenedi-o-cresol",79-97-0," OECD guideline, GLP-compliant study for acute oral toxicity via the oral route was conducted. No mortality or adverse findings were recorded during the study period. The LD50 was determined to be greater than the highest dose administered (>2000 mg/kg). No studies were available for acute toxicity via the dermal or inhalation route. Oral exposure was deemed the only relevant route of exposure for this substance within the EU/EEA. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7ab45ad-1b24-4b76-8f39-4f6b3d9610a9/documents/2265d6b8-cf1e-4399-ba4f-db300af5837a_f006a87d-04e0-43b7-9fbd-09190106d138.html,,,,,, "4,4'-Isopropylidenediphenol, ethoxylated",32492-61-8,"A subchronic toxicity was performed on  4,4-isopropylidenediphenol, ethoxylated (BPA-4EO)  according to OECD Testing Guideline 408. On the basis of the absence of treatment-related adverse effects, it is proposed a NOAEL of 1000 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63fc0bef-1ac6-484c-bfe4-7b3de199c606/documents/1118e90e-a674-4d9f-817a-3a8db517f8ad_b6ad6f41-71cc-4b74-83a8-26b00bcce972.html,,,,,, "4,4'-Isopropylidenediphenol, ethoxylated",32492-61-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63fc0bef-1ac6-484c-bfe4-7b3de199c606/documents/1118e90e-a674-4d9f-817a-3a8db517f8ad_b6ad6f41-71cc-4b74-83a8-26b00bcce972.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4,4'-Isopropylidenediphenol, ethoxylated",32492-61-8,"In both the acute toxicity: oral and the acute toxicity: dermal studies the LD50 was >2000 mg/kg bw. The inhalation toxicity study demonstrated that, under the test conditions and at the maximum achievable test concentrations, the substance vapours were not toxic. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63fc0bef-1ac6-484c-bfe4-7b3de199c606/documents/IUC5-f492ef1b-3d05-497a-a92e-f24af3a713c9_b6ad6f41-71cc-4b74-83a8-26b00bcce972.html,,,,,, "4,4'-Isopropylidenediphenol, ethoxylated",32492-61-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63fc0bef-1ac6-484c-bfe4-7b3de199c606/documents/IUC5-f492ef1b-3d05-497a-a92e-f24af3a713c9_b6ad6f41-71cc-4b74-83a8-26b00bcce972.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4,4'-Isopropylidenediphenol, ethoxylated",32492-61-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63fc0bef-1ac6-484c-bfe4-7b3de199c606/documents/IUC5-f492ef1b-3d05-497a-a92e-f24af3a713c9_b6ad6f41-71cc-4b74-83a8-26b00bcce972.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco",115340-85-7, The actual NOAEL is > 1000 mg/kg bw. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1d500c15-b288-4515-9d94-e9aba4560c88/documents/be63b7e2-a559-4718-8784-d8bd541c6f4e_d1db19ce-788d-4ffd-9c7b-29bb55dcc4f7.html,,,,,, "4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco",115340-85-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1d500c15-b288-4515-9d94-e9aba4560c88/documents/be63b7e2-a559-4718-8784-d8bd541c6f4e_d1db19ce-788d-4ffd-9c7b-29bb55dcc4f7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco",115340-85-7," The substance 4, 4'­lsopropylidenediphenol, ethoxylated, esters with fatty acids, coco, did not show acute oral or acute dermal toxicity. Exposure of humans by the inhalation route is unlikely. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d500c15-b288-4515-9d94-e9aba4560c88/documents/b0042fc5-2a9c-4f38-a2fb-729530d8100a_d1db19ce-788d-4ffd-9c7b-29bb55dcc4f7.html,,,,,, "4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco",115340-85-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d500c15-b288-4515-9d94-e9aba4560c88/documents/b0042fc5-2a9c-4f38-a2fb-729530d8100a_d1db19ce-788d-4ffd-9c7b-29bb55dcc4f7.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "4,4'-Isopropylidenediphenol, ethoxylated, esters with fatty acids, coco",115340-85-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d500c15-b288-4515-9d94-e9aba4560c88/documents/b0042fc5-2a9c-4f38-a2fb-729530d8100a_d1db19ce-788d-4ffd-9c7b-29bb55dcc4f7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with [(dimethylamino)methyl]phenol and piperazine",159034-96-5," Short-term repeated dose toxicity: oral The test item was repeatedly administered by oral gavage at 0 (control group), 110, 330 and 1000 mg/kg to male and female Crl:CD(SD) rats for 28 days to assess the toxicological effects of test item and its reversibility by observing functional and morphological changes based on OECD 407. As there was foam cells noted in the ileum, mesenteric lymph node and lung of males or females receiving 110 mg/kg or more, NOAEL could not be determined in this study. However, as the number of occurrence and the degree of the change decreased almost in proportion to lower dose of test item, the dose of 110 mg/kg was considered proximal to LOAEL. Short-term repeated dose toxicity: Dermal and inhalation Waived as s a reliable oral toxicity study is available. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16b9bb8a-2b40-44db-9fe7-dd2a0e7498a1/documents/1d95ef11-4edc-4a0f-8c61-cd82b51f568a_bd74a80b-0b81-442f-88f7-70028f85472c.html,,,,,, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with [(dimethylamino)methyl]phenol and piperazine",159034-96-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16b9bb8a-2b40-44db-9fe7-dd2a0e7498a1/documents/1d95ef11-4edc-4a0f-8c61-cd82b51f568a_bd74a80b-0b81-442f-88f7-70028f85472c.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,110 mg/kg bw/day,,rat "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with [(dimethylamino)methyl]phenol and piperazine",159034-96-5, The acute oral median lethal dose (LD50) of the test item in the female Sprague Dawley strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System - Unclassified). The acute dermal median lethal dose (LD50) of the test item in the Sprague Dawley strain rat was found to be greater than 2000 mg/kg body weight. Inhalation study was waived as this is not an expected route of exposure. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16b9bb8a-2b40-44db-9fe7-dd2a0e7498a1/documents/ec3cd69c-7a39-496b-ba48-b9cbd1266dd1_bd74a80b-0b81-442f-88f7-70028f85472c.html,,,,,, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with [(dimethylamino)methyl]phenol and piperazine",159034-96-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16b9bb8a-2b40-44db-9fe7-dd2a0e7498a1/documents/ec3cd69c-7a39-496b-ba48-b9cbd1266dd1_bd74a80b-0b81-442f-88f7-70028f85472c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with [(dimethylamino)methyl]phenol and piperazine",159034-96-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16b9bb8a-2b40-44db-9fe7-dd2a0e7498a1/documents/ec3cd69c-7a39-496b-ba48-b9cbd1266dd1_bd74a80b-0b81-442f-88f7-70028f85472c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with 3-aminomethyl-3,5,5-trimethylcyclohexylamine",38294-64-3," 90 d NOAEL = 10 mg/kg bw/d (rat, oral: gavage; 0, 10, 100, 200 mg/kg bw/day): death of one male treated with 200 mg/kg bw/day, clinical signs of toxicity, reduced body weight development and food consumption, changes in the hematology parameters measured and microscopic changes in the mesenteric lymph nodes ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c545104-2416-4a41-bc64-bd756a9720d0/documents/IUC5-78a755a6-ee37-4f13-aa98-3e78fab6a26c_7bc16faa-431a-42e5-a782-9ca1a7c6a76a.html,,,,,, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with 3-aminomethyl-3,5,5-trimethylcyclohexylamine",38294-64-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c545104-2416-4a41-bc64-bd756a9720d0/documents/IUC5-78a755a6-ee37-4f13-aa98-3e78fab6a26c_7bc16faa-431a-42e5-a782-9ca1a7c6a76a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with 3-aminopropyldiethylamine and 2-piperazin-1-ylethylamine",68698-70-4,"The oral LD50 of 4,4’-Isopropylidenediphenyl, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with cyclohex-1,2-ylenediamine is greater than 300 mg/kg but less than 1000 mg/kg of body weight in rats and considered to be in GHS Category 4. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2d4733a-21a7-4712-8108-cccf4d529ca6/documents/ee2c0e79-9933-43b7-bc29-990752883716_b8ea4359-80de-4457-aa89-9a2948707aa0.html,,,,,, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with 3-aminopropyldiethylamine and 2-piperazin-1-ylethylamine",68698-70-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2d4733a-21a7-4712-8108-cccf4d529ca6/documents/ee2c0e79-9933-43b7-bc29-990752883716_b8ea4359-80de-4457-aa89-9a2948707aa0.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with biphenyl-4-ol",161308-15-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The rat 28d oral toxicity study is the only study available. The study has been performed under GLP and according to OECD guideline 407. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/ccc6c49c-4260-448c-90d3-1e965a61a6d5/documents/IUC5-05758777-eb5b-452c-9397-bcb5295a6184_125014be-ef7c-4de2-978c-e41672dea28e.html,,,,,, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with biphenyl-4-ol",161308-15-2,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/ccc6c49c-4260-448c-90d3-1e965a61a6d5/documents/IUC5-05758777-eb5b-452c-9397-bcb5295a6184_125014be-ef7c-4de2-978c-e41672dea28e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with biphenyl-4-ol",161308-15-2,"LD50(oral, rat): >2000 mg/kg body weight;LD50(dermal, rat): >2000 mg/kg body weight ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccc6c49c-4260-448c-90d3-1e965a61a6d5/documents/IUC5-82dc73b1-c32b-476f-8039-a27a275f9e27_125014be-ef7c-4de2-978c-e41672dea28e.html,,,,,, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with biphenyl-4-ol",161308-15-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccc6c49c-4260-448c-90d3-1e965a61a6d5/documents/IUC5-82dc73b1-c32b-476f-8039-a27a275f9e27_125014be-ef7c-4de2-978c-e41672dea28e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with biphenyl-4-ol",161308-15-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccc6c49c-4260-448c-90d3-1e965a61a6d5/documents/IUC5-82dc73b1-c32b-476f-8039-a27a275f9e27_125014be-ef7c-4de2-978c-e41672dea28e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with cyclohex-1,2-ylenediamine",87041-44-9,"The oral LD50 of 4,4’-Isopropylidenediphenyl, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with cyclohex-1,2-ylenediamine was tested in an OECD 423 study (MB Research 2017). The LD50 value is greater than 1000 mg/kg but less than 2000 mg/kg of body weight in rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d60f81f-0a29-475e-bd54-c7a251a8ba36/documents/f6be752c-b608-4bea-b4eb-3931319bc90e_11bbacb4-6a10-4b1a-9735-099b95dee6cd.html,,,,,, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with cyclohex-1,2-ylenediamine",87041-44-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d60f81f-0a29-475e-bd54-c7a251a8ba36/documents/f6be752c-b608-4bea-b4eb-3931319bc90e_11bbacb4-6a10-4b1a-9735-099b95dee6cd.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with m-phenylenebis(methylamine)",113930-69-1," 90 d NOAEL = 10 mg/kg bw/d (rat, oral: gavage; 0, 10, 100, 300 mg/kg bw/day): death of one female treated with 300 mg/kg bw/day, early termination of two females and one male treated with 300 mg/kg bw/day, clinical signs of toxicity, reduced body weight development and food consumption (300 mg/kg bw/day males only), changes in hematology parameters (300 mg/kg bw/day males only) and microscopic changes in the mesenteric lymph nodes.  ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f70c50da-bd79-4116-8993-921f3d2d20d3/documents/IUC5-c3110951-c103-4ba6-b362-62ffd927708d_9189fe8e-6217-4985-9abb-2fa7995a8a97.html,,,,,, "4,4'-Isopropylidenediphenol, oligomeric reaction products with 1-chloro-2,3-epoxypropane, reaction products with m-phenylenebis(methylamine)",113930-69-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f70c50da-bd79-4116-8993-921f3d2d20d3/documents/IUC5-c3110951-c103-4ba6-b362-62ffd927708d_9189fe8e-6217-4985-9abb-2fa7995a8a97.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "4,4'-Isopropylidenediphenol, polymer with 1-chloro-2,3-epoxypropane, propane-1,2-diol acrylate and succinic anhydride",68958-77-0,"Based on the results of an OECD TG 408 compliant 90-day repeated toxicity study with the read across substance BADGEDA, the NOAEL of the test substance for systemic effects is considered to be below the lowest tested dose level of 100 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/84630b28-0d38-4887-b434-88b2edfa754e/documents/2f531114-be46-46d1-8fde-17c8c128bb6b_bf7d7a7a-1b0e-4e5c-a01b-774d39614007.html,,,,,, "4,4'-Isopropylidenediphenol, polymer with 1-chloro-2,3-epoxypropane, propane-1,2-diol acrylate and succinic anhydride",68958-77-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/84630b28-0d38-4887-b434-88b2edfa754e/documents/2f531114-be46-46d1-8fde-17c8c128bb6b_bf7d7a7a-1b0e-4e5c-a01b-774d39614007.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat "4,4'-Isopropylidenediphenol, polymer with 1-chloro-2,3-epoxypropane, propane-1,2-diol acrylate and succinic anhydride",68958-77-0,"Based on the results of acute oral, dermal and inhalation toxicity studies, the test substance is considered to be of low acute toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84630b28-0d38-4887-b434-88b2edfa754e/documents/26f160b6-15bc-4ac4-a17a-fdb35bfe84a9_bf7d7a7a-1b0e-4e5c-a01b-774d39614007.html,,,,,, "4,4'-Isopropylidenediphenol, polymer with 1-chloro-2,3-epoxypropane, propane-1,2-diol acrylate and succinic anhydride",68958-77-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84630b28-0d38-4887-b434-88b2edfa754e/documents/26f160b6-15bc-4ac4-a17a-fdb35bfe84a9_bf7d7a7a-1b0e-4e5c-a01b-774d39614007.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-Isopropylidenediphenol, polymer with 1-chloro-2,3-epoxypropane, propane-1,2-diol acrylate and succinic anhydride",68958-77-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84630b28-0d38-4887-b434-88b2edfa754e/documents/26f160b6-15bc-4ac4-a17a-fdb35bfe84a9_bf7d7a7a-1b0e-4e5c-a01b-774d39614007.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-Isopropylidenediphenol, polymer with 1-chloro-2,3-epoxypropane, propane-1,2-diol acrylate and succinic anhydride",68958-77-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84630b28-0d38-4887-b434-88b2edfa754e/documents/26f160b6-15bc-4ac4-a17a-fdb35bfe84a9_bf7d7a7a-1b0e-4e5c-a01b-774d39614007.html,,inhalation,LC50,"4,900 mg/m3",no adverse effect observed, "4,4'-Isopropylidenediphenol, propoxylated",37353-75-6," Investigation of the repeated-dose toxicity of the registered substance 4,4'-Isopropylidenediphenol, propoxylated (thereafter referred to as BPA PO) was performed in several steps. Based on the uses and exposure to the registered substance and its physicochemical properties (BPA PO has a vapour pressure << 1 Pa), the oral route was considered as the most relevant route of exposure for the purpose of the repeated-dose toxicity testing in accordance with Annexes VIII to X of REACH.   1.           Short-term repeated-dose toxicity Short-term (28-day) repeated-dose toxicity was performed as part of studies conducted in accordance with the OECD Testing Guideline 422 on BPA 2PO and Grade 5 of the registered substance.   1.1 Short-term repeated-dose toxicity study conducted on BPA 2PO The test substance was administered by daily oral gavage to male and female Wistar Han rats at dose levels of 125, 250 and 500 mg/kg bw/day. Males were exposed for 2 weeks prior to mating, during mating, and up to termination (for 29 days). The females were exposed for 2 weeks prior to mating, during mating, during post-coitum, and at least 4 days of lactation (for 43-54 days). Formulation analysis showed that the formulations were prepared accurately, were homogenous, and were stable for at least 6 hours at room temperature. Treatment related toxicity was evident at 250 and 500 mg/kg including mortality (3 animals at 250 mg/kg and 10 animals at 500 mg/kg), clinical signs (hunched posture, salivation, piloerection and lethargy, among others), changes in body weights, food consumption, haematology and clinical biochemistry parameters, and organ weight and organ to body weight ratios. Macroscopic and microscopic findings in the heart, stomach, brain, pituitary gland, kidneys, liver thymus, skeletal muscle, prostate gland, seminal vesicles, coagulation gland and ovaries were also noted. Additionally, impaired spermatogenesis were noted for males at 250 and 500 mg/kg bw/d. No toxicologically significant changes were noted in functional observations, and no toxicologically relevant effects were seen in any parameter at 125 mg/kg bw/d. In conclusion, treatment with BPA 2PO by oral gavage in male and female Wistar Han rats at dose levels of 125, 250 and 500 mg/kg body weight/day revealed parental toxicity at 250 and 500 mg/kg body weight/day.   1.2 Short-term toxicity study conducted on Grade 5 of BPA PO The test substance was administered by daily oral gavage to male and female Sprague-Dawley rats at dose levels of 30, 120 and 500 mg/kg bw/day. Males were exposed for 42 days. The females were exposed for 2 weeks prior to mating, during mating, during post-coitum, and at least 4 days of lactation (for 42-53 days). One female rat at 500 mg/kg bw/d died on day 39 (day 22 of pregnancy).Incidence of oestrous cycle disorder increased at 500 mg/kg bw/d. Transient salivation was observed at 120 and 500 mg/kg bw/d for both sexes. Emaciation was observed for both sexes at 500 mg/kg bw/d. Incidence of ptosis, decrease in locomotor activity and decrease in body weight gain was observed for male at 500 mg/kg bw/d. Some haematological changes observed at 500 mg/kg bw/d in males as well as in the 500 mg/kg bw/d male and female satellite groups. Neutrophil count was significantly lower in males from the high-dose group at the end of recovery period compared to control. Significant decrease in total protein was observed in male animals at 250 and 500 mg/kg, along with a significant decrease in albumin for male at 500 mg/kg bw/d and significant increase in total cholesterol for both sexes. During the urinalysis significantly higher levels of potassium levels in 50males from the high-dose group on week 2 of the recovery period. Absolute and relative weight of liver increased significantly for males at 500 mg/kg bw/d and relative weight increased for females at 500 mg/kg bw/d. Dilatation of lacteal in small intestine was observed at 500 mg/kg bw/d for both sexes. Hypertrophy of centrilobular hepatocyte was observed at 500 mg/kg bw/d for both sexes. Clinical chemistry changes and adaptive liver changes at 500 mg/kg bw/d were not considered as adverse. In conclusion, treatment with Grade 5 of BPA PO resulted in high rate of oestrus cycle disorder at 500 mg/kg bw/d.   2. Subchronic repeated-dose toxicity Investigation of the subchronic (90-day) repeated-dose toxicity of the registered substance was requested by the evaluating Competent Authority (eCA). A concern for systemic toxicity was identified in the OECD 422 study conducted with Grade 5 of BPA PO based on dilatation of lacteals, effects on the small intestine, and high rate of oestrus cycle disorder. This test substance was therefore considered as more relevant than BPA 2PO for the purpose of subsequent repeated-dose toxicity testing. However Grade 5 of BPA PO is regarded as a polymer under REACH, so it was a ruled out as a test substance for the purpose of the subchronic repeated-dose toxicity testing. The outcome of the Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening studies suggested that potential endocrine disruption properties could be related to a higher degree of propoxylation and constituents with higher chain-length. Therefore, Grade 4 of BPA PO was deemed as the most relevant test substance for this study by the eCA. The objective of this study was to evaluate the potential toxicity of the test item following daily oral administration (gavage) to rats for 13 weeks. On completion of the treatment period, designated animals were held for a 4‑week treatment‑free period in order to evaluate the reversibility of any findings. Two groups of 10 male and 10 female (low- and mid-doses) and one group of 15 male and 15 female (high-dose) Sprague-Dawley rats were treated daily by the oral route (gavage) with the test item, at dose-levels of 30, 120 or 500 mg/kg bw/d for 13 weeks. The test item was administered as an emulsion in the vehicle (olive oil) under a constant dosage-volume of 5 mL/kg/day. Another group of 15 male and 15 female Sprague-Dawley rats received the vehicle alone under the same experimental conditions and acted as a control group. The actual test item concentrations in the dose formulations prepared for use in Weeks 1, 4, 8 and 12 were determined using a HPLC with UV detection analytical method. The animals were observed daily for mortality and clinical signs. Detailed clinical examinations were performed weekly and a Functional Observation Battery (FOB) was conducted in Week 12. Body weight was recorded once pre-test, on the first day of treatment and then at least once a week. Food consumption was recorded once a week. Ophthalmology examinations were performed pre-test on all animals and at the end of the treatment period on all control- and high-dose animals. Haematology and blood biochemistry investigations were performed at the end of the treatment and treatment-free periods. On completion of the treatment or treatment-free periods, the animals were sacrificed and a full macroscopic post-mortem examination was performed. Designated organs were weighed and selected tissue specimens were preserved. A microscopic examination was performed on selected tissues for the control- and high-dose animals sacrificed at the end of the treatment period. A microscopic examination was also performed on selected tissues for the low- and intermediate-dose animals sacrificed at the end of the treatment period and for the control- and high‑dose animals sacrificed at the end of the treatment-free period. At 500 mg/kg bw/d, the test item induced adverse effects in males on the clinical condition, body weight and food consumption leading to premature sacrifice for ethical reasons. Slight to moderate changes in clinical pathology were also noted in both sexes. There were markedly higher liver weights in males and females that correlated with gross enlargement and microscopic hepatocellular hypertrophy, higher adrenal gland weights in males and females, correlated with the microscopic vacuolation of the adrenal cortex, higher kidney weights in females and decreased thymus weights in males correlated with the lymphoid atrophy. At gross examination, there were test item-related enlarged liver in 6/7 males that correlated with the hepatocellular hypertrophy. The black discoloration and the red discoloration correlated with microscopic centrilobular degeneration/necrosis and hemorrhage, respectively. The small seminal vesicles seen in 1/7 males correlated with acinar cell atrophy and decreased secretory content while the thickening the stomach from in 2/7 males treated at 500 mg/kg bw/d correlated with the mineralization and increased regeneration in the gland. At microscopic examination, there were adverse findings in the liver, urinary bladder and stomach from males treated at 500 mg/kg bw/d and non‑adverse findings in the pituitary gland, mandibular lymph nodes, mesenteric lymph nodes, mesenteric artery, thyroid glands, parathyroid, heart, lungs, adrenals, kidneys, jejunum, GALT, prostate and seminal vesicles, sternum, bone marrow, ovaries, vagina and thymus in males and/or, to a lesser extent, in females treated at 500 mg/kg bw/d. At the end of the treatment-free period, there were kidney and adrenal weight differences while there were no thymus or liver weights differences considered to be related to the test item administration. There were no test item-related gross findings while there were microscopic non-adverse findings in the liver (in males only), mesenteric lymph nodes, mesenteric artery, thyroid glands, heart (in males only), adrenals (in females only), kidneys, jejunum, sternum, bone marrow, and ovaries. These observations were considered to be non-adverse and suggested an incomplete reversibility of test item-related changes.  At 120 mg/kg bw/d, the test item induced lower body weight and food consumption in males and slight changes in blood biochemistry parameters in both sexes. There were non-adverse findings in the liver, adrenals, kidneys, jejunum, GALT, prostate and seminal vesicles and sternum.   At 30 mg/kg bw/d, the test item induced lower body weight in males and slight increase in cholesterol level in both sexes. There were non-adverse findings in the liver, prostate and seminal vesicles.   Consequently, under the experimental conditions of the study, based on adverse effect observed at 500 mg/kg bw/d in males, the No Observed Adverse Effect Level (NOAEL) after the 90-day treatment period was established at 120 mg/kg bw/d in males and at 500 mg/kg bw/d in female.   3.   Endocrine Disruption An independent scientific review was commissioned to identify evidences of endocrine disruption properties (as defined by the World Health Organization) for BPA PO, based on the studies performed on BPA 2PO and the various grades of the registered substance. The report is attached in Section 13 of the Dossier and a summary provided as part of the endpoint summary for the toxicity to reproduction. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c335920c-3184-495d-94ca-3f6f91f300b8/documents/IUC5-e6fdfc68-f07b-4571-b80c-42a730b55517_05dc1855-46d6-498e-8ad0-f6d4376b9e9f.html,,,,,, "4,4'-Isopropylidenediphenol, propoxylated",37353-75-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c335920c-3184-495d-94ca-3f6f91f300b8/documents/IUC5-e6fdfc68-f07b-4571-b80c-42a730b55517_05dc1855-46d6-498e-8ad0-f6d4376b9e9f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat "4,4'-Isopropylidenediphenol, propoxylated",37353-75-6," An oral limit test was performed on the BPA 2PO with 2/5 deaths in female and 0/5 males observed. Clinical signs were seen widely in the treated animals, but all surviving animals appeared normal at the end of the observation period with no histological findings. The animals that died showed effects to GI tract, lungs, liver and kidneys. A read-across study on BPA 2PO and a supporting study on BPA 5PO both gave an LD50>2,000 mg/kg bw. It was not considered appropriate to attempt an inhalation toxicity study as the substance is a viscous liquid with negligible vapour pressure. Acute dermal toxicity on BPA 5PO showed no clinical signs. There was a slight reduction in weight / weight gain in some animals and one rat showed transient slight irritation. The acute dermal LD50was >2000 mg/kg bw. Read across considered valid and further animal testing not justified. Justification for selection of acute toxicity – oral endpoint The key study was conducted in a GLP accredited laboratory according to OECD Testing Guideline 401. Justification for selection of acute toxicity – inhalation endpoint REACH Guidance Document R.7.a, Chapter. 7.4 Acute toxicity, indicates that in principle no inhalation studies are needed when vapour pressure < 0.1 Pa at 20°C or particle size > 100 µm. The substance is a viscous liquid with a very negligible vapour pressure at 20°C. The use of the substance is limited to industrial and professional users and does not involve the forming of aerosols, particles or droplets of an inhalable size. Exposure to humans via the inhalation route is considered unlikely to occur. Justification for selection of acute toxicity – dermal endpoint The study was conducted in a GLP accredited laboratory according to OECD Testing Guideline 402. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c335920c-3184-495d-94ca-3f6f91f300b8/documents/IUC5-86bd0e35-fd37-47cf-a963-03afaafe8fe3_05dc1855-46d6-498e-8ad0-f6d4376b9e9f.html,,,,,, "4,4'-Isopropylidenediphenol, propoxylated",37353-75-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c335920c-3184-495d-94ca-3f6f91f300b8/documents/IUC5-86bd0e35-fd37-47cf-a963-03afaafe8fe3_05dc1855-46d6-498e-8ad0-f6d4376b9e9f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-Isopropylidenediphenol, propoxylated",37353-75-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c335920c-3184-495d-94ca-3f6f91f300b8/documents/IUC5-86bd0e35-fd37-47cf-a963-03afaafe8fe3_05dc1855-46d6-498e-8ad0-f6d4376b9e9f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-isopropylidenediphenyl dicyanate",1156-51-0," Acute oral toxicity The study was performed according to the acute toxic class method (OECD 423 and EC B.1.Tris) in Wistar rats. Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As only one animal was found dead, a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group; therefore no further testing was required according to the testing guidelines.One animal was found dead after treatment at a dose level of 2000 mg/kg bw. Clinical observations included decreased activity (6/6), piloerection (6/6), hunched back (5/6) and prone position (3/6) and were observed on the day of treatment. The five surviving animals became symptom-free from the day after treatment. No effects were observed on body weights or body weight gains in any surviving animal during the study. Necropsy showed multifocal dark/red discoloration of the stomach glandular mucosa in the rat that died after treatment. This was considered to be test item-related. In addition, enlargement of the dark/red discoloured lungs, white foamy material in the trachea and light/red liquid material at the perinasal were also observed in this animal at necropsy. Following a 14 day observation period, no test item-related gross changes were recorded in the surviving rats Under the conditions of this study, the acute oral LD50 value of the test item was found to be above 2000 mg/kg bw in female Wistar rats. According the GHS criteria, LZ 514 can be classified as ""Category 5"" for acute oral exposure. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ab3d893-dda9-4d68-8d8b-95c0c7afffc5/documents/606bf6e4-7b5c-448e-bf8f-4b712a41ee14_96d0a5d4-5d55-4752-927f-f3acc27a304c.html,,,,,, "4,4'-isopropylidenediphenyl dicyanate",1156-51-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ab3d893-dda9-4d68-8d8b-95c0c7afffc5/documents/606bf6e4-7b5c-448e-bf8f-4b712a41ee14_96d0a5d4-5d55-4752-927f-f3acc27a304c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-methylene bis(dibutyldithiocarbamate)",10254-57-6," Oral: Daily administration of the test material by oral gavage to Han Wistar rats for 13 weeks resulted in low body weight gain over the treatment period in females receiving 330 or 1000 mg/kg/day. Changes in alkaline phosphatase, alanine aminotransferase, bile acid, creatinine, glucose, cholesterol, low density lipoproteins and albumin/globulin ratio were considered treatment related, and the slightly higher body weight adjusted liver, thyroid and parathyroid weights were considered to be treatment related, but none of these findings were considered toxicologically significant. Accumulation of hyaline droplets in the proximal convoluted tubules of the kidney was observed in males treated with 1000 mg/kg/day, a phenomenon specific to male rats that is not relevant to humans, and therefore, is considered non-adverse. Under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) is considered to be 1000 mg/kg/day. Inhalation: According to Column 2 of Annex VIII of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation repeated dose toxicity: inhalation route does not need to be conducted if exposure of humans via inhalation is unlikely taking into account the vapour pressure (<0.01 Pa at 20ºC is considered the cut off) and/or the possibility of exposure via particles of inhalable size. Methylenebis (dibutyldithiocarbamate) has a vapour pressure of <1.3E-08 Pa at 20 ºC, is a liquid at room temperature, and is placed upon the EU market incorporated as part of a liquid product. In addition, in an OECD 408 study, the No Observed Adverse Effect Level (NOAEL) is considered to be 1000 mg/kg/day. Therefore, based upon low human exposure potential and available study data, this endpoint is waived. Dermal: According to Column 2 of Annex VIII of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) legislation repeated dose toxicity: dermal route does not need to be conducted if exposure of humans is unlikely, taking into account any skin contact during production and the rate of absorption through the skin. Exposure of Methylenebis (dibutyldithiocarbamate) to humans via skin contact is considered minimal due to appropriate Risk Management Measures (RMM) identified in the Chemical Safety Report. In addition, in an OECD 408 study,the No Observed Adverse Effect Level (NOAEL) is considered to be 1000 mg/kg/day. Therefore, based upon low human exposure potential and available study data, this endpoint is waived. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5917a064-6090-403e-bc4f-931288219d55/documents/IUC5-c7215019-d66f-409b-99d1-b06700c8772d_9a5de295-9a2d-4c8a-8e27-e04feb8ac196.html,,,,,, "4,4'-methylene bis(dibutyldithiocarbamate)",10254-57-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5917a064-6090-403e-bc4f-931288219d55/documents/IUC5-c7215019-d66f-409b-99d1-b06700c8772d_9a5de295-9a2d-4c8a-8e27-e04feb8ac196.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4,4'-methylene bis(dibutyldithiocarbamate)",10254-57-6,"Oral:In this study, the acute oral LD50 is greater than 16.0 g/kg (Biosearch, Inc., 1980) Inhalation:The vapour pressure of Methylenebis (dibutyldithiocarbamate) is <1.3E-08 Pa at 20 ºC and there is no predicated inhalation exposure, therefore, this endpoint is waived.Dermal:In this study, the acute dermal LD50 is greater than 2.0 g/kg (Biosearch, Inc., 1980). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5917a064-6090-403e-bc4f-931288219d55/documents/IUC5-4b051c90-e7d4-4063-b203-4038d5104f68_9a5de295-9a2d-4c8a-8e27-e04feb8ac196.html,,,,,, "4,4'-methylene bis(dibutyldithiocarbamate)",10254-57-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5917a064-6090-403e-bc4f-931288219d55/documents/IUC5-4b051c90-e7d4-4063-b203-4038d5104f68_9a5de295-9a2d-4c8a-8e27-e04feb8ac196.html,,oral,LD50,"16,000 mg/kg bw",no adverse effect observed, "4,4'-methylene bis(dibutyldithiocarbamate)",10254-57-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5917a064-6090-403e-bc4f-931288219d55/documents/IUC5-4b051c90-e7d4-4063-b203-4038d5104f68_9a5de295-9a2d-4c8a-8e27-e04feb8ac196.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-methylenebis(2,6-xylidine)",4073-98-7," Acute toxicity, oral in rats: 300 mg/kg bw < LD50 < 2000 mg/kg bw (OECD 423, GLP, K, Rel. 1) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46dec7e8-28fa-4254-9a13-8ec039ac970f/documents/06676093-f83f-4b1a-addb-33fb2fdbea59_3118c1ab-259d-437d-876f-864966dc3b3e.html,,,,,, "4,4'-methylenebis(2,6-xylidine)",4073-98-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46dec7e8-28fa-4254-9a13-8ec039ac970f/documents/06676093-f83f-4b1a-addb-33fb2fdbea59_3118c1ab-259d-437d-876f-864966dc3b3e.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "4,4'-Methylene-bis-(3-chloro-2,6-diethylaniline)",106246-33-7," Subacute 28-day oral toxicity (feeding):     The study was performed 1987 as GLP-test following EC-test method B.7 on Sprague-Dawley rats. Application of test material was via diet, the dose levels were 0, 100, 300 and 1000 ppm. No deaths and no clinical signs of toxicity were noted. Laboratory findings included increased platelet counts in both sexes in the top dose group and slightly increased serum calcium in top dose females. Absolute and relative liver and adrenal weights were increased in both sexes in the top dose group only. The only effect seen microscopically was hypertrophy of the centrilobular cells of the liver. In conclusion, the NOEL was found to be 300 ppm (= 38 mg/kg/day).      Subchronic 90-day oral toxicity (feeding):    The study was performed 1996 as GLP-test following OECD-test method 408 on Sprague-Dawley rats. Application of test material was via diet, the dose levels were 0, 100, 300 and 1600 ppm. There were two unscheduled deaths, but no clinical signs of toxicity observed. There were effects observed on body weights, food efficiency haematology, biochemistry, organ weights and in macroscopic and microscopic pathology. The findings were noted mainly in the mid and high dose groups. No effects were seen on food consumption, water consumption, ophthalmoscopy and urinalysis. The microscopical findings were still present after a 4-week recovery period in females previously given 1600 ppm but there the incidences were not statistically significant from those of control rats.      Repeated dose inhalation toxicity:    The use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Furthermore, the results of laboratory animal studies show low acute dermal toxicity. In the 28-day and 90-day repeated dose study via oral administration does not exacerbate systemic toxicity effects which suggest bioavailability is low, thereby there is low toxicity potential. This intrinsic property/toxicity potential can be extrapolated to repeated inhalation route administration.     Repeated dose dermal toxicity:    The substance is unlikely to be inhaled, skin contact is unlikely and the physicochemical and toxicological properties suggest low potential for significant rate of absorption through the skin. Furthermore, the results of laboratory animal studies show low acute dermal toxicity. In the 28-day and 90-day repeated dose study via oral administration does not exacerbate systemic toxicity effects which suggest bioavailability is low, thereby there is low toxicity potential. This intrinsic property/toxicity potential can be extrapolated to repeated dermal route administration. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54acc930-bf1f-49a8-858d-dda0454bcffd/documents/IUC5-7fc7e7ab-aa52-4578-8c9b-ddb017b19b71_95277fd8-3b9c-46ea-bdda-b37821e20c2f.html,,,,,, "4,4'-Methylene-bis-(3-chloro-2,6-diethylaniline)",106246-33-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54acc930-bf1f-49a8-858d-dda0454bcffd/documents/IUC5-7fc7e7ab-aa52-4578-8c9b-ddb017b19b71_95277fd8-3b9c-46ea-bdda-b37821e20c2f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,38 mg/kg bw/day,,rat "4,4'-Methylene-bis-(3-chloro-2,6-diethylaniline)",106246-33-7," Acute oral toxicity: The study was performed 1988 as GLP-test following EU-testing method B.1. A pretest (screening) with five groups of 1 male & 1 female per dose level (250, 500, 1000, 2000 and 5000 mg/kg) was performed as DRF-study. The used species were Wistar rats. In the main study, 5 males and 5 females were treated with a single dose of 5000 mg/kg. The test item was dissolved in 1% aqueous methyl cellulose. One male died on day 8 after showing clinical symptoms. Necropsy examination of this animal showed effects in several organs. The remaining animals shower neither clinical signs nor effects on organs. In conclusion, the acute oral LD50 on both sexes was determined to be > 5000 mg/kg. Acute inhalation toxicity: Based on the low amount of inhalable particles (< 10 µm) of less than 10% and the use of the substance, the potential for the generation of inhalable forms is low, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur, and no acute inhalation test was performed. Acute dermal toxicity: The study was performed 1986 as GLP-test following EU-testing method B.3. The used species were Sprague-Dawley rats; 5 males and 5 females were treated with a single dose of 2000 mg/kg. The test item was moistened with distilled water and applied by occlusive dressing. Neither clinical signs nor effects on organs were noted. Body weight gains were lower than expected, particularly in females. In conclusion, the acute dermal LD50 was determined to be > 2000 mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54acc930-bf1f-49a8-858d-dda0454bcffd/documents/15e36214-99ee-4f18-8a5f-81726e78b817_95277fd8-3b9c-46ea-bdda-b37821e20c2f.html,,,,,, "4,4'-Methylene-bis-(3-chloro-2,6-diethylaniline)",106246-33-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54acc930-bf1f-49a8-858d-dda0454bcffd/documents/15e36214-99ee-4f18-8a5f-81726e78b817_95277fd8-3b9c-46ea-bdda-b37821e20c2f.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "4,4'-Methylene-bis-(3-chloro-2,6-diethylaniline)",106246-33-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54acc930-bf1f-49a8-858d-dda0454bcffd/documents/15e36214-99ee-4f18-8a5f-81726e78b817_95277fd8-3b9c-46ea-bdda-b37821e20c2f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-methylenebis(cyclohexylamine)",1761-71-3," The test substance was examined in a 28-day oral repeated dose toxicity study in Wistar rats. Treatment with the test substance by oral gavage in male and female Wistar Han rats at dose levels of 15, 50 and 100 mg/kg body weight/day revealed parental toxicity at 50 mg/kg bw characterized by microscopic findings in various organs and at 100 mg/kg body weight/day characterized by changes in body weights, food consumption, clinical biochemistry parameters, organ to body weight ratio changes and histopathological findings in various organs. Based on these results, the systemic NOAEL was 15 mg/kg bw/day (NOTOX, 2010). A sub-chronic toxicity study (90 days) does not need to be conducted because a reliable short-term toxicity study (28 days) is available showing severe toxicity effects according to the relevant criteria for classifying the substance, for which the observed NOAEL-28 days, with the application of an appropriate uncertainty factor, allows the extrapolation towards the NOAEL-90 days for the same route of exposure. A data waiver was claimed. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a82a9c2a-539a-4a3d-8da3-668774aebbcf/documents/IUC5-f1a32396-5790-421a-bdc1-2565f107f7b2_217d86c9-2831-4fa3-ad01-94cbf4c3ba87.html,,,,,, "4,4'-methylenebis(cyclohexylamine)",1761-71-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a82a9c2a-539a-4a3d-8da3-668774aebbcf/documents/IUC5-f1a32396-5790-421a-bdc1-2565f107f7b2_217d86c9-2831-4fa3-ad01-94cbf4c3ba87.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "4,4'-methylenebis(cyclohexylamine)",1761-71-3,"From reliable experimental studies, the LD50 for 4,4'-Methylenedicyclohexanamine has been established for oral and dermal routes of administration (Biosearch 1987). There are only insufficient data available so that no reliable LC50 for inhalation could be derived. However, due to the corrosive properties of the test material, no acute inhalation toxicity study has to be performed (see Waiver for acute inhalation toxicity). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): adequate Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): adequate ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a82a9c2a-539a-4a3d-8da3-668774aebbcf/documents/IUC5-21ca2c07-8077-4fa3-b0a0-483ec120a967_217d86c9-2831-4fa3-ad01-94cbf4c3ba87.html,,,,,, "4,4'-methylenebis(cyclohexylamine)",1761-71-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a82a9c2a-539a-4a3d-8da3-668774aebbcf/documents/IUC5-21ca2c07-8077-4fa3-b0a0-483ec120a967_217d86c9-2831-4fa3-ad01-94cbf4c3ba87.html,,oral,LD50,380 mg/kg bw,adverse effect observed, "4,4'-methylenebis(cyclohexylamine)",1761-71-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a82a9c2a-539a-4a3d-8da3-668774aebbcf/documents/IUC5-21ca2c07-8077-4fa3-b0a0-483ec120a967_217d86c9-2831-4fa3-ad01-94cbf4c3ba87.html,,dermal,LD50,"2,110 mg/kg bw",no adverse effect observed, "4,4'-methylenebis[2,6-diethylaniline]",13680-35-8," Under the conditions of the present study, LZ 596 caused slight reduction in body weight development and food consumption, changes in serum biochemical parameters (elevated gamma glutamyltransferase activity and cholesterol concentration – male and female – liver weight alterations along with cytoplasmic vacuolization in the liver lobes (male and female) following a consecutive 90 days oral administration at 50 mg/kg bw/day to Hsd.Brl.Han:Wistar rats. At 25 mg/kg bw/day, slightly elevated cholesterol concentration (female) and changes in liver weights and cytoplasmic vacuolization in the liver lobes (male and female) were detected. At 10 mg/kg bw/day, slightly elevated cholesterol concentration (female) and changes in liver weights (male and female) were observed. Based on the observations made in this toxicity study the dose levels for the No Observed Adverse Effect Levels (NOAEL) was determined as follows: - NOAEL for systemic toxicity of male rats: 10 mg/kg bw/day - NOAEL for systemic toxicity of female rats: 10 mg/kg bw/day The effects observed at dose levels of 25 and 10 mg/kg/day on body weights, food consumption, biochemistry and organ weights were treatment-related, however the changes were not severe and do not justify a classification for STOT Rep. Exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ae86d1c5-f200-4a26-a99c-1b9fd5dca9e6/documents/e7944ea5-8cca-4ec5-9460-5d9684c596a6_8cbc76e2-8330-41a5-b405-0607aa260447.html,,,,,, "4,4'-methylenebis[2,6-diethylaniline]",13680-35-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ae86d1c5-f200-4a26-a99c-1b9fd5dca9e6/documents/e7944ea5-8cca-4ec5-9460-5d9684c596a6_8cbc76e2-8330-41a5-b405-0607aa260447.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "4,4'-methylenebis[2,6-diethylaniline]",13680-35-8," Acute oral toxicity The acute oral toxicity was determined in a standard acute toxicity study according to OECD 401 and EC B.1 on male and female Wistar rats. In conclusion, the combined LD50 on Wistar rats was found to be 1901 mg/kg; the LD50 for males 1736 mg/kg and for females 2026 mg/kg. Acute inhalation toxicity Study was waived, because exposure of humans via inhalation is not likely taking into account vapor pressure and particle size of the substance. The test item is a solid at room temperature and usually handled as solid melt or in crystalline form. The content of inhalable particles of the crystalline material is very low. The particle size distribution of the crystalline material was found to be 125 - 500 μm. Less than 10% are <= 63 μm. Acute dermal toxicity An acute dermal toxicity study was performed with the test item in Crl:(WI)BR rats, in accordance with testing methods EC B.3 and OECD 402. Under the experimental conditions the acute dermal LD50 value of the test item LZ 596 proved to be greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae86d1c5-f200-4a26-a99c-1b9fd5dca9e6/documents/767a854c-d24e-4c73-a476-e1d73dbda46e_8cbc76e2-8330-41a5-b405-0607aa260447.html,,,,,, "4,4'-methylenebis[2,6-diethylaniline]",13680-35-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae86d1c5-f200-4a26-a99c-1b9fd5dca9e6/documents/767a854c-d24e-4c73-a476-e1d73dbda46e_8cbc76e2-8330-41a5-b405-0607aa260447.html,,oral,LD50,"1,901 mg/kg bw",adverse effect observed, "4,4'-methylenebis[2,6-diethylaniline]",13680-35-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae86d1c5-f200-4a26-a99c-1b9fd5dca9e6/documents/767a854c-d24e-4c73-a476-e1d73dbda46e_8cbc76e2-8330-41a5-b405-0607aa260447.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-methylenebis[N,N-bis(2,3-epoxypropyl)aniline]",28768-32-3,"TGMDA was administered daily to Sprague-Dawley rats, by oral gavage, at dose-levels of 10, 50 or 200 mg/kg/day for 13 weeks.Under the experimental conditions of this study, the No Observable Adverse Effect Level (NOAEL) was considered to be 50 mg/kg/day (based on clinical signs, decreased mean body weight and, hematology and clinical biochemistry findings at 200 mg/kg/day). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2b0f1b8-6db7-4738-98a6-5985687cb529/documents/73c04f0a-fc52-406b-9e51-3babca0adb4c_691779bc-f5b4-4528-a32c-c214ee80b38a.html,,,,,, "4,4'-methylenebis[N,N-bis(2,3-epoxypropyl)aniline]",28768-32-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2b0f1b8-6db7-4738-98a6-5985687cb529/documents/73c04f0a-fc52-406b-9e51-3babca0adb4c_691779bc-f5b4-4528-a32c-c214ee80b38a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "4,4'-methylenebis[N,N-bis(2,3-epoxypropyl)aniline]",28768-32-3,"No studies for the submission substance are available.All data presented were generated with a structural analogue substance, i.e. TGMDA-UVCB. The acute toxicity of the substance is low, the substance seems to be slowly absorbed by all routes and metabolized efficiently by epoxide hydrolases. The acute oral toxicity in rats (LD50) is > 5000 mg/kg body weight, and the acute dermal toxicity in rabbits is > 3000 mg/kg body weight.In both routes of exposure no signs of toxicity were recorded. Only during the oral test with a dose of 10'000 mg/kg body weight 1/2 animals died without any adverse effects observed during necropsy. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2b0f1b8-6db7-4738-98a6-5985687cb529/documents/b4070d5e-bc74-4ff4-bbe6-94d9b65869dc_691779bc-f5b4-4528-a32c-c214ee80b38a.html,,,,,, "4,4'-methylenebis[N,N-bis(2,3-epoxypropyl)aniline]",28768-32-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2b0f1b8-6db7-4738-98a6-5985687cb529/documents/b4070d5e-bc74-4ff4-bbe6-94d9b65869dc_691779bc-f5b4-4528-a32c-c214ee80b38a.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "4,4'-methylenebis[N,N-bis(2,3-epoxypropyl)aniline]",28768-32-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2b0f1b8-6db7-4738-98a6-5985687cb529/documents/b4070d5e-bc74-4ff4-bbe6-94d9b65869dc_691779bc-f5b4-4528-a32c-c214ee80b38a.html,,dermal,LD50,"> 3,000 mg/kg bw",no adverse effect observed, "4,4'-Methylenedianiline, oligomeric reaction products with 1-chloro-2,3-epoxypropane",28390-91-2,"There are no data available for the submission substance, i.e. TGMDA-UVCB. All data presented below is from the respective read-across substance (structural analogue), i.e. TGMDA. TGMDA was administered daily to Sprague-Dawley rats, by oral gavage, at dose-levels of 10, 50 or 200 mg/kg/day for 13 weeks.Under the experimental conditions of this study, the No Observable Adverse Effect Level (NOAEL) was considered to be 50 mg/kg/day (based on clinical signs, decreased mean body weight and, hematology and clinical biochemistry findings at 200 mg/kg/day).     ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33e64c93-0908-4746-8bd4-c5479f2ce781/documents/63a93b3c-1643-4813-bd0f-8a2ddf813be9_7dde345c-52a7-41d1-8a64-e4c24f959428.html,,,,,, "4,4'-Methylenedianiline, oligomeric reaction products with 1-chloro-2,3-epoxypropane",28390-91-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33e64c93-0908-4746-8bd4-c5479f2ce781/documents/63a93b3c-1643-4813-bd0f-8a2ddf813be9_7dde345c-52a7-41d1-8a64-e4c24f959428.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "4,4'-Methylenedianiline, oligomeric reaction products with 1-chloro-2,3-epoxypropane",28390-91-2,"The acute toxicity of the substance is is low, the substance seems to be slowly absorbed by all routes and metabolized efficiently by epoxide hydrolases. The acute oral toxicity in rats (LD50) is greater 5000 mg/kg body weight, the acute dermal toxicity in rabbits is >3000 mg/kg body weight, and the acute inhalation toxicity in rats (LC50)was measured to be >30 mg/m3 air (highest vapour concentration to be achieved technically). At all routes of exposure no signs of toxicity were recorded. Only during the oral test with a dose of 10'000 mg/kg body weight 1/2 animals died without any adverse effects observed during necropsy. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33e64c93-0908-4746-8bd4-c5479f2ce781/documents/9db6e7e8-f5ac-44e5-aeae-efa57b10b339_7dde345c-52a7-41d1-8a64-e4c24f959428.html,,,,,, "4,4'-Methylenedianiline, oligomeric reaction products with 1-chloro-2,3-epoxypropane",28390-91-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33e64c93-0908-4746-8bd4-c5479f2ce781/documents/9db6e7e8-f5ac-44e5-aeae-efa57b10b339_7dde345c-52a7-41d1-8a64-e4c24f959428.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "4,4'-Methylenedianiline, oligomeric reaction products with 1-chloro-2,3-epoxypropane",28390-91-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33e64c93-0908-4746-8bd4-c5479f2ce781/documents/9db6e7e8-f5ac-44e5-aeae-efa57b10b339_7dde345c-52a7-41d1-8a64-e4c24f959428.html,,dermal,LD50,"> 3,000 mg/kg bw",no adverse effect observed, "4,4'-Methylenedianiline, oligomeric reaction products with 1-chloro-2,3-epoxypropane",28390-91-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33e64c93-0908-4746-8bd4-c5479f2ce781/documents/9db6e7e8-f5ac-44e5-aeae-efa57b10b339_7dde345c-52a7-41d1-8a64-e4c24f959428.html,,inhalation,LC50,> 30 mg/m3,no adverse effect observed, "4,4'-Methylenediphenyl diisocyanate, oligomeric reaction products with 2,4'-diisocyanatodiphenylmethane",109331-54-6,"Description of Key information The test substance is part of a category approach of methylenediphenyl diisocyanates (MDI) with existing data gaps filled according to ECHA guidance on Read Across (ECHA, 2017).  The read-across category justification document is attached in IUCLID section 13 and summarized below in Additional Informaiton.  Data-gaps in this endpoint is satisfied by weight of evidence and read across from valid repeated dose toxicity studies for the inhalation route. Reliable repeated dose inhalation data in animals is available for the boundary substances (4,4’-MDI, pMDI and 4,4’-MDI/DPG/HMWP). The chronic repeated dose toxicity study (Reuzel et al. 1994, reliability 2) performed with pMDI is a guideline study (OECD 451). In addition, valid sub-chronic and sub-acute repeated dose toxicity studies are available  for pMDI (Reuzel et al. 1994, Kilgour et al. 2002, reliability 2). For the 4,4’-MDI a valid chronic inhalation toxicity study is available (Hoymann et al. 1995, reliability 2) and a limited documented sub-chronic inhalation toxicity study (Heinrich et al. 1991, reliability 4). For the boundary substance 4,4’-MDI/DPG/HMWP a sub-acute toxicity study is available (Ma-Hock, 2021, reliability 1).   Proposed Testing: To support this weight of evidence and read across approach additional repeated dose toxicity testing is planned. It is considered to perform a sub-chronic inhalation toxicity study (OECD 413) with boundary substance 4,4’-MDI/DPG/HMWP. Additional, combined Repeated Dose Toxicity studies with Reproductive/ developmental Toxicity Screening tests (OECD 422) will be performed on 9 substances representing all sub-groups and key structural/chemical characteristics (see overview attached in Annex 27 in Chapter 13). These screening studies will confirm the proposed MoA on repeated dose toxicity or identify substances that may require additional testing.   Available information: Several sub-acute, sub-chronic and chronic studies have been performed on 4,4’-MDI, pMDI and 4,4’-MDI/DPG/HMWP and are described in Category justification document in Chapter 13 . A repeated dose dermal toxicity study was performed in rabbits with pMDI (Wazeter et al., 1964a) but since this only has fourteen days of treatment and only slight local skin irritants effects were observed this is omitted from this chapter, but rather described in chapter addressing skin irritation. As with the acute studies, in all repeated dose studies, toxic effects were limited to the site of contact with no systemic effects observed distant from the portal of entry. Key repeated dose studies days are described below:  The ‘Monomeric MDI’ subgroup In a subchronic inhalation study with 4,4’-MDI, female Wistar rats were exposed to concentrations of MDI of 0, 0.3, 1 or 3 mg 4,4’-MDI/m3 for 18 hours a day on 5 days a week for 13-weeks. Reduced body weight gains and an increase in relative lung weights were found at 1 mg/m3 and above. At and above this concentration infiltration of mononuclear cells, goblet cell hyperplasia, erosion of the respiratory epithelium in the upper respiratory tract, hyperplasia of the bronchus-associated lymphatic tissue and inflammatory changes of the lung were additionally observed. At 3 mg/m3 there was an increase in the total cell count and proportion of granulocytes and lymphocytes, a decrease in the proportion of macrophages in the bronchoalveolar lavage fluid, an increase in protein, β-glucuronides and lactate dehydrogenase, and changes in lung function. No effects were observed at 0.3 mg/m3 (Heinrich et al., 1991). A subsequent chronic inhalation study (Hoymann et al., 1995) was conducted with 4,4’-MDI. Female Wistar rats were exposed to 0.23, 0.70 or 2.05 mg 4,4’-MDI/m³ aerosols for 17 hours/day, 5 days /week for up to 24 months. Essentially, a dose-dependent impairment of the lung function in terms of an obstructive-restrictive malfunction with diffusion disorder, increased lung weights, an inflammatory reaction with increased appearance of lymphocytes in the lung in the high dose group as a sign of specific stimulation of the immune system by MDI, an intermediately retarded lung clearance in the high dose group as well as dose-dependent interstitial and peribronchiolar fibrosis, alveolar bronchiolisations and a proliferation of the alveolar epithelium, which was classified as preneoplastic, as well as a bronchiolo-alveolar adenoma were identified. The LOAEC for the female rat was identified as 0.23 mg/m3 based on minor histopathological pulmonary lesions after long-term inhalation of 4,4'-MDI aerosols.  A comparison of the pulmonary effects described in female rats from the two chronic studies, one with 4,4’-MDI and the other with pMDI, was published by Feron et al. (2001). To assist the comparison and account for the lower proportion of mMDI in pMDI, the authors normalized the different MDI doses to total inhalation exposures calculated as 559; 1,972; 2,881; 6,001; 17,575 and 17,728 mg mMDI.h/m3. The major pulmonary effects in the two studies were characterized by hyperplasia, interstitial fibrosis and a low incidence of bronchiolo-alveolar adenoma, the latter occurring in the high exposure groups of both studies (i.e. total inhalation exposures of 17,728 and 17,575 mg.h/m3). Both studies also reported the presence of particle-laden macrophages predominantly in the alveoli close to the alveolar ducts which in some cases, particularly in high dose groups, were associated with areas of fibrosis. There was a clear quantitative dose response in both studies with the lowest dose of 559 mg mMDI.h/m3 from the study reported by Reuzel et al. (1994a) being described as the no-observed-adverse-effect-level (NOAEL) Feron et al. (2001) also suggested that the mild histopathological changes seen in the low exposure animals (0.23 mg/m3) in the Hoymann et al. (1995) study, would not have occurred if the exposure had been for six hours/day. An exposure of 0.2 mg/m3 over a six-hour period was judged to be the NOAEL in both studies. Overall, the analysis concluded that both studies showed similar qualitative responses to exposures to pMDI or 4,4’-MDI when compared on the basis of mMDI content..  The ‘Oligomeric MDI’ subgroup In a subacute inhalation study by Kilgour et al. (2002), female Alpk:APfSD rats were exposed to pMDI aerosol at  concentrations of 0, 1.0, 4.0 and 10 mg pMDI/m3, for 6 hours/day, 5 days/week, for  28 days, a 30-day recovery group was included. No clinical signs were noted during exposure and recovery phase. Body weights in all groups were comparable to controls throughout exposure and recovery periods. Lung weights were increased in animals exposed to 10 mg/m3 at the end of the exposure period, although this had returned to control values by day 30 post-exposure. Lung weights of all other treated groups were in the range of the control group. A dose-dependent influx of inflammatory cells, total protein levels and increase in enzyme activities indicated an inflammatory reaction. A statistically significant increase in both the total number of cells counted and alveolar macrophages in lavage fluid was noted at 10 mg/m3, and a slight (but not statistically significant) following exposure to 4 mg/m3. The polymorphonulear leukocytes (PMNs) and lymphocyte/other cells showed statistically significant, concentration-related increases in cell counts following exposure to 4 or 10 mg/m3 pMDI. At the end of the recovery phase, cell counts in exposed animals had returned to normal. Animals of the exposure groups 4 and 10 mg/m3 showed an increase of macrophages containing vacuoles (foamy macrophages), whereas the 1 mg/m3 group was in the range of the control animals. At the end of the recovery period few macrophages vacuoles were still discernable. In animal exposed to 10 mg/m3 pMDI a statistically significant increase in total protein and alkaline phosphatase activity was noted in lavage fluid at the end of exposure, whereas lactate dehydrogenase and N-acetyl glucosaminidase (NAG) activities were not increased. All other treated groups in the main study and all groups at the end of the recovery phase showed values similar to controls. A transient increase in phospholipids concentration was noted in the lavage fluid from animals exposed to 10 mg/m3 pMDI after exposure, no differences from control values were seen at the end of the recovery phase. In all exposure groups a statistically significant concentration-related increase in BrdU labelling index in terminal bronchioles were seen; a similar increase in centro-acinar alveoli were found in animals exposed to 4 and 10 mg/m3 pMDI. At the end of the recovery phase, labelling indices were similar to control values at all concentrations. No macroscopic abnormalities were noted. Histopathology of the lung showed in animals exposed to 10 mg/m3 pMDI an increase in bronchiolitis and thickening of the centro-acinar region, interstitial thickening at the acinar junctions, and accumulations of alveolar macrophages containing yellow pigment in the cytoplasm. In animals exposed to 4 mg/m3 pMDI 1/5 animals showed thickening of the centro-acinar region and bronchiolitis and 1/5 animals exposed to 1 mg/m3 pMDI showed bronchiolitis. After the recovery phase, alveolar macrophages containing a yellow pigment were present in the interstitium in all animals that had been exposed to 10 mg//m3 pMDI but were absent in animals exposed to 1 or 4 mg/m3 pMDI. In addition, 1/5 animals exposed to 10 mg/m3 pMDI still had bronchiolitis and centro-acinar thickening, but at a reduced severity and distribution to that seen in the main study. Ultrastructural findings suggest a perturbation of surfactant homeostasis by exposure to pMDI which is supported by the small increase in measured phospholipids and observation of foamy macrophages. Animals exposed to 10 mg/m3 pMDI showed a slight thickening of the interstitial alveolar wall in 3/5 animals. The thickening in the centro-acinar region was due to thickening of the interstitium, which partly attributable to the absorption of alveolar macrophages and partly due to excess collagen. Compound -related increases in the levels of surfactant were noted in the alveolar macrophages and lumina. In the alveolar macrophages, minimal to slight increases in lamellar surfactant were associated with minimal and moderate increases in amorphous surfactant in animals exposed to 10 mg/m3 pMDI.  In the alveolar lumina, minimal to moderate increase in cell debris were noted in animals exposed to 10 or 4 mg/m3 pMDI. Associated with these increases in cell debris were increases in the amount of crystalline and lamellar surfactant. At 1 mg/m3 there was evidence of effect on surfactant homeostasis, with small increase in number and size of type II cell lamellar bodies and similar increases in  amorphous, crystalline and lamellar surfactant in the  alveolar lumina, which was seen as an adaptive response to exposure to low levels of irritant aerosol. Based on findings of histopathology, bronchiolitis noted at 1 mg/m3 and evidence of effect on surfactant homeostasis at 1 mg/m3, NOAEC could not be defined and the LOAEC was set at 1 mg/m3 pMDI.   In a subchronic inhalation study (SC1) by Reuzel et al. (1994b) (original report Reuzel et al. (1985)) Wistar rats were exposed to pMDI aerosol at concentrations of 0, 0.35, 1.4 and 7.2 mg pMDI/m3, for 6 hours/day, 5 days/week over a period of 13 weeks. Transient slight growth retardation was observed in male rats exposed to 7.2 mg/m3 air. Haematology, blood chemistry and urinalysis did not show treatment-related effects. There were no significant differences in organ weights between the test and control groups. Gross examination at autopsy did not reveal changes which could be ascribed to the test substance. Histopathological examination revealed yellow material (possibly polyurea originated from test material) in the respiratory tract of rats exposed to 7.2 mg/m3. Under the conditions of this test no clear NOAEC was determined. In an associated second subchronic study (SC2) by Reuzel et al. (1994b) (original report by (Reuzel et al., 1986)), Wistar rats were exposed to higher aerosol concentrations of 4.1, 8.4 and 12.3 mg pMDI /m3 air for 3-months. Severe respiratory distress was observed in rats exposed to 12.3 mg/m3 with 11 males and 4 females dying during the exposure period. Significantly less severe signs were seen in rats exposed to 8.4 mg/m3. This study demonstrated adverse effects in the lungs and nasal cavity at levels of 4.1 mg/m3 and above and included histological effects in the lungs (increase in alveolar macrophages and interstitial macrophage infiltration) and in the mediastinal lymph nodes (macrophages with yellowish inclusions). At 8.4 mg/m³ and above increased relative lung weights, partially reversible damage to the olfactory epithelium and basal cell hyperplasia were observed.   In a combined chronic toxicity and carcinogenicity key study (Reuzel et al., 1990; Reuzel et al., 1994a) conducted according to OECD Guideline 453 rats were exposed for 6 hours/day, 5 days/week for one year (satellite groups) or two years (main groups) to aerosol concentrations of 0, 0.2, 1.0 or 6.0 mg pMDI /m3 (analytical concentrations: 0, 0.19, 0.98, 6.03 mg/m3). The effect of chronic exposure of rats to respirable pMDI aerosol was confined to the respiratory tract. The compound-related changes were found in the nasal cavity, the lungs and the mediastinal lymph nodes, and to some degree they were already present after one year of exposure. Histopathology of the organs/tissues investigated showed that exposure to 6.0 mg/m3 over two years was related to the occurrence of pulmonary tumors in males (6 adenomas and 1 adenocarcinoma) and females (2 adenomas). In this two-year rat study, the NOAEC was 0.2 mg/m3 for the repeated dose toxicity of pMDI. The LOAEC was set at 1.0 mg/m3.   The ‘MDI and its reaction products with glycols’ subgroup Pre-liminary results are available for a subacute inhalation study (Ma-Hock, 2021) which was conducted according to OECD 412 on 4,4’-MDI/DPG/HMWP. This study was designed as closely as possible to the study described above by Kilgour et al. (2002) on pMDI to generated comparable data on 2 category boundary substances.  A qualitative and quantitative comparison between these studies will be described in more detail in the category justification document attached to this dossier.   Male and female Wistar rats (7 animals per sex and exposure group) were exposed to 4,4’-MDI/DPG/HMWP liquid aerosol at  concentrations of 0, 1.0, 4.0 and 10 mg/m3 (analytical conc.: 0, 1.0, 3.9 and 9.8 mg/m3), for 6 hours/day, 5 days/week, for  4 weeks (main study). To evaluate the reversibility of effects, 28-day recovery groups were included (recovery control group and 10 mg/m3 exposure group). No mortality was observed throughout the study. During the exposure period clinical signs like respiration sound and piloerection were noted in animals exposed to 10 mg/m3 and one animal exposed to 4 mg/m3. In all other animals, no clinical signs were observed during the exposure period. No clinical signs were observed during the recovery period. Body weights of males exposed to 10 mg/m3 was slightly lower throughout the exposure period but were in the range of the concurrent control at the end of the recovery period. All other groups were comparable throughout exposure and recovery period. A significant increase in mean relative lung weights was observed in males and females of the 10 mg/m3 exposure group, although this had returned to control values at the end of the recovery period. Regarding clinical chemistry, one female of exposure group 4 mg/m3 and 2 females of exposure group 10 mg/m3 (main study) showed an increase in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activities. These effects were regarded as caused by the implant of Alzet osmotic minipumps, thus regarded as treatment related but not substance related effect. All other changes in clinical chemistry observed in exposed animals were regarded as incidental and not treatment related. In animals exposed to 10 mg/m3 a lymphocytic-monocytic inflammation was observed indicated by increased total cell counts as well as absolute and relative lymphocyte and monocyte counts. This type of inflammation was confirmed by marginal, non-relevant increases of lactate dehydrogenase (LDH BAL) and alkaline phosphatase (ALP BAL) activities, but relevantly, slight increases of γ-glutamyl transferase (GGT BAL) activities among these individuals. In BAL of rats exposed to 10 mg/m3 increases of high total protein levels were observed. At the end of the recovery period total protein levels and enzyme activities and cell counts had returned to control levels. Treatment-related histopathological findings were observed in lungs, trachea, larynx, tracheobronchial lymph nodes and mediastinal lymph nodes in male and female animals. Interstitial inflammation of the terminal bronchi was observed in animals exposed to 4 mg/m3 and 10 mg/m3. Hypertrophy/hyperplasia of large, medium and terminal bronchi were observed in animals exposed to 4 mg/m3 and 10 mg/m3, which was associated with an increase in cell proliferation, indicated as a significant increase in BrdU labeling indices. A statistically significantly increased cell proliferation was also observed in animals exposed to 1 mg/m3 in large, medium and terminal bronchi. In alveoli there was a trend towards increased cell proliferation, however there was no dose-response relationship, statistically significance was only seen in males exposed to 10 mg/m3. Pneumocytes type II cells showed minimal proliferation in few animals of the 4 mg/m3 and 10 mg/m3 exposure group. Interstitial inflammation of alveoli was noted in males of the 4 mg/m3 and 10 mg/m3 exposure groups. In the alveolar lumina, neutrophilic infiltration was found occasionally. Debris was seen in one male of the 4 mg/m3 exposure group in alveolar lumina consisting of fragments of cells. Alveolar macrophage accumulation was seen with increased severity in males and females exposed to 10 mg/m3. A minimal increase in alveolar macrophages was still present in females at the end of the recovery period. Macrophages with foamy cytoplasm (foamy macrophages) were observed in males of the 4 mg/m3 and 10 mg/m3 exposure groups and in females exposed to 10 mg/m3. Epithelial alteration in the larynx was noted with increased incidence and severity in treated animals and was characterized by a focal, ventrally located change of the epithelium from cuboidal to focally flattened cells and was noted with increased incidence and severity in treated animals. Lymphocyte infiltration was seen in the submucosa in treated animals. The trachea epithelium on the tip of the carina was changed from its normal cuboidal, ciliated appearance to a single layer of flattened cells with loss of cilia in treated animals. Hyperplasia of the trachea epithelium was seen in males exposed to 4 mg/m3 and 10 mg/m3 and females exposed to 10 mg/m3. Beneath the epithelium, there was an increased infiltration of lymphocytes in single animals. A diffuse enlargement of mediastinal and tracheobronchial lymph nodes was seen in treated animals. The histopathological changes noted after termination of exposure were mostly reversible. An increased incidence of minimal alveolar macrophage accumulation was still observed at the end of the recovery period in treated females. Increased cell proliferation in alveoli was still observed in treated males. No other treatment related findings were observed at the end of the recovery period.   In summary, substance-related systemic effect was not observed. Under the current study conditions, the no observed adverse effect level (NOAEL) for systemic toxicity was 10 mg/m³. The NOAEL for local toxicity could not be established due to the slight changes in labeling indices present at 1 mg/m³ (Ma-Hock, 2021).   Human information A large dataset is available in human epidemiological and case studies for chronic exposure to diisocyanates in the workplace and reported effects are limited to respiratory system. Effects associated with respiratory sensitization are described in chapter sensitization and potential carcinogenicity is described in carcinogenicity chapter. In general, long term exposure to MDI substances can result in non-immunological decreases in lung function and other respiratory symptoms associated with chronic irritation. Interpretation of many of these studies is confounded by simultaneous exposure to TDI and inaccurate exposure data. Despite these limitations, pMDI concentrations as low as 87 ppb (0.9 mg/m3) were shown to correlate with deterioration in lung function whereas when exposures were below a maximum concentration of 20 ppb (0.2 mg/m3), no significant changes in lung spirometry was generally observed (DFG, 2008). The frequency of respiratory complaints was not significantly increased when exposure levels were below 10 ppb (0.1 mg/m3) (DFG, 2008).     Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint: No system toxicity up to the highest dose group tested   Inhalation is the most appropriate route of exposure for assessing occupational risk of substances of the MDI category in humans. Repeated dose studies are available for the three boundary substances , GLP compliant study on both 4,4’-MDI and pMDI with reliability 2, conducted according to OECD Guideline 453 (combined chronic toxicity/carcinogenicity studies) and two 28 day studies on pMDI and 4,4’-MDI/DEG/HMWP. In all repeated dose studies, toxic effects were limited to the site of contact with no systemic effects observed distant from the portal of entry, which is in line with the discussed MoA of MDI toxicity (see category justification document).   Repeated dose toxicity: inhalation - local effects (target organ) respiratory: respiratory tract   ​ Inhalation is the most appropriate route of exposure for assessing occupational risk of substances of the MDI category in humans. Repeated dose studies are available for the three boundary substances, GLP compliant study on both 4,4’-MDI and pMDI with reliability 2, conducted according to OECD Guideline 453 (combined chronic toxicity/carcinogenicity studies) and two 28 day studies on pMDI and 4,4’-MDI/DEG/HMWP. Consistent with the hypothesized MoA proposed (see category justification document) for these substances the primary health effect following inhalation exposure is local irritation within the respiratory tract without significant systemic exposure or toxicity. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de22b6e1-2b3e-4195-a4dd-2c1418f0cc1e/documents/3c2aa6cb-5926-4781-bf26-ff77265a67f0_9e4ae0e4-8bc5-46a9-9920-0ef7263b73db.html,,,,,, "4,4'-Methylenediphenyl diisocyanate, oligomeric reaction products with 2,4'-diisocyanatodiphenylmethane",109331-54-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de22b6e1-2b3e-4195-a4dd-2c1418f0cc1e/documents/3c2aa6cb-5926-4781-bf26-ff77265a67f0_9e4ae0e4-8bc5-46a9-9920-0ef7263b73db.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1 mg/m3,adverse effect observed, "4,4'-Methylenediphenyl diisocyanate, oligomeric reaction products with 2,4'-diisocyanatodiphenylmethane",109331-54-6,"Data gap filling for the acute inhalation toxicity endpoint is achieved using the category approach according to ECHA guidance on read-across (ECHA, 2017c). For this endpoint, all effects are consistent with the hypothesized MoA and direct electrophilic reactions of NCO with biological nucleophiles. Modified MDI substances contain different higher molecular weight constituents, and all have in common a high content of bioaccessible low molecular weight MDI constituents responsible for presenting NCO reactivity, scenario 4 or 6 according to the RAAF considered as most appropriate due to a common mechanism. Selection between scenario 4 and 6 depends essentially upon the presence of variation in the properties i.e. magnitude of effect. Since it has been demonstrated that the bioaccessible low molecular weight MDI constituents are responsible for presenting NCO reactivity, and the higher molecular weight MDI constituents do not contribute to the observed toxicity it is reasonable to assume that their presence in these mixtures attenuates toxicity. Further, as a worst-case approach is adopted in which 4,4’-MDI isomer is used for read-across to all substances of the MDI category, then use of RAAF Scenario 4 (variations in the properties observed among source substances) is justified over scenario 6.   Acute oral toxicity In the case of oral exposure, before the reactive NCO groups present on the substances of the MDI category have opportunity to react locally, or be absorbed, they polymerize in the acid environment of the stomach to form solid polyureas that are excreted via the feces without being absorbed. Consequently, if exposure were to occur by the oral route this would not lead to local or systemic effects. For MDI Mixed Isomers, the key study (Reliability 1) did not record mortality up to the limit dose of 2,000 mg/kg bw . A supporting study describing the acute oral toxicity of pMDI conducted similar to OECD 401 guideline (Reliability 2) also did not find any mortality up to the maximum dose tested, hence the LD50 is greater than 10,000 mg/kg bw . Other studies on MDI substances are consistent with this, albeit with lower reliability.  Four additional acute oral toxicity studies (Reliability 1) have been conducted on other representative substances of the category subgroups (i.e. ‘MDI, its condensation products and the reaction products with glycols’ and ‘MDI and its reaction products with glycols’). In all cases, there was no mortality up to the limit dose (5,000 mg/kg). The lack of mortality in the available acute oral toxicity across the available studies, alongside the lack of gross lesions in distal tissues (e.g. liver, kidney etc.) supports the lack of systemic bioavailability. The NCO groups present on MDI substances react with acids within the stomach leading to formation of an insoluble polymerized mass that is excreted in the feces without being absorbed (see Toxicokinetics).  Supporting evidence comes in the form of several accidental ingestion reports in dogs where ingestion of MDI based glues produced no intrinsic toxic effects other than the formation of a solid polyurea mass that may lead to gastric obstruction. When the mass was removed by surgery, rapid and complete recovery was achieved (Horstman et al., 2003; Ohngren, 2007).     Acute dermal toxicity In the case of dermal exposure, before the reactive NCO groups present on MDI substances have opportunity to be absorbed to any significant extent through the stratum corneum they react with proteins and moisture at the skin surface leading to the formation of an insoluble polymerized mass thereby limiting dermal absorption and systemic availability (Leibold 1999). Modified MDI substances, having a higher molecular weight than mMDI isomers and due to their higher molecular volume, increased octanol-water partition coefficient and decreased water solubility will in any event not be able to penetrate the stratum corneum (Bartels 2021). The available acute dermal toxicity studies indicate that all substances of the MDI category have low acute dermal toxicity. The key study describing the acute dermal toxicity of pMDI in rabbits did not find lethality up to the maximum dose tested, and the LD50 was greater than 9,400 mg/kg bw (Wazeter et al., 1964a). Other less reliable studies on pMDI or 4,4’-MDI are consistent with this.  Observed differences in LD50 values between pMDI and 4,4'-MDI/TPG are not considered to be significant or represent a trend since they are significantly higher than the limit for classification and are indicative of a lack of systemic exposure. The available data for the substances of the MDI category is consistent with the hypothesis that NCO groups present on MDI substances react with proteins and moisture at the skin surface leading to the formation of an insoluble polymerized mass resulting in limited dermal absorption and systemic availability. The available data and hypothesis is supported by the key dermal absorption study that shows that MDI substances have very low systemic bioavailability (<1 %) (Leibold et al., 1999). By comparison, modified MDI substances, with molecular weight greater than mMDI, will demonstrate even further reduced dermal absorption based upon physico-chemical properties (i.e. increased octanol-water partition coefficient, decreased water solubility, and increased molecular weight), and this has been confirmed with GastroPlus™ modeling (Bartels, 2021). Although a reliable, acute dermal in vivo toxicity data is only available on two category substances, it is considered sufficient for assessment of this endpoint for the category. Due to the low predicted dermal bioavailability of all category substances, and the lack of systemic toxicity demonstrated in the oral acute toxicity studies, additional testing is not justified as all substances of the MDI category would be predicted to have comparable or reduced acute dermal toxicity potential to tested substances.   Acute Inhalation Toxicity Following inhalation exposure the initiating event in hypothesised MoA for acute toxicity in the lung is the reaction of the MDI substance with GSH in the airway lining fluid (adduct formation). Subsequent development of toxic effects is driven by the rate of depletion of GSH. This depletion begins with the reduction in extracellular GSH, which leads to a reduction in intracellular GSH disturbing the redox balance in the cell. With increasing amounts of NCO exposure (e.g. via exposure concentration or bioaccessibility), the protective GSH system gradually becomes overwhelmed, and toxicity evolves along the path: (1) no cytotoxicity; (2) cytotoxic effects; (3) reduced cell viability; and (4) cell death. This is accompanied by increasing extravasation because of increased junction permeability and epithelial damage ultimately causing edema.    The rate of nucleophile depletion by MDI-based substances is driven by the availability of the NCO-group, which itself is a function of (1) the NCO value of the substance and (2) the molecular weight of its constituents (driving its reactive dissolution). Monomeric MDI isomers have been shown to become available at a similar rate in toxicokinetic studies (Wisnewski, 2018; Wisnewski et al., 2019a) which is consistent with the generally comparable LC50 values for all of the isomers. Conversely, higher molecular weight constituents have both a reduced NCO value and exhibit reduced water solubility, making them less accessible to react with GSH. Therefore, the substances with the highest available NCO value and bioaccessibility (mMDI and three-ring oligomers) are the most toxic, while those with increasing amounts constituents less able to react with GHS demonstrate reduced toxicity.   Tests also show that toxicity is limited to portal-of-entry effects. The absence of systemic toxicity is due to the extracellular reactions described above, combined with transcarbamoylation to proteins described in more detail in the Chapter (Toxicokinetics), constitute a detoxification mechanism. Acute toxicity is only observed when this protective mechanism becomes overwhelmed and is limited to the lung. This mode of action is supported with high confidence by reliable acute inhalation data available for multiple MDI isomers and modified MDI substances (described in more detail below). The toxicity of MDI substances will decrease with increasing average molecular weight as these substances will have constituents that are less bioaccessible and with a lower NCO value. For these substances, higher exposure concentration is required to induce toxic effects, which is consistent with the observed results from the available acute inhalation toxicity tests.  Testing proposal: While testing is available on 8 MDI category memeber (including all sub-groups) acute toxicity testing (OECD 403) will be performed on an additional 4 MDI substances.  This information will further support the category hypothesis as well as help to define substance selection and study design for repeat-dose bridging studies.    Available data: The ‘Monomeric MDI’ subgroup Reliable acute inhalation studies are available for all three isomers of mMDI (2,2’-; 2,4’-; and 4,4’-MDI) in accordance with OECD Guideline 403 in a series of studies by (Pauluhn, 2008d; Pauluhn, 2008e; Pauluhn, 2008f). All three substances consist of more than 98 % pure mMDI, corresponding to NCO value of 33%. In all cases, mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA. LC50s were comparable and ranged from 368 to 598 mg/m3 for males and from 559 to 686 mg/m3 for females. For all studies, exposure parameters met internationally recognized recommendations for MMAD and GSD and were similar for all three isomers. The ‘Oligomeric MDI’ subgroup Polymeric MDI (approximately 40 % mMDI; 33 % NCO value, with viscosity of approximately 200 mPas) was tested in an acute inhalation toxicity study according to OECD 403 (Pauluhn, 2008c). Mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA. An LC50 (95 % confidence interval) of 310.2 (266.4-361.3) mg/m3 was determined for pMDI.  Polymeric MDI was also tested following depletion of monomeric MDI resulting in a mixture of 1.2 % mMDI and 98.8 % of higher (> two-ring) oligomers according to OECD 403 (Pauluhn, 2011a). The combined LC50, for male and female rats, for ‘monomer-depleted pMDI’ was greater than 2,188 mg/m3. Average mean mass aerodynamic diameter (MMAD) and geometric standard deviation (GSD) was generally comparable to that of the pMDI containing mMDI (85-87 %). The ‘MDI and its condensation products’ subgroup The acute inhalation toxicity of MDI Mixed isomers/PIR (60 % mMDI and NCO value of 26 %) was tested in an acute inhalation toxicity study according to OECD 403 (Pauluhn, 2012). The combined LC50 for male and female rats was 1,088 mg/m3, mortality was linked to portal of entry effects of the respiratory system, including severe irritation and pulmonary edema. Mortality occurred up to two days post-exposure and was causally related to an acute pulmonary edema. The ‘MDI and its reaction products with glycols’ subgroup Two reliable acute inhalation studies are available for substances of the ‘MDI and its reaction products with glycols’ subgroup. The acute inhalation toxicity of 4,4'-MDI/1,3-BD/TPG/PG (60 % mMDI; 23 % NCO) was conducted according with OECD 403 (Kopf, 2016).  The LC50 was calculated to be 518 mg/m3, and mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA.  The acute inhalation study of 4,4'-MDI/DPG/HMWP (50 % mMDI; 25 % NCO) was tested according to OECD 403 (Hotchkiss and Weidemoyer, 2020). The LC50 is 1,110 mg/m3 for male rats and 1,250 mg/m3 for female rats. The four-hour LC50 is 1.15 mg/L for male and female rats combined. Similar to the other LC50 studies, mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA.   An acute inhalation study was performed in rats at only one concentration level of 2.24 mg/L/1h (Pauluhn 2003, 2004). This study was specifically designed to comply with NFPA 704, and also complied with the limit test of the OECD guideline 403 with deviations (only 1 hr exposure, concentration lower than limit test concentration) and is therefore reliable with restrictions. Exposure of 4,4’-MDI for 1 hr resulted in mortality shortly after exposure of one out of ten rats. Clinical signs were characterised by typical signs of respiratory tract irritation. Necropsy findings were unremarkable in surviving rats, whilst the rat that succumbed displayed signs of lung oedema which was considered to be the cause of death. The LC50 >2.24 mg/L/1h (analytical) in both males and females was determined.        Adequacy of the available data for risk assessment and classification purposes Using the strict GHS LC50 cut-off for classification, the LC50 values obtained for the mMDI would trigger a Category 2 (or Category 3) according to GHS CLP. However, classification for these substances according to ECHA CLP Guidance (2017) text allows for the application of scientific judgement. It must be considered that the LC50 cut-off of 500 mg/m3 (approximately 50 ppm for pMDI), is over 2,500-fold above the saturated vapor concentration for pMDI. This difference is even further exacerbated in the pre-polymer mixtures where the presence of the higher molecular weight fraction even further reduces the vapor pressure making exposure less likely.    Furthermore, the aerosols were generated using sophisticated techniques in the laboratory, whereby extremely small particles are generated in order to meet international guidelines for testing. This size and concentration of aerosol is not generated in the workplace even under foreseeable worst-case conditions (Ehnes et al., 2019). The particle size distribution of aerosols formed during actual spraying applications has virtually no overlap with that of the highly respirable aerosol generated in inhalation studies (see EC (2005)). Due to a very low vapor pressure (<0.01 Pa) MDI substances are not inherently toxic by inhalation since the saturated vapor concentration would be orders of magnitude below toxic concentration. It is only with modification and input (in terms of heat, cooling and size screening) that MDI substances become toxic after inhalation. In the EU risk assessment report (EU 2005) MDI is classified as  harmful by inhalation.   The acute inhalation data of pMDI and 4,4’-MDI data were considered by EU experts, and their conclusion that MDI be classified as “Harmful” and  reported in the 25th Adaptation to Technical Progress (ATP) to the Dangerous Substances Directive (67/548/EEC). This was endorsed in the 28th ATP and both MDI substances remain as “Harmful” in the 30th ATP (adopted by Member States on 16 February 2007 and published 15th September 2008). The original decision was upheld in the EU Risk Assessment of MDI (Directive 793/93/EEC, 3rd Priority List) published in 2005, noting that considering “the exposure assessment, it is reasonable to consider MDI as harmful only and to apply the risk management phrase ‘harmful by inhalation’. This classification was also endorsed by the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE, now SCHER) in giving their opinion on the Risk Assessment (EC, 2008). With the enforcement of the CLP regulation (Regulation (EC) No 1272/2008) in 2009, the Dangerous Substance/Preparation Directive (DSD) was repealed and harmonized classifications were formally transferred to the CLP regulation; MDI is classified with Acute Tox. 4 H332 (Annex VI Regulation (EC) No 1272/2008 (CLP regu lation). Given the mechanism of action of the MDI substances and the changes in physical chemical properties imparted by the modifications in the modified MDI substances, the entire category is consistent with this guidance and classification, and the classification should not be changed.   The classification as “Harmful”, is equivalent to GHS Category 4. For these reasons, the GHS proposal follows the EU Regulatory lead accepting that the animal data are inappropriate and classified pMDI as GHS acute toxicity category 4 (ISOPA 2007).    Conclusion    Assessment of the available acute toxicity data indicates that inhalation exposure to the aerosols of MDI results in toxicity confined predominantly to the respiratory tract. In terms of hazard characterization, MDI is harmful by inhalation according to EU (H332) and GHS (Cat. 4) classification. MDI is non-toxic after single oral and dermal exposure.     Justification for classification or non classification:    EU classification according to CLP: H332     GHS classification (GHS UN rev.2, 2007): Inhalation route (vapour): Acute Category 4.     Not toxic by the dermal or oral routes. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Results are consistent within the key study Bomhard (1990) (reliability1)and data from a supporting study (Wazeter et al. 1964) (reliability 2). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de22b6e1-2b3e-4195-a4dd-2c1418f0cc1e/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_9e4ae0e4-8bc5-46a9-9920-0ef7263b73db.html,,,,,, "4,4'-Methylenediphenyl diisocyanate, oligomeric reaction products with 2,4'-diisocyanatodiphenylmethane",109331-54-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de22b6e1-2b3e-4195-a4dd-2c1418f0cc1e/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_9e4ae0e4-8bc5-46a9-9920-0ef7263b73db.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4,4'-Methylenediphenyl diisocyanate, oligomeric reaction products with 2,4'-diisocyanatodiphenylmethane",109331-54-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de22b6e1-2b3e-4195-a4dd-2c1418f0cc1e/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_9e4ae0e4-8bc5-46a9-9920-0ef7263b73db.html,,inhalation,LC50,431 mg/m3,adverse effect observed, "4,4'-Methylenediphenyl diisocyanate, oligomers",25686-28-6,"Description of Key information The test substance is part of a category approach of methylenediphenyl diisocyanates (MDI) with existing data gaps filled according to ECHA guidance on Read Across (ECHA, 2017).  The read-across category justification document is attached in IUCLID section 13 and summarized below in Additional Informaiton.  Data-gaps in this endpoint is satisfied by weight of evidence and read across from valid repeated dose toxicity studies for the inhalation route. Reliable repeated dose inhalation data in animals is available for the boundary substances (4,4’-MDI, pMDI and 4,4’-MDI/DPG/HMWP). The chronic repeated dose toxicity study (Reuzel et al. 1994, reliability 2) performed with pMDI is a guideline study (OECD 451). In addition, valid sub-chronic and sub-acute repeated dose toxicity studies are available  for pMDI (Reuzel et al. 1994, Kilgour et al. 2002, reliability 2). For the 4,4’-MDI a valid chronic inhalation toxicity study is available (Hoymann et al. 1995, reliability 2) and a limited documented sub-chronic inhalation toxicity study (Heinrich et al. 1991, reliability 4). For the boundary substance 4,4’-MDI/DPG/HMWP a sub-acute toxicity study is available (Ma-Hock, 2021, reliability 1).   Proposed Testing: To support this weight of evidence and read across approach additional repeated dose toxicity testing is planned. It is considered to perform a sub-chronic inhalation toxicity study (OECD 413) with boundary substance 4,4’-MDI/DPG/HMWP. Additional, combined Repeated Dose Toxicity studies with Reproductive/ developmental Toxicity Screening tests (OECD 422) will be performed on 9 substances representing all sub-groups and key structural/chemical characteristics (see overview attached in Annex 27 in Chapter 13). These screening studies will confirm the proposed MoA on repeated dose toxicity or identify substances that may require additional testing.   Available information: Several sub-acute, sub-chronic and chronic studies have been performed on 4,4’-MDI, pMDI and 4,4’-MDI/DPG/HMWP and are described in Category justification document in Chapter 13 . A repeated dose dermal toxicity study was performed in rabbits with pMDI (Wazeter et al., 1964a) but since this only has fourteen days of treatment and only slight local skin irritants effects were observed this is omitted from this chapter, but rather described in chapter addressing skin irritation. As with the acute studies, in all repeated dose studies, toxic effects were limited to the site of contact with no systemic effects observed distant from the portal of entry. Key repeated dose studies days are described below:  The ‘Monomeric MDI’ subgroup In a subchronic inhalation study with 4,4’-MDI, female Wistar rats were exposed to concentrations of MDI of 0, 0.3, 1 or 3 mg 4,4’-MDI/m3 for 18 hours a day on 5 days a week for 13-weeks. Reduced body weight gains and an increase in relative lung weights were found at 1 mg/m3 and above. At and above this concentration infiltration of mononuclear cells, goblet cell hyperplasia, erosion of the respiratory epithelium in the upper respiratory tract, hyperplasia of the bronchus-associated lymphatic tissue and inflammatory changes of the lung were additionally observed. At 3 mg/m3 there was an increase in the total cell count and proportion of granulocytes and lymphocytes, a decrease in the proportion of macrophages in the bronchoalveolar lavage fluid, an increase in protein, β-glucuronides and lactate dehydrogenase, and changes in lung function. No effects were observed at 0.3 mg/m3 (Heinrich et al., 1991). A subsequent chronic inhalation study (Hoymann et al., 1995) was conducted with 4,4’-MDI. Female Wistar rats were exposed to 0.23, 0.70 or 2.05 mg 4,4’-MDI/m³ aerosols for 17 hours/day, 5 days /week for up to 24 months. Essentially, a dose-dependent impairment of the lung function in terms of an obstructive-restrictive malfunction with diffusion disorder, increased lung weights, an inflammatory reaction with increased appearance of lymphocytes in the lung in the high dose group as a sign of specific stimulation of the immune system by MDI, an intermediately retarded lung clearance in the high dose group as well as dose-dependent interstitial and peribronchiolar fibrosis, alveolar bronchiolisations and a proliferation of the alveolar epithelium, which was classified as preneoplastic, as well as a bronchiolo-alveolar adenoma were identified. The LOAEC for the female rat was identified as 0.23 mg/m3 based on minor histopathological pulmonary lesions after long-term inhalation of 4,4'-MDI aerosols.  A comparison of the pulmonary effects described in female rats from the two chronic studies, one with 4,4’-MDI and the other with pMDI, was published by Feron et al. (2001). To assist the comparison and account for the lower proportion of mMDI in pMDI, the authors normalized the different MDI doses to total inhalation exposures calculated as 559; 1,972; 2,881; 6,001; 17,575 and 17,728 mg mMDI.h/m3. The major pulmonary effects in the two studies were characterized by hyperplasia, interstitial fibrosis and a low incidence of bronchiolo-alveolar adenoma, the latter occurring in the high exposure groups of both studies (i.e. total inhalation exposures of 17,728 and 17,575 mg.h/m3). Both studies also reported the presence of particle-laden macrophages predominantly in the alveoli close to the alveolar ducts which in some cases, particularly in high dose groups, were associated with areas of fibrosis. There was a clear quantitative dose response in both studies with the lowest dose of 559 mg mMDI.h/m3 from the study reported by Reuzel et al. (1994a) being described as the no-observed-adverse-effect-level (NOAEL) Feron et al. (2001) also suggested that the mild histopathological changes seen in the low exposure animals (0.23 mg/m3) in the Hoymann et al. (1995) study, would not have occurred if the exposure had been for six hours/day. An exposure of 0.2 mg/m3 over a six-hour period was judged to be the NOAEL in both studies. Overall, the analysis concluded that both studies showed similar qualitative responses to exposures to pMDI or 4,4’-MDI when compared on the basis of mMDI content..  The ‘Oligomeric MDI’ subgroup In a subacute inhalation study by Kilgour et al. (2002), female Alpk:APfSD rats were exposed to pMDI aerosol at  concentrations of 0, 1.0, 4.0 and 10 mg pMDI/m3, for 6 hours/day, 5 days/week, for  28 days, a 30-day recovery group was included. No clinical signs were noted during exposure and recovery phase. Body weights in all groups were comparable to controls throughout exposure and recovery periods. Lung weights were increased in animals exposed to 10 mg/m3 at the end of the exposure period, although this had returned to control values by day 30 post-exposure. Lung weights of all other treated groups were in the range of the control group. A dose-dependent influx of inflammatory cells, total protein levels and increase in enzyme activities indicated an inflammatory reaction. A statistically significant increase in both the total number of cells counted and alveolar macrophages in lavage fluid was noted at 10 mg/m3, and a slight (but not statistically significant) following exposure to 4 mg/m3. The polymorphonulear leukocytes (PMNs) and lymphocyte/other cells showed statistically significant, concentration-related increases in cell counts following exposure to 4 or 10 mg/m3 pMDI. At the end of the recovery phase, cell counts in exposed animals had returned to normal. Animals of the exposure groups 4 and 10 mg/m3 showed an increase of macrophages containing vacuoles (foamy macrophages), whereas the 1 mg/m3 group was in the range of the control animals. At the end of the recovery period few macrophages vacuoles were still discernable. In animal exposed to 10 mg/m3 pMDI a statistically significant increase in total protein and alkaline phosphatase activity was noted in lavage fluid at the end of exposure, whereas lactate dehydrogenase and N-acetyl glucosaminidase (NAG) activities were not increased. All other treated groups in the main study and all groups at the end of the recovery phase showed values similar to controls. A transient increase in phospholipids concentration was noted in the lavage fluid from animals exposed to 10 mg/m3 pMDI after exposure, no differences from control values were seen at the end of the recovery phase. In all exposure groups a statistically significant concentration-related increase in BrdU labelling index in terminal bronchioles were seen; a similar increase in centro-acinar alveoli were found in animals exposed to 4 and 10 mg/m3 pMDI. At the end of the recovery phase, labelling indices were similar to control values at all concentrations. No macroscopic abnormalities were noted. Histopathology of the lung showed in animals exposed to 10 mg/m3 pMDI an increase in bronchiolitis and thickening of the centro-acinar region, interstitial thickening at the acinar junctions, and accumulations of alveolar macrophages containing yellow pigment in the cytoplasm. In animals exposed to 4 mg/m3 pMDI 1/5 animals showed thickening of the centro-acinar region and bronchiolitis and 1/5 animals exposed to 1 mg/m3 pMDI showed bronchiolitis. After the recovery phase, alveolar macrophages containing a yellow pigment were present in the interstitium in all animals that had been exposed to 10 mg//m3 pMDI but were absent in animals exposed to 1 or 4 mg/m3 pMDI. In addition, 1/5 animals exposed to 10 mg/m3 pMDI still had bronchiolitis and centro-acinar thickening, but at a reduced severity and distribution to that seen in the main study. Ultrastructural findings suggest a perturbation of surfactant homeostasis by exposure to pMDI which is supported by the small increase in measured phospholipids and observation of foamy macrophages. Animals exposed to 10 mg/m3 pMDI showed a slight thickening of the interstitial alveolar wall in 3/5 animals. The thickening in the centro-acinar region was due to thickening of the interstitium, which partly attributable to the absorption of alveolar macrophages and partly due to excess collagen. Compound -related increases in the levels of surfactant were noted in the alveolar macrophages and lumina. In the alveolar macrophages, minimal to slight increases in lamellar surfactant were associated with minimal and moderate increases in amorphous surfactant in animals exposed to 10 mg/m3 pMDI.  In the alveolar lumina, minimal to moderate increase in cell debris were noted in animals exposed to 10 or 4 mg/m3 pMDI. Associated with these increases in cell debris were increases in the amount of crystalline and lamellar surfactant. At 1 mg/m3 there was evidence of effect on surfactant homeostasis, with small increase in number and size of type II cell lamellar bodies and similar increases in  amorphous, crystalline and lamellar surfactant in the  alveolar lumina, which was seen as an adaptive response to exposure to low levels of irritant aerosol. Based on findings of histopathology, bronchiolitis noted at 1 mg/m3 and evidence of effect on surfactant homeostasis at 1 mg/m3, NOAEC could not be defined and the LOAEC was set at 1 mg/m3 pMDI.   In a subchronic inhalation study (SC1) by Reuzel et al. (1994b) (original report Reuzel et al. (1985)) Wistar rats were exposed to pMDI aerosol at concentrations of 0, 0.35, 1.4 and 7.2 mg pMDI/m3, for 6 hours/day, 5 days/week over a period of 13 weeks. Transient slight growth retardation was observed in male rats exposed to 7.2 mg/m3 air. Haematology, blood chemistry and urinalysis did not show treatment-related effects. There were no significant differences in organ weights between the test and control groups. Gross examination at autopsy did not reveal changes which could be ascribed to the test substance. Histopathological examination revealed yellow material (possibly polyurea originated from test material) in the respiratory tract of rats exposed to 7.2 mg/m3. Under the conditions of this test no clear NOAEC was determined. In an associated second subchronic study (SC2) by Reuzel et al. (1994b) (original report by (Reuzel et al., 1986)), Wistar rats were exposed to higher aerosol concentrations of 4.1, 8.4 and 12.3 mg pMDI /m3 air for 3-months. Severe respiratory distress was observed in rats exposed to 12.3 mg/m3 with 11 males and 4 females dying during the exposure period. Significantly less severe signs were seen in rats exposed to 8.4 mg/m3. This study demonstrated adverse effects in the lungs and nasal cavity at levels of 4.1 mg/m3 and above and included histological effects in the lungs (increase in alveolar macrophages and interstitial macrophage infiltration) and in the mediastinal lymph nodes (macrophages with yellowish inclusions). At 8.4 mg/m³ and above increased relative lung weights, partially reversible damage to the olfactory epithelium and basal cell hyperplasia were observed.   In a combined chronic toxicity and carcinogenicity key study (Reuzel et al., 1990; Reuzel et al., 1994a) conducted according to OECD Guideline 453 rats were exposed for 6 hours/day, 5 days/week for one year (satellite groups) or two years (main groups) to aerosol concentrations of 0, 0.2, 1.0 or 6.0 mg pMDI /m3 (analytical concentrations: 0, 0.19, 0.98, 6.03 mg/m3). The effect of chronic exposure of rats to respirable pMDI aerosol was confined to the respiratory tract. The compound-related changes were found in the nasal cavity, the lungs and the mediastinal lymph nodes, and to some degree they were already present after one year of exposure. Histopathology of the organs/tissues investigated showed that exposure to 6.0 mg/m3 over two years was related to the occurrence of pulmonary tumors in males (6 adenomas and 1 adenocarcinoma) and females (2 adenomas). In this two-year rat study, the NOAEC was 0.2 mg/m3 for the repeated dose toxicity of pMDI. The LOAEC was set at 1.0 mg/m3.   The ‘MDI and its reaction products with glycols’ subgroup Pre-liminary results are available for a subacute inhalation study (Ma-Hock, 2021) which was conducted according to OECD 412 on 4,4’-MDI/DPG/HMWP. This study was designed as closely as possible to the study described above by Kilgour et al. (2002) on pMDI to generated comparable data on 2 category boundary substances.  A qualitative and quantitative comparison between these studies will be described in more detail in the category justification document attached to this dossier.   Male and female Wistar rats (7 animals per sex and exposure group) were exposed to 4,4’-MDI/DPG/HMWP liquid aerosol at  concentrations of 0, 1.0, 4.0 and 10 mg/m3 (analytical conc.: 0, 1.0, 3.9 and 9.8 mg/m3), for 6 hours/day, 5 days/week, for  4 weeks (main study). To evaluate the reversibility of effects, 28-day recovery groups were included (recovery control group and 10 mg/m3 exposure group). No mortality was observed throughout the study. During the exposure period clinical signs like respiration sound and piloerection were noted in animals exposed to 10 mg/m3 and one animal exposed to 4 mg/m3. In all other animals, no clinical signs were observed during the exposure period. No clinical signs were observed during the recovery period. Body weights of males exposed to 10 mg/m3 was slightly lower throughout the exposure period but were in the range of the concurrent control at the end of the recovery period. All other groups were comparable throughout exposure and recovery period. A significant increase in mean relative lung weights was observed in males and females of the 10 mg/m3 exposure group, although this had returned to control values at the end of the recovery period. Regarding clinical chemistry, one female of exposure group 4 mg/m3 and 2 females of exposure group 10 mg/m3 (main study) showed an increase in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activities. These effects were regarded as caused by the implant of Alzet osmotic minipumps, thus regarded as treatment related but not substance related effect. All other changes in clinical chemistry observed in exposed animals were regarded as incidental and not treatment related. In animals exposed to 10 mg/m3 a lymphocytic-monocytic inflammation was observed indicated by increased total cell counts as well as absolute and relative lymphocyte and monocyte counts. This type of inflammation was confirmed by marginal, non-relevant increases of lactate dehydrogenase (LDH BAL) and alkaline phosphatase (ALP BAL) activities, but relevantly, slight increases of γ-glutamyl transferase (GGT BAL) activities among these individuals. In BAL of rats exposed to 10 mg/m3 increases of high total protein levels were observed. At the end of the recovery period total protein levels and enzyme activities and cell counts had returned to control levels. Treatment-related histopathological findings were observed in lungs, trachea, larynx, tracheobronchial lymph nodes and mediastinal lymph nodes in male and female animals. Interstitial inflammation of the terminal bronchi was observed in animals exposed to 4 mg/m3 and 10 mg/m3. Hypertrophy/hyperplasia of large, medium and terminal bronchi were observed in animals exposed to 4 mg/m3 and 10 mg/m3, which was associated with an increase in cell proliferation, indicated as a significant increase in BrdU labeling indices. A statistically significantly increased cell proliferation was also observed in animals exposed to 1 mg/m3 in large, medium and terminal bronchi. In alveoli there was a trend towards increased cell proliferation, however there was no dose-response relationship, statistically significance was only seen in males exposed to 10 mg/m3. Pneumocytes type II cells showed minimal proliferation in few animals of the 4 mg/m3 and 10 mg/m3 exposure group. Interstitial inflammation of alveoli was noted in males of the 4 mg/m3 and 10 mg/m3 exposure groups. In the alveolar lumina, neutrophilic infiltration was found occasionally. Debris was seen in one male of the 4 mg/m3 exposure group in alveolar lumina consisting of fragments of cells. Alveolar macrophage accumulation was seen with increased severity in males and females exposed to 10 mg/m3. A minimal increase in alveolar macrophages was still present in females at the end of the recovery period. Macrophages with foamy cytoplasm (foamy macrophages) were observed in males of the 4 mg/m3 and 10 mg/m3 exposure groups and in females exposed to 10 mg/m3. Epithelial alteration in the larynx was noted with increased incidence and severity in treated animals and was characterized by a focal, ventrally located change of the epithelium from cuboidal to focally flattened cells and was noted with increased incidence and severity in treated animals. Lymphocyte infiltration was seen in the submucosa in treated animals. The trachea epithelium on the tip of the carina was changed from its normal cuboidal, ciliated appearance to a single layer of flattened cells with loss of cilia in treated animals. Hyperplasia of the trachea epithelium was seen in males exposed to 4 mg/m3 and 10 mg/m3 and females exposed to 10 mg/m3. Beneath the epithelium, there was an increased infiltration of lymphocytes in single animals. A diffuse enlargement of mediastinal and tracheobronchial lymph nodes was seen in treated animals. The histopathological changes noted after termination of exposure were mostly reversible. An increased incidence of minimal alveolar macrophage accumulation was still observed at the end of the recovery period in treated females. Increased cell proliferation in alveoli was still observed in treated males. No other treatment related findings were observed at the end of the recovery period.   In summary, substance-related systemic effect was not observed. Under the current study conditions, the no observed adverse effect level (NOAEL) for systemic toxicity was 10 mg/m³. The NOAEL for local toxicity could not be established due to the slight changes in labeling indices present at 1 mg/m³ (Ma-Hock, 2021).   Human information A large dataset is available in human epidemiological and case studies for chronic exposure to diisocyanates in the workplace and reported effects are limited to respiratory system. Effects associated with respiratory sensitization are described in chapter sensitization and potential carcinogenicity is described in carcinogenicity chapter. In general, long term exposure to MDI substances can result in non-immunological decreases in lung function and other respiratory symptoms associated with chronic irritation. Interpretation of many of these studies is confounded by simultaneous exposure to TDI and inaccurate exposure data. Despite these limitations, pMDI concentrations as low as 87 ppb (0.9 mg/m3) were shown to correlate with deterioration in lung function whereas when exposures were below a maximum concentration of 20 ppb (0.2 mg/m3), no significant changes in lung spirometry was generally observed (DFG, 2008). The frequency of respiratory complaints was not significantly increased when exposure levels were below 10 ppb (0.1 mg/m3) (DFG, 2008).     Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint: No system toxicity up to the highest dose group tested   Inhalation is the most appropriate route of exposure for assessing occupational risk of substances of the MDI category in humans. Repeated dose studies are available for the three boundary substances , GLP compliant study on both 4,4’-MDI and pMDI with reliability 2, conducted according to OECD Guideline 453 (combined chronic toxicity/carcinogenicity studies) and two 28 day studies on pMDI and 4,4’-MDI/DEG/HMWP. In all repeated dose studies, toxic effects were limited to the site of contact with no systemic effects observed distant from the portal of entry, which is in line with the discussed MoA of MDI toxicity (see category justification document).   Repeated dose toxicity: inhalation - local effects (target organ) respiratory: respiratory tract   ​ Inhalation is the most appropriate route of exposure for assessing occupational risk of substances of the MDI category in humans. Repeated dose studies are available for the three boundary substances, GLP compliant study on both 4,4’-MDI and pMDI with reliability 2, conducted according to OECD Guideline 453 (combined chronic toxicity/carcinogenicity studies) and two 28 day studies on pMDI and 4,4’-MDI/DEG/HMWP. Consistent with the hypothesized MoA proposed (see category justification document) for these substances the primary health effect following inhalation exposure is local irritation within the respiratory tract without significant systemic exposure or toxicity. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb780ccf-2596-4438-ae9d-ea7da43e1955/documents/3c2aa6cb-5926-4781-bf26-ff77265a67f0_a3634a8c-569e-45e1-97d8-22d868b54dc9.html,,,,,, "4,4'-Methylenediphenyl diisocyanate, oligomers",25686-28-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb780ccf-2596-4438-ae9d-ea7da43e1955/documents/3c2aa6cb-5926-4781-bf26-ff77265a67f0_a3634a8c-569e-45e1-97d8-22d868b54dc9.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1 mg/m3,adverse effect observed, "4,4'-Methylenediphenyl diisocyanate, oligomers",25686-28-6,"Data gap filling for the acute inhalation toxicity endpoint is achieved using the category approach according to ECHA guidance on read-across (ECHA, 2017c). For this endpoint, all effects are consistent with the hypothesized MoA and direct electrophilic reactions of NCO with biological nucleophiles. Modified MDI substances contain different higher molecular weight constituents, and all have in common a high content of bioaccessible low molecular weight MDI constituents responsible for presenting NCO reactivity, scenario 4 or 6 according to the RAAF considered as most appropriate due to a common mechanism. Selection between scenario 4 and 6 depends essentially upon the presence of variation in the properties i.e. magnitude of effect. Since it has been demonstrated that the bioaccessible low molecular weight MDI constituents are responsible for presenting NCO reactivity, and the higher molecular weight MDI constituents do not contribute to the observed toxicity it is reasonable to assume that their presence in these mixtures attenuates toxicity. Further, as a worst-case approach is adopted in which 4,4’-MDI isomer is used for read-across to all substances of the MDI category, then use of RAAF Scenario 4 (variations in the properties observed among source substances) is justified over scenario 6.   Acute oral toxicity In the case of oral exposure, before the reactive NCO groups present on the substances of the MDI category have opportunity to react locally, or be absorbed, they polymerize in the acid environment of the stomach to form solid polyureas that are excreted via the feces without being absorbed. Consequently, if exposure were to occur by the oral route this would not lead to local or systemic effects. For MDI Mixed Isomers, the key study (Reliability 1) did not record mortality up to the limit dose of 2,000 mg/kg bw . A supporting study describing the acute oral toxicity of pMDI conducted similar to OECD 401 guideline (Reliability 2) also did not find any mortality up to the maximum dose tested, hence the LD50 is greater than 10,000 mg/kg bw . Other studies on MDI substances are consistent with this, albeit with lower reliability.  Four additional acute oral toxicity studies (Reliability 1) have been conducted on other representative substances of the category subgroups (i.e. ‘MDI, its condensation products and the reaction products with glycols’ and ‘MDI and its reaction products with glycols’). In all cases, there was no mortality up to the limit dose (5,000 mg/kg). The lack of mortality in the available acute oral toxicity across the available studies, alongside the lack of gross lesions in distal tissues (e.g. liver, kidney etc.) supports the lack of systemic bioavailability. The NCO groups present on MDI substances react with acids within the stomach leading to formation of an insoluble polymerized mass that is excreted in the feces without being absorbed (see Toxicokinetics).  Supporting evidence comes in the form of several accidental ingestion reports in dogs where ingestion of MDI based glues produced no intrinsic toxic effects other than the formation of a solid polyurea mass that may lead to gastric obstruction. When the mass was removed by surgery, rapid and complete recovery was achieved (Horstman et al., 2003; Ohngren, 2007).     Acute dermal toxicity In the case of dermal exposure, before the reactive NCO groups present on MDI substances have opportunity to be absorbed to any significant extent through the stratum corneum they react with proteins and moisture at the skin surface leading to the formation of an insoluble polymerized mass thereby limiting dermal absorption and systemic availability (Leibold 1999). Modified MDI substances, having a higher molecular weight than mMDI isomers and due to their higher molecular volume, increased octanol-water partition coefficient and decreased water solubility will in any event not be able to penetrate the stratum corneum (Bartels 2021). The available acute dermal toxicity studies indicate that all substances of the MDI category have low acute dermal toxicity. The key study describing the acute dermal toxicity of pMDI in rabbits did not find lethality up to the maximum dose tested, and the LD50 was greater than 9,400 mg/kg bw (Wazeter et al., 1964a). Other less reliable studies on pMDI or 4,4’-MDI are consistent with this.  Observed differences in LD50 values between pMDI and 4,4'-MDI/TPG are not considered to be significant or represent a trend since they are significantly higher than the limit for classification and are indicative of a lack of systemic exposure. The available data for the substances of the MDI category is consistent with the hypothesis that NCO groups present on MDI substances react with proteins and moisture at the skin surface leading to the formation of an insoluble polymerized mass resulting in limited dermal absorption and systemic availability. The available data and hypothesis is supported by the key dermal absorption study that shows that MDI substances have very low systemic bioavailability (<1 %) (Leibold et al., 1999). By comparison, modified MDI substances, with molecular weight greater than mMDI, will demonstrate even further reduced dermal absorption based upon physico-chemical properties (i.e. increased octanol-water partition coefficient, decreased water solubility, and increased molecular weight), and this has been confirmed with GastroPlus™ modeling (Bartels, 2021). Although a reliable, acute dermal in vivo toxicity data is only available on two category substances, it is considered sufficient for assessment of this endpoint for the category. Due to the low predicted dermal bioavailability of all category substances, and the lack of systemic toxicity demonstrated in the oral acute toxicity studies, additional testing is not justified as all substances of the MDI category would be predicted to have comparable or reduced acute dermal toxicity potential to tested substances.   Acute Inhalation Toxicity Following inhalation exposure the initiating event in hypothesised MoA for acute toxicity in the lung is the reaction of the MDI substance with GSH in the airway lining fluid (adduct formation). Subsequent development of toxic effects is driven by the rate of depletion of GSH. This depletion begins with the reduction in extracellular GSH, which leads to a reduction in intracellular GSH disturbing the redox balance in the cell. With increasing amounts of NCO exposure (e.g. via exposure concentration or bioaccessibility), the protective GSH system gradually becomes overwhelmed, and toxicity evolves along the path: (1) no cytotoxicity; (2) cytotoxic effects; (3) reduced cell viability; and (4) cell death. This is accompanied by increasing extravasation because of increased junction permeability and epithelial damage ultimately causing edema.    The rate of nucleophile depletion by MDI-based substances is driven by the availability of the NCO-group, which itself is a function of (1) the NCO value of the substance and (2) the molecular weight of its constituents (driving its reactive dissolution). Monomeric MDI isomers have been shown to become available at a similar rate in toxicokinetic studies (Wisnewski, 2018; Wisnewski et al., 2019a) which is consistent with the generally comparable LC50 values for all of the isomers. Conversely, higher molecular weight constituents have both a reduced NCO value and exhibit reduced water solubility, making them less accessible to react with GSH. Therefore, the substances with the highest available NCO value and bioaccessibility (mMDI and three-ring oligomers) are the most toxic, while those with increasing amounts constituents less able to react with GHS demonstrate reduced toxicity.   Tests also show that toxicity is limited to portal-of-entry effects. The absence of systemic toxicity is due to the extracellular reactions described above, combined with transcarbamoylation to proteins described in more detail in the Chapter (Toxicokinetics), constitute a detoxification mechanism. Acute toxicity is only observed when this protective mechanism becomes overwhelmed and is limited to the lung. This mode of action is supported with high confidence by reliable acute inhalation data available for multiple MDI isomers and modified MDI substances (described in more detail below). The toxicity of MDI substances will decrease with increasing average molecular weight as these substances will have constituents that are less bioaccessible and with a lower NCO value. For these substances, higher exposure concentration is required to induce toxic effects, which is consistent with the observed results from the available acute inhalation toxicity tests.  Testing proposal: While testing is available on 8 MDI category memeber (including all sub-groups) acute toxicity testing (OECD 403) will be performed on an additional 4 MDI substances.  This information will further support the category hypothesis as well as help to define substance selection and study design for repeat-dose bridging studies.    Available data: The ‘Monomeric MDI’ subgroup Reliable acute inhalation studies are available for all three isomers of mMDI (2,2’-; 2,4’-; and 4,4’-MDI) in accordance with OECD Guideline 403 in a series of studies by (Pauluhn, 2008d; Pauluhn, 2008e; Pauluhn, 2008f). All three substances consist of more than 98 % pure mMDI, corresponding to NCO value of 33%. In all cases, mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA. LC50s were comparable and ranged from 368 to 598 mg/m3 for males and from 559 to 686 mg/m3 for females. For all studies, exposure parameters met internationally recognized recommendations for MMAD and GSD and were similar for all three isomers. The ‘Oligomeric MDI’ subgroup Polymeric MDI (approximately 40 % mMDI; 33 % NCO value, with viscosity of approximately 200 mPas) was tested in an acute inhalation toxicity study according to OECD 403 (Pauluhn, 2008c). Mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA. An LC50 (95 % confidence interval) of 310.2 (266.4-361.3) mg/m3 was determined for pMDI.  Polymeric MDI was also tested following depletion of monomeric MDI resulting in a mixture of 1.2 % mMDI and 98.8 % of higher (> two-ring) oligomers according to OECD 403 (Pauluhn, 2011a). The combined LC50, for male and female rats, for ‘monomer-depleted pMDI’ was greater than 2,188 mg/m3. Average mean mass aerodynamic diameter (MMAD) and geometric standard deviation (GSD) was generally comparable to that of the pMDI containing mMDI (85-87 %). The ‘MDI and its condensation products’ subgroup The acute inhalation toxicity of MDI Mixed isomers/PIR (60 % mMDI and NCO value of 26 %) was tested in an acute inhalation toxicity study according to OECD 403 (Pauluhn, 2012). The combined LC50 for male and female rats was 1,088 mg/m3, mortality was linked to portal of entry effects of the respiratory system, including severe irritation and pulmonary edema. Mortality occurred up to two days post-exposure and was causally related to an acute pulmonary edema. The ‘MDI and its reaction products with glycols’ subgroup Two reliable acute inhalation studies are available for substances of the ‘MDI and its reaction products with glycols’ subgroup. The acute inhalation toxicity of 4,4'-MDI/1,3-BD/TPG/PG (60 % mMDI; 23 % NCO) was conducted according with OECD 403 (Kopf, 2016).  The LC50 was calculated to be 518 mg/m3, and mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA.  The acute inhalation study of 4,4'-MDI/DPG/HMWP (50 % mMDI; 25 % NCO) was tested according to OECD 403 (Hotchkiss and Weidemoyer, 2020). The LC50 is 1,110 mg/m3 for male rats and 1,250 mg/m3 for female rats. The four-hour LC50 is 1.15 mg/L for male and female rats combined. Similar to the other LC50 studies, mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA.   An acute inhalation study was performed in rats at only one concentration level of 2.24 mg/L/1h (Pauluhn 2003, 2004). This study was specifically designed to comply with NFPA 704, and also complied with the limit test of the OECD guideline 403 with deviations (only 1 hr exposure, concentration lower than limit test concentration) and is therefore reliable with restrictions. Exposure of 4,4’-MDI for 1 hr resulted in mortality shortly after exposure of one out of ten rats. Clinical signs were characterised by typical signs of respiratory tract irritation. Necropsy findings were unremarkable in surviving rats, whilst the rat that succumbed displayed signs of lung oedema which was considered to be the cause of death. The LC50 >2.24 mg/L/1h (analytical) in both males and females was determined.        Adequacy of the available data for risk assessment and classification purposes Using the strict GHS LC50 cut-off for classification, the LC50 values obtained for the mMDI would trigger a Category 2 (or Category 3) according to GHS CLP. However, classification for these substances according to ECHA CLP Guidance (2017) text allows for the application of scientific judgement. It must be considered that the LC50 cut-off of 500 mg/m3 (approximately 50 ppm for pMDI), is over 2,500-fold above the saturated vapor concentration for pMDI. This difference is even further exacerbated in the pre-polymer mixtures where the presence of the higher molecular weight fraction even further reduces the vapor pressure making exposure less likely.    Furthermore, the aerosols were generated using sophisticated techniques in the laboratory, whereby extremely small particles are generated in order to meet international guidelines for testing. This size and concentration of aerosol is not generated in the workplace even under foreseeable worst-case conditions (Ehnes et al., 2019). The particle size distribution of aerosols formed during actual spraying applications has virtually no overlap with that of the highly respirable aerosol generated in inhalation studies (see EC (2005)). Due to a very low vapor pressure (<0.01 Pa) MDI substances are not inherently toxic by inhalation since the saturated vapor concentration would be orders of magnitude below toxic concentration. It is only with modification and input (in terms of heat, cooling and size screening) that MDI substances become toxic after inhalation. In the EU risk assessment report (EU 2005) MDI is classified as  harmful by inhalation.   The acute inhalation data of pMDI and 4,4’-MDI data were considered by EU experts, and their conclusion that MDI be classified as “Harmful” and  reported in the 25th Adaptation to Technical Progress (ATP) to the Dangerous Substances Directive (67/548/EEC). This was endorsed in the 28th ATP and both MDI substances remain as “Harmful” in the 30th ATP (adopted by Member States on 16 February 2007 and published 15th September 2008). The original decision was upheld in the EU Risk Assessment of MDI (Directive 793/93/EEC, 3rd Priority List) published in 2005, noting that considering “the exposure assessment, it is reasonable to consider MDI as harmful only and to apply the risk management phrase ‘harmful by inhalation’. This classification was also endorsed by the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE, now SCHER) in giving their opinion on the Risk Assessment (EC, 2008). With the enforcement of the CLP regulation (Regulation (EC) No 1272/2008) in 2009, the Dangerous Substance/Preparation Directive (DSD) was repealed and harmonized classifications were formally transferred to the CLP regulation; MDI is classified with Acute Tox. 4 H332 (Annex VI Regulation (EC) No 1272/2008 (CLP regu lation). Given the mechanism of action of the MDI substances and the changes in physical chemical properties imparted by the modifications in the modified MDI substances, the entire category is consistent with this guidance and classification, and the classification should not be changed.   The classification as “Harmful”, is equivalent to GHS Category 4. For these reasons, the GHS proposal follows the EU Regulatory lead accepting that the animal data are inappropriate and classified pMDI as GHS acute toxicity category 4 (ISOPA 2007).    Conclusion    Assessment of the available acute toxicity data indicates that inhalation exposure to the aerosols of MDI results in toxicity confined predominantly to the respiratory tract. In terms of hazard characterization, MDI is harmful by inhalation according to EU (H332) and GHS (Cat. 4) classification. MDI is non-toxic after single oral and dermal exposure.     Justification for classification or non classification:    EU classification according to CLP: H332     GHS classification (GHS UN rev.2, 2007): Inhalation route (vapour): Acute Category 4.     Not toxic by the dermal or oral routes. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Results are consistent within the key study Bomhard (1990) (reliability1)and data from a supporting study (Wazeter et al. 1964) (reliability 2). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb780ccf-2596-4438-ae9d-ea7da43e1955/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_a3634a8c-569e-45e1-97d8-22d868b54dc9.html,,,,,, "4,4'-Methylenediphenyl diisocyanate, oligomers",25686-28-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb780ccf-2596-4438-ae9d-ea7da43e1955/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_a3634a8c-569e-45e1-97d8-22d868b54dc9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-Methylenediphenyl diisocyanate, oligomers",25686-28-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb780ccf-2596-4438-ae9d-ea7da43e1955/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_a3634a8c-569e-45e1-97d8-22d868b54dc9.html,,inhalation,LC50,431 mg/m3,adverse effect observed, "4,4'-oxydi(benzenesulphonohydrazide)",80-51-3,"The repeated oral toxicity of OBSH was evaluated in 4 studies:   - In a 28D toxicity study in rodents (OECD 407), OBSH was administered to the rats by gavage at doses of 0 (vehicle), 10, 30, 100 and 200 mg/kg. The kidneys are considered as the most sensitive organ in this 28-day study. The NOEL was 10 mg/kg bw/day based on increased absolute and relative kidney weight at 30 mg/kg/d. At both dose levels of 100 mg/kg/d and 200 mg/kg /d fatty degeneration of proximal tubular epithelium in the kidneys were obseerved.   - In a combined repeated dose toxicity study with reproduction/developmental toxicity screening (OECD 422), OBSH was administered via gavage at doses of 0, 5, 15 and 45 mg/kg bw/day for 42 days for males and 42 to 54 days for females. Repeated oral dosing of OBSH induced salivation and enlargement of the adrenal glands in a dose-dependent manner in all male traetment groups. Significant increases in the spleen and left kidney weights at 15 mg/kg bw/day and above and in the adrenal glands weights at 45 mg/kg bw/day was observed in male rats. The weights of the liver and kidneys were significantly increased in both sexes at 45 mg/kg bw/day. Based on the findings, a LOAEL for male of 5 mg/kg bw/day and a NOAEL for female of 15 mg/kg bw/day was established based on changes in liver weight.   - In a combined repeated dose and reproductive/developmental toxicity study (OECD 421) using oral gavage as the route of administration, groups of 10 rats of each sex were given dose levels of 0, 3, 10 or 30 mg OBSH/kg bw/day. The exposure period for the males was a total of 46 days begning 14 days before mating and females from 14 days before mating to day 4 of lactation throughout the mating and pregnancy period. There were no effect on bodyweight and no relevant histopathological changes. The relative weight of the kidneys was significantly increased at 10 mg/kg bw/day. Significant increases in the absolute and relative weights of the kidneys in both sexes and in the relative weight of the liver in males were found at 30 mg/kg bw/day. Based on the findings, the NOEL for repeated dose toxicity (46 days) in parents was considered to be 3 mg/kg bw/day.   - In a 90D repeated dose toxicity study using oral gavage as the route of administration, groups of 10 rats of each sex were given dose levels of 0, 2, 10 or 50 mg OBSH/kg bw/day. Test item-related salivation was observed at≥10 mg/kg in both sexes but resolved before the next dosing. In hematology, absolute and relative reticulocytes in both sexes and absolute and relative neutrophil counts in females were increased at 50 mg/kg/day. In clinical chemistry, aspartate aminotransferase (AST) at 50 mg/kg/day and alanine aminotransferase (ALT) at 10 and 50 mg/kg/day were decreased in both sexes. Increases in total bilirubin (TBIL), triglyceride (TG), inorganic phosphorus (IP) and potassium (K) and a decrease in glucose (GLU) were observed in females at 50 mg/kg/day. Increased kidneys and liver weights were observed in both sexes at 50 mg/kg/day. In microscopic examination, minimally increased extramedullary hematopoiesis (EMH) in the spleen was observed in both sexes at 50 mg/kg/day. This change was associated with an increase of reticulocyte. Based on these findings, a NOAEL of 10 mg/kg bw/day for repeated dose toxicity (90D) was derived for both sexes.   Based on the available experimental data, a NOAEL of 10 mg/kg bw/day for systemic effects of OBSH can be established for subchronic repeated exposure.     No data available for inhalational or dermal route of exposure.     Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch score 1. The study was performed in accordance with the OCED guideline 421 and according to GLP standard. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2187ba3f-4bc3-4b0e-b84c-110332872e0a/documents/IUC5-6f779c5d-e18a-439c-80eb-4b4320d6b667_70962d2d-e56c-42ba-be86-3af1d484d15d.html,,,,,, "4,4'-oxydi(benzenesulphonohydrazide)",80-51-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2187ba3f-4bc3-4b0e-b84c-110332872e0a/documents/IUC5-6f779c5d-e18a-439c-80eb-4b4320d6b667_70962d2d-e56c-42ba-be86-3af1d484d15d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "4,4'-oxydi(benzenesulphonohydrazide)",80-51-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study was performed in accordance with OECD guideline 401 and GLP standard - Klimisch score 1. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): A recently performed OECD 436 study performed in accordance to GLP standards - Klimisch score 1. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): No reliable dermal acute toxicity study is available. A dermal toxicity study (reliability score 4) is available using 200 mg/kg of OBSH. No effeccts were seen after 24 hours. The original reference is not available. This study was not conducted according to GLP standard. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2187ba3f-4bc3-4b0e-b84c-110332872e0a/documents/IUC5-2d7f6856-cfcb-4a29-8a40-845747a603c3_70962d2d-e56c-42ba-be86-3af1d484d15d.html,,,,,, "4,4'-oxydi(benzenesulphonohydrazide)",80-51-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2187ba3f-4bc3-4b0e-b84c-110332872e0a/documents/IUC5-2d7f6856-cfcb-4a29-8a40-845747a603c3_70962d2d-e56c-42ba-be86-3af1d484d15d.html,,oral,LD50,"1,500 mg/kg bw",adverse effect observed, "4,4'-oxydiphthalic anhydride",1823-59-2," In a test according to EU Method B.1, the test item was found to have an oral LD50 value > 5000 mg/kg bw. Hence, classification for acute oral toxicity is not required. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b187b9f-50fb-4590-ab64-3e4bdec32372/documents/9695e292-5be1-4f5d-be0f-8db9c8d8076e_1573e99f-7c0d-4d5a-b7e3-21ad4eb28417.html,,,,,, "4,4-piperidinediol, hydrochloride",40064-34-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e32176d-89d5-4855-8a96-542218b39a7e/documents/c2795806-4d80-424f-92c7-a22d46d7cce1_15db5329-07c8-4378-b7ff-ba70ff1f3d73.html,,oral,discriminating dose,"5,000 mg/kg bw",adverse effect observed, "4,4'-sulfonylbisphenol, polymer with ammonium chloride(NH4Cl), pentachlorophosphorane and phenol",260408-02-4,"A 28-day repeated dose toxicity study performed in accordance with GLP principles is available. The NOAEL was determined to be 627 mg/kg bw/day in males based on effects on on the liver as centrilobular hepatocyte hypertrophy observed at 1910 mg/kg bw/day. No adversity was observed in females up to and including 2090 mg/kg bw/day. In a reproductive/developmental screening test (OECD TG 421, GLP) additional parameters were included for effects on the liver (weight, histopathology). In this no adversity was observed up to and including the highest dose level tested (1063 mg/kg bw/day). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A reliable study was used (Klimisch 1). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ccb52d60-a4c3-4bfa-8c8a-eebd34361c7e/documents/14292809-4c3b-4561-b9d5-f6bc86aae8c6_1a99989a-a2da-43d8-b53d-ab602c36e134.html,,,,,, "4,4'-sulfonylbisphenol, polymer with ammonium chloride(NH4Cl), pentachlorophosphorane and phenol",260408-02-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ccb52d60-a4c3-4bfa-8c8a-eebd34361c7e/documents/14292809-4c3b-4561-b9d5-f6bc86aae8c6_1a99989a-a2da-43d8-b53d-ab602c36e134.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4,4'-sulfonylbisphenol, polymer with ammonium chloride(NH4Cl), pentachlorophosphorane and phenol",260408-02-4," In an acute oral toxicity study with the substance performed in accordance with OECD TG 423, an LD50 of >2000 mg/kg bw was determined. In an acute dermal toxicity study with the substance performed in accordance with OECD TG 402, an LD50 of >2000 mg/kg bw was determined. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccb52d60-a4c3-4bfa-8c8a-eebd34361c7e/documents/a21962e9-a4c8-4887-9445-c4de17e16246_1a99989a-a2da-43d8-b53d-ab602c36e134.html,,,,,, "4,4'-sulfonylbisphenol, polymer with ammonium chloride(NH4Cl), pentachlorophosphorane and phenol",260408-02-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccb52d60-a4c3-4bfa-8c8a-eebd34361c7e/documents/a21962e9-a4c8-4887-9445-c4de17e16246_1a99989a-a2da-43d8-b53d-ab602c36e134.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-sulfonylbisphenol, polymer with ammonium chloride(NH4Cl), pentachlorophosphorane and phenol",260408-02-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccb52d60-a4c3-4bfa-8c8a-eebd34361c7e/documents/a21962e9-a4c8-4887-9445-c4de17e16246_1a99989a-a2da-43d8-b53d-ab602c36e134.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,4'-thiodiethylene hydrogen -2-octadecenylsuccinate",93882-40-7,Sub-acute (28 day): NOAEL local = 300 mg/kg bw/day; NOAEL systemic = 300 mg/kg bw/day (OECD 407). . ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93638e8a-9e74-48d8-af5a-07ccea62f425/documents/d1fe94cd-2042-459b-8085-cc25427e4d75_4f3543be-bf67-48f6-ad8b-fa2fde1726b9.html,,,,,, "4,4'-thiodiethylene hydrogen -2-octadecenylsuccinate",93882-40-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93638e8a-9e74-48d8-af5a-07ccea62f425/documents/d1fe94cd-2042-459b-8085-cc25427e4d75_4f3543be-bf67-48f6-ad8b-fa2fde1726b9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "4,4'-thiodiethylene hydrogen -2-octadecenylsuccinate",93882-40-7, One acute oral toxicity studies are available for the Substance. The acute oral toxicity study concluded that the Acute Oral LD50 was > 10000 mg/kg One acute dermal toxicity studies are available for the Substance. The acute dermal toxicity study concluded that the Acute dermal LD50 was > 3160 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93638e8a-9e74-48d8-af5a-07ccea62f425/documents/7957c77d-f74a-4fb5-96c1-7b0b3c6ec62f_4f3543be-bf67-48f6-ad8b-fa2fde1726b9.html,,,,,, "4,4'-thiodiethylene hydrogen -2-octadecenylsuccinate",93882-40-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93638e8a-9e74-48d8-af5a-07ccea62f425/documents/7957c77d-f74a-4fb5-96c1-7b0b3c6ec62f_4f3543be-bf67-48f6-ad8b-fa2fde1726b9.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "4,4'-thiodiethylene hydrogen -2-octadecenylsuccinate",93882-40-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93638e8a-9e74-48d8-af5a-07ccea62f425/documents/7957c77d-f74a-4fb5-96c1-7b0b3c6ec62f_4f3543be-bf67-48f6-ad8b-fa2fde1726b9.html,,dermal,LD50,"3,160 mg/kg bw",no adverse effect observed, "4,4'-trimethylenedipiperidine",16898-52-5, Acute oral toxicity: 440 mg/kg bw in rats. Acute dermal toxicity: > 2000 mg/kg bw in rabbits ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db213795-b5a7-481a-899b-4d716284923e/documents/1ff46f14-0b22-4cd9-a23c-e2585775a8ab_b45c89fa-e285-4985-93ec-2085473efaf3.html,,,,,, "4,4'-trimethylenedipiperidine",16898-52-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db213795-b5a7-481a-899b-4d716284923e/documents/1ff46f14-0b22-4cd9-a23c-e2585775a8ab_b45c89fa-e285-4985-93ec-2085473efaf3.html,,oral,LD50,440 mg/kg bw,adverse effect observed, "4,4'-trimethylenedipiperidine",16898-52-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db213795-b5a7-481a-899b-4d716284923e/documents/1ff46f14-0b22-4cd9-a23c-e2585775a8ab_b45c89fa-e285-4985-93ec-2085473efaf3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,5,6,7-tetrahydro-1H-benzotriazole",6789-99-7," In rats, the LD50 after oral administration was 2100 mg/kg body weight. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa7f4ba8-e81f-4161-a2a0-38ffe6aebff7/documents/a1c7cf56-db62-4976-aad2-1a4e06b467d0_1f39cd36-0178-4062-80c9-1bf7b7fda16c.html,,,,,, "4,5,6,7-tetrahydro-1H-benzotriazole",6789-99-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa7f4ba8-e81f-4161-a2a0-38ffe6aebff7/documents/a1c7cf56-db62-4976-aad2-1a4e06b467d0_1f39cd36-0178-4062-80c9-1bf7b7fda16c.html,,oral,LD50,"2,100 mg/kg bw",adverse effect observed, "4,5-bis(hydroxymethyl)-2-phenyl-1H-imidazole",61698-32-6,"- Acute toxicity via oral route: Rat Oral LD50 Cut-off (Females) = 5000 mg/kg bw (OECD 423, GLP, K, rel.1) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The key study is GLP-compliant and of high quality (Klimisch score = 1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5367dfb-9e5a-4c33-810e-c72c4fd6015a/documents/466c4896-be1b-4336-96a9-df94b69a80cf_1d2cee59-b019-4e3e-bb11-f2c78c6b8ba4.html,,,,,, "4,5-bis(hydroxymethyl)-2-phenyl-1H-imidazole",61698-32-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5367dfb-9e5a-4c33-810e-c72c4fd6015a/documents/466c4896-be1b-4336-96a9-df94b69a80cf_1d2cee59-b019-4e3e-bb11-f2c78c6b8ba4.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "4,5-dichloro-2-nitroaniline",6641-64-1," LD50 was estimated to be 48.45mg/kg bw, when rats were exposed with 4,5-Dichloro-2-nitroaniline (6641-64-1)orally. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4f007de-b182-4c5f-8a05-5d4365aef202/documents/372e6f19-4edf-4a23-9c3e-ce819ceaa87f_7f21565f-b890-49f5-81b1-4cae243ffb4f.html,,,,,, "4,5-dichloro-2-nitroaniline",6641-64-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4f007de-b182-4c5f-8a05-5d4365aef202/documents/372e6f19-4edf-4a23-9c3e-ce819ceaa87f_7f21565f-b890-49f5-81b1-4cae243ffb4f.html,,oral,LD50,48.45 mg/kg bw,adverse effect observed, "4,5-dihydro-5-oxo-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid",10149-98-1," Acute oral toxicity:  Acute oral toxicity dose (LD50) of 4,5-dihydro-5-oxo-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl] phenyl]azo]-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid (CAS no: 10149-98-1) was predicted based on OECD QSAR toolbox 8100 mg/kg bw and different studies available on structurally similar read across substances Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]- 2-naphthalenesulfonic acid complex (CAS No: 15790-07-5) >2000 mg/kg bw and Tartrazine (CAS No: 1934-21-0) >6250 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 4,5-dihydro-5-oxo-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1-(4-sulphophenyl)- 1H-pyrazole-3-carboxylic acid cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  4,5-dihydro-5-oxo-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl] phenyl]azo]-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid (CAS no: 10149-98-1) has very low vapour pressure (6.62E-26 Pa at 25°C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for 4,5-dihydro-5-oxo-4-[[4-[[2-(sulphooxy)ethyl] sulphonyl]phenyl]azo]-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid (CAS no: 10149-98-1) was predicted based on OECD QSAR toolbox 3617 mg/kg bwand differentstudies available for the structurally similar read across substance Aluminium, 6-hydroxy-5-[(4-sulfophenyl) azo]-2-naphthalenesulfonic acid complex (CAS No: 15790-07-5) >2000 mg/kg bw and for the functionally similar read across substance Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate (CAS No. 2519-30-4) >2000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 4,5-dihydro-5-oxo-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo] -1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid cannot be classified for acute dermal toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc32abfc-1980-46b3-9e83-2d6dc315aa2e/documents/8b3f474a-fb78-4755-bf0a-f63383a0ae28_9d540058-6047-4f6f-b63f-97db93b438f6.html,,,,,, "4,5-dihydro-5-oxo-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid",10149-98-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc32abfc-1980-46b3-9e83-2d6dc315aa2e/documents/8b3f474a-fb78-4755-bf0a-f63383a0ae28_9d540058-6047-4f6f-b63f-97db93b438f6.html,,oral,LD50,"8,100 mg/kg bw",no adverse effect observed, "4,5-dihydro-5-oxo-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid",10149-98-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc32abfc-1980-46b3-9e83-2d6dc315aa2e/documents/8b3f474a-fb78-4755-bf0a-f63383a0ae28_9d540058-6047-4f6f-b63f-97db93b438f6.html,,dermal,LD50,"3,617 mg/kg bw",no adverse effect observed, "4,5-dihydro-5-oxo-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid, sodium salt",85567-10-8," Dose range finding 14-day repeated dose toxicity A dose range finding study was performed which preceeded the presented key 28-day repeated dose study. To assess the possible health hazards which could arise from repeated exposure of Reactive Yellow 42 via oral administration to rats, the test item was administered daily to 3 groups of test animals at 300, 600 and 1000 mg/kg bw/day for a treatment period of 14 days. There are no regulatory guidelines for this type of dose range-finding study, but the study design was based on the principles specified in OECD TG 407, the study was non-GLP. No NOAEL was determinded for this study as it served as a dose range finder. 28-Day repeated dose toxicity One key repeated dose toxicity study was performed according to OECD TG 422 and in compliance to GLP to assess the possible adverse effects of Reactive Yellow 42 on male and female Wistar rats after repeated dose administration with dose levels of 100, 300, and 1000 mg/kg body weight/day. The NOAEL for the test item under the condition of this study is considered to be > 1000 mg/kg bw/day for general toxicity. Repeated dose toxicity via other routes There are no studies available in which the repeated dose toxicity via inhalation or dermal route is assessed. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efcfa23c-bd03-444e-861a-07e63f60240d/documents/8d05b214-b70f-4178-bac6-1b058cc1bc24_b24b7608-d7b9-4d28-b218-7c658b8fc2bd.html,,,,,, "4,5-dihydro-5-oxo-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid, sodium salt",85567-10-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efcfa23c-bd03-444e-861a-07e63f60240d/documents/8d05b214-b70f-4178-bac6-1b058cc1bc24_b24b7608-d7b9-4d28-b218-7c658b8fc2bd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4,5-dihydro-5-oxo-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid, sodium salt",85567-10-8," Two key studies are available for acute toxicity, an oral and a dermal study. Oral route: A single oral application of the registered substance to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality. The median lethal dose of the test item after a single oral administration to female rats, observed over a period of 14 days was > 2000 mg/kg bw. Dermal route: A single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity nor signs of dermal irritation. The dermal LD50 was determined to be > 2000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efcfa23c-bd03-444e-861a-07e63f60240d/documents/7f569628-bf4f-4fa1-9860-95a5780a8fb2_b24b7608-d7b9-4d28-b218-7c658b8fc2bd.html,,,,,, "4,5-dihydro-5-oxo-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid, sodium salt",85567-10-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efcfa23c-bd03-444e-861a-07e63f60240d/documents/7f569628-bf4f-4fa1-9860-95a5780a8fb2_b24b7608-d7b9-4d28-b218-7c658b8fc2bd.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,5-dihydro-5-oxo-4-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid, sodium salt",85567-10-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efcfa23c-bd03-444e-861a-07e63f60240d/documents/7f569628-bf4f-4fa1-9860-95a5780a8fb2_b24b7608-d7b9-4d28-b218-7c658b8fc2bd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,5-dihydroxy-1,3-dimethylimidazolidin-2-one",3923-79-3,"In the key oral 90-day repeated-dose toxicity study in rats according to OECD guideline 408, the test item did not cause adverse effects in male or female Han:WIST rats after 90-day consecutive oral (by gavage) administration of 100, 300 or 1000 mg/kg bw/day (corresponding to doses of 236, 710 and 2360 mg/kg bw/day of the product). There were no toxic changes in the examined parameters (clinical signs, body weight and body weight gain, food intake, ophthalmology, hematology, blood coagulation and clinical chemistry, serum levels of thyroid hormones, urinalysis, estrous cycle, necropsy findings, organ weights or histopathological findings). Based on the observations made in this toxicity study the NOAEL was 1000 mg/kg bw/day in male and female Han: WIST rats.   In the supporting range-finding study, 4,5-dihydroxy-1,3-dimethylimidazolidin-2-one did not cause adverse effects in male or female Han: WIST rats after consecutive 14-day oral (by gavage) administration at the doses of 100, 300 or 1000 mg/kg bw/day. Based on the observations made in this toxicity study, the following dose levels for a 90-Day Repeated Dose Oral Toxicity Study of 4,5-dihydroxy-1,3-dimethylimidazolidin-2-one in Rats (main study) are suggested: 100, 300 and 1000 mg/kg bw/day (corresponding to 236, 710 and 2360 mg/kg bw/day of the product). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7db0c4b-8be2-4d18-ac38-5ba2dcbfc3a8/documents/b2ccd957-fcbf-4968-ba54-1765ec52f043_18ea8dd0-6d63-4677-9148-d4dbad306f8f.html,,,,,, "4,5-dihydroxy-1,3-dimethylimidazolidin-2-one",3923-79-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7db0c4b-8be2-4d18-ac38-5ba2dcbfc3a8/documents/b2ccd957-fcbf-4968-ba54-1765ec52f043_18ea8dd0-6d63-4677-9148-d4dbad306f8f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4,5-dihydroxy-1,3-dimethylimidazolidin-2-one",3923-79-3,"In the key Acute Oral Toxicity Study, the LD50 was >2000 mg/kg bw in male and female rats.   In the key acute dermal toxicity study, the LD50 was >3300 mg/kg bw in male and female rats. In a supporting study in male and female rats according to OECD guideline 402, the LD50 was >2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7db0c4b-8be2-4d18-ac38-5ba2dcbfc3a8/documents/50a3f4c8-2bda-44b0-a954-b1da0454ef26_18ea8dd0-6d63-4677-9148-d4dbad306f8f.html,,,,,, "4,5-dihydroxy-1,3-dimethylimidazolidin-2-one",3923-79-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7db0c4b-8be2-4d18-ac38-5ba2dcbfc3a8/documents/50a3f4c8-2bda-44b0-a954-b1da0454ef26_18ea8dd0-6d63-4677-9148-d4dbad306f8f.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4,5-dihydroxy-1,3-dimethylimidazolidin-2-one",3923-79-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7db0c4b-8be2-4d18-ac38-5ba2dcbfc3a8/documents/50a3f4c8-2bda-44b0-a954-b1da0454ef26_18ea8dd0-6d63-4677-9148-d4dbad306f8f.html,,dermal,LD50,"> 3,300 mg/kg bw",no adverse effect observed, "4,6-bis(octylthiomethyl)-o-cresol",110553-27-0," In a repeated dose 90-day oral toxicity study in rats conducted according to the OECD Guideline 408, administration by gavage at a dose level up to 1000 mg/kg caused slight adaptive effects on liver. The NOEL was 10 mg/kg bw. In a 90-day oral gavage toxicity study conducted in dogs according to the OECD Guideline 409, a dose level up to 1000 mg/kg caused weak effects on liver enzymes and biliary cell proliferation possibly indicating adverse effects on liver. No effects were observed at 10 mg/kg bw. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82373c1f-6994-4de8-895c-3d4880b28612/documents/afcfe095-1179-489d-93f1-94086e8a6b0a_facc5ba3-9a03-473d-87a6-ecd4c2d4d661.html,,,,,, "4,6-bis(octylthiomethyl)-o-cresol",110553-27-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82373c1f-6994-4de8-895c-3d4880b28612/documents/afcfe095-1179-489d-93f1-94086e8a6b0a_facc5ba3-9a03-473d-87a6-ecd4c2d4d661.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "4,6-bis(octylthiomethyl)-o-cresol",110553-27-0," The test item is of low acute oral and dermal toxicity with an LD50 greater than 5000 mg/kg bw  for the oral route and an LD50 greater than 2000 mg/kg bw for the dermal route, as shown in valid guideline studies performed pursuant to OECD Guidelines 401 (Acute Oral Toxicity) and 402 (Acute Dermal Toxicity), respectively. Experimental data on acute inhalation toxicity is not available. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82373c1f-6994-4de8-895c-3d4880b28612/documents/606cb32a-3d81-40f9-a82f-40fc998b4a86_facc5ba3-9a03-473d-87a6-ecd4c2d4d661.html,,,,,, "4,6-bis(octylthiomethyl)-o-cresol",110553-27-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82373c1f-6994-4de8-895c-3d4880b28612/documents/606cb32a-3d81-40f9-a82f-40fc998b4a86_facc5ba3-9a03-473d-87a6-ecd4c2d4d661.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "4,6-bis(octylthiomethyl)-o-cresol",110553-27-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82373c1f-6994-4de8-895c-3d4880b28612/documents/606cb32a-3d81-40f9-a82f-40fc998b4a86_facc5ba3-9a03-473d-87a6-ecd4c2d4d661.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4,6-dichloro-1,3,5-triazin-2(1H)-one, sodium salt",2736-18-7," A study according to OECD 423 was performed. With a dose of 2000mg/kg bw, administred orally to three male and three female rat there were no deaths. There wer no clinical signs of toxicity All animals showed expected gains in bodyweight. No abnomalities were noted at necropsy. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b78e72be-6c54-4b10-957a-158387c33238/documents/de43dd6e-b3d6-4e2c-be14-ab200ed16c5f_072878f2-5c4c-4e6a-856a-1cae32db4358.html,,,,,, "4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine",72058-41-4," Short-term repeated dose toxicity Subacute NOAEL (male/female, rat): 40 mg/kg bw/day (OECD 422/GLP) Sub-chronic repeated dose toxicity Based on the available information in the dossier (OECD 422/GLP), the substance 4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine (CAS No. 72058-41-4) is classified for specific target organ toxicity category 2 (repeated; oral (kidney); STOT-RE 2) when the criteria outlined in Annex I of 1272/2008/EC are applied. The results of this study are adequate for C&L and risk characterization; therefore, a sub-chronic 90-day repeated dose toxicity study is not necessary. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/760c4603-ee1d-4c04-97a8-c0979cd35540/documents/7eb41580-be6b-4c6c-aace-34369ed046dd_0f75901c-da7c-41a7-b3ba-68e4182acc98.html,,,,,, "4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine",72058-41-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/760c4603-ee1d-4c04-97a8-c0979cd35540/documents/7eb41580-be6b-4c6c-aace-34369ed046dd_0f75901c-da7c-41a7-b3ba-68e4182acc98.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat "4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine",72058-41-4, Acute oral toxicity: LD50 cut-off (female) = 2500 mg/ kg bw Acute dermal toxicity: LD50 >2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/760c4603-ee1d-4c04-97a8-c0979cd35540/documents/2871d913-5e32-4785-bac8-08a9a90f4d00_0f75901c-da7c-41a7-b3ba-68e4182acc98.html,,,,,, "4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine",72058-41-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/760c4603-ee1d-4c04-97a8-c0979cd35540/documents/2871d913-5e32-4785-bac8-08a9a90f4d00_0f75901c-da7c-41a7-b3ba-68e4182acc98.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "4,6-dichloro-N-(1,1,3,3-tetramethylbutyl)-1,3,5-triazin-2-amine",72058-41-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/760c4603-ee1d-4c04-97a8-c0979cd35540/documents/2871d913-5e32-4785-bac8-08a9a90f4d00_0f75901c-da7c-41a7-b3ba-68e4182acc98.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "4,6-dichloropyrimidine",1193-21-1,"Acute Toxicity Oral Stropp, 1996 Toxicological investigations in male and female rats were conducted after single oral administration of the test item. The LD50 was greater than 200 mg for the male and female rats. After administration of 2000 mg/kg body weight the following clinical signs were observed in female rats: dazed condition and apathy. Two of three animals died. After a single doese of 200 mg/kg no signs were observed in male rats, females showed piloerection up to 8 hours after application. Body weight development was not significantly affected in both sexes after 200 mg/kg. At necroscopy of the two intercurrent deaths females (2000 mg/kg) showed the following gross pathological findings: strong reddening of the muscosa in stomach and small intestine, liver mottled.  None of the animals sacrified at the end of study showed any noticeable gross pathological findings. The LD50 value for male and female rats is greater than 200 mg/kg and was not exactly determined.Based on the investigations, the test substance has to be regarded as harmful if swallowed. Due to the reporting of the experimental details, the study was rated with Klimisch score 1 (reliable without restriction) and is therefore used for the key value.  Acute Toxicity Dermal Mc Call, 1991 Based on the data the LD50 for acute dermal toxicity of the test item is considered to be greater than 400 mg/kg bw in rats. Based on the investigations, the test substance has to be regarded as harmful in contact with skin. A single dermal dose of 2000 mg/kg body weight was administered as paste in deionized to two male and two female rats. Following the dose signs of extremely servere skin irritation was observed in all animals. due to the severity of the symptoms the study was stopped after two days for reasons of animal welfare. At this time animals show signs of systemic toxicity.  The test was repeated with a lower sinle dermal dose of 400 mg/kg body weight to again two males and two female rats. Following the dose signs slightly systemic toxicity was observed in one male rat from day two to day eight. Signs of severe skin irritation were observed in all animals of this dose group and persists until the end of the study. Due to the reporting of the experimental details, the study was rated with Klimisch score 2 (reliable with restriction) and is therefore used for the key value. Inhalative ToxicityThe substance is handled as a hot melt (70 - 130°C) and exposure to hot vapours is therefore not excluded. With regard to acute oral and dermal toxicity, classification as acute inhalation is appropriate. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eeba8d04-0106-4fd9-bda6-66506c7b2f23/documents/52a1512f-113d-4779-ab61-5c4f02ebb629_b29aac30-ab6f-4900-b030-2937230f0521.html,,,,,, "4,6-dichloropyrimidine",1193-21-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eeba8d04-0106-4fd9-bda6-66506c7b2f23/documents/52a1512f-113d-4779-ab61-5c4f02ebb629_b29aac30-ab6f-4900-b030-2937230f0521.html,,oral,LD50,> 200 mg/kg bw,adverse effect observed, "4,6-dichloropyrimidine",1193-21-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eeba8d04-0106-4fd9-bda6-66506c7b2f23/documents/52a1512f-113d-4779-ab61-5c4f02ebb629_b29aac30-ab6f-4900-b030-2937230f0521.html,,dermal,LD50,"< 2,000 mg/kg bw",adverse effect observed, "4,6-dimethyl-2-(1-phenylethyl)-3,6-dihydro-2H-pyran",1945993-03-2," OECD 407: It was concluded that 4500 ppm represented theNo Observed Adverse Effect Level (NOAEL) when administered orally for 28 consecutive days to the rat. The substance was tested at dietary concentrations of 1500, 4500 and 9000 ppm (equivalent to a mean achieved dosage of 114.5, 340.5 and 676.1 mg/kg bw/day for males and 114.1, 311.9 and 615.4 mg/kg bw/day for females respectively). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f7d19cd-2d7a-4536-9ffc-9ebe814bad43/documents/12c2dd75-70e6-4c96-94a5-0f9cf2c9e255_835be369-d673-4309-8049-d92febbc09f8.html,,,,,, "4,6-dimethyl-2-(1-phenylethyl)-3,6-dihydro-2H-pyran",1945993-03-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f7d19cd-2d7a-4536-9ffc-9ebe814bad43/documents/12c2dd75-70e6-4c96-94a5-0f9cf2c9e255_835be369-d673-4309-8049-d92febbc09f8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,311.9 mg/kg bw/day,,rat "4,6-dimethyl-2-(1-phenylethyl)-3,6-dihydro-2H-pyran",1945993-03-2,Acute oral toxicity: OECD TG 420: LD50 > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f7d19cd-2d7a-4536-9ffc-9ebe814bad43/documents/48aea60a-0642-4e9a-9c60-1057bdf5a22a_835be369-d673-4309-8049-d92febbc09f8.html,,,,,, "4,6-dimethyl-2-(1-phenylethyl)-3,6-dihydro-2H-pyran",1945993-03-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f7d19cd-2d7a-4536-9ffc-9ebe814bad43/documents/48aea60a-0642-4e9a-9c60-1057bdf5a22a_835be369-d673-4309-8049-d92febbc09f8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3,5-Triazin-2(1H)-one, 4,6-diphenyl-",1917-44-8,"In a limit test with 2000 mg test substance/kg bw according to OECD TG 401 and GLP no mortalities have been observed.LD50, rat, oral: >2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14c46b12-c5e3-4473-a714-a368b579a057/documents/IUC5-9215ac15-6393-43a1-8922-fd6e3a1b850a_727d557d-cd1b-4a96-8167-44efae81e005.html,,,,,, "2,4,7,9-Tetramethyl-4,7-decanediol",17913-76-7," 28 d NOAEL = 150 mg/kg bw/d (rat, OECD TG 407, RL1: 0, 15, 150 or 1000 mg/kg bw/d) 91 d NOAEL = 500 mg/kg bw/d (rat, combined repeated dose/1 generation reproduction study, no guideline; RL2: 0, 500, 1000, 2000 mg/kg bw/d) (read-across from 2,4,7,9-Tetramethyl-5-decyne-4,7-diol ) 91 d NOAEL = 250 mg/kg bw/d (beagle dog, no guideline, RL2: 0, 200, 250 and 300 mg/kg/day) (read-across from 2,4,7,9-Tetramethyl-5-decyne-4,7-diol) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1cfdb66b-e9ed-4072-b80f-e483337a0eca/documents/d714e1a6-9d16-4dd4-bc67-7cfdbd5b2170_adea2916-beb0-4975-9ecb-a5ed86c739ca.html,,,,,, "2,4,7,9-Tetramethyl-4,7-decanediol",17913-76-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1cfdb66b-e9ed-4072-b80f-e483337a0eca/documents/d714e1a6-9d16-4dd4-bc67-7cfdbd5b2170_adea2916-beb0-4975-9ecb-a5ed86c739ca.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "2,4,7,9-Tetramethyl-4,7-decanediol",17913-76-7," oral LD50 > 2000 mg/kg bw inhalation LC50(1 h) > 20 mg/m³ (read-across from 2,4,7,9-Tetramethyl-5-decyne-4,7-diol) dermal LD50 > 2000 mg/kg bw (read-across from 2,4,7,9-Tetramethyl-5-decyne-4,7-diol) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1cfdb66b-e9ed-4072-b80f-e483337a0eca/documents/f23dd2f5-4e98-4c15-b2f4-db478e4fc978_adea2916-beb0-4975-9ecb-a5ed86c739ca.html,,,,,, "2,4,7,9-Tetramethyl-4,7-decanediol",17913-76-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1cfdb66b-e9ed-4072-b80f-e483337a0eca/documents/f23dd2f5-4e98-4c15-b2f4-db478e4fc978_adea2916-beb0-4975-9ecb-a5ed86c739ca.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,4,7,9-Tetramethyl-4,7-decanediol",17913-76-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1cfdb66b-e9ed-4072-b80f-e483337a0eca/documents/f23dd2f5-4e98-4c15-b2f4-db478e4fc978_adea2916-beb0-4975-9ecb-a5ed86c739ca.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "2,4,7,9-Tetramethyl-4,7-decanediol",17913-76-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1cfdb66b-e9ed-4072-b80f-e483337a0eca/documents/f23dd2f5-4e98-4c15-b2f4-db478e4fc978_adea2916-beb0-4975-9ecb-a5ed86c739ca.html,,inhalation,LC50,20 mg/m3,no adverse effect observed, "4,7-dichloroquinoline",86-98-6," Repeated dose toxicity: Oral Based on the available results and applying the weight of evidence approach, the NOAEL value can be considered to be 930 mg/kg/day. Hence, the test chemical can be classified under the category “Not Classified” for CLP Regulation.   Repeated Dose toxicity: Inhalation A short term inhalation toxicity study need not be conducted because exposure of humans via inhalation in production and/or in use is highly unlikely based on the thorough and rigourous risk assessment provided. The estimated vapour pressure for the test chemical was 0.093 Pa or 0.0007 mmHg at 25 deg C, also the primary route of exposure oral. Hence, exposure via inhalation route is highly unlikely. Repeated dose toxicity: Dermal A short term dermal toxicity study need not be conducted because exposure of humans via dermal in production and/or in use is highly unlikely based on the thorough and rigourous risk assessment provided. The acute dermal LD50 of the test chemical (as per section 7.2.3) was greater than 2000 mg/kg. Also the experimental in vitro skin irritation study suggests that the test chemical was not irritating to human skin. Hence this endpoint can be considered for waiver. Based on the available results and applying the weight of evidence approach, the NOAEL value can be considered to be 930 mg/kg/day. Hence, the test chemical can be classified under the category “Not Classified” for CLP Regulation.   ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07297503-b4fc-48b2-9945-addc280048db/documents/c42adc5c-cc73-4e3d-9805-fa8ac7f0678e_ab9b6159-adfd-4742-84cd-3a4205631722.html,,,,,, "4,7-dichloroquinoline",86-98-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07297503-b4fc-48b2-9945-addc280048db/documents/c42adc5c-cc73-4e3d-9805-fa8ac7f0678e_ab9b6159-adfd-4742-84cd-3a4205631722.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,930 mg/kg bw/day,,rat "4,7-dichloroquinoline",86-98-6," Acute Toxicity:Oral Based on the available results and applying the weight of evidence approach the acute oral LD50 value can be considered to be greater than 2000 mg/kg. Hence, the test chemical can be classified under the category “Not Classified” as per CLP Regulation Acute Toxicity: Inhalation The study doesnot need to be conducted due to the low vapor pressure of the chemical and its exposure as aerosols, dusts, mists or vapors of inhalable size during manufacture/use is highly unlikely.The estimated vapour pressure for the test chemical was 0.093 Pa or 0.0007 mmHg at 25 deg C, also the primary route of exposure oral. Hence, exposure via inhalation route is highly unlikely. Acute Toxicity: Dermal Based on the available results and applying the weight of evidence approach, the acute dermal LD50 for the test chemical can be considered to be greater than 2000 mg/kg. Hence, the test chemical can be classified under the category ""Not Classified"" as per CLP Regulation ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07297503-b4fc-48b2-9945-addc280048db/documents/b8f0f2ef-884f-4d66-9fb3-8c14d56d4315_ab9b6159-adfd-4742-84cd-3a4205631722.html,,,,,, "4,7-dichloroquinoline",86-98-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07297503-b4fc-48b2-9945-addc280048db/documents/b8f0f2ef-884f-4d66-9fb3-8c14d56d4315_ab9b6159-adfd-4742-84cd-3a4205631722.html,,oral,LD50,"2,350 mg/kg bw",no adverse effect observed, "4,7-dichloroquinoline",86-98-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07297503-b4fc-48b2-9945-addc280048db/documents/b8f0f2ef-884f-4d66-9fb3-8c14d56d4315_ab9b6159-adfd-4742-84cd-3a4205631722.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl-12H-dibenzo[d,g][1,3,2]dioxaphosphocin",73912-21-7," Repeated Dose toxicity: Subacute (28 day) study oral (gavage), rat (Wistar) m/f (OECD TG 407, GLP): NOAEL = 1000 mg/kg bw/d, no adverse effects observed up to the limit dose No specific target organ toxicity was identified, no classification as STOT RE Cat. 2 was triggered. Repeated Dose toxicity: Range-finding study (14 days), oral (gavage), rat (Wistar) m/f (GLP): NOAEL = 1000 mg/kg bw/d, no adverse effects observed up to the limit dose ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb4325a1-8908-463e-b9ef-2488b7569282/documents/f8de33a0-af08-46ec-9ba5-f34fe43c9630_0a6825a1-00e2-4c84-822a-93cad8bbcbd3.html,,,,,, "4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl-12H-dibenzo[d,g][1,3,2]dioxaphosphocin",73912-21-7,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb4325a1-8908-463e-b9ef-2488b7569282/documents/f8de33a0-af08-46ec-9ba5-f34fe43c9630_0a6825a1-00e2-4c84-822a-93cad8bbcbd3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl-12H-dibenzo[d,g][1,3,2]dioxaphosphocin",73912-21-7," Acute Toxicity Oral: Acute study oral (gavage), rat (Wistar) m/f, limit test (EU method B.1, GLP): LD50(oral) > 2000 mg/kg / LD0(oral) > 2000 mg/kg (males) Acute Toxicity Oral: Acute study oral (gavage), rat (Wistar) m (no guideline), LD50(oral) > 1000 mg/kg / LD0(oral) ≥ 1000 mg/kg Acute Toxicity Dermal: Acute study dermal (semi-occlusive), rat (Wistar) m/f, limit test (OECD guideline 402, GLP): LD50(dermal) > 2000 mg/kg / LD0(dermal) ≥ 2000 mg/kg ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb4325a1-8908-463e-b9ef-2488b7569282/documents/1e1b66db-2e35-4a1f-8dda-de09458597ae_0a6825a1-00e2-4c84-822a-93cad8bbcbd3.html,,,,,, "4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl-12H-dibenzo[d,g][1,3,2]dioxaphosphocin",73912-21-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb4325a1-8908-463e-b9ef-2488b7569282/documents/1e1b66db-2e35-4a1f-8dda-de09458597ae_0a6825a1-00e2-4c84-822a-93cad8bbcbd3.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl-12H-dibenzo[d,g][1,3,2]dioxaphosphocin",73912-21-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb4325a1-8908-463e-b9ef-2488b7569282/documents/1e1b66db-2e35-4a1f-8dda-de09458597ae_0a6825a1-00e2-4c84-822a-93cad8bbcbd3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,8-Dimethyl-2,5,7,10-tetraoxaundecane",59039-15-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0beeeaa-51c9-44ca-84eb-bfc21af7f049/documents/4fcc4f47-8efe-4899-a794-369e74f77e7d_1d100276-2ce4-4cd5-8e2f-1aa6013bb262.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4,8-Dimethyl-2,5,7,10-tetraoxaundecane",59039-15-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0beeeaa-51c9-44ca-84eb-bfc21af7f049/documents/e9f7e541-77fe-426e-8783-16ee4677f50f_1d100276-2ce4-4cd5-8e2f-1aa6013bb262.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4,8-Dimethyl-2,5,7,10-tetraoxaundecane",59039-15-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0beeeaa-51c9-44ca-84eb-bfc21af7f049/documents/e9f7e541-77fe-426e-8783-16ee4677f50f_1d100276-2ce4-4cd5-8e2f-1aa6013bb262.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4-[(1,5-dihydro-3-methyl-5-oxo-1-phenyl-4H-pyrazol-4-ylidene)methyl]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one",4702-90-3," In a GLP-compliant OECD 422 study male parental animals showed no signs of toxicity up to the highest dose level administered. In parental females, the gestation index (reduced to 66.7%) as well as the live birth index (58.1% due to the reduced number of females with live pups on the day of birth) were clearly affected at 1000 mg/kg body weight. The number of dams with stillborn pups was significantly increased at 1000 mg/kg and in 2 litters all pups were stillborn. The mean value of perinatal loss was significantly increased (47.2%) as well. The reason for the increased perinatal deaths as well as for dystocia were unknown but one effect might also cause the other. Therefore, at a critical internal dose level, the test substance (or a metabolite) affects either fetal life or the process of birthing or both. Thus, the no observed adverse effect level (NOAEL) for general systemic toxicity was 1000 mg/kg bw/d for male and 300 mg/kg bw/d for female Wistar rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e9b6c06-23e2-44f0-b23a-1064b426e18b/documents/dba6bdbb-4f58-4822-b03f-bd6be840d9f1_75e51a3c-d574-4a39-b7de-299a4e79107d.html,,,,,, "4-[(1,5-dihydro-3-methyl-5-oxo-1-phenyl-4H-pyrazol-4-ylidene)methyl]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one",4702-90-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e9b6c06-23e2-44f0-b23a-1064b426e18b/documents/dba6bdbb-4f58-4822-b03f-bd6be840d9f1_75e51a3c-d574-4a39-b7de-299a4e79107d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "4-[(1,5-dihydro-3-methyl-5-oxo-1-phenyl-4H-pyrazol-4-ylidene)methyl]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one",4702-90-3," The test article does not show acute toxicity when administered to rats by the oral, dermal oder inhalative route. The LD50 values were >6400 mg/kg and >2500 mg/kg body weight for oral and dermal route, respectively. No mortalities were reported in an inhalation risk test. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e9b6c06-23e2-44f0-b23a-1064b426e18b/documents/20a378dc-ae8b-4f55-bc7d-17d828391ce8_75e51a3c-d574-4a39-b7de-299a4e79107d.html,,,,,, "4-[(1,5-dihydro-3-methyl-5-oxo-1-phenyl-4H-pyrazol-4-ylidene)methyl]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one",4702-90-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e9b6c06-23e2-44f0-b23a-1064b426e18b/documents/20a378dc-ae8b-4f55-bc7d-17d828391ce8_75e51a3c-d574-4a39-b7de-299a4e79107d.html,,oral,LD50,"6,400 mg/kg bw",no adverse effect observed, "4-[(1,5-dihydro-3-methyl-5-oxo-1-phenyl-4H-pyrazol-4-ylidene)methyl]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one",4702-90-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e9b6c06-23e2-44f0-b23a-1064b426e18b/documents/20a378dc-ae8b-4f55-bc7d-17d828391ce8_75e51a3c-d574-4a39-b7de-299a4e79107d.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, "4-[(1,5-dihydro-3-methyl-5-oxo-1-phenyl-4H-pyrazol-4-ylidene)methyl]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-one",4702-90-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e9b6c06-23e2-44f0-b23a-1064b426e18b/documents/20a378dc-ae8b-4f55-bc7d-17d828391ce8_75e51a3c-d574-4a39-b7de-299a4e79107d.html,,inhalation,LC50,"7,390 mg/m3",no adverse effect observed, "4-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]-N-(3-ethoxypropyl)benzenesulphonamide",72363-26-9," Based on the read across data, the no observed adverse effect level (NOAEL) of Disperse Red 092 is considered to be 100 mg/kg/d for systemic toxicity in male and female rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b4294fa-77a4-40cd-b855-12a696a2170e/documents/31f3da1d-5516-4cb1-b4fe-2b406fe2ec47_faa7a3c5-03d2-4765-b6dd-603b65bbf91b.html,,,,,, "4-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]-N-(3-ethoxypropyl)benzenesulphonamide",72363-26-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b4294fa-77a4-40cd-b855-12a696a2170e/documents/31f3da1d-5516-4cb1-b4fe-2b406fe2ec47_faa7a3c5-03d2-4765-b6dd-603b65bbf91b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "4-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]-N-(3-ethoxypropyl)benzenesulphonamide",72363-26-9, The acute oral median lethal dose (LD50) of Disperse Red 092 in the female Wistar rat was estimated to be greater than 2000 mg/kg body weight. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b4294fa-77a4-40cd-b855-12a696a2170e/documents/86de9083-d9b3-407f-b5ad-90053e834c9c_faa7a3c5-03d2-4765-b6dd-603b65bbf91b.html,,,,,, "4-[(1-amino-9,10-dihydro-4-hydroxy-9,10-dioxo-2-anthryl)oxy]-N-(3-ethoxypropyl)benzenesulphonamide",72363-26-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b4294fa-77a4-40cd-b855-12a696a2170e/documents/86de9083-d9b3-407f-b5ad-90053e834c9c_faa7a3c5-03d2-4765-b6dd-603b65bbf91b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-[(1-butyl-5-cyano-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl)azo]-N-(2-ethylhexyl)benzenesulphonamide",55290-62-5,"In a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test in Wistar rats no adverse effects were reported. The NOAEL for general, systemic toxicity was at least 750 mg/kg bw/d. The NOEL for reproductive performance and fertility was at least 750 mg/kg bw/d in male and female Wistar rats. The NOEL for developmental toxicity was at least 750 mg/kg bw/d. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04d01869-6ff3-4d60-b657-b30a14719251/documents/IUC5-c6312749-8556-48d6-a91c-06573d52bc56_d6d81a26-e711-4629-9cbc-4133f9a16bd5.html,,,,,, "4-[(1-butyl-5-cyano-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl)azo]-N-(2-ethylhexyl)benzenesulphonamide",55290-62-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04d01869-6ff3-4d60-b657-b30a14719251/documents/IUC5-c6312749-8556-48d6-a91c-06573d52bc56_d6d81a26-e711-4629-9cbc-4133f9a16bd5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "4-[(1-butyl-5-cyano-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl)azo]-N-(2-ethylhexyl)benzenesulphonamide",55290-62-5,"- Acute oral toxicity: LD50 > 2000 mg/kg bw (Safepharm, 2000)- Acute dermal toxicity: LD50 > 2000 mg/kg (Bioassay, 2014) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04d01869-6ff3-4d60-b657-b30a14719251/documents/IUC5-5eebd8d9-715b-4762-8b01-f06df4cb80ab_d6d81a26-e711-4629-9cbc-4133f9a16bd5.html,,,,,, "4-[(1-butyl-5-cyano-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl)azo]-N-(2-ethylhexyl)benzenesulphonamide",55290-62-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04d01869-6ff3-4d60-b657-b30a14719251/documents/IUC5-5eebd8d9-715b-4762-8b01-f06df4cb80ab_d6d81a26-e711-4629-9cbc-4133f9a16bd5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-[(1-butyl-5-cyano-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl)azo]-N-(2-ethylhexyl)benzenesulphonamide",55290-62-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04d01869-6ff3-4d60-b657-b30a14719251/documents/IUC5-5eebd8d9-715b-4762-8b01-f06df4cb80ab_d6d81a26-e711-4629-9cbc-4133f9a16bd5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide",6410-38-4,"Oral toxicity   The test item and analogous substance, Pigment Red 112, did not cause any mortality or significant clinical signs or necropsy findings after single oral gavage administration to male and female rats at 5000 mg/kg bw in a OECD guideline and GLP compliant study. The LD50 (male/female rat) was greater than 5000 mg/kg body weight.   Inhalation toxicity The test item and close analogue, Pigment Red 188, did not cause any mortality or significant clinical signs or necropsy findings after single acute inhalation (4 hours) of 5.05 mg/L pigment dust in Wistar rats. Therefore, the Median Lethal Concentration (LC50) value of the test item is more than 5.05 mg/L of chamber air.   Dermal toxicity The Test item and analogous substance, Pigment Red 112, did not cause any mortality or significant clinical signs or necropsy findings after single dermal application to male rats at 5000 mg/kg bw in a OECD guideline compliant study. The LD50 (male rat) was greater than 5000 mg/kg body weight. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): valid and reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): reliable and valid Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): valid and reliable ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad0773e9-ca7a-497c-bbe7-62cf95279a8b/documents/fc802c8f-56e7-4eac-9f7b-8bf5fe7f38b2_f9094774-f733-44ef-9aba-6c2c68ab09ba.html,,,,,, "4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide",6410-38-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad0773e9-ca7a-497c-bbe7-62cf95279a8b/documents/fc802c8f-56e7-4eac-9f7b-8bf5fe7f38b2_f9094774-f733-44ef-9aba-6c2c68ab09ba.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide",6410-38-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad0773e9-ca7a-497c-bbe7-62cf95279a8b/documents/fc802c8f-56e7-4eac-9f7b-8bf5fe7f38b2_f9094774-f733-44ef-9aba-6c2c68ab09ba.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide",6410-38-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad0773e9-ca7a-497c-bbe7-62cf95279a8b/documents/fc802c8f-56e7-4eac-9f7b-8bf5fe7f38b2_f9094774-f733-44ef-9aba-6c2c68ab09ba.html,,inhalation,LC50,> 5.05 mg/L,no adverse effect observed, "4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-phenylnaphthalene-2-carboxamide",6041-94-7,"Oral route: PR 112 The toxicity of the test item when given by oral administration (gavage) to groups of 5 rats per sex per dose for 28 consecutive days at dosages of 0, 100, 300 or 1000 mg/kg bw/day, for 7 days/week have been investigated. No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). Red staining of various body parts, red faeces and reddish contents of the gastro-intestinal tract noted among all groups treated with the test substance was considered to be related to staining properties of the test substance, and not to represent signs of systemic toxicity. No correlating histopathological abnormalities were noted. On the basis of these results, the high dose level of 1000 mg/kg/day was considered to be the No Observed Adverse Effect Level (NOAEL) for the test substance. PR022 A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test was performed according to OECD TG 422. The test item was administered to Sprague Dawley rats (12/sex/dose) by gavage at dose levels of 0, 100, 300 and 1000 mg/kg/day for a total of 37 days (males) and through mating, gestation and delivery until day 4 of lactation (females). No toxic effects were observed in this study except increased liver weights in males and females of the highest dose group. As the effects on liver weight were minimal (less than 10% weight changes) and not accompanied by any histopathological or biochemical changes these effects were judged not to be adverse. The no-observed-adverse-effect level (NOAEL) for repeated dose toxicity was 1000 mg/kg under the conditions of this study. There were no effects on reproduction or development. inhalation route:  PR112 The objective of the OECD TG 413 following study was to determine the toxic potential of the close analogue, Pigment Red 112, when administered for 6 hours/day, 5 days per week, for 13 consecutive weeks by flow-past nose-only inhalation route to Sprague Dawley rats. This study provides information on toxic effects, target organs, the possibility of cumulative effects, the reversibility of effects (after 90 and 180 days recovery period), and an estimate of the No Observed Adverse Effects Concentration (NOAEC). Based on the observed results, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item was found to be 30 mg/m³ (0,03 mg/L) after 90 days of exposure (highest concentration tested). The nominal dose of 0.03 mg/L (6 hrs/day, 5 days/week) corresponded to an actual exposure concentration in males and females. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c03c4ba4-23bf-4284-8070-9d8b780bf82e/documents/3b9e19a9-d658-43a9-b1a1-7ee7019a4c5f_36961ec1-42fb-49d6-b653-42ce37071622.html,,,,,, "4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-phenylnaphthalene-2-carboxamide",6041-94-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c03c4ba4-23bf-4284-8070-9d8b780bf82e/documents/3b9e19a9-d658-43a9-b1a1-7ee7019a4c5f_36961ec1-42fb-49d6-b653-42ce37071622.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-phenylnaphthalene-2-carboxamide",6041-94-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c03c4ba4-23bf-4284-8070-9d8b780bf82e/documents/3b9e19a9-d658-43a9-b1a1-7ee7019a4c5f_36961ec1-42fb-49d6-b653-42ce37071622.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,>= 30 mg/m3,,rat "4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-phenylnaphthalene-2-carboxamide",6041-94-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c03c4ba4-23bf-4284-8070-9d8b780bf82e/documents/3b9e19a9-d658-43a9-b1a1-7ee7019a4c5f_36961ec1-42fb-49d6-b653-42ce37071622.html,Repeated dose toxicity – local effects,inhalation,NOAEC,>= 30 mg/m3,no adverse effect observed,rat "4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-phenylnaphthalene-2-carboxamide",6041-94-7,"oral route: Female and male Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage at a dose of 15000 mg/kg bw (25 % suspension in sesame oil). No animal died during the 14 day observation period, resulting in a LD50 >15000 mg/kg bw. dermal route: The Test item (<90% Pigment Red 112) did not cause any mortality or significant clinical signs or necropsy findings after single dermal application to male rats at 5000 mg/kg bw in a OECD guideline compliant study. The LD50 (male rat) was greater than 5000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c03c4ba4-23bf-4284-8070-9d8b780bf82e/documents/df409431-25eb-4406-bff2-b092a45565d0_36961ec1-42fb-49d6-b653-42ce37071622.html,,,,,, "4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-phenylnaphthalene-2-carboxamide",6041-94-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c03c4ba4-23bf-4284-8070-9d8b780bf82e/documents/df409431-25eb-4406-bff2-b092a45565d0_36961ec1-42fb-49d6-b653-42ce37071622.html,,oral,LD50,"> 15,000 mg/kg bw",no adverse effect observed, "4-[(2,5-dichlorophenyl)azo]-3-hydroxy-N-phenylnaphthalene-2-carboxamide",6041-94-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c03c4ba4-23bf-4284-8070-9d8b780bf82e/documents/df409431-25eb-4406-bff2-b092a45565d0_36961ec1-42fb-49d6-b653-42ce37071622.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "4-[(2,5-dichlorophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxynaphthalene-2-carboxamide",6992-11-6," RA from PR176 Under the conditions of the present study, the repeated oral administration of test material to male and female Wistar rats at doses of 100, 300 and 1000 mg/kg body weight for 28 days was associated with no relevant signs of toxicity or mortality. Based on the data generated from this study, the NOAEL (No Observed Adverse Effect Level) of the teat material is considered to be 1000 mg/kg body weight/day (i.h. highest dose tested) for the 28-day repeated dose oral toxicity study in male and female rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/439b577d-2789-42c3-b7ea-aaad13616ed9/documents/06df8973-edc0-48b6-b0ac-bb69db490bd8_563e20c7-5516-48fa-8343-3ffd55ddfe1b.html,,,,,, "4-[(2,5-dichlorophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxynaphthalene-2-carboxamide",6992-11-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/439b577d-2789-42c3-b7ea-aaad13616ed9/documents/06df8973-edc0-48b6-b0ac-bb69db490bd8_563e20c7-5516-48fa-8343-3ffd55ddfe1b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4-[(2,5-dichlorophenyl)azo]-N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxynaphthalene-2-carboxamide",6992-11-6," PB25 Under the conditions of the present study, a single oral application of the test item to female rats at a dose of 2000 mg/kg body weight was associated with no sign of toxicity or mortality. The LD50 for female rats is > 2000 mg/kg body weight Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity nor signs of irritation. The dermal LD50 was determined to be > 2000 mg/ kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/439b577d-2789-42c3-b7ea-aaad13616ed9/documents/5e713fad-be61-4cde-96f8-8329b70e4c57_563e20c7-5516-48fa-8343-3ffd55ddfe1b.html,,,,,, 4-[(2-chloro-4-nitrophenyl)azo]-N-ethyl-N-[2-[1-(2-methylpropoxy)ethoxy]ethyl]aniline,85750-13-6,"Repeated dose toxicity: Oral The no observed adverse effect level (NOAEL) value for repeated dose toxicity of the test chemical in male and female F344 rats is considered to be 1250mg/kg/day. Repeated dose toxicity: Inhalation 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline (CAS no 85750-13-6) has very low vapor pressure of 1.52E-008 Pa, so the potential for the generation of inhalable vapors is very low, also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route of exposure was considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value for 4-((2-Chloro-4-nitrophenyl)azo)-N-ethyl-N-(2-(1-(2-methylpropoxy)ethoxy)ethyl)aniline (CAS no 85750-13-6) is >2000 mg/kg body weight. The substance was also found to be not irritating and not sensitizing to skin. Based on these considerations, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/318afb0c-e66a-498f-b655-ac3d67568848/documents/800bf186-1b36-46fb-aa7a-4fb56ccff95a_62b2c220-743b-42d4-bf9f-5571b0c08a10.html,,,,,, 4-[(2-chloro-4-nitrophenyl)azo]-N-ethyl-N-[2-[1-(2-methylpropoxy)ethoxy]ethyl]aniline,85750-13-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/318afb0c-e66a-498f-b655-ac3d67568848/documents/800bf186-1b36-46fb-aa7a-4fb56ccff95a_62b2c220-743b-42d4-bf9f-5571b0c08a10.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,250 mg/kg bw/day",,rat 4-[(2-chloro-4-nitrophenyl)azo]-N-ethyl-N-[2-[1-(2-methylpropoxy)ethoxy]ethyl]aniline,85750-13-6,"Acute oral toxicity:  Acute oral toxicity study was done in mouse using test chemical. No mortality was observed at dose 10000mg/kg bw. Hence LD50 was considered to be >10000 mg/kg body weight,when mouse was treated with test chemical orally.   Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to low vapour pressure of the test chemical, which is reported to be 1.52E-008 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The LD50 value was considered to be >2000 mg/kg bw, when male and female Sprague Dawley rats were occlusively treated with the given test chemical by dermal application following 14 days of observation period according to OECD Guideline 402 (Acute Dermal Toxicity). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/318afb0c-e66a-498f-b655-ac3d67568848/documents/931099fd-e6ce-47c2-97e6-88ca77e23741_62b2c220-743b-42d4-bf9f-5571b0c08a10.html,,,,,, 4-[(2-chloro-4-nitrophenyl)azo]-N-ethyl-N-[2-[1-(2-methylpropoxy)ethoxy]ethyl]aniline,85750-13-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/318afb0c-e66a-498f-b655-ac3d67568848/documents/931099fd-e6ce-47c2-97e6-88ca77e23741_62b2c220-743b-42d4-bf9f-5571b0c08a10.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, 4-[(2-chloro-4-nitrophenyl)azo]-N-ethyl-N-[2-[1-(2-methylpropoxy)ethoxy]ethyl]aniline,85750-13-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/318afb0c-e66a-498f-b655-ac3d67568848/documents/931099fd-e6ce-47c2-97e6-88ca77e23741_62b2c220-743b-42d4-bf9f-5571b0c08a10.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-[(2E)-3-(3,5-dichloro-4-fluorophenyl)-4,4,4-trifluorobut-2-enoyl]-N-[(4R)-2-ethyl-3-oxo-1,2-oxazolidin-4-yl]-2-methylbenzamide",2475232-73-4," Acute, oral, rat: LD50 >2000 mg/kg bw, OECD TG 425, Zelenak 2018 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d7c2474-67d9-4b89-a3f8-04967b70813e/documents/a1f98467-cef3-4ff7-87b3-ab0d39ffddff_ab53102c-2690-4c72-a863-21e3dce6df5e.html,,,,,, "4-[(2E)-3-(3,5-dichloro-4-fluorophenyl)-4,4,4-trifluorobut-2-enoyl]-N-[(4R)-2-ethyl-3-oxo-1,2-oxazolidin-4-yl]-2-methylbenzamide",2475232-73-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d7c2474-67d9-4b89-a3f8-04967b70813e/documents/a1f98467-cef3-4ff7-87b3-ab0d39ffddff_ab53102c-2690-4c72-a863-21e3dce6df5e.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid",70239-77-9," Repeated dose toxicity: Oral Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid. The study assumed the use of male and female Crj: CD (SD) rats in a study for 28 days. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Level (NOAEL) for 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid is predicted to be 435.833343506 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. Repeated dose toxicity: Inhalation 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid has very low vapor pressure (2.61E-022 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated inhalation toxicity was considered for waiver Repeated dose toxicity: Dermal The acute dermal toxicity value for4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid(as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not irritating and not sensitizing to the skin. Based on these considerations, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a8ed515-4ecf-4159-b4a3-3c504a8c7392/documents/2fd410ca-9ffe-49b5-b48c-4fc9d3e3a73f_59da0aab-ea07-47d4-be9c-0f47b2998a43.html,,,,,, "4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid",70239-77-9,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a8ed515-4ecf-4159-b4a3-3c504a8c7392/documents/2fd410ca-9ffe-49b5-b48c-4fc9d3e3a73f_59da0aab-ea07-47d4-be9c-0f47b2998a43.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,435.833 mg/kg bw/day,,rat "4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid",70239-77-9," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target substance 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid (70239-77-9)was estimated to be 6733.41 mg/kg bw,and for different studies available on the structurally similar read across substance Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (3734-67-6) was considered to be >2000 mg/kg bw and Disodium 5-amino-4-hydroxy-3-(phenylazo) naphthalene-2, 7-disulphonate (CAS No. 3567-66-6) was considered to be 5000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid (70239-77-9)can be classified as category V of acute oral toxicity. Acute inhalation Toxicity:  4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid has very low  vapor pressure (2.61E-022 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal Toxicity: In Acute dermal toxicity, LD50 value was predicted based on OECD QSAR toolbox for target substance 4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid (70239-77-9)was estimated to be 3392.01 mg/kg bw,and for different studies available on structurally similar read across substance Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (3734-67-6) was considered to be >2000 mg/kg bw and Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2, 7-disulphonate (CAS No. 3567-66-6) was considered to be >2000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid (70239-77-9)can be classified as category V of acute dermal toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a8ed515-4ecf-4159-b4a3-3c504a8c7392/documents/0fc7d5d0-4a04-454e-83d5-75619906a920_59da0aab-ea07-47d4-be9c-0f47b2998a43.html,,,,,, "4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid",70239-77-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a8ed515-4ecf-4159-b4a3-3c504a8c7392/documents/0fc7d5d0-4a04-454e-83d5-75619906a920_59da0aab-ea07-47d4-be9c-0f47b2998a43.html,,oral,LD50,"6,733.41 mg/kg bw",no adverse effect observed, "4-[(3-aminobenzoyl)amino]-5-hydroxynaphthalene-1,7-disulphonic acid",70239-77-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a8ed515-4ecf-4159-b4a3-3c504a8c7392/documents/0fc7d5d0-4a04-454e-83d5-75619906a920_59da0aab-ea07-47d4-be9c-0f47b2998a43.html,,dermal,LD50,"3,392.01 mg/kg bw",no adverse effect observed, "4-[(4-ethoxyphenyl)amino]-N,N-dimethyl-3-nitrobenzenesulphonamide",67338-59-4,The oral LD50 of the test substance was found to be > 2000 mg/kg bw in rats (1814 mg/kg based on a.i.) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10989880-2af8-4ae2-bb7d-8dc272c5b3b8/documents/IUC5-4e3220dc-436e-414e-9cb7-f8cca1f9ddb5_d6881003-8636-47d3-8f35-23ef662aacb1.html,,,,,, "4-[(4-ethoxyphenyl)amino]-N,N-dimethyl-3-nitrobenzenesulphonamide",67338-59-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10989880-2af8-4ae2-bb7d-8dc272c5b3b8/documents/IUC5-4e3220dc-436e-414e-9cb7-f8cca1f9ddb5_d6881003-8636-47d3-8f35-23ef662aacb1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-[(4-HYDROXYPYRIMIDIN-2-YL)AMINO]BENZONITRILE,189956-45-4," Repeated dose toxicity - oral: In a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the test substance was administered daily to rats up to a dose level of 1000 mg/kg body weight/day (OECD 422; van Otterdijk, 2017). The NOAEL is established to be at least 1000 mg/kg body weight/day. The substance is therefore not classified as a repeated dose toxicant (STOT RE) according to the CLP Regulation.   Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure.   Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ad929c0-592e-4023-b4a2-6a57aea8cde0/documents/d5d8b2a5-c6b4-47d4-ab08-b4cdc96a5532_bda9767c-52eb-442d-ac1b-3501debc960c.html,,,,,, 4-[(4-HYDROXYPYRIMIDIN-2-YL)AMINO]BENZONITRILE,189956-45-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ad929c0-592e-4023-b4a2-6a57aea8cde0/documents/d5d8b2a5-c6b4-47d4-ab08-b4cdc96a5532_bda9767c-52eb-442d-ac1b-3501debc960c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-[(4-HYDROXYPYRIMIDIN-2-YL)AMINO]BENZONITRILE,189956-45-4," Acute toxicity: Oral: In an acute oral toxicity study in the female outbred albino mouse, following the acute toxic class method in accordance with the OECD Guideline 423, the LD50 was established to be greater than 2000 mg/kg.   Acute toxicity: Inhalation: In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For this substance, a study was considered however not deemed scientifically justified for the dermal route of exposure due to its low potential for a significant  rate of absorption through the skin. Based on the fact that the inhalation route of exposure is not considered relevant in the risk assessment for human exposure and the addition of a waiver for the acute dermal toxicity testing, an acute inhalation toxicity study will not be performed.   Acute toxicity: Dermal: In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For this substance, an acute dermal toxicity study was considered. However, this can be waived based on the fact that the substance does not meet the criteria for classification for acute toxicity or STOT SE by the oral route, and no systemic toxicity is observed in in vivo studies with dermal exposure. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ad929c0-592e-4023-b4a2-6a57aea8cde0/documents/77e408ff-48d9-47c8-aa4e-da0ac738b333_bda9767c-52eb-442d-ac1b-3501debc960c.html,,,,,, 4-[(4-HYDROXYPYRIMIDIN-2-YL)AMINO]BENZONITRILE,189956-45-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ad929c0-592e-4023-b4a2-6a57aea8cde0/documents/77e408ff-48d9-47c8-aa4e-da0ac738b333_bda9767c-52eb-442d-ac1b-3501debc960c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonic acid",12239-15-5," Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for 4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonic acid. The study assumed the use of male and female Sprague Dawley rats in a 28 days toxicity study. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Level (NOAEL) for 4-[(5-amino-3-methyl-1-phenyl-1H- pyrazol-4-yl)azo]-2,5- dichlorobenzenesulphonic acid is predicted to be 942.666687012 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/250a6a85-db28-45bf-88ae-2ee278b1f681/documents/10f3fd2c-e85d-4e90-8005-db73e325350c_7517ac25-ba3d-4c50-b8dc-033b9f615669.html,,,,,, "4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonic acid",12239-15-5,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/250a6a85-db28-45bf-88ae-2ee278b1f681/documents/10f3fd2c-e85d-4e90-8005-db73e325350c_7517ac25-ba3d-4c50-b8dc-033b9f615669.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,942.667 mg/kg bw/day,,rat "4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonic acid",12239-15-5," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target substance 4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonic acid (12239-15-5) was estimated to be 3878.13 mg/kg bw,and for differentstudies available on the structurally similar read across substance 3-methyl-1-phenylpyrazol-5-ylamine(1131-18-6) was considered to be 2500 mg/kg bw and for functionally similar read across substanceBarium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate] (5160-02-1) was considered to be >10000 mg/kg bw.All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonic acid (12239-15-5) cannot be classified for acute oral toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/250a6a85-db28-45bf-88ae-2ee278b1f681/documents/ff2995b6-a99a-47ac-8926-cec9d257275f_7517ac25-ba3d-4c50-b8dc-033b9f615669.html,,,,,, "4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonic acid",12239-15-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/250a6a85-db28-45bf-88ae-2ee278b1f681/documents/ff2995b6-a99a-47ac-8926-cec9d257275f_7517ac25-ba3d-4c50-b8dc-033b9f615669.html,,oral,LD50,"3,878.13 mg/kg bw",no adverse effect observed, 4-[(E)-2-nitroethenyl]-1H-indole,49839-99-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a4f7891-0e93-4f01-a046-232c4791aa65/documents/8890693b-de56-49f1-99ed-9507d69bc462_28909f8a-321c-44f7-8061-95d4a07fbfa6.html,,oral,LD50,"1,000 mg/kg bw",no adverse effect observed, 4-[(morpholinothio)thioxomethyl]morpholine,13752-51-7,A two year chronic feeding study is available. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/87bac2d6-6622-42b8-9b31-f6076574d097/documents/784a84e0-417f-4780-9c2f-0fa217a2add0_12413a77-e34f-4dfa-aa87-f085c120ee0d.html,,,,,, 4-[(morpholinothio)thioxomethyl]morpholine,13752-51-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/87bac2d6-6622-42b8-9b31-f6076574d097/documents/784a84e0-417f-4780-9c2f-0fa217a2add0_12413a77-e34f-4dfa-aa87-f085c120ee0d.html,Chronic toxicity – systemic effects,oral,NOAEL,10.2 mg/kg bw/day,,rat 4-[(morpholinothio)thioxomethyl]morpholine,13752-51-7,"Acute Oral Toxicity:  Two Acute Oral LD50 studies were conducted in rats. The lowest LD50 in these studies was 5000 mg/kg. An acute oral LD50 study was conducted in mice.  The LD50 in this study was 9000 mg/kg.Acute Dermal Toxicity: The acute dermal LD50 for albino rabbits is greater than 10,000 mg/Kg.Acute Inhalation Toxicity: The acute inhalation LC50 (1hr) is greater than 164.4 mg/L. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87bac2d6-6622-42b8-9b31-f6076574d097/documents/67a1b149-7645-4cd8-98de-80954a368f2a_12413a77-e34f-4dfa-aa87-f085c120ee0d.html,,,,,, 4-[(morpholinothio)thioxomethyl]morpholine,13752-51-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87bac2d6-6622-42b8-9b31-f6076574d097/documents/67a1b149-7645-4cd8-98de-80954a368f2a_12413a77-e34f-4dfa-aa87-f085c120ee0d.html,,oral,LD50,"5,000 mg/kg bw",, 4-[(morpholinothio)thioxomethyl]morpholine,13752-51-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87bac2d6-6622-42b8-9b31-f6076574d097/documents/67a1b149-7645-4cd8-98de-80954a368f2a_12413a77-e34f-4dfa-aa87-f085c120ee0d.html,,dermal,discriminating dose,"10,000 mg/kg bw",, 4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]phenol,19800-42-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ed68f11-bba5-4aa2-9b4d-98c2e97702d8/documents/3dec84c2-94c3-49db-a0ae-d68162410696_4a1f3d0a-422f-4a88-ac35-ca043a67e5e2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,94.8 mg/kg bw/day,,rat 4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]phenol,19800-42-1," A study was conducted to determine the acute oral toxicity of the test substance to rats. Female SPF Wistar rats were administered a single dose of the test substance as a liquid dispersion (20% purity) via gavage. Rats were not fed from 16 h pre-test to 2 h post-application. There were 10 rats per group, exposed to nominal concentrations of 1250, 2500, 4000, 6300 and 10000 mg/kg bw (equivalent to 250, 500, 800, 1260 and 2000 mg a.i./L). The animals were then observed during 14 days for mortality and clinical signs. Bodyweights were recorded weekly. Moribund rats were dissected and evaluated macroscopically. The same procedure was carried out for all remaining rats at the end of the study. Directly after gavage, a yellow discoloration of the urine was observed. Moribund animals showed irregular breathing and disturbance of their balance. At test end, no macroscopic lesions were found except for a rusty brown discoloration in the stomach and intestine. Bodyweight data results were not discussed. Under the study conditions, the LC50 was determined to be 4529 mg/kg bw, equivalent to 905 mg a.i./kg bw (Hollander, 1986). In another study, female (Hoe WISKf (SPF71)) rats were administered a single dose of the test substance as a liquid dispersion (48% purity) via gavage. Rats were not fed from 16 h pre-test to 2 h post-application. There were 10 rats per group, exposed to nominal concentrations of 1000, 2000, 2800, 4000, 5000 and 6300 mg/kg bw (equivalent to 480, 960, 1344, 1920, 2400 and 3024 mg a.i./L). The animals were then observed during 14 days for mortality and clinical signs. Bodyweights were recorded weekly. Moribund rats were dissected and evaluated macroscopically. The same procedure was carried out for all remaining rats at the end of the study. Moribund animals showed passivity, hyporeflexia, narrowed eyelids, spasmodic and noisy breathing, swelling of the head ('lion head') and brown discoloured urine and stools. Macroscopic evaluation revealed gastrointestinal tract diffuse red and full with test substance, discolored adrenal gland and yellow colored abdomen and fat tissues. There were no further clinical signs at doses up to 4000 mg/kg bw after 72 h and at 5000 mg/kg bw after 8 days. No macroscopic findings were recorded in surviving animals at test end. Under the study conditions, the LC50 was determined to be 3050 mg/kg bw, equivalent to 1525 mg a.i./kg bw (Mayer, 1982). The acute toxicity of Disperse Orange 29 following dermal administration of a single dose to the rat was investigated according to OECD test guideline 402. For that purpose, a single dose of 2000 mg/kg body weight was administered to a group of 5 male and 5 female animals for 24 hours. After 14 days of observation, all animals were killed and subjected to necropsy examination. No mortality occurred and no signs of toxicity were observed in male or female animals during the observation period. The body weight changes observed during the study were within the expected range for this species and age of animals. No abnormalities either general or at the treated site were found at necropsy in the animals at termination of the study. These results indicate that the test item, Disperse Orange 29, has no toxic effect on the rat following dermal exposure over a 24 hour period at a level of 2000mg/kg body weight. The lack of mortality demonstrates the LD50 to be greater than 2000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ed68f11-bba5-4aa2-9b4d-98c2e97702d8/documents/f5f22c6e-35d4-456d-9d0e-7787a1f632bc_4a1f3d0a-422f-4a88-ac35-ca043a67e5e2.html,,,,,, 4-[[2-methoxy-4-[(4-nitrophenyl)azo]phenyl]azo]phenol,19800-42-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ed68f11-bba5-4aa2-9b4d-98c2e97702d8/documents/f5f22c6e-35d4-456d-9d0e-7787a1f632bc_4a1f3d0a-422f-4a88-ac35-ca043a67e5e2.html,,oral,LD50,905 mg/kg bw,adverse effect observed, 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide,2786-76-7,"The registered substance did not cause adverse effects after sub-acute, oral administration of daily doses including 1000 mg/kg bw./day. A close structural analogue of the registered substance did not cause adverse effects after sub-chronic, daily inhalation exposure (6hx5d/week) to concentrations of up to 30 mg/m³.  ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e037ff59-f041-4aa0-bb4a-0ef1d81b962f/documents/b09fe951-22dd-48f1-b0ee-fa35dc9e9647_67b54353-fa49-42d2-a14d-01ac02d54009.html,,,,,, 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide,2786-76-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e037ff59-f041-4aa0-bb4a-0ef1d81b962f/documents/b09fe951-22dd-48f1-b0ee-fa35dc9e9647_67b54353-fa49-42d2-a14d-01ac02d54009.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide,2786-76-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e037ff59-f041-4aa0-bb4a-0ef1d81b962f/documents/b09fe951-22dd-48f1-b0ee-fa35dc9e9647_67b54353-fa49-42d2-a14d-01ac02d54009.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide,2786-76-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e037ff59-f041-4aa0-bb4a-0ef1d81b962f/documents/b09fe951-22dd-48f1-b0ee-fa35dc9e9647_67b54353-fa49-42d2-a14d-01ac02d54009.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide,2786-76-7,"Single oral application of 15000 mg test substance per kg bw did not cause lethality in female Wistar-rats during the 14 day observation period, resulting in a LD50 > 15000 mg/kg bw. Single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated with neither mortality nor signs of toxicity. The dermal LD50 was determined to be > 2000 mg / kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e037ff59-f041-4aa0-bb4a-0ef1d81b962f/documents/4936d8fe-6079-4819-a6d3-beda5302103b_67b54353-fa49-42d2-a14d-01ac02d54009.html,,,,,, 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide,2786-76-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e037ff59-f041-4aa0-bb4a-0ef1d81b962f/documents/4936d8fe-6079-4819-a6d3-beda5302103b_67b54353-fa49-42d2-a14d-01ac02d54009.html,,oral,LD0,"> 15,000 mg/kg bw",no adverse effect observed, 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide,2786-76-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e037ff59-f041-4aa0-bb4a-0ef1d81b962f/documents/4936d8fe-6079-4819-a6d3-beda5302103b_67b54353-fa49-42d2-a14d-01ac02d54009.html,,dermal,LD0,"> 2,000 mg/kg bw",no adverse effect observed, 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide,2786-76-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e037ff59-f041-4aa0-bb4a-0ef1d81b962f/documents/4936d8fe-6079-4819-a6d3-beda5302103b_67b54353-fa49-42d2-a14d-01ac02d54009.html,,inhalation,LC0,> 1.58 mg/L,no adverse effect observed, 4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxy-N-(3-nitrophenyl)naphthalene-2-carboxamide,6448-96-0," Repeated dose toxicity: Oral   The endpoint for the repeated dose toxicity by oral route was considered to be in a dose range of 1 % (1300 mg/kg/day) -6000 mg/kg/day concentration of  test substace to mice for 12 weeks by oral route . Repeated dose toxicity: inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 3-hydroxy-4-{[2-methoxy-5-(phenylcarbamoyl)phenyl]diazenyl}-N-(3-nitrophenyl)-2-naphthamide (6448-96-0 ) which is reported as 0.0001860153mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical 3-hydroxy-4-{[2-methoxy-5-(phenylcarbamoyl)phenyl] diazenyl}- N-(3-nitrophenyl)-2-naphthamide is highly unlikely. Therefore this study is considered for waiver. Repeated dose toxicity: dermal The acute toxicity value for 3-hydroxy-4-{[2-methoxy-5-(phenylcarbamoyl)phenyl]diazenyl}-N-(3-nitrophenyl)-2-naphthamide (6448-96-0 ) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 3-hydroxy-4-{[2-methoxy-5-(phenylcarbamoyl)phenyl]diazenyl}-N-(3-nitrophenyl)-2-naphthamide shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 4-(2-methylprop-2-en-1-yl) benzenesulfonate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b02cca3c-0f1d-4338-b519-172138cb2304/documents/67b2590e-a0e5-4701-b80b-c2a08a44b15f_cdeefdef-aaac-4ad7-bd02-f558ef08c937.html,,,,,, 4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxy-N-(3-nitrophenyl)naphthalene-2-carboxamide,6448-96-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b02cca3c-0f1d-4338-b519-172138cb2304/documents/67b2590e-a0e5-4701-b80b-c2a08a44b15f_cdeefdef-aaac-4ad7-bd02-f558ef08c937.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,300 mg/kg bw/day",,mouse 4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxy-N-(3-nitrophenyl)naphthalene-2-carboxamide,6448-96-0," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 1.93E-021 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b02cca3c-0f1d-4338-b519-172138cb2304/documents/a3ad2995-4a6e-4fb0-acb9-7250a6cede3a_cdeefdef-aaac-4ad7-bd02-f558ef08c937.html,,,,,, 4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxy-N-(3-nitrophenyl)naphthalene-2-carboxamide,6448-96-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b02cca3c-0f1d-4338-b519-172138cb2304/documents/a3ad2995-4a6e-4fb0-acb9-7250a6cede3a_cdeefdef-aaac-4ad7-bd02-f558ef08c937.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxy-N-(3-nitrophenyl)naphthalene-2-carboxamide,6448-96-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b02cca3c-0f1d-4338-b519-172138cb2304/documents/a3ad2995-4a6e-4fb0-acb9-7250a6cede3a_cdeefdef-aaac-4ad7-bd02-f558ef08c937.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide,56396-10-2,"Key Study: A subacute (28 -day) repeated dose oral (gavage) toxicity study is available.   This study was designed to assess the systemic toxicity of the test substance to the rat when repeatedly administered orally for a period of 28 consecutive days repeated once daily oral administration.   The test substance was administered by oral gavage, once daily, to three groups of five male and five female rats for twenty-eight consecutive days at dosage levels of 15, 150 or 1000 mg/kg/day. The test substance was used as supplied and administered as a suspension in 1% aqueous methyl cellulose + 0.5% Tween 80 at concentrations of 1.5, 15 and 100 mg/ml . In addition, five male and five female rats were held as a concurrent control receiving the vehicle (1% aqueous methyl cellulose + 0.5% Tween 80) alone at the same dose volume (10 ml/kg/ day) .   Bodyweights, food consumption and clinical observations were recorded during the study for all animals. Sensory reactivity, grip strength and motor activity were assessed in Week 4 of the study. Blood samples for clinical investigations were taken prior to termination and all animals were killed and examined macroscopically on Day 29. At the scheduled necropsy selected organ weights were recorded and a wide range of tissues were preserved. Histopathological examination of specified tissues was then undertaken.   The following comments in relation to principal findings during the study are made in summary:   There were no unscheduled deaths and no clinical signs indicative of toxicity (including neurotoxicity) throughout the study.   Overall mean bodyweight gains for treated groups were comparable with controls for females at 1000 mg/kg/day.   Food intake for treated groups was generally comparable with controls.   All treated groups generally showed similar efficiencies of food utilisation, in comparison with controls.   Females receiving 1000 mg/kg/day showed statistically significantly lower mean APTT values compared with controls. Mean PT values for these females and mean PT and APTT values for treated males were comparable with controls. There were no other differences from controls which were considered to be possibly attributable to treatment.   There were no differences in organ weights compared with control that were considered to be attributable to treatment.   Macroscopic examination revealed pink contents of all or parts of the gastrointestinal tract in all rats treated with 1000 mg/kg/day, compared with 0/5 male and female control rats. Pink staining on the tail was observed in 1/5 female rats treated with 1000 mg/kg/day, compared with 0/5 female control rats.   An intense red staining material was seen in the large intestine of some animals receiving 1000 mg/kg/day of the compound. No adverse treatment related changes were detected.   In conclusion, 150 mg/kg/day represents the highest NOEL and 1000 mg/kg/day was the NOAEL on this study.   Supporting Study: 14 -Day Repeated Dose Oral (Gavage) Range-Finding Toxicity Study in the Rat The study was performed to provide information for further repeated dose toxicity studies (OECD 421). The test item was administered to the Wistar Han™:RccHan™:WIST strain rat for a period of fourteen consecutive days at dose levels of 250, 500 and 1000 mg/kg bw/day. A control group was dosed with vehicle alone (Arachis oil BP). Under the conditions of this study administration of the test substance for fourteen consecutive days at dose levels up to 1000 mg/kg bw/day to Wistar Han™: RccHan™:WIST strain rats did not result in any toxicologically significant findings.                           ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0dfe6b6-7a84-4199-a309-9ca40dff7536/documents/de23b0ca-3b26-4990-96ad-50bddeb698e6_b7303276-cbde-43a2-88e5-d14c42042a7b.html,,,,,, 4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide,56396-10-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0dfe6b6-7a84-4199-a309-9ca40dff7536/documents/de23b0ca-3b26-4990-96ad-50bddeb698e6_b7303276-cbde-43a2-88e5-d14c42042a7b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide,56396-10-2,"Acute Oral Toxicity: Introduction. The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD (Crl: CD®(SD) IGSBR) strain rat.   Method. A group of three fasted females was treated with 2000 mg/kg bodyweight. This was followed by a group of three fasted animals of the other sex at the same dose level. The test material was administered orally as a suspension in arachis oil BP. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy examination.   Mortality. There were no deaths.   Clinical Observations. Pink staining of the fur was noted in all animals one to four days after dosing. There were no other signs of systemic toxicity.   Bodyweight. All animals showed expected gains in bodyweight over the study period.   Necropsy. No abnormalities were noted at necropsy.   Conclusion. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl: CD®(SD) IGS BR) strain rat was estimated as being greater than 2500 mg/kg bodyweight. No mortalities were noted in animals treated with 2000 mg/kg bodyweight.   Acute Dermal Toxicity: A study was performed to assess the acute dermal toxicity of the test item to the rat.   A group of 10 rats (5 males and 5 females) received a single topical application of the test substance, formulated at a maximum practical concentration in corn oil, at a dose level of 2000 mg/kg bodyweight, for a duration of 24 hours. All animals were killed and examined macroscopically on Day 15, the end of the observation period.   Clinical signs were confined to dark cerise coloured faeces seen in all animals on Days 3 through 5. No other clinical signs of reaction to treatment were observed during the study.   Very slight dermal irritation (Grade 1 oedema) was observed in 1 male following removal of the dressings, resolving completely by Day 3. A redisual cerise staining from the test material precluded assessment of the erythema in all animals up to Day 11 or 13. In addition localised spots and/or scabbing was noted in 1 female on Day 9 and 10. No dermal irritation was observed in the remaining animals during the study.   Low bodyweight gains were noted in 1 male and 4 females on Day 8 and for 3 females on Day 15. All other animals were considered to have achieved satisfactory bodyweight gains throughout the study.   Macroscopic examination revealed dark cerise staining at the dose site of 2 females. No other abnormalities were recorded at the macroscopic examination at study termination on Day 15.   The acute lethal dermal dose to rats of the test item was demonstrated to be greater than 2000 mg/kg bodyweight.               ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0dfe6b6-7a84-4199-a309-9ca40dff7536/documents/c004c220-4420-41e1-99d6-824145615846_b7303276-cbde-43a2-88e5-d14c42042a7b.html,,,,,, 4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide,56396-10-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0dfe6b6-7a84-4199-a309-9ca40dff7536/documents/c004c220-4420-41e1-99d6-824145615846_b7303276-cbde-43a2-88e5-d14c42042a7b.html,,oral,LD50,"> 2,500 mg/kg bw",no adverse effect observed, 4-[[5-(anilino)carbonyl-2-methoxyphenyl]azo]-3-hydroxynaphthalene-2-carboxamide,56396-10-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0dfe6b6-7a84-4199-a309-9ca40dff7536/documents/c004c220-4420-41e1-99d6-824145615846_b7303276-cbde-43a2-88e5-d14c42042a7b.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4-[[5-[[[4-(aminocarbonyl)phenyl]amino]carbonyl]-2-methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide",59487-23-9,"oral route: The toxicity of a close structural analogue (PR112) when given by oral administration (gavage) to groups of 5 rats per sex per dose for 28 consecutive days at dosages of 0, 100, 300 or 1000 mg/kg bw/day, for 7 days/week have been investigated. No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). Red staining of various body parts, red faeces and reddish contents of the gastro-intestinal tract noted among all groups treated with the test substance was considered to be related to staining properties of the test substance, and not to represent signs of systemic toxicity. No correlating histopathological abnormalities were noted. On the basis of these results, the high dose level of 1000 mg/kg/day was considered to be the No Observed Adverse Effect Level (NOAEL) for the test substance.   A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test was performed according to OECD TG 422. A close structural analogue (PR 022) was administered to Sprague Dawley rats (12/sex/dose) by gavage at dose levels of 0, 100, 300 and 1000 mg/kg/day for a total of 37 days (males) and through mating, gestation and delivery until day 4 of lactation (females). No toxic effects were observed in this study except increased liver weights in males and females of the highest dose group. As the effects on liver weight were minimal (less than 10% weight changes) and not accompanied by any histopathological or biochemical changes these effects were judged not to be adverse. The no-observed-adverse-effect level (NOAEL) for repeated dose toxicity was 1000 mg/kg under the conditions of this study. There were no effects on reproduction or development.   inhalation route: PR112 The objective of the OECD TG 413 following study was to determine the toxic potential of the close analogue, Pigment Red 112, when administered for 6 hours/day, 5 days per week, for 13 consecutive weeks by flow-past nose-only inhalation route to Sprague Dawley rats. This study provides information on toxic effects, target organs, the possibility of cumulative effects, the reversibility of effects (after 90 and 180 days recovery period), and an estimate of the No Observed Adverse Effects Concentration (NOAEC). Based on the observed results, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item was found to be 30 mg/m³ (0,03 mg/L) after 90 days of exposure (highest concentration tested). The nominal dose of 0.03 mg/L (6 hrs/day, 5 days/week) corresponded to an actual exposure concentration in males and females. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d754ebc5-7dd5-48ec-aece-dda46f8af916/documents/7aa92fab-26df-42f5-8170-53142a04d931_a048ec87-5c1a-4ee4-a1b1-391781085eff.html,,,,,, "4-[[5-[[[4-(aminocarbonyl)phenyl]amino]carbonyl]-2-methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide",59487-23-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d754ebc5-7dd5-48ec-aece-dda46f8af916/documents/7aa92fab-26df-42f5-8170-53142a04d931_a048ec87-5c1a-4ee4-a1b1-391781085eff.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4-[[5-[[[4-(aminocarbonyl)phenyl]amino]carbonyl]-2-methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide",59487-23-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d754ebc5-7dd5-48ec-aece-dda46f8af916/documents/7aa92fab-26df-42f5-8170-53142a04d931_a048ec87-5c1a-4ee4-a1b1-391781085eff.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,>= 30 mg/m3,,rat "4-[[5-[[[4-(aminocarbonyl)phenyl]amino]carbonyl]-2-methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide",59487-23-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d754ebc5-7dd5-48ec-aece-dda46f8af916/documents/7aa92fab-26df-42f5-8170-53142a04d931_a048ec87-5c1a-4ee4-a1b1-391781085eff.html,Repeated dose toxicity – local effects,inhalation,NOAEC,>= 30 mg/m3,no adverse effect observed,rat "4-[[5-[[[4-(aminocarbonyl)phenyl]amino]carbonyl]-2-methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide",59487-23-9,Acute oral toxicity:The test item (Pigment Red 112) did not cause any mortality or significant clinical signs or necropsy findings after single oral gavage administration to male and female rats at 5000 mg/kg bw in a OECD guideline and GLP compliant study. The LD50 (male/female rat) was greater than 5000 mg/kg body weight. Acute inhalation toxicity: The mean median Lethal Concentration (LC50) of a close analogue Pigment Red 188 is more than 5.05 mg/L air in an OECD and GLP compliant acute inhalation toxicity study in Wistar rats. Acute dermal toxicity:  The Test item (<90% Pigment Red 112) did not cause any mortality or significant clinical signs or necropsy findings after single dermal application to male rats at 5000 mg/kg bw in a OECD guideline compliant study. The LD50 (male rat) was greater than 5000 mg/kg body weight. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d754ebc5-7dd5-48ec-aece-dda46f8af916/documents/71e79e77-11e6-4a19-a64e-8516dd49d608_a048ec87-5c1a-4ee4-a1b1-391781085eff.html,,,,,, "4-[[5-[[[4-(aminocarbonyl)phenyl]amino]carbonyl]-2-methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide",59487-23-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d754ebc5-7dd5-48ec-aece-dda46f8af916/documents/71e79e77-11e6-4a19-a64e-8516dd49d608_a048ec87-5c1a-4ee4-a1b1-391781085eff.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "4-[[5-[[[4-(aminocarbonyl)phenyl]amino]carbonyl]-2-methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide",59487-23-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d754ebc5-7dd5-48ec-aece-dda46f8af916/documents/71e79e77-11e6-4a19-a64e-8516dd49d608_a048ec87-5c1a-4ee4-a1b1-391781085eff.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "4-[[5-[[[4-(aminocarbonyl)phenyl]amino]carbonyl]-2-methoxyphenyl]azo]-N-(5-chloro-2,4-dimethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide",59487-23-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d754ebc5-7dd5-48ec-aece-dda46f8af916/documents/71e79e77-11e6-4a19-a64e-8516dd49d608_a048ec87-5c1a-4ee4-a1b1-391781085eff.html,,inhalation,LC50,"> 5,050 mg/m3",no adverse effect observed, "4-[[5-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphophenyl]azo]-4,5-dihydro-5-oxo-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid",93858-25-4," Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound 4-[(E)-2-(5-{[(2Z,4E)-6-chloro-4-[(3-sulfophenyl)imino]-1,2,3,4-tetrahydro-1,3,5-triazin-2-ylidene]amino} -2-sulfophenyl) diazen-1-yl]-5-oxo-1- (4-sulfophenyl)- 4,5-dihydro -1H-pyrazole-3-carboxylic acid (93858-25-4). The study assumed the use of male and female Wistar strain in chronic study of 24 months. No significant alterations were noted at the dose level of 757.0mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for compound 4-[(E)-2-(5-{[(2Z,4E)-6-chloro-4-[(3-sulfophenyl)imino]-1,2,3,4-tetrahydro-1,3,5-triazin-2-ylidene]amino} -2-sulfophenyl) diazen-1-yl]-5-oxo-1- (4-sulfophenyl)- 4,5-dihydro -1H-pyrazole-3-carboxylic acid is considered to be 757.0mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c636bb97-3a6a-4b41-9608-710618e32b55/documents/a47f52ae-849c-4a2c-a0d4-ad14beac2b97_9b2d1bef-0204-48ff-b9c6-335c75b99cab.html,,,,,, "4-[[5-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphophenyl]azo]-4,5-dihydro-5-oxo-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid",93858-25-4,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c636bb97-3a6a-4b41-9608-710618e32b55/documents/a47f52ae-849c-4a2c-a0d4-ad14beac2b97_9b2d1bef-0204-48ff-b9c6-335c75b99cab.html,Chronic toxicity – systemic effects,oral,NOAEL,757 mg/kg bw/day,,rat "4-[[5-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphophenyl]azo]-4,5-dihydro-5-oxo-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid",93858-25-4," Acute oral toxicity: Acute oral toxicity dose (LD50) of 4-[(E)-2-(5-{[(2Z,4E)-6-chloro-4-[(3-sulfophenyl)imino]-1,2,3,4-tetrahydro-1,3,5-triazin-2-ylidene]amino}-2-sulfophenyl) diazen-1-yl]-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazole-3-carboxylic acid (CAS no: 93858-25-4) was predicted based on OECD QSAR toolbox 2298 mg/kg bw and different studies available on structurally similar read across substances Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate (1934-21-0) >6250 mg/kg bw; and 4,4'-bis[4,6-bis(anilino)-1,3,5-triazin-2-yl]aminostilbene-2,2'-disulphonic acid (CAS no: 88-38-0)>10000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 4-[(E)-2-(5-{[(2Z,4E)-6-chloro-4-[(3-sulfophenyl)imino] -1,2,3,4-tetrahydro-1,3,5-triazin-2-ylidene] amino}-2-sulfophenyl)diazen-1-yl]-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazole-3-carboxylic acid cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  4-[(E)-2-(5-{[(2Z,4E)-6-chloro-4-[(3-sulfophenyl)imino]-1,2,3,4-tetrahydro-1,3,5-triazin-2-ylidene]amino}-2-sulfophenyl)diazen-1-yl]-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H- pyrazole-3-carboxylic acid (CAS no: 93858-25-4) has very low vapour pressure (8.83E-39 mmHg), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver.   Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for 4-[(E)-2-(5-{[(2Z,4E)-6-chloro-4-[(3-sulfophenyl)imino]-1,2,3,4-tetrahydro-1,3,5-triazin-2-ylidene]amino}-2-sulfophenyl)diazen-1-yl]- 5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazole-3-carboxylic acid (CAS no: 93858-25-4) was predicted based on OECD QSAR toolbox 9466 mg/kg bw and different studies available for the structurally similar read across substances Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. 15790-07-5) >2000 mg/kg bw and 4,4'-bis[4,6-bis(anilino)- 1,3,5-triazin-2-yl]aminostilbene-2,2'-disulphonic acid (CAS no: 88-38-0) >3000 mg/kg bw. All these studies concluded that the LD50 value is>2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 4-[(E)-2-(5-{[(2Z,4E)-6-chloro-4-[(3-sulfophenyl)imino]-1,2,3,4-tetrahydro- 1,3,5-triazin-2-ylidene]amino} -2-sulfophenyl)diazen-1-yl]-5-oxo-1-(4-sulfophenyl)-4,5-dihydro-1H-pyrazole-3-carboxylic acid cannot be classified for acute dermal toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c636bb97-3a6a-4b41-9608-710618e32b55/documents/1fc3552e-dfb2-479a-a591-a3535c28ce7d_9b2d1bef-0204-48ff-b9c6-335c75b99cab.html,,,,,, "4-[[5-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphophenyl]azo]-4,5-dihydro-5-oxo-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid",93858-25-4,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c636bb97-3a6a-4b41-9608-710618e32b55/documents/1fc3552e-dfb2-479a-a591-a3535c28ce7d_9b2d1bef-0204-48ff-b9c6-335c75b99cab.html,,oral,LD50,"2,298 mg/kg bw",no adverse effect observed, "4-[[5-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphophenyl]azo]-4,5-dihydro-5-oxo-1-(4-sulphophenyl)-1H-pyrazole-3-carboxylic acid",93858-25-4,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c636bb97-3a6a-4b41-9608-710618e32b55/documents/1fc3552e-dfb2-479a-a591-a3535c28ce7d_9b2d1bef-0204-48ff-b9c6-335c75b99cab.html,,dermal,LD50,"9,466 mg/kg bw",no adverse effect observed, 4-[2-[4-[benzylmethyl(ethyl)amino]phenyl]vinyl]-1-(2-hydroxyethyl)pyridinium acetate,83950-14-5," In a test according to OECD 422 the substance was administered to male and female Wistar rats at 0, 50, 100 and 250 mg/kg bw (in water) during 14 days of pre-mating and maximum 14 days of mating in both males and females, during the gestation period and up to post-natal day 12 in females. Males were dosed after the mating period until the minimum total dosing period of 28 days were completed. During the period of administration, the animals were observed each day for signs of toxicity, body weight and food consumption were measured. Functional observations were performed for all animals before treatment and in five males and females in the last week of treatment. Hematological, clinical biochemistry and urine investigations were performed on selected males and females from each group. Blood samples from the adult males were assessed for serum levels for thyroid hormones (T4). After 14 days of treatment, animals were mated (1:1) for a maximum of 14 days. The males were sacrificed after completion of the mating period on treatment day 29 and the females were sacrificed on post natal day 13. A full histopathological evaluation of the preserved tissues was performed on high dose and control animals and dead animals. These examinations were not extended to animals of all other dosage groups as treatment-related changes were not observed in any organ/tissues of the high dose group. For the testes, a detailed qualitative examination was made; taking into account the tubular stages of the spermatogenic cycle at evaluation of additional hematoxylin-PAS (Periodic Acid Schiff) stained slides. All gross lesions macroscopically identified were examined microscopically in all animals. No mortality occurred in the male control or any of the male dose groups during the treatment period of the study. Four female animals died during the treatment period most likely due to gavage errors. Clinical signs that could be related to treatment include increased salivation, discoloration of the faeces, diarrhea and abnormal breathing. In males and females, no relevant effects were observed in any of the parameters of the functional observation battery before and at the end of the treatment period when compared with the controls. In addition there were no effects on body weight and food consumption. Effects on blood were limited to a decreased aPTT in high dosed males. Clinical biochemistry findings included a significant decrease of ASAT in females at 50 and 250 mg/kg bw, that was within historical control data. Parameters measured during urine analysis were within normal ranges. In survivors there were no treatment related macroscopic effects. Liver weights in females at 100 and 250 mg/kg bw were significantly increased but there were no histopathological findings in these livers. In absence of a clear dose response this effect was considered not related to treatment. Other effects on organ weights were considered incidental and not related to treatment. There were no gross lesions or histological findings that could be attributed to treatment with the substance. There were no histological findings on reproductive organs that distinguished controls from test item-treated animals. The NOAEL of the substance in this study for general toxicity is considered to be 250 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85d8ebee-788e-4b84-abd2-c9f872fe54b7/documents/41eb7f73-956a-41ac-8c66-5818a831689b_2f1fe871-ee46-4a2d-bb23-f29f69be2f54.html,,,,,, 4-[2-[4-[benzylmethyl(ethyl)amino]phenyl]vinyl]-1-(2-hydroxyethyl)pyridinium acetate,83950-14-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85d8ebee-788e-4b84-abd2-c9f872fe54b7/documents/41eb7f73-956a-41ac-8c66-5818a831689b_2f1fe871-ee46-4a2d-bb23-f29f69be2f54.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 4-[2-[4-[benzylmethyl(ethyl)amino]phenyl]vinyl]-1-(2-hydroxyethyl)pyridinium acetate,83950-14-5," Rats (5/sex/dose) received a single dose of the substance by gavage ( 0.31, 1.0, 1.25, 1.6, 2.5 and  5.0 mL/kg). Mortality (within 4 hours after dosing) was 0, 0, 3, 4 ,9 and 10 at 0.31, 1.0, 1.25, 1.6, 2.5 and  5.0 mL/kg. During the 14 day observation period diarrhea, nausea, sedation and convulsions were observed in surviving animals. Necropsy of decedents was not possible due to orange discoloration of the organs. In survivors no abnormalities were recorded. The LD50 (as assessed by the author of the report) is 1700 mg/kg bw. No correction for purity was made as the composition of the tested substance is similar to that of the substance subject to registration (Bayer 1981) In an acute dermal toxicity study (limit test) the LD50 of the substance is > 2000 mg/kg bw (Eurofins 2017). No signs of toxicity were observed. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85d8ebee-788e-4b84-abd2-c9f872fe54b7/documents/f3ec4355-fdf1-432b-848c-df36bae6cd6b_2f1fe871-ee46-4a2d-bb23-f29f69be2f54.html,,,,,, 4-[2-[4-[benzylmethyl(ethyl)amino]phenyl]vinyl]-1-(2-hydroxyethyl)pyridinium acetate,83950-14-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85d8ebee-788e-4b84-abd2-c9f872fe54b7/documents/f3ec4355-fdf1-432b-848c-df36bae6cd6b_2f1fe871-ee46-4a2d-bb23-f29f69be2f54.html,,oral,LD50,"1,700 mg/kg bw",adverse effect observed, 4-[2-[4-[benzylmethyl(ethyl)amino]phenyl]vinyl]-1-(2-hydroxyethyl)pyridinium acetate,83950-14-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85d8ebee-788e-4b84-abd2-c9f872fe54b7/documents/f3ec4355-fdf1-432b-848c-df36bae6cd6b_2f1fe871-ee46-4a2d-bb23-f29f69be2f54.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-[3-(1-naphthylamino)propyl]morpholine,5235-82-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): good ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc29cd35-e09f-44cb-869a-75011220608a/documents/acbb96ca-56d9-4cdd-b481-5e9c519de68b_a1e68788-a162-4e06-a47a-1744b2b63018.html,,,,,, 4-[3-(1-naphthylamino)propyl]morpholine,5235-82-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc29cd35-e09f-44cb-869a-75011220608a/documents/acbb96ca-56d9-4cdd-b481-5e9c519de68b_a1e68788-a162-4e06-a47a-1744b2b63018.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 4-[3-(1-naphthylamino)propyl]morpholine,5235-82-5, A single acute oral toxicity study (rats) is available for the registered substance. Acute oral and dermal toxicity studies are also available for the commercial product containing the registered substance (ca. 28%). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc29cd35-e09f-44cb-869a-75011220608a/documents/IUC5-d7cb0a52-bacb-4e3b-80cc-e0b6c6f0bfd8_a1e68788-a162-4e06-a47a-1744b2b63018.html,,,,,, 4-[3-(1-naphthylamino)propyl]morpholine,5235-82-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc29cd35-e09f-44cb-869a-75011220608a/documents/IUC5-d7cb0a52-bacb-4e3b-80cc-e0b6c6f0bfd8_a1e68788-a162-4e06-a47a-1744b2b63018.html,,oral,LD50,"3,110 mg/kg bw",no adverse effect observed, "4-[3-(4-chlorophenyl)-4,5-dihydro-1H-pyrazol-1-yl]benzenesulphonamide",2744-49-2, LD50 (male and female) > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b4169d0-14b2-4b82-9a6c-2b9811b66928/documents/668348be-7117-4bf0-b96e-0a9d8ea57fa2_984073a8-287b-46dd-a90b-61b35a0150f6.html,,,,,, "4-[4-(3,4-Difluorophenyl)-cyclohexyl]-cyclohexanone",167948-98-3, The acute toxicity of the test item was determined in a GLP-study according to OECD Test Guideline 423 as LD50 > 2000 mg/kg bw (reference 7.2.1 -1). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/096f8b8e-3124-423c-a094-db64a4354dfa/documents/99170374-dcf8-4674-976e-68f6bc12766a_fe69223d-18a7-401c-b31a-98e0a6df138d.html,,,,,, "4-[4-(3,4-Difluorophenyl)-cyclohexyl]-cyclohexanone",167948-98-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/096f8b8e-3124-423c-a094-db64a4354dfa/documents/99170374-dcf8-4674-976e-68f6bc12766a_fe69223d-18a7-401c-b31a-98e0a6df138d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4-[4-(4-acryloyloxybutoxycarbonyl)-cyclohexylcarboxy]-benzoic acid 4-[2-[4-[2-[4-[2-[4-[2-[4-[4-[4-(4-acryloyloxybutoxycarbonyl)-cyclohexylcarboxy]-benzoyloxy]-4'-pentyl-[1,1']-bicyclohexyl-4-yl]-ethynyl]-phenyl]-ethynyl]-phenyl]-ethynyl]-phenyl]-ethynyl",1296134-40-1, GLP compliant OECD 423: LD50 (oral) > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d37fedea-0dd9-4967-9587-ba421904e776/documents/80b2b4fa-21b6-4641-a558-118ff1784bbd_9ced147e-9d9c-41ba-b317-edd66363d287.html,,,,,, "4-[4-(4-acryloyloxybutoxycarbonyl)-cyclohexylcarboxy]-benzoic acid 4-[2-[4-[2-[4-[2-[4-[2-[4-[4-[4-(4-acryloyloxybutoxycarbonyl)-cyclohexylcarboxy]-benzoyloxy]-4'-pentyl-[1,1']-bicyclohexyl-4-yl]-ethynyl]-phenyl]-ethynyl]-phenyl]-ethynyl]-phenyl]-ethynyl",1296134-40-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d37fedea-0dd9-4967-9587-ba421904e776/documents/80b2b4fa-21b6-4641-a558-118ff1784bbd_9ced147e-9d9c-41ba-b317-edd66363d287.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,1'-Biphenyl, 4-[difluoro(3,4,5-trifluorophenoxy)methyl]-3,5-difluoro-4'-propyl-",303186-20-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b76c26ca-7f4e-4380-9fd8-8bd1bb90791e/documents/6c6599df-4bf7-4482-a96b-e7e11737ff5b_660f7547-f452-480d-8a78-3f40c25e46fd.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,5 mg/kg bw/day,,rat "1,1'-Biphenyl, 4-[difluoro(3,4,5-trifluorophenoxy)methyl]-3,5-difluoro-4'-propyl-",303186-20-1," The acute toxicity of the test item/read across was investigated in an acute toxicity study on rats. The test animals showed no clinical signs (and no mortality) up to the limit dose after oral administration. Hence, the LD50 is above 2000 mg/Kg bw. The subsequent evaluation on the necessity of a acute test via a second route was done in accordance with Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance, Version 6.0, July 2017, p 374f. A DermWin calculation shows a dermally absorbed dose of 2.3*10 -9 to 1.6*10 -7 mg/cm2/event. Based on the very low dermally absorbed rate and the absence of systemic effects after acute oral administration, a study on acute dermal toxicity is not required. Furthermore, based on the lack of systemic toxicity after acute oral adminsitration, it is more than evident that an acute study on inhalation would not show any different outcome. Therefore, and due to animal welfare reasons a study on acute inhalation is not required. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b76c26ca-7f4e-4380-9fd8-8bd1bb90791e/documents/8fa1cd79-f81b-465d-af61-247676541a9c_660f7547-f452-480d-8a78-3f40c25e46fd.html,,,,,, "1,1'-Biphenyl, 4-[difluoro(3,4,5-trifluorophenoxy)methyl]-3,5-difluoro-4'-propyl-",303186-20-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b76c26ca-7f4e-4380-9fd8-8bd1bb90791e/documents/8fa1cd79-f81b-465d-af61-247676541a9c_660f7547-f452-480d-8a78-3f40c25e46fd.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-{4-[difluoro(3,4,5-trifluorophenoxy)methyl]-3,5-difluorophenyl}-3-fluoro-4'-propyl-1,1'-biphenyl",303186-36-9,"With the test material XXXX one oral and one dermal acute toxicity study were conducted. Both studies showed no mortality, no body weight change and no signs of toxicity. No acute toxicity studies for inhalative administration are available. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c11f12c0-b431-4c10-8eed-80f3b2adf493/documents/IUC5-895a1263-19ed-4992-9c52-0934a97cf1f8_22080acd-65dc-4d32-a102-c3996b116ce0.html,,,,,, "4-[trans-4-(trans-4-butylcyclohexyl)-cyclohexyl]-1-ethoxy-2, 3-difluorobenzene",473257-15-7, Read Across: LD50 > 2000 mg/kg bw ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1d67869-9896-4eb5-9c31-b06353450649/documents/c603fb59-57d5-437f-887a-796eb800d84b_45a58c0f-92c5-4363-8a0e-8ede36c0df58.html,,,,,, "4-[trans-4-(trans-4-butylcyclohexyl)-cyclohexyl]-1-ethoxy-2, 3-difluorobenzene",473257-15-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1d67869-9896-4eb5-9c31-b06353450649/documents/c603fb59-57d5-437f-887a-796eb800d84b_45a58c0f-92c5-4363-8a0e-8ede36c0df58.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, 4-chloro-2-[2-[4,5-dihydro-3-methyl-5-oxo-1-(3-sulfophenyl)-1H-pyrazol-4-yl]diazenyl]-5-methyl-, ammonium salt (1:2",154946-66-4," A seven day study (dose-range finder) and a 28d study in rats (EU B.7, OECD 407, GLP) were performed to evaluate the subacute repeated dose toxicity of the test substance. The test substance did not induce any mortalities, abnormalities or clinical symptoms. Based on the results of these studies, the NOEL and the NOAEL of the test substance is 1000 mg/kg bw per day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a00b8c5-2fc2-47ef-8c3f-c70e0b4254ee/documents/1d00ee4d-6d41-48fc-870a-933683dfdced_6aa16b84-f89d-41d4-8b8e-541dbcedc826.html,,,,,, "Benzenesulfonic acid, 4-chloro-2-[2-[4,5-dihydro-3-methyl-5-oxo-1-(3-sulfophenyl)-1H-pyrazol-4-yl]diazenyl]-5-methyl-, ammonium salt (1:2",154946-66-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a00b8c5-2fc2-47ef-8c3f-c70e0b4254ee/documents/1d00ee4d-6d41-48fc-870a-933683dfdced_6aa16b84-f89d-41d4-8b8e-541dbcedc826.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Benzenesulfonic acid, 4-chloro-2-[2-[4,5-dihydro-3-methyl-5-oxo-1-(3-sulfophenyl)-1H-pyrazol-4-yl]diazenyl]-5-methyl-, ammonium salt (1:2",154946-66-4," In an oral acute toxicity study (GLP) according to EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure), no mortality or adverse treatment-related effects were observed in male and female rats. The median lethal oral dose to rats was found to be greater than 2000 mg/kg bodyweight. In a dermal acute toxicity study (GLP) according to EU Method B.3 (Acute Toxicity (Dermal)), no mortality or adverse treatment-related effects were observed in male and female rats. No irritation or other dermal changes were observed. The median lethal dermal dose to rats was found to be greater than 2000 mg/kg bodyweight. Experimental data of a read across substance are used to evaluate the acute inhalative toxicity of the test substance. A single administration of the analogue substance via respiratory system did not cause health effects or mortalities in rats. The LC50 is > 5.5 mg/L air. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a00b8c5-2fc2-47ef-8c3f-c70e0b4254ee/documents/9d2330d5-8c6f-4eee-b96e-5701d184381c_6aa16b84-f89d-41d4-8b8e-541dbcedc826.html,,,,,, "Benzenesulfonic acid, 4-chloro-2-[2-[4,5-dihydro-3-methyl-5-oxo-1-(3-sulfophenyl)-1H-pyrazol-4-yl]diazenyl]-5-methyl-, ammonium salt (1:2",154946-66-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a00b8c5-2fc2-47ef-8c3f-c70e0b4254ee/documents/9d2330d5-8c6f-4eee-b96e-5701d184381c_6aa16b84-f89d-41d4-8b8e-541dbcedc826.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, 4-chloro-2-[2-[4,5-dihydro-3-methyl-5-oxo-1-(3-sulfophenyl)-1H-pyrazol-4-yl]diazenyl]-5-methyl-, ammonium salt (1:2",154946-66-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a00b8c5-2fc2-47ef-8c3f-c70e0b4254ee/documents/9d2330d5-8c6f-4eee-b96e-5701d184381c_6aa16b84-f89d-41d4-8b8e-541dbcedc826.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, 4-chloro-2-[2-[4,5-dihydro-3-methyl-5-oxo-1-(3-sulfophenyl)-1H-pyrazol-4-yl]diazenyl]-5-methyl-, ammonium salt (1:2",154946-66-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a00b8c5-2fc2-47ef-8c3f-c70e0b4254ee/documents/9d2330d5-8c6f-4eee-b96e-5701d184381c_6aa16b84-f89d-41d4-8b8e-541dbcedc826.html,,inhalation,discriminating conc.,"5,500 mg/m3",no adverse effect observed, 4-acetamido-5-(ethylsulphonyl)-2-methoxybenzoic acid,94134-06-2," The substance is predicted to have a LD50 of ca. 2231 mg/kg bw. However, the prediction is deemed to be reliable with restrictions as the substance could be out of the applicability domain of the model. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6b21bcd-7f91-4f95-b448-d5abc27fb8b0/documents/72fba527-3e63-4540-8711-2a64aea5df22_64154998-4bdc-4caa-bd15-57fd1b2b4401.html,,,,,, 4-acetamido-5-(ethylsulphonyl)-2-methoxybenzoic acid,94134-06-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6b21bcd-7f91-4f95-b448-d5abc27fb8b0/documents/72fba527-3e63-4540-8711-2a64aea5df22_64154998-4bdc-4caa-bd15-57fd1b2b4401.html,,oral,LD50,"2,231 mg/kg bw",, "4-acetamido-5-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]anthranilic acid, sodium salt",94158-82-4," Acute oral toxicity LD50 was estimated to be 26453.31mg/kg bw ,when  female wistar rats were exposed with 2-amino-4-acetamido-5-[(E)-2-(4-{[2-(sulfooxy)ethane]sulfonyl}phenyl)diazen-1-yl]benzoic acid sodium (94158-82-4) orally. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a37a27cd-40b1-42d9-882c-b3940d0fd384/documents/5318fff9-fda4-4691-99b4-3b2d2e553e6f_4e1fdaf2-a620-4bdd-be36-1be7a3b6e089.html,,,,,, "4-acetamido-5-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]anthranilic acid, sodium salt",94158-82-4,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a37a27cd-40b1-42d9-882c-b3940d0fd384/documents/5318fff9-fda4-4691-99b4-3b2d2e553e6f_4e1fdaf2-a620-4bdd-be36-1be7a3b6e089.html,,oral,LD50,"26,453.31 mg/kg bw",no adverse effect observed, 4-acetylmorpholine,1696-20-4,NOAEL systemic parental toxicity: 250 mg/kg bw/dNOAEL reproduction toxicity: 250 mg/kg bw/dNOAEL developmental toxicity: 250 mg/kg bw/d ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0c90a31-aa22-4ae9-b691-2a7ced9cfd2d/documents/IUC5-6a99886b-a596-4c74-b8bf-0adb25c8af8b_4bf301ba-5e01-4297-acde-e67e11101612.html,,,,,, 4-acetylmorpholine,1696-20-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0c90a31-aa22-4ae9-b691-2a7ced9cfd2d/documents/IUC5-6a99886b-a596-4c74-b8bf-0adb25c8af8b_4bf301ba-5e01-4297-acde-e67e11101612.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 4-acetylmorpholine,1696-20-4,The oral LD50 value of the test item in rats is >7136 mg/kg bw (calculated by density from >6400 mm³/kg bw).An 8h inhalation exposure of rats to an atmosphere enriched with the test item caused no deaths. The LC50 was >0.125 mg/L and was calculated from the vapour pressure of acetylmorpholine (0.022 hPa at 20°C).The acute dermal LD50 of the initiated study is >2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0c90a31-aa22-4ae9-b691-2a7ced9cfd2d/documents/IUC5-87013273-b1f4-489f-904b-3c2f0f54596b_4bf301ba-5e01-4297-acde-e67e11101612.html,,,,,, 4-acetylmorpholine,1696-20-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0c90a31-aa22-4ae9-b691-2a7ced9cfd2d/documents/IUC5-87013273-b1f4-489f-904b-3c2f0f54596b_4bf301ba-5e01-4297-acde-e67e11101612.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 4-acetylmorpholine,1696-20-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0c90a31-aa22-4ae9-b691-2a7ced9cfd2d/documents/IUC5-87013273-b1f4-489f-904b-3c2f0f54596b_4bf301ba-5e01-4297-acde-e67e11101612.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 4-acetylmorpholine,1696-20-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0c90a31-aa22-4ae9-b691-2a7ced9cfd2d/documents/IUC5-87013273-b1f4-489f-904b-3c2f0f54596b_4bf301ba-5e01-4297-acde-e67e11101612.html,,inhalation,discriminating conc.,125 mg/m3,no adverse effect observed, 4-Amino-2-fluoro-benzamide,609783-45-1,"No experimental data on acute toxicity of 4-Amino-2-fluorobenzamide is available. Predictions by T.E.S.T. (August 2021) indicate a acute oral LD50 below 2000 mg/kg which would result in classification Cat. 4 (H302) according to Reg. 1272/2008, CLP. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c5994d2-3c9c-49b5-bd38-155e05417b34/documents/58c111d1-5049-4681-868c-c07c8cbaebb5_ff1fd768-65d3-40eb-8196-d36ca6c99431.html,,,,,, 4-amino-2-methylquinoline,6628-04-2,"Acute toxicity: Via oral route: Key study: test method according to OECD 420 and EU Method B.1. In the preliminary study, the animal treated at 300 mg/kg bw presented signs of toxicity and died. In the main study, no toxicity signs were stated at 50 mg/kg. The test substance is classified as Category III according to OECD GHS criteria. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/669c9a36-31ab-45c2-91f1-5cfa4be7568c/documents/IUC5-7aec1a1d-5dbb-41c9-a463-7e6654772d9c_b04fe5c9-ea06-4a73-ba68-1d22a664c230.html,,,,,, 4-amino-2-methylquinoline,6628-04-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/669c9a36-31ab-45c2-91f1-5cfa4be7568c/documents/IUC5-7aec1a1d-5dbb-41c9-a463-7e6654772d9c_b04fe5c9-ea06-4a73-ba68-1d22a664c230.html,,oral,LD50,50 mg/kg bw,adverse effect observed, "4-amino-3,6-bis[[4-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphophenyl]azo]-5-hydroxynaphthalene-2,7-disulphonic acid",51357-74-5," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target substance 4-amino-3,6-bis[(E)-2-[4-({4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl}amino)-2-sulfophenyl]diazen-1-yl]-5-hydroxynaphthalene -2,7-disulfonic acid (51357-74-5) was estimated to be 4514.2 mg/kg bw,and for different studies available on the structurally similar read across substance 5-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonic acid (6522-86-7) was considered to be 7460 mg/kg bw and for 1-Amino-4-(2'-(4'',6''-dichloro-s-triazin-2-yl)amino)phenylamino)9,10-dihydro-9,10-dioxoanthracene-2,4'-disulphonic acid (13324-20-4) was considered to be 8980 mg/kg bw.All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 4-amino-3,6-bis[(E)-2-[4-({4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl}amino)-2-sulfophenyl]diazen-1-yl]-5-hydroxynaphthalene -2,7-disulfonic acid (51357-74-5) cannot be classified for acute oral toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f70ac58-58b2-4c50-967e-e4aaf888e2f1/documents/829aede9-569c-4980-8342-2cee2ab3ec4f_f4d36d4d-f431-4c74-9d9c-de517ab92192.html,,,,,, "4-amino-3,6-bis[[4-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphophenyl]azo]-5-hydroxynaphthalene-2,7-disulphonic acid",51357-74-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f70ac58-58b2-4c50-967e-e4aaf888e2f1/documents/829aede9-569c-4980-8342-2cee2ab3ec4f_f4d36d4d-f431-4c74-9d9c-de517ab92192.html,,oral,LD50,"4,514.2 mg/kg bw",no adverse effect observed, "4-amino-5-hydroxynaphthalene-1,7-disulphonic acid",130-23-4,"LD50 was estimated to be 2084.494628906 mg/kg bw when in Wistar male and female rats were treated with 4-amino-5-hydroxynaphthalene-1,7-disulphonic acid orally. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ddbbbb58-fc59-461b-8844-672215aa6ab1/documents/IUC5-b8a8a58f-5631-4c6f-ae6d-7ef73f561371_728f262a-70d8-4f4e-9ff1-f94361e7c7b1.html,,,,,, "4-amino-5-hydroxynaphthalene-1,7-disulphonic acid",130-23-4,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ddbbbb58-fc59-461b-8844-672215aa6ab1/documents/IUC5-b8a8a58f-5631-4c6f-ae6d-7ef73f561371_728f262a-70d8-4f4e-9ff1-f94361e7c7b1.html,,oral,LD50,"2,084.495 mg/kg bw",no adverse effect observed, "4-aminoazobenzene-3,4'-disulphonic acid",101-50-8,"The No Observed Adverse Effect Level (NOAEL) for the test compound 4-aminoazobenzene-3,4'-disulphonic acid is found to be 792.237976074 mg/Kg bw (actual dose ingested) using rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0e6b19d-73d1-4a51-b583-9e68deaf6b28/documents/IUC5-995110b0-fa34-48ef-84bd-7828024f0ed9_69954879-fb58-4e65-a34c-5a79d3232b6c.html,,,,,, "4-aminoazobenzene-3,4'-disulphonic acid",101-50-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0e6b19d-73d1-4a51-b583-9e68deaf6b28/documents/IUC5-995110b0-fa34-48ef-84bd-7828024f0ed9_69954879-fb58-4e65-a34c-5a79d3232b6c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,792.238 mg/kg bw/day,,rat "4-aminoazobenzene-3,4'-disulphonic acid",101-50-8,"LD50 was estimated to be 5375.854492188 mg/kg bw when rats were treated with 4-aminoazobenzene-3, 4'-disulphonic acid. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0e6b19d-73d1-4a51-b583-9e68deaf6b28/documents/IUC5-0c965128-2a58-4f8b-9061-30456dd04f80_69954879-fb58-4e65-a34c-5a79d3232b6c.html,,,,,, "4-aminoazobenzene-3,4'-disulphonic acid",101-50-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0e6b19d-73d1-4a51-b583-9e68deaf6b28/documents/IUC5-0c965128-2a58-4f8b-9061-30456dd04f80_69954879-fb58-4e65-a34c-5a79d3232b6c.html,,oral,LD50,"5,375.854 mg/kg bw",no adverse effect observed, 4'-aminoazobenzene-4-sulphonic acid,104-23-4," Repeated dose toxicity: Oral The no observed adverse effect level (NOAEL) value of the test chemical is considered to be 142.85 mg/Kg/day as no adverse effects were observed at this dose level. Repeated dose toxicity: Inhalation 4'-aminoazobenzene-4-sulphonic acid (CAS no 104-23-4) has very low vapor pressure (1.41011576258983e-11 mmHg at 25˚C), so the potential for the generation of inhalable vapours is very low. The particle size distribution was determined to be in the range of 75 micrometer to 500 micrometer. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver Repeated dose toxicity: Dermal The acute toxicity value for 4'-aminoazobenzene-4-sulphonic acid (as provided in section 7.2.3) is 5823.333 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 4'-aminoazobenzene-4-sulphonic acid shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 4'-aminoazobenzene-4-sulphonic acid shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/222a0828-77c8-43d3-b246-8707081b06a5/documents/52a9901f-f49d-4809-bb2c-9d6f8c9323b5_c716336a-004b-49cd-92c2-116f0cae32ec.html,,,,,, 4'-aminoazobenzene-4-sulphonic acid,104-23-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/222a0828-77c8-43d3-b246-8707081b06a5/documents/52a9901f-f49d-4809-bb2c-9d6f8c9323b5_c716336a-004b-49cd-92c2-116f0cae32ec.html,Chronic toxicity – systemic effects,oral,NOAEL,142.85 mg/kg bw/day,,rat 4'-aminoazobenzene-4-sulphonic acid,104-23-4," Acute oral toxicity:    The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is between the range 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical is classified in category 4 for acute oral toxicity.   Acute Inhalation Toxicity:   The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 1.88E-9 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity:   The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/222a0828-77c8-43d3-b246-8707081b06a5/documents/5b73e4ba-ee6e-4179-bad5-873bd97b0faa_c716336a-004b-49cd-92c2-116f0cae32ec.html,,,,,, 4'-aminoazobenzene-4-sulphonic acid,104-23-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/222a0828-77c8-43d3-b246-8707081b06a5/documents/5b73e4ba-ee6e-4179-bad5-873bd97b0faa_c716336a-004b-49cd-92c2-116f0cae32ec.html,,oral,LD50,490 mg/kg bw,, 4'-aminoazobenzene-4-sulphonic acid,104-23-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/222a0828-77c8-43d3-b246-8707081b06a5/documents/5b73e4ba-ee6e-4179-bad5-873bd97b0faa_c716336a-004b-49cd-92c2-116f0cae32ec.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, 4-amino-N-(2-ethylhexyl)benzenesulphonamide,53817-09-7,Acute oral toxicity: LD50 > 4640 mg/kg bwAcute inhalation toxicity: LD50 > 1.16 mg/L (maximum attainable dust concentration) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72b4d4ae-e4e7-4c53-bca7-1124da1e1ea8/documents/IUC5-475e1e5b-4595-439a-87d6-a2b812a24855_5e7b5a20-b978-42d4-ba39-177d95560584.html,,,,,, 4-amino-N-(2-ethylhexyl)benzenesulphonamide,53817-09-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72b4d4ae-e4e7-4c53-bca7-1124da1e1ea8/documents/IUC5-475e1e5b-4595-439a-87d6-a2b812a24855_5e7b5a20-b978-42d4-ba39-177d95560584.html,,oral,discriminating dose,"4,640 mg/kg bw",no adverse effect observed, 4-amino-N-(2-ethylhexyl)benzenesulphonamide,53817-09-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72b4d4ae-e4e7-4c53-bca7-1124da1e1ea8/documents/IUC5-475e1e5b-4595-439a-87d6-a2b812a24855_5e7b5a20-b978-42d4-ba39-177d95560584.html,,inhalation,discriminating conc.,"1,160 mg/m3",no adverse effect observed, 4-amino-N-(4-aminophenyl)benzenesulphonamide,16803-97-7," Acute oral toxicity:  Acute oral toxicity dose (LD50) for 4-amino-N-(4-aminophenyl)benzenesulphonamide (16803-97-7) was determined by Sustainability Support Services (Europe) AB and the acute oral LD50 was calculated as 7100 (5504-9159) mg/kg bw. It was concluded that LD50 value is greater than 2000 mg/kg bw.Thus, acute toxicity study of 4-amino-N-(4-aminophenyl) benzenesulphonamide, when administered to Sprague-Dawley male and female rats falls into the “Category 5 (>2000)” as per criteria of CLP. Acute Inhalation toxicity:  Acute Inhalation toxicity dose (LC50) for 4-amino-N-(4-aminophenyl)benzenesulphonamide (16803-97-7) was determined by Sustainability Support Services (Europe) AB and the acute inhalation LC50 was calculated as >5.2 mg/L air. It was concluded that LC50 value is greater than 5 mg/L air.Thus, acute toxicity study of 4-amino-N-(4-aminophenyl) benzenesulphonamide, when treated in Wistar male/femaleratsfor 4 hoursfalls into the “Category 5” as per criteria of CLP. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for 4-amino-N-(4-aminophenyl)benzenesulphonamide (16803-97-7) was predicted based on OECD QSAR toolbox 4506 mg/kg bwand differentstudies available on structurally similar read across substance6-aminonaphthalene-2-sulphonic acid (CAS No. 93-00-5)>2000 mg/kg bw and 4,4'-Diamino diphenyl sulfone (80-08-0) >4000 mg/kg bw.All these studies concluded that the LD50 value is>2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 4-amino-N-(4-aminophenyl)benzenesulphonamide can be classified as category V of acute dermal toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e531a76b-8bc3-4e0b-88b0-f6d611028c6f/documents/64b7080b-a583-4375-b83f-a95ac759a467_6ddf6387-acef-48ae-882a-dba388ad18c4.html,,,,,, 4-amino-N-(4-aminophenyl)benzenesulphonamide,16803-97-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e531a76b-8bc3-4e0b-88b0-f6d611028c6f/documents/64b7080b-a583-4375-b83f-a95ac759a467_6ddf6387-acef-48ae-882a-dba388ad18c4.html,,oral,LD50,"7,100 mg/kg bw",no adverse effect observed, 4-amino-N-(4-aminophenyl)benzenesulphonamide,16803-97-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e531a76b-8bc3-4e0b-88b0-f6d611028c6f/documents/64b7080b-a583-4375-b83f-a95ac759a467_6ddf6387-acef-48ae-882a-dba388ad18c4.html,,dermal,LD50,"4,506 mg/kg bw",no adverse effect observed, 4-amino-N-(4-aminophenyl)benzenesulphonamide,16803-97-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e531a76b-8bc3-4e0b-88b0-f6d611028c6f/documents/64b7080b-a583-4375-b83f-a95ac759a467_6ddf6387-acef-48ae-882a-dba388ad18c4.html,,inhalation,LC50,"5,200 mg/m3",no adverse effect observed, 4-anilino-3-nitro-N-phenylbenzenesulphonamide,5124-25-4,"In a combined repeated dose toxicity study with reproductive/developmental toxicity screening, the NOAEL (No Observed Adverse Effect Level) for systemic toxicity was established at 1000 mg/kg bw/day. The NOEL (No Observed Effect Level) for reproduction/developmental toxicity was considered to be 1000 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13102fa5-d508-41c1-9ac9-8017c9e64602/documents/IUC5-ea64d803-aef4-4af8-baae-aa7a34071809_274bfd12-7718-40af-9329-4e27e60a31b1.html,,,,,, 4-anilino-3-nitro-N-phenylbenzenesulphonamide,5124-25-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13102fa5-d508-41c1-9ac9-8017c9e64602/documents/IUC5-ea64d803-aef4-4af8-baae-aa7a34071809_274bfd12-7718-40af-9329-4e27e60a31b1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-anilino-3-nitro-N-phenylbenzenesulphonamide,5124-25-4,The oral LD50 of the test substance was considered to be >2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13102fa5-d508-41c1-9ac9-8017c9e64602/documents/IUC5-5d7d150f-e0e5-4532-b2d8-9229fcf060db_274bfd12-7718-40af-9329-4e27e60a31b1.html,,,,,, 4-anilino-3-nitro-N-phenylbenzenesulphonamide,5124-25-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13102fa5-d508-41c1-9ac9-8017c9e64602/documents/IUC5-5d7d150f-e0e5-4532-b2d8-9229fcf060db_274bfd12-7718-40af-9329-4e27e60a31b1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-anilinobenzenediazonium hydrogen sulphate,4477-28-5, LD50 > 50 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3b42abd-4f1c-439c-b42c-c26d8f548f90/documents/e377f310-0590-48d9-a1ce-9dcacc62fa2e_992c7786-4aa7-4dca-9f5c-59a2c57652fc.html,,,,,, "4-benzoylbenzene-1,2,3-triyl tris(6-diazo-5,6-dihydro-5-oxonaphthalene-1-sulphonate)",5610-94-6," A combined repeated dose toxicity study with reproduction/developmental toxicity screening test was performed according to OECD 422 and in accordance with GLP principles. Administration of Diazo PW 980 by once daily oral gavage was well tolerated in rats at levels of 1000 mg/kg bw/day without in-life observations of toxicity or histopathological findings in the F0 or F1 generation. There was no evidence of test item related changes to the mating and fertility, maternal behavior or pre-weaning viability. Mean litter weights and pre-weaning physical development were similar in all dose groups. Based on these results, the no-observed-effect level (NOEL) of parental, reproduction (up to and including implantation) and developmental (from implantation onwards) was considered to be 1000 mg/kg bw/day. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a9584ea-f21b-4295-99c6-8e91cb447314/documents/747432bd-b2b8-4d07-8003-5238b941bfaf_c3823794-842d-44cd-a24e-599eba3cef97.html,,,,,, "4-benzoylbenzene-1,2,3-triyl tris(6-diazo-5,6-dihydro-5-oxonaphthalene-1-sulphonate)",5610-94-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a9584ea-f21b-4295-99c6-8e91cb447314/documents/747432bd-b2b8-4d07-8003-5238b941bfaf_c3823794-842d-44cd-a24e-599eba3cef97.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4-benzoylbenzene-1,2,3-triyl tris(6-diazo-5,6-dihydro-5-oxonaphthalene-1-sulphonate)",5610-94-6,"Acute oral toxicity OECD 401 (RL1): LD50 > 5000 mg/kg bw, oral, male/female rats Acute dermal toxicity A study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (skin irritation, skin sensitisation) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): OECD Guideline study under GLP conditions ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a9584ea-f21b-4295-99c6-8e91cb447314/documents/5a9a6945-6e97-4215-9713-130766ef3ac8_c3823794-842d-44cd-a24e-599eba3cef97.html,,,,,, "4-benzoylbenzene-1,2,3-triyl tris(6-diazo-5,6-dihydro-5-oxonaphthalene-1-sulphonate)",5610-94-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a9584ea-f21b-4295-99c6-8e91cb447314/documents/5a9a6945-6e97-4215-9713-130766ef3ac8_c3823794-842d-44cd-a24e-599eba3cef97.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "4-bromo-1,2-dichlorobenzene",18282-59-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/782db655-2d76-4bbf-aa92-4d854af7d6c6/documents/320a651e-acfc-4b7e-a588-87bbc4161a6a_83a85d5c-a38e-4b86-84da-6da2e08cb770.html,,oral,LD50,1.098 mg/kg bw,, "4-bromo-1,2-dichlorobenzene",18282-59-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/782db655-2d76-4bbf-aa92-4d854af7d6c6/documents/320a651e-acfc-4b7e-a588-87bbc4161a6a_83a85d5c-a38e-4b86-84da-6da2e08cb770.html,,dermal,LD50,> 2 mg/kg bw,, "4-bromo-2,2-diphenylbutanenitrile",39186-58-8,"Repeated dose toxicity - Oral: In a combined repeated dose toxicity study with reproduction/developmental toxicity screening, the test substance was administered daily to rats at the dose level of 50, 150, and 500 mg/kg bw/day for 29 days for the males and 50-56 days for the females (OECD 422; Pels Rijcken, WR, 2018). A parental NOAEL of at least 500 mg/kg bw/day was established.   Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure.   Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ad396dd-4b08-4b99-b4a8-0b9b83be34eb/documents/9cb119d4-3a1e-4e2e-b782-68ce9e8481b5_434a5d19-aa67-4435-9501-79b478aabf8c.html,,,,,, "4-bromo-2,2-diphenylbutanenitrile",39186-58-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ad396dd-4b08-4b99-b4a8-0b9b83be34eb/documents/9cb119d4-3a1e-4e2e-b782-68ce9e8481b5_434a5d19-aa67-4435-9501-79b478aabf8c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "4-bromo-2,2-diphenylbutanenitrile",39186-58-8," Acute toxicity: Oral In an acute oral toxicity study in female Wistar rats, following the acute toxic class method in accordance with the OECD Guideline 423, the LD50 was established to be greater than 2000 mg/kg (Latour, 2016). Acute toxicity: Inhalation No reliable acute toxicity study via the inhalation route was available. However, this endpoint is waived as specific data are available for the oral and dermal exposure routes. Acute toxicity: Dermal No reliable acute toxicity study via the dermal route was available. However, this can be waived based on the fact that the substance does not meet the criteria for classification for acute toxicity or STOT SE by the oral route, and no systemic toxicity is observed in in vivo studies with dermal exposure. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ad396dd-4b08-4b99-b4a8-0b9b83be34eb/documents/5eb9f0c6-aab1-41e0-90d4-ef267acf5265_434a5d19-aa67-4435-9501-79b478aabf8c.html,,,,,, "4-bromo-2,2-diphenylbutanenitrile",39186-58-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ad396dd-4b08-4b99-b4a8-0b9b83be34eb/documents/5eb9f0c6-aab1-41e0-90d4-ef267acf5265_434a5d19-aa67-4435-9501-79b478aabf8c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-bromo-2-fluoro-1,1'-biphenyl",41604-19-7,"No experimental data were available for the Substance. Based on data available for structural analogues, acute toxicity is not expected. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5680a223-04e2-4b1c-9c30-87f67a412819/documents/4a12f0d4-4668-4717-9919-c2a5f70506be_1d75cd56-585e-4681-9159-b1fe975d1961.html,,,,,, "4-bromo-3,3,4,4-tetrafluorobut-1-ene",18599-22-9,"Description of relevant studies:  NOEL 1000 ppm - Two-week inhalation toxicity study in male rats - Malley, L.A. (2003) - Supporting study. No effects level not ID'd at concentrations tested - Repeated dose toxicity, Inhalation - Ferenz, R.L. (1980) - Supporting study. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80bea056-c08e-44fd-a1f6-3245aa2af608/documents/a60dbed9-7db8-45b0-a9cb-250060060e03_bbd9dcb2-9053-470f-adb9-ed0612d4929e.html,,,,,, "4-bromo-3,3,4,4-tetrafluorobut-1-ene",18599-22-9," Acute oral toxicity: Rat LD50 > 2000 mg/kg bw (OECD 423 Acute Toxic Class Method). Acute inhalation toxicity: Rat LC50 > 84650 mg/m3 (similar to Fixed Concentration Procedure, Reliability =2) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80bea056-c08e-44fd-a1f6-3245aa2af608/documents/952f6094-d9af-4a9a-846b-d50be50ddf0c_bbd9dcb2-9053-470f-adb9-ed0612d4929e.html,,,,,, "4-bromo-3,3,4,4-tetrafluorobut-1-ene",18599-22-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80bea056-c08e-44fd-a1f6-3245aa2af608/documents/952f6094-d9af-4a9a-846b-d50be50ddf0c_bbd9dcb2-9053-470f-adb9-ed0612d4929e.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4-bromo-3,3,4,4-tetrafluorobut-1-ene",18599-22-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80bea056-c08e-44fd-a1f6-3245aa2af608/documents/952f6094-d9af-4a9a-846b-d50be50ddf0c_bbd9dcb2-9053-470f-adb9-ed0612d4929e.html,,inhalation,discriminating conc.,"84,650 mg/m3",adverse effect observed, 4'-bromo-3-chloropropiophenone,31736-73-9,"OECD 423 (RL1, rat): LD50 > 2000 mg/kg bw  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): OECD Guideline study under GLP conditions. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8cdfd81a-cd51-450b-8c6b-219e7fed1769/documents/b660a73c-fec4-4e9a-8b3b-2536727313e2_57f0625b-acbb-43a7-a59b-f0797aeb0b4e.html,,,,,, 4'-bromo-3-chloropropiophenone,31736-73-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8cdfd81a-cd51-450b-8c6b-219e7fed1769/documents/b660a73c-fec4-4e9a-8b3b-2536727313e2_57f0625b-acbb-43a7-a59b-f0797aeb0b4e.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4-Bromo-9,9-dimethyl-9H-fluorene",942615-32-9,The LD50 value for the test item is higher than 2000 mg/kg bw after single oral administration to female rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c62e203-b728-45ae-a3b6-16331bc48c61/documents/1fdbbfb9-b8c4-42aa-b0c5-2292894c5061_9992aca5-212f-4088-a621-dbeacc3e8c8d.html,,,,,, "4-Bromo-9,9-dimethyl-9H-fluorene",942615-32-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c62e203-b728-45ae-a3b6-16331bc48c61/documents/1fdbbfb9-b8c4-42aa-b0c5-2292894c5061_9992aca5-212f-4088-a621-dbeacc3e8c8d.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4-bromo-9,9'-Spirobi[9H-fluorene]",1161009-88-6," Acute toxicity was studied in rodents after oral and dermal administration. The oral route was chosen as most relevant route of exposure. The dermal study was initiated based on data obtained in the OECD 429 dose range finiding assay. Here, the test material caused severe systemic toxicity in mice after dermal administration using DMF as vehicle at concentrations down to 10%, significant body weight loss down to 2.5% and local irritation at lower concentrations down to 0.5 %. Therefore, an additional dermal toxicity study in rats was initiated to ensure occupational safety. The following results have been obtained: OECD 423: LD50 > 2000 mg/kg bw OECD 402: LD50 > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31d2352e-7add-4f76-abb8-cd367ae2da5a/documents/aea939cc-8acb-438f-b9e6-07e57de4dd45_2e51cd5f-1cf6-4182-b82f-d9710d418f32.html,,,,,, "4-bromo-9,9'-Spirobi[9H-fluorene]",1161009-88-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31d2352e-7add-4f76-abb8-cd367ae2da5a/documents/aea939cc-8acb-438f-b9e6-07e57de4dd45_2e51cd5f-1cf6-4182-b82f-d9710d418f32.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-bromo-9,9'-Spirobi[9H-fluorene]",1161009-88-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31d2352e-7add-4f76-abb8-cd367ae2da5a/documents/aea939cc-8acb-438f-b9e6-07e57de4dd45_2e51cd5f-1cf6-4182-b82f-d9710d418f32.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-bromoanisole,104-92-7,One study is available for the acute toxicity endpoint:Acute Oral toxicity: oral.001 - LD50 (rat): =1907 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55aaff21-7b70-4d25-8e31-a44f8280a439/documents/IUC5-ae7d9688-c887-4d8f-9d71-1b47b5b8e576_b9b712a3-4104-4c6b-ad7e-f627031776a1.html,,,,,, 4-bromoanisole,104-92-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55aaff21-7b70-4d25-8e31-a44f8280a439/documents/IUC5-ae7d9688-c887-4d8f-9d71-1b47b5b8e576_b9b712a3-4104-4c6b-ad7e-f627031776a1.html,,oral,LD50,"1,907 mg/kg bw",, 4-bromobenzyl alcohol,873-75-6," After treatment with the test item locomotor disturbance and dyspnea on day 1 of the experimental phase was seen and one rat treated with 2000 mg/kg died 4 hours after treatment. However, the LD50 value is higher than 2000 mg/kg after single oral administration in female rats (reference 7.2.1 -1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f8d4be7-fb49-4deb-b1f0-f273b33d57d1/documents/e05ced10-607d-4d5c-ae88-b4ea36c382d6_275fd524-0ef0-4955-aadf-dcf084458ae9.html,,,,,, 4-bromobenzyl alcohol,873-75-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f8d4be7-fb49-4deb-b1f0-f273b33d57d1/documents/e05ced10-607d-4d5c-ae88-b4ea36c382d6_275fd524-0ef0-4955-aadf-dcf084458ae9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-Bromo-Isoindoline HCl,923590-95-8, Oral Toxicity (rat): 300 mg/Kg < LD50 < 2000 mg/Kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e4c8a06-c74b-4795-afcd-02ad947f609c/documents/1969bba1-4e53-442b-a263-41753b10c5da_2071e82d-eea4-45f3-b301-c74b555e098c.html,,,,,, 4-Bromo-Isoindoline HCl,923590-95-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e4c8a06-c74b-4795-afcd-02ad947f609c/documents/1969bba1-4e53-442b-a263-41753b10c5da_2071e82d-eea4-45f3-b301-c74b555e098c.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "(4-butoxy-2,3-difluorophenyl)boronic acid",156487-12-6, GLP compiant OECD 423 ATC Study: LD50 between 300 and 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/babf08e3-2b37-42e7-b9ee-ba563a105c8f/documents/61001eac-32d7-4f91-847f-750fb771054d_1c26486e-733f-485d-bef9-61ed2ea58587.html,,,,,, "(4-butoxy-2,3-difluorophenyl)boronic acid",156487-12-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/babf08e3-2b37-42e7-b9ee-ba563a105c8f/documents/61001eac-32d7-4f91-847f-750fb771054d_1c26486e-733f-485d-bef9-61ed2ea58587.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, "4''-Butoxy-4-ethyl-2',2'',3''-trifluoro-[1,1':4',1'']-terphenyl",612543-60-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9aecb22b-be7e-4e8c-a7dd-02bb92d1aa6a/documents/f864e160-0023-4304-838e-c2db26034318_c7ee70da-fa88-4391-b396-28dec6367800.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4'-Butyl-4-ethoxy-2,3-difluoro-1,1'-biphenyl",1229661-51-1," OECD 423: LD50 (rat, oral) > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1338767-40c5-42b7-bb4d-03f326e6a949/documents/7bbc024e-98f1-40b9-95b9-82ccf1633090_59af18a7-fe61-49fb-983c-dd1ba35a5e06.html,,,,,, "4'-Butyl-4-ethoxy-2,3-difluoro-1,1'-biphenyl",1229661-51-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1338767-40c5-42b7-bb4d-03f326e6a949/documents/7bbc024e-98f1-40b9-95b9-82ccf1633090_59af18a7-fe61-49fb-983c-dd1ba35a5e06.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4-Butyl-4''-ethyl-2',3'-difluor-1,1':4',1''-terphenyl",486406-09-1,The acute oral LD50 of the read-across source substance was determined to be > 2000 mg/kg bw in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc132d0c-738f-4c69-82a2-4f590ee18e5a/documents/0eb5c555-d2d9-4dc2-a98e-b58b8d7b491c_279f9b3a-7fb1-41cd-86c7-2ca60901378c.html,,,,,, "4-Butyl-4''-ethyl-2',3'-difluor-1,1':4',1''-terphenyl",486406-09-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc132d0c-738f-4c69-82a2-4f590ee18e5a/documents/0eb5c555-d2d9-4dc2-a98e-b58b8d7b491c_279f9b3a-7fb1-41cd-86c7-2ca60901378c.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4-Butyl-4''-ethyl-2'-fluor-1,1':4',1''-terphenyl",825633-75-8,For this endpoint information from a structural similar compound is available. This study for this similar compound was performed according to GLP and the methods applied are fully compliant with OECD TG 423. See chapter 13 report for a more detailed justification. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3e34ce1-b6c6-48f9-b7df-919a3c3dca82/documents/103c2f56-8e36-46d5-952b-fee1ea470bee_c501665b-3e1b-4a13-9f18-ad5b8b89344e.html,,,,,, "4-Butyl-4''-ethyl-2'-fluor-1,1':4',1''-terphenyl",825633-75-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3e34ce1-b6c6-48f9-b7df-919a3c3dca82/documents/103c2f56-8e36-46d5-952b-fee1ea470bee_c501665b-3e1b-4a13-9f18-ad5b8b89344e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-chloro-1-methylpiperidinium chloride,5382-23-0," Acute oral toxicity LD50 was estimated to be 2230.54mg/kg bw, when male Carworth-Wistar rats were exposed with 4-chloro-1-methylpiperidin-1-ium chloride (5382-23-0) orally. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee056694-9d49-4441-ad5c-1da893a06e5e/documents/f261185d-fd73-41e4-aaed-463511895f1f_14bb7a85-66b5-4ac6-af32-b1c4b9977ec1.html,,,,,, 4-chloro-1-methylpiperidinium chloride,5382-23-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee056694-9d49-4441-ad5c-1da893a06e5e/documents/f261185d-fd73-41e4-aaed-463511895f1f_14bb7a85-66b5-4ac6-af32-b1c4b9977ec1.html,,oral,LD50,"2,230.54 mg/kg bw",no adverse effect observed, "4'-chloro-2',5'-dimethoxyacetoacetanilide",4433-79-8,"Key study similar to OECD 401 (KEY_401_1977_HUNTINGTON_LONZA Report No 0315): 850 mg/kg bw (rat)Supporting study similar to OECD 401 (NONKEY_401_1974_HOECHST_1974.0200) LD50: 1154 mg/kg bw (rat)Supporting study following no guideline (NONKEY_401_1973_Consultox_LONZA Report No 0313): >2500 mg/kg bw (rat, range finding study) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f80bb3b1-5aec-448a-8b50-fe7d9bae606e/documents/IUC5-664e1c09-4799-44d1-8b0a-ca2a9d460d51_1f9a0a6f-1527-45bd-818a-a25c3103d068.html,,,,,, "4'-chloro-2',5'-dimethoxyacetoacetanilide",4433-79-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f80bb3b1-5aec-448a-8b50-fe7d9bae606e/documents/IUC5-664e1c09-4799-44d1-8b0a-ca2a9d460d51_1f9a0a6f-1527-45bd-818a-a25c3103d068.html,,oral,LD50,850 mg/kg bw,, "4-chloro-1H-pyrrolo[2,3-d]pyrimidine",3680-69-1,"Refer to the OECD Guideline 407, a repeated Dose 28-Day Oral Toxicity Study in Sprague Dawley rats with 4-CPP was performed. The no-adverse-observed-effect-level (NOAEL) for 4-CPP in the repeated dose 28-day oral toxicity study in SD rats under the condition of the study was considered to be 30 mg/kg body weight/day for both sexes.The lowest-observed-adverse-effect level (LOAEL) was considered to be 200 mg/kg body weight/day for both sexes, based on the diffuse follicular cell hyperplasia/hypertrophy of thyroid glands. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93225399-e9f6-4023-8fc8-75bfa7315191/documents/0dc5b48c-42fb-4fce-9848-03b11fe96491_30364968-ec05-4327-8e28-076998124969.html,,,,,, "4-chloro-1H-pyrrolo[2,3-d]pyrimidine",3680-69-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93225399-e9f6-4023-8fc8-75bfa7315191/documents/0dc5b48c-42fb-4fce-9848-03b11fe96491_30364968-ec05-4327-8e28-076998124969.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "4-chloro-1H-pyrrolo[2,3-d]pyrimidine",3680-69-1,The estimated oral LD50 and 95% confidence limits of the test item is 1161 (550 to 2000) mg/kg of body weight in female rats. The acute dermal LD50 in rats for 4-CPP was estimated to be more than 2000 mg/kg b.w. in female SD rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93225399-e9f6-4023-8fc8-75bfa7315191/documents/aad3a9f4-5bb8-4f8e-8297-2e8d92a96ba8_30364968-ec05-4327-8e28-076998124969.html,,,,,, "4-chloro-1H-pyrrolo[2,3-d]pyrimidine",3680-69-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93225399-e9f6-4023-8fc8-75bfa7315191/documents/aad3a9f4-5bb8-4f8e-8297-2e8d92a96ba8_30364968-ec05-4327-8e28-076998124969.html,,oral,LD50,"1,161 mg/kg bw",adverse effect observed, "4-chloro-1H-pyrrolo[2,3-d]pyrimidine",3680-69-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93225399-e9f6-4023-8fc8-75bfa7315191/documents/aad3a9f4-5bb8-4f8e-8297-2e8d92a96ba8_30364968-ec05-4327-8e28-076998124969.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 4'-chloroacetophenone,99-91-2," For acute oral toxicity there is one animal study available conducted before implementation of the OECD guidelines. The study indicated a mouse LD50 oral 1207 (1150 -1267) mg/kg bw. This result needs to be considered for classification in category 4 (acute tox.4, H302). There are no reliable reports whatsoever on acute dermal toxicity as well as acute inhalation toxicity in the public domain. A mouse LD50 intraperitoneal 735 (691 -781) mg/kg bw was reported for 4-Chloroacetophenone from Bekemeier and Köster 1976. A mouse LD50 intraperitoneal 100 mg/kg bw was reported from National Technical Information Service. However, the respective test substance is not specified as to its chemical form. Therefore this data entry is disregarded. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27909113-ff52-4ea5-bddf-90fe4de6b854/documents/c06e6be4-6b6f-4bb0-af44-5f2384cd1be0_686fefa0-e2fb-4a83-856e-39b3507035d9.html,,,,,, 4'-chloroacetophenone,99-91-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27909113-ff52-4ea5-bddf-90fe4de6b854/documents/c06e6be4-6b6f-4bb0-af44-5f2384cd1be0_686fefa0-e2fb-4a83-856e-39b3507035d9.html,,oral,LD50,"1,207 mg/kg bw",adverse effect observed, 4-chlorobenzenesulphonic acid,98-66-8," A prediction model for acute oral toxicity on mouse and rat provides LD50 predictions for mice and rat by oral administration route. LD50(rat oral) was provided equal to 5900 mg/kg, and the prediction was assessed as moderate reliable. LD50(mouse oral) was provided equal to 5200 mg/kg, and the prediction was assessed as borderline reliable. LD50(rat oral) > 500 mg/kg (Source: Oxford University Chemical Safety data - ChemSpider data base) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea2b9a20-449a-4520-afa5-bd0117482a5f/documents/ddedae82-8551-4a0c-837f-74fd5bfdfd68_6428ed0a-feb4-411d-83c1-a66356315ae9.html,,,,,, 4-chlorobenzenesulphonic acid,98-66-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea2b9a20-449a-4520-afa5-bd0117482a5f/documents/ddedae82-8551-4a0c-837f-74fd5bfdfd68_6428ed0a-feb4-411d-83c1-a66356315ae9.html,,oral,LD50,"5,900 mg/kg bw",no adverse effect observed, 4-chlorobenzonitrile,623-03-0," A study on the acute oral toxicty of 4-Chlorobenzonitrile was performed according to OECD 423. In conclusion, the LD50 of 4-Chlorobenzonitrile is between 300 and 2000 mg/kg bodyweight by oral route in the rat. In accordance with the OECD 423 (Annex 2d), the LD50 cut-off of the test item may be considered to be 500 mg/kg body weight by oral route in the rat. The LD50 value was also extracted from the manufacturers’ safety data sheet. Additional short-term data is presented in Section 7.9.3. An LD50 > 300mg/kg was confirmed (Heilmann, 1978). A single i.p. injection of 1.5 mmol/kg was reported not leading to hepatotoxic effects (Hanzlik, 1978). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b78cbf08-5219-4e2e-8f8a-e5f89c316572/documents/IUC5-67836fb9-31e5-4130-a4db-91fe0f902731_cd9c4566-7219-469f-95ce-ac2ce0c04fc0.html,,,,,, 4-chlorobenzonitrile,623-03-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b78cbf08-5219-4e2e-8f8a-e5f89c316572/documents/IUC5-67836fb9-31e5-4130-a4db-91fe0f902731_cd9c4566-7219-469f-95ce-ac2ce0c04fc0.html,,oral,LD50,500 mg/kg bw,adverse effect observed, 4-chlorobenzophenone,134-85-0,"Repeated Dose Toxicity: Oral Based on the available results and applying the weight of evidence approach, the test chemical can be considered to be non-toxic to living organisms when dosed repeatedly via oral route. The No Observed Adverse Effect Level can be considered to be >1000 mg/kgbw/day. Comparing the above annotations with the criteria of CLP Regulation, the test chemical can be classified under the category “Not Classified”.   Repeated Dose toxicity: Inhalation A short-term toxicity study need not be conducted as because exposure of humans via inhalation route in production and/or use is not likely based on the provided thorough and rigorous exposure.   Repeated Dose Toxicity: Dermal A short-term toxicity study need not be conducted as because exposure of humans via dermal route in production and/or use is not likely based on the provided thorough and rigorous exposure assessment.   ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e56c59d-65fd-47ac-aff8-1bc7b02c59b2/documents/3df11bf2-3702-47bd-ad26-8a5b646ccb5e_4fc24903-3271-4af8-9767-f6ac2a1012cc.html,,,,,, 4-chlorobenzophenone,134-85-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e56c59d-65fd-47ac-aff8-1bc7b02c59b2/documents/3df11bf2-3702-47bd-ad26-8a5b646ccb5e_4fc24903-3271-4af8-9767-f6ac2a1012cc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-chlorobenzophenone,134-85-0,"Acute Oral Toxicity : Study 1: Based on all the observations and results, the acute oral LD50 (cut-off value) of the test chemical was 5000 mg/kg body weight. Thus, by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that the test chemical does not exhibit acute oral toxicity i.e it is acutely non toxic to animals. Study 2: Slight lethargy was observed during the course of the study. The LD50 exceeded 5 g/kg based on one (1/10) death at that dose. Thus, based on all the observations and results, it was concluded that the test chemical is not acutely toxic to the rats when administered at 5000 mg/kg bw. Acute Inhalation Toxicity : Waiver Acute Dermal Toxicity : Study 1: Based on all the available observations and results, it was concluded that, the LD50 was considered to be >2000mg/kg bw, when rats were treated with test chemical by dermal application. Study 2:  Under the conditions of the study, the acute dermal toxicity dose (LD50) was considered to be >2000 mg/kg bw, when rats were treated with the test chemical by dermal application. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e56c59d-65fd-47ac-aff8-1bc7b02c59b2/documents/ffdda9c6-e819-460e-b85c-598dcfc07af8_4fc24903-3271-4af8-9767-f6ac2a1012cc.html,,,,,, 4-chlorobenzophenone,134-85-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e56c59d-65fd-47ac-aff8-1bc7b02c59b2/documents/ffdda9c6-e819-460e-b85c-598dcfc07af8_4fc24903-3271-4af8-9767-f6ac2a1012cc.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, 4-chlorobenzophenone,134-85-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e56c59d-65fd-47ac-aff8-1bc7b02c59b2/documents/ffdda9c6-e819-460e-b85c-598dcfc07af8_4fc24903-3271-4af8-9767-f6ac2a1012cc.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 4-chloroformylphthalic anhydride,1204-28-0," Repeated dose toxicity - oral route (diet): - NOAEL (rat)= 438.4 mg/kg bw/day, No systemic toxicity (Read-Across, no guideline followed, GLP not specified, K, rel.2) and, - NOAEL (rat, male)= 404 mg/kg bw/day, NOAEL (rat, female)= 418 mg/kg bw/day, No systemic toxicity (Read-Across, no guideline followed, GLP not specified, K, rel.2) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44d56828-2a6f-4b56-95f3-c1e136deb8e2/documents/a464af6c-6c6e-4a05-a65e-f5eb9759f78d_d6e0fca1-e312-4f09-9510-bb10d8f7a5e7.html,,,,,, 4-chloroformylphthalic anhydride,1204-28-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44d56828-2a6f-4b56-95f3-c1e136deb8e2/documents/a464af6c-6c6e-4a05-a65e-f5eb9759f78d_d6e0fca1-e312-4f09-9510-bb10d8f7a5e7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,404 mg/kg bw/day,,rat 4-chloroformylphthalic anhydride,1204-28-0," Acute toxicity - oral route: LD50 > 2000 mg/kg bw and < 5000 mg/kg bw (OECD 401, not GLP compliant, K, rel.2 and Read-Across, OECD 401, not GLP compliant, S, rel.1) Acute toxicity - inhalation route: Waiver and LD50 > 1.0 mg/L and < 5 mg/L (Read-Across, OECD 403, GLP compliant, S, rel.1) Acute toxicity - dermal route: Waiver (corrosivity) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44d56828-2a6f-4b56-95f3-c1e136deb8e2/documents/IUC5-534b9352-ce31-4ba6-8d90-e5483fa4a5db_d6e0fca1-e312-4f09-9510-bb10d8f7a5e7.html,,,,,, 4-chloroformylphthalic anhydride,1204-28-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44d56828-2a6f-4b56-95f3-c1e136deb8e2/documents/IUC5-534b9352-ce31-4ba6-8d90-e5483fa4a5db_d6e0fca1-e312-4f09-9510-bb10d8f7a5e7.html,,oral,LD50,"3,192 mg/kg bw",adverse effect observed, 4-chloroformylphthalic anhydride,1204-28-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44d56828-2a6f-4b56-95f3-c1e136deb8e2/documents/IUC5-534b9352-ce31-4ba6-8d90-e5483fa4a5db_d6e0fca1-e312-4f09-9510-bb10d8f7a5e7.html,,inhalation,LC50,"2,550 mg/m3",adverse effect observed, 4-chloro-o-cresol,1570-64-5,4-Chloro-o-cresol is classified as toxic by inhalation. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27394182-ae82-473a-ae24-0de41fce96d5/documents/IUC5-7f2ca044-678c-47b0-bba4-1adf1c19f9e2_74af43f3-8d03-4880-af14-085204d6c623.html,,,,,, 4-chloro-o-xylene,615-60-1,"ORALNOAEL <50 mg/kg/day, Sprague-Dawley rat, OECD 407 (Marr, 2005) ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e5b60fc-87a3-421a-8930-bbe9f9469e86/documents/IUC5-84c834e5-4ff5-40cd-910c-7792a77b43d8_e5008f76-3018-4e2c-a7a1-474728315ee1.html,,,,,, 4-chloro-o-xylene,615-60-1,"ORALLD50 >2000 mg/kg bw, female rat, OECD 425 (Tay, 2004)DERMALLD50 >2000 mg/kg bw, New Zealand Rabbit, OECD 402 (Chin, 2004) ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e5b60fc-87a3-421a-8930-bbe9f9469e86/documents/IUC5-d2095832-925a-4cff-a45c-c1aab8b7a6de_e5008f76-3018-4e2c-a7a1-474728315ee1.html,,,,,, 4-chloro-o-xylene,615-60-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e5b60fc-87a3-421a-8930-bbe9f9469e86/documents/IUC5-d2095832-925a-4cff-a45c-c1aab8b7a6de_e5008f76-3018-4e2c-a7a1-474728315ee1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-chloro-o-xylene,615-60-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e5b60fc-87a3-421a-8930-bbe9f9469e86/documents/IUC5-d2095832-925a-4cff-a45c-c1aab8b7a6de_e5008f76-3018-4e2c-a7a1-474728315ee1.html,,dermal,LD50,"2,000 mg/kg bw",, 4-chlorotoluene,106-43-4,"In a subacute study 5 male and female Wistar rats each received for 29 days a dose of 0, 50, 200, or 800 mg/kg bw p-chlorotoluene per gavage. Mortality, clinical signs, body weight, clinical chemistry, hematology and urinalysis were performed including gross pathology and histopathology after the termination of the study.No studies are available for repeated dose dermal and inhalative toxicity ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9dfa9cf-8c99-4995-9163-d507c3bdc522/documents/IUC5-97604d79-eefa-48a5-8e95-287d32b772d0_5efee589-06b6-41b6-895a-8c87c8e1b5c2.html,,,,,, 4-chlorotoluene,106-43-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9dfa9cf-8c99-4995-9163-d507c3bdc522/documents/IUC5-97604d79-eefa-48a5-8e95-287d32b772d0_5efee589-06b6-41b6-895a-8c87c8e1b5c2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,, 4-chlorotoluene,106-43-4,"In 2 valid studies an oral LD50 ca. 2273 mg/kg bw (rat, male) and LD50 = 2389 mg/kg bw (rat, female) were found. For acute dermal toxicity a LD50 > 5000 mg/kg bw was determined in 2 valid dermal toxicity test.An inhalation-hazard test is available for acute inhalation toxicity. Rats exposed for 4182.6ppm (ca. 22000 mg/m³) for 4 hours 0/6 animals died. Rats exposed to 3950.9 ppm (ca. 21578 mg/m³) for 5 hours 3/6 animals died. Rats exposed to 3950.9 ppm (ca. 20781 mg/m³) or 4304.2 ppm (ca. or 4304.2 ppm (ca.22640 mg/m³) for 6 or 8 hours 6/6 animals died. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9dfa9cf-8c99-4995-9163-d507c3bdc522/documents/IUC5-3e6a38a6-77cc-40b1-a5f1-5b25ae763be1_5efee589-06b6-41b6-895a-8c87c8e1b5c2.html,,,,,, 4-chlorotoluene,106-43-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9dfa9cf-8c99-4995-9163-d507c3bdc522/documents/IUC5-3e6a38a6-77cc-40b1-a5f1-5b25ae763be1_5efee589-06b6-41b6-895a-8c87c8e1b5c2.html,,oral,LD50,"2,273 mg/kg bw",, 4-chlorotoluene,106-43-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9dfa9cf-8c99-4995-9163-d507c3bdc522/documents/IUC5-3e6a38a6-77cc-40b1-a5f1-5b25ae763be1_5efee589-06b6-41b6-895a-8c87c8e1b5c2.html,,dermal,LD50,"5,000 mg/kg bw",, "4-chloro-α,α,α-trifluoro-m-toluidine",320-51-4,"Oral gavage (Rat, GLP, OECD 407, July 2008) Based on the hemoglobin reduction in females at 100 mg/kg by >20% (LOAEL), the no observed adverse effect level (NOAEL) is 30 mg/kg in the context of this study.     ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11eb07f4-90a3-4cbc-be8c-bb29cdaaa70e/documents/f3052ca3-c391-47cb-a1dc-00e0b711e549_4f426293-ea81-45c7-bd05-7b6763be0e6f.html,,,,,, "4-chloro-α,α,α-trifluoro-m-toluidine",320-51-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11eb07f4-90a3-4cbc-be8c-bb29cdaaa70e/documents/f3052ca3-c391-47cb-a1dc-00e0b711e549_4f426293-ea81-45c7-bd05-7b6763be0e6f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "4-chloro-α,α,α-trifluoro-m-toluidine",320-51-4,"-study conducted according to OECD TG 423; result: LD50:> 300 < 2000 mg/kg bw -study conducted according to OECD TG 436; result: LD50: > 1082 < 2082 mg/m³ -study conducted according to OECD TG 402; result: LD50: > 1000 < 2000 mg/kg bw Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): High quality; guideline study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): High quality; guideline study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): High quality; guideline study ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11eb07f4-90a3-4cbc-be8c-bb29cdaaa70e/documents/a59ea30f-2a18-4a37-88fa-086b5f9c47d4_4f426293-ea81-45c7-bd05-7b6763be0e6f.html,,,,,, "4-chloro-α,α,α-trifluoro-m-toluidine",320-51-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11eb07f4-90a3-4cbc-be8c-bb29cdaaa70e/documents/a59ea30f-2a18-4a37-88fa-086b5f9c47d4_4f426293-ea81-45c7-bd05-7b6763be0e6f.html,,oral,LD50,>=300 mg/kg bw,adverse effect observed, "4-chloro-α,α,α-trifluoro-m-toluidine",320-51-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11eb07f4-90a3-4cbc-be8c-bb29cdaaa70e/documents/a59ea30f-2a18-4a37-88fa-086b5f9c47d4_4f426293-ea81-45c7-bd05-7b6763be0e6f.html,,dermal,LD50,">=1,000 mg/kg bw",adverse effect observed, "4-chloro-α,α,α-trifluoro-m-toluidine",320-51-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11eb07f4-90a3-4cbc-be8c-bb29cdaaa70e/documents/a59ea30f-2a18-4a37-88fa-086b5f9c47d4_4f426293-ea81-45c7-bd05-7b6763be0e6f.html,,inhalation,LC50,">=1,082 mg/m3",adverse effect observed, "4-chloro-α,α,α-trifluorotoluene",98-56-6,The lowest available oral NOAEL is a 90-d value of 40 mg/kg bw/day and the lowest available inhalation 90-d NOAEC is 51 mg/m³. No information on dermal effects of subchronic exposure is available. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b32fc6cd-fce9-4e81-98ca-efe7d45c3635/documents/c1480232-2151-4e52-8dc6-9c0238658ff7_67d697e4-7c1f-43f9-ac4c-ef7fe53b5619.html,,,,,, "4-chloro-α,α,α-trifluorotoluene",98-56-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b32fc6cd-fce9-4e81-98ca-efe7d45c3635/documents/c1480232-2151-4e52-8dc6-9c0238658ff7_67d697e4-7c1f-43f9-ac4c-ef7fe53b5619.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat "4-chloro-α,α,α-trifluorotoluene",98-56-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b32fc6cd-fce9-4e81-98ca-efe7d45c3635/documents/c1480232-2151-4e52-8dc6-9c0238658ff7_67d697e4-7c1f-43f9-ac4c-ef7fe53b5619.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,51 mg/m3,,rat "4-chloro-α,α,α-trifluorotoluene",98-56-6,"Acute oral LD50 = 5546 mg/kg bw Acute inhalatory LC50 > 32 mg/L Acute dermal LD50 > 3300 mg/kg bw Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The key study is no GLP compliant, but is of high quality (Klimisch score = 2) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The key study is GLP compliant and it is of high quality (Klimisch score = 1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The two studies are non GLP and non-guideline compliant; however they together form a reliable weight of evidence. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b32fc6cd-fce9-4e81-98ca-efe7d45c3635/documents/1a8701ce-e416-4833-a339-de285a7ecad1_67d697e4-7c1f-43f9-ac4c-ef7fe53b5619.html,,,,,, "4-chloro-α,α,α-trifluorotoluene",98-56-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b32fc6cd-fce9-4e81-98ca-efe7d45c3635/documents/1a8701ce-e416-4833-a339-de285a7ecad1_67d697e4-7c1f-43f9-ac4c-ef7fe53b5619.html,,oral,LD50,"5,546 mg/kg bw",no adverse effect observed, "4-chloro-α,α,α-trifluorotoluene",98-56-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b32fc6cd-fce9-4e81-98ca-efe7d45c3635/documents/1a8701ce-e416-4833-a339-de285a7ecad1_67d697e4-7c1f-43f9-ac4c-ef7fe53b5619.html,,dermal,discriminating dose,"3,300 mg/kg bw",no adverse effect observed, "4-chloro-α,α,α-trifluorotoluene",98-56-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b32fc6cd-fce9-4e81-98ca-efe7d45c3635/documents/1a8701ce-e416-4833-a339-de285a7ecad1_67d697e4-7c1f-43f9-ac4c-ef7fe53b5619.html,,inhalation,discriminating conc.,"32,032 mg/m3",no adverse effect observed, (4Z)-cyclopentadec-4-en-1-one,14595-54-1,Acute toxicity: oral: LD50 > 2000 mg/kg bw (OECD 401 in rats; rel.1) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5fdf4cb-be7e-41dc-9009-e4d5022559b0/documents/IUC5-a521415b-20a3-4189-ac6c-ff9161667a98_7e43dd8d-b479-497d-a399-871a77c20951.html,,,,,, (4Z)-cyclopentadec-4-en-1-one,14595-54-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5fdf4cb-be7e-41dc-9009-e4d5022559b0/documents/IUC5-a521415b-20a3-4189-ac6c-ff9161667a98_7e43dd8d-b479-497d-a399-871a77c20951.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "9-Hydroxy-5,9-dimethyl-4-decenal",926-50-1," NOAEL = 800 mg/kg/day for males or females (OECD 407, GLP, K, rel. 1) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3b3d6fd-da6d-413f-91f3-d8dea8450bb6/documents/64f22d4f-669d-4f46-9488-d68de3560a58_bbff369d-5c77-47c9-86cb-36eff3b10a50.html,,,,,, "9-Hydroxy-5,9-dimethyl-4-decenal",926-50-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3b3d6fd-da6d-413f-91f3-d8dea8450bb6/documents/64f22d4f-669d-4f46-9488-d68de3560a58_bbff369d-5c77-47c9-86cb-36eff3b10a50.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,800 mg/kg bw/day,,rat "9-Hydroxy-5,9-dimethyl-4-decenal",926-50-1," Oral Oral LD50 > 2000 mg/kg bw (OECD 420, K, Rel.1, Fixed dose Method adopted in December 2001) Inhalation No data Dermal Dermal LD50 > 2000 mg/kg bw (OECD 402, K, Rel.1, Acute Dermal Toxicity adopted in February 1987) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3b3d6fd-da6d-413f-91f3-d8dea8450bb6/documents/5f713005-438d-48e3-a4d0-26dd2368ee8b_bbff369d-5c77-47c9-86cb-36eff3b10a50.html,,,,,, "9-Hydroxy-5,9-dimethyl-4-decenal",926-50-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3b3d6fd-da6d-413f-91f3-d8dea8450bb6/documents/5f713005-438d-48e3-a4d0-26dd2368ee8b_bbff369d-5c77-47c9-86cb-36eff3b10a50.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "9-Hydroxy-5,9-dimethyl-4-decenal",926-50-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3b3d6fd-da6d-413f-91f3-d8dea8450bb6/documents/5f713005-438d-48e3-a4d0-26dd2368ee8b_bbff369d-5c77-47c9-86cb-36eff3b10a50.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-dimethylaminobenzaldehyde,100-10-7, GLP OECD TG 423: LD50 > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a56a7d7-ebb8-4fe7-bda1-1cc6fca0bbcf/documents/a5f021d5-35a8-420e-afd6-9d45d258a5fe_04842397-1aaa-4231-917e-ce0150124d53.html,,,,,, 4-dimethylaminobenzaldehyde,100-10-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a56a7d7-ebb8-4fe7-bda1-1cc6fca0bbcf/documents/a5f021d5-35a8-420e-afd6-9d45d258a5fe_04842397-1aaa-4231-917e-ce0150124d53.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-ethenylphenyl acetate,2628-16-2, Oral LD50 = 1732 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4adf178e-8c1e-44d2-98b0-aa1f638356b2/documents/6a620c32-9c0a-4cc5-ac3d-cba31e0ccdb7_77242cdd-615f-4f56-a1ee-8ceaa270f1cb.html,,,,,, "4-Ethoxy-2,3-difluoro-4'-methyl-1,1'-biphenyl",475644-24-7,"The test item has no acute toxic potential and that the LD50 value is higher than 2000 mg/kg bw after single oral administration in female rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The guideline and GLP conform study is of sufficient quality to address the endpoint. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a945781c-88ff-454c-b6ef-8f1769b9487c/documents/08993a18-e6e5-4d23-82bf-9dfdd2cfa07f_4de79c5f-ffd3-4a1d-a2f1-213d6ec7bcb7.html,,,,,, "4-Ethoxy-2,3-difluoro-4'-methyl-1,1'-biphenyl",475644-24-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a945781c-88ff-454c-b6ef-8f1769b9487c/documents/08993a18-e6e5-4d23-82bf-9dfdd2cfa07f_4de79c5f-ffd3-4a1d-a2f1-213d6ec7bcb7.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4-Ethoxy-2,3-difluor-4'-propyl-1,1'-biphenyl",157248-24-3,"The no adverse effect level (NOAEL) of the test item regarding systemic toxicity is considered to be 300 mg/kg bw/d. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The guideline and GLP conform study is of sufficient quality to address the endpoint. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/458f86f3-3de0-490a-9724-6437a346912b/documents/7b182271-b613-4700-b50d-59d557e00e7d_5fd3b5dc-0a89-4896-ae28-c69bb69027a6.html,,,,,, "4-Ethoxy-2,3-difluor-4'-propyl-1,1'-biphenyl",157248-24-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/458f86f3-3de0-490a-9724-6437a346912b/documents/7b182271-b613-4700-b50d-59d557e00e7d_5fd3b5dc-0a89-4896-ae28-c69bb69027a6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "4-Ethoxy-2,3-difluor-4'-propyl-1,1'-biphenyl",157248-24-3,"The test material showed no acute toxic potential and the LD50 value was determinded to be higher than 2000 mg/kg bw after single oral administration in rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The guideline and GLP conform study is of sufficient quality to address the endpoint. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/458f86f3-3de0-490a-9724-6437a346912b/documents/f26ed937-7dfa-45e3-b01a-bdbb63972461_5fd3b5dc-0a89-4896-ae28-c69bb69027a6.html,,,,,, "4-Ethoxy-2,3-difluor-4'-propyl-1,1'-biphenyl",157248-24-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/458f86f3-3de0-490a-9724-6437a346912b/documents/f26ed937-7dfa-45e3-b01a-bdbb63972461_5fd3b5dc-0a89-4896-ae28-c69bb69027a6.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4-Ethoxy-2,3-difluorphenylboronic acid",212386-71-5, 14 -Day Dose-Range-Finder (similar to OECD 407): NOAEL = 300 mg/kg bw/d ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4081e26-b3a6-497d-ab87-0a81a1b70683/documents/ae28946f-e76a-4bcc-b8b2-c6a657d14c9d_53ee1289-9d75-4d88-81ed-08a7c09e6dcb.html,,,,,, "4-Ethoxy-2,3-difluorphenylboronic acid",212386-71-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4081e26-b3a6-497d-ab87-0a81a1b70683/documents/ae28946f-e76a-4bcc-b8b2-c6a657d14c9d_53ee1289-9d75-4d88-81ed-08a7c09e6dcb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "4-Ethoxy-2,3-difluorphenylboronic acid",212386-71-5, The LD50 value for the test item is expected to be between 300 - 2000 mg/kg bw after single oral administration in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4081e26-b3a6-497d-ab87-0a81a1b70683/documents/cd4a4709-814e-4adf-88c6-d4d9cc272a40_53ee1289-9d75-4d88-81ed-08a7c09e6dcb.html,,,,,, "4-Ethoxy-2,3-difluorphenylboronic acid",212386-71-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4081e26-b3a6-497d-ab87-0a81a1b70683/documents/cd4a4709-814e-4adf-88c6-d4d9cc272a40_53ee1289-9d75-4d88-81ed-08a7c09e6dcb.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "4-ethoxy-4'-(trans-4-ethylcyclohexyl)-2,3-difluoro-1,1'-biphenyl",323178-01-4,"The LD50 value of the test item is higher than 2000 mg/kg bw after single oral administration in rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The guideline and GLP conform study is of sufficient quality to address the endpoint. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32436d23-77db-4974-ad2c-16c65947c456/documents/7371a427-6909-4124-a01a-b73cebfea16e_81472967-ab62-4bef-97e3-6ebd7151e239.html,,,,,, "4-ethoxy-4'-(trans-4-ethylcyclohexyl)-2,3-difluoro-1,1'-biphenyl",323178-01-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32436d23-77db-4974-ad2c-16c65947c456/documents/7371a427-6909-4124-a01a-b73cebfea16e_81472967-ab62-4bef-97e3-6ebd7151e239.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4-Ethoxy-4'-ethyl-2,3-difluoro-1,1'-biphenyl",1175133-14-8, GLP compliant OECD 423: LD50 (oral) > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b42ada55-b29f-4300-ae07-b5fa46ec97a5/documents/cba8814f-af72-4df2-bc2d-eef3efd7f841_d8b8a74c-01b8-4dbc-a617-3c9d894dd9b0.html,,,,,, "4-Ethoxy-4'-ethyl-2,3-difluoro-1,1'-biphenyl",1175133-14-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b42ada55-b29f-4300-ae07-b5fa46ec97a5/documents/cba8814f-af72-4df2-bc2d-eef3efd7f841_d8b8a74c-01b8-4dbc-a617-3c9d894dd9b0.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 4-ethoxybenzoic acid,619-86-3, Acute oral toxicity: LD50 was estimated to be 5058 mg/kg bw when Wistar male rats were orally exposed with 4-Ethoxybenzoic Acid. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6590d09-64c7-4c10-b215-aac86b87d143/documents/195a80bd-6f36-4a31-830f-89394fa0ef1e_e70d4f01-842e-49bf-bdad-9d7a5d426d45.html,,,,,, 4-ethoxybenzoic acid,619-86-3,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6590d09-64c7-4c10-b215-aac86b87d143/documents/195a80bd-6f36-4a31-830f-89394fa0ef1e_e70d4f01-842e-49bf-bdad-9d7a5d426d45.html,,oral,LD50,"5,058 mg/kg bw",no adverse effect observed, "4''-Ethyl-2',3,4,5-tetrafluor-1,1':4',1''-terphenyl",326894-55-7," OECD 423 (rat, oral) LD 50 > 2000 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd1c9f3b-fef4-4fb9-b5bb-337266cca770/documents/c1322029-8403-4deb-b029-10ad862d1791_a9c28648-b100-4e92-8b64-ac8ce9e5f03b.html,,,,,, "4''-Ethyl-2',3,4,5-tetrafluor-1,1':4',1''-terphenyl",326894-55-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd1c9f3b-fef4-4fb9-b5bb-337266cca770/documents/c1322029-8403-4deb-b029-10ad862d1791_a9c28648-b100-4e92-8b64-ac8ce9e5f03b.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4-Ethyl-2',3'-difluor-4''-propyl-1,1':4',1''-terphenyl",157248-25-4," Executive Summary on repeat dose toxicity studies with 4-Ethyl-2',3'-difluor-4''-propyl-1,1':4',1''-terphenyl The repeat dose toxicity of 4-Ethyl-2',3'-difluor-4''-propyl-1,1':4',1''-terphenyl was determined in two subacute studies (OECD 407, rat, 28d, oral administration) and in a reproductive screening assay performed in rats (OECD 421, oral) (1,2). In the first subacute study, daily oral administration of 100, 300 or 1000 mg/kg of 4-Ethyl-2',3'-difluor-4''-propyl-1,1':4',1''-terphenyl to rats for 4 weeks was clinically tolerated with no mortality, clinical signs, changes of body weight, food and water consumption, and no effect on hematology and clinical chemistry parameters in weeks 5 and 7. However, in histopathology, moderate to massive vacuolation and degeneration in the zona fasciculate of the adrenal gland at all dose levels was observed with a comparable degree. Females were more affected than males and control animals did not show any incidence. In the ovary, mild to massive cytoplasmic vacuolation of interstitial cells was detected in all rats of all treatment groups. There was no clear dose-dependency referring to the severity of this finding. No signs of reversibility were discernable after the 2-week treatment free period in the 1000 mg/kg group. Concerning the degeneration and necrosis of single cells in the adrenal cortex, the severity was slightly increased. In a second subacute study a daily oral administration of 3, 10, and 30 mg of 4-Ethyl-2',3'-difluor-4''-propyl-1,1':4',1''-terphenyl/kg to rats for 28 days was clinically tolerated with no mortality, clinical signs, changes of body weight, or relevant changes of food consumption. In histopathology, female rats showed dose-dependent vacuolation in the adrenal cortex and vacuolation of interstitial cells of the ovary were observed down to the lowest dose of 3 mg/kg bw, where still one out of five females was affected. Males were not affected and controls did not show incidences. No signs of reversibility were discernable after the 2-week treatment free period. With respect to severity, cytoplasmic vacuolation of the Zona fasciculata was more pronounced than in the main kill females at 30 mg/kg, as 2 animals exhibited a marked degree. In addition, two females showed a minimal to mild degeneration/ necrosis of inner cortical cells which was not seen in main kill animals. In the ovaries findings were comparable to main kill rats. Cytoplasmic vacuoles in the adrenal cortex are often indicative for an early degenerative lesion and might reflect impaired steroidogenesis, resulting in excess storage of non-metabolized steroid precursors (3). A variety of lipophilic substances can cause this impaired steroidogenesis. For the ovary, it is also described that inhibition of the synthesis of steroid hormones may allow the accumulation of lipids in the ovarian stromal cell cytoplasm to give rise to histological appearances of fatty change (4). However,there exist also other factors such as spontaneous, age-related changes (especially in rats) or stress from various causes that could spontaneously attribute to the cortical vacuolization (5). To assess possible functional impairment on fertility and development caused by the effects seen in the subacute studies, a reproductive screening assay was performed in rats (6). In this assay, 4-Ethyl-2',3'-difluor-4''-propyl-1,1':4',1''-terphenyl was administered daily at 1, 3, and 10 mg/kg bw for a treatment period up to 63 days, i.e. during 14 days of pre-mating and maximum 14 days of mating in both males and females, during the gestation period and up to post-natal day 12 in females. In males, no clinical signs were observed in any treatment group or control animals during the entire study period. In females, isolated incidences of alopecia in one control and one MD group female and slight piloerection in one MD and one HD female were observed for very few days and therefore were considered to be incidental. None of the females showed signs of abortion or premature delivery. There were no test item treatment related effect on body weight, body weight gain, and food consumption observed in the dose groups during the study period. In males and females, there were no statistically significant differences in the absolute and relative organ weights of the dose groups when compared to the control group. There were no biologically significant effects on fertility and reproductive parameters. At necropsy, few specific macroscopic changes were recorded for the male and female animals, which were not considered to be of test item treatment relevance based on microscopic examination. Under the conditions of this study, the test item caused no histological changes indicating toxicity in adrenal glands and reproductive organs based on the pathology evaluation. In the control group, cortical vacuolation was observed in 8 of 10 males and 3 of 10 females with minimal to mild incidence. In the HD group (10 mg/kg bw), 6 of 10 males and 4 of 10 females showed minimal to mild vacuolation. Thus, vacuolation in the adrenal cortex was considered to be not test item related. There were no incidences for necrosis or degeneration in the adrenal gland noted after 63 days oral exposure. Overall the results obtained in the reproductive screening assay clearly demonstrate that there was no functional impairment of the adrenal glands on fertility and development in rats (male/female) at 10 mg/kg bw/day after 63 days of treatment (6). Male rats did not show any effect in the subacute studies up to 30 mg/kg bw (2). Taking all these data into account, the NO(A)EL for female rats at 10 mg/kg bw/day and the NOEL for male rats at 30 mg/kg bw are fully justified based on the finding of the mild necrosis found in two females at 30 mg/kg bw/day 2 weeks after end of treatment. References 1.  4 week oral toxicity study in rats plus a 2 week treatment-free recovery period, 2012 2.      4 week oral toxicity study in rats plus a 2 week treatment-free recovery period, 2013 3.          Capen CC, DeLellis RA, Yarrington JT. Adrenal Cortex. In: Haschek and Rousseaux’s handbook of toxicologic pathology. Third Edition. Amsterdam; Boston: Academic Press; 2013. p. 690–2. 4.          Greaves P. Histopathology of preclinical toxicity studies: interpretation and relevance in drug safety studies. 4th ed. Amsterdam ; Boston: Elsevier/AP; 2012. 886 p. 5.          NTP. Adrenal Gland, Cortex - Vacuolization, Cytoplasmic. In: Nonneoplastic Leasion Atlas [Internet]. [cited 2017 Aug 31]. Available from: https://ntp.niehs.nih.gov/nnl/endocrine/adrenal/cxvacuol/index.htm 6.    4 week oral toxicity study in rats plus a 2 week treatment-free recovery period, 2017   ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/428f1891-924e-475f-9749-a77134618f07/documents/e7640789-f85e-4139-af32-843e8ef6d51b_9264dded-0d48-4ff8-a3cb-024ffce7fd00.html,,,,,, "4-Ethyl-2',3'-difluor-4''-propyl-1,1':4',1''-terphenyl",157248-25-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/428f1891-924e-475f-9749-a77134618f07/documents/e7640789-f85e-4139-af32-843e8ef6d51b_9264dded-0d48-4ff8-a3cb-024ffce7fd00.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "4-Ethyl-2',3'-difluor-4''-propyl-1,1':4',1''-terphenyl",157248-25-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/428f1891-924e-475f-9749-a77134618f07/documents/13c97d02-6815-4604-a527-cc7348374d94_9264dded-0d48-4ff8-a3cb-024ffce7fd00.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4'-Ethyl-2,3-difluorbiphenyl-4-boronic acid",1123312-95-7," The information for this endpoint study record was obtained from an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 422. In this study tubulopathy correlated with increased kidneys weights and grossly visible enlarged kidneys and was considered to be of adverse nature. Predominantly, morbidity and mortality of the adult males and females in this study was considered to be related to the observed tubulopathy. No adverse effects of the test item were noted at a dose level of 25 mg/kg body weight/day. Thus, the NOAEL for general systemic toxicity as well as for developmental toxicity could be established at 25 mg/kg body weight/day. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f35010be-29bc-45dd-8286-99b9357f3238/documents/d695e26b-fa93-4dfe-a916-1e79c3455a23_8326efc7-ade0-4f18-91f7-4ea1abcac142.html,,,,,, "4'-Ethyl-2,3-difluorbiphenyl-4-boronic acid",1123312-95-7,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f35010be-29bc-45dd-8286-99b9357f3238/documents/d695e26b-fa93-4dfe-a916-1e79c3455a23_8326efc7-ade0-4f18-91f7-4ea1abcac142.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat "4'-Ethyl-2,3-difluorbiphenyl-4-boronic acid",1123312-95-7," OECD 423: 300 -2000 mg/kg bw The subsequent evaluation on the necessity of a acute test via a second route was done in accordance with Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance, Version 6.0, July 2017, p 374f. A DermWin calculation shows a dermally absorbed dose of 4.8*10^-5 to 0.00049 mg/cm2/event. Based on the very low dermally absorbed rate and the absence of systemic effects after (sub)acute oral administration, a study on acute dermal toxicity is not required. Furthermore, based on the lack of systemic toxicity after (sub)acute oral adminsitration, it is more than evident that an acute study on inhalation would not show any different outcome. Therefore, and due to animal welfare reasons a study on acute inhalation is not required. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f35010be-29bc-45dd-8286-99b9357f3238/documents/af472382-74a0-41e7-8fe1-61edf2e0e27d_8326efc7-ade0-4f18-91f7-4ea1abcac142.html,,,,,, "4'-Ethyl-2,3-difluorbiphenyl-4-boronic acid",1123312-95-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f35010be-29bc-45dd-8286-99b9357f3238/documents/af472382-74a0-41e7-8fe1-61edf2e0e27d_8326efc7-ade0-4f18-91f7-4ea1abcac142.html,,oral,LD50,300 mg/kg bw,adverse effect observed, 4-Ethyl-2’-fluoro-4’-bromobiphenyl,116713-40-7, GLP compliant OECD 423: LD50 (oral) > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b5fcc73-3415-413f-8b65-a4e3fc4872a1/documents/e672cf14-e220-4e74-84f5-402b9ebff0f9_dc320f5d-daa2-46a3-a0a6-760085c48738.html,,,,,, 4-Ethyl-2’-fluoro-4’-bromobiphenyl,116713-40-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b5fcc73-3415-413f-8b65-a4e3fc4872a1/documents/e672cf14-e220-4e74-84f5-402b9ebff0f9_dc320f5d-daa2-46a3-a0a6-760085c48738.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4''-Ethyl-2'-fluor-4-propyl-1,1':4',1''-terphenyl",95759-44-7, Acute Toxicity oral: OECD 423: LD50 > 2000 mg/kg bw Acute Toxicity inhalative: no information Acute Toxicity dermal: OECD 402: LD50 > 2000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6821515f-c420-4757-8d02-512a58b91172/documents/5d9d76d5-d19d-46de-aee1-fdd71072b4ed_caa22a71-15e1-4d5a-b88a-6bf5f97736cc.html,,,,,, "4''-Ethyl-2'-fluor-4-propyl-1,1':4',1''-terphenyl",95759-44-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6821515f-c420-4757-8d02-512a58b91172/documents/5d9d76d5-d19d-46de-aee1-fdd71072b4ed_caa22a71-15e1-4d5a-b88a-6bf5f97736cc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4''-Ethyl-2'-fluor-4-propyl-1,1':4',1''-terphenyl",95759-44-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6821515f-c420-4757-8d02-512a58b91172/documents/5d9d76d5-d19d-46de-aee1-fdd71072b4ed_caa22a71-15e1-4d5a-b88a-6bf5f97736cc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4'-Ethyl-3-fluorbiphenyl-4-boronic acid,900796-46-5, For this endpoint a one-to-one read across was performed to a chemical similar compound of the same chemical class with a comparable phys. chem. profile and similar response in biological assays. The relevant study was performed according to GLP and the methods applied are fully compliant with OECD TG 422. In the study for the source compound a NOAEL of 25 mg/kg was established. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a7cda15-8e6f-45c7-80a5-6555b57d4cff/documents/99a94b75-bdc6-414c-a39c-86e5e5c401bc_17146660-c916-4555-b8fe-4c489d4f59df.html,,,,,, 4'-Ethyl-3-fluorbiphenyl-4-boronic acid,900796-46-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a7cda15-8e6f-45c7-80a5-6555b57d4cff/documents/99a94b75-bdc6-414c-a39c-86e5e5c401bc_17146660-c916-4555-b8fe-4c489d4f59df.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat 4'-Ethyl-3-fluorbiphenyl-4-boronic acid,900796-46-5," Acute toxicity was studied after oral administration as default route. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 423. The test material was not harmful showing an LD50 > 2000 mg/kg bw. Dermal or inhalative exposure is unlikely based on the assessment of the physicochemical data, e.g. vapour pressure and dermal penetration.as calculated from logP and water solubility. Therefore, further testing for acute dermal of inhalative toxicity is not deemed necessary. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a7cda15-8e6f-45c7-80a5-6555b57d4cff/documents/f4b6e45b-0609-4a7b-80b2-3dbb3aebc7a0_17146660-c916-4555-b8fe-4c489d4f59df.html,,,,,, 4'-Ethyl-3-fluorbiphenyl-4-boronic acid,900796-46-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a7cda15-8e6f-45c7-80a5-6555b57d4cff/documents/f4b6e45b-0609-4a7b-80b2-3dbb3aebc7a0_17146660-c916-4555-b8fe-4c489d4f59df.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 4-ethylmorpholine,100-74-3,"Repeated dose toxicity: oralA repeated dose toxicity with N-ethylmorpholine was performed in rat according to OECD guideline 407 (GLP-compliant). A NOAEL of 200 mg/kg bw/d was derived based on toxicologically relevant adverse effects like clinical observations, decreased body weight gain, organ weight and histopathology.Repeated dose toxicity: inhalationNo reliable studies were available for this route of exposure. No further testing is needed since a reliable study is available for repeated toxicity via the oral route (REACH Regulation, column 2 adaptation, Annex VIII). Repeated dose toxicity: dermalNo reliable studies were available for this route of exposure. No further testing is needed since a reliable study is available for repeated toxicity via the oral route (REACH Regulation, column 2 adaptation, Annex VIII). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d8814a5-4b2c-4935-b288-988763b620f0/documents/d55158f2-8ba2-42e6-adf2-94ae0da1d2be_90ffe687-7453-4af4-9e3b-44529ed7c06e.html,,,,,, 4-ethylmorpholine,100-74-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d8814a5-4b2c-4935-b288-988763b620f0/documents/d55158f2-8ba2-42e6-adf2-94ae0da1d2be_90ffe687-7453-4af4-9e3b-44529ed7c06e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat 4-ethylmorpholine,100-74-3,Acute toxicity: oral:A K1 acute oral toxicity test with NEM was performed in male and female rats according to OECD Guideline 401. The LD50 was determined to be between 1500-2000 mg/kg bw (males). Therefore the substance was determined to be classified as acute oral category 4 toxicant. Acute toxicity: dermal:A K1 acute dermal toxicity test with NEM was performed in male and female New Zealand White rabbits according to a guideline similar to OECD Guideline 402. The dermal LD50 for NEM was determined to be 1980 mg/kg.Therefore the substance was determined to be classified as acute dermal category 4 toxicant. Acute toxicity: inhalation:No study was performed. An acute inhalation study is not performed as key studies with administration via two other routes was performed. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d8814a5-4b2c-4935-b288-988763b620f0/documents/364cad3b-9f8c-4c1d-b828-b2f0621509fd_90ffe687-7453-4af4-9e3b-44529ed7c06e.html,,,,,, 4-ethylmorpholine,100-74-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d8814a5-4b2c-4935-b288-988763b620f0/documents/364cad3b-9f8c-4c1d-b828-b2f0621509fd_90ffe687-7453-4af4-9e3b-44529ed7c06e.html,,oral,LD50,"1,500 mg/kg bw",adverse effect observed, 4-ethylmorpholine,100-74-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d8814a5-4b2c-4935-b288-988763b620f0/documents/364cad3b-9f8c-4c1d-b828-b2f0621509fd_90ffe687-7453-4af4-9e3b-44529ed7c06e.html,,dermal,LD50,"1,980 mg/kg bw",no adverse effect observed, "4-fluoro-1,3-dioxolan-2-one",114435-02-8, A reliable OECD 407 study is available conducted in accordance with GLP. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd70e1bd-2d84-437a-8826-c60e8fa912fa/documents/52b9e5a7-5c01-4b28-8047-b3b14d8a5820_b234e33b-398d-48da-88bc-0ddf37719db9.html,,,,,, "4-fluoro-1,3-dioxolan-2-one",114435-02-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd70e1bd-2d84-437a-8826-c60e8fa912fa/documents/52b9e5a7-5c01-4b28-8047-b3b14d8a5820_b234e33b-398d-48da-88bc-0ddf37719db9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "4-fluoro-1,3-dioxolan-2-one",114435-02-8, Reliable acute toxicity studies via the oral and dermal routes of exposure are available conducted in accordance with OECD guidelines and GLP. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd70e1bd-2d84-437a-8826-c60e8fa912fa/documents/b7ed8823-2c07-410a-8986-3346b7f1912e_b234e33b-398d-48da-88bc-0ddf37719db9.html,,,,,, "4-fluoro-1,3-dioxolan-2-one",114435-02-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd70e1bd-2d84-437a-8826-c60e8fa912fa/documents/b7ed8823-2c07-410a-8986-3346b7f1912e_b234e33b-398d-48da-88bc-0ddf37719db9.html,,oral,LD50,500 mg/kg bw,adverse effect observed, 4-fluoroaniline,371-40-4,"Read-across approach to structural analogue substance 3,5 -Difluoroaniline (CAS 372 -39 -4) was used. In the conducted combined repeated dose toxicity study with the reproduction/ developmental toxicity screening test, the NOAEL(rat) for systemic toxicity was determined to be 10 mg/kg bw. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd588615-caf8-470d-ad84-a1cdaf8f24d7/documents/IUC5-9e9e65ec-e72d-4542-9c5e-83f7fb4bb837_d75e0152-7a72-436c-989a-152916f90c16.html,,,,,, 4-fluoroaniline,371-40-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd588615-caf8-470d-ad84-a1cdaf8f24d7/documents/IUC5-9e9e65ec-e72d-4542-9c5e-83f7fb4bb837_d75e0152-7a72-436c-989a-152916f90c16.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat 4-fluoroaniline,371-40-4,"AOT: In Okazaki et al. the TDLo was determined to be 600 mg/kg bw.ADT: Read –across approach to structural analogue substance 3,5-difluoroaniline (CAS 372-39-4) was used. The LD50 acute dermal toxicity in rat was determined to be > 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd588615-caf8-470d-ad84-a1cdaf8f24d7/documents/IUC5-4a3eddc9-c14c-4a77-b0c7-664cdfd0f5a3_d75e0152-7a72-436c-989a-152916f90c16.html,,,,,, 4-fluoroaniline,371-40-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd588615-caf8-470d-ad84-a1cdaf8f24d7/documents/IUC5-4a3eddc9-c14c-4a77-b0c7-664cdfd0f5a3_d75e0152-7a72-436c-989a-152916f90c16.html,,oral,discriminating dose,600 mg/kg bw,no adverse effect observed, 4-fluoroaniline,371-40-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd588615-caf8-470d-ad84-a1cdaf8f24d7/documents/IUC5-4a3eddc9-c14c-4a77-b0c7-664cdfd0f5a3_d75e0152-7a72-436c-989a-152916f90c16.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3-(2-{4-[(Z)-(2,4-DIFLUOROPHENYL)(HYDROXYIMINO)METHYL]PIPERIDIN-1-YL}ETHYL)-2-METHYL-6,7,8,9-TETRAHYDRO-4H-PYRIDO[1,2-A]PYRIMIDIN-4-ONE",132961-05-8,"Acute toxicity: Oral In an acute oral toxicity study in female Wistar rats, following the acute toxic class method in a method similar to the OECD Guideline 401 (Megens; 1992), the LD50 of T001624 was established to be 85.7 mg/kg bw for males and females (LD50 males = 113 mg/kg bw; LD50 females = 65 mg/kg bw). T001624 was found to be moderately toxic by the oral route and should be classified as Category 3 according to CLP regulation (EC) No 1272/2008.   In an acute oral toxicity study in rats, the LD50 of T001624 was found to be 129.9 mg/kg (Janssen; 1990).   The studies were used in a weight-of-evidence approach.  ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfbfb3dd-d3af-4614-a04a-1eed61de2492/documents/48d8cc68-0f07-469f-9b48-2568338b345d_aa6754d3-be16-4ebd-be7f-40cd30f23ddf.html,,,,,, "3-(2-{4-[(Z)-(2,4-DIFLUOROPHENYL)(HYDROXYIMINO)METHYL]PIPERIDIN-1-YL}ETHYL)-2-METHYL-6,7,8,9-TETRAHYDRO-4H-PYRIDO[1,2-A]PYRIMIDIN-4-ONE",132961-05-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfbfb3dd-d3af-4614-a04a-1eed61de2492/documents/48d8cc68-0f07-469f-9b48-2568338b345d_aa6754d3-be16-4ebd-be7f-40cd30f23ddf.html,,oral,LD50,65.5 mg/kg bw,adverse effect observed, 4-hydroxy-1-methyl-3-[(4-nitrophenyl)azo]-2-quinolone,10114-46-2," The structural analogue substance had a LD50 (oral, gavage) of ca. 6500 mg/kg bw in rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc27f5ea-2fbf-4fd1-b845-a0f8520e6839/documents/9d267974-34de-43b3-bc87-cb4b055a9ed6_15ad7b51-e739-4fd9-a79e-7c62e0f7facf.html,,,,,, 4-hydroxy-1-methyl-3-[(4-nitrophenyl)azo]-2-quinolone,10114-46-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc27f5ea-2fbf-4fd1-b845-a0f8520e6839/documents/9d267974-34de-43b3-bc87-cb4b055a9ed6_15ad7b51-e739-4fd9-a79e-7c62e0f7facf.html,,oral,LD50,"6,500 mg/kg bw",no adverse effect observed, "4-hydroxy-2,2,6,6-tetramethylpiperidine-1-ethanol",52722-86-8,"A 90d oral gavage study in rats revealed only non adverse clinical pathology changes of minor severity and resulted in a NOAEL of 750 mg/kg (highest dose tested). A 28-Day oral toxicity study in rats with the test substance induced mainly local irritancy/inflammatory changes in the GI tract. Based on the outcome, a NOAEL of 300 mg/kg/day was established. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ed030ed-6454-4722-8363-19eceedbda61/documents/IUC5-ecd2f392-1115-4640-b5eb-8cf360bd33e9_58962698-c47b-47bb-847b-feec46020bf4.html,,,,,, "4-hydroxy-2,2,6,6-tetramethylpiperidine-1-ethanol",52722-86-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ed030ed-6454-4722-8363-19eceedbda61/documents/IUC5-ecd2f392-1115-4640-b5eb-8cf360bd33e9_58962698-c47b-47bb-847b-feec46020bf4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "4-hydroxy-2,2,6,6-tetramethylpiperidine-1-ethanol",52722-86-8,"- Oral: LD50 rat > 2000mg/kg (limit test, OECD 401)- Dermal: LD50 rat > 2000 mg/kg (limit test, OECD 402) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ed030ed-6454-4722-8363-19eceedbda61/documents/IUC5-7fea200d-9fe3-4c8b-8cfe-1d0b57a30cf1_58962698-c47b-47bb-847b-feec46020bf4.html,,,,,, "4-hydroxy-2,2,6,6-tetramethylpiperidine-1-ethanol",52722-86-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ed030ed-6454-4722-8363-19eceedbda61/documents/IUC5-7fea200d-9fe3-4c8b-8cfe-1d0b57a30cf1_58962698-c47b-47bb-847b-feec46020bf4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-hydroxy-2,2,6,6-tetramethylpiperidine-1-ethanol",52722-86-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ed030ed-6454-4722-8363-19eceedbda61/documents/IUC5-7fea200d-9fe3-4c8b-8cfe-1d0b57a30cf1_58962698-c47b-47bb-847b-feec46020bf4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-hydroxy-3,5-dimethoxybenzonitrile",72684-95-8," Acute oral and acute dermal toxicity of 4-hydroxy-3,5-dimethoxybenzonitrile were examined in rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/351b0374-1cb6-4cbe-a4f0-5918d44f080d/documents/c146e83a-5a9e-45d6-9b92-307bbc2e58cf_f911f75b-cad1-489e-8e28-ff7a2a9f435c.html,,,,,, "4-hydroxy-3,5-dimethoxybenzonitrile",72684-95-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/351b0374-1cb6-4cbe-a4f0-5918d44f080d/documents/c146e83a-5a9e-45d6-9b92-307bbc2e58cf_f911f75b-cad1-489e-8e28-ff7a2a9f435c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "4-hydroxy-3,5-dimethoxybenzonitrile",72684-95-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/351b0374-1cb6-4cbe-a4f0-5918d44f080d/documents/c146e83a-5a9e-45d6-9b92-307bbc2e58cf_f911f75b-cad1-489e-8e28-ff7a2a9f435c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-hydroxy-6-(3-sulphoanilino)naphthalene-2-sulphonic acid,25251-42-7," Acute oral toxicity LD50 was estimated to be 4719.44mg/kg bw, when Sprague-Dawley rats male and female were exposed with 4-hydroxy-6-[(3-sulfophenyl)amino]naphthalene-2-sulfonic acid (25251-42-7)orally. Acute dermal toxicity LD50 was estimated to be 4309.30mg/kg bw/day.  When male and female New Zealand White rabbits were exposed with 4-hydroxy-6-[(3-sulfophenyl)amino]naphthalene-2-sulfonic acid (25251-42-7) by dermal application. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3241faff-05f8-41b3-bb63-7f9044e7dd46/documents/823aea38-6031-4427-bee3-57710d6c14bf_cf4241c4-ec8b-4821-a5c8-72315c606eea.html,,,,,, 4-hydroxy-6-(3-sulphoanilino)naphthalene-2-sulphonic acid,25251-42-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3241faff-05f8-41b3-bb63-7f9044e7dd46/documents/823aea38-6031-4427-bee3-57710d6c14bf_cf4241c4-ec8b-4821-a5c8-72315c606eea.html,,oral,LD50,"4,719.44 mg/kg bw",no adverse effect observed, 4-hydroxy-6-(3-sulphoanilino)naphthalene-2-sulphonic acid,25251-42-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3241faff-05f8-41b3-bb63-7f9044e7dd46/documents/823aea38-6031-4427-bee3-57710d6c14bf_cf4241c4-ec8b-4821-a5c8-72315c606eea.html,,dermal,LD50,"4,309.3 mg/kg bw",no adverse effect observed, 4-hydroxy-6-(methylamino)naphthalene-2-sulphonic acid,6259-53-6," Acute oral toxicity:  Acute oral toxicity dose (LD50) of 4-hydroxy-6-(methylamino) naphthalene-2-sulfonic acid (CAS no: 6259-53-6) was predicted based on OECD QSAR toolbox 4603 mg/kg bw; Danish (Q)SAR Database 3700 mg/kg bw and different studies available on structurally similar read across substances 6-aminonaphthalene-2-sulphonic acid (CAS No. 93-00-5) >2000 mg/kg bw and Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No: 15790-07-5) >2000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 4-hydroxy-6-(methylamino) naphthalene-2-sulfonic acid cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  4-hydroxy-6-(methylamino) naphthalene-2-sulfonic acid (CAS no: 6259-53-6) has very low vapour pressure (6.99E-009 Pa at 25°C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for 4-hydroxy-6-(methylamino) naphthalene-2-sulfonic acid (CAS no: 6259-53-6) was predicted based on OECD QSAR toolbox 4419 mg/kg bwand differentstudies available for the structurally similar read across substances 6-aminonaphthalene-2-sulphonic acid (CAS No. 93-00-5) >2000 mg/kg bw and Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No: 15790-07-5) >2000 mg/kg bw. All these studies concluded that the LD50 value is>2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 4-hydroxy-6-(methylamino) naphthalene-2-sulfonic acid cannot be classified for acute dermal toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42def8a1-aab8-4c7a-aa2b-6f37c78fd299/documents/541205c6-713e-4729-a81c-9ca2b009aab4_4eff32f7-32c1-4100-a74d-7738a2c26f6f.html,,,,,, 4-hydroxy-6-(methylamino)naphthalene-2-sulphonic acid,6259-53-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42def8a1-aab8-4c7a-aa2b-6f37c78fd299/documents/541205c6-713e-4729-a81c-9ca2b009aab4_4eff32f7-32c1-4100-a74d-7738a2c26f6f.html,,oral,LD50,"4,603 mg/kg bw",no adverse effect observed, 4-hydroxy-6-(methylamino)naphthalene-2-sulphonic acid,6259-53-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42def8a1-aab8-4c7a-aa2b-6f37c78fd299/documents/541205c6-713e-4729-a81c-9ca2b009aab4_4eff32f7-32c1-4100-a74d-7738a2c26f6f.html,,dermal,LD50,"4,419 mg/kg bw",no adverse effect observed, 4-hydroxybenzenesulphonic acid,98-67-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9900a1e3-9800-4e3c-9a6e-48538d176f4b/documents/32c3efef-384b-4064-9447-16b2d37ae513_50ff36a2-2963-4ce6-9b83-4821134d7213.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 4-hydroxybenzenesulphonic acid,98-67-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9900a1e3-9800-4e3c-9a6e-48538d176f4b/documents/243fed0b-9473-4a1a-a7b7-3be7dce18a8f_50ff36a2-2963-4ce6-9b83-4821134d7213.html,,oral,LD50,"1,410 mg/kg bw",no adverse effect observed, 4-hydroxybenzophenone,1137-42-4," In conclusion, based on the interim results of this combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422, performed under GLP conditions), (no raw data was reviewed and no phase reports were available for dose formulation analysis and histopathology), the following no-observed-adverse-effect level (NOAEL) of 4-HYDROXY-BENZOPHENONE were established: Parental NOAEL: 100 mg/kg (based on increased liver weights at 300 mg/kg/day) Reproduction NOAEL: at least 300 mg/kg Developmental NOAEL: at least 300 mg/kg. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2afa0d20-a444-43ea-8799-702afb7a4a8f/documents/32f12400-a36c-44eb-ba2f-b990e64fc17f_8f9ced72-ae54-40c5-b25a-b976357a55c3.html,,,,,, 4-hydroxybenzophenone,1137-42-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2afa0d20-a444-43ea-8799-702afb7a4a8f/documents/32f12400-a36c-44eb-ba2f-b990e64fc17f_8f9ced72-ae54-40c5-b25a-b976357a55c3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 4-hydroxybenzophenone,1137-42-4, Study carried out according to recognised testing guidelines under GLP certification. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2afa0d20-a444-43ea-8799-702afb7a4a8f/documents/39bb45ab-395a-44e1-bc06-7f3ab882baef_8f9ced72-ae54-40c5-b25a-b976357a55c3.html,,,,,, 4-isobutyl-2-methylbenzaldehyde,73206-60-7,The acute oral LD50 was estimated to be 2500 mg/kg bw (OECD 423). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/883ce2a9-8daa-47b1-ae8d-f21d90dcea2d/documents/IUC5-be6aebd6-9a66-428a-8d2e-9e47003d2282_4cb63f7b-1d6f-4036-b93b-bc1037667a8c.html,,,,,, 4-isobutyl-2-methylbenzaldehyde,73206-60-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/883ce2a9-8daa-47b1-ae8d-f21d90dcea2d/documents/IUC5-be6aebd6-9a66-428a-8d2e-9e47003d2282_4cb63f7b-1d6f-4036-b93b-bc1037667a8c.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, 4-isocyanato-2-methyl-1-{4-[(trifluoromethyl)thio]phenoxy}benzene,106310-19-4," Acute oral toxicity: A single oral administration of the test substance by gavage to male and female rats at 200 mg/kg bw and 2000 mg/kg bw was tolerated without mortalities. Transient clinical signs were observed at doses of 200 mg/kg bw and above. There was no effect on body weight gain. The gross pathology investigations performed at the end of the follow-up period did not afford any findings indicative for a specific test compound effect. The LD50 was determined to be > 2000 mg/kg bw in both sexes. Acute inhalation toxicity: The acute inhalation toxicity of the aerolized test item, tested in a GLP-compliant study according to OECD TG 403, is high in rats of both sexes. Lethalities occurred on the day of exposure and, less frequently, during the first observation day. A gender-specific difference in susceptibility to intoxication by inhalation was not be ascertained. The death of the animals was regarded to be causally related to the respiratory tract irritation. The silmultaneous occurence of bradypnea and hypothermia are consistent with an assessment that the substance also induces sensory irritation to the respiratory tract. The LC50 for both sexes combined was calculated to be 348 mg/m³ (4h)./m³. Acute dermal toxicity: A single dermal administration of the test substance to male and female rats at the limit-dose 1310 mg/kg (due to local irritation) was tolerated without mortalities, compound-related clinical findings, effects on body weight gain and gross pathological findings. According to OECD TG 402 the dermal LD50 of the test substance is therefore > 1310 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/432c2059-1818-46fc-b5a7-9ea21b383c5b/documents/8086460d-a383-4691-aed7-48999a7c5433_df267bed-8344-4248-b438-92f37d1f27dd.html,,,,,, 4-isocyanato-2-methyl-1-{4-[(trifluoromethyl)thio]phenoxy}benzene,106310-19-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/432c2059-1818-46fc-b5a7-9ea21b383c5b/documents/8086460d-a383-4691-aed7-48999a7c5433_df267bed-8344-4248-b438-92f37d1f27dd.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 4-isocyanato-2-methyl-1-{4-[(trifluoromethyl)thio]phenoxy}benzene,106310-19-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/432c2059-1818-46fc-b5a7-9ea21b383c5b/documents/8086460d-a383-4691-aed7-48999a7c5433_df267bed-8344-4248-b438-92f37d1f27dd.html,,dermal,discriminating dose,"1,310 mg/kg bw",no adverse effect observed, 4-isocyanato-2-methyl-1-{4-[(trifluoromethyl)thio]phenoxy}benzene,106310-19-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/432c2059-1818-46fc-b5a7-9ea21b383c5b/documents/8086460d-a383-4691-aed7-48999a7c5433_df267bed-8344-4248-b438-92f37d1f27dd.html,,inhalation,LC50,348 mg/m3,adverse effect observed, 4'-methoxyacetoacetanilide,5437-98-9,"KEY STUDY (KEY_401_1997_Inveresk_14820), LD50 female rat (= most sensitive sex): 1755 mg/kg bw ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/841c3df9-2c7d-4cdc-a405-095b41a63ac3/documents/IUC5-1ce5f5c9-248e-498c-82de-6419c3366aa8_a093d295-7325-4853-b46b-c6185b9bc508.html,,,,,, 4'-methoxyacetoacetanilide,5437-98-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/841c3df9-2c7d-4cdc-a405-095b41a63ac3/documents/IUC5-1ce5f5c9-248e-498c-82de-6419c3366aa8_a093d295-7325-4853-b46b-c6185b9bc508.html,,oral,LD50,"1,755 mg/kg bw",adverse effect observed, "(6R,7R)-3-chloromethyl-7-{(Z)-2-(5-amino-1,2,4-thiadiazol-3-yl)2-[(1-carboxy-1-methylethoxy)imino]acetylamino}-8-oxo-5-thia-1-azbicyclo[4.2.0]oct-2-ene-2-carboxylic acid p-methoxybenzyl ester",689294-28-8,Oral NOEL at 13 weeks on rats: 4 mg/kg bw/day. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa54382c-e3f6-4a54-a267-dfe093da2f41/documents/IUC5-afb4efab-6751-46ce-b1cc-1a25d4d10a8c_ac550199-b923-4c6c-b425-284e1d5f8374.html,,,,,, "(6R,7R)-3-chloromethyl-7-{(Z)-2-(5-amino-1,2,4-thiadiazol-3-yl)2-[(1-carboxy-1-methylethoxy)imino]acetylamino}-8-oxo-5-thia-1-azbicyclo[4.2.0]oct-2-ene-2-carboxylic acid p-methoxybenzyl ester",689294-28-8,No acute oral toxicity is expected. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa54382c-e3f6-4a54-a267-dfe093da2f41/documents/IUC5-2f621d88-1a38-40b2-be8f-24db965da5fd_ac550199-b923-4c6c-b425-284e1d5f8374.html,,,,,, 4-methoxy-N-phenyl-o-toluidine,41317-15-1," Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for 4-methoxy-2-methyl-N-phenylaniline. The study assumed the use of male and female Sprague Dawley rats in a 28 days study. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Level (NOAEL) for 4-methoxy-2-methyl-N-phenylaniline is predicted to be 419.804534912 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3dc0850-ee90-40ff-a4c5-c718d07f384e/documents/c8d76932-2566-4307-8e25-b3891af39fa1_9e422eef-0cee-4d7a-9409-acafa9103f90.html,,,,,, 4-methoxy-N-phenyl-o-toluidine,41317-15-1,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3dc0850-ee90-40ff-a4c5-c718d07f384e/documents/c8d76932-2566-4307-8e25-b3891af39fa1_9e422eef-0cee-4d7a-9409-acafa9103f90.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,419.805 mg/kg bw/day,,rat 4-methoxy-N-phenyl-o-toluidine,41317-15-1," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target substance4-methoxy-2-methyl-N-phenylaniline(41317-15-1)was estimated to be 7032.78 mg/kg bw,and for differentstudies available on the structurally similar read across substance 2-methoxynaphthalene (93-04-9) was considered to be >2000 mg/kg bw and >5000 mg/kg bw,for4-(anilino)phenol (122-37-2) was considered to be 3300 mg/kg bw and for 2-Ethoxynaphthalene (93-18-5) was considered to be 5000 mg/kg bw.All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,4-methoxy-2-methyl-N-phenylaniline(41317-15-1) cannot be classified for acute oral toxicity. Acute Inhalation Toxicity:  4-methoxy-2-methyl-N-phenylaniline (41317-15-1)has very low vapour pressure (0.0136 Pa.).So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver. Acute Dermal Toxicity: In Acute dermal toxicity, LD50 value was predicted based on OECD QSAR toolbox for target substance4-methoxy-2-methyl-N-phenylaniline (41317-15-1)was estimated to be 3454.3 mg/kg bw,and for differentstudies available on structurally similar read across substance 2-methoxynaphthalene (93-04-9) was considered to be >2000 mg/kg bw and >5000 mg/kg bw,and for2-Ethoxynaphthalene (93-18-5) was considered to be >2000 mg/kg bw.All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,4-methoxy-2-methyl-N-phenylaniline (41317-15-1)cannot be classified for acute dermal toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3dc0850-ee90-40ff-a4c5-c718d07f384e/documents/25c96843-a51a-4e9e-b029-0270d9adbc2d_9e422eef-0cee-4d7a-9409-acafa9103f90.html,,,,,, 4-methoxy-N-phenyl-o-toluidine,41317-15-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3dc0850-ee90-40ff-a4c5-c718d07f384e/documents/25c96843-a51a-4e9e-b029-0270d9adbc2d_9e422eef-0cee-4d7a-9409-acafa9103f90.html,,oral,LD50,"7,032.78 mg/kg bw",no adverse effect observed, 4-methoxy-N-phenyl-o-toluidine,41317-15-1,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3dc0850-ee90-40ff-a4c5-c718d07f384e/documents/25c96843-a51a-4e9e-b029-0270d9adbc2d_9e422eef-0cee-4d7a-9409-acafa9103f90.html,,dermal,LD50,"3,454.3 mg/kg bw",no adverse effect observed, 4-methoxyphenylacetic acid,104-01-8," The repeated dose toxicity study was predicted using OECD QSAR toolbox version 3.3 (2017) with log kow as the primary descriptor and considering the five closest read across substances; to evaluate the toxic effects of administration of 4-methoxyphenylacetic acid  (CAS No. 104-01-8) in rats by the oral route in a 13 weeks of exposure. No adverse effects were observed. Therefore, the no-observed adverse effect level (NOAEL) of 4-methoxyphenylacetic acid  (CAS No. 104-01-8) was estimated to be 1153.08 mg/kg bw/day (actual dose received). ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0fb30233-9844-4ac2-9307-21198146ee4c/documents/6558d308-2392-4fb7-970b-026b90e8cb8e_f9fea6c4-f0d5-4399-a63c-3d4b82e0177a.html,,,,,, 4-methoxyphenylacetic acid,104-01-8,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0fb30233-9844-4ac2-9307-21198146ee4c/documents/6558d308-2392-4fb7-970b-026b90e8cb8e_f9fea6c4-f0d5-4399-a63c-3d4b82e0177a.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,153.08 mg/kg bw/day",,rat 4-methoxyphenylacetic acid,104-01-8, Acute toxicity – oral LD50 was considered to be > 2000 mg/kg bw and < 5000 mg/kg bw when rat were treated with (4-methoxyphenyl) acetic acid orally. Acute toxicity – dermal LD50 was considered to be > 2000 mg/kg bw when New Zealand White male and female rabbits were treated with 4-methoxyphenylacetic acid under an occlusive wrapping for 24 hours. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fb30233-9844-4ac2-9307-21198146ee4c/documents/IUC5-afc45bb7-7db3-4a93-9b92-ea8d18f7c8c1_f9fea6c4-f0d5-4399-a63c-3d4b82e0177a.html,,,,,, 4-methoxyphenylacetic acid,104-01-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fb30233-9844-4ac2-9307-21198146ee4c/documents/IUC5-afc45bb7-7db3-4a93-9b92-ea8d18f7c8c1_f9fea6c4-f0d5-4399-a63c-3d4b82e0177a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-methoxyphenylacetic acid,104-01-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fb30233-9844-4ac2-9307-21198146ee4c/documents/IUC5-afc45bb7-7db3-4a93-9b92-ea8d18f7c8c1_f9fea6c4-f0d5-4399-a63c-3d4b82e0177a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-methyl-1-phenyl-3-pyrazolidone,2654-57-1," Repeated dose toxicity: Oral The No observed Adverse Effect level (NOAEL) for the test chemical is considered to be 316 mg/Kg bw. Repeated dose toxicity: Inhalation 4-methyl-1-phenyl-3-pyrazolidone (CAS no 2654-57-1) has very low vapor pressure of 5.15E-09 hPa at 25 Deg C, so the potential for the generation of inhalable vapours is very low, also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route of exposure was considered for waiver Repeated dose toxicity: Dermal The acute dermal toxicity value for 4-methyl-1-phenyl-3-pyrazolidone (CAS no 2654-57-1) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b41daf55-05cc-4d0c-b65d-58d209898abe/documents/6be23c0d-6a61-4ee9-84b2-bb0715324a3c_3cb45153-5427-4080-b839-4f7f09e4c5d6.html,,,,,, 4-methyl-1-phenyl-3-pyrazolidone,2654-57-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b41daf55-05cc-4d0c-b65d-58d209898abe/documents/6be23c0d-6a61-4ee9-84b2-bb0715324a3c_3cb45153-5427-4080-b839-4f7f09e4c5d6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,316 mg/kg bw/day,,rat 4-methyl-1-phenyl-3-pyrazolidone,2654-57-1," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is 627 mg/kg bw. The study concluded that the LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.00122 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on study conducted on rats for the given test chemical. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b41daf55-05cc-4d0c-b65d-58d209898abe/documents/ea5caa5e-8e58-42e6-82d2-96784080f847_3cb45153-5427-4080-b839-4f7f09e4c5d6.html,,,,,, 4-methyl-1-phenyl-3-pyrazolidone,2654-57-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b41daf55-05cc-4d0c-b65d-58d209898abe/documents/ea5caa5e-8e58-42e6-82d2-96784080f847_3cb45153-5427-4080-b839-4f7f09e4c5d6.html,,oral,LD50,627 mg/kg bw,adverse effect observed, 4-methyl-1-phenyl-3-pyrazolidone,2654-57-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b41daf55-05cc-4d0c-b65d-58d209898abe/documents/ea5caa5e-8e58-42e6-82d2-96784080f847_3cb45153-5427-4080-b839-4f7f09e4c5d6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-methyl-2-pentan-3-yloxan-4-ol,1099648-69-7," Oral LD50 > 2000 mg/kg bw (OECD 423, K, Rel.2, class method in rats) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/616418a7-7905-4585-8562-261f799d815e/documents/9afe7189-21b9-4297-9870-b7586287115c_b11918e1-51df-4ce2-9b94-9e78d66a2309.html,,,,,, 4-methyl-2-pentan-3-yloxan-4-ol,1099648-69-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/616418a7-7905-4585-8562-261f799d815e/documents/9afe7189-21b9-4297-9870-b7586287115c_b11918e1-51df-4ce2-9b94-9e78d66a2309.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "4-methyl-4'-n-propyl-[1,1-biphenyl]",117713-15-2, GLP compliant OECD 423: LD50 (oral) > 2000 mg/kg bw ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73ca3b74-702c-48ba-b926-d8e817643d52/documents/84546639-a29e-4098-93ca-8ad0095cd6bb_705834d8-915d-4862-8be6-517fe23ec4b8.html,,,,,, "4-methyl-4'-n-propyl-[1,1-biphenyl]",117713-15-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73ca3b74-702c-48ba-b926-d8e817643d52/documents/84546639-a29e-4098-93ca-8ad0095cd6bb_705834d8-915d-4862-8be6-517fe23ec4b8.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 4-methyl-6-phenyl-2-hexanol,72681-01-7," Oral: NOAEL (rat): 1000 mg/kg bw/day ; male/female, OECD TG 407, 2017 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12b7f2b0-8501-4516-bcc1-6c268dd679c1/documents/600b0250-ac19-4494-8480-696561e33272_9d7219b8-0f85-4506-8f5c-a6f15218069f.html,,,,,, 4-methyl-6-phenyl-2-hexanol,72681-01-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12b7f2b0-8501-4516-bcc1-6c268dd679c1/documents/600b0250-ac19-4494-8480-696561e33272_9d7219b8-0f85-4506-8f5c-a6f15218069f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-methyl-6-phenyl-2-hexanol,72681-01-7," Oral: LD50 > 2000 mg/kg bw female rat, OECD TG 420, 2016 Inhalation: LC50 > 5.14 mg/L bw, male/female rat, OECD TG 403, 2018 Dermal: LD50 > 2000 mg/kg bw male/female rat, OECD TG 402, 2016 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12b7f2b0-8501-4516-bcc1-6c268dd679c1/documents/e156c5f0-ab5d-4c93-840f-9f83c5ccbf1e_9d7219b8-0f85-4506-8f5c-a6f15218069f.html,,,,,, 4-methyl-6-phenyl-2-hexanol,72681-01-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12b7f2b0-8501-4516-bcc1-6c268dd679c1/documents/e156c5f0-ab5d-4c93-840f-9f83c5ccbf1e_9d7219b8-0f85-4506-8f5c-a6f15218069f.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 4-methyl-6-phenyl-2-hexanol,72681-01-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12b7f2b0-8501-4516-bcc1-6c268dd679c1/documents/e156c5f0-ab5d-4c93-840f-9f83c5ccbf1e_9d7219b8-0f85-4506-8f5c-a6f15218069f.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 4-methyl-6-phenyl-2-hexanol,72681-01-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12b7f2b0-8501-4516-bcc1-6c268dd679c1/documents/e156c5f0-ab5d-4c93-840f-9f83c5ccbf1e_9d7219b8-0f85-4506-8f5c-a6f15218069f.html,,inhalation,discriminating conc.,"5,140 mg/m3",adverse effect observed, 4-methylcyclohexanone,589-92-4," Oral route A 28-day repeated dose toxicity study in the rat via the oral route was conducted under GLP according to guideline OECD TG 407. Groups of 5 male and 5 female Han Wistar Crl:WI (Han) rats received the test substance at dose levels of 50, 150, and 500 mg/kg/day along with a concurrent control. The animals were observed for general health/mortality and moribundity, as well as clinical signs and functional observations. Body weights, food consumption and motor activities were measured and recorded at pre-determined intervals. Blood samples were collected from all animalsat necropsy to evaluate haematology, coagulation and clinical chemistry parameters. Urine was collected from animals during Week 4 and urinalysis parameters were evaluated. All animals were terminated after completion of 28 days of treatment and underwent a detailed necropsy examination with selected organs weighed. Tissues from the control and high dose groups were subjected to a comprehensive histological examination with the liver being examined from all four dose groups.   There were no premature decedents. Decreased activity, partial closing of the eyes and irregular respiration were noted in all males and females receiving 500 mg/kg/day from approximately Day 1 until Day 10 of the study; however, the duration of the observation decreased over time suggesting a tolerance had developed. Erect fur was also noted in all animals receiving 500 mg/kg/day. These findings correlated with increased ease of handling in all animals and the hunched posture. They also correlated with the piloerection/erect fur and fur staining noted in some males and females receiving 500 mg/kg/day during the functional observation battery. In addition, ploughing and salivation were noted in all animals receiving 150 or 500 mg/kg/day.Overall body weight gain and food consumption was higher in females, but not males, receiving 500 mg/kg/day compared with controls. There were no differences in qualitative or quantitative functional observations or motor activity assessments noted during the neurotoxicity assessment.   Haematology and coagulation parameters and gross pathology findings in males and females were unaffected by administration of the test substance. Alanine aminotransferase (40%) and alkaline phosphatase (50%) were higher in males receiving 150 or 500 mg/kg/day compared with controls. Alanine aminotransferase was up to 140% higher in females receiving 50, 150 or 500 mg/kg/day compared with controls. Clinical chemistry changes were associated with dose-dependent increased liver weights recorded in all treated males and females and centrilobular hepatocyte hypertrophy present in males and females at 500 mg/kg/day. Liver weights were statistically significantly higher for males and females at 150 mg/kg/day and above. Clinical chemistry and liver weight changes in animals at 150 mg/kg/day and below, are not associated with the pathology changes, so considered to be adaptive and non-adverse.   Under the conditions of the study the No Observed Adverse Effect Level (NOAEL) following 28 days of dosing with 4 -methylcyclohexanone was 150 mg/kg/day.  The NOAEL is based on increased body weight in females and decreased activity, irregular respiration and convulsions in males and females at 500 mg/kg/day. In addition centrilobular hepatocyte hypertrophy of the liver with increased liver weights and liver enzymes activity was noted in males and females at 500 mg/kg/day. The study was conducted under GLP according to a guideline method, and was thus assigned a Klimisch reliability rating 1. In accordance with criteria set out in REACH, Annex VIII, 8.6.1, column 2, no further testing is required at this tonnage band.   Inhalation route The repeated dose toxicity via the inhalation route was studied in rabbits in a non-standard, pre-OECD guideline experiment (Treon et al. 1943), which is considered as supporting information due to the methodological deficiencies. Groups of four healthy, young rabbits were exposed whole body to nominal concentrations of 0.82, 2.31, 5.12 or 8.19 mg/L for 6 hours per day, 5 days per week. The test duration was 10 weeks for the two lower concentrations and 3 weeks for the two higher concentrations. No mortality occurred in the study in any of the test groups, and no significant effects on body weight gain or studied haematologic parameters were reported. Exposure to the two higher concentrations resulted in lethargy, distention of the superficial blood vessels in the ear, signs of conjunctival irritation, lacrimation and salivation, whereas exposure to the moderate concentration caused only slight conjunctival irritation and exposure to the lowest concentration did not cause any adverse effects. The gross and microscopic histopathology examination found unspecified signs of vascular injuries and inflammatory response to these injuries. The study was assigned a Klimisch reliability rating 3, and is not considered reliable for the purposes of risk assessment or classification.   Dermal route The repeated dose toxicity via the dermal route was studied in a single young white rabbit in a non-standard, pre-OECD guideline experiment (Treon, 1943), which is considered as supporting information due to the methodological deficiencies. The test substance was applied twice daily at a single fixed dose, separated by 30min before removal, for a period of 6 days. The total dose per day was ca. 3133 mg/kg bw. The animal died 15min after dosing was completed on the sixth day. Effects on heart, liver, kidney and vascular degeneration in the lung were observed, along with narcosis, tremors and convulsions. The study was assigned a Klimisch reliability rating 3, and is not considered adequate or reliable for the purposes of risk assessment or classification.   ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b8f12ea3-8f6c-467e-9b18-1e4b451bb018/documents/144e469e-c02b-4ca8-8702-49ef1ca76d1d_f434b9f7-7593-4771-89a1-297ddcba64fb.html,,,,,, 4-methylcyclohexanone,589-92-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b8f12ea3-8f6c-467e-9b18-1e4b451bb018/documents/144e469e-c02b-4ca8-8702-49ef1ca76d1d_f434b9f7-7593-4771-89a1-297ddcba64fb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat 4-methylcyclohexanone,589-92-4,"Acute Oral Toxicity Four existing studies are available which report acute oral toxicity information. Eastman(1959) reported LD50=400 -3200mg/kg bw in rats, Eastman(1960) reported LD50=800 -1600mg/kg bw in rats, and LD50=1600 -3200mg/kg bw in mice. Treon(1943) reported lethal effects in white rabbits with LDlow=1250mg/kg bw (an LD50 was not determined). Although none of the studies can be considered to be reliable, primarily due to the extremely limited details documented in the reports, the values are considered to be sufficiently consistent for the purposes of classification. As a worst case, the lowest reported LD50 of 400mg/kg bw has been taken for the purposes of classification and risk assessment.   Acute Dermal Toxicity No reliable studies following standard guideline methods for acute dermal toxicity were available. The study by Treon (1943) was not considered reliable due to methodological issues.   Both in-vitro skin corrosion studies according to OECD 430 and 431 gave positive results. As a result, and in accordance with REACH, Annex VIII, 8.5.3, column 2, due to skin corrosiveness of the test substance the study on acute dermal toxicity does not have to be performed.   Acute Inhalation Toxicity No adequate or reliable studies following standard guideline methods for acute inhalation toxicity were available.   Both in-vitro skin corrosion studies according to OECD 430 and 431 gave positive results. As a result, and in accordance with o Regulation (EC) No 1907/2006 (REACH) Annex VIII Item 8.5.3 column 2, due to skin corrosiveness of the test substance the study on acute dermal toxicity does not have to be performed.   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8f12ea3-8f6c-467e-9b18-1e4b451bb018/documents/cdd4d849-9570-4d9c-95c6-792f326508d2_f434b9f7-7593-4771-89a1-297ddcba64fb.html,,,,,, 4-methylcyclohexanone,589-92-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8f12ea3-8f6c-467e-9b18-1e4b451bb018/documents/cdd4d849-9570-4d9c-95c6-792f326508d2_f434b9f7-7593-4771-89a1-297ddcba64fb.html,,oral,LD50,400 mg/kg bw,adverse effect observed, 4-methylmorpholine,109-02-4," Repeated dose toxicity - oral : A reliable study with the related source substance NEM is available (Klimisch 2, according to OECD guideline 407, GLP). A NOAEL of 200 mg/kg bw/d was derived. Repeated dose toxicity - inhalation : One reliable study is available for the inhalation route (Klimisch 2 study). The study (DiPasquale LC, 1979) performed a subacute test according to a method similar or equivalent to OECD guideline 412 (GLP) in which rats were exposed to 100 or 1000 ppm test substance for two weeks. A NOAEC of 100 ppm or 414 mg/m³ air was derived.   Repeated dose toxicity - dermal : No reliable studies were available for this route of exposure. However, no further testing is needed since reliable studies are available for repeated toxicity via the oral and inhalatory route (REACH regulation, Column 2 Adaptation, Annex VIII).   ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ae58792-5baf-4d6e-86ea-a25f56fb45d4/documents/e2ab677d-8795-45b3-92ac-143ab97dd0a7_16ed9cc1-06a6-457f-84fb-b63d4c1b33ac.html,,,,,, 4-methylmorpholine,109-02-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ae58792-5baf-4d6e-86ea-a25f56fb45d4/documents/e2ab677d-8795-45b3-92ac-143ab97dd0a7_16ed9cc1-06a6-457f-84fb-b63d4c1b33ac.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat 4-methylmorpholine,109-02-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ae58792-5baf-4d6e-86ea-a25f56fb45d4/documents/e2ab677d-8795-45b3-92ac-143ab97dd0a7_16ed9cc1-06a6-457f-84fb-b63d4c1b33ac.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,414 mg/m3,,rat 4-methylmorpholine,109-02-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ae58792-5baf-4d6e-86ea-a25f56fb45d4/documents/e2ab677d-8795-45b3-92ac-143ab97dd0a7_16ed9cc1-06a6-457f-84fb-b63d4c1b33ac.html,Repeated dose toxicity – local effects,inhalation,NOAEC,414 mg/m3,adverse effect observed,rat 4-methylmorpholine,109-02-4,"Acute toxicity - oral: A K1 acute oral toxicity test was performed in male and female Sprague Dawley rats according to a guideline similar to OECD Guideline 401 (Mallory VT, 1990). This study was selected as key study.   Acute toxicity - dermal: A K1 acute dermal toxicity test was performed in male and female New Zealand White rabbits according to a guideline similar to OECD Guideline 402 (Mallory VT, 1990). This study was selected as key study. Acute toxicity - inhalation: In a supporting study, BASF (1964) performed an acute inhalation toxicity study equivalent to OECD Guideline 403. Following mortalities were observed: 6/6 rats died when exposed to the saturated vapour of the test substance for 1 hour, 5/6 rats died when exposed to the saturated vapour of the test substance for 30 min and all 12 rats survived when exposed to the saturated vapour of the test substance for 10 min. No LC50 value could be determined. No acute inhalation study is to be performed as the substance is classified as corrosive to the skin. Acute toxicity - other routes: In an acute toxicity study via the intraperitoneal route (single exposure), no animal died in the 184, 368 and 735 mg/kg bw dose groups, 1/10 in the 919 mg/kg bw dose group, 9/10 in the 1149 mg/kg bw dose group and 5/5 in the 1471 mg/kg bw dose group. The LD50 was determined to be situated in the range > 919 - < 1149 mg/kg. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ae58792-5baf-4d6e-86ea-a25f56fb45d4/documents/564db8a4-e733-445b-a0e6-b4623cd79559_16ed9cc1-06a6-457f-84fb-b63d4c1b33ac.html,,,,,, 4-methylmorpholine,109-02-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ae58792-5baf-4d6e-86ea-a25f56fb45d4/documents/564db8a4-e733-445b-a0e6-b4623cd79559_16ed9cc1-06a6-457f-84fb-b63d4c1b33ac.html,,oral,LD50,"1,442.3 mg/kg bw",adverse effect observed, 4-methylmorpholine,109-02-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ae58792-5baf-4d6e-86ea-a25f56fb45d4/documents/564db8a4-e733-445b-a0e6-b4623cd79559_16ed9cc1-06a6-457f-84fb-b63d4c1b33ac.html,,dermal,LD50,"3,000 mg/kg bw",adverse effect observed, 4-Methyl-N-[3-(triethoxysilyl)propyl]-2-pentanimine,116229-43-7, The substance was tested for acute oral toxicity according to OECD TG 423 and under GLP. Two females dosed with a single application of 2000 mg/kg bw were found dead within two hours post-treatment. No further mortality occurred during an observation period of 14 days. A dose of 300 mg/kg bw did not result in any mortalities. The LD50 cut-off (rat) was therefore determined to amount 1000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1efe62f-d8ae-4e11-a4f3-e35720ff473c/documents/aad65e8a-e6f1-4f58-91db-38bbfeb744f3_2c05ba51-0a68-4ef8-a3ba-873a8e228bde.html,,,,,, 4-Methyl-N-[3-(triethoxysilyl)propyl]-2-pentanimine,116229-43-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1efe62f-d8ae-4e11-a4f3-e35720ff473c/documents/aad65e8a-e6f1-4f58-91db-38bbfeb744f3_2c05ba51-0a68-4ef8-a3ba-873a8e228bde.html,,oral,discriminating dose,"1,000 mg/kg bw",adverse effect observed, 4-methylpentan-2-one oxime,105-44-2," Acute toxicity - oral: A key, K2 acute oral toxicity study was performed similar to OECD guideline 402 and compliant to GLP requirements. The LD50 was determined to be 1.5 mL/kg, the highest dose tested. Acute toxicity - dermal/inhalaton: No reliable data is available. This information is not required according to REACH regulation Annex VII. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b759d863-8fb9-48e0-a6dc-bd0f9f835617/documents/f209aab5-ccb3-44dd-a1d9-fdbfd4dc7d3a_e9ea0c2d-5eb5-460f-a3b6-55bc88aca95d.html,,,,,, 4-methylpiperazin-1-amine,6928-85-4, Acute oral toxicity LD50 was estimated to be 2775mg/kg bw when male wistar rats were exposed with 4-Methylpiperazin-1-amine (6928-85-4) orally. Acute dermal toxicity LD50 was estimated to be 3227mg/kg bw when male and female Crl:CD®BR rats were exposed with 4-Methylpiperazin-1-amine (6928-85-4) by dermal application. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c172c831-d59b-46bf-88e6-fdc178f58f3d/documents/ec99f976-bdb7-4985-a9a5-a668eeb42aa9_551c3d7e-fe0f-4cf9-84fa-0ea9bb7f5adb.html,,,,,, 4-methylpiperazin-1-amine,6928-85-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c172c831-d59b-46bf-88e6-fdc178f58f3d/documents/ec99f976-bdb7-4985-a9a5-a668eeb42aa9_551c3d7e-fe0f-4cf9-84fa-0ea9bb7f5adb.html,,oral,LD50,"2,775 mg/kg bw",no adverse effect observed, 4-methylpiperazin-1-amine,6928-85-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c172c831-d59b-46bf-88e6-fdc178f58f3d/documents/ec99f976-bdb7-4985-a9a5-a668eeb42aa9_551c3d7e-fe0f-4cf9-84fa-0ea9bb7f5adb.html,,dermal,LD50,"3,227 mg/kg bw",no adverse effect observed, 4-methylpyridine,108-89-4,"Acute oral toxicity: Weight of evidence: Experimental results from studies performed with the analogue substances piperidine and pyridine. Results of both studies showed that the LD50 in rats is between 300 and 2000 mg/kg bw which leads to a classification of category 4 according to CLP Regulation EC No. 1272/2008. Based on these results, the read-across approach was applied and 4-methylpyridine can be also considered classified as acute oral toxicity category 4 according to CLP Regulation EC No. 1272/2008. Acute inhalation toxicity: Weight of evidence: Experimental results from studies performed with the analogue substances piperidine, pyridine and 2-methylpyridine. Most of results from these studies showed that the 4-hour LC50 in rats was over 2000 ppm and less than or around 4000 ppm which leads to a classification that straddles the border between category 3 and category 4 according to CLP Regulation EC No. 1272/2008. Based on these results, the read-across approach was applied and 4-methylpyridine could be also considered between category 3 and category 4. However, 4-methylpyridine is considered classified as acute inhalation toxicity category 4 according to the harmonized classification (Annex VI of CLP Regulation (EC) No 1272/2008). Acute dermal toxicity: Key study. Test method similar to EPA OPPTS 870.1200. The dermal LD50 of 4-methylpyridine in rabbits was 0.27 ml/kg or 260 mg/kg. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Weight of evidence of two studies with Klimisch score = 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Weight of evidence of several studies with Klimisch score = 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Key study with Klimisch score = 2 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/306edca0-8a8f-4f96-a226-7bb25a31586c/documents/75495768-1eb9-4c94-a207-18696b9edf20_3c28b856-6455-457f-b118-6ec49aed1b7b.html,,,,,, 4-methylpyridine,108-89-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/306edca0-8a8f-4f96-a226-7bb25a31586c/documents/75495768-1eb9-4c94-a207-18696b9edf20_3c28b856-6455-457f-b118-6ec49aed1b7b.html,,oral,LD50,487 mg/kg bw,adverse effect observed, 4-methylpyridine,108-89-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/306edca0-8a8f-4f96-a226-7bb25a31586c/documents/75495768-1eb9-4c94-a207-18696b9edf20_3c28b856-6455-457f-b118-6ec49aed1b7b.html,,dermal,LD50,260 mg/kg bw,adverse effect observed, 4-methylpyridine,108-89-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/306edca0-8a8f-4f96-a226-7bb25a31586c/documents/75495768-1eb9-4c94-a207-18696b9edf20_3c28b856-6455-457f-b118-6ec49aed1b7b.html,,inhalation,LC50,"> 2,000 ",adverse effect observed, 4-methylstyrene,622-97-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91b5a601-aac4-425a-bda0-544abaeb668e/documents/c72d227e-18eb-4183-a96c-f6908db6f714_8bb67925-993f-4c23-8bf2-13ed613b5b90.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,50 mg/kg bw/day,,rat 4-methylstyrene,622-97-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91b5a601-aac4-425a-bda0-544abaeb668e/documents/c72d227e-18eb-4183-a96c-f6908db6f714_8bb67925-993f-4c23-8bf2-13ed613b5b90.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,290.04 mg/m3,,rat 4-methylstyrene,622-97-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91b5a601-aac4-425a-bda0-544abaeb668e/documents/50dc011f-3a9f-47e8-8c52-842f3c43aa8c_8bb67925-993f-4c23-8bf2-13ed613b5b90.html,,oral,LD50,"3,375 mg/kg bw",adverse effect observed, 4-methylstyrene,622-97-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91b5a601-aac4-425a-bda0-544abaeb668e/documents/50dc011f-3a9f-47e8-8c52-842f3c43aa8c_8bb67925-993f-4c23-8bf2-13ed613b5b90.html,,dermal,LD50,"4,585 mg/kg bw",no adverse effect observed, 4-methylstyrene,622-97-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91b5a601-aac4-425a-bda0-544abaeb668e/documents/50dc011f-3a9f-47e8-8c52-842f3c43aa8c_8bb67925-993f-4c23-8bf2-13ed613b5b90.html,,inhalation,LC50,"16,891 mg/m3",adverse effect observed, 4-methylthiosemicarbazide,6610-29-3,"Only one repeated study in available : the test item was administered daily for 4 weeks by the oral route to male and female Sprague-Dawley rats at dose-levels of 0.5, 2.5 or 10 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) was considered to be 2.5 mg/kg/day based on effects observed at 10 mg/kg/day on thymus, spleen and bone marrow. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca0410bf-b352-4f91-ab5b-95d891bbd9af/documents/IUC5-34119cf1-a40e-4392-87e8-ad34d69c53a2_38a6008c-31a8-4cf7-b4a0-99b76b60595d.html,,,,,, 4-methylthiosemicarbazide,6610-29-3,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca0410bf-b352-4f91-ab5b-95d891bbd9af/documents/IUC5-34119cf1-a40e-4392-87e8-ad34d69c53a2_38a6008c-31a8-4cf7-b4a0-99b76b60595d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,2.5 mg/kg bw/day,,rat 4-methylthiosemicarbazide,6610-29-3,"Acute toxicity of MTSC was evaluated in two reliable studies : by oral and dermal route.MTSC is toxic by oral route with a LD50 of 15 mg/kg bw on rats (Nelson 1978), and toxic by dermal route with a LD50 comprised between 200 and 1000 mg/kg in rats (Petitpretz 2012). ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca0410bf-b352-4f91-ab5b-95d891bbd9af/documents/IUC5-5c057e45-498b-469c-a0ff-bd6059e550ca_38a6008c-31a8-4cf7-b4a0-99b76b60595d.html,,,,,, 4-methylthiosemicarbazide,6610-29-3,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca0410bf-b352-4f91-ab5b-95d891bbd9af/documents/IUC5-5c057e45-498b-469c-a0ff-bd6059e550ca_38a6008c-31a8-4cf7-b4a0-99b76b60595d.html,,oral,LD50,15 mg/kg bw,adverse effect observed, 4-methylthiosemicarbazide,6610-29-3,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca0410bf-b352-4f91-ab5b-95d891bbd9af/documents/IUC5-5c057e45-498b-469c-a0ff-bd6059e550ca_38a6008c-31a8-4cf7-b4a0-99b76b60595d.html,,dermal,LD50,200 mg/kg bw,adverse effect observed, "2,2-dimethyl-3-(morpholin-4-yl)propanal",23588-51-4, For the acute oral toxicity study with the test item in rats the determined LD50 is greater than 2000 mg/kg bw (LD50 > 2000 mg/kg bw). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fa32aef-45b1-463f-8afa-55cb71b141f5/documents/d333446c-855f-4255-8657-7ff3d384a63b_0a0db70c-8bfe-42f4-813f-018a6dfda2ee.html,,,,,, "2,2-dimethyl-3-(morpholin-4-yl)propanal",23588-51-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fa32aef-45b1-463f-8afa-55cb71b141f5/documents/d333446c-855f-4255-8657-7ff3d384a63b_0a0db70c-8bfe-42f4-813f-018a6dfda2ee.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 4-nitro-3-(trifluoromethyl)aniline,393-11-3," The acute oral toxicity of the test item 2-Nitro-5-amino bentsotrifluoride ( 4-Nitro-3-(trifluoromethyl)aniline) was evaluated in female Sprague Dawley rats according to OECD 423, EC 2008/440/EC B.1 tris, US EPA OPPTS 870.1100 guidelines and in compliance with GLP. The test substance induced mortality in the rat following oral administration of a single dose at levels of 2000 and 300 mg/kg. Main clinical sings after 2000 mg/kg were reduced activity, ataxia and moribund status and after 300 mg/kg reduced activity, lethargy, prone posture and moribund status. Gross pathology examination showed abnormal colour and/or abnormal contents in the parts of Gastrointestinal track, Abdominal cavity, Cranial cavity and Thoracic cavity at dose 2000 mg/kg. At 300 mg/kg dose decedent animals showed yellow stainign of the urogenital region. No mortality or other relevant signs of toxicity were observed following dosing at 50 mg/kg. The results suggest the LD50 to be greater than 50 mg/kg but lower than 300 mg/kg bw and indicate the classification of Acute Oral Toxicity Category 3. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d08480c-7f0e-4428-8c9c-fca28e941bf6/documents/1fdd5d9b-9d0b-44c4-8683-e60cd55a4709_1bacf88b-ce2d-4758-af29-9c6abefbc8ff.html,,,,,, 4-nitro-3-(trifluoromethyl)aniline,393-11-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d08480c-7f0e-4428-8c9c-fca28e941bf6/documents/1fdd5d9b-9d0b-44c4-8683-e60cd55a4709_1bacf88b-ce2d-4758-af29-9c6abefbc8ff.html,,oral,LD50,300 mg/kg bw,adverse effect observed, 4-nitroaniline,100-01-6,The substance 4-nitroaniline do not show any repeated dose toxicity. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/744f60e8-7493-4ce6-aee7-f6c2ba7d74f5/documents/IUC5-72ead8c1-9ed5-4aa1-9b2b-4af955948b03_1aca1ca3-8ef0-40d3-8d11-3ab3d30ae84c.html,,,,,, 4-nitroaniline,100-01-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/744f60e8-7493-4ce6-aee7-f6c2ba7d74f5/documents/IUC5-72ead8c1-9ed5-4aa1-9b2b-4af955948b03_1aca1ca3-8ef0-40d3-8d11-3ab3d30ae84c.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,10 mg/m3,,rat 4-nitroaniline,100-01-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/744f60e8-7493-4ce6-aee7-f6c2ba7d74f5/documents/IUC5-72ead8c1-9ed5-4aa1-9b2b-4af955948b03_1aca1ca3-8ef0-40d3-8d11-3ab3d30ae84c.html,Chronic toxicity – systemic effects,oral,,"2,700 mg/kg bw/day",,rat 4-nitroaniline,100-01-6,"Though the supporting studies for acute oral toxicity for 4-nitroaniline indicate toxicity category IV, since 4-nitroaniline has a harmonized classification of acute oral Category III; therefore for the purpose of this dossier and chemical safety assessment the value of the key study shall be used.For acute toxicity by the inhalation route; the key study does not indicate that 4-nitroaniline shall have toxic effect by the inhalation route. However since 4-nitroaniline has a harmonized classification of acute inhalation Category III; this dossier agrees to the harmonized classification though a key study is not available supporting the classification. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/744f60e8-7493-4ce6-aee7-f6c2ba7d74f5/documents/IUC5-0ba144e1-381d-4c75-90bd-f32db5a56a31_1aca1ca3-8ef0-40d3-8d11-3ab3d30ae84c.html,,,,,, 4-nitroaniline,100-01-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/744f60e8-7493-4ce6-aee7-f6c2ba7d74f5/documents/IUC5-0ba144e1-381d-4c75-90bd-f32db5a56a31_1aca1ca3-8ef0-40d3-8d11-3ab3d30ae84c.html,,oral,LD50,75 mg/kg bw,adverse effect observed, 4-nitroaniline,100-01-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/744f60e8-7493-4ce6-aee7-f6c2ba7d74f5/documents/IUC5-0ba144e1-381d-4c75-90bd-f32db5a56a31_1aca1ca3-8ef0-40d3-8d11-3ab3d30ae84c.html,,dermal,LD50,500 mg/kg bw,adverse effect observed, 4-nitroaniline,100-01-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/744f60e8-7493-4ce6-aee7-f6c2ba7d74f5/documents/IUC5-0ba144e1-381d-4c75-90bd-f32db5a56a31_1aca1ca3-8ef0-40d3-8d11-3ab3d30ae84c.html,,inhalation,LC50,47.485 mg/m3,no adverse effect observed, 4-nitrobenzenesulphonyl chloride,98-74-8," Repeated dose toxicity - oral: In a combined repeated dose toxicity study with reproduction/developmental toxicity screening test, the test substance was administered daily to rats up to a dose level of 100 mg/kg body weight/day (OECD 422; Van Otterdijk, 2018). The NOAEL is established to be at least 100 mg/kg body weight/day. The substance is considered not to be classified as STOT RE according to the CLP Regulation. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/66fb6bce-7eea-4ee7-aeaf-67a7a00bc4da/documents/d7dfda28-875e-47a0-9f9c-fc8c4214c74a_1a890aa3-213c-4aa5-8e41-55d32166ec00.html,,,,,, 4-nitrobenzenesulphonyl chloride,98-74-8,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/66fb6bce-7eea-4ee7-aeaf-67a7a00bc4da/documents/d7dfda28-875e-47a0-9f9c-fc8c4214c74a_1a890aa3-213c-4aa5-8e41-55d32166ec00.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 4-nitrobenzenesulphonyl chloride,98-74-8," - Acute toxicity: oral: In an acute oral toxicity study in female Wistar rats, following the acute toxic class method in accordance with OECD Guideline 423, the LD50 was established to be greater than 2000 mg/kg (van Sas, 2018). - Acute toxicity: inhalation: the study is waived based on the following justification: In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For this substance, a study was considered however not deemed scientifically justified for the dermal route of exposure due to its low potential for a significant rate of absorption through the skin. Based on the fact that the inhalation route of exposure is not considered relevant in the risk assessment for human exposure and the addition of a waiver for the acute dermal toxicity testing, an acute inhalation toxicity study will not be performed. - Acute toxicity: dermal: the study is waived based on the following justification: In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For this substance, an acute dermal toxicity study was performed. Hoewver, the substance was observed to be unstable in the selected vehicle. In addition, this study can be waived based on the fact that the substance does not meet the criteria for classification for acute toxicity or STOT SE by the oral route, and no systemic toxicity is observed in in vivo studies with dermal exposure.     ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66fb6bce-7eea-4ee7-aeaf-67a7a00bc4da/documents/f58610f4-8923-4c1b-9d52-befb8e0927f2_1a890aa3-213c-4aa5-8e41-55d32166ec00.html,,,,,, 4-nitrobenzenesulphonyl chloride,98-74-8,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66fb6bce-7eea-4ee7-aeaf-67a7a00bc4da/documents/f58610f4-8923-4c1b-9d52-befb8e0927f2_1a890aa3-213c-4aa5-8e41-55d32166ec00.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-nitro-o-anisidine,97-52-9,2-Methoxy-4-nitroaniline was tested after dermal and oral treatment of rats. After dermal treatment no adverse effects were observed at a dose of 2000 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57a066be-8ae1-4ec1-b821-156b6c6e2940/documents/IUC5-20478d44-3b50-42de-b3b7-5c838e233840_ad4cd6dd-e421-4259-b674-dcf778dca15c.html,,,,,, 4-nitro-o-anisidine,97-52-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57a066be-8ae1-4ec1-b821-156b6c6e2940/documents/IUC5-20478d44-3b50-42de-b3b7-5c838e233840_ad4cd6dd-e421-4259-b674-dcf778dca15c.html,,oral,LD50,"1,260 mg/kg bw",, 4-nitro-o-anisidine,97-52-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57a066be-8ae1-4ec1-b821-156b6c6e2940/documents/IUC5-20478d44-3b50-42de-b3b7-5c838e233840_ad4cd6dd-e421-4259-b674-dcf778dca15c.html,,dermal,discriminating dose,"2,000 mg/kg bw",, 4-nitro-o-toluidine,99-52-5, LD50 was estimated to be 270 mg/kg bw for mice treated with 2-methyl-4-nitroaniline. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64426619-1494-45ad-bce0-b86e487cb9a9/documents/175ce01a-a257-4786-86c9-888e39e58f77_5b65649a-1cf0-4550-8d52-9f9ea3aa0f5e.html,,,,,, 4-nitro-o-toluidine,99-52-5,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64426619-1494-45ad-bce0-b86e487cb9a9/documents/175ce01a-a257-4786-86c9-888e39e58f77_5b65649a-1cf0-4550-8d52-9f9ea3aa0f5e.html,,oral,LD50,270 mg/kg bw,adverse effect observed, 4-nitrophenyl 2-(methylsulfonyl)acetate,1158363-70-2,"Oral: The study was performed to assess the acute oral toxicity of the test item in the Wistar strain rat according to OECD 423. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg body weight.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): 1 (reliable without restriction) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4af59890-e0e0-4012-a3a9-e26202eab60b/documents/e761fb04-1bad-4362-a77e-44ebc53f7adb_4290f2be-fcfb-4856-ae89-7e955f305e61.html,,,,,, 4-nitrophenyl 2-(methylsulfonyl)acetate,1158363-70-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4af59890-e0e0-4012-a3a9-e26202eab60b/documents/e761fb04-1bad-4362-a77e-44ebc53f7adb_4290f2be-fcfb-4856-ae89-7e955f305e61.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, 4-nitrotoluene,99-99-0,"Acute oral toxicity: LD50, oral, rat: > 2250 mg/kg bw (key, rel.2, OECD 401 eq, pre-GLP); Acute dermal toxicity: LD50, dermal, rat: > 750 mg/kg bw; LD50, dermal, rabbit: > 20,000 mg/kg bwAcute inhalation toxicity: LC50, inhalation, rat: > 851 mg/m³/4h Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): A Klimisch rating of 2 has been applied. The study is pre-GLP but conducted to a relevant OECD test guideline using well-defined scientific procedures, therefore fulfilling the endpoint requirement. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfefe966-cea7-4827-ad3a-0d863385344d/documents/8821d372-2545-4c32-a042-0585de9db7ee_d22cb97b-5595-4862-83a9-be4a3cdecda6.html,,,,,, 4-nitrotoluene,99-99-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfefe966-cea7-4827-ad3a-0d863385344d/documents/8821d372-2545-4c32-a042-0585de9db7ee_d22cb97b-5595-4862-83a9-be4a3cdecda6.html,,oral,LD50,"> 2,250 mg/kg bw",no adverse effect observed, 4-nitrotoluene-2-sulphonic acid,121-03-9,NOAEL (oral; sub-chronic; rat) = 250 mg/kg bw/ day ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45f4839d-cdc4-486d-9969-f09ad4b1b10a/documents/IUC5-663f12f6-87e5-4ce4-ab3d-cd2d287e6fd4_1771d29a-7486-41af-868f-3f05afbf8993.html,,,,,, 4-nitrotoluene-2-sulphonic acid,121-03-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45f4839d-cdc4-486d-9969-f09ad4b1b10a/documents/IUC5-663f12f6-87e5-4ce4-ab3d-cd2d287e6fd4_1771d29a-7486-41af-868f-3f05afbf8993.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 4-nitrotoluene-2-sulphonic acid,121-03-9,"LD50 (acute oral, rats)> 300 < 2000 mg/kg b.w. LD50 (acute dermal, rats) > 2000 mg/kg b.w. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45f4839d-cdc4-486d-9969-f09ad4b1b10a/documents/IUC5-f27f59c6-3b83-41e3-b735-d215bca1433c_1771d29a-7486-41af-868f-3f05afbf8993.html,,,,,, 4-nitrotoluene-2-sulphonic acid,121-03-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45f4839d-cdc4-486d-9969-f09ad4b1b10a/documents/IUC5-f27f59c6-3b83-41e3-b735-d215bca1433c_1771d29a-7486-41af-868f-3f05afbf8993.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, 4-nitrotoluene-2-sulphonic acid,121-03-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45f4839d-cdc4-486d-9969-f09ad4b1b10a/documents/IUC5-f27f59c6-3b83-41e3-b735-d215bca1433c_1771d29a-7486-41af-868f-3f05afbf8993.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 4-pentylcyclohexanone,61203-83-6, The NOAEL after oral application was determined to be 250 mg/kg bw/day for males and females after 28 days administration to males and female rats. ,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ed9d342-ef95-4e12-affb-6c06d53fb03b/documents/2d7499bf-ab7a-4f72-aa8b-ea37858f63db_78a68310-c25d-4fd5-89bf-ce78b01bbfe6.html,,,,,, 4-pentylcyclohexanone,61203-83-6,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ed9d342-ef95-4e12-affb-6c06d53fb03b/documents/2d7499bf-ab7a-4f72-aa8b-ea37858f63db_78a68310-c25d-4fd5-89bf-ce78b01bbfe6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 4-pentylcyclohexanone,61203-83-6," oral: A study according to OECD TG 401 was performed to determine the acute toxicity of the test item after oral administration to rats. The median lethal dose (LD50 ) for males and females, after an observation period of 15 days, was > 2000 mg/kg bw (reference 7.2.1 -1). dermal: A study according to OECD TG 402 was performed to determine the acute toxicity in rats after epicutaneous administration. The median lethal dose (LD50) for males and females, after an observation period of 15 days, was > 2000 mg/kg (reference 7.2.3-1). ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ed9d342-ef95-4e12-affb-6c06d53fb03b/documents/0a4f99b2-4f77-4370-8172-6c487a0c824d_78a68310-c25d-4fd5-89bf-ce78b01bbfe6.html,,,,,, 4-pentylcyclohexanone,61203-83-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ed9d342-ef95-4e12-affb-6c06d53fb03b/documents/0a4f99b2-4f77-4370-8172-6c487a0c824d_78a68310-c25d-4fd5-89bf-ce78b01bbfe6.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, 4-pentylcyclohexanone,61203-83-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ed9d342-ef95-4e12-affb-6c06d53fb03b/documents/0a4f99b2-4f77-4370-8172-6c487a0c824d_78a68310-c25d-4fd5-89bf-ce78b01bbfe6.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 4-phenoxyphenol,831-82-3," The oral NOAEL (rat, 90 days) for 4-phenoxyphenol is 15 mg/kgbw/day. This NOAEL is based on a read-across approach with Diphenyl Ether. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/241cbedb-2c3b-4463-847b-b38ecbb049ee/documents/b9e58510-c7de-41f6-b517-bbb6290e2261_19f4102c-1a86-42f1-a9f1-9d4faa359905.html,,,,,, 4-phenoxyphenol,831-82-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/241cbedb-2c3b-4463-847b-b38ecbb049ee/documents/b9e58510-c7de-41f6-b517-bbb6290e2261_19f4102c-1a86-42f1-a9f1-9d4faa359905.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat 4-phenoxyphenol,831-82-3," Based on Analogue approach (3 -phenoxyphenol), the oral LD50 is determined to be equal to 1 600 mg/kg bw for 4 -phenoxyphenol. An acute dermal toxicity study performed according to OECD 402 resulted in an LD50 of > 2 000 mg/kg bw. On the basis of the rules for adaptation in Column 2 of the REACH Annex VIII, no inhalation acute toxicity was performed. Furthermore based on the OECD n°110 test showing that the majority of the particule size (92.3%) was between 45 and 125 µm, there is no alveolar fraction and systemic effect after inhalation is not expected. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/241cbedb-2c3b-4463-847b-b38ecbb049ee/documents/2066c32c-eff3-481c-a4db-daa36e98fee8_19f4102c-1a86-42f1-a9f1-9d4faa359905.html,,,,,, 4-phenoxyphenol,831-82-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/241cbedb-2c3b-4463-847b-b38ecbb049ee/documents/2066c32c-eff3-481c-a4db-daa36e98fee8_19f4102c-1a86-42f1-a9f1-9d4faa359905.html,,oral,LD50,"1,600 mg/kg bw",adverse effect observed, 4-phenylbenzophenone,2128-93-0," Based on the results of a reliable combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422) conducted in rats, the No Observed Adverse Effect Levels (NOAELs) of the substance was established to be at least 1000 mg/kg (highest dose employed). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92135db5-6470-46da-a693-979f29312fee/documents/fa2ea568-bb6a-4b8b-81e6-003fc8b12f31_42315c1f-2c21-414e-80e1-7abcb1eede01.html,,,,,, 4-phenylbenzophenone,2128-93-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92135db5-6470-46da-a693-979f29312fee/documents/fa2ea568-bb6a-4b8b-81e6-003fc8b12f31_42315c1f-2c21-414e-80e1-7abcb1eede01.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-phenylbenzophenone,2128-93-0," In a reliable acute oral toxicity study the substance was administered to Wistar rats (3 animals/dose) by oral gavage at a dose level of 2000 mg/kg bw (single administration). The oral LD50 is greater than 2000 mg/kg bw based on no mortalities or signs of clinical toxicity, mean body weight gain was as expected and no abnormalities found at macroscopic post-mortem examination at the end of the 14 day post-dosing observation period. In a reliable acute dermal toxicity study the substance was administered by a single dermal dose to Wistar rats (male/female) at 2000 mg/kg body weight for 24 hours. No mortality occurred. Scales and/or erythema maculate were noted for two females between Days 3 and 10. General erythema, erythema maculate, scales and/or scabs were seen in the treated skin-area of three females during the observation period. The body weight gain was similar to that expected for normal untreated animals of the same age and strain. No abnormalities were found at macroscopic post mortem examination. The dermal LD50 value of the substance in Wistar rats was established to exceed 2000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92135db5-6470-46da-a693-979f29312fee/documents/1113dcc1-8e80-479c-b62f-99db2841b2f4_42315c1f-2c21-414e-80e1-7abcb1eede01.html,,,,,, 4-phenylbenzophenone,2128-93-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92135db5-6470-46da-a693-979f29312fee/documents/1113dcc1-8e80-479c-b62f-99db2841b2f4_42315c1f-2c21-414e-80e1-7abcb1eede01.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-phenylbenzophenone,2128-93-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92135db5-6470-46da-a693-979f29312fee/documents/1113dcc1-8e80-479c-b62f-99db2841b2f4_42315c1f-2c21-414e-80e1-7abcb1eede01.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, 4-propylcyclohexanone,40649-36-3, The NOAEL after oral application was determined to be 250 mg/kg bw/day for males and females after 28 days administration to males and female rats. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff6e6516-4330-415c-946a-a2663f498109/documents/0e0be6d0-5c4f-4e42-8e0b-80b446a3a309_11eb0279-5260-4ef3-b8ba-e838606a0f3c.html,,,,,, 4-propylcyclohexanone,40649-36-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff6e6516-4330-415c-946a-a2663f498109/documents/0e0be6d0-5c4f-4e42-8e0b-80b446a3a309_11eb0279-5260-4ef3-b8ba-e838606a0f3c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat 4-propylcyclohexanone,40649-36-3,"Acute oral toxicity: A study according to OECD TG 401 was performed to determine the acute toxicity of the test item after oral administration to rats. The median lethal dose (LD50) for males and females, after an observation period of 15 days, was > 2000 mg/kg bw. Acute dermal toxicity: A study according to OECD TG 402 was performed to determine the acute toxicity in rats after epicutaneous administration. The median lethal dose (LD50) for males and females, after an observation period of 15 days, was > 2000 mg/kg. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): OECD guideline study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): OECD guideline study ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff6e6516-4330-415c-946a-a2663f498109/documents/15c4e2c2-a2cc-4821-9af7-688392482570_11eb0279-5260-4ef3-b8ba-e838606a0f3c.html,,,,,, 4-propylcyclohexanone,40649-36-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff6e6516-4330-415c-946a-a2663f498109/documents/15c4e2c2-a2cc-4821-9af7-688392482570_11eb0279-5260-4ef3-b8ba-e838606a0f3c.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 4-propylcyclohexanone,40649-36-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff6e6516-4330-415c-946a-a2663f498109/documents/15c4e2c2-a2cc-4821-9af7-688392482570_11eb0279-5260-4ef3-b8ba-e838606a0f3c.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 4-pyridylamine,504-24-5," 4-AP has high acute toxicity to mammals via the oral route of exposure (Category I) and the dermal and inhalation routes of exposure (Category II). The acute and subchronic toxicological effects of 4-AP are manifested as hyperexcitability, hyperirritability, salivation, tremors, and muscular incoordination. 4-AP acts by blocking potassium ion channels in nerve fibers. Adverse effects in humans ingesting low levels of 4-AP (5-30 mg/day) were nervousness, giddiness or dizziness, memory alteration, cramps, arterial vasospasm and peripheral paraesthesia. Higher doses in an accidental poisoning case (one-time estimated dose of 60 mg) produced additional effects including weakness, intense diaphoresis, feeling of impending doom, dyspnea, agitation and combative behavior, and profound thirst. Human studies demonstrated that 4-AP is eliminated quickly from the body and effects did not accumulate with continuous exposure. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a50fe7c-2688-482c-b96c-e1b195b99fbb/documents/3dca6f59-90cd-401c-8c01-6a079ce126f2_911a3d51-0c42-4ea2-a032-fc0cd0449feb.html,,,,,, 4-pyridylamine,504-24-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a50fe7c-2688-482c-b96c-e1b195b99fbb/documents/3dca6f59-90cd-401c-8c01-6a079ce126f2_911a3d51-0c42-4ea2-a032-fc0cd0449feb.html,,oral,LD50,20 mg/kg bw,adverse effect observed, 4-pyridylamine,504-24-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a50fe7c-2688-482c-b96c-e1b195b99fbb/documents/3dca6f59-90cd-401c-8c01-6a079ce126f2_911a3d51-0c42-4ea2-a032-fc0cd0449feb.html,,dermal,LD50,327 mg/kg bw,adverse effect observed, 4-pyridylamine,504-24-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a50fe7c-2688-482c-b96c-e1b195b99fbb/documents/3dca6f59-90cd-401c-8c01-6a079ce126f2_911a3d51-0c42-4ea2-a032-fc0cd0449feb.html,,inhalation,LC50,0.001 mg/m3,adverse effect observed, 4'-sulphamoylacetanilide,121-61-9, Acute oral toxicity: LD50 was estimated to be 4848 mg/kg bw when Wistar female rats were orally exposed with N-(4-sulfamoylphenyl)acetamide. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7318d9cc-37e2-4964-960f-cd14e5d423e4/documents/6dbc7a3b-6bc6-45c6-86cd-3e71cdea00d7_cff55308-c038-4736-9bd1-09fea2df5d83.html,,,,,, 4'-sulphamoylacetanilide,121-61-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7318d9cc-37e2-4964-960f-cd14e5d423e4/documents/6dbc7a3b-6bc6-45c6-86cd-3e71cdea00d7_cff55308-c038-4736-9bd1-09fea2df5d83.html,,oral,LD50,"4,848 mg/kg bw",no adverse effect observed, "4-tert-butyl-3-hydroxy-2,6-xylylacetonitrile",55699-10-0,"An oral LD50 of >2000 mg/kg was determined in an acute oral toxicity study (OECD 423, GLP). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ca5568f-b962-4660-84d4-2cbfc05837b6/documents/IUC5-a85f8814-fac4-42b4-ad70-36825da41974_7db91708-b6a8-4cff-a355-dcde12de3b7b.html,,,,,, 4-tert-butylbenzonitrile,4210-32-6, An acute oral toxicity study with 4-tert-Butylbenzonitrile according to OECD 423 is available. The LD50 (oral) of 4-tert-Butylbenzonitrile is estimated to be higher than 200 mg and less than 500 mg per kg body weight in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d1a2d0f-7233-46d0-b787-2cf008a77d5b/documents/IUC5-0440c4d0-bdbd-4dac-a6dd-dd92cac7adca_0da619a9-a360-4ca9-9cfd-83fff847ecc6.html,,,,,, 4-tert-butylcyclohexyl chloroformate,42125-46-2,"Tert butylchloroformate is toxic via the inhalative route of exposure (R23;acute inhal. Cat 3). A LC50 value of >0.72 - < 0.88 mg/l/4h for tert-Butylcyclohexyl-chlorformate aerosol was determined. 4-tert.-butylcyclohexyl chlorformiate is practically non toxic via the oral and dermal rout of exposure as LD50 values ar >6700 mg/kg, >2000 mg/kg, respectively. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a771368c-0110-442f-a448-cb8fc3cb5e95/documents/IUC5-8aad4345-b462-47fb-9fd5-ddb681d8e50f_99ea77b3-aea7-4c75-b013-b860762bf8ea.html,,,,,, "(2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide",89786-04-9, Acute toxicity: Oral Key study: Standard acute method. The LD50 in rats was > 5000 mg/kg-bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ef28b83-fce2-4478-8298-78252c560262/documents/IUC5-6d069f02-4f1a-441d-9aaf-3e6715e8b5b3_38f27fde-11ab-421d-ac6f-7e099347ab04.html,,,,,, "(2S,3S,5R)-3-methyl-7-oxo-3-(1H-1,2,3-triazol-1-ylmethyl)-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid 4,4-dioxide",89786-04-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ef28b83-fce2-4478-8298-78252c560262/documents/IUC5-6d069f02-4f1a-441d-9aaf-3e6715e8b5b3_38f27fde-11ab-421d-ac6f-7e099347ab04.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 4-trans-(4-trans-Propylcyclohexyl)-cyclohexancarbonic acid,65355-32-0,"Based on the result of this study, it is concluded that the test material has no acute toxic potential up to the limit dose of 2000 mg/kg bw. Therefore, the LD50 value is higher than 2000 mg/kg bw after single oral administration in rats (reference 7.2.1 -1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Data are considered reliable to cover this endpoint ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6722b8e7-004b-4270-96fd-dca8a98962bf/documents/ae71da55-973f-459f-aa2a-166e51993044_6885e9ea-88f4-4a96-861b-17103b143c42.html,,,,,, 4-trans-(4-trans-Propylcyclohexyl)-cyclohexancarbonic acid,65355-32-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6722b8e7-004b-4270-96fd-dca8a98962bf/documents/ae71da55-973f-459f-aa2a-166e51993044_6885e9ea-88f4-4a96-861b-17103b143c42.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4'-trans-Butyl-[1,1'-bicyclohexyl]-4-on",92413-47-3," The acute toxicity of the test item was investigated in an acute toxicity study on rats. The test animals showed no clinical signs (and no mortality) up to the limit dose after oral administration. Hence, the LD50 is above 2000 mg/Kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2502e0e5-e53d-4f93-ba84-16be0f4956c4/documents/ea76cdfb-a09d-4047-9d2c-6f72f1c09986_44e80816-978e-45fa-ba8f-b4fb71e64cbb.html,,,,,, "4'-trans-Butyl-[1,1'-bicyclohexyl]-4-on",92413-47-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2502e0e5-e53d-4f93-ba84-16be0f4956c4/documents/ea76cdfb-a09d-4047-9d2c-6f72f1c09986_44e80816-978e-45fa-ba8f-b4fb71e64cbb.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4-trans-Butyl-4'-trans-propyl-[1,1'-bicyclohexyl]",96624-52-1," Based on the results of this study, a dose level of 100 mg/kg/day is established as NOAEL (no-observed-adverse-effect-level) and 30 mg/kg bw is the NOEL  (no-observed-effect-level) for the test material. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b8c4c50f-76a7-46f2-a070-b2da557468f6/documents/4d4615b1-967c-4e86-8076-cb1c8555f58c_ab11b5a5-4f6f-4cdc-b90d-f351dca0b261.html,,,,,, "4-trans-Butyl-4'-trans-propyl-[1,1'-bicyclohexyl]",96624-52-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b8c4c50f-76a7-46f2-a070-b2da557468f6/documents/4d4615b1-967c-4e86-8076-cb1c8555f58c_ab11b5a5-4f6f-4cdc-b90d-f351dca0b261.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "4-trans-Butyl-4'-trans-propyl-[1,1'-bicyclohexyl]",96624-52-1," The acute toxicity of the test item was investigated in an acute toxicity study on rats. The test animals showed no clinical signs (and no mortality) up to the limit dose after oral administration. Hence, the LD50 is above 2000 mg/Kg bw. The subsequent evaluation on the necessity of a acute test via a second route was done in accordance with Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance, Version 6.0, July 2017, p 374f. A DermWin calculation shows a dermally absorbed dose of 3.2*10 -6 to 3.3 -10 -5 mg/cm2/event. Based on the very low dermally absorbed rate and the absence of systemic effects after acute oral administration, a study on acute dermal toxicity is not required. Furthermore, based on the lack of systemic toxicity after acute oral adminsitration, it is more than evident that an acute study on inhalation would not show any different outcome. Therefore, and due to animal welfare reasons a study on acute inhalation is not required. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8c4c50f-76a7-46f2-a070-b2da557468f6/documents/IUC5-8d45ce65-9cbe-4e5a-ad10-87828c5df022_ab11b5a5-4f6f-4cdc-b90d-f351dca0b261.html,,,,,, "4-trans-Butyl-4'-trans-propyl-[1,1'-bicyclohexyl]",96624-52-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8c4c50f-76a7-46f2-a070-b2da557468f6/documents/IUC5-8d45ce65-9cbe-4e5a-ad10-87828c5df022_ab11b5a5-4f6f-4cdc-b90d-f351dca0b261.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4-trans-ethyl-4'-trans-propyl-[1,1'-bicyclohexyl]",96624-41-8, The NOAEL of the test item was determined to be 300 mg/kg bw/day in rats orally administerd for consecutive 28 days (OECD 407 Guideline). ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c9df4c5-9fec-4c0a-9307-f193fd75f78b/documents/IUC5-5fbd9b13-8bdb-461b-9a5c-86add2c6ad15_c5d75a9a-7215-46da-9181-51ccdda359af.html,,,,,, "4-trans-ethyl-4'-trans-propyl-[1,1'-bicyclohexyl]",96624-41-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c9df4c5-9fec-4c0a-9307-f193fd75f78b/documents/IUC5-5fbd9b13-8bdb-461b-9a5c-86add2c6ad15_c5d75a9a-7215-46da-9181-51ccdda359af.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "4-trans-ethyl-4'-trans-propyl-[1,1'-bicyclohexyl]",96624-41-8," RA OECD 423: LD50 > 2000 mg/kg bw (rat, oral) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c9df4c5-9fec-4c0a-9307-f193fd75f78b/documents/IUC5-81ad955f-388b-4744-b5ba-7bf598e58ba8_c5d75a9a-7215-46da-9181-51ccdda359af.html,,,,,, "4-trans-ethyl-4'-trans-propyl-[1,1'-bicyclohexyl]",96624-41-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c9df4c5-9fec-4c0a-9307-f193fd75f78b/documents/IUC5-81ad955f-388b-4744-b5ba-7bf598e58ba8_c5d75a9a-7215-46da-9181-51ccdda359af.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4-trans-Methoxy-4-trans-propyl-[1,1-bicyclohexyl]",97398-80-6, The acute oral LD50 was greater than 5000 mg/kg bw according to an OECD TG 401 compliant study in the rat (reference 7.2.1 -1). ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14b0f332-5676-424c-9dda-ff253668c1d0/documents/IUC5-43b2bdeb-0217-4ae2-80e4-cc077c6ed25c_b503b369-91a2-49bb-abea-f7dd59546749.html,,,,,, "4-trans-Methoxy-4-trans-propyl-[1,1-bicyclohexyl]",97398-80-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14b0f332-5676-424c-9dda-ff253668c1d0/documents/IUC5-43b2bdeb-0217-4ae2-80e4-cc077c6ed25c_b503b369-91a2-49bb-abea-f7dd59546749.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "4'-trans-pentyl-[1,1'-bicyclohexyl]-4-one",84868-02-0," No mortality was observed in the limit test. The median lethal dose (LD50) for males and females, after an observation period of 15 days, was determined to be > 2000 mg/kg (reference 7.2-1). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d5496ee-2c47-4470-9924-4e89f2067ab0/documents/0f9f34a6-d858-42d4-8013-02a8aab00074_92e3b46b-839f-465e-b42a-fdc0ede8fdc4.html,,,,,, "4'-trans-pentyl-[1,1'-bicyclohexyl]-4-one",84868-02-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d5496ee-2c47-4470-9924-4e89f2067ab0/documents/0f9f34a6-d858-42d4-8013-02a8aab00074_92e3b46b-839f-465e-b42a-fdc0ede8fdc4.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4-trans-Pentyl-4'-trans-propyl-[1,1'-bicyclohexyl]",92263-41-7," The NOAEL was 100 mg/kg bw/day as determined in subacute repeated dose toxicity study according to OECD Guideline 407. The doses 300 and 1000 mg/kg were not tolerated by the male rats and proved to be toxic for the female rats because of premature death especially at 1000 mg/kg, effects on body weight, reduced food consumption, changes in behavioral parameters, influence on a few clinicochemical parameters and histopathological organ lesions.. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/683d402e-c3e7-4a5a-b8a3-de80e6d9281f/documents/51a57b48-4a62-4a81-b39e-1f50edf49e94_b26ac7f8-b6fa-4c80-8102-faaf5247e90a.html,,,,,, "4-trans-Pentyl-4'-trans-propyl-[1,1'-bicyclohexyl]",92263-41-7,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/683d402e-c3e7-4a5a-b8a3-de80e6d9281f/documents/51a57b48-4a62-4a81-b39e-1f50edf49e94_b26ac7f8-b6fa-4c80-8102-faaf5247e90a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "4-trans-Pentyl-4'-trans-propyl-[1,1'-bicyclohexyl]",92263-41-7," The oral LD50 value of the test item was determined to be greater than 2000 mg/kg bw in rats. Based on a category approach, the dermal LD50 value of the test item is considered to be greater than 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/683d402e-c3e7-4a5a-b8a3-de80e6d9281f/documents/IUC5-47c6640a-7ec4-4e0b-b315-32ce0de4a390_b26ac7f8-b6fa-4c80-8102-faaf5247e90a.html,,,,,, "4-trans-Pentyl-4'-trans-propyl-[1,1'-bicyclohexyl]",92263-41-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/683d402e-c3e7-4a5a-b8a3-de80e6d9281f/documents/IUC5-47c6640a-7ec4-4e0b-b315-32ce0de4a390_b26ac7f8-b6fa-4c80-8102-faaf5247e90a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-trans-Pentyl-4'-trans-propyl-[1,1'-bicyclohexyl]",92263-41-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/683d402e-c3e7-4a5a-b8a3-de80e6d9281f/documents/IUC5-47c6640a-7ec4-4e0b-b315-32ce0de4a390_b26ac7f8-b6fa-4c80-8102-faaf5247e90a.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 4-trans-propenylveratrole,6379-72-2," Repeated dose toxicity oral: NOAEL = 264 mg/kg bw/day in female rats;  NOAEL = 275 mg/kg bw/day in male rats (similar to OECD 407, K, rel. 2). No adverse effect reported at the highest dose level tested in this study. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3d16470-ad43-4d68-aaba-bb4e2fc7313a/documents/IUC5-2e87c7c2-ac12-4aa6-b20c-cb3ae2b48ed5_da0a5ea6-290a-431c-b2de-1eb22b8574d9.html,,,,,, 4-trans-propenylveratrole,6379-72-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3d16470-ad43-4d68-aaba-bb4e2fc7313a/documents/IUC5-2e87c7c2-ac12-4aa6-b20c-cb3ae2b48ed5_da0a5ea6-290a-431c-b2de-1eb22b8574d9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,264 mg/kg bw/day,,rat 4-trans-propenylveratrole,6379-72-2," Acute toxicity: oral: LD50 = 2500 mg/kg bw (similar to OECD 401 in rats, read-across, K, rel.2); Acute toxicity: dermal: LD50 > 5000 mg/kg bw (similar to OECD 402, read-across, K, rel. 2); Acute toxicity: inhalation: waiver. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3d16470-ad43-4d68-aaba-bb4e2fc7313a/documents/IUC5-6f806c0b-6b07-4de7-a7b1-704bdd6a26e8_da0a5ea6-290a-431c-b2de-1eb22b8574d9.html,,,,,, 4-trans-propenylveratrole,6379-72-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3d16470-ad43-4d68-aaba-bb4e2fc7313a/documents/IUC5-6f806c0b-6b07-4de7-a7b1-704bdd6a26e8_da0a5ea6-290a-431c-b2de-1eb22b8574d9.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, 4-trans-propenylveratrole,6379-72-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3d16470-ad43-4d68-aaba-bb4e2fc7313a/documents/IUC5-6f806c0b-6b07-4de7-a7b1-704bdd6a26e8_da0a5ea6-290a-431c-b2de-1eb22b8574d9.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "4'-trans-propyl-1,1'-bicyclohexyl-4-trans-carboxaldehyde",104358-16-9," Key, rat, OECD 423, GLP, limit test: LD50 > 2000 mg/kg bw/d ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78ee47fe-d25f-48b7-942c-547a9ae8b9eb/documents/fa858694-e357-4890-af01-02adf1d42d6c_3c760465-a2eb-4f9d-9dd5-bcad4f3d2611.html,,,,,, "4'-trans-propyl-1,1'-bicyclohexyl-4-trans-carboxaldehyde",104358-16-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78ee47fe-d25f-48b7-942c-547a9ae8b9eb/documents/fa858694-e357-4890-af01-02adf1d42d6c_3c760465-a2eb-4f9d-9dd5-bcad4f3d2611.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4-trans-Propyl-4-trans-(3,4,5-trifluorphenyl)-[1,1-bicyclohexyl]",131819-23-3, The informtion for this endpoint study record was obtained from an experimental study. The OECD GLP criteria were met and the methods applied are fully compliant with OECD TG 401. The LD50 value was determined to be greater than 5000 mg/kg bw. ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1061374-4af4-4c8a-88e7-b1a7b042e77b/documents/273d3735-392a-47be-bf7f-8eb1bffcb05e_9b1c1d1b-9da8-4e24-932f-287926937384.html,,,,,, "4-trans-Propyl-4-trans-(3,4,5-trifluorphenyl)-[1,1-bicyclohexyl]",131819-23-3,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1061374-4af4-4c8a-88e7-b1a7b042e77b/documents/273d3735-392a-47be-bf7f-8eb1bffcb05e_9b1c1d1b-9da8-4e24-932f-287926937384.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, 4-vinylpyridine,100-43-6,"Several repeated dose oral toxicity studies in rats on a 4VP analogue, 2VP, are available which suggest a systemic NOAEL between 20 and 50 mg/kg bw/d. There is no evidence of specific target organ toxicity; only signs of minor toxicity such as changes in food consumption, altered body weight gain, and changes in relative organ weights. Concerning local effects, 2VP displayed corrosive effects at the portal of entry, the nonglandular stomach. The LOAEL for this effect was 20 mg/kg bw/d in the 90-day study. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a9217d5-9c63-481d-ab5b-f3f413398f93/documents/2afaf9c7-8069-4ff3-9e22-ffb30a2d8219_5e0379ae-1fc5-4ac5-9606-e8b59d4a213c.html,,,,,, 4-vinylpyridine,100-43-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a9217d5-9c63-481d-ab5b-f3f413398f93/documents/2afaf9c7-8069-4ff3-9e22-ffb30a2d8219_5e0379ae-1fc5-4ac5-9606-e8b59d4a213c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat 4-vinylpyridine,100-43-6,The oral LD50 is between 100 and 200 mg/kg body weight (bw); the inhalatory LC50 value is between 1000 and 2000 ppm; and the dermal LD50 is less than 500 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a9217d5-9c63-481d-ab5b-f3f413398f93/documents/9952ef7f-abaf-4054-ad33-d5bb4a3ca3ae_5e0379ae-1fc5-4ac5-9606-e8b59d4a213c.html,,,,,, 4-vinylpyridine,100-43-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a9217d5-9c63-481d-ab5b-f3f413398f93/documents/9952ef7f-abaf-4054-ad33-d5bb4a3ca3ae_5e0379ae-1fc5-4ac5-9606-e8b59d4a213c.html,,oral,LD50,100 mg/kg bw,adverse effect observed, 4-vinylpyridine,100-43-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a9217d5-9c63-481d-ab5b-f3f413398f93/documents/9952ef7f-abaf-4054-ad33-d5bb4a3ca3ae_5e0379ae-1fc5-4ac5-9606-e8b59d4a213c.html,,dermal,LD50,500 mg/kg bw,adverse effect observed, 4-vinylpyridine,100-43-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a9217d5-9c63-481d-ab5b-f3f413398f93/documents/9952ef7f-abaf-4054-ad33-d5bb4a3ca3ae_5e0379ae-1fc5-4ac5-9606-e8b59d4a213c.html,,inhalation,LC50,"4,300.2 mg/m3",adverse effect observed, "5-(4-hydroxyphenyl)imidazolidine-2,4-dione",2420-17-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e777448e-a90a-48bd-afbe-99023a7b74f5/documents/IUC5-144ba701-7c05-4122-acfe-ab63c4512079_e28d4a6e-0af5-4373-a71c-c8ca56077ae4.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 5-(aminosulphonyl)-N-[(1-ethyl-2-pyrrolidinyl)methyl]-2-methoxybenzamide monohydrochloride,23694-14-6, No adverse effects were observed after subacute and subchronic levosulpiride administration. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b3e435d-3fdc-4a95-b480-03983299e9f5/documents/1ceb4a85-86ef-4c82-8667-a027f011f649_977915fd-2faf-4d10-86f1-2d4af26584ff.html,,,,,, 5-(aminosulphonyl)-N-[(1-ethyl-2-pyrrolidinyl)methyl]-2-methoxybenzamide monohydrochloride,23694-14-6, LD50 values for several animal species are available in the scientific literature. Those values are almost all higher than 2000 mg/kg (a LD50 of 1700 mg/kg bw also is reported for mouse). ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b3e435d-3fdc-4a95-b480-03983299e9f5/documents/bb105893-a867-449c-8895-1cefd93a56d3_977915fd-2faf-4d10-86f1-2d4af26584ff.html,,,,,, 5-(aminosulphonyl)-N-[(1-ethyl-2-pyrrolidinyl)methyl]-2-methoxybenzamide monohydrochloride,23694-14-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b3e435d-3fdc-4a95-b480-03983299e9f5/documents/bb105893-a867-449c-8895-1cefd93a56d3_977915fd-2faf-4d10-86f1-2d4af26584ff.html,,oral,LD50,"6,000 mg/kg bw",adverse effect observed, "5-(benzoylamino)-4-hydroxy-3-[[1-sulpho-6-[[2-(sulphooxy)ethyl]sulphonyl]-2-naphthyl]azo]naphthalene-2,7-disulphonic acid, sodium salt",85586-40-9,Substance is practically non-toxic ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/847fe4e5-8bec-4f77-af96-0373340797bb/documents/IUC5-c3667308-7901-40a3-a0f3-3cef60849fba_cfa5e334-abb4-48c2-a9ce-354e3a8cda18.html,,,,,, "5-(benzoylamino)-4-hydroxy-3-[[1-sulpho-6-[[2-(sulphooxy)ethyl]sulphonyl]-2-naphthyl]azo]naphthalene-2,7-disulphonic acid, sodium salt",85586-40-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/847fe4e5-8bec-4f77-af96-0373340797bb/documents/IUC5-c3667308-7901-40a3-a0f3-3cef60849fba_cfa5e334-abb4-48c2-a9ce-354e3a8cda18.html,,oral,LD50,"9,246 mg/kg bw",no adverse effect observed, "5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium acetate",83969-14-6, Acute oral toxicity LD50 (male) = 395 mg/kg bw. LD50 (female) = 275 mg/kg bw. Acute dermal toxicity LD0 = 2000 mg(kg LD50 > 2000 mg/kg ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fb71e21-8307-4d7a-9247-3200b9a45540/documents/a84bcd03-a86f-42a9-bd84-788db9231a31_478d8962-8de7-4756-ae3a-a935dc5d53f1.html,,,,,, "5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium acetate",83969-14-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fb71e21-8307-4d7a-9247-3200b9a45540/documents/a84bcd03-a86f-42a9-bd84-788db9231a31_478d8962-8de7-4756-ae3a-a935dc5d53f1.html,,oral,LD50,275 mg/kg bw,adverse effect observed, "5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium methyl sulphate",83969-12-4," Based on the results of the 28-day oral toxicity study, it can be concluded that the histopathological alterations observed in kidneys and liver of male animals treated at the high dose level (40 mg/kg body weight/day) were adaptive changes and showed a complete reversibility at the end of the recovery period. Hence, the dose level of 40 mg/kg body weight/day was considered to be the No Observed Adverse Effect Level (NOAEL) in this study. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5f3621b9-ec97-4a8c-bc89-c4f5d3453897/documents/fe4590f7-cf77-41d6-bfe3-73825e7d891e_c272f857-bc7e-46a7-829a-c2ead5f20bbe.html,,,,,, "5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium methyl sulphate",83969-12-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5f3621b9-ec97-4a8c-bc89-c4f5d3453897/documents/fe4590f7-cf77-41d6-bfe3-73825e7d891e_c272f857-bc7e-46a7-829a-c2ead5f20bbe.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat "5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium methyl sulphate",83969-12-4," In the acute oral toxicity study in rats, signs of unspecific toxicity were observed at dose levels of 100 to 800 mg/kg bw. The oral LD50 for males and females together was calculated to be 216 mg/kg bw (CI 172 to 272 mg/kg bw) based on test material. This calculated to 124 mg/kg bw for the active ingredient. No toxicity was obderved in the acute dermal toxicity study, leading to a dermal LD50 of above 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f3621b9-ec97-4a8c-bc89-c4f5d3453897/documents/d767400b-2c9d-4a64-b629-486e889677a4_c272f857-bc7e-46a7-829a-c2ead5f20bbe.html,,,,,, "5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium methyl sulphate",83969-12-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f3621b9-ec97-4a8c-bc89-c4f5d3453897/documents/d767400b-2c9d-4a64-b629-486e889677a4_c272f857-bc7e-46a7-829a-c2ead5f20bbe.html,,oral,LD50,124 mg/kg bw,adverse effect observed, "5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium trichlorozincate(1-)",93783-70-1," Repeated dose oral toxicity study in rats dosed for 4 weeks, followed by 2 weeks of recovery: NOAEL = 40 mg/kg/day, equivalent to ca. 35 mg/kg a.i. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4401836-7727-4756-95ea-19f4cb2cc752/documents/a2c23d9a-91e4-47ee-b875-4f4b56df9419_f7eb07e0-2a71-413e-a734-bb5d8023f868.html,,,,,, "5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium trichlorozincate(1-)",93783-70-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4401836-7727-4756-95ea-19f4cb2cc752/documents/a2c23d9a-91e4-47ee-b875-4f4b56df9419_f7eb07e0-2a71-413e-a734-bb5d8023f868.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,35 mg/kg bw/day,,rat "5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium trichlorozincate(1-)",93783-70-1," Acute oral toxicity LD50 (male) = 395 mg/kg, equivalent to 177.8 mg/kg a.i.. LD50 (female) = 275 mg/kg, equivalent to 124 mg/kg a.i.. Acute dermal toxicity LD0 = 2000 mg/kg, equivalent to 1732 mg/kg a.i. LD50 > 2000 mg/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4401836-7727-4756-95ea-19f4cb2cc752/documents/cdc637ca-fd30-45a1-b3ab-6b0f2b48cccd_f7eb07e0-2a71-413e-a734-bb5d8023f868.html,,,,,, "5-(diisopropylamino)-2-[[4-(dimethylamino)phenyl]azo]-3-methyl-1,3,4-thiadiazolium trichlorozincate(1-)",93783-70-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4401836-7727-4756-95ea-19f4cb2cc752/documents/cdc637ca-fd30-45a1-b3ab-6b0f2b48cccd_f7eb07e0-2a71-413e-a734-bb5d8023f868.html,,oral,LD50,124 mg/kg bw,adverse effect observed, "5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid",36888-99-0,"Repeated dose toxicity: oral Read-across from CAS 76199-85-4: Key: oral, rat, 28 day study: NOEL (male/female) = 1000 mg/kg bw/day (GLP, OECD 407 with restrictions, 2000)   Repeated dose toxicity: inhalative Read-across from CAS 36888-99-0_nano: Key: inhalative, rat, 5 day study with 3 weeks recovery: NOAEC (local) = 5 mg/m3 air, NOAEC (systemic) = 60 mg/m3 air (GLP, similar to OECD 412, 2022) ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6b5c08d-9660-43a3-9ff0-dbee89342847/documents/43d51f88-d169-492b-9fa8-411b3777d514_ce1ef912-a19b-4010-a195-9998104530b7.html,,,,,, "5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid",36888-99-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6b5c08d-9660-43a3-9ff0-dbee89342847/documents/43d51f88-d169-492b-9fa8-411b3777d514_ce1ef912-a19b-4010-a195-9998104530b7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid",36888-99-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6b5c08d-9660-43a3-9ff0-dbee89342847/documents/43d51f88-d169-492b-9fa8-411b3777d514_ce1ef912-a19b-4010-a195-9998104530b7.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,60 mg/m3,,rat "5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid",36888-99-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6b5c08d-9660-43a3-9ff0-dbee89342847/documents/43d51f88-d169-492b-9fa8-411b3777d514_ce1ef912-a19b-4010-a195-9998104530b7.html,Repeated dose toxicity – local effects,inhalation,NOAEC,5 mg/m3,adverse effect observed,rat "5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid",36888-99-0,"Key: oral, rat: LD50 > 10000 mg/kg bw; transient signs of toxicity: yellow dyed feces (non-GLP, similar to OECD 401, 1973) Read-across from CAS 76199-85-4: Key: inhalative, rat: LC50 >5.42 mg dust/L air; signs of toxicity: no mortality and no toxicity observed (non-GLP, similar to OECD 403, 1982)   Sup: inhalative, rat: no mortality in a dust-enriched atmosphere; signs of toxicity: no abnormalities detected (non-GLP, non-guideline, 1973) Key: dermal, rat: LD50 > 2500 mg/kg bw; transient signs of toxicity: no abnormality detected (non-GLP, similar to OECD 402, 1973) Sup: intraperitoneal, mouse: LD50 > 6400 mg/kg bw; signs of toxicity: no mortality; accelerated respiration, spastic gait and stretching, hunched body posture, closed eyes (non-GLP, non-guideline, 1973) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6b5c08d-9660-43a3-9ff0-dbee89342847/documents/42964555-c568-4347-8a17-d7338dfd6e40_ce1ef912-a19b-4010-a195-9998104530b7.html,,,,,, "5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid",36888-99-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6b5c08d-9660-43a3-9ff0-dbee89342847/documents/42964555-c568-4347-8a17-d7338dfd6e40_ce1ef912-a19b-4010-a195-9998104530b7.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid",36888-99-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6b5c08d-9660-43a3-9ff0-dbee89342847/documents/42964555-c568-4347-8a17-d7338dfd6e40_ce1ef912-a19b-4010-a195-9998104530b7.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "5,5'-(1H-isoindole-1,3(2H)-diylidene)dibarbituric acid",36888-99-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6b5c08d-9660-43a3-9ff0-dbee89342847/documents/42964555-c568-4347-8a17-d7338dfd6e40_ce1ef912-a19b-4010-a195-9998104530b7.html,,inhalation,discriminating conc.,"5,420 mg/m3",no adverse effect observed, "5',5'''-[ethylenebis(p-phenyleneazo)]bis[1',2'-dihydro-6'-hydroxy-4'-methyl-2'-oxo-1,3'-bipyridinium] dilactate",71032-99-0," NOAEL (sub-acute, male, rat) = 83 mg/kg bw/day NOAEL (sub-acute, female, rat) < 83 mg/kg bw/day; LOAEL = 83 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/28f71a66-c234-43ef-be30-5a3b1b9ff1ee/documents/529aa3ac-7f70-42e1-899f-74611f613d01_ec92cf2d-b4f7-4b25-9452-c751ac63d934.html,,,,,, "5',5'''-[ethylenebis(p-phenyleneazo)]bis[1',2'-dihydro-6'-hydroxy-4'-methyl-2'-oxo-1,3'-bipyridinium] dilactate",71032-99-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/28f71a66-c234-43ef-be30-5a3b1b9ff1ee/documents/529aa3ac-7f70-42e1-899f-74611f613d01_ec92cf2d-b4f7-4b25-9452-c751ac63d934.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,83 mg/kg bw/day,,rat "5',5'''-[ethylenebis(p-phenyleneazo)]bis[1',2'-dihydro-6'-hydroxy-4'-methyl-2'-oxo-1,3'-bipyridinium] dilactate",71032-99-0, Oral LD50 (male and female) > 5000 mg/kg bw ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28f71a66-c234-43ef-be30-5a3b1b9ff1ee/documents/ac2654ca-0603-40bf-ab43-d50b67e57103_ec92cf2d-b4f7-4b25-9452-c751ac63d934.html,,,,,, "5',5'''-[ethylenebis(p-phenyleneazo)]bis[1',2'-dihydro-6'-hydroxy-4'-methyl-2'-oxo-1,3'-bipyridinium] dilactate",71032-99-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28f71a66-c234-43ef-be30-5a3b1b9ff1ee/documents/ac2654ca-0603-40bf-ab43-d50b67e57103_ec92cf2d-b4f7-4b25-9452-c751ac63d934.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "5,5'-dithiodi-1,3,4-thiadiazole-2(3H)-thione",72676-55-2,"Several relevant repeated-dose toxicity studies conducted via the oral route are available on the registered substance.   During an OECD 422, it was concluded that the NOAEL was 100 mg/kg/day based on:Reduction in bodyweight gain at 1000 mg/kg/day in males considered adverse.Microscopic changes observed for multiple organs at 300 and/or 1000 mg/kg/day (kidney, liver, thyroid) considered adverse, as it correlates with biochemical changes (lower alanine aminotransferase).   During an OECD 408, it was concluded that the NOAEL was 300 mg/kg/day based on:Reduction in bodyweight gain at 1000 mg/kg/day in males considered adverse.Higher thyroid gland weights, enlargement and increased incidences and severity of follicular cell hypertrophy/hyperplasia, including a possible related adenoma, and related changes in hormone levels (high TSH and low T3, T4).Combination of findings in the kidneys at 1000 mg/kg/day.Possible test material related diffuse hyperplasia in the urinary bladder and urethra of a single female.Reduction in alanine aminotransferase was not considered as adverse in the absence of clear histopathological correlation.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The key study is considered as reliable with a klimish score of 1. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bcd266b1-8eec-4e8f-a769-10777eecfbc6/documents/e957a3aa-46a4-48f6-9aff-2a0f0c3247c3_91d090e5-fa2c-48f9-8440-9db48e088792.html,,,,,, "5,5'-dithiodi-1,3,4-thiadiazole-2(3H)-thione",72676-55-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bcd266b1-8eec-4e8f-a769-10777eecfbc6/documents/e957a3aa-46a4-48f6-9aff-2a0f0c3247c3_91d090e5-fa2c-48f9-8440-9db48e088792.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "5,5'-dithiodi-1,3,4-thiadiazole-2(3H)-thione",72676-55-2,"The acute toxicity of 5,5'-Dithiodi-1,3,4-dithiazole-2(3H)-thione was evaluated by oral and dermal route in rats. LD50 are higher than 2000 mg/kg bw in the oral and dermal acute studies. No study by inhalation is available as it is not a relevant route of exposure. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The oral acute study is considered to be reliable (performed with OECD and GLP guidelines). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The dermal acute study is considered to be reliable (performed with OECD and GLP guidelines). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcd266b1-8eec-4e8f-a769-10777eecfbc6/documents/e5aecc91-1867-4a21-aa5b-d227022d3411_91d090e5-fa2c-48f9-8440-9db48e088792.html,,,,,, "5,5'-dithiodi-1,3,4-thiadiazole-2(3H)-thione",72676-55-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcd266b1-8eec-4e8f-a769-10777eecfbc6/documents/e5aecc91-1867-4a21-aa5b-d227022d3411_91d090e5-fa2c-48f9-8440-9db48e088792.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "5,5'-dithiodi-1,3,4-thiadiazole-2(3H)-thione",72676-55-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcd266b1-8eec-4e8f-a769-10777eecfbc6/documents/e5aecc91-1867-4a21-aa5b-d227022d3411_91d090e5-fa2c-48f9-8440-9db48e088792.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "4,4‘ –Sulfonyldiphthalic acid dianhydride",2540-99-0,Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 423; GLP compliant) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcc98bb1-e9b9-4459-b925-8f9580bd39ce/documents/IUC5-7be57dff-6ae2-4abd-9076-cbd25e188a20_2447ce4c-a1b8-4fb6-8e70-2ee1f8ba4331.html,,,,,, "4,4‘ –Sulfonyldiphthalic acid dianhydride",2540-99-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcc98bb1-e9b9-4459-b925-8f9580bd39ce/documents/IUC5-7be57dff-6ae2-4abd-9076-cbd25e188a20_2447ce4c-a1b8-4fb6-8e70-2ee1f8ba4331.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "5,6,7,8-tetrahydroquinoline",10500-57-9," ACD/Percepta model for acute oral toxicity on rat provides LD50predictions for rats by oral administration route, based on the GALAS methodology. Prediction results are illustrated in Table 3.1 and discussed below. ACD/Percepta prediction Reliability Index (RI) Reliability assessment LD50(rat) = 1300 mg/kg 0.58 Moderate Reliable   The target compound is included in the applicability domain of the model since RI is equal to 0.58. The identified analogues of 5,6,7,8-tetrahydroquinoline exhibit moderate similarity with respect to 5,6,7,8-tetrahydroquinoline (similarity index ranging from 0.70 to 0.82), meaning that the target is moderately represented in the training set of the model. Experimental LD50 values for the traing set analogues are in the range 330 – 6700 mg/kg.   For the target, a reliability index equal to 0.58 was calculated, corresponding to a moderate reliable prediction. In fact, a limited uncertainty was associated to the LD50prediction, due to the following main issue: experimental data of structural analogues: wide range of LD50values (330 – 6700 mg/kg). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68b3017a-6366-4cc0-96ef-a7014396a55d/documents/ab1e1b3e-5e17-4c75-b06b-6f1659217251_0c0f6b94-71b7-441e-bea5-4f8a011b5217.html,,,,,, "5,6,7,8-tetrahydroquinoline",10500-57-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68b3017a-6366-4cc0-96ef-a7014396a55d/documents/ab1e1b3e-5e17-4c75-b06b-6f1659217251_0c0f6b94-71b7-441e-bea5-4f8a011b5217.html,,oral,LD50,"1,300 mg/kg bw",, Quinoxyfen,124495-18-7," 90-Day mouse feeding study LOAEL: 500 mg/kg bw/day for males and females; OECD 408; Reliability = 1 90-Day rat feeding study LOAEL: 100 mg/kg/day; OECD 408; Reliability = 1 90-Day dog feeding study LOAEL: >100 mg/kg/day (highest concentration tested); OECD 409; Reliability = 1 12-Month Neurotox Study Rat Diet Systemic LOAEL: 80 mg/kg, Neurotox LOEL: >80 mg/kg (highest dose tested); not neurotoxic. EPA 83-1; Reliability = 1 28-Day rat feeding study LOAEL: 250 mg/kg (lowest dose tested); FIFRA 82-1; Reliability = 2 28-day dog feeding study LOAEL = 250 mg/kg/day; FIFRA 82-1; Reliability = 2 28-Day Immunotox Study Rat Diet LOAEL: 100 mg/kg/day; no humoral immune response. EPA OPPTS 870.7800; Reliability = 1 28-day rat dermal study LOAEL > 1000 mg/kg/day; OECD 410; Reliability = 1 ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5fc2d94d-98ff-4c3b-ba44-717bd5501c68/documents/a9e3f459-0541-499b-8b34-595ea153cd64_6758290b-f7e7-4c05-bd13-e86417ba6232.html,,,,,, Quinoxyfen,124495-18-7,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5fc2d94d-98ff-4c3b-ba44-717bd5501c68/documents/a9e3f459-0541-499b-8b34-595ea153cd64_6758290b-f7e7-4c05-bd13-e86417ba6232.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat Quinoxyfen,124495-18-7,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5fc2d94d-98ff-4c3b-ba44-717bd5501c68/documents/a9e3f459-0541-499b-8b34-595ea153cd64_6758290b-f7e7-4c05-bd13-e86417ba6232.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat Quinoxyfen,124495-18-7,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5fc2d94d-98ff-4c3b-ba44-717bd5501c68/documents/a9e3f459-0541-499b-8b34-595ea153cd64_6758290b-f7e7-4c05-bd13-e86417ba6232.html,Repeated dose toxicity – local effects,dermal,NOAEL,"1,000 mg/cm2",no adverse effect observed,rat Quinoxyfen,124495-18-7, Oral: rat LD50: >5000 mg/kg. OECD 401; Reliability = 1 Dermal: rabbit LD50: >2000 mg/kg. OECD 402; Reliability = 1 Inhalation: rat 4-hour LC50: >3.38 mg/L (maximum achievable concentration); OECD 403; Reliability = 1 ,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fc2d94d-98ff-4c3b-ba44-717bd5501c68/documents/6bf1da95-ecc6-406e-a0b6-9cbee71a7abe_6758290b-f7e7-4c05-bd13-e86417ba6232.html,,,,,, Quinoxyfen,124495-18-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fc2d94d-98ff-4c3b-ba44-717bd5501c68/documents/6bf1da95-ecc6-406e-a0b6-9cbee71a7abe_6758290b-f7e7-4c05-bd13-e86417ba6232.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Quinoxyfen,124495-18-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fc2d94d-98ff-4c3b-ba44-717bd5501c68/documents/6bf1da95-ecc6-406e-a0b6-9cbee71a7abe_6758290b-f7e7-4c05-bd13-e86417ba6232.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Quinoxyfen,124495-18-7,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fc2d94d-98ff-4c3b-ba44-717bd5501c68/documents/6bf1da95-ecc6-406e-a0b6-9cbee71a7abe_6758290b-f7e7-4c05-bd13-e86417ba6232.html,,inhalation,LC50,3.38 mg/m3,no adverse effect observed, "5,7-Di-t-butyl-3-[3,5-dimethyl-4-[(1,3,7,9-tetra-t-butyl-5-methyl-5H-benzo[d][1,3,2]benzodioxaphosphocin-11-yl)oxy]phenyl]-3H-benzofuran-2-one",1803088-15-4," In a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test with rats, no adverse findings were reported and a NOAEL of 1000 mg/kg body weight was established. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9742543c-6ee4-4a0b-9b24-7e210a063547/documents/cba11593-bd39-4968-8597-3f458a732eae_dd128a7d-205a-4fb3-9aad-fd9999936c8f.html,,,,,, "5,7-Di-t-butyl-3-[3,5-dimethyl-4-[(1,3,7,9-tetra-t-butyl-5-methyl-5H-benzo[d][1,3,2]benzodioxaphosphocin-11-yl)oxy]phenyl]-3H-benzofuran-2-one",1803088-15-4,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9742543c-6ee4-4a0b-9b24-7e210a063547/documents/cba11593-bd39-4968-8597-3f458a732eae_dd128a7d-205a-4fb3-9aad-fd9999936c8f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "5,7-Di-t-butyl-3-[3,5-dimethyl-4-[(1,3,7,9-tetra-t-butyl-5-methyl-5H-benzo[d][1,3,2]benzodioxaphosphocin-11-yl)oxy]phenyl]-3H-benzofuran-2-one",1803088-15-4, The LD50 of the test item after oral administration was found to be greater than 2000 mg/kg bw in rats. The LD50 of the test item after dermal application was also found to be greater than 2000 mg/kg bw in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9742543c-6ee4-4a0b-9b24-7e210a063547/documents/3ca19002-8455-4ce4-860b-f7e3f6772032_dd128a7d-205a-4fb3-9aad-fd9999936c8f.html,,,,,, "5,7-Di-t-butyl-3-[3,5-dimethyl-4-[(1,3,7,9-tetra-t-butyl-5-methyl-5H-benzo[d][1,3,2]benzodioxaphosphocin-11-yl)oxy]phenyl]-3H-benzofuran-2-one",1803088-15-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9742543c-6ee4-4a0b-9b24-7e210a063547/documents/3ca19002-8455-4ce4-860b-f7e3f6772032_dd128a7d-205a-4fb3-9aad-fd9999936c8f.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "5,7-Di-t-butyl-3-[3,5-dimethyl-4-[(1,3,7,9-tetra-t-butyl-5-methyl-5H-benzo[d][1,3,2]benzodioxaphosphocin-11-yl)oxy]phenyl]-3H-benzofuran-2-one",1803088-15-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9742543c-6ee4-4a0b-9b24-7e210a063547/documents/3ca19002-8455-4ce4-860b-f7e3f6772032_dd128a7d-205a-4fb3-9aad-fd9999936c8f.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "5,9-dimethyldec-4-enal",689-65-6," Oral: NOAEL (rat): Repeated dose 28-day oral study (oral gavage to rats; Arachis oil vehicle) with 14-day recovery period: 0 (control), 30, 300 and 1000 mg/kg/day generated a NOAEL (male/female) = 1000 mg/kg bw /day OECD TG 407, GLP. 2017 ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/90dadb64-6c43-4dfd-8d56-1171fdec73a0/documents/IUC5-a3030140-1484-4671-9246-ecf9b1c47925_b65daccd-5f59-4987-90e5-8e0abb669119.html,,,,,, "5,9-dimethyldec-4-enal",689-65-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/90dadb64-6c43-4dfd-8d56-1171fdec73a0/documents/IUC5-a3030140-1484-4671-9246-ecf9b1c47925_b65daccd-5f59-4987-90e5-8e0abb669119.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "5,9-dimethyldec-4-enal",689-65-6," Oral: LD50 > 300 - < 2000 mg/kg bw, female rat, OECD TG 420, 2016 Inhalation: LC50 (female): 3.00 (C.I. 1.50 – 4.50) mg/L, OECD TG 403, 2016 Dermal: measured LD50 > 2000 mg/kg bw and the estimated LD50 cut-off value was considered to be > 5000 mg/kg bw, male/female rat, OECD TG 402, 2016 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90dadb64-6c43-4dfd-8d56-1171fdec73a0/documents/IUC5-ea7362b8-55d4-446d-b031-a1baea505dec_b65daccd-5f59-4987-90e5-8e0abb669119.html,,,,,, "5,9-dimethyldec-4-enal",689-65-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90dadb64-6c43-4dfd-8d56-1171fdec73a0/documents/IUC5-ea7362b8-55d4-446d-b031-a1baea505dec_b65daccd-5f59-4987-90e5-8e0abb669119.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, "5,9-dimethyldec-4-enal",689-65-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90dadb64-6c43-4dfd-8d56-1171fdec73a0/documents/IUC5-ea7362b8-55d4-446d-b031-a1baea505dec_b65daccd-5f59-4987-90e5-8e0abb669119.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "5,9-dimethyldec-4-enal",689-65-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90dadb64-6c43-4dfd-8d56-1171fdec73a0/documents/IUC5-ea7362b8-55d4-446d-b031-a1baea505dec_b65daccd-5f59-4987-90e5-8e0abb669119.html,,inhalation,LC50,"3,000 mg/m3",adverse effect observed, "5-[(2,3-dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]barbituric acid",72102-84-2, The NOAEL for the test substance was determined to be 1000 mg/kg bw in male and female animals after sub-acute repeated dose administration. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ca1b4eb-3a91-4174-ab01-444b9fa77871/documents/feb1daa5-adf9-476b-b9ef-b0e6f3582a86_ad29da70-a285-4a53-bbe2-32c9bdc45b92.html,,,,,, "5-[(2,3-dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]barbituric acid",72102-84-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ca1b4eb-3a91-4174-ab01-444b9fa77871/documents/feb1daa5-adf9-476b-b9ef-b0e6f3582a86_ad29da70-a285-4a53-bbe2-32c9bdc45b92.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "5-[(2,3-dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]barbituric acid",72102-84-2, The acute oral LD50 of the test material in rats is > 6000 mg/kg bw. The acute oral LD50 of the test material in hamsters is > 3000 mg/kg bw. The inhalation LC50 of the test material in rats is > 2119 mg/m³ air. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ca1b4eb-3a91-4174-ab01-444b9fa77871/documents/a7fbc008-92dd-46ac-9ab8-8b8085df367f_ad29da70-a285-4a53-bbe2-32c9bdc45b92.html,,,,,, "5-[(2,3-dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]barbituric acid",72102-84-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ca1b4eb-3a91-4174-ab01-444b9fa77871/documents/a7fbc008-92dd-46ac-9ab8-8b8085df367f_ad29da70-a285-4a53-bbe2-32c9bdc45b92.html,,oral,discriminating dose,"6,000 mg/kg bw",no adverse effect observed, "5-[(2,3-dihydro-6-methyl-2-oxo-1H-benzimidazol-5-yl)azo]barbituric acid",72102-84-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ca1b4eb-3a91-4174-ab01-444b9fa77871/documents/a7fbc008-92dd-46ac-9ab8-8b8085df367f_ad29da70-a285-4a53-bbe2-32c9bdc45b92.html,,inhalation,discriminating conc.,2 mg/m3,no adverse effect observed, "5-[(3,4-dichlorophenyl)azo]-1,2-dihydro-6-hydroxy-1,4-dimethyl-2-oxonicotinonitrile",83249-52-9," The test item has a LD50 (oral, gavage) of >5000 mg/kg bw in male/female rats. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c458d209-3e17-4219-a7c9-c6a9cd5f6d72/documents/8ed1c43d-304b-4073-aa2b-acb896fa62fc_85798ff7-0ac8-47cb-ae0a-d5bd9d3db6a2.html,,,,,, 5-[(4-carboxybutanoyl)peroxy]-5-oxopentanoic acid,10195-54-7, The LD50 value for acute oral toxicity of the test item in Wistar rats was established to be 1276 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1f747d3-fed7-43b1-8805-c237aa6a031b/documents/f42a76ef-e069-462a-8f3e-c1411d720d14_274bdc57-690b-4c63-8fa8-e052df0987bf.html,,,,,, 5-[(4-carboxybutanoyl)peroxy]-5-oxopentanoic acid,10195-54-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1f747d3-fed7-43b1-8805-c237aa6a031b/documents/f42a76ef-e069-462a-8f3e-c1411d720d14_274bdc57-690b-4c63-8fa8-e052df0987bf.html,,oral,LD50,"1,276 mg/kg bw",adverse effect observed, "5-[(4-chloro-2-nitrophenyl)azo]-1-ethyl-1,2-dihydro-6-hydroxy-4-methyl-2-oxonicotinonitrile",70528-90-4,The acute oral LD50 of FAT 36091/D in rats of both sexes observed over a period of 14 days is approximately 8000 mg/kg. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ce10f9f-e362-4b58-a820-2251c1aec763/documents/IUC5-4ddd1fcf-32fb-4099-a471-07b9799691c1_4630a301-e98d-4263-8746-4f5b0839bcd5.html,,,,,, "5-[(4-chloro-2-nitrophenyl)azo]-1-ethyl-1,2-dihydro-6-hydroxy-4-methyl-2-oxonicotinonitrile",70528-90-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ce10f9f-e362-4b58-a820-2251c1aec763/documents/IUC5-4ddd1fcf-32fb-4099-a471-07b9799691c1_4630a301-e98d-4263-8746-4f5b0839bcd5.html,,oral,LD50,"8,000 mg/kg bw",no adverse effect observed, "5-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonic acid, sodium salt",78952-61-1,No adverse effects observed after repeated admnistration ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f90c448d-ee90-4a98-a9f9-5c7988b1ecb8/documents/IUC5-1ecf8cce-7fe8-4c45-856e-71fea07c72b9_8839310e-33bf-450f-be7e-ffd4d8bef74c.html,,,,,, "5-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonic acid, sodium salt",78952-61-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f90c448d-ee90-4a98-a9f9-5c7988b1ecb8/documents/IUC5-1ecf8cce-7fe8-4c45-856e-71fea07c72b9_8839310e-33bf-450f-be7e-ffd4d8bef74c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "5-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonic acid, sodium salt",78952-61-1,The test substance is practically non-toxic ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f90c448d-ee90-4a98-a9f9-5c7988b1ecb8/documents/IUC5-91e485fe-fce0-4654-8f67-df1858ce1101_8839310e-33bf-450f-be7e-ffd4d8bef74c.html,,,,,, "5-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonic acid, sodium salt",78952-61-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f90c448d-ee90-4a98-a9f9-5c7988b1ecb8/documents/IUC5-91e485fe-fce0-4654-8f67-df1858ce1101_8839310e-33bf-450f-be7e-ffd4d8bef74c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "5-[[4-chloro-6-[(3-sulphophenyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonic acid, sodium salt",78952-61-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f90c448d-ee90-4a98-a9f9-5c7988b1ecb8/documents/IUC5-91e485fe-fce0-4654-8f67-df1858ce1101_8839310e-33bf-450f-be7e-ffd4d8bef74c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride",29508-47-2," Repeated dose toxicity: Oral Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride. The study assumed the use of male and female Wistar rats. Since no significant treatment related effects were observed, hence the No Observed Adverse Effect Level (NOAEL) for 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride is predicted to be 260.350006104 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. Repeated dose toxicity: Inhalation 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride has very low  vapor pressure (2.31E-007 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated inhalation toxicity was considered for waiver Repeated dose toxicity: Dermal The acute dermal toxicity value for 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not irritating and not sensitizing to skin. Based on these considerations, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/99799fac-32cd-4b16-94d8-80f4c1cac98d/documents/5584d005-edaa-4738-9817-be18421e56c2_13b4bd90-a853-41e1-929b-cc5b7b2aa953.html,,,,,, "5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride",29508-47-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/99799fac-32cd-4b16-94d8-80f4c1cac98d/documents/5584d005-edaa-4738-9817-be18421e56c2_13b4bd90-a853-41e1-929b-cc5b7b2aa953.html,Chronic toxicity – systemic effects,oral,NOAEL,260.35 mg/kg bw/day,,rat "5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride",29508-47-2," Acute Oral Toxicity:  Acute oral toxicity dose was predicted based on OECD QSAR toolbox for target substance 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2)was estimated to be 4929.75 mg/kg bw on rats and for it’s closely related read across substance 1-Methylpiperazine (109-01-3) was considered to be 2830 mg/kg bw and for it’s functionally similar read across substance Tetrasodium 4-acetamido-5-hydroxy-6-({7-sulfonato-4-[(4-sulfonatophenyl)diazenyl]-1-naphthyl}diazenyl)naphthalene-1,7-disulfonate (2519-30-4) was considered to be >2000 mg/kg bw.All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) can be classified as category V of acute oral toxicity. Acute Inhalation Toxicity:  5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride has very low vapor pressure (2.31E-007 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated inhalation toxicity was considered for waiver. Acute Dermal Toxicity: Acute dermal toxicity dose was predicted based on OECD QSAR toolbox for target substance 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) was estimated to be 3767.01mg/kg bw and for different studies available on structurally similar read across substance2-[[4-(Dimethylamino)phenyl]azo]-1,3-dimethyl-1H-imidazolium chloride (77061-58-6) was considered to be >2000 mg/kg bw and 2-[(4-Aminophenyl)azo]-1,3-dimethyl-1H-imidazolium chloride (97404-02-9) was considered to be >2000 mg/kg bw.All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride (29508-47-2) can be classified as category V of acute dermal toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99799fac-32cd-4b16-94d8-80f4c1cac98d/documents/16dfdc2d-d9bd-44f7-abdd-062a77a0413b_13b4bd90-a853-41e1-929b-cc5b7b2aa953.html,,,,,, "5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride",29508-47-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99799fac-32cd-4b16-94d8-80f4c1cac98d/documents/16dfdc2d-d9bd-44f7-abdd-062a77a0413b_13b4bd90-a853-41e1-929b-cc5b7b2aa953.html,,oral,LD50,"4,929.75 mg/kg bw",no adverse effect observed, "5-[[p-(benzylmethylamino)phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium chloride",29508-47-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99799fac-32cd-4b16-94d8-80f4c1cac98d/documents/16dfdc2d-d9bd-44f7-abdd-062a77a0413b_13b4bd90-a853-41e1-929b-cc5b7b2aa953.html,,dermal,LD50,"3,767.01 mg/kg bw",no adverse effect observed, "5′-O-(4,4′-dimethoxytrityl)-2′-deoxythymidine-3′-O-[O-(2-cyanoethyl)-N,N′-diisopropylphosphoramidite]",98796-51-1," In an acute oral toxicity study in rats conducted according to OECD 423, one animal out of six died at the limit dose of 2000 mg/kg bw. Based on the results, the LD50 can be considered to be greater 2000 mg/kg bw and the LD50 cut-off value was determined to be 2500 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e04fb64-5e8c-4eda-bbca-a089ec35483f/documents/ad3fb385-991d-4821-9eec-73c6d8a846c0_6353578f-0f6f-4884-87c1-ad025f96c9ae.html,,,,,, 5-acetamido-2-aminobenzenesulphonic acid,96-78-6," Acute oral toxicity LD50 was estimated to be 2598.40mg/kg bw, when female Wistar rats were exposed with 2-amino-5-acetamidobenzene-1-sulfonic acid (96-78-6) orally. Acute dermal toxicity LD50 was estimated to be 3738.35mg/kg bw, when male and female Sprague-Dawley rats were exposed with 2-amino-5-acetamidobenzene-1-sulfonic acid (96-78-6) by dermal application. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43c1bf95-f05b-46d8-b76b-bf20f39e4ce1/documents/d593149a-94ee-4f23-8ab7-ce2248b44637_2327193f-c207-47e1-8c2b-0aa7686998d9.html,,,,,, 5-acetamido-2-aminobenzenesulphonic acid,96-78-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43c1bf95-f05b-46d8-b76b-bf20f39e4ce1/documents/d593149a-94ee-4f23-8ab7-ce2248b44637_2327193f-c207-47e1-8c2b-0aa7686998d9.html,,oral,LD50,"2,598.4 mg/kg bw",no adverse effect observed, 5-acetamido-2-aminobenzenesulphonic acid,96-78-6,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43c1bf95-f05b-46d8-b76b-bf20f39e4ce1/documents/d593149a-94ee-4f23-8ab7-ce2248b44637_2327193f-c207-47e1-8c2b-0aa7686998d9.html,,dermal,LD50,"3,738.35 mg/kg bw",no adverse effect observed, "5-acetyl-10,11-dihydro-3-nitro-5H-dibenz[b,f]azepine",79752-03-7, The Predicted Oral rat LD50 for the substance by Consensus method was 1609.60 mg/kg bw. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c77ebab4-9fe7-4a4b-95c1-a270e7f7628a/documents/2815b4b1-d3c3-4f6d-82ce-3d1a6ea540c3_9d8bc4a5-071f-4072-a7fa-44c07d92402a.html,,,,,, 5-acetylsalicylamide,40187-51-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d19be05-1dd4-4659-a5f6-5eb8f2e31236/documents/1b3eed9d-6bdb-4f3f-ba92-85a1d8e5437e_50c10db5-4b1d-401b-b8b4-e69c846f96ff.html,,oral,LD50,"1,700 mg/kg bw",adverse effect observed, "5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-(ethylsulfinyl)-1H-pyrazole-3-carbonitrile",181587-01-9," NOAEL (oral, rat, 28 d) = 9.2 (males) and 9.6 (females) mg/kg bw/day NOAEL (oral, rat, 90 d) = 1.2 (males) and 1.5 (females) mg/kg bw/day NOAEL (oral, rat, 52 weeks) = 0.98 (males) and 1.34 (females) mg/kg bw/day (chronic phase of the Combined Chronic Toxicity / Carcinogenicity study) NOAEL (dermal, rat, 28 d) = 10 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c33fa36-6cec-4785-9702-6a587e634e13/documents/IUC5-05d180fb-57d1-4d99-af11-9fe604731982_369230e7-cfac-4cee-bf73-2a65af8640e6.html,,,,,, "5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-(ethylsulfinyl)-1H-pyrazole-3-carbonitrile",181587-01-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c33fa36-6cec-4785-9702-6a587e634e13/documents/IUC5-05d180fb-57d1-4d99-af11-9fe604731982_369230e7-cfac-4cee-bf73-2a65af8640e6.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rat "5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-(ethylsulfinyl)-1H-pyrazole-3-carbonitrile",181587-01-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c33fa36-6cec-4785-9702-6a587e634e13/documents/IUC5-05d180fb-57d1-4d99-af11-9fe604731982_369230e7-cfac-4cee-bf73-2a65af8640e6.html,Chronic toxicity – systemic effects,oral,NOAEL,0.98 mg/kg bw/day,,rat "5-amino-1-[2,6-dichloro-4-(trifluoromethyl)phenyl]-4-(ethylsulfinyl)-1H-pyrazole-3-carbonitrile",181587-01-9,"Oral: OECD 423, rat (female), 2016: LD50 >2000 mg/kg bwDermal: OECD 402, rat (male/female), 2016: LD50 >2000 mg/kg bw (limit test) Inhalation (dust): OECD 403, rat (male/female), 4 h exposure, 2016: 1.22 mg/L < LC50 < 2.51 mg/L (1220 mg/m³ < LC50 < 2510 mg/m³) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c33fa36-6cec-4785-9702-6a587e634e13/documents/IUC5-d88a63d9-0957-4961-868a-1a6dd2fb8cbe_369230e7-cfac-4cee-bf73-2a65af8640e6.html,,,,,, "5-amino-2,4,6-triiodo-1,3-benzenedicarbonyldichloride",37441-29-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d3923f6-06a4-4b90-8260-1d24ce8001d8/documents/586e2c19-c1ea-49c2-813b-86e03568235e_982ddbe7-c0ac-46e7-888c-7233ac39eb0d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, "5-amino-2,4,6-triiodo-1,3-benzenedicarbonyldichloride",37441-29-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d3923f6-06a4-4b90-8260-1d24ce8001d8/documents/d1e4f5e4-d782-4c0a-ab89-ab02ff27ef42_982ddbe7-c0ac-46e7-888c-7233ac39eb0d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "5-amino-2,4,6-triiodo-1,3-benzenedicarbonyldichloride",37441-29-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d3923f6-06a4-4b90-8260-1d24ce8001d8/documents/d1e4f5e4-d782-4c0a-ab89-ab02ff27ef42_982ddbe7-c0ac-46e7-888c-7233ac39eb0d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "5-amino-2-chloro-N-(2,4-dimethylphenyl)benzenesulphonamide",71215-81-1, The LD50 of ACDMA in rat was found to be > 5000 mg/kg bw in test performed according to OECD TG 401 and GLP. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/646f46a4-b91c-4e6f-97ff-e13286272ba3/documents/b283537b-9c44-4d51-a10c-4faafdf8c3fc_74f99cd1-4193-4c8b-919a-fe306f0fc21e.html,,,,,, 5-amino-2-methoxybenzenesulphonic acid,6470-17-3," Acute oral toxicity:  Acute oral toxicity dose (LD50) of 5-amino-2-methoxybenzenesulphonic acid (CAS no: 6470-17-3) was predicted based on OECD QSAR toolbox 2374 mg/kg bw and different studies available on structurally similar read across substances 6-aminonaphthalene-2-sulphonic acid (CAS No. 93-00-5) 5000 mg/kg bw and 2,4-diaminobenzenesulfonic acid (CAS no: 88-63-1) 3480 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 5-amino-2-methoxybenzenesulphonic acid can be classified as category V of acute oral toxicity. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for 5-amino-2-methoxybenzenesulphonic acid (CAS no: 6470-17-3) was predicted based on OECD QSAR toolbox 3518 mg/kg bw and differentstudies available for the structurally similar read across substance 6-aminonaphthalene-2-sulphonic acid (CAS No. 93-00-5) >2000 mg/kg bw and functionally similar read across substance 4,4'-Diamino diphenyl sulfone (80-08-0) >4000 mg/kg bw. All these studies concluded that the LD50 value is>2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 5-amino-2-methoxybenzenesulphonic acid can be classified as category V of acute dermal toxicity. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7d38f3d-82c1-4243-bdde-0d37238d4dfa/documents/e7f41c80-41bb-43f1-a697-95680ab72f91_d7ff48c1-e300-41df-b464-3a40796f2c36.html,,,,,, 5-amino-2-methoxybenzenesulphonic acid,6470-17-3,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7d38f3d-82c1-4243-bdde-0d37238d4dfa/documents/e7f41c80-41bb-43f1-a697-95680ab72f91_d7ff48c1-e300-41df-b464-3a40796f2c36.html,,oral,LD50,"2,374 mg/kg bw",no adverse effect observed, 5-amino-2-methoxybenzenesulphonic acid,6470-17-3,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7d38f3d-82c1-4243-bdde-0d37238d4dfa/documents/e7f41c80-41bb-43f1-a697-95680ab72f91_d7ff48c1-e300-41df-b464-3a40796f2c36.html,,dermal,LD50,"3,518 mg/kg bw",no adverse effect observed, "5-amino-3-[[4-[[4-[[4-anilino-2-hydroxyphenyl]azo]phenyl]amino]-3-sulphophenyl]azo]-4-hydroxynaphthalene-2,7-disulphonic acid, sodium salt",85223-31-0," NOAEL (subacute) (rat, male and female): 350 mg/kg bw/day, systemic toxicity ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd133fee-40f5-4e26-b65c-6f61e72d38f2/documents/63dcc39e-d0f0-4bc8-9cdb-90750957ab4b_04f714c7-f371-48a5-81fe-e9b26e5a1272.html,,,,,, "5-amino-3-[[4-[[4-[[4-anilino-2-hydroxyphenyl]azo]phenyl]amino]-3-sulphophenyl]azo]-4-hydroxynaphthalene-2,7-disulphonic acid, sodium salt",85223-31-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd133fee-40f5-4e26-b65c-6f61e72d38f2/documents/63dcc39e-d0f0-4bc8-9cdb-90750957ab4b_04f714c7-f371-48a5-81fe-e9b26e5a1272.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,350 mg/kg bw/day,,rat "5-amino-3-[[4-[[4-[[4-anilino-2-hydroxyphenyl]azo]phenyl]amino]-3-sulphophenyl]azo]-4-hydroxynaphthalene-2,7-disulphonic acid, sodium salt",85223-31-0, Not harmful/toxic if swallowed Not harmful/toxic in contact with skin ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd133fee-40f5-4e26-b65c-6f61e72d38f2/documents/1a0c253d-3786-4810-8ae3-37aaa1ac51dc_04f714c7-f371-48a5-81fe-e9b26e5a1272.html,,,,,, "5-amino-3-[[4-[[4-[[4-anilino-2-hydroxyphenyl]azo]phenyl]amino]-3-sulphophenyl]azo]-4-hydroxynaphthalene-2,7-disulphonic acid, sodium salt",85223-31-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd133fee-40f5-4e26-b65c-6f61e72d38f2/documents/1a0c253d-3786-4810-8ae3-37aaa1ac51dc_04f714c7-f371-48a5-81fe-e9b26e5a1272.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "5-amino-3-[[4-[[4-[[4-anilino-2-hydroxyphenyl]azo]phenyl]amino]-3-sulphophenyl]azo]-4-hydroxynaphthalene-2,7-disulphonic acid, sodium salt",85223-31-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd133fee-40f5-4e26-b65c-6f61e72d38f2/documents/1a0c253d-3786-4810-8ae3-37aaa1ac51dc_04f714c7-f371-48a5-81fe-e9b26e5a1272.html,,dermal,LD50,"2,000 ",no adverse effect observed, "5-amino-6-methyl-1,3-dihydrobenzoimidazol-2-one",67014-36-2,Based on the results of a 4-week repeated dose oral toxicity study in rats the No Observed Adverse Effect Level (NOAEL) was determined to be 75 mg/kg bw/d. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdcdb457-d2b3-4301-a3a6-569824f332da/documents/IUC5-695b7e99-3d4b-4fb7-8f87-d9471c128932_0389d169-e2b6-43f9-a3a9-a4790e906ace.html,,,,,, "5-amino-6-methyl-1,3-dihydrobenzoimidazol-2-one",67014-36-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdcdb457-d2b3-4301-a3a6-569824f332da/documents/IUC5-695b7e99-3d4b-4fb7-8f87-d9471c128932_0389d169-e2b6-43f9-a3a9-a4790e906ace.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat "5-amino-6-methyl-1,3-dihydrobenzoimidazol-2-one",67014-36-2,The acute oral LD50 for the test substance is above 200 (0/3 animals died) and lower than or equal as 2000 mg/kg bw (all animals died) for both male and female rats. The dermal LD50 value exceeds 2000 mg/kg bw for male and female rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdcdb457-d2b3-4301-a3a6-569824f332da/documents/IUC5-c36eb649-c981-4a5f-b56d-f2ba3a293170_0389d169-e2b6-43f9-a3a9-a4790e906ace.html,,,,,, "5-amino-6-methyl-1,3-dihydrobenzoimidazol-2-one",67014-36-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdcdb457-d2b3-4301-a3a6-569824f332da/documents/IUC5-c36eb649-c981-4a5f-b56d-f2ba3a293170_0389d169-e2b6-43f9-a3a9-a4790e906ace.html,,oral,discriminating dose,200 mg/kg bw,adverse effect observed, "5-amino-6-methyl-1,3-dihydrobenzoimidazol-2-one",67014-36-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdcdb457-d2b3-4301-a3a6-569824f332da/documents/IUC5-c36eb649-c981-4a5f-b56d-f2ba3a293170_0389d169-e2b6-43f9-a3a9-a4790e906ace.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "5-benzoyl-7-bromo-2,3-dihydro-1H-Pyrrolizine-1-carboxylic acid",84023-60-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Data from the Supplier's Safety Data Sheet. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31612079-49d6-47b8-a7db-4186f6152702/documents/IUC5-0b28a3c8-bf3f-408b-89c3-e3dcb541e613_f8e23ea9-5e9f-478e-a874-a41151d4e450.html,,,,,, "5-benzoyl-7-bromo-2,3-dihydro-1H-Pyrrolizine-1-carboxylic acid",84023-60-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31612079-49d6-47b8-a7db-4186f6152702/documents/IUC5-0b28a3c8-bf3f-408b-89c3-e3dcb541e613_f8e23ea9-5e9f-478e-a874-a41151d4e450.html,,oral,LD50,189 mg/kg bw,, "Benzene, 5-[(4-bromo-2,6-difluorophenyl)difluoromethoxy]-1,2,3-trifluoro-",511540-64-0," Repeated dose toxicity (OECD 407, RL1): rat (m/f): NOAEL = 300 mg/kg bw/d (highest dose tested). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0c1efc6-71f0-42ae-abcb-bbec3059f6da/documents/ff3b522a-de61-484e-9215-e2c7ac2ded08_669f34b6-8dff-4581-8bb3-b34afa2ca0d5.html,,,,,, "Benzene, 5-[(4-bromo-2,6-difluorophenyl)difluoromethoxy]-1,2,3-trifluoro-",511540-64-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0c1efc6-71f0-42ae-abcb-bbec3059f6da/documents/ff3b522a-de61-484e-9215-e2c7ac2ded08_669f34b6-8dff-4581-8bb3-b34afa2ca0d5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Benzene, 5-[(4-bromo-2,6-difluorophenyl)difluoromethoxy]-1,2,3-trifluoro-",511540-64-0,"acute toxicity, oral (OECD 423, RL1), rats (m/f): LD50 > 2000 mg/kg bw acute toxicity, dermal (OECD 402, RL1), rats (f): LD50 > 2000 mg/kg bw Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): OECD Guideline study under GLP conditions Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): OECD Guideline study under GLP conditions ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0c1efc6-71f0-42ae-abcb-bbec3059f6da/documents/809b744b-6015-4d1a-9325-8cc872e4277a_669f34b6-8dff-4581-8bb3-b34afa2ca0d5.html,,,,,, "Benzene, 5-[(4-bromo-2,6-difluorophenyl)difluoromethoxy]-1,2,3-trifluoro-",511540-64-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0c1efc6-71f0-42ae-abcb-bbec3059f6da/documents/809b744b-6015-4d1a-9325-8cc872e4277a_669f34b6-8dff-4581-8bb3-b34afa2ca0d5.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Benzene, 5-[(4-bromo-2,6-difluorophenyl)difluoromethoxy]-1,2,3-trifluoro-",511540-64-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0c1efc6-71f0-42ae-abcb-bbec3059f6da/documents/809b744b-6015-4d1a-9325-8cc872e4277a_669f34b6-8dff-4581-8bb3-b34afa2ca0d5.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "5-bromo-1,3-dichloro-2-fluorobenzene",17318-08-0,"LOAEL: 30 mg/kg bw/day (oral gavage, male/female rats, OECD TG 422), based on atrophy of ameloblasts in female rats and lower body weight gain and histopathological changes in the liver, thyroid gland and forestomach in male rats. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/026a2c4d-bb9b-42a4-bd75-34fabdb4d1b3/documents/b66854c2-9bb7-4d2a-a0a6-3ae28bfacadd_039ca9b6-d8a2-442d-9682-d6c0b041e413.html,,,,,, "5-bromo-1,3-dichloro-2-fluorobenzene",17318-08-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/026a2c4d-bb9b-42a4-bd75-34fabdb4d1b3/documents/b66854c2-9bb7-4d2a-a0a6-3ae28bfacadd_039ca9b6-d8a2-442d-9682-d6c0b041e413.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,30 mg/kg bw/day,,rat "5-bromo-1,3-dichloro-2-fluorobenzene",17318-08-0,"Oral LD50 (rat): 2000 mg/kg bw < LD50 < 5000 mg/kg bw (GLP, OECD TG 425) Dermal LD50 (rat) >5000 mg/kg bw (GLP, OECD TG 402) Inhalation LC50 (rat) >5.36 mg/L (GLP, OECD TG 403) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/026a2c4d-bb9b-42a4-bd75-34fabdb4d1b3/documents/c037e6c2-4540-4c8c-a0ce-a3a5cd548363_039ca9b6-d8a2-442d-9682-d6c0b041e413.html,,,,,, "5-bromo-1,3-dichloro-2-fluorobenzene",17318-08-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/026a2c4d-bb9b-42a4-bd75-34fabdb4d1b3/documents/c037e6c2-4540-4c8c-a0ce-a3a5cd548363_039ca9b6-d8a2-442d-9682-d6c0b041e413.html,,oral,LD50,"> 2,000 mg/kg bw",adverse effect observed, "5-bromo-1,3-dichloro-2-fluorobenzene",17318-08-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/026a2c4d-bb9b-42a4-bd75-34fabdb4d1b3/documents/c037e6c2-4540-4c8c-a0ce-a3a5cd548363_039ca9b6-d8a2-442d-9682-d6c0b041e413.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "5-bromo-1,3-dichloro-2-fluorobenzene",17318-08-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/026a2c4d-bb9b-42a4-bd75-34fabdb4d1b3/documents/c037e6c2-4540-4c8c-a0ce-a3a5cd548363_039ca9b6-d8a2-442d-9682-d6c0b041e413.html,,inhalation,LC50,> 5.36 mg/L,no adverse effect observed, "5-butoxy-2-[4-(4-butoxy-2-hydroxyphenyl)-6-(2,4-dibutoxyphenyl)-1,3,5-triazin-2-yl]phenol",208343-47-9," Oral administration of the test material (by gavage) to rats at doses of 0, 50, 200 and 1000 mg/kg bw/day, for 28 days (OECD 407, GLP) did not cause any effects. The highest dose applied, 1000 mg/kg bw/day, was determined to be the NOAEL and the NOEL. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/086d0c98-0100-4dc7-9ac1-526be76af849/documents/355c9e2c-3db8-4491-a874-6d9f41626d34_c6241972-8f0b-4fad-a653-b334363f2ebc.html,,,,,, "5-butoxy-2-[4-(4-butoxy-2-hydroxyphenyl)-6-(2,4-dibutoxyphenyl)-1,3,5-triazin-2-yl]phenol",208343-47-9,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/086d0c98-0100-4dc7-9ac1-526be76af849/documents/355c9e2c-3db8-4491-a874-6d9f41626d34_c6241972-8f0b-4fad-a653-b334363f2ebc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "5-butoxy-2-[4-(4-butoxy-2-hydroxyphenyl)-6-(2,4-dibutoxyphenyl)-1,3,5-triazin-2-yl]phenol",208343-47-9," The acute oral and dermal toxicity of the test item was determined in two tests accroding GLP and OECD guideline 401 and 402, respectively. All animals survived until the scheduled day of necrospy. Clinical signs, changes in behaviour or marcoscopic signs were not observed. LD50 for oral and dermal acute toxicity is considered to be  > 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/086d0c98-0100-4dc7-9ac1-526be76af849/documents/2a7aa466-f16a-4e70-954b-795493d86763_c6241972-8f0b-4fad-a653-b334363f2ebc.html,,,,,, "5-butoxy-2-[4-(4-butoxy-2-hydroxyphenyl)-6-(2,4-dibutoxyphenyl)-1,3,5-triazin-2-yl]phenol",208343-47-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/086d0c98-0100-4dc7-9ac1-526be76af849/documents/2a7aa466-f16a-4e70-954b-795493d86763_c6241972-8f0b-4fad-a653-b334363f2ebc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "5-butoxy-2-[4-(4-butoxy-2-hydroxyphenyl)-6-(2,4-dibutoxyphenyl)-1,3,5-triazin-2-yl]phenol",208343-47-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/086d0c98-0100-4dc7-9ac1-526be76af849/documents/2a7aa466-f16a-4e70-954b-795493d86763_c6241972-8f0b-4fad-a653-b334363f2ebc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "5-chloro-1,3-dihydro-1-(4-piperidinyl)-2H-benzimidazol-2-one",53786-28-0," Repeated dose toxicity - oral: In a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the test substance was administered daily to rats up to a dose level of 150 mg/kg body weight/day (OECD 422, Van Otterdijk, 2016). The NOAEL is established as 50 mg/kg body weight/day and the LOAEL as 150 mg/kg body weight/day. The substance is therefore classified as STOT RE 2, according to CLP Regulation. Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69cfeac2-85a9-4100-bfa3-8833dd0d1b1c/documents/d0b0f187-6f90-41d2-9552-bf24a9f09f21_3003437c-aa8f-4539-aa02-1ea2979a16df.html,,,,,, "5-chloro-1,3-dihydro-1-(4-piperidinyl)-2H-benzimidazol-2-one",53786-28-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69cfeac2-85a9-4100-bfa3-8833dd0d1b1c/documents/d0b0f187-6f90-41d2-9552-bf24a9f09f21_3003437c-aa8f-4539-aa02-1ea2979a16df.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "5-chloro-1,3-dihydro-1-(4-piperidinyl)-2H-benzimidazol-2-one",53786-28-0," Acute toxicity: Oral: In an acute oral toxicity study in female Crl:WI (Han) (SPF) rats, following the acute toxic class method in accordance with the OECD Guideline 423 and EU Method B.1 tris, the LD50 was established to be within the range of 300 - 2000 mg/kg. According to the OECD 423 guideline, the LD50 cut-off value was considered to be 500 mg/kg body weight (Latour, 2015). Acute toxicity: Inhalation: In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For T000990, a key study is available for the dermal route of exposure. Therefore, an acute inhalation toxicity study should not be performed. Acute toxicity: Dermal: In an acute dermal toxicity study in male and female Crl:WI (Han) (SPF) rats, following the standard acute method according to OECD Guideline 402 and EC method B.3, the LD50 was established to exceed 2000 mg/kg body weight (Latour, 2016). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69cfeac2-85a9-4100-bfa3-8833dd0d1b1c/documents/e456e64f-8474-4cc6-be60-16cc47b8953a_3003437c-aa8f-4539-aa02-1ea2979a16df.html,,,,,, "5-chloro-1,3-dihydro-1-(4-piperidinyl)-2H-benzimidazol-2-one",53786-28-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69cfeac2-85a9-4100-bfa3-8833dd0d1b1c/documents/e456e64f-8474-4cc6-be60-16cc47b8953a_3003437c-aa8f-4539-aa02-1ea2979a16df.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "5-chloro-1,3-dihydro-1-(4-piperidinyl)-2H-benzimidazol-2-one",53786-28-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69cfeac2-85a9-4100-bfa3-8833dd0d1b1c/documents/e456e64f-8474-4cc6-be60-16cc47b8953a_3003437c-aa8f-4539-aa02-1ea2979a16df.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 5'-chloro-2'-methoxyacetoacetanilide,52793-11-0,"The study was performed according to EG Guideline B.1. 84/449/EWG, OECD 401 and GLP.The LD50 to male and female rats of the test item was determined to be greather than 2000 mg/kg body weight. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0dc84283-4ea2-4ab9-b231-e5c97bd19d6d/documents/IUC5-b8d1636e-e68a-42ab-a526-db765e1542b8_c0f64417-8c6c-4513-b150-d57813c4c91a.html,,,,,, 5-chloro-N-cyclohexylpentanamide,15865-18-6," No data were found for CIL3 in the scientific literature. As a result of QSAR analysis, the substance was predicted to have an oral rat LD50 between 1800 to 2100 mg/kg bw. These data are deemed to be quite reliable since the substance is in the applicability domain of the model. In spite of this, the cut-off value, which determines the classification or the non-classification under CLP Regulation, falls into the range of predicted values. Overall, data are judged as inconclusive for the classification. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3183295a-7443-40b7-9eff-23aeb1768f42/documents/0620f3d3-72c7-4eef-b7a5-58ddb6f068dc_fbb311a4-45a5-4cdb-afaf-76a2ef5f8301.html,,,,,, 5-chlorovaleryl chloride,1575-61-7,"The acute oral LD50 (EC Guideline B1, GLP) was determined to be more than 500 mg/kg bw and less than or equal to 2000 mg/kg bw. In an acute inhalation toxicity study (OECD 403, GLP), the LC50 was determined to be more than 0.32 mg/L air. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45a0ada1-93d0-4a59-ad26-202c1a6f2f16/documents/IUC5-7f8b1ccd-b59d-45ff-baf2-0e06ff1cc6b4_0c07437e-d403-4653-8b99-cace147c4444.html,,,,,, "5-Diazo-2,4,6(1H, 3H, 5H)-pyrimidinetrione",31221-06-4,"Diazobarbitursäure was tested for acute oral toxicity in female Wistar rats according to OECD TG 423, resulting in a LD50 ranging between 2000 and 300 mg/kg bw. 2000 mg/kg bw caused clear clinical signs of toxicity and the death of 3/3 rats within 7 days whereas 300 mg/kg bw was tolerated without any pathological findings and the animals survived until the end of the observation time.  ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ec383d7-a43b-4460-99c7-722fdcd78546/documents/IUC5-f052d12d-d8ee-43a7-bb86-942103dca295_e5231b80-734d-455e-b3f9-529cacb14b86.html,,,,,, "5-Diazo-2,4,6(1H, 3H, 5H)-pyrimidinetrione",31221-06-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ec383d7-a43b-4460-99c7-722fdcd78546/documents/IUC5-f052d12d-d8ee-43a7-bb86-942103dca295_e5231b80-734d-455e-b3f9-529cacb14b86.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, "5-ethyl-1,3-dioxane-5-methanol",5187-23-5,"A 91 -day oral toxicity study in the rat is available for CTF. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A high quality (Guideline- and GLP-compliant) 91-day oral rat study is available for CTF. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7db913f9-566a-418b-8a1f-dd7715cb0f35/documents/842edaaf-cf90-4f46-9272-f2ec3b4f69ac_ccad5b52-5433-40bd-9974-362cc91cc57a.html,,,,,, "5-ethyl-1,3-dioxane-5-methanol",5187-23-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7db913f9-566a-418b-8a1f-dd7715cb0f35/documents/842edaaf-cf90-4f46-9272-f2ec3b4f69ac_ccad5b52-5433-40bd-9974-362cc91cc57a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "5-ethyl-1,3-dioxane-5-methanol",5187-23-5,"5 -ethyl-1,3 -dioxane-5 -methanol is of low acute oral toxicity: an acute oral LD50 > 2000 mg/kg bw is reported. No mortality or any effects were notied in an acute dermal toxicity study up to 2000 mg/kg. The acute dermal LD 0 >= 2000 mg/kg b.w. is reported based on this study. A waiver is proposed in accordance with Column 2 of Annex VIII of the REACH Regulation for acute inhalation toxicity on the basis that acute toxicity data are available for the oral route, and that inhalation is not predicted to be a significant route of exposure based on the physicochemical properties of the substance.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): A high quality modern GLP- and guideline-compliant study is available for this endpoint. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): A reliable GLP study according to OECD 402 guideline. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7db913f9-566a-418b-8a1f-dd7715cb0f35/documents/97240240-9df9-4ed3-8e71-de997c2ca157_ccad5b52-5433-40bd-9974-362cc91cc57a.html,,,,,, "5-ethyl-1,3-dioxane-5-methanol",5187-23-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7db913f9-566a-418b-8a1f-dd7715cb0f35/documents/97240240-9df9-4ed3-8e71-de997c2ca157_ccad5b52-5433-40bd-9974-362cc91cc57a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "5-ethyl-1,3-dioxane-5-methanol",5187-23-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7db913f9-566a-418b-8a1f-dd7715cb0f35/documents/97240240-9df9-4ed3-8e71-de997c2ca157_ccad5b52-5433-40bd-9974-362cc91cc57a.html,,dermal,LD0,">=2,000 mg/kg bw",no adverse effect observed, 5-ethyl-2-methylpyridine,104-90-5,"A sub-acute toxicity study was carried out according to OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents) and EU Method B.7. The test item was administered per gavage to groups of 6 rats, male and female at dose levels of 30, 95 and 300 mg/kg bw/day. The NOAEL was determined to be 30 mg/kg bw/day. The LOAEL was determined at 95 mg/kg bw/day with slight clinical effects and minimal renal lesions in the male rats. At 300 mg/kg bw/day moderate clinical and clinicopathological effects and moderate renal lesions in male rats were found. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6cc783c-8327-452f-9ac6-65af640b2f1e/documents/IUC5-74c0de87-3f60-4020-80a0-923b86520005_f6de9560-44cd-481f-bfba-d99e56c3ed3e.html,,,,,, 5-ethyl-2-methylpyridine,104-90-5,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6cc783c-8327-452f-9ac6-65af640b2f1e/documents/IUC5-74c0de87-3f60-4020-80a0-923b86520005_f6de9560-44cd-481f-bfba-d99e56c3ed3e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat 5-ethyl-2-methylpyridine,104-90-5,"Several acute toxicity studies were carried out, with key studies available for all relevant routes. In addition, two supporting studies assessed acute oral toxicity. In a study similar or equivalent to EU Method B.1 and OECD Guideline 401 (Acute toxicity oral) the LD50 oral was determined to be 710 mg/kg bw. In a study similar or equivalent to EU Method B.2 and OECD Guideline 403 (Acute Inhalation Toxicity) the LC50 inhalation was determined 2.67 mg/L. In a study similar or equivalent to EU Method B.3 and OECD Guideline 402 (Acute Dermal Toxicity) the LD50 dermal was determined 1000 mL/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6cc783c-8327-452f-9ac6-65af640b2f1e/documents/IUC5-d3b0d937-e9c1-43ad-b311-1a025b008bf3_f6de9560-44cd-481f-bfba-d99e56c3ed3e.html,,,,,, 5-ethyl-2-methylpyridine,104-90-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6cc783c-8327-452f-9ac6-65af640b2f1e/documents/IUC5-d3b0d937-e9c1-43ad-b311-1a025b008bf3_f6de9560-44cd-481f-bfba-d99e56c3ed3e.html,,oral,LD50,710 mg/kg bw,adverse effect observed, 5-ethyl-2-methylpyridine,104-90-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6cc783c-8327-452f-9ac6-65af640b2f1e/documents/IUC5-d3b0d937-e9c1-43ad-b311-1a025b008bf3_f6de9560-44cd-481f-bfba-d99e56c3ed3e.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, 5-ethyl-2-methylpyridine,104-90-5,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6cc783c-8327-452f-9ac6-65af640b2f1e/documents/IUC5-d3b0d937-e9c1-43ad-b311-1a025b008bf3_f6de9560-44cd-481f-bfba-d99e56c3ed3e.html,,inhalation,LC50,2.67 mg/m3,adverse effect observed, "5-ethylidene-8,9,10-trinorborn-2-ene",16219-75-3," Based on the 14-wk inhalation study, the NOAEL for repeated inhalation toxicity in the rat is 24.8 ppm (122 mg/m3).  These values are based on systemic effects other than thyroid and kidney that are not considered  relevant to humans (IARC, 1998).   ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cca87a5f-4a15-44f4-b73a-468b89a8fbcf/documents/IUC5-71827b0b-234f-4e76-b22e-774883c4bfbb_018f4513-f67f-4899-b636-40dcfb58a9ce.html,,,,,, "5-ethylidene-8,9,10-trinorborn-2-ene",16219-75-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cca87a5f-4a15-44f4-b73a-468b89a8fbcf/documents/IUC5-71827b0b-234f-4e76-b22e-774883c4bfbb_018f4513-f67f-4899-b636-40dcfb58a9ce.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "5-ethylidene-8,9,10-trinorborn-2-ene",16219-75-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cca87a5f-4a15-44f4-b73a-468b89a8fbcf/documents/IUC5-71827b0b-234f-4e76-b22e-774883c4bfbb_018f4513-f67f-4899-b636-40dcfb58a9ce.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,122 mg/m3,,rat "5-ethylidene-8,9,10-trinorborn-2-ene",16219-75-3," ENB has a relatively low degree of acute toxicity in several species via oral and dermal but has significant toxicity by the inhalation route of administration. Oral LD50: All rat.  male: 2276mg/kg, female: 5071mg/kg, sex not specified: 2.83, 3.08, 3.125ml/kg Inhalation LC50: Rat male: 6.23, 13.5mg/l, female: 11.25, 15.1mg/l.  Mouse: male 5.5 mg/l, female 3.7mg/l.  Rabbit male: 15.5mg/l.  Guinea pig male: 14.4mg/l Dermal, rabbit LD50: 5.66 ,>8, 9.17ml/kg ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cca87a5f-4a15-44f4-b73a-468b89a8fbcf/documents/IUC5-44f8b566-627e-475d-9b5c-a1d3aa6669c2_018f4513-f67f-4899-b636-40dcfb58a9ce.html,,,,,, "5-ethylidene-8,9,10-trinorborn-2-ene",16219-75-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cca87a5f-4a15-44f4-b73a-468b89a8fbcf/documents/IUC5-44f8b566-627e-475d-9b5c-a1d3aa6669c2_018f4513-f67f-4899-b636-40dcfb58a9ce.html,,oral,LD50,"2,200 mg/kg bw",, "5-ethylidene-8,9,10-trinorborn-2-ene",16219-75-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cca87a5f-4a15-44f4-b73a-468b89a8fbcf/documents/IUC5-44f8b566-627e-475d-9b5c-a1d3aa6669c2_018f4513-f67f-4899-b636-40dcfb58a9ce.html,,dermal,LD50,"5,000 mg/kg bw",, "5H-1,2-oxathiole 2,2-dioxide",21806-61-1," Short-term repeated dose toxicity Subacute NOAEL (male/female, rat): 45 mg/kg bw/day (OECD 422/GLP)   ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ae361ad-8bd4-4d9f-816b-7ab2c4bf4acc/documents/d44fae36-e430-494a-9d97-5a78b5fb9d01_b55b5fad-eb84-442b-a189-4081d12713f4.html,,,,,, "5H-1,2-oxathiole 2,2-dioxide",21806-61-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ae361ad-8bd4-4d9f-816b-7ab2c4bf4acc/documents/d44fae36-e430-494a-9d97-5a78b5fb9d01_b55b5fad-eb84-442b-a189-4081d12713f4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,45 mg/kg bw/day,,rat "5H-1,2-oxathiole 2,2-dioxide",21806-61-1, Acute oral toxicity: LD50 (female) = > 50 mg/kg - 300 mg/ kg bw (OECD 423/GLP). Acute inhalation toxicity: LC50 (male/female) = >2.08 mgL (OECD 403/GLP) ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae361ad-8bd4-4d9f-816b-7ab2c4bf4acc/documents/337608c1-a6b2-4b49-ac1e-26f5d17af07a_b55b5fad-eb84-442b-a189-4081d12713f4.html,,,,,, "5H-1,2-oxathiole 2,2-dioxide",21806-61-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae361ad-8bd4-4d9f-816b-7ab2c4bf4acc/documents/337608c1-a6b2-4b49-ac1e-26f5d17af07a_b55b5fad-eb84-442b-a189-4081d12713f4.html,,oral,LD50,50 mg/kg bw,adverse effect observed, "5H-1,2-oxathiole 2,2-dioxide",21806-61-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae361ad-8bd4-4d9f-816b-7ab2c4bf4acc/documents/337608c1-a6b2-4b49-ac1e-26f5d17af07a_b55b5fad-eb84-442b-a189-4081d12713f4.html,,inhalation,LC50,"2,080 mg/m3",no adverse effect observed, "7,7,8,9,9-pentamethyl-6,6a,7,8,9,9a-hexahydro-5H-cyclopenta[h]quinazoline",1392325-86-8,In the repeated dose toxicity study performed according to OECD TG 407 the following results were found: The local NOAEL was determined to be 300 ppm corresponding to 22.1 mg/kg bw/day based on irritation effects in the stomach. The systemic NOAEL was determined to be 300 ppm corresponding to 22.1 mg/kg bw/day based increased liver weight accompanied by changes in clinical chemistry parameters and histopathological abnormalities. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1399f8ea-b3fa-4260-b6fe-3791733c93a2/documents/IUC5-3ea1dcc7-2c85-4cac-8c9e-cf0f84fcc130_90958cd7-b5cd-4ebf-9cc2-09c02e8e8843.html,,,,,, "7,7,8,9,9-pentamethyl-6,6a,7,8,9,9a-hexahydro-5H-cyclopenta[h]quinazoline",1392325-86-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1399f8ea-b3fa-4260-b6fe-3791733c93a2/documents/IUC5-3ea1dcc7-2c85-4cac-8c9e-cf0f84fcc130_90958cd7-b5cd-4ebf-9cc2-09c02e8e8843.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,22.1 mg/kg bw/day,,rat "7,7,8,9,9-pentamethyl-6,6a,7,8,9,9a-hexahydro-5H-cyclopenta[h]quinazoline",1392325-86-8,Acute oral toxicity: LD50 is 300 -2000 mg/kg bw in an OECD TG 420 and roughly estimated to be 1850 mg/kg bw. Acute toxicity inhalation: LC50 is >5.11 mg/L air in an OECD TG 403. Acute dermal toxicity: LD50 is >2000 mg/kg bw in an OECD TG 402. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1399f8ea-b3fa-4260-b6fe-3791733c93a2/documents/IUC5-9c13f308-541f-4813-83ad-563533f37f60_90958cd7-b5cd-4ebf-9cc2-09c02e8e8843.html,,,,,, "7,7,8,9,9-pentamethyl-6,6a,7,8,9,9a-hexahydro-5H-cyclopenta[h]quinazoline",1392325-86-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1399f8ea-b3fa-4260-b6fe-3791733c93a2/documents/IUC5-9c13f308-541f-4813-83ad-563533f37f60_90958cd7-b5cd-4ebf-9cc2-09c02e8e8843.html,,oral,LD50,"1,850 mg/kg bw",adverse effect observed, "7,7,8,9,9-pentamethyl-6,7,8,9-tetrahydro-5H-cyclopenta[h]quinazoline",1315251-11-6,- The dietary repeated dose toxicity NOAEL is set to 9.1 mg/kg bw based on a Reproscreen study with additional repeated dose toxicity parameters (OECD TG 421) - The LOAEL is 43 mg/kg bw based on the dietary repeated dose toxicity study according to OECD TG 407 ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74f873bb-3fe0-4c70-94f2-87011537de8e/documents/IUC5-0ae03065-a64e-4d01-b7d1-1423773c1e92_1d6b10d6-8471-4491-8276-19041ac5b161.html,,,,,, "7,7,8,9,9-pentamethyl-6,7,8,9-tetrahydro-5H-cyclopenta[h]quinazoline",1315251-11-6,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74f873bb-3fe0-4c70-94f2-87011537de8e/documents/IUC5-0ae03065-a64e-4d01-b7d1-1423773c1e92_1d6b10d6-8471-4491-8276-19041ac5b161.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,9.1 mg/kg bw/day,,rat "7,7,8,9,9-pentamethyl-6,7,8,9-tetrahydro-5H-cyclopenta[h]quinazoline",1315251-11-6,- Acute oral toxicity: LD50 is 500 mg/kg bw in an OECD TG 423 - Acute inhalation toxicity: LC50 is >5.02 mg/L in an OECD TG 403 - Acute dermal toxicity: LD50 is >2000 mg/kg bw in an OECD TG 402 ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74f873bb-3fe0-4c70-94f2-87011537de8e/documents/IUC5-58c04edc-d1b9-4434-a0ce-f63c20dc954b_1d6b10d6-8471-4491-8276-19041ac5b161.html,,,,,, "7,7,8,9,9-pentamethyl-6,7,8,9-tetrahydro-5H-cyclopenta[h]quinazoline",1315251-11-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74f873bb-3fe0-4c70-94f2-87011537de8e/documents/IUC5-58c04edc-d1b9-4434-a0ce-f63c20dc954b_1d6b10d6-8471-4491-8276-19041ac5b161.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "7,7,8,9,9-pentamethyl-6,7,8,9-tetrahydro-5H-cyclopenta[h]quinazoline",1315251-11-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74f873bb-3fe0-4c70-94f2-87011537de8e/documents/IUC5-58c04edc-d1b9-4434-a0ce-f63c20dc954b_1d6b10d6-8471-4491-8276-19041ac5b161.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "7,7,8,9,9-pentamethyl-6,7,8,9-tetrahydro-5H-cyclopenta[h]quinazoline",1315251-11-6,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74f873bb-3fe0-4c70-94f2-87011537de8e/documents/IUC5-58c04edc-d1b9-4434-a0ce-f63c20dc954b_1d6b10d6-8471-4491-8276-19041ac5b161.html,,inhalation,LC50,> 5.02 mg/L,no adverse effect observed, "21a-Homo-6 alpha,7 alpha,15 alpha,16 alpha-tetrahydro-bis-3' H-cyclopropa[1',2':6,7;1'',2'':15,16]-5 beta,17 alpha-pregn-20-yne-3 beta,5,17,21a-tetrol",82543-17-7,"Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg [Nihon Schering K.K., Report No. A06868, 2004-03-19] Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg [Nihon Schering K.K., Report No. A06722, 2004-03-19] Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1bf2e20-6105-46cc-851a-180a16a7ea9d/documents/IUC5-fb279bb1-6d4e-44ce-bd96-2dc4efe5f0fb_52d30fd4-93a7-46df-bae2-bcd67472d8be.html,,,,,, "21a-Homo-6 alpha,7 alpha,15 alpha,16 alpha-tetrahydro-bis-3' H-cyclopropa[1',2':6,7;1'',2'':15,16]-5 beta,17 alpha-pregn-20-yne-3 beta,5,17,21a-tetrol",82543-17-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1bf2e20-6105-46cc-851a-180a16a7ea9d/documents/IUC5-fb279bb1-6d4e-44ce-bd96-2dc4efe5f0fb_52d30fd4-93a7-46df-bae2-bcd67472d8be.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "21a-Homo-6 alpha,7 alpha,15 alpha,16 alpha-tetrahydro-bis-3' H-cyclopropa[1',2':6,7;1'',2'':15,16]-5 beta,17 alpha-pregn-20-yne-3 beta,5,17,21a-tetrol",82543-17-7,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1bf2e20-6105-46cc-851a-180a16a7ea9d/documents/IUC5-fb279bb1-6d4e-44ce-bd96-2dc4efe5f0fb_52d30fd4-93a7-46df-bae2-bcd67472d8be.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "17 alpha-(3-Hydroxypropyl)-6 beta,7 beta;15 beta,16 beta-dimethylene-5 beta-androstane-3 beta,5,17 beta-triol",82543-18-8,"Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg[Nihon Schering K.K., Report No. A06867, 2004-06-18]Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg[Nihon Schering K.K., Report No. A06723, 2004-06-18] ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60582804-9184-4648-9c46-eafb632beb75/documents/IUC5-c3be324d-a12b-4680-862d-d9bcbdd3829d_f108058b-317b-44b4-9d21-4f8d7040ab3c.html,,,,,, 5-hydroxyiminobarbituric acid,87-39-8," Acute oral toxicity (LD50) of the target substance 5-hydroxyiminobarbituric acid were predicted using two QSAR applications, the OECD toolbox and the Danish QSAR database. The OECD Toolbox predicted an oral LD50 value of 4570 mg/kg which do not meet the classification criteria. However, using the Danish QSAR database an LD50 value of 1300 mg/kg in rats (reliability index 0.34) and 1800 mg/kg in mice (reliability index 0.15) were obtained. Due to lack of consistency and low reliability, data are not considered sufficient for a classification decision. However, there are no immediate alerts for acute toxicity of violuric acid. See also QSAR summary attached in section 13.2 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f40f8c15-20b3-4920-8aa9-a6338e6cd495/documents/88312468-0ad0-4a73-b368-7f85b2ac4d35_56a10f93-1398-4c2d-aff7-3bf6e99b405b.html,,,,,, "5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, reaction products with 1,2-propanediol",63948-88-9,The LD50s for the oral and dermal routes are greater than 2000 mg/kg bw in rats. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ada8da5-6819-47d0-93b6-055aa8a2c0e0/documents/4d0eda28-b7d6-4ae3-bd6f-601fc1e08c74_cdf3f555-d2ef-4f9a-bae8-9eff7eecd847.html,,,,,, "5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, reaction products with 1,2-propanediol",63948-88-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ada8da5-6819-47d0-93b6-055aa8a2c0e0/documents/4d0eda28-b7d6-4ae3-bd6f-601fc1e08c74_cdf3f555-d2ef-4f9a-bae8-9eff7eecd847.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "5-Isobenzofurancarboxylic acid, 1,3-dihydro-1,3-dioxo-, reaction products with 1,2-propanediol",63948-88-9,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ada8da5-6819-47d0-93b6-055aa8a2c0e0/documents/4d0eda28-b7d6-4ae3-bd6f-601fc1e08c74_cdf3f555-d2ef-4f9a-bae8-9eff7eecd847.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,4-dichloro-N-(2-cyanophenyl)-1,2-thiazole-5-carboxamide",224049-04-1,"Oral toxicity: Subacute toxicity Repeated dose 28-day oral toxicity (OECD 407, rat, m/f): NOAEL systemic = 10000 ppm, corresponding to 949 mg/kg bw/day in males and 1041 mg/kg bw/day in females Repeated dose 28-day oral toxicity (OECD 407, mouse, m/f): NOAEL systemic = 1000 ppm, corresponding to 196 mg/kg bw/day in males and 223 mg/kg bw/day in females   Subchronic toxicity Repeated dose 90-day oral toxicity (OECD 408, rat, m/f): NOAEL systemic = 2500 ppm, corresponding to 148 mg/kg bw/day in males and 178 mg/kg bw/day in females Repeated dose 90-day oral toxicity (OECD 408, mouse, m/f): NOAEL systemic = 7000 ppm, corresponding to 1309.5 mg/kg bw/day in males and 2476.6 mg/kg bw/day in females Repeated dose 90-day oral toxicity (OECD 409, dog, m/f): NOAEL systemic = 2000 ppm, corresponding to 51.1 mg/kg bw/day in males and 54.4 mg/kg bw/day in females Repeated dose 1-year oral toxicity (OECD 452, dog, m/f): NOAEL systemic = 1000 ppm, corresponding to 27.2 mg/kg bw/day in males and 26.9 mg/kg bw/day in females   Chronic toxicity Chronic toxicity (OECD 452, rat, m), 1 year, NOAEL systemic = 600 ppm, corresponding to 27.9 mg/kg bw/day in males and 37.3 mg/kg bw/day in females     Dermal toxicity: Repeated dose dermal toxicity (OECD 410, rat, m/f): NOEL local and systemic = 1000 mg/kg bw/day   ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c52eff84-f230-4a2d-8dc8-308fa26a480a/documents/8415004b-b879-43fc-9acc-274aaeb9feea_0fdfeed5-433f-452a-a1ae-3a3eab79fc89.html,,,,,, "3,4-dichloro-N-(2-cyanophenyl)-1,2-thiazole-5-carboxamide",224049-04-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c52eff84-f230-4a2d-8dc8-308fa26a480a/documents/8415004b-b879-43fc-9acc-274aaeb9feea_0fdfeed5-433f-452a-a1ae-3a3eab79fc89.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,196 mg/kg bw/day,,mouse "3,4-dichloro-N-(2-cyanophenyl)-1,2-thiazole-5-carboxamide",224049-04-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c52eff84-f230-4a2d-8dc8-308fa26a480a/documents/8415004b-b879-43fc-9acc-274aaeb9feea_0fdfeed5-433f-452a-a1ae-3a3eab79fc89.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "3,4-dichloro-N-(2-cyanophenyl)-1,2-thiazole-5-carboxamide",224049-04-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c52eff84-f230-4a2d-8dc8-308fa26a480a/documents/8415004b-b879-43fc-9acc-274aaeb9feea_0fdfeed5-433f-452a-a1ae-3a3eab79fc89.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,26.9 mg/kg bw/day,,dog "3,4-dichloro-N-(2-cyanophenyl)-1,2-thiazole-5-carboxamide",224049-04-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c52eff84-f230-4a2d-8dc8-308fa26a480a/documents/8415004b-b879-43fc-9acc-274aaeb9feea_0fdfeed5-433f-452a-a1ae-3a3eab79fc89.html,Chronic toxicity – systemic effects,oral,NOAEL,27.9 mg/kg bw/day,,rat "3,4-dichloro-N-(2-cyanophenyl)-1,2-thiazole-5-carboxamide",224049-04-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c52eff84-f230-4a2d-8dc8-308fa26a480a/documents/8415004b-b879-43fc-9acc-274aaeb9feea_0fdfeed5-433f-452a-a1ae-3a3eab79fc89.html,Repeated dose toxicity – local effects,dermal,NOAEL,3.96 mg/cm2,no adverse effect observed,rat "3,4-dichloro-N-(2-cyanophenyl)-1,2-thiazole-5-carboxamide",224049-04-1,"oral: LD50 rat > 2000 mg/kg bw (limit test) dermal: LD50 rat > 2000 mg/kg bw (limit test, occlusive conditions) inhalation: LC50 rat > 5.0 mg/L (limit test, 4h exposure, aerosol, nominal value)   ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c52eff84-f230-4a2d-8dc8-308fa26a480a/documents/IUC5-c46bb338-5638-4360-9c31-91cfcd96ee52_0fdfeed5-433f-452a-a1ae-3a3eab79fc89.html,,,,,, "3,4-dichloro-N-(2-cyanophenyl)-1,2-thiazole-5-carboxamide",224049-04-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c52eff84-f230-4a2d-8dc8-308fa26a480a/documents/IUC5-c46bb338-5638-4360-9c31-91cfcd96ee52_0fdfeed5-433f-452a-a1ae-3a3eab79fc89.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,4-dichloro-N-(2-cyanophenyl)-1,2-thiazole-5-carboxamide",224049-04-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c52eff84-f230-4a2d-8dc8-308fa26a480a/documents/IUC5-c46bb338-5638-4360-9c31-91cfcd96ee52_0fdfeed5-433f-452a-a1ae-3a3eab79fc89.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,4-dichloro-N-(2-cyanophenyl)-1,2-thiazole-5-carboxamide",224049-04-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c52eff84-f230-4a2d-8dc8-308fa26a480a/documents/IUC5-c46bb338-5638-4360-9c31-91cfcd96ee52_0fdfeed5-433f-452a-a1ae-3a3eab79fc89.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, 5-methoxy-2-methylsulphanilic acid,6471-78-9,Low concern for repeated dose toxicity of 5-methoxy-2-methylsulphanilic acid based on read-across with similar substances. ,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98ed96df-168b-4b4e-b196-533c7fdf0776/documents/IUC5-1f0721b1-a58f-4be6-bbe4-caf457c1f12e_7ef4b317-41ff-4a74-a4d3-9d9c95407e9c.html,,,,,, 5-methoxy-2-methylsulphanilic acid,6471-78-9,Low concern for acute toxicity of 5-methoxy-2-methylsulphanilic acid based on read-across with similar substances. ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98ed96df-168b-4b4e-b196-533c7fdf0776/documents/IUC5-fde36773-ab8c-4ff5-a00d-65adeb868ea5_7ef4b317-41ff-4a74-a4d3-9d9c95407e9c.html,,,,,, 5-methyloxazolidin-2-one,1072-70-4,"LD50 (oral, rat): > 2000 mg/kg bw (BASF SE, 2015) ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6029f7aa-0397-48ea-9383-1c8c475a4872/documents/IUC5-0e53fe71-8233-4560-b6e9-44d46b1a0924_4a286a24-f5b1-4a2b-a42b-8975f94c1a4d.html,,,,,, 5-methyloxazolidin-2-one,1072-70-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6029f7aa-0397-48ea-9383-1c8c475a4872/documents/IUC5-0e53fe71-8233-4560-b6e9-44d46b1a0924_4a286a24-f5b1-4a2b-a42b-8975f94c1a4d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 5-methylhexan-2-one,110-12-3,"Oral - Oral, 90 d, rat  gavage per os at a maximum tolerated dose level of 2000 mg/kg bw/day five days a week, no exact NOAEL for systemic toxicity was determined: NOAEL < 2000 mg/kg bw/day    Inhalation - inhalative, 96 days - (similar similar to OECD Guideline 413), rats, concentrations up to 2000 ppm via whole body inhalation, a total of 69 exposures: Severity of effects observed at 1000 ppm was minimal to moderate and there was a clear NOEC at 200 ppm for repeated inhalation exposure in rats exposed for 13 weeks.   Dermal - no study available ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e3a91c0-abbc-4948-ba3e-61c15f4754ee/documents/IUC5-4aba1d8a-4380-470e-a494-ab239d8402db_8a9bff7f-17e2-4096-a653-a5b6f99c413d.html,,,,,, 5-methylhexan-2-one,110-12-3,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e3a91c0-abbc-4948-ba3e-61c15f4754ee/documents/IUC5-4aba1d8a-4380-470e-a494-ab239d8402db_8a9bff7f-17e2-4096-a653-a5b6f99c413d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,950 mg/m3,,rat 5-methylhexan-2-one,110-12-3,"- Acute toxicity oral: study conducted according to an internal Eastman Kodak Company laboratory method, rats, dose levels: 1000, 2000, 4000 and 8000 mg/kg bw. LD50 is 5657mg/kg bw(m/f); - Acute toxicity inhalation: study conducted according to an internal Eastman Kodak Company laboratory method, rats, 6-hour inhalation period, whole body inhalation, concentrations 800, 1600, 3200 or 6400 ppm (actual achieved concentrations were 802, 1603, 3207 and 5878 ppm), LC50 = > 3707 < 5875 ppm, based on mortality, the calculated LC50 (6-hr) was approximately 3813 ppm (17806 mg/m3).  - Acute toxicity dermal: study conducted according to an internal Eastman Kodak Company laboratory method, guiney pigs, LDlo > 10 mL/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e3a91c0-abbc-4948-ba3e-61c15f4754ee/documents/IUC5-bdb51232-aa30-4b41-aa24-74139b9068f1_8a9bff7f-17e2-4096-a653-a5b6f99c413d.html,,,,,, 5-methylhexan-2-one,110-12-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e3a91c0-abbc-4948-ba3e-61c15f4754ee/documents/IUC5-bdb51232-aa30-4b41-aa24-74139b9068f1_8a9bff7f-17e2-4096-a653-a5b6f99c413d.html,,oral,LD50,"5,657 mg/kg bw",no adverse effect observed, 5-methylhexan-2-one,110-12-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e3a91c0-abbc-4948-ba3e-61c15f4754ee/documents/IUC5-bdb51232-aa30-4b41-aa24-74139b9068f1_8a9bff7f-17e2-4096-a653-a5b6f99c413d.html,,dermal,LD50,"16,000 mg/kg bw",no adverse effect observed, 5-methylhexan-2-one,110-12-3,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e3a91c0-abbc-4948-ba3e-61c15f4754ee/documents/IUC5-bdb51232-aa30-4b41-aa24-74139b9068f1_8a9bff7f-17e2-4096-a653-a5b6f99c413d.html,,inhalation,LC50,"17,806 mg/m3",no adverse effect observed, "5-nitro-2,4,6-triaminopyrimidine",1006-23-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP and OECD guideline compliant study ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a56cc8e-623d-4a5d-a1dc-82148d37af91/documents/dd9337ea-9c1c-4a11-8891-dea126745af1_ba7bd395-cc43-4bdd-8e19-60b7fc1d9159.html,,,,,, "5-nitro-2,4,6-triaminopyrimidine",1006-23-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a56cc8e-623d-4a5d-a1dc-82148d37af91/documents/dd9337ea-9c1c-4a11-8891-dea126745af1_ba7bd395-cc43-4bdd-8e19-60b7fc1d9159.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 5-nitroisophthalic acid,618-88-2," The acute oral toxicity dose (LD50) was considered based on study conducted on rats for the test chemical. The LD50 value was >5000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1479d20a-f281-4780-a768-1e462aae7b6c/documents/e6345b84-fda5-4fbc-bd59-a5c8625b4a0f_6ed55874-8d7a-4f56-a42e-d2d1530b207c.html,,,,,, 5-nitroisophthalic acid,618-88-2,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1479d20a-f281-4780-a768-1e462aae7b6c/documents/e6345b84-fda5-4fbc-bd59-a5c8625b4a0f_6ed55874-8d7a-4f56-a42e-d2d1530b207c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 5-nitro-o-anisidine,99-59-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The data is K2 level as the data has been obtained from QSAR model considered reliable by OECD. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The data is K2 level as the data has been obtained from QSAR model considered reliable by OECD. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/071ca8e0-d86e-4d9d-88cc-313e439ee64e/documents/IUC5-e4cb549c-5686-4f2d-904b-ef2ac1101b7a_cd60fbc2-8ff8-49b3-8414-1077471d96e9.html,,,,,, 5-nitro-o-anisidine,99-59-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/071ca8e0-d86e-4d9d-88cc-313e439ee64e/documents/IUC5-e4cb549c-5686-4f2d-904b-ef2ac1101b7a_cd60fbc2-8ff8-49b3-8414-1077471d96e9.html,,oral,LD50,"2,315.143 mg/kg bw",no adverse effect observed, 5-nitro-o-anisidine,99-59-2,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/071ca8e0-d86e-4d9d-88cc-313e439ee64e/documents/IUC5-e4cb549c-5686-4f2d-904b-ef2ac1101b7a_cd60fbc2-8ff8-49b3-8414-1077471d96e9.html,,inhalation,LC50,218.23 mg/m3,no adverse effect observed, 5-nitrosalicylic acid,96-97-9,"The substance 5-nitrosalicylic acid  does not exhibit repeated dose toxicity by oral,inhalation and dermal route. ",2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad4b7e45-9bbd-4349-bedd-9fc93fb829c1/documents/IUC5-6b4fe0e1-a666-4268-a731-1dbdfb431eb8_8aa1486c-663b-4c6d-826a-adfed38a07f0.html,,,,,, 5-nitrosalicylic acid,96-97-9,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad4b7e45-9bbd-4349-bedd-9fc93fb829c1/documents/IUC5-6b4fe0e1-a666-4268-a731-1dbdfb431eb8_8aa1486c-663b-4c6d-826a-adfed38a07f0.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,766.666 mg/kg bw/day,,rabbit 5-nitrosalicylic acid,96-97-9,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad4b7e45-9bbd-4349-bedd-9fc93fb829c1/documents/IUC5-6b4fe0e1-a666-4268-a731-1dbdfb431eb8_8aa1486c-663b-4c6d-826a-adfed38a07f0.html,Sub-chronic toxicity – systemic effects,oral,,452.16 mg/kg bw/day,,rat 5-nitrosalicylic acid,96-97-9,,2025-01-27,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad4b7e45-9bbd-4349-bedd-9fc93fb829c1/documents/IUC5-6b4fe0e1-a666-4268-a731-1dbdfb431eb8_8aa1486c-663b-4c6d-826a-adfed38a07f0.html,Sub-chronic toxicity – systemic effects,inhalation,,19.56 mg/m3,,rat 5-nitrosalicylic acid,96-97-9,"The substance 5-nitrosalicylic acid does not showed toxicity effect by oral,dermal and inhalation route within the dose levels mentioned in the respective end points. ",2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad4b7e45-9bbd-4349-bedd-9fc93fb829c1/documents/IUC5-711e26a9-3b6e-4203-b50b-a85ff628dedf_8aa1486c-663b-4c6d-826a-adfed38a07f0.html,,,,,, 5-nitrosalicylic acid,96-97-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad4b7e45-9bbd-4349-bedd-9fc93fb829c1/documents/IUC5-711e26a9-3b6e-4203-b50b-a85ff628dedf_8aa1486c-663b-4c6d-826a-adfed38a07f0.html,,oral,LD50,"2,400 mg/kg bw",no adverse effect observed, 5-nitrosalicylic acid,96-97-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad4b7e45-9bbd-4349-bedd-9fc93fb829c1/documents/IUC5-711e26a9-3b6e-4203-b50b-a85ff628dedf_8aa1486c-663b-4c6d-826a-adfed38a07f0.html,,dermal,LD50,"9,862.85 mg/kg bw",no adverse effect observed, 5-nitrosalicylic acid,96-97-9,,2025-01-27,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad4b7e45-9bbd-4349-bedd-9fc93fb829c1/documents/IUC5-711e26a9-3b6e-4203-b50b-a85ff628dedf_8aa1486c-663b-4c6d-826a-adfed38a07f0.html,,inhalation,LC50,"1,255 mg/m3",no adverse effect observed, "5'-O-(p,p'-dimethoxytrityl)thymidine",40615-39-2," In an acute oral toxicity study in rats conducted according to OECD 423, the target substance 5’-O-(4,4’-Dimethoxytrityl)thymidine showed no mortality at the limit dose of 2000 mg/kg bw. Hence, the LD50 value was considered to exceed 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5da0b5fe-8e98-4ec5-9ea2-4dfb4120d4cd/documents/d59e1fde-d1e2-4279-ae4c-ece72c58a48c_ed7c3f0d-49b0-4124-ae70-234580883aca.html,,,,,, 5'-O-[bis(4-methoxyphenyl)benzyl]-2'-deoxy-N-(2-methyl-1-oxopropyl)guanosine,68892-41-1," In an acute oral toxicity study in rats conducted according to OECD 423, the target substance N2-Isobutyryl-5’-O-(4,4’-Dimethoxytrityl)-2’-deoxyguanosine showed no mortality at the limit dose of 2000 mg/kg bw. Hence, the LD50 value is considered to exceed 2000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50ebe46a-bdd5-4575-9e1f-3d379e62d1d5/documents/da9191d4-71a1-4387-8f0a-a2d793a6071a_e45ef63b-9f60-4486-9d6e-3bd72002c4f7.html,,,,,, 5-octylbicyclo[2.2.1]hept-2-ene,22094-84-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 1 ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7bfa6b2-d281-49b4-8a29-d8d6290b5c02/documents/394d060c-9d84-4947-a399-8ef04a273c64_2defc286-a84a-4a0a-ab8e-97e0c5bf7890.html,,,,,, 5-octylbicyclo[2.2.1]hept-2-ene,22094-84-4,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7bfa6b2-d281-49b4-8a29-d8d6290b5c02/documents/394d060c-9d84-4947-a399-8ef04a273c64_2defc286-a84a-4a0a-ab8e-97e0c5bf7890.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid,118-47-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): K2 predicted data ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0ad7051-f123-4559-acd9-e1fe71650ecc/documents/IUC5-c530cefa-2a13-4cf9-9952-a7666b8efa0e_5806a03b-ab56-4705-8a69-b81a77add65c.html,,,,,, 5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid,118-47-8,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0ad7051-f123-4559-acd9-e1fe71650ecc/documents/IUC5-c530cefa-2a13-4cf9-9952-a7666b8efa0e_5806a03b-ab56-4705-8a69-b81a77add65c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,267.276 mg/kg bw/day,,rat 5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid,118-47-8,LD50 was considered as >22000 mg/kg when rats and mouse were treated with of 5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid orally ,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0ad7051-f123-4559-acd9-e1fe71650ecc/documents/IUC5-c233d186-32e0-4ffd-b034-93bc4fa6db3d_5806a03b-ab56-4705-8a69-b81a77add65c.html,,,,,, 5-oxo-1-(4-sulphophenyl)-2-pyrazoline-3-carboxylic acid,118-47-8,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0ad7051-f123-4559-acd9-e1fe71650ecc/documents/IUC5-c233d186-32e0-4ffd-b034-93bc4fa6db3d_5806a03b-ab56-4705-8a69-b81a77add65c.html,,oral,LD50,"22,000 mg/kg bw",no adverse effect observed, 5-oxo-DL-proline,149-87-1,"Short-term repeated dose toxicity In accordance with point 8.6.1, Column 2 (Specific rules for adaptation from Column 1) of Annex VIII, the short-term toxicity study (28-days) does not need to be conducted if a reliable sub-chronic (90-day) study is available. The existing 90-day oral data (conducted on the read across substance) is considered to adequately address the repeated dose toxicity endpoint and a further 28-day study is regarded as unnecessary. The data on the read-across (source) substance is considered representative of the registered (target) substance owing to the structural similarity between the two substances.   Sub-chronic repeated dose toxicity (Read-across from structurally similar substance). Ishii (1992) Under the conditions of the study, repeated oral exposure to the test material over a 26 consecutive week period induced no toxic effects in male or female rats. Therefore the NOAEL can be said to be the maximum daily intake, which was determined to be 7 200 mg/kg bw/day and 8 200 mg/kg bw/day for males and females, respectively. ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0816223c-c809-4ad5-bd9b-83047334c68e/documents/6c23a016-cebd-4ec5-8c81-c79bdf04e788_e38ea1b9-f674-4bf1-b621-895bb6d60161.html,,,,,, 5-oxo-DL-proline,149-87-1,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0816223c-c809-4ad5-bd9b-83047334c68e/documents/6c23a016-cebd-4ec5-8c81-c79bdf04e788_e38ea1b9-f674-4bf1-b621-895bb6d60161.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"7,200 mg/kg bw/day",,rat 5-oxo-DL-proline,149-87-1,"ORAL Supporting study: Ishida (1997) Under the conditions of the study, no change was observed by the single oral administration of 2 000 mg/kg; therefore, the LD50 is above 2 000 mg/kg.   Key Study (read across): Kiss (2012) Under the conditions of the study, no mortalities or signs of toxicity were observed in animals treated at 2 000 mg/kg bw. The LD50 was therefore considered to be greater than 2 000 mg/kg bw.   Supporting study (read across): Ichimura and Kirimura (1969)  Under the conditions of the study, the LD50 was 10.4 g/kg (95 % confidence limit between 9.08 and 11.8 g/kg).   INHALATION In accordance with point 8.5.2, Column 2 (Specific rules for adaptation from Column 1), Annex VIII of Regulation (EC) No. 1907/2006, an acute inhalation study does not need to be performed as use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. The acute toxicity endpoint has been addressed by assessing the toxicity via the oral and dermal routes, which are more appropriate when considering the use pattern of this substance.   DERMAL Key Study (read across): Kiss (2012) Under the conditions of the study on the read-across substance, no mortalities, systemic or local signs of toxicity were observed in animals treated at 2 000 mg/kg bw. The LD50 was therefore considered to be greater than 2 000 mg/kg bw. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0816223c-c809-4ad5-bd9b-83047334c68e/documents/IUC5-f49a2dea-d634-4834-88a9-47e93b28621a_e38ea1b9-f674-4bf1-b621-895bb6d60161.html,,,,,, 5-oxo-DL-proline,149-87-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0816223c-c809-4ad5-bd9b-83047334c68e/documents/IUC5-f49a2dea-d634-4834-88a9-47e93b28621a_e38ea1b9-f674-4bf1-b621-895bb6d60161.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 5-oxo-DL-proline,149-87-1,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0816223c-c809-4ad5-bd9b-83047334c68e/documents/IUC5-f49a2dea-d634-4834-88a9-47e93b28621a_e38ea1b9-f674-4bf1-b621-895bb6d60161.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 5-sulphosalicylic acid,97-05-2," rat, oral, OECD 422, NOAEL = 1000 mg/kg bw/day ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/68661a8d-95f7-4d75-8d48-9b030523aa69/documents/46f984f2-7d97-4ebc-a95d-83c2ddf9dc4a_be77c9d3-f827-4b28-a087-828bf20962a3.html,,,,,, 5-sulphosalicylic acid,97-05-2,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/68661a8d-95f7-4d75-8d48-9b030523aa69/documents/46f984f2-7d97-4ebc-a95d-83c2ddf9dc4a_be77c9d3-f827-4b28-a087-828bf20962a3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 5-sulphosalicylic acid,97-05-2," Based on the pH of 0.55 of the test substance (see reference 4.20-1), the test substance is classified as corrosive to the skin (H314). According to REACH Annex VII and Annex VIII, 8.5 Column 2, no test for acute toxicity is necessary. ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68661a8d-95f7-4d75-8d48-9b030523aa69/documents/bb8c1e81-8fce-4e8e-b4c5-52329f9eea14_be77c9d3-f827-4b28-a087-828bf20962a3.html,,,,,, "6 alpha-Fluoro-16 alpha-methyl-21-valeryloxy-1,4,9(11)-pregnatriene-3,20-dione",66233-43-0," In analogy to fluocortolone, the structurally analogue substance delta-9(11)-fluocortolone-valerate is considered to cause organ damage after repeated administration to test animals. In systemic tolerance studies with fluocortolone involving repeated administration of both subcutaneous and oral doses in rats and dogs for 4 to 80 weeks, typical glucocorticoid effects were observed: degeneration of lymphatic tissue, suppression of the adrenal cortex, impairment of the hematogenic tissue (bone marrow) (Dres et al., 1975; Günzel et al., 1976; Staben, 1979; Woodard et al., 1966, 1967, 1969). ",2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4200d861-43a4-4331-ab32-acf0f561cf7a/documents/4dab4888-47c5-40e4-99d1-128130e500c4_9d106ec1-9d10-45d3-8347-fb26dea45dee.html,,,,,, "6 alpha-Fluoro-16 alpha-methyl-21-valeryloxy-1,4,9(11)-pregnatriene-3,20-dione",66233-43-0,,2025-01-27,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4200d861-43a4-4331-ab32-acf0f561cf7a/documents/4dab4888-47c5-40e4-99d1-128130e500c4_9d106ec1-9d10-45d3-8347-fb26dea45dee.html,Chronic toxicity – systemic effects,oral,LOAEL,0.1 mg/kg bw/day,,rat "6 alpha-Fluoro-16 alpha-methyl-21-valeryloxy-1,4,9(11)-pregnatriene-3,20-dione",66233-43-0,"Delta-9(11)-fluocortolone-valerate is considered to be toxic if swallowed based on an acute rat study (LD50 oral: 245 mg/kg bw) with the read-across substance fluocortolone (Günzel and Richter, 1965). ",2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4200d861-43a4-4331-ab32-acf0f561cf7a/documents/9fd180b4-20f5-40b2-9090-d9b8cf29edbe_9d106ec1-9d10-45d3-8347-fb26dea45dee.html,,,,,, "6 alpha-Fluoro-16 alpha-methyl-21-valeryloxy-1,4,9(11)-pregnatriene-3,20-dione",66233-43-0,,2025-01-27,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4200d861-43a4-4331-ab32-acf0f561cf7a/documents/9fd180b4-20f5-40b2-9090-d9b8cf29edbe_9d106ec1-9d10-45d3-8347-fb26dea45dee.html,,oral,LD50,245 mg/kg bw,adverse effect observed, "6-(dibutylamino)-1,3,5-triazine-2,4(1H,3H)-dithione",29529-99-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22c2ffb1-190b-4e0e-8fa8-75ff6420af36/documents/7056a22e-eadd-4691-923e-9541ce5a4c89_53643a0e-e4d5-4c90-8238-246128739498.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one",89331-94-2,Sub-chronic repeated dose toxicity study with oral administration in rats (OECD TG 408): NOAEL = 1000 mg/kg bw/day  ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f7b18c9f-4ce2-41b3-acb0-8f9c36c95b05/documents/4044deed-f3c4-4690-9873-c19bbd7fca8d_78b2a5fe-3368-4b7c-b6b5-6081b9aaf5e7.html,,,,,, "6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one",89331-94-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f7b18c9f-4ce2-41b3-acb0-8f9c36c95b05/documents/4044deed-f3c4-4690-9873-c19bbd7fca8d_78b2a5fe-3368-4b7c-b6b5-6081b9aaf5e7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one",89331-94-2,Acute oral toxicity (OECD TG 401): LD50 = >5000 mg/kg bw Acute dermal toxicity (OECD TG 403): LD50 = >2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7b18c9f-4ce2-41b3-acb0-8f9c36c95b05/documents/2e9edd29-d65c-417b-955f-cbe049cfa0b2_78b2a5fe-3368-4b7c-b6b5-6081b9aaf5e7.html,,,,,, "6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one",89331-94-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7b18c9f-4ce2-41b3-acb0-8f9c36c95b05/documents/2e9edd29-d65c-417b-955f-cbe049cfa0b2_78b2a5fe-3368-4b7c-b6b5-6081b9aaf5e7.html,,oral,discriminating dose,"5,000 mg/kg bw",adverse effect observed, "6'-(dibutylamino)-3'-methyl-2'-(phenylamino)spiro[isobenzofuran-1(3H),9-(9H)-xanthen]-3-one",89331-94-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7b18c9f-4ce2-41b3-acb0-8f9c36c95b05/documents/2e9edd29-d65c-417b-955f-cbe049cfa0b2_78b2a5fe-3368-4b7c-b6b5-6081b9aaf5e7.html,,dermal,discriminating dose,"2,000 mg/kg bw",adverse effect observed, "6,18-dihydrodinaphtho[2,3-i:2',3'-i']benzo[1,2-a:4,5-a']dicarbazole-5,7,12,17,19,24-hexone",2172-33-0,"Oral: The study considered as key was performed according to OECD Guideline 401. In this study, FAT 46014/F with 35.7% purity was tested on rats by oral administration followed by a 14 day observation period. No mortality was seen at the administered dose of 5000 mg/kg bw. Dyspnoea, exophthalmos, ruffled fur and curved body positions were observed. In addition, a transient diarrhea and tremor was observed. The animals receovered within 10 days. At necropsy, no substance related gross organ changes were seen. Based on the observations, the median lethal dose (LD50) of the test substance in both male and female rats observed for a period of 14 days was >5000 mg/kg bw.   In several other supporting studies, LD50 values of > 10000, >15000 and > 8000 mg/kg were recorded.   The above values show that FAT 46014 is non-toxic via oral route of administration.   Inhalation: Currently no study to assess the acute inhalation toxicity potential of Vat Orange 011 is available. However, the vapour pressure of the substance is considered to be low owing to the high melting point (>350 °C). Hence the substance is considered to have low volatility. Owing to this, the use of this substance will not result in aerosols, particles or droplets of an inhalable size. Synthesis and spray drying of this chemical is performed in a closed process; the final product consists of non-dusty granules. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets. Referring to the expected low volatility of the substance, the fact that the chemical is imported into the EU in a formulated form as a dust-free powder or as a granulate, the exposure via inhalation is considered to be unlikely. Further, no systemic toxicity or mortality were observed in the acute oral toxicity studies with Vat Orange 011 upto 5000 mg/kg bw. Taking into consideration the above information, the acute inhalation exposure is considered to have negligible toxicity potential. Therefore, testing by the inhalation route was considered scientifically not necessary and the intrinsic property/toxicity potential can be extrapolated from the acute oral toxicity study.   Dermal: Currently no study to assess acute dermal toxicity of Vat Orange 011 is available. However, the molecular weight of the substance is 646.6 g/mol, which indicates substance is too large for dermal absorption. Further, referring to the low water solubility of the substance (<1 μg/L), the dermal uptake for the substance is likely to be low as the substance is considered as not sufficiently soluble in water to partition from the stratum corneum into the epidermis. Production and spray drying is performed in closed processes without isolation of reaction products. Isolated products consist either of liquid formulations or of dust free granules (non-dusty solid). In addition, the use of this substance will not result in aerosols, particles or droplets owing to the low vapour pressure, so exposure to humans via the dermal route will be unlikely to occur. The substance showed low toxicity potential in the available acute oral toxicity studies (LD50 >5000 mg/kg bw). Since this route does not result in mortality and/or systemic toxicity up to 5000 mg/kg bw in both male and female rats, systemic toxic effects subsequent to dermal exposure is considered to be unlikely to occur. Similarly, absence of systemic toxicity or mortality in skin irritation as well as sensitization studies, further supports the conclusion that no adverse effects are expected via dermal exposure. Further experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the substance only show up upon dermal exposure and not after systemic application, hence further experiments to assess dermal toxicity are not taken into account. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Good quality guideline study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5eaae9a-6af4-4f96-a9c8-133983f4635a/documents/IUC5-b8d359c9-892e-4fd3-bc7c-9a729b8016fe_0b3bea7b-0aa7-4f52-a970-cfdec8eb327d.html,,,,,, "6,18-dihydrodinaphtho[2,3-i:2',3'-i']benzo[1,2-a:4,5-a']dicarbazole-5,7,12,17,19,24-hexone",2172-33-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5eaae9a-6af4-4f96-a9c8-133983f4635a/documents/IUC5-b8d359c9-892e-4fd3-bc7c-9a729b8016fe_0b3bea7b-0aa7-4f52-a970-cfdec8eb327d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid",80584-91-4,"90-Day NOEL (oral, Sprague-Dawley rats)): >= 1000 mg/kg b.w./day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8474269c-350c-4ad7-998e-f501511f2caa/documents/IUC5-eb50f3e1-8e7e-45d3-9d31-c8804fd45679_b250e26f-5795-4421-85c3-ea0657749323.html,,,,,, "6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid",80584-91-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8474269c-350c-4ad7-998e-f501511f2caa/documents/IUC5-eb50f3e1-8e7e-45d3-9d31-c8804fd45679_b250e26f-5795-4421-85c3-ea0657749323.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid",80584-91-4,Oral LD50 in rats > 5000 mg/kg body weight.Dermal LD50 value > 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8474269c-350c-4ad7-998e-f501511f2caa/documents/IUC5-be615201-f5b8-482a-b598-ae1546e13096_b250e26f-5795-4421-85c3-ea0657749323.html,,,,,, "6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)",80584-92-5," 80584-91-4: In a study according to OECD TG 408, treatment of male and female rats with the triazine compound via gavage for 13 weeks did not result in any effects related to administration. The NOAEL was therefore considered to be 1000 mg/kg body weight. 102-71-6: For triethanolamine, a NOAEL of 1000 mg/kg bw/day was established in a subchronic oral toxicity study. In a sub-chronic dermal toxicity study, NOAELs of 125 and 250 mg/kg bw/day were established for local effects for males and females, respectively. Systemic NOAELs of 125 and 250 mg/kg bw/day were determined for males and females, respectively, based on kidney effects. Similar effects were observed in a sub-chronic dermal study in mice, performed according to the same protocol. In a sub-acute inhalation toxicity study with rats, a NOAEC for systemic effects of 0.5 mg/L was established, the highest dose tested. 0.02 mg/L (the lowest dose tested) was considered to be the NOAEC for local effects in females. Since slight local effects were observed in males, this concentration was determined to be the LOAEC for local effects in males. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30b4c9b0-1114-4090-9854-6dbb4771a33f/documents/IUC5-3aa3d686-6d20-4316-9e91-e36adc206e5f_c8cc22ad-08df-4e1f-a024-2fd755829b39.html,,,,,, "6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)",80584-92-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30b4c9b0-1114-4090-9854-6dbb4771a33f/documents/IUC5-3aa3d686-6d20-4316-9e91-e36adc206e5f_c8cc22ad-08df-4e1f-a024-2fd755829b39.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,500 mg/m3,,rat "6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)",80584-92-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30b4c9b0-1114-4090-9854-6dbb4771a33f/documents/IUC5-3aa3d686-6d20-4316-9e91-e36adc206e5f_c8cc22ad-08df-4e1f-a024-2fd755829b39.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)",80584-92-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30b4c9b0-1114-4090-9854-6dbb4771a33f/documents/IUC5-3aa3d686-6d20-4316-9e91-e36adc206e5f_c8cc22ad-08df-4e1f-a024-2fd755829b39.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,125 mg/kg bw/day,,rat "6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)",80584-92-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30b4c9b0-1114-4090-9854-6dbb4771a33f/documents/IUC5-3aa3d686-6d20-4316-9e91-e36adc206e5f_c8cc22ad-08df-4e1f-a024-2fd755829b39.html,Repeated dose toxicity – local effects,inhalation,LOAEC,20 mg/m3,adverse effect observed,rat "6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)",80584-92-5, The substance is of very low acute toxicity with an oral LD50 of greater than 5000 mg/kg body weight. The dermal LD50 of the individual components was determined to be greater than 2000 mg/kg bw each. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30b4c9b0-1114-4090-9854-6dbb4771a33f/documents/IUC5-482af358-c21e-429b-80a4-19c5140bada2_c8cc22ad-08df-4e1f-a024-2fd755829b39.html,,,,,, "6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)",80584-92-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30b4c9b0-1114-4090-9854-6dbb4771a33f/documents/IUC5-482af358-c21e-429b-80a4-19c5140bada2_c8cc22ad-08df-4e1f-a024-2fd755829b39.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "6,6',6''-(1,3,5-triazine-2,4,6-triyltriimino)trihexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:3)",80584-92-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30b4c9b0-1114-4090-9854-6dbb4771a33f/documents/IUC5-482af358-c21e-429b-80a4-19c5140bada2_c8cc22ad-08df-4e1f-a024-2fd755829b39.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "6,6-dimethylcyclohex-2-en-1-one",6553-64-6, The oral LD50 of the test substance is 500 mg/kg bw in rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6eba7817-dcb3-4f95-b58d-3cca82c6b2a0/documents/6284b5be-d5e7-4b9c-9da5-23f2bd458e06_1506129d-ff9d-4a59-b498-7af59d8daf1f.html,,,,,, "6,6-dimethylcyclohex-2-en-1-one",6553-64-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6eba7817-dcb3-4f95-b58d-3cca82c6b2a0/documents/6284b5be-d5e7-4b9c-9da5-23f2bd458e06_1506129d-ff9d-4a59-b498-7af59d8daf1f.html,,oral,LD50,500 mg/kg bw,no adverse effect observed, "6,6'-di-tert-butyl-2,2'-thiodi-p-cresol",90-66-4," No Observed Adverse Effect Level (NOAEL) of at least 500 mg/kg was derived for 6,6’-di-tert-butyl-2,2’-thiodi-p-cresol test item ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2ad4fec-2d20-4f68-8f03-bd222ac6ea8f/documents/4798ceb6-0853-42ca-aaeb-998abf73c72f_a5f06ac5-91fd-4e32-aafe-67a7b568c414.html,,,,,, "6,6'-di-tert-butyl-2,2'-thiodi-p-cresol",90-66-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2ad4fec-2d20-4f68-8f03-bd222ac6ea8f/documents/4798ceb6-0853-42ca-aaeb-998abf73c72f_a5f06ac5-91fd-4e32-aafe-67a7b568c414.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "6,6'-di-tert-butyl-2,2'-thiodi-p-cresol",90-66-4, Acute Toxicity: Oral LD50 value > 2000 mg/kg bw in female Crl:WI rats. Acute Toxicity: Dermal LD50 value >2000 mg/kg bw in male/female Crl:WI rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2ad4fec-2d20-4f68-8f03-bd222ac6ea8f/documents/a4ae5812-a6ce-41f6-9b90-9a9be6e08a8b_a5f06ac5-91fd-4e32-aafe-67a7b568c414.html,,,,,, "6,6'-di-tert-butyl-2,2'-thiodi-p-cresol",90-66-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2ad4fec-2d20-4f68-8f03-bd222ac6ea8f/documents/a4ae5812-a6ce-41f6-9b90-9a9be6e08a8b_a5f06ac5-91fd-4e32-aafe-67a7b568c414.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "6,6'-di-tert-butyl-2,2'-thiodi-p-cresol",90-66-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2ad4fec-2d20-4f68-8f03-bd222ac6ea8f/documents/a4ae5812-a6ce-41f6-9b90-9a9be6e08a8b_a5f06ac5-91fd-4e32-aafe-67a7b568c414.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "6,6'-di-tert-butyl-4,4'-butylidenedi-m-cresol",85-60-9," Key value determined in compliance with GLP and analytical verification performed, however no reference guidelines detailed in the report. 3 month NOAEL 100 ppm in the rat. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2d5910c-6903-4a38-8bcd-0c19986a519f/documents/IUC5-4e1d1083-ddc4-4d77-97f0-756ecdd8c24c_b32e57a1-9db8-4dd1-9fba-c7c3fe106bcb.html,,,,,, "6,6'-di-tert-butyl-4,4'-butylidenedi-m-cresol",85-60-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2d5910c-6903-4a38-8bcd-0c19986a519f/documents/IUC5-4e1d1083-ddc4-4d77-97f0-756ecdd8c24c_b32e57a1-9db8-4dd1-9fba-c7c3fe106bcb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "6,6'-di-tert-butyl-4,4'-butylidenedi-m-cresol",85-60-9, Acute oral LD50 > 2000 mg/kg bw. Acute dermal LD50 > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2d5910c-6903-4a38-8bcd-0c19986a519f/documents/IUC5-bbf7e35c-d61b-4326-9d93-174e2feb4409_b32e57a1-9db8-4dd1-9fba-c7c3fe106bcb.html,,,,,, "6,6'-di-tert-butyl-4,4'-diethyl-2,2'-methylenediphenol",88-24-4," The oral LD50 of 6,6’-di-tert-butyl-4,4’-diethyl-2,2’-methylenediphenol exceeds 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa12d697-7c6e-4a9c-b2f5-01e3ca56ae28/documents/e34c4823-0488-413b-b5e1-cb5e3260b128_cf52c91a-4bd8-4528-a4ff-3ad832ddecba.html,,,,,, "(1S,5R)-6,8-dioxabicyclo[3.2.1]octan-4-one",53716-82-8," In the key Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test with Cyrene™, conducted according to OECD Test Guideline 422 and in compliance with GLP,  the NOAEL for systemic toxicity was concluded to be at least 1000 mg/kg bw/day based on no adverse systemic effects (Covance Laboratories Ltd., 2018b). A 90-day oral repeated dose toxicity study in rats, according to OECD Test Guideline 408 and in compliance with GLP, has been proposed to be conducted with the registered substance, Cyrene™ ((1S,5R)-6,8-dioxabicyclo[3.2.1]octan-4-one, CAS 53716-82-8, EC 807-130-4) after approval by ECHA. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee229ed7-b29f-4231-b6d3-98d88e3bd3d2/documents/71bdd598-1e5f-4691-bf8d-22da09204d34_7a7bd7a6-9903-451d-8b9b-2e5990b3aaaa.html,,,,,, "(1S,5R)-6,8-dioxabicyclo[3.2.1]octan-4-one",53716-82-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee229ed7-b29f-4231-b6d3-98d88e3bd3d2/documents/71bdd598-1e5f-4691-bf8d-22da09204d34_7a7bd7a6-9903-451d-8b9b-2e5990b3aaaa.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "(1S,5R)-6,8-dioxabicyclo[3.2.1]octan-4-one",53716-82-8," In the key acute oral toxicity study, conducted according to OECD Test Guideline 423 and in compliance with GLP, the concluded LD50 value for the registered substance, Cyrene™, was greater than 2000 mg/kg bw/day (Harlan Laboratories Ltd, 2014a). In the key acute inhalation toxicity study, conducted according to OECD Test Guideline 436 and in compliance with GLP, the concluded LC50 value for Cyrene™ was greater than 5.16 mg/L, equivalent to >5160 mg/m3, following 4-hour nose only exposure of rat to Cyrene™ aerosol at limit concentration (Envigo, 2018a). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee229ed7-b29f-4231-b6d3-98d88e3bd3d2/documents/e5a2759c-c5ac-4e27-9c09-1f8a9c05206e_7a7bd7a6-9903-451d-8b9b-2e5990b3aaaa.html,,,,,, "(1S,5R)-6,8-dioxabicyclo[3.2.1]octan-4-one",53716-82-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee229ed7-b29f-4231-b6d3-98d88e3bd3d2/documents/e5a2759c-c5ac-4e27-9c09-1f8a9c05206e_7a7bd7a6-9903-451d-8b9b-2e5990b3aaaa.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(1S,5R)-6,8-dioxabicyclo[3.2.1]octan-4-one",53716-82-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee229ed7-b29f-4231-b6d3-98d88e3bd3d2/documents/e5a2759c-c5ac-4e27-9c09-1f8a9c05206e_7a7bd7a6-9903-451d-8b9b-2e5990b3aaaa.html,,inhalation,LC50,"5,160 mg/m3",no adverse effect observed, 6-[(1-oxomethyloctyl)amino]hexanoic acid,71902-23-3,There are two reliable 28-day oral toxicity studies in rats available for two different surrogates of the submission substance. Onyl effects observed were species specific effects on the liver as well as species and gender specific effects on the kidney. Mechanistic and histopahtological investigation were conducted to further support this evaluation (hepatic peroxisomal proliferation and alpha2u-globulin accumulation in kidneys). This findings were also obvious in 7-day dose range oral studies available for the submission substance and one other surrogate substance. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b86af231-15c7-4a9c-80de-27b8e2914b93/documents/IUC5-cd20648b-b2f8-4616-84f3-de5561de2dfc_f4fd646e-84c1-4a35-bba9-670dc1ecd49a.html,,,,,, 6-[(1-oxomethyloctyl)amino]hexanoic acid,71902-23-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b86af231-15c7-4a9c-80de-27b8e2914b93/documents/IUC5-cd20648b-b2f8-4616-84f3-de5561de2dfc_f4fd646e-84c1-4a35-bba9-670dc1ecd49a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 6-[(1-oxomethyloctyl)amino]hexanoic acid,71902-23-3,"Single oral application of 2000 mg submission substance per kg body weight via gavage did not cause lethality in male and female Wistar-rats during the 14 day observation period, resulting in an oral LD50 > 2000 mg/kg bw. No data on acute toxicity after inhalation are available. Reliable data from one guideline study on acute toxicity after dermal application is available for the submission substance and a surrogate substance. The LD50 values from these studies are above 2000 mg/kg bw as well. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b86af231-15c7-4a9c-80de-27b8e2914b93/documents/IUC5-70adae55-f3db-424f-8f48-3c42fc6d6b00_f4fd646e-84c1-4a35-bba9-670dc1ecd49a.html,,,,,, 6-[(1-oxomethyloctyl)amino]hexanoic acid,71902-23-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b86af231-15c7-4a9c-80de-27b8e2914b93/documents/IUC5-70adae55-f3db-424f-8f48-3c42fc6d6b00_f4fd646e-84c1-4a35-bba9-670dc1ecd49a.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 6-[(1-oxomethyloctyl)amino]hexanoic acid,71902-23-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b86af231-15c7-4a9c-80de-27b8e2914b93/documents/IUC5-70adae55-f3db-424f-8f48-3c42fc6d6b00_f4fd646e-84c1-4a35-bba9-670dc1ecd49a.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "6-[(2,4-diaminophenyl)azo]-3-[[4-[[4-[[7-[(2,4-diaminophenyl)azo]-1-hydroxy-3-sulpho-2-naphthyl]azo]phenyl]amino]-3-sulphophenyl]azo]-4-hydroxynaphthalene-2-sulphonic acid",76186-07-7," Acute oral toxicity:  Acute oral toxicity dose (LD50) of 6-[(2,4-diaminophenyl)azo]-3-[[4-[[4-[[7-[(2,4-diaminophenyl)azo]-1-hydroxy-3-sulpho-2-naphthyl]azo]phenyl]amino]-3-sulphophenyl]azo] -4-hydroxynaphthalene-2-sulphonic acid (CAS no: 76186-07-7) was predicted based on OECD QSAR toolbox 5215 mg/kg bw; Danish (Q)SAR Database 11000 mg/kg bw; and different studies available on structurally similar read across substances Tetrasodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1- naphthylazo))naphthalene-4,6-disulphonate (CAS No. 2519-30-4) >2000 mg/kg bw and 2-Naphthalenesulfonic acid, 6-[[2-amino-4-[(2-hydroxyethyl)amino]phenyl]azo]-3- [[4-[[4-[[7-[[2-amino-4-[(2-hydroxyethyl)amino] phenyl]azo]-1-hydroxy-3-sulfo-2-naphthalenyl] azo]phenyl]amino]-3-sulfophenyl]azo]-4-hydroxy-, trisodium salt (CAS no: 6428-38-2) >10000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 6-[(2,4-diaminophenyl)azo]-3-[[4-[[4-[[7-[(2,4-diaminophenyl)azo]-1-hydroxy-3-sulpho-2-naphthyl]azo]phenyl]amino]-3-sulphophenyl]azo]-4-hydroxynaphthalene-2-sulphonic acid cannot be classified for acute oral toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b48c62ad-0277-4cc7-bdb5-b093839a9e8d/documents/39510269-5517-4e8d-8443-579009e0eeb1_9c5b6280-4ef1-489c-b15c-625d5a1af590.html,,,,,, "6-[(2,4-diaminophenyl)azo]-3-[[4-[[4-[[7-[(2,4-diaminophenyl)azo]-1-hydroxy-3-sulpho-2-naphthyl]azo]phenyl]amino]-3-sulphophenyl]azo]-4-hydroxynaphthalene-2-sulphonic acid",76186-07-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b48c62ad-0277-4cc7-bdb5-b093839a9e8d/documents/39510269-5517-4e8d-8443-579009e0eeb1_9c5b6280-4ef1-489c-b15c-625d5a1af590.html,,oral,LD50,"5,215 mg/kg bw",no adverse effect observed, "6-[(p-tosyl)amino]hexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)",93981-14-7,"The repeated dose toxicity of the carboxylic acid component of the registered substance (tosyl salt) to rats was determined via the oral route of exposure in accordance with the OECD Guideline for Testing of Chemicals 422 (Short term repeated dose toxicity) and OECD TG 408 (Sub-chronic 90-day toxicity). As a result of the OECD 422, the NOEL and NOAEL for the test substance is defined as 400 mg/kg bw/day. The LOAEL for the test substance is defined as 1600 mg/kg bw/day. As a result of the OECD TG 408, the no-observed-adverse-effect-level (NOAEL) is considered 100 mg/kg bw/day for males and 1600 mg/kg bw/day for females. No studies were conducted to determine the repeated dose toxicity via inhalation or dermal exposure as, owing to the physical properties and usage of the substance, it was considered unlikely that inhalation or dermal exposure would occur, therefore making it unjustifiable to perform further animal testing. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/185c393d-32cd-4bf8-9afc-b667797bc6f0/documents/IUC5-fa4d38e9-554f-409d-a507-05091f2b878c_0385d794-ee07-45d3-9a3d-967e355562ae.html,,,,,, "6-[(p-tosyl)amino]hexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)",93981-14-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/185c393d-32cd-4bf8-9afc-b667797bc6f0/documents/IUC5-fa4d38e9-554f-409d-a507-05091f2b878c_0385d794-ee07-45d3-9a3d-967e355562ae.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "6-[(p-tosyl)amino]hexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)",93981-14-7,"Acute toxicity oral and dermal studies have been conducted on the parent carboxylic acid of the tosyl salt (the registered substance) which is the component of the tosyl salt which will have a more significant impact on the environment based on the limited toxicity of triethanolamine. Both studies found that there was no toxic effect up to a dose rate of 2000 mg/kg bw/day, as such the substance is not classified as an Acute Oral Toxin or an Acute Dermal Toxin in accordance with EU CLP criteria. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/185c393d-32cd-4bf8-9afc-b667797bc6f0/documents/IUC5-fd0f46a4-b8b7-4d7d-b13d-0df2aefac13a_0385d794-ee07-45d3-9a3d-967e355562ae.html,,,,,, "6-[(p-tosyl)amino]hexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)",93981-14-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/185c393d-32cd-4bf8-9afc-b667797bc6f0/documents/IUC5-fd0f46a4-b8b7-4d7d-b13d-0df2aefac13a_0385d794-ee07-45d3-9a3d-967e355562ae.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "6-[(p-tosyl)amino]hexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)",93981-14-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/185c393d-32cd-4bf8-9afc-b667797bc6f0/documents/IUC5-fd0f46a4-b8b7-4d7d-b13d-0df2aefac13a_0385d794-ee07-45d3-9a3d-967e355562ae.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid,78521-39-8,"Daily dosages of 0, 100, 400, and 1600 mg ASC plus/kg bw. were administered by stomach tube to groups of 12 male rats for 54 days (Zeljenkova, D, 2013). Satellite animals in a control and the highest dose group (1600mg/kg bw) with 5 individual each were also included. The test-article was formulated in drinking water and administered in 10 ml/kg bw. At dosages of 100 and 400 mg/kg bw. the animals showed no differences to the control animals (NOAEL). 1600 mg ASC plus/kg bw., considered as the LOEL may have induced an influence on the body weight gain of the males (and the survival of pups until day 4 after birth). The NOAEL of 400 mg/kg bw/day based on influence on the body weight gain of the males (and the survival of pups until day 4 after birth).   OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents): Dosages of 0, 100, 400 and 1600 mg/kg bw/day of ASCplus® in 10 ml/kg bw destilled water were administered by gavage to groups of 10 male and female Sprague-Dawley rats for 90 days. Additional groups of 6 male and 6 female animals were given dosages of 0 and 1600 mg/kg bw for 90 days followed by a 21 day recovery period. The administration volume was 10 ml/kg bw (Oksana N. Khokhiova 2021). No mortality was observed. No treatment related changes were found in the clinical observation, the body weights, the food consumption, the ophthalmological examinations and in the Functional Observation Battery.The following treatment-related changes were observed:Males, 400 mg/kg bw/day: increased serum urea, testes, Leydig cells hyperplasia;Males, 1600 mg/kg bw/day: increased urobilinogen, decreased urine pH, decreased serum triglyceride, increased serum urea, increased liver weights and kidney weights; liver, fatty change; kidney, lipofuscinosis; thyroid glands, C-cell hyperplasia; testes, Leydig cells hyperplasia;Females, 400 mg/kg bw/day: decreased APTT, increased liver weights; liver, fatty change; kidney, lipofuscinosis, calculi in pelvis; thyroid glands, C-cell hyperplasia;Females, 1600 mg/kg bw/day: increased urobilinogen, decreased: APTT, increased liver weights and kidney weights; liver, fatty change, hepatocellular hypertrophy; thyroid glands, C-cell hyperplasia.Therefore, under the conditions of this study, the no-observed-adverse-effect-level (NOAEL) is considered 100 mg/kg bw/day for males and 100 mg/kg bw/day for females.   NOEL: >=100 mg/kg bw/day (nominal) (male) based on: (test mat.) clinical biochemistry NOEL: >=400 mg/kg bw/day (nominal) (male) based on: (test mat.) organ weights and organ / body weight ratios NOEL: >=1600 mg/kg bw/day (nominal) (female) based on: (test mat.) clinical biochemistry NOEL: >=1600 mg/kg bw/day (nominal) (male) based on: (test mat.) haematology NOEL: >=100 mg/kg bw/day (nominal) (female) based on: (test mat.) haematology ; organ weights and organ / body weight ratios NOEL: >=1600 mg/kg bw/day (nominal) (male/female) based on: (test mat.) behaviour (functional findings) ; body weight and weight gain ; clinical signs ; dermal irritation ; gross pathology ; histopathology: neoplastic ; immunology ; mortality ; neuropathology ; ophthalmological examination ; serum/plasma hormone analyses (not measured/tested - food consumption, food efficiency, sperm measures, immunological findings, neuropathology findings) NOEL: >=400 mg/kg bw/day (nominal) (male/female) based on: (test mat.) urinalysis   Evaluation of target organ toxicity: Lowest effective dose /concentration: hepatobiliary : kidney ; liver ; testes ; thyroid gland (lowesteffective dose/conc.: 400 mg/kg bw (total dose); treatment-related ; dose-response: yes) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable, according to OECD Guidelines under GLP ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1de080ec-59e2-4ad8-ac34-3b03c77aa62a/documents/IUC5-6635d201-7ffc-4eff-8e7c-7bb3ee69a58c_09ed0a00-5442-4ac5-99c5-e2e351636fb7.html,,,,,, 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid,78521-39-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1de080ec-59e2-4ad8-ac34-3b03c77aa62a/documents/IUC5-6635d201-7ffc-4eff-8e7c-7bb3ee69a58c_09ed0a00-5442-4ac5-99c5-e2e351636fb7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid,78521-39-8,LD50 (dermal and oral) >= 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1de080ec-59e2-4ad8-ac34-3b03c77aa62a/documents/IUC5-cbb954d0-6815-4522-a3b8-4a1f4717506d_09ed0a00-5442-4ac5-99c5-e2e351636fb7.html,,,,,, 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid,78521-39-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1de080ec-59e2-4ad8-ac34-3b03c77aa62a/documents/IUC5-cbb954d0-6815-4522-a3b8-4a1f4717506d_09ed0a00-5442-4ac5-99c5-e2e351636fb7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 6-[[(4-methylphenyl)sulphonyl]amino]hexanoic acid,78521-39-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1de080ec-59e2-4ad8-ac34-3b03c77aa62a/documents/IUC5-cbb954d0-6815-4522-a3b8-4a1f4717506d_09ed0a00-5442-4ac5-99c5-e2e351636fb7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "6-[methyl(phenylsulphonyl)amino]hexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)",26919-50-6,"The sub-chronic toxicity (90-day) via the oral route of the registered substance was determined via expert assessment. It is expected that the substance will dissociate following an exposure event and, therefore, its potential toxic effect will be driven by the toxicity of its constituents 6-[methyl(phenylsulphonyl)amino] hexanoic acid (MPSAH) and triethanolamine (TEA). No data is available on the capacity of MPSAH to induce repeated dose toxicity. The data availability for MPSAH is limited to only water solubility, partition coefficient, dissociation constant, acute oral toxicity, and skin and eye irritation. Based on the available data, MPSAH demonstrates a remarkable similarity to a structurally similar substance 6-[[(4-methylphenyl) sulphonyl] amino] hexanoic acid (4-MPSAH; EC 278-934-5). Since no toxicological difference is expected between MPSAH and 4-MPSAH, an expert assessment was conducted based on available experimental data on the analogue 4-MPSAH. In addition, TEA data was also used as a source for further support.  4-MPSAH was tested for its potential to cause sub-chronic toxicity (90-day) via the oral route, in accordance with the OECD Guideline for Testing of Chemicals 408 (Repeated Dose 90-Day Oral Toxicity Study in Rodents). The test item as a suspension in the vehicle (distilled water), was administered by gavage once daily to three groups of Sprague-Dawley rats starting from the age of 6-7 weeks at the doses 100, 400 and 1600 mg/kg body weight (kg/bw/day) for 90 days. Male rats appeared to be more sensitive to the test substance in this study, therefore, under the conditions of this study, the no-observed-adverse-effect-level (NOAEL) was considered 100 mg/kg bw/day for males and 1600 mg/kg bw/day for females. Although the NOAEL derived for the substance in male rats is 100 mg/kg bw/day, the adverse effects observed in the study are not severe enough to justify classification in Specific target organ toxicity - repeated (STOT-RE) category under GHS and CLP. TEA was tested for its potential to cause sub-chronic toxicity (90-day) via the oral route , in accordance with the OECD Guideline for Testing of Chemicals 408.TEA did not induce sub-chronic toxicity when administered via the oral route in females and males’ rats up to 1000 mg/kg bw/day, the highest dose tested. The repeated dose short term toxicity of the registered substance was determined via read-across to the results of testing with 4-MPSAH. 4-MPSAH was tested in accordance with the OECD Guideline for Testing of Chemicals 422. Doses of 0, 100, 400, and 1600 mg/kg bw/day of the test substance were administered by stomach tube to groups of 12 male rats for 54 days. The test-article was formulated in drinking water and administered in 10 ml/kg bw. At dosages of 100 and 400 mg/kg bw/day the animals showed no differences to the control animals (NOEL). All examined organs and tissues showed a normal histological structure. 1600 mg/kg bw/day may have induced an influence on the body weight gain of the males (and the survival of pups until day 4 after birth). The NOEL and NOAEL for the test substance is defined as 400 mg/kg bw/day. The LOEL for the test substance is defined as 1600 mg/kg bw/day. No studies were conducted to determine the repeated dose toxicity via inhalation or dermal exposure as, owing to the physical properties and usage of the substance, it was considered unlikely that inhalation or dermal exposure would occur, therefore making it unjustifiable to perform further animal testing. According to the activity of the acid and amine component, the evidence reviewed in this endpoint assessment report suggests that 6-[methyl(phenylsulphonyl)amino]hexanoic acid and triethanolamine are not expected to induce sub-chronic toxicity via the oral route, and as such the substance 6-[methyl(phenylsulphonyl)amino]hexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) (N-methyl salt) is not expected to induce sub-chronic toxicity via the oral route. An experimental study is subsequently not required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96429bc6-d770-419e-a259-edaadee71d03/documents/IUC5-b158e0d1-9b12-4a71-abc4-6e9aa93766cc_df60ae30-6f2c-48bc-8156-cc84502bad81.html,,,,,, "6-[methyl(phenylsulphonyl)amino]hexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)",26919-50-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96429bc6-d770-419e-a259-edaadee71d03/documents/IUC5-b158e0d1-9b12-4a71-abc4-6e9aa93766cc_df60ae30-6f2c-48bc-8156-cc84502bad81.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "6-[methyl(phenylsulphonyl)amino]hexanoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)",26919-50-6,"The test substance did not cause any symptoms of toxicity after an oral dosage of 2000mg/kg. Therefore, the LD50 was reported as >2000 mg/kg bw/day, and the substance does not require classification as an acute oral toxin according to EU CLP criteria. A single dermal administration of 2000 mg/kg bw of the test substance to 5 male and 5 female rats did not cause any sign of systemic toxicity or dermal irritation were observed. The LD50 of the test substance was reported as >2000 mg/kg bw/day, therefore the substance does not require classification as an acute dermal toxin according to EU CLP criteria. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96429bc6-d770-419e-a259-edaadee71d03/documents/IUC5-9861b25e-af74-4727-b4ca-083dbbd5bc40_df60ae30-6f2c-48bc-8156-cc84502bad81.html,,,,,, "2-Propenoic acid, 2-methyl-,6-[4-[(1E)-3-methoxy-3-oxo-1-propenyl]phenoxy]hexyl ester",439661-46-8," The LD50 of the test item ROC-601 is higher than 2000 mg/kg body weight after single oral administration to Wistar rats. Based on Annex 2d Test Procedure of OECD Guideline 423 with a Starting Dose of 2000 mg/kg body weight, and recognizing no mortality or adverse effects in any of the animals used at that dose (0/6 moribund or dead animals), it can be concluded that the test item ROC-601 is unclassified according to GHS with a LD50 cut off value equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0492e50d-06f4-4117-844a-61511cc3732c/documents/5fa22551-0507-43e2-a18d-13e153e66e50_3d14b9a3-94b8-4174-ba05-d337c9b2d35b.html,,,,,, "2-Propenoic acid, 2-methyl-,6-[4-[(1E)-3-methoxy-3-oxo-1-propenyl]phenoxy]hexyl ester",439661-46-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0492e50d-06f4-4117-844a-61511cc3732c/documents/5fa22551-0507-43e2-a18d-13e153e66e50_3d14b9a3-94b8-4174-ba05-d337c9b2d35b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "6-amino-1,3-dimethyluracil",6642-31-5," Repeated Dose Toxicity: Subchronic (90 day + 28 day recovery) study oral (feed), Wistar rat m/f, 0, 500, 2000, 10000 ppm in diet, corresponding to approx. 0, 25, 110, 700 mg/kg bw/d (OECD 408, GLP): NOEL = 2000 ppm / ca. 110 mg/kg bw/d (based on clinical signs, body weight (gain), food consumption, clinical biochemistry, organ weights, histopathology) NOAEL = 2000 ppm / ca. 110 mg/kg bw/d (based on clinical biochemistry, histopathology) Total protein and globulin were decreased and albumin/globulin ratio was increased in males and females receiving 10000 ppm. These changes were still observed for males of this group after 17 weeks. In the cortex of the adrenal glands an increased incidence of minor (minimal or slight) degrees of vacuolation of the zona glomerulosa was recorded in 10000 ppm treated rats of both sexes (males 8/10, females 10/10). Following the recovery period, this finding was still present at minimal or slight degrees in 5/10 males and 6/10 females of the 10000 ppm treated groups ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e15d20d7-922b-44a3-9bea-1e0ce9d32f04/documents/936c7531-f1f6-4ceb-97e4-86acc1f5db19_c43fbc84-7192-44f2-8b6d-bb7186d2f5bd.html,,,,,, "6-amino-1,3-dimethyluracil",6642-31-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e15d20d7-922b-44a3-9bea-1e0ce9d32f04/documents/936c7531-f1f6-4ceb-97e4-86acc1f5db19_c43fbc84-7192-44f2-8b6d-bb7186d2f5bd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,110 mg/kg bw/day,,rat "6-amino-1,3-dimethyluracil",6642-31-5," Acute toxicity oral: Wistar rat m/f, 5/sex, oral: gavage, 5000 mg/kg in 0.5% aqueous carboxymethyl cellulose, similar to OECD 401: LD50 > 5000 mg/kg, LD0 ≥ 5000 mg/kg, no abnormalities noted Acute toxicity dermal: Wistar rat m/f, 5/sex, 2000 mg/kg in water, semi-occlusive, 24h exposure, OECD 402, GLP: LD50 > 2000 mg/kg, LD0 ≥ 2000 mg/kg, no abnormalities noted ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e15d20d7-922b-44a3-9bea-1e0ce9d32f04/documents/18a3386d-9e2b-47e2-91c1-9e1d41eea0e6_c43fbc84-7192-44f2-8b6d-bb7186d2f5bd.html,,,,,, "6-amino-1,3-dimethyluracil",6642-31-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e15d20d7-922b-44a3-9bea-1e0ce9d32f04/documents/18a3386d-9e2b-47e2-91c1-9e1d41eea0e6_c43fbc84-7192-44f2-8b6d-bb7186d2f5bd.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "6-amino-1,3-dimethyluracil",6642-31-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e15d20d7-922b-44a3-9bea-1e0ce9d32f04/documents/18a3386d-9e2b-47e2-91c1-9e1d41eea0e6_c43fbc84-7192-44f2-8b6d-bb7186d2f5bd.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "6-aminonaphthalene-1,3-disulphonic acid",118-33-2," Acute toxicity: oral The acute toxicity study was conducted to evaluate the toxic effects of administration of 6-aminonaphthalene-1,3-disulphonic acid (CAS No. 118-33-2) in rat by the oral route. 50% mortality was observed at 2000 mg/kg bw in treated rats. Therefore, the acute oral median lethal dose (LD50) of 6-aminonaphthalene- 1,3-disulphonic acid in rat was observed to be 2000 mg/kg b.wt. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0ec4af0-7f19-429e-a43c-e42e40ce6608/documents/e2c8263b-a3a6-4ecb-89f0-1f9eb7a7dada_42d12808-4661-4334-bd54-cbe790b175c0.html,,,,,, "6-aminonaphthalene-1,3-disulphonic acid",118-33-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0ec4af0-7f19-429e-a43c-e42e40ce6608/documents/e2c8263b-a3a6-4ecb-89f0-1f9eb7a7dada_42d12808-4661-4334-bd54-cbe790b175c0.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, 6-aminonaphthalene-2-sulphonic acid,93-00-5," Repeated dose toxicity: Oral The No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg/day for test substance  in male and female rats during subchronic repeated dose toxicity study. Repeated dose toxicity: inhalation  According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 6-aminonaphthalene-2-sulphonic acid, which is reported as 7.01E-008 Pa. Also considering the particle size distribution of the substance, the majority of the particles were found to be in the size of 150.0 micrometer which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical 6-aminonaphthalene-2-sulphonic acid is highly unlikely. Therefore this study is considered for waiver. Repeated dose toxicity: dermal The acute toxicity value for 6-aminonaphthalene-2-sulphonic acid (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not irritating to skin. Also, given the use of the chemical as dye intermediate and used for all kinds of dye products; repeated exposure by the dermal route is unlikely. Thus, it is expected that 6-aminonaphthalene-2-sulphonic acid shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no dermal absorption data as well as no data available that suggests that 6-aminonaphthalene-2-sulphonic acid shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/abb34b22-de65-4da2-b2e7-e4e30e417f09/documents/5cf50043-0eed-4e12-8eed-b3a668beaf70_4db9d33a-437e-4b23-a328-2f78135593f0.html,,,,,, 6-aminonaphthalene-2-sulphonic acid,93-00-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/abb34b22-de65-4da2-b2e7-e4e30e417f09/documents/5cf50043-0eed-4e12-8eed-b3a668beaf70_4db9d33a-437e-4b23-a328-2f78135593f0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 6-aminonaphthalene-2-sulphonic acid,93-00-5," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical.The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity.Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.  Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.0000000701 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The study concluded that the LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abb34b22-de65-4da2-b2e7-e4e30e417f09/documents/IUC5-6b26108b-dcdf-4119-9cbf-983e91a9a0b8_4db9d33a-437e-4b23-a328-2f78135593f0.html,,,,,, 6-aminonaphthalene-2-sulphonic acid,93-00-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abb34b22-de65-4da2-b2e7-e4e30e417f09/documents/IUC5-6b26108b-dcdf-4119-9cbf-983e91a9a0b8_4db9d33a-437e-4b23-a328-2f78135593f0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 6-aminonaphthalene-2-sulphonic acid,93-00-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abb34b22-de65-4da2-b2e7-e4e30e417f09/documents/IUC5-6b26108b-dcdf-4119-9cbf-983e91a9a0b8_4db9d33a-437e-4b23-a328-2f78135593f0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "6-chloro-5-(2-chloroethyl)-1,3-dihydroindol-2-one",118289-55-7,One acute oral toxicity study and two dermal toxicity studies completed.  All studies indicate substance is not classified with LD 50 > 2000 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccc66a0c-eee7-436d-84f8-4291e723b830/documents/IUC5-20de43fa-23f5-43f7-aab7-7cb4fea3a20d_fbe8c151-c5c9-487c-b5a5-82368b801b8e.html,,,,,, "6-chloro-5-(2-chloroethyl)-1,3-dihydroindol-2-one",118289-55-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccc66a0c-eee7-436d-84f8-4291e723b830/documents/IUC5-20de43fa-23f5-43f7-aab7-7cb4fea3a20d_fbe8c151-c5c9-487c-b5a5-82368b801b8e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "6-chloro-5-(2-chloroethyl)-1,3-dihydroindol-2-one",118289-55-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccc66a0c-eee7-436d-84f8-4291e723b830/documents/IUC5-20de43fa-23f5-43f7-aab7-7cb4fea3a20d_fbe8c151-c5c9-487c-b5a5-82368b801b8e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 6-chlorohexan-2-one,10226-30-9,The test compound hydratopic aldehyde can be considered to be not toxic upon repeated exposure by oral route. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f55a6ba-377d-4d02-b935-3d65b7d553f2/documents/IUC5-8c9c89a2-8410-406c-b80f-cbfdcd14017f_4d5fac42-3246-43e0-8e49-3679bdc9f8ac.html,,,,,, 6-chlorohexan-2-one,10226-30-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f55a6ba-377d-4d02-b935-3d65b7d553f2/documents/IUC5-8c9c89a2-8410-406c-b80f-cbfdcd14017f_4d5fac42-3246-43e0-8e49-3679bdc9f8ac.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,762.843 mg/kg bw/day,,rat 6-chlorohexan-2-one,10226-30-9,"The substance 6-chlorohexan-2-one is determined to be non-toxic by oral, inhalative and dermal route of exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f55a6ba-377d-4d02-b935-3d65b7d553f2/documents/IUC5-f3f12d68-9f98-47ec-97ca-6950f80edc90_4d5fac42-3246-43e0-8e49-3679bdc9f8ac.html,,,,,, 6-chlorohexan-2-one,10226-30-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f55a6ba-377d-4d02-b935-3d65b7d553f2/documents/IUC5-f3f12d68-9f98-47ec-97ca-6950f80edc90_4d5fac42-3246-43e0-8e49-3679bdc9f8ac.html,,oral,LD50,"2,608.43 mg/kg bw",no adverse effect observed, 6-chlorohexan-2-one,10226-30-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f55a6ba-377d-4d02-b935-3d65b7d553f2/documents/IUC5-f3f12d68-9f98-47ec-97ca-6950f80edc90_4d5fac42-3246-43e0-8e49-3679bdc9f8ac.html,,dermal,LD50,"3,562.54 mg/kg bw",no adverse effect observed, 6-chlorohexan-2-one,10226-30-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f55a6ba-377d-4d02-b935-3d65b7d553f2/documents/IUC5-f3f12d68-9f98-47ec-97ca-6950f80edc90_4d5fac42-3246-43e0-8e49-3679bdc9f8ac.html,,inhalation,LC50,"24,980 mg/m3",no adverse effect observed, 6-chlorohexyl 2-methylprop-2-enoate,45101-66-4, 6-chlorohexyl methacrylate is expected to be of low repeated toxicity for all routes based on its similarity with short chain alkyl methacrylates. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6a3f193-6630-4b0c-82d4-f030a6a0541a/documents/bcdb0b17-1ad8-44f7-ab94-3cc540e31fb8_782fb186-955e-4f2b-8f1d-2fdae32e5bf9.html,,,,,, 6-chlorohexyl 2-methylprop-2-enoate,45101-66-4, 6-chlorohexyl methacrylate is expected to be of low acute toxicity for all routes based on its similarity with short chain alkyl methacrylates. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6a3f193-6630-4b0c-82d4-f030a6a0541a/documents/5fedd347-19c5-41e8-8eb3-88022cf6f7bb_782fb186-955e-4f2b-8f1d-2fdae32e5bf9.html,,,,,, 6-cyclopentylidenehexanal,111998-18-6,"Oral LD50 > 300 mg/kg bw - < 2000 mg/kg bw. The LD50 cut-off: 1000 mg/kg bw (OECD 423, K, Rel.1) Dermal LD50 > 2000 mg/kg bw (OECD 402, K, Rel.1) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The key study is GLP compliant and of high quality. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The key study is GLP compliant and of high quality. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93779e22-b1e0-40fb-96ab-cfca3a824b34/documents/2cce940e-54be-4fcb-8f64-504cb0236ae6_c24f6efe-dcbf-4113-96eb-c4d4cc389166.html,,,,,, 6-cyclopentylidenehexanal,111998-18-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93779e22-b1e0-40fb-96ab-cfca3a824b34/documents/2cce940e-54be-4fcb-8f64-504cb0236ae6_c24f6efe-dcbf-4113-96eb-c4d4cc389166.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, 6-cyclopentylidenehexanal,111998-18-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93779e22-b1e0-40fb-96ab-cfca3a824b34/documents/2cce940e-54be-4fcb-8f64-504cb0236ae6_c24f6efe-dcbf-4113-96eb-c4d4cc389166.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "6-diazo-5,6-dihydro-5-oxonaphthalene-2-sulphonyl chloride",3770-97-6," RA to OECD 422: parental NOAEL (42 d, oral, rat) = 200 mg/kg bw/d ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c11acaf-7055-4b84-81f3-b772cd95d463/documents/6eda53f2-4eba-4e7b-a7c1-2002c0462c9f_aa3e7fa5-64a2-4b5d-8f5f-d378e7f3fe91.html,,,,,, "6-diazo-5,6-dihydro-5-oxonaphthalene-2-sulphonyl chloride",3770-97-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c11acaf-7055-4b84-81f3-b772cd95d463/documents/6eda53f2-4eba-4e7b-a7c1-2002c0462c9f_aa3e7fa5-64a2-4b5d-8f5f-d378e7f3fe91.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "6-diazo-5,6-dihydro-5-oxonaphthalene-2-sulphonyl chloride",3770-97-6," OECD 401: LD50 (oral, rat) 300 - 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c11acaf-7055-4b84-81f3-b772cd95d463/documents/4a1e3373-fe0e-435c-9e38-a5fac2e93fa0_aa3e7fa5-64a2-4b5d-8f5f-d378e7f3fe91.html,,,,,, "6-diazo-5,6-dihydro-5-oxonaphthalene-2-sulphonyl chloride",3770-97-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c11acaf-7055-4b84-81f3-b772cd95d463/documents/4a1e3373-fe0e-435c-9e38-a5fac2e93fa0_aa3e7fa5-64a2-4b5d-8f5f-d378e7f3fe91.html,,oral,LD50,"1,250 mg/kg bw",adverse effect observed, "6-dimethylamino-3,3-bis(4-dimethylaminophenyl)phthalide",1552-42-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eac0114e-7892-49ee-b821-84aef756f747/documents/c3c26a67-9f1f-4553-8060-1b3ef7c2aa8d_2b374ee9-1a79-4dfe-845c-20b9a90dab09.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat "6-dimethylamino-3,3-bis(4-dimethylaminophenyl)phthalide",1552-42-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eac0114e-7892-49ee-b821-84aef756f747/documents/795fe0cd-23a2-400d-9824-f62b3b956820_2b374ee9-1a79-4dfe-845c-20b9a90dab09.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 6-ethyl-2-toluidine,24549-06-2,"According to the findings of the subacute oral toxicity study a LOAEL of 221 mg/kg body weight can be determined, but with the restriction that the study has limitations concerning dosage and observation parameters compared to the guideline study. No classification is required according to the available data base. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7ce1311-10c0-46cb-a82a-27449db0bd8e/documents/IUC5-3d3780df-b0d6-4e33-9b26-2f02c7ab7b0a_8c4c8d76-f437-4ce7-b3d4-ea2bb38cca70.html,,,,,, 6-ethyl-2-toluidine,24549-06-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7ce1311-10c0-46cb-a82a-27449db0bd8e/documents/IUC5-3d3780df-b0d6-4e33-9b26-2f02c7ab7b0a_8c4c8d76-f437-4ce7-b3d4-ea2bb38cca70.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,221 mg/kg bw/day,, 6-ethyl-2-toluidine,24549-06-2,The oral LD50 for rats of 2-methyl-6-ethylaniline in these acute oral toxicity studies is found within 885 to 1700 mg/kg body weight.The LC50 for 2-methyl-6-ethylaniline is 2.6 mg/l/ 4 h in air.The dermal LD50 is 1290 mg/kg bw in rabbits. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7ce1311-10c0-46cb-a82a-27449db0bd8e/documents/IUC5-b130553e-f6a2-4645-890a-c46c0a86170e_8c4c8d76-f437-4ce7-b3d4-ea2bb38cca70.html,,,,,, 6-ethyl-2-toluidine,24549-06-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7ce1311-10c0-46cb-a82a-27449db0bd8e/documents/IUC5-b130553e-f6a2-4645-890a-c46c0a86170e_8c4c8d76-f437-4ce7-b3d4-ea2bb38cca70.html,,oral,LD50,885 mg/kg bw,, 6-ethyl-2-toluidine,24549-06-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7ce1311-10c0-46cb-a82a-27449db0bd8e/documents/IUC5-b130553e-f6a2-4645-890a-c46c0a86170e_8c4c8d76-f437-4ce7-b3d4-ea2bb38cca70.html,,dermal,LD50,"1,290 mg/kg bw",, 6-ethyl-2-toluidine,24549-06-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7ce1311-10c0-46cb-a82a-27449db0bd8e/documents/IUC5-b130553e-f6a2-4645-890a-c46c0a86170e_8c4c8d76-f437-4ce7-b3d4-ea2bb38cca70.html,,inhalation,LC50,"2,600 mg/m3",, 6-ethyl-5-fluoro-4(3H)-pyrimidone,137234-87-8," Repeated oral toxicity: This study was performed to assess the potential systemic toxicity of test item to CD rats based on OECD 407. Treatment-related effects, indicative of toxicity, were seen for both sexes at 500 mg/kg/day. The degree of toxicity was not marked, given that overall, effects were reversible after two weeks without treatment. The parameters noted for both sexes at 150 mg/kg/day may have been related to treatment, though with no pathological changes detected this was uncertain. The degree of the differences was small too, indicated by reduced statistical significance. Hence, whilst not a NOEL (no observed effect level), it is considered this dosage is a NOAEL (no observed adverse effect level). For 50 mg/kg/day, the only parameter of note, AP for females, was, after consideration of the small degree of difference and inter-individual variation not considered to be treatment-related or biologically relevant and hence this dosage is a NOEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39bf1b49-3929-430b-8c6c-701d38931bc4/documents/ac64441a-3db8-40b8-b710-befbafc485f3_8c615638-affc-4149-8df5-74cf252ba5fd.html,,,,,, 6-ethyl-5-fluoro-4(3H)-pyrimidone,137234-87-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39bf1b49-3929-430b-8c6c-701d38931bc4/documents/ac64441a-3db8-40b8-b710-befbafc485f3_8c615638-affc-4149-8df5-74cf252ba5fd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat 6-ethyl-5-fluoro-4(3H)-pyrimidone,137234-87-8, Oral: A study was performed to assess the acute oral toxicity of test item to the rat following the method described in EC B.1. The discriminating oral dose to rats of test item was established to be 500 mg/kg bodyweight. Dermal: A study was performed to assess the acute dermal toxicity of test item to the rat following the method described in OECD 402. The acute lethal dermal dose to rats of test item was demonstrated to be greater than 2000 mg/kg bodyweight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39bf1b49-3929-430b-8c6c-701d38931bc4/documents/f7fd68c4-9db2-44a4-8669-822dddbc05db_8c615638-affc-4149-8df5-74cf252ba5fd.html,,,,,, 6-ethyl-5-fluoro-4(3H)-pyrimidone,137234-87-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39bf1b49-3929-430b-8c6c-701d38931bc4/documents/f7fd68c4-9db2-44a4-8669-822dddbc05db_8c615638-affc-4149-8df5-74cf252ba5fd.html,,oral,LD50,500 mg/kg bw,no adverse effect observed, "6-fluoro-3-(piperidin-4-yl)-1,2-benzoxazole hydrochloride",84163-13-3,"Acute toxicity: Oral In an acute oral toxicity study in female Wistar rats, following the acute toxic class method in accordance with the OECD Guideline 423 and EU Method B.1 tris (Ott M; 2006), the LD50 of T001492 was established to be within the range of 300 - 2000 mg/kg bw. T001492 was found to be slightly toxic by the oral route and should be classified as Category 4 according to CLP regulation (EC) No 1272/2008.   In an acute oral toxicity study in rats, the LD50 of T001492 was found to be 77.10 (58.99 - 100.8) mg/kg (Janssen; 1988).   In a 5-day range-finding oral toxicity study in male and female Wistar rats, dose levels of 10, 30 or 100 mg/kg bw are proposed for the subsequent 28-day study with T001492 (RCC; 2006).   The studies  were used in a weight-of-evidence approach.  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a25dd7da-3647-4d10-b4f2-3d00c1888837/documents/bfc161cf-a1c8-401c-a115-6b30b34d4e24_db995f28-c0ff-41ab-89d7-c02e2e461934.html,,,,,, "6-fluoro-3-(piperidin-4-yl)-1,2-benzoxazole hydrochloride",84163-13-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a25dd7da-3647-4d10-b4f2-3d00c1888837/documents/bfc161cf-a1c8-401c-a115-6b30b34d4e24_db995f28-c0ff-41ab-89d7-c02e2e461934.html,,oral,LD50,> 50 mg/kg bw,adverse effect observed, "6H-dibenz[c,e][1,2]oxaphosphorin 6-oxide",35948-25-5,There was no evidence of significant general or specific tarfget organ toxicity in a 16 week dietary study in rats at doses up to 1094 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8be4ade9-ab52-4c8d-91fa-f66972c764c4/documents/IUC5-344c459b-263f-4f34-9aee-e5e4556545ee_60edc849-be4c-4b80-bb5b-6c06dff9bc4b.html,,,,,, "6H-dibenz[c,e][1,2]oxaphosphorin 6-oxide",35948-25-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8be4ade9-ab52-4c8d-91fa-f66972c764c4/documents/IUC5-344c459b-263f-4f34-9aee-e5e4556545ee_60edc849-be4c-4b80-bb5b-6c06dff9bc4b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "6H-dibenz[c,e][1,2]oxaphosphorin 6-oxide",35948-25-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8be4ade9-ab52-4c8d-91fa-f66972c764c4/documents/IUC5-02590055-e44b-40b3-afba-71ffbb851b9d_60edc849-be4c-4b80-bb5b-6c06dff9bc4b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 6-hydroxy-1H-pyrimidin-4-one,1193-24-4,"Oral: LD50 > 2000 mg/kg bw, male/female, rat, OECD 401, Ebert 1995 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39f61e79-e9d5-46ff-ba9d-d9edfaf806b1/documents/IUC5-103186bd-2adf-46c5-9fb3-d081c7d824e7_4910d650-ca0c-42ae-80ef-bcac485cdb60.html,,,,,, 6-hydroxy-1H-pyrimidin-4-one,1193-24-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39f61e79-e9d5-46ff-ba9d-d9edfaf806b1/documents/IUC5-103186bd-2adf-46c5-9fb3-d081c7d824e7_4910d650-ca0c-42ae-80ef-bcac485cdb60.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 6-hydroxy-2-naphthoic acid,16712-64-4,"Oral study was performed using the read-across substance, 3-hydroxy-2-naphthoic acid. Inhalation study was performed using the substance of record, 6-hydroxy-2-naphthoic acid. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be74227e-3d29-4ff3-8c64-59e4a1225f43/documents/IUC5-980bf9a8-2a5a-4c2b-af0a-0c9696e66ba9_1e176009-00b8-4f7b-a365-0621c3152d10.html,,,,,, 6-hydroxy-2-naphthoic acid,16712-64-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be74227e-3d29-4ff3-8c64-59e4a1225f43/documents/IUC5-980bf9a8-2a5a-4c2b-af0a-0c9696e66ba9_1e176009-00b8-4f7b-a365-0621c3152d10.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,12 mg/kg bw/day,,rat 6-hydroxy-2-naphthoic acid,16712-64-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be74227e-3d29-4ff3-8c64-59e4a1225f43/documents/IUC5-980bf9a8-2a5a-4c2b-af0a-0c9696e66ba9_1e176009-00b8-4f7b-a365-0621c3152d10.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,60 mg/m3,,rat 6-hydroxy-2-naphthoic acid,16712-64-4,"Two acute oral toxicity studies are available for the read-across substance, 3-hydroxy-2-naphthoic acid. The effect level for oral toxicity was using the most conservative (lowest LD50) value from the female animals of the Key Study. In the Acute Inhalation study of the substance of record, 6-hydroxy-2-naphthoic acid, no systemic effects were observed. The only observed effect was slight reversible irritation of the oral and respiratory mucous membranes consistent with mechanical irritation. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be74227e-3d29-4ff3-8c64-59e4a1225f43/documents/IUC5-2fe046ab-aa29-4a70-b554-cd324bc694d6_1e176009-00b8-4f7b-a365-0621c3152d10.html,,,,,, 6-hydroxy-2-naphthoic acid,16712-64-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be74227e-3d29-4ff3-8c64-59e4a1225f43/documents/IUC5-2fe046ab-aa29-4a70-b554-cd324bc694d6_1e176009-00b8-4f7b-a365-0621c3152d10.html,,oral,LD50,795 mg/kg bw,adverse effect observed, 6-methyl-2-oxoperhydropyrimidin-4-ylurea,1129-42-6,"Oral route: Oral sub-chronic toxicity Key, A4643, 90 days, rat, GLP, according to OECD 408 (2018): NOAEL ≥ 1000 mg/kg bw/day for males and females   Inhalation route: No data available.   Dermal route: No data available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b10e205-d0c9-4970-b0ed-277921f4faed/documents/IUC5-a54b28c3-18ab-45f8-bab3-f7cc13efb259_0ef27ce2-8d57-4dff-90e3-21a3a4e73034.html,,,,,, 6-methyl-2-oxoperhydropyrimidin-4-ylurea,1129-42-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b10e205-d0c9-4970-b0ed-277921f4faed/documents/IUC5-a54b28c3-18ab-45f8-bab3-f7cc13efb259_0ef27ce2-8d57-4dff-90e3-21a3a4e73034.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat 6-methyl-2-oxoperhydropyrimidin-4-ylurea,1129-42-6,"Oral (OECD 423), rat: LD50>2000 mg/kg bw (limit test) Inhalation: data waiving according to Column 2 of REACH Annex VIII Dermal (OECD 402, RA from CAS 6104-30-9), rat: LD50>2000 mg/kg bw (limit test) The study was conducted according to the appropriate OECD test guideline, and in compliance with GLP. The available information comprises adequate, reliable (Klimisch score 2) and consistent studies from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group, breakdown products, and similarities in PC/ECOTOX/TOX properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b10e205-d0c9-4970-b0ed-277921f4faed/documents/IUC5-8b4c2a66-0baa-44eb-981d-c274ef10d373_0ef27ce2-8d57-4dff-90e3-21a3a4e73034.html,,,,,, 6-methyl-2-oxoperhydropyrimidin-4-ylurea,1129-42-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b10e205-d0c9-4970-b0ed-277921f4faed/documents/IUC5-8b4c2a66-0baa-44eb-981d-c274ef10d373_0ef27ce2-8d57-4dff-90e3-21a3a4e73034.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 6-methyl-2-oxoperhydropyrimidin-4-ylurea,1129-42-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b10e205-d0c9-4970-b0ed-277921f4faed/documents/IUC5-8b4c2a66-0baa-44eb-981d-c274ef10d373_0ef27ce2-8d57-4dff-90e3-21a3a4e73034.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "6-methyl-3,4-dihydro-2H-1,4-benzoxazine",71472-57-6," OECD 422 Combined Repeated Dose Toxicity study with Reproduction/Developmental Toxicity screening test: It is concluded that the oral administration of 6 -methyl-3,4 -dihydro-2H-1,4 -benzoxazine to Han Wistar rats was generally tolerated in the adult animals but caused signs of decreased activity and partially closed eyelids at 150 mg/kg/day, which, due to the isolated, transient occurrence was considered non-adverse. In males, there was a 29% reduction of body weight gain at 150 mg/kg/day which was considered adverse. Due to the adverse effect on body weight gain in males at 150 mg/kg/day, the no observed adverse effect level (NOAEL) of the test substance for systemic toxicity was considered to be 50 mg/kg/day for males and 150 mg/kg/day for females. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f46fed51-67e7-4cc7-880c-81f7b2ac7d91/documents/f39b4518-4d71-44d0-9eef-c21a5b385aee_59fa06c3-4e3d-4516-acd2-8206799fc811.html,,,,,, "6-methyl-3,4-dihydro-2H-1,4-benzoxazine",71472-57-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f46fed51-67e7-4cc7-880c-81f7b2ac7d91/documents/f39b4518-4d71-44d0-9eef-c21a5b385aee_59fa06c3-4e3d-4516-acd2-8206799fc811.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "6-methyl-3,4-dihydro-2H-1,4-benzoxazine",71472-57-6," Acute Oral Toxicity (OECD 420): The acute median lethal oral dose (LD50) to rats of the test substance was demonstrated to be between 300 and 2000 mg/kg body weight. The substance is included in Category 4, according to the Globally Harmonised System (GHS). Acute Inhalation Toxicity (OECD 433): The LC50 (4 hour) of the test substance lies between 0.722 mg/L and 4.97 mg/L for male and female rats. The substance is classified as Category 4 according to the Globally Harmonised System (GHS; UNITED NATIONS). Acute Dermal Toxicity (OECD 402): The acute median lethal oral dose (LD50) to rats of the test substance was demonstrated to be greater than 2000 mg/kg body weight. The substance is included in Category 5/Unclassified, according to the Globally Harmonised System (GHS). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f46fed51-67e7-4cc7-880c-81f7b2ac7d91/documents/14345b75-a14f-4424-be81-50f4e9c2871a_59fa06c3-4e3d-4516-acd2-8206799fc811.html,,,,,, "6-methyl-3,4-dihydro-2H-1,4-benzoxazine",71472-57-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f46fed51-67e7-4cc7-880c-81f7b2ac7d91/documents/14345b75-a14f-4424-be81-50f4e9c2871a_59fa06c3-4e3d-4516-acd2-8206799fc811.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "6-methyl-3,4-dihydro-2H-1,4-benzoxazine",71472-57-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f46fed51-67e7-4cc7-880c-81f7b2ac7d91/documents/14345b75-a14f-4424-be81-50f4e9c2871a_59fa06c3-4e3d-4516-acd2-8206799fc811.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "6-methyl-3,4-dihydro-2H-1,4-benzoxazine",71472-57-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f46fed51-67e7-4cc7-880c-81f7b2ac7d91/documents/14345b75-a14f-4424-be81-50f4e9c2871a_59fa06c3-4e3d-4516-acd2-8206799fc811.html,,inhalation,LC50,0.722 mg/m3,adverse effect observed, "6-nonyl-1,3,5-triazine-2,4-diamine",5921-65-3, A NOAEL of 160 mg/kg bw/d for Caprinoguanamine was obtained for sub-acute toxicity from a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test according to OECD guideline 422. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7931271-a626-4993-8a9e-9fb56d4e9d08/documents/7f142be0-c074-4336-a87c-6ef1dc086206_7447e980-51c7-4c45-af4b-2aa5d8983bb3.html,,,,,, "6-nonyl-1,3,5-triazine-2,4-diamine",5921-65-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7931271-a626-4993-8a9e-9fb56d4e9d08/documents/7f142be0-c074-4336-a87c-6ef1dc086206_7447e980-51c7-4c45-af4b-2aa5d8983bb3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,160 mg/kg bw/day,,rat "6-nonyl-1,3,5-triazine-2,4-diamine",5921-65-3," Acute oral toxicity: LD50 > 10000 mg/kg bw, rat, similar to OECD Guideline 401, study performed before implementation of GLP Acute dermal toxicity: LD50 > 2800 mg/kg bw, rat/rabbit, similar to OECD Guideline 402, study performed before implementation of GLP Acute inhalation toxicity: not neccessary du to low acute systemic toxicity ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7931271-a626-4993-8a9e-9fb56d4e9d08/documents/IUC5-c239a785-198c-44c4-ba01-1894a938a3ae_7447e980-51c7-4c45-af4b-2aa5d8983bb3.html,,,,,, "6-nonyl-1,3,5-triazine-2,4-diamine",5921-65-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7931271-a626-4993-8a9e-9fb56d4e9d08/documents/IUC5-c239a785-198c-44c4-ba01-1894a938a3ae_7447e980-51c7-4c45-af4b-2aa5d8983bb3.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "6-nonyl-1,3,5-triazine-2,4-diamine",5921-65-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7931271-a626-4993-8a9e-9fb56d4e9d08/documents/IUC5-c239a785-198c-44c4-ba01-1894a938a3ae_7447e980-51c7-4c45-af4b-2aa5d8983bb3.html,,dermal,LD50,"2,800 mg/kg bw",no adverse effect observed, 6-tert-butyl-m-cresol,88-60-8,"An OECD combined repeat dose and reproduction toxicity screening test (OECD TG 422) was performed for 6-tert-butyl-m-cresol. SD (Crj:CD) rats received gavage doses of 0 (vehicle, corn oil), 2.5, 12.5 and 60 mg/kg/day. Males were dosed for 42 days and females were dosed from 14 days before maiting, throughout pregnancy until day 3 of lactation. No animal died in any group. No significant clinical sign was observed in any group. Suppression of body weight gain and decrease in food consumption were observed in females of the 60 mg/kg group, along with liver weight increase.. Histopathological examination revealed hypertrophy of centrilobular hepatocytes in males and females of the 60 mg/kg group. Whereas increase in the kidney weight was found in both sexes given 60 mg/kg, there were no adverse effects by histopathological examination. No significant effect was observed in hematology, urinalysis and blood biochemical parameters for males (these endpoints were not tested in females). The NOAEL for repeated dose toxicity is considered to be 12.5 mg/kg/day for both sexes ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ab1e46b-398d-46c1-908f-2d11bcf0e7d2/documents/IUC5-67797afc-3274-4537-af40-ac95c4f6157d_0f5cfe71-20e7-4dcd-974a-536ef1eca4a3.html,,,,,, 6-tert-butyl-m-cresol,88-60-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ab1e46b-398d-46c1-908f-2d11bcf0e7d2/documents/IUC5-67797afc-3274-4537-af40-ac95c4f6157d_0f5cfe71-20e7-4dcd-974a-536ef1eca4a3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,12.5 mg/kg bw/day,, 6-tert-butyl-m-cresol,88-60-8,"Acute toxicity of this substance is the range of oral LD50 value 130-800 mg/kg in rats and mice. Toxic signs were found at 800 mg/kg in males and 130 mg/kg or more in female rats. These were hypoactivity, a prone or lateral position and soiled fur. Bradypnea and Cheyne-Strokes' respiration in moribund animals of both sexes and hypothermia, clonic convulsion, ataxic gait and vocalisation in females were observed. Studies for acute inhalative and acute dermal toxicity are not available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ab1e46b-398d-46c1-908f-2d11bcf0e7d2/documents/IUC5-9f79306f-9f09-44a0-a2ee-d2c895f52e95_0f5cfe71-20e7-4dcd-974a-536ef1eca4a3.html,,,,,, 6-tert-butyl-m-cresol,88-60-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ab1e46b-398d-46c1-908f-2d11bcf0e7d2/documents/IUC5-9f79306f-9f09-44a0-a2ee-d2c895f52e95_0f5cfe71-20e7-4dcd-974a-536ef1eca4a3.html,,oral,LD50,130 mg/kg bw,, 7-(4-ethyl-1-methyloctyl)quinolin-8-ol,73545-11-6," One key study is available, the study was performed in accordance with a suitable guideline (OECD 423) and in accordance with GLP. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a05352b-c905-408d-a3f6-32395f25908a/documents/c72d1082-77ff-412c-9611-9bdac50c8505_30113aa0-a926-407b-9ac3-3400543a93bf.html,,,,,, "7,7-dimethyl-3-oxa-6-azaoctan-1-ol",87787-67-5,"Sub-acute dermal NOAEL = 100 mg/kg bw/d; OECD 410 (equivalent); Ward, 1983)OECD 422 (Screening for reproductive/developmental toxicity) NOAEL = 250 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3d49091-0618-49ba-94de-edc3f422bc81/documents/28aca99b-d73b-4baa-8b3d-35b5b00950f9_19a45a71-e2bc-45e1-93bf-af03d7c23629.html,,,,,, "7,7-dimethyl-3-oxa-6-azaoctan-1-ol",87787-67-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3d49091-0618-49ba-94de-edc3f422bc81/documents/28aca99b-d73b-4baa-8b3d-35b5b00950f9_19a45a71-e2bc-45e1-93bf-af03d7c23629.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "7,7-dimethyl-3-oxa-6-azaoctan-1-ol",87787-67-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3d49091-0618-49ba-94de-edc3f422bc81/documents/28aca99b-d73b-4baa-8b3d-35b5b00950f9_19a45a71-e2bc-45e1-93bf-af03d7c23629.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,,rabbit "7,7-dimethyl-3-oxa-6-azaoctan-1-ol",87787-67-5,"Acute oral toxicity, key study : Equivalent or similar to OECD Guideline 401 (Acute Oral Toxicity). The combined (male and female) acute rat oral LD50 was calculated to be 1467 mg/kg. Acute oral median lethal dose (NOAEL of <1000 mg/kg also estimated from study). Substance meets classification criteria for acute oral toxicity.Acute dermal toxicity, key study : Equivalent or similar to OECD Guideline 402 (Acute Dermal Toxicity). The acute dermal LD50 in the New Zealand White rabbit was calculated to be >3160mg/kg. Acute dermal median lethal dose (NOAEL of 2000 mg/kg estimated from study). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3d49091-0618-49ba-94de-edc3f422bc81/documents/45765640-5102-461b-97a9-3c092ea39bda_19a45a71-e2bc-45e1-93bf-af03d7c23629.html,,,,,, "7,7-dimethyl-3-oxa-6-azaoctan-1-ol",87787-67-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3d49091-0618-49ba-94de-edc3f422bc81/documents/45765640-5102-461b-97a9-3c092ea39bda_19a45a71-e2bc-45e1-93bf-af03d7c23629.html,,oral,LD50,"1,467 mg/kg bw",adverse effect observed, "7,7-dimethyl-3-oxa-6-azaoctan-1-ol",87787-67-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3d49091-0618-49ba-94de-edc3f422bc81/documents/45765640-5102-461b-97a9-3c092ea39bda_19a45a71-e2bc-45e1-93bf-af03d7c23629.html,,dermal,LD50,"3,160 mg/kg bw",no adverse effect observed, "7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl]azo]naphthalene-1,3,6-trisulphonic acid",35642-64-9," The repeated dose toxicity study was predicted using OECD QSAR toolbox version 3.4 (2017) with log kow as the primary descriptor and considering the four closest read across substances; to evaluate the toxic effects of administration of 7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6- chloro-1,3,5-triazin-2-yl)amino] phenyl]azo]naphthalene-1,3,6-trisulphonic acid (CAS No. 35642-64-9) in rats by the oral route in a 13 weeks of exposure. No adverse effects were observed. Therefore, the no-observed adverse effect level (NOAEL) of 7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl] azo]naphthalene- 1,3,6-trisulphonic acid (CAS No. 35642-64-9) was estimated to be 681.29 mg/kg bw/day (actual dose received). ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d544073-995a-4937-b6de-8ecdc57ab268/documents/b84a1f0f-9028-4e59-a709-9f3bc154f973_360f4343-6629-4bfa-bd98-39dd9ac67193.html,,,,,, "7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl]azo]naphthalene-1,3,6-trisulphonic acid",35642-64-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d544073-995a-4937-b6de-8ecdc57ab268/documents/b84a1f0f-9028-4e59-a709-9f3bc154f973_360f4343-6629-4bfa-bd98-39dd9ac67193.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,681.29 mg/kg bw/day,,rat "7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl]azo]naphthalene-1,3,6-trisulphonic acid",35642-64-9," Acute oral toxicity:  Acute oral toxicity dose (LD50) of 7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl]azo]naphthalene-1,3,6-trisulphonic acid (35642-64-9) was predicted based on OECD QSAR toolbox 3863 mg/kg bw and different studies available on structurally similar read across substances Disodium 5-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (CAS no.: 17804-49-8) 7460 mg/kg bw; Trisodium 7-[[4-chloro-6-[(4-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]methylamino]-4-hydroxy-3- [(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate (CAS No.-12237-01-3) 5000 mg/kg bw; Disodium 5-amino-4-hydroxy-3-(phenylazo) naphthalene-2, 7-disulphonate (CAS No. 3567-66-6) >2000 mg/kg bw; and Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. 15790-07-5)>2000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl]azo] naphthalene-1,3,6-trisulphonic acid cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  According to column 2 of REACH Annex VIII, the acute toxicity inhalation study need not be conducted because exposure of humans via inhalation route is not likely taking into account the low vapour pressure of the substance 7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl]azo]naphthalene-1,3,6-trisulphonic acid, which is reported as 3.72E-033 Pa. Also considering the particle size distribution of the substance, the majority of the particles were found to be in the size of 103.0 micrometer which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical 7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl]azo]naphthalene-1,3,6-trisulphonic acid is highly unlikely. Therefore this study is considered for waiver. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for 7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl]azo]naphthalene-1,3,6-trisulphonic acid (35642-64-9) was predicted based on OECD QSAR toolbox 7879 mg/kg bw and different studies available for the structurally similar read across substances Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (CAS No: 3734-67-6) >2000 mg/kg bw; Disodium 3-[(2,4-dimethyl-5-sulphonatophenyl)azo]-4-hydroxynaphthalene-1-sulphonate (4548-53-2) >2000 mg/kg bw; Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. 15790-07-5) >2000 mg/kg bw; and Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (3567-66-6) >2000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl]azo]naphthalene-1,3,6-trisulphonic acid cannot be classified for acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d544073-995a-4937-b6de-8ecdc57ab268/documents/ac161138-9a1b-4b78-9c45-f8af4a7f3d62_360f4343-6629-4bfa-bd98-39dd9ac67193.html,,,,,, "7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl]azo]naphthalene-1,3,6-trisulphonic acid",35642-64-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d544073-995a-4937-b6de-8ecdc57ab268/documents/ac161138-9a1b-4b78-9c45-f8af4a7f3d62_360f4343-6629-4bfa-bd98-39dd9ac67193.html,,oral,LD50,"3,863 mg/kg bw",no adverse effect observed, "7-[[2-[(aminocarbonyl)amino]-4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]phenyl]azo]naphthalene-1,3,6-trisulphonic acid",35642-64-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d544073-995a-4937-b6de-8ecdc57ab268/documents/ac161138-9a1b-4b78-9c45-f8af4a7f3d62_360f4343-6629-4bfa-bd98-39dd9ac67193.html,,dermal,LD50,"7,879 mg/kg bw",no adverse effect observed, "7-[[2-[(aminocarbonyl)amino]-4-[[4-chloro-6-[[4-[vinylsulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]phenyl]azo]naphthalene-1,3,6-trisulphonic acid, sodium salt",94158-80-2,"1,3,6-naphthalenetrisulfonic acid, 7-[[2 [(aminocarbonyl)amino]-4-[[4-chloro-6-[[4-(ethenylsulfonyl)phenyl]amino]-1,3,5-triazin-2-yl]amino]phenyl]azo]-, sodium salt is non toxic by oral route ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e67807b-cafc-4ff7-8563-968ef8bf8b6d/documents/IUC5-f894f785-95b8-4b9f-bef9-13372c7426c3_1861732c-5a06-4db6-8629-3c020317866a.html,,,,,, "7-[[2-[(aminocarbonyl)amino]-4-[[4-chloro-6-[[4-[vinylsulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]phenyl]azo]naphthalene-1,3,6-trisulphonic acid, sodium salt",94158-80-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e67807b-cafc-4ff7-8563-968ef8bf8b6d/documents/IUC5-f894f785-95b8-4b9f-bef9-13372c7426c3_1861732c-5a06-4db6-8629-3c020317866a.html,,oral,LD50,"6,610.222 mg/kg bw",no adverse effect observed, "7-[2-(2-hydroxymethylethoxy)methylethoxy]tetramethyl-3,6,8,11-tetraoxa-7-phosphatridecane-1,13-diol",36788-39-3,Guideline OECD 422 oral study in rats ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d2c02c9-bd23-4e08-a2c8-7892665f357d/documents/edabe187-68cd-4e06-8550-cec7143a723d_b32acca3-faf1-4478-9b70-875545e4e42a.html,,,,,, "7-[2-(2-hydroxymethylethoxy)methylethoxy]tetramethyl-3,6,8,11-tetraoxa-7-phosphatridecane-1,13-diol",36788-39-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d2c02c9-bd23-4e08-a2c8-7892665f357d/documents/edabe187-68cd-4e06-8550-cec7143a723d_b32acca3-faf1-4478-9b70-875545e4e42a.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat "7-[2-(2-hydroxymethylethoxy)methylethoxy]tetramethyl-3,6,8,11-tetraoxa-7-phosphatridecane-1,13-diol",36788-39-3,Both of the acute oral toxicity studies show no mortality at the limit dose of 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d2c02c9-bd23-4e08-a2c8-7892665f357d/documents/IUC5-5a64ac7e-d6b6-4a4f-ba0a-e02cf36a3e56_b32acca3-faf1-4478-9b70-875545e4e42a.html,,,,,, "7-[2-(2-hydroxymethylethoxy)methylethoxy]tetramethyl-3,6,8,11-tetraoxa-7-phosphatridecane-1,13-diol",36788-39-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d2c02c9-bd23-4e08-a2c8-7892665f357d/documents/IUC5-5a64ac7e-d6b6-4a4f-ba0a-e02cf36a3e56_b32acca3-faf1-4478-9b70-875545e4e42a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "7-[2-(2-hydroxymethylethoxy)methylethoxy]tetramethyl-3,6,8,11-tetraoxa-7-phosphatridecane-1,13-diol",36788-39-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d2c02c9-bd23-4e08-a2c8-7892665f357d/documents/IUC5-5a64ac7e-d6b6-4a4f-ba0a-e02cf36a3e56_b32acca3-faf1-4478-9b70-875545e4e42a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "7-acetamido-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2-sulphonic acid, sodium salt",85536-87-4," Several studies with either the test substance at a limit dose of 500 mg/kg bw/day administered daily for 14 days or structural analogues of the test substance administered daily for 28 or 30 days up to 1000 mg/kg bw/day resulted in no adverse effects due to the chromophoric structure of the dye. The only effects observed with the structural analogue SA01-Li was due to the adverse effects of the Li-cation. As the test substance is a Na-salt, the NOAEL for Reactive Orange 72/78 is considered to be 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1bb1313-626e-4b3f-bd11-908da530b155/documents/IUC5-a485c4c2-d658-4897-9487-8e681112edb3_ec2f9e42-14fc-4500-917b-516e02b73620.html,,,,,, "7-acetamido-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2-sulphonic acid, sodium salt",85536-87-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1bb1313-626e-4b3f-bd11-908da530b155/documents/IUC5-a485c4c2-d658-4897-9487-8e681112edb3_ec2f9e42-14fc-4500-917b-516e02b73620.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat "7-acetamido-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2-sulphonic acid, sodium salt",85536-87-4,"Reactive Orange 72/78 is practically non-toxic. The LD50 for oral administration is 8377 mg/kg body weight, the LD50 for dermal application withthe structural analogue 01 lies above 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1bb1313-626e-4b3f-bd11-908da530b155/documents/IUC5-6de4efb5-4e00-48eb-85db-543f615ce59c_ec2f9e42-14fc-4500-917b-516e02b73620.html,,,,,, "7-acetamido-4-hydroxy-3-[[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2-sulphonic acid, sodium salt",85536-87-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1bb1313-626e-4b3f-bd11-908da530b155/documents/IUC5-6de4efb5-4e00-48eb-85db-543f615ce59c_ec2f9e42-14fc-4500-917b-516e02b73620.html,,oral,LD50,"8,377 mg/kg bw",no adverse effect observed, "reaction mass of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4- hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2- sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)- 2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2- sulfonic acid, Na/K salt",214362-06-8,No toxicological relevant changes were seen in either the subacute 28-day study or the subchronic 90-day study in rats up to and including the highest dose level of 1000 mg/kg bw/day in rats. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab3b8519-10bd-4e92-8440-ec6b3ff4b31b/documents/13063413-2039-4a4e-97df-a88a3005a3b8_877e4ccf-07a8-43e0-842f-827ee5743d2c.html,,,,,, "reaction mass of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4- hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2- sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)- 2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2- sulfonic acid, Na/K salt",214362-06-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab3b8519-10bd-4e92-8440-ec6b3ff4b31b/documents/13063413-2039-4a4e-97df-a88a3005a3b8_877e4ccf-07a8-43e0-842f-827ee5743d2c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat "reaction mass of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4- hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2- sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)- 2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2- sulfonic acid, Na/K salt",214362-06-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab3b8519-10bd-4e92-8440-ec6b3ff4b31b/documents/13063413-2039-4a4e-97df-a88a3005a3b8_877e4ccf-07a8-43e0-842f-827ee5743d2c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"> 1,000 mg/kg bw/day",,rat "reaction mass of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4- hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2- sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)- 2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2- sulfonic acid, Na/K salt",214362-06-8,The substance is of low toxicity with oral and dermal LD50 in the rat of above 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab3b8519-10bd-4e92-8440-ec6b3ff4b31b/documents/6b9815a0-54e0-4e71-a8e2-fa0ef21e53a5_877e4ccf-07a8-43e0-842f-827ee5743d2c.html,,,,,, "reaction mass of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4- hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2- sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)- 2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2- sulfonic acid, Na/K salt",214362-06-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab3b8519-10bd-4e92-8440-ec6b3ff4b31b/documents/6b9815a0-54e0-4e71-a8e2-fa0ef21e53a5_877e4ccf-07a8-43e0-842f-827ee5743d2c.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "reaction mass of: 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4- hydroxynaphthalene-2-sulfonic acid, Na/K salt; 7-amino-3-[4-(2-sulfoxyethylsulfonyl)phenylazo]-4-hydroxy-8-[4-(2-sulfoxyethylsulfonyl)-2- sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-8-[4-(2-sulfoxyethylsulfonyl)-phenylazo]-4-hydroxy-3-[4-(2-sulfoxyethylsulfonyl)- 2-sulfophenylazo]naphthalene-2-sulfonic acid, Na/K salt; 7-amino-3,8-bis-[4-(2-sulfoxyethylsulfonyl)-2-sulfophenylazo]-4-hydroxynaphthalene-2- sulfonic acid, Na/K salt",214362-06-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab3b8519-10bd-4e92-8440-ec6b3ff4b31b/documents/6b9815a0-54e0-4e71-a8e2-fa0ef21e53a5_877e4ccf-07a8-43e0-842f-827ee5743d2c.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "7-amino-4-hydroxy-3-[[4-[(4-sulphophenyl)azo]phenyl]azo]naphthalene-2-sulphonic acid, compound with 2,2',2''-nitrilotriethanol (1:2)",64683-40-5," Repeated dose oral toxicity information is derived from a 28 day oral toxicity study ( OECD 422, GLP compliant) conducted in rats on an analogue substance. The oral administration of the substance to rats by gavage, at dose levels of 750, 300 and 30 mg/ kg bw/day, resulted in treatment-related changes at 750 and 300 mg/kg bw/day. Effects at 300 mg/kg bw/day were considered not to represent an adverse effect. Therefore a ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was considered to be 300 mg/kg bw/day. The NOAEL has been used to derive the relevant DNEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a239c93-5bc1-4704-81e4-3f62a6ede570/documents/3e7885e6-b32f-4a69-929b-de68815300cf_4bbc2950-778d-4aa8-b427-c3010caf39f2.html,,,,,, "7-amino-4-hydroxy-3-[[4-[(4-sulphophenyl)azo]phenyl]azo]naphthalene-2-sulphonic acid, compound with 2,2',2''-nitrilotriethanol (1:2)",64683-40-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a239c93-5bc1-4704-81e4-3f62a6ede570/documents/3e7885e6-b32f-4a69-929b-de68815300cf_4bbc2950-778d-4aa8-b427-c3010caf39f2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "7-amino-4-hydroxy-3-[[4-[(4-sulphophenyl)azo]phenyl]azo]naphthalene-2-sulphonic acid, compound with 2,2',2''-nitrilotriethanol (1:2)",64683-40-5," To assess the acute toxicity by oral route of the substance, an adequate study in the rat following oral administration has been conducted on a similar substance (read-across). Additionnally one supporting study done with a preparation of the substance (at a max. 35%) is available. Although the data with the preparation is not representative to assess the oral toxicity of the pure dye, it supports that the substance is not toxic by oral route. The dermal acute toxicity of the substance has been determined in an adequate study in the rat following dermal administration. No studies are available for inhalation. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a239c93-5bc1-4704-81e4-3f62a6ede570/documents/a868c2de-a66f-4519-af0c-9ec06858d2e3_4bbc2950-778d-4aa8-b427-c3010caf39f2.html,,,,,, "7-amino-4-hydroxy-3-[[4-[(4-sulphophenyl)azo]phenyl]azo]naphthalene-2-sulphonic acid, compound with 2,2',2''-nitrilotriethanol (1:2)",64683-40-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a239c93-5bc1-4704-81e4-3f62a6ede570/documents/a868c2de-a66f-4519-af0c-9ec06858d2e3_4bbc2950-778d-4aa8-b427-c3010caf39f2.html,,oral,LD50,"2,516 mg/kg bw",no adverse effect observed, "7-amino-4-hydroxy-3-[[4-[(4-sulphophenyl)azo]phenyl]azo]naphthalene-2-sulphonic acid, compound with 2,2',2''-nitrilotriethanol (1:2)",64683-40-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a239c93-5bc1-4704-81e4-3f62a6ede570/documents/a868c2de-a66f-4519-af0c-9ec06858d2e3_4bbc2950-778d-4aa8-b427-c3010caf39f2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 7-aminoheptanoic acid,929-17-9, Bibliography search DL50 Oral/Mouse: 9000 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/599098e0-be66-4526-a385-6f04697fb5e8/documents/f762544b-a01a-48c9-bf8b-f930c24230af_24b6b345-7c9f-458a-9cb8-dc67a059a66c.html,,,,,, "7-anilino-4-hydroxy-3-[[6-methoxy-4-[(6-sulpho-2,4-xylyl)azo]-m-tolyl]azo]naphthalene-2-sulphonic acid, sodium salt, compound with 2,2',2''-nitrilotriethanol",94213-53-3, Repeated oral dose toxicity NOEAL = 15 mg/kg bw LOAEL = 40 mg/kg bw ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/343dd5b2-fa6d-4401-b0a3-42b162500188/documents/10636d71-21be-4742-906a-b58295c29ec3_ee7c5d27-af2a-4c63-8515-325c4688488a.html,,,,,, "7-anilino-4-hydroxy-3-[[6-methoxy-4-[(6-sulpho-2,4-xylyl)azo]-m-tolyl]azo]naphthalene-2-sulphonic acid, sodium salt, compound with 2,2',2''-nitrilotriethanol",94213-53-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/343dd5b2-fa6d-4401-b0a3-42b162500188/documents/10636d71-21be-4742-906a-b58295c29ec3_ee7c5d27-af2a-4c63-8515-325c4688488a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "7-anilino-4-hydroxy-3-[[6-methoxy-4-[(6-sulpho-2,4-xylyl)azo]-m-tolyl]azo]naphthalene-2-sulphonic acid, sodium salt, compound with 2,2',2''-nitrilotriethanol",94213-53-3, Acute Oral Toxicity LD50 between 300 and 2000 mg/kg bw Acute Dermal Toxicity LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/343dd5b2-fa6d-4401-b0a3-42b162500188/documents/0a0b8d01-d92f-4773-981f-9fede2f116fa_ee7c5d27-af2a-4c63-8515-325c4688488a.html,,,,,, "7-anilino-4-hydroxy-3-[[6-methoxy-4-[(6-sulpho-2,4-xylyl)azo]-m-tolyl]azo]naphthalene-2-sulphonic acid, sodium salt, compound with 2,2',2''-nitrilotriethanol",94213-53-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/343dd5b2-fa6d-4401-b0a3-42b162500188/documents/0a0b8d01-d92f-4773-981f-9fede2f116fa_ee7c5d27-af2a-4c63-8515-325c4688488a.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "7-anilino-4-hydroxy-3-[[6-methoxy-4-[(6-sulpho-2,4-xylyl)azo]-m-tolyl]azo]naphthalene-2-sulphonic acid, sodium salt, compound with 2,2',2''-nitrilotriethanol",94213-53-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/343dd5b2-fa6d-4401-b0a3-42b162500188/documents/0a0b8d01-d92f-4773-981f-9fede2f116fa_ee7c5d27-af2a-4c63-8515-325c4688488a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 7-anilino-4-hydroxynaphthalene-2-sulphonic acid,119-40-4, 7-anilino-4-hydroxynaphthalene-2-sulphonic acid  is likely to be non hazardous by oral route of exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e06859c-e65f-420c-8c0f-c26b1c76da73/documents/IUC5-bb6e1426-baa2-4b21-a06f-b335d5723fc3_a6b8c6fd-12e9-48b6-97f6-5cbc88a63d46.html,,,,,, 7-anilino-4-hydroxynaphthalene-2-sulphonic acid,119-40-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e06859c-e65f-420c-8c0f-c26b1c76da73/documents/IUC5-bb6e1426-baa2-4b21-a06f-b335d5723fc3_a6b8c6fd-12e9-48b6-97f6-5cbc88a63d46.html,,oral,LD50,"3,513.8 mg/kg bw",no adverse effect observed, "7-azatridecane-1,13-diamine",143-23-7," No repeated dose toxicity data are available for the registration substance. However adequate and reliable studies performed with a surrogate substance (multi-constituent substance containing high levels of this registration substance) are at hand. In a subchronic toxicity study the surrogate susbtance was administered orally to rats. Recalculating the effect level to the submission substance led to a NOAEL of 13 mg/kg bw. However, as explained below, the only effects seen in the study were in the upper and lower respiratory tract. Based on this study the oral toxicity of the submission substance appears to be low and the effects observed in rats seem to be consecutive to the inhalation route (false route perhaps du to the viscosity of the substance). In a subchronic inhalation toxicity study rats were exposed to aerosol of the test material. A No observed adverse effect level could not be determined as in all concentration tested effects on the respiratory tract were observed (organs were affected; the nasal passages, trachea and lungs). The incidence and severity of the lesions was increased as a function of higher exposure levels. The LOAEC of this study is 10 mg/m³. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7949c6b1-b2e5-4351-9e3e-c9ba4119045b/documents/76dac710-43e3-438b-ba0e-15d5c64ae2b1_a926f2ef-b8c5-444d-9186-b4624d452f2c.html,,,,,, "7-azatridecane-1,13-diamine",143-23-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7949c6b1-b2e5-4351-9e3e-c9ba4119045b/documents/76dac710-43e3-438b-ba0e-15d5c64ae2b1_a926f2ef-b8c5-444d-9186-b4624d452f2c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,13 mg/kg bw/day,,rat "7-azatridecane-1,13-diamine",143-23-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7949c6b1-b2e5-4351-9e3e-c9ba4119045b/documents/76dac710-43e3-438b-ba0e-15d5c64ae2b1_a926f2ef-b8c5-444d-9186-b4624d452f2c.html,Repeated dose toxicity – local effects,inhalation,LOAEC,10 mg/m3,adverse effect observed,rat "7-azatridecane-1,13-diamine",143-23-7, In an oral acute toxicity study the LD50 identified in rats was 1170 mg/kg bw. In a dermal acute toxicity study the LD50 identified in rats was approx. 1200 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7949c6b1-b2e5-4351-9e3e-c9ba4119045b/documents/09f5916d-c286-4e45-8969-24030ff06853_a926f2ef-b8c5-444d-9186-b4624d452f2c.html,,,,,, "7-azatridecane-1,13-diamine",143-23-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7949c6b1-b2e5-4351-9e3e-c9ba4119045b/documents/09f5916d-c286-4e45-8969-24030ff06853_a926f2ef-b8c5-444d-9186-b4624d452f2c.html,,oral,LD50,"1,170 mg/kg bw",adverse effect observed, "7-azatridecane-1,13-diamine",143-23-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7949c6b1-b2e5-4351-9e3e-c9ba4119045b/documents/09f5916d-c286-4e45-8969-24030ff06853_a926f2ef-b8c5-444d-9186-b4624d452f2c.html,,dermal,LD50,"1,200 mg/kg bw",adverse effect observed, 7-benzamido-4-hydroxynaphthalene-2-sulphonic acid,132-87-6, LD50 was estimated to be 2541 mg/kg bw when Wistar female rats were orally exposed with 7-(benzoylamino)-4-hydroxynaphthalene-2-sulfonic acid.  ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e76f742-cc94-431c-8423-108596ce62e0/documents/5cb3cd43-1334-4622-ae21-e015998afc64_8445adc4-074a-4798-8d09-6993d0324e59.html,,,,,, 7-benzamido-4-hydroxynaphthalene-2-sulphonic acid,132-87-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e76f742-cc94-431c-8423-108596ce62e0/documents/5cb3cd43-1334-4622-ae21-e015998afc64_8445adc4-074a-4798-8d09-6993d0324e59.html,,oral,LD50,"2,541 mg/kg bw",no adverse effect observed, "7-Benzothiazolesulfonic acid, 2-[4-[[4-[[3-[[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]azo]-4-sulfophenyl]amino]-6-chloro-1,3,5-triazin-2-yl]amino]phenyl]-6-methyl-, disodium salt",85665-95-8, Oral: no study available. Inhalation: no study available. Dermal: The test item was used in an 28-d repeated dose toxicity study with male and female rats according to OECD 410. The no adverse effect level NOAEL in male rats was determined at 1000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7aca8ce7-31e0-4e86-9ade-6b725d9ab150/documents/0469e7c2-bef6-41ae-89f1-e060e4303df7_9d1e22bd-39f2-4772-8902-e2a822ba86e9.html,,,,,, "7-Benzothiazolesulfonic acid, 2-[4-[[4-[[3-[[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]azo]-4-sulfophenyl]amino]-6-chloro-1,3,5-triazin-2-yl]amino]phenyl]-6-methyl-, disodium salt",85665-95-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7aca8ce7-31e0-4e86-9ade-6b725d9ab150/documents/0469e7c2-bef6-41ae-89f1-e060e4303df7_9d1e22bd-39f2-4772-8902-e2a822ba86e9.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "7-Benzothiazolesulfonic acid, 2-[4-[[4-[[3-[[5-(aminocarbonyl)-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridinyl]azo]-4-sulfophenyl]amino]-6-chloro-1,3,5-triazin-2-yl]amino]phenyl]-6-methyl-, disodium salt",85665-95-8," Oral: The LD50 (oral, gavage) in male/female rats was determined >5000 mg/kg bw. The substance is not classifiable according to CLP criteria. Dermal: The LD50 (dermal, occlusive) in male/female rats was determined >2000 mg/kg bw. The substance is not classifiable according to CLP criteria. Inhalation: no study available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7aca8ce7-31e0-4e86-9ade-6b725d9ab150/documents/ba5eb61b-3573-4e84-8a02-89a6f6bc21b8_9d1e22bd-39f2-4772-8902-e2a822ba86e9.html,,,,,, "7-Cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide",1211441-98-3," Repeated dose toxicity study; Test duration: 15 weeks with 4 weeks recovery The dose regimen was: 3 weeks on / 1 week off (like clinical) Rats M: 25, 75, 150 mg/kg; F: 50, 150, 300 mg/kg Route of administration: Oral Effects ≥ 25 mg/kg/day M: hematology changes consistent with decreased hematopoiesis, decrease in the thymus weights were observed in males ≥ 75 mg/kg/day M: kidney, testes/epididymis, hematopoietic system (thymus, lymph nodes, bone marrow) 150 mg/kg/day M: lung, liver, ≥ 150 mg/kg/day F: lymph nodes Based on the severity of findings in the testes of males given ≥75 mg/kg/day and in the lung of males given 150 mg/kg/day, these observations were considered adverse. NOAEL M: 25 mg/kg/day; F: 300 mg/kg/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b57bd009-bff0-4b61-ab52-2a1e9d4eda97/documents/e94c6e09-6600-4911-8228-078379e7c198_a63c6727-097d-461d-9b17-33e003f9fedc.html,,,,,, "7-Cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide",1211441-98-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b57bd009-bff0-4b61-ab52-2a1e9d4eda97/documents/e94c6e09-6600-4911-8228-078379e7c198_a63c6727-097d-461d-9b17-33e003f9fedc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "7-Cyclopentyl-N,N-dimethyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7H-pyrrolo[2,3-d]pyrimidine-6-carboxamide",1211441-98-3," Compared with the Cmax and AUC(0-72h) values at 100 mg/kg, the Cmax and AUC(0-72h) values measured in the female dog at 150 mg/kg were slightly lower. This was mostly due to vomiting with dose formulation resulting in lower uptake of the test item. In conclusion, oral administration of single dosages of LEE011 at 25, 50, 100 and 150 mg/kg to one male and one female Beagle dogs was well tolerated up to 25 (males) and 50 mg/kg (females). Based on the slight to severe decreases in food consumption at ≥ 25 mg/kg and the toxicokinetic parameters, a no-observable-effect-level (NOEL) was not established in this study, whereas a single dose of 100 mg/kg LEE011 was considered to be the maximum tolerable dose (MTD) in view of the pronounced emesis at ≥ 100 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b57bd009-bff0-4b61-ab52-2a1e9d4eda97/documents/659fad17-e81b-467d-b73b-bcb9df4ded6f_a63c6727-097d-461d-9b17-33e003f9fedc.html,,,,,, "7-ethoxy-4,6-difluoro-dibenzothiophen-3-ol",1820028-80-5, The test material was investigated for acute oral toxicity using in vivo methods. The GLP compliant study was fully compliant with OECD TG 423. The follwing results have been obtained: Acute toxicity: oral: OECD 423: LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f427f533-e28a-4558-9dc7-e76d17d1eafa/documents/4478ea14-a66f-4730-abd1-414ad06c2f06_a4a4f403-456d-4093-a9c5-f1ade553968f.html,,,,,, "7-ethoxy-4,6-difluoro-dibenzothiophen-3-ol",1820028-80-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f427f533-e28a-4558-9dc7-e76d17d1eafa/documents/4478ea14-a66f-4730-abd1-414ad06c2f06_a4a4f403-456d-4093-a9c5-f1ade553968f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "7-Isopropyl-2H,4H-1,5-benzodioxepin-3-one",950919-28-5,"Repeated dose 28-day Oral toxicity study in rats: NOAEL = 300 mg/kg bw/day (OECD 407, GLP, rel. 1) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4928e5e4-0046-4f3e-a3ec-c9ea748923fc/documents/IUC5-33a13737-d452-49fa-87f8-a3326a0f5cf4_30fd1e6e-d51e-445e-b0d1-1f4d65df223d.html,,,,,, "7-Isopropyl-2H,4H-1,5-benzodioxepin-3-one",950919-28-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4928e5e4-0046-4f3e-a3ec-c9ea748923fc/documents/IUC5-33a13737-d452-49fa-87f8-a3326a0f5cf4_30fd1e6e-d51e-445e-b0d1-1f4d65df223d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "7-Isopropyl-2H,4H-1,5-benzodioxepin-3-one",950919-28-5,"Acute toxicity: oral: 300 < Rat LD50 (female) < 2000 mg/kg bw (OECD 420, GLP, K, rel. 1)Acute toxicity: dermal: Rat LD50 > 2000 mg/kg bw (OECD 402, GLP, K, rel. 1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4928e5e4-0046-4f3e-a3ec-c9ea748923fc/documents/IUC5-f23493c6-7340-45ed-858c-1c858251f1c4_30fd1e6e-d51e-445e-b0d1-1f4d65df223d.html,,,,,, "7-Isopropyl-2H,4H-1,5-benzodioxepin-3-one",950919-28-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4928e5e4-0046-4f3e-a3ec-c9ea748923fc/documents/IUC5-f23493c6-7340-45ed-858c-1c858251f1c4_30fd1e6e-d51e-445e-b0d1-1f4d65df223d.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "7-methoxy-1,2,3,4-tetrahydronaphthalen-2-one",4133-34-0," Acute Oral Toxicity: The LD50 was estimated to be 3340.62 mg/kg bw, when rats were orally exposed with 7-methoxy-1,2,3,4-tetrahydronaphthalen-2-one (4133-34-0) . Acute Dermal Toxicity: The LD50 value was estimated to be 4498.41 mg/kg bw, when male and female HanIbm: WIST (SPF) rats were exposed semiocclusively with 7-methoxy-1,2,3,4-tetrahydronaphthalen-2-one (4133-34-0) by dermal application for 24 hours. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/475f9d16-f80a-48bb-bd1a-bb590fe52641/documents/5aa78213-a317-4192-b0f0-a97dd199126c_e110f8d3-8f72-45b6-8f4c-849f51790fc0.html,,,,,, "7-methoxy-1,2,3,4-tetrahydronaphthalen-2-one",4133-34-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/475f9d16-f80a-48bb-bd1a-bb590fe52641/documents/5aa78213-a317-4192-b0f0-a97dd199126c_e110f8d3-8f72-45b6-8f4c-849f51790fc0.html,,oral,LD50,"3,340.62 mg/kg bw",no adverse effect observed, "7-methoxy-1,2,3,4-tetrahydronaphthalen-2-one",4133-34-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/475f9d16-f80a-48bb-bd1a-bb590fe52641/documents/5aa78213-a317-4192-b0f0-a97dd199126c_e110f8d3-8f72-45b6-8f4c-849f51790fc0.html,,dermal,LD50,"4,498.41 mg/kg bw",no adverse effect observed, 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate,2386-87-0,"Two repeated dose oral toxicity studies are available, one of which is a 90 day toxicity study and the other is a 14 day toxicity study. The studies were conducted according to OECD guidelines 408 and 407, respectively. The studies used male and female rats as the test species, specifically Crl:CD® (SD)IGS BR species. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fed34105-6f7b-4404-961b-f276d76532e6/documents/IUC5-34fac139-ba4c-4d1b-8d73-08ee0faa4e2b_b4b0919a-f78d-4d67-ae4e-19bfe3484876.html,,,,,, 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate,2386-87-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fed34105-6f7b-4404-961b-f276d76532e6/documents/IUC5-34fac139-ba4c-4d1b-8d73-08ee0faa4e2b_b4b0919a-f78d-4d67-ae4e-19bfe3484876.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate,2386-87-0,"Two acute oral toxicity study reports are available. The studies were conducted using male and female Crl:CD(SD)IGS BR and Sprague Dawley rats. One of the studies conformed to the OECD guideline 401 (Acute Oral Toxicity). In both instances, Celloxide 2021 was not classified as the LD50 values were at least 5000mg/kg. An acute inhalation study is available. The rat was the test species. Based on the study results the test substance does not require classification. In an acute dermal toxicity study conforming to OECD Guideline 402, rats were used as the test species. The study indicated that the test substance should not be classified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fed34105-6f7b-4404-961b-f276d76532e6/documents/IUC5-ddeeadad-b0eb-4729-a09b-33786ef2ed8f_b4b0919a-f78d-4d67-ae4e-19bfe3484876.html,,,,,, 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate,2386-87-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fed34105-6f7b-4404-961b-f276d76532e6/documents/IUC5-ddeeadad-b0eb-4729-a09b-33786ef2ed8f_b4b0919a-f78d-4d67-ae4e-19bfe3484876.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate,2386-87-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fed34105-6f7b-4404-961b-f276d76532e6/documents/IUC5-ddeeadad-b0eb-4729-a09b-33786ef2ed8f_b4b0919a-f78d-4d67-ae4e-19bfe3484876.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 7-oxabicyclo[4.1.0]hept-3-ylmethyl 7-oxabicyclo[4.1.0]heptane-3-carboxylate,2386-87-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fed34105-6f7b-4404-961b-f276d76532e6/documents/IUC5-ddeeadad-b0eb-4729-a09b-33786ef2ed8f_b4b0919a-f78d-4d67-ae4e-19bfe3484876.html,,inhalation,discriminating conc.,"5,000 mg/m3",no adverse effect observed, "8,8-dioctyl-1,4-dioxa-7,9-dithia-8-stannacycloundecane-5,11-dione",69226-44-4," Read-across data: DOTI (CAS 26401 -97 -8) -Rat 13 week oral study (1970) Under the conditions of the study the 13 week oral no adverse effect level was found to be 150 ppm in male and female rats, the highest dose tested. -Dog 14 week oral study (1970) Under the conditions of the study the sub-chronic repeated dose oral no observed adverse effect level was 150 ppm in male and female beagle dogs, the highest dose level tested. -Oral 30 days rat and dog (1963) Under the conditions of this study the NOAEL of the test material to male rats and dogs was 25 and 75 ppm, respectively. Read-across data - Rat 13 week oral study (mixture DOTE:MOTE:TOTE, 97: 0.3: 2.7) (CAS No 15571 -58 -1, CAS 27107-89-7, CAS 61912-55-8) The NOAEL was determined to be 10 ppm (equivalent to 0.5 mg/kg bw/day) and the LOAEL was determined to be 25 ppm (equivalent to 1.3 mg/kg bw/day) based on reduced thymus weight. Read-across data - Rat 13 week oral study (mixture DOTE: MOTE. 70:30) (CAS No 15571-58-1 and CAS 27107-89-7) The no effect level for the test material was determined to be 25 ppm (calculated as 1.25 mg/kg/day, based on a food factor of 0.05) based on reduced absolute and relative thymus gland weights. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/632a78a4-4c7d-42b3-a3e8-da577e5195c8/documents/d789b035-9bba-4e5e-a3a3-ec97646c35a6_1d9f6390-9ad0-4703-ab17-9438145363cf.html,,,,,, "8,8-dioctyl-1,4-dioxa-7,9-dithia-8-stannacycloundecane-5,11-dione",69226-44-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/632a78a4-4c7d-42b3-a3e8-da577e5195c8/documents/d789b035-9bba-4e5e-a3a3-ec97646c35a6_1d9f6390-9ad0-4703-ab17-9438145363cf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.5 mg/kg bw/day,,rat "8,8-dioctyl-1,4-dioxa-7,9-dithia-8-stannacycloundecane-5,11-dione",69226-44-4," ORAL TOXICITY Read-across to structurally similar substance (DOTI) (CAS No 26401 -97 -8) Auletta (1984) Under the conditions of this key study the acute oral LD50 of the test material is 1800 mg/kg with 95 % confidence interval of 1040 to 2560 mg/kg. INHALATION TOXICITY Read-across to structurally similar substance (DOTI) (CAS No 26401 -97 -8) Under the conditions of the study following a 7 hour treatment to a mixture of 80% registered substance (DOTI) and 20% MOTI (CAS 26401-86-5), no mortality occurred. In some animals, a temporary conjunctivitis was observed during the post-treatment period. DERMAL TOXICITY Read-across to structurally similar substance (DOTE) (CAS No 15571 -58 -1) Under the conditions of this study, the acute dermal toxicity LD50 (rat) of the test material was > 2000 mg/kg bw(both sexes). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/632a78a4-4c7d-42b3-a3e8-da577e5195c8/documents/950e3998-cc63-40a8-af8c-6bbcbd1d73db_1d9f6390-9ad0-4703-ab17-9438145363cf.html,,,,,, "8,8-dioctyl-1,4-dioxa-7,9-dithia-8-stannacycloundecane-5,11-dione",69226-44-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/632a78a4-4c7d-42b3-a3e8-da577e5195c8/documents/950e3998-cc63-40a8-af8c-6bbcbd1d73db_1d9f6390-9ad0-4703-ab17-9438145363cf.html,,oral,LD50,"1,800 mg/kg bw",adverse effect observed, "8,8-dioctyl-1,4-dioxa-7,9-dithia-8-stannacycloundecane-5,11-dione",69226-44-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/632a78a4-4c7d-42b3-a3e8-da577e5195c8/documents/950e3998-cc63-40a8-af8c-6bbcbd1d73db_1d9f6390-9ad0-4703-ab17-9438145363cf.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "8,9,10,11-tetrachloro-12H-phthaloperin-12-one",20749-68-2,"Repeated dose toxicity: via oral route: NOAEL > 1000 mg/kg bw/day (OECD 407, GLP, Key, Rel.1) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b158429e-1d2e-467c-90b8-460f32c51ec0/documents/954edc34-7d1a-4f05-bd2c-891e86d6d3a3_7ca60337-4978-4767-ab9b-9f5847b03ec9.html,,,,,, "8,9,10,11-tetrachloro-12H-phthaloperin-12-one",20749-68-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b158429e-1d2e-467c-90b8-460f32c51ec0/documents/954edc34-7d1a-4f05-bd2c-891e86d6d3a3_7ca60337-4978-4767-ab9b-9f5847b03ec9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"> 1,000 mg/kg bw/day",,rat "8,9,10,11-tetrachloro-12H-phthaloperin-12-one",20749-68-2,"Acute toxicity via Oral route: Combined LD50 > 5000 mg/kg bw (OECD 401, GLP, K, Rel.2). Acute toxicity via Dermal route: No study available Acute toxicity via Inhalation route: Combined LC50 > 2868 mg/m3 (OECD 403, GLP, K, Rel.1). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b158429e-1d2e-467c-90b8-460f32c51ec0/documents/be80b780-8835-42ec-b038-df20804fee1f_7ca60337-4978-4767-ab9b-9f5847b03ec9.html,,,,,, "8,9,10,11-tetrachloro-12H-phthaloperin-12-one",20749-68-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b158429e-1d2e-467c-90b8-460f32c51ec0/documents/be80b780-8835-42ec-b038-df20804fee1f_7ca60337-4978-4767-ab9b-9f5847b03ec9.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "8,9,10,11-tetrachloro-12H-phthaloperin-12-one",20749-68-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b158429e-1d2e-467c-90b8-460f32c51ec0/documents/be80b780-8835-42ec-b038-df20804fee1f_7ca60337-4978-4767-ab9b-9f5847b03ec9.html,,inhalation,LC50,"> 2,868 mg/m3",no adverse effect observed, "8,9,10-trinorborn-2-ene",498-66-8,"There were no relevant adverse effects in male and female rats receiving norbornene (125, 250, 500 mg/kg bw and day) by oral gavage in a combined repeated dose/reproduction toxicity study (OECD 422, GLP). The NOAEL for local and systemic toxicity was therefore 500 mg/kg bw and day. A target organ was not identified. An inhalative 90d (600, 2000 and 5000 mg/m³) showed increased organ weights (ovaries) leading to an NOAEL for systemic toxicity of 2020 mg/m³.corresponding to 582 mg/kg bw/day. Inhalative irritation observed was considered not toxicollogically significant. Hyaline droplet formation observed in male rats both in the 28d and 90d study was identifed immunohistochemically as alpha-2µ-globulin nephropathy not significant to human. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5cb1df16-5743-42d7-ae88-96b3332dc997/documents/IUC5-0656a3c2-6cab-47a3-a867-790904b0ac1d_8d25b9ea-fe74-4042-9e02-382d09ba0c34.html,,,,,, "8,9,10-trinorborn-2-ene",498-66-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5cb1df16-5743-42d7-ae88-96b3332dc997/documents/IUC5-0656a3c2-6cab-47a3-a867-790904b0ac1d_8d25b9ea-fe74-4042-9e02-382d09ba0c34.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "8,9,10-trinorborn-2-ene",498-66-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5cb1df16-5743-42d7-ae88-96b3332dc997/documents/IUC5-0656a3c2-6cab-47a3-a867-790904b0ac1d_8d25b9ea-fe74-4042-9e02-382d09ba0c34.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"2,020 mg/m3",,rat "8,9,10-trinorborn-2-ene",498-66-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5cb1df16-5743-42d7-ae88-96b3332dc997/documents/IUC5-0656a3c2-6cab-47a3-a867-790904b0ac1d_8d25b9ea-fe74-4042-9e02-382d09ba0c34.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"4,980 mg/m3",adverse effect observed,rat "8,9,10-trinorborn-2-ene",498-66-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cb1df16-5743-42d7-ae88-96b3332dc997/documents/IUC5-a348a4e9-0ad8-493b-855a-dba43c2a3df5_8d25b9ea-fe74-4042-9e02-382d09ba0c34.html,,oral,LD50,"9,577 mg/kg bw",, "8,9,10-trinorborn-2-ene",498-66-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cb1df16-5743-42d7-ae88-96b3332dc997/documents/IUC5-a348a4e9-0ad8-493b-855a-dba43c2a3df5_8d25b9ea-fe74-4042-9e02-382d09ba0c34.html,,dermal,LD50,"4,353 mg/kg bw",, "8,9,10-trinorborn-2-ene",498-66-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cb1df16-5743-42d7-ae88-96b3332dc997/documents/IUC5-a348a4e9-0ad8-493b-855a-dba43c2a3df5_8d25b9ea-fe74-4042-9e02-382d09ba0c34.html,,inhalation,LC50,"26,590 mg/m3",, 9-(2‘-Bromo-biphenyl-2-y)-9H-fluoren-9-ol,1603849-28-0, The test material was investigated for acute oral toxicity using in vivo methods. The GLP compliant study was fully compliant with OECD TG 423. The follwing results have been obtained: Acute toxicity: oral: OECD 423: LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5250ca58-a454-4e80-90e3-0f1e0702fbae/documents/2199a7f9-bc01-4ee1-bd07-3d47a6edfaf4_d954c9ca-6644-49ce-aa1b-d20ad5c5ecf5.html,,,,,, 9-(2‘-Bromo-biphenyl-2-y)-9H-fluoren-9-ol,1603849-28-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5250ca58-a454-4e80-90e3-0f1e0702fbae/documents/2199a7f9-bc01-4ee1-bd07-3d47a6edfaf4_d954c9ca-6644-49ce-aa1b-d20ad5c5ecf5.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium acetate",64381-99-3," Acute oral toxicity: The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is >5000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7775c460-ed72-4dc3-99b8-c77d0995acc1/documents/197a6d4a-bf38-4b7c-950a-a3a00549423b_8298fed8-598b-47a8-b05b-12415d1d2d02.html,,,,,, "9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium acetate",64381-99-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7775c460-ed72-4dc3-99b8-c77d0995acc1/documents/197a6d4a-bf38-4b7c-950a-a3a00549423b_8298fed8-598b-47a8-b05b-12415d1d2d02.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxy-N-3-(isopropoxypropyl)benzenesulphonamidato(2-)]cobaltate(1-)",71566-55-7, The acute oral LD50 was determined to be > 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b240372-a92a-4fa3-ab75-dae7f1076cfd/documents/291d147f-7759-4666-9a93-e3d2bae9dcd9_229e85d7-a050-4788-aaf5-766e000e6956.html,,,,,, "9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxy-N-3-(isopropoxypropyl)benzenesulphonamidato(2-)]cobaltate(1-)",71566-55-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b240372-a92a-4fa3-ab75-dae7f1076cfd/documents/291d147f-7759-4666-9a93-e3d2bae9dcd9_229e85d7-a050-4788-aaf5-766e000e6956.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,4-bis((2-ethylhexyl)amino)-5,8-dihydroxyanthracene-9,10-dione",295800-70-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0566a2b-1c8c-4d14-8a4e-a54d3113967c/documents/IUC5-c0bfb91a-15c4-4029-bc44-5036ce320bd7_13067b46-c874-4e1f-9b47-72afb34c1966.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,4-bis((2-ethylhexyl)amino)-5,8-dihydroxyanthracene-9,10-dione",295800-70-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0566a2b-1c8c-4d14-8a4e-a54d3113967c/documents/IUC5-c0bfb91a-15c4-4029-bc44-5036ce320bd7_13067b46-c874-4e1f-9b47-72afb34c1966.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "9,10-Anthracenedione, 1,4-diamino-, N,N'-bis(4-C7-17-branched alkylphenyl) derivs.",97862-23-2,"Repeated dose oral toxicity: In a study, the test chemical has been investigated for repeated dose toxicity to a greater or lesser extent. Study based on in vivo experiments in rodents, i.e. most commonly in rats for the test chemical are summarized below:   In a repeated dose toxicity study, Sprague-Dawley male and female rats were treated with the test chemical in the concentration of 0, 250, 500 and 1000 mg/kg bw orally by gavage for 28 days. All the male and female animals from control and different dose groups up to 1000 mg/kg survived throughout the dosing period of 28 days and the recovery period of 14 days. Male and female animals from control and different dose groups exhibited normal body weight gain at the end of the dosing period of 28 days and the recovery period of 14 days. Feed intake of animals from control and different dose groups was found to be comparable throughout the dosing period of 28 days and the recovery period of 14 days. Ophthalmoscopic examination, conducted prior to and at the end of dosing period on animals from control and different dose groups did not reveal any abnormality. Test item coloured faeces were observed in male and female animals from different dose groups during the dosing period of 28 days and the recovery period of 14 days. Detailed clinical observations conducted at weekly interval (upto 6th week) did not reveal any abnormality in all male and female animals from control and different dose groups during the dosing period of 28 days and the recovery period of 14 days. Similarly, Towards the end of the exposure period in week 4, functional observation battery such as sensory reactivity to stimuli of different types (e.g. auditory, visual and proprioceptive stimuli) revealed no abnormalities attributable to the treatment. Grip strength and Motor activity values observed in male and female animals for control and different dose groups were comparable. At the end of the dosing period on day 29, no statistically significant changes in the values of various hematological parameters and at the end of the recovery period on day 43, statistically significant decrease in the values of Total RBC at 1000 mg/kg, male. In female animals conducted at the end of the dosing period on day 29, statistically significant decrease in the values of MCHC at 250 mg/kg, female and at the end of the recovery period on day 43, no statistically significant changes in the values of various parameters were observed. The decrease in the values of various parameters was marginal and within the normal biological and laboratory limits. In male and female animals conducted at the end of the dosing period on day 29, statistically significant increase in the values of Sodium at 500 mg/kg in male. In addition, statistically significant decrease was observed in the values of Glucose and Total Cholesterol at 500 mg/kg, Calcium at 250 mg/kg, 500 mg/kg and 1000 mg/kg in male and Blood Urea Nitrogen and Urea Nitrogen at 250 and 1000 mg/kg in female. At the end of the recovery period on day 43 (Reversal groups) statistically significant increase were observed in the values of Total Protein, Globulin, Creatinine and Triglycerides at 1000 mg/kg in male and Total Protein, Glucose, Albumin and Globulin at 1000 mg/kg in female. In addition, statistically significant decrease was observed in the values of Bile Acid at 1000 mg/kg in male rats. The increase/decrease in the values of various parameters was marginal and within the normal biological and laboratory limits. Urine analysis conducted during 4th and 6th week of dosing period (on day 26, 27 and 43) no abnormality was attributable to the treatment. In addition, at termination of dosing on day 29, male animals at 250, 500 and 1000 mg/kg dose groups revealed increased relative weights of liver when compared with that of controls. In addition, increased relative weights of heart were observed in male animals at 500 mg/kg dose group as compared to controls. In male animals sacrificed on day 43 at 1000 mg/kg reversal group, was found to be comparable with that of controls. At termination of dosing on day 29, at 500 and 1000 mg/kg dose groups revealed increased relative weights of liver and sacrificed on day 43 from 1000 mg/kg reversal group, revealed decreased relative weights of kidneys, adrenals and ovaries in female when compared with that of controls. Although significant changes in the values of organ weight were observed in male and female animals from different dose groups, no related gross pathological and histopathological findings were seen, hence these findings were considered to be of no toxicological importance. Test item coloured perianal region externally and test item coloured stomach mucosa in male and female at 250, 500 and 1000 mg/kg dose groups. In male and female animals from control, control reversal and 1000 mg/kg reversal dose groups did not reveal any abnormality. Although significant gross pathological observations were noted in male and female animals from different dose groups, no related histopathological changes were observed. Histopathological examination did not reveal any abnormality attributable to the treatment. Therefore, No Observed Adverse Effect Level (NOAEL) of the test chemical in the Sprague Dawley rat via oral route, over a period of 28 days was found to be 1000 mg/kg body weight in male and female animals.   Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation.   Repeated dose toxicity: Inhalation According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance  9,10-Anthracenedione, 1,4-diamino-, N,N'-bis (4-C7-17-branched alkylphenyl) derivs (CAS no. 97862-23-2), which is reported as 1.05E-14Pa at 25 C. Also, the acute inhalation LC50 value is considered t be 5mg/L. Thus, exposure to inhalable dust, mist and vapour of the chemical substance9,10-Anthracenedione, 1,4-diamino-, N,N'-bis (4-C7-17-branched alkylphenyl) derivs is highly unlikely. Therefore this endpoint for repeated dose toxicity by inhalation route of exposure is considered for waiver.   Repeated dose toxicity: Dermal The acute toxicity value for 9,10-Anthracenedione, 1,4-diamino-, N,N'-bis (4-C7-17-branched alkylphenyl) derivs (CAS no 97862-23-2) (as provided in section 7.2.3) is >2000 mg/kg b.wt.mg/kg body weight by a study report . Also, given the use of the chemica, repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 10-Anthracenedione, 1,4-diamino-, N,N'-bis (4-C7-17-branched alkylphenyl) derivs. shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that,10-Anthracenedione, 1,4-diamino-, N,N'-bis (4-C7-17-branched alkylphenyl) derivs. shall exhibit repeated dose toxicity by the dermal route. Hence this end point for repeated dose toxicity by dermal route of exposure was considered for waiver.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bd87a2c-2092-4796-89e6-387b4921f23c/documents/d8765adc-32cc-4f74-b084-d84adaf40f15_b02b5dba-ed29-447a-bc97-4a6e682a49fc.html,,,,,, "9,10-Anthracenedione, 1,4-diamino-, N,N'-bis(4-C7-17-branched alkylphenyl) derivs.",97862-23-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bd87a2c-2092-4796-89e6-387b4921f23c/documents/d8765adc-32cc-4f74-b084-d84adaf40f15_b02b5dba-ed29-447a-bc97-4a6e682a49fc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "9,10-Anthracenedione, 1,4-diamino-, N,N'-bis(4-C7-17-branched alkylphenyl) derivs.",97862-23-2,Acute Oral Toxicity: The LD50 value of the test compound was determined to be more than 2000 mg/kg bw (>2000 mg/kg bw) when Sprague Dawley female rats treated via oral gavage route.   Acute inhalation toxicity: LC50 of test compound was determined be more than 5 mg/L. when Wistar Albino Male and Female rats were inhaled for 4 hours.   Acute dermal toxicity: LD50 of test compound was determined to be more than 2000 mg/kg b.wt (>2000 mg/kg b.wt.) when Wistar albino male and female rats treated dermally.   ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bd87a2c-2092-4796-89e6-387b4921f23c/documents/64c03d74-a0f3-4b2e-bf13-a1b510401d88_b02b5dba-ed29-447a-bc97-4a6e682a49fc.html,,,,,, "9,10-Anthracenedione, 1,4-diamino-, N,N'-bis(4-C7-17-branched alkylphenyl) derivs.",97862-23-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bd87a2c-2092-4796-89e6-387b4921f23c/documents/64c03d74-a0f3-4b2e-bf13-a1b510401d88_b02b5dba-ed29-447a-bc97-4a6e682a49fc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "9,10-Anthracenedione, 1,4-diamino-, N,N'-bis(4-C7-17-branched alkylphenyl) derivs.",97862-23-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bd87a2c-2092-4796-89e6-387b4921f23c/documents/64c03d74-a0f3-4b2e-bf13-a1b510401d88_b02b5dba-ed29-447a-bc97-4a6e682a49fc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "9,10-Anthracenedione, 1,4-diamino-, N,N'-bis(4-C7-17-branched alkylphenyl) derivs.",97862-23-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bd87a2c-2092-4796-89e6-387b4921f23c/documents/64c03d74-a0f3-4b2e-bf13-a1b510401d88_b02b5dba-ed29-447a-bc97-4a6e682a49fc.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "9,10-Anthracenedione, 1,4-diamino-, N,N'-mixed 2-ethylhexyl and 3-[(2-ethylhexyl)oxy]propyl and 3-methoxypropyl derivs.",90170-70-0," Read Across approach used to analogue substance. Assumption that target substance will have the same properties. Available data for the source subtance Solvent Blue 98: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, oral (gavage), rat , M/F, OECD guideline 422, GLP ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b89dabc-a060-4972-ac00-ff10178ffde5/documents/bb790356-17dc-40c9-91ae-621669046189_afd2d0d4-b052-474b-b73b-9a0aa9db66a0.html,,,,,, "9,10-Anthracenedione, 1,4-diamino-, N,N'-mixed 2-ethylhexyl and 3-[(2-ethylhexyl)oxy]propyl and 3-methoxypropyl derivs.",90170-70-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b89dabc-a060-4972-ac00-ff10178ffde5/documents/bb790356-17dc-40c9-91ae-621669046189_afd2d0d4-b052-474b-b73b-9a0aa9db66a0.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat "9,10-Anthracenedione, 1,4-diamino-, N,N'-mixed 2-ethylhexyl and 3-[(2-ethylhexyl)oxy]propyl and 3-methoxypropyl derivs.",90170-70-0," Acute oral toxicity: LD50 > 2000 mg/kg bw, EU Method B.1 tris, OECD 423, GLP compliant ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b89dabc-a060-4972-ac00-ff10178ffde5/documents/9553daa4-77c4-4ce0-acad-72f287829934_afd2d0d4-b052-474b-b73b-9a0aa9db66a0.html,,,,,, "9,10-Anthracenedione, 1,4-diamino-, N,N'-mixed 2-ethylhexyl and 3-[(2-ethylhexyl)oxy]propyl and 3-methoxypropyl derivs.",90170-70-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b89dabc-a060-4972-ac00-ff10178ffde5/documents/9553daa4-77c4-4ce0-acad-72f287829934_afd2d0d4-b052-474b-b73b-9a0aa9db66a0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "9,10-Anthracenedione, 1,4-diamino-, N,N'-mixed 2-ethylhexyl and hexyl and octyl derivs.",93762-42-6," Repeated dose toxicity: Oral The No Observed Adverse Effect Level (NOAEL) of the test chemical in the rat via oral route of exposure is considered to be 1000 mg/kg body weight in male and female animals. Repeated dose toxicity: Inhalation Test chemical has very low vapor pressure of 9.7058E-10 Pa (7.279e-12 mmHg), so the potential for the generation of inhalable vapours is very low, also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route of exposure was considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d7760e3-9adb-4f9a-b4a7-9a705644c4d9/documents/5aeccf8d-f2be-4719-9994-7f0949bd67a6_4dad1cef-ea92-4069-b873-58c08da47aa2.html,,,,,, "9,10-Anthracenedione, 1,4-diamino-, N,N'-mixed 2-ethylhexyl and hexyl and octyl derivs.",93762-42-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d7760e3-9adb-4f9a-b4a7-9a705644c4d9/documents/5aeccf8d-f2be-4719-9994-7f0949bd67a6_4dad1cef-ea92-4069-b873-58c08da47aa2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "9,10-Anthracenedione, 1,4-diamino-, N,N'-mixed 2-ethylhexyl and hexyl and octyl derivs.",93762-42-6," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The studies concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity dose (LC50) was considered based on experimental study conducted on rats for the given test chemical. The study concluded that the LC50 value is >5 mg/L (>5000 mg/m3), for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute inhalation toxicity. Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on study conducted on rats for the test chemical. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d7760e3-9adb-4f9a-b4a7-9a705644c4d9/documents/7246c9bd-d4a6-4e22-88ff-c20d4bda88f1_4dad1cef-ea92-4069-b873-58c08da47aa2.html,,,,,, "9,10-Anthracenedione, 1,4-diamino-, N,N'-mixed 2-ethylhexyl and hexyl and octyl derivs.",93762-42-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d7760e3-9adb-4f9a-b4a7-9a705644c4d9/documents/7246c9bd-d4a6-4e22-88ff-c20d4bda88f1_4dad1cef-ea92-4069-b873-58c08da47aa2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "9,10-Anthracenedione, 1,4-diamino-, N,N'-mixed 2-ethylhexyl and hexyl and octyl derivs.",93762-42-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d7760e3-9adb-4f9a-b4a7-9a705644c4d9/documents/7246c9bd-d4a6-4e22-88ff-c20d4bda88f1_4dad1cef-ea92-4069-b873-58c08da47aa2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "9,10-Anthracenedione, 1,4-diamino-, N,N'-mixed 2-ethylhexyl and hexyl and octyl derivs.",93762-42-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d7760e3-9adb-4f9a-b4a7-9a705644c4d9/documents/7246c9bd-d4a6-4e22-88ff-c20d4bda88f1_4dad1cef-ea92-4069-b873-58c08da47aa2.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthylium, salt with 4,5-dihydro-5-oxo-1-(4-sulphophenyl)-4-[(4-sulphophenyl)azo]-1H-pyrazole-3-carboxylic acid (3:1)",65138-66-1, LD50 was estimated to be 6519 mg/kg bw when Wistar male and female rats were orally exposed with Wistar. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ada7abba-d386-4412-8b6f-383e8b6e4112/documents/8bc67a4d-07e4-48bd-a161-2c3da2d87a6c_e37f94a2-47d1-4a93-9210-6aec0aa196a5.html,,,,,, "9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethylxanthylium, salt with 4,5-dihydro-5-oxo-1-(4-sulphophenyl)-4-[(4-sulphophenyl)azo]-1H-pyrazole-3-carboxylic acid (3:1)",65138-66-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ada7abba-d386-4412-8b6f-383e8b6e4112/documents/8bc67a4d-07e4-48bd-a161-2c3da2d87a6c_e37f94a2-47d1-4a93-9210-6aec0aa196a5.html,,oral,LD50,"6,519 mg/kg bw",no adverse effect observed, "9-Anthracenecarboxylic acid, (triethoxysilyl)methyl ester",313482-99-4, Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 423; GLP) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29340c7b-a4af-478d-a0e1-b57ce79eab1a/documents/c0732532-7f25-43e7-988c-eed840488088_a909feea-83b3-4a4e-9ec8-7bd2419263c7.html,,,,,, "9beta,11beta-Epoxy-6alpha-fluoro-16alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione",65535-29-7,"The acute toxicity (LD50) of epoxide valerate in rats is > 2000 mg/kg bw after oral administration (Rusch and Flowers, 1991) and after dermal application (Kurth, 1996).     Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is of good quality (Klimisch score = 1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study is of good quality (Klimisch score = 1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3702af76-42c8-466f-875f-79bb0b5f86eb/documents/0cfb9b73-9e6f-48b1-9be1-333392729048_6bac0588-7bc8-41ab-bdc4-a8f3e25db27e.html,,,,,, "9beta,11beta-Epoxy-6alpha-fluoro-16alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione",65535-29-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3702af76-42c8-466f-875f-79bb0b5f86eb/documents/0cfb9b73-9e6f-48b1-9be1-333392729048_6bac0588-7bc8-41ab-bdc4-a8f3e25db27e.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "9beta,11beta-Epoxy-6alpha-fluoro-16alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione",65535-29-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3702af76-42c8-466f-875f-79bb0b5f86eb/documents/0cfb9b73-9e6f-48b1-9be1-333392729048_6bac0588-7bc8-41ab-bdc4-a8f3e25db27e.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Methyl dec-9-enoate,25601-41-6,"Migrated Data from field(s)Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP compliant studies have been conducted according to OECD Guideline 422 and OECD Guideline 408 and are adequately reported. As such the studies are assigned reliability 1. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9404807f-4738-4f35-abd5-afc18e6ef613/documents/4e69cdae-c0d3-4e25-998c-577821fb742e_66a87711-a9e5-4378-a2c2-26a7f5147bd2.html,,,,,, Methyl dec-9-enoate,25601-41-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9404807f-4738-4f35-abd5-afc18e6ef613/documents/4e69cdae-c0d3-4e25-998c-577821fb742e_66a87711-a9e5-4378-a2c2-26a7f5147bd2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Methyl dec-9-enoate,25601-41-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9404807f-4738-4f35-abd5-afc18e6ef613/documents/e5c9678c-072b-4e23-8cc5-6fba9cd8c9a0_66a87711-a9e5-4378-a2c2-26a7f5147bd2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl dec-9-enoate,25601-41-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9404807f-4738-4f35-abd5-afc18e6ef613/documents/e5c9678c-072b-4e23-8cc5-6fba9cd8c9a0_66a87711-a9e5-4378-a2c2-26a7f5147bd2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-((R)-amino-1,2,3,4-tetrahydrocarbazol-9-yl)propanoic acid",1182722-58-2,"The test substance is non toxic after single oral exposure (LD50, rat: > 2000 mg/kg bw). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e977fa8f-f8e9-4066-af24-57365305aa9f/documents/IUC5-721558b1-291b-49d1-9a1c-b5d8d914de18_d08a1662-7ca1-49e1-af8d-490076d899a1.html,,,,,, "3-((R)-amino-1,2,3,4-tetrahydrocarbazol-9-yl)propanoic acid",1182722-58-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e977fa8f-f8e9-4066-af24-57365305aa9f/documents/IUC5-721558b1-291b-49d1-9a1c-b5d8d914de18_d08a1662-7ca1-49e1-af8d-490076d899a1.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "9,9'-([1,1'-biphenyl]-4,4'-diyl)di(9H-fluoren-9-ol)",427165-44-4,"The test substance is of low oral acute toxicity with an oral LD50 (rat) of > 2000 mg/kg bw (LPT, 2014). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dbea8be-6a59-49f5-8b3a-61219a70bea6/documents/IUC5-ae572aa6-ce4f-41af-96c7-2745fa81658c_e8f670a8-e2cb-4102-a895-3efec5374877.html,,,,,, 9H-fluoren-9-ylmethyl chloroformate,28920-43-6," According to our supplier's MSDS, 9H-fluoren-9-ylmethyl chloroformate is extremely destructive to the tissue of the mucous membranes and upper respiratory tract. No published data other than those from the supplier. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f87e868-bf28-4f3d-af7d-9602aa5510f2/documents/d62281e4-df13-475a-a6c1-2c671e1f880d_f5cb32ed-6afa-4bc8-a743-34d50d4f9374.html,,,,,, 9H-fluoren-9-ylmethyl chloroformate,28920-43-6," According to our supplier's MSDS, 9H-fluoren-9-ylmethyl chloroformate may be harmful by inhalation, in contact with skin and if swallowed. There are no published data other than those from the supplier. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f87e868-bf28-4f3d-af7d-9602aa5510f2/documents/ffc060ed-d91e-4946-a489-204080b56b66_f5cb32ed-6afa-4bc8-a743-34d50d4f9374.html,,,,,, "9-Octadecen-1-ol, (Z)-, phosphate",37310-83-1,Oral: NOAEL > 1000 mg/kg bw; rat; according to OECD TG 407; GLP; K1 Inhalation: no information available Dermal: no information available ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14b0dc4c-27d9-4eaf-bd39-3085010d0d15/documents/IUC5-df280d27-e3ef-4b06-85ad-d3990c31a773_2953252a-66ff-4edf-9599-2cb022312693.html,,,,,, "9-Octadecen-1-ol, (Z)-, phosphate",37310-83-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14b0dc4c-27d9-4eaf-bd39-3085010d0d15/documents/IUC5-df280d27-e3ef-4b06-85ad-d3990c31a773_2953252a-66ff-4edf-9599-2cb022312693.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "9-Octadecen-1-ol, (Z)-, phosphate",37310-83-1,Oral: LD50 > 2000 mg/kg bw; rat; according to OECD TG 423; GLP; K1 Dermal: LD50 > 2000 mg/kg bw; rat; according to OECD TG 402; GLP; K1 Inhalation: no information available ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14b0dc4c-27d9-4eaf-bd39-3085010d0d15/documents/IUC5-a26bcc46-6fda-4c37-8ab2-78bf4ec2eadf_2953252a-66ff-4edf-9599-2cb022312693.html,,,,,, "9-Octadecen-1-ol, (Z)-, phosphate",37310-83-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14b0dc4c-27d9-4eaf-bd39-3085010d0d15/documents/IUC5-a26bcc46-6fda-4c37-8ab2-78bf4ec2eadf_2953252a-66ff-4edf-9599-2cb022312693.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "9-Octadecen-1-ol, (Z)-, phosphate",37310-83-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14b0dc4c-27d9-4eaf-bd39-3085010d0d15/documents/IUC5-a26bcc46-6fda-4c37-8ab2-78bf4ec2eadf_2953252a-66ff-4edf-9599-2cb022312693.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "9-Octadecenamide, N-[(1S,2S,3R)-2,3-dihydroxy-1-(hydroxymethyl)heptadecyl]-, (9Z)-",178436-06-1," Acute toxicity: oral - Key study, read-across, source substance Ceramide III, OECD guideline 401 and EU Method B.1, GLP, Reliability 1: Oral LD50 (rat) > 5000 mg/kg bodyweight - Supporting study, target substance Ceramide IIIB, similar to OECD guideline 401, Reliability 2: Oral LD50 (rat) > 2000 mg/kg bodyweight Acute toxicity: dermal - Key study, target substance Ceramide IIIB, similar to OECD guideline 402, Reliability 2: Dermal LD50 (rat) > 2000 mg/kg bodyweight ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/206a9f3a-388e-4c79-9b1c-1f089e40e427/documents/5d5498cd-130d-45f2-8a1f-b675aca7a311_d34146eb-5a61-4026-b4e8-174a97908c92.html,,,,,, "9-Octadecenamide, N-[(1S,2S,3R)-2,3-dihydroxy-1-(hydroxymethyl)heptadecyl]-, (9Z)-",178436-06-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/206a9f3a-388e-4c79-9b1c-1f089e40e427/documents/5d5498cd-130d-45f2-8a1f-b675aca7a311_d34146eb-5a61-4026-b4e8-174a97908c92.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "9-Octadecenamide, N-[(1S,2S,3R)-2,3-dihydroxy-1-(hydroxymethyl)heptadecyl]-, (9Z)-",178436-06-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/206a9f3a-388e-4c79-9b1c-1f089e40e427/documents/5d5498cd-130d-45f2-8a1f-b675aca7a311_d34146eb-5a61-4026-b4e8-174a97908c92.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Octadec-9-ene-1,18-dioic acid",4494-16-0,Oral: LD50 > 2000 mg/kg bw ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5adb8e20-b897-4473-801e-508924dcfde7/documents/IUC5-dafd5b33-abe8-4fde-b847-72c16b9278eb_c52f6852-5b05-4946-b360-00303ae54f01.html,,,,,, "9-Octadecenoic acid (Z)-, isooctyl ester, reaction products with glycerol trioleate and sulfur",96152-40-8,"The test material was determined to have a NOAEL of 1000 mg/kg/day in an OECD 422 reproduction screening study performed on the analogue substance, CAS # 61789-01-3 Fatty acids, tall-oil, epoxidized, 2-ethylhexyl esters. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce900dd5-b9dd-4f3d-8776-917c2f18e01f/documents/IUC5-acd88e3f-82f3-4545-8db6-59ed67779ae5_a6531de8-7e10-4a39-8f56-e7ca8616aa9c.html,,,,,, "9-Octadecenoic acid (Z)-, isooctyl ester, reaction products with glycerol trioleate and sulfur",96152-40-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce900dd5-b9dd-4f3d-8776-917c2f18e01f/documents/IUC5-acd88e3f-82f3-4545-8db6-59ed67779ae5_a6531de8-7e10-4a39-8f56-e7ca8616aa9c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "9-Octadecenoic acid (Z)-, isooctyl ester, reaction products with glycerol trioleate and sulfur",96152-40-8,"ORAL: LD50 = > 5000 mg/kg male/female rat; OECD 401, EU Method B.1; Guillot & Lheritier, 1986aDERMAL: LD50 = > 2000 mg/kg male/female rat; OECD 402, EU Method B.3; Guillot & Lheritier, 1986bINHALATION: no study available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce900dd5-b9dd-4f3d-8776-917c2f18e01f/documents/IUC5-baef5f29-c22a-4120-8d6c-7494ff6f1322_a6531de8-7e10-4a39-8f56-e7ca8616aa9c.html,,,,,, "9-Octadecenoic acid (Z)-, monoester with 1,2,3-propanetriol ester with boric acid (H3BO3)",63310-16-7,The test material was determined to have a NOAEL of 1000 mg/kg/day in a 28 day repeat dose study performed in accordance with OECD 410. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86692a89-6e4a-4a04-b8d6-11c41c395357/documents/941d3a9e-801f-44d1-ab7c-932761052ad2_0f98de0d-7b1f-42b1-93a8-f8ac04b79b47.html,,,,,, "9-Octadecenoic acid (Z)-, monoester with 1,2,3-propanetriol ester with boric acid (H3BO3)",63310-16-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86692a89-6e4a-4a04-b8d6-11c41c395357/documents/941d3a9e-801f-44d1-ab7c-932761052ad2_0f98de0d-7b1f-42b1-93a8-f8ac04b79b47.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "9-Octadecenoic acid (Z)-, monoester with 1,2,3-propanetriol ester with boric acid (H3BO3)",63310-16-7,"ORAL: LD50 = > 5000 mg/kg male/female rat, OECD 401, EU Method B.1, Korenaga et al. (1983) & Bullock et al. (1982)DERMAL: LD50 = > 5000 mg/kg male/female rat, OECD 402, EU Method B.3, Korenaga et al. (1983) & Bullock et al. (1982) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86692a89-6e4a-4a04-b8d6-11c41c395357/documents/68835a48-2c25-4535-9f0d-8e9b332b9bd6_0f98de0d-7b1f-42b1-93a8-f8ac04b79b47.html,,,,,, "9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol",68815-51-0,"In an enhanced OECD guideline 422 study that was performed in compliance with GLP the NOAEL for general, systemic toxicity of the test substance was determined to be 1000 mg/kg body weight/day for the F0 parental animals, the highest dose tested. The NOEL (no observed effect level) is 10 mg/kg bw/d for the F0 parental rats based on treatment-related, local and non-adverse effects such as sinus histiocytosis in the mesenteric lymph nodes at 300 and 1000 mg/kg bw/d and granulomatous inflammation of one lung lobe with no corroborative clinical or pathological findings indicative of systemic toxicity at 100, 300 and 1000 mg/kg bw/d. (BASF SE, 2010). ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/370a14ce-5c19-4eb9-a3e7-8409a30187e6/documents/IUC5-d2894659-a750-44f1-a972-911e672057ad_12780069-0ac4-4e97-8bd5-91aa2a316cee.html,,,,,, "9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol",68815-51-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/370a14ce-5c19-4eb9-a3e7-8409a30187e6/documents/IUC5-d2894659-a750-44f1-a972-911e672057ad_12780069-0ac4-4e97-8bd5-91aa2a316cee.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "9-Octadecenoic acid (Z)-, reaction products with 2-[(2-aminoethyl)amino]ethanol",68815-51-0,"Acute oral toxicity: LD50, rat: > 2000 mg/kg bwAcute dermal toxicity: LD50, rat: > 2000 mg/kg bwAcute inhalation toxicity: There are no data available concerning acute inhalation toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/370a14ce-5c19-4eb9-a3e7-8409a30187e6/documents/IUC5-bf06b590-db3d-4f19-b189-5495304ab224_12780069-0ac4-4e97-8bd5-91aa2a316cee.html,,,,,, "9-Octadecenoic acid (Z)-, sulfonated, potassium salts",68609-93-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53519e17-2479-4e8b-8122-ca7d9ad8f4d5/documents/IUC5-ac5a667e-e858-449f-b23f-d544f14722b5_a2848cc4-1802-41a9-8649-145d1e7b0547.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "9-Octadecenoic acid (Z)-, sulfonated, potassium salts",68609-93-8," The available data suggests that 9-Octadecenoic acid (Z)-, sulfonated, potassium salts has a low potential for acute oral (LD50 >2,723 mg/kg bw) and dermal toxicity (LD50 >2,000 mg/kg bw). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53519e17-2479-4e8b-8122-ca7d9ad8f4d5/documents/IUC5-3885d569-0449-4174-8906-7137041456ac_a2848cc4-1802-41a9-8649-145d1e7b0547.html,,,,,, "9-Octadecenoic acid (Z)-, sulfonated, potassium salts",68609-93-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53519e17-2479-4e8b-8122-ca7d9ad8f4d5/documents/IUC5-3885d569-0449-4174-8906-7137041456ac_a2848cc4-1802-41a9-8649-145d1e7b0547.html,,oral,LD50,"2,723 mg/kg bw",no adverse effect observed, "9-Octadecenoic acid (Z)-, sulfonated, potassium salts",68609-93-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53519e17-2479-4e8b-8122-ca7d9ad8f4d5/documents/IUC5-3885d569-0449-4174-8906-7137041456ac_a2848cc4-1802-41a9-8649-145d1e7b0547.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "9-Octadecenoic acid (Z)-, zinc salt, basic",90480-27-6,"Fourteen-day repeat dose toxicity study using the oral route by gavage in the rat, conducted according to a range-finder standard procedure under GLP, and followed by a twenty-eight day repeat oral (gavage) study in the rat. The NOAEL for systemic toxicity was found to be 1000 mg/kg bw/day (OECD 422). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df1d942b-7bd6-4dd0-b6b0-4632f91c2100/documents/IUC5-80cf273c-a506-4dce-a1d8-9d35421bf667_f611953f-7ca7-474e-93f3-558bf6827e32.html,,,,,, "9-Octadecenoic acid (Z)-, zinc salt, basic",90480-27-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df1d942b-7bd6-4dd0-b6b0-4632f91c2100/documents/IUC5-80cf273c-a506-4dce-a1d8-9d35421bf667_f611953f-7ca7-474e-93f3-558bf6827e32.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "9-Octadecenoic acid (Z)-, zinc salt, basic",90480-27-6,In a study similar to US EPA OPP 81 -1 the test chemical was subjected to oral toxicity testing in rats of both sexes by oral gavage dosing at 5000mg/kg bw.OECD Guideline 402 and EU Method B.3 (Acute Toxicity (Dermal)) A group of Wistar (RccHanTM:WIST) rats (5/sex/dose) were given a single dermal application of test item at 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df1d942b-7bd6-4dd0-b6b0-4632f91c2100/documents/IUC5-83a93d26-ecfd-4d1e-8e96-18ca3b913d7a_f611953f-7ca7-474e-93f3-558bf6827e32.html,,,,,, "A mixture mainly based on: 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene; 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene",163702-01-0, Study conducted to recognised testing guidelines with GLP certification. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7def2640-17f1-4b2f-ad7a-8af573d44071/documents/56854279-da53-46c6-b2e9-a254f07549b3_0a82a1b8-086e-49f4-9d6f-48055c5ed4ef.html,,,,,, "A mixture mainly based on: 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene; 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene",163702-01-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7def2640-17f1-4b2f-ad7a-8af573d44071/documents/56854279-da53-46c6-b2e9-a254f07549b3_0a82a1b8-086e-49f4-9d6f-48055c5ed4ef.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat "A mixture mainly based on: 2,3-dihydro-6-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene; 2,3-dihydro-5-(2-hydroxy-2-methyl-1-oxopropyl)-1,1,3-trimethyl-3-[4-(2-hydroxy-2-methyl-1-oxopropyl)phenyl]-1H-indene",163702-01-0, Study conducted to recognised testing guidelines with GLP certification. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7def2640-17f1-4b2f-ad7a-8af573d44071/documents/80e6e911-3e1d-4625-b8f5-a047b9992c19_0a82a1b8-086e-49f4-9d6f-48055c5ed4ef.html,,,,,, "A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates",127519-17-9,"28 day study: NOAEL (male/female) = 50 mg/kg bw (OECD Guideline Study, CIBA, 1991) NOEL (male/female) = 2 mg/kg bw LOAEL (male/female) = 500 mg/kg bw ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5724935-528e-4bb0-95cc-482e45a71a77/documents/IUC5-174ff424-6c5a-4934-84ea-6653e262ce0d_5a9ee6ac-3198-4dea-a34f-f1881447ba64.html,,,,,, "A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates",127519-17-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5724935-528e-4bb0-95cc-482e45a71a77/documents/IUC5-174ff424-6c5a-4934-84ea-6653e262ce0d_5a9ee6ac-3198-4dea-a34f-f1881447ba64.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,2 mg/kg bw/day,,rat "A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates",127519-17-9,"Oral: LD50 > 2000 mg/kg (male/female), OECD Guideline Study, Ciba-Geigy, 1990Dermal: LD50 > 2000 mg/kg (male/female), OECD Guideline Study, Ciba-Geigy, 1990 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5724935-528e-4bb0-95cc-482e45a71a77/documents/IUC5-3b60f7ec-8e47-4684-9049-e13ddb9349cb_5a9ee6ac-3198-4dea-a34f-f1881447ba64.html,,,,,, "A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates",127519-17-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5724935-528e-4bb0-95cc-482e45a71a77/documents/IUC5-3b60f7ec-8e47-4684-9049-e13ddb9349cb_5a9ee6ac-3198-4dea-a34f-f1881447ba64.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates",127519-17-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5724935-528e-4bb0-95cc-482e45a71a77/documents/IUC5-3b60f7ec-8e47-4684-9049-e13ddb9349cb_5a9ee6ac-3198-4dea-a34f-f1881447ba64.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "A mixture of branched and linear C7-C9 alkyl 3-[3-(2H-benzotriazol-2-yl)-5-(1,1-dimethylethyl)-4-hydroxyphenyl]propionates",127519-17-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5724935-528e-4bb0-95cc-482e45a71a77/documents/IUC5-3b60f7ec-8e47-4684-9049-e13ddb9349cb_5a9ee6ac-3198-4dea-a34f-f1881447ba64.html,,inhalation,discriminating conc.,5.8 mg/m3,no adverse effect observed, A mixture of isomers of: mono-(2-tetradecyl)naphthalenes; di-(2-tetradecyl)naphthalenes; tri-(2-tetradecyl)naphthalenes,132983-41-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5544b36a-e9de-44ad-93ab-38b902b2ea70/documents/IUC5-b85f2288-bc03-4b2f-8708-69c73b1b4d23_13aa8603-9a60-4c67-867c-305f3ddac8a2.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat A mixture of isomers of: mono-(2-tetradecyl)naphthalenes; di-(2-tetradecyl)naphthalenes; tri-(2-tetradecyl)naphthalenes,132983-41-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5544b36a-e9de-44ad-93ab-38b902b2ea70/documents/IUC5-b85f2288-bc03-4b2f-8708-69c73b1b4d23_13aa8603-9a60-4c67-867c-305f3ddac8a2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,470 mg/kg bw/day",,rat "A mixture of: 2,2,6,6-tetramethylpiperidin-4-yl-hexadecanoate; 2,2,6,6-tetramethylpiperidin-4-yl-octadecanoate",86403-32-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce8085aa-79e4-4b61-bb56-35d16b77d853/documents/IUC5-8c376ce5-ee85-4728-9531-81699a581514_12a65260-34b2-4a04-aafd-4c6330babbba.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat "A mixture of: 2,2,6,6-tetramethylpiperidin-4-yl-hexadecanoate; 2,2,6,6-tetramethylpiperidin-4-yl-octadecanoate",86403-32-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce8085aa-79e4-4b61-bb56-35d16b77d853/documents/IUC5-c0bc5db5-012d-402f-87ae-e9631bad40fc_12a65260-34b2-4a04-aafd-4c6330babbba.html,,oral,LD50,"15,000 mg/kg bw",, "A mixture of: 2,2,6,6-tetramethylpiperidin-4-yl-hexadecanoate; 2,2,6,6-tetramethylpiperidin-4-yl-octadecanoate",86403-32-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce8085aa-79e4-4b61-bb56-35d16b77d853/documents/IUC5-c0bc5db5-012d-402f-87ae-e9631bad40fc_12a65260-34b2-4a04-aafd-4c6330babbba.html,,dermal,LD50,"5,000 mg/kg bw",, "A mixture of: 2,2,6,6-tetramethylpiperidin-4-yl-hexadecanoate; 2,2,6,6-tetramethylpiperidin-4-yl-octadecanoate",86403-32-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce8085aa-79e4-4b61-bb56-35d16b77d853/documents/IUC5-c0bc5db5-012d-402f-87ae-e9631bad40fc_12a65260-34b2-4a04-aafd-4c6330babbba.html,,inhalation,LC50,5 mg/m3,, "A mixture of: 4-(2,2,3-trimethylcyclopent-3-en-1-yl)-1-methyl-2-oxabicyclo[2.2.2]octane; 1-(2,2,3-trimethylcyclopent-3-en-1-yl)-5-methyl-6-oxabicyclo[3.2.1]octane; spiro[cyclohex-3-en-1-yl-[(4,5,6,6a-tetrahydro-3,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]furan]; spiro[cyclohex-3-en-1-yl-[4,5,6,6a-tetrahydro-4,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]]furan]",426218-78-2,"28 -day repeated dose (oral) (OECD TG 407): The NOAEL was determined to be ≥1000 mg/kg bw/day for males and females, as no adverse effects were observed at a dose of 1000 mg/kg/day. This value will be used for the risk assessment. Reproscreening test (OECD TG 421): Treatment with the substance by dietary administration in male and female Wistar Han rats at dose levels of 1.000, 2.500 and 8.000 ppm (circa 70, 170 and 550 mg/kg bw/day) revealed slight non-adverse female toxicity at 550 mg/kg bw/day. The NOAEL was determined to be >550 mg/kg bw/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The database consists of 2 studies which are carried out according to current guidelines which confirm the results found and therefore the quality of the database is high. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8dc33153-47ba-48ba-a989-51d7fb08ea5b/documents/IUC5-6776d992-1252-458c-abd2-794ab51de166_67853b00-1a02-46ba-86fe-b48dc36114a3.html,,,,,, "A mixture of: 4-(2,2,3-trimethylcyclopent-3-en-1-yl)-1-methyl-2-oxabicyclo[2.2.2]octane; 1-(2,2,3-trimethylcyclopent-3-en-1-yl)-5-methyl-6-oxabicyclo[3.2.1]octane; spiro[cyclohex-3-en-1-yl-[(4,5,6,6a-tetrahydro-3,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]furan]; spiro[cyclohex-3-en-1-yl-[4,5,6,6a-tetrahydro-4,6',6',6'a-tetramethyl)-1,3'(3'aH)-[2H]cyclopenta[b]]furan]",426218-78-2,"Acute oral toxicity: LD50 is >2000 mg/kg bw in an OECD TG 401.  Acute toxicity inhalation: LC50 is >5200 mg/m^3 (route to route extrapolation). Acute dermal toxicity: LD50 is >2000 mg/kg bw in an OECD TG 402. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The one acute oral toxicity study available is of sufficient quality for the present dossier. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The acute inhalation toxicity is derived using route to route extrapolation from the acute toxicity results, using 100% absorption. This assessment is considered to be sufficiently adequate for covering this endpoint. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The one acute dermal toxicity study available is of sufficient quality for the present dossier. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dc33153-47ba-48ba-a989-51d7fb08ea5b/documents/IUC5-dae8e0ec-d62b-4767-8982-19e93f5a4c4a_67853b00-1a02-46ba-86fe-b48dc36114a3.html,,,,,, "A mixture of: 7,9,9-trimethyl-3,14-dioxa-4,13-dioxo-5,12-diazahexadecane-1,16-diylprop-2-enoate; 7,7,9-trimethyl-3,14-dioxa-4,13-dioxo-5,12-diazahexadecan-1,16-diylprop-2-enoate",52658-19-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd12f0d5-79a0-4782-b8fb-d0cb5e1580aa/documents/IUC5-57f40167-fc47-4043-b050-754617aa87be_8473f115-fe10-4c0f-9d8e-22c050e8e834.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "A mixture of: 7,9,9-trimethyl-3,14-dioxa-4,13-dioxo-5,12-diazahexadecane-1,16-diylprop-2-enoate; 7,7,9-trimethyl-3,14-dioxa-4,13-dioxo-5,12-diazahexadecan-1,16-diylprop-2-enoate",52658-19-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd12f0d5-79a0-4782-b8fb-d0cb5e1580aa/documents/IUC5-f2bfa6b5-a434-40d3-a889-8d81aee2fe6b_8473f115-fe10-4c0f-9d8e-22c050e8e834.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "A mixture of: 7,9,9-trimethyl-3,14-dioxa-4,13-dioxo-5,12-diazahexadecane-1,16-diylprop-2-enoate; 7,7,9-trimethyl-3,14-dioxa-4,13-dioxo-5,12-diazahexadecan-1,16-diylprop-2-enoate",52658-19-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd12f0d5-79a0-4782-b8fb-d0cb5e1580aa/documents/IUC5-f2bfa6b5-a434-40d3-a889-8d81aee2fe6b_8473f115-fe10-4c0f-9d8e-22c050e8e834.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "A mixture of: bis(2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-1,10-decanedioate; 1,8-bis[(2,2,6,6-tetramethyl-4-((2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-decan-1,10-dioyl)piperidin-1-yl)oxy]octane",129757-67-1," Oral administration of the test item to CD rats for 13-weeks produced non-specific toxicity at 1000 mg/kg/day, a reduction of dopamine and adaptive change in the liver at 150 or 1000 mg/kg/day. These changes were shown to be reversible during a subsequent four-week period without treatment. There was no treatment-related change at 25 mg/kg/day and this dosage was, therefore, considered the no-observed-effect level (NOEL) in this study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/95ec8f62-49cf-4942-b6e2-95c4facfca11/documents/IUC5-bbe518c4-856d-4086-aa9a-b87c81bd9371_cd5a2662-568f-4059-983e-eac4b7bb166e.html,,,,,, "A mixture of: bis(2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-1,10-decanedioate; 1,8-bis[(2,2,6,6-tetramethyl-4-((2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-decan-1,10-dioyl)piperidin-1-yl)oxy]octane",129757-67-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/95ec8f62-49cf-4942-b6e2-95c4facfca11/documents/IUC5-bbe518c4-856d-4086-aa9a-b87c81bd9371_cd5a2662-568f-4059-983e-eac4b7bb166e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat "A mixture of: bis(2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-1,10-decanedioate; 1,8-bis[(2,2,6,6-tetramethyl-4-((2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-decan-1,10-dioyl)piperidin-1-yl)oxy]octane",129757-67-1," Oral LD50 rat > 2000 mg/kg bw; transient signs of toxicity: Piloerection, hunched posture, exophthalmos, and dyspnea (OECD 401; 1989) Dermal LD50 rat > 2000 mg/kg bw; transient signs of toxicity: Piloerection, abnormal body positions, and dyspnea (OECD 402; 1989) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95ec8f62-49cf-4942-b6e2-95c4facfca11/documents/IUC5-744132b3-c1fe-4365-84ee-8aa351b95266_cd5a2662-568f-4059-983e-eac4b7bb166e.html,,,,,, "A mixture of: bis(2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-1,10-decanedioate; 1,8-bis[(2,2,6,6-tetramethyl-4-((2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-decan-1,10-dioyl)piperidin-1-yl)oxy]octane",129757-67-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95ec8f62-49cf-4942-b6e2-95c4facfca11/documents/IUC5-744132b3-c1fe-4365-84ee-8aa351b95266_cd5a2662-568f-4059-983e-eac4b7bb166e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "A mixture of: bis(2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-1,10-decanedioate; 1,8-bis[(2,2,6,6-tetramethyl-4-((2,2,6,6-tetramethyl-1-octyloxypiperidin-4-yl)-decan-1,10-dioyl)piperidin-1-yl)oxy]octane",129757-67-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95ec8f62-49cf-4942-b6e2-95c4facfca11/documents/IUC5-744132b3-c1fe-4365-84ee-8aa351b95266_cd5a2662-568f-4059-983e-eac4b7bb166e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "A mixture of: N,N-diethylpropane-1,3-diamine 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2,2-iminodiethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2-methylaminoethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate",114565-65-0,"For the oral route, a 28 day subacute toxicity study (RCC 255571) accompanied by a 5 day range finder (RCC 205582) are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d63b4f7-f27a-401b-aa55-5f506f94dcc2/documents/IUC5-b284e81d-48eb-4f19-96ca-a28a7291e086_f3c63c2e-39c3-442b-878f-f99d235c4d3e.html,,,,,, "A mixture of: N,N-diethylpropane-1,3-diamine 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2,2-iminodiethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2-methylaminoethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate",114565-65-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d63b4f7-f27a-401b-aa55-5f506f94dcc2/documents/IUC5-b284e81d-48eb-4f19-96ca-a28a7291e086_f3c63c2e-39c3-442b-878f-f99d235c4d3e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "A mixture of: N,N-diethylpropane-1,3-diamine 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2,2-iminodiethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate; 2-methylaminoethanol 6-methyl-2-(4-(2,4,6-triaminopyrimidin-5-ylazo)phenyl)benzothiazole-7-sulfonate",114565-65-0,"Referring to acute toxicity, validated GLP studies are available for the oral and the dermal route of exposure. No study is available for inhalation toxicity, however, it could be demonstrated that the conduct of such a study is scientifically unjustified.The acute oral toxicity was assessed in a study conducted according to OECD 401 (RCC 205514) and the LD50 was > 5000 mg/kg bwThe acute dermal toxicity was assessed in a study conducted according to OECD 402 (RCC 205525) and the LD50 was > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d63b4f7-f27a-401b-aa55-5f506f94dcc2/documents/IUC5-ecafc316-b0b4-42aa-8f36-761f9f2f1339_f3c63c2e-39c3-442b-878f-f99d235c4d3e.html,,,,,, "A mixture of: propan-2-one-O,O'(methoxyvinylsilandiyl)dioxime; propan-2-one-O-(dimethoxyvinylsilyl)oxime; propan-2-one-O,O',O''-(vinylsilantriyl)trioxime",797751-44-1," Key study (sub-acute): A Repeated dose 28-Day Oral toxicity Study in Rodents for the test substance was performed in rats. The No-observed-effect-level of the test substance was at 20 mg per kg body weight and day in both sexes. Key study (sub-chronic): Based on the read-across approach from the analogue substance OS2200, the sub-chronic NOAEL for the test substance was determined to be 13.22 mg/kg bw/day for general systemic toxicity. Key study (sub-acute): A short term inhalation repeated dose toxicity study is available for the degradation product methanol performed with a method similar to OECD Guideline 412. Rats exposed to up to 5010 ppm (6 hr/d, 5d/wk for 4 weeks) showed no treatment-related histopathological effects. Inhalation exposure only resulted in some slight treatment-related signs. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c42bb3f5-c49a-4e5a-9621-edd5ce06c043/documents/379efa6a-e0e8-4b7f-92cb-255ec603105c_ddeb9d1d-32e1-483f-9b1f-adaf35efb677.html,,,,,, "A mixture of: propan-2-one-O,O'(methoxyvinylsilandiyl)dioxime; propan-2-one-O-(dimethoxyvinylsilyl)oxime; propan-2-one-O,O',O''-(vinylsilantriyl)trioxime",797751-44-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c42bb3f5-c49a-4e5a-9621-edd5ce06c043/documents/379efa6a-e0e8-4b7f-92cb-255ec603105c_ddeb9d1d-32e1-483f-9b1f-adaf35efb677.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"6,677 mg/m3",,rat "A mixture of: propan-2-one-O,O'(methoxyvinylsilandiyl)dioxime; propan-2-one-O-(dimethoxyvinylsilyl)oxime; propan-2-one-O,O',O''-(vinylsilantriyl)trioxime",797751-44-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c42bb3f5-c49a-4e5a-9621-edd5ce06c043/documents/379efa6a-e0e8-4b7f-92cb-255ec603105c_ddeb9d1d-32e1-483f-9b1f-adaf35efb677.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,13.22 mg/kg bw/day,,rat "A mixture of: propan-2-one-O,O'(methoxyvinylsilandiyl)dioxime; propan-2-one-O-(dimethoxyvinylsilyl)oxime; propan-2-one-O,O',O''-(vinylsilantriyl)trioxime",797751-44-1, The acute oral median lethal dose (LD50) of test substance is higher than 2000 mg/kg body weight in rats. Also the LD50 dermal of the test substance was higher than 2000 mg/kg body weight in rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c42bb3f5-c49a-4e5a-9621-edd5ce06c043/documents/IUC5-80144a4f-6088-40dc-89e5-06c5e63d798d_ddeb9d1d-32e1-483f-9b1f-adaf35efb677.html,,,,,, "A mixture of: propan-2-one-O,O'(methoxyvinylsilandiyl)dioxime; propan-2-one-O-(dimethoxyvinylsilyl)oxime; propan-2-one-O,O',O''-(vinylsilantriyl)trioxime",797751-44-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c42bb3f5-c49a-4e5a-9621-edd5ce06c043/documents/IUC5-80144a4f-6088-40dc-89e5-06c5e63d798d_ddeb9d1d-32e1-483f-9b1f-adaf35efb677.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "A mixture of: propan-2-one-O,O'(methoxyvinylsilandiyl)dioxime; propan-2-one-O-(dimethoxyvinylsilyl)oxime; propan-2-one-O,O',O''-(vinylsilantriyl)trioxime",797751-44-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c42bb3f5-c49a-4e5a-9621-edd5ce06c043/documents/IUC5-80144a4f-6088-40dc-89e5-06c5e63d798d_ddeb9d1d-32e1-483f-9b1f-adaf35efb677.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "A mixture of: tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium ((1-(4(or 5)-nitro-2-oxidophenylazo)-2-naphtholato)(1-(3-nitro-2-oxido-5-pentylphenylazo)-2-naphtholato))chromate(1-)",117527-94-3,"The NOAEL for the test substance was determined at 50 mg/kg bw/d in a repeated dose (28-d) toxicity study in rats including a 14-day recovery period (OECD 407, GLP). At 200 mg/kg bw, males had a slightly reduced reticulocyte count. At 1000 mg/kg bw, males and females had a reduced reticulocyte count and a few other changes in heamatology. Two of ten females focal cortical hypertrophy in the adrenal gland. All findings were reversible during the 2-week recovery period. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e263e7b-700e-4e11-9651-2291e34ef14e/documents/IUC5-f7ad4333-5860-4a8f-ac21-1847221c9cfa_2d605b7f-6daa-4398-bb61-e425a229e431.html,,,,,, "A mixture of: tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium ((1-(4(or 5)-nitro-2-oxidophenylazo)-2-naphtholato)(1-(3-nitro-2-oxido-5-pentylphenylazo)-2-naphtholato))chromate(1-)",117527-94-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e263e7b-700e-4e11-9651-2291e34ef14e/documents/IUC5-f7ad4333-5860-4a8f-ac21-1847221c9cfa_2d605b7f-6daa-4398-bb61-e425a229e431.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "A mixture of: tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium ((1-(4(or 5)-nitro-2-oxidophenylazo)-2-naphtholato)(1-(3-nitro-2-oxido-5-pentylphenylazo)-2-naphtholato))chromate(1-)",117527-94-3,"The oral LD50 value in rat is > 5000 mg/kg bw (OECD 401, GLP).The dermal LD50 in rat is > 2000 mg/kg bw (OECD 402, GLP). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e263e7b-700e-4e11-9651-2291e34ef14e/documents/IUC5-26419fca-27a4-4358-ba01-2fe8d65d2a8b_2d605b7f-6daa-4398-bb61-e425a229e431.html,,,,,, "A mixture of: tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium ((1-(4(or 5)-nitro-2-oxidophenylazo)-2-naphtholato)(1-(3-nitro-2-oxido-5-pentylphenylazo)-2-naphtholato))chromate(1-)",117527-94-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e263e7b-700e-4e11-9651-2291e34ef14e/documents/IUC5-26419fca-27a4-4358-ba01-2fe8d65d2a8b_2d605b7f-6daa-4398-bb61-e425a229e431.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "A mixture of: tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium bis[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium [[1-[[5-(1,1-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-2-naphthalenolato(2-)]-[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphthalenolato(2-)]]-chromate(1-); tert-alkyl(C12-C14)ammonium ((1-(4(or 5)-nitro-2-oxidophenylazo)-2-naphtholato)(1-(3-nitro-2-oxido-5-pentylphenylazo)-2-naphtholato))chromate(1-)",117527-94-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e263e7b-700e-4e11-9651-2291e34ef14e/documents/IUC5-26419fca-27a4-4358-ba01-2fe8d65d2a8b_2d605b7f-6daa-4398-bb61-e425a229e431.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "A mixture of: thiobis(4,1-phenylene)-S,S,S',S'-tetraphenyldisulfonium bishexafluorophosphate; diphenyl(4-phenylthiophenyl)sulfonium hexafluorophosphate",74227-35-3,"The repeated dose toxicity was investigated following the OECD Guideline 409 (Repeated Dose 90-Day Oral Toxicity in Non-Rodents).Oral doses: 6.81, 21.5, 68.1, 215 mg/kg b.w. The high dosage was increased on the 38th treatment day from 215 to 464 mg/kg/day.This study was included in the Notification dossier of the first Notifier (1989); since under Directive 67/548/EEC the studies of the first notifier were not included in the dossier, Lamberti has the letter of Access, but not the complete study report. The study can be considered reliable since already evaluated by the Authority. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f242c42-04c3-4b53-abac-8294edd9ac93/documents/IUC5-2b9cbc86-0f5f-476c-a48c-3f29ef80c0d7_e9af63bb-0b4f-43a5-aa53-8d8c20a92544.html,,,,,, "A mixture of: thiobis(4,1-phenylene)-S,S,S',S'-tetraphenyldisulfonium bishexafluorophosphate; diphenyl(4-phenylthiophenyl)sulfonium hexafluorophosphate",74227-35-3,The acute oral and dermal toxicity was tested following the OECD Guideline 401 (Acute Oral Toxicity) and the OECD Guideline 402 and EU Method B.3(Acute Dermal Toxicity) respectively. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f242c42-04c3-4b53-abac-8294edd9ac93/documents/IUC5-126ad746-618d-4ea9-a7e5-b4ed4a2ec24f_e9af63bb-0b4f-43a5-aa53-8d8c20a92544.html,,,,,, "A mixture of: thiobis(4,1-phenylene)-S,S,S',S'-tetraphenyldisulfonium bishexafluorophosphate; diphenyl(4-phenylthiophenyl)sulfonium hexafluorophosphate",74227-35-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f242c42-04c3-4b53-abac-8294edd9ac93/documents/IUC5-126ad746-618d-4ea9-a7e5-b4ed4a2ec24f_e9af63bb-0b4f-43a5-aa53-8d8c20a92544.html,,oral,LD50,"5,110 mg/kg bw",, "A mixture of: thiobis(4,1-phenylene)-S,S,S',S'-tetraphenyldisulfonium bishexafluorophosphate; diphenyl(4-phenylthiophenyl)sulfonium hexafluorophosphate",74227-35-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f242c42-04c3-4b53-abac-8294edd9ac93/documents/IUC5-126ad746-618d-4ea9-a7e5-b4ed4a2ec24f_e9af63bb-0b4f-43a5-aa53-8d8c20a92544.html,,dermal,LD50,"2,000 mg/kg bw",, reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives,192268-65-8,NOAEL (OECD 408) = 50 mg/kg bw/d. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/77c88ed2-b13c-4656-a346-5ef78a76fe84/documents/c7e9ced9-8798-4c39-9daf-aaac83cb88f6_854f08c9-d4a0-4bd6-a40f-1b30e5809bb6.html,,,,,, reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives,192268-65-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/77c88ed2-b13c-4656-a346-5ef78a76fe84/documents/c7e9ced9-8798-4c39-9daf-aaac83cb88f6_854f08c9-d4a0-4bd6-a40f-1b30e5809bb6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives,192268-65-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/77c88ed2-b13c-4656-a346-5ef78a76fe84/documents/c7e9ced9-8798-4c39-9daf-aaac83cb88f6_854f08c9-d4a0-4bd6-a40f-1b30e5809bb6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives,192268-65-8,"LD50(oral, rat) > 2000 mg/kg LD50(dermal, rat) > 2000 mg/kg ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77c88ed2-b13c-4656-a346-5ef78a76fe84/documents/0d2805bf-d394-4970-99d0-fbb0582a2f4e_854f08c9-d4a0-4bd6-a40f-1b30e5809bb6.html,,,,,, reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives,192268-65-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77c88ed2-b13c-4656-a346-5ef78a76fe84/documents/0d2805bf-d394-4970-99d0-fbb0582a2f4e_854f08c9-d4a0-4bd6-a40f-1b30e5809bb6.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, reaction mass of: triphenylthiophosphate and tertiary butylated phenyl derivatives,192268-65-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77c88ed2-b13c-4656-a346-5ef78a76fe84/documents/0d2805bf-d394-4970-99d0-fbb0582a2f4e_854f08c9-d4a0-4bd6-a40f-1b30e5809bb6.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "A mixture of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy-1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate",115100-55-5," NOEL (oral, 28 d) = 50 mg/kg/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21fbaa5f-2921-438b-95d9-e528577c190a/documents/425dbf0d-ecb1-4721-9592-8f9fd3c7c377_f2a8df51-4183-4587-9765-16931c1122c9.html,,,,,, "A mixture of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy-1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate",115100-55-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21fbaa5f-2921-438b-95d9-e528577c190a/documents/425dbf0d-ecb1-4721-9592-8f9fd3c7c377_f2a8df51-4183-4587-9765-16931c1122c9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "A mixture of: trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-(4-nitro-2-sulfonatoanilino)phenylazo)phenolato)ferrate(1-); trisodium bis(2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(4-nitro-2-sulfonatophenylazo)phenolato)ferrate(1-); trisodium (2,4(or 2,6 or 4,6)-bis(3,5-dinitro-2-oxidophenylazo)-5-hydroxyphenolato)(2(or 4 or 6)-(3,5-dinitro-2-oxidophenylazo)-5-hydroxy-4(or 2 or 6)-(3-sulfonatophenylazo)phenolato)ferrate(1-); disodium 3,3'-(2,4-dihydroxy-1,3(or 1,5 or 3,5)-phenylenediazo)dibenzenesulfonate",115100-55-5," LD50 (oral, rat) > 5000 mg/kg bw LD50 (dermal, rat) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21fbaa5f-2921-438b-95d9-e528577c190a/documents/fa08a8bb-ffce-404a-90dc-340025c2a7ee_f2a8df51-4183-4587-9765-16931c1122c9.html,,,,,, "Acacia mearnsi, ext., reaction products with ammonium chloride and formaldehyde",85029-52-3,"Oral Route:A combined repeated dose toxicity study with the reproduction/ developmental toxicity screening has been conducted according to OECD 422 test guideline using the oral exposure route on wistar rats. No classification for repeat-dose toxicity is warranted based on the absence of toxicologically relevant effects in this study, according to the criteria of Annex VI Directive 67/748/EEC or the 1272/2008 regulation. Under the conditions of this study, no adverse systemic effects were observed and the No Observed Effect Level (NOEL) in males and females was considered to be 1000 mg/kg/day. Inhalation Route:Based on the available data and in accordance with section 1 of REACH Annex XI, the repeat dose toxicity study via the inhalation route does not need to be conducted if the study does not appear to be scientifically necessary.Dermal Route:Based on the available data and in accordance with section 1 of REACH Annex XI, the repeat dose toxicity study via the dermal route does not need to be conducted if the study does not appear to be scientifically necessary. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8be1134-2438-4db3-b34c-b4e8ffea0df6/documents/IUC5-9ad08164-8dd6-41bc-a12e-3b113bc39fd1_62c638b4-dd3d-496b-bffc-42b627a4a523.html,,,,,, "Acacia mearnsi, ext., reaction products with ammonium chloride and formaldehyde",85029-52-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8be1134-2438-4db3-b34c-b4e8ffea0df6/documents/IUC5-9ad08164-8dd6-41bc-a12e-3b113bc39fd1_62c638b4-dd3d-496b-bffc-42b627a4a523.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Acacia mearnsi, ext., reaction products with ammonium chloride and formaldehyde",85029-52-3,"Oral: In the two available studies (and reliable study), the LD50 was determined to be > 2000 mg/kg bw.Dermal: In the only available (and reliable study), the LD50 was determined to be > 2000 mg/kg bw.Therefore, the test substance has no acute toxicity regarding oral and dermal routes in the test conditions and should not be classified according to 1272/2008/EC regulation. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8be1134-2438-4db3-b34c-b4e8ffea0df6/documents/IUC5-922b14eb-572a-4c7b-906a-60b296097efe_62c638b4-dd3d-496b-bffc-42b627a4a523.html,,,,,, "Acacia mearnsi, ext., reaction products with ammonium chloride and formaldehyde",85029-52-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8be1134-2438-4db3-b34c-b4e8ffea0df6/documents/IUC5-922b14eb-572a-4c7b-906a-60b296097efe_62c638b4-dd3d-496b-bffc-42b627a4a523.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Acacia mearnsi, ext., reaction products with ammonium chloride and formaldehyde",85029-52-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8be1134-2438-4db3-b34c-b4e8ffea0df6/documents/IUC5-922b14eb-572a-4c7b-906a-60b296097efe_62c638b4-dd3d-496b-bffc-42b627a4a523.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Acetamide, N-(2,4-dinitrophenyl)-, reaction products with 1-methyl-2,4-dinitrobenzene and sodium sulfide (Na2(Sx)), leuco derivatives",85940-08-5, In an acute oral toxicity study in rats the acute oral LD50 was determined to be > 2000 mg/kg bw (corresponding to > 2660 mg product/kg bw). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81058007-6278-4fdb-a958-85661ff75f8b/documents/592604cb-c6dc-43a9-9985-b6e0ff7c46a7_619d667f-a6d6-4f09-b405-76ffdee873e2.html,,,,,, "Acetamide, N-(2,4-dinitrophenyl)-, reaction products with 1-methyl-2,4-dinitrobenzene and sodium sulfide (Na2(Sx)), leuco derivatives",85940-08-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81058007-6278-4fdb-a958-85661ff75f8b/documents/592604cb-c6dc-43a9-9985-b6e0ff7c46a7_619d667f-a6d6-4f09-b405-76ffdee873e2.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Acetamide, N-(2,4-dinitrophenyl)-, reaction products with p-phenylenediamine, sodium sulfide (Na2(Sx)) and sulfur, leuco deriv.",85940-09-6," Under the conditions of an OECD 422 compliant study, the test item (Leuco Sulphur Yellow 22, CAS 90268 -98 -7, source substance for read across to Olive BW) administered at 100, 300 or 1000 mg dye/kg bw/day (corresponding to doses of 110.46, 331.38 and 1104.61 mg test substance/kg bw/day by oral gavage did not cause signs of systemic toxicity and did not adversely influence the reproductive performance (gonad function, mating behavior, conception, parturition) in parental male and female Han:WIST rats. The development of the F1 offspring was not impaired from birth to post-natal day 13 at any dose level after repeated oral administration of dams. Based on these observations the No Observed Adverse Effect Levels (NOAEL) were determined as follows: NOAEL for systemic toxicity of male/female rats: 1000 mg/kg bw/day NOAEL for reproductive performance of male/ female rats: 1000 mg/kg bw/day NOAEL for F1 Offspring: 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51d6615f-efc7-4849-80f9-1e0d37f3a239/documents/4a7ae4f0-fee8-4916-aaa3-e7fa82d5e889_f8738299-67e3-492d-8b43-f088f9a7c7d9.html,,,,,, "Acetamide, N-(2,4-dinitrophenyl)-, reaction products with p-phenylenediamine, sodium sulfide (Na2(Sx)) and sulfur, leuco deriv.",85940-09-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51d6615f-efc7-4849-80f9-1e0d37f3a239/documents/4a7ae4f0-fee8-4916-aaa3-e7fa82d5e889_f8738299-67e3-492d-8b43-f088f9a7c7d9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Acetamide, N-(2,4-dinitrophenyl)-, reaction products with p-phenylenediamine, sodium sulfide (Na2(Sx)) and sulfur, leuco deriv.",85940-09-6, In an acute oral toxicity study in rats the acute oral LD50 was determined to be > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51d6615f-efc7-4849-80f9-1e0d37f3a239/documents/7f089bd6-0dbd-4432-9078-2772b1524043_f8738299-67e3-492d-8b43-f088f9a7c7d9.html,,,,,, "Acetamide, N-(2,4-dinitrophenyl)-, reaction products with p-phenylenediamine, sodium sulfide (Na2(Sx)) and sulfur, leuco deriv.",85940-09-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51d6615f-efc7-4849-80f9-1e0d37f3a239/documents/7f089bd6-0dbd-4432-9078-2772b1524043_f8738299-67e3-492d-8b43-f088f9a7c7d9.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N-(3',4'-dichloro-5-fluorobiphenyl-2-yl)acetamide",877179-03-8,"Acute toxicity: via oral route OECD TG 423, oral, LD50 > 2000 mg/kg body weight. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/574d267a-5841-44f7-bbbe-7d9c60773cc4/documents/5b2d48f6-0f92-4fd1-b179-a9d4d1e93428_345cd3f2-f5bb-44bb-90fe-04e604b95c18.html,,,,,, "N-(3',4'-dichloro-5-fluorobiphenyl-2-yl)acetamide",877179-03-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/574d267a-5841-44f7-bbbe-7d9c60773cc4/documents/5b2d48f6-0f92-4fd1-b179-a9d4d1e93428_345cd3f2-f5bb-44bb-90fe-04e604b95c18.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, N-(4-Fluorophenyl)-2-hydroxy-N-(1-methylethyl) acetamide,54041-17-7,"Acute oral toxicity, rat: The test substance is moderately toxic to rats following acute oral administration. Some of the signs that were observed occurred immediately after administration and continued until day 5 maximum. Essentially, the following signs were observed: impaired activity and dyspnea, lethargy, piloerection, spastic or staggering gait, lateral recumbency, increased salivation, atony, convulsions, spasmodic state, no reflexes. Mortalities occurred starting at a dose of 400 mg/kg body weight.  LD50: Rat male: 726 mg/kg body weight (approximate) LD50: Rat female: 474 mg/kg body weight (approximate)   Acute inhalation, rat: The test substanceexhibited a slight acute inhalation toxicity in rats. The death and the clinical signs of the animals are regarded as causally related to an irritant effect of the test substance on the respiratory tract. In addition to nonspecific effects to the central nervous systems, the rats exposed to the 6802 mg/m3 exhibited clear signs of an irritant effect: bradypnea and labored breathing including gasping, rales, serous nasal discharge, bloody incrustations around the nose, hypothermia and corneal opacity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b331ea04-1ffa-4f99-bf23-e1b5c73b0803/documents/fd5ad8ab-02eb-4da4-a745-11e4e397c102_d7ff9cf9-ce1e-42d6-99ae-5c7628ded235.html,,,,,, N-(4-Fluorophenyl)-2-hydroxy-N-(1-methylethyl) acetamide,54041-17-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b331ea04-1ffa-4f99-bf23-e1b5c73b0803/documents/fd5ad8ab-02eb-4da4-a745-11e4e397c102_d7ff9cf9-ce1e-42d6-99ae-5c7628ded235.html,,oral,LD50,474 mg/kg bw,adverse effect observed, N-(4-Fluorophenyl)-2-hydroxy-N-(1-methylethyl) acetamide,54041-17-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b331ea04-1ffa-4f99-bf23-e1b5c73b0803/documents/fd5ad8ab-02eb-4da4-a745-11e4e397c102_d7ff9cf9-ce1e-42d6-99ae-5c7628ded235.html,,inhalation,LC50,"6,800 mg/m3",adverse effect observed, "Acetic acid, (ethylenedinitrilo)tetra-, cobalt salt",24704-41-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa312636-08ed-4aa5-bea0-854267cbd768/documents/427b3c57-c890-44b9-9888-13c6761c3375_3f4c39d8-3f69-4bdc-a082-5c0ecb54e1b4.html,,oral,LD50,648.52 mg/kg bw,adverse effect observed, "Difluoro{[2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl]oxy}acetic acid",1190931-41-9,"The potential oral acute toxicity of F-DIOX acid was evaluated through the Read Across approach with cC6O4 ammonium salt.Basing on experimental study of acute oral toxicity performed on cC6O4 ammonium salt, F-DIOX acid would be classified according to the Regulation (EC) No. 1272/2008 as following:Acute oral toxicity - Category 4Hazard statement (Oral): H302: Harmful if swallowed ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cd6cbc8-31b7-4f21-8f41-b1fc943327c3/documents/IUC5-429ad425-e9b4-4a11-aaa6-a61be2d34d8c_f78f0fbf-a51c-42a5-9e5f-e04e29b2bd06.html,,,,,, "Acetic acid, 2,2-difluoro-2-((2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl)oxy)-, ammonium salt (1:1)",1190931-27-1,"Results of a TK study with combined 28-day treatment using a batch representative of the current production process (""new process""): - Key study: Subacute oral study in rats, OECD TG 407, GLP: male NOAEL >= 20 mg/kg bw/day ; female NOAEL >= 20 mg/kg bw/day. Minimal adaptative effects were observed on the liver, reversible after a 2-week recovery period. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/279a2ffb-728a-458d-acf3-683b74e002a1/documents/e94c18c8-0c97-4fcd-8375-d7c43910544b_c4d63f96-9f85-4236-9e89-d784d12a7bf3.html,,,,,, "Acetic acid, 2,2-difluoro-2-((2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl)oxy)-, ammonium salt (1:1)",1190931-27-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/279a2ffb-728a-458d-acf3-683b74e002a1/documents/e94c18c8-0c97-4fcd-8375-d7c43910544b_c4d63f96-9f85-4236-9e89-d784d12a7bf3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,>= 20 mg/kg bw/day,,rat "Acetic acid, 2,2-difluoro-2-((2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl)oxy)-, ammonium salt (1:1)",1190931-27-1,Two acute toxicity studies conducted in rats in compliance with GLP and according to testing standards are available on cC6O4 ammonium salt (old process) with the following results: - an oral toxicity study according to OECD guideline 423 and EU method B.1 : 300 < rat LD50 < 2000 mg/kg - a dermal toxicity study according to OECD guideline 402 and EU method B.3 : rat LD50 > 2000 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/279a2ffb-728a-458d-acf3-683b74e002a1/documents/IUC5-0e46c7e0-1d62-47e0-8383-d9361e102005_c4d63f96-9f85-4236-9e89-d784d12a7bf3.html,,,,,, "Acetic acid, 2,2-difluoro-2-((2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl)oxy)-, ammonium salt (1:1)",1190931-27-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/279a2ffb-728a-458d-acf3-683b74e002a1/documents/IUC5-0e46c7e0-1d62-47e0-8383-d9361e102005_c4d63f96-9f85-4236-9e89-d784d12a7bf3.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, "Acetic acid, 2,2-difluoro-2-((2,2,4,5-tetrafluoro-5-(trifluoromethoxy)-1,3-dioxolan-4-yl)oxy)-, ammonium salt (1:1)",1190931-27-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/279a2ffb-728a-458d-acf3-683b74e002a1/documents/IUC5-0e46c7e0-1d62-47e0-8383-d9361e102005_c4d63f96-9f85-4236-9e89-d784d12a7bf3.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 2-[(5-chloro-8-quinolinyl)oxy]acetic acid,88349-88-6," The NOAEL for repeated dose oral toxicity in rats was the highest dose tested, 2100 ppm, which corresponded to time-weighted average concentrations of 116.0 and 127.0 mg/kg bw/day in males and females, respectively. On this basis, low toxicity is also predicted for the inhalation and dermal routes of exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37bb2ce3-725c-4058-b04e-f1aee78451a2/documents/bce9b117-5b37-4b90-b0da-e6e50e6f222d_bae9822c-8a1b-4f6f-bdfb-3e90f1f2e7cf.html,,,,,, 2-[(5-chloro-8-quinolinyl)oxy]acetic acid,88349-88-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37bb2ce3-725c-4058-b04e-f1aee78451a2/documents/bce9b117-5b37-4b90-b0da-e6e50e6f222d_bae9822c-8a1b-4f6f-bdfb-3e90f1f2e7cf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,116 mg/kg bw/day,,rat 2-[(5-chloro-8-quinolinyl)oxy]acetic acid,88349-88-6," Cloquintocet acid is of low acute oral, inhalation and dermal toxicity. The acute oral LD50 in the rat is >2000 mg/kg bw. The acute 4-hour inhalation LC50 in the rat is >6.11 mg/L. The acute dermal LD50 in the rat is >5000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37bb2ce3-725c-4058-b04e-f1aee78451a2/documents/031d9f55-fc5b-4655-ae31-31458f950f3f_bae9822c-8a1b-4f6f-bdfb-3e90f1f2e7cf.html,,,,,, 2-[(5-chloro-8-quinolinyl)oxy]acetic acid,88349-88-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37bb2ce3-725c-4058-b04e-f1aee78451a2/documents/031d9f55-fc5b-4655-ae31-31458f950f3f_bae9822c-8a1b-4f6f-bdfb-3e90f1f2e7cf.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-[(5-chloro-8-quinolinyl)oxy]acetic acid,88349-88-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37bb2ce3-725c-4058-b04e-f1aee78451a2/documents/031d9f55-fc5b-4655-ae31-31458f950f3f_bae9822c-8a1b-4f6f-bdfb-3e90f1f2e7cf.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, 2-[(5-chloro-8-quinolinyl)oxy]acetic acid,88349-88-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37bb2ce3-725c-4058-b04e-f1aee78451a2/documents/031d9f55-fc5b-4655-ae31-31458f950f3f_bae9822c-8a1b-4f6f-bdfb-3e90f1f2e7cf.html,,inhalation,LC50,"6,110 mg/m3",no adverse effect observed, heptan-2-yl [(5-chloroquinolin-8-yl)oxy]acetate,99607-70-2,"Oral, repeated dose toxicity, chronic: NOAEL = 4.33 mg/kg bw/day (rat, feeding study, OECD 451, Fankhauser 1992) Inhalation, repeated dose toxicity: no data available Dermal, repeated dose toxicity, sub-acute: NOAEL = 1000 mg/kg bw/day (rat, OECD 410, Schneider 1988) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): One fully reliable GLP study available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Fully reliable studies on the sub-chronic and chronic repeated dose toxicity of cloquintocet-mexyl to rats via the oral route are available, which are selected as key studies. Additional supporting studies in mice and rats are also available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60a30ac6-b083-4900-b867-664bb02f83bd/documents/IUC5-97d31465-38dd-4c3d-a31c-d151714a7bad_bfc067f2-02a7-4b89-adc0-f6d33f671e95.html,,,,,, heptan-2-yl [(5-chloroquinolin-8-yl)oxy]acetate,99607-70-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60a30ac6-b083-4900-b867-664bb02f83bd/documents/IUC5-97d31465-38dd-4c3d-a31c-d151714a7bad_bfc067f2-02a7-4b89-adc0-f6d33f671e95.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat heptan-2-yl [(5-chloroquinolin-8-yl)oxy]acetate,99607-70-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60a30ac6-b083-4900-b867-664bb02f83bd/documents/IUC5-97d31465-38dd-4c3d-a31c-d151714a7bad_bfc067f2-02a7-4b89-adc0-f6d33f671e95.html,Chronic toxicity – systemic effects,oral,NOAEL,4.33 mg/kg bw/day,,rat heptan-2-yl [(5-chloroquinolin-8-yl)oxy]acetate,99607-70-2," Oral LD50 >5000 mg/kg bw (rats, OECD TG 401) Dermal LD50 >2000 mg/kg bw (rats, OECD TG 402) Inhalation LC50 >935 mg/L (rabbits, OECD TG 403) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60a30ac6-b083-4900-b867-664bb02f83bd/documents/IUC5-70199421-93a5-4ea8-8c88-5be14728cff0_bfc067f2-02a7-4b89-adc0-f6d33f671e95.html,,,,,, heptan-2-yl [(5-chloroquinolin-8-yl)oxy]acetate,99607-70-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60a30ac6-b083-4900-b867-664bb02f83bd/documents/IUC5-70199421-93a5-4ea8-8c88-5be14728cff0_bfc067f2-02a7-4b89-adc0-f6d33f671e95.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, heptan-2-yl [(5-chloroquinolin-8-yl)oxy]acetate,99607-70-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60a30ac6-b083-4900-b867-664bb02f83bd/documents/IUC5-70199421-93a5-4ea8-8c88-5be14728cff0_bfc067f2-02a7-4b89-adc0-f6d33f671e95.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, heptan-2-yl [(5-chloroquinolin-8-yl)oxy]acetate,99607-70-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60a30ac6-b083-4900-b867-664bb02f83bd/documents/IUC5-70199421-93a5-4ea8-8c88-5be14728cff0_bfc067f2-02a7-4b89-adc0-f6d33f671e95.html,,inhalation,discriminating conc.,935 mg/m3,adverse effect observed, Pentaerythritoltetracyanoacetic ester,178671-69-7,The median lethal dose of the test substance after oral application was found to exceed 2000 mg/kg body weight for male and female animals. No mortalities occured and no signs of toxicity were noted. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8008482-3695-4bad-a2b3-65f71fbdd28e/documents/IUC5-036d0f82-1517-439e-ac38-ee50991e1529_7cf0badd-adef-4547-9a9f-3f9069d49cca.html,,,,,, Pentaerythritoltetracyanoacetic ester,178671-69-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8008482-3695-4bad-a2b3-65f71fbdd28e/documents/IUC5-036d0f82-1517-439e-ac38-ee50991e1529_7cf0badd-adef-4547-9a9f-3f9069d49cca.html,,oral,LD50,"2,000 mg/kg bw",, "Acetic acid, 2-oxo-, reaction products with ethylenediamine, iron chloride (FeCl3) and phenol, potassium salts",2088841-41-0," In a 90 -day oral (gavage) key repeated dose toxicity study with FeEDDHMA in rats (Schoenmakers, 1996; see also read across document in section 13), the NOEL was established at 20 mg/kg bw/day in male rats and at 100 mg/kg bw/day in female rats. In this study, treatment with the test item resulted in slight haematological changes and a slightly increased relative liver weight in male rats treated at 100 mg/kg bw/day. The slight increase in relative kidney weight was, however, not corroborated by histopathological renal effects, and was not seen in female rats at this level. Histopathological kidney effects were observed in both male and female rats at the next higher level of 500 mg/kg bw. In addition, two oral 28-day studies were available. The NOAEL in one of these oral 4 -week studies (Banks, 1988) was 200 mg/kg bw; in the second oral 4 -week study (Korn, 1990) 200 mg/kg bw was a LOAEL, however, the only change observed at that level consisted of slight fatty degenerations of renal tubular epithelial cells; no increase in relative kidney weight was observed at that level. The subchronic toxicity of FeNaEDDHA by the oral route was investigated in rats (Novartis Crop Protection AG, 1998). The test item FeNaEDDHA was administered to 10 Sprague-Dawley derived rats/sex/dose level by oral gavage at 5, 50 or 200 mg/kg bw/day for 90 days. A concurrent control group was treated with the vehicle only. Additional 10 animals/sex of the high dose and control group were kept on control diet for a 4 -week recovery period before sacrifice. Treatment with the test item resulted in lower food intake and impared body weight development at 200 mg/kg bw/day. Reversible effects on red blood cell (normochromic anaemia) and white blood cell parameters, and higher values of platelets and prothrombin activity were noted at 50 and/or 200 mg/kg bw/day. In addition, changes of blood chemistry and urine parameters concerning the liver and kidneys were noted. The body weight relative heart weight was increased in males at 200 mg/kg bw/day. Under the conditions of this study, the NOAEL for FeNaEDDHA when administered by daily oral gavage for three months was 10 mg/kg bw/day (estimated from the LOAEL). In a repeated dose dermal toxicity study (CIBA-GEIGY Limited, 1996b), FeNaEDDHA was administered to the skin of 5 Sprague-Dawley derived rats/sex/dose level at 10, 100 or 1000 mg/kg bw/day for 28 days (5 days/week). A concurrent control group was treated with the vehicle only. Dermal treatment with the test item resulted in no mortality, no relevant clinical signs, no changes in food consumption, no effects on haematology and clinical chemistry parameters and no gross findings. A transient slight body weight loss was noted in females at 1000 mg/kg bw/day during the first week of treatment. There was an increase in adrenal weight in males at 1000 mg/kg bw/day. Microscopically, the skin application sites of females at 1000 mg/kg bw/day revealed epidermal hyperkeratosis associated with an increased severity of acanthosis. In 2/5 males at 1000 mg/kg bw/day centrilobular hypertrophy of hepatocytes was noted. Based on the slight effects on the liver and skin and due to the increased adrenal weight noted at 1000 mg/kg bw/day, the NOEL was established at 100 mg/kg bw/day. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cae3d89d-6b5f-4299-b26e-77b864ba1833/documents/ef78b109-08af-4372-a90d-ab147ea1e608_90e54813-007e-43d1-9ccc-d7592e104112.html,,,,,, "Acetic acid, 2-oxo-, reaction products with ethylenediamine, iron chloride (FeCl3) and phenol, potassium salts",2088841-41-0, Several studies available ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cae3d89d-6b5f-4299-b26e-77b864ba1833/documents/94dbdd2b-a840-4692-a93d-d6f60f366230_90e54813-007e-43d1-9ccc-d7592e104112.html,,,,,, "Reaction products of acetic anhydride and 1,5,10-trimethyl-1,5,9-cyclodecatriene",144020-22-4,"Under the conditions of the test (OECD TG 422, GLP), the NOAEL was determined to be 150 mg/kg bw/day for males and females, based on the increase of liver weights effect. Under the conditions of the test (OECD TG 407, GLP), the NOAEL was determined to be 150 mg/kg bw/day for males and females, based on haematological, biochemical, organ weight and histopathological effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ad7385b-f6fa-46b8-940a-b3eae90fce46/documents/bfa68dc8-0cdf-4b5d-8140-71718c3aa822_64a4b2de-43a3-4269-b280-34240365ea31.html,,,,,, "Reaction products of acetic anhydride and 1,5,10-trimethyl-1,5,9-cyclodecatriene",144020-22-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ad7385b-f6fa-46b8-940a-b3eae90fce46/documents/bfa68dc8-0cdf-4b5d-8140-71718c3aa822_64a4b2de-43a3-4269-b280-34240365ea31.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Reaction products of acetic anhydride and 1,5,10-trimethyl-1,5,9-cyclodecatriene",144020-22-4,"Acute oral toxicity: LD50 is >5000 mg/kg bw in an OECD TG 401 Acute inhalation toxicity: LC50 is >26000 mg/m3 which is derived from the acute oral LD50 using route to route extrapolation. Acute dermal toxicity: LD50 is >2000 mg/kg bw in an OECD TG 402 Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The selected study is the key (and only) study and is adequate to cover this endpoint Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The selected study is the key (and only) study and is adequate to cover this endpoint ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ad7385b-f6fa-46b8-940a-b3eae90fce46/documents/56b87174-dc82-493a-97e4-dd9a338ff7a5_64a4b2de-43a3-4269-b280-34240365ea31.html,,,,,, "Acetic acid, C11-14-branched alkyl esters, C13-Rich",108419-35-8,"In an acute oral toxicity study in mail and female Sprague-Dawley rats with the test substance,no deaths or adverse clinical signs were noted. There were no adverse necropsy findings.  The acute oral LD 50 value was found to be greater than 5000 mg/kg bw.  In an acute dermal toxicity study in mail and female New Zeland White rabbits with the test substance, no deaths were noted during the obsrvation period.  During necropspsy, it revealed liver and salivary gland discoloration in 1 animal; kidney discoloration and spleen enlargement in 1 animal and alopecia in 1 animal.  The acute dermal LD 50 value was found to be greater thn 3150 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The key result is based on the guideline study conducted in rabbits. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c6c25a4-005f-438d-9445-43d7591de19f/documents/f7f98643-c5f0-45f1-9565-b1e4f412df54_cb3576b7-76bd-4315-9139-466eb8c7c962.html,,,,,, "Acetic acid, C11-14-branched alkyl esters, C13-Rich",108419-35-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c6c25a4-005f-438d-9445-43d7591de19f/documents/f7f98643-c5f0-45f1-9565-b1e4f412df54_cb3576b7-76bd-4315-9139-466eb8c7c962.html,,oral,LD50,"3,160 mg/kg bw",no adverse effect observed, "Acetic acid, C11-14-branched alkyl esters, C13-Rich",108419-35-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c6c25a4-005f-438d-9445-43d7591de19f/documents/f7f98643-c5f0-45f1-9565-b1e4f412df54_cb3576b7-76bd-4315-9139-466eb8c7c962.html,,dermal,LD50,"3,160 mg/kg bw",no adverse effect observed, "Acetic acid, C11-14-isoalkyl esters, C13-rich",84712-50-5," In the key acute oral toxicity study in rats, conducted according to a protocol similar to OECD TG 401 and in compliance with GLP, the reported LD50 value was greater than 5000 mg/kg bw (Biosearch, 1979). In the key acute dermal toxicity study in rats, conducted according to a protocol similar to OECD TG 402 and in compliance with GLP, the reported LD50 value was greater than 2000 mg/kg bw (Biosearch, 1979). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ece72c16-5cea-4772-8a15-e9af21476a40/documents/1c665208-279a-4a31-8a13-7584278e32fc_41241c2f-2934-46ab-b58b-16d81c7cd106.html,,,,,, "Acetic acid, C11-14-isoalkyl esters, C13-rich",84712-50-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ece72c16-5cea-4772-8a15-e9af21476a40/documents/1c665208-279a-4a31-8a13-7584278e32fc_41241c2f-2934-46ab-b58b-16d81c7cd106.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Acetic acid, C11-14-isoalkyl esters, C13-rich",84712-50-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ece72c16-5cea-4772-8a15-e9af21476a40/documents/1c665208-279a-4a31-8a13-7584278e32fc_41241c2f-2934-46ab-b58b-16d81c7cd106.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Acetic acid, chloro-, sodium salt, reaction products with 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol and sodium hydroxide",68608-66-2,"The data for repeated dose toxicity are read across from a substance analogue. A reliable 90-day repeated dose oral toxicity study (performed according to OECD test guidelines and GLP principles) with rats was performed with a substance analogue, Amphoacetates C12-C14. The NOAEL was determined to be at least 1000 mg/kg bw/day in absence of any adverse effects. The rationale to read across the data is attached in Section 13. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study was performed with a substance analogue, according to OECD/EC guidance and GLP principles (Klimisch 1 study). The rationale to read across the data is attached in Section 13. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75b97f50-f6bd-46bc-b53a-6d6136d47351/documents/0b3611ce-b084-441a-8d2f-d6c651602e04_d336673e-02cd-4855-be27-98d90bd257bd.html,,,,,, "Acetic acid, chloro-, sodium salt, reaction products with 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol and sodium hydroxide",68608-66-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75b97f50-f6bd-46bc-b53a-6d6136d47351/documents/0b3611ce-b084-441a-8d2f-d6c651602e04_d336673e-02cd-4855-be27-98d90bd257bd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Acetic acid, chloro-, sodium salt, reaction products with 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol and sodium hydroxide",68608-66-2," Several acute oral toxicity studies are available. In the key study, conducted equivalent to OECD 401, the LD50 in rats was determined to be 3422 mg/kg (based on solid content). An acute dermal toxicity study conducted with a substance analogue in accordance with OECD 402 and according to GLP principles was considered appropriate to determine the acute dermal toxicity of the substance. The acute dermal toxicity was determined to be above 2612 mg/kg in a limit test. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75b97f50-f6bd-46bc-b53a-6d6136d47351/documents/2dcc78bb-5830-4143-9923-b8d76c4647e5_d336673e-02cd-4855-be27-98d90bd257bd.html,,,,,, "Acetic acid, chloro-, sodium salt, reaction products with 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol and sodium hydroxide",68608-66-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75b97f50-f6bd-46bc-b53a-6d6136d47351/documents/2dcc78bb-5830-4143-9923-b8d76c4647e5_d336673e-02cd-4855-be27-98d90bd257bd.html,,oral,LD50,"3,422 mg/kg bw",no adverse effect observed, "Acetic acid, chloro-, sodium salt, reaction products with 4,5-dihydro-2-undecyl-1H-imidazole-1-ethanol and sodium hydroxide",68608-66-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75b97f50-f6bd-46bc-b53a-6d6136d47351/documents/2dcc78bb-5830-4143-9923-b8d76c4647e5_d336673e-02cd-4855-be27-98d90bd257bd.html,,dermal,LD50,"2,612 mg/kg bw",no adverse effect observed, "Acetic acid, chromium salt, basic",39430-51-8,"NOAEL (90-d oral, rat) >= 2015 mg/kg bw/dayNOAEL (90-d oral, mouse) >= 4342 mg/kg bw/dayLOAEC, local (90-d, inhalation, rat) = 21 mg/m³NOAEC, systemic (90-d, inhalation, rat) = 210 mg/m³NOAEL, dermal, systemic (extrapolation from 90-d oral rat) >= 2015 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5fcef696-539f-4cd3-87ad-81ac62683082/documents/IUC5-e20e538e-70f3-43cd-834d-3e3b57e6db12_01bc8b41-ddf2-4b78-aecb-cd35dd2cdcf7.html,,,,,, "Acetic acid, chromium salt, basic",39430-51-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5fcef696-539f-4cd3-87ad-81ac62683082/documents/IUC5-e20e538e-70f3-43cd-834d-3e3b57e6db12_01bc8b41-ddf2-4b78-aecb-cd35dd2cdcf7.html,Repeated dose toxicity – local effects,inhalation,LOAEC,21 mg/m3,adverse effect observed,rat "Acetic acid, chromium salt, basic",39430-51-8,"LD50 (oral, rat) > 5000 mg/kg bwLD50 (dermal, rat) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fcef696-539f-4cd3-87ad-81ac62683082/documents/IUC5-925b6e82-52c5-4b38-b4e8-959b7356fca4_01bc8b41-ddf2-4b78-aecb-cd35dd2cdcf7.html,,,,,, "Acetic acid, oxo-, sodium salt, reaction products with cresol and ethylenediamine, iron sodium salts",84539-53-7,"Three repeated oral toxicity studies are available: one 90-day study and two 28-day studies. The kidney was considered to be the target organ, and some effects were seen on haematology parameters. In a key subacute 28-day dermal toxicity study with the structurally related substance EDDHA-Fe (CIBA-GEIGY Limited, 1996b), the NOEL was established at 100 mg/kg bw/day based on slight effects on the liver and skin and due to increased adrenal weight noted at the high dose level of 1000 mg/kg bw/day. No data on repeated inhalation exposure are required. Exposure by the inhalation route is considered to be negligible. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5fb6058-e107-4f6f-af7e-a984c53f2f07/documents/IUC5-46f52a81-c997-42a8-9c30-8e6444b93666_4719a22c-8e44-4faa-8976-af4d225d94e0.html,,,,,, "Acetic acid, oxo-, sodium salt, reaction products with cresol and ethylenediamine, iron sodium salts",84539-53-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5fb6058-e107-4f6f-af7e-a984c53f2f07/documents/IUC5-46f52a81-c997-42a8-9c30-8e6444b93666_4719a22c-8e44-4faa-8976-af4d225d94e0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Acetic acid, oxo-, sodium salt, reaction products with cresol and ethylenediamine, iron sodium salts",84539-53-7,The LD50 value derived from the acute oral toxicity study with EDDHMA-Fe is > 5000 mg/kg bw. The dermal LD50 is > 2000 mg/kg bw. The inhalation (4h) LC50 is > 1.24 mg/L air (maximally attainable concentration). ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5fb6058-e107-4f6f-af7e-a984c53f2f07/documents/IUC5-0fd42888-58f8-4edc-8dbf-0a17e2021994_4719a22c-8e44-4faa-8976-af4d225d94e0.html,,,,,, "Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and hydroxybenzenesulfonic acid monosodium salt, iron sodium salts",84539-54-8,"In a 28-day oral (gavage) key repeated dose toxicity study in rats conducted with the nearest analogue Fe(3K)EDDHSA, the NOEL was established at 1000 mg/kg bw/day, the highest dose level tested. No treatment- related effects were observed in animals in any parameter tested. In a key subacute 28-day dermal toxicity study conducted with another closely related substance Fe(Na)EDDHA, the NOEL was established at 100 mg/kg bw/day based on slight effects on the liver and skin and due to increased adrenal weight noted at the high dose level of 1000 mg/kg bw/day. No data on repeated inhalation exposure are required. Exposure by the inhalation route is considered to be negligible. The target substance Fe(3Na)EDDHSA does not need to be classified for systemic organ toxicity after repeated exposures. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1735c7ee-bd6d-4431-8bbe-32a37c635399/documents/IUC5-39e886b5-215f-43d4-89d7-6ebd0af05487_14ba9704-9943-48ba-9234-885551737e62.html,,,,,, "Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and hydroxybenzenesulfonic acid monosodium salt, iron sodium salts",84539-54-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1735c7ee-bd6d-4431-8bbe-32a37c635399/documents/IUC5-39e886b5-215f-43d4-89d7-6ebd0af05487_14ba9704-9943-48ba-9234-885551737e62.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and hydroxybenzenesulfonic acid monosodium salt, iron sodium salts",84539-54-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1735c7ee-bd6d-4431-8bbe-32a37c635399/documents/IUC5-39e886b5-215f-43d4-89d7-6ebd0af05487_14ba9704-9943-48ba-9234-885551737e62.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,,rat "Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and hydroxybenzenesulfonic acid monosodium salt, iron sodium salts",84539-54-8,"The LD50 values derived from the acute oral toxicity studies with the analogues substances Fe(3K)EDDHSA and Fe(Na)EDDHA were > 2000 mg/kg bw. The dermal LD50 of > 2000 mg/kg bw is established for both read-across substances, too. The inhalation (4h) LC50 is > 4200 mg/m³ air (maximum attainable concentration) is established for Fe(Na)EDDHA in a limit test. Based on these results, the target substance Fe(3Na)EDDHSA is considered to be not acutely toxic by all routes of exposure and does not need to be classified and labelled according to CLP. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1735c7ee-bd6d-4431-8bbe-32a37c635399/documents/IUC5-0f31d33b-dccc-4904-817f-d6f84bb2f00b_14ba9704-9943-48ba-9234-885551737e62.html,,,,,, "Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and hydroxybenzenesulfonic acid monosodium salt, iron sodium salts",84539-54-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1735c7ee-bd6d-4431-8bbe-32a37c635399/documents/IUC5-0f31d33b-dccc-4904-817f-d6f84bb2f00b_14ba9704-9943-48ba-9234-885551737e62.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and hydroxybenzenesulfonic acid monosodium salt, iron sodium salts",84539-54-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1735c7ee-bd6d-4431-8bbe-32a37c635399/documents/IUC5-0f31d33b-dccc-4904-817f-d6f84bb2f00b_14ba9704-9943-48ba-9234-885551737e62.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and hydroxybenzenesulfonic acid monosodium salt, iron sodium salts",84539-54-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1735c7ee-bd6d-4431-8bbe-32a37c635399/documents/IUC5-0f31d33b-dccc-4904-817f-d6f84bb2f00b_14ba9704-9943-48ba-9234-885551737e62.html,,inhalation,LC50,"4,200 mg/m3",no adverse effect observed, "Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts",84539-55-9,"In a 90-day oral (gavage) key repeated dose toxicity study in rats (Novartis Crop Protection AG, 1998), the NOAEL was established at 10 mg/kg bw/day based on a transient normochromic anaemia present at higher dose levels (estimated from LOAEL). Changes in clinical laboratory parameters noted at higher dose levels and indicative of effects on kidneys and/or liver were without microscopic correlate under the conditions of this study. A supporting and preceding 28-day dose range finding (oral gavage) study (CIBA-GEIGY Limited, 1996a) in rats provided further indication that the haematopoietic system and, at higher dose levels, the kidney represented target organs following repeated oral exposure. In a recently performed extended oral OECD 422 study with a pre-mating period of 10 weeks (therefore a total duration of at least 90 days), and in which all recent 90-day (OECD 408) study parameters have been included did not show parental toxicity at a level of 25 mg/kg bw/day. Mortality was observed at higher doses, and histopathological evaluation of the deceased or prematurely killed animals showed renal tubular degeneration and necrosis, hepatocellular degeneration and necrosis with and without hemorrhage, increased pigmented macrophages within splenic red pulp and medullary sinuses of mesenteric lymph nodes (draining lymph nodes of the intestinal tract), decreased lymphoid tissue of the thymus (atrophy), and compensatory responses within bone marrow of progenitor cells. Minimally increased numbers of pigmented macrophages within medullary sinuses of mesenteric lymph nodes and splenic red pulp, as well as an increased or decreased myeloid to erythroid ratio within sternal bone marrow were also seen in a few surviving animals at the mid and high dose. These findings together suggest increased red blood cell turnover in the affected animals and a compensatory response by bone marrow.  In a key subacute 28-day dermal toxicity study (CIBA-GEIGY Limited, 1996b), the NOEL was established at 100 mg/kg bw/day based on slight effects on the liver and skin and due to increased adrenal weight noted at the high dose level of 1000 mg/kg bw/day. Exposure by the inhalation route is considered negligible.        ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78c4235e-d5b4-415c-adda-d1f13242aea7/documents/447a214a-4932-432a-a97e-22d659955965_892a029d-dd0c-4859-939c-c44b1e4984bf.html,,,,,, "Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts",84539-55-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78c4235e-d5b4-415c-adda-d1f13242aea7/documents/447a214a-4932-432a-a97e-22d659955965_892a029d-dd0c-4859-939c-c44b1e4984bf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat "Acetic acid, oxo-, sodium salt, reaction products with ethylenediamine and phenol, iron sodium salts",84539-55-9,The LD50 value derived from the acute oral toxicity study with Fe-EDDHA is > 2000 mg/kg bw. The dermal LD50 is also > 2000 mg/kg bw. The inhalation 4-h LC50 is > 4200 mg/m³ air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78c4235e-d5b4-415c-adda-d1f13242aea7/documents/74f004b2-8ec6-424c-8f01-8f12dcd3b1e2_892a029d-dd0c-4859-939c-c44b1e4984bf.html,,,,,, Acetic anhydride,108-24-7,"Local irritation/corrosion effects at the site of first contact (eyes and respiratory system) are the effects of concern for acetic anhydride. A clear NOAEC of 1 ppm (4.18 mg/m3) was established in a guideline 13-week study (HRC, 1996).The weight of evidence indicates that acetic acid will be very rapidly and extensively formed in vivo following exposure to acetic anhydride. There is sufficient evidence from animal and human investigations with acetic acid, and from human studies on acetate intake and removal to conclude that systemic toxicity following exposure to acetic anhydride, at concentrations below those inducing local toxicity, is extremely unlikely. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a450d74-b205-49bc-95b3-63d350c307b5/documents/IUC5-d9d18d96-c7d9-4e18-8d60-bf42e1f1ab4c_fdc6fa80-efa7-4acc-9f5e-208d61256910.html,,,,,, Acetic anhydride,108-24-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a450d74-b205-49bc-95b3-63d350c307b5/documents/IUC5-d9d18d96-c7d9-4e18-8d60-bf42e1f1ab4c_fdc6fa80-efa7-4acc-9f5e-208d61256910.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4.2 mg/m3,adverse effect observed,rat Acetic anhydride,108-24-7,"Local effects at the site of first entry dominate the acute oral and inhalation toxicity profiles of acetic anhydride. Following inhalation exposure, severe irritation of the respiratory tract has been reported, with oral administration ulceration of the stomach. Although there is little quantitative information available on the acute effects of a single exposure to acetic anhydride in humans, there is evidence from accidental exposure that, qualitatively, similar effects are likely to occur in humans. A dermal acute toxicity study with acetic anhydride in rabbits reported low toxicity by this route of exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a450d74-b205-49bc-95b3-63d350c307b5/documents/IUC5-7cb7b5c3-2ebd-4e65-9a2f-43f5952adb93_fdc6fa80-efa7-4acc-9f5e-208d61256910.html,,,,,, Acetic anhydride,108-24-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a450d74-b205-49bc-95b3-63d350c307b5/documents/IUC5-7cb7b5c3-2ebd-4e65-9a2f-43f5952adb93_fdc6fa80-efa7-4acc-9f5e-208d61256910.html,,oral,LD50,630 mg/kg bw,adverse effect observed, Acetic anhydride,108-24-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a450d74-b205-49bc-95b3-63d350c307b5/documents/IUC5-7cb7b5c3-2ebd-4e65-9a2f-43f5952adb93_fdc6fa80-efa7-4acc-9f5e-208d61256910.html,,inhalation,LC50,"1,670 mg/m3",adverse effect observed, Acetoacetamide,5977-14-0," No adverse effects were found on male and female clinical observations, functional observations, body weight, food consumption, haematology and coagulation, clinical biochemistry, urinalysis and gross pathological findings at necropsy. There were also no test item-related effects on estrous cyclicity, nipple retention, anogenital distance, precoital interval and duration of gestation, reproductive indices, pup thyroid weight and pup thyroxine hormone, pup external findings on PND 0 and at death. No test item-related effects on number of corpora lutea, implantation sites, % pre and post implantation loss, litter data, litter weights, reproductive indices and number of live pups on PND 0, 4 and 13 in HD group were observed when compared with controls. Adverse effects of Acetoacetmide were noted at a dose level of 100 mg/kg body weight/day for general systemic toxicity (in terms of histopathological findings in thyroid and liver in parental males and females at 300 and 1000 mg/kg). Thus, the NOAEL for general systemic toxicity could be established at 100 mg/kg body weight/day. No adverse effects of Acetoacetmide were noted at a dose level of 1000 mg/kg body weight/day for reproductive and developmental toxicity. Thus, the NOAEL for reproductive and developmental toxicity screening could be established at 1000 mg/kg body weight/day.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8724681f-86c0-4dcd-bf88-758cb88707bd/documents/84b47acc-f12d-432c-b38b-72935d06982c_9e1be6ad-081b-4921-bfe8-e4ed1d2af284.html,,,,,, Acetoacetamide,5977-14-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8724681f-86c0-4dcd-bf88-758cb88707bd/documents/84b47acc-f12d-432c-b38b-72935d06982c_9e1be6ad-081b-4921-bfe8-e4ed1d2af284.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Acetoacetamide,5977-14-0, The acute oral toxicity of the test item was determined by application of 15000 mg/kg bw as a 25% solution in water to 10 female Wistar rats. After application animals showed tumbling gait and prone position. During the observation period of 14 days body weight gain was not affected and no deaths occured. Necropsy revealed no abnormal findings. The LD50 was determined to be >15000 mg/kg bw. Calculated for the pure substance: LD50 = 3750 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8724681f-86c0-4dcd-bf88-758cb88707bd/documents/20ee0d92-9d62-4c1e-a86e-7310c3c7094a_9e1be6ad-081b-4921-bfe8-e4ed1d2af284.html,,,,,, Acetoacetanilide,102-01-2,28-day oral toxicity (NONKEY_407_1991_Lonza_LZA 46/901159): symptoms of haematotoxicity ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a0d0cdd-5445-4599-83da-d9173ac86de6/documents/IUC5-4a706052-180a-4b15-92c7-038b066f63de_b7dcb215-d586-4ae5-97e7-3f4347f03b67.html,,,,,, Acetoacetanilide,102-01-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a0d0cdd-5445-4599-83da-d9173ac86de6/documents/IUC5-4a706052-180a-4b15-92c7-038b066f63de_b7dcb215-d586-4ae5-97e7-3f4347f03b67.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,12 mg/kg bw/day,,rat Acetoacetanilide,102-01-2,"LD50 values:acute orla toxicity rat (KEY_401_1975_Lonza_ 1975-11-25) female: 5400, male: 6500 mg/kg bwacute orla toxicity rat (NONKEY_401_1965_Hoechst_1965-11-30) female: 2450 mg/kg bwacute orla toxicity cat (NONKEY_MetHb_1978_Hoechst_487/78) female: >100 mg/kg bwacute orla toxicity cat (NONKEY_MetHb_1965_Hoechst_1965-11-30) male: >100, <=500 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a0d0cdd-5445-4599-83da-d9173ac86de6/documents/IUC5-05bbc003-f188-4626-82f6-7ce8482e2ee2_b7dcb215-d586-4ae5-97e7-3f4347f03b67.html,,,,,, Acetone oxime,127-06-0,The NOEL in a 90 day sub-chronic oral study in the rat was 10 mg/kg. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7318b0cc-df1b-4b83-aeb1-5e18134c8ccb/documents/IUC5-0d9ea67f-cd14-4b16-a422-354854e72c79_e7579932-82e7-4329-8cea-02416576083a.html,,,,,, Acetone oxime,127-06-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7318b0cc-df1b-4b83-aeb1-5e18134c8ccb/documents/IUC5-0d9ea67f-cd14-4b16-a422-354854e72c79_e7579932-82e7-4329-8cea-02416576083a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Acetone oxime,127-06-0,The substance is of low acute toxicity to mammals by the oral route but is harmful by the dermal route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7318b0cc-df1b-4b83-aeb1-5e18134c8ccb/documents/IUC5-9bdcdcd3-d5bf-4f8d-8afc-70d71af60fa2_e7579932-82e7-4329-8cea-02416576083a.html,,,,,, Acetone oxime,127-06-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7318b0cc-df1b-4b83-aeb1-5e18134c8ccb/documents/IUC5-9bdcdcd3-d5bf-4f8d-8afc-70d71af60fa2_e7579932-82e7-4329-8cea-02416576083a.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, Acetone oxime,127-06-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7318b0cc-df1b-4b83-aeb1-5e18134c8ccb/documents/IUC5-9bdcdcd3-d5bf-4f8d-8afc-70d71af60fa2_e7579932-82e7-4329-8cea-02416576083a.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, Acetyl chloride,75-36-5,"Data waiving: According to column 2 of REACH Annex VII, the acute toxicity studies do not need to be conducted since the substance is classified as corrosive to the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf52aca9-d612-4af0-8047-a2d4e1e6ba83/documents/IUC5-18d9aa86-ec6f-46b8-8885-bbeef8704baa_8bfc2fa5-068c-4e06-b116-21db1b7d4079.html,,,,,, Acetylene,74-86-2, There are no data on oral and dermal repeat dose toxicity. Studies are not technically feasible as the substance is a gas at room temperature. The limited data available on a close related substance indicates low toxicity via the inhalation route. It is concluded that there are no adverse effects resulting from repeat dose exposure below the lower explosive limit (LEL) of acetylene (2.5%; 26750 mg/m3). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1201399e-5beb-4c82-af3d-807562a69904/documents/IUC5-e90c0fcb-cfcf-4497-b742-1da196cc2726_e8c6078e-4961-465e-a8d4-9b0921b9ddce.html,,,,,, Acetylene,74-86-2,"Acetylene has low inhalation toxicity, the LOAEC for mild intoxication in humans with no residual effects is 107,000 mg/m3. There are no data on oral and dermal toxicity (studies are not technically feasible as the substance is a gas at room temperature). Three weight of evidence studies are available. The endpoint value is derived from the most recent and reliable study. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1201399e-5beb-4c82-af3d-807562a69904/documents/IUC5-8cbe3727-4822-4df3-958c-7924641bee0e_e8c6078e-4961-465e-a8d4-9b0921b9ddce.html,,,,,, Acetylene,74-86-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1201399e-5beb-4c82-af3d-807562a69904/documents/IUC5-8cbe3727-4822-4df3-958c-7924641bee0e_e8c6078e-4961-465e-a8d4-9b0921b9ddce.html,,inhalation,LC0,"160,500 mg/m3",adverse effect observed, "Acetylglucosaminidase, β-",9012-33-3,"Beta-N-acetylhexosaminidase was not tested for acute toxicity, but two closely-related enzymes, xylanase and alpha amylase, have been tested for acute toxicity. The acute toxicity of xylanase and alpha amylase was tested by administration by gavage as a single oral dose to a group of rats followed by an observation period of 14 days. No signs of toxicity were observed among the rats treated with a single oral dose of xylanase corresponding to 2536 mg enzyme concentrate dry matter/kg bodyweight (equivalent to 652 mg aep/kg bodyweight) or a single dose of alpha amylase corresponding 2562 mg enzyme concentrate dry matter/kg bodyweight (equivalent to 859 mg aep/kg bodyweight). Based on the similarity of the tested enzymes with beta-N-acetylhexosaminidase - all belonging to the same enzyme sub-subclass - it can be concluded that similar results are expected for beta-N-acetylhexosaminidase. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Toxicological data has been generated within the enzyme producing industry during the last 40 years. Substantial documentation on the safety of the production strains have been generated, and the enzyme test materials are thoroughly characterized. High quality studies for all relevant endpoints, in vivo studies as well as in vitro studies, show that industrial enzymes from well-known and well-characterized production strains have very similar safety profiles across the catalytic activities. Read-across can therefore be applied for the majority of toxicological endpoints. The database can thus be considered of high quality. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1c27f28-5ef7-4261-86c5-ffd9886fc7c3/documents/ba930762-9b34-4583-ab1f-8225410d0504_b82c3701-8989-418f-8e36-f566478ad3ef.html,,,,,, "Adenosine 5'-(trihydrogen diphosphate), monopotassium salt",70285-70-0,"The acute oral toxicity classification of the target substance ADP (CAS 70285-70-0) is currently not harmonised according to the CLP Regulation (EC) 1272/2008. Based on the available acute toxicity data for the source substances ATP, DI-Na (CAS 987-65-5) and AMP (CAS 61-19-8) and according to the read across justification (see attachment ""ADP_70285-70-0_Readacross_Justification” in section 13), the target substance ADP (CAS 70285-70-0) has an LD50 > 2000 mg/kg bodyweight and is therefore not classified for acute toxicity by the oral route according to the EU Regulation on classification, labelling and packaging (CLP) (EC) No 1272/2008.   ATP, DI-Na (CAS 987-65-5) No death occurred after the single 2000 mg/kg bw oral dose of ATP, Di-Na. In conclusion, the LD50 of the test item ATP, Di-Na (CAS No 987-65-5) is higher than 2000 mg/kg bodyweight by oral route in the rat. According to the results of this study, the test item is not classified for acute toxicity according to the EU Regulation on classification, labelling and packaging (CLP) (EC) No 1272/2008.   AMP (CAS 61-19-8) No death occurred after the single 2000 mg/kg bw oral dose of AMP. In conclusion, the LD50 of the test item AMP (CAS No 61-19-8) is higher than 2000 mg/kg bodyweight by oral route in the rat. According to the results of this study, the test item is not classified for acute toxicity according to the EU Regulation on classification, labeling and packaging (CLP) (EC) No 1272/2008. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5d64959-39b0-4cd3-9803-a028e53b1ba3/documents/3d080ad6-43d6-48e6-b34e-43c6503faebd_635944ed-9040-4be3-af0d-9f6afa94f65d.html,,,,,, "Adipic acid, compound with hexane-1,6-diamine (1:1)",3323-53-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ae459a6-b4e6-4905-9275-1022e10cfcbf/documents/IUC5-53264298-5934-4196-9f4d-cc2d09146732_dbf6b94e-c15f-44bc-9b15-ab86313128e3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Adipic acid, compound with hexane-1,6-diamine (1:1)",3323-53-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ae459a6-b4e6-4905-9275-1022e10cfcbf/documents/IUC5-53264298-5934-4196-9f4d-cc2d09146732_dbf6b94e-c15f-44bc-9b15-ab86313128e3.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,100 mg/m3,,rat "Adipic acid, compound with hexane-1,6-diamine (1:1)",3323-53-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ae459a6-b4e6-4905-9275-1022e10cfcbf/documents/IUC5-53264298-5934-4196-9f4d-cc2d09146732_dbf6b94e-c15f-44bc-9b15-ab86313128e3.html,Repeated dose toxicity – local effects,inhalation,NOAEC,10 mg/m3,,rat "Adipic acid, compound with hexane-1,6-diamine (1:1)",3323-53-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ae459a6-b4e6-4905-9275-1022e10cfcbf/documents/IUC5-183d9f9c-d798-47fb-a03a-3d87d269c8e8_dbf6b94e-c15f-44bc-9b15-ab86313128e3.html,,oral,LD50,"4,900 mg/kg bw",, "Adipic acid, compound with hexane-1,6-diamine (1:1)",3323-53-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ae459a6-b4e6-4905-9275-1022e10cfcbf/documents/IUC5-183d9f9c-d798-47fb-a03a-3d87d269c8e8_dbf6b94e-c15f-44bc-9b15-ab86313128e3.html,,dermal,LD50,"7,940 mg/kg bw",, Adiponitrile,111-69-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/46b020e1-2fdf-4840-b6ff-67d21b456031/documents/34bcf4db-f695-4342-91fa-f0f8fbb0839b_ad056a20-cf3a-4cce-bdf1-b2887b3b6b43.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,30.6 mg/m3,,rat Adiponitrile,111-69-3,All supporting studies were within a reasonable range of each other for all the routes of exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46b020e1-2fdf-4840-b6ff-67d21b456031/documents/7445f45e-cc23-4994-8ee2-7975846c90ef_ad056a20-cf3a-4cce-bdf1-b2887b3b6b43.html,,,,,, Adiponitrile,111-69-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46b020e1-2fdf-4840-b6ff-67d21b456031/documents/7445f45e-cc23-4994-8ee2-7975846c90ef_ad056a20-cf3a-4cce-bdf1-b2887b3b6b43.html,,oral,LD50,215 mg/kg bw,adverse effect observed, Adiponitrile,111-69-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46b020e1-2fdf-4840-b6ff-67d21b456031/documents/7445f45e-cc23-4994-8ee2-7975846c90ef_ad056a20-cf3a-4cce-bdf1-b2887b3b6b43.html,,dermal,LD50,"2,134 mg/kg bw",, Adiponitrile,111-69-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46b020e1-2fdf-4840-b6ff-67d21b456031/documents/7445f45e-cc23-4994-8ee2-7975846c90ef_ad056a20-cf3a-4cce-bdf1-b2887b3b6b43.html,,inhalation,LC50,"2,180 mg/m3",adverse effect observed, N-butyrylalanine,59875-04-6,acute oral toxicity: LD50 cut-off >2500 mg/kg bw ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0884481e-2cb7-46b4-9f71-1e9f9df7537e/documents/IUC5-ac3c1d8d-cc49-40e0-bac4-fe10041e6260_6ef4767c-083f-4bfa-b834-22d34accb264.html,,,,,, "Alcohols, C10-16, ethoxylated, sulfates, mono(hydroxyethyl)ammonium salts",157627-92-4,"Oral (subacute, rat, m/f, OECD 422): NOAEL (systemic toxicity) ≥ 930 mg/kg bw/day   Read-across based on grouping of substances (category approach) considering all available data on subacute and subchronic repeated dose toxicity in the Alkyl Ether Sulfates (AES) category in a weight of evidence approach. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58af758d-93f1-4996-be61-3e1f5dc0ccce/documents/49a97601-b220-46ee-aaf2-b83e73039882_a7508493-a5f7-4b08-82a8-e6fb0247702a.html,,,,,, "Alcohols, C10-16, ethoxylated, sulfates, mono(hydroxyethyl)ammonium salts",157627-92-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58af758d-93f1-4996-be61-3e1f5dc0ccce/documents/49a97601-b220-46ee-aaf2-b83e73039882_a7508493-a5f7-4b08-82a8-e6fb0247702a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,>= 930 mg/kg bw/day,,rat "Alcohols, C10-16, ethoxylated, sulfates, mono(hydroxyethyl)ammonium salts",157627-92-4,"Oral LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute oral toxicity in the Alkyl Ether Sulfates (AES) category in a weight of evidence approach.   Inhalation No information required according to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, as data on acute oral and acute dermal toxicity are provided.   Dermal LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute dermal toxicity in the AES category in a weight of evidence approach. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58af758d-93f1-4996-be61-3e1f5dc0ccce/documents/c3b4e9e2-ac3f-446f-a552-f027fe906364_a7508493-a5f7-4b08-82a8-e6fb0247702a.html,,,,,, "Alcohols, C10-16, ethoxylated, sulfates, mono(hydroxyethyl)ammonium salts",157627-92-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58af758d-93f1-4996-be61-3e1f5dc0ccce/documents/c3b4e9e2-ac3f-446f-a552-f027fe906364_a7508493-a5f7-4b08-82a8-e6fb0247702a.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alcohols, C10-16, ethoxylated, sulfates, mono(hydroxyethyl)ammonium salts",157627-92-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58af758d-93f1-4996-be61-3e1f5dc0ccce/documents/c3b4e9e2-ac3f-446f-a552-f027fe906364_a7508493-a5f7-4b08-82a8-e6fb0247702a.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alcohols, C11-14-iso-, C13-rich",68526-86-3,Minimally Toxic. Based on test data for the material. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab76de38-1e69-4a95-b196-cf6a9d5d257f/documents/IUC5-f4d37176-6550-4b16-b8fc-358a0d8ab965_1601b020-68a9-40e2-9398-49f9335ed5ee.html,,,,,, "Alcohols, C12-13, branched and linear, ethoxylated",160901-19-9," Oral (subacute, rat, m/f, OECD 422): NOAEL (systemic toxicity) = 300 mg/kg bw/day Oral (subacute, rat, m/f, OECD 422): NOAEL (local toxicity) ≥ 1000 mg/kg bw/day   Oral (subchronic, rat, m/f, OECD 408): NOAEL (systemic toxicity) = 300 mg/kg bw/day Oral (subchronic, rat, m/f, OECD 408): NOAEL (local toxicity) = 300 mg/kg bw/day   Conclusion based on data obtained with alcohols, C12-13, branched and linear, ethoxylated (CAS No. 160901-19-9, EC No. 500-457-0) and considering all the available data on repeated dose toxicity in the Alcohol Ethoxylates (AE) category, in a Weight-of-Evidence approach. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a584504-9d41-477c-92a3-2ad258fe2802/documents/ffe6880a-d933-4323-af2b-0af0b81c32b4_be91b505-4d5d-41a5-af3d-b753104eba5d.html,,,,,, "Alcohols, C12-13, branched and linear, ethoxylated",160901-19-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a584504-9d41-477c-92a3-2ad258fe2802/documents/ffe6880a-d933-4323-af2b-0af0b81c32b4_be91b505-4d5d-41a5-af3d-b753104eba5d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Alcohols, C12-13, branched and linear, ethoxylated",160901-19-9," Oral (similar OECD 401): LD50 (rat, m) = 14865 mg/kg bw, LD50 (rat, f) = 13627 mg/kg bw Conclusion based on data obtained with alcohols, C12-13, branched and linear, ethoxylated (CAS No. 160901-19-9, EC No. 500-457-0) and considering all available data on acute toxicity in the Alcohol Ethoxylates (AE) category in a Weight-of-Evidence approach. Inhalation: No study required as the inhalation route of exposure is considered less relevant than the dermal route for AE substances. Dermal: According to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, no study is required as the AE substances do not meet the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a584504-9d41-477c-92a3-2ad258fe2802/documents/IUC5-11dfc30c-4579-4042-9012-e2ce4efc23f2_be91b505-4d5d-41a5-af3d-b753104eba5d.html,,,,,, "Alcohols, C12-13, branched and linear, ethoxylated",160901-19-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a584504-9d41-477c-92a3-2ad258fe2802/documents/IUC5-11dfc30c-4579-4042-9012-e2ce4efc23f2_be91b505-4d5d-41a5-af3d-b753104eba5d.html,,oral,LD50,"> 13,000 mg/kg bw",no adverse effect observed, "Alcohols, C12-13, branched and linear, ethoxylated, sulfates, sodium salts",161074-79-9," The assessment is based on the data currently available. New studies, based on the category review and the final decisions issued for some of the category substances, which are also relevant for this assessment, are currently being conducted. The hazard assessment with respect to repeated dose toxicity will be updated once all ongoing studies have been finalised. For the whole category of alcohol ethoxysulfates (AES) a oral NOAEL of 300 mg/kg bw/d was established. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58153558-1e28-4bfe-802a-ce1b63841938/documents/IUC5-28f347b3-a359-4853-acd5-7a84748ce06a_1e05f992-085d-42d0-b0f2-b316cc8f8de4.html,,,,,, "Alcohols, C12-13, branched and linear, ethoxylated, sulfates, sodium salts",161074-79-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58153558-1e28-4bfe-802a-ce1b63841938/documents/IUC5-28f347b3-a359-4853-acd5-7a84748ce06a_1e05f992-085d-42d0-b0f2-b316cc8f8de4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Alcohols, C12-13, branched and linear, ethoxylated, sulfates, sodium salts",161074-79-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58153558-1e28-4bfe-802a-ce1b63841938/documents/IUC5-28f347b3-a359-4853-acd5-7a84748ce06a_1e05f992-085d-42d0-b0f2-b316cc8f8de4.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,300 mg/kg bw/day,,rat "Alcohols, C12-13, branched and linear, ethoxylated, sulfates, sodium salts",161074-79-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58153558-1e28-4bfe-802a-ce1b63841938/documents/IUC5-28f347b3-a359-4853-acd5-7a84748ce06a_1e05f992-085d-42d0-b0f2-b316cc8f8de4.html,Repeated dose toxicity – local effects,dermal,NOAEL,397 ,adverse effect observed, "Alcohols, C12-13, branched and linear, ethoxylated, sulfates, sodium salts",161074-79-9,"Oral LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute oral toxicity in the Alkyl Ether Sulfates (AES) category in a Weight-of-Evidence approach.   Inhalation No information required according to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, as data on acute oral and acute dermal toxicity are provided.   Dermal LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute dermal toxicity in the AES category in a Weight-of-Evidence approach. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate and reliable (Klimisch score 1 and 2) studies from various source substances in the Alkyl Ether Sulfates (AES) category with similar structures and intrinsic properties. Read-across is justified based on common toxicokinetic behaviour and consistent trends in environmental fate, ecotoxicological and toxicological properties of the category member substances. The database of the AES category is thus sufficient to fulfil the standard information requirements set out in Annex VII, Section 8.5, in accordance with Annex XI, Section 1.5, of the REACH Regulation (EC) No. 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate and reliable (Klimisch score 1 and 2) studies from various source substances in the Alkyl Ether Sulfates (AES) category with similar structures and intrinsic properties. Read-across is justified based on common toxicokinetic behaviour and consistent trends in environmental fate, ecotoxicological and toxicological properties of the category member substances. The database of the AES category is thus sufficient to fulfil the standard information requirements set out in Annex VIII, Section 8.5, in accordance with Annex XI, Section 1.5, of the REACH Regulation (EC) No. 1907/2006. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58153558-1e28-4bfe-802a-ce1b63841938/documents/IUC5-b22c8e15-73fc-48d2-a12a-e791dacc2946_1e05f992-085d-42d0-b0f2-b316cc8f8de4.html,,,,,, "Alcohols, C12-13, branched and linear, ethoxylated, sulfates, sodium salts",161074-79-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58153558-1e28-4bfe-802a-ce1b63841938/documents/IUC5-b22c8e15-73fc-48d2-a12a-e791dacc2946_1e05f992-085d-42d0-b0f2-b316cc8f8de4.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alcohols, C12-13, branched and linear, ethoxylated, sulfates, sodium salts",161074-79-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58153558-1e28-4bfe-802a-ce1b63841938/documents/IUC5-b22c8e15-73fc-48d2-a12a-e791dacc2946_1e05f992-085d-42d0-b0f2-b316cc8f8de4.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alcohols, C12-13-branched and linear",740817-83-8,"In a guideline 28-day study, an oral NOAEL of 300 mg/kg bw/day was determined for Safol 23 (Sasol 1999) but the effects seen in this study are not ascribed to a dose response effect but rather are associated with the method of dosing, and therefore are not suitable as a basis for DNEL. In studies on related materials, oral NOAELS were 2000 mg/kg bw/day for Dodecanol (Hansen 1992a) and 1440 mg/kg bw/day for Alcohols C7-11 branched and linear (Hellwig & Jackh 1997). A read-across from a reliable 13-week dietary study in rats using Hexanol reported a NOAEL of 1127 mg/kg bw/day and no adverse effects were noted at any of the dose levels administered during the study (Scientific Associates Inc. 1966). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce1ed6e2-8659-435c-8486-e4e1b57bfa9a/documents/IUC5-f1e605d0-99a1-4456-8c4d-c669345cedf3_cec69d84-5f46-4398-8362-95485a55647f.html,,,,,, "Alcohols, C12-13-branched and linear",740817-83-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce1ed6e2-8659-435c-8486-e4e1b57bfa9a/documents/IUC5-f1e605d0-99a1-4456-8c4d-c669345cedf3_cec69d84-5f46-4398-8362-95485a55647f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,723 mg/kg bw/day,,rat "Alcohols, C12-13-branched and linear",740817-83-8,"The key study for acute oral toxicity reports an LD50 value of >2000mg/kg with unremarkable findings at necropsy (Sasol, 1998; rel 1). Similarly, an LD50 of >2000mg/kg is reported for acute dermal toxicity (Sasol, 1998; rel 1). The data for acute inhalation toxicity is waived based on the low toxicity of related alcohols via the inhalation route across category, and the availability of high reliability studies via the oral and dermal routes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce1ed6e2-8659-435c-8486-e4e1b57bfa9a/documents/IUC5-ede2ff2f-222c-4610-bd1a-77ac0f01bfd2_cec69d84-5f46-4398-8362-95485a55647f.html,,,,,, "Alcohols, C12-14",80206-82-2,"Oral repeated dose toxicity The NOAEL for 13 week dietary feeding study in rats is ca 750 mg/kg/day (males 723, females 875) based on reduced weight gain and food consumption. The toxicological significance of observed changes in organ weights, all in the absence of histopathological change, is questionable. Increased liver weights at higher dose levels may be indicative of a mild adaptive effect on the liver.In view of the structural and chemical similarities, it is considereed that the results of the study can be used for read-across to Alcohols, C12-14.Dermal repeated dose toxicity A 90-day dermal toxicity study in rats with fatty alcohol blend (56.7% decanol, 42.7% octanol) at dose levels of 0, 100, 300, or 1,000 mg/kg resulted in severe irritation at the application site. Severe irritation including fissuring of the skin occurred in 40% of the animals at 100 mg/kg/day and 80% of the animals at the limit dose. Slight changes in hematology, clinical chemistry, and organ weights were noted at the limit dose of 1,000 mg/kg/day. NOAEL has been based on a local irritation effect rather than a systemic effect. Therefore it is proposed (by the author of the EPSR) that on the basis of a lack of systemic effects reported in the study, the NOAEL following dermal administration of fatty alcohol blend for a minimum of 90 days is greater than 1000 mg/kg/day.Inhalation repeated dose toxicity Under the conditions of the test no treatment-related toxic effects were found in male and female Wistar rats which were exposed to 2-ethylhexanol vapor up to 120 ppm ie. 638.4 mg/m³ . (Klimisch HJ; Deckardt K; Gembardt C; Hildebrand B,1998).The substance Alcohols, C12-14, the subject of this dossier) is expected to exhibit very similar toxicity due to its close structural similarity to 2-ethylhexanol.Comparable metabolism would occur. Correcting for molecular weight, a conservative NOAEC of 980.6 mg/m3 can be derived (638.4 x 200) / 130.2 =980.6 mg/m3 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9d9bd34-00e6-4d49-aecc-24405445e307/documents/IUC5-b4a4a282-8c53-4401-9156-513ebc4e0d7e_bd7ef0d4-1e5d-4e6a-95c8-38a447f3e98e.html,,,,,, "Alcohols, C12-14",80206-82-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9d9bd34-00e6-4d49-aecc-24405445e307/documents/IUC5-b4a4a282-8c53-4401-9156-513ebc4e0d7e_bd7ef0d4-1e5d-4e6a-95c8-38a447f3e98e.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Alcohols, C12-14",80206-82-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9d9bd34-00e6-4d49-aecc-24405445e307/documents/IUC5-b4a4a282-8c53-4401-9156-513ebc4e0d7e_bd7ef0d4-1e5d-4e6a-95c8-38a447f3e98e.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,980.6 mg/m3,,rat "Alcohols, C12-14",80206-82-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9d9bd34-00e6-4d49-aecc-24405445e307/documents/IUC5-b4a4a282-8c53-4401-9156-513ebc4e0d7e_bd7ef0d4-1e5d-4e6a-95c8-38a447f3e98e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Alcohols, C12-14",80206-82-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9d9bd34-00e6-4d49-aecc-24405445e307/documents/IUC5-b4a4a282-8c53-4401-9156-513ebc4e0d7e_bd7ef0d4-1e5d-4e6a-95c8-38a447f3e98e.html,Repeated dose toxicity – local effects,dermal,NOAEL,5.62 mg/cm2,no adverse effect observed,rat "Alcohols, C12-14",80206-82-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9d9bd34-00e6-4d49-aecc-24405445e307/documents/IUC5-b4a4a282-8c53-4401-9156-513ebc4e0d7e_bd7ef0d4-1e5d-4e6a-95c8-38a447f3e98e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,32.6 mg/m3,no adverse effect observed,rat "Alcohols, C12-14",80206-82-2,"- Acute oral toxicity: The acute oral LD50 in male/female rats is >10000 mg/kg bw . No significant gross abnormalities were seen at autopsy. )). This show that Alcohols, C12-14 is practically nontoxic for acute oral toxicity. Alcohols, C12-14 was not classified according to EU or GHS criteria. -Acute Dermal Toxicity: The rabbit dermal LD50 of Alcohols, C12-14 was > 2000 mg/kg. This show that Alcohols, C12-14 is not toxic for acute Dermal toxicity . Alcohols, C12-14 was not classified according to EU or GHS criteria -Acute inhalation toxicity :The 4 hour rat inhalational LC50 for Alcohols, C12-14 is >saturated vapour concentration. There were no signs of toxicity during exposure or the subsequent observation period..The rat 4 hour LC50 for Alcohols, C12-14 is > saturated vapour concentration. Results indicate that Alcohols, C12-14 is not toxic for acute inhalation toxicity. Alcohols, C12-14 was not classified according to EU or GHS criteria. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9d9bd34-00e6-4d49-aecc-24405445e307/documents/IUC5-edee9144-cb52-42e0-bffd-df641ef779e8_bd7ef0d4-1e5d-4e6a-95c8-38a447f3e98e.html,,,,,, "Alcohols, C12-14",80206-82-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9d9bd34-00e6-4d49-aecc-24405445e307/documents/IUC5-edee9144-cb52-42e0-bffd-df641ef779e8_bd7ef0d4-1e5d-4e6a-95c8-38a447f3e98e.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Alcohols, C12-14",80206-82-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9d9bd34-00e6-4d49-aecc-24405445e307/documents/IUC5-edee9144-cb52-42e0-bffd-df641ef779e8_bd7ef0d4-1e5d-4e6a-95c8-38a447f3e98e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Alcohols, C12-14",80206-82-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9d9bd34-00e6-4d49-aecc-24405445e307/documents/IUC5-edee9144-cb52-42e0-bffd-df641ef779e8_bd7ef0d4-1e5d-4e6a-95c8-38a447f3e98e.html,,inhalation,LC50,40.08 mg/m3,no adverse effect observed, "Alcohols, C12-15-branched and linear",90604-40-3,"In the key study, no adverse effects were seen after dietary administration of Alcohols, C14-15-branched and linear for 90 days to rats Alcohols, C12-15-branched and linear (Ito et al., 1978). This is supported by a limited study in which no adverse effects were seen in the liver or testis after oral administration of Alcohols C12-15 branched and linear to male rats at 209 mg/kg bw/day for 14 days (Rhodes et al. 1984). A read-across from a reliable 13-week dietary study in rats using Hexanol reported a NOAEL of 1127 mg/kg bw/day and no adverse effects were noted at any of the dose levels administered during the study (Scientific Associates Inc. 1966). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cccf7b6e-2942-4e6a-9e8a-09b5c3510c06/documents/IUC5-ddcde4ff-5b08-480a-bae5-a13db7057640_3fab4cc2-690b-47d9-872b-5ea289ed26d5.html,,,,,, "Alcohols, C12-15-branched and linear",90604-40-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cccf7b6e-2942-4e6a-9e8a-09b5c3510c06/documents/IUC5-ddcde4ff-5b08-480a-bae5-a13db7057640_3fab4cc2-690b-47d9-872b-5ea289ed26d5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,548 mg/kg bw/day",,rat "Alcohols, C12-15-branched and linear",90604-40-3,"The key study on acute oral toxicity in rat reports the LD50 value of >5000 (Biolab 1991;rel 2). The key study for acute inhalation toxicity reports the LC50 value to be >saturated vapour concentration (Blair 1980; rel 2). The acute dermal key finding is an LD50 value of 3320 mg/kg (Clark& Coombs, 1978; rel 2). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cccf7b6e-2942-4e6a-9e8a-09b5c3510c06/documents/IUC5-da1bd0f0-c463-4ad4-b91c-f1abf11ee836_3fab4cc2-690b-47d9-872b-5ea289ed26d5.html,,,,,, "Alcohols, C12-15-branched and linear",90604-40-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cccf7b6e-2942-4e6a-9e8a-09b5c3510c06/documents/IUC5-da1bd0f0-c463-4ad4-b91c-f1abf11ee836_3fab4cc2-690b-47d9-872b-5ea289ed26d5.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Alcohols, C12-15-branched and linear",90604-40-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cccf7b6e-2942-4e6a-9e8a-09b5c3510c06/documents/IUC5-da1bd0f0-c463-4ad4-b91c-f1abf11ee836_3fab4cc2-690b-47d9-872b-5ea289ed26d5.html,,dermal,LD50,"3,320 mg/kg bw",no adverse effect observed, "Alcohols, C12-18, ethoxylated",68213-23-0,For the whole category of alcohol ethoxylates (AE) a NOAEL of 500 mg/kg bw/day was established. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a2e9453-ecc6-468f-b3d2-a09ac37d40f0/documents/IUC5-9aadb629-76ed-4af7-bf5f-f8b7047d47b1_d4161703-e229-47bf-b0d4-820013b1f8bb.html,,,,,, "Alcohols, C12-18, ethoxylated",68213-23-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a2e9453-ecc6-468f-b3d2-a09ac37d40f0/documents/IUC5-9aadb629-76ed-4af7-bf5f-f8b7047d47b1_d4161703-e229-47bf-b0d4-820013b1f8bb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Alcohols, C12-18, ethoxylated",68213-23-0,"Oral (OECD 401), rat: LD50 > 5050 mg/kg bwDermal (OECD 402), rat and rabbit: LD50 > 2000 mg/kg bwInhalation (OECD 403), rat, 4 h, (limit test): LC50 > 1600mg/m³ (maximum technically attainable concentration) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a2e9453-ecc6-468f-b3d2-a09ac37d40f0/documents/IUC5-1a76b812-f513-4e0f-aed6-cb6cf9b3a8b9_d4161703-e229-47bf-b0d4-820013b1f8bb.html,,,,,, "Alcohols, C12-18, ethoxylated",68213-23-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a2e9453-ecc6-468f-b3d2-a09ac37d40f0/documents/IUC5-1a76b812-f513-4e0f-aed6-cb6cf9b3a8b9_d4161703-e229-47bf-b0d4-820013b1f8bb.html,,oral,LD50,"5,050 mg/kg bw",no adverse effect observed, "Alcohols, C12-18, ethoxylated",68213-23-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a2e9453-ecc6-468f-b3d2-a09ac37d40f0/documents/IUC5-1a76b812-f513-4e0f-aed6-cb6cf9b3a8b9_d4161703-e229-47bf-b0d4-820013b1f8bb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Alcohols, C12-18, ethoxylated",68213-23-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a2e9453-ecc6-468f-b3d2-a09ac37d40f0/documents/IUC5-1a76b812-f513-4e0f-aed6-cb6cf9b3a8b9_d4161703-e229-47bf-b0d4-820013b1f8bb.html,,inhalation,LC50,"1,600 mg/m3",no adverse effect observed, "Alcohols, C13-15",90604-31-2," Acute Oral Toxicity:  In Acute oral toxicity, LD50 value was predicted based on OECD QSAR toolbox for target Alcohols, C13-15 (90604-31-2) was estimated to be 7101.12mg/kg bw, and for different studies available on the structurally similar read across substance tridecyl alcohol (112 -70 -9)and Tridecanol(26248-42-0) . All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Alcohols, C13-15 (90604-31-2)cannot be classified for acute oral toxicity. Acute Dermal Toxicity: In Acute dermal toxicity, LD50 value was predicted based on OECD QSAR toolbox for target substance Alcohols, C13-15 (90604-31-2) was estimated to be >2000 mg/kg bw, and for different studies available on structurally similar read across substance 1-Tetradecanol (112-72-1) and tridecyl alcohol (122-70-9). All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Alcohols, C13-15 (90604-31-2) cannot be classified for acute dermal toxicity.   ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4da9d69-2755-48ab-a2c9-fb6ca7c9d006/documents/2f80c1eb-bf3c-4b0d-b366-08f0c61aa7e6_6966d36f-9f36-4e43-8f0e-2d4198cb7f1b.html,,,,,, "Alcohols, C13-15",90604-31-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4da9d69-2755-48ab-a2c9-fb6ca7c9d006/documents/2f80c1eb-bf3c-4b0d-b366-08f0c61aa7e6_6966d36f-9f36-4e43-8f0e-2d4198cb7f1b.html,,oral,LD50,"7,101.12 mg/kg bw",no adverse effect observed, "Alcohols, C13-15",90604-31-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4da9d69-2755-48ab-a2c9-fb6ca7c9d006/documents/2f80c1eb-bf3c-4b0d-b366-08f0c61aa7e6_6966d36f-9f36-4e43-8f0e-2d4198cb7f1b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Alcohols, C13-15-branched and linear",85566-16-1,"The NOAEL for oral repeated dose toxicity was 150 mg/kg bw after oral administration (gavage) in an OECD 406 study, based on the structural analogue CAS 10042-59-8.In support, the NOAEL in an OECD 422 (BASF, 2022) with C13-C15 alcohol was 1000 mg/kg bw for systemic toxicicty and reproductive performance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d10466e0-6e3c-45cd-9375-3fe095315df3/documents/IUC5-ad3273b7-8d1b-45fb-a898-f6b546d11b05_28be3c4d-6944-4220-82b0-a7ce59b5512a.html,,,,,, "Alcohols, C13-15-branched and linear",85566-16-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d10466e0-6e3c-45cd-9375-3fe095315df3/documents/IUC5-ad3273b7-8d1b-45fb-a898-f6b546d11b05_28be3c4d-6944-4220-82b0-a7ce59b5512a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Alcohols, C13-15-branched and linear",85566-16-1,The oral and dermal LD50 values for both structural analoques were greater than 2000mg/kg.There was no mortality after inhalation of a saturated atmosphere of CAS 27458-92-0 for 8h. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d10466e0-6e3c-45cd-9375-3fe095315df3/documents/IUC5-b72ee4a3-619a-4f47-a489-6875889e01d0_28be3c4d-6944-4220-82b0-a7ce59b5512a.html,,,,,, "Alcohols, C13-15-branched and linear",85566-16-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d10466e0-6e3c-45cd-9375-3fe095315df3/documents/IUC5-b72ee4a3-619a-4f47-a489-6875889e01d0_28be3c4d-6944-4220-82b0-a7ce59b5512a.html,,oral,LD50,"5,400 mg/kg bw",adverse effect observed, "Alcohols, C13-15-branched and linear",85566-16-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d10466e0-6e3c-45cd-9375-3fe095315df3/documents/IUC5-b72ee4a3-619a-4f47-a489-6875889e01d0_28be3c4d-6944-4220-82b0-a7ce59b5512a.html,,dermal,LD50,"5,960 mg/kg bw",adverse effect observed, "Alcohols, C13-15-branched and linear",85566-16-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d10466e0-6e3c-45cd-9375-3fe095315df3/documents/IUC5-b72ee4a3-619a-4f47-a489-6875889e01d0_28be3c4d-6944-4220-82b0-a7ce59b5512a.html,,inhalation,discriminating conc.,300 mg/m3,no adverse effect observed, "Alcohols, C14-18 and C16-18-unsatd.",68155-00-0, Assess the acute oral toxicity of the test substance to the rat. The acute median lethal oral dose (LD50) to rats of the test substance was demonstrated to be greater than 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b508a00-6a04-4de0-8889-d40e2496b088/documents/b4ff385d-6e9f-4b72-aca6-466ae5c3f483_75a64a54-3346-4081-ab53-5abd07349fe9.html,,,,,, "Alcohols, C14-18 and C16-18-unsatd.",68155-00-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b508a00-6a04-4de0-8889-d40e2496b088/documents/b4ff385d-6e9f-4b72-aca6-466ae5c3f483_75a64a54-3346-4081-ab53-5abd07349fe9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Alcohols, C16-18 and C18-unsatd., ethoxylated, sulfates, sodium salts",157627-95-7,"Oral (subacute, rat, m/f, OECD 422): NOAEL (systemic toxicity) ≥ 930 mg/kg bw/day   Conclusion based on data obtained with alcohols, C16-18 and C18-unsatd., ethoxylated, sulfates, sodium salts (CAS No. 157627-95-7, EC No. 500-345-1) and considering all available data on repeated dose toxicity in the Alkyl Ether Sulfates (AES) category in a weight of evidence approach. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c1b9894-b6ab-4582-8af3-2b16014e29c1/documents/778acc4e-7fdb-4497-bc91-37afbc6b0b80_9cc01817-3e46-4e95-a41b-b0b87e49f49e.html,,,,,, "Alcohols, C16-18 and C18-unsatd., ethoxylated, sulfates, sodium salts",157627-95-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c1b9894-b6ab-4582-8af3-2b16014e29c1/documents/778acc4e-7fdb-4497-bc91-37afbc6b0b80_9cc01817-3e46-4e95-a41b-b0b87e49f49e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,>= 930 mg/kg bw/day,,rat "Alcohols, C16-18 and C18-unsatd., ethoxylated, sulfates, sodium salts",157627-95-7,"Oral LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute oral toxicity in the Alkyl Ether Sulfates (AES) category in a weight of evidence approach.   Inhalation No information required according to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, as data on acute oral and acute dermal toxicity are provided.   Dermal LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute dermal toxicity in the AES category in a weight of evidence approach. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c1b9894-b6ab-4582-8af3-2b16014e29c1/documents/edb621eb-895a-4646-86bd-293f5c380bb5_9cc01817-3e46-4e95-a41b-b0b87e49f49e.html,,,,,, "Alcohols, C16-18 and C18-unsatd., ethoxylated, sulfates, sodium salts",157627-95-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c1b9894-b6ab-4582-8af3-2b16014e29c1/documents/edb621eb-895a-4646-86bd-293f5c380bb5_9cc01817-3e46-4e95-a41b-b0b87e49f49e.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alcohols, C16-18 and C18-unsatd., ethoxylated, sulfates, sodium salts",157627-95-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c1b9894-b6ab-4582-8af3-2b16014e29c1/documents/edb621eb-895a-4646-86bd-293f5c380bb5_9cc01817-3e46-4e95-a41b-b0b87e49f49e.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alcohols, C18-22, distn. residues",1160164-88-4,"A subacute as well as a subchronic oral gavage study were conducted to assess the repeat dose toxicity of alcohols, C18-22, distillation residues (CAS No. 1160164-88-4). The test item was dosed to rats up to 1000 mg/kg for 28d and 90d, respectively, with no obvious evidence of toxicity. Consequently a dose of 1000 mg/kg/day was considered to be a No-Observed-Effect-Level (NOEL) in this study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cab49aaa-8d60-435c-816a-60b1fa413672/documents/IUC5-ff98404a-d1a0-456b-b429-8eb17b828bef_dbe73d80-3085-4287-8bea-e6f7f9ef5034.html,,,,,, "Alcohols, C18-22, distn. residues",1160164-88-4,"ORAL: An acute oral toxicity study in female Sprague-Dawley rats was conducted with Alcohols, C18-22, distn. residues. This study was conducted according to OECD 425 and was GLP compliant. On the basis of this study the acute oral LD50 for alcohols, C18-22, distillation residues was reported at >2000 mg/kg.bw in female rats.DERMAL: A reliable (Klimisch 1) acute dermal toxicity study was conducted in Sprague-Dawley rats (5/sex/dose) with Alcohols, C18-22, distn. residues. This study was conducted according to OECD 402 and was GLP compliant. On the basis of this study the acute dermal LD50 for Alcohols, C18-22, distn. Residues was reported at >2020 mg/kg.bw in male/female rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cab49aaa-8d60-435c-816a-60b1fa413672/documents/IUC5-1d01083f-b5be-4921-b0ea-77589dc435db_dbe73d80-3085-4287-8bea-e6f7f9ef5034.html,,,,,, "Alcohols, C6-24 and C6-24-unsatd., distn. residues",102242-48-8,"A subchronic orientating study (13 weeks, rat, gavage) conducted 1980 according to an in house protocol (Henkel R 9500428, 1980) is available. Since the study was conducted prior to the implementation of currently acknowledged testing guidelines (OECD TG 408), current testing requirements are not fulfilled; nevertheless the study provides suitable basic data, acceptable for assessment of the toxic potential of the compound following repeated dosing. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6acc120-6f82-4ecf-9872-f58ef9304647/documents/cbd15f36-8f93-42ee-816a-afea5c73a7e2_0d4b422a-e287-4027-a8f1-34799092da30.html,,,,,, "Alcohols, C6-24 and C6-24-unsatd., distn. residues",102242-48-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6acc120-6f82-4ecf-9872-f58ef9304647/documents/cbd15f36-8f93-42ee-816a-afea5c73a7e2_0d4b422a-e287-4027-a8f1-34799092da30.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Alcohols, C6-24 and C6-24-unsatd., distn. residues",102242-48-8,"An acute oral toxicity study according to OECD TG 423 (LD50 > 2000 mg/kg bw) as well as an acute dermal toxicity study according to OECD TG 402 (LD50 > 2000 mg/kg bw) are available. Additionally, company data from Henkel dated 1972 are available, which refer to an acute oral toxicity study with rats, having resulted in a LD0 value > 20000 mg/kg bw, and thus, in a LD50 > 20000 mg/kg bw. Furthermore, for alcohols, C6-24, distn. residues (CAS 102242-49-9), an oral and a dermal acute toxicity study are available, which are suitable for read across; because of structural and composition analogy, the results of both substances are similar.Acute toxicity:BASF Report 10A0276/12X160 from 2012: LD50 (oral) > 2000 mg/kg bw (LD50 (oral), cut-off = 5000 mg/kg bw)Henkel company data from 1972: LD50 (oral) > 20000 mg/kg bwBASF Report 11A0276/12X161 from 2012: LD50 (dermal) > 2000 mg/kg bwRead across substance CAS 102242-49-9:Cognis (now BASF) Report TBD880150: LD50 > 2000 mg/kg bw for acute oral toxicityCognis (now BASF) Report C0901283-5: LD50 > 2000 mg/kg bw for acute dermal toxicity No data are available for the acute inhalation toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6acc120-6f82-4ecf-9872-f58ef9304647/documents/9c8a791e-db27-4faa-89e0-9894374cb247_0d4b422a-e287-4027-a8f1-34799092da30.html,,,,,, "Alcohols, C6-24, distn. residues",102242-49-9,"For a close homologue of the registered substance, one relevant (and reliable) subchronic study (90 day, rat, oral ) is available. The oral NOAEL of 250 mg/kg bw is the result of a read-across approach to the registered substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20fc55ff-1e64-4c7a-aeb9-6b4af30e0c13/documents/IUC5-49435c31-5959-4235-b68f-39cd656a386f_000623f4-de76-4474-98aa-3c5e5677ccc1.html,,,,,, "Alcohols, C6-24, distn. residues",102242-49-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20fc55ff-1e64-4c7a-aeb9-6b4af30e0c13/documents/IUC5-49435c31-5959-4235-b68f-39cd656a386f_000623f4-de76-4474-98aa-3c5e5677ccc1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Alcohols, C6-24, distn. residues",102242-49-9,"Oral: In the only available (and reliable study), the LD50 was determined to be > 2000 mg/kg bw.Dermal: In the only available (and reliable study), the LD50 was determined to be > 2000 mg/kg bw.Therefore, the test substance is practically not acutely toxic. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20fc55ff-1e64-4c7a-aeb9-6b4af30e0c13/documents/IUC5-fedd5bda-e34d-41f7-adb9-0a280f11e920_000623f4-de76-4474-98aa-3c5e5677ccc1.html,,,,,, "Alcohols, C6-24, distn. residues",102242-49-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20fc55ff-1e64-4c7a-aeb9-6b4af30e0c13/documents/IUC5-fedd5bda-e34d-41f7-adb9-0a280f11e920_000623f4-de76-4474-98aa-3c5e5677ccc1.html,,oral,LD50,"2,000 mg/kg bw",, "Alcohols, C6-24, distn. residues",102242-49-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20fc55ff-1e64-4c7a-aeb9-6b4af30e0c13/documents/IUC5-fedd5bda-e34d-41f7-adb9-0a280f11e920_000623f4-de76-4474-98aa-3c5e5677ccc1.html,,dermal,LD50,"2,000 mg/kg bw",, "Alcohols, C6-C8-(even numbered, linear)-ethoxylated (<2,5 EO)",1426148-68-6,"Repeated dose toxicity: oral - systemic effectsA testing proposol regarding a 90-d oral toxicity study is submitted. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The available data allows for route-to-route extrapolation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e599188-1ed3-4cbc-a37e-070658b89bd7/documents/IUC5-b47d2976-624b-495a-9ab6-b35f8ad9b6fb_6c1b77f4-b50b-4c83-804f-b00cf6861931.html,,,,,, "Alcohols, C6-C8-(even numbered, linear)-ethoxylated (<2,5 EO)",1426148-68-6,"There are no human data on acute toxicity for the registered substance. In animals, test results with this compound are available for the oral route of exposure indicating LD50 values of greater 2000 mg/kg body weight for this exposure routes. As inhalation is not an exposure route of major concern and LD50 value for acute oral toxicity is greater than 2000 mg/kg body weight indicative of a very low acute systemic toxic potential, no experimental studies have been performed using the inhalation route of exposure. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Guideline study according to GLP available. No derivations and/or confounders. Klimisch rating 1 indicates reliability without restrictions. Information valid and meets data requirements. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e599188-1ed3-4cbc-a37e-070658b89bd7/documents/IUC5-62f3e052-5ec1-4365-903e-41618fb5a52a_6c1b77f4-b50b-4c83-804f-b00cf6861931.html,,,,,, "Alcohols, C6-C8-(even numbered, linear)-ethoxylated (<2,5 EO)",1426148-68-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e599188-1ed3-4cbc-a37e-070658b89bd7/documents/IUC5-62f3e052-5ec1-4365-903e-41618fb5a52a_6c1b77f4-b50b-4c83-804f-b00cf6861931.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Alcohols, C7-9-iso-, C8-rich",68526-83-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2547faa-462e-4366-9b9f-09adb0c1a44b/documents/IUC5-0be31b1a-d731-4dde-9b8c-d20943d050bf_3169907c-e78a-4547-bc1a-ea9f14f885ca.html,,oral,LD50,"2,000 mg/kg bw",, "Alcohols, C7-9-iso-, C8-rich",68526-83-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2547faa-462e-4366-9b9f-09adb0c1a44b/documents/IUC5-0be31b1a-d731-4dde-9b8c-d20943d050bf_3169907c-e78a-4547-bc1a-ea9f14f885ca.html,,dermal,LD50,"2,632 mg/kg bw",, "Alcohols, C8-10, ethoxylated",71060-57-6," Oral (subacute, rat): NOAEL (systemic toxicity) ≥ 1000 mg/kg bw/day Read-across based on grouping of substances (category approach) considering all available data on subacute repeated dose toxicity in the 'linear' subgroup of the Alcohol Ethoxylates (AE) category. Oral (subchronic, rat): NOAEL (systemic toxicity) ≥ 1000 mg/kg bw/day Read-across based on grouping of substances (category approach) based on combined subacute repeated dose toxicity studies with the reproductive / developmental toxicity screening test (OECD 422) conducted with several member substances of the 'linear' subgroup of the AE category. Pursuant to compliance check final decision for a number of substances in the AE category, several subchronic repeated dose toxicity studies according to OECD guideline 408 are currently ongoing. The NOAEL for subchronic systemic toxicity established for the linear AE substances will be re-evaluated once the results of the OECD 408 studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45b09806-f40e-441c-b59d-5added1f6786/documents/7745eb0f-a8a6-4ce4-9dd5-364c5a6d22dd_be7082f0-074c-4d22-96cc-7319b49e2d9b.html,,,,,, "Alcohols, C8-10, ethoxylated",71060-57-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45b09806-f40e-441c-b59d-5added1f6786/documents/7745eb0f-a8a6-4ce4-9dd5-364c5a6d22dd_be7082f0-074c-4d22-96cc-7319b49e2d9b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Alcohols, C8-10, ethoxylated",71060-57-6," An acute toxicity study using either route of exposure is not required for alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) according to the REACH Regulation (EC) No. 1907/2006, Annexes VII and VIII, Section 8.5, Column 2, because the subsance is classified as corrosive to the skin. The hazard conclusion is based on the trend from corrosive (C8 substance) to non-irritant (C10-C12 substances) observed in the Alcohol Ethoxylates (AE) category leading to the worst-case conclusion that alcohols C8-10, ethoxylated < 2.5 EO (CAS No. 71060-57-6, EC No. 615-247-5) is corrosive. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45b09806-f40e-441c-b59d-5added1f6786/documents/612659c2-c46c-4531-8317-4a7d66d8307b_be7082f0-074c-4d22-96cc-7319b49e2d9b.html,,,,,, "Alcohols, C8-10, ethoxylated, sulfates, ammonium salts",68891-29-2,"Oral (subacute, rat, m/f, OECD 422): NOAEL (systemic toxicity) ≥ 750 mg/kg bw/day Oral (subacute, rat, m/f, OECD 422): NOAEL (local toxicity) = 250 mg/kg bw/day   Oral (subchronic, rat, m/f, OECD 408): NOAEL (systemic toxicity) ≥ 750 mg/kg bw/day Oral (subchronic, rat, m/f, OECD 408): NOAEL (local toxicity) = 90 mg/kg bw/day   Conclusion based on data obtained with alcohols C8-10, ethoxylated, sulfates ammonium salts (CAS No. 68891-29-2, EC No. 500-233-2) and considering all available data on repeated dose toxicity in the Alkyl Ether Sulfates (AES) category in a weight of evidence approach. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1f21b72-ca2e-4a26-ae11-ea527b5ca853/documents/12714120-f6db-4de7-9a90-195318a95db8_ff43d4b2-358b-4d7c-99e7-626d28367686.html,,,,,, "Alcohols, C8-10, ethoxylated, sulfates, ammonium salts",68891-29-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1f21b72-ca2e-4a26-ae11-ea527b5ca853/documents/12714120-f6db-4de7-9a90-195318a95db8_ff43d4b2-358b-4d7c-99e7-626d28367686.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,>= 750 mg/kg bw/day,,rat "Alcohols, C8-10, ethoxylated, sulfates, ammonium salts",68891-29-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1f21b72-ca2e-4a26-ae11-ea527b5ca853/documents/12714120-f6db-4de7-9a90-195318a95db8_ff43d4b2-358b-4d7c-99e7-626d28367686.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,>= 750 mg/kg bw/day,,rat "Alcohols, C8-10, ethoxylated, sulfates, ammonium salts",68891-29-2,"Oral LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute oral toxicity in the Alkyl Ether Sulfates (AES) category in a weight of evidence approach.   Inhalation No information required according to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, as data on acute oral and acute dermal toxicity are provided.   Dermal LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute dermal toxicity in the AES category in a weight of evidence approach. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1f21b72-ca2e-4a26-ae11-ea527b5ca853/documents/e06b171a-8196-4a00-9c2c-18b1d6afea7e_ff43d4b2-358b-4d7c-99e7-626d28367686.html,,,,,, "Alcohols, C8-10, ethoxylated, sulfates, ammonium salts",68891-29-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1f21b72-ca2e-4a26-ae11-ea527b5ca853/documents/e06b171a-8196-4a00-9c2c-18b1d6afea7e_ff43d4b2-358b-4d7c-99e7-626d28367686.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alcohols, C8-10, ethoxylated, sulfates, ammonium salts",68891-29-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1f21b72-ca2e-4a26-ae11-ea527b5ca853/documents/e06b171a-8196-4a00-9c2c-18b1d6afea7e_ff43d4b2-358b-4d7c-99e7-626d28367686.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alcohols, C8-18, ethoxylated",157707-43-2," Data available for the closely related read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Alcohols, C8-18, ethoxylated(157707-43-2).The studies are as mentioned below: 1.In acute oral toxicity study, rats were treated with test chemicalorally.50% mortality was observedin treated rats at 2700mg/kg bw.Therefore, LD50 was considered to be 2700mg/kg bw,when rats were treated with test chemical orally.   2.In acute oral toxicity study, mice were treated with test chemical orally. No mortality was observedin treated mouse at 25000mg/kg bw.Therefore, LD50 was considered to be >25000mg/kg bw. When mouse were treated with test chemical orally.   Thus, based on the above summarised studies,Alcohols, C8-18, ethoxylated(157707-43-2) and it’s closely related read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,Alcohols, C8-18, ethoxylated(157707-43-2) cannot be classified for acute oral toxicity.Hence,based on the data available for the structurally similar and closely related read across chemical, Alcohols, C8-18, ethoxylated(157707-43-2)is not likely to be toxic atleast in the dose range of 2700->25000 mg/Kg bw.A ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ad150da-8e0f-4a76-a5b9-8faa20b8dc74/documents/dce7644d-ef4c-40b8-b7ca-3a096d7d5d63_d1b2ed5f-2dc3-403a-950f-167cb57fe2d5.html,,,,,, "Alcohols, C8-18, ethoxylated",157707-43-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ad150da-8e0f-4a76-a5b9-8faa20b8dc74/documents/dce7644d-ef4c-40b8-b7ca-3a096d7d5d63_d1b2ed5f-2dc3-403a-950f-167cb57fe2d5.html,,oral,LD50,"25,000 mg/kg bw",no adverse effect observed, "Alcohols, C9-11, branched and linear, ethoxylated",160901-09-7," Oral (subacute, rat, m/f, OECD 422): NOAEL (systemic toxicity) = 300 mg/kg bw/day Oral (subacute, rat, m/f, OECD 422): NOAEL (local toxicity) ≥ 1000 mg/kg bw/day   Oral (subchronic, rat, m/f, OECD 408): NOAEL (systemic toxicity) = 300 mg/kg bw/day Oral (subchronic, rat, m/f, OECD 408): NOAEL (local toxicity) = 300 mg/kg bw/day   Conclusion based on data obtained with alcohols, C9-11, branched and linear, ethoxylated (CAS No. 160901-09-7, EC No. 500-446-0) and considering all the available data on repeated dose toxicity in the Alcohol Ethoxylates (AE) category, in a Weight-of-Evidence approach. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/642c032e-8dd6-448f-af6e-0784b6b006aa/documents/IUC5-ae751109-5152-42c4-a2ce-f668a6fd386d_9407555a-8791-4a58-9015-215a44a6fa2e.html,,,,,, "Alcohols, C9-11, branched and linear, ethoxylated",160901-09-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/642c032e-8dd6-448f-af6e-0784b6b006aa/documents/IUC5-ae751109-5152-42c4-a2ce-f668a6fd386d_9407555a-8791-4a58-9015-215a44a6fa2e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Alcohols, C9-11, branched and linear, ethoxylated",160901-09-7," Oral: LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute oral toxicity in the Alcohol Ethoxylates (AE) category in a Weight-of-Evidence approach. Inhalation: No study required as the inhalation route of exposure is considered less relevant than the dermal route for AE substances. Dermal: According to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, no study is required as the AE substances do not meet the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/642c032e-8dd6-448f-af6e-0784b6b006aa/documents/62720914-7546-4412-ac6f-307a368b622f_9407555a-8791-4a58-9015-215a44a6fa2e.html,,,,,, "Alcohols, C9-11, branched and linear, ethoxylated",160901-09-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/642c032e-8dd6-448f-af6e-0784b6b006aa/documents/62720914-7546-4412-ac6f-307a368b622f_9407555a-8791-4a58-9015-215a44a6fa2e.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alcohols, C9-11, branched and linear, ethoxylated, sulfates, ammonium salts",160901-27-9," The assessment is based on the data currently available. New studies, based on the category review and the final decisions issued for some of the category substances, which are also relevant for this assessment, are currently being conducted. The hazard assessment with respect to repeated dose toxicity will be updated once all ongoing studies have been finalised. For the whole category of alcohol ethoxysulfates (AES) a oral NOAEL of 300 mg/kg bw/d was established. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d17b1e0-d693-4efd-9cd3-687cb96e0074/documents/IUC5-47ed0cfb-e217-46df-be69-f212c7f5c2ad_fa8b8c5e-1dc1-4c8f-8fa1-2a0a258bb118.html,,,,,, "Alcohols, C9-11, branched and linear, ethoxylated, sulfates, ammonium salts",160901-27-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d17b1e0-d693-4efd-9cd3-687cb96e0074/documents/IUC5-47ed0cfb-e217-46df-be69-f212c7f5c2ad_fa8b8c5e-1dc1-4c8f-8fa1-2a0a258bb118.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Alcohols, C9-11, branched and linear, ethoxylated, sulfates, ammonium salts",160901-27-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d17b1e0-d693-4efd-9cd3-687cb96e0074/documents/IUC5-47ed0cfb-e217-46df-be69-f212c7f5c2ad_fa8b8c5e-1dc1-4c8f-8fa1-2a0a258bb118.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,195 mg/kg bw/day,,mouse "Alcohols, C9-11, branched and linear, ethoxylated, sulfates, ammonium salts",160901-27-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d17b1e0-d693-4efd-9cd3-687cb96e0074/documents/IUC5-47ed0cfb-e217-46df-be69-f212c7f5c2ad_fa8b8c5e-1dc1-4c8f-8fa1-2a0a258bb118.html,Repeated dose toxicity – local effects,dermal,NOAEL,397 ,adverse effect observed, "Alcohols, C9-11, branched and linear, ethoxylated, sulfates, ammonium salts",160901-27-9,"Oral LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute oral toxicity in the Alkyl Ether Sulfates (AES) category in a Weight-of-Evidence approach.   Inhalation No information required according to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, as data on acute oral and acute dermal toxicity are provided.   Dermal LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute dermal toxicity in the AES category in a Weight-of-Evidence approach. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate and reliable (Klimisch score 1 and 2) studies from various source substances in the Alkyl Ether Sulfates (AES) category with similar structures and intrinsic properties. Read-across is justified based on common toxicokinetic behaviour and consistent trends in environmental fate, ecotoxicological and toxicological properties of the category member substances. The database of the AES category is thus sufficient to fulfil the standard information requirements set out in Annex VII, Section 8.5, in accordance with Annex XI, Section 1.5, of the REACH Regulation (EC) No. 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate and reliable (Klimisch score 1 and 2) studies from various source substances in the Alkyl Ether Sulfates (AES) category with similar structures and intrinsic properties. Read-across is justified based on common toxicokinetic behaviour and consistent trends in environmental fate, ecotoxicological and toxicological properties of the category member substances. The database of the AES category is thus sufficient to fulfil the standard information requirements set out in Annex VIII, Section 8.5, in accordance with Annex XI, Section 1.5, of the REACH Regulation (EC) No. 1907/2006. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d17b1e0-d693-4efd-9cd3-687cb96e0074/documents/IUC5-ee368787-b730-41c5-9e67-627d5dab35d2_fa8b8c5e-1dc1-4c8f-8fa1-2a0a258bb118.html,,,,,, "Alcohols, C9-11, branched and linear, ethoxylated, sulfates, ammonium salts",160901-27-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d17b1e0-d693-4efd-9cd3-687cb96e0074/documents/IUC5-ee368787-b730-41c5-9e67-627d5dab35d2_fa8b8c5e-1dc1-4c8f-8fa1-2a0a258bb118.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alcohols, C9-11, branched and linear, ethoxylated, sulfates, ammonium salts",160901-27-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d17b1e0-d693-4efd-9cd3-687cb96e0074/documents/IUC5-ee368787-b730-41c5-9e67-627d5dab35d2_fa8b8c5e-1dc1-4c8f-8fa1-2a0a258bb118.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alcohols, C9-11, branched and linear, ethoxylated, sulfates, sodium salts",160901-28-0," The assessment is based on the data currently available. New studies, based on the category review and the final decisions issued for some of the category substances, which are also relevant for this assessment, are currently being conducted. The hazard assessment with respect to repeated dose toxicity will be updated once all ongoing studies have been finalised. For the whole category of alcohol ethoxysulfates (AES) an oral NOAEL of 300 mg/kg bw/d was established. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08907a36-1a9d-4a30-9872-3b49a618b04b/documents/IUC5-ecfaa17d-c016-4342-83ad-19270599d452_1d1ee954-bd1c-4e43-b8c9-8a4ba5ccbd96.html,,,,,, "Alcohols, C9-11, branched and linear, ethoxylated, sulfates, sodium salts",160901-28-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08907a36-1a9d-4a30-9872-3b49a618b04b/documents/IUC5-ecfaa17d-c016-4342-83ad-19270599d452_1d1ee954-bd1c-4e43-b8c9-8a4ba5ccbd96.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Alcohols, C9-11, branched and linear, ethoxylated, sulfates, sodium salts",160901-28-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08907a36-1a9d-4a30-9872-3b49a618b04b/documents/IUC5-ecfaa17d-c016-4342-83ad-19270599d452_1d1ee954-bd1c-4e43-b8c9-8a4ba5ccbd96.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,195 mg/kg bw/day,,mouse "Alcohols, C9-11, branched and linear, ethoxylated, sulfates, sodium salts",160901-28-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08907a36-1a9d-4a30-9872-3b49a618b04b/documents/IUC5-ecfaa17d-c016-4342-83ad-19270599d452_1d1ee954-bd1c-4e43-b8c9-8a4ba5ccbd96.html,Repeated dose toxicity – local effects,dermal,NOAEL,397 ,adverse effect observed, "Alcohols, C9-11, branched and linear, ethoxylated, sulfates, sodium salts",160901-28-0,"Oral LD50 > 2000 mg/kg bw Conclusion based on data with alcohols, C9-11, branched and linear, ethoxylated, sulfates, sodium salts (CAS No. 160901-28-0, EC No. 500-465-4) and considering all available data on acute oral toxicity in the Alkyl Ether Sulfate (AES) category in a Weight-of-Evidence approach.   Inhalation No information required according to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, as data on acute oral and acute dermal toxicity are provided.   Dermal LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute dermal toxicity in the AES category in a Weight-of-Evidence approach. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate and reliable (Klimisch score 1 and 2) studies from various source substances in the Alkyl Ether Sulfates (AES) category with similar structures and intrinsic properties, incl. the registered substance. Read-across is justified based on common toxicokinetic behaviour and consistent trends in environmental fate, ecotoxicological and toxicological properties of the category member substances. The database of the AES category is thus sufficient to fulfil the standard information requirements set out in Annex VII, Section 8.5, in accordance with Annex XI, Section 1.5, of the REACH Regulation (EC) No. 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate and reliable (Klimisch score 1 and 2) studies from various source substances in the Alkyl Ether Sulfates (AES) category with similar structures and intrinsic properties. Read-across is justified based on common toxicokinetic behaviour and consistent trends in environmental fate, ecotoxicological and toxicological properties of the category member substances. The database of the AES category is thus sufficient to fulfil the standard information requirements set out in Annex VVII, Section 8.5, in accordance with Annex XI, Section 1.5, of the REACH Regulation (EC) No. 1907/2006. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08907a36-1a9d-4a30-9872-3b49a618b04b/documents/IUC5-657d4bdc-0489-40c4-b6e4-f119c6bce2ab_1d1ee954-bd1c-4e43-b8c9-8a4ba5ccbd96.html,,,,,, "Alcohols, C9-11, branched and linear, ethoxylated, sulfates, sodium salts",160901-28-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08907a36-1a9d-4a30-9872-3b49a618b04b/documents/IUC5-657d4bdc-0489-40c4-b6e4-f119c6bce2ab_1d1ee954-bd1c-4e43-b8c9-8a4ba5ccbd96.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alcohols, C9-11, branched and linear, ethoxylated, sulfates, sodium salts",160901-28-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08907a36-1a9d-4a30-9872-3b49a618b04b/documents/IUC5-657d4bdc-0489-40c4-b6e4-f119c6bce2ab_1d1ee954-bd1c-4e43-b8c9-8a4ba5ccbd96.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alcohols, C9-11-branched and linear",85711-26-8," There are no repeated dose toxicity data for the registration substance Alcohols, C9-11-branched and linear. Therefore, key data for the Category member hexan-1-ol have been used for this endpoint. A read across from a reliable 13-week dietary study in rats using hexan-1-ol reported a NOAEL of 1127 mg/kg bw/day (Scientific Associates Inc., 1966). The results of this key study are supported by a reliable 3-week feeding study in rats using hexan-1-ol which reported a NOAEL of approximately 1000 mg/kg bw/day (Moody, 1978 ). In addition a 90-day repeated dose dermal study (Wil Research, 1995) in rats, where a multi-constituent solution containing circa 50% decan-1-ol and circa 45% octan-1-ol (semi-occluded conditions) reported no systemic effects at the highest dose tested. The study did however give rise to marked dermal irritative effect. It is however important to take into account the different test protocol that was used, that is a 90-day repeated dose dermal study (6 hours/day for 5 days/week) compared to a standard 4-hour dermal irritation study and the different species (rats instead of rabbit) and test duration (90 days vs. 4 hours). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9362cb01-a158-4a97-90f6-d3fcde5ff16f/documents/d472ed14-46dc-4223-aec5-f99b5c539818_55014156-d091-4978-bdce-afafb9d319d5.html,,,,,, "Alcohols, C9-11-branched and linear",85711-26-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9362cb01-a158-4a97-90f6-d3fcde5ff16f/documents/d472ed14-46dc-4223-aec5-f99b5c539818_55014156-d091-4978-bdce-afafb9d319d5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,127 mg/kg bw/day",,rat "Alcohols, C9-11-branched and linear",85711-26-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9362cb01-a158-4a97-90f6-d3fcde5ff16f/documents/d472ed14-46dc-4223-aec5-f99b5c539818_55014156-d091-4978-bdce-afafb9d319d5.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Alcohols, C9-11-branched and linear",85711-26-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9362cb01-a158-4a97-90f6-d3fcde5ff16f/documents/d472ed14-46dc-4223-aec5-f99b5c539818_55014156-d091-4978-bdce-afafb9d319d5.html,Repeated dose toxicity – local effects,dermal,NOAEL,2.8 mg/cm2,adverse effect observed,rat "Alcohols, C9-11-branched and linear",85711-26-8," There are acute oral and dermal toxicity studies for Alcohols, C9-11 branched and linear. There is no acute inhalation toxicity study for Alcohols, C9-11 branched and linear, therefore the key acute inhalation toxicity study is read-across from Alcohols, C9-11. The key acute oral toxicity study for Alcohols, C9-11 branched and linear, conducted according to a protocol similar to the now-deleted OECD Test Guideline 401 and in compliance with GLP, reports an LD50 value of >4000 mg/kg bw (Albert, 1981a; rel 1). The key acute dermal toxicity study for Alcohols, C9-11 branched and linear, conducted according to a protocol similar to OECD Test Guideline 402 and in compliance with GLP, reports an LD50 value of >1660 mg/kg (Albert 1981b; rel 1). The key acute inhalation toxicity study for the analogue Alcohols, C9-11, conducted according to a protocol similar to OECD Test Guideline 403, but without information on GLP compliance, reports an LC50 value of >0.237  mg/l following 4-hour inhalation exposure to the vapour of Alcohols, C9-11 (Blair 1981; rel 2). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9362cb01-a158-4a97-90f6-d3fcde5ff16f/documents/40fa568d-6342-4125-82b1-d9f60fc77ce5_55014156-d091-4978-bdce-afafb9d319d5.html,,,,,, "Alcohols, C9-11-branched and linear",85711-26-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9362cb01-a158-4a97-90f6-d3fcde5ff16f/documents/40fa568d-6342-4125-82b1-d9f60fc77ce5_55014156-d091-4978-bdce-afafb9d319d5.html,,oral,LD50,"4,000 mg/kg bw",no adverse effect observed, "Alcohols, C9-11-branched and linear",85711-26-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9362cb01-a158-4a97-90f6-d3fcde5ff16f/documents/40fa568d-6342-4125-82b1-d9f60fc77ce5_55014156-d091-4978-bdce-afafb9d319d5.html,,dermal,LD50,"1,660 mg/kg bw",no adverse effect observed, "Alcohols, C9-11-branched and linear",85711-26-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9362cb01-a158-4a97-90f6-d3fcde5ff16f/documents/40fa568d-6342-4125-82b1-d9f60fc77ce5_55014156-d091-4978-bdce-afafb9d319d5.html,,inhalation,LC50,"2,370 mg/m3",no adverse effect observed, "Alcohols, C9-11-iso-, C10-rich",68526-85-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eaa47746-0302-4e6d-871a-76d8c374a4fd/documents/IUC5-bdb3633c-7da3-493b-a5c4-9ee9ee2689a1_3efc885a-41e6-4873-88d3-acaee79084f7.html,,oral,LD50,"2,648 mg/kg bw",, "Alcohols, C9-11-iso-, C10-rich",68526-85-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eaa47746-0302-4e6d-871a-76d8c374a4fd/documents/IUC5-bdb3633c-7da3-493b-a5c4-9ee9ee2689a1_3efc885a-41e6-4873-88d3-acaee79084f7.html,,dermal,LD50,"3,160 mg/kg bw",, "Alcohols, lanolin, distn. residues",90622-40-5,"Based on read-across from Alcohols, lanolin (CAS No. 8027-33-6):Oral: LD50 (rat, m/f) > 2000 mg/kg bw (OECD 401, GLP)Dermal: LD50 (rat, m/f) > 2000 mg/kg bw (OECD 402, GLP) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef11bb18-f7c8-45a6-867b-45f7a226a8e2/documents/IUC5-1a7110ec-0a70-4d1f-8af7-253aea8dce75_5f54d787-faac-4ee2-8164-25dac554a576.html,,,,,, "Alkanes, C14-17",90622-47-2,Tetradecane: LD50 > 5000 mg/kg bwParaffin wax: LD50 > 5000 mg/kg bwC12-14-Paraffin: LD50 > 5000 mg/kg bwC10-13-Paraffin: LD50 > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4916c103-2e3f-4127-b33d-204ede2ad43f/documents/IUC5-9f0f071c-a1a5-4175-a033-034478d41078_2400a955-8757-4159-87ce-01607dcdb0d3.html,,,,,, "Alkanes, C14-17",90622-47-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4916c103-2e3f-4127-b33d-204ede2ad43f/documents/IUC5-9f0f071c-a1a5-4175-a033-034478d41078_2400a955-8757-4159-87ce-01607dcdb0d3.html,,oral,LD50,"5,000 mg/kg bw",, "Alkanes, C14-17, chloro",85535-85-9,"A number of studies have investigated the repeated dose oral toxicity of C14-17 chlorinated paraffins (40% or 52% chlorination) in rodents. These allow identification of an overall NOAEL of 23 mg/kg bw/day, from a 90-day dietary study in rats. Increased kidney and liver weights, liver enzyme induction, liver hypertrophy and slight decreases in plasma triglycerides and cholesterol levels were seen at the next higher dose of 222 mg/kg bw/day. At even higher doses in other 90-day rat dietary studies, additional kidney effects (‘chronic nephritis’ and tubular pigmentation) were reported as well as effects on the liver and thyroid. The liver effects included enzyme induction, increased weight and hypertrophy (all considered to be adaptive responses rather than toxicological in nature) and signs of peroxisome proliferation (of no relevance to man). The thyroid effects were concluded to be secondary to changes in liver enzyme activity and of no real significance for humans. In one-generation reproduction studies, NOAELs of 47 mg/kg bw/day and 100 mg/kg bw/day (as maternal doses) have been identified for the adverse effects on blood clotting seen in the offspring mediated via lactation and for the haemorrhaging potential in dams at parturition, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/378a8fc8-e750-486b-b49b-88e3609810e5/documents/0cf10a06-13b6-4956-957e-766c788fde48_d40282ea-8ee3-434d-847d-95d1bdf37996.html,,,,,, "Alkanes, C14-17, chloro",85535-85-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/378a8fc8-e750-486b-b49b-88e3609810e5/documents/0cf10a06-13b6-4956-957e-766c788fde48_d40282ea-8ee3-434d-847d-95d1bdf37996.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,23 mg/kg bw/day,,rat "Alkanes, C14-17, chloro",85535-85-9,"No deaths or other severe adverse affects were reported in a number of acute oral studies, in which rats were given single doses of C14-17 chlorinated paraffins (40-61% chlorination; with or without 0.2-1% epoxy stabiliser) of up to 15 g/kg bw by stomach tube. There are no acute inhalation or dermal exposure studies on MCCPs available in laboratory animals. However, based upon animal data for SCCPs, and supported by the low toxicity of C14-17 chlorinated paraffins via the oral route, it is predicted that the MCCPs are also likely to be of low acute inhalation and dermal toxicity. No acute human data is available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/378a8fc8-e750-486b-b49b-88e3609810e5/documents/b97d462e-71ba-460f-a387-04d200a2e1ff_d40282ea-8ee3-434d-847d-95d1bdf37996.html,,,,,, "Alkanes, C16-47, branched and linear",2133415-29-7," No key or supporting data is available for the registered substance. However, key repeated dose oral toxicity data in rats is available from a structurally related substance, C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) and is presented below: 90 day repeated dose oral toxicity study in the rat: - treatment-related effects in animals of either sex treated with 1000 and 200 mg/Kg/day - no such effects were detected in animals of either sex treated with 50 mg/Kg/day and the “No Observed Effect Level” (NOEL) was, therefore, considered to be 50 mg/Kg/day. - the effects detected at 200 and 1000 mg/Kg/day in the lungs and mesenteric lymph nodes were considered to be secondary to aspiration following the oral gavage and a normal response of the lymph nodes clearing the material, respectively, and were therefore not considered to be an adverse effect of treatment; the “No Observed Adverse Effect Level” (NOAEL) was therefore considered to be 1000 mg/Kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5542d39a-630c-4648-b23c-ba51478312f9/documents/7f87af79-76a2-46f6-9878-4ea6eb8e10f6_4ec206fe-ceec-4932-8212-5b0e79be9718.html,,,,,, "Alkanes, C16-47, branched and linear",2133415-29-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5542d39a-630c-4648-b23c-ba51478312f9/documents/7f87af79-76a2-46f6-9878-4ea6eb8e10f6_4ec206fe-ceec-4932-8212-5b0e79be9718.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Alkanes, C16-47, branched and linear",2133415-29-7," No acute oral, dermal, or inhalation toxicity data is available for the registered substance. However, key oral toxicity and supporting dermal and inhalation toxicity data is available from structurally related substances, C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) and C8-C26 branched and linear hydrocarbons – Distillates (CAS# 848301-67-7) and is presented below. 1) Acute oral toxicity: The acute oral median lethal dose (LD50) of C18-C50 branched, cyclic and linear hydrocarbons – Distillates (CAS# 848301-69-9) in the female Sprague-Dawley CD strain rat was estimated to be greater than 5000 mg/kg bodyweight. 2) Acute inhalation and dermal toxicity: Based on lack of skin irritation and systemic effects in a read across skin irritation study, the registered substance is not considered to be acutely harmful in contact with skin. Moreover, the substance is unlikely to form aerosols or particles of inhalable size. Therefore it is considered justifiable not to conduct these studies. Supporting data on a related substance C8-C26 branched and linear hydrocarbons – Distillates (CAS# 848301-67-7) indicate the low dermal and inhalation toxicity: a) Acute inhalation toxicity study (Shell, 2013a), conducted according to OECD 436 and GLP, reported an acute inhalation median lethal concentration (4 hr LC50) of Distillates (Fischer-Tropsch), C8-26-branched and linear, in the RccHanTM: WIST strain rat >5 mg/L. b) Acute dermal toxicity study (Shell, 2015a), conducted according to OECD 402 (Acute Dermal Toxicity) and GLP, reported an LD50 in male and female rats >2000 mg/Kg bw. The above data is used for read across to Alkanes, C16 -47, branched and linear. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5542d39a-630c-4648-b23c-ba51478312f9/documents/effddcb4-7bd2-47ee-82db-5f3c34fe706a_4ec206fe-ceec-4932-8212-5b0e79be9718.html,,,,,, "Alkanes, C16-47, branched and linear",2133415-29-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5542d39a-630c-4648-b23c-ba51478312f9/documents/effddcb4-7bd2-47ee-82db-5f3c34fe706a_4ec206fe-ceec-4932-8212-5b0e79be9718.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Alkanes, C16-47, branched and linear",2133415-29-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5542d39a-630c-4648-b23c-ba51478312f9/documents/effddcb4-7bd2-47ee-82db-5f3c34fe706a_4ec206fe-ceec-4932-8212-5b0e79be9718.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Alkanes, C16-47, branched and linear",2133415-29-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5542d39a-630c-4648-b23c-ba51478312f9/documents/effddcb4-7bd2-47ee-82db-5f3c34fe706a_4ec206fe-ceec-4932-8212-5b0e79be9718.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Alkenes, C>8",68411-00-7,"Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available.For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members. The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3). The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1864451b-6e4c-4f82-87df-9fd7e8322a63/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_b39c3319-ca91-4a42-b314-a7bdbb9a828c.html,,,,,, "Alkenes, C>8",68411-00-7,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1864451b-6e4c-4f82-87df-9fd7e8322a63/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_b39c3319-ca91-4a42-b314-a7bdbb9a828c.html,,,,,, "Alkenes, C10-13",85535-87-1,"Twenty-eight day oral repeated dose toxicity studies (OECD 407) from alkenes, C16-18 alkenes and alkenes, C20-24 were identified. Additionally, a 42-53 day oral screening study with alkenes, C6 (OECD 422) was identified. A 90-day oral study from alkenes, C20-24 (OECD 408) was identified. A 90-day inhalation study (OECD 413) with hex-1-ene was identified and used for read across. There were no key dermal repeated dose studies identified.The 28-day oral toxicity study with alkenes, C16-18 found no significant treatment related signs of toxicity or mortality; the reported NOAEL for Amodrill 1000 was 1000 mg/kg/day. The 28-day oral toxicity study with alkenes, C20-24 found no significant treatment related signs of toxicity or mortality; the reported NOAEL for ENDORDET O241 was 1000 mg/kg/day. A combined repeated dose/reproduction/developmental toxicity study on hex-1-ene found no significant findings among treated animals compared with controls. Mild hyaline droplet nephropathy was observed in males in the 1000 mg/kg bw group, however this was not considered toxicologically relevant to humans. The 90-day oral toxicity study with alkenes, C20-24 found no significant treatment related signs of toxicity or mortality; the reported NOAEL was 1000 mg/kg/day. For the read-across 90-day inhalation study from hex-1-ene, no relevant adverse effects were observed at the highest dose tested (3000 ppm corresponding with 10.3 mg/L hex-1-ene).DNELs were not derived for multiple carbon number isomerised olefins because no adverse findings relevant to human health risk assessment were found in the studies summarised above. These results indicate that multiple carbon number isomerised olefins, as a class, possess an inherently low hazard potential with regard to human health. Therefore, derivation of DNELs is unnecessary. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9f79322-fc7a-40ae-baf0-338c405ef371/documents/IUC5-7fb3450d-8624-4628-99f3-aeaa15d1987b_7688552f-66cc-4f1f-8b88-3e0460be95bf.html,,,,,, "Alkenes, C10-13",85535-87-1,"There are no acute oral, inhalation, or dermal toxicity studies on alkenes, C10-13. Read-across studies from alkenes, C11-15 and hydrocarbons C14-30, olefin-rich (non-guideline and 16 CFR 15003, respectively) were identified for acute oral toxicity. In addition, a read-across studies from alkenes, C20-24 (OECD 420) and alkenes, C24-28 (OECD 401) were identified for acute oral toxicity. Read-across studies from alkenes, C11-15 and hydrocarbons C14-30, olefin-rich were identified for acute dermal (non-guideline and OECD 402, respectively) toxicity. In addition, a read-across study from alkenes, C24-28 was identified for actue oral toxicity (OECD 401). Read-across data from alkenes, C10/C11/C12/C13 (OECD 403; isomerised olefins; alpha, internal, linear and branched – multiple carbon numbers), hex-1-ene (OECD 403; linear alpha olefin), and hexadec-1-ene (OECD 403; linear alpha olefin) were used for acute inhalatory toxicity.• The oral LD50 was > 10 mL/kg in female rats (i.e., > 7600 mg/kg) and 10 mL/kg (7600 mg/kg) in male rats for alkenes, C11-15.• The oral LD50 was > 10,000 mg/kg in male and female rats for hydrocarbons C14-30, olefin-rich.• The oral LD50 was > 2000 mg/kg in female rats for alkenes, C20-24.• The oral LD50 was > 5000 mg/kg in male and female rats for alkenes, C24-28.• The dermal LD50 was > 4 mL/kg (i.e., 3040 mg/kg) in female rabbits and between 2 and 4 mL/kg (i.e., 1520 to 3040 mg/kg) in male rabbits for alkenes, C11-15.• The dermal LD50 was > 10,000 mg/kg in male and female rabbits for hydrocarbons C14-30, olefin-rich.• The LC50 was > 2100 mg/m3 (2.1 mg/L) in rats for alkenes, C10/C11/C12/C13.• The LC50 was 110,148 mg/m3 (110.1 mg/L) in male rats for hex-1-ene.• The LC50 was ≥ 8500 mg/m3 (8.5 mg/L)in male rats for hexadec-1-ene. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9f79322-fc7a-40ae-baf0-338c405ef371/documents/IUC5-2b91846e-2f82-452c-9795-b6661d5ae79e_7688552f-66cc-4f1f-8b88-3e0460be95bf.html,,,,,, "Alkenes, C10-14",85681-75-0," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/424a2584-397e-4a76-8ac2-13bb04401e1f/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_7d074d2c-ebd4-4fab-885c-a5677b6320af.html,,,,,, "Alkenes, C10-14",85681-75-0,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/424a2584-397e-4a76-8ac2-13bb04401e1f/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_7d074d2c-ebd4-4fab-885c-a5677b6320af.html,,,,,, "Alkenes, C10-14-branched and linear, C12-rich",93821-12-6," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f746ab77-369c-4ae1-8951-373631c6cc73/documents/f1778ac0-3885-4b64-a7a1-493f7d5a1e2a_7da4121b-b5d2-4ae2-a157-8a8e9ada010b.html,,,,,, "Alkenes, C10-14-branched and linear, C12-rich",93821-12-6,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f746ab77-369c-4ae1-8951-373631c6cc73/documents/e3ca3984-a9e9-42ab-9c51-d4f7559f2ba1_7da4121b-b5d2-4ae2-a157-8a8e9ada010b.html,,,,,, "Alkenes, C11-12, hydroformylation products, distn. residues",90622-27-8,Well conducted OECD 408 guideline study conducted according to GLP. NOAEL considered to be 1000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4076d461-4493-400a-ab43-61733323e368/documents/IUC5-282188e2-f438-4a9f-8543-6bcff211629c_a8e84836-15f2-4a82-844f-4e461d9b8fac.html,,,,,, "Alkenes, C11-12, hydroformylation products, distn. residues",90622-27-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4076d461-4493-400a-ab43-61733323e368/documents/IUC5-282188e2-f438-4a9f-8543-6bcff211629c_a8e84836-15f2-4a82-844f-4e461d9b8fac.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat "Alkenes, C13-14, hydroformylation products, distn. residues",90622-29-0,"In a repeated dose toxicity oral gavage study (OECD 408), Han Wistar rats were administed the Test Material Alkenes, C13-C14, hydroformylation products, distn. Residues (CAS No. 90622-29-0) once daily for 90 consecutive days via oral gavage at levels of 100, 300 and 1000 mg/kg bw/day. Based on the results, due to reversible changes in the liver weights in males and females, the no-observed-adverse-effect level (NOAEL) was considered to be great or equal to 1000 mg/kg bw/day. In addition, a combined repeated dose toxicity studies with the reproductive/developmental screening test (OECD 422, see Section 7.8.1) was conducted with Alkenes, C13-C14, hydroformylation products, distn. Residues. The test material was administered by oral gavage to male and female Crl:WI(Han) rats at 0, 100, 300 or 1000 mg/kg bw/day in 0.5% HPMC (Methocel E4M) + 0.1% Tween 80 in Elix water for a minimum of 28 days. In this study there were no adverse findings and the NOAEL for systemic toxicity was set at 1000 mg/kg bw/day for males and females. Therefore, it is concluded that Alkenes, C13-C14, hydroformylation products, distn. Residues is unlikely to cause adverse effects after repeated exposure and no classification is required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9907a1d-dfa4-4ba7-bfc5-63eb1923ba89/documents/IUC5-f66f8ec2-da9e-484e-9360-7fee35af7bad_f5a4db22-13d5-4fd6-b408-6f513a5112d0.html,,,,,, "Alkenes, C13-14, hydroformylation products, distn. residues",90622-29-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9907a1d-dfa4-4ba7-bfc5-63eb1923ba89/documents/IUC5-f66f8ec2-da9e-484e-9360-7fee35af7bad_f5a4db22-13d5-4fd6-b408-6f513a5112d0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat "Alkenes, C13-14, hydroformylation products, distn. residues",90622-29-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9907a1d-dfa4-4ba7-bfc5-63eb1923ba89/documents/IUC5-823e9b2c-21e3-4342-80c3-81f4b69ed70f_f5a4db22-13d5-4fd6-b408-6f513a5112d0.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Alkenes, C13-14, hydroformylation products, distn. residues",90622-29-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9907a1d-dfa4-4ba7-bfc5-63eb1923ba89/documents/IUC5-823e9b2c-21e3-4342-80c3-81f4b69ed70f_f5a4db22-13d5-4fd6-b408-6f513a5112d0.html,,dermal,LD50,"> 2,020 mg/kg bw",no adverse effect observed, "Alkenes, C15-18",93762-80-2," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f3d7d5e-8bca-4e09-aa32-8450879600df/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_3721dab5-e9ca-4c9d-932e-7470942792eb.html,,,,,, "Alkenes, C15-18",93762-80-2,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f3d7d5e-8bca-4e09-aa32-8450879600df/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_3721dab5-e9ca-4c9d-932e-7470942792eb.html,,,,,, "Alkenes, C15-18 α-, sulfurized",67762-55-4,REPEATED DOSE TOXICITY: ORALNOAEL 1000 mg/kg/day for male and female Wistar Han rats ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d32656d8-ec0b-4bff-9b8b-2e62dc7bc37c/documents/IUC5-ca5dcc03-49b8-4afd-9cba-02dac8c561f8_5dec1fd6-17ce-4e9e-a1c5-68447f351190.html,,,,,, "Alkenes, C15-18 α-, sulfurized",67762-55-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d32656d8-ec0b-4bff-9b8b-2e62dc7bc37c/documents/IUC5-ca5dcc03-49b8-4afd-9cba-02dac8c561f8_5dec1fd6-17ce-4e9e-a1c5-68447f351190.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Alkenes, C15-18 α-, sulfurized",67762-55-4,ACUTE TOXICITY: ORAL- LD50 >2000 mg/kg bodyweight to female Wistar strain ratsACUTE TOXICITY: DERMAL- LD50 >2000 mg/kg bodyweight to male and female New Zealand White rabbits ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d32656d8-ec0b-4bff-9b8b-2e62dc7bc37c/documents/IUC5-0e3ffa35-681f-4e29-bac3-a5267a8550a5_5dec1fd6-17ce-4e9e-a1c5-68447f351190.html,,,,,, "Alkenes, C6-10, hydroformylation products, high-boiling",68526-82-9,"Repeated Dose Toxicity – Oral NOAEL 1000 mg/kg (OECD TG 417) highest dose tested, no adverse effects. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a993206-659f-4493-8766-3cac341d0ec4/documents/IUC5-4b58d481-9534-4628-878a-804ba9384da7_6809957b-49a5-4cfe-b203-9c7794c51226.html,,,,,, "Alkenes, C6-10, hydroformylation products, high-boiling",68526-82-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a993206-659f-4493-8766-3cac341d0ec4/documents/IUC5-4b58d481-9534-4628-878a-804ba9384da7_6809957b-49a5-4cfe-b203-9c7794c51226.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, "Alkenes, C6-10, hydroformylation products, high-boiling",68526-82-9,Acute Toxicity – Oral LD50 >5000 mg/kg for rat (OECD TG 420). ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a993206-659f-4493-8766-3cac341d0ec4/documents/IUC5-ba2e4b4b-6dc6-46b5-9e2f-2aa6207e6a6c_6809957b-49a5-4cfe-b203-9c7794c51226.html,,,,,, "Alkenes, C6-8-branched, C7-rich",97592-99-9," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be30b111-597d-4a23-ace7-0c4fd10f244d/documents/f1778ac0-3885-4b64-a7a1-493f7d5a1e2a_fab5a9ad-3406-422d-8ebb-dcb87fbf02d5.html,,,,,, "Alkenes, C6-8-branched, C7-rich",97592-99-9,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be30b111-597d-4a23-ace7-0c4fd10f244d/documents/e3ca3984-a9e9-42ab-9c51-d4f7559f2ba1_fab5a9ad-3406-422d-8ebb-dcb87fbf02d5.html,,,,,, "Alkenes, C7-9-branched, C8-rich",97593-00-5," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9eb2ea78-67ea-444b-8120-5b43ec701174/documents/f1778ac0-3885-4b64-a7a1-493f7d5a1e2a_807413bf-3369-42d6-8cd9-62375dfef14c.html,,,,,, "Alkenes, C7-9-branched, C8-rich",97593-00-5,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9eb2ea78-67ea-444b-8120-5b43ec701174/documents/e3ca3984-a9e9-42ab-9c51-d4f7559f2ba1_807413bf-3369-42d6-8cd9-62375dfef14c.html,,,,,, "Alkenes, C8-10, C9-rich",68526-55-6," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d45c1b39-4d44-4621-846b-985de3d79e6a/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_9ee4f50a-cc5d-4293-a0bf-c48ab21abd88.html,,,,,, "Alkenes, C8-10, C9-rich",68526-55-6,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d45c1b39-4d44-4621-846b-985de3d79e6a/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_9ee4f50a-cc5d-4293-a0bf-c48ab21abd88.html,,,,,, "Alkenes, C8-10-branched, C9-rich",97593-01-6," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/839c4067-fa0e-48fd-b868-4aa5df02abce/documents/f1778ac0-3885-4b64-a7a1-493f7d5a1e2a_87b3974d-28f7-4c85-8705-d5d5006ed0af.html,,,,,, "Alkenes, C8-10-branched, C9-rich",97593-01-6,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/839c4067-fa0e-48fd-b868-4aa5df02abce/documents/e3ca3984-a9e9-42ab-9c51-d4f7559f2ba1_87b3974d-28f7-4c85-8705-d5d5006ed0af.html,,,,,, "Alkenes, C9-11, C10-rich",68526-56-7," This category of UVCB substances (streams) are generally made by similar manufacturing processes involving steam cracking. Consequently, they have many of the same constituents within the stream compositions. The proportion of these constituents will vary. The major groups of constituents within the resin oils and cyclic dienes are unsaturated non-hydrotreated products (the resin oil products) dicyclopentadiene (DCPD) and methylcyclopentadiene-cyclopentadiene; as well as indane and indene. These streams may also have variable concentrations of aromatics, including benzene, styrene, toluene, xylenes and naphthalene. These notable mono-constituents are referred to as the “marker substances”. See the Category Justification Document (CJD) attached in Section 13.2 for full detail. To support the category approach adopted by LOA for these UVCB streams, coherence and read-across between the UVCBs in the category, the following approaches were taken: Full category coverage of UVCB streams and marker substances. UVCB streams have been coded L-01 to L-12, and the marker substances that were considered toxicologically relevant were benzene, xylene, naphthalene, DCPD, cyclohexane, indene, ethylbenzene, toluene and styrene. All of these UVCB streams and markers (except ethylbenzene, toluene and styrene) were evaluated in a 14-day repeated-dose toxicity study, according to the parameters of the OECD 407 repeated-dose oral toxicity study in rodents adopted October 2008. Additionally, terminal plasma was collected for metabolomic analysis. Metabolomics is a new approach methodology explored by LOA to determine whether the technology is useful to support complex UVCB category grouping and read-across. The doses for these studies were selected from 7-day dose-range finding studies conducted prior to the main studies. OECD 422 combined repeated-dose toxicity and reproduction/developmental toxicity screening studies on selected representative streams aimed at covering the compositional breadth of the category. To ensure efficient use of animals, the doses for these studies were selected based upon the results from the 14-day metabolomics studies. These data are supported by available 90-day repeated-dose toxicity studies (OECD 408) on marker substances. All of these data are summarised and discussed below in the “Additional Information” section ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/996920c2-d996-4c31-9b70-ee527c741d81/documents/90cf25de-7056-4043-883f-afcdf26aac53_270049de-d7c3-416f-a948-864b4fb766f1.html,,,,,, "Alkenes, C9-11, C10-rich",68526-56-7," Available data for 3 specific streams within this category: C9 Resinfeed [CAS 68477-54-3]; E000144700 [CAS 68516-20-1]; and C9 Produkt [CAS 94733-07-0] and on specific constituents (benzene, toluene, n-Hexane) that are present in some streams indicate that acute toxicity is generally expected to be low. Resin Oil and Cyclic Dienes do not pose an acute hazard following skin contact (dermal LD50 > 2000 mg/Kg). Two streams (E000044012 [CAS 68478-10-4], E000044146 [CAS 68478-10-4]) and the constituent dicyclopentadiene are considered to be hazardous following acute inhalation exposures. Streams containing a high proportion (≥ 25%) of dicyclopentadiene or naphthalene are expected to be hazardous following oral exposures. Styrene is hazardous following acute inhalation exposure and classification will be required for streams containing ≥ 25%. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and labelling will be required for streams containing ≥ 20% toluene. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/996920c2-d996-4c31-9b70-ee527c741d81/documents/54b66a95-cb8a-43b2-be0b-245e0fadc96f_270049de-d7c3-416f-a948-864b4fb766f1.html,,,,,, "Alkenes, C9-13-branched, C10-rich",91994-95-5," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f20f3ee2-cbcd-4a94-9add-9b1edb720cd4/documents/f1778ac0-3885-4b64-a7a1-493f7d5a1e2a_e8144bad-fabb-46c4-ac0d-a8682f7e279b.html,,,,,, "Alkenes, C9-13-branched, C10-rich",91994-95-5,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f20f3ee2-cbcd-4a94-9add-9b1edb720cd4/documents/e3ca3984-a9e9-42ab-9c51-d4f7559f2ba1_e8144bad-fabb-46c4-ac0d-a8682f7e279b.html,,,,,, Allyl 2-cyanoacrylate,7324-02-9,"REACH_LD50 > 5000 mg/kg bw | rat (male) | - | Ethylcyanoacrylate #Analogy# REACH_LD50 > 2000 mg/kg bw | rat (female) | Acute toxicity: oral allyl 2-cyanoacrylate (extract)#key study# All available data on ethyl 2-cyanoacrylate (ECA) indicate an absence of lethal effects after application of doses >2000 mg/kg body weight via the oral or dermal route. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): see additional information Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): See additional information ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68fcf501-94d9-493f-9ec6-9290fdb40067/documents/ae6f84f0-38c1-4ec3-93e3-dee7db3060be_90f441e7-2ade-4752-a989-2a8fa237fb51.html,,,,,, Allyl 2-cyanoacrylate,7324-02-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68fcf501-94d9-493f-9ec6-9290fdb40067/documents/ae6f84f0-38c1-4ec3-93e3-dee7db3060be_90f441e7-2ade-4752-a989-2a8fa237fb51.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Allyl acetoacetate,1118-84-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): The data is from European Union Risk assessment report Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The data is K2 level as the data has been obtained from QSAR model considered by OECD. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The data is K2 level as the data has been obtained from QSAR model considered by OECD. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/14569f62-b581-42b6-bc35-91995ad6c56d/documents/IUC5-784e3add-3551-4292-82ee-f9f03bdeb6ac_c92bf508-8718-4549-9e0a-97cae962b61c.html,,,,,, Allyl acetoacetate,1118-84-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/14569f62-b581-42b6-bc35-91995ad6c56d/documents/IUC5-784e3add-3551-4292-82ee-f9f03bdeb6ac_c92bf508-8718-4549-9e0a-97cae962b61c.html,Sub-chronic toxicity – systemic effects,dermal,,420 ,,other:human Allyl acetoacetate,1118-84-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The data is K2 level as the data has been obtained from QSAR model which is considered reliable by OECD. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The data is K2 level as the data has been obtained from QSAR model considered reliable by OECD. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The data is K2 level as the data has been obtained from authoritative sources. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14569f62-b581-42b6-bc35-91995ad6c56d/documents/IUC5-6b89ce8e-3410-4cd9-943c-8370e49cc81b_c92bf508-8718-4549-9e0a-97cae962b61c.html,,,,,, Allyl acetoacetate,1118-84-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14569f62-b581-42b6-bc35-91995ad6c56d/documents/IUC5-6b89ce8e-3410-4cd9-943c-8370e49cc81b_c92bf508-8718-4549-9e0a-97cae962b61c.html,,oral,LD50,562.732 mg/kg bw,adverse effect observed, Allyl acetoacetate,1118-84-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14569f62-b581-42b6-bc35-91995ad6c56d/documents/IUC5-6b89ce8e-3410-4cd9-943c-8370e49cc81b_c92bf508-8718-4549-9e0a-97cae962b61c.html,,dermal,LD50,530 mg/kg bw,adverse effect observed, Allyl acetoacetate,1118-84-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14569f62-b581-42b6-bc35-91995ad6c56d/documents/IUC5-6b89ce8e-3410-4cd9-943c-8370e49cc81b_c92bf508-8718-4549-9e0a-97cae962b61c.html,,inhalation,LC50,472.342 ,no adverse effect observed, Allyl alcohol,107-18-6,"Allyl alcohol has been tested in two reliable 90-day repeated dose studies via the oral route (rat and mouse) and one via the inhalation route (rat). The studies are considered adequate for assessment purpose and have been utilised for DNEL setting and consideration of classification and labelling in accordance with the CLP Regulation (EC No. 1272/2008, as adapted).  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf4d522d-9cea-46f3-ae49-b5f81d3b4503/documents/IUC5-40f220b5-98e1-45f5-af34-4a2f0c02ad5b_740ad225-f55c-40f2-889c-5a23800ac961.html,,,,,, Allyl alcohol,107-18-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf4d522d-9cea-46f3-ae49-b5f81d3b4503/documents/IUC5-40f220b5-98e1-45f5-af34-4a2f0c02ad5b_740ad225-f55c-40f2-889c-5a23800ac961.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,3 mg/kg bw/day,,rat Allyl alcohol,107-18-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf4d522d-9cea-46f3-ae49-b5f81d3b4503/documents/IUC5-40f220b5-98e1-45f5-af34-4a2f0c02ad5b_740ad225-f55c-40f2-889c-5a23800ac961.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,47.5 mg/m3,,rat Allyl alcohol,107-18-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf4d522d-9cea-46f3-ae49-b5f81d3b4503/documents/IUC5-ef39af50-391d-48bc-8050-44d968b8f1a6_740ad225-f55c-40f2-889c-5a23800ac961.html,,oral,LD50,99 mg/kg bw,adverse effect observed, Allyl alcohol,107-18-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf4d522d-9cea-46f3-ae49-b5f81d3b4503/documents/IUC5-ef39af50-391d-48bc-8050-44d968b8f1a6_740ad225-f55c-40f2-889c-5a23800ac961.html,,dermal,LD50,89 mg/kg bw,adverse effect observed, Allylamine,107-11-9," Exposure of Sprague-Dawley rats to Allylamine, using a snout-only inhalation exposure system, for 6 hours a day for 7 consecutive days at achieved aerosol concentrations of 11.9, 24.5 and 47.4 mg/m3 was well tolerated and did not result in any histopathological changes. Slight reductions in bodyweight gain when compared with control were evident for males from all allylamine exposed groups. A similar effect in females was not clear and the effect in males previously exposed to 47.4 mg/m3 was reversed following a 2 week off-exposure recovery period. The effect on bodyweight was thus not considered to be adverse over the duration of this study, but could potentially be so on a longer study. The No Observed Adverse Effect Concentration (NOAEC), is thus considered to be 47.4 mg/m3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dcf407e7-8613-421e-9f38-cc640a4dd501/documents/IUC5-fff563c9-eda7-46d2-8e7a-4a3becc7deae_1a0c65c6-fc97-4d13-bb02-46ccdb36385c.html,,,,,, Allylamine,107-11-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dcf407e7-8613-421e-9f38-cc640a4dd501/documents/IUC5-fff563c9-eda7-46d2-8e7a-4a3becc7deae_1a0c65c6-fc97-4d13-bb02-46ccdb36385c.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,47.4 mg/m3,,rat Allylamine,107-11-9," Oral LD50 = 57 mg/kg bw in mice (Hine, CH et al, 1960) Inhalation LC50  = 413 mg/m3, 8 hours in rats (Hine, CH et al, 1960) Dermal LD50 = 35 mg/kg in rats (Hine, CH et al, 1960) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcf407e7-8613-421e-9f38-cc640a4dd501/documents/IUC5-2bfa1644-c501-40af-8992-44d8943ee7af_1a0c65c6-fc97-4d13-bb02-46ccdb36385c.html,,,,,, Allylamine,107-11-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcf407e7-8613-421e-9f38-cc640a4dd501/documents/IUC5-2bfa1644-c501-40af-8992-44d8943ee7af_1a0c65c6-fc97-4d13-bb02-46ccdb36385c.html,,oral,LD50,57 mg/kg bw,adverse effect observed, Allylamine,107-11-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcf407e7-8613-421e-9f38-cc640a4dd501/documents/IUC5-2bfa1644-c501-40af-8992-44d8943ee7af_1a0c65c6-fc97-4d13-bb02-46ccdb36385c.html,,dermal,LD50,35 mg/kg bw,adverse effect observed, Allylamine,107-11-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcf407e7-8613-421e-9f38-cc640a4dd501/documents/IUC5-2bfa1644-c501-40af-8992-44d8943ee7af_1a0c65c6-fc97-4d13-bb02-46ccdb36385c.html,,inhalation,LC50,413.29 mg/m3,adverse effect observed, Allyltrimethylsilane,762-72-1,"Oral (OECD 420), rat: LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e3b6272-eb1d-47a0-9f8f-81b635353520/documents/492d9a7b-4153-46e3-96f3-06d9f3ad5269_a431f010-4cb1-4745-ae90-d60648f89b09.html,,,,,, Allyltrimethylsilane,762-72-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e3b6272-eb1d-47a0-9f8f-81b635353520/documents/492d9a7b-4153-46e3-96f3-06d9f3ad5269_a431f010-4cb1-4745-ae90-d60648f89b09.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Alpha,alpha-trehalaseIUBMB 3.2.1.28",9025-52-9," It is concluded that oral administration of trehalase, batch PPT42347 to Han Wistar rats at doses up to 100% of trehalase, batch PPT42347 for 13 weeks was well-tolerated and did not cause any adverse change. The no-observed adverse-effect level (NOAEL) was therefore considered to be 100% of the trehalase, batch PPT42347 (equivalent to 1312 mg TOS/kg body weight/day). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd6fb290-fc1c-460d-928b-8867144c5a2a/documents/86aa757f-6e39-49a6-afc2-ebb1cb55f522_39450a48-6f6e-432d-b294-50350412ae8e.html,,,,,, "Alpha,alpha-trehalaseIUBMB 3.2.1.28",9025-52-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd6fb290-fc1c-460d-928b-8867144c5a2a/documents/86aa757f-6e39-49a6-afc2-ebb1cb55f522_39450a48-6f6e-432d-b294-50350412ae8e.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,312 mg/kg bw/day",,rat "Alpha,alpha-trehalaseIUBMB 3.2.1.28",9025-52-9," The acute oral toxicity study for trehalase was not conducted, however, a 13-week oral toxicity repeated-dose toxicity study is available. Oral administration of trehalase, batch PPT42347 to Han Wistar rats at doses up to 100% of trehalase, batch PPT42347 for 13 weeks was well-tolerated and did not cause any adverse change. The no-observed adverse-effect level (NOAEL) was therefore considered to be 100% of the trehalase, batch PPT42347 (equivalent to 1312 mg TOS/kg body weight/day). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd6fb290-fc1c-460d-928b-8867144c5a2a/documents/5744f665-e62b-450d-96d7-c0cca3ef69f4_39450a48-6f6e-432d-b294-50350412ae8e.html,,,,,, Caesium tetrafluoroaluminate,39211-00-2, A NOAEL of 30 mg/kg bw/day was established in an oral 28-day repeated dose study in rats with the structural analogues cesium fluoro aluminate complex and cesium potassium fluoroaluminate. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d90a7dd4-62e1-4784-aafe-d1b82815ed9f/documents/IUC5-9d37bf62-259e-48c1-b0e2-980afc142138_06b7fcdc-41d1-4fbd-9895-dfaaded11f35.html,,,,,, Caesium tetrafluoroaluminate,39211-00-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d90a7dd4-62e1-4784-aafe-d1b82815ed9f/documents/IUC5-9d37bf62-259e-48c1-b0e2-980afc142138_06b7fcdc-41d1-4fbd-9895-dfaaded11f35.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat Caesium tetrafluoroaluminate,39211-00-2, The oral LD50 exceeds 2000 mg/kg body weight. The inhalatory LC50 (4 hours) was determined at 1 -5 mg/L for male and female rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d90a7dd4-62e1-4784-aafe-d1b82815ed9f/documents/IUC5-dab695f9-324f-40bd-9e71-e7ee89f6b291_06b7fcdc-41d1-4fbd-9895-dfaaded11f35.html,,,,,, Aluminium lanthanum trioxide,12003-65-5," Key studies and weight of evidence demonstrate a lack of potential for acute oral toxicity: Data are read-across based on grouping of substances, i.e. aluminium oxide, lanthanum oxide and aluminium lanthanum trioxide, based on inertness and similar solubility or lack thereof. Aluminium oxide and lanthanum trioxide are not acutely toxic via the oral route. Based on read-across (see category approach), it is assumed that aluminium lanthanum trioxide does not possess a potential for acute oral toxicity. ATE aluminium lanthanum trioxide = 3652 mg/kg bw (i.e. above the classification cut-off of 2000 mg/kg bw) Further, key studies with aluminium lanthanum trioxide demonstrate a lack of irritation/corrosion potential indicating also a low potential for local effects. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbebbab7-2706-4a5a-a0d2-c17caf211965/documents/d82bddd4-b125-4fd8-8c08-501769e4a1cf_ba83a3dc-e521-4375-b9e1-d867018d2918.html,,,,,, Aluminium lanthanum trioxide,12003-65-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbebbab7-2706-4a5a-a0d2-c17caf211965/documents/d82bddd4-b125-4fd8-8c08-501769e4a1cf_ba83a3dc-e521-4375-b9e1-d867018d2918.html,,oral,LD50,"3,652 mg/kg bw",adverse effect observed, Aluminium metaphosphate,13776-88-0," Data on repeated dose toxicity are available for the target substances aluminium dihydrogen triphosphate and sodium aluminium phosphate covering both short- and Long-term exposures. In an OECD 422 study administration of the test substance resulted in severe atrophy in 1/10 males exposed to 1000 mg aluminium dihydrogen triphosphate/kg bw/day for over 46 days. Further, altered calcium and total protein levels were determined in females exposed to 1000 mg/kg bw/day. Based on these results, a conservative NOAEL of 300 mg/kg bw/day was derived in the conducted Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422). Exposure to sodium aluminium phosphate for over 90 days induced renal concretions in 2/4 male and 1/4 female beagle dogs, resulting in a NOAEL of 322.88 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69923661-a51f-4b1b-b4c5-ddfd88b152d9/documents/IUC5-7ab83f4f-cbd8-47a0-a050-c319c9e22b8f_4d19821b-84a0-4ef4-a662-19f02193a893.html,,,,,, Aluminium metaphosphate,13776-88-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69923661-a51f-4b1b-b4c5-ddfd88b152d9/documents/IUC5-7ab83f4f-cbd8-47a0-a050-c319c9e22b8f_4d19821b-84a0-4ef4-a662-19f02193a893.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,322.88 mg/kg bw/day,,dog Aluminium metaphosphate,13776-88-0,"Oral: LD50(rat, f) > 2000 mg/kg bw (OECD 423, GLP)Inhalation: LC50(rat, m/f) > 2.17 mg/L (max. achievable concentration, OECD 436, GLP)Dermal: no study available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69923661-a51f-4b1b-b4c5-ddfd88b152d9/documents/IUC5-ef39558d-2884-4b60-a0ca-1537f1379ef8_4d19821b-84a0-4ef4-a662-19f02193a893.html,,,,,, Aluminium metaphosphate,13776-88-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69923661-a51f-4b1b-b4c5-ddfd88b152d9/documents/IUC5-ef39558d-2884-4b60-a0ca-1537f1379ef8_4d19821b-84a0-4ef4-a662-19f02193a893.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Aluminium metaphosphate,13776-88-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69923661-a51f-4b1b-b4c5-ddfd88b152d9/documents/IUC5-ef39558d-2884-4b60-a0ca-1537f1379ef8_4d19821b-84a0-4ef4-a662-19f02193a893.html,,inhalation,discriminating conc.,"2,170 mg/m3",no adverse effect observed, Aluminium nitrate,13473-90-0,Studies of repeated dose toxiicity are available for the oral route of exposure. A modern guideline-compliant study performed with a read-across substance provides comparanle results to older published drinking water stuides performed with aluminium nitrate ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a5ebb29b-4eca-40ed-ade1-e743adb42ce8/documents/IUC5-e52b29a6-6893-4fdd-9a3c-51adf361bf9a_fde47fa0-9116-4660-b943-24f8b3562592.html,,,,,, Aluminium nitrate,13473-90-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a5ebb29b-4eca-40ed-ade1-e743adb42ce8/documents/IUC5-e52b29a6-6893-4fdd-9a3c-51adf361bf9a_fde47fa0-9116-4660-b943-24f8b3562592.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,409 mg/kg bw/day,,rat Aluminium nitrate,13473-90-0,Published guideline-comparable studies of the acute oral toxicity of with aluminium nitrate are available in the rat and mouse. No data are presented for acute inhalation toxicity; a waiver is provided for thie endpoint. An acute dermal toxicity study performed with the read-across substance aluminium sulphate is available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5ebb29b-4eca-40ed-ade1-e743adb42ce8/documents/IUC5-f2130659-8c9b-4dc9-aaaf-d44e89a73ed5_fde47fa0-9116-4660-b943-24f8b3562592.html,,,,,, Aluminium nitrate,13473-90-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5ebb29b-4eca-40ed-ade1-e743adb42ce8/documents/IUC5-f2130659-8c9b-4dc9-aaaf-d44e89a73ed5_fde47fa0-9116-4660-b943-24f8b3562592.html,,oral,LD50,"2,060 mg/kg bw",no adverse effect observed, Aluminium nitrate,13473-90-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5ebb29b-4eca-40ed-ade1-e743adb42ce8/documents/IUC5-f2130659-8c9b-4dc9-aaaf-d44e89a73ed5_fde47fa0-9116-4660-b943-24f8b3562592.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Aluminium nitride,24304-00-5," In a 28-day repeated dose inhalation toxicity study (according to OECD 412) adverse local effects were seen after inhalation of the target substance at 10 mg/m³ and 70 mg/m³. No adverse systemic effects were reported up to the maximum attained concentration of 70 mg/m³. No repeated dose oral toxicity data is available for aluminium nitride. However, suitable data is available from the read across partner aluminium potassium sulfate. A subchronic repeated dose oral toxicity study in rats (similar to EU method B.26) and a chronic oral toxicity study in mice (similar to EU method B.33) were conducted using aluminium potassium sulfate. No adverse effects have been reported up to 100.000 ppm in the diet (15.000 mg/kg bw/day). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/303194f7-2c60-45c6-ab7c-ff191e330715/documents/IUC5-0bcea11a-c7e2-44ef-b200-df8d62aef513_55d151d9-8974-4187-b558-09026031b24b.html,,,,,, Aluminium nitride,24304-00-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/303194f7-2c60-45c6-ab7c-ff191e330715/documents/IUC5-0bcea11a-c7e2-44ef-b200-df8d62aef513_55d151d9-8974-4187-b558-09026031b24b.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,70 mg/m3,,rat Aluminium nitride,24304-00-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/303194f7-2c60-45c6-ab7c-ff191e330715/documents/IUC5-0bcea11a-c7e2-44ef-b200-df8d62aef513_55d151d9-8974-4187-b558-09026031b24b.html,Chronic toxicity – systemic effects,oral,NOAEL,"15,000 mg/kg bw/day",,mouse Aluminium nitride,24304-00-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/303194f7-2c60-45c6-ab7c-ff191e330715/documents/IUC5-0bcea11a-c7e2-44ef-b200-df8d62aef513_55d151d9-8974-4187-b558-09026031b24b.html,Repeated dose toxicity – local effects,inhalation,NOAEC,2 mg/m3,adverse effect observed,rat Aluminium nitride,24304-00-5,"Relevant data for the target substance were referenced in the study by Landry (1994, see section 7.5.2). In an acute oral toxicity study rats were orally exposed to the target substance at a concentration of 2000 mg/kg bw. No mortality occurred. Therefore, the oral LD50 is considered to be greater than 2000 mg/kg bw. In an acute inhalation toxicity study rats were exposed to 317 mg/m³ for four hours to aluminium nitride. No remarkable adverse effects were noted. Thus, based on the results presented the LC50 can be considered to be greater than 317 mg/m³. These results were supported in a weight-of-evidence approach by the following data from read-across substances. In an acute oral toxicity study young adult Wistar rats were orally exposed to the highly soluble aluminium chloride. The oral LD50 was considered to be 3470 mg/kg bw and 3450 mg/kg bw, in females and males, respectively. In an acute inhalation study rats were exposed to a concentration up to 1000 mg/m³ of aluminium flakes for four hours. No mortality was observed during a 6 months post-exposure period. Thus, the LC50 can be considered to be greater than 1000 mg/m³. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/303194f7-2c60-45c6-ab7c-ff191e330715/documents/IUC5-1a123d16-8a93-4041-bbea-c13fa5d6abdb_55d151d9-8974-4187-b558-09026031b24b.html,,,,,, Aluminium orthophosphate,7784-30-7," Data on repeated dose toxicity are available for the source substances aluminium dihydrogen triphosphate and sodium aluminium phosphate covering both short- and Long-term exposures. Administration of the source substance aluminium dihydrogen triphosphate resulted in severe atrophy in 1/10 males exposed to 1000 mg Aluminium dihydrogen triphosphate/kg bw/day for over 46 days. Further, altered calcium and total protein levels were determined in females exposed to 1000 mg/kg bw/day. Based on these results, a conservative NOAEL of 300 mg/kg bw/day was derived in the conducted Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422). Exposure to sodium aluminium phosphate for over 90 days induced renal concretions in 2/4 male and 1/4 female beagle dogs, resulting in a NOAEL of 322.88 mg/kg bw/day. This study is considered to be the key study for this endpoint. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1eb17027-7e46-4dc1-9910-062e91f7b93d/documents/fc4d7e6f-dfed-46a5-bc95-bfdc224c8479_f5f2eb3d-c5be-4567-8d04-fce5eac48516.html,,,,,, Aluminium orthophosphate,7784-30-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1eb17027-7e46-4dc1-9910-062e91f7b93d/documents/fc4d7e6f-dfed-46a5-bc95-bfdc224c8479_f5f2eb3d-c5be-4567-8d04-fce5eac48516.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,322.88 mg/kg bw/day,,dog Aluminium orthophosphate,7784-30-7,"Key studies are available for acute oral and acute inhalation toxicity. These studies are performed under the conditions of GLP and to an appropriate OECD guideline. As such, these studies are considered to be adequate and reliable for use a key study for the purpose of REACH Registration and classification and labelling in accordance with EU CLP. It is not considered necessary to provide acute dermal toxicity data on the basis of the physiochemical and toxicological properties of aluminium orthophosphate. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1eb17027-7e46-4dc1-9910-062e91f7b93d/documents/IUC5-ceb25ec8-72d9-407a-bdac-dfcf5c07a41f_f5f2eb3d-c5be-4567-8d04-fce5eac48516.html,,,,,, Aluminium orthophosphate,7784-30-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1eb17027-7e46-4dc1-9910-062e91f7b93d/documents/IUC5-ceb25ec8-72d9-407a-bdac-dfcf5c07a41f_f5f2eb3d-c5be-4567-8d04-fce5eac48516.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Aluminium orthophosphate,7784-30-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1eb17027-7e46-4dc1-9910-062e91f7b93d/documents/IUC5-ceb25ec8-72d9-407a-bdac-dfcf5c07a41f_f5f2eb3d-c5be-4567-8d04-fce5eac48516.html,,inhalation,LC50,"5,100 mg/m3",no adverse effect observed, Aluminium sodium tetrahydroxide,12251-53-5,"Based on read-acrossOral: NOAEL (chronic, rat) 322.5 mg/kg bw/day of aluminium citrate (equivalent to 30 mg Al/kg bw/day) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fae4d35-5566-4b44-86cc-61c2b74f4379/documents/f5b0bf18-a6a5-4629-9490-d93dd8af1c79_0cc12b60-860b-42fa-9842-480760b3506b.html,,,,,, Aluminium sodium tetrahydroxide,12251-53-5,"Sodium aluminate is corrosive to the skin and mucous membranes. Acute toxicity data is based on information from aluminium and aluminium compounds as structural analogues for read-across.Oral: LD50 > 2000 mg/kg bw (aluminium oxide, nanosized and bulk material)Inhalation: LC50 > 1000 mg Al/m³ air (aluminium flakes)Inhalation: LC50 > 5090 mg Al/m³ air (75% aluminium oxide, 25% aluminium hydroxide) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fae4d35-5566-4b44-86cc-61c2b74f4379/documents/6a903a87-5258-4a29-b739-457dda2dd0f7_0cc12b60-860b-42fa-9842-480760b3506b.html,,,,,, Aluminium tributanolate,3085-30-1," Upon contact with water or moisture (e.g. within mucous membranes) aluminium tributanolate hydrolyses immediately to butan-1ol and aluminium 3+ cations (as hydroxide and oxyhydroxide). Hence, toxicity is determined by the toxicity of these two species Four groups of male and female CD rats (30/sex/group) were administered daily by gavage 0, 30, 125 or 500 mg butan-1-ol /kgbw/d for either 6 or 13 weeks.  No dose-related differences were observed between treatment or control rats in body or organ weight changes, food consumption or mortality, gross pathology, and histopathological and ophthalmic evaluations.  Ataxia and hypoactivity (lasting less than 1 h) were observed 2 to 3 minutes after dosing in both sexes of the high-dose group (500/mg/kgbw/d) during the final 6 weeks of dosing.  nBA was not expected to persist or accumulate over time.  No treatment-related signs were observed in the 30 or 125 mg/kgbw/d treatment groups, the latter value being the no-observed adverse effect level (EPA 1986). Male Sprague-Dawley rats were exposed to aluminium hydroxide with diet at 302 mg Al/kg body weight for 28 days. During the entire experimental period, no mortality was reported and no treatment-related clinical signs were observed. There were no significant differences in body weight, food and water consumption and haematological parameters compared to controls that received basal diet. There were no other significant group differences in organ weights and microscopic changes. Aluminium concentrations in femur samples were <1 ppm (quantifiable in all 5 samples from animals treated with Al (OH)3 and in 2 samples from the control animals).The results of this study provide no evidence for significant deposition of Al in the bone and for toxicity of Al hydroxide during 28-day dietary administration at daily doses up to ≈300 mg Al/kg body weight. (Hicks 1987) Sodium aluminium phosphate was administered to beagle dogs with diet at concentrations 0% (control), 0.3%, 1.0% and 3.0% for 6 months. There were no significant group differences in body weight throughout the experiment. Reductions in mean body weight occurred in all groups during week 27, which the authors attributed to “pre-termination tests and increased handling by technicians.” No treatment-related clinical signs and no ocular changes in any of the animals were observed. In most weeks, treated male and female dogs consumed less food than control dogs. In male animals, none of the differences in mean food consumption values were statistically significant. In females, significant reductions occurred “sporadically”. The authors did not consider these differences in food consumption as “toxicologically significant”, a conclusion that was supported by the absence of corresponding reduction in body weights. The treatment did not have any effect on haematological and blood biochemistry parameters, urinalysis results and results of analysis for occult blood in faeces. There were no significant differences in mean organ weights between the treated groups and the control group. Gross pathology and histopathology findings were in the “normal range of variations for dogs of this strain and age”; no treatment-related lesions were observed. The results of this study provide no evidence for toxicity of acidic form of sodium aluminium phosphate during 6-month administration at concentrations up to 3% in the diet (30 mg/kg bw as Al) (Katz 1984). In a poorly documented study Aluminium (as Aluminium citrate) in drinking water was shown to affect erythropoiesis in rats with normal renal function (Vittori 1999). Rats were exposed to vapours of n-butanol at concentrations of 50 and 100 ppm 6 h/day, 5 days/week for 3 months (154 and 308 mg/m3). No significant changes in body weight gain, in absolute and relative organ weights and clinical biochemistry parameters were observed. N-butanol caused significant disturbances of motor coordination disturbances at 100 ppm. Significant increase in sensitivity to pain in animals exposed to n-butyl alcohol was observed. N-Butyl alcohol provoked the increase of lipid peroxidation in hepatic microsomes without any induction of cytochrome P450 monooxygenases (Korsal 1994). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e622708-0a17-4992-9d93-f3d085f51626/documents/253bf0d5-c86b-4ee2-a403-d0e5d43c19cd_61d1d909-b3b1-4eb3-bbc4-2d1dd7d6eb44.html,,,,,, Aluminium tributanolate,3085-30-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e622708-0a17-4992-9d93-f3d085f51626/documents/253bf0d5-c86b-4ee2-a403-d0e5d43c19cd_61d1d909-b3b1-4eb3-bbc4-2d1dd7d6eb44.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Aluminium tributanolate,3085-30-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e622708-0a17-4992-9d93-f3d085f51626/documents/253bf0d5-c86b-4ee2-a403-d0e5d43c19cd_61d1d909-b3b1-4eb3-bbc4-2d1dd7d6eb44.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,154 mg/m3,,rat Aluminium tributanolate,3085-30-1," Upon contact with water or moisture (e.g. within mucous membranes) aluminium tributanolate hydrolyses immediately to butan-1-ol and aluminium 3+ cations (as hydroxide and oxyhydroxide). Hence, toxicity is determined by the toxicity of these two species. The acute oral toxicity of butan-1-ol in rat as expressed as LD50 is between 2510 and 4360 mg/kg bw (Jenner 1964, Smyth 1951). For aluminium nitrate and aluminium tri-isopropanolate oral LD50 values of 4280 mg/kg and 11300 mg/kg bw are reported (Smyth 1969). For acute inhalation toxicity a LC50 of > 24.3 mg/L for butan-1-ol and a LC50 of 888 mg/m3 for aluminium flakes were derived (Korsak 1994, Reynolds 1986). The dermal LD50 for butan-1-ol in rabbits is between 4200 and 5300 mg/kg bw (Patty 1982). Butan-1-ol is not toxic via the dermal route, but is classified as harmful after swallowing (according to Annex VI of Regulation (EC) No 1272/2008). In several inhalation studies (not reported here) butan-1-ol showed local irritant effects on the respiratory system and transient effects on the CNS (drowsiness and dizziness) and is therefore classified as STOT SE 3, H335/H336 (according to Annex VI of Regulation EC 1272/2008). Aluminium species (hydroxide or oxide) that may be formed during hydrolysis are not classified for acute toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e622708-0a17-4992-9d93-f3d085f51626/documents/b789a52c-3802-44f6-b029-3913b42b41e3_61d1d909-b3b1-4eb3-bbc4-2d1dd7d6eb44.html,,,,,, Aluminium tributanolate,3085-30-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e622708-0a17-4992-9d93-f3d085f51626/documents/b789a52c-3802-44f6-b029-3913b42b41e3_61d1d909-b3b1-4eb3-bbc4-2d1dd7d6eb44.html,,oral,LD50,"2,510 mg/kg bw",no adverse effect observed, Aluminium tributanolate,3085-30-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e622708-0a17-4992-9d93-f3d085f51626/documents/b789a52c-3802-44f6-b029-3913b42b41e3_61d1d909-b3b1-4eb3-bbc4-2d1dd7d6eb44.html,,dermal,LD50,"4,200 mg/kg bw",no adverse effect observed, Aluminium tributanolate,3085-30-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e622708-0a17-4992-9d93-f3d085f51626/documents/b789a52c-3802-44f6-b029-3913b42b41e3_61d1d909-b3b1-4eb3-bbc4-2d1dd7d6eb44.html,,inhalation,LC50,"24,300 mg/m3",adverse effect observed, "Phosphinic acid, P,P-diethyl-, aluminum salt (3:1)",225789-38-8,"Key Study: OECD 407 (rat), NOAEL: 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac643806-83f2-4223-afe8-5537a8d3fa36/documents/IUC5-a5df2561-068b-4734-bc2b-71351b5a03f6_90daf93d-90cc-42fa-b8b7-eea3b255dd44.html,,,,,, "Phosphinic acid, P,P-diethyl-, aluminum salt (3:1)",225789-38-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac643806-83f2-4223-afe8-5537a8d3fa36/documents/IUC5-a5df2561-068b-4734-bc2b-71351b5a03f6_90daf93d-90cc-42fa-b8b7-eea3b255dd44.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Phosphinic acid, P,P-diethyl-, aluminum salt (3:1)",225789-38-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac643806-83f2-4223-afe8-5537a8d3fa36/documents/IUC5-f8691d3f-26d1-46e2-b4fe-5ed822261190_90daf93d-90cc-42fa-b8b7-eea3b255dd44.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Phosphinic acid, P,P-diethyl-, aluminum salt (3:1)",225789-38-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac643806-83f2-4223-afe8-5537a8d3fa36/documents/IUC5-f8691d3f-26d1-46e2-b4fe-5ed822261190_90daf93d-90cc-42fa-b8b7-eea3b255dd44.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Aluminium triethanolate,555-75-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6421512e-07e8-43ce-8f6c-8d40bae47fb2/documents/1ef86c4b-8161-48f7-99a8-fedee5f26184_f5506032-596e-4eba-ab2c-b3165b4ca8f5.html,Chronic toxicity – systemic effects,inhalation,NOAEC,55.2 mg/m3,,rat Aluminium triethanolate,555-75-9, A reliable acute oral toxicity study (OECD 420) is available on the substance. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6421512e-07e8-43ce-8f6c-8d40bae47fb2/documents/1526fcce-548a-4497-9ea5-388d1005b00e_f5506032-596e-4eba-ab2c-b3165b4ca8f5.html,,,,,, Aluminium tris(dihydrogen phosphate),13530-50-2," Data on repeated dose toxicity are available for the source substances aluminium dihydrogen triphosphate and sodium aluminium phosphate covering both short- and Long-term exposures. Administration of the source substance aluminium dihydrogen triphosphate resulted in severe atrophy in 1/10 males exposed to 1000 mg Aluminium dihydrogen triphosphate/kg bw/day for over 46 days. Further, altered calcium and total protein levels were determined in females exposed to 1000 mg/kg bw/day. Based on these results, a conservative NOAEL of 300 mg/kg bw/day was derived in the conducted Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422). Exposure to sodium aluminium phosphate for over 90 days induced renal concretions in 2/4 male and 1/4 female beagle dogs, resulting in a NOAEL of 322.88 mg/kg bw/day. This study is considered to be the key study for this endpoint. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8cb11519-7e18-4544-9bfd-d9b2c9e997da/documents/ee2f0382-2abd-4293-b2f2-596c8bf0e3d3_fb99106d-81be-4664-856e-c3147e3affc0.html,,,,,, Aluminium tris(dihydrogen phosphate),13530-50-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8cb11519-7e18-4544-9bfd-d9b2c9e997da/documents/ee2f0382-2abd-4293-b2f2-596c8bf0e3d3_fb99106d-81be-4664-856e-c3147e3affc0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,322.88 mg/kg bw/day,,dog Aluminium tris(dihydrogen phosphate),13530-50-2,"Acute oral toxicity: A GLP study conducted according to OECD Guideline 401 concludes that the LD50 is greater than 2000mg/kg bw, (with 1/5 deaths at 2000mg/kg). According to Regulation (EC) No 1272/2008 (EU CLP) the test material will not be classified. This conclusion is supported by supporting data. Acute dermal toxicity: Testing was waived on the basis that further in vivo testing is considered to be scientifically unjustified (see discussion below).Acute inhalation toxicity: A GLP study conducted according to OECD Guideline 403 is available to assess the acute inhalation toxicity of aluminium tris(dihydrogen phosphate). The acute inhalation median lethal concentration (LC50) was found to be greater than 5.1 mg/ L (with no animal deaths resulting from treatment). In accordance with Regulation EC (No.) 1272/2008 (EU CLP) aluminium tris(dihydrogen phosphate) will not be classified for acute inhalation toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8cb11519-7e18-4544-9bfd-d9b2c9e997da/documents/IUC5-e1f22ced-9cf5-41b1-90f1-7cd68b4433d5_fb99106d-81be-4664-856e-c3147e3affc0.html,,,,,, Aluminium tris(dihydrogen phosphate),13530-50-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8cb11519-7e18-4544-9bfd-d9b2c9e997da/documents/IUC5-e1f22ced-9cf5-41b1-90f1-7cd68b4433d5_fb99106d-81be-4664-856e-c3147e3affc0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Aluminium tris(dihydrogen phosphate),13530-50-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8cb11519-7e18-4544-9bfd-d9b2c9e997da/documents/IUC5-e1f22ced-9cf5-41b1-90f1-7cd68b4433d5_fb99106d-81be-4664-856e-c3147e3affc0.html,,inhalation,LC50,"5,100 mg/m3",no adverse effect observed, Aluminium vanadium tetraoxide,13530-56-8," No acute toxicity studies with aluminium vanadium tetraoxide are available, thus the acute toxicity will be addressed with existing data on the dissociation products. Based on conservative read-across to potassium vanadium trioxide (a more soluble vanadium oxide with a higher vanadium content), aluminum vanadium tetraoxide meets classification criteria for acute toxicity (oral) Category 4. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b05b4b80-6d78-4ac4-aded-eff986b6c0fb/documents/06cfe563-5f06-4fdc-9b55-ce5d3da212d0_c12b9381-f937-4fe1-9a2c-3f30125450b3.html,,,,,, Aluminium vanadium tetraoxide,13530-56-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b05b4b80-6d78-4ac4-aded-eff986b6c0fb/documents/06cfe563-5f06-4fdc-9b55-ce5d3da212d0_c12b9381-f937-4fe1-9a2c-3f30125450b3.html,,oral,LD50,314 mg/kg bw,adverse effect observed, "Aluminium, 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex",68583-95-9,"Repeated oral The No observed adverse-effect level (NOAEL) in this study was 5.19% (2829 mg/kg bw/day) for male rats, and 1.39% (901 mg/kg bw/day) for female rats.   Repeated Inhalation: The short term toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical[The estimated vapor pressure of the test chemical was 3.86*10-21 Pa]. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.   Repeated dermal: The acute dermal median lethal dose (LD50) of test chemical was considered to be >2000 mg/kg body weight. The test chemical did not cause any dermal reactions to humans and rats in the skin sensitization as well skin irritation studies respectively. Hence, it can be expected that the test chemical shall not exhibit 28 day repeated dose toxicity via dermal route. Hence, this endpoint was considered for waiver.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a5ea6a4b-f5b2-4c6a-b35b-69495f66a1fc/documents/a749a99a-8a21-4c1c-9fdd-5137dac7d038_12bbd8c7-f875-4926-ba78-107e66040e63.html,,,,,, "Aluminium, 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex",68583-95-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a5ea6a4b-f5b2-4c6a-b35b-69495f66a1fc/documents/a749a99a-8a21-4c1c-9fdd-5137dac7d038_12bbd8c7-f875-4926-ba78-107e66040e63.html,Chronic toxicity – systemic effects,oral,NOAEL,900 mg/kg bw/day,,rat "Aluminium, 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex",68583-95-9,"Acute Oral A study was designed and conducted to determine the acute oral toxicity profile of the test chemical in Sprague Dawley rats.12 female, nulliparous and non-pregnant Sprague Dawley rats were used for the study. It was concluded that the acute oral median lethal dose (LD50) of the test chemical when administered to Sprague Dawley rats was considered to be greater than 2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it can be inferred that the test chemical does not exhibit acute toxicity by the oral route and can be considered as “Not Classified”.   Acute Inhalation The study need not be performed because exposure to humans via inhalation route is not likely taking into account the low vapour pressure of the test chemical [The estimated vapor pressure of the test chemical was 3.86*10-21 Pa] and/or the possibility of exposure to aerosols, particles or droplets of inhalable size. Hence, this endpoint was considered for waiver.   Acute Dermal The study was designed and conducted to determine the acute dermal toxicity profile of the given test chemical in Sprague Dawley rats. The test chemical was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was considered to be >2000 mg/kg body weight. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it can be inferred that the test chemical does not exhibit acute toxicity by the dermal route and can be considered as “Not Classified”.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5ea6a4b-f5b2-4c6a-b35b-69495f66a1fc/documents/304a0946-e97e-4fc4-98f5-2d8dc163c78a_12bbd8c7-f875-4926-ba78-107e66040e63.html,,,,,, "Aluminium, 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex",68583-95-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5ea6a4b-f5b2-4c6a-b35b-69495f66a1fc/documents/304a0946-e97e-4fc4-98f5-2d8dc163c78a_12bbd8c7-f875-4926-ba78-107e66040e63.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aluminium, 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex",68583-95-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5ea6a4b-f5b2-4c6a-b35b-69495f66a1fc/documents/304a0946-e97e-4fc4-98f5-2d8dc163c78a_12bbd8c7-f875-4926-ba78-107e66040e63.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex",15790-07-5," Prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (15790-07-5) .The study assumed the use of male and female Sprague-Dawley rats in subacute study of 28days. No significant alterations were noted at the dose level of 585.3 mg/kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex is considered to be 585.3 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc45b2fc-050c-4690-ad95-c83d445f938f/documents/20568d5a-1de0-4d55-9b57-fbc2cab263ca_f996abf9-ed6b-4e89-a653-34c1de813167.html,,,,,, "Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex",15790-07-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc45b2fc-050c-4690-ad95-c83d445f938f/documents/20568d5a-1de0-4d55-9b57-fbc2cab263ca_f996abf9-ed6b-4e89-a653-34c1de813167.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,585.3 mg/kg bw/day,,rat "Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex",15790-07-5," Acute oral toxicity:  Acute oral toxicity dose (LD50) for Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. - 15790-07-5) was determined by Sustainability Support Services (Europe) AB as >2000 mg/kg body weight.It was concluded that LD50 value is greater than 2000 mg/kg bw.Thus, acute toxicity study of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex, when administered via oral route in wistar albino female rats falls into the “Category 5 (>2000-5000) and LD50 cutoff is 5000 mg/kg b.wt by Harmonized Classification (GHC). Acute Inhalation toxicity:  Acute Inhalation toxicity dose (LC50) of aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex was predicted based on OECD QSAR toolbox 1705.881mg/L air and 1456.383 mg/L and different studies available for the functionally similar read across substance Calcium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl) azo]-2-naphthoate (CAS no: 5281-04-9) >1510 mg/m3 and Disodium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate (CAS no: 5858-81-1) >1510 mg/m3. All these studies concluded that the LC50 value is greater than 5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex can be classified as category V of acute inhalation toxicity. Acute dermal toxicity: Acute dermal toxicity dose (LD50) for Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. - 15790-07-5) was determined by Sustainability Support Services (Europe) AB as >2000 mg/kg body weight.It was concluded that LD50 value is greater than 2000 mg/kg bw.Thus, acute toxicity study of Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex, when applied by dermal route in wistar albino rats falls into the “Category 5 (>2000) by Harmonized Classification (GHC). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc45b2fc-050c-4690-ad95-c83d445f938f/documents/IUC5-9b1e2082-0930-451e-9db2-8d1b871ddc79_f996abf9-ed6b-4e89-a653-34c1de813167.html,,,,,, "Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex",15790-07-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc45b2fc-050c-4690-ad95-c83d445f938f/documents/IUC5-9b1e2082-0930-451e-9db2-8d1b871ddc79_f996abf9-ed6b-4e89-a653-34c1de813167.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex",15790-07-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc45b2fc-050c-4690-ad95-c83d445f938f/documents/IUC5-9b1e2082-0930-451e-9db2-8d1b871ddc79_f996abf9-ed6b-4e89-a653-34c1de813167.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex",15790-07-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc45b2fc-050c-4690-ad95-c83d445f938f/documents/IUC5-9b1e2082-0930-451e-9db2-8d1b871ddc79_f996abf9-ed6b-4e89-a653-34c1de813167.html,,inhalation,LC50,"1,705.881 mg/m3",no adverse effect observed, "Aluminium, compound with nickel (1:1)",12003-78-0,"The 48 hour LD50 (oral) is calculated at greater than 31,600 mg/kg in the rat.The 48 hour LC50 (inhalation) is calculated at greater than 2 µg/m³ in the rat.The 48 hour LD50 (dermal) is calculated at greater than 2 mg/kg in the rabbit. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/030aa43d-70ea-40ff-82b1-4885282e534e/documents/IUC5-bed0b8df-10b0-43ab-86cd-4b4b717561b1_ffb03aba-6894-472e-8dbe-a58e9e42ed96.html,,,,,, "Aluminium, compound with nickel (1:1)",12003-78-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/030aa43d-70ea-40ff-82b1-4885282e534e/documents/IUC5-bed0b8df-10b0-43ab-86cd-4b4b717561b1_ffb03aba-6894-472e-8dbe-a58e9e42ed96.html,,oral,LD50,"31,600 mg/kg bw",no adverse effect observed, "Aluminium, compound with nickel (1:1)",12003-78-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/030aa43d-70ea-40ff-82b1-4885282e534e/documents/IUC5-bed0b8df-10b0-43ab-86cd-4b4b717561b1_ffb03aba-6894-472e-8dbe-a58e9e42ed96.html,,dermal,LD50,2 mg/kg bw,no adverse effect observed, "Aluminium, compound with nickel (1:1)",12003-78-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/030aa43d-70ea-40ff-82b1-4885282e534e/documents/IUC5-bed0b8df-10b0-43ab-86cd-4b4b717561b1_ffb03aba-6894-472e-8dbe-a58e9e42ed96.html,,inhalation,LC50,2.2 ,no adverse effect observed, "Aluminoxanes, iso-Bu Me, branched, cyclic and linear",146905-79-5," Testing is waived due to corrosivity, pyrophoricity and violent reaction with water ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31e42b4f-dc9f-4040-8764-fc6c9f92bf90/documents/e04bebc8-4f07-462f-89de-9e2898475770_31697b15-d411-4d1f-ba44-bdb54773447d.html,,,,,, Cesium fluoroaluminate,138577-01-2,"A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422 (2016); GLP) with cesium fluoroaluminate was conducted in rats. The no observed adverse effect level (NOAEL) for systemic toxicity in male and female parental animals is below 75 mg/kg bw/day based on haematology, clinical chemistry, organ weights and histopathology. A lowest observed adverse effect level (LOAEL) is derived at 75 mg/kg bw/day for males and females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91d5381b-0b79-47e5-8d0a-a08cfcd2da3a/documents/37c59488-3520-4cd8-bfcf-5d7a9de28e3e_ec36b643-d1c3-4171-8c1d-6a3a237f4e4f.html,,,,,, Cesium fluoroaluminate,138577-01-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91d5381b-0b79-47e5-8d0a-a08cfcd2da3a/documents/37c59488-3520-4cd8-bfcf-5d7a9de28e3e_ec36b643-d1c3-4171-8c1d-6a3a237f4e4f.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,75 mg/kg bw/day,,rat Cesium fluoroaluminate,138577-01-2, Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 423; GLP; female rats) Acute inhalation toxicity: LC50 > 5.06 mg/L air (analytical) (OECD 436; GLP) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91d5381b-0b79-47e5-8d0a-a08cfcd2da3a/documents/84c17375-a1ee-4c1e-bf25-70c0d0956b3d_ec36b643-d1c3-4171-8c1d-6a3a237f4e4f.html,,,,,, "Aluminum chloride, basic",1327-41-9, Combined repeated dose with reproduction/developmental toxicity screening test (OECD 422) performed on Aluminium chloride basic didn't show any systemic effects in male and female rats up to the highest dose of 1000 mg/kg bw/d (90 mg Al3+/kg bw/day). Local effects (stomach irritation) were observed in males at 200 mg/kg bw/d (18 mg Al3+/kg bw/d) while no stomach irritation was not observed in females up to the highest dose. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9c67840-0928-4a45-92e2-97f5a8c2df01/documents/f6b20c96-3fab-4374-a24f-a9725f849657_b67eeb22-b7de-4cb6-8d0b-5eba6a3de847.html,,,,,, "Aluminum chloride, basic",1327-41-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9c67840-0928-4a45-92e2-97f5a8c2df01/documents/f6b20c96-3fab-4374-a24f-a9725f849657_b67eeb22-b7de-4cb6-8d0b-5eba6a3de847.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Aluminum chloride, basic",1327-41-9," - Oral route: the LD50 is  > 2,000 mg/kg bw  based on a weight of evidence (OECD 423, GLP, Kr. 1 and OECD  401, GLP, Kr. 1) - Dermal route: the LD50 of Chlorhydrol ultrafine towards male and female Sprague-Dawley rats is > 2,000 mg/kg bw (OECD , GLP, Kr. 2). - Inhalation route: no data available on the registered substance. However, the inhalatory LC50 (rat, aerosol , 4h) value of 202028/A (CAS N°: 39290-78-3) in rats was considered to exceed 5000 mg/m3 under the conditions of this study. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9c67840-0928-4a45-92e2-97f5a8c2df01/documents/0c91879e-d3b8-4087-a437-4c0662b55856_b67eeb22-b7de-4cb6-8d0b-5eba6a3de847.html,,,,,, "Aluminum chloride, basic",1327-41-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9c67840-0928-4a45-92e2-97f5a8c2df01/documents/0c91879e-d3b8-4087-a437-4c0662b55856_b67eeb22-b7de-4cb6-8d0b-5eba6a3de847.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aluminum chloride, basic",1327-41-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9c67840-0928-4a45-92e2-97f5a8c2df01/documents/0c91879e-d3b8-4087-a437-4c0662b55856_b67eeb22-b7de-4cb6-8d0b-5eba6a3de847.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aluminum chloride, basic",1327-41-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9c67840-0928-4a45-92e2-97f5a8c2df01/documents/0c91879e-d3b8-4087-a437-4c0662b55856_b67eeb22-b7de-4cb6-8d0b-5eba6a3de847.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Aluminum chloride, basic, reaction products with silica",675106-31-7,Inhalation exposures are the most relevant route and exposure at the maximum achievable concentrations did not result in any significant toxicity. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dae5b319-2a24-4cfc-999a-129dd24dd799/documents/dd827e0e-94a7-44d0-a68d-23b37626d2ea_40e1f4de-ba10-4c2a-a126-f09f7204692e.html,,,,,, "Aluminum chloride, basic, reaction products with silica",675106-31-7,Acute toxicity testing waived ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dae5b319-2a24-4cfc-999a-129dd24dd799/documents/29d779a5-f4fa-4345-9e30-37968228461f_40e1f4de-ba10-4c2a-a126-f09f7204692e.html,,,,,, Aluminum cobalt oxide,12672-27-4,Read-across with cobalt compounds:LOAEC (rat): 0.114 mg Co2+/m³ LOAEC (mouse): 0.114 mg Co2+/m³Read-across with aluminium compounds:There was only limited evidence for systemic toxicity (NOAELS: 200 - 3225 mg/kg bw/day based on various aluminium compounds). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1dde7f7d-2f56-466b-a7fd-6ba413021de1/documents/IUC5-d3bac375-4cec-4f4f-b6d4-7b8b3dd128dc_969db1a3-fb97-4e84-ae77-92c136b12f2b.html,,,,,, Aluminum cobalt oxide,12672-27-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1dde7f7d-2f56-466b-a7fd-6ba413021de1/documents/IUC5-8290d4aa-a915-40e9-b351-0d50436eb17c_969db1a3-fb97-4e84-ae77-92c136b12f2b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, divanadium(5+) dialuminium(3+) magnesium(2+) nonaoxidandiide,170621-28-0, Oral: Repeated dose 90-Day oral toxicity study in rodents (OECD 408) rat: NOAEL (systemic) = 1000 mg/kg bw/day (m/f) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ed8212f-7aed-4530-ba35-207da4ebc4ec/documents/d413bf23-b02b-4401-8b51-7d80f5ca4853_508ccc7f-7708-4e74-98ec-2d1593559b36.html,,,,,, divanadium(5+) dialuminium(3+) magnesium(2+) nonaoxidandiide,170621-28-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ed8212f-7aed-4530-ba35-207da4ebc4ec/documents/d413bf23-b02b-4401-8b51-7d80f5ca4853_508ccc7f-7708-4e74-98ec-2d1593559b36.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat divanadium(5+) dialuminium(3+) magnesium(2+) nonaoxidandiide,170621-28-0,"Oral (OECD 423, limit test), rat (f): LD50 experimental > 2000 mg/kg bw; LD50 cut-off > 5000 mg/kg bw Inhalation (OECD 403, limit test), rat (m/f): LC50 > 5.0 mg/L (nominal); LC50: 4.852 mg/L (analytical)Dermal (OECD 402, limit test), rat (m/f): LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ed8212f-7aed-4530-ba35-207da4ebc4ec/documents/f9555a3e-23b7-4c91-a8c2-8ca81ac929ed_508ccc7f-7708-4e74-98ec-2d1593559b36.html,,,,,, divanadium(5+) dialuminium(3+) magnesium(2+) nonaoxidandiide,170621-28-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ed8212f-7aed-4530-ba35-207da4ebc4ec/documents/f9555a3e-23b7-4c91-a8c2-8ca81ac929ed_508ccc7f-7708-4e74-98ec-2d1593559b36.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, divanadium(5+) dialuminium(3+) magnesium(2+) nonaoxidandiide,170621-28-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ed8212f-7aed-4530-ba35-207da4ebc4ec/documents/f9555a3e-23b7-4c91-a8c2-8ca81ac929ed_508ccc7f-7708-4e74-98ec-2d1593559b36.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, divanadium(5+) dialuminium(3+) magnesium(2+) nonaoxidandiide,170621-28-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ed8212f-7aed-4530-ba35-207da4ebc4ec/documents/f9555a3e-23b7-4c91-a8c2-8ca81ac929ed_508ccc7f-7708-4e74-98ec-2d1593559b36.html,,inhalation,LC50,"4,852 mg/m3",no adverse effect observed, Aluminum sodium oxide,11138-49-1,"Based on read-acrossOral: NOAEL (chronic, rat) 322.5 mg/kg bw/day of aluminium citrate (equivalent to 30 mg Al/kg bw/day) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47116416-653d-456e-9ee9-2aa290cf5523/documents/e41e994c-8f1f-4615-ba42-87583e0b4e0e_663ee2bd-be76-446c-b093-732706359f47.html,,,,,, Aluminum sodium oxide,11138-49-1,"Sodium aluminate is corrosive to the skin and mucous membranes. Acute toxicity data is based on information from aluminium and aluminium compounds as structural analogues for read-across.Oral: LD50 > 2000 mg/kg bw (aluminium oxide, nanosized and bulk material)Inhalation: LC50 > 1000 mg Al/m³ air (aluminium flakes)Inhalation: LC50 > 5090 mg Al/m³ air (75% aluminium oxide, 25% aluminium hydroxide) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47116416-653d-456e-9ee9-2aa290cf5523/documents/06e78fd0-5fdc-407a-99e6-21ba231d9f5b_663ee2bd-be76-446c-b093-732706359f47.html,,,,,, Aluminum zirconium chloride hydroxide,57158-29-9,"Overall, the following NOAELs are taken forward (see discussion): - 91d dermal systemic NOAEL = 875 mg/kg bw/day based on registered substance aluminium zirconium chloride hydroxide (derived from a NOAEL for an aluminium zirconium glycinate compound (""ZAG"")). - 28d oral systemic NOAEL = 464 mg based on registered substance aluminium zirconium chloride hydroxide (derived from a NOAEL for basic aluminium chloride). This NOAEL is lower than when calculated using an equivalent results for the zirconiummoiety). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8481906e-0d83-4dfd-bfae-0839ee8bad70/documents/ed46f917-1a80-4663-8e04-cdfde999bc30_1de5734d-465c-4a3c-a3bb-f6983912f02a.html,,,,,, Aluminum zirconium chloride hydroxide,57158-29-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8481906e-0d83-4dfd-bfae-0839ee8bad70/documents/ed46f917-1a80-4663-8e04-cdfde999bc30_1de5734d-465c-4a3c-a3bb-f6983912f02a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,464 mg/kg bw/day,,rat Aluminum zirconium chloride hydroxide,57158-29-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8481906e-0d83-4dfd-bfae-0839ee8bad70/documents/ed46f917-1a80-4663-8e04-cdfde999bc30_1de5734d-465c-4a3c-a3bb-f6983912f02a.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,875 mg/kg bw/day,,rabbit Aluminum zirconium chloride hydroxide,57158-29-9,"Acute oral toxicity: three reliable, guideline conform studies (OECD 401) are available with different commercial forms of the substance aluminium zirconium chloride hydroxide (powder and solution form). All studies indicate a low acute oral toxicity, with the LD50 larger than the limit dose, i.e. > 2000 mg/kg.Acute inhalation toxicity: Based on uses and particle size consideration, the potential for inhalation exposure is low for aluminium zirconium chloride hydroxide (dermal and oral exposure more relevant).Acute dermal toxicity: two reliable, guideline conform studies (OECD 402) are available with different commercial forms of the substance aluminium zirconium chloride hydroxide (solution form). Both studies indicate a low acute dermal toxicity, with the LD50 larger than the limit dose, i.e. > 2000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8481906e-0d83-4dfd-bfae-0839ee8bad70/documents/a05bf25d-7728-4d4d-ab99-81871409bccb_1de5734d-465c-4a3c-a3bb-f6983912f02a.html,,,,,, sra-[(2E)-2-butenedioato(2-)hydroxy aluminium],1370461-06-5,"OECD 423 (BASF SE, 2015): Acute toxicity oral: no mortalities, LD50 > 2000 mg/kg bw ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f8a4345-e0af-43cb-91a8-c492cc0a3001/documents/IUC5-4f533a55-bc91-48ad-bc9d-9943282adb8b_229f4655-fac0-4efb-a21f-5cb666fbc286.html,,,,,, sra-[(2E)-2-butenedioato(2-)hydroxy aluminium],1370461-06-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f8a4345-e0af-43cb-91a8-c492cc0a3001/documents/IUC5-4f533a55-bc91-48ad-bc9d-9943282adb8b_229f4655-fac0-4efb-a21f-5cb666fbc286.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aluminum, 2-(2-quinolinyl)-1H-indene-1,3(2H)-dione sulfo derivs. complexes",100208-62-6, NOAEL (repeated oral toxicity rat chronic study) = 250 mg/kg bw/ day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6a6754a-94a0-49c9-8b97-a655a3eae740/documents/fef4e73c-cab4-4552-a6d6-6d83495a3898_9ece8954-939f-4583-b728-7b17ac690ea6.html,,,,,, "Aluminum, 2-(2-quinolinyl)-1H-indene-1,3(2H)-dione sulfo derivs. complexes",100208-62-6, LD50 rat oral > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6a6754a-94a0-49c9-8b97-a655a3eae740/documents/4cca3ee8-a2f2-460c-9f34-af237340cc82_9ece8954-939f-4583-b728-7b17ac690ea6.html,,,,,, "Aluminum, dross",69011-71-8,"From the acute inhalation toxicity test (endpoint 7.2.2), it was not possible to grind the test substance to a fine powder able to generate an appropriate inhalation atmosphere for testing as shown in the feasibility report. According to REACH Regulation, Annex XI, a study needs not be performed if there are technical obstacles. According to ECHA guidance document R7.A for inhalation route, no testing is required if it is not technically possible to generate a testing atmosphere. Read-across to individual constituents and degradation products is ventured for C&L purposes.Regarding studies on the individual constituents of aluminium dross i) the read-across study on aluminium metal (endpoint Aluminium_metal_Gross_et_al_1973) was actually a subchronic toxicity study (180 days) ii) the read-across study on aluminium oxide used (endpoint Aluminium_Oxide_Gross_et_al_1973) was actually a subchronic toxicity study (180 days) iii) the read-across study on ammonia (endpoint Ammonia_Coon_et_al_1970) was actually a subchronic toxicity study (90 days). Both of the studies i) and ii) revealed a NOAEL resulting in a DNEL comparable to occupational limits for total dusts (TWA 10 mg/m3). Exposure of general population to respirable/inhalable fractions of Aluminium dross is not expected. Therefore, safe use of Aluminium dross is ensured based on the results of the subchronic studies of Aluminium dross constituents, hence no longer term studies are proposed.A LOAEC of 50mg Aluminium metal dust/m3 was selected for the derivation of DNEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48edc6c4-7de0-40a7-82ce-23bedbff5c9e/documents/IUC5-575e963f-de6c-40db-a549-d50345eebf31_36001d84-4358-4fec-a9e3-4ecf7d35c16e.html,,,,,, "Aluminum, dross",69011-71-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48edc6c4-7de0-40a7-82ce-23bedbff5c9e/documents/IUC5-575e963f-de6c-40db-a549-d50345eebf31_36001d84-4358-4fec-a9e3-4ecf7d35c16e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,187.5 mg/m3,,rat "Aluminum, dross",69011-71-8,Aluminium dross is not expected to be absorbed via the gastrointestinal tract after oral administration. This is inferred by the study of acute toxicity via oral route (conducted as limit test) where no sign of systemic toxicity was found. Acute toxicity via inhalation route was not feasible since it was not possible to generate an appropriate inhalation atmosphere. Read-across to aluminium metal revealed an acute inhalation LC50 of more than 1000 mg/m3. No other constituents of Al dross present a significant toxicological profile on acute inhalation. Studies on dermal exposure were disregarded since dermal contact in the production and/or use is unlikely and inhalation is likely ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48edc6c4-7de0-40a7-82ce-23bedbff5c9e/documents/IUC5-d0ee1f65-caec-45a3-adf9-9a3983802c52_36001d84-4358-4fec-a9e3-4ecf7d35c16e.html,,,,,, "Aluminum, dross",69011-71-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48edc6c4-7de0-40a7-82ce-23bedbff5c9e/documents/IUC5-d0ee1f65-caec-45a3-adf9-9a3983802c52_36001d84-4358-4fec-a9e3-4ecf7d35c16e.html,,oral,LD50,"2,000 mg/kg bw",, "Aluminum, dross",69011-71-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48edc6c4-7de0-40a7-82ce-23bedbff5c9e/documents/IUC5-d0ee1f65-caec-45a3-adf9-9a3983802c52_36001d84-4358-4fec-a9e3-4ecf7d35c16e.html,,inhalation,LC50,"11,180,000 mg/m3",, Ametryn,834-12-8,"Wistar rats were administered Ametryn Technical (Ametryn) in the diet at concentrations of 0 (control), 75 ppm, 280 ppm, or 1000 ppm daily for 2 years in a key, GLP, combined chronic toxicity and carcinogenicity study conducted according to OECD Test Guideline 453. Based on a review of the key study data, the No Observed Effect Level (NOEL) was determined to be 75 ppm which is equivalent to 3.8, 5.0 and 4.4 mg/kg body weight/day for males, females and combined sex, respectively. Key studies also were reported for 28-day and 90-day oral studies and a 21-day dermal study. A NOEL of 750 ppm (equivalent to 86.9, 101.7, and 94.3 mg/kg body weight/day of Ametryn for males, females, and combined, respectively) was established from a key 28-day dietary study conducted in rats. The NOEL from a 90-day key dietary study in rats was determined to be 100 ppm (equivalent to 7.4 and 7.6 mg/kg body weight in males and females, respectively). A 21-day key dermal study was conducted in New Zealand White rabbits. The maximum tolerated dose (MTD) was determined to be 1000 mg/kg body weight/day and the NOEL was established at 100 mg/kg body weight/day.Supportive studies included 28-day range-finding dietary studies in mice and dogs and subchronic 90-day studies in mice, rats (2 studies), and dogs. A supportive 1-year study was conducted with Ametryn in Beagle dogs. Two supportive 2-year chronic toxicity studies were conducted in mice and a single supportive 2-year chronic toxicity study was conducted in rats. No inhalation repeat-dose toxicity studies have been conducted. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34864af1-54a0-4291-96ce-e04518b3319c/documents/IUC5-1147a0e7-b07d-4d8a-b48b-30a15740734e_7e513b96-7438-4b8e-ba51-806bdfbf042c.html,,,,,, Ametryn,834-12-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34864af1-54a0-4291-96ce-e04518b3319c/documents/IUC5-1147a0e7-b07d-4d8a-b48b-30a15740734e_7e513b96-7438-4b8e-ba51-806bdfbf042c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,4.4 mg/kg bw/day,, Ametryn,834-12-8,"LD50 (Oral, rat): >300 but < 2000 mg/kg bwLD50 (Dermal, rat): >2000 mg/kg bwLC50 (Inhalation dust/mist, rat): > 2.22 mg/L ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34864af1-54a0-4291-96ce-e04518b3319c/documents/IUC5-b36717bc-472a-4cf3-b141-c951e82ec710_7e513b96-7438-4b8e-ba51-806bdfbf042c.html,,,,,, "Amidase, penicillin",9014-06-6,"LD50 (oral,rat) > 2000 mg/kg (RA from the source substance aldolase, OECD 423, GLP) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/181f6a7b-8e5c-47ef-bee5-94db46ee9ae3/documents/58becb13-fa1c-40fe-a8cb-b42d220e04ac_1858bfdd-7663-4c6e-a94b-e02c1e502682.html,,,,,, "Amides, C12-18(even-numbered) and C18(unsatd.), N,N-bis(hydroxyethyl)",90622-74-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5f33d55-7e01-455c-9ff1-7a9702bbd3a6/documents/77e48f4b-ba08-44eb-b8c1-b2839d9ff229_15c009d3-3fba-49a7-b59e-3cf2a36efd7d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,700 mg/kg bw/day,,rat "Amides, C12-18(even-numbered) and C18(unsatd.), N,N-bis(hydroxyethyl)",90622-74-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5f33d55-7e01-455c-9ff1-7a9702bbd3a6/documents/77e48f4b-ba08-44eb-b8c1-b2839d9ff229_15c009d3-3fba-49a7-b59e-3cf2a36efd7d.html,Chronic toxicity – systemic effects,dermal,NOAEL,50 mg/kg bw/day,,rat "Amides, C12-18(even-numbered) and C18(unsatd.), N,N-bis(hydroxyethyl)",90622-74-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Sufficient good quality data available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Sufficient data available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5f33d55-7e01-455c-9ff1-7a9702bbd3a6/documents/27898ef9-aeb7-45e5-982f-1a7769a26bb6_15c009d3-3fba-49a7-b59e-3cf2a36efd7d.html,,,,,, "Amides, C12-18(even-numbered) and C18(unsatd.), N,N-bis(hydroxyethyl)",90622-74-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5f33d55-7e01-455c-9ff1-7a9702bbd3a6/documents/27898ef9-aeb7-45e5-982f-1a7769a26bb6_15c009d3-3fba-49a7-b59e-3cf2a36efd7d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amides, C12-18(even-numbered) and C18(unsatd.), N,N-bis(hydroxyethyl)",90622-74-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5f33d55-7e01-455c-9ff1-7a9702bbd3a6/documents/27898ef9-aeb7-45e5-982f-1a7769a26bb6_15c009d3-3fba-49a7-b59e-3cf2a36efd7d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amides, C12-18(even-numbered) and C18(unsatd.), N-hydroxyethyl",90622-77-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Sufficient data is available to evaluate this endpoint. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dac11988-a7bd-424d-9267-3d6a40ca3e95/documents/4d3ca97b-2966-47d5-9336-6dd3c0eb5bba_e6575778-6121-4e51-a08b-e26fde4ae1ee.html,,,,,, "Amides, C12-18(even-numbered) and C18(unsatd.), N-hydroxyethyl",90622-77-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dac11988-a7bd-424d-9267-3d6a40ca3e95/documents/4d3ca97b-2966-47d5-9336-6dd3c0eb5bba_e6575778-6121-4e51-a08b-e26fde4ae1ee.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Amides, C12-18(even-numbered) and C18(unsatd.), N-hydroxyethyl",90622-77-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Sufficient data is available to evaluate this endpoint. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Sufficient information is available on read-across substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dac11988-a7bd-424d-9267-3d6a40ca3e95/documents/832b1854-75ee-44c2-858f-bb1782821bda_e6575778-6121-4e51-a08b-e26fde4ae1ee.html,,,,,, "Amides, C12-18(even-numbered) and C18(unsatd.), N-hydroxyethyl",90622-77-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dac11988-a7bd-424d-9267-3d6a40ca3e95/documents/832b1854-75ee-44c2-858f-bb1782821bda_e6575778-6121-4e51-a08b-e26fde4ae1ee.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, "Amides, C12-18(even-numbered) and C18(unsatd.), N-hydroxyethyl",90622-77-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dac11988-a7bd-424d-9267-3d6a40ca3e95/documents/832b1854-75ee-44c2-858f-bb1782821bda_e6575778-6121-4e51-a08b-e26fde4ae1ee.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)",68603-38-3,"A 90-d oral study conducted on a read across substance, C12 DEA from which a NOAEL of 50 mg/kg bw/d was established, showed effects at higher dose levels. However it is unclear whether the effects noted were related to the test substance itself or was a result of the nutritional deficiencies due to the un-palatability of the diet as evidenced by scattering of food (Sharrat et al., 1961). Further, a 28-d oral repeated dose toxicity study conducted with read across substance, C12-18 and C18-unsatd. DEA in rats revealed a NOAEL of >750 mg/kg bw/d based on absence of treatment-related effects at any of the tested dose levels. Based on this, it is scientifically justified to use the 28-d oral rat NOAEL of 750 mg/kg bw/d for this CSA as the POD. Regarding dermal route, 90-d and 2-yr studies on structurally similar substance, C8-18 and C18-unsatd. DEA have been conducted in both rats and mice. The following dose descriptors have been derived from these studies: - Sub-chronic dermal rat: NOAEL for systemic effects: 50 mg/kg bw/d based on renal tubule regeneration; LOAEL for local effects: 25 mg/kg bw/d based on non-neoplastic lesions on the skin; Sub-chronic dermal mouse: NOAEL for systemic effects: 200 mg/kg bw/d based on organ-weight changes; LOAEL for local effects: 50 mg/kg bw/d based non-neoplastic lesions on the skin. - Chronic dermal rat: NOAEL for systemic effects: 50 mg/kg bw/d based on pancreatic acinar atrophy and nephropathy; NOAEL for local effects: 50 mg/kg bw/d based on non-neoplastic lesions on the skin; Chronic dermal mouse LOAEL: 100 mg/kg bw/d based on thyroid gland follicular cell hyperplasia, hepatic and renal neoplasms and non-neoplastic lesions on the skin. As a conservative approach and giving preference to a longer duration study, the lower NOAEL of 50 mg/kg bw/d for the systemic effects and the NOAEL of 50 mg/kg bw/d for local effects will be used as the POD for deriving DNEL dermal value of long term systemic and local effects respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f7c684c-1960-4490-8687-191e92e24188/documents/IUC5-d31876ef-3941-4462-8493-ea2d0a870964_62a7e0fc-5269-4ae0-9800-1867d83d4385.html,,,,,, "Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)",68603-38-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f7c684c-1960-4490-8687-191e92e24188/documents/IUC5-d31876ef-3941-4462-8493-ea2d0a870964_62a7e0fc-5269-4ae0-9800-1867d83d4385.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)",68603-38-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f7c684c-1960-4490-8687-191e92e24188/documents/IUC5-d31876ef-3941-4462-8493-ea2d0a870964_62a7e0fc-5269-4ae0-9800-1867d83d4385.html,Chronic toxicity – systemic effects,dermal,NOAEL,50 mg/kg bw/day,,rat "Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)",68603-38-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f7c684c-1960-4490-8687-191e92e24188/documents/IUC5-d31876ef-3941-4462-8493-ea2d0a870964_62a7e0fc-5269-4ae0-9800-1867d83d4385.html,Repeated dose toxicity – local effects,dermal,NOAEL,281 ,adverse effect observed, "Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)",68603-38-3,"The available data suggests that amides, C16-18 (even numbered) and C18-unsatd., N,N-bis(hydroxyethyl) has a low potential for acute oral (LD50 >3,000 mg/kg bw) and dermal toxicity (LD50 >2,000 mg/kg bw, based on a study tested with read across substance, C8-18 and C18- unsatd., N,N-bis(hydroxyethyl). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f7c684c-1960-4490-8687-191e92e24188/documents/IUC5-29d95301-9ef7-4427-97cb-17fc2597f82d_62a7e0fc-5269-4ae0-9800-1867d83d4385.html,,,,,, "Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)",68603-38-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f7c684c-1960-4490-8687-191e92e24188/documents/IUC5-29d95301-9ef7-4427-97cb-17fc2597f82d_62a7e0fc-5269-4ae0-9800-1867d83d4385.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, "Amides, C16-18 and C18-unsatd., N,N-bis(hydroxyethyl)",68603-38-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f7c684c-1960-4490-8687-191e92e24188/documents/IUC5-29d95301-9ef7-4427-97cb-17fc2597f82d_62a7e0fc-5269-4ae0-9800-1867d83d4385.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amides, C16-C18 (even) , N,N'-ethylenebis",68390-94-3," Oral (subchronic, OECD 408): NOEL (rat, m/f) ≥ 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/403fcd9c-e5be-4243-9504-8a34ca30007f/documents/9159bf4a-0c6a-4b63-bd28-99b1b81447f4_c28621e5-a6e2-4899-8853-f17f91df15fa.html,,,,,, "Amides, C16-C18 (even) , N,N'-ethylenebis",68390-94-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/403fcd9c-e5be-4243-9504-8a34ca30007f/documents/9159bf4a-0c6a-4b63-bd28-99b1b81447f4_c28621e5-a6e2-4899-8853-f17f91df15fa.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Amides, C16-C18 (even) , N,N'-ethylenebis",68390-94-3," Oral (similar to OECD 401): LD50 > 5000 mg/kg bw (limit test, rat) Inhalation (OECD 403): LC50 > 6.3 mg/L (limit test, rat; 4 h exposure) Dermal (OECD 402): LD50 > 2000 mg/kg bw (limit test, rabbit) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/403fcd9c-e5be-4243-9504-8a34ca30007f/documents/ce57e5b1-dd22-456b-9b01-91b5e2b4155f_c28621e5-a6e2-4899-8853-f17f91df15fa.html,,,,,, "Amides, C16-C18 (even) , N,N'-ethylenebis",68390-94-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/403fcd9c-e5be-4243-9504-8a34ca30007f/documents/ce57e5b1-dd22-456b-9b01-91b5e2b4155f_c28621e5-a6e2-4899-8853-f17f91df15fa.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Amides, C16-C18 (even) , N,N'-ethylenebis",68390-94-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/403fcd9c-e5be-4243-9504-8a34ca30007f/documents/ce57e5b1-dd22-456b-9b01-91b5e2b4155f_c28621e5-a6e2-4899-8853-f17f91df15fa.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amides, C16-C18 (even) , N,N'-ethylenebis",68390-94-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/403fcd9c-e5be-4243-9504-8a34ca30007f/documents/ce57e5b1-dd22-456b-9b01-91b5e2b4155f_c28621e5-a6e2-4899-8853-f17f91df15fa.html,,inhalation,LC50,"6,300 mg/m3",no adverse effect observed, N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide,1228186-18-2," 28 day oral (OECD 407, GLP): LOAEL 50 mg/kg bw/day based on local irritation on stomach. 90 day oral (OECD 408, GLP): NOAEL 50 mg/kg bw/day based on increased cellularity of the paracortical areas of the mesenteric lymph node and microvesicular vacuolation of enterocytes of small intestines up to a slight degree seen at 150 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e81cc05-1a13-463d-8e9e-0ebdc5bf05a8/documents/IUC5-9f2bdced-98c6-4d80-86c5-0222a3ce6da0_44f410af-c821-4eea-9d89-758ee0984312.html,,,,,, N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide,1228186-18-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e81cc05-1a13-463d-8e9e-0ebdc5bf05a8/documents/IUC5-9f2bdced-98c6-4d80-86c5-0222a3ce6da0_44f410af-c821-4eea-9d89-758ee0984312.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide,1228186-18-2,"Acute Oral Toxicity testing according to the Acute Toxic Class Method resulted to an LD50 between 200 and 2000 mg/kg bw in rats, with a LD50 cut-off level of 1000 mg/kg bw.No acute dermal and inhalation toxicity studies were performed on the substance due to its corrosive properties. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e81cc05-1a13-463d-8e9e-0ebdc5bf05a8/documents/IUC5-78cd7ba3-bb7e-4444-957a-f36d69975132_44f410af-c821-4eea-9d89-758ee0984312.html,,,,,, N-[2-(piperazin-1-yl)ethyl]C18-insaturated-alkylamide,1228186-18-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e81cc05-1a13-463d-8e9e-0ebdc5bf05a8/documents/IUC5-78cd7ba3-bb7e-4444-957a-f36d69975132_44f410af-c821-4eea-9d89-758ee0984312.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, "amides, C18-unsatd., N-[3-(dimethylamine)propyl]",1379524-06-7,"In a 28-day repeated dose oral toxicity study conducted according to the OECD Guideline 407 and in compliance with GLP, the No Observed Adverse Effect Level (NOAEL) of N-[3-(dimethylamino)propyl]-C18 unsaturated-alkylamide (unsaturated C18) was considered to be 150 mg/kg bw/day in rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/477f531a-a780-4fae-b3a3-d2c59d40bb3b/documents/IUC5-6151402b-43ee-429a-8e11-3bef9ce68bd0_59bf897e-48c4-4a3e-961e-0915e718333d.html,,,,,, "amides, C18-unsatd., N-[3-(dimethylamine)propyl]",1379524-06-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/477f531a-a780-4fae-b3a3-d2c59d40bb3b/documents/IUC5-6151402b-43ee-429a-8e11-3bef9ce68bd0_59bf897e-48c4-4a3e-961e-0915e718333d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "amides, C18-unsatd., N-[3-(dimethylamine)propyl]",1379524-06-7,"One key acute oral toxicity study is available. The study was conducted according to OECD Guideline 401 and used rat Sprague-Dawley rats as the test species. The dose-level of 2000 mg/kg of N-[3-(dimethylamino)propyl]-C18 unsaturated-alkylamide (unsaturated C18) was estimated to be the oral median lethal dose, LD50 in rats. No studies are available for acute inhalation or dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/477f531a-a780-4fae-b3a3-d2c59d40bb3b/documents/IUC5-7a7db15c-13e9-4538-b423-df5ca210eef5_59bf897e-48c4-4a3e-961e-0915e718333d.html,,,,,, "amides, C18-unsatd., N-[3-(dimethylamine)propyl]",1379524-06-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/477f531a-a780-4fae-b3a3-d2c59d40bb3b/documents/IUC5-7a7db15c-13e9-4538-b423-df5ca210eef5_59bf897e-48c4-4a3e-961e-0915e718333d.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "Amides, C8-18(even-numbered) and C18(unsatd.), N-(2-hydroxypropyl)",1335203-30-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff038ecd-5eb8-40b1-b979-db08cc8529ac/documents/f0f29144-61ae-4717-a5da-fa9cb3abfd79_60dfd86b-64de-462f-992c-12d8a59eee36.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat "Amides, C8-18(even-numbered) and C18(unsatd.), N-(2-hydroxypropyl)",1335203-30-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Adequate Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Adequate ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff038ecd-5eb8-40b1-b979-db08cc8529ac/documents/bd2e7010-f074-4b65-8024-caf8869fa378_60dfd86b-64de-462f-992c-12d8a59eee36.html,,,,,, "Amides, C8-18(even-numbered) and C18(unsatd.), N-(2-hydroxypropyl)",1335203-30-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff038ecd-5eb8-40b1-b979-db08cc8529ac/documents/bd2e7010-f074-4b65-8024-caf8869fa378_60dfd86b-64de-462f-992c-12d8a59eee36.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amides, C8-18(even-numbered) and C18(unsatd.), N-(2-hydroxypropyl)",1335203-30-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff038ecd-5eb8-40b1-b979-db08cc8529ac/documents/bd2e7010-f074-4b65-8024-caf8869fa378_60dfd86b-64de-462f-992c-12d8a59eee36.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, reaction products with fatty acids C16-C18 and C18-unsatd, branched and linear, diethylenetriamine and citric acid",1393571-43-1," In a 90-day study in rats (oral gavage) with an anlogue no adverse effects were observed at the highest dose tested (Charles River 2016). In a study according to OECD 422 with a close analogue of the substance bronchopneumonia was observed in all dose groups (100, 300 and 1000 mg/kg bw). No NOAEL could be derived from this study. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/b530b87f-53df-4bb0-989c-435662abe202/documents/a6b926bd-55c9-4ef4-9bf8-e0090bf9f428_10b681f6-4278-4240-a581-f23cdd944d15.html,,,,,, "Fatty acids, tall-oil, reaction products with fatty acids C16-C18 and C18-unsatd, branched and linear, diethylenetriamine and citric acid",1393571-43-1,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/b530b87f-53df-4bb0-989c-435662abe202/documents/a6b926bd-55c9-4ef4-9bf8-e0090bf9f428_10b681f6-4278-4240-a581-f23cdd944d15.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, tall-oil, reaction products with fatty acids C16-C18 and C18-unsatd, branched and linear, diethylenetriamine and citric acid",1393571-43-1,The test substance was tested in an acute oral fixed dose test in rats. No mortality was observed at 2000 mg/kg bw. The LD50 is >2000 mg/kg bw. An analogue of the test substance was tested in an acute dermal toxicity study in rats. The LD50 is >2000 mg/kg bw. No inhalation study is available as exposure via the inhalation route is expected to be negligible. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b530b87f-53df-4bb0-989c-435662abe202/documents/IUC5-7c99af71-3247-48d8-81b1-60999af71f39_10b681f6-4278-4240-a581-f23cdd944d15.html,,,,,, "Fatty acids, tall-oil, reaction products with fatty acids C16-C18 and C18-unsatd, branched and linear, diethylenetriamine and citric acid",1393571-43-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b530b87f-53df-4bb0-989c-435662abe202/documents/IUC5-7c99af71-3247-48d8-81b1-60999af71f39_10b681f6-4278-4240-a581-f23cdd944d15.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, reaction products with fatty acids C16-C18 and C18-unsatd, branched and linear, diethylenetriamine and citric acid",1393571-43-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b530b87f-53df-4bb0-989c-435662abe202/documents/IUC5-7c99af71-3247-48d8-81b1-60999af71f39_10b681f6-4278-4240-a581-f23cdd944d15.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amides, fatty acids C18 unsat, reaction products with polyethylene amines",1226892-50-7,"An oral 28-day repeated dose toxicity study according to OECD 407 with Amides, fatty acids C18 unsat, reaction products with polyethylene amines resulted to a NOAEL of 100 mg/kg bw/day. All already available data from the group of Amidoamine/imidazolines (AAI) substances, including 90-day studies in rat and dogs on a similar substance, also indicate low repeated dose toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca1c77d4-b5b3-497d-97a8-54fb943985ce/documents/IUC5-fb7ad93e-5af1-4d5c-b62e-98fa96d420ee_55a6896b-d7a3-4ac5-bb43-413c9656e8a9.html,,,,,, "Amides, fatty acids C18 unsat, reaction products with polyethylene amines",1226892-50-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca1c77d4-b5b3-497d-97a8-54fb943985ce/documents/IUC5-fb7ad93e-5af1-4d5c-b62e-98fa96d420ee_55a6896b-d7a3-4ac5-bb43-413c9656e8a9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Amides, fatty acids C18 unsat, reaction products with polyethylene amines",1226892-50-7,Acute toxicity: Oral LD50 > 2000 mg/kg for rat. (Cut-off value 5000 mg/kg) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca1c77d4-b5b3-497d-97a8-54fb943985ce/documents/IUC5-fb94e29b-d8e9-4644-9018-4529c6d0f94c_55a6896b-d7a3-4ac5-bb43-413c9656e8a9.html,,,,,, "Amides, fatty acids C18 unsat, reaction products with polyethylene amines",1226892-50-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca1c77d4-b5b3-497d-97a8-54fb943985ce/documents/IUC5-fb94e29b-d8e9-4644-9018-4529c6d0f94c_55a6896b-d7a3-4ac5-bb43-413c9656e8a9.html,,oral,LD50,"5,000 mg/kg bw",, "Amides, Fatty acids C18 unsaturated, reaction products with tetraethylenepentamine",1225197-81-8,"A combined repeated dose/reproduction screening toxicity study according to OECD 422 with Fatty acid reaction products with tetraethylene-pentamine resulted to a NOAEL of 300 mg/kg bw/day being the highest tested dose level.All available data from t group of Amidoamine/imidazolines (AAI) substances, including 90-day studies in rat and dogs on a similar substance, also indicate low repeated dose toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4566e297-e39a-40ab-a955-e388f718ed3d/documents/IUC5-791c2e80-729f-4c37-9063-b57c2a8918b3_9211418f-245a-4b93-a64b-3994569096b8.html,,,,,, "Amides, Fatty acids C18 unsaturated, reaction products with tetraethylenepentamine",1225197-81-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4566e297-e39a-40ab-a955-e388f718ed3d/documents/IUC5-791c2e80-729f-4c37-9063-b57c2a8918b3_9211418f-245a-4b93-a64b-3994569096b8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Amides, Fatty acids C18 unsaturated, reaction products with tetraethylenepentamine",1225197-81-8,Acute toxicity: Oral LD50 > 2000 mg/kg for rat (LD50 cut-off: 2500 mg/kg bw) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4566e297-e39a-40ab-a955-e388f718ed3d/documents/IUC5-2d371a17-0479-4f8d-9bc3-7bf2f1e2cead_9211418f-245a-4b93-a64b-3994569096b8.html,,,,,, "Amides, Fatty acids C18 unsaturated, reaction products with tetraethylenepentamine",1225197-81-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4566e297-e39a-40ab-a955-e388f718ed3d/documents/IUC5-2d371a17-0479-4f8d-9bc3-7bf2f1e2cead_9211418f-245a-4b93-a64b-3994569096b8.html,,oral,LD50,"2,500 mg/kg bw",, "Fatty acids, tall-oil, reaction products with fatty acids C16-C18 and C18-unsatd, branched and linear, diethylenetriamine and maleic anhydride",1419212-77-3," In a 90-day study in rats (oral gavage) with an analogue no adverse effects were observed at the highest dose tested (Charles River 2016). In a study according to OECD 422 with a close analogue of the substance bronchopneumonia was observed in all dose groups (100, 300 and 1000 mg/kg bw). No NOAEL could be derived from this study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/117c7921-a37c-4dde-8b96-e9b9252b5e1d/documents/7b190864-1fb5-4219-8f82-2738cee4b9a2_2ab3c6cf-4427-489a-979b-960fd6506899.html,,,,,, "Fatty acids, tall-oil, reaction products with fatty acids C16-C18 and C18-unsatd, branched and linear, diethylenetriamine and maleic anhydride",1419212-77-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/117c7921-a37c-4dde-8b96-e9b9252b5e1d/documents/7b190864-1fb5-4219-8f82-2738cee4b9a2_2ab3c6cf-4427-489a-979b-960fd6506899.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, tall-oil, reaction products with fatty acids C16-C18 and C18-unsatd, branched and linear, diethylenetriamine and maleic anhydride",1419212-77-3,"The analogues of the test substance were tested in an acute oral test in rats (Stilmeadow 2001, Harlan 2012a). No mortality was observed at 2000 mg/kg bw. The LD50 is >2000 mg/kg bw. An analogue of the test substance was tested in an acute dermal toxicity study in rats (BSL 2010a). The LD50 is >2000 mg/kg bw. No inhalation study is available as exposure via the inhalation route is expected to be negligible. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/117c7921-a37c-4dde-8b96-e9b9252b5e1d/documents/daa89153-412e-40fd-94c9-43c0846fd337_2ab3c6cf-4427-489a-979b-960fd6506899.html,,,,,, "Fatty acids, tall-oil, reaction products with fatty acids C16-C18 and C18-unsatd, branched and linear, diethylenetriamine and maleic anhydride",1419212-77-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/117c7921-a37c-4dde-8b96-e9b9252b5e1d/documents/daa89153-412e-40fd-94c9-43c0846fd337_2ab3c6cf-4427-489a-979b-960fd6506899.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, reaction products with fatty acids C16-C18 and C18-unsatd, branched and linear, diethylenetriamine and maleic anhydride",1419212-77-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/117c7921-a37c-4dde-8b96-e9b9252b5e1d/documents/daa89153-412e-40fd-94c9-43c0846fd337_2ab3c6cf-4427-489a-979b-960fd6506899.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, reaction products with diethylenetriamine and maleic anhydride",1419212-76-2," In a 90-day study in rats (oral gavage) no adverse effects were observed at the highest dose tested (Charles River 2016). In a study according to OECD 422 with a close analogue of the substance bronchopneumonia was observed in all dose groups (100, 300 and 1000 mg/kg bw). No NOAEL could be derived from this study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f9d9c10-f852-4af2-a8f1-70c14fd82e35/documents/90d84599-e4bd-40a1-8aa3-2bdc30ae1f43_ec7bfc03-33e8-4feb-bc40-0e68654bf0c7.html,,,,,, "Fatty acids, tall-oil, reaction products with diethylenetriamine and maleic anhydride",1419212-76-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f9d9c10-f852-4af2-a8f1-70c14fd82e35/documents/90d84599-e4bd-40a1-8aa3-2bdc30ae1f43_ec7bfc03-33e8-4feb-bc40-0e68654bf0c7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, tall-oil, reaction products with diethylenetriamine and maleic anhydride",1419212-76-2,"The analogues of the test substance were tested in an acute oral test in rats (Stilmeadow 2001, Harlan 2012a). No mortality was observed at 2000 mg/kg bw. The LD50 is >2000 mg/kg bw. An analogue of the test substance was tested in an acute dermal toxicity study in rats (BSL 2010a). The LD50 is >2000 mg/kg bw. No inhalation study is available as exposure via the inhalation route is expected to be negligible. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f9d9c10-f852-4af2-a8f1-70c14fd82e35/documents/e35360c4-1b8b-47e2-a01d-8abcb84d03d5_ec7bfc03-33e8-4feb-bc40-0e68654bf0c7.html,,,,,, "Fatty acids, tall-oil, reaction products with diethylenetriamine and maleic anhydride",1419212-76-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f9d9c10-f852-4af2-a8f1-70c14fd82e35/documents/e35360c4-1b8b-47e2-a01d-8abcb84d03d5_ec7bfc03-33e8-4feb-bc40-0e68654bf0c7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amides, tall-oil fatty, N,N-di-Me",68308-74-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A 14-day range-finding study and the results of an OECD 422 screening study are available for the submission substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb5e6cbf-ab19-44a8-9c33-1d761e2e489c/documents/IUC5-03169e0b-e0fc-4a51-90d8-c5974636c80f_fe6a0ddb-d318-4027-8f6a-cfc8a0042239.html,,,,,, "Amides, tall-oil fatty, N,N-di-Me",68308-74-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb5e6cbf-ab19-44a8-9c33-1d761e2e489c/documents/IUC5-03169e0b-e0fc-4a51-90d8-c5974636c80f_fe6a0ddb-d318-4027-8f6a-cfc8a0042239.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Amides, tall-oil fatty, N,N-di-Me",68308-74-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): An older, guideline-comparable study is available for the submission substance and is supported by an older study in a non-standard species Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): An older study is available for the submission substance. The study is not fully comparable with current guidelines but is considered to be adequate for the purposes of hazard classification. The study is supported by an older non-standard data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb5e6cbf-ab19-44a8-9c33-1d761e2e489c/documents/IUC5-8370ba68-2e32-4bcc-869b-0274371bfb52_fe6a0ddb-d318-4027-8f6a-cfc8a0042239.html,,,,,, "Amides, tall-oil fatty, N,N-di-Me",68308-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb5e6cbf-ab19-44a8-9c33-1d761e2e489c/documents/IUC5-8370ba68-2e32-4bcc-869b-0274371bfb52_fe6a0ddb-d318-4027-8f6a-cfc8a0042239.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Amides, tall-oil fatty, N,N-di-Me",68308-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb5e6cbf-ab19-44a8-9c33-1d761e2e489c/documents/IUC5-8370ba68-2e32-4bcc-869b-0274371bfb52_fe6a0ddb-d318-4027-8f6a-cfc8a0042239.html,,dermal,,"7,128 mg/kg bw",no adverse effect observed, "Amides, vegetable-oil, N,N-bis(hydroxyethyl)",68155-26-0," Lauramide DEA CAS N. 120 -40 -1 SUBCHRONIC TOXICITY ORAL The subchronic oral toxicity of Lauramide DEA was studied in SPF rats. Fifteen male and 15 female rats per group were fed for 90 days diets containing 0 (controls), 0.1, 0.5, 1 .O, or 2.0% Lauramide DEA.Two male rats in the 1.0 % dietary group developed bronchopneumonia and were killed on Days 23 and 58, respectively. No other deaths occurred in any group during the test period. Growth was normal in the 0.1% group, slightly reduced in the 0.5% group, and moderately reduced in those animals consuming 1.0 or 2.0% Lauramide DEA. Growth retardation was associated with reduced food intake, at and above the 0.5% level. Hematological values were normal except for lower hemoglobin, hematocrit, and red blood cell count values in the rats fed 1 .O and 2.0% Lauramide DEA. Serum glutamic oxaloacetate transaminase activities were increased in animals fed diets of 0.5, 1 .O, and 2.0% Lauramide DEA. Bone marrow cytological values, renal function tests, and gross and microscopic findings of test animals were comparable to controls. The no-effect dose was 0.1% Lauramide DEA (equivalent to 50 mglkg per day) in the diet of rats for 90 days.‘46’   Groups of 20 male and 20 female Wistar rats were fed diets containing 0, 25, 80, or 250 mglkg per day Lauramide DEA for 13 weeks. All test animals were comparable to controls in general health, body weight and feed consumption, hematological values at 6 and 12 weeks, mortality (no deaths in any group), organ weights, and gross and microscopic findings. There were no differences between control and test group values of blood urea nitrogen, serum activities of glutamic oxalacetic transaminase and lactic dehydrogenase, or urinalysis (specific gravity, pH, albumin, glucose, and sediment) at either 6 or 12 weeks. A transient increase in blood glucose concentration at 6 weeks was observed when the male animals were consuming 250 mglkg per day Lauramide DEA. The no-effect dose for rats was 250 mg/kg per day.c4” COCAMIDE DEA CAS 68603 -42 -9 Sub Chronic Toxicity Dermal A study was conducted to evaluate the subchronic toxic effects of structurally similar 'amides, C8 -18 (even-numbered) and C18 -unsatd., N,N-bis(hydroxyethyl)' (i.e.,coconut oil acid diethanolamine condensate)when administered by dermal route in F344/N rats. The study was performed in compliance with Food and Drug Administration Good Laboratory Practice Regulations (21 CFR, Part 58). Groups of 10 male and 10 female rats were administered 0, 25, 50, 100, 200, or 400 mg/kg bw/d of the test substancein ethanol by dermal application for 14 weeks.   All rats survived until the end of the study. Final mean body weights and body weight gains of 200 and 400 mg/kg bw/d males and females were significantly less than those of the vehicle controls.Clinical findings included irritation of the skin at the site of application in 100, 200, and 400 mg/kg bw/d malesand females. Hematological changes include minimal microcytic anemia at the end of the treatment period.Decreases in cholesterol and triglyceride concentrations were observed in the higher group rats (i.e.,≥.100 mg/kg bw/d) Histopathological lesions of the skin at the site of application included epidermalhyperplasia, sebaceous gland hyperplasia, chronic active inflammation, parakeratosis, and ulcer. Theincidences and severities of these skin lesions generally increased with increasing dose in males andfemales. The incidences of epidermal hyperplasia in all dosed groups of males and in females administered 50 mg/kg bw/d or greater were significantly greater than those in the vehicle controls. The incidences of renal tubule regeneration in 100, 200, and 400 mg/kg bw/d females were significantly greater than the vehicle control incidence, and the severities in 200 and 400 mg/kg bw/d females were increased.   Under the test conditions, the No Observed Adverse Effect Level (NOAEL) for systemic effects of the test substance can be considered to be 50 mg/kg bw/d and the LOAEL for local effects at 25 mg/kg bw/d. COCAMIDE DEA CAS 68603 -42 -9 Chronic Toxicity Dermal A two-year dermal study was conducted in F344/N rats to evaluate the carcinogenic potential of 'amides, C8-18 (even-numbered) and C18-unsatd., N,N-bis(hydroxyethyl)' (in the form ofcoconut oil acid diethanolamine condensate).    Doses studied include 0, 50, or 100 mg/kg bw/d test substance (0, 85, or 170 mg/mL in ethanol). 50 male/female test animals were used in each group. 5 exposures per week were given for 104 wk. The animals were observed twice daily, body weights and clinical findings were recorded periodically. Necropsy was performed on all animals and complete histopathology was performed.   The survival rates of treated male and female rats were similar to those of the vehicle controls. The mean body weights of dosed males and females were similar to those of the vehicle controls throughout the study. The only chemical-related clinical finding was irritation of the skin at the site of application in 100 mg/kg bw/d females. There were marginal increases in the incidences of renal tubule adenoma or carcinoma (combined) in 50 mg/kg bw/d females. The severity of nephropathy increased with increasing dose in female rats.    Non neoplastic lesions of the skin at the site of application included epidermal hyperplasia, sebaceous gland hyperplasia, parakeratosis, and hyperkeratosis, and the incidences and severities of these lesions increased with increasing dose. The incidences of chronic active inflammation, epithelial hyperplasia, and epithelial ulcer of the forestomach increased with dose in female rats, and the increases were significant in the 100 mg/kg bw/d group.    Under the test conditions, there was no evidence of carcinogenic activity of the test substance in male rats administered 50 or 100 mg/kg bw/d. There was an equivocal evidence of carcinogenic activity in female rats based on a marginal increase in the incidences of renal tubule neoplasms. However, the absence of an increase in neoplasms in the 100 mg/kg bw/d group in the presence of increased hyperplasia makes the association with chemical exposure uncertain. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3133aac-f62a-49f1-8fdf-d3b95377fa60/documents/28ef7b58-24f4-4ef4-bc0c-939a62bdd88c_e6cd585c-9dde-4e0b-94eb-ec907e1b6d6c.html,,,,,, "Amides, vegetable-oil, N,N-bis(hydroxyethyl)",68155-26-0," Amides, coco, N,N-bis(hydroxyethyl) (CASRN 68603-42-9)   Wistar rats (5/sex/dose) were administered CASRN 68603-42-9 undiluted via gavage at a dose of 5000 mg/kg and observed for 14 days. No deaths occurred. LD50> 5000 mg/kg      Dodecanamide, N,N-bis(2-hydroxyethyl)- (CASRN 120-40-1) Wistar rats (5/sex/dose) were administered CASRN 120-40-1 in aqueous solution via gavage at a dose of 3500 mg/kg in an aqueous solution and observed for < 14 days. One male and two females died by day 4. LD50~3500 mg/kg A Qsar estimation on a main constituent identify a LD 50 of 10614 mg/Kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3133aac-f62a-49f1-8fdf-d3b95377fa60/documents/0f818e73-5feb-49ef-878d-c03d7f85ea07_e6cd585c-9dde-4e0b-94eb-ec907e1b6d6c.html,,,,,, "Amides, vegetable-oil, N,N-bis(hydroxyethyl)",68155-26-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3133aac-f62a-49f1-8fdf-d3b95377fa60/documents/0f818e73-5feb-49ef-878d-c03d7f85ea07_e6cd585c-9dde-4e0b-94eb-ec907e1b6d6c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Amidinourea phosphate,17675-60-4," Based on a combined repeated dose oral toxicity and reproduction/ developmental toxicity screening test with Guanylurea phosphate (GUP) in male and female Wistar rats with dose levels of 0, 100, 300, and 1000 mg/kg body weight day the following conclusions can be made. No adverse effects of test item were found on male and female clinical observations, functional observations, body weight development, food consumption, estrous cyclicity, litter data, litter weight data, pre-coital interval and duration of gestation, pre and post-natal data, reproductive indices, pup survival data, anogenital distance and nipple retention, pup thyroid weight and thyroid hormone analysis in parental males and pups sacrificed on PND 13, pup external findings, haematology and coagulation, clinical biochemistry, urinalysis, gross macroscopic findings at necropsy, organ weights and histopathology in all treatment groups.   The Systemic NOAEL of Guanylurea phosphate (GUP) in this study for general toxicity and reproductive toxicity screening is 1000 mg/kg body weight. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ad1d1ab-a474-40eb-9853-0711594a2f0d/documents/8e50a4a8-9232-4953-a132-0f3f4442b0d2_f8bdd4ce-b10e-4365-a698-060d54d185ec.html,,,,,, Amidinourea phosphate,17675-60-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ad1d1ab-a474-40eb-9853-0711594a2f0d/documents/8e50a4a8-9232-4953-a132-0f3f4442b0d2_f8bdd4ce-b10e-4365-a698-060d54d185ec.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Amidinourea phosphate,17675-60-4," Acute Oral Toxicity A single oral dose of the test item to female rats at a dose of 2000 mg/kg bw associated with signs of toxicity and mortality. The signs of toxicity recovered within up to 1-day post-dose. After this time point no signs of toxicity were visible. Rats dosed at 300 mg/kg bw showed signs of toxicity but no mortality. The signs of toxicity recovered within up to 240 minutes post-dose.The median lethal dose observed over a period of 14 days is: LD50 cut-off (rat): 2000 mg/ kg bw According to Annex I of Regulation (EC) 1272/2008 guanylurea phosphate is proposed to be classified into Category 4. Acute Dermal Toxicity Under the conditions of the present study, a single dermal application of the test item to rats at a dose of 2000 mg/kg bw was associated with no mortality and no signs of toxicity or of irritation were evident. The dermal LD50 was determined to be > 2000 mg / kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ad1d1ab-a474-40eb-9853-0711594a2f0d/documents/69a370e9-c4b2-414c-ab50-faaaf34d125b_f8bdd4ce-b10e-4365-a698-060d54d185ec.html,,,,,, Amidinourea phosphate,17675-60-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ad1d1ab-a474-40eb-9853-0711594a2f0d/documents/69a370e9-c4b2-414c-ab50-faaaf34d125b_f8bdd4ce-b10e-4365-a698-060d54d185ec.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Amidinourea phosphate,17675-60-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ad1d1ab-a474-40eb-9853-0711594a2f0d/documents/69a370e9-c4b2-414c-ab50-faaaf34d125b_f8bdd4ce-b10e-4365-a698-060d54d185ec.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Bis-[N-C13-(branched and linear)-alykl]-ammonium O,O-dipropan-2-yl phosphorodithioate",1285610-71-0,"The acute oral toxicity (LD50) was found to be greater than 2000 mg/kg (Bioassay, 10A0590/11X168, 2012) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2f60237-27af-4fae-9337-66638153e4e3/documents/IUC5-3f1d65fe-8091-4013-93d3-abe8caa4e023_27cf0033-9992-4e8c-9c58-cebe681fe084.html,,,,,, "Bis-[N-C13-(branched and linear)-alykl]-ammonium O,O-dipropan-2-yl phosphorodithioate",1285610-71-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2f60237-27af-4fae-9337-66638153e4e3/documents/IUC5-3f1d65fe-8091-4013-93d3-abe8caa4e023_27cf0033-9992-4e8c-9c58-cebe681fe084.html,,oral,LD50,"2,000 mg/kg bw",, "Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates",91745-35-6,"A 28-day and 90-day oral toxicity study in rats identified a NOAEL of 1000 mg/kg bw/day, the highest dose tested. The substance has not been tested for repeat-dose toxicity via dermal or inhalation exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b622400-8789-4fb6-886c-a28b924374da/documents/IUC5-aa07f0a7-11d3-428e-ab02-4801ae076538_1223cfea-f18e-4c1d-a833-0ce677050c4f.html,,,,,, "Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates",91745-35-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b622400-8789-4fb6-886c-a28b924374da/documents/IUC5-aa07f0a7-11d3-428e-ab02-4801ae076538_1223cfea-f18e-4c1d-a833-0ce677050c4f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates",91745-35-6,"The acute oral LD50 is >2,000 mg/kg bw.The acute dermal LD50 is >2,000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b622400-8789-4fb6-886c-a28b924374da/documents/IUC5-e0a91374-a3fd-4468-881c-e693128bb860_1223cfea-f18e-4c1d-a833-0ce677050c4f.html,,,,,, "Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates",91745-35-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b622400-8789-4fb6-886c-a28b924374da/documents/IUC5-e0a91374-a3fd-4468-881c-e693128bb860_1223cfea-f18e-4c1d-a833-0ce677050c4f.html,,oral,LD50,"2,000 mg/kg bw",, "Amines, bis(hydrogenated tallow alkyl), 2-[[bis(hydrogenated tallow alkyl)amino]carbonyl]benzoates",91745-35-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b622400-8789-4fb6-886c-a28b924374da/documents/IUC5-e0a91374-a3fd-4468-881c-e693128bb860_1223cfea-f18e-4c1d-a833-0ce677050c4f.html,,dermal,LD50,"2,000 mg/kg bw",, "Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-) (1:1)",84961-40-0," In an acute oral toxicity study conducted according to the OECD Guideline 401 in rats (BASF SE, 1981), the oral LD50 was determined to be ca. 1400 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12962c0c-c2d9-467d-83f5-027fd5bb7518/documents/f669dadd-5bbd-4086-ab26-6f7b81ed0855_94f09724-7ac3-407d-91be-ec8a3af174d4.html,,,,,, "Amines, C10-14-branched and linear alkyl, bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-) (1:1)",84961-40-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12962c0c-c2d9-467d-83f5-027fd5bb7518/documents/f669dadd-5bbd-4086-ab26-6f7b81ed0855_94f09724-7ac3-407d-91be-ec8a3af174d4.html,,oral,LD50,"1,400 mg/kg bw",adverse effect observed, "Amines, C10-14-branched and linear alkyl, bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",85029-58-9, The LD50 for acute oral toxicity was determined to be > 5000 mg/kg bw The LD50 for acute dermal toxicity was determined to be > 2500 mg/kg bw The LC50 (8h) for acute inhalation toxicity was determined to be > 2.33 mg/L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1974357-b4ab-46a1-ba93-d974b79955c1/documents/c45c9d9a-c482-47ac-8b3c-a61678ae4e86_79795b0c-7cc0-4bcf-8c50-d0b8ab50c7f5.html,,,,,, "Amines, C10-14-branched and linear alkyl, bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",85029-58-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1974357-b4ab-46a1-ba93-d974b79955c1/documents/c45c9d9a-c482-47ac-8b3c-a61678ae4e86_79795b0c-7cc0-4bcf-8c50-d0b8ab50c7f5.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Amines, C10-14-branched and linear alkyl, bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",85029-58-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1974357-b4ab-46a1-ba93-d974b79955c1/documents/c45c9d9a-c482-47ac-8b3c-a61678ae4e86_79795b0c-7cc0-4bcf-8c50-d0b8ab50c7f5.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates",80939-62-4,Oral: NOAEL = 4 mg/kg bw; rat; according to OECD TG 408; GLP; K1 Inhalation: no information available Dermal: no information available ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec0e682f-c1ff-43f0-abcf-339f1ab6d05e/documents/IUC5-325ce2e4-0186-4c91-a8b9-0d0dac0166e2_00d8ec1a-dc06-4e8d-a888-a57049a18797.html,,,,,, "Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates",80939-62-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec0e682f-c1ff-43f0-abcf-339f1ab6d05e/documents/IUC5-325ce2e4-0186-4c91-a8b9-0d0dac0166e2_00d8ec1a-dc06-4e8d-a888-a57049a18797.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,10 mg/kg bw/day,,rat "Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates",80939-62-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec0e682f-c1ff-43f0-abcf-339f1ab6d05e/documents/IUC5-325ce2e4-0186-4c91-a8b9-0d0dac0166e2_00d8ec1a-dc06-4e8d-a888-a57049a18797.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,4 mg/kg bw/day,,rat "Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates",80939-62-4,Oral: LD50 > 5000 mg/kg bw; rat; according to OECD TG 401; GLP; K1 Inhalation: no data available Dermal: LD50 > 2000 mg/kg bw; rat; according to OECD TG 402; non-GLP; K1 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec0e682f-c1ff-43f0-abcf-339f1ab6d05e/documents/IUC5-c2271054-1fd1-44d7-b863-3addb649a8c2_00d8ec1a-dc06-4e8d-a888-a57049a18797.html,,,,,, "Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates",80939-62-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec0e682f-c1ff-43f0-abcf-339f1ab6d05e/documents/IUC5-c2271054-1fd1-44d7-b863-3addb649a8c2_00d8ec1a-dc06-4e8d-a888-a57049a18797.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Amines, C11-14-branched alkyl, monohexyl and dihexyl phosphates",80939-62-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec0e682f-c1ff-43f0-abcf-339f1ab6d05e/documents/IUC5-c2271054-1fd1-44d7-b863-3addb649a8c2_00d8ec1a-dc06-4e8d-a888-a57049a18797.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amines, C12-14 (even numbered)-alkyldimethyl, N-oxides",308062-28-4,"The key study for the oral route is a 90-day repeated dose oral toxicity study in rats comparable to OECD TG 408 [Hazelton Laboratories (1974)]. The NOAEL was 0.1% (in the diet) or 1000 mg AO/kg diet. Using a food consumption factor of 0.088 kg food/kg bw/day for rats of this strain and age, this translates into a delivered dose of 88 mg AO/kg bw/day. This value represents the highest NOAEL below the lowest LOAEL and was selected for use in the risk assessment to characterize the risk of long term systemic toxicity via the oral and (by route to route extrapolation) dermal and inhalation routes. With regard to dermal toxicity, repeated dermal treatment of rats (6 hours/day/5 days/week) for 90 days with the substance at dosage levels of 0.27 % AO and 1.33 % AO revealed local signs of irritation but no effects attributable to direct systemic toxicity. A NOAEL regarding systemic effects was therefore not established. Under the conditions of the study the LOEL for local dermal toxicity (irritation) in mice was determined to be 0.27 % AO. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a921e4c-736e-4791-b937-901b176dc46c/documents/IUC5-b22926a2-4ad3-4be1-9a80-2266b89846b0_1946d7d9-601f-4d09-bd56-2df669bea0b9.html,,,,,, "Amines, C12-14 (even numbered)-alkyldimethyl, N-oxides",308062-28-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a921e4c-736e-4791-b937-901b176dc46c/documents/IUC5-b22926a2-4ad3-4be1-9a80-2266b89846b0_1946d7d9-601f-4d09-bd56-2df669bea0b9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,88 mg/kg bw/day,,rat "Amines, C12-14 (even numbered)-alkyldimethyl, N-oxides",308062-28-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a921e4c-736e-4791-b937-901b176dc46c/documents/IUC5-b22926a2-4ad3-4be1-9a80-2266b89846b0_1946d7d9-601f-4d09-bd56-2df669bea0b9.html,Repeated dose toxicity – local effects,dermal,LOAEL,0.045 mg/cm2,adverse effect observed,mouse "Amines, C12-14 (even numbered)-alkyldimethyl, N-oxides",308062-28-4,"Acute oral toxicity: Five reliable studies are available for C12-14 AO, all performed on the commercial product as supplied. In all cases, the reported LD50 values (rat) are > 2000 mg/kg bw (based on test substance). In the key study [Fulfs JC (1978)], the reported LD50 (rat) was 3800 mg/kg bw, equivalent to 1064 mg AO/kg bw. Acute dermal toxicity: The key study was performed using category member C12-18 AO. In this study the reported LD50 (rat) was > 2000 mg AO/kg bw [Haferkorn J (2010)].   Acute inhalation toxicity: No studies are available.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a921e4c-736e-4791-b937-901b176dc46c/documents/IUC5-985fbd1f-8ec3-4e5b-a856-8a740bae0c9f_1946d7d9-601f-4d09-bd56-2df669bea0b9.html,,,,,, "Amines, C12-14 (even numbered)-alkyldimethyl, N-oxides",308062-28-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a921e4c-736e-4791-b937-901b176dc46c/documents/IUC5-985fbd1f-8ec3-4e5b-a856-8a740bae0c9f_1946d7d9-601f-4d09-bd56-2df669bea0b9.html,,oral,LD50,"1,064 mg/kg bw",adverse effect observed, "Amines, C12-14 (even numbered)-alkyldimethyl, N-oxides",308062-28-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a921e4c-736e-4791-b937-901b176dc46c/documents/IUC5-985fbd1f-8ec3-4e5b-a856-8a740bae0c9f_1946d7d9-601f-4d09-bd56-2df669bea0b9.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, C12-14-(even numbered)-alkylamines,130169-56-1,"No data are available for the primary alkylamine C12-18-(even numbered)-alkylamines with regard to repeated dose toxicity. However, the 28-day oral toxicity test with (Z)-octadec-9-enylamines (Genamin OL 100 D) can be used based on read-across principles. This approach is in line with the existing EU risk assessment on primary alkylamines. Groups of five male and female rats recieved the test item by oral gavage at dose levels of 0, 3.25, 12.5 or 50 mg/kg body weight per day for a period of 28 days. At a dose of 50 mg/kg body weight per day clinical signs such as gait abnormalities, reduction in body weight gain and clinical pthology findings indicating mild toxic effects on the liver and kidneys were found. Effects observed at the mid-dose level (12.5 mg/kg) were slight reduction in growth. At the low dose group of 3.25 mg/kg body weight per day no effects were observed. Hence, the NOAEL of this study was placed at 3.25 mg/kg body weight per day. In accordance with the existing EU risk assessment on primary alkylamines, this value is considered to be valid also for C12-18-(even numbered)-alkylamines and will be used for all relevant exposures by route-to-route extrapolation for this category of chemicals. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a0fd609-09aa-412b-a8c9-5bf9b88602eb/documents/IUC5-f3c2b01c-0122-424a-8602-538a5eae982d_df464c76-709d-48a8-b328-50211479a296.html,,,,,, C12-14-(even numbered)-alkylamines,130169-56-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a0fd609-09aa-412b-a8c9-5bf9b88602eb/documents/IUC5-f3c2b01c-0122-424a-8602-538a5eae982d_df464c76-709d-48a8-b328-50211479a296.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,3.25 mg/kg bw/day,,rat C12-14-(even numbered)-alkylamines,130169-56-1,"The test material Armeen C (C12-18-(even numbered)-alkylamines) was tested for acute oral toxicity in a GLP compliant study according to OECD test guideline 401. The test item was applied via gavage to Wistar rats at doses of 500, 1000, 1500 and 2000 mg/kg body weight in peanut oil as vehicle. Clinical signs following treatment included hunched posture, apathia, uncoordinated movements, reduced reflexes, salivation, piloerection and irregular breathing. Symptoms started shortly after dosing and were present until death or up to 7 days in survivors. An LD50 of 1300 mg/kg body weight (1240 mg for male rats and 1390 mg for female rats) was calculated. With regard to acute dermal toxicity, a LD50 value of greater 2000 mg/kg body weight from a guideline conform study on C12-18-(even numbered)-alkylamines can be assumed based on read-across. Data from an inhalation study with C12-18-(even numbered)-alkylamines indicate a 1hour LC50 greater 0.099 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a0fd609-09aa-412b-a8c9-5bf9b88602eb/documents/IUC5-78d3b47d-200b-43e3-9ae1-564affdf9c2e_df464c76-709d-48a8-b328-50211479a296.html,,,,,, C12-14-(even numbered)-alkylamines,130169-56-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a0fd609-09aa-412b-a8c9-5bf9b88602eb/documents/IUC5-78d3b47d-200b-43e3-9ae1-564affdf9c2e_df464c76-709d-48a8-b328-50211479a296.html,,oral,LD50,"1,300 mg/kg bw",, C12-14-(even numbered)-alkylamines,130169-56-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a0fd609-09aa-412b-a8c9-5bf9b88602eb/documents/IUC5-78d3b47d-200b-43e3-9ae1-564affdf9c2e_df464c76-709d-48a8-b328-50211479a296.html,,dermal,LD50,"2,000 mg/kg bw",, "Amines, C12-14-alkyl, C6-10-alkyl phosphates",68603-55-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d98cd6d9-519c-4015-813a-6848c8664cd1/documents/13fadf8e-0fa5-49e2-8ecc-2843ceb98ba7_0457f260-e6a2-4fc9-be54-662eb35235e9.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,10 mg/kg bw/day,,rat "Amines, C12-14-alkyl, C6-10-alkyl phosphates",68603-55-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d98cd6d9-519c-4015-813a-6848c8664cd1/documents/6c5dbb3d-2ec3-4bcc-88d6-6136d41a0200_0457f260-e6a2-4fc9-be54-662eb35235e9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Amines, C12-14-alkyl, C6-10-alkyl phosphates",68603-55-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d98cd6d9-519c-4015-813a-6848c8664cd1/documents/6c5dbb3d-2ec3-4bcc-88d6-6136d41a0200_0457f260-e6a2-4fc9-be54-662eb35235e9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amines, C12-14-alkyl, isooctyl phosphates",68187-67-7," Acute Oral Toxicity (rat) = 200 - 2000 mg/kg bw, OECD 423 Report RCR/028/002075/AC (2000). According to the OECD 423 test guideline 1996, the LD50 cut-off value was considered to be 1000 mg/kg body weight Acute Oral Toxicity (rat) = <5000 mg/kg bw, OECD 401 Report MB 84 -7101A (1984) Acute Oral Toxicity (rat) = >5000 mg/kg bw, OECD 401 Report MB 84 -7206A (1984) Acute Dermal toxiicty (rabbit) = 2000mg/kg bw OECD 402 Report 480 -2369 (1986) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94816bff-d600-4ec9-a6be-a120f57f65c4/documents/4ac872ce-0cb4-4776-8ba4-243ce5f56556_69039bbb-262b-4182-8cda-cdda4d3a108d.html,,,,,, "Amines, C12-14-alkyl, isooctyl phosphates",68187-67-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94816bff-d600-4ec9-a6be-a120f57f65c4/documents/4ac872ce-0cb4-4776-8ba4-243ce5f56556_69039bbb-262b-4182-8cda-cdda4d3a108d.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, "Amines, C12-14-alkyl, isooctyl phosphates",68187-67-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94816bff-d600-4ec9-a6be-a120f57f65c4/documents/4ac872ce-0cb4-4776-8ba4-243ce5f56556_69039bbb-262b-4182-8cda-cdda4d3a108d.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "Amines, C12-14-alkyldimethyl",84649-84-3,"Data on repeated dose toxicity are available for C10-DMA, C12-14-DMA, C16-DMA and C18-DMA. Two studies, one with C12-14 DMA one with C16-DMA were performed according to OECD TG 408 (90 day oral toxicity studies). Other studies were performed either according to OECD TG 422, OECD TG 407 or OECD TG 421. NOAEL values from the 90-day oral toxicity studies were 75 mg/kg bw/d (C16-DMA) and 225 mg/kg bw/d (C12-14-DMA). NOAEL/NOEL values from the other studies were between 50 and 180 mg/kg bw/d. Subchronic/chronic toxicity of DMAs are also assessed based on the data on read-across source substances DMAOs. A two-year study with C10-16 DMAO is currently used as key study to cover the endpoint subchronic/chronic toxicity. The NOAEL of 42.3 and 52.6 mg/kg/d were obtained for males and females respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/961a452e-a294-4b2c-92ad-1ad26a2bfa66/documents/7cf48274-ef3f-4e20-b5d4-0c04ef57848e_b72e5095-9a10-44d2-805b-b73eef2e6e70.html,,,,,, "Amines, C12-14-alkyldimethyl",84649-84-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/961a452e-a294-4b2c-92ad-1ad26a2bfa66/documents/7cf48274-ef3f-4e20-b5d4-0c04ef57848e_b72e5095-9a10-44d2-805b-b73eef2e6e70.html,Chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Amines, C12-14-alkyldimethyl",84649-84-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): good ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/961a452e-a294-4b2c-92ad-1ad26a2bfa66/documents/ac28a97a-cd58-4fd4-86c4-eb077d73e0b3_b72e5095-9a10-44d2-805b-b73eef2e6e70.html,,,,,, "Amines, C12-14-alkyldimethyl",84649-84-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/961a452e-a294-4b2c-92ad-1ad26a2bfa66/documents/ac28a97a-cd58-4fd4-86c4-eb077d73e0b3_b72e5095-9a10-44d2-805b-b73eef2e6e70.html,,oral,LD50,"1,015 mg/kg bw",adverse effect observed, "Amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1)",68603-62-3," NOAEL (male and female systemic toxicity) = 100 mg/kg bw/d; OECD 422;  Barraclough, 2018 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fceb3c04-9441-47f3-bd16-e73f4afb085a/documents/116704da-0900-4b33-ae37-ca25c3bcf8a1_84d0c0b5-b2d5-4d2d-8dab-970d0f1015d4.html,,,,,, "Amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1)",68603-62-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fceb3c04-9441-47f3-bd16-e73f4afb085a/documents/116704da-0900-4b33-ae37-ca25c3bcf8a1_84d0c0b5-b2d5-4d2d-8dab-970d0f1015d4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Amines, C12-14-branched alkyl, dodecylbenzenesulfonates (1:1)",68603-62-3," Acute Oral Toxicity: LD50 = >2,000 mg/kg; OECD 423; (Dreher D, 2017) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fceb3c04-9441-47f3-bd16-e73f4afb085a/documents/0b815b8f-78ef-4120-a8db-323a408256e7_84d0c0b5-b2d5-4d2d-8dab-970d0f1015d4.html,,,,,, "Amines, C12-14-tert-alkyl, bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",85408-46-4," The acute oral LD50 of the test substance in rats of both sexes observed over a period of 7 days is greater than 6000 mg/kg bw. The LC50 of a 4 hour dust exposure for rats of both sexes is greater than 9500 mg/m3 air, when evaluated for a 14 day post-treatment observation period. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21ab5b4c-3297-4b6a-8cae-a1c29598a373/documents/IUC5-d0258900-cfae-48dd-b203-6437ec940876_e8d53c82-47cf-413b-991d-93b65a22d2bc.html,,,,,, "Amines, C12-14-tert-alkyl, bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",85408-46-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21ab5b4c-3297-4b6a-8cae-a1c29598a373/documents/IUC5-d0258900-cfae-48dd-b203-6437ec940876_e8d53c82-47cf-413b-991d-93b65a22d2bc.html,,oral,discriminating dose,"6,000 mg/kg bw",no adverse effect observed, "Amines, C12-14-tert-alkyl, bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",85408-46-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21ab5b4c-3297-4b6a-8cae-a1c29598a373/documents/IUC5-d0258900-cfae-48dd-b203-6437ec940876_e8d53c82-47cf-413b-991d-93b65a22d2bc.html,,inhalation,discriminating conc.,"9,500 mg/m3",no adverse effect observed, "Reaction Products of alcohols, C14-18, C18 unsat., esterified with phosphorus pentoxide and salted with amines, C12-14,-tert-alkyl",1471315-74-8,"1) An Oral Reproduction/Developmental Toxicity Screening Study in Rats, NOAEL: 150 mg/kg bw/day;2) Repeated dose toxicity, oral, 28-day, rats, NOAEL 1000 mg/kg bw/day;3) Repeated dose toxicity, oral, 14-day, rats NOAEL 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d309d75c-eac2-4b72-a038-1004a050f617/documents/IUC5-0a387b06-edf1-43d2-b62e-a902bf55433d_b5dd1266-2769-4972-a208-e93418b3df25.html,,,,,, "Reaction Products of alcohols, C14-18, C18 unsat., esterified with phosphorus pentoxide and salted with amines, C12-14,-tert-alkyl",1471315-74-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d309d75c-eac2-4b72-a038-1004a050f617/documents/IUC5-0a387b06-edf1-43d2-b62e-a902bf55433d_b5dd1266-2769-4972-a208-e93418b3df25.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Reaction Products of alcohols, C14-18, C18 unsat., esterified with phosphorus pentoxide and salted with amines, C12-14,-tert-alkyl",1471315-74-8,"1. Oral LD50 > 2000 mg/kg bw, rat, OECD420;2. Dermal LD50 > 2000 mg/kg bw, rat, OECD 402. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d309d75c-eac2-4b72-a038-1004a050f617/documents/IUC5-0665e7ab-4cca-4077-8a51-0db49743b4f3_b5dd1266-2769-4972-a208-e93418b3df25.html,,,,,, "Reaction Products of alcohols, C14-18, C18 unsat., esterified with phosphorus pentoxide and salted with amines, C12-14,-tert-alkyl",1471315-74-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d309d75c-eac2-4b72-a038-1004a050f617/documents/IUC5-0665e7ab-4cca-4077-8a51-0db49743b4f3_b5dd1266-2769-4972-a208-e93418b3df25.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Reaction Products of alcohols, C14-18, C18 unsat., esterified with phosphorus pentoxide and salted with amines, C12-14,-tert-alkyl",1471315-74-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d309d75c-eac2-4b72-a038-1004a050f617/documents/IUC5-0665e7ab-4cca-4077-8a51-0db49743b4f3_b5dd1266-2769-4972-a208-e93418b3df25.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Amines, C12-14-tert-alkyl, compds. with 2(3H)-benzothiazolethione",68911-68-2," Acute Toxicity: oral Key study The acute oral toxicity of the test material was evaluated in accordance with the techniques specified in the Regulations for the Enforcement of the Federal Hazardous Substances Act (Revised, Federal Register, September 17, 1964). The acute oral LD50 for male albino rats was found to be 1.47 mL/kg of body weight.  Confidence limits could not be calculated due to the ""all or none"" response.  The test material is classified as harmful by ingestion. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ee47c3a-c751-41e9-8852-02174e15ff01/documents/4d430878-db67-4cc6-8d06-6b538fb55e92_8a776556-1259-4943-9138-9a116859fce2.html,,,,,, "Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates",96690-34-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Hazard assessment is conducted by means of read-across from a structural analogue/surrogate. The selected study is the most adequate and reliable study based on the identified similarities in structure and intrinsic properties between source and target substance and overall assessment of quality, duration and dose. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d646d564-9c87-42bb-bfa1-f132c7044cad/documents/01cb2d47-d20a-4905-bc22-22b91a56ae1e_50e40712-51bc-46b3-8524-4bbf8f1b211e.html,,,,,, "Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates",96690-34-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d646d564-9c87-42bb-bfa1-f132c7044cad/documents/01cb2d47-d20a-4905-bc22-22b91a56ae1e_50e40712-51bc-46b3-8524-4bbf8f1b211e.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,10 mg/kg bw/day,,rat "Amines, C12-14-tert-alkyl, mixed sec-Bu and iso-Bu phosphates",96690-34-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d646d564-9c87-42bb-bfa1-f132c7044cad/documents/IUC5-cfc10133-0474-4bc8-a465-68b64b782144_50e40712-51bc-46b3-8524-4bbf8f1b211e.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "Amines, C12-18-(even numbered) and C18-(unsaturated) alkyl",2156592-58-2,"No data are available for the primary alkylamine C12-18-(even numbered)-alkylamines with regard to repeated dose toxicity. However, the 28-day oral toxicity test with (Z)-octadec-9-enylamines (Genamin OL 100 D) can be used based on read-across principles. This approach is in line with the existing EU risk assessment on primary alkylamines. Groups of five male and female rats recieved the test item by oral gavage at dose levels of 0, 3.25, 12.5 or 50 mg/kg body weight per day for a period of 28 days. At a dose of 50 mg/kg body weight per day clinical signs such as gait abnormalities, reduction in body weight gain and clinical pthology findings indicating mild toxic effects on the liver and kidneys were found. Effects observed at the mid-dose level (12.5 mg/kg) were slight reduction in growth. At the low dose group of 3.25 mg/kg body weight per day no effects were observed. Hence, the NOAEL of this study was placed at 3.25 mg/kg body weight per day. In accordance with the existing EU risk assessment on primary alkylamines, this value is considered to be valid also for C12-18-(even numbered)-alkylamines and will be used for all relevant exposures by route-to-route extrapolation for this category of chemicals. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec0c71b8-caa3-4f48-8ea4-53321cf2c55d/documents/IUC5-40e13735-af97-4fd6-8729-123a562f6ab2_50d08477-4939-4be3-ac82-43ef02c1a3c8.html,,,,,, "Amines, C12-18-(even numbered) and C18-(unsaturated) alkyl",2156592-58-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec0c71b8-caa3-4f48-8ea4-53321cf2c55d/documents/IUC5-40e13735-af97-4fd6-8729-123a562f6ab2_50d08477-4939-4be3-ac82-43ef02c1a3c8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,3.25 mg/kg bw/day,,rat "Amines, C12-18-(even numbered) and C18-(unsaturated) alkyl",2156592-58-2,"The test material Armeen C (C12-18-(even numbered)-alkylamines) was tested for acute oral toxicity in a GLP compliant study according to OECD test guideline 401. The test item was applied via gavage to Wistar rats at doses of 500, 1000, 1500 and 2000 mg/kg body weight in peanut oil as vehicle. Clinical signs following treatment included hunched posture, apathia, uncoordinated movements, reduced reflexes, salivation, piloerection and irregular breathing. Symptoms started shortly after dosing and were present until death or up to 7 days in survivors. An LD50 of 1300 mg/kg body weight (1240 mg for male rats and 1390 mg for female rats) was calculated. With regard to acute dermal toxicity, a LD50 value of greater 2000 mg/kg body weight from a guideline conform study on C12-18-(even numbered)-alkylamines can be assumed based on read-across. Data from an inhalation study with C12-18-(even numbered)-alkylamines indicate a 1hour LC50 greater 0.099 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec0c71b8-caa3-4f48-8ea4-53321cf2c55d/documents/IUC5-4651c847-cd70-4f0c-a465-0e542a425d0a_50d08477-4939-4be3-ac82-43ef02c1a3c8.html,,,,,, "Amines, C12-18-(even numbered) and C18-(unsaturated) alkyl",2156592-58-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec0c71b8-caa3-4f48-8ea4-53321cf2c55d/documents/IUC5-4651c847-cd70-4f0c-a465-0e542a425d0a_50d08477-4939-4be3-ac82-43ef02c1a3c8.html,,oral,LD50,"1,300 mg/kg bw",, "Amines, C12-18-(even numbered) and C18-(unsaturated) alkyl",2156592-58-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec0c71b8-caa3-4f48-8ea4-53321cf2c55d/documents/IUC5-4651c847-cd70-4f0c-a465-0e542a425d0a_50d08477-4939-4be3-ac82-43ef02c1a3c8.html,,dermal,LD50,"2,000 mg/kg bw",, "Amines, C12-18-alkyldimethyl",68391-04-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): good ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d9eefc0-bcd5-4fb5-a85d-a791b2748510/documents/d7eec889-9269-470f-a6b6-acc62a9d3845_47036d4e-3ee7-4ab4-a8aa-50c6dae4edc7.html,,,,,, "Amines, C12-18-alkyldimethyl",68391-04-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d9eefc0-bcd5-4fb5-a85d-a791b2748510/documents/d7eec889-9269-470f-a6b6-acc62a9d3845_47036d4e-3ee7-4ab4-a8aa-50c6dae4edc7.html,Chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Amines, C12-18-alkyldimethyl",68391-04-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): good ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d9eefc0-bcd5-4fb5-a85d-a791b2748510/documents/6bce1d58-f7eb-44f2-8777-03ab551751ed_47036d4e-3ee7-4ab4-a8aa-50c6dae4edc7.html,,,,,, "Amines, C12-18-alkyldimethyl",68391-04-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d9eefc0-bcd5-4fb5-a85d-a791b2748510/documents/6bce1d58-f7eb-44f2-8777-03ab551751ed_47036d4e-3ee7-4ab4-a8aa-50c6dae4edc7.html,,oral,LD50,"1,015 mg/kg bw",adverse effect observed, "Amines, C12-18(even numbered)-alkyldimethyl, N-oxides",68955-55-5,"The key study for the oral route is a 90-day repeated dose oral toxicity study in rats comparable to OECD TG 408 [Hazelton Laboratories (1974)] performed with C12-14 AO. The NOAEL was 0.1% (in the diet) or 1000 mg AO/kg diet. Using a food consumption factor of 0.088 kg food/kg bw/day for rats of this strain and age, this translates into a delivered dose of 88 mg AO/kg bw/day. This value represents the highest NOAEL below the lowest LOAEL and was selected for use in the risk assessment to characterize the risk of long term systemic toxicity via the oral and (by route to route extrapolation) dermal and inhalation routes.With regard to dermal toxicity, repeated dermal treatment of rats (6 hours/day/5 days/week) for 90 days with C12-14 AO at dosage levels of 0.27 % AO and 1.33 % AO revealed local signs of irritation but no effects attributable to direct systemic toxicity. A NOAEL regarding systemic effects was therefore not established. Under the conditions of the study the LOEL for local dermal toxicity (irritation) in mice was determined to be 0.27 % AO. Based on application of 0.27 mg AO via a patch of size 2x3 cm, this is equivalent to 0.045 mg AO/cm². ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2423f50c-5000-4830-9431-d0bc160f1a4d/documents/IUC5-95aac1da-f879-4697-96c6-23fc4393f802_b5ea9f99-c63c-454b-91cf-38cf2f31b7cb.html,,,,,, "Amines, C12-18(even numbered)-alkyldimethyl, N-oxides",68955-55-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2423f50c-5000-4830-9431-d0bc160f1a4d/documents/IUC5-95aac1da-f879-4697-96c6-23fc4393f802_b5ea9f99-c63c-454b-91cf-38cf2f31b7cb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,88 mg/kg bw/day,,rat "Amines, C12-18(even numbered)-alkyldimethyl, N-oxides",68955-55-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2423f50c-5000-4830-9431-d0bc160f1a4d/documents/IUC5-95aac1da-f879-4697-96c6-23fc4393f802_b5ea9f99-c63c-454b-91cf-38cf2f31b7cb.html,Repeated dose toxicity – local effects,dermal,LOAEL,0.045 mg/cm2,adverse effect observed,mouse "Amines, C12-18(even numbered)-alkyldimethyl, N-oxides",68955-55-5,"Acute oral toxicity: Two reliable studies are available for C12-18 AO and six for C12-14 AO, all performed on the commercial product as supplied. In all cases, the reported LD50 values (rat) are > 2000 mg/kg bw (based on test substance). In the key study [Rupprich N & Weigand W (1983)], the reported LD50 (rat, female) was 2820 mg/kg bw, equivalent to 846 mg AO/kg bw.Acute dermal toxicity: Two reliable studies are available. In the key study performed using C12-18 alkyl dimethylamine oxide, the reported LD50 (rat) was > 2000 mg AO/kg bw [Haferkorn J (2010)].Acute inhalation toxicity: No studies are available. The substance is a solid with very low vapour pressure. It is manufactured and supplied as an aqueous solution therefore there is no possibility of exposure to dust. It is used in some spraying applications, but it is expected that inhalation exposure from these applications will be low and hence the dermal route is more relevant. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2423f50c-5000-4830-9431-d0bc160f1a4d/documents/IUC5-38ecdf37-9b76-4e2f-a568-80e725efd9b2_b5ea9f99-c63c-454b-91cf-38cf2f31b7cb.html,,,,,, "Amines, C12-18(even numbered)-alkyldimethyl, N-oxides",68955-55-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2423f50c-5000-4830-9431-d0bc160f1a4d/documents/IUC5-38ecdf37-9b76-4e2f-a568-80e725efd9b2_b5ea9f99-c63c-454b-91cf-38cf2f31b7cb.html,,oral,LD50,846 mg/kg bw,adverse effect observed, "Amines, C12-18(even numbered)-alkyldimethyl, N-oxides",68955-55-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2423f50c-5000-4830-9431-d0bc160f1a4d/documents/IUC5-38ecdf37-9b76-4e2f-a568-80e725efd9b2_b5ea9f99-c63c-454b-91cf-38cf2f31b7cb.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Amines, C16-18 and C18-unsatd. alkyl",68037-95-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0d907b9-d025-4d2c-b2af-2ff3f2e5d6bd/documents/IUC5-55704b02-d81b-4278-b6e2-29a0615955d8_5cd9d634-212f-47c2-8639-f031e2e586ae.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,3.25 mg/kg bw/day,,rat "Amines, C16-18 and C18-unsatd. alkyl",68037-95-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0d907b9-d025-4d2c-b2af-2ff3f2e5d6bd/documents/IUC5-e09b6e55-dbab-4927-80e9-26010248e7df_5cd9d634-212f-47c2-8639-f031e2e586ae.html,,oral,LD50,"2,000 mg/kg bw",, "Amines, C16-18 and C18-unsatd. alkyl",68037-95-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0d907b9-d025-4d2c-b2af-2ff3f2e5d6bd/documents/IUC5-e09b6e55-dbab-4927-80e9-26010248e7df_5cd9d634-212f-47c2-8639-f031e2e586ae.html,,dermal,LD50,"2,000 mg/kg bw",, "Amines, C16-18-alkyl",90640-32-7,"No data are available for the primary alkylamine hydrogenated alkylamines with regard to repeated dose toxicity. However, the 28-day oral toxicity test with (Z)-octadec-9-enylamines (Genamin OL 100 D) can be used based on read-across principles. This approach is in line with the existing EU risk assessment on primary alkylamines. Groups of five male and female rats recieved the test item by oral gavage at dose levels of 0, 3.25, 12.5 or 50 mg/kg body weight per day for a period of 28 days. At a dose of 50 mg/kg body weight per day clinical signs such as gait abnormalities, reduction in body weight gain and clinical pthology findings indicating mild toxic effects on the liver and kidneys were found. Effects observed at the mid-dose level (12.5 mg/kg) were slight reduction in growth. At the low dose group of 3.25 mg/kg body weight per day no effects were observed. Hence, the NOAEL of this study was placed at 3.25 mg/kg body weight per day. In accordance with the existing EU risk assessment on primary alkylamines, this value is considered to be valid also for hydrogenated tallow alkylamines and will be used for all relevant exposures by route-to-route extrapolation for this category of chemicals. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05518709-b853-4fbe-b8a1-39df14d263f0/documents/IUC5-43d1fed4-c873-406f-90d2-646c3c42dc15_89c75db9-7c12-4ee0-a19c-563e3f289883.html,,,,,, "Amines, C16-18-alkyl",90640-32-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05518709-b853-4fbe-b8a1-39df14d263f0/documents/IUC5-43d1fed4-c873-406f-90d2-646c3c42dc15_89c75db9-7c12-4ee0-a19c-563e3f289883.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,3.25 mg/kg bw/day,,rat "Amines, C16-18-alkyl",90640-32-7,"The test material Lilamin AC-HBG-P (hydrogenated tallow alkylamines) was tested for acute oral toxicity in a GLP compliant study according to OECD test guideline 401. The test item was applied via gavage to Wistar rats in a limit test at 5000 mg/kg body weight as a suspension in methylcellulose. Clinical signs following treatment included diarrhea, piloerection, hunched posture and abnormal git.. Body weights were initially reduced but body weight gain was not different from controls. No treatment related effects were observed at necropsy. The LD50 was greater 5000 mg/kg body weight. With regard to acute dermal toxicity, a LD50 value of greater 2000 mg/kg body weight from a guideline conform study on C12-18-(even numbered)-alkylamines can be assumed based on read-across. Data from an inhalation study with C12-18-(even numbered)-alkylamines indicate a 1hour LC50 greater 0.099 mg/L and will be used as read-across. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05518709-b853-4fbe-b8a1-39df14d263f0/documents/IUC5-29b3bfb0-dbea-4dd5-aa19-4ebac4d62caf_89c75db9-7c12-4ee0-a19c-563e3f289883.html,,,,,, "Amines, C16-18-alkyl",90640-32-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05518709-b853-4fbe-b8a1-39df14d263f0/documents/IUC5-29b3bfb0-dbea-4dd5-aa19-4ebac4d62caf_89c75db9-7c12-4ee0-a19c-563e3f289883.html,,oral,LD50,"5,000 mg/kg bw",, "Amines, C16-18-alkyl",90640-32-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05518709-b853-4fbe-b8a1-39df14d263f0/documents/IUC5-29b3bfb0-dbea-4dd5-aa19-4ebac4d62caf_89c75db9-7c12-4ee0-a19c-563e3f289883.html,,dermal,LD50,"2,000 mg/kg bw",, C16-18-(even numbered)-alkylamines acetates,1273322-45-4,"Only limited data are available for the registration substance C16-18-(even numbered)-alkylamines acetates with regard to repeated dose toxicity. However, 14-day extended dose-range-finder screening studies, have illustrated clear consistencies in the systemic toxicity profile of alkylamine acetates and their corresponding alkyl amines following repeated oral exposure. Therefore the 28-day oral toxicity test with C16-18-(even numbered, saturated and unsaturated)- alkylamines can be used for hazard and risk characterization purposes based on read-across principles. Groups of five male and female rats received the test item by oral gavage at dose levels of 0, 3.25, 12.5 or 50 mg/kg body weight per day for a period of 28 days. At a dose of 50 mg/kg body weight per day clinical signs such as gait abnormalities, reduction in body weight gain and clinical pathology findings indicating mild toxic effects on the liver and kidneys were found. Effects observed at the mid dose level (12.5 mg/kg) were slight reduction in growth. At the low dose group of 3.25 mg/kg body weight per day no effects were observed. Hence, the NOAEL of this study was placed at 3.25 mg/kg body weight per day. This value is considered to be conservative but valid also for C16-18-(even numbered)-alkylamine acetates and will be used for all relevant exposures by route-to-route extrapolation for the registration substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5bea04fa-ce4f-45e5-8f67-4bdea18c5c14/documents/IUC5-b00173e0-e239-4da4-b51f-014cf700216f_b3e335c9-fe56-4e04-b7b4-6aa178013400.html,,,,,, C16-18-(even numbered)-alkylamines acetates,1273322-45-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5bea04fa-ce4f-45e5-8f67-4bdea18c5c14/documents/IUC5-b00173e0-e239-4da4-b51f-014cf700216f_b3e335c9-fe56-4e04-b7b4-6aa178013400.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,3.25 mg/kg bw/day,,rat C16-18-(even numbered)-alkylamines acetates,1273322-45-4,"There are no human data on acute toxicity for the test item. In animals, test results with this substance are available for the oral route of exposure indicating a LD50 cut-off value of 5000 mg/kg body weight. With regard to the dermal route of exposure, results from analogous primary alkylamines revealed a LD50 greater 2000 mg/kg body weight. Testing of the inhalation route is waived based on the physico-chemical characteristics ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5bea04fa-ce4f-45e5-8f67-4bdea18c5c14/documents/IUC5-e2cd473d-7e43-496b-ae43-2994555ec1a7_b3e335c9-fe56-4e04-b7b4-6aa178013400.html,,,,,, C16-18-(even numbered)-alkylamines acetates,1273322-45-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5bea04fa-ce4f-45e5-8f67-4bdea18c5c14/documents/IUC5-e2cd473d-7e43-496b-ae43-2994555ec1a7_b3e335c9-fe56-4e04-b7b4-6aa178013400.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Amines, C16-18-alkyldimethyl",68390-97-6,"Data on repeated dose toxicity are available for C10-DMA, C12-14-DMA, C16-DMA and C18-DMA. These studies were performed either according to OECD TG 422, OECD TG 407 or OECD TG 421. NOAEL/NOEL of between 50 and 180 mg/kg/d were obtained. Subchronic/chronic toxicity of DMAs are assessed based on the data on read-across source substances DMAOs. A two-year study with C10-16 DMAO is currently used as key study to cover the endpoint subchronic/chronic toxicity. The NOAEL of 42.3 and 52.6 mg/kg/d were obtained for males and females respectively. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): good ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ef4d5d1-c689-4cb8-b2b2-2c80c0ec76f4/documents/3987824b-51ed-4e55-83bc-b89b8c77bed2_844f2d18-6dfd-4b2d-9c54-2d8b49b8477b.html,,,,,, "Amines, C16-18-alkyldimethyl",68390-97-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ef4d5d1-c689-4cb8-b2b2-2c80c0ec76f4/documents/3987824b-51ed-4e55-83bc-b89b8c77bed2_844f2d18-6dfd-4b2d-9c54-2d8b49b8477b.html,Chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Amines, C16-18-alkyldimethyl",68390-97-6,"Reliable data from several guideline studies on acute toxicity after oral application are available for C10-DMA, C12-DMA, C12-14-DMA, C14-DMA, C16-DMA, C12-18-DMA, and C18-DMA. These data reveal low acute oral toxicity of the DMAs of this category: LD50 values for all investigated test items in rats are between 1015 mg/kg bw (C16-DMA) and >2000 mg/kg bw (C10-DMA, C12-14-DMA, C18-DMA) which is the upper limit for classification. No tendency related to increasing carbon chain length is observed. No data on acute toxicity after inhalation and dermal exposure are available. As key value the most conservative value for the category members is selected. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): good ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ef4d5d1-c689-4cb8-b2b2-2c80c0ec76f4/documents/094bcbbb-ff34-43a7-9968-898ae143212a_844f2d18-6dfd-4b2d-9c54-2d8b49b8477b.html,,,,,, "Amines, C16-18-alkyldimethyl",68390-97-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ef4d5d1-c689-4cb8-b2b2-2c80c0ec76f4/documents/094bcbbb-ff34-43a7-9968-898ae143212a_844f2d18-6dfd-4b2d-9c54-2d8b49b8477b.html,,oral,LD50,"1,015 mg/kg bw",adverse effect observed, "Amines, C16-22-alkyl",68037-92-3,"One repeated dose-range finding study over 14 days and two full 28 day oral toxicity studies are available on C16-22-(even numbered)alkylamines (CAS no 68037-92-3). They are all performed under GLP and have reliability rating 1.  The one available repeated dose oral toxicity study performed at the lowest doses on C16-22-(even numbered)alkylamines (CAS no 68037-92-3) was chosen as key study, identifying the lowest dose of 3.5 mg/kg bw as a LOAEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce8d6ec3-dc76-40f1-83b3-c8f7947549c4/documents/ef434ec7-54b9-4250-98b1-66fb1a3c3ffb_86d83a5f-003b-403d-ada9-db3b806dfa6c.html,,,,,, "Amines, C16-22-alkyl",68037-92-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce8d6ec3-dc76-40f1-83b3-c8f7947549c4/documents/ef434ec7-54b9-4250-98b1-66fb1a3c3ffb_86d83a5f-003b-403d-ada9-db3b806dfa6c.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,3.5 mg/kg bw/day,,rat "Amines, C16-22-alkyl",68037-92-3,"The available acute oral test on C16-22-(even numbered)alkylamines (CAS no 68037-92-3) indicates GHS classification as acute oral toxicity category 5 (LD50 between 2000 and 5000 mg/kg). No data is available on acute toxicity via inhalation or dermal route.In the available oral acute toxicity study two groups, each of three female WISTAR Crl: WI(Han) rats, were treated with a single oral application of the test item by oral gavage at an administrative dose of 2000 mg/kg body weight. The test item was emulsified with the vehicle sesame oil at a concentration of 0.2 g/mL and administered at a dose volume of 10 mL/kg. The most relevant clinical findings in the animals treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity and piloerection. Throughout the 14-day observation period, the weight gain of the animals was within the normal range of variation for this strain. At necropsy, no macroscopic findings were observed in any of the six animals in the two steps. On the basis of the test results given above and in conformity with the criteria given in Annex VI to Commission Directive 2001/59/EC the test item C16-22-(even numbered)alkylamines (CAS no 68037-92-3)  has no obligatory labelling requirement for acute toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce8d6ec3-dc76-40f1-83b3-c8f7947549c4/documents/da1ebd90-1a09-4211-9942-33b2986f00cf_86d83a5f-003b-403d-ada9-db3b806dfa6c.html,,,,,, "Amines, C16-22-alkyl",68037-92-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce8d6ec3-dc76-40f1-83b3-c8f7947549c4/documents/da1ebd90-1a09-4211-9942-33b2986f00cf_86d83a5f-003b-403d-ada9-db3b806dfa6c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Amines, C20-22-alkyldimethyl",93164-85-3,"Full details of these endpoints are provided in the IUCLID dossier and they are considered reliable. The substance is considered ""Harmful if swallowed"" (Acute tox 4).Waiving was done according to ANNEX VII colum2 of the REACH regulation: the available information regarding skin irritation indicates that the criteria for classification as corrosive for the skin is met ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e89a3cb-412e-4ee7-b350-f8cf28498c5a/documents/IUC5-93d2f518-4c1a-43ed-a1e8-c482ed3273cb_bab14b83-66ce-4d6f-b2c7-269257ba4da3.html,,,,,, "Amines, C36-alkylenedi-",68955-56-6,"For C36-alkylenediamine an OECD 422 study is available, involving the dosing of males up to 29 days and female animals up to 43-57 days. A NOAEL of 50 mg/kg was derived from this study, based on effects observed of foamy macrophages in the mesenteric lymphnodes appearing as the first effect at low dose and in lamina propria of intestines at increasing dose levels. This effect is also referred to as phospholipidosis, and is considered at its lowest severity to be a local effect, as consequence to route of exposure. Only from 500 mg/kg an increased WBC was the only additional toxic effect observed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7de7f95-110c-432f-9bd8-04095cfb308c/documents/IUC5-6a79578e-be3b-46cf-af38-96e7d87240ea_a18aab2d-d94d-40b3-be47-f7ed3c9b1e4a.html,,,,,, "Amines, C36-alkylenedi-",68955-56-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7de7f95-110c-432f-9bd8-04095cfb308c/documents/IUC5-6a79578e-be3b-46cf-af38-96e7d87240ea_a18aab2d-d94d-40b3-be47-f7ed3c9b1e4a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Amines, C36-alkylenedi-",68955-56-6,"Acute oral toxicity: Read-across to long-chain primary alkyl amines of which toxicity is expected to be comparable (with respect to local effects) to higher (with respect to systemic toxicity due to lower absorption) compared to Dimerdiamine. The acute oral LD50 of Hydrogenated tallow > 5000 mg/kg bw. A 14-day study for Dimerdiamine at 1000 mg/kg bw/day lead to the mortality of 2/6 animals, and in view of the large difference between acute dose levels and repeated dose levels leading to toxicity, an oral LD50 > 2000 mg/kg bw can also be expected for Dimerdiamine.There is no information available on acute toxicity via inhalation.Acute dermal toxicity: Read-across to Coco-alkylamine with an LD50 > 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7de7f95-110c-432f-9bd8-04095cfb308c/documents/IUC5-ed38e860-6e53-405b-b2b7-c7d60311c8a0_a18aab2d-d94d-40b3-be47-f7ed3c9b1e4a.html,,,,,, "Amines, C36-alkylenedi-",68955-56-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7de7f95-110c-432f-9bd8-04095cfb308c/documents/IUC5-ed38e860-6e53-405b-b2b7-c7d60311c8a0_a18aab2d-d94d-40b3-be47-f7ed3c9b1e4a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amines, C36-alkylenedi-",68955-56-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7de7f95-110c-432f-9bd8-04095cfb308c/documents/IUC5-ed38e860-6e53-405b-b2b7-c7d60311c8a0_a18aab2d-d94d-40b3-be47-f7ed3c9b1e4a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amines, di-C12-18-alkylmethyl",68439-75-8,"The acute oral toxicity of the substance was assessed using:- An acute oral toxicity limit test performed in rats according to OECD 401 guideline and Good Laboratory Practices (Hoechst, 1990).The substance is of low  acute toxicity following oral exposure:The oral LD0  was found to be greater than 2000 mg/kg bw in both sexes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7b0c80a-adb6-48b6-ab2d-9557d18e3181/documents/IUC5-0cc188bc-5ed7-4343-9226-a8733ddd8998_04caf650-8f0e-4562-a595-5759a315d3bb.html,,,,,, "Amines, di-C12-18-alkylmethyl",68439-75-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7b0c80a-adb6-48b6-ab2d-9557d18e3181/documents/IUC5-0cc188bc-5ed7-4343-9226-a8733ddd8998_04caf650-8f0e-4562-a595-5759a315d3bb.html,,oral,LD50,"2,000 mg/kg bw",, N-(C16-C18)alkyl(C16-C18)alkane-1-amine,308062-60-4,"A 90 day oral dosing study according to OECD Guideline 408 with Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4) is available, with reliability rating 1. The results seen in the study, leads to a NOAEL of 5 mg/kg bw based on granulomatous inflammation in the mesenteric lymph nodes observed at an increased severity and incidence at the higher dose levels. These findings are also present in the available 28 day study on the same substance, where similar effects were seen at higher doses. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5289b86b-214d-49a5-bd3a-8abc49f9cfc2/documents/IUC5-9a548fee-d8da-4c0b-a17d-69eb01df4e8a_46118ac3-0105-4995-ba62-e5121d977337.html,,,,,, N-(C16-C18)alkyl(C16-C18)alkane-1-amine,308062-60-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5289b86b-214d-49a5-bd3a-8abc49f9cfc2/documents/IUC5-9a548fee-d8da-4c0b-a17d-69eb01df4e8a_46118ac3-0105-4995-ba62-e5121d977337.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat N-(C16-C18)alkyl(C16-C18)alkane-1-amine,308062-60-4,"Two acute studies are available on Amines, di-C16-18 (even-numbered) alkyl (CAS No. 308062-60-4), one on acute oral toxicity and one on acute dermal toxicity. The oral LD50 study on Amines, bis(hydrogenated tallow alkyl) CAS No 61789 -79 -5 has reliability rating 2 and is compliant to OECD Guideline 401. The reason for the reliability rating 2 is the study was performed pre-GLP in 1987 and no specific certificate of analysis or information on batch is included in the report. The result from this study is considered to be reliable, since the product tested has not changed significantly in its composition since the testing was carried out. Therefore the results are considered valid for the current manufactured Amines, bis(hydrogenated tallow alkyl) CAS No 61789 -79 -5 and the study will be used for classification of the substance. The dermal LD50 study (OECD Guideline 402) on Amines, bis(hydrogenated tallow alkyl) CAS No 61789 -79 -5 study has reliability 1 GLP . ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5289b86b-214d-49a5-bd3a-8abc49f9cfc2/documents/IUC5-45073619-6d19-42fe-b51d-3e735598e5a1_46118ac3-0105-4995-ba62-e5121d977337.html,,,,,, N-(C16-C18)alkyl(C16-C18)alkane-1-amine,308062-60-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5289b86b-214d-49a5-bd3a-8abc49f9cfc2/documents/IUC5-45073619-6d19-42fe-b51d-3e735598e5a1_46118ac3-0105-4995-ba62-e5121d977337.html,,oral,LD50,"5,000 mg/kg bw",, N-(C16-C18)alkyl(C16-C18)alkane-1-amine,308062-60-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5289b86b-214d-49a5-bd3a-8abc49f9cfc2/documents/IUC5-45073619-6d19-42fe-b51d-3e735598e5a1_46118ac3-0105-4995-ba62-e5121d977337.html,,dermal,LD50,"2,000 mg/kg bw",, N-methyl-di-C16-18-(even numbered)-alkylamines,1227096-04-9,"The acute oral toxicity of the substance was assessed using:-2 acute oral toxicity limit tests performed in rats according to OECD 401 guideline and Good Laboratory Practices (Kynoch, 1984 and Hoechst, 1988a)The substance is of low acute toxicity following oral exposure:The oral LD0 was found to be greater than 2000 mg/kg bw in both sexes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ba8faca-ef71-427b-8c67-95ba0e299bb1/documents/3cfb03e0-a0f4-4dc2-8a9e-17dc1a91aed1_af25be2b-f0bf-4a73-b628-7c620c2e9a3a.html,,,,,, N-methyl-di-C16-18-(even numbered)-alkylamines,1227096-04-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ba8faca-ef71-427b-8c67-95ba0e299bb1/documents/3cfb03e0-a0f4-4dc2-8a9e-17dc1a91aed1_af25be2b-f0bf-4a73-b628-7c620c2e9a3a.html,,oral,LD50,"2,000 mg/kg bw",, "N-(3-aminopropyl)-N'-C16-18 (evennumbered), C18 unsaturated alkyl -propane-1,3-diamine",1219458-14-6,"90 day oral (OECD 408, GLP): NOAEL 2.5 mg/kg bw/day based on foamy macrophage infiltration in the ileum and jejunum. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b8a19b9c-9d99-49d1-98f5-e5a6029bdf4c/documents/IUC5-44353e33-8326-4de8-9282-b9d072f840f2_fe305e69-0233-4e62-a372-4f1f549d5d93.html,,,,,, "N-(3-aminopropyl)-N'-C16-18 (evennumbered), C18 unsaturated alkyl -propane-1,3-diamine",1219458-14-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b8a19b9c-9d99-49d1-98f5-e5a6029bdf4c/documents/IUC5-44353e33-8326-4de8-9282-b9d072f840f2_fe305e69-0233-4e62-a372-4f1f549d5d93.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,2.5 mg/kg bw/day,,rat "N-(3-aminopropyl)-N'-C16-18 (evennumbered), C18 unsaturated alkyl -propane-1,3-diamine",1219458-14-6,Acute toxicity: Oral LD50 between 300 and 2000 mg/kg for rat (LD50 cut-off: 500 mg/kg bw)No data is available on acute toxicity via inhalation or dermal route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8a19b9c-9d99-49d1-98f5-e5a6029bdf4c/documents/IUC5-edc795c5-40f6-4421-bf8f-34323d02cbc2_fe305e69-0233-4e62-a372-4f1f549d5d93.html,,,,,, "N-(3-aminopropyl)-N'-C16-18 (evennumbered), C18 unsaturated alkyl -propane-1,3-diamine",1219458-14-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8a19b9c-9d99-49d1-98f5-e5a6029bdf4c/documents/IUC5-edc795c5-40f6-4421-bf8f-34323d02cbc2_fe305e69-0233-4e62-a372-4f1f549d5d93.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "Not assignable, UVCB",1229648-98-9,"The potential toxicity of the substance following repeated administration was investigated according to OECD guideline 422 and EPA guideline OPPTS 870.3650 (Davies, 2010a). The NOAEL by oral route was established to 15 mg/kg bw/day.No Repeated-dose toxicity studies by inhalation or dermal route were available. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/42df0c7b-c470-42f3-a768-e096dc1e090f/documents/IUC5-9a3f5c68-382e-4969-94da-24e823343594_57ebb16d-a766-4201-a103-096e1764b4eb.html,,,,,, "Not assignable, UVCB",1229648-98-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/42df0c7b-c470-42f3-a768-e096dc1e090f/documents/IUC5-9a3f5c68-382e-4969-94da-24e823343594_57ebb16d-a766-4201-a103-096e1764b4eb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "Not assignable, UVCB",1229648-98-9,"The acute oral toxicity of the substance was assessed using:- 2 acute oral toxicity tests performed in rats. The study of Dufour was carried out according to OECD 401 guideline and Good Laboratory Practices (Dufour, 1997). The study of Petra was older and conducted according to a method similar to OECD 401 guideline. Very few information on the tested substance were reported (Petra, 1981)Based on these data, the substance is of moderate acute toxicity following oral exposure:The oral LD50 was 704 mg/kg bw in rats.No dermal and inhalation toxicity studies were performed on the substance due to its corrosive properties. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42df0c7b-c470-42f3-a768-e096dc1e090f/documents/IUC5-ad8d3749-843c-45bb-b9bf-d445dc4d6e4f_57ebb16d-a766-4201-a103-096e1764b4eb.html,,,,,, "Not assignable, UVCB",1229648-98-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42df0c7b-c470-42f3-a768-e096dc1e090f/documents/IUC5-ad8d3749-843c-45bb-b9bf-d445dc4d6e4f_57ebb16d-a766-4201-a103-096e1764b4eb.html,,oral,LD50,704 mg/kg bw,, "N-C16-18-alkyl-(evennumbered, C18 unsaturated) trimethylpropane-1,3-diamine",1275611-65-8," In a GLP-compliant guideline 90-day oral study with rats, combined with reproductive/developmental toxicity screening, the lowest tested level of 1 mg/kg bw/day was considered to be a LOAEL, based on the presence of granulomatous inflammation of the mesenteric lymph nodes with central necrosis at all dose levels with dose-related increase in severity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09eba31a-3005-4e66-aebd-fbfa1456b73a/documents/cd60d842-ed4f-4ee5-b174-b53decb11bde_6e335be0-ce20-45e6-b1f7-0c3ada7ba7a0.html,,,,,, "N-C16-18-alkyl-(evennumbered, C18 unsaturated) trimethylpropane-1,3-diamine",1275611-65-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09eba31a-3005-4e66-aebd-fbfa1456b73a/documents/cd60d842-ed4f-4ee5-b174-b53decb11bde_6e335be0-ce20-45e6-b1f7-0c3ada7ba7a0.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,1 mg/kg bw/day,,rat "N-C16-18-alkyl-(evennumbered, C18 unsaturated) trimethylpropane-1,3-diamine",1275611-65-8, Available studies result to GHS classification Category 3 for acute oral toxicity (LD50 between 50 and 300 mg/kg bw) with a LD50 cut-off of 200 mg/kg bw. No data available on acute toxicity via inhalation or dermal route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09eba31a-3005-4e66-aebd-fbfa1456b73a/documents/22602e68-3a04-433b-a01d-6963d8b74148_6e335be0-ce20-45e6-b1f7-0c3ada7ba7a0.html,,,,,, "N-C16-18-alkyl-(evennumbered, C18 unsaturated) trimethylpropane-1,3-diamine",1275611-65-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09eba31a-3005-4e66-aebd-fbfa1456b73a/documents/22602e68-3a04-433b-a01d-6963d8b74148_6e335be0-ce20-45e6-b1f7-0c3ada7ba7a0.html,,oral,LD50,200 mg/kg bw,adverse effect observed, "Amines,N-(C16-18 and C18 unsaturated alkyl) trimethylenedi-,diacetates.",1313206-64-2," No study is available for Amines, N-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, diacetates. Subchronic toxicity studies are available for : (Z)-1-(octadec-9-enylammonio)propane-3-ammonium diacetate (CAS 7173-67-3): - 14d range-finder (GLP): LOAEL = 7 mg/kg bw/day (corresponding to 5 mg/kg bw/day in terms of oleyl diamine) (Z)-N-9-octadecenyl-1,3-diaminopropane (CAS 7173-62-8): - 14d range-finder (GLP): NOAEL = 2 mg/kg bw/day - 14d study (GLP): LOAEL = 12.5 mg/kg bw/day - 28d (OECD 407, GLP): NOAEL = 1.25 mg/kg bw/day  N-C12,14 alkyl-1, 3-diamino propane (CAS 90640-43-0): - Key study : 90d (OECD 408, GLP) - NOAEL = 0.4 mg/kg bw/day (corresponding to 0.7 mg/kg bw of Amines, N-(C16-18 and C18-unsatd. alkyl)trimethylenedi-, diacetates). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e09d289-beb5-4364-917c-f559611095ad/documents/4e8bd1f8-cacd-4594-b6f8-b1d15a263b3c_60d99dfe-e5f8-4e30-a992-cf02cd3fda3c.html,,,,,, "Amines,N-(C16-18 and C18 unsaturated alkyl) trimethylenedi-,diacetates.",1313206-64-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e09d289-beb5-4364-917c-f559611095ad/documents/4e8bd1f8-cacd-4594-b6f8-b1d15a263b3c_60d99dfe-e5f8-4e30-a992-cf02cd3fda3c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.7 mg/kg bw/day,,rat "Amines,N-(C16-18 and C18 unsaturated alkyl) trimethylenedi-,diacetates.",1313206-64-2,The most recent and reliable study results to classification in Category 4 for acute oral toxicity (LD50 between 300 and 2000 mg/kg bw) in accordance with Regulation (EC) No 1272/2008. Acute dermal toxicity LD50 is > 2000 mg/kg bw on the basis of read-across with existing data on diamines compounds. There is no data available on acute toxicity via inhalation. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e09d289-beb5-4364-917c-f559611095ad/documents/d4e515a9-d4de-46e1-825e-e28e6bd1274a_60d99dfe-e5f8-4e30-a992-cf02cd3fda3c.html,,,,,, "Amines,N-(C16-18 and C18 unsaturated alkyl) trimethylenedi-,diacetates.",1313206-64-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e09d289-beb5-4364-917c-f559611095ad/documents/d4e515a9-d4de-46e1-825e-e28e6bd1274a_60d99dfe-e5f8-4e30-a992-cf02cd3fda3c.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "Amines,N-(C16-18 and C18 unsaturated alkyl) trimethylenedi-,diacetates.",1313206-64-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e09d289-beb5-4364-917c-f559611095ad/documents/d4e515a9-d4de-46e1-825e-e28e6bd1274a_60d99dfe-e5f8-4e30-a992-cf02cd3fda3c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amines, N-C16-C18-alkyl-(evennumbered, C18 unsaturated) propane-1,3-diaminium di[(9Z)-octadec-9-enoate]",1307863-78-0," 28 day oral (OECD 407, GLP): NOAEL 5 mg/kg bw/day read-across from Oleyl-diamine dioleate. Read-across from C12-14-alkyl-diamine: 90 day oral (OECD 408, GLP): NOAEL 0.4 mg C12-14-diamine/kg bw/day, equivalent to 1.1 mg Tallow-diamine dioleate/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26362600-b45d-4eb3-b429-313e7eca5602/documents/IUC5-8f16ff9f-85c5-4bbe-b8e8-a180c315bb52_5c9d0292-f49e-45d1-9d3e-c0056c11a895.html,,,,,, "Amines, N-C16-C18-alkyl-(evennumbered, C18 unsaturated) propane-1,3-diaminium di[(9Z)-octadec-9-enoate]",1307863-78-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26362600-b45d-4eb3-b429-313e7eca5602/documents/IUC5-8f16ff9f-85c5-4bbe-b8e8-a180c315bb52_5c9d0292-f49e-45d1-9d3e-c0056c11a895.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,1 mg/kg bw/day,,rat "Amines, N-C16-C18-alkyl-(evennumbered, C18 unsaturated) propane-1,3-diaminium di[(9Z)-octadec-9-enoate]",1307863-78-0,"An acute oral toxicity study with Tallow-diamine dioleate resulted to an LD50 > 5000 mg/kg, and one acute dermal study with Oleyl-diamine dioleate resulting to an LD50 > 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26362600-b45d-4eb3-b429-313e7eca5602/documents/IUC5-709c816e-a15c-49ba-84e4-701312616dbc_5c9d0292-f49e-45d1-9d3e-c0056c11a895.html,,,,,, "Amines, N-C16-C18-alkyl-(evennumbered, C18 unsaturated) propane-1,3-diaminium di[(9Z)-octadec-9-enoate]",1307863-78-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26362600-b45d-4eb3-b429-313e7eca5602/documents/IUC5-709c816e-a15c-49ba-84e4-701312616dbc_5c9d0292-f49e-45d1-9d3e-c0056c11a895.html,,oral,discriminating dose,"5,000 mg/kg bw",adverse effect observed, "Amines, N-C16-C18-alkyl-(evennumbered, C18 unsaturated) propane-1,3-diaminium di[(9Z)-octadec-9-enoate]",1307863-78-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26362600-b45d-4eb3-b429-313e7eca5602/documents/IUC5-709c816e-a15c-49ba-84e4-701312616dbc_5c9d0292-f49e-45d1-9d3e-c0056c11a895.html,,dermal,discriminating dose,"2,000 mg/kg bw",adverse effect observed, "Amines, N-(C16-18 (even numbered) and C18-unsatd. alkyl) trimethylenedi-, ethoxylated(NLP)",1290049-56-7,"Based on Read-across  from Oleyl-diamine3EO: 28 day oral (OECD 407, GLP): NOAEL 1 mg/kg bw/dayRead-across from C12/14-alkyl-diamine: 90 day oral (OECD 408, GLP): NOAEL 0.4 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f604b5f-480e-452c-af34-b40a160d79bf/documents/IUC5-eed5048a-fd79-4423-b684-9450a165331e_1aedca23-2f53-4ade-8c3f-e487448f96b5.html,,,,,, "Amines, N-(C16-18 (even numbered) and C18-unsatd. alkyl) trimethylenedi-, ethoxylated(NLP)",1290049-56-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f604b5f-480e-452c-af34-b40a160d79bf/documents/IUC5-eed5048a-fd79-4423-b684-9450a165331e_1aedca23-2f53-4ade-8c3f-e487448f96b5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.4 mg/kg bw/day,,rat "Amines, N-(C16-18 (even numbered) and C18-unsatd. alkyl) trimethylenedi-, ethoxylated(NLP)",1290049-56-7,Available studies result to GHS classification Category 4 for acute oral toxicity (LD50 between 300 and 2000 mg/kg bw) with a LD50 cut-off of 500 mg/kg bw.No data available on acute toxicity via inhalation or dermal route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f604b5f-480e-452c-af34-b40a160d79bf/documents/IUC5-2e19a9d8-1119-4421-9d30-ac3a65536325_1aedca23-2f53-4ade-8c3f-e487448f96b5.html,,,,,, "Amines, N-(C16-18 (even numbered) and C18-unsatd. alkyl) trimethylenedi-, ethoxylated(NLP)",1290049-56-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f604b5f-480e-452c-af34-b40a160d79bf/documents/IUC5-2e19a9d8-1119-4421-9d30-ac3a65536325_1aedca23-2f53-4ade-8c3f-e487448f96b5.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "Amines, N-(C18 unsaturated, alkyl) trimethylenedi-, ethoxylated (NLP)",1268344-02-0, A 28 -day oral gavage study in rat (OECD 422) with Oleyl-diamine3EO resulted to a NOAEL of 1 mg/kg bw/day. Read-across from 90 -day oral gave study in rat (OECD 408) with C12/14-alkyl-diamine results to a NOAEL 0.4 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf5c1352-27bf-4389-96cc-1424d4277727/documents/IUC5-c2012680-841d-4e11-bc0d-178ac71ab1b2_8050bf8c-b74e-48e2-bb83-b9ddc797969a.html,,,,,, "Amines, N-(C18 unsaturated, alkyl) trimethylenedi-, ethoxylated (NLP)",1268344-02-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf5c1352-27bf-4389-96cc-1424d4277727/documents/IUC5-c2012680-841d-4e11-bc0d-178ac71ab1b2_8050bf8c-b74e-48e2-bb83-b9ddc797969a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.4 mg/kg bw/day,,rat "Amines, N-(C18 unsaturated, alkyl) trimethylenedi-, ethoxylated (NLP)",1268344-02-0, Available studies result to GHS classification Category 4 for acute oral toxicity (LD50 between 300 and 2000 mg/kg bw) with a LD50 cut-off of 500 mg/kg bw. No data available on acute toxicity via inhalation or dermal route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf5c1352-27bf-4389-96cc-1424d4277727/documents/IUC5-3700feea-bbe3-49d7-8e19-31512d42c573_8050bf8c-b74e-48e2-bb83-b9ddc797969a.html,,,,,, "Amines, N-(C18 unsaturated, alkyl) trimethylenedi-, ethoxylated (NLP)",1268344-02-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf5c1352-27bf-4389-96cc-1424d4277727/documents/IUC5-3700feea-bbe3-49d7-8e19-31512d42c573_8050bf8c-b74e-48e2-bb83-b9ddc797969a.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "Amines, N-C10-16-alkyltrimethylenedi-, reaction products with chloroacetic acid",139734-65-9," Chronic study; oral (diet), mouse (CD-1; 50/sex/dose), OECD TG 453, GLP; NOAEL(males) = 2 mg a.i./kg bw/day, LOAEL(females) = 4 mg a.i./kg bw/day; no NOAEL identified for females Subchronic study; oral (gavage), rat (Sprague Dawley, Crl: CD(SD)BR; 10/sex/dose), EPA OPP 82-1, GLP; NO(A)EL = 2.5 mg a.i./kg bw/day Subchronic study; oral (diet), mouse (CD-1; 10/sex/dose), OECD TG 453, GLP (dose-range finder for Combined chronic toxicity/carcinogenicity study); NOAEL = 12 mg a.i./kg bw/day Subchronic study; oral (gavage), dog (Beagle; 4/sex/dose), OECD TG 409, GLP; NOAEL = 5 mg a.i./kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c2e6ea9-1a36-4048-a121-fd44cf7a13d6/documents/IUC5-2c6aa9ee-9c75-4ec2-93ba-d08bb7fa0927_ce5f340d-b853-4a1f-a403-74346c3332b9.html,,,,,, "Amines, N-C10-16-alkyltrimethylenedi-, reaction products with chloroacetic acid",139734-65-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c2e6ea9-1a36-4048-a121-fd44cf7a13d6/documents/IUC5-2c6aa9ee-9c75-4ec2-93ba-d08bb7fa0927_ce5f340d-b853-4a1f-a403-74346c3332b9.html,Chronic toxicity – systemic effects,oral,NOAEL,2 mg/kg bw/day,,mouse "Amines, N-C10-16-alkyltrimethylenedi-, reaction products with chloroacetic acid",139734-65-9," Acute oral toxicity: LD50 (rat, female) > 300 mg/kg bw; LD50 cut-off 500 mg/kg bw (OECD 423) Acute inhalation toxicity: no relevant route of exposure Acute dermal toxicity: LD50 (rat) > 2000 mg a.i./kg bw (OECD guideline 402 + extrapolation from acute oral toxicity study/toxicokinetic data) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c2e6ea9-1a36-4048-a121-fd44cf7a13d6/documents/IUC5-8153c49e-5d54-44e9-a266-9fc1a1117e36_ce5f340d-b853-4a1f-a403-74346c3332b9.html,,,,,, "Amines, N-C10-16-alkyltrimethylenedi-, reaction products with chloroacetic acid",139734-65-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c2e6ea9-1a36-4048-a121-fd44cf7a13d6/documents/IUC5-8153c49e-5d54-44e9-a266-9fc1a1117e36_ce5f340d-b853-4a1f-a403-74346c3332b9.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, "Amines, N-C10-16-alkyltrimethylenedi-, reaction products with chloroacetic acid",139734-65-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c2e6ea9-1a36-4048-a121-fd44cf7a13d6/documents/IUC5-8153c49e-5d54-44e9-a266-9fc1a1117e36_ce5f340d-b853-4a1f-a403-74346c3332b9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amines, N-C12-14-alkyltrimethylenedi-",90640-43-0," 28 day oral (OECD 407, GLP): NOAEL 0.4 mg/kg bw/day 90 day oral (OECD 408, GLP): NOAEL 0.4 mg/kg bw/day No study available for inhalation or dermal exposure: N-C12,14 alkyl-1,3-diaminopropane is a fluid/paste with mp of 27°C and has a vapour pressure of 0.0015 Pa at 20°C. Its use is limited to industrial and professional users and does not involve the forming of aerosols, particles or droplets of an inhalable size. So exposure to humans via the inhalation route will be unlikely to occur. N-C12,14 alkyl-1,3-diaminopropane is corrosive to the skin and is not expected to easily pass the skin. The skin is therefore not a preferred route when studying repeated dose systemic toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d8a1783-d954-4070-b51c-185313c5999f/documents/04b0d0aa-516f-466e-b216-3c72a10fbb23_1341fa6e-3c41-4aba-a7ce-886dff0592ab.html,,,,,, "Amines, N-C12-14-alkyltrimethylenedi-",90640-43-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d8a1783-d954-4070-b51c-185313c5999f/documents/04b0d0aa-516f-466e-b216-3c72a10fbb23_1341fa6e-3c41-4aba-a7ce-886dff0592ab.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.4 mg/kg bw/day,,rat "Amines, N-C12-14-alkyltrimethylenedi-",90640-43-0, Available studies result to GHS classification Category 3 for acute oral toxicity (LD50 between 50 and 300 mg/kg bw) with a LD50 cut-off of 200 mg/kg bw. No data available on acute toxicity via inhalation or dermal route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d8a1783-d954-4070-b51c-185313c5999f/documents/d6a82ba9-8adf-4f01-b4b7-970704515855_1341fa6e-3c41-4aba-a7ce-886dff0592ab.html,,,,,, "Amines, N-C12-14-alkyltrimethylenedi-",90640-43-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d8a1783-d954-4070-b51c-185313c5999f/documents/d6a82ba9-8adf-4f01-b4b7-970704515855_1341fa6e-3c41-4aba-a7ce-886dff0592ab.html,,oral,LD50,200 mg/kg bw,adverse effect observed, "Amines, N-C12-18-alkyltrimethylenedi-",68155-37-3," Coco-diamine: 15 day oral gavage: NOAEL: 6 mg/kg bw/day C12-14-diamine: 28 day oral gavage (OECD 407, GLP): NOAEL 0.4 mg/kg bw/day C12-14-diamine: 90 day oral gavage (OECD 408, GLP): NOAEL 0.4 mg/kg bw/day No study available for inhalation or dermal exposure: N-C12-18-alkyl-1,3-diaminopropane is a liquid/paste with no inhalable particles and a vapour pressure of 0.0015 Pa at 20°C (value based on read-across from C12-14-diamine showing almost similar average molecule weight). Also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. N-C12-18-alkyl-1,3-diaminopropane is corrosive to the skin and is not expected to easily pass the skin. The skin is therefore not a preferred route when studying repeated dose systemic toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11238b1a-4db7-4141-8abc-3113403de6c1/documents/IUC5-16d87e37-1803-4d4d-8699-95e40c12abd0_0ddae0e1-df6a-450e-9599-c6fd57e718b3.html,,,,,, "Amines, N-C12-18-alkyltrimethylenedi-",68155-37-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11238b1a-4db7-4141-8abc-3113403de6c1/documents/IUC5-16d87e37-1803-4d4d-8699-95e40c12abd0_0ddae0e1-df6a-450e-9599-c6fd57e718b3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.4 mg/kg bw/day,,rat "Amines, N-C12-18-alkyltrimethylenedi-",68155-37-3, Available studies result to GHS classification Category 3 for acute oral toxicity (LD50 between 50 and 300 mg/kg bw) with a LD50 cut-off of 300 mg/kg bw. Acute dermal toxicity LD50 is > 2000 mg/kgbw. There is no data available on acute toxicity via inhalation. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11238b1a-4db7-4141-8abc-3113403de6c1/documents/IUC5-5bf1735a-97a5-4191-b186-946370414e14_0ddae0e1-df6a-450e-9599-c6fd57e718b3.html,,,,,, "Amines, N-C12-18-alkyltrimethylenedi-",68155-37-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11238b1a-4db7-4141-8abc-3113403de6c1/documents/IUC5-5bf1735a-97a5-4191-b186-946370414e14_0ddae0e1-df6a-450e-9599-c6fd57e718b3.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "Amines, N-C12-18-alkyltrimethylenedi-",68155-37-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11238b1a-4db7-4141-8abc-3113403de6c1/documents/IUC5-5bf1735a-97a5-4191-b186-946370414e14_0ddae0e1-df6a-450e-9599-c6fd57e718b3.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts",2098351-38-1," Based on the generated data from the available OECD 422 study on Coco iminodiglycinate, (Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts with CAS no 2098351-38-1) in rats, the NOAEL of 675.50 mg a.i./kg bw/day has been used for the derivation of DNEL values to be used in the risk assessment. The study is performed according to OECD 422 guideline and under GLP and has reliability rating 1.   The test item was administered daily in graduated doses to 3 groups of test animals, one dose level per group for a treatment period of a maximum of 63 days, i.e. during 14 days of pre-mating and maximum 14 days of mating in both males and females, during the gestation period and up to post-natal day 12 in females. Males were dosed after the mating period until the minimum total dosing period of 28 days was completed. Animals of an additional control group were handled identically as the dose groups but received sterile water, the vehicle used in this study. The 4 groups comprised 10 male and 10 female Wistar rats.   The following doses were evaluated: Control (C):                0           mg/kg body weight/day Low Dose (LD):          67.55    mg/kg body weight/day Medium Dose (MD):   202.65  mg/kg body weight/day High Dose (HD):         675.50  mg/kg body weight/day   The dose levels referred to active ingredient Coco iminodiglycinate, (Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts with CAS no 2098351-38-1). In order to correct for the purity of 40.8 % of active ingredient, the test material was weighed under consideration of a correction factor of 2.451. Dose volumes were adjusted individually based on the body weight most recently measured. The administration volume was 5 mL/kg body weight.   Available endpoint data within the substance group covers the smallest (shortest alky, lowest number amine and carboxymethylated groups, CAS no2098351-38-1) as well as the biggest structure (longest alkyl-unsaturated, highest number amine and carboxymethylated groups, CAS no 2060541-49-1) within the amphoteric, glycinate group. The NOAEL values from these two studies are comparable, but the study on Coco iminodiglycinate, (Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts with CAS no 2098351-38-1) is identified to have the lowest NOAEL value. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6ff183d-5264-4d59-a981-a37bb43a93da/documents/180984f6-3237-41b0-8a98-710787997b26_e76c102f-409f-4898-8145-990e005b28cf.html,,,,,, "Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts",2098351-38-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6ff183d-5264-4d59-a981-a37bb43a93da/documents/180984f6-3237-41b0-8a98-710787997b26_e76c102f-409f-4898-8145-990e005b28cf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,675.5 mg/kg bw/day,,rat "Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts",2098351-38-1," For all of the four substances within the amphoteric glycinate substance group there are available acute oral toxicity data. The endpoint data covers the smallest (shortest alky, lowest number amine and carboxymethylated groups, CAS no 2098351-38-1) as well as the biggest structure (longest alkyl-unsaturated, highest number amine and carboxymethylated groups, CAS no 2060541-49-1) within the group. The studies have been performed under GLP and according to current OECD 401 guideline. In all of the studies the maximum dose tested was 5000 mg/kg bw on the technical products. As the technical products consists of approximately 40 % active ingredient, it is estimated that doses corresponding to 2000 mg a.i./kg bw were tested. The LD50 values are therefore considered to be > 2000 mg a.i./kg bw and no classification for acute oral toxicity is therefore required according to CLP.   No toxic effects were seen within this dose range for any of the tested substances. This is also in line with the QSAR predictions available on this group of structures. ACD ToxSuite indicates LD50 values > 2000 mg/kg bw for all of the four substances. Within a category of structures the acute toxicity is decreased for longer chain lengths, but increased for alkyl chains with higher unsaturation. This is also predicted by the QSAR models. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6ff183d-5264-4d59-a981-a37bb43a93da/documents/7196f151-e3cf-41c1-9e38-f13cb3349adc_e76c102f-409f-4898-8145-990e005b28cf.html,,,,,, "Amines, N-C12-18-alkyltrimethylenedi-, reaction products with chloroacetic acid, sodium salts",2098351-38-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6ff183d-5264-4d59-a981-a37bb43a93da/documents/7196f151-e3cf-41c1-9e38-f13cb3349adc_e76c102f-409f-4898-8145-990e005b28cf.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amines, N-C16-18-alkyl (evennumbered) propane-1,3-diamine",133779-11-0," C12-14-diamine: 28 day oral gavage (OECD 407, GLP): NOAEL 0.4 mg/kg bw/day C12-14-diamine: 90 day oral gavage (OECD 408, GLP): NOAEL 0.4 mg/kg bw/day No study available for inhalation or dermal exposure:   N-C16-18-alkyl (evennumbered)-1,3-diaminepropane (N-(hydrogenated tallow alkyl) trimethylenediamine also abbreviated to HT-diamine) is a solid (pellets) with mp of 43°C, with no inhalable particles (0.11% (m/m) with particle size < 100 μm) and a vapour pressure less than 0.0015 Pa at 20°C (value is an overestimation as it is based on read-across from shorter chain C12-14-diamine). Also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. The substance is severely irritatingto the skin and is not expected to easily pass the skin. The skin is therefore not a preferred route when studying repeated dose systemic toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b01f475-8d7c-454e-93ac-1cefe2628f5a/documents/IUC5-6eac9f59-4dc2-417b-859a-1963ea80b5a8_beb81b2b-17af-4f21-baef-3efe30a530d8.html,,,,,, "Amines, N-C16-18-alkyl (evennumbered) propane-1,3-diamine",133779-11-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b01f475-8d7c-454e-93ac-1cefe2628f5a/documents/IUC5-6eac9f59-4dc2-417b-859a-1963ea80b5a8_beb81b2b-17af-4f21-baef-3efe30a530d8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.4 mg/kg bw/day,,rat "Amines, N-C16-18-alkyl (evennumbered) propane-1,3-diamine",133779-11-0, Low acute toxicity via oral route with LD50cut-off of 2500 mg/kg bw; limited exposure via inhalation; study by dermal route not necessary due to low systemic toxicity and severe dermal irritation. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b01f475-8d7c-454e-93ac-1cefe2628f5a/documents/IUC5-d75b8b3c-4448-4d4d-b127-d3f0d83eaaf4_beb81b2b-17af-4f21-baef-3efe30a530d8.html,,,,,, "Amines, N-C16-18-alkyl (evennumbered) propane-1,3-diamine",133779-11-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b01f475-8d7c-454e-93ac-1cefe2628f5a/documents/IUC5-d75b8b3c-4448-4d4d-b127-d3f0d83eaaf4_beb81b2b-17af-4f21-baef-3efe30a530d8.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, "Amines, N-C16-22-alkyltrimethylenedi-",90640-45-2,"Based on the results of the short-term repeated-dose toxicity study conducted on the regitered substance to comply with Annex VIII of REACH, the NOAEL for general toxicity was considered to be 75 mg/kg/day for both males and females animals via the oral route. Data on toxicity of other members of the diamine category following a repeated exposure via the oral route are available and can be used as part of the assessment of Amines, N-C16-22-alkyltrimethylenedi-. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70fcfb88-7d57-4cc4-9171-b342d6655796/documents/a4a7bf30-a7cb-4158-a80a-31fcf1138142_9e719543-d305-40e2-a04f-534810886f6e.html,,,,,, "Amines, N-C16-22-alkyltrimethylenedi-",90640-45-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70fcfb88-7d57-4cc4-9171-b342d6655796/documents/a4a7bf30-a7cb-4158-a80a-31fcf1138142_9e719543-d305-40e2-a04f-534810886f6e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat "Amines, N-C16-22-alkyltrimethylenedi-",90640-45-2,"The substance is classified as corrosive to the skin, Category 1B. Therefore, in accordance with Annexes VII and VIII of REACH, no acute toxicity testing is required for the registered substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70fcfb88-7d57-4cc4-9171-b342d6655796/documents/125bdfc9-18f4-4bcf-ade5-d3c95a3f96e5_9e719543-d305-40e2-a04f-534810886f6e.html,,,,,, "Amines, N-coco alkyltrimethylenedi-, acetates",61791-64-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cff44a2a-fd86-4194-91fc-d4845b4b47c0/documents/163c3514-ca0c-4a3a-bafa-36711f5c34ef_5659c402-1b24-4298-b36d-f609bed34238.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amines, N-tallow alkyltrimethylenedi-, propoxylated",68603-75-8,"The potential toxicity of the substance following repeated administration was investigated using:- a 28-day repeated-dose toxicity with a 2 week recovery period performed by oral route in rats according to a method comparable to OECD 407 guideline and in compliance with Good Laboratory Practices (Avril, 1981e)- a combined repeated-dose oral toxicity study with the reproduction/developmental toxicity screening test in rat with the structurally closely related substance 2-Propanol, 1,1'-[[3-[(3-aminopropyl)amino]propyl]imino]bis-, N-tallow alkyl derivs. The study was conducted according to OECD guideline 422 and EPA guideline OPPTS 870.3650 in compliance with Good Laboratory Practices (Takawale, 2010a read across from Polyram SL).The NOAEL by oral route was established to 24 mg/kg bw/day.No Repeated-dose toxicity studies by inhalation or dermal route were available. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2ea3e7a-d0ff-4081-8c56-28b88a576869/documents/IUC5-8ce4594f-05b9-46fb-8a4d-601e383b9b2b_a67daeea-e728-463e-a95d-aa3bd7b08552.html,,,,,, "Amines, N-tallow alkyltrimethylenedi-, propoxylated",68603-75-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2ea3e7a-d0ff-4081-8c56-28b88a576869/documents/IUC5-8ce4594f-05b9-46fb-8a4d-601e383b9b2b_a67daeea-e728-463e-a95d-aa3bd7b08552.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,24 mg/kg bw/day,,rat "Amines, N-tallow alkyltrimethylenedi-, propoxylated",68603-75-8,"The acute oral toxicity of the substance was assessed using:- an acute oral toxicity test performed in rats according to a method similar to OECD 401 guideline. Very few information on the tested substance were reported and only male rats were used in the study (Gobron, 1981a).Based on this study, the substance is of moderate acute toxicity following oral exposure:The oral LD50 was 1255 mg/kg bw in male rats.No dermal and inhalation toxicity studies were performed on the substance due to its corrosive properties. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2ea3e7a-d0ff-4081-8c56-28b88a576869/documents/IUC5-0c020eb2-4c8f-49dd-ad43-064f98edde4b_a67daeea-e728-463e-a95d-aa3bd7b08552.html,,,,,, "Amines, N-tallow alkyltrimethylenedi-, propoxylated",68603-75-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2ea3e7a-d0ff-4081-8c56-28b88a576869/documents/IUC5-0c020eb2-4c8f-49dd-ad43-064f98edde4b_a67daeea-e728-463e-a95d-aa3bd7b08552.html,,oral,LD50,"1,255 mg/kg bw",, "Amines, polyethylenepoly-",68131-73-7," No studies are available for PEPA. A 90 -day study according to OECD 408 inlcuding a developmental/reproduction screening is ongoing. As soon as the data is available the dossier will be updated. In the meanwhile the following interim data is used. Reliable data from the structural analogue TETA (CAS 112 -24 -3) and TETA-2HCl (CAS 38260 -01 -4) are available and used as interim approach and considered reliable to evaluate the repeated dose toxicity of PEPA. LOAEL (rat, oral, chronic) = 50 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0386ef61-f44d-4667-88aa-27688115ec24/documents/d0f98bbe-3291-4aff-83b2-9d4e6f40ab26_1d9d6312-4fcb-43e4-931b-7a6fddc29ece.html,,,,,, "Amines, polyethylenepoly-",68131-73-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0386ef61-f44d-4667-88aa-27688115ec24/documents/d0f98bbe-3291-4aff-83b2-9d4e6f40ab26_1d9d6312-4fcb-43e4-931b-7a6fddc29ece.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,50 mg/kg bw/day,,rat "Amines, polyethylenepoly-",68131-73-7," No data are available on the acute oral toxicity and only limited data on acute dermal toxicity of PEPA. However, the registered substance is corrosive and is harmonised classified as 'harmul if swallowed and in contact with skin'. Therefore, no further testing is required according to the standard information requirements in Annex VII and VIII of the Reach Regulation. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0386ef61-f44d-4667-88aa-27688115ec24/documents/8ee0465b-f374-4e2b-a196-68666e8f57cb_1d9d6312-4fcb-43e4-931b-7a6fddc29ece.html,,,,,, "Amines, polyethylenepoly-, tetraethylenepentamine fraction",90640-66-7,"Only insufficient data with Amines, polyethylenepoly-, tetraethylenepentamine fraction regarding repeated dose toxicity by oral route are available. A 90-day study according to OECD 408 including a developmental/reproduction screening is ongoing. As soon as the data is available the dossier will be updated. Therefore, studies with the structural analogue substance TETA-2HCl (CAS 38260 -01 -4) are used and considered reliable to evaluate the repeated dose toxicity of Amines, polyethylenepoly-, tetraethylenepentamine fraction. LOAEL (TETA-2HCl, rat, oral, subchronic) = 50 mg/kg bw/day Reliable data regarding repeated dose toxicity by dermal route is available: NOAEL (OECD 410, rabbit, dermal, subacute) systemic >= 200 mg/kg bw/day, local = 1.25 mg/cm² ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ec240ea-9881-4d21-9cee-ed84a2006ea5/documents/77c6be5c-b386-48a9-91d9-1c9528c0d463_1bd5b970-dd54-40e9-a3ab-5f4347cf0a06.html,,,,,, "Amines, polyethylenepoly-, tetraethylenepentamine fraction",90640-66-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ec240ea-9881-4d21-9cee-ed84a2006ea5/documents/77c6be5c-b386-48a9-91d9-1c9528c0d463_1bd5b970-dd54-40e9-a3ab-5f4347cf0a06.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,200 mg/kg bw/day,,rabbit "Amines, polyethylenepoly-, tetraethylenepentamine fraction",90640-66-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ec240ea-9881-4d21-9cee-ed84a2006ea5/documents/77c6be5c-b386-48a9-91d9-1c9528c0d463_1bd5b970-dd54-40e9-a3ab-5f4347cf0a06.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,50 mg/kg bw/day,,rat "Amines, polyethylenepoly-, tetraethylenepentamine fraction",90640-66-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ec240ea-9881-4d21-9cee-ed84a2006ea5/documents/77c6be5c-b386-48a9-91d9-1c9528c0d463_1bd5b970-dd54-40e9-a3ab-5f4347cf0a06.html,Repeated dose toxicity – local effects,dermal,NOAEL,1.25 mg/cm2,adverse effect observed,rabbit "Amines, polyethylenepoly-, tetraethylenepentamine fraction",90640-66-7,"oral (similar to OECD 401, rat, RL2): LD50 = 3221 mg/kg bw   dermal (similar to OECD 402, rabbit, RL2): LD50 = 1260 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ec240ea-9881-4d21-9cee-ed84a2006ea5/documents/IUC5-45dd65a0-9b00-4ee5-9357-6aec9c887a25_1bd5b970-dd54-40e9-a3ab-5f4347cf0a06.html,,,,,, "Amines, polyethylenepoly-, tetraethylenepentamine fraction",90640-66-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ec240ea-9881-4d21-9cee-ed84a2006ea5/documents/IUC5-45dd65a0-9b00-4ee5-9357-6aec9c887a25_1bd5b970-dd54-40e9-a3ab-5f4347cf0a06.html,,oral,LD50,"3,221 mg/kg bw",adverse effect observed, "Amines, polyethylenepoly-, tetraethylenepentamine fraction",90640-66-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ec240ea-9881-4d21-9cee-ed84a2006ea5/documents/IUC5-45dd65a0-9b00-4ee5-9357-6aec9c887a25_1bd5b970-dd54-40e9-a3ab-5f4347cf0a06.html,,dermal,LD50,"1,260 mg/kg bw",adverse effect observed, "Amines, polyethylenepoly-, triethylenetetramine fraction",90640-67-8,"Only insufficient data with Amines, polyethylenepoly-, triethylenetetramine fraction are available. A 90-day study according to OECD 408 including a developmental/reproduction screening is ongoing. As soon as the data is available the dossier will be updated. Therefore, studies with the structural analogue substance TETA-2HCl (CAS 38260 -01 -4) are used as interim approach and considered reliable to evaluate the repeated dose toxicity of Amines, polyethylenepoly-, triethylenetetramine fraction.   LOAEL (TETA-2HCl, rat, oral, subchronic) = 50 mg/kg bw/day; recalculation for Amines, polyethylenepoly-, triethylenetetramine fraction based on molecular weight results in a LOAEL of 33 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19cd9f97-e65c-43d4-8eab-70a4c9be10fc/documents/11f920f5-5673-4a0d-863d-25d43c870fb6_dd255198-8083-4fbf-a0f3-0ec19adb01c1.html,,,,,, "Amines, polyethylenepoly-, triethylenetetramine fraction",90640-67-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19cd9f97-e65c-43d4-8eab-70a4c9be10fc/documents/11f920f5-5673-4a0d-863d-25d43c870fb6_dd255198-8083-4fbf-a0f3-0ec19adb01c1.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,33 mg/kg bw/day,,rat "Amines, polyethylenepoly-, triethylenetetramine fraction",90640-67-8,"Based on the results from the Acute Exposure Oral Toxicity in rats, the acute oral LD50 for males, females and combined sexes was determined to be 1861.9 (1383.5 - 2505.7) mg/kg bw, 1591.4 (1283.5 - 1973.3) mg/kg be and 1716.2 (1446.5 - 2036.1) mg/kg bw, respectively. No valid data available for acute inhalation toxicity that can be used for classification and labelling; the studies performed were intended to examine the toxicity of the vapour under realistic exposure conditions. Based on the observations made in the Acute Exposure Dermal Toxicity Study in rabbits, the acute dermal LD50 in males and combined sexes was determined to be 1720.0 (1082.9-2732.0) mg/kg bw and 1465.4 (1074.6-1998.3) mg/kg bw, respectively. The data generated for the acute dermal LD50 in females did not lend itself to the statistical method employed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19cd9f97-e65c-43d4-8eab-70a4c9be10fc/documents/IUC5-351c3181-f800-47fe-a295-c8339e74aedd_dd255198-8083-4fbf-a0f3-0ec19adb01c1.html,,,,,, "Amines, polyethylenepoly-, triethylenetetramine fraction",90640-67-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19cd9f97-e65c-43d4-8eab-70a4c9be10fc/documents/IUC5-351c3181-f800-47fe-a295-c8339e74aedd_dd255198-8083-4fbf-a0f3-0ec19adb01c1.html,,oral,LD50,"1,716 mg/kg bw",adverse effect observed, "Amines, polyethylenepoly-, triethylenetetramine fraction",90640-67-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19cd9f97-e65c-43d4-8eab-70a4c9be10fc/documents/IUC5-351c3181-f800-47fe-a295-c8339e74aedd_dd255198-8083-4fbf-a0f3-0ec19adb01c1.html,,dermal,LD50,"1,465 mg/kg bw",adverse effect observed, "Amines, rosin",61790-47-4," In a key combined repeated dose, reproductive/developmental toxicity study, Gum Rosin was administered to rats (12/sex/dose) in dietary mixtures at concentrations of 0, 2500, 5000, and 10000 ppm for a period of 50 days for male rats and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum (at least 36 days, up to 53 days). The treatment with the test item did not lead to any premature mortalities and had no effects on behaviour, reflexes, grip strength, locomotor activity, and haematology parameters.  In the high dose group (10000 ppm), in both sexes, significantly lower food consumption was recorded during the first treatment week. From treatment week 2 until the end of the treatment period the food consumption was slightly decreased in males, but still significantly decreased in females when compared to the control group. The lower food consumption led to a transient lower body weight gain and lower body weights until the end of the study in both sexes. Except for ruffled fur in one female from the last day of gestation to the end of the lactation period, no clinical signs were observed. The water consumption was significantly reduced during the lactation period which was possibly due to the lower number of pups and therefore lower milk production in this group. Increased activity of alkaline phosphatase in males and increased bilirubin concentration in both sexes did not correlate with other findings and were therefore not considered adverse. Decreased absolute and relative thymus weights in females recorded at necropsy correlated with decreased lymphocytes in the cortex of the thymus. This finding was considered to be stress-related and likely not a direct effect of the test item. In the intermediate dose group (5000 ppm), lower food consumption was recorded in males and females during the first treatment week. From treatment week 2 onwards the food consumption was similar to the control group in males, but still decreased in females. The lower food consumption led to a transient lower body weight gain in males during the pre-paring period. However, decreased body weights compared to the concurrent controls were recorded during the entire treatment period in females. No clinical signs were observed at this dose level. The water consumption of females was slightly reduced during the lactation period. In the low dose group (2500 ppm), a transiently slightly lower body weight gain was recorded during the pre-pairing period in males. Afterwards the body weight development at this dose level was similar to the controls. The creatinine concentration was increased at all dose levels in males. An increase of creatinine is usually a sign for kidney damage. However, no histopathological findings were recorded in the kidneys. Therefore, the increase of the creatinine was not considered to be an adverse effect. Minimal hypertrophy/vacuolation of the zona glomerulosa was observed in the adrenal glands of males from the 2500 ppm group and in females from the 5000 ppm group with dose related-incidence. The pathogenesis of this change is uncertain. The zona glomerulosa is the site of synthesis of aldosterone which is mainly involved in the control of salt and water balance in the body. Secretion of aldosterone is controlled through the renin-angiotensin system and hypertrophy of the zona glomerulosa is generally considered to be an adaptative process following stimulation of this system. Therefore, this change was not considered to be an adverse effect. Based on the results of this study, a NOEL (No Observed Effect Level) for general toxicity could not be established due to effects on body weights at all dose levels in females during the lactation period. The NOAEL (No Observed Adverse Effect Level) for general toxicity was established at the dose level of 2500 ppm. For males, the lowest mean achieved dose level of 107.7 mg/kg/bw was derived at concertation 2500 ppm. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df6b129d-1d60-4b14-b7e6-6be7e2297e54/documents/2b8d29a0-d702-4b9c-96f5-62f5a5abdf95_44d40eae-43f4-428e-9dde-12354acabe27.html,,,,,, "Amines, rosin",61790-47-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df6b129d-1d60-4b14-b7e6-6be7e2297e54/documents/2b8d29a0-d702-4b9c-96f5-62f5a5abdf95_44d40eae-43f4-428e-9dde-12354acabe27.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,107.7 mg/kg bw/day,,rat "Amines, rosin",61790-47-4," Acute oral toxicity In one key acute oral toxicity study, Rosin amine 90 was administered in a single dose to female rats at one or more defined dosages. The toxicity of the test substance was assessed by stepwise treatment of groups of 3 females. At 2000 mg/kg, one animal was sacrificed for humane reasons on Day 8 (more than 20% body weight loss) and one animal was found dead on Day 10. At 300 mg/kg, no mortality occurred. The oral LD50 value of Rosin Amine 90 in Wistar rats was established to be within the range of 300- 2000 mg/kg body weight. the LD50 cut-off value was considered to be 2000 mg/kg body weight. Acute dermal toxicity In one key acute dermal toxicity study, Rosin amine 90 was administered to 5 female and 5 male Wistar rats via a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations, body weight was determined weekly and macroscopic examinations were performed on the day of death or after terminal sacrifice (Day 15). 2 animals were sacrificed for humane reasons, but no mortality due to systemic toxicity of Rosin Amine 90 was observed. Body weight gain was in the expected range and no abnormalities were seen in the macroscopic post-mortem examination of the animals. The dermal LD50 was determined to be more than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df6b129d-1d60-4b14-b7e6-6be7e2297e54/documents/cc415d2a-7eb9-4583-9f24-9c6797c3fe6f_44d40eae-43f4-428e-9dde-12354acabe27.html,,,,,, "Amines, rosin",61790-47-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df6b129d-1d60-4b14-b7e6-6be7e2297e54/documents/cc415d2a-7eb9-4583-9f24-9c6797c3fe6f_44d40eae-43f4-428e-9dde-12354acabe27.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "Amines, rosin",61790-47-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df6b129d-1d60-4b14-b7e6-6be7e2297e54/documents/cc415d2a-7eb9-4583-9f24-9c6797c3fe6f_44d40eae-43f4-428e-9dde-12354acabe27.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)",97862-65-2,The lowest acute oral LD50 obtained for the test item was found to be 526 mg/kg bw for male and female rats. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eee01bb3-c401-4304-9257-7d395f5e3e10/documents/IUC5-508a81b5-7505-4142-be20-ab7824f8c4c4_03481f54-4979-4bd1-a059-a8935f280798.html,,,,,, "Amines, rosin, compds. with 9-(2-carboxyphenyl)-3,6-bis(diethylamino)xanthylium chloride and disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]chromate(3-)",97862-65-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eee01bb3-c401-4304-9257-7d395f5e3e10/documents/IUC5-508a81b5-7505-4142-be20-ab7824f8c4c4_03481f54-4979-4bd1-a059-a8935f280798.html,,oral,LD50,526 mg/kg bw,adverse effect observed, "Amines, tallow alkyl, reaction products with hexamethylenediamine and TDI",1312943-49-9,"Acute oral toxicity studies were conducted with three TDI-I category members, Diurea 8, Tetraurea 2 and PU20. The results from these studies showed no evidence of acute toxicity up to the highest dose tested in any of the three studies (2000 mg/kg test item in arachis oil BP or corn oil). There is no evidence of a relevant intrinsic acute oral toxicity requiring classification or substance specific risk management measures. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): High ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f7bae72-039b-4549-b4a3-7554698370fc/documents/c0ea2639-73e3-452f-bc3c-6bd0b718b597_69c25dda-ecf3-47f0-a7f6-942c545dc445.html,,,,,, "Amines, tallow alkyl, reaction products with hexamethylenediamine and TDI",1312943-49-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f7bae72-039b-4549-b4a3-7554698370fc/documents/c0ea2639-73e3-452f-bc3c-6bd0b718b597_69c25dda-ecf3-47f0-a7f6-942c545dc445.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Amines, tri-C8-10-alkyl",68814-95-9,"Oral:Subacute Toxicity Study 28days, oral, rat, OECD 422, up to 400mg/kg bw/day tested: LOAEL >= 50mg/kg bw/d (BASF SE, 2013, 85R0674/12X380). Specific target organ toxicity: heart (cardiomyopathy) Dermal:No data availableInhalation:No data available ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da42f9f5-5b47-4e6e-8c1e-63d43bc41f3a/documents/c056669c-49bb-49fe-a7ff-0b079a62f8f7_57eba755-3773-4c12-9921-5357bf78033e.html,,,,,, "Amines, tri-C8-10-alkyl",68814-95-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da42f9f5-5b47-4e6e-8c1e-63d43bc41f3a/documents/c056669c-49bb-49fe-a7ff-0b079a62f8f7_57eba755-3773-4c12-9921-5357bf78033e.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,50 mg/kg bw/day,,rat "Amines, tri-C8-10-alkyl",68814-95-9,"Oral: - acute toxicity, oral, rat, Wistar, OECD 401 (limit test), Read across to CAS 1116-76-3: LD50>= (female/male) 2000 mg/kg bw, one death male and one death female Dermal:- acute toxicity, dermal, rat, Wistar, OECD 402, dermal discriminating dose-value (female/male) 5000mg/kg bw Inhalation:- No information on acute inhalation available for Amines, tri-C8-10-alkyl. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da42f9f5-5b47-4e6e-8c1e-63d43bc41f3a/documents/d22aa907-684e-4234-9eca-a3c3745f0f3a_57eba755-3773-4c12-9921-5357bf78033e.html,,,,,, "Amines, tri-C8-10-alkyl",68814-95-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da42f9f5-5b47-4e6e-8c1e-63d43bc41f3a/documents/d22aa907-684e-4234-9eca-a3c3745f0f3a_57eba755-3773-4c12-9921-5357bf78033e.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, "Amines, tri-C8-10-alkyl",68814-95-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da42f9f5-5b47-4e6e-8c1e-63d43bc41f3a/documents/d22aa907-684e-4234-9eca-a3c3745f0f3a_57eba755-3773-4c12-9921-5357bf78033e.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate",62037-80-3,Oral: NOAEL; OECD 453; Chronic Toxicity/Carcinogenicity ; NOAEL = 0.1 mg/kg bw/day. Reliability = 1 ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44e19448-3d8b-41cd-8d89-135229e77d95/documents/IUC5-a13ec9b0-f818-432d-bd68-fc97a170182c_b331058c-aa48-47a6-be86-8ec09c87aa50.html,,,,,, "Ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate",62037-80-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44e19448-3d8b-41cd-8d89-135229e77d95/documents/IUC5-a13ec9b0-f818-432d-bd68-fc97a170182c_b331058c-aa48-47a6-be86-8ec09c87aa50.html,Chronic toxicity – systemic effects,oral,NOAEL,0.1 mg/kg bw/day,,mouse "Ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate",62037-80-3,"Oral: OECD 425. LD50, rat. The LD50 was 1750 mg/kg. Reliability = 2 Dermal: OECD 402. LD50, rat. The LD50 was >5000 mg/kg. Reliability = 1Inhalation: OECD 403. 4-hr LC50, rat. The LC50 was >5200 mg/m3. Reliability =1. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44e19448-3d8b-41cd-8d89-135229e77d95/documents/IUC5-841c081e-0070-46a5-9ca0-0eda416ee2ad_b331058c-aa48-47a6-be86-8ec09c87aa50.html,,,,,, "Ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate",62037-80-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44e19448-3d8b-41cd-8d89-135229e77d95/documents/IUC5-841c081e-0070-46a5-9ca0-0eda416ee2ad_b331058c-aa48-47a6-be86-8ec09c87aa50.html,,oral,LD50,"1,750 mg/kg bw",adverse effect observed, "Ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate",62037-80-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44e19448-3d8b-41cd-8d89-135229e77d95/documents/IUC5-841c081e-0070-46a5-9ca0-0eda416ee2ad_b331058c-aa48-47a6-be86-8ec09c87aa50.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Ammonium 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propanoate",62037-80-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44e19448-3d8b-41cd-8d89-135229e77d95/documents/IUC5-841c081e-0070-46a5-9ca0-0eda416ee2ad_b331058c-aa48-47a6-be86-8ec09c87aa50.html,,inhalation,LC50,"5,200 mg/m3",no adverse effect observed, Ammonium 2-ethylhexyl sulphate,70495-37-3, In an acute oral toxicity study according to OECD Guideline 423 an LD50 of >2000 mg/kg bw was determined for the test item when administered as a single dose by oral gavage to female Sprague Dawley rats ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50e8f829-71bf-4e4d-a01f-aec8ec7d32cd/documents/f1b7b91e-6ea2-4865-83d7-7c8fbcac801c_07a4ccb4-598d-4e63-a5d3-f024c5b64451.html,,,,,, Ammonium formate,540-69-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Study conducted prior to implementation of OECD or GLP Guidelines, meets generally accepted scientific principles, acceptable for assessment ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/103c1d7d-2b37-4500-a2d7-e420e8d68e03/documents/c6eba03c-a449-4fa0-96e3-f5bbbefd60a9_cf2004d2-78fa-4688-9a58-0a375637b641.html,,,,,, Ammonium formate,540-69-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/103c1d7d-2b37-4500-a2d7-e420e8d68e03/documents/c6eba03c-a449-4fa0-96e3-f5bbbefd60a9_cf2004d2-78fa-4688-9a58-0a375637b641.html,,oral,LD50,"2,250 mg/kg bw",adverse effect observed, Ammonium hexafluorozirconate,16919-31-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The whole database is of good quality. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/625b237e-9fc7-4ab6-9fa2-553ce8ba1813/documents/67e99c52-d002-42e4-9419-a0687f57bdeb_2b0a0b77-875c-4f65-afa7-0589da3ceb9d.html,,,,,, Ammonium hexafluorozirconate,16919-31-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/625b237e-9fc7-4ab6-9fa2-553ce8ba1813/documents/67e99c52-d002-42e4-9419-a0687f57bdeb_2b0a0b77-875c-4f65-afa7-0589da3ceb9d.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Ammonium hydrogendifluoride,1341-49-7,"Comprehensive repeated dose oral toxicity data are available for sodium fluoride and for ammonia. AMBI will dissociate under physiological conditions to form fluoride and ammonium ions. The effects of repeated exposure to AMBI at high concentrations will be dominated by local corrosivity and irritation. Ammonium is of relatively low sytemic toxicity, therefore the critical systemic toxic effects of AMBI will be due to fluoride. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2920ee75-ae24-49ce-a34d-58056cd6cfec/documents/IUC5-39ae84f3-1668-46d9-97fc-9a71f98309ab_f4957bf9-5bc7-4cf9-866a-91f4588df2c9.html,,,,,, Ammonium hydrogendifluoride,1341-49-7,"The acute oral LD50 of the substance in the rat is reported to be 130 mg/kg bw (Musch & Hoffer, 1990); no data are available for acute dermal or inhalation toxicity however waiver are appropriate for these endpoints due to the corrosive nature of the substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2920ee75-ae24-49ce-a34d-58056cd6cfec/documents/IUC5-f1efc757-430b-4ce2-9f21-843b350b9452_f4957bf9-5bc7-4cf9-866a-91f4588df2c9.html,,,,,, Ammonium hydrogendifluoride,1341-49-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2920ee75-ae24-49ce-a34d-58056cd6cfec/documents/IUC5-f1efc757-430b-4ce2-9f21-843b350b9452_f4957bf9-5bc7-4cf9-866a-91f4588df2c9.html,,oral,LD50,130 mg/kg bw,, Ammonium iron bis(sulphate),10138-04-2," Since ammonium iron bis(sulphate) dissociates upon dissolution in aqueous media, the toxicity of this substance can be assessed by regarding the toxicity of ions formed. In studies regarding the acute oral toxicity of ammonium sulfate, ferric chloride and ferric ammonium citrate LD50 values between 1300 mg/kg bw and 5000 mg/kg bw were found. All the reported values correspond to doses of ammonium iron bis(sulphate) > 2000 mg/kg bw (2093 - 15400 mg/kg bw). Therefore, ammonium iron bis(sulphate) is not classified.  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dfc7599-5100-4a9c-8950-798377344fd8/documents/1ad960a7-3532-4675-8e7a-6711b4255849_4e5865a4-cd89-4fa1-809c-1aaa54ff8ca1.html,,,,,, Ammonium iron bis(sulphate),10138-04-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dfc7599-5100-4a9c-8950-798377344fd8/documents/1ad960a7-3532-4675-8e7a-6711b4255849_4e5865a4-cd89-4fa1-809c-1aaa54ff8ca1.html,,oral,LD50,"2,093 mg/kg bw",no adverse effect observed, Ammonium iron(III) trimethylenediaminetetraacetate hemihydrate,111687-36-6,Data are available from a 28-day oral toxicity study and limited information is available from a 90-day oral toxicity study. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a9bd269-1440-49d8-b46c-6d9fe5a01e81/documents/IUC5-a70a1037-3c43-45e1-b4fa-766f8c1843d9_7c120b5a-4a1a-46a0-83dd-e532c5c6f3f2.html,,,,,, Ammonium iron(III) trimethylenediaminetetraacetate hemihydrate,111687-36-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a9bd269-1440-49d8-b46c-6d9fe5a01e81/documents/IUC5-a70a1037-3c43-45e1-b4fa-766f8c1843d9_7c120b5a-4a1a-46a0-83dd-e532c5c6f3f2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Ammonium iron(III) trimethylenediaminetetraacetate hemihydrate,111687-36-6,Two acute oral and one acute dermal toxicity study were available. Both routes showed LD50 values of at least > 2000 mg/kg bw. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a9bd269-1440-49d8-b46c-6d9fe5a01e81/documents/IUC5-bfbcf2b0-a4ad-43cd-a36f-f0ebbf2d23ff_7c120b5a-4a1a-46a0-83dd-e532c5c6f3f2.html,,,,,, Ammonium molybdate(VI),13106-76-8," Acute oral toxicity: Acute oral toxicity test was performed from Dictionary of Environmentally Important Chemicals, 1999 in rats at 333 mg/kg dose concentration After treatment it was considered that the LD 50 value for ammonium molybdate (13106-76-8) was considered to be 333 mg/kg in rats. Acute dermal toxicity: ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3f339f7-5620-479b-ba3b-13cd7098e5c1/documents/a5bb01ed-0945-423a-8f72-a8eec806d52c_90cf1d2e-d8ac-4666-84ac-85bd0714188d.html,,,,,, Ammonium molybdate(VI),13106-76-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3f339f7-5620-479b-ba3b-13cd7098e5c1/documents/a5bb01ed-0945-423a-8f72-a8eec806d52c_90cf1d2e-d8ac-4666-84ac-85bd0714188d.html,,oral,LD50,333 mg/kg bw,adverse effect observed, Ammonium perchlorate,7790-98-9,"Ammonium perchlorate was shown to have antithyroid effects, without any other repeat-dose toxic effects, in a Klimisch 2 GLP rat 90-day study at up to 10 mg/kg/day via drinking water. The overall NOAEL was 1 mg/kg/day. All antithyroid effects were demonstrated to be partly to completely reversible within 30 days.However, the antithyroid effects from a rat 2-generation study were considered to be more reliable for the classification related to repeated exposure, because of this study's higher sensitivity than the 90-day study (40% longer treatment duration: 113-142 days, more individual thyroid data per sex per dose: 56-60 vs. 9-10, 3-fold higher top-dose, presence of highly sensitive populations: pregnant dams and pups) and of the better biological relevance of the dose-relationship (dose-increase, vs. plateauing of effects in the 90-day study). This resulted in a lower NOAEL of 0.3 mg/kg/day.Two occupational studies were retained as being the key data sources for risk assessment purposes, based on several quality criteria and also the fact that they involved relatively high exposure levels for chronic exposures: Lamm 1999 and Braverman 2005, both leading to similar repeat-dose toxicity systemic (biomonitoring-based) NOAELs of 0.21 and 0.20 mg Ammonium Perchlorate/kg/day for chronic exposure. These data were retained as the most relevant as they avoid inter-species extrapolations, which are considered difficult and full of uncertainty due to the important inter-species differences in physiology of the thyroid regulation and therefore in sensitivity to antithyroid compounds. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca9cf909-984b-49b6-b596-4f3af1e102dd/documents/IUC5-c8b4cd18-bfac-4ac5-b3f4-57ef531a15ac_6c95a5f1-0183-4354-90c0-d12ae4dd331a.html,,,,,, Ammonium perchlorate,7790-98-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca9cf909-984b-49b6-b596-4f3af1e102dd/documents/IUC5-c8b4cd18-bfac-4ac5-b3f4-57ef531a15ac_6c95a5f1-0183-4354-90c0-d12ae4dd331a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.3 mg/kg bw/day,,rat Ammonium perchlorate,7790-98-9,"Oral, Dermal:ANHYDROUS SODIUM PERCHLORATE was administered orally and dermally to rats according to OECD Guidelines 423 and 402 respectively. The LD0 of ANHYDROUS SODIUM PERCHLORATE was found to be higher than 2000 mg/kg when administered via the oral or dermal route.A read-across is provided in section 13 to support the transposition from sodium perchlorate to ammonium perchlorate.Inhalation:Due to the explosivity of finest Ammonium Perchlorate granulometries, it is impossible to carry out the test for safety (testing team and facilities) and ethical (test animals) reasons. The study is not required since reliable acute oral and dermal toxicity data are available (thanks to a read-across). Last, the study is also scientifically useless since there is no reason to suspect that effects upon inhalation could be more important or different than by oral route: oral absorption is itself quick and total, and there is no metabolism for this rather simple ion (both: see 711). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca9cf909-984b-49b6-b596-4f3af1e102dd/documents/IUC5-60350394-ab9b-4b2c-8b62-1ccea6bb303b_6c95a5f1-0183-4354-90c0-d12ae4dd331a.html,,,,,, Ammonium perchlorate,7790-98-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca9cf909-984b-49b6-b596-4f3af1e102dd/documents/IUC5-60350394-ab9b-4b2c-8b62-1ccea6bb303b_6c95a5f1-0183-4354-90c0-d12ae4dd331a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ammonium perchlorate,7790-98-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca9cf909-984b-49b6-b596-4f3af1e102dd/documents/IUC5-60350394-ab9b-4b2c-8b62-1ccea6bb303b_6c95a5f1-0183-4354-90c0-d12ae4dd331a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ammonium perrhenate,13598-65-7,"In a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening (OECD TG422) with ammonium perrhenate, treatment of rats by gavage at 330 mg/kg bw/day was associated with an increase in thyroid weight in both sexes. A slight increased incidence of ploughing and excess salivation was also noted in males at this dose level. Treatment at 110 mg/kg bw/day revealed no significant changes in any of the parameters assessed that were considered to be indicative of a reaction to treatment. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b52b0bd4-32d1-43c7-a2b6-5a5deda67f27/documents/IUC5-959cb3ad-b41b-4b66-9be4-fb8cbad8dd4e_78b5c049-d2f0-456a-8b64-cb73a3090931.html,,,,,, Ammonium perrhenate,13598-65-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b52b0bd4-32d1-43c7-a2b6-5a5deda67f27/documents/IUC5-959cb3ad-b41b-4b66-9be4-fb8cbad8dd4e_78b5c049-d2f0-456a-8b64-cb73a3090931.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,110 mg/kg bw/day,,rat Ammonium perrhenate,13598-65-7,A (limited) acute oral toxicity study determined an LD50 as >2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b52b0bd4-32d1-43c7-a2b6-5a5deda67f27/documents/IUC5-57dc64b2-b97f-4749-b360-3f91721586a6_78b5c049-d2f0-456a-8b64-cb73a3090931.html,,,,,, Ammonium perrhenate,13598-65-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b52b0bd4-32d1-43c7-a2b6-5a5deda67f27/documents/IUC5-57dc64b2-b97f-4749-b360-3f91721586a6_78b5c049-d2f0-456a-8b64-cb73a3090931.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Ammonium phosphinate,7803-65-8," Acute oral toxicity: The acute oral median lethal dose (LD50) for the test chemical using rats was determined to be 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Ammonium phosphinate (CAS no.: 7803-65-8) cannot be classified for acute oral toxicity and is classified as ""Not classified"" ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/849c3e1c-1938-4703-8cbc-25a097b07927/documents/4017e777-c656-402e-a01b-fc082d57762d_24bf3966-bae2-46f8-a78f-6499cceb23d7.html,,,,,, Ammonium phosphinate,7803-65-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/849c3e1c-1938-4703-8cbc-25a097b07927/documents/4017e777-c656-402e-a01b-fc082d57762d_24bf3966-bae2-46f8-a78f-6499cceb23d7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ammonium sodium 2-[4-[[1-[[(2-methoxy-5-methyl-4-sulphonatophenyl)amino]carbonyl]-2-oxopropyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonate,72705-24-9, In a combined repeated dose oral gavage toxicity study with the reproduction/developmental toxicity screening with the test item the No-Observed-Adverse-Effect Level (NOAEL) for general toxicity was considered to be 1000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9f21b53-f9f2-4320-9cbd-a29f8c2f773d/documents/23d73346-57f6-4159-9175-bf7be0467207_de73262b-c100-407f-988a-05f14f56518a.html,,,,,, Ammonium sodium 2-[4-[[1-[[(2-methoxy-5-methyl-4-sulphonatophenyl)amino]carbonyl]-2-oxopropyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonate,72705-24-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9f21b53-f9f2-4320-9cbd-a29f8c2f773d/documents/23d73346-57f6-4159-9175-bf7be0467207_de73262b-c100-407f-988a-05f14f56518a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Ammonium sodium 2-[4-[[1-[[(2-methoxy-5-methyl-4-sulphonatophenyl)amino]carbonyl]-2-oxopropyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonate,72705-24-9, Acute oral toxicity The acute oral LD50 was determined to be > 2000 mg/kg bw. Acute dermal toxicity The acute dermal LD50 was determined to be > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9f21b53-f9f2-4320-9cbd-a29f8c2f773d/documents/938512fe-7adb-43a5-ba6c-90cd86f1ff0a_de73262b-c100-407f-988a-05f14f56518a.html,,,,,, Ammonium sodium 2-[4-[[1-[[(2-methoxy-5-methyl-4-sulphonatophenyl)amino]carbonyl]-2-oxopropyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonate,72705-24-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9f21b53-f9f2-4320-9cbd-a29f8c2f773d/documents/938512fe-7adb-43a5-ba6c-90cd86f1ff0a_de73262b-c100-407f-988a-05f14f56518a.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Ammonium sodium 2-[4-[[1-[[(2-methoxy-5-methyl-4-sulphonatophenyl)amino]carbonyl]-2-oxopropyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonate,72705-24-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9f21b53-f9f2-4320-9cbd-a29f8c2f773d/documents/938512fe-7adb-43a5-ba6c-90cd86f1ff0a_de73262b-c100-407f-988a-05f14f56518a.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Ammonium sodium vanadium oxide,39455-80-6,"Studies via the oral and inhalation route are not available for ammonium sodium vanadium oxide, but for other vanadium substances. Of the limited effects noted following oral exposure of soluble vanadium substances, it appears most likely that effects on hematological parameters are the most consistently reported among a number of investigators.Information on repeated dose toxicity following inhalation exposure to V2O5 is available in a NTP study (k_NTP 2002) with exposure of male and female rats and mice to V2O5 over 16-days, 3-months and 2-years. Pulmonary reactivity to vanadium pentoxide was also investigated following subchronic inhalation exposure in a non-human primate animal model. The rationale for read-across to ammonium sodium vanadium oxide is summarised below (see discussion). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a286700f-812e-47e3-b4ad-bee92d424854/documents/IUC5-b9569643-f695-4bec-9c10-a6a8b1f54860_c9f34cc0-4ace-4585-8469-1f6acbc9c802.html,,,,,, Ammonium sodium vanadium oxide,39455-80-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a286700f-812e-47e3-b4ad-bee92d424854/documents/IUC5-b9569643-f695-4bec-9c10-a6a8b1f54860_c9f34cc0-4ace-4585-8469-1f6acbc9c802.html,Chronic toxicity – systemic effects,oral,LOAEL,5.92 mg/kg bw/day,,rat Ammonium sodium vanadium oxide,39455-80-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a286700f-812e-47e3-b4ad-bee92d424854/documents/IUC5-b9569643-f695-4bec-9c10-a6a8b1f54860_c9f34cc0-4ace-4585-8469-1f6acbc9c802.html,Repeated dose toxicity – local effects,inhalation,LOAEC,0.55 mg/m3,adverse effect observed,rat Ammonium sodium vanadium oxide,39455-80-6,"Key studies demonstrate acute toxicity via the oral and inhalation route, however not via the dermal route: Data are read-across from structural analogues, i.e. sodium trivanadium octaoxide and ammonium trivanadium octaoxide, based on inertness and similar solubility or lack thereof.Two reliable studies by Wolf (2006a,b) were conducted with sodium trivanadium octaoxide and ammonium trivanadium octaoxide. The LD50 was determined to be 500 mg/kg bw for sodium trivanadium octaoxide and 200 mg/kg bw for ammonium trivanadium octaoxide. Using a worst case scenerio approach, the LD50 of 200 mg/kg bw will finally be used to cover this endpoint. Two reliable studies by Weniger (2006a,b) were conducted with sodium trivanadium octaoxide and ammonium trivanadium octaoxide. The LC50 (male are the sensitive species) was determined to be 1.18 mg/L air (analytical) for sodium trivanadium octaoxide and 0.67 mg/L air for ammonium trivanadium octaoxide. Using a worst case scenerio approach, the LC50 of 0.67 mg/L air will finally be used to cover this endpoint. Two reliable studies by Bernat (2006a,b) were conducted with sodium trivanadium octaoxide and ammonium trivanadium octaoxide. The LD50 was determined to be greater than 2000 mg/kg bw for both vanadium compounds. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a286700f-812e-47e3-b4ad-bee92d424854/documents/IUC5-571d9fa8-f9e8-459b-bf00-9090c7c45309_c9f34cc0-4ace-4585-8469-1f6acbc9c802.html,,,,,, Ammonium sodium vanadium oxide,39455-80-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a286700f-812e-47e3-b4ad-bee92d424854/documents/IUC5-571d9fa8-f9e8-459b-bf00-9090c7c45309_c9f34cc0-4ace-4585-8469-1f6acbc9c802.html,,oral,LD50,200 mg/kg bw,adverse effect observed, Ammonium sodium vanadium oxide,39455-80-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a286700f-812e-47e3-b4ad-bee92d424854/documents/IUC5-571d9fa8-f9e8-459b-bf00-9090c7c45309_c9f34cc0-4ace-4585-8469-1f6acbc9c802.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Ammonium sodium vanadium oxide,39455-80-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a286700f-812e-47e3-b4ad-bee92d424854/documents/IUC5-571d9fa8-f9e8-459b-bf00-9090c7c45309_c9f34cc0-4ace-4585-8469-1f6acbc9c802.html,,inhalation,LC50,670 mg/m3,adverse effect observed, Ammonium thiosulphate,7783-18-8,"A 3-generation chronic toxicity study (Til et al. 1972a) with treatment of rats (20 per sex and group) with dose levels of 0, 0.125, 0.25, 0.5, 1.0 or 2.0% Na2S2O5 administered in a 50 ppm thiamine-containing diet was identified as most reliable study for repeated dose toxicity and was defined as key study (read-across info, see `discussion`). Based on the read across concept for the group of sulfite and thiosulfate substances, this result is also applicable to ammonium thiosulfate. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1909e803-c4ef-47f1-9976-ff65acfcfa79/documents/IUC5-3963d81c-b310-445c-808b-ab5b3604abd8_3d750282-4cdd-4e89-8a40-5aff5aa0f3a9.html,,,,,, Ammonium thiosulphate,7783-18-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1909e803-c4ef-47f1-9976-ff65acfcfa79/documents/IUC5-3963d81c-b310-445c-808b-ab5b3604abd8_3d750282-4cdd-4e89-8a40-5aff5aa0f3a9.html,Chronic toxicity – systemic effects,oral,NOAEL,168 mg/kg bw/day,,rat Ammonium thiosulphate,7783-18-8,"Acute toxicity values (oral, dermal and inhalation) were determined for ammonium thiosulfate utilising substance specific data as well as read-across to sodium sulfite (CAS 7757-83-7), potassium thiosulfate (CAS 10294-66-3) and calcium thiosulfate (10124-41-1).Please see discussion below. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1909e803-c4ef-47f1-9976-ff65acfcfa79/documents/IUC5-0b5e8cba-7c5c-4d44-a361-da1984df3ef3_3d750282-4cdd-4e89-8a40-5aff5aa0f3a9.html,,,,,, Ammonium trivanadium octaoxide,12207-63-5,"Description of key information - soluble vanadium substances group (oral) A comprehensive literature search was recently conducted for the vanadium category substances, to source relevant information for the hazard and risk assessment. For the group of the soluble vanadium substances, a limited number of studies is available, and the different experimental approaches lead to a variety of endpoints measured. Of the limited effects noted following oral exposure with soluble vanadium substances, it appears most likely that effects on haematological parameters are the most consistently reported among a number of investigators (Mountain et al 1953, Zaporowska et al. 1993, Scibior et al 2006, Scibior, 2005, NTP, 2002, NTP, 2023). Altogether, haematological effects have been found with a variety of different vanadium compounds including sodium metavanadate, vanadium pentoxide, and ammonium metavanadate supporting the use of this endpoint for risk assessment purposes. Furthermore, epithelial hyperplasia in the small intestine of rats and mice were observed after the administration of sodium metavanadate and vanadyl sulfate (NTP, 2023). Therefore, this endpoint should also be considered for risk assessment purposes. Information on repeated dose toxicity following inhalation exposure to divanadium pentaoxide is available in a NTP study (k_NTP 2002) with exposure of male and female rats and mice to V2O5 over 16-days, 3-months and 2-years. Pulmonary reactivity to divanadium pentaoxide was also investigated following subchronic inhalation exposure in a non-human primate animal model. Data of the repeated-dose toxicity via the dermal route are not available for any vanadium substance. Following the HERAG guidance for metals and metal salts (see section 7.1.2 of the technical dossier: dermal absorption), negligible percutaneous uptake based on minimal penetration, i.e. a dermal absorption rate in the range of maximally 0.1 - 1.0 %, can be anticipated. Dermal absorption in this order of magnitude is not considered to be “significant”. Thus, regarding repeated-dose toxicity of vanadium substances, the dermal exposure route is not expected to be the most relevant. EBRC (2007) HERAG fact sheet - Assessment of occupational dermal exposure and dermal absorption for metals and inorganic metal compounds, EBRC Consulting GmbH, Hannover, Germany, August 2007, 49 pages.   Further information: Divanadium pentaoxide has been excluded from the soluble vanadium substances read-across group due to its legal classification. Thus, studies conducted with divanadium pentaoxide are reported for information purposes only. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7803676-ef9b-457d-a96b-5b9025bdb8ff/documents/IUC5-c9b60ef5-5edf-407a-82d5-9a9cebb87bf0_aeb6e912-1e67-4642-8d7d-c333f1b7fcde.html,,,,,, Ammonium trivanadium octaoxide,12207-63-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7803676-ef9b-457d-a96b-5b9025bdb8ff/documents/IUC5-c9b60ef5-5edf-407a-82d5-9a9cebb87bf0_aeb6e912-1e67-4642-8d7d-c333f1b7fcde.html,Repeated dose toxicity – local effects,inhalation,LOAEC,0.55 mg/m3,adverse effect observed,rat Ammonium trivanadium octaoxide,12207-63-5," Acute oral toxicity: LD50 = 200 mg/kg bw (OECD 423; GLP; female rats) Acute inhalation toxicity: LC50 = 0.67 mg/L air (analytical) (OECD 403; GLP, male rats) Acute dermal toxicity: LD50 > 2000 mg/kg bw (OECD 402; GLP) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7803676-ef9b-457d-a96b-5b9025bdb8ff/documents/IUC5-88b8d609-d122-4f0f-8086-008ba073720e_aeb6e912-1e67-4642-8d7d-c333f1b7fcde.html,,,,,, Ammonium trivanadium octaoxide,12207-63-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7803676-ef9b-457d-a96b-5b9025bdb8ff/documents/IUC5-88b8d609-d122-4f0f-8086-008ba073720e_aeb6e912-1e67-4642-8d7d-c333f1b7fcde.html,,oral,LD50,200 mg/kg bw,adverse effect observed, Ammonium trivanadium octaoxide,12207-63-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7803676-ef9b-457d-a96b-5b9025bdb8ff/documents/IUC5-88b8d609-d122-4f0f-8086-008ba073720e_aeb6e912-1e67-4642-8d7d-c333f1b7fcde.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Ammonium trivanadium octaoxide,12207-63-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7803676-ef9b-457d-a96b-5b9025bdb8ff/documents/IUC5-88b8d609-d122-4f0f-8086-008ba073720e_aeb6e912-1e67-4642-8d7d-c333f1b7fcde.html,,inhalation,LC50,670 mg/m3,adverse effect observed, Ammonium undecafluorohexanoate,21615-47-4," Oral (OECD 408), rat: NOAEL (local) = 20 mg/kg bw/day Read-across from structural analogue source substance sodium undecafluorohexanoate (CAS 2923-26-4) Oral (OECD 453, combined chronic toxicity/carcinogenicity, read-across), rat: NOAEL systemic (males) = 15 mg/kg bw/day and NOAEL systemic (females) = 30 mg/kg bw/day Read-across from structural analogue source substance undecafluorohexanoic acid (CAS 307-24-4). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10954894-444a-449e-ae6b-66bf6f57acdb/documents/6651cf39-5a38-4935-acf5-d8f2363eac65_68abeb84-46d5-410b-98d3-0d0322ca72d4.html,,,,,, Ammonium undecafluorohexanoate,21615-47-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10954894-444a-449e-ae6b-66bf6f57acdb/documents/6651cf39-5a38-4935-acf5-d8f2363eac65_68abeb84-46d5-410b-98d3-0d0322ca72d4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat Ammonium undecafluorohexanoate,21615-47-4," Oral (OECD 420), rat: LD50 > 300 mg/kg bw < 2000 mg/kg bw Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10954894-444a-449e-ae6b-66bf6f57acdb/documents/d4bbc708-3173-423b-b519-f5e9f311661d_68abeb84-46d5-410b-98d3-0d0322ca72d4.html,,,,,, Ammonium undecafluorohexanoate,21615-47-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10954894-444a-449e-ae6b-66bf6f57acdb/documents/d4bbc708-3173-423b-b519-f5e9f311661d_68abeb84-46d5-410b-98d3-0d0322ca72d4.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Ammonium undecafluorohexanoate,21615-47-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10954894-444a-449e-ae6b-66bf6f57acdb/documents/d4bbc708-3173-423b-b519-f5e9f311661d_68abeb84-46d5-410b-98d3-0d0322ca72d4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ammonium wolframate,11120-25-5," Repeated Dose Toxicity - Oral Route: No oral repated dose toxicity data of sufficient quality were available specifically on ammonium paratungstate (target substance). However, oral repeated dose toxicity data is available on sodium tungstate (source substance), which are used for read-across. Due to similar water solubility and lower toxicity for the target substance compared to the source substance, the resulting read-across from the source substance to the target substance is appropriate as a conservative estimate of potential toxicity for this endpoint. In addition, read-across is appropriate because the classification and labelling is more protective for the source substance than the target substance, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, conservative for the target substance. For more details, refer to the read-across category approach in the Category section of this IUCLID submission or Annex 3 in the CSR. The read across study on sodium tungstate was sponsored conducted the United States Army Center for Health Promotion and Preventive Medicine and published byMcCain et al (2015). The 90-day oral toxicity study was conducted in rats according to the procedure described in the Environmental Protection Agency (EPA) Health Effects Testing Guidelines (40 CFR, Part 798.2650) in compliance with Good Laboratory Practice. Briefly, this study of the subchronic toxicity of sodium tungstate dihydrate aqueous solution in male and female Sprague-Dawley rats was evaluated by daily oral gavage of 0, 10, 75, 125, or 200 mg/kg bw/d for 90 days. Measured parameters included food consumption, body weight measurements, hematology, clinical chemistry, and histopathological changes. There was a significant decrease in food consumption and body weight gain in males at 200 mg/kg bw/d from days 77 to 90; however, there was no effect in food consumption and body weights in females. There were no changes in the hematological and clinical parameters studied. Histopathological changes were seen in kidney of male and female and epididymis of male rats. The histopathological changes observed in the kidneys of male and female rats dosed at 125 or 200 mg/k/d consisting of mild to severe cortical tubule basophilia in 2 high-dose groups. Histological changes in epididymides included intraluminal hypospermia with cell debris in the 200 mg/kg bw/day dosed male rats. Histopathological changes were observed in the glandular stomach including inflammation and metaplasia in the high-dose groups (125 or 200 mg/kg bw/day) of both sexes of rats. Based on histopathology effects seen in the kidneys, the lowest observable adverse effect level was 125 mg/kg bw/d and the no observable adverse effect level was 75 mg/kg bw/d in both sexes of rats for oral subchronic toxicity. The USEPA’s Benchmark Dose Software (BMDS, Version 1.4.1) was used to model the data to derive a BMDL10. The lowest (most precautionary) BMDL10 from the renal toxicity endpoint in the 90-day oral toxicity study was 102 mg/kg bw/d. In addition to McCain et al (2015) rat oral 90-day repeated dose study, the US National Toxicology Program (NTP) has conducted two additional 90-day drinking water studies, one in Sprague-Dawley rats and a second one in B6C3F1 mice (10/sex/species/dose). The study design included doses of0, 125, 250, 500, 1000 or 2000 mg/L. The in-life study phase has been completed but no study report has yet been issued. Currently, available in the US NTP website are graphs and Tables are preliminary results, but no full report has been issued. Furthermore, at the 2012 Annual Meeting of the Society of Toxicology, a Scientific Poster was presented detailing preliminary results of the NTP study. Preliminary results confirm the results of the McCain gavage study, showing the kidney as the major target organ for tungstate (especially at high drinking water doses of 1,000 and 2,000 mg/L). The US NTP’s final reports of sodium tungstate would be available in 2022. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ddecd1de-114c-44ef-b64c-e3c6cbf923b8/documents/f35587dc-8997-4657-b923-526e3098845b_f8332bbb-872d-4a0e-b8fb-9d49db98bd4e.html,,,,,, Ammonium wolframate,11120-25-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ddecd1de-114c-44ef-b64c-e3c6cbf923b8/documents/f35587dc-8997-4657-b923-526e3098845b_f8332bbb-872d-4a0e-b8fb-9d49db98bd4e.html,Sub-chronic toxicity – systemic effects,oral,BMDL10,102 mg/kg bw/day,,rat Ammonium wolframate,11120-25-5," In an acute oral toxicity study conducted on rats and according to OECD 401, the LD50 was reported to be >2000 mg/kg. In an acute inhalation toxicity study conducted on rats, the 4hr-LC50 was reported to be >5.35 mg/L (5,350 mg/m3). In an acute dermal toxicity study conducted on rats and according to OECD 402, the LD50 was reported to be >2,000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ddecd1de-114c-44ef-b64c-e3c6cbf923b8/documents/IUC5-160ae7cd-b52e-4eaa-a3b9-b5e05ddbc41d_f8332bbb-872d-4a0e-b8fb-9d49db98bd4e.html,,,,,, Ammonium wolframate,11120-25-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ddecd1de-114c-44ef-b64c-e3c6cbf923b8/documents/IUC5-160ae7cd-b52e-4eaa-a3b9-b5e05ddbc41d_f8332bbb-872d-4a0e-b8fb-9d49db98bd4e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ammonium wolframate,11120-25-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ddecd1de-114c-44ef-b64c-e3c6cbf923b8/documents/IUC5-160ae7cd-b52e-4eaa-a3b9-b5e05ddbc41d_f8332bbb-872d-4a0e-b8fb-9d49db98bd4e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ammonium wolframate,11120-25-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ddecd1de-114c-44ef-b64c-e3c6cbf923b8/documents/IUC5-160ae7cd-b52e-4eaa-a3b9-b5e05ddbc41d_f8332bbb-872d-4a0e-b8fb-9d49db98bd4e.html,,inhalation,LC50,"5,350 mg/m3",no adverse effect observed, Ammonium zinc chloride,52628-25-8,"Non-human informationNH4ClThe NOEL for NH4Cl was determined to be 684 mg/kg bw day. Zn:The repeated dose toxicity of water soluble zinc sulphate and zinc monoglycerolate has been examined in a total of 3 subchronic oral feeding studies. Due to the different dosing regimens, the lowest NOAEL was determined to be 31.5 mg/kg bw/day of zinc monoglycerolate which equals a total zinc exposure of approximate 13 mg/kg bw/day. The zinc NOAEL derived from the feeding studies with zinc sulphate was determined to be 104 mg Zn/kg bw/day in mice and approximately 53.5 mg/kg bw/day in rats. At higher doses the most important effects in the rats were the development of hypocupremia, and significant changes in the pancreas (i.e., focal acinar degeneration and necrosis) and a decreased number of pigmented macrophages in spleen.So Zn is responsible for toxicity.No dermal and inhalation test provided in due the test material is corrosive. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/700e78e3-8316-4112-ae2c-e38d910d09d0/documents/IUC5-c365556f-75da-4b55-b44c-ab6746c63a59_8bd6d224-92b3-42af-aa56-c47df7d42748.html,,,,,, Ammonium zinc chloride,52628-25-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/700e78e3-8316-4112-ae2c-e38d910d09d0/documents/IUC5-c365556f-75da-4b55-b44c-ab6746c63a59_8bd6d224-92b3-42af-aa56-c47df7d42748.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,2.7 mg/m3,,guinea pig Ammonium zinc chloride,52628-25-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/700e78e3-8316-4112-ae2c-e38d910d09d0/documents/IUC5-c365556f-75da-4b55-b44c-ab6746c63a59_8bd6d224-92b3-42af-aa56-c47df7d42748.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,13.3 mg/kg bw/day,,rat Amoxicillin,26787-78-0,Key study: Test method OECD 422. GLP study. The NOAEL for the subacute repeated dose toxicity of amoxicillin trihydrate in rats by oral route was determined to equal or higher than 2450 mg/kg bw/day since no adverse effects were observed at the highest dose tested. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac18ed2d-3427-4b42-86e1-2c536446f34a/documents/IUC5-88f275f0-2f84-4e09-9884-a11418c91789_4c0460f1-fa32-4dda-b5d9-6399805f1f06.html,,,,,, Amoxicillin,26787-78-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac18ed2d-3427-4b42-86e1-2c536446f34a/documents/IUC5-88f275f0-2f84-4e09-9884-a11418c91789_4c0460f1-fa32-4dda-b5d9-6399805f1f06.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"2,450 mg/kg bw/day",,rat Amoxicillin,26787-78-0,Acute oral toxicity: Key study. Test method OECD 423. GLP study. The oral LD50 in rats was determined to be > 2000 mg/kg bw.Acute dermal toxicity: Key study: Test method OECD 402. GLP study. The dermal LD50 in rats was determined to be > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac18ed2d-3427-4b42-86e1-2c536446f34a/documents/IUC5-a9ed28ae-85f6-4ba1-9cd4-f152b9e5ba04_4c0460f1-fa32-4dda-b5d9-6399805f1f06.html,,,,,, Amoxicillin,26787-78-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac18ed2d-3427-4b42-86e1-2c536446f34a/documents/IUC5-a9ed28ae-85f6-4ba1-9cd4-f152b9e5ba04_4c0460f1-fa32-4dda-b5d9-6399805f1f06.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Amoxicillin,26787-78-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac18ed2d-3427-4b42-86e1-2c536446f34a/documents/IUC5-a9ed28ae-85f6-4ba1-9cd4-f152b9e5ba04_4c0460f1-fa32-4dda-b5d9-6399805f1f06.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "amporphous glass fibre formed from the melting and fiberisation of predominately slilcon dioxide, calcium oxide, magnesium oxide",436083-99-7,"Most repeated dose studies carried out have used inhalation, this is the most relevant route of exposure due to the fibrous nature of the material, no unusual ill effects were reported in any of the studies. A reproductive toxicity screening study (OECD 421) was carried out using this material administered orally, again no toxic effects were seen. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ecd8dba5-c826-4d8b-b656-3803b0f1e5d6/documents/IUC5-bb07d0f5-2410-406e-9955-c06563fcb69c_25be731f-dc61-4daf-9b76-4293407d398d.html,,,,,, "amporphous glass fibre formed from the melting and fiberisation of predominately slilcon dioxide, calcium oxide, magnesium oxide",436083-99-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ecd8dba5-c826-4d8b-b656-3803b0f1e5d6/documents/IUC5-bb07d0f5-2410-406e-9955-c06563fcb69c_25be731f-dc61-4daf-9b76-4293407d398d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "amporphous glass fibre formed from the melting and fiberisation of predominately slilcon dioxide, calcium oxide, magnesium oxide",436083-99-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ecd8dba5-c826-4d8b-b656-3803b0f1e5d6/documents/IUC5-bb07d0f5-2410-406e-9955-c06563fcb69c_25be731f-dc61-4daf-9b76-4293407d398d.html,Chronic toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat "amporphous glass fibre formed from the melting and fiberisation of predominately slilcon dioxide, calcium oxide, magnesium oxide",436083-99-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ecd8dba5-c826-4d8b-b656-3803b0f1e5d6/documents/IUC5-bb07d0f5-2410-406e-9955-c06563fcb69c_25be731f-dc61-4daf-9b76-4293407d398d.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat "amporphous glass fibre formed from the melting and fiberisation of predominately slilcon dioxide, calcium oxide, magnesium oxide",436083-99-7,No mineral fibres including this substance have shown acute toxic effects ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecd8dba5-c826-4d8b-b656-3803b0f1e5d6/documents/IUC5-02893b8f-8577-4d23-be8f-9bed2b4e2988_25be731f-dc61-4daf-9b76-4293407d398d.html,,,,,, "Amylase, α-",9000-90-2,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyInformation.KeyInformation): Repeated dose oral and dermal toxicity of alpha-amylase has been tested, while the repeated dose inhalation toxicity was waived. Repeated dose oral toxicity study was a subchronic toxicity test conducted according to OECD guideline 408 (adopted 1998), and in compliance with GLP.  The conclusion was that the No Observed Adverse Effect Level (NOAEL) in rats was the highest dose level tested, equivalent to 10 mL of the undiluted alpha-amylase batch/kg bw/day or 1382 mg enzyme concentrate dry matter/kg bw/day. Dermal toxicity study was a single dose study, dose being 2.0 mL/kg of a 0.62% w/v solution, i.e. 12.4 mg/kg, in water or buffer, respectively. This gave only mild local skin reactions. This outcome is supported by the knowledge of low likelihood of absorption of enzymes through the skin due to the physico-chemical properties of the enzyme protein. Inhalation toxicity study was waived because exposure is too low to exert any toxicity. Potential exposure by inhalation to an amount of enzyme, which is toxicologically relevant, is unrealistic due to the stringent work practices and the formulation of enzymes, enforced because of the risk of sensitization by inhalation. Based on repeated dose oral and dermal studies and weight of evidence, alpha-amylase does not exert any repeated dose oral, dermal or inhalation toxicity to workers or consumers.Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Toxicological data has been generated within the enzyme producing industry during the last 40 years. Substantial documentation on the safety of the production strains has been generated, and the enzyme test materials are thoroughly characterized. High quality studies for all relevant endpoints for in vivo studies as well as in vitro studies show that industrial enzymes from well-known and well characterized production strains have very similar safety profiles across the catalytic activities. Read-across can therefore be applied for the majority of toxicological endpoints. The database can therefore be considered of high quality. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/596f6702-7569-44f9-93fe-b6194efae890/documents/IUC5-80c4c6bb-7604-4169-b841-6792b08db61f_b8dff54b-b04d-49c2-8447-04612d41cca8.html,,,,,, "Amylase, α-",9000-90-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/596f6702-7569-44f9-93fe-b6194efae890/documents/IUC5-80c4c6bb-7604-4169-b841-6792b08db61f_b8dff54b-b04d-49c2-8447-04612d41cca8.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,12.4 mg/kg bw/day,,rabbit "Amylase, α-",9000-90-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/596f6702-7569-44f9-93fe-b6194efae890/documents/IUC5-80c4c6bb-7604-4169-b841-6792b08db61f_b8dff54b-b04d-49c2-8447-04612d41cca8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,382 mg/kg bw/day",,rat "Amylase, α-",9000-90-2,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyInformation.KeyInformation): The acute oral and inhalation toxicity of alpha-amylase has been tested. The acute oral toxicity test and the acute inhalation toxicity test were short-term toxicity tests conducted according to OECD guidelines, and in compliance with GLP. No acute dermal toxicity test was conducted but a 28-day repeated dose dermal toxicity study in rabbits has been performed. The conclusion was that alpha-amylase is non-toxic by acute oral and inhalation exposure (GHS Toxicity category V). Based on weight of evidence, alpha-amylase does not exert any acute dermal toxicity under foreseeable realistic exposures for both workers and consumers.Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Toxicological data has been generated within the enzyme producing industry during the last 40 years. Substantial documentation on the safety of the production strains have been generated, and the enzyme test materials are thoroughly characterized. High quality studies for all relevant endpoints, in vivo studies as well as in vitro studies, show that industrial enzymes from well-known and well-characterized production strains have very similar safety profiles across the catalytic activities. Read-across can therefore be applied for the majority of toxicological endpoints. The database can thus be considered of high quality.Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Toxicological data has been generated within the enzyme producing industry during the last 40 years. Substantial documentation on the safety of the production strains have been generated, and the enzyme test materials are thoroughly characterized. High quality studies for all relevant endpoints, in vivo studies as well as in vitro studies, show that industrial enzymes from well-known and well-characterized production strains have very similar safety profiles across the catalytic activities. Read-across can therefore be applied for the majority of toxicological endpoints. The database can thus be considered of high quality. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/596f6702-7569-44f9-93fe-b6194efae890/documents/IUC5-bdb89aa3-c907-4787-bfad-733f4a153166_b8dff54b-b04d-49c2-8447-04612d41cca8.html,,,,,, "Amylase, α-",9000-90-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/596f6702-7569-44f9-93fe-b6194efae890/documents/IUC5-bdb89aa3-c907-4787-bfad-733f4a153166_b8dff54b-b04d-49c2-8447-04612d41cca8.html,,oral,LD50,"2,562 mg/kg bw",no adverse effect observed, "Amylase, α-",9000-90-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/596f6702-7569-44f9-93fe-b6194efae890/documents/IUC5-bdb89aa3-c907-4787-bfad-733f4a153166_b8dff54b-b04d-49c2-8447-04612d41cca8.html,,inhalation,LC50,"4,960 mg/m3",no adverse effect observed, "Amylase, β-",9000-91-3,"It was concluded that oral administration of beta-amylase, batch PPY36295 to Sprague-Dawley rats at doses up to 100% of the beta-amylase batch (equivalent to 1324 mg enzyme concentrate dry matter/kg/day) for 90 days was well-tolerated and did not cause any adverse change. The no-observed adverse-effect level (NOAEL) was considered to be 100% of the beta-amylase batch, equivalent to 1324 mg enzyme concentrate dry matter/kg/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Toxicological data has been generated within the enzyme producing industry during the last 40 years. Substantial documentation on the safety of the production strains has been generated, and the enzyme test materials are thoroughly characterized. High quality studies for all relevant endpoints for in vivo studies as well as in vitro studies show that industrial enzymes from well-known and well characterized production strains have very similar safety profiles across the catalytic activities. Read-across can therefore be applied for the majority of toxicological endpoints. The database can therefore be considered of high quality. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/caf705f0-87c9-4c67-913d-c3e22d973de4/documents/788428a8-3d16-47d8-af7b-1270be4b3d92_28d2f8cf-229a-4f84-b4e3-ff962d5ff15d.html,,,,,, "Amylase, β-",9000-91-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/caf705f0-87c9-4c67-913d-c3e22d973de4/documents/788428a8-3d16-47d8-af7b-1270be4b3d92_28d2f8cf-229a-4f84-b4e3-ff962d5ff15d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,324 mg/kg bw/day",, "Amylase, β-",9000-91-3,"The acute toxicity of beta-amylase was not tested, as a 13-week repeated dose toxicity study is available. The repeated-dose toxicity study revealed that oral administration of beta-amylase, batch PPY36295 to Sprague-Dawley rats at doses up to 100% of the beta-amylase batch (equivalent to 1324 mg enzyme concentrate dry matter/kg/day) for 90 days was well-tolerated and did not cause any adverse change. The no-observed adverse-effect level (NOAEL) was considered to be 100% of the beta-amylase batch, equivalent to 1324 mg enzyme concentrate dry matter/kg/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Toxicological data has been generated within the enzyme producing industry during the last 40 years. Substantial documentation on the safety of the production strains have been generated, and the enzyme test materials are thoroughly characterized. High quality studies for all relevant endpoints, in vivo studies as well as in vitro studies, show that industrial enzymes from well-known and well-characterized production strains have very similar safety profiles across the catalytic activities. Read-across can therefore be applied for the majority of toxicological endpoints. The database can thus be considered of high quality. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/caf705f0-87c9-4c67-913d-c3e22d973de4/documents/bcb71eae-b6a3-4809-aafa-f329ec030f56_28d2f8cf-229a-4f84-b4e3-ff962d5ff15d.html,,,,,, "Androst-4-ene-3,17-dione",63-05-8,"Oral, 4 weeks (Rat-Wistar, GLP, non-audited draft, doses: 0 / 15 / 50 / 150 mg/kg, once daily, equivalent to OECD TG407): LOAEL 15 mg/kg [Schering AG, report no. AG16, 1996-11-12]Subcutaneous, 4 weeks (Rat-Wistar, GLP, non-audited draft, doses: 0 / 5 / 15 / 50 mg/kg, once daily): LOAEL: 5 mg/kg [Schering AG, report no. AY75, 2000-04-10]Results of repeated oral studies published within scope of NTP (NIH, US) assessment [NTP Technical Report 560, NIH Publication No. 10-5901, September 2010]:Oral, 14 weeks (Rat-Wistar, GLP, doses 0 / 1 / 5 / 10 / 20 / 50 mg/kg, once daily, OECD TG408): NOAEL 5 mg/kgOral, 14 weeks (Mouse-B6C3F1, GLP, doses 0 / 1 / 5 / 10 / 20 / 50 mg/kg, once daily, OECD TG408): LOAEL 50 mg/kg ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/309b264d-e433-466d-ade3-d7ab7f0666aa/documents/IUC5-da56da7b-7c94-4220-8bf0-0af8deb8720c_215d0b18-a714-4ee8-9c48-c75435594dbe.html,,,,,, "Androst-4-ene-3,17-dione",63-05-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/309b264d-e433-466d-ade3-d7ab7f0666aa/documents/IUC5-da56da7b-7c94-4220-8bf0-0af8deb8720c_215d0b18-a714-4ee8-9c48-c75435594dbe.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat "Androst-4-ene-3,17-dione",63-05-8,"Oral (Rat-Wistar, males, GLP, similar to OECD TG423): LD50 between 500 and 1000 mg/kg (Schöbel and Flowers, 1989)Oral (Rat-Wistar, females, GLP, similar to OECD TG423): LD50 > 500 mg/kg (Treher, 1994)Dermal (Rat-Wistar, GLP, similar to OECD TG402, combined study on acute toxicity and on local tolerance): LD50 > 2000 mg/kg (Kurth, 1995) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/309b264d-e433-466d-ade3-d7ab7f0666aa/documents/IUC5-07354303-b941-4fd4-95d9-89ca600402e6_215d0b18-a714-4ee8-9c48-c75435594dbe.html,,,,,, "Androst-4-ene-3,17-dione",63-05-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/309b264d-e433-466d-ade3-d7ab7f0666aa/documents/IUC5-07354303-b941-4fd4-95d9-89ca600402e6_215d0b18-a714-4ee8-9c48-c75435594dbe.html,,oral,LD50,> 500 mg/kg bw,adverse effect observed, "Androst-4-ene-3,17-dione",63-05-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/309b264d-e433-466d-ade3-d7ab7f0666aa/documents/IUC5-07354303-b941-4fd4-95d9-89ca600402e6_215d0b18-a714-4ee8-9c48-c75435594dbe.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1 alpha-Methyl-4-androstene-3,17-dione",4136-62-3,"LD50 oral (rat): > 2000 mg/kg bw [Draft report, Kurth 1998]LD50 dermal (rat): > 2000 mg/kg bw [Draft report, Treher 1998] ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c852e92a-f4b5-4e9a-955e-d14ec3dea08c/documents/IUC5-7279a759-6649-474a-aeae-4653820df97e_da0f2c19-7f5b-4e24-83f5-57983699b12d.html,,,,,, "1 alpha-Methyl-4-androstene-3,17-dione",4136-62-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c852e92a-f4b5-4e9a-955e-d14ec3dea08c/documents/IUC5-7279a759-6649-474a-aeae-4653820df97e_da0f2c19-7f5b-4e24-83f5-57983699b12d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1 alpha-Methyl-4-androstene-3,17-dione",4136-62-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c852e92a-f4b5-4e9a-955e-d14ec3dea08c/documents/IUC5-7279a759-6649-474a-aeae-4653820df97e_da0f2c19-7f5b-4e24-83f5-57983699b12d.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "7 beta-Hydroxy-3 beta,15 alpha-dipivaloyloxy-5-androsten-17-one",85390-94-9,"Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg[Schering AG, Report No. X240 -draft-, 1997-08-22]Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg[Schering AG, Report No. X302 -draft-, 1998-09-10] ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a12f9ef-4138-4b90-a6b4-be73c713775e/documents/IUC5-ac023e1c-b308-4f12-95c0-25e7aadc8ed2_92512b06-68af-4ecf-bf7b-88d5ca1978bc.html,,,,,, "3 beta,7 alpha,15 alpha-Trihydroxy-5-androsten-17-one",2963-69-1,"No acute toxicity studies are available for 3 beta,7 alpha,15 alpha-Trihydroxy-5-androsten-17-one. However, there are acute toxicity studies for the stereoisomer 3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one: Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg [Schering AG, Report No. X298 -draft-, 1998-09-09] Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg [Schering AG, Report No. X285 -draft-, 1998-08-21] Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch rel-1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch rel-1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/878faf70-6824-48b7-b0d3-324960403c89/documents/IUC5-e4445554-cff6-4187-b10c-7f41209b47b3_e577ef7b-bac5-4c69-a804-ca7924ba55cf.html,,,,,, "3 beta,7 alpha,15 alpha-Trihydroxy-5-androsten-17-one",2963-69-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/878faf70-6824-48b7-b0d3-324960403c89/documents/IUC5-e4445554-cff6-4187-b10c-7f41209b47b3_e577ef7b-bac5-4c69-a804-ca7924ba55cf.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "3 beta,7 alpha,15 alpha-Trihydroxy-5-androsten-17-one",2963-69-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/878faf70-6824-48b7-b0d3-324960403c89/documents/IUC5-e4445554-cff6-4187-b10c-7f41209b47b3_e577ef7b-bac5-4c69-a804-ca7924ba55cf.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "3 beta,7 beta,15 alpha-Trihydroxy-5-androsten-17-one",85390-93-8,"Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg[Schering AG, Report No. X298 -draft-, 1998-09-09]Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg[Schering AG, Report No. X285 -draft-, 1998-08-21] ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79acfbb5-093b-4aa7-9bde-ed2e518e6d9e/documents/IUC5-26d27a02-1d21-4241-a0cc-85c66214abda_6f6ba08e-4799-4465-830c-89a4cfff2195.html,,,,,, "3,3-Ethylenedioxy-17 alpha-hydroxy-5-androstene-17 beta-carbonitrile",83196-58-1,"Oral (Rat, comparable to OECD TG 423): LD50 > 2000 mg/kg[Schering AG, Report -draft-, 1992-08-10]Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg[Schering AG, Report No. X027 -draft-, 1995-07-19] ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74d73e53-bc1e-47c0-9079-4aa604e0e3f1/documents/IUC5-b05a87fb-417c-4d7a-bb17-6f827eef4ee5_e2af8371-0704-4732-819a-9699171e9726.html,,,,,, "(1R,2S,8S,10S,11S,13R,14R,15S,17S)-1,8-difluoro- 14,17dihydroxy-2,13,15-trimethyl-5-oxotetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-3,6-diene-14-carbothioic S-acid",80473-92-3, Information available from acute oral toxicity test showed adverse effects to female mice at highest dose of 2000 mg/kg bw. LD50 for oral acute toxicity was not determined. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57a73a4a-df3b-4f95-b1ce-7025c1d2d0ac/documents/a92749c4-512b-477f-bab7-9494552abc7c_52282ca5-8dd3-4cc7-ade4-c4029d23992c.html,,,,,, "(1R,2S,8S,10S,11S,13R,14R,15S,17S)-1,8-difluoro- 14,17dihydroxy-2,13,15-trimethyl-5-oxotetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-3,6-diene-14-carbothioic S-acid",80473-92-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57a73a4a-df3b-4f95-b1ce-7025c1d2d0ac/documents/a92749c4-512b-477f-bab7-9494552abc7c_52282ca5-8dd3-4cc7-ade4-c4029d23992c.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, "Androsta-1,4-diene-3,17-dione",897-06-3,"Oral, 4 weeks (Rat-Wistar, GLP, non-audited draft, doses: 0 / 15 / 50 / 150 mg/kg, once daily, equivalent to OECD TG407): LOAEL 15 mg/kg [Schering AG, report no. AG16, 1996-11-12] ; read-across from androstenedioneSubcutaneous, 4 weeks (Rat-Wistar, GLP, non-audited draft, doses: 0 / 5 / 15 / 50 mg/kg, once daily): LOAEL: 5 mg/kg [Schering AG, report no. AY75, 2000-04-10] ; read-across from androstenedione Results of repeated oral studies published within scope of NTP (NIH, US) assessment [NTP Technical Report 560, NIH Publication No. 10-5901, September 2010]:Oral, 14 weeks (Rat-Wistar, GLP, doses 0 / 1 / 5 / 10 / 20 / 50 mg/kg, once daily, OECD TG408): NOAEL 5 mg/kg; read-across from androstenedioneOral, 14 weeks (Mouse-B6C3F1, GLP, doses 0 / 1 / 5 / 10 / 20 / 50 mg/kg, once daily, OECD TG408): LOAEL 50 mg/kg; read-across from androstenedione Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study is GLP compliant and is of high quality (Klimisch score=1) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/15295bb4-443d-4249-a706-01a8ec60fbe7/documents/IUC5-646ce000-2da2-470e-a81a-b2670fdc1719_aa89655b-c8a8-4f0b-9eb6-6a466e6560e3.html,,,,,, "Androsta-1,4-diene-3,17-dione",897-06-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/15295bb4-443d-4249-a706-01a8ec60fbe7/documents/IUC5-646ce000-2da2-470e-a81a-b2670fdc1719_aa89655b-c8a8-4f0b-9eb6-6a466e6560e3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat "Androsta-1,4-diene-3,17-dione",897-06-3,"The acute toxicity (LD50) of androstadiendion in rats is > 2000 mg/kg bw after oral (Stark & Wick, 1998; Kurth, 1994) or dermal (Kurth, 1995) administration. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The studies are of high quality (Klimisch score=1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15295bb4-443d-4249-a706-01a8ec60fbe7/documents/IUC5-7c76def1-e58c-47b3-97fe-fd41d3fedff1_aa89655b-c8a8-4f0b-9eb6-6a466e6560e3.html,,,,,, "Androsta-1,4-diene-3,17-dione",897-06-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15295bb4-443d-4249-a706-01a8ec60fbe7/documents/IUC5-7c76def1-e58c-47b3-97fe-fd41d3fedff1_aa89655b-c8a8-4f0b-9eb6-6a466e6560e3.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Androsta-1,4-diene-3,17-dione",897-06-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15295bb4-443d-4249-a706-01a8ec60fbe7/documents/IUC5-7c76def1-e58c-47b3-97fe-fd41d3fedff1_aa89655b-c8a8-4f0b-9eb6-6a466e6560e3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "(5α)-Androsta-2,16-dien-17-yl acetate",50588-42-6,"No studies are available for didenac and information is based on read across to a similar substance, dienone. Based on read across to dienone, the oral discriminating dose for didenac is considered to be 500 mg/kg bw in male and female rats. The dermal LD50 is >2000 mg/kg in male and female rats. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbe88b2a-3cef-4b42-9604-ad939f7888ef/documents/IUC5-f5a7cdcd-5fe9-4606-ac00-4e2f80a261f5_58b04daa-2ca3-4062-99a5-e5afe1eb63e8.html,,,,,, "(5α)-Androsta-2,16-dien-17-yl acetate",50588-42-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbe88b2a-3cef-4b42-9604-ad939f7888ef/documents/IUC5-f5a7cdcd-5fe9-4606-ac00-4e2f80a261f5_58b04daa-2ca3-4062-99a5-e5afe1eb63e8.html,,oral,discriminating dose,500 mg/kg bw,adverse effect observed, "2,3-Epoxy-1H-cyclopenta[a]phenanthrene,androstan-17-ol",119302-19-1,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/683c5049-9f8b-48ad-afc3-135b1b0b0082/documents/IUC5-4646bb19-dd5e-42ff-a43e-b7b60ed43c69_2bd662a3-9b93-41e3-af59-aa2a2fd11311.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "2,3-Epoxy-1H-cyclopenta[a]phenanthrene,androstan-17-ol",119302-19-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/683c5049-9f8b-48ad-afc3-135b1b0b0082/documents/IUC5-5b496a4b-512e-4f6a-b140-14bcdc9b13bc_2bd662a3-9b93-41e3-af59-aa2a2fd11311.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Androstan-17-one,2,3-epoxy-16-(1-pyrrolidinyl)-(2α,3α,5α,16α,17β)-",159325-45-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f1c1770-0258-4bd2-8765-599a1bb2688a/documents/IUC5-2ee0590a-3751-4746-a3d4-7a2faeb098ef_c21ca433-2f7c-414b-b0a3-362eae726b5d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Androstan-17-one,2,3-epoxy-16-(1-pyrrolidinyl)-(2α,3α,5α,16α,17β)-",159325-45-8,"The oral LD50 and dermal LD50 in rats is considered to be >2,000 mg/kg bw. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f1c1770-0258-4bd2-8765-599a1bb2688a/documents/IUC5-e5d1c54c-d105-4162-bf89-0741eaa8c868_c21ca433-2f7c-414b-b0a3-362eae726b5d.html,,,,,, "Androstan-17-one,2,3-epoxy-16-(1-pyrrolidinyl)-(2α,3α,5α,16α,17β)-",159325-45-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f1c1770-0258-4bd2-8765-599a1bb2688a/documents/IUC5-e5d1c54c-d105-4162-bf89-0741eaa8c868_c21ca433-2f7c-414b-b0a3-362eae726b5d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Androsterone tosylate,10429-07-9,The oral LD50 value of TRANTOS in Wistar rats was established to exceed 2000 mg/kg body weight. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5af0256d-bfe3-48df-b96f-a163a4847c66/documents/IUC5-f4f686bb-59df-42e7-a7c2-fc2e58ef7d49_216df16f-c2c1-46bc-9bb0-6fe35c0d1b35.html,,,,,, Androsterone tosylate,10429-07-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5af0256d-bfe3-48df-b96f-a163a4847c66/documents/IUC5-f4f686bb-59df-42e7-a7c2-fc2e58ef7d49_216df16f-c2c1-46bc-9bb0-6fe35c0d1b35.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 17 beta-Acetoxy-5 alpha-androstan-3-one,1164-92-7,"Oral (Rat, GLP, not audited report; OECD 423): LD50 > 2000 mg/kg[Schering AG, Report X235; 1997-08-15]Dermal (Rat, GLP, not audited report; OECD 402): LD50 > 2000 mg/kg[Schering AG, Report X296; 1998-09-24] ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/056e4576-f4e7-4acb-983f-027c46f2c776/documents/IUC5-02c99ed2-90a3-431c-b1b2-08c08ec68aa8_218e632d-3c5e-4af2-bd01-5f899352a507.html,,,,,, "Anthra[2,1,9-mna]naphth[2,3-h]acridine-5,10,15(16H)-trione",3271-76-9, Repeated dose toxicity via oral route NOEL 1000 mg/kg bw in male and female Sprague-Dawley rats (OECD 422) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f493592a-4c46-4140-9741-b3bda8a77044/documents/a14ac02c-2250-44a5-a663-9a3cead2002b_8dcb8339-a7b6-49f7-a52d-f6d83324d557.html,,,,,, "Anthra[2,1,9-mna]naphth[2,3-h]acridine-5,10,15(16H)-trione",3271-76-9, No adverse effects were observed in acute toxicity studies up to the highest dose level tested ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f493592a-4c46-4140-9741-b3bda8a77044/documents/e4fb9a80-6861-4137-8877-6d66b003eb52_8dcb8339-a7b6-49f7-a52d-f6d83324d557.html,,,,,, Anthracene oil,90640-80-5,"Oral route: The longterm (chronic) repeated dose oral toxicity of anthracene oil (BaP <50 ppm, AOL) is assessed using an oral TDI value (tolerable daily intake) of 0.04 mg/kg bw/day derived for phenanthrene by Baars et al./RIVM 2001, The Netherlands (see study record/IUCLID 7.5.1, entry 1). This evaluation on expert judgement is based on comprehensive experimental data (rodents, subchronic) for the aromatic >EC9-EC16 fraction. This value is considered to be a conservative estimate for individual components of the mixture with missing toxicity data. Inhalation route: The correlate of the longterm oral reference value of 0.04 mg/kg bw/d results - when re-calculated using respective assessment factors - in a TCA value (Tolerable Concentration in Air) of 0.14 mg/m3, considered to be a virtually safe lifelong exposure for the general population. This was used as starting point for DNEL-derivation. Alternatively, evaluation of the repeated dose inhalation toxicity of anthracene oil was based on information available from a sub-chronic study with the closely structure-related tar oil creosote (see study record/IUCLID 7.5.1, entry 2) Exposure of rats to creosote aerosols for 90 days resulted in systemic and local toxic effects with a NOAEC of 5.4  and 22 mg/m³, concentrations mainly aerosolic (analytical) and aerosolic and gaseous (ominal), respectively.    ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3587790-275e-44af-bcd9-7193c8cda8f0/documents/505910f4-7cd8-4ec1-ac51-b3b549bd3932_b85f139a-1238-4f62-be72-316cb8bb5c76.html,,,,,, Anthracene oil,90640-80-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3587790-275e-44af-bcd9-7193c8cda8f0/documents/505910f4-7cd8-4ec1-ac51-b3b549bd3932_b85f139a-1238-4f62-be72-316cb8bb5c76.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,22 mg/m3,,rat Anthracene oil,90640-80-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3587790-275e-44af-bcd9-7193c8cda8f0/documents/505910f4-7cd8-4ec1-ac51-b3b549bd3932_b85f139a-1238-4f62-be72-316cb8bb5c76.html,Chronic toxicity – systemic effects,oral,,0.04 mg/kg bw/day,,other:related to humans Anthracene oil,90640-80-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3587790-275e-44af-bcd9-7193c8cda8f0/documents/505910f4-7cd8-4ec1-ac51-b3b549bd3932_b85f139a-1238-4f62-be72-316cb8bb5c76.html,Chronic toxicity – systemic effects,inhalation,,0.07 mg/m3,,primate Anthracene oil,90640-80-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3587790-275e-44af-bcd9-7193c8cda8f0/documents/505910f4-7cd8-4ec1-ac51-b3b549bd3932_b85f139a-1238-4f62-be72-316cb8bb5c76.html,Repeated dose toxicity – local effects,inhalation,NOAEC,22 mg/m3,adverse effect observed,rat Anthracene oil,90640-80-5," No data is available for anthracene oil (AOL) itself. The structurally related tar oil creosote is used as supporting (source) substance instead. Oral, inhalation, and dermal acute toxicity studies have been carried out with creosote as test material. LD/LC50 values were clearly above 2000 mg/kg bw or 5000 mg/m³, respectively. These results are adopted for the target substance anthracene oil based on the structural similarity of both substances. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3587790-275e-44af-bcd9-7193c8cda8f0/documents/831235f9-2191-45ac-ac52-436070f44fe3_b85f139a-1238-4f62-be72-316cb8bb5c76.html,,,,,, Anthracene oil,90640-80-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3587790-275e-44af-bcd9-7193c8cda8f0/documents/831235f9-2191-45ac-ac52-436070f44fe3_b85f139a-1238-4f62-be72-316cb8bb5c76.html,,oral,LD50,"4,030 mg/kg bw",no adverse effect observed, Anthracene oil,90640-80-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3587790-275e-44af-bcd9-7193c8cda8f0/documents/831235f9-2191-45ac-ac52-436070f44fe3_b85f139a-1238-4f62-be72-316cb8bb5c76.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Anthracene oil,90640-80-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3587790-275e-44af-bcd9-7193c8cda8f0/documents/831235f9-2191-45ac-ac52-436070f44fe3_b85f139a-1238-4f62-be72-316cb8bb5c76.html,,inhalation,discriminating conc.,"5,000 mg/m3",no adverse effect observed, Anthranilamide,88-68-6,"In a 2 years (feed) oral repated dose toxicity study, effects for clinical pathology at ~6 and 12 months and for anatomic pathology (organ weights, gross and microscopic pathology) at the end of 12 months.In a 15-day (gavag) and 28-day (feed) oral repeated dose toxicity study, effects were observed on the thyroid. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7dc45a28-b42e-4b16-a11e-b7626ee050aa/documents/IUC5-3b6b81a1-f002-4126-95fe-76b308ef043a_93cb87c9-c26c-4690-8a59-af77120d52d5.html,,,,,, Anthranilamide,88-68-6,"In an acute oral toxicity study, the LD50 was determined to be ca. 2200 mg/kg bw for male and female rats. In an acute inhalation toxicity study, the LC50 was determined to be >5.4 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7dc45a28-b42e-4b16-a11e-b7626ee050aa/documents/IUC5-1925dab6-7426-41ef-b018-208a07fe8af1_93cb87c9-c26c-4690-8a59-af77120d52d5.html,,,,,, Anthranilamide,88-68-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7dc45a28-b42e-4b16-a11e-b7626ee050aa/documents/IUC5-1925dab6-7426-41ef-b018-208a07fe8af1_93cb87c9-c26c-4690-8a59-af77120d52d5.html,,oral,LD50,"2,200 mg/kg bw",adverse effect observed, Antimony sulphide,1345-04-6,"NOTE: This dossier corresponds to an interim submission providing the status update of a study conducted according to OECD Guideline 413 including i) BAL and measurements of lung burden, ii) cardiovascular effect evaluation and iii) toxicokinetic assessment requested by ECHA according to a decision on substance evaluation on diantimony trisulfide (SEV-D-2114499401-46-01/F). The dose descriptor values and read across strategy for repeated dose from the previous version of the dossier have been maintained in this intermediate update. Other critical testing is planned/ongoing. Once the study results are available, all dose descriptor and corresponding DNELs/exposure scenarios, the classification and read across strategy will be revised. Based on an in-depth analysis of the available information (see read-across justification in Section 13 of the IUCLID dataset), it is the hypothesis that human health effects of antimony trisulfide can be read-across from data on trivalent antimony substances.   Two repeated dose oral studies (Sunagawa, 1981; Hext et al., 1999) conducted with the read across substance, diantimony trioxide, suggest that the substance may be toxic to the liver. This being based on a 10 % increase in liver weight. While the first study (Hext et al., 1999) exhibited significantly elevated ASAT values and significantly decreased ALP values, the other one (Sunagawa, 1981) revealed both ASAT and ALP levels to be significantly elevated. However, in the absence of histological change or any clinical signs of antimony intoxication to support liver adversity, the differences are regarded as adaptive or incidental to treatment with diantimony trioxide. Hence, a NOAEL of 1686 mg/kg/d for liver toxicity is suggested.    After ECHA Decision on a compliance check on diantimony trisulfide (CCH-D-2114503831-58-01/F), a combined repeated dose toxicity study with the reproduction / developmental toxicity screening was conducted in rats according to OECD Guideline 422, in compliance with GLP. Four groups of ten Wistar Han rats (males and females) were exposed by oral gavage to increasing concentrations of the antimony trisulfide (0, 100, 300 and 1000 mg/kg/day). All doses were administered at a constant volume of 4 mL/kg body weight. Dried and de-acidified corn oil was used as a vehicle. According to the study design, males were treated for 29 days and females were treated for 42-55 days. The following investigations were performed: body weight, clinical signs, food consumption, clinical pathology investigations (hematology and clinical chemistry), macroscopic observations and organ weights. No mortality occurred throughout the study due to the administration of the test substance. Salivation, swelling, chromodacryorrhea and ptosis were noted in one male and female treated at 100 mg/kg/day and among animals of the 300 (males only) and 1000 mg/kg/day were non-treatment related. Functional tests (Hearing ability, pupillary reflex, static righting reflex and grip strength), did not reveal changes attributable to the test substance. Body weight and body weight gain of treated animals did not show differences throughout the study when compared to the control group. The food consumption was comparable in all groups. Changes in the hematological parameters (total WBCs, neutrophil, lymphocyte, monocyte, basophil counts) were found to be increased at 1000 mg/kg/day in males and females respectively. Changes in clinical chemistry (alkaline phosphatase and urea levels) were found in males at 1000 mg/kg bw/day. No treatment related changes were observed in clinical findings in females. Black-brown discoloration was observed in the stomach, ileum, cecum and colon of the 1000 mg/kg/day group males. Test substance-related higher liver weights (relative to body weights) were noted in the 300 and 1000 mg/kg/day males and the 1000 mg/kg/day females. No adverse findings were recorded in histopathology. Hormone analysis revealed non-adverse lower T4 levels in males at 100 mg/kg bw/day. Under the study conditions, the NOAEL for general toxicity was considered to be 1000 mg/kg/day for males and females (Crezee, 2023).   Overall, these new results confirmed and supported the hypothesis of a similar toxicological profile within the trivalent antimony substances.   In order to fully elucidate the toxicological profile of diantimony trisulfide and in line with the ECHA Decision (SEV-D-2114499401-46-01/F), further investigations are planned by the way of a 90-day inhalation study in rats including BAL and measurement of lung burden, cardiovascular effect evaluations and toxicokinetic assessment. Additional information about delays and expected time plan is provided as part of this dossier update.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1917afb4-7116-4711-819b-8ba68f1d2037/documents/ebfab0a5-4ed9-481f-afd3-616629aeea3e_48c3d4c1-f35f-45e7-a663-90614acf9aab.html,,,,,, Antimony sulphide,1345-04-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1917afb4-7116-4711-819b-8ba68f1d2037/documents/ebfab0a5-4ed9-481f-afd3-616629aeea3e_48c3d4c1-f35f-45e7-a663-90614acf9aab.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,686 mg/kg bw/day",,rat Antimony trifluoride,7783-56-4," There are five study records for acute toxicity, which are reliable with restrictions: one with oral administration and four with subcutaneous administration. Further one study record with unclear administration of antimontrifluoride has no sufficient reliability and is therefore not used for assessment. A mouse LD50 oral 804 mg/kg bw was reported. According to this result a classification for acute toxicity oral in Category 4 based on GHS criteria is recommended. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7b28bcb-345b-4875-8c44-d69f9f39abdd/documents/e7540f88-721c-4c0e-9885-2e8fe367c86f_2155466f-5d9e-4874-9d55-9baf8129966c.html,,,,,, Antimony trifluoride,7783-56-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7b28bcb-345b-4875-8c44-d69f9f39abdd/documents/e7540f88-721c-4c0e-9885-2e8fe367c86f_2155466f-5d9e-4874-9d55-9baf8129966c.html,,oral,LD50,804 mg/kg bw,adverse effect observed, "Arabinofuranosidase, α-l-",9067-74-7," The oral administration of arabinofuranosidase, batch PPH40331 to Han Wistar rats at doses up to 100% of the arabinofuranosidase batch (equivalent to 1116 mg TOS/kg/day) for 13 weeks was well-tolerated and did not cause any adverse change. The no-observed adverse-effect level (NOAEL) was considered to be 100% of the arabinofuranosidase, batch PPH40331 (equivalent to 1116 mg TOS/kg/day). The repeated dose inhalation and dermal toxicity studies were waived. - The dermal study was waived because of the low likelihood of absorption of enzymes through the skin due to the physico-chemical properties of the enzyme protein. - The inhalation study was waived because exposure is too low to exert any toxicity. Potential exposure by inhalation to an amount of enzyme that toxicologically relevant is unrealistic, due to the formulation of enzymes and the stringent work practices enforced because of the risk of sensitisation by inhalation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8abec6f7-cb9d-419c-aba6-02f14b5bbb64/documents/dc4c240c-ca49-4da5-b419-29450f218d90_a79483a7-533a-4f62-bb7d-3538ad5ab4c5.html,,,,,, "Arabinofuranosidase, α-l-",9067-74-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8abec6f7-cb9d-419c-aba6-02f14b5bbb64/documents/dc4c240c-ca49-4da5-b419-29450f218d90_a79483a7-533a-4f62-bb7d-3538ad5ab4c5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,116 mg/kg bw/day",,rat "Arabinofuranosidase, α-l-",9067-74-7," No acute oral toxicity study was available, however, from a repeated dose toxicity study, no effects were seen in concentrations up to 1116 mg TOS/kg/day. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8abec6f7-cb9d-419c-aba6-02f14b5bbb64/documents/c3b6ed1a-c197-4cf1-8625-bbb89bcd9f63_a79483a7-533a-4f62-bb7d-3538ad5ab4c5.html,,,,,, "Aromatic hydrocarbons, C10-13, reaction products with branched nonene, sulfonated, sodium salts",1258274-08-6," A Combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test was performed with Sodium alkylnaphthalene sulfonate in 10 Wistar Han rats/dose/sex by oral gavage, followed by a 14-day recovery period for control and high dosed males applying 5 animals/dose. The dose levels selected were 0, 100, 300 and 1000 mg/kgbw/day. Duration of dosing was for males 29 days and females 40-47 days. The study resulted in the following NOAELs: Parental NOAEL: 300 mg/kg/day Reproduction NOAEL: at least 1000 mg/kg/day Developmental NOAEL: at least 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8a7a40e-fbfd-4a32-b102-6264ed4d6afd/documents/IUC5-b4c00be2-2fc5-41ca-914f-da82635b86fb_c19190cf-0ef3-414e-8af5-7815bf07b63e.html,,,,,, "Aromatic hydrocarbons, C10-13, reaction products with branched nonene, sulfonated, sodium salts",1258274-08-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8a7a40e-fbfd-4a32-b102-6264ed4d6afd/documents/IUC5-b4c00be2-2fc5-41ca-914f-da82635b86fb_c19190cf-0ef3-414e-8af5-7815bf07b63e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Aromatic hydrocarbons, C10-13, reaction products with branched nonene, sulfonated, sodium salts",1258274-08-6," Acute toxicity of Aromatic hydrocarbons, C10-13, reaction products with branched nonene, sulphonated, sodium salts is low. Oral LD50 is in range 2000-5000, and dermal LD50 >2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8a7a40e-fbfd-4a32-b102-6264ed4d6afd/documents/IUC5-574087fd-2aea-4731-8de2-604890dbe082_c19190cf-0ef3-414e-8af5-7815bf07b63e.html,,,,,, "Aromatic hydrocarbons, C10-13, reaction products with branched nonene, sulfonated, sodium salts",1258274-08-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8a7a40e-fbfd-4a32-b102-6264ed4d6afd/documents/IUC5-574087fd-2aea-4731-8de2-604890dbe082_c19190cf-0ef3-414e-8af5-7815bf07b63e.html,,oral,LD50,"4,470 mg/kg bw",adverse effect observed, "Aromatic hydrocarbons, C10-13, reaction products with branched nonene, sulfonated, sodium salts",1258274-08-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8a7a40e-fbfd-4a32-b102-6264ed4d6afd/documents/IUC5-574087fd-2aea-4731-8de2-604890dbe082_c19190cf-0ef3-414e-8af5-7815bf07b63e.html,,dermal,discriminating dose,"2,000 mg/kg bw",adverse effect observed, "Aromatic hydrocarbons, C7-8, ethylene-manuf.-by-product",90989-43-8,"Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene / n-hexane - when present at 10%). Adequate information is available on the constituents to characterise the repeated dermal hazards of these streams. Adequate information is available on the constituents to characterise the repeated inhalation hazards of these streams. Adequate information is available on the constituents to characterise the repeated oral hazards of these streams. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b53e58c7-77e2-4f0e-a0cb-c680c33eaf3e/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_00983b96-6504-420c-83f9-558110a38982.html,,,,,, "Aromatic hydrocarbons, C7-8, ethylene-manuf.-by-product",90989-43-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b53e58c7-77e2-4f0e-a0cb-c680c33eaf3e/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_00983b96-6504-420c-83f9-558110a38982.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Aromatic hydrocarbons, C7-8, ethylene-manuf.-by-product",90989-43-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b53e58c7-77e2-4f0e-a0cb-c680c33eaf3e/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_00983b96-6504-420c-83f9-558110a38982.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Aromatic hydrocarbons, C7-8, ethylene-manuf.-by-product",90989-43-8,"Available data for one stream within this category (CAS 68516-20-1) and data on specific constituents (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Adequate information is available to characterise the short-term hazards of these streams. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b53e58c7-77e2-4f0e-a0cb-c680c33eaf3e/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_00983b96-6504-420c-83f9-558110a38982.html,,,,,, "Aromatic hydrocarbons, C7-8, ethylene-manuf.-by-product",90989-43-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b53e58c7-77e2-4f0e-a0cb-c680c33eaf3e/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_00983b96-6504-420c-83f9-558110a38982.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Aromatic hydrocarbons, C7-8, ethylene-manuf.-by-product",90989-43-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b53e58c7-77e2-4f0e-a0cb-c680c33eaf3e/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_00983b96-6504-420c-83f9-558110a38982.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aromatic hydrocarbons, C7-8, ethylene-manuf.-by-product",90989-43-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b53e58c7-77e2-4f0e-a0cb-c680c33eaf3e/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_00983b96-6504-420c-83f9-558110a38982.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, "Aromatic hydrocarbons, distn. residues, naphthalene-rich",98072-36-7,"Repeated dose toxicity data are not available for Fuel Oils streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene - when present at 10%). The available data on the marker constituent DCPD do not reveal any specific target organ toxicity of a severity that would warrant classification. Therefore, no classification or labelling is warranted for streams which only contain these components. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26b96f67-c542-49cf-9ec2-8821f3020f4d/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_95e867d3-1155-4c66-bc10-fb713a47b408.html,,,,,, "Aromatic hydrocarbons, distn. residues, naphthalene-rich",98072-36-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26b96f67-c542-49cf-9ec2-8821f3020f4d/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_95e867d3-1155-4c66-bc10-fb713a47b408.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Aromatic hydrocarbons, distn. residues, naphthalene-rich",98072-36-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26b96f67-c542-49cf-9ec2-8821f3020f4d/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_95e867d3-1155-4c66-bc10-fb713a47b408.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Aromatic hydrocarbons, distn. residues, naphthalene-rich",98072-36-7,"Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen.The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene.   Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene.   Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene. Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26b96f67-c542-49cf-9ec2-8821f3020f4d/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_95e867d3-1155-4c66-bc10-fb713a47b408.html,,,,,, "Aromatic hydrocarbons, distn. residues, naphthalene-rich",98072-36-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26b96f67-c542-49cf-9ec2-8821f3020f4d/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_95e867d3-1155-4c66-bc10-fb713a47b408.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aromatic hydrocarbons, distn. residues, naphthalene-rich",98072-36-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26b96f67-c542-49cf-9ec2-8821f3020f4d/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_95e867d3-1155-4c66-bc10-fb713a47b408.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Aromatic hydrocarbons, distn. residues, naphthalene-rich",98072-36-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26b96f67-c542-49cf-9ec2-8821f3020f4d/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_95e867d3-1155-4c66-bc10-fb713a47b408.html,,inhalation,LC50,"1,600 mg/m3",no adverse effect observed, Arsine,7784-42-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e48ccd8e-f155-488d-9b8c-7cee5c40b8e0/documents/0b3a9c99-7be3-4745-a749-49cfa7a77586_85a1bed3-c1e1-4f9d-9d99-ebefebc99bdc.html,,inhalation,LC50,143.6 mg/m3,adverse effect observed, "Ashes (residues), cenospheres",93924-19-7," Based on read-across following an analogue approach: Oral: OECD 407; GLP; Wistar rat (male/female); 250, 500, and 1000 mg/kg bw/day; NOAEL 1000 mg/kg bw/day Dermal: No dermal repeated dose toxicity studies available. Inhalation: No guideline; non-GLP; rat; NOAEC systemic: 4.2 mg/m³ for rats (subchronic exposure to 100% respirable particles); 280 mg/m³ based on total ashes (residues), cenospheres containing < 1.5% respirable particles LOEC/NOAEC local: 4.2 mg/m³ for rats (subchronic exposure to 100% respirable particles); 280 mg/m³ based on total ashes (residues), cenospheres containing < 1.5% respirable particles NOAEC local: 30 mg/m³ for rats (subacute exposure to 100% respirable particles); 2000 mg/m³ based on total ashes (residues), cenospheres containing < 1.5% respirable particles ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7deffa1c-c1ae-44a7-a060-d38a6fb8e3eb/documents/IUC5-b6a8c1e7-53fb-4c11-a720-b546e0a3e07b_f37c1ea6-7ae6-4b9e-bd54-c2870beb3563.html,,,,,, "Ashes (residues), cenospheres",93924-19-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7deffa1c-c1ae-44a7-a060-d38a6fb8e3eb/documents/IUC5-b6a8c1e7-53fb-4c11-a720-b546e0a3e07b_f37c1ea6-7ae6-4b9e-bd54-c2870beb3563.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Ashes (residues), cenospheres",93924-19-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7deffa1c-c1ae-44a7-a060-d38a6fb8e3eb/documents/IUC5-b6a8c1e7-53fb-4c11-a720-b546e0a3e07b_f37c1ea6-7ae6-4b9e-bd54-c2870beb3563.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,4.2 mg/m3,,rat "Ashes (residues), cenospheres",93924-19-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7deffa1c-c1ae-44a7-a060-d38a6fb8e3eb/documents/IUC5-b6a8c1e7-53fb-4c11-a720-b546e0a3e07b_f37c1ea6-7ae6-4b9e-bd54-c2870beb3563.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4.2 mg/m3,no adverse effect observed,rat "Ashes (residues), cenospheres",93924-19-7," Based on read-across following an analogue approach: Oral: LD50 (rat) > 2000 mg/kg bw Inhalation: LC50 (rat) > 1400 mg/m³ (respirable fraction), > 5000 mg/m³ (total ashes (residues), cenospheres) Dermal: no study available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7deffa1c-c1ae-44a7-a060-d38a6fb8e3eb/documents/IUC5-1f5adc77-d61a-4196-a2fd-c85fa8ea4c17_f37c1ea6-7ae6-4b9e-bd54-c2870beb3563.html,,,,,, "Ashes (residues), plant",93333-79-0,"Repeated oral dose toxicity was performed in accordance with the method:Method B.26 Sub-Chronic Oral Toxicity Test: Repeated Dose 90-day Oral Toxicity Study in Rodents, Council Regulation (EC) No. 440/2008, Published in O.J. L142, 2008GLP study ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0962499-3121-4ec7-9cab-e9e667b4b5f4/documents/IUC5-318d6771-f305-47f8-a62f-8e8b5e3d1e33_27735436-7683-4fef-a1f8-c0a4c940a7db.html,,,,,, "Ashes (residues), plant",93333-79-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0962499-3121-4ec7-9cab-e9e667b4b5f4/documents/IUC5-318d6771-f305-47f8-a62f-8e8b5e3d1e33_27735436-7683-4fef-a1f8-c0a4c940a7db.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat "Ashes (residues), plant",93333-79-0,"The tests were performed according to the following methods: Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008.Method B.3 Acute Toxicity (Dermal), Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008Both: GLP studyNo data for acute inhalation toxicity are available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0962499-3121-4ec7-9cab-e9e667b4b5f4/documents/IUC5-b707f85a-5d0a-42a5-ab94-6b396626d0e3_27735436-7683-4fef-a1f8-c0a4c940a7db.html,,,,,, "Ashes (residues), plant",93333-79-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0962499-3121-4ec7-9cab-e9e667b4b5f4/documents/IUC5-b707f85a-5d0a-42a5-ab94-6b396626d0e3_27735436-7683-4fef-a1f8-c0a4c940a7db.html,,oral,LD50,"2,000 mg/kg bw",, "Ashes (residues), plant",93333-79-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0962499-3121-4ec7-9cab-e9e667b4b5f4/documents/IUC5-b707f85a-5d0a-42a5-ab94-6b396626d0e3_27735436-7683-4fef-a1f8-c0a4c940a7db.html,,dermal,LD50,"2,000 mg/kg bw",, "Ashes (residues), rice husk",71630-92-7,"No studies via oral or dermal exposure are available for rice husk ashes, and limited or no data are available on crystalline silica for the same exposure routes. Toxicokinetic data of crystalline silica suggest minimal absorption and bioavailabity upon oral exposure and virtually no absorption via the dermal route.Lung inflammation, cellular proliferation and ultimately fibrosis are the main toxic effects most likely to occur after repeated short- and long-term exposure to respirable crystalline silica particles (MMAD < 5 µm). Animal dose-response data for crystalline silica are limited. The lowest published toxic concentration for chronic (two-year intermittent) inhalation exposure in rats was 0.74 mg/m3. However, human data indicate a significant risk of developing chronic silicosis at exposure levels as low as 0.05 mg/m³ in occupational settings. Therefore, 0.05 mg/m³ is regarded as the LOAEC for respirable crystalline silica. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b40cfd6-d617-4200-a5a8-2aeb96589bfd/documents/IUC5-abfa5d01-2505-4b87-9ff5-ea4c9198f519_4c3d2478-4f3d-4ef2-86c1-05677f68d8eb.html,,,,,, "Ashes (residues), rice husk",71630-92-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b40cfd6-d617-4200-a5a8-2aeb96589bfd/documents/IUC5-abfa5d01-2505-4b87-9ff5-ea4c9198f519_4c3d2478-4f3d-4ef2-86c1-05677f68d8eb.html,Chronic toxicity – systemic effects,inhalation,LOAEC,0.05 mg/m3,, "Ashes (residues), rice husk",71630-92-7,"No information on the acute toxicity of rice husk ashes via oral, dermal or inhalative route is available. The crystalline polymorph of silica is the toxicologically relevant component of rice husk ashes. Limited or not useful data are available on lethal doses of crystalline silica in experimental animals. In humans, acute oral and dermal exposure to crystalline silica may not lead to systemic toxic effects (probable oral LD50 > 15000 mg/kg bw) (WHO, 1974), based on its physicochemical and toxicokinetic properties. Acute silicosis occurs after acute exposures to high concentrations of respirable crystalline silica particles.A single dose of ca. 277-333 mg rice husk ashes/kg bw intratracheally applied to rats was not lethal, but caused caused diffuse interstitial fibrosis and nodules after 12 months. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b40cfd6-d617-4200-a5a8-2aeb96589bfd/documents/IUC5-454b0319-84f5-4f70-b23c-cdf386ccc1dd_4c3d2478-4f3d-4ef2-86c1-05677f68d8eb.html,,,,,, "Ashes (residues), rice husk",71630-92-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b40cfd6-d617-4200-a5a8-2aeb96589bfd/documents/IUC5-454b0319-84f5-4f70-b23c-cdf386ccc1dd_4c3d2478-4f3d-4ef2-86c1-05677f68d8eb.html,,oral,LD50,"3,160 mg/kg bw",, "Ashes (residues), vanadium-contg.",84144-87-6,Acute oral toxicity was assessed in an acute toxic class method according to OECD 423 (BSL 2010a) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e88e9e2-1fb9-4cc7-9404-a0f221578a02/documents/IUC5-bd70ee88-0019-4f14-98ce-3467072d3183_bccada7a-8e8a-411f-85b3-f0093bf1aacf.html,,,,,, "Ashes (residues), vanadium-contg.",84144-87-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e88e9e2-1fb9-4cc7-9404-a0f221578a02/documents/IUC5-bd70ee88-0019-4f14-98ce-3467072d3183_bccada7a-8e8a-411f-85b3-f0093bf1aacf.html,,oral,LD50,500 mg/kg bw,, diethyl N-[3-(trimethoxysilyl)propyl]aspartate,192389-48-3,LD50 oral (rat): ≥ 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5bc11f3-d88f-49ed-b85a-c8074269f489/documents/3b46d6c4-aa19-4419-acf3-d65780249ab3_ac7cfc5f-c36a-47d7-828d-46b1e193932b.html,,,,,, diethyl N-[3-(trimethoxysilyl)propyl]aspartate,192389-48-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5bc11f3-d88f-49ed-b85a-c8074269f489/documents/3b46d6c4-aa19-4419-acf3-d65780249ab3_ac7cfc5f-c36a-47d7-828d-46b1e193932b.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Asphalt,8052-42-4," The following studies were identified: two read-across 28-day dermal studies (OECD 410); a 90-day inhalation study; and a read across chronic inhalation study (OECD 451). In addition a supporting inhalation study is available ( 14 days). In a combined repeat dose / reproductive screening study with oxidized asphalt, no significant effects were observed For the dermal studies performed on rabbits, the LOAEL topical effects for both samples of vacuum residue was 200 mg/kg/day and the NOAEL for systemic effects was >2000 mg/kg; both endpoints were based on absence of significant histopathological findings. For the 90-day inhalation study the NOAEL was 20.1 mg/m³ (28.2 mg/m³ adjusted) based on local effects in the upper respiratory tract. In  the chronic inhalation study, the NOAEL for systemic effects in the rat following inhalation was >103.9 mg/m3 (172.5 mg/m3 adjusted) based on the absence of any significant histopathological changes or alterations in haematology. The LOEC for local effects was 20.7 mg/m³ (34.4 mg/m³ adjusted), based on irritant effects on the nasal passages.  A conservative estimate of the NOAEC was set at half the LOAEC, that is 10.4 mg/m³ total hydrocarbon concentration (17.2 mg/m³ adjusted) based on the minimal effects and the fact that in the 90-day study a NOAEC of 20.1 mg/m³ (28.2 mg/m³ adjusted) was found. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a56ac02-36c5-409d-ad8d-275d69bb26a8/documents/cfb925c3-4d76-4dc9-acaa-e3300d521425_a16ebe32-44c3-4d66-a6fc-7fc2c03c515f.html,,,,,, Asphalt,8052-42-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a56ac02-36c5-409d-ad8d-275d69bb26a8/documents/cfb925c3-4d76-4dc9-acaa-e3300d521425_a16ebe32-44c3-4d66-a6fc-7fc2c03c515f.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rabbit Asphalt,8052-42-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a56ac02-36c5-409d-ad8d-275d69bb26a8/documents/cfb925c3-4d76-4dc9-acaa-e3300d521425_a16ebe32-44c3-4d66-a6fc-7fc2c03c515f.html,Chronic toxicity – systemic effects,inhalation,NOAEC,172.5 mg/m3,,rat Asphalt,8052-42-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a56ac02-36c5-409d-ad8d-275d69bb26a8/documents/cfb925c3-4d76-4dc9-acaa-e3300d521425_a16ebe32-44c3-4d66-a6fc-7fc2c03c515f.html,Repeated dose toxicity – local effects,dermal,LOAEL,1.9 mg/cm2,adverse effect observed,rabbit Asphalt,8052-42-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a56ac02-36c5-409d-ad8d-275d69bb26a8/documents/cfb925c3-4d76-4dc9-acaa-e3300d521425_a16ebe32-44c3-4d66-a6fc-7fc2c03c515f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,17.2 mg/m3,adverse effect observed,rat Asphalt,8052-42-4,"Key acute oral (OECD 401), dermal (OECD 402), and inhalation (OECD 403) studies were identified.• The oral LD50 was > 5000 mg/kg bw in male and female rats for two petroleum vacuum residues.• The dermal LD50 was > 2000 mg/kg bw in male and female rabbits for two petroleum vacuum residues.• The LC50 was > 94.4 mg/m3 in male and female rats for fumes from oxidized (air-rectified) asphalt. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a56ac02-36c5-409d-ad8d-275d69bb26a8/documents/e690a326-d489-4230-962e-68962f5ed2e6_a16ebe32-44c3-4d66-a6fc-7fc2c03c515f.html,,,,,, Asphalt,8052-42-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a56ac02-36c5-409d-ad8d-275d69bb26a8/documents/e690a326-d489-4230-962e-68962f5ed2e6_a16ebe32-44c3-4d66-a6fc-7fc2c03c515f.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Asphalt,8052-42-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a56ac02-36c5-409d-ad8d-275d69bb26a8/documents/e690a326-d489-4230-962e-68962f5ed2e6_a16ebe32-44c3-4d66-a6fc-7fc2c03c515f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Asphalt,8052-42-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a56ac02-36c5-409d-ad8d-275d69bb26a8/documents/e690a326-d489-4230-962e-68962f5ed2e6_a16ebe32-44c3-4d66-a6fc-7fc2c03c515f.html,,inhalation,LC50,94.4 mg/m3,no adverse effect observed, "Asphalt, oxidized",64742-93-4," The following studies were identified: two read-across 28-day dermal studies (OECD 410); a 90-day inhalation study; and a read across chronic inhalation study (OECD 451). In addition a supporting inhalation study is available ( 14 days). In a combined repeat dose / reproductive screening study with oxidized asphalt, no significant effects were observed For the dermal studies performed on rabbits, the LOAEL topical effects for both samples of vacuum residue was 200 mg/kg/day and the NOAEL for systemic effects was >2000 mg/kg; both endpoints were based on absence of significant histopathological findings. For the 90-day inhalation study the NOAEL was 20.1 mg/m³ (28.2 mg/m³ adjusted) based on local effects in the upper respiratory tract. In  the chronic inhalation study, the NOAEL for systemic effects in the rat following inhalation was >103.9 mg/m3 (172.5 mg/m3 adjusted) based on the absence of any significant histopathological changes or alterations in haematology. The LOEC for local effects was 20.7 mg/m³ (34.4 mg/m³ adjusted), based on irritant effects on the nasal passages.  A conservative estimate of the NOAEC was set at half the LOAEC, that is 10.4 mg/m³ total hydrocarbon concentration (17.2 mg/m³ adjusted) based on the minimal effects and the fact that in the 90-day study a NOAEC of 20.1 mg/m³ (28.2 mg/m³ adjusted) was found. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73ff02ba-014c-41b5-9376-c49f67d0c1fa/documents/995f7f8a-4b6d-484f-8563-ad899885e827_f21b9088-35c5-4679-8923-4257ec8767e5.html,,,,,, "Asphalt, oxidized",64742-93-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73ff02ba-014c-41b5-9376-c49f67d0c1fa/documents/995f7f8a-4b6d-484f-8563-ad899885e827_f21b9088-35c5-4679-8923-4257ec8767e5.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rabbit "Asphalt, oxidized",64742-93-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73ff02ba-014c-41b5-9376-c49f67d0c1fa/documents/995f7f8a-4b6d-484f-8563-ad899885e827_f21b9088-35c5-4679-8923-4257ec8767e5.html,Chronic toxicity – systemic effects,inhalation,NOAEC,172.5 mg/m3,,rat "Asphalt, oxidized",64742-93-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73ff02ba-014c-41b5-9376-c49f67d0c1fa/documents/995f7f8a-4b6d-484f-8563-ad899885e827_f21b9088-35c5-4679-8923-4257ec8767e5.html,Repeated dose toxicity – local effects,dermal,LOAEL,1.9 mg/cm2,adverse effect observed,rabbit "Asphalt, oxidized",64742-93-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73ff02ba-014c-41b5-9376-c49f67d0c1fa/documents/995f7f8a-4b6d-484f-8563-ad899885e827_f21b9088-35c5-4679-8923-4257ec8767e5.html,Repeated dose toxicity – local effects,inhalation,NOAEC,17.2 mg/m3,adverse effect observed,rat "Asphalt, oxidized",64742-93-4,"Key acute oral (OECD 401), dermal (OECD 402), and inhalation (OECD 403) studies were identified.• The oral LD50 was > 5000 mg/kg bw in male and female rats for two petroleum vacuum residues.• The dermal LD50 was > 2000 mg/kg bw in male and female rabbits for two petroleum vacuum residues.• The LC50 was > 94.4 mg/m3 in male and female rats for fumes from air-rectified (partially oxidized) asphalt. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73ff02ba-014c-41b5-9376-c49f67d0c1fa/documents/a11c6b56-e644-476c-a34d-30eea705d13b_f21b9088-35c5-4679-8923-4257ec8767e5.html,,,,,, "Asphalt, oxidized",64742-93-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73ff02ba-014c-41b5-9376-c49f67d0c1fa/documents/a11c6b56-e644-476c-a34d-30eea705d13b_f21b9088-35c5-4679-8923-4257ec8767e5.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Asphalt, oxidized",64742-93-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73ff02ba-014c-41b5-9376-c49f67d0c1fa/documents/a11c6b56-e644-476c-a34d-30eea705d13b_f21b9088-35c5-4679-8923-4257ec8767e5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Asphalt, oxidized",64742-93-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73ff02ba-014c-41b5-9376-c49f67d0c1fa/documents/a11c6b56-e644-476c-a34d-30eea705d13b_f21b9088-35c5-4679-8923-4257ec8767e5.html,,inhalation,LC50,94.4 mg/m3,no adverse effect observed, "Asphalt, sulfonated, sodium salt",68201-32-1," In a study conducted according to OECD Test guideline 408 and in compliance with GLP (Charles River Laboratories, 2021), Wistar Han rats were administered Asphalt, Sulfonated, Sodium Salt (SAS) at 0, 100, 300 and 1000 mg/kg bw/day by oral gavage (water vehicle) for 7 days a week for at least 90 days. A NOAEL of 1000 mg/kg bw/day was identified based on no effects in males and females. In males, minimal to moderate statistically significant dose-related observations were seen at all doses (decreased eosinophils) and non-statistically significant decreases to lymphocytes at all doses (resulting in slightly lowered total white blood cell counts) were reported. In females, non-statistically significant decreases to eosinophils at all doses were also recorded. These effects remained after the period of recovery in both males and females. However, the effects were not considered to be adverse due to a lack of corroborative histopathological finding (in the spleen, for example) and/or the mean values remained within the range considered normal for rats of this age and strain (historical control data). Taken together, these observations were considered a chance finding. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/121e0a14-a564-4d68-b0e7-80d638854555/documents/IUC5-64ecf449-e493-4f71-9071-cc9b16141925_2b7d59cb-98ca-407d-aad2-7eafc87275f5.html,,,,,, "Asphalt, sulfonated, sodium salt",68201-32-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/121e0a14-a564-4d68-b0e7-80d638854555/documents/IUC5-64ecf449-e493-4f71-9071-cc9b16141925_2b7d59cb-98ca-407d-aad2-7eafc87275f5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Asphalt, sulfonated, sodium salt",68201-32-1," ACUTE ORAL TOXICITY: SAS has been tested for acute toxicity via the oral route and exhibits a low order of toxicity. Two acute studies on two separate commercial products containing approximately 85% SAS have been conducted according to the Environmental Protection Agency requirements, 40 CFR 158-135. The LD50 for these two commercial products was estimated to be greater than 5000 mg/kg of body weight (equivalent to 4,250 mg SAS/kg bw) in both male and female rats. ACUTE DERMAL TOXICITY: Acute dermal toxicity studies were not available for SAS.   ACUTE INHALATION TOXICITY: SAS has been tested for acute toxicity via the inhalation route. In the key acute inhalation toxicity study, conducted according to OECD TG 403 and in compliance with GLP, the reported LC50 value was greater than 5.3 mg/L air (WIL, 2014). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/121e0a14-a564-4d68-b0e7-80d638854555/documents/IUC5-fae0e5db-598b-416f-bc93-44c61d34a6de_2b7d59cb-98ca-407d-aad2-7eafc87275f5.html,,,,,, "Asphalt, sulfonated, sodium salt",68201-32-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/121e0a14-a564-4d68-b0e7-80d638854555/documents/IUC5-fae0e5db-598b-416f-bc93-44c61d34a6de_2b7d59cb-98ca-407d-aad2-7eafc87275f5.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Asphalt, sulfonated, sodium salt",68201-32-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/121e0a14-a564-4d68-b0e7-80d638854555/documents/IUC5-fae0e5db-598b-416f-bc93-44c61d34a6de_2b7d59cb-98ca-407d-aad2-7eafc87275f5.html,,inhalation,LC50,"5,300 mg/m3",no adverse effect observed, "Avermectin A(sub 1a), 25-cyclohexyl-5-O-demethyl-25-de(1-methylpropyl)-",117704-25-3,"Oral: Two 90-day studies are available. Rat study: No treatment related gross or histological findings except for an increase in absolute and relative liver weights for the high dose females. The no-observed-effect-level (NOEL) for this study is 2.0 mg/kg/day (Fisher, 1990). Dog study: The only significant clinical finding was that of mydriasis in 1 of 6 high dose animals. There was no effect of treatment on body weights, vital signs, serum chemistry, hematology or urinalysis values. The no-observed-effect-level (NOEL) in beagle dogs is 0.1 mg/kg (Stadnicki, 1990). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/59834655-7844-4727-af53-de1b06ae2994/documents/IUC5-9c0bb065-cab5-4f6d-aa50-ecc0cf7eb5a9_772bb8bf-a514-4807-8ff1-c3ebf3717902.html,,,,,, "Avermectin A(sub 1a), 25-cyclohexyl-5-O-demethyl-25-de(1-methylpropyl)-",117704-25-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/59834655-7844-4727-af53-de1b06ae2994/documents/IUC5-9c0bb065-cab5-4f6d-aa50-ecc0cf7eb5a9_772bb8bf-a514-4807-8ff1-c3ebf3717902.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.3 mg/kg bw/day,,dog "Avermectin A(sub 1a), 25-cyclohexyl-5-O-demethyl-25-de(1-methylpropyl)-",117704-25-3,"Oral: Two studies on rats and mice are available. One study performed with aqueous methylcellulose solution, LD50 in female rat was in the range of 500-1000 mg/kg bw and in male was 1000-2000 mg/kg bw; LD50 in female and male mice were greater than 2000 mg/kg bw (Stadnicki, 1988). Another study performed with sesame oil, LD50 in female rat was in the range of 100-200 mg/kg bw and in male was 50-100 mg/kg bw; LD50 in female and male mice were 250-500 mg/kg bw (Nancy, 1992).   Dermal: One study on rats is available. LD50 in male and female albino rats was greater than 2000 mg/kg (Weinberg, 2015).   Inhalation: The LC50 of the test substance was 0.54 mg/L when male and female Crl:CD(SD) rats were exposed to a dust aerosol of the test substance as a single, 4-hour, nose-only exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59834655-7844-4727-af53-de1b06ae2994/documents/IUC5-78aebc24-d57e-48a9-8754-181c82c2e303_772bb8bf-a514-4807-8ff1-c3ebf3717902.html,,,,,, "Avermectin A(sub 1a), 25-cyclohexyl-5-O-demethyl-25-de(1-methylpropyl)-",117704-25-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59834655-7844-4727-af53-de1b06ae2994/documents/IUC5-78aebc24-d57e-48a9-8754-181c82c2e303_772bb8bf-a514-4807-8ff1-c3ebf3717902.html,,oral,LD50,> 50 mg/kg bw,adverse effect observed, "Avermectin A(sub 1a), 25-cyclohexyl-5-O-demethyl-25-de(1-methylpropyl)-",117704-25-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59834655-7844-4727-af53-de1b06ae2994/documents/IUC5-78aebc24-d57e-48a9-8754-181c82c2e303_772bb8bf-a514-4807-8ff1-c3ebf3717902.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Avermectin A(sub 1a), 25-cyclohexyl-5-O-demethyl-25-de(1-methylpropyl)-",117704-25-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59834655-7844-4727-af53-de1b06ae2994/documents/IUC5-78aebc24-d57e-48a9-8754-181c82c2e303_772bb8bf-a514-4807-8ff1-c3ebf3717902.html,,inhalation,LC50,0.54 mg/L,adverse effect observed, "Azelaic acid, calcium salt (1:1)",14488-58-5," Data have been read across from the structural analogues, dilithium azelate, azelaic acid and calcium. Although effects were observed in the acute oral toxicity study with dilithium azelate, these effects were a result of the concentration of lithium present, and do not correlate with the expected toxicity effects of calcium azelate. This conclusion is supported by the LD50 values for azelaic acid (>5,000 mg/kg bw) and calcium (930 mg/kg bw, equivalent to 5258 mg/kg calcium azelate), which shows the calcium azelate would not meet the criteria for classification for acute oral toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c23121a-bbfe-43c7-964f-5817a951cd9b/documents/fc348f72-e8c7-485d-b90a-bf6a0110226e_d609848e-b7fc-4fad-aac2-f09ccd5b62e2.html,,,,,, azido(trioctyl)stannane,154704-56-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e1d2aa9-9f7f-4ff1-8bc3-3cb3fe7959f3/documents/e30f0689-6bd5-4bc1-9f25-a7e830740b1f_8f61e97a-06ec-4c2b-b698-731297da29ec.html,,oral,LD50,50 mg/kg bw,adverse effect observed, Barbital sodium,144-02-5," Eight studies with repeated oral administration of sodium barbital exist: seven studies with sufficient reliability and one not reliable study. No study with inhalative or dermal exposure is available. Effects of sodium barbital on male rats and mice were examined in 12 -day to 64-week studies. Increases in liver-to-body weight ratios and increased levels of cell proliferation/ elevated levels of DNA synthesis in renal tubular cells were observed . Sodium barbital had no effect on hepatic metallothionein concentrations in male mice. Livers of male mice fed sodium barbital showed centrilobular hepatocytomegaly. Due to missing information on histologic or clinical pathology alterations indicative of liver toxicity, it cannot be finally clarified whether hepatocytomegaly in this case was an adaptive/non-adverse reaction or an adverse reaction. Impairment of functional capacity or impairment of capacity to compensate for additional stress or increase in susceptibility to other environmental influences was not described. Females were either not examined or did not show such effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d1f3495b-4e17-48de-85cb-e47a7aa7311d/documents/93f846b0-9fe4-43cc-97bc-5626f9f07d9e_ea010ced-1474-4fc2-949d-dc7688c48dfc.html,,,,,, Barbital sodium,144-02-5," There is one study with sufficient reliability with oral administration in rats. Acute toxicity oral in rat was reported as LD50 600 mg/kg bw. According to this result a classification for acute toxicity oral in Category 4 based on GHS criteria is recommended. Further one study with oral administration, two studies with intraperitoneal administration, two studies with intravenous administration and four subcutaneous administration have no sufficient reliability and are therefore ignored. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1f3495b-4e17-48de-85cb-e47a7aa7311d/documents/42230608-7a44-4643-b385-3ea5b107e220_ea010ced-1474-4fc2-949d-dc7688c48dfc.html,,,,,, Barbital sodium,144-02-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1f3495b-4e17-48de-85cb-e47a7aa7311d/documents/42230608-7a44-4643-b385-3ea5b107e220_ea010ced-1474-4fc2-949d-dc7688c48dfc.html,,oral,LD50,600 mg/kg bw,adverse effect observed, Barbituric acid,67-52-7," Male and Female rats were subjected to test acute oral toxicity according to OECD TG 401. The test item was administered at dose levels of 1 000 and 5 000 mg/kg bw to 5 male and 5 female rats respectively. During the 14 days observation period no animals died and there were no abnormalities found in necropsy, thus leading to an LD50 > 5 000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ba46668-2b69-4afe-820a-abf9112adc76/documents/47299309-7429-40d4-941a-f57366e21418_458ea0a6-343a-40cc-a213-3657579db54b.html,,,,,, Barbituric acid,67-52-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ba46668-2b69-4afe-820a-abf9112adc76/documents/47299309-7429-40d4-941a-f57366e21418_458ea0a6-343a-40cc-a213-3657579db54b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Barium,7440-39-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6df431bd-9506-4658-b55f-5378e0075a5f/documents/a5486991-fecf-4027-8180-9516831a4235_e791a567-1171-4e27-a300-6a1fd09d716e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,91 mg/kg bw/day,,rat Barium,7440-39-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6df431bd-9506-4658-b55f-5378e0075a5f/documents/c0491dcb-e236-4057-b7b5-0616f46dda6a_e791a567-1171-4e27-a300-6a1fd09d716e.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Barium 3,5,5-trimethylhexanoate",36211-43-5," No repeated dose toxicity study with barium bis(3,5,5-trimethylhexanoate) is available, thus the repeated dose toxicity will be addressed with existing data on the assessment entities barium and 3,5,5 -trimethylhexanoic acid. According to the RAAF, neodecanoic acid will be considered as representative of 3,5,5-trimethylhexanoic acid. In relevant and reliable repeated dose toxicity studies as well as supporting studies for both assessment entities of barium bis(3,5,5-trimethylhexanoate), there were no toxicological findings reported that would justify a classification. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82ac3e45-aac0-446d-84d5-ad48f3917da2/documents/b534ffb4-8f28-450e-9ba9-cb983bace4ae_f5f61126-930e-474f-9020-1057f0ec294f.html,,,,,, "Barium 3,5,5-trimethylhexanoate",36211-43-5," No acute toxicity studies with barium bis(3,5,5-trimethylhexanoate) are available, thus the acute toxicity will be addressed with existing data on the dissociation products barium and 3,5,5-trimethylhexanoic acid. According to the read-across assessment framework (RAAF), neodecanoic acid will be considered in place of 3,5,5-trimethylhexanoic acid. Three studies with the assessment entity barium are available and used in a weight of evidence approach resulting in a LD50>100 and <300 mg/kg bw. Barium salts ((EC) No 1272/2008; Index No. 056-002-00-7) are legally binding classified for acute toxicity (oral and inhalation toxicity) category 4. A dermal study with barium dichloride, showed a LD50 value of greater than 2000 mg/kg bw. Neodecanoic acid, as representative of 3,5,5-trimethylhexanoic acid, has not shown signs of acute oral or acute dermal toxicity in experimental testing (LD50 > 2000mg/kg). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82ac3e45-aac0-446d-84d5-ad48f3917da2/documents/63b35bad-48e4-4b65-84df-4686a5de81eb_f5f61126-930e-474f-9020-1057f0ec294f.html,,,,,, Barium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,17852-98-1,"The NOEL for chronic oral toxicity is established at 25 mg/kg bw based on repeated dose toxicity studies with analogue substances. Higher doses result in kidney damage. This is derived from subacute gavage studies with Pigment Red 57:1 (OECD 422, GLP, MHLW 1993), Pigment Red 48:2 (OECD 422, GLP, MHLW 2009) and Pigment Red 57-Sr (OECD 407, GLP, DIC 2006). In a chronic feeding study with the sodium salt of Pigment Red 57, exacerbation of spontaneous renal disease in aged rats was observed with a NOEL of 0.05 % (CTFA 1981a). The dietary concentration of 0.05% corresponds to an average dose of 26 mg/kg bw for males and 31 mg/kg bw for females. A NOEL of 25 mg/kg bw was identified in a two-year feeding study in rats with Pigment Red 53:1. A NOEL of 30 mg/kg bw for rats and mice was identified for Barium as applied in Barium chloride dihydrate in drinking water for two years.No histopathology findings on kidneys were reported after a two-year skin painting study with mice with Pigment Red 57:1 (Carson 1984). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3af6a5c-14ad-485c-98d9-8e032ac9e6cb/documents/3f829f1a-c855-4d50-84f5-b7616f422471_25c29ff9-be67-4734-8137-63e3bceea0c5.html,,,,,, Barium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,17852-98-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3af6a5c-14ad-485c-98d9-8e032ac9e6cb/documents/3f829f1a-c855-4d50-84f5-b7616f422471_25c29ff9-be67-4734-8137-63e3bceea0c5.html,Chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Barium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,17852-98-1,"Experimental data is available for the analogue Pigment Red 48:1 (7585-41-3) which differs from Pigment Red 57:2 by one additional chlorine at the sulfonic aromatic amine part. It is concluded that Pigment Red 57:2 is of low acute toxicity after oral, dermal or inhalation toxicity.Pigment Red 48:1 caused no mortality and no signs of intoxication at doses between 5000 and 10000 mg/kg bw in rats after single gavage application and an observation period of seven or eight days (Ciba 1972, BASF AG 1974a). No mortality and no indication of systemic toxicity was observed in rats after single dermal application of a dose of 2500 mg/kg bw Pigment Red 48:1 (BASF AG 1974b). The study was performed following a procedure comparable to OECD testing guideline 402.Acute inhalation exposure to aerosol at a concentration of 4.76 mg/L (MMAD 1.4 μm / GSD 0.34) caused mortality in one of ten rats (Capelle 1993) as assessed in a GLP compliant study following OECD testing guideline 403. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3af6a5c-14ad-485c-98d9-8e032ac9e6cb/documents/f3840487-c311-4de3-a0a2-0eb1e2d771a2_25c29ff9-be67-4734-8137-63e3bceea0c5.html,,,,,, Barium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,17852-98-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3af6a5c-14ad-485c-98d9-8e032ac9e6cb/documents/f3840487-c311-4de3-a0a2-0eb1e2d771a2_25c29ff9-be67-4734-8137-63e3bceea0c5.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Barium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,17852-98-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3af6a5c-14ad-485c-98d9-8e032ac9e6cb/documents/f3840487-c311-4de3-a0a2-0eb1e2d771a2_25c29ff9-be67-4734-8137-63e3bceea0c5.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, Barium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate,7585-41-3," The NOAEL for chronic oral toxicity is established at 25 mg/kg bw based on repeated dose toxicity studies with analogue substances. Higher doses result in kidney damage. This is derived from subacute gavage studies with Pigment Red 57:1(Ca) (OECD 422, GLP, MHLW 1993), Pigment Red 48:2(Ca) (OECD 422, GLP, MHLW 2009) and Pigment Red 57(Sr) (OECD 407, GLP, DIC 2006). No histopathology findings on kidneys were reported after a two-year skin painting study with mice with Pigment Red 57:1(Ca) (Carson 1984). Regarding the cation, available data indicate that the data available for the Pigments covers the hazard of both the related anion and cation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac0b09b2-7d10-4aa6-b845-89ff416aa0dc/documents/IUC5-139e5c68-020c-45d0-bdf5-0c1a9ae4ccb0_2bef3eb8-c008-4a47-bb30-a9e25d35145b.html,,,,,, Barium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate,7585-41-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac0b09b2-7d10-4aa6-b845-89ff416aa0dc/documents/IUC5-139e5c68-020c-45d0-bdf5-0c1a9ae4ccb0_2bef3eb8-c008-4a47-bb30-a9e25d35145b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Barium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate,7585-41-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac0b09b2-7d10-4aa6-b845-89ff416aa0dc/documents/IUC5-139e5c68-020c-45d0-bdf5-0c1a9ae4ccb0_2bef3eb8-c008-4a47-bb30-a9e25d35145b.html,Chronic toxicity – systemic effects,dermal,NOAEL,50 mg/kg bw/day,,mouse Barium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate,7585-41-3," Studies investigating oral, inhalation, and dermal acute toxicity are available. Oral LD50 >6400 mg/kg bw Inhalation LD50 >4760 mg/m3 Dermal LD50 >2500 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac0b09b2-7d10-4aa6-b845-89ff416aa0dc/documents/IUC5-1e5c4c27-3a59-4859-a871-16616adc1364_2bef3eb8-c008-4a47-bb30-a9e25d35145b.html,,,,,, Barium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate,7585-41-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac0b09b2-7d10-4aa6-b845-89ff416aa0dc/documents/IUC5-1e5c4c27-3a59-4859-a871-16616adc1364_2bef3eb8-c008-4a47-bb30-a9e25d35145b.html,,oral,LD50,"6,400 mg/kg bw",no adverse effect observed, Barium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate,7585-41-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac0b09b2-7d10-4aa6-b845-89ff416aa0dc/documents/IUC5-1e5c4c27-3a59-4859-a871-16616adc1364_2bef3eb8-c008-4a47-bb30-a9e25d35145b.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, Barium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate,7585-41-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac0b09b2-7d10-4aa6-b845-89ff416aa0dc/documents/IUC5-1e5c4c27-3a59-4859-a871-16616adc1364_2bef3eb8-c008-4a47-bb30-a9e25d35145b.html,,inhalation,LC50,"4,760 mg/m3",no adverse effect observed, Barium 4-dodecylphenolate,93922-04-4," A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422 (2016); GLP) with Barium 4-dodecylphenolate was conducted in rats. Based on clinical signs caused by the substance and substance-related effects on body weight, food consumption, organ weights (testes, epididymis, prostate and seminal vesicles with coagulating glands), gross pathology (prostate and seminal vesicle with coagulating gland) and histopathology (prostate and seminal vesicles), the no observed adverse effect level (NOAEL) of this study is 200 mg/kg bw/day for males and females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6cf5532d-5bc0-4f70-9fd2-a676bf7f6a94/documents/c6d7e0b9-fb95-4435-975c-c8f0d383c44c_7cbd0799-ff44-4f4f-b5f0-275ee05a137e.html,,,,,, Barium 4-dodecylphenolate,93922-04-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6cf5532d-5bc0-4f70-9fd2-a676bf7f6a94/documents/c6d7e0b9-fb95-4435-975c-c8f0d383c44c_7cbd0799-ff44-4f4f-b5f0-275ee05a137e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Barium 4-dodecylphenolate,93922-04-4, Acute oral toxicity: LD50 value: 300 < LD50 ≤ 2000 mg/ kg bw Acute dermal toxicity: LD50 value: >2959 mg/ kg bw (equivalent to the limit dose of 2000 mg/kg bw after correction for water content (32.4 %)) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6cf5532d-5bc0-4f70-9fd2-a676bf7f6a94/documents/5124c932-9abf-47ee-a0f4-907903d3b48b_7cbd0799-ff44-4f4f-b5f0-275ee05a137e.html,,,,,, Barium bis(2-ethylhexanoate),2457-01-4,"One key study available (according to OECD 423, under GLP) which is reliable without restrictions (RL=1). The overall quality of the database is therefore high. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c7ff37d-52ef-4d73-9f8b-fef05fb6dfba/documents/IUC5-6357666f-003e-4615-b62e-e6fa3abd3775_6a742480-2625-40a7-b69d-aebcb1c27553.html,,,,,, Barium bis(dihydrogenorthophosphate),13466-20-1," No data regarding repeated dose toxicity is available for Barium bis(dihydrogen orthophosphate). Reliable data is available for the structural similar substance barium chloride dihydrate (CAS 10326 -27 -9). Oral, subchronic (RA from CAS 10326 -27 -9; OECD 408; RL2), rat: NOAEL = 110.0 mg/kg bw/day for males and 115.0 mg/kg bw/day for females; LOAEL = 200 mg/kg bw/day for males and 180 mg/kg bw/day for females ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7102df5-0be2-4427-8bb1-c1d7e45477b8/documents/31998409-d086-4778-93df-f9ed724ad440_11426851-a6b8-4983-bed2-769393d10610.html,,,,,, Barium bis(dihydrogenorthophosphate),13466-20-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7102df5-0be2-4427-8bb1-c1d7e45477b8/documents/31998409-d086-4778-93df-f9ed724ad440_11426851-a6b8-4983-bed2-769393d10610.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,110 mg/kg bw/day,,rat Barium bis(dihydrogenorthophosphate),13466-20-1," Oral (OECD 423, RL1), rat: LD50 > 300 < 2000 mg/kg bw, LD50 cut-off = 2000 mg/kg bw Dermal (OECD 402, RL1), rat: LD50 > 2000 mg/kg bw (limit test) Inhalation: no data available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7102df5-0be2-4427-8bb1-c1d7e45477b8/documents/27d2bd17-d897-47aa-a55e-612bb04164c8_11426851-a6b8-4983-bed2-769393d10610.html,,,,,, Barium bis(dihydrogenorthophosphate),13466-20-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7102df5-0be2-4427-8bb1-c1d7e45477b8/documents/27d2bd17-d897-47aa-a55e-612bb04164c8_11426851-a6b8-4983-bed2-769393d10610.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Barium bis(dihydrogenorthophosphate),13466-20-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7102df5-0be2-4427-8bb1-c1d7e45477b8/documents/27d2bd17-d897-47aa-a55e-612bb04164c8_11426851-a6b8-4983-bed2-769393d10610.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Barium bis[2-[(2-hydroxy-1-naphthyl)azo]benzoate],6372-81-2,"RA_PR 53:1_key_401_1993_Hoechst_93.0643: LD50: >2000 mg/kg body weight, no specific target organ toxicityQSAR PR 50.1 acute oral toxicity OECD Toolbox: LD50: 4840 mg/kg body weightQSAR PR 53.1 acute oral toxicity OECD Toolbox: LD50: 6670 mg/kg body weight ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/300f626c-66e0-4ac4-bc23-57cccf3aaf3b/documents/IUC5-755ea7b4-b742-4efd-a432-806a6cb2f764_e69d87f2-5580-487e-9263-899294935fe0.html,,,,,, Barium bis[2-[(2-hydroxy-1-naphthyl)azo]benzoate],6372-81-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/300f626c-66e0-4ac4-bc23-57cccf3aaf3b/documents/IUC5-755ea7b4-b742-4efd-a432-806a6cb2f764_e69d87f2-5580-487e-9263-899294935fe0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Barium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate],1103-38-4," Repeated dose toxicity of the test substance was not examined. Reliable experimental data of an analogue substance are available. Three studies are suitable to provide information on toxicity after repeated dose administration. The subacute toxicity study in rats at dose levels up to 5% (unknown purity) revealed formation of Heinzbodies, changes in hematology and pathological and histopathological changes in splenn and kidney. The 90d study at dose levels up to 10000 ppm which served as range finder for a cancer study confirms the findings of the 28d study. Additionally, congestion of the spleen and hemosiderosis in the liver was observed. A chronic study in mice at dose levels up to 1000 ppm revealed no adverse effects than changes in hematology. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e7a4a8d-8ca4-4c88-8f4d-c5c3723f9597/documents/IUC5-56aa2edb-669d-4eee-8a9d-3379dfcffc25_47c09399-6ca5-44d0-866a-7a9e9247fea9.html,,,,,, Barium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate],1103-38-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e7a4a8d-8ca4-4c88-8f4d-c5c3723f9597/documents/IUC5-56aa2edb-669d-4eee-8a9d-3379dfcffc25_47c09399-6ca5-44d0-866a-7a9e9247fea9.html,Chronic toxicity – systemic effects,oral,NOAEL,147.3 mg/kg bw/day,,mouse Barium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate],1103-38-4," Studies on inhalative acute toxicity of the test item were not performed. The studies that were performed to evaluate acute oral and inhalative toxicity of the test substance to the rat accorded to OECD guidelines 401 and 403. The test substance did not induce mortalities, abnormalities or clinical signs when applied oral. Also, single administration of the analogue substance via the respiratory system did not cause health effects or mortalities. The LD50 for oral toxicity is considered to be > 5000 mg/kg bw, LC50 is > 5.24 mg/l air. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e7a4a8d-8ca4-4c88-8f4d-c5c3723f9597/documents/IUC5-f8b20376-ebd7-4716-aff4-d3777625840c_47c09399-6ca5-44d0-866a-7a9e9247fea9.html,,,,,, Barium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate],1103-38-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e7a4a8d-8ca4-4c88-8f4d-c5c3723f9597/documents/IUC5-f8b20376-ebd7-4716-aff4-d3777625840c_47c09399-6ca5-44d0-866a-7a9e9247fea9.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Barium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate],1103-38-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e7a4a8d-8ca4-4c88-8f4d-c5c3723f9597/documents/IUC5-f8b20376-ebd7-4716-aff4-d3777625840c_47c09399-6ca5-44d0-866a-7a9e9247fea9.html,,inhalation,discriminating conc.,5.24 mg/m3,no adverse effect observed, Barium bis[5-chloro-4-ethyl-2-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate],67801-01-8,"Repeated dose toxicity of the test substance was not examined. Reliable experimental data of an analogue substance are available. Three studies are suitable to provide information on toxicity after repeated dose administration. The subacute toxicity study in rats at dose levels up to 5% (unknown purity) revealed formation of Heinzbodies, changes in hematology and pathological and histopathological changes in splenn and kidney. The 90d study at dose levels up to 10000 ppm which served as range finder for a cancer study confirms the findings of the 28d study. Additionally, congestion of the spleen and hemosiderosis in the liver was observed. A chronic study in mice at dose levels up to 1000 ppm revealed no adverse effects than changes in hematology. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/583a0fa2-682d-4236-9d1e-7e092e0d755f/documents/IUC5-c9213422-8d31-4379-91e2-77d42616c44b_a6528dbd-6db2-4fba-b950-c4d7e820a25a.html,,,,,, Barium bis[5-chloro-4-ethyl-2-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate],67801-01-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/583a0fa2-682d-4236-9d1e-7e092e0d755f/documents/IUC5-c9213422-8d31-4379-91e2-77d42616c44b_a6528dbd-6db2-4fba-b950-c4d7e820a25a.html,Chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,mouse Barium bis[5-chloro-4-ethyl-2-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate],67801-01-8,"Studies on acute toxicity of the test item were not performed. Since both substances are Ba-salts with comparable structur and similar solubility, information on acute toxicity were derived from experimental data of a structural analogue. Four studies were performed to evaluate acute oral and inhalative toxicity of the test substance to the rat (according OECD 401 and 403). The test substance did not induce mortalities, abnormalities or clinical signs when applied oral. Also single administration via the respiratory system did not cause health effects or mortalities. The LD50 for oral toxicity is considered to be > 10.000 mg/kg bw, LC50 is > 5.24 mg/l air. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/583a0fa2-682d-4236-9d1e-7e092e0d755f/documents/IUC5-6a72e332-e42c-4643-a0d4-db80e53c4465_a6528dbd-6db2-4fba-b950-c4d7e820a25a.html,,,,,, Barium bis[5-chloro-4-ethyl-2-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate],67801-01-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/583a0fa2-682d-4236-9d1e-7e092e0d755f/documents/IUC5-6a72e332-e42c-4643-a0d4-db80e53c4465_a6528dbd-6db2-4fba-b950-c4d7e820a25a.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Barium bis[5-chloro-4-ethyl-2-[(2-hydroxy-1-naphthyl)azo]benzenesulphonate],67801-01-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/583a0fa2-682d-4236-9d1e-7e092e0d755f/documents/IUC5-6a72e332-e42c-4643-a0d4-db80e53c4465_a6528dbd-6db2-4fba-b950-c4d7e820a25a.html,,inhalation,LC50,5.24 mg/m3,no adverse effect observed, Barium bis[6-chloro-4-[(2-hydroxy-1-naphthyl)azo]toluene-3-sulphonate],73612-34-7,"Repeated dose toxicity of the test substance was not examined. Reliable experimental data of an analogue substance are available. Three studies are suitable to provide information on toxicity after repeated dose administration. The subacute toxicity study in rats at dose levels up to 5% (unknown purity) revealed formation of Heinzbodies, changes in hematology and pathological and histopathological changes in splenn and kidney. The 90d study at dose levels up to 10000 ppm which served as range finder for a cancer study confirms the findings of the 28d study. Additionally, congestion of the spleen and hemosiderosis in the liver was observed. A chronic study in mice at dose levels up to 1000 ppm revealed no adverse effects than changes in hematology. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6fbbea7c-2a5e-4885-9b78-f6db2080035a/documents/IUC5-8ce5b65c-c40f-4604-a72a-68cb9b7a06a0_07ed5a16-4644-4494-bde0-9f9014afe7c7.html,,,,,, Barium bis[6-chloro-4-[(2-hydroxy-1-naphthyl)azo]toluene-3-sulphonate],73612-34-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6fbbea7c-2a5e-4885-9b78-f6db2080035a/documents/IUC5-8ce5b65c-c40f-4604-a72a-68cb9b7a06a0_07ed5a16-4644-4494-bde0-9f9014afe7c7.html,Chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,mouse Barium bis[6-chloro-4-[(2-hydroxy-1-naphthyl)azo]toluene-3-sulphonate],73612-34-7,"Studies on acute toxicity of the test item were not performed. Since both substances are Ba-salts with comparable structur and similar solubility, information on acute toxicity were derived from experimental data of a structural analogue. Four studies were performed to evaluate acute oral and inhalative toxicity of the test substance to the rat (according OECD 401 and 403). The test substance did not induce mortalities, abnormalities or clinical signs when applied oral. Also single administration via the respiratory system did not cause health effects or mortalities. The LD50 for oral toxicity is considered to be > 10.000 mg/kg bw, LC50 is > 5.24 mg/l air. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fbbea7c-2a5e-4885-9b78-f6db2080035a/documents/IUC5-c350cc06-794c-4235-9b79-ba8d04923ce6_07ed5a16-4644-4494-bde0-9f9014afe7c7.html,,,,,, Barium bis[6-chloro-4-[(2-hydroxy-1-naphthyl)azo]toluene-3-sulphonate],73612-34-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fbbea7c-2a5e-4885-9b78-f6db2080035a/documents/IUC5-c350cc06-794c-4235-9b79-ba8d04923ce6_07ed5a16-4644-4494-bde0-9f9014afe7c7.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Barium bis[6-chloro-4-[(2-hydroxy-1-naphthyl)azo]toluene-3-sulphonate],73612-34-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fbbea7c-2a5e-4885-9b78-f6db2080035a/documents/IUC5-c350cc06-794c-4235-9b79-ba8d04923ce6_07ed5a16-4644-4494-bde0-9f9014afe7c7.html,,inhalation,LC50,5.24 mg/m3,no adverse effect observed, Barium carbonate,513-77-9, Reliable studies via the oral route are available for the analogue substance barium dichloride. The main adverse effect caused by barium dichloride was the nephrotoxicity in rats and mice of both sexes. No information via the dermal and inhalation route is available for barium dichloride and other soluble barium substances. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5424760-080e-44eb-a609-bd8cfaedcfe6/documents/IUC5-14bf931f-2414-4d37-9f16-c7d8824570ec_73c55f2b-2bcb-49d1-8eae-ac06f9f728a6.html,,,,,, Barium carbonate,513-77-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5424760-080e-44eb-a609-bd8cfaedcfe6/documents/IUC5-14bf931f-2414-4d37-9f16-c7d8824570ec_73c55f2b-2bcb-49d1-8eae-ac06f9f728a6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,88 mg/kg bw/day,,rat Barium carbonate,513-77-9,Acute oral toxicity: LD50 = 1690 mg/kg bwAcute dermal toxicity: derogation statement included; according to SIAR 2008 an LD50 >1895 mg/kg was stated in the NIAR report 2008 (based on barium carbonate)Acute inhalation toxicity: data waiving ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5424760-080e-44eb-a609-bd8cfaedcfe6/documents/IUC5-bc7cd2c4-6dc0-4a99-b963-a89444412492_73c55f2b-2bcb-49d1-8eae-ac06f9f728a6.html,,,,,, Barium carbonate,513-77-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5424760-080e-44eb-a609-bd8cfaedcfe6/documents/IUC5-bc7cd2c4-6dc0-4a99-b963-a89444412492_73c55f2b-2bcb-49d1-8eae-ac06f9f728a6.html,,oral,LD50,"1,690 mg/kg bw",adverse effect observed, Barium chromate,10294-40-3,"Proprietary (guideline & GLP-compliant) acute oral, dermal and inhalation studies are available for cthe compounds in this group. A number ofadditional published studies have been reviewed by the UK Health & Safety Executive (HSE, 1989), the UK Institute of Occupational Health (IOH, 1997) and the EU RAR (2005). The EU RAR also covers the studies previously reviewed in the other two reports. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46e4c823-1a4f-42a2-a42a-74e36e2d5abb/documents/b895a684-55d5-4533-9ac6-e226785aacd3_f6500acf-d6dd-4113-a508-86db886edb4e.html,,,,,, Barium chromate,10294-40-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46e4c823-1a4f-42a2-a42a-74e36e2d5abb/documents/b895a684-55d5-4533-9ac6-e226785aacd3_f6500acf-d6dd-4113-a508-86db886edb4e.html,,oral,LD50,59 mg/kg bw,, Barium chromate,10294-40-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46e4c823-1a4f-42a2-a42a-74e36e2d5abb/documents/b895a684-55d5-4533-9ac6-e226785aacd3_f6500acf-d6dd-4113-a508-86db886edb4e.html,,dermal,LD50,"2,000 mg/kg bw",, Barium chromate,10294-40-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46e4c823-1a4f-42a2-a42a-74e36e2d5abb/documents/b895a684-55d5-4533-9ac6-e226785aacd3_f6500acf-d6dd-4113-a508-86db886edb4e.html,,inhalation,LC50,200 mg/m3,, Barium di(acetate),543-80-6," Repeated dose toxicity data are not available for barium di(acetate). However, studies conducted with soluble barium substances were included in the dossier resulting in an NOAEL for barium of 61 mg/kg bw/day that is used for the hazard assessment of barium di(acetate). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a097fd8-2f9f-43bf-a707-7826b9b74c38/documents/b8f37084-6891-4e7c-841e-193732432e4e_c0453128-c58f-48f1-8040-7c24ade580ef.html,,,,,, Barium di(acetate),543-80-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a097fd8-2f9f-43bf-a707-7826b9b74c38/documents/b8f37084-6891-4e7c-841e-193732432e4e_c0453128-c58f-48f1-8040-7c24ade580ef.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,113.5 mg/kg bw/day,,rat Barium di(acetate),543-80-6, Acute oral toxicity: 300 mg/kg bw < LD50 < 2000 mg/kg bw (LD50 cut off value: 500 mg/kg bw) (OECD 423; GLP; female rats) ; test substance: barium di(acetate) Acute inhalation toxicity: LC50 > 1 mg/L (OECD 403; GLP; female rats) (test substance: barium dichloride dihydrate recalculated to barium di(acetate) Acute dermal toxicity: derogation statement included; according to SIAR 2008 an LD50 > 2000 mg/kg was stated in the NIAR report 2008 for barium dichloride. The LD50 for barium di(acetate) is > 2000 mg/kg (re-calculated). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a097fd8-2f9f-43bf-a707-7826b9b74c38/documents/1edd2539-34b5-4fb6-a398-22202ec6164e_c0453128-c58f-48f1-8040-7c24ade580ef.html,,,,,, Barium di(acetate),543-80-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a097fd8-2f9f-43bf-a707-7826b9b74c38/documents/1edd2539-34b5-4fb6-a398-22202ec6164e_c0453128-c58f-48f1-8040-7c24ade580ef.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Barium dibenzoate,533-00-6," No repeated dose toxicity study with barium dibenzoate is available, thus the repeated dose toxicity will be addressed with existing data on the individual moieties barium and benzoate. As the two moieties of barium dibenzoate do not induce adverse effects up to and including and even 3-fold above the OECD/EC Guidelines limit dose for repeated oral dose toxicity testing, barium dibenzoate in all probability has also no potential for systemic toxicity leading to a classification. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b6d7f03-e7f3-45a7-8b2c-b4137a88c390/documents/16b9e6b3-755c-4b58-a134-fc406b482542_6fea2f25-edaf-4c99-85ea-ce397901f3a1.html,,,,,, Barium dibenzoate,533-00-6, Acute oral toxicity: LD50 value: 50 < LD50 ≤ 300 mg/ kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b6d7f03-e7f3-45a7-8b2c-b4137a88c390/documents/0138c7fa-0040-4877-9f7d-fa444bff6b10_6fea2f25-edaf-4c99-85ea-ce397901f3a1.html,,,,,, Barium dilaurate,4696-57-5," No acute toxicity studies with barium dilaurate are available, thus the acute toxicity will be addressed with existing data on the dissociation products barium and laurate. Three studies with the assessment entity barium are available and used in a weight of evidence approach resulting in a LD50>100 and <300 mg/kg bw. The assessment entity laurate does not show signs of acute oral toxicity in experimental testing (LD50 > 2000mg/kg). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ab75378-b45d-433e-9bca-25f25bde0732/documents/fb56f426-60fd-47f1-8b24-ca2fbb41d41e_375a7d34-bbdb-4a51-8eb4-b130a814cb19.html,,,,,, Barium europium strontium silicate,1003049-92-0, The test item has no acute toxic potential and thus the LD50 value is higher than 2000 mg/kg after single oral administration in rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2aa752b0-00f5-4ffa-933e-f7b420eaf930/documents/ed68a62f-5940-4763-8cd2-a722fdbaeb89_8ae9fbd0-9dea-4e55-b598-1d1ceae3c1ce.html,,,,,, Barium europium strontium silicate,1003049-92-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2aa752b0-00f5-4ffa-933e-f7b420eaf930/documents/ed68a62f-5940-4763-8cd2-a722fdbaeb89_8ae9fbd0-9dea-4e55-b598-1d1ceae3c1ce.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Barium fluoride,7787-32-8," Barium fluoride will dissociate under physiological conditions to form barium and fluoride ions. Since no data on the repeated dose toxicity are available for barium fluoride, the available studies with sodium fluoride and barium chloride were used to assess the toxicity of Ba2+ and F- ions. The calculated oral NOAEL of barium fluoride based on the NOAEL of fluoride (7.4 mg/kg bw/day) is lower than the calculated NOAEL of barium fluoride based on the NOAEL of barium (78 mg/kg bw/day) therefore it is concluded that the critical systemic toxic effects of barium fluoride after repeated exposure will be due to fluoride. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9002de0a-a736-4fdd-b16d-6499730a474b/documents/289068e5-857e-4e06-8fb2-045dc4838689_e72ecfbc-47b4-4b77-845e-0777ca0095d6.html,,,,,, Barium fluoride,7787-32-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9002de0a-a736-4fdd-b16d-6499730a474b/documents/289068e5-857e-4e06-8fb2-045dc4838689_e72ecfbc-47b4-4b77-845e-0777ca0095d6.html,Chronic toxicity – systemic effects,oral,NOAEL,7.4 mg/kg bw/day,,mouse Barium fluoride,7787-32-8, The oral LD50 exceeds 2000 mg/kg body weight. The inhalatory LC50 (4 hours) was determined at 1 -5 mg/L for male and female rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9002de0a-a736-4fdd-b16d-6499730a474b/documents/c56c23b9-e3d5-4ee4-a675-414d573a9fa0_e72ecfbc-47b4-4b77-845e-0777ca0095d6.html,,,,,, Barium hydroxide,17194-00-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efd96634-c209-4310-a45b-9ea476b39862/documents/IUC5-55a802aa-5f62-40c7-a0cf-110cf3d35522_3b3ac5ee-77a4-454b-8ce6-38f1824bac47.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,114 mg/kg bw/day,,rat Barium hydroxide,17194-00-2," The acute oral LD50 of the substance in the rat is reported to be 333 mg/kg bw (Müller, 1983); no data are available for acute dermal or inhalation toxicity however waiver are appropriate for these endpoints due to the corrosive nature of the substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efd96634-c209-4310-a45b-9ea476b39862/documents/IUC5-1ce2bad3-433f-4231-b58c-b60d55de96fd_3b3ac5ee-77a4-454b-8ce6-38f1824bac47.html,,,,,, Barium hydroxide,17194-00-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efd96634-c209-4310-a45b-9ea476b39862/documents/IUC5-1ce2bad3-433f-4231-b58c-b60d55de96fd_3b3ac5ee-77a4-454b-8ce6-38f1824bac47.html,,oral,LD50,333 mg/kg bw,adverse effect observed, Barium m-toluate,68092-47-7," No repeated dose toxicity study with barium m-toluate is available, thus the repeated dose toxicity will be addressed with existing data on the entities formed upon dissolution of barium m-toluate, namely barium and m-toluate. The hazard assessment will be conducted taking into account the toxicological information for barium and m-toluic acid reported below. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72d5a2f8-d188-45f0-b0e3-de7bb522e049/documents/c07f6cc5-5115-4330-9dd1-4d275a118c62_88783970-1275-46ee-ab54-6467785e0cfd.html,,,,,, Barium m-toluate,68092-47-7," Acute oral toxicity (OECD 423, GLP): LD50 value: 300 < LD50 ≤ 2000 mg/ kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72d5a2f8-d188-45f0-b0e3-de7bb522e049/documents/efeae819-ab99-4d61-955d-6cb1f9b736ae_88783970-1275-46ee-ab54-6467785e0cfd.html,,,,,, Barium neodecanoate,55172-98-0,Repeated exposure may cause skin dryness or cracking. No systemic toxicity is observed. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a5b031e-0225-46c6-9adb-a360414267b3/documents/IUC5-563cf22c-f768-4fbf-8dc2-c297a66d0de6_ac900db2-61f1-4e6f-868c-8173457810b4.html,,,,,, Barium neodecanoate,55172-98-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a5b031e-0225-46c6-9adb-a360414267b3/documents/IUC5-563cf22c-f768-4fbf-8dc2-c297a66d0de6_ac900db2-61f1-4e6f-868c-8173457810b4.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,, Barium neodecanoate,55172-98-0,Acute oral toxicity: LD50 ≥ 100 till ≤ 300 mg/kg bwAcute dermal toxicity: derogation statement included; according to SIAR 2008 an LD50 > 2000 mg/kg was stated in the NIAR report 2008Acute inhalation toxicity: LC50 > 1 mg/L. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a5b031e-0225-46c6-9adb-a360414267b3/documents/IUC5-74b5f17e-03fd-432a-8a62-97c7bdba63a6_ac900db2-61f1-4e6f-868c-8173457810b4.html,,,,,, Barium nitrate,10022-31-8,Repeated dose toxicity: oralDietz (1992) performed a repeated dose toxicity study with the read-across susbtance barium chloride dihydrate. The substance was administered to rats in drinking water. Male and females rats were continuously exposed up to 92 days. A NOEL of 61.1 mg Ba/kg bw/day was derived (116.3 mg Ba nitrate/kg bw/day). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/349110a3-8d5f-4457-9e3f-5cd743a1f9b0/documents/IUC5-05bfbbd9-9f5e-47e5-b48d-cd9a7dedf521_e8847444-1c92-49ef-8f51-6f1dfb80d505.html,,,,,, Barium nitrate,10022-31-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/349110a3-8d5f-4457-9e3f-5cd743a1f9b0/documents/IUC5-05bfbbd9-9f5e-47e5-b48d-cd9a7dedf521_e8847444-1c92-49ef-8f51-6f1dfb80d505.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,116.3 mg/kg bw/day,,rat Barium nitrate,10022-31-8,"Acute toxicity: oralOne K1 study is available (van Huygevoort, 2013). Under the test conditions a LD50 of 300 mg/kg bw in female Wistar rats was derived. This study was performed according to OECD guideline 423, EU method B.1 tris and EPA OPPTS 870.1100.Acute toxicity: inhalationA K2 acute inhalation toxicity test was performed in male and female Wistar rats according to the OECD 403 Guideline (van Huygevoort, 2010) with the read-across substance barium dichloride dihydrate. The acute inhalation LC50 value was derived to be > 1.1 mg/L air (analytical).Acute toxicity: dermalStudy not required. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/349110a3-8d5f-4457-9e3f-5cd743a1f9b0/documents/IUC5-a0d8eef3-84ab-4761-ba3d-29e0922714e1_e8847444-1c92-49ef-8f51-6f1dfb80d505.html,,,,,, Barium nitrate,10022-31-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/349110a3-8d5f-4457-9e3f-5cd743a1f9b0/documents/IUC5-a0d8eef3-84ab-4761-ba3d-29e0922714e1_e8847444-1c92-49ef-8f51-6f1dfb80d505.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Barium nitrate,10022-31-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/349110a3-8d5f-4457-9e3f-5cd743a1f9b0/documents/IUC5-a0d8eef3-84ab-4761-ba3d-29e0922714e1_e8847444-1c92-49ef-8f51-6f1dfb80d505.html,,inhalation,LC50,"1,100 mg/m3",adverse effect observed, "Barium oxide (BaO), solid soln. with calcium oxide, magnesium oxide, phosphorus oxide (P2O5), strontium oxide and zinc oxide, copper-doped",101356-96-1," REACH Annex VII column 2 states that testing by the inhalation route is appropriate if exposure of humans via inhalation is likely. Forming insoluble particulate matter, the inhalation route was considered the most appropriate exposure pathway for strontium apatite, copper doped. A reliable (Klimisch 1), GLP compliant, OECD Guideline 436 study was conducted for the test item (Haferkorn 2017). CD/Crl(SD) rats (3 male; 3 female) were exposed to an aerosol dust of strontium apatite, copper doped at a gravimetrically determined concentration of 5.06±0.02 mg/L air for 4 hours by inhalation, via nose-only exposure. The dust particles had a Mass Median Aerodynamic Diameter (MMAD) or 1.752 µm and a Geometric Standard Deviation (GSD) or 2.32. Under the test conditions in the study, 4-hour inhalation exposure induced slight dyspnoea until 3 hours post exposure in all rats. No other clinical signs of toxicity, mortality or pathological changes at necropsy, were observed in the treated rats. Therefore, under the conditions of the test, the LC50 value for rats following inhalation of strontium apatite, copper doped for 4 hours was determined as >5.06 mg/L air. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/497fe001-a91f-4c35-83db-d0fa1345592b/documents/a79b4593-dc01-4b2d-8cb8-9f9155418397_1626e6e5-4756-4470-92a4-1725883ac01f.html,,,,,, "Barium oxide (BaO), solid soln. with calcium oxide, magnesium oxide, phosphorus oxide (P2O5), strontium oxide and zinc oxide, copper-doped",101356-96-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/497fe001-a91f-4c35-83db-d0fa1345592b/documents/a79b4593-dc01-4b2d-8cb8-9f9155418397_1626e6e5-4756-4470-92a4-1725883ac01f.html,,inhalation,LC50,5.06 mg/m3,no adverse effect observed, "Barium oxide, obtained by calcining witherite",1304-28-5,"Repeated Dose 90-day Oral Toxicity Study (NTP, 1990): NOAEL (rat) = 65 mg/kg bw/day, NOAEL (mouse) = 100 mg/kg bw/day, test substance BaCl2*2H2O ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ead87090-aca2-47d9-ae0e-ab151b5ecaec/documents/IUC5-70661118-a888-4564-bd1c-c8967fd3c3e0_ff765e0d-ae5e-42da-8c22-4c5fd2e9fe5b.html,,,,,, "Barium oxide, obtained by calcining witherite",1304-28-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ead87090-aca2-47d9-ae0e-ab151b5ecaec/documents/IUC5-70661118-a888-4564-bd1c-c8967fd3c3e0_ff765e0d-ae5e-42da-8c22-4c5fd2e9fe5b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,65 mg/kg bw/day,,rat "Barium oxide, obtained by calcining witherite",1304-28-5,acute oral toxicity study similar to OECD 401 (Tardiff et al. 1980): LD50 = 132 mg /kg bw (test substance BaCl2) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ead87090-aca2-47d9-ae0e-ab151b5ecaec/documents/IUC5-47f940b0-32ab-4a36-bb99-3a8e9e012678_ff765e0d-ae5e-42da-8c22-4c5fd2e9fe5b.html,,,,,, Barium phosphinate,14871-79-5," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The study concluded that the LD50 value is >5000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c27c9679-cfde-4a4c-bd52-bc8b00057777/documents/81eaa26a-84c5-4ecb-a5b1-023a6d398b30_380ea82b-4678-43ab-92c8-55af4503d232.html,,,,,, Barium phosphinate,14871-79-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c27c9679-cfde-4a4c-bd52-bc8b00057777/documents/81eaa26a-84c5-4ecb-a5b1-023a6d398b30_380ea82b-4678-43ab-92c8-55af4503d232.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Barium selenite,13718-59-7,"Background A read-across category-approach is used for the assessment of the toxicological properties of selenium and selenium compounds. The following Se-substance are included in the category: Se-metal (massive, powder) Disodium selenate Disodium selenite Selenium dioxide / selenious acid Zinc selenite Barium selenite A detailed rationale for the read-across hypothesis has been outlined in the read-across report that was generated according to the principles laid out in the Read-Across Assessment Framework (RAAF). In summary, the physico-chemical behavior of elemental selenium (once it has formed an ion-from its metal state), disodium selenite, disodium selenate and selenium dioxide/selenious acid is the same with regard to their metabolic fate. All selenium compounds (organic and inorganic, including elemental selenium), do share the very same metabolic fate in that after their resorption, reduction to the selenide moiety [Se2-], which is the single common precursor for its further metabolic conversion, takes place. Therefore, there seems to be good evidence that different selenium moieties will behave very similar also for their ability to form reactive species which may play a decisive role in the generation of cytotoxicity followed likewise by unspecific and secondary clastogenicity and read-across can be made from the available data for disodium selenite. It is concluded that additional testing for each individual member of the proposed Se-category is not necessary and scientifically not meaningful. In the case of inorganic salts like barium selenite and zinc selenite, uptake is always associated with a dissolution of the substance, i.e. dissociation into the metal cation (Zn2+, Ba2+) and the selenite anion (SeO32-). It can safely be assumed that the selenium/selenite moiety of barium/zinc selenite is generally of higher toxicological relevance than the zinc/barium cations. Therefore, the subsequent assessment of the toxicity of barium/zinc selenite focuses on the selenium moiety. As no in vivo toxicokinetic data or in vitro bioaccessibility data are available for a comparative assessment of relative bioavailability of various selenite substances, water solubility is adopted as a surrogate for bioavailability. Disodium selenite is readily soluble, with a water solubility of 800-900 g/L at 20°C. Barium selenite and zinc selenite, on the other hand, are poorly soluble salts (water solubility at 20°C of 66.7 mg/L and 16 mg/L, respectively, i.e. a difference of four/five orders of magnitude). Based on that, an intrinsically very conservative read-across from highly soluble forms to the poorly soluble barium/zinc selenite is proposed as the latter are assumed to have a lower solubility. It should also be noted that selenite anions in the tests with disodium selenite are formed under most physiological relevant conditions (i.e. neutral pH), thus facilitating unrestricted read-across between the various substances. In slightly acid conditions (pKa:8.32) the hydrogen selenite ion (HSeO3-) is formed whereas in more acidic conditions (pKa:2.62) the formation of selenious acid is observed (H2SeO3). Based on such existing equilibrium conditions, read-across between selenites, hydrogen selenites and selenious acid (solubility of 1670 g/L at 20°C) is justified.   Read-across from sodium selenite and selenious acid to barium/zinc selenite Based on a comparison between toxicity reference values of zinc compounds and selenium compounds, it can safely be assumed that the selenium/selenite moiety of zinc selenite is generally of higher toxicological relevance than the zinc cations. Comparing the DNELs for the zinc/barium ion itself with the zinc/barium levels that are associated with the DNELs for barium/zinc selenite (based on selenite-data) indicated significantly higher values (in the range of factor 10 to 20) for the DNELs derived for the barium/zinc ion itself. Therefore, the subsequent assessment of the toxicity of barium/zinc selenite focuses on the selenium moiety.   Several reliable short-term repeated dose and sub-chronic studies are available for the oral route: Abdo (1994), NOAEL rat: 0.4 mg Se/kg bw/d (sub-chronic test with sodium selenite), NOAEL 0.4 mg Se/kg bw/d (sub-chronic test with sodium selenate) Abdo (1994), NOAEL mouse: 0.9 mg Se/kg bw/d (sub-chronic test with sodium selenite), NOAEL 0.8 mg Se/kg bw/d (sub-chronic test with sodium selenate) Bioulac (1992), NOAEL rat: 0.12 mg Se/kg bw/d (test with sodium selenite) Johnson (2000), NOAEL mouse: 0.36 mg Se/kg bw/d (test with sodium selenite) Based on these data, a NOAEL for rats of 0.4 mg Se/ kg bw/day has been selected as the key value for repeated dose toxicity via the oral route for the different Se-compounds within the current category. No studies on repeated dose toxicity via inhalation or dermal route are available.   Yang et al. (1989): NOAEL man: Se-intake of 850 µg Se/day per person; this figure is used as starting point for DNEL derivation. It has to be emphasized, that the NOAEL according to Yang et al. (1989), which is used as starting point for DNEL derivation is based on human data. The existing studies on humans are considering a wealth of toxicological endpoints and overrule the available animal-based data by far. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d63e0b0-7a5b-4b1f-b2bb-d3bc5964f767/documents/0ed5fd34-73be-44ea-9b49-0d09e04fc020_8038bcfe-71c9-4524-80fa-d12e1cd157ea.html,,,,,, Barium selenite,13718-59-7," •  Acute oral toxicity: 68.9 – 687 mg/kg bw; MW conversion from zinc selenite to barium selenite LD50 of 50 – 500 mg/kg bw (Prinsen, 1996c)   •  Acute inhalation toxicity: LC50 1.37 – 6.87 mg/L; MW conversion from zinc selenite to barium selenite of 1- 5 mg/L (Leuschner, 2010)   •  Dermal toxicity: waived  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Read-across from literature data of good quality Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Read-across from GLP study of hight quality (Klimisch 1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d63e0b0-7a5b-4b1f-b2bb-d3bc5964f767/documents/a106b512-ae23-457e-98a6-61d7d949a363_8038bcfe-71c9-4524-80fa-d12e1cd157ea.html,,,,,, Barium selenite,13718-59-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d63e0b0-7a5b-4b1f-b2bb-d3bc5964f767/documents/a106b512-ae23-457e-98a6-61d7d949a363_8038bcfe-71c9-4524-80fa-d12e1cd157ea.html,,oral,LD50,68.9 mg/kg bw,adverse effect observed, Barium selenite,13718-59-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d63e0b0-7a5b-4b1f-b2bb-d3bc5964f767/documents/a106b512-ae23-457e-98a6-61d7d949a363_8038bcfe-71c9-4524-80fa-d12e1cd157ea.html,,inhalation,LC50,>=1.37 mg/L,adverse effect observed, Barium titanium trioxide,12047-27-7,"Repeated dose toxicity oral:• read-across, key study, subchronic (90 d), oral, Fischer 344 rats; NOAEL ≥ 103 mg/kg bw/d (no guideline followed, Dietz et al., 1992) • read-across, supporting study, subchronic (90 d), oral, Fischer 344 rats; NOAEL ≥ 186 mg/kg bw/d (no guideline followed, Anonymous, NTP 1994) For the TiO2 element of the substance, No systemic toxicological effects were related with the agglomerated/aggregated TiO2 P25 in the repeated-dose 28-day and 90-day oral toxicity and 28-day recovery studies in SD rats under the experimental conditions used. Therefore, the NOAEL of the agglomerated/aggregated TiO2 P25 was identified as 1000 mg kg− 1 d− 1, and this test substance was not detected in the target organs. The toxicity of barium titanium trioxide and barium chloride is based on the cation Ba2 + and on the water solubility (dependent on the Ba2+ concentration). Barium chloride is a well water soluble substance whereas barium carbonate is low soluble in water. The NOAEL of Barium chloride dihydrate is 2000 ppm which corresponds to a NOAEL of 80.9 mg Ba2+/kg bw/day for females and a NOAEL of 61.1 mg Ba2+/kg bw/day for males. As a worst case assumption it can be concluded that the NOAEL for barium titanium trioxide is ≥ 103 mg/kg bw/day based on the nominal test item application. Repeated dose toxicity inhalation: no dataRepeated dose toxicity dermal: no data ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7671d24-7961-404a-a3bf-aedbf23c5148/documents/IUC5-ec619c13-5c19-4750-9b40-58516cfd2e8d_1aa61b7c-1372-4d05-b98c-80f1d1ea703d.html,,,,,, Barium titanium trioxide,12047-27-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7671d24-7961-404a-a3bf-aedbf23c5148/documents/IUC5-ec619c13-5c19-4750-9b40-58516cfd2e8d_1aa61b7c-1372-4d05-b98c-80f1d1ea703d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,103.75 mg/kg bw/day,,rat Barium titanium trioxide,12047-27-7,"Acute oral toxicityin vivo, rat: LD50 > 12000 mg/kg bw (non GLP, no guideline, Brown & Mastromatteo, 1962)Acute inhalation toxicityin vivo, rat: LC50 > 4.89 mg/L air (GLP, OECD 403, TÜV SÜD PSB, 2012)Acute dermal toxicityin vivo, rat: LD50 > 2000 mg/kg bw (GLP, OECD 402, TÜV SÜD PSB, 2012) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7671d24-7961-404a-a3bf-aedbf23c5148/documents/IUC5-d9be0c70-268e-492a-90d4-2a284346ba8c_1aa61b7c-1372-4d05-b98c-80f1d1ea703d.html,,,,,, Barium titanium trioxide,12047-27-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7671d24-7961-404a-a3bf-aedbf23c5148/documents/IUC5-d9be0c70-268e-492a-90d4-2a284346ba8c_1aa61b7c-1372-4d05-b98c-80f1d1ea703d.html,,oral,discriminating dose,"12,000 mg/kg bw",no adverse effect observed, Barium titanium trioxide,12047-27-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7671d24-7961-404a-a3bf-aedbf23c5148/documents/IUC5-d9be0c70-268e-492a-90d4-2a284346ba8c_1aa61b7c-1372-4d05-b98c-80f1d1ea703d.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Barium titanium trioxide,12047-27-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7671d24-7961-404a-a3bf-aedbf23c5148/documents/IUC5-d9be0c70-268e-492a-90d4-2a284346ba8c_1aa61b7c-1372-4d05-b98c-80f1d1ea703d.html,,inhalation,discriminating conc.,"4,890 mg/m3",no adverse effect observed, Barium zirconium trioxide,12009-21-1," Studies on the acute oral toxicity of barium zirconate revealed that they are of relatively low toxicity, which may be due in part to the insolubility of this material. However, rats given barium zirconate at levels in the 3.0 and 6.0 g/kg range finding tests all died and so testing at lower levels up to 5 g/kg were carried out. In those instances where a lethal dose was administered the majority of the animals died within 12 hours,although some survived for as long as 36 hours. The gross pathological and histological examinations carried out on these animals showed no characteristic changes. The analysis for the barium zirconate that was used for these tests appears to have had some barium carbonate impurity. Barium carbonate is soluble and exhibits acute oral toxicity in the rage 1600 - 2000 mg/kg/bw. It may be that the fact that this impurity was present was the cause of the acute oral toxicity in the barium zirconate tested.   Nevertheless, the barium zirconate substance under registration also contains low level barium carbonate impurity albeit not at the same high level as the test material in this study report. However, a precautionary approach has been taken in the absence of any further available oral toxicity data and this substance has been classified as poentially harmful by ingestion. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d8966c9-91ea-4a17-a931-20f062045d2e/documents/d5d50d3a-106d-41a8-9870-7fd7ed7ff102_e4a12b39-ef86-49b8-89b1-793359af94d1.html,,,,,, Barium zirconium trioxide,12009-21-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d8966c9-91ea-4a17-a931-20f062045d2e/documents/d5d50d3a-106d-41a8-9870-7fd7ed7ff102_e4a12b39-ef86-49b8-89b1-793359af94d1.html,,oral,LD50,"1,980 mg/kg bw",adverse effect observed, Barium(2+) 12-hydroxyoctadecanoate,21598-22-1," In an acute oral toxicity assay according to OECD guideline 423 (acute toxic class method, ATC), a LD50 of above 2000 mg/kg bw was determined. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d817296c-89cb-428d-ba0d-8bc126e60060/documents/598f0216-f614-45e9-b056-4a574b56edd0_ca66961a-2053-4988-b6e8-ffd24c2e8583.html,,,,,, Barium(2+) 12-hydroxyoctadecanoate,21598-22-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d817296c-89cb-428d-ba0d-8bc126e60060/documents/598f0216-f614-45e9-b056-4a574b56edd0_ca66961a-2053-4988-b6e8-ffd24c2e8583.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Bentonite, acid-leached",70131-50-9,"Acute toxicity of bentonite acid leached has been tested via the oral, inhalation and dermal route. Acute oral toxicity study in rats LD50 > 5000 mg/kg, Acute inhalation toxicity study in rats LC50 > 50 mg/L and acute dermal toxicity in rats (OECD TG ) LD50 > 2000 mg/kg. Bentonite acid leached is not considered to be harmful by either route and is not classified for acute toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ffd6529-f3f7-4b66-ba75-7c0185090755/documents/IUC5-f4f3ad39-bad4-4cbd-a389-6e351f4d54ae_1f7c714f-bb4a-4b2d-ba19-11e547e17535.html,,,,,, Benz[cd]indol-2(1H)-one,130-00-7,"Data on toxicity of the substance is available from preliminary limit tests. The reported values are all far above 2000 mg/kg. Therefore the substance is not considered to be toxic if swallowed. Even though there is no study on dermal toxicity available, during test of sensitizing and irritating properties no mortallity or sign of intoxication were observed. In a screening test for inhalative toxicity no animal died over a period of 8 h. Since the substance is solely used as an intermediate in industrial processes and the toxicity of the substance obviously is low, no justification for further testing can be seen. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/002b195e-24b7-463b-98d4-a522b4f19f03/documents/IUC5-2df7fc31-404f-4a9f-b332-41228345d727_ffb36a0d-8f33-462d-990b-8c6d58775993.html,,,,,, 2-Hydroxy-5-nonyl(branched)-benzaldehyde oxime,174333-80-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba712052-d76f-4252-a323-fc4243d8d6d1/documents/c9dfd9fa-4591-4669-97b5-3829e98677a3_6e8eef9f-4c09-4d10-ab7c-eeb56971b262.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat 2-Hydroxy-5-nonyl(branched)-benzaldehyde oxime,174333-80-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba712052-d76f-4252-a323-fc4243d8d6d1/documents/5683454b-bff3-4a53-9d0d-7de0e6e11c5b_6e8eef9f-4c09-4d10-ab7c-eeb56971b262.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, 2-Hydroxy-5-nonyl(branched)-benzaldehyde oxime,174333-80-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba712052-d76f-4252-a323-fc4243d8d6d1/documents/5683454b-bff3-4a53-9d0d-7de0e6e11c5b_6e8eef9f-4c09-4d10-ab7c-eeb56971b262.html,,dermal,discriminating dose,"2,000 mg/kg bw",adverse effect observed, 2-Ethoxy-4-formylphenyl β-D-glucopyranoside,122397-96-0, Oral LD50 in rats > 50000 mg/kg b.w. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d54af7ca-f6f4-48c5-abdd-3cb19cd71bd7/documents/da240e88-9392-4068-a1b8-860bbc62145a_f1a968c6-cef8-4ab0-9a27-9f573ffacef8.html,,,,,, 3-Amino-4-methoxy-N-methylbenzamide,878160-14-6," The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was approximately 500 mg/kg body weight (LD50 cut-off: 500 mg/kg body weight, Globally Harmonized Classification System: Category 4, >300 - 2000 mg/kg body weight). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1970b744-b0a7-4f37-a7be-a2232806bf04/documents/e9ad239f-55f0-40e4-bf59-4d1238e1e05c_aa0e354d-b817-4d3c-9836-7461de12466f.html,,,,,, 3-Amino-4-methoxy-N-methylbenzamide,878160-14-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1970b744-b0a7-4f37-a7be-a2232806bf04/documents/e9ad239f-55f0-40e4-bf59-4d1238e1e05c_aa0e354d-b817-4d3c-9836-7461de12466f.html,,oral,LD50,500 mg/kg bw,adverse effect observed, 2-({2-[(3-aminobenzoyl)amino]ethyl}sulfonyl)ethyl hydrogen sulfate,121315-20-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/037e4089-a4e9-4d18-b443-f319113b52dd/documents/IUC5-b8c3a74d-af1b-4271-9cf6-7da7b2406710_fc9fac1e-0146-4bf7-829f-d3fc65b205f4.html,,oral,LD50,"2,000 mg/kg bw",, 4-Methoxy-N-methyl-3-nitrobenzamide,333350-60-0," The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was approximately 500 mg/kg body weight (LD50 cut-off: 500 mg/kg body weight, Globally Harmonized Classification System: Category 4, >300 - 2000 mg/kg body weight). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc0dcd74-ef59-427d-b49c-f5dd659e1a5f/documents/99c2c800-30c3-46ee-9d30-f1ebc0d6c436_0b707dc5-d87d-4b8d-97e3-0e985e288feb.html,,,,,, 4-Methoxy-N-methyl-3-nitrobenzamide,333350-60-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc0dcd74-ef59-427d-b49c-f5dd659e1a5f/documents/99c2c800-30c3-46ee-9d30-f1ebc0d6c436_0b707dc5-d87d-4b8d-97e3-0e985e288feb.html,,oral,LD50,500 mg/kg bw,adverse effect observed, N-(5-bromo-3-methylpyridin-2-yl)-N-methylbenzamide,446299-80-5,"Acute oral toxicity: Key study. Test method according to OECD 420, GLP study. The LD50 of the test item is higher than 2000 mg/ kg body weight by oral route in the rat. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Key study with Klimisch score = 1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74ac4be9-e38e-42c4-895c-4b111256858a/documents/2cccf1a3-23aa-4d58-b59b-fa60ab95105d_31858cbb-ab90-4a34-8668-643b347d1558.html,,,,,, N-(5-bromo-3-methylpyridin-2-yl)-N-methylbenzamide,446299-80-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74ac4be9-e38e-42c4-895c-4b111256858a/documents/2cccf1a3-23aa-4d58-b59b-fa60ab95105d_31858cbb-ab90-4a34-8668-643b347d1558.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-(4-chlorophenyl)-6-(N,N-dibutylbenzamide)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione",1391764-61-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Key study quoted as reliability 1 according to Klimisch criteria (performed according to OECD guidelines and in accordance with GLP) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcb8de93-5ddf-45fd-bffc-92031d24ce47/documents/IUC5-f2d36300-f2b8-4d92-8f48-67ee681da3c4_7114cd90-89ce-4f63-b262-198be40381e7.html,,,,,, "3-(4-chlorophenyl)-6-(N,N-dibutylbenzamide)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione",1391764-61-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcb8de93-5ddf-45fd-bffc-92031d24ce47/documents/IUC5-f2d36300-f2b8-4d92-8f48-67ee681da3c4_7114cd90-89ce-4f63-b262-198be40381e7.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "1,2-Bis(2-aminophenoxy)ethane",52411-34-4,"Oral administration of the test material, 1,2-Bis(2-aminophenoxy)ethane, to rats for a period of twenty-eight consecutive days at dose levels of up to 1000 mg/kg/day resulted in adverse toxicological changes at 1000 mg/kg/day only. Minimal adaptive hepatic changes were identified histopathologically for animals treated with 1000 and 250 mg/kg/day and also for one male dosed at 50 mg/kg/day but these effects were considered to represent a normally expected adaptive response to treatment and were considered not to be indicative of an adverse toxicological effect. The ""No Observed Adverse Effect Level"" (NOAEL) is, therefore, considered to be 250 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fad5dc5a-e6cc-4748-85d9-912286d65420/documents/f4928df8-18a8-41d4-81fe-7e5e258e46cd_9f0cf778-d951-4a2e-be0e-0861835b2af7.html,,,,,, "1,2-Bis(2-aminophenoxy)ethane",52411-34-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fad5dc5a-e6cc-4748-85d9-912286d65420/documents/f4928df8-18a8-41d4-81fe-7e5e258e46cd_9f0cf778-d951-4a2e-be0e-0861835b2af7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,>= 250 mg/kg bw/day,,rat "1,2-Bis(2-aminophenoxy)ethane",52411-34-4,Acute oral toxicity  Bis-(Aminophenoxy)-ethane did not cause any mortality or clinical signs or necropsy findings after single oral gavage administration to female rats at 2000 mg/kg bw in a OECD guideline and GLP compliant study. The LD50 (female rat) was greater than 2000 mg/kg body weight. Acute dermal toxicity  Bis-(Aminophenoxy)-ethane did not cause any mortality or clinical signs or necropsy findings after single dermal gavage administration to male and female rats at 2000 mg/kg bw in a OECD guideline and GLP compliant study. The LD50 (male/female rat) was greater than 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fad5dc5a-e6cc-4748-85d9-912286d65420/documents/746522d8-3e16-446f-9662-6ec03cf5e540_9f0cf778-d951-4a2e-be0e-0861835b2af7.html,,,,,, "1,2-Bis(2-aminophenoxy)ethane",52411-34-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fad5dc5a-e6cc-4748-85d9-912286d65420/documents/746522d8-3e16-446f-9662-6ec03cf5e540_9f0cf778-d951-4a2e-be0e-0861835b2af7.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1,2-Bis(2-aminophenoxy)ethane",52411-34-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fad5dc5a-e6cc-4748-85d9-912286d65420/documents/746522d8-3e16-446f-9662-6ec03cf5e540_9f0cf778-d951-4a2e-be0e-0861835b2af7.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline",105112-76-3,"A study was performed to test the effects of repeated doses of the test substance 3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline to CD rats for 28 days ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e586f015-bdb9-4f1a-8d3d-9d7daca1dcba/documents/IUC5-9eabc5be-9bf7-495e-bac4-a13004f0b071_90064439-0bc0-4727-981a-d696a574fc46.html,,,,,, "3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline",105112-76-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e586f015-bdb9-4f1a-8d3d-9d7daca1dcba/documents/IUC5-9eabc5be-9bf7-495e-bac4-a13004f0b071_90064439-0bc0-4727-981a-d696a574fc46.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,, "3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline",105112-76-3,"The acute toxicity of 3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline has been studied in the rat for the oral and dermal routes. No information about the acute inhalation toxicity of 3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline is available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e586f015-bdb9-4f1a-8d3d-9d7daca1dcba/documents/IUC5-d0090700-3b58-445d-a931-12e4ade408ac_90064439-0bc0-4727-981a-d696a574fc46.html,,,,,, "3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline",105112-76-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e586f015-bdb9-4f1a-8d3d-9d7daca1dcba/documents/IUC5-d0090700-3b58-445d-a931-12e4ade408ac_90064439-0bc0-4727-981a-d696a574fc46.html,,oral,LD50,"2,000 mg/kg bw",, "3,3'-[biphenyl-4,4'-diylbis(oxy)]dianiline",105112-76-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e586f015-bdb9-4f1a-8d3d-9d7daca1dcba/documents/IUC5-d0090700-3b58-445d-a931-12e4ade408ac_90064439-0bc0-4727-981a-d696a574fc46.html,,dermal,LD50,"2,000 mg/kg bw",, "Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatephosphates",67989-22-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline study Klimisch 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/148b0a5b-6d80-43e6-b2b6-7d9c7e47f60a/documents/5c5582c3-11c8-41dd-9d40-ee13cc5efe22_86293fe4-e39c-4edf-a872-1af91d7c2fa1.html,,,,,, "Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatephosphates",67989-22-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/148b0a5b-6d80-43e6-b2b6-7d9c7e47f60a/documents/5c5582c3-11c8-41dd-9d40-ee13cc5efe22_86293fe4-e39c-4edf-a872-1af91d7c2fa1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatephosphates",67989-22-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Guideline study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/148b0a5b-6d80-43e6-b2b6-7d9c7e47f60a/documents/d8ac62d8-aab2-4aa0-8e8e-71aaa81c9ee5_86293fe4-e39c-4edf-a872-1af91d7c2fa1.html,,,,,, "Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatephosphates",67989-22-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/148b0a5b-6d80-43e6-b2b6-7d9c7e47f60a/documents/d8ac62d8-aab2-4aa0-8e8e-71aaa81c9ee5_86293fe4-e39c-4edf-a872-1af91d7c2fa1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatesilicates",68647-35-8," Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatesilicates (68647-35-8 ) . The study assumed the use of male and female Osborne-Mendel in chronic study of 17 weeks. No significant alterations were noted at the dose level of 721.86 mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for compound Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatesilicates is considered to be 721.86 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5cdaec8d-0a9c-4507-a704-f8061ba3208e/documents/cb656160-3c0e-4c16-9d17-c7216f8b841a_320502b5-9b45-4a9d-94b1-1c54122ed73c.html,,,,,, "Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatesilicates",68647-35-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5cdaec8d-0a9c-4507-a704-f8061ba3208e/documents/cb656160-3c0e-4c16-9d17-c7216f8b841a_320502b5-9b45-4a9d-94b1-1c54122ed73c.html,Chronic toxicity – systemic effects,oral,NOAEL,721.86 mg/kg bw/day,,rat "Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatesilicates",68647-35-8," Acute oral toxicity:  Acute oral toxicity dose (LD50) of Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatesilicates (CAS no: 68647-35-8) was predicted based on OECD QSAR toolbox 6007 mg/kg bw and different studies available on structurally similar read across substance Hydrogen [4-[4-(dimethylamino)-α-(2-hydroxy-3,6-disulphonato-1-naphthyl)benzylidene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium, monosodium salt (CAS no.: 3087-16-9) >2000 mg/kg bw. Both these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatesilicates cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  The acute inhalation toxicity study need not be conducted because exposure of humans via inhalation route is not likely taking into account due to the low vapour pressure of the substance Benzenamine, 4-[(4-aminophenyl)(4 -imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatesilicates (CAS No. 68647-35-8 ), which is reported as 2.70E-9 Pa; High melting point, which is reported as 355.3-358°C; Also considering the particle size distribution of the substance, the majority of the particles were found to be in the size of range 150 micrometer to 25 micrometer which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical Benzenamine, 4-[(4-aminophenyl)(4 -imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatesilicates is highly unlikely. Therefore this study is considered for waiver. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for Benzenamine, 4-[(4-aminophenyl)(4 -imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatesilicates (CAS No. 68647-35-8 ) was predicted based on OECD QSAR toolbox 9252 mg/kg bw and study available for the structurally similar read across substances [4-[[4-anilino-1-naphthyl][4-(dimethylamino) phenyl]methylene] cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate (CAS No. 83803-79-6) >2000 mg/kg bw and [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl] methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate (CAS No. 84434-47-9) >2000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Benzenamine, 4-[(4-aminophenyl)(4 -imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatesilicates cannot be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cdaec8d-0a9c-4507-a704-f8061ba3208e/documents/21cc52d2-13c3-4b80-b533-316000c9f78f_320502b5-9b45-4a9d-94b1-1c54122ed73c.html,,,,,, "Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatesilicates",68647-35-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cdaec8d-0a9c-4507-a704-f8061ba3208e/documents/21cc52d2-13c3-4b80-b533-316000c9f78f_320502b5-9b45-4a9d-94b1-1c54122ed73c.html,,oral,LD50,"6,007 mg/kg bw",no adverse effect observed, "Benzenamine, 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]-, N-Me derivatives, molybdatesilicates",68647-35-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cdaec8d-0a9c-4507-a704-f8061ba3208e/documents/21cc52d2-13c3-4b80-b533-316000c9f78f_320502b5-9b45-4a9d-94b1-1c54122ed73c.html,,dermal,LD50,"9,252 mg/kg bw",no adverse effect observed, "Benzenamine, N,N-dimethyl-, oxidized, molybdatetungstatephosphates",101357-19-1," OECD422, oral, rat (m/f), NOAEL = 1000 mg/kg bw /day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/95315211-2a1a-4273-9ba0-7d16a68cb5bb/documents/282e6f9d-08a6-40b1-8caf-b02a2bf21fdc_e2713372-4bf8-48f6-b673-5cee8e4e923e.html,,,,,, "Benzenamine, N,N-dimethyl-, oxidized, molybdatetungstatephosphates",101357-19-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/95315211-2a1a-4273-9ba0-7d16a68cb5bb/documents/282e6f9d-08a6-40b1-8caf-b02a2bf21fdc_e2713372-4bf8-48f6-b673-5cee8e4e923e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Benzenamine, N,N-dimethyl-, oxidized, molybdatetungstatephosphates",101357-19-1," LD50, rat, oral, (m/f) > 2000 mg/kg OECD 401, limit test LC0, inhalation, > 6.51 mg/l, OECD 403 LD50, dermal > 2500 mg/kg, OECD 402 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95315211-2a1a-4273-9ba0-7d16a68cb5bb/documents/ecc2c4a5-1f49-4f71-a0a4-c18795e6dd2f_e2713372-4bf8-48f6-b673-5cee8e4e923e.html,,,,,, "Benzenamine, N,N-dimethyl-, oxidized, molybdatetungstatephosphates",101357-19-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95315211-2a1a-4273-9ba0-7d16a68cb5bb/documents/ecc2c4a5-1f49-4f71-a0a4-c18795e6dd2f_e2713372-4bf8-48f6-b673-5cee8e4e923e.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Benzenamine, N,N-dimethyl-, oxidized, molybdatetungstatephosphates",101357-19-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95315211-2a1a-4273-9ba0-7d16a68cb5bb/documents/ecc2c4a5-1f49-4f71-a0a4-c18795e6dd2f_e2713372-4bf8-48f6-b673-5cee8e4e923e.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, "Benzenamine, N,N-dimethyl-, oxidized, molybdatetungstatephosphates",101357-19-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95315211-2a1a-4273-9ba0-7d16a68cb5bb/documents/ecc2c4a5-1f49-4f71-a0a4-c18795e6dd2f_e2713372-4bf8-48f6-b673-5cee8e4e923e.html,,inhalation,LC50,6.51 mg/m3,no adverse effect observed, "Benzenamine, N-phenyl-, reaction products with 2,4,4-trimethylpentene",68411-46-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/393b65f5-7978-4289-8aab-810035679241/documents/IUC5-decafa79-1162-4e26-a6a8-5537e421127f_c4137d35-e937-4206-a60e-8a4b617a9232.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,< 18 mg/kg bw/day,,rat "Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene",68921-45-9,Repeat dose exposure is discussed ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/915ad6f3-a04c-4867-a95d-7be5be6fded8/documents/IUC5-5337f27d-d91e-4275-9e5f-080948ffc6bd_d4747a08-6daa-4880-bf67-54ec18594e56.html,,,,,, "Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene",68921-45-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/915ad6f3-a04c-4867-a95d-7be5be6fded8/documents/IUC5-5337f27d-d91e-4275-9e5f-080948ffc6bd_d4747a08-6daa-4880-bf67-54ec18594e56.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat "Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene",68921-45-9,Acute toxicity is discussed. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/915ad6f3-a04c-4867-a95d-7be5be6fded8/documents/IUC5-7bc5f284-eef5-4329-8da3-6fa842d3c7ef_d4747a08-6daa-4880-bf67-54ec18594e56.html,,,,,, "Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene",68921-45-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/915ad6f3-a04c-4867-a95d-7be5be6fded8/documents/IUC5-7bc5f284-eef5-4329-8da3-6fa842d3c7ef_d4747a08-6daa-4880-bf67-54ec18594e56.html,,oral,LD50,"20,000 mg/kg bw",no adverse effect observed, "Benzenamine, N-phenyl-, reaction products with styrene and 2,4,4-trimethylpentene",68921-45-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/915ad6f3-a04c-4867-a95d-7be5be6fded8/documents/IUC5-7bc5f284-eef5-4329-8da3-6fa842d3c7ef_d4747a08-6daa-4880-bf67-54ec18594e56.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, "Benzenamine, N-phenyl-, styrenated",68442-68-2," Repeated dose toxicity: Subacute (28-day) study, oral: gavage, Sprague-Dawley rat m/f, 5/sex/dose, 0, 100, 300, 1000 mg/kg bw/d (OECD 407, GLP): NOAEL = 100 mg/kg bw/d (m/f), based on haematology, clinical biochemistry, gross pathology, histopathology Repeated dose toxicity: Subacute (6-7 week) study, oral: gavage, Sprague-Dawley rat m/f, 10/sex/dose, 0, 50, 250, 600 mg/kg bw/d (OECD 422, GLP): NOAEL = 600 mg/kg bw/d (systemic toxicity, only adaptive, non-adverse responses) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1815ac24-517c-46da-9eb2-e55d6d29b040/documents/e260805b-55eb-451a-8bbf-d7868de845f7_8d33633a-61ca-4dfa-9175-24019bcaa2f5.html,,,,,, "Benzenamine, N-phenyl-, styrenated",68442-68-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1815ac24-517c-46da-9eb2-e55d6d29b040/documents/e260805b-55eb-451a-8bbf-d7868de845f7_8d33633a-61ca-4dfa-9175-24019bcaa2f5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Benzenamine, N-phenyl-, styrenated",68442-68-2," Acute toxicity: Acute toxicity study oral (gavage), 10 male Wistar-II rats (similar to OECD 401): LD50 > 5000 mg/kg, LD0 ≥ 5000 mg/kg, no mortalities, no clinical symptoms on any observation day observed Acute toxicity: Acute toxicity study oral (gavage), 10 male Wistar-II rats, 50% solution (similar to OECD 401): LD50 > 5000 mg/kg, LD0 ≥ 5000 mg/kg, no mortalities, no clinical symptoms on any observation day observed Acute toxicity: Acute toxicity study dermal (neat, semiocclusive), Wistar rat m/f, 5/sex/dose (OECD 402, GLP): LD50 > 2000 mg/kg, LD0 ≥ 2000 mg/kg, no deaths occurred, no signs of systemic toxicity or dermal irritation were noted during the observation period. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1815ac24-517c-46da-9eb2-e55d6d29b040/documents/5d4560e9-01f6-4f93-a2d1-9c4ef633ed3a_8d33633a-61ca-4dfa-9175-24019bcaa2f5.html,,,,,, "Benzenamine, N-phenyl-, styrenated",68442-68-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1815ac24-517c-46da-9eb2-e55d6d29b040/documents/5d4560e9-01f6-4f93-a2d1-9c4ef633ed3a_8d33633a-61ca-4dfa-9175-24019bcaa2f5.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Benzenamine, N-phenyl-, styrenated",68442-68-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1815ac24-517c-46da-9eb2-e55d6d29b040/documents/5d4560e9-01f6-4f93-a2d1-9c4ef633ed3a_8d33633a-61ca-4dfa-9175-24019bcaa2f5.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Benzenamine, oxidized",13007-86-8,"- Combined repeated dose toxicity study with a reproduction / developmental toxicity screening: according to OECD 422, GLP, rat (m/f), oral (gavage), NOAEL for general systemic toxicity = 1000 mg/kg bw/d ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/221016dc-4b70-421d-aac8-ef73f41c4da5/documents/IUC5-f2d80a1b-3d7c-442c-ba5b-e625e8988b89_9f082375-d207-44b4-abaa-5cd09f882448.html,,,,,, "Benzenamine, oxidized",13007-86-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/221016dc-4b70-421d-aac8-ef73f41c4da5/documents/IUC5-f2d80a1b-3d7c-442c-ba5b-e625e8988b89_9f082375-d207-44b4-abaa-5cd09f882448.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Benzenamine, oxidized",13007-86-8,"- Oral: similar to OECD TG 401, pre-GLP, rat (m/f), LD50 >6400 mg/kg bw- Dermal: similar to OECD TG 402, pre-GLP, rat (m/f), LD50 >2500 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/221016dc-4b70-421d-aac8-ef73f41c4da5/documents/IUC5-65ef1a5b-0692-4dea-93ce-1ae6504ea0fe_9f082375-d207-44b4-abaa-5cd09f882448.html,,,,,, "Benzenamine, oxidized",13007-86-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/221016dc-4b70-421d-aac8-ef73f41c4da5/documents/IUC5-65ef1a5b-0692-4dea-93ce-1ae6504ea0fe_9f082375-d207-44b4-abaa-5cd09f882448.html,,oral,discriminating dose,"6,400 mg/kg bw",no adverse effect observed, "Benzenamine, oxidized",13007-86-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/221016dc-4b70-421d-aac8-ef73f41c4da5/documents/IUC5-65ef1a5b-0692-4dea-93ce-1ae6504ea0fe_9f082375-d207-44b4-abaa-5cd09f882448.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "Benzenamine, reaction products with aniline hydrochloride and nitrobenzene",101357-15-7," 28-Day Study: Wragg & Brooks (1994) A fully compliant 28-d toxicity study is available performed according to OECD guideline 407 (1995).  Toxicologically significant effects were observed at a dose level of 1000 mg/kg/day but not at the lower dose levels of 150 mg/kg/day and 15 mg/kg/day. 90-Day Study: Oroszlány (2019) Under the conditions of this study, the no observed adverse effect level (NOAEL) for the test material is considered to be 300 mg/kg bw/day for both sexes. The NOAEL of 300 mg/kg bw is taken forward as the dose descriptor since it is derived from a longer-term study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05b6cca5-6e13-4d5e-b08f-fe32d3a14824/documents/IUC5-9fb4c15a-0c64-438b-8a43-3a9f89c506db_1a5ffa27-be2f-4513-bd3b-4a44217b71a8.html,,,,,, "Benzenamine, reaction products with aniline hydrochloride and nitrobenzene",101357-15-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05b6cca5-6e13-4d5e-b08f-fe32d3a14824/documents/IUC5-9fb4c15a-0c64-438b-8a43-3a9f89c506db_1a5ffa27-be2f-4513-bd3b-4a44217b71a8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Benzenamine, reaction products with aniline hydrochloride and nitrobenzene",101357-15-7," Oral Route Key Study: Allen (1993) The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2 000 mg/kg bodyweight. Supporting Study: Walker (1992) The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 5 000 mg/kg bodyweight. Inhalation Route Key Study: Griffiths (2007) The acute inhalation median lethal concentration (4 hr LC50) of the test material, in the Sprague-Dawley Crl:CD (SD) IGS BR strain rat, was greater than 5.00 mg/L. Dermal Route Key Study: Walter (1992) The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2 000 mg/kg bodyweight. Supporting Study: Walker (1992) The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2 000 mg/kg bodyweight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05b6cca5-6e13-4d5e-b08f-fe32d3a14824/documents/IUC5-aecaa127-24f8-4f55-ae55-57078cc8fa7f_1a5ffa27-be2f-4513-bd3b-4a44217b71a8.html,,,,,, "Benzenamine, reaction products with aniline hydrochloride and nitrobenzene",101357-15-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05b6cca5-6e13-4d5e-b08f-fe32d3a14824/documents/IUC5-aecaa127-24f8-4f55-ae55-57078cc8fa7f_1a5ffa27-be2f-4513-bd3b-4a44217b71a8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzenamine, reaction products with aniline hydrochloride and nitrobenzene",101357-15-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05b6cca5-6e13-4d5e-b08f-fe32d3a14824/documents/IUC5-aecaa127-24f8-4f55-ae55-57078cc8fa7f_1a5ffa27-be2f-4513-bd3b-4a44217b71a8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzenamine, reaction products with aniline hydrochloride and nitrobenzene",101357-15-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05b6cca5-6e13-4d5e-b08f-fe32d3a14824/documents/IUC5-aecaa127-24f8-4f55-ae55-57078cc8fa7f_1a5ffa27-be2f-4513-bd3b-4a44217b71a8.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides",101357-16-8,"Key study: Test method according to OECD Guideline 413. GLP study. Based on the observed results, the NOAEC of the test item was found to be 5.0 mg/L when exposed for 6 hours/day for 90 days by flow-past nose-only inhalation route to Sprague Dawley rats. No detectable concentration of the test substance was observed in plasma and urine samples. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab4480f3-6437-4a20-906b-14393e5579b7/documents/IUC5-824e7c46-9a23-4031-b02e-462f4f708ec1_96afe826-0856-4680-8dbd-734e00ce0bae.html,,,,,, "Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides",101357-16-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab4480f3-6437-4a20-906b-14393e5579b7/documents/IUC5-824e7c46-9a23-4031-b02e-462f4f708ec1_96afe826-0856-4680-8dbd-734e00ce0bae.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,5 mg/L,,rat "Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides",101357-16-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab4480f3-6437-4a20-906b-14393e5579b7/documents/IUC5-824e7c46-9a23-4031-b02e-462f4f708ec1_96afe826-0856-4680-8dbd-734e00ce0bae.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,5 mg/L,,rat "Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides",101357-16-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The selected key study is GLP compliant and of high quality (Klimisch score = 1). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch 2. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab4480f3-6437-4a20-906b-14393e5579b7/documents/IUC5-d61ac2fc-551d-4bb5-83c9-8c9b472b01cf_96afe826-0856-4680-8dbd-734e00ce0bae.html,,,,,, "Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides",101357-16-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab4480f3-6437-4a20-906b-14393e5579b7/documents/IUC5-d61ac2fc-551d-4bb5-83c9-8c9b472b01cf_96afe826-0856-4680-8dbd-734e00ce0bae.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Benzenamine, reaction products with aniline hydrochloride and nitrobenzene, hydrochlorides",101357-16-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab4480f3-6437-4a20-906b-14393e5579b7/documents/IUC5-d61ac2fc-551d-4bb5-83c9-8c9b472b01cf_96afe826-0856-4680-8dbd-734e00ce0bae.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, ((3-(sec-butyl)-4-(decyloxy)phenyl)methanetriyl)tribenzene,1404190-37-9,The substance did not show any adverse effects in a dietary OECD 422 repeated dose/reproductive toxicity screening study at doses >1000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca2e9d10-6b43-4df8-bfed-b8f5e4f4394f/documents/IUC5-36feb80c-0f88-48a1-8b44-31778192cee7_dbf86baf-6cf2-4eca-a524-0646ae9e8217.html,,,,,, ((3-(sec-butyl)-4-(decyloxy)phenyl)methanetriyl)tribenzene,1404190-37-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca2e9d10-6b43-4df8-bfed-b8f5e4f4394f/documents/IUC5-36feb80c-0f88-48a1-8b44-31778192cee7_dbf86baf-6cf2-4eca-a524-0646ae9e8217.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat ((3-(sec-butyl)-4-(decyloxy)phenyl)methanetriyl)tribenzene,1404190-37-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): One High quality study on similar material available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca2e9d10-6b43-4df8-bfed-b8f5e4f4394f/documents/IUC5-09e873b5-5515-4eae-8614-5f6cf93d7ced_dbf86baf-6cf2-4eca-a524-0646ae9e8217.html,,,,,, "Benzene, 1,1'-oxybis-, tetrapropylene derivs., sulfonated, sodium salts",119345-04-9,"Several GLP and non-GLP studies containing sufficient data for the interpretation and assessment are available, including rat and dog studies on the REACH-registered substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): adequate Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): acceptable ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eda23f4f-8dae-4566-8a3e-cdaae1596213/documents/2c6db0f8-89a4-4a99-bb45-5dacd6ed9fe2_1bf2eeca-4833-47b6-90b9-c2e0df374382.html,,,,,, "Benzene, 1,1'-oxybis-, tetrapropylene derivs., sulfonated, sodium salts",119345-04-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eda23f4f-8dae-4566-8a3e-cdaae1596213/documents/2c6db0f8-89a4-4a99-bb45-5dacd6ed9fe2_1bf2eeca-4833-47b6-90b9-c2e0df374382.html,Chronic toxicity – systemic effects,oral,NOAEL,128 mg/kg bw/day,,dog "Benzene, 1,1'-oxybis-, tetrapropylene derivs., sulfonated, sodium salts",119345-04-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eda23f4f-8dae-4566-8a3e-cdaae1596213/documents/2c6db0f8-89a4-4a99-bb45-5dacd6ed9fe2_1bf2eeca-4833-47b6-90b9-c2e0df374382.html,Repeated dose toxicity – local effects,dermal,NOAEL,5.75 mg/cm2,no adverse effect observed,rabbit "Benzene, 1,1'-oxybis-, tetrapropylene derivs., sulfonated, sodium salts",119345-04-9," Acute oral and dermal toxicity data on the registered substance, DOWFAX 2A1, indicate that GHS criteria for classificaiton are not met. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eda23f4f-8dae-4566-8a3e-cdaae1596213/documents/ee543fc5-c046-4067-92fd-908117594037_1bf2eeca-4833-47b6-90b9-c2e0df374382.html,,,,,, "Benzene, 1,1'-oxybis[methyl-, sulfonated, ammonium salts",75314-26-0," There were no signs of systemic toxicity in selected male or female animals at 100, 300 or 1000 mg/kg bw/day. NOAEL for systemic toxicity of male/ female rats: 1000 mg/kg bw/day (preliminary results). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eea8f9c1-3569-4de2-8229-40197a4093f6/documents/884d6f3c-cf70-4722-9c34-0c46491f1bf5_a81e1d30-390e-4aec-9aa4-1e497452e1c3.html,,,,,, "Benzene, 1,1'-oxybis[methyl-, sulfonated, ammonium salts",75314-26-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eea8f9c1-3569-4de2-8229-40197a4093f6/documents/884d6f3c-cf70-4722-9c34-0c46491f1bf5_a81e1d30-390e-4aec-9aa4-1e497452e1c3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Benzene, 1,1'-oxybis[methyl-, sulfonated, ammonium salts",75314-26-0," Acute oral toxicity No signs of toxicity for the substance (preliminary result, study in progress). Based on available information (results from supporting studies) it is assumed that the acute oral median lethal dose (LD50) of Benzene, 1,1'-oxybis(methyl-, sulfonated, ammonium salts (CAS no. 75314 -26 -0), is greater than 2000 mg/kg bodyweight (not classified with oral acute toxicity according to the CLP regulation 1272/2008/EC). Acute inhalation toxicity The study concerning the acute inhalation toxicity does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Acute dermal toxicity The study concerning the acute dermal toxicity does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitation). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eea8f9c1-3569-4de2-8229-40197a4093f6/documents/4accae63-7a36-4682-a48e-247f837e6534_a81e1d30-390e-4aec-9aa4-1e497452e1c3.html,,,,,, 4-Chloro-3-(trifluoromethyl)phenyl isocyanate,327-78-6,"Acute oral toxicity, OECD TG 423, rat (Schüngel 2003, Report AT00838): 300> LD50 < 2000 mg/kg bw (LD50 cut-off, rat: 500 mg/kg bw)   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is GLP compliant and is of high quality (Klimisch score=1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/798c0320-6148-4da8-8193-273d84df8649/documents/IUC5-11838931-3d9e-4187-a83a-3d384e73d756_ce3bcb0f-2c6e-426d-8ddd-0daa51e843be.html,,,,,, 4-Chloro-3-(trifluoromethyl)phenyl isocyanate,327-78-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/798c0320-6148-4da8-8193-273d84df8649/documents/IUC5-11838931-3d9e-4187-a83a-3d384e73d756_ce3bcb0f-2c6e-426d-8ddd-0daa51e843be.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, "2-(chloromethyl)-1,3-difluorobenzene",697-73-4,No reliable data are available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/187781b9-f2af-4af1-a44d-72e6def9e173/documents/IUC5-95b1f857-4c71-4e6f-b005-b257f0f7351a_be2e9ff6-d150-45e1-b467-cb9892df5a36.html,,,,,, 4-bromo-1-chloro-2-[(4-éthoxyphenyl)(phenylmethoxy)-methyl]-benzene,1298086-15-3,"Oral:One 7-day study on rats is available which was conducted according to OECD 407 using rats (Beerens-Heijnen, 2015). The no-observed-adverse-effect-level (NOAEL) for this study is 1000 mg/kg. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/388d9863-7ce1-45fa-9194-53103ca53206/documents/IUC5-dc841000-e6db-4330-9945-66cbb63e6df5_8d9c7b29-8d41-4d6f-8881-781650a97db2.html,,,,,, 4-bromo-1-chloro-2-[(4-éthoxyphenyl)(phenylmethoxy)-methyl]-benzene,1298086-15-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/388d9863-7ce1-45fa-9194-53103ca53206/documents/IUC5-dc841000-e6db-4330-9945-66cbb63e6df5_8d9c7b29-8d41-4d6f-8881-781650a97db2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-bromo-1-chloro-2-[(4-éthoxyphenyl)(phenylmethoxy)-methyl]-benzene,1298086-15-3,"Oral:One study on rats is available.LD50 in rat was higher than 2000 mg/kg body weight (not disclosed, 2014). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/388d9863-7ce1-45fa-9194-53103ca53206/documents/IUC5-b561844d-bc09-4b73-99ac-f6ea82e57afd_8d9c7b29-8d41-4d6f-8881-781650a97db2.html,,,,,, 4-bromo-1-chloro-2-[(4-éthoxyphenyl)(phenylmethoxy)-methyl]-benzene,1298086-15-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/388d9863-7ce1-45fa-9194-53103ca53206/documents/IUC5-b561844d-bc09-4b73-99ac-f6ea82e57afd_8d9c7b29-8d41-4d6f-8881-781650a97db2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzene, C10-13-alkyl derivs.",67774-74-7," Read-across to 109-d OECD TG 416 study in rats, NOAEL: 50 mg/kg bw/d; Read-across to 28-d OECD TG 407 equivalent study in rats, LOAEL: 125 mg/kg bw ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b859cc4f-5c8b-46c8-8585-03b3a46d7f63/documents/IUC5-6e8311a8-3d9b-41ca-a8c9-5418d75209be_1d572e27-c047-4eb0-a419-a1bc5abbfc63.html,,,,,, "Benzene, C10-13-alkyl derivs.",67774-74-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b859cc4f-5c8b-46c8-8585-03b3a46d7f63/documents/IUC5-6e8311a8-3d9b-41ca-a8c9-5418d75209be_1d572e27-c047-4eb0-a419-a1bc5abbfc63.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Benzene, C10-13-alkyl derivs.",67774-74-7," The oral LD50 is >5000 mg/kg bw (highest tested concentration) in rats (OECD 401, under GLP) The dermal LD50 is > 2000 mg/kg bw (highest tested concentration) in rats (OECD 402, under GLP) Acute toxicity studies in rats via the oral and dermal exposure routes resulted in no mortality or other signs of toxicity at the limit doses, therefore no classification for acute toxicity is warranted. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b859cc4f-5c8b-46c8-8585-03b3a46d7f63/documents/IUC5-84f5c712-a4d0-4591-b5d5-9096a22306bf_1d572e27-c047-4eb0-a419-a1bc5abbfc63.html,,,,,, "Benzene, C10-13-alkyl derivs.",67774-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b859cc4f-5c8b-46c8-8585-03b3a46d7f63/documents/IUC5-84f5c712-a4d0-4591-b5d5-9096a22306bf_1d572e27-c047-4eb0-a419-a1bc5abbfc63.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Benzene, C10-13-alkyl derivs.",67774-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b859cc4f-5c8b-46c8-8585-03b3a46d7f63/documents/IUC5-84f5c712-a4d0-4591-b5d5-9096a22306bf_1d572e27-c047-4eb0-a419-a1bc5abbfc63.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzene, C9-13-alkyl derivs., distn. residues, sulfonated, calcium salts",97675-24-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7e54787-ee21-448f-b762-5df075e4712a/documents/IUC5-4974f397-83d7-4f31-82c1-a3a0f2ebfd38_5ee88972-35d2-4d21-b28e-83a62d370ff5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Benzene, C9-13-alkyl derivs., distn. residues, sulfonated, calcium salts",97675-24-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7e54787-ee21-448f-b762-5df075e4712a/documents/IUC5-4974f397-83d7-4f31-82c1-a3a0f2ebfd38_5ee88972-35d2-4d21-b28e-83a62d370ff5.html,Short-term repeated dose toxicity – systemic effects,dermal,LOAEL,250 mg/kg bw/day,,rabbit "Benzene, C9-13-alkyl derivs., distn. residues, sulfonated, calcium salts",97675-24-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7e54787-ee21-448f-b762-5df075e4712a/documents/IUC5-4974f397-83d7-4f31-82c1-a3a0f2ebfd38_5ee88972-35d2-4d21-b28e-83a62d370ff5.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,49.5 mg/m3,,rat "Benzene, C9-13-alkyl derivs., distn. residues, sulfonated, calcium salts",97675-24-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7e54787-ee21-448f-b762-5df075e4712a/documents/IUC5-4974f397-83d7-4f31-82c1-a3a0f2ebfd38_5ee88972-35d2-4d21-b28e-83a62d370ff5.html,Repeated dose toxicity – local effects,inhalation,NOAEC,49.5 mg/m3,adverse effect observed,rat "Benzene, C9-13-alkyl derivs., distn. residues, sulfonated, calcium salts",97675-24-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7e54787-ee21-448f-b762-5df075e4712a/documents/IUC5-b85f6bea-632b-494f-a7d6-1f359dbdef04_5ee88972-35d2-4d21-b28e-83a62d370ff5.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Benzene, C9-13-alkyl derivs., distn. residues, sulfonated, calcium salts",97675-24-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7e54787-ee21-448f-b762-5df075e4712a/documents/IUC5-b85f6bea-632b-494f-a7d6-1f359dbdef04_5ee88972-35d2-4d21-b28e-83a62d370ff5.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Benzene, C9-13-alkyl derivs., distn. residues, sulfonated, calcium salts",97675-24-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7e54787-ee21-448f-b762-5df075e4712a/documents/IUC5-b85f6bea-632b-494f-a7d6-1f359dbdef04_5ee88972-35d2-4d21-b28e-83a62d370ff5.html,,inhalation,discriminating conc.,"1,900 mg/m3",no adverse effect observed, "Benzene, di-C10-14-alkyl derivs., sulfonated, sodium salts",85117-37-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95d6fa11-43a1-4f93-83da-138089f32ff8/documents/d6808622-8a59-4cfa-9c5c-23c89c0e4851_f13fc749-827c-493e-bdf1-49804969bcf4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzene, dibromoethyl Benzene, ethenyl-, ar-bromo derivs.",125904-11-2,"A 90-day study, groups of 20 male and female rats received daily dosages of 130, 300, 700 or 1600 mg/kg bw/day by gavage. The control group received the vehicle, corn oil, at 5 mL/kg bw. Five rats/sex/group remained on study following the dosing period for a 30 -day recovery period.Decreased male body weight and body weight gain was noted at 1600 mg/kg bw/day and increased food consumption in both sexes at 1600 mg/kg bw/day and in males at 700 mg/kg bw/day. Transitory haematologic changes, possibly compensatory increased red blood cell production were noted at the 30 -day evaluation in both sexes at 1600 mg/kg bw/day and, to a much lesser extent in the 300 and 700 mg/kg bw/day groups; some evidence of these haematologic changes persisted to the 90 -day evaluation at the highest dose level. Treatment-related hypoglycaemia was present in the 300, 700 and 1600 mg/kg bw/day groups. Serum bromide and tissue bromine levels were increased in all groups, generally in a dose-related pattern, at 90 -day sacrifice. Test material-related liver weight increases were observed in the 700 and 1600 mg/kg bw/day females at the 90 -day sacrifice. Microscopic liver changes indicative of increased detoxification requirement were present in the 700 and 1600 mg/kg bw/day animals. Kidney and possibly urinary bladder changes were also observed in the 1600 mg/kg bw/day group.Essentially all toxicity subsided by the end of the recovery period. No biologically significant differences between the control and treated groups in body weight, body weight gain, food consumption, haematology or serum chemistry values or microscopic pathology findings were apparent for recovery animals. Increased liver weights in females treated at 1600 mg/kg bw/day persisted to the end of recovery, however, the magnitude of the increase was less than at the 90 -day sacrifice, and no microscopic findings accompanied this.130 mg/kg bw/day was found to be the No Observable Effect Level (NOEL) for systemic toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/824a45d2-65e8-4085-9c4b-99f0939fa5f1/documents/434d4246-2ef0-4441-9c13-965173af16a3_c9383af0-0cf5-4788-87d7-7f57d0b791f2.html,,,,,, "Benzene, dibromoethyl Benzene, ethenyl-, ar-bromo derivs.",125904-11-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/824a45d2-65e8-4085-9c4b-99f0939fa5f1/documents/434d4246-2ef0-4441-9c13-965173af16a3_c9383af0-0cf5-4788-87d7-7f57d0b791f2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,130 mg/kg bw/day,,rat "Benzene, dibromoethyl Benzene, ethenyl-, ar-bromo derivs.",125904-11-2," Oral: The test substance was found to be practically non-toxic by the oral route of exposure, with a LD50 value of 6327 mg/kg bw for both sexes combined. Dermal: No signs of systemic toxicity were noted. Evaluation of local skin reactions revealed severe to slight erythema and oedema (10/10), mild to slight scaling (10/10), abraded lines well defined (2/10), atonia (1/10), haemorrhaged area (2/10) and compound residues (10/10). Individual and mean body weights increased at each recoding time following dosing. The acute dermal LD50 of dibromostyrene was greater than 2000 mg/kg bw. Inhalation: The study provided in this section was provided for information purposes only, and was not included for use in assessment of the toxicity of the substance. Reactions during exposure included lacrimation, clear nasal discharge, inactivity, and rapid, shallow breathing. All animals appeared normal in the afternoon following exposure and during the 2-day observation period. The LC50 of the study was determined to be greater than the highest dose tested. No necropsy data was provided. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/824a45d2-65e8-4085-9c4b-99f0939fa5f1/documents/9d04f4c0-c55a-4fae-9215-b34fbcb24a78_c9383af0-0cf5-4788-87d7-7f57d0b791f2.html,,,,,, "Benzene, dibromoethyl Benzene, ethenyl-, ar-bromo derivs.",125904-11-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/824a45d2-65e8-4085-9c4b-99f0939fa5f1/documents/9d04f4c0-c55a-4fae-9215-b34fbcb24a78_c9383af0-0cf5-4788-87d7-7f57d0b791f2.html,,oral,LD50,"6,327 mg/kg bw",no adverse effect observed, "Benzene, ethylenated, residues",68987-42-8,"Repeated dose toxicity data are not available for Fuel Oils streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene - when present at 10%). The available data on the marker constituent DCPD do not reveal any specific target organ toxicity of a severity that would warrant classification. Therefore, no classification or labelling is warranted for streams which only contain these components. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3605b841-6545-4d02-a5ef-e686bf667148/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_803cbcc8-4a4e-4c05-89ad-0271ac5e5860.html,,,,,, "Benzene, ethylenated, residues",68987-42-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3605b841-6545-4d02-a5ef-e686bf667148/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_803cbcc8-4a4e-4c05-89ad-0271ac5e5860.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Benzene, ethylenated, residues",68987-42-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3605b841-6545-4d02-a5ef-e686bf667148/documents/IUC5-23a7fe01-2f5d-406e-b63b-78474dca5794_803cbcc8-4a4e-4c05-89ad-0271ac5e5860.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Benzene, ethylenated, residues",68987-42-8,"Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen.The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene.   Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene.   Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene. Available data for 4 specific streams within this category CAS 64742-90-1, CAS 68475-80-9, CAS 85117-10-8, CAS 98072-36-7, and on specific components (benzene, toluene, dicyclopentadiene, ethylbenzene, styrene, and naphthalene) that are present in some streams indicate that acute toxicity is expected to be low. The oral and dermal LD50 is > 2000 mg/kg for all tested streams and the inhalation 7h LC50 is >1.6 mg/L (exposure duration was longer than required by the guideline and in the absence of any evidence of toxicity at this concentration it is considered that the tested streams are not toxic). Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (H336) will be required for streams containing ≥20% toluene. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3605b841-6545-4d02-a5ef-e686bf667148/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_803cbcc8-4a4e-4c05-89ad-0271ac5e5860.html,,,,,, "Benzene, ethylenated, residues",68987-42-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3605b841-6545-4d02-a5ef-e686bf667148/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_803cbcc8-4a4e-4c05-89ad-0271ac5e5860.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzene, ethylenated, residues",68987-42-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3605b841-6545-4d02-a5ef-e686bf667148/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_803cbcc8-4a4e-4c05-89ad-0271ac5e5860.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzene, ethylenated, residues",68987-42-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3605b841-6545-4d02-a5ef-e686bf667148/documents/IUC5-2c1df3da-428a-4c13-b3bc-853724181245_803cbcc8-4a4e-4c05-89ad-0271ac5e5860.html,,inhalation,LC50,"1,600 mg/m3",no adverse effect observed, "Benzene, ethylenated residues, distn lights. the light ends from the distillation of high boiling polyethyl benzene residues, produced from the manufacture and distillation of ethylbenzene, boiling in the range of 200-238 degrees c.",178535-25-6,"An acute oral toxicity study was carried out according to OECD guideline 423 and Eu method B13/14. A group of five female and male Sprague-Dawley rats were administered a single oral dose of Ethylbenzene, manuf. of, distn. residues, distn. lights., suspended in distilled water. No death were reported during the course of the study. Clinical signs such as light purple coloured urine and brown staining to the muzzle were noted. All animals had recovered on day 4 after dosing.Acute oral toxicity:LD50 > 2000 mg/kg bw for rat (limit test) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c14da09d-fe52-4538-a3ae-1c2248e705ee/documents/IUC5-394ff000-9956-4736-99de-057c996b16b0_20dbceab-ed64-4328-acc2-056d4e2b9ef6.html,,,,,, "Benzene, ethylenated residues, distn lights. the light ends from the distillation of high boiling polyethyl benzene residues, produced from the manufacture and distillation of ethylbenzene, boiling in the range of 200-238 degrees c.",178535-25-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c14da09d-fe52-4538-a3ae-1c2248e705ee/documents/IUC5-394ff000-9956-4736-99de-057c996b16b0_20dbceab-ed64-4328-acc2-056d4e2b9ef6.html,,oral,LD50,"2,000 mg/kg bw",, "Benzene, mono C10-13-alkyl derivs., fractionation bottoms, heavy ends, sulfonated, sodium salts",148520-82-5," Repeated dose toxicity - oral: No key repeated dose toxicity study with the target substance is available. Data from the supporting substance LABS Na was used to cover this endpoint. In a 28days repeated dose toxicity, LABS Na was dosed in male and female Sprague-Dawley rats via oral gavage at doses up to 500 mg/kg bw/day. The NOAEL and LOAEL were set at 125 and 250 mg/kg bw/day, respectively. In the key chronic toxicity study, LABS Na was dosed daily via diet during 6 months. The NOAEL and LOAEL were set at 40 and 115 mg/kg bw/day, respectively. Repeated dose toxicity - inhalation: No key repeated dose toxicity study via inhalation administration is available. Repeated dose toxicity - dermal: No key repeated dose toxicity study via dermal administration is available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b215d0dd-0bf4-4c2b-ba9b-371ecd1b8dc9/documents/8c677196-0088-4457-99e8-b2288381c15e_c551000f-2957-4d90-a70e-94b263cb14fe.html,,,,,, "Benzene, mono C10-13-alkyl derivs., fractionation bottoms, heavy ends, sulfonated, sodium salts",148520-82-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b215d0dd-0bf4-4c2b-ba9b-371ecd1b8dc9/documents/8c677196-0088-4457-99e8-b2288381c15e_c551000f-2957-4d90-a70e-94b263cb14fe.html,Chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat "Benzene, mono C10-13-alkyl derivs., fractionation bottoms, heavy ends, sulfonated, sodium salts",148520-82-5,"No acute toxicity data of the target substance is available. Data from the supporting substance LABS Na is used to cover this endpoint. One key and 3 supporting studies are identified. In the key, K2 study, performed according to OECD guideline 401, an LD50 of 1080 mg/kg was established in male and female rats. In one key dermal acute toxicity study, the LD50 was set at >2000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b215d0dd-0bf4-4c2b-ba9b-371ecd1b8dc9/documents/b4c60db9-a238-4998-9d9f-d32e9c25dc5d_c551000f-2957-4d90-a70e-94b263cb14fe.html,,,,,, "Benzene, mono C10-13-alkyl derivs., fractionation bottoms, heavy ends, sulfonated, sodium salts",148520-82-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b215d0dd-0bf4-4c2b-ba9b-371ecd1b8dc9/documents/b4c60db9-a238-4998-9d9f-d32e9c25dc5d_c551000f-2957-4d90-a70e-94b263cb14fe.html,,oral,LD50,"1,080 mg/kg bw",adverse effect observed, "Benzene, mono C10-13-alkyl derivs., fractionation bottoms, heavy ends, sulfonated, sodium salts",148520-82-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b215d0dd-0bf4-4c2b-ba9b-371ecd1b8dc9/documents/b4c60db9-a238-4998-9d9f-d32e9c25dc5d_c551000f-2957-4d90-a70e-94b263cb14fe.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzene, mono-C10-13-alkyl derivs., distn. residues",84961-70-6," Two key studies determined the sub-chronic toxicity of HAB to rats. In the first study (Charles River 2007), groups of rats were exposed by oral gavage to concentrations of 0, 250, 500 or 1000 mg/kg/day of test substance. Males were exposed daily for 39 days, and females were exposed daily through lactation day 4. Animals were observed regularly for body weight, mortality, clinical signs, food consumption, and behaviour. At the end of the study, the animals were sacrificed and examined for gross pathology, organ weights, histopathology, clinical chemistry, hematology, and urinalysis parameters. Adverse effects were seen in the thymus at all dose levels, however, these changes are most likely stress related and are considered to be of minimal toxicological significance. Body weight reduction was seen in male rats at the 1000 mg/kg/day dose level. Thus, the LOAEL for male rats was determined to be 1000 mg/kg/day, making the NOAEL 500 mg/kg/day. No adverse effects were seen in female rats, therefore, the NOAEL for female rats is 1000 mg/kg/day.  The following summarizes the details of the results: Mortality: No treatment-related mortalities were observed. One early sacrifice occurred in one male rat as the result of an injury. No treatment-related clinical signs were observed in the F0 male and female rats and F1 generation rats (main and recovery portions of the study). Body Weight: Body weight gains of the male rats assigned to the main study were significantly reduced for the entire study (DSs 1 to 39) in the 1000 mg/kg/day dosage group. No reductions in body weight or body weight gain was observed in the male rats assigned to the recovery portion as high as 1000 mg/kg/day. No effects on body weight or body weight gain were observed in the female rats during any stage of the study at doses up to and including 1000 mg/kg/day. Feed Consumption: No effects were observed on the absolute or relative feed consumption for either sex a high as 1000 mg/kg/day. Reproduction: No effects were observed on estrous, mating, fertility, natural delivery or litter observations at any dose. Behavior and Motor Activity: No effects on any of the parameters examined in the FOB, motor activity or urinalysis were observed. Clinical Chemistry: There were no statistically significant or biologically important differences in the urinalysis, haematology or clinical chemistry parameters. Organ Weights: No statistically significant differences were observed in organ weights, the ratio (%) of organ weights to terminal body weights, or the ratio (%) of organ weights to brain weights in either sex at any dose. Microscopic Effects: Treatment-related microscopic changes were observed in the thyroid of male and female rats at all dosage levels and in the thymus of the 1000 mg/kg/day dosage group female rats. No other treatment-related microscopic changes were observed. The changes in the thyroid consisted of hyperplasia and hypertrophy of the follicular epithelial cells. These microscopic changes occurred in a dose-responsive manner. According to various sources, the thyroid of rats is susceptible to environmental variations that are reversible and considered of minimal toxicological significance. Thyroid changes may be a response to stress, and therefore, a combination of dosing and stress may have contributed to the effects seen in this study (e.g., Cotchin and Roe 1967; Haschek and Rousseaux 1991). Microscopically, the thymus was reduced in size due to atrophy of the cortical and medullary lymphoid lobules in the 1000 mg/kg/day dosage group (females only). No atrophy was observed in the males of any dosage group or the females in the 250 and 500 mg/kg/day groups. Thymic atrophy or decreased cellularity is a relatively nonspecific finding in young rats, but is often associated with stress and can occur in young rats with significant decreased weight gain or loss. In the second key study (Naylor and Ruecker 1988), a 90-day rat oral toxicity test to determine the effects of dietary exposure to the test substance was done. Groups of 20 male and female rats were fed diets containing 0, 1000, 8000, or 20,000 ppm (corresponding to 0, 45, 360 and 900 mg/kg bw/day) of test substance for 90 days. During the exposure period, the animals were observed for mortality, clinical signs, body weight, and food consumption. At 45 days, and at the end of the study at 90 days, blood samples were drawn and analyzed for hematological and clinical chemistry parameters. At the study termination at day 90, the animals were sacrificed and examined for gross pathology and histopathology. There were no treatment related deaths or clinical signs. There was reduced weight gain in middle and high dose females, and high dose males. Middle and high dose females had increased liver weights, and middle and high dose males had increased kidney weights. Based on these effects the LOAEL for both males and females was 8000 ppm. The NOAEL for both males and females was 1000 ppm.  Additional details of the results: Clinical signs and mortality: There was no mortality, and no treatment related clinical signs observed during the study. Body weight and weight gain: There was reduced weight gain in middle and high dose females. The body weights of these females were significantly lower by the end of the study. High dose males also had reduced body weight gain. Food consumption: Females at the middle and high dose levels, and males at the high dose level exhibited decreased food consumption during the first week. The food consumption of these animals improved, but remained low throughout the study. Ophthalmoscopic examination: No treatment related effects were observed. Haematology: Mean corpuscular volume was decreased in high and middle dose females at the terminal sampling. Platelet counts were slightly increased in these groups at both samplings. No other treatment related effects were seen. There were no treatment related effects in males. Clinical chemistry: High dose males and females showed a slight decrease in total protein due to slight decreases in albumin and/or globin at the terminal sampling. Cholesterol was decreased in high dose males at the terminal sampling, and high dose females in the interim sampling. Glucose was slightly decreased in middle and high dose females at both samplings. Organ weights: Absolute and relative kidney weights were increased in middle and high dose males. Absolute and relative liver weights were increased in middle and high dose females. No other treatment related effects were observed. Gross pathology: No gross changes attributable to treatment were observed. Histopathology: Non-neoplastic: No histophathological changes attributable to treatment were observed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1716b95d-0990-4cf8-b474-3cae4d650bf9/documents/83157e1b-cb0b-4a9c-ad09-6a943e5a46d6_fd065007-de25-4fe4-892c-d0c730c48571.html,,,,,, "Benzene, mono-C10-13-alkyl derivs., distn. residues",84961-70-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1716b95d-0990-4cf8-b474-3cae4d650bf9/documents/83157e1b-cb0b-4a9c-ad09-6a943e5a46d6_fd065007-de25-4fe4-892c-d0c730c48571.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,45 mg/kg bw/day,,rat "Benzene, mono-C10-13-alkyl derivs., distn. residues",84961-70-6," Acute Oral Toxicity The key study examined the acute oral toxicity of Benzene, mono-C10-13-alkyl derivs., distn. residues (HAB) to rats. A group of 5 male and 5 female rats were given a dose of 2000 mg/kg bw test substance. The animals were examined for clinical symptoms and mortality at 0.5, 1, 2, 3, 4, 5, and 6 hours after application, and then once a day for two weeks. Body weight of the animals was determined on days 0, 7, and 14 of the study. After 14 days, the animals were sacrificed with carbon dioxide and examined macroscopically for recognizable organ defects. No mortality was observed during the study. No adverse effects to body weight or clinical signs were noted. The acute oral LD50 for male and female rats was > 2000 mg/kg bw. Acute Dermal Toxicity The key study examined the acute dermal toxicity of Benzene, mono-C10-13-alkyl derivs., distn. residues (HAB). Groups of five male and five female rats were exposed dermally to concentrations of 0 and a limit dose of either 3600 (males) or 4300 mg/kg bw (females). Animals were observed for the next 14 days for mortality and clinical signs and also weighed every 7 days. At the end of the study, animals were necropsied. No mortality was observed during the study, and no adverse clinical signs were noted. Body weight gains of treated animals were also comparable to controls. Doses up to 4300 mg/kg did not cause death or produce clinical, behavioral, or anatomical alterations in female rats. Doses up to 3600 mg/kg bw did not produce adverse effects in male rats. Therefore, the acute dermal LD50 for female rats was > 4300 mg/kg bw, and male rats was > 3600 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1716b95d-0990-4cf8-b474-3cae4d650bf9/documents/4753906c-0cba-4c52-89ea-2c232278b74e_fd065007-de25-4fe4-892c-d0c730c48571.html,,,,,, "Benzene, mono-C10-13-alkyl derivs., distn. residues",84961-70-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1716b95d-0990-4cf8-b474-3cae4d650bf9/documents/4753906c-0cba-4c52-89ea-2c232278b74e_fd065007-de25-4fe4-892c-d0c730c48571.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzene, mono-C10-13-alkyl derivs., distn. residues",84961-70-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1716b95d-0990-4cf8-b474-3cae4d650bf9/documents/4753906c-0cba-4c52-89ea-2c232278b74e_fd065007-de25-4fe4-892c-d0c730c48571.html,,dermal,LD50,"3,600 mg/kg bw",no adverse effect observed, "Benzene, mono-C10-13-alkyl derivs., fractionation bottoms, heavy ends, sulfonated",148520-81-4," The registered substance is classified as corrosive to skin (Cat 1C), therefore testing for acute toxicity via the oral, dermal and inhalation route is waived. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6d1b938-68d8-433d-906d-14952b6d94cf/documents/33cbe1e0-ea26-4188-a2e6-1c405fd15f07_4dd40930-8841-4e23-826c-6f5400dec17e.html,,,,,, "Benzene, mono-C10-14-alkyl derivs., fractionation bottoms, intermediate cut, sulfonated, sodium salts",85117-47-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b297382-52bd-4328-a4bd-539225e591d8/documents/IUC5-3548e262-eddc-4f56-9dea-8d4b6bee5811_c5c029d4-0771-4058-8956-22130a744632.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Benzene, mono-C10-14-alkyl derivs., fractionation bottoms, intermediate cut, sulfonated, sodium salts",85117-47-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b297382-52bd-4328-a4bd-539225e591d8/documents/IUC5-3548e262-eddc-4f56-9dea-8d4b6bee5811_c5c029d4-0771-4058-8956-22130a744632.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rabbit "Benzene, mono-C10-14-alkyl derivs., fractionation bottoms, intermediate cut, sulfonated, sodium salts",85117-47-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b297382-52bd-4328-a4bd-539225e591d8/documents/IUC5-3548e262-eddc-4f56-9dea-8d4b6bee5811_c5c029d4-0771-4058-8956-22130a744632.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,881.58 mg/m3,,rat "Benzene, mono-C10-14-alkyl derivs., fractionation bottoms, intermediate cut, sulfonated, sodium salts",85117-47-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b297382-52bd-4328-a4bd-539225e591d8/documents/IUC5-3548e262-eddc-4f56-9dea-8d4b6bee5811_c5c029d4-0771-4058-8956-22130a744632.html,Repeated dose toxicity – local effects,dermal,NOAEL,5.13 mg/cm2,adverse effect observed,other:Human voluntary and laboratory species "Benzene, mono-C10-14-alkyl derivs., fractionation bottoms, intermediate cut, sulfonated, sodium salts",85117-47-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b297382-52bd-4328-a4bd-539225e591d8/documents/IUC5-3548e262-eddc-4f56-9dea-8d4b6bee5811_c5c029d4-0771-4058-8956-22130a744632.html,Repeated dose toxicity – local effects,inhalation,NOAEC,881.58 mg/m3,adverse effect observed,rat "Benzene, mono-C10-14-alkyl derivs., fractionation bottoms, intermediate cut, sulfonated, sodium salts",85117-47-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b297382-52bd-4328-a4bd-539225e591d8/documents/IUC5-6799a0bc-4f4a-4379-9f05-71f4a50ab7dc_c5c029d4-0771-4058-8956-22130a744632.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Benzene, mono-C10-14-alkyl derivs., fractionation bottoms, intermediate cut, sulfonated, sodium salts",85117-47-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b297382-52bd-4328-a4bd-539225e591d8/documents/IUC5-6799a0bc-4f4a-4379-9f05-71f4a50ab7dc_c5c029d4-0771-4058-8956-22130a744632.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Benzene, mono-C10-14-alkyl derivs., fractionation bottoms, intermediate cut, sulfonated, sodium salts",85117-47-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b297382-52bd-4328-a4bd-539225e591d8/documents/IUC5-6799a0bc-4f4a-4379-9f05-71f4a50ab7dc_c5c029d4-0771-4058-8956-22130a744632.html,,inhalation,discriminating conc.,"1,900 mg/m3",no adverse effect observed, "Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:1)",54553-90-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e12773da-ec81-486d-a99a-51fb4d314dcc/documents/dfee2a89-949e-4056-9e67-6f2e18920696_9fcb4881-25f2-4a7e-8d81-d655309d28bf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:1)",54553-90-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e12773da-ec81-486d-a99a-51fb4d314dcc/documents/9ab8aeaa-6585-4fe5-ab1e-2d3813d4082f_9fcb4881-25f2-4a7e-8d81-d655309d28bf.html,,oral,LD50,"7,400 mg/kg bw",adverse effect observed, "Benzene-1,2,4,5-tetracarboxylic acid, compound with 4,5-dihydro-2-phenyl-1H-imidazole (1:2)",54553-91-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9f7cf61-d113-4975-a616-5a394a7f483b/documents/f65e052b-a5e9-4aa5-b332-5a7f50bf370c_54ff3cd1-29d5-4f5f-88a2-d5153ea1e5ff.html,,oral,LD50,980 mg/kg bw,adverse effect observed, "Benzene-1,2,4-tricarboxylic acid 1,2-anhydride, oligomeric reaction products with ethane- l,2-diol",43011-20-7,"Local respiratory sensitisation, but no systemic toxicity, is observed in rats after subchronic or chronic exposure of various cyclic acid anhydrides. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74de8f70-987e-46bb-803d-c0adab73de20/documents/IUC5-b60bfe4a-a029-4a91-8900-c170ec369172_d37d8946-0aaf-46a7-960f-176e3a99e1b6.html,,,,,, "Benzene-1,2,4-tricarboxylic acid 1,2-anhydride, oligomeric reaction products with ethane- l,2-diol",43011-20-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74de8f70-987e-46bb-803d-c0adab73de20/documents/IUC5-b60bfe4a-a029-4a91-8900-c170ec369172_d37d8946-0aaf-46a7-960f-176e3a99e1b6.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,294 ,, "Benzene-1,2,4-tricarboxylic acid 1,2-anhydride, oligomeric reaction products with ethane- l,2-diol",43011-20-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74de8f70-987e-46bb-803d-c0adab73de20/documents/IUC5-b60bfe4a-a029-4a91-8900-c170ec369172_d37d8946-0aaf-46a7-960f-176e3a99e1b6.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Benzene-1,2,4-tricarboxylic acid 1,2-anhydride, oligomeric reaction products with ethane- l,2-diol",43011-20-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74de8f70-987e-46bb-803d-c0adab73de20/documents/IUC5-b60bfe4a-a029-4a91-8900-c170ec369172_d37d8946-0aaf-46a7-960f-176e3a99e1b6.html,Repeated dose toxicity – local effects,inhalation,LOAEC,3 ,adverse effect observed, "Benzene-1,2,4-tricarboxylic acid 1,2-anhydride, oligomeric reaction products with ethane- l,2-diol",43011-20-7,The substance is not classified for oral or dermal toxicity. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74de8f70-987e-46bb-803d-c0adab73de20/documents/IUC5-b416f787-e057-4360-8f06-fba99e076ef3_d37d8946-0aaf-46a7-960f-176e3a99e1b6.html,,,,,, "Benzene-1,2,4-tricarboxylic acid 1,2-anhydride, oligomeric reaction products with ethane- l,2-diol",43011-20-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74de8f70-987e-46bb-803d-c0adab73de20/documents/IUC5-b416f787-e057-4360-8f06-fba99e076ef3_d37d8946-0aaf-46a7-960f-176e3a99e1b6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzene-1,2,4-tricarboxylic acid 1,2-anhydride, oligomeric reaction products with ethane- l,2-diol",43011-20-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74de8f70-987e-46bb-803d-c0adab73de20/documents/IUC5-b416f787-e057-4360-8f06-fba99e076ef3_d37d8946-0aaf-46a7-960f-176e3a99e1b6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzene-1,2:4,5-tetracarboxylic dianhydride",89-32-7," Repeat dose oral toxicity PDMA was administered by gavage to three groups, each of three male and three female Wistar rats, for 14 consecutive days, at dose levels of 250, 750 and 1000 mg/kg bw/day. A control group of was dosed with vehicle alone. There were no unscheduled deaths. And no clinically observable signs of toxicity were detected. Reduced body weight gains/body weight losses were evident for males treated with 1000 and 750 mg/kg bw/day. Females were unaffected by treatment at any level tested. No adverse effects on food or water consumption were detected and there were no macroscopic changes were detected at terminal kill. A NOAEL of 250 mg/kg bw/day for males was derived and a NOAEL of greater than 1000 mg/kg bw/day for the females.   Sub-chronic studies in the rat and mouse Phthalic anhydride (a close structural analogue of PDMA) was administered in the diet to either rats or mice for seven weeks. The dosages for rats were: 0, 410, 830, 1670 or 3300 mg/kg bw/day. And for mice were: 0, 890, 1790, 3570 or 7140 mg/kg bw/day. In the rat, phthalic anhydride at dosages up to 3300 mg/kg bw/day (50,000 ppm) was well tolerated with no overt adverse toxicity evident. However, phthalic anhydride had a NOAEL of 1670 mg/kg bw/day (25000 ppm) based on body weight performance. In the mouse, phthalic anhydride at dosages up to 7140 mg/kg bw/day (50,000 ppm) was well tolerated with no adverse toxicity evident which is considered at the NOAEL in this study. Chronic studies in the rat and mouse Phthalic anhydride (a close structural analogue of PDMA) was administered in the diet to either rats or mice for 104-105 weeks. The dosages for rats were: 0 (control), 7500 or 15000 ppm (approx. 0, 500, 1000 mg/kg bw/day); for mice were 0, 12500 or 25000 ppm (approx. 0, 1717or 3430 mg/kg bw/day). In the rat, phthalic anhydride at dosages up to 1000 mg/kg bw/day was well tolerated with no overt adverse toxicity evident. However, phthalic anhydride had a NOAEL of 500 mg/kg bw/day based on body weight performance at 1000 mg/kg bw/day. In the mouse, phthalic anhydride at dosages up to 3430 mg/kg bw/day was reasonably well tolerated. However, body weight deficits were evident at both dosages and so the LOAEL was 2340 mg/kg bw/day for the males and was 1717 mg/kg bw/day for the females.   Supporting study 1000 mg/kg of pyromellitic dianhydride as a 20 per cent suspension in peanut oil, was administered to each of six male albino rats, five times a week for two weeks. Other than a mild slowing of the growth rate, it was reported that no clinical signs of toxicity were observed. Three animals were sacrificed four hours after the tenth treatment, and the remaining three, ten days later. Microscopic examination of the tissues revealed chronic gastritis in the case of the first three rats, and no pathology in the last three.   Two-week inhalation study Rats exposed to dust atmospheres of pyromellitic dianhydride for 6 hours per day for a total of 10 exposures in 2 weeks (nominal: 0.01. 0.03 and 0.1mg/L; analysed: 0.021, 0.035 and 0.091 mg/L) exhibited symptoms directly related to the route of exposure, i.e. most effects were evident in the lungs.  The signs were indicative of local, direct effects in the lungs. PMDA is highly reactive and hydrolyses in contact with water or body fluids to the corresponding pyromellitic acid; PMDA is also a severe eye irritant. It is unsurprising that direct local effects in the lungs were observed. Other changes seen in this study were likely to be related to physiological stress because of the clinical signs induced via inhalation exposure to the dusts. Only the lungs showed any histopathological treatment related signs, importantly the signs seen were only slight to very slight. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82ba9150-eae2-4d20-8c6c-0d22df527df0/documents/9442cd01-9204-4d04-a919-7968ade06358_ee71dc18-f900-4442-b392-75c352d43a1c.html,,,,,, "Benzene-1,2:4,5-tetracarboxylic dianhydride",89-32-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82ba9150-eae2-4d20-8c6c-0d22df527df0/documents/9442cd01-9204-4d04-a919-7968ade06358_ee71dc18-f900-4442-b392-75c352d43a1c.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,91 mg/m3,,rat "Benzene-1,2:4,5-tetracarboxylic dianhydride",89-32-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82ba9150-eae2-4d20-8c6c-0d22df527df0/documents/9442cd01-9204-4d04-a919-7968ade06358_ee71dc18-f900-4442-b392-75c352d43a1c.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Benzene-1,2:4,5-tetracarboxylic dianhydride",89-32-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82ba9150-eae2-4d20-8c6c-0d22df527df0/documents/9442cd01-9204-4d04-a919-7968ade06358_ee71dc18-f900-4442-b392-75c352d43a1c.html,Repeated dose toxicity – local effects,inhalation,LOAEC,21 mg/m3,adverse effect observed,rat "Benzene-1,2:4,5-tetracarboxylic dianhydride",89-32-7," Acute oral toxicity The study was performed in accordance with OECD Guidelines for Testing of Chemicals No 420 (fixed dose method) and EU-Method B1. No treatment-related effects were noted. The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley rat was estimated to be greater than 2000 mg/kg bodyweight. The registered chemical is unstable in water. A supporting acute oral toxicity test of the hydrolysis product Pyromellitic acid PMA with identical study design resulted in a LD50 of > 2000 mg/kg. Acute dermal toxicity An acute dermal toxicity study was performed in Wistar rats, in compliance with OECD Guideline No. 402. A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as a single dermal 24-hour exposure followed by a 14-day observation period.. The test item did not cause mortality at the dose level of 2000 mg/kg bw. There were no systemic clinical signs noted in any animal throughout the study. No local dermal signs were observed after treatment with the test item during the 14 days observation period. Body weight gains of treated animals during the study showed no indication of a test item-related effect. There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw. In conclusion, the acute dermal median lethal dose (LD50 value) of the test item was found to be above 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82ba9150-eae2-4d20-8c6c-0d22df527df0/documents/3f629ee0-c20f-4391-852b-db60e5b6a3c9_ee71dc18-f900-4442-b392-75c352d43a1c.html,,,,,, "Benzene-1,2:4,5-tetracarboxylic dianhydride",89-32-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82ba9150-eae2-4d20-8c6c-0d22df527df0/documents/3f629ee0-c20f-4391-852b-db60e5b6a3c9_ee71dc18-f900-4442-b392-75c352d43a1c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzene-1,2:4,5-tetracarboxylic dianhydride",89-32-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82ba9150-eae2-4d20-8c6c-0d22df527df0/documents/3f629ee0-c20f-4391-852b-db60e5b6a3c9_ee71dc18-f900-4442-b392-75c352d43a1c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzene-1,3,5-tricarbonyl trichloride",4422-95-1, No data. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a602f3c-d3db-46ab-bb8b-66c5e5d72b74/documents/6cdb643e-70ad-4d6b-98b4-3a87b8bf8466_3ef23308-b46a-4213-b0b9-0a3102e8464c.html,,,,,, "Benzene-1,3,5-tricarbonyl trichloride",4422-95-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a602f3c-d3db-46ab-bb8b-66c5e5d72b74/documents/6cdb643e-70ad-4d6b-98b4-3a87b8bf8466_3ef23308-b46a-4213-b0b9-0a3102e8464c.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, "Benzene-1,3,5-tricarboxylic acid",554-95-0, The test substanz is of very low oral acute toxicity with an oral LD50 (rat) of > 16 g/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55d1e08a-ac6a-45da-afcc-967dc7ee5c1f/documents/f5df43c0-ee52-4c29-a54a-c8089b178c6f_a7621f47-dcb0-4063-a427-f17e99d1575f.html,,,,,, "Benzene-1,3,5-tricarboxylic acid",554-95-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55d1e08a-ac6a-45da-afcc-967dc7ee5c1f/documents/f5df43c0-ee52-4c29-a54a-c8089b178c6f_a7621f47-dcb0-4063-a427-f17e99d1575f.html,,oral,LD50,"16,000 mg/kg bw",no adverse effect observed, methyl 2-methyl-2-phenylpropanoate,57625-74-8,No reliable data are available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fd126af-d5d2-4c7f-bad4-0b8948095b9d/documents/IUC5-56ebac92-de80-499d-a64e-6548048abf2f_87d1b7db-67fa-47b3-a064-f5b47fa6e10e.html,,,,,, "Benzeneacetic acid, α-hydroxy-, monoammonium salt, (αR)-",217308-07-1,"LD50 (oral,rat): ca. 5000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0244c8b1-bcea-4985-8055-596ec94c99c2/documents/IUC5-24d4f9aa-fbee-4e4b-8886-f32af873287a_b57fe53f-14bc-4b1f-a0f0-dd677a2db6bb.html,,,,,, "Benzeneacetic acid, α-hydroxy-, monoammonium salt, (αR)-",217308-07-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0244c8b1-bcea-4985-8055-596ec94c99c2/documents/IUC5-24d4f9aa-fbee-4e4b-8886-f32af873287a_b57fe53f-14bc-4b1f-a0f0-dd677a2db6bb.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, ethyl 1-(2-mesitylacetoxy)cyclopentanecarboxylate,361366-15-6,"Acute oral toxicity, rat, OECD 423: LD > 2,500 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd056a85-a22c-4d67-86a4-3684617c9df9/documents/e2d5b1f7-bf75-4619-add0-bddc31db3279_fad7d414-7891-4438-83b4-0998999e1d30.html,,,,,, ethyl 1-(2-mesitylacetoxy)cyclopentanecarboxylate,361366-15-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd056a85-a22c-4d67-86a4-3684617c9df9/documents/e2d5b1f7-bf75-4619-add0-bddc31db3279_fad7d414-7891-4438-83b4-0998999e1d30.html,,oral,LD50,"> 2,500 mg/kg bw",no adverse effect observed, "Benzeneacetic acid, 4-[4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-1-oxobutyl]-α,α-dimethyl-",76811-98-8,The dermal LD50 is > 2000 mg/kg (male/female rat).The oral LD50 is > 5000 mg/kg (male/female rat). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31db6ba3-3c30-4032-9dc7-b8684eed6265/documents/IUC5-4c5144c5-96e0-44b3-8bc9-a2f187563c5f_667a2d7b-3975-43ae-b32e-479d96d3627f.html,,,,,, "Benzeneacetic acid, 4-[4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-1-oxobutyl]-α,α-dimethyl-",76811-98-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31db6ba3-3c30-4032-9dc7-b8684eed6265/documents/IUC5-4c5144c5-96e0-44b3-8bc9-a2f187563c5f_667a2d7b-3975-43ae-b32e-479d96d3627f.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Benzeneacetic acid, 4-[4-[4-(hydroxydiphenylmethyl)-1-piperidinyl]-1-oxobutyl]-α,α-dimethyl-",76811-98-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31db6ba3-3c30-4032-9dc7-b8684eed6265/documents/IUC5-4c5144c5-96e0-44b3-8bc9-a2f187563c5f_667a2d7b-3975-43ae-b32e-479d96d3627f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl 2-[4-[4-[4-[hydroxy(diphenyl)methyl]piperidin-1-yl]butanoyl]phenyl]-2-methylpropanoate,154477-55-1,The dermal LD50 is > 2000 mg/kg (male/female rat).The oral LD50 is > 2000 mg/kg (male/female rat). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6f61fea-b7c6-4c67-ac8c-3acbeb877c6b/documents/IUC5-cc246d00-113d-4393-ac1f-d9e17daa87d1_0d69f205-2b92-464f-b78a-f8693efebe5d.html,,,,,, Methyl 2-[4-[4-[4-[hydroxy(diphenyl)methyl]piperidin-1-yl]butanoyl]phenyl]-2-methylpropanoate,154477-55-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6f61fea-b7c6-4c67-ac8c-3acbeb877c6b/documents/IUC5-cc246d00-113d-4393-ac1f-d9e17daa87d1_0d69f205-2b92-464f-b78a-f8693efebe5d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl 2-[4-[4-[4-[hydroxy(diphenyl)methyl]piperidin-1-yl]butanoyl]phenyl]-2-methylpropanoate,154477-55-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6f61fea-b7c6-4c67-ac8c-3acbeb877c6b/documents/IUC5-cc246d00-113d-4393-ac1f-d9e17daa87d1_0d69f205-2b92-464f-b78a-f8693efebe5d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-(4-bromophenyl)-2-methylpropanoic acid,32454-35-6,No reliable data are available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0b792d5-f05f-43a0-9c9e-29d47f24172c/documents/IUC5-5ab12d19-a3fa-440c-ac5e-ee4792abcb73_e057ed0b-a51f-4c50-8581-b2f30898e07c.html,,,,,, "Benzeneacetic acid, α-ethylidene-4-nitro-",90924-63-3, Oral: The oral LD50 value of the test item in Wistar rat was established to exceed 2000 mg/kg bw. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d4074d0-ddac-46ac-bddb-06d4cca4e083/documents/217b12d0-e58c-4541-8a92-7fe384786c74_ac4dc9fc-9e82-4456-8c6b-b480f633f9d5.html,,,,,, "Benzeneacetic acid, α-ethylidene-4-nitro-",90924-63-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d4074d0-ddac-46ac-bddb-06d4cca4e083/documents/217b12d0-e58c-4541-8a92-7fe384786c74_ac4dc9fc-9e82-4456-8c6b-b480f633f9d5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzeneacetic acid, α-hydroxy-, (αS)-(γS)-compd. with N-methyl-γ-(2-methylphenoxy)benzenepropanamine (1:1)",872996-05-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): 0.33 mg/L/1h ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fabd9f7-9b1c-4863-9fe4-4a12b5b5517f/documents/89bc7400-d682-4d2c-8dcf-369f06d9d673_df67f554-fdd4-49f5-ba6d-3726bfbd3d75.html,,,,,, "Benzeneacetic acid, α-hydroxy-, (αS)-(γS)-compd. with N-methyl-γ-(2-methylphenoxy)benzenepropanamine (1:1)",872996-05-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fabd9f7-9b1c-4863-9fe4-4a12b5b5517f/documents/89bc7400-d682-4d2c-8dcf-369f06d9d673_df67f554-fdd4-49f5-ba6d-3726bfbd3d75.html,,oral,LD50,196 mg/kg bw,adverse effect observed, 2-ethoxybenzenecarboximidamide hydrochloride,18637-00-8,"Ethoxyamidin HCl is harmful after single oral exposure (LD50, rat: > 300 - < 500 mg/kg bw). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea73a389-e4f0-4962-bd12-224ab1e9f81a/documents/IUC5-a56cff53-dff5-4b04-9a95-301fad3d7677_b03a6140-22ff-49f3-adb2-2ed6fc644d38.html,,,,,, (R)-(+)-ą-4-Dimethylbenzylamine,4187-38-6," The oral LD50 of rac-1-(3-Methoxyphenyl)ethylamine (read across, CAS 62409-13-6) was between 300 and 2000 mg/kg bw (OECD 423). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c980b66f-2120-4f22-907d-482b69c15b7a/documents/IUC5-a9883245-d60e-4b18-992c-b65e350c9110_4d5836ca-4eab-441f-92bb-34d00bb7ae36.html,,,,,, (S)-1-(p-tolyl)ethanamine,27298-98-2,"The oral LD50 of rac-1-(3-Methoxyphenyl)ethylamine (read across, CAS 62409-13-6) was between 300 and 2000 mg/kg bw (OECD 423). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c19880f5-958c-4797-ac86-a3a246a5510d/documents/IUC5-f09c4875-1752-4bc3-bf77-6a42872f7459_a009e8ab-d1b3-4bf3-b40a-8e3b6a0b57e9.html,,,,,, 1-Phenylpropylamine,2941-20-0,"oralrat (OECD 407) NOEL (m/f): >15 mg/kg bw/day (highest dose tested) [SafePharm Laboratories, 2004]dermalActually, there is no information available.inhalationActually, there is no information available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd133da0-6635-44df-a532-d9e16b6bcebc/documents/IUC5-e21e0497-2ded-4922-89b3-538ebfe3adfb_aeb724d2-8a52-4907-9bac-04deb473cf8d.html,,,,,, 1-Phenylpropylamine,2941-20-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd133da0-6635-44df-a532-d9e16b6bcebc/documents/IUC5-e21e0497-2ded-4922-89b3-538ebfe3adfb_aeb724d2-8a52-4907-9bac-04deb473cf8d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,, 1-Phenylpropylamine,2941-20-0,"Acute Oral toxicityRat: LD50 200-500 mg/kg bw (OECD 423); [BASF, 1998; Calvert Preclinical Services, 2000] Acute Inhalation toxicityActually, there is no information available to cover this endpoint.Acute Dermal toxicityActually, there is no information available to cover this endpoint. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd133da0-6635-44df-a532-d9e16b6bcebc/documents/IUC5-6a856824-3ac1-49eb-8971-2edf70304516_aeb724d2-8a52-4907-9bac-04deb473cf8d.html,,,,,, (R)-1-PHENYLPROPYLAMINE,3082-64-2,"oralrat (OECD 407) NOEL (m/f): >15 mg/kg bw/day (highest dose tested) [SafePharm Laboratories, 2004]dermalActually, there is no information available.inhalationActually, there is no information available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/625199b2-9652-40f6-9dba-d7eadf951960/documents/IUC5-7d060308-c68a-4ac9-a86e-d2920878516d_a623bca6-9ee7-4872-ae8a-c0e595826842.html,,,,,, (R)-1-PHENYLPROPYLAMINE,3082-64-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/625199b2-9652-40f6-9dba-d7eadf951960/documents/IUC5-7d060308-c68a-4ac9-a86e-d2920878516d_a623bca6-9ee7-4872-ae8a-c0e595826842.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,, (R)-1-PHENYLPROPYLAMINE,3082-64-2,"Acute Oral toxicityRat: LD50 200-500 mg/kg bw (OECD 423); [BASF, 1998; Calvert Preclinical Services, 2000] Acute Inhalation toxicityActually, there is no information available to cover this endpoint.Acute Dermal toxicityActually, there is no information available to cover this endpoint. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/625199b2-9652-40f6-9dba-d7eadf951960/documents/IUC5-1f5e1b67-e3e5-4e14-8863-aaad34440655_a623bca6-9ee7-4872-ae8a-c0e595826842.html,,,,,, (1S)-1-phenylpropan-1-amine,3789-59-1,"oralrat (OECD 407) NOEL (m/f): >15 mg/kg bw/day (SafePharm Laboratories, 2004)dermalActually, there is no information available.inhalationActually, there is no information available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/71b80516-dc9f-46ba-a51c-3776b9312313/documents/IUC5-35ed45df-f3f1-4602-b9c4-38fc09f42ccb_dc0cac06-0d8e-4493-bb0d-f717befe6ed2.html,,,,,, (1S)-1-phenylpropan-1-amine,3789-59-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/71b80516-dc9f-46ba-a51c-3776b9312313/documents/IUC5-35ed45df-f3f1-4602-b9c4-38fc09f42ccb_dc0cac06-0d8e-4493-bb0d-f717befe6ed2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,, (1S)-1-phenylpropan-1-amine,3789-59-1,"Acute Oral toxicityRat: LD50 (m/f) 200 - 2000 mg/kg bw (OECD 423) [Calvert Preclinical Services, 2000; BASF, 1998] Acute Inhalation toxicityCurrently, there is no information available to cover this endpoint.Acute Dermal toxicityCurrently, there is no information available to cover this endpoint. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71b80516-dc9f-46ba-a51c-3776b9312313/documents/IUC5-6d14d178-480a-4cbd-aaa8-a72157c55920_dc0cac06-0d8e-4493-bb0d-f717befe6ed2.html,,,,,, "1-(2-chlorophenyl)-N,N-dimethylmethanamine",10175-31-2," Acute toxicity: oral The single-dose oral toxicity of the test material, dissolved in PEG 400, was performed according OECD TG 423 with female Wistar rats. The test material caused mortality at a dose level of 2000 mg/kg bw (3/3) and 300 mg/kg bw (1/6). Clinical signs were observed in animals treated at 300 mg/kg bw with the test material. These included decreased activity (3/6), hunched back (6/6), tremors (intermitten) whole body (2/6) and death (1/6). Body weight and body weight gain showed no indication of a treatment-related effect. There was no evidence of the macroscopic observations in surviving animals dosed at 300 mg/kg bw and terminated on Day 14. Under the conditions of this study, the acute oral LD50 value of the test material was found to be between 300 and 2000 mg/kg bw. Acute toxicity: dermal After a single topical administration of the undiluted test material to rats, followed by a fourteen-day observation period, mortality was observed (1/1 male and 1/1 female) on day 0 at the dose level of 2000 mg/kg bw. No mortality (0/10) was observed at the dose level of 1000 mg/kg bw. No systemic clinical signs were observed after treatment. There were no treatment related effects on body weight or body weight gain. Thus the median lethal dose of the neat test material after a single dermal administration was found to be between 1000 and 2000 mg/kg bw in male and female rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db19c783-b73d-432a-b0db-a80d5103f0c2/documents/6bca378e-db75-4759-b2fc-82a91cb1a877_8dbc67a0-aaac-49a3-a1f8-7abb30e562dc.html,,,,,, "1-(2-chlorophenyl)-N,N-dimethylmethanamine",10175-31-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db19c783-b73d-432a-b0db-a80d5103f0c2/documents/6bca378e-db75-4759-b2fc-82a91cb1a877_8dbc67a0-aaac-49a3-a1f8-7abb30e562dc.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, "1-(2-chlorophenyl)-N,N-dimethylmethanamine",10175-31-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db19c783-b73d-432a-b0db-a80d5103f0c2/documents/6bca378e-db75-4759-b2fc-82a91cb1a877_8dbc67a0-aaac-49a3-a1f8-7abb30e562dc.html,,dermal,discriminating dose,"1,000 mg/kg bw",adverse effect observed, (R)-1-(3-methoxyphenyl)ethylamine,88196-70-7,"The oral LD50 of rac-1-(3-Methoxyphenyl)ethylamine (read across, CAS 62409-13-6) was between 300 and 2000 mg/kg bw (OECD 423). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6838d041-d05e-43c5-8932-8fee1ab68600/documents/IUC5-3490d564-14c4-4bfd-98c6-2a03f833cc0a_bc4ca103-a6f1-488a-8ae0-92f30d1c04b1.html,,,,,, (S)-1-(3-methoxyphenyl)ethylamine,82796-69-8,"The oral LD50 of rac-1-(3-Methoxyphenyl)ethylamine (read across, CAS 62409-13-6) was between 300 and 2000 mg/kg bw (OECD 423). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f85698d8-db64-4223-ac22-040bd992ea73/documents/IUC5-39540e6f-8b8a-4cb7-a788-24ededa4705e_8974ee96-f91e-4b5f-b215-e027706e8394.html,,,,,, (R)-1-(4-METHOXYPHENYL)ETHYLAMINE,22038-86-4,"The oral LD50 of rac-1-(3-Methoxyphenyl)ethylamine (read across, CAS 62409-13-6) was between 300 and 2000 mg/kg bw (OECD 423). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9807ec39-a8bb-4575-a646-cfd85cc6907b/documents/IUC5-b95c05f8-1bc9-4053-9e76-184d1d05b5ea_b9e6157d-bfba-4e1c-aafe-d3f99699e8e3.html,,,,,, (S)-1-(4-Methoxyphenyl)ethylamine,41851-59-6,"The oral LD50 of rac-1-(3-Methoxyphenyl)ethylamine (read across, CAS 62409-13-6) was between 300 and 2000 mg/kg bw (OECD 423). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b4f37e3-576f-4513-b11b-300aa50862b9/documents/IUC5-cfda5b50-267c-4372-b4ab-babf55124fe6_3beea829-e6e6-4c80-aa69-f361adda825e.html,,,,,, Benzyltrimethylammonium 2-hydroxy-2-methyl-propionate,1431696-36-4,The acute oral LD50 in rat was higher than 50 mg/kg bw (no mortality) and lower than 300 mg/kg bw (100% mortality) as investigated in a GLP and OECD 423 compliant study. Mortality occurred shortly after doing. No specific target organ for acute toxicity could be identified. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86104b4f-f8cb-4dc3-aba3-3a3832ce6af8/documents/IUC5-f0ab8425-cccf-4c45-9323-0b6f29001a17_44d4c906-e447-4caa-905c-411b45102817.html,,,,,, Benzyltrimethylammonium 2-hydroxy-2-methyl-propionate,1431696-36-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86104b4f-f8cb-4dc3-aba3-3a3832ce6af8/documents/IUC5-f0ab8425-cccf-4c45-9323-0b6f29001a17_44d4c906-e447-4caa-905c-411b45102817.html,,oral,discriminating dose,50 mg/kg bw,adverse effect observed, "(S)-1-(2,6-Dichloro-3-fluorophenyl)ethanol",877397-65-4,"Acute dermal toxicity: A primary dermal toxicity study (Beerens-Heijnen, 2010) was available which is key study.This study showed that the dermal LD50 value of test substance is established to be in the range of 1000-2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e457fb7c-5f8c-446d-a567-a94459923900/documents/IUC5-efca81cd-c427-4d03-ac09-0d864a45611d_0f7ccf0b-a27c-4b1f-83df-945351cd3e72.html,,,,,, "(S)-1-(2,6-Dichloro-3-fluorophenyl)ethanol",877397-65-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e457fb7c-5f8c-446d-a567-a94459923900/documents/IUC5-efca81cd-c427-4d03-ac09-0d864a45611d_0f7ccf0b-a27c-4b1f-83df-945351cd3e72.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, (1S)-1-[3-[(1E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propanol,287930-77-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bba39856-68be-4db0-a20c-f2ba5231cc8c/documents/IUC5-3a12463f-cb8a-4c7b-8530-bc3d206cf0d6_76d1a745-6dfc-468c-8058-5144e6942479.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat (1S)-1-[3-[(1E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propanol,287930-77-2,The key studies are an acute oral toxicity study in rats and an acute dermal toxicity in rats both with an LD50 of >2000 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bba39856-68be-4db0-a20c-f2ba5231cc8c/documents/IUC5-14c40818-f3b3-4970-80e2-532846aa70c4_76d1a745-6dfc-468c-8058-5144e6942479.html,,,,,, (1S)-1-[3-[(1E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propanol,287930-77-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bba39856-68be-4db0-a20c-f2ba5231cc8c/documents/IUC5-14c40818-f3b3-4970-80e2-532846aa70c4_76d1a745-6dfc-468c-8058-5144e6942479.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, (1S)-1-[3-[(1E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propanol,287930-77-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bba39856-68be-4db0-a20c-f2ba5231cc8c/documents/IUC5-14c40818-f3b3-4970-80e2-532846aa70c4_76d1a745-6dfc-468c-8058-5144e6942479.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzenemethanol, α-[(1S)-2-(dimethylamino)-1-methylethyl]-α-ethyl-3-methoxy-, (αR)-",809282-20-0," The oral acute toxicity test with rats (OECD guideline 423) was performed.  It was noted the death of 3 treated rats at 2000 mg/kg bw, 10 minutes after the test item administration. The mortalities were preceded by convulsions, during the first minutes of the test. No mortality occurred in the animals treated with 300 mg/kg bw. The LD50 (rat, oral) = 500 mg/kg bw. GHS classification: Acute oral cat 4, H302. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/144acd4e-b5e2-4310-b715-f8f4174729da/documents/ae1c97c6-b33d-4b90-9050-dc5b74a2dbd7_a070ca4e-003f-4f82-a1ab-d4f5bff94470.html,,,,,, "Benzenemethanol, α-[(1S)-2-(dimethylamino)-1-methylethyl]-α-ethyl-3-methoxy-, (αR)-",809282-20-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/144acd4e-b5e2-4310-b715-f8f4174729da/documents/ae1c97c6-b33d-4b90-9050-dc5b74a2dbd7_a070ca4e-003f-4f82-a1ab-d4f5bff94470.html,,oral,LD50,500 mg/kg bw,adverse effect observed, 3-(4-isobutyl-2-methylphenyl)propanal,1637294-12-2,"A Repeated dose 28-day oral toxicity study with GR-88 -0778 was performed by daily gavage in the rat, followed by a 14 -day recovery period according to the OECD Guideline No.: 407. The NOAEL (No Observed Adverse Effect Level) for systemic toxicity was considered to be 150 mg/kg bw/day in males and females on the morphological changes in the liver of males and females and in the kidney of males.   Additionally, a 14d oral toxicity study with the registered substance had already been performed by daily gavage in the rat to specifically investigate the effects of the test item on the male reproductive organs and spermatogenesis in rats. No effects on any of the parameters monitored were observed up to the highest dose tested. As such, the NOAEL was found to exceed or equal 160 mg/kg bw/day in the rat. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9b58599-ff50-415b-abde-22433fd0dd5c/documents/18d006e5-7189-4fd0-8336-252bc3a50567_b66dbe74-5812-44ad-b7f4-d23a5426d608.html,,,,,, 3-(4-isobutyl-2-methylphenyl)propanal,1637294-12-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9b58599-ff50-415b-abde-22433fd0dd5c/documents/18d006e5-7189-4fd0-8336-252bc3a50567_b66dbe74-5812-44ad-b7f4-d23a5426d608.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat 3-(4-isobutyl-2-methylphenyl)propanal,1637294-12-2,"Acute Oral Toxicity The acute oral toxicity with NYMPHEAL was assessed in the rat (Fixed Dose Method) according to the OECD No.420 (2001) "" Acute toxicity-oral, Fixed Dose Procedure"". LD50 oral > 2000mg/kg bw. Acute Dermal Toxicity: The acute dermal toxicity with NYMPHEAL in the rat was assessed according the OECD No.402 (1987) ""Acute Dermal Toxicity"". LD50 dermal > 2000mg/kg bw. Acute Inhalation Toxicity: The acute inhalation toxicity with NYMPHEAL in the rat was assessed according the OECD No.403 (2009) ""Acute Inhalation Toxicity"". LC50, 4h in the range of 1 -5 mg/L, based only on animal sacrificed on D2 due to clinical observations and where at necropsy only 1/5 Male and 1/5 Female at dose 5mg/L were found with actual macroscopic findings in the lung (several red foci). Moreover, all surviving animals in the lower doses saw their clinical signs recover by D3. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9b58599-ff50-415b-abde-22433fd0dd5c/documents/01032ceb-3bb6-42ce-b9df-46e9389ec297_b66dbe74-5812-44ad-b7f4-d23a5426d608.html,,,,,, 3-(4-isobutyl-2-methylphenyl)propanal,1637294-12-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9b58599-ff50-415b-abde-22433fd0dd5c/documents/01032ceb-3bb6-42ce-b9df-46e9389ec297_b66dbe74-5812-44ad-b7f4-d23a5426d608.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 3-(4-isobutyl-2-methylphenyl)propanal,1637294-12-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9b58599-ff50-415b-abde-22433fd0dd5c/documents/01032ceb-3bb6-42ce-b9df-46e9389ec297_b66dbe74-5812-44ad-b7f4-d23a5426d608.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 3-(4-isobutyl-2-methylphenyl)propanal,1637294-12-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9b58599-ff50-415b-abde-22433fd0dd5c/documents/01032ceb-3bb6-42ce-b9df-46e9389ec297_b66dbe74-5812-44ad-b7f4-d23a5426d608.html,,inhalation,LC50,"1,000 mg/m3",adverse effect observed, "3-(2-methoxy-5-methylphenyl)-3-phenyl-N,N-di(propan-2-yl)propan-1-aminium bromide",857288-56-3,Key study: Acute oral toxicity study: OECD guideline 420 and EU method B.1 bis. GLP study.The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg bodyweight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4efa798e-4a2e-41c6-b70e-9ce8db501ab7/documents/IUC5-8cea4ab6-7406-4f62-8751-1d49547923c0_640075c7-ff68-411a-8f57-ab4001d2b91c.html,,,,,, "3-(2-methoxy-5-methylphenyl)-3-phenyl-N,N-di(propan-2-yl)propan-1-aminium bromide",857288-56-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4efa798e-4a2e-41c6-b70e-9ce8db501ab7/documents/IUC5-8cea4ab6-7406-4f62-8751-1d49547923c0_640075c7-ff68-411a-8f57-ab4001d2b91c.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "N-[2-(3,4-dimethoxyphenyl)ethyl]-4-(4-methoxyphenyl)butan-2-amine",61413-44-3,LD50 (oral rat): 234 mg/Kg Data on the substance Trimethoxydobutamine hydrobromide. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3db37ea8-ac7f-4ed2-9fa4-bf976ec5fbc5/documents/eb082094-edbd-42d8-893e-9043f2a2afba_7cbea529-0123-4e63-a2fc-1111a8868f19.html,,,,,, "Benzenepropanoic acid, 3,5-bis(1,1-dimethylethyl)-4-hydroxy-, 2-ethylhexyl ester",144429-84-5," The structural analogue substance induces liver metabolism which results in activation of the liver-thyroid axis in rats and effects on liver at fairly low doses (NOAEL = 5 mg/kg bw for subacute oral toxicity) (RCC, 1991). Mice are less sensitive and showed adaptive effects on liver with a NOAEL of 150 mg/kg bw for exposure for 12 - 18 weeks (Huntington, 2001). ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c46dd01f-ebff-48a9-b24d-a11de134e82e/documents/2acd9570-9076-48df-83d3-6e5619abae42_2e93edc2-61ed-4db3-a5e3-49ea5fa3b809.html,,,,,, "Benzenepropanoic acid, 3,5-bis(1,1-dimethylethyl)-4-hydroxy-, 2-ethylhexyl ester",144429-84-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c46dd01f-ebff-48a9-b24d-a11de134e82e/documents/2acd9570-9076-48df-83d3-6e5619abae42_2e93edc2-61ed-4db3-a5e3-49ea5fa3b809.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat "Benzenepropanoic acid, 3,5-bis(1,1-dimethylethyl)-4-hydroxy-, 2-ethylhexyl ester",144429-84-5, The test article caused no mortality in rats upon single oral or dermal exposure to 2000 mg/kg bw. The same is true for the structurally related analogue. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c46dd01f-ebff-48a9-b24d-a11de134e82e/documents/bed9f4bf-43d2-421b-ae51-642122bddf33_2e93edc2-61ed-4db3-a5e3-49ea5fa3b809.html,,,,,, "Benzenepropanoic acid, 3,5-bis(1,1-dimethylethyl)-4-hydroxy-, 2-ethylhexyl ester",144429-84-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c46dd01f-ebff-48a9-b24d-a11de134e82e/documents/bed9f4bf-43d2-421b-ae51-642122bddf33_2e93edc2-61ed-4db3-a5e3-49ea5fa3b809.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Benzenepropanoic acid, 3,5-bis(1,1-dimethylethyl)-4-hydroxy-, 2-ethylhexyl ester",144429-84-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c46dd01f-ebff-48a9-b24d-a11de134e82e/documents/bed9f4bf-43d2-421b-ae51-642122bddf33_2e93edc2-61ed-4db3-a5e3-49ea5fa3b809.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "C13-(branched)-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate",847488-62-4,"Subacute (28-day) study oral (gavage), rat (Sprague-Dawley) m/f: NOAEL = 1000 mg/kg bw/day (nominal) [EU Method B.7, GLP; test item: structural analogue with EC 413-750-2] ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e07936f-1e5e-44f7-af0d-81695aa07b0b/documents/IUC5-0e363eb4-5b91-4be8-a475-5453d5e7ec26_24f03d3f-8360-4643-82a0-2a0ad556a7e3.html,,,,,, "C13-(branched)-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate",847488-62-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e07936f-1e5e-44f7-af0d-81695aa07b0b/documents/IUC5-0e363eb4-5b91-4be8-a475-5453d5e7ec26_24f03d3f-8360-4643-82a0-2a0ad556a7e3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "C13-(branched)-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propanoate",847488-62-4,"Acute oral toxicity:rat (Sprague-Dawley) m/f; LD50 > 5000 mg/kg bw [EU Method B.1, GLP; test item: structural analogue with EC 413-750-2]Acute inhalation toxicity:- rat (Sprague-Dawley) m/f; LC50 > 7.5 mg/L air (4h) [OECD TG 403, GLP; test item: structural analogue with EC 413-750-2]Acute dermal toxicity:rat (Sprague-Dawley) m/f; LD50 > 2000 mg/kg bw (24h) [EU Method B.3; test item: structural analogue with EC 413-750-2] ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e07936f-1e5e-44f7-af0d-81695aa07b0b/documents/IUC5-d0dd599d-b56c-4dbb-a841-ef51573a1354_24f03d3f-8360-4643-82a0-2a0ad556a7e3.html,,,,,, "Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine",97808-67-8," Acute oral toxicity: Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS no.: 97808-67-8). The studies are as mentioned below: 1. The acute oral toxicity study was conducted by using test chemical in groups of 5 male and 5 female Fischer 344 rats at the dose concentration range from 2150 to 10,000 mg/kg bw. The given test chemical was dissolved in corn oil and administered via oral gavage route. Five dose levels of test chemical were included in each study. LD50 values were determined by probit analysis (Finney, 1964) and were based on deaths occurring within 14 days after administration. 50% mortality observed at 3161 mg/kg bw in male rats and 3828 mg/kg bw in female rats. Therefore, LD50 was considered to be 3161 mg/kg bw, with 95% confidence limit of 1344-4722 mg/kg bw in male rats and 3828 mg/kg bw, with 95% confidence limit of 2787-5255 mg/kg bw in female rats, when groups of 5 male and 5 female Fischer 344 rats were treated with test chemical via oral gavage route. 2.The acute oral toxicity study was designed and conducted to determine the acute oral toxicity profile of test chemical in Sprague Dawley rats. Initially, 3 female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. As no mortality were observed at 24 hours after the dosing, additional 3 female animals were treated with the higher dose of  2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg did not result in any signs of toxicity and mortality after the dosing. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups. The acute oral LD50 of test chemical was >2000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of test chemical, when administered via oral route in Sprague Dawley rats falls into the “Category Not classified” criteria of CLP. Thus, based on the above summarised studies, Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS no.: 97808-67-8) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine (CAS no.: 97808-67-8) cannot be classified for acute oral toxicity. Hence, based on the data available for the structurally similar read across chemical, Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine is not likely to be toxic in the dose range of >2000 - 3828 mg/Kg bw, for acute oral toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/850b7a18-9b42-4fa4-9bf9-a7b3061232e2/documents/8c1303fb-88e3-40b9-a373-d103c344d654_9c64d79d-1028-41b3-91b6-07d7059ef43c.html,,,,,, "Benzenesulfonamide, 4-methyl-, reaction products with formaldehyde and melamine",97808-67-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/850b7a18-9b42-4fa4-9bf9-a7b3061232e2/documents/8c1303fb-88e3-40b9-a373-d103c344d654_9c64d79d-1028-41b3-91b6-07d7059ef43c.html,,oral,LD50,"3,828 mg/kg bw",no adverse effect observed, N-(4-Hydroxyphenyl)benzenesulfonamide,5471-90-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A valid OECD 422 study was available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca8f150d-4c8b-4faf-9a9c-a14cbf2c633a/documents/4482b550-586e-4edb-9469-7ab80631dc72_ead32607-e3c5-4065-9342-27754dddb52e.html,,,,,, N-(4-Hydroxyphenyl)benzenesulfonamide,5471-90-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca8f150d-4c8b-4faf-9a9c-a14cbf2c633a/documents/4482b550-586e-4edb-9469-7ab80631dc72_ead32607-e3c5-4065-9342-27754dddb52e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat N-(4-Hydroxyphenyl)benzenesulfonamide,5471-90-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca8f150d-4c8b-4faf-9a9c-a14cbf2c633a/documents/IUC5-fb6d3904-8a2e-4a3e-a20d-2f51cccb60e5_ead32607-e3c5-4065-9342-27754dddb52e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, N-(4-Hydroxyphenyl)benzenesulfonamide,5471-90-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca8f150d-4c8b-4faf-9a9c-a14cbf2c633a/documents/IUC5-fb6d3904-8a2e-4a3e-a20d-2f51cccb60e5_ead32607-e3c5-4065-9342-27754dddb52e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, N-{2-[(phenylcarbamoyl)amino]phenyl}benzenesulfonamide,215917-77-4,"The NOAEL for repeat dose toxicity from a study according to OECD 408 conducted by the oral route was considered to be 1000 mg/kg bw/day in both sexes.The substance did not cause adverse effects in male or female Han: WIST rats after consecutive 90/91-day oral (by gavage) administration at 100, 300 or 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22eedb1c-67df-4ac3-a0aa-e8eddaa59526/documents/988675cc-de50-4e10-981f-62d5d070a4eb_40bc30bc-8af2-435c-8da3-78bd90668458.html,,,,,, N-{2-[(phenylcarbamoyl)amino]phenyl}benzenesulfonamide,215917-77-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22eedb1c-67df-4ac3-a0aa-e8eddaa59526/documents/988675cc-de50-4e10-981f-62d5d070a4eb_40bc30bc-8af2-435c-8da3-78bd90668458.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat N-{2-[(phenylcarbamoyl)amino]phenyl}benzenesulfonamide,215917-77-4,"Acute oral and inhalation toxicity tests were conducted as these were considered the most likely routes of exposure. The oral LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/ kg body weight. The inhalation LC50 value of the test substance in Wistar rats was established to exceed 5.23 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22eedb1c-67df-4ac3-a0aa-e8eddaa59526/documents/e6e553cb-9844-4f79-8f39-3fc6d41dad2c_40bc30bc-8af2-435c-8da3-78bd90668458.html,,,,,, N-{2-[(phenylcarbamoyl)amino]phenyl}benzenesulfonamide,215917-77-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22eedb1c-67df-4ac3-a0aa-e8eddaa59526/documents/e6e553cb-9844-4f79-8f39-3fc6d41dad2c_40bc30bc-8af2-435c-8da3-78bd90668458.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, N-{2-[(phenylcarbamoyl)amino]phenyl}benzenesulfonamide,215917-77-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22eedb1c-67df-4ac3-a0aa-e8eddaa59526/documents/e6e553cb-9844-4f79-8f39-3fc6d41dad2c_40bc30bc-8af2-435c-8da3-78bd90668458.html,,inhalation,LC50,"5,230 mg/m3",no adverse effect observed, 2-acetamido-5-chlorobenzenesulfonic acid;pyridine,54981-42-9,No study are available on the substance. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6c584a5-62cc-42df-aad6-212aeabeaf34/documents/IUC5-8ce97e4b-0476-4943-9b71-5a591b3e3eca_53be1446-6c19-4ab7-bcf7-b7c95d491db1.html,,,,,, "tetrasodium 2,2'-ethene-1,2-diylbis[5-({4-[diethylamino]-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]",42355-78-2, NOAEL in male rats ≥ 250 mg/kg bw/day (based on the sub-acute study on OB 3b-A) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92bf234d-2e9f-4302-a0aa-efc1b075c59e/documents/42959400-8bf1-4c2a-9282-bc67f32f68be_5b277b6a-87c6-486a-b1ad-c05579cfe51c.html,,,,,, "tetrasodium 2,2'-ethene-1,2-diylbis[5-({4-[diethylamino]-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]",42355-78-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92bf234d-2e9f-4302-a0aa-efc1b075c59e/documents/42959400-8bf1-4c2a-9282-bc67f32f68be_5b277b6a-87c6-486a-b1ad-c05579cfe51c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "tetrasodium 2,2'-ethene-1,2-diylbis[5-({4-[diethylamino]-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]",42355-78-2, Rat oral LD50 > 2000 mg/kg bw Rat inhalation LC50 > 1895 mg/m3 Rat dermal LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92bf234d-2e9f-4302-a0aa-efc1b075c59e/documents/IUC5-057ccaf8-2ab0-48ca-aaa5-040f19c89f06_5b277b6a-87c6-486a-b1ad-c05579cfe51c.html,,,,,, "tetrasodium 2,2'-ethene-1,2-diylbis[5-({4-[diethylamino]-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]",42355-78-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92bf234d-2e9f-4302-a0aa-efc1b075c59e/documents/IUC5-057ccaf8-2ab0-48ca-aaa5-040f19c89f06_5b277b6a-87c6-486a-b1ad-c05579cfe51c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "tetrasodium 2,2'-ethene-1,2-diylbis[5-({4-[diethylamino]-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]",42355-78-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92bf234d-2e9f-4302-a0aa-efc1b075c59e/documents/IUC5-057ccaf8-2ab0-48ca-aaa5-040f19c89f06_5b277b6a-87c6-486a-b1ad-c05579cfe51c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "tetrasodium 2,2'-ethene-1,2-diylbis[5-({4-[diethylamino]-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]",42355-78-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92bf234d-2e9f-4302-a0aa-efc1b075c59e/documents/IUC5-057ccaf8-2ab0-48ca-aaa5-040f19c89f06_5b277b6a-87c6-486a-b1ad-c05579cfe51c.html,,inhalation,,"1,895 mg/m3",no adverse effect observed, "Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-amino-1-naphthalenyl)azo]benzenesulfonic acid monosodium salt",1325-65-1,"5 rat/sex were dosed by oral route at 5000 mg/kg as single dose. Observations were carried out for 14 days after dosing. Under the reported experimental conditions the LD50 resulted > 5000 mg/kg.   RA similar substance 01 - Upon an acute oral administration and a 14 day post-treatment observation period in rats of both sexes, no mortality was recorded. Therefore, in male and female rats:LD0 = 2000 mg/kgLD50 > 2000 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3990e3c-2a4a-476c-9aa3-7c2b7e70b293/documents/de557bcc-590e-4240-9006-a0e331b0088a_cc8ef804-da06-47b1-a4ce-260b743ecff4.html,,,,,, "Benzenesulfonic acid, 2,2'-(1,2-ethenediyl)bis[5-nitro-, disodium salt, reaction products with 4-[(4-amino-1-naphthalenyl)azo]benzenesulfonic acid monosodium salt",1325-65-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3990e3c-2a4a-476c-9aa3-7c2b7e70b293/documents/de557bcc-590e-4240-9006-a0e331b0088a_cc8ef804-da06-47b1-a4ce-260b743ecff4.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "4-Ethoxy-3-(5-methyl-4-oxo-7-propyl-3,4-dihydroimidazo[5,1-f][1,2,4]triazin-2-yl) benzenesulfonic acid",437717-43-6,"Sulfotriazinonsäure is non toxic after single oral exposure (LD50 cut-off, rat: > 2500 mg/kg bw). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b99eda6-cbad-483f-ae61-77000f4ac6eb/documents/IUC5-26b7125e-4dd0-4b5f-9982-9e90f4f6c896_c6c01b07-6cc4-4e9c-a2fc-e1e47cf1604c.html,,,,,, "4-Ethoxy-3-(5-methyl-4-oxo-7-propyl-3,4-dihydroimidazo[5,1-f][1,2,4]triazin-2-yl) benzenesulfonic acid",437717-43-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b99eda6-cbad-483f-ae61-77000f4ac6eb/documents/IUC5-26b7125e-4dd0-4b5f-9982-9e90f4f6c896_c6c01b07-6cc4-4e9c-a2fc-e1e47cf1604c.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Ammonium 4-isopropylbenzenesulphonate,680972-33-2," The study with the lowest NOAEL for local effects (hyperplasia of the epidermis) is the 2 year dermal carcinogenicity study in the rat, where the NOAEL for females was 60 mg/kg. Taking a mean body weight figure for the female rats in the 60 mg/kg dose group of 0.2kg (stated range = 0.107 to 0.288 kg) and assuming a surface area of dosing of 25 cm2, gives a NOAEL of 0.48 mg/cm2.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78161ecc-361a-44f6-b156-eec306646beb/documents/a608787d-f018-4153-97a5-49d126eba770_cdea9021-36c3-40b6-86df-1bba44543141.html,,,,,, Ammonium 4-isopropylbenzenesulphonate,680972-33-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78161ecc-361a-44f6-b156-eec306646beb/documents/a608787d-f018-4153-97a5-49d126eba770_cdea9021-36c3-40b6-86df-1bba44543141.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,763 mg/kg bw/day,,rat Ammonium 4-isopropylbenzenesulphonate,680972-33-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78161ecc-361a-44f6-b156-eec306646beb/documents/a608787d-f018-4153-97a5-49d126eba770_cdea9021-36c3-40b6-86df-1bba44543141.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.48 mg/cm2,adverse effect observed,rat Ammonium 4-isopropylbenzenesulphonate,680972-33-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78161ecc-361a-44f6-b156-eec306646beb/documents/70bc227e-f71f-46e6-946f-48cdf54c3c61_cdea9021-36c3-40b6-86df-1bba44543141.html,,oral,LD50,"3,346 mg/kg bw",adverse effect observed, Ammonium 4-isopropylbenzenesulphonate,680972-33-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78161ecc-361a-44f6-b156-eec306646beb/documents/70bc227e-f71f-46e6-946f-48cdf54c3c61_cdea9021-36c3-40b6-86df-1bba44543141.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ammonium 4-isopropylbenzenesulphonate,680972-33-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78161ecc-361a-44f6-b156-eec306646beb/documents/70bc227e-f71f-46e6-946f-48cdf54c3c61_cdea9021-36c3-40b6-86df-1bba44543141.html,,inhalation,LC50,"6,410 mg/m3",no adverse effect observed, potassium 4-isopropylbenzenesulphonate,164524-02-1,"The HYDROTOPES Category comprises the following 6 substances: STS - Sodium toluene 4-sulphonate (CAS 657-84-1, EC 211-522-5)SXS - Sodium (xylenes and 4-ethylbenzene) sulfonates (EC 701-037-1)NH4XS - Ammonium (xylenes and 4-ethylbenzene) sulfonates (EC 943-024-5)SCS - Sodium p-cumenesulphonate (CAS 15763-76-5, EC 239-854-6)KCS - Potassium p-cumenesulphonate (CAS 164524-02-1, EC 629-764-9)NH4CS - Ammonium p-cumenesulphonate (CAS 680972-33-2, EC 811-484-5)  In addition CaXS (Calcium Xylenesulphonate, CAS 28088-63-3, EC 248-829-9) was evaluated for complete the assessment despite it is not registered under REACH. There are many oral repeated dose toxicity studies on the three subgroups of hydrotrope category (toluene, xylene and cumene). Most of these studies were conducted on Sodium (xylenes and 4-ethylbenzene) sulphonate however there are reliable subacute studies on Sodium toluene 4-sulphonate and a sub-chronic study on Sodium p-cumene sulphonate. The key oral study is the 90 day sub-chronic study, conducted in 1968 on Sodium (xylenes and 4-ethylbenzene) sulphonate, which is generally comparable to the OECD 408 guideline study. In that study, the highest dose for female rats - 4092 mg active ingredient (a.i.) per kilogram body weight - resulted in a loss in relative weight of the spleen. The 2nd highest dose for females - 763 mg a.i. per kilogram body weight - had no measureable adverse effects and therefore establishes the repeat dose oral NOAEL for the substance. The highest oral dose for male rats - 3534 mg a.i. per kilogram body weight - had no measurable adverse effects. No adverse effects were reported in the other available 90 day sub-chronic study on rat and mouse. There is also a 28 days oral exposure study on sodium toluene 4-sulphonate which does not show any effect with a NOAEL of 1000 mg/kg bw (highest dose tested).   The key dermal studies are the two sub-chronic studies in rat and mouse performed as part of chronic carcinogenicity study (2 -years) performed on Sodium (xylenes and 4-ethylbenzene) sulfonates. No animals died in these studies, minimal hyperplasia of the epidermis at the site of application occurred in male and female rats from the control groups as well as most dosed groups. The incidence of epidermal hyperplasia in 400 mg/mL males was considered to be possibly chemical-related. For mice, hyperplasia of the epidermis at the site of application occurred in male and female mice from the highest dose tested group. The incidence of epidermal hyperplasia in 400 mg/mL in males and females was considered to be chemical-related. In the 14 weeks exposure study, the NOAEL for rats is 500 mg a.i./kg/day based on epidermal hyperplasia and the NOAEL for mice is 440 mg/kg bw. The NOAEL for local dermal effects was set considering also the two years carcinogenicity study on dermal application which was generally comparable to the OECD 453 guideline study. There were no treatment related incidences of mononuclear cell leukaemia, neoplasms, or non-neoplastic lesions of the skin and other organs. In that study the NOAEL for females is 60 mg a.i./kg/day based on epidermal hyperplasia. This value was then used for the NOAEL for local dermal effects. No systemic toxicity was observed in this or any of the other repeat dose dermal studies. The repeated dose toxicity for inhalation exposure does not to be investigated because exposure of humans via inhalation in production and/or use is not likely as based on the thorough and rigorous exposure assessment. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): Sufficient to meet requirements. The study with the lowest NOAEL for local effects (hyperplasia of the epidermis) is the 2 year dermal carcinogenicity study in the rat, where the NOAEL for females was 60 mg/kg. Taking a mean body weight figure for the female rats in the 60 mg/kg dose group of 0.2kg (stated range = 0.107 to 0.288 kg) and assuming a surface area of dosing of 25 cm2, gives a NOAEL of 0.48 mg/cm2. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Sufficient to meet requirements ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/944f3f0e-1b20-48ab-9880-7e74599bf30e/documents/3932e1a9-5848-4de0-841b-bb68569b644b_b74b56fc-030a-437d-8b50-42f960950832.html,,,,,, potassium 4-isopropylbenzenesulphonate,164524-02-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/944f3f0e-1b20-48ab-9880-7e74599bf30e/documents/3932e1a9-5848-4de0-841b-bb68569b644b_b74b56fc-030a-437d-8b50-42f960950832.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,763 mg/kg bw/day,,rat potassium 4-isopropylbenzenesulphonate,164524-02-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/944f3f0e-1b20-48ab-9880-7e74599bf30e/documents/3932e1a9-5848-4de0-841b-bb68569b644b_b74b56fc-030a-437d-8b50-42f960950832.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.48 mg/cm2,adverse effect observed,rat potassium 4-isopropylbenzenesulphonate,164524-02-1,"The HYDROTOPES Category comprises the following 6 substances: STS - Sodium toluene 4-sulphonate (CAS 657-84-1, EC 211-522-5)SXS - Sodium (xylenes and 4-ethylbenzene) sulfonates (EC 701-037-1)NH4XS - Ammonium (xylenes and 4-ethylbenzene) sulfonates (EC 943-024-5)SCS - Sodium p-cumenesulphonate (CAS 15763-76-5, EC 239-854-6)KCS - Potassium p-cumenesulphonate (CAS 164524-02-1, EC 629-764-9)NH4CS - Ammonium p-cumenesulphonate (CAS 680972-33-2, EC 811-484-5)  In addition CaXS (Calcium Xylenesulphonate, CAS 28088-63-3, EC 248-829-9) was evaluated for complete the assessment despite it is not registered under REACH. The acute oral toxicity has been tested at least for each member of the hydrotropes subgroup (toluene, xylene and cumene). The LC50 values in rats ranging from 3000 to 16000 mg/Kg bw, depending on the tested dose. No deaths related to the test item occurred up to the highest tested doses for each available test. There is only one test for acute inhalation toxicity for NH4XS which did not show clinical effects following inhalation exposure. The acute dermal toxicity is available for xylene and cumene sulphonates with a LD50 values greater than 2000 mg/kg bw. The available data on the substances in the category show that they are all negative regarding acute toxicity. Across the hydrotropes category, toxicity results are consistent across the toluene, xylene and cumene sulfonates and their various salts. All results consistently indicate no evidence for oral, dermal and inhalation toxicity for Hydrotopes category members. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Sufficient to meet requirements, similar to OECD 401 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Sufficient to meet requirements Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Sufficient to meet requirements ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/944f3f0e-1b20-48ab-9880-7e74599bf30e/documents/a7d7758a-41b5-4eb0-9e71-101f83b5a5df_b74b56fc-030a-437d-8b50-42f960950832.html,,,,,, potassium 4-isopropylbenzenesulphonate,164524-02-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/944f3f0e-1b20-48ab-9880-7e74599bf30e/documents/a7d7758a-41b5-4eb0-9e71-101f83b5a5df_b74b56fc-030a-437d-8b50-42f960950832.html,,oral,LD50,"3,346 mg/kg bw",adverse effect observed, potassium 4-isopropylbenzenesulphonate,164524-02-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/944f3f0e-1b20-48ab-9880-7e74599bf30e/documents/a7d7758a-41b5-4eb0-9e71-101f83b5a5df_b74b56fc-030a-437d-8b50-42f960950832.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, potassium 4-isopropylbenzenesulphonate,164524-02-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/944f3f0e-1b20-48ab-9880-7e74599bf30e/documents/a7d7758a-41b5-4eb0-9e71-101f83b5a5df_b74b56fc-030a-437d-8b50-42f960950832.html,,inhalation,LC50,"6,410 mg/m3",no adverse effect observed, "Benzenesulfonic acid, 4-amino-, diazotized, coupled with diazotized 4-nitrobenzenamine and resorcinol",90218-17-0," LD50 (oral, rat) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b40b5f08-ff6f-4e49-85f5-a8d9d5146352/documents/89937209-0cf8-4b90-831a-f34742ca2d4a_21c52ac9-4d7b-449f-aa2b-cd159daa3651.html,,,,,, "Benzenesulfonic acid, 4-amino-, diazotized, coupled with diazotized 4-nitrobenzenamine and resorcinol",90218-17-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b40b5f08-ff6f-4e49-85f5-a8d9d5146352/documents/89937209-0cf8-4b90-831a-f34742ca2d4a_21c52ac9-4d7b-449f-aa2b-cd159daa3651.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, 4-amino-, diazotized, coupled with resorcinol, reaction products with formaldehyde",85828-72-4, LD50 > 2000 mg/kg body weight ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f97c8d71-ccc4-406f-acff-88838d3367b9/documents/72a7f5e1-151f-4f17-a691-93274954fdf9_e0991c42-59b8-4aba-a550-3b1b08875804.html,,,,,, "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine",84961-74-0," No repeated dose toxicity data are available for the substance LAS IPA. The endpoint was addressed with information from LAS Na and IPA. There are three studies with LAS Na: the lowest LOAEL is from the 6-month rat study (Yoneyama et al., 1972) with a LOAEL of 115 mg/kg bw.  The highest NOAEL below this LOAEL is from the 9-month rat study (Yoneyama et al., 1976) with NOAEL = 85 mg/kg bw, based on histological changes seen in the kidney. Based on the data from all the studies, an overall NOAEL of 85 mg/kg bw was considered as the most releveant, derived from a 9- month oral study and corresponding to the NOAEL closest to the lowest oral LOAEL of 115 mg/kg bw. Oral data are not available for IPA; a 90-day toxicity study available is via inhalation. Histological treatment related adverse effect observed was a local effect on the nose, that is expected to be caused by isopropylamine (free amine) and not to the ammonium cation. Other effects seen were decreased body weights and decreased serum glucose in high level female animals, as well as increases in the adrenal weights. The NOAEC of the study for the systemic effects of IPA is set at 100 mg/m3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/411fb073-b16b-40a3-8d1a-90355475f5db/documents/IUC5-498d6da1-fa8b-4235-bdde-2cd4533edb01_cccf52ef-1812-4c72-9e44-9d9814a2517b.html,,,,,, "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine",84961-74-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/411fb073-b16b-40a3-8d1a-90355475f5db/documents/IUC5-498d6da1-fa8b-4235-bdde-2cd4533edb01_cccf52ef-1812-4c72-9e44-9d9814a2517b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,85 mg/kg bw/day,,rat "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine",84961-74-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/411fb073-b16b-40a3-8d1a-90355475f5db/documents/IUC5-498d6da1-fa8b-4235-bdde-2cd4533edb01_cccf52ef-1812-4c72-9e44-9d9814a2517b.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,100 mg/m3,,rat "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine",84961-74-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/411fb073-b16b-40a3-8d1a-90355475f5db/documents/IUC5-498d6da1-fa8b-4235-bdde-2cd4533edb01_cccf52ef-1812-4c72-9e44-9d9814a2517b.html,Repeated dose toxicity – local effects,inhalation,NOAEC,100 mg/m3,adverse effect observed,rat "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine",84961-74-0," Oral toxicity: In an acute oral toxicity study (fixed dose) fasted young adult female Wistar rats (one per dose) were given a single oral dose of  benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.-, compd. with 2-propanamine (97%) at doses of 300 or 2000  mg/kg bw. No effects on the animals were seen at both dose levels, and therefore, the main study was performed with the higher dose of 2000 mg/kg bw. No adverse effects were seen and the oral LD50 is likely to be higher than 2000 mg/kg bw. Dermal toxicity: No studies on the toxic potential of the LAS-IPA itself after acute dermal exposure to this target substance were available. Therefore, the acute toxic effects of LAS-IPA on the skin were evaluated employing a read-across approach with IPA (2-propanamine) and LAS-Na (sodium 4-undecylbenzenesulfornate). Acute dermal toxicity assay (according to OECD TG 402) with IPA resulted in an LD50 greater than 400 mg/kg bw. No further doses were tested. With lack of further information, it was not possible to use this study for classification. The clipped skin on the backs of five male and five female rats were exposed to 2000 mg/kg LAS Na (limit dose) under an occlusive dressing for 24 hours and observed for another 14 days (according to OECD TG 402). Results indicate slight erythema and slight oedema but no acute mortality. The dermal LD50 is > 2000 mg/kg. Based on these results, it can be inferred that LAS IPA is not acutely toxic after oral or dermal administration. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/411fb073-b16b-40a3-8d1a-90355475f5db/documents/IUC5-fae562ac-eaa9-4cc0-ba46-799b96e393f8_cccf52ef-1812-4c72-9e44-9d9814a2517b.html,,,,,, "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine",84961-74-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/411fb073-b16b-40a3-8d1a-90355475f5db/documents/IUC5-fae562ac-eaa9-4cc0-ba46-799b96e393f8_cccf52ef-1812-4c72-9e44-9d9814a2517b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with 2-propanamine",84961-74-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/411fb073-b16b-40a3-8d1a-90355475f5db/documents/IUC5-fae562ac-eaa9-4cc0-ba46-799b96e393f8_cccf52ef-1812-4c72-9e44-9d9814a2517b.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with ethanolamine",1962138-75-5," Repeated dose toxicity studies were conducted through oral route in rats, dogs and monkeys, through dermal route in rats and through subcutaneous route in monkeys. These studies were conducted with the dissociation products MEA and LAS as well as with the read-across substance C10-14LAS. Considering the entire dataset, the highest NOAEL for systemic toxicity below the lowest LOAEL (115 mg/kg bw/day from the 26 weeks dietary study with C10-14 LAS in rats, Yoneyama, 1972, based on histopathological changes in liver and kidney) is 85 mg/kw bw/day from the 9 months drinking water study in rats with C10-14LAS (Yoneyama, 1976). In this drinking water study, the LOAEL was slightly higher at 145 mg/kg bw/day and based on liver and kidney enzyme changes. The consistency in the adverse effects seen in liver and kidneys in these studies (i.e. Yoneyama, 1976 and Yoneyama, 1972) supports the selection of 85 mg/kg bw/day as the appropriate NOAEL. Further, the selection of 85 mg/kg bw/day as the appropriate NOAEL is also supported by the higher NOAEL of 150 mg/kg bw/day observed in the 26 weeks oral gavage study in rats with C10 -13LAS (Ito, 1978b). Therefore, based on the entire data set, the point of departure taken forward for risk assessment purposes is the NOAEL of 85 mg/kg bw/day. The registered substance is an MEA-LAS salt in a 1:1 molar ratio. Based on the molecular weight this corresponds to an MEA percent weight of 16% (w/w). The relevant NOAEL of LAS for risk assessment is 85 mg/kg bw/day while the repeat dose toxicity NOAEL for MEA is higher (300 mg/kg bw/day). In other words, the effects in an MEA-LAS repeat dose study are expected to be driven first by LAS, and at higher level also by MEA. At dose levels of 85 -100 mg/kg bw/day MEA-LAS (i.e., in the range of the NOAEL for LAS), the amount dosed of MEA would be 13.6 -16 mg/kg bw/day, which is well below the anticipated NOAEL for MEA (300 mg/kg bw/day). A repeat dose toxicity study on MEA-LAS is expected to deliver doses of MEA around one order of magnitude lower than those needed to observe MEA-effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e928c2a-d3e2-4e20-ac47-97e3229894b3/documents/88bdc4e0-7b15-4ea0-a5ef-df8abc9b5bcd_ac10d2a9-cb65-42ce-bd86-1274c3e5f705.html,,,,,, "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with ethanolamine",1962138-75-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e928c2a-d3e2-4e20-ac47-97e3229894b3/documents/88bdc4e0-7b15-4ea0-a5ef-df8abc9b5bcd_ac10d2a9-cb65-42ce-bd86-1274c3e5f705.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,85 mg/kg bw/day,,rat "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with ethanolamine",1962138-75-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e928c2a-d3e2-4e20-ac47-97e3229894b3/documents/88bdc4e0-7b15-4ea0-a5ef-df8abc9b5bcd_ac10d2a9-cb65-42ce-bd86-1274c3e5f705.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,500 mg/kg bw/day",,rat "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with ethanolamine",1962138-75-5," MEA-LAS dissociates into LAS and MEA in aqueous media and therefore the acute oral toxicity of both compounds has been studied. Results of the acute toxicity studies indicate that the lowest acute LD50 (oral) is 1080 mg/kg bw, whereas the lowest acute dermal LD50 is 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e928c2a-d3e2-4e20-ac47-97e3229894b3/documents/bb585076-9960-47c8-9637-39abae62282e_ac10d2a9-cb65-42ce-bd86-1274c3e5f705.html,,,,,, "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with ethanolamine",1962138-75-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e928c2a-d3e2-4e20-ac47-97e3229894b3/documents/bb585076-9960-47c8-9637-39abae62282e_ac10d2a9-cb65-42ce-bd86-1274c3e5f705.html,,oral,LD50,"1,080 mg/kg bw",adverse effect observed, "Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with ethanolamine",1962138-75-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e928c2a-d3e2-4e20-ac47-97e3229894b3/documents/bb585076-9960-47c8-9637-39abae62282e_ac10d2a9-cb65-42ce-bd86-1274c3e5f705.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "Benzenesulfonic acid, 4-dodecyl-, cerium(4+) salt, basic",84238-45-9," No acute toxicity studies with Benzenesulfonic acid, 4-dodecyl-, cerium(4+) salt, basic are available, thus the acute toxicity will be addressed with existing data on the dissociation products cerium and benzenesulfonic acid, 4-C10-13-sec-alkyl derivs.   Signs of acute oral toxicity are not expected for the assessment entity cerium, since the LD50 is greater than 2000 mg/kg bw. The oral LD50 value for the assessment entity benzenesulfonic acid, 4-C10-13-sec-alkyl derivs is 1470 mg/kg bw. The calculated oral LD50 forBenzenesulfonic acid, 4-dodecyl-, cerium(4+) salt, basicis >2000 mg/kg bw, thus the substance is not classified for acute oral toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fc3de13-c535-48a3-b5b4-c582b5b7db82/documents/3cba7c09-18a6-41bc-94a4-27bc341b8f20_5d119e63-672c-459d-8e68-2d3dfe563f26.html,,,,,, "2,6-dimethylphenyl 4-hydroxybenzenesulfonate",1364731-90-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): in vivo 28-day oral toxicity. K1 quality. Data generated in compliance with GLP ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/292e4bad-bb83-4f1a-aa0c-0d7a6c320c86/documents/IUC5-9166c509-b3d6-4d8c-bfd2-03e1caa1da87_5eb92258-0f7d-4649-9742-7cfcf892fc96.html,,,,,, "2,6-dimethylphenyl 4-hydroxybenzenesulfonate",1364731-90-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/292e4bad-bb83-4f1a-aa0c-0d7a6c320c86/documents/IUC5-9166c509-b3d6-4d8c-bfd2-03e1caa1da87_5eb92258-0f7d-4649-9742-7cfcf892fc96.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,6-dimethylphenyl 4-hydroxybenzenesulfonate",1364731-90-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): K1: Data have been generated according to current internationally recognised study guidelines and in accordance with GLP ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/292e4bad-bb83-4f1a-aa0c-0d7a6c320c86/documents/IUC5-5430effd-f424-4be9-ac59-10f93e28f9c0_5eb92258-0f7d-4649-9742-7cfcf892fc96.html,,,,,, "2,6-dimethylphenyl 4-hydroxybenzenesulfonate",1364731-90-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/292e4bad-bb83-4f1a-aa0c-0d7a6c320c86/documents/IUC5-5430effd-f424-4be9-ac59-10f93e28f9c0_5eb92258-0f7d-4649-9742-7cfcf892fc96.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, 4-mono-C20-24 (even numbered)-alkyl derivs., magnesium salts",231297-75-9," Read across: CAS 115733-09-0, One-generation reproductive toxicity study, rats, NOAEL > 500 mg/kg bw ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37239a2f-b16b-4d99-82a9-081a4399ebe5/documents/IUC5-f583b895-4858-4c1f-927a-51c04a60ca52_e5b5e561-0e65-4d1d-b657-b766b1452b45.html,,,,,, "Benzenesulfonic acid, 4-mono-C20-24 (even numbered)-alkyl derivs., magnesium salts",231297-75-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37239a2f-b16b-4d99-82a9-081a4399ebe5/documents/IUC5-f583b895-4858-4c1f-927a-51c04a60ca52_e5b5e561-0e65-4d1d-b657-b766b1452b45.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Benzenesulfonic acid, 4-mono-C20-24 (even numbered)-alkyl derivs., magnesium salts",231297-75-9,"Read across: Oral: LD50 > 16,000 mg/kg, ratsRead Across: Dermal: LD50 > 2000 mg/kg, rats, limit test ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37239a2f-b16b-4d99-82a9-081a4399ebe5/documents/IUC5-ecb8b9d8-36d5-43e2-b5db-c06442348565_e5b5e561-0e65-4d1d-b657-b766b1452b45.html,,,,,, "Benzenesulfonic acid, 4-mono-C20-24 (even numbered)-alkyl derivs., magnesium salts",231297-75-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37239a2f-b16b-4d99-82a9-081a4399ebe5/documents/IUC5-ecb8b9d8-36d5-43e2-b5db-c06442348565_e5b5e561-0e65-4d1d-b657-b766b1452b45.html,,oral,LD50,"16,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, 4-mono-C20-24 (even numbered)-alkyl derivs., magnesium salts",231297-75-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37239a2f-b16b-4d99-82a9-081a4399ebe5/documents/IUC5-ecb8b9d8-36d5-43e2-b5db-c06442348565_e5b5e561-0e65-4d1d-b657-b766b1452b45.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, C10-13-alkyl derivs., calcium salt",1335202-81-7,"Three separate repeated dose studies via oral exposure are reported.  In the first, the resultant LOAEL and NOAEL values were 250 and 125 mg/kg bw/day, respectively.  In the second, the resultant LOAEL and NOAEL values were 115 and 40 mg/kg bw/day, respectively. And in the third, the resultant LOAEL and NOAEL values were 145 and 85 mg/kg bw/day, respectively.  This latter NOAEL represents the highest NOAEL below the lowest LOAEL in all of the studies and is therefore the appropriate NOAEL for use in the assessment. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5278c615-b2f5-4c59-a334-61834b31bddb/documents/IUC5-79c05aa3-b2aa-4454-8303-11d22e505194_d450c916-35e1-4791-9ace-04a4b883c806.html,,,,,, "Benzenesulfonic acid, C10-13-alkyl derivs., calcium salt",1335202-81-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5278c615-b2f5-4c59-a334-61834b31bddb/documents/IUC5-79c05aa3-b2aa-4454-8303-11d22e505194_d450c916-35e1-4791-9ace-04a4b883c806.html,Chronic toxicity – systemic effects,oral,NOAEL,85 mg/kg bw/day,,rat "Benzenesulfonic acid, C10-13-alkyl derivs., calcium salt",1335202-81-7,"The acute toxicity of CaDDBS via oral exposures was tested in rats.  The acute dermal toxicity of the analogue NaLAS was also tested in rats. No acute toxicity was observed at doses exceeding the maximum limit doses for both the oral or dermal exposures. Therefore, CaDDBS is not classified either under the DSD or the CLP. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5278c615-b2f5-4c59-a334-61834b31bddb/documents/IUC5-983f144f-7196-4bf9-b86e-a12bceeed772_d450c916-35e1-4791-9ace-04a4b883c806.html,,,,,, "Benzenesulfonic acid, C10-13-alkyl derivs., calcium salt",1335202-81-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5278c615-b2f5-4c59-a334-61834b31bddb/documents/IUC5-983f144f-7196-4bf9-b86e-a12bceeed772_d450c916-35e1-4791-9ace-04a4b883c806.html,,oral,LD50,"4,445 mg/kg bw",, "Benzenesulfonic acid, C10-13-alkyl derivs., calcium salt",1335202-81-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5278c615-b2f5-4c59-a334-61834b31bddb/documents/IUC5-983f144f-7196-4bf9-b86e-a12bceeed772_d450c916-35e1-4791-9ace-04a4b883c806.html,,dermal,LD50,"2,000 mg/kg bw",, "Benzenesulfonic acid, C10-16-alkyl derivs.",68584-22-5,"The toxicity of the substance has been assessed by the repeated exposure over a period of 28-days by the three routes of exposure, oral, dermal and inhalation. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d075c0a-50f5-46d2-89d8-d1c3e1a2868f/documents/IUC5-e4f97147-c201-4509-92c7-ae2c42d171cb_c881fe9c-1d87-4d6c-b815-4f4706ee9f52.html,,,,,, "Benzenesulfonic acid, C10-16-alkyl derivs.",68584-22-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d075c0a-50f5-46d2-89d8-d1c3e1a2868f/documents/IUC5-e4f97147-c201-4509-92c7-ae2c42d171cb_c881fe9c-1d87-4d6c-b815-4f4706ee9f52.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Benzenesulfonic acid, C10-16-alkyl derivs.",68584-22-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d075c0a-50f5-46d2-89d8-d1c3e1a2868f/documents/IUC5-e4f97147-c201-4509-92c7-ae2c42d171cb_c881fe9c-1d87-4d6c-b815-4f4706ee9f52.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Benzenesulfonic acid, C10-16-alkyl derivs.",68584-22-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d075c0a-50f5-46d2-89d8-d1c3e1a2868f/documents/IUC5-e4f97147-c201-4509-92c7-ae2c42d171cb_c881fe9c-1d87-4d6c-b815-4f4706ee9f52.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,49.5 mg/m3,,rat "Benzenesulfonic acid, C10-16-alkyl derivs.",68584-22-5,"Acute mammalian toxicity in rats, exposed by the oral gavage, inhalation and dermal routes ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d075c0a-50f5-46d2-89d8-d1c3e1a2868f/documents/IUC5-378482ca-3351-4220-95d2-5ae4938aa42d_c881fe9c-1d87-4d6c-b815-4f4706ee9f52.html,,,,,, "Benzenesulfonic acid, C10-16-alkyl derivs.",68584-22-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d075c0a-50f5-46d2-89d8-d1c3e1a2868f/documents/IUC5-378482ca-3351-4220-95d2-5ae4938aa42d_c881fe9c-1d87-4d6c-b815-4f4706ee9f52.html,,oral,LD50,"5,000 mg/kg bw",, "Benzenesulfonic acid, C10-16-alkyl derivs.",68584-22-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d075c0a-50f5-46d2-89d8-d1c3e1a2868f/documents/IUC5-378482ca-3351-4220-95d2-5ae4938aa42d_c881fe9c-1d87-4d6c-b815-4f4706ee9f52.html,,dermal,LD50,"5,000 mg/kg bw",, "Benzenesulfonic acid, C10-16-alkyl derivs.",68584-22-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d075c0a-50f5-46d2-89d8-d1c3e1a2868f/documents/IUC5-378482ca-3351-4220-95d2-5ae4938aa42d_c881fe9c-1d87-4d6c-b815-4f4706ee9f52.html,,inhalation,LC50,1.9 mg/m3,, "Benzenesulfonic acid, C10-16-alkyl derivs., magnesium salts",68584-26-9,"The toxicity of the substance has been assessed by the repeated exposure over a period of 28-days by the three routes of exposure, oral, dermal and inhalation. Effects observed by oral exposure demonstrate a reduction in serum cholesterol at the highest tested dose. Furthermore, the results obtained by inhalation exposure are considered unsafe for determination of the intrinsic hazard of the substance by inhalation due to the a high proportion (65%) of mineral oil in the test sample. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8277999-00fd-4d53-b347-401c52615614/documents/IUC5-339a7fc7-f4ef-4b4c-8c08-91c8bd5fb0a8_c88d69ff-9dff-4773-8722-d3407e77dd44.html,,,,,, "Benzenesulfonic acid, C10-16-alkyl derivs., magnesium salts",68584-26-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8277999-00fd-4d53-b347-401c52615614/documents/IUC5-339a7fc7-f4ef-4b4c-8c08-91c8bd5fb0a8_c88d69ff-9dff-4773-8722-d3407e77dd44.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Benzenesulfonic acid, C10-16-alkyl derivs., magnesium salts",68584-26-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8277999-00fd-4d53-b347-401c52615614/documents/IUC5-339a7fc7-f4ef-4b4c-8c08-91c8bd5fb0a8_c88d69ff-9dff-4773-8722-d3407e77dd44.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Benzenesulfonic acid, C10-16-alkyl derivs., magnesium salts",68584-26-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8277999-00fd-4d53-b347-401c52615614/documents/IUC5-339a7fc7-f4ef-4b4c-8c08-91c8bd5fb0a8_c88d69ff-9dff-4773-8722-d3407e77dd44.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,881.58 mg/m3,,rat "Benzenesulfonic acid, C10-16-alkyl derivs., magnesium salts",68584-26-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8277999-00fd-4d53-b347-401c52615614/documents/IUC5-339a7fc7-f4ef-4b4c-8c08-91c8bd5fb0a8_c88d69ff-9dff-4773-8722-d3407e77dd44.html,Repeated dose toxicity – local effects,dermal,NOAEL,"1,000 mg/cm2",adverse effect observed,rat "Benzenesulfonic acid, C10-16-alkyl derivs., magnesium salts",68584-26-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8277999-00fd-4d53-b347-401c52615614/documents/IUC5-339a7fc7-f4ef-4b4c-8c08-91c8bd5fb0a8_c88d69ff-9dff-4773-8722-d3407e77dd44.html,Repeated dose toxicity – local effects,inhalation,NOAEC,881.58 mg/m3,adverse effect observed,rat "Benzenesulfonic acid, C10-16-alkyl derivs., magnesium salts",68584-26-9,"Acute mammalian toxicity in rats, exposed by the oral gavage, inhalation and dermal routes ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8277999-00fd-4d53-b347-401c52615614/documents/IUC5-1c491468-bc0e-464f-8565-5e67fcc603fb_c88d69ff-9dff-4773-8722-d3407e77dd44.html,,,,,, "Benzenesulfonic acid, C10-16-alkyl derivs., magnesium salts",68584-26-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8277999-00fd-4d53-b347-401c52615614/documents/IUC5-1c491468-bc0e-464f-8565-5e67fcc603fb_c88d69ff-9dff-4773-8722-d3407e77dd44.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, C10-16-alkyl derivs., magnesium salts",68584-26-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8277999-00fd-4d53-b347-401c52615614/documents/IUC5-1c491468-bc0e-464f-8565-5e67fcc603fb_c88d69ff-9dff-4773-8722-d3407e77dd44.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, C10-16-alkyl derivs., magnesium salts",68584-26-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8277999-00fd-4d53-b347-401c52615614/documents/IUC5-1c491468-bc0e-464f-8565-5e67fcc603fb_c88d69ff-9dff-4773-8722-d3407e77dd44.html,,inhalation,LC50,1.9 mg/m3,no adverse effect observed, "Benzenesulfonic acid, C10-60-alkyl derivs., barium salts",93028-28-5,"The toxicity of the substance has been assessed by the repeated exposure over a period of 28-days by the three routes of exposure, oral, dermal and inhalation.  Effects observed by oral exposure demonstrate a reduction in serum cholesterol at the highest tested dose.  Furthermore, the results obtained by inhalation exposure are considered unsafe for determination of the intrinsic hazard of the substance by inhalation due to the a high proportion (65%) of mineral oil in the test sample. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/50a15595-f47f-4a36-b2fc-bdb99a5cff79/documents/b4f824b3-ef81-41fa-b71b-d7ab68c6a7f5_86c39aa3-c246-4d16-b61c-f70ae7e9e68b.html,,,,,, "Benzenesulfonic acid, C10-60-alkyl derivs., barium salts",93028-28-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/50a15595-f47f-4a36-b2fc-bdb99a5cff79/documents/b4f824b3-ef81-41fa-b71b-d7ab68c6a7f5_86c39aa3-c246-4d16-b61c-f70ae7e9e68b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Benzenesulfonic acid, C10-60-alkyl derivs., barium salts",93028-28-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/50a15595-f47f-4a36-b2fc-bdb99a5cff79/documents/b4f824b3-ef81-41fa-b71b-d7ab68c6a7f5_86c39aa3-c246-4d16-b61c-f70ae7e9e68b.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Benzenesulfonic acid, C10-60-alkyl derivs., barium salts",93028-28-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/50a15595-f47f-4a36-b2fc-bdb99a5cff79/documents/b4f824b3-ef81-41fa-b71b-d7ab68c6a7f5_86c39aa3-c246-4d16-b61c-f70ae7e9e68b.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,881.58 mg/m3,,rat "Benzenesulfonic acid, C10-60-alkyl derivs., barium salts",93028-28-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/50a15595-f47f-4a36-b2fc-bdb99a5cff79/documents/b4f824b3-ef81-41fa-b71b-d7ab68c6a7f5_86c39aa3-c246-4d16-b61c-f70ae7e9e68b.html,Repeated dose toxicity – local effects,dermal,NOAEL,"1,000 mg/cm2",adverse effect observed,rat "Benzenesulfonic acid, C10-60-alkyl derivs., barium salts",93028-28-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/50a15595-f47f-4a36-b2fc-bdb99a5cff79/documents/b4f824b3-ef81-41fa-b71b-d7ab68c6a7f5_86c39aa3-c246-4d16-b61c-f70ae7e9e68b.html,Repeated dose toxicity – local effects,inhalation,NOAEC,881.58 mg/m3,adverse effect observed,rat "Benzenesulfonic acid, C10-60-alkyl derivs., barium salts",93028-28-5,"Acute mammalian toxicity in rats, exposed by the oral gavage, inhalation and dermal routes. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50a15595-f47f-4a36-b2fc-bdb99a5cff79/documents/1fd6d3a4-951c-407d-9332-f3806afe90fe_86c39aa3-c246-4d16-b61c-f70ae7e9e68b.html,,,,,, "Benzenesulfonic acid, C10-60-alkyl derivs., barium salts",93028-28-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50a15595-f47f-4a36-b2fc-bdb99a5cff79/documents/1fd6d3a4-951c-407d-9332-f3806afe90fe_86c39aa3-c246-4d16-b61c-f70ae7e9e68b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, C10-60-alkyl derivs., barium salts",93028-28-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50a15595-f47f-4a36-b2fc-bdb99a5cff79/documents/1fd6d3a4-951c-407d-9332-f3806afe90fe_86c39aa3-c246-4d16-b61c-f70ae7e9e68b.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, C10-60-alkyl derivs., barium salts",93028-28-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50a15595-f47f-4a36-b2fc-bdb99a5cff79/documents/1fd6d3a4-951c-407d-9332-f3806afe90fe_86c39aa3-c246-4d16-b61c-f70ae7e9e68b.html,,inhalation,LC50,1.9 mg/m3,no adverse effect observed, "Benzenesulfonic acid, C10-60-alkyl derivs., calcium salts",90194-27-7,"The toxicity of the substance has been assessed by the repeated exposure over a period of 28-days by the three routes of exposure, oral, dermal and inhalation. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bed2e17-0c91-4102-aca5-67e4d394420e/documents/IUC5-e4f97147-c201-4509-92c7-ae2c42d171cb_814fb4b9-51d8-426e-b50c-170d49f5851d.html,,,,,, "Benzenesulfonic acid, C10-60-alkyl derivs., calcium salts",90194-27-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bed2e17-0c91-4102-aca5-67e4d394420e/documents/IUC5-e4f97147-c201-4509-92c7-ae2c42d171cb_814fb4b9-51d8-426e-b50c-170d49f5851d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Benzenesulfonic acid, C10-60-alkyl derivs., calcium salts",90194-27-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bed2e17-0c91-4102-aca5-67e4d394420e/documents/IUC5-e4f97147-c201-4509-92c7-ae2c42d171cb_814fb4b9-51d8-426e-b50c-170d49f5851d.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Benzenesulfonic acid, C10-60-alkyl derivs., calcium salts",90194-27-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bed2e17-0c91-4102-aca5-67e4d394420e/documents/IUC5-e4f97147-c201-4509-92c7-ae2c42d171cb_814fb4b9-51d8-426e-b50c-170d49f5851d.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,49.5 mg/m3,,rat "Benzenesulfonic acid, C10-60-alkyl derivs., calcium salts",90194-27-7,"Acute mammalian toxicity in rats, exposed by the oral gavage, inhalation and dermal routes ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bed2e17-0c91-4102-aca5-67e4d394420e/documents/IUC5-378482ca-3351-4220-95d2-5ae4938aa42d_814fb4b9-51d8-426e-b50c-170d49f5851d.html,,,,,, "Benzenesulfonic acid, C10-60-alkyl derivs., calcium salts",90194-27-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bed2e17-0c91-4102-aca5-67e4d394420e/documents/IUC5-378482ca-3351-4220-95d2-5ae4938aa42d_814fb4b9-51d8-426e-b50c-170d49f5851d.html,,oral,LD50,"5,000 mg/kg bw",, "Benzenesulfonic acid, C10-60-alkyl derivs., calcium salts",90194-27-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bed2e17-0c91-4102-aca5-67e4d394420e/documents/IUC5-378482ca-3351-4220-95d2-5ae4938aa42d_814fb4b9-51d8-426e-b50c-170d49f5851d.html,,dermal,LD50,"5,000 mg/kg bw",, "Benzenesulfonic acid, C10-60-alkyl derivs., calcium salts",90194-27-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bed2e17-0c91-4102-aca5-67e4d394420e/documents/IUC5-378482ca-3351-4220-95d2-5ae4938aa42d_814fb4b9-51d8-426e-b50c-170d49f5851d.html,,inhalation,LC50,1.9 mg/m3,, "Benzenesulfonic acid, mono-C10-13-alkyl derivs., compds. with diethanolamine",90194-39-1, Based on experimental data available on two read-across substances the test item is classified as STOT RE 2 according to Regulation (EC) No 1272/2008. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3d99b0c-50f9-43aa-8dc2-b83d2f3cc8c5/documents/fdbae86b-d5d7-43e7-a946-28b57c31690d_fa2e48ff-22b9-4a9e-9296-979cacd26f4d.html,,,,,, "Benzenesulfonic acid, mono-C10-13-alkyl derivs., compds. with diethanolamine",90194-39-1,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3d99b0c-50f9-43aa-8dc2-b83d2f3cc8c5/documents/fdbae86b-d5d7-43e7-a946-28b57c31690d_fa2e48ff-22b9-4a9e-9296-979cacd26f4d.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,14 mg/kg bw/day,,rat "Benzenesulfonic acid, mono-C10-13-alkyl derivs., compds. with diethanolamine",90194-39-1," Acute toxicity of the test item is addressed by read-across approach. Based on experimental data available for all source substances, lowest LD50 of 1080 mg LAS Na/kg bw/ was obtained in rats via the oral route. Via the dermal route no adverse effects were observed at doses up to 2000 and 13000 mg/kg bw tested with LAS Na and DEA, respectively. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3d99b0c-50f9-43aa-8dc2-b83d2f3cc8c5/documents/a3b191d1-76df-49eb-9542-5d6039fccb73_fa2e48ff-22b9-4a9e-9296-979cacd26f4d.html,,,,,, "Benzenesulfonic acid, mono-C10-13-alkyl derivs., compds. with diethanolamine",90194-39-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3d99b0c-50f9-43aa-8dc2-b83d2f3cc8c5/documents/a3b191d1-76df-49eb-9542-5d6039fccb73_fa2e48ff-22b9-4a9e-9296-979cacd26f4d.html,,oral,LD50,"1,080 mg/kg bw",adverse effect observed, "Benzenesulfonic acid, mono-C10-13-alkyl derivs., compds. with diethanolamine",90194-39-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3d99b0c-50f9-43aa-8dc2-b83d2f3cc8c5/documents/a3b191d1-76df-49eb-9542-5d6039fccb73_fa2e48ff-22b9-4a9e-9296-979cacd26f4d.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, mono-C10-13-alkyl derivs., potassium salts",85480-57-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/886ae7cf-27bf-4f80-b9b2-b0bcf8773b98/documents/63d4b982-04a6-4f68-a32e-94543dc7d791_fa203844-6106-499e-9277-cefd4ccd7dbd.html,,oral,LD50,"1,080 mg/kg bw",adverse effect observed, "Benzenesulfonic acid, mono-C11-13-branched alkyl derivs.",68608-88-8," The key study (nine-month drinking water study in rats) reports the NOAEL value of 85 mg/kg bw/day based on activities of glutamate-oxalate transaminase and lactate dehydrogenase and renal Na,K-ATPase.  The NOAEL value of 85 mg/kg bw/day represents the highest NOAEL below the lowest LOAEL in all of the studies and is therefore the appropriate NOAEL for use in the assessment. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f73b79f0-8732-4712-9274-f786bf295b3c/documents/4f4c0208-d8a6-4571-840d-226850e29ff8_73e87acd-9621-4db8-9b90-2fcfa5bf5090.html,,,,,, "Benzenesulfonic acid, mono-C11-13-branched alkyl derivs.",68608-88-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f73b79f0-8732-4712-9274-f786bf295b3c/documents/4f4c0208-d8a6-4571-840d-226850e29ff8_73e87acd-9621-4db8-9b90-2fcfa5bf5090.html,Chronic toxicity – systemic effects,oral,NOAEL,85 mg/kg bw/day,,rat "Benzenesulfonic acid, mono-C11-13-branched alkyl derivs.",68608-88-8, Tests were conducted to compare the acute toxicity of sulfonic acid branched material (ABS) versus Linear (LAS). Results indicate they are comparable. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f73b79f0-8732-4712-9274-f786bf295b3c/documents/IUC5-56ebf4a9-a030-4deb-b194-27ada5e34ac9_73e87acd-9621-4db8-9b90-2fcfa5bf5090.html,,,,,, "Benzenesulfonic acid, mono-C11-13-branched alkyl derivs.",68608-88-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f73b79f0-8732-4712-9274-f786bf295b3c/documents/IUC5-56ebf4a9-a030-4deb-b194-27ada5e34ac9_73e87acd-9621-4db8-9b90-2fcfa5bf5090.html,,oral,LD50,520 mg/kg bw,, "Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., calcium salts",68953-96-8,Three repeated dose studies via oral exposure are reported. The NOAEL value of 85 mg/kg bw/day represents the highest NOAEL below the lowest LOAEL in all of the studies and is therefore the appropriate NOAEL for use in the assessment. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4eaf9484-b77d-4dd5-8d5f-876c2923c425/documents/IUC5-1358da84-506f-4c90-9117-1cad6005a825_66091b71-92f7-40a5-8559-15a8bc99c86e.html,,,,,, "Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., calcium salts",68953-96-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4eaf9484-b77d-4dd5-8d5f-876c2923c425/documents/IUC5-1358da84-506f-4c90-9117-1cad6005a825_66091b71-92f7-40a5-8559-15a8bc99c86e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,85 mg/kg bw/day,,rat "Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., calcium salts",68953-96-8,The acute toxicity of Branched CaDDBS via oral and dermal exposures was evaluated in rats. The acute oral LD50 was >2000 mg/kg bw.  The acute dermal LD50 was between 1000 and 1600 mg/kg bw (Geometric mean = 1265 mg/kg bw). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4eaf9484-b77d-4dd5-8d5f-876c2923c425/documents/IUC5-5f87d1e5-3035-43ee-9c65-e5e78990941a_66091b71-92f7-40a5-8559-15a8bc99c86e.html,,,,,, "Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., calcium salts",68953-96-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4eaf9484-b77d-4dd5-8d5f-876c2923c425/documents/IUC5-5f87d1e5-3035-43ee-9c65-e5e78990941a_66091b71-92f7-40a5-8559-15a8bc99c86e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., calcium salts",68953-96-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4eaf9484-b77d-4dd5-8d5f-876c2923c425/documents/IUC5-5f87d1e5-3035-43ee-9c65-e5e78990941a_66091b71-92f7-40a5-8559-15a8bc99c86e.html,,dermal,LD50,"1,265 mg/kg bw",adverse effect observed, "Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., sodium salts",68608-89-9,"The key study (nine-month drinking water study in rats) reports the NOAEL value of 85 mg/kg bw/day based on activities of glutamate-oxalate transaminase and lactate dehydrogenase and renal Na,K-ATPase.  The NOAEL value of 85 mg/kg bw/day represents the highest NOAEL below the lowest LOAEL in all of the studies and is therefore the appropriate NOAEL for use in the assessment. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d7d183a-22ef-4797-8466-25a3a11db650/documents/b8ed5079-f971-4b7d-97d2-9f5b67819c0b_fc00a5a0-3bed-4bbb-85d5-533b4d29f4ce.html,,,,,, "Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., sodium salts",68608-89-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d7d183a-22ef-4797-8466-25a3a11db650/documents/b8ed5079-f971-4b7d-97d2-9f5b67819c0b_fc00a5a0-3bed-4bbb-85d5-533b4d29f4ce.html,Chronic toxicity – systemic effects,oral,NOAEL,85 mg/kg bw/day,,rat "Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., sodium salts",68608-89-9,"Tests were conducted to compare the acute toxicity oral of BABS Na salt versus LAS. Results indicate they are comparable, supporting the use of LAS as an analogue.  BABS Na salt oral LD50=520 mg/kg bw; dermal LD50=1000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d7d183a-22ef-4797-8466-25a3a11db650/documents/d9ea0e09-6584-499c-b1ea-4d87ad03261f_fc00a5a0-3bed-4bbb-85d5-533b4d29f4ce.html,,,,,, "Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., sodium salts",68608-89-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d7d183a-22ef-4797-8466-25a3a11db650/documents/d9ea0e09-6584-499c-b1ea-4d87ad03261f_fc00a5a0-3bed-4bbb-85d5-533b4d29f4ce.html,,oral,LD50,520 mg/kg bw,adverse effect observed, "Benzenesulfonic acid, mono-C11-13-branched alkyl derivs., sodium salts",68608-89-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d7d183a-22ef-4797-8466-25a3a11db650/documents/d9ea0e09-6584-499c-b1ea-4d87ad03261f_fc00a5a0-3bed-4bbb-85d5-533b4d29f4ce.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, "Benzenesulfonyl isocyanate, 2-(trifluoromethyl)-",85813-73-6,Concerning the acute oral toxicity of 2-(Trifluoromethyl)benzenesulfonamide two in vivo studies were performed. One can be assessed as reliable without restriction. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70f223d7-1015-4105-996f-bf7864f42009/documents/IUC5-ec0ff26a-73e3-49a9-a4cb-24a48af11136_a07c14e4-b410-4c65-a10a-6778756f19a2.html,,,,,, Benzenesulphonamide,98-10-2, The substance is proposed to be classified as Acute toxicity Category 4. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b13e6bb2-32aa-425d-9cc4-80979afc72fd/documents/60b2a504-6e73-4f70-b62f-4d9252d7b438_bf4b6b62-8b8d-4081-9590-c653572076fa.html,,,,,, Benzenesulphonic acid,98-11-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0651423-713f-4bc7-9797-d9d7e21392a6/documents/4e0c1d7b-3058-4af8-a03a-d9f8f3ed3974_b7d4e6a4-515f-4fed-a004-400654c66559.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Benzenesulphonic acid,98-11-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0651423-713f-4bc7-9797-d9d7e21392a6/documents/6f8f2e79-748a-4084-9730-be4dffd182ca_b7d4e6a4-515f-4fed-a004-400654c66559.html,,oral,LD50,"1,410 mg/kg bw",no adverse effect observed, "benzhydryl (6R,7R)-7-[[(2Z)-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-trityloxyiminoacetyl]amino]-3-formyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate",376653-37-1, Acute toxicity: oral LD50 > 2000 mg/kg bw in female CRL:(WI) rats.   ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b37205c3-88b6-40dc-a250-36eddb7f5859/documents/5c02cf19-b012-4456-b7d1-f17458b65ed3_ae526f92-dcb5-4f6e-9c78-5e44cff09ca4.html,,,,,, "benzhydryl (6R,7R)-7-[[(2Z)-2-(5-amino-1,2,4-thiadiazol-3-yl)-2-trityloxyiminoacetyl]amino]-3-formyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate",376653-37-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b37205c3-88b6-40dc-a250-36eddb7f5859/documents/5c02cf19-b012-4456-b7d1-f17458b65ed3_ae526f92-dcb5-4f6e-9c78-5e44cff09ca4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzidine-2,2'-disulphonic acid",117-61-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Reliable with restriction ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea083152-fc13-418a-89fd-664d10f943db/documents/IUC5-e6b06235-e951-4e1e-b389-46e84a30fb6a_0f6eedf5-7861-4abd-a407-fa9c018c75fd.html,,,,,, "Benzidine-2,2'-disulphonic acid",117-61-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea083152-fc13-418a-89fd-664d10f943db/documents/IUC5-e6b06235-e951-4e1e-b389-46e84a30fb6a_0f6eedf5-7861-4abd-a407-fa9c018c75fd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,793.75 mg/kg bw/day,,rat "Benzidine-2,2'-disulphonic acid",117-61-3,"From the available data, it can be concluded that the chemical benzidine-2,2'-disulphonic acid is unlikely to exhibit acute toxicity by the oral, inhalation and dermal route ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea083152-fc13-418a-89fd-664d10f943db/documents/IUC5-06002aa9-b16e-4431-9614-9086b4afa8c2_0f6eedf5-7861-4abd-a407-fa9c018c75fd.html,,,,,, "Benzidine-2,2'-disulphonic acid",117-61-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea083152-fc13-418a-89fd-664d10f943db/documents/IUC5-06002aa9-b16e-4431-9614-9086b4afa8c2_0f6eedf5-7861-4abd-a407-fa9c018c75fd.html,,oral,LD50,"3,400 mg/kg bw",no adverse effect observed, "Benzidine-2,2'-disulphonic acid",117-61-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea083152-fc13-418a-89fd-664d10f943db/documents/IUC5-06002aa9-b16e-4431-9614-9086b4afa8c2_0f6eedf5-7861-4abd-a407-fa9c018c75fd.html,,dermal,LD50,"12,000 mg/kg bw",no adverse effect observed, Benzimidazole-2-thiol,583-39-1," Repeated dose toxicity: Oral Based on the data available, the No Observed Adverse Effect Level (NOAEL) for the test chemical was considered to be less than 2 mg/Kg bw using male and female rats. Hence the test chemical is likely to be toxic upon repeated exposure by oral route as per the criteria mentioned in CLP regulation. Repeated dose toxicity: inhalation Based on the data available, the Low Observed Adverse Effect Concentration (LOAEC) for the test chemical was considered to be 3.1 mg/m³ using male and female rats. Hence the test chemical is likely to be toxic upon repeated exposure by oral route as per the criteria mentioned in CLP regulation. Repeated dose toxicity: dermal The OECD study result for acute toxicity by the dermal route indicates the LD50 value to be greater than 2000 mg/kg body weight. Also considering the use of the chemical as anti-oxidant for natural rubber and latex and considering the volatility absorption by the dermal route is not considered to be significant. Thus, given the above considerations, it is assumed that test chemical shall not exhibit repeated dose toxicity by the dermal route. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db90ee66-7a62-45cd-aaf0-906c8b224ed2/documents/d0e0e573-cf85-43b5-923a-7c606ac03e72_d8ff483b-44c1-4e41-971b-9a93c493ddfa.html,,,,,, Benzimidazole-2-thiol,583-39-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db90ee66-7a62-45cd-aaf0-906c8b224ed2/documents/d0e0e573-cf85-43b5-923a-7c606ac03e72_d8ff483b-44c1-4e41-971b-9a93c493ddfa.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,2 mg/kg bw/day,,rat Benzimidazole-2-thiol,583-39-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db90ee66-7a62-45cd-aaf0-906c8b224ed2/documents/d0e0e573-cf85-43b5-923a-7c606ac03e72_d8ff483b-44c1-4e41-971b-9a93c493ddfa.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,3.1 mg/m3,,rat Benzimidazole-2-thiol,583-39-1," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is 300 mg/kg bw. The study concluded that the LD50 value is between >50 - ≤300 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 3” for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 4.66E-6 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db90ee66-7a62-45cd-aaf0-906c8b224ed2/documents/da9f5c25-55dd-4a31-b3e8-9911811a6523_d8ff483b-44c1-4e41-971b-9a93c493ddfa.html,,,,,, Benzimidazole-2-thiol,583-39-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db90ee66-7a62-45cd-aaf0-906c8b224ed2/documents/da9f5c25-55dd-4a31-b3e8-9911811a6523_d8ff483b-44c1-4e41-971b-9a93c493ddfa.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Benzimidazole-2-thiol,583-39-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db90ee66-7a62-45cd-aaf0-906c8b224ed2/documents/da9f5c25-55dd-4a31-b3e8-9911811a6523_d8ff483b-44c1-4e41-971b-9a93c493ddfa.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzo[rst]phenanthro[10,1,2-cde]pentaphene-9,18-dione, reaction products with 1-chlorododecane",2180952-76-3," Dose range finding study in rats - Oral, gavage OECD 422 in rats - Oral, gavage ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04371310-f18a-402e-b82a-0de7d1d0a0f7/documents/37f003ac-baf3-4f6f-b998-3021555e4d19_083b2e6f-7bff-4b64-9445-680075f26be0.html,,,,,, "Benzo[rst]phenanthro[10,1,2-cde]pentaphene-9,18-dione, reaction products with 1-chlorododecane",2180952-76-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04371310-f18a-402e-b82a-0de7d1d0a0f7/documents/37f003ac-baf3-4f6f-b998-3021555e4d19_083b2e6f-7bff-4b64-9445-680075f26be0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Benzo[rst]phenanthro[10,1,2-cde]pentaphene-9,18-dione, reaction products with 1-chlorododecane",2180952-76-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): good Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): good ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04371310-f18a-402e-b82a-0de7d1d0a0f7/documents/eb1f3209-a0df-408c-8b12-22638e70fefe_083b2e6f-7bff-4b64-9445-680075f26be0.html,,,,,, 2-(4-Phenylbenzoyl)benzoic acid,42797-18-2," Based on the results of the read across study, the systemic NOAEL of 100 mg/kg bw/day has been considered as the point of departure for hazard and risk assessment of the test substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35fa21dc-5aa0-4b6d-a70a-40d04df29c70/documents/f6796c1b-90c2-4419-941a-cf7c783d9db0_21990fa0-3e49-4ae8-877b-5f0de6f52477.html,,,,,, 2-(4-Phenylbenzoyl)benzoic acid,42797-18-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35fa21dc-5aa0-4b6d-a70a-40d04df29c70/documents/f6796c1b-90c2-4419-941a-cf7c783d9db0_21990fa0-3e49-4ae8-877b-5f0de6f52477.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 2-(4-Phenylbenzoyl)benzoic acid,42797-18-2," Based on the results of the acute studies, the test substance is considered to be of low acute toxicity via oral and dermal routes ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35fa21dc-5aa0-4b6d-a70a-40d04df29c70/documents/IUC5-753cef73-ca2e-4272-98d2-656a347f9ae3_21990fa0-3e49-4ae8-877b-5f0de6f52477.html,,,,,, 2-(4-Phenylbenzoyl)benzoic acid,42797-18-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35fa21dc-5aa0-4b6d-a70a-40d04df29c70/documents/IUC5-753cef73-ca2e-4272-98d2-656a347f9ae3_21990fa0-3e49-4ae8-877b-5f0de6f52477.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-(4-Phenylbenzoyl)benzoic acid,42797-18-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35fa21dc-5aa0-4b6d-a70a-40d04df29c70/documents/IUC5-753cef73-ca2e-4272-98d2-656a347f9ae3_21990fa0-3e49-4ae8-877b-5f0de6f52477.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Mixture of octachloro, monomethoxy-heptachloro and bismethoxy-hexachloro derivatives of 3,3'-[(2-methyl-1,3-phenylene)diimino]bis[2,3-dihydro-1H-isoindol-1-one]",106276-79-3, study according to OECD TG 422 (GLP) with a structural analogue (CAS 30125-47-4) in rats: NOAEL = 1000 mg/kg bw/d ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/026f3960-d17e-49fa-89b0-676e2ad316bc/documents/IUC5-4d1dd9f3-7103-44d7-b5fe-4c20c4be95d4_da869d7b-fcd2-49ad-a111-f712091a5801.html,,,,,, "Mixture of octachloro, monomethoxy-heptachloro and bismethoxy-hexachloro derivatives of 3,3'-[(2-methyl-1,3-phenylene)diimino]bis[2,3-dihydro-1H-isoindol-1-one]",106276-79-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/026f3960-d17e-49fa-89b0-676e2ad316bc/documents/IUC5-4d1dd9f3-7103-44d7-b5fe-4c20c4be95d4_da869d7b-fcd2-49ad-a111-f712091a5801.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Mixture of octachloro, monomethoxy-heptachloro and bismethoxy-hexachloro derivatives of 3,3'-[(2-methyl-1,3-phenylene)diimino]bis[2,3-dihydro-1H-isoindol-1-one]",106276-79-3," Oral - Non-guideline study (equivalent or similar to OECD TG 401, pre-GLP) in rats: LD50 > 5000 mg/kg bw; Inhalation - Non-guideline study (equivalent or similar to OECD TG 403, pre-GLP) with a structural analogue (CAS 106276-80-6) in rats: LC50 > 1.04 mg/L air (highest technically attainable concentration) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/026f3960-d17e-49fa-89b0-676e2ad316bc/documents/IUC5-2530c6c9-b5b7-40f3-863d-89866d45e891_da869d7b-fcd2-49ad-a111-f712091a5801.html,,,,,, "Mixture of octachloro, monomethoxy-heptachloro and bismethoxy-hexachloro derivatives of 3,3'-[(2-methyl-1,3-phenylene)diimino]bis[2,3-dihydro-1H-isoindol-1-one]",106276-79-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/026f3960-d17e-49fa-89b0-676e2ad316bc/documents/IUC5-2530c6c9-b5b7-40f3-863d-89866d45e891_da869d7b-fcd2-49ad-a111-f712091a5801.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Mixture of octachloro, monomethoxy-heptachloro and bismethoxy-hexachloro derivatives of 3,3'-[(2-methyl-1,3-phenylene)diimino]bis[2,3-dihydro-1H-isoindol-1-one]",106276-79-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/026f3960-d17e-49fa-89b0-676e2ad316bc/documents/IUC5-2530c6c9-b5b7-40f3-863d-89866d45e891_da869d7b-fcd2-49ad-a111-f712091a5801.html,,inhalation,discriminating conc.,"1,000 mg/m3",no adverse effect observed, "Benzoic acid, 2,3,4,5-tetrachloro-6-cyano-, methyl ester, reaction products with 4-[2-(4-aminophenyl)diazenyl]-3-methylbenzenamine and methanol sodium salt (1:1)",106276-78-2,"Subacute toxicity was evaluated in a combined repeated dose toxicity / screening for reprotoxicity study according OECD 422 and GLP on an analogue substance. Male and female rats were exposed orally to 100, 300 or 1000 mg/kg bw of the compound for 28d. All animals survived until scheduled necropsy; signs of systemic toxicity or changes in organs and tissues were not observed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/469b09c3-aa82-42dc-8e3c-eae3618cf167/documents/7aad85c4-2708-4414-828d-9b9a4c1d5443_0bb676c0-b5c1-4ba3-929c-bd4c41c92c70.html,,,,,, "Benzoic acid, 2,3,4,5-tetrachloro-6-cyano-, methyl ester, reaction products with 4-[2-(4-aminophenyl)diazenyl]-3-methylbenzenamine and methanol sodium salt (1:1)",106276-78-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/469b09c3-aa82-42dc-8e3c-eae3618cf167/documents/7aad85c4-2708-4414-828d-9b9a4c1d5443_0bb676c0-b5c1-4ba3-929c-bd4c41c92c70.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Benzoic acid, 2,3,4,5-tetrachloro-6-cyano-, methyl ester, reaction products with 4-[2-(4-aminophenyl)diazenyl]-3-methylbenzenamine and methanol sodium salt (1:1)",106276-78-2,"Oral or inhalative administration of the test material / analogue did not cause mortalities, organ changes or clinical signs of toxicity. Therefore, LD50 oral is considered to be greater than 6000 mg/kg bw and LC50 greater than 1000 mg/m3. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/469b09c3-aa82-42dc-8e3c-eae3618cf167/documents/6a5b929c-2762-4b11-9ab4-ead4d8020574_0bb676c0-b5c1-4ba3-929c-bd4c41c92c70.html,,,,,, "Benzoic acid, 2,3,4,5-tetrachloro-6-cyano-, methyl ester, reaction products with 4-[2-(4-aminophenyl)diazenyl]-3-methylbenzenamine and methanol sodium salt (1:1)",106276-78-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/469b09c3-aa82-42dc-8e3c-eae3618cf167/documents/6a5b929c-2762-4b11-9ab4-ead4d8020574_0bb676c0-b5c1-4ba3-929c-bd4c41c92c70.html,,oral,discriminating dose,"6,000 mg/kg bw",no adverse effect observed, "Benzoic acid, 2,3,4,5-tetrachloro-6-cyano-, methyl ester, reaction products with 4-[2-(4-aminophenyl)diazenyl]-3-methylbenzenamine and methanol sodium salt (1:1)",106276-78-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/469b09c3-aa82-42dc-8e3c-eae3618cf167/documents/6a5b929c-2762-4b11-9ab4-ead4d8020574_0bb676c0-b5c1-4ba3-929c-bd4c41c92c70.html,,inhalation,discriminating conc.,"1,000 mg/m3",no adverse effect observed, "Mixture of octachloro, monomethoxy-heptachloro and bismethoxy-hexachloro derivatives of 3,3'-(1,4-phenylenedinitrilo)bis[2,3-dihydro-1H-isoindol-1-one]",106276-80-6,"- Oral: according to OECD 422, GLP, rat, NOAEL (for general systemic toxicity) 1000 mg/kg bw/d - Inhalation: according to OECD 412, GLP, rat, 5-day treatment with 21 days recovery, NOAEC (for systemic effects) 30 mg/m^3 air, NOAEC (for local effects) 10 mg/m^3 air Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): According to OECD TG 412, GLP, Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): According to OECD TG 412, GLP, Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): According to OECD TG 422, GLP, Klimisch 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7f5ab50a-7e69-4ff9-9694-0f2d2b16131e/documents/2480d9d9-edc5-43f4-804e-edf867df492e_ef66622e-2209-423a-bc53-f1bb799f4b7f.html,,,,,, "Mixture of octachloro, monomethoxy-heptachloro and bismethoxy-hexachloro derivatives of 3,3'-(1,4-phenylenedinitrilo)bis[2,3-dihydro-1H-isoindol-1-one]",106276-80-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7f5ab50a-7e69-4ff9-9694-0f2d2b16131e/documents/2480d9d9-edc5-43f4-804e-edf867df492e_ef66622e-2209-423a-bc53-f1bb799f4b7f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Mixture of octachloro, monomethoxy-heptachloro and bismethoxy-hexachloro derivatives of 3,3'-(1,4-phenylenedinitrilo)bis[2,3-dihydro-1H-isoindol-1-one]",106276-80-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7f5ab50a-7e69-4ff9-9694-0f2d2b16131e/documents/2480d9d9-edc5-43f4-804e-edf867df492e_ef66622e-2209-423a-bc53-f1bb799f4b7f.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat "Mixture of octachloro, monomethoxy-heptachloro and bismethoxy-hexachloro derivatives of 3,3'-(1,4-phenylenedinitrilo)bis[2,3-dihydro-1H-isoindol-1-one]",106276-80-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7f5ab50a-7e69-4ff9-9694-0f2d2b16131e/documents/2480d9d9-edc5-43f4-804e-edf867df492e_ef66622e-2209-423a-bc53-f1bb799f4b7f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,10 mg/m3,adverse effect observed,rat "Mixture of octachloro, monomethoxy-heptachloro and bismethoxy-hexachloro derivatives of 3,3'-(1,4-phenylenedinitrilo)bis[2,3-dihydro-1H-isoindol-1-one]",106276-80-6,"- Oral: similar to OECD guideline 401, prior GLP, LD50 (rat) >5000 mg/kg bw (no mortality or signs of toxicity) - Inhalation: similar to OECD guideline 403, prior GLP, LC50 (rat) >1.04 mg/L (no mortality or signs of toxicity) - Dermal: read across to CAS 30125-47-4, similar to OECD guideline 402, prior GLP, LD50 (rat) >2500 mg/kg bw (no mortality or signs of toxicity) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Similiar to OECD 401, pre-GLP, Klimisch 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Similiar to OECD 403, pre-GLP, Klimisch 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Read across to CAS 30125-47-4, similiar to OECD 402, pre-GLP, Klimisch 2 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f5ab50a-7e69-4ff9-9694-0f2d2b16131e/documents/fff03736-e7ea-49a9-8ccc-174012a1157e_ef66622e-2209-423a-bc53-f1bb799f4b7f.html,,,,,, "Mixture of octachloro, monomethoxy-heptachloro and bismethoxy-hexachloro derivatives of 3,3'-(1,4-phenylenedinitrilo)bis[2,3-dihydro-1H-isoindol-1-one]",106276-80-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f5ab50a-7e69-4ff9-9694-0f2d2b16131e/documents/fff03736-e7ea-49a9-8ccc-174012a1157e_ef66622e-2209-423a-bc53-f1bb799f4b7f.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Mixture of octachloro, monomethoxy-heptachloro and bismethoxy-hexachloro derivatives of 3,3'-(1,4-phenylenedinitrilo)bis[2,3-dihydro-1H-isoindol-1-one]",106276-80-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f5ab50a-7e69-4ff9-9694-0f2d2b16131e/documents/fff03736-e7ea-49a9-8ccc-174012a1157e_ef66622e-2209-423a-bc53-f1bb799f4b7f.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "Mixture of octachloro, monomethoxy-heptachloro and bismethoxy-hexachloro derivatives of 3,3'-(1,4-phenylenedinitrilo)bis[2,3-dihydro-1H-isoindol-1-one]",106276-80-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f5ab50a-7e69-4ff9-9694-0f2d2b16131e/documents/fff03736-e7ea-49a9-8ccc-174012a1157e_ef66622e-2209-423a-bc53-f1bb799f4b7f.html,,inhalation,discriminating conc.,"1,041 mg/m3",no adverse effect observed, methyl 2-{[(4-hydroxyphenyl)sulfonyl]oxy}benzoate,1432505-97-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): in vivo 28-day oral toxicity. K1 quality. Data generated in compliance with GLP ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3275ecd-f511-4d42-9e31-ad647d9d757b/documents/IUC5-1c67f8dc-7255-44a3-985f-285443f23587_4c7c4140-82eb-4103-8ae3-68136046edee.html,,,,,, methyl 2-{[(4-hydroxyphenyl)sulfonyl]oxy}benzoate,1432505-97-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3275ecd-f511-4d42-9e31-ad647d9d757b/documents/IUC5-1c67f8dc-7255-44a3-985f-285443f23587_4c7c4140-82eb-4103-8ae3-68136046edee.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat methyl 2-{[(4-hydroxyphenyl)sulfonyl]oxy}benzoate,1432505-97-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): K1: Data have been generated according to current internationally recognised study guidelines and in accordance with GLP ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3275ecd-f511-4d42-9e31-ad647d9d757b/documents/IUC5-cf4fe208-e0eb-42db-9de4-01f5eab50584_4c7c4140-82eb-4103-8ae3-68136046edee.html,,,,,, methyl 2-{[(4-hydroxyphenyl)sulfonyl]oxy}benzoate,1432505-97-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3275ecd-f511-4d42-9e31-ad647d9d757b/documents/IUC5-cf4fe208-e0eb-42db-9de4-01f5eab50584_4c7c4140-82eb-4103-8ae3-68136046edee.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzoic acid, 2-[[3-(trifluoromethyl)phenyl]amino]-, butyl ester",67330-25-0,"No internal repeated dose toxicity studies of Flufenaminsäurebutylester are available. Results of repeated dose toxicity studies are cited in RTECS database (May 2011):Oral, 31 days and 31 days recovery (rat): NOAEL = 60 mg/kg/day(Oyo Yakuri. Pharmacometrics (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-81, Japan) V.1- 1967- v. 18, p. 597, 1979 (OYYAA2))Dermal, 3 months and 6 weeks recovery (rat): NOAEL = 100 mg/kg/day(Oyo Yakuri. Pharmacometrics (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-81, Japan) V.1- 1967- v. 18, p. 943, 1979 (OYYAA2))Additionally, results of a further repeated dose toxicity study are published in the literature (May 2011)Oral, 6 months and 1 month recovery (rat): NOAEL = 30 mg/kg/day(Oyo Yakuri. Pharmacometrics (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-81, Japan) V.1- 1967- v. 19, p. 455, 1980 (OYYAA2)) ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/143518fc-04c3-4188-9b1a-e7f97affadbd/documents/IUC5-97a5be22-1025-4fa3-9edb-2aa7fd093796_ebc45403-6472-4df9-bbf3-5a3d737d8ba5.html,,,,,, "Benzoic acid, 2-[[3-(trifluoromethyl)phenyl]amino]-, butyl ester",67330-25-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/143518fc-04c3-4188-9b1a-e7f97affadbd/documents/IUC5-97a5be22-1025-4fa3-9edb-2aa7fd093796_ebc45403-6472-4df9-bbf3-5a3d737d8ba5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat "Benzoic acid, 2-[[3-(trifluoromethyl)phenyl]amino]-, butyl ester",67330-25-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/143518fc-04c3-4188-9b1a-e7f97affadbd/documents/IUC5-97a5be22-1025-4fa3-9edb-2aa7fd093796_ebc45403-6472-4df9-bbf3-5a3d737d8ba5.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,,rat "Benzoic acid, 2-[[3-(trifluoromethyl)phenyl]amino]-, butyl ester",67330-25-0,"Oral (Rat-Wistar): LD50 males = 1020 mg/kg, LD50 females = 1680 mg/kg (suspended in peanut oil)[Toxikologisches Institut für Troponwerke, Scientific Report No. 10532, 1981-06-04]Additionally results of acute toxicity studies with Flufenaminsäurebutylester (Butyl flufenamate) suspended in 1% carboxymethylcellulose are cited in RTECS database (May 2011) and can be found in (Oyo Yakuri. Pharmacometrics (Oyo Yakuri Kenkyukai, CPO Box 180, Sendai 980-81, Japan) V.1- 1967- v. 18, p. 845, 1979 (OYYAA2)):Oral (rat): LD50 = 510 mg/kgOral (mouse): LD50 = 3100 mg/kgOral (dog): LD50 > 16000 mg/kgOral (rabbit): LD50 = 4800 mg/kgDermal (rat): LD50 > 5000 mg/kgDermal (mouse): LD50 > 3000 mg/kgDermal (dog): LD50 > 1000 mg/kgDermal (rabbit): LD50 > 4000 mg/kgIntraperitoneal (rat): LD50 = 4550 mg/kgIntraperitoneal (mouse): LD50 = 4100 mg/kgIntraperitoneal (dog): LD50 = 1500 mg/kgIntraperitoneal (rabbit): LD50 = 11500 mg/kgSubcutaneous (rat): LD50 > 5000 mg/kgSubcutaneous (mouse): LD50 > 10000 mg/kgSubcutaneous (dog): LD50 = 9300 mg/kgSubcutaneous (rabbit): LD50 > 10000 mg/kgIntravenous (rat): LD50 = 650 mg/kgIntravenous (mouse): LD50 = 610 mg/kg ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/143518fc-04c3-4188-9b1a-e7f97affadbd/documents/IUC5-eba22868-4ec0-4661-ade0-8361743cb002_ebc45403-6472-4df9-bbf3-5a3d737d8ba5.html,,,,,, "3-[(2E)-2-benzylidenehydrazino]-4-sulfonatobenzoate, disodium salt",118969-29-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe07b096-5963-4bf2-98c4-bb46adadc903/documents/IUC5-d97fa3f4-e4ab-4867-97ef-ef4f4a130f49_d478501e-02ee-433e-a574-c00eb4a709e7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzoic acid, 2-hydroxy-, mono-C14-18-alkyl derivs., calcium salts (2:1)",114959-46-5,"GLP study reporting an oral NOAEL of 100 mg/kg/day in the rat (OECD 408, read-across substance, data considered applicable by ECHA). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fee9dab-1be1-4205-a102-059660e028b1/documents/IUC5-5b7efb89-2768-4c45-990e-61589e5863cd_dec54a39-8638-4577-bf00-ece09a479cc3.html,,,,,, "Benzoic acid, 2-hydroxy-, mono-C14-18-alkyl derivs., calcium salts (2:1)",114959-46-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fee9dab-1be1-4205-a102-059660e028b1/documents/IUC5-5b7efb89-2768-4c45-990e-61589e5863cd_dec54a39-8638-4577-bf00-ece09a479cc3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Benzoic acid, 2-hydroxy-, mono-C14-18-alkyl derivs., calcium salts (2:1)",114959-46-5,GLP study reporting acute oral LD50 in fasted rats > 5000 mg/kg (OECD 401)GLP study reporting acute dermal LD50 in rats > 2000 mg/kg (OECD 402) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fee9dab-1be1-4205-a102-059660e028b1/documents/IUC5-57a5dbc2-6550-4ee1-b0b4-f7f4653f776b_dec54a39-8638-4577-bf00-ece09a479cc3.html,,,,,, "Benzoic acid, 2-hydroxy-, mono-C14-18-alkyl derivs., calcium salts (2:1)",114959-46-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fee9dab-1be1-4205-a102-059660e028b1/documents/IUC5-57a5dbc2-6550-4ee1-b0b4-f7f4653f776b_dec54a39-8638-4577-bf00-ece09a479cc3.html,,oral,LD50,"5,000 mg/kg bw",, "Benzoic acid, 2-hydroxy-, mono-C14-18-alkyl derivs., calcium salts (2:1)",114959-46-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fee9dab-1be1-4205-a102-059660e028b1/documents/IUC5-57a5dbc2-6550-4ee1-b0b4-f7f4653f776b_dec54a39-8638-4577-bf00-ece09a479cc3.html,,dermal,LD50,"2,000 mg/kg bw",, "Benzoic acid, 2-hydroxy-, reaction products with formaldehyde, coupled with diazotized 5-amino-8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-2-naphthalenesulfonic acid disodium salt",72245-24-0," LD50 (oral, rat) ca. 5000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a0865a3-2d0a-41d4-835e-895549b339a5/documents/72bba33f-4d1c-42d5-bfbf-60c5431fd283_801748de-d529-4641-b059-56362322b58c.html,,,,,, "Benzoic acid, 2-hydroxy-, reaction products with formaldehyde, coupled with diazotized 5-amino-8-[[4-[(4-nitro-2-sulfophenyl)amino]phenyl]azo]-2-naphthalenesulfonic acid disodium salt",72245-24-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a0865a3-2d0a-41d4-835e-895549b339a5/documents/72bba33f-4d1c-42d5-bfbf-60c5431fd283_801748de-d529-4641-b059-56362322b58c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Benzoic acid, 2-hydroxy-5-[[4-[[4-[[8-hydroxy-7-[[4-[(8-hydroxy-3,6-disulfo-1-naphthalenyl)azo]-2-methoxy-5-methylphenyl]azo]-3,6-disulfo-1-naphthalenyl]amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]phenyl]azo]-, pentasodium salt",6388-26-7, LD50 = 3800 mg/kg in rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00cde79d-6c55-40f4-922c-3bc4a5fa7be2/documents/e7116b66-20a5-4489-a67a-99b7f42a5a38_52ccf0d2-dc03-47f4-9773-d30faddca0d8.html,,,,,, "Benzoic acid, 2-hydroxy-5-[[4-[[4-[[8-hydroxy-7-[[4-[(8-hydroxy-3,6-disulfo-1-naphthalenyl)azo]-2-methoxy-5-methylphenyl]azo]-3,6-disulfo-1-naphthalenyl]amino]-6-(phenylamino)-1,3,5-triazin-2-yl]amino]phenyl]azo]-, pentasodium salt",6388-26-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00cde79d-6c55-40f4-922c-3bc4a5fa7be2/documents/e7116b66-20a5-4489-a67a-99b7f42a5a38_52ccf0d2-dc03-47f4-9773-d30faddca0d8.html,,oral,LD50,"3,800 mg/kg bw",adverse effect observed, "3,5-diamino-4-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-2-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]benzoic acid sodium salt",906532-68-1,The NOAEL of Everzol Orange ED-G Crude is equal to or more than 1000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb64497c-df36-47ba-80b4-5c77502b9911/documents/IUC5-2bee835b-6c00-4c5c-a026-9f61e720bd05_6cf28d90-4992-442f-b50c-37662dc09efd.html,,,,,, "3,5-diamino-4-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-2-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]benzoic acid sodium salt",906532-68-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb64497c-df36-47ba-80b4-5c77502b9911/documents/IUC5-2bee835b-6c00-4c5c-a026-9f61e720bd05_6cf28d90-4992-442f-b50c-37662dc09efd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,5-diamino-4-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-2-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]benzoic acid sodium salt",906532-68-1,LD 50 oral rat > 2000 mg/kg bw; LD 50 dermal rat > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb64497c-df36-47ba-80b4-5c77502b9911/documents/IUC5-34ffcb10-1f08-473b-9079-772c0a3cf667_6cf28d90-4992-442f-b50c-37662dc09efd.html,,,,,, "3,5-diamino-4-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-2-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]benzoic acid sodium salt",906532-68-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb64497c-df36-47ba-80b4-5c77502b9911/documents/IUC5-34ffcb10-1f08-473b-9079-772c0a3cf667_6cf28d90-4992-442f-b50c-37662dc09efd.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,5-diamino-4-[[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]-2-[[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]benzoic acid sodium salt",906532-68-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb64497c-df36-47ba-80b4-5c77502b9911/documents/IUC5-34ffcb10-1f08-473b-9079-772c0a3cf667_6cf28d90-4992-442f-b50c-37662dc09efd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "rac-N-(2,3-Dihydroxypropyl)-5-nitroisophthalamic acid",122731-58-2,"Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg [Schering AG, Report No. X085 -draft-, 1996-05-05] Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg [Schering AG, Report No. X111 -draft-, 1996-09-25]   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch score 2 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a313e238-ef72-4cfe-944e-bf6ef0307001/documents/IUC5-24250289-e9b2-48dc-9f33-e2b0dba67e54_89b7322e-775a-43a6-83a1-d8f891d5e51a.html,,,,,, "rac-N-(2,3-Dihydroxypropyl)-5-nitroisophthalamic acid",122731-58-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a313e238-ef72-4cfe-944e-bf6ef0307001/documents/IUC5-24250289-e9b2-48dc-9f33-e2b0dba67e54_89b7322e-775a-43a6-83a1-d8f891d5e51a.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "rac-N-(2,3-Dihydroxypropyl)-5-nitroisophthalamic acid",122731-58-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a313e238-ef72-4cfe-944e-bf6ef0307001/documents/IUC5-24250289-e9b2-48dc-9f33-e2b0dba67e54_89b7322e-775a-43a6-83a1-d8f891d5e51a.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "rac-5-Amino-N-(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamic acid",111453-32-8,"Oral (Rat, GLP): LD50 > 2000 mg/kg [Schering AG, Report No. A860, 1994-01-12] Dermal (Rat, GLP): LD50 > 2000 mg/kg [Schering AG, Report No. X192, 1997-01-08] Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0cf9b232-ea9a-4aa3-9948-06d282b3a480/documents/IUC5-5106f9fd-776a-4d9d-a707-6ac6a9675b02_5e0b07c6-ca35-4f23-88be-a1eb88e284b5.html,,,,,, "rac-5-Amino-N-(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamic acid",111453-32-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0cf9b232-ea9a-4aa3-9948-06d282b3a480/documents/IUC5-5106f9fd-776a-4d9d-a707-6ac6a9675b02_5e0b07c6-ca35-4f23-88be-a1eb88e284b5.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "rac-5-Amino-N-(2,3-dihydroxypropyl)-2,4,6-triiodoisophthalamic acid",111453-32-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0cf9b232-ea9a-4aa3-9948-06d282b3a480/documents/IUC5-5106f9fd-776a-4d9d-a707-6ac6a9675b02_5e0b07c6-ca35-4f23-88be-a1eb88e284b5.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "rac-5-Amino-N-(2,3-diacetoxypropyl)-2,4,6-triiodoisophthalamic acid",122731-59-3,"Oral (Rat, GLP): LD50 > 2000 mg/kg [Schering AG, Report No. draft, 1993-06-03]Dermal (Rat, GLP): LD50 > 200 mg/kg < 2000 mg/kg [Schering AG, Report No. draft, 1994-07-06] Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch score 2 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ab37a04-e790-42ef-b068-8f2049d3c21b/documents/IUC5-840f6e37-1bf7-4308-9126-f44fce76f46b_eb9f329e-e527-4efe-a164-cb7a8e5d2675.html,,,,,, "rac-5-Amino-N-(2,3-diacetoxypropyl)-2,4,6-triiodoisophthalamic acid",122731-59-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ab37a04-e790-42ef-b068-8f2049d3c21b/documents/IUC5-840f6e37-1bf7-4308-9126-f44fce76f46b_eb9f329e-e527-4efe-a164-cb7a8e5d2675.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "rac-5-Amino-N-(2,3-diacetoxypropyl)-2,4,6-triiodoisophthalamic acid",122731-59-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ab37a04-e790-42ef-b068-8f2049d3c21b/documents/IUC5-840f6e37-1bf7-4308-9126-f44fce76f46b_eb9f329e-e527-4efe-a164-cb7a8e5d2675.html,,dermal,LD50,> 200 mg/kg bw,adverse effect observed, "Benzoic acid, 4-[ (1-oxodecyl) oxy]-",86960-46-5,"Oral administration to Wistar rats at doses of 50, 200 and 1000 mg/kg/day, for 28 days resulted in no deaths, no clinical symptoms after daily and weekly (weeks 1, 2 and 3) observations, no clinical symptoms during the functional observational battery, no effects on food consumption or body weight development, no effects upon hematology, clinical biochemistry or urinalysis parameters, no changes in mean absolute or relative organ weights, no effects upon sperm motility, morphology and count, and no macroscopical or microscopical findings of toxicological relevance. Based on the results of this study, 1000 mg/kg body weight/day was established as the no-observed-effect-level (NOEL) and as the no-observed-adverse-effect-level (NOAEL) for DOBA. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c5112a0-617b-417f-940c-d7f50168a274/documents/IUC5-de7be52b-3858-4ac5-9fb6-24e971588712_57fd7d66-80bd-4bdf-aef3-388c0e4981e9.html,,,,,, "Benzoic acid, 4-[ (1-oxodecyl) oxy]-",86960-46-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c5112a0-617b-417f-940c-d7f50168a274/documents/IUC5-de7be52b-3858-4ac5-9fb6-24e971588712_57fd7d66-80bd-4bdf-aef3-388c0e4981e9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Benzoic acid, 4-[ (1-oxodecyl) oxy]-",86960-46-5,Acute oral toxicity:The test item did not cause any mortality or clinical signs or necropsy findings after single oral gavage administration to female rats at 2000 mg/kg bw in a GLP compliant guideline study. The LD50 (female rat) was greater than 2000 mg/kg body weight.Acute dermal toxicity:The test item did not cause any mortality or clinical signs or necropsy findings after single dermal administration to male and female rats at 2000 mg/kg bw in a GLP compliant guideline study. The LD50 (male/female rat) was greater than 2000 mg/kg body weight. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c5112a0-617b-417f-940c-d7f50168a274/documents/IUC5-15301ef4-8639-4b12-a992-8136e5353017_57fd7d66-80bd-4bdf-aef3-388c0e4981e9.html,,,,,, "Benzoic acid, 4-[ (1-oxodecyl) oxy]-",86960-46-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c5112a0-617b-417f-940c-d7f50168a274/documents/IUC5-15301ef4-8639-4b12-a992-8136e5353017_57fd7d66-80bd-4bdf-aef3-388c0e4981e9.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Benzoic acid, 4-[ (1-oxodecyl) oxy]-",86960-46-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c5112a0-617b-417f-940c-d7f50168a274/documents/IUC5-15301ef4-8639-4b12-a992-8136e5353017_57fd7d66-80bd-4bdf-aef3-388c0e4981e9.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Monoazo Orange Pigment,250640-08-5," Analogue substance EC No. 427-930-3oral: 28 d, rat, gavage: NOAEL systemic ≥ 1000 mg/kg bw/d (Safepharm Laboratories Ltd. 1235/113, 1999) Substance itself: No adverse effects were noted in the screening study for reproductive toxicity (OECD 421, GLP) up to the limit dose of 1000 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2bcce236-eff8-4c78-8a7e-581239961e69/documents/IUC5-85958e54-11c4-43b8-9167-b49890a247d0_e4f3614d-86a9-4056-a744-43798837d74c.html,,,,,, Monoazo Orange Pigment,250640-08-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2bcce236-eff8-4c78-8a7e-581239961e69/documents/IUC5-85958e54-11c4-43b8-9167-b49890a247d0_e4f3614d-86a9-4056-a744-43798837d74c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Monoazo Orange Pigment,250640-08-5,"Acute oral toxicity: LD50 > 2000 mg/kg bw; Limit-Test, GLP, OECD Guideline Study, Safepharm Laboratories Ltd, 1235/003, 1998. The test substance is virtually nontoxic after a single oral administration. Acute dermal toxicity: LD50 > 2000 mg/kg bw; Limit-Test, GLP, OECD Guideline Study, Safepharm Laboratories Ltd, 1235/054, 1998The test substance is virtually nontoxic after a single dermal application. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bcce236-eff8-4c78-8a7e-581239961e69/documents/IUC5-1d5ca24d-619b-4ca4-9fbd-37c63486a110_e4f3614d-86a9-4056-a744-43798837d74c.html,,,,,, Monoazo Orange Pigment,250640-08-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bcce236-eff8-4c78-8a7e-581239961e69/documents/IUC5-1d5ca24d-619b-4ca4-9fbd-37c63486a110_e4f3614d-86a9-4056-a744-43798837d74c.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Monoazo Orange Pigment,250640-08-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bcce236-eff8-4c78-8a7e-581239961e69/documents/IUC5-1d5ca24d-619b-4ca4-9fbd-37c63486a110_e4f3614d-86a9-4056-a744-43798837d74c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4-methoxyphenyl-4(5,6-epoxyhexyloxy)benzoate",144447-11-0,The oral LD50 value of the substance in Wistar rats was established to exceed 2000 mg/kg body weight. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/453deba2-c8d8-4999-9bbb-767629c292e2/documents/IUC5-dbdfc143-17a0-4ac5-94db-61f05b938616_8f6bc570-e404-47f5-b33b-da9e3855ad1e.html,,,,,, "2-methyl-1,4-phenylene bis(4-hydroxybenzoate)",119959-84-1,"oral: LD50 rat > 2000 mg/kg bw (BASF, 2000) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/106c04f6-afd6-4734-9c73-716009f049dd/documents/IUC5-79c1daff-99f1-4b06-800c-f199826a3b3a_e80e8d22-3f19-48ee-a566-882c02a4d722.html,,,,,, "2-methyl-1,4-phenylene bis(4-hydroxybenzoate)",119959-84-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/106c04f6-afd6-4734-9c73-716009f049dd/documents/IUC5-79c1daff-99f1-4b06-800c-f199826a3b3a_e80e8d22-3f19-48ee-a566-882c02a4d722.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzoic acid, 4-hydroxy- ester with alcohols C18-22-alkyl (even numbered)",201305-16-0,"NOAEL oral (subchronic), rat ≥ 1200 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcb3f2fb-5956-4f02-a587-5d4bd9e36dfa/documents/IUC5-5d5e3adb-4b74-4bf0-960a-46fa95b1d6fb_a56f53ac-be36-472f-8d4f-7dd4f787c713.html,,,,,, "Benzoic acid, 4-hydroxy- ester with alcohols C18-22-alkyl (even numbered)",201305-16-0,LD50 oral: > 2000 mg/kg bwLD50 dermal: > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcb3f2fb-5956-4f02-a587-5d4bd9e36dfa/documents/IUC5-f4cf04d5-cdeb-407c-a014-bc98aac8c857_a56f53ac-be36-472f-8d4f-7dd4f787c713.html,,,,,, "Benzoic acid, 5-[(4-aminophenyl)azo]-2-hydroxy-, reaction products with 3-[(4-amino-3-methoxyphenyl)azo]benzenesulfonic acid and carbonic dichloride, sodium salts",8005-52-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): 2 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b23da60e-00e7-4c8e-9755-06f2a6a63485/documents/f26485e3-5632-4b1a-af95-cea4baaa1fa9_87458ee5-f27c-4d54-b0e3-68a130deb8ac.html,,,,,, "Benzoic acid, 5-[(4-aminophenyl)azo]-2-hydroxy-, reaction products with 3-[(4-amino-3-methoxyphenyl)azo]benzenesulfonic acid and carbonic dichloride, sodium salts",8005-52-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b23da60e-00e7-4c8e-9755-06f2a6a63485/documents/f26485e3-5632-4b1a-af95-cea4baaa1fa9_87458ee5-f27c-4d54-b0e3-68a130deb8ac.html,,oral,LD50,"15,270 mg/kg bw",no adverse effect observed, "Benzoic acid, 5-[(4-aminophenyl)azo]-2-hydroxy-, reaction products with 3-[(4-amino-3-methoxyphenyl)azo]benzenesulfonic acid and carbonic dichloride, sodium salts",8005-52-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b23da60e-00e7-4c8e-9755-06f2a6a63485/documents/f26485e3-5632-4b1a-af95-cea4baaa1fa9_87458ee5-f27c-4d54-b0e3-68a130deb8ac.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "5-methyl-2-(2H-1,2,3-triazol-2-yl)benzoic acid",956317-36-5," The LD50 was greater than 2000 mg/kg bw in rats. Accordingly, the test item was considered to be in Acute Toxic Category 5 (unclassified). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fa70a50-1328-41cd-90b5-8da27577f996/documents/963efe36-d7a9-4534-9ebf-3713aa61a050_7dafb183-1a2b-4226-aaed-faaa4f69a5ca.html,,,,,, "5-methyl-2-(2H-1,2,3-triazol-2-yl)benzoic acid",956317-36-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fa70a50-1328-41cd-90b5-8da27577f996/documents/963efe36-d7a9-4534-9ebf-3713aa61a050_7dafb183-1a2b-4226-aaed-faaa4f69a5ca.html,,oral,discriminating dose,"2,000 mg/kg bw",, "Benzoic acid, C9-11, C10-rich, branched alkyl esters",131298-44-7,"This study was conducted in compliance with the United States Environmental Protection Agency (EPA) TSCA Good Laboratory Practice Standards (40 CFR Part 792), 18 September 1989; the Organisation for Economic Cooperation and Development (OECD) Principles of Good Laboratory Practice [C (97) 186/Final]. The protocol was designed to be in general accordance with the OECD Guidelines for Testing Chemicals, Health Effects Test Guidelines, Section 408, September 1998, and the European Chemicals Bureau test method B.26 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c89d4ba-509e-4886-b9f2-5202c06c8a2c/documents/IUC5-6ed2aaef-40fd-40b4-9b20-3220d3c259a9_3e8da908-7fae-45f9-b7bf-5cd1f5e88e5a.html,,,,,, "Benzoic acid, C9-11, C10-rich, branched alkyl esters",131298-44-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c89d4ba-509e-4886-b9f2-5202c06c8a2c/documents/IUC5-6ed2aaef-40fd-40b4-9b20-3220d3c259a9_3e8da908-7fae-45f9-b7bf-5cd1f5e88e5a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,619 mg/kg bw/day,,rat "2,3-Dichlorbenzonitril",6574-97-6," In order to evalute the acute oral toxic potential of 2,3 -Dichlorobenzonitrile a study according to OECD 425 and OPPTS 871 .1100 was performed. Under the conditions of the present study the estimated LD50 of the test item 2,3-Dichlorobenzonitrile in rats is 550 mg/kg bw. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc7509bb-28cb-4abd-a2c8-24d1ff42806f/documents/6bd6bf1e-5140-46b9-bf74-9bf2a6e0607b_ccdcd084-f5a2-4756-9551-2ce8c3151807.html,,,,,, "2,3-Dichlorbenzonitril",6574-97-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc7509bb-28cb-4abd-a2c8-24d1ff42806f/documents/6bd6bf1e-5140-46b9-bf74-9bf2a6e0607b_ccdcd084-f5a2-4756-9551-2ce8c3151807.html,,oral,LD50,550 mg/kg bw,adverse effect observed, "3,3'-(3,6-dioxo-2,3,5,6-tetrahydropyrrolo[3,4-c]pyrrole-1,4-diyl)dibenzonitrile",84632-50-8,"The test item was administered orally by gavage to groups of 10 male and 10 female Sprague-Dawley rats at dose levels of 0 mg/kg body weight/day (vehicle CMC), 15 mg/kg bw/d, 150 mg/kg bw/d and 1000 mg/kg bw/d for 28 days (OECD guideline 407, EU method B.7, GLP conditions). Clinical examinations, clinical pathology, histopathology and gross pathology did not reveal any finding in treated animals. The no observed adverse effect level (NOAEL) for general systemic toxicity was 1000 mg/kg bw/d in both sexes. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7bbf73da-1efc-4692-9d52-a2274c57032c/documents/IUC5-fd95900f-e07a-4c97-956a-d5a42da3c4d6_10393fdc-c3a3-4219-859e-5e265bfdce0b.html,,,,,, "3,3'-(3,6-dioxo-2,3,5,6-tetrahydropyrrolo[3,4-c]pyrrole-1,4-diyl)dibenzonitrile",84632-50-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7bbf73da-1efc-4692-9d52-a2274c57032c/documents/IUC5-fd95900f-e07a-4c97-956a-d5a42da3c4d6_10393fdc-c3a3-4219-859e-5e265bfdce0b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,3'-(3,6-dioxo-2,3,5,6-tetrahydropyrrolo[3,4-c]pyrrole-1,4-diyl)dibenzonitrile",84632-50-8,"A single dose of the test item was administered orally or dermally to Wistar rats at concentrations of 5000 and 2000 mg/kg bw, respectively. No mortality occurred. Clinical examiniation and gross necropsy did not reveal any findings. The LD50 after oral administration is therefore considered to be > 5000 mg/kg bw and after dermal application > 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bbf73da-1efc-4692-9d52-a2274c57032c/documents/IUC5-a831693a-0df7-40a2-aca6-5bcf30b5668f_10393fdc-c3a3-4219-859e-5e265bfdce0b.html,,,,,, "3,3'-(3,6-dioxo-2,3,5,6-tetrahydropyrrolo[3,4-c]pyrrole-1,4-diyl)dibenzonitrile",84632-50-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bbf73da-1efc-4692-9d52-a2274c57032c/documents/IUC5-a831693a-0df7-40a2-aca6-5bcf30b5668f_10393fdc-c3a3-4219-859e-5e265bfdce0b.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "3,3'-(3,6-dioxo-2,3,5,6-tetrahydropyrrolo[3,4-c]pyrrole-1,4-diyl)dibenzonitrile",84632-50-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bbf73da-1efc-4692-9d52-a2274c57032c/documents/IUC5-a831693a-0df7-40a2-aca6-5bcf30b5668f_10393fdc-c3a3-4219-859e-5e265bfdce0b.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4-[(4,6-dihydroxypyrimidin-2-yl)amino]benzonitrile",374067-80-8," Repeated dose toxicity - oral: In a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the test substance was administered daily to rats up to a dose level of 1000 mg/kg body weight/day (OECD 422; Van Otterdijk, 2016). The NOAEL is established as at least 1000 mg/kg body weight/day. The substance is therefore not classified as STOT RE, according to CLP Regulation. Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According tothe REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/312c683c-4188-4033-aba6-5dba63567235/documents/0714a716-32e7-4feb-9a61-6f01546471f7_b6c4e46f-617c-49d4-86ad-cc46b95ead58.html,,,,,, "4-[(4,6-dihydroxypyrimidin-2-yl)amino]benzonitrile",374067-80-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/312c683c-4188-4033-aba6-5dba63567235/documents/0714a716-32e7-4feb-9a61-6f01546471f7_b6c4e46f-617c-49d4-86ad-cc46b95ead58.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "4-[(4,6-dihydroxypyrimidin-2-yl)amino]benzonitrile",374067-80-8," Acute toxicity: Oral Under the described conditions of the study performed according to OECD Guideline 423, the acute oral median lethal dose (LD50) of the test substance in the female outbred albino mouse was estimated to be greater than 2000 mg/kg bw (Sanders, 2004). Acute toxicity: Inhalation No acute toxicity study via the inhalation route was available. However, this endpoint is waived as specific data are available for the oral and dermal exposure routes. Acute toxicity: Dermal In an acute dermal toxicity study in male and female Crl:WI (Han) (SPF) rats, following the standard acute method according to OECD Guideline 402 and EC method B.3, the LD50 was established to exceed 2000 mg/kg body weight (Latour, 2016). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/312c683c-4188-4033-aba6-5dba63567235/documents/IUC5-ddd3d6bd-e581-49ab-aabb-8593b2f097fd_b6c4e46f-617c-49d4-86ad-cc46b95ead58.html,,,,,, "4-[(4,6-dihydroxypyrimidin-2-yl)amino]benzonitrile",374067-80-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/312c683c-4188-4033-aba6-5dba63567235/documents/IUC5-ddd3d6bd-e581-49ab-aabb-8593b2f097fd_b6c4e46f-617c-49d4-86ad-cc46b95ead58.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "4-[(4,6-dihydroxypyrimidin-2-yl)amino]benzonitrile",374067-80-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/312c683c-4188-4033-aba6-5dba63567235/documents/IUC5-ddd3d6bd-e581-49ab-aabb-8593b2f097fd_b6c4e46f-617c-49d4-86ad-cc46b95ead58.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-[(4-CHLOROPYRIMIDIN-2-YL)AMINO]BENZONITRILE,244768-32-9," Repeated dose toxicity - oral: In a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the test substance was administered daily to rats up to a dose level of 1000 mg/kg body weight/day (OECD 422; van Otterdijk, 2017). The NOAEL is established to be at least 1000 mg/kg. Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/604519bd-04f0-403a-91df-2bd57964b816/documents/1dd9a90b-7930-420f-a273-c2b86b75f7b8_5b696afd-f20c-4ea1-ab17-d3c8eb8d093b.html,,,,,, 4-[(4-CHLOROPYRIMIDIN-2-YL)AMINO]BENZONITRILE,244768-32-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/604519bd-04f0-403a-91df-2bd57964b816/documents/1dd9a90b-7930-420f-a273-c2b86b75f7b8_5b696afd-f20c-4ea1-ab17-d3c8eb8d093b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 4-[(4-CHLOROPYRIMIDIN-2-YL)AMINO]BENZONITRILE,244768-32-9," Acute toxicity: Oral The acute oral toxicity was assessed with a K2 acute toxic class method performed following the OECD Guideline 423 (Sanders, 2004). The LD50 was determined to be greater than 2000 mg/kg bw. Acute toxicity: Inhalation In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For T002488, a key study is available for the dermal route of exposure. Therefore, an acute inhalation toxicity study should not be performed. Acute toxicity: Dermal In an acute dermal toxicity study in male and female Crl:WI (Han) (SPF) rats, following the standard acute method according to OECD Guideline 402 and EC method B.3, the LD50 was established to exceed 2000 mg/kg body weight (Latour, 2016). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/604519bd-04f0-403a-91df-2bd57964b816/documents/IUC5-90a1d08d-299c-4eba-8c96-9fa53f438e20_5b696afd-f20c-4ea1-ab17-d3c8eb8d093b.html,,,,,, 4-[(4-CHLOROPYRIMIDIN-2-YL)AMINO]BENZONITRILE,244768-32-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/604519bd-04f0-403a-91df-2bd57964b816/documents/IUC5-90a1d08d-299c-4eba-8c96-9fa53f438e20_5b696afd-f20c-4ea1-ab17-d3c8eb8d093b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-[(4-CHLOROPYRIMIDIN-2-YL)AMINO]BENZONITRILE,244768-32-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/604519bd-04f0-403a-91df-2bd57964b816/documents/IUC5-90a1d08d-299c-4eba-8c96-9fa53f438e20_5b696afd-f20c-4ea1-ab17-d3c8eb8d093b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Benzophenone-3,3':4,4'-tetracarboxylic dianhydride",2421-28-5," Adverse test item-related effects were noted at 1000 mg BTDA/kg b.w./day in form of a reduced body weight in females, an increased food and drinking water consumption, and a decreased hindlimb grip strength compared to the control group. The experimental no-observed-adverse-effect level (NOAEL) was 300 mg 3,3 ',4,4' -benzophenonetetracarboxylic dianhydride (BTDA)/kg b. w. by daily oral administration for 91 days. For systemic effects following administration via inhalation, the LOAEC is above 136 mg/m3 as dust. For local effects, the NOAEC is 55 mg/m3 as dust. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00a7a9a9-56f2-44f5-9adf-d34020b1d9f2/documents/IUC5-3e58a43b-1913-4862-b20c-5fe8d12b3032_8955aa24-bf2a-4a12-8c0a-7a88c826f4ea.html,,,,,, "Benzophenone-3,3':4,4'-tetracarboxylic dianhydride",2421-28-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00a7a9a9-56f2-44f5-9adf-d34020b1d9f2/documents/IUC5-3e58a43b-1913-4862-b20c-5fe8d12b3032_8955aa24-bf2a-4a12-8c0a-7a88c826f4ea.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,135 mg/m3,,guinea pig "Benzophenone-3,3':4,4'-tetracarboxylic dianhydride",2421-28-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00a7a9a9-56f2-44f5-9adf-d34020b1d9f2/documents/IUC5-3e58a43b-1913-4862-b20c-5fe8d12b3032_8955aa24-bf2a-4a12-8c0a-7a88c826f4ea.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Benzophenone-3,3':4,4'-tetracarboxylic dianhydride",2421-28-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00a7a9a9-56f2-44f5-9adf-d34020b1d9f2/documents/IUC5-3e58a43b-1913-4862-b20c-5fe8d12b3032_8955aa24-bf2a-4a12-8c0a-7a88c826f4ea.html,Repeated dose toxicity – local effects,inhalation,NOAEC,55 mg/m3,adverse effect observed,guinea pig "Benzophenone-3,3':4,4'-tetracarboxylic dianhydride",2421-28-5,"The acute oral LD50 for BTDA is 12,800 mg/kg bw in rats. The acute dermal toxicity for BTDA is > 3160 mg/kg bw in rabbits. The acute inhalation LC50for BTDA is > 4.44 mg/l (1400 ppm) in rats, mice and guinea pigs after a single dose, and is 3.0 mg/l in guinea pigs after a 5-day exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00a7a9a9-56f2-44f5-9adf-d34020b1d9f2/documents/IUC5-9a23fa98-2f83-4fd1-9a69-92ae5b15617a_8955aa24-bf2a-4a12-8c0a-7a88c826f4ea.html,,,,,, "Benzophenone-3,3':4,4'-tetracarboxylic dianhydride",2421-28-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00a7a9a9-56f2-44f5-9adf-d34020b1d9f2/documents/IUC5-9a23fa98-2f83-4fd1-9a69-92ae5b15617a_8955aa24-bf2a-4a12-8c0a-7a88c826f4ea.html,,oral,LD50,"12,800 mg/kg bw",no adverse effect observed, "Benzophenone-3,3':4,4'-tetracarboxylic dianhydride",2421-28-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00a7a9a9-56f2-44f5-9adf-d34020b1d9f2/documents/IUC5-9a23fa98-2f83-4fd1-9a69-92ae5b15617a_8955aa24-bf2a-4a12-8c0a-7a88c826f4ea.html,,dermal,LD50,"3,160 mg/kg bw",no adverse effect observed, "Benzophenone-3,3':4,4'-tetracarboxylic dianhydride",2421-28-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00a7a9a9-56f2-44f5-9adf-d34020b1d9f2/documents/IUC5-9a23fa98-2f83-4fd1-9a69-92ae5b15617a_8955aa24-bf2a-4a12-8c0a-7a88c826f4ea.html,,inhalation,LC50,"4,440 mg/m3",no adverse effect observed, Benzothiazole-2-thiol,149-30-4,Mercaptobezothiazole LOAEL = 750 mg/kg-day (based on decreased body weight gain in females) NOAEL = 375 mg/kg-day in 13 weeks study. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af3fd1b0-625d-4cde-bb63-c842b6171bdc/documents/IUC5-737688c0-bff8-41f2-ba9d-b2b8113baaea_763c68e4-b6bc-47e6-aa53-b48ea0773993.html,,,,,, Benzothiazole-2-thiol,149-30-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af3fd1b0-625d-4cde-bb63-c842b6171bdc/documents/IUC5-737688c0-bff8-41f2-ba9d-b2b8113baaea_763c68e4-b6bc-47e6-aa53-b48ea0773993.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,375 mg/kg bw/day,,rat Benzothiazole-2-thiol,149-30-4,The oral LD50 was 3800 mg/kg (95% confidence limits 3530-4100 mg/kg). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af3fd1b0-625d-4cde-bb63-c842b6171bdc/documents/IUC5-b18160bf-ee48-49c7-9ca4-26f2a37f89c9_763c68e4-b6bc-47e6-aa53-b48ea0773993.html,,,,,, Benzothiazole-2-thiol,149-30-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af3fd1b0-625d-4cde-bb63-c842b6171bdc/documents/IUC5-b18160bf-ee48-49c7-9ca4-26f2a37f89c9_763c68e4-b6bc-47e6-aa53-b48ea0773993.html,,oral,LD50,"3,800 mg/kg bw",, Benzotriazole-1-yl-oxy-tris-pyrrolidino-phosphonium hexafluorophosphate,128625-52-5, The LD50 value was determined to be between 300 and 2000 mg/kg after single oral administration in female rats (reference 7.2.1 -1). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48e8697a-1f64-4881-a762-baa5e88ecd76/documents/bdb79223-3405-491d-b7ba-6c343e110012_d1a82767-83e1-4066-9114-5753987fc362.html,,,,,, Benzotriazole-1-yl-oxy-tris-pyrrolidino-phosphonium hexafluorophosphate,128625-52-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48e8697a-1f64-4881-a762-baa5e88ecd76/documents/bdb79223-3405-491d-b7ba-6c343e110012_d1a82767-83e1-4066-9114-5753987fc362.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "benzovindiflupyr (ISO); N-[9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide",1072957-71-1,"NO(A)EL (oral, dietary, 2-year, rat) at 100 ppm (males: 4.88 mg/kg bw/day, females: 6.66 mg/kg bw/day; see IUCLID section 7.7, Carcinogenicity)NO(A)EL (dermal, 28-day, rat) at 1000 mg/kg bw/day ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ad06431-de0d-4801-be59-655a6e5be697/documents/IUC5-3bf5ed02-0322-4044-9e38-92d1061400ad_3adfbab4-8b74-4384-8a55-5c87155e360c.html,,,,,, "benzovindiflupyr (ISO); N-[9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide",1072957-71-1,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ad06431-de0d-4801-be59-655a6e5be697/documents/IUC5-3bf5ed02-0322-4044-9e38-92d1061400ad_3adfbab4-8b74-4384-8a55-5c87155e360c.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "benzovindiflupyr (ISO); N-[9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide",1072957-71-1,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ad06431-de0d-4801-be59-655a6e5be697/documents/IUC5-3bf5ed02-0322-4044-9e38-92d1061400ad_3adfbab4-8b74-4384-8a55-5c87155e360c.html,Chronic toxicity – systemic effects,oral,NOAEL,4.88 mg/kg bw/day,,rat "benzovindiflupyr (ISO); N-[9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide",1072957-71-1,Acute oral MLD = 55 mg/kg (rat); dermal MLD = >2000 mg/kg (rat) and acute inhalation MLC = 0.56 mg/l (rat). ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ad06431-de0d-4801-be59-655a6e5be697/documents/IUC5-143ac24d-8aa1-4a43-93d3-76a7d0b182a5_3adfbab4-8b74-4384-8a55-5c87155e360c.html,,,,,, "benzovindiflupyr (ISO); N-[9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide",1072957-71-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ad06431-de0d-4801-be59-655a6e5be697/documents/IUC5-143ac24d-8aa1-4a43-93d3-76a7d0b182a5_3adfbab4-8b74-4384-8a55-5c87155e360c.html,,oral,LD50,55 mg/kg bw,, "benzovindiflupyr (ISO); N-[9-(dichloromethylene)-1,2,3,4-tetrahydro-1,4-methanonaphthalen-5-yl]-3-(difluoromethyl)-1-methyl-1H-pyrazole-4-carboxamide",1072957-71-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ad06431-de0d-4801-be59-655a6e5be697/documents/IUC5-143ac24d-8aa1-4a43-93d3-76a7d0b182a5_3adfbab4-8b74-4384-8a55-5c87155e360c.html,,inhalation,LC50,560 mg/m3,, "(7R)-4-(5-Chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-ium chloride",1266664-66-7," The LD50 was greater than 300 mg/kg bw, but less than 2000 mg/kg bw in rats. Accordingly, the test item was considered to be in Acute Toxic Category 4. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b86d502e-67fa-4a72-a848-9e3a6a618d44/documents/6c077694-9b71-48b9-9b3e-f8b1f8b55d38_092c1740-ef21-4a34-8c24-68709c2d94bc.html,,,,,, "(7R)-4-(5-Chloro-1,3-benzoxazol-2-yl)-7-methyl-1,4-diazepan-1-ium chloride",1266664-66-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b86d502e-67fa-4a72-a848-9e3a6a618d44/documents/6c077694-9b71-48b9-9b3e-f8b1f8b55d38_092c1740-ef21-4a34-8c24-68709c2d94bc.html,,oral,LD50,300 mg/kg bw,, "rac-3-(2,3-Diacetoxypropylcarbamoyl)-2,4,6-triiodo-5-methoxyacetylaminobenzoyl chloride",150928-21-5,"Oral (Rat-Wistar, GLP, non-audited report, OECD TG 423): LD50 > 2000 mg/kg [Schering AG, 1993-05-17]Dermal (Rat-Wistar, GLP, non-audited report, OECD TG 402 and 404): LD50 > 2000 mg/kg [Schering AG, 1994-05-25] Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Quality is high, guideline study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Quality high, guideline study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccdc836e-5760-4b52-a3f0-e8135e5b6e81/documents/d52e347c-dc49-48fb-b53c-006f5226eaaa_a63caeb3-a42e-4ade-a2c0-dec14279acc7.html,,,,,, "rac-3-(2,3-Diacetoxypropylcarbamoyl)-2,4,6-triiodo-5-methoxyacetylaminobenzoyl chloride",150928-21-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccdc836e-5760-4b52-a3f0-e8135e5b6e81/documents/d52e347c-dc49-48fb-b53c-006f5226eaaa_a63caeb3-a42e-4ade-a2c0-dec14279acc7.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "rac-3-(2,3-Diacetoxypropylcarbamoyl)-2,4,6-triiodo-5-methoxyacetylaminobenzoyl chloride",150928-21-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccdc836e-5760-4b52-a3f0-e8135e5b6e81/documents/d52e347c-dc49-48fb-b53c-006f5226eaaa_a63caeb3-a42e-4ade-a2c0-dec14279acc7.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 4-[(2-methoxybenzoyl)sulfamoyl]benzoyl chloride,816431-72-8,"Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg [Schuengel, 2006]   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4989941b-457e-4b20-902c-f6edd7900807/documents/3db0d0d2-3b1e-4b54-bbb6-58990d187579_dbaa5a45-9766-4240-9df3-45dc69762ba9.html,,,,,, 4-[(2-methoxybenzoyl)sulfamoyl]benzoyl chloride,816431-72-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4989941b-457e-4b20-902c-f6edd7900807/documents/3db0d0d2-3b1e-4b54-bbb6-58990d187579_dbaa5a45-9766-4240-9df3-45dc69762ba9.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Benzyl 4-[(1-butyl-5-cyano-1,6-dihydro-2-hydroxy-4-methyl-6-oxopyridin-3-yl)azo]benzoate",75199-13-2," LD50 (oral, rats) > 5000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fede188b-14be-4e1e-ba24-ca8d05e23de3/documents/324fdbc3-270f-49bf-93b2-58e22d635666_419ec0e5-5261-438a-ab79-cdf316013131.html,,,,,, Benzyl acrylate,2495-35-4,"OECD 422 Combined Repeated Dose Toxicity Study and Reproductive/Developmental Toxicity Screening Study Test in Rats. The purpose of this study was the assessment of general systemic toxic potential in rats, including a screen for reproductive/developmental effects and assessment of endocrine disruptor relevant endpoints, with administration of BZA (Benzyl acrylate) by oral gavage administration for at least 4 weeks. Assessment of toxicity was based on mortality, clinical observations, neurobehavioral evaluation, body weights, food consumption, and necropsy findings. Blood samples were collected for clinical pathology evaluation. Once-daily oral gavage administration of 60, 200, or 600 mg/kg/day BZA to male rats for 35 consecutive days and female rats for up to 61 days (pre-pairing, throughout gestation, and during the first 2 weeks of lactation) was well tolerated, with no BZA-related mortality or clinical observations. No BZA-related alterations in body weight or food consumption were noted for F0 animals at any dose examined. BZA-related, nonadverse clinical chemistry effects included minimally higher triglycerides concentration in males administered 600 mg/kg/day and minimally higher globulin, resulting in lower albumin:globulin ratio in females administered ≥200 mg/kg/day. No BZA-related effects on F0 male T4 levels were noted. A BZA-related, nonadverse microscopic finding of minimal adrenal cortical hypertrophy was noted in F0 males administered ≥60 mg/kg/day, which correlated with increased adrenal weights. In addition, a BZA-related, nonadverse microscopic finding of minimally decreased cortical lymphocytes of the thymus was noted in F0 males and females administered 600 mg/kg/day, which correlated with decreased thymus weights in those same dose groups. Based on these findings, the no-observed-adverse-effect level (NOAEL) for F0 males and females was 600 mg/kg/day.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c679a5e9-848c-4384-8882-4e010b65cd5e/documents/111f8a13-b2b3-476b-a4ca-a26995653b4e_17f7bc3f-e6de-48c4-b61f-19132aae79c6.html,,,,,, Benzyl acrylate,2495-35-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c679a5e9-848c-4384-8882-4e010b65cd5e/documents/111f8a13-b2b3-476b-a4ca-a26995653b4e_17f7bc3f-e6de-48c4-b61f-19132aae79c6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat Benzyl acrylate,2495-35-4,"Acute toxicity, oral, (rat): LD50 > 2000 mg/kg bodyweight Acute toxicity, inhalation (rat): LD50  >4.17 mg/kg bodyweight ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c679a5e9-848c-4384-8882-4e010b65cd5e/documents/0d4035e4-d924-4fa7-a3b5-10d21d1b5a78_17f7bc3f-e6de-48c4-b61f-19132aae79c6.html,,,,,, Benzyl acrylate,2495-35-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c679a5e9-848c-4384-8882-4e010b65cd5e/documents/0d4035e4-d924-4fa7-a3b5-10d21d1b5a78_17f7bc3f-e6de-48c4-b61f-19132aae79c6.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Benzyl acrylate,2495-35-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c679a5e9-848c-4384-8882-4e010b65cd5e/documents/0d4035e4-d924-4fa7-a3b5-10d21d1b5a78_17f7bc3f-e6de-48c4-b61f-19132aae79c6.html,,inhalation,LC50,> 4.17 mg/m3,no adverse effect observed, Benzyl methacrylate,2495-37-6," In an OECD Guideline 422 and GLP study with Benzyl methacrylate, the NOAEL for repeated dose toxicity is determined to 500 mg/kg/day which was the highest dose tested. Moreover, there is sufficient information to confirm the absence of a critical potential by read across to data on structurally related substances and the relevant metabolites methacrylic acid, benzyl alcohol and benzoic acid. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8001f783-8105-41b2-b5b2-dd3cfd4fabe2/documents/IUC5-ba724369-29a0-4696-af82-e37f28e17e1c_ceab3e53-1743-4c67-8ed3-31aa1a0da1b9.html,,,,,, Benzyl methacrylate,2495-37-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8001f783-8105-41b2-b5b2-dd3cfd4fabe2/documents/IUC5-ba724369-29a0-4696-af82-e37f28e17e1c_ceab3e53-1743-4c67-8ed3-31aa1a0da1b9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Benzyl methacrylate,2495-37-6,"Acute oral toxicity: LD50 (rat, females) = 3980 mg/kg bw; OECD Guideline 401; GLPAcute inhalation toxicity: no relevant route of exposureAcute dermal toxicity: LD50 (rat, male/female) > 2000 mg/kg bw; OECD Guideline 402; GLP ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8001f783-8105-41b2-b5b2-dd3cfd4fabe2/documents/IUC5-7df7a031-e1b8-4093-89a0-30395d60eb81_ceab3e53-1743-4c67-8ed3-31aa1a0da1b9.html,,,,,, Benzyl methacrylate,2495-37-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8001f783-8105-41b2-b5b2-dd3cfd4fabe2/documents/IUC5-7df7a031-e1b8-4093-89a0-30395d60eb81_ceab3e53-1743-4c67-8ed3-31aa1a0da1b9.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, Benzyl methacrylate,2495-37-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8001f783-8105-41b2-b5b2-dd3cfd4fabe2/documents/IUC5-7df7a031-e1b8-4093-89a0-30395d60eb81_ceab3e53-1743-4c67-8ed3-31aa1a0da1b9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "benzyl(diethylamino)diphenylphosphonium 4-[1,1,1,3,3,3-hexafluoro-2-(4-hydroxyphenyl)propan-2-yl]phenolate",577705-90-9,"An oral toxicity study and a dermal toxicity study according to OECD GLP in the testing of chemicals [C(81)30 final], regulation enforced by the Italian Health Authority (D.M. dated June 26, 1986 as published in G.U. no.198, August 27, 1986 and D.M.dated April 28, 1988 as published in G.U. no.107, May 9, 1988 were performed to test the acute toxicity of the substance.The studies were guidelines conform and performed under GLP conditions.Basing on the results of the studies, REGULATION (EC) No 1272/2008 on Classification, Labelling and Packaging of substance would indicate the following: Classification Acute oral toxicity: toxic Category 4 Classification Acute dermal toxicity: Not required ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb97b0af-cead-4d10-b03f-198d09a1632c/documents/IUC5-d79f7e80-572f-4ad1-8500-c0d98c5e44bb_6323d082-2984-48c6-ab00-cc6082303465.html,,,,,, Benzyldimethylamine,103-83-3,"Subacute studies: Rats NOAEL (gavage) = 150 mg/kg bw/day (basis: highest dose level tested) (BG Chemie, 1998, Key, Rel.1) Rats NOEL (gavage) = 50 mg/kg bw/day (basis: miosis at 100 mg/kg bw/day in both sexes) (MHLW, 1997, K, rel.2) Sub-chronic study: Rats NOAEL (gavage) = 75 mg/kg bw/day (basis: mortality and generalized tremors at 150 mg/kg bw/day) (Charles River Laboratories, 2023, Key, Rel.1) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/383d15c1-3ed8-47df-9bdf-a70242f182f2/documents/IUC5-a0846e4b-acb5-4ac7-938b-e86184020168_af4cb78e-5cd9-408f-81a9-c2df256c6c32.html,,,,,, Benzyldimethylamine,103-83-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/383d15c1-3ed8-47df-9bdf-a70242f182f2/documents/IUC5-a0846e4b-acb5-4ac7-938b-e86184020168_af4cb78e-5cd9-408f-81a9-c2df256c6c32.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat Benzyldimethylamine,103-83-3,Different doses of undiluted test substance given per gavage to male rats resulted in LD50 oral: 0.65 ml (579 mg/kg bw);Different doses applied to the dorsal skin of male rabbits resulted in LD50 dermal: 1.66 ml/kg (1477 mg/kg bw);Whole body exposure of male and femle rats to different vapour concentrations for 4 hours resulted in LC50 inhal: 373 ppm (2052 mg/m³). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/383d15c1-3ed8-47df-9bdf-a70242f182f2/documents/IUC5-b2d077a4-933f-4649-b4ff-2615e0d6b545_af4cb78e-5cd9-408f-81a9-c2df256c6c32.html,,,,,, Benzyldimethylamine,103-83-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/383d15c1-3ed8-47df-9bdf-a70242f182f2/documents/IUC5-b2d077a4-933f-4649-b4ff-2615e0d6b545_af4cb78e-5cd9-408f-81a9-c2df256c6c32.html,,oral,LD50,579 mg/kg bw,adverse effect observed, Benzyldimethylamine,103-83-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/383d15c1-3ed8-47df-9bdf-a70242f182f2/documents/IUC5-b2d077a4-933f-4649-b4ff-2615e0d6b545_af4cb78e-5cd9-408f-81a9-c2df256c6c32.html,,dermal,LD50,"1,477 mg/kg bw",adverse effect observed, Benzyldimethylamine,103-83-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/383d15c1-3ed8-47df-9bdf-a70242f182f2/documents/IUC5-b2d077a4-933f-4649-b4ff-2615e0d6b545_af4cb78e-5cd9-408f-81a9-c2df256c6c32.html,,inhalation,LC50,"2,052 mg/m3",adverse effect observed, Benzylmagnesium chloride,6921-34-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74984fb0-45d7-469d-9665-18825e3f9579/documents/IUC5-f4c03d98-821e-4505-9a94-4b5b66a38ccb_30813da9-cdb6-405a-b1d4-8048a90d07a7.html,,inhalation,discriminating conc.,"1,500 mg/m3",no adverse effect observed, Benzyltoluene,27776-01-8,"Two key studies are available for oral repeated dose toxicity of benzyl toluene.   The first one (Verschuere, 1992) is a 4-month study that was conducted on rats using benzyl toluene of very high purity. The study was conducted according to OECD 408 guideline, with minor deviations (120 days exposure duration, ophthalmologic examination and neurobiological examination not performed) and was GLP. Benzyl toluene was administered by gavage as suspension in 10% arabic gum at the dose-levels of 0, 5, 50 and 500 mg/kg bw to four groups of 20 Sprague-Dawley rats (10 rats/sex/group). The clinical signs were observed twice a day, the body-weight and the food consumption were recorded once a week. For all animals, ophthalmology, clinical pathology, hematology investigations and urine analysis were performed after at least 120 days of treatment. After at least 120 days of treatment, the rats were sacrificed and a full macroscopic examination was performed, selected organs weighted, and certain organs submitted to histological examination. No behavioral changes were noted. Ophthalmoscopic examinations did not show any treatment-related lesions. The growth rate of high-dose (500 mg/kg bw) animals was slightly lower than that of controls throughout the study. This difference was not statistically significant. Food consumption was unaffected by the treatment. Hematological examinations showed tendency towards anemia in female rats treated at 500 mg/kg bw. No effect was observed in males, and in females of the 5 and 50 mg/kg bw groups. Blood biochemical examinations and urine analysis did not show any significant modifications. The study of organ weights showed an increase in the relative liver weight in high-dose males (+35%) and female (+41%), an increase in the relative kidney weight in high-dose males (+17%). Light microscopic examination revealed that the administration of benzyl toluene induced in the 500 mg/kg bw group an increased accumulation of hyaline globules in the renal proximal tubular cells in male animals, and a minimal hypertrophy of hepatocytes in male and female rats. On the basis of these results, the no-effect level for benzyl toluene administrated to rat during a 120 day period can be estimated at 50 mg/kg bw.   The other key study (Korn, 1990) had similar conclusion with same NOAEL and LOAEL. The potential toxicity of benzyl toluene was evaluated following repeated oral administration for 13 weeks, according to OECD Guideline 408. Benzyl toluene was administered once daily by gavage to Sprague-Dawley rats (10 Males and 10 Females), at the dose-levels of 0, 5, 50 and 500 mg/kg/d during 90 days. Body weights were recorded pre-test, weekly and at death or prior necropsy. Animals were observed daily for toxicity and pharmacological effects, and twice daily for morbidity and mortality. Food consumption was calculated weekly. A neurobehavioral examination was performed. Whole blood, serum and plasma were sampled just prior necropsy and analyzed for related hematological and clinical chemistry parameters. All animals were examined for gross pathology, and organs were weighted and submitted to histopathology. The No Observed Adverse Effect Level (NOAEL) for repeated dose toxicity was considered to be 50 mg/kg bw/d based on effects on liver weights and bilirubin level. All other findings in hematology, clinical chemistry and histopathology are considered to be coincidental and/or of no biological importance as they were completely reversible after a recovery period of 4 weeks.   There is also a 2 weeks oral toxicity study performed as preliminary study to the OECD 421 (CRL, 2021): in this study, the toxicity of the test item, Benzyltoluene, was evaluated after daily oral administration (gavage) to Sprague-Dawley rats at the dose levels of 100, 300, 600 and 800 mg/kg bw/day for 2 weeks.Based on the results of this study, the doses of 600 and 800 mg/kg bw/day were considered to exceed the Maximum Tolerated Dose (MTD) in males and females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d0f40f6-5fe0-4d6e-8581-eca9b01846d0/documents/IUC5-ff2c83c7-f33a-47f5-802b-1c940c637843_deeff2a4-5a82-49ef-996d-82f698bd7d09.html,,,,,, Benzyltoluene,27776-01-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d0f40f6-5fe0-4d6e-8581-eca9b01846d0/documents/IUC5-ff2c83c7-f33a-47f5-802b-1c940c637843_deeff2a4-5a82-49ef-996d-82f698bd7d09.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Benzyltoluene,27776-01-8," The data indicate that benzyl toluene is of low toxicity after single oral, dermal or inhalation exposures.   Acute oral toxicity Three studies are available for this endpoint: Petra, 1981 (key study) and Mürmann, 1984 and 1995 (supporting studies).   Benzyl toluene was administered as such at the dose level of 3.0 to 3.5 ml/kg in groups of 10 Sprague-Dawley rats (5 males and 5 females) (Petra, 1981). The mortality and general behavior of the animals were observed for a period of 14 days after the administration. The mortality rate was 10%, 60%, 70% and 100% at the dose levels of 3, 3.1, 3.2, 3.5 ml/kg, respectively. Prostration and sedation were observed after treatment. The bodyweight of the animals were not influenced by the treatment. Under these experimental conditions, the LD50 of benzyl toluene administered by oral route in the rat was 3015 mg/kg (2962-3068 mg/kg).   The Mürmann (1995) study was performed according to OECD guideline 401 and according to GLP. Initially 2000 mg/kg b.w. of benzyl toluene was administered orally to two male and female rats. Since no mortality was observed within 48 hours, 2000 mg/kg b.w. of benzyl toluene was administered to a further three male and three female animals. No deaths occurred during exposure or during the 14 days recovery period. Two animals showed symptoms (ataxia, staggering, abnormal gait). One female animal showed a low weight gain at day 14, all other animals showed normal changes in body weight.no gross organ lesions related to test substance were evident in all animals. At necropsy, no gross organ lesions related to test substance were evident in all animals. Under these experimental conditions, the LD0 of benzyl toluene by oral route is expected to be more than 2000 mg/kg bw.   The third one (Mürmann (1984) was also an OECD 401 guideline study but not GLP; its results are in line with those of the previous studies. The LD50 was 3100 mg/kg bw.   Acute inhalation toxicity The acute toxicity of benzyl toluene vapors generated at 70°C was tested in a group of 10 Sprague-Dawley rats (5 males and 5 females) (Delhomme and Traynard, 1983). Exposure duration were 4 hours and the maximum concentration reached was 1.88 mg/l. The mortality and general behavior of the animals were observed for a period of 14 days after the administration of the test substance. Under these experimental conditions, benzyl toluene did not induce any mortality, toxic effects and decrease of the body-weight gain.   Acute dermal toxicity: Two studies are available for this endpoint.   The acute dermal toxicity of benzyl toluene was determined in rabbits in a limit test performed according to recognized national procedure (no data on GLP) similar to OECD 402 procedure (Guillot, 1981). No mortality was observed at the dose-level of 2000 mg/kg. The general behavior and the bodyweight of the animals were not influenced by the treatment. Under these experimental conditions, the LD0 was higher than 2000 mg/kg. Only local signs of toxicity were recorded.   In the Kaufmann study (1990) (OECD 402, GLP), the acute dermal toxicity was tested in Wistar rats in a limit test (2000 mg/kg); no clinical signs of toxicity was observed -included local toxicity as irritation-; no death occurred. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d0f40f6-5fe0-4d6e-8581-eca9b01846d0/documents/IUC5-1cb1dded-3d53-4cdc-b605-a738ba6e3a9e_deeff2a4-5a82-49ef-996d-82f698bd7d09.html,,,,,, Benzyltoluene,27776-01-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d0f40f6-5fe0-4d6e-8581-eca9b01846d0/documents/IUC5-1cb1dded-3d53-4cdc-b605-a738ba6e3a9e_deeff2a4-5a82-49ef-996d-82f698bd7d09.html,,oral,LD50,"3,015 mg/kg bw",no adverse effect observed, Benzyltoluene,27776-01-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d0f40f6-5fe0-4d6e-8581-eca9b01846d0/documents/IUC5-1cb1dded-3d53-4cdc-b605-a738ba6e3a9e_deeff2a4-5a82-49ef-996d-82f698bd7d09.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, Benzyltoluene,27776-01-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d0f40f6-5fe0-4d6e-8581-eca9b01846d0/documents/IUC5-1cb1dded-3d53-4cdc-b605-a738ba6e3a9e_deeff2a4-5a82-49ef-996d-82f698bd7d09.html,,inhalation,LC0,"1,880 mg/m3",no adverse effect observed, Benzyltributylammonium 4-hydroxynaphthalene-1-sulfonate,102561-46-6,"Acute Toxicity Oral: LD50 >5000 mg/kg bw (male/female rat, standard acute method). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6fd9a3b-a150-4270-bff4-8e90f9f351e9/documents/IUC5-f0a45e0e-e2f7-4b56-9ad9-26bff0250835_5b58ba5e-0ae3-4db6-b337-8c24341d6ea8.html,,,,,, Benzyltributylammonium 4-hydroxynaphthalene-1-sulfonate,102561-46-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6fd9a3b-a150-4270-bff4-8e90f9f351e9/documents/IUC5-f0a45e0e-e2f7-4b56-9ad9-26bff0250835_5b58ba5e-0ae3-4db6-b337-8c24341d6ea8.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Benzyltrimethylammonium chloride,56-93-9,"The subchronic toxicity of benzyltrimethylammonium chloride was examined in F344 rats. In the 13 -week studies, groups of 10 male and 10 female rats received benzyltrimethylammonium chloride in deionized water by gavage at doses of 0, 12.5, 25, 50, or 100 mg/kg, 5 days per week for 13 weeks. Benzyltrimethylammonium chloride generally had little effect on the body weights of rats. Final mean body weights of dosed animals were within 8% (rats) of the control group body weights. The deaths of two female rats administered 100 mg/kg were the result of pharmacologic effects on the cardiovascular system. Some cholinergic effects including chromodacryorrhea, lacrimation, salivation, pupillary constriction, altered gait, and mild tremors were observed at nonlethal doses in rats; these effects were accompanied by alterations in body position. No significant target organ toxicity was observed in dosed rats. The subchronic toxicity of benzyltrimethylammonium chloride was examined in B6C3F1 mice. In the 13-week studies, groups of 10 male and 10 female mice received benzyltrimethylammonium chloride in deionized water by gavage at doses of 0, 12.5, 25, 50, or 100 mg/kg, 5 days per week for 13 weeks. Benzyltrimethylammonium chloride generally had little effect on the body weights of mice. Final mean body weights of dosed animals were within 3% (mice) of the control group body weights. The deaths of one male and one female mouse administered 100 mg/kg were the result of pharmacologic effects on the cardiovascular system. No significant target organ toxicity was observed in dosed mice.Based on the mortality observed in the 16-day and 13-week studies, rats and mice appeared to be equally sensitive to benzyltrimethylammonium chloride. The minimally toxic dose for rats and mice was estimated to be 50 mg/kg. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca9c35d7-1cc8-4711-85a6-3bf328457d32/documents/IUC5-15bf6653-a227-4473-8f78-0c14047606f0_b78a072d-8396-464d-8719-12c2f1aab5d5.html,,,,,, Benzyltrimethylammonium chloride,56-93-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca9c35d7-1cc8-4711-85a6-3bf328457d32/documents/IUC5-15bf6653-a227-4473-8f78-0c14047606f0_b78a072d-8396-464d-8719-12c2f1aab5d5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Benzyltrimethylammonium chloride,56-93-9,"The acute oral toxicity of benzyltrimethylammonium chloride was examined in rats and mice. All rats survived and gained weight following oral administration of 50 mg/kg. An old study reported a rat oral LD50 of 250 mg/kg but not further information was available. All mice dosed with benzyltrimethylammonium chloride died following an acute oral dose of 1600 mg/kg.Two groups of five rats/sex were exposed using a nose-only inhalation exposure system, to time-weighted average chamber concentration of 0.64 or 2.03 mg benzyltrimethylammonium chloride per liter of air. All animals died during exposure to 2.03 mg/L (100% mortality by 97 minutes of exposure. All animals survived the four-hour exposure to 0.64 mg/L as well as the two-week post-exposure observation period. Based on these data, the calculated four-hour LC50 of inhaled particulate benzyltrimethylammonium chloride is 1.14 mg/L for male and female F344/DuCrl rats.The dermal LD50 values of BTMAC-60% in rabbits were calculated to be 633 mg/kg body weight for the males, 410 mg/kg body weight for the females and 510 mg/kg body weight for the sexes combined. Due to the mortality distribution, no fiducial limits could be determined for the LD50 values for males and females.The dermal toxicity of the test material was examined at one dose level, 200 mg/kg. All rabbits dosed dermally with 200 mg/kg test material died. One rabbit survived for at least 24 hours post dosing, all others died within 24 hours. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca9c35d7-1cc8-4711-85a6-3bf328457d32/documents/IUC5-edd3271c-c42d-4123-a432-23e0cb9cefa2_b78a072d-8396-464d-8719-12c2f1aab5d5.html,,,,,, Benzyltrimethylammonium chloride,56-93-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca9c35d7-1cc8-4711-85a6-3bf328457d32/documents/IUC5-edd3271c-c42d-4123-a432-23e0cb9cefa2_b78a072d-8396-464d-8719-12c2f1aab5d5.html,,oral,LD50,115 mg/kg bw,adverse effect observed, Benzyltrimethylammonium chloride,56-93-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca9c35d7-1cc8-4711-85a6-3bf328457d32/documents/IUC5-edd3271c-c42d-4123-a432-23e0cb9cefa2_b78a072d-8396-464d-8719-12c2f1aab5d5.html,,dermal,LD50,510 mg/kg bw,adverse effect observed, Benzyltrimethylammonium chloride,56-93-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca9c35d7-1cc8-4711-85a6-3bf328457d32/documents/IUC5-edd3271c-c42d-4123-a432-23e0cb9cefa2_b78a072d-8396-464d-8719-12c2f1aab5d5.html,,inhalation,LC50,"1,140 mg/m3",adverse effect observed, Benzyltrimethylammonium hydroxide,100-85-6," A combined 28-day repeated dose toxicity study with reproduction/developmental toxicity screening test was performed according to OECD TG 422 with BTMAOH. Due to mortality at the dose level of 15 mg/kg bw/day, the NOAEL was concluded to be 5 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b0a53dd-6c02-4c8d-b57e-4afa2256bd1b/documents/8016a85e-affc-422a-ac10-44365cca3263_a4b07c1a-2b01-4106-90be-cbb829f8f053.html,,,,,, Benzyltrimethylammonium hydroxide,100-85-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b0a53dd-6c02-4c8d-b57e-4afa2256bd1b/documents/8016a85e-affc-422a-ac10-44365cca3263_a4b07c1a-2b01-4106-90be-cbb829f8f053.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat Benzyltrimethylammonium hydroxide,100-85-6, Acute toxicity testing is waived as the substance is classified as skin corrosion Category 1A. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b0a53dd-6c02-4c8d-b57e-4afa2256bd1b/documents/d6114424-b4a7-4304-8dcf-bdcc763a8c3b_a4b07c1a-2b01-4106-90be-cbb829f8f053.html,,,,,, Benzyltriphenylphosphonium chloride,1100-88-5," Based on the results of a 14-day repeated exposure to respirable BTPPC particles by inhalation in male rats followed by a 14-day recovery period LOAEC: 15 mg/m3, based on microscopic lesions in lungs and nasal cavities, and lower body weights NOAEC: 5.1 mg/m3 Some of the effects observed at the highest concentration of 60 mg/m3 were still present following a 14-day recovery period. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6f905be-31e5-4050-959c-0dbba14d9640/documents/22a87ab8-4d98-49c3-bdf3-e684efa003fc_2b5c0f30-15f3-41e6-9fb5-434a1093a4b4.html,,,,,, Benzyltriphenylphosphonium chloride,1100-88-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6f905be-31e5-4050-959c-0dbba14d9640/documents/22a87ab8-4d98-49c3-bdf3-e684efa003fc_2b5c0f30-15f3-41e6-9fb5-434a1093a4b4.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,5.1 mg/m3,,rat Benzyltriphenylphosphonium chloride,1100-88-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6f905be-31e5-4050-959c-0dbba14d9640/documents/22a87ab8-4d98-49c3-bdf3-e684efa003fc_2b5c0f30-15f3-41e6-9fb5-434a1093a4b4.html,Repeated dose toxicity – local effects,inhalation,NOAEC,5.1 mg/m3,adverse effect observed,rat Benzyltriphenylphosphonium chloride,1100-88-5, Acute oral toxicity: Standard Acute method (similar to OECD TG 401)/ 5 male rats per dose oral LD50 = 43 mg/kg bw Acute inhalation toxicity: Standard acute toxicity method/6 male rats per group exposed for 4 hours to particles of 2.0 to 2.6 µm MMAD The lowest lethal concentration was 130 mg/m3. The approximate LC50 was estimated to be between 80 and 200 mg/m3. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6f905be-31e5-4050-959c-0dbba14d9640/documents/ddddbf2c-1dfa-4ce2-8b42-9a4944992e8d_2b5c0f30-15f3-41e6-9fb5-434a1093a4b4.html,,,,,, Benzyltriphenylphosphonium chloride,1100-88-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6f905be-31e5-4050-959c-0dbba14d9640/documents/ddddbf2c-1dfa-4ce2-8b42-9a4944992e8d_2b5c0f30-15f3-41e6-9fb5-434a1093a4b4.html,,oral,LD50,43 mg/kg bw,adverse effect observed, Benzyltriphenylphosphonium chloride,1100-88-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6f905be-31e5-4050-959c-0dbba14d9640/documents/ddddbf2c-1dfa-4ce2-8b42-9a4944992e8d_2b5c0f30-15f3-41e6-9fb5-434a1093a4b4.html,,inhalation,LC50,125 mg/m3,adverse effect observed, "Benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1)",75768-65-9, Read across from source substance: Subacute repeat oral dose toxicity study (OECD 407): NOAEL 10 mg/kg bw/day (Umano 2012) Combined repeat dose toxicity study with reproductive toxicity screening (OECD 422): NOAEL 30 mg/kg/day; Anon (2011) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/852dd37a-7c6f-43f2-87ea-5e28fd3c2008/documents/d211c7a7-586e-4f01-9380-1c5cdd142427_67a96887-b168-495c-89a1-d01a439ac30d.html,,,,,, "Benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1)",75768-65-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/852dd37a-7c6f-43f2-87ea-5e28fd3c2008/documents/d211c7a7-586e-4f01-9380-1c5cdd142427_67a96887-b168-495c-89a1-d01a439ac30d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "Benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1)",75768-65-9, Key Study: Acute Oral Toxicity Study of BTPP:BPA salt in Rats (Up & Down Procedure) OECD 420; Oral Rat LD50 > 2000 mg/Kg bw; Reliability=K1; Supporting study: Oral Rat LD50 is 4385 mg/Kg of bw; Reliability=K2; ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/852dd37a-7c6f-43f2-87ea-5e28fd3c2008/documents/7689e443-d3d4-47bc-8fe5-67e9ada7bfbb_67a96887-b168-495c-89a1-d01a439ac30d.html,,,,,, "Benzyltriphenylphosphonium, salt with 4,4'-[2,2,2-trifluoro-1-(trifluoromethyl)ethylidene]bis[phenol] (1:1)",75768-65-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/852dd37a-7c6f-43f2-87ea-5e28fd3c2008/documents/7689e443-d3d4-47bc-8fe5-67e9ada7bfbb_67a96887-b168-495c-89a1-d01a439ac30d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Betahistine,5638-76-6, Acute toxicity: oral. Supporting study: Based on the available data the oral LD50 for betahistine was determined to be 2920 mg/kg in mouse. Acute toxicity: oral. Supporting study: Based on the available data the oral LD50 for betahistine was determined to be 6110 mg/kg in rat. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2edad18-740c-4391-8549-02400df53bfa/documents/24377c0c-2d58-4611-9c20-b19463e210c0_adf0bc75-2d4c-4453-b884-1b8057fe3d0c.html,,,,,, Betahistine,5638-76-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2edad18-740c-4391-8549-02400df53bfa/documents/24377c0c-2d58-4611-9c20-b19463e210c0_adf0bc75-2d4c-4453-b884-1b8057fe3d0c.html,,oral,LD50,"2,920 mg/kg bw",no adverse effect observed, Betaine hydrochloride,590-46-5, NOAEL oral rat subacute ≥ 7567 mg betaine hydrochloride/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5401300f-af11-4ac4-a704-4446ef217a85/documents/87705b90-7301-4aa0-8c3b-737591ab382d_df6877b3-d060-4ad3-a8b2-692e601d5cf1.html,,,,,, Betaine hydrochloride,590-46-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5401300f-af11-4ac4-a704-4446ef217a85/documents/87705b90-7301-4aa0-8c3b-737591ab382d_df6877b3-d060-4ad3-a8b2-692e601d5cf1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"7,567 mg/kg bw/day",,rat Betaine hydrochloride,590-46-5, LD50 Acute Oral rat ≥5000 mg betaine hydrochloride /kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5401300f-af11-4ac4-a704-4446ef217a85/documents/ea88e4f2-4d83-4958-9807-0f755ee66d40_df6877b3-d060-4ad3-a8b2-692e601d5cf1.html,,,,,, Betaine hydrochloride,590-46-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5401300f-af11-4ac4-a704-4446ef217a85/documents/ea88e4f2-4d83-4958-9807-0f755ee66d40_df6877b3-d060-4ad3-a8b2-692e601d5cf1.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "(1R,2R,4S)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-yl acetate",4057-31-2,"Key study: Test method similar to OECD 408. No data on GLP. Based on the read-across approach, the NOEL for dextro alpha fenchyl acetate after an oral exposure of 13 weeks was determined to be 15 mg/kg bw/day in rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6291820e-9004-4085-89b9-1fafe73ff8cb/documents/IUC5-8c9eda5e-6476-4e28-bd86-8b3ae09a50a7_f5ca2e6c-9139-4bfe-83f7-ecd660f52af1.html,,,,,, "(1R,2R,4S)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-yl acetate",4057-31-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6291820e-9004-4085-89b9-1fafe73ff8cb/documents/IUC5-8c9eda5e-6476-4e28-bd86-8b3ae09a50a7_f5ca2e6c-9139-4bfe-83f7-ecd660f52af1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "(1R,2R,4S)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-yl acetate",4057-31-2,"Acute toxicity, oral: Key studies: Based on the read-across approach, the oral LD50 of dextro alpha fenchyl acetate was >10000 mg/kg bw/day in rats and 9000 mg/kg bw/day in mice. Acute toxicity, dermal: Key study: Based on the read-across approach, the dermal LD50 of dextro alpha fenchyl acetate was > 20000 mg/kg bw/day in rabbits. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6291820e-9004-4085-89b9-1fafe73ff8cb/documents/IUC5-18721e21-9233-4752-9005-47ee5be179c0_f5ca2e6c-9139-4bfe-83f7-ecd660f52af1.html,,,,,, "(1R,2R,4S)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-yl acetate",4057-31-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6291820e-9004-4085-89b9-1fafe73ff8cb/documents/IUC5-18721e21-9233-4752-9005-47ee5be179c0_f5ca2e6c-9139-4bfe-83f7-ecd660f52af1.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "(1R,2R,4S)-1,3,3-trimethylbicyclo[2.2.1]heptan-2-yl acetate",4057-31-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6291820e-9004-4085-89b9-1fafe73ff8cb/documents/IUC5-18721e21-9233-4752-9005-47ee5be179c0_f5ca2e6c-9139-4bfe-83f7-ecd660f52af1.html,,dermal,LD50,"20,000 mg/kg bw",no adverse effect observed, Bicyclo[2.2.1]heptanebis(methylamine),56602-77-8," Oral 28 -day NOAEL 15 mg/kg bw/day (rat), Guidelines for Toxicity Studies of Drugs (Notification No. 24 of the First Evaluation and Registration Division, 1989), Kashima Laboratory (1992). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ebca83c6-1108-40af-8bc4-12e6c51832ad/documents/IUC5-a38be358-d60f-49f5-96d8-d4ab1db402e0_30314da7-93e0-41f6-b3dc-051769d75928.html,,,,,, Bicyclo[2.2.1]heptanebis(methylamine),56602-77-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ebca83c6-1108-40af-8bc4-12e6c51832ad/documents/IUC5-a38be358-d60f-49f5-96d8-d4ab1db402e0_30314da7-93e0-41f6-b3dc-051769d75928.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,450 mg/kg bw/day,,rat Bicyclo[2.2.1]heptanebis(methylamine),56602-77-8," Oral LD50 1000 -1400 mg/kg bw (males); LD50 961 mg/kg bw (females) (rat), OECD 401, Chida, T. (1992). Inhalation Data requirement waived - substance is corrosive to skin. Dermal Data requirement waived - substance is corrosive to skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebca83c6-1108-40af-8bc4-12e6c51832ad/documents/a12c8166-770a-4a09-aa91-d9795167f330_30314da7-93e0-41f6-b3dc-051769d75928.html,,,,,, Bicyclo[2.2.1]heptanebis(methylamine),56602-77-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebca83c6-1108-40af-8bc4-12e6c51832ad/documents/a12c8166-770a-4a09-aa91-d9795167f330_30314da7-93e0-41f6-b3dc-051769d75928.html,,oral,LD50,961 mg/kg bw,adverse effect observed, "Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, phosphosulfurized",67762-73-6,"The acute oral median lethal dose (LD50) of the registered substance in male Sprague-Dawley rats was estimated to be greater than 10,000 mg/kg bw. The registered substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures.The acute dermal median lethal dose (LD50) of the registered substance in New Zealand white rabbits was estimated to be greater than 3160 mg/kg bw. The registered substance did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfafe13a-0489-446b-bb14-5225bf4a2ab0/documents/IUC5-f877fe0c-bdf1-49d3-84fd-9fcbaa8c93ca_0c293aa0-8a57-44b1-ac1e-e4538b667070.html,,,,,, "Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, phosphosulfurized",67762-73-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfafe13a-0489-446b-bb14-5225bf4a2ab0/documents/IUC5-f877fe0c-bdf1-49d3-84fd-9fcbaa8c93ca_0c293aa0-8a57-44b1-ac1e-e4538b667070.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Bicyclo[3.1.1]hept-2-ene, 2,6,6-trimethyl-, phosphosulfurized",67762-73-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfafe13a-0489-446b-bb14-5225bf4a2ab0/documents/IUC5-f877fe0c-bdf1-49d3-84fd-9fcbaa8c93ca_0c293aa0-8a57-44b1-ac1e-e4538b667070.html,,dermal,LD50,"3,160 mg/kg bw",no adverse effect observed, "(1R,5S)-2-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl) ethyl acetate",35836-72-7,"An oral diet repeated dose toxicity study was conducted with nopyl acetate according to OECD Guideline No 408 and in compliance with GLP.The NOAEL (No Observed Adverse Effect Level) for systemic toxicity was considered to be 7500 ppm in males and 3500 ppm in females based on body weight effects (equivalent to 467 mg/kg bw/day in males and 249 mg/kg bw/day in females). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP study according to OECD guideline 408 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ebabcf38-f7bc-4361-9239-79c72402bacc/documents/279e1322-41d6-4182-a199-c0eb6484e751_e9012aad-3dab-4778-9198-bcb6ffdb18cd.html,,,,,, "(1R,5S)-2-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl) ethyl acetate",35836-72-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ebabcf38-f7bc-4361-9239-79c72402bacc/documents/279e1322-41d6-4182-a199-c0eb6484e751_e9012aad-3dab-4778-9198-bcb6ffdb18cd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,249 mg/kg bw/day,,rat "(1R,5S)-2-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl) ethyl acetate",35836-72-7,"In an acute oral toxicity study (similar to OECD guideline 401) performed in mice, the LD50 was between 1960 and 4900 mg/kg bw.In an acute dermal toxicity study (similar to OECD guideline 402) performed in rabbits, the LD50 was higher than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebabcf38-f7bc-4361-9239-79c72402bacc/documents/IUC5-6329b4f9-0bfc-4bff-bee8-231b2bcf320a_e9012aad-3dab-4778-9198-bcb6ffdb18cd.html,,,,,, "(1R,5S)-2-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl) ethyl acetate",35836-72-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebabcf38-f7bc-4361-9239-79c72402bacc/documents/IUC5-6329b4f9-0bfc-4bff-bee8-231b2bcf320a_e9012aad-3dab-4778-9198-bcb6ffdb18cd.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(1R,5S)-2-(6,6-dimethylbicyclo[3.1.1]hept-2-en-2-yl) ethyl acetate",35836-72-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebabcf38-f7bc-4361-9239-79c72402bacc/documents/IUC5-6329b4f9-0bfc-4bff-bee8-231b2bcf320a_e9012aad-3dab-4778-9198-bcb6ffdb18cd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Biphenyl,92-52-4,"Oral (dietary) exposure route:Five Klimisch 2 studies are available. The NOAEL was based on the 2-year study in male/female rats of Umeda et al. (2002) as this study shows the lowest NOAEL, which is 38 mg/kg bw/d (recalculated from the dietary concentration of 500 ppm). The study was performed according to OECD Guideline 453.Dermal exposure route:Only two Klimisch 4 studies were available. Based on these studies, no key NOAEL could be defined.Inhalation exposure route:Only one Klimisch 4 study was available. Based on this study, no key NOAEC could be defined. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43c73182-f49d-4d80-8045-e6fa75df03f8/documents/d598d491-0e2d-4100-a39d-558589c25ad2_95905a06-be8f-433f-bc14-e2731a5bfaeb.html,,,,,, Biphenyl,92-52-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43c73182-f49d-4d80-8045-e6fa75df03f8/documents/d598d491-0e2d-4100-a39d-558589c25ad2_95905a06-be8f-433f-bc14-e2731a5bfaeb.html,Chronic toxicity – systemic effects,oral,NOAEL,38 mg/kg bw/day,,rat Biphenyl,92-52-4,"Acute toxicity oral:The reliability of all available studies was not assignable (Klimisch 4). A weight of evidence approach is followed using all these studies. The rat LD50 for biphenyl ranged between 2180 mg/kg bw and 5040 mg/kg bw.Acute toxicity inhalation:The reliability of all available studies was not assignable (Klimisch 4). Acute inhalation studies of Haley et al. (1959), Birch (1976), Younger (1959) and Shewbart (1974) were used in a weight of evidence approach. Only unbounded effect concentrations were available. The highest LC50 value in rats was > 3.47 mg/L (1 hour of exposure).Acute dermal toxicity:Here also, the reliability of all available studies was not assignable (Klimisch 4). The two available studies (Birch, 1976; Rampy et al., 1974) were used in a weight of evidence approach. Only unbounded effect concentrations were available. The highest LD50 value (for New Zealand White rabbit) was > 5010 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43c73182-f49d-4d80-8045-e6fa75df03f8/documents/6b579983-372b-4317-9396-1d555483d494_95905a06-be8f-433f-bc14-e2731a5bfaeb.html,,,,,, "Biphenyl-2-ol, ethoxylated, esters with acrylic acid",72009-86-0," Oral exposure: No data is available on Biphenyl-2-ol, ethoxylated, esters with acrylic acid (T). From an OECD 422 screening study with the source substance , 2-phenoxyethyl acrylate, an oral NOAEL in relation to systemic efects was established to 300 mg/kg bw/day based on increase in liver weights in both sexes (and increased kidney weight in males) at 800 mg/kg/d. For local effects in the forestomach an oral NOAEL of 100 mg/kg bw/day was established.   In an OECD Guideline 408 study, Wistar rats (10 animals per sex/ dose level) were dosed by gavage during 90 days at levels of 0, 30, 100 and 350 mg/kg/day. No unscheduled deaths occurred, and there were no toxicological findings in relation to clinical observation or pathological findings.Salivation at the dose level of 350 mg/kg/day was considered as a test item palatability response and only slight differences in clinical laboratory investigations and some slight changes in organ weights at the high dose level were noted. Under the conditions of this study the dose of 350 mg/kg/day is to be considered as a NOAEL both in relation to systemic effects as well as local effects.   It is to be noted that 350 mg/kg bw/day was selected as the highest dose level for the study as inflammatory infiltrates in submucosa and forestomach ulcerations was observed at dose levels of 300 mg/kg bw/day and 800 mg/kg bw/day in the OECD 422 study. Thus, for longer term exposure an adaptation to the gastric irritational effects seems to occur as such effects were not observed in this 90D study at 350 mg/kg/d. Based on read-across the same NOAEL values 350mg/kg bw/day (systemic) and 100mg/kg bw/day (local) for repeated dose toxicity should apply for the target substance (T).    See justification for read-across attached in section 13. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a86e08e0-8569-4c2a-92b3-9d071941ea91/documents/0a2107b5-d1da-4ca9-8945-64a647b35208_d6078d35-674b-4f8c-b2f6-fbbdaf6d05fe.html,,,,,, "Biphenyl-2-ol, ethoxylated, esters with acrylic acid",72009-86-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a86e08e0-8569-4c2a-92b3-9d071941ea91/documents/0a2107b5-d1da-4ca9-8945-64a647b35208_d6078d35-674b-4f8c-b2f6-fbbdaf6d05fe.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,350 mg/kg bw/day,,rat "Biphenyl-2-ol, ethoxylated, esters with acrylic acid",72009-86-0,"  Acute toxicity, oral:  An OECD 423 test in rats resulted in LD50 > 2000 mg/kg using Biphenyl-2-ol, ethoxylated, esters with acrylic acid as test material. The available studies on acute toxicity of 2-phenoxyethyl acrylate show that this substance as well has low acute toxicity with LD50 in rats > 5000 mg/kg. Thus, the similar findings support the read-across used for the toxicological evaluation of Biphenyl-2-ol, ethoxylated, esters with acrylic acid. Acute toxicity, inhalation: No data is available on either Biphenyl-2-ol, ethoxylated, esters with acrylic acid or 2-phenoxyethyl acrylate Acute toxicity, dermal:  No data is available on o-phenylphenolethyl acrylate. The available studies on acute toxicity of 2-phenoxyethyl acrylate show that the substance has low acute toxicity with LD50 in rats > 2000 mg/kg bw . This value may be considered relevant foro-phenylphenolethyl acrylateas well. Acute toxicity, dermal:  No data is available on Biphenyl-2-ol, ethoxylated, esters with acrylic acid. The available studies on acute toxicity of 2-phenoxyethyl acrylate show that the substance has low acute toxicity with LD50 in rats > 2000 mg/kg bw . This value may be considered relevant for Biphenyl-2-ol, ethoxylated, esters with acrylic acid as well. See read-across justification attached in section 13. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a86e08e0-8569-4c2a-92b3-9d071941ea91/documents/24106e4f-fcdb-4ffa-a97a-b59a2a7e79b9_d6078d35-674b-4f8c-b2f6-fbbdaf6d05fe.html,,,,,, "Biphenyl-2-ol, ethoxylated, esters with acrylic acid",72009-86-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a86e08e0-8569-4c2a-92b3-9d071941ea91/documents/24106e4f-fcdb-4ffa-a97a-b59a2a7e79b9_d6078d35-674b-4f8c-b2f6-fbbdaf6d05fe.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Biphenyl-2-ol, ethoxylated, esters with acrylic acid",72009-86-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a86e08e0-8569-4c2a-92b3-9d071941ea91/documents/24106e4f-fcdb-4ffa-a97a-b59a2a7e79b9_d6078d35-674b-4f8c-b2f6-fbbdaf6d05fe.html,,dermal,discriminating dose,"2,000 mg/kg bw",adverse effect observed, "Biphenyl-2-yl-(9,9-dimethyl-9H-fluoren-2-yl)-(9,9’-spirobifluoren-4-yl)-amine",1450933-44-4, The acute oral toxicity of a structural analogue substance was determined in a study according to OECD Guideline 423 under GLP conditions. The LD50 value was determined to be greater than 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b1fa459-544d-4b3f-bddf-8e118d8d52ae/documents/2d040a9f-57e1-42db-874b-1cc5f028532f_869ca40d-3154-4f05-9f84-a9ac6d9f7c61.html,,,,,, "Biphenyl-2-yl-(9,9-dimethyl-9H-fluoren-2-yl)-(9,9’-spirobifluoren-4-yl)-amine",1450933-44-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b1fa459-544d-4b3f-bddf-8e118d8d52ae/documents/2d040a9f-57e1-42db-874b-1cc5f028532f_869ca40d-3154-4f05-9f84-a9ac6d9f7c61.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Biphenyl-4,4'-diyl tetrakis(2,6-dimethylphenyl) bisphosphate",147263-99-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): K1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef22b342-1c5c-42aa-980f-b38aeb9c5090/documents/IUC5-aa63fdd1-9c44-44d9-9cce-c2ba21085a81_47147ad3-ebcb-4aa1-9f7e-915917dd48c4.html,,,,,, "Biphenyl-4,4'-diyl tetrakis(2,6-dimethylphenyl) bisphosphate",147263-99-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef22b342-1c5c-42aa-980f-b38aeb9c5090/documents/IUC5-aa63fdd1-9c44-44d9-9cce-c2ba21085a81_47147ad3-ebcb-4aa1-9f7e-915917dd48c4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Biphenyl-4-yl-(9,9-dimethyl-9H-fluoren-2-yl)-[2-(9,9-diphenyl-9H-fluoren-4-yl)-phenyl]-amine",1792219-00-1, The LD50 value of the test item was determined to be greater than 2000 mg/kg bw in rats after oral administration. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f37afbe5-bd36-4f74-8b60-7a6bef23d80a/documents/1933cd0c-f2d5-4e45-9031-e299ca60c4b1_90957abc-e070-4663-89ba-511a6c56f7c6.html,,,,,, "Biphenyl-4-yl-(9,9-dimethyl-9H-fluoren-2-yl)-[2-(9,9-diphenyl-9H-fluoren-4-yl)-phenyl]-amine",1792219-00-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f37afbe5-bd36-4f74-8b60-7a6bef23d80a/documents/1933cd0c-f2d5-4e45-9031-e299ca60c4b1_90957abc-e070-4663-89ba-511a6c56f7c6.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bis (3‐(diethylamino)‐7‐hydroxy‐5‐phenylphenazinium) sulphate,97849-65-5," Acute oral toxicity: Key study. Test method according to OECD 423, GLP study. The LD50 of the test item was found to be higher than 300 mg/kg bw and lower than 2000 mg/kg by oral route in the rat. The LD50 cut-off of the test item may be considered as 1000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a32b4829-3910-4c91-b0c1-7a60f1481385/documents/fbc2c86e-136c-46d6-bc01-a383f4b8a4c5_c47cab24-bc88-4b47-90c8-06d5e5272ac4.html,,,,,, Bis (3‐(diethylamino)‐7‐hydroxy‐5‐phenylphenazinium) sulphate,97849-65-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a32b4829-3910-4c91-b0c1-7a60f1481385/documents/fbc2c86e-136c-46d6-bc01-a383f4b8a4c5_c47cab24-bc88-4b47-90c8-06d5e5272ac4.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, "Bis(1,2,2,6,6-pentamethyl-4-piperidinyl) 2-(4-methoxybenzylidene)malonate",147783-69-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b4e1e93-62bc-4eb2-b669-439ebb530350/documents/785864b5-3f48-4cc2-bd95-bdb13a4e2292_52285fa0-cbac-45bd-9e58-c48501ae5a4e.html,,oral,LD50,"ca.2,195 mg/kg bw",adverse effect observed, "Bis(1,2,2,6,6-pentamethyl-4-piperidinyl) 2-(4-methoxybenzylidene)malonate",147783-69-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b4e1e93-62bc-4eb2-b669-439ebb530350/documents/785864b5-3f48-4cc2-bd95-bdb13a4e2292_52285fa0-cbac-45bd-9e58-c48501ae5a4e.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Bis(1,2,2,6,6-pentamethyl-4-piperidyl) [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]butylmalonate",63843-89-0,"The substance causes granulomatous inflammation in intestine, spleen and liver upon subacute oral exposure to low doses (Ciba-Geigy 1979, BASF 2012a and b). A NOAEL of 2 mg/kg bw for subacute oral dosing was identified (BASF 2012b) and the mesenteric lymph nodes were found to be the most sensitive organ. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0178f71e-ea74-4541-8de5-a6228cfa55bf/documents/IUC5-16edea2e-33b2-45bf-b363-729d8ce343d0_36769488-1cc5-4659-8a96-d51d10c39974.html,,,,,, "Bis(1,2,2,6,6-pentamethyl-4-piperidyl) [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]butylmalonate",63843-89-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0178f71e-ea74-4541-8de5-a6228cfa55bf/documents/IUC5-16edea2e-33b2-45bf-b363-729d8ce343d0_36769488-1cc5-4659-8a96-d51d10c39974.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,2 mg/kg bw/day,,rat "Bis(1,2,2,6,6-pentamethyl-4-piperidyl) [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]butylmalonate",63843-89-0,"The substance caused acute toxicity in rats with an LD50 of 1490 mg/kg bw. Morality occured with a delay of one to two weeks at the lower tested doses. No target organ could be identified upon necropsy. No adverse effects were observed in rats upon a single 24h occlusive application of 3100 mg/kg bw within the 2-week observation period. No adverse effects were observed after a 4h dust exposure to 0.49 mg/L during the 2-week observation period. All studies were performed prior existance of GLP and OECD testing guideline, but are comparable both in study design and reporting. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0178f71e-ea74-4541-8de5-a6228cfa55bf/documents/IUC5-8ba069d9-0f23-4ec7-9134-633f745e261e_36769488-1cc5-4659-8a96-d51d10c39974.html,,,,,, "Bis(1,2,2,6,6-pentamethyl-4-piperidyl) [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]butylmalonate",63843-89-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0178f71e-ea74-4541-8de5-a6228cfa55bf/documents/IUC5-8ba069d9-0f23-4ec7-9134-633f745e261e_36769488-1cc5-4659-8a96-d51d10c39974.html,,oral,LD50,"1,490 mg/kg bw",adverse effect observed, "Bis(1,2,2,6,6-pentamethyl-4-piperidyl) [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]butylmalonate",63843-89-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0178f71e-ea74-4541-8de5-a6228cfa55bf/documents/IUC5-8ba069d9-0f23-4ec7-9134-633f745e261e_36769488-1cc5-4659-8a96-d51d10c39974.html,,dermal,discriminating dose,"3,170 mg/kg bw",no adverse effect observed, "Bis(1,2,2,6,6-pentamethyl-4-piperidyl) [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]butylmalonate",63843-89-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0178f71e-ea74-4541-8de5-a6228cfa55bf/documents/IUC5-8ba069d9-0f23-4ec7-9134-633f745e261e_36769488-1cc5-4659-8a96-d51d10c39974.html,,inhalation,discriminating conc.,460 mg/m3,no adverse effect observed, Bis(2-(2-butoxyethoxy)ethoxy)methane,143-29-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/46853886-af7c-4497-a01f-2b037029da3d/documents/IUC5-2545b8f1-d089-4750-a597-41076fd0bd9e_b8310764-29a7-4b45-ab8b-0abcfa078ef0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat Bis(2-(2-butoxyethoxy)ethoxy)methane,143-29-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46853886-af7c-4497-a01f-2b037029da3d/documents/IUC5-c8196733-8dae-418f-b55a-55417d9de1e0_b8310764-29a7-4b45-ab8b-0abcfa078ef0.html,,oral,LD50,"2,000 mg/kg bw",, Bis(2-(2-butoxyethoxy)ethoxy)methane,143-29-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46853886-af7c-4497-a01f-2b037029da3d/documents/IUC5-c8196733-8dae-418f-b55a-55417d9de1e0_b8310764-29a7-4b45-ab8b-0abcfa078ef0.html,,dermal,LD50,"2,000 mg/kg bw",, Bis(2-(2-butoxyethoxy)ethyl) adipate,141-17-3," Subchronic toxicity (OECD 408, GLP) oral: NOAEL (rat): 300 and 100 mg/kg bw/day in males and females, respectively ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2788f02f-f50b-440e-a925-31d1fcf1874a/documents/IUC5-b845991b-de67-4b19-b841-ce70d289222b_897fcbae-5940-4a87-8eec-e555ec00acf3.html,,,,,, Bis(2-(2-butoxyethoxy)ethyl) adipate,141-17-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2788f02f-f50b-440e-a925-31d1fcf1874a/documents/IUC5-b845991b-de67-4b19-b841-ce70d289222b_897fcbae-5940-4a87-8eec-e555ec00acf3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Bis(2-(2-butoxyethoxy)ethyl) adipate,141-17-3,"Oral (similar to OECD 401), rat: LD50 > 5000 mg/kg bw (limit test)Dermal (OECD 402), rabbit: LD50 > 5000 mg/kg bw (limit test) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2788f02f-f50b-440e-a925-31d1fcf1874a/documents/IUC5-f57cb4ea-7122-4692-9124-c21b9f13b76d_897fcbae-5940-4a87-8eec-e555ec00acf3.html,,,,,, "bis(2,2,6,6-tetramethyl-1-(phenylthio)piperidin-4-yl)carbonate",1771689-37-2," rat, oral, OECD 423, class method, limit test, LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/104ce5e6-470a-4ace-8162-61631f1cfe23/documents/ac8f8146-e2df-47a4-8b52-ccbca62c6f6d_c874d392-6281-40e2-871f-361bc1187a61.html,,,,,, "bis(2,2,6,6-tetramethyl-1-(phenylthio)piperidin-4-yl)carbonate",1771689-37-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/104ce5e6-470a-4ace-8162-61631f1cfe23/documents/ac8f8146-e2df-47a4-8b52-ccbca62c6f6d_c874d392-6281-40e2-871f-361bc1187a61.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate",52829-07-9," In all repeated dose oral toxicity studies in rats and dogs, administration of test material was associated with decreased body weight gain. The 28-day NOAEL for oral toxicity (gavage) in rats was 50 mg/kg bw based on reduced body weight gain and distension of stomach and small intestine. In an OECD 422 study, additional histological changes in the heart in males were reported, which were, however, not confirmed in a follow-up OECD 443 study with 10 week premating treatment. In this OECD 443, effects on body weights were also reported with a NOAEL of 36 mg/kg body weight. The 90-day NOEL for oral toxicity (gavage) in rats was < 29 mg/kg bw based on reduced body weight gain in females. However, since the study also reported inflammation in all dose groups, the reliability of this study may have been compromised, as confirmed by ECHA in their final decision (Decision number: CCH-D-2114384240-56-01/F). Finally, the 90-day NOAEL for oral toxicity (feed) in dogs was 2600 ppm (69-78 mg/kg bw) based on decreased body weight and liver hypertrophy. The most reliable systemic NOAEL was is considered the NOAEL of 36 mg/kg body weight derived in the OECD 443 study (see chapter 7.8.1). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b9f983c-0465-4752-bba5-781fce132ab5/documents/5be8f69a-f156-42ab-a928-075c8dee6afe_576d6a14-bae4-4d70-b097-ec5160261332.html,,,,,, "Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate",52829-07-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b9f983c-0465-4752-bba5-781fce132ab5/documents/5be8f69a-f156-42ab-a928-075c8dee6afe_576d6a14-bae4-4d70-b097-ec5160261332.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,36 mg/kg bw/day,,rat "Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate",52829-07-9, The following LD 50 values were derived: oral LD50 in rats: 3700 mg/kg bw dermal LD50 in rats: > 3170 mg/kg bw (rat) inhalation LC50 in rats: 0.5 mg/l (rat) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b9f983c-0465-4752-bba5-781fce132ab5/documents/5eed463a-5b5c-48f9-86ef-c49589d47a60_576d6a14-bae4-4d70-b097-ec5160261332.html,,,,,, "Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate",52829-07-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b9f983c-0465-4752-bba5-781fce132ab5/documents/5eed463a-5b5c-48f9-86ef-c49589d47a60_576d6a14-bae4-4d70-b097-ec5160261332.html,,oral,LD50,"3,700 mg/kg bw",adverse effect observed, "Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate",52829-07-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b9f983c-0465-4752-bba5-781fce132ab5/documents/5eed463a-5b5c-48f9-86ef-c49589d47a60_576d6a14-bae4-4d70-b097-ec5160261332.html,,dermal,LD50,"3,170 mg/kg bw",no adverse effect observed, "Bis(2,2,6,6-tetramethyl-4-piperidyl) sebacate",52829-07-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b9f983c-0465-4752-bba5-781fce132ab5/documents/5eed463a-5b5c-48f9-86ef-c49589d47a60_576d6a14-bae4-4d70-b097-ec5160261332.html,,inhalation,LC50,500 mg/m3,adverse effect observed, "Bis(2,3-epoxypropyl) cyclohex-4-ene-1,2-dicarboxylate",21544-03-6," - Repeated dose toxicity: oral: The OECD Guidelines N°408: Subchromic Oral Toxicity-Rodent 90 Day Study"" was performed. A NOAEL of 350 mg/ kg bw/day for both males and females was determined for systemic toxicity. - Repeated dose toxicity: inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. - Repeated dose toxicity: dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure . ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f75ede16-f21b-4182-a416-a743c5ad631a/documents/cecb0574-947c-4520-9a6f-ffdfb3459e29_5dee2397-535e-48ac-bd95-1a3412d2be3e.html,,,,,, "Bis(2,3-epoxypropyl) cyclohex-4-ene-1,2-dicarboxylate",21544-03-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f75ede16-f21b-4182-a416-a743c5ad631a/documents/cecb0574-947c-4520-9a6f-ffdfb3459e29_5dee2397-535e-48ac-bd95-1a3412d2be3e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,175 mg/kg bw/day,,rat "Bis(2,3-epoxypropyl) cyclohex-4-ene-1,2-dicarboxylate",21544-03-6, OECD 401: The acute oral LD50 of the test item in rats of both sexes observed over a period of 14 days is 2938 (2453-3518) mg/kg . OECD 402: The acute dermal LD50 of the test item in rats of both sexes observed over a period of 14 days is greater than 4600 mg/kg. Acute inhalation toxicty study was waived as acute toxicity studies are available for the oral and dermal routes of exposure and because of the low Vapor pressure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f75ede16-f21b-4182-a416-a743c5ad631a/documents/4e0687e8-9b25-4df7-b9d5-5753dda0c00d_5dee2397-535e-48ac-bd95-1a3412d2be3e.html,,,,,, "Bis(2,3-epoxypropyl) cyclohex-4-ene-1,2-dicarboxylate",21544-03-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f75ede16-f21b-4182-a416-a743c5ad631a/documents/4e0687e8-9b25-4df7-b9d5-5753dda0c00d_5dee2397-535e-48ac-bd95-1a3412d2be3e.html,,oral,LD50,"2,938 mg/kg bw",no adverse effect observed, "Bis(2,3-epoxypropyl) cyclohex-4-ene-1,2-dicarboxylate",21544-03-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f75ede16-f21b-4182-a416-a743c5ad631a/documents/4e0687e8-9b25-4df7-b9d5-5753dda0c00d_5dee2397-535e-48ac-bd95-1a3412d2be3e.html,,dermal,LD50,"4,600 mg/kg bw",no adverse effect observed, "Bis(2,3-epoxypropyl) phthalate",7195-45-1, Oral Toxicity The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight (Globally Harmonized Classification System - Category 4). Dermal Toxicity The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight. The test item does not meet the criteria for classification according to the Globally Harmonized System of Classification and Labelling of Chemicals. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff3bf535-b3a8-4875-9f79-1844304ea9c4/documents/b1b92a25-8502-451a-a478-9079ff63bdda_3d7fc4da-77ae-4336-a44a-77b9f2b1c2ef.html,,,,,, "Bis(2,4,4-trimethylpentyl)phosphinic acid",83411-71-6,"OECD TG 422: NOAEL (male, parental toxicity) = 66.7 mg/kg bw/day. OECD TG 422: NOAEL (female, parental toxicity) = 200 mg/kg bw/day. OECD TG 408: NOAEL (male/female) = 70 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05366a11-35f4-44b7-8548-c1a743f30480/documents/c8429cd5-1289-42d6-8bc0-94c8fec7a3f5_38671adb-0de1-4298-b944-ea8fdfd547fa.html,,,,,, "Bis(2,4,4-trimethylpentyl)phosphinic acid",83411-71-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05366a11-35f4-44b7-8548-c1a743f30480/documents/c8429cd5-1289-42d6-8bc0-94c8fec7a3f5_38671adb-0de1-4298-b944-ea8fdfd547fa.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,66.7 mg/kg bw/day,,rat "Bis(2,4,4-trimethylpentyl)phosphinic acid",83411-71-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05366a11-35f4-44b7-8548-c1a743f30480/documents/c8429cd5-1289-42d6-8bc0-94c8fec7a3f5_38671adb-0de1-4298-b944-ea8fdfd547fa.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,70 mg/kg bw/day,,rat "Bis(2,4,4-trimethylpentyl)phosphinic acid",83411-71-6,"Oral: LD50 (rat, male and female) = 5444 mg/kg bw Inhalation: no data available, waiving Dermal: LD50 (rabbit, male/female)> 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05366a11-35f4-44b7-8548-c1a743f30480/documents/aeea6170-b4c0-4b25-b17d-1caa64b330d6_38671adb-0de1-4298-b944-ea8fdfd547fa.html,,,,,, "Bis(2,4,4-trimethylpentyl)phosphinic acid",83411-71-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05366a11-35f4-44b7-8548-c1a743f30480/documents/aeea6170-b4c0-4b25-b17d-1caa64b330d6_38671adb-0de1-4298-b944-ea8fdfd547fa.html,,oral,LD50,"5,444 mg/kg bw",no adverse effect observed, "Bis(2,4,4-trimethylpentyl)phosphinic acid",83411-71-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05366a11-35f4-44b7-8548-c1a743f30480/documents/aeea6170-b4c0-4b25-b17d-1caa64b330d6_38671adb-0de1-4298-b944-ea8fdfd547fa.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Bis(2,4-dichlorobenzoyl) peroxide",133-14-2,"Data from a 90-day repeated dose oral gavage study (OECD 408; GLP) revealed that 100 and 300 mg/kg bw/d are NOAEL in males and females, respectively. The NOAEL for males was chosen as the most sensitive NOAEL for this substance. Data from a previously performed 28day repeated dose oral gavage study (OECD 407, GLP), showed 300 mg/kg bw/d as the NOAEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/512ece33-4b71-4929-a92f-fb836f7595db/documents/IUC5-4c71b45f-e0b0-414c-b4f0-ee073dab349a_bf133867-bfdc-43e2-84c6-c91140e4e94b.html,,,,,, "Bis(2,4-dichlorobenzoyl) peroxide",133-14-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/512ece33-4b71-4929-a92f-fb836f7595db/documents/IUC5-4c71b45f-e0b0-414c-b4f0-ee073dab349a_bf133867-bfdc-43e2-84c6-c91140e4e94b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Bis(2,4-dichlorobenzoyl) peroxide",133-14-2,"The acute oral toxicity of Bis(2,4-dichlorobenzoyl) peroxide, paste, 50% in silicone oil, was determined in rats. The test item was administered orally as a suspension in arachis oil BP. A group of 3 fasted females was treated with the test item at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of 3 fasted females at the same dose level. Clinical signs and bodyweight development were monitored during the 14 day study. All animals were subjected to gross necropsy. There were no deaths or any clinical signs of systemic toxicity. All animals showed expected gains in bodyweight over the study period. No abnormalities were noted at necropsy. It was concluded that the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was greater than 2000 mg/kg bodyweight, and does not meet the criteria for classification under GHS. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/512ece33-4b71-4929-a92f-fb836f7595db/documents/IUC5-a0658568-2425-4759-a3b7-fa6f2581abc3_bf133867-bfdc-43e2-84c6-c91140e4e94b.html,,,,,, "Bis(2,4-dichlorobenzoyl) peroxide",133-14-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/512ece33-4b71-4929-a92f-fb836f7595db/documents/IUC5-a0658568-2425-4759-a3b7-fa6f2581abc3_bf133867-bfdc-43e2-84c6-c91140e4e94b.html,,oral,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, "Bis(2,4-dichlorobenzoyl) peroxide",133-14-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/512ece33-4b71-4929-a92f-fb836f7595db/documents/IUC5-a0658568-2425-4759-a3b7-fa6f2581abc3_bf133867-bfdc-43e2-84c6-c91140e4e94b.html,,dermal,discriminating dose,"8,000 mg/kg bw",no adverse effect observed, "Bis(2,6-diisopropylphenyl)carbodiimide",2162-74-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): High quality (two reliable GLP guideline studies: 28-day study and Screening Test). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03a9cbda-5f8a-4aff-88e8-abc0c7b0fe67/documents/IUC5-9ec08d49-c153-43df-b034-395250830fa9_436054b3-fa2f-40dc-8ee6-a71f7b830a92.html,,,,,, "Bis(2,6-diisopropylphenyl)carbodiimide",2162-74-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03a9cbda-5f8a-4aff-88e8-abc0c7b0fe67/documents/IUC5-9ec08d49-c153-43df-b034-395250830fa9_436054b3-fa2f-40dc-8ee6-a71f7b830a92.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,4 mg/kg bw/day,,rat "Bis(2,6-diisopropylphenyl)carbodiimide",2162-74-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is GLP compliant and has Klimisch score 1. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study is GLP compliant and has Klimisch score 1. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03a9cbda-5f8a-4aff-88e8-abc0c7b0fe67/documents/IUC5-72451c70-b9db-4718-bb8f-381dbc18bf51_436054b3-fa2f-40dc-8ee6-a71f7b830a92.html,,,,,, "Bis(2,6-diisopropylphenyl)carbodiimide",2162-74-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03a9cbda-5f8a-4aff-88e8-abc0c7b0fe67/documents/IUC5-72451c70-b9db-4718-bb8f-381dbc18bf51_436054b3-fa2f-40dc-8ee6-a71f7b830a92.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "Bis(2,6-diisopropylphenyl)carbodiimide",2162-74-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03a9cbda-5f8a-4aff-88e8-abc0c7b0fe67/documents/IUC5-72451c70-b9db-4718-bb8f-381dbc18bf51_436054b3-fa2f-40dc-8ee6-a71f7b830a92.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Bis(2-butoxyethyl) adipate,141-18-4," Wistar rats were administrated with 50, 200 or 350 mg/kg BW/day Bis(2-butoxyethyl)adipate for a period of 90 days oral gavage, the NOAEL was considered to be 50 mg/kg bw/day. Marked changes to haematological parameters seen at 200 ppm and 350 mg/kg/BW /day in terms of reduced blood cells mass, regenerative processes and other associated changes to red blood cell parameters were considered as test item related, adverse effects. Thus, the NOAEL of this study was considered to be 50 mg/Kg BW/day. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/61f74800-4dc7-4311-b88c-0846378b7f6d/documents/IUC5-ff4588dd-11c9-44be-8764-476877c08364_21b9cc8e-aafd-468d-81a2-a66f65fd6555.html,,,,,, Bis(2-butoxyethyl) adipate,141-18-4,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/61f74800-4dc7-4311-b88c-0846378b7f6d/documents/IUC5-ff4588dd-11c9-44be-8764-476877c08364_21b9cc8e-aafd-468d-81a2-a66f65fd6555.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Bis(2-butoxyethyl) adipate,141-18-4,"Key studies were available for acute oral (up-and-down-procedure) and acute dermal toxicity (limit test), demonstrating LD50 values of 1098 and >2000 mg/kg bw, respectively. Acute inhalation toxicity testing was waived based on low vapour pressure. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61f74800-4dc7-4311-b88c-0846378b7f6d/documents/IUC5-ccaf4b12-67ff-40d0-89f4-5b615b8d9807_21b9cc8e-aafd-468d-81a2-a66f65fd6555.html,,,,,, Bis(2-butoxyethyl) adipate,141-18-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61f74800-4dc7-4311-b88c-0846378b7f6d/documents/IUC5-ccaf4b12-67ff-40d0-89f4-5b615b8d9807_21b9cc8e-aafd-468d-81a2-a66f65fd6555.html,,oral,LD50,"1,098 mg/kg bw",, Bis(2-butoxyethyl) adipate,141-18-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61f74800-4dc7-4311-b88c-0846378b7f6d/documents/IUC5-ccaf4b12-67ff-40d0-89f4-5b615b8d9807_21b9cc8e-aafd-468d-81a2-a66f65fd6555.html,,dermal,LD50,"2,000 mg/kg bw",, Bis(2-butoxyethyl) ether,112-73-2,"Upon repeated exposure of rats to DEGDBE toxic effects on hematology, liver, kidney and speen were observed. The red blood cell is the presumed target system, the mode of action being the systemic exposure to 2-butoxyacetic acid. Humans are expected to be less susceptible. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/94ea8d6d-daa0-4646-bfc9-bc675a7c5a0e/documents/IUC5-da115081-234d-4148-8ab8-03c21d67782c_04dff6c5-ed10-452d-898e-17463cda2117.html,,,,,, Bis(2-butoxyethyl) ether,112-73-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/94ea8d6d-daa0-4646-bfc9-bc675a7c5a0e/documents/IUC5-da115081-234d-4148-8ab8-03c21d67782c_04dff6c5-ed10-452d-898e-17463cda2117.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Bis(2-butoxyethyl) ether,112-73-2,DEGDBE is of low acute oral and dermal toxicity. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94ea8d6d-daa0-4646-bfc9-bc675a7c5a0e/documents/IUC5-ec900034-0815-4835-8f97-09773c028753_04dff6c5-ed10-452d-898e-17463cda2117.html,,,,,, Bis(2-butoxyethyl) ether,112-73-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94ea8d6d-daa0-4646-bfc9-bc675a7c5a0e/documents/IUC5-ec900034-0815-4835-8f97-09773c028753_04dff6c5-ed10-452d-898e-17463cda2117.html,,oral,LD50,"3,900 mg/kg bw",no adverse effect observed, Bis(2-butoxyethyl) ether,112-73-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94ea8d6d-daa0-4646-bfc9-bc675a7c5a0e/documents/IUC5-ec900034-0815-4835-8f97-09773c028753_04dff6c5-ed10-452d-898e-17463cda2117.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bis(2-chloroethoxy)methane,111-91-1,"In a 90 day dermal repeated dose study it has been shown that Bis(2-chloroethoxy)methane is cardiotoxic. The Lowest NOAEL for this effect is 100 mg/kg bw. Based on microscopic evidence of renal and hepatic pathology in males receiving 20 mg/kg/day, the no observed effect level (NOEL)  when administered orally to rats for three months under conditions of this study was 10 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c473603-8a37-4ade-ba1f-561023c67a02/documents/IUC5-3ee0d35f-8bab-48e9-967a-a99bd4805d61_3ccdc27e-1082-4234-a294-070d1fabf65a.html,,,,,, Bis(2-chloroethoxy)methane,111-91-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c473603-8a37-4ade-ba1f-561023c67a02/documents/IUC5-3ee0d35f-8bab-48e9-967a-a99bd4805d61_3ccdc27e-1082-4234-a294-070d1fabf65a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,, Bis(2-chloroethoxy)methane,111-91-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c473603-8a37-4ade-ba1f-561023c67a02/documents/IUC5-3ee0d35f-8bab-48e9-967a-a99bd4805d61_3ccdc27e-1082-4234-a294-070d1fabf65a.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,, Bis(2-chloroethoxy)methane,111-91-1,"The LD50 cut-off of the test item is 200 mg/kg body weight by oral route in the rat. The LD50 is between 50-300 mg/kg bw.The dermal LD50 of the test item was found to be higher than 2000 mg/kg body weight in male and between 1000 mg/kg body weight and 2000 mg/ kg body weight in female CRL:(WI) rats.The inhalatory LC50, 4h value of Diformal in Wistar rats was established to be within the range of 0.05 – 0.5 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c473603-8a37-4ade-ba1f-561023c67a02/documents/IUC5-e9e020e5-0f7a-4c40-802f-3be4962a8c63_3ccdc27e-1082-4234-a294-070d1fabf65a.html,,,,,, "Bis(2-chloroethyl) 3,3'-[(2,5-dimethyl-p-phenylene)bis[iminocarbonyl(2-hydroxy-1,3-naphthylene)azo]]di-p-toluate",68259-05-2,"The substance does not cause treatment-related adverse effects up to the limit dose upon subacute oral exposure (OECD 422, GLP). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29c9bca3-0f10-4768-aed9-1727c2c221ce/documents/3c697502-b028-4fdd-84b8-8a3046d0dfaa_4fa27420-bcdf-42a0-a3cc-913f0fc90a25.html,,,,,, "Bis(2-chloroethyl) 3,3'-[(2,5-dimethyl-p-phenylene)bis[iminocarbonyl(2-hydroxy-1,3-naphthylene)azo]]di-p-toluate",68259-05-2," The substance is non-toxic upon single ingestion in rats (OECD 401, GLP). It is considered to be non-toxic upon a 4h single inhalation based on expertimental data with its structural analogue. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29c9bca3-0f10-4768-aed9-1727c2c221ce/documents/a0d51a9f-4d93-4a7d-8a3d-b3b7b697af47_4fa27420-bcdf-42a0-a3cc-913f0fc90a25.html,,,,,, "Bis(2-chloroethyl) 3,3'-[(2,5-dimethyl-p-phenylene)bis[iminocarbonyl(2-hydroxy-1,3-naphthylene)azo]]di-p-toluate",68259-05-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29c9bca3-0f10-4768-aed9-1727c2c221ce/documents/a0d51a9f-4d93-4a7d-8a3d-b3b7b697af47_4fa27420-bcdf-42a0-a3cc-913f0fc90a25.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bis(2-dimethylaminoethyl)(methyl)amine,3030-47-5,"The value of NOAEL (No Observed Adverse Effect Level) for repeated dose toxicity after oral exposure was established as 30 mg/kg bw/day for the male and female. The value was established from the repeated dose 90-day oral toxicity study mainly on the basis of changes in body weight, clinical signs and mortality (one male at the highest dose).Regarding inhalatory exposure, no systemic effects were revealed, only local irritation, with the local LOAEC of 21.26 mg/m3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2b9506d-e727-4902-9f64-cee876f0de35/documents/IUC5-e205dd62-3177-4f1c-a544-589e63b531aa_387588b4-9e15-42bb-a695-27fe74f306ab.html,,,,,, Bis(2-dimethylaminoethyl)(methyl)amine,3030-47-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2b9506d-e727-4902-9f64-cee876f0de35/documents/IUC5-e205dd62-3177-4f1c-a544-589e63b531aa_387588b4-9e15-42bb-a695-27fe74f306ab.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat Bis(2-dimethylaminoethyl)(methyl)amine,3030-47-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2b9506d-e727-4902-9f64-cee876f0de35/documents/IUC5-e205dd62-3177-4f1c-a544-589e63b531aa_387588b4-9e15-42bb-a695-27fe74f306ab.html,Repeated dose toxicity – local effects,inhalation,LOAEC,21.26 mg/m3,adverse effect observed,rat Bis(2-dimethylaminoethyl)(methyl)amine,3030-47-5,"Acute toxicity oral: study equivalent/similar to OECD Guideline 401, doses: 3200, 1600, 800 and 200 µL/kg bw, rat m/f, 8 days observation, LD50 = 1330 mg /kg bw.Acute toxicity dermal: study equivalent or similar to OECD Guideline 402, doses: 200, 1000 mg/kg bw, Vienna White rabbit m/f, occlusive coverage, LD50>200 mg/kg bw < 1000 mg/kg bw. Acute toxicity ihalalation: study comparable to OECD Guideline 403, doses: 69, 164, 230 or 366 ppm, whole body exposure, rat m/f, LC50 = 2055.5 mg/m3 (2.056 mg/L).Acute toxicity other: intraperitoneal injection, mice m/f, 7 days observation, LD50 = 315 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2b9506d-e727-4902-9f64-cee876f0de35/documents/IUC5-fb6caf45-e3e2-4e9c-a462-cb9f424a679f_387588b4-9e15-42bb-a695-27fe74f306ab.html,,,,,, Bis(2-dimethylaminoethyl)(methyl)amine,3030-47-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2b9506d-e727-4902-9f64-cee876f0de35/documents/IUC5-fb6caf45-e3e2-4e9c-a462-cb9f424a679f_387588b4-9e15-42bb-a695-27fe74f306ab.html,,oral,LD50,"1,330 mg/kg bw",adverse effect observed, Bis(2-dimethylaminoethyl)(methyl)amine,3030-47-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2b9506d-e727-4902-9f64-cee876f0de35/documents/IUC5-fb6caf45-e3e2-4e9c-a462-cb9f424a679f_387588b4-9e15-42bb-a695-27fe74f306ab.html,,dermal,LD50,200 mg/kg bw,adverse effect observed, Bis(2-dimethylaminoethyl)(methyl)amine,3030-47-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2b9506d-e727-4902-9f64-cee876f0de35/documents/IUC5-fb6caf45-e3e2-4e9c-a462-cb9f424a679f_387588b4-9e15-42bb-a695-27fe74f306ab.html,,inhalation,LC50,"2,055.5 mg/m3",adverse effect observed, "Bis(2-ethylhexan-1-olato)bis(pentane-2,4-dionato-O,O')titanium",94233-27-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6ca1d8b-9417-46c2-ac14-685ae7d5848a/documents/4b92d20d-1bc1-47b2-b633-9bfb7a77960b_15f06b1f-2d72-45cd-8740-4e33b826acff.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,244 mg/kg bw/day,,rabbit "Bis(2-ethylhexan-1-olato)bis(pentane-2,4-dionato-O,O')titanium",94233-27-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6ca1d8b-9417-46c2-ac14-685ae7d5848a/documents/4b92d20d-1bc1-47b2-b633-9bfb7a77960b_15f06b1f-2d72-45cd-8740-4e33b826acff.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,417 mg/m3,,rat "Bis(2-ethylhexan-1-olato)bis(pentane-2,4-dionato-O,O')titanium",94233-27-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6ca1d8b-9417-46c2-ac14-685ae7d5848a/documents/4b92d20d-1bc1-47b2-b633-9bfb7a77960b_15f06b1f-2d72-45cd-8740-4e33b826acff.html,Chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Bis(2-ethylhexan-1-olato)bis(pentane-2,4-dionato-O,O')titanium",94233-27-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6ca1d8b-9417-46c2-ac14-685ae7d5848a/documents/a7bc5290-8d86-407d-8a17-386d54d01f52_15f06b1f-2d72-45cd-8740-4e33b826acff.html,,oral,LD50,"2,280 mg/kg bw",no adverse effect observed, "Bis(2-ethylhexan-1-olato)bis(pentane-2,4-dionato-O,O')titanium",94233-27-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6ca1d8b-9417-46c2-ac14-685ae7d5848a/documents/a7bc5290-8d86-407d-8a17-386d54d01f52_15f06b1f-2d72-45cd-8740-4e33b826acff.html,,dermal,LD50,"3,160 mg/kg bw",no adverse effect observed, "Bis(2-ethylhexan-1-olato)bis(pentane-2,4-dionato-O,O')titanium",94233-27-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6ca1d8b-9417-46c2-ac14-685ae7d5848a/documents/a7bc5290-8d86-407d-8a17-386d54d01f52_15f06b1f-2d72-45cd-8740-4e33b826acff.html,,inhalation,LC50,"20,024 mg/m3",no adverse effect observed, "Bis(2-ethylhexyl) 2,2'-thiobisacetate",24293-43-4,"Repeated-dose toxicity testing has not been performed, because no significant exposure occurs in all scenarios of manufacture and identified uses.In a worst case scenario a very conservative oral DNEL based on the TTC concept for chronic toxicity was choosen for Di-2-EHTDG, a Cramer class 1 substance. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/2bf4827b-c8f9-40d1-978b-408f8237d0f0/documents/IUC5-9f5bb5af-3073-4660-bf5f-53db79c8c51d_fe82f1e1-6fa1-4aaa-891a-be76261d2ffa.html,,,,,, "Bis(2-ethylhexyl) 2,2'-thiobisacetate",24293-43-4,"Di-2 -EHTDG is not toxic via the oral and dermal route. The LD50 values are greater than 5000 and 2000 mg/kg bw, respectively.Inhalation is not a relevant route of exposure because of the low vapour pressure and the lack of inhalation exposure via aerosols. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bf4827b-c8f9-40d1-978b-408f8237d0f0/documents/IUC5-10923417-beda-4179-9855-179a292fc820_fe82f1e1-6fa1-4aaa-891a-be76261d2ffa.html,,,,,, "Bis(2-ethylhexyl) 2,2'-thiobisacetate",24293-43-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bf4827b-c8f9-40d1-978b-408f8237d0f0/documents/IUC5-10923417-beda-4179-9855-179a292fc820_fe82f1e1-6fa1-4aaa-891a-be76261d2ffa.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Bis(2-ethylhexyl) 2,2'-thiobisacetate",24293-43-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bf4827b-c8f9-40d1-978b-408f8237d0f0/documents/IUC5-10923417-beda-4179-9855-179a292fc820_fe82f1e1-6fa1-4aaa-891a-be76261d2ffa.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bis(2-ethylhexyl) azelate,103-24-2,"In conclusion, no human hazard for systemic toxicity after repeated oral, dermal, or inhalation exposure was identified for the PFAE linear category members. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fbdacfb-f123-4cd6-ba91-9b50488f6a2e/documents/IUC5-aa8e4203-6a2c-4f6d-8961-1596a6486f1b_a6480417-fd7c-4ade-8839-a109129cffe6.html,,,,,, Bis(2-ethylhexyl) azelate,103-24-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fbdacfb-f123-4cd6-ba91-9b50488f6a2e/documents/IUC5-aa8e4203-6a2c-4f6d-8961-1596a6486f1b_a6480417-fd7c-4ade-8839-a109129cffe6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Bis(2-ethylhexyl) azelate,103-24-2,All available acute oral toxicity studies within this category resulted in acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.7 mg/L. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fbdacfb-f123-4cd6-ba91-9b50488f6a2e/documents/IUC5-c25534be-a32d-45f9-8e64-4b2e303fb506_a6480417-fd7c-4ade-8839-a109129cffe6.html,,,,,, "Bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate",84731-70-4," 28 d oral toxicity NOAEL: 100 mg/kgw bw/d (males), 300 mg/kg bw/d (females) (OECD 422).   90 d oral NOAEL: ≥ 1000 mg/kg bw/d (OECD 408) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2be2a68f-fd72-4c8c-8a25-bd687a249b01/documents/IUC5-fb4ebb88-42e0-42e0-b8cc-7011ff27651b_54664ee3-f7de-41dc-bd8c-3baa98e26b17.html,,,,,, "Bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate",84731-70-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2be2a68f-fd72-4c8c-8a25-bd687a249b01/documents/IUC5-fb4ebb88-42e0-42e0-b8cc-7011ff27651b_54664ee3-f7de-41dc-bd8c-3baa98e26b17.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate",84731-70-4," Acute oral toxicity > 2000 mg/kg bw (OECD 423); acute dermal toxicity > 2000 mg/kg bw (OECD 402), acute inhalation toxicity no data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2be2a68f-fd72-4c8c-8a25-bd687a249b01/documents/IUC5-d388bdc3-ee0f-46fc-88bb-e37b5909434f_54664ee3-f7de-41dc-bd8c-3baa98e26b17.html,,,,,, "Bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate",84731-70-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2be2a68f-fd72-4c8c-8a25-bd687a249b01/documents/IUC5-d388bdc3-ee0f-46fc-88bb-e37b5909434f_54664ee3-f7de-41dc-bd8c-3baa98e26b17.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Bis(2-ethylhexyl) cyclohexane-1,4-dicarboxylate",84731-70-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2be2a68f-fd72-4c8c-8a25-bd687a249b01/documents/IUC5-d388bdc3-ee0f-46fc-88bb-e37b5909434f_54664ee3-f7de-41dc-bd8c-3baa98e26b17.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Bis(2-ethylhexyl) hydrogen phosphate,298-07-7,"Repeated dose toxicity - oral route: Sub-acute NOAEL = 150 mg/kg bw/day (OECD 407, gavage, rats, 2013, Key, rel.1). Sub-chronic NOAEL = 50 mg/kg bw/day - converted from source substance NOEL (OECD 408, gavage, rats, 1984, Key, rel.2). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0624ff3d-ba47-4ca5-9a27-47760ba5cd61/documents/IUC5-52add779-02f2-439a-a404-795ae79a475e_9abcc092-30fb-451b-a907-13554bbade77.html,,,,,, Bis(2-ethylhexyl) hydrogen phosphate,298-07-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0624ff3d-ba47-4ca5-9a27-47760ba5cd61/documents/IUC5-52add779-02f2-439a-a404-795ae79a475e_9abcc092-30fb-451b-a907-13554bbade77.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Bis(2-ethylhexyl) hydrogen phosphate,298-07-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0624ff3d-ba47-4ca5-9a27-47760ba5cd61/documents/IUC5-52add779-02f2-439a-a404-795ae79a475e_9abcc092-30fb-451b-a907-13554bbade77.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Bis(2-ethylhexyl) hydrogen phosphate,298-07-7,Acute oral toxicity: LD50 = 1400 mg/kg Acute dermal toxicity: LD50 > 2000 mg/kg Acute inhalation toxicity: LC50 > 1300 mg/m3 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0624ff3d-ba47-4ca5-9a27-47760ba5cd61/documents/IUC5-338561a0-eee4-4694-a89e-e83e3f00c1aa_9abcc092-30fb-451b-a907-13554bbade77.html,,,,,, Bis(2-ethylhexyl) hydrogen phosphate,298-07-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0624ff3d-ba47-4ca5-9a27-47760ba5cd61/documents/IUC5-338561a0-eee4-4694-a89e-e83e3f00c1aa_9abcc092-30fb-451b-a907-13554bbade77.html,,oral,LD50,"1,400 mg/kg bw",adverse effect observed, Bis(2-ethylhexyl) hydrogen phosphate,298-07-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0624ff3d-ba47-4ca5-9a27-47760ba5cd61/documents/IUC5-338561a0-eee4-4694-a89e-e83e3f00c1aa_9abcc092-30fb-451b-a907-13554bbade77.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Bis(2-ethylhexyl) hydrogen phosphate,298-07-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0624ff3d-ba47-4ca5-9a27-47760ba5cd61/documents/IUC5-338561a0-eee4-4694-a89e-e83e3f00c1aa_9abcc092-30fb-451b-a907-13554bbade77.html,,inhalation,LC50,"> 1,300 mg/m3",no adverse effect observed, Bis(2-ethylhexyl) peroxydicarbonate,16111-62-9, Two repeated dose toxicity studies are available for the target substance. In a subacute 28-day (OECD 407) and in a subchronic 90-day (OECD 408) repeated dose toxicity study in Wistar rats the NOAEL was considered to be in both studies 1000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25c89afd-dde4-4add-bc02-cf0006b6df81/documents/IUC5-651302e7-9cce-4ff2-acbf-b14ab44f4b14_c1ad2666-a3f4-4c26-a4fc-c30ce1df7ef5.html,,,,,, Bis(2-ethylhexyl) peroxydicarbonate,16111-62-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25c89afd-dde4-4add-bc02-cf0006b6df81/documents/IUC5-651302e7-9cce-4ff2-acbf-b14ab44f4b14_c1ad2666-a3f4-4c26-a4fc-c30ce1df7ef5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Bis(2-ethylhexyl) peroxydicarbonate,16111-62-9,"Acute toxicity has been tested in an oral toxicity study according to OECD 423 and a dermal toxicity study comparable to OECD 402, at doses of 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25c89afd-dde4-4add-bc02-cf0006b6df81/documents/IUC5-9c2f491e-89c8-4728-9b71-b69eb80f33b1_c1ad2666-a3f4-4c26-a4fc-c30ce1df7ef5.html,,,,,, Bis(2-ethylhexyl) peroxydicarbonate,16111-62-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25c89afd-dde4-4add-bc02-cf0006b6df81/documents/IUC5-9c2f491e-89c8-4728-9b71-b69eb80f33b1_c1ad2666-a3f4-4c26-a4fc-c30ce1df7ef5.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bis(2-ethylhexyl) peroxydicarbonate,16111-62-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25c89afd-dde4-4add-bc02-cf0006b6df81/documents/IUC5-9c2f491e-89c8-4728-9b71-b69eb80f33b1_c1ad2666-a3f4-4c26-a4fc-c30ce1df7ef5.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bis(2-ethylhexyl) tetrabromophthalate,26040-51-7," In a subacute repeated dose toxicity study according to OECD 407, three groups of ten male and ten female CD rats received FR-45B via the diet at concentrations of 200, 2 000 or 20 000 ppm (= ca. 21.97, 223.4 or 2331 mg/kg/day) for four weeks. A similarly constituted control group received untreated diet. There were no signs of reaction to treatment with FR-45B (bis(2-ethylhexyl) tetrabromophthalate). Slightly low overall bodyweight gain was recorded for females receiving the highest dietary concentration of FR-45B. Males treated with FR-45B were unaffected. Marginally low alanine amino-transferase activities were seen in females receiving the highest dietary concentration of FR-45B, and marginally low phosphorus concentrations were seen in all females and males receiving the highest dietary concentration of FR-45B. Urinary composition was unaffected by treatment with FR-45B. There were no organ weight changes in rats receiving FR-45B.There were no treatment-related histopathological changes in animals that received FR-45B. The NOAEL is 2000 ppm  = ca. 223.4 mg/kg bw (male + female  rats). In a subchronic repeated dose toxicity study according to OECD 408, oral administration of bis(2-ethylhexyl) tetrabromophthalate (CAS No. 26040-51-7) to male and female Wistar Han™:RccHan™:WIST strain rats for ninety consecutive days at dose levels of 100, 300 and 1000 mg/kg bw/day resulted in no treatment related changes.  The No Observed Effect Level (NOEL) is considered to be 1000 mg/kg bw/day, the highest dose tested. The effects observed in the 28 day feeding study were slight (marginally low alanine amino-transferase activities in the highest dietary concentration of FR-45B, and marginally low phosphorus concentrations were seen in all females and males receiving the highest dietary concentration) and are not confirmed in the 90 day gavage study. Therefore the NOAEL of 1000 mg/kg bw/day determined in the 90 day study is used for the derivation of the DNELs because the 90 day study exposed animals longer, used more animals per group, investigated more parameter and is considered more relevant for human risk assessment. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60930694-3eb6-400e-b8ab-6fc23de9ddda/documents/IUC5-d08c21b8-4079-48ff-a2ff-8862dcf3287b_25cb7247-5fb5-4352-b421-31347c1adb02.html,,,,,, Bis(2-ethylhexyl) tetrabromophthalate,26040-51-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60930694-3eb6-400e-b8ab-6fc23de9ddda/documents/IUC5-d08c21b8-4079-48ff-a2ff-8862dcf3287b_25cb7247-5fb5-4352-b421-31347c1adb02.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Bis(2-ethylhexyl) tetrabromophthalate,26040-51-7, A valid acute oral study according OECD 401 (limit test) and dermal toxicity study according OECD 402 is available. No acute inhalation study is on hand. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60930694-3eb6-400e-b8ab-6fc23de9ddda/documents/IUC5-ad75e874-12c0-49b6-8337-845904473870_25cb7247-5fb5-4352-b421-31347c1adb02.html,,,,,, Bis(2-ethylhexyl) tetrabromophthalate,26040-51-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60930694-3eb6-400e-b8ab-6fc23de9ddda/documents/IUC5-ad75e874-12c0-49b6-8337-845904473870_25cb7247-5fb5-4352-b421-31347c1adb02.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Bis(2-ethylhexyl) tetrabromophthalate,26040-51-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60930694-3eb6-400e-b8ab-6fc23de9ddda/documents/IUC5-ad75e874-12c0-49b6-8337-845904473870_25cb7247-5fb5-4352-b421-31347c1adb02.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bis(2-hydroxyethyl) sulphone,2580-77-0," Introduction The study was designed to investigate the systemic toxicity and potential adverse effects of the test item on reproduction (including offspring development) and is designed to be compatible with the requirements of the OECD Guidelines for Testing of Chemicals No. 422 “Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test” (adopted 22 March 1996). This study was also designed to be compatible with Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). Methods The test item was administered by gavage to three groups, each of twelve male and twelve female Wistar Han™:RccHan™:WIST strain rats, for approximately six weeks (including a two week pre-pairing phase, pairing, gestation and early lactation for females), at dose levels of 100, 300 or 1000 mg/kg bw/day. A control group of twelve males and twelve females was dosed with vehicle alone (Distilled water). Clinical signs, behavioral assessments, body weight change and food and water consumption were monitored during the study. Pairing of animals within each dose group was undertaken on a one male: one female basis within each treatment group on Day 15 of the study, with females subsequently being allowed to litter and rear their offspring to Day 5 of lactation. During the lactation phase, daily clinical observations were performed on all surviving offspring, together with litter size and offspring weights and assessment of surface righting reflex. Extensive functional observations were performed on five selected males from each dose group after the completion of the pairing phase, and for five selected parental females from each dose group on Day 4 post partum. Hematology and blood chemistry were evaluated prior to termination on five selected males and females from each dose group. Adult males were terminated on Day 43 or 44 of the study, followed by the termination of all females and surviving offspring on Day 5 post partum. All animals were subjected to a gross necropsy examination and histopathological evaluation of selected tissues from control and 1000 mg/kg bw/day dose groups was performed. Results Mortality: There were no unscheduled deaths during the study. Clinical Observations: Throughout the study, there were no clinical signs considered to be related to treatment with the test item. Behavioral Assessment: There were no treatment-related changes in the behavioral parameters measured. Functional Performance Tests: There was no effect of treatment with the test item at any dose level on functional performance in animals of either sex. Sensory Reactivity Assessments: Sensory reactivity scores across all test item-treated dose groups were similar to controls. Body Weight: There was no adverse effect of treatment with the test item on body weight development for animals of either sex during the dose administration period. Food Consumption: There was no adverse effect of treatment with the test item on food consumption or food conversion efficiency for animals of either sex during the treatment period. Water Consumption: Visual inspection of water bottles did not indicate any overt differences for the animals given the test item in comparison with controls. Reproductive Performance: Mating: There was no effect of treatment on mating performance. All animals mated within four days after pairing. Fertility: There were no treatment-related effects in conception rates for test item-treated animals in relation to controls. All females were pregnant. Gestation Lengths: There were no differences in gestation lengths in animals receiving the test item when compared with controls. Litter Responses: Offspring Litter Size, Sex Ratio and Viability: There was no detrimental effect of treatment with the test item on corpora lutea count, pre-implantation loss, number of implantations, post-implantation loss, litter size, sex ratio and subsequent offspring survival to Day 5 of age at 100, 300 or 1000 mg/kg bw/day. Offspring Growth and Development: There was no detrimental effect of treatment with the test idicated by offspring body weight or body weight gan and litter weights, surface righting ability on Day 1 or clinical signs up to Day 5 of age at 100, 300 or 1000 mg/kg bw/day. Laboratory Investigations: Hematology: No toxicologically significant effects were detected in animals of either sex at any dose level. Blood Chemistry: No toxicologically significant effects were detected in animals of either sex at any dose level. Pathology: Necropsy: Neither the type, incidence or distribution of macroscopic observations in adult animals or offspring indicated any treatment-related effect of treatment up to a dose level of 1000 mg/kg bw/day. Organ Weights: No toxicologically significant effects were detected in animals of either sex at any dose level. Histopathology: Histopathological examination of the selected tissues from the 1000 mg/kg bw/day animals of either sex did not reveal any treatment-related abnormalities. Conclusion The oral (gavage) administration of BHES to Wistar Han™:RccHan™:WIST strain rats, at dose levels of 100, 300 or 1000 mg/kg bw/day was well tolerated. Based on the available results, the ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was considered to be 1000 mg/kg bw/day within the confines of this study. Additionally, the 'No Observed Effect Level' (NOEL) for reproductive toxicity was considered to be 1000 mg/kg bw/day within the confines of this study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2dc5297-85d0-43ef-a81a-6b2b1a999bd7/documents/37cbe841-4842-4418-964b-52360a01ce5d_78d64f65-6b28-4023-b77b-915c12d5ab15.html,,,,,, Bis(2-hydroxyethyl) sulphone,2580-77-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2dc5297-85d0-43ef-a81a-6b2b1a999bd7/documents/37cbe841-4842-4418-964b-52360a01ce5d_78d64f65-6b28-4023-b77b-915c12d5ab15.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Bis(2-hydroxyethyl) sulphone,2580-77-0," Acute oral toxicity: Introduction. The study was performed to assess the acute oral toxicity of the test material following a single oral administration in the Sprague-Dawley CD strain rat. The method was designed to meet the requirements of the following: • OECD Guidelines for the Testing of Chemicals No. 423 ""Acute Oral Toxicity- Acute Toxic Class Method"" (adopted 1 7 December 2001) • Method B1 tris Acute Toxicity (Oral) of Commission Directive 2004/73/EC Method. A group of three fasted females was treated with the test material at a dose level of 2000 mg/kg bodyweight. This was followed by a further group of three fasted females at the same dose level. The test material was administered orally as a solution in distilled water. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. Mortality: There were no deaths. Clinical Observations: There were no signs of systemic toxicity. Bodyweight: All animals showed expected gains in bodyweight over the study period. Necropsy: No abnormalities were noted at necropsy. Conclusion. The acute oral median lethal dose (LDso) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2500 mg/kg bodyweight (Globally Harmonised Classification System - Unclassified). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2dc5297-85d0-43ef-a81a-6b2b1a999bd7/documents/59a8ccfe-b31a-4040-9fd5-19e8ad1ca865_78d64f65-6b28-4023-b77b-915c12d5ab15.html,,,,,, Bis(2-hydroxyethyl) sulphone,2580-77-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2dc5297-85d0-43ef-a81a-6b2b1a999bd7/documents/59a8ccfe-b31a-4040-9fd5-19e8ad1ca865_78d64f65-6b28-4023-b77b-915c12d5ab15.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Bis(2-hydroxyethyl)ammonium acetate,23251-72-1,"No relevant data are available on DEA acetate, but reliable 28-day oral gavage studies have been carried out on structurally-related read-across compounds. NOAELs of 150 and 1000 mg/kg bw/day were reported for RA1 and RA2, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62cccabc-1abf-41f3-9bfd-f66dc27856aa/documents/IUC5-ca5ab84a-8b35-42c1-b04b-1d22881a4a5f_684ff13e-9b0b-4c07-a622-b5e1093d8b36.html,,,,,, Bis(2-hydroxyethyl)ammonium acetate,23251-72-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62cccabc-1abf-41f3-9bfd-f66dc27856aa/documents/IUC5-ca5ab84a-8b35-42c1-b04b-1d22881a4a5f_684ff13e-9b0b-4c07-a622-b5e1093d8b36.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Bis(2-hydroxyethyl)ammonium acetate,23251-72-1,"Studies on DEA acetate were not available, but laboratory animals have been tested with both RA1 and RA2 via the oral and dermal routes. Acute oral LD50 values of 7500 mg/kg bw and over 2000 mg/kg bw were reported for RA2 and RA1, respectively, in rats. Dermal LD50 values in excess of 2000 mg/kg bw were reported for RA1 (in rats) and RA2 (in rabbits). Inhalation exposure is not expected. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62cccabc-1abf-41f3-9bfd-f66dc27856aa/documents/IUC5-a1390daa-767c-406d-b2c8-5e97794cc727_684ff13e-9b0b-4c07-a622-b5e1093d8b36.html,,,,,, Bis(2-hydroxyethyl)ammonium acetate,23251-72-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62cccabc-1abf-41f3-9bfd-f66dc27856aa/documents/IUC5-a1390daa-767c-406d-b2c8-5e97794cc727_684ff13e-9b0b-4c07-a622-b5e1093d8b36.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Bis(2-hydroxyethyl)ammonium acetate,23251-72-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62cccabc-1abf-41f3-9bfd-f66dc27856aa/documents/IUC5-a1390daa-767c-406d-b2c8-5e97794cc727_684ff13e-9b0b-4c07-a622-b5e1093d8b36.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Bis(2-methylisouronium) sulphate,52328-05-9," O-Methylisourea sulphate was administred with feed to male and female albino rats. General conditions, behaviour and survival were not adversly affected by the feeding of the test substance Body weights, food intake and food efficiency were decreased at the 1.5% level in both exes. No distinct differences in haemoglobin content werde observed between the various groups Gross examination at autopsy and histological examination of liver, kidneys andspleen did not reveal any treatment-related abnormaities. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4cf0199-a7d9-4d64-9963-2bea39def0c9/documents/IUC5-76a2172f-fb92-4b05-ba6b-62d1408ff599_f560e1ca-3874-45e3-86cf-ccd000b53dd2.html,,,,,, Bis(2-methylisouronium) sulphate,52328-05-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4cf0199-a7d9-4d64-9963-2bea39def0c9/documents/IUC5-76a2172f-fb92-4b05-ba6b-62d1408ff599_f560e1ca-3874-45e3-86cf-ccd000b53dd2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,510 mg/kg bw/day,,rat Bis(2-methylisouronium) sulphate,52328-05-9, From the mortality figures the LD50 of O-Methylisourea sulphate was calculated to be 3.7 g/kg body weight. Within one hour after dosing most of the rats showed diarrhoea and decreased activity. In the three highest doses groups some rats had signs of unconsciousness. Deaths occurred within 24 hours. No delayed deaths were observed. At the end of the observation period the surviving animals looked quite healthy again. No treatment-related gross changes were seen at autopsy at day 14. Exposure to O-Methylisourea sulfate techical at a single chamber concentration of 2.133 mg/L did not cause mortality. Minor signs of toxicity such as changes in clinical condition and a small reduction in body weight gain were considered not to be significant signs of toxicity. Using standard toxicity assessment criteria the test article can be classified as non-toxic or slightly toxic. As the maximum practical concentration used produced only slight signs of toxicity the test article is of low acute toxicity and should probably be classified as non-toxic. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4cf0199-a7d9-4d64-9963-2bea39def0c9/documents/IUC5-c580fbd8-dfb2-42c8-bbc4-b7f22d50998d_f560e1ca-3874-45e3-86cf-ccd000b53dd2.html,,,,,, Bis(2-methylisouronium) sulphate,52328-05-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4cf0199-a7d9-4d64-9963-2bea39def0c9/documents/IUC5-c580fbd8-dfb2-42c8-bbc4-b7f22d50998d_f560e1ca-3874-45e3-86cf-ccd000b53dd2.html,,oral,LD50,"3,700 mg/kg bw",adverse effect observed, bis(2-methylpropyl) perylene-dicarboxylate,79869-59-3," LD50 oral, rat > 10000 mg/kg LD50 i.p., mice > 6810 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a759e563-fbd4-4de6-bdd2-149a405e0dfe/documents/49a71cc3-86b4-41c4-bf76-e3700f1fad2d_6889cabe-3c49-4494-a505-8995c022be32.html,,,,,, bis(2-methylpropyl) perylene-dicarboxylate,79869-59-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a759e563-fbd4-4de6-bdd2-149a405e0dfe/documents/49a71cc3-86b4-41c4-bf76-e3700f1fad2d_6889cabe-3c49-4494-a505-8995c022be32.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, bis(2-methylpropyl) perylene-dicarboxylate,79869-59-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a759e563-fbd4-4de6-bdd2-149a405e0dfe/documents/49a71cc3-86b4-41c4-bf76-e3700f1fad2d_6889cabe-3c49-4494-a505-8995c022be32.html,,inhalation,LC50,4 mg/m3,no adverse effect observed, Bis(2-propylheptyl) phthalate,53306-54-0,Repeated dose toxicity:- oral: NOAEL 1 = 40 mg/kg bw/d (OECD 408) for liver effects - indicative for peroxisomal proliferation- oral: NOAEL 2 = 196 mg/kg bw/d (OECD 408) for hematological effects relevant for human hazard- by inhalation: NOAEC systemic: 250 mg/m3 for effects in clinical chemistry parameter- by inhalation: NOAEC local: 50 mg/m3 for several lesions in lung and nasal cavity ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00ecebfb-264b-4fb1-9c6d-0bfe65d09c9d/documents/IUC5-b2f7d577-32bc-4d9f-9bb9-a9e15279d866_49c24fb5-ba26-495f-8654-787d1e4a36c9.html,,,,,, Bis(2-propylheptyl) phthalate,53306-54-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00ecebfb-264b-4fb1-9c6d-0bfe65d09c9d/documents/IUC5-b2f7d577-32bc-4d9f-9bb9-a9e15279d866_49c24fb5-ba26-495f-8654-787d1e4a36c9.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,250 mg/m3,,rat Bis(2-propylheptyl) phthalate,53306-54-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00ecebfb-264b-4fb1-9c6d-0bfe65d09c9d/documents/IUC5-b2f7d577-32bc-4d9f-9bb9-a9e15279d866_49c24fb5-ba26-495f-8654-787d1e4a36c9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,196 mg/kg bw/day,,rat Bis(2-propylheptyl) phthalate,53306-54-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00ecebfb-264b-4fb1-9c6d-0bfe65d09c9d/documents/IUC5-b2f7d577-32bc-4d9f-9bb9-a9e15279d866_49c24fb5-ba26-495f-8654-787d1e4a36c9.html,Repeated dose toxicity – local effects,inhalation,NOAEC,50 mg/m3,adverse effect observed,rat Bis(2-propylheptyl) phthalate,53306-54-0,Acute toxicity:- oral: LD50 > 5000 mg/kg bw- dermal: LD50 > 2000 mg/kg bw- inhalative: LC50 > 5 mg/L air (4 h exposure) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00ecebfb-264b-4fb1-9c6d-0bfe65d09c9d/documents/IUC5-b2eea3d6-b31d-4516-86fc-53a62ee686b4_49c24fb5-ba26-495f-8654-787d1e4a36c9.html,,,,,, Bis(2-propylheptyl) phthalate,53306-54-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00ecebfb-264b-4fb1-9c6d-0bfe65d09c9d/documents/IUC5-b2eea3d6-b31d-4516-86fc-53a62ee686b4_49c24fb5-ba26-495f-8654-787d1e4a36c9.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Bis(2-propylheptyl) phthalate,53306-54-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00ecebfb-264b-4fb1-9c6d-0bfe65d09c9d/documents/IUC5-b2eea3d6-b31d-4516-86fc-53a62ee686b4_49c24fb5-ba26-495f-8654-787d1e4a36c9.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bis(2-propylheptyl) phthalate,53306-54-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00ecebfb-264b-4fb1-9c6d-0bfe65d09c9d/documents/IUC5-b2eea3d6-b31d-4516-86fc-53a62ee686b4_49c24fb5-ba26-495f-8654-787d1e4a36c9.html,,inhalation,discriminating conc.,"5,000 mg/m3",no adverse effect observed, "Bis(3,5,5-trimethylhexanoyl) peroxide",3851-87-4," Two repeated dose toxicity studies are available for the target substance. In a subactue 28-day study in Wistar rats (OECD 407), the NOAEL was determined to be 300 mg/kg bw/day. In a subchronic 90 -day repeated dose study (OECD 408) in Wistar rats, a NOAEL of 1000 mg/kg bw/day was established for females, while a LOAEL of 100 mg/kg bw/day was determined for males due to tubular cell necrosis. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f159ae54-6ce9-4579-aa62-58ce9bccbcad/documents/IUC5-90d66f03-927e-44fd-b5a7-13e602b09695_52545fdd-0e48-4b6f-a484-c646d0d872fb.html,,,,,, "Bis(3,5,5-trimethylhexanoyl) peroxide",3851-87-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f159ae54-6ce9-4579-aa62-58ce9bccbcad/documents/IUC5-90d66f03-927e-44fd-b5a7-13e602b09695_52545fdd-0e48-4b6f-a484-c646d0d872fb.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat "Bis(3,5,5-trimethylhexanoyl) peroxide",3851-87-4,Acute oral toxicity was assessed in a non GLP study equivalent to OECD 401. Acute dermal toxicity was assessed in a GLP guideline study according to OECD 402yt ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f159ae54-6ce9-4579-aa62-58ce9bccbcad/documents/IUC5-6f0b8893-3d87-4da2-9a64-3146110a77b1_52545fdd-0e48-4b6f-a484-c646d0d872fb.html,,,,,, "Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine",15721-78-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): One key study is available to address the endpoint, with a Klimisch score of 1, performed to standardised guidelines under GLP conditions. Therefore, the quality of the database is considered to be good. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8579e130-11da-4de5-88dc-6bd4e806a852/documents/IUC5-0ba4bcd7-7b08-4415-8c98-b4f5f6716490_7942a2a3-2c2d-4040-b0d7-4696be42d284.html,,,,,, "Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine",15721-78-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8579e130-11da-4de5-88dc-6bd4e806a852/documents/IUC5-0ba4bcd7-7b08-4415-8c98-b4f5f6716490_7942a2a3-2c2d-4040-b0d7-4696be42d284.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine",15721-78-5,"Oral route:The LD50 of Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is greater than 5000 mg/kg (Biosearch, 1979). Inhalation route:The LD50 of bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is greater than 5.8 mg/l (Biosearch, 1979). Dermal route:Dermal exposure to bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine is considered unlikely, therefore, this endpoint is waived. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8579e130-11da-4de5-88dc-6bd4e806a852/documents/IUC5-7c3d8073-4bab-4026-891b-24718af96076_7942a2a3-2c2d-4040-b0d7-4696be42d284.html,,,,,, "Bis(4-(1,1,3,3-tetramethylbutyl)phenyl)amine",15721-78-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8579e130-11da-4de5-88dc-6bd4e806a852/documents/IUC5-7c3d8073-4bab-4026-891b-24718af96076_7942a2a3-2c2d-4040-b0d7-4696be42d284.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Bis(4-(1,2-bis(ethoxycarbonyl)ethylamino)-3-methylcyclohexyl)methane",136210-32-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A short term oral toxicity study (28-days; Bomhard, Bayer AG, 1992b) of the substance revealed no toxicological effects. The derived NOAEL was 1000 mg/kg bw/day. In a two-generation reproductive toxicity study mild kidney effects (basophilic tubules and focal tubular dilation/hyaline casts) were seen in males only at a dose of 1000 mg/kg bw/day. The basophilic tubules and focal tubular dilation/hyaline casts are common spontaneous findings in male rats of this age but as a worst case assumption these findings were concluded to be adverse, since they correlated with statistically significantly elevated absolute and/or relative kidney weights, evident for F0 and F1 rats at 1000 mg/kg. Thus, 1000 mg/kg turned out to be a LOAEL and 200 mg/kg a NOAEL in the study based on such kidney responses. It is not expected that a 90-days repeated dose toxicity study according to OECD TG 408 would substantially change the assessment of the substance, therefore the available information on repeated dose toxicity meets the tonnage driven data requirement of REACH. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0224ebdb-f2f6-4b36-b33f-7deda2e391d7/documents/IUC5-38979927-6b33-4081-9d08-f628f6992d95_88636525-e12e-4904-9aeb-323961dcf8c5.html,,,,,, "Bis(4-(1,2-bis(ethoxycarbonyl)ethylamino)-3-methylcyclohexyl)methane",136210-32-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0224ebdb-f2f6-4b36-b33f-7deda2e391d7/documents/IUC5-38979927-6b33-4081-9d08-f628f6992d95_88636525-e12e-4904-9aeb-323961dcf8c5.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,"1,000 mg/kg bw/day",,rat "Bis(4-(1,2-bis(ethoxycarbonyl)ethylamino)-3-methylcyclohexyl)methane",136210-32-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0224ebdb-f2f6-4b36-b33f-7deda2e391d7/documents/IUC5-f562cf80-410a-4f3a-9d70-ee1ebf12457f_88636525-e12e-4904-9aeb-323961dcf8c5.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Bis(4-(1,2-bis(ethoxycarbonyl)ethylamino)-3-methylcyclohexyl)methane",136210-32-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0224ebdb-f2f6-4b36-b33f-7deda2e391d7/documents/IUC5-f562cf80-410a-4f3a-9d70-ee1ebf12457f_88636525-e12e-4904-9aeb-323961dcf8c5.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Bis(4-(1,2-bis(ethoxycarbonyl)ethylamino)-3-methylcyclohexyl)methane",136210-32-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0224ebdb-f2f6-4b36-b33f-7deda2e391d7/documents/IUC5-f562cf80-410a-4f3a-9d70-ee1ebf12457f_88636525-e12e-4904-9aeb-323961dcf8c5.html,,inhalation,discriminating conc.,"4,224 mg/m3",no adverse effect observed, Bis(4-chlorophenyl) sulphone,80-07-9,"In the repeated dose key studies, subchronic oral exposure to DCDPS resulted in centrilobular hepatocyte hypertrophy associated with increased liver weight in both rats and mice (NIH, 2001). Based on these changes, the NOEL was considered to be 2 mg/kg bw/day for rats and 3.5 mg/kg bw/day for mice. Adverse liver effects were observed in male mice from a dose level of 165 mg/kg bw (NOAEL 50 mg/kg bw). While treatment related nephropathy was noted in rats at higher dose levels, no adverse effect on the kidneys was observed in mice. This general pattern of treatment related effects derived from the subchronic key studies was confirmed by supporting information (NIH, 2001; Poon et al., 1999) and a NOEL of 1.5 mg/kg bw was determined in rats. However, with regard to nephropathy in rats, a moderate increase in relative kidney weight was noted after subacute exposure while no relevant change was observed after chronic exposure to DCDPS. Due to the physico chemical properties and the resulting toxicokinetic behaviour of DCDPS, repeated dose toxicity studies for the dermal and inhalation route are not expected to result in a substantially different systemic toxicity. With respect to animal welfare additional subchronic studies for both exposure routes are therefore not required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbda3fcc-3f3d-4c00-8249-978a491f8b78/documents/IUC5-b31b8586-3d6a-4814-bf11-d50e17ec6a81_4031874c-7069-4b85-be2a-0fb919d239a3.html,,,,,, Bis(4-chlorophenyl) sulphone,80-07-9,DCDPS is not acute toxic. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbda3fcc-3f3d-4c00-8249-978a491f8b78/documents/IUC5-8502b03e-441c-4b49-8bc3-9533cc38c85d_4031874c-7069-4b85-be2a-0fb919d239a3.html,,,,,, Bis(4-chlorophenyl) sulphone,80-07-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbda3fcc-3f3d-4c00-8249-978a491f8b78/documents/IUC5-8502b03e-441c-4b49-8bc3-9533cc38c85d_4031874c-7069-4b85-be2a-0fb919d239a3.html,,oral,LD50,"4,810 mg/kg bw",, Bis(4-chlorophenyl) sulphone,80-07-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbda3fcc-3f3d-4c00-8249-978a491f8b78/documents/IUC5-8502b03e-441c-4b49-8bc3-9533cc38c85d_4031874c-7069-4b85-be2a-0fb919d239a3.html,,dermal,LD50,"10,000 mg/kg bw",, Bis(4-fluorophenyl) ketone,345-92-6,No repeated dose toxicity studies are available for bis(4-fluorophenyl) ketone. A data waiver is claimed. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c11fb79e-4f71-4642-acbd-4544f335f6b2/documents/883050b6-f8c9-4289-a4b9-f10e060d4ebe_6978ccae-a354-4fab-b5dc-d20c71c11719.html,,,,,, Bis(4-fluorophenyl) ketone,345-92-6,"Bis(4-fluorophenyl) ketone is of low dermal and inhalative acute toxicity with a dermal LD50 (rat) of > 2500 mg/kg bw (Qing_2006) and an inhalative LC50 (rat, aerosol, 4 hrs) of > 5050 mg/m3 (Zhang_2006). The LD50 value (oral) of bis(4-fluorophenyl) ketone in female and male rats was estimated to be 2000 mg/kg bw (Qing_2006). Therefore, under the conditions of the study the acute toxicity of the test substance after oral exposure in rats is moderate and bis(4-fluorophenyl) ketone has to be classified as harmful if swallowed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c11fb79e-4f71-4642-acbd-4544f335f6b2/documents/b3eb8d54-41d6-49fe-9cf5-c083569f62ee_6978ccae-a354-4fab-b5dc-d20c71c11719.html,,,,,, Bis(4-hydroxy-N-methylanilinium) sulphate,55-55-0," Repeated dose toxicity: Oral Based on the prediction done (SSS Nagpur, 2017) using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound N-methyl-p-aminophenol sulfate. The study assumed the use of male and female Wistar rats in a subchronic study of 3 months. No significant alterations were noted at the dose level of 56.916667938 mg/kg bw/day and thus the predicted NOAEL for N-methyl-p-aminophenol sulfate is considered to be 56.916667938 mg/kg bw/day. Repeated dose toxicity: Inhalation N-Methyl-p-aminophenol has very low vapor pressure (0.000000536 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Repeated dose toxicity: Dermal A repeated dose dermal toxicity study was performed to determine the dermal toxic nature of N-methyl-p-aminophenol sulfate. The study was performed on female Charles River CD rats, where 2 ml/kg dye formulation 7404 or P-26 containing 1% and 0.05% N-methyl-p-aminophenol sulfate, respectively, was applied to the dorso-scapular area. These dye formulations contained other active ingredients in an aqueous solution and were mixed with an equal volume of 6% hydrogen peroxide prior to application. The application was made during the gestation days 1, 4, 7, 10, 13, 16 and 19. The animals were observed for clinical signs, body weight changes, dermal irritation if any and food consumption. No dye formulation related toxicity was noted. Changes in female body weights and food consumption were similar for rats in the untreated controls and all dye-treated groups. No irritation or other changes in appearance were noted except for changes in skin and hair color at the site of topical application of the dye formulation. Based on the observations made, NOAEL for N-methyl-p-aminophenol sulfate in female Charles River CD rats was considered to be 11.47 mg/kg for formulation 7404 and 0.5735 mg/kg for formulation P26, where both formulations contain the target compound. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6432feff-9951-4738-ab10-4cf629da42c3/documents/8bac84da-9640-46ca-b149-4faf0d896602_980a68b0-3fc7-4871-8301-201ad9670ef0.html,,,,,, Bis(4-hydroxy-N-methylanilinium) sulphate,55-55-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6432feff-9951-4738-ab10-4cf629da42c3/documents/8bac84da-9640-46ca-b149-4faf0d896602_980a68b0-3fc7-4871-8301-201ad9670ef0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,56.917 mg/kg bw/day,,rat Bis(4-hydroxy-N-methylanilinium) sulphate,55-55-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6432feff-9951-4738-ab10-4cf629da42c3/documents/8bac84da-9640-46ca-b149-4faf0d896602_980a68b0-3fc7-4871-8301-201ad9670ef0.html,Chronic toxicity – systemic effects,dermal,NOAEL,11.47 mg/kg bw/day,,rat Bis(4-hydroxy-N-methylanilinium) sulphate,55-55-0," Acute oral toxicity LD50 was estimated to be 1578.59 mg/kg bw, when male and female Sprague-Dawley rats were exposed with p-Methylaminophenol sulfate (55-55-0) orally. Acute inhalation toxicity N-methyl-p-aminophenol has very low vapor pressure (0.000000536 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver Acute dermal toxicity LD50 was estimated to be 7087.20mg/kg bw. When male and female New Zealand White rabbits were exposed with p-Methylaminophenol sulfate (55-55-0) by dermal application. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6432feff-9951-4738-ab10-4cf629da42c3/documents/9b7784f3-b922-4981-be24-ad3c2e5f5284_980a68b0-3fc7-4871-8301-201ad9670ef0.html,,,,,, Bis(4-hydroxy-N-methylanilinium) sulphate,55-55-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6432feff-9951-4738-ab10-4cf629da42c3/documents/9b7784f3-b922-4981-be24-ad3c2e5f5284_980a68b0-3fc7-4871-8301-201ad9670ef0.html,,oral,LD50,"1,578.59 mg/kg bw",adverse effect observed, Bis(4-hydroxy-N-methylanilinium) sulphate,55-55-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6432feff-9951-4738-ab10-4cf629da42c3/documents/9b7784f3-b922-4981-be24-ad3c2e5f5284_980a68b0-3fc7-4871-8301-201ad9670ef0.html,,dermal,LD50,"7,087.2 mg/kg bw",no adverse effect observed, Bis(4-methylbenzoyl)peroxide,895-85-2,"In this subacute 28-day oral toxicity study by Hoff (1992), Di-(4-Methylbenzoyl)-peroxid (INTEROX-PMBP) was administered daily by oral gavage to SPF-bred Wistar rats. The test article, prepared in PEG 400, was administered to 7-week old rats [(HanIbm: WIST (SPF)] of both sexes (5 each) for 28 days at doses of 0 (vehicle only), 50, 200 and 1000 mg/kg body weight. There were no toxicologically or statistically significant treatment-related effects on absolute or relative food consumption, body weights, ophthalmology, hematological, clinical biochemical and urinalysis parameters, absolute or relative organ weight, macroscopic or microscopic findings. No repeated dose inhalation or dermal toxicity studies are available. Based upon the 28-day oral toxicity results, the ""no-adverse-effect-level"" of Di-(4 -Methylbenzoyl)-peroxid (INTEROX-PMBP) is 1000 mg/kg body weight for male and female rats when administered orally by gavage for a period of 28 days. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e186103d-a20f-4b2f-b917-0800d2fc3939/documents/IUC5-4542cc2f-6131-4d67-b61a-f7364f57669e_0a4beb50-7894-4faf-baf0-b3ad3887612d.html,,,,,, Bis(4-methylbenzoyl)peroxide,895-85-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e186103d-a20f-4b2f-b917-0800d2fc3939/documents/IUC5-4542cc2f-6131-4d67-b61a-f7364f57669e_0a4beb50-7894-4faf-baf0-b3ad3887612d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Bis(4-methylbenzoyl)peroxide,895-85-2,"The acute ORAL study by Hoff (1991) assessed the toxicological profile of Di-(4 -Methylbenzoyl)-peroxid (INTEROX-PMBP) when administered by a single dose with an observation period of 15 days. The test article was administered to 8 -10 week old rats [(HanIbm: WIST (SPF)] of both sexes (five each) by oral gavage, at 2000 mg/kg, prepared in PEG 400. The death rate was: 0 % at 2000 mg/kg. The LOGIT-Model could not be applied to these data. It was concluded that the acute oral toxicity of Di-(4-Methylbenzoyl)-peroxid (INTEROX-PMBP) in rats of both sexes was estimated to be greater than 2000 mg/kg. An acute DERMAL toxicity study by Hoff (1991) assessed the toxicological profile of Di-(4-Methylbenzoyl)-peroxid (INTEROX-PMBP) when administered to rats by a single semiocclusive dermal application to 10-12 week old rats [(HanIbm: WIST (SPF)] of both sexes (five each) for 24 hours at 2000 mg/kg, prepared in PEG 400. Rats were observed for 15 days. The death rate was 0 % at 2000 mg/kg. Based on these observations, the LOGIT-Model could not be applied to the observed rate of death. Therefore, the toxicity of Di-(4-Methylbenzoyl)-peroxid (INTEROX-PMBP) was estimated to be greater than 2000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e186103d-a20f-4b2f-b917-0800d2fc3939/documents/IUC5-f1be5b05-cec7-4416-88c9-3464ffef3b3c_0a4beb50-7894-4faf-baf0-b3ad3887612d.html,,,,,, Bis(4-methylbenzoyl)peroxide,895-85-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e186103d-a20f-4b2f-b917-0800d2fc3939/documents/IUC5-f1be5b05-cec7-4416-88c9-3464ffef3b3c_0a4beb50-7894-4faf-baf0-b3ad3887612d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bis(4-methylbenzoyl)peroxide,895-85-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e186103d-a20f-4b2f-b917-0800d2fc3939/documents/IUC5-f1be5b05-cec7-4416-88c9-3464ffef3b3c_0a4beb50-7894-4faf-baf0-b3ad3887612d.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bis(C12-C13)alkyl-2-hydroxybutandioate,149144-85-4,"In experimental conditions, on the basis of a total evaluation of the results obtained, the test material bis(C12-C13)alkyl-2-hydroxybutandioate did not cause any local or general toxicity after subacute dermal exposition (28 d) in rabbits. The NOAEL was determined to be 10 mL/kg bw/day (1000 mg/kg bw/d). The inhalative study is waived because the substance has a veryl low vapour pressure (0.0000000026 Pa at 25 °C), so the potential for the generation of inhalable forms is low.The most critical NOAEL for the read-across substance di-2 -ethylhexyl adipate (please see 7.1.1) was observed in the one-generation study (170 mg/kg bw/day - effects on the offspring: reduced total litter weight and reduced mean litter size). At the same time, this is the lowest NOAEL determined in repeated dose toxicity studies. This value will be taken for derivation of the DNELs for bis(C12-C13)alkyl-2-hydroxybutandioate.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a43198f-cbda-47c9-b0c3-44a7f55f3dd7/documents/IUC5-bfced73b-a801-4f95-8483-60d7243ff5a1_b6c36458-0096-43b1-bc7d-db2995c9286f.html,,,,,, Bis(C12-C13)alkyl-2-hydroxybutandioate,149144-85-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a43198f-cbda-47c9-b0c3-44a7f55f3dd7/documents/IUC5-bfced73b-a801-4f95-8483-60d7243ff5a1_b6c36458-0096-43b1-bc7d-db2995c9286f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,170 mg/kg bw/day,,rat Bis(C12-C13)alkyl-2-hydroxybutandioate,149144-85-4,"oral LD50 > 5000 mg/kg bwdermal LD50 > 2000 mg/kg bwThe substance has very low vapour pressure (0.0000000026 Pa at 25 °C), so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. Furthermore the results of laboratory animal studies show low acute oral and dermal toxicity for the substance. This intrinsic property/toxicity potential can be extrapolated to acute inhalative route administration. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a43198f-cbda-47c9-b0c3-44a7f55f3dd7/documents/IUC5-a8fc2dc1-e495-4f37-b11d-52f4b5c3f0b9_b6c36458-0096-43b1-bc7d-db2995c9286f.html,,,,,, "Bis(dibutyldithiocarbamato-S,S')copper",13927-71-4,"28 and 90-day repeated dose toxicity studies are available on the registered substance via the oral route. In both studies, the NOAEL was set at the highest concentration investigated, i.e. 1000 mg/kg bw/day. There is no experimental data available on the inhalation and dermal routes of exposure, as they were not identified as appropriate route of exposure in accordance with Annexes VIII and IX of REACH, taking into account the uses and physicochemical properties of the substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): It is a reliable study with a klimisch score of 1. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d707d94-6499-4005-92be-5a17dadf3a92/documents/IUC5-385d6038-e6e5-4426-9a95-d4ed4b450a67_cbaa486e-e64d-4d50-b4f7-cc31d4a38162.html,,,,,, "Bis(dibutyldithiocarbamato-S,S')copper",13927-71-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d707d94-6499-4005-92be-5a17dadf3a92/documents/IUC5-385d6038-e6e5-4426-9a95-d4ed4b450a67_cbaa486e-e64d-4d50-b4f7-cc31d4a38162.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Bis(dibutyldithiocarbamato-S,S')copper",13927-71-4,"A study was available for the acute oral toxicity in rats on CDBC: the oral LD50 is higher than 2000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): It is a reliable study with a klimisch score of 1 (OECD guideline). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d707d94-6499-4005-92be-5a17dadf3a92/documents/IUC5-c883d6d8-b293-4e06-9d9f-fa4333c43fbd_cbaa486e-e64d-4d50-b4f7-cc31d4a38162.html,,,,,, "Bis(dibutyldithiocarbamato-S,S')copper",13927-71-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d707d94-6499-4005-92be-5a17dadf3a92/documents/IUC5-c883d6d8-b293-4e06-9d9f-fa4333c43fbd_cbaa486e-e64d-4d50-b4f7-cc31d4a38162.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Bis(dodecylthio)dimethylstannane,51287-84-4, Read-across to structurally similar substance DMTE (Dimethyltin bis (2-ethylhexyl thioglycolate) CAS 57583-35-4) Acute oral LD50 1150 mg/kg bw in rats (OECD 401) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/febb264d-6e2d-44e6-a808-b6410966dd1f/documents/2997b98d-322f-44cc-8467-fa2d029cfb61_fa216aee-1e43-4032-8c25-a863be919af5.html,,,,,, Bis(dodecylthio)dimethylstannane,51287-84-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/febb264d-6e2d-44e6-a808-b6410966dd1f/documents/2997b98d-322f-44cc-8467-fa2d029cfb61_fa216aee-1e43-4032-8c25-a863be919af5.html,,oral,LD50,"1,150 mg/kg bw",adverse effect observed, Bis(dodecylthio)dioctylstannane,22205-30-7," Read-across data: DOTI (CAS 26401 -97 -8) - Rat 13 week oral study (1970) Under the conditions of the study the 13 week oral no adverse effect level was found to be 150 ppm in male and female rats, the highest dose tested. - Dog 14 week oral study (1970) Under the conditions of the study the sub-chronic repeated dose oral no observed adverse effect level was 150 ppm in male and female beagle dogs, the highest dose level tested. - Oral 30 days rat and dog (1963) Under the conditions of the studies the NOAEL of the test material to male rats and dogs was 25 and 75 ppm, respectively. Read-across data - Rat 13 week oral study (mixture DOTE:MOTE:TOTE, 97: 0.3: 2.7) (CAS No 15571 -58 -1, CAS 27107-89-7, CAS 61912-55-8) The NOAEL was determined to be 10 ppm (equivalent to 0.5 mg/kg bw/day) and the LOAEL was determined to be 25 ppm (equivalent to 1.3 mg/kg bw/day) based on reduced thymus weight. Read-across data - Rat 13 week oral study (mixture DOTE: MOTE. 70:30) (CAS No 15571-58-1 and CAS 27107-89-7) The no effect level for the test material was determined to be 25 ppm (calculated as 1.25 mg/kg/day, based on a food factor of 0.05) based on reduced absolute and relative thymus gland weights. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/080bad3f-482c-4a7f-b9ab-a7930762b06b/documents/df6f8359-ed02-49ee-9081-f2a11f3ec87a_e70f0be4-3b81-4a27-9fd0-c39b9228d07b.html,,,,,, Bis(dodecylthio)dioctylstannane,22205-30-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/080bad3f-482c-4a7f-b9ab-a7930762b06b/documents/df6f8359-ed02-49ee-9081-f2a11f3ec87a_e70f0be4-3b81-4a27-9fd0-c39b9228d07b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.5 mg/kg bw/day,,rat Bis(dodecylthio)dioctylstannane,22205-30-7," ORAL TOXICITY Read-across to structurally similar substance (DOTI) (CAS No 26401 -97 -8) Auletta (1984) Under the conditions of this key study the acute oral LD50 of the read across substance was determined to be 1800 mg/kg with 95 % confidence interval of 1040 to 2560 mg/kg. INHALATION TOXICITY Read-across to structurally similar substance (DOTI) (CAS No 26401 -97 -8) Under the conditions of the study following a 7 hour treatment to a mixture of 80% read-across substance (DOTI) and 20% MOTI (CAS 26401-86-5), no mortality occurred. In some animals, a temporary conjunctivitis was observed during the post-treatment period. DERMAL TOXICITY Read-across to structurally similar substance (DOTE) (CAS No 15571 -58 -1) Following a single dermal application of a mixture of 90% read-across substance (DOTE) and 10% MOTE (CAS 27107 -89 -7) no mortality occured. The acute dermal toxicity LD50 (rat) of the test material was determined to be in excess of 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/080bad3f-482c-4a7f-b9ab-a7930762b06b/documents/9e173f5f-df87-4a97-ab69-3df4031e57c2_e70f0be4-3b81-4a27-9fd0-c39b9228d07b.html,,,,,, Bis(dodecylthio)dioctylstannane,22205-30-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/080bad3f-482c-4a7f-b9ab-a7930762b06b/documents/9e173f5f-df87-4a97-ab69-3df4031e57c2_e70f0be4-3b81-4a27-9fd0-c39b9228d07b.html,,oral,LD50,"1,800 mg/kg bw",adverse effect observed, Bis(dodecylthio)dioctylstannane,22205-30-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/080bad3f-482c-4a7f-b9ab-a7930762b06b/documents/9e173f5f-df87-4a97-ab69-3df4031e57c2_e70f0be4-3b81-4a27-9fd0-c39b9228d07b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Bis(ethyl acetoacetato-O1',O3)bis(2-methylpropan-1-olato)titanium",83877-91-2,"Repeated toxicity testing was considered unnecessary since this substance undergoes immediate disintegration and there are sufficient data on cleavage product. The intrinsic properties of this substance, after repeated administration, are related to the most hazardous degradation product Isobutanol. NOAEC was identified to be 1000 ppm (=3030 mg/m3). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdcdb69b-adba-4e4c-bd74-ec9d7262dc26/documents/dbf18586-4194-42ef-93bd-08c110b379b0_061cef93-9dcf-4923-ab3b-49ee62d90731.html,,,,,, "Bis(ethyl acetoacetato-O1',O3)bis(2-methylpropan-1-olato)titanium",83877-91-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdcdb69b-adba-4e4c-bd74-ec9d7262dc26/documents/dbf18586-4194-42ef-93bd-08c110b379b0_061cef93-9dcf-4923-ab3b-49ee62d90731.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"3,030 mg/m3",,rat "Bis(ethyl acetoacetato-O1',O3)bis(2-methylpropan-1-olato)titanium",83877-91-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdcdb69b-adba-4e4c-bd74-ec9d7262dc26/documents/dbf18586-4194-42ef-93bd-08c110b379b0_061cef93-9dcf-4923-ab3b-49ee62d90731.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"3,030 mg/m3",no adverse effect observed,rat "Bis(ethyl acetoacetato-O1',O3)bis(2-methylpropan-1-olato)titanium",83877-91-2,"Oral:The oral LD50 (rat; female) > 2000 mg/kg bw.Inhalation:There is no data available for acute inhalation toxicity for the target substance. The LC50 value for the most hazardous degradation product, 2-methylpropanol is > 18180 mg/m3.Dermal:There is no data available for acute dermal toxicity for the target substance. The LD50 value for the most hazardous degradation product, 2-methylpropanol is > 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdcdb69b-adba-4e4c-bd74-ec9d7262dc26/documents/89652863-0de4-4cf0-a643-0f5081d66f07_061cef93-9dcf-4923-ab3b-49ee62d90731.html,,,,,, "Bis(ethyl acetoacetato-O1',O3)bis(2-methylpropan-1-olato)titanium",83877-91-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdcdb69b-adba-4e4c-bd74-ec9d7262dc26/documents/89652863-0de4-4cf0-a643-0f5081d66f07_061cef93-9dcf-4923-ab3b-49ee62d90731.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Bis(ethyl acetoacetato-O1',O3)bis(2-methylpropan-1-olato)titanium",83877-91-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdcdb69b-adba-4e4c-bd74-ec9d7262dc26/documents/89652863-0de4-4cf0-a643-0f5081d66f07_061cef93-9dcf-4923-ab3b-49ee62d90731.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Bis(ethyl acetoacetato-O1',O3)bis(2-methylpropan-1-olato)titanium",83877-91-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdcdb69b-adba-4e4c-bd74-ec9d7262dc26/documents/89652863-0de4-4cf0-a643-0f5081d66f07_061cef93-9dcf-4923-ab3b-49ee62d90731.html,,inhalation,LC50,"18,180 mg/m3",no adverse effect observed, "Bis(ethyl acetoacetato-O1',O3)bis(propan-2-olato)titanium",27858-32-8,"Repeated toxicity testing was considered unnecessary since this substance undergoes immediate disintegration and there are sufficient data on cleavage product. The intrinsic properties of this substance, after repeated administration, are related to the most hazardous degradation product isopropyl alcohol (IPA). NOAEC was identified to be 5000 ppm (=12 300 mg/m3). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/713a9840-cb03-45da-9483-fb74f6d87039/documents/8d935e7d-7da7-421a-9ad3-877451d649ff_606e66a3-c71d-455a-9dfb-f059c691bf3c.html,,,,,, "Bis(ethyl acetoacetato-O1',O3)bis(propan-2-olato)titanium",27858-32-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/713a9840-cb03-45da-9483-fb74f6d87039/documents/8d935e7d-7da7-421a-9ad3-877451d649ff_606e66a3-c71d-455a-9dfb-f059c691bf3c.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"12,300 mg/m3",,rat "Bis(ethyl acetoacetato-O1',O3)bis(propan-2-olato)titanium",27858-32-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/713a9840-cb03-45da-9483-fb74f6d87039/documents/8d935e7d-7da7-421a-9ad3-877451d649ff_606e66a3-c71d-455a-9dfb-f059c691bf3c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"12,300 mg/m3",no adverse effect observed,rat "Bis(ethyl acetoacetato-O1',O3)bis(propan-2-olato)titanium",27858-32-8,Oral:The oral LD50 (rat; male) 23 020 mg/kg bwInhalation:There is no valid data available for acute inhalation toxicity for the substance. LC50 value is for the hazardous degradation product (IPA) 24 600 mg/m3.Dermal:Not relevant route of exposure. There is no valid data available for acute dermal toxicity for the substance. Information for IPA indicated the LD50 value of 12 870 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/713a9840-cb03-45da-9483-fb74f6d87039/documents/140c43cd-c5f5-4e41-b12c-505f10ba5e6e_606e66a3-c71d-455a-9dfb-f059c691bf3c.html,,,,,, "Bis(ethyl acetoacetato-O1',O3)bis(propan-2-olato)titanium",27858-32-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/713a9840-cb03-45da-9483-fb74f6d87039/documents/140c43cd-c5f5-4e41-b12c-505f10ba5e6e_606e66a3-c71d-455a-9dfb-f059c691bf3c.html,,oral,LD50,"23,020 mg/kg bw",no adverse effect observed, "Bis(ethyl acetoacetato-O1',O3)bis(propan-2-olato)titanium",27858-32-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/713a9840-cb03-45da-9483-fb74f6d87039/documents/140c43cd-c5f5-4e41-b12c-505f10ba5e6e_606e66a3-c71d-455a-9dfb-f059c691bf3c.html,,dermal,LD50,"12,870 mg/kg bw",no adverse effect observed, "Bis(ethyl acetoacetato-O1',O3)bis(propan-2-olato)titanium",27858-32-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/713a9840-cb03-45da-9483-fb74f6d87039/documents/140c43cd-c5f5-4e41-b12c-505f10ba5e6e_606e66a3-c71d-455a-9dfb-f059c691bf3c.html,,inhalation,LC50,"24,600 mg/m3",no adverse effect observed, Bis(glycinato)copper,13479-54-4,"In a study according to Guideline OECD 407, GLP, 2023, RL1, it was not possible to establish a NOAEL for the target substance. The LOAEL of the test item was 50 mg/kg/day in female and male Sprague Dawley rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac6e3b5e-e58d-417c-a7ee-382b3b711ad8/documents/7c0a7c79-aed1-4170-841d-19229a2763b2_f599ac3a-835f-4a92-8602-e06940f6a6b2.html,,,,,, Bis(glycinato)copper,13479-54-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac6e3b5e-e58d-417c-a7ee-382b3b711ad8/documents/7c0a7c79-aed1-4170-841d-19229a2763b2_f599ac3a-835f-4a92-8602-e06940f6a6b2.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,50 mg/kg bw/day,,rat Bis(glycinato)copper,13479-54-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac6e3b5e-e58d-417c-a7ee-382b3b711ad8/documents/7c0a7c79-aed1-4170-841d-19229a2763b2_f599ac3a-835f-4a92-8602-e06940f6a6b2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,27.1 mg/kg bw/day,,rat Bis(glycinato)copper,13479-54-4,"The study was conducted according to OECD guideline 425 under GLP conditions, thus, there are no limitations to the quality of the database. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac6e3b5e-e58d-417c-a7ee-382b3b711ad8/documents/d6efc9ab-7e77-479b-9285-f9a1a2eb0150_f599ac3a-835f-4a92-8602-e06940f6a6b2.html,,,,,, Bis(glycinato)copper,13479-54-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac6e3b5e-e58d-417c-a7ee-382b3b711ad8/documents/d6efc9ab-7e77-479b-9285-f9a1a2eb0150_f599ac3a-835f-4a92-8602-e06940f6a6b2.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, CGA 042,143925-92-2, The test item did not induce acute toxicity after oral and dermal application at 2000 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2dfdddf-18c6-45eb-b28e-7170a27417b8/documents/IUC5-0051111c-d689-4abd-a545-43d865d0bc9a_e4b1779e-6c68-46b8-aeb8-69c9c23d7d04.html,,,,,, CGA 042,143925-92-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2dfdddf-18c6-45eb-b28e-7170a27417b8/documents/IUC5-0051111c-d689-4abd-a545-43d865d0bc9a_e4b1779e-6c68-46b8-aeb8-69c9c23d7d04.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, CGA 042,143925-92-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2dfdddf-18c6-45eb-b28e-7170a27417b8/documents/IUC5-0051111c-d689-4abd-a545-43d865d0bc9a_e4b1779e-6c68-46b8-aeb8-69c9c23d7d04.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Bis(isopropyl) thioperoxydicarbonate,105-65-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39a4fa96-1d54-4475-a49a-d06065c3d1bc/documents/d79b99f9-852b-4d39-90d5-98f5edf105f1_ea17db15-a747-4ce6-87e1-4eab9138aa2a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Bis(isopropyl)naphthalene,38640-62-9,"One key study concerning repeated dose toxicity was identified (Kawai, 1973; rat, oral, 6 months). In this study a NOAEL of 170 mg/kg/day was determined. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eba71513-f4b2-42a2-aa01-9896bfbf90ce/documents/c4c0ee7d-5ff3-4169-8eee-2f3da720e9db_57e64408-f454-4770-bd93-0d6240fbd763.html,,,,,, Bis(isopropyl)naphthalene,38640-62-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eba71513-f4b2-42a2-aa01-9896bfbf90ce/documents/c4c0ee7d-5ff3-4169-8eee-2f3da720e9db_57e64408-f454-4770-bd93-0d6240fbd763.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,170 mg/kg bw/day,,rat Bis(isopropyl)naphthalene,38640-62-9,"The oral LD50 of bis(isopropyl)naphthalene (DIPN) was determined to be 4130 mg/kg bw in male rats and 4320 mg/kg bw in female rats (MITES, 1982).In a limit test, no mortality was observed for rats exposed to an analytically verified DIPN aerosol concentration of 5.64 mg/L for 4 hours (RCC, 1988).In a limit test, no mortality was observed for rats following dermal administration of 9250 mg/kg (IBR, 1986). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eba71513-f4b2-42a2-aa01-9896bfbf90ce/documents/a314b810-eb1d-4bfa-abcf-a87d6a12c854_57e64408-f454-4770-bd93-0d6240fbd763.html,,,,,, Bis(isopropyl)naphthalene,38640-62-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eba71513-f4b2-42a2-aa01-9896bfbf90ce/documents/a314b810-eb1d-4bfa-abcf-a87d6a12c854_57e64408-f454-4770-bd93-0d6240fbd763.html,,oral,LD50,"4,130 mg/kg bw",, Bis(isopropyl)naphthalene,38640-62-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eba71513-f4b2-42a2-aa01-9896bfbf90ce/documents/a314b810-eb1d-4bfa-abcf-a87d6a12c854_57e64408-f454-4770-bd93-0d6240fbd763.html,,dermal,LD50,"4,500 mg/kg bw",, Bis(isopropyl)naphthalene,38640-62-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eba71513-f4b2-42a2-aa01-9896bfbf90ce/documents/a314b810-eb1d-4bfa-abcf-a87d6a12c854_57e64408-f454-4770-bd93-0d6240fbd763.html,,inhalation,LC50,"5,640 mg/m3",, Bis(methylcyclohexyl) phthalate,27987-25-3," 2_Gen (RA 84 -61 -7): NOAEL = 1200 ppm (Tox. Science, 2005) ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d7621ac-a004-4570-96e1-d95cfa7e634b/documents/ad355176-20ed-436b-9aa5-5ab3939b57d2_680d62a2-5846-4317-bd35-25d2de542932.html,,,,,, Bis(methylcyclohexyl) phthalate,27987-25-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d7621ac-a004-4570-96e1-d95cfa7e634b/documents/ad355176-20ed-436b-9aa5-5ab3939b57d2_680d62a2-5846-4317-bd35-25d2de542932.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat Bis(methylcyclohexyl) phthalate,27987-25-3, LD50 (oral): >2000 mg/kg bw ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d7621ac-a004-4570-96e1-d95cfa7e634b/documents/30a5c3ae-0ef3-401a-83fd-53cdb19512f3_680d62a2-5846-4317-bd35-25d2de542932.html,,,,,, Bis(methylcyclohexyl) phthalate,27987-25-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d7621ac-a004-4570-96e1-d95cfa7e634b/documents/30a5c3ae-0ef3-401a-83fd-53cdb19512f3_680d62a2-5846-4317-bd35-25d2de542932.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bis(N-(7-hydroxy-8-methyl-5-phenylphenazin-3-ylidene)dimethylammonium) sulfate,149057-64-7,"During 28-day oral administration study of the test substance in the dosages of 0, 8, 40 or 200 mg/kg bw./ day the following results were obtained. The 28-day oral administration of the test substance in the dosage of 200 mg/kg bw. per day resulted in an influence on the general state of health. The death of two animals is also related to the administration of the test substance. Striking is the fact that neither haematological and clinical-chemical parameters nor histopathological examinations provided evidence of a toxic effect of the test substance. The 28-day administration of the test substance at doses of 40 or 8 mg/kg bw. per day did not result in any noticeable toxic damage to the test animals. Based on the present study, the NOAEL is therefore 40 mg/kg bw./day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 2 Reliable with restrictions due to age of study and reporting. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2da6081-64db-4dad-8ea1-50848a3941db/documents/dcb03251-c2f8-4d37-b3b4-db311fb31951_90363dea-10e6-44f8-a321-00599d36855d.html,,,,,, Bis(N-(7-hydroxy-8-methyl-5-phenylphenazin-3-ylidene)dimethylammonium) sulfate,149057-64-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2da6081-64db-4dad-8ea1-50848a3941db/documents/dcb03251-c2f8-4d37-b3b4-db311fb31951_90363dea-10e6-44f8-a321-00599d36855d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat Bis(N-(7-hydroxy-8-methyl-5-phenylphenazin-3-ylidene)dimethylammonium) sulfate,149057-64-7,"The test substance was found to be non-toxic upon acute oral toxicity testing in rat with doses up to 2000 mg/kg bw. In addition, it is non-toxic upon acute skin contact based on experimental data obtained with rabbits treated with 2000 mg/kg bw. test substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable and valid. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Reliable and valid. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2da6081-64db-4dad-8ea1-50848a3941db/documents/be7a1dfc-95ae-441c-ab8a-0ac7e066ce39_90363dea-10e6-44f8-a321-00599d36855d.html,,,,,, Bis(N-(7-hydroxy-8-methyl-5-phenylphenazin-3-ylidene)dimethylammonium) sulfate,149057-64-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2da6081-64db-4dad-8ea1-50848a3941db/documents/be7a1dfc-95ae-441c-ab8a-0ac7e066ce39_90363dea-10e6-44f8-a321-00599d36855d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bis(N-(7-hydroxy-8-methyl-5-phenylphenazin-3-ylidene)dimethylammonium) sulfate,149057-64-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2da6081-64db-4dad-8ea1-50848a3941db/documents/be7a1dfc-95ae-441c-ab8a-0ac7e066ce39_90363dea-10e6-44f8-a321-00599d36855d.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Bis(N,N',N''-trimethyl-1,4,7-triazacyclononane)-trioxo-dimanganese (IV) di(hexafluorophosphate)monohydrate",116633-53-5,"OECD 407_supporting study: Rats, (10/sex/group) were dosed by oral gavage seven days/week for four weeks with Commercial Dragon II (0, 1, 15, 40, 200 or 1000 mg/kg). In addition, 10 males and 10 females in both the control and high-dose groups were continued for two weeks after treatment as recovery groups. Clinical signs, changes in haematology and clinical chemistry parameters and histological changes in the liver and pituitary were observed in rats in the higher dose groups. Histological changes were observed in the thyroid of rats in the 40, 200 and 1000 mg/kg/day dose groups. Following a two-week recovery period, many of these observed changes regressed, and some reverted to control levels. Based on the observed histopathological changes in the thyroid gland, the NOAEL was established at 15 mg/kg/day. OECD 408_key study: Five groups of 20 male and 20 female rats were dosed by oral gavage with Commercial Dragon II (0.01, 0.1, 1, 5 and 500 mg/kg/d) for 13 weeks. A control group of 20 male and 20 female rats were dosed with the vehicle (water). In addition two further groups of 10 male and 10 female rats from both the control and the high dose groups were continued for a recovery period of 8 weeks after the 13 weeks treatment period. Also satellite groups of 10 male and 10 female rats from the control and high dose groups were killed at the end of the 13 weeks treatment period and a range of tissues was taken for analysis of manganese. Faecal analysis, urinalysis, haematology and clinical chemistry examination revealed changes in rats from the top dose group. In addition, histological changes were identified in the pituitary of male rats and in the thyroid of male and female rats of the top dose group. Following an eight-week recovery period, most of these changes regressed or reverted to normal levels. All the males and five out of 10 of the females treated with 500 mg/kg/day showed an increase in the number of thyroid follicles. The no observed adversed effect level (NOAEL) was concluded >5 mg/kg/d of Commercial Dragon II.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96deea9d-9be1-4c77-af2d-0d820ddfe206/documents/1539b42b-9d0b-4a03-9b46-52afe6593c77_bc4002fd-ac42-4e18-a5be-bc0dc89f1353.html,,,,,, "Bis(N,N',N''-trimethyl-1,4,7-triazacyclononane)-trioxo-dimanganese (IV) di(hexafluorophosphate)monohydrate",116633-53-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96deea9d-9be1-4c77-af2d-0d820ddfe206/documents/1539b42b-9d0b-4a03-9b46-52afe6593c77_bc4002fd-ac42-4e18-a5be-bc0dc89f1353.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "Bis(N,N',N''-trimethyl-1,4,7-triazacyclononane)-trioxo-dimanganese (IV) di(hexafluorophosphate)monohydrate",116633-53-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96deea9d-9be1-4c77-af2d-0d820ddfe206/documents/1539b42b-9d0b-4a03-9b46-52afe6593c77_bc4002fd-ac42-4e18-a5be-bc0dc89f1353.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,> 5 mg/kg bw/day,,rat "Bis(N,N',N''-trimethyl-1,4,7-triazacyclononane)-trioxo-dimanganese (IV) di(hexafluorophosphate)monohydrate",116633-53-5,"Acute toxicity: via oral route Results of the two conducted studies showed acute oral toxicity (LD50, rat) values of >5000 mg/kg and >2000 mg/kg. Taking the precautionary principle into account, the lowest of these equally reliable values (>2000 mg/kg) was considered to be the acute oral toxicity level. Acute toxicity: via dermal route: LD50 >2000 mg/kg bw Acute toxicity: via inhalation route: no study available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96deea9d-9be1-4c77-af2d-0d820ddfe206/documents/565bf8fd-bad9-4897-b2c2-6c358323b6cf_bc4002fd-ac42-4e18-a5be-bc0dc89f1353.html,,,,,, "Bis(N,N',N''-trimethyl-1,4,7-triazacyclononane)-trioxo-dimanganese (IV) di(hexafluorophosphate)monohydrate",116633-53-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96deea9d-9be1-4c77-af2d-0d820ddfe206/documents/565bf8fd-bad9-4897-b2c2-6c358323b6cf_bc4002fd-ac42-4e18-a5be-bc0dc89f1353.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Bis(N,N',N''-trimethyl-1,4,7-triazacyclononane)-trioxo-dimanganese (IV) di(hexafluorophosphate)monohydrate",116633-53-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96deea9d-9be1-4c77-af2d-0d820ddfe206/documents/565bf8fd-bad9-4897-b2c2-6c358323b6cf_bc4002fd-ac42-4e18-a5be-bc0dc89f1353.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Bis(neodecanoyloxy)dioctylstannane,68299-15-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba35deeb-bb9f-4959-ad58-b2402b41c7a2/documents/4c72b5db-ad0b-42f3-8c9a-82076789f2ae_57a5c1f0-71a3-4418-81b2-2838589f72e1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,1.25 mg/kg bw/day,,rat Bis(neodecanoyloxy)dioctylstannane,68299-15-0, one Guideline study on acute toxicity by the oral route available ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba35deeb-bb9f-4959-ad58-b2402b41c7a2/documents/706138de-426c-450b-8b7d-356604a1d93c_57a5c1f0-71a3-4418-81b2-2838589f72e1.html,,,,,, Bis(neodecanoyloxy)dioctylstannane,68299-15-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba35deeb-bb9f-4959-ad58-b2402b41c7a2/documents/706138de-426c-450b-8b7d-356604a1d93c_57a5c1f0-71a3-4418-81b2-2838589f72e1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Bis(neodecanoyloxy)dioctylstannane,68299-15-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba35deeb-bb9f-4959-ad58-b2402b41c7a2/documents/706138de-426c-450b-8b7d-356604a1d93c_57a5c1f0-71a3-4418-81b2-2838589f72e1.html,,dermal,LD50,"2,001 ",no adverse effect observed, "bis(O,O-2-ethylhexyl-thiophosphoryl)polysulfide",174125-93-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Study was conducted on the registered substance itself acc. OECD TG 422 under GLP. Hence, the tonnage-driven data requirements under REACH are fully met, and the database is of high quality. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a5a80d1-60cf-4aa5-b5e0-6ecd8abff99d/documents/7fc993ad-2b7d-4395-a90a-9fa3ec40b69f_f2817346-14f5-4560-b635-79abf4c5e92d.html,,,,,, "bis(O,O-2-ethylhexyl-thiophosphoryl)polysulfide",174125-93-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a5a80d1-60cf-4aa5-b5e0-6ecd8abff99d/documents/7fc993ad-2b7d-4395-a90a-9fa3ec40b69f_f2817346-14f5-4560-b635-79abf4c5e92d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "bis(O,O-2-ethylhexyl-thiophosphoryl)polysulfide",174125-93-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available study was performed according to OECD 401 under GLP. The method is to be considered scientifically reasonable with negligible deficiencies and methodological variations due to the intrinsic properties of the test item, which are foreseen in the guideline. Hence, the results can be considered as sufficiently reliable to assess the acute oral toxicity in rats. The determined LD50 value is >2000 mg/kg bw, the LD0 ≥ 2000 mg/kg in rats, so an underestimation of the actual hazard is highly unlikely. Hence, the database is of high quality. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a5a80d1-60cf-4aa5-b5e0-6ecd8abff99d/documents/bf8a966d-8053-43c5-b844-b35d7533d161_f2817346-14f5-4560-b635-79abf4c5e92d.html,,,,,, "bis(O,O-2-ethylhexyl-thiophosphoryl)polysulfide",174125-93-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a5a80d1-60cf-4aa5-b5e0-6ecd8abff99d/documents/bf8a966d-8053-43c5-b844-b35d7533d161_f2817346-14f5-4560-b635-79abf4c5e92d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Bis(O,O-diisopropyl dithiophosphate)bis(cyclohexylamine) zinc",52585-16-7," OECD 422 (oral, rat): NOAEL = 50 mg/kg bw/day for systemic toxicity and local effects in stomach ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78102be4-e7e7-4a3c-86a2-63e662b4d56e/documents/4c93dcad-2ac7-45ac-b319-698a2b053c5a_329f55ef-5bc1-44db-8897-1c0c493e6d0f.html,,,,,, "Bis(O,O-diisopropyl dithiophosphate)bis(cyclohexylamine) zinc",52585-16-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78102be4-e7e7-4a3c-86a2-63e662b4d56e/documents/4c93dcad-2ac7-45ac-b319-698a2b053c5a_329f55ef-5bc1-44db-8897-1c0c493e6d0f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Bis(O,O-diisopropyl dithiophosphate)bis(cyclohexylamine) zinc",52585-16-7, Oral LD50 > 300 - 2000 mg/kg bw Dermal LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78102be4-e7e7-4a3c-86a2-63e662b4d56e/documents/0db10c86-73f2-46c2-9817-eeae2d641630_329f55ef-5bc1-44db-8897-1c0c493e6d0f.html,,,,,, "Bis(O,O-diisopropyl dithiophosphate)bis(cyclohexylamine) zinc",52585-16-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78102be4-e7e7-4a3c-86a2-63e662b4d56e/documents/0db10c86-73f2-46c2-9817-eeae2d641630_329f55ef-5bc1-44db-8897-1c0c493e6d0f.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "Bis(p-aminophenyl)-4-methylenecyclohexa-2,5-dienylideneammonium acetate",6035-94-5," Acute oral toxicity: The LD50 was estimated to be 3040 mg/kg bw, when Wistar male and female rats were orally exposed with Bis(p-aminophenyl)-4-methylenecyclohexa-2,5-dienylideneammonium acetate (6035-94-5). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69000b47-d4dc-457b-b361-287a2f1e310c/documents/e805247b-41ff-433b-b857-4d8e9bc79e43_eadf9ad7-98ae-469a-b767-8bbe0f1f45f3.html,,,,,, "Bis(p-aminophenyl)-4-methylenecyclohexa-2,5-dienylideneammonium acetate",6035-94-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69000b47-d4dc-457b-b361-287a2f1e310c/documents/e805247b-41ff-433b-b857-4d8e9bc79e43_eadf9ad7-98ae-469a-b767-8bbe0f1f45f3.html,,oral,LD50,"3,040 mg/kg bw",no adverse effect observed, "Bis(pentane-2,4-dionato)calcium",19372-44-2,"A 14-week inhalation study in rats is available for the read-across substance, 2,4-pentanedione. The most noteworthy systemics observations in the 14-week inhalation study were the brain and thymus lesions in animals that died due to inhalation of 650 ppm of 2,4-pentanedione. Mild squamous metaplasia in the nasal mucosa was observed in the 650 ppm rats. Perhaps inflammation in the nasal mucosa is a transient response at 2,4-pentanedione concentrations of 200 ppm and higher. Rats exposed to 100 ppm of 2,4-pentanedione for 14 weeks showed no signs of irritancy or toxicity (nominal concentrations, corresponding to 417; 1,217 and 2,711 mg/m3) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f1d99f1-84a7-4189-9536-880aad69b2df/documents/IUC5-98249ddf-73d6-4db7-b386-542dd4a67204_3dfdf997-deec-482b-8c82-c2849fd82d54.html,,,,,, "Bis(pentane-2,4-dionato)calcium",19372-44-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f1d99f1-84a7-4189-9536-880aad69b2df/documents/IUC5-98249ddf-73d6-4db7-b386-542dd4a67204_3dfdf997-deec-482b-8c82-c2849fd82d54.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,217 mg/m3",,rat "Bis(pentane-2,4-dionato)calcium",19372-44-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f1d99f1-84a7-4189-9536-880aad69b2df/documents/IUC5-98249ddf-73d6-4db7-b386-542dd4a67204_3dfdf997-deec-482b-8c82-c2849fd82d54.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,217 mg/m3",adverse effect observed,rat "Bis(pentane-2,4-dionato)calcium",19372-44-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f1d99f1-84a7-4189-9536-880aad69b2df/documents/IUC5-5b5bb8d1-2924-4f76-ab18-0c80c1e7701b_3dfdf997-deec-482b-8c82-c2849fd82d54.html,,oral,LD50,"1,250 mg/kg bw",adverse effect observed, "Bis(pentane-2,4-dionato-O,O')bis(propan-2-olato)titanium",17927-72-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): K2 level data obtained by QSAR estimation study ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcb9c916-fd33-46b5-82c4-d2f282aded8d/documents/IUC5-ae123995-62a3-4f48-a530-2e6cc2278088_330f0385-bef2-4393-997d-a73472327d6a.html,,,,,, "Bis(pentane-2,4-dionato-O,O')bis(propan-2-olato)titanium",17927-72-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcb9c916-fd33-46b5-82c4-d2f282aded8d/documents/IUC5-ae123995-62a3-4f48-a530-2e6cc2278088_330f0385-bef2-4393-997d-a73472327d6a.html,Short-term repeated dose toxicity – systemic effects,oral,,"1,208.092 mg/kg bw/day",,rat "Bis(pentane-2,4-dionato-O,O')bis(propan-2-olato)titanium",17927-72-9,"The substance, bis(pentane-2,4-dionato-O,O')bis(propan-2-olato)titanium, is non toxic to oral and dermal route. in case of inhalation,  this end point was considered for waiver since given the very low vapour pressure the exposure of humans via inhalation is highly unlikely and their is negligible possibility of exposure to aerosols, particles or droplets of an inhalable size.. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcb9c916-fd33-46b5-82c4-d2f282aded8d/documents/IUC5-28a0b97a-5b3d-4b10-b877-fb774559090c_330f0385-bef2-4393-997d-a73472327d6a.html,,,,,, "Bis(pentane-2,4-dionato-O,O')bis(propan-2-olato)titanium",17927-72-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcb9c916-fd33-46b5-82c4-d2f282aded8d/documents/IUC5-28a0b97a-5b3d-4b10-b877-fb774559090c_330f0385-bef2-4393-997d-a73472327d6a.html,,oral,LD50,"2,038 mg/kg bw",no adverse effect observed, "Bis(pentane-2,4-dionato-O,O')bis(propan-2-olato)titanium",17927-72-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcb9c916-fd33-46b5-82c4-d2f282aded8d/documents/IUC5-28a0b97a-5b3d-4b10-b877-fb774559090c_330f0385-bef2-4393-997d-a73472327d6a.html,,dermal,LD50,"6,350 mg/kg bw",no adverse effect observed, "Bis(pentane-2,4-dionato-O,O')nickel",3264-82-2," L’évaluation dela toxicité aiguë de la substance à enregistrer après administration par voie orale, cutanée et par inhalation montre que l’acétylacétonate de Nickel doit être considéré comme nocif en cas d'ingestion et d'inhalation mais pas en cas de contact cutané. Conformément au règlement (CE) n° 1272/2008 et ses adaptations, la classification de l’acétylacétonate de Cobalt est la suivante : Toxicité aigüe par voie orale : Catégorie 4 (Acute Tox. 4, H302 Toxicité aigüe par inhalation : Catégorie 4 (Acute Tox. 4, H332) Toxicité aigüe par voie cutanée: Catégorie 4 (Acute Tox. 4, H312) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8dd2da8-ffef-4ab7-8d5f-b5e2d36fdce7/documents/fb76108d-078f-4e8f-9ecc-70eafe22d5b7_9d3a730d-d95a-48bd-9fd3-7e8f73417ba9.html,,,,,, "Bis(pentane-2,4-dionato-O,O')nickel",3264-82-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8dd2da8-ffef-4ab7-8d5f-b5e2d36fdce7/documents/fb76108d-078f-4e8f-9ecc-70eafe22d5b7_9d3a730d-d95a-48bd-9fd3-7e8f73417ba9.html,,oral,LD50,426 mg/kg bw,adverse effect observed, "Bis(pentane-2,4-dionato-O,O')nickel",3264-82-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8dd2da8-ffef-4ab7-8d5f-b5e2d36fdce7/documents/fb76108d-078f-4e8f-9ecc-70eafe22d5b7_9d3a730d-d95a-48bd-9fd3-7e8f73417ba9.html,,dermal,LD50,"1,334 mg/kg bw",adverse effect observed, "Bis(pentane-2,4-dionato-O,O')zinc",14024-63-6," A 14-week inhalation study in rats is available for the read-across substance, 2,4-pentanedione.  The most noteworthy systemics observations in the 14-week inhalation study were the brain and thymus lesions in animals that died due to inhalation of 650 ppm of 2,4-pentanedione. Mild squamous metaplasia in the nasal mucosa was observed in the 650 ppm rats. Perhaps inflammation in the nasal mucosa is a transient response at 2,4-pentanedione concentrations of 307 ppm and higher. Rats exposed to 100 ppm of 2,4-pentanedione for 14 weeks showed no signs of irritancy or toxicity (nominal concentrations, corresponding to 413; 1,255 and 2,657 mg/m3). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/68121d20-5555-487e-ad5a-e0a74110f091/documents/34af692d-5ac6-482a-bb08-9a8a5eeb9d73_b06c29d6-3e5a-4535-a544-83f8a94c6384.html,,,,,, "Bis(pentane-2,4-dionato-O,O')zinc",14024-63-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/68121d20-5555-487e-ad5a-e0a74110f091/documents/34af692d-5ac6-482a-bb08-9a8a5eeb9d73_b06c29d6-3e5a-4535-a544-83f8a94c6384.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,545 mg/m3,,rat "Bis(pentane-2,4-dionato-O,O')zinc",14024-63-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/68121d20-5555-487e-ad5a-e0a74110f091/documents/34af692d-5ac6-482a-bb08-9a8a5eeb9d73_b06c29d6-3e5a-4535-a544-83f8a94c6384.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"1,255 mg/m3",adverse effect observed,rat "Bis(pentane-2,4-dionato-O,O')zinc",14024-63-6," After oral application of 2000 mg/kg bw of the test substance 1 of 3 animals died. Thus the LD50 oral can be determined as > 2000 mg/kg bw. In a read-across approach an inhalative toxicity study with bis(pentane-2,4 -dionate)calcium is used for classification. It can be stated that the LC50 inhalative is higher than 5.47 mg/L. In a read-across approach an dermal toxicity study with bis(pentane-2,4 -dionate)calcium is used for classification. It can be stated that the LD50 dermal is higher than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68121d20-5555-487e-ad5a-e0a74110f091/documents/31ad0af3-d33e-45ea-82fd-2c0fadb88b49_b06c29d6-3e5a-4535-a544-83f8a94c6384.html,,,,,, Bis(piperidinothiocarbonyl) hexasulphide,971-15-3,"At 1000 mg/kg/day, the test item was clinically well-tolerated and no relevant findings were noted at clinical pathology after 28 -day and 90 -day of exposure. the No Observed Adverse Effect Level (NOAEL) was established at 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d470e74f-9383-4497-878a-5ff890ff9192/documents/IUC5-17b80efe-1e25-4c57-9e59-b36302c016a1_ab1aa227-cbd1-4504-b5eb-cb9ffa3a1ff3.html,,,,,, Bis(piperidinothiocarbonyl) hexasulphide,971-15-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d470e74f-9383-4497-878a-5ff890ff9192/documents/IUC5-17b80efe-1e25-4c57-9e59-b36302c016a1_ab1aa227-cbd1-4504-b5eb-cb9ffa3a1ff3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Bis(piperidinothiocarbonyl) hexasulphide,971-15-3,"Three acute studies are available on DPTH : one by oral route (LD0> 2000 mg/kg in rats), one by dermal route (LD0> 2000 mg/kg in rats) and one by inhalation (LC0> 2.83 mg/L). No mortality was observed in these acute studies, DPTH is not to be considered as harmful by these all three routes of exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d470e74f-9383-4497-878a-5ff890ff9192/documents/IUC5-c45b8ff1-80fa-4257-870c-df7acc6371cf_ab1aa227-cbd1-4504-b5eb-cb9ffa3a1ff3.html,,,,,, Bis(piperidinothiocarbonyl) hexasulphide,971-15-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d470e74f-9383-4497-878a-5ff890ff9192/documents/IUC5-c45b8ff1-80fa-4257-870c-df7acc6371cf_ab1aa227-cbd1-4504-b5eb-cb9ffa3a1ff3.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bis(piperidinothiocarbonyl) hexasulphide,971-15-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d470e74f-9383-4497-878a-5ff890ff9192/documents/IUC5-c45b8ff1-80fa-4257-870c-df7acc6371cf_ab1aa227-cbd1-4504-b5eb-cb9ffa3a1ff3.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bis(piperidinothiocarbonyl) hexasulphide,971-15-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d470e74f-9383-4497-878a-5ff890ff9192/documents/IUC5-c45b8ff1-80fa-4257-870c-df7acc6371cf_ab1aa227-cbd1-4504-b5eb-cb9ffa3a1ff3.html,,inhalation,discriminating conc.,"2,830 mg/m3",no adverse effect observed, Bis(p-methoxyphenyl)iodonium bromide,19231-06-2," The acute toxic class method was carried out involving a stepwise procedure with the use of 2000 mg/kg bw as the starting dose in three female rats. Since three female animals died the test was continued at 300 mg/kg bw dose level on further three female rats. No animal died in the second step at 300 mg/kg bw dose level, further three female rats were treated with the same (300 mg/kg bw) dose. No animal died in the third step, too, so the test was finished, the stopping criteria of Annex 2d of OECD Guideline No. 423. was met. The test item was ranked into the Acute Toxicity, via oral route category 4 according the classes of Globally Harmonized Classification System (GHS). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad8fed36-e3e4-4d01-92e5-6dc5effc6c1e/documents/9b50043d-c190-4b66-b718-a5b3319060a3_817da13d-d55d-4d13-99ba-d66feba3a52e.html,,,,,, Bis(p-methoxyphenyl)iodonium bromide,19231-06-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad8fed36-e3e4-4d01-92e5-6dc5effc6c1e/documents/9b50043d-c190-4b66-b718-a5b3319060a3_817da13d-d55d-4d13-99ba-d66feba3a52e.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, Bis(triethoxysilylpropyl)amine,13497-18-2,"Oral: Combined-Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422), rat: NOAEL (systemic) = 150 mg/kg bw/day   In order to fulfil the standard information requirements, a GLP-compliant 90-day repeated dose toxicity study in rats via the oral route following OECD TG 408 will be conducted as per ECHA decision number TPE-D-2114636436-46-01/F. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21625cc1-28e9-4d5c-8f0f-3561644f6343/documents/e0bae3d1-0623-4a66-9cdd-10196ac75966_8e59d3da-0d23-4808-a097-6d2cd9399daf.html,,,,,, Bis(triethoxysilylpropyl)amine,13497-18-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21625cc1-28e9-4d5c-8f0f-3561644f6343/documents/e0bae3d1-0623-4a66-9cdd-10196ac75966_8e59d3da-0d23-4808-a097-6d2cd9399daf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Bis(triethoxysilylpropyl)amine,13497-18-2,"Oral (OECD 401), rat: LD50 = 3657 mg/kg bwDermal (OECD 402), rat: LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21625cc1-28e9-4d5c-8f0f-3561644f6343/documents/ef469408-0d0c-412f-98ac-ed905e17573d_8e59d3da-0d23-4808-a097-6d2cd9399daf.html,,,,,, Bis(triethoxysilylpropyl)amine,13497-18-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21625cc1-28e9-4d5c-8f0f-3561644f6343/documents/ef469408-0d0c-412f-98ac-ed905e17573d_8e59d3da-0d23-4808-a097-6d2cd9399daf.html,,oral,LD50,"3,657 mg/kg bw",adverse effect observed, Bis(triethoxysilylpropyl)amine,13497-18-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21625cc1-28e9-4d5c-8f0f-3561644f6343/documents/ef469408-0d0c-412f-98ac-ed905e17573d_8e59d3da-0d23-4808-a097-6d2cd9399daf.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Bis(trimethoxysilylpropyl)amine,82985-35-1,"Oral (OECD 407), rat: NOAEL (systemic) = 1000 mg/kg bw/day; NOAEL (local) = 300 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd50df20-c4b1-47e5-9632-e6b76d2c00d3/documents/b62d58c9-5e59-4d8a-b0e0-fd1a716ed029_b0a818be-dc2e-4d0d-b530-4d63b5c49065.html,,,,,, Bis(trimethoxysilylpropyl)amine,82985-35-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd50df20-c4b1-47e5-9632-e6b76d2c00d3/documents/b62d58c9-5e59-4d8a-b0e0-fd1a716ed029_b0a818be-dc2e-4d0d-b530-4d63b5c49065.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Bis(trimethoxysilylpropyl)amine,82985-35-1,"Oral (similar to OECD TG 401), rat: LD50 > 4200 mg/kg bw (male) and 3780 mg/kg bw (female)Dermal (similar to OECD TG 402), rabbit: LD50 = 16800 mg/kg bw (male) and 11865 mg/kg bw (female) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd50df20-c4b1-47e5-9632-e6b76d2c00d3/documents/f2a3649b-ca5c-4042-8716-3654a2fc5064_b0a818be-dc2e-4d0d-b530-4d63b5c49065.html,,,,,, Bis(trimethoxysilylpropyl)amine,82985-35-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd50df20-c4b1-47e5-9632-e6b76d2c00d3/documents/f2a3649b-ca5c-4042-8716-3654a2fc5064_b0a818be-dc2e-4d0d-b530-4d63b5c49065.html,,oral,LD50,"3,780 mg/kg bw",adverse effect observed, Bis(trimethoxysilylpropyl)amine,82985-35-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd50df20-c4b1-47e5-9632-e6b76d2c00d3/documents/f2a3649b-ca5c-4042-8716-3654a2fc5064_b0a818be-dc2e-4d0d-b530-4d63b5c49065.html,,dermal,LD50,"11,865 mg/kg bw",adverse effect observed, "Bis(α,α-dimethylbenzyl) peroxide",80-43-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3dd53a20-928d-4805-a6f4-5fa9544da183/documents/IUC5-1ad59ba8-df84-4b05-887a-2129b011da93_d87094b2-fdd8-4545-b5ed-c31d2d2126d9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat "Bis(α,α-dimethylbenzyl) peroxide",80-43-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3dd53a20-928d-4805-a6f4-5fa9544da183/documents/IUC5-a07586e2-1417-4903-b626-888a09aba6f4_d87094b2-fdd8-4545-b5ed-c31d2d2126d9.html,,oral,discriminating dose,"2,000 mg/kg bw",, "Bis(α,α-dimethylbenzyl) peroxide",80-43-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3dd53a20-928d-4805-a6f4-5fa9544da183/documents/IUC5-a07586e2-1417-4903-b626-888a09aba6f4_d87094b2-fdd8-4545-b5ed-c31d2d2126d9.html,,dermal,discriminating dose,"2,000 mg/kg bw",, Bis[(2-ethyl-1-oxohexyl)oxy]dioctylstannane,24577-34-2," Read-across to structurally similar substance DOTO (Dioctyltin oxide), CAS 870-08-6 Based on the effects noted in the thymus in both male and female rats in the 25 mg/kg diet groups, the NOAEL was concluded to be the lowest group tested, 5 mg/kg diet which was equivalent to 0.3-0.4 mg/kg bw/day for male animals and 0.3-0.5 mg/kg bw/day for female animals. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/957f6d37-1947-4cb2-867e-49f31447b712/documents/ee127f0e-6edd-48f2-9da9-681fa6ba21a6_33250ca1-d0b0-405a-b9a8-9df3134635f0.html,,,,,, Bis[(2-ethyl-1-oxohexyl)oxy]dioctylstannane,24577-34-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/957f6d37-1947-4cb2-867e-49f31447b712/documents/ee127f0e-6edd-48f2-9da9-681fa6ba21a6_33250ca1-d0b0-405a-b9a8-9df3134635f0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,0.3 mg/kg bw/day,,rat Bis[(2-ethyl-1-oxohexyl)oxy]dioctylstannane,24577-34-2," Oral Under the conditions of the study, the acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. Dermal - Read-across to structurally similar substance DOTO (Dioctyltin oxide), CAS 870-08-6 Under the conditions of the study, the acute dermal median lethal dose (LD50) of the test material in the Wistar strain of rat was determined to be greater than 2000 mg/kg bw. - Read-across to structurally similar substance DOT bis-(ethylmaleate), CAS 68109-88-6 Under the conditions of the study, the LD50 of the test material in the Wistar strain rat was determined to be greater than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/957f6d37-1947-4cb2-867e-49f31447b712/documents/d39cbd1e-09fd-4be7-a844-73d2606315c5_33250ca1-d0b0-405a-b9a8-9df3134635f0.html,,,,,, Bis[(2-ethyl-1-oxohexyl)oxy]dioctylstannane,24577-34-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/957f6d37-1947-4cb2-867e-49f31447b712/documents/d39cbd1e-09fd-4be7-a844-73d2606315c5_33250ca1-d0b0-405a-b9a8-9df3134635f0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Bis[(2-ethyl-1-oxohexyl)oxy]dioctylstannane,24577-34-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/957f6d37-1947-4cb2-867e-49f31447b712/documents/d39cbd1e-09fd-4be7-a844-73d2606315c5_33250ca1-d0b0-405a-b9a8-9df3134635f0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Bis[(3,4-epoxycyclohexyl)methyl] adipate",3130-19-6," Oral: Read-across to structurally similar substance Based on the results of this study, the NOEL for oral administration of the test material to rats for a minimum of 90 days was determined to be 5 mg/kg/day for both males and females. Based on these results, the test material does not require classification according to Directive 67/548/EEC or Regulation 67/548/EEC. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6958f2b-1a54-4864-ab34-52d4d8d503e6/documents/f27d6bb3-c686-4293-85b7-11c1564c9fb2_d0ac4b3d-56b6-42ad-b73e-77102607fce4.html,,,,,, "Bis[(3,4-epoxycyclohexyl)methyl] adipate",3130-19-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6958f2b-1a54-4864-ab34-52d4d8d503e6/documents/f27d6bb3-c686-4293-85b7-11c1564c9fb2_d0ac4b3d-56b6-42ad-b73e-77102607fce4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat "Bis[(3,4-epoxycyclohexyl)methyl] adipate",3130-19-6," Oral Toxicity: Read-across to structurally similar substance, Kern (1999) The results of this study indicate that the LD50 of the test material was found to be approximately 5000 mg/kg in fasted male and female albino rats when administered once orally via gavage. Based on these results, it was not necessary to classify the test material according to Regulation EC No. 1272/2008 or Directive 67/548/EEC. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6958f2b-1a54-4864-ab34-52d4d8d503e6/documents/be5ffb33-e644-4163-84e2-4cd99bdd80db_d0ac4b3d-56b6-42ad-b73e-77102607fce4.html,,,,,, "Bis[(3,4-epoxycyclohexyl)methyl] adipate",3130-19-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6958f2b-1a54-4864-ab34-52d4d8d503e6/documents/be5ffb33-e644-4163-84e2-4cd99bdd80db_d0ac4b3d-56b6-42ad-b73e-77102607fce4.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Bis[[2,2',2''-nitrilotris[ethanolato]](1-)-N,O]bis(propan-2-olato)titanium",36673-16-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39c56846-3f5d-41ed-beb2-4eedec9a9e22/documents/11215e4e-91ca-4587-8057-fa109e53bfd2_8b636942-ecd3-4f4d-928c-84c7c87ab7b5.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Bis[[2,2',2''-nitrilotris[ethanolato]](1-)-N,O]bis(propan-2-olato)titanium",36673-16-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39c56846-3f5d-41ed-beb2-4eedec9a9e22/documents/11215e4e-91ca-4587-8057-fa109e53bfd2_8b636942-ecd3-4f4d-928c-84c7c87ab7b5.html,Chronic toxicity – systemic effects,dermal,NOAEL,250 mg/kg bw/day,,rat "Bis[[2,2',2''-nitrilotris[ethanolato]](1-)-N,O]bis(propan-2-olato)titanium",36673-16-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39c56846-3f5d-41ed-beb2-4eedec9a9e22/documents/11215e4e-91ca-4587-8057-fa109e53bfd2_8b636942-ecd3-4f4d-928c-84c7c87ab7b5.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"12,300 mg/m3",,rat "Bis[[2,2',2''-nitrilotris[ethanolato]](1-)-N,O]bis(propan-2-olato)titanium",36673-16-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39c56846-3f5d-41ed-beb2-4eedec9a9e22/documents/06f1fcf6-468a-43b5-89c9-a7be3fa430ec_8b636942-ecd3-4f4d-928c-84c7c87ab7b5.html,,oral,LD50,"4,190 mg/kg bw",no adverse effect observed, "Bis[[2,2',2''-nitrilotris[ethanolato]](1-)-N,O]bis(propan-2-olato)titanium",36673-16-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39c56846-3f5d-41ed-beb2-4eedec9a9e22/documents/06f1fcf6-468a-43b5-89c9-a7be3fa430ec_8b636942-ecd3-4f4d-928c-84c7c87ab7b5.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Bis[[2,2',2''-nitrilotris[ethanolato]](1-)-N,O]bis(propan-2-olato)titanium",36673-16-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39c56846-3f5d-41ed-beb2-4eedec9a9e22/documents/06f1fcf6-468a-43b5-89c9-a7be3fa430ec_8b636942-ecd3-4f4d-928c-84c7c87ab7b5.html,,inhalation,LC50,"24,600 mg/m3",no adverse effect observed, "Bis[[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthyl]methylene]cyclohexa-2,5-dien-1-ylidene]diethylammonium] dicopper(1+) hexa(cyano-C)ferrate(4-)",82338-76-9," Prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound Bis[[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthyl]methylene] cyclohexa-2,5-dien-1-ylidene] diethylammonium] dicopper(1+) hexa(cyano-C)ferrate(4-)(82338-76-9). The study assumed the use of male and female Crj: CD(SD)rats in chronic study of 90 days . No significant alterations were noted at the dose level of 267.56mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) forBis[[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthyl]methylene]cyclohexa-2,5-dien-1-ylidene]diethylammonium] dicopper(1+) hexa(cyano-C)ferrate(4-is considered to be 267.56mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf9c358f-31df-48fa-a42d-2b0390411c81/documents/f459290d-65d8-46f4-9cb6-760f7c23d487_dae0c078-fa82-4cc7-b632-ee45d5ced280.html,,,,,, "Bis[[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthyl]methylene]cyclohexa-2,5-dien-1-ylidene]diethylammonium] dicopper(1+) hexa(cyano-C)ferrate(4-)",82338-76-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf9c358f-31df-48fa-a42d-2b0390411c81/documents/f459290d-65d8-46f4-9cb6-760f7c23d487_dae0c078-fa82-4cc7-b632-ee45d5ced280.html,Chronic toxicity – systemic effects,oral,NOAEL,267.56 mg/kg bw/day,,rat "Bis[[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthyl]methylene]cyclohexa-2,5-dien-1-ylidene]diethylammonium] dicopper(1+) hexa(cyano-C)ferrate(4-)",82338-76-9," Acute oral toxicity:  Acute oral toxicity dose (LD50) of Bis[[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthyl]methylene]cyclohexa-2,5-dien-1-ylidene]diethylammonium] dicopper(1+) hexa(cyano-C)ferrate(4-) (CAS no: 82338-76-9) was predicted based on OECD QSAR toolbox 5889 mg/kg bw and different studies available on closely related read across substances Terphenyl, hydrogenated (CAS no: 61788-32-7) 17500 mg/kg bw and Benzene, C10-13-alkyl derivs (CAS no: 67774-74-7) > 5000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Bis[[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthyl]methylene] cyclohexa-2,5-dien-1-ylidene]diethylammonium] dicopper(1+) hexa(cyano-C)ferrate(4-) can be classified as category V of acute oral toxicity. Acute Inhalation toxicity:  Bis[[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthyl]methylene]cyclohexa-2,5-dien-1-ylidene]diethylammonium] dicopper(1+) hexa(cyano-C)ferrate(4-) (CAS no: 82338-76-9) has very low vapour pressure 2.9E-26 Pa. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for Bis[[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthyl]methylene]cyclohexa-2,5-dien-1-ylidene]diethylammonium] dicopper(1+) hexa(cyano-C)ferrate(4-) (CAS no: 82338-76-9) was predicted based on OECD QSAR toolbox 6943 mg/kg bwand differentstudies available for the structurally similar read across substance [4-[[4-anilino-1-naphthyl][4-(dimethylamino)phenyl]methylene] cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate (CAS No. 83803-79-6) >2000 mg/kg bw and 4, 4’-carbonimidoylbis [N,N-diethylaniline]mono hydrochloride (CAS No. 6358-36-7) >2000 mg/kg bw. All these studies concluded that the LD50 value is>2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Bis[[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthyl]methylene]cyclohexa-2,5-dien-1-ylidene]diethylammonium] dicopper(1+) hexa(cyano-C)ferrate(4-) can be classified as category V of acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf9c358f-31df-48fa-a42d-2b0390411c81/documents/be22cd86-a3d2-4624-8aab-8bd0f17af48c_dae0c078-fa82-4cc7-b632-ee45d5ced280.html,,,,,, "Bis[[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthyl]methylene]cyclohexa-2,5-dien-1-ylidene]diethylammonium] dicopper(1+) hexa(cyano-C)ferrate(4-)",82338-76-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf9c358f-31df-48fa-a42d-2b0390411c81/documents/be22cd86-a3d2-4624-8aab-8bd0f17af48c_dae0c078-fa82-4cc7-b632-ee45d5ced280.html,,oral,LD50,"5,889 mg/kg bw",no adverse effect observed, "Bis[[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthyl]methylene]cyclohexa-2,5-dien-1-ylidene]diethylammonium] dicopper(1+) hexa(cyano-C)ferrate(4-)",82338-76-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf9c358f-31df-48fa-a42d-2b0390411c81/documents/be22cd86-a3d2-4624-8aab-8bd0f17af48c_dae0c078-fa82-4cc7-b632-ee45d5ced280.html,,dermal,LD50,"6,943 mg/kg bw",no adverse effect observed, bis[2-(2-butoxyethoxy)ethyl] butanedioate,701920-77-6,"Acute dermal toxicity was tested in Spraque-Dawley rats at 5.0 g/kg under occlusive dressing. The acute lethal dermal dose to rats of bis(2 -(2 -(butoxyethoxy)ethyl)butanedioate was found to be greater than 5,0 g/kg bodyweight. No macroscopic abnormalities were observed for animals killed on day 15. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfb0d5ef-794f-4c3d-a10e-2a740b98ce04/documents/IUC5-75940155-9e35-4216-bec5-1a2b8fec53bd_00ad2b77-dda6-45bc-a1cf-855a1293e04c.html,,,,,, bis[2-(2-butoxyethoxy)ethyl] butanedioate,701920-77-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfb0d5ef-794f-4c3d-a10e-2a740b98ce04/documents/IUC5-75940155-9e35-4216-bec5-1a2b8fec53bd_00ad2b77-dda6-45bc-a1cf-855a1293e04c.html,,oral,LD50,"5,838 mg/kg bw",no adverse effect observed, bis[2-(2-butoxyethoxy)ethyl] butanedioate,701920-77-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfb0d5ef-794f-4c3d-a10e-2a740b98ce04/documents/IUC5-75940155-9e35-4216-bec5-1a2b8fec53bd_00ad2b77-dda6-45bc-a1cf-855a1293e04c.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Bis[2-[2-(1-methylethyl)-3-oxazolidinyl]ethyl] hexan-1,2-diylbiscarbamate",59719-67-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): sufficient for assessment Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP study according to guideline. Reliable without restrictions. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d1205554-b122-4fbe-aa27-b2b24b59646c/documents/bc734e77-dd84-42b2-bec0-720f106a63e4_b22c921f-6cb4-48a9-99d8-101016351436.html,,,,,, "Bis[2-[2-(1-methylethyl)-3-oxazolidinyl]ethyl] hexan-1,2-diylbiscarbamate",59719-67-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d1205554-b122-4fbe-aa27-b2b24b59646c/documents/bc734e77-dd84-42b2-bec0-720f106a63e4_b22c921f-6cb4-48a9-99d8-101016351436.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Bis[2-[2-(1-methylethyl)-3-oxazolidinyl]ethyl] hexan-1,2-diylbiscarbamate",59719-67-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d1205554-b122-4fbe-aa27-b2b24b59646c/documents/bc734e77-dd84-42b2-bec0-720f106a63e4_b22c921f-6cb4-48a9-99d8-101016351436.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,500 mg/m3",,mouse "Bis[2-[2-(1-methylethyl)-3-oxazolidinyl]ethyl] hexan-1,2-diylbiscarbamate",59719-67-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Non GLP, but scientifically well documented guideline study. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): GLP study according to guideline. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1205554-b122-4fbe-aa27-b2b24b59646c/documents/8deb7e66-f227-4eb0-9ca5-c56f5d0fb02f_b22c921f-6cb4-48a9-99d8-101016351436.html,,,,,, "Bis[2-[2-(1-methylethyl)-3-oxazolidinyl]ethyl] hexan-1,2-diylbiscarbamate",59719-67-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1205554-b122-4fbe-aa27-b2b24b59646c/documents/8deb7e66-f227-4eb0-9ca5-c56f5d0fb02f_b22c921f-6cb4-48a9-99d8-101016351436.html,,oral,discriminating dose,"5,000 mg/kg bw",adverse effect observed, "Bis[2-[2-(1-methylethyl)-3-oxazolidinyl]ethyl] hexan-1,2-diylbiscarbamate",59719-67-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1205554-b122-4fbe-aa27-b2b24b59646c/documents/8deb7e66-f227-4eb0-9ca5-c56f5d0fb02f_b22c921f-6cb4-48a9-99d8-101016351436.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] adipate,65520-46-9," The test substance is a liquid with a very low vapour pressure, so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols or inhalable droplets, so exposure to humans via the inhalatory route will be unlikely to occur. Results of laboratory animal studies performed with category members show moderate ora toxicity and no dermal toxicity. Effects observed in subchronic oral studies were reduced body weight gain, hepatic hypertrophy and increased peroxisomal enzyme activity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96744cb5-4153-42a9-ae72-6ba2db6ba5c7/documents/IUC5-79ea907e-46af-4e6f-977a-8317065f250a_85a0e0ea-7757-4846-ad11-01210843ad38.html,,,,,, Bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] adipate,65520-46-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96744cb5-4153-42a9-ae72-6ba2db6ba5c7/documents/IUC5-79ea907e-46af-4e6f-977a-8317065f250a_85a0e0ea-7757-4846-ad11-01210843ad38.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,189 mg/kg bw/day,,rat Bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] adipate,65520-46-9," None of the category members has an oral or dermal LD50 < 2000 mg/kg bw. Inhalation effects are not expected among category members, because no exposure is expected basing on the low vapour pressure of the substances. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96744cb5-4153-42a9-ae72-6ba2db6ba5c7/documents/IUC5-30fbb21f-d8ef-4dfc-a469-6fcb1a126ebc_85a0e0ea-7757-4846-ad11-01210843ad38.html,,,,,, Bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] adipate,65520-46-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96744cb5-4153-42a9-ae72-6ba2db6ba5c7/documents/IUC5-30fbb21f-d8ef-4dfc-a469-6fcb1a126ebc_85a0e0ea-7757-4846-ad11-01210843ad38.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] adipate,65520-46-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96744cb5-4153-42a9-ae72-6ba2db6ba5c7/documents/IUC5-30fbb21f-d8ef-4dfc-a469-6fcb1a126ebc_85a0e0ea-7757-4846-ad11-01210843ad38.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] hydrogen glutarate,65520-42-5," The test substance is a liquid with a very low vapour pressure, so the potential for the generation of inhalable forms is low, also the use of this substance will not result in aerosols or inhalable droplets, so exposure to humans via the inhalatory route will be unlikely to occur. Results of laboratory animal studies performed with category members show moderate oral toxicity and no dermal toxicity. Effects observed in subchronic oral studies were reduced body weight gain, hepatic hypertrophy and increased peroxisomal enzyme activity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ef42734-7cad-4009-bf6f-7de436572145/documents/62e9ced4-6da3-4247-9c66-f6321eaa31d9_4ffd5113-bcbc-477f-8fa8-d86e07c50b77.html,,,,,, Bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] hydrogen glutarate,65520-42-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ef42734-7cad-4009-bf6f-7de436572145/documents/62e9ced4-6da3-4247-9c66-f6321eaa31d9_4ffd5113-bcbc-477f-8fa8-d86e07c50b77.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,189 mg/kg bw/day,,rat Bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] hydrogen glutarate,65520-42-5," None of the category members has an oral or dermal LD50 < 2000 mg/kg bw. Inhalation effects are not expected among category members, because no exposure is expected basing on the low vapour pressure of the substances. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ef42734-7cad-4009-bf6f-7de436572145/documents/52bb5976-9465-4fae-8d66-7fd4e7df3bac_4ffd5113-bcbc-477f-8fa8-d86e07c50b77.html,,,,,, Bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] hydrogen glutarate,65520-42-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ef42734-7cad-4009-bf6f-7de436572145/documents/52bb5976-9465-4fae-8d66-7fd4e7df3bac_4ffd5113-bcbc-477f-8fa8-d86e07c50b77.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Bis[2-[2-(2-butoxyethoxy)ethoxy]ethyl] hydrogen glutarate,65520-42-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ef42734-7cad-4009-bf6f-7de436572145/documents/52bb5976-9465-4fae-8d66-7fd4e7df3bac_4ffd5113-bcbc-477f-8fa8-d86e07c50b77.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Bis[3-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)",84000-94-2,LD50(oral) = 560.4 mg/kg bw (based on active ingredient) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd0f61c8-ce4d-4fd2-8208-da192b2f54e1/documents/IUC5-0726b791-a4e0-4fc3-a82e-3ad1d225d03a_d2247f6b-9814-4821-9dd5-c23aa8041039.html,,,,,, "Bis[3-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)",84000-94-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd0f61c8-ce4d-4fd2-8208-da192b2f54e1/documents/IUC5-0726b791-a4e0-4fc3-a82e-3ad1d225d03a_d2247f6b-9814-4821-9dd5-c23aa8041039.html,,oral,LD50,560.4 mg/kg bw,adverse effect observed, "Bis[5-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)",84012-52-2,LD50(oral) = 560.4 mg/kg bw (based on active ingredient) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5678ec46-a327-4686-ae5f-35a04424004f/documents/170357c6-b6b1-4bc4-b55e-83aa452acac7_0b8fd159-f1cd-4e41-9335-291a72e8e372.html,,,,,, "Bis[5-[[4-[benzylmethylamino]phenyl]azo]-1,4-dimethyl-1H-1,2,4-triazolium] tetrachlorozincate(2-)",84012-52-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5678ec46-a327-4686-ae5f-35a04424004f/documents/170357c6-b6b1-4bc4-b55e-83aa452acac7_0b8fd159-f1cd-4e41-9335-291a72e8e372.html,,oral,LD50,560.4 mg/kg bw,adverse effect observed, "Bis[bis(3,5,5-trimethylhexyl)dithiocarbamate-S,S']zinc",84604-96-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de3cf955-68a6-4c90-9717-9303b1f09864/documents/a9cc7f86-0edf-40ac-ab5f-9e0cf03c52fc_8121cfb8-c515-4cff-bde7-a9305a798360.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,6 mg/kg bw/day,,rat "Bis[bis(3,5,5-trimethylhexyl)dithiocarbamate-S,S']zinc",84604-96-6," Acute toxicity was determined via oral and inhalation routes and low toxicity was observed, which did not met the criteria for acute classification ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de3cf955-68a6-4c90-9717-9303b1f09864/documents/120556b4-ded5-4bd3-b63c-c88f089472f3_8121cfb8-c515-4cff-bde7-a9305a798360.html,,,,,, "Bis[O,O-bis(2-ethylhexyl) dithiophosphorato-S,S']dioxodi-μ-thioxodimolybdenum",68958-92-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): guideline conform study ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4611ecc9-fea4-486c-8426-c158a246660f/documents/a139e19c-79ff-4a4a-b1f5-ab4e935227e0_098bf79e-0939-44b4-9607-6162d796e019.html,,,,,, "Bis[O,O-bis(2-ethylhexyl) dithiophosphorato-S,S']dioxodi-μ-thioxodimolybdenum",68958-92-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4611ecc9-fea4-486c-8426-c158a246660f/documents/a139e19c-79ff-4a4a-b1f5-ab4e935227e0_098bf79e-0939-44b4-9607-6162d796e019.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Bis[O,O-bis(2-ethylhexyl) dithiophosphorato-S,S']dioxodi-μ-thioxodimolybdenum",68958-92-9, No animal died after a single oral dose at a level of 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4611ecc9-fea4-486c-8426-c158a246660f/documents/feab2026-e213-4c9c-8038-1a32596326f7_098bf79e-0939-44b4-9607-6162d796e019.html,,,,,, "Bisbenzimidazo[2,1-b:1',2'-j]benzo[lmn][3,8]phenanthroline-6,9-dione",4216-02-8," Oral repeated dose toxicity: An OECD guideline Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test was performed with the Source Substance C.I. Pigment Orange 43.   The test item was administered to the main groups (10 male and 10 female) by oral gavage at dose levels of 0, 100, 300 and 1000 mg/kg Bwt/day. Recovery groups (5 male and 5 females) received dose levels of 0, and 1000 mg/kg Bwt/day. The dose formulations were administered prior to mating, during mating and post-mating periods for males, and prior to mating, during mating, during pregnancy and up to Lactation Day 13 for females. In the control and high dose recovery groups, the treatment period was followed by a 14 day no treatment (recovery) period. Animals in the recovery groups were not mated.   No toxicologically significant changes were noted in any of the parameters investigated in this study (such as clinical signs, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). A No Observed Adverse Effect Level (NOAEL) for the test item for repeated dose toxicity of 1000 mg/kg/day was established. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c429958-19f4-4853-9c69-bb032c3f8019/documents/7549b988-9c4a-400c-b195-c09009c8b122_f21fa377-0595-4df0-8b9e-0a3ef3a5a9f5.html,,,,,, "Bisbenzimidazo[2,1-b:1',2'-j]benzo[lmn][3,8]phenanthroline-6,9-dione",4216-02-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c429958-19f4-4853-9c69-bb032c3f8019/documents/7549b988-9c4a-400c-b195-c09009c8b122_f21fa377-0595-4df0-8b9e-0a3ef3a5a9f5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Bisbenzimidazo[2,1-b:1',2'-j]benzo[lmn][3,8]phenanthroline-6,9-dione",4216-02-8,"Acute oral toxicity: The test item (C.I. Pigment Red 194) did not cause any mortality or clinical signs after single oral gavage administration to 10 female rats at 15 000 mg/kg bw in a valid pre-GLP guideline study according to FDA-guideline, similar to OECD 401.   Acute dermal toxicity: Study was waived and classification for this endpoint is considered unwarranted, because the substance is not likely to become systemically available after dermal exposure and there was no evidence of toxicity observed in any of the endpoints tested.   Acute inhalation toxicity: In an OECD 433 followed study the test item (C.I. Pigment Red 194) did not cause any mortality or clinical signs in rats after single inhalation of 5.02 mg/L air exposure of male rats. Hence the LC50 of the test item is >5.02 mg/L of air.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): reliable without restriction ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c429958-19f4-4853-9c69-bb032c3f8019/documents/a37d5c4e-e980-483b-bd2c-61c1f23df028_f21fa377-0595-4df0-8b9e-0a3ef3a5a9f5.html,,,,,, "Bisbenzimidazo[2,1-b:1',2'-j]benzo[lmn][3,8]phenanthroline-6,9-dione",4216-02-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c429958-19f4-4853-9c69-bb032c3f8019/documents/a37d5c4e-e980-483b-bd2c-61c1f23df028_f21fa377-0595-4df0-8b9e-0a3ef3a5a9f5.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "Bisbenzimidazo[2,1-b:1',2'-j]benzo[lmn][3,8]phenanthroline-6,9-dione",4216-02-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c429958-19f4-4853-9c69-bb032c3f8019/documents/a37d5c4e-e980-483b-bd2c-61c1f23df028_f21fa377-0595-4df0-8b9e-0a3ef3a5a9f5.html,,inhalation,LC50,> 5.02 mg/L,no adverse effect observed, "Bis-biphenyl-4-yl-(9,9‘-spirobifluoren-4-yl)-amine",1450933-43-3,The LD50 value of the test item was determined to be greater than 2000 mg/kg bw after single oral administration in rats.   ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0041fc3-8f7d-43a9-b533-c1698da978bd/documents/01a13329-ddcd-4c5f-8647-2a163a6f1495_7198174a-5c7f-4317-a0e4-ae53ee096441.html,,,,,, "Bis-biphenyl-4-yl-(9,9‘-spirobifluoren-4-yl)-amine",1450933-43-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0041fc3-8f7d-43a9-b533-c1698da978bd/documents/01a13329-ddcd-4c5f-8647-2a163a6f1495_7198174a-5c7f-4317-a0e4-ae53ee096441.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Bisdecanoyl peroxide,762-12-9," For this endpoint, no experimental study on didecanoyl peroxide is available. Nevertheless, it is proposed to use data from an analogous substance which has very close physico-chemical and toxicological properties. . The potential effect of dilauroyl peroxide following repeated oral gavage was evaluated in rats in an OECD 407 study conducted in accordance with the GLP (Braun, 2010). Wistar rats were administered 0, 100, 300 and 1000 mg/kg/day of the test substance for 28 days. Test item-related finding were restricted to reduces body weights in males and females at 1000 mg/kg/day only. Based on this slight decrease of body weight, the NOEL was 300 mg/kg/day and the NOAEL was 1000 mg/kg/day. An OECD TG #408 study was designed to investigate the systemic toxicity of the test item, dilauryl peroxide (Dunster, 2013). The test item was administered daily by gavage to three groups, each of ten male and ten female Wistar rats, for ninety consecutive days, at dose levels of 100, 300 and 1000 mg/kg bw/day. A control group of ten males and ten females was dosed with vehicle alone (Corn oil). Clinical signs, functional observations, body weight change, dietary intake and water consumption were monitored during the study. Hematology and blood chemistry were evaluated for all animals at the end of the study. Ophthalmoscopy examination was also performed on control group and high dose animals. All animals were subjected to gross necropsy examination and histopathological evaluation of selected tissues from high dose and control animals was performed. There were no unscheduled deaths and clinical signs during the study. There were no treatment-related changes in behavioral parameters measured. There were no treatment-related changes in functional performance and sensory reactivity. No adverse effects were detected in body weight gain, in overall food consumption or food efficiency and in water consumption in treated animals when compared to controls. There were no treatment related ocular effects detected. There were no treatment-related effects on female estrous cycles or on the type or proportion of females with anomalous estrous cycles. There were no toxicologically significant effects detected in the hematological and blood chemical parameters examined. There were no toxicologically significant macroscopic abnormalities detected. No toxicologically significant effects were detected in the organ weights examined. No treatment related microscopic abnormalities were detected. There were no treatment-related effects on the concentration or motility of samples of epididymal sperm. The oral administration of dilauroyl peroxide to rats by gavage, at dose levels of 100, 300 and 1000 mg/kg bw/day, did not result in any toxicologically significant effects. The ‘No Observed Adverse Effect Level’ (NOAEL) was therefore considered to be 1000 mg/kg bw/day. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b7da296-5fad-4231-a6e9-2454af781bc9/documents/IUC5-eab94116-ed8e-4844-b2c7-62b32076a338_73f90b9e-7fca-4d87-8fb9-f5f2dce4da0b.html,,,,,, Bisdecanoyl peroxide,762-12-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b7da296-5fad-4231-a6e9-2454af781bc9/documents/IUC5-eab94116-ed8e-4844-b2c7-62b32076a338_73f90b9e-7fca-4d87-8fb9-f5f2dce4da0b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Bisdecanoyl peroxide,762-12-9," Acute oral toxicity In an acute oral toxicity test the substance was given by gavage as a 50 % (w/v) solution in Shellsol T to groups of 10 male and female Wistar rats (Til, 1979). There were very few details on the substance and no individual records. Nevertheless the study was sufficient for acute oral toxicity assessment. The animals received 10 ml per kg, therefore approximately 5000 mg/kg didecanoyl peroxide of body weight. Following treatment, rats were observed frequently following hours after treatment. Thereafter, they were observed daily. The rats were weighted the day of treatment after an overnight fasting. A necropsy examination was performed at the time of scheduled euthanasia (14 days after substance test administration). No deaths occurred during the study. But within a few hours after dosing the rats showed sluggishness, humpback behaviour, and sever diarrhoea. Signs of unthriftiness were observed throughout the first few post-treatment days. Then rats recovered gradually and looked quite healthy at the end of observation period. Moreover macroscopic examination of the survivor did not reveal any treatment-related gross alterations.The LD0 was > 5000 mg/kg. Acute dermal toxicity The acute dermal toxicity of didecanoyl peroxide (purity: 99.1 %) was evaluated in rats according to OECD N° 402 guideline (Manciaux, 1998). No deaths occurred during the study. No clinical signs and no cutaneous reactions were observed. The body weight gain was lower for one female during the period of day 1 to day 8, and for another female during the period of day 8 to day 15. Necropsy after death revealed no abnormalities. The LD0 was > 2000 mg/kg. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b7da296-5fad-4231-a6e9-2454af781bc9/documents/IUC5-b1ec5288-8dbf-470a-b1c0-fa076f271ecd_73f90b9e-7fca-4d87-8fb9-f5f2dce4da0b.html,,,,,, Bisdecanoyl peroxide,762-12-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b7da296-5fad-4231-a6e9-2454af781bc9/documents/IUC5-b1ec5288-8dbf-470a-b1c0-fa076f271ecd_73f90b9e-7fca-4d87-8fb9-f5f2dce4da0b.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Bisdecanoyl peroxide,762-12-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b7da296-5fad-4231-a6e9-2454af781bc9/documents/IUC5-b1ec5288-8dbf-470a-b1c0-fa076f271ecd_73f90b9e-7fca-4d87-8fb9-f5f2dce4da0b.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bisguanidinium phosphate,5423-23-4," Key, repeated oral dose toxicity, rat, GLP, OECD 422 (Szakonyiné, 2021): NOAEL male: 50 mg/kg bw/day, NOAEL female rats: 100 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21ef243f-82dd-4590-a08e-71c678f5f2c3/documents/19663017-f10f-4cd0-9130-24c561837af9_885afef7-41f2-41da-b5f1-f694fbba9e7a.html,,,,,, Bisguanidinium phosphate,5423-23-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21ef243f-82dd-4590-a08e-71c678f5f2c3/documents/19663017-f10f-4cd0-9130-24c561837af9_885afef7-41f2-41da-b5f1-f694fbba9e7a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Bisguanidinium phosphate,5423-23-4," Acute toxicity oral: Kuthy, 2019: Key study, OECD TG 423, Acute Toxic Class method, rat, LD50 = 500 mg/kg bw dermal: Kuthy, 2020: Key study, OECD TG 402, Acute Dermal Toxicity, rat, LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21ef243f-82dd-4590-a08e-71c678f5f2c3/documents/4752e62e-2701-494d-b66c-8b5d839a5558_885afef7-41f2-41da-b5f1-f694fbba9e7a.html,,,,,, Bisguanidinium phosphate,5423-23-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21ef243f-82dd-4590-a08e-71c678f5f2c3/documents/4752e62e-2701-494d-b66c-8b5d839a5558_885afef7-41f2-41da-b5f1-f694fbba9e7a.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Bisguanidinium phosphate,5423-23-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21ef243f-82dd-4590-a08e-71c678f5f2c3/documents/4752e62e-2701-494d-b66c-8b5d839a5558_885afef7-41f2-41da-b5f1-f694fbba9e7a.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Bisisobutyryl peroxide,3437-84-1," Introduction The study was designed to investigate the systemic toxicity of the test item and is compatible with the following regulatory guidelines: i)       The OECD Guidelines for Testing of Chemicals No. 408 ""Subchronic Oral Toxicity - Rodent: 90 Day Study” (Adopted 21 September 1998). This study was also designed to be compatible with Commission Regulation (EC) No 440/2008 of 30 May 2008, laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). The study design also took into account elements from the following guideline: ·        In vivoMammalian Alkaline Comet Assay” (Adopted 26 September 2014) Methods The test item was administered by oral gavage to three groups of ten male and ten female Wistar Han™:HsdRccHan™:WIST strain rats, at dose levels of 10, 100 or 200/300 mg/kg bw/day. Animals from the high dose group were dosed at 200 mg/kg bw/day up to Day 30 (females) or Day 31 (males) with the dose level increased to 300 mg/kg bw/day thereafter; as these animals were dosed at 300 mg/kg bw/day for approximately 2/3 of the dosing period, the dose level for this group will generally be referred to as 300 mg/kg bw/day throughout this study report. A control group of ten males and ten females was dosed with the vehicle alone (Arachis oil BP). Two recovery groups, each of ten males and ten females, were treated with the high dose (200/300 mg/kg bw/day) or the vehicle alone for ninety consecutive days and then maintained without treatment for a further twenty-eight days. The first five males from each non-recovery dose group (Groups 1 to 4) were dosed for ninety-one consecutive days whilst the remaining males and females from these dose groups were dosed for ninety consecutive days. An additional group of five males (Group 5), used as positive control for comet assay assessment, was administered with 25 mg/kg bw/day N-Nitroso-N-methylurea by oral gavage on Days 90 and 91. Animals treated on Days 90 and 91 were dosed approximately twenty-seven and three hours (respectively) before euthanasia and selected tissues from these animals were used for comet assay assessment. Clinical signs, functional observations, body weight change and dietary intake were monitored during the study. Hematology and blood chemistry were evaluated for all Groups 1 to 4 animals at the end of treatment and treatment-free periods. Urinalysis was performed for all Groups 1 to 4 non-recovery animals during Week 12 of dosing and for all recovery animals during the last week of the treatment-free period. Ophthalmoscopic examination was also performed on all Groups 1 to 4 animals prior to the start of treatment and on all non-recovery control and high dose animals during Week 12 of the study. Additionally, the stage of estrous was monitored for all non-recovery females during the last three weeks of the treatment period. All animals were subjected to gross necropsy examination and histopathological evaluation of selected tissues from all non-recovery control and high dose animals (Groups 1 and 4) as well as any gross lesions from Groups 1 to 4 animals was performed in the first instance. As there were treatment-related findings in the kidneys (males only) and the stomach (males and females), examination of these tissues was subsequently extended to include relevant animals from the low and intermediate dose groups as well as recovery groups. Results Mortality There were no unscheduled deaths during the study. Clinical Observations Throughout the treatment period, there were no clinical signs indicative of test item toxicity. Behavioral Assessment Behavioral assessment scores across the test-item treated animals of either sex remained similar to controls. Functional Performance Tests There were no treatment-related changes in functional performance for animals of either sex at any dose level. Sensory Reactivity Assessments Sensory reactivity scores were comparable across all dose groups including controls. Body Weight There was no adverse effect of treatment with the test item at any dose level on body weight development in animals of either sex. Overall body weight gain in non-recovery males treated with 300 mg/kg bw/day was approximately 13% lower than control at the end of dosing, but recovery was evident during the treatment-free period, and this finding was deemed to be related to irritant properties of the test item and not an indication of its systemic toxicity. Food Consumption There was no adverse effect of treatment with the test item at any dose level on food consumption or food conversion efficiency in animals of either sex. Marginally lower dietary intake in males treated with 300 mg/kg bw/day from Week 6 of dosing was considered to be due to irritant properties of the test item rather than an indication of its systemic toxicity. Water Consumption When compared with controls, visual inspection of water bottles did not reveal any intergroup differences in animals of either sex receiving the test item. Estrous Cycling There was no adverse effect of treatment with the test item at any dose level on the nature of estrous cycle with most females showing regular cycles over the last three weeks of dosing. Ophthalmoscopy Ophthalmoscopic examination of non-recovery males and females from the control and 300 mg/kg bw/day dose groups during Week 12 of dosing did not reveal any treatment-related differences. Hematology Hematology evaluations at the end of the treatment or treatment-free periods did not reveal any toxicologically significant effects in animals of either sex resulting from treatment with the test item. Blood Chemistry Blood chemistry evaluations at the end of the treatment or treatment-free periods did not indicate any effects of toxicological relevance in animals of either sex resulting from test item administration. Urinalysis Urinalytical evaluations did not identify any treatment-related effects in males or females receiving the test item up to a dose level of 300 mg/kg bw/day. Necropsy There were no macroscopic observations at terminal necropsy considered to be related to treatment with the test item. Sperm Analysis At the end of the treatment or treatment-free periods, sperm concentration, motility and progressive motility across all test item-treated male dose groups were similar to controls. Morphological sperm assessment also did not identify any treatment-related differences between non-recovery males from the control and 300 mg/kg bw/day dose groups. Organ Weights Increased kidney weights in non-recovery males from the 300 mg/kg bw/day dose groups, which persisted in the recovery males previously receiving 300 mg/kg bw/day albeit to a lower extent, were considered to be associated with α-2u-globulin nephropathy syndrome in these males. The increase in liver weights observed in non-recovery animals of either sex receiving 300 mg/kg bw/day and females treated with 100 mg/kg bw/day showed complete reversibility in recovery animals and was not associated with any histopathology findings. Histopathology Treatment-related findings were recorded in the kidneys of males and the stomach of males and females. Some of the changes in the kidneys persisted after the twenty-eight day recovery period but the changes in the stomach had resolved. The histopathology findings were as following: Kidneys At the end of the dose administration period, hyaline droplets were present in males treated with 100 or 300 mg/kg bw/day. Multifocal basophilic tubules and proteinacious casts were also observed in these males. Immunohistochemical staining was positive for α-2u-globulin in males from all groups with an indication of increased staining levels in males treated with 100 or 300 mg/kg bw/day. At the end of the recovery phase, males previously treated with 300 mg/kg bw/day still showed proteinaceous casts and chronic nephropathy (basophilic tubules, fibrosis, tubular atrophy, tubular dilation). Immunohistochemical staining was positive for α-2u-globulin in all recovery males with males previously receiving 300 mg/kg bw/day showing increased staining levels relative to controls. Stomach At the end of the dosing period, minimal hyperplasia of the non-glandular region was noted in most males and some females treated with 300 mg/kg bw/day. This change had resolved after the recovery period. Conclusion Excluding the findings from the comet assay assessment, the oral (gavage) administration of bisisobutyryl peroxide (CAS# 3437-84-1) to male and female Wistar Han™:RccHan™:WIST strain rats at dose levels of 10, 100 or 300 mg/kg bw/day was well tolerated. There were no findings of toxicological significance in animals of either sex and a dose level of 300 mg/kg bw/day could therefore be established as a ‘No Observed Adverse Effect Level’ (NOAEL) for general systemic toxicity within the confines of this type of study (OECD 408). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d4395dc-45b2-43db-b263-3072bc49ee03/documents/IUC5-f9027992-7646-46ca-b6a9-0287020bb55f_add109da-8545-42f7-97d5-881d43eac6fc.html,,,,,, Bisisobutyryl peroxide,3437-84-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d4395dc-45b2-43db-b263-3072bc49ee03/documents/IUC5-f9027992-7646-46ca-b6a9-0287020bb55f_add109da-8545-42f7-97d5-881d43eac6fc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Bisisobutyryl peroxide,3437-84-1," The acute oral toxicity of diisobutyryl peroxide 30% was determined in rats. The test substance was given to groups of 5 males and 5 females in one single dose of 2000 mg per kg body weight. At 1 hour after treatment all animals showed moderate signs of sluggishness and piloerection. At 4 hours after treatment all animals showed moderate signs of diarrhoea. Signs of sluggishness and piloerection were not observed 4 hours after treatment. Signs of diarrhoea were not observed 24 hours after treatment. All animals gained weight after 3 days and thereafter, and no mortality occurred, however in most females a growth delay was observed. In most female animals a comparatively small stomach was observed at macroscopic examination at the end of the observation period, the other animals did not reveal any treatment-related gross alteration. The oral LD50 of the test substance was found to exceed 2000 mg per kg body weight, both in male and female rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d4395dc-45b2-43db-b263-3072bc49ee03/documents/IUC5-8f7c2cad-5632-4b81-8811-1906fcd7665f_add109da-8545-42f7-97d5-881d43eac6fc.html,,,,,, Bisisobutyryl peroxide,3437-84-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d4395dc-45b2-43db-b263-3072bc49ee03/documents/IUC5-8f7c2cad-5632-4b81-8811-1906fcd7665f_add109da-8545-42f7-97d5-881d43eac6fc.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Bisisopropyl peroxydicarbonate,105-64-6,"Repeated dose toxicity (OECD 422, Kr.1): the NOAEL for parental toxicity was considered to be 150 mg/kg bw/day, based on the absence of adverse findings at this high-dose level.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/081a7205-2066-48be-af50-d3b1c3f4e08d/documents/4642bd82-e221-4735-920e-8082ded98b67_af748b2e-d28e-476e-87f2-a3f4166ba173.html,,,,,, Bisisopropyl peroxydicarbonate,105-64-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/081a7205-2066-48be-af50-d3b1c3f4e08d/documents/4642bd82-e221-4735-920e-8082ded98b67_af748b2e-d28e-476e-87f2-a3f4166ba173.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Bisisopropyl peroxydicarbonate,105-64-6,"Oral route The single dose, oral LD50 of pure Isopropyl Percarbonate for male, albino rats is 2140 mg/kg. with 95% confidence limits of 1380 to 3320 mg/kg. Survivors of the exposure exhibited no sign of residual chemical effects (McNerney, 1961). This value is supported by a rat oral LD50 of 2400 mg/kg with a reliability index of 0.8 estimated by the Danish QSAR database.   Inhalation exposure A 60-minute exposure to the fog and vapors of a 45% solution of bisisopropyl peroxydicarbonate in Soltrol 130 (ca 15 mg/L of bisisopropyl peroxydicarbonate) caused a 50% mortality in a group of six male albino rats, during the exposure and in the 25 minutes after exposure (McNervey, 1961). The apparent cause of death was anoxia due to hemorrhagic pulmonary edema. Pulmonary sequelae that appeared in the 24 hours after the exposure, seemed to disappear in72 hours. Six male albino rats survived an exposure of 30 minutes. Scattered foci of pneumonia existed immediately after exposure, but were resorbed within 24 hours. A 10-minute exposure did not result in death or grossly significant injury in a group of six albino rats males. All rats exhibited symptoms of respiratory disorders during the exposure, the intensity of the reaction being directly related to the duration of the exposure.   No symptoms of abnormality and histopathological changes in lungs were noted during a 8-hour inhalation exposure to saturated vapor concentration of bisisopropyl peroxydicarbonate and/or its degradation products (Lalich, 1958).   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/081a7205-2066-48be-af50-d3b1c3f4e08d/documents/2928c551-03c7-413b-8fea-6fd4c2c4bb6f_af748b2e-d28e-476e-87f2-a3f4166ba173.html,,,,,, Bisisopropyl peroxydicarbonate,105-64-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/081a7205-2066-48be-af50-d3b1c3f4e08d/documents/2928c551-03c7-413b-8fea-6fd4c2c4bb6f_af748b2e-d28e-476e-87f2-a3f4166ba173.html,,oral,LD50,"2,140 mg/kg bw",no adverse effect observed, Bismuth,7440-69-9,Repeated dose toxicity via the oral route: NOAEL of bismuth was determined to be 1000 mg/kg for male and female rats in a subacute toxicity study. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1d8933e3-9db4-4860-822d-8c5a6b8e122e/documents/IUC5-3303d320-c044-4e7a-9adc-660c3b371464_13006a16-5202-4cf3-80ec-b31165448a6c.html,,,,,, Bismuth,7440-69-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1d8933e3-9db4-4860-822d-8c5a6b8e122e/documents/IUC5-3303d320-c044-4e7a-9adc-660c3b371464_13006a16-5202-4cf3-80ec-b31165448a6c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Bismuth,7440-69-9,"Bismuth metal is not acutely toxic via oral, dermal or inhalation route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d8933e3-9db4-4860-822d-8c5a6b8e122e/documents/IUC5-dec6de07-ed42-4fdb-9cb8-b0efd185caef_13006a16-5202-4cf3-80ec-b31165448a6c.html,,,,,, Bismuth oxide salicylate,14882-18-9,"A repeated dose toxicity study with read across substance, methylsalicylate, was conducted in dogs for 2 years. Dogs of the 150 and 350 mg/kg groups had retarded growth and enlarged livers. No effects were reported at 50 mg/kg bw/day. Based on this study, the NOAEL /oral/dogs is 50 mg/kg body weight/day. The NOAEL was determined to be 1000 mg/kg bw/day for male and female rats in a 90 day repeated dose study (OECD 408) via the oral route with read-across substance, bismuth subnitrate.Read-across substance, methyl salicylate, showed no evidence of toxicity by inhalation when tested at a concentration of 700 mg/m3 (effectively saturated) for 7 hours per day for four weeks in rats.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7abefedb-aea6-413d-8008-5ba0601dfd75/documents/IUC5-51bb2e42-7515-4397-bd28-08b506e81e18_fa5d4011-b20b-4c43-93ab-a375f0bc0a2c.html,,,,,, Bismuth oxide salicylate,14882-18-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7abefedb-aea6-413d-8008-5ba0601dfd75/documents/IUC5-51bb2e42-7515-4397-bd28-08b506e81e18_fa5d4011-b20b-4c43-93ab-a375f0bc0a2c.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,700 mg/m3,,rat Bismuth oxide salicylate,14882-18-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7abefedb-aea6-413d-8008-5ba0601dfd75/documents/IUC5-51bb2e42-7515-4397-bd28-08b506e81e18_fa5d4011-b20b-4c43-93ab-a375f0bc0a2c.html,Chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Bismuth oxide salicylate,14882-18-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7abefedb-aea6-413d-8008-5ba0601dfd75/documents/IUC5-51bb2e42-7515-4397-bd28-08b506e81e18_fa5d4011-b20b-4c43-93ab-a375f0bc0a2c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,700 mg/m3,no adverse effect observed,rat Bismuth oxide salicylate,14882-18-9,"Bismuth subsalicylate is not acutely toxic via the oral route. By read across, bismuth subsalicylate is not acutely toxic via the inhalation route or the dermal route.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7abefedb-aea6-413d-8008-5ba0601dfd75/documents/IUC5-518a98ce-7db1-4c3b-bea3-09d2ccb15181_fa5d4011-b20b-4c43-93ab-a375f0bc0a2c.html,,,,,, Bismuth oxide salicylate,14882-18-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7abefedb-aea6-413d-8008-5ba0601dfd75/documents/IUC5-518a98ce-7db1-4c3b-bea3-09d2ccb15181_fa5d4011-b20b-4c43-93ab-a375f0bc0a2c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Bismuth oxide salicylate,14882-18-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7abefedb-aea6-413d-8008-5ba0601dfd75/documents/IUC5-518a98ce-7db1-4c3b-bea3-09d2ccb15181_fa5d4011-b20b-4c43-93ab-a375f0bc0a2c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Bismuth oxide salicylate,14882-18-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7abefedb-aea6-413d-8008-5ba0601dfd75/documents/IUC5-518a98ce-7db1-4c3b-bea3-09d2ccb15181_fa5d4011-b20b-4c43-93ab-a375f0bc0a2c.html,,inhalation,LC50,"5,070 mg/m3",no adverse effect observed, Bismuth trihydroxide,10361-43-0,"The NOAEL was determined to be 1000 mg/kg bw/day for male and female rats in a 90 day repeated dose study (OECD 408) via the oral route with read-across substance, bismuth subnitrate. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4eca6318-0e4e-4446-bbda-a9a359e20dd2/documents/IUC5-c69bf51d-8440-4f9f-a04e-198d80fcb93c_656aa454-b076-4eb2-bf94-964280ebbf83.html,,,,,, Bismuth trihydroxide,10361-43-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4eca6318-0e4e-4446-bbda-a9a359e20dd2/documents/IUC5-c69bf51d-8440-4f9f-a04e-198d80fcb93c_656aa454-b076-4eb2-bf94-964280ebbf83.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Bismuth trihydroxide,10361-43-0,"By read across to bismuth subsalicylate, bismuth hydroxide is not acutely toxic via the oral route. By read across to dibismuth trioxide, bismuth hydroxide is not acutely toxic via the inhalation route. Acute toxicity via the dermal route was not tested. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4eca6318-0e4e-4446-bbda-a9a359e20dd2/documents/IUC5-9a0e90fb-e76f-4d74-997d-a14f23b56b09_656aa454-b076-4eb2-bf94-964280ebbf83.html,,,,,, Bismuth trihydroxide,10361-43-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4eca6318-0e4e-4446-bbda-a9a359e20dd2/documents/IUC5-9a0e90fb-e76f-4d74-997d-a14f23b56b09_656aa454-b076-4eb2-bf94-964280ebbf83.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Bismuth trihydroxide,10361-43-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4eca6318-0e4e-4446-bbda-a9a359e20dd2/documents/IUC5-9a0e90fb-e76f-4d74-997d-a14f23b56b09_656aa454-b076-4eb2-bf94-964280ebbf83.html,,inhalation,LC50,"5,070 mg/m3",no adverse effect observed, Bismuth trinitrate,10361-44-1," In conclusion, although no systemic toxicity is seen after treatment up to 1000 mg/kg for 90-days, based on mortality and the local test item-related morphologic alterations in the stomach of males and females, a NOAEL of 300 mg/kg was established. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d32fc8f7-a581-418a-b380-c3b326003bfb/documents/84f38da7-04ea-4c46-a91b-1c2364c71fe4_96d4e0cb-7cd8-494a-8007-a356d8d46c73.html,,,,,, Bismuth trinitrate,10361-44-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d32fc8f7-a581-418a-b380-c3b326003bfb/documents/84f38da7-04ea-4c46-a91b-1c2364c71fe4_96d4e0cb-7cd8-494a-8007-a356d8d46c73.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Bismuth trinitrate,10361-44-1,"By read across to bismuth subsalicylate, bismuth trinitrate is not acutely toxic via the oral route. By read across to dibismuth trioxide, bismuth trinitrate is not acutely toxic via the inhalation route. Acute toxicity via the dermal route was not tested. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d32fc8f7-a581-418a-b380-c3b326003bfb/documents/5d8959e7-644e-4949-b1f0-6c0232c1f38e_96d4e0cb-7cd8-494a-8007-a356d8d46c73.html,,,,,, Bismuth trinitrate,10361-44-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d32fc8f7-a581-418a-b380-c3b326003bfb/documents/5d8959e7-644e-4949-b1f0-6c0232c1f38e_96d4e0cb-7cd8-494a-8007-a356d8d46c73.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Bismuth trinitrate,10361-44-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d32fc8f7-a581-418a-b380-c3b326003bfb/documents/5d8959e7-644e-4949-b1f0-6c0232c1f38e_96d4e0cb-7cd8-494a-8007-a356d8d46c73.html,,inhalation,LC50,"5,070 mg/m3",no adverse effect observed, Bismuth tris(2-ethylhexanoate),67874-71-9," No repeated dose toxicity study with bismuth tris (2-ethylhexanoate) is available, thus the repeated dose toxicity will be addressed with existing data on the individual assessment entities bismuth and 2-ethylhexanoate. In relevant and reliable repeated dose toxicity studies for both assessment entities of bismuth tris (2-ethylhexanoate), there were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/28552ea1-b8ac-4167-b551-291d393640c9/documents/10ed4782-9f53-4ba5-ab48-2cb6f0e2f74b_33409590-71c0-4208-a3d8-22006810d8c8.html,,,,,, Bismuth tris(2-ethylhexanoate),67874-71-9,"The experimentally measured oral LD50 for bismuth tris(2-ethylhexanoate) is > 2000 mg/kg bw, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral toxicity as well as for specific target organ toxicity, single exposure (STOT SE). The assessment entity 2 -ethylhexanoic acid has not shown signs of acute dermal toxicity in experimental testing. The assessment entity bismuth is assumed not to show any signs of acute toxicity upon dermal exposure, due to its very poor percutaneous absorption. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28552ea1-b8ac-4167-b551-291d393640c9/documents/2298c73e-73f8-4a5a-a796-0b30731f5ca4_33409590-71c0-4208-a3d8-22006810d8c8.html,,,,,, Bismuth tris(2-ethylhexanoate),67874-71-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28552ea1-b8ac-4167-b551-291d393640c9/documents/2298c73e-73f8-4a5a-a796-0b30731f5ca4_33409590-71c0-4208-a3d8-22006810d8c8.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Bismuth vanadium tetraoxide,14059-33-7," Three inhalation studies and one oral study are available. Rats were exposed in a 28 day study (similar to OECD guideline 412) to 2, 8, and 80 mg/m3 of the test substance and observed for up to 12 month post exposure. A 90 day study (according to OECD guideline 413) with rats and 0.1, 0.7 and 4 mg/m3 yielded the NOAEC. A non-guideline two-week study with exposure to 1.2 and 0.11 mg/L of uncoated BiVO4, 1.3 and 0.15 mg/L silica coated BiVO4 or silica coated TiO2 (1.9 mg/L) with a post-exposure time of up to 12 months. In a second experiment, rats were exposed to 1.2 mg/L BiVO4 for two weeks and observed for 6 months until scheduled sacrifice. All studies revealed that the target organ is the lung, systemic toxicity was not observed. In addition, rats were exposed by gavage to 40, 200, 100 mg/kg bw/day for 28 days with a protocol similar to OECD guideline 407. Again, systemic toxicity was not observed but females of the highest dose group revealed necrosis of the glandular stomach. This local effect used to set the NOAEL of this study at 200 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9f6b496-d42e-4367-925e-6e263d0ef7a9/documents/19bbc801-2d6f-43c8-b950-63d34ea71f63_2a59267f-af31-4cb5-b6aa-90952884bc64.html,,,,,, Bismuth vanadium tetraoxide,14059-33-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9f6b496-d42e-4367-925e-6e263d0ef7a9/documents/19bbc801-2d6f-43c8-b950-63d34ea71f63_2a59267f-af31-4cb5-b6aa-90952884bc64.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Bismuth vanadium tetraoxide,14059-33-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9f6b496-d42e-4367-925e-6e263d0ef7a9/documents/19bbc801-2d6f-43c8-b950-63d34ea71f63_2a59267f-af31-4cb5-b6aa-90952884bc64.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.1 mg/m3,,rat Bismuth vanadium tetraoxide,14059-33-7," Two acute oral (similar to OECD guideline 401) and one inhalation study (similar to OECD guideline 403) are available. No relevant clinical symptoms were noted. Mortality did not occur. The oral LD50 was determined in excess of 5000 mg/kg bw, the LC50 was > 5.15 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9f6b496-d42e-4367-925e-6e263d0ef7a9/documents/01e266e6-f7ed-46b0-bc3a-b0478789e4dd_2a59267f-af31-4cb5-b6aa-90952884bc64.html,,,,,, Bismuth vanadium tetraoxide,14059-33-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9f6b496-d42e-4367-925e-6e263d0ef7a9/documents/01e266e6-f7ed-46b0-bc3a-b0478789e4dd_2a59267f-af31-4cb5-b6aa-90952884bc64.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Bismuth vanadium tetraoxide,14059-33-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9f6b496-d42e-4367-925e-6e263d0ef7a9/documents/01e266e6-f7ed-46b0-bc3a-b0478789e4dd_2a59267f-af31-4cb5-b6aa-90952884bc64.html,,inhalation,discriminating conc.,"5,150 mg/m3",no adverse effect observed, Bismuth(3+) neodecanoate,34364-26-6,"No repeated dose toxicity study with bismuth(3+) neodecanoate is available, thus the repeated dose toxicity will be addressed with existing data on the individual moieties bismuth and neodecanoate. In relevant and reliable repeated dose toxicity studies for both moieties of bismuth(3+) neodecanoate, there were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a4a31fa-06d3-4772-a6ca-9e1a4556f4ca/documents/77dea158-76c6-4a6e-89af-8721f648375b_11215f0a-d28e-4c55-b14f-3ab8c981bb8b.html,,,,,, Bismuth(3+) neodecanoate,34364-26-6,"In a GLP conform OECD 423 study, the acute oral LD50 value of the test item bismuth(3+) neodecanoate was found to be 300 < LD50 ≤ 2000 mg/kg bw in female Han:WIST rats. No adverse effects were observed in an acute dermal toxicity study conducted with a mixture of bismuth neodecanoate and neodecanoic acid. These conclusions correspond with the results of in vivo oral and dermal LD50 data on the assessment entities bismuth and neodecanoate. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a4a31fa-06d3-4772-a6ca-9e1a4556f4ca/documents/94eb135d-0696-4afa-8a7e-d2adaaaf0f5e_11215f0a-d28e-4c55-b14f-3ab8c981bb8b.html,,,,,, Bismuth(3+) neodecanoate,34364-26-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a4a31fa-06d3-4772-a6ca-9e1a4556f4ca/documents/94eb135d-0696-4afa-8a7e-d2adaaaf0f5e_11215f0a-d28e-4c55-b14f-3ab8c981bb8b.html,,oral,LD50,ca.500 mg/kg bw,adverse effect observed, Bismuth(3+) neodecanoate,34364-26-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a4a31fa-06d3-4772-a6ca-9e1a4556f4ca/documents/94eb135d-0696-4afa-8a7e-d2adaaaf0f5e_11215f0a-d28e-4c55-b14f-3ab8c981bb8b.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Black HM 2482,89857-06-7,NOAEL (oral; sub-acute; rat) = 200 mg/kg bw/day NOAEL (dermal; sub-acute; rat) = 1000 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05a12c87-6973-4cd8-8ea9-0b7e445e136c/documents/1bab8dc5-cf53-4ddd-a7fb-fc29ad3601f9_157a3107-dbe5-4d6e-9803-0577d6a4d009.html,,,,,, Black HM 2482,89857-06-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05a12c87-6973-4cd8-8ea9-0b7e445e136c/documents/1bab8dc5-cf53-4ddd-a7fb-fc29ad3601f9_157a3107-dbe5-4d6e-9803-0577d6a4d009.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Black HM 2482,89857-06-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05a12c87-6973-4cd8-8ea9-0b7e445e136c/documents/1bab8dc5-cf53-4ddd-a7fb-fc29ad3601f9_157a3107-dbe5-4d6e-9803-0577d6a4d009.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 ",, Black HM 2482,89857-06-7,"LD50 (oral) > 5000 mg/kg bw (rat, male and female)LD50 (dermal) > 2000 mg/kg bw (rat, male and female) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05a12c87-6973-4cd8-8ea9-0b7e445e136c/documents/c3233cf1-5b55-4199-9b23-502441b6dec7_157a3107-dbe5-4d6e-9803-0577d6a4d009.html,,,,,, Black HM 2482,89857-06-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05a12c87-6973-4cd8-8ea9-0b7e445e136c/documents/c3233cf1-5b55-4199-9b23-502441b6dec7_157a3107-dbe5-4d6e-9803-0577d6a4d009.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Black HM 2482,89857-06-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05a12c87-6973-4cd8-8ea9-0b7e445e136c/documents/c3233cf1-5b55-4199-9b23-502441b6dec7_157a3107-dbe5-4d6e-9803-0577d6a4d009.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Boehmite (Al(OH)O),1318-23-6,"Based on read-acrossOral: NOAEL (chronic, rat) 30 mg Al/kg bw/day as aluminium citrate.Inhalation: NOAEC (subchronic, rat) 70 mg Al/m³ as aluminium oxide. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a060b186-0798-4169-bfb3-8be779a72fe5/documents/IUC5-661cde0c-e4ee-4d2c-b6ee-1c6958cf3686_87323017-7128-4839-9d2a-c99e2137d707.html,,,,,, Boehmite (Al(OH)O),1318-23-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a060b186-0798-4169-bfb3-8be779a72fe5/documents/IUC5-661cde0c-e4ee-4d2c-b6ee-1c6958cf3686_87323017-7128-4839-9d2a-c99e2137d707.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,70 mg/m3,,rat Boehmite (Al(OH)O),1318-23-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a060b186-0798-4169-bfb3-8be779a72fe5/documents/IUC5-661cde0c-e4ee-4d2c-b6ee-1c6958cf3686_87323017-7128-4839-9d2a-c99e2137d707.html,Chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat Boehmite (Al(OH)O),1318-23-6,Based on read-across:Oral LD50 (rat) > 2000 mg/kg bwInhalation LC50 (rat) > 2.3 mg/L ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a060b186-0798-4169-bfb3-8be779a72fe5/documents/IUC5-b7db04a6-3f2b-4b4b-88be-9bc85b9d9dad_87323017-7128-4839-9d2a-c99e2137d707.html,,,,,, "Potassium bis[oxalato(2-)-k2O1,O2]borate(1-)",83145-78-2,"LiBOB was tested for toxic effects in male and female Sprague-Dawley rats after consecutive 28-day oral administration (OECD 407) with a prolonged observation period of 14 days. Several treatment- related effects were observed. The derived NOAEL was 40 mg/kg bw/day. In addition, treatment-related effects were observed in a OECD 422 study in Wistar rats with a NOAEL of 30 mg/kg bw/day for systemic effects. No reproductive toxicity was observed (NOAEL 100 mg/kg bw/day). Based on analogue approach, the result can be used for read across, classification and risk assessment of KBOB. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d787005-0bd9-451e-84fa-4f403ea9398c/documents/0a09b427-b91a-477d-b5f0-0a5ba46371ef_8779881d-3584-4382-8485-c2880e3fa2d8.html,,,,,, "Potassium bis[oxalato(2-)-k2O1,O2]borate(1-)",83145-78-2,The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System − Unclassified). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d787005-0bd9-451e-84fa-4f403ea9398c/documents/588f3a1f-2dad-4faf-afc1-9179b6dc7c6a_8779881d-3584-4382-8485-c2880e3fa2d8.html,,,,,, sodium bis(acetyloxy)boranuidyl acetate,56553-60-7,Oral: NOAEL = 300 mg/kg bw/d (OECD 407)Oral: NOAEL = 343 mg/kg bw/d (recalculated from Boron uptake; chronic study) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08a3dd8d-7b28-44a3-af6c-6bc9cdd4c47f/documents/IUC5-a465a155-cdc3-4a56-ac7f-e43fbf1a3b79_11ed4a40-4bc6-445b-afdd-58dc9a16ab7f.html,,,,,, sodium bis(acetyloxy)boranuidyl acetate,56553-60-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08a3dd8d-7b28-44a3-af6c-6bc9cdd4c47f/documents/IUC5-a465a155-cdc3-4a56-ac7f-e43fbf1a3b79_11ed4a40-4bc6-445b-afdd-58dc9a16ab7f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat sodium bis(acetyloxy)boranuidyl acetate,56553-60-7,Oral: 300 mg/kg bw < LD50 < 2000 mg/kg bw (OECD 423) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08a3dd8d-7b28-44a3-af6c-6bc9cdd4c47f/documents/IUC5-e91433fe-9572-4b4c-bf2c-b1fb81688704_11ed4a40-4bc6-445b-afdd-58dc9a16ab7f.html,,,,,, sodium bis(acetyloxy)boranuidyl acetate,56553-60-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08a3dd8d-7b28-44a3-af6c-6bc9cdd4c47f/documents/IUC5-e91433fe-9572-4b4c-bf2c-b1fb81688704_11ed4a40-4bc6-445b-afdd-58dc9a16ab7f.html,,oral,LD50,300 mg/kg bw,adverse effect observed, sodium bis(acetyloxy)boranuidyl acetate,56553-60-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08a3dd8d-7b28-44a3-af6c-6bc9cdd4c47f/documents/IUC5-e91433fe-9572-4b4c-bf2c-b1fb81688704_11ed4a40-4bc6-445b-afdd-58dc9a16ab7f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Boric acid (H3BO3), solid soln. with strontium oxide, europium-doped",102110-29-2, Acute toxicity (oral): LD50 (female) > 5000 mg/kg bw (OECD 423/GLP) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c780bea8-285d-4b74-8c70-23fce2b80389/documents/fc2d1d9a-9375-4c4e-8f55-a2469207d022_37f617eb-0fa4-4dc8-85d1-187808437836.html,,,,,, "Boric acid (H3BO3), solid soln. with strontium oxide, europium-doped",102110-29-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c780bea8-285d-4b74-8c70-23fce2b80389/documents/fc2d1d9a-9375-4c4e-8f55-a2469207d022_37f617eb-0fa4-4dc8-85d1-187808437836.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Boric acid, aluminum salt",11121-16-7,"Read-across from supporting studies with Aluminum oxide as surrogate (Al2O3 is the main part of Aluminum borate) leads to conclusions as follows:It is recommended that aluminium oxide is not to be classified for acute oral, dermal and inhalation toxicity.Oral LD50 (rat) > 2000 mg/kg bwInhalation LC50 (rat) > 2.3 mg/L ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61123ce0-11a2-4731-a065-fc1b1309b870/documents/IUC5-1356e458-8029-4bea-8fa6-c77b084bc699_f571118d-fce1-4e42-872a-bf2d05d2a6fb.html,,,,,, Boron,7440-42-8," No adverse effects observed in a 28-day oral limit dose study (1000 mg/kg/day). No NOAEL derived. A subchronic toxicity study (90 -day) is waived, based on REACH Annex IX, 8.6.2, column 2. For details see ""Additional information"" and the respective endpoints study records. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1bbb93bb-81cc-461b-b51f-a02bccab5944/documents/IUC5-60b9b363-ee92-4511-a608-d1257604c490_205025c8-abce-49d3-922a-27019ddcade5.html,,,,,, Boron,7440-42-8, Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 423 (2001); GLP compliant) Acute inhalation toxicity: LC50 (4 hours) > 5.08 mg/L air (analytical) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bbb93bb-81cc-461b-b51f-a02bccab5944/documents/IUC5-4a49dd40-054c-489d-b102-ce1c264abdac_205025c8-abce-49d3-922a-27019ddcade5.html,,,,,, Boron carbide,12069-32-8,According to Annex I of Regulation (EC) 1272/2008 the test item Boron Carbide B4C is unclassified. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f9d0b01-35a5-43d7-92d1-77c1e93bbef6/documents/08a60738-bcb1-421b-8e18-57c90c7ea7f7_f5ab44c7-42f8-4681-adcb-a7c9472dfb2c.html,,,,,, Boron carbide,12069-32-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f9d0b01-35a5-43d7-92d1-77c1e93bbef6/documents/08a60738-bcb1-421b-8e18-57c90c7ea7f7_f5ab44c7-42f8-4681-adcb-a7c9472dfb2c.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Boron carbide,12069-32-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f9d0b01-35a5-43d7-92d1-77c1e93bbef6/documents/08a60738-bcb1-421b-8e18-57c90c7ea7f7_f5ab44c7-42f8-4681-adcb-a7c9472dfb2c.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Boron orthophosphate,13308-51-5,"RDT (OECD 408, oral), mouse: NOAEL = 934/967 (m/f) mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/916af7d7-c955-4186-a121-e28f3b69ee8e/documents/IUC5-1a834a35-b19d-4bc6-9bbe-95d106ff3ea4_92ed9bca-083b-419b-81cd-540610b95d4e.html,,,,,, Boron orthophosphate,13308-51-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/916af7d7-c955-4186-a121-e28f3b69ee8e/documents/IUC5-1a834a35-b19d-4bc6-9bbe-95d106ff3ea4_92ed9bca-083b-419b-81cd-540610b95d4e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,934 mg/kg bw/day,,mouse Boron orthophosphate,13308-51-5,"Oral (according to OECD 420), rat: > 300 - < 2000 mg/kg bwInhalation (according to OECD 436), rat: > 5.31 mg/L (limit test) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/916af7d7-c955-4186-a121-e28f3b69ee8e/documents/IUC5-bc1e897f-7e4d-400b-9b9a-9a125744d160_92ed9bca-083b-419b-81cd-540610b95d4e.html,,,,,, Boron orthophosphate,13308-51-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/916af7d7-c955-4186-a121-e28f3b69ee8e/documents/IUC5-bc1e897f-7e4d-400b-9b9a-9a125744d160_92ed9bca-083b-419b-81cd-540610b95d4e.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Boron orthophosphate,13308-51-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/916af7d7-c955-4186-a121-e28f3b69ee8e/documents/IUC5-bc1e897f-7e4d-400b-9b9a-9a125744d160_92ed9bca-083b-419b-81cd-540610b95d4e.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Boron trifluoride,7637-07-2,All the studies pointed out that BF3 (gas) or BF3 dihydrate cause signs of respiratory distress and two well conducted studies showed that BF3 dihydrate is responsible for kidney toxicity (necrosis of proximal tubular epithelium). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f70d885-ab69-46ab-9a4d-926f6bf1610e/documents/IUC5-7bfcee98-1b12-41f4-920f-5591676f68bb_06ee165d-b50d-46d2-9dde-15583afe8022.html,,,,,, Boron trifluoride,7637-07-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f70d885-ab69-46ab-9a4d-926f6bf1610e/documents/IUC5-7bfcee98-1b12-41f4-920f-5591676f68bb_06ee165d-b50d-46d2-9dde-15583afe8022.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,6 mg/m3,,rat Boron trifluoride,7637-07-2,"The LC50/4hours is 1210 mg/m3 in rats (Rusch, 1986). Animals mainly exhibited typical clinical signs of respiratory distress.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f70d885-ab69-46ab-9a4d-926f6bf1610e/documents/IUC5-ffb91901-0206-470c-a343-3a10f4cea32e_06ee165d-b50d-46d2-9dde-15583afe8022.html,,,,,, Boron trifluoride,7637-07-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f70d885-ab69-46ab-9a4d-926f6bf1610e/documents/IUC5-ffb91901-0206-470c-a343-3a10f4cea32e_06ee165d-b50d-46d2-9dde-15583afe8022.html,,oral,LD50,326 mg/kg bw,adverse effect observed, Boron trifluoride,7637-07-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f70d885-ab69-46ab-9a4d-926f6bf1610e/documents/IUC5-ffb91901-0206-470c-a343-3a10f4cea32e_06ee165d-b50d-46d2-9dde-15583afe8022.html,,inhalation,LC50,"1,210 mg/m3",adverse effect observed, acetonitrile; trifluoroborane,420-16-6,"All the inhalation studies conducted with BF3 (gas) or BF3 dihydrate caused signs of respiratory distress. This effect was already seen in the acute toxicity tests. Furthermore, necrosis of the proximal tubuli was observed in some animals. This effect correlates with the increasing amount of fluoride in urine. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89bbdfcc-45d8-4f6e-b689-09387fcc442c/documents/IUC5-8bb0d29a-8b54-469e-8b32-8acfb8ea2d8c_43a4c04a-92e5-4f0e-8d70-793aeed8c974.html,,,,,, acetonitrile; trifluoroborane,420-16-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89bbdfcc-45d8-4f6e-b689-09387fcc442c/documents/IUC5-8bb0d29a-8b54-469e-8b32-8acfb8ea2d8c_43a4c04a-92e5-4f0e-8d70-793aeed8c974.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,6 mg/m3,,rat acetonitrile; trifluoroborane,420-16-6,"The LD50 (oral) of acetonitrile in mice was 617 mg/kg bw (BP Chemicals, 1998). The LC50 (4 h) is 1210 mg/m3 in rats with boron trifluoride dihydrate (Rusch et al., 1986). Animals mainly exhibited typical clinical signs of respiratory distress. All respiratory effects were reversible. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89bbdfcc-45d8-4f6e-b689-09387fcc442c/documents/IUC5-bb35e838-1c27-4163-b29f-c71fc1c070f4_43a4c04a-92e5-4f0e-8d70-793aeed8c974.html,,,,,, acetonitrile; trifluoroborane,420-16-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89bbdfcc-45d8-4f6e-b689-09387fcc442c/documents/IUC5-bb35e838-1c27-4163-b29f-c71fc1c070f4_43a4c04a-92e5-4f0e-8d70-793aeed8c974.html,,oral,LD50,617 mg/kg bw,adverse effect observed, acetonitrile; trifluoroborane,420-16-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89bbdfcc-45d8-4f6e-b689-09387fcc442c/documents/IUC5-bb35e838-1c27-4163-b29f-c71fc1c070f4_43a4c04a-92e5-4f0e-8d70-793aeed8c974.html,,inhalation,LC50,"1,210 mg/m3",adverse effect observed, "Boron, (benzenemethanamine)trifluoro-, (T-4)-, reaction products with Bu glycidyl ether",68478-46-6,"The toxicity of the test substance was first analyzed in a 14 day Dose Range Finding Study based on OECD 422 guideline by oral administration to rats. The selected dose groups were 0, 15, 50, 150 mg/kg bw/d, however, because of the low toxicity of the substance the dose levels were increased to 300 mg/kg bw/d (intermediate dose) and 450 mg/kg bw/d (high dose).  The clinical symptoms observed in the study were post dosing salivation from 50 mg/kg bw/d group onwards and piloerection and haemorrhagic canthi from 300 mg/kg bw/d onwards in males. In the higher dose groups also breathing sounds and piloerection could be observed (LPT, 2019).  In the subsequently performed OCED 422 study with female Sprague-Dawley Crl.:CD (SD) strain rats, for up day 15 until one day before sacrifice, the dose levels were 0, 30, 300/400 mg/kg bw/d (Provivo 2022). The administration resulted in a reduced body weight in females. During the lactation period the body weight of the high dosed animals was 3.5% (lactation day 1), 9.9% (lactation day 4), (7.0% lactation day 8) and 6.7% (lactation day 13) below the control value, statistically significant on lactation day 4 (p ≤ 0.01). Histopathological changes have been observed for kidney and the stomach in the intermediat and high dose. The kidney effects are indicative for the early onset of chronic progressive nephropathy (CPN), which is a spontaneous background lesion in rodents and therefore the kidney effects are not tretament related. The inflammatory effects in the somach are caused by the corrosive properties of the test compound and are considered to be local effects.Piloerection was noted for one dam of the high dose group (300/400 mg /kg b.w./day) during nearly the whole lactation period (between test days 56 to 69), whereas no changes in behaviour, the external appearance and the appearance of the faeces were noted for the male animals. A slightly reduced body weight was noted for the female animals of the high dose group (300/400 mg/kg b.w./day) at the end of the gestation period and during the whole lactation period.The No Observed Adverse Effect Level (NOAEL) for systemic toxicity was therefore considered to be 100 mg/kg/d. The local NOEAL was considered to be 30 mg/kg bw/d.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/619ac73a-3e89-47a4-aab0-c8221495ca93/documents/5082d748-36c2-4476-bffb-72dba2356ff0_1c1ac71a-d371-47bc-a6c1-361eeb187eca.html,,,,,, "Boron, (benzenemethanamine)trifluoro-, (T-4)-, reaction products with Bu glycidyl ether",68478-46-6," The acute median lethal oral dose (LD50) and its 95% confidence limits for Boron, (benzenemethanamine)trifluoro-,(t-4)-, reaction products with bu glycidyl ether to rats were determined to be 750 (550 to 1018) mg/kg bodyweight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/619ac73a-3e89-47a4-aab0-c8221495ca93/documents/56c1ad1e-6a14-4ec3-a7b0-c4eab2fdeeef_1c1ac71a-d371-47bc-a6c1-361eeb187eca.html,,,,,, "Boron, (benzenemethanamine)trifluoro-, (T-4)-, reaction products with Bu glycidyl ether",68478-46-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/619ac73a-3e89-47a4-aab0-c8221495ca93/documents/56c1ad1e-6a14-4ec3-a7b0-c4eab2fdeeef_1c1ac71a-d371-47bc-a6c1-361eeb187eca.html,,oral,LD50,750 mg/kg bw,adverse effect observed, "Boronic acid, (4-ethylphenyl)-",63139-21-9," Based on the results of a repeated dose oral toxicity study according to OECD guideline 407, 100 mg/kg body weight/day of the test item were established as the no-observed-effect-level (NOEL) and 300 mg/kg body weight/day of the test item as the no-observed-adverse-effect-level (NOAEL). Treatment with 400 mg/kg/day for two days was not considered to be tolerated by the rats because of the clinical signs and the premature sacrifice (in extremis) of one male (reference 7.5.1-1). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc5bec70-5e46-45c1-9715-3133baa63e29/documents/596e4110-ce64-4bbb-87c7-073057424063_0add9834-7235-4706-af2f-5ef76cc58b12.html,,,,,, "Boronic acid, (4-ethylphenyl)-",63139-21-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc5bec70-5e46-45c1-9715-3133baa63e29/documents/596e4110-ce64-4bbb-87c7-073057424063_0add9834-7235-4706-af2f-5ef76cc58b12.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Boronic acid, (4-ethylphenyl)-",63139-21-9," Based on the results of an acute oral toxicity study according to OECD guideline 423, the LD50 value of the test item is expected between 300 - 2000 mg/kg bw. Based in GHS criteria, the test item is classified for acute oral toxicity, category 4. Based on the result of a acute dermal toxicity study according to OECD guideline, the test item can be considered to have no acute toxic potential to skin. The LD50 value was higher than 2000 mg/kg bw after dermal application to rats (reference 7.2.1-1 and 7.2.3-1). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc5bec70-5e46-45c1-9715-3133baa63e29/documents/6f808c68-ac8b-4077-9542-070453171bf8_0add9834-7235-4706-af2f-5ef76cc58b12.html,,,,,, "Boronic acid, (4-ethylphenyl)-",63139-21-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc5bec70-5e46-45c1-9715-3133baa63e29/documents/6f808c68-ac8b-4077-9542-070453171bf8_0add9834-7235-4706-af2f-5ef76cc58b12.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, "Boronic acid, (4-ethylphenyl)-",63139-21-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc5bec70-5e46-45c1-9715-3133baa63e29/documents/6f808c68-ac8b-4077-9542-070453171bf8_0add9834-7235-4706-af2f-5ef76cc58b12.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Boronic acid, [6-(benzoylmethylamino)-5-methyl-3-pyridinyl]-",446299-81-6," Acute oral toxicity: Key study. Test method according to OECD 420, GLP study. The LD50 of the test item is higher than 2000 mg/ kg body weight by oral route in the rat. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcb2bb60-4ef7-42bf-86eb-9237e53ed740/documents/7982e1c5-c77a-4b12-aee5-b7a2342b6f76_7561ce00-7e5c-49c0-9bc9-2f86bbcdd6aa.html,,,,,, "Boronic acid, [6-(benzoylmethylamino)-5-methyl-3-pyridinyl]-",446299-81-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcb2bb60-4ef7-42bf-86eb-9237e53ed740/documents/7982e1c5-c77a-4b12-aee5-b7a2342b6f76_7561ce00-7e5c-49c0-9bc9-2f86bbcdd6aa.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, (2-fluoro-3-methoxyphenyl)boronic acid,352303-67-4, The results from the acute inhalation and acute dermal toxicity studies indicated that there was no indication of toxicity. The results from the acute oral toxicity study indicated that there was a positive indication of toxicity. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/371e8b9d-619f-4fb5-844c-dda2932c8868/documents/eab9de38-44df-45c7-9530-1bc3746c4abe_78bb00c1-57bb-4cce-bf31-df53f1ca861e.html,,,,,, (2-fluoro-3-methoxyphenyl)boronic acid,352303-67-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/371e8b9d-619f-4fb5-844c-dda2932c8868/documents/eab9de38-44df-45c7-9530-1bc3746c4abe_78bb00c1-57bb-4cce-bf31-df53f1ca861e.html,,oral,LD50,500 mg/kg bw,adverse effect observed, (2-fluoro-3-methoxyphenyl)boronic acid,352303-67-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/371e8b9d-619f-4fb5-844c-dda2932c8868/documents/eab9de38-44df-45c7-9530-1bc3746c4abe_78bb00c1-57bb-4cce-bf31-df53f1ca861e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, (2-fluoro-3-methoxyphenyl)boronic acid,352303-67-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/371e8b9d-619f-4fb5-844c-dda2932c8868/documents/eab9de38-44df-45c7-9530-1bc3746c4abe_78bb00c1-57bb-4cce-bf31-df53f1ca861e.html,,inhalation,LC50,"5,070 mg/m3",no adverse effect observed, "Boswellia papyrifera, ext.",89957-99-3," Acute toxicity, oral in rats: LD50 > 2000 mg/kg bw (OECD 423, GLP, K, Rel. 1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c21d1363-c7b8-45d5-84f8-48ab4a0a888c/documents/3ca89e77-6c66-4bea-a3f6-327cee549098_d4a8b9f0-14ed-4e53-b9b3-1185935c54a9.html,,,,,, "Boswellia papyrifera, ext.",89957-99-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c21d1363-c7b8-45d5-84f8-48ab4a0a888c/documents/3ca89e77-6c66-4bea-a3f6-327cee549098_d4a8b9f0-14ed-4e53-b9b3-1185935c54a9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Bromacil,314-40-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a3b5fff-536b-4cc3-a24a-952f0751f3ff/documents/6d06c432-e316-49a9-8158-d7dc7907e05d_5c3663c7-5b34-4188-a52a-f773710f7297.html,,oral,LD50,550 mg/kg bw,adverse effect observed, Bromo(hexahydro-2H-azepin-2-onato-N)magnesium,17091-31-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): satisfying ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbe821e8-0bc6-4eab-8a92-63a5282c6f87/documents/8022f73f-d2ee-4719-8459-4d79851a695f_5dd1e395-8e70-4aac-87b0-229922b7662a.html,,,,,, Bromo(hexahydro-2H-azepin-2-onato-N)magnesium,17091-31-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbe821e8-0bc6-4eab-8a92-63a5282c6f87/documents/8022f73f-d2ee-4719-8459-4d79851a695f_5dd1e395-8e70-4aac-87b0-229922b7662a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Bromo(hexahydro-2H-azepin-2-onato-N)magnesium,17091-31-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): satisfying Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Acceptable. The LC50 is estimated from the lowest LC50 of epsilon-Caprolactam resulting in an ATE =1.5. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): satisfying ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbe821e8-0bc6-4eab-8a92-63a5282c6f87/documents/6daeebf9-43c1-4ef8-a181-887c81e2defb_5dd1e395-8e70-4aac-87b0-229922b7662a.html,,,,,, Bromo(hexahydro-2H-azepin-2-onato-N)magnesium,17091-31-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbe821e8-0bc6-4eab-8a92-63a5282c6f87/documents/6daeebf9-43c1-4ef8-a181-887c81e2defb_5dd1e395-8e70-4aac-87b0-229922b7662a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Bromo(hexahydro-2H-azepin-2-onato-N)magnesium,17091-31-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbe821e8-0bc6-4eab-8a92-63a5282c6f87/documents/6daeebf9-43c1-4ef8-a181-887c81e2defb_5dd1e395-8e70-4aac-87b0-229922b7662a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Bromo(hexahydro-2H-azepin-2-onato-N)magnesium,17091-31-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbe821e8-0bc6-4eab-8a92-63a5282c6f87/documents/6daeebf9-43c1-4ef8-a181-887c81e2defb_5dd1e395-8e70-4aac-87b0-229922b7662a.html,,inhalation,LC50,"1,500 mg/m3",, Bromoacetic acid,79-08-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A subacute and a subchronic toxicity study are available showing consistent results. Toxicity is slight and can mainly be related to reductions in water and food consumption as well as local effects. No clear systemic toxicity was observed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1a94bb9-33fa-4881-80a5-03550b6a9b02/documents/IUC5-23539a0a-001b-461e-8b79-5f4870c9d7e3_9efee048-5818-42be-89d1-b6c3d05a9b71.html,,,,,, Bromoacetic acid,79-08-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1a94bb9-33fa-4881-80a5-03550b6a9b02/documents/IUC5-23539a0a-001b-461e-8b79-5f4870c9d7e3_9efee048-5818-42be-89d1-b6c3d05a9b71.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10.3 mg/kg bw/day,,rat Bromoacetic acid,79-08-3,"A literature study on acute oral toxicity in male rats is available that resulted in an LD50 valu of 177 mg/kg. Due to the corrosive properties of the substance to skin and mucous membranes dermal studies were perfomed as they are not scientifically justified also from an animal protection poitn of view. The substance is classified according to Regulation EC 1272/2008 (CLP) as acute toxic category 3 by the oral, dermal and inhalation route. This is corroborated by some limited data base data on inhalation and dermal toxicity that are, however of limited reliability. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1a94bb9-33fa-4881-80a5-03550b6a9b02/documents/IUC5-55efc9e3-6278-4831-ba75-cb8bded88261_9efee048-5818-42be-89d1-b6c3d05a9b71.html,,,,,, Bromoacetic acid,79-08-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1a94bb9-33fa-4881-80a5-03550b6a9b02/documents/IUC5-55efc9e3-6278-4831-ba75-cb8bded88261_9efee048-5818-42be-89d1-b6c3d05a9b71.html,,oral,LD50,177 mg/kg bw,adverse effect observed, Bromochloromethane,74-97-5,"The following studies are available for the acute toxicity endpoint:Acute Toxicity Oral.001: LD50 (rat)=5,000 mg/kg bwAcute Toxicity Inhalation.001: LC50 (rat)>38.6 mg/l/4 hourAcute Toxicity Dermal.001: LD50 (rat)>20,000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d31011d9-266c-4647-be1e-7f935519ad00/documents/IUC5-451ea69e-d50f-44dc-baae-d086dc30fb62_f8f2ee50-42c9-4090-8e47-ae28dfc0ceb0.html,,,,,, Bromochloromethane,74-97-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d31011d9-266c-4647-be1e-7f935519ad00/documents/IUC5-451ea69e-d50f-44dc-baae-d086dc30fb62_f8f2ee50-42c9-4090-8e47-ae28dfc0ceb0.html,,oral,LD50,"5,000 mg/kg bw",, Bromochloromethane,74-97-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d31011d9-266c-4647-be1e-7f935519ad00/documents/IUC5-451ea69e-d50f-44dc-baae-d086dc30fb62_f8f2ee50-42c9-4090-8e47-ae28dfc0ceb0.html,,dermal,LD50,"20,000 mg/kg bw",, Bromochloromethane,74-97-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d31011d9-266c-4647-be1e-7f935519ad00/documents/IUC5-451ea69e-d50f-44dc-baae-d086dc30fb62_f8f2ee50-42c9-4090-8e47-ae28dfc0ceb0.html,,inhalation,LC50,38.6 mg/m3,, Bromoform,75-25-2, Toxicity of Bromoform following repeated oral dosing. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b03e4140-5beb-4ee5-8668-35b73ff27ea5/documents/d7b2961c-589e-4019-8772-0f58f12707d0_33014658-0971-4cc8-89af-34184bab700e.html,,,,,, Bromoform,75-25-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b03e4140-5beb-4ee5-8668-35b73ff27ea5/documents/d7b2961c-589e-4019-8772-0f58f12707d0_33014658-0971-4cc8-89af-34184bab700e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,12 mg/kg bw/day,,rat Bromoform,75-25-2, Acute toxicity of the test substance. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b03e4140-5beb-4ee5-8668-35b73ff27ea5/documents/f75a2089-9aa2-45e0-9b16-3bc3c36f89b9_33014658-0971-4cc8-89af-34184bab700e.html,,,,,, Bromoform,75-25-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b03e4140-5beb-4ee5-8668-35b73ff27ea5/documents/f75a2089-9aa2-45e0-9b16-3bc3c36f89b9_33014658-0971-4cc8-89af-34184bab700e.html,,oral,LD50,"1,147 mg/kg bw",adverse effect observed, "Trisodium, bis [2-((E)-(4-hydroxy-2-oxido-3-((E)-(5-sulfonatonaphthalen-1-yl)diazenyl)phenyl)diazenyl)benzoate] chromate(3-)",94933-05-8," NOAEL (28 days, rat, dermal) ≥ 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d24738e-e7b4-4df2-a07d-fe241f09581a/documents/db1ffe87-f58e-4c13-8a1e-ba1dcebdf7f1_fc995ec0-9682-4f41-9f44-e2687bcc0f0d.html,,,,,, "Trisodium, bis [2-((E)-(4-hydroxy-2-oxido-3-((E)-(5-sulfonatonaphthalen-1-yl)diazenyl)phenyl)diazenyl)benzoate] chromate(3-)",94933-05-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d24738e-e7b4-4df2-a07d-fe241f09581a/documents/db1ffe87-f58e-4c13-8a1e-ba1dcebdf7f1_fc995ec0-9682-4f41-9f44-e2687bcc0f0d.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Trisodium, bis [2-((E)-(4-hydroxy-2-oxido-3-((E)-(5-sulfonatonaphthalen-1-yl)diazenyl)phenyl)diazenyl)benzoate] chromate(3-)",94933-05-8," LD50 (oral, rat) > 5000 mg/kg bw LD50 (dermal, rat) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d24738e-e7b4-4df2-a07d-fe241f09581a/documents/1f6daa72-84e2-40cc-8f8e-db3ee3d78d61_fc995ec0-9682-4f41-9f44-e2687bcc0f0d.html,,,,,, "Trisodium, bis [2-((E)-(4-hydroxy-2-oxido-3-((E)-(5-sulfonatonaphthalen-1-yl)diazenyl)phenyl)diazenyl)benzoate] chromate(3-)",94933-05-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d24738e-e7b4-4df2-a07d-fe241f09581a/documents/1f6daa72-84e2-40cc-8f8e-db3ee3d78d61_fc995ec0-9682-4f41-9f44-e2687bcc0f0d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Trisodium, bis [2-((E)-(4-hydroxy-2-oxido-3-((E)-(5-sulfonatonaphthalen-1-yl)diazenyl)phenyl)diazenyl)benzoate] chromate(3-)",94933-05-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d24738e-e7b4-4df2-a07d-fe241f09581a/documents/1f6daa72-84e2-40cc-8f8e-db3ee3d78d61_fc995ec0-9682-4f41-9f44-e2687bcc0f0d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Bulnesia sarmienti, ext., sapond.",90244-88-5,Acute oral toxicity: LD50 >5000 mg/kg bw (similar to OECD 401) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/730dcf8b-25d6-42ac-81cf-0372f8f16cab/documents/7bf2ca93-c2fa-457d-bfb9-789c5e51dd0a_17bf7cb7-413b-4660-9072-7b4651e428af.html,,,,,, "Bulnesia sarmienti, ext., sapond.",90244-88-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/730dcf8b-25d6-42ac-81cf-0372f8f16cab/documents/7bf2ca93-c2fa-457d-bfb9-789c5e51dd0a_17bf7cb7-413b-4660-9072-7b4651e428af.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "But-2-yne-1,4-diol",110-65-6,"subacute NOAEL (rat oral) = 1 mg/kg bw/day subacute NOAEC (rat inhalation, systemic) = 25 mg/m3subacute NOAEC (rat inhalation, local) = 0.5 mg/m3 (irritation of nose, larynx, trachea) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/912481f6-6caa-4994-8ca4-c4bdb2e1ad51/documents/IUC5-dc969546-fde5-45b4-b60d-36fb08172455_a139b3fc-42f6-42ea-b089-0691755eb52f.html,,,,,, "But-2-yne-1,4-diol",110-65-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/912481f6-6caa-4994-8ca4-c4bdb2e1ad51/documents/IUC5-dc969546-fde5-45b4-b60d-36fb08172455_a139b3fc-42f6-42ea-b089-0691755eb52f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,1 mg/kg bw/day,,rat "But-2-yne-1,4-diol",110-65-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/912481f6-6caa-4994-8ca4-c4bdb2e1ad51/documents/IUC5-dc969546-fde5-45b4-b60d-36fb08172455_a139b3fc-42f6-42ea-b089-0691755eb52f.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,25 mg/m3,,rat "But-2-yne-1,4-diol",110-65-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/912481f6-6caa-4994-8ca4-c4bdb2e1ad51/documents/IUC5-dc969546-fde5-45b4-b60d-36fb08172455_a139b3fc-42f6-42ea-b089-0691755eb52f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.5 mg/m3,adverse effect observed,rat "But-2-yne-1,4-diol",110-65-6,Oral LD50 = 132 mg/kg bwDermal LD50 = 659 mg/kg bwInhalation LC50 = 690 mg/m3 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/912481f6-6caa-4994-8ca4-c4bdb2e1ad51/documents/IUC5-97b8d6a3-45d2-4ffd-80ea-a185b66c501b_a139b3fc-42f6-42ea-b089-0691755eb52f.html,,,,,, "But-2-yne-1,4-diol",110-65-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/912481f6-6caa-4994-8ca4-c4bdb2e1ad51/documents/IUC5-97b8d6a3-45d2-4ffd-80ea-a185b66c501b_a139b3fc-42f6-42ea-b089-0691755eb52f.html,,oral,LD50,132 mg/kg bw,, "But-2-yne-1,4-diol",110-65-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/912481f6-6caa-4994-8ca4-c4bdb2e1ad51/documents/IUC5-97b8d6a3-45d2-4ffd-80ea-a185b66c501b_a139b3fc-42f6-42ea-b089-0691755eb52f.html,,dermal,LD50,659 mg/kg bw,, "But-2-yne-1,4-diol",110-65-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/912481f6-6caa-4994-8ca4-c4bdb2e1ad51/documents/IUC5-97b8d6a3-45d2-4ffd-80ea-a185b66c501b_a139b3fc-42f6-42ea-b089-0691755eb52f.html,,inhalation,LC50,690 mg/m3,, But-3-en-3-olide,674-82-8,"Oral:- male rats, LD50: 613 mg/kg bw (limited data only)- rats, LD50: 540 mg/kg bw (limited data only)Inhalation:- male/female rats, LC50: 0.94 mg/L- male rats, LC50: 0.82 mg/L- female rats, LC50: 1.01 mg/LDermal:- male rabbits, LD50: 3100 mg/kg bw (limited data only)- male rabbits, LD50: 6730 mg/kg bw (limited data only) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84b4fa5e-be05-488d-94b7-99f924913f52/documents/IUC5-4bc28277-5bd1-4e75-8af8-47f90d1f6c18_fcb28eaf-dd88-4c11-99af-9c12e19bbd66.html,,,,,, But-3-en-3-olide,674-82-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84b4fa5e-be05-488d-94b7-99f924913f52/documents/IUC5-4bc28277-5bd1-4e75-8af8-47f90d1f6c18_fcb28eaf-dd88-4c11-99af-9c12e19bbd66.html,,oral,LD50,540 mg/kg bw,, But-3-en-3-olide,674-82-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84b4fa5e-be05-488d-94b7-99f924913f52/documents/IUC5-4bc28277-5bd1-4e75-8af8-47f90d1f6c18_fcb28eaf-dd88-4c11-99af-9c12e19bbd66.html,,inhalation,LC50,820 mg/m3,, But-3-yn-2-ol,2028-63-9,An acute oral LD50 for rats was established to be 45 mg/kg bw.The LD50 for acute inhalation toxicity in rats was determined to be > 0.53 mg/L and < 2.09 mg/L. For acute dermal toxicity the LD50 range was established to be > 69 to < 172 mg/kg bw in rabbits. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/855259c7-e311-474b-8655-db1896d90fef/documents/IUC5-3fbbdd5d-79d9-4f81-88b8-29bc1bf65f60_087559f2-e750-4050-a951-5434e1be5a30.html,,,,,, But-3-yn-2-ol,2028-63-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/855259c7-e311-474b-8655-db1896d90fef/documents/IUC5-3fbbdd5d-79d9-4f81-88b8-29bc1bf65f60_087559f2-e750-4050-a951-5434e1be5a30.html,,oral,LD50,45 mg/kg bw,adverse effect observed, But-3-yn-2-ol,2028-63-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/855259c7-e311-474b-8655-db1896d90fef/documents/IUC5-3fbbdd5d-79d9-4f81-88b8-29bc1bf65f60_087559f2-e750-4050-a951-5434e1be5a30.html,,dermal,discriminating dose,69 mg/kg bw,adverse effect observed, But-3-yn-2-ol,2028-63-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/855259c7-e311-474b-8655-db1896d90fef/documents/IUC5-3fbbdd5d-79d9-4f81-88b8-29bc1bf65f60_087559f2-e750-4050-a951-5434e1be5a30.html,,inhalation,LC50,530 mg/m3,adverse effect observed, "Buta-1,2-diene",590-19-2,"There are no repeat dosing studies carried out on 1,2-butadiene itself but a weight of evidence evaluation of repeat dosing studies with 1,3-butadiene and the mono-butene isomer, 2-methylpropene isomer indicates that 1,2-butadiene has low potential for repeat dose toxicity. The NOAEC of 1000 ppm (2212 mg/m3) is based on the NOAEC for 1,3-butadiene in rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/476d2450-e59c-4bf7-ab54-6a14f7472d98/documents/IUC5-e18f2b72-2b1b-4a35-9347-4838cd33584e_f4d926e7-d580-46a3-a182-be4712535bee.html,,,,,, "Buta-1,2-diene",590-19-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/476d2450-e59c-4bf7-ab54-6a14f7472d98/documents/IUC5-e18f2b72-2b1b-4a35-9347-4838cd33584e_f4d926e7-d580-46a3-a182-be4712535bee.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"2,212 mg/m3",, "Buta-1,2-diene",590-19-2,"1,2-Butadiene is a flammable gas at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. The acute inhalation LC50 of 1,2-butadiene in rats is greater than 8000 ppm (17,701 mg/m3) (the explosive limit). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/476d2450-e59c-4bf7-ab54-6a14f7472d98/documents/IUC5-acf4f380-ae33-4de9-94bd-93a2e6c34e32_f4d926e7-d580-46a3-a182-be4712535bee.html,,,,,, Butamirate,18109-80-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available DL50 is the result of an acute toxicity study with butamirate citrate (the final Active Pharmaceutical Ingredient) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6dfc16f6-cd80-404a-839e-e940cdba48f8/documents/e5a96151-9607-42ac-9c05-1ec3c2e4fe70_90e52537-cbad-405d-81d7-7d6095affe02.html,,,,,, Butamirate,18109-80-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6dfc16f6-cd80-404a-839e-e940cdba48f8/documents/e5a96151-9607-42ac-9c05-1ec3c2e4fe70_90e52537-cbad-405d-81d7-7d6095affe02.html,,oral,LD50,"4,164 mg/kg bw",no adverse effect observed, "Butan-2-one O,O',O''-(vinylsilylidyne)trioxime",2224-33-1,"Oral (OECD 422), rat: NOAEL = 10 mg/kg bw/day (RA from CAS 22984-54-9)   Inhalation (EPA OTS 798.3300), rat, 6 h/day, 26 months: LOAEC (systemic and local) = 15 ppm (54 mg/m³) (RA from CAS 96-29-7) Inhalation (EPA OTS 798.3300), mouse, 6 h/day, 18 months: LOAEC (systemic and local) = 15 ppm (54 mg/m³) (RA from CAS 96-29-7)   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0d91426-fe8f-469c-a26e-abebca4828ce/documents/IUC5-9f6cb6f6-581b-4a46-a32f-1b1d0026a09a_5bbc2be8-36ad-46ec-9456-bc6c5d077552.html,,,,,, "Butan-2-one O,O',O''-(vinylsilylidyne)trioxime",2224-33-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0d91426-fe8f-469c-a26e-abebca4828ce/documents/IUC5-9f6cb6f6-581b-4a46-a32f-1b1d0026a09a_5bbc2be8-36ad-46ec-9456-bc6c5d077552.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "Butan-2-one O,O',O''-(vinylsilylidyne)trioxime",2224-33-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0d91426-fe8f-469c-a26e-abebca4828ce/documents/IUC5-9f6cb6f6-581b-4a46-a32f-1b1d0026a09a_5bbc2be8-36ad-46ec-9456-bc6c5d077552.html,Chronic toxicity – systemic effects,inhalation,LOAEC,15 ,, "Butan-2-one O,O',O''-(vinylsilylidyne)trioxime",2224-33-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0d91426-fe8f-469c-a26e-abebca4828ce/documents/IUC5-9f6cb6f6-581b-4a46-a32f-1b1d0026a09a_5bbc2be8-36ad-46ec-9456-bc6c5d077552.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 ,adverse effect observed, "Butan-2-one O,O',O''-(vinylsilylidyne)trioxime",2224-33-1,"Oral (OECD 425), rat: LD50 >2000 mg/kg bw Dermal: (OCED 402), rat: LD50 >2009 mg/kg bw (limit test) Inhalation: no data ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0d91426-fe8f-469c-a26e-abebca4828ce/documents/IUC5-9fe066e4-2ef0-4212-af4b-57e70c170115_5bbc2be8-36ad-46ec-9456-bc6c5d077552.html,,,,,, "Butan-2-one O,O',O''-(vinylsilylidyne)trioxime",2224-33-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0d91426-fe8f-469c-a26e-abebca4828ce/documents/IUC5-9fe066e4-2ef0-4212-af4b-57e70c170115_5bbc2be8-36ad-46ec-9456-bc6c5d077552.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Butan-2-one O,O',O''-(vinylsilylidyne)trioxime",2224-33-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0d91426-fe8f-469c-a26e-abebca4828ce/documents/IUC5-9fe066e4-2ef0-4212-af4b-57e70c170115_5bbc2be8-36ad-46ec-9456-bc6c5d077552.html,,dermal,LD50,"> 2,009 mg/kg bw",no adverse effect observed, "Butan-2-one O,O',O'',O'''-silanetetrayltetraoxime",34206-40-1,"Key study: Based on the read-across approach from experimental results on analogue butanone oxime, the NOAEL for butan-2-one O,O',O'',O'''-silanetetrayltetraoxime for 13 weeks repeated dose toxicity by oral route in rats was estimated to be 333.54 ppm (26.73 and 32.07 mg/kg bw/day for males and females respectively).Supporting study: Based on the read-across approach from experimental results on analogue butanone oxime, the NOAEL for butan-2-one-O,O',O''-(methylsilanetriyl)oxime for 13 weeks repeated dose toxicity by oral route in mice was estimated to be 720.89 ppm (126.88 mg/kg bw/day) for males and 1441.79 ppm (392.17 mg/kg bw/day) for females.Key study: Based on the read-across approach from experimental results on analogue butanone oxime, the NOEL for butan-2-one-O,O',O''-(methylsilanetriyl)oxime for 28 days repeated dose toxicity by oral route in rats was estimated to be 4.61 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32982b52-1d22-4f14-adc3-d5a31dd8af20/documents/IUC5-b2db5039-2169-461c-afa8-b0fefcbbc52d_ba9ba9f8-8a73-457b-a0e8-a612cbfa3b4f.html,,,,,, "Butan-2-one O,O',O'',O'''-silanetetrayltetraoxime",34206-40-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32982b52-1d22-4f14-adc3-d5a31dd8af20/documents/IUC5-b2db5039-2169-461c-afa8-b0fefcbbc52d_ba9ba9f8-8a73-457b-a0e8-a612cbfa3b4f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,26.73 mg/kg bw/day,,rat "Butan-2-one O,O',O'',O'''-silanetetrayltetraoxime",34206-40-1,"Acute oral toxicity: Key study: Test according to OECD guideline 401. GLP study. LD50 was determined to be 2317.10 mg/kg bw. Acute dermal toxicity: Key study: Test method according to OECD 402. GLP study. LD50 was determined to be > 2000 mg/kg bw.Acute inhalation toxicity: Data waiving (other justification): According to REACH Annex VIII, column 2, the study was not needed to be performed since the choice for the second routh in addition for the oral route was provided for dermal route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32982b52-1d22-4f14-adc3-d5a31dd8af20/documents/IUC5-8519205c-9631-4a2e-a4a4-92e9cb8a963c_ba9ba9f8-8a73-457b-a0e8-a612cbfa3b4f.html,,,,,, "Butan-2-one O,O',O'',O'''-silanetetrayltetraoxime",34206-40-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32982b52-1d22-4f14-adc3-d5a31dd8af20/documents/IUC5-8519205c-9631-4a2e-a4a4-92e9cb8a963c_ba9ba9f8-8a73-457b-a0e8-a612cbfa3b4f.html,,oral,LD50,"2,282.81 mg/kg bw",no adverse effect observed, "Butan-2-one O,O',O'',O'''-silanetetrayltetraoxime",34206-40-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32982b52-1d22-4f14-adc3-d5a31dd8af20/documents/IUC5-8519205c-9631-4a2e-a4a4-92e9cb8a963c_ba9ba9f8-8a73-457b-a0e8-a612cbfa3b4f.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 4-(heptyloxy)-3-methylbutanal,1093653-57-6,"Key study: Dietary repeated dose toxicity test (OECD TG 407): NOAEL is 368 mg/kg bw/day using actual lowest intake values (nominal diet dose 4900 ppm), this value will be used for the risk characterisation being the more complete study for systemic toxicity. Supporting study: Dietary Extended Reproscreen study (OECD TG 421 (9 weeks) and including additional systemic parameters): NOAEL is 302 mg/kg bw using actual lowest intake values (nominal diet dose 4900 ppm) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP compliant OECD TG 407 study ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/959e15ec-4be1-4196-8ddf-3ad6f69f9ce8/documents/IUC5-831f3893-0f48-49d9-8de2-1218d5db0f30_dede6355-076e-45ad-8389-87b5ce8f86f0.html,,,,,, 4-(heptyloxy)-3-methylbutanal,1093653-57-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/959e15ec-4be1-4196-8ddf-3ad6f69f9ce8/documents/IUC5-831f3893-0f48-49d9-8de2-1218d5db0f30_dede6355-076e-45ad-8389-87b5ce8f86f0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,368 mg/kg bw/day,,rat 4-(heptyloxy)-3-methylbutanal,1093653-57-6,Acute oral toxicity: LD50 is > 2000 mg/kg bw in an OECD TG 423 Acute inhalation toxicity: LC50 is > 5.25 mg/l in an OECD TG 436 Acute dermal toxicity: LD50 is > 2000 mg/kg bw in an OECD TG 402 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/959e15ec-4be1-4196-8ddf-3ad6f69f9ce8/documents/IUC5-4e4a3018-8f36-471c-88de-a2d8529e0ae9_dede6355-076e-45ad-8389-87b5ce8f86f0.html,,,,,, 4-(heptyloxy)-3-methylbutanal,1093653-57-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/959e15ec-4be1-4196-8ddf-3ad6f69f9ce8/documents/IUC5-4e4a3018-8f36-471c-88de-a2d8529e0ae9_dede6355-076e-45ad-8389-87b5ce8f86f0.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 4-(heptyloxy)-3-methylbutanal,1093653-57-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/959e15ec-4be1-4196-8ddf-3ad6f69f9ce8/documents/IUC5-4e4a3018-8f36-471c-88de-a2d8529e0ae9_dede6355-076e-45ad-8389-87b5ce8f86f0.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 4-(heptyloxy)-3-methylbutanal,1093653-57-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/959e15ec-4be1-4196-8ddf-3ad6f69f9ce8/documents/IUC5-4e4a3018-8f36-471c-88de-a2d8529e0ae9_dede6355-076e-45ad-8389-87b5ce8f86f0.html,,inhalation,LC50,> 5.25 mg/L,no adverse effect observed, "Butanal, reaction products with aniline",68411-20-1," In a subacute study Butanal, reaction products with aniline was administered by gavage to 5 male and 5 female Wistar (HsdRCCHan) rats per dose group in daily doses of 0, 25, 100 or 400 mg/kg body weight for a period of at least 32 days. The animals were regularly observed and weighed and food and water intakes were determined. In addition, clinical pathology of blood samples was performed. Organs and tissues were subjected to gross and histopathological investigation. Functional observational battery (FOB) and motor and locomotor activity measurements (MA/LMA) were done. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3c0d861-bf0a-4abc-a927-c3f03e24625a/documents/IUC5-66ac5dbb-c2ca-4526-b613-6946ee6ec9ce_aa738109-68f4-4a5c-ab50-5b61b0a3ebc4.html,,,,,, "Butanal, reaction products with aniline",68411-20-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3c0d861-bf0a-4abc-a927-c3f03e24625a/documents/IUC5-66ac5dbb-c2ca-4526-b613-6946ee6ec9ce_aa738109-68f4-4a5c-ab50-5b61b0a3ebc4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat "Butanal, reaction products with aniline",68411-20-1, A valid oral toxicity study and a sufficient documented acute dermal toxicity study from a reliable source are available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3c0d861-bf0a-4abc-a927-c3f03e24625a/documents/IUC5-65c60b74-853e-42cd-8cc9-a92302056732_aa738109-68f4-4a5c-ab50-5b61b0a3ebc4.html,,,,,, "Butanal, reaction products with aniline",68411-20-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3c0d861-bf0a-4abc-a927-c3f03e24625a/documents/IUC5-65c60b74-853e-42cd-8cc9-a92302056732_aa738109-68f4-4a5c-ab50-5b61b0a3ebc4.html,,oral,LD50,"3,830 mg/kg bw",adverse effect observed, "Butanal, reaction products with aniline",68411-20-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3c0d861-bf0a-4abc-a927-c3f03e24625a/documents/IUC5-65c60b74-853e-42cd-8cc9-a92302056732_aa738109-68f4-4a5c-ab50-5b61b0a3ebc4.html,,dermal,discriminating dose,"7,940 mg/kg bw",no adverse effect observed, "Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(4-chloro-2,5-dimethoxyphenyl and 2,4-xylyl) derivs.",90268-24-9," A combined oral repeated dose toxicity study with reproduction/developmental toxicity screening testwith with the close analogue substance PY12 administered by gavage in Wistar rats (10/sex/dose) was performed according to OECD TG 422. The dose levels for this study were0, 50, 200 and 1000 mg/kg/day.Oral dosing of male and fernale Wistar rats (10 per sex and group) with the test item at dose levels of 50, 200 or 1000 mg/kg b.w./day for at least 28 days, revealed no treatment-related findings onparental animals, on fertility, on embryo-foetal development, or on pup development.From the results presented in this report a definitive No Observed Adverse Effect Level(NOAEL) for parental and reproduction/developmental toxicity for the test item of1000 mg/kg/day was established. Sprague Dawley rats (50 per sex per dose) were exposed to 1000, 3000, 9000 ppm test item in diet (corresponding to 62, 186, 555 mg/kg bw/day and 64, 194, 579 mg/kg bw/day in male and female rats, respectively) for 104 weeks. The test item did neither induce toxicity nor tumorigenicity. The NOAEL in this study was 9000 ppm in diet. Subacute inhalation toxicity of the close analogue PY13 was investigated in an 21 days aerosol inhalation study in rats, which were exposed to 0, 52, 151, 401 mg/m³ test item (6 h/d, 5 d/w). A slight but significant (p < 0.01) decrease in the bodyweight of the male rats an the highest concentration at termination of the exposure period was observed when compared with those of the controls and the other treated animals. A slight change was found to occur in the differential leucocyte count of male and female rats at the highest exposure level, where a higher percentage of polymorphonuclear neutrophils and a lower percentage of lymphocytes was observed. This change persisted upon cessation of treatment. The lungs of all rats from the highest concentration group were slightly enlarged and yellowish in colour. The yellowish dis­coloration of the lungs was also noted in rats from the group which was sacrificed after an additional recovery period of 21 days. The lung weights, the lung to bodyweight and lung to brain weight ratios of these animals were significantly increased. The weight increase persisted in rats of this group after anadditional recovery period of 21 days. Upon histopathological examination the lungs of all rats from the highest concentration group showed focal accumulation of slightly basophilic material and of numerous foamy cells in the alveoli. In frozen sections large amount of minute yellow-brownforeign particles (1 - 3 µm) in the lumen of the alveoli, in the cytoplasm of some foamy cells, in the lumen of occasional small bronchi and in the macrophages in the interstitium were observed. There was also slight focal lymphohistiocytic infiltration in the interstitium. Focal pneumoconiosis showing brown-yellow foreign particles (dissolved by the procedure used for tissue embedding) was also observed in the treated rats from the top concentration level after the withdrawal period of 3 weeks. Small accumulation of brown-yellow particles was occasionally found in the intra­pulmonal lymphoid tissue of these animals. In the rats treated with the intermediate concentration level the lungs showed at autopsy slight yellowish discoloration. Histo­pathology revealed brown-yellow, fat soluble particles in the alveoli and in the interstitium of the lungs. In 8 out of 20 rats from this group focal accumulation of foamy cells in several alveoli was observed as well. The yellowish discoloration of the lungs was not observed in rats from the lowest concentration group. Neither accumulation of foamy cells in the alveoli, nor interstitial inflammatory infiltration was seen upon histopathology in these animals. Minute brown­yellow fat soluble foreign particles were however found in frozen sections in the interstitium of the lungs and in occasional alveoli. No other gross or microscopical changes which could be related to the inhalation of the test item were found in the treated animals. It can be inferred from the observations made during the above study that the ""no observable effect level"" for rats is below 52 mg/m³ of air. The effects observed at the lowest test concentration were only due to the deposition of the test material but did not cause adverse effects like inflammation etc. Therefore, the lowest test concentration can be regarded as ""no observable adverse effect level"". ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a377c288-78bb-45c2-82b4-18f57830c70f/documents/fdfdef5d-1829-4dcb-a5a0-3613eab787e4_5f075ac7-cf4d-450a-b4d7-c0b875beaabe.html,,,,,, "Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(4-chloro-2,5-dimethoxyphenyl and 2,4-xylyl) derivs.",90268-24-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a377c288-78bb-45c2-82b4-18f57830c70f/documents/fdfdef5d-1829-4dcb-a5a0-3613eab787e4_5f075ac7-cf4d-450a-b4d7-c0b875beaabe.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(4-chloro-2,5-dimethoxyphenyl and 2,4-xylyl) derivs.",90268-24-9," Male and female Wistar rats were subjected to test acute oral toxicity. The test substance was administered by gavage at the limit dose of 5000 mg/kg bw (corresponding to 3550 mg submission substance/kg bw). No animal died under these conditions, resulting in a LD50 > 5000 mg/kg bw (corresponding to > 3550 mg submission substance/kg bw). The submission substance has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a377c288-78bb-45c2-82b4-18f57830c70f/documents/03e00286-1dab-41e3-90d5-1908ecb7ccaa_5f075ac7-cf4d-450a-b4d7-c0b875beaabe.html,,,,,, "Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(4-chloro-2,5-dimethoxyphenyl and 2,4-xylyl) derivs.",90268-24-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a377c288-78bb-45c2-82b4-18f57830c70f/documents/03e00286-1dab-41e3-90d5-1908ecb7ccaa_5f075ac7-cf4d-450a-b4d7-c0b875beaabe.html,,oral,LD50,"3,550 mg/kg bw",no adverse effect observed, "Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(4-chloro-2,5-dimethoxyphenyl and 2,4-xylyl) derivs.",90268-24-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a377c288-78bb-45c2-82b4-18f57830c70f/documents/03e00286-1dab-41e3-90d5-1908ecb7ccaa_5f075ac7-cf4d-450a-b4d7-c0b875beaabe.html,,dermal,LD50,"1,710 mg/kg bw",no adverse effect observed, "Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(4-chloro-2,5-dimethoxyphenyl and 2,4-xylyl) derivs.",90268-24-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a377c288-78bb-45c2-82b4-18f57830c70f/documents/03e00286-1dab-41e3-90d5-1908ecb7ccaa_5f075ac7-cf4d-450a-b4d7-c0b875beaabe.html,,inhalation,LC50,"4,250 mg/m3",no adverse effect observed, "Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(p-anisyl and Ph) derivs.",90268-23-8," A combined repeated dose toxicity study with reproduction/developmental toxicity screening test with the test item administered by oral gavage in Wistar rats (10/sex/dose) was performed according to OECD TG 422. Oral dosing of male and fernale Wistar rats (10 per sex and group) with the test item at dose levels of 50, 200 or 1000 mg/kg b.w./day for at least 28 days, revealed no treatment-related findings onparental animals, on fertility, on embryo-foetal development, or on pup development. From the results presented a definitive No Observed Adverse Effect Level(NOAEL) for parental and reproduction/developmental toxicity for the test item of 1000 mg/kg/day was established. Sprague Dawley rats (50 per sex per dose) were exposed to 1000, 3000, 9000 ppm test item in diet (corresponding to 62, 186, 555 mg/kg bw/day and 64, 194, 579 mg/kg bw/day in male and female rats, respectively) for 104 weeks. The test item did neither induce toxicity nor tumorigenicity. The NOAEL in this study was 9000 ppm in diet. Subacute toxicity of the test item was investigated in an 21 days aerosol inhalation study in rats, which were exposed to 0, 54, 157, 410 mg/m3 test item (6 h/d, 5 d/w). The bodyweights of the male and female rats of the highest treatment group were slightly decreased during the exposure period when compared with those of the control and other treated groups. In the treated rats from all concentration level groups yellowish or yellow discoloration of the lungs was seen at autopsy. Slight but significant increase of both absolute and relative weights of the lungs was noted in rats from the top concentration group. Histopathology revealed in the lungs of these rats pneumoconiosis showing numerous brown-yellow, birefringent particles about 2 - 4 µm in diameter in the lumen of numerous alveoli, in small bronchi, in numerous histiocytes in the interstitium and in peribronchial lymphatic tissue, associated with focal accumulation of foamy pneumocytes in the alveoli and focal lymphohistiocytic infiltration. After a recovery period of 21 days, to which a further group of rats exposed to the 410 mg/m3concentration of the tested compound was subjected, practically no regression of the pulmonal changes was observed. In treated rats from the 157 mg/m3and 54 mg/m3concentration groups focal accumulation of minute brown-yellow, birefringent particles was observed in the cytoplasm of histiocytic elements in the interstitium, in occasional alveoli, in the lumen of a few small bronchi and very occasionally also in the peribronchial lymphatic tissue, however without obvious accumulation of foamy cells in the alveoli and without inflammatory infiltration. Other minor microscopical findings obtained in some treated and control animals were only incidental in nature and not related to the inhalation of the test item. It can be inferred from the observations made during the above study that the ""no observable effect level"" for rats is below 54 mg/m3air. The effects observed at the mid and low test concentration were only due to the deposition of the test material but did not cause adverse effects like inflammation etc. Therefore, the mid test concentration of 157 mg/m3 can be regarded as ""no observable adverse effect level"". ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43e69946-0213-430d-80a6-bcf310d485ee/documents/864c3544-6686-43ba-aca5-25a0b415797f_1d1b07ad-3cc4-42b9-9460-1577b99a2042.html,,,,,, "Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(p-anisyl and Ph) derivs.",90268-23-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43e69946-0213-430d-80a6-bcf310d485ee/documents/864c3544-6686-43ba-aca5-25a0b415797f_1d1b07ad-3cc4-42b9-9460-1577b99a2042.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(p-anisyl and Ph) derivs.",90268-23-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43e69946-0213-430d-80a6-bcf310d485ee/documents/864c3544-6686-43ba-aca5-25a0b415797f_1d1b07ad-3cc4-42b9-9460-1577b99a2042.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,230 mg/m3,,rat "Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(p-anisyl and Ph) derivs.",90268-23-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43e69946-0213-430d-80a6-bcf310d485ee/documents/864c3544-6686-43ba-aca5-25a0b415797f_1d1b07ad-3cc4-42b9-9460-1577b99a2042.html,Repeated dose toxicity – local effects,inhalation,NOAEC,230 mg/m3,no adverse effect observed,rat "Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(p-anisyl and Ph) derivs.",90268-23-8,"Female rats were subjected to test acute oral toxicity. The test substance was administered by gavage at the highest applicable dose of 2000 mg/kg bw. No animals died during the 14 day observation period. At the end of the observation period there were no changes found in necropsy in all animals. Due to this findings the oral LD50 value is > 2000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43e69946-0213-430d-80a6-bcf310d485ee/documents/a2a19ca3-a18b-43b3-b811-8942cc84f646_1d1b07ad-3cc4-42b9-9460-1577b99a2042.html,,,,,, "Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(p-anisyl and Ph) derivs.",90268-23-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43e69946-0213-430d-80a6-bcf310d485ee/documents/a2a19ca3-a18b-43b3-b811-8942cc84f646_1d1b07ad-3cc4-42b9-9460-1577b99a2042.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Butanamide, 2,2'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[3-oxo-, N,N'-bis(p-anisyl and Ph) derivs.",90268-23-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43e69946-0213-430d-80a6-bcf310d485ee/documents/a2a19ca3-a18b-43b3-b811-8942cc84f646_1d1b07ad-3cc4-42b9-9460-1577b99a2042.html,,inhalation,,> Physical form,, 2-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(2-methoxyphenyl)-3-oxobutanamide,80675-49-6," Oral: In an in vivo repeated dose toxicity study in rats according to OECD guideline 407 (BASF SE, 2010), a NOAEL of > 1000 mg/kg bw/day was determined. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ab91cc5-e362-4860-b3dc-169d2ece0c07/documents/3ddf2406-bac7-463e-9471-de5f147812b3_38e12503-6e5f-4526-9647-802e03fd5a08.html,,,,,, 2-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(2-methoxyphenyl)-3-oxobutanamide,80675-49-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ab91cc5-e362-4860-b3dc-169d2ece0c07/documents/3ddf2406-bac7-463e-9471-de5f147812b3_38e12503-6e5f-4526-9647-802e03fd5a08.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 2-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(2-methoxyphenyl)-3-oxobutanamide,80675-49-6," In an acute oral toxicity study conducted according to the OECD-Guideline 423 in rats (BASF SE, 2008), the oral LD50 was determined to be > 2000 mg/kg bw. No mortality was observed. In an acute inhalation toxicity study according to the OECD-Guideline 403 in rats (BASF SE, 2013), the inhalative LD50 was determined to be > 2100 mg/m³ air. No mortality was observed. In an acute dermal toxicity study according to the OECD-Guideline 402 in rats (BASF SE, 2009), the dermal LD50 was determined to be > 2000 mg/kg bw. No mortality was observed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ab91cc5-e362-4860-b3dc-169d2ece0c07/documents/4a0bd3ab-9047-4015-9a80-18ae1f782dac_38e12503-6e5f-4526-9647-802e03fd5a08.html,,,,,, 2-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(2-methoxyphenyl)-3-oxobutanamide,80675-49-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ab91cc5-e362-4860-b3dc-169d2ece0c07/documents/4a0bd3ab-9047-4015-9a80-18ae1f782dac_38e12503-6e5f-4526-9647-802e03fd5a08.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(2-methoxyphenyl)-3-oxobutanamide,80675-49-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ab91cc5-e362-4860-b3dc-169d2ece0c07/documents/4a0bd3ab-9047-4015-9a80-18ae1f782dac_38e12503-6e5f-4526-9647-802e03fd5a08.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-[(E)-2-(2-methoxy-5-nitrophenyl)diazen-1-yl]-N-(2-methoxyphenyl)-3-oxobutanamide,80675-49-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ab91cc5-e362-4860-b3dc-169d2ece0c07/documents/4a0bd3ab-9047-4015-9a80-18ae1f782dac_38e12503-6e5f-4526-9647-802e03fd5a08.html,,inhalation,discriminating conc.,"2,100 mg/m3",no adverse effect observed, 2-ethoxy-2-methylbutane,919-94-8,"The oral NOAEL of TAEE is 100 mg/kg bw/day based on the increased ALT activity in females and significant increased relative liver weights accompanied by diffuse enlargement of the hepatocytes without the normal zonal pattern in males at mid- and high-dose levels, and increased adrenal weights in both sexes at the high dose level (observed in a subacute toxicity study).For the inhalation route, no TAEE specific data are available. Therefore, data of the structural analogues TAME (2-methoxy-2-methylbutane) and ETBE (2-ethoxy-2-methylpropane) were considered. The (lower) inhalation NOAEC reported for TAME, 250 ppm (1060 mg/m3), based on organ (liver, adrenals and kidneys) weight increases (rats and mice) and histopathological liver effects (mice) will be used for the derivation of the long-term inhalation DNEL for systemic effects for TAEE. The introduction of an additional safety factor in order to take into account the uncertainty for using the data on TAME to derive a DNEL for TAEE is considered to be unnecessary based on the available data. Only correction for molecular weight (102 g/mol for TAME vs. 116 g/mol for TAEE) will be applied. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b29ef4de-43b8-426a-a4b1-2088f33fe4e9/documents/618744c5-761f-4003-8cd0-7f954ca5806f_b847da6c-0f96-4681-8274-d78e924d532d.html,,,,,, 2-ethoxy-2-methylbutane,919-94-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b29ef4de-43b8-426a-a4b1-2088f33fe4e9/documents/618744c5-761f-4003-8cd0-7f954ca5806f_b847da6c-0f96-4681-8274-d78e924d532d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 2-ethoxy-2-methylbutane,919-94-8,The acute oral LD50 of TAEE is greater than 2000 mg/kg bw. The acute inhalation LC50 of TAEE is greater than 23.2 mg/l. The acute dermal LD50 is expected to be greater than 2000 mg/kg bw.Available human data on acute inhalation toxicity of TAME and ETBE showed a lower NOAEC for ETBE compared to TAME. The data on ETBE show minor complaints of sensory effects and pulmonary function changes at 50 ppm (210 mg/m3). Based on these data a NOAEC of 25 ppm (105 mg/m3) is established for ETBE. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b29ef4de-43b8-426a-a4b1-2088f33fe4e9/documents/b68e22b9-a5e5-45e4-b502-027b9313e29e_b847da6c-0f96-4681-8274-d78e924d532d.html,,,,,, 2-ethoxy-2-methylbutane,919-94-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b29ef4de-43b8-426a-a4b1-2088f33fe4e9/documents/b68e22b9-a5e5-45e4-b502-027b9313e29e_b847da6c-0f96-4681-8274-d78e924d532d.html,,oral,LD50,"2,000 mg/kg bw",, 2-ethoxy-2-methylbutane,919-94-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b29ef4de-43b8-426a-a4b1-2088f33fe4e9/documents/b68e22b9-a5e5-45e4-b502-027b9313e29e_b847da6c-0f96-4681-8274-d78e924d532d.html,,dermal,LD50,"2,000 mg/kg bw",, 2-ethoxy-2-methylbutane,919-94-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b29ef4de-43b8-426a-a4b1-2088f33fe4e9/documents/b68e22b9-a5e5-45e4-b502-027b9313e29e_b847da6c-0f96-4681-8274-d78e924d532d.html,,inhalation,LC50,"23,200 mg/m3",, "Butane-1,2,3,4-tetracarboxylic acid",1703-58-8," Combined repeated dose repro-devp. study was performed to determine the oral toxic nature of 1,2,3,4 butane tetra carboxylic acid upon repeated exposure by oral route. Female Sprague Dawley rats were exposed to the test chemical from gd 6 to gd 19 at dose levels of 0, 250, 500 or 1000 mg/Kg/day. The doses for the main study were selected from preliminary acute toxicity and developmental study. The treated animals were observed for mortality, clinical signs, body weight changes, food and water intake, organ weight changes and gross pathology. Treatment related mortality occurred in 4% (1/24) in 1000 mg/Kg/day females. All remaining females survived the treatment. Treatment related clinical signs included weight loss which occurred in all groups and showed increasing frquency and/or severity with increasing dose on individual days during the treatment period. Piloerection was observed in ≤ 4 females/day at 1000 mg/Kg/day. Rooting in the cage bedding after dosing suggested an aversion to the sensory properties of the 500 and 1000 mg/Kg/day dose formulations (≤ 3 500 mg/Kg/day females/day, and ≤ 5 1000 mg/Kg/day females/ day). Alopecia was noted with a low incidence in all groups but showed no apparent relationship to BTCA exposure. Maternal body weight was comparable among groups on gd 0 and 6 (i.e. prior to the initiation of dosing). On gd 9, 12, 15, 18, and 19, maternal body weights at the low and mid doses were not affected (98.8 to 100.8% of concurrent controls), but maternal body weight at the high dose was significantly lower than the vehicle control on each of these days, except gd 9. On gd 20, maternal body weight at the high dose was significantly below the vehicle control. Decreases in maternal body weight became larger with repeated dosing, and the maximum reductions occurred at the end of the dosing period (gd 18, 19, and 20). Thus, the effect of BTCA on maternal body weight was restricted to the 1000 mg/Kg/day dose group and the magnitude of this effect was relatively small. Maternal relative feed intake was transiently reduced at 1000 mg/kg/day from gd 6 to 9 and at 500 mg/kg/day from gd 12 to 15, although no changes were noted for the treatment period as a whole. Maternal relative water intake was increased at 1000 mg/kg/day for gd 12 to 15, 18 to 19, 19 to 20, and the treatment period as a whole. Gravid uterine weight and maternal relative liver weight were not affected. Absolute maternal liver weight exhibited a decreasing trend but showed no significant differences between control. Based on the observations made, the No Observed Adverse Effect Level (NOAEL) for 1,2,3,4 butane tetra carboxylic acid is considered to be 500 mg/Kg/day when Sprague Dawley rats were exposed to the test chemical repeatedly by gavage route for 14 days. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d6ebffd-f6d5-4eec-9c81-617230c882d5/documents/2bfe7723-2e56-429f-8bbf-5da63ef9f8ce_54dd65a7-c271-4049-858b-aeb942111825.html,,,,,, "Butane-1,2,3,4-tetracarboxylic acid",1703-58-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d6ebffd-f6d5-4eec-9c81-617230c882d5/documents/2bfe7723-2e56-429f-8bbf-5da63ef9f8ce_54dd65a7-c271-4049-858b-aeb942111825.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Butane-1,2,3,4-tetracarboxylic acid",1703-58-8," Acute oral toxicity: Acute oral toxicity test form NTP report, 1991 and NTRL report (OTS02800059),1980 was performed in rats COX-SD strain for a period of 14 days. The rats have 198-293gm and metal wire bottomed cages were used for the housing of rats. The chemical was given orally in the form of gavage in distilled water. 5 animals per sex per dose were used in 800, 1260, 1590, 2000 and 3170 mg/kg bw concentrations. Observations for gross signs were performed at regular intervals on the day of dosage and 5 days per week and thereafter for fourteen days. Necropsy of survivors was also done at termination of the study. Body weight were observed in animals some has constant weight and some has slight decrease in weight was observed. Moderate to severe congestion of the kidneys, adrenaIs , lungs, liver and intestines, scattered brownish lesions and/or erosion of the mucosa of the stomach (opaque portion), blanching of the mucosa of the stomach (opaque and translucent portions) and small intestine, paleness of the liver (underside of lobes) and brownish-gray coloration throughout the lungs. The acute oral LD50 of BTCA, when administered to 5 male COX-SD rats was considered to be 1740 mg/kgbw, with a confidence interval of 1330 to 2280 mg/kg bw. The acute oral LD50 of BTCA, when administered to 5 female COX-SD rats was considered to be 1620 mg/kgbw. Acute inhalation toxicity: Ten albino rats (five male and five female, COX-SD strain), weighing 230 to 272 grams, were exposed by the route of inhalation to undiluted butane tetracarboxylic acid in the powder form at a delivery flow concentration of approximately 8.19 mg per liter of air at a flow rate of 2.5 liters per minute for a period of 60 minutes plus 23 minutes for equilibration. All of the animals survived the 60 minute exposure and the 14 day observation period which followed. Bady weight gain was observed.No sign of gross toxicity was observed in any animal after post exposure observation period. 3 of the 10 animals shows lung congestion and other animals were not remarkable. On the basis of observation,the LD 50 value for butane tetracarboxylic acid was considered to be >8.19 mg/l of air concentations.   Acute dermal toxicity: Acute dermal toxicity test was performed in New Zealand Albino rabbits. Twelve New Zealand Albino rabbits, six males and six females were used and treated for 24 hrs. The rabbits weight was 2.30 to 2.86 kg were housed in metal cages elevated above droppings. Rabbits were given Purina Rabbit Chow and water ad libitium. Those animals which were without observable skin defects or irritation were used for experiment. One-half of the animals in each group were further prepared by making epidermal abrasions every two or three centimeters longitudinally over the area of exposure. A plastic binder was used onto each animal and 50% w/w suspension in isotonic saline, was introduced under the plastic binder. After the experiment the binder was removed and skin reactions were observed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d6ebffd-f6d5-4eec-9c81-617230c882d5/documents/72f3df23-4ef5-46cb-8483-95e532331122_54dd65a7-c271-4049-858b-aeb942111825.html,,,,,, "Butane-1,2,3,4-tetracarboxylic acid",1703-58-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d6ebffd-f6d5-4eec-9c81-617230c882d5/documents/72f3df23-4ef5-46cb-8483-95e532331122_54dd65a7-c271-4049-858b-aeb942111825.html,,oral,LD50,"1,620 mg/kg bw",adverse effect observed, "Butane-1,2,3,4-tetracarboxylic acid",1703-58-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d6ebffd-f6d5-4eec-9c81-617230c882d5/documents/72f3df23-4ef5-46cb-8483-95e532331122_54dd65a7-c271-4049-858b-aeb942111825.html,,dermal,LD50,"8,000 mg/kg bw",no adverse effect observed, "Butane-1,2,3,4-tetracarboxylic acid",1703-58-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d6ebffd-f6d5-4eec-9c81-617230c882d5/documents/72f3df23-4ef5-46cb-8483-95e532331122_54dd65a7-c271-4049-858b-aeb942111825.html,,inhalation,LC50,"8,190 mg/m3",no adverse effect observed, "bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] malate",66918-01-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f8310fa-3231-4e32-9cfd-0317d1bb1220/documents/7ad32d75-ac48-4009-a5da-88293324fa45_e10bb6e7-f88b-400c-ad60-4cb9ce5b4f95.html,,oral,LD50,"2,000 mg/kg bw",, "bis[2-(4,4-dimethylpentan-2-yl)-5,7,7-trimethyloctyl] malate",66918-01-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f8310fa-3231-4e32-9cfd-0317d1bb1220/documents/7ad32d75-ac48-4009-a5da-88293324fa45_e10bb6e7-f88b-400c-ad60-4cb9ce5b4f95.html,,dermal,LD50,"2,000 mg/kg bw",, "butanedioic acid, 2-octenyl",62568-82-5," Two oral repeat-dose studies were conducted with Octenylsuccinic Acid: 7-day non-GLP rangefinder study and GLP OECD 422 screen study (key study, Klimisch 1). The effects observed/NOAEL value obtained based on the key study were mainly localized to the portal of entry (stomach) and are a results of corrosive properties of the registered substance. The systemic kidney effects seen in the top dose animals were minimal and sporadic, and are also thought to be a result of the acid functionality of the registered substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64643cb4-0416-403d-ad41-c8d0bb863b99/documents/d10bed8d-94a9-4745-8787-3bd64be7148e_adc53ac3-5cb2-4397-a253-6a2c490c71be.html,,,,,, "butanedioic acid, 2-octenyl",62568-82-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64643cb4-0416-403d-ad41-c8d0bb863b99/documents/d10bed8d-94a9-4745-8787-3bd64be7148e_adc53ac3-5cb2-4397-a253-6a2c490c71be.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "butanedioic acid, 2-octenyl",62568-82-5," One acute oral LD50 GLP guideline study (Klimisch 1) is available for the Octenylsuccinic Acid. The estimated acute oral toxicity value for the registered substance was 1030 mg/kg body weight in female Wistar rats with approximate 95% confidence interval of 550 to 1750 mg/kg body weight. As the substance is corrosive to the skin, waivers for acute dermal and inhalation toxicity were utilized and studies were not conducted. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64643cb4-0416-403d-ad41-c8d0bb863b99/documents/054f83f9-4d26-424c-abea-23561515dc88_adc53ac3-5cb2-4397-a253-6a2c490c71be.html,,,,,, "butanedioic acid, 2-octenyl",62568-82-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64643cb4-0416-403d-ad41-c8d0bb863b99/documents/054f83f9-4d26-424c-abea-23561515dc88_adc53ac3-5cb2-4397-a253-6a2c490c71be.html,,oral,LD50,"1,030 mg/kg bw",adverse effect observed, "Butanedioic acid,sulfo-, mono (C16-18 and C18-unsatd. alkyl) ester, ammonium sodium salt",147993-66-6,"Subacute toxicity was tested with the registered substance in Wistar rats by oral gavage at 0 (propylene glycol), 100, 300, 1000/600 and 600 mg/kg bw/day (control, low dose, mid dose, high dose and high dose 2, respectively) in a supporting 3, 8 or 14-day dose range finding and at 0 (propylene glycol), 15, 45 and 90 mg/kg bw/day in a key combined repeated dose toxicity study with the reproductive/developmental toxicity screening test (OECD No. 422). The NOAEL for systemic toxicity of the parental generation was 15 mg/kg bw/day. A 90-day study was also available for the read across substance CAS No. 37294 -49 -8 (Disodium C-isodecyl sulphonatosuccinate) in the mono-ester subgroup, given to rats at 0.25, 1 and 4% in the diet. This study showed a NOAEL of 1% in the diet, corresponding with 750 mg/kg bw. For risk assessment, the lowest NOAEL of 15 mg/kg bw in the OECD 422 study with the registered substance was selected as this approach was considered most conservative.  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b43c94f-5efb-4386-bcbe-1e2a4c21dc6c/documents/d1485a8e-0750-4fc3-8a4f-d974600021a7_8f5f3ebe-9c75-4a2c-81aa-f92758d94dd5.html,,,,,, "Butanedioic acid,sulfo-, mono (C16-18 and C18-unsatd. alkyl) ester, ammonium sodium salt",147993-66-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b43c94f-5efb-4386-bcbe-1e2a4c21dc6c/documents/d1485a8e-0750-4fc3-8a4f-d974600021a7_8f5f3ebe-9c75-4a2c-81aa-f92758d94dd5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "Butanedioic acid,sulfo-, mono (C16-18 and C18-unsatd. alkyl) ester, ammonium sodium salt",147993-66-6,"Key studies for oral and dermal acute toxicity were performed, demonstrating LD50 >2000 mg/kg bw after both routes. Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulphosuccinates due to their substance properties and the risk management measures that are already implemented. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): High quality Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): High quality ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b43c94f-5efb-4386-bcbe-1e2a4c21dc6c/documents/3521130a-3d02-46a7-adf8-1fc6cc6ebc98_8f5f3ebe-9c75-4a2c-81aa-f92758d94dd5.html,,,,,, "Butanedioic acid,sulfo-, mono (C16-18 and C18-unsatd. alkyl) ester, ammonium sodium salt",147993-66-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b43c94f-5efb-4386-bcbe-1e2a4c21dc6c/documents/3521130a-3d02-46a7-adf8-1fc6cc6ebc98_8f5f3ebe-9c75-4a2c-81aa-f92758d94dd5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Butanedioic acid,sulfo-, mono (C16-18 and C18-unsatd. alkyl) ester, ammonium sodium salt",147993-66-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b43c94f-5efb-4386-bcbe-1e2a4c21dc6c/documents/3521130a-3d02-46a7-adf8-1fc6cc6ebc98_8f5f3ebe-9c75-4a2c-81aa-f92758d94dd5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts",90268-36-3,"A combined repeated dose and reproductive/developmental screening study which was performed with registered substance according to OECD guideline 422 showed NOAEL-levels of 60 mg/kg bw for paternal/maternal toxicity, 60 mg/kg bw for reproductive toxicity and 120 mg/kg bw for developmental toxicity.   Subchronic toxicity was tested with the registered substance in Wistar rats by dietary administration at 0, 500, 1500 and 4500 ppm in a key 90-day repeated dose toxicity study (OECD No. 408). The NOAEL was 1500 ppm for males and 4500 ppm for females, corresponding to a mean group intake of 96.5 mg/kg bw/day and 351.5 mg/kg bw/day, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b655576-b5e0-4915-9e67-32e137d9b1d0/documents/ad6b6e0c-b17f-45a5-bdd9-a8fa7089cf40_b4e804de-a032-4e76-8700-2ebb2bc90f26.html,,,,,, "Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts",90268-36-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b655576-b5e0-4915-9e67-32e137d9b1d0/documents/ad6b6e0c-b17f-45a5-bdd9-a8fa7089cf40_b4e804de-a032-4e76-8700-2ebb2bc90f26.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat "Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts",90268-36-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b655576-b5e0-4915-9e67-32e137d9b1d0/documents/ad6b6e0c-b17f-45a5-bdd9-a8fa7089cf40_b4e804de-a032-4e76-8700-2ebb2bc90f26.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,96.5 mg/kg bw/day,,rat "Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts",90268-36-3," Acute oral toxicity with test substance containing >= 90% act. ingr. was tested by gavage in 3 studies, showing LD50 between 580 and 1400 mg/kg for male and female rats in the key study; the test material was therefore considered harmful if swallowed. Acute dermal toxicity testing in rats did not reveal relevant changes and resulted in an LD50 > 2000 mg/kg bw. Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulfosuccinates due to their substance properties. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b655576-b5e0-4915-9e67-32e137d9b1d0/documents/ac858f46-a42b-4103-81ac-e14d2cfbe59d_b4e804de-a032-4e76-8700-2ebb2bc90f26.html,,,,,, "Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts",90268-36-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b655576-b5e0-4915-9e67-32e137d9b1d0/documents/ac858f46-a42b-4103-81ac-e14d2cfbe59d_b4e804de-a032-4e76-8700-2ebb2bc90f26.html,,oral,LD50,580 mg/kg bw,adverse effect observed, "Butanedioic acid, sulfo-, 1-C12-18-alkyl esters, disodium salts",90268-36-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b655576-b5e0-4915-9e67-32e137d9b1d0/documents/ac858f46-a42b-4103-81ac-e14d2cfbe59d_b4e804de-a032-4e76-8700-2ebb2bc90f26.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Butanedioic acid, sulfo-, 4-[2-[(2-hydroxyethyl)amino]ethyl] ester, N-C18-unsatd. acyl derivs., disodium salts",97862-28-7,"Key data for subacute toxicity were available from an oral (gavage) OECD 422 study in rats with read-across substance 'Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts', at dose levels given by oral gavage of 100, 300 and 1000 mg/kg bw/day. No relevant effects were observed at 100 and 300 mg/kg bw. At the dose of 1000 mg/kg bw, decreased body weight, increased serum ALAT and decreased serum albumin were observed as systemic changes, whereas macroscopic and microscopic stomach changes were observed as local changes, the latter without relevance to humans. NOAEL for paternal/maternal toxicity was 300 mg/kg bw/dayy.Key data for subchronic toxicity were available from an oral (diet) 90-day toxicity study in rats with read-aross substance 'Aspartic acid, N-(3-carboxy-1-oxo-sulfopropyl)-N-(C16-C18 (even numbered), C18unsaturated alkyl) tetrasodium salts' dosed at 0.5, 2 and 8 (reduced to 4) g/kg bw.day. The study showed decreased body weight gain, feed consumption and food efficiency at the mid dose and high dose levels and increased SGOT and SGPT (liver enzymes) at the high dose. Further hematuria was seen in the mid and high dose rats, various organ weights were decreased (e.g. decrease in adrenal and gonadal weight in high dose groups; decrease in pituitary weight in females of high dose group) and lower urinary tract pathology was seen in 2 high dosed rats. It thus appeared that the NOEL in the rat was below 0.50 g/kg/day, however 0.5 g act.ingr./kg bw/day can be considered as NOAEL. The NOAEL of 300 mg/kg bw in the OECD 422 study was considered as the most reliable and conservative NOAEL for risk characterisation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b8d8bc1-8f38-49ca-b0ad-711ca9d688b2/documents/IUC5-25c7e698-9662-4b8e-9b8c-3a596d8e66ca_663f049f-7db4-4dc8-9cae-425aef464c25.html,,,,,, "Butanedioic acid, sulfo-, 4-[2-[(2-hydroxyethyl)amino]ethyl] ester, N-C18-unsatd. acyl derivs., disodium salts",97862-28-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b8d8bc1-8f38-49ca-b0ad-711ca9d688b2/documents/IUC5-25c7e698-9662-4b8e-9b8c-3a596d8e66ca_663f049f-7db4-4dc8-9cae-425aef464c25.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Butanedioic acid, sulfo-, 4-[2-[(2-hydroxyethyl)amino]ethyl] ester, N-C18-unsatd. acyl derivs., disodium salts",97862-28-7,"Key studies for oral and dermal acute toxicity were performed with read-across substances 'Butanedioic acid, 2(or 3)-sulfo-, 4-[2-[(1-oxo(C12-C18(even numbered) and C18unsaturated)alkyl))amino]ethyl]esters, disodium salts' and 'Reaction products of ricinoleic acid with 2-aminoethanol and maleic acid and sodium hydrogensulfite' , demonstrating LD50 >2000 mg/kg bw after both routes. Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulphosuccinates due to their substance properties and the risk management measures that are already implemented. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b8d8bc1-8f38-49ca-b0ad-711ca9d688b2/documents/IUC5-9e83600c-6712-4dd1-b605-148085301711_663f049f-7db4-4dc8-9cae-425aef464c25.html,,,,,, "Butanedioic acid, sulfo-, 4-[2-[(2-hydroxyethyl)amino]ethyl] ester, N-C18-unsatd. acyl derivs., disodium salts",97862-28-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b8d8bc1-8f38-49ca-b0ad-711ca9d688b2/documents/IUC5-9e83600c-6712-4dd1-b605-148085301711_663f049f-7db4-4dc8-9cae-425aef464c25.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Butanedioic acid, sulfo-, 4-[2-[(2-hydroxyethyl)amino]ethyl] ester, N-C18-unsatd. acyl derivs., disodium salts",97862-28-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b8d8bc1-8f38-49ca-b0ad-711ca9d688b2/documents/IUC5-9e83600c-6712-4dd1-b605-148085301711_663f049f-7db4-4dc8-9cae-425aef464c25.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Butanedioic acid, sulfo-, monoesters with lanolin alcs., disodium salts",90268-43-2," Repeated oral toxicity:  Sulfosuccinate portion NOAEL of 30 mg/Kg, no effect on body weight, gross and microscopic  tissue observation, haematological, blood chemistry, or urinalysis parameters. The Lanoline portion (test performed on Cholesterol) didn't define specific toxicity on organs, especially for the liver. Repeated inhalation toxicity: data waiving  is based on exposure consideration. Repeated dermal toxicity: repeated application test on humans available (section 7.10.4) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0a3a2e2-f964-4b0e-8744-08b93e2afb83/documents/IUC5-09406cc3-3d5d-4183-ba0a-efadcc093b56_d55fc6b0-8031-42d0-9d2e-14d5db1a3fa6.html,,,,,, "Butanedioic acid, sulfo-, monoesters with lanolin alcs., disodium salts",90268-43-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0a3a2e2-f964-4b0e-8744-08b93e2afb83/documents/IUC5-09406cc3-3d5d-4183-ba0a-efadcc093b56_d55fc6b0-8031-42d0-9d2e-14d5db1a3fa6.html,Chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,dog "Butanedioic acid, sulfo-, monoesters with lanolin alcs., disodium salts",90268-43-2, Acute oral toxicity: LD50 = 2000 mg/Kg Acute inhalation toxicity: waiving Acute dermal toxicity: LD50 > 2000 mg/Kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0a3a2e2-f964-4b0e-8744-08b93e2afb83/documents/IUC5-2b32b191-c1fd-4f21-96d6-a09450c7a965_d55fc6b0-8031-42d0-9d2e-14d5db1a3fa6.html,,,,,, "Butanedioic acid, sulfo-, monoesters with lanolin alcs., disodium salts",90268-43-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0a3a2e2-f964-4b0e-8744-08b93e2afb83/documents/IUC5-2b32b191-c1fd-4f21-96d6-a09450c7a965_d55fc6b0-8031-42d0-9d2e-14d5db1a3fa6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Butanedioic acid, sulfo-, monoesters with lanolin alcs., disodium salts",90268-43-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0a3a2e2-f964-4b0e-8744-08b93e2afb83/documents/IUC5-2b32b191-c1fd-4f21-96d6-a09450c7a965_d55fc6b0-8031-42d0-9d2e-14d5db1a3fa6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-amino-2,3-dimethylbutanenitrile",13893-53-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43b156f7-9a66-45ea-887d-6fcdffb079c5/documents/IUC5-21e3ad4a-3b3a-40c7-82dc-82e92636e4ea_9314c1ed-a190-463b-9b99-34dc4081757a.html,,oral,LD50,83 mg/kg bw,, "2-amino-2,3-dimethylbutanenitrile",13893-53-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43b156f7-9a66-45ea-887d-6fcdffb079c5/documents/IUC5-21e3ad4a-3b3a-40c7-82dc-82e92636e4ea_9314c1ed-a190-463b-9b99-34dc4081757a.html,,dermal,LD50,23 mg/kg bw,, "2-amino-2,3-dimethylbutanenitrile",13893-53-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43b156f7-9a66-45ea-887d-6fcdffb079c5/documents/IUC5-21e3ad4a-3b3a-40c7-82dc-82e92636e4ea_9314c1ed-a190-463b-9b99-34dc4081757a.html,,inhalation,LC50,340 mg/m3,, Lovastatin,75330-75-5,LD 50 > 1000 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2774b36-48f6-41dd-9e0e-4ea32c307e08/documents/IUC5-260ac1a2-d82d-4542-b7a9-01cf47f07e68_16c385db-ae1a-4d57-99ef-4b6c659a0384.html,,,,,, Lovastatin,75330-75-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2774b36-48f6-41dd-9e0e-4ea32c307e08/documents/IUC5-260ac1a2-d82d-4542-b7a9-01cf47f07e68_16c385db-ae1a-4d57-99ef-4b6c659a0384.html,,oral,LD50,"1,000 mg/kg bw",, sodium/triethanolamine 4-((2-hydroxyethyl)amino)-3-pentaproenyl-4-oxobutanoate,1424149-03-0, No adverse effect found up to the highest dose 750 mg/kg/day in oral subacute toxicity study in rats ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/714dcf45-6698-4225-ae6b-63230e1309e4/documents/66a65bc5-3b25-4b44-b220-c174947fe81a_4bd9baab-40ea-4562-8825-9983865df90c.html,,,,,, sodium/triethanolamine 4-((2-hydroxyethyl)amino)-3-pentaproenyl-4-oxobutanoate,1424149-03-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/714dcf45-6698-4225-ae6b-63230e1309e4/documents/66a65bc5-3b25-4b44-b220-c174947fe81a_4bd9baab-40ea-4562-8825-9983865df90c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat sodium/triethanolamine 4-((2-hydroxyethyl)amino)-3-pentaproenyl-4-oxobutanoate,1424149-03-0,No concern for acute toxicity ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/714dcf45-6698-4225-ae6b-63230e1309e4/documents/IUC5-9c71b3b8-caa7-4fbf-bdf4-fc73e2f6cf0a_4bd9baab-40ea-4562-8825-9983865df90c.html,,,,,, sodium/triethanolamine 4-((2-hydroxyethyl)amino)-3-pentaproenyl-4-oxobutanoate,1424149-03-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/714dcf45-6698-4225-ae6b-63230e1309e4/documents/IUC5-9c71b3b8-caa7-4fbf-bdf4-fc73e2f6cf0a_4bd9baab-40ea-4562-8825-9983865df90c.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, sodium/triethanolamine 4-((2-hydroxyethyl)amino)-3-pentaproenyl-4-oxobutanoate,1424149-03-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/714dcf45-6698-4225-ae6b-63230e1309e4/documents/IUC5-9c71b3b8-caa7-4fbf-bdf4-fc73e2f6cf0a_4bd9baab-40ea-4562-8825-9983865df90c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium(trialkyloxy)titanium phosphate,109037-78-7, Results of a Repeated Dose Toxicity Study Oral are reported. A testing proposal for a Sub-Chronic Toxicity Study Oral is also provided. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7971059d-9894-467e-bfaa-7ab512176662/documents/a607f6ba-14ca-47ba-8a84-4bdb4e4977cb_a23ae038-4c32-4032-907e-19da20b02804.html,,,,,, Butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium(trialkyloxy)titanium phosphate,109037-78-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7971059d-9894-467e-bfaa-7ab512176662/documents/a607f6ba-14ca-47ba-8a84-4bdb4e4977cb_a23ae038-4c32-4032-907e-19da20b02804.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat Butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium(trialkyloxy)titanium phosphate,109037-78-7,"Acute toxicity via oral route, according to Annex V method: LD50 >5000 mg/kgAcute toxicity via dermal route, according to Annex V method: LD50 > 2000 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7971059d-9894-467e-bfaa-7ab512176662/documents/2d0d2a75-6ad1-44b2-bc69-1bebd085593b_a23ae038-4c32-4032-907e-19da20b02804.html,,,,,, Butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium(trialkyloxy)titanium phosphate,109037-78-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7971059d-9894-467e-bfaa-7ab512176662/documents/2d0d2a75-6ad1-44b2-bc69-1bebd085593b_a23ae038-4c32-4032-907e-19da20b02804.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Butyl (dialkyloxy(dibutoxyphosphoryloxy))titanium(trialkyloxy)titanium phosphate,109037-78-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7971059d-9894-467e-bfaa-7ab512176662/documents/2d0d2a75-6ad1-44b2-bc69-1bebd085593b_a23ae038-4c32-4032-907e-19da20b02804.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Butyl (S)-2-hydroxypropionate,34451-19-9," Suitable data is available for butyl-S-lactate. A repeated dose inhalation toxicity study in male Wistar rats with butyl-S-lactate revealed no systemic effects and thus the NOAEC (systemic) is considered to be greater than 600 mg/m³. Local irritation of the nasal epithelium was reported only in animals of the high (600 mg/m³) concentration group. Therefore, the NOAEC (local) is considered to be 200 mg/m³. To further assess the repeated dose toxicity of the butyl-S-lactate, a read-across approach was pursued. Suitable data from the source substances n-butanol and n-butyl acetate were used. Moreover, to assess the toxic potential of the other primary metabolite, lactic acid, the calcium salt of lactic acid, calcium lactate, was also used as a read-across partner. In a sub-chronic oral repeated dose toxicity study with n-butanol the oral NOAEL in rats was considered to be 125 mg/kg bw/day (corresponding to 247 mg/kg bw/d butyl-S-lactate). In a sub-chronic repeated dose inhalation toxicity study, the NOAEC for male and female rats was considered to be 500 ppm after exposure to n-butyl acetate (equals 2400 mg/m³, corresponding to 3020 mg/m³ butyl-S-lactate). No adverse effects were reported in a sub-chronic study (equivalent to OECD 408) conducted with the calcium salt of lactic acid, calcium lactate in rats by oral administration via drinking water. The NOAEL in this study is considered to be 4500 mg/kg bw/day for both sexes. Moreover, based on the data presented in IUCLID chapter 7.9.1 the source substances n-butyl acetate and n-butanol do not elicit neurotoxic effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ab1bec1-9641-4294-8ad3-cc993edb9d65/documents/a39259a1-f843-457f-8027-feae852578c8_49e1531c-d590-43f5-a6d6-0aa89ed7e33f.html,,,,,, Butyl (S)-2-hydroxypropionate,34451-19-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ab1bec1-9641-4294-8ad3-cc993edb9d65/documents/a39259a1-f843-457f-8027-feae852578c8_49e1531c-d590-43f5-a6d6-0aa89ed7e33f.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,600 mg/m3,,rat Butyl (S)-2-hydroxypropionate,34451-19-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ab1bec1-9641-4294-8ad3-cc993edb9d65/documents/a39259a1-f843-457f-8027-feae852578c8_49e1531c-d590-43f5-a6d6-0aa89ed7e33f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,247 mg/kg bw/day,,rat Butyl (S)-2-hydroxypropionate,34451-19-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ab1bec1-9641-4294-8ad3-cc993edb9d65/documents/a39259a1-f843-457f-8027-feae852578c8_49e1531c-d590-43f5-a6d6-0aa89ed7e33f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,200 mg/m3,adverse effect observed,rat Butyl (S)-2-hydroxypropionate,34451-19-9," In an acute oral toxicity study conducted according to OECD guideline 401, groups of Wistar rats (5/sex) were given butyl-S-lactate (> 97% purity) as a single oral dose of 2000 mg/kg bw in maize oil. An oral LD50 value of greater than 2000 mg/kg bw, both in male and female rats was determined in this study. In an acute inhalation toxicity study, young adult Wistar rats (5/sex), were exposed by nose-only inhalation to aerosols of butyl-S-lactate at a concentration of 5.14 g/L in air for 4 hours. Based on the result from this key study, the LC50 is considered to be greater than 5.14 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ab1bec1-9641-4294-8ad3-cc993edb9d65/documents/037ee044-6f77-4e3a-bbb5-479889c696db_49e1531c-d590-43f5-a6d6-0aa89ed7e33f.html,,,,,, "Butyl 2-[[3-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-hydroxy-1-naphthyl]azo]benzoate",31778-10-6," PR208 This study is a valid investigation of the toxicological effects resulting from repeated oral-gavage administration of the test item to rats (according to OECD 422, GLP compliant). The test item was administered in vehicle (corn oil) at dosages of 100, 300, and 1000 mg/kg body weight/day, animals in control groups received the vehicle only. Test item was administered to male rats for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum (i.e. 54 days). No test item related effects of toxicological relevance were found at any dose level tested. Thus, the NOAEL for general toxicity in males and females and for reproduction/developmental toxicity is considered to be >=1000 mg/kg body weight. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fad29b17-2a31-4453-9834-0ace20735d5e/documents/900d9357-1fe2-4edc-b1a7-065791abfb45_6c31c94b-2ef8-4542-a1ec-6ff1004e8ec6.html,,,,,, "Butyl 2-[[3-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-hydroxy-1-naphthyl]azo]benzoate",31778-10-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fad29b17-2a31-4453-9834-0ace20735d5e/documents/900d9357-1fe2-4edc-b1a7-065791abfb45_6c31c94b-2ef8-4542-a1ec-6ff1004e8ec6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Butyl 2-[[3-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-hydroxy-1-naphthyl]azo]benzoate",31778-10-6," PR208 10 Female Wistar rats were exposed to 15000 mg test item/kg bw once by gavage. Animals were observed for a period of 14 days. No animal died within this time and clinical signs and body weight development were normal. Therefore the LD50 value is > 15000 mg/kg bw for female Wistar rats. RA from PB25 Under the conditions of the present study, a single oral application of the test item to female rats at a dose of 2000 mg/kg body weight was associated with no sign of toxicity or mortality. The LD50 for female rats is > 2000 mg/kg body weight. Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity nor signs of irritation. The dermal LD50 was determined to be > 2000 mg/ kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fad29b17-2a31-4453-9834-0ace20735d5e/documents/5218e55d-8dd5-456c-9ceb-676267cd7d2c_6c31c94b-2ef8-4542-a1ec-6ff1004e8ec6.html,,,,,, Butyl 3-mercaptopropionate,16215-21-7,"A 28-day oral toxicity study with the methyl ester of 3-mercaptopropionic acid (MMP) in rats showed only minor effects on organ weights as well as forestomach hyperplasia at the highest dose level (100 mg/kg/day). These effects are not adverse or relevant for human risk assessment. The NOAEL of MMP is equivalent to a NOAEL of 135 mg/kg/d for BuMP. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available key studies are reliable or reliable with restrictions (Klimisch 1 – 2) and were conducted according to or similar to guidelines. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c8e42bc-8748-4c5e-95e7-3e483999ad04/documents/07390121-9075-4841-b88b-69a16083515b_263b5908-a758-43d8-88ad-8f364bf435d3.html,,,,,, Butyl 3-mercaptopropionate,16215-21-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c8e42bc-8748-4c5e-95e7-3e483999ad04/documents/07390121-9075-4841-b88b-69a16083515b_263b5908-a758-43d8-88ad-8f364bf435d3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,135 mg/kg bw/day,,rat Butyl 3-mercaptopropionate,16215-21-7,"Based on the available data in the category, the oral LD50 of BuMP is predicted to be 262 mg/kg bw, the dermal LD50 is predicted to be >2000 mg/kg bw, the inhalation LC50 is predicted to be 2.85 mg/L air. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c8e42bc-8748-4c5e-95e7-3e483999ad04/documents/3bd64839-f9e1-4b65-b293-7dcfb40f02e1_263b5908-a758-43d8-88ad-8f364bf435d3.html,,,,,, Butyl 3-mercaptopropionate,16215-21-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c8e42bc-8748-4c5e-95e7-3e483999ad04/documents/3bd64839-f9e1-4b65-b293-7dcfb40f02e1_263b5908-a758-43d8-88ad-8f364bf435d3.html,,oral,LD50,262 mg/kg bw,adverse effect observed, Butyl 3-mercaptopropionate,16215-21-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c8e42bc-8748-4c5e-95e7-3e483999ad04/documents/3bd64839-f9e1-4b65-b293-7dcfb40f02e1_263b5908-a758-43d8-88ad-8f364bf435d3.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Butyl 3-mercaptopropionate,16215-21-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c8e42bc-8748-4c5e-95e7-3e483999ad04/documents/3bd64839-f9e1-4b65-b293-7dcfb40f02e1_263b5908-a758-43d8-88ad-8f364bf435d3.html,,inhalation,LC50,2.85 mg/m3,adverse effect observed, "Butyl 4,4-bis(tert-butyldioxy)valerate",995-33-5," OECD 407 study The objective of this study was to evaluate the potential toxicity of4,4-bis(tert-butyldioxy)valerate(Luperox 230) following daily oral administration (gavage) to rats for 4 weeks (Michel, 2017). On completion of the treatment period, designated animals were held for a 2-week treatment-free period in order to evaluate the reversibility of any findings. This study was designed based on OECD No. 407 guideline. Two groups of five male and five female Sprague-Dawley rats and one group of ten male and ten females Sprague-Dawley rats were treated daily by the oral route (gavage) with the test item, at dose-levels of 30, 100 and 300 mg/kg/day, respectively for 4 weeks. Another group of ten animals per sex received the vehicle alone (corn oil) and as acted as a control group. The test item was administered as a solution in the vehicle under a constant dosage-volume of 5 mL/kg/day. The actual test item concentrations in the dose formulations prepared for use in Weeks 1 and 4 were determined using a Gas Chromatography with FID detection analytical method. The animals were checked daily for mortality and clinical signs. Detailed clinical examinations were performed weekly and a Functional Observation Battery (FOB) was conducted in Week 4. Body weight was recorded once pre-test, on the first day of treatment and then weekly. Food consumption was recorded weekly throughout the dosing period. Hematology, blood biochemistry urinalysis and thyroid hormone investigations were performed at the end of the treatment and treatment-free periods (for blood biochemistry and thyroid hormones). The estrous cycle was determined for all females sacrificed at the end of the treatment period, over 4 consecutive days. On completion of the treatment period, the animals were sacrificed and a full macroscopic post-mortem examination was performed. Designated organs were weighed and selected tissues were preserved. A microscopic examination was performed on designated tissues from the control- and high-dose animals and on liver and thyroids in both sexes and kidneys of males from the low- and intermediate-dose animals sacrificed at the end of the treatment period. Actual concentrations of the test item in the administered dose formulations analyzed in Weeks 1 and 4 remained within an acceptable range (-2% to +1%) when compared to the nominal concentrations. No test item was observed in the control dose formulation. No test item-related deaths occurred during the study. Test item-related clinical signs such as ptyalism, reflux at dosing and thin appearance were observed in females given 300 mg/kg/day. No neurologic, autonomic or behavioral changes that could be related to the treatment were observed on Day 26 during the FOB assessment phase. Body weight and body weight gain were unaffected in both sexes by the test item treatment. Food consumption was unaffected by the test item treatment in both sexes. Estrous cycle was unaffected by the test item treatment. At hematology investigations, no test item-related changes were noted. Test item-related changes of minor toxicological importance in blood biochemistry parameters consisted of higher sodium, total protein, total cholesterol levels and lower glucose and triglycerides levels. These findings were no longer observed at the end of the treatment-free period in both sexes but lower inorganic phosphorus and proteins levels were observed in males given 300 mg/kg/day. Lower urinary pH value was considered to be of minor toxicological importance due to the minimal amplitude and isolated nature, was noted in males given 300 mg/kg/day. At histopathology, the test item administration at 300 mg/kg/day induced slight or moderate, reversible centrilobular hepatocellular hypertrophy in both sexes. This correlated at 300 mg/kg/day with reversible moderate increases in liver weights in both sexes and macroscopic enlargement and increased lobular pattern in males. There was also minimal, reversible hypertrophy of thyroid follicular cells in both sexes, correlated with increased thyroid weights in males. Both liver and thyroid hypertrophy were not considered as adverse, but rather adaptive changes. In the kidneys from males only, there was an increased incidence and severity of tubular hyaline droplets positively stained with an antibody to alpha-2u-globulin, and correlated with partially reversible increased kidney weights. At the end of the treatment-free period, microscopic tubular hyaline droplets were still increased in incidence compared to controls. This renal finding specific to the male rat is considered to be non-relevant for human. The test item administration at 100 mg/kg/day induced minimal centrilobular hepatocellular hypertrophy in two males and one female in the liver and minimal increases in kidney weights in males only. The test item administration at 30 mg/kg/day did not induce any macroscopic or organ weight changes. The toxicity of4,4-bis(tert-butyldioxy)valerate(Luperox 230) was evaluated after daily administration (gavage) to rats at dose-levels of 30,100 and 300 mg/kg/day for 4 weeks. On completion of the treatment period, designated animals were held for a 2-week treatment-free period in order to evaluate the reversibility of any findings. Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) after the 4-week treatment period was established at 300 mg/kg/day.   OECD 421 study The potential (repro)toxic effects of4,4-bis(tert-butyldioxy)valerate(Luperox 230) was evaluated following daily oral administration (gavage), to male and female rats from before mating, through mating and, for females, through gestation until Day 14 post-partum (p.p.) inclusive (Bentz, 2017). Three groups of 10 male and 10 female (groups 2 to 4) Sprague-Dawley rats received LUPEROX® 230 daily by oral (gavage) administration before mating, through mating and, for the females, through gestation until Day 14p.p.The test item was administered as a solution in the vehicle, corn oil, at dose-levels of 100, 300 and 750 mg/kg/day. Another group of 10 males and 10 females received the vehicle alone, under the same experimental conditions and acted as a control group. A constant dose-volume of 5 mL/kg/day was used. The concentrations of the dose formulations were checked in study Weeks 1, 3, 6 and 9. The animals were checked twice daily for mortality and morbidity and once daily for clinical signs during the treatment period. Body weight and food consumption were recorded once a week during pre-mating and mating periods (food consumption not during mating), and during gestation on Days 0, 7, 14 and 20 post-coitum (p.c.) and lactation on Days 1, 4, 8 and 13 p.p. Thyroid hormone (TSH and T4) plasma levels were determined on the day of sacrifice in parental males and in Day 14 p.p. pups. Males were sacrificed after at least 11 weeks of treatment and females on Day 15p.p. Final body weights and selected organs weights (kidneys, liver, thyroids with parathyroids and male reproductive organs) were recorded and a macroscopic post-mortem examination of the principal thoracic and abdominal organs was performed, with particular attention paid to the reproductive organs. A microscopic examination was performed on kidneys, liver, ovaries (with oviducts), epididymides and/or testes in the control and high-dose groups, on liver, thyroids and/or kidneys in all-dose groups, on alpha2u-globulin protein immunostained kidneys of control and high-dose males, and on all macroscopic lesions. No test item was observed in the control dose formulations and the test item concentrations in the analyzed dose formulations were within an acceptable range of variations. There were no unscheduled deaths of parental animals in test item groups. Test item-related clinical signs consisted in piloerection and/or round back in a total of 4 females at 750 mg/kg/day, chromodaccryorrhea in 3/10 males at 300 mg/kg/day and at 750 mg/kg/day, and mainly ptyalism in all males and females at 750 mg/kg/day. There were no toxicologically significant effects on mean body weight in either sex but in males a lower mean body weight gain over the treatment period at 750 mg/kg/dayvs.controls (+211gvs.+255g, p < 0.05) was recorded. At this dose, mean food consumption was lower than in controls in the first week of treatment for both sexes (-18% for males, p < 0.01, and -28% for females, p < 0.001) but there were no toxicologically significant effects at 100 and 300 mg/kg/day on this parameter. During the 2 weeks of estrous cycle evaluation before mating, 5/10 females had an estrous ending at least after 3 days at 750 mg/kg/day and 2/10 at 300 mg/kg/day, vs.none in controls. There were no effects on estrous cycles at 100 mg/kg/day considered to be of toxicological significance. There were no effects on mean T4 level. At 750 mg/kg/day and when compared with controls, mean TSH plasma concentration in F0 males was 2-fold higher. This result correlated with thyroid microscopic results and was considered to be an indirect effect of the test item through the increase in hepatic metabolism. There were no effects at 100 and 300 mg/kg/day on mean TSH level. At 750 mg/kg/day, there were findings in the liver (mainly adverse hepatocellular degeneration/necrosis; adverse hyperplasia of bile ducts in females only; hepatocellular hypertrophy correlated with increased weights and gross enlargement; periportal inflammatory cells and pigment in females), kidneys in males only (adverse tubular degeneration/necrosis; hyaline droplets in tubular epithelium correlated with increased weights; tubular basophilia and dilation) and thyroid glands (follicular cell hypertrophy correlated with increased weights). At 300 mg/kg/day, there were findings in the liver (non-adverse hepatocellular hypertrophy correlated with increased weights), kidneys in males only (non-adverse hyaline droplets in tubular epithelium correlated with increased weights; non-adverse tubular basophilia and dilation) and thyroid glands (non-adverse follicular cell hypertrophy correlated with increased weights in males). At 100 mg/kg/day, there were findings in the liver (non-adverse hepatocellular hypertrophy correlated with increased weights in males only), kidneys in males only (non-adverse hyaline droplets in tubular epithelium) and thyroid glands (non-adverse follicular cell hypertrophy). Pup viability index on Day 4p.p.was low at 750 mg/kg/day (89.6%). This test item effect was considered as adverse. 4,4-bis(tert-butyldioxy)valerate(Luperox 230) was administered daily by gavage to male and female Sprague-Dawley rats for 4 weeks before mating, during mating and, for males until 11 weeks of treatment have elapsed, for females through gestation and lactation until Day 14p.p., at dose-levels of 100, 300 and 750 mg/kg/day. Under the experimental conditions and results of this study, the No Observed Adverse Effect Level (NOAEL) for parental toxicity was considered to be 300 mg/kg/day for males and females based on the absence of adverse effects up to this dose and on the adverse effects on liver (both sexes) and kidneys (males) at microscopy at 750 mg/kg/day.   Range-finding study A preliminary study evaluated the potential toxicity of4,4-bis(tert-butyldioxy)valerate(Luperox 230) following daily oral administration (gavage) to rats for 2 weeks in order to assist the selection of dose-levels for a further 4-week toxicity study to be performed in this species (Michel, 2016). Three groups of five male and five female Sprague-Dawley rats were treated daily by the oral route (gavage) with the test item, at dose-levels of 100, 300 or 1000 mg/kg/day for 2 weeks. Another group of five males and five females received the vehicle alone (corn oil) and acted as a control group. The test item was administered as a solution in the vehicle under a constant dosage-volume of 5 mL/kg/day. The animals were observed daily for mortality and clinical signs. Body weight was recorded once pre-test, on the first day of treatment and then at least twice a week. Food consumption was recorded at least twice a week. On completion of the treatment period, the animals were sacrificed and a full macroscopic post-mortem examination was performed. Designated organs were weighed and selected tissue specimens were preserved. No microscopic examination was performed. No unscheduled deaths occurred during the study. Ptyalism was observed in 2/5 high-dose males and females. This sign is commonly observed when a test item is administered by oral gavage and was considered not to be an adverse effect. Body weight and body weight change were statistically significantly lower in females given 1000 mg/kg/day during the first 4 days only, when compared to controls, 177vs.203 g and -17vs.5 g respectively. Body weight change was statistically significantly lower, when compared to controls, in males given 1000 mg/kg/day during the first 4 days (-32%) but without any effect on body weight. Food consumption was statistically significantly lower in both sexes at 1000 mg/kg/day during the first 4 days only (-20% and -57% in males and females respectively).In females, this lower food consumption correlated with a decrease in body weight and body weight change. At necropsy, higher liver weights were noted at all dose-levels in males and at 300 and 1000 mg/kg/day in females. An enlargement of the liver was observed in one male at 300 mg/kg/day and in most animals from both sexes at 1000 mg/kg/day. These changes were considered to be test item-related. Consequently, under the experimental conditions of the study, the dose-levels of 300 mg/kg/day was chosen as high dose-level for the 4-week toxicity study in this species because at 1000 mg/kg/day, all males and 3/5 females showed enlargement of the liver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f3c5f47-19b5-4b01-a6d5-4763e22e9433/documents/e297cd04-f121-4faf-82e3-f393a613b6d3_5fcdc42c-7fea-4106-9fb4-55b256db273b.html,,,,,, "Butyl 4,4-bis(tert-butyldioxy)valerate",995-33-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f3c5f47-19b5-4b01-a6d5-4763e22e9433/documents/e297cd04-f121-4faf-82e3-f393a613b6d3_5fcdc42c-7fea-4106-9fb4-55b256db273b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Butyl 4,4-bis(tert-butyldioxy)valerate",995-33-5," Acute oral toxicity The potential acute toxicity of4,4-bis(tert-butyldioxy)valerate(Luperox 230) was evaluated following asingle oral administration (gavage) to rats (Gerbeix, 2016). The study was conducted in compliance with the OECD guideline No. 423 and the principles of Good Laboratory Practice. The test item was administered once by oral route (gavage) to two groups of three fasted female Sprague-Dawley rats under a dosage-volume of 10 mL/kg. The test item was prepared in corn oil. Based on available test item toxicity data, the starting dose-level of 2000 mg/kg was chosen. After the first assay, as no toxicity was observed, the results were confirmed in other females. Each animal was observed at least once a day for mortality and clinical signs for 15 days. Body weight was recorded on Day 1 and then on Days 8 and 15.On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination. Macroscopic lesions preserved in 10% buffered formalin were destroyed at the finalization of the study report. No unscheduled deaths occurred during the study. At 2000 mg/kg, hunched posture together with dyspnea were observed on Day 1, 1 to 3 hours and 4 hours after treatment in 1/6 females. Hunched posture persisted from Day 2 to Day 6 in this animal. No clinical signs were noted in the other 5/6 females treated at the same dose-level. No relevant differences from historical control data were noted in the body weight and body weight change of test item-treated animals over the study period. There were no macroscopic findings related to treatment in the study. Under the experimental conditions of this study, the oral LD0 of 4,4-bis(tert-butyldioxy)valerate (Luperox 230) was higher than 2000 mg/kg in rats.   Acute dermal toxicity The acute dermal toxicity of 4,4-bis(tert-butyldioxy)valerate (LUPEROX 230M50) was evaluated in rats according to OECD guideline No. 402 and the principles of Good Laboratory Practice Regulations (Manciaux, 2001). The test substance was applied at the dose-levels of 2000 mg/kg and 4000 mg/kg (as LUPEROX 230M50) to the skin of groups of ten Sprague-Dawley rats (five males and five females each). The application was performed with the undiluted test substance, taking into consideration that its specific gravity was 0.84 g/ml. The test site was then covered by a semi-occlusive dressing for 24 hours. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test substance. All animals were subjected to necropsy. No clinical signs and no deaths were observed during the study. No cutaneous reactions were observed. A reduced weight gain or a slight body weight loss was seen in females given 4000 mg/kg. The body weight gain of the other animals was not affected by treatment with the test substance. No apparent abnormalities were observed at necropsy in any animal. The dermal LD0  of LUPEROX  230M50 is equal to or higher than 4000 mg/kg in rats, which corresponds to a dose-level of 2000 mg/kg of 4,4-bis(tert-butyldioxy)valerate. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f3c5f47-19b5-4b01-a6d5-4763e22e9433/documents/7e9e7949-dcee-441c-9132-9cd3b0fb95c2_5fcdc42c-7fea-4106-9fb4-55b256db273b.html,,,,,, "Butyl 4,4-bis(tert-butyldioxy)valerate",995-33-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f3c5f47-19b5-4b01-a6d5-4763e22e9433/documents/7e9e7949-dcee-441c-9132-9cd3b0fb95c2_5fcdc42c-7fea-4106-9fb4-55b256db273b.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Butyl 4,4-bis(tert-butyldioxy)valerate",995-33-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f3c5f47-19b5-4b01-a6d5-4763e22e9433/documents/7e9e7949-dcee-441c-9132-9cd3b0fb95c2_5fcdc42c-7fea-4106-9fb4-55b256db273b.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Butyl carbamate,592-35-8, The oral LD50 of the test substance was determined to be 690 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41c7dc5b-c759-4ffe-99c1-fa5c30e11b7a/documents/b2ed6a7c-464d-4216-a066-ee8f84b10595_6d94484e-7071-4a57-b202-adf15bc37b06.html,,,,,, Butyl carbamate,592-35-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41c7dc5b-c759-4ffe-99c1-fa5c30e11b7a/documents/b2ed6a7c-464d-4216-a066-ee8f84b10595_6d94484e-7071-4a57-b202-adf15bc37b06.html,,oral,LD50,690 mg/kg bw,adverse effect observed, Butyl chloroformate,592-34-7,"In a 28 day inhalation repeated dose toxicity study (OECD 412, GLP) the NOAEC was determined to be 28.2 (highest dose tested) and 10.0 µg/L, for systemic and local effects respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c0f4424-c4a1-4723-9a94-92da383e1770/documents/IUC5-65ade755-2d25-4cd1-bf42-c13a745bd449_4f600326-00bc-475f-af80-bd70e06880ee.html,,,,,, Butyl chloroformate,592-34-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c0f4424-c4a1-4723-9a94-92da383e1770/documents/IUC5-65ade755-2d25-4cd1-bf42-c13a745bd449_4f600326-00bc-475f-af80-bd70e06880ee.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,28.2 mg/m3,,rat Butyl chloroformate,592-34-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c0f4424-c4a1-4723-9a94-92da383e1770/documents/IUC5-65ade755-2d25-4cd1-bf42-c13a745bd449_4f600326-00bc-475f-af80-bd70e06880ee.html,Repeated dose toxicity – local effects,inhalation,NOAEC,10 mg/m3,adverse effect observed,rat Butyl chloroformate,592-34-7,In an acute oral toxicity study was the LD50 was determined to be 1325 mg/kg bw.In an acute inhalation toxicity study the LC50 was determined to be more than 200 ppm for 1 hour exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c0f4424-c4a1-4723-9a94-92da383e1770/documents/IUC5-8aae381e-2985-47e4-8986-070be087bebc_4f600326-00bc-475f-af80-bd70e06880ee.html,,,,,, Butyl chloroformate,592-34-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c0f4424-c4a1-4723-9a94-92da383e1770/documents/IUC5-8aae381e-2985-47e4-8986-070be087bebc_4f600326-00bc-475f-af80-bd70e06880ee.html,,oral,LD50,"1,325 mg/kg bw",adverse effect observed, Butyl ethyl ether,628-81-9," In the study by Smyth et al., 1951 an oral LD50 of 1870 mg/kg bw was reported for rats after a single application of butyl ethyl ether. Two studies are available to assess the acute inhalation toxicity of butyl ethyl ether. In the study by Marsh & Leake, 1950 the LC50 was determined to be 153000 mg/m³ in mice. In the study Smyth et al., 1951 six rats were exposed for 4 hours to 1000 ppm of butyl ethyl ether. Animals then were observed for 14 days. No mortality occurred. Thus, the LC50 can be considered to be greater than 1000 ppm (equals 4170 mg/m³). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d257c8ee-7a3d-47dc-858f-1742ac06fde9/documents/62695033-2631-4222-a540-a06d8b460a33_01be2e5f-6da9-462a-8d8d-2ec7ea4bbe14.html,,,,,, Butyl ethyl ether,628-81-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d257c8ee-7a3d-47dc-858f-1742ac06fde9/documents/62695033-2631-4222-a540-a06d8b460a33_01be2e5f-6da9-462a-8d8d-2ec7ea4bbe14.html,,oral,LD50,"1,870 mg/kg bw",adverse effect observed, Butyl nitrite,544-16-1, Acute oral toxicity: Key study. Test method similar to OECD 401. The LD50 of the test item is 83 mg/kg body weight by oral route in the rat. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4af591d-2cb1-46fd-8a7e-1f6fcd38c9e1/documents/6aa9c153-93d7-4330-ad83-2d06b1c78898_69b3d4d7-8770-4782-9060-132e49201871.html,,,,,, Butyl nitrite,544-16-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4af591d-2cb1-46fd-8a7e-1f6fcd38c9e1/documents/6aa9c153-93d7-4330-ad83-2d06b1c78898_69b3d4d7-8770-4782-9060-132e49201871.html,,oral,LD50,83 mg/kg bw,adverse effect observed, Butyl toluene-4-sulphonate,778-28-9, Acute Oral Toxicity Under the conditions of the study the acute oral LD50 was determined to exceed 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47eda284-5059-43ef-bd20-a0bf25610faa/documents/94435e7a-951a-45e8-b8ad-dbeb46461b7d_0e178cf1-3ffc-4d9a-b278-e0830a2c309a.html,,,,,, Butyl toluene-4-sulphonate,778-28-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47eda284-5059-43ef-bd20-a0bf25610faa/documents/94435e7a-951a-45e8-b8ad-dbeb46461b7d_0e178cf1-3ffc-4d9a-b278-e0830a2c309a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Butylchlorodihydroxystannane,13355-96-9," Read across to structurally similar substance monobutyltin trichloride (MBTC, CAS No.: 1118-46-3). Repeated oral toxicity The NOAEL was determined to be 1500 mg/kg diet (equivalent to 96 mg/kg bw/day in males and 101 mg/kg bw/day in females). Repeated inhalation toxicity The NOAEL was determined to be 16.18 mg test material/m³ (7.17 mg Sn/m³). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/beb6c0df-d14f-441a-a7c7-d0bac6719319/documents/b109b209-b783-44de-bd65-b3d1c167db7c_5e5267ed-c1e3-4413-9da6-8a4652b921c3.html,,,,,, Butylchlorodihydroxystannane,13355-96-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/beb6c0df-d14f-441a-a7c7-d0bac6719319/documents/b109b209-b783-44de-bd65-b3d1c167db7c_5e5267ed-c1e3-4413-9da6-8a4652b921c3.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,16.18 mg/m3,,rat Butylchlorodihydroxystannane,13355-96-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/beb6c0df-d14f-441a-a7c7-d0bac6719319/documents/b109b209-b783-44de-bd65-b3d1c167db7c_5e5267ed-c1e3-4413-9da6-8a4652b921c3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,96 mg/kg bw/day,,rat Butylchlorodihydroxystannane,13355-96-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/beb6c0df-d14f-441a-a7c7-d0bac6719319/documents/b109b209-b783-44de-bd65-b3d1c167db7c_5e5267ed-c1e3-4413-9da6-8a4652b921c3.html,Repeated dose toxicity – local effects,inhalation,LOAEC,3 mg/m3,adverse effect observed,rat Butylchlorodihydroxystannane,13355-96-9," Oral, Braun (1978): Under the conditions of the study the acute oral LD50 of the test material was determined to be greater than 20 g/kg, the highest dose tested. Dermal, Calandra (1976): Under the conditions of the study the acute dermal LD50 was greater than 2000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/beb6c0df-d14f-441a-a7c7-d0bac6719319/documents/2cb32f26-eb97-4439-84e4-7d1f3c8724a5_5e5267ed-c1e3-4413-9da6-8a4652b921c3.html,,,,,, Butylchlorodihydroxystannane,13355-96-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/beb6c0df-d14f-441a-a7c7-d0bac6719319/documents/2cb32f26-eb97-4439-84e4-7d1f3c8724a5_5e5267ed-c1e3-4413-9da6-8a4652b921c3.html,,oral,LD50,"20,000 mg/kg bw",no adverse effect observed, Butylchlorodihydroxystannane,13355-96-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/beb6c0df-d14f-441a-a7c7-d0bac6719319/documents/2cb32f26-eb97-4439-84e4-7d1f3c8724a5_5e5267ed-c1e3-4413-9da6-8a4652b921c3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Butylethylmagnesium,62202-86-2," The substance is corrosive, pyrophoric and water reactive. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/108bd76e-464a-4d4f-83c8-66fb654f623d/documents/f51f976a-ddca-4ede-9c25-29a891bf4df3_7fb404c8-0b24-4464-b4ba-2059738ff84b.html,,,,,, Butylethylmagnesium,62202-86-2," Corrosive. Reactions of magnesium alkyls with liquids are in some cases explosion like. Most prominent example is reaction with water, which liberates for short chain alkyls highly flammable gases within seconds (alkyl groups with five carbon atoms and less). But any substance bearing protic hydrogen react in similar fashion, like alcohols, acids (organic and inorganic), etc. Thus, exposure of mammalian species to magnesium alkyls would not generate meaningful data, and no acute toxicity studies are required for this substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/108bd76e-464a-4d4f-83c8-66fb654f623d/documents/IUC5-667e7b4c-39c2-46fe-834e-8fc55bc6db17_7fb404c8-0b24-4464-b4ba-2059738ff84b.html,,,,,, Butylhydroxyoxostannane,2273-43-0," Read across to structurally similar substance monobutyltin trichloride (MBTC, CAS No.: 1118-46-3). Repeated oral toxicity The NOAEL was determined to be 1500 mg/kg diet (equivalent to 96 mg/kg bw/day in males and 101 mg/kg bw/day in females). Repeated inhalation toxicity The NOAEL was determined to be 16.18 mg test material/m³ (7.17 mg Sn/m³). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3d376f7-cd99-4423-87b6-1c5084ece74b/documents/1d893cb6-c104-436d-ac6a-f82e3477bd5c_f848fc47-106d-48dc-a926-c51c6ba62edb.html,,,,,, Butylhydroxyoxostannane,2273-43-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3d376f7-cd99-4423-87b6-1c5084ece74b/documents/1d893cb6-c104-436d-ac6a-f82e3477bd5c_f848fc47-106d-48dc-a926-c51c6ba62edb.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,16.18 mg/m3,,rat Butylhydroxyoxostannane,2273-43-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3d376f7-cd99-4423-87b6-1c5084ece74b/documents/1d893cb6-c104-436d-ac6a-f82e3477bd5c_f848fc47-106d-48dc-a926-c51c6ba62edb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,96 mg/kg bw/day,,rat Butylhydroxyoxostannane,2273-43-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3d376f7-cd99-4423-87b6-1c5084ece74b/documents/1d893cb6-c104-436d-ac6a-f82e3477bd5c_f848fc47-106d-48dc-a926-c51c6ba62edb.html,Repeated dose toxicity – local effects,inhalation,LOAEC,3 mg/m3,adverse effect observed,rat Butylhydroxyoxostannane,2273-43-0," Oral, Braun (1978): Under the conditions of the study the acute oral LD50 of the test material was determined to be greater than 20 g/kg, the highest dose tested. Dermal, Calandra (1976): Under the conditions of the study the acute dermal LD50 was greater than 2000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3d376f7-cd99-4423-87b6-1c5084ece74b/documents/4f3cb450-f58c-4aeb-88fb-c61a019a36b6_f848fc47-106d-48dc-a926-c51c6ba62edb.html,,,,,, Butylhydroxyoxostannane,2273-43-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3d376f7-cd99-4423-87b6-1c5084ece74b/documents/4f3cb450-f58c-4aeb-88fb-c61a019a36b6_f848fc47-106d-48dc-a926-c51c6ba62edb.html,,oral,LD50,"20,000 mg/kg bw",no adverse effect observed, Butylhydroxyoxostannane,2273-43-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3d376f7-cd99-4423-87b6-1c5084ece74b/documents/4f3cb450-f58c-4aeb-88fb-c61a019a36b6_f848fc47-106d-48dc-a926-c51c6ba62edb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Butyltris[(2-ethyl-1-oxohexyl)oxy]stannane,23850-94-4, No adverse effects determinated in an OECD 421 study in the higest dose level at 96 mg MBTC kg be/day. The doese is equivalent to 206 mg MBT(2-EH)_3 / kg bw day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bef2d21b-79c1-4195-989b-1af06aedcccd/documents/db323806-e943-4db0-acc0-7997ecb9e6a5_2a69e7de-6b7b-426a-8294-de298c6be8e2.html,,,,,, Butyltris[(2-ethyl-1-oxohexyl)oxy]stannane,23850-94-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bef2d21b-79c1-4195-989b-1af06aedcccd/documents/db323806-e943-4db0-acc0-7997ecb9e6a5_2a69e7de-6b7b-426a-8294-de298c6be8e2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,206 mg/kg bw/day,,rat Butyltris[(2-ethyl-1-oxohexyl)oxy]stannane,23850-94-4, Acute Oral Toxicity: Auletta (1989) Under the conditions of the study the acute oral LD50 was greater than 5000 mg/kg in males and 3200 mg/kg in females. Acute Dermal Toxicity Under the conditions of the study the acute dermal LD50 of the test material was greater than 8000 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bef2d21b-79c1-4195-989b-1af06aedcccd/documents/e5b064de-204f-4052-97c9-0539a1b24d57_2a69e7de-6b7b-426a-8294-de298c6be8e2.html,,,,,, Butyltris[(2-ethyl-1-oxohexyl)oxy]stannane,23850-94-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bef2d21b-79c1-4195-989b-1af06aedcccd/documents/e5b064de-204f-4052-97c9-0539a1b24d57_2a69e7de-6b7b-426a-8294-de298c6be8e2.html,,oral,LD50,"3,200 mg/kg bw",adverse effect observed, Butyltris[(2-ethyl-1-oxohexyl)oxy]stannane,23850-94-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bef2d21b-79c1-4195-989b-1af06aedcccd/documents/e5b064de-204f-4052-97c9-0539a1b24d57_2a69e7de-6b7b-426a-8294-de298c6be8e2.html,,dermal,LD50,"8,000 mg/kg bw",no adverse effect observed, Butyric anhydride,106-31-0,"The oral LD50 of butyric acid was determined to be 1632 mg/kg bw in rats (BASF, 1978).Hydrolysis study data, provided in section 5.1.2 will be used to demonstrate that butyric anhydride in an aqueous environment will undergo almost immediate hydrolysis to butyric acid. Thus, study data from butyric acid will be used to satisfy all data points in section 7, as water will be present in all of the studies. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0939f86-5b65-4ce1-962c-703582bf5e31/documents/IUC5-2598eaeb-0b5f-4998-8778-3ad99cd7481f_ec2cb629-5851-4135-93ce-3069908c362f.html,,,,,, Butyric anhydride,106-31-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0939f86-5b65-4ce1-962c-703582bf5e31/documents/IUC5-2598eaeb-0b5f-4998-8778-3ad99cd7481f_ec2cb629-5851-4135-93ce-3069908c362f.html,,oral,LD50,"1,632 mg/kg bw",, Butyryl chloride,141-75-3, In rats the oral LD50 was 1000-1470 mg/kg bw; in rabbits the dermal LD50 was >2000 mg/kg bw. Based on the results of an inhalation-risk test an LC50 between 3.6 - 5.6 mg/L was calculated using Haber's rule. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21db3e16-4b8e-42bc-800b-a8bf2be2a113/documents/6dcbe754-7571-4aaf-a84f-d153a83aab4a_5641c42c-4fe7-435f-9dc6-7d277097f963.html,,,,,, "C,C'-azodi(formamide)",123-77-3," An oral 90-day study was performed in rats according to OECD/EC guidelines and GLP principles. Based on this study the sub-chronic NOAEL (oral route) is concluded to be 300 mg/kg bw/day for males and at least 1000 mg/kg bw/day for females. One dietary study on ADCA and on its main metabolite (biurea) is also available (Oser, 1965) and supports this result.  Reliable sub-chronic inhalation studies in rats and mice are available. No effect has been observed and no target organ has been identified in both species after 13-week inhalation at the highest levels tested (200mg/m3). Therefore, the NOAEL in rats and mice after sub-chronic (13 weeks) inhalation is concluded to be 200mg/m3.    ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef81c6b3-e205-4b5c-883d-97911ef8bf91/documents/IUC5-4ded807d-64f0-4b78-b6fe-45a928574930_bc021e96-5c89-49d0-abd3-4ac9d4f34b03.html,,,,,, "C,C'-azodi(formamide)",123-77-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef81c6b3-e205-4b5c-883d-97911ef8bf91/documents/IUC5-4ded807d-64f0-4b78-b6fe-45a928574930_bc021e96-5c89-49d0-abd3-4ac9d4f34b03.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "C,C'-azodi(formamide)",123-77-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef81c6b3-e205-4b5c-883d-97911ef8bf91/documents/IUC5-4ded807d-64f0-4b78-b6fe-45a928574930_bc021e96-5c89-49d0-abd3-4ac9d4f34b03.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,200 mg/m3,,rat "C,C'-azodi(formamide)",123-77-3,Acute oral toxicity:  No deaths seen at 5000 mg/kg bodyweight in rats.Acute inhaled toxicity:  No deaths seen in rats exposed to 0.52 mg/L air for 4 hours.Acute dermal toxicity:  No deaths seen in rats exposed at 2000 mg/kg for 24 hours. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef81c6b3-e205-4b5c-883d-97911ef8bf91/documents/IUC5-70cd5a18-da98-4902-a888-19bd8fd33cc9_bc021e96-5c89-49d0-abd3-4ac9d4f34b03.html,,,,,, "C,C'-azodi(formamide)",123-77-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef81c6b3-e205-4b5c-883d-97911ef8bf91/documents/IUC5-70cd5a18-da98-4902-a888-19bd8fd33cc9_bc021e96-5c89-49d0-abd3-4ac9d4f34b03.html,,oral,discriminating dose,"5,000 mg/kg bw",, "C,C'-azodi(formamide)",123-77-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef81c6b3-e205-4b5c-883d-97911ef8bf91/documents/IUC5-70cd5a18-da98-4902-a888-19bd8fd33cc9_bc021e96-5c89-49d0-abd3-4ac9d4f34b03.html,,dermal,discriminating dose,"2,000 mg/kg bw",, "C,C'-azodi(formamide)",123-77-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef81c6b3-e205-4b5c-883d-97911ef8bf91/documents/IUC5-70cd5a18-da98-4902-a888-19bd8fd33cc9_bc021e96-5c89-49d0-abd3-4ac9d4f34b03.html,,inhalation,discriminating conc.,520 mg/m3,, C.I. Solvent Red 119,12237-27-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81659560-4cca-409b-b7e2-336006841148/documents/5139dd56-a6a7-4373-a0b0-b235d67f2844_46da8af3-5c85-4fdb-b201-2e1f691cabdb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "C16-18 (evennumbered, C18 unsaturated) alkyl bis(2-hydroxyethyl) amine oxide",2097729-23-0," We have not tested Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides for repeat dose toxicity although in an OECD421 study the NOAEL for systemic toxicity in the parental animals was 75mg/kg bodyweight / day with the top dose of 200 reduced after 10 days to 150 mg/kg product reduced bodyweights particularly in the males. Therefore read across has been used to establish a NOAEL for systemic toxicity. The read across source for this end point is from 2,2’-(octadec-9-enylimino)diethanol which is structurally similar to the target organism although is an amine ethoxylate and not an amine ethoxylate N-oxide. The QSAR models are not able to predict the properties of the N-oxide so this cannot be used to support the read across. However both the 28 day and 90 day studies for 2,2’-(octadec-9-enylimino)diethanol had the same 150mg/kg top dose as the target and both showed a NOAEL of 30 mg/kg bodyweight per day. Also to support this there is an old 90 day study for Ethanol, 2.2’-iminobis,-N-tallow alkyl derivatives, CAS No 61791-44-4, which is the same tallow amine ethoxylate as the target but again not the N-oxide, however it showed a very similar NOAEL of 35 mg/kg body weight per day. Toxicity was related to reduce bodyweight gain in males at the top dose and foamy macrophages seen in mesenteric lymph nodes and the lamina propria of the in the jejunum and duodenum. The similarity in their structure with similar carbon chain lengths (derived from natural fatty acids), their top dose levels being the same and the effects seen in the top dose of bodyweight loss, support the use of the 30 mg/kg bodyweight /day oral NOAEL from the 90 day study on 2,2’-(octadec-9-enylimino)diethanol as the basis for the derivations of DNELs for Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4998950d-3080-4712-bf7b-2fc94caa4b07/documents/04168247-8b84-4e18-9ed1-e924211fe415_30ef4f66-a164-4c50-bbb3-f6aa811fc6d8.html,,,,,, "C16-18 (evennumbered, C18 unsaturated) alkyl bis(2-hydroxyethyl) amine oxide",2097729-23-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4998950d-3080-4712-bf7b-2fc94caa4b07/documents/04168247-8b84-4e18-9ed1-e924211fe415_30ef4f66-a164-4c50-bbb3-f6aa811fc6d8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "C16-18 (evennumbered, C18 unsaturated) alkyl bis(2-hydroxyethyl) amine oxide",2097729-23-0," The is no acute toxicity data for Ethanol, 2,2’-iminobis-N-tallow alkyl derivatives, N-oxides, however there is data for a close structural analogue 2,2’-(octadec-9-enylimino)diethanol.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4998950d-3080-4712-bf7b-2fc94caa4b07/documents/0faf7e25-fec3-4152-af61-719532f1eeb6_30ef4f66-a164-4c50-bbb3-f6aa811fc6d8.html,,,,,, "C16-18 (evennumbered, C18 unsaturated) alkyl bis(2-hydroxyethyl) amine oxide",2097729-23-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4998950d-3080-4712-bf7b-2fc94caa4b07/documents/0faf7e25-fec3-4152-af61-719532f1eeb6_30ef4f66-a164-4c50-bbb3-f6aa811fc6d8.html,,oral,LD50,"2,394 mg/kg bw",adverse effect observed, "C16-18-(even numbered)-alkyl fatty acid, compound with C16-18-(even numbered)-alkylamine",1428547-35-6,"For the registered salt:- 14d range-finder (OECD 407): NOAEL 150 mg/kg bw/day Z-octadec-9-enylamines (CAS: 112-90-3)- 14d range-finder (OECD 407): NOAEL 25 mg/kg bw/day - Key study 28d (OECD 407, GLP): NOAEL 3.25 mg/kg bw/day (corresponding to 6.7 mg/kg bw/day of the registered salt.Tallow alkylamine (CAS: 61790-33-8)- 14d range-finder (OECD 407): NOAEL 62.5 mg/kg bw/day - 28d (OECD 407, GLP): NOAEL 12.5 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/857fef0b-4bdd-4165-b1e8-20a9b5a55496/documents/85ccf560-843f-4c05-89fe-85fd6f3a65f0_1a0b15b3-1dbc-48b3-83aa-43c57241aa4d.html,,,,,, "C16-18-(even numbered)-alkyl fatty acid, compound with C16-18-(even numbered)-alkylamine",1428547-35-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/857fef0b-4bdd-4165-b1e8-20a9b5a55496/documents/85ccf560-843f-4c05-89fe-85fd6f3a65f0_1a0b15b3-1dbc-48b3-83aa-43c57241aa4d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,6.7 mg/kg bw/day,,rat "C16-18-(even numbered)-alkyl fatty acid, compound with C16-18-(even numbered)-alkylamine",1428547-35-6,Acute oral toxicity data exhibited a low toxicity of the substance with an LD50 > 2000 mg/kg bw. No inhalative study is available but limited exposure is expected. Assessment of dermal acute toxicity was based on a read-across with C12 -18 -(even numbered)-alkylamines indicating also a low acute toxicity (LD50 > 2000 mg/kg body weight). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/857fef0b-4bdd-4165-b1e8-20a9b5a55496/documents/bf6e352a-e249-4c44-8ad4-61a0ef96b4ca_1a0b15b3-1dbc-48b3-83aa-43c57241aa4d.html,,,,,, "C16-18-(even numbered)-alkyl fatty acid, compound with C16-18-(even numbered)-alkylamine",1428547-35-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/857fef0b-4bdd-4165-b1e8-20a9b5a55496/documents/bf6e352a-e249-4c44-8ad4-61a0ef96b4ca_1a0b15b3-1dbc-48b3-83aa-43c57241aa4d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "C16-18-(even numbered, C18-unsaturated)-alkylamines acetates",1273322-47-6,"Only limited data are available for the primary alkylamine C16-18-(even numbered)-alkylamines with regard to repeated dose toxicity. However, 14-day extended dose-range-finder screening studies, have illustrated clear consistencies in the toxicity profile within alkylamine acetates on one side and their corresponding alkyl amines on the other side. Therefore the 28-day oral toxicity test with C16-18-(even numbered, saturated and unsaturated)- alkylamines can be used for hazard and risk characterization purposes based on read-across principles. Groups of five male and female rats received the test item by oral gavage at dose levels of 0, 3.25, 12.5 or 50 mg/kg body weight per day for a period of 28 days. At a dose of 50 mg/kg body weight per day clinical signs such as gait abnormalities, reduction in body weight gain and clinical pathology findings indicating mild toxic effects on the liver and kidneys were found. Effects observed at the mid dose level (12.5 mg/kg) were slight reduction in growth. At the low dose group of 3.25 mg/kg body weight per day no effects were observed. Hence, the NOAEL of this study was placed at 3.25 mg/kg body weight per day. This value is considered to be conservative but valid also for C16-18-(even numbered)-alkylamine acetates and will be used for all relevant exposures by route-to-route extrapolation for the registration substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cebe2f3d-3369-414a-b90a-1f7d23c11dcb/documents/IUC5-e35d0336-647b-4ebd-a1d5-fa2b4b0af7ea_a873d516-61ef-49ce-9021-43ce372b5ca8.html,,,,,, "C16-18-(even numbered, C18-unsaturated)-alkylamines acetates",1273322-47-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cebe2f3d-3369-414a-b90a-1f7d23c11dcb/documents/IUC5-e35d0336-647b-4ebd-a1d5-fa2b4b0af7ea_a873d516-61ef-49ce-9021-43ce372b5ca8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,3.25 mg/kg bw/day,,rat "C16-18-(even numbered, C18-unsaturated)-alkylamines acetates",1273322-47-6,"There are no human data on acute toxicity for the test item. In animals, test results with this substance are available for the oral route of exposure indicating a LD50 cut-off value of 2000 mg/kg body weight. With regard to the dermal route of exposure, results from analogous primary alkylamines revealed a LD50 greater 2000 mg/kg body weight. Testing of the inhalation route is waived based on the physico-chemical characteristics ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cebe2f3d-3369-414a-b90a-1f7d23c11dcb/documents/IUC5-579a75d9-ece8-415f-95c2-f31305214476_a873d516-61ef-49ce-9021-43ce372b5ca8.html,,,,,, "C16-18-(even numbered, C18-unsaturated)-alkylamines acetates",1273322-47-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cebe2f3d-3369-414a-b90a-1f7d23c11dcb/documents/IUC5-579a75d9-ece8-415f-95c2-f31305214476_a873d516-61ef-49ce-9021-43ce372b5ca8.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, "C16-18-(even numbered, saturated and unsaturated)-alkylamines",1213789-63-9,"A GLP compliant 28-day oral toxicity test with (Z)-octadec-9-enylamines (Genamin OL 100 D) according to OECD TG 407 was identified as key study. Groups of five male and female rats recieved the test item by oral gavage at dose levels of 0, 3.25, 12.5 or 50 mg/kg body weight per day for a period of 28 days. At a dose of 50 mg/kg body weight per day clinical signs such as gait abnormalities, reduction in body weight gain and clinical pthology findings indicating mild toxic effects on the liver and kidneys were found. Effects observed at the mid-dose level (12.5 mg/kg) were slight reduction in growth. At the low dose group of 3.25 mg/kg body weight per day no effects were observed. Hence, the NOAEL of this study was placed at 3.25 mg/kg body weight per day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a5f1ed9-3da1-4b95-b031-6559d6c76d27/documents/IUC5-3349a26a-33ac-4eca-b871-20215203d6b0_545b9665-888a-403d-9c5d-4b998c5dfc06.html,,,,,, "C16-18-(even numbered, saturated and unsaturated)-alkylamines",1213789-63-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a5f1ed9-3da1-4b95-b031-6559d6c76d27/documents/IUC5-3349a26a-33ac-4eca-b871-20215203d6b0_545b9665-888a-403d-9c5d-4b998c5dfc06.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,3.25 mg/kg bw/day,,rat "C16-18-(even numbered, saturated and unsaturated)-alkylamines",1213789-63-9,"The test material Noram O ((Z)-octadec-9-enylamine) was tested for acute oral toxicity in a GLP compliant study according to OECD test guideline 401. The test item was applied via gavage to Wistar rats at doses of 200, 500, 1000 and 2000 mg/kg body weight in corn oil as vehicle. Clinical signs during the 14 day observation period included: hypokinesia and/or sedation, piloerection and dyspnea, abdominal swelling and decreases in body weight gain. An LD50 of 1200 mg/kg body weight for male rats and 1689 mg/kg body weight for female rats was calculated. With regard to acute dermal toxicity, a LD50 value of greater 2000 mg/kg body weight from a guideline conform study on C12-18-(even numbered)-alkylamines can be assumed based on read-across. Data from an inhalation study with C12-18-(even numbered)-alkylamines indicate a 1hour LC50 greater 0.099 mg/L and will be used as read-across. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a5f1ed9-3da1-4b95-b031-6559d6c76d27/documents/IUC5-d895a364-a5a2-4a44-b454-efe808041c04_545b9665-888a-403d-9c5d-4b998c5dfc06.html,,,,,, "C16-18-(even numbered, saturated and unsaturated)-alkylamines",1213789-63-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a5f1ed9-3da1-4b95-b031-6559d6c76d27/documents/IUC5-d895a364-a5a2-4a44-b454-efe808041c04_545b9665-888a-403d-9c5d-4b998c5dfc06.html,,oral,LD50,"1,200 mg/kg bw",, "C16-18-(even numbered, saturated and unsaturated)-alkylamines",1213789-63-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a5f1ed9-3da1-4b95-b031-6559d6c76d27/documents/IUC5-d895a364-a5a2-4a44-b454-efe808041c04_545b9665-888a-403d-9c5d-4b998c5dfc06.html,,dermal,LD50,"2,000 mg/kg bw",, Cadmium,7440-43-9,"Available NOAELs from repeated dose oral and inhalation studies range between 0.12 - 3 mg/kg bw/day (studies with cadmium chloride) and 0.013. 10-3- 0.022 x 10-3mg/L (studies with cadmium oxide), respectively.Repeated dose toxicity of cadmium via the dermal route is not expected given the relatively low skin penetration of all forms of this metal. Also in view of the risk reduction measures which need to be taken as a result of the carcinogenicity of cadmium metal and some of the cadmium compounds, chronic dermal toxicity is not expected to be an issue for human health. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ecb88d5-fa0d-432b-802c-97a9998bd681/documents/IUC5-fc8cfb9d-44d4-440c-9018-c17ddf1fab7e_63199495-977d-435d-9d68-69a2b084838c.html,,,,,, Cadmium,7440-43-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ecb88d5-fa0d-432b-802c-97a9998bd681/documents/IUC5-fc8cfb9d-44d4-440c-9018-c17ddf1fab7e_63199495-977d-435d-9d68-69a2b084838c.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.013 mg/m3,,"hamster, Syrian" Cadmium,7440-43-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ecb88d5-fa0d-432b-802c-97a9998bd681/documents/IUC5-fc8cfb9d-44d4-440c-9018-c17ddf1fab7e_63199495-977d-435d-9d68-69a2b084838c.html,Chronic toxicity – systemic effects,oral,NOAEL,0.12 mg/kg bw/day,,monkey Cadmium,7440-43-9," Although original studies were not available, data for cadmium oxide and cadmium metal powder suggest that the slightly soluble or insoluble forms ofcadmium (like also cadmium hydroxide and cadmium carbonate) may present lower oral acute toxicity than the soluble cadmium compounds. To date, they are not classified for this endpoint. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ecb88d5-fa0d-432b-802c-97a9998bd681/documents/IUC5-5d67ffc1-9748-4052-9292-0bc1622ea6ea_63199495-977d-435d-9d68-69a2b084838c.html,,,,,, Cadmium,7440-43-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ecb88d5-fa0d-432b-802c-97a9998bd681/documents/IUC5-5d67ffc1-9748-4052-9292-0bc1622ea6ea_63199495-977d-435d-9d68-69a2b084838c.html,,oral,LD50,"2,330 mg/kg bw",, Cadmium,7440-43-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ecb88d5-fa0d-432b-802c-97a9998bd681/documents/IUC5-5d67ffc1-9748-4052-9292-0bc1622ea6ea_63199495-977d-435d-9d68-69a2b084838c.html,,inhalation,LC50,56 mg/m3,, Cadmium oxide,1306-19-0,"Available NOAELs from repeated dose oral and inhalation studies range between 0.12 - 3 mg/kg bw/day (studies with cadmium chloride) and 0.013. 10-3- 0.022 x 10-3mg/L (studies with cadmium oxide), respectively.Repeated dose toxicity of cadmium via the dermal route is not expected given the relatively low skin penetration of all forms of this metal. Also in view of the risk reduction measures which need to be taken as a result of the carcinogenicity of cadmium metal and some of the cadmium compounds, chronic dermal toxicity is not expected to be an issue for human health. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a672b94b-122b-4347-b997-1a89a3dceec1/documents/IUC5-328b26fb-b64e-4d2b-b26a-ea9dff0b3dcd_3eac68db-53fa-494d-a9fa-4b84efc0223d.html,,,,,, Cadmium oxide,1306-19-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a672b94b-122b-4347-b997-1a89a3dceec1/documents/IUC5-328b26fb-b64e-4d2b-b26a-ea9dff0b3dcd_3eac68db-53fa-494d-a9fa-4b84efc0223d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.013 mg/m3,,"hamster, Syrian" Cadmium oxide,1306-19-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a672b94b-122b-4347-b997-1a89a3dceec1/documents/IUC5-328b26fb-b64e-4d2b-b26a-ea9dff0b3dcd_3eac68db-53fa-494d-a9fa-4b84efc0223d.html,Chronic toxicity – systemic effects,oral,NOAEL,0.12 mg/kg bw/day,,monkey Cadmium oxide,1306-19-0,"Although original studies were not available, data for cadmium oxide and cadmium metal powder suggest that the slightly soluble or insoluble forms of cadmium (like also cadmium hydroxide and cadmium carbonate) may present lower oral acute toxicity. To date, they are not classified for this endpoint. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a672b94b-122b-4347-b997-1a89a3dceec1/documents/IUC5-926f1ced-7bb3-465d-a222-d51b0d13144b_3eac68db-53fa-494d-a9fa-4b84efc0223d.html,,,,,, Cadmium oxide,1306-19-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a672b94b-122b-4347-b997-1a89a3dceec1/documents/IUC5-926f1ced-7bb3-465d-a222-d51b0d13144b_3eac68db-53fa-494d-a9fa-4b84efc0223d.html,,oral,LD50,"2,330 mg/kg bw",, Cadmium oxide,1306-19-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a672b94b-122b-4347-b997-1a89a3dceec1/documents/IUC5-926f1ced-7bb3-465d-a222-d51b0d13144b_3eac68db-53fa-494d-a9fa-4b84efc0223d.html,,inhalation,LC50,56 mg/m3,, Cadmium selenide,1306-24-7," Acute Toxicity via Oral Route Key value determined in a GLP accredited laboratory study using acute toxic class method , in accordance with OECD GUIDELINES FOR TESTING OF CHEMICALS (420, adopted at 17th Dec. 2001), Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.bis. and EPA Health Effects Test Guidelines (OPPTS 870.1100), United States, EPA 712-C-98-190 (1998). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60749204-e396-4112-8565-d06a469137f9/documents/6651d20c-1e25-4c01-8c54-ffcb4831899f_65f747f2-4924-4e55-8547-16b70d128fea.html,,,,,, Cadmium selenide,1306-24-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60749204-e396-4112-8565-d06a469137f9/documents/6651d20c-1e25-4c01-8c54-ffcb4831899f_65f747f2-4924-4e55-8547-16b70d128fea.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Cadmium sulphate,10124-36-4,"Available NOAELs from repeated dose oral and inhalation studies range between 0.12 - 3 mg/kg bw/day (studies with cadmium chloride) and 0.013. 10-3- 0.022 x 10-3mg/L (studies with cadmium oxide), respectively.Repeated dose toxicity of cadmium via the dermal route is not expected given the relatively low skin penetration of all forms of this metal. Also in view of the risk reduction measures which need to be taken as a result of the carcinogenicity of cadmium metal and some of the cadmium compounds, chronic dermal toxicity is not expected to be an issue for human health. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6030773-fd2d-4b7c-85ae-7712bc8bfb87/documents/IUC5-44e1498f-a43e-4900-86ac-2d1b5e6834de_5852c167-9fa5-4eaf-a368-6cc72c555523.html,,,,,, Cadmium sulphate,10124-36-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6030773-fd2d-4b7c-85ae-7712bc8bfb87/documents/IUC5-44e1498f-a43e-4900-86ac-2d1b5e6834de_5852c167-9fa5-4eaf-a368-6cc72c555523.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.013 mg/m3,,"hamster, Syrian" Cadmium sulphate,10124-36-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6030773-fd2d-4b7c-85ae-7712bc8bfb87/documents/IUC5-44e1498f-a43e-4900-86ac-2d1b5e6834de_5852c167-9fa5-4eaf-a368-6cc72c555523.html,Chronic toxicity – systemic effects,oral,NOAEL,0.12 mg/kg bw/day,,monkey Cadmium sulphate,10124-36-4,"When administered orally, the water soluble cadmium chloride caused mortality at relatively low doses, with LD50s in mouse and rat ranging from 29 to 327 mg Cd/kg bw. On this basis, cadmium chloride has been classified asT; R25 (toxic if swallowed) in Annex I of Directive 67/548/EEC.Under GHS-CLP, the corresponding classification would be ‘Acute toxicity (oral) category 3; H301’. Although no animal studies are available, cadmium sulphate is also classified in Annex I asT; R25, which is justified given its comparable solubility to cadmium chloride. Cadmium nitrate, also highly water soluble, is at present not classified for acute oral toxicity but a similar classification should be considered. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6030773-fd2d-4b7c-85ae-7712bc8bfb87/documents/IUC5-b6e64b74-01fd-405f-b176-3f537401cda8_5852c167-9fa5-4eaf-a368-6cc72c555523.html,,,,,, Cadmium sulphate,10124-36-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6030773-fd2d-4b7c-85ae-7712bc8bfb87/documents/IUC5-b6e64b74-01fd-405f-b176-3f537401cda8_5852c167-9fa5-4eaf-a368-6cc72c555523.html,,oral,LD50,225 mg/kg bw,, Cadmium sulphate,10124-36-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6030773-fd2d-4b7c-85ae-7712bc8bfb87/documents/IUC5-b6e64b74-01fd-405f-b176-3f537401cda8_5852c167-9fa5-4eaf-a368-6cc72c555523.html,,inhalation,LC50,56 mg/m3,, Cadmium telluride,1306-25-8,"  Animal data:   Repeated dose toxicity, inhalation:     In a 28-Day Dose Range Finding Inhalation Toxicity Study (Nose-only) in the Rat, exposures to Cadmium telluride (CdTe) in the form of a dry aerosol at concentration levels of 0.003, 0.01, 0.03 and 0.09 mg/L were associated with adverse effects. The associated adverse effects at the lowest tested concentration were slight, transient tachypnea during the last week of the exposure, increase in lungs weights (by about 1.5-2 times), which correlated with minimal alveolar/interstitial/bronchiolar inflammation and minimal hyperplasia of the Type II pneumocytes. Since at the lowest possible concentration (0.003mg/L achieved by 2 hours exposure session to 0.01 mg/L) adverse effects on the respiratory tract were observed, a LOAEC of 3 mg/m3 could be set but no NOAEL could be determined in this study (Grosz, M 2013).   A full 28-day inhalation toxicity study (nose-only) in the rat was finalised by CiTox LAB Hungary Limited (Grósz, M 2015). The study followed the guideline OECD 412 and was conducted according to the principles of GLP. Doses were selected based on the previous results of the 28 -Day Dose Range Finding inhalation Toxicity Study (Grosz, M 2013)   Study Design The OECD 412 guideline requires that the substance to be tested has a Mass Median Aerodynamic Diameter(MMAD) < 3 µm to ensure that the substance is respirable under the conditions of the test. The substance that was tested had to be milled to achieve a suitable MMAD. Due to the large particle size of CdTe, the sample was therefore extensively abraded by milling and grinding with a Retsch Mixer Mill MM 400 before testing, to achieve a MMAD of 1.08 – 1.8 µm. This process significantly altered the substance to a size and form not representative of CdTe at manufacturing sites, as placed on the EU market and used downstream (information from exposure questionnaires sent to cadmium telluride downstream users). The dose levels chosen were 1 mg/m3, 0.3 mg/m3and 0.1 mg/m3as a result of dose range finding studies of 7-day and 28-day duration. Typically, in a nose only repeat dose study, the rats are exposed to the test concentration for 6 hours per day, however in this study an atmosphere generation at concentration <1 mg/m3could not be achieved. At concentrations < 1.0 mg/m3the laboratory could not achieve stability, reproducibility and accuracy of the gravimetric analysis, due to the standard commercial equipment available at the laboratory, which was designed to run at test concentrations in the > 1 mg/m3range. Therefore, the laboratory proposed to conduct the “full” study by reducing the exposure time at the 1 mg/m3dose level to achieve the 0.1 and 0.3 mg/m3dose levels. This was done by the application of Haber’s Rule/Law (concentration x time of exposure = dose). The final dosing strategy resulted in the situation where each group was exposed to a target concentration of 1 mg/m3and the exposure doses at 0.3 mg/m3and 0.1 mg/m3were achieved by reduction of the exposure time to 2 hours and 40 minutes respectively. Control animals were exposed for 6 hours/day to clean air. However, this dosing strategy does introduce a high level of uncertainty into this study and it is impossible to know if testing at the actual lower dose levels over 6 hours would give rise to a different toxicity profile. It would have been much more desirable to obtain the correct testing equipment in order to achieve the low dose levels. Finally, a further group of animals at the high dose were retained for 14-days post exposure to determine any reversibility of effects observed during the study. As cadmium and cadmium compounds are known to have a long clearance time from the lung, the choice of a 14-day reversibility period was on reflection, too short. A more useful reversibility period would have been 3 months. In conclusion, the study design does raise uncertainties which could have had a significant effect on the outcome of the study and the interpretation of the results. These are: i.                    Excessive milling and grinding required to achieve a respirable sample of CdTe. ii.                  The use of Haber’s Rule/Law to achieve the required dose levels at low concentrations.  Main Findings of the 28-day Repeat Dose Toxicity inhalation Study An exposure to Cadmium telluride (CdTe) in the form of a dry aerosol to Hannover Wistar rats for 28 consecutive days at concentration of 1 mg/m3 for 6 hours and 0.3 mg/m3 (achieved by exposure to the 1.0 mg/m3for two hours) was associated with the following findings, taken from the study report: i.                    Enlarged, grey mottled lungs and enlarged, grey coloured lung associated lymph, increase in lungs weight (absolute and relative values) in both sexes by approximately 94-106% (at 1 mg/m3) and 50-65% (0.3 mg/m3). ii.                  The above effect was correlated with minimal to mild diffuse alveolar/interstitial inflammation, accumulation of foamy alveolar macrophages and black cytoplasmic pigment in interstitial macrophages of the lungs.  iii.                Lymphoid hyperplasia and aggregates of macrophages, presence of black pigment in macrophages and degeneration/necrosis of the macrophages were found in the lung associated lymph nodes. iv.                Inflammatory changes of lungs were detectable by bronchoalveolar lavage. v.                  Increase in neutrophil granulocyte count in peripheral blood detected at haematology. vi.                These changes were still present following 14-day treatment free period.  vii.               Exposure at 0.1 mg/m3(achieved by exposure to the 1.0 mg/m3 for 40 minutes) resulted in increase of lungs weight by approximately 35-45% (males) and 20-24% (females), without any macroscopic observation, except enlarged lung associated lymph nodes. Microscopically minimal diffuse alveolar/interstitial inflammation was observed in lungs in 4 of 5 males and 4 of 5 females, in addition to mild changes in lung-associated lymph nodes (mild lymphoid hyperplasia and aggregates of macrophages, presence of black pigment). viii.             The LOAEL of this study was therefore determined to be 0.1 mg/m3, the lowest dose tested, and no NOAEL could be established.   There were no reported incidences of nasal irritation or irritation/cell damage in the lung. No investigation into the presence or incidence of fibrosis was carried out during the study or in the reversibility satellite group. Unlike the blood analysis, a full white cell count in the BAL fluid was not conducted. Some of the findings in this study are indicative of cadmium toxicity e.g. cell proliferation, hyperplasia, particle accumulation (long clearance rate). However, the duration of exposure in this study is too short to be conclusive and only partial histopathology was conducted as is typical for studies of this duration. This study was given a Klimisch score of 2 due to the dosing regime and the toxicological uncertainty of reducing the exposure period to achieve the low dose levels. The severe attrition of the substance to achieve a respirable dose also raises the question of the representativeness of the tested substance in comparison to the form placed and subsequently used on the EU market.       Repeated dose toxicity, oral:   As cadmium accumulates in tissues over time in a repeat dose study, a critical cumulative dose has to be achieved before toxicity is observed. The integrated testing strategy for cadmium telluride proposes to conduct a toxicokinetic study over 90 days to show that cadmium telluride does not cause an accumulation of cadmium in the kidney and liver (two sensitive target organs) and is therefore not bioavailable by the oral route.    In a 14-day pilot study (Dose Range Finding study) (Wagenaar, 2019), it was determined whether cadmium telluride up to 100 mg/kg bw/day (1500 ppm) was well tolerated, when given via diet for 14 days to Wistar Han rats and to provide data for the selection of the dose levels for a subsequent sub-chronic (90-day) oral toxicokinetic study. In addition, the cadmium and tellurium concentrations in the liver, kidney, faeces and urine were compared to the reference group (cadmium chloride). The following parameters and endpoints were evaluated in this study: clinical signs, body weights, food consumption, cadmium and tellurium concentrations in liver, kidney, urine and feces, gross necropsy findings and kidney and liver weights. For the cadmium telluride groups and reference group (cadmium chloride), the following was concluded: No mortality occurred during the study period. No treatment-related clinical signs were noted during daily detailed clinical observations. Body weights and body weight gain of treated animals remained in the same range as controls over the study period. Food consumption before or after correction for body weight was similar to the control level over the study period. Macroscopic observations at necropsy did not reveal any alterations that were considered to have arisen as a result of treatment. Organ weights and organ to body weight ratios of treated animals were considered to be similar to those of control animals. Based on the results of the tolerability study,administration of Cadmium telluride in diet was well tolerated in rats at levels up to 1500 ppm.    A 90-day toxicokinetic study in the rat was performed by Charles River Laboratories Den Bosch BV (Lourens, 2020). The study was in accordance to OECD Test Guideline 408 and was conducted according to the principles of GLP. The objective of the study was to determine the toxicology, accumulation and toxicokinetics of cadmium telluride in the rat in comparison to cadmium chloride as a reference substance. The dose levels were selected based on the study of Loeser and Lorke (1977) (https://doi.org/10.1016/0300 -483X(77)90067-1), a study that investigated the sub-chronic toxicity and accumulation of cadmium in the liver and kidney in the rat dosed with cadmium chloride in the diet at 30 ppm) and the results of a 14-day repeated dose range-finding toxicity study with oral exposure of cadmium telluride and cadmium chloride (cadmium telluride: 750; 1500 ppm, cadmium chloride: 30ppm) (Wagenaar 2019).   Study Design  In Weeks 1, 4 and 8 three animals/sex/test item group were sacrificed for bioanalytical purposes. Prior to sacrifice, blood, urine and faeces were collected to determine cadmium and tellurium content. In Week 13, the remaining animals were sacrificed for bioanalytical and toxicological assessment purposes. Control group animals were only sacrificed in Weeks 1 and 13.  Samples of diets were collected for analysis. Chemical analyses of dietary preparations were conducted on Weeks 1 and 6 to assess concentration and homogeneity. The following parameters and endpoints were evaluated in this study: clinical signs, body weights, food consumption, clinical pathology parameters (haematology, coagulation and clinical chemistry), toxicokinetic parameters (see section 5.1 Toxicokinetics), gross necropsy findings and organ weights.   Main Findings of the 90-day Toxicokinetic study    At 750 ppm Cadmium telluride, no test item-related findings were observed. At 1500 ppm Cadmium telluride, no test item-related clinical signs were observed. A trend towards a non-adverse slightly lower body weight and body weight gain was seen in males. Results of the haematology examinations showed lower mean levels of red blood cells and reticulocytes, red blood cell distribution width, haemoglobin and haematocrit were observed in males at 1500 ppm Cadmium telluride. In females at 1500 ppm Cadmium telluride, only red blood cell distribution width was decreased. Given the slight degree of these variations and as they were mostly within historical control range, these were considered to be not adverse. Clinical chemistry findings were a decrease in total bilirubin and triglyceride levels in females at 1500 ppm Cadmium telluride. As these changes were relatively slight and remained within the historical control range, these findings were considered to be not adverse. At 30 ppm Cadmium chloride, alopecia was observed in females, which is likely to be test item-related. No changes in body weights and haematology parameters were observed. Clinical chemistry findings included a decrease in total bilirubin and triglyceride levels in females at 30 ppm Cadmium chloride, which remained within the historical control range and was therefore considered to be not adverse. One male showed increases in alanine aminotransferase (ALAT) and aspartate aminotransferase (ASAT) activities and urea, creatinine and glucose levels and decreases in total protein, albumin, (HDL and LDL) cholesterol and calcium levels. Furthermore, thyroid-stimulating hormone (TSH) and triiodothyronine (T3) levels were also decreased in this animal. In one male and one female also an increase in TSH levels were observed. At the severity affected, but in absence of histopathology, these findings were considered to be not adverse. At necropsy, a foci in the stomach was seen in one male in Week 4 and one male at the end of treatment. In absence of any related changes in food consumption and body weight, this isolated finding was considered to be not adverse. No test item-related changes were noted in any of the remaining parameters investigated in this study (i.e. food consumption, coagulation and organ weights). In conclusion, administration of Cadmium telluride by dietary administration for at least 90 days was well tolerated in rats at levels up to 1500 ppm (corresponding to a mean test article intake of 103 and 121 mg/kg body weight in males and females, respectively). Only slight non-adverse changes in haematology and clinical chemistry parameters were seen. The findings observed in animals treated with 30 ppm Cadmium chloride were limited to alopecia and changes in several clinical chemistry parameters.   The results of this study have demonstrated a significant difference in bioavailability potential between a relatively soluble cadmium compound, Cadmium chloride (the reference substance) and a relatively insoluble cadmium compound, cadmium telluride (test substance). Cadmium telluride exhibited no evidence of bioavailability by dietary administration for 90 days at high dose levels of 750 and 1500 ppm. No detectable and/or reliable levels of either cadmium or tellurium were detected in the target organs (liver and kidney), plasma and urine. In contrast, in the Cadmium chloride group, at a much lower dose level of (30 ppm), the Cadmium levels increased in the kidney and liver in line with the Loeser and Lorke study (1977). The results of this 90-day Toxicokinetic study were published by Poland et al. 2021 ‘Bioaccessibility as a Determining Factor in the Bioavailability and Toxicokinetics of Cadmium Compounds’ (https://doi.org/10.10.1016/j.tox.2021.152969). Repeated dose toxicity, dermal:   No animal studies were located regarding long term effects after dermal exposure to cadmium telluride. However, repeated dose toxicity via the dermal route is not expected to be significant as uptake of less-soluble cadmium compounds applied onto the skin of animals appears to be low (<1%) (see Toxicokinetics-absorption).   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/535f0d85-d37d-4d1b-90cf-5bd738801b33/documents/8ddf6555-f422-4bd5-9415-46b32d379b98_c2afdc4d-95de-45b6-b60a-aeeca973fadf.html,,,,,, Cadmium telluride,1306-25-8," Assessment of the acute oral toxicity of cadmium telluride in Nagy, Labresearch Ltd et al., 2008: A limit study with Wistar CRL:(WI) BR rats was carried out according to OECD guideline no 423 to assess the oral LD50. No deaths and no abnormalities in clinical signs, body weights, and necropsy findings were observed for any of the animals. An LD50 value >2000mg/kg bw was reported. Assessment of the acute inhalation toxicity of cadmium telluride in Nagy, Labresearch Ltd et al., 2008: A study was carried out according to OECD guideline no 403 to assess the acute inhalation toxicity of CdTe when administered to rats for a single continuous 4 -hour period, followed by an observation period of 14 days. The acute inhalation median lethal concentrations (4hr LC50) (and 95% confidence limits) of CdTe, in Wistar Crl:(WI) BR strain rats, were calculated to be: All animals: 2.71 mg/L; Male only: 2.53 mg/L; Female only: 2.87 mg/L ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/535f0d85-d37d-4d1b-90cf-5bd738801b33/documents/IUC5-b63ff89d-a311-484f-8a5c-5f23d566b1dd_c2afdc4d-95de-45b6-b60a-aeeca973fadf.html,,,,,, Cadmium telluride,1306-25-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/535f0d85-d37d-4d1b-90cf-5bd738801b33/documents/IUC5-b63ff89d-a311-484f-8a5c-5f23d566b1dd_c2afdc4d-95de-45b6-b60a-aeeca973fadf.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Caesium carbonate,534-17-8,"Based on the available 90 d studies with the structural analogues cesium hydroxide hydrate and cesium chloride NOAELs of 19.8 mg Cs/kg bw/d and 10.3 mg Cs/kg bw/d were determined, respectively. No effects were observed up to 19.8 mg Cs+/kg bw/d therefore the oral 90-day NOAEL of 25 mg CsOH*H2O/kg bw/d is used as source value. Re-calculation results in a NOAEL of 24.3 mg/kg bw/d for cesium carbonate which will be used as key value for risk assessment. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Read across from GLP and guideline compliant studies ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e7d11ad-4045-49e1-8827-055c6d87810c/documents/e5279045-fdcc-4d36-9f39-a195901ac727_39db50c8-029b-4710-87dc-cd3528863d92.html,,,,,, Caesium carbonate,534-17-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e7d11ad-4045-49e1-8827-055c6d87810c/documents/e5279045-fdcc-4d36-9f39-a195901ac727_39db50c8-029b-4710-87dc-cd3528863d92.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,24.3 mg/kg bw/day,,rat Caesium carbonate,534-17-8,"Cs2CO3 is not acutely toxic via the oral route as an LD50 was determined to be above 2000 mg/kg bw based on WoE assessment including the source substance CsCl. An LD50 of 2333 mg/kg bw with the target substance is used as key value. Cs2CO3 is not acutely toxic via the dermal route as LD50 dermal > 2000 mg/kg bw based on WoE assessment of read-across and target substance data. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Three literature values are used in a weight of evidence approach. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e7d11ad-4045-49e1-8827-055c6d87810c/documents/IUC5-70327129-0712-4c4c-9ec0-b49122940ff3_39db50c8-029b-4710-87dc-cd3528863d92.html,,,,,, Caesium carbonate,534-17-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e7d11ad-4045-49e1-8827-055c6d87810c/documents/IUC5-70327129-0712-4c4c-9ec0-b49122940ff3_39db50c8-029b-4710-87dc-cd3528863d92.html,,oral,LD50,"2,333 mg/kg bw",no adverse effect observed, Caesium carbonate,534-17-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e7d11ad-4045-49e1-8827-055c6d87810c/documents/IUC5-70327129-0712-4c4c-9ec0-b49122940ff3_39db50c8-029b-4710-87dc-cd3528863d92.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Caesium chloride,7647-17-8,"ORAL EXPOSURE:There is no subchronic toxicity study for cesium chloride available. Consequently, data from the structural analogous substance cesium hydroxide monohydrate were used. Based on the results of a 90-day study according to OECD guideline 408 the NOAEL for cesium hydroxide monohydrate was determined to be 25 mg/kg bw/day for male and female animals.The calculated NOAEL for cesium chloride is 25.1 mg/kg bw/day in male and female animals. In addition, a 28-day study according to OECD guideline 407 with cesium chloride is available. The oral NOAEL was determined to be 40 mg/kg bw/day in male and female rats.RESPIRATORY EXPOSURE:According to REACH Regulation (EC) No 1907/2006, Annex IX the test repeated dose toxicity after inhalation does not need to be conducted as repeated dose toxicity studies for oral application are available. In addition, due to the particle size distribution of the substance (d10: 188 µm, d50: 344 µm, d90: 556 µm) no inhalable particles are expected. Inhalation exposure is thus expected to be negligible.DERMAL EXPOSURE:According to column 2 of REACH Regulation (EC) No 1907/2006, Annex VIII, IIX, Section 8.6.1, the test repeated dose toxicity after dermal application does not need to be conducted as repeated dose toxicity studies for oral application are available. Moreover, based on its physico-chemical properties and absence of toxicity in acute dermal toxicity studies very limited absorption into the systemic circulation is expected after dermal application. Literature data support this estimation (see IUCLID section 7.1 ""Basic toxicokinetics""). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/709aa225-0c13-4c5b-a34a-236efaf2fecc/documents/IUC5-8d31ce7c-a77c-45cc-bff4-a51409070b88_6a80b7a9-dfc5-4b8d-901b-cde94d6c4540.html,,,,,, Caesium chloride,7647-17-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/709aa225-0c13-4c5b-a34a-236efaf2fecc/documents/IUC5-8d31ce7c-a77c-45cc-bff4-a51409070b88_6a80b7a9-dfc5-4b8d-901b-cde94d6c4540.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25.1 mg/kg bw/day,,rat Caesium chloride,7647-17-8,According to the results of an acute oral toxicity study with cesium chloride and acute dermal toxicity studies with two structural analogous read-across substances cesium chloride is not classified according to Regulation (EC) No 1272/2008 (CLP/GHS). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/709aa225-0c13-4c5b-a34a-236efaf2fecc/documents/IUC5-b1a6f213-e04b-469d-8ba8-984df56dc000_6a80b7a9-dfc5-4b8d-901b-cde94d6c4540.html,,,,,, Caesium chloride,7647-17-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/709aa225-0c13-4c5b-a34a-236efaf2fecc/documents/IUC5-b1a6f213-e04b-469d-8ba8-984df56dc000_6a80b7a9-dfc5-4b8d-901b-cde94d6c4540.html,,oral,LD50,"2,600 mg/kg bw",no adverse effect observed, Caesium fluoride,13400-13-0,"Based on the two 90 d studies with the structural analogues cesium hydroxide hydrate and cesium chloride as well as a 2 year study with sodium fluoride the following effects levels were determined: NOAEL (CsOH): 25 mg/kg bw/day for male and female animals (equivalent to 19.8 mg Cs/kg bw/day) NOAEL (CsCL): 13 mg CsCl/kg bw/day (equivalent to 10 mg Cs/kg bw/day) LOAEL (NaF): 3.75 mg/kg bw/d (equivalent to 1.7 mg F/kg bw/d) No effects were observed up to 19.8 mg Cs+/kg bw/d. The lowest observed adverse effect level was 1.7 mg F/kg bw/d. Re-calculation results in a NOAEL of 22.6 mg/kg bw/d and a LOAEL of 13.9 mg/kg bw/d for cesium fluoride. The LOAEL derived from sodium fluoride will be taken as key value for risk assessment. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): WoE of read-across from GLP and guideline compliant studies ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1968cad9-0aaa-49c8-b799-7edf1d36f999/documents/9ca60665-5877-4723-9b8e-97e8ba471eea_4cb1d728-754e-4bab-85e1-b487f76fee63.html,,,,,, Caesium fluoride,13400-13-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1968cad9-0aaa-49c8-b799-7edf1d36f999/documents/9ca60665-5877-4723-9b8e-97e8ba471eea_4cb1d728-754e-4bab-85e1-b487f76fee63.html,Chronic toxicity – systemic effects,oral,LOAEL,13.9 mg/kg bw/day,,rat Caesium fluoride,13400-13-0,"CsF is acutely toxic via the oral route as LD50 oral was determined to be 300 mg/kg bw> LD50 < 2000 mg/kg bw.CsF is not acutely toxic via the dermal route as LD50 dermal > 2000 mg/kg bw based on WoE assessment of read-across data. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): One key study conducted according GLP and rated as KL1 is available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): read-across to GLP and guideline compliant study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1968cad9-0aaa-49c8-b799-7edf1d36f999/documents/481468d6-c3c1-4103-b9d5-5f2c5974d027_4cb1d728-754e-4bab-85e1-b487f76fee63.html,,,,,, Caesium fluoride,13400-13-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1968cad9-0aaa-49c8-b799-7edf1d36f999/documents/481468d6-c3c1-4103-b9d5-5f2c5974d027_4cb1d728-754e-4bab-85e1-b487f76fee63.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Caesium fluoride,13400-13-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1968cad9-0aaa-49c8-b799-7edf1d36f999/documents/481468d6-c3c1-4103-b9d5-5f2c5974d027_4cb1d728-754e-4bab-85e1-b487f76fee63.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Caesium hydroxide,21351-79-1,"A NOAEL for subchronic oral gavage toxicity of 25 mg/kg bw/day was derived from a 90 day toxicity study in rats exposed to the test item cesium hydroxide monohydrate (OECD408, EU method B.26 and EPA guideline OPPTS 870.3100 ). Based on these results the calculated NOAEL for cesium hydroxide anhydrous is 22.32 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/327a0b5e-4b79-447c-be5c-cb45ca8dafcf/documents/IUC5-71c75bee-2ca5-4546-aa6e-3b66396889f6_79980671-5403-4575-8684-42a1d88303f8.html,,,,,, Caesium hydroxide,21351-79-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/327a0b5e-4b79-447c-be5c-cb45ca8dafcf/documents/IUC5-71c75bee-2ca5-4546-aa6e-3b66396889f6_79980671-5403-4575-8684-42a1d88303f8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,22.32 mg/kg bw/day,,rat Caesium hydroxide,21351-79-1,The acute oral LD50 of cesium hydroxide in albino rats was determined to be 1026 mg/kg bw. Acute inhalation and dermal toxicity was waived as cesium hydroxide monohydrate and cesium hydroxide anhydrous are corrosive to the skin. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/327a0b5e-4b79-447c-be5c-cb45ca8dafcf/documents/IUC5-e5078d95-626e-473e-b254-6cac9b543ff8_79980671-5403-4575-8684-42a1d88303f8.html,,,,,, Caesium hydroxide,21351-79-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/327a0b5e-4b79-447c-be5c-cb45ca8dafcf/documents/IUC5-e5078d95-626e-473e-b254-6cac9b543ff8_79980671-5403-4575-8684-42a1d88303f8.html,,oral,LD50,"1,026 mg/kg bw",adverse effect observed, Caesium iodide,7789-17-5,"ORAL EXPOSURE:There is no repeated dose toxicity study for cesium iodide available. Consequently, data from the structural analogous substance cesium hydroxide monohydrate were used. Based on the results of a 90-day study according to OECD guideline 408 the NOAEL for cesium hydroxide monohydrate was determined to be 25 mg/kg bw/day for male and female animals.The calculated NOAEL for cesium iodide is 38.7 mg/kg bw/day in male and female animals. In addition a 28-day study according to OECD guideline 408 with cesium iodide and a related 14-day dose range finding study were performed. For reasons of precautions a NOEL and a NOAEL of 100 mg /kg bw/day were therefore deduced from this study with cesium iodide for male and female animals.RESPIRATORY EXPOSURE:In accordance with column 2 of REACH Regulation EC (No) 1907/2006 Annex IX, the test repeated dose toxicity after inhalation (section 8.6) does not need to be conducted as a repeated dose toxicity study for oral application is available. In addition exposure via the inhalation route is not likely as the vapour pressure of cesium iodide is expected to be very low (< 0.1 hPa at 20°C) and the particle size distribution shows no inhalable particles (d10 = 125 µm). In conclusion, no further testing with regard to repeated inhalation toxicity is needed.DERMAL EXPOSURE:In accordance with column 2 of REACH Regulation EC (No) 1907/2006 Annex IX, the test repeated dose toxicity after dermal application (section 8.6) does not need to be conducted as repeated dose toxicity studies for oral application are available. Moreover, based on its physico-chemical properties and absence of toxicity in an acute dermal toxicity study very limited absorption into the systemic circulation is expected after dermal application. Literature data support this estimation (see section 7.1 Basic toxicokinetics). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc36acac-df84-435a-954f-59697282c715/documents/IUC5-2149e4b4-c7de-44d4-8b59-683de4117cd5_c74b0b3e-b8e3-48ca-8bb5-9fd1463dcbbb.html,,,,,, Caesium iodide,7789-17-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc36acac-df84-435a-954f-59697282c715/documents/IUC5-2149e4b4-c7de-44d4-8b59-683de4117cd5_c74b0b3e-b8e3-48ca-8bb5-9fd1463dcbbb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,38.7 mg/kg bw/day,,rat Caesium iodide,7789-17-5,"The acute oral LD50 value and the acute dermal LD50 value of the test item was greater than 2000 mg/kg bw in rats. Therefore, the test item has not to be classified according to Regulation (EC) No 1272/2008 (CLP/GHS).According to REACH Regulation (EC) No 1907/2006, Annex VIII, 8.5 data for a maximum of two routes of exposure need to be provided. Testing for acute toxicity via the inhalation route was not applicable as data on acute oral and acute dermal toxicity were available. Based on the results of the particle size distribution study (d10: 125 µm, d50: 226 µm, d90: 391 µm) no inhalable particles are expected. Inhalation exposure is thus expected to be negligible. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc36acac-df84-435a-954f-59697282c715/documents/IUC5-7fc68ba2-bdcf-42e5-a8c5-41f3bc537b58_c74b0b3e-b8e3-48ca-8bb5-9fd1463dcbbb.html,,,,,, Caesium iodide,7789-17-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc36acac-df84-435a-954f-59697282c715/documents/IUC5-7fc68ba2-bdcf-42e5-a8c5-41f3bc537b58_c74b0b3e-b8e3-48ca-8bb5-9fd1463dcbbb.html,,oral,LD50,"2,386 mg/kg bw",adverse effect observed, Caesium iodide,7789-17-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc36acac-df84-435a-954f-59697282c715/documents/IUC5-7fc68ba2-bdcf-42e5-a8c5-41f3bc537b58_c74b0b3e-b8e3-48ca-8bb5-9fd1463dcbbb.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Caesium nitrate,7789-18-6,"90-day repeated dose toxicity with cesium hydroxide:A subchronic repeated dose toxicity test with cesium nitrate is not available. Consequently, read-across was applied using study results from cesium hydroxide monohydrate.The No Observed Adverse Effect Level (NOAEL) for cesium hydroxide monohydrate was determined to be 25 mg/kg bw/day for male and female animals.Based on these observations the NOAEL for cesium and cesium nitrate were calculated as follows: NOAEL cesium: 19.8 mg/kg bw/day for male and female animals.NOAEL cesium nitrate: 29.02 mg/kg bw/day for male and female animals.28-day repeated dose toxicity with cesium hydroxide monohydrate and cesium iodide:A subacute repeated dose toxicity test with cesium nitrate is not available. Consequently, read-across was applied using study results from cesium hydroxide monohydrate.The No Observed Adverse Effect Level (NOAEL) for cesium hydroxide monohydrate was as follows: NOAEL cesium hydroxide monohydrate: 125 mg/kg bw/day for male and female animals Based on these observations the NOAEL for cesium and cesium nitrate derived from the cesium hydroxide monohydrate study were as follows: NOAEL cesium: 98.93 mg/kg bw/day for male and female animals.NOAEL cesium nitrate: 145.08 mg/kg bw/day for male and female animals.A 28-day repeated dose toxicity study with cesium iodide is also available supporting the general results of the study with cesium hydroxide monohydrate. However, as the effects seen are not only linked to cesium but are also contributed to the anion, the NOAEL for cesium nitrate was derived from the cesium hydroxide monohydrate values only. 14-day toxicity study with cesium hydroxide monohydrate:A read-across was applied using study results from a 14 -day toxicity study with cesium hydroxide monohydrate.Based on these observations the doses for a 28-day oral toxicity study (main study) with cesium hydroxide monohydrate were determined. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d2e1981-b41c-4ea0-a83c-ba323ba02907/documents/IUC5-9eb2638a-bb91-4fbf-b7f2-ed47ab499888_23cf5613-6c80-479e-bef7-f17963b46359.html,,,,,, Caesium nitrate,7789-18-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d2e1981-b41c-4ea0-a83c-ba323ba02907/documents/IUC5-9eb2638a-bb91-4fbf-b7f2-ed47ab499888_23cf5613-6c80-479e-bef7-f17963b46359.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,29.02 mg/kg bw/day,,rat Caesium nitrate,7789-18-6,"The acute oral LD50 obtained for the test item was found to be between 300 and 2000 mg/kg bw. Therefore, the test item is classified as category 4 according to Regulation (EC) No 1272/2008 (CLP/GHS).The acute dermal LD50 value of the test item was > 2000 mg/kg bw in male and female Crl:(WI)BRrats.According to REACH Regulation (EC) No 1907/2006, Annex VIII, Section 8.5, data for a maximum of two routes of exposure need to be provided. Testing for acute toxicity via the inhalation route was not applicable as data on acute oral and acute dermal toxicity were available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d2e1981-b41c-4ea0-a83c-ba323ba02907/documents/IUC5-f8064fb1-2606-4328-84c2-53cba6cb62ed_23cf5613-6c80-479e-bef7-f17963b46359.html,,,,,, Caesium nitrate,7789-18-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d2e1981-b41c-4ea0-a83c-ba323ba02907/documents/IUC5-f8064fb1-2606-4328-84c2-53cba6cb62ed_23cf5613-6c80-479e-bef7-f17963b46359.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Caesium nitrate,7789-18-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d2e1981-b41c-4ea0-a83c-ba323ba02907/documents/IUC5-f8064fb1-2606-4328-84c2-53cba6cb62ed_23cf5613-6c80-479e-bef7-f17963b46359.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Caesium sulphate,10294-54-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/267131dc-a8ab-44c5-a4a9-d9b97ae784e4/documents/fd90910d-7a31-4e7f-9331-bcea6db80273_871af666-b405-404f-b4f1-4ae043354597.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,13.93 mg/kg bw/day,,rat Caesium sulphate,10294-54-9,"According to the results from the acute oral toxicity study, the LD50 obtained for the test item was found to be between 300 and 2000 mg/kg bw. Therefore, the test item is classified as harmful if swallowed (category 4) according to Regulation (EC) No 1272/2008 (CLP/GHS).According to the results of acute dermal toxicity studies with two structural analogous read-across substances the test item is not classified according to Regulation (EC) No 1272/2008 (CLP/GHS) or Directive 67/548/EEC (DSD).   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/267131dc-a8ab-44c5-a4a9-d9b97ae784e4/documents/43aadf10-3065-449e-ab46-1bf2ede9efe3_871af666-b405-404f-b4f1-4ae043354597.html,,,,,, Caesium sulphate,10294-54-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/267131dc-a8ab-44c5-a4a9-d9b97ae784e4/documents/43aadf10-3065-449e-ab46-1bf2ede9efe3_871af666-b405-404f-b4f1-4ae043354597.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "Calcines, zinc ore-conc.",69012-79-9,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a5bdbf89-a189-4f74-a4d1-bd7ea83beb1c/documents/9c768120-8fde-46bc-98d6-2b03a8c3bebc_e961606b-3358-4452-92e4-1153ec72dcfe.html,,,,,, "Calcines, zinc ore-conc.",69012-79-9,The acute toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5bdbf89-a189-4f74-a4d1-bd7ea83beb1c/documents/80c8cf03-2d5e-4923-a427-8e300f9ba7a0_e961606b-3358-4452-92e4-1153ec72dcfe.html,,,,,, Calcium,7440-70-2,"Metallic calcium used in industrial processes exhibits only risk through inhalation and dermal exposure when emitted from the process as oxidated and subsequently hydroxylated form, which will release hydroxyl ions as first contact effects. This first contact effect will have alkali effects as the main irritant effect which prolonged may cause severe local alterations, including inflammation, metaplasia and hyperplasia which can ultimately lead to chronic inflammation and increased risk of development of cancer. Long-term exposure of low levels of CaO-Ca(OH)2 dust particles are expected to cause sensory irritation and decrease of the lung function parameters. Sensory irritation is the primary effect and may be prevented by STEL-level of 1 mg/m3 of respirable dust as demonstrated by an acute inhalation toxicity study (See section 7.10 of IUCLIC, Cain et al (2004)), 8h-TWA OEL was recommended to set at 4 mg/m3. Prevention of first contact to external surfaces by appropriate risk management measures will minimize the risk of these long-term effects effectively (see chapter 9 of CSR). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c937cf3d-133a-4fb1-a97e-d1153ccf70f6/documents/5e519124-a2a1-46a7-9f6a-166a0ec63f02_fddcd798-ce73-446a-b947-ffc89a745e91.html,,,,,, Calcium,7440-70-2,"As testing of elemental calcium is not technically feasible because of its reactivity in air or water, acute toxicity was evaluated based on (1) the exposure considerations in its use industrial applications as well as based on (2) the read-across data from relevant calcium compounds. Based on the Ca use in metallurgical use applications, a) acute oral toxicity was not considered to be relevant exposure route when assessing the human health hazard. b) acute dermal toxicity of elemental calcium in its industrial use applications, exposure potential is negligible and qualitative assessment of risk indicates that the risk is low, particularly as a result of the use of existing risk management measures in place (see chapter 9 and 10 in CSR). c) With respect to Ca use in its industrial applications, it appears that there is the possibility for inhalation exposure of the workers to Ca from the dust or fume. Therefore, inhalation was considered as relevant exposure route for acute toxicity, and the quantitative exposure assessment was considered necessary (see chapter 9 in CSR). However, the RCR with existing RMMs indicated low level of concern (see chapter 9 and 10 in CSR). Testing of elemental Ca is not technically feasible because Ca metal reacts with water, evolving hydrogen gas. In powdered form the reaction with water is extremely rapid. In the Ca-water reaction calcium dihydroxide (Ca(OH) 2) is formed. Therefore, the acute toxicity was evaluated based on surrogate data from calcium dihydroxide (Ca(OH) 2). The subsequent reaction with air (calcium oxide) and moisture results in calcium hydroxide which is considered non-hazardous for human regarding acute toxicity, only exerting local irritative effects upon first contact on external surfaces of the human body. Upon this first contact exothermal reaction causes hydroxyl ion to liberate affecting skin and mucous membranes. Accidental exposure may cause desiccation of these tissues. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c937cf3d-133a-4fb1-a97e-d1153ccf70f6/documents/fb732137-7ce5-41a5-b3c7-cda890c8df5b_fddcd798-ce73-446a-b947-ffc89a745e91.html,,,,,, Calcium (S)-2-hydroxypropionate,28305-25-1," There are no reliable studies available for the assessment of the repeated dose toxicity endpoint with the target substance Calcium (S)-lactate itself, but available data from an oral repeated dose toxicity study conducted with the pentahydrate of calcium lactate was used to assess the specific target organ toxicity of the target substance. Based on the results, no classification for specific target organ toxicity is warranted for Calcium (S)-lactate. For details and justification of read-across please refer to the report attached in section 13 of IUCLID. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4e58e3e-463c-49d9-bc63-bd01143d0726/documents/IUC5-5763feb1-8930-43d4-9655-8f3532a87b6d_5c1f3618-826a-4a1d-bd34-a0fde9a97c7e.html,,,,,, Calcium (S)-2-hydroxypropionate,28305-25-1," By way of read-across from lactic acid (constituting the toxicologically relevant moiety) and calcium chloride, Calcium (S)-lactate is evaluated to be acutely non-toxic via any of the standard routes of administration (oral, inhalation, dermal). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4e58e3e-463c-49d9-bc63-bd01143d0726/documents/IUC5-c6863598-31e0-4592-84cd-a0e89e67e428_5c1f3618-826a-4a1d-bd34-a0fde9a97c7e.html,,,,,, Calcium (S)-2-hydroxypropionate,28305-25-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4e58e3e-463c-49d9-bc63-bd01143d0726/documents/IUC5-c6863598-31e0-4592-84cd-a0e89e67e428_5c1f3618-826a-4a1d-bd34-a0fde9a97c7e.html,,oral,LD50,"3,543 mg/kg bw",adverse effect observed, Calcium (S)-2-hydroxypropionate,28305-25-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4e58e3e-463c-49d9-bc63-bd01143d0726/documents/IUC5-c6863598-31e0-4592-84cd-a0e89e67e428_5c1f3618-826a-4a1d-bd34-a0fde9a97c7e.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Calcium (S)-2-hydroxypropionate,28305-25-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4e58e3e-463c-49d9-bc63-bd01143d0726/documents/IUC5-c6863598-31e0-4592-84cd-a0e89e67e428_5c1f3618-826a-4a1d-bd34-a0fde9a97c7e.html,,inhalation,LC50,"> 7,940 mg/m3",adverse effect observed, "Calcium 1,4-bis(2-ethylhexyl) bis(2-sulphosuccinate)",128-49-4," No data are available for the registered substance, however data are available for the corresponding sodium salt of the substance, docusate sodium (CAS 577-11-7). These data are used for read-across to the registered substance calcium docusate (CAS 128 -49 -4). The presence of either of the counterions sodium or calcium is not considered to have an impact on the toxicity. It is therefore considered justified to use the data of the sodium salt for read across to the calcium salt of docusate. Repeated dose toxicity was tested in various species, including rats, dogs, rabbits and monkeys.  The NOAEL of 750 mg/kg bw/day obtained in the key study in rats was confirmed to be consistent with  data from docusate sodium and category members in supporting studies in rats; other data from other species were of limited reliability and relevance and therefore not taken into account. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2049d6a7-d0f8-410a-85a6-4ea0c53e7c26/documents/db21d346-260e-4bb3-92cb-197f39de22e9_67a42911-0ba0-42f8-9c5b-a68f64121773.html,,,,,, "Calcium 1,4-bis(2-ethylhexyl) bis(2-sulphosuccinate)",128-49-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2049d6a7-d0f8-410a-85a6-4ea0c53e7c26/documents/db21d346-260e-4bb3-92cb-197f39de22e9_67a42911-0ba0-42f8-9c5b-a68f64121773.html,Chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Calcium 1,4-bis(2-ethylhexyl) bis(2-sulphosuccinate)",128-49-4," No data are available for the registered substance, however data are available for the corresponding sodium salt of the substance, docusate sodium (CAS 577-11-7). These data are used for read-across to the registered substance calcium docusate (CAS 128 -49 -4). The presence of either of the counterions sodium or calcium is not considered to have an impact on the toxicity. It is therefore considered justified to use the data of the sodium salt for read across to the calcium salt of docusate. Both oral and dermal acute toxicity were tested in various studies with docusate sodium and formulations, demonstrating that LD50 values were above the limit dose of 2000 mg active ingredient/kg bw. LD50 values are  approximately 3000 mg/kg bw for acute oral toxicity in rats and 2525 mg/kg bw for acute dermal toxicity in rabbits. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2049d6a7-d0f8-410a-85a6-4ea0c53e7c26/documents/d337f8b8-8d5f-4129-961b-09de05212d6d_67a42911-0ba0-42f8-9c5b-a68f64121773.html,,,,,, "Calcium 1,4-bis(2-ethylhexyl) bis(2-sulphosuccinate)",128-49-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2049d6a7-d0f8-410a-85a6-4ea0c53e7c26/documents/d337f8b8-8d5f-4129-961b-09de05212d6d_67a42911-0ba0-42f8-9c5b-a68f64121773.html,,oral,LD50,"3,000 mg/kg bw",, "Calcium 1,4-bis(2-ethylhexyl) bis(2-sulphosuccinate)",128-49-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2049d6a7-d0f8-410a-85a6-4ea0c53e7c26/documents/d337f8b8-8d5f-4129-961b-09de05212d6d_67a42911-0ba0-42f8-9c5b-a68f64121773.html,,dermal,LD50,"2,525 mg/kg bw",, "Calcium 1,4-bis(2-ethylhexyl) bis(2-sulphosuccinate)",128-49-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2049d6a7-d0f8-410a-85a6-4ea0c53e7c26/documents/d337f8b8-8d5f-4129-961b-09de05212d6d_67a42911-0ba0-42f8-9c5b-a68f64121773.html,,inhalation,LC50,"20,000 mg/m3",, "Calcium 3,5,5-trimethylhexanoate",64216-15-5,"No repeated dose toxicity study with calcium 3,5,5-trimethylhexanoate is available, thus the repeated dose toxicity will be addressed with existing data on the individual dissociation products calcium and 3,5,5-trimethylhexanoic acid. In relevant and reliable repeated dose toxicity studies for both dissociation products of calcium 3,5,5-trimethylhexanoate, there were no toxicological findings reported that would justify a classification. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83c33faa-d24f-48b6-93d2-de7f3b579d8d/documents/IUC5-c9e30f68-dbde-430f-98e8-9987e3361184_a88d1886-40d3-4597-b6dc-9622184b6301.html,,,,,, "Calcium 3,5,5-trimethylhexanoate",64216-15-5,"In a GLP conform OECD 423 study, the acute oral LD50 value of the test item Calcium bis(2-ethylhexanoate) was found to be > 2000 mg/kg bw in female Han:WIST rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83c33faa-d24f-48b6-93d2-de7f3b579d8d/documents/IUC5-a877a8ab-61e6-4d99-967d-a08d1ea25a2d_a88d1886-40d3-4597-b6dc-9622184b6301.html,,,,,, "Calcium 3,5,5-trimethylhexanoate",64216-15-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83c33faa-d24f-48b6-93d2-de7f3b579d8d/documents/IUC5-a877a8ab-61e6-4d99-967d-a08d1ea25a2d_a88d1886-40d3-4597-b6dc-9622184b6301.html,,oral,LD50,"> 2,000 mg/kg bw",adverse effect observed, "Calcium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate",65212-77-3," The test item was not tested for repeated dose toxicity. It is acceptable to derive the systemic toxicity from experimental data of a structural analogue (di-sodium salt) since both are salts with comparable structures. In addition, lower solubility and the higher molecular weight of the test item give a safety margin. A subacute toxicity study on rats (OECD 407, GLP) was performed to evaluate the repeated dose toxicity of the substance. The test item did not induce any mortalities, abnormalities or clinical symptoms. Based on the results of these studies, the NOEL and the NOAEL of the test substance is 1462.9 and 1552.1 mg/kg bw /d for male and female rats, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d089911f-6315-45d4-b2ae-ad1f0f6ffe12/documents/IUC5-6e64b21a-e943-4222-b301-5e53983c3d64_7d3c26a2-000f-4c52-a6a4-1835d33b9cf0.html,,,,,, "Calcium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate",65212-77-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d089911f-6315-45d4-b2ae-ad1f0f6ffe12/documents/IUC5-6e64b21a-e943-4222-b301-5e53983c3d64_7d3c26a2-000f-4c52-a6a4-1835d33b9cf0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,462.9 mg/kg bw/day",,rat "Calcium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate",65212-77-3," Three studies were performed to evaluate acute oral, dermal and inhalative toxicity of the test substance to the rat (according OECD 401, 402, 403). Neither the test substance nor structural analogues induce mortalities, abnormalities or clinical signs when applied oral or dermal. Also single administration via respiratory system did not cause health effects or mortalities. The LD50 for oral and dermal toxicity is considered to be > 2000 mg/kg bw, LC50 is > 5.5 mg/l air. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d089911f-6315-45d4-b2ae-ad1f0f6ffe12/documents/IUC5-9a4d11ff-0f9a-43e7-b038-055bc8642c46_7d3c26a2-000f-4c52-a6a4-1835d33b9cf0.html,,,,,, "Calcium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate",65212-77-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d089911f-6315-45d4-b2ae-ad1f0f6ffe12/documents/IUC5-9a4d11ff-0f9a-43e7-b038-055bc8642c46_7d3c26a2-000f-4c52-a6a4-1835d33b9cf0.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Calcium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate",65212-77-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d089911f-6315-45d4-b2ae-ad1f0f6ffe12/documents/IUC5-9a4d11ff-0f9a-43e7-b038-055bc8642c46_7d3c26a2-000f-4c52-a6a4-1835d33b9cf0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Calcium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate",65212-77-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d089911f-6315-45d4-b2ae-ad1f0f6ffe12/documents/IUC5-9a4d11ff-0f9a-43e7-b038-055bc8642c46_7d3c26a2-000f-4c52-a6a4-1835d33b9cf0.html,,inhalation,LC50,5.5 mg/m3,no adverse effect observed, Calcium 4-[(4-chloro-3-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate,7538-59-2," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a16fcb0-5984-4a7e-ab62-88c654b76190/documents/f2547c9d-e31f-4754-8efe-f11dd04de039_60ee1350-33d6-4770-ae39-4893bb0df60c.html,,,,,, Calcium 4-[(4-chloro-3-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate,7538-59-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a16fcb0-5984-4a7e-ab62-88c654b76190/documents/f2547c9d-e31f-4754-8efe-f11dd04de039_60ee1350-33d6-4770-ae39-4893bb0df60c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Calcium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate,7023-61-2," The NOAEL for chronic oral toxicity is established at 25 mg/kg bw based on repeated dose toxicity studies with analogue substances. Higher doses result in kidney damage. This is derived from subacute gavage studies with Pigment Red 57:1(Ca) (OECD 422, GLP, MHLW 1993). No histopathology findings on kidneys were reported after a two-year skin painting study with mice with Pigment Red 57:1(Ca) (Carson 1984). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4971e23-7027-48ea-b176-b6013e4b8164/documents/IUC5-3213757a-b26b-41fa-a216-9228de5350e6_7647e8b3-e938-4035-8e10-da0e0a0f31bc.html,,,,,, Calcium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate,7023-61-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4971e23-7027-48ea-b176-b6013e4b8164/documents/IUC5-3213757a-b26b-41fa-a216-9228de5350e6_7647e8b3-e938-4035-8e10-da0e0a0f31bc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Calcium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate,7023-61-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4971e23-7027-48ea-b176-b6013e4b8164/documents/IUC5-3213757a-b26b-41fa-a216-9228de5350e6_7647e8b3-e938-4035-8e10-da0e0a0f31bc.html,Chronic toxicity – systemic effects,dermal,NOAEL,50 mg/kg bw/day,,mouse Calcium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate,7023-61-2," Studies of Pigment Red 48:2 and of other members of the same category indicate that Pigment Red 48:2 is not acutely toxic via the oral, inhalation, and dermal route of exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4971e23-7027-48ea-b176-b6013e4b8164/documents/IUC5-bf6d22ed-70ea-4f5c-99e3-1693359af29f_7647e8b3-e938-4035-8e10-da0e0a0f31bc.html,,,,,, Calcium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate,7023-61-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4971e23-7027-48ea-b176-b6013e4b8164/documents/IUC5-bf6d22ed-70ea-4f5c-99e3-1693359af29f_7647e8b3-e938-4035-8e10-da0e0a0f31bc.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Calcium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate,7023-61-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4971e23-7027-48ea-b176-b6013e4b8164/documents/IUC5-bf6d22ed-70ea-4f5c-99e3-1693359af29f_7647e8b3-e938-4035-8e10-da0e0a0f31bc.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, Calcium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate,7023-61-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4971e23-7027-48ea-b176-b6013e4b8164/documents/IUC5-bf6d22ed-70ea-4f5c-99e3-1693359af29f_7647e8b3-e938-4035-8e10-da0e0a0f31bc.html,,inhalation,LC50,"1,518 mg/m3",no adverse effect observed, Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate,129423-54-7," Repeated oral toxicity:An OECD test guideline (OECD 407) and GLP-compliant Combined Repeated Dose Toxicity Study was performed with the test item (Pigment Yellow 191). Groups of 5 male and 5 female Wistar rats received doses of 0, 62.5, 250 and 1000 mg/kg bw by daily gavage for 28 days . No toxicologically significant changes were noted in any of the parameters investigated in this study (such as clinical signs, neurological examinations, body weight, food consumption, macroscopic examination, organ weights, or microscopic examination). Only minor effects were observed in the clinical laboratory investigations and a decreased specific urine weight was determined in both sexes of the high dose group. A No Observed Adverse Effect Level (NOAEL) for the test item of 1000 mg/kg/day was established.Repeated dermal toxicity:The dermal route was waived. The substance is considered not to exert adverse effects.Repeated inhalation toxicity:The inhalation route was waived. The substance is considered not to exert adverse effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79b90f19-c5c2-486e-9842-c7682e5965e6/documents/41b6cb72-15c6-49ea-b64d-128690fe3141_739c1dbe-5c9e-4f16-a255-b3a11212ecfd.html,,,,,, Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate,129423-54-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79b90f19-c5c2-486e-9842-c7682e5965e6/documents/41b6cb72-15c6-49ea-b64d-128690fe3141_739c1dbe-5c9e-4f16-a255-b3a11212ecfd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate,129423-54-7," Acute oral toxicity: The test item did not cause any mortality or clinical signs or necropsy findings after single oral gavage administration to male and female rats at 2000 mg/kg bw in a OECD guideline and GLP compliant study. The LD50 (male/female rat) was greater than 2000 mg/kg body weight. Acute dermal toxicity: The test item did not cause any mortality or clinical signs or necropsy findings after single dermal administration to male and female rats at 2000 mg/kg bw in a OECD guideline and GLP compliant study. Acute inhalation toxicity: Study was waived and classification for this endpoint is considered unwarranted. When aerosolized in respirable form, the substance is considered likely to behave like an inert dust. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79b90f19-c5c2-486e-9842-c7682e5965e6/documents/3d84b6a3-2784-4629-91d9-3f3868c3bc9b_739c1dbe-5c9e-4f16-a255-b3a11212ecfd.html,,,,,, Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate,129423-54-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79b90f19-c5c2-486e-9842-c7682e5965e6/documents/3d84b6a3-2784-4629-91d9-3f3868c3bc9b_739c1dbe-5c9e-4f16-a255-b3a11212ecfd.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Calcium 4-chloro-2-(5-hydroxy-3-methyl-1-(3-sulfonatophenyl)pyrazol-4-ylazo)-5-methylbenzenesulfonate,129423-54-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79b90f19-c5c2-486e-9842-c7682e5965e6/documents/3d84b6a3-2784-4629-91d9-3f3868c3bc9b_739c1dbe-5c9e-4f16-a255-b3a11212ecfd.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Calcium acetylide,75-20-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): no study available but no further data necessary Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): For Study see section 7.10.3 Respiratory irritation of calcium oxide/hydroxide has been assessed in several studies in volunteers and in occupational settings. The information is considered relevant for the risk assessment of calcium carbide. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): no study available but no further data necessary ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f89f7937-299c-46f0-95ed-f979b0738d70/documents/IUC5-1221d98f-7a39-406e-a807-82af29253ddd_78162245-e1e2-4446-9847-899e7c097999.html,,,,,, Calcium acetylide,75-20-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f89f7937-299c-46f0-95ed-f979b0738d70/documents/IUC5-1221d98f-7a39-406e-a807-82af29253ddd_78162245-e1e2-4446-9847-899e7c097999.html,Repeated dose toxicity – local effects,inhalation,LOAEC,5 mg/m3,adverse effect observed,other:human volunteers and workers Calcium bis(2-ethylhexanoate),136-51-6,"No repeated dose toxicity study with calcium bis(2-ethylhexanoate) is available, thus the repeated dose toxicity will be addressed with existing data on the individual dissociation products calcium and 2‑ethylhexanoic acid. In relevant and reliable repeated dose toxicity studies for both dissociation products of calcium bis(2-ethylhexanoate), there were no toxicological findings reported that would justify a classification. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6b8ae59-ad13-4e5d-9a47-2d491915b850/documents/IUC5-6233632d-1193-4bed-8bf3-349296561f01_1c1be407-69f8-4bf3-9bfc-1bf167640dc1.html,,,,,, Calcium bis(2-ethylhexanoate),136-51-6,"In a GLP conform OECD 423 study, the acute oral LD50 value of the test item Calcium bis(2-ethylhexanoate) was found to be 300 < LD50 ≤ 2000 mg/kg bw in female Han:WIST rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6b8ae59-ad13-4e5d-9a47-2d491915b850/documents/IUC5-a9ea850c-bc66-4ebd-b52b-ce37e2d0f33f_1c1be407-69f8-4bf3-9bfc-1bf167640dc1.html,,,,,, Calcium bis(2-ethylhexanoate),136-51-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6b8ae59-ad13-4e5d-9a47-2d491915b850/documents/IUC5-a9ea850c-bc66-4ebd-b52b-ce37e2d0f33f_1c1be407-69f8-4bf3-9bfc-1bf167640dc1.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, Calcium bis(metaphosphate),13477-39-9, There are currently no experimental data available to assess repeated dose toxicity for the test substance. A data waiver is set in place to justify that no further repeated dose toxicity testing is required. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58ec9e0e-1483-4494-a3bf-133d1697a3b8/documents/30925f0a-3650-4c59-b796-792414a00d97_db9a6e1e-7dba-4498-bdf7-b7df6abc9433.html,,,,,, Calcium bis(metaphosphate),13477-39-9," No studies are available for calcium bis(metaphosphate). Reliable data are available for the structural analogue dicalcium pyrophosphate (CAS 7790 -76 -3). Oral (RA 7790 -76 -3): LD50 > 2000 mg/kg bw (female rats, RL1, OECD 420) Inhalation (RA 7790 -76 -3): LC50 > 5.09 mg/L air (male and female rats, RL1, OECD436) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58ec9e0e-1483-4494-a3bf-133d1697a3b8/documents/c22ce8f6-3da5-4639-a288-ccad79572711_db9a6e1e-7dba-4498-bdf7-b7df6abc9433.html,,,,,, Calcium bis(metaphosphate),13477-39-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58ec9e0e-1483-4494-a3bf-133d1697a3b8/documents/c22ce8f6-3da5-4639-a288-ccad79572711_db9a6e1e-7dba-4498-bdf7-b7df6abc9433.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Calcium bis(metaphosphate),13477-39-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58ec9e0e-1483-4494-a3bf-133d1697a3b8/documents/c22ce8f6-3da5-4639-a288-ccad79572711_db9a6e1e-7dba-4498-bdf7-b7df6abc9433.html,,inhalation,discriminating conc.,"5,090 mg/m3",no adverse effect observed, Calcium bis[(Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate],16026-16-7," No data on acute toxicity by oral route is available for the substance calcium bis[(Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate]. Read across from its structural analogue, N-methyl-N-[C18-(unsaturated)alkanoyl]glycine, is used to complete this endpoint. The LD50 value for N-methyl-N-[C18-(unsaturated)alkanoyl]glycine is determined to be >5000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5703a8d3-d98f-4875-87b6-116947342fee/documents/8335cf9d-94d3-4e85-85bd-d80334ca50db_c9995c96-b009-4574-b75e-eb6e0e4998eb.html,,,,,, Calcium bis[(Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate],16026-16-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5703a8d3-d98f-4875-87b6-116947342fee/documents/8335cf9d-94d3-4e85-85bd-d80334ca50db_c9995c96-b009-4574-b75e-eb6e0e4998eb.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Calcium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate],1103-39-5,"Repeated dose toxicity of the test substance was not examined. Reliable experimental data of an analogue substance are available. Three studies are suitable to provide information on toxicity after repeated dose administration. The subacute toxicity study in rats at dose levels up to 5% (unknown purity) revealed formation of Heinzbodies, changes in hematology and pathological and histopathological changes in splenn and kidney. The 90d study at dose levels up to 10000 ppm which served as range finder for a cancer study confirms the findings of the 28d study. Additionally, congestion of the spleen and hemosiderosis in the liver was observed. A chronic study in mice at dose levels up to 1000 ppm revealed no adverse effects than changes in hematology. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/292e4fc5-c10c-48db-848c-c95272b0d4c5/documents/591b4ac7-3026-4906-af0b-c7ccc884d4e2_05c41673-7a56-411f-b0eb-4a35aae6cea2.html,,,,,, Calcium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate],1103-39-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/292e4fc5-c10c-48db-848c-c95272b0d4c5/documents/591b4ac7-3026-4906-af0b-c7ccc884d4e2_05c41673-7a56-411f-b0eb-4a35aae6cea2.html,Chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Calcium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate],1103-39-5,"Studies on acute toxicity of the test item were not performed. Since all substances are metal laked salts with comparable structure and similar solubility, information on acute toxicity were derived from experimental data of a structural analogue. Five studies were performed to evaluate acute oral and inhalative toxicity of the test substance to the rat (according OECD 401 and 403). The test substance and the analogue did not induce mortalities, abnormalities or clinical signs when applied oral. Also single administration of the analogue substance via the respiratory system did not cause health effects or mortalities. The LD50 for oral toxicity is considered to be > 5000 mg/kg bw, LC50 is > 5.24 mg/l air. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/292e4fc5-c10c-48db-848c-c95272b0d4c5/documents/afdfd1c7-d9de-4821-9abf-602a5c34a4ed_05c41673-7a56-411f-b0eb-4a35aae6cea2.html,,,,,, Calcium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate],1103-39-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/292e4fc5-c10c-48db-848c-c95272b0d4c5/documents/afdfd1c7-d9de-4821-9abf-602a5c34a4ed_05c41673-7a56-411f-b0eb-4a35aae6cea2.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Calcium bis[2-[(2-hydroxynaphthyl)azo]naphthalenesulphonate],1103-39-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/292e4fc5-c10c-48db-848c-c95272b0d4c5/documents/afdfd1c7-d9de-4821-9abf-602a5c34a4ed_05c41673-7a56-411f-b0eb-4a35aae6cea2.html,,inhalation,LC50,5.24 mg/m3,no adverse effect observed, Calcium bis[3-nitro-4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonate],12286-65-6,"Oral: Read-across, NOAEL (28d) >= 1 100 mg/kg bw/d, according to OECD 422, GLP-compliant, rat, 2012, K1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6ae85ff-37f1-4a7f-bab1-7c0ea14cd830/documents/IUC5-87893268-2b7d-47f6-986a-543e9b5da7f0_a9829f77-0d05-4385-8e49-11a40170342f.html,,,,,, Calcium bis[3-nitro-4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonate],12286-65-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6ae85ff-37f1-4a7f-bab1-7c0ea14cd830/documents/IUC5-87893268-2b7d-47f6-986a-543e9b5da7f0_a9829f77-0d05-4385-8e49-11a40170342f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,110 mg/kg bw/day",,rat Calcium bis[3-nitro-4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonate],12286-65-6,"Information on acute oral and dermal toxicity is partially derived from structural analogues (barium- and calcium-salts). Four studies were performed to evaluate acute oral and dermal toxicity of the test substance to the rat (according or similar to OECD 401, 402). The test substance did not induce any mortalities, abnormalities or clinical signs when applicated oral or dermal. The LD50 for oral and dermal toxicity is considered to be > 10.000 mg/kg bw and > 2000 mg/kg bw, respectively. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6ae85ff-37f1-4a7f-bab1-7c0ea14cd830/documents/IUC5-889c9590-e911-4dd9-ada2-bf42034b6202_a9829f77-0d05-4385-8e49-11a40170342f.html,,,,,, Calcium bis[3-nitro-4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonate],12286-65-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6ae85ff-37f1-4a7f-bab1-7c0ea14cd830/documents/IUC5-889c9590-e911-4dd9-ada2-bf42034b6202_a9829f77-0d05-4385-8e49-11a40170342f.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Calcium bis[3-nitro-4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonate],12286-65-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6ae85ff-37f1-4a7f-bab1-7c0ea14cd830/documents/IUC5-889c9590-e911-4dd9-ada2-bf42034b6202_a9829f77-0d05-4385-8e49-11a40170342f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Calcium bis[4-[[1-[[(2-chlorophenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate],71832-85-4,"Oral: Read-across, NOAEL (28d) >= 1 100 mg/kg bw/d, according to OECD 422, GLP-compliant, rat, 2012, K1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fce2f64-693d-4072-a28d-05701d513caa/documents/IUC5-c90bf50f-1acd-4f52-b25d-d452906520cd_7c6108c2-6634-41dc-941b-c33d20d5cbcd.html,,,,,, Calcium bis[4-[[1-[[(2-chlorophenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate],71832-85-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fce2f64-693d-4072-a28d-05701d513caa/documents/IUC5-c90bf50f-1acd-4f52-b25d-d452906520cd_7c6108c2-6634-41dc-941b-c33d20d5cbcd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,110 mg/kg bw/day",,rat Calcium bis[4-[[1-[[(2-chlorophenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate],71832-85-4,"Oral: LD50 (m/f) > 5 000 mg/kg bw, similar to OECD TG 401, no GLP, rat, 1978, K2 Dermal: Read-across, LD50 (m/f) > 2 000 mg/kg bw, rat, according to OECD TG 402, GLP-compliance, 1993, K2 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fce2f64-693d-4072-a28d-05701d513caa/documents/IUC5-acdfc20b-61f9-4086-858c-b111f6b25128_7c6108c2-6634-41dc-941b-c33d20d5cbcd.html,,,,,, Calcium bis[4-[[1-[[(2-chlorophenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate],71832-85-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fce2f64-693d-4072-a28d-05701d513caa/documents/IUC5-acdfc20b-61f9-4086-858c-b111f6b25128_7c6108c2-6634-41dc-941b-c33d20d5cbcd.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Calcium bis[4-[[1-[[(2-chlorophenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate],71832-85-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fce2f64-693d-4072-a28d-05701d513caa/documents/IUC5-acdfc20b-61f9-4086-858c-b111f6b25128_7c6108c2-6634-41dc-941b-c33d20d5cbcd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Calcium bis[4-[[1-[[(2-methylphenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate],12286-66-7,"Oral: NOAEL (28d) >= 1 100 mg/kg bw/d, according to OECD 422, GLP-compliant, rat, 2012, K1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/818ed45c-e30a-486d-9be2-46e630912acc/documents/IUC5-2b5311f0-4fc2-4e44-b2f1-38198c744fa5_68fbd508-6756-4824-8298-65b034303cf8.html,,,,,, Calcium bis[4-[[1-[[(2-methylphenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate],12286-66-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/818ed45c-e30a-486d-9be2-46e630912acc/documents/IUC5-2b5311f0-4fc2-4e44-b2f1-38198c744fa5_68fbd508-6756-4824-8298-65b034303cf8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,110 mg/kg bw/day",,rat Calcium bis[4-[[1-[[(2-methylphenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate],12286-66-7,"Oral: LD50 (m/f) > 10 000 mg/kg bw, similar to OECD TG 401, no GLP, rat, 1972, K2 Dermal: Read-across, LD50 (m/f) > 2 000 mg/kg bw, according to OECD TG 402, GLP-compliance, rat, 2011, K1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/818ed45c-e30a-486d-9be2-46e630912acc/documents/IUC5-4ed54b40-df78-4dfc-9e80-535b8c5e97bb_68fbd508-6756-4824-8298-65b034303cf8.html,,,,,, Calcium bis[4-[[1-[[(2-methylphenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate],12286-66-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/818ed45c-e30a-486d-9be2-46e630912acc/documents/IUC5-4ed54b40-df78-4dfc-9e80-535b8c5e97bb_68fbd508-6756-4824-8298-65b034303cf8.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Calcium bis[4-[[1-[[(2-methylphenyl)amino]carbonyl]-2-oxopropyl]azo]-3-nitrobenzenesulphonate],12286-66-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/818ed45c-e30a-486d-9be2-46e630912acc/documents/IUC5-4ed54b40-df78-4dfc-9e80-535b8c5e97bb_68fbd508-6756-4824-8298-65b034303cf8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate],43035-18-3,"Information from Read-across source (Pigment Red 146): After repeated oral gavage for 28 days to rats there were no changes in clinical appearance, functional observations, body weights, food consumption, clinical laboratory investigations, macroscopic examination, organ weights and microscopic examination that were considered to be an effect of treatment.From the results presented a No Observed Adverse Effect Level (NOAEL) of 1000 mg/kg/day was established for male and female rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/782dfcb4-a901-45e1-8fe7-69ce6359b9ce/documents/bde43005-10a6-489b-9211-02f27596250f_14d21fef-11c9-470a-8511-af6bab5d4f56.html,,,,,, Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate],43035-18-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/782dfcb4-a901-45e1-8fe7-69ce6359b9ce/documents/bde43005-10a6-489b-9211-02f27596250f_14d21fef-11c9-470a-8511-af6bab5d4f56.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate],43035-18-3,"Acute oral toxicity:  Female Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage at a dose of 10000 mg/kg bw (25% in demineralized water). No animal died during the 14 day observation period, resulting in a LD50 >10000 mg/kg bw. LD50, oral: >10000 mg/kg bw Acute dermal toxicity:  Single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated with neither mortality nor signs of toxicity. The dermal LD50 was determined to be > 2000 mg / kg body weight. LD50, dermal: >2000 mg/kg bw, Read-across from source substance Pigment Red 170.   Acute inhalation toxicity: Male and female Sprague Dawley rats were subjected to test acute inhalation toxicity. The test substance was administered for 4 h at a dose of 5.04 mg/L air. No animal died during the 14 day observation period, resulting in a LC50 > 5.04 mg/L air. LC50, inhalation > 5.04 mg/L air   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/782dfcb4-a901-45e1-8fe7-69ce6359b9ce/documents/7004488c-abcc-43e1-9793-3084e91c112e_14d21fef-11c9-470a-8511-af6bab5d4f56.html,,,,,, Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate],43035-18-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/782dfcb4-a901-45e1-8fe7-69ce6359b9ce/documents/7004488c-abcc-43e1-9793-3084e91c112e_14d21fef-11c9-470a-8511-af6bab5d4f56.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate],43035-18-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/782dfcb4-a901-45e1-8fe7-69ce6359b9ce/documents/7004488c-abcc-43e1-9793-3084e91c112e_14d21fef-11c9-470a-8511-af6bab5d4f56.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Calcium bis[4-[[3-[[2-hydroxy-3-[[(4-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]-4-methylbenzoyl]amino]benzenesulphonate],43035-18-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/782dfcb4-a901-45e1-8fe7-69ce6359b9ce/documents/7004488c-abcc-43e1-9793-3084e91c112e_14d21fef-11c9-470a-8511-af6bab5d4f56.html,,inhalation,LC50,> 5.04 mg/L,no adverse effect observed, Calcium cyanamide,156-62-7," Oral: There are several subacute and subchronic studies on calcium cyanamide available using the oral route. One subacute and one subchronic oral toxicity studies are available for calcium cyanamide technical grade and one subacute and four subchronic/chronic oral toxicity studies were performed with calcium cyanamide purum. Two studies were identified as key studies and were assessed together to derive a reasonable NOAEL. The one-year feeding study in rats was defined as key study as the test substance was administered over the longest period of time and the observation period was the most extended one among the evaluated studies. In addition, a 6-month repeated dose study with dogs was also chosen as the key study as dogs represent a second non-rodent species. Both key values (rat: LOAEL = 16 mg/kg bw/day, NOAEL = 1.3 mg/kg bw/day and dog: NOAEL = 14.6 mg/kg bw/day) are in the same range and represent reasonable reference figures. For derivation of the DNELs by the dermal and oral route, the chronic study in rats was chosen as the study period was longer compared to the dog study. Inhalation/dermal: In accordance with column 2 of REACH Annex IX, the test repeated dose toxicity after inhalation and dermal application (required in section 8.6) do not need to be conducted as repeated dose toxicity studies for oral application are available. Reference figures for dermal and inhalation exposure are thus, extrapolated from oral studies/ human data (oral). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/315ca962-610c-427e-92fa-319d10bf2410/documents/90d4f46a-5674-451f-bfa0-a404e6af3e23_64267232-b045-4ce7-b556-fc2160ac1d92.html,,,,,, Calcium cyanamide,156-62-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/315ca962-610c-427e-92fa-319d10bf2410/documents/90d4f46a-5674-451f-bfa0-a404e6af3e23_64267232-b045-4ce7-b556-fc2160ac1d92.html,Chronic toxicity – systemic effects,oral,NOAEL,1.3 mg/kg bw/day,,rat Calcium cyanamide,156-62-7," There are five studies available, in which the acute oral toxicity of calcium cyanamide is examined. One of the studies was performed in rats using Kalkstickstoff concentrations of up to 995 mg/kg bw (calcium cyanamide 20.5%) and was considered the most critical of the studies available and therefore defined as key study. Results of this investigation revealed an acute oral LD50 of 765 mg/kg bw, which is equivalent to 639 mg/kg bw calcium cyanamide technical grade. Another study on Kalkstickstoff (calcium cyanamide 63.5%) was performed in mice and supports the results of the abovementioned rat study with an LD50 of 1800 mg/kg bw. Other supporting studies were performed with PERLKA or pure calcium cyanamide in rats and mice. The acute inhalation toxicity potential of calcium cyanamide was studied in three studies. In two of the studies, rats were exposed to Kalkstickstoff either in the non-oiled (155 mg/m3 air) or oiled (312 mg/m3 air) form and it was reported that the acute LC50 was above the tested concentrations. A third study was conducted using PERLKA, resulting in an acute inhalation LC50 of 5.1 mg/L (5100 mg/m3), which is equal to 8.22 mg/L (8220 mg/m3) calcium cyanamide technical grade.  Two studies on the acute dermal toxicity are available using PERLKA at the limit dosage (2000 mg/kg bw). Rabbits showed erythema and oedema as well as necrotic patches and the acute median lethal dermal dosage was established at > 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/315ca962-610c-427e-92fa-319d10bf2410/documents/272c5155-8758-492e-ab38-1938c5e4427f_64267232-b045-4ce7-b556-fc2160ac1d92.html,,,,,, Calcium cyanamide,156-62-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/315ca962-610c-427e-92fa-319d10bf2410/documents/272c5155-8758-492e-ab38-1938c5e4427f_64267232-b045-4ce7-b556-fc2160ac1d92.html,,oral,LD50,639 mg/kg bw,adverse effect observed, Calcium di(octanoate),6107-56-8," There were no changes in the sex ratio, weight, and survival rate of offspring attributed to the effects of docosanic acid administration. In addition, morphological abnormalities in offspring were not observed in any docosanic acid administration group. These results conclude that under these test conditions, the NOAEL for repeated administration of docosanic acid in regard to toxicity is 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98ba401a-19af-441c-84d4-5ffa3c96e4ee/documents/95f29084-a183-4b26-8761-600019d508ac_ae1231d3-88f4-4b11-a99c-47eb69baf42a.html,,,,,, Calcium di(octanoate),6107-56-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98ba401a-19af-441c-84d4-5ffa3c96e4ee/documents/95f29084-a183-4b26-8761-600019d508ac_ae1231d3-88f4-4b11-a99c-47eb69baf42a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Calcium di(octanoate),6107-56-8," The acute oral toxicity of the test item is read-across from dilithium adipate. The acute oral toxicity of dilithium adipate was determined to be in the range 300 mg/kg bw - 2000 mg/kg bw dilithium adipate. Source and target substances are likely to dissociate after administration into metals ions and fatty acids due to the ionic bond between the metal cation and fatty acid ion being disrupted by polar aqueous media. The fatty acid component is not expected to be hazardous as it is potentially exempt from REACH under Annex V.   Fatty acids are an endogenous part of every living cell and are absorbed, digested and transported in animals and humans. When taken up by tissues, they can either be stored as triglycerides or can be oxidised via the ß-oxidation and tricarboxylic acid pathways. Alternative minor oxidation pathways can be found in the liver and kidney (ω-oxidation and ω-1 oxidation) and in peroxisomes for ß-methyl branched fatty acids (α-oxidation). The metabolic products can then be incorporated for example into membrane phospholipids. The fatty acid moieties of the lithium and calcium salts of fatty acids are natural constituents of the human body and essential components of a balanced human nutrition. Fatty acids, through their inclusion in REACH Annex V, are excluded from REACH registration requirements provided they are obtained from natural sources and not chemically modified, are not PBT or vPvB or give rise to an equivalent level of concern, and do not meet the criteria for classification as dangerous, except those classified only as flammable or skin or eye irritants. Therefore, they are considered not to be hazardous to humans. The main difference between source and target substances is the cation and therefore test organisms would be exposed to either calcium from the target substance or lithium from the source substance. For acute oral toxicity the source substance is considered to be a more toxic compared to the target, as lithium is classified for acute toxicity. The Science Committee for Food (SCF) have issued an opinion on the tolerable daily intake for calcium (2003), in which the upper tolerable daily intake of calcium from all sources for adults is 2500 mg/kg b.w/day; this is significantly higher than acute oral toxicity LD50 value reported for the source substance (300 – 2000 mg/kg). A published LD50 value for octanoic acid, the organic component of the target substance, is reported as 10080 mg/kg with a 95 % confidence interval of 8190 to 12370 mg/kg (Jenner et al. 1964). Therefore, calcium dioctanoate is likely to be less toxic than dilithium adipate and the toxicity seen in studies with lithium adipate is considered to be related to the lithium cation, not the fatty acid component. Read across from this substance for acute oral toxicity needs to be assessed taking into account that lithium is driving the toxicity, and therefore although data for this endpoint is read across from dilithium adipate it is used in combination with published information on calcium and fatty acids and the acute oral classification (Category 4) that is assigned to lithium adipate is not considered to be relevant for calcium dioctanoate.   References: Jenner PM, Hagan EC, Taylor JM, Cook EL and Fitzhugh OG. 1964. Food Flavourings and Compounds of Related Structure I. Acute Oral Toxicity. Fd Cosmet. Toxicol. Vol. 2, pp. 327-343 SCF (Scientific Committee on Food). 2003. Opinion of the Scientific Committee on Food on the Tolerable Upper Intake Level of Calcium (expressed on 4 April 2003). SCF/CS/NUT/UPPLEV/64 Final. http://ec.europa.eu/food/fs/sc/scf/out194_en.pdf ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98ba401a-19af-441c-84d4-5ffa3c96e4ee/documents/f648e005-ee40-4eb4-ab33-ee4183d74c16_ae1231d3-88f4-4b11-a99c-47eb69baf42a.html,,,,,, Calcium di(octanoate),6107-56-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98ba401a-19af-441c-84d4-5ffa3c96e4ee/documents/f648e005-ee40-4eb4-ab33-ee4183d74c16_ae1231d3-88f4-4b11-a99c-47eb69baf42a.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "Calcium diethyl bis[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate]",65140-91-2,"Repeated dose toxicity, 90-days, oral (feed), dog (Beagle): Dosage: 8.5, 24.7, 84.1 mg/kg bw/day for males and 9.2, 28.3, 90.2 mg/kg bw/day for females. NOAEL of 84.1 (males) and 90.2 mg/kg bw/day (females) was deduced. No treatment-related effects have been observed.Repeated dose toxicity, 90-days, oral (feed), rat (Sprague-Dawley):Dosage: 40, 122, 376 mg/kg bw/day for males and 48, 136, 420 mg/kg bw/day for females. NOEL of 122 (males) and 136 mg/kg bw/day (females) was deduced. Slight impairment of growth during the first 6 weeks of treatment, lower efficiency of food utilisation and elevated SAP levels among males were reported.Repeated dose toxicity, 28-days, oral (gavage), rat (Sprague-Dawley): Dosage: 100, 300, and 1000 mg/kg bw. NOEL of 100 mg/kg bw/day was deduced. The liver was identified as target organ, because the organ weight increased at 1000 and 300 mg/kg. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c85eeae-ad40-4e17-aa5f-59816726fc86/documents/IUC5-e527e1e9-e0d9-4d56-8bd4-f68c5daf32d8_6e024394-ec58-4827-bedb-515b21d70239.html,,,,,, "Calcium diethyl bis[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate]",65140-91-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c85eeae-ad40-4e17-aa5f-59816726fc86/documents/IUC5-e527e1e9-e0d9-4d56-8bd4-f68c5daf32d8_6e024394-ec58-4827-bedb-515b21d70239.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,84.1 mg/kg bw/day,,dog "Calcium diethyl bis[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate]",65140-91-2,"Acute toxicity, oral, Tif. RAI (SPF) rats (similar to OECD TG 401, adopted 1981): LD50 > 6000 mg/kg bw.Acute toxicity, oral, Chinese hamster (according to OECD TG 401, adopted 1981): LD50 > 2000 mg/kg bw.Acute toxicity, inhalation, Tif:RAIf (SPF) rats (equivalent to OECD TG 403, adopted 1981): LC0 > 2350 mg/m³ (aerosol).Acute toxicity, intraperitoneal, Tif:RAIf(SPF) rats: LD50 (male/female) = 662 mg/kg bw, LD50 (female) = 735 mg/kg bw, LD50 (male) = 595 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c85eeae-ad40-4e17-aa5f-59816726fc86/documents/IUC5-2cc789b3-1c63-4754-a757-1218a236b6a9_6e024394-ec58-4827-bedb-515b21d70239.html,,,,,, "Calcium diethyl bis[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate]",65140-91-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c85eeae-ad40-4e17-aa5f-59816726fc86/documents/IUC5-2cc789b3-1c63-4754-a757-1218a236b6a9_6e024394-ec58-4827-bedb-515b21d70239.html,,oral,LD50,"6,000 mg/kg bw",no adverse effect observed, "Calcium diethyl bis[[[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate]",65140-91-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c85eeae-ad40-4e17-aa5f-59816726fc86/documents/IUC5-2cc789b3-1c63-4754-a757-1218a236b6a9_6e024394-ec58-4827-bedb-515b21d70239.html,,inhalation,LC50,"2,350 mg/m3",no adverse effect observed, Calcium diformate,544-17-2,There was no systemic toxicity noted at the highest tested dose in oral rat studies with calcium diformate (28-day study; NOAEL 1000 mg/kg bw/day) or potassium diformate (90-day study; NOAEL 3000 mg/kg bw/day; corresponds to 3000 mg calcium diformate/kg bw/day). Dermal and inhalation studies are not available; these routes of exposure are not regarded to be relevant. There was no target organ except the stomach which showed local irritation. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2830129-2cbb-40c4-bca0-2b5e44c08aa3/documents/IUC5-7692dec0-ca53-4d55-a562-84131a10fba6_54cd178c-60d7-4c44-965c-cf82be10a3fe.html,,,,,, Calcium diformate,544-17-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2830129-2cbb-40c4-bca0-2b5e44c08aa3/documents/IUC5-7692dec0-ca53-4d55-a562-84131a10fba6_54cd178c-60d7-4c44-965c-cf82be10a3fe.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,000 mg/kg bw/day",,rat Calcium diformate,544-17-2,"Calcium diformate is of low acute toxicity (LD50, rat > 2000 mg/kg). Inhalation and dermal data are lacking but can be read across (dermal LD50 >2000 mg/kg bw; LC50 >0.64 mg/L [corrected for formula weight]) from sodium formate, because toxicological properties are deemed to depend on the formate anion whereas contributions of the metal cations are considered to be minor important. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2830129-2cbb-40c4-bca0-2b5e44c08aa3/documents/IUC5-c859eab1-37fc-4b74-b735-c57eddd76700_54cd178c-60d7-4c44-965c-cf82be10a3fe.html,,,,,, Calcium diformate,544-17-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2830129-2cbb-40c4-bca0-2b5e44c08aa3/documents/IUC5-c859eab1-37fc-4b74-b735-c57eddd76700_54cd178c-60d7-4c44-965c-cf82be10a3fe.html,,oral,LD50,"2,000 mg/kg bw",, Calcium diformate,544-17-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2830129-2cbb-40c4-bca0-2b5e44c08aa3/documents/IUC5-c859eab1-37fc-4b74-b735-c57eddd76700_54cd178c-60d7-4c44-965c-cf82be10a3fe.html,,dermal,LD50,"2,000 mg/kg bw",, Calcium diformate,544-17-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2830129-2cbb-40c4-bca0-2b5e44c08aa3/documents/IUC5-c859eab1-37fc-4b74-b735-c57eddd76700_54cd178c-60d7-4c44-965c-cf82be10a3fe.html,,inhalation,LC50,0.64 mg/m3,, Calcium dioleate,142-17-6,"Dose responsive localized dermal effects at the test site (dorsal surface), consisting of scabbed post dose findings and elevated dermal scores. These findings were most pronounced at 1000 mg/kg bw/day and were seen most frequently at this dose level. The findings at 300 mg/kg bw/day were at a lower incidence and with lower dermal scores. Dermal scores and findings at 100 mg/kg bw/day were comparable to the controls. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76e1709b-eb51-4fa5-a161-f4b582361a5c/documents/ad7bdac2-f925-4efd-9da1-4bb4851b6ea4_81860108-5785-49fc-a6ee-068ccb5f59bf.html,,,,,, Calcium dioleate,142-17-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76e1709b-eb51-4fa5-a161-f4b582361a5c/documents/ad7bdac2-f925-4efd-9da1-4bb4851b6ea4_81860108-5785-49fc-a6ee-068ccb5f59bf.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,089.75 mg/kg bw/day",,rat Calcium dioleate,142-17-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76e1709b-eb51-4fa5-a161-f4b582361a5c/documents/ad7bdac2-f925-4efd-9da1-4bb4851b6ea4_81860108-5785-49fc-a6ee-068ccb5f59bf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,500 mg/kg bw/day",,rat Calcium dioleate,142-17-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76e1709b-eb51-4fa5-a161-f4b582361a5c/documents/ad7bdac2-f925-4efd-9da1-4bb4851b6ea4_81860108-5785-49fc-a6ee-068ccb5f59bf.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.86 mg/cm2,adverse effect observed,rat Calcium dioleate,142-17-6,It is considered from the results that all the substances in the category of calcium salts of C14-C22 monocarboxylic acids exhibit a similar lack of acute oral and dermal toxicity potential across the entire category. There is no evidence of a relevant intrinsic acute oral or dermal toxicity requiring classification or substance specific RMMs. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76e1709b-eb51-4fa5-a161-f4b582361a5c/documents/041bff4c-dada-486a-8ba0-f9ca88df1b10_81860108-5785-49fc-a6ee-068ccb5f59bf.html,,,,,, Calcium dioleate,142-17-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76e1709b-eb51-4fa5-a161-f4b582361a5c/documents/041bff4c-dada-486a-8ba0-f9ca88df1b10_81860108-5785-49fc-a6ee-068ccb5f59bf.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Calcium dioleate,142-17-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76e1709b-eb51-4fa5-a161-f4b582361a5c/documents/041bff4c-dada-486a-8ba0-f9ca88df1b10_81860108-5785-49fc-a6ee-068ccb5f59bf.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Calcium disulphamate,13770-92-8,"The oral administration of the read-across substance Sodium sulphamate to rats by gavage, at dose levels of 100, 300 and 1000 mg/kg bw/day, did not result in any toxicologically significant effects. The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f59d6c4d-32b2-41cc-96fd-6742140172a7/documents/8ae057b0-845d-43bb-8031-193ef677acf9_68ff10d5-9a1b-4565-a9d1-6eb4ec21d19b.html,,,,,, Calcium disulphamate,13770-92-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f59d6c4d-32b2-41cc-96fd-6742140172a7/documents/8ae057b0-845d-43bb-8031-193ef677acf9_68ff10d5-9a1b-4565-a9d1-6eb4ec21d19b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Calcium disulphamate,13770-92-8, Two acute toxicity studies are available for the read-across substance sodium sulphamate: Acute oral toxicity: The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg bodyweight Acute dermal toxicity: The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f59d6c4d-32b2-41cc-96fd-6742140172a7/documents/71e04be9-bc0f-4180-8ab3-b9e0ce903762_68ff10d5-9a1b-4565-a9d1-6eb4ec21d19b.html,,,,,, Calcium disulphamate,13770-92-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f59d6c4d-32b2-41cc-96fd-6742140172a7/documents/71e04be9-bc0f-4180-8ab3-b9e0ce903762_68ff10d5-9a1b-4565-a9d1-6eb4ec21d19b.html,,oral,LD50,"2,500 mg/kg bw",, Calcium disulphamate,13770-92-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f59d6c4d-32b2-41cc-96fd-6742140172a7/documents/71e04be9-bc0f-4180-8ab3-b9e0ce903762_68ff10d5-9a1b-4565-a9d1-6eb4ec21d19b.html,,dermal,LD50,"2,000 mg/kg bw",, Calcium hexaboride,12007-99-7," An acute dermal lethality study was conducted on Calcium Hexaboride and an acute inhalation lethality study was conducted on a structural analog, Titanium Diboride. The results of the studies are:   Acute dermal LD50 is greater than 2,000 mg/kg body weight in rats when tested according to OECD 402 (2017).   Acute inhalation toxicity is greater than 5.05 mg/L, dust, in rats when tested according to OECD 403. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02818631-62a4-48f1-8c3d-1a0f233a8cab/documents/a6ae0e15-7b91-4976-8bbb-86a311ca36f2_3b9c4e67-a73f-4c2f-a50c-9b9f6762f033.html,,,,,, Calcium hydride,7789-78-8," The acute oral toxicity of calcium hydride has been waived. CaH2 reacts violently or is ignited by air; reacts exothermically with water or moisture producing hydrogen and calcium hydroxide, releases flammable gases on contact with water. Due to these physico-chemical properties, CaH2 was not tested for the oral acute toxicity. Nevertheless, CaH2 once reacted with either moisture or water, the substance produces gas (hydrogen) and calcium hydroxide. Therefore, a read-across with calcium hydroxide was also reported for this endpoint. According the existing study for oral acute toxicity made with OECD guideline N°425 on female rats with calcium dihydroxide, the LD50 is >2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2dea7b60-61bf-4e1d-92ce-3323bbd65fdf/documents/a2e4f282-0a32-4dd3-baaa-813e7fe0c877_470d907d-9abf-47cc-9768-b50f93efbfe9.html,,,,,, Calcium hydrogen phosphonate,21056-98-4,"No data on repeated-dose toxicity is available for phosphonic acid, calcium salt (1 :1). A combined 28-day oral + reproduction/developmental toxicity screening (OECD 422) in rat is available for phosphonic acid (13598-36-2) and used for read-across. The NOAEL was established to 250 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f590dca5-979f-4224-bfc9-f7bac84500ab/documents/e750a8d5-b30f-4532-b481-02450721dfa2_22c23d16-8c05-403d-b16b-e8184f0e928c.html,,,,,, Calcium hydrogen phosphonate,21056-98-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f590dca5-979f-4224-bfc9-f7bac84500ab/documents/e750a8d5-b30f-4532-b481-02450721dfa2_22c23d16-8c05-403d-b16b-e8184f0e928c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Calcium hydrogen phosphonate,21056-98-4,Acute toxicity potential of calcium hydrogen phosphonate was evaluated by oral route only. The oral LD50 is higher than 2000 mg/kg in rat. No data is available by dermal and inhalation route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f590dca5-979f-4224-bfc9-f7bac84500ab/documents/0cda93ee-2d42-45e9-b3d1-4cbc304fa6ec_22c23d16-8c05-403d-b16b-e8184f0e928c.html,,,,,, Calcium hydrogen phosphonate,21056-98-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f590dca5-979f-4224-bfc9-f7bac84500ab/documents/0cda93ee-2d42-45e9-b3d1-4cbc304fa6ec_22c23d16-8c05-403d-b16b-e8184f0e928c.html,,oral,LD0,"2,000 mg/kg bw",no adverse effect observed, Calcium magnesium dihydroxide oxide,58398-71-3,"Toxicity via the oral route is addressed by upper intake levels (UL) for adults determined by the Scientific Committee on Food (SCF), beingUL = 2500 mg/d, corresponding to 36 mg/kg bw/d (70 kg person) for calciumUL = 250 mg/d, corresponding to 3.6 mg/kg bw/d (70 kg person) for magnesium.Toxicity of calcium magnesium (di)hydroxide oxide via the dermal route is not considered as relevant.Toxicity of calcium magnesium (di)hydroxide oxide via inhalation (local effect, irritation of mucous membranes) is addressed by an 8-h TWA determined by the Scientific Committee on Occupational Exposure Limits (SCOEL) of 1 mg/m³. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93783869-62c6-4608-b6be-5aa7b4f17d5f/documents/IUC5-21d76225-4018-42fb-9c8a-1c8c32a587f6_38ed5003-830f-4e8b-9c89-e0fa16baba8b.html,,,,,, Calcium magnesium dihydroxide oxide,58398-71-3,Calcium magnesium (di)hydroxide oxide is not acutely toxic. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93783869-62c6-4608-b6be-5aa7b4f17d5f/documents/IUC5-1f60f560-17c6-4112-b276-718446344a15_38ed5003-830f-4e8b-9c89-e0fa16baba8b.html,,,,,, Calcium magnesium dihydroxide oxide,58398-71-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93783869-62c6-4608-b6be-5aa7b4f17d5f/documents/IUC5-1f60f560-17c6-4112-b276-718446344a15_38ed5003-830f-4e8b-9c89-e0fa16baba8b.html,,oral,LD50,"2,000 mg/kg bw",, Calcium magnesium oxide,37247-91-9,"Toxicity via the oral route is addressed by upper intake levels (UL) for adults determined by the Scientific Committee on Food (SCF), beingUL = 2500 mg/d, corresponding to 36 mg/kg bw/d (70 kg person) for calciumUL = 250 mg/d, corresponding to 3.6 mg/kg bw/d (70 kg person) for magnesium.Toxicity of calcium magnesium oxide via the dermal route is not considered as relevant.Toxicity of calcium magnesium oxide via inhalation (local effect, irritation of mucous membranes) is addressed by an 8-h TWA determined by the Scientific Committee on Occupational Exposure Limits (SCOEL) of 1 mg/m³. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/755e6479-537c-4ca2-9da5-82bb1c2a4fa4/documents/IUC5-d53a8d3d-c152-4a1f-a1ad-e978d6977401_e3965132-3a41-4435-bec9-02fb6cf2657f.html,,,,,, Calcium magnesium oxide,37247-91-9,"Calcium magnesium oxide is not acutely toxic via the oral, dermal, or inhalation route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/755e6479-537c-4ca2-9da5-82bb1c2a4fa4/documents/IUC5-522e8af1-0a6c-479c-aad5-dc9bc2f4521b_e3965132-3a41-4435-bec9-02fb6cf2657f.html,,,,,, Calcium magnesium oxide,37247-91-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/755e6479-537c-4ca2-9da5-82bb1c2a4fa4/documents/IUC5-522e8af1-0a6c-479c-aad5-dc9bc2f4521b_e3965132-3a41-4435-bec9-02fb6cf2657f.html,,oral,LD50,"2,000 mg/kg bw",, Calcium molybdate,7789-82-4,"NOAEL for systemic toxicity, oral, from a sub-chronic study with sodium molybdate dihydrate in rats (Hoffman, 2011): 17 mg Mo/kg bw/day. Unbounded NOAEC for systemic toxicity, inhalation, from a sub-chronic study with molybdenum trioxide in rats and mice (NTP, 1997): 66.7 mg Mo/m³. Important: both values expressed based on element Mo (for read-across purposes), not on the respective test substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9cfdf682-7921-404f-a794-02c205996425/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_eeff6443-47df-42c2-b65d-d19cc8f1ce1e.html,,,,,, Calcium molybdate,7789-82-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9cfdf682-7921-404f-a794-02c205996425/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_eeff6443-47df-42c2-b65d-d19cc8f1ce1e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat Calcium molybdate,7789-82-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9cfdf682-7921-404f-a794-02c205996425/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_eeff6443-47df-42c2-b65d-d19cc8f1ce1e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,66.7 mg/m3,,other:rats and mice Calcium molybdate,7789-82-4," To avoid unnecessary (animal) testing, a comprehensive grouping and read-across concept has been developed amongst several molybdenum containing substances. Acute oral, inhalation and dermal toxicity studies are available for several but not all substances in the category. The following LD50s are therefore either based on test data for the substance in this dossier, or based on read-across within the category: For calcium molybdate: LD50 oral: > 2000 mg/kg  (estimated, based on category read-across) LD50 inhalation, 4h: > 5 g/m³ (estimated, based on category read-across) LD50 dermal: > 2000 mg/kg (estimated, based on category read-across) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9cfdf682-7921-404f-a794-02c205996425/documents/768b8c0b-9643-43e9-820e-fae398d0570e_eeff6443-47df-42c2-b65d-d19cc8f1ce1e.html,,,,,, "calcium,6-[(3-carboxylatopropanoyl)amino]-2-[(3-carboxypropanoyl)amino]hexanoate",1422423-64-0, Not harmful/toxic for repeated dose exposure ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89045d3d-00cd-418a-b2df-0b624dc83e59/documents/IUC5-6c08860f-b8a7-43f1-8d06-a83db17abeb9_651a7938-c91c-4004-a1ed-86dfbcc4e89f.html,,,,,, "calcium,6-[(3-carboxylatopropanoyl)amino]-2-[(3-carboxypropanoyl)amino]hexanoate",1422423-64-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89045d3d-00cd-418a-b2df-0b624dc83e59/documents/IUC5-6c08860f-b8a7-43f1-8d06-a83db17abeb9_651a7938-c91c-4004-a1ed-86dfbcc4e89f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,250 mg/kg bw/day",,rat "calcium,6-[(3-carboxylatopropanoyl)amino]-2-[(3-carboxypropanoyl)amino]hexanoate",1422423-64-0, LD50 (oral) > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89045d3d-00cd-418a-b2df-0b624dc83e59/documents/IUC5-42b2a730-fa87-49dc-9a11-edd1c938cbac_651a7938-c91c-4004-a1ed-86dfbcc4e89f.html,,,,,, "calcium,6-[(3-carboxylatopropanoyl)amino]-2-[(3-carboxypropanoyl)amino]hexanoate",1422423-64-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89045d3d-00cd-418a-b2df-0b624dc83e59/documents/IUC5-42b2a730-fa87-49dc-9a11-edd1c938cbac_651a7938-c91c-4004-a1ed-86dfbcc4e89f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Calcium neodecanoate,27253-33-4," No repeated dose toxicity study with calcium neodecanoate is available, thus the repeated dose toxicity will be addressed with existing data on the individual moieties calcium and neodecanoate. In relevant and reliable repeated dose toxicity studies as well as supporting studies for both moieties of calcium neodecanoate, there were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2513a1de-b0d7-47d0-b18d-32e282ccfdba/documents/adb93ea6-abab-4895-ae49-3044de7d5fc8_87f8adc2-8230-4bd0-965d-b1cdef7c521c.html,,,,,, Calcium neodecanoate,27253-33-4," No acute toxicity studies with calcium neodecanoate are available, thus the acute toxicity will be addressed with existing data on the dissociation products calcium and neodecanoate. Signs of acute oral or acute dermal toxicity are not expected for calcium neodecanoate, since the two moieties calcium and neodecanoic acid have not shown signs of acute oral or acute dermal toxicity in experimental testing (both LD50 > 2000mg/kg). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2513a1de-b0d7-47d0-b18d-32e282ccfdba/documents/06c8c195-fd9f-46e7-b291-4a743fb1e548_87f8adc2-8230-4bd0-965d-b1cdef7c521c.html,,,,,, Calcium nitrate,10124-37-5,"A reliable 28-day oral OECD 422 study has been performed in rats (5 rats/sex/dose) via gavage, containing 50, 750 or 1500 mg/kg bw/day potassium nitrate. There were no treatment-related deaths and no signs of overt clinical toxicity. There were no effects on body weight, food consumption, or food efficiency. Functional observational battery (FOB) and motor activity tests identified no treatment-related changes in behavior, function, or motor activity. No treatment-related histopathological changes were reported. Therefore, it was concluded that the NOAEL is ≥ 1500 mg KNO3/kg bw/day, ≥920 mg nitrate/kg bw/day (or higher, highest dose tested). A reliable 28 -day oral OECD 407, EU B.7 guideline study has been performed in rats (5 rats/sex/dose) via gavage, containing 50, 150 or 1000 mg/kg bw/day Nitcal-K (potassium pentacalcium nitrate decahydrate). There were no treatment-related deaths and no signs of overt clinical toxicity. There were no effects on body weight, food consumption, or food efficiency. Functional observational battery (FOB) and motor activity tests identified no treatment-related changes in behavior, function, or motor activity. In haematology high-dose males reticulocytes and red cell distribution width were slightly increased; in high-dose females red blood cell count and haematocrit was slightly decreased. Reviewer: these changes are not consistent between males/females, are very slight, and three out of four appeared to be in the historical control range from this strain (based on NOTOX historical data) and this kind of study. Therefore, these are not considered adverse. At gross pathology a thickened limiting ridge and/or foci in glandular mucosa in 2 and 3 high-dose males and females, respectively, were noted. This is a local effect and reversible. At histopathology some non-neoplastic effects were observed: hyperplasia/hyperkeratosis of the limiting ridge of the stomach in 4 and 3 high dose males and females, respectively. This is considered a local effect and reversible according to the reviewer. In addition an increased severity of haemopoietic foci (erythroid) in the spleen at high dose was noted. Reviewer: The effect in the spleen is limited to one male and one female with a moderate severity at the high dose. However, this is a symptom expected in young animals in such a study, in addition it is considered a reversible effect. This is based on expertise of an experienced pathologist. Therefore, it was concluded that the NOAELsystemic is ≥1000 mg Nitcal-K/kg bw/day, ≥56 mg nitrate/kg bw/day(highest dose tested).  In conclusion, no systemic adverse effects were observed up to and including the highest dose tested in two 28-day oral toxicity studies. The data from the 104-week carcinogenicity study in rats (Maekawa et al., 1982) do not indicate adverse toxic effects / carcinogenic potential of sodium nitrate. The Maekawa et al. (1982) study was used by SCF and EFSA for the derivation of the ADI.  F344 rats (50 animals per sex per group, 8 weeks old) were given 0%, 2.5% and 5% sodium nitrate in the diet ad libitum (equivalent to 0, 1250 and 2500 mg/kg bw per day, or 0, 910, or 1820 mg/kg bw per day expressed as nitrate ion) in a 2-year feeding study (Maekawa et al., 1982). Rats in the control group were given a basic diet without nitrate ad libitum. Treatment was stopped at week 104 and the rats were given a basic diet until week 123 to account for the number of survivors in at least one group of either sex that was less than 20%. Diet and water consumption was constant in all groups throughout the study. The growth curves showed that the mean body weight of male fats did not differ more than 10%, whereas female rats differed by more than 10% in the high-dose group after week 60. However, no statistically significant differences were reported for this parameter. Treatment with sodium nitrate did not have statistically significant effect on survival rates, although male rats in the 5% group (equivalent to 2500 mg sodium nitrate/kg bw per day, 1820 mg nitrate ion/kg bw per day) had 10% higher cumulative mortality compared to the 2.5% group (equivalent to 1250 mg sodium nitrate/kg bw per day, 910 mg nitrate ion/kg bw per day). At the end of the study (2 years), both male and female control groups showed a statistically significant lower number of survivors compared to both treatment groups. However, the mean survival time did not differ significantly among all groups. The incidence of tumours in all groups, including controls, was high. For example, the percentage of animals showing tumours in the control groups was reported to reach 94% and 92% for male and female rats, respectively. In male rats from the 2.5% sodium nitrate group (equivalent to 1250 mg/kg bw per day, 910 nitrate ion/kg bw per day), tumour incidence was reported to be 100%, whereas, in male rats from the 5% dose group (equivalent to 2500 mg/kg bw per day, 1820 mg nitrate ion/kg bw per day), the incidence was 96%. All other groups showed lower absolute tumour incidences than controls. The most commonly observed tumour in males was in the testes (interstitial cell) followed by the mammary gland, adrenal gland and liver. Tumours of the mammary gland, pituitary gland, uterus and adrenal gland were the most commonly observed tumours in females. Overall, there was no statistically significant difference of any specific tumour. The time of appearance of the first background tumour was not affected in any treatment group. Only the incidences of tumours of the haematopoietic organs were reported to be statistically significantly lower in the treated groups compared to controls, especially concerning mononuclear cell leukaemia. In conclusion, no adverse effects were observed up to and including the highest dose tested. Sodium nitrate did not have carcinogenic activity in F344 rats when administered continuously for 2 years. In conclusion, no carcinogenic effects were observed and the NOAEL for adverse toxic effects is ≥2500 mg sodium nitrate/kg bw/day, ≥1820 mg nitrate/kg bw/day (highest dose tested). Expert statement: Based on the existing data, read across and current ADI values no relevant toxicity after sub-chronic exposure is expected. Overall, generation of additional sub-chronic oral toxicity data is considered not scientifically justified and the sub-chronic oral toxicity study (90-days) thus waived. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/107820de-8255-4e1a-b309-84934ee3e31e/documents/e091d179-cc37-4f8f-924d-f1e063b890e3_d8f89a98-ff08-4bf7-9998-f6127017a06f.html,,,,,, Calcium nitrate,10124-37-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/107820de-8255-4e1a-b309-84934ee3e31e/documents/e091d179-cc37-4f8f-924d-f1e063b890e3_d8f89a98-ff08-4bf7-9998-f6127017a06f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,920 mg/kg bw/day,,rat Calcium nitrate,10124-37-5,"Based on a reliable acute oral toxicity study with calcium nitrate (OECD 423) the LD50 is determined to be >300 mg/kg bw and <2000 mg/kg bw for calcium nitrate (LD50 cut-off value 1000 mg/kg bw). No acute dermal toxicity study with calcium nitrate is available. However, a reliable acute dermal toxicity study with Nitcal-K showed an LD50>2000 mg/kg bw.  An acute inhalation study is not considered necessary as the vapour pressure is assumed to be very low and the particle size of calcium nitrate is very high with 50% of the particles > 2000 micrometer, which shows that inhalation is an very unlikely route of exposure. The read-across rationale can be found in the document attached in the appropriate target record and is fully incorporated in the CSR (see Appendix A). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/107820de-8255-4e1a-b309-84934ee3e31e/documents/a9b2b74e-276a-4d33-a9a3-ad2e7b2122d3_d8f89a98-ff08-4bf7-9998-f6127017a06f.html,,,,,, Calcium nitrate,10124-37-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/107820de-8255-4e1a-b309-84934ee3e31e/documents/a9b2b74e-276a-4d33-a9a3-ad2e7b2122d3_d8f89a98-ff08-4bf7-9998-f6127017a06f.html,,oral,LD50,"ca.1,000 mg/kg bw",adverse effect observed, Calcium nitrate,10124-37-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/107820de-8255-4e1a-b309-84934ee3e31e/documents/a9b2b74e-276a-4d33-a9a3-ad2e7b2122d3_d8f89a98-ff08-4bf7-9998-f6127017a06f.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Calcium phosphinate,7789-79-9, Oral route: NOAEL males (28 d) > 86.9 mg/kg bw/day; female NOAEL (28 d) = 35.2 mg/kg bw/day). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09ac593f-ed04-4508-b91f-2b82c4d5fc1d/documents/IUC5-4b512c39-11e1-4996-ba92-79af78ca2b00_28d560d3-f41a-4b17-898c-9e954a4759e5.html,,,,,, Calcium phosphinate,7789-79-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09ac593f-ed04-4508-b91f-2b82c4d5fc1d/documents/IUC5-4b512c39-11e1-4996-ba92-79af78ca2b00_28d560d3-f41a-4b17-898c-9e954a4759e5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,35.2 mg/kg bw/day,,rat Calcium phosphinate,7789-79-9, Oral route: LD50 = 2000 mg/kg bw Inhalation route: LC50 (4h) > 3.30 mg/L Dermal route: LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09ac593f-ed04-4508-b91f-2b82c4d5fc1d/documents/IUC5-1a62d15a-e418-416c-bcf6-fc8637e298b9_28d560d3-f41a-4b17-898c-9e954a4759e5.html,,,,,, Calcium phosphinate,7789-79-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09ac593f-ed04-4508-b91f-2b82c4d5fc1d/documents/IUC5-1a62d15a-e418-416c-bcf6-fc8637e298b9_28d560d3-f41a-4b17-898c-9e954a4759e5.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Calcium phosphinate,7789-79-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09ac593f-ed04-4508-b91f-2b82c4d5fc1d/documents/IUC5-1a62d15a-e418-416c-bcf6-fc8637e298b9_28d560d3-f41a-4b17-898c-9e954a4759e5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Calcium phosphinate,7789-79-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09ac593f-ed04-4508-b91f-2b82c4d5fc1d/documents/IUC5-1a62d15a-e418-416c-bcf6-fc8637e298b9_28d560d3-f41a-4b17-898c-9e954a4759e5.html,,inhalation,LC50,"3,300 mg/m3",no adverse effect observed, Calcium sulfate,7778-18-9,Repeat dose oral: Evidence from human epidemiological studies and animal studies with repeated exposure do not show any severe toxicological effects after oral administration of calcium sulfate.   Repeat dose inhalation: The inhalation route is not considered a relevant route of exposure for calcium sulfate. Supporting physico-chemical and toxicological data do not show any evidence for local or systemic effects to to occur after inhalation of calcium sulfate. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fda98314-ed5a-426a-b8c7-217330fa9890/documents/41d303cb-968a-47a3-a4e3-9b62cb80fc41_1d86b92a-53e8-4058-8e1b-e32d3c4d817c.html,,,,,, Calcium sulfate,7778-18-9,"Calcium sulfate is not considered to be acutely toxic by the oral or inhalation route. The dermal toxicity of calcium sulfate is not considered to be relevant. Calcium sulfate is an inorganic ionic solid and is not expected to penetrate the skin. Furthermore, calcium sulfate is commonly used in Plaster of Paris, and is not known to have been associated with any toxic effects on the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fda98314-ed5a-426a-b8c7-217330fa9890/documents/7b08afd1-2463-4ab8-90a9-34bc4de5a7b7_1d86b92a-53e8-4058-8e1b-e32d3c4d817c.html,,,,,, Calcium sulphite,10257-55-3,"A 3-generation chronic toxicity study (Til et al. 1972a) with treatment of rats (20 per sex and group) with dose levels of 0, 0.125, 0.25, 0.5, 1.0 or 2.0% Na2S2O5 administered in a 50 ppm thiamine-containing diet was identified as most reliable study for repeated dose toxicity and was defined as key study (read-across info, see `discussion`). Based on the read across concept for the group of sulfite substances, this result is also applicable to calcium sulfite. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a45afde-8965-48e4-bb3b-43dc080615a4/documents/IUC5-5cad260a-223f-4180-be68-a2dc947aab04_594a5c85-7225-4897-940a-b26d28bc4039.html,,,,,, Calcium sulphite,10257-55-3,"Based on the described read-across methodology information from sodium sulfite (CAS 7757-83-7), sodium metabisulfite (CAS 7681 -57 -4) and potassium metabisulfite (CAS 16731 -55 -8) were used to determine acute toxicity values (oral, dermal and inhalative) for calcium sulfite.Please see `discussion` below. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a45afde-8965-48e4-bb3b-43dc080615a4/documents/IUC5-58cdf0f0-1897-4de4-83e5-dbfd48722d9b_594a5c85-7225-4897-940a-b26d28bc4039.html,,,,,, Calcium tetraborate,12007-56-6, The oral LD50 value of calcium metaborate in Wistar rats was established to exceed 2000 mg/kg body weight. Variations in structure (trigonal vs tetrahedral) between the substances are not expected to lead to any changes as at physiological pH as all the substances dissociate to provide the same common compounds. Read-across to the result for calcium metaborate is proposed for calcium tetraborate. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b66ea384-7977-441b-b35f-e551f8fbebea/documents/5aeb7683-4b93-40e5-8a98-85d2696f2aac_f5530b99-67e0-4dbe-b133-c307e9b9b2ca.html,,,,,, Calcium thiosulphate,10124-41-1,"A 3-generation chronic toxicity study (Til et al. 1972a) with treatment of rats (20 per sex and group) with dose levels of 0, 0.125, 0.25, 0.5, 1.0 or 2.0% Na2S2O5 administered in a 50 ppm thiamine-containing diet was identified as most reliable study for repeated dose toxicity and was defined as key study (read-across info, see `discussion`). Based on the read across concept for the group of sulfite and thiosulfate substances, this result is also applicable to calcium thiosulfate. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e30351ba-4089-4e7e-a7ee-d760bc09c9b5/documents/IUC5-f6c5a8f0-a86b-4ff9-ac8e-7ca92992e28c_9bb92a5e-5820-4902-937d-ed1eccc26562.html,,,,,, Calcium thiosulphate,10124-41-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e30351ba-4089-4e7e-a7ee-d760bc09c9b5/documents/IUC5-f6c5a8f0-a86b-4ff9-ac8e-7ca92992e28c_9bb92a5e-5820-4902-937d-ed1eccc26562.html,Chronic toxicity – systemic effects,oral,NOAEL,169 mg/kg bw/day,,rat Calcium thiosulphate,10124-41-1,"Acute toxicity values (oral, dermal and inhalative) were determined for calcium thiosulfate utilizing substance specific data and data from read-across to sodium sulfite (CAS 7757-83-7) and potassium thiosulfate (CAS 10294-66-3).Please see `discussion` below. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e30351ba-4089-4e7e-a7ee-d760bc09c9b5/documents/IUC5-2bc721d7-a29a-4b33-9563-5a42f9792810_9bb92a5e-5820-4902-937d-ed1eccc26562.html,,,,,, Calcium tin trioxide,12013-46-6,"In the absence of repeated dose toxicity data for CaSnO3 itself, a combined  read-across (see Section 13.2 read-across report) and Mixture rules approach is followed. Based on studies on Tin (II) oxide and Tin (IV) dioxide, calcium tin trioxide would not need to be classified under Regulation (EC) No 1272/2008 for Specific target organ toxicity - repeated exposure. To take into account toxicological profile/contribution of impurities, CLP Mixture rules are considered. Mixtures containing ≥ 10% or ≥ SCL of a substance classified repeated dose toxicity Cat 1, are classified specific target organ toxicity (repeated) Cat.1. Depending on the concentrations of the PbO impurity, calcium tin trioxide - boundary 2 (Pb < 0.1%) is not classified but calcium tin trioxide - boundary 1(PbO >= 0.5%) is classified repeated dose toxicity Cat.1. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04b395f3-9e42-4b64-8e91-29bb8e1f3595/documents/010220f8-3581-4458-8b7d-7907570dc131_f000ca09-c214-4aae-9760-471451206e5c.html,,,,,, Calcium tin trioxide,12013-46-6,"In the absence of acute toxicity data for CaSnO3 itself, a read-across approach from SnO2 (CAS 18282-10-5, EC 242-159-0) is followed (see Section 13.2 read-across report). In parallel, to take into account toxicological profile/contribution of impurities, classification based on CLP Mixture rules is considered. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04b395f3-9e42-4b64-8e91-29bb8e1f3595/documents/IUC5-839f61d4-57de-431b-8f93-fe6f94c1f808_f000ca09-c214-4aae-9760-471451206e5c.html,,,,,, Calcium zirconium oxide,11129-15-0,"1. Information on zirconium dioxideOral route:Two studies were used in a weight of evidence approach to cover this endpoint (same read across approach as in the zirconium dioxide dossier):- Rossiello (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test via oral route in rats with the 'water soluble' zirconium acetate according to OECD Guideline 422 (GLP). A NOAEL of >= 1000 mg/kg bw/day (as zirconium acetate anhydrous) was derived. No adverse systemic effects were reported in the study.- No effects were reported after oral administration to rats during 17 weeks of zirconium basic carbonate (hydrated form) in the form of a moist paste containing 20.9% zirconium dioxide equivalent. The total intake of zirconium dioxide during the test period was 0, 0.9, 9 and 103.5 g. The equivalent NOAEL for zirconium dioxide was >= 3150-7080 mg/kg bw/day (Harrison et al., 1951).Inhalation route:A key study was selected, reporting the results of a 30-day and a 60-day inhalation study with zirconium dioxide dust in cats, dogs, guinea pigs, rabbits and/or rats. No adverse effects were observed. The NOAEC was >= 100.8 mg ZrO2/m³ air in the 30-day study and >= 15.4 mg ZrO2/m³ air in the 60-day study) (Spiegl et al., 1956).2. Information on calcium oxideOnly supporting information is available in the dossier for calcium oxide (study summaries not included in this dossier). Further testing was waived. 3. Conclusion on calcium zirconium oxide A similar non-hazardous toxicological profile is assumed as for zirconium dioxide, based on the available data mentioned above. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a14ad52-ac05-4132-8279-b7efdd2c12b6/documents/IUC5-8222e5ee-4401-4afd-9f91-daad193e064c_0fca3b13-9c03-4911-a290-267a9124ae03.html,,,,,, Calcium zirconium oxide,11129-15-0,"1. Information on zirconium dioxideAcute toxicity: oralThe LD50-value for acute oral toxicity was determined via the acute toxic class method in female Sprague-Dawley rats and was > 5000 mg/kg bw.Acute toxicity: inhalationThe LC50 was determined in an acute inhalation toxicity study according to the acute toxic class method and was determined to be higher than 4.3 mg/L in male and female Crl:CD(SD) albino rats via nose-only inhalation exposure to dust aerosol of zirconium dioxide.Acute dermalNo available data2. Information on calcium oxideAcute toxicity: oralThe LD50-value for acute oral toxicity determined via the up-and-down procedure in Wistar rats was > 2000 mg/kg bw.Acute inhalationNo available dataAcute dermalNo available data3. Conclusion on calcium zirconium oxide Acute toxicity: oralIt is expected that the substance will have a similar hazard profile as the individual substances zirconium dioxide and calcium oxide. Based on reliable data available for the individual substances zirconium dioxide and calcium oxide, calcium zirconium oxide is not expected to cause any adverse acute toxic effects after oral intake up to a dose of 2000 mg/kg bw. Based on this information, calcium zirconium oxide does not need to be classified for acute oral toxicity.Acute toxicity: inhalationBecause for acute oral toxicity, the individual components calcium oxide and zirconium dioxide were found to be equally non-hazardous, read across from the most abundant component in the crystal lattice, i.e. zirconium dioxide, is performed to cover the endpoint of acute inhalation toxicity, with the LC50 being > 4.3 mg/L air (no adverse effects observed). Acute toxicity: dermalNo reliable data were available for acute toxicity via the dermal route of exposure, however, no acute toxicity after dermal exposure is to be expected based on the absence of acute toxicity after oral exposure up to and including at the limit test dose of 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a14ad52-ac05-4132-8279-b7efdd2c12b6/documents/IUC5-ebbf5c2b-532d-4753-902c-6ec49aca9370_0fca3b13-9c03-4911-a290-267a9124ae03.html,,,,,, Calcium(2+) 12-hydroxyoctadecanoate,3159-62-4,"Dose responsive localized dermal effects at the test site (dorsal surface), consisting of scabbed post dose findings and elevated dermal scores. These findings were most pronounced at 1000 mg/kg bw/day and were seen most frequently at this dose level. The findings at 300 mg/kg bw/day were at a lower incidence and with lower dermal scores. Dermal scores and findings at 100 mg/kg bw/day were comparable to the controls. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06e62d11-416b-48dd-beec-dd59ce9aa7bc/documents/IUC5-00704715-eed3-4694-a041-69d721b70306_a34411a7-8309-43e9-8ff6-1ad8cfc26ad8.html,,,,,, Calcium(2+) 12-hydroxyoctadecanoate,3159-62-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06e62d11-416b-48dd-beec-dd59ce9aa7bc/documents/IUC5-00704715-eed3-4694-a041-69d721b70306_a34411a7-8309-43e9-8ff6-1ad8cfc26ad8.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,089.75 mg/kg bw/day",,rat Calcium(2+) 12-hydroxyoctadecanoate,3159-62-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06e62d11-416b-48dd-beec-dd59ce9aa7bc/documents/IUC5-00704715-eed3-4694-a041-69d721b70306_a34411a7-8309-43e9-8ff6-1ad8cfc26ad8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,500 mg/kg bw/day",,rat Calcium(2+) 12-hydroxyoctadecanoate,3159-62-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06e62d11-416b-48dd-beec-dd59ce9aa7bc/documents/IUC5-00704715-eed3-4694-a041-69d721b70306_a34411a7-8309-43e9-8ff6-1ad8cfc26ad8.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.86 mg/cm2,adverse effect observed,rat Calcium(2+) 12-hydroxyoctadecanoate,3159-62-4,It is considered from the results that all the substances in the category of calcium salts of C14-C22 monocarboxylic acids exhibit a similar lack of acute oral and dermal toxicity potential across the entire category. There is no evidence of a relevant intrinsic acute oral or dermal toxicity requiring classification or substance specific RMMs. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06e62d11-416b-48dd-beec-dd59ce9aa7bc/documents/IUC5-64c918c7-4259-4201-9aed-871240fa0275_a34411a7-8309-43e9-8ff6-1ad8cfc26ad8.html,,,,,, Calcium(2+) 12-hydroxyoctadecanoate,3159-62-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06e62d11-416b-48dd-beec-dd59ce9aa7bc/documents/IUC5-64c918c7-4259-4201-9aed-871240fa0275_a34411a7-8309-43e9-8ff6-1ad8cfc26ad8.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Calcium(2+) 12-hydroxyoctadecanoate,3159-62-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06e62d11-416b-48dd-beec-dd59ce9aa7bc/documents/IUC5-64c918c7-4259-4201-9aed-871240fa0275_a34411a7-8309-43e9-8ff6-1ad8cfc26ad8.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Calcium, carbonate hydroxy aluminum complexes",97660-35-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/515cfb33-7395-4b4b-ab83-78ab326d21a2/documents/IUC5-de9df517-e2b9-41b4-9542-2c592541c56c_5248b980-f4aa-441d-8ea3-f06373fc85e0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Calcium, carbonate hydroxy aluminum complexes",97660-35-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/515cfb33-7395-4b4b-ab83-78ab326d21a2/documents/IUC5-de9df517-e2b9-41b4-9542-2c592541c56c_5248b980-f4aa-441d-8ea3-f06373fc85e0.html,Chronic toxicity – systemic effects,inhalation,NOAEC,2.5 mg/m3,, "Calcium, carbonate hydroxy aluminum complexes",97660-35-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/515cfb33-7395-4b4b-ab83-78ab326d21a2/documents/IUC5-3d54ad79-ff02-48d4-8ee6-065bc40525e9_5248b980-f4aa-441d-8ea3-f06373fc85e0.html,,oral,LD50,"2,000 mg/kg bw",, "Calcium, carbonate hydroxy aluminum complexes",97660-35-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/515cfb33-7395-4b4b-ab83-78ab326d21a2/documents/IUC5-3d54ad79-ff02-48d4-8ee6-065bc40525e9_5248b980-f4aa-441d-8ea3-f06373fc85e0.html,,dermal,LD50,"2,000 mg/kg bw",, "Calcium, carbonate hydroxy aluminum complexes",97660-35-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/515cfb33-7395-4b4b-ab83-78ab326d21a2/documents/IUC5-3d54ad79-ff02-48d4-8ee6-065bc40525e9_5248b980-f4aa-441d-8ea3-f06373fc85e0.html,,inhalation,discriminating conc.,2.5 mg/m3,, "Carbamic acid, (2-hydroxypropyl)-, compd. with 1-amino-2-propanol (1:1)",169115-74-6,"In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) 1-amino-2-propanol was administered orally via gavage to groups of 12 male and 12 female Wistar rats at doses of 100, 300, and 1000 mg/kg body weight/day. Duration of treatment covered a 2 week premating period and a mating period in both sexes, approximately 2 weeks post-mating in males (in total 38 days exposure), and the entire gestation period and 4 days of lactation in females (in total 46 days of exposure). The NOAEL for general, systemic toxicity of the test substance is 300 mg/kg bw/day for the parental males based on some indications for a mild anemic process. The NOAEL for repeated dose toxicity of carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) is considered as 300 mg/kg bw per day, based on indications for a mild anemic process in males after oral uptake of the cleavage product 1-amino-2-propanol. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a9f9532-99eb-49d8-b331-5a9ead8e5ebd/documents/IUC5-994bbd4c-2852-4d92-9265-a19dfbec0b93_ce6a52f6-2035-489f-bc6b-1b4d3b9c97e9.html,,,,,, "Carbamic acid, (2-hydroxypropyl)-, compd. with 1-amino-2-propanol (1:1)",169115-74-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a9f9532-99eb-49d8-b331-5a9ead8e5ebd/documents/IUC5-994bbd4c-2852-4d92-9265-a19dfbec0b93_ce6a52f6-2035-489f-bc6b-1b4d3b9c97e9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Carbamic acid, (2-hydroxypropyl)-, compd. with 1-amino-2-propanol (1:1)",169115-74-6,"The acute oral LD50 of carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) is considered to be > 2000 mg/kg bw, based on studies with the immediate cleavage product 1-amino-2-propanol.The acute dermal LD50 of carbamic acid, (2-hydroxypropyl)-, compound with 1-amino-2-propanol (1:1) is considered to be > 2000 mg/kg bw, based on studies with the substance in ethylene glycol.No reliable data are available for acute inhalation toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a9f9532-99eb-49d8-b331-5a9ead8e5ebd/documents/IUC5-24b50b3b-31ae-45b0-8887-779c86996eb7_ce6a52f6-2035-489f-bc6b-1b4d3b9c97e9.html,,,,,, "Carbamic acid, (2-hydroxypropyl)-, compd. with 1-amino-2-propanol (1:1)",169115-74-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a9f9532-99eb-49d8-b331-5a9ead8e5ebd/documents/IUC5-24b50b3b-31ae-45b0-8887-779c86996eb7_ce6a52f6-2035-489f-bc6b-1b4d3b9c97e9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Carbamic acid, (2-hydroxypropyl)-, compd. with 1-amino-2-propanol (1:1)",169115-74-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a9f9532-99eb-49d8-b331-5a9ead8e5ebd/documents/IUC5-24b50b3b-31ae-45b0-8887-779c86996eb7_ce6a52f6-2035-489f-bc6b-1b4d3b9c97e9.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, benzyl[(2S)-1-[(2-aminoethyl)amino]-3-(4-ethoxyphenyl)propan-2-yl]carbamate dihydrochlorid,221640-14-8,"LD50 oral (rat):> 300 < 2000 mg/kg bw [report, Lewin 2005]LD50 dermal (rat): > 2000 mg/kg bw [report, Lewin 2004] ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18f9c53c-5f35-453d-b2c6-5e53dd5dd8e0/documents/IUC5-3729ac31-82a5-4e73-83ea-d291140deb90_74c75523-0986-4916-b9b0-9121d81e39c8.html,,,,,, benzyl[(2S)-1-[(2-aminoethyl)amino]-3-(4-ethoxyphenyl)propan-2-yl]carbamate dihydrochlorid,221640-14-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18f9c53c-5f35-453d-b2c6-5e53dd5dd8e0/documents/IUC5-3729ac31-82a5-4e73-83ea-d291140deb90_74c75523-0986-4916-b9b0-9121d81e39c8.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, benzyl[(2S)-1-[(2-aminoethyl)amino]-3-(4-ethoxyphenyl)propan-2-yl]carbamate dihydrochlorid,221640-14-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18f9c53c-5f35-453d-b2c6-5e53dd5dd8e0/documents/IUC5-3729ac31-82a5-4e73-83ea-d291140deb90_74c75523-0986-4916-b9b0-9121d81e39c8.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, benzyl N-(2-cyanopropan-2-yl)carbamate,100134-82-5, Experimental data from supplier. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49670e26-e532-4562-ad77-2aef3f080678/documents/0dc71600-a385-4631-87a1-fbc2659998b9_6a3ed168-92eb-4c7e-a0ec-dd9c3a8d64d2.html,,,,,, benzyl N-(2-cyanopropan-2-yl)carbamate,100134-82-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49670e26-e532-4562-ad77-2aef3f080678/documents/0dc71600-a385-4631-87a1-fbc2659998b9_6a3ed168-92eb-4c7e-a0ec-dd9c3a8d64d2.html,,oral,LD50,506 mg/kg bw,adverse effect observed, "Carbamic acid, N-[(1R)-2-hydroxy-1-phenylethyl]-, 1,1-dimethylethyl ester",102089-74-7, The results from the acute oral and acute dermal toxicity studies indicated that there was no indication of toxicity. The results from the acute inhalation toxicity study indicated that there was a positive indication of toxicity. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4da5a22b-4300-4793-b8c6-afb0b614b09f/documents/cb665bdd-d05e-48a3-9eb8-806b0e7bed22_80c12614-aa9e-4f20-b003-da240d9011ec.html,,,,,, "Carbamic acid, N-[(1R)-2-hydroxy-1-phenylethyl]-, 1,1-dimethylethyl ester",102089-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4da5a22b-4300-4793-b8c6-afb0b614b09f/documents/cb665bdd-d05e-48a3-9eb8-806b0e7bed22_80c12614-aa9e-4f20-b003-da240d9011ec.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "Carbamic acid, N-[(1R)-2-hydroxy-1-phenylethyl]-, 1,1-dimethylethyl ester",102089-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4da5a22b-4300-4793-b8c6-afb0b614b09f/documents/cb665bdd-d05e-48a3-9eb8-806b0e7bed22_80c12614-aa9e-4f20-b003-da240d9011ec.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Carbamic acid, N-[(1R)-2-hydroxy-1-phenylethyl]-, 1,1-dimethylethyl ester",102089-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4da5a22b-4300-4793-b8c6-afb0b614b09f/documents/cb665bdd-d05e-48a3-9eb8-806b0e7bed22_80c12614-aa9e-4f20-b003-da240d9011ec.html,,inhalation,LC50,"2,970 mg/m3",no adverse effect observed, methyl N-{[dimethoxy(methyl)silyl]methyl}carbamate,23432-65-7,RDT oral (OECD 407): NOAEL = 150 mg/kg bw/day (males/females) RDT inhalation: no data availableRDT dermal: no data available ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb0c93bc-0697-48f9-ac72-07ca98f3190f/documents/d0e625e4-d034-45b7-87a2-148cdfe84f62_a5b1ed61-029c-4830-a684-e0f07fe5c47d.html,,,,,, methyl N-{[dimethoxy(methyl)silyl]methyl}carbamate,23432-65-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb0c93bc-0697-48f9-ac72-07ca98f3190f/documents/d0e625e4-d034-45b7-87a2-148cdfe84f62_a5b1ed61-029c-4830-a684-e0f07fe5c47d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat methyl N-{[dimethoxy(methyl)silyl]methyl}carbamate,23432-65-7,Oral (OECD 423): LD50 cut-off = 5000 mg/kg bwInhalation: no data available Dermal (OECD 402): LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb0c93bc-0697-48f9-ac72-07ca98f3190f/documents/08666b95-6170-4183-995b-dfbbc27c008f_a5b1ed61-029c-4830-a684-e0f07fe5c47d.html,,,,,, methyl N-{[dimethoxy(methyl)silyl]methyl}carbamate,23432-65-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb0c93bc-0697-48f9-ac72-07ca98f3190f/documents/08666b95-6170-4183-995b-dfbbc27c008f_a5b1ed61-029c-4830-a684-e0f07fe5c47d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, methyl N-{[dimethoxy(methyl)silyl]methyl}carbamate,23432-65-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb0c93bc-0697-48f9-ac72-07ca98f3190f/documents/08666b95-6170-4183-995b-dfbbc27c008f_a5b1ed61-029c-4830-a684-e0f07fe5c47d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "5-hydroxy-1-methyl-2-(1-methyl-1-phenoxycabonylamino-ethyl)-6-oxo-1,6-dihydro-pyrimidine-4-carboxylic acid 4-fluorobenzylamide",518048-02-7,An acute oral study determined a LD50 > 2000 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/745330dc-d6aa-445b-bce7-7b08965bc2f8/documents/IUC5-e296d5a5-8be7-469e-933e-0397c6254a1d_5444bbaa-902a-48f8-be7d-00591338b007.html,,,,,, "5-hydroxy-1-methyl-2-(1-methyl-1-phenoxycabonylamino-ethyl)-6-oxo-1,6-dihydro-pyrimidine-4-carboxylic acid 4-fluorobenzylamide",518048-02-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/745330dc-d6aa-445b-bce7-7b08965bc2f8/documents/IUC5-e296d5a5-8be7-469e-933e-0397c6254a1d_5444bbaa-902a-48f8-be7d-00591338b007.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Carbamic acid,N,N'-[1,3-phenylenebis[methyleneiminocarbonylimino(methyl-3,1-phenylene)]]bis-di-C11-14-isoalkylesters, C13-rich",865536-03-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d0f4253-0de4-4d75-9fd3-ab80d3153ae7/documents/cbc90fda-00de-4ea8-bb68-07979e5b9e43_d4ba0fdb-e2c8-439e-9ba6-a231ff209750.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Carbazole,86-74-8,"After oral administration of a single dose of 16000 mg carbazole/kg bw to male and female rats (5 each), no mortality was observed within the observation period of 14 days. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/409a70e4-9376-44c6-86f2-15976f8fb56d/documents/IUC5-343ab57c-dae2-44af-bbc2-df57406758bd_349274b7-9b89-4ff0-b00f-53f164dfc6d3.html,,,,,, "Carbohydrates and Sugars, hexitols, anhydro",100683-96-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): As a preliminary study, this study did not follow a specific guideline and was designed to allow selection of appropriate dose levels for use in the subsequent studies. This study is a 14 days dose range finding study for an OECD 422 test. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17da90a6-9488-4cab-a2df-bab9ee9f21b7/documents/IUC5-e278dc6e-ba9e-403a-913f-d1c9af36d1f6_7f47fa9f-c898-494e-bdc5-ca30de86c817.html,,,,,, "Carbohydrates and Sugars, hexitols, anhydro",100683-96-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17da90a6-9488-4cab-a2df-bab9ee9f21b7/documents/IUC5-e278dc6e-ba9e-403a-913f-d1c9af36d1f6_7f47fa9f-c898-494e-bdc5-ca30de86c817.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Carbohydrates and Sugars, hexitols, anhydro",100683-96-3,"The single-dose oral toxicity of Carbohydrates and Sugars, hexitols, anhydro - LAB 4623 was performed according to the acute toxic class method (OECD 423 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.Tris) in CRL:(WI) rats. Two groups of three female CRL:(WI) rats were treated with the test item at a dose level of 2000 mg/kg bw (Group 1 and Group 2). Under the conditions of this study, the acute oral LD50 value of the test item Carbohydrates and Sugars, hexitols, anhydro - LAB 4623 was found to be above 2000 mg/kg bw in female CRL:(WI) rats.An acute dermal toxicity study was performed with test item Carbohydrates and Sugars, hexitols, anhydro - LAB 4623 in CRL:(WI) rats, in compliance with OECD Guideline No.: 402.A limit test was carried out at 2000 mg/kg body weight (bw) in both sexes (5 rats/sex). The test item was applied as supplied as a single dermal 24-hour exposure followed by a 14-day observation period. The acute dermal median lethal dose (LD50) of the test item Carbohydrates and Sugars, hexitols, anhydro - LAB 4623 was found to be greater than 2000 mg/kg body weight in male and female CRL:(WI) rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17da90a6-9488-4cab-a2df-bab9ee9f21b7/documents/IUC5-05fe4b08-dcd6-4a0a-81af-7c39d4262ce7_7f47fa9f-c898-494e-bdc5-ca30de86c817.html,,,,,, "Carbohydrates and Sugars, hexitols, anhydro",100683-96-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17da90a6-9488-4cab-a2df-bab9ee9f21b7/documents/IUC5-05fe4b08-dcd6-4a0a-81af-7c39d4262ce7_7f47fa9f-c898-494e-bdc5-ca30de86c817.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Carbohydrates and Sugars, hexitols, anhydro",100683-96-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17da90a6-9488-4cab-a2df-bab9ee9f21b7/documents/IUC5-05fe4b08-dcd6-4a0a-81af-7c39d4262ce7_7f47fa9f-c898-494e-bdc5-ca30de86c817.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Carbon tetrafluoride,75-73-0,"The three analogues used for the read-across (trifluoromethane, pentafluoroethane and perfluoroethane) had low repeated-dose inhalation toxicity and presented no adverse effect up to 10 000 ppm (for trifluoromethane) to 50 000 ppm (for pentafluoromethane and perfluoroethane). As the read-across with these analogues is considered as approriate, the repeated-dose toxicity of carbon tetrafluoride is expected to be similar to these analogue’s values.   Moreover, according to Annex VII (section 8.6.1 of the Column 2) of REACH regulation, the repeated-dose oral toxicity and repeated-dose dermal toxicity studies does not need to be conducted because the substance is a gas. Consequently, during the use of the substance, inhalation is likely. Furthermore, the low Log Kow coefficient (<3) suggest a low potential for dermal absorption. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/322f3a93-cf8c-479f-9dc6-8c0dfb8c138b/documents/9bba1dec-1d0a-4fd2-ac0e-5355229dd93b_4c565aed-2f95-43ff-a3cf-1b8fec68cc6d.html,,,,,, Carbon tetrafluoride,75-73-0,"The three analogues used for the read-across (trifluoromethane, pentafluoroethane and perfluoroethane) had very low acute inhalation toxicity and presented an acute lethal toxicity by inhalation between 500 000 and 800 000 ppm. As the read-across with these analogues is considered as approriate, the acute toxicity of carbon tetrafluoride is expected to be similar to these analogue’s values.   Moreover, according to Annex VII (sections 8.5.1 and 8.5.3 of the Column 1) of REACH regulation, the acute oral toxicity and acute dermal toxicity studies does not need to be conducted because the substance is a gas.  Furthermore, the low Log Kow coefficient (<3) suggest a low potential for dermal absorption. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/322f3a93-cf8c-479f-9dc6-8c0dfb8c138b/documents/492edcd7-d23e-469d-a2db-cfea223dbe43_4c565aed-2f95-43ff-a3cf-1b8fec68cc6d.html,,,,,, "Carbonic acid disodium salt, reaction products with aniline, 4-nitrobenzenamine, p-phenylenediamine, sodium sulfide, sulfur and p-toluidine",90268-98-7," Under the conditions of an OECD 422 compliant study, the test item administered at 100, 300 or 1000 mg/kg bw/day (corrected doses; corresponding to uncorrected doses of 110.46, 331.38 and 1104.61 mg/kg bw/day, repsectively) by oral gavage did not cause signs of systemic toxicity and did not adversely influence the reproductive performance (gonad function, mating behavior, conception, parturition) in parental male and female Han:WIST rats. The development of the F1 offspring was not impaired from birth to post-natal day 13 at any dose level after repeated oral administration of dams. Based on these observations the No Observed Adverse Effect Levels (NOAEL) were determined as follows: NOAEL for systemic toxicity of male/female rats: 1000 mg/kg bw/day NOAEL for reproductive performance of male/ female rats: 1000 mg/kg bw/day NOAEL for F1 Offspring: 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0e90485-e765-4194-812e-1c9225060184/documents/8b68ccac-a7ef-4654-9f53-4b9c5180b590_f8997f8c-ffca-4e22-9042-bbd15f30e127.html,,,,,, "Carbonic acid disodium salt, reaction products with aniline, 4-nitrobenzenamine, p-phenylenediamine, sodium sulfide, sulfur and p-toluidine",90268-98-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0e90485-e765-4194-812e-1c9225060184/documents/8b68ccac-a7ef-4654-9f53-4b9c5180b590_f8997f8c-ffca-4e22-9042-bbd15f30e127.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Carbonic acid disodium salt, reaction products with aniline, 4-nitrobenzenamine, p-phenylenediamine, sodium sulfide, sulfur and p-toluidine",90268-98-7, The LD50 of the test item was found to be > 2000 mg dye/kg bw in rats (corrected dose). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0e90485-e765-4194-812e-1c9225060184/documents/c8418a0c-babf-4179-b1a9-adad73cecc6e_f8997f8c-ffca-4e22-9042-bbd15f30e127.html,,,,,, "Carbonic acid disodium salt, reaction products with aniline, 4-nitrobenzenamine, p-phenylenediamine, sodium sulfide, sulfur and p-toluidine",90268-98-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0e90485-e765-4194-812e-1c9225060184/documents/c8418a0c-babf-4179-b1a9-adad73cecc6e_f8997f8c-ffca-4e22-9042-bbd15f30e127.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "4-(bromoacetyl)-1,3-phenylene dimethyl biscarbonate",1428451-07-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/295fd6f5-1bd0-481b-916f-56adab998920/documents/IUC5-67be1e33-cffe-43db-bb7a-5263199c82d4_5e68ac1c-2c16-4716-a962-b582d1789b01.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Carbonic acid, compound with 2-aminoethanol (1:2)",21829-52-7,"Repeat dose toxicity of the registered substance is read across from repeat dose (oral and inhalation) studies on the analogue substance, monoethanolamine, which establish NOAELs and NOECs as detailed above which are directly applicable to the registered substance due to the expectation that the substance will decompose to monoethanolamine in aqueous media, thus exhibiting the same toxicity profile systemically. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd8ba61c-54fe-4d03-b6b0-5832042ce09b/documents/IUC5-e7fa84a5-6006-409e-8745-db11974130c4_2f6f1e38-4d47-44b5-944d-fb2ba4d78f01.html,,,,,, "Carbonic acid, compound with 2-aminoethanol (1:2)",21829-52-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd8ba61c-54fe-4d03-b6b0-5832042ce09b/documents/IUC5-e7fa84a5-6006-409e-8745-db11974130c4_2f6f1e38-4d47-44b5-944d-fb2ba4d78f01.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Carbonic acid, compound with 2-aminoethanol (1:2)",21829-52-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd8ba61c-54fe-4d03-b6b0-5832042ce09b/documents/IUC5-e7fa84a5-6006-409e-8745-db11974130c4_2f6f1e38-4d47-44b5-944d-fb2ba4d78f01.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,150 mg/m3,,rat "Carbonic acid, compound with 2-aminoethanol (1:2)",21829-52-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd8ba61c-54fe-4d03-b6b0-5832042ce09b/documents/IUC5-e7fa84a5-6006-409e-8745-db11974130c4_2f6f1e38-4d47-44b5-944d-fb2ba4d78f01.html,Repeated dose toxicity – local effects,inhalation,NOAEC,10 mg/m3,adverse effect observed,rat "Carbonic acid, compound with 2-aminoethanol (1:2)",21829-52-7,"No acute toxicity studies have been identified on the registered substance. However, read across to the minor constituent and analogue substance, monoethanolamine is justified (see read across justification attached in IUCLID Section 13). These data indicate that the substance is expected to be acutely toxic if ingested, but not via dermal or inhalation routes of exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd8ba61c-54fe-4d03-b6b0-5832042ce09b/documents/IUC5-a33c6f60-eaa6-4ed3-ae2b-c24fc3b30fc5_2f6f1e38-4d47-44b5-944d-fb2ba4d78f01.html,,,,,, "Carbonic acid, compound with 2-aminoethanol (1:2)",21829-52-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd8ba61c-54fe-4d03-b6b0-5832042ce09b/documents/IUC5-a33c6f60-eaa6-4ed3-ae2b-c24fc3b30fc5_2f6f1e38-4d47-44b5-944d-fb2ba4d78f01.html,,oral,LD50,"1,089 mg/kg bw",adverse effect observed, "Carbonic acid, compound with 2-aminoethanol (1:2)",21829-52-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd8ba61c-54fe-4d03-b6b0-5832042ce09b/documents/IUC5-a33c6f60-eaa6-4ed3-ae2b-c24fc3b30fc5_2f6f1e38-4d47-44b5-944d-fb2ba4d78f01.html,,dermal,LD50,"2,504 mg/kg bw",adverse effect observed, "Carbonic acid, compound with 2-aminoethanol (1:2)",21829-52-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd8ba61c-54fe-4d03-b6b0-5832042ce09b/documents/IUC5-a33c6f60-eaa6-4ed3-ae2b-c24fc3b30fc5_2f6f1e38-4d47-44b5-944d-fb2ba4d78f01.html,,inhalation,discriminating conc.,"1,300 mg/m3",no adverse effect observed, Ethyl methyl carbonate,623-53-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aaf04f2e-772f-40ce-9066-42447f092f24/documents/cc5f1b94-cd50-4ee0-9998-04fe82b3abe0_e1e90fbc-392a-4bd3-af23-aae8666106bf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Ethyl methyl carbonate,623-53-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aaf04f2e-772f-40ce-9066-42447f092f24/documents/575cf2ea-970e-48f4-9b3e-4565b8df5738_e1e90fbc-392a-4bd3-af23-aae8666106bf.html,,oral,LD50,"5,000 mg/kg bw",, Ethyl methyl carbonate,623-53-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aaf04f2e-772f-40ce-9066-42447f092f24/documents/575cf2ea-970e-48f4-9b3e-4565b8df5738_e1e90fbc-392a-4bd3-af23-aae8666106bf.html,,inhalation,LC50,"17,600 mg/m3",, "Carbonic acid, zinc salt, basic",51839-25-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2eb9ce5b-8851-40c8-9a74-a200a78dda0e/documents/d3dbfe8d-29df-4047-bae7-35d291fdb315_9095f22d-eb5d-409d-b41a-119c9b40a73b.html,Repeated dose toxicity – local effects,inhalation,BMCL10,0.971 mg/m3,adverse effect observed,rat "Carbonic acid, zinc salt, basic",51839-25-9,Acute oral toxicity: key study carried out according to OECD guideline no 423 indicating for zinc carbonate LD50 > 2000 mg/kg bw Acute inhalation toxicity: key study carried out according to OECD guideline no 403 indicating for zinc oxide LC50 > 5.7 mg/L/4hrs (read-across to zinc carbonate) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2eb9ce5b-8851-40c8-9a74-a200a78dda0e/documents/IUC5-a623b7ae-5865-45bc-9c9a-fd4627442456_9095f22d-eb5d-409d-b41a-119c9b40a73b.html,,,,,, "Carbonic acid, zinc salt, basic",51839-25-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2eb9ce5b-8851-40c8-9a74-a200a78dda0e/documents/IUC5-a623b7ae-5865-45bc-9c9a-fd4627442456_9095f22d-eb5d-409d-b41a-119c9b40a73b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Carbonic acid, zinc salt, basic",51839-25-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2eb9ce5b-8851-40c8-9a74-a200a78dda0e/documents/IUC5-a623b7ae-5865-45bc-9c9a-fd4627442456_9095f22d-eb5d-409d-b41a-119c9b40a73b.html,,inhalation,LC50,"5,700 mg/m3",no adverse effect observed, 3-methylbutoxymethanedithioic acid,2540-36-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Inhalation of potassium amyl xanthate produces adverse effects in the livers of dogs. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80c544a2-a6a8-4434-8090-b6e3e39730ff/documents/IUC5-6660ced6-ff11-4883-8430-a2aad1cec309_2a7ad9bf-3b56-422b-9015-98ac25621a84.html,,,,,, 3-methylbutoxymethanedithioic acid,2540-36-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80c544a2-a6a8-4434-8090-b6e3e39730ff/documents/IUC5-6660ced6-ff11-4883-8430-a2aad1cec309_2a7ad9bf-3b56-422b-9015-98ac25621a84.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,100 mg/m3,,dog 3-methylbutoxymethanedithioic acid,2540-36-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Note that acute oral toxicity has been assess on the range of substances and with the exception of one mouse study, all are in the Acute Toxic 4 category. The quality of the data base is considered sufficient for the purposes of classification and risk management. No further animal testing can be justified ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80c544a2-a6a8-4434-8090-b6e3e39730ff/documents/97f26243-9b7d-40ea-b88d-7830479132d9_2a7ad9bf-3b56-422b-9015-98ac25621a84.html,,,,,, 3-methylbutoxymethanedithioic acid,2540-36-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80c544a2-a6a8-4434-8090-b6e3e39730ff/documents/97f26243-9b7d-40ea-b88d-7830479132d9_2a7ad9bf-3b56-422b-9015-98ac25621a84.html,,oral,LD50,ca.500 mg/kg bw,adverse effect observed, 3-methylbutoxymethanedithioic acid,2540-36-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80c544a2-a6a8-4434-8090-b6e3e39730ff/documents/97f26243-9b7d-40ea-b88d-7830479132d9_2a7ad9bf-3b56-422b-9015-98ac25621a84.html,,inhalation,LC50,"7,690 mg/m3",adverse effect observed, Carbonohydrazide,497-18-7,"OECD 422 (Fulcher & Watson 2013): Initial effects on body weights and food intake during the first week of treatment precluded classifying either 75 or 150/100 mg/kg bw/day as a No Observed Effect Level (NOEL) for adult toxicity. However, as these effects did not persist following the lowering of the high dose level, a dosage of 100 mg/kg bw/day is classified as a No Observed Adverse Effect Level (NOAEL) for adult toxicity.   OECD TG422 14day DRF (Fulcher & Watson, 2013): high dose for main 422 should be between 100-150mg/kg bw/day based on observed toxicity. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study has been conducted according to OECD Guideline 422 and GLP and is adequately reported. The study has been assigned a reliability 1. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3121d563-eaa4-4fd6-baa2-3ae028fc2b63/documents/83737ead-58ea-48c0-871e-21bf78f4e255_4d2157ba-d13a-44b0-a6f5-04c60edf1275.html,,,,,, Carbonohydrazide,497-18-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3121d563-eaa4-4fd6-baa2-3ae028fc2b63/documents/83737ead-58ea-48c0-871e-21bf78f4e255_4d2157ba-d13a-44b0-a6f5-04c60edf1275.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Carbonohydrazide,497-18-7,"Acute oral toxicity: Based on the existing studies,  the LD50 is considered to be between 326 and 2000 mg/kg bodyweight. Acute dermal toxicity (Sanders, 2012): The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3121d563-eaa4-4fd6-baa2-3ae028fc2b63/documents/453f965c-5903-471f-a6a3-d806e8403cb4_4d2157ba-d13a-44b0-a6f5-04c60edf1275.html,,,,,, Carbonohydrazide,497-18-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3121d563-eaa4-4fd6-baa2-3ae028fc2b63/documents/453f965c-5903-471f-a6a3-d806e8403cb4_4d2157ba-d13a-44b0-a6f5-04c60edf1275.html,,oral,LD50,> 326 mg/kg bw,adverse effect observed, Carbonohydrazide,497-18-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3121d563-eaa4-4fd6-baa2-3ae028fc2b63/documents/453f965c-5903-471f-a6a3-d806e8403cb4_4d2157ba-d13a-44b0-a6f5-04c60edf1275.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Carbonyl difluoride,353-50-4," The results of a reliable study showed a 4-hour LC50 around 34.3 ppm. The result was supported by results of other less documented studies indicating that the 4-hour LC50 is below 100 ppm, and the 1-hour LC50 is approx 360 ppm. Analytical information indicated negligible formation of hydrogen fluoride under the conditions of the study. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e912d7a-836c-4ea3-854f-ce6e550e5527/documents/1bf14d86-933e-4878-84a7-0ffec6c530fc_76aa7619-b5d2-406e-9eea-f3ad3cc8caab.html,,,,,, Carbonyl difluoride,353-50-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e912d7a-836c-4ea3-854f-ce6e550e5527/documents/1bf14d86-933e-4878-84a7-0ffec6c530fc_76aa7619-b5d2-406e-9eea-f3ad3cc8caab.html,,inhalation,LC50,92.4 mg/m3,adverse effect observed, "Carbonyl(pentane-2,4-dionato-O,O')(triphenylphosphine)rhodium",25470-96-6," The acute median lethal oral dose (LD50) to rats of Carbonyl(pentane-2,4-dionato-O,O’) (triphenylphosphine)rhodium was demonstrated to be greater than 2000 mg/kg body weight. The substance does not need to a classification for acute toxicity under EU CLP. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4836c1b7-6af3-46ed-9fb2-335dde59c671/documents/457364ab-5f42-4f9d-b5c8-a57e6d0866cb_845e5e67-41f6-4d12-ae76-6859bfb68643.html,,,,,, "Carbonyl(pentane-2,4-dionato-O,O')(triphenylphosphine)rhodium",25470-96-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4836c1b7-6af3-46ed-9fb2-335dde59c671/documents/457364ab-5f42-4f9d-b5c8-a57e6d0866cb_845e5e67-41f6-4d12-ae76-6859bfb68643.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Carbonylhydrotris(triphenylphosphine)rhodium,17185-29-4,"In a guideline study, to GLP, the acute oral LD50 of carbonylhydridotris(triphenylphosphane)-rhodium(I) in rats was established to be above 2000 mg/kg bw (Berthold, 1991a).No relevant acute dermal or inhalation toxicity data were identified, or are required at this tonnage. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a394700-5655-4600-bb96-d6053467d6b2/documents/IUC5-71095a31-ed5c-4db8-a07e-7409ba249cbc_4cf49103-ae86-416e-8b7b-bd38b4740d2d.html,,,,,, Carbonylhydrotris(triphenylphosphine)rhodium,17185-29-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a394700-5655-4600-bb96-d6053467d6b2/documents/IUC5-71095a31-ed5c-4db8-a07e-7409ba249cbc_4cf49103-ae86-416e-8b7b-bd38b4740d2d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Carboxylic acids, C5-9",68603-84-9,"Valid dermal and inhalation studies are not available.Systemic toxicity is low, as evidenced by NOAEL values up to 5000 mg expressed of octanoic or decanoic acid. These data were obtained in oral studies using triglycerides instead of the free acid. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f4bb9f7-705d-4827-b229-ca5994a4ba79/documents/72371fc9-66e3-45a4-b2fd-1983aabf81e0_dec6d1d5-9c0d-4927-bd28-74e0184f2efb.html,,,,,, "Carboxylic acids, C5-9",68603-84-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f4bb9f7-705d-4827-b229-ca5994a4ba79/documents/72371fc9-66e3-45a4-b2fd-1983aabf81e0_dec6d1d5-9c0d-4927-bd28-74e0184f2efb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,000 mg/kg bw/day",,rat "Carboxylic acids, C5-9",68603-84-9," A recent GLP study carried out according to OECD 423 is available. According to this study the substance has a LD50 > 2000 mg/kg bw and being corrosive to the skin according to the studies carried out following the OECD guidelines 431 and 435, the other two routes are waived. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f4bb9f7-705d-4827-b229-ca5994a4ba79/documents/1e2c0a2c-2900-4a19-96e6-61f94e549ad5_dec6d1d5-9c0d-4927-bd28-74e0184f2efb.html,,,,,, "Carboxylic acids, C5-9",68603-84-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f4bb9f7-705d-4827-b229-ca5994a4ba79/documents/1e2c0a2c-2900-4a19-96e6-61f94e549ad5_dec6d1d5-9c0d-4927-bd28-74e0184f2efb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Carboxylic acids, di-, C4-6",68603-87-2,The NOAEL of AGS-Mixture in the 13-week study in rats was 3%. In this study the test item was dissolved in deionised water and the animals were dosed by gavage. The following parameters have to be taken into account to derive a NOAEL in mg/kg-bw: - AGS-Mixture contains overall 29% acids (adipic acid: 3.9%; Glutaric acid: 16.43%; succinic acid 4.77% and nitric acid 3.9%) - Volume applied per gavage per day: 10 ml/kg bw/day - NOAEL = 3% (w/w) x 10 ml/kg bw x 29% (w/w) = 87 mg/kg bw/d ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4cc872a2-373e-4560-a589-2de5d2ea87d2/documents/IUC5-5b98df04-7f99-4c91-8ee7-e43a4a6149bb_ab2cbb51-e388-45b8-99ea-3721db836af7.html,,,,,, "Carboxylic acids, di-, C4-6",68603-87-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4cc872a2-373e-4560-a589-2de5d2ea87d2/documents/IUC5-5b98df04-7f99-4c91-8ee7-e43a4a6149bb_ab2cbb51-e388-45b8-99ea-3721db836af7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,87 mg/kg bw/day,,rat "Carboxylic acids, di-, C4-6",68603-87-2, Dicarboxylic acid mixture is of low acute toxicity after oral or dermal exposure. Although no reliable inhalation study is available low toxicity by inhalation is also anticipated based on low acute toxicity data reported for adipic acid. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4cc872a2-373e-4560-a589-2de5d2ea87d2/documents/IUC5-fe20bc35-6e44-4b2e-9b4e-17c3441df842_ab2cbb51-e388-45b8-99ea-3721db836af7.html,,,,,, "Carboxylic acids, di-, C4-6",68603-87-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4cc872a2-373e-4560-a589-2de5d2ea87d2/documents/IUC5-fe20bc35-6e44-4b2e-9b4e-17c3441df842_ab2cbb51-e388-45b8-99ea-3721db836af7.html,,oral,LD50,"6,000 mg/kg bw",, "Carboxylic acids, di-, C4-6",68603-87-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4cc872a2-373e-4560-a589-2de5d2ea87d2/documents/IUC5-fe20bc35-6e44-4b2e-9b4e-17c3441df842_ab2cbb51-e388-45b8-99ea-3721db836af7.html,,dermal,LD50,"7,940 mg/kg bw",, "Carboxymethyldimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulphonyl]amino]propylammonium hydroxide",34455-29-3,"Oral: OECD 407; rats. NOEL: 40 mg/kg, based on test substance-related effects of soft stool, decreases in bodyweight, and/or liver changes at ≥200 mg/kg, which were all considered reversible. Reliability = 1Oral: OECD 408; rats. NOEL:1000 mg/kg/day based on a lack of adverse findings at any dose level. Specifically, there were no adverse findings in mortality, clinical observations, body weights, body weight gains, food consumption, neurobehavioral assessments, motor activity, ophthalmology, hematology, coagulation, clinical chemistry, urinalysis, thyroid hormones, organ weights, macroscopic observations, or microscopic observations. Non-adverse findings included observations in the lung and mesenteric lymph nodes suggestive of phospholipidosis and nasal cavity findings consistent with gastric reflux. There were non-adverse reductions in cholesterol at all dose levels in the male rats.  These findings were not dose-responsive, or only weakly so, and were not associated with any microscopic changes. While these findings are test-substance related they were considered non-adverse. Reliability = 1   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/675b47cc-b030-4198-bc17-a4ba6aaa7e21/documents/IUC5-f38e5bce-a5f0-43fe-994f-a0da1264b2e0_4e1f5996-e9fb-4f13-81fd-a7cbc8948cbf.html,,,,,, "Carboxymethyldimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulphonyl]amino]propylammonium hydroxide",34455-29-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/675b47cc-b030-4198-bc17-a4ba6aaa7e21/documents/IUC5-f38e5bce-a5f0-43fe-994f-a0da1264b2e0_4e1f5996-e9fb-4f13-81fd-a7cbc8948cbf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Carboxymethyldimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulphonyl]amino]propylammonium hydroxide",34455-29-3,Oral: OECD 425; rat LC50 >5000 mg/kg. Reliability = 1Dermal: OECD 402; rat LC50 >5000 mg/kg. Reliability = 1 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/675b47cc-b030-4198-bc17-a4ba6aaa7e21/documents/IUC5-2c2fbedd-f74c-4007-be98-9bfe98bcad45_4e1f5996-e9fb-4f13-81fd-a7cbc8948cbf.html,,,,,, "Carboxymethyldimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulphonyl]amino]propylammonium hydroxide",34455-29-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/675b47cc-b030-4198-bc17-a4ba6aaa7e21/documents/IUC5-2c2fbedd-f74c-4007-be98-9bfe98bcad45_4e1f5996-e9fb-4f13-81fd-a7cbc8948cbf.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Carboxymethyldimethyl-3-[[(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)sulphonyl]amino]propylammonium hydroxide",34455-29-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/675b47cc-b030-4198-bc17-a4ba6aaa7e21/documents/IUC5-2c2fbedd-f74c-4007-be98-9bfe98bcad45_4e1f5996-e9fb-4f13-81fd-a7cbc8948cbf.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Cashew, nutshell liq., oligomeric reaction products with 1-chloro-2,3-epoxypropane",68413-24-1,"1) OECD 408 NOAEL (rat): 62.5 mg/kg bw/day (nominal) [GLP; test material ‘Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled, oligomerisation products with 1-chloro-2,3-epoxypropane’ (EC/List no. 701-477-4)] 2) OECD 422 NOAEL (rat): 250 mg/kg bw/day (nominal) [GLP; test material ‘Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled, oligomerisation products with 1-chloro-2,3-epoxypropane’ (EC/List no. 701-477-4)] ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36badfeb-fdeb-4848-8976-1368b05dc78c/documents/946db965-09dc-4eac-9efc-3177b4101ab8_4035232f-dde2-45ce-8ea5-994f2fd6d1b1.html,,,,,, "Cashew, nutshell liq., oligomeric reaction products with 1-chloro-2,3-epoxypropane",68413-24-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36badfeb-fdeb-4848-8976-1368b05dc78c/documents/946db965-09dc-4eac-9efc-3177b4101ab8_4035232f-dde2-45ce-8ea5-994f2fd6d1b1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,62.5 mg/kg bw/day,,rat "Cashew, nutshell liq., oligomeric reaction products with 1-chloro-2,3-epoxypropane",68413-24-1,"- Acute oral toxicity [OECD 423, acute toxic class method; GLP; test material ‘Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled, oligomerisation products with 1-chloro-2,3-epoxypropane’ (EC/List no. 701-477-4)]: LD50 in female rats >2000 mg/kg bw. - Acute inhalation toxicity: Taking into account the very low vapour pressure of the registration substance, exposure via the inhalation route is unlikely; it is therefore considered justified to omit this endpoint information. - Acute dermal toxicity [OECD 402, standard acute method; GLP; test material ‘Cashew (Anacardium occidentale) Nutshell Extract, Decarboxylated, Distilled, oligomerisation products with 1-chloro-2,3-epoxypropane’ (EC/List no. 701-477-4)]: LD50 in male/female rats >2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36badfeb-fdeb-4848-8976-1368b05dc78c/documents/07dd1307-56a2-4e4a-826a-1a72eb28bc22_4035232f-dde2-45ce-8ea5-994f2fd6d1b1.html,,,,,, "Cashew, nutshell liq., oligomeric reaction products with 1-chloro-2,3-epoxypropane",68413-24-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36badfeb-fdeb-4848-8976-1368b05dc78c/documents/07dd1307-56a2-4e4a-826a-1a72eb28bc22_4035232f-dde2-45ce-8ea5-994f2fd6d1b1.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Cashew, nutshell liq., oligomeric reaction products with 1-chloro-2,3-epoxypropane",68413-24-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36badfeb-fdeb-4848-8976-1368b05dc78c/documents/07dd1307-56a2-4e4a-826a-1a72eb28bc22_4035232f-dde2-45ce-8ea5-994f2fd6d1b1.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Castor oil, dehydrated",64147-40-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/541797b7-51a1-4d73-ab09-ea12979e9981/documents/IUC5-18734173-6d0e-4fd1-b663-c8b63b1cb6fb_7100fd0c-1919-4804-a958-faa02b55d4ff.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"9,500 mg/kg bw/day",,rat "Castor oil, dehydrated",64147-40-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/541797b7-51a1-4d73-ab09-ea12979e9981/documents/IUC5-76732865-bf6f-4400-a3ec-7100ee8c9994_7100fd0c-1919-4804-a958-faa02b55d4ff.html,,oral,LD50,"4,763 mg/kg bw",no adverse effect observed, "Castor oil, dehydrated",64147-40-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/541797b7-51a1-4d73-ab09-ea12979e9981/documents/IUC5-76732865-bf6f-4400-a3ec-7100ee8c9994_7100fd0c-1919-4804-a958-faa02b55d4ff.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, "Castor oil, ester with glycerol",68459-67-6," In the absence of repeated dose toxicity data on target substance Castor oil, ester with glycerol an analogue read-across approach was conducted on suitable source substances: Oral, mouse (OECD 408): NOAEL systemic (male) ≥ 15017 mg/kg bw/day; NOAEL systemic (female) ≥ 16786 mg/kg bw/day Oral, rat (OECD 408): NOAEL systemic (male) ≥ 5835 mg/kg bw/day; NOAEL systemic (female) ≥ 5725 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e81f8556-faf4-458e-bbec-4500989f8c64/documents/08da55cf-287e-419a-b677-0320df728d31_1a9ceda7-6342-460d-b2b2-4360ff5b20ba.html,,,,,, "Castor oil, ester with glycerol",68459-67-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e81f8556-faf4-458e-bbec-4500989f8c64/documents/08da55cf-287e-419a-b677-0320df728d31_1a9ceda7-6342-460d-b2b2-4360ff5b20ba.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"5,725 mg/kg bw/day",,rat "Castor oil, ester with glycerol",68459-67-6," Oral (OECD 401), mouse: LD50 > 2000 mg/kg bw In the absence of data on acute dermal toxicity of Castor oil, ester with glycerol an analogue read-across approach was conducted on CAS 555 -43 -1: Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e81f8556-faf4-458e-bbec-4500989f8c64/documents/fc394b9c-dc71-4cd1-91df-80d7ecf6d580_1a9ceda7-6342-460d-b2b2-4360ff5b20ba.html,,,,,, "Castor oil, ester with sorbitol",97488-70-5," Acute oral toxicity: Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Castor oil, ester with sorbitol (CAS no.: 97488-70-5). The studies are as mentioned below: 1. Acute Oral toxicity study was conducted by using test chemical in 20 fasted rats at oral dose 39.8 g/kg as a 90% w/v concentration in corn oil. Animals were observed for mortality for 14 days. No mortality was observed at 39800 mg/kg bw. Therefore, LD50 was considered to be >39800 mg/kg bw, when 20 male and female rats were treated with test chemical via oral route.  2. Acute Oral toxicity study was conducted by using test chemical in 10 Sprague-Dawley rats at oral dose 20.0 g/kg bw. Animals were observed for mortality for 14 days. Necropsy was performed. No mortality was observed at 20000 mg/kg bw. At necropsy, none of the animals had gross lesions. Therefore, LD50 was considered to be >20000 mg/kg bw, when 10 male and female Sprague-Dawley rats were treated with test chemical via oral route. Thus, based on the above summarised studies, Castor oil, ester with sorbitol (CAS no.: 97488-70-5) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Castor oil, ester with sorbitol (CAS no.: 97488-70-5) cannot be classified for acute oral toxicity. Hence, based on the data available for the structurally similar read across chemical, Castor oil, ester with sorbitol is not likely to be toxic in the dose range of >20000 - >39800 mg/Kg bw. Acute Dermal Toxicity: Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute dermal toxicity of the test chemical Castor oil, ester with sorbitol (CAS no.: 97488-70-5). The studies are as mentioned below: 1. Acute Dermal toxicity study was conducted by using test chemical in 8 male and female albino rabbits at dose of 6800 mg/kg and 10200 mg/kg bw. 2 groups of 2 male and 2 female albino rabbits received a 24-hour patch test of a cosmetic cleansing cream containing 3% test chemical. One group received the undiluted product in a dose of 6.8 g/kg; the other, 10.2 g/kg. Animals were observed for mortality and clinical signs for 14 days. No mortality was observed at 10200 mg/kg bw. Abnormal behavior, adverse body weight changes, or gross alterations were noted during the 14-day observation period. At the end of the 24-hour contact period, definite red, well-defined erythema was observed at the contact site on each animal. The erythema subsided by Day 7. Therefore, LD50 was considered to be >10200 mg/kg bw, when 8 male and female albino rabbits were treated with test chemical by dermal application.  2. The study was designed and conducted to determine the acute dermal toxicity profile of test chemical in Sprague Dawley rats. The test item was applied to shorn skin of 5 male and 5 female animals at 2000 mg/kg body weight. Administration of the test item at 2000 mg/kg did not result in any skin reaction at the site of application during the study period of 14 days. Administration of the test item did not result in any signs of toxicity and mortality during the study period of 14 days. Animals exhibited normal body weight gain through the study period of 14 days. Gross pathological examination did not reveal any abnormalities attributable to the treatment. It was concluded that the acute dermal median lethal dose (LD50) of test chemical, when administered to male and female Sprague Dawley rats was found to be >2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that given test chemical does not classify as an acute dermal toxicant.  CLP Classification: “Not classified”. Thus, based on the above summarised studies, Castor oil, ester with sorbitol (CAS no.: 97488-70-5) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Castor oil, ester with sorbitol (CAS no.: 97488-70-5) cannot be classified for acute dermal toxicity. Hence, based on the data available for the structurally similar read across chemical, Castor oil, ester with sorbitol is not likely to be toxic in the dose range of >2000 - >10200 mg/Kg bw for acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9edbced6-4b38-4bf0-b9a6-d452f45c8ba2/documents/30330251-2dcf-45a1-b202-583a2a2656fc_158369d7-b4f7-4cca-9860-5c3fcbefc663.html,,,,,, "Castor oil, ester with sorbitol",97488-70-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9edbced6-4b38-4bf0-b9a6-d452f45c8ba2/documents/30330251-2dcf-45a1-b202-583a2a2656fc_158369d7-b4f7-4cca-9860-5c3fcbefc663.html,,oral,LD50,"39,800 mg/kg bw",no adverse effect observed, "Castor oil, ester with sorbitol",97488-70-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9edbced6-4b38-4bf0-b9a6-d452f45c8ba2/documents/30330251-2dcf-45a1-b202-583a2a2656fc_158369d7-b4f7-4cca-9860-5c3fcbefc663.html,,dermal,LD50,"10,200 mg/kg bw",no adverse effect observed, "Castor oil, hydrogenated, lithium salt",64754-95-6,"Dose responsive localized dermal effects at the test site (dorsal surface), consisting of scabbed post dose findings and elevated dermal scores. These findings were most pronounced at 1000 mg/kg/day and were seen most frequently at this dose level. The findings at 300 mg/kg/day were at a lower incidence and with lower dermal scores. Dermal scores and findings at 100 mg/kg/day were comparable to the controls. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/edcdf2be-365c-461e-83eb-8c9e69568ad5/documents/IUC5-cf1f20d6-ead5-4b11-999a-27adbc87afc9_ca4cad54-f4af-4a71-b4e1-79f95bf30a40.html,,,,,, "Castor oil, hydrogenated, lithium salt",64754-95-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/edcdf2be-365c-461e-83eb-8c9e69568ad5/documents/IUC5-cf1f20d6-ead5-4b11-999a-27adbc87afc9_ca4cad54-f4af-4a71-b4e1-79f95bf30a40.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,089.75 mg/kg bw/day",,rat "Castor oil, hydrogenated, lithium salt",64754-95-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/edcdf2be-365c-461e-83eb-8c9e69568ad5/documents/IUC5-cf1f20d6-ead5-4b11-999a-27adbc87afc9_ca4cad54-f4af-4a71-b4e1-79f95bf30a40.html,Chronic toxicity – systemic effects,oral,NOAEL,41 mg/kg bw/day,,other:Human data "Castor oil, hydrogenated, lithium salt",64754-95-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/edcdf2be-365c-461e-83eb-8c9e69568ad5/documents/IUC5-cf1f20d6-ead5-4b11-999a-27adbc87afc9_ca4cad54-f4af-4a71-b4e1-79f95bf30a40.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.86 mg/cm2,adverse effect observed,rat "Castor oil, hydrogenated, lithium salt",64754-95-6,It is considered from the results that all the substances in the category of lithium salts of C14-C22 monocarboxylic acids exhibit a similar lack of acute oral and dermal toxicity potential across the entire category. There is no evidence of a relevant intrinsic acute oral or dermal toxicity requiring classification or substance specific RMMs. An estimate of the inhalative dust/mist toxicity by route-to-route extrapolation result in an ATE well above the cut-off values for classification for acute inhalation toxicity hazard. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edcdf2be-365c-461e-83eb-8c9e69568ad5/documents/IUC5-350f02aa-ccb3-4e1a-980c-f2ee942891af_ca4cad54-f4af-4a71-b4e1-79f95bf30a40.html,,,,,, "Castor oil, hydrogenated, lithium salt",64754-95-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edcdf2be-365c-461e-83eb-8c9e69568ad5/documents/IUC5-350f02aa-ccb3-4e1a-980c-f2ee942891af_ca4cad54-f4af-4a71-b4e1-79f95bf30a40.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Castor oil, hydrogenated, lithium salt",64754-95-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edcdf2be-365c-461e-83eb-8c9e69568ad5/documents/IUC5-350f02aa-ccb3-4e1a-980c-f2ee942891af_ca4cad54-f4af-4a71-b4e1-79f95bf30a40.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Castor oil, oxidized",68187-84-8,"Two studies with read across substances Blown linseed oil and Blown rapeseed oil, in accordance with OECD 422, showing no evidence of toxicity (NOAEL: >1000 mg/kg bw/day). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a277c58f-b15e-400d-afd4-4732174a86c4/documents/IUC5-82cfa6b4-92c4-4939-a481-6bf48d743ec7_f94bacd8-95fd-4616-accb-7c16e26b553f.html,,,,,, "Castor oil, oxidized",68187-84-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a277c58f-b15e-400d-afd4-4732174a86c4/documents/IUC5-82cfa6b4-92c4-4939-a481-6bf48d743ec7_f94bacd8-95fd-4616-accb-7c16e26b553f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Castor oil, oxidized",68187-84-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): One reliable experimental oral acute toxicity study with rats according to OECD 420 and under GLP conditions is available, resulting in sufficient quality to assess this endpoint. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The acute toxicity study by the inhalation route is waived n accordance with column 2 of REACH Annex VIII, as significant exposure of humans via inhalation is unlikely taking into account the vapour pressure of the substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a277c58f-b15e-400d-afd4-4732174a86c4/documents/IUC5-4e27118f-44c2-4b5c-9ead-1897168366a3_f94bacd8-95fd-4616-accb-7c16e26b553f.html,,,,,, "Castor oil, oxidized",68187-84-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a277c58f-b15e-400d-afd4-4732174a86c4/documents/IUC5-4e27118f-44c2-4b5c-9ead-1897168366a3_f94bacd8-95fd-4616-accb-7c16e26b553f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Castor oil, sulfated, ammonium salt",68187-77-9," NOAEL oral, rat, female (OECD 422) = 1000 mg/Kg bw day NOAEL oral, rat, male (OECD 422) = 300 mg/kg bw /day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4162809c-08ae-4618-9a8e-0799f3fdeeec/documents/d6d06cfa-a333-4061-b56b-f3994983045a_548dcd44-b6de-4e64-ae65-260d099be7a5.html,,,,,, "Castor oil, sulfated, ammonium salt",68187-77-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4162809c-08ae-4618-9a8e-0799f3fdeeec/documents/d6d06cfa-a333-4061-b56b-f3994983045a_548dcd44-b6de-4e64-ae65-260d099be7a5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Castor oil, sulfated, ammonium salt",68187-77-9," analogue substance 1 LD50 . oral > 15600 mg/kg FLL sample 4, limit test, LD50 oral > 2000 mg/kg FLL sample 4, LD50, dermal > 2000 mg/kg acute toxicity inhalation: not relevant ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4162809c-08ae-4618-9a8e-0799f3fdeeec/documents/74b0b956-be28-43d8-9feb-6ac0aa5ab796_548dcd44-b6de-4e64-ae65-260d099be7a5.html,,,,,, "Castor oil, sulfated, ammonium salt",68187-77-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4162809c-08ae-4618-9a8e-0799f3fdeeec/documents/74b0b956-be28-43d8-9feb-6ac0aa5ab796_548dcd44-b6de-4e64-ae65-260d099be7a5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Castor oil, sulfated, ammonium salt",68187-77-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4162809c-08ae-4618-9a8e-0799f3fdeeec/documents/74b0b956-be28-43d8-9feb-6ac0aa5ab796_548dcd44-b6de-4e64-ae65-260d099be7a5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Castor oil, sulfated, sodium salt",68187-76-8, NOAEL rat (90d) = 450 mg/Kg/day (test item) NOAEL rat (90d)= 288 mg/kg/day (active substance 62 -64%)) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f95ac824-c51a-43c2-b37b-c2bada095556/documents/IUC5-46b42751-2091-4773-9084-8422d7bb0867_8fdd973d-54ea-41f1-8d76-dbafbd2f9418.html,,,,,, "Castor oil, sulfated, sodium salt",68187-76-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f95ac824-c51a-43c2-b37b-c2bada095556/documents/IUC5-46b42751-2091-4773-9084-8422d7bb0867_8fdd973d-54ea-41f1-8d76-dbafbd2f9418.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,288 mg/kg bw/day,,rat "Castor oil, sulfated, sodium salt",68187-76-8," LD50 . oral > 15600 mg/kg FLL sample 4, limit test, LD50 oral > 2000 mg/kg FLL sample 4, LD50, dermal > 2000 mg/kg acute toxicity inhalation: not relevant The more conservative 2000 mg/kg bw no effect levels from the more extensive read across studies was used as the starting point to derive DNELs for the sulfated fat liquors. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f95ac824-c51a-43c2-b37b-c2bada095556/documents/IUC5-e98ae109-f221-4c3c-b2a1-47c0980e7ba6_8fdd973d-54ea-41f1-8d76-dbafbd2f9418.html,,,,,, "Castor oil, sulfated, sodium salt",68187-76-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f95ac824-c51a-43c2-b37b-c2bada095556/documents/IUC5-e98ae109-f221-4c3c-b2a1-47c0980e7ba6_8fdd973d-54ea-41f1-8d76-dbafbd2f9418.html,,oral,LD50,"15,600 mg/kg bw",no adverse effect observed, "Castor oil, sulfated, sodium salt",68187-76-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f95ac824-c51a-43c2-b37b-c2bada095556/documents/IUC5-e98ae109-f221-4c3c-b2a1-47c0980e7ba6_8fdd973d-54ea-41f1-8d76-dbafbd2f9418.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Cement copper,67711-88-0,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d347b9c-3551-43ac-8615-2091833b3849/documents/ac0cc3eb-e21a-4f30-8afc-af81572a03a0_80d010fa-410a-47cc-897b-0eb727656264.html,,,,,, Cement copper,67711-88-0,The acute toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d347b9c-3551-43ac-8615-2091833b3849/documents/c9d9712f-4e46-4d4c-993a-e527e6f921e2_80d010fa-410a-47cc-897b-0eb727656264.html,,,,,, "Cement, alumina, chemicals",65997-16-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d37cf3e0-14c6-4115-b9e0-4ab6ba0bea8a/documents/IUC5-e2d73cdd-12ec-411c-94ac-716fb5404a18_4654f994-5ff6-4ce0-8e61-f601bba4fdd0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Cement, alumina, chemicals",65997-16-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d37cf3e0-14c6-4115-b9e0-4ab6ba0bea8a/documents/IUC5-e2d73cdd-12ec-411c-94ac-716fb5404a18_4654f994-5ff6-4ce0-8e61-f601bba4fdd0.html,Chronic toxicity – systemic effects,inhalation,NOAEC,2.5 mg/m3,, "Cement, alumina, chemicals",65997-16-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d37cf3e0-14c6-4115-b9e0-4ab6ba0bea8a/documents/IUC5-46f8dac8-24b4-4012-add6-0dd92dbfeff4_4654f994-5ff6-4ce0-8e61-f601bba4fdd0.html,,oral,LD50,"2,000 mg/kg bw",, "Cement, alumina, chemicals",65997-16-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d37cf3e0-14c6-4115-b9e0-4ab6ba0bea8a/documents/IUC5-46f8dac8-24b4-4012-add6-0dd92dbfeff4_4654f994-5ff6-4ce0-8e61-f601bba4fdd0.html,,dermal,LD50,"2,000 mg/kg bw",, "Cement, alumina, chemicals",65997-16-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d37cf3e0-14c6-4115-b9e0-4ab6ba0bea8a/documents/IUC5-46f8dac8-24b4-4012-add6-0dd92dbfeff4_4654f994-5ff6-4ce0-8e61-f601bba4fdd0.html,,inhalation,discriminating conc.,2.5 mg/m3,, Cerium,7440-45-1,"Repeated dose toxicity oral - NOAEL (subacute, rat): 150 mg/kg bw/dayRepeated dose toxicity inhalation - NOAEC (subchronic, rat): 5 mg/m³ ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b27d1cdf-1309-4f8b-a582-aea717ddfff2/documents/156d6147-6a51-4c1e-9932-dcc6768e7296_90d3d292-397c-49e8-8f42-994baf9d31b9.html,,,,,, Cerium,7440-45-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b27d1cdf-1309-4f8b-a582-aea717ddfff2/documents/156d6147-6a51-4c1e-9932-dcc6768e7296_90d3d292-397c-49e8-8f42-994baf9d31b9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Cerium,7440-45-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b27d1cdf-1309-4f8b-a582-aea717ddfff2/documents/156d6147-6a51-4c1e-9932-dcc6768e7296_90d3d292-397c-49e8-8f42-994baf9d31b9.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,5 mg/m3,,rat Cerium,7440-45-1,"Acute oral tox: The oral LD50 in male/female Sprague-Dawley rats was established to be > 5000 mg/kg bw based on the results of a key study conducted similar to EPA OPPTS 870.1100 (K2; Lamb, 1993) and a supporting study that meets the general accepted scientific principles (K2; Kawagoe, 2008).   Acute inhalation tox: The inhalation LC50 in male/female Wistar rats was established to be > 5.05 mg/L (4 hours) based on the results af a key study conducted according to OECD guideline 403 (K1; Duchosal, 1993).    Acute dermal toxicity: No acute dermal toxicity study is available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b27d1cdf-1309-4f8b-a582-aea717ddfff2/documents/771d231e-e474-4506-95ff-c6f635df7ba7_90d3d292-397c-49e8-8f42-994baf9d31b9.html,,,,,, Cerium,7440-45-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b27d1cdf-1309-4f8b-a582-aea717ddfff2/documents/771d231e-e474-4506-95ff-c6f635df7ba7_90d3d292-397c-49e8-8f42-994baf9d31b9.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Cerium,7440-45-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b27d1cdf-1309-4f8b-a582-aea717ddfff2/documents/771d231e-e474-4506-95ff-c6f635df7ba7_90d3d292-397c-49e8-8f42-994baf9d31b9.html,,inhalation,LC50,5.05 mg/m3,no adverse effect observed, Cerium tetranitrate,13093-17-9,"Acute oral toxicity: The oral LD50 in female Wistar rats was estimated to be greater than 2248 mg/kg bw (equivalent to 2000 mg active ingredient/kg bodyweight) in a study conducted according to OECD Guideline 420 and EU Method B.1 bis (Bradshaw, 2013). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aee80a40-bfbf-4179-b849-a698a5800295/documents/IUC5-ae2f4682-fccd-47d0-8e69-530f928f2767_442b963d-4a66-4bf5-b3db-2a8c7afeb085.html,,,,,, Cerium trichloride,7790-86-5,Repeated dose toxicity: oralBraun (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test in rats according to OECD guideline 422 (GLP) with the read-across substance cerium trinitrate. A NOAEL for systemic toxicity of 330 mg/kg bw/day was derived. The read-across justification is added in Section 13 of IUCLID. A maximal reliability score of 2 (reliable with restrictions) has been assigned because the study is used for read across purposes in this dossier. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1866e2fd-f205-436d-8e1a-020ef6250784/documents/IUC5-0d49279e-a024-413b-9336-07417c3bdebe_8edd4d3e-10b3-4559-9934-a9819d91dc22.html,,,,,, Cerium trichloride,7790-86-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1866e2fd-f205-436d-8e1a-020ef6250784/documents/IUC5-0d49279e-a024-413b-9336-07417c3bdebe_8edd4d3e-10b3-4559-9934-a9819d91dc22.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,330 mg/kg bw/day,,rat Cerium trichloride,7790-86-5,"Acute toxicity: oralA K1 acute oral toxicity test was performed in male and female Sprague-Dawley rats according to a guideline similar to OECD Guideline 401 and according to the Code of Federal Regulations 16:1500.3 (Shapiro R, 1991). The LD50 was estimated to be 2800 mg/kg bw. This study was selected as key study.Acute toxicity: inhalationAn acute inhalation study does not need to be conducted as the substance is classified as corrosive to the skin. In addition the substance appears asa clump and is produced as a solution. Therefore formation of respirable suspended particulate matter is unlikely.Acute toxicity: dermalAn acute dermal study does not need to be conducted as the substance is classified as corrosive to the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1866e2fd-f205-436d-8e1a-020ef6250784/documents/IUC5-c1546338-445a-4c63-b1d8-a94d0764faef_8edd4d3e-10b3-4559-9934-a9819d91dc22.html,,,,,, Cerium trichloride,7790-86-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1866e2fd-f205-436d-8e1a-020ef6250784/documents/IUC5-c1546338-445a-4c63-b1d8-a94d0764faef_8edd4d3e-10b3-4559-9934-a9819d91dc22.html,,oral,LD50,"2,800 mg/kg bw",no adverse effect observed, Cerium trifluoride,7758-88-5,"Oral (28-day): Male/female NOEL 1000 mg/kg bw, female; OECD 422, Charles River (2013) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74c9087f-c3f2-4a30-a8c7-16f21be90d59/documents/IUC5-3329e19d-04dc-4850-b381-6b5f13bd8221_b6abbab1-b0c5-49cb-b7c8-542f97f285b6.html,,,,,, Cerium trifluoride,7758-88-5,ACUTE TOXICITY: VIA THE ORAL ROUTEThe key study reports an LD0 in the rat of ≥2000 mg/kg bodyweight. Both supporting studies report an LD50 in the rat of >5000 mg/kg bodyweight. ACUTE TOXICITY: VIA INHALATION ROUTEThe 4 hour LC50 in the rat was >5.53 mg/L.ACUTE TOXICITY: VIA DERMAL ROUTEThis study was waived on the basis that the oral and inhalation routes of administration were considered more relevant when considering the physical nature and use pattern of the substance. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74c9087f-c3f2-4a30-a8c7-16f21be90d59/documents/IUC5-6ff10cb5-597e-4392-9eb5-aa7e339417df_b6abbab1-b0c5-49cb-b7c8-542f97f285b6.html,,,,,, Cerium trinitrate,10108-73-3," Repeated dose toxicity - oral: Braun (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test in rats according to OECD guideline 422 (GLP). Based on the results of this study, a NOAEL value of 330 mg/kg bw/day was established. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. In addition, and due to the special properties of the substance, it appears as a clump and formation of respirable suspended particulate matter is unlikely. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1eaff088-1674-45c9-9ba4-e4f48c0cc799/documents/IUC5-ac3d4db3-296a-43c9-b8cf-d3555ce3101f_5673e624-9bef-44b8-9fc0-f8410bfdfefd.html,,,,,, Cerium trinitrate,10108-73-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1eaff088-1674-45c9-9ba4-e4f48c0cc799/documents/IUC5-ac3d4db3-296a-43c9-b8cf-d3555ce3101f_5673e624-9bef-44b8-9fc0-f8410bfdfefd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,330 mg/kg bw/day,,rat Cerium trinitrate,10108-73-3,"Acute toxicity: oral:A K2 acute oral toxicity test was performed in female Sprague-Dawley rats according to a guideline similar to OECD Guideline 401 (Bruce DW, 1963) with cerium nitrate. This study was selected as key study. The LD50 was considered to be 4200 mg/kg bw Acute toxicity: inhalation: A key study is available for the oral and dermal route of exposure. According to the REACH Regulation, only one additional route of exposure should be tested other than the oral route of exposure for acute toxicity (column 2, annex VIII, section 8.5). Therefore, it is not necessary to perform an acute toxicity study via the inhalation route of exposure. In addition the substance appears as a clump and formation of respirable suspended particulate matter is unlikely.Acute toxicity: dermal:A K1 acute dermal toxicity test was performed in male and female Wistar rats according to OECD Guideline 402 and EC method B3 (Bradshaw, 2013). In this study, the LD50 was found to be > 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1eaff088-1674-45c9-9ba4-e4f48c0cc799/documents/IUC5-082ff70c-54e5-499d-945b-634562d31f20_5673e624-9bef-44b8-9fc0-f8410bfdfefd.html,,,,,, Cerium trinitrate,10108-73-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1eaff088-1674-45c9-9ba4-e4f48c0cc799/documents/IUC5-082ff70c-54e5-499d-945b-634562d31f20_5673e624-9bef-44b8-9fc0-f8410bfdfefd.html,,oral,LD50,"4,200 mg/kg bw",no adverse effect observed, Cerium(3+) acetate,537-00-8," Read-across performed with structurally similar substance The NOEL (No observed effect level) for systemic toxicity of the parent animals was considered to be 110 mg/kg/day, based upon the changes in the stomachs of rats treated with 330 mg/kg/day and 1000 mg/kg/day as well as differences in the mean daily food consumption/body weight development at 1000 mg/kg/day. Although these changes were considered to be related to the treatment with the test material, the morphological changes in the stomachs were considered to be local effects (irritation) rather than systemic toxicity and the differences in the food consumption/body weight were considered secondary to the changes in the stomach. However, as two animals treated with 1000 mg/kg/day died as a result of the stomach findings, the NOAEL (No Observed Adverse Effect Level) for systemic toxicity of the parent animals was considered to be 330 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5fafefe-64b5-4ddd-9d65-271fd8f8e64f/documents/ee23368d-4dd3-4d6f-8652-9f5127a93de3_cfe6cd90-fc8c-47c7-96f6-5894e541292b.html,,,,,, Cerium(3+) acetate,537-00-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5fafefe-64b5-4ddd-9d65-271fd8f8e64f/documents/ee23368d-4dd3-4d6f-8652-9f5127a93de3_cfe6cd90-fc8c-47c7-96f6-5894e541292b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,330 mg/kg bw/day,,rat Cerium(3+) acetate,537-00-8," Oral Under the conditions of the study, the acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5fafefe-64b5-4ddd-9d65-271fd8f8e64f/documents/76094d06-2bbd-429c-9e23-e1a2c5ab3666_cfe6cd90-fc8c-47c7-96f6-5894e541292b.html,,,,,, Cerium(3+) acetate,537-00-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5fafefe-64b5-4ddd-9d65-271fd8f8e64f/documents/76094d06-2bbd-429c-9e23-e1a2c5ab3666_cfe6cd90-fc8c-47c7-96f6-5894e541292b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Cerium(3+) neodecanoate,68084-49-1," No acute toxicity studies with cerium neodecanoate are available, thus the acute toxicity will be addressed with existing data on the dissociation products cerium and neodecanoate. Signs of acute oral toxicity are not expected for cerium neodecanoate, since the two moieties cerium and neodecanoic acid have not shown signs of acute oral toxicity in experimental testing (both LD50 > 2000mg/kg). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac85bcc1-9497-4cb1-9a7c-427a5b7a5647/documents/67dfb145-dc97-4fe9-b0c9-461cbeb88cde_d651f03d-63fc-49e4-99b4-11ceaed9d543.html,,,,,, Cerium(4+) disulphate,13590-82-4, As the test item is corrosive to the skin no acute toxicity study was conducted. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c5e7a9e-6e42-4fc4-90fa-cbaafe861089/documents/da282408-1a3e-4ea1-95d9-abf36d59878f_6440dc0b-80a2-4b51-8ae5-471ba39f2335.html,,,,,, Cesium acetate,3396-11-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed55c8c3-d2be-4b5f-9652-85974f2030f1/documents/f3502395-a3ff-48ac-8073-23bb1881e39f_1e1978c7-6bd4-40f5-9b74-30821d7f6e27.html,,oral,LD50,"1,550 mg/kg bw",adverse effect observed, Cesium bicarbonate,15519-28-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Three literature data are used for a weight of evidence approach. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13475eaf-9fa0-41b2-b223-4d22fb8a242e/documents/743153ca-520f-408f-931c-91f57625e118_03370429-ae04-4e22-b640-92ba2ece02e6.html,,,,,, Cesium bicarbonate,15519-28-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13475eaf-9fa0-41b2-b223-4d22fb8a242e/documents/743153ca-520f-408f-931c-91f57625e118_03370429-ae04-4e22-b640-92ba2ece02e6.html,,oral,LD50,"2,880 mg/kg bw",no adverse effect observed, Cesium formate,3495-36-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): High quality dataset ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/02983351-0aca-4a80-ae43-33bc5b5e47e9/documents/IUC5-5fa791ca-0971-4b57-b82f-e80d63e7bfe1_d7ee41dd-50ec-40a6-9948-364a4c62c957.html,,,,,, Cesium formate,3495-36-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/02983351-0aca-4a80-ae43-33bc5b5e47e9/documents/IUC5-5fa791ca-0971-4b57-b82f-e80d63e7bfe1_d7ee41dd-50ec-40a6-9948-364a4c62c957.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat Cesium formate,3495-36-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02983351-0aca-4a80-ae43-33bc5b5e47e9/documents/IUC5-59c6195c-9738-4359-a6ca-078c2c7237d7_d7ee41dd-50ec-40a6-9948-364a4c62c957.html,,oral,LD50,"1,780 mg/kg bw",adverse effect observed, Cesium formate,3495-36-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02983351-0aca-4a80-ae43-33bc5b5e47e9/documents/IUC5-59c6195c-9738-4359-a6ca-078c2c7237d7_d7ee41dd-50ec-40a6-9948-364a4c62c957.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, caesium(1+) tungsten(1+) oxidandiide,52350-17-1,"LD50 > 2000 mg/kg bw, OECD 423, Poole 2005 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2124b1e4-7639-4df7-a5dc-54080098261c/documents/0cf68e58-53c9-4528-abae-29cae0fdded6_bd83b8bb-7ac8-4cf8-9035-b9d251700b68.html,,,,,, caesium(1+) tungsten(1+) oxidandiide,52350-17-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2124b1e4-7639-4df7-a5dc-54080098261c/documents/0cf68e58-53c9-4528-abae-29cae0fdded6_bd83b8bb-7ac8-4cf8-9035-b9d251700b68.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Charcoal, coconut shell",68647-86-9,28-d repeated dose testing is not required as it is suggested to perform a long-term (90-d) repeated dose toxicity (with the Read-Across substance charcoal) instead. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/beee8986-4622-491d-847a-d367d3857fb9/documents/IUC5-5312c3ea-77cf-4d6d-a982-9bdeb3a92ba0_f1076f17-ec69-450a-889a-0be547250913.html,,,,,, "Charcoal, coconut shell",68647-86-9,"The acute inhalative toxicity of the Read-Across substance charcoal (Probe 2: C-Fix=80.5%) was investigated in a study in rats that was performed according to OECD guideline no. 403, EU method B.2 and the US EPA Health Effects Test guideline OPPTS 870.1300, Acute Inhalation Toxicity, as per August 1998.The acute oral toxicity of coconut shell charcoal was investigated in a study in rats that was performed according to OECD guideline no. 423. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/beee8986-4622-491d-847a-d367d3857fb9/documents/IUC5-ac579a0f-347a-4cec-b83c-b7a69491d8d5_f1076f17-ec69-450a-889a-0be547250913.html,,,,,, Chloramide,10599-90-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): OECD guideline 412 and GLP compliant Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): OECD guideline 412 and GLP compliant Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The key studies are similar to OECD test guideline (408) and are of medium quality (Klimish score = 2) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad020079-b19c-4570-b2ed-c6a1283a3331/documents/IUC5-841f8f6f-4f14-4deb-a153-ff35bae5b2b1_23a493f4-b46f-4efc-b5ee-ad10f89944ff.html,,,,,, Chloramide,10599-90-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad020079-b19c-4570-b2ed-c6a1283a3331/documents/IUC5-841f8f6f-4f14-4deb-a153-ff35bae5b2b1_23a493f4-b46f-4efc-b5ee-ad10f89944ff.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5.79 mg/kg bw/day,,mouse Chloramide,10599-90-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad020079-b19c-4570-b2ed-c6a1283a3331/documents/IUC5-841f8f6f-4f14-4deb-a153-ff35bae5b2b1_23a493f4-b46f-4efc-b5ee-ad10f89944ff.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.287 mg/m3,no adverse effect observed,rat Chlordiazepoxide,58-25-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): HSDB(Hazardous Substances Data Bank)-U.S. Department of Health & Human Services, online ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a695aeb9-1d6c-4a80-8b4b-f8866d8bdc2c/documents/0ffe5379-2562-4c14-95b5-668b00f25867_63d19652-352d-49e8-8fe1-7c95a99dad47.html,,,,,, Chlordiazepoxide,58-25-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a695aeb9-1d6c-4a80-8b4b-f8866d8bdc2c/documents/0ffe5379-2562-4c14-95b5-668b00f25867_63d19652-352d-49e8-8fe1-7c95a99dad47.html,,oral,LD50,392 mg/kg bw,adverse effect observed, Chloro(methyl)silane,993-00-0,See Discussion section below ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c72610b-98ca-4fba-8e59-3290360fd310/documents/IUC5-f627cfe0-3c8b-4ed1-905c-7544d4ecc2ff_a0247285-6918-4b18-aa3c-2da52540fd7f.html,,,,,, Chloro(methyl)silane,993-00-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c72610b-98ca-4fba-8e59-3290360fd310/documents/IUC5-f627cfe0-3c8b-4ed1-905c-7544d4ecc2ff_a0247285-6918-4b18-aa3c-2da52540fd7f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,, Chloro(methyl)silane,993-00-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c72610b-98ca-4fba-8e59-3290360fd310/documents/IUC5-f627cfe0-3c8b-4ed1-905c-7544d4ecc2ff_a0247285-6918-4b18-aa3c-2da52540fd7f.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"2,213.5 mg/m3",, Chloro(methyl)silane,993-00-0,"No acute toxicity data are available for chloro(methyl)silane. However, the substance hydrolyses rapidly in contact with moisture, generating hydrogen chloride (HCl). It is therefore expected to be corrosive to skin and, in accordance with Column 2 of REACH Annexes VII and VIII, it is not necessary to perform further testing for the acute oral, inhalation or dermal endpoints. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c72610b-98ca-4fba-8e59-3290360fd310/documents/IUC5-57303db3-d216-4fc5-8be1-452e6ccf7d27_a0247285-6918-4b18-aa3c-2da52540fd7f.html,,,,,, Chloroacetone,78-95-5, The study does not need to be conducted as the test item is classified for skin corrosion (reference 7.2.1-1). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f2f3c38-21f1-489a-bcae-97a13d786300/documents/ac30f424-ba77-492b-b969-e2d6357c3d75_68d47b6a-5d6d-4e2a-8063-9635a6915959.html,,,,,, Chloroacetyl chloride,79-04-9,"Data waiving: According to column 2 of REACH Annex VII, the acute toxicity studies do not need to be conducted since the substance is classified as corrosive to the skin.Futhermore, the substance is included in the harmonised classification and labelling list. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2421e8e-5d51-4032-bf77-867e55cbdfdc/documents/IUC5-fd1311b8-7cb0-460e-9faf-f8e7d268cec5_a5537579-00c7-460d-9859-7d10ec689ae9.html,,,,,, Chlorobenzene,108-90-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eefd2ed5-3b79-40c4-ac1b-f2902c41df6b/documents/IUC5-be9add7f-1046-4d67-961b-fec78e3a04a8_d65c4996-6e7e-49a2-93bf-26fb649640ff.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,234 mg/m3,, Chlorobenzene,108-90-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eefd2ed5-3b79-40c4-ac1b-f2902c41df6b/documents/IUC5-be9add7f-1046-4d67-961b-fec78e3a04a8_d65c4996-6e7e-49a2-93bf-26fb649640ff.html,Chronic toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,, Chlorobenzene,108-90-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eefd2ed5-3b79-40c4-ac1b-f2902c41df6b/documents/IUC5-43f2d743-245b-4828-bd98-9c2438f18d6d_d65c4996-6e7e-49a2-93bf-26fb649640ff.html,,oral,LD50,"2,000 mg/kg bw",, Chlorobenzene,108-90-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eefd2ed5-3b79-40c4-ac1b-f2902c41df6b/documents/IUC5-43f2d743-245b-4828-bd98-9c2438f18d6d_d65c4996-6e7e-49a2-93bf-26fb649640ff.html,,inhalation,LC50,66 mg/m3,, Chlorodimethyloctadecylsilane,18643-08-8,"Oral (OECD 422), rat: NOAEL = 300 mg/kg bw/day (RA CAS 70851-50-2) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5efa14d5-abdf-4ada-a8a5-7b99aa2ba83b/documents/23af1564-7a47-4a88-9dd8-6c7370ea28de_7a887d8c-6af3-4e2b-8de9-f3f2eb4d86c0.html,,,,,, Chlorodimethyloctadecylsilane,18643-08-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5efa14d5-abdf-4ada-a8a5-7b99aa2ba83b/documents/23af1564-7a47-4a88-9dd8-6c7370ea28de_7a887d8c-6af3-4e2b-8de9-f3f2eb4d86c0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Chlorodimethyloctadecylsilane,18643-08-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5efa14d5-abdf-4ada-a8a5-7b99aa2ba83b/documents/23af1564-7a47-4a88-9dd8-6c7370ea28de_7a887d8c-6af3-4e2b-8de9-f3f2eb4d86c0.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 mg/m3,adverse effect observed,rat Chlorodimethyloctadecylsilane,18643-08-8,"Acute oral toxicity (OECD 423, rat): LD50 cut-off = 2500 mg/kg bw There are no acute toxicity data available by the dermal and inhalation route. However, in accordance with Column 2 of REACH Annex VIII, acute toxicity studies (required in Section 8.5) do not need to be conducted as the substance is classified as corrosive to skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5efa14d5-abdf-4ada-a8a5-7b99aa2ba83b/documents/d29c072e-e119-45e3-b593-b68eafb86e5e_7a887d8c-6af3-4e2b-8de9-f3f2eb4d86c0.html,,,,,, Chlorodimethyloctadecylsilane,18643-08-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5efa14d5-abdf-4ada-a8a5-7b99aa2ba83b/documents/d29c072e-e119-45e3-b593-b68eafb86e5e_7a887d8c-6af3-4e2b-8de9-f3f2eb4d86c0.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, Chlorodimethyloctylsilane,18162-84-0," There are no reliable acute toxicity data. However, in accordance with Column 2 of REACH Annexes VII and VIII, acute toxicity studies (required in Section 8.5) do not need to be conducted as the substance is classified as corrosive to skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/513a0aed-3707-47dd-acaa-1cd4b2a3513b/documents/7f65d5e3-7bb5-4fa3-a54a-43ff0cb07147_030c38bc-0259-48e9-9c69-efc743116030.html,,,,,, Chlorodimethylsilane,1066-35-9,"In the key repeated 28-day oral study (Ramm & Bomhard, 1986) read-across from trimethylsilanol, adverse effects (reduced body weight gain, reduced alkaline phosphatase, reduced glucose (males), increased liver weights (females), and increased adrenal weights (males), and minor deposits in the bile ducts) were observed at the highest dose of 750 mg/kg bw/day. The NOAEL was 250 mg/kg bw/day, as effects observed at this or the lower dose of 80 mg/kg bw/day, were not dose-dependent and often values were within the normal range for historical controls.In the key repeated inhalation study (Fleeman, 2008; an OECD 422 study) read-across from trimethylsilanol, test substance-related effects were limited to changes in hematology (lower eosinophil and lymphocyte counts for males) and serum chemistry (higher alanine aminotransferase for males and toxicity phase females) at 600 ppm trimethylsilanol. These changes occurred in the absence of correlating histologic changes and were not considered adverse. Therefore, under the conditions of this screening study, an exposure level of 600 ppm (2213.5 mg/m3) was considered to be the no-observed-adverse-effect level (NOAEL) for trimethylsilanol. Since chlorodimethylsilane is hydrolysed to dimethylsilane and hydrogen chloride, additional local irritation can be expected due to the acidic nature of the HCl. There are no data for the oral and dermal routes. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25926209-6165-4ee2-9f83-f521a02f0b93/documents/a25fcb99-6fbb-4922-8257-7aa6c67e184c_350134e7-dc8b-4b64-9cb4-6503bb4ce94e.html,,,,,, Chlorodimethylsilane,1066-35-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25926209-6165-4ee2-9f83-f521a02f0b93/documents/a25fcb99-6fbb-4922-8257-7aa6c67e184c_350134e7-dc8b-4b64-9cb4-6503bb4ce94e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,, Chlorodimethylsilane,1066-35-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25926209-6165-4ee2-9f83-f521a02f0b93/documents/a25fcb99-6fbb-4922-8257-7aa6c67e184c_350134e7-dc8b-4b64-9cb4-6503bb4ce94e.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"2,213.5 mg/m3",, Chlorodimethylsilane,1066-35-9,"In the key inhalation study (DCC, 2000) the one-hour LC50 value was 4478 ppm (17329.59 mg/m3) in rats (based on nominal concentrations). The main clinical effects (excluding death) were local effects on the respiratory tract and the eyes. Division of this 1-hour LC50 by two provides a 4-hour LC50 of 8664.8 mg/m3 for classification purposes. There are no data for the oral and dermal routes of exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25926209-6165-4ee2-9f83-f521a02f0b93/documents/147d5a25-6a93-40c1-bd0b-705200a1f14b_350134e7-dc8b-4b64-9cb4-6503bb4ce94e.html,,,,,, Chlorodimethylsilane,1066-35-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25926209-6165-4ee2-9f83-f521a02f0b93/documents/147d5a25-6a93-40c1-bd0b-705200a1f14b_350134e7-dc8b-4b64-9cb4-6503bb4ce94e.html,,inhalation,LC50,"8,664.8 mg/m3",, Chlorodimethylvinylsilane,1719-58-0,"No data are available for the repeated dose oral and inhalation toxicity of chloro(dimethyl)vinylsilane, therefore good quality data for the analogue of the hydrolysis product have been read-across to address the potential for systemic toxicity. In a 28-day repeated dose oral toxicity study in rats with trimethylsilanol, conducted in accordance with OECD 407 but lacking Functional Observation Battery examinations, the NOAEL was determined to be 250 mg/kg bw/day (Ramm and Bomhard, 1986). At the highest dose level, 750 mg/kg bw/day, adverse effects included increased relative liver weight in females and small deposits of brown pigment in the bile ducts of 4/5 males. Minimal bile duct proliferation was also observed in one male in the high dose group. In a repeated dose inhalation study with trimethylsilanol conducted according to OECD 422 and in compliance with GLP (Fleeman, 2008), there were no adverse effects at any test concentration up to 600 ppm (ca. 2210 mg/m3).In a 4-week inhalation study conducted specifically to assess respiratory tract changes and local toxicity, dichloro(dimethyl) silane was administered to rats at 5 or 25 ppm resulting in concentration-related effects in the nasal cavity indicative of a local irritant effect. The local effects noted at 25 ppm (resulting in 50ppm HCl on hydrolysis) were considered to be generally comparable to the group receiving hydrogen chloride at 50 ppm in the same study.For local effects a good quality study on hydrogen chloride is available. In a 90-day repeated dose inhalation study, rats and mice (Toxigenics, 1983), were exposed to test concentrations of 0, 10, 20 and 50 ppm hydrogen chloride gas (HCl). Treatment was whole-body exposure for 6 hour per day, 5 days per week. The NOAEC for systemic effects was determined to be 20 ppm (approximately 30 mg/m3) based on decreased body weight following exposure to 50 ppm. A NOAEC could not be established as irritation/corrosion was observed at every concentration. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f829184-3c4d-41ed-96a5-e31a1647df88/documents/8d508ffb-72ba-4530-8cd0-683823e9ed1d_3e09dd16-24d9-4aaf-8615-f12778e3472c.html,,,,,, Chlorodimethylvinylsilane,1719-58-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f829184-3c4d-41ed-96a5-e31a1647df88/documents/8d508ffb-72ba-4530-8cd0-683823e9ed1d_3e09dd16-24d9-4aaf-8615-f12778e3472c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Chlorodimethylvinylsilane,1719-58-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f829184-3c4d-41ed-96a5-e31a1647df88/documents/8d508ffb-72ba-4530-8cd0-683823e9ed1d_3e09dd16-24d9-4aaf-8615-f12778e3472c.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"2,210 mg/m3",,rat Chlorodimethylvinylsilane,1719-58-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f829184-3c4d-41ed-96a5-e31a1647df88/documents/8d508ffb-72ba-4530-8cd0-683823e9ed1d_3e09dd16-24d9-4aaf-8615-f12778e3472c.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 mg/m3,adverse effect observed,rat Chlorodimethylvinylsilane,1719-58-0,"The key acute oral study (LPT, 2002), conducted according to the guideline for the Acute Toxic Class method and GLP, reported an LD50 in male and female rats in the range 200-2000 mg/kg bw. At 2000 mg/kg bw all animals died, at 200 mg/kg bw no deaths and no overt signs of systemic toxicity were observed. In accordance with OECD 423 (1996) this implicates the LD50 to be between 300 and 500 mg/kg bw. A limited, non-guideline, non-GLP inhalation study (Dow Corning, 1969) reported the death of all rats exposed to an atmosphere said to be saturated with the test material within 27 minutes. Extensive ocular and respiratory irritation were reported within 3 minutes.There are no data for the dermal route and the corrosive nature of the test material means that (adequate) acute studies via the inhalation and dermal routes (required in Section 8.5.2 and 8.5.3, Annex VIII) do not need to be conducted. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f829184-3c4d-41ed-96a5-e31a1647df88/documents/5b1a8b67-efb9-49e8-970a-5c353b1eafd9_3e09dd16-24d9-4aaf-8615-f12778e3472c.html,,,,,, Chlorodimethylvinylsilane,1719-58-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f829184-3c4d-41ed-96a5-e31a1647df88/documents/5b1a8b67-efb9-49e8-970a-5c353b1eafd9_3e09dd16-24d9-4aaf-8615-f12778e3472c.html,,oral,LD50,200 mg/kg bw,adverse effect observed, Chlorodiphenylphosphine,1079-66-9,"The information on acute toxicity is limited. The substance is highly reactive and releases hydrochloric acid upon contact with water. As such, it is corrosive.oral: The oral LD50 in rats was calculated to be 316 mg/kg bw.inhalative: The LC50 in rats was determined to be higher than 2.32 mg/L.dermal: The dermal LD50 was determined to be greater than 2150 mg/kg bw after occulsive application to the skin of rabbits. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/baad037b-3dac-416c-80a1-ae438d0766d7/documents/IUC5-9a80f775-328b-47ca-9353-8af3a76be21f_fce17d38-9160-49b2-8da7-8aba013c908e.html,,,,,, Chlorodiphenylphosphine,1079-66-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/baad037b-3dac-416c-80a1-ae438d0766d7/documents/IUC5-9a80f775-328b-47ca-9353-8af3a76be21f_fce17d38-9160-49b2-8da7-8aba013c908e.html,,oral,LD50,316 mg/kg bw,adverse effect observed, Chlorodiphenylphosphine,1079-66-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/baad037b-3dac-416c-80a1-ae438d0766d7/documents/IUC5-9a80f775-328b-47ca-9353-8af3a76be21f_fce17d38-9160-49b2-8da7-8aba013c908e.html,,dermal,LD50,"2,150 mg/kg bw",adverse effect observed, Chlorodiphenylphosphine,1079-66-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/baad037b-3dac-416c-80a1-ae438d0766d7/documents/IUC5-9a80f775-328b-47ca-9353-8af3a76be21f_fce17d38-9160-49b2-8da7-8aba013c908e.html,,inhalation,discriminating conc.,"2,320 mg/m3",no adverse effect observed, Chlorotrifluoroethylene,79-38-9," As the test substance is a gas at room temperature, studies through oral and dermal routes are not feasible. CTFE was tested by inhalation for subacute and subchronic toxicity in several studies and on several species (rat, rabbit, guinea pig and dog). Basing on the findings CTFE is observed to be nephrotoxicant in the rat a relatively low concentration. From the 13 week subchronic study on rat (Gad, et al., 1988), the NOAEC (90day) was established to be 29 ppm in air, which corresponds to 138.14 mg/m3 at 25°C and 760 Torr. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d73b98c1-dbe5-4099-84f0-c4529a346e09/documents/IUC5-c47f57af-75b4-4878-914e-a6692ae69513_74ae38be-47e3-4991-9ce5-48aa191b97e2.html,,,,,, Chlorotrifluoroethylene,79-38-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d73b98c1-dbe5-4099-84f0-c4529a346e09/documents/IUC5-c47f57af-75b4-4878-914e-a6692ae69513_74ae38be-47e3-4991-9ce5-48aa191b97e2.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,138.14 mg/m3,,rat Chlorotrifluoroethylene,79-38-9," As the test substance is a gas at room temperature, studies through oral and dermal routes are not feasible.   Several studies (K2 or K4) through the inhalation route are available, performed on several species (rat, mouse, guinea pig, rabbit, dog).The key study (Waltheret al.,1970) for this endpoint was selected between the studies having K2 reliability and covering the range of exposure concentrations suitable for classification according to EU GHS criteria.   CTFE is classified as Acute Toxicity by Inhalation Category 3 based on the LC50 (4h, mouse) > 1000 ppm; < 3000 ppm. Kidney appears to be the target organ of CTFE, and nephrotoxicity has been observed to be the main cause of the observed lethality. The effects observed on kidney at not lethal concentration are consistent with the effects observed at higher concentration which leaded mortality. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d73b98c1-dbe5-4099-84f0-c4529a346e09/documents/IUC5-4ecbc0c4-bd91-42d2-a4f8-479dbd6af1be_74ae38be-47e3-4991-9ce5-48aa191b97e2.html,,,,,, Chlorotrifluoroethylene,79-38-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d73b98c1-dbe5-4099-84f0-c4529a346e09/documents/IUC5-4ecbc0c4-bd91-42d2-a4f8-479dbd6af1be_74ae38be-47e3-4991-9ce5-48aa191b97e2.html,,inhalation,LC50,"11,580 mg/m3",adverse effect observed, Chlorotrimethylsilane,75-77-4,"There are no studies of sufficient duration that assess the repeated dose toxicity of chlorotrimethylsilane. Therefore results from a key inhalation OECD 422 study on the hydrolysis product, trimethylsilanol have been read-across to support this endpoint for chlorotrimethylsilane. In this study the NOAEC for trimethylsilanol was at least 600 ppm (2666 mg/m3). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/839987f2-64ff-4f0c-94b5-83b327147bca/documents/44cccceb-8949-4259-9c65-f1cb2332d688_ca4df645-fc3e-492a-a58d-52686f92c89d.html,,,,,, Chlorotrimethylsilane,75-77-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/839987f2-64ff-4f0c-94b5-83b327147bca/documents/44cccceb-8949-4259-9c65-f1cb2332d688_ca4df645-fc3e-492a-a58d-52686f92c89d.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"2,666 mg/m3",, Chlorotrimethylsilane,75-77-4,"In a well-reported acute oral toxicity study conducted using a protocol similar to the now deleted OECD test guideline 401 (of unknown GLP status), the LD50 was <0.25ml/kg for undiluted organochlorosilane (214 mg/kg) (BRRC 1982). In an acute dermal toxicity study conducted using a protocol similar to OECD test guideline 402 (of unknown GLP status), the LD50 for Organochlorosilane A-161 was 2.38 ml/kg for males and 1.78 ml/kg for females (2037 and 1527 mg/kg, respectively, based on a specific gravity of 0.856) (BRRC 1982). In an acute inhalation study conducted according to OECD test guideline 403, the acute one-hour LC50 , based on nominal concentrations, was determined to be 4257 ppm (nominal; adjustment for exposure period gives LC50 of 2128.5 ppm) (Jean 1999). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/839987f2-64ff-4f0c-94b5-83b327147bca/documents/9aa097c9-26ef-47c5-84be-36b9610739e9_ca4df645-fc3e-492a-a58d-52686f92c89d.html,,,,,, Chlorotrimethylsilane,75-77-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/839987f2-64ff-4f0c-94b5-83b327147bca/documents/9aa097c9-26ef-47c5-84be-36b9610739e9_ca4df645-fc3e-492a-a58d-52686f92c89d.html,,oral,LD50,214 mg/kg bw,, Chlorotrimethylsilane,75-77-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/839987f2-64ff-4f0c-94b5-83b327147bca/documents/9aa097c9-26ef-47c5-84be-36b9610739e9_ca4df645-fc3e-492a-a58d-52686f92c89d.html,,dermal,LD50,"1,527 mg/kg bw",, Chlorotrimethylsilane,75-77-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/839987f2-64ff-4f0c-94b5-83b327147bca/documents/9aa097c9-26ef-47c5-84be-36b9610739e9_ca4df645-fc3e-492a-a58d-52686f92c89d.html,,inhalation,LC50,"9,458 mg/m3",, Chlorotrioctylstannane,2587-76-0,"ORALNOAEL 17 mg/kg bw/day, rat (female) and NOAEL 20 mg/kg bw/day, rat (male); OECD 422, Waalkens-Berendsen (2004) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7695703b-4511-464d-8362-94781be8fcda/documents/81979f4a-6d15-4bea-a5ac-78a85010abd0_70ecd194-542e-47e6-903f-981c441714ef.html,,,,,, Chlorotrioctylstannane,2587-76-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7695703b-4511-464d-8362-94781be8fcda/documents/81979f4a-6d15-4bea-a5ac-78a85010abd0_70ecd194-542e-47e6-903f-981c441714ef.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat Chlorotrioctylstannane,2587-76-0," OralLD50> 4000 mg/kg rat (male/female), Günzel & Richter (1968)LD50 28 641.6 mg/kg rat (male), Klimmer (1970) InhalationLC50 250 mg/m³, rat (male/female), Sachsse & Ullmann (1974) IntraperitonealLD50 325 mg/kg, rat (male/female), Günzel & Richter (1969) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7695703b-4511-464d-8362-94781be8fcda/documents/9e1e4671-7891-4249-85b2-0d0e2e78303f_70ecd194-542e-47e6-903f-981c441714ef.html,,,,,, Chlorotrioctylstannane,2587-76-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7695703b-4511-464d-8362-94781be8fcda/documents/9e1e4671-7891-4249-85b2-0d0e2e78303f_70ecd194-542e-47e6-903f-981c441714ef.html,,oral,LD50,"4,000 mg/kg bw",no adverse effect observed, Chlorotrioctylstannane,2587-76-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7695703b-4511-464d-8362-94781be8fcda/documents/9e1e4671-7891-4249-85b2-0d0e2e78303f_70ecd194-542e-47e6-903f-981c441714ef.html,,inhalation,LC50,250 mg/m3,adverse effect observed, Choline hydroxide,123-41-1," Repeated dose toxicity: - Chronic (72 weeks + 31 weeks post-observation) study oral (feed), rat (Fischer 344) male (similar to OECD guideline 452): NOAEL > 1200 mg/kg bw/day choline chloride (highest / only dose tested), recalculated to 1040 mg/kg bw/day choline hydroxide - Subchronic (3 – 4 months) study oral (feed and drinking water), rat m/f (similar to OECD Guideline 408): NOAEL = 1300 – 2900 mg/kg bw/day choline chloride, recalculated to 1130 - 2520 mg/kg bw/day choline hydroxide, LOAEL = 3400 – 5000 mg/kg bw/day choline chloride, recalculated to 2950 - 4340 mg/kg bw/day choline hydroxide - Subacute (28 day) study oral (gavage), intraperitoneal and intranasal, mouse (Balb/c) m/f (GLP, OECD Guideline 407 / no guideline available): NOEL > 200 mg/kg bw/day choline chloride (highest / only dose tested), recalculated to 174 mg/kg bw/day choline hydroxide ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d6152674-d2e6-409c-bc05-1d924a7c7b4c/documents/IUC5-075a6f7f-ec5f-4302-9b94-be6b481cc6b5_49e60db1-cbba-46df-a3b2-e69029e48f34.html,,,,,, Choline hydroxide,123-41-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d6152674-d2e6-409c-bc05-1d924a7c7b4c/documents/IUC5-075a6f7f-ec5f-4302-9b94-be6b481cc6b5_49e60db1-cbba-46df-a3b2-e69029e48f34.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,040 mg/kg bw/day",,rat Choline hydroxide,123-41-1,"1) BASF, 1963 - Read across from choline chloride, key, acute oral toxicity, rats, recalculated LD50 ca. 3040 mg/kg bw 2) BASF, 1969 - Read across from choline chloride, supporting, acute oral toxicity, rats, recalculated LD50 ca. 4770 mg/kg bw 3) Salazar-Rodriguez/Sosa, 2004 - Read across from choline chloride, supporting, acute oral toxicity, rats, recalculated LD0 ≥ 2.42 g/kg bw, recalculated intermittent total dose LD0 ≥ 7.26 g/kg bw (3 consecutive days) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Two equivalent studies assessed with Klimisch 2 and one supporting study (Klimisch 4 because only abstracts could be retrieved) on the read-across substance choline chloride are available to cover the endpoint ""Acute Toxicity: oral"". Furthermore, the study on acute toxicity generally does not need to be conducted asthe substance is classified as corrosive to the skin. Hence, the available information meets fully the tonnage-driven data requirements of REACH. Additionally, all available studies revealed equivalent result, i.e. are all above the boundary value of 2000 mg/kg bw for classification, and so the outcomes of the studies are consistent. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6152674-d2e6-409c-bc05-1d924a7c7b4c/documents/IUC5-1914ca79-2937-4fc1-99fb-50961b4893c7_49e60db1-cbba-46df-a3b2-e69029e48f34.html,,,,,, Choline hydroxide,123-41-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6152674-d2e6-409c-bc05-1d924a7c7b4c/documents/IUC5-1914ca79-2937-4fc1-99fb-50961b4893c7_49e60db1-cbba-46df-a3b2-e69029e48f34.html,,oral,LD50,"3,040 mg/kg bw",no adverse effect observed, "Chromate(1-), [2,4-dihydro-4-[(2-hydroxy-5-methyl-3-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[4-[[5-(2,2-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonamidato(2-)]-, hydrogen",72928-87-1," Acute oral toxicity:  Acute oral toxicity dose (LD50) for Chromate(1 -),[2,4-dihydro-4-[(2-hydroxy-5-methyl-3-nitrophenyl)azo]-5-methyl-2-phenyl-3H pyrazol-3-onato(2 -)][3-[4-[[5-(2,2-dimethylpropyl)-2-hydroxy-3 -nitrophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonamidato(2-)]-, hydrogen (CAS No.72928-87-1) was predicted based on OECD QSAR toolbox 5413 mg/kg bw and different studies available on structurally similar read across substances 4,4'-(1E,1'E)-(3,3'-dichlorobiphenyl-4,4'-diyl)bis(diazene-2,1-diyl)bis(3-methyl-1-phenyl-1H-pyrazol-5(4H)-one) (CAS no: 3520-72-7) >5000 mg/kg bw and Disodium hydrogen bis[5-chloro-3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxybenzenesulphonato(3-)]chromate(3-) (6408-26-0) >15000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Chromate(1 -),[2,4-dihydro-4-[(2-hydroxy-5-methyl-3-nitrophenyl)azo]-5-methyl-2-phenyl-3H pyrazol-3-onato(2 -)][3-[4-[[5-(2,2-dimethylpropyl)-2-hydroxy-3 -nitrophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonamidato(2-)]-, hydrogen cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure of humans via inhalation route is not likely taking into account due to the low vapour pressure of the substance Chromate(1 -),[2,4-dihydro-4-[(2-hydroxy-5-methyl-3-nitrophenyl)azo]-5-methyl-2-phenyl-3H pyrazol-3-onato(2 -)][3-[4-[[5-(2,2-dimethylpropyl)-2-hydroxy-3 -nitrophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonamidato(2-)]-, hydrogen (CAS No.72928-87-1), which is reported as 1.58E-31 Pa; High melting point, which is reported as 350˚C; Also considering the particle size distribution of the substance, the majority of the particles were found to be in the size of range 150 micrometer to 53 micrometer which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical Chromate(1 -),[2,4-dihydro-4-[(2-hydroxy-5-methyl-3-nitrophenyl)azo]-5-methyl-2-phenyl-3H pyrazol-3-onato(2 -)][3-[4-[[5-(2,2-dimethylpropyl)-2-hydroxy-3 -nitrophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonamidato(2-)]-, hydrogen is highly unlikely. Therefore this study is considered for waiver. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/baed62fd-0956-40e6-b966-d4c828c256e0/documents/a586d300-72e4-45d6-8051-c2382d9a241f_924b6cb9-8b22-4e3a-add0-081e3bbe2afe.html,,,,,, "Chromate(1-), [2,4-dihydro-4-[(2-hydroxy-5-methyl-3-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[4-[[5-(2,2-dimethylpropyl)-2-hydroxy-3-nitrophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonamidato(2-)]-, hydrogen",72928-87-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/baed62fd-0956-40e6-b966-d4c828c256e0/documents/a586d300-72e4-45d6-8051-c2382d9a241f_924b6cb9-8b22-4e3a-add0-081e3bbe2afe.html,,oral,LD50,"5,413 mg/kg bw",no adverse effect observed, "Chromate(1-), bis[4-[[4-(ethylsulfonyl)-2-hydroxyphenyl]azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, compd. with 1,6-hexanediamine (2:1)",69997-91-7, In two acute oral toxicity studies in rats LD50 values of  above 7000 mg/kg bw and above 7750 mg/kg bw were determined. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bab4001-b714-4f2b-987e-5e03ccc72a03/documents/1384ad8a-ba83-4df1-ae46-94cdc194076a_47c39b18-9c13-4347-a842-4079a4db953b.html,,,,,, "Chromate(1-), bis[4-[[4-(ethylsulfonyl)-2-hydroxyphenyl]azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, compd. with 1,6-hexanediamine (2:1)",69997-91-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bab4001-b714-4f2b-987e-5e03ccc72a03/documents/1384ad8a-ba83-4df1-ae46-94cdc194076a_47c39b18-9c13-4347-a842-4079a4db953b.html,,oral,discriminating dose,"7,000 mg/kg bw",no adverse effect observed, "Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium",70209-87-9,"Based on the results obtained in the 28-day repeated toxicity study, the NOAEL of the test substance is 300 mg/kg body weight for male and females rats when administered orally by gavage. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29981ebb-4533-46ab-8095-00b283832ddc/documents/IUC5-2385a3b2-890d-47d3-9c9b-1cdec2db86f5_bb1525f3-348b-4926-970b-dd62fe22450e.html,,,,,, "Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium",70209-87-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29981ebb-4533-46ab-8095-00b283832ddc/documents/IUC5-2385a3b2-890d-47d3-9c9b-1cdec2db86f5_bb1525f3-348b-4926-970b-dd62fe22450e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium",70209-87-9,The oral LD50 for the substance was considered to be 1717 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29981ebb-4533-46ab-8095-00b283832ddc/documents/IUC5-4e088e78-4d5f-492a-8e06-f64676ed7401_bb1525f3-348b-4926-970b-dd62fe22450e.html,,,,,, "Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium",70209-87-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29981ebb-4533-46ab-8095-00b283832ddc/documents/IUC5-4e088e78-4d5f-492a-8e06-f64676ed7401_bb1525f3-348b-4926-970b-dd62fe22450e.html,,oral,LD50,"1,717 mg/kg bw",adverse effect observed, "Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]-, disodium",83833-37-8, LD50 = 4425 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dedd9ae7-68bb-4353-8c3b-cf15fb96c46b/documents/402dba18-f11a-4588-aa50-2fa5c16b33b1_0a60d1f5-3c95-4c4d-9aae-3ce5ce216324.html,,,,,, "Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxy-1-naphthalenesulfonato(3-)]-, disodium",83833-37-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dedd9ae7-68bb-4353-8c3b-cf15fb96c46b/documents/402dba18-f11a-4588-aa50-2fa5c16b33b1_0a60d1f5-3c95-4c4d-9aae-3ce5ce216324.html,,oral,LD50,"4,425 mg/kg bw",no adverse effect observed, "Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-3H-pyrazol-3-onato(2-)][3-[[4,5-dihydro-3-methyl-1-(4-methylphenyl)-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium",75199-08-5," Based on a calculated LD50 of 5004 mg/kg bw, experimentally derived in Wistar rats (oral, gavage), the test item is not considered to be acutely toxic via oral exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c16a579-731a-4dbd-854d-3585a337573d/documents/dcf9e304-c0f6-4424-ad52-63dadd2d1b7b_335b8257-9e1e-4dd3-b9b3-c8d7d04eb114.html,,,,,, "Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-3H-pyrazol-3-onato(2-)][3-[[4,5-dihydro-3-methyl-1-(4-methylphenyl)-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium",75199-08-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c16a579-731a-4dbd-854d-3585a337573d/documents/dcf9e304-c0f6-4424-ad52-63dadd2d1b7b_335b8257-9e1e-4dd3-b9b3-c8d7d04eb114.html,,oral,LD50,"5,004 mg/kg bw",no adverse effect observed, "Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium",56819-40-0,LD50 >5000 mg/kg bw (based on test material)LD50 >2850 mg/kg bw (based on active ingredient) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d209edef-5b6b-46b9-ad17-87a3f83062b8/documents/IUC5-c39aadb6-9184-45e8-8cac-5ce94cb95e8c_71e96292-380e-475a-b89c-637f1c10b6ee.html,,,,,, "Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium",56819-40-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d209edef-5b6b-46b9-ad17-87a3f83062b8/documents/IUC5-c39aadb6-9184-45e8-8cac-5ce94cb95e8c_71e96292-380e-475a-b89c-637f1c10b6ee.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Chromate(2-), [3-[4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)][2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, sodium",90294-40-9, LD50 >5000 mg/kg bw (based on test material) LD50 >2850 mg/kg bw (based on active ingredient) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d0055aa-a41f-49d5-9bcb-0b5f6a21a850/documents/f9b68926-6ab4-4ea4-912d-e817d9cb1a08_d5389748-1070-4989-8c50-a0cf45bf5895.html,,,,,, "Chromate(2-), [4-[(5-chloro-2-hydroxy-3-nitrophenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium",72017-66-4,"Acute toxicity: oral Acid Red 407 was assessed for acute toxicity potential in several studies over the years. The acute oral toxicity of FAT 20202/B (active ingredient ca. 71.3 %) was evaluated using methodology similar to OECD Guideline 401. In this study, gropus of rats each containing 5 males and 5 females, were administered FAT 20202/B at 2000, 2500, 3000 and 5000 mg/kg bw via gavage. After administration of the compound, the animals were observed for 14 days. No mortality was seen at 2000 mg/kg bw, however, % mortality observed was 50 (5 females), 70 (2 males and 5 females) and 100 (5 males and 5 females) at 2500, 3000 and 5000 mg/kg bw respectively. Sedation, dyspnoea, exophthalmos, ruffled fur, diarrhoea and curved body position were the clinical signs observed. The surviving animals recovered by day 8. At autopsy no changes caused by the administration of FAT 20202/B were seen.In conclusion, the acute oral LD50 of FAT 20202/B in rats of both sexes observed over a period of 14 days is 2696 mg/kg bw. The acute oral toxicity of FAT 20202/D (active ingredient ca. 27.5 %) was assessed using 3 male and 3 female young albino rats. A single dose of 5000 mg/kg bw was administered via gavage. After administration of the compound, the animals were observed for 14 days. Mortality and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. Dyspnea, ruffled fur, and curved body position were seen, being common symptoms in acute toxicity testing were seen but no deaths occurred. At autopsy no changes caused by the administration of FAT 20202/D were seen.In conclusion, the acute oral LD50 of FAT 20202/D in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg bw. The oral LD50 for FAT 20202/A (active ingredient ca. 25 %) was determined to be >15000 mg/kg bw from the findings of the study conducted using similar methodology as given in OECD Guideline 401.   Acute toxicity: inhalation Currently no study for assessment of acute inhalation toxicity of Acid Red 407 is available. However, it was estimated to have low vapour pressure (<0.5 KPa) owing to high melting point (> 350 °C), so the potential for the generation of inhalable forms is low. Synthesis and spray drying of this chemical is performed in a closed process; the final product consists of non-dusty granules. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets. Referring to the expected low volatility of the substance, the fact that the substance is imported into the EU in a formulated form as a dust-free powder or as a granulate, the exposure via inhalation is considered to be unlikely. Acid Red 407 was found to have water solubility of 10.9 g/L, hence, if any dust of this hydrophilic substance enters the respiratory tract, it may be retained within the mucus and cleared through mucociliary system. The chemical showed low toxicity potential in the available acute oral toxicity studies with LD50 being 2696 mg/kg bw, hence, it does not need to be classified as STOT SE. Taking the above arguments into consideration, low toxicity potential is expected on acute exposure of Acid Red 407 via inhalation route. Hence, safety for human health can be estimated via route to route extrapolation and testing by the inhalation route was considered scientifically not necessary.   Acute toxicity: dermal Currently no study to assess acute dermal toxicity of Acid Red 407 is available. However, the molecular weight of the chemical is 920.5 g/mol, indicating it being too large for dermal absorption. It has water solubility of 10.9 g/L, indicating it being too hydrophilic to cross the lipid rich environment of the stratum corneum. Hence, the dermal uptake for the chemical is expected to be low. Production and spray drying is performed in closed processes without isolation of reaction products. Isolated products consist either of liquid formulations or of dust free granules (non-dusty solid). In addition, the use of this substance will not result in aerosols, particles or droplets, so exposure to humans via the dermal route will be unlikely to occur. Risk management measures established for workers and professionals are considered sufficient to enable safe handling and use of the final products containing the formulated dye. The chemical showed low toxicity potential in the available acute oral toxicity studies (LD50 = 2696 mg/kg bw), and it does not need to be classified STOT SE. Similarly, absence of systemic toxicity in skin irritation as well as sensitization studies further supports the conclusion that low toxicity is expected for the chemical via the dermal route. Hence, testing by the dermal route with Acid Red 407 was considered scientifically not necessary. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Good quality studies ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c6867f0-58f6-45d2-a10c-822424b7b661/documents/70a798c2-5065-4e5c-83a9-f4d29b35c1ea_ab965dc8-5d38-4e47-a3b0-ceb8ba91ba15.html,,,,,, "Chromate(2-), [4-[(5-chloro-2-hydroxy-3-nitrophenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium",72017-66-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c6867f0-58f6-45d2-a10c-822424b7b661/documents/70a798c2-5065-4e5c-83a9-f4d29b35c1ea_ab965dc8-5d38-4e47-a3b0-ceb8ba91ba15.html,,oral,LD50,"2,696 mg/kg bw",no adverse effect observed, "Chromate(2-), [4-[4-[(5-chloro-2-hydroxyphenyl)azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)][4-[(5-chloro-2-hydroxyphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, sodium",90294-36-3," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target substance Chromate(2-), [4-[4-[(5-chloro-2-hydroxyphenyl)azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)][4-[(5-chloro-2-hydroxyphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, sodium (90294-36-3) was estimated to be 5924.61 mg/kg bw,and for differentstudies available on the structurally similar read across substance 2-[[6-[(4,6-dichloro-1,3,5-triazin-2-yl)methylamino]-1-hydroxy-3-sulpho-2-naphthyl]azo]naphthalene-1,5-disulphonic acid (73816-75-8) was considered to be 8500 mg/kg bw and for Tartrazine (1934-21-0) was considered to be >6250 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Chromate(2-), [4-[4-[(5-chloro-2-hydroxyphenyl)azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)][4-[(5-chloro-2-hydroxyphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, sodium (90294-36-3) cannot be classified for acute oral toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/478db20a-fcf4-4923-b8c8-20b9470391df/documents/5fd72aea-8e5b-4177-972a-06ea7489b51f_fd9ac772-9f7c-42c5-8eeb-12897d1c350b.html,,,,,, "Chromate(2-), [4-[4-[(5-chloro-2-hydroxyphenyl)azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)][4-[(5-chloro-2-hydroxyphenyl)azo]-2,4-dihydro-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]-, sodium",90294-36-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/478db20a-fcf4-4923-b8c8-20b9470391df/documents/5fd72aea-8e5b-4177-972a-06ea7489b51f_fd9ac772-9f7c-42c5-8eeb-12897d1c350b.html,,oral,LD50,"5,924.61 mg/kg bw",no adverse effect observed, "Chromate(2-), [5-(diethylamino)-2-[(2-hydroxy-4-nitrophenyl)azo]phenolato(2-)][5-hydroxy-6-[(2-hydroxy-4-nitrophenyl)azo]-1-naphthalenesulfonato(3-)]-, sodium",90294-39-6, LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1ba4c24-5c87-4e24-8110-9329c0ff4474/documents/IUC5-0dde0441-c74d-445e-ba44-a651a4264daf_90319067-88ae-454d-85ab-c79294e9ec70.html,,,,,, "Chromate(3-), [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)][3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonato(3-)]-, sodium",84989-26-4," Oral NOAEL: 180 mg/kg bw/day (subacute, rats) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd6546c3-51e9-4e10-86e8-01581eb7f420/documents/IUC5-5103c76d-0448-44b4-9c91-b0e9239741b5_76984e7c-a242-4cab-a1ea-6d08adbf1372.html,,,,,, "Chromate(3-), [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)][3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonato(3-)]-, sodium",84989-26-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd6546c3-51e9-4e10-86e8-01581eb7f420/documents/IUC5-5103c76d-0448-44b4-9c91-b0e9239741b5_76984e7c-a242-4cab-a1ea-6d08adbf1372.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,97.2 mg/kg bw/day,,rat "Chromate(3-), [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)][3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonato(3-)]-, sodium",84989-26-4, Oral LD50: 5792 mg/kg bw (CL 95 %: 3813 - 14980 mg/kg) Dermal LD50 > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd6546c3-51e9-4e10-86e8-01581eb7f420/documents/IUC5-706d484e-6786-436e-9b96-c636097df13e_76984e7c-a242-4cab-a1ea-6d08adbf1372.html,,,,,, "Chromate(3-), [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)][3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonato(3-)]-, sodium",84989-26-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd6546c3-51e9-4e10-86e8-01581eb7f420/documents/IUC5-706d484e-6786-436e-9b96-c636097df13e_76984e7c-a242-4cab-a1ea-6d08adbf1372.html,,oral,LD50,"5,792 mg/kg bw",no adverse effect observed, "Chromate(3-), [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)][3-hydroxy-4-[(2-hydroxy-1-naphthalenyl)azo]-7-nitro-1-naphthalenesulfonato(3-)]-, sodium",84989-26-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd6546c3-51e9-4e10-86e8-01581eb7f420/documents/IUC5-706d484e-6786-436e-9b96-c636097df13e_76984e7c-a242-4cab-a1ea-6d08adbf1372.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Chrome antimony titanium buff rutile,68186-90-3," ORAL The NOAEL of >= 500 mg/kg bw/day (highest dose) was chosen from the oral 90-day key study (Bomhard et al., 1982). INHALATION The NOAEC of >= 60 mg/m3 (highest concentration) with a clearance half-life of 50 days in the lungs was taken from the 5-day inhalation key study (BASF AG, 33I0110/91008, 1994). DERMAL Assessment: dermal pathway not relevant due to lack of bioavailability. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3bfaf7a4-c53a-4003-bf35-eba3a43c541f/documents/8ea6d606-e57b-45ba-803f-76903003b8c2_3b52abe3-2a0c-4ef9-9f61-72546dad4fce.html,,,,,, Chrome antimony titanium buff rutile,68186-90-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3bfaf7a4-c53a-4003-bf35-eba3a43c541f/documents/8ea6d606-e57b-45ba-803f-76903003b8c2_3b52abe3-2a0c-4ef9-9f61-72546dad4fce.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,60 mg/m3,,rat Chrome antimony titanium buff rutile,68186-90-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3bfaf7a4-c53a-4003-bf35-eba3a43c541f/documents/8ea6d606-e57b-45ba-803f-76903003b8c2_3b52abe3-2a0c-4ef9-9f61-72546dad4fce.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Chrome antimony titanium buff rutile,68186-90-3," Acute toxicity via oral route: oral  LD50 rat > 10000 mg/kg bw (standardized test protocol; BASF 1978) Acute toxicity via inhalation route: Not relevant Acute toxicity via dermal route: No mortality or systemic toxicity was observed in a 7-h inhalation hazard test (IHT, BASF, 1978) and in a 5-d bioavailability study (BASF, 33I0110/91008, 1994; see section 7.5.2). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bfaf7a4-c53a-4003-bf35-eba3a43c541f/documents/e5069ed5-22e1-412a-90cc-464276b18f62_3b52abe3-2a0c-4ef9-9f61-72546dad4fce.html,,,,,, Chrome antimony titanium buff rutile,68186-90-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bfaf7a4-c53a-4003-bf35-eba3a43c541f/documents/e5069ed5-22e1-412a-90cc-464276b18f62_3b52abe3-2a0c-4ef9-9f61-72546dad4fce.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, Chrome tin orchid cassiterite,68187-53-1,"Acute oral toxicity: LD50 > 5000 mg/kg bw (nominal) (OECD 423; GLP compliant) Acute inhalation toxicity: LC50 > 5.06 mg/L air (analytical) (OECD 436; GLP compliant) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study fulfils the rquirements for acute oral toxicity under REACH (Regulation (EC) 1907/2006). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea9da0b6-18e3-4be7-93a7-d5ac3f97359a/documents/IUC5-4aab2322-e8a7-4cbc-9466-30548cf772c9_97d9230d-878a-4543-9523-c18d29a7f551.html,,,,,, Chrome tungsten titanium buff rutile,68186-92-5,"The assessment of repeated dose toxicity is based on tests conducted with two chemically closely related rutile pigments by Read-Across.Oral Nickel rutile (C.I. Pigment Yellow 53 (CAS no.8007-18-9))90d rat: NOAEL >= 450 mg/kg bw/d (OECD 408, Bomhard et al. 1982) chrome rutile (C.I. Pigment Brown 24 (CAS no. 68186-90-3))90d rat: NOAEL >= 500 mg/kg bw/d (OECD 408, Bomhard et al. 1982)No indications of bioavailability for both substances (Bomhard et al. 1982)DermalAssessment: dermal pathway not relevant due to lack of bioavailability.InhalationNickel rutile (C.I. Pigment Yellow 53 (CAS no.8007-18-9))rat 5 d: NOAEL >= 0.06 mg/L; clearance in the lung, no bioavailability (BASF 1994) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff01252a-062e-4dc7-bd47-88c14a2e8ce0/documents/IUC5-92ce9272-b176-4010-bb5e-a208e7484bae_0803116d-a33d-436c-8e3d-a8677dcfab78.html,,,,,, Chrome tungsten titanium buff rutile,68186-92-5,oral LD50 rat > 5000 mg/kg bw dermal not relevant inhalation LC50 > 5.08 mg/L for both sexes (MMAD: 1.257µm (GSD: 3.368)) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff01252a-062e-4dc7-bd47-88c14a2e8ce0/documents/IUC5-0846814b-981a-46b3-b82a-b6c880e1184a_0803116d-a33d-436c-8e3d-a8677dcfab78.html,,,,,, Chrome tungsten titanium buff rutile,68186-92-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff01252a-062e-4dc7-bd47-88c14a2e8ce0/documents/IUC5-0846814b-981a-46b3-b82a-b6c880e1184a_0803116d-a33d-436c-8e3d-a8677dcfab78.html,,inhalation,LC50,5.08 ,no adverse effect observed, Chromium propionate,85561-43-9," Regardless of the high Cr3+ doses, chromium(III) oxide did not cause any significant treatment-related changes in the general condition of animals, body weights, clinical biochemistry, haematology, or pathological examination. Propionic acid and associated salts are found in many foods (approved as preservative) and are formed in anima and plant cells as a metabolite from glycolysis. There is no toxicity theshold for repeated exposure in humans. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd9fa67d-5a6d-46ca-b006-f4cee8cb1c8e/documents/dd73c7ee-5a27-4efb-92f9-3685a0755447_5822c455-98f6-44f5-ab45-aaece3d33ef5.html,,,,,, Chromium propionate,85561-43-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd9fa67d-5a6d-46ca-b006-f4cee8cb1c8e/documents/dd73c7ee-5a27-4efb-92f9-3685a0755447_5822c455-98f6-44f5-ab45-aaece3d33ef5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat Chromium propionate,85561-43-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd9fa67d-5a6d-46ca-b006-f4cee8cb1c8e/documents/dd73c7ee-5a27-4efb-92f9-3685a0755447_5822c455-98f6-44f5-ab45-aaece3d33ef5.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"44,000 mg/m3",,rat Chromium propionate,85561-43-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd9fa67d-5a6d-46ca-b006-f4cee8cb1c8e/documents/dd73c7ee-5a27-4efb-92f9-3685a0755447_5822c455-98f6-44f5-ab45-aaece3d33ef5.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"44,000 mg/m3",no adverse effect observed,rat Chromium propionate,85561-43-9," From extensive work on chromium III salts, there is no evidence of acute toxicity. Some corrosive salts will cause harm at high concentrations, but this is not considered to be a toxic effect.   Propionic acid is not classified; although some reports on low molecular weight organic acids suggest Harmful (considered due to local irritation / corrosion)   In view of the wealth of data on chromium salts and propionic acid, no further animal testing is justified. It is accepted that there is no dermal absorption of metal salts such as chromium III from dermal contact.   The low oral toxicity also suggests low biological impact from contact with chromium III.  It is not considered to be justified to perform further animal tests. Skin penetration experiments on chromium chloride and chromium sulfate (1.2% chromium labelled with 51Cr) with skin chambers glued to the skin of normal volunteers. These chambers were removed at 6, 12, or 24 hours and analysis for radioactive chromium was performed at the site of the chamber as well as in the underlying epidermis and dermis. As no label was found in the lower levels of skin, it was concluded that chromium(III) salts did not permeate through the intact epidermis. Some blood samples and 24-h urine were also examined, and no radioactive chromium was detected.[Mali JWH, Van Kooten WJ, Van Neer CJ (1963) Some aspects of the behaviour of chromium compounds in the skin. Journal of Investigative Dermatology, 41:111–122]. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd9fa67d-5a6d-46ca-b006-f4cee8cb1c8e/documents/5f32be3d-40cb-4bb6-81f9-19c6469b3517_5822c455-98f6-44f5-ab45-aaece3d33ef5.html,,,,,, Chromium acetate,17593-70-3," Regardless of the high Cr3+ doses, chromium(III) oxide did not cause any significant treatment-related changes in the general condition of animals, body weights, clinical biochemistry, haematology, or pathological examination. Citric acid and associated salts are found in many foods and are formed in cells as a metabolite from glycolysis. There is no toxicity theshold for repeated exposure in humans, although acute toxic effects have been reported in animals. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1d1526a-4d0c-4af9-9c2a-94b53031148e/documents/4f4a2fa7-eb80-45d8-bc28-0b4593d9028c_e18125b2-773f-403e-89f0-b1e528b26000.html,,,,,, Chromium acetate,17593-70-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1d1526a-4d0c-4af9-9c2a-94b53031148e/documents/4f4a2fa7-eb80-45d8-bc28-0b4593d9028c_e18125b2-773f-403e-89f0-b1e528b26000.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat Chromium acetate,17593-70-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1d1526a-4d0c-4af9-9c2a-94b53031148e/documents/4f4a2fa7-eb80-45d8-bc28-0b4593d9028c_e18125b2-773f-403e-89f0-b1e528b26000.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"44,000 mg/m3",,rat Chromium acetate,17593-70-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1d1526a-4d0c-4af9-9c2a-94b53031148e/documents/4f4a2fa7-eb80-45d8-bc28-0b4593d9028c_e18125b2-773f-403e-89f0-b1e528b26000.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"44,000 mg/m3",no adverse effect observed,rat Chromium acetate,17593-70-3," From extensive work on chromium III salts, there is no evidence of acute toxicity. Some corrosive salts will cause harm at high concentrations, but this is not considered to be a toxic effect.   Acetic acid is not classified; although some reports on pure acetic acid suggest Harmful (considered due to local irritation / corrosion of the acid)   In view of the wealth of data on chromium salts and acetic acid, no further animal testing is justified. It is accepted that there is no dermal absorption of metal salts such as chromium III from dermal contact.   The low oral toxicity also suggests low biological impact from contact with chromium III.  It is not considered to be justified to perform further animal tests. Skin penetration experiments on chromium chloride and chromium sulfate (1.2% chromium labelled with 51Cr) with skin chambers glued to the skin of normal volunteers. These chambers were removed at 6, 12, or 24 hours and analysis for radioactive chromium was performed at the site of the chamber as well as in the underlying epidermis and dermis. As no label was found in the lower levels of skin, it was concluded that chromium(III) salts did not permeate through the intact epidermis. Some blood samples and 24-h urine were also examined, and no radioactive chromium was detected.[Mali JWH, Van Kooten WJ, Van Neer CJ (1963) Some aspects of the behaviour of chromium compounds in the skin. Journal of Investigative Dermatology, 41:111–122]. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1d1526a-4d0c-4af9-9c2a-94b53031148e/documents/4ae3a2c7-5d1e-4e94-b4b0-56cafb1ead0d_e18125b2-773f-403e-89f0-b1e528b26000.html,,,,,, Chromium acetate,17593-70-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1d1526a-4d0c-4af9-9c2a-94b53031148e/documents/4ae3a2c7-5d1e-4e94-b4b0-56cafb1ead0d_e18125b2-773f-403e-89f0-b1e528b26000.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "Chromium chloride, basic",50925-66-1," Since Cr(OH)Cl2 will dissociate in water or if ingested, it is considered valid to assess chloride ion and chromium ion toxicity. In view of the wealth of information available on chromium and fluoride, no further animal testing can be justified. Regardless of the high Cr3+ doses, chromium(III) oxide did not cause any significant treatment-related changes in the general condition of animals, body weights, clinical biochemistry, haematology, or pathological examination. The lack of toxicity of chromium(III) oxide can be explained by the poor bioavailability of this water-insoluble chromium compound. Faeces of treated animals showed an intense green discoloration, indicating significant excretion of the substance into faeces. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6226be6-949d-429c-a37f-818432c45189/documents/41930450-7ba0-46b8-9560-95247caeb3e5_012bb46c-9c88-4489-93af-c51cfe3ffc5c.html,,,,,, "Chromium chloride, basic",50925-66-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6226be6-949d-429c-a37f-818432c45189/documents/41930450-7ba0-46b8-9560-95247caeb3e5_012bb46c-9c88-4489-93af-c51cfe3ffc5c.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"44,000 mg/m3",,rat "Chromium chloride, basic",50925-66-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6226be6-949d-429c-a37f-818432c45189/documents/41930450-7ba0-46b8-9560-95247caeb3e5_012bb46c-9c88-4489-93af-c51cfe3ffc5c.html,Chronic toxicity – systemic effects,oral,NOAEL,0.36 mg/kg bw/day,,other:Human studies - WHO Guidelines for Drinking-Water Quality "Chromium chloride, basic",50925-66-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6226be6-949d-429c-a37f-818432c45189/documents/41930450-7ba0-46b8-9560-95247caeb3e5_012bb46c-9c88-4489-93af-c51cfe3ffc5c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"44,000 mg/m3",no adverse effect observed,rat "Chromium chloride, basic",50925-66-1," Extensive testing has been performed on chromium and fluoride salts. Other than where there is corrosivity, chromium II is not considered acutely toxic. The acute toxic effects and potential for irritation depend very much on the counter ions and pH. Salts with an extreme pH will be strongly irritant and perhaps corrosive to skin, and as such, will cause damage to skin, gastro-intestinal tract and respiratory system. Chromium fluoride as supplied is acidic and may induce local effects if tested on animals; performing new animal tests is not considered appropriate.   Sodium fluoride is soluble in water and has been tested for acute oral toxicity; in one study, all animals died at 2000 mg/kg, but there was no mortality at 200 mg/kg. A second study reported an LD50 of just over 200 mg/kg. The primary sources of these data are unknown, but the same figures appear in the sodium fluoride REACH dossier and can be considered reliable. [Ref 1].   One reliable primary reference suggested an LD50 of 253 mg/kg and is within the range of other tests [ref 2]. As a result of these studies, sodium fluoride is classified as Acute Tox 3. As sodium is itself not hazardous at this sort of concentration, the toxicity is considered due to soluble fluoride ions. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6226be6-949d-429c-a37f-818432c45189/documents/5d794ef0-17e6-4fbc-ac8f-550be251cf9a_012bb46c-9c88-4489-93af-c51cfe3ffc5c.html,,,,,, "Chromium chloride, basic",50925-66-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6226be6-949d-429c-a37f-818432c45189/documents/5d794ef0-17e6-4fbc-ac8f-550be251cf9a_012bb46c-9c88-4489-93af-c51cfe3ffc5c.html,,oral,LD50,230 mg/kg bw,adverse effect observed, Chromium diboride,12007-16-8," In an acute oral toxicity study in rats conducted according to OECD 423, the target substance Chromium diboride showed no adverse effects at the limit dose of 2000 mg/kg bw. Hence, the LD50 value is considered to be greater than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cc52c98-ec06-47c9-a236-1ff1682b9860/documents/121f456e-f70c-4f5d-a773-c2a78620e932_430e2bf6-d471-475c-af9e-4755c09643ec.html,,,,,, Chromium (III) hydroxynitrate,12158-37-1," Regardless of the high Cr3+ doses, chromium(III) oxide did not cause any significant treatment-related changes in the general condition of animals, body weights, clinical biochemistry, haematology, or pathological examination. The lack of toxicity of chromium(III) oxide can be explained by the poor bioavailability of this water-insoluble chromium compound. Faeces of treated animals showed an intense green discoloration, indicating significant excretion of the substance into faeces. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/deb674e3-23f1-49e0-b6b3-51d86ae1a676/documents/20704ad7-cc10-453f-b5e9-3daff64d6a37_1e0e89ca-d455-42e5-bbbb-6d8ef2c07102.html,,,,,, Chromium (III) hydroxynitrate,12158-37-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/deb674e3-23f1-49e0-b6b3-51d86ae1a676/documents/20704ad7-cc10-453f-b5e9-3daff64d6a37_1e0e89ca-d455-42e5-bbbb-6d8ef2c07102.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat Chromium (III) hydroxynitrate,12158-37-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/deb674e3-23f1-49e0-b6b3-51d86ae1a676/documents/20704ad7-cc10-453f-b5e9-3daff64d6a37_1e0e89ca-d455-42e5-bbbb-6d8ef2c07102.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"44,000 mg/m3",,rat Chromium (III) hydroxynitrate,12158-37-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/deb674e3-23f1-49e0-b6b3-51d86ae1a676/documents/20704ad7-cc10-453f-b5e9-3daff64d6a37_1e0e89ca-d455-42e5-bbbb-6d8ef2c07102.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"44,000 mg/m3",no adverse effect observed,rat Chromium (III) hydroxynitrate,12158-37-1," From extensive work on chromium III salts, there is no evidence of acute toxicity. Some corrosive salts will cause harm at high concentrations, but this is not considered to be a toxic effect. In view of the wealth of data on chromium salts, no further animal testing is justifed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/deb674e3-23f1-49e0-b6b3-51d86ae1a676/documents/56129bd2-3c04-47d9-8aeb-52d71a93ea7d_1e0e89ca-d455-42e5-bbbb-6d8ef2c07102.html,,,,,, Chromium (III) hydroxynitrate,12158-37-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/deb674e3-23f1-49e0-b6b3-51d86ae1a676/documents/56129bd2-3c04-47d9-8aeb-52d71a93ea7d_1e0e89ca-d455-42e5-bbbb-6d8ef2c07102.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Chromium hydroxide sulphate,12336-95-7,"Regardless of the high Cr3+ doses, chromium(III) oxide did not cause any significant treatment-related changes in the general condition of animals, body weights, clinical biochemistry, haematology, or pathological examination. Chromium III and sulphates are found naturally in food and water.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fadef273-49fa-4d3e-994a-b8897c3d2907/documents/b29c33e3-dce2-46c8-99d8-13208369a3fa_545e3d7d-006d-4607-b030-4aeafcfcf21b.html,,,,,, Chromium hydroxide sulphate,12336-95-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fadef273-49fa-4d3e-994a-b8897c3d2907/documents/b29c33e3-dce2-46c8-99d8-13208369a3fa_545e3d7d-006d-4607-b030-4aeafcfcf21b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat Chromium hydroxide sulphate,12336-95-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fadef273-49fa-4d3e-994a-b8897c3d2907/documents/b29c33e3-dce2-46c8-99d8-13208369a3fa_545e3d7d-006d-4607-b030-4aeafcfcf21b.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,17 mg/m3,,rat Chromium hydroxide sulphate,12336-95-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fadef273-49fa-4d3e-994a-b8897c3d2907/documents/b29c33e3-dce2-46c8-99d8-13208369a3fa_545e3d7d-006d-4607-b030-4aeafcfcf21b.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"44,000 mg/m3",no adverse effect observed,rat Chromium hydroxide sulphate,12336-95-7," From extensive work on chromium III salts, there is no evidence of acute toxicity. Some corrosive salts will cause harm at high concentrations, but this is not considered to be a toxic effect. In view of the wealth of data on chromium salts, no further animal testing is justifed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fadef273-49fa-4d3e-994a-b8897c3d2907/documents/8eb8749a-f9e2-4aec-aca5-2ca7eac22b9d_545e3d7d-006d-4607-b030-4aeafcfcf21b.html,,,,,, Chromium hydroxide sulphate,12336-95-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fadef273-49fa-4d3e-994a-b8897c3d2907/documents/8eb8749a-f9e2-4aec-aca5-2ca7eac22b9d_545e3d7d-006d-4607-b030-4aeafcfcf21b.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Chromium iron oxide,12737-27-8," It is concluded that the pigment was well tolerated and that no signs of systemic toxicity whatsoever were observed in rats when administered at a dose of 1000 mg/kg bw/day for up to 28 days. Either no or only marginal increases in Cr and Fe plasma concentrations were observed, and only a minor fraction (<0.002%) of the total administered dose of Cr and Fe was collected via urine, documenting the lack of bioavailability of this pigment. The no observed adverse effect level (NOAEL) in rats is 1000 mg/kg/day.   In a 90 -day repeated dose toxicity by inhalation study, rats were exposed via nose-only inhalation towards aerosol concentrations of 0.6, 2.5 and 10 mg/m³ of chromium iron oxide. All animals survived the test period and were euthanized at scheduled dates. Effects indicating local or systemic toxicity were not observed. Sex-specific differences were not detected. The NOAEC was considered to be above the highest concentration of 10 mg/m³ (the concentration at or above the onset of lung overload, thus constituting the maximum tolerated concentration). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3686c54c-3929-4a3e-8cef-ad4c03602e82/documents/IUC5-9c9c5a36-426c-408b-9770-638f8a2afc6d_44bb63ea-dfca-4ff2-98fc-d82cb421e6af.html,,,,,, Chromium iron oxide,12737-27-8,"Acute oral toxicity: LD50 > 5000 mg/kg bw (OECD 423 (2001); GLP compliant; female rats)Acute toxicity, inhalation: LC50 >5.01 mg/L air. MMAD: 3.656 µm (GSD: 3.08) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study fulfils the rquirements for acute oral toxicity under REACH (Regulation (EC) 1907/2006). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3686c54c-3929-4a3e-8cef-ad4c03602e82/documents/IUC5-57a1a805-718c-4c0c-a427-17a55114bb26_44bb63ea-dfca-4ff2-98fc-d82cb421e6af.html,,,,,, Chromium triacetate,1066-30-4,"NOAEL (90-d oral, rat) >= 2015 mg/kg bw/dayNOAEL (90-d oral, mouse) >= 4342 mg/kg bw/dayLOAEC, local  (90-d, inhalation, rat) = 21 mg/m³NOAEC, systemic (90-d, inhalation, rat) = 210 mg/m³NOAEL, dermal, systemic (extrapolation from 90-d oral rat) >= 2015 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d408189-ad48-4d93-9591-4134808b8820/documents/IUC5-bf9bb342-03f0-4803-809b-986f3eeaad1a_96b00693-102f-4dca-a1d7-41bcd293018a.html,,,,,, Chromium triacetate,1066-30-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d408189-ad48-4d93-9591-4134808b8820/documents/IUC5-bf9bb342-03f0-4803-809b-986f3eeaad1a_96b00693-102f-4dca-a1d7-41bcd293018a.html,Repeated dose toxicity – local effects,inhalation,LOAEC,21 mg/m3,adverse effect observed,rat Chromium triacetate,1066-30-4,"LD50 (oral, rat) > 5000 mg/kg bwLD50 (dermal, rat) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d408189-ad48-4d93-9591-4134808b8820/documents/IUC5-a8cdf90a-e52b-4d7b-9ebd-441a7f0b888d_96b00693-102f-4dca-a1d7-41bcd293018a.html,,,,,, Chromium trichloride,10025-73-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3e78519-8a4d-4f7e-bf3b-40696915d7b4/documents/0b788727-5476-48c6-9525-1339e23f9459_9a441040-fcad-46f6-a6c4-ed08926274e5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,21.3 mg/kg bw/day,,rat Chromium trichloride,10025-73-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3e78519-8a4d-4f7e-bf3b-40696915d7b4/documents/0b788727-5476-48c6-9525-1339e23f9459_9a441040-fcad-46f6-a6c4-ed08926274e5.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15.4 mg/m3,adverse effect observed,rat Chromium trichloride,10025-73-7,acute oral toxicity to rats: LD50 1568 mg/kg bwacute dermal toxicity to rats: LD50 >2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3e78519-8a4d-4f7e-bf3b-40696915d7b4/documents/c77f55e7-933f-450d-9de8-c76d5402ff0a_9a441040-fcad-46f6-a6c4-ed08926274e5.html,,,,,, Chromium trichloride,10025-73-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3e78519-8a4d-4f7e-bf3b-40696915d7b4/documents/c77f55e7-933f-450d-9de8-c76d5402ff0a_9a441040-fcad-46f6-a6c4-ed08926274e5.html,,oral,LD50,"1,568 mg/kg bw",adverse effect observed, Chromium trifluoride,7788-97-8," Since CrF3 will dissociate in water or if ingested, it is considered valid to assess fluoride ion and chromium ion toxicity. In view of the wealth of information available on chromium and fluoride, no further animal testing can be justified. The toxicity to fluoride has been used to set DNELs. However, despite toxicity to fluoride being reported, conclusions in risk assessments by the European Chemicals Bureau, CICAD and WHO, classification based on chronic toxicity is not required Regardless of the high Cr3+ doses, chromium(III) oxide did not cause any significant treatment-related changes in the general condition of animals, body weights, clinical biochemistry, haematology, or pathological examination. The lack of toxicity of chromium(III) oxide can be explained by the poor bioavailability of this water-insoluble chromium compound. Faeces of treated animals showed an intense green discoloration, indicating significant excretion of the substance into faeces. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d9779375-a2e2-4291-8571-c788df8e6d1d/documents/4e2f019a-7a79-48f7-83e4-1f8cb5b13f0f_8f36b129-6cba-49e8-8575-e1e2e0785e90.html,,,,,, Chromium trifluoride,7788-97-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d9779375-a2e2-4291-8571-c788df8e6d1d/documents/4e2f019a-7a79-48f7-83e4-1f8cb5b13f0f_8f36b129-6cba-49e8-8575-e1e2e0785e90.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"44,000 mg/m3",,rat Chromium trifluoride,7788-97-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d9779375-a2e2-4291-8571-c788df8e6d1d/documents/4e2f019a-7a79-48f7-83e4-1f8cb5b13f0f_8f36b129-6cba-49e8-8575-e1e2e0785e90.html,Chronic toxicity – systemic effects,oral,NOAEL,0.36 mg/kg bw/day,,other:Human studies - WHO Guidelines for Drinking-Water Quality Chromium trifluoride,7788-97-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d9779375-a2e2-4291-8571-c788df8e6d1d/documents/4e2f019a-7a79-48f7-83e4-1f8cb5b13f0f_8f36b129-6cba-49e8-8575-e1e2e0785e90.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"44,000 mg/m3",no adverse effect observed,rat Chromium trifluoride,7788-97-8," Extensive testing has been performed on chromium and fluoride salts. Other than where there is corrosivity, chromium II is not considered acutely toxic. The acute toxic effects and potential for irritation depend very much on the counter ions and pH. Salts with an extreme pH will be strongly irritant and perhaps corrosive to skin, and as such, will cause damage to skin, gastro-intestinal tract and respiratory system. Chromium fluoride as supplied is acidic and may induce local effects if tested on animals; performing new animal tests is not considered appropriate.   Sodium fluoride is soluble in water and has been tested for acute oral toxicity; in one study, all animals died at 2000 mg/kg, but there was no mortality at 200 mg/kg. A second study reported an LD50 of just over 200 mg/kg. The primary sources of these data are unknown, but the same figures appear in the sodium fluoride REACH dossier and can be considered reliable. [Ref 1].   One reliable primary reference suggested an LD50 of 253 mg/kg and is within the range of other tests [ref 2]. As a result of these studies, sodium fluoride is classified as Acute Tox 3. As sodium is itself not hazardous at this sort of concentration, the toxicity is considered due to soluble fluoride ions. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9779375-a2e2-4291-8571-c788df8e6d1d/documents/2a3d6252-79bf-4648-b5b4-6cfb0dbe552f_8f36b129-6cba-49e8-8575-e1e2e0785e90.html,,,,,, Chromium trifluoride,7788-97-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9779375-a2e2-4291-8571-c788df8e6d1d/documents/2a3d6252-79bf-4648-b5b4-6cfb0dbe552f_8f36b129-6cba-49e8-8575-e1e2e0785e90.html,,oral,LD50,230 mg/kg bw,adverse effect observed, Chromium triformate,27115-36-2," Regardless of the high Cr3+ doses, chromium(III) oxide did not cause any significant treatment-related changes in the general condition of animals, body weights, clinical biochemistry, haematology, or pathological examination. Formic acid and associated salts are found in many foods and are formed in animal and plant cells as a metabolite. There is no toxicity theshold for repeated exposure in humans. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8698956b-68ff-4fe9-a711-9cef434053a5/documents/dd73c7ee-5a27-4efb-92f9-3685a0755447_fecd7330-10dd-4f7f-9cd4-696724972af0.html,,,,,, Chromium triformate,27115-36-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8698956b-68ff-4fe9-a711-9cef434053a5/documents/dd73c7ee-5a27-4efb-92f9-3685a0755447_fecd7330-10dd-4f7f-9cd4-696724972af0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat Chromium triformate,27115-36-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8698956b-68ff-4fe9-a711-9cef434053a5/documents/dd73c7ee-5a27-4efb-92f9-3685a0755447_fecd7330-10dd-4f7f-9cd4-696724972af0.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"44,000 mg/m3",,rat Chromium triformate,27115-36-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8698956b-68ff-4fe9-a711-9cef434053a5/documents/dd73c7ee-5a27-4efb-92f9-3685a0755447_fecd7330-10dd-4f7f-9cd4-696724972af0.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"44,000 mg/m3",no adverse effect observed,rat Chromium triformate,27115-36-2," From extensive work on chromium III salts, there is no evidence of acute toxicity. Some corrosive salts will cause harm at high concentrations, but this is not considered to be a toxic effect. Although formic acid salts appear to be of low acute toxicity, the results were described as being dfepending on pH and availability of H+ ions.   Chromium triformate is supplied in acidic medium and classification as Acute Tox 4 is prudent.   In view of the wealth of data on chromium salts and formaate, no further animal testing is justified. It is accepted that there is no dermal absorption of metal salts such as chromium III from dermal contact.   The low oral toxicity also suggests low biological impact from contact with chromium III.  It is not considered to be justified to perform further animal tests. Skin penetration experiments on chromium chloride and chromium sulfate (1.2% chromium labelled with 51Cr) with skin chambers glued to the skin of normal volunteers. These chambers were removed at 6, 12, or 24 hours and analysis for radioactive chromium was performed at the site of the chamber as well as in the underlying epidermis and dermis. As no label was found in the lower levels of skin, it was concluded that chromium(III) salts did not permeate through the intact epidermis. Some blood samples and 24-h urine were also examined, and no radioactive chromium was detected.[Mali JWH, Van Kooten WJ, Van Neer CJ (1963) Some aspects of the behaviour of chromium compounds in the skin. Journal of Investigative Dermatology, 41:111–122]. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8698956b-68ff-4fe9-a711-9cef434053a5/documents/5f32be3d-40cb-4bb6-81f9-19c6469b3517_fecd7330-10dd-4f7f-9cd4-696724972af0.html,,,,,, Chromium trinitrate,13548-38-4,"Oral Repeated dose toxicity A study was conducted to evaluate the toxicity of chromium trichloride in rats exposed to 0, 5, 25, 50, or 100 mg Cr/kg bw in the diet for 20 weeks (estimated to correspond to 0.35 – 7 mg/kg bw). No morphological changes of liver and renal damage were observed based on histopathological examination of kidneys and did not result in significant alterations in body weight gain at level of 7 mg chromium/kg bw. Moreover no alterations in testes or epididymis weights were observed in rats at the highest dose. Therefore, the no-observed-adverse-effects-level (NOAEL) of chromium trichloride is estimated to be 7 mg chromium (III)/kg bw/day. As both, chromium trichloride and chromium trinitrate are very soluble chromium(III) compounds and neither chloride nor nitrate are associated with repeated dose toxicity, a read-across from chromium trichloride to chromium trinitrate is justified and sufficient for hazard and risk assessment. The NOAEL value can be converted to a NOAEL of >32 mg/kg bw/d based on molecular mass of chromium trinitrate. Repeated dose inhalative toxicity No systemic toxicity was observed in rats following a 13-week nose-only inhalation study of basic chromium sulphate, a surrogate substance to chromium trinitrate, also being a very soluble chromium(III) compound. Pathological findings were observed in the respiratory tract and are associated with the deposition of inhaled particulate material. The LOAEC, based on chromium trinitrate nonahydrate in this study was established at 23.1 mg/m3 air (3 mg/m3 Cr). Similar physical inflammation reactions were observed in a 4 - 6 week inhalative study with chromium trinitrate applied to rabbits. In this subacute study also no systemic toxicity was observed but only a limited number of parameters were followed as the study focused on the investigation of lung tissue of rabbits by inhalative exposure. Thus, this study, although performed on the reference substance, is considered supportive and the subchronic study on the surrogate substance is used as key study for inhalative repeated dose toxicity. Repeated dose dermal toxicity No data is available on repeated dose dermal toxicity of chromium trinitrate or other chromium(III) compounds. As dermal absorption is very limited (see toxicokinetic assessment) such a study is not required as systemic toxicity is already assessed by the oral study above. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2336628-3237-4591-a724-6a5813fa3c8a/documents/8e9ce9a3-624f-4e69-9d2a-8db3ab132c91_f3f0ddbd-687f-4832-9e7f-245bc6153c7e.html,,,,,, Chromium trinitrate,13548-38-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2336628-3237-4591-a724-6a5813fa3c8a/documents/8e9ce9a3-624f-4e69-9d2a-8db3ab132c91_f3f0ddbd-687f-4832-9e7f-245bc6153c7e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,32 mg/kg bw/day,,rat Chromium trinitrate,13548-38-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2336628-3237-4591-a724-6a5813fa3c8a/documents/8e9ce9a3-624f-4e69-9d2a-8db3ab132c91_f3f0ddbd-687f-4832-9e7f-245bc6153c7e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,23.1 mg/m3,, Chromium trinitrate,13548-38-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2336628-3237-4591-a724-6a5813fa3c8a/documents/8e9ce9a3-624f-4e69-9d2a-8db3ab132c91_f3f0ddbd-687f-4832-9e7f-245bc6153c7e.html,Repeated dose toxicity – local effects,inhalation,LOAEC,23.1 mg/m3,adverse effect observed,rat Chromium trinitrate,13548-38-4,"Acute LD50 (oral, rat): 2363 mg/kg bw (as average of 2 results - 1475 mg/kg bw and 3250 mg/kg bw - in a weight of evidence approach)Acute LC50 (inhal., rat): < 4.58 g/m³ (7/10 animals died during the course of the study --> classified as acute inhalative toxic, category IV according to CLP) 2 publications reporting on the acute toxicity of chromium nitrate nonahydrate were used in a weight of evidence approach and the average LD50 is used for hazard and risk assessment. Only one inhalative study available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2336628-3237-4591-a724-6a5813fa3c8a/documents/9e5e2044-f67a-45b3-b587-e4272cd16121_f3f0ddbd-687f-4832-9e7f-245bc6153c7e.html,,,,,, Chromium trinitrate,13548-38-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2336628-3237-4591-a724-6a5813fa3c8a/documents/9e5e2044-f67a-45b3-b587-e4272cd16121_f3f0ddbd-687f-4832-9e7f-245bc6153c7e.html,,oral,LD50,"2,363 mg/kg bw",no adverse effect observed, Chromium trinitrate,13548-38-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2336628-3237-4591-a724-6a5813fa3c8a/documents/9e5e2044-f67a-45b3-b587-e4272cd16121_f3f0ddbd-687f-4832-9e7f-245bc6153c7e.html,,inhalation,LC50,"4,580 mg/m3",adverse effect observed, Chromium trioleate,21178-63-2,"Oral:LD50 > 2000 mg/kg bw (rat, males and females); BASF AG, 1990 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ffe1b1f0-7575-4116-b6af-b0f68cbd297c/documents/IUC5-6246899a-e7d1-4e48-9d8a-a23b2b6cf947_1fa1ffee-d767-409a-8d3a-88522b4e63fc.html,,,,,, Chromium tris((2-ethylhexanoate),3444-17-5," Oral administration: A study similar to OECD 408 guideline (Rhodes, 2005) was conducted on the source substance Chromium picolinate monohydrate with rats and mice. Subchronic exposure to the substance did not cause any toxic effects in rats and mice: all animals survived, no change of body weight, food consumption, hematology, clinical chemistry, pathology organ weight and histopathology were recorded compared to control animals. After molecular weight's correction, the NOAELS were estimated to be: rats = 4683 mg/Kg, mice = 10089 mg/Kg. Inhalation exposure: A short-term repeated dose toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely based on physical form of the substance: the pure substance is a sticky paste. Dermal exposure: A subchronic or chronic dermal study is not available. The oral NOAEL can be extrapolated to the dermal route, since dermal absorption is expected to be in the same order of magnitude as oral absorption (very low absorption). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eba4f04c-b815-464d-9a0d-bb5874613b90/documents/1dc4218d-5b21-4f8a-99c0-311da5c63b9a_ac8a775c-2547-4161-bbf0-131fd0f9179c.html,,,,,, Chromium tris((2-ethylhexanoate),3444-17-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eba4f04c-b815-464d-9a0d-bb5874613b90/documents/1dc4218d-5b21-4f8a-99c0-311da5c63b9a_ac8a775c-2547-4161-bbf0-131fd0f9179c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"4,683 mg/kg bw/day",,rat Chromium tris((2-ethylhexanoate),3444-17-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eba4f04c-b815-464d-9a0d-bb5874613b90/documents/1dc4218d-5b21-4f8a-99c0-311da5c63b9a_ac8a775c-2547-4161-bbf0-131fd0f9179c.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"4,683 mg/kg bw/day",,rat Chromium tris((2-ethylhexanoate),3444-17-5," ORAL ROUTE According to the key study (Richeux, 2017) conducted in accordance with the O.E.C.D. test guideline n° 423, the LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. DERMAL ROUTE According to the key study (Richeux, 2017) conducted in accordance with the O.E.C.D. test guideline n°402, the LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in the rat. INHALATION ROUTE The pure substance is a paste. As a consequence, the study need not be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and the possibility of exposure to aerosols, particles or droplets of an inhalable size. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eba4f04c-b815-464d-9a0d-bb5874613b90/documents/b7e79b7f-1b61-4c1e-82e6-545c0e0593c9_ac8a775c-2547-4161-bbf0-131fd0f9179c.html,,,,,, Chromium tris((2-ethylhexanoate),3444-17-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eba4f04c-b815-464d-9a0d-bb5874613b90/documents/b7e79b7f-1b61-4c1e-82e6-545c0e0593c9_ac8a775c-2547-4161-bbf0-131fd0f9179c.html,,oral,LD50,"> 2,000 ",no adverse effect observed, Chromium tris((2-ethylhexanoate),3444-17-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eba4f04c-b815-464d-9a0d-bb5874613b90/documents/b7e79b7f-1b61-4c1e-82e6-545c0e0593c9_ac8a775c-2547-4161-bbf0-131fd0f9179c.html,,dermal,,"> 2,000 ",no adverse effect observed, Chromium tris(dihydrogen phosphate),27096-04-4," Regardless of the high Cr3+ doses, chromium(III) oxide did not cause any significant treatment-related changes in the general condition of animals, body weights, clinical biochemistry, haematology, or pathological examination. The lack of toxicity of chromium(III) oxide can be explained by the poor bioavailability of this water-insoluble chromium compound. Faeces of treated animals showed an intense green discoloration, indicating significant excretion of the substance into faeces. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c36b7cf5-6465-4f63-a240-a9084da3d454/documents/3a1a23c7-9291-451d-95c1-d304e8742164_935fb8e7-b0bb-4c74-918c-4681d2cc7530.html,,,,,, Chromium tris(dihydrogen phosphate),27096-04-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c36b7cf5-6465-4f63-a240-a9084da3d454/documents/3a1a23c7-9291-451d-95c1-d304e8742164_935fb8e7-b0bb-4c74-918c-4681d2cc7530.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat Chromium tris(dihydrogen phosphate),27096-04-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c36b7cf5-6465-4f63-a240-a9084da3d454/documents/3a1a23c7-9291-451d-95c1-d304e8742164_935fb8e7-b0bb-4c74-918c-4681d2cc7530.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"44,000 mg/m3",,rat Chromium tris(dihydrogen phosphate),27096-04-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c36b7cf5-6465-4f63-a240-a9084da3d454/documents/3a1a23c7-9291-451d-95c1-d304e8742164_935fb8e7-b0bb-4c74-918c-4681d2cc7530.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"44,000 mg/m3",no adverse effect observed,rat Chromium tris(dihydrogen phosphate),27096-04-4," From extensive work on chromium III salts, there is no evidence of acute toxicity. Some corrosive salts will cause harm at high concentrations, but this is not considered to be a toxic effect. In view of the wealth of data on chromium salts, no further animal testing is justifed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c36b7cf5-6465-4f63-a240-a9084da3d454/documents/7024ab9b-9364-4ff9-9fc6-bbb945701c01_935fb8e7-b0bb-4c74-918c-4681d2cc7530.html,,,,,, Chromium tris(dihydrogen phosphate),27096-04-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c36b7cf5-6465-4f63-a240-a9084da3d454/documents/7024ab9b-9364-4ff9-9fc6-bbb945701c01_935fb8e7-b0bb-4c74-918c-4681d2cc7530.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Chromium yttrium oxide (1:1:3),12182-76-2,"Acute toxicity: oral (Dreher 2022) Under the conditions of this study, the LD50 of the test material was found to be >2000 mg/kg bw in rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c40e72f5-0446-468b-8440-0531ac204238/documents/14c7d610-66b4-4578-a6ad-cda35ca4888f_6ee42b16-ae0b-4166-921e-470967048ab1.html,,,,,, Chromium yttrium oxide (1:1:3),12182-76-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c40e72f5-0446-468b-8440-0531ac204238/documents/14c7d610-66b4-4578-a6ad-cda35ca4888f_6ee42b16-ae0b-4166-921e-470967048ab1.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Chromium(3+) neodecanoate,68683-16-9, The substance is not toxic via oral route ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bbd8450-e46a-4fe8-869e-fb20c7022e2e/documents/c22190a9-84b9-4cb4-818c-4b8399c19e3e_2f716b13-5df6-4108-b12f-28d140381ba1.html,,,,,, Chromium(III) 4-oxopent-2-ene-2-olate,21679-31-2," Toxicité avec doses répétées par voie orale: Compte-tenu de sa solubilité dans l’eau d’environ 1.0 g/L, la substance à enregistrer: acétylacétonate de chrome (substance cible) se dissocie presque entièrement en espèces chargées en milieu aqueux (les deux substances sources): les anions organiques d’acétylacétone (aussi appelé 2,4-pentanedione) et les cations métalliques de chrome trivalents (Cr3+). Le tractus gastro-intestinal des mammifères (rats, souris, lapins) peut être considéré comme un milieu aqueux (salives, suc digestifs etc.) et la méthode d’évaluation de la toxicité avec doses répétées par voie orale de la substance à enregistrer peut donc être basée sur une approche par références croisées (« Read across »), en considérant la toxicité avec doses répétées par voie orale de la partie organique et de la partie inorganique séparément dans un premier temps, et en conjonction par la suite pour l’évaluation finale.   Pour l’évaluation de la toxicité avec doses répétées par voie orale de la substance à enregistrer, la toxicité de sa partie organique (2,4-pentanedione) et de sa partie inorganique (chrome trivalent : Cr3+) ont donc été prises en compte en considérant la substance à enregistrer comme un mélange composé de sa partie organique (2,4 pentanedione) et de sa partie inorganique (le chrome). Etant donné que des données de toxicité aigüe par voie orale existent pour les 2 composants (2,4-pentanedione et fer) de ce mélange (acétylacétonate de chrome) et en vertu du règlement (CE) numéro 1272/2008 du parlement européen et du conseil relatif à la classification, à l'étiquetage et à l'emballage des substances et des mélanges (CLP regulation), section3.1.3.6.1., une approche similaire à celle de la formule d’additivité peut donc être utilisée. L’estimation de la toxicité avec doses répétées par voie orale peut se faite de la même manière que pour la toxicité aigüe (ETA) du mélange (acétylacétonate de chrome) est donc calculée à partir des valeurs d'ETA (ici remplacé par les DNSEO ou NOAEL) des composants à prendre en compte (2,4-pentanedione et chrome), à l'aide de la formule suivante: 100/ATEmix = ∑ n Ci/ATEi dans laquelle: ATEmix = estimation de la toxicité aiguë du mélange C i = concentration du composant i ( % m/m ou % v/v) i = composant individuel de 1 à n n = nombre de composants ETAi = estimation de la toxicité aiguë du composant i. La concentration de chacun des 2 composants dans le mélange a été calculée sur la base de leur contribution en masse. Pour ce faire, les masses moléculaires (MM) de l’acétylacétone (100.12 g/mole), du chrome (51.99 g/mole) et de l’acétylacétonate de chrome (349.32 g/mole) ont été utilisées. Ainsi, compte-tenu de la structure moléculaire de l’acétylacétone (C5H8O2) et de celle de l’acétylacétonate de chrome (Cr(C5H7O2)3), la concentration de chacun des 2 composants du mélange ont été calculée de la manière suivante : -       Concentration de l’acétylacétone dans le mélange : ((100.12 x 3)/349.32)*100 = 85.98% -       Concentration du chrome dans le mélange : (51.99/349.32)*100 = 14.88% Les données existantes sur la toxicité avec doses répétées par voie orale de l’acétylacétone (2,4-pentanedione) indiquent une DSENO (NOAEL) de 100 mg/kg de poids corporel/jour (OECD, 2001). En ce qui concerne les données de toxicité avec doses répétées par voie orale du chrome trivalent (Cr3+), une seule étude fiable existe, les essais ayant été effectués avec des rats femelles et mâles ayant ingérés de l'oxyde chromique (Cr2O3). La DSENO (NOAEL) retenue pour l’évaluation est celle obtenue avec les mâles et femelles et elle est de 1468 mg de Cr/kg de poids corporel/jour (Ivankovic and Preussman, 1975). En appliquant la formule d’additivité décrite ci-dessus, cette approche par références croisées permet donc de calculer une dose sans effet nocif observé de 115 mg/kg de poids corporel/jour envers les rats pour l'acétylacétonate de chrome.     Toxicité avec doses répétées par inhalation: Compte-tenu de sa solubilité dans l’eau d’environ 1.0 g/L, la substance à enregistrer: acétylacétonate de chrome (substance cible) se dissocie presque entièrement en espèces chargées (les deux substances sources): les anions organiques d’acétylacétone (aussi appelé 2,4-pentanedione) et les cations métalliques de chrome trivalents (Cr3+). La méthode d’évaluation de la toxicité avec doses répétées par inhalation de la substance à enregistrer peut donc être basée sur une approche par références croisées (« Read across »), en considérant la toxicité avec doses répétées par inhalation de la partie organique et de la partie inorganique séparément dans un premier temps, et en conjonction par la suite pour l’évaluation finale.   Les données existantes sur la toxicité avec doses répétées par inhalation des deux parties de la substance à enregistrer indiquent une LOEAC de 2711 mg/m3 chez des lapins exposés à de la 2,4-pentanedione par inhalation pendant une période de 14 semaines (Dodd et al., 1986) et une LOEAC de 1668 mg/m3 chez des rats exposés à de la 2,4-pentanedione par inhalation pendant 9 jours (Dodd et al., 1986). En ce qui concerne le chrome, une LOEAC de 4.4 mg/m3 a été établie chez des rats exposés à de l'oxyde chromique (Cr2O3) pendant une période de 13 semaines (Derelanko et al., 1999). La toxicité de la 2,4-pentanedione apparait donc négligeable comparée à celle du Chrome et pour l’évaluation de la toxicité avec doses répétées par inhalation de la substance à enregistrer, seule la toxicité de sa partie inorganique (le chrome) est donc considérée. Les indicateurs toxicologiques (LOEAC) de la substance à enregistrer ont ensuite été recalculés en utilisant un facteur de conversion qui tient compte de la contribution en masse de la partie inorganique de la substance à enregistrer par rapport à sa masse totale. Le calcul de ce facteur de conversion se base sur la comparaison de la masse moléculaire (MM) de la 2,4-pentanedione et du Chrome. L’acétylacétonate de chrome (Cr(C5H7O2)3) a une MM de 349.32 g/mole et le Chrome a une MM de 51.99 g/mole. Compte-tenu de la masse moléculaire des 2 substances, le facteur de conversion a été calculé de la manière suivante : 349.32/51.99 = 6.72. Il a donc ensuite été appliqué aux données toxicologiques existantes pour le Chrome pour dériver les données toxicologiques de la substance à enregistrer. Cela permet donc de calculer une LOEAC de 29.6 mg/m3 en ce qui concerne la toxicité avec doses répétées par inhalation pour la substance à enregistrer.   Toxicité avec doses répétées par voie cutanée: Compte-tenu de sa solubilité dans l’eau d’environ 1.0 g/L, la substance à enregistrer: acétylacétonate de chrome (substance cible) se dissocie presque entièrement en espèces chargées (les deux substances sources): les anions organiques d’acétylacétone (aussi appelé 2,4-pentanedione) et les cations métalliques de chrome trivalents (Cr3+). La méthode d’évaluation de la toxicité avec doses répétées par voie cutanée de la substance à enregistrer peut donc être basée sur une approche par références croisées (« Read across »), en considérant la toxicité avec doses répétées par voie cutanée de la partie organique et de la partie inorganique séparément dans un premier temps, et en conjonction par la suite pour l’évaluation finale.   Les données existantes sur la toxicité avec doses répétées par voie cutanée des deux parties de la substance à enregistrer indiquent une NOEAL de 244 mg/kg de poids corporel/jour chez des lapins exposés par occlusion pendant 9 jours (Ballantyne & Cawley 2001) alors qu’aucune données ne sont disponibles en ce qui concerne la toxicité avec doses répétées par voie cutanée pour le Chrome. Pour l’évaluation de la toxicité avec doses répétées par voie cutanée de la substance à enregistrer, seule la toxicité de sa partie organique (2,4-pentanedione) a donc été prise en compte. Les indicateurs toxicologiques (NOEAL) de la substance à enregistrer ont ensuite été recalculés en utilisant un facteur de conversion qui tient compte de la contribution en masse de la partie organique de la substance à enregistrer par rapport à sa masse totale. Le calcul de ce facteur de conversion se base sur la comparaison de la masse moléculaire (MM) de la 2,4-pentanedione et de l’acétylacétonate de chrome et prend en compte la structure moléculaire des 2 molécules. La 2,4-pentanedione (C5H8O2) a une MM de 100.12 g/mole et l’acétylacétonate de chrome (Cr(C5H7O2)3) a une MM de 349.32 g/mole. Compte-tenu de la structure moléculaire des 2 substances, le facteur de conversion a été calculé de la manière suivante : 349.32/(100.12 x 3) = 1.16. Il a donc ensuite été appliqué aux données toxicologiques existantes pour la 2,4-pentanedione pour dériver les données écotoxicologiques de la substance à enregistrer. Ceci permet donc de calculer une NOEAL de 284 mg/kg de poids corporel/jour en ce qui concerne la toxicité avec doses répétées par voie cutanée de la substance à enregistrer : l’acétylacétonate de Chrome. D'autre part, certains effets systémiques ont été mis en évidence après exposition par inhalation pour la partie organique de la substance à enregistrer (effets irritants, hémorragie, dégénération neuronale dans la région du cerveau, et effets/hémorragie dans la rate, le thymus et les ganglions lymphatiques) mais ces effets ne sont pas apparus suffisamment avérés pour mener au classement de la substance à enregistrer: acétylacétonate de Chrome.     Références : Ballantyne B, Cawley TJ (2001) Toxicology update: 2,4-Pentanedione. Journal of Applied Toxicology 21, 165–171. Derelanko MJ, Rinehart WE, Hilaski RJ, Thompson RB, Löser E (1999). Thirteen-week subchronic rat inhalation toxicity study with a recovery phase of trivalent chromium compounds, chromic oxide, and basic chromium sulfate. Toxicological Sciences, 52:278–288 Dodd DE, Garman RH, Pritts IM, Troup CM, Snellings WM, Ballantyne B (1986) 2,4- Pentanedione: 9-Day and 14-Week Vapor Inhalation Studies in Fischer-344 Rats. Fundamental and Applied Toxicology 7: 329-339. Ivankovic S Preussman R. (1975) Absence of toxic and carcinogenic effects after administrations of high doses of chronic oxide pigment in subacute and long term feeding experiments in rats. Food and Cosmetics Toxicology 13:347-351. OECD Organisation for Economic Co-operation and Development (2001). 2,4-Pentanedione. CAS N°: 123-54-6. SIDS Initial Assessment Report for SIAM 13 (Paris, France, in June) United Nations Environment Programme (UNEP) Publications, Nairobi, Kenya.82 p. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d224995c-d735-4a0b-b8d1-29f2f174dfb1/documents/69bdd325-756b-476e-8bdd-e17fbcbc7f6f_20d93f74-fd37-4902-9ecf-3410b321f4d7.html,,,,,, Chromium(III) 4-oxopent-2-ene-2-olate,21679-31-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d224995c-d735-4a0b-b8d1-29f2f174dfb1/documents/69bdd325-756b-476e-8bdd-e17fbcbc7f6f_20d93f74-fd37-4902-9ecf-3410b321f4d7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,115 mg/kg bw/day,,rat Chromium(III) 4-oxopent-2-ene-2-olate,21679-31-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d224995c-d735-4a0b-b8d1-29f2f174dfb1/documents/69bdd325-756b-476e-8bdd-e17fbcbc7f6f_20d93f74-fd37-4902-9ecf-3410b321f4d7.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,284 mg/kg bw/day,,rabbit Chromium(III) 4-oxopent-2-ene-2-olate,21679-31-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d224995c-d735-4a0b-b8d1-29f2f174dfb1/documents/69bdd325-756b-476e-8bdd-e17fbcbc7f6f_20d93f74-fd37-4902-9ecf-3410b321f4d7.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,29.6 mg/m3,,rat Chromium(III) 4-oxopent-2-ene-2-olate,21679-31-2," Toxicité aigüe par voie orale : Une étude fiable (R2 selon l’échelle de Klimisch, 1997) (Carpenter et al., 1974) conduite sur des rats exposés à de l’acétylacétonate de chrome par voie orale (gavage) indique une dose létale médiane (DL50) de 3360 mg/kg de poids corporel, démontrant l’innocuité de la substance à enregistrer par cette voie d’exposition.   Toxicité aigüe par inhalation : Une dérogation à l'obligation d'essais de toxicité aigüe par inhalation de la substance à enregistrer est invoquée selon l'annexe VIII du règlement REACH section 8.5.2., compte-tenu du fait que l'exposition des êtres humains est peu probable, la pression de vapeur de la substance à enregistrer étant considérée comme très faible (voir section 4.6 de ce dossier pour plus de détails sur la pression de vapeur de la substance à enregistrer). La substance à enregistrer est considérée comme n’ayant pas d’effet nocifs par cette voie d’exposition.   Toxicité aigüe par voie cutanée : Une étude fiable (R2 selon l’échelle de Klimisch, 1997) (Carpenter et al., 1974) conduite sur des souris exposés à de l’acétylacétonate de chrome par voie cutanée indique une dose létale médiane (DL50) de 6350 mg/kg de poids corporel, démontrant l’innocuité de la substance à enregistrer par cette voie d’exposition.     Références :   Carpenter C, Weil CS, Smyth HF (1974) Range-Finding Toxicity Data: List VIII. Toxicology and Applied Pharmacology 28: 313-319.   Klimisch H-J, Andreae M, Tillmann U (1997). A systematic approach for evaluating the quality of experimental toxicological and ecotoxicological data.Regulatory Toxicology and Pharmacology 25:1-7. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d224995c-d735-4a0b-b8d1-29f2f174dfb1/documents/846e1d9f-4a50-46cf-a4ec-bd3c9098a607_20d93f74-fd37-4902-9ecf-3410b321f4d7.html,,,,,, Chromium(III) 4-oxopent-2-ene-2-olate,21679-31-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d224995c-d735-4a0b-b8d1-29f2f174dfb1/documents/846e1d9f-4a50-46cf-a4ec-bd3c9098a607_20d93f74-fd37-4902-9ecf-3410b321f4d7.html,,oral,LD50,"3,360 mg/kg bw",no adverse effect observed, Chromium(III) 4-oxopent-2-ene-2-olate,21679-31-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d224995c-d735-4a0b-b8d1-29f2f174dfb1/documents/846e1d9f-4a50-46cf-a4ec-bd3c9098a607_20d93f74-fd37-4902-9ecf-3410b321f4d7.html,,dermal,LD50,"6,350 mg/kg bw",no adverse effect observed, "Cinchona officinalis, ext.",84776-27-2,The LD50 of the read across substance quinine for rats after oral application is 350.812 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17109f03-4d1a-49f9-9776-bec0ab9eaac4/documents/IUC5-39819ea1-a697-4d95-8734-2f8c8841ec04_bb4032f4-c71c-45dd-b5b8-06e7628ddb61.html,,,,,, "Cinchona officinalis, ext.",84776-27-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17109f03-4d1a-49f9-9776-bec0ab9eaac4/documents/IUC5-39819ea1-a697-4d95-8734-2f8c8841ec04_bb4032f4-c71c-45dd-b5b8-06e7628ddb61.html,,oral,LD50,350.82 mg/kg bw,adverse effect observed, Cinchonidine,485-71-2,The LD50 of the read across substance quinine sulphate for rats is 455.8 mg/kg bw (350.82 mg quinine/kg bw) after oral application. We conclude that cinchonidine which differs in a methoxy group has a similar LD50 value. The LD50 of cinchonidine after intraperitoneal injection is 206 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4617e489-9424-4b16-9926-d1a579f0bf15/documents/IUC5-c7a122cc-b7fe-452b-9526-455edecfdbfa_90c09338-7645-43de-8c4f-93719bce0aaa.html,,,,,, Cinchonidine,485-71-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4617e489-9424-4b16-9926-d1a579f0bf15/documents/IUC5-c7a122cc-b7fe-452b-9526-455edecfdbfa_90c09338-7645-43de-8c4f-93719bce0aaa.html,,oral,LD50,350.82 mg/kg bw,adverse effect observed, Cinchonine,118-10-5,The LD50 of the read across substance quinine sulphate for rats is 455.8 mg/kg bw (350.82 mg quinine/kg bw) after oral application. We conclude that cinchonine which differs in a methoxy group has a similar LD50 value. The LD50 of cinchonine after intraperitoneal injection is 152 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49b2cf8e-3f36-4422-ae16-7e4bc02fc3cd/documents/IUC5-af573dc1-fb92-4cc8-8303-f33adba2fbe6_5948bf0a-d85c-404a-b38e-77970ab5ef92.html,,,,,, Cinchonine,118-10-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49b2cf8e-3f36-4422-ae16-7e4bc02fc3cd/documents/IUC5-af573dc1-fb92-4cc8-8303-f33adba2fbe6_5948bf0a-d85c-404a-b38e-77970ab5ef92.html,,oral,LD50,350.82 mg/kg bw,adverse effect observed, Cinnamyl butyrate,103-61-7," Acute Oral Toxicity:  Acute oral toxicity dose was predicted based on OECD QSAR toolbox for target substance Cinnamyl butyrate (103-61-7) estimated to be 3331.84 mg/kg bw on rats,and the QSAR prediction done using the Danish (Q)SAR Databasefor target substance Cinnamyl butyrate (103-61-7) was estimated to be 3900 mg/kg bw on rats and for differentstudies available on target substance Cinnamyl butyrate (103-61-7) was considered to be >5000 mg/kg bw on rats and for the structurally similar read across substance Ethyl Butyrate (CAS No. 105-54-4) was considered to be 5000 mg/kg bw on rats and for Cinnamyl acetate (103-54-8) was considered to be 3300 mg/kg bw on rats. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation Cinnamyl butyrate (103-61-7) can be classified as category V of acute oral toxicity. Acute Dermal Toxicity: Acute dermal toxicity dose was predicted based on OECD QSAR toolbox for target substance Cinnamyl butyrate (103-61-7) estimated to be 5092.86 mg/kg bw on rabbits andfor differentstudies available on target substance Cinnamyl butyrate (103-61-7) was considered to be >5000 mg/kg bw on rabbits and for the structurally similar read across substance Ethyl Butyrate (CAS No. 105-54-4) was considered to be >2000 mg/kg bw on rabbits and and for Cinnamyl acetate (103-54-8) was considered to be > 5000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Cinnamyl butyrate (103-61-7) can be classified as category V of acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbc4f70c-c3cf-4a41-91d9-26efafdf617d/documents/46c1f146-96b7-4802-8711-3ea6beb93ffa_814ab4a7-f33d-4fcf-9825-e66b72caad78.html,,,,,, Cinnamyl butyrate,103-61-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbc4f70c-c3cf-4a41-91d9-26efafdf617d/documents/46c1f146-96b7-4802-8711-3ea6beb93ffa_814ab4a7-f33d-4fcf-9825-e66b72caad78.html,,oral,LD50,"3,331.84 mg/kg bw",no adverse effect observed, Cinnamyl butyrate,103-61-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbc4f70c-c3cf-4a41-91d9-26efafdf617d/documents/46c1f146-96b7-4802-8711-3ea6beb93ffa_814ab4a7-f33d-4fcf-9825-e66b72caad78.html,,dermal,LD50,"5,092.86 mg/kg bw",no adverse effect observed, "cis-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolane-4-ylmethyl methanesulphonate monohydrochloride",84145-27-7," Repeated dose toxicity - oral: In a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the test substance was administered daily to rats up to a dose level of 109 mg/kg body weight/day (100 mg eq/kg bw/day, OECD 422; Peter, 2017). The NOAEL is established as 100 mg eq/kg body weight/day for males and 30 mg eq/kg bw/day for females. The substance is therefore classified as STOT RE 2, according to CLP Regulation. Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0dd7fb08-dc7f-49d7-9a4d-5f3749cb03a2/documents/b2291184-a24f-42ef-a2a2-ac0d3ac6603d_aff4ca22-e183-4e2a-b7d1-a89ffb6ed431.html,,,,,, "cis-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolane-4-ylmethyl methanesulphonate monohydrochloride",84145-27-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0dd7fb08-dc7f-49d7-9a4d-5f3749cb03a2/documents/b2291184-a24f-42ef-a2a2-ac0d3ac6603d_aff4ca22-e183-4e2a-b7d1-a89ffb6ed431.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "cis-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolane-4-ylmethyl methanesulphonate monohydrochloride",84145-27-7," Acute toxicity: oral: In an acute oral toxicity study in female Crl:WI (Han) (SPF) rats, following the acute toxic class method in accordance with the OECD Guideline 423 and EU Method B.1 tris, the LD50 was established to be within the range of 300 - 2000 mg eq/kg. According to the OECD 423 guideline, the LD50 cut-off value was considered to be 500 mg eq/kg body weight (Latour, 2015). Acute toxicity: inhalation: In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For T001202, a key study is available for the dermal route of exposure. Therefore, an acute inhalation toxicity study should not be performed. Acute toxicity: dermal: In an acute dermal toxicity study in male and female Crl:WI (Han) (SPF) rats, following the standard acute method according to OECD Guideline 402 and EC method B.3, the LD50 was established to exceed 2000 mg eq/kg body weight (Latour, 2016). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0dd7fb08-dc7f-49d7-9a4d-5f3749cb03a2/documents/2d99a358-3d50-4385-9842-6b59157a1a43_aff4ca22-e183-4e2a-b7d1-a89ffb6ed431.html,,,,,, "cis-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolane-4-ylmethyl methanesulphonate monohydrochloride",84145-27-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0dd7fb08-dc7f-49d7-9a4d-5f3749cb03a2/documents/2d99a358-3d50-4385-9842-6b59157a1a43_aff4ca22-e183-4e2a-b7d1-a89ffb6ed431.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "cis-2-(2,4-dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolane-4-ylmethyl methanesulphonate monohydrochloride",84145-27-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0dd7fb08-dc7f-49d7-9a4d-5f3749cb03a2/documents/2d99a358-3d50-4385-9842-6b59157a1a43_aff4ca22-e183-4e2a-b7d1-a89ffb6ed431.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "cis-2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolane-4-ylmethyl benzoate",61397-56-6," Repeated dose toxicity - oral: In a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the test substance was administered daily to rats up to a dose level of 1000 mg/kg body weight/day (OECD 422; Mounier R, 2017). The NOAEL is established to be at least 1000 mg/kg body weight/day. The substance is therefore not classified as STOT RE according to the CLP Regulation. Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd9cefdc-f22f-42ef-8710-42043e0d7103/documents/86f15a50-1de2-4893-94be-8e135b12e968_b26e4956-03e5-4047-a26e-e217dbda1f59.html,,,,,, "cis-2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolane-4-ylmethyl benzoate",61397-56-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd9cefdc-f22f-42ef-8710-42043e0d7103/documents/86f15a50-1de2-4893-94be-8e135b12e968_b26e4956-03e5-4047-a26e-e217dbda1f59.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "cis-2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolane-4-ylmethyl benzoate",61397-56-6," Acute toxicity: In an acute oral toxicity study in female Crl:WI (Han) (SPF) rats, following the acute toxic class method in accordance with the OECD Guideline 423 and EU Method B.1 tris, the LD50 was established to be > 2000.0 mg/kg (Ott, 2006). Acute toxicity: Inhalation: In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For T001095, a study was considered however not deemed scientifically justified for the dermal route of exposure due to its low potential for a significant rate of absorption through the skin. Based on the fact that the inhalation route of exposure is not considered relevant in the risk assessment for human exposure and the addition of a waiver for the acute dermal toxicity testing, an acute inhalation toxicity study will not be performed. Acute toxicity: Dermal: In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For this substance, an acute dermal toxicity study was considered. However, this can be waived based on the fact that the substance does not meet the criteria for classification for acute toxicity or STOT SE by the oral route, and no systemic toxicity is observed in in vivo studies with dermal exposure. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd9cefdc-f22f-42ef-8710-42043e0d7103/documents/b021275f-a1c3-4986-9fab-b0a4b700ee23_b26e4956-03e5-4047-a26e-e217dbda1f59.html,,,,,, "cis-2-(bromomethyl)-2-(2,4-dichlorophenyl)-1,3-dioxolane-4-ylmethyl benzoate",61397-56-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd9cefdc-f22f-42ef-8710-42043e0d7103/documents/b021275f-a1c3-4986-9fab-b0a4b700ee23_b26e4956-03e5-4047-a26e-e217dbda1f59.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, cis-2-tert-butylcyclohexyl acetate,20298-69-5, Key study: NOAEL in 13 weeks sub-chronic study (according to OECD TG 408): >=423 mg /kg bw Supporting study: NOAEL in 10 wks extended repeated dose / reproscreen study (extended OECD TG 422): >=437 mg/kg bw ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98d1def6-14bf-4f6e-86e6-a2538fd86725/documents/IUC5-bb00199e-eb17-443c-82a6-fe130c58a623_88f2cad1-3365-41d6-a446-53a920cba667.html,,,,,, cis-2-tert-butylcyclohexyl acetate,20298-69-5, Acute oral toxicity: a study similar to OECD TG 401: LD50 = 4600 mg/kg bw (95% CI = 2700-7800) Acute inhalation toxicity LC50 route to route extrapolation = 11960 mg/m3 Acute dermal toxicity: a study similar to OECDTG402: LD50 => 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98d1def6-14bf-4f6e-86e6-a2538fd86725/documents/IUC5-58beb215-ca13-4621-94df-a9f95d3e3374_88f2cad1-3365-41d6-a446-53a920cba667.html,,,,,, cis-4-tert-butylcyclohexyl acetate,10411-92-4," NOAEL = 1000 mg/kg bw/day, i.e. 1005 or 980 mg/kg bw/day for males or females, respectively (OECD 407, GLP, K, rel.1) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b545938-400c-4745-b0f8-52cf6ba464e6/documents/ce803697-4732-4b30-88d3-64f449badeb9_25e4d63a-768b-42af-85ab-73ea2fc3d0fd.html,,,,,, cis-4-tert-butylcyclohexyl acetate,10411-92-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b545938-400c-4745-b0f8-52cf6ba464e6/documents/ce803697-4732-4b30-88d3-64f449badeb9_25e4d63a-768b-42af-85ab-73ea2fc3d0fd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,980 mg/kg bw/day,,rat cis-4-tert-butylcyclohexyl acetate,10411-92-4," - Acute toxicity: oral: 300 mg/kg bw < LD50 < 2000 mg/kg bw (OECD 420, GLP, K, rel. 1). - Acute toxicity: inhalation: waiver. - Acute toxicity: dermal: LD50 = 4680 mg/kg bw, read-across (similar to OECD 402, K; rel.2) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b545938-400c-4745-b0f8-52cf6ba464e6/documents/IUC5-54b392c7-3eed-4695-83fc-356e9a097f4a_25e4d63a-768b-42af-85ab-73ea2fc3d0fd.html,,,,,, cis-4-tert-butylcyclohexyl acetate,10411-92-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b545938-400c-4745-b0f8-52cf6ba464e6/documents/IUC5-54b392c7-3eed-4695-83fc-356e9a097f4a_25e4d63a-768b-42af-85ab-73ea2fc3d0fd.html,,oral,LD50,300 mg/kg bw,adverse effect observed, cis-4-tert-butylcyclohexyl acetate,10411-92-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b545938-400c-4745-b0f8-52cf6ba464e6/documents/IUC5-54b392c7-3eed-4695-83fc-356e9a097f4a_25e4d63a-768b-42af-85ab-73ea2fc3d0fd.html,,dermal,LD50,"4,680 mg/kg bw",no adverse effect observed, "Citric acid, nickel salt",22605-92-1,Oral:NOAEL = 7.02 mg/kg bw Trinickel dicitrateLOAEL = 21.1 mg/kg bw Trinickel dicitrateInhalation:NOAEC = 0.159 mg/m3 Trinickel dicitrateLOAEC = 0.368 mg/m3 Trinickel dicitrate ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b36099ff-6cd5-4242-b7d1-4244d1b7afdc/documents/IUC5-31010f7c-5c9f-4aec-96c7-16f349aa57a6_f0c4a651-8543-4e39-9fee-8a06f0859f07.html,,,,,, "Citric acid, nickel salt",22605-92-1,Oral:LD50 cut-off = 370 mg/kg bw Trinickel dicitrateDermal:LD50 > 1480 mg/kg bw Trinickel dicitrate ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b36099ff-6cd5-4242-b7d1-4244d1b7afdc/documents/IUC5-1ac529cf-5bff-4587-973d-33eee84b9042_f0c4a651-8543-4e39-9fee-8a06f0859f07.html,,,,,, Clemizole hydrochloride,1163-36-6," RTECS:         Registry of Toxic Effects of Chemical Substances RTECS Number: DD6730000 Acute toxicity data: Type of test:       LD50 - Lethal dose, 50 percent kill Route of exposure:       Oral Species observed:       Rodent - rat Dose / duration:       1950 mg/kg Toxic effects: Details of toxic effects not reported other than lethal dose value Reference: JAPMA8 Journal of the American Pharmaceutical Association, Scientific Edition. (Washington, DC) V.29 -49, 1940 -60. Volume (issue) / page / year: 49 / 18 / 1960   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0295268-84e6-4081-91e1-bab2bcfd63d3/documents/71bbeb5c-3a73-4f66-99fc-0629adf3b220_8d5271ec-ed20-46a8-98be-af7621a26bdc.html,,,,,, Clemizole hydrochloride,1163-36-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0295268-84e6-4081-91e1-bab2bcfd63d3/documents/71bbeb5c-3a73-4f66-99fc-0629adf3b220_8d5271ec-ed20-46a8-98be-af7621a26bdc.html,,oral,LD50,"1,950 mg/kg bw",no adverse effect observed, Clioquinol,130-26-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The data is K2 level as the data has been obtained from QSAR model considered by OECD. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The data is K2 level as the data has been obtained from an experimental study from the journal "" Toxicology"" .Based upon this available data it is expected that this chemical clioquinol does not exhibit repeated dose oral toxicity to dog. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6d55edf-2efe-4507-8f85-1470b6e58e96/documents/IUC5-004c54b0-e019-4108-9297-52b1df8a5d61_a2128d14-9fe9-421f-9247-5ed665205fb1.html,,,,,, Clioquinol,130-26-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6d55edf-2efe-4507-8f85-1470b6e58e96/documents/IUC5-004c54b0-e019-4108-9297-52b1df8a5d61_a2128d14-9fe9-421f-9247-5ed665205fb1.html,Short-term repeated dose toxicity – systemic effects,inhalation,,159.486 ,,rat Clioquinol,130-26-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6d55edf-2efe-4507-8f85-1470b6e58e96/documents/IUC5-004c54b0-e019-4108-9297-52b1df8a5d61_a2128d14-9fe9-421f-9247-5ed665205fb1.html,Chronic toxicity – systemic effects,oral,LOAEL,250 mg/kg bw/day,,dog Clioquinol,130-26-7," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on mice and guinea pigs for the test chemical. The LD50 value is 69 mg/kg bw. The study concluded that LD50 is between 50-300 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “category 3” for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity dose (LC50) was considered based on different studies conducted on rats and mice for the test chemical. The LC50 value is 407.2346 mg/L (407234.6 mg/m3). The study concluded that LC50 is >5 mg/L, for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute inhalation toxicity. Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6d55edf-2efe-4507-8f85-1470b6e58e96/documents/IUC5-db141764-262b-4da4-9d9a-9d77b1a12a77_a2128d14-9fe9-421f-9247-5ed665205fb1.html,,,,,, Clioquinol,130-26-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6d55edf-2efe-4507-8f85-1470b6e58e96/documents/IUC5-db141764-262b-4da4-9d9a-9d77b1a12a77_a2128d14-9fe9-421f-9247-5ed665205fb1.html,,oral,LD50,69 mg/kg bw,adverse effect observed, Clioquinol,130-26-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6d55edf-2efe-4507-8f85-1470b6e58e96/documents/IUC5-db141764-262b-4da4-9d9a-9d77b1a12a77_a2128d14-9fe9-421f-9247-5ed665205fb1.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Clioquinol,130-26-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6d55edf-2efe-4507-8f85-1470b6e58e96/documents/IUC5-db141764-262b-4da4-9d9a-9d77b1a12a77_a2128d14-9fe9-421f-9247-5ed665205fb1.html,,inhalation,LC50,407.235 ,no adverse effect observed, Clomipramine,303-49-1," Two acute oral toxicity values are available, as secondary source, for clomipramine: mouse, LD50, oral = 380 mg/kg rat, LD50, oral = 750 mg/kg The substance is classified as Acute Tox. 4 H302. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee9f59bf-bf28-40c3-a68a-c85765d17a3c/documents/1ea72aa3-3b84-4da3-8cfb-f1ec06c0bc31_f3bcb533-7347-4dc7-920e-3763454e5c95.html,,,,,, Clomipramine,303-49-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee9f59bf-bf28-40c3-a68a-c85765d17a3c/documents/1ea72aa3-3b84-4da3-8cfb-f1ec06c0bc31_f3bcb533-7347-4dc7-920e-3763454e5c95.html,,oral,LD50,380 mg/kg bw,adverse effect observed, "clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine",210880-92-5," Oral subchronic toxicity key; M-027268-01-1; subchronic (90 d, rat): NOAEL (oral) 27.9 mg/kg bw/day (males) and 34.0 mg/kg bw/day (females) key; M-036499-02-1; subchronic (90 d, dog): NOAEL (oral) 19.3 mg/kg bw/day (males) and 21.2 mg/kg bw/day (females) key; M-036542-01-1; subchronic (1 y, dog): NOAEL (oral) 36.3 mg/kg bw/day (males) and 40.1 mg/kg bw/day (females)   Oral chronic toxicity key; M-031986-05-1; chronic/carcinogenicity (2 y, rat): NOAEL (chronic, oral) 27.4 mg/kg bw/day (males) and 9.7 mg/kg bw/day (females) key; M-032363-03-1; carcinogenicity (78 weeks, mouse): NOAEL (chronic, oral) 47.2 mg/kg bw/day (males) and 65.1 mg/kg bw/day (females)   Dermal subacute toxicity key; M-027480-01-1; subacute (4 weeks, rat): NOAEL (dermal) 1000 mg/kg bw/day (females, males) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0130042-f76d-4923-9fd2-03e507044f91/documents/fbc51d81-2a7d-46d8-a141-83fd5019a6a5_90214193-ac4d-49ce-8820-c8b2e91b67e7.html,,,,,, "clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine",210880-92-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0130042-f76d-4923-9fd2-03e507044f91/documents/fbc51d81-2a7d-46d8-a141-83fd5019a6a5_90214193-ac4d-49ce-8820-c8b2e91b67e7.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine",210880-92-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0130042-f76d-4923-9fd2-03e507044f91/documents/fbc51d81-2a7d-46d8-a141-83fd5019a6a5_90214193-ac4d-49ce-8820-c8b2e91b67e7.html,Chronic toxicity – systemic effects,oral,NOAEL,9.7 mg/kg bw/day,,rat "clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine",210880-92-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0130042-f76d-4923-9fd2-03e507044f91/documents/fbc51d81-2a7d-46d8-a141-83fd5019a6a5_90214193-ac4d-49ce-8820-c8b2e91b67e7.html,Repeated dose toxicity – local effects,dermal,NOAEL,40 mg/cm2,no adverse effect observed,rat "clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine",210880-92-5," Oral (OECD 401), mouse: LD50: 389 mg/kg bw (males) and 465 mg/kg bw (females) Oral (DRF acute neurotoxicity, SS), rat: LD50: > 1216 mg/kg bw (males) and > 523 to < 1216 mg/kg bw (females) Inhalation (OECD 403, limit test), rat: LC50: > 5.54 mg/L air (analytical) Dermal (OECD 402, limit test), rat: LD50: > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0130042-f76d-4923-9fd2-03e507044f91/documents/9b3cebcc-46de-409e-9281-ae234134f796_90214193-ac4d-49ce-8820-c8b2e91b67e7.html,,,,,, "clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine",210880-92-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0130042-f76d-4923-9fd2-03e507044f91/documents/9b3cebcc-46de-409e-9281-ae234134f796_90214193-ac4d-49ce-8820-c8b2e91b67e7.html,,oral,LD50,389 mg/kg bw,adverse effect observed, "clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine",210880-92-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0130042-f76d-4923-9fd2-03e507044f91/documents/9b3cebcc-46de-409e-9281-ae234134f796_90214193-ac4d-49ce-8820-c8b2e91b67e7.html,,dermal,LD50,">=2,000 mg/kg bw",no adverse effect observed, "clothianidin (ISO); (E)-1-(2-chloro-1,3-thiazol-5-ylmethyl)-3-methyl-2-nitroguanidine",210880-92-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0130042-f76d-4923-9fd2-03e507044f91/documents/9b3cebcc-46de-409e-9281-ae234134f796_90214193-ac4d-49ce-8820-c8b2e91b67e7.html,,inhalation,LC50,>=5.54 mg/L,no adverse effect observed, Cobalt bis(2-ethylhexanoate),136-52-7,"Acute oral toxicityLD50(female rats)=3129 mg/kg bwAcute dermal toxicityConduct of an acute dermal toxicity study for cobalt bis(2-ethylhexanoate) is unjustified since dermal uptake is considered negligible (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006).Acute inhalation toxicityAccording to section 2, annex XI of regulation (EC) 1907/2006, the conduct of an acute toxicity study via inhalation for cobalt bis(2-ethylhexanoate) is omitted. The substance is a waxy solid which is not capable in creating an inhalable atmosphere, thus testing is technically not feasible. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1d25974-a88e-426a-af6c-752d3de79ada/documents/IUC5-ef278e35-0e69-463c-916f-12acf13f62f6_3d078166-19ea-4c2c-ba14-d044a452fde7.html,,,,,, Cobalt bis(2-ethylhexanoate),136-52-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1d25974-a88e-426a-af6c-752d3de79ada/documents/IUC5-ef278e35-0e69-463c-916f-12acf13f62f6_3d078166-19ea-4c2c-ba14-d044a452fde7.html,,oral,LD50,"3,129 mg/kg bw",no adverse effect observed, Cobalt chromite blue green spinel,68187-11-1, Sub-acute oral toxicity A 28 -day repeated dose toxicity study was conducted in rats as a limit test to assess the effect of the pigment cobalt zinc aluminate blue spinel on rats following repeated oral administration. The study was performed according to OECD test guideline 407 and in compliance with GLP. No signs of systemic toxicity whatsoever were observed in rats when administered at a dose of 1000 mg/kg bw/day for up to 28 days.The no observed adverse effect level (NOAEL) in rats is 1000 mg/kg/day. Sub-chronic inhalation toxicity A 90 -day repeated dose inhalation toxicity study is ongoing with the analogue pigment cobalt zinc aluminate blue spinel. The study will be performed according to OECD test guideline 413 and in compliance with GLP. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e91f8164-0ab4-4a8d-8559-725a6e289283/documents/dc1b6e33-24fb-4e4e-823f-5ec176155897_c294518c-5aa7-4cfc-abd2-eec8f480617e.html,,,,,, Cobalt chromite blue green spinel,68187-11-1, Acute inhalation toxicity: LC50 (rats; 4 hours) > 5.05 mg/L air (actual concentration) (OECD 436 (2009); GLP compliant) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e91f8164-0ab4-4a8d-8559-725a6e289283/documents/IUC5-952f6646-2b50-4ea4-9dfb-c9dcdd8f3819_c294518c-5aa7-4cfc-abd2-eec8f480617e.html,,,,,, Cobalt chromite green spinel,68187-49-5, Acute inhalation toxicity: LC50 > 5.05 mg/L (actual concentration)(OECD 436; GLP; male and female rats; 4 hr exposure) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e15edac8-b4ef-4f41-9056-2de6f16fef48/documents/58642b0f-4c0b-4eb6-abcc-2dfd693f8474_14b70f93-5f06-41fd-9b54-84e61725cc48.html,,,,,, Cobalt dihydroxide,21041-93-0, Acute oral toxicity: LD50 (rat) = 1060 mg cobalt dihydroxide/kg bw Acute dermal toxicity: Conduct of an acute dermal toxicity study for cobalt dihydroxide is unjustified since dermal uptake is considered negligible. Acute inhalation toxicity: LC50 (4 h): <0.05 mg/L air (analytical) (male/female) based on: test mat. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c6308df-6c5b-4e23-a1ea-93b9e234bc4a/documents/IUC5-a131332d-fecc-412e-9b38-d7e6feada3cf_fc8d34a3-23aa-40bd-96bd-bdd4c9f98952.html,,,,,, Cobalt dihydroxide,21041-93-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c6308df-6c5b-4e23-a1ea-93b9e234bc4a/documents/IUC5-a131332d-fecc-412e-9b38-d7e6feada3cf_fc8d34a3-23aa-40bd-96bd-bdd4c9f98952.html,,oral,LD50,"1,060 mg/kg bw",adverse effect observed, Cobalt dihydroxide,21041-93-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c6308df-6c5b-4e23-a1ea-93b9e234bc4a/documents/IUC5-a131332d-fecc-412e-9b38-d7e6feada3cf_fc8d34a3-23aa-40bd-96bd-bdd4c9f98952.html,,inhalation,LC50,0.05 mg/m3,adverse effect observed, Cobalt disodium ethylenediaminetetraacetate,15137-09-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b377e06-32d8-4c7e-a49d-e6cf70a5fce2/documents/f565d097-b5ee-4c26-97c6-099ef47f0165_ad0f9bcb-9767-413e-95a2-41d3bee5445c.html,,oral,LD50,729 mg/kg bw,adverse effect observed, Cobalt hydroxide oxide,12016-80-7,Acute oral toxicity:LD50(rat)> 5000 mg cobalt hydroxide oxide/kg bwAcute dermal toxicity:Conduct of an acute dermal toxicity study for cobalt hydroxide oxide is unjustified since dermal uptake is considered negligible.Acute inhalation toxicity:The classification from the acute oral toxicity is read-across to the acute toxicity via inhalation. Further results from the ongoing testing programme will be included upon availability. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3487a1fa-2f44-432b-accc-7ae8b5b3dec3/documents/IUC5-120cdb48-08f0-49a4-b75b-f42ee84a5d45_5206f216-c88e-48c4-bca3-a53b2059af21.html,,,,,, Cobalt lithium dioxide,12190-79-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): key study available Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): key study available ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5cc125ec-52be-487c-a20f-a28ed64472d1/documents/8726ea4d-be17-45b0-9ae4-ccff9d16330e_aebd057d-c862-4cda-9a98-a1ad9eb3b736.html,,,,,, Cobalt lithium dioxide,12190-79-3," Acute oral toxicity:LD50(female rats)> 5000 mg/kg bwAcute toxicity, dermal:Conduct of an acute dermal toxicity study is unjustified since dermal uptake is considered negligible (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006).Acute toxicity, inhalation: LC50(rat)> 5 mg/L ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cc125ec-52be-487c-a20f-a28ed64472d1/documents/IUC5-d5c44949-3a9d-481a-9a9b-cf516de8a710_aebd057d-c862-4cda-9a98-a1ad9eb3b736.html,,,,,, Cobalt molybdate,13762-14-6,Read-across dataLOAEC (rat): 0.114 mg Co2+/m³ LOAEC (mouse): 0.114 mg Co2+/m³ ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c9c9622-5120-446b-9f32-e900c5b978b5/documents/IUC5-0df4f1a8-81f1-458c-a693-64b7b764aa93_6f1a7e32-13b6-47fd-96d7-76ed3ea80c7c.html,,,,,, Cobalt molybdate,13762-14-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c9c9622-5120-446b-9f32-e900c5b978b5/documents/IUC5-0df4f1a8-81f1-458c-a693-64b7b764aa93_6f1a7e32-13b6-47fd-96d7-76ed3ea80c7c.html,Repeated dose toxicity – local effects,inhalation,LOAEC,0.114 mg/m3,adverse effect observed,other:rats and mice Cobalt molybdate,13762-14-6,"Oral (OECD 423), rat: LD50: 2500 mg/kg bw (cut-off value)Read-across from molybdenum substances: Inhalation (OECD 403), rat: LD50 > the maximum attainable test concentration or > 5 mg/L air (RA from soluble molybdenum substances; limit tests)Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw (RA from soluble molybdenum substances; limit tests) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c9c9622-5120-446b-9f32-e900c5b978b5/documents/IUC5-ecb94cc1-5669-48ae-8fc0-dd0224bf6128_6f1a7e32-13b6-47fd-96d7-76ed3ea80c7c.html,,,,,, Cobalt molybdate,13762-14-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c9c9622-5120-446b-9f32-e900c5b978b5/documents/IUC5-ecb94cc1-5669-48ae-8fc0-dd0224bf6128_6f1a7e32-13b6-47fd-96d7-76ed3ea80c7c.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, Cobalt oxalate,814-89-1, Acute oral toxicity: LD50(rat)> 5000 mg cobalt oxalate/kg bw Acute dermal toxicity: Conduct of an acute dermal toxicity study for cobalt oxalate is unjustified since dermal uptake is considered negligible. Acute inhalation toxicity: LC50(rat)> 5.06 mg cobalt oxalate/L ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10a56e93-88c9-484d-b1a8-e1cac4eb86b4/documents/IUC5-0ab4c8e5-3940-4cf4-ae6e-5ce5f8cbc83c_a65e9dcd-e1eb-49f6-bbf2-c0c32a5a8a0e.html,,,,,, Cobalt oxide,1307-96-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Key study available ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26163fe0-a747-4dca-aa2e-f546395f3ad8/documents/2e2ea99e-8b7c-446a-b112-59cb1995faa8_831c8999-0a29-4a67-8d37-131f17be4d8e.html,,,,,, Cobalt oxide,1307-96-6,"Acute oral toxicity:LD50 (rat)= 202 mg cobalt monoxide /kg bw (confidence interval: 136 - 300 mg/kg bw)Acute dermal toxicity:Conduct of an acute dermal toxicity study for cobalt oxide is unjustified since dermal uptake is considered negligible.Acute inhalation toxicity:LC50 (male and female rats, 4 hours): 0.06 mg/L air ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26163fe0-a747-4dca-aa2e-f546395f3ad8/documents/IUC5-fc146294-b1b6-4057-8fe9-fa11f535eaab_831c8999-0a29-4a67-8d37-131f17be4d8e.html,,,,,, Cobalt oxide,1307-96-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26163fe0-a747-4dca-aa2e-f546395f3ad8/documents/IUC5-fc146294-b1b6-4057-8fe9-fa11f535eaab_831c8999-0a29-4a67-8d37-131f17be4d8e.html,,oral,LD50,202 mg/kg bw,adverse effect observed, Cobalt oxide,1307-96-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26163fe0-a747-4dca-aa2e-f546395f3ad8/documents/IUC5-fc146294-b1b6-4057-8fe9-fa11f535eaab_831c8999-0a29-4a67-8d37-131f17be4d8e.html,,inhalation,LC50,60 mg/m3,adverse effect observed, Cobalt sulphide,1317-42-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): key study available ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ce87924-f444-4530-9326-dcc632f7c4b6/documents/6eb78115-cb03-40de-9df4-fd88e23d68c0_9e04c296-6c8e-4851-be00-9be9d2498dba.html,,,,,, Cobalt sulphide,1317-42-6,"Acute oral toxicity:LD50(rat)> 5000 mg cobalt sulphide/kg bw Acute inhalation toxicity:LC50 (4h, rat)> 5.09 mg cobalt sulphide/L air Acute dermal toxicity:Conduct of an acute dermal toxicity study for cobalt sulphide is unjustified since dermal uptake is considered negligible. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The study is reliable without restrictions. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ce87924-f444-4530-9326-dcc632f7c4b6/documents/IUC5-fe1e70c9-6002-4fa8-a790-929c19d9bcc5_9e04c296-6c8e-4851-be00-9be9d2498dba.html,,,,,, Cobalt sulphide,1317-42-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ce87924-f444-4530-9326-dcc632f7c4b6/documents/IUC5-fe1e70c9-6002-4fa8-a790-929c19d9bcc5_9e04c296-6c8e-4851-be00-9be9d2498dba.html,,inhalation,LC50,> 5.09 mg/L,no adverse effect observed, Cobalt titanite green spinel,68186-85-6,"Oral90d rat: NOAEL >= 450 mg/kg bw/day; no bioavailability (OECD 408, Bomhard et al. 1982)46d (males)/ 41-45d (females) rat: NOAEL >= 1000 mg/kg bw/day (OECD 422, MHLW 2002)Inhalation5 d rat: NOAEL >= 0.06 mg/L; clearance in the lung, no bioavailability (BASF 1994)Because of the nickel titanate impurity in C.I. Pigment Green 50, surrogate data from other nickel species for the inhalation route are used to fully assess the endpoint. Inhalation exposure related toxicities were noted following 13 weeks or two years of exposure to NiO (Dunnick et al. 1989, NTP, 1996) in both rats and mice. Adverse effects in rodents were primarily limited to the lung (e. g., increased tissue weight, inflammation, macrophage hyperplasia) The LOAEC from the corresponding chronic study was 0.6 mg NiO/m3 or 0.5 mg Ni/m3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7f9f114-00a3-4ee1-828e-0c451a28f374/documents/IUC5-2e876193-24b2-4bbd-87d5-15a662a85552_38b8e140-11c6-4ed8-96d6-c1920bd782a0.html,,,,,, Cobalt titanite green spinel,68186-85-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7f9f114-00a3-4ee1-828e-0c451a28f374/documents/IUC5-2e876193-24b2-4bbd-87d5-15a662a85552_38b8e140-11c6-4ed8-96d6-c1920bd782a0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Cobalt titanite green spinel,68186-85-6,"In two acute oral toxicity studies, LD50 values of greater than 2000 mg/kg bw/d and above 10000 mg/kg bw/d were determined for male and female Sprague Dawley rats. No mortality was observed in any of the two tests. (MHLW, 2002; BASF, 1978) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7f9f114-00a3-4ee1-828e-0c451a28f374/documents/IUC5-fec0a742-10c4-4a74-89e1-c1cef2b1ab73_38b8e140-11c6-4ed8-96d6-c1920bd782a0.html,,,,,, Cobalt titanite green spinel,68186-85-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7f9f114-00a3-4ee1-828e-0c451a28f374/documents/IUC5-fec0a742-10c4-4a74-89e1-c1cef2b1ab73_38b8e140-11c6-4ed8-96d6-c1920bd782a0.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Cobalt trihydroxide,1307-86-4,"Acute oral toxicity:LD50(rat)> 5000 mg/kg bwAcute toxicity, dermal:Conduct of an acute dermal toxicity study is unjustified since dermal uptake is considered negligible (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ae20b27-b8b2-48c7-a4a1-4a644a43ed68/documents/IUC5-f9831dec-1f4d-48f7-8739-8f4e5fc0a058_d39c6fbf-4d46-44c7-87e4-6b004e389a7e.html,,,,,, Cobalt zinc aluminate blue spinel,68186-87-8,"It is concluded that the pigment was well tolerated and that no signs of systemic toxicity whatsoever were observed had been seen in rats when administered at a dose of 1000 mg/kg bw/day for up to 28 days. Either no or only marginal increases in Al, Zn and Co plasma concentrations were observed, and only a minor fraction (<0.003%) of the total administered dose of Co, Al and Zn was collected via urine, documenting the lack of bioavailability of this pigment. The no observed adverse effect level (NOAEL) in rats is 1000 mg/kg/day.   In a 90 -day repeated dose toxicity by inhalation study, rats were exposed via nose-only inhalation towards aerosol concentrations of 0.4, 1.5 and 6 mg/m³ of cobalt zinc aluminate blue spinel. All animals survived the test period and were euthanized at scheduled dates. Effects indicating systemic toxicity were not observed. Sex-specific differences were not detected.The NOAEC was considered to be 6 mg/m³ (the concentration at or above the onset of lung overload, thus constituting the maximum tolerated concentration). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/02c5772f-e2f6-4f88-9960-fdf4237915af/documents/IUC5-420b9711-7f03-463a-be09-470911ef889c_4ae9197c-6fc5-4d21-b1e0-6ec3d275d282.html,,,,,, Cobalt zinc aluminate blue spinel,68186-87-8,"Acute oral toxicity: LD50 > 5000 mg/kg bw (OECD 423; GLP-compliant; female rats) Acute toxicity, inhalation: LC50 >5.06 mg/L air. Particle size parameter: d(0.1) = 0.30 µm; d(0.5) = 2.23 µm (median); d(0.9) = 4.74 µm Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study fulfils the rquirements for acute oral toxicity under REACH (Regulation (EC) 1907/2006). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02c5772f-e2f6-4f88-9960-fdf4237915af/documents/IUC5-21115b19-75e0-4189-8dae-e187efb929b3_4ae9197c-6fc5-4d21-b1e0-6ec3d275d282.html,,,,,, Cobalt zinc silicate blue phenacite,68412-74-8, Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 401; GLP compliant) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01dfff5a-d6e7-4885-9369-233a3c89e660/documents/IUC5-defd238e-1d69-42b7-911f-cf38c5a830a2_6902a3f3-469e-4578-8b13-6efcae00bedd.html,,,,,, Cobalt(2+) disulphamate,14017-41-5," Read-across from soluble cobalt substances (i.e., cobalt dichloride and cobalt sulfate) and sodium sulfamate to cobalt(2 +) disulfamate is performed. A detailed documentation on read-across is attached on IUCLID section 13 (CoSulf_Read Across Assessment Framework Report). Sodium sulfamate: The LD50 of the substance in the female Wistar strain rat was estimated to be greater than 2500 mg/kg bodyweight (OECD 423). Soluble cobalt substances: The references Speijers (1982) and Llobet, Domingo (1983) are considered as the key studies for acute oral toxicity and will be used for classification. Female/male rats were dosed at 500, 600, 720, 864, 1137 mg/kg bw orally via gavage and at 350, 392, 450, 518, 595, 684, 787mg/kg orally via gavage respectively. During the conduct of the study mortalities occurred, thus the following LD50 values were derived: Speijers (1982): LD50 (combined male and female rats): 766 mg/kg bw (95 % confidence interval: 677 - 867 mg/kg bw)  Llobet, Domingo (1983): LD50: 537 mg/kg (Confidence interval: 479 – 601 mg/kg bw) Using the lowest LD50 value for cobalt dichloride hexahydrate (537 mg/kg bw) and the value for sodium sulfamate (2500 mg/kg bw), considering a cobalt content of 23.47% and a sulfamate content of 76.53% in cobalt(2 +) disulfamate, the calculated LD50 value for cobalt(2 +) disulfamate using the ATE formula given in ECHA guidance document R.7a resulted in an LD50 of 387.4 mg cobalt(2 +) disulfamate/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7fc10bed-ebf7-4aa3-9a3b-263b1e48b868/documents/83d4417b-6744-454e-aafc-6d500b41ce60_4213305c-5213-4e42-b54a-c75843ce3759.html,,,,,, Cobalt(2+) disulphamate,14017-41-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7fc10bed-ebf7-4aa3-9a3b-263b1e48b868/documents/83d4417b-6744-454e-aafc-6d500b41ce60_4213305c-5213-4e42-b54a-c75843ce3759.html,,oral,LD50,387.4 mg/kg bw,adverse effect observed, Cobalt(2+) hydrogen citrate,18727-04-3,"Read-across with cobalt sulfate heptahydrateNo NOAECs were identified, neither for rats nor for mice.LOAEC (local, rat): 0.5 mg/m³ cobalt hydrogen citrate (recalculated value)LOAEC (local, mouse): 0.5 mg/m³ cobalt hydrogen citrate (recalculated value) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de0365ad-5497-46b7-af59-b9c055321ada/documents/IUC5-bb19cd60-737e-441d-bcfb-e9f1aceb385f_88807386-b731-436a-9d7a-c45df9bb8946.html,,,,,, Cobalt(2+) hydrogen citrate,18727-04-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de0365ad-5497-46b7-af59-b9c055321ada/documents/IUC5-bb19cd60-737e-441d-bcfb-e9f1aceb385f_88807386-b731-436a-9d7a-c45df9bb8946.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,4.8 mg/m3,,mouse Cobalt(2+) hydrogen citrate,18727-04-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de0365ad-5497-46b7-af59-b9c055321ada/documents/IUC5-bb19cd60-737e-441d-bcfb-e9f1aceb385f_88807386-b731-436a-9d7a-c45df9bb8946.html,Repeated dose toxicity – local effects,inhalation,LOAEC,0.5 mg/m3,adverse effect observed,rat Cobalt(2+) hydrogen citrate,18727-04-3,Cobalt citrateOral: LD50 (rat) = 500 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de0365ad-5497-46b7-af59-b9c055321ada/documents/IUC5-633eb114-768b-44ba-8342-86e3030286be_88807386-b731-436a-9d7a-c45df9bb8946.html,,,,,, Cobalt(2+) hydrogen citrate,18727-04-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de0365ad-5497-46b7-af59-b9c055321ada/documents/IUC5-633eb114-768b-44ba-8342-86e3030286be_88807386-b731-436a-9d7a-c45df9bb8946.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Cobalt(2+) propionate,1560-69-6," Acute oral toxicity: LD50 (female rats): 355 mg cobalt propionate/kg (Confidence interval: 61.2 - 1890 mg/kg)   Acute inhalation toxicity: LC50 (4h, rat, both sexes) is between 1.03 and 5.09 mg cobalt propionate/L air. The test material is classified as acute toxic via the inhalative route (Category 4; H332).   Acute dermal toxicity: Conduct of an acute dermal toxicity study for cobalt propionate is unjustified since dermal uptake is considered negligible. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1dd6c81-4170-4cf5-9854-4e34c693bf91/documents/IUC5-a660afc3-a113-4cc1-9701-f0190f73e53e_a4e0b7b9-d0bf-451e-8ca8-d1d3a9ecbe91.html,,,,,, Cobalt(2+) propionate,1560-69-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1dd6c81-4170-4cf5-9854-4e34c693bf91/documents/IUC5-a660afc3-a113-4cc1-9701-f0190f73e53e_a4e0b7b9-d0bf-451e-8ca8-d1d3a9ecbe91.html,,oral,LD50,355 mg/kg bw,adverse effect observed, Cobalt(2+) propionate,1560-69-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1dd6c81-4170-4cf5-9854-4e34c693bf91/documents/IUC5-a660afc3-a113-4cc1-9701-f0190f73e53e_a4e0b7b9-d0bf-451e-8ca8-d1d3a9ecbe91.html,,inhalation,LC50,>=1.03 mg/L,adverse effect observed, Cobalt(II) 4-oxopent-2-en-2-olate,14024-48-7,Acute oral toxicity:LD50(female rats): >300 mg/kg bw and <=2000 mg/kg bwAcute inhalation toxicity:LC50 (male and female rats): > 5.09 mg/L air (analytical)Acute dermal toxicity:LD50(male and female rats): >2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bb95789-cbd8-4aa2-9556-214c76cc0ea0/documents/IUC5-a0b9092c-f725-4c37-b3e7-10cffb28c101_307b903c-b354-4830-b80c-5d54e9a894b6.html,,,,,, "Cobalt, borate 2-ethylhexanoate complexes",91782-60-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): key study available ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/465fb4c7-812b-4414-83d3-9bc555d7defa/documents/342bd78e-2da5-47fd-ba3b-79c80e47db95_a6c7f553-5ffb-4093-b282-2c72ce6bbf73.html,,,,,, "Cobalt, borate 2-ethylhexanoate complexes",91782-60-4,"Acute oral toxicity:LD50=2210 mg/kgAcute toxicity, dermal:Conduct of an acute dermal toxicity study is unjustified since dermal uptake is considered negligible (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006).Acute toxicity, inhalation:The classification from the acute oral toxicity is read-across to the acute toxicity via inhalation. Further results from the ongoing testing programme will be included upon availability. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/465fb4c7-812b-4414-83d3-9bc555d7defa/documents/IUC5-b7187838-de66-4a18-95e8-34b72df5863b_a6c7f553-5ffb-4093-b282-2c72ce6bbf73.html,,,,,, "Cobalt, borate 2-ethylhexanoate complexes",91782-60-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/465fb4c7-812b-4414-83d3-9bc555d7defa/documents/IUC5-b7187838-de66-4a18-95e8-34b72df5863b_a6c7f553-5ffb-4093-b282-2c72ce6bbf73.html,,oral,LD50,"2,210 mg/kg bw",no adverse effect observed, "Cobalt, borate neodecanoate complexes",68457-13-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40e915ae-6fb8-46ca-a791-fb1a836b0dde/documents/IUC5-092da4b8-7b06-4830-9722-67cf6d95abbd_da6292ae-fea5-4f12-a00b-2a1dd4ef3405.html,,oral,LD50,"1,098 mg/kg bw",adverse effect observed, "Cobalt, borate propionate complexes",91782-61-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): key study available ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/753ca05b-2888-46d3-8d41-0779f9edabe7/documents/342bd78e-2da5-47fd-ba3b-79c80e47db95_cd134918-8547-4fbd-8843-11a304437a4b.html,,,,,, "Cobalt, borate propionate complexes",91782-61-5,"Acute oral toxicity:LD50=310 mg/kgAcute toxicity, dermal:Conduct of an acute dermal toxicity study is unjustified since dermal uptake is considered negligible (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006).Acute toxicity, inhalation:The classification from the acute oral toxicity is read-across to the acute toxicity via inhalation. Further results from the ongoing testing programme will be included upon availability. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/753ca05b-2888-46d3-8d41-0779f9edabe7/documents/IUC5-9a43c6d5-f730-4fee-93b4-bc8d8a5bd0b5_cd134918-8547-4fbd-8843-11a304437a4b.html,,,,,, "Cobalt, borate propionate complexes",91782-61-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/753ca05b-2888-46d3-8d41-0779f9edabe7/documents/IUC5-9a43c6d5-f730-4fee-93b4-bc8d8a5bd0b5_cd134918-8547-4fbd-8843-11a304437a4b.html,,oral,LD50,310 mg/kg bw,adverse effect observed, "Cobaltate(1-), bis[2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)]-, hydrogen, compd. with [1R-(1α,4aβ,10aα)]-1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-1-phenanthrenemethanamine (1:1)",20506-24-5,"In an acute oral toxicity study in rats an oral LD50 of 5000 mg/kg bw was determined. (BASF, 1973) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d887d47a-2113-454d-aecf-45a7992cab7a/documents/IUC5-d899b728-8e32-4d14-bad2-b77472eee161_4d103497-5965-45c6-b747-e1d8ce78d087.html,,,,,, "Cobaltate(1-), bis[2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-(methylsulfonyl)phenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)]-, hydrogen, compd. with [1R-(1α,4aβ,10aα)]-1,2,3,4,4a,9,10,10a-octahydro-1,4a-dimethyl-7-(1-methylethyl)-1-phenanthrenemethanamine (1:1)",20506-24-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d887d47a-2113-454d-aecf-45a7992cab7a/documents/IUC5-d899b728-8e32-4d14-bad2-b77472eee161_4d103497-5965-45c6-b747-e1d8ce78d087.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Cobaltate(3-), bis[4-[4-[[4-[4-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)]-, trisodium",75214-72-1, LD50 (oral) > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0191967b-8be3-4bb0-9bff-c97cd74f4f30/documents/aefa481e-5d2b-4745-9802-d67779c575e8_503499a4-77af-4607-a3e6-ede042c3b74a.html,,,,,, "Cobaltate(3-), bis[6-amino-5-[(2-hydroxy-3,5-dinitrophenyl)azo]-1-naphthalenesulfonato(3-)]-, sodium",85049-76-9, LD50 in rats > 2000 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e09b904e-f468-4468-b8d8-e71ff2c47db1/documents/46d6ca9c-174f-41b6-9f67-a3b33e25104d_c29e48f0-bd08-4005-b1e3-6acc2359b439.html,,,,,, "Cobaltate(3-), bis[6-amino-5-[(2-hydroxy-3,5-dinitrophenyl)azo]-1-naphthalenesulfonato(3-)]-, sodium",85049-76-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e09b904e-f468-4468-b8d8-e71ff2c47db1/documents/46d6ca9c-174f-41b6-9f67-a3b33e25104d_c29e48f0-bd08-4005-b1e3-6acc2359b439.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Cocoa, powd., alkalized",95009-22-6,"In the studies documented in CSR, the dietary level(s) of cocoa tested represent amounts far exceeding cocoa consumption by humans. A recent approximation of cocoa powder consumption in 2011 (using cocoa production data from 2011 and EU27 population statistics) approximates European cocoa powder consumption to be 18.5 mg/kg bw day. The above information, as well as the knowledge that a vast majority of the population (including children) regularly consume large quantities of cocoa containing products, clearly indicates that there is no concern regarding the repeated oral toxicity of cocoa.In accordance with the results obtained from the key and supporting studies, cocoa powder is not classified according to CLP i.e. NOEL (or derived/adjusted LOEL) dose/concentration exceeds the guidance value ranges of 10 < C ≤ 100 mg/kg/bw/day, (Regulation (EC) No 1272/2008). [ Please refer CSR 5.6.3] ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c903d3a2-bf72-4e77-ada6-15104d48c6d4/documents/IUC5-a63c8158-f80f-4864-a4d1-990e9871bd6a_da5f7659-1d6e-48b4-b28d-cebef922738d.html,,,,,, "Cocoa, powd., alkalized",95009-22-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c903d3a2-bf72-4e77-ada6-15104d48c6d4/documents/IUC5-a63c8158-f80f-4864-a4d1-990e9871bd6a_da5f7659-1d6e-48b4-b28d-cebef922738d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,000 mg/kg bw/day",,rabbit "Coconut oil, reaction products with boric acid (H3BO3), diethanolamine and glycerol",1428353-74-5,"The assessment is based on a weight of evidence using test material, CAS RN 63310-16-7, which was determined to have a NOAEL of 1000 mg/kg/day in a 28 day repeat dose study performed in accordance with OECD 410. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9441b99f-f968-436c-945d-371f018476e4/documents/IUC5-beba63e7-a27a-4718-bb13-40889a83265c_65d45fe4-be87-4679-aca4-c38a6d412392.html,,,,,, "Coconut oil, reaction products with boric acid (H3BO3), diethanolamine and glycerol",1428353-74-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9441b99f-f968-436c-945d-371f018476e4/documents/IUC5-beba63e7-a27a-4718-bb13-40889a83265c_65d45fe4-be87-4679-aca4-c38a6d412392.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Coconut oil, reaction products with boric acid (H3BO3), diethanolamine and glycerol",1428353-74-5,"ORAL: LD50 = > 2000 mg/kg male/female rat, OECD 423, Weinberg JT (2015)DERMAL: LD50 = > 2000 mg/kg male/female rat, OECD 402, Weinberg JT (2015) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9441b99f-f968-436c-945d-371f018476e4/documents/IUC5-1ed25700-5696-4d20-8836-d35e9e9116aa_65d45fe4-be87-4679-aca4-c38a6d412392.html,,,,,, "coconut oil, reaction products with glycerol esters of 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoic acid",179986-09-5,"90-days-study, oral (OECD Guideline Study 408, Notox 487736, 2008): NOAEL (male/female) = 14 mg/kg bw 28-days-study, oral (OECD Guideline Study 407, RCC 636456, 1997): NOAEL (male/female) = 50 mg/kg bw ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ade928d-fec2-4c8f-bd51-9ca19ee6c20f/documents/IUC5-fb8cbe64-292d-4ede-bc6a-ee2709a600e3_349dc88e-9b99-48be-a8ad-ef252396c1cd.html,,,,,, "coconut oil, reaction products with glycerol esters of 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoic acid",179986-09-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ade928d-fec2-4c8f-bd51-9ca19ee6c20f/documents/IUC5-fb8cbe64-292d-4ede-bc6a-ee2709a600e3_349dc88e-9b99-48be-a8ad-ef252396c1cd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,14 mg/kg bw/day,,rat "coconut oil, reaction products with glycerol esters of 3,5-bis(1,1-dimethylethyl)-4-hydroxybenzenepropanoic acid",179986-09-5,"Oral: LD50 >2000 mg/kg bw (EU Method B.1, OECD Guideline 401)Inhalation: no dataDermal: LD50 >2000 mg/kg bw (EU Method B.3, OECD Guideline 402) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ade928d-fec2-4c8f-bd51-9ca19ee6c20f/documents/IUC5-896266b5-2874-445d-90d8-0c2ddd685458_349dc88e-9b99-48be-a8ad-ef252396c1cd.html,,,,,, "Reaction products of coconut oil with polyethyleneglycol and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol",218451-68-4,"In conclusion, there was no evidence of toxicity after oral gavage administration of 1000 mg/kg/day of Coconut Oil, Reaction Products with Polyethylene Glycol and Trimethylolpropane for at least 90 consecutive days to Han Wistar rats. Based on these results, the no-observed-effect level (NOEL) was considered to be at least 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1452c4c5-191a-4746-b521-8da3ac39379e/documents/IUC5-d9b85bb5-5870-43d4-8ef3-cb6909ae20e4_20777f60-bd83-4de3-82b0-dc3a5af93b67.html,,,,,, "Reaction products of coconut oil with polyethyleneglycol and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol",218451-68-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1452c4c5-191a-4746-b521-8da3ac39379e/documents/IUC5-d9b85bb5-5870-43d4-8ef3-cb6909ae20e4_20777f60-bd83-4de3-82b0-dc3a5af93b67.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Reaction products of coconut oil with polyethyleneglycol and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol",218451-68-4,"The oral and dermal LD50 of Coconut oil, reaction products with polyethylene glycol and trimethylolpropane was found to be > 2000 mg/kg bodyweight. Therefore the substance is practically nontoxic. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1452c4c5-191a-4746-b521-8da3ac39379e/documents/IUC5-0f13f93c-7146-4a50-8cf4-cf3724b6c4db_20777f60-bd83-4de3-82b0-dc3a5af93b67.html,,,,,, "Reaction products of coconut oil with polyethyleneglycol and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol",218451-68-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1452c4c5-191a-4746-b521-8da3ac39379e/documents/IUC5-0f13f93c-7146-4a50-8cf4-cf3724b6c4db_20777f60-bd83-4de3-82b0-dc3a5af93b67.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction products of coconut oil with polyethyleneglycol and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol",218451-68-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1452c4c5-191a-4746-b521-8da3ac39379e/documents/IUC5-0f13f93c-7146-4a50-8cf4-cf3724b6c4db_20777f60-bd83-4de3-82b0-dc3a5af93b67.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Coke (coal), naphtha cracking ethylene manuf. by-product",94581-02-9,LD50 (oral): > 10000 mg/kg bw ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e27abe5b-9d0a-47a7-9591-e6091e9c68b7/documents/IUC5-4d5e9572-fa23-4eb4-b525-5c38461aba95_ee60113b-fbe0-4093-8d24-3b2be8d351c2.html,,,,,, "Coke (coal), naphtha cracking ethylene manuf. by-product",94581-02-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e27abe5b-9d0a-47a7-9591-e6091e9c68b7/documents/IUC5-4d5e9572-fa23-4eb4-b525-5c38461aba95_ee60113b-fbe0-4093-8d24-3b2be8d351c2.html,,oral,LD50,"10,000 mg/kg bw",, "Condensates (petroleum), vacuum tower",64741-49-7," There are seven oral sub-acute repeated dose oral studies conducted according to OECD TG 422. In sub-acute oral studies on CAS Numbers 64741-77-1, 68476-34-6, 68476-30-2 and 68334 -30 -5, there were no treatment-related adverse effects on systemic toxicity parameters up to and including the highest doses tested (1000 mg/kg/day for 68334 -30 -5 and 750 mg/kg/day for the remaining CAS numbers) and accordingly the NOAELs were set at these levels. In a sub-acute oral study on CAS 68476 -31 -3 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 750 mg/kg/day for males and 100 mg/kg/day for females.   In a sub-acute oral study on CAS 64741 -49 -7 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 750 mg/kg/day for males and 300 mg/kg/day for females. In a sub-acute oral study on CAS 68476 -31 -3 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 300 mg/kg/day for males and females. Supporting information is available, with two studies conducted on petroleum substances in other categories; a sub-chronic study on a Kerosine (CAS 8008-20-6) and a chronic study on a Highly Refined Base Oil (CAS 8042-47-5). These do not contain significant amounts of the PAH constituents considered to be the drivers of toxicological hazard for VHGO, but have other constituents in common. They help to demonstrate that no significant toxicological hazard is expected from other aliphatic (paraffinic and naphthenic) and aromatic (mono- and di- aromatic) constituents.   In addition, one oral sub-chronic study is proposed on a VHGO substance containing high levels of PAH constituents.   For sub-chronic inhalation toxicity of VGOs/HGOs/Distillate fuels, a conservative sub-chronic NOAEC of 750 mg/m3 was determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of >1710 mg/m3 was established for systemic effects, based on no significant findings at this level (OECD 413).   In a subacute dermal repeated-dose toxicity test, the NOEL level based on dermal irritation was 0.0001 mL/kg and a NOEL of 0.5 mL/kg was calculated for systemic toxicity (OECD 410). For subchronic dermal toxicity, a NOAEL of 30 mg/kg body weight/day appears appropriate for VGOs/HGOs/Distillate fuels based on changes in haematological parameters (decreased RBC, haemoglobin, HCT), clinical chemistry values (increased urea nitrogen and cholesterol) parameters and organ weight effects (increased liver weight, decreased thymus weight). The NOAEL for local effects is 125 mg/kg body weight/d, based on histopathological changes present at the application site (OECD 411). In addition, a recent study to OECD 411 and GLP was conducted on a member of the VHGO category. This showed low systemic toxicity (NOAEL 600 mg/kg/day), with higher doses not possible due to excessive local irritation. This study was conducted on a substance in the category low in PAH content (the constituent expected to drive toxicological hazard). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dca69738-c861-42ab-8066-41642963e6fc/documents/246ae508-16eb-446c-afd1-ad680080afdb_d5525734-f6ae-4870-8b89-50aee7c5f51a.html,,,,,, "Condensates (petroleum), vacuum tower",64741-49-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dca69738-c861-42ab-8066-41642963e6fc/documents/246ae508-16eb-446c-afd1-ad680080afdb_d5525734-f6ae-4870-8b89-50aee7c5f51a.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,30 mg/kg bw/day,,rat "Condensates (petroleum), vacuum tower",64741-49-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dca69738-c861-42ab-8066-41642963e6fc/documents/246ae508-16eb-446c-afd1-ad680080afdb_d5525734-f6ae-4870-8b89-50aee7c5f51a.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Condensates (petroleum), vacuum tower",64741-49-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dca69738-c861-42ab-8066-41642963e6fc/documents/246ae508-16eb-446c-afd1-ad680080afdb_d5525734-f6ae-4870-8b89-50aee7c5f51a.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Condensates (petroleum), vacuum tower",64741-49-7," Acute Oral Toxicity: Acute oral toxicity of #2 home heating oil, was evaluated in male and female rats following a single oral gavage administration of the test material at different concentrations (similar to OECD 401).  The  LD50 for #2 home heating oil is 21.1 mL/kg body weight (approx 17,900 mg/kg). Based on all acute oral toxicity studies, the LD50 for VGOs/HGOs/Distillate fuels is > 5000 mg/kg bw. Acute Inhalation Toxicity: Acute inhalation toxicity of naval distillate in male and female rats was evaluated in a study involving whole-body exposure  for 4 hours (similar to OECD 403).  The acute inhalation LC50 was 4.1 mg/L . Acute Dermal Toxicity: In an acute dermal toxicity study, male and female New Zealand White rabbits were exposed to #2 home heating oil for 24 hours at a dose level of 5 mL/kg (approx 4300 mg/kg). The animals were then observed for 14 days (similar to OECD 402).  Based on this study, the acute dermal LD50 is > 4300 mg/kg.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dca69738-c861-42ab-8066-41642963e6fc/documents/50ca8717-e805-460b-bb99-b647882e2c88_d5525734-f6ae-4870-8b89-50aee7c5f51a.html,,,,,, "Condensates (petroleum), vacuum tower",64741-49-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dca69738-c861-42ab-8066-41642963e6fc/documents/50ca8717-e805-460b-bb99-b647882e2c88_d5525734-f6ae-4870-8b89-50aee7c5f51a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Condensates (petroleum), vacuum tower",64741-49-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dca69738-c861-42ab-8066-41642963e6fc/documents/50ca8717-e805-460b-bb99-b647882e2c88_d5525734-f6ae-4870-8b89-50aee7c5f51a.html,,dermal,LD50,"4,300 mg/kg bw",no adverse effect observed, "Condensates (petroleum), vacuum tower",64741-49-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dca69738-c861-42ab-8066-41642963e6fc/documents/50ca8717-e805-460b-bb99-b647882e2c88_d5525734-f6ae-4870-8b89-50aee7c5f51a.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, Constitutional isomers of penta-O-allyl-β-D-fructofuranosylα-D-glucopyranoside; Constitutional isomers of hexa-O-allyl-β-D-fructofuranosylα-D-glucopyranoside; Constitutional isomers of hepta-O-allyl-β-D-fructofuransoylα-D-glucopyranoside,68784-14-5,In a 28-day repeat oral dose study in the rat the NOAEL for systemic toxicity was 400 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b25a6ea0-4fbc-4baf-a0e7-6cd2a7f60050/documents/IUC5-17ba41a0-4a7c-4974-b988-e5d61575ed81_505e6a6a-347b-4b2b-b602-a4f8d90c2cfb.html,,,,,, Constitutional isomers of penta-O-allyl-β-D-fructofuranosylα-D-glucopyranoside; Constitutional isomers of hexa-O-allyl-β-D-fructofuranosylα-D-glucopyranoside; Constitutional isomers of hepta-O-allyl-β-D-fructofuransoylα-D-glucopyranoside,68784-14-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b25a6ea0-4fbc-4baf-a0e7-6cd2a7f60050/documents/IUC5-17ba41a0-4a7c-4974-b988-e5d61575ed81_505e6a6a-347b-4b2b-b602-a4f8d90c2cfb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat Constitutional isomers of penta-O-allyl-β-D-fructofuranosylα-D-glucopyranoside; Constitutional isomers of hexa-O-allyl-β-D-fructofuranosylα-D-glucopyranoside; Constitutional isomers of hepta-O-allyl-β-D-fructofuransoylα-D-glucopyranoside,68784-14-5,The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight.The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b25a6ea0-4fbc-4baf-a0e7-6cd2a7f60050/documents/IUC5-f7204eff-b70d-4d10-bf7f-b8ce47740314_505e6a6a-347b-4b2b-b602-a4f8d90c2cfb.html,,,,,, Constitutional isomers of penta-O-allyl-β-D-fructofuranosylα-D-glucopyranoside; Constitutional isomers of hexa-O-allyl-β-D-fructofuranosylα-D-glucopyranoside; Constitutional isomers of hepta-O-allyl-β-D-fructofuransoylα-D-glucopyranoside,68784-14-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b25a6ea0-4fbc-4baf-a0e7-6cd2a7f60050/documents/IUC5-f7204eff-b70d-4d10-bf7f-b8ce47740314_505e6a6a-347b-4b2b-b602-a4f8d90c2cfb.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Copper chloride,7758-89-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b84715c7-9d33-414b-a5ef-68590c6513de/documents/024f715d-4719-422e-82c1-f45beee4144b_19bce8e6-e1a3-4c27-bfe7-721775a1a9c6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat Copper chlorophthalocyanine,12239-87-1," Copper phthalocyanine pigments are inert high molecular weight blue to green colorants that did not cause treatment-related effects in GLP-compliant subacute gavage OECD 407 (Pigment Blue 16, Pigment Green 7, CAS 14832 -14 -5, CAS 68987-63-3) or subchronic feed application studies (Pigment Green 7 and Pigment Blue 16). The latter two studies were performed by the US National Toxicology programm to serve as a dose-range finder for a chronic study. However, since the subchronic feed application did not result in an increase in liver and kidney copper concentrations, the substances were concluded to be not taken up after ingestion and chronic testing was not performed. The substance is assessed to be non hazardous from experimental data on related copper phthalocyanine pigments. Details can be found in the read-across justification. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/addb1c70-476f-402a-87b1-fca3ceb48004/documents/990ea129-6db2-4d98-84a8-f60488edee50_65520396-8bb5-4ad9-8a89-0b1576516d45.html,,,,,, Copper chlorophthalocyanine,12239-87-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/addb1c70-476f-402a-87b1-fca3ceb48004/documents/990ea129-6db2-4d98-84a8-f60488edee50_65520396-8bb5-4ad9-8a89-0b1576516d45.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Copper chlorophthalocyanine,12239-87-1, The substance is considered to be non hazardous to rats by assessment of experimental on other chlorinated copper phthalocyanines. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/addb1c70-476f-402a-87b1-fca3ceb48004/documents/fbf10ee4-0af2-442c-b203-5f79e29067be_65520396-8bb5-4ad9-8a89-0b1576516d45.html,,,,,, Copper chlorophthalocyanine,12239-87-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/addb1c70-476f-402a-87b1-fca3ceb48004/documents/fbf10ee4-0af2-442c-b203-5f79e29067be_65520396-8bb5-4ad9-8a89-0b1576516d45.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Copper chromite black spinel,68186-91-4,"In conclusion, since the dissolved Cr and Cu concentrations from this pigment (copper chromite black spinel) under simulated physiological conditions were below 74 µg/L and 366 µg/L respectively, even at the highest loading of 0.1g/L, referring to a solubility of 0.074 % and 0.37 %, the pigment is considered biologically inert. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4acbe41f-757b-4985-8264-0c5dfaa06a06/documents/IUC5-38c3cdac-0a63-454b-9740-b5e94965ec76_d370bedc-c3fe-47c7-b552-9f4a294dbd19.html,,,,,, Copper chromite black spinel,68186-91-4,Acute oral toxicity: LD50 > 5000 mg/kg bw (equivalent or similar to OECD 401 (1987); Non-GLP compliant)Acute inhalation toxicity: LC50 (rats; 4 hours) > 5.07 mg/L air (actual concentration) (OECD 436 (2009); GLP compliant) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4acbe41f-757b-4985-8264-0c5dfaa06a06/documents/IUC5-bf837188-6c7d-4506-800f-ef639b5ee7b9_d370bedc-c3fe-47c7-b552-9f4a294dbd19.html,,,,,, Copper dichromium tetraoxide,12018-10-9,"A guideline-compliant and GLP-compliant acute study is available for the material 'Chromoxyd Dyko' (containig 96% chromium oxide), which shows low acute oral toxicity; similar findings are seen in two additional proprietary studies performed with chromium oxide and chromium hydroxide. No information is available on acute dermal toxicity. The results of a modern, proprietary GLP and guideline-compliant study (Gaunt, 2009) reports an LC50 value of >5.41 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1ab3c31-aed7-4bee-a1af-1b4113b725d5/documents/35c022b9-86b1-4b55-aab2-3aac686fb4ac_445e6d7f-f3b3-458b-ba89-3e0d5f18323f.html,,,,,, Copper dichromium tetraoxide,12018-10-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1ab3c31-aed7-4bee-a1af-1b4113b725d5/documents/35c022b9-86b1-4b55-aab2-3aac686fb4ac_445e6d7f-f3b3-458b-ba89-3e0d5f18323f.html,,oral,LD50,"5,000 mg/kg bw",, Copper dichromium tetraoxide,12018-10-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1ab3c31-aed7-4bee-a1af-1b4113b725d5/documents/35c022b9-86b1-4b55-aab2-3aac686fb4ac_445e6d7f-f3b3-458b-ba89-3e0d5f18323f.html,,inhalation,LC50,"5,410 mg/m3",, Copper dihydroxide,20427-59-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ed00aa0-9e7c-4fae-a574-5bda1e84ef06/documents/38549d2c-e466-49ad-8249-533f5db5508b_17b7e670-7c10-4a1c-8dcd-2ba74a8afdcb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat Copper dinitrate,3251-23-8,"The pivotal repeat dose study was a 90-day study by the oral route with copper sulphate pentahydrate. In rats and mice, ingestion of copper sulphate pentahydrate produced forestomach lesions that could be to the irritant effects of the compound. The NOAEL for this effect was 16.7 mg Cu/kg bw/day in rats and 97 and 126 mg Cu/kg bw/day in male and female mice respectively. In rats inflammation of the liver was observed. The NOAEL’s for liver and kidney damage were 16.7 mg Cu/kg bw/day in rats. This is the pivotal study and the NOAEL of 16.7 mg Cu/kg bw/day will be used in the risk characterisation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/46cb9aa1-3ba8-45e6-aa0c-4fdb75c53560/documents/76f8d235-2e69-429a-9d06-3d82ec62d57f_38e4afb6-2ba0-4f25-8c7a-a5d93facbb6f.html,,,,,, Copper dinitrate,3251-23-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/46cb9aa1-3ba8-45e6-aa0c-4fdb75c53560/documents/76f8d235-2e69-429a-9d06-3d82ec62d57f_38e4afb6-2ba0-4f25-8c7a-a5d93facbb6f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat Copper dioleate,1120-44-1,"The pivotal repeat dose study was a 90-day study by the oral route with copper sulphate pentahydrate. In rats and mice, ingestion of copper sulphate pentahydrate produced forestomach lesions that could be to the irritant effects of the compound. The NOAEL for this effect was 16.7 mg Cu/kg bw/day in rats and 97 and 126 mg Cu/kg bw/day in male and female mice respectively. In rats inflammation of the liver was observed. The NOAEL’s for liver and kidney damage were 16.7 mg Cu/kg bw/day in rats. This is the pivotal study and the NOAEL of 167 mg Copper dioleate/kg bw/day will be used in the risk characterisation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7fa5e733-a3bd-4afb-9ed8-1979a2182816/documents/c5b39272-c0f1-4dcb-837b-c1cb4aa8949f_03f948f4-564d-4326-b91a-78df0b13b0d5.html,,,,,, Copper dioleate,1120-44-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7fa5e733-a3bd-4afb-9ed8-1979a2182816/documents/c5b39272-c0f1-4dcb-837b-c1cb4aa8949f_03f948f4-564d-4326-b91a-78df0b13b0d5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,167 mg/kg bw/day,,rat Copper dioleate,1120-44-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7fa5e733-a3bd-4afb-9ed8-1979a2182816/documents/350bdd9d-9eb5-4bb7-b713-cadf5d808697_03f948f4-564d-4326-b91a-78df0b13b0d5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, copper(2+) hydroxide nitrate,12158-75-7,"n summary, under the exposure conditions employed in this study, ingestination of cupric sulfate in drinking water or feed produced hyperplasia and hyoerkeratois of the forestomach mucossia (irritant effect of the substance).There is a copper accumulation in liver, kidney tissue and the plasma.There was determined a NOEL value from 1000ppm for rat ant 2000ppm for mice. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2c8ab72-154b-41b9-a703-dc6f131f9e59/documents/IUC5-cbe41674-bfe7-450a-a4ef-91aef50f875f_13bb83e8-f776-4bb6-9e78-9154b11e06d2.html,,,,,, copper(2+) hydroxide nitrate,12158-75-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2c8ab72-154b-41b9-a703-dc6f131f9e59/documents/IUC5-cbe41674-bfe7-450a-a4ef-91aef50f875f_13bb83e8-f776-4bb6-9e78-9154b11e06d2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat copper(2+) hydroxide nitrate,12158-75-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2c8ab72-154b-41b9-a703-dc6f131f9e59/documents/IUC5-3f32e05f-ae09-4ad5-b3c8-97b3521ff91e_13bb83e8-f776-4bb6-9e78-9154b11e06d2.html,,oral,LD50,501 mg/kg bw,, copper(2+) hydroxide nitrate,12158-75-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2c8ab72-154b-41b9-a703-dc6f131f9e59/documents/IUC5-3f32e05f-ae09-4ad5-b3c8-97b3521ff91e_13bb83e8-f776-4bb6-9e78-9154b11e06d2.html,,dermal,LD50,"2,001 mg/kg bw",, Copper sulphide,1317-40-4,"The pivotal repeat dose study was a 90-day study by the oral route with copper sulphate pentahydrate. In rats and mice, ingestion of copper sulphate pentahydrate produced forestomach lesions that could be to the irritant effects of the compound. The NOAEL for this effect was 16.7 mg Cu/kg bw/day in rats and 97 and 126 mg Cu/kg bw/day in male and female mice respectively. In rats inflammation of the liver was observed. The NOAEL’s for liver and kidney damage were 16.7 mg Cu/kg bw/day in rats. This is the pivotal study and the NOAEL of 16.7 mg Cu/kg bw/day will be used in the risk characterisation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a96158ee-ecb3-44f9-b9da-b4f18af0fdb5/documents/4bdeb524-e55e-43c6-9f2c-e18d44f68fe8_31501574-b165-4c88-acfe-f20e3ae30b21.html,,,,,, Copper sulphide,1317-40-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a96158ee-ecb3-44f9-b9da-b4f18af0fdb5/documents/4bdeb524-e55e-43c6-9f2c-e18d44f68fe8_31501574-b165-4c88-acfe-f20e3ae30b21.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat Copper(2+) neodecanoate,68084-48-0,"ORAL : The pivotal repeat dose study was a 90-day study by the oral route with copper sulphate pentahydrate. In rats and mice, ingestion of copper sulphate pentahydrate produced forestomach lesions that could be to the irritant effects of the compound. The NOAEL for this effect was 16.7 mg Cu/kg bw/day in rats and 97 and 126 mg Cu/kg bw/day in male and female mice respectively. In rats inflammation of the liver was observed. The NOAEL’s for liver and kidney damage were 16.7 mg Cu/kg bw/day in rats. This is the pivotal study and the NOAEL of 16.7 mg Cu/kg bw/day will be used in the risk characterisation. INHALATION : the pivotal study in the 28 days rat inhalation study on Cu2O. The main conclusion is observed effects at all doses (0.2-2 mg/m3) but no adverse effects at the highest dose tested (2 mg/m3). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/860d8d04-866b-4527-be75-4f6a64f114fe/documents/840c372e-ff31-4d4c-9d70-cf2b911ac2bc_0bcc785a-a058-48be-ac7c-7c6cd798526b.html,,,,,, Copper(2+) neodecanoate,68084-48-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/860d8d04-866b-4527-be75-4f6a64f114fe/documents/840c372e-ff31-4d4c-9d70-cf2b911ac2bc_0bcc785a-a058-48be-ac7c-7c6cd798526b.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,>= 1.6 mg/m3,,rat Copper(2+) neodecanoate,68084-48-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/860d8d04-866b-4527-be75-4f6a64f114fe/documents/840c372e-ff31-4d4c-9d70-cf2b911ac2bc_0bcc785a-a058-48be-ac7c-7c6cd798526b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat Copper(2+) neodecanoate,68084-48-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/860d8d04-866b-4527-be75-4f6a64f114fe/documents/840c372e-ff31-4d4c-9d70-cf2b911ac2bc_0bcc785a-a058-48be-ac7c-7c6cd798526b.html,Repeated dose toxicity – local effects,inhalation,NOAEC,>= 1.6 mg/m3,no adverse effect observed,rat Copper(2+) neodecanoate,68084-48-0,"No acute toxicity studies with copper (2+) neodecanoate are available, thus the acute toxicity will be addressed with existing data on the individual moieties copper and neodecanoic acid. The LD50 cutoff value for neodecanoic acid is 1000 mg/kg bw. The oral LD50 value for copper is 122.5 mg Cu/kg bw. Further, copper sulphate is legally classified (Regulation 1272/2008; Index No. 029 -004 -00 -0) for acute oral toxicity category 4. The calculated LD50 for copper (2+) neodecanoate is 300 < LD50 ≤ 2000 mg/kg bw, thus the substance is classified according to regulation (EC) 1272/2008 for acute oral toxicity category 4 (H302: Harmful if swallowed). Signs of acute dermal toxicity are not expected for copper (2+) neodecanoate, since the LD50 for both constituents (copper and neodecanoic acid) is above 2000 mg/kg bw. Based on the above given information, copper (2+) neodecanoate is not expected to show any acute toxic effects via dermal route and does not require a classification for acute dermal toxicity (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/860d8d04-866b-4527-be75-4f6a64f114fe/documents/5e37da45-509b-42c3-b5cb-f1dd613b070d_0bcc785a-a058-48be-ac7c-7c6cd798526b.html,,,,,, Copper(2+) tetrafluoroborate(1-),38465-60-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): data source: CuCl_2 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/694a6810-4e01-4a17-8d0e-70ae064991f9/documents/d1398073-839f-46e7-ae3c-69a3dd2c2088_6c19d3df-6269-4dc7-9ce4-9ddb7b770594.html,,,,,, Copper(2+) tetrafluoroborate(1-),38465-60-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/694a6810-4e01-4a17-8d0e-70ae064991f9/documents/d1398073-839f-46e7-ae3c-69a3dd2c2088_6c19d3df-6269-4dc7-9ce4-9ddb7b770594.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat bis[1-carbamimidoyl-kN'-urea-kO)]copper(2+) dinitrate,1071838-81-7,"Oral repeated dose toxicity:• No observed adverse effect at 200 mg/kg. Higher potassium level in females, albumin/globulin ratio in both sexes, minor histological changes, soiled urogenital, anal or buccal regions, squamous cell hyperplasia in the stomach were noted but not considered to be adverse.• Target organs: haematology, liver, kidney, gastro-intestinal tract. • Clinical signs at 700/500 mg/kg: four treatment-related mortalities, lower body weight gains (associated with lower food consumption), hunched posture, piloerection, breathing difficulties, soiled urogenital, anal or buccal regions, increase of abdomen size, higher platelets count and reticulocytes percentages, lower MCV and MCH, lower haemoglobin concentration, packed cell volume and prolonged mean prothrombin time, higher aspartate aminotransferase and alanine aminotransferase activities, higher potassium level and albumin/globulin ratio.• Macroscopic adverse effect at 700/500 mg/kg: Squamous cell hyperplasia at the level of the limiting ridge in the stomach and dilatation/distension of various parts of the small or large intestine.• Microscopic adverse effect at 700/500 mg/kg: hyaline droplets and tubular degeneration/regeneration in kidneys and single cell necrosis with inflammatory cell foci in the liver. In the gastro-intestinal tract, hyperplasia at the level of the limiting ridge, atrophy of the glandular portion of the stomach and hypertrophy or villous atrophy of the small intestine. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21090edb-d706-425b-acc5-759804fe816a/documents/IUC5-afae0457-cb51-4892-85ab-41d936e97afb_e3c242c6-3fea-46f8-841d-a24a0e9b720a.html,,,,,, bis[1-carbamimidoyl-kN'-urea-kO)]copper(2+) dinitrate,1071838-81-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21090edb-d706-425b-acc5-759804fe816a/documents/IUC5-afae0457-cb51-4892-85ab-41d936e97afb_e3c242c6-3fea-46f8-841d-a24a0e9b720a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat bis[1-carbamimidoyl-kN'-urea-kO)]copper(2+) dinitrate,1071838-81-7,"Acute oral toxicity: 300 mg/kg < LD50 < 2000 mg/kg, OECD guideline 423, GLP compliantAcute inhalation toxicity: data waiving (study scientifically unjustified), very low vapour pressure (0.0000009 Pa ) and only 10 % of particles are below 13.5 µM (more than 90 % of particles are non inhalable).Acute dermal toxicity: LD50 > 2000 mg/kg, OECD guideline 402, GLP compliant ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21090edb-d706-425b-acc5-759804fe816a/documents/IUC5-00d927c8-5cab-44cb-8d81-26a281a21d14_e3c242c6-3fea-46f8-841d-a24a0e9b720a.html,,,,,, bis[1-carbamimidoyl-kN'-urea-kO)]copper(2+) dinitrate,1071838-81-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21090edb-d706-425b-acc5-759804fe816a/documents/IUC5-00d927c8-5cab-44cb-8d81-26a281a21d14_e3c242c6-3fea-46f8-841d-a24a0e9b720a.html,,oral,LD50,300 mg/kg bw,adverse effect observed, bis[1-carbamimidoyl-kN'-urea-kO)]copper(2+) dinitrate,1071838-81-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21090edb-d706-425b-acc5-759804fe816a/documents/IUC5-00d927c8-5cab-44cb-8d81-26a281a21d14_e3c242c6-3fea-46f8-841d-a24a0e9b720a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Copper, [[[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]phenyl]amino]sulfonyl]-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., sodium salts",71786-55-5, LD50 > 5000 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/456e48d3-eab2-4eaa-9846-f99b0d087cc1/documents/877e8c43-95bd-437f-ac25-2d6ec080349a_bad64b32-0b40-4594-a161-a7ebdf7c9539.html,,,,,, "Copper, [[[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]phenyl]amino]sulfonyl]-29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., sodium salts",71786-55-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/456e48d3-eab2-4eaa-9846-f99b0d087cc1/documents/877e8c43-95bd-437f-ac25-2d6ec080349a_bad64b32-0b40-4594-a161-a7ebdf7c9539.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, (1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)methyl derivs.",68411-06-3,"For the UVCB substance with a higher average substitution grade, a 14-day study in rats with 300 and 1000 mg/kg bw of the substance showed absence of toxicity. No indication of systemic uptake as determined via serum copper concentrations was observed. For support, data on the smaller copper phthalocyanine core (CAS 147-15-8) is used. It shows lack of effects in rats and mice upon subchronic feed exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f7d51eff-6012-46d8-820a-3625318baacc/documents/IUC5-2b03a6fe-6df5-4b1c-8a05-54bdae2ea852_b0490145-7344-4ee5-944f-80d582944e4b.html,,,,,, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, (1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)methyl derivs.",68411-06-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f7d51eff-6012-46d8-820a-3625318baacc/documents/IUC5-2b03a6fe-6df5-4b1c-8a05-54bdae2ea852_b0490145-7344-4ee5-944f-80d582944e4b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, (1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)methyl derivs.",68411-06-3, This UVCB substance is assessed as non hazardous for acute toxicity from experimental data in rats with another UVCB substance consisting of identical components. Both UVCB substances are poorly soluble nanomaterials. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7d51eff-6012-46d8-820a-3625318baacc/documents/IUC5-81b4b8b7-0f0b-43e5-bd7a-7a167100970d_b0490145-7344-4ee5-944f-80d582944e4b.html,,,,,, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, (1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)methyl derivs.",68411-06-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7d51eff-6012-46d8-820a-3625318baacc/documents/IUC5-81b4b8b7-0f0b-43e5-bd7a-7a167100970d_b0490145-7344-4ee5-944f-80d582944e4b.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, (1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)methyl derivs.",68411-06-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7d51eff-6012-46d8-820a-3625318baacc/documents/IUC5-81b4b8b7-0f0b-43e5-bd7a-7a167100970d_b0490145-7344-4ee5-944f-80d582944e4b.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, (1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)methyl derivs.",68411-06-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7d51eff-6012-46d8-820a-3625318baacc/documents/IUC5-81b4b8b7-0f0b-43e5-bd7a-7a167100970d_b0490145-7344-4ee5-944f-80d582944e4b.html,,inhalation,discriminating conc.,2 mg/m3,no adverse effect observed, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(1-methylethoxy)propyl]amino]sulfonyl derivs.",81457-65-0,No adverse effects were observed in a GLP-compliant gavage study with rats that followed OECD testing guideline 422 (BASF 2013). Feces showed the colour of the test item indicated gastrointestinal passage. The highest tested dose was the limit dose required by the guideline (1000 mg/kg bw). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/869fe42c-0555-4dad-a3a0-959b4d518456/documents/IUC5-400b758e-0db0-414b-b8dc-ad7b87343572_44ee23cf-3519-4805-91b6-118772feee8a.html,,,,,, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(1-methylethoxy)propyl]amino]sulfonyl derivs.",81457-65-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/869fe42c-0555-4dad-a3a0-959b4d518456/documents/IUC5-400b758e-0db0-414b-b8dc-ad7b87343572_44ee23cf-3519-4805-91b6-118772feee8a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(1-methylethoxy)propyl]amino]sulfonyl derivs.",81457-65-0,"The substance is virtually nontoxic after a single administration as an aqueous suspension as rats survived application of 10000 mg/kg bw without showing signs of intoxication (Ciba-Geigy Ltd. 1972). Dosing of hamsters with an excessive solution in oil resulted in mortality at 3000, but not at 1000 mg/kg bw (Ciba-Geigy Ltd. 1982). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/869fe42c-0555-4dad-a3a0-959b4d518456/documents/IUC5-af12476e-95ae-41fe-b12a-a3ef34ba351b_44ee23cf-3519-4805-91b6-118772feee8a.html,,,,,, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(1-methylethoxy)propyl]amino]sulfonyl derivs.",81457-65-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/869fe42c-0555-4dad-a3a0-959b4d518456/documents/IUC5-af12476e-95ae-41fe-b12a-a3ef34ba351b_44ee23cf-3519-4805-91b6-118772feee8a.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(dimethylamino)propyl]amino]sulfonyl derivs.",68411-04-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Overall, based on data from repeated dose studies, there is no evidence of a toxicological relevant absorption of C.I. Direct Blue 264. The no observed adverse effect level (NOAEL) of Direct Blue 264 is considered to be 1000 mg/kg body weight/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83734f81-9530-4c98-a822-a7958ecff8c0/documents/532862dc-d844-4944-ab71-68c1784ed965_6b5542d9-c561-4ff0-ba1a-e32515dbf777.html,,,,,, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(dimethylamino)propyl]amino]sulfonyl derivs.",68411-04-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83734f81-9530-4c98-a822-a7958ecff8c0/documents/532862dc-d844-4944-ab71-68c1784ed965_6b5542d9-c561-4ff0-ba1a-e32515dbf777.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(dimethylamino)propyl]amino]sulfonyl derivs.",68411-04-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83734f81-9530-4c98-a822-a7958ecff8c0/documents/816d46e4-6ec0-4e2f-a2b5-5056960a0f2a_6b5542d9-c561-4ff0-ba1a-e32515dbf777.html,,oral,LD50,"5,000 mg/kg bw",adverse effect observed, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(dimethylamino)propyl]amino]sulfonyl derivs.",68411-04-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83734f81-9530-4c98-a822-a7958ecff8c0/documents/816d46e4-6ec0-4e2f-a2b5-5056960a0f2a_6b5542d9-c561-4ff0-ba1a-e32515dbf777.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(dimethylamino)propyl]amino]sulfonyl derivs., acetates",90295-19-5, The NOAEL (No Observed Adverse Effect Level) for oral repeated dose toxicity was established as 125 mg/kg body weight/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe30698d-859a-4231-9546-9436d018430e/documents/77fff29c-a802-4665-a9e6-4fd795a9e122_0849e9b6-7197-48a8-87f8-f5505f4adc69.html,,,,,, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(dimethylamino)propyl]amino]sulfonyl derivs., acetates",90295-19-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe30698d-859a-4231-9546-9436d018430e/documents/77fff29c-a802-4665-a9e6-4fd795a9e122_0849e9b6-7197-48a8-87f8-f5505f4adc69.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(dimethylamino)propyl]amino]sulfonyl derivs., acetates",90295-19-5," LD50 oral > 2000 mg/kg bw Dermal and inhalation exposure is unlikely, thus no acute toxicity value is available and no further investigation is required. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe30698d-859a-4231-9546-9436d018430e/documents/f8eeaccb-eec4-4614-9c10-a975e53dc335_0849e9b6-7197-48a8-87f8-f5505f4adc69.html,,,,,, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(dimethylamino)propyl]amino]sulfonyl derivs., acetates",90295-19-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe30698d-859a-4231-9546-9436d018430e/documents/f8eeaccb-eec4-4614-9c10-a975e53dc335_0849e9b6-7197-48a8-87f8-f5505f4adc69.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, [[3-(dimethylamino)propyl]amino]sulfonyl derivs., acetates",90295-19-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe30698d-859a-4231-9546-9436d018430e/documents/f8eeaccb-eec4-4614-9c10-a975e53dc335_0849e9b6-7197-48a8-87f8-f5505f4adc69.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., ammonium sodium salts",90295-08-2, NOAEL (49d) (males and females): 125 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e84ca8a-1fab-4e39-b2ee-b3f2c2d2c25f/documents/967c4f0a-afcf-4039-bafd-50c7c9585f42_645c2009-34fa-4029-8e8f-42cd9ac14b11.html,,,,,, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., ammonium sodium salts",90295-08-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e84ca8a-1fab-4e39-b2ee-b3f2c2d2c25f/documents/967c4f0a-afcf-4039-bafd-50c7c9585f42_645c2009-34fa-4029-8e8f-42cd9ac14b11.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., ammonium sodium salts",90295-08-2, Oral LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e84ca8a-1fab-4e39-b2ee-b3f2c2d2c25f/documents/f1a94ff9-13b3-4474-bdd1-790e293c8f55_645c2009-34fa-4029-8e8f-42cd9ac14b11.html,,,,,, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., ammonium sodium salts",90295-08-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e84ca8a-1fab-4e39-b2ee-b3f2c2d2c25f/documents/f1a94ff9-13b3-4474-bdd1-790e293c8f55_645c2009-34fa-4029-8e8f-42cd9ac14b11.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., sodium salts",90295-11-7, NOAEL (49d) (males and females): 125 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f1aa87a-283a-42c7-999a-ae7f6ffb6291/documents/fc4cd70e-d852-4cc3-b218-e46b484e912e_b536f316-bf9f-448b-a141-ca14a8dcba3b.html,,,,,, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., sodium salts",90295-11-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f1aa87a-283a-42c7-999a-ae7f6ffb6291/documents/fc4cd70e-d852-4cc3-b218-e46b484e912e_b536f316-bf9f-448b-a141-ca14a8dcba3b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, aminosulfonyl sulfo derivs., sodium salts",90295-11-7, Oral LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f1aa87a-283a-42c7-999a-ae7f6ffb6291/documents/4406b22a-bafd-4c46-b41e-8772a68b8a20_b536f316-bf9f-448b-a141-ca14a8dcba3b.html,,,,,, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)amino]-5-nitrobenzenesulfonic acid, sodium salts",73378-63-9, Acute toxicity: via oral route The LD50 of Everlan SL53 was greater than 2000 mg/kg B.W. (OECD TG423). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/608505e5-a8c7-4d28-98d9-8cfe3d38c480/documents/d14f5a20-5803-450e-ad0f-1f06c4b68fcd_895867c2-acdf-4229-ab87-9a398a9d5718.html,,,,,, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, chlorosulfonyl derivs., reaction products with 2-[(4-aminophenyl)amino]-5-nitrobenzenesulfonic acid, sodium salts",73378-63-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/608505e5-a8c7-4d28-98d9-8cfe3d38c480/documents/d14f5a20-5803-450e-ad0f-1f06c4b68fcd_895867c2-acdf-4229-ab87-9a398a9d5718.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, sulfo [[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]sulfonyl derivs.",73049-92-0,No adverse effects were observed up to the limit dose tested. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c33c74e5-bd6d-4f75-bc74-846bc55342b9/documents/IUC5-c0bf9eb0-1348-4030-8e63-4b8af7616a56_c0c8cfad-c830-4e42-8572-1a783cfb4d3f.html,,,,,, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, sulfo [[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]sulfonyl derivs.",73049-92-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c33c74e5-bd6d-4f75-bc74-846bc55342b9/documents/IUC5-c0bf9eb0-1348-4030-8e63-4b8af7616a56_c0c8cfad-c830-4e42-8572-1a783cfb4d3f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, sulfo [[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]sulfonyl derivs.",73049-92-0,Reactive Blue 21 is practically non-toxic. The LD50 for oral administration is above 5000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c33c74e5-bd6d-4f75-bc74-846bc55342b9/documents/IUC5-38f812d2-51c4-4ee2-90ba-4be9217ff298_c0c8cfad-c830-4e42-8572-1a783cfb4d3f.html,,,,,, "Copper, [29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32]-, sulfo [[4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]amino]sulfonyl derivs.",73049-92-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c33c74e5-bd6d-4f75-bc74-846bc55342b9/documents/IUC5-38f812d2-51c4-4ee2-90ba-4be9217ff298_c0c8cfad-c830-4e42-8572-1a783cfb4d3f.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Copper, diammine[5,5'-bi-1H-tetrazolato(2-)-kN1, kN1']",538313-26-7," A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test was realised on adult Wistar rats (n=12 animals/sex/experimental group) which were daily treated orally by gavage with CuDABT suspensions at 0 and 1000 mg/kg/day up to 55 consecutive days. Mortality, body weight, clinical signs, food consumption, and sensorimotor abilities were recorded aware the experimental period. Males and females were also mated, in order to evaluate the effects of the test item on developmental parameters in the following generation. The repeated CuDABT administration lead to observe sex-dependant difference between animals exposed to the substance and controls. In adults, body weight, food consumption, clinical signs, hematological and biochemical parameters, and coagulation time have varied. In the F1 generation, the anogenital distance and the percentage of nipple retention were also different between the two groups. By cons, no disruption of the sensorimotor abilities and the reproductive function has been observed in adults, nor macroscopic and microscopic post-mortem abnormalities in parents and pups. These findings have conduct to punctual discrepancies, which haven't reveal a biological disruption. No critical trouble having being demonstrated, these outcomes haven't been judged as adverse effects. In accordance with the EC No. 1272/2008 regulation, the repeated oral exposure to CuDABT is considered as non-toxic for the reproduction and the development in rats at the dose of 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba187a42-45a7-46bb-a50d-babb50ad1d5e/documents/58968688-61ad-4507-b278-b72cc87a231a_ff8b3433-9545-49af-8bef-e0a9c0afa327.html,,,,,, "Copper, diammine[5,5'-bi-1H-tetrazolato(2-)-kN1, kN1']",538313-26-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba187a42-45a7-46bb-a50d-babb50ad1d5e/documents/58968688-61ad-4507-b278-b72cc87a231a_ff8b3433-9545-49af-8bef-e0a9c0afa327.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Copper, diammine[5,5'-bi-1H-tetrazolato(2-)-kN1, kN1']",538313-26-7," According to acute oral toxicity assay, copper Diammine Bitetrazole (CuDABT) is considered as non-toxic or in UN GHS No category (LD50 > 2,000 mg/kg). No hazard statement or signalling is required. Inhalation acute toxicity assay is not necessary because of the high particle size and very low vapor pressure. Dermal acute toxicity assay is not necessary because no adverse effect was observed in the acute toxicity assay by oral route and the skin sensitization in vivo study shows no systemic effect. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba187a42-45a7-46bb-a50d-babb50ad1d5e/documents/daf67929-19bd-4bdd-a9d6-157d134e8487_ff8b3433-9545-49af-8bef-e0a9c0afa327.html,,,,,, "Copper, diammine[5,5'-bi-1H-tetrazolato(2-)-kN1, kN1']",538313-26-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba187a42-45a7-46bb-a50d-babb50ad1d5e/documents/daf67929-19bd-4bdd-a9d6-157d134e8487_ff8b3433-9545-49af-8bef-e0a9c0afa327.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Mg-cordierite, aluminium magnesium silicate (4:2:5)",1302-88-1," Repeated-dose toxicity study by oral route has been performed on synthetic amorphous silica (SAS) as a read-across substance representing a worst-case scenario, according to a method similar to 453, on rats which is the preferred species for this study. The NOAEL was 5% of the substance in diet, which corresponds to a dose between 1700 and 3000 mg/kg bw/day for both male and female rats and is the highest concentration evaluation during this study. As it is the lowest actual dose received, the NOAEL for repeated dose toxicity by oral route has been determined to be 1600 mg/kg bw/day. Repeated-dose toxicity study by oral route has been performed on synthetic SAS as a read-across substance representing a worst-case scenario, according to a method similar to 413, on rats which is the preferred species for this study. The NOAEL has been determined to be 31 mg/m3 for systemic effects, and 1.3 mg/m3 for local effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98c35a09-aec6-4095-add0-604aa6d43c08/documents/IUC5-ca3e6fad-0947-4668-90b7-1902600cb380_9f477076-79d9-4a64-afdc-45c90c4fbb88.html,,,,,, "Mg-cordierite, aluminium magnesium silicate (4:2:5)",1302-88-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98c35a09-aec6-4095-add0-604aa6d43c08/documents/IUC5-ca3e6fad-0947-4668-90b7-1902600cb380_9f477076-79d9-4a64-afdc-45c90c4fbb88.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,31 mg/m3,,rat "Mg-cordierite, aluminium magnesium silicate (4:2:5)",1302-88-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98c35a09-aec6-4095-add0-604aa6d43c08/documents/IUC5-ca3e6fad-0947-4668-90b7-1902600cb380_9f477076-79d9-4a64-afdc-45c90c4fbb88.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,700 mg/kg bw/day",,rat "Mg-cordierite, aluminium magnesium silicate (4:2:5)",1302-88-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98c35a09-aec6-4095-add0-604aa6d43c08/documents/IUC5-ca3e6fad-0947-4668-90b7-1902600cb380_9f477076-79d9-4a64-afdc-45c90c4fbb88.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1.3 mg/m3,adverse effect observed,rat "Mg-cordierite, aluminium magnesium silicate (4:2:5)",1302-88-1," The acute toxicity study by oral route was conducted on the registered substance according to OECD Testing Guideline 420. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures. The acute toxicity study by inhalation route was conducted on the registered substance according to OECD Testing Guideline 403. The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 5 mg/l (air). The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98c35a09-aec6-4095-add0-604aa6d43c08/documents/IUC5-1363af78-6735-46d3-a4bd-c4570b6e9df4_9f477076-79d9-4a64-afdc-45c90c4fbb88.html,,,,,, "Mg-cordierite, aluminium magnesium silicate (4:2:5)",1302-88-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98c35a09-aec6-4095-add0-604aa6d43c08/documents/IUC5-1363af78-6735-46d3-a4bd-c4570b6e9df4_9f477076-79d9-4a64-afdc-45c90c4fbb88.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Mg-cordierite, aluminium magnesium silicate (4:2:5)",1302-88-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98c35a09-aec6-4095-add0-604aa6d43c08/documents/IUC5-1363af78-6735-46d3-a4bd-c4570b6e9df4_9f477076-79d9-4a64-afdc-45c90c4fbb88.html,,inhalation,LC50,"5,000 mg/m3",adverse effect observed, "Corn, steep liquor",66071-94-1,"In accordance with section 1 of Annex IX, the repeated dose toxicity studies by oral exposure, dermal exposure, and inhalation exposure (sections 8.6.1. and 8.6.2.), do not need to be conducted as corn steep liquor (CSL) consists of all-natural, water soluble components (crude proteins, amino acids, minerals, vitamins, reducing sugars, organic acids, enzymes and other elemental nutrients), that have been extracted by soaking corn in water, along with a very small amount of sulfurous acid (<0.01%). CSL has a long history of safe use as an added source of nutrition in animal feed, in fermentation processes, and in antibiotic production. On this basis, CSL is not expected to cause adverse toxic effects to humans. This expectation is supported by the demonstrated lack of repeated dose toxicity of lactic acid - a major component of CSL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b96d337-efc9-4826-99ba-ff516c6b06f9/documents/IUC5-abdec6ec-4707-4260-93b9-220e300e624e_766347f6-58b5-499e-9e32-82907e1ae925.html,,,,,, "Corn, steep liquor",66071-94-1,"In accordance with section 1 of Annex IX, the acute toxicity studies by the oral route (section 8.5.1.), inhalation route (section 8.5.2.), and dermal route (section 8.5.3.), do not need to be conducted as corn steep liquor (CSL) consists of all-natural, water soluble components (crude proteins, amino acids, minerals, vitamins, reducing sugars, organic acids, enzymes and other elemental nutrients), that have been extracted by soaking corn in water, along with a very small amount of sulfurous acid (<0.01%). CSL has a long history of safe use as an added source of nutrition in animal feed, in fermentation processes, and in antibiotic production. On this basis, CSL is not expected to cause adverse toxic effects to humans. This expectation is supported by the demonstrated lack of acute toxicity of lactic acid - a major component of CSL. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b96d337-efc9-4826-99ba-ff516c6b06f9/documents/IUC5-24c5812c-3fec-43e9-ad9d-00c1d10507f4_766347f6-58b5-499e-9e32-82907e1ae925.html,,,,,, "Cryolite, tripotassium",60996-20-5," Based on read-across from multiconstituent aluminium potassium fluoride, the  most critical effects of potassium cryolite after repeated inhalation exposure are expected to be effects on the lungs. Based on the available study, the overall NOAEC for local effects is 1.21 mg/m3. The overall systemic NOAEC is >3.08 mg/m3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ed41a96-f52d-477c-a3be-c87c2f16df7f/documents/fb4d5464-e453-48f9-aa9b-e8dd1ee87e7c_3dd4b7bf-f2fe-46a7-a14b-6598a979680b.html,,,,,, "Cryolite, tripotassium",60996-20-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ed41a96-f52d-477c-a3be-c87c2f16df7f/documents/fb4d5464-e453-48f9-aa9b-e8dd1ee87e7c_3dd4b7bf-f2fe-46a7-a14b-6598a979680b.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,3.08 mg/m3,,rat "Cryolite, tripotassium",60996-20-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ed41a96-f52d-477c-a3be-c87c2f16df7f/documents/fb4d5464-e453-48f9-aa9b-e8dd1ee87e7c_3dd4b7bf-f2fe-46a7-a14b-6598a979680b.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1.21 mg/m3,adverse effect observed,rat "Cryolite, tripotassium",60996-20-5, The oral LD50 exceeds 2000 mg/kg body weight. The inhalatory LC50 (4 hours) was determined at 1 -5 mg/L for male and female rats based on read-across from multiconstituent aluminium potassium fluoride. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ed41a96-f52d-477c-a3be-c87c2f16df7f/documents/d16c7708-bfbb-4c53-b53c-6b99a4226550_3dd4b7bf-f2fe-46a7-a14b-6598a979680b.html,,,,,, Cesium Tungsten Suboxide,189619-69-0," The test item, Cesium Tungsten Oxide, was administered to 6 females Wistar rats at a limit dose of 2000 mg/kg. The limit dose did not cause death or evident signs of toxicity. During the follow up period, no other signs of intoxication, change of health, nor any other adverse reactions were displayed. The body weight of animals increased between week 1 and week 2, except 1 animal. The macroscopical examination of the animals at the end of the study did not reveal treatment-related changes. The LD50 of the test item was thus determined to be greater than 2000 mg/kg body weight after single oral administration to Wistar rats. The test item Cesium Tungsten Oxide does not meet GHS classification criteria as based on study results the LD50 cut off value is equal to or greater than 5000 mg/kg body weight, after single oral administration to Wistar rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48f172b5-9972-43f1-b40d-63d095199314/documents/e83105e3-85b1-47f0-beda-904d80e18ff6_1fe5cae8-a8a3-4ec3-bc5b-5a5f859cb710.html,,,,,, Cesium Tungsten Suboxide,189619-69-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48f172b5-9972-43f1-b40d-63d095199314/documents/e83105e3-85b1-47f0-beda-904d80e18ff6_1fe5cae8-a8a3-4ec3-bc5b-5a5f859cb710.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Cuprate(2-), [μ-[[3,3'-[methylenebis[(4,6-dihydroxy-3,1-phenylene)azo]]bis[4-hydroxy-5-nitrobenzenesulfonato]](6-)]]di-, sodium",85186-15-8, LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29042eca-fd8a-46e9-9396-fbb249f7ba97/documents/8007e161-8701-458f-9eed-ab5d1777a075_cf32527d-94e0-4c8d-a6ae-731432a557ca.html,,,,,, "Cuprate(2-), [μ-[[3,3'-[methylenebis[(4,6-dihydroxy-3,1-phenylene)azo]]bis[4-hydroxy-5-nitrobenzenesulfonato]](6-)]]di-, sodium",85186-15-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29042eca-fd8a-46e9-9396-fbb249f7ba97/documents/8007e161-8701-458f-9eed-ab5d1777a075_cf32527d-94e0-4c8d-a6ae-731432a557ca.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "[mu-[[3,3'-[(1-oxido-1,2-diazenediyl)bis[[2-(hydroxy-kappa-O)- 4,1-phenylene]-2,1-diazenediyl-kappa-N1]]bis[4-(hydroxy-kappa-O)-2,7- naphthalenedisulfonato]](8-)]]dicopper, tetra sodium ammonium salt",1713250-52-2,In a oral subacute repeated dose toxicity study a NOAEL of 100 mg/kg bw was determined for analogue substance 1 which is the analogue of the test article. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/392d48c4-47e8-4f89-900f-a6243ed26381/documents/IUC5-d58fbc70-b376-4a03-a362-16ef56a4d3fc_d2a52a41-89e3-4c68-8671-2095e0faafdc.html,,,,,, "[mu-[[3,3'-[(1-oxido-1,2-diazenediyl)bis[[2-(hydroxy-kappa-O)- 4,1-phenylene]-2,1-diazenediyl-kappa-N1]]bis[4-(hydroxy-kappa-O)-2,7- naphthalenedisulfonato]](8-)]]dicopper, tetra sodium ammonium salt",1713250-52-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/392d48c4-47e8-4f89-900f-a6243ed26381/documents/IUC5-d58fbc70-b376-4a03-a362-16ef56a4d3fc_d2a52a41-89e3-4c68-8671-2095e0faafdc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "[mu-[[3,3'-[(1-oxido-1,2-diazenediyl)bis[[2-(hydroxy-kappa-O)- 4,1-phenylene]-2,1-diazenediyl-kappa-N1]]bis[4-(hydroxy-kappa-O)-2,7- naphthalenedisulfonato]](8-)]]dicopper, tetra sodium ammonium salt",1713250-52-2,oral acute toxicity:LD50 value is 2900 mg/kg bw (rat) based on the test material (approx. 95% act. ingr.)dermal acute toxicity:The LD50 value was determined to be greater than 2000 mg/kg bw in male and female rats based on test material (> 90% act. ingr.). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/392d48c4-47e8-4f89-900f-a6243ed26381/documents/IUC5-7440a0e7-2325-4e28-83ee-7022baae3e90_d2a52a41-89e3-4c68-8671-2095e0faafdc.html,,,,,, "[mu-[[3,3'-[(1-oxido-1,2-diazenediyl)bis[[2-(hydroxy-kappa-O)- 4,1-phenylene]-2,1-diazenediyl-kappa-N1]]bis[4-(hydroxy-kappa-O)-2,7- naphthalenedisulfonato]](8-)]]dicopper, tetra sodium ammonium salt",1713250-52-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/392d48c4-47e8-4f89-900f-a6243ed26381/documents/IUC5-7440a0e7-2325-4e28-83ee-7022baae3e90_d2a52a41-89e3-4c68-8671-2095e0faafdc.html,,oral,LD50,"2,900 mg/kg bw",no adverse effect observed, "[mu-[[3,3'-[(1-oxido-1,2-diazenediyl)bis[[2-(hydroxy-kappa-O)- 4,1-phenylene]-2,1-diazenediyl-kappa-N1]]bis[4-(hydroxy-kappa-O)-2,7- naphthalenedisulfonato]](8-)]]dicopper, tetra sodium ammonium salt",1713250-52-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/392d48c4-47e8-4f89-900f-a6243ed26381/documents/IUC5-7440a0e7-2325-4e28-83ee-7022baae3e90_d2a52a41-89e3-4c68-8671-2095e0faafdc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Cuprate(4-), [2-[[[[2-hydroxy-3-sulfo-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]phenylmethyl]azo]-4-sulfobenzoato(6-)]-, sodium",90341-71-2,"The 28-day study with a structural analogue revealed no sytemic toxic effects of the test substance at 200 mg/kg bw. The NOAEL of 200 mg/kg bw was based on local effects of a substance overload on the stomach of the rats, especially the limiting ridge between forestomach and glandular stomach, a structure, not present in humans. Hence, this effect is of no consequence for human oral exposure to the substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ab50e74-8c40-4ad1-854b-53bb1fdebdda/documents/IUC5-58fbdf83-74f9-4aea-99ce-a400f9b24a1e_aabd076f-4f1a-47c5-b585-571619288e99.html,,,,,, "Cuprate(4-), [2-[[[[2-hydroxy-3-sulfo-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]phenylmethyl]azo]-4-sulfobenzoato(6-)]-, sodium",90341-71-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ab50e74-8c40-4ad1-854b-53bb1fdebdda/documents/IUC5-58fbdf83-74f9-4aea-99ce-a400f9b24a1e_aabd076f-4f1a-47c5-b585-571619288e99.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Cuprate(4-), [2-[[[[2-hydroxy-3-sulfo-5-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]azo]phenylmethyl]azo]-4-sulfobenzoato(6-)]-, sodium",90341-71-2,Substance is practically not toxic ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ab50e74-8c40-4ad1-854b-53bb1fdebdda/documents/IUC5-b6d1503e-5a6a-4888-9ab3-98ae7384873c_aabd076f-4f1a-47c5-b585-571619288e99.html,,,,,, "Reaction product of copper phthalocyanine, chlorosulphuric acid, 2-aminobenzene-1,4-disulphonic acid, 2,4,6-trichloro-1,3,5-triazine,sodium hydroxide",149343-84-0," Repeated dose toxicity: oral - 28 day ""No Observed Adverse Effect Level"" (NOAEL) is considered to be 150 mg active ingredient/kg/day for animals of either sex. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88011352-ffc1-4003-8476-144520ffc077/documents/12544c0b-c149-44e7-b33f-2d399eb987f4_c1f0750c-38be-41e5-a73f-161a07a94674.html,,,,,, "Reaction product of copper phthalocyanine, chlorosulphuric acid, 2-aminobenzene-1,4-disulphonic acid, 2,4,6-trichloro-1,3,5-triazine,sodium hydroxide",149343-84-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88011352-ffc1-4003-8476-144520ffc077/documents/12544c0b-c149-44e7-b33f-2d399eb987f4_c1f0750c-38be-41e5-a73f-161a07a94674.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Reaction product of copper phthalocyanine, chlorosulphuric acid, 2-aminobenzene-1,4-disulphonic acid, 2,4,6-trichloro-1,3,5-triazine,sodium hydroxide",149343-84-0, Acute toxicity: oral LD50: >2000 mg/kg bw (male/female Sprague -Dawley strain rat) Acute toxicity: dermal LD50: >2000 mg/kg bw (male/female Sprague-Dawley strain rat) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88011352-ffc1-4003-8476-144520ffc077/documents/f73c7ff5-59e2-4c06-a3e4-610d2589ff4d_c1f0750c-38be-41e5-a73f-161a07a94674.html,,,,,, "Reaction product of copper phthalocyanine, chlorosulphuric acid, 2-aminobenzene-1,4-disulphonic acid, 2,4,6-trichloro-1,3,5-triazine,sodium hydroxide",149343-84-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88011352-ffc1-4003-8476-144520ffc077/documents/f73c7ff5-59e2-4c06-a3e4-610d2589ff4d_c1f0750c-38be-41e5-a73f-161a07a94674.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction product of copper phthalocyanine, chlorosulphuric acid, 2-aminobenzene-1,4-disulphonic acid, 2,4,6-trichloro-1,3,5-triazine,sodium hydroxide",149343-84-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88011352-ffc1-4003-8476-144520ffc077/documents/f73c7ff5-59e2-4c06-a3e4-610d2589ff4d_c1f0750c-38be-41e5-a73f-161a07a94674.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Cuprate(4-), [μ-[[3,3'-[azobis[(2-hydroxy-4,1-phenylene)azo]]bis[4-hydroxy-6-[(3-sulfophenyl)amino]-2-naphthalenesulfonato]](8-)]]di-, ammonium sodium",72905-97-6,acute oral toxicity LD 50 = 9370 mg/kg bwacute dermal toxicity LD 50 = 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ae8465d-d0b8-4b5e-ad3d-d7d9187f4bed/documents/IUC5-fce09a1e-6e33-4e13-be28-4ce879301ce2_dcc2bcba-0bd6-4040-a122-b3569ffe11d5.html,,,,,, "Cuprate(4-), [μ-[[3,3'-[azobis[(2-hydroxy-4,1-phenylene)azo]]bis[4-hydroxy-6-[(3-sulfophenyl)amino]-2-naphthalenesulfonato]](8-)]]di-, ammonium sodium",72905-97-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ae8465d-d0b8-4b5e-ad3d-d7d9187f4bed/documents/IUC5-fce09a1e-6e33-4e13-be28-4ce879301ce2_dcc2bcba-0bd6-4040-a122-b3569ffe11d5.html,,oral,LD50,"9,370 mg/kg bw",no adverse effect observed, "Cuprate(4-), [μ-[[3,3'-[azobis[(2-hydroxy-4,1-phenylene)azo]]bis[4-hydroxy-6-[(3-sulfophenyl)amino]-2-naphthalenesulfonato]](8-)]]di-, ammonium sodium",72905-97-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ae8465d-d0b8-4b5e-ad3d-d7d9187f4bed/documents/IUC5-fce09a1e-6e33-4e13-be28-4ce879301ce2_dcc2bcba-0bd6-4040-a122-b3569ffe11d5.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Cuprate(4-), [μ-[[7,7'-[[6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]diimino]bis[4-(hydroxy-κO)-3-[[2-(hydroxy-κO)-5-sulfophenyl]azo-κN1]-2-naphthalenesulfonato]](8-)]]di-, tetrasodium",129874-15-3, The NOAEL of Everdirect SH12 >1000 mg/kg B.W. (OECD TG407). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c2a7adc-1110-467a-8de9-5982863c6d11/documents/3b53f975-495c-4a0b-83a7-003e9d001f2f_18d83a76-1e48-4591-ad17-c08ba5212330.html,,,,,, "Cuprate(4-), [μ-[[7,7'-[[6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]diimino]bis[4-(hydroxy-κO)-3-[[2-(hydroxy-κO)-5-sulfophenyl]azo-κN1]-2-naphthalenesulfonato]](8-)]]di-, tetrasodium",129874-15-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c2a7adc-1110-467a-8de9-5982863c6d11/documents/3b53f975-495c-4a0b-83a7-003e9d001f2f_18d83a76-1e48-4591-ad17-c08ba5212330.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Cuprate(4-), [μ-[[7,7'-[[6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]diimino]bis[4-(hydroxy-κO)-3-[[2-(hydroxy-κO)-5-sulfophenyl]azo-κN1]-2-naphthalenesulfonato]](8-)]]di-, tetrasodium",129874-15-3, Acute toxicity: via oral route The LD50 of the test material was greater than 2000 mg/kg B.W. (OECD TG401). Acute toxicity: via dermal route The LD50 of Everdirect SH12 was greater than 2000 mg/kg B.W. (OECD TG402). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c2a7adc-1110-467a-8de9-5982863c6d11/documents/de66902c-61dc-4cb3-8cb1-22444b572bbf_18d83a76-1e48-4591-ad17-c08ba5212330.html,,,,,, "Cuprate(4-), [μ-[[7,7'-[[6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]diimino]bis[4-(hydroxy-κO)-3-[[2-(hydroxy-κO)-5-sulfophenyl]azo-κN1]-2-naphthalenesulfonato]](8-)]]di-, tetrasodium",129874-15-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c2a7adc-1110-467a-8de9-5982863c6d11/documents/de66902c-61dc-4cb3-8cb1-22444b572bbf_18d83a76-1e48-4591-ad17-c08ba5212330.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Cuprate(4-), [μ-[[7,7'-[[6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]diimino]bis[4-(hydroxy-κO)-3-[[2-(hydroxy-κO)-5-sulfophenyl]azo-κN1]-2-naphthalenesulfonato]](8-)]]di-, tetrasodium",129874-15-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c2a7adc-1110-467a-8de9-5982863c6d11/documents/de66902c-61dc-4cb3-8cb1-22444b572bbf_18d83a76-1e48-4591-ad17-c08ba5212330.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Cuprate(6-), [2-[[[[3-[[4-chloro-6-[[4-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,5-disulfophenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulfophenyl]azo]phenylmethyl]azo]-5-sulfobenzoato(8-)]-, pentasodium hydrogen, (SP-4-3)-",68132-91-2,"The only test-item related effects seen in this study were reversible blue discolouration of several organs and tissues. Hence, the NOAEL (No Observed Adverse Effect Level) was considered to be 1000 mg/kg body weight/day for male and female rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b85517a-70f6-47ee-8bb0-d4e15b1a000f/documents/8714afcf-9b54-48c8-8c6c-7b54cf134835_2d1ce771-1724-439f-b21c-1b2b5d6604b9.html,,,,,, "Cuprate(6-), [2-[[[[3-[[4-chloro-6-[[4-[[4-chloro-6-[(3-sulfophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,5-disulfophenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulfophenyl]azo]phenylmethyl]azo]-5-sulfobenzoato(8-)]-, pentasodium hydrogen, (SP-4-3)-",68132-91-2, No signs of acute toxicity (oral) in male and female rats were observed. The LD50 was determined > 4000 mg/kg bw based on test material. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b85517a-70f6-47ee-8bb0-d4e15b1a000f/documents/c76ac5b2-bca0-423b-81a0-6fab8ff1c0e1_2d1ce771-1724-439f-b21c-1b2b5d6604b9.html,,,,,, Cyanoacetic acid,372-09-8,ORAL No adverse effects were observed in an invalid 7-week drinking water study with rats. A NOAEL was not established. DERMAL and INHALATION No data are available. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f05c47c5-2070-44e1-b064-0a87a13ab51d/documents/IUC5-41e9b211-b694-4af6-b400-06c85f329462_d16a020f-e976-4e03-a387-94287e430419.html,,,,,, Cyanoacetic acid,372-09-8,"ORAL Oral LD50 Combined = 1010 mg/kg bw (95% C.I. 831 - 1228). Cyanoacetic acid is of SLIGHT Toxicity based on the LD50 in males and females(OECD GHS Toxicity Category IV).DERMAL Dermal LD50 Combined > 2000 mg/kg bw (no mortality occurred, limit test). Cyanoacetic acid is of LOW Toxicity based on an LD50 exceeding 2000 mg/kg bw. INHALATION LC50 Males = 1.4 mg/L. LC50 Females = 2.6 mg/L. LC50 Combined = 1.9 mg/L. Cyanoacetic acid is of SLIGHT Toxicity based on the LD50 in males (OECD GHS Toxicity Category IV). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f05c47c5-2070-44e1-b064-0a87a13ab51d/documents/IUC5-271489c7-574d-4962-b16f-510806a7b2af_d16a020f-e976-4e03-a387-94287e430419.html,,,,,, Cyanoacetic acid,372-09-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f05c47c5-2070-44e1-b064-0a87a13ab51d/documents/IUC5-271489c7-574d-4962-b16f-510806a7b2af_d16a020f-e976-4e03-a387-94287e430419.html,,oral,LD50,"1,010 mg/kg bw",, Cyanoacetic acid,372-09-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f05c47c5-2070-44e1-b064-0a87a13ab51d/documents/IUC5-271489c7-574d-4962-b16f-510806a7b2af_d16a020f-e976-4e03-a387-94287e430419.html,,dermal,LD50,"2,000 mg/kg bw",, Cyanoacetic acid,372-09-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f05c47c5-2070-44e1-b064-0a87a13ab51d/documents/IUC5-271489c7-574d-4962-b16f-510806a7b2af_d16a020f-e976-4e03-a387-94287e430419.html,,inhalation,LC50,0.002 mg/m3,, Cyanogen chloride,506-77-4," Despite the extremely poor information in the literature available, it should be assumed that the absorptive-toxic potential of cyanogen chloride will be little different from that of hydrogen cyanide. Animal data Chronic Exposure or Carcinogenicity (EPA's Oral RfD) for chlorine cyanide is based in part on a chronic toxicity study in rats conducted by Howard and Hanzal in 1955. In this 2 -year dietary study, rats (10/sex/group) were administered food fumigated with hydrogen cyanide. The average daily concentrations were 73 and 183 mg CN/kg diet. From the data reported on food consumption and body weight, daily estimated doses were 4.3 mg and 10.8 mg CN/kg bw. The average food CN concentrations were estimated based on the authors' data for concentration at the beginning and end of each food preparation period and by assuming a first-order rate of loss for the intervening period. There were no treatment-related effects on growth rate, no gross signs of toxicity, and no histopathological lesions [1]. Human data Ten workers inhalatively exposed to non-quantified chlorocyan doses for long time periods suffered from muscular weakness, weariness, nausea, vomiting, diarrhoea, urge to urinate, cough, irritation to the skin, chronic headache, feeling of cold and loss of weight. An increased incidence of conjunctivitis and eyelid edema was registered. In a subacute inhalative experiment on dogs exposed to sublethal concentrations (no details given) daily for between 30 min and 2 hours, the following symptoms were reported: severe irritation to the eyes and upper airways, cramps, increased respiratory and heart frequency, vomiting, diarrhoea and severe weight loss. The pathological anatomical examination carried out later revealed congestion in the lung [2]. There is also distinct irritative action to the mucous membranes even at low concentrations. Due to the age of the study and the methodology used, the test was considered to be not reliable and therefore inappropriate for classification and labelling. References: [1] U.S. Environmental Protection Agency's Integrated Risk Information System (IRIS) on Chlorine Cyanide (506-77-4). [2] DFG: Toxikologisch-arbeitsmedizinische Begründungen von MAK-Werten; Verlag Chemie ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e67b522-afe0-46c2-b178-1771498f09d0/documents/5b46e5ca-cba1-4571-9c3d-bcc878fabf5a_e4e5daa1-74a3-40e5-8dd1-61ee76e71cca.html,,,,,, Cyanogen chloride,506-77-4," Summary: There is only limited information (animal and human data) on the acute toxicity of ClCN available. The available results listed below can be used as rough basis for the assessment. In the absence of further animal data, it can be assumed that chlorcyan has a similar toxicity as hydrogen cyanide. The main intake pathway for cyanogen chloride proceeds via the respiratory tract. Chlorcyan is moderately soluble in water (25 cm3 of the gas/ml water at 20 degrees C) and hydrolyzed to form cyanic acid and hydrochloric acid. Because systemic effects have occurred after exposure of both humans and also in animal experiments and these effects are similar to a poisoning with HCN, absorption of the intact noxa, which has been deposited on the mucous membranes of the respiratory tract, is to be presumed. No data is available on the penetration of the gas through the intact skin. Because symptoms of irritation to the skin were registered following chronic exposure of workers (see ""Chronic toxicity""), it can be concluded that the substance reacts with corresponding constituents of the skin. During this, HCN can be released which is effectively absorbed through the skin. Until information to the contrary is available, skin, absorption should therefore be assumed. Under conditions encountered in practice, intake by the gastrointestinal pathway is not relevant. Main toxic effects Acute: Severe irritation to the eyes and airways, lung damage, neurotoxic effects, gastrointestinal complaints. Although the toxicological database for chlorcyan is small, it allows the conclusion to be drawn that the noxa (partially used as a constituent of poison gas in World Wars I/II) combines a very severe potential to irritate and to cause systemic effects. Concentrations > 20 ppm irritate the eyes, 40 ppm causes blepharospasm and intense lacrimation [2]. Skin: Neither experience nor animal experiments are available on acute skin irritation through contact with the gas. Therefore, it is also impossible to assess the dermal toxicity. However, this would be important in order to assess the risk which would exist in an accidental situation when a highly contaminated area were entered with an escape mask only. To be on the safe side, a high dermal toxicity should be expected. Inhalation: For inhalative exposure, 20 ppm was reported to be the concentration limit which can be tolerated by humans for the maximum of 1 minute [1]. The pungent odor is already perceptible from 1 ppm upwards. [3]. Because at this concentration massive tissue damage or systemic effects are not to be expected in cases of short-term exposure, the substance was added to the infamous ""Zyklon B"" as a warning substance (and as a polymerization inhibitor). 40 ppm chlorcyan in the air one breathes leads to severe irritation to the eyes (see above), sight defects and tussive irritation. High exposures (no details given) additionally caused dizziness and nausea. In older experiments on various animal species, the period of time was detected in which certain concentrations cause death. At 100 ppm, 20 and 37 minutes were required for dogs and rats, respectively, at 340 ppm these periods lay below 10 minutes. Poisoning symptoms resulted from a combination of toxic pulmonary edema and disturbances to the cellular respiration due to the cyano group. This diagnosis was supported by the fact that only 8 % of dogs survived when they were exposed to 920 - 1440 ppm for 1 - 2 minutes. By comparison, when amyl nitrite (antidote against cyanide) and oxygen were applied after this exposure, 77 % of the animals survived. Dogs recovered after inhaling 0.05 mg/L (20 ppm) for 20 min. Those inhaling 0.3 mg/L (120 ppm) for 8 min exhibited severe injury but they recovered [1]. In mice, inhalation of 0.2 mg/L (80 ppm) cyanogen chloride for 5 min was tolerated by some animals; 0.3 mg/L (120 ppm) for 3.5 min was fatal to some animals. [5]. Cyanogen chloride has caused marked irritation of the respiratory tract with hemorrhagic exudate from the bronchi and trachea, and pulmonary edema. A concentration of approximately 500 ppm (1.0 mg/L) for 3 minutes was fatal to the mouse; 120 ppm (0.3 mg/L) for 3.5 minutes was fatal to the cat; 48 ppm (0.12 mg/L) for 6 hours was fatal for a dog; a goat exposed at 1000 ppm (2.5 mg/L) for 3 minutes died after 70 hours; and a concentration of 1200 ppm (3.0 mg/L) was fatal to the rabbit. Results [4]: - LC50 rat, inhal = 5400 mg/m3 (3 min) - LC50 mouse, inhal = 3000 mg/m3 (0.5 min) - LC50 rabbit, inhal = 6000 mg/m3 (7 min) - LC50 guinea pigs, inhal = 5500 mg/m3 (2 min) - LC50 cat, inhal = 6000 mg/m3 (1 min) - LC50 cat, oral = 6000 mg/m3 - LC50 dog, inhal = 3800 mg/m3 (1 min) References: [1] DFG: Toxikologisch-arbeitsmedizinische Begründungen von MAK-Werten; Verlag Chemie] [2] W.M. Grant, J.S. Schuman: Toxicology of the eyes; 4th Edition, Charles C Thomas Publisher, Springfield, Illinois; 1993 [3] American Conference of Governmental Industrial Hygienists ""Documentation of the threshold limit values and biological exposure indices (2006) [4] Lewis, R.J. Sr. (ed) Sax's Dangerous Properties of Industrial Materials. 11th Edition. Wiley-Interscience, Wiley & Sons, Inc. Hoboken, NJ. 2004., p. 1022-1023 [5] Bingham, E.; Cohrssen, B.; Powell, C.H.; Patty's Toxicology Volumes 1-9 5th ed. John Wiley & Sons. New York, N.Y. (2001)., p. 4:1397 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e67b522-afe0-46c2-b178-1771498f09d0/documents/IUC5-aaf13cc4-5043-42a9-b8e1-74f46c5a0bdd_e4e5daa1-74a3-40e5-8dd1-61ee76e71cca.html,,,,,, Cyanoguanidine,461-58-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af0021a3-2602-482c-a088-90f341844c08/documents/IUC5-d17c902a-f628-46b5-9c65-a5778d2bde66_bbefe9c7-2905-4e93-8795-2d09977ce8f8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,291 mg/kg bw/day",,rat Cyanoguanidine,461-58-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af0021a3-2602-482c-a088-90f341844c08/documents/IUC5-90d2e6aa-7be2-4999-aac5-6c970c63dcc4_bbefe9c7-2905-4e93-8795-2d09977ce8f8.html,,inhalation,LC50,259 mg/m3,no adverse effect observed, Cyanuric acid,108-80-5," Repeat dose studies by the oral route have been conducted ( 59 day, 13 week (according to OECD guideline 408) and 104 weeks (according to EU Method B.33)  on cyanuric acid or sodium cyanurate monohydrate. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5fad27dd-03bf-4692-9ae5-6f2a39734ad0/documents/IUC5-530f8954-1733-460d-8383-7b0944fb2688_9b2e355b-04d0-4182-b293-498585c3a2b0.html,,,,,, Cyanuric acid,108-80-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5fad27dd-03bf-4692-9ae5-6f2a39734ad0/documents/IUC5-530f8954-1733-460d-8383-7b0944fb2688_9b2e355b-04d0-4182-b293-498585c3a2b0.html,Chronic toxicity – systemic effects,oral,NOAEL,154 mg/kg bw/day,,rat Cyanuric acid,108-80-5," Acute oral, dermal and inhalation studies have been performed with cyanuric acid. Experimental data showed no evidence of acute toxicity to cyanuric acid. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fad27dd-03bf-4692-9ae5-6f2a39734ad0/documents/IUC5-588f451d-a949-4aa7-8b62-12301f7b0d44_9b2e355b-04d0-4182-b293-498585c3a2b0.html,,,,,, Cyanuric acid,108-80-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fad27dd-03bf-4692-9ae5-6f2a39734ad0/documents/IUC5-588f451d-a949-4aa7-8b62-12301f7b0d44_9b2e355b-04d0-4182-b293-498585c3a2b0.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Cyanuric acid,108-80-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fad27dd-03bf-4692-9ae5-6f2a39734ad0/documents/IUC5-588f451d-a949-4aa7-8b62-12301f7b0d44_9b2e355b-04d0-4182-b293-498585c3a2b0.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Cyanuric acid,108-80-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fad27dd-03bf-4692-9ae5-6f2a39734ad0/documents/IUC5-588f451d-a949-4aa7-8b62-12301f7b0d44_9b2e355b-04d0-4182-b293-498585c3a2b0.html,,inhalation,LC50,"5,250 mg/m3",no adverse effect observed, "Cyclododeca-1,5,9-triene",4904-61-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d922ccf-2ebd-4aa3-a4ba-f7f176a3d497/documents/16d9299a-a04e-487c-991c-7d52044757cb_ea9233b4-5f99-4a49-b190-097b889b4aa0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "Cyclododeca-1,5,9-triene",4904-61-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d922ccf-2ebd-4aa3-a4ba-f7f176a3d497/documents/16d9299a-a04e-487c-991c-7d52044757cb_ea9233b4-5f99-4a49-b190-097b889b4aa0.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,33.4 mg/m3,,rat "Cyclododeca-1,5,9-triene",4904-61-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d922ccf-2ebd-4aa3-a4ba-f7f176a3d497/documents/16d9299a-a04e-487c-991c-7d52044757cb_ea9233b4-5f99-4a49-b190-097b889b4aa0.html,Repeated dose toxicity – local effects,inhalation,NOAEC,334 mg/m3,adverse effect observed,rat "Cyclododeca-1,5,9-triene",4904-61-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d922ccf-2ebd-4aa3-a4ba-f7f176a3d497/documents/9427e1f9-d162-48cf-bd9a-db3eed7c3874_ea9233b4-5f99-4a49-b190-097b889b4aa0.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, "Cyclododeca-1,5,9-triene",4904-61-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d922ccf-2ebd-4aa3-a4ba-f7f176a3d497/documents/9427e1f9-d162-48cf-bd9a-db3eed7c3874_ea9233b4-5f99-4a49-b190-097b889b4aa0.html,,dermal,discriminating dose,"3,520 mg/kg bw",no adverse effect observed, "Cyclododeca-1,5,9-triene",4904-61-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d922ccf-2ebd-4aa3-a4ba-f7f176a3d497/documents/9427e1f9-d162-48cf-bd9a-db3eed7c3874_ea9233b4-5f99-4a49-b190-097b889b4aa0.html,,inhalation,LC50,"8,200 mg/m3",adverse effect observed, Cyclododecane,294-62-2,"A preliminary 2-week acute oral repeated dose toxicity study was performed in order to select dose levels for a oral 28 day repeated dose toxicity study and to provide preliminary information on the potential toxicity of the test substance. The daily administration to rats over 2 weeks at 0, 50, 250, 1000 or 2000 mg/kg/day induced ptyalism at 250, 1000 and 2000 mg/kg/day, soiled urogenital area at 2000 mg/kg/day (females) an an increase in liver weights was observed at 1000 and 2000 mg/kg/day (CIT 1994). In a 28-day repeated dose oral toxicity study three groups of male and female rats were dosed with 50, 150, and 500 mg (except first day 1000mg/kg) test substance daily for 4 weeks by oral gavage (CIT 1994). A concurrrent control group received olive oil only. The daily administration of test substance induced mortalities and poor clinical conditions in females after one treatment at 1000 mg/kg/day, ptyalism at all dose levels and a slight increase in food consumption in females given 1000/500 mg/kg/day. A decrease in glucose level was noted at 1000/500 mg/kg/day and granular casts were found in the urine of males at all dose levels. In addition, an increase in liver weight, correlated to hepatocellular hypertrophy was noted in femals given 1000/500 mg/kg/day. An increase in kidney weights correlated to irregular colour and presence of acidophilic globules (due to the presence of alpha 2 µ globulin) in the cortical tubular epithelium was found in males at all dose levels, and were considered to be of no toxicological significance, in regard to the specificity of this urinary protein in the male rat. For all these findings, evidence of reversibility was found after two weeks without treatment. Therefore, under this experimental conditions, the No Observe Adverse Effect level is 150 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48fb0c95-bec2-454d-bc38-2d3bde522825/documents/52d3f25c-9024-43af-8c39-ef4a04937738_40cc91bb-88f0-4232-9284-1490cbdfbe2e.html,,,,,, Cyclododecane,294-62-2,"Three acute toxicity tests  in rats and mouse were available (Hüls AG 1984, Bayer 1964, Bayer 1964). In the key study from Hüls (1984) the test item Cyclododecane was applied two times, separated by 2 hours, to 5 male and 5 female Wistar rats in dose of 10.000 mg/kg bw, volume of administration was 20 ml/kg. The observation period was 14 days. Two female rats died within 7 hours after oral application of the test item. Pale mucosa of stomach and gastro-intestinal tract, bright discoloration of kidney and spleen, dark spots and small blood vessels on the liver were observed in animals that  died during the study. 1/2 - 2 hours post application, animals revealed  pilo-erection and diuresis, later accompanied by tremor,  convulsions,  diarrhoea, blood from eyes and noses, lying on back, side, or in prone  position, sounds in case of contact,  Straub reaction and walking on toes.  Symptoms of toxicity were visible for up to 72 hours. Under the conditions of this study the acute toxicity of Cyclododecane after oral application in rats is very low. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48fb0c95-bec2-454d-bc38-2d3bde522825/documents/4a99ba27-0e4b-4a1e-9c40-f8094c58c687_40cc91bb-88f0-4232-9284-1490cbdfbe2e.html,,,,,, Cyclododecanone,830-13-7,Two oral acute toxicity test were conducted with the test substance in rats and mice (Bayer 1964). The LD50 is greater than 2500 mg/kg bw. Based on the results of the study the substance showed low acute oral toxicity in rats and mice.   ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27533156-7b5b-4f44-bc57-e15ade9738a7/documents/dbb5f0bd-5026-48fa-8ce8-e4ef0e46bbcc_719f9c5d-b91d-49ee-b0a3-1e35a7a46df7.html,,,,,, "Cyclohex-1,2-ylenediamine",694-83-7,"DCH (DYTEK DCH-99) was applied to male and female Han Wistar rats via gavage (vehicle water, pH adjusted formulation) at doses of 0, 50, 150 or 500 mg/kg bw/day according to OECD TG 408 (daily exposure for 13 weeks). In view of the various effects seen at the high and mid dose groups tested, the no-observed-adverse-effect level (NOAEL) in this oral gavage study was 50 mg/kg bw/day for males and 150 mg/kg bw/day for females. In a subacute inhalation toxicity study male rats were exposed for 6 hours per day and overall 10 times within two weeks to an aerosol/vapour mixture of DCH. Concentrations used were 0, 10, 49 and 240 mg/m³ (analytical). Local effects on the upper respiratory tract were observed in each dose group. Therefore, a LOAEC of 10 mg/m³ was established and classification with respect to specific target organ toxicity after short-term exposure is proposed: (STOT SE Cat 3, H335, together with Corr. Cat 1A). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): One reliable subacute study for the submission substance (Klimisch score = 2) is available. Overall the quality of the database is good. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): One reliable subchronic study for the submission substance (Klimisch score = 1) is available. One further subacute study is at hand ( Klimisch score = 1). Overall the quality of the database is high. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6663683-03cd-43b8-a605-4f141e3b0b42/documents/1dcfe7c1-6473-4622-86b8-e69b8a6c0b09_0e4f54b5-6a6b-4a76-849d-d6b3c69aa50a.html,,,,,, "Cyclohex-1,2-ylenediamine",694-83-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6663683-03cd-43b8-a605-4f141e3b0b42/documents/1dcfe7c1-6473-4622-86b8-e69b8a6c0b09_0e4f54b5-6a6b-4a76-849d-d6b3c69aa50a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Cyclohex-1,2-ylenediamine",694-83-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6663683-03cd-43b8-a605-4f141e3b0b42/documents/1dcfe7c1-6473-4622-86b8-e69b8a6c0b09_0e4f54b5-6a6b-4a76-849d-d6b3c69aa50a.html,Repeated dose toxicity – local effects,inhalation,LOAEC,10 mg/m3,adverse effect observed,rat "Cyclohex-1,2-ylenediamine",694-83-7,"Oral In 2 studies similar to OECD guideline 401, DCH was administered via oral gavage to male and female rats. The LD 50 value was calculated to be 1170 mg/kg bw in the one and 2200 mg/kg bw in the other study.    Inhalation: In another study (similar to OECD Tg 403) five groups of either 10 or 6 male Crl:CD*BR rats were exposed, nose-only, to atmospheres of DCH with different purities for a single 4-hour period. Mixed aerosol/vapour test atmospheres were generated by vaporising the liquid and were characterised by gas chromatography and particle size analysis. Mean total DCH concentration ranged from 3.09 to 4.73 mg/L in the 5 separate experiments. Under the conditions of this test, no 4-hour median lethal dose could be determined. A LClo was found to be 3.2 mg/l using 98% pure DCH as test material.   Dermal In a study similar to OECD guideline 402, DCH was administered under occlusive conditions for 24 h to the skin of 5 male and 5 female Sprague-Dawley rats per dose group. The LD 50 value was calculated to be to be 1870 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is reliable (Klimisch 1). The quality of the datbase is therefore high. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The study is reliable (Klimisch 2). The quality of the datbase is therefore good. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study is reliable (Klimisch 1). The quality of the datbase is therefore high. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6663683-03cd-43b8-a605-4f141e3b0b42/documents/113bf460-03a6-4f3f-a8ec-ee076a5a6f5f_0e4f54b5-6a6b-4a76-849d-d6b3c69aa50a.html,,,,,, "Cyclohex-1,2-ylenediamine",694-83-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6663683-03cd-43b8-a605-4f141e3b0b42/documents/113bf460-03a6-4f3f-a8ec-ee076a5a6f5f_0e4f54b5-6a6b-4a76-849d-d6b3c69aa50a.html,,oral,LD50,"1,170 mg/kg bw",adverse effect observed, "Cyclohex-1,2-ylenediamine",694-83-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6663683-03cd-43b8-a605-4f141e3b0b42/documents/113bf460-03a6-4f3f-a8ec-ee076a5a6f5f_0e4f54b5-6a6b-4a76-849d-d6b3c69aa50a.html,,dermal,LD50,"1,870 mg/kg bw",adverse effect observed, "Cyclohex-1,2-ylenediamine",694-83-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6663683-03cd-43b8-a605-4f141e3b0b42/documents/113bf460-03a6-4f3f-a8ec-ee076a5a6f5f_0e4f54b5-6a6b-4a76-849d-d6b3c69aa50a.html,,inhalation,discriminating conc.,3.2 mg/L,adverse effect observed, cyclohexadecanone,2550-52-9," Oral (OECD 407), rat: NOAEL ≥ 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/abcc316e-6549-46ad-b2bb-5d13c040bd03/documents/1d21f0af-4791-4b3f-bd88-247e27df2cde_a02cbb7a-d438-4ea4-b47a-43ae8b191529.html,,,,,, cyclohexadecanone,2550-52-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/abcc316e-6549-46ad-b2bb-5d13c040bd03/documents/1d21f0af-4791-4b3f-bd88-247e27df2cde_a02cbb7a-d438-4ea4-b47a-43ae8b191529.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat cyclohexadecanone,2550-52-9," Oral (OECD 423), rat: LD50: > 2000 mg/kg bw (limit test) Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw (limit test) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abcc316e-6549-46ad-b2bb-5d13c040bd03/documents/77698676-fda4-4897-b5ed-07849b4d63ac_a02cbb7a-d438-4ea4-b47a-43ae8b191529.html,,,,,, "N,N'-(methylenebis(cyclohexane-1,4-diyl))bis(2,2-dimethyl-3-morpholinopropan-1-imine)",2522560-40-1,"In an acute oral toxicity study according to OECD guideline 423, the LD50 was greater than 2000 mg/kg bw (LD50 ≥ 2000 mg/kg bw). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable without restrictions ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f060607e-689c-4abe-b4e6-1bad2c545b08/documents/8c5754e5-a6ff-402b-8e59-96c0843e186f_f7075e64-b709-41c1-8cad-952260a443a3.html,,,,,, "N,N'-(methylenebis(cyclohexane-1,4-diyl))bis(2,2-dimethyl-3-morpholinopropan-1-imine)",2522560-40-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f060607e-689c-4abe-b4e6-1bad2c545b08/documents/8c5754e5-a6ff-402b-8e59-96c0843e186f_f7075e64-b709-41c1-8cad-952260a443a3.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "3,3’,5,5’-tetramethyl-4,4’-diaminodicyclohexylmethane",65962-45-0,Effects on target organs: - heart muscle toxicity observed at 50 mg/kg bw in rats (DRF study prior to OECD 422)- mortality observed at 150 mg/kg bw in rats (DRF study prior to OECD 422) ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/dec63e73-256d-43ef-b241-3e266e02fac3/documents/IUC5-0478eb50-b81d-4509-b04e-d080225c80fc_ff52c5f1-7d56-4fc4-a076-638d16fce3aa.html,,,,,, "3,3’,5,5’-tetramethyl-4,4’-diaminodicyclohexylmethane",65962-45-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/dec63e73-256d-43ef-b241-3e266e02fac3/documents/IUC5-0478eb50-b81d-4509-b04e-d080225c80fc_ff52c5f1-7d56-4fc4-a076-638d16fce3aa.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,50 mg/kg bw/day,,rat "3,3’,5,5’-tetramethyl-4,4’-diaminodicyclohexylmethane",65962-45-0,"oral: 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane after oral administration was found to be >300 mg/kg bw and <2000 mg/kg bw in rats.dermal: 4,4'-Diamino-3,3',5,5'-tetramethyl-dicyclohexylmethane after dermal application was found to be greater than 2000 mg/kg bw in male and female rats. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dec63e73-256d-43ef-b241-3e266e02fac3/documents/IUC5-1c7f3c64-3e71-48c7-9b2e-7a2c7b20ecc5_ff52c5f1-7d56-4fc4-a076-638d16fce3aa.html,,,,,, "4,4'-methylenebis(N-sec-butylcyclohexamine)",154279-60-4,NH-2 (trade name Clearlink 1000) caused vacuolative changes in various organs of rats at 10 mg/kg/day dose level in a 28-day repeated dose study by Keiji Shiraishi et al. (2002). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/652b3afe-73ec-403a-a10d-0592f64c9c16/documents/a4d14a59-5b9e-494d-9011-812580afc03b_f45ebf6f-874d-4490-b235-a894dda8061c.html,,,,,, "4,4'-methylenebis(N-sec-butylcyclohexamine)",154279-60-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/652b3afe-73ec-403a-a10d-0592f64c9c16/documents/a4d14a59-5b9e-494d-9011-812580afc03b_f45ebf6f-874d-4490-b235-a894dda8061c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "4,4'-methylenebis(N-sec-butylcyclohexamine)",154279-60-4,"In acute toxicity studies local irritation/corrosion is the main effect.The LD50 value for undiluted test substance (Clearlink 1000) was 227 mg/kg bw for males.In acute dermal studies the LD50 value was greater than 1600 mg/kg bw, but less than 2000 mg/kg bw. No valid data are available on acute inhalation toxicity. Clearlink 1000 has corrosive properties and no testing is required. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/652b3afe-73ec-403a-a10d-0592f64c9c16/documents/6d1ece06-f013-40a9-b97a-1370eb78753e_f45ebf6f-874d-4490-b235-a894dda8061c.html,,,,,, "4,4'-methylenebis(N-sec-butylcyclohexamine)",154279-60-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/652b3afe-73ec-403a-a10d-0592f64c9c16/documents/6d1ece06-f013-40a9-b97a-1370eb78753e_f45ebf6f-874d-4490-b235-a894dda8061c.html,,oral,LD50,227 mg/kg bw,, "4,4'-methylenebis(N-sec-butylcyclohexamine)",154279-60-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/652b3afe-73ec-403a-a10d-0592f64c9c16/documents/6d1ece06-f013-40a9-b97a-1370eb78753e_f45ebf6f-874d-4490-b235-a894dda8061c.html,,dermal,discriminating dose,"1,600 mg/kg bw",, "N,N,N-trimethyl-cyclohexanaminium hydroxide",19895-48-8, NOAEL 150 mg/kg bw/d (highest dose tested due to corrosive properties of test substance) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9aa42ce7-a10b-4a13-b777-1271243e5f53/documents/ea24bbf5-7b1a-409a-84b8-a2a85f5995f0_6d4e895f-454d-436f-a65a-a8017d0dc8cb.html,,,,,, "N,N,N-trimethyl-cyclohexanaminium hydroxide",19895-48-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9aa42ce7-a10b-4a13-b777-1271243e5f53/documents/ea24bbf5-7b1a-409a-84b8-a2a85f5995f0_6d4e895f-454d-436f-a65a-a8017d0dc8cb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "N,N,N-trimethyl-cyclohexanaminium hydroxide",19895-48-8, acute toxicity testing is not required since the substance is classified as corrosive to skin. LD50(rat) sulfate salt: >600 <2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9aa42ce7-a10b-4a13-b777-1271243e5f53/documents/IUC5-dfee3c75-a99f-4d32-bb5f-f8ba4e999103_6d4e895f-454d-436f-a65a-a8017d0dc8cb.html,,,,,, "N,N,N-trimethyl-cyclohexammonium sulfate",1004297-30-6,"LD50(rat): 600 - 2000 mg/kg bw for trimethylcyclohexyl ammonium sulfate, aqueous solution 50 wt.% ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ad71f6f-231d-463f-b68e-b87d783e95ae/documents/IUC5-83d6eb1b-0458-4a04-ad1a-1874e6a7fdce_8b822e03-3bae-4855-9df4-def05b2a3881.html,,,,,, "Reaction mass of cis-Cyclohexane, 1,4-bis(ethoxymethyl) and trans-Cyclohexane, 1,4-bis(ethoxymethyl)",54889-63-3,"A oral toxicity to reproduction study was conducted according to OECD 415 with extended parameter examinations. The NOAEL for general, systemic toxicity is 5 mg/kg bw/day for the F0 parental rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86165a33-050a-47c6-97c1-0b92aab7bd69/documents/IUC5-d5772d39-1c92-4dcc-8ca3-7b0cf7b3ad59_25d30ac4-61ac-4676-aac2-2a8392ca2454.html,,,,,, "Reaction mass of cis-Cyclohexane, 1,4-bis(ethoxymethyl) and trans-Cyclohexane, 1,4-bis(ethoxymethyl)",54889-63-3,Acute oral toxicity:- OECD 423: LD50 > 2000 mg/kg bwAcute toxicity via inhaltion- OECD 423: LC50 > 5.2 mg/LAcute dermal toxicity- OECD 402: LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86165a33-050a-47c6-97c1-0b92aab7bd69/documents/IUC5-225bb8fd-93a1-49eb-be0f-2f12bb6edf1d_25d30ac4-61ac-4676-aac2-2a8392ca2454.html,,,,,, "Copolymer of acetonoxime and 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate",1001254-87-0," Oral route: There is a 90 day sub-chronic oral toxicity study available. Overall Conclusion: All described observations, although statistically significant, were not considered of any biological or any toxicological significance since no correlating effects were found at the histopathological evaluation in particular in the liver. Moreover, most changes noted had subsided at the end of the 4 -week recovery period. Under the present test conditions of this study, the no observed adverse effect level (NOAEL) was above 1000 mg test item/kg b.w./day. Study was conducted in accordance with ECHA Decision TPE-D-2114306081-68-01/F Helsinki, 30 July 2015 Inhalation route: A subacute 28 day or subchronic 90 day inhalation toxicity study is not needed, because a subchronic oral  90 day toxicity study is available for the substance.  According to ECHA decision TPE-D-2114306081-68-01/F Helsinki, 30 July 2015, ECHA considers that testing by oral route is most appropriate. Cited from the decision:  ""In light of the physicochemical properties of the substance, a solid with a high molecular weight, very low vapour pressure and low water solubility and the information provided on the uses and human exposure (i.e. no uses with spray application), ECHA considers that testing by the oral route is most appropriate."" Dermal route: A 14-day range finding study of cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, acetone oxime-blocked in rats by dermal administration (0, 30, 100 and 1000 mg/kg bw/day; 6 hours/day, 5 days/week; based on OECD 411) did not cause any signs of local or systemic intolerance. None of the rats died prematurely. No test item-related influence was noted on the body weight, food and drinking water consumption. Macroscopic examination at necropsy revealed no test item-related changes at any of the tested groups. Therefore, under the conditions of this study the highest concentration (1000 mg/kg bw /day) is considered to be the No Observed Adverse Effect Level (NOAEL). In addition to No Observed Adverse Effect Level (NOAEL > 1000 mg/kg bw /day) via oral route and the physicochemical properties (described in chapter 4) it can be concluded that further testing by dermal route is not needed. Cited from the decision:  ""In light of the physicochemical properties of the substance, a solid with a high molecular weight, very low vapour pressure and low water solubility and the information provided on the uses and human exposure (i.e. no uses with spray application), ECHA considers that testing by the oral route is most appropriate."" ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec2450c7-5a1f-4918-8ad7-d9c72fc824fa/documents/IUC5-d3f8ef06-0817-48fb-bd9e-2e4ac98f9ad1_91906eaa-9e3e-44d6-957a-838fe0b3cea4.html,,,,,, "Copolymer of acetonoxime and 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate",1001254-87-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec2450c7-5a1f-4918-8ad7-d9c72fc824fa/documents/IUC5-d3f8ef06-0817-48fb-bd9e-2e4ac98f9ad1_91906eaa-9e3e-44d6-957a-838fe0b3cea4.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Copolymer of acetonoxime and 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate",1001254-87-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec2450c7-5a1f-4918-8ad7-d9c72fc824fa/documents/IUC5-d3f8ef06-0817-48fb-bd9e-2e4ac98f9ad1_91906eaa-9e3e-44d6-957a-838fe0b3cea4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Copolymer of acetonoxime and 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate",1001254-87-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec2450c7-5a1f-4918-8ad7-d9c72fc824fa/documents/IUC5-d3f8ef06-0817-48fb-bd9e-2e4ac98f9ad1_91906eaa-9e3e-44d6-957a-838fe0b3cea4.html,Repeated dose toxicity – local effects,dermal,NOAEL,7.4 mg/cm2,no adverse effect observed,rat "Copolymer of acetonoxime and 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate",1001254-87-0,"No acute toxicity tests are available for the inhalation route of exposure. A data waiver is claimed.Cyclohexane, 5-isocyanato-1-(isocyanatomethyl)-1,3,3-trimethyl-, homopolymer, acetone oxime-blocked is of low oral and dermal acute toxicity with an oral LD50 (rat) of > 2000 mg/kg bw (Hüls AG, 1998) and a dermal LD50 (rat) of > 2000 mg/kg bw (LPT, 2012). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec2450c7-5a1f-4918-8ad7-d9c72fc824fa/documents/IUC5-af349245-2848-4419-8343-10c68e1d04af_91906eaa-9e3e-44d6-957a-838fe0b3cea4.html,,,,,, "Copolymer of acetonoxime and 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate",1001254-87-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec2450c7-5a1f-4918-8ad7-d9c72fc824fa/documents/IUC5-af349245-2848-4419-8343-10c68e1d04af_91906eaa-9e3e-44d6-957a-838fe0b3cea4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Copolymer of acetonoxime and 3-isocyanatomethyl-3,5,5-trimethylcyclohexyl isocyanate",1001254-87-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec2450c7-5a1f-4918-8ad7-d9c72fc824fa/documents/IUC5-af349245-2848-4419-8343-10c68e1d04af_91906eaa-9e3e-44d6-957a-838fe0b3cea4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Cyclohexane, oxidized, aq. ext.",68915-38-8,"There are no repeated dose toxicity studies available on Cyclohexane, oxidized, aquous extract (COP Acid), but a well-documented chronic study on the primary component, adipic acid, is considered a reliable read-across.  In this 2-year oral study, adipic acid was of low repeated dose toxicity, however it was not tested according to modern standards. The NOAEL was 1% for male rats (approx. 750 mg/kg bw/day) and higher doses (3 and 5%) caused body weight retardation with no indication of specific target organ toxicity. The NOAEL for female rats was 1% (approx. 750 mg/kg bw/day), the highest dose tested in females. In humans no symptoms were reported after oral administration of up to 7 g adipic acid per day for up to 10 days to 7 volunteers to investigate compound excretion. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/730217f6-8a5d-4da1-8098-d91f25ca501b/documents/IUC5-f200d7b5-96e9-4b17-963a-b5d48c5c508c_e428871d-9730-47f2-8a8f-ab6d67e2e32a.html,,,,,, "Cyclohexane, oxidized, aq. ext.",68915-38-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/730217f6-8a5d-4da1-8098-d91f25ca501b/documents/IUC5-f200d7b5-96e9-4b17-963a-b5d48c5c508c_e428871d-9730-47f2-8a8f-ab6d67e2e32a.html,Chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Cyclohexane, oxidized, aq. ext.",68915-38-8,"COP acid and the read across ingredient, adipic acid, have very low acute toxicity. The oral and dermal LD50 in rats are > 5000 mg/kg bw. In an acute inhalation test  neither mortality nor symptoms were observed during and after 4 hour exposure to 7700 mg/m3 of adipic acid. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/730217f6-8a5d-4da1-8098-d91f25ca501b/documents/IUC5-406dce65-3ebe-4715-9aa1-c2d649a9e4a5_e428871d-9730-47f2-8a8f-ab6d67e2e32a.html,,,,,, "Cyclohexane, oxidized, aq. ext.",68915-38-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/730217f6-8a5d-4da1-8098-d91f25ca501b/documents/IUC5-406dce65-3ebe-4715-9aa1-c2d649a9e4a5_e428871d-9730-47f2-8a8f-ab6d67e2e32a.html,,oral,LD50,"5,560 mg/kg bw",, "Cyclohexane, oxidized, aq. ext.",68915-38-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/730217f6-8a5d-4da1-8098-d91f25ca501b/documents/IUC5-406dce65-3ebe-4715-9aa1-c2d649a9e4a5_e428871d-9730-47f2-8a8f-ab6d67e2e32a.html,,dermal,discriminating dose,"7,940 mg/kg bw",, "Cyclohexane, oxidized, aq. ext.",68915-38-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/730217f6-8a5d-4da1-8098-d91f25ca501b/documents/IUC5-406dce65-3ebe-4715-9aa1-c2d649a9e4a5_e428871d-9730-47f2-8a8f-ab6d67e2e32a.html,,inhalation,discriminating conc.,"7,700 mg/m3",, "Cyclohexane, oxidized, non-acidic by-products, distn. residues",68609-04-1,No mortality in an acute oral limit dose test (OECD guideline 423- acute toxic class method). LD50 > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5719a12-60f0-450b-ac27-9e37c310a208/documents/IUC5-d6476d53-6f7c-4867-8a28-aafb4cac0c4e_f634d322-221e-4dc8-81f0-1b9679143803.html,,,,,, "Cyclohexane, oxidized, non-volatile residue",68411-76-7,"There are no repeated dose toxicity studies available on Cyclohexane, oxidized, non-volatile residue (NVR), but a well-documented chronic study on the primary component, adipic acid, is considered a reliable read-across. In this 2-year oral study, adipic acid was of low repeated dose toxicity, however it was not tested according to modern standards. The NOAEL was 1% for male rats (approx. 750 mg/kg bw/day) and higher doses (3 and 5%) caused body weight retardation with no indication of specific target organ toxicity. The NOAEL for female rats was 1% (approx. 750 mg/kg bw/day), the highest dose tested in females. In humans no symptoms were reported after oral administration of up to 7 g adipic acid per day for up to 10 days to 7 volunteers to investigate compound excretion. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/720fd5ec-dd25-4038-9cc2-d91b86e88f14/documents/IUC5-f447117b-aeca-41fe-ba51-89896a0cd99f_5bedc396-c06e-4d10-a557-00a1a1b8beca.html,,,,,, "Cyclohexane, oxidized, non-volatile residue",68411-76-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/720fd5ec-dd25-4038-9cc2-d91b86e88f14/documents/IUC5-f447117b-aeca-41fe-ba51-89896a0cd99f_5bedc396-c06e-4d10-a557-00a1a1b8beca.html,Chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Cyclohexane, oxidized, non-volatile residue",68411-76-7,"NVR (Cyclohexane oxidized, non-volatile residue) and the read across ingredient, adipic acid, have very low acute toxicity. The oral and dermal LD50 in rats are > 5000 mg/kg bw. In an acute inhalation test neither mortality nor symptoms were observed during and after 4 hour exposure to 7700 mg/m3 of adipic acid. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/720fd5ec-dd25-4038-9cc2-d91b86e88f14/documents/IUC5-8ba8f997-18b6-4a90-890d-4f8fce88e5a9_5bedc396-c06e-4d10-a557-00a1a1b8beca.html,,,,,, "Cyclohexane, oxidized, non-volatile residue",68411-76-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/720fd5ec-dd25-4038-9cc2-d91b86e88f14/documents/IUC5-8ba8f997-18b6-4a90-890d-4f8fce88e5a9_5bedc396-c06e-4d10-a557-00a1a1b8beca.html,,oral,LD50,"5,000 mg/kg bw",, "Cyclohexane, oxidized, non-volatile residue",68411-76-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/720fd5ec-dd25-4038-9cc2-d91b86e88f14/documents/IUC5-8ba8f997-18b6-4a90-890d-4f8fce88e5a9_5bedc396-c06e-4d10-a557-00a1a1b8beca.html,,dermal,discriminating dose,"7,940 mg/kg bw",, "Cyclohexane, oxidized, non-volatile residue",68411-76-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/720fd5ec-dd25-4038-9cc2-d91b86e88f14/documents/IUC5-8ba8f997-18b6-4a90-890d-4f8fce88e5a9_5bedc396-c06e-4d10-a557-00a1a1b8beca.html,,inhalation,discriminating conc.,"7,700 mg/m3",, "Cyclohexane-1,2,4-triyltris(ethylene)",2855-27-8, There is no experimental data available on repeated dose toxicity of TVCH. The standard information requirement is waived because relevant human exposure can be excluded. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/adf31dc4-5229-4ed7-8061-47ad06976c36/documents/2a0f9023-5d49-42d0-ab10-02e8a30a4746_ba84c5b0-c2b9-4640-9094-41fae99fdf16.html,,,,,, "Cyclohexane-1,2,4-triyltris(ethylene)",2855-27-8," In an acute oral dose study in male and female rats with TVCH, 2 out of 10 or 3 out of 10 animals died following administration of 3980 or 5010 mg/kg, respectively. The following clincial signs were observed beginning 30 to 60 minutes after administration: piloerection, hunched posture, diarrhea, diuresis, unsteady gait, increased drinking water consumption, ataxia, tremor, sedation, clonic convulsions, lateral and prone position. After 7 days all observations have been subsided. Acute toxicity studies by the inhalation and dermal routes of exposure have been waived because of exposure considerations and available information. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/adf31dc4-5229-4ed7-8061-47ad06976c36/documents/19f1a273-1f44-407d-92cc-466354a67737_ba84c5b0-c2b9-4640-9094-41fae99fdf16.html,,,,,, "Cyclohexane-1,2-dicarboxylic anhydride",85-42-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e763b68-a52e-49c7-9e35-e9c9b2ef4b23/documents/IUC5-be37a3d1-3eb9-41d2-9e87-de4b2f4f9eb4_7a9a819a-0095-49d6-92ab-2843c89ec386.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Cyclohexane-1,2-dicarboxylic anhydride",85-42-7,Acute toxicity:Oral - LD50 - 4040 mg/kgInhalation: LD50 - > 1100 mg/m3Dermal: LD50 - > 2000 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e763b68-a52e-49c7-9e35-e9c9b2ef4b23/documents/IUC5-d72a787f-2e08-4b15-a8b1-451c906f1e3f_7a9a819a-0095-49d6-92ab-2843c89ec386.html,,,,,, "Cyclohexane-1,2-dicarboxylic anhydride",85-42-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e763b68-a52e-49c7-9e35-e9c9b2ef4b23/documents/IUC5-d72a787f-2e08-4b15-a8b1-451c906f1e3f_7a9a819a-0095-49d6-92ab-2843c89ec386.html,,oral,LD50,"4,040 mg/kg bw",adverse effect observed, "Cyclohexane-1,2-dicarboxylic anhydride",85-42-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e763b68-a52e-49c7-9e35-e9c9b2ef4b23/documents/IUC5-d72a787f-2e08-4b15-a8b1-451c906f1e3f_7a9a819a-0095-49d6-92ab-2843c89ec386.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Cyclohexane-1,2-dicarboxylic anhydride",85-42-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e763b68-a52e-49c7-9e35-e9c9b2ef4b23/documents/IUC5-d72a787f-2e08-4b15-a8b1-451c906f1e3f_7a9a819a-0095-49d6-92ab-2843c89ec386.html,,inhalation,LC50,"1,100 mg/m3",no adverse effect observed, "methyl cis-1-{[(2,5-dimethylphenyl)acetyl]amino}-4-methoxycyclohexanecarboxylate",203313-47-7,"Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71af1f6e-bead-48ea-a7c4-6e8213734b8d/documents/a1bc046c-3f2f-498e-9e4e-36cd5697f348_e7f4b01e-3cf6-4b26-ab14-b0d6ec082768.html,,,,,, "methyl cis-1-{[(2,5-dimethylphenyl)acetyl]amino}-4-methoxycyclohexanecarboxylate",203313-47-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71af1f6e-bead-48ea-a7c4-6e8213734b8d/documents/a1bc046c-3f2f-498e-9e4e-36cd5697f348_e7f4b01e-3cf6-4b26-ab14-b0d6ec082768.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Reaction Mass of Cis-4-(isopropyl)cyclohexanemethanol and Trans-4-(isopropyl)cyclohexanemethanol,5502-75-0," In a repeated dose toxicity study performed in accordance with OECD test guideline No. 408 and in compliance with GLP, test substance was administered via the diet at 300, 1000 and 3000 ppm over a period of 13 weeks to Crl:CD(SD) rats. Control animals received basal diet. This study included a 10-week recovery period. During the study, clinical condition, detailed physical and arena observations, sensory reactivity, grip strength, motor activity, body weight, food consumption, visual water consumption, ophthalmoscopy, hematology (peripheral blood), blood chemistry, urinalysis, organ weight, sperm analysis, macropathology and histopathology investigations were undertaken. The dose levels for the 90-day study were selected based on the results of a 14-day dietary study, considered to be a supporting study. It was concluded that dietary administration of test substance to Crl:CD (SD) rats at dietary concentrations 300, 1000 or 3000 ppm for 13 weeks provided clear evidence of systemic exposure but no effects which were deemed to be adverse. There were no test item-related histopathological changes observed for any tissues examined in this study. Plasma biochemistry and urinalysis revealed several slight changes in composition, predominantly in females, which were indicative of adaptations of metabolism/excretion in the liver and kidneys. In the absence of any change in organ weight or any evidence of degenerative or functional change in the liver and kidneys during histopathological evaluation, the slight disturbances of biochemical and urine parameters were considered not to be adverse. Under the test conditions, the No Observed Adverse Effect Level (NOAEL) was concluded to be 3000 ppm (equivalent to 188 mg/kg bw/day in males and 220 mg/kg bw/day in females). In a 28-day toxicity study conducted in rodents to evaluate the repeated dose toxicity of the substance.  Doses for the 28-day study were selected based on the results of a 14-day study, considered to be a supporting study.  Oral (gavage) administration of the substance to Crl:CD (SD) rats for 28 days. Change to the liver were considered to be possible alterations to intra-hepatocellular fat metabolism/transport in the high dose animals, however there was no evidence of degenerative liver changes in either sex at any dose level and the findings suggest an adaptive change in the liver and not evidence of adverse toxic effects.  At 300 mg/kg/day, there was also a reduction in sperm velocity and increase in static sperm resulting in an overall reduction in the percentages of motile and progressively motile sperm.  These changes were considered not to be due to a primary toxicity of the substance itself. Instead, the sperm effects are considered to be due to oxidative stress occurring as a result of testicular metabolism of the substance made possible by high plasma levels of the substance and its metabolites following oral gavage administration of a high bolus dose (further discussed in Section 7.8).  Based on the data, the No Observed Adverse Effect Level was concluded to be 100 mg/kg/day. In the dietary OECD TG 408 study, no adverse effects were observed up to 3000 ppm (eq. to 188 mg/kg bw/day for males and 220 mg/kg bw for females). In the shorter-term OECD TG 407 and 421 reproductive toxicity screening study, both via gavage dose, effects were observed on sperm motility at similar or higher levels. These effects were considered to be specifically associated with bolus dosing.  To confirm that much higher plasma levels occur after oral gavage dosing than after dietary dosing, plasma levels of Mayol were measured during the OECD TG 408 dietary study and the oral gavage OECD TG 414 study. Though the full report is not yet available the evidence indicates that via gavage the peak plasma levels of Mayol are much higher than in the dietary study. These high plasma levels of Mayol show that the oral absorption is fast and high. It is anticipated that at levels < 1 mMol (ca 200 mg/kg bw) Mayol is metabolised/oxidised into its acid and conjugated. At higher levels Mayol as such escapes first pass metabolism in the liver and enters the systemic circulation and direct exposure to the male reproductive system occurs. All organs have the capability to further oxidise substances and also these organs. Compared to other organs the testes is somewhat hypoxic. When significant amounts of substance is oxidised within the testes the oxygen levels may be depleted (oxidative stress) such that it can affect sperm viability. As these effects are only seen at high dose levels that exceed a threshold that cannot be envisgned after exposure to humans, and metabolic overload is anticipated, these effects are not considered as relevant reproductive hazard effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/496d6f7b-b5a5-4409-81f5-f27ffd44d3e8/documents/IUC5-9decab7e-cde2-4289-99e8-079c0194443d_7341d5f3-80be-4674-b30d-8f754d3b3fee.html,,,,,, Reaction Mass of Cis-4-(isopropyl)cyclohexanemethanol and Trans-4-(isopropyl)cyclohexanemethanol,5502-75-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/496d6f7b-b5a5-4409-81f5-f27ffd44d3e8/documents/IUC5-9decab7e-cde2-4289-99e8-079c0194443d_7341d5f3-80be-4674-b30d-8f754d3b3fee.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,188 mg/kg bw/day,,rat Reaction Mass of Cis-4-(isopropyl)cyclohexanemethanol and Trans-4-(isopropyl)cyclohexanemethanol,5502-75-0," 1)  The oral LD50 was considered to be greater than 10,000 mg/kg bw in the albino rat. 2) Acute toxicity via inhalation route : waiver 3) The dermal LD50 of the test compound was determined to be greater than 2,000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/496d6f7b-b5a5-4409-81f5-f27ffd44d3e8/documents/IUC5-9bd7afd0-16c3-4615-a0f5-f49338796a6e_7341d5f3-80be-4674-b30d-8f754d3b3fee.html,,,,,, Reaction Mass of Cis-4-(isopropyl)cyclohexanemethanol and Trans-4-(isopropyl)cyclohexanemethanol,5502-75-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/496d6f7b-b5a5-4409-81f5-f27ffd44d3e8/documents/IUC5-9bd7afd0-16c3-4615-a0f5-f49338796a6e_7341d5f3-80be-4674-b30d-8f754d3b3fee.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Reaction Mass of Cis-4-(isopropyl)cyclohexanemethanol and Trans-4-(isopropyl)cyclohexanemethanol,5502-75-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/496d6f7b-b5a5-4409-81f5-f27ffd44d3e8/documents/IUC5-9bd7afd0-16c3-4615-a0f5-f49338796a6e_7341d5f3-80be-4674-b30d-8f754d3b3fee.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, Reaction mass of 3-[cis-4-(2-methylpropyl)cyclohexyl]propanal and 3-[trans-4-(2-methylpropyl)cyclohexyl]propanal,1254940-85-6,"Dietary repeated dose toxicity test (OECD TG 407): NOAEL is 42.7 mg/kg bw/day and >1137.8 mg/kg bw/day for females and males, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7230043c-2689-4321-bfd4-fef3888b37c1/documents/8e54743a-24ad-4f2c-ae2e-ee301fbf80f8_1cfde05a-5038-4110-89cc-0d7b4d3fc133.html,,,,,, Reaction mass of 3-[cis-4-(2-methylpropyl)cyclohexyl]propanal and 3-[trans-4-(2-methylpropyl)cyclohexyl]propanal,1254940-85-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7230043c-2689-4321-bfd4-fef3888b37c1/documents/8e54743a-24ad-4f2c-ae2e-ee301fbf80f8_1cfde05a-5038-4110-89cc-0d7b4d3fc133.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,42.7 mg/kg bw/day,,rat Reaction mass of 3-[cis-4-(2-methylpropyl)cyclohexyl]propanal and 3-[trans-4-(2-methylpropyl)cyclohexyl]propanal,1254940-85-6,Acute oral toxicity: LD50 is >2000 mg/kg bw in an OECD TG 423. Acute toxicity inhalation: LC50 is 2.26 mg/L in an OECD TG 403. Acute dermal toxicity: LD50 is >2000 mg/kg bw in an OECD TG 402. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7230043c-2689-4321-bfd4-fef3888b37c1/documents/IUC5-3318d308-37f2-4503-84e0-7603b96334f3_1cfde05a-5038-4110-89cc-0d7b4d3fc133.html,,,,,, Reaction mass of 3-[cis-4-(2-methylpropyl)cyclohexyl]propanal and 3-[trans-4-(2-methylpropyl)cyclohexyl]propanal,1254940-85-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7230043c-2689-4321-bfd4-fef3888b37c1/documents/IUC5-3318d308-37f2-4503-84e0-7603b96334f3_1cfde05a-5038-4110-89cc-0d7b4d3fc133.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Reaction mass of 3-[cis-4-(2-methylpropyl)cyclohexyl]propanal and 3-[trans-4-(2-methylpropyl)cyclohexyl]propanal,1254940-85-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7230043c-2689-4321-bfd4-fef3888b37c1/documents/IUC5-3318d308-37f2-4503-84e0-7603b96334f3_1cfde05a-5038-4110-89cc-0d7b4d3fc133.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Reaction mass of 3-[cis-4-(2-methylpropyl)cyclohexyl]propanal and 3-[trans-4-(2-methylpropyl)cyclohexyl]propanal,1254940-85-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7230043c-2689-4321-bfd4-fef3888b37c1/documents/IUC5-3318d308-37f2-4503-84e0-7603b96334f3_1cfde05a-5038-4110-89cc-0d7b4d3fc133.html,,inhalation,LC50,2.26 mg/L,adverse effect observed, Cyclohexanethiol,1569-69-3,"In the key acute oral toxicity study, the LD50 in rats was determined to be 1200 mg/kg bw (Lifestream Laboratories, 1970).In the key acute vapour inhalation toxicity study, the LC50 in rats was determined to be between 5.6 and 13.3 mg/l (Lifestream Laboratories, 1970).In the key acute dermal toxicity study, the LD50 in rats was determined to be 7.82 g/kg (Lifestream Laboratories, 1970). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ddf1fdb-7438-4361-929e-4c0cf734fc48/documents/IUC5-07fab539-2a5c-4f09-bea0-4833c73b4d53_3e2e7517-80a9-4932-b296-1e1a45b7c652.html,,,,,, Cyclohexanethiol,1569-69-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ddf1fdb-7438-4361-929e-4c0cf734fc48/documents/IUC5-07fab539-2a5c-4f09-bea0-4833c73b4d53_3e2e7517-80a9-4932-b296-1e1a45b7c652.html,,oral,LD50,"1,200 mg/kg bw",adverse effect observed, Cyclohexanethiol,1569-69-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ddf1fdb-7438-4361-929e-4c0cf734fc48/documents/IUC5-07fab539-2a5c-4f09-bea0-4833c73b4d53_3e2e7517-80a9-4932-b296-1e1a45b7c652.html,,dermal,LD50,"7,820 mg/kg bw",no adverse effect observed, 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol,93413-69-5,"A study (Wyeth-Ayerst Laboratories, 1985) using rat was available. The approx. LD50 for male was 672.7 mg/kg bw, for female was 336.4 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c5db3b2-d7df-4259-8edb-03ca5daf5cfa/documents/IUC5-a6c7bf94-4142-47ef-9199-c69e818deb1c_fe681627-3daa-4b9c-b4a6-876bd3188686.html,,,,,, 1-[2-(dimethylamino)-1-(4-methoxyphenyl)ethyl]cyclohexanol,93413-69-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c5db3b2-d7df-4259-8edb-03ca5daf5cfa/documents/IUC5-a6c7bf94-4142-47ef-9199-c69e818deb1c_fe681627-3daa-4b9c-b4a6-876bd3188686.html,,oral,LD50,336.4 mg/kg bw,adverse effect observed, 1-(2-amino-1-(4-methoxyphenyl)ethyl)cyclohexanol hydrochloride,130198-05-9,"The acute toxic class method was started at the dose level of 2000 mg/kg in female animals (n=3). All animals died, so the test was continued at the dose level of 200 mg/kg in female animals (n=3). No mortality occurred, so the test was repeated at the same dose level in male animals (n=3). No male animals died therefore the study was terminated after the 14 day observation period. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54b03a64-e600-4988-b624-e0c4a8204985/documents/IUC5-2ea3ec0c-ddc0-4478-a9ae-c499a5c858e7_e271db77-0d44-4153-9480-d93dbe9ecaf0.html,,,,,, trans-4-tert-Butylcyclohexanol,21862-63-5,"Acute oral toxicity: LD50 > 2000 mg/kg bw (EU method B.1 bis; GLP compliant). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The conducted study is considered reliable according to Klimisch Score 1. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a449ef0-d391-4f03-99e3-186b13c395ba/documents/IUC5-ddd97ce1-22a5-4ede-ae13-2d9176a9ec0d_65b1dd73-0afa-409a-b58e-25aea39e7fe4.html,,,,,, trans-4-tert-Butylcyclohexanol,21862-63-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a449ef0-d391-4f03-99e3-186b13c395ba/documents/IUC5-ddd97ce1-22a5-4ede-ae13-2d9176a9ec0d_65b1dd73-0afa-409a-b58e-25aea39e7fe4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Cyclohexanone oxime,100-64-1,"The critical endpoint of the toxicity of cyclohexanone oxime (CHO) is haematotoxicity. A reliable rat study (RL2) reveals a LOAEL of 0.25 mg/kg bw/day after 90 days of oral exposure. Effects at this dose level were increased reticulocytes, appearance of Howell-Jones bodies, anisocytosis and poikilocytosis, haemosiderose and extramedullary erythropoiesis in the spleen. According to the authors, the effects were considered to be not severe and recovery could be expected, so that this LOAEL can be considered as marginal. A reliable rat study with shorter exposure duration and studies on mice confirm the relevant endpoint at higher doses.No information is available for inhalation and dermal exposure ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5f63379-3aff-49a8-a404-dbfd4ad667e5/documents/IUC5-6853f6fc-d8e7-4e3d-9ed4-e5642c8e4b80_7e9ad58d-622f-43ff-b46e-38ccc569a760.html,,,,,, Cyclohexanone oxime,100-64-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5f63379-3aff-49a8-a404-dbfd4ad667e5/documents/IUC5-6853f6fc-d8e7-4e3d-9ed4-e5642c8e4b80_7e9ad58d-622f-43ff-b46e-38ccc569a760.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,250 ,, Cyclohexanone oxime,100-64-1,"The oral LD50 of cyclohexanone oxime (CHO) was 883 mg/kg bw in female and 1765 mg/kg bw in male rats, respectively. No information is available for the inhalation route.The dermal LD50 in rabbits was > 5000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5f63379-3aff-49a8-a404-dbfd4ad667e5/documents/IUC5-f1ec95f6-aae7-4510-acf3-73175be369aa_7e9ad58d-622f-43ff-b46e-38ccc569a760.html,,,,,, Cyclohexanone oxime,100-64-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5f63379-3aff-49a8-a404-dbfd4ad667e5/documents/IUC5-f1ec95f6-aae7-4510-acf3-73175be369aa_7e9ad58d-622f-43ff-b46e-38ccc569a760.html,,oral,LD50,882 mg/kg bw,adverse effect observed, Cyclohexanone oxime,100-64-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5f63379-3aff-49a8-a404-dbfd4ad667e5/documents/IUC5-f1ec95f6-aae7-4510-acf3-73175be369aa_7e9ad58d-622f-43ff-b46e-38ccc569a760.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Cyclohexanone, peroxide",12262-58-7," Introduction The study was designed to investigate the systemic toxicity and potential adverse effects of the test item on reproduction (including offspring development) and is designed to be compatible with the requirements of the OECD Guidelines for Testing of Chemicals No. 422 “Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test” (adopted 22 March 1996).   This study was also designed to be compatible with Commission Regulation (EC) No 440/2008 of 30 May 2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).   Methods……. The test item was administered by gavage to three groups, each of twelve male and twelve female Wistar Han™:RccHan™:WIST strain rats, for approximately six weeks to males and up to eight weeks to females including a two week pre-pairing phase, pairing, gestation and early lactation, at dose levels of 30, 100 or 200 mg/kg bw/day. A control group of twelve males and twelve females was dosed with vehicle alone (Polyethylene glycol 400).   Clinical signs, behavioral assessments, body weight change and food and water consumption were monitored during the study.    Pairing of animals within each dose group was undertaken on a one male: one female basis within each treatment group on Day 15 of the study, with females subsequently being allowed to litter and rear their offspring to Day 5 of lactation. Female 85 treated with 200 mg/kg bw/day was killedin extremison Day 3 of dosing and Male 73 was therefore not paired with any female.   During the lactation phase, daily clinical observations were performed on all surviving offspring, together with litter size and offspring weights and assessment of surface righting reflex.   Extensive functional observations were performed on five selected males from each dose group after the completion of the pairing phase, and for five selected parental females from each dose group on Day 4post partum. Hematology and blood chemistry were evaluated prior to termination on five selected males and females from each dose group.    Adult males were terminated on Day 43 or 44, followed by the termination of all surviving females and offspring on Day 5post partum. Any female which did not produce a pregnancy was terminated on Day 26post coitum. All animals were subjected to a gross necropsy examination and histopathological evaluation of selected tissues was performed.   Results……. Adult Responses Mortality There were no unscheduled deaths considered to be related to the systemic toxicity of the test item.   There were four premature decedents during the course of the study, two each from the 100 or 200 mg/kg bw/day dose groups; one female from either dose group was found dead whilst the other was killedin extremis. Three of these animals showed clinical signs of respiratory distress which correlated with microscopic changes in the trachea with the change considered to have been a major factor in the death of one female from each dose group; these clinical signs and microscopic changes and, thus the deaths, were considered likely to be due to an irritant nature of the test item and not an indication of its systemic toxicity. Microscopic examination of the tissues from the remaining female treated with 200 mg/kg bw/day showed marked inflammatory change in the reproductive tract and secondary lymphoid/cellular depletion and it was deemed likely that these changes were a result of parturition and unrelated to administration of the test item.   Clinical Observations Throughout the dosing period, there were no clinical signs considered to be related to the systemic toxicity of the test item.   At 200 mg/kg bw/day, individual animals of either sex surviving to the scheduled necropsy showed a few instances of noisy respiration mainly during the latter half of the treatment period with one of the males also showing noisy/laboured respiration and decreased respiratory rate on Day 35. These were deemed likely to be due to an irritant nature of the test item and not an indication of its systemic toxicity.   Behavioral Assessment At all dose levels, there were no changes in the behavioral parameters measured considered to be related to the systemic toxicity of the test item.   Functional Performance Tests There was no effect of treatment with the test item at any dose level on functional performance parameters in animals of either sex.   Sensory Reactivity Assessments Sensory reactivity scores across all test item-treated dose groups were similar to controls.   Body Weight There was no adverse effect of treatment with the test item on body weight development for animals of either sex during the course of the study.   Food Consumption There was no adverse effect of treatment with the test item on food consumption or food conversion efficiency for animals of either sex during the course of the study.   Water Consumption Visual inspection of water bottles did not indicate any differences for the animals given the test item in comparison with controls.   Reproductive Performance Mating There was no effect of treatment on mating performance.   Fertility Fertility remained unaffected by treatment with the test item at any dose level.   Gestation Lengths There were no treatment-related differences in gestation lengths in animals receiving the test item when compared with controls.   Litter Responses Offspring Litter Size, Sex Ratio and Viability There was no detrimental effect of treatment with the test item on corpora lutea count, number of implantations, pre- or post-implantation losses, litter size, sex ratio and subsequent offspring survival to Day 5 of age at any dose level.   Offspring Growth and Development There was no detrimental effect of treatment indicated by offspring body weight or body weight gain and litter weights, surface righting ability on Day 1 or clinical signs to Day 5 of age at any dose level.   Laboratory Investigations Hematology No treatment-related effects were detected in animals of either sex at any dose level.   Blood Chemistry No toxicologically significant effects were detected in animals of either sex at any dose level.   Pathology Necropsy Neither the type, incidence or distribution of macroscopic observations in surviving adult animals or offspring indicated any systemic effect of treatment up to a dose level of 200 mg/kg bw/day.   Organ Weights No toxicologically significant effects were detected in animals of either sex at any dose level.   Histopathology No findings were noted in the tissues examined from terminal sacrifice animals which could be unequivocally related to administration of the test item at dose levels up to 200 mg/kg bw/day.   Of the four premature decedent animals, three showed inflammatory changes in the trachea with the change considered to have been a major factor in the premature death of two of the animals. These changes are unusual, correlated with the respiratory clinical sign noted and may be indicative of reflux after gavage dosing and thus related to test item irritancy rather than its toxicity.   Conclusion The oral (gavage) administration of Cyclohexanone peroxide (CAS# 012262-58-7) to Wistar Han™:RccHan™:WIST strain rats, at dose levels of up to 200 mg/kg bw/day resulted in the premature death of two females each from the 100 or 200 mg/kg bw/day dose groups. Prior to death, these early decedents showed clinical signs of respiratory distress which correlated with inflammatory changes observed histopathologically in the trachea in three of these animals. Some surviving animals of either sex receiving 200 mg/kg bw/day also showed a few instances of respiratory signs during dosing, but there were no histopathology correlates. For the surviving animals, there was no adverse effect of treatment with the test item at any dose level on body weight development, dietary intake, hematology or blood chemistry parameters and organ weights. There were no treatment-related macroscopic findings for any of these terminal animals or any histopathology observations that could be unequivocally related to the administration of the test item. Based on the available data, the premature deaths of three females were considered likely due to an irritant nature of the test item rather than an indication of its systemic toxicity and, as such the ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity, was considered to be 200 mg/kg bw/day within the confines of this study.   There was no effect of treatment on mating performance, fertility, gestation length or any of the maternal and offspring parameters measured and The ‘No Observed Effect Level’ (NOEL) for reproductive toxicity, within the confines of this screening study, was considered to be 200 mg/kg bw/day.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/917f3626-aa84-49ac-9395-d1d41d0b6244/documents/c0fdc804-cf02-4918-a9a6-f765bbb8f8b3_daca0eea-794c-4e4c-829a-601f6769e8e0.html,,,,,, "Cyclohexanone, peroxide",12262-58-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/917f3626-aa84-49ac-9395-d1d41d0b6244/documents/c0fdc804-cf02-4918-a9a6-f765bbb8f8b3_daca0eea-794c-4e4c-829a-601f6769e8e0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Cyclohexanone, peroxide",12262-58-7," The oral LD50 is 1.08 ml per kg body weight which corresponds to 1242 mg/kg bw (the density is 1.15). From the results of an acute inhalation study it is concluded that the 4-hour LC50 of, Cyclonox LE-50 is higher than 5.0 ppm (>29 mg/m3). The study is not suitable fro C&L. Only one concentraton was tested and the test atmsphere was based on the maximum attainable concentration by evaporation at 22 degrees celcius. There is no acute dermal toxicity study. According to REACH Annex VIII column II acute studies do not need to be conducted when 'the substance is classified as skin corrosion' ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/917f3626-aa84-49ac-9395-d1d41d0b6244/documents/c4f02d95-ca4a-4001-bef2-87137c284dc0_daca0eea-794c-4e4c-829a-601f6769e8e0.html,,,,,, "Cyclohexanone, peroxide",12262-58-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/917f3626-aa84-49ac-9395-d1d41d0b6244/documents/c4f02d95-ca4a-4001-bef2-87137c284dc0_daca0eea-794c-4e4c-829a-601f6769e8e0.html,,oral,LD50,"1,242 mg/kg bw",adverse effect observed, Cyclohexapentylose,10016-20-3,"Since 20% .alpha.-CD induced no changes of any toxicological significance which were not also induced by 20% lactose, it appears that these test substance is as safe as lactose. Moreover, the observed changes appeared to be reversible. Because the findings produced by 20% lactose are not considered to represent toxic effects, it also appears that even 20% of the test substances cannot be considered a toxic effect level. Therefore it is concluded that under the conditions of the study, dietary levels of up to 20% .alpha.-CD are tolerated without obvious signs of toxicity.Two chronic (52 weeks) feeding studies with dogs using the read-across substance .beta.-cyclodextrin have been performed; both result in a NOAEL of 50.000 ppm (highest dietary level tested). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/71f1d4fe-8db4-4204-ba10-a47faeba0077/documents/IUC5-e957c0b8-91a4-44c2-a252-1bb202a0e29b_8cbf603f-7152-4a59-9379-d211c738df6d.html,,,,,, Cyclohexapentylose,10016-20-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/71f1d4fe-8db4-4204-ba10-a47faeba0077/documents/IUC5-e957c0b8-91a4-44c2-a252-1bb202a0e29b_8cbf603f-7152-4a59-9379-d211c738df6d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"12,764 mg/kg bw/day",,rat Cyclohexapentylose,10016-20-3,".Alpha.-cyclodextrin is practical nontoxic after oral, dermal and inhalative administration. Due to the physico-chemical properties (molecular weight, solubility) a significant resorption via dermal or inhalativ route is not expected. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71f1d4fe-8db4-4204-ba10-a47faeba0077/documents/IUC5-b31f1720-67be-403b-bf8d-7b89c3a44eea_8cbf603f-7152-4a59-9379-d211c738df6d.html,,,,,, Cyclohexapentylose,10016-20-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71f1d4fe-8db4-4204-ba10-a47faeba0077/documents/IUC5-b31f1720-67be-403b-bf8d-7b89c3a44eea_8cbf603f-7152-4a59-9379-d211c738df6d.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Cyclohexapentylose,10016-20-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71f1d4fe-8db4-4204-ba10-a47faeba0077/documents/IUC5-b31f1720-67be-403b-bf8d-7b89c3a44eea_8cbf603f-7152-4a59-9379-d211c738df6d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Cyclohexapentylose,10016-20-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71f1d4fe-8db4-4204-ba10-a47faeba0077/documents/IUC5-b31f1720-67be-403b-bf8d-7b89c3a44eea_8cbf603f-7152-4a59-9379-d211c738df6d.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Cyclohexene,110-83-8,"In oral repeated dose studies in rats, salivation is observed in both sexes at 150mg/kg b.w. and above. The NOAEL is considered to be 50mg/kg b.w./day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8af851a2-b156-4d37-8ab6-8e7529871a7a/documents/IUC5-9415d1f1-11ff-4e2f-a11a-0a8255f26eb5_293c25f8-6d8c-4b6d-864f-440d62224cdf.html,,,,,, Cyclohexene,110-83-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8af851a2-b156-4d37-8ab6-8e7529871a7a/documents/IUC5-9415d1f1-11ff-4e2f-a11a-0a8255f26eb5_293c25f8-6d8c-4b6d-864f-440d62224cdf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Cyclohexene,110-83-8,The LD50 values are between 1000 and 2000mg/kg b.w. for both sexes. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8af851a2-b156-4d37-8ab6-8e7529871a7a/documents/IUC5-74f2ad55-d882-4ab5-aa9b-1d902905d84a_293c25f8-6d8c-4b6d-864f-440d62224cdf.html,,,,,, Cyclohexene,110-83-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8af851a2-b156-4d37-8ab6-8e7529871a7a/documents/IUC5-74f2ad55-d882-4ab5-aa9b-1d902905d84a_293c25f8-6d8c-4b6d-864f-440d62224cdf.html,,oral,LD50,"1,000 mg/kg bw",, Cyclohexyl isocyanate,3173-53-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c66d097d-1b36-4fec-af53-d40092e39ba0/documents/1b360bf9-dfaf-4879-8016-4b22014f619e_1d1b14d4-25f2-41d4-b41f-0cf14ded5aa2.html,,oral,LD50,>=335 mg/kg bw,adverse effect observed, Cyclohexyl methacrylate,101-43-9," oral registered substance cyclohexylmethacrylate (CAS# 101-43-9): ca. 100 -day oral gavage study (OECD 422/OECD 408), rat: NOAEL = 300 mg/kg bw/d (BASF SE, 2018) registered substance cyclohexylmethacrylate (CAS# 101-43-9): 28-day oral gavage study (OECD 407 ), rat: NOAEL = 300 mg/kg bw/d (BASF SE, 2010) analogous substance cyclohexanone (CAS# 108-94-1): 90-day drinking water study (OECD 408), rat: NOAEL = 143 mg/kg bw/d (BASF SE, 1994) analogous substance cyclohexanone (CAS# 108-94-1): 2-y drinking water study (equivalent to OECD 453), rat: NOAEL = 462 mg/kg bw/d (Lijinsky et al., 1986) analogous substance methylmethacrylate (CAS# 80-62-6): 2-y drinking water study, rat: NOAEL of >= 90.3 mg/kg bw/day and 193.8 mg/kg bw/day, for males and females, respectively (Borzelleca et al., 1964)   inhalation hydrolysis product cyclohexanol (CAS# 108-93-0), inhalation screening study, rat: NOAEC maternal toxicity 610 mg/m³; NOAEC fertility = 1640 mg/m³ (US EPA, 2010) hydrolysis product methacrylic acid (CAS# 79-41-4): 90-day whole body inhalation study (OECD 413), rat: NOAEC systemic = 352 mg/m³; LOAEC local =  (BASF SE, MAA Task Force, 2008) analogous substance n-butylmethacrylate (CAS# 97-88-1): 28/14-d whole body inhalation study (OECD 412), rat: NOAEC systemic = 11175 mg/m³; NOAEC local = 1832 mg/m³ (Methacrylate Producers Association, Hagan et al., 1993) analogous substance methylmethacrylate (CAS# 80-62-6): 90-day inhalation study (equivalent to OECD 413), mouse: NOAEC systemic = 12300 mg/m³; NOAEC local = 4100 mg/m³ (Rohm & Haas, 1980) analogous substance methylmethacrylate (CAS# 80-62-6): 90-day inhalation study (equivalent to OECD 413), rat: NOAEC systemic = 2050 and 4100 mg/m³ for male and female rats, respectively (Rohm & Haas, 1980) analogous substance methylmethacrylate (CAS# 80-62-6): 2-y whole body inhalation study (equivalent to OECD 453), rat: NOAEC systemic = 1640 mg/m³; NOAEC local = 104 mg/m³ (Lomax et al., 1997) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65fc106d-fb5c-45a1-99a2-c2325280e329/documents/IUC5-61221541-760c-48bd-bdb4-5644ad7b1163_a0295b60-ec24-4347-a7d9-a2af07f85e76.html,,,,,, Cyclohexyl methacrylate,101-43-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65fc106d-fb5c-45a1-99a2-c2325280e329/documents/IUC5-61221541-760c-48bd-bdb4-5644ad7b1163_a0295b60-ec24-4347-a7d9-a2af07f85e76.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Cyclohexyl methacrylate,101-43-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65fc106d-fb5c-45a1-99a2-c2325280e329/documents/IUC5-61221541-760c-48bd-bdb4-5644ad7b1163_a0295b60-ec24-4347-a7d9-a2af07f85e76.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,610 mg/m3,,rat Cyclohexyl methacrylate,101-43-9, Cyclohexylmethacrylate is nontoxic after single oral application (LD50 rat oral 12900 mg/kg) and after a single dermal application (LD50 rat dermal > 2000 mg/kg). A low acute inhalation toxicity is expected based on study results with the hydrolysis products cyclohexanol and methacrylic acid as well as the lower methacrylate ester methyl methacrylate (the LC50 rat inhalation is 29.8 mg/L). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65fc106d-fb5c-45a1-99a2-c2325280e329/documents/IUC5-1dd90048-f7d2-4a29-8560-4baa067e3931_a0295b60-ec24-4347-a7d9-a2af07f85e76.html,,,,,, Cyclohexyl methacrylate,101-43-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65fc106d-fb5c-45a1-99a2-c2325280e329/documents/IUC5-1dd90048-f7d2-4a29-8560-4baa067e3931_a0295b60-ec24-4347-a7d9-a2af07f85e76.html,,oral,LD50,"12,900 mg/kg bw",no adverse effect observed, Cyclohexyl methacrylate,101-43-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65fc106d-fb5c-45a1-99a2-c2325280e329/documents/IUC5-1dd90048-f7d2-4a29-8560-4baa067e3931_a0295b60-ec24-4347-a7d9-a2af07f85e76.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Cyclohexyl methacrylate,101-43-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65fc106d-fb5c-45a1-99a2-c2325280e329/documents/IUC5-1dd90048-f7d2-4a29-8560-4baa067e3931_a0295b60-ec24-4347-a7d9-a2af07f85e76.html,,inhalation,LC50,"29,800 mg/m3",no adverse effect observed, Cyclohexyl phenyl ketone,712-50-5, The LD50 in female rats was found to be greater than 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55de8955-09b0-4635-91ef-48a353eb8f7b/documents/IUC5-d6959c65-a4f3-48fa-8119-c25bab3bb5bf_f73a4b91-8191-48a7-95a4-7b6301d8d105.html,,,,,, Cyclohexyl phenyl ketone,712-50-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55de8955-09b0-4635-91ef-48a353eb8f7b/documents/IUC5-d6959c65-a4f3-48fa-8119-c25bab3bb5bf_f73a4b91-8191-48a7-95a4-7b6301d8d105.html,,oral,LD50,"2,000 mg/kg bw",, Cyclohexyldimethoxymethylsilane,17865-32-6," There are no sub-chronic toxicity data for the registered substance, therefore, data on an analogue of its hydrolysis product, dicyclopentylsilanediol (CAS 211495 -85 -1), are read-across. In a 90-day oral repeated dose toxicity study in rats conducted according to a protocol equivalent to OECD Test Guideline 408 and in compliance with GLP (certificate not included), the NOAEL was concluded to be 200 mg/kg bw/day for females and 1000 mg/kg bw/day for males (Mitsubishi Chemical Safety Institute, 2000). A molecular weight correction is used to establish the corresponding dose of parent dicyclopentyldimethoxysilane that would provide 200 mg/kg bw/day of dicyclopentylsilanediol. The NOAEL for dicyclopentyldimethoxysilane is therefore approximately 230 mg/kg bw/day. No further molecular weight correction is introduced for read-across to cyclohexyl(dimethoxy)methylsilane. In a sub-acute 28-day oral gavage study conducted according to OECD Test Guideline 407 and in compliance with GLP, the NOAEL for cyclohexyl(dimethoxy)methylsilane was greater than or equal to 1000 mg/kg bw/day in rats (Safepharm Laboratories Ltd., 1996a). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4abd78a1-858f-42e1-b481-a595062ba725/documents/fe8d63d1-f287-4670-891e-d13202e7b308_38a6f4eb-678b-42f1-8b84-70b368ccfa7d.html,,,,,, Cyclohexyldimethoxymethylsilane,17865-32-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4abd78a1-858f-42e1-b481-a595062ba725/documents/fe8d63d1-f287-4670-891e-d13202e7b308_38a6f4eb-678b-42f1-8b84-70b368ccfa7d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,230 mg/kg bw/day,,rat Cyclohexyldimethoxymethylsilane,17865-32-6," In an acute oral toxicity study conducted according to the now deleted OECD Test Guideline 401 and in compliance with GLP (Safepharm Laboratories Ltd., 1995a), the LD50 for cyclohexyldimethoxymethylsilane was greater than 2000 mg/kg bw in rats. In an acute aerosol inhalation study conducted using a protocol comparable to OECD Test Guideline 403 and in compliance with GLP (Huntingdon Research Centre Ltd., 1990), the LC50 for cyclohexyldimethoxymethylsilane was greater than 5.53 mg/l in rats (whole-body). In an acute dermal toxicity study conducted according to OECD Test Guideline 402 and in compliance with GLP (Safepharm Laboratories Ltd., 1995b), the LD50 for cyclohexyldimethoxymethylsilane was greater than 2000 mg/kg bw in rats. There were no signs of systemic toxicity or dermal irritation. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4abd78a1-858f-42e1-b481-a595062ba725/documents/ffd48b16-a425-4670-8092-2033c6dae818_38a6f4eb-678b-42f1-8b84-70b368ccfa7d.html,,,,,, Cyclohexyldimethoxymethylsilane,17865-32-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4abd78a1-858f-42e1-b481-a595062ba725/documents/ffd48b16-a425-4670-8092-2033c6dae818_38a6f4eb-678b-42f1-8b84-70b368ccfa7d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Cyclohexyldimethoxymethylsilane,17865-32-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4abd78a1-858f-42e1-b481-a595062ba725/documents/ffd48b16-a425-4670-8092-2033c6dae818_38a6f4eb-678b-42f1-8b84-70b368ccfa7d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Cyclohexyldimethoxymethylsilane,17865-32-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4abd78a1-858f-42e1-b481-a595062ba725/documents/ffd48b16-a425-4670-8092-2033c6dae818_38a6f4eb-678b-42f1-8b84-70b368ccfa7d.html,,inhalation,LC50,5.53 mg/m3,no adverse effect observed, Cyclohexyldimethylamine,98-94-2,"The repeated dose toxicity of the substance was investigated in sub-acute studies in rats using inhalation, gavage and dietary exposure. The results of these studies demonstrate an absence of systemic toxicity and show that the primary effects of exposure to the test material are local and attributable to its corrosive nature. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8559baf1-b65c-4acd-8632-38c4ab88cb7c/documents/IUC5-b726386f-76ff-4178-bdbf-beda7086941b_1f2d7120-8fac-47ba-bf65-56f966d71a98.html,,,,,, Cyclohexyldimethylamine,98-94-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8559baf1-b65c-4acd-8632-38c4ab88cb7c/documents/IUC5-b726386f-76ff-4178-bdbf-beda7086941b_1f2d7120-8fac-47ba-bf65-56f966d71a98.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,85 mg/kg bw/day,,rat Cyclohexyldimethylamine,98-94-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8559baf1-b65c-4acd-8632-38c4ab88cb7c/documents/IUC5-b726386f-76ff-4178-bdbf-beda7086941b_1f2d7120-8fac-47ba-bf65-56f966d71a98.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,104 mg/m3,,rat Cyclohexyldimethylamine,98-94-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8559baf1-b65c-4acd-8632-38c4ab88cb7c/documents/IUC5-b726386f-76ff-4178-bdbf-beda7086941b_1f2d7120-8fac-47ba-bf65-56f966d71a98.html,Repeated dose toxicity – local effects,inhalation,NOAEC,104 mg/m3,adverse effect observed,rat Cyclohexyldimethylamine,98-94-2,"Acute oral, inhalation and dermal studies are available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8559baf1-b65c-4acd-8632-38c4ab88cb7c/documents/IUC5-268f7634-48a9-4a0c-8a76-bf831619b1ba_1f2d7120-8fac-47ba-bf65-56f966d71a98.html,,,,,, Cyclohexyldimethylamine,98-94-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8559baf1-b65c-4acd-8632-38c4ab88cb7c/documents/IUC5-268f7634-48a9-4a0c-8a76-bf831619b1ba_1f2d7120-8fac-47ba-bf65-56f966d71a98.html,,oral,LD50,272 mg/kg bw,adverse effect observed, Cyclohexyldimethylamine,98-94-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8559baf1-b65c-4acd-8632-38c4ab88cb7c/documents/IUC5-268f7634-48a9-4a0c-8a76-bf831619b1ba_1f2d7120-8fac-47ba-bf65-56f966d71a98.html,,dermal,LD50,380 mg/kg bw,adverse effect observed, Cyclohexyldimethylamine,98-94-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8559baf1-b65c-4acd-8632-38c4ab88cb7c/documents/IUC5-268f7634-48a9-4a0c-8a76-bf831619b1ba_1f2d7120-8fac-47ba-bf65-56f966d71a98.html,,inhalation,LC50,"1,700 mg/m3",adverse effect observed, Cyclohexylidenebis[tert-amyl] peroxide,15667-10-4," Read across study The purpose of this Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test was to provide initial information concerning the effect of the test item cyclohexylidenebis[tert-butyl] peroxide on male and female reproductive performance such as gonadal function, mating behavior, conception, pregnancy, parturition as well as on development of the F1 offspring from conception to day 4 post-partum associated with oral administration to rats at repeated doses ( Toxi-Coop Zrt., 2012). Four groups of Hsd.Brl.Han:Wist rats (n=17/sex in the control and middle dose group and n= 12 in the low and high dose groups) were administered orally (by gavage) once a day at 0 (vehicle only), 40, 200 and 600 mg/kg bw/day at concentrations of 20, 100 and 300 mg/mL corresponding to 2 mL/kg bw dose volume. Group of satellite animals (5 animals/sex/group; control and 200 mg/kg bw/day group) were involved in the study to ensure the appropriate number of litters in these groups. The suitability of the chosen vehicle for the test item at the intended concentrations was analytically verified up front. A sufficient stability and homogeneity in the chosen vehicle were verified over the range of relevant concentrations. Cyclohexylidenebis[tert-butyl] peroxide proved to be stable in sunflower oil formulations at room temperature for one day and at 5 ± 3°C for 3 days in a concentration range of 1 and 500 mg/mL. Concentration of the test item in the dosing solutions varied from 103 % to 109 % of nominal concentrations at all analytical occasions, thereby confirming proper dosing. All animals of the parent (P) generation received test item or vehicle prior to mating (14 days) and throughout mating. Test item or vehicle was administered to male animals post mating up to the day before the necropsy. For females, test item was administered through the gestation period and up to lactation days 3 – 10, i.e. up to the day before the necropsy. Observations included mortality, clinical signs, body weight, food consumption, mating, pregnancy and delivery process, as well as development of pups. The dams were allowed to litter, and rear their young up to termination on day 4 postpartum. Pups were weighed and observed for possible abnormalities. All parental animals were subjected to gross pathology one day after the last treatment and offspring were euthanized. Histopathology examination was performed on reproductive organs and pituitary in the control and high dose groups and in not mated and non-pregnant females and males cohabited with in the low and middle doses. Besides full histopathology examinations performed on preserved organs and tissue of randomly selected animals in the control and high dose group and on animals which were found to be dead, the kidneys and liver of animals at the low and medium doses were processed as well and evaluated histologically due to histopathology findings in kidneys of the high dose animals and macroscopic observations on the liver. The results were interpreted comparing treatment groups with respect to controls, which were treated concurrently with vehicle (sunflower oil) only. There was no test item related mortality at any dose level (600, 200 and 40 mg/kg bw/day). One dam administered with 200 mg/kg bw/day was found dead on the day of delivery. For this particular case, there were no preceding clinical signs and no macroscopic changes were found in the organs at the necropsy. Histological examination revealed severe alveolar emphysema and moderate hemorrhage in the lungs and moderate hemorrhage in the uterus, in connection with a probably shock, as cause of death, which cannot be linked to the test item exposure. Salivation related to the test item was observed in slight or moderate degree in male and female animals at 600 mg/kg bw/day and 200 mg/kg bw/day from Day 9 up to the end of the treatment period. No toxic signs related to the test item were found at general daily or detailed weekly clinical observations or at the functional observations. The behavior and physical condition of animals were considered to be normal during the entire observation period (pre-mating, mating, post-mating, gestation and lactation periods). The mean body weight gain was reduced with respect to controls in male animals at 600 mg/kg bw/day resulting in a slightly reduced body weight towards the end of the treatment period (between Days 27 and 41) and a reduced total body weight gain. However the differences in body weight with respect to control were small (= -6 %). The body weight development of parental female animals was undisturbed in the course of the pre-mating, mating, post-mating, gestation and lactation periods. The mean daily food consumption was transiently reduced in male and female animals at 600 mg/kg bw/day compared to their control group during the first two weeks of the study. There were no significant differences in the mean daily food consumption between the control and test item treated groups in the course of following weeks of the treatment. There were no test item related changes in the examined hematological and blood coagulation parameters in male or female animals at any dose level (600, 200 or 40 mg/kg bw/day). A slightly higher mean concentration of cholesterol levels were detected in male and female animals at 600 mg/kg bw/day and a test item influence on the hepatic system cannot be excluded. Test item related renal and hepatic changes were observed at 600 mg/kg bw/day: in male animals, the kidneys were found to be pale and the liver was dark; in female animals, dark and enlarged liver was detected with high incidence. Dark color of the liver was also noted for some male (2/17) and female (3/17) animals at 200 mg/kg bw/day. The mean kidney weights (absolute and relative to body and brain weights) were statistically significantly elevated in male animals at 600 mg/kg bw/day with respect to controls. The mean liver weights (absolute and relative to body and brain weights) were statistically significantly higher than in the control group in male and female animals at 600 mg/kg bw/day. Also at 200 mg/kg bw/day, the weights of liver and kidney of male animals were slightly elevated while reaching statistical significance but remaining within the range of the historical control values. Similarly, in female animals a statistically significant increase in liver weight was observed at a dose 200 mg/kg bw/day but the values remained within the range of the historical control data. Histopathology investigations revealed test item related renal lesions in male animals at 600 mg/kg bw/day. In the kidney of male animals treated with the high dose, hyaline-like droplets occurred in the epithel cells of some proximal convoluted tubules and dilatation of tubuli in the distal area, at the border of cortical - medullary region was detected (“hyaline droplet nephropathy of male rats”). These findings were not seen in the kidneys of high dose female animals as well as in male or female animals of the middle or low dose groups. Hyaline droplet nephropathy is often associated with interference to a-2µ-globulin. If this is the case the observed nephropathy is specific to the male rat and has no relevance to humans. Under the conditions of the present study, cyclohexylidenebis[tert-butyl] peroxide caused salivation (male and female), slightly reduced body weight gain (male) and food consumption (male and female), higher level of serum cholesterol (male and female), and changes in organ pathology [pale kidneys in male animals, dark liver (male and female) enlargement of liver (female), higher kidney (male) and liver weights (male and female), hyaline-like droplets in the epithel cells of proximal convoluted tubules and dilatation of distal tubuli (male) following an oral administration at 600 mg/kg bw/day to Hsd.Brl.Han:Wistar rats during the Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test. At 200 mg/kg bw/day, salivation and slight changes in organ pathology (dark color changes of the liver in male and female animals, higher kidney weights in male animals, and higher liver weights in male and female animals) were detected. However, no effect on liver and kidney function neither any histopathological effects were noted, and the observed weight changes remained within the range of the historical control data. At 40 mg/kg bw/day, there was no test item related effect. Based on these observations the No Observed Adverse Effect Levels (NOAEL) were determined as follows: NOAEL for male rats: 200 mg/kg bw/day NOAEL for female rats: 200 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/541042c5-5b46-42cd-8606-0fb42d192e79/documents/785cbbe2-30aa-4fc5-a206-f234c31dcca4_b6fa7df9-3e76-4e37-8da7-48a1f10ddda1.html,,,,,, Cyclohexylidenebis[tert-amyl] peroxide,15667-10-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/541042c5-5b46-42cd-8606-0fb42d192e79/documents/785cbbe2-30aa-4fc5-a206-f234c31dcca4_b6fa7df9-3e76-4e37-8da7-48a1f10ddda1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Cyclohexylidenebis[tert-amyl] peroxide,15667-10-4," Acute oral toxicity The single-dose oral toxicity of Lupersol 531 -80M was evaluated in Sprague-Dawley rats (Douds, 1995a). A limit test was performed in which one group of five male and five female rats received a single oral administration of the test article at a dose of 5000 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all limit test animals at scheduled euthanasia (day 14). No mortality occurred during the limit test. The most notable clinical abnormalities observed during the study included urine stain and dark material around the facial area. Body weight gain was noted for all animals during the test period. No significant gross internal findings were observed at necropsy on study day 14. Under the conditions of this test, the acute oral LD0 of Lupersol 531 -80M was estimated to be greater than 5000 mg/kg in the rat. Acute dermal toxicity The single-dose dermal toxicity of Lupersol 531-80M was evaluated in Sprague-Dawley rats (Douds, 1995b). A limit test was performed in which one group of five male and five female rats received a single dermal administration of the test article at a dose of 2000 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all limit test animals at the time of scheduled euthanasia (day 14). No mortality occurred during the limit test. The most notable clinical abnormalities observed during the study included urine stain and dark material around the facial area which occurred on study days 0 and 1. Dermal irritation was noted at the site of test article application. Body weight loss was noted for one female rat during the study day 0-7 body weight interval. Body weight gain was noted for all other animals during the test period. No gross internal findings were observed at necropsy on study day 14. Under the conditions of this test, the acute dermal LD0 of Lupersol 531 -80M was estimated to be greater than 2000 mg/kg in the rat. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/541042c5-5b46-42cd-8606-0fb42d192e79/documents/e2529421-fea7-4b7e-a750-b20e5e21da9e_b6fa7df9-3e76-4e37-8da7-48a1f10ddda1.html,,,,,, Cyclohexylidenebis[tert-amyl] peroxide,15667-10-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/541042c5-5b46-42cd-8606-0fb42d192e79/documents/e2529421-fea7-4b7e-a750-b20e5e21da9e_b6fa7df9-3e76-4e37-8da7-48a1f10ddda1.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Cyclohexylidenebis[tert-amyl] peroxide,15667-10-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/541042c5-5b46-42cd-8606-0fb42d192e79/documents/e2529421-fea7-4b7e-a750-b20e5e21da9e_b6fa7df9-3e76-4e37-8da7-48a1f10ddda1.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Cyclohexylidenebis[tert-butyl] peroxide,3006-86-8,"Based on the results of the 90-day repeated dose study, the NOAEL was determined to be 150 mg/kg bw/d for male and female Wistar rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP and guideline study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79a91098-47b3-4f7f-abc8-b724c6c617c6/documents/6fa0cc60-f0a2-408f-bac0-44ede8f269dc_9b733e12-6628-4447-91a2-fbcc01b95451.html,,,,,, Cyclohexylidenebis[tert-butyl] peroxide,3006-86-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79a91098-47b3-4f7f-abc8-b724c6c617c6/documents/6fa0cc60-f0a2-408f-bac0-44ede8f269dc_9b733e12-6628-4447-91a2-fbcc01b95451.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Cyclohexylidenebis[tert-butyl] peroxide,3006-86-8, In an acute oral toxicity study with cyclohexylidenebis[tert-butyl] peroxide in rats a LD50 value of 16653 mg/kg bw with a confidence interval of 11912 to 23279 mg/kg bw was determined. No acute inhalation study is available. In an acute dermal toxicity study with cyclohexylidenebis[tert-butyl] peroxide in rabbits a LD50 value of > 2000 mg/kg bw was determined. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79a91098-47b3-4f7f-abc8-b724c6c617c6/documents/1085d020-68bc-4134-872c-91d810ee99e5_9b733e12-6628-4447-91a2-fbcc01b95451.html,,,,,, Cyclohexylidenebis[tert-butyl] peroxide,3006-86-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79a91098-47b3-4f7f-abc8-b724c6c617c6/documents/1085d020-68bc-4134-872c-91d810ee99e5_9b733e12-6628-4447-91a2-fbcc01b95451.html,,oral,LD50,"16,653 mg/kg bw",adverse effect observed, Cyclohexylidenebis[tert-butyl] peroxide,3006-86-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79a91098-47b3-4f7f-abc8-b724c6c617c6/documents/1085d020-68bc-4134-872c-91d810ee99e5_9b733e12-6628-4447-91a2-fbcc01b95451.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Cyclohexylmethyl-4-biphenyl acetate,1609672-24-3,Oral LD50 (rat): > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce149d23-44c6-4299-9966-aaa6a64dffb9/documents/IUC5-4d7fc8d8-025f-4303-9799-0865d22151fc_99928ac5-3a40-467a-ab2f-77a7b8bd9b8a.html,,,,,, Cyclohexylmethyl-4-biphenyl acetate,1609672-24-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce149d23-44c6-4299-9966-aaa6a64dffb9/documents/IUC5-4d7fc8d8-025f-4303-9799-0865d22151fc_99928ac5-3a40-467a-ab2f-77a7b8bd9b8a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, cyclomaltodextrin glucanotransferase,9030-09-5," Cyclomaltodextrin glucanotransferase was not tested for acute oral toxicity, however, a repeated dose 13-week oral toxicity was available. The administration of CGT-ase SP 501, PPA 4357 at dosages between 0.1 and 2.6 g TOS/kg/day for 13 weeks did not produce any evidence of toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/386ab32d-6b0d-4f72-951f-f39fe35d5d3a/documents/c70937d1-ad5f-49b4-be1d-bc2454daf3df_d04a5955-f00f-40f5-aa4a-50b21d892039.html,,,,,, "Cycloocta-1,5-diene",111-78-4,"In an OECD 408 study the test substance was daily administrated by oral route to Wistar rats at nominal concentrations of 50, 150 and 450 mg/kg/day and induced dose related clinical symptoms (Hüls AG 1997).  The predominant clinical symptom was lethargy sometimes associated with ataxia, abnormal gait, closed eyes or  piloerection. At the end of the treatment period animals of all dose groups showed less or no clincal symptoms after application of the test substance. During treatment period the high dose male and female group showed a reduction in bodyweight and an increased food conversion rate and an increase in relative liver weights. High dose females showed also an increased relative kidney weight. In line with the increase in relative liver weight hepatocellular hypertrophy was noted in high dose male and females. The male and female medium dose group showed also hepatocellular hypertrophy. All these findings were considered to be test substance-related. For all the effects described evidence of reversibility was found after two weeks without treatment. It is suggested that the reversible liver changes observed are an expression of an adaptive response of the liver to the test substance. As such, it is generally not considered as adverse effect (Popp JA and Cattley RC (1991). Therefore, in the experimental conditions of the study, the no-observed-adverse-effect level (NOAEL) is 50 mg/kg/day. In a short term inhalation study, male rats were exposed to 0, 50, 150 and 500 ppm 1,5 -cyclooctadiene (DuPont 1996). In rats exposed to 500 ppm there was an absence of alerting response toward the end of the daily 6-hours exposures. These rats appeared to recover within 1/2 hour after exposure. No other test substance-related changes in clinical signs or body weight parameters were observed.  Based on a decreased altering response observed in rats during exposure at 500 ppm, and on the effects observed in the nose, kidney and urine in rats at this concentration, the no-observed-effect-level (NOEL) in this study was considered to be 150 ppm. On the basis of a 14-day dose range finding study in male and female Wistar rats with dose levels of 50, 150, and 450 mg/kg body weight day the following conclusions can be made (BSL 2023):1,5-Cyclooctadiene had an effect on body weight and food consumption in males in the HD group in the first week of treatment. Reduced spontaneous activity was also observed in these animals during the last 4 days of treatment. In addition, 1,5-Cyclooctadiene led most likely to an increase in liver weight in both males and females in the HD group. A possible effect on the weight of adrenal glands, epididymides and ovaries was noted. Adequate dose groups for the subsequently performed OECD 421 study were derived. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38e29c4e-8f4c-4f67-bfd5-eb444343c1ca/documents/c05c242e-a43b-444b-b60c-41231a15b396_a8b505c0-1567-4656-b3dc-68305a3fa822.html,,,,,, "Cycloocta-1,5-diene",111-78-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38e29c4e-8f4c-4f67-bfd5-eb444343c1ca/documents/c05c242e-a43b-444b-b60c-41231a15b396_a8b505c0-1567-4656-b3dc-68305a3fa822.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Cycloocta-1,5-diene",111-78-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38e29c4e-8f4c-4f67-bfd5-eb444343c1ca/documents/c05c242e-a43b-444b-b60c-41231a15b396_a8b505c0-1567-4656-b3dc-68305a3fa822.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,675 mg/m3,,rat "Cycloocta-1,5-diene",111-78-4,"In a study according to OECD TG 401 (1981) the test item was applied once to 4 dose groups of rats (5 male and 5 female Wistar rats per dose group) in doses of 1250, 1580, 1990, 2510 mg/kg bw undiluted. The observation period was 14 days (Hüls AG 1983). 1,5 -Cyclooctadiene is of low to moderate acute toxicity with an oral LD50 (rat) of 1900 mg/kg bw. In a determination of the acute dermal toxicity on male and female rats it was found that the LD50 of the test item is greater than 10000 mg/kg. The treated animals showed signs of toxicity for up to 48 hours. There was no influence on the increase in body weight. Dissection at the end of the experiment revealed no evidence of macroscopically detectable organ changes (Hüls AG 1983). Three groups of 6 male rats each were exposed nose-only for a single, 4 hour period to vapors of the test item in air at chamber vapor concentrations of 1400, 2700 or 4300 ppm. On an acute inhaltion basis, test item is considered slightly toxic (DuPont 1996). Summarized: 1,5 -Cyclooctadiene is of low to moderate acute toxicity with an oral LD50 (rat) of 1900 mg/kg bw (Hüls AG, 1983), a dermal LD50 (rat of > 10000 mg/kg bw and an approximate lethal concentration (ALC, rat, 4 h, vapour) of 12 -19 mg/L after inhalation exposure. The test item may be fatal if swallowed and enters airways. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38e29c4e-8f4c-4f67-bfd5-eb444343c1ca/documents/1180b316-4095-458e-8dd1-8ca7db28e31f_a8b505c0-1567-4656-b3dc-68305a3fa822.html,,,,,, "Cycloocta-1,5-diene",111-78-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38e29c4e-8f4c-4f67-bfd5-eb444343c1ca/documents/1180b316-4095-458e-8dd1-8ca7db28e31f_a8b505c0-1567-4656-b3dc-68305a3fa822.html,,oral,LD50,"1,900 mg/kg bw",adverse effect observed, "Cycloocta-1,5-diene",111-78-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38e29c4e-8f4c-4f67-bfd5-eb444343c1ca/documents/1180b316-4095-458e-8dd1-8ca7db28e31f_a8b505c0-1567-4656-b3dc-68305a3fa822.html,,dermal,LD50,"10,000 mg/kg bw",no adverse effect observed, Cyclooctane,292-64-8,"The test item showed low toxicity and the LD50 value was determined to be higher than 2000 mg/kg body weight after single oral administration in female rats (reference 7.2.1-1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The guideline study is of sufficient quality to address the endpoint. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e1667e8-ea5d-4ddf-97cc-3cdac851bc16/documents/a0c9ac68-e70c-471c-b796-136c6712b119_f73f2ad6-9144-4fac-984d-885c4fec7b63.html,,,,,, Cyclooctane,292-64-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e1667e8-ea5d-4ddf-97cc-3cdac851bc16/documents/a0c9ac68-e70c-471c-b796-136c6712b119_f73f2ad6-9144-4fac-984d-885c4fec7b63.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Cyclooctanone,502-49-8," Two publications considered of being not assignable were available dealing with acute toxicity of cyclooctanone (Caujolle and Caujolle, 1965; Caujolle et al. 1962). Based on limited reliability of the studies, cyclooctanone does not require classification for acute toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9de92c4c-a2a3-44ec-b6c3-2ddcb57e47ba/documents/1062c300-50ac-45ee-898d-f5b5bb25b162_49a1f3a5-a2c9-495d-a042-7cbb6e36701c.html,,,,,, Cyclooctanone,502-49-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9de92c4c-a2a3-44ec-b6c3-2ddcb57e47ba/documents/1062c300-50ac-45ee-898d-f5b5bb25b162_49a1f3a5-a2c9-495d-a042-7cbb6e36701c.html,,oral,LD50,"1,310 mg/kg bw",adverse effect observed, Cyclopentane,287-92-3, Inhalation NOAEC (Rat): 30000 mg/m3 (according to OECD TG 413) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7384a4a9-5b58-48c0-b9b5-32f0e954272b/documents/732f932e-c9c0-4758-b836-e771e2818433_3e6817c9-4cde-4325-a9ed-f6e7eb173e1f.html,,,,,, Cyclopentane,287-92-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7384a4a9-5b58-48c0-b9b5-32f0e954272b/documents/732f932e-c9c0-4758-b836-e771e2818433_3e6817c9-4cde-4325-a9ed-f6e7eb173e1f.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"30,000 mg/m3",,rat Cyclopentane,287-92-3, Acute Oral Toxicity: LD50>5000 mg/Kg in rats (OECD TG 401)   Acute Inhalation Toxicity: LC50>25300 mg/m3in rats (OECD TG 403) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7384a4a9-5b58-48c0-b9b5-32f0e954272b/documents/49aa543e-ae15-40f8-8930-ac39db4b345b_3e6817c9-4cde-4325-a9ed-f6e7eb173e1f.html,,,,,, Cyclopentane,287-92-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7384a4a9-5b58-48c0-b9b5-32f0e954272b/documents/49aa543e-ae15-40f8-8930-ac39db4b345b_3e6817c9-4cde-4325-a9ed-f6e7eb173e1f.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Cyclopentane,287-92-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7384a4a9-5b58-48c0-b9b5-32f0e954272b/documents/49aa543e-ae15-40f8-8930-ac39db4b345b_3e6817c9-4cde-4325-a9ed-f6e7eb173e1f.html,,inhalation,LC50,"> 25,300 mg/m3",no adverse effect observed, cyclopentyl methyl ether,5614-37-9,28 day oral toxicity study by gavage - NOAEL = 150 mg/kg/day;90 day oral toxicity study by gavage - NOAEL = 32 mg/kg/day;90 day inhalation study by whole body exposure - NOAEC = 840 mg/m3. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7cde109c-fded-47c4-b363-afe4912b3853/documents/79171041-efc8-454c-bfd5-cfb4897a276e_1c8f2ad5-5cd8-485c-b6a7-45828d6c342e.html,,,,,, cyclopentyl methyl ether,5614-37-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7cde109c-fded-47c4-b363-afe4912b3853/documents/79171041-efc8-454c-bfd5-cfb4897a276e_1c8f2ad5-5cd8-485c-b6a7-45828d6c342e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,32 mg/kg bw/day,,rat cyclopentyl methyl ether,5614-37-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7cde109c-fded-47c4-b363-afe4912b3853/documents/79171041-efc8-454c-bfd5-cfb4897a276e_1c8f2ad5-5cd8-485c-b6a7-45828d6c342e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,840 mg/m3,,rat cyclopentyl methyl ether,5614-37-9,"Acute toxicity, oral, (rat): 200 mg/kg bodyweight < LD50 < 2000 mg/kg bodyweight;Acute toxicity, inhalation (rat): 4h LC50 >21.5 mg/L;Acute toxicity, dermal (rat): LD50 > 2000 mg/kg bodyweight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cde109c-fded-47c4-b363-afe4912b3853/documents/70d69c18-1810-47cc-910a-adfacf787108_1c8f2ad5-5cd8-485c-b6a7-45828d6c342e.html,,,,,, cyclopentyl methyl ether,5614-37-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cde109c-fded-47c4-b363-afe4912b3853/documents/70d69c18-1810-47cc-910a-adfacf787108_1c8f2ad5-5cd8-485c-b6a7-45828d6c342e.html,,oral,LD50,200 mg/kg bw,adverse effect observed, cyclopentyl methyl ether,5614-37-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cde109c-fded-47c4-b363-afe4912b3853/documents/70d69c18-1810-47cc-910a-adfacf787108_1c8f2ad5-5cd8-485c-b6a7-45828d6c342e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, cyclopentyl methyl ether,5614-37-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cde109c-fded-47c4-b363-afe4912b3853/documents/70d69c18-1810-47cc-910a-adfacf787108_1c8f2ad5-5cd8-485c-b6a7-45828d6c342e.html,,inhalation,LC50,"21,500 mg/m3",no adverse effect observed, "methyl [(1R,2S)-3-oxo-2-pentylcyclopentyl]acetate",93452-03-0,"A 90-d dietary study by oral route has been performed on the test material (OECD 408, GLP, read-across, Rel.2). The maximum dose level was 100 mg/kg bw/day and was limited by palatability. An OECD 422 combined repeat dose and reproductive screening study was performed (OECD 422, GLP, read-across, Rel.2) using the oral gavage dose route and the maximum dose level with no adverse effects was 1000 mg/kg bw/day. This study was selected to use for the calculation of the DNEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a563fef8-2e87-4957-9c59-47368da66933/documents/IUC5-d9fe3dc2-7857-4f9a-924b-60ecfb83375f_5341feb9-2d22-40e5-8981-67a6e5740101.html,,,,,, "methyl [(1R,2S)-3-oxo-2-pentylcyclopentyl]acetate",93452-03-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a563fef8-2e87-4957-9c59-47368da66933/documents/IUC5-d9fe3dc2-7857-4f9a-924b-60ecfb83375f_5341feb9-2d22-40e5-8981-67a6e5740101.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "methyl [(1R,2S)-3-oxo-2-pentylcyclopentyl]acetate",93452-03-0,"5000 mg/kg bw < Oral LD50 < 10000 mg/kg bw (OECD 401, WoE, Rel.2, limit test in rats)Dermal LD50 > 5000 mg/kg (U.S.- FHSA, K, Rel. 2, limit test in rabbits)Inhalation LC50 > 4.96 mg/L (OECD 403, K, Rel.2, limit test in rats) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a563fef8-2e87-4957-9c59-47368da66933/documents/IUC5-444a3051-2184-4ca6-8bac-db0f152e52ef_5341feb9-2d22-40e5-8981-67a6e5740101.html,,,,,, "methyl [(1R,2S)-3-oxo-2-pentylcyclopentyl]acetate",93452-03-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a563fef8-2e87-4957-9c59-47368da66933/documents/IUC5-444a3051-2184-4ca6-8bac-db0f152e52ef_5341feb9-2d22-40e5-8981-67a6e5740101.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "methyl [(1R,2S)-3-oxo-2-pentylcyclopentyl]acetate",93452-03-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a563fef8-2e87-4957-9c59-47368da66933/documents/IUC5-444a3051-2184-4ca6-8bac-db0f152e52ef_5341feb9-2d22-40e5-8981-67a6e5740101.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "methyl [(1R,2S)-3-oxo-2-pentylcyclopentyl]acetate",93452-03-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a563fef8-2e87-4957-9c59-47368da66933/documents/IUC5-444a3051-2184-4ca6-8bac-db0f152e52ef_5341feb9-2d22-40e5-8981-67a6e5740101.html,,inhalation,LC50,"4,930 mg/m3",no adverse effect observed, cis-2- Pentylcyclopentanol,157357-30-7,"Repeated dose toxicity oral (based on an analogue substance): NOAEL = 683 mg/kg bw/day in female rats; NOAEL = 704 mg/kg bw/day in male rats (OECD 422, K, rel. 1, read-across). Absence of significant effects that could be considered to be adverse at the highest dose tested and below. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dfe256a6-c94f-4feb-81fd-1d894e64dd76/documents/66c0ab1c-ce68-4035-8e6a-e7f992084889_03e71acd-7384-4672-a88e-8deb1a1f4e70.html,,,,,, cis-2- Pentylcyclopentanol,157357-30-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dfe256a6-c94f-4feb-81fd-1d894e64dd76/documents/66c0ab1c-ce68-4035-8e6a-e7f992084889_03e71acd-7384-4672-a88e-8deb1a1f4e70.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,683 mg/kg bw/day,,rat cis-2- Pentylcyclopentanol,157357-30-7,"Acute toxicity: oral: LD50 > 2000 mg/kg bw (OECD 423 in rats, K, rel.1);Acute toxicity: dermal: LD50 > 2000 mg/kg bw (OECD 402 in rabbits, read-across, K, rel. 1);Acute toxicity: inhalation: waiver. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfe256a6-c94f-4feb-81fd-1d894e64dd76/documents/d213bbc3-f505-4460-965a-44e509eeb6a7_03e71acd-7384-4672-a88e-8deb1a1f4e70.html,,,,,, cis-2- Pentylcyclopentanol,157357-30-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfe256a6-c94f-4feb-81fd-1d894e64dd76/documents/d213bbc3-f505-4460-965a-44e509eeb6a7_03e71acd-7384-4672-a88e-8deb1a1f4e70.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, cis-2- Pentylcyclopentanol,157357-30-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfe256a6-c94f-4feb-81fd-1d894e64dd76/documents/d213bbc3-f505-4460-965a-44e509eeb6a7_03e71acd-7384-4672-a88e-8deb1a1f4e70.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Cyclopentene,142-29-0," Acute Oral Toxicity A range-finding toxicity study was conducted with Wistar rats using a variety of substances, including the test substance, cyclopentene. The test substance was administered to Wistar rats as a single oral LD50 dose via oral gavage. Cyclopentene was shown to have a single dose LD50 in rats of 1656 mg/kg. Acute Inhalation Toxicity The Kimmerle 1975 study was an investigation evaluating the acute, subacute and subchronic inhalation toxicity of the test substance, Cylopentene.After a 4 -hour exposure to about 4000 ppm or less of cyclopentene, there were no observable toxic symptoms, but those animals exposed to higher concentrations, developed an irritation of the mucosa of the upper airways. This was seen in both males and females. It can be concluded that the LC50 after a 4 -hour exposure to cyclopentene was > 22.9 mg/L air in male and female rats. Acute Dermal Toxicity A range-finding toxicity study was conducted with New Zealand white rabbits using a variety of substances, including the test substance, cyclopentene. After a 24 -hour exposure to cyclopentene was shown to have a single skin penetration LD50 of 1231 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e95c9f95-836f-493e-95c2-c2293dbbfb42/documents/a7a97635-2038-4650-a6cf-463d055435b2_6c1a6058-4542-4254-be20-c8b9798cc070.html,,,,,, Cyclopentene,142-29-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e95c9f95-836f-493e-95c2-c2293dbbfb42/documents/a7a97635-2038-4650-a6cf-463d055435b2_6c1a6058-4542-4254-be20-c8b9798cc070.html,,oral,LD50,"1,656 mg/kg bw",adverse effect observed, Cyclopentene,142-29-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e95c9f95-836f-493e-95c2-c2293dbbfb42/documents/a7a97635-2038-4650-a6cf-463d055435b2_6c1a6058-4542-4254-be20-c8b9798cc070.html,,dermal,LD50,"1,231 mg/kg bw",no adverse effect observed, Cyclopentene,142-29-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e95c9f95-836f-493e-95c2-c2293dbbfb42/documents/a7a97635-2038-4650-a6cf-463d055435b2_6c1a6058-4542-4254-be20-c8b9798cc070.html,,inhalation,LC50,"22,564.05 mg/m3",no adverse effect observed, (3Z)-hex-3-en-1-yl cyclopropanecarboxylate,188570-78-7,"A 7 day repeated dose toxicity range finding study is available. At 1000 mg/kg bw animals had to be killed due to excessive signs to treatment on day 3 of treatment. Effects seen were underactive behaviour, shallow breathing and unsteady/prostrate posture. Animals also showed body weight loss and low food consumption. At 400 mg/kg bw animals showed underactivity and low food consumption. At 150 mg/kg bw no clinical signs, body weight effects or macroscoping findings were seen. A subsequent 28-day study was not (yet) performed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/453e740e-5991-4fdb-a401-07714bfb1f8f/documents/IUC5-fac695e8-842e-4570-bf72-4fccb927ac52_434cebef-1706-45d8-ab53-56eddf28cfc7.html,,,,,, (3Z)-hex-3-en-1-yl cyclopropanecarboxylate,188570-78-7,"A study according to OECD guideline 401 was performed to assess the acute oral toxicity of Montaverdi to the rat. As there was no mortality in any of the five females and two deaths in the group of five males (2/10 total mortality), the results of the study demonstrate that the acute median lethal oral dose (LD50) to rats of Montaverdi is greater than 2000 mg/kg bodyweight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/453e740e-5991-4fdb-a401-07714bfb1f8f/documents/IUC5-a33da1ca-9a54-4805-bd26-516ed9e1a191_434cebef-1706-45d8-ab53-56eddf28cfc7.html,,,,,, (3Z)-hex-3-en-1-yl cyclopropanecarboxylate,188570-78-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/453e740e-5991-4fdb-a401-07714bfb1f8f/documents/IUC5-a33da1ca-9a54-4805-bd26-516ed9e1a191_434cebef-1706-45d8-ab53-56eddf28cfc7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "[(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3-(cyclopropanecarbonyloxy)-6,12-dihydroxy-4,6a,12btrimethyl-11-oxo-9-(pyridin-3-yl)-1,2,3,4,4a,5,6,6a,12a,12b-decahydro-11H,12Hbenzo[f]pyrano[4,3-b]chromen-4-yl]methylcyclopropanecarboxylate",915972-17-7," The repeated dose toxicity of the test substance was investigated in several short-term and long-term oral-feeding studies in rats, mice and dogs as well as one 28d dermal study in rats. SHORT-TERM TOXICITY The short-term toxicity of Afidopyropen was investigated in 28- and 90-day oral feeding studies in rats, mice and dogs as well as in a 1-year feeding study in dogs. Additionally, a 28-day repeated dose dermal exposure study in rats was conducted. Administration of Afidopyropen to rats, mice and dogs by the oral route resulted in organ weight increases and histopathological findings. The principal target organ in all studies was the liver, as indicated by organ weight changes and associated histopathological changes at high doses (lipid deposits). In the F344 rat, the uterus (weight decrease) and the heart (vacuolar changes) were additional target organs at high doses. Findings at the LOAEL were typically only mildly adverse (slight changes in clinical chemistry, organ weight changes without severe histopathological findings). At higher doses, particularly with the dog and mice, treatment was not well tolerated, with severe effects on clinical signs and mortality / moribundity. Dermal administration of Afidopyropen to rats for 28-days did not result in any treatment-related changes up to the limit dose of 1000 mg/kg. Based on the findings in short-term studies, a relevant overall short-term NOAEL of 15 mg/kg bw/d is proposed. This value is derived from the NOAEL in the 90-day dog study. CHRONIC TOXICITY The chronic toxicity of the test substance was evaluated in long-term studies in rats and mice. In a chronic toxicity study with rats, Afidopyropen was administered to groups of Fischer rats at dietary concentrations of 0, 75, 150, 300 or 1000 ppm for a period of 1 year. There were no treatment-related effects reported for mortality, detailed and general observations, organ weights, functional examination, ophthalmology, feed efficiency, urinalysis, or body weight ratio in any of the treated groups. At the 1000 ppm dietary level, there were treatment-related decreases in body weights and food consumption of females, and alterations in hematology and biochemistry in both sexes, gross changes in the liver of one female and an increase in the incidence of fatty vacuolar changes in both the liver and the heart of females. Based on the results of this study, the no adverse effect level (NOAEL) was 300 ppm (14.6 mg/kg/day) in males and 150 ppm (8.9 mg/kg/day) in females. In a second supplemental chronic toxicity study with rats, Afidopyropen was administered to groups of Fischer rats at dietary concentrations of 0, 1000 or 3000 ppm for a period of 1 year. There were no treatment-related clinical signs or neurobehavioral effects. Toxicity was observed in both sexes at both doses resulting in effects on bodyweight, food consumption, hematology, clinical chemistry, urinalysis, organ weights and gross pathology. Histopathological changes were observed in the liver, heart and pituitary of females. The NOAEL for all effects observed in this study was established in a prior chronic rat study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5ff4448-3f01-424d-8e55-fbd7cd6f1fc4/documents/280a4ac3-34b1-4b59-b538-5cb4be04ae07_96b39587-a921-4493-aa33-f64d581e06c8.html,,,,,, "[(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3-(cyclopropanecarbonyloxy)-6,12-dihydroxy-4,6a,12btrimethyl-11-oxo-9-(pyridin-3-yl)-1,2,3,4,4a,5,6,6a,12a,12b-decahydro-11H,12Hbenzo[f]pyrano[4,3-b]chromen-4-yl]methylcyclopropanecarboxylate",915972-17-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5ff4448-3f01-424d-8e55-fbd7cd6f1fc4/documents/280a4ac3-34b1-4b59-b538-5cb4be04ae07_96b39587-a921-4493-aa33-f64d581e06c8.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "[(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3-(cyclopropanecarbonyloxy)-6,12-dihydroxy-4,6a,12btrimethyl-11-oxo-9-(pyridin-3-yl)-1,2,3,4,4a,5,6,6a,12a,12b-decahydro-11H,12Hbenzo[f]pyrano[4,3-b]chromen-4-yl]methylcyclopropanecarboxylate",915972-17-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5ff4448-3f01-424d-8e55-fbd7cd6f1fc4/documents/280a4ac3-34b1-4b59-b538-5cb4be04ae07_96b39587-a921-4493-aa33-f64d581e06c8.html,Chronic toxicity – systemic effects,oral,NOAEL,8.9 mg/kg bw/day,,rat "[(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3-(cyclopropanecarbonyloxy)-6,12-dihydroxy-4,6a,12btrimethyl-11-oxo-9-(pyridin-3-yl)-1,2,3,4,4a,5,6,6a,12a,12b-decahydro-11H,12Hbenzo[f]pyrano[4,3-b]chromen-4-yl]methylcyclopropanecarboxylate",915972-17-7," Acute oral toxicity The LD50 of the acute oral toxicity was determined to be > 2000 mg/kg bw.   Acute dermal toxicity Based on the absence of mortality, the acute dermal LD50 was determined to be > 2000 mg/kg bw.   Acute inhalation toxicity In the acute inhalation toxicity test, no mortality was observed, therefore the LC50 was found to be > 5.48 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5ff4448-3f01-424d-8e55-fbd7cd6f1fc4/documents/f736915d-7ed5-4477-a6ce-16ade6e0282a_96b39587-a921-4493-aa33-f64d581e06c8.html,,,,,, "[(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3-(cyclopropanecarbonyloxy)-6,12-dihydroxy-4,6a,12btrimethyl-11-oxo-9-(pyridin-3-yl)-1,2,3,4,4a,5,6,6a,12a,12b-decahydro-11H,12Hbenzo[f]pyrano[4,3-b]chromen-4-yl]methylcyclopropanecarboxylate",915972-17-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5ff4448-3f01-424d-8e55-fbd7cd6f1fc4/documents/f736915d-7ed5-4477-a6ce-16ade6e0282a_96b39587-a921-4493-aa33-f64d581e06c8.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "[(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3-(cyclopropanecarbonyloxy)-6,12-dihydroxy-4,6a,12btrimethyl-11-oxo-9-(pyridin-3-yl)-1,2,3,4,4a,5,6,6a,12a,12b-decahydro-11H,12Hbenzo[f]pyrano[4,3-b]chromen-4-yl]methylcyclopropanecarboxylate",915972-17-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5ff4448-3f01-424d-8e55-fbd7cd6f1fc4/documents/f736915d-7ed5-4477-a6ce-16ade6e0282a_96b39587-a921-4493-aa33-f64d581e06c8.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "[(3S,4R,4aR,6S,6aS,12R,12aS,12bS)-3-(cyclopropanecarbonyloxy)-6,12-dihydroxy-4,6a,12btrimethyl-11-oxo-9-(pyridin-3-yl)-1,2,3,4,4a,5,6,6a,12a,12b-decahydro-11H,12Hbenzo[f]pyrano[4,3-b]chromen-4-yl]methylcyclopropanecarboxylate",915972-17-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5ff4448-3f01-424d-8e55-fbd7cd6f1fc4/documents/f736915d-7ed5-4477-a6ce-16ade6e0282a_96b39587-a921-4493-aa33-f64d581e06c8.html,,inhalation,discriminating conc.,"5,480 mg/m3",no adverse effect observed, "ETHYL (1R,2S)-1-AMINO-2-ETHENYLCYCLOPROPANECARBOXYLATE SULPHATE (2:1)",1173807-85-6,"The study performed was an acute oral toxicity test to the rat, following an up-and-down procedure in accordance with the OECD guideline n°425, EPA Health Effects Test Guidelines OPPTS 870.1100 and a guideline from Japanese Ministry of Agriculture, Forestry and Fisheries (Test Data for Registration of Agricultural Chemicals, Acute oral toxicity (2-1-1), 12 Nousan No 8147, Agricultural Production Bureau, November 24, 2000.). The acute median lethal oral dose (LD50) of JNJ-31052047-ABI to rats was demonstrated to be 2000 mg/kg bodyweight. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ca6507d-a630-4a4b-844b-e3e1978058aa/documents/IUC5-502de6d9-6ae1-434f-9558-093a7745ae71_3084edbb-7866-40b9-8838-80a1c4d346a2.html,,,,,, "ETHYL (1R,2S)-1-AMINO-2-ETHENYLCYCLOPROPANECARBOXYLATE SULPHATE (2:1)",1173807-85-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ca6507d-a630-4a4b-844b-e3e1978058aa/documents/IUC5-502de6d9-6ae1-434f-9558-093a7745ae71_3084edbb-7866-40b9-8838-80a1c4d346a2.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "2-[1-(3,3-dimethylcyclohexyl)ethoxy]-2-methylpropyl cyclopropanecarboxylate",477218-42-1," Oral: NOAEL (rat): 30 mg/kg body weight per day ; male/female, OECD TG 407, 2004 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa9be27a-a107-473b-bb09-00feca20d90b/documents/d9349633-69d5-4130-899b-a00d9aabe4d6_f3930559-cbc8-4010-a15c-f1b9b55ad367.html,,,,,, "2-[1-(3,3-dimethylcyclohexyl)ethoxy]-2-methylpropyl cyclopropanecarboxylate",477218-42-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa9be27a-a107-473b-bb09-00feca20d90b/documents/d9349633-69d5-4130-899b-a00d9aabe4d6_f3930559-cbc8-4010-a15c-f1b9b55ad367.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "2-[1-(3,3-dimethylcyclohexyl)ethoxy]-2-methylpropyl cyclopropanecarboxylate",477218-42-1," Oral: measured LD50 > 2000 mg/kg bw and the estimated LD50 cut-off can be considered to be > 5000 mg/kg bw, female rat, OECD TG 423, 2004 Acute Inhalation toxicity: measured LC50 > 5.1 mg/L (mean achieved concentration), OECD TG 403, 2015 Dermal: measured LD50 > 2000 mg/kg bw and the estimated LD50 cut-off value was considered to be > 5000 mg/kg bw, male/female rat, OECD TG 402, 2004 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa9be27a-a107-473b-bb09-00feca20d90b/documents/31c31836-95df-41d6-8c92-4e64ceb9953d_f3930559-cbc8-4010-a15c-f1b9b55ad367.html,,,,,, "2-[1-(3,3-dimethylcyclohexyl)ethoxy]-2-methylpropyl cyclopropanecarboxylate",477218-42-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa9be27a-a107-473b-bb09-00feca20d90b/documents/31c31836-95df-41d6-8c92-4e64ceb9953d_f3930559-cbc8-4010-a15c-f1b9b55ad367.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-[1-(3,3-dimethylcyclohexyl)ethoxy]-2-methylpropyl cyclopropanecarboxylate",477218-42-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa9be27a-a107-473b-bb09-00feca20d90b/documents/31c31836-95df-41d6-8c92-4e64ceb9953d_f3930559-cbc8-4010-a15c-f1b9b55ad367.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-[1-(3,3-dimethylcyclohexyl)ethoxy]-2-methylpropyl cyclopropanecarboxylate",477218-42-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa9be27a-a107-473b-bb09-00feca20d90b/documents/31c31836-95df-41d6-8c92-4e64ceb9953d_f3930559-cbc8-4010-a15c-f1b9b55ad367.html,,inhalation,LC50,"5,100 mg/m3",no adverse effect observed, "(1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL",198404-98-7," NOAEL = 100 mg/kg/day for males or females (OECD 407, GLP, K rel. 1) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb3446e7-257a-4a39-8310-2989be2a704b/documents/df96e577-a759-4d8f-aee6-2ad6645899b2_ebc2a281-3e73-4a01-a9cb-f641bd730747.html,,,,,, "(1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL",198404-98-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb3446e7-257a-4a39-8310-2989be2a704b/documents/df96e577-a759-4d8f-aee6-2ad6645899b2_ebc2a281-3e73-4a01-a9cb-f641bd730747.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "(1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL",198404-98-7," Oral: Acute oral toxicity was assessed in a study similar to OECD Test Guideline 401 (OECD 401, Rel.1, Acute Oral Toxicity adopted February 24, 1987), resulting in a LD50 of greater than 2000 mg/kg body weight. No adverse effects noted in either males or females. Inhalation: No data Dermal: Acute dermal toxicity was assessed in a study similar to OECD Test Guideline 402 (OECD 402, Rel.1, Acute Dermal Toxicity adopted February 24, 1987), resulting in a LD50 of greater than 2000 mg/kg body weight. No adverse effects noted in either males or females. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb3446e7-257a-4a39-8310-2989be2a704b/documents/933158e4-5b5c-466c-a051-78c5e2749f62_ebc2a281-3e73-4a01-a9cb-f641bd730747.html,,,,,, "(1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL",198404-98-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb3446e7-257a-4a39-8310-2989be2a704b/documents/933158e4-5b5c-466c-a051-78c5e2749f62_ebc2a281-3e73-4a01-a9cb-f641bd730747.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(1-METHYL-2-(1,2,2-TRIMETHYLBICYCLO(3.1.0)-HEX-3-YLMETHYL)CYCLOPROPYL)METHANOL",198404-98-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb3446e7-257a-4a39-8310-2989be2a704b/documents/933158e4-5b5c-466c-a051-78c5e2749f62_ebc2a281-3e73-4a01-a9cb-f641bd730747.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Cytidine 3'-(dihydrogen phosphate),63-37-6," Weight of evidence: The oral sub-chronic NOAEL of the test item is deemed to be ca. 662 mg/kg bw/d (worst-case scenario), based on the available information from supporting analogue substances:   - Read-across from supporting substance (structural analogue or surrogate). Source: Short-term repeated dose toxicity study, method similar to OECD 407, GLP study. The NOAEL of the analogue substance citicoline was found to be 1500 mg/kg bw/day in rats, after 30-day oral administration (Romero et al. 1983). Based on the read-across approach, the NOAEL of the target substance is 993 mg/kg bw/day.   - Read-across from supporting substance (structural analogue or surrogate). Source: Sub-chronic oral toxicity study, method according to OECD 408, GLP study. The NOAEL of the analogue substance citicoline was found to be 1000 mg/kg bw/day in rats, after 90-day oral administration (Schauss et al. 2009). Based on the read-across approach, the NOAEL of the target substance is 662 mg/kg bw/day.   - Read-across from supporting substance (structural analogue or surrogate). Source: Chronic oral toxicity study, method similar to OECD 452, GLP study. The NOAEL of the analogue substance citicoline was found to be 1500 mg/kg bw/day in dogs, after 6-month oral administration (Romero et al. 1983). Based on the read-across approach, the NOAEL of the target substance is 993 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25fdb153-8ae5-4c9b-82d8-96bce0d3cd82/documents/17a30238-01e9-49a8-9fe9-eed366f661db_2dbbddcd-b327-4a96-b058-9c9881d65be2.html,,,,,, Cytidine 3'-(dihydrogen phosphate),63-37-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25fdb153-8ae5-4c9b-82d8-96bce0d3cd82/documents/17a30238-01e9-49a8-9fe9-eed366f661db_2dbbddcd-b327-4a96-b058-9c9881d65be2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,662 mg/kg bw/day,,rat Cytidine 3'-(dihydrogen phosphate),63-37-6," Acute toxicity: oral route. Weight of evidence:   - Read-across from analogue substance. Source: Method similar to OECD 423. GLP study. The oral LD50 of Citicoline was determined to be higher than 2000 mg/kg bw in rats (Schauss et al 2009). Based on the available information for the read-across approach, the target substance is deemed to have an LD50 higher than 1324 mg/kg bw. - Read-across from analogue substance. Source: Method similar to OECD 420. The LD50 of Citicoline is higher than 8000 mg/kg body weight by oral route in the rat (Grau et al. 1983). Based on the available information for the read-across approach, the target substance is deemed to have an LD50 higher than 5295 mg/kg bw. - Read-across from analogue substance. Source: Method similar to OECD 401. The LD50 of Citicoline is 18501 mg/kg body weight by oral route in male rats (Kanabayashi et al. 1980). Based on the available information for the read-across approach, the target substance is deemed to have an LD50 of 12245 mg/kg bw. - Read-across from analogue substance. Source: Method similar to OECD 420. The LD50 of Citicoline is higher than 8000 mg/kg body weight by oral route in the mice (Grau et al. 1983). Based on the available information for the read-across approach, the target substance is deemed to have an LD50 higher than 5295 mg/kg bw. - Read-across from analogue substance. Source: Method similar to OECD 401. The LD50 of Citicoline is 27142 mg/kg body weight by oral route in male mice (Kanabayashi et al. 1980). Based on the available information for the read-across approach, the target substance is deemed to have an LD50 of 17964 mg/kg bw. - Read-across from analogue substance. Source: Method similar to OECD 401. The LD0 of Citicoline is 14000 mg/kg body weight by oral route in mice (Agut et al. 1983). Based on the available information for the read-across approach, the target substance is deemed to have an LD0 of 9266 mg/kg bw.   Based on the available information for the read-across approach and in a weight of evidence scenario, the target substance Cytidine 3'-(dihydrogen phosphate) has an LD50 higher than 2000 mg/kg bw in rats and mice. Acute toxicity: dermal route - Key study: OECD 402 and EU B.3. GLP study. The dermal LD50 of Cytidine 3'-(dihydrogen phosphate) in rats is greater than 2000 mg/kg bw. Acute toxicity: inhalation route - Data waiving (other justification): According to Regulation (EC) No. 1907/2006, Annex VIII, 8.5.3, column 2, the acute toxicity by inhalation route is not required, as both oral and dermal studies are available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25fdb153-8ae5-4c9b-82d8-96bce0d3cd82/documents/a0f0eefa-5148-40ff-9212-7652d3462613_2dbbddcd-b327-4a96-b058-9c9881d65be2.html,,,,,, Cytidine 3'-(dihydrogen phosphate),63-37-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25fdb153-8ae5-4c9b-82d8-96bce0d3cd82/documents/a0f0eefa-5148-40ff-9212-7652d3462613_2dbbddcd-b327-4a96-b058-9c9881d65be2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Cytidine 3'-(dihydrogen phosphate),63-37-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25fdb153-8ae5-4c9b-82d8-96bce0d3cd82/documents/a0f0eefa-5148-40ff-9212-7652d3462613_2dbbddcd-b327-4a96-b058-9c9881d65be2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, D-(-)-α-phenylglycine,875-74-1,"oral LD50 (rat, male, female) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee13ccbf-323b-4d11-85b6-6b6b9817d8fe/documents/IUC5-867b9542-1bb3-43a0-a8be-ca01751a726e_30c8f202-34a7-43ee-8d6a-cd21b82bd133.html,,,,,, "D,L-DIETHYL TARTRATE",57968-71-5," Acute toxicity: oral: LD50 > 2000 mg/kg bw (OECD 423, GLP, Key, rel.1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acdb5af2-11db-4692-ab47-c608e700b59f/documents/3077f889-1c4c-42a0-aee1-47c29a4a285e_15edc09e-dce5-409e-ba29-ff39a98b31ce.html,,,,,, "D,L-DIETHYL TARTRATE",57968-71-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acdb5af2-11db-4692-ab47-c608e700b59f/documents/3077f889-1c4c-42a0-aee1-47c29a4a285e_15edc09e-dce5-409e-ba29-ff39a98b31ce.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, D-2-hydroxy-2-phenylacetic acid,17199-29-0,"LD50 (oral,rat): ca. 5000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/975b6fd9-7761-4d9a-887a-24743bef4b06/documents/IUC5-dd5964a9-0d11-4baf-8908-89ec015e291f_aa264c68-23d4-4924-9ddc-eb672c1ccb6d.html,,,,,, D-2-hydroxy-2-phenylacetic acid,17199-29-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/975b6fd9-7761-4d9a-887a-24743bef4b06/documents/IUC5-dd5964a9-0d11-4baf-8908-89ec015e291f_aa264c68-23d4-4924-9ddc-eb672c1ccb6d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Dapsone,80-08-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The whole database is excellent, because dapsone has a dual use as an industrial chemical and a pharmaceutical. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35122c53-56a1-4d41-8fbf-aa3f94fee4ee/documents/IUC5-5d809856-9b6d-43c3-ae6f-aa4792bbb05f_112bac22-c1c6-4bc0-8329-5130eefa5f16.html,,,,,, Dapsone,80-08-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35122c53-56a1-4d41-8fbf-aa3f94fee4ee/documents/IUC5-5d809856-9b6d-43c3-ae6f-aa4792bbb05f_112bac22-c1c6-4bc0-8329-5130eefa5f16.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,3 mg/kg bw/day,,rat Dapsone,80-08-0, Based on available data median lethal dose through oral and dermal route for dapsone is >250 and >2000 mg/kg bw respectively. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35122c53-56a1-4d41-8fbf-aa3f94fee4ee/documents/IUC5-0ca95779-7210-4fe5-9989-f0f489233cb2_112bac22-c1c6-4bc0-8329-5130eefa5f16.html,,,,,, Dapsone,80-08-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35122c53-56a1-4d41-8fbf-aa3f94fee4ee/documents/IUC5-0ca95779-7210-4fe5-9989-f0f489233cb2_112bac22-c1c6-4bc0-8329-5130eefa5f16.html,,oral,LD50,> 250 mg/kg bw,adverse effect observed, Dapsone,80-08-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35122c53-56a1-4d41-8fbf-aa3f94fee4ee/documents/IUC5-0ca95779-7210-4fe5-9989-f0f489233cb2_112bac22-c1c6-4bc0-8329-5130eefa5f16.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, D-cellobiose,528-50-7," In a GLP-compliant study according to OECD TG 408 in rats, cellobiose administered via drinking water did not induce any adverse effects. The experimental no-observed-adverse-effect level (NOAEL) was equal to or greater than 10% Cellobiose in drinking water (equivalent to ~ 6852 and ~ 8043 mg Cellobiose per kg body weight for males and females, respectively). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7d54376-6cec-45ec-a5b2-8b5d4a9c0065/documents/9b57bd70-c989-4763-a8d0-67de4a5de80e_c0b8c9a8-4d4c-4a72-a261-9bae95886446.html,,,,,, D-cellobiose,528-50-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7d54376-6cec-45ec-a5b2-8b5d4a9c0065/documents/9b57bd70-c989-4763-a8d0-67de4a5de80e_c0b8c9a8-4d4c-4a72-a261-9bae95886446.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"6,582 mg/kg bw/day",,rat D-cellobiose,528-50-7,"A 90-day repeated dose drinking water study in rats is available, in which no adverse effects were observed up to 6852 mg Cellobiose per kg body weight. From this study, it can be concluded that an acute oral toxicity study with a single dose of max. 5000 mg Cellobiose per kg body weight will also not induce any adverse effects. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7d54376-6cec-45ec-a5b2-8b5d4a9c0065/documents/6283c019-00e9-45d8-9329-e770ecfc84a7_c0b8c9a8-4d4c-4a72-a261-9bae95886446.html,,,,,, D-cellobiose,528-50-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7d54376-6cec-45ec-a5b2-8b5d4a9c0065/documents/6283c019-00e9-45d8-9329-e770ecfc84a7_c0b8c9a8-4d4c-4a72-a261-9bae95886446.html,,oral,LD0,"> 6,852 mg/kg bw",no adverse effect observed, dec-1-en-4-yne,24948-66-1," Oral: LD50 > 300 - < 2000 mg/kg bw, female rat, OECD TG 420, 2018 Inhalation: LC50 (male/female): > 4.90 (C.I. – ) mg/L, OECD TG 403, 2018 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e529858-565b-4663-9544-a4b918054e74/documents/00691326-870c-4e6d-af5a-54dbd236fe4b_5f5b411c-5eb8-493a-9403-972c197e72af.html,,,,,, dec-1-en-4-yne,24948-66-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e529858-565b-4663-9544-a4b918054e74/documents/00691326-870c-4e6d-af5a-54dbd236fe4b_5f5b411c-5eb8-493a-9403-972c197e72af.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, dec-1-en-4-yne,24948-66-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e529858-565b-4663-9544-a4b918054e74/documents/00691326-870c-4e6d-af5a-54dbd236fe4b_5f5b411c-5eb8-493a-9403-972c197e72af.html,,inhalation,discriminating conc.,"4,900 mg/m3",adverse effect observed, "Dec-1-ene, trimers, hydrogenated",157707-86-3,"Three read-across 28-day oral exposure studies (OECD 407) and three 90-day oral exposure studies (OECD 408/OECD 415) were identified either within category or from a structural analogue. There were no key dermal or inhalation repeated dose studies identified.Overall, the 28-day exposure studies found no toxicity when the respective poly alpha olefins were administered orally. Results were as follows.• The NOAEL is 6245 mg/kg/day in male rats and 6771 mg/kg/day in female rats for the 28-day oral repeated dose study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1-dodecene dimer with 1-decene, hydrogenated.• The NOAEL is 1000 mg/kg/day in male and female rats for the 28-day oral repeated dose study from 1 -dodecene, trimer.For the 90-day oral exposure studies, results were as follows.• The NOAEL is 4145.4 mg/kg bw in male rats and 4619.9 mg/kg bw in female rats for the 90-day exposure study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg bw in male and female rats for the 91-day exposure study from 1-decene, homopolymer, hydrogenated.• The NOAEL is 1000 mg/kg bw in male and female rats for the 90-day one-generation reproduction study with subchronic toxicity from 1 -dodecene, trimer. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76f40ebf-5f48-4bb8-b3a9-cf0711138b30/documents/99e8738b-e983-416f-a736-01b102ebd53d_a60a8f38-4d87-49b6-8f97-5866afb3e4de.html,,,,,, "Dec-1-ene, trimers, hydrogenated",157707-86-3,"One key acute oral toxicity studies (16 CFR 1500) and one key acute dermal toxicity study (OECD 402) were identified. Additional read-across studies were identified for numerous poly alpha olefins that showed similar acute oral and dermal toxicity results. Eight key acute inhalation studies (OECD 403) were identified for poly alpha olefins; four of which were for dec-1-ene, dimers, hydrogenated. • The oral LD50 was > 5000 mg/kg bw in male and female rats for dec-1-ene, dimers, hydrogenated; 1-dodecene dimer with 1-decene, hydrogenated; 1-decene trimer, hydrogenated and tetramers; 1-decene, homopolymer, hydrogenated; 1 -dodecene, trimer; and 1 -dodcene, polymer with 1 -decene.• The oral LD50 was > 2000 mg/kg bw in male and female rats for decene trimer hydrogenated.• The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits for dec-1-ene, dimers, hydrogenated.• The dermal LD50 was > 2000 mg/kg/bw in male and female rats for both 1 -dodecene dimer with 1 -decene, hydrogenated; 1 -dodecene dimer with 1 -decene, hydrogenated;1 -dodecene, trimer; and 1 -dodecene, polymer with 1 -decene. • The inhalation LC50 values for dec-1 -ene, dimers, hydrogenated in male and female rats were all reported as < 5.0 mg/L.• Dec-1-ene, dimers, hydrogenated is classified for aspiration toxicity based on its kinematic viscosity at 40°C. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76f40ebf-5f48-4bb8-b3a9-cf0711138b30/documents/52bb3c38-3146-45ac-ae60-fd9d5f38ea66_a60a8f38-4d87-49b6-8f97-5866afb3e4de.html,,,,,, dec-9-en-2-one,35194-30-0,"Repeated dose toxicity, oral: NOEL > 1000 mg/kg bw/day, male and female rats (OECD 407 - gavage, GLP, Rel.1) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The key study is GLP-compliant and of high quality (Klimisch score = 1). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9610e84-28b3-4427-92f1-223cbeab5145/documents/e46dc416-dad0-405e-99a4-3f44cadf9907_4f5b22a5-150c-4f57-8bec-b549eef713b0.html,,,,,, dec-9-en-2-one,35194-30-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9610e84-28b3-4427-92f1-223cbeab5145/documents/e46dc416-dad0-405e-99a4-3f44cadf9907_4f5b22a5-150c-4f57-8bec-b549eef713b0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat dec-9-en-2-one,35194-30-0," Oral LD50 > 2000 mg/kg bw (OECD 423, K, Rel.1, class method in rats) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9610e84-28b3-4427-92f1-223cbeab5145/documents/cfb85a58-3ac4-417c-a87b-3f966d70023b_4f5b22a5-150c-4f57-8bec-b549eef713b0.html,,,,,, dec-9-en-2-one,35194-30-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9610e84-28b3-4427-92f1-223cbeab5145/documents/cfb85a58-3ac4-417c-a87b-3f966d70023b_4f5b22a5-150c-4f57-8bec-b549eef713b0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, decachlorotetrasilane,13763-19-4," No data are available for the repeated dose oral toxicity of decachlorotetrasilane, therefore good quality data for the precipitated hydrolysis product, synthetic amorphous silica (SAS) have been read-across to address the potential for systemic toxicity. In a repeat dose 90-day oral toxicity study (Kim et al., 2014) with Sprague-Dawley rats, two forms of synthetic amorphous silica (SAS and NM-202; differing in particle size and specific surface area) were administered (vehicle: water) by oral gavage for 90 consecutive days at a dose of 500, 1000 or 2000 mg/kg bw/day (10 animals/sex/group). The particles were described as either 20 or 100 nm in diameter. Extra animals were included in the control (received water only) and highest dose groups to allow for a two-week post-exposure recovery period. Observations were made according to OECD TG 408. For 20 and 100 nm silica samples the findings were sporadic and without a dose-response, so were concluded by the study authors not to be treatment-related. The NOAEL for both particle sizes was therefore concluded to be ≥2000 mg/kg bw/day. For local effects a good quality study on hydrogen chloride is available. In a 90-day repeated dose inhalation study in rats and mice (Toxigenics, 1983), 31 males and 21 females of each species/strain were exposed to test concentrations of 0, 10, 20 and 50 ppm hydrogen chloride gas (HCl). Treatment was whole-body exposure for six hour per day, 5 days per week. The No Observed Adverse Effect Concentration (NOAEC) for systemic effects was determined to be 20 ppm (approximately 30 mg/m3) based on decreased body weight following exposure to 50 ppm. No NOAEC for local effects was established as irritant/corrosive effects were observed at all dose levels tested. No suitable dermal data are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b350956-6f03-45d9-bcc4-ac08321651b5/documents/bae582fe-f223-405b-a36f-2e99d1e7c6db_a61b8315-ea31-486a-84cb-c686f5a650ef.html,,,,,, decachlorotetrasilane,13763-19-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b350956-6f03-45d9-bcc4-ac08321651b5/documents/bae582fe-f223-405b-a36f-2e99d1e7c6db_a61b8315-ea31-486a-84cb-c686f5a650ef.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,000 mg/kg bw/day",,rat decachlorotetrasilane,13763-19-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b350956-6f03-45d9-bcc4-ac08321651b5/documents/bae582fe-f223-405b-a36f-2e99d1e7c6db_a61b8315-ea31-486a-84cb-c686f5a650ef.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 mg/m3,adverse effect observed,mouse decachlorotetrasilane,13763-19-4," In accordance with Column 2 of REACH Annex VIII, the acute oral toxicity study (required in Section 8.5.1) and an acute inhalation or dermal study (required in Section 8.5.2) do not need to be conducted as the substance is classified as corrosive to skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b350956-6f03-45d9-bcc4-ac08321651b5/documents/c6b9c7ec-b731-423a-b3b0-e327ede8a71f_a61b8315-ea31-486a-84cb-c686f5a650ef.html,,,,,, Decahydronaphthalene,91-17-8," Subacute studies on oral repeated dose toxicity in rats are available. Subcaute and subchronic repeated dose toxicity studies in rats, mice, dogs and guinea pigs with inhalation exposure to decahydronaphthalene are available (see below ""Additional information""). No data available on repeated dermal exposure with the test item. A data waiver is claimed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad5bc64b-ad90-4522-9946-7af15a021d6f/documents/IUC5-b4271866-6b2b-410f-b200-77bb73bf274a_65ec955f-1126-4cb9-8a6d-a3303a807267.html,,,,,, Decahydronaphthalene,91-17-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad5bc64b-ad90-4522-9946-7af15a021d6f/documents/IUC5-b4271866-6b2b-410f-b200-77bb73bf274a_65ec955f-1126-4cb9-8a6d-a3303a807267.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Decahydronaphthalene,91-17-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad5bc64b-ad90-4522-9946-7af15a021d6f/documents/IUC5-b4271866-6b2b-410f-b200-77bb73bf274a_65ec955f-1126-4cb9-8a6d-a3303a807267.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,143 mg/m3,,rat Decahydronaphthalene,91-17-8," Decahydronaphthalene has a low acute toxicity by the oral and dermal route with an oral LD50 (rat) of 4170 mg/kg bw (Smyth et al., 1951) and a dermal LD50 (rat) of 5200 mg/kg bw (Smyth et al., 1951). Upon inhalation exposure the LC50 was 4.08 mg/L air (MacEwen, Vernot, 1978). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad5bc64b-ad90-4522-9946-7af15a021d6f/documents/IUC5-3a3599c4-815a-4b08-bea3-d39648de47c7_65ec955f-1126-4cb9-8a6d-a3303a807267.html,,,,,, Decahydronaphthalene,91-17-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad5bc64b-ad90-4522-9946-7af15a021d6f/documents/IUC5-3a3599c4-815a-4b08-bea3-d39648de47c7_65ec955f-1126-4cb9-8a6d-a3303a807267.html,,oral,LD50,"4,170 mg/kg bw",no adverse effect observed, Decahydronaphthalene,91-17-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad5bc64b-ad90-4522-9946-7af15a021d6f/documents/IUC5-3a3599c4-815a-4b08-bea3-d39648de47c7_65ec955f-1126-4cb9-8a6d-a3303a807267.html,,dermal,LD50,"5,200 mg/kg bw",no adverse effect observed, Decahydronaphthalene,91-17-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad5bc64b-ad90-4522-9946-7af15a021d6f/documents/IUC5-3a3599c4-815a-4b08-bea3-d39648de47c7_65ec955f-1126-4cb9-8a6d-a3303a807267.html,,inhalation,LC50,"4,080 mg/m3",adverse effect observed, Decamethylenediamine,646-25-3,"No repeated-dose toxicity tests are available for the oral and dermal route of exposure. Data waiver are claimed.Because inhalation is the most likely route of human exposure, a sub-acute (14 day) repeated dose inhalation study (based on OECD TG 413, TNO, 2012) with the test item was conducted. Based on microscopic changes observed in the nasal passages of animals of the mid and high concentration groups and the absence of adverse effects in the low concentration group, the No-Observed-Adverse-Effect-Concentration (NOAEC) was placed at the low concentration, namely 0.14 mg/m3 (actual concentration measured by chemical analysis). A data waiver for a 90-day inhalation toxicity study is claimed. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): The study is valid without restriction (Klimisch score 1). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The study is valid without restriction (Klimisch score 1). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6df9d9cd-5fed-45e9-b7e6-acf22491c778/documents/IUC5-13fe2a5c-1db8-40f9-b68d-2e080c38b606_9279ca7b-6e55-405c-8426-322299ee1a68.html,,,,,, Decamethylenediamine,646-25-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6df9d9cd-5fed-45e9-b7e6-acf22491c778/documents/IUC5-13fe2a5c-1db8-40f9-b68d-2e080c38b606_9279ca7b-6e55-405c-8426-322299ee1a68.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,5.7 mg/m3,,rat Decamethylenediamine,646-25-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6df9d9cd-5fed-45e9-b7e6-acf22491c778/documents/IUC5-13fe2a5c-1db8-40f9-b68d-2e080c38b606_9279ca7b-6e55-405c-8426-322299ee1a68.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.14 mg/m3,adverse effect observed,rat Decamethylenediamine,646-25-3,"No acute toxicity studies are available for the dermal and inhalative route of exposure. Data waiver are claimed.The test item is of moderate oral acute toxicity with an oral LD50 (cut-off, rat) of 500 mg/kg bw (BSL, 2008). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is a guideline study with Klimisch score 1 (reliable without restriction). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6df9d9cd-5fed-45e9-b7e6-acf22491c778/documents/IUC5-e5cfb181-7759-4688-8b93-1c90a1e60332_9279ca7b-6e55-405c-8426-322299ee1a68.html,,,,,, Decamethylenediamine,646-25-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6df9d9cd-5fed-45e9-b7e6-acf22491c778/documents/IUC5-e5cfb181-7759-4688-8b93-1c90a1e60332_9279ca7b-6e55-405c-8426-322299ee1a68.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Decamethyltetrasiloxane,141-62-8," In a key 28-day oral gavage study conducted according to OECD Test Guideline 407 and in compliance with GLP (Dow Corning Corporation, 2010a) the NOAEL for L4 was 25 mg/kg bw/day based on significantly elevated mean absolute liver weights, mean liver-to-body weight ratios and mean liver-to-brain weight ratios in males and females treated with 250 mg/kg bw/day and 1000 mg/kg bw/day (p<0.05 or p<0.01) and brown pigment accumulation which was considered to be an adverse finding, due to secondary periportal chronic inflammation and bile duct proliferation In the key 90-day inhalation study (Dow Corning Corporation, 2010b) conducted according to OECD Test Guideline 413 and in compliance with GLP, inhalation of L4 at concentrations of 70 and 400 ppm did not result in any effects attributable to treatment. The NOAEC was therefore considered to be at least 400 ppm (equivalent to 5083 mg/m3), the highest concentration tested. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34454328-a5bc-45da-ac18-266382922ed9/documents/e98f4f4a-5bc6-485a-b8b1-7615b697e17b_bf6d0bdb-33aa-4473-91c0-4aed8a53ba36.html,,,,,, Decamethyltetrasiloxane,141-62-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34454328-a5bc-45da-ac18-266382922ed9/documents/e98f4f4a-5bc6-485a-b8b1-7615b697e17b_bf6d0bdb-33aa-4473-91c0-4aed8a53ba36.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Decamethyltetrasiloxane,141-62-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34454328-a5bc-45da-ac18-266382922ed9/documents/e98f4f4a-5bc6-485a-b8b1-7615b697e17b_bf6d0bdb-33aa-4473-91c0-4aed8a53ba36.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"5,083 mg/m3",,rat Decamethyltetrasiloxane,141-62-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34454328-a5bc-45da-ac18-266382922ed9/documents/e98f4f4a-5bc6-485a-b8b1-7615b697e17b_bf6d0bdb-33aa-4473-91c0-4aed8a53ba36.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"5,083 mg/m3",no adverse effect observed,rat Decamethyltetrasiloxane,141-62-8," The key read-across study for acute oral toxicity determined an LD50 value of >2000 mg/kg in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP (Dow Corning Corporation, 2004a). The key study for acute dermal toxicity determined an LD50 value of >2000 mg/kg in a reliable study conducted according to an appropriate test protocol, and in compliance with GLP (Dow Corning Corporation, 2009a). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34454328-a5bc-45da-ac18-266382922ed9/documents/a86d45f0-d207-4bcc-bf10-90b98989f02d_bf6d0bdb-33aa-4473-91c0-4aed8a53ba36.html,,,,,, Decamethyltetrasiloxane,141-62-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34454328-a5bc-45da-ac18-266382922ed9/documents/a86d45f0-d207-4bcc-bf10-90b98989f02d_bf6d0bdb-33aa-4473-91c0-4aed8a53ba36.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Decamethyltetrasiloxane,141-62-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34454328-a5bc-45da-ac18-266382922ed9/documents/a86d45f0-d207-4bcc-bf10-90b98989f02d_bf6d0bdb-33aa-4473-91c0-4aed8a53ba36.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "bis[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl] decanedioate",122586-52-1, Acute oral toxicity: LD50 (male/female) = > 2000 mg/kg bw (OECD 401/GLP). ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fcec2da-b174-4b00-9bb9-5cf2c11910fb/documents/6ccb3ad4-d6e6-448a-be13-021ad4967e3b_0b395a0a-8963-4b6b-98f7-c7cfd72167cd.html,,,,,, "bis[2,2,6,6-tetramethyl-1-(octyloxy)piperidin-4-yl] decanedioate",122586-52-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fcec2da-b174-4b00-9bb9-5cf2c11910fb/documents/6ccb3ad4-d6e6-448a-be13-021ad4967e3b_0b395a0a-8963-4b6b-98f7-c7cfd72167cd.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate",68130-25-6," NOAEL (Oral, Rat, Sub-acute) = 1000mg/kg/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39ef4ad3-afbe-4f8d-b2e1-1ad9ff88ed8c/documents/9029ac3d-8a81-428a-a9af-e46ed454c1a0_fb091b10-aff0-495f-8f7b-3d74d63a557a.html,,,,,, "Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate",68130-25-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39ef4ad3-afbe-4f8d-b2e1-1ad9ff88ed8c/documents/9029ac3d-8a81-428a-a9af-e46ed454c1a0_fb091b10-aff0-495f-8f7b-3d74d63a557a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Decanoic acid, ester with 2,2-bis(hydroxymethyl)-1,3-propanediol 2-ethylhexanoate octanoate",68130-25-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39ef4ad3-afbe-4f8d-b2e1-1ad9ff88ed8c/documents/0596b6d5-d88e-465b-a392-16dbe895702c_fb091b10-aff0-495f-8f7b-3d74d63a557a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Decanoic acid, mixed diesters with octanoic acid and triethylene glycol",68583-52-8," There is no repeated dose toxicity information available for the test substance. The structurally related material, ethane-1,2-diylbis(oxyethane-2,1-diyl) bis(2-ethylhexanoate)(CAS No. 94 -28 -2) was adiminstered by gavage to male and female Wistar rats for at least 28 days at dose levels in the diet 1500, 5000 and 15000 ppm. These treatments revealed parental toxicity at 15000 ppm. Based on these results, a parental No Observed Adverse Effect Level (NOAEL) of 5000 ppm was derived. When corrected for mean test article intakethe NOAEL of 5000 ppm corresponds to 314-576 mg/kg body weight/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76bd0c16-2628-4f27-a972-394fe7e2ae92/documents/0563f440-c7ec-4425-a383-d89603a5af3f_913176ad-84e5-4620-9e53-535a3804211c.html,,,,,, "Decanoic acid, mixed diesters with octanoic acid and triethylene glycol",68583-52-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76bd0c16-2628-4f27-a972-394fe7e2ae92/documents/0563f440-c7ec-4425-a383-d89603a5af3f_913176ad-84e5-4620-9e53-535a3804211c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,314 mg/kg bw/day,,rat "Decanoic acid, mixed diesters with octanoic acid and triethylene glycol",68583-52-8," In an acute oral toxicity study in male and female Wistar rats with the test substance, no deaths or adverse clinical signs were noted. There were no adverse necropsy findings. The acute oral LD 50 value was found to be greater than 5000 mg/kg bw. In an acute dermal toxicity study in male and female New Zealand White rabbits with a surrogate material, no deaths were noted during the observation period. There were no necrospsy findings. The acute dermal LD 50 value was found to be greater than 20 g/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76bd0c16-2628-4f27-a972-394fe7e2ae92/documents/14d2fce7-459b-40f1-bc08-35375fd55c8d_913176ad-84e5-4620-9e53-535a3804211c.html,,,,,, "Decanoic acid, mixed diesters with octanoic acid and triethylene glycol",68583-52-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76bd0c16-2628-4f27-a972-394fe7e2ae92/documents/14d2fce7-459b-40f1-bc08-35375fd55c8d_913176ad-84e5-4620-9e53-535a3804211c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Decanoic acid, mixed diesters with octanoic acid and triethylene glycol",68583-52-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76bd0c16-2628-4f27-a972-394fe7e2ae92/documents/14d2fce7-459b-40f1-bc08-35375fd55c8d_913176ad-84e5-4620-9e53-535a3804211c.html,,dermal,LD50,"20,000 mg/kg bw",no adverse effect observed, "Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid",68441-66-7, NOAEL 1000 mg/kg bw/day based on read across to structural analogue. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/452196e0-735b-4d7b-b326-bfbfed0f1598/documents/IUC5-dc394122-f085-4d0e-84ac-7cab69644900_a582c555-d899-4165-8b76-b9ae1f9446f5.html,,,,,, "Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid",68441-66-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/452196e0-735b-4d7b-b326-bfbfed0f1598/documents/IUC5-dc394122-f085-4d0e-84ac-7cab69644900_a582c555-d899-4165-8b76-b9ae1f9446f5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid",68441-66-7," Acute toxicity - oral The oral median lethal dose (LD50) value of Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid in Wistar Han rats was established to exceed 2000 mg/kg body weight. Acute Inhalation: In accordance with column 2 of Annex VIII, the acute inhalation test (as required in section 8.5.2.) does not need to be performed for the following reasons:1. inhalation is not the most likely route of exposure based on criteria of use. The vapour pressure of the substance is proposed to be low and exposure to aerosols, particles or droplets of an inhalable size is not anticipated during proposed uses. Acute Dermal: Acute toxicity by dermal route (required in section 8.5.3.) does not need to be conducted. Additionally, based on physico-chemical, structural and other toxicological properties the substance is not expected to have potential for a significant rate of absorption through the skin. Results of an in vitro assessment demonstrated no irritation and the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route.  Dermal toxicity is not proposed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/452196e0-735b-4d7b-b326-bfbfed0f1598/documents/IUC5-51f08cfd-2b6b-468f-9cb2-053e9ebc2c70_a582c555-d899-4165-8b76-b9ae1f9446f5.html,,,,,, "Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid",68441-66-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/452196e0-735b-4d7b-b326-bfbfed0f1598/documents/IUC5-51f08cfd-2b6b-468f-9cb2-053e9ebc2c70_a582c555-d899-4165-8b76-b9ae1f9446f5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Decanoic acid, mixed esters with dipentaerythritol, octanoic acid and valeric acid",68441-66-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/452196e0-735b-4d7b-b326-bfbfed0f1598/documents/IUC5-51f08cfd-2b6b-468f-9cb2-053e9ebc2c70_a582c555-d899-4165-8b76-b9ae1f9446f5.html,,dermal,LD50,"2,000 mg/kg bw",, "Decanoic acid, mixed esters with heptanoic acid, isovaleric acid, octanoic acid and pentaerythritol",68130-51-8," The substance, CAS 68130-51-8; EC  268-594-6, is analogous to the substances to be read across to, in terms of basic form, and the degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of repeated dose toxicity via the oral route. The substance is not considered to be toxic via the oral route following repeated exposure on the basis of read across. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e20a3e2-16e3-4fe0-9f33-3b1f7d34391a/documents/0ad0e6fc-d998-46a0-b44c-8502c9b77f61_10df3a34-e9d7-4731-bbbf-4ca2769f2b8a.html,,,,,, "Decanoic acid, mixed esters with heptanoic acid, isovaleric acid, octanoic acid and pentaerythritol",68130-51-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e20a3e2-16e3-4fe0-9f33-3b1f7d34391a/documents/0ad0e6fc-d998-46a0-b44c-8502c9b77f61_10df3a34-e9d7-4731-bbbf-4ca2769f2b8a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Decanoic acid, mixed esters with heptanoic acid, isovaleric acid, octanoic acid and pentaerythritol",68130-51-8," Acute toxicity: oral LD50 is greater than 2000 mg/kg body weight after single oral administration to Wistar rats. Acute toxicity: dermal The substance, CAS 68130-51-8; EC  268-594-6, is analogous to the substances to be read across to, in terms of basic form, and the degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of acute dermal toxicity. The substance is not considered to be acutely toxic via the dermal  route on the basis of read across. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e20a3e2-16e3-4fe0-9f33-3b1f7d34391a/documents/1ae81043-30cb-471f-b8ed-cc533f6ccdaa_10df3a34-e9d7-4731-bbbf-4ca2769f2b8a.html,,,,,, "Decanoic acid, mixed esters with heptanoic acid, isovaleric acid, octanoic acid and pentaerythritol",68130-51-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e20a3e2-16e3-4fe0-9f33-3b1f7d34391a/documents/1ae81043-30cb-471f-b8ed-cc533f6ccdaa_10df3a34-e9d7-4731-bbbf-4ca2769f2b8a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Decanoic acid, mixed esters with heptanoic acid, isovaleric acid, octanoic acid and pentaerythritol",68130-51-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e20a3e2-16e3-4fe0-9f33-3b1f7d34391a/documents/1ae81043-30cb-471f-b8ed-cc533f6ccdaa_10df3a34-e9d7-4731-bbbf-4ca2769f2b8a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Decanoic acid, mixed esters with heptanoic acid, octanoic acid and pentaerythritol",68441-67-8," RA-S, CAS 68424-31-7, Key, Croda, Brammer, 1993, rep. dose, 28 d, oral, RL2 - NOAEL 1450 mg/kg bw/d Subacute 28 day oral toxicity- NOAEL 150 mg/kg/day male/female rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0165dbd-1801-463a-aa53-9bd3fe84517e/documents/44bf32ca-fe71-4ed4-be11-6884c3b0a036_9a4a3245-de3a-4e46-a0c1-2edb0ba7b173.html,,,,,, "Decanoic acid, mixed esters with heptanoic acid, octanoic acid and pentaerythritol",68441-67-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0165dbd-1801-463a-aa53-9bd3fe84517e/documents/44bf32ca-fe71-4ed4-be11-6884c3b0a036_9a4a3245-de3a-4e46-a0c1-2edb0ba7b173.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Decanoic acid, mixed esters with heptanoic acid, octanoic acid and pentaerythritol",68441-67-8, Acute toxicity: oral LD50 is greater than 2000 mg/kg body weight after single oral administration to Wistar rats. Acute toxicity: dermal Acute Dermal Toxicity: LD50 > 2000 mg/kg (male/female Wistar rats) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0165dbd-1801-463a-aa53-9bd3fe84517e/documents/ca723756-a3b3-44f8-ba24-ef336e4589f9_9a4a3245-de3a-4e46-a0c1-2edb0ba7b173.html,,,,,, "Decanoic acid, mixed esters with heptanoic acid, octanoic acid and pentaerythritol",68441-67-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0165dbd-1801-463a-aa53-9bd3fe84517e/documents/ca723756-a3b3-44f8-ba24-ef336e4589f9_9a4a3245-de3a-4e46-a0c1-2edb0ba7b173.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Decanoic acid, mixed esters with heptanoic acid, octanoic acid and pentaerythritol",68441-67-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0165dbd-1801-463a-aa53-9bd3fe84517e/documents/ca723756-a3b3-44f8-ba24-ef336e4589f9_9a4a3245-de3a-4e46-a0c1-2edb0ba7b173.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Decanoic acid, mixed esters with heptanoic acid, octanoic acid and trimethylolpropane",68130-53-0,"Subchronic repeated dose toxicty: oral: no observed adverse effect level (NOAEL) of Hatcol 1510 in Sprague Dawley rats following 90-day oral gavage dose is 1000 mg/kg/day, the highest dose level tested.   Subacute repeated dose toxicity: oral: 14day no-observed-adverse-effect level (NOAEL) was considered to be 1000 mg/kg/day for male and female rats dosed with the test substance, decanoic acid, mixed esters with heptanoic acid, octanoic acid and trimethylolpropane (Hatcol 1510).   Subchronic repeated dose toxicity: inhalation 90d NOAEC was determined to be 0.5 mg/L air.   Subchronic repeated dose toxicity: dermal: 90d NOAEL was determined to be ≥ 2000 mg/kg/day.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19d24cda-8b4f-4a5e-b324-8be27c19179c/documents/IUC5-f9b8005c-912a-49cf-9d2d-54fdd485c992_32e0179e-513d-44df-b976-3de28c4fa886.html,,,,,, "Decanoic acid, mixed esters with heptanoic acid, octanoic acid and trimethylolpropane",68130-53-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19d24cda-8b4f-4a5e-b324-8be27c19179c/documents/IUC5-f9b8005c-912a-49cf-9d2d-54fdd485c992_32e0179e-513d-44df-b976-3de28c4fa886.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Decanoic acid, mixed esters with heptanoic acid, octanoic acid and trimethylolpropane",68130-53-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19d24cda-8b4f-4a5e-b324-8be27c19179c/documents/IUC5-f9b8005c-912a-49cf-9d2d-54fdd485c992_32e0179e-513d-44df-b976-3de28c4fa886.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rat "Decanoic acid, mixed esters with heptanoic acid, octanoic acid and trimethylolpropane",68130-53-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19d24cda-8b4f-4a5e-b324-8be27c19179c/documents/IUC5-f9b8005c-912a-49cf-9d2d-54fdd485c992_32e0179e-513d-44df-b976-3de28c4fa886.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,500 mg/m3,,rat "Decanoic acid, mixed esters with heptanoic acid, octanoic acid and trimethylolpropane",68130-53-0,Acute oral toxicity using the OECD 420 method was > 2000 mg/kg body weight. Acute dermal toxicity using the OECD 402 method was > 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19d24cda-8b4f-4a5e-b324-8be27c19179c/documents/IUC5-4699fbf6-c220-4cb8-9d5f-21e0c652ca29_32e0179e-513d-44df-b976-3de28c4fa886.html,,,,,, "Decanoic acid, mixed esters with heptanoic acid, octanoic acid and trimethylolpropane",68130-53-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19d24cda-8b4f-4a5e-b324-8be27c19179c/documents/IUC5-4699fbf6-c220-4cb8-9d5f-21e0c652ca29_32e0179e-513d-44df-b976-3de28c4fa886.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Decanoic acid, mixed esters with heptanoic acid, octanoic acid and trimethylolpropane",68130-53-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19d24cda-8b4f-4a5e-b324-8be27c19179c/documents/IUC5-4699fbf6-c220-4cb8-9d5f-21e0c652ca29_32e0179e-513d-44df-b976-3de28c4fa886.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid",71010-76-9,All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7cdecc7-3b1b-4e8f-88c8-f942418a64e9/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_3d5d0fa4-8e75-4fd6-9485-38fb55cb911a.html,,,,,, "Decanoic acid, mixed esters with heptanoic acid, octanoic acid, pentaerythritol and valeric acid",71010-76-9,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7cdecc7-3b1b-4e8f-88c8-f942418a64e9/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_3d5d0fa4-8e75-4fd6-9485-38fb55cb911a.html,,,,,, Decanoyl chloride,112-13-0, No studies are available. The registered substance is an on-site isolated intermediate and no further testing is required. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a0dbf2f-e727-4743-827b-67c2e0633857/documents/IUC5-3d6891ca-a84b-468d-9785-775af9878d35_a7a805df-8167-4155-ae01-770022bf1063.html,,,,,, Decanoyl chloride,112-13-0," Acid chlorides are considered corrosive to mucus membranes.  ""Study(ies) do not generally need to be conducted if the substance is classified as corrosive to the skin (Annex VIII 8.5).""  In addition, the registered substance is an on-site isolated intermediate.  Per the Guidance on Intermediates, ""If the manufacturer confirms in his IUCLID registration dossier that the on-site isolated intermediate is manufactured and used under strictly controlled conditions (see section 2.1), the information requirements on the substance intrinsic properties (physicochemical, human health and environment properties) are reduced to already available data (e.g. information he holds himself or that he can obtain from other sources) and only study summaries have to be submitted even if a full study report is available (Article 17) (see 2.2)."" ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a0dbf2f-e727-4743-827b-67c2e0633857/documents/IUC5-a838f335-83c7-4835-a773-4c823760a124_a7a805df-8167-4155-ae01-770022bf1063.html,,,,,, Decene,25339-53-1," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92a74949-a32a-4841-b309-d9cc1dcf6595/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_4d3861c4-d99c-4989-b541-51381934aeb1.html,,,,,, Decene,25339-53-1,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92a74949-a32a-4841-b309-d9cc1dcf6595/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_4d3861c4-d99c-4989-b541-51381934aeb1.html,,,,,, Decyl 2-ethylhexanoate,93777-46-9,Oral (OECD 407): NOAEL ≥ 1000 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9158f376-2463-4342-ac24-a422a8812efc/documents/6e076165-eb81-49af-9c43-a1c3cd7a9fc9_cebca383-7847-4a8d-9b62-dfe5764497ab.html,,,,,, Decyl 2-ethylhexanoate,93777-46-9, Oral (OECD 401): LD50 > 2000 mg/kg bw Inhalation (OECD 436): LC50 > 5.7 mg/L Dermal: no data available ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9158f376-2463-4342-ac24-a422a8812efc/documents/4c644e3e-5529-4a5e-ad32-7b752460cc3d_cebca383-7847-4a8d-9b62-dfe5764497ab.html,,,,,, Decyl 2-ethylhexanoate,93777-46-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9158f376-2463-4342-ac24-a422a8812efc/documents/4c644e3e-5529-4a5e-ad32-7b752460cc3d_cebca383-7847-4a8d-9b62-dfe5764497ab.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Decyl 2-ethylhexanoate,93777-46-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9158f376-2463-4342-ac24-a422a8812efc/documents/4c644e3e-5529-4a5e-ad32-7b752460cc3d_cebca383-7847-4a8d-9b62-dfe5764497ab.html,,inhalation,LC50,5.7 mg/m3,no adverse effect observed, "Decyl dihydrogen phosphate, potassium salt",68427-32-7," The available study on decyldihydrogenphosphate, potassium salt (CAS: 68427 -32 -7) is performed pre-GLP and before OECD guideline was available. It has been evaluated as Klimish rating 2 due to the limited reported study with basic data performed comparable to guideline/standard.   In the full scale test, rats were administered 1.0 to 6.4 ml/kg bodyweight of the tested product consisting of 45% decyldihydrogenphosphate, potassium salt (CAS: 68427 -32 -7). Rats treated with water alone (6.4 ml/kg ) served as controls. Based on the identified specific density of the substance (CAS no 68427-32-7) of 1.44 g/ml as given under section 4.4 in IUCLID, the LD50 value will be between 2000 – 5000 mg/kg bw and thereforenot to be classified for acute toxicity according to Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008.   During the observation period of 14 days, a record was kept of all mortalities and signs of toxicity. Signs of reaction to treatment, observed shortly after dosing, included lethargy and piloerection. These signs were accompanied by a slight increase in salivation in rats treated at 2.5 ml/kg and above and later by slight ataxia in female rats treated at 2.5 ml/kg and all rats at 4.0 and 6.4 ml/kg. Death occurred between two and ten hours after treatment. Autopsy revealed slight to moderate haemorrhage of the stomach and small intestines, and slight injection of mesenteric blood vessels. Slight darkening of the liver and kidneys was observed in four rats. Recovery of survivors, as judged by external appearance and behaviour, was apparently complete within 5 days of treatment. This observation was substantiated by normal bodyweight gains compared with controls, and normal autopsy findings. The acute median lethal oral dose (LD50) to rats of the tested product consisting of 45% a.s. was calculated to be: 5.7 mg/kg bodyweight. The corresponding LD50 value Decyldihydrogenphosphate, potassium salt (CAS: 68427 -32 -7) is estimated to 2592 mg/kg bw based on concentration. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/524f8afd-8eaa-48cf-900b-9a1e6fb4db06/documents/340eb9f5-5eaa-44ef-838a-21cbda150471_fd4590b9-f467-4d4a-86a4-f66c3f5127a2.html,,,,,, "Decyl dihydrogen phosphate, potassium salt",68427-32-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/524f8afd-8eaa-48cf-900b-9a1e6fb4db06/documents/340eb9f5-5eaa-44ef-838a-21cbda150471_fd4590b9-f467-4d4a-86a4-f66c3f5127a2.html,,oral,LD50,"2,592 mg/kg bw",adverse effect observed, Decyl methacrylate,3179-47-3,"Results of the repeated dose studies on the structurally closely related esters 2-Ethylhexyl methacrylate (C8-Ester) and Dodecyl methacrylate (C12-Ester) are considered as representative for the repeated dose toxicity of n-Decyl methacrylate (n-C10-Ester).In an OECD 422 GLP study with Dodecyl methacrylate in rats, there was no evidence for toxicity up to the highest administered dose. The NOAEL was 1000 mg/kg/d. In a fully valid 90 d OECD 408 GLP study with 2-Ethylhexyl methacrylate, the NOAEL was 120 mg/kg body weight/day in rats.Taken as a whole there are sufficient data available for assessment purposes so for the sake of animal welfare it is not proposed to conduct further repeated dose studies. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/97e7d75c-8b77-40f6-b6fc-b31844b04a82/documents/2da5cdcf-791f-4acb-ad57-096570572b7d_f1c506ed-bc8d-4b8d-818c-fbf74a4a79fc.html,,,,,, Decyl methacrylate,3179-47-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/97e7d75c-8b77-40f6-b6fc-b31844b04a82/documents/2da5cdcf-791f-4acb-ad57-096570572b7d_f1c506ed-bc8d-4b8d-818c-fbf74a4a79fc.html,Chronic toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat Decyl methacrylate,3179-47-3,"There is no information concerning acute toxicity for n-Decyl methacrylate available. The results of acute toxicity studies of the structurally closely related Isodecyl methacrylate (i-C10-Ester) are considered as representative for acute toxicity of n-Decyl methacrylate (n-C10 -Ester).The acute toxicity of Isodecyl methacrylate was demonstrated to be low by the oral and dermal route. The absence of inhalation toxicity was demonstrated in a study where test animals were exposed to a saturated atmosphere. However, the inhalation route is not of relevance due to the low vapour pressure of Isodecyl methacrylate and n-Decyl methacrylate. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97e7d75c-8b77-40f6-b6fc-b31844b04a82/documents/cc869766-b4ab-4c83-b344-fa9b51aa655c_f1c506ed-bc8d-4b8d-818c-fbf74a4a79fc.html,,,,,, Decyl methacrylate,3179-47-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97e7d75c-8b77-40f6-b6fc-b31844b04a82/documents/cc869766-b4ab-4c83-b344-fa9b51aa655c_f1c506ed-bc8d-4b8d-818c-fbf74a4a79fc.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Decyl methacrylate,3179-47-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97e7d75c-8b77-40f6-b6fc-b31844b04a82/documents/cc869766-b4ab-4c83-b344-fa9b51aa655c_f1c506ed-bc8d-4b8d-818c-fbf74a4a79fc.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, Decyldimethylamine,1120-24-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): good ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30f64df8-b254-4b8c-b7b8-6f20bd2c01e6/documents/c8d3b417-8f67-494e-ab41-fcfa67eb8af3_0fd62cfa-fb3b-4b47-8832-6b8b4a16f8bd.html,,,,,, Decyldimethylamine,1120-24-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30f64df8-b254-4b8c-b7b8-6f20bd2c01e6/documents/c8d3b417-8f67-494e-ab41-fcfa67eb8af3_0fd62cfa-fb3b-4b47-8832-6b8b4a16f8bd.html,Chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Decyldimethylamine,1120-24-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): good ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30f64df8-b254-4b8c-b7b8-6f20bd2c01e6/documents/5d95b1b8-d6fa-4e84-bb62-fac4f8ebab70_0fd62cfa-fb3b-4b47-8832-6b8b4a16f8bd.html,,,,,, Decyldimethylamine,1120-24-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30f64df8-b254-4b8c-b7b8-6f20bd2c01e6/documents/5d95b1b8-d6fa-4e84-bb62-fac4f8ebab70_0fd62cfa-fb3b-4b47-8832-6b8b4a16f8bd.html,,oral,LD50,"1,015 mg/kg bw",adverse effect observed, Decyloxirane,2855-19-8,The NOAEL for oral repeated dose toxicity was determined to be 750 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9937db1c-c3cb-4de7-b1e1-211c2819704c/documents/6bc6f201-1b37-489f-8708-203e5dd7092a_ff94fb14-a095-4621-a544-d54b9dfed093.html,,,,,, Decyloxirane,2855-19-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9937db1c-c3cb-4de7-b1e1-211c2819704c/documents/6bc6f201-1b37-489f-8708-203e5dd7092a_ff94fb14-a095-4621-a544-d54b9dfed093.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat Decyloxirane,2855-19-8,The oral LD50 was determined to be >5000 mg/kg bw.The dermal LD50 was determined to be >2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9937db1c-c3cb-4de7-b1e1-211c2819704c/documents/613f106f-7cd9-46c8-b3bc-cb7671fc7ab7_ff94fb14-a095-4621-a544-d54b9dfed093.html,,,,,, Decyloxirane,2855-19-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9937db1c-c3cb-4de7-b1e1-211c2819704c/documents/613f106f-7cd9-46c8-b3bc-cb7671fc7ab7_ff94fb14-a095-4621-a544-d54b9dfed093.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Decyloxirane,2855-19-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9937db1c-c3cb-4de7-b1e1-211c2819704c/documents/613f106f-7cd9-46c8-b3bc-cb7671fc7ab7_ff94fb14-a095-4621-a544-d54b9dfed093.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, decyltrimethoxysilane,5575-48-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study was GLP-compliant and performed according to the OECD Testing Guideline 423. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eab248f3-49b3-4d65-85b4-3d471083cc83/documents/b6f56e11-c844-4cfc-bd8f-50f70776406c_64ce49fd-5ef4-461a-bf81-edbe4a1571f2.html,,,,,, decyltrimethoxysilane,5575-48-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eab248f3-49b3-4d65-85b4-3d471083cc83/documents/b6f56e11-c844-4cfc-bd8f-50f70776406c_64ce49fd-5ef4-461a-bf81-edbe4a1571f2.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "Dehydratase, carbonate",9001-03-0,"Carbonic was not tested for acute toxicity, but two closely-related enzymes, pectate lyase and pectin lyase, were tested for acute toxicity. The acute toxicity of pectate lyase and pectin lyase was tested by administration by gavage as a single oral dose to one group of five male and five female rats followed by an observation period of 14 days. No signs of toxicity were observed among the rats treated with a single oral dose of pectate lyase corresponding 2447 mg enzyme concentrate dry matter/kg bodyweight (equivalent to 1526 mg aep/kg bodyweight) or a single dose of pectin lyase corresponding to 2218 mg enzyme concentrate dry matter/kg bodyweight (equivalent to 1428 mg aep/kg bodyweight). Based on the similarity of the tested enzymes with carbonic anhydrase - all belonging to the same enzyme sub-subclass - it can be concluded that similar results are expected for carbonic anhydrase. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff9c1d7b-9813-481d-96ca-fc8af4635272/documents/f7a84d21-f680-4b06-9745-d31490d30ebd_8ed79727-cfbb-42b8-b0c5-a9c45446cc13.html,,,,,, Demeclocycline hydrochloride,64-73-3,"LD 50(oral, adult rats): 2372 mg/kg/day;LD 50(oral, newborn rats (< 2 days)): 2107 mg/kg/day ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71b75a9c-5b6b-4e8b-a8e0-7246349a6e7b/documents/IUC5-dd4aba11-fdd4-4f11-b857-b4d8eaa16a0e_f0804249-a506-4752-937a-b2a20b525275.html,,,,,, Demeclocycline hydrochloride,64-73-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71b75a9c-5b6b-4e8b-a8e0-7246349a6e7b/documents/IUC5-dd4aba11-fdd4-4f11-b857-b4d8eaa16a0e_f0804249-a506-4752-937a-b2a20b525275.html,,oral,LD50,"2,372 mg/kg bw",no adverse effect observed, Desipramine,50-47-5, Mouse oral LD50 of desipramine is 448 mg/kg/bw. Rat oral LD50 of desipramine is 375 mg/kg bw. Rabbit oral LD50 of desipramine is 1000 mg/kg bw. No data available for acute dermal and inhalation toxicity. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/becb7b8f-5aee-403a-b6f9-e461ef825458/documents/76dd0a44-c78f-428b-949d-dd0e9b43966a_589529c5-f749-458c-b534-47828332e2c7.html,,,,,, Desipramine,50-47-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/becb7b8f-5aee-403a-b6f9-e461ef825458/documents/76dd0a44-c78f-428b-949d-dd0e9b43966a_589529c5-f749-458c-b534-47828332e2c7.html,,oral,LD50,375 mg/kg bw,adverse effect observed, Desipramine hydrochloride,58-28-6," Two acute oral toxicity data are available, as secondary source, for desipramine hydrochloride: mouse, LD50, oral = 315 mg/kg rat, LD50, oral = 871 mg/kg. The substance is classified as Acute Tox. 4 H302. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f187bd75-2d2d-42d3-9d03-e7ddf12f1363/documents/cf2e0bd6-0626-4d40-a000-57aa035d4106_d95a4ed6-89f9-436f-9860-77d1d70f3986.html,,,,,, Desipramine hydrochloride,58-28-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f187bd75-2d2d-42d3-9d03-e7ddf12f1363/documents/cf2e0bd6-0626-4d40-a000-57aa035d4106_d95a4ed6-89f9-436f-9860-77d1d70f3986.html,,oral,LD50,315 mg/kg bw,adverse effect observed, "(1S)-2,3,4,6-TETRA-O-ACETYL-1,5-ANHYDRO-1-(3-{[5-(4-FLUOROPHENYL)THIOPHEN-2-YL]METHYL}-4-METHYLPHENYL)-D-GLUCITOL",866607-35-4," Repeated dose toxicity - oral: In a combined 28-day repeated dose toxicity study with the reproduction/ developmental toxicity screening test, the test substance was administered daily to rats up to a dose level of 1000 mg/kg body weight/day (OECD 422; Mounier, 2017). The NOAEL is established to be at least 1000 mg/kg. Based on the available data and according to the criteria of the CLP Regulation, the test item is therfore not classified as STOT RE according to the CLP Regulation. Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a766db2-dbfd-49aa-bfba-0152fe6830d1/documents/6cc0da4e-4c74-4714-836c-84888d288fa1_941c63fa-0a8a-4cc2-a15b-9503bd1c7b50.html,,,,,, "(1S)-2,3,4,6-TETRA-O-ACETYL-1,5-ANHYDRO-1-(3-{[5-(4-FLUOROPHENYL)THIOPHEN-2-YL]METHYL}-4-METHYLPHENYL)-D-GLUCITOL",866607-35-4,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a766db2-dbfd-49aa-bfba-0152fe6830d1/documents/6cc0da4e-4c74-4714-836c-84888d288fa1_941c63fa-0a8a-4cc2-a15b-9503bd1c7b50.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "(1S)-2,3,4,6-TETRA-O-ACETYL-1,5-ANHYDRO-1-(3-{[5-(4-FLUOROPHENYL)THIOPHEN-2-YL]METHYL}-4-METHYLPHENYL)-D-GLUCITOL",866607-35-4," Acute toxicity: Oral An acute oral toxicity study was performed on female Wistar rats, following the acute toxic class method in accordance with the OECD Guideline 423, the LD50 was established to be greater than 2000 mg/kg, observed over a period of 14 days (Giannini 2008). The study has been performed in compliance with GLP principles. Acute toxicity: inhalation No study is available. This endpoint is waived based on following justification: According to the REACH Regulation, for substances other than gasses, only one additional route of exposure should be tested other than the oral route of exposure for acute toxicity (column 2, Annex VIII, section 8.5). Therefore, it is not necessary to perform an acute toxicity study via the inhalation route of exposure. Acute toxicity: dermal No study is available. The study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (skin irritation, skin sensitisation). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a766db2-dbfd-49aa-bfba-0152fe6830d1/documents/d0d99f6d-58c2-4663-8e04-cbd2248d1af1_941c63fa-0a8a-4cc2-a15b-9503bd1c7b50.html,,,,,, "(1S)-2,3,4,6-TETRA-O-ACETYL-1,5-ANHYDRO-1-(3-{[5-(4-FLUOROPHENYL)THIOPHEN-2-YL]METHYL}-4-METHYLPHENYL)-D-GLUCITOL",866607-35-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a766db2-dbfd-49aa-bfba-0152fe6830d1/documents/d0d99f6d-58c2-4663-8e04-cbd2248d1af1_941c63fa-0a8a-4cc2-a15b-9503bd1c7b50.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(1s)-1,5-anhydro-2,3,4,6-tetrakis-o-(2,2-dimethylpropanoyl)-1-(3-{[5-(4-fluorophenyl)thiophen-2-yl]methyl}-4-methylphenyl)-d-glucitol",1283129-18-9,"Repeated dose toxicity - oral: In a combined 28-day repeated dose toxicity study with the reproduction/ developmental toxicity screening test, the test substance was administered daily to rats up to a dose level of 1000 mg/kg body weight/day (OECD 422; Peter, 2017). The NOAEL is established to be at least 1000 mg/kg. In a 90 day repeated dose toxicity study performed according to OECD 408 guidelines, no test item-related effects were observed up to the highest tested dose level (1000 mg/kg bw/day). The NOAEL was considered to be at least 1000 mg/kg bw/day (Lourens, 2022).    Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP-compliant study, performed according to OECD guidelines ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6fcbce8d-571d-4b00-8e5d-605b64765e1a/documents/190a8442-6cd2-4a59-a47c-f5ddc018c8e5_51395d34-8e00-4836-abf7-2dd1e96d6465.html,,,,,, "(1s)-1,5-anhydro-2,3,4,6-tetrakis-o-(2,2-dimethylpropanoyl)-1-(3-{[5-(4-fluorophenyl)thiophen-2-yl]methyl}-4-methylphenyl)-d-glucitol",1283129-18-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6fcbce8d-571d-4b00-8e5d-605b64765e1a/documents/190a8442-6cd2-4a59-a47c-f5ddc018c8e5_51395d34-8e00-4836-abf7-2dd1e96d6465.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "(1s)-1,5-anhydro-2,3,4,6-tetrakis-o-(2,2-dimethylpropanoyl)-1-(3-{[5-(4-fluorophenyl)thiophen-2-yl]methyl}-4-methylphenyl)-d-glucitol",1283129-18-9," Acute toxicity: Oral In two separate acute oral toxicity study in female rats, following the acute toxic class method in accordance with the OECD Guideline 423, the LD50 was established to be greater than 2000 mg/kg (Latour 2017 and Herlich 2012).   Acute toxicity: Inhalation In addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For T003422, a key study is available for the dermal route of exposure. Therefore, an acute inhalation toxicity study should not be performed.   Acute toxicity: Dermal In an acute dermal toxicity study in male and female Crl:WI (Han) (SPF) rats, following the standard acute method according to OECD Guideline 402 and EC method B.3, the LD50 was established to exceed 2000 mg/kg body weight (Latour, 2016). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fcbce8d-571d-4b00-8e5d-605b64765e1a/documents/a02cdd20-482a-4d34-b1be-e1548af6e1d2_51395d34-8e00-4836-abf7-2dd1e96d6465.html,,,,,, "(1s)-1,5-anhydro-2,3,4,6-tetrakis-o-(2,2-dimethylpropanoyl)-1-(3-{[5-(4-fluorophenyl)thiophen-2-yl]methyl}-4-methylphenyl)-d-glucitol",1283129-18-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fcbce8d-571d-4b00-8e5d-605b64765e1a/documents/a02cdd20-482a-4d34-b1be-e1548af6e1d2_51395d34-8e00-4836-abf7-2dd1e96d6465.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(1s)-1,5-anhydro-2,3,4,6-tetrakis-o-(2,2-dimethylpropanoyl)-1-(3-{[5-(4-fluorophenyl)thiophen-2-yl]methyl}-4-methylphenyl)-d-glucitol",1283129-18-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fcbce8d-571d-4b00-8e5d-605b64765e1a/documents/a02cdd20-482a-4d34-b1be-e1548af6e1d2_51395d34-8e00-4836-abf7-2dd1e96d6465.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, 2,3,4,6-tetraacetate, (1S)-",461432-25-7," In an oral OECD422 screening study with rats, the NOAEL was determined to be at least 400 mg/kg bw/day, based on the absence of adverse effects up to and including the highest dose level tested. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85703c9c-b111-4208-ae49-95f599f9b926/documents/94d8c85f-af97-4d70-923c-e0e379f74642_88dfa40d-e7a4-4e0d-81ad-be5895b041e2.html,,,,,, "D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, 2,3,4,6-tetraacetate, (1S)-",461432-25-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85703c9c-b111-4208-ae49-95f599f9b926/documents/94d8c85f-af97-4d70-923c-e0e379f74642_88dfa40d-e7a4-4e0d-81ad-be5895b041e2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat "D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, 2,3,4,6-tetraacetate, (1S)-",461432-25-7," A key study was completed for acute oral toxicity according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method) and EU Method b.1 tris (Acute Oral Toxicity - Acute Toxic Class Method). A key study was also completed for the acute dermal toxicity according to OECD Guideline 402 (Acute Dermal Toxicity), EU Method B.3 (Acute Dermal Toxicity), EPA OPPTS 870.1200 (Acute Dermal Toxicity), and Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000; including the most recent partial revisions. Both of these studies were completed under GLP. An acute inhalation study was waived as exposure to humans via inhalation is not likely due to the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles, or droplets of inhalable size (exposure considerations). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85703c9c-b111-4208-ae49-95f599f9b926/documents/81e0a60c-6cb7-499b-ac27-506cfce98671_88dfa40d-e7a4-4e0d-81ad-be5895b041e2.html,,,,,, "D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, 2,3,4,6-tetraacetate, (1S)-",461432-25-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85703c9c-b111-4208-ae49-95f599f9b926/documents/81e0a60c-6cb7-499b-ac27-506cfce98671_88dfa40d-e7a4-4e0d-81ad-be5895b041e2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "D-Glucitol, 1,5-anhydro-1-C-[4-chloro-3-[(4-ethoxyphenyl)methyl]phenyl]-, 2,3,4,6-tetraacetate, (1S)-",461432-25-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85703c9c-b111-4208-ae49-95f599f9b926/documents/81e0a60c-6cb7-499b-ac27-506cfce98671_88dfa40d-e7a4-4e0d-81ad-be5895b041e2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 1-deoxy-1-formamido-D-glucitol,89182-60-5,"Oral, subacute 4 weeks (Rat-Wistar, GLP, OECD TG 407): NOAEL = 1000 mg/kg[Bayer AG, Report No. PH-34477, 2006-05-31] ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1de2412-fa4a-49ea-a51b-3baeb7489494/documents/IUC5-43eb64b3-ba99-4332-9a0c-648517c5b435_e662b675-4de0-4fcc-adb8-35830df87775.html,,,,,, 1-deoxy-1-formamido-D-glucitol,89182-60-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1de2412-fa4a-49ea-a51b-3baeb7489494/documents/IUC5-43eb64b3-ba99-4332-9a0c-648517c5b435_e662b675-4de0-4fcc-adb8-35830df87775.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 1-deoxy-1-formamido-D-glucitol,89182-60-5,"Oral (Rat-Wistar, GLP, OECD TG 401): LD50 > 2000 mg/kg[Bayer AG, Report No. PH-18819, 1990-02-20]Inhalation (Rat-Wistar, GLP, OECD TG 403, EU Method B.2, OPPTS 870.1300): LC50 > 4575 mg/m³[Bayer AG, Report No. PH-34479, 2006-06-01] ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1de2412-fa4a-49ea-a51b-3baeb7489494/documents/IUC5-5e0ca80c-2619-4926-964d-08ac0f31d378_e662b675-4de0-4fcc-adb8-35830df87775.html,,,,,, "2-benzofuran-1,3-dione, addition product with (2R,3R,4R,5S)-hexane-1,2,3,4,5,6-hexol and 2-(2-hydroxyethoxy)ethanol, propoxylated",113163-37-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11d35a2f-3376-4019-aa9c-6b9c2011854d/documents/IUC5-77eb3375-cce8-4c81-ab1e-ce6dc7dd0900_12337aa3-540a-4ea8-b631-3c14cdc6b38f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2-benzofuran-1,3-dione, addition product with (2R,3R,4R,5S)-hexane-1,2,3,4,5,6-hexol and 2-(2-hydroxyethoxy)ethanol, propoxylated",113163-37-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11d35a2f-3376-4019-aa9c-6b9c2011854d/documents/IUC5-03d365e2-eec4-4d28-a225-34f062572996_12337aa3-540a-4ea8-b631-3c14cdc6b38f.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-benzofuran-1,3-dione, addition product with (2R,3R,4R,5S)-hexane-1,2,3,4,5,6-hexol and 2-(2-hydroxyethoxy)ethanol, propoxylated",113163-37-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11d35a2f-3376-4019-aa9c-6b9c2011854d/documents/IUC5-03d365e2-eec4-4d28-a225-34f062572996_12337aa3-540a-4ea8-b631-3c14cdc6b38f.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "D-Glucitol, propoxylated",52625-13-5,"NOAEL (28 days repeated dose, Wistar): ≥ 1000 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f489490-a94f-4a8c-98c2-04fe6c4f5510/documents/IUC5-75e21e56-e60d-441a-ad41-0f094d06601a_b85d26fc-fa51-4092-9c7a-c7b04a49174b.html,,,,,, "D-Glucitol, propoxylated",52625-13-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f489490-a94f-4a8c-98c2-04fe6c4f5510/documents/IUC5-75e21e56-e60d-441a-ad41-0f094d06601a_b85d26fc-fa51-4092-9c7a-c7b04a49174b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, "D-Glucitol, propoxylated",52625-13-5,Acute toxicity via oral and dermal route were determined to be > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f489490-a94f-4a8c-98c2-04fe6c4f5510/documents/IUC5-54308d21-e597-4a4d-9365-0fedda5159c4_b85d26fc-fa51-4092-9c7a-c7b04a49174b.html,,,,,, "D-Glucitol, propoxylated",52625-13-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f489490-a94f-4a8c-98c2-04fe6c4f5510/documents/IUC5-54308d21-e597-4a4d-9365-0fedda5159c4_b85d26fc-fa51-4092-9c7a-c7b04a49174b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "D-Glucitol, propoxylated",52625-13-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f489490-a94f-4a8c-98c2-04fe6c4f5510/documents/IUC5-54308d21-e597-4a4d-9365-0fedda5159c4_b85d26fc-fa51-4092-9c7a-c7b04a49174b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts",742087-49-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74dd1261-fa35-4e08-9b9a-0b8cde807d72/documents/85472e9b-111b-4de7-9dd5-b9a2bfadfcf6_8379aa45-0289-45fc-87ea-b35d0227ae75.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "D-Glucopyranose, oligomeric, C10-16-alkyl glycosides, 2-hydroxy-3-sulfopropyl ethers, sodium salts",742087-49-6,"Acute oral toxicity LD50 > 2,000 mg/kg bw Acute dermal toxicity LD50 > 2,000 mg/kg bw (read-across) Acute inhalation toxicity LD50 study not scientifically justified ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74dd1261-fa35-4e08-9b9a-0b8cde807d72/documents/0cd369ce-2dea-4c80-8602-8323baf0b698_8379aa45-0289-45fc-87ea-b35d0227ae75.html,,,,,, Sodium Decylglucosides Hydroxypropyl Phosphate,740817-98-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b83ca3a-a488-4a79-816d-552143a2082e/documents/47509864-da00-46b2-8673-c5c0ad6b3854_9ec96ea5-8fe7-47b3-a0ae-5b9cb9ba37e9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "D-Glucopyranose, oligomeric, heptyl glycoside",1627851-18-6,"NOAEL (subacute, rat): 500 mg/kg bw/d for male and female ratsNOAEL (subchronic, rat): 1000 mg/kg bw/dNOAEL (subchronic, rat) ≥ 1000 mg/kg bw/day, based on read-across Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study (Klimisch score 2) from a reference substance with similar structure and intrinsic properties. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06735b5e-913b-4aca-98e3-c8459f9f5149/documents/IUC5-963624dd-2f65-4a8f-9515-370f0aa6626b_e17ee15f-77cb-45f8-8020-7beb431be798.html,,,,,, "D-Glucopyranose, oligomeric, heptyl glycoside",1627851-18-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06735b5e-913b-4aca-98e3-c8459f9f5149/documents/IUC5-963624dd-2f65-4a8f-9515-370f0aa6626b_e17ee15f-77cb-45f8-8020-7beb431be798.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "D-Glucopyranose, oligomeric, heptyl glycoside",1627851-18-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06735b5e-913b-4aca-98e3-c8459f9f5149/documents/IUC5-963624dd-2f65-4a8f-9515-370f0aa6626b_e17ee15f-77cb-45f8-8020-7beb431be798.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "D-Glucopyranose, oligomeric, heptyl glycoside",1627851-18-6,"Oral (OECD 423), rat (f): LD50 (cut-off) > 5000 mg/kg bw (limit test)Dermal (OECD 402), rat (m/f): LD50 > 2000 mg/kg bw (limit test), based on read-acrossDermal (PECD 402), rat (m/f): LD50>2000 mg/kg bw (limit test) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study (Klimisch score 2 due to read-across) from a reference substance with similar structure and intrinsic properties. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06735b5e-913b-4aca-98e3-c8459f9f5149/documents/IUC5-a2197bd7-eeff-4117-9ede-a56685e702d8_e17ee15f-77cb-45f8-8020-7beb431be798.html,,,,,, "D-Glucopyranose, oligomeric, heptyl glycoside",1627851-18-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06735b5e-913b-4aca-98e3-c8459f9f5149/documents/IUC5-a2197bd7-eeff-4117-9ede-a56685e702d8_e17ee15f-77cb-45f8-8020-7beb431be798.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "D-Glucopyranose, oligomeric, heptyl glycoside",1627851-18-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06735b5e-913b-4aca-98e3-c8459f9f5149/documents/IUC5-a2197bd7-eeff-4117-9ede-a56685e702d8_e17ee15f-77cb-45f8-8020-7beb431be798.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides",157707-87-4,"NOAEL (EU B.26, subchronic, rat) ≥ 1000 mg/kg bw/day, based on read-across ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c86b0fb5-5b5f-48c7-a935-9d9379d6ecf3/documents/IUC5-94072d37-8ad9-4081-9d97-f6aec5dbc11d_a3cf66c8-053c-4602-a0d8-e1e9cc42d723.html,,,,,, "D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides",157707-87-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c86b0fb5-5b5f-48c7-a935-9d9379d6ecf3/documents/IUC5-94072d37-8ad9-4081-9d97-f6aec5dbc11d_a3cf66c8-053c-4602-a0d8-e1e9cc42d723.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides",157707-87-4,"Oral (OECD 401), rat (m/f): LD50 > 2000 mg/kg bw (limit test)Dermal (OECD 402), rabbit (m/f): LD50 > 2000 mg/kg bw (limit test), based on read-across ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c86b0fb5-5b5f-48c7-a935-9d9379d6ecf3/documents/IUC5-002cc04b-2117-40d5-8cf3-9bd6dcbcc65e_a3cf66c8-053c-4602-a0d8-e1e9cc42d723.html,,,,,, "D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides",157707-87-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c86b0fb5-5b5f-48c7-a935-9d9379d6ecf3/documents/IUC5-002cc04b-2117-40d5-8cf3-9bd6dcbcc65e_a3cf66c8-053c-4602-a0d8-e1e9cc42d723.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "D-Glucopyranose, oligomers, branched and linear C9-11-alkyl glycosides",157707-87-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c86b0fb5-5b5f-48c7-a935-9d9379d6ecf3/documents/IUC5-002cc04b-2117-40d5-8cf3-9bd6dcbcc65e_a3cf66c8-053c-4602-a0d8-e1e9cc42d723.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "(2R,3S,4S)-2,3,4-tris(benzyloxy)-4-((R)-4-(benzyloxymethyl)-2,2-dimethyl-1,3-dioxotan-4-yl)-1-(4-methylpiperazin-1-yl)butan-1-one",1431329-07-5,"Oral:One 28-day study on rats is available which was conducted according to OECD 407 using rats (Beerens-Heijnen, 2015). The No Observed Adverse Effect Level (NOAEL) for the test substance was established to be 15 mg/kg. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a795a2bf-22a7-4b2c-a084-9f573330495c/documents/IUC5-68bd7a16-d8bb-4025-819b-d61d90d228f0_a9c9a533-e139-41e9-9bda-ed5cdadf8a58.html,,,,,, "(2R,3S,4S)-2,3,4-tris(benzyloxy)-4-((R)-4-(benzyloxymethyl)-2,2-dimethyl-1,3-dioxotan-4-yl)-1-(4-methylpiperazin-1-yl)butan-1-one",1431329-07-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a795a2bf-22a7-4b2c-a084-9f573330495c/documents/IUC5-68bd7a16-d8bb-4025-819b-d61d90d228f0_a9c9a533-e139-41e9-9bda-ed5cdadf8a58.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "(2R,3S,4S)-2,3,4-tris(benzyloxy)-4-((R)-4-(benzyloxymethyl)-2,2-dimethyl-1,3-dioxotan-4-yl)-1-(4-methylpiperazin-1-yl)butan-1-one",1431329-07-5,"Oral:One study is available (Latour, 2014). The oral LD50 value in Wistar rats was established to exceed 2000 mg/kg bodyweight.Inhalation:One study is available (van Huygevoort, 2014). The inhalatory LC 50, 4 h value in Wistar rats was established to exceed 5 mg/L.Dermal:One study is available (Latour, 2014). The dermal LD50 value in Wistar rats was established to exceed 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a795a2bf-22a7-4b2c-a084-9f573330495c/documents/IUC5-19193db1-69d5-4670-8037-be7c4af4d786_a9c9a533-e139-41e9-9bda-ed5cdadf8a58.html,,,,,, "(2R,3S,4S)-2,3,4-tris(benzyloxy)-4-((R)-4-(benzyloxymethyl)-2,2-dimethyl-1,3-dioxotan-4-yl)-1-(4-methylpiperazin-1-yl)butan-1-one",1431329-07-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a795a2bf-22a7-4b2c-a084-9f573330495c/documents/IUC5-19193db1-69d5-4670-8037-be7c4af4d786_a9c9a533-e139-41e9-9bda-ed5cdadf8a58.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "(2R,3S,4S)-2,3,4-tris(benzyloxy)-4-((R)-4-(benzyloxymethyl)-2,2-dimethyl-1,3-dioxotan-4-yl)-1-(4-methylpiperazin-1-yl)butan-1-one",1431329-07-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a795a2bf-22a7-4b2c-a084-9f573330495c/documents/IUC5-19193db1-69d5-4670-8037-be7c4af4d786_a9c9a533-e139-41e9-9bda-ed5cdadf8a58.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "(2R,3S,4S)-2,3,4-tris(benzyloxy)-4-((R)-4-(benzyloxymethyl)-2,2-dimethyl-1,3-dioxotan-4-yl)-1-(4-methylpiperazin-1-yl)butan-1-one",1431329-07-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a795a2bf-22a7-4b2c-a084-9f573330495c/documents/IUC5-19193db1-69d5-4670-8037-be7c4af4d786_a9c9a533-e139-41e9-9bda-ed5cdadf8a58.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Di(µ-2,2´,2´´-nitrilotris(ethanol)-diperchlorato)dinatrium",156157-97-0," NOAEL (oral) = 1.0 mg/kg bw/day (perchlorate, rat) NOAEL (dermal, systemic effects) = 250 mg/kg bw/day (triethanolamine, rat) NOAEL (dermal, local effects) = 125 mg/kg bw/day (triethanolamine, rat) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6a10e06-3d3f-4294-a73a-5dfdb4463d2a/documents/b3e7b445-c686-422c-9264-3cd2c7edb837_4840f678-ac6c-4a07-a0be-f09c72460f52.html,,,,,, "Di(µ-2,2´,2´´-nitrilotris(ethanol)-diperchlorato)dinatrium",156157-97-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6a10e06-3d3f-4294-a73a-5dfdb4463d2a/documents/b3e7b445-c686-422c-9264-3cd2c7edb837_4840f678-ac6c-4a07-a0be-f09c72460f52.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,1 mg/kg bw/day,,rat "Di(µ-2,2´,2´´-nitrilotris(ethanol)-diperchlorato)dinatrium",156157-97-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6a10e06-3d3f-4294-a73a-5dfdb4463d2a/documents/b3e7b445-c686-422c-9264-3cd2c7edb837_4840f678-ac6c-4a07-a0be-f09c72460f52.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,250 mg/kg bw/day,,rat "Di(µ-2,2´,2´´-nitrilotris(ethanol)-diperchlorato)dinatrium",156157-97-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6a10e06-3d3f-4294-a73a-5dfdb4463d2a/documents/b3e7b445-c686-422c-9264-3cd2c7edb837_4840f678-ac6c-4a07-a0be-f09c72460f52.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.7 mg/cm2,adverse effect observed,rat "Di(µ-2,2´,2´´-nitrilotris(ethanol)-diperchlorato)dinatrium",156157-97-0, LD50 (oral) > 2000 mg/kg b.w. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6a10e06-3d3f-4294-a73a-5dfdb4463d2a/documents/ce4bd662-fd5b-483f-bf12-f3000694a550_4840f678-ac6c-4a07-a0be-f09c72460f52.html,,,,,, "Di(µ-2,2´,2´´-nitrilotris(ethanol)-diperchlorato)dinatrium",156157-97-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6a10e06-3d3f-4294-a73a-5dfdb4463d2a/documents/ce4bd662-fd5b-483f-bf12-f3000694a550_4840f678-ac6c-4a07-a0be-f09c72460f52.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Di(morpholin-4-yl) disulphide,103-34-4,"In a 90-day inhalation study (OECD 412), the NOAEC (No-Observed-Adverse-Effect-Concentration) for local effects was considered to be 0.507 mg 4,4’-Dithiodimorpholine/m3 air based on the effects observed in the larynx. The NOAEC for systemic effects was considered to be 8.38 mg 4,4’-Dithiodimorpholine/m3 air. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb7b68a1-b2f6-4c8e-9652-b4b2a29b809b/documents/IUC5-a6de54fc-2a8f-435f-99e1-b2d21101e824_185af9d6-0b4e-4c75-a5e0-a30392676eb0.html,,,,,, Di(morpholin-4-yl) disulphide,103-34-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb7b68a1-b2f6-4c8e-9652-b4b2a29b809b/documents/IUC5-a6de54fc-2a8f-435f-99e1-b2d21101e824_185af9d6-0b4e-4c75-a5e0-a30392676eb0.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,8.38 mg/m3,,rat Di(morpholin-4-yl) disulphide,103-34-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb7b68a1-b2f6-4c8e-9652-b4b2a29b809b/documents/IUC5-a6de54fc-2a8f-435f-99e1-b2d21101e824_185af9d6-0b4e-4c75-a5e0-a30392676eb0.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.507 mg/m3,adverse effect observed,rat Di(morpholin-4-yl) disulphide,103-34-4,"4,4'-dithiodimorpholine is of low acute toxicity by the oral and dermal routes. In rats, the acute oral LD50 is 5600 mg/kg and the acute dermal LD0 is higher than 2000 mg/kg. Na data is available by inhalation. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb7b68a1-b2f6-4c8e-9652-b4b2a29b809b/documents/IUC5-1cf871ac-92d9-468e-aacc-c1c2cb2bc5cf_185af9d6-0b4e-4c75-a5e0-a30392676eb0.html,,,,,, Di(morpholin-4-yl) disulphide,103-34-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb7b68a1-b2f6-4c8e-9652-b4b2a29b809b/documents/IUC5-1cf871ac-92d9-468e-aacc-c1c2cb2bc5cf_185af9d6-0b4e-4c75-a5e0-a30392676eb0.html,,oral,LD50,"5,600 mg/kg bw",adverse effect observed, Di(morpholin-4-yl) disulphide,103-34-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb7b68a1-b2f6-4c8e-9652-b4b2a29b809b/documents/IUC5-1cf871ac-92d9-468e-aacc-c1c2cb2bc5cf_185af9d6-0b4e-4c75-a5e0-a30392676eb0.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Di(tetraethylammonium)hexahydroxoplatinate(IV),1912392-88-1,"No repeated dose toxicity study with HHPA-TEAH is available, thus the repeated dose toxicity is addressed with existing data on HHPA and TEAH as detailed in the ‘HHPA-TEAH ReadAcross justification’ document (Section 13.2).  For the purpose of hazard assessment of HHPA-TEAH, the point of departure for the most sensitive endpoint of each constituent will be used for the DNEL derivation.     ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93520e6d-a8ad-448c-83a0-d0c7fe6e56a8/documents/81716685-f929-49e3-9f19-d044f53f5d34_e825745e-4fa5-4782-8adf-ce44f9d82bfc.html,,,,,, Di(tetraethylammonium)hexahydroxoplatinate(IV),1912392-88-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93520e6d-a8ad-448c-83a0-d0c7fe6e56a8/documents/81716685-f929-49e3-9f19-d044f53f5d34_e825745e-4fa5-4782-8adf-ce44f9d82bfc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Di(tetraethylammonium)hexahydroxoplatinate(IV),1912392-88-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93520e6d-a8ad-448c-83a0-d0c7fe6e56a8/documents/81716685-f929-49e3-9f19-d044f53f5d34_e825745e-4fa5-4782-8adf-ce44f9d82bfc.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rat Di(tetraethylammonium)hexahydroxoplatinate(IV),1912392-88-1," No relevant acute oral, dermal or inhalation toxicity data were identified. However, acute toxicity testing is not considered appropriate as di(tetraethylammonium)hexahydroxoplatinate is classified as corrosive to the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93520e6d-a8ad-448c-83a0-d0c7fe6e56a8/documents/f8c35877-6ba6-44bb-a57b-da749a56b71e_e825745e-4fa5-4782-8adf-ce44f9d82bfc.html,,,,,, Diacetoxydi-tert-butoxysilane,13170-23-5," Weight of evidence: Based on experimental results obtained in repeated dose toxicity studies with supporting substances acetic acid and sodium acetate, read-across approach was applied and the NOAEL (28 days in rats) for diacetoxydi-tert-butoxysilane was calculated to be greater than 6416.41 mg/kg bw/day (based on no effects observed at the highest dose). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bafc06d-f6c4-491d-91a5-11033d0a2988/documents/IUC5-beadbeeb-95f4-4483-a69a-90c636e2251e_1bc01888-c71f-4dfa-8742-245aa9e147c9.html,,,,,, Diacetoxydi-tert-butoxysilane,13170-23-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bafc06d-f6c4-491d-91a5-11033d0a2988/documents/IUC5-beadbeeb-95f4-4483-a69a-90c636e2251e_1bc01888-c71f-4dfa-8742-245aa9e147c9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"6,416.41 mg/kg bw/day",,rat Diacetoxydi-tert-butoxysilane,13170-23-5," Acute toxicity (oral): Data waiving ( study scientifically not necessary): In accordance with column 2 of REACH Annex VIII, the study does not to be conducted since the substance is classified as corrosive to the skin. Acute toxicity (inhalation): Data waiving ( study scientifically not necessary): In accordance with column 2 of REACH Annex VIII, the study does not to be conducted since the substance is classified as corrosive to the skin. Acute toxicity (dermal): Data waiving ( study scientifically not necessary): In accordance with column 2 of REACH Annex VIII, the study does not to be conducted since the substance is classified as corrosive to the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bafc06d-f6c4-491d-91a5-11033d0a2988/documents/IUC5-fea7aab3-377f-4fd3-b778-af42cb2ba678_1bc01888-c71f-4dfa-8742-245aa9e147c9.html,,,,,, "Diallyl 2,2'-oxydiethyl dicarbonate",142-22-3,"Key, rat, oral, OECD 408, GLP, NOAEL = 25 mg/kg bw/d Key, rat, dermal, OECD 422, GLP, NOAEL > 1030 mg/kg bw/d ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a32f5c5-062a-4118-a23d-7975773cb844/documents/IUC5-253902bf-ad53-445b-bc65-8be63eb3960a_a2ee4601-7c90-4e35-b816-0439d2a15cc4.html,,,,,, "Diallyl 2,2'-oxydiethyl dicarbonate",142-22-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a32f5c5-062a-4118-a23d-7975773cb844/documents/IUC5-253902bf-ad53-445b-bc65-8be63eb3960a_a2ee4601-7c90-4e35-b816-0439d2a15cc4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat "Diallyl 2,2'-oxydiethyl dicarbonate",142-22-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a32f5c5-062a-4118-a23d-7975773cb844/documents/IUC5-253902bf-ad53-445b-bc65-8be63eb3960a_a2ee4601-7c90-4e35-b816-0439d2a15cc4.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,030 mg/kg bw/day",,rat "Diallyl 2,2'-oxydiethyl dicarbonate",142-22-3,"Acute toxicity: oral: Wil Research Laboratories, Inc. Acute Oral Toxicity Study in Albino Rats with CR-39 (479-768) (1981); GLP; comparable to the OECD Guideline 401. Acute toxicity: dermal: Wil Research Laboratories, Inc. Acute Dermal Toxicity Study in Albino Rabbits with CR-39 (1981); comparable to the OECD Guideline 402. Acute toxicity: inhalation: Industrial BIO-TEST Laboratories, Inc. Acute vapor inhalation toxicity study with CR-39, 62310-31-151-1006 in albino rats (1971); comparable to the OECD Guideline 403.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a32f5c5-062a-4118-a23d-7975773cb844/documents/IUC5-dddc7091-d55f-4510-9f27-0ecfb1142a62_a2ee4601-7c90-4e35-b816-0439d2a15cc4.html,,,,,, "Diallyl 2,2'-oxydiethyl dicarbonate",142-22-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a32f5c5-062a-4118-a23d-7975773cb844/documents/IUC5-dddc7091-d55f-4510-9f27-0ecfb1142a62_a2ee4601-7c90-4e35-b816-0439d2a15cc4.html,,oral,LD50,515 mg/kg bw,adverse effect observed, "Diallyl 2,2'-oxydiethyl dicarbonate",142-22-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a32f5c5-062a-4118-a23d-7975773cb844/documents/IUC5-dddc7091-d55f-4510-9f27-0ecfb1142a62_a2ee4601-7c90-4e35-b816-0439d2a15cc4.html,,dermal,LD50,"11,430 mg/kg bw",no adverse effect observed, "Diallyl 2,2'-oxydiethyl dicarbonate",142-22-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a32f5c5-062a-4118-a23d-7975773cb844/documents/IUC5-dddc7091-d55f-4510-9f27-0ecfb1142a62_a2ee4601-7c90-4e35-b816-0439d2a15cc4.html,,inhalation,discriminating conc.,365 mg/m3,no adverse effect observed, Diallyl hexahydrophthalate,13846-31-6, The NOAEL for Systemic toxicity for the adults was considered to be 100 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a16a42ac-6cb7-48c9-a8ea-b000cd4bef5f/documents/a6b5ab33-7e41-440e-aec4-3002ff8b9292_79e7473b-e858-4fc9-8acc-bbcbbf60a1d9.html,,,,,, Diallyl hexahydrophthalate,13846-31-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a16a42ac-6cb7-48c9-a8ea-b000cd4bef5f/documents/a6b5ab33-7e41-440e-aec4-3002ff8b9292_79e7473b-e858-4fc9-8acc-bbcbbf60a1d9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Diallyl hexahydrophthalate,13846-31-6," The acute oral LD50 value of MDAC was found to be equal or above 2000 mg/kg bw in female Crl:WI Wistar rats. According the CLP criteria, MDAC is not classified for acute oral exposure. The acute dermal median lethal dose (LD50) of the test item MDAC was found to be greater than 2000 mg/kg body weight in male and female Crl:WI rats. According to the GHS criteria. MDAC can be ranked as ""Unclassified"" for acute dermal exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a16a42ac-6cb7-48c9-a8ea-b000cd4bef5f/documents/912a7c3c-643c-4b8e-95f8-48d9ee7919c5_79e7473b-e858-4fc9-8acc-bbcbbf60a1d9.html,,,,,, Diallyl hexahydrophthalate,13846-31-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a16a42ac-6cb7-48c9-a8ea-b000cd4bef5f/documents/912a7c3c-643c-4b8e-95f8-48d9ee7919c5_79e7473b-e858-4fc9-8acc-bbcbbf60a1d9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Diallyl hexahydrophthalate,13846-31-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a16a42ac-6cb7-48c9-a8ea-b000cd4bef5f/documents/912a7c3c-643c-4b8e-95f8-48d9ee7919c5_79e7473b-e858-4fc9-8acc-bbcbbf60a1d9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Diallyl isophthalate,1087-21-4, Information is only available for repeated oral dose toxicity. No data is available for dermal toxicity or toxicity through inhalation. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2c7041d-3aef-4252-9fa4-6efce7c95469/documents/5eaf9ea7-836b-4c29-9747-0064fd1fb436_c53c65c0-052a-4461-b4ad-0a069ccd27a5.html,,,,,, Diallyl isophthalate,1087-21-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2c7041d-3aef-4252-9fa4-6efce7c95469/documents/5eaf9ea7-836b-4c29-9747-0064fd1fb436_c53c65c0-052a-4461-b4ad-0a069ccd27a5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Diallyl isophthalate,1087-21-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): In an acute inhalation study in the rat a LC50 of 8.3 mg/L = 8300 mg/m3 for a 1 hour exposure was identified (SIDS 1982). The LC1 of 580 mg/m3 was calculated by the authors and this is the basis for deriving the DNEL since it is the most sensitive starting point. Another acute inhalation study identified a LC100 of 4470 mg/m3 for a 4 hour exposure (FMC, 1980). It is proposed to use the LC1 of 580 mg/m3 to derive the DNEL since the appropriate LC50 has been estimated. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2c7041d-3aef-4252-9fa4-6efce7c95469/documents/IUC5-9faade2b-ec91-4630-a52d-16d4205b155a_c53c65c0-052a-4461-b4ad-0a069ccd27a5.html,,,,,, Diallyl isophthalate,1087-21-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2c7041d-3aef-4252-9fa4-6efce7c95469/documents/IUC5-9faade2b-ec91-4630-a52d-16d4205b155a_c53c65c0-052a-4461-b4ad-0a069ccd27a5.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Diallyl isophthalate,1087-21-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2c7041d-3aef-4252-9fa4-6efce7c95469/documents/IUC5-9faade2b-ec91-4630-a52d-16d4205b155a_c53c65c0-052a-4461-b4ad-0a069ccd27a5.html,,dermal,LD50,"3,300 mg/kg bw",no adverse effect observed, Diallyl isophthalate,1087-21-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2c7041d-3aef-4252-9fa4-6efce7c95469/documents/IUC5-9faade2b-ec91-4630-a52d-16d4205b155a_c53c65c0-052a-4461-b4ad-0a069ccd27a5.html,,inhalation,discriminating conc.,580 mg/m3,no adverse effect observed, Diallyl phthalate,131-17-9, Information is only available for repeated oral dose toxicity. No data is available for dermal toxicity or toxicity through inhalation. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9cbf139b-ad3c-46c0-bf25-a92decfccdee/documents/IUC5-82101113-542e-462a-af4c-054af6aad9f2_91a086b4-cc7b-4530-9289-189bd741f990.html,,,,,, Diallyl phthalate,131-17-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9cbf139b-ad3c-46c0-bf25-a92decfccdee/documents/IUC5-82101113-542e-462a-af4c-054af6aad9f2_91a086b4-cc7b-4530-9289-189bd741f990.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Diallyl phthalate,131-17-9," DAP exhibits low to moderate acute oral and inhalation toxicity, with low acute dermal toxicity in rodents. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9cbf139b-ad3c-46c0-bf25-a92decfccdee/documents/IUC5-e2974e42-5f00-46b9-9057-10e9411749ea_91a086b4-cc7b-4530-9289-189bd741f990.html,,,,,, Diallyl phthalate,131-17-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9cbf139b-ad3c-46c0-bf25-a92decfccdee/documents/IUC5-e2974e42-5f00-46b9-9057-10e9411749ea_91a086b4-cc7b-4530-9289-189bd741f990.html,,oral,LD50,656 mg/kg bw,no adverse effect observed, Diallyl phthalate,131-17-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9cbf139b-ad3c-46c0-bf25-a92decfccdee/documents/IUC5-e2974e42-5f00-46b9-9057-10e9411749ea_91a086b4-cc7b-4530-9289-189bd741f990.html,,dermal,LD50,"3,300 mg/kg bw",no adverse effect observed, Diallyl phthalate,131-17-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9cbf139b-ad3c-46c0-bf25-a92decfccdee/documents/IUC5-e2974e42-5f00-46b9-9057-10e9411749ea_91a086b4-cc7b-4530-9289-189bd741f990.html,,inhalation,discriminating conc.,580 mg/m3,no adverse effect observed, Diallylamine,124-02-7," Repeat dose toxicity - oral (OECD 422): The oral administration of Diallylamine to rats for a period of up to eight weeks (including two weeks pre-pairing, gestation and early lactation for females) at dose levels of 15, 30 and 75 mg/kg bw/day did not result in any toxicologically significant effects. Episodes of increased salivation were reported in animals of either sex treated with 75 mg/kg bw/day from Day 9 (males) and Day 13 (females) onwards. An increase in overall water consumption was also observed for females treated with 75 and 30 mg/kg bw/day. Observations of this nature are commonly observed following the oral administration of an unpalatable test item formulation and in isolation are generally regarded as not an adverse effect of systemic toxicity. Initial reductions/losses in body weight gain were evident in animals of either sex treated with 75 mg/kg bw/day and in males treated with 30 mg/kg bw/day which was associated with reduced food consumption at 75 mg/kg bw/day, however subsequent recovery was evident in all animals and body weight gains which, in subsequent weeks for treated males were actually higher than control males. Due to the initial effect on body weight development in males treated with 75 mg/kg bw/day, overall body weight gains for this group was lower than controls. Based on the overall effect on body weight performance together with the clear evidence of recovery, these findings were deemed not to be of an adverse nature. Although there were some statistically significant differences in treated animals from controls for the blood chemical parameters measured, in the absence of any related microscopic changes these differences were considered not to be of toxicological significance. No treatment-related macroscopic abnormalities were evident in treated animals however microscopic examination revealed changes in the adrenal gland (hypertrophy of the zona glomerulosa) of animals of either sex treated with 75 and 15 mg/kg bw/day and in one female treated with 30 mg/kg bw/day. Zona glomerulosa hypertrophy in the adrenal gland is seen occasionally in toxicology studies and whilst the significance is not clear, it is linked to hydration and electrolyte balance and is therefore seen as an adaptive response. Due to the low incidence, lack of dose response and limited number of animals per group it is considered that, within the confines of this study the change may reflect a variation in background levels, particularly in lactating females and cannot be unequivocally related to the administration of the test item and not considered to be an adverse event. Microscopic examination of the kidneys revealed increased hyaline droplets in males treated with 75 mg/kg bw/day. Kidney weights were also elevated in these males. Hyaline droplets can be directly linked to the accumulation of alpha 2u-globulin, which is unique to the male rat. This finding is not found in immature rats, female rats or humans and therefore is considered to be of no relevance to man. Therefore, a ‘No Observed Adverse Effect Level’ (NOAEL) for males can be established based on the observed effects excluding those related to alpha 2u-globulin nephropathy. The oral administration of Diallylamine to rats by gavage, at dose levels of 15, 30 and 75 mg/kg bw/day, did not result in any significant toxicological effects. The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 75 mg/kg bw/day for either sex. Repeat dose toxicity - inhalation: Male rats were exposed to 0, 25, 50, 100 or 200 ppm of diallylamine vapour for seven hours/day for 50 days in order to assess cardiac and other organ system toxicity. Reported effects at 200 ppm: 30% mortality; elevated heart, liver, kidney and lung / w ratios; decreased bw gain; microscopically, heart lesions were found in 11 of 15 rats. The No Observed Effect Level (NOEL) was considered to be 25 ppm based on the absence of any effects at this level. The No Observed Adverse Effect level (NOAEL) was considered to be in the range of 50 -100 ppm based on the absence of cardiac lesions at these levels, but there was an elevated heart to bodyweight ratio. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37149d1f-8b2c-41fe-bfd0-8171cbdae13e/documents/66e2e596-7b95-4f66-8446-1b4c7fefc804_8a95d294-3c56-4338-aa3e-c5d3d4505c7a.html,,,,,, Diallylamine,124-02-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37149d1f-8b2c-41fe-bfd0-8171cbdae13e/documents/66e2e596-7b95-4f66-8446-1b4c7fefc804_8a95d294-3c56-4338-aa3e-c5d3d4505c7a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat Diallylamine,124-02-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37149d1f-8b2c-41fe-bfd0-8171cbdae13e/documents/66e2e596-7b95-4f66-8446-1b4c7fefc804_8a95d294-3c56-4338-aa3e-c5d3d4505c7a.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,400 mg/m3,,rat Diallylamine,124-02-7," Acute oral toxicity: Key data: Female Sprague-Dawley rats were administered, by gavage, a single dose of diallylamine at 215, 464, 1000 and 4640 mg/kg. No observable effects occurred at the lowest tested dose, while mortality was induced at higher doses within 20 hours of dosing. In the same study, male Sprague-Dawley rats administered diallylamine at 215, 464, 1000 and 2150 mg/kg exhibited a dose-dependent depression (lethargy) in all exposed groups. At lower doses, death sometimes occurred a week or later after dosing, while at 1000 mg/kg and higher, all male rats died within 2 hours. Based on the results of the study the following LD50 values were reported: 316 mg/k for males and 501 mg/kg for females. Weight of evidence data: Male rats were administered, by gavage, a sinlge dose of diallylamine at dose levels 267 - 600 mg/kg. The acute oral LD50 was reported as 578 mg/kg. Acute dermal toxicity: Key data: Diallylamine was applied for 24 hours to the intact skin of New Zealand white rabbits, at doses of 215, 464, 1000 and 2150 mg/kg. Necrosis, erythema and edema were observed. Mortality data are as follows: 215 mg/kg (0/4), 464 mg/kg (1/4), 1000 mg/kg (4/4) and 2150 mg/kg (4/4). All deaths occured within 24 hours of dosing, most in less than 4 hours. The LD50 was reported as 562 mg/kg. Weight of evidence data: Male rabbits (3 per group) were administered a single dose of diallylamine for several hours under a patch, at dose levels of 100 - 800 mg/kg. The acute dermal LD50 was reported as 356 mg/kg. Substantial local redness, swelling and scarring of skin was observed. Acute inhalation toxicity: Key data: The actue inhalation toxicity of diallylamine was examined by exposure (vapour) to rats for 1, 4 and 8 hours. Rats were exposed to diallylamine (vapour) for 1, 4 and 8 hours. The tested concentrations were: 1 hour exposure: 7000 ppm (27.8 mg/L) 4 hour exposure: 1500 - 5070 ppm (5.96 mg/L - 20.15 mg/L). 8 hour exposure: 450 - 1500 ppm (0.45 - 5.96 mg/L) The following results are reported: A 4-hour rat LC50 of 10.95 mg/L is reported. No mortalities were observed after the 1 hour exposure and a 1 hour LC50 of 27.8 mg/L is reported. This converts to a 4 hour LC50 estimate of 13.9 mg/L. A 8-hour LC50 of 3.16 mg/L is reported. This converts to a 4 hour LC50 estimate of 4.47 mg/L Weight of evidence data: 10 Rats (5 male and 5 female) were exposed to diallylamine (vapour) for 1 hour at a test concentration of 6.3 mg/l and observed for 14 days. No deaths occured. Moderate eye irritation and depression (lethargy) were observed during exposure and persisted after cessation of treatment, but rats appeared normal after 24 hours. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37149d1f-8b2c-41fe-bfd0-8171cbdae13e/documents/7bf4fc17-f307-49e7-ab3e-2240ab301303_8a95d294-3c56-4338-aa3e-c5d3d4505c7a.html,,,,,, Diallylamine,124-02-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37149d1f-8b2c-41fe-bfd0-8171cbdae13e/documents/7bf4fc17-f307-49e7-ab3e-2240ab301303_8a95d294-3c56-4338-aa3e-c5d3d4505c7a.html,,oral,LD50,316 mg/kg bw,adverse effect observed, Diallylamine,124-02-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37149d1f-8b2c-41fe-bfd0-8171cbdae13e/documents/7bf4fc17-f307-49e7-ab3e-2240ab301303_8a95d294-3c56-4338-aa3e-c5d3d4505c7a.html,,dermal,LD50,562 mg/kg bw,adverse effect observed, Diallylamine,124-02-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37149d1f-8b2c-41fe-bfd0-8171cbdae13e/documents/7bf4fc17-f307-49e7-ab3e-2240ab301303_8a95d294-3c56-4338-aa3e-c5d3d4505c7a.html,,inhalation,LC50,"10,950 mg/m3",adverse effect observed, Dialuminium nickel tetraoxide,12004-35-2,"ORAL: Data are read-across from Ni sulfate. A 2-year oral carcinogenicity study reported a NOAEL of 10 mg/kg body weight/day (2.2 mg Ni/kg b. w. /day) and a LOAEL of 30 mg/kg body weight/day (6.7 mg Ni/kg b. w. /day) (Heim et al. 2007). The LOAEL of 6.7 mg Ni/kg bw/day based on reduced body weight and increased mortality together with a NOAEL of 2.2 mg Ni/kg bw/day is taken forward to the risk characterisation. A comprehensive summary document on this topic is provided as a backgound document in the Appendixof the CSR.INHALATION: Exposure related toxicities were noted following 13 weeks or two years of exposure to NiO (Dunnick et al. 1989, NTP, 1996) in both rats and mice. Adverse effects in rodents were primarily limited to the lung (e. g., increased tissue weight, inflammation, macrophage hyperplasia) The LOAEC from the corresponding chronic study was 0.6 mg NiO/m3 or 0.5 mg Ni/m3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ce5b360-f2e3-4936-9bf7-900f8c39bf02/documents/IUC5-de98065e-9e99-41e0-a653-b2941ede7904_d99ad9ff-ba75-45e2-b7b5-f002ac864818.html,,,,,, Dialuminium nickel tetraoxide,12004-35-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ce5b360-f2e3-4936-9bf7-900f8c39bf02/documents/IUC5-de98065e-9e99-41e0-a653-b2941ede7904_d99ad9ff-ba75-45e2-b7b5-f002ac864818.html,Chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Dialuminium nickel tetraoxide,12004-35-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ce5b360-f2e3-4936-9bf7-900f8c39bf02/documents/IUC5-de98065e-9e99-41e0-a653-b2941ede7904_d99ad9ff-ba75-45e2-b7b5-f002ac864818.html,Chronic toxicity – systemic effects,inhalation,LOAEC,0.5 mg/m3,,rat Dialuminium nickel tetraoxide,12004-35-2,"Oral:LD50 > 2000 g/kg bw nickel aluminateLD50 cut-off > 5000 g/kg bw nickel aluminateRead-across from nickel oxide:ORAL: A series of recent studies conducted by Eurofins Product Safety Laboratory (EPSL) characterized the acute oral LD50 of both black and green nickel oxides in rats. Based on the acute toxicity up and down procedure (carried out according to OECD Test # 425 guidelines and using GLP standards), the acute oral LD50 was found to be greater than 11,000 mg/kg for nickel oxide green and equal to 9,990 mg/kg for nickel oxide black.INHALATION: Two guideline-based studies conducted in rats, reported an LC50 greater than 5.08 mg/L for nickel oxide green and greater than 5.15 mg/L for nickel oxide black, in male and female rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ce5b360-f2e3-4936-9bf7-900f8c39bf02/documents/IUC5-364a73ad-2704-433d-950d-0aaccc8ae620_d99ad9ff-ba75-45e2-b7b5-f002ac864818.html,,,,,, "Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)-3,4,5,6-tetrachlorobenzoate]",15876-58-1," Prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for the test compound Di aluminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)-3,4,5,6-tetrachlorobenzoate]. The study assumed the use of male and female Wistar. The females were treated for 49 days and males for 35 days. No significant alterations were noted at the mentioned dose level. The predicted No Observed Adverse Effect Level (NOAEL) for Di aluminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)-3,4,5,6-tetrachlorobenzoate] is considered to be 620.0 mg/Kg bw/day.Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb2ae8b7-a84f-4b4f-be63-c3559e9d117c/documents/0da6a821-26e1-49ac-903a-f4d97b961b0d_a9abdd02-8d54-4112-8e06-e921a0c762aa.html,,,,,, "Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)-3,4,5,6-tetrachlorobenzoate]",15876-58-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb2ae8b7-a84f-4b4f-be63-c3559e9d117c/documents/0da6a821-26e1-49ac-903a-f4d97b961b0d_a9abdd02-8d54-4112-8e06-e921a0c762aa.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,620 mg/kg bw/day,,rat "Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)-3,4,5,6-tetrachlorobenzoate]",15876-58-1," Acute oral toxicity: The acute oral LD50 (Cut-off value) of Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)-3,4,5,6 -tetrachlorobenzoate] (CAS No. 15876-58-1) was 5000 mg/kg body weight. Thus, it was concluded that the acute toxicity study of Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)-3,4,5,6-tetrachlorobenzoate] (CAS No. 15876-58-1), when administered via oral route in Sprague Dawley rats considered to be ""Not classified"" as per the CLP regulation. Acute inhalation toxicity: The study need not to be conducted because exposure of human via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size – (exposure considerations) Acute dermal toxicity: It was concluded that the acute dermal median lethal dose (LD50) of Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)-3,4,5,6-tetrachlorobenzoate] (CAS No. 15876-58-1), when administered to male and female Sprague Dawley rats was found to be greater than 2000 mg/kg body weight. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)-3,4,5,6-tetrachlorobenzoate] (CAS No. 15876-58-1) does not classify as an acute dermal toxicant.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb2ae8b7-a84f-4b4f-be63-c3559e9d117c/documents/IUC5-992b13ee-9c39-4771-aab9-cb0dd6f4f5fe_a9abdd02-8d54-4112-8e06-e921a0c762aa.html,,,,,, "Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)-3,4,5,6-tetrachlorobenzoate]",15876-58-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb2ae8b7-a84f-4b4f-be63-c3559e9d117c/documents/IUC5-992b13ee-9c39-4771-aab9-cb0dd6f4f5fe_a9abdd02-8d54-4112-8e06-e921a0c762aa.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Dialuminium tris[2-(2,4,5,7-tetrabromo-6-oxido-3-oxoxanthen-9-yl)-3,4,5,6-tetrachlorobenzoate]",15876-58-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb2ae8b7-a84f-4b4f-be63-c3559e9d117c/documents/IUC5-992b13ee-9c39-4771-aab9-cb0dd6f4f5fe_a9abdd02-8d54-4112-8e06-e921a0c762aa.html,,dermal,LD50,"2,000 mg/kg bw",, Dialuminium tris[4-hydroxy-3-[(4-sulphonato-1-naphthyl)azo]naphthalenesulphonate],84041-67-8, LD50 was estimated to be 6543mg/kg bw when rats were exposed with Dialuminium tris(4-hydroxy-3-((4-sulphonato-1-naphthyl)azo)naphthalenesulphonate) orally. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ec94a9a-9a0c-4247-826a-8eb1b5b6a30b/documents/478378aa-6108-4df4-b29a-8df5639fafe1_9ffa5eb7-7b9c-456c-9fe1-3ecbb234de61.html,,,,,, Dialuminium tris[4-hydroxy-3-[(4-sulphonato-1-naphthyl)azo]naphthalenesulphonate],84041-67-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ec94a9a-9a0c-4247-826a-8eb1b5b6a30b/documents/478378aa-6108-4df4-b29a-8df5639fafe1_9ffa5eb7-7b9c-456c-9fe1-3ecbb234de61.html,,oral,LD50,"6,543 mg/kg bw",no adverse effect observed, Diaminotoluene,25376-45-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6b90714-bd17-4545-aa1c-38d40ae08099/documents/IUC5-bcf9e8f4-f708-491b-8cff-2b5942dedfe2_9cccd9f0-ce77-4e15-bb2c-14ba92a7ae87.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,5.9 mg/kg bw/day,, Diaminotoluene,25376-45-8,"Regarding results obtained for the mixed TDA and 2,4-TDA. It is necessary to make distinction between these two susbtances to evaluate the acute toxicity effects. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6b90714-bd17-4545-aa1c-38d40ae08099/documents/IUC5-e33df4cd-dc3e-4736-a462-30ecaec32106_9cccd9f0-ce77-4e15-bb2c-14ba92a7ae87.html,,,,,, Diamminedichloropalladium,14323-43-4," In an OECD Test Guideline 422 combined repeated dose toxicity study and reproductive/developmental toxicity screening study, to GLP, diamminedichloropalladium was administered to rats at dietary concentrations of 1500, 4500 and 12000 ppm (equivalent to doses of around 121, 373 and 831 mg/kg bw/day, respectively) for at least 28 days. A NOAEL of 373 mg/kg bw/day for general systemic toxicity was determined, due to the marked body weight loss observed at the highest tested dose (a consequence of reduced food consumption) (Török-Bathó, 2015). The critical oral NOAEL for diamminedichloropalladium (373 mg/kg bw/day) equates to an NOAEL of 188 mg/kg bw/day for palladium (based on MWt ratio). No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/695f25b5-acca-4878-b3a1-c3ad889b31db/documents/IUC5-480aea1b-a5ea-4b61-b56a-f3c25831ed39_d7898e9b-b726-4ee6-9692-c1472a77c175.html,,,,,, Diamminedichloropalladium,14323-43-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/695f25b5-acca-4878-b3a1-c3ad889b31db/documents/IUC5-480aea1b-a5ea-4b61-b56a-f3c25831ed39_d7898e9b-b726-4ee6-9692-c1472a77c175.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,373 mg/kg bw/day,,rat Diamminedichloropalladium,14323-43-4," In an OECD Test Guideline 423 study, to GLP, the acute oral LD50 of diamminedichloropalladium was determined to be between 300 and 2000 mg/kg bw (Robertson, 2012). In an OECD Test Guideline 402 study, to GLP, there were no deaths over a 2-week observation period following application of neat diamminedichloropalladium for 24 hours under occlusion at a limit dose of 2000 mg/kg bw to the skin of groups of 5 male and 5 female rats (Kiss, 2012a). No relevant acute inhalation toxicity data were identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/695f25b5-acca-4878-b3a1-c3ad889b31db/documents/IUC5-b25b8bcd-38f8-4ff1-a262-76747d9850af_d7898e9b-b726-4ee6-9692-c1472a77c175.html,,,,,, Diamminedichloropalladium,14323-43-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/695f25b5-acca-4878-b3a1-c3ad889b31db/documents/IUC5-b25b8bcd-38f8-4ff1-a262-76747d9850af_d7898e9b-b726-4ee6-9692-c1472a77c175.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Diamminediisocyanatozinc,122012-52-6," Subacute (28d) study, GLP, Sprague-Dawley rats, m/f, 0, 1, 20, 400 mg/kg, oral (gavage): NOEL = 20 mg/kg Subchronic (13 week) study, OECD 408, GLP, Sprague-Dawley CD rats, m/f, 10/sex/group + recovery, 0, 1, 10, 100 mg/kg in corn oil, oral (gavage): NOAEL = 10 mg/kg (males), NOEL = 10 mg/kg (females) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc69e911-10c7-4f98-87e5-ea14f805557d/documents/7a598e21-6943-444a-bd6e-7327b9aa4618_e7397fbd-258b-4ea6-a4f2-48d5ff1d5e4d.html,,,,,, Diamminediisocyanatozinc,122012-52-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc69e911-10c7-4f98-87e5-ea14f805557d/documents/7a598e21-6943-444a-bd6e-7327b9aa4618_e7397fbd-258b-4ea6-a4f2-48d5ff1d5e4d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Diamminediisocyanatozinc,122012-52-6," 1) Acute oral toxicity study, Sprague-Dawley rat (5/sex/group), LD50 values: Males + Females: 1127 (989-1285) mg/kg body weight / Males: 1208 (971-1503) mg/kg body weight / Females: 1052 (1038-1067) mg/kg body weight. 2) Acute oral toxicity study, Sprague-Dawley rat (5/sex/group), LD50 > 500 mg/kg 3) Acute dermal toxicity study, Sprague-Dawley rat (5/sex/group), LD50 > 2100 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc69e911-10c7-4f98-87e5-ea14f805557d/documents/07859cb7-e6d6-4102-b2ab-3021743a2766_e7397fbd-258b-4ea6-a4f2-48d5ff1d5e4d.html,,,,,, Diamminediisocyanatozinc,122012-52-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc69e911-10c7-4f98-87e5-ea14f805557d/documents/07859cb7-e6d6-4102-b2ab-3021743a2766_e7397fbd-258b-4ea6-a4f2-48d5ff1d5e4d.html,,oral,LD50,"1,052 mg/kg bw",adverse effect observed, Diamminediisocyanatozinc,122012-52-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc69e911-10c7-4f98-87e5-ea14f805557d/documents/07859cb7-e6d6-4102-b2ab-3021743a2766_e7397fbd-258b-4ea6-a4f2-48d5ff1d5e4d.html,,dermal,LD50,"2,100 mg/kg bw",no adverse effect observed, Diammineplatinum(II) nitrite,14286-02-3," In a guideline study, to GLP, the acute oral LD50 of diammineplatinum dinitrite was determined to be around 5000 mg/kg bw in rats (Berthold, 1989). No relevant acute dermal or inhalation toxicity data were identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6866f55-76ea-4dc5-9cb9-4bbb2a045256/documents/IUC5-c8a5509b-cb35-4e49-884f-58ce2821aca4_08ce9f9b-e378-4d05-b745-212b15a5bdb7.html,,,,,, Diammineplatinum(II) nitrite,14286-02-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6866f55-76ea-4dc5-9cb9-4bbb2a045256/documents/IUC5-c8a5509b-cb35-4e49-884f-58ce2821aca4_08ce9f9b-e378-4d05-b745-212b15a5bdb7.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Diammonium [[N,N'-ethylenebis[N-(carboxylatomethyl)glycinato]](4-)-N,N',O,O',ON,ON']zincate(2-)",67859-51-2,"With regard to the evaluation of repeated dose toxicity for EDTA-Zn(NH4)2, results of the study with EDTA-CaNa2 were compared with studies with other metal chelates and with EDTA (see below). One repeated inhalation toxicity study was avalaible for DTPA-CaNa3, another, Ca-containing chelate.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09dbab4e-b300-4aa2-a119-952415f9ecae/documents/IUC5-55f13242-a4a8-458d-832e-3fb327387096_836c7374-517d-4a36-a4ec-92e1848ec0c5.html,,,,,, "Diammonium [[N,N'-ethylenebis[N-(carboxylatomethyl)glycinato]](4-)-N,N',O,O',ON,ON']zincate(2-)",67859-51-2,"The acute oral LD50 value in rats was > 2000 mg/kg bw. Although an acute inhalation with this substance was not performed, inhalation studies with other metal chelates showed that these substances are not toxic (4-h LC50 value > 5 mg/L). In addition, acute dermal toxicity studies with other metal chelates showed that LD50 values were in excess of 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09dbab4e-b300-4aa2-a119-952415f9ecae/documents/IUC5-82cd77cd-867f-479d-935e-0546aeadaa08_836c7374-517d-4a36-a4ec-92e1848ec0c5.html,,,,,, "Diammonium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cobaltate(2-)",94233-08-6, LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae67c24e-e39f-4ce0-95fd-eb00b8d63ccc/documents/f7617c01-6b61-4b9d-94dc-c7c9b867d8e1_5a9bb7de-605a-4bd8-a2aa-ed10d4250b09.html,,,,,, "Diammonium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)",67989-88-2,One well performed and reported subchronic oral toxicity study was available for EDTA-CuNa2.   ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c176ce73-f43f-468c-b80d-825705c1b2b6/documents/IUC5-262e1ebb-cd54-4958-b4c7-65edc64501b2_694c4f81-ffd1-4fae-9125-d44410e0a347.html,,,,,, "Diammonium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)",67989-88-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c176ce73-f43f-468c-b80d-825705c1b2b6/documents/IUC5-262e1ebb-cd54-4958-b4c7-65edc64501b2_694c4f81-ffd1-4fae-9125-d44410e0a347.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,150 mg/kg bw/day,,rat "Diammonium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)",67989-88-2,"The oral LD50 value in rats was between 300 and 2000 mg/kg bw; the 4-h LC50 value of EDTA-CuNa2 is in excess of 5.30 g/m3. No acute dermal toxicity studies are available but based on read across (see also section 13), acute dermal toxicity following exposure to EDTA-Cu(NH4)2 is not expected.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c176ce73-f43f-468c-b80d-825705c1b2b6/documents/IUC5-9f7ed1d5-fa66-462e-a610-3c6eb5f77b90_694c4f81-ffd1-4fae-9125-d44410e0a347.html,,,,,, "Diammonium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']hydroxyferrate(2-)",68413-60-5,"Based on read across, the data of very structurally related substances were used. In rats, the NOAEL of EDTA-FeNa was >= 84 mg/kg bw/day (61 days) and for DTPA-FeNaH (at least 13 weeks) 500 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc5b3b69-08a3-441e-9f65-27a255c3a76b/documents/IUC5-7938f71c-040a-4abe-a5f0-088e8cea90b7_a75405a4-18d5-4145-9b1a-0da3eadab47c.html,,,,,, "Diammonium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']hydroxyferrate(2-)",68413-60-5,"An acute oral and an acute dermal study were available. In addition, an acute inhalation toxicity study was available of a very structurally-related substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc5b3b69-08a3-441e-9f65-27a255c3a76b/documents/IUC5-2e5d0254-fa39-4cf1-97e4-5fca7e09fb0b_a75405a4-18d5-4145-9b1a-0da3eadab47c.html,,,,,, "Diammonium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']manganate(2-)",94233-07-5,"An oral study with EDTA-MnNa2 in which males were treated for at least 12 weeks and females for almost 14 weeks showed effects on water intake, urinary sodium concentration, increased kidney weight and slight histopathological renal changes. Four repeated oral toxicity studies were available for EDTA-CaNa2; results of these studies were compared with studies with other metal chelates and with EDTA (see below). One repeated inhalation toxicity study was avalaible for DTPA-CaNa3. Several ip and iv studies were also available showing various effects but mostly on kidneys. However, as workers and consumers are not exposed via these non-physiological routes these studies are not further taken into account. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee54205e-ea95-4569-8438-16f46929e0c7/documents/IUC5-f31e3352-bcc2-4533-9a8b-074ff8158d8d_a107445a-6c6a-415e-84e1-5dbdeb46d900.html,,,,,, "Diammonium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']manganate(2-)",94233-07-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee54205e-ea95-4569-8438-16f46929e0c7/documents/IUC5-f31e3352-bcc2-4533-9a8b-074ff8158d8d_a107445a-6c6a-415e-84e1-5dbdeb46d900.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Diammonium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']manganate(2-)",94233-07-5,The acute oral toxicity test did not show mortality at a limit dose of 2000 mg/kg bw and the 4-h inhalation toxicity study with the read across substance EDTA-MnNa2 did not show mortality at the limit concentration of 5000 mg/m3. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee54205e-ea95-4569-8438-16f46929e0c7/documents/IUC5-7ab83678-486b-48a3-a93b-ba57dafb4837_a107445a-6c6a-415e-84e1-5dbdeb46d900.html,,,,,, Diammonium bis[carbonato-O]dihydroxyzirconate,68309-95-5,A GLP-compliant oral gavage combined repeat dose toxicity study with reproduction / developmental toxicity screening test in the rat has been conducted in accordance with OECD Guideline 422 (1996). No treatment-related effects were observed at dose levels up to and including 1000 mg/kg/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a056bc8e-fffa-445f-9980-4a7a53731f1c/documents/IUC5-4ce72beb-5cd5-42d1-aad0-80843b32e687_850a653f-34e1-446c-affd-eaf60ac3698f.html,,,,,, Diammonium bis[carbonato-O]dihydroxyzirconate,68309-95-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a056bc8e-fffa-445f-9980-4a7a53731f1c/documents/IUC5-4ce72beb-5cd5-42d1-aad0-80843b32e687_850a653f-34e1-446c-affd-eaf60ac3698f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Diammonium bis[carbonato-O]dihydroxyzirconate,68309-95-5,A GLP-compliant study acute oral toxicity study in the rat has been conducted to a method similar to OECD Guideline 401.The acute oral LD50 of the substance has been determined to be approximately 2900 mg/kg.A GLP compliant study acute dermal toxicity study in the rat has been conducted in accordance with OECD Guideline 402. The acute dermal LD50 of the substance has been determined to be greater than 2000 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a056bc8e-fffa-445f-9980-4a7a53731f1c/documents/IUC5-6fd6284b-5795-4f16-80c4-919fdc2351eb_850a653f-34e1-446c-affd-eaf60ac3698f.html,,,,,, Diammonium bis[carbonato-O]dihydroxyzirconate,68309-95-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a056bc8e-fffa-445f-9980-4a7a53731f1c/documents/IUC5-6fd6284b-5795-4f16-80c4-919fdc2351eb_850a653f-34e1-446c-affd-eaf60ac3698f.html,,oral,LD50,"2,900 mg/kg bw",, Diammonium decaborate,12007-89-5," A number of sub-chronic and chronic studies on boric acid and disodium tetraborate decahydrate were carried out in rats, mice and dogs. In some cases these studies are research studies (Weir and Fisher, 1972; Dixon et al, 1976; Seal and Weeth, 1980; Lee et al., 1978; Treinen and Chapin, 1991; Ku et al., 1993), but most support that boron can cause adverse haematological effects and that the main target organ of boron toxicity is the testis. The NOAEL is equivalent to 17.5 mg B/kg bw/day that corresponds to NOAEL of 64.77 mg diammonium decaborate /kg bw (Weir, 1966). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea859a8d-fb3e-4f10-8ff5-77bdd73e1e3e/documents/IUC5-c6728004-7015-4e52-b335-ce43e716a3b9_65213be8-7b34-453f-a55b-5fc3f8b1c0cc.html,,,,,, Diammonium decaborate,12007-89-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea859a8d-fb3e-4f10-8ff5-77bdd73e1e3e/documents/IUC5-c6728004-7015-4e52-b335-ce43e716a3b9_65213be8-7b34-453f-a55b-5fc3f8b1c0cc.html,Short-term repeated dose toxicity – systemic effects,inhalation,BMCL05,67.2 mg/m3,,rat Diammonium decaborate,12007-89-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea859a8d-fb3e-4f10-8ff5-77bdd73e1e3e/documents/IUC5-c6728004-7015-4e52-b335-ce43e716a3b9_65213be8-7b34-453f-a55b-5fc3f8b1c0cc.html,Chronic toxicity – systemic effects,oral,NOAEL,64.77 mg/kg bw/day,,rat Diammonium decaborate,12007-89-5," Acute oral, dermal and inhalation studies have been performed with the read-across substance boric acid.  Experimental data showed low acute toxicity to boric acid. The mean of the male and female values were obtained from the key study (oral route; Keller 1962). The LD50 is equivalent to 658.9 mg B/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea859a8d-fb3e-4f10-8ff5-77bdd73e1e3e/documents/IUC5-2a914e53-a67f-467a-89c5-328a53d08a34_65213be8-7b34-453f-a55b-5fc3f8b1c0cc.html,,,,,, Diammonium decaborate,12007-89-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea859a8d-fb3e-4f10-8ff5-77bdd73e1e3e/documents/IUC5-2a914e53-a67f-467a-89c5-328a53d08a34_65213be8-7b34-453f-a55b-5fc3f8b1c0cc.html,,oral,LD50,"3,765 mg/kg bw",no adverse effect observed, Diammonium decaborate,12007-89-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea859a8d-fb3e-4f10-8ff5-77bdd73e1e3e/documents/IUC5-2a914e53-a67f-467a-89c5-328a53d08a34_65213be8-7b34-453f-a55b-5fc3f8b1c0cc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Diammonium decaborate,12007-89-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea859a8d-fb3e-4f10-8ff5-77bdd73e1e3e/documents/IUC5-2a914e53-a67f-467a-89c5-328a53d08a34_65213be8-7b34-453f-a55b-5fc3f8b1c0cc.html,,inhalation,LC50,"2,000 mg/m3",no adverse effect observed, Diammonium dihydrogenpyrophosphate,13597-86-9,"The pivotal repeated dose study was a 52 week study by the oral route with the analogous substance ammonium sulphate. In male and female rats, dietary administration of ammonium sulphate resulted in an increase in absolute and relative kidney weights at the high dose level for both sexes. Absolute spleen weights were decreased and relative liver weights were increased in high dose males only. The NOAEL for these effects was 0.6% in the diet, which is equivalent to 256 and 284 mg/kg bw/d in males and females, respectively. The study was performed to methods equivalent to OECD 453, with few deviations. The deviations noted probably arise as a result of the publication of this data in a journal format as opposed to a study report. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a17d7d68-4df3-4aed-961d-4d0f91ec9946/documents/IUC5-b85605f9-2e49-401e-a873-2192b8de16ff_e4e85e6b-5e2a-4965-8f40-e21d9650f067.html,,,,,, Diammonium dihydrogenpyrophosphate,13597-86-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a17d7d68-4df3-4aed-961d-4d0f91ec9946/documents/IUC5-b85605f9-2e49-401e-a873-2192b8de16ff_e4e85e6b-5e2a-4965-8f40-e21d9650f067.html,Chronic toxicity – systemic effects,oral,NOAEL,256 mg/kg bw/day,,rat Diammonium dihydrogenpyrophosphate,13597-86-9,The data available is performed on analogous substances. This data is considered adequate and reliable to fulfil the information requirements as part of a weight of evidence. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a17d7d68-4df3-4aed-961d-4d0f91ec9946/documents/IUC5-ffa63a15-182a-41d5-9fe2-16579c5b3523_e4e85e6b-5e2a-4965-8f40-e21d9650f067.html,,,,,, Diammonium dihydrogenpyrophosphate,13597-86-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a17d7d68-4df3-4aed-961d-4d0f91ec9946/documents/IUC5-ffa63a15-182a-41d5-9fe2-16579c5b3523_e4e85e6b-5e2a-4965-8f40-e21d9650f067.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Diammonium dihydrogenpyrophosphate,13597-86-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a17d7d68-4df3-4aed-961d-4d0f91ec9946/documents/IUC5-ffa63a15-182a-41d5-9fe2-16579c5b3523_e4e85e6b-5e2a-4965-8f40-e21d9650f067.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Diammonium dihydroxybis[lactato(2-)-O1,O2]titanate(2-)",65104-06-5,"As there were no treatment-related effects on systemic, reproduction and fertility parameters up to and including the highest dose tested 1000 mg/kg/day, the No Observed Adverse Effect Level (NOAEL) for Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test by Oral Gavage in Wistar rats for the test item, Tyzor LA is determined to be 1000 mg/kg/day under the test conditions and doses employed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a7403a2-76b7-4c01-9f33-c2983f287423/documents/bee33dfe-da4f-4e78-9d2e-69005d27e69c_bda7527a-e265-4bf7-a2ba-7c6e2cf6b52d.html,,,,,, "Diammonium dihydroxybis[lactato(2-)-O1,O2]titanate(2-)",65104-06-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a7403a2-76b7-4c01-9f33-c2983f287423/documents/bee33dfe-da4f-4e78-9d2e-69005d27e69c_bda7527a-e265-4bf7-a2ba-7c6e2cf6b52d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Diammonium dihydroxybis[lactato(2-)-O1,O2]titanate(2-)",65104-06-5,"Acute toxicity: oral: LD50 17 000 mg/kg bw Acute toxicity: inhalation: the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Acute toxicity: dermal: the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation).  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a7403a2-76b7-4c01-9f33-c2983f287423/documents/b8936af1-e7b0-4cba-a690-8de723a30f73_bda7527a-e265-4bf7-a2ba-7c6e2cf6b52d.html,,,,,, "Diammonium dihydroxybis[lactato(2-)-O1,O2]titanate(2-)",65104-06-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a7403a2-76b7-4c01-9f33-c2983f287423/documents/b8936af1-e7b0-4cba-a690-8de723a30f73_bda7527a-e265-4bf7-a2ba-7c6e2cf6b52d.html,,oral,discriminating dose,"17,000 mg/kg bw",no adverse effect observed, Diammonium dimolybdate,27546-07-2,"NOAEL for systemic toxicity, oral, from a sub-chronic study with sodium molybdate dihydrate in rats (Hoffman, 2011): 17 mg Mo/kg bw/day. Unbounded NOAEC for systemic toxicity, inhalation, from a sub-chronic study with molybdenum trioxide in rats and mice (NTP, 1997): 66.7 mg Mo/m³. Important: both values expressed based on element Mo (for read-across purposes), not on the respective test substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/651aa097-ba28-4d3b-8d7f-f95a418e5700/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_03a0cd27-6737-4712-bfcf-dd3821ab1511.html,,,,,, Diammonium dimolybdate,27546-07-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/651aa097-ba28-4d3b-8d7f-f95a418e5700/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_03a0cd27-6737-4712-bfcf-dd3821ab1511.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat Diammonium dimolybdate,27546-07-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/651aa097-ba28-4d3b-8d7f-f95a418e5700/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_03a0cd27-6737-4712-bfcf-dd3821ab1511.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,66.7 mg/m3,,other:rats and mice Diammonium dimolybdate,27546-07-2," To avoid unnecessary (animal) testing, a comprehensive grouping and read-across concept has been developed amongst several molybdenum containing substances. Acute oral, inhalation and dermal toxicity studies are available for several but not all substances in the category. The following LD50s are therefore either based on test data for the substance in this dossier, or based on read-across within the category: For ammonium dimolybdate: LD50oral = 3883 mg/kg bw (based on study with this substance) LD50dermal > 2000 mg/kg bw (limit test) (based on study with this substance) LC50inhalation, 4h > 2.08 g/m³ (maximum attainable concentration) (based on study with this substance) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/651aa097-ba28-4d3b-8d7f-f95a418e5700/documents/IUC5-202a9e05-95ed-4cd1-90c9-e7650ab51919_03a0cd27-6737-4712-bfcf-dd3821ab1511.html,,,,,, Diammonium hexachloroiridate,16940-92-4, The acute median lethal oral dose (LD50) to rats of Diammonium Hexachloroiridate was demonstrated to be between 300 and 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d2255e0-8f3b-4c51-b711-1c52d8b2c056/documents/IUC5-c8c1823e-4f29-4ca5-954d-b6d60d8dffd5_15b38f1b-4372-40ca-800b-7613f5c61bdc.html,,,,,, Diammonium hexachloroiridate,16940-92-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d2255e0-8f3b-4c51-b711-1c52d8b2c056/documents/IUC5-c8c1823e-4f29-4ca5-954d-b6d60d8dffd5_15b38f1b-4372-40ca-800b-7613f5c61bdc.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Diammonium hexachloropalladate,19168-23-1," In an OECD Test Guideline 407 study, to GLP, rats were administered diammonium hexachloropalladate by gavage for 28 days. The systemic NOAEL was the highest tested dose (100 mg/kg bw/day). Although there were some treatment-related effects at this dose (histological inflammation of the glandular stomach mucosa of both sexes and elevated mean white blood cell counts in males), these were considered to reflect a local irritant effect of the test substance rather than systemic toxicity (Matting, 2015). The critical oral NOAEL for diammonium hexachloropalladate (100 mg/kg bw/day) equates to an NOAEL of 30 mg/kg bw/day for palladium (based on MWt ratio). In an GLP OECD Test Guideline 421 reproductive/developmental toxicity screening study (Török-Bathó, 2015), high dose (100 mg/kg bw/day) parental animals displayed only local effects in the glandular stomach mucosa, similar to those seen in the 28-day toxicity study. No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a23e9d5-7e08-401c-9192-4af581ba7ea2/documents/IUC5-5d846527-3a1a-4104-a18a-80a00a1338f9_30c97544-594a-42c9-9d93-4a0feb1363bc.html,,,,,, Diammonium hexachloropalladate,19168-23-1,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a23e9d5-7e08-401c-9192-4af581ba7ea2/documents/IUC5-5d846527-3a1a-4104-a18a-80a00a1338f9_30c97544-594a-42c9-9d93-4a0feb1363bc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Diammonium hexachloropalladate,19168-23-1," In a GLP study, similar to OECD guidelines, an acute oral LD50 of 1226 mg/kw bw was reported in rats gavaged with diammonium hexachloropalladate, and observed for up to 14 days (Dreher, 1989). No acute inhalation or dermal toxicity data were identified. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a23e9d5-7e08-401c-9192-4af581ba7ea2/documents/IUC5-13864463-c9ba-4b90-b119-797f23ab1982_30c97544-594a-42c9-9d93-4a0feb1363bc.html,,,,,, Diammonium hexachloropalladate,19168-23-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a23e9d5-7e08-401c-9192-4af581ba7ea2/documents/IUC5-13864463-c9ba-4b90-b119-797f23ab1982_30c97544-594a-42c9-9d93-4a0feb1363bc.html,,oral,LD50,"1,226 mg/kg bw",adverse effect observed, Diammonium hexachloroplatinate,16919-58-7," In an OECD Test Guideline 407 study, to GLP, rats (5/sex/group) were administered diammonium hexachloroplatinate by gavage for 28 days. The systemic toxicity NOAEL was 10 mg/kg bw/day on the basis of clinical signs of toxicity (including reduced body weight and growth) in the mid and high dose groups (30 and 100 mg/kg bw/day), resulting in morphological changes to the kidneys and stomach (Hansen, 2015a).   In support, in an OECD Test Guideline 421 reproductive/developmental toxicity screening study, rats (12/sex/group) were administered diammonium hexachloroplatinate by oral gavage at doses of 0, 10, 30 or 100 mg/kg bw/day for at least 35 days. The study NOAEL was established to be 30 mg/kg bw/day for systemic toxicity (Hansen, 2015b).   No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/2affa2e2-344f-47ed-9a9f-4be33fe66592/documents/ac2f828a-2352-451f-b002-5e64c72338c8_f6b8ce6a-dacf-450f-9153-a8635eb1382f.html,,,,,, Diammonium hexachloroplatinate,16919-58-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/2affa2e2-344f-47ed-9a9f-4be33fe66592/documents/ac2f828a-2352-451f-b002-5e64c72338c8_f6b8ce6a-dacf-450f-9153-a8635eb1382f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Diammonium hexachloroplatinate,16919-58-7," The acute oral LD50 of ammonium hexachloroplatinate is approximately 200 mg/kg bw in rats. Four of five females, but none of five males, died after a single oral dose at this level, suggesting that the LD50 in females maybe somewhat lower than this (Middleton, 1978a).   No relevant acute dermal or inhalation toxicity data were identified. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2affa2e2-344f-47ed-9a9f-4be33fe66592/documents/IUC5-d7f549af-9878-4514-a3db-29765bee8c70_f6b8ce6a-dacf-450f-9153-a8635eb1382f.html,,,,,, Diammonium hexachloroplatinate,16919-58-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2affa2e2-344f-47ed-9a9f-4be33fe66592/documents/IUC5-d7f549af-9878-4514-a3db-29765bee8c70_f6b8ce6a-dacf-450f-9153-a8635eb1382f.html,,oral,LD50,200 mg/kg bw,adverse effect observed, Diammonium hexanitratocerate,16774-21-3," Repeated dose toxicity - oral: No reliable repeated dose toxicity with the test substance is available. Braun (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test in rats according to OECD guideline 422 (GLP) with the read-across substance cerium trinitrate. Based on the results of this study, a NOAEL value for systemic toxicity of 330 mg/kg bw/day was derived. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity via the dermal route of exposure. Furthermore, as the substance is classified as corrosive to the skin, serious local effects may be expected after repeated dermal exposure to the diluted test item and, for reasons of animal welfare, the test should be avoided. Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity via the inhalation route of exposure. Furthermore, due to formation of clumps, the inhalation route is unlikely a possible route of exposure as the formation of respirable suspended particulate matter is unlikely. In addition, the substance is classified as corrosive to the skin and serious local effects might be expected after repeated inhalation exposure to the diluted test item. therefore, for reasons of animal welfare, the test should be avoided. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2741018-4de1-4830-a5e0-bbba11089dd5/documents/IUC5-bbef9b9d-0253-4d68-adbe-e4a3d1f6f0f1_e8343b73-0966-430d-8024-f9cb7908829c.html,,,,,, Diammonium hexanitratocerate,16774-21-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2741018-4de1-4830-a5e0-bbba11089dd5/documents/IUC5-bbef9b9d-0253-4d68-adbe-e4a3d1f6f0f1_e8343b73-0966-430d-8024-f9cb7908829c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,330 mg/kg bw/day,,rat Diammonium hexanitratocerate,16774-21-3,"Acute toxicity: oral: A K1 acute oral toxicity test - fixed dose method was performed in female Wistar rats according to a guideline similar to OECD Guideline 420 and EU Method B.1 bis (Bradshaw, 2013). Following a sighting test at dose levels of 2000 mg/kg and 300 mg/kg, a further group of four fasted females was given a single oral dose of test item, as a solution in distilled water, at a dose level of 300 mg/kg bodyweight. It was concluded that the oral LD50 was between 300-2000 mg/kg bw.Acute toxicity: inhalation: A key study is available for the oral and dermal route of exposure. According to the REACH Regulation, only one additional route of exposure should be tested other than the oral route of exposure for acute toxicity (column 2, annex VIII, section 8.5). Therefore, it is not necessary to perform an acute toxicity study via the inhalation route of exposure. Acute toxicity: dermal: An acute dermal study does not need to be conducted as the substance is classified as corrosive to the skin. In addition, a reliable study with the source substance cerium trinitrate is available. Based on this study, the LD50 of cerium ammonium nitrate is considered at least 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2741018-4de1-4830-a5e0-bbba11089dd5/documents/IUC5-ce7af76a-0ca3-450d-b2e0-5b8b4d8fead5_e8343b73-0966-430d-8024-f9cb7908829c.html,,,,,, Diammonium hexanitratocerate,16774-21-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2741018-4de1-4830-a5e0-bbba11089dd5/documents/IUC5-ce7af76a-0ca3-450d-b2e0-5b8b4d8fead5_e8343b73-0966-430d-8024-f9cb7908829c.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Diammonium oxalate,1113-38-8,"Sub-chronic oral repeated dose toxicity study in the rat (OECD 408): No treatment related effects were observed (e.g. functional observation battery, hematology, clinical biochemistry, adrenals, and thymus). The No Observed Adverse Effect Level (NOAEL) for the source substance oxalic acid was 1000 ppm. This value corresponds to 63 mg/kg bw/d. (RA from CAS 6153-56-6 (dihydrate), reference 7.5.1-1) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/716d9890-6927-42f5-9169-fa3a42862b3a/documents/dfaed8c5-9068-4849-aeed-ed548abe9a73_3789d296-12b3-4c1a-8c36-ef6fddab093b.html,,,,,, Diammonium oxalate,1113-38-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/716d9890-6927-42f5-9169-fa3a42862b3a/documents/dfaed8c5-9068-4849-aeed-ed548abe9a73_3789d296-12b3-4c1a-8c36-ef6fddab093b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,63 mg/kg bw/day,,rat Diammonium oxalate,1113-38-8,"Oral (no guideline followed), rat: LD50 = 375 mg/kg bw (female) (RA from CAS 144-62-7, reference 7.2.1-1)   Dermal (OECD 402), rat: LD50 = > 2000 mg/kg bw (female) (reference 7.2.3-1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/716d9890-6927-42f5-9169-fa3a42862b3a/documents/f4c4e495-4600-4793-bb64-1295751be49c_3789d296-12b3-4c1a-8c36-ef6fddab093b.html,,,,,, Diammonium oxalate,1113-38-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/716d9890-6927-42f5-9169-fa3a42862b3a/documents/f4c4e495-4600-4793-bb64-1295751be49c_3789d296-12b3-4c1a-8c36-ef6fddab093b.html,,oral,LD50,375 mg/kg bw,adverse effect observed, Diammonium oxalate,1113-38-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/716d9890-6927-42f5-9169-fa3a42862b3a/documents/f4c4e495-4600-4793-bb64-1295751be49c_3789d296-12b3-4c1a-8c36-ef6fddab093b.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Diammonium phosphonate,22132-71-4, NOEL oral rat subacute > 1000 mg/Kg bw ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/945da36e-9a58-47cf-9899-15bb62caaf04/documents/15439712-520c-4aa8-a9b6-645ac0e2e0d6_32b58ddb-1971-408f-a45b-a7db4dbc8bfc.html,,,,,, Diammonium phosphonate,22132-71-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/945da36e-9a58-47cf-9899-15bb62caaf04/documents/15439712-520c-4aa8-a9b6-645ac0e2e0d6_32b58ddb-1971-408f-a45b-a7db4dbc8bfc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Diammonium phosphonate,22132-71-4, LD50 Acute Oral rat > 2000 mg/Kg bw LD50 Acute Dermal rat > 5000 mg/Kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/945da36e-9a58-47cf-9899-15bb62caaf04/documents/d027e785-9700-49eb-b322-cc9d7c8bbc39_32b58ddb-1971-408f-a45b-a7db4dbc8bfc.html,,,,,, Diammonium phosphonate,22132-71-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/945da36e-9a58-47cf-9899-15bb62caaf04/documents/d027e785-9700-49eb-b322-cc9d7c8bbc39_32b58ddb-1971-408f-a45b-a7db4dbc8bfc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Diammonium phosphonate,22132-71-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/945da36e-9a58-47cf-9899-15bb62caaf04/documents/d027e785-9700-49eb-b322-cc9d7c8bbc39_32b58ddb-1971-408f-a45b-a7db4dbc8bfc.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Diammonium sodium hexakis(nitrito-N)rhodate,64164-17-6," In an OECD Test Guideline 422 combined repeated dose and reproductive/developmental toxicity screening study in rats, involving the gavage administration of diammonium sodium hexakis(nitrito-N)rhodate for at least 28 days, no treatment-related adverse effects were observed at up to the highest tested dose (1000 mg/kg bw/day) (Török-Bathó, 2015).   No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c3bc0c1-217c-4326-b25c-cba0e9d638ef/documents/010c24dd-8adf-49f4-ac3a-85eb1f4f117c_7d766df9-b6c4-40c9-b625-bff7330802ab.html,,,,,, Diammonium sodium hexakis(nitrito-N)rhodate,64164-17-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c3bc0c1-217c-4326-b25c-cba0e9d638ef/documents/010c24dd-8adf-49f4-ac3a-85eb1f4f117c_7d766df9-b6c4-40c9-b625-bff7330802ab.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Diammonium sodium hexakis(nitrito-N)rhodate,64164-17-6," In an OECD guideline study, the acute oral LD50 value for diammonium sodium hexakis(nitrito-N)rhodate was determined to exceed 2000 mg/kg bw following gavage administration in female rats.   No relevant acute dermal or inhalation toxicity data were identified. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c3bc0c1-217c-4326-b25c-cba0e9d638ef/documents/720fabe2-c06c-428a-bfce-01f442f0ca0f_7d766df9-b6c4-40c9-b625-bff7330802ab.html,,,,,, Diammonium tartrate,3164-29-2, Oral (no guideline followed): NOAEL ≥ 3100 mg/kg bw/day (males); NOAEL ≥ 4100 mg/kg bw/day (females); RA from source substance Monosodium L(+) tartrate (CAS 526 -94 -3) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/42813e98-4af3-4206-aa74-54654f707772/documents/4ec92312-874f-428a-8ba6-77f4ca45ef8f_475faad5-1b44-49f0-8b43-8768fd8e498a.html,,,,,, Diammonium tartrate,3164-29-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/42813e98-4af3-4206-aa74-54654f707772/documents/4ec92312-874f-428a-8ba6-77f4ca45ef8f_475faad5-1b44-49f0-8b43-8768fd8e498a.html,Chronic toxicity – systemic effects,oral,NOAEL,"3,100 mg/kg bw/day",,rat Diammonium tartrate,3164-29-2," Oral (no guideline followed), rat: LD50 > 3100 mg/kg bw RA from source substance Monosodium L(+) tartrate (CAS 526 -94 -3) Inhalation: no data available Dermal: no data available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42813e98-4af3-4206-aa74-54654f707772/documents/4347d71b-7d68-4062-98c3-0075ed4c2284_475faad5-1b44-49f0-8b43-8768fd8e498a.html,,,,,, Diammonium tartrate,3164-29-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42813e98-4af3-4206-aa74-54654f707772/documents/4347d71b-7d68-4062-98c3-0075ed4c2284_475faad5-1b44-49f0-8b43-8768fd8e498a.html,,oral,LD50,"3,100 mg/kg bw",no adverse effect observed, Diammonium tetrachlorozincate(2-),14639-97-5,"Animal data Oral: The repeated dose toxicity of the zinc category substances has been examined in a number of sub-chronic oral repeated dose toxictiy studies. The NOAEL for systemic effects of the zinc category substances was determined to be 25 mg Zn/kg bw/day, derived in an oral 90-day study with nano zinc oxide in rats. Inhalation: The repeated dose inhalation toxicity of micro and nano-ZnO has been examined respectively in a subacute (28 days) and two subchronic (90 days) inhalation studies. The lowest NOAEC was determined to be 0.47 mg/m³ (target concentration: 0.5 mg/m³) for micro ZnO. For nano-ZnO the BMCL10 was determined to be 0.971 mg/m³. Dermal: No adverse effects were observed in a 90-day repeated dose toxicity study via the dermal route with nano-ZnO. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): guideline studies available ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51012cd4-5f90-4d28-9f80-4316bfbd2528/documents/d3dbfe8d-29df-4047-bae7-35d291fdb315_e12ba6ca-dc82-4656-a132-903ef82f877f.html,,,,,, Diammonium tetrachlorozincate(2-),14639-97-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51012cd4-5f90-4d28-9f80-4316bfbd2528/documents/d3dbfe8d-29df-4047-bae7-35d291fdb315_e12ba6ca-dc82-4656-a132-903ef82f877f.html,Repeated dose toxicity – local effects,inhalation,BMCL10,0.971 mg/m3,adverse effect observed,rat Diammonium tetrachlorozincate(2-),14639-97-5,"No specific acute toxicity data were identified for diammonium tetrachlorozincate but it is (due to its similar solubility characteristics) likely to display a toxicity profile similar to that of zinc chloride, zinc sulphate, zinc bis(dihydrogen phosphate) or zinc nitrate.   oral: Assessment of the acute oral toxicity of zinc chloride was studied in Sprague-Dawley rats and Swiss mouse according to OECD guideline no 401 .The LD50 value was within the range of 1,100 to 1,260 mg/kg bw. In the 10 min inhalation study in female Sprague-Dawley rats, zinc chloride has demonstrated acute toxicity via the inhalation route (LC50 ≤ 1,975 mg/m3). However, since the exposure of the animals to the size of the particles is not truly representative of exposure to humans under normal conditions, it is difficult to assess whether or not, zinc chloride is acutely toxic since a four hour LC50 value could not be derived and a clear dose-response relationhip coud not be established. Airway irritation has been observed both in animals and in humans, zinc chloride has the potential to be a respiratory tract irritant.   Assessment of the acute oral toxicity of zinc sulphate was studied in Sprague-Dawley or Wistar rats and Swiss mouse according to OECD guideline no 401 or 423. Soluble zinc sulphate (monohydrate, hexahydrate and heptahydrate) has LD50 oral values ranging from 574 to 2,949 mg/kg bw, 862 to 4,429 mg/kg bw and 920 to 4,725 mg/kg bw, respectively for the three forms of zinc sulphate. Effects of inhalation exposure to zinc sulphate were limited to pulmonary effects only. Assessment of acute dermal toxicity was studied on the skin of Wistar rats  at 2000 mg/kg bw  for 24 hours (OECD guideline no 402) demonstrating zinc sulphate is not acutely toxic via the dermal route (LD50 >2,000 mg/kg bw)   Assessment of the acute oral toxicity of zinc bis(dihydrogen phosphate) was studied in Wistar CRL/WI rats according to OECD guideline no 423 (Acute toxic Class Method). The LD50 value was established to be within the range of >300 to <2000 mg/kg bw. According to OECD 423 test guideline and based on the LD50 cut-off values, the LD50 value was considered to be 1000mg/kg bw.   Assessment of the acute oral toxicity of zinc nitrate was studied in Wistar CRL/WI rats according to OECD guideline no 423 (Acute toxic Class Method) .The LD50 value was established to be greater than 300 mg/kg bw but less than 2000 mg/kg bw.   inhalation: In the 10 min inhalation study in female Sprague-Dawley rats, zinc chloride has demonstrated acute toxicity via the inhalation route (LC50 ≤ 1,975 mg/m3). However, since the exposure of the animals to the size of the particles is not truly representative of exposure to humans under normal conditions, it is difficult to assess whether or not, zinc chloride is acutely toxic since a four hour LC50 value could not be derived and a clear dose-response relationhip coud not be established. Airway irritation has been observed both in animals and in humans, zinc chloride has the potential to be a respiratory tract irritant.   dermal: Assessment of acute dermal toxicity was studied on the skin of Wistar rats at 2000 mg/kg bw for 24 hours (OECD guideline no 402) demonstrating zinc sulphate is not acutely toxic via the dermal route (LD50 >2,000 mg/kg bw) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51012cd4-5f90-4d28-9f80-4316bfbd2528/documents/IUC5-616a8fdc-fbeb-4a72-8a98-24dacf7739b8_e12ba6ca-dc82-4656-a132-903ef82f877f.html,,,,,, Diammonium tetrachlorozincate(2-),14639-97-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51012cd4-5f90-4d28-9f80-4316bfbd2528/documents/IUC5-616a8fdc-fbeb-4a72-8a98-24dacf7739b8_e12ba6ca-dc82-4656-a132-903ef82f877f.html,,oral,LD50,"1,100 mg/kg bw",adverse effect observed, Diammonium tetrachlorozincate(2-),14639-97-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51012cd4-5f90-4d28-9f80-4316bfbd2528/documents/IUC5-616a8fdc-fbeb-4a72-8a98-24dacf7739b8_e12ba6ca-dc82-4656-a132-903ef82f877f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Diammonium tetrachlorozincate(2-),14639-97-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51012cd4-5f90-4d28-9f80-4316bfbd2528/documents/IUC5-616a8fdc-fbeb-4a72-8a98-24dacf7739b8_e12ba6ca-dc82-4656-a132-903ef82f877f.html,,inhalation,LC50,"1,975 mg/m3",adverse effect observed, Diantimony pentoxide,1314-60-9," Based on the fact that diantimony pentoxide, sodium hexahydroxoantimonate and sodium antimonate contain antimony in the pentavalent oxidation state and that water solubility testing as well as transformation dissolution testing has shown similar dissolution pattern of pentavalent antimony cations form all three substances, read-across among the pentavalent antimony compounds (i.e. sodium hexahydroxoantimonate, sodium antimonate and diantimony pentoxide) is considered justified.   No test item related changes were observed in a 90-day repeated dose toxicity study via oral route up to the limit dose of 1000 mg/kg bw/day with sodium hexahydroxoantimonate. The no-observed-effect level (NOEL) was above 1000 mg sodium hexahydroxoantimonate/kg b.w./day, p.o. for the male and female rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1891c7d-4d90-414d-8be1-9cd8739580c0/documents/6d833c9e-925b-4d67-b1c5-292bfe3b5666_3ce83c96-8507-4061-a45c-e7fbca469889.html,,,,,, Diantimony pentoxide,1314-60-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1891c7d-4d90-414d-8be1-9cd8739580c0/documents/6d833c9e-925b-4d67-b1c5-292bfe3b5666_3ce83c96-8507-4061-a45c-e7fbca469889.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Diantimony pentoxide,1314-60-9," Acute toxicity, oral: LD50 > 2000 mg/kg bw Acute toxicity, inhalation: LC50 > 5.40 mg sodium hexahydroxoantimonate/L air Based on the results of the histopathological and macroscopic investigations, sodium hexahydroxoantimonate (and by read-across antimony pentoxide and sodium antimonate) does not require classification for respiratory irritation. Acute toxicity, dermal: Conduct of an acute dermal toxicity study is unjustified as inhalation of the substance is considered as major route of exposure and physicochemical properties of the substance do not suggest a significant rate of absorption through the skin (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1891c7d-4d90-414d-8be1-9cd8739580c0/documents/e42c71a8-cf9c-4285-aa03-aef8e04e8987_3ce83c96-8507-4061-a45c-e7fbca469889.html,,,,,, "Dibenzo[b,f]cyclohepten-1-one",2222-33-5," LD50 was estimated to be 2125 mg/kg bw when rats were orally exposed with 1H-dibenzo[a,d][7]annulen-1-one. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cb091bf-5cae-4a4e-a956-47a42ee10f3d/documents/ef1cd9c4-cf2b-4af7-8404-5a237b2dac51_b762b8ba-9258-43fc-8bdf-d101f6e1708a.html,,,,,, "Dibenzo[b,f]cyclohepten-1-one",2222-33-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cb091bf-5cae-4a4e-a956-47a42ee10f3d/documents/ef1cd9c4-cf2b-4af7-8404-5a237b2dac51_b762b8ba-9258-43fc-8bdf-d101f6e1708a.html,,oral,LD50,"2,125 mg/kg bw",no adverse effect observed, Dibenzoyl-L-tartaric acid monohydrate,2743-38-6, Key study. Method similar to OECD 401 (non-GLP study). The oral LD50 of the test item in rats is > 5000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/024c7dfb-d343-4065-a7ba-c851f6a97415/documents/0ba03890-c2e8-44d4-bddd-36750d32c33f_5482d2f9-8f3c-4f06-ab4a-0dfb39fc756e.html,,,,,, Dibenzoyl-L-tartaric acid monohydrate,2743-38-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/024c7dfb-d343-4065-a7ba-c851f6a97415/documents/0ba03890-c2e8-44d4-bddd-36750d32c33f_5482d2f9-8f3c-4f06-ab4a-0dfb39fc756e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Dibenzylamine,103-49-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6dff0924-49a9-4bcf-8ffd-ad139b478ca1/documents/IUC5-de4bba04-8f95-436e-b52c-4a0bbfd4e5a0_c4ead588-e924-4044-a525-565b36a669ec.html,,oral,LD50,ca.632 mg/kg bw,adverse effect observed, "Dibenzylbenzene, ar-methyl derivative",53585-53-8,"A GLP OECD 408 repeated toxicity study (Sanofi, 1992) was performed on the registered substance. In this 4-month oral toxicity study, the NOAEL was found to be 50 mg/kg bw/day, based on a LOAEL estimated at 500 mg/kg bw/day (effects on liver in both sexes).When dibenzyltoluene (trade name: JARYLEC DBT) is administered at 50 mg/kg bw/day, slight hypertrophy of centrilobular hepatocytes was seen in few animals (2/20) without any other changes. Thus, this dose level was considered as the NOAEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11e9920b-e602-4dbd-93b9-fd28eef0f757/documents/IUC5-b1623b4b-d2fd-48ab-b24c-f87003cafb92_43d6af44-0e1c-4cf1-b7a1-8819c3d8ff81.html,,,,,, "Dibenzylbenzene, ar-methyl derivative",53585-53-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11e9920b-e602-4dbd-93b9-fd28eef0f757/documents/IUC5-b1623b4b-d2fd-48ab-b24c-f87003cafb92_43d6af44-0e1c-4cf1-b7a1-8819c3d8ff81.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Dibenzylbenzene, ar-methyl derivative",53585-53-8,"Available information indicate that the Dibenzylbenzene, ar-methyl derivative is practically not toxic after single oral (LD50 > 10360 mg/kg), dermal (LD0 > 2000 mg/kg) or inhalative (LC0 > 0.24 mg/m³) exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11e9920b-e602-4dbd-93b9-fd28eef0f757/documents/IUC5-c598f5bc-8ffb-4613-b8f9-c95041c3cb0a_43d6af44-0e1c-4cf1-b7a1-8819c3d8ff81.html,,,,,, "Dibenzylbenzene, ar-methyl derivative",53585-53-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11e9920b-e602-4dbd-93b9-fd28eef0f757/documents/IUC5-c598f5bc-8ffb-4613-b8f9-c95041c3cb0a_43d6af44-0e1c-4cf1-b7a1-8819c3d8ff81.html,,oral,LD0,"> 10,360 mg/kg bw",no adverse effect observed, "Dibenzylbenzene, ar-methyl derivative",53585-53-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11e9920b-e602-4dbd-93b9-fd28eef0f757/documents/IUC5-c598f5bc-8ffb-4613-b8f9-c95041c3cb0a_43d6af44-0e1c-4cf1-b7a1-8819c3d8ff81.html,,dermal,LD0,"> 2,000 mg/kg bw",no adverse effect observed, "Dibenzylbenzene, ar-methyl derivative",53585-53-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11e9920b-e602-4dbd-93b9-fd28eef0f757/documents/IUC5-c598f5bc-8ffb-4613-b8f9-c95041c3cb0a_43d6af44-0e1c-4cf1-b7a1-8819c3d8ff81.html,,inhalation,LC0,> 0.24 mg/m3,no adverse effect observed, Dibenzyldimethylammonium chloride,100-94-7, Oral: An LD50 of ca. 1815 mg/kg was determined after an oral administration of the test substance to rats via gavage. Inhalation: In an IHT test no mortalities were observed when rats were exposed for 8 hours to an atmosphere enriched with the test substance vapour generated at 20°C (13.75 mg/L) and 100°C (43.36 mg/L). Dermal: No information available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/696b7a2e-3d2c-40ce-8895-4cd687a8f3f1/documents/28cb1aa5-f14b-4e67-8a88-763f2980d480_f17f607d-9704-42bc-ad67-f01ae9da87f2.html,,,,,, Dibenzyldimethylammonium chloride,100-94-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/696b7a2e-3d2c-40ce-8895-4cd687a8f3f1/documents/28cb1aa5-f14b-4e67-8a88-763f2980d480_f17f607d-9704-42bc-ad67-f01ae9da87f2.html,,oral,LD50,"1,815 mg/kg bw",adverse effect observed, Dibenzyldimethylammonium chloride,100-94-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/696b7a2e-3d2c-40ce-8895-4cd687a8f3f1/documents/28cb1aa5-f14b-4e67-8a88-763f2980d480_f17f607d-9704-42bc-ad67-f01ae9da87f2.html,,inhalation,discriminating conc.,"43,360 mg/m3",no adverse effect observed, Dibismuth carbonate dioxide,5892-10-4," The NOAEL was determined to be 1000 mg/kg bw/day for male and female rats in a 90 day repeated dose study (OECD 408) via the oral route with read-across substance, bismuth subnitrate. By read across, bismuth subcarbonate is predicted to present no adverse effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03bbdbeb-5262-44d6-ae7c-35c081568329/documents/3294a706-ede3-4520-8e42-34943a2386e6_6aa9b1fc-732c-412b-80a5-407885c5b0ab.html,,,,,, Dibismuth carbonate dioxide,5892-10-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03bbdbeb-5262-44d6-ae7c-35c081568329/documents/3294a706-ede3-4520-8e42-34943a2386e6_6aa9b1fc-732c-412b-80a5-407885c5b0ab.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dibismuth carbonate dioxide,5892-10-4," Bismuth subcarbonate is not acutely toxic via the oral route based on read-across to related substance, bismuth subsalicylate. By read across, bismuth subcarbonate is not acutely toxic via the inhalation route. Acute toxicity via the dermal route was not tested. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03bbdbeb-5262-44d6-ae7c-35c081568329/documents/86d8b335-1dbb-4d21-b9bd-b10a8e9ba797_6aa9b1fc-732c-412b-80a5-407885c5b0ab.html,,,,,, Dibismuth carbonate dioxide,5892-10-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03bbdbeb-5262-44d6-ae7c-35c081568329/documents/86d8b335-1dbb-4d21-b9bd-b10a8e9ba797_6aa9b1fc-732c-412b-80a5-407885c5b0ab.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dibismuth carbonate dioxide,5892-10-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03bbdbeb-5262-44d6-ae7c-35c081568329/documents/86d8b335-1dbb-4d21-b9bd-b10a8e9ba797_6aa9b1fc-732c-412b-80a5-407885c5b0ab.html,,inhalation,LC50,"5,070 mg/m3",no adverse effect observed, Dibismuth trioxide,1304-76-3,"The NOAEL was determined to be 1000 mg/kg bw/day for male and female rats in a 90 day repeated dose study (OECD 408) via the oral route with read-across substance, bismuth subnitrate. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43cdce9d-9727-49a3-bc82-7f4f2c7407eb/documents/IUC5-6fc07db3-13b0-4b8a-a15c-87ee9f7107d0_760d99d6-c515-494c-8d46-c537d81d4a71.html,,,,,, Dibismuth trioxide,1304-76-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43cdce9d-9727-49a3-bc82-7f4f2c7407eb/documents/IUC5-6fc07db3-13b0-4b8a-a15c-87ee9f7107d0_760d99d6-c515-494c-8d46-c537d81d4a71.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dibismuth trioxide,1304-76-3,"Dibismuth trioxide is not acute toxic via oral, dermal or inhalation route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43cdce9d-9727-49a3-bc82-7f4f2c7407eb/documents/IUC5-813c0bb7-f905-4a4d-b4ba-09f21a647046_760d99d6-c515-494c-8d46-c537d81d4a71.html,,,,,, Dibismuth trioxide,1304-76-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43cdce9d-9727-49a3-bc82-7f4f2c7407eb/documents/IUC5-813c0bb7-f905-4a4d-b4ba-09f21a647046_760d99d6-c515-494c-8d46-c537d81d4a71.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dibismuth trioxide,1304-76-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43cdce9d-9727-49a3-bc82-7f4f2c7407eb/documents/IUC5-813c0bb7-f905-4a4d-b4ba-09f21a647046_760d99d6-c515-494c-8d46-c537d81d4a71.html,,inhalation,LC50,"5,070 mg/m3",no adverse effect observed, Dibismuth trisulphide,1345-07-9,"No 28-day or 90-day repeated dose toxicity study was available for dibismuth trisulfide. Since bismuth and dibismuth trisulfide represent both almost insoluble inorganic compounds and exhibit comparable properties the most reliable study from bismuth was used for read-across. In a 28 -day study in rats the NOEL for bismuth was determined to be 1000 mg/kg bw for males and females. Calculated for dibismuth trisulfide the NOEL was 1230 mg/kg bw for males and females.A non-GLP 14-day oral gavage dose range finding study on dibismuth trisulphide is available and supports the above derived value. In addition also an OECD 421 study with dibismuth trisulfide in pregnant animals supports the very low systemic toxicity of this compound.In accordance with column 2 of REACH Regulation EC (No) 1907/2006 Annex IX, section 8.6, the test on repeated dose toxicity after inhalation and repeated dose toxicity after dermal exposure do not need to be conducted as a repeated dose toxicity study for oral application is available. In addition also a OECD 421 study with dibismuth trisulfide in pregnant animals showed the very low systemic toxics of this compound. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8de8dd6-a8de-4cea-817b-023b6f65a4c0/documents/IUC5-26cd6fce-c656-4b9d-93a2-cc1b02b8155c_f0771c21-5a7a-4936-87d6-f46fb9a9ada5.html,,,,,, Dibismuth trisulphide,1345-07-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8de8dd6-a8de-4cea-817b-023b6f65a4c0/documents/IUC5-26cd6fce-c656-4b9d-93a2-cc1b02b8155c_f0771c21-5a7a-4936-87d6-f46fb9a9ada5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,230 mg/kg bw/day",,rat Dibismuth trisulphide,1345-07-9,"The acute toxicity of dibismuth trisulfide was determined according to OECD guideline 423 in rats. The LD50 was higher than 2000 mg/kg bw. According to the current EU Regulation on classification, labelling and packaging (CLP) (EC) No 1272/2008 or Directive 67/548/EEC (DSD) criteria no classification is required for the test item dibismuth trisulfide. Supporting data from bismuth confirm this conclusion.Under the conditions of the present Acute Inhalation Toxicity Study according to OECD guideline 403, no deaths occurred in a group of ten rats exposed for four hours to a mean achieved atmospheric test item aerosol concentration of 5.20 mg/L. The acute inhalation median lethal concentration (4hr LC50) of test item dibismuth trisulfide, in Wistar Crl:(WI) BR rats, was therefore considered to be greater than 5.20 mg/L. Based on the result of this inhalation toxicity study, dibismuth trisulfide was not classified according to the Globally Harmonized Classification System (GHS) and Regulation (EC) No 12727/2008 (CLP).In an acute dermal toxicity study with the test item dibismuth trisulfide according to OECD guideline 402, the obtained acute dermal LD50 value was above 2000 mg/kg bw in male and female Crl:(WI)BR rats. According to the results from the acute dermal toxicity study, no classification and labelling is required according to Regulation No (EC) 1272/2008 (CLP) or Directive 67/548/EEC (DSD) criteria. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8de8dd6-a8de-4cea-817b-023b6f65a4c0/documents/IUC5-59c44482-a783-45c9-8a1a-1eeb29825a51_f0771c21-5a7a-4936-87d6-f46fb9a9ada5.html,,,,,, Diboron calcium tetraoxide,13701-64-9," Numerous studies have demonstrated the toxicokinetics of boric acid and borate salts in humans and experimental animals. At physiological pHs in the aqueous layer of mucosal surfaces, prior to absorption, simple inorganic borated salts are hydrolysed to undissociated boric acid, which are readily absorbed via oral and inhalation exposure. Boric acid is not expected to hydrolyse/react further due to the high energy required to break the B – O bond. Therefore, it is expected that there will be negligible parent compound, calcium metaborate, available systemically and boric acid will be the dominant and common compound in humans and experimental animals. Therefore, a read-across approach using boric acid data is considered appropriate to use, refer to Section 13. In a read-across 2-year dietary study in Sprague Dawley rats (35/sex/treated group and 70 controls/sex) with interim kills of 5/sex/group at 6 and 12 months, rats were fed 0, 33 (5.9), 100 (17.5), 334 (58.5) mg boric acid (B)/kg bw/day. No adverse effects were observed in the low and mid-dose group. In the top dose group clinical signs, such as coarse hair coats, hunched position, swollen pads and inflamed bleeding eyes were reported. Survival at 6, 12 and 24 months was comparable in all groups including controls. Reduced body weight gain and reduced food intake were identified in the top dose group and significantly decreased red cell volume and haemoglobin were reported in top-dose males at 3, 6, 12, 18 and 24 months. Testes weights and the testes/bodyweight ratios were significantly lower compared to the controls and microscopic examination of the tissue revealed atrophied seminiferous epithelium and decreased tubular size in the testes. Based on these effects a NOAEL of 100 mg/kg bw/day (17.5 mg B/kg bw/day (nominal)) was identified for the source substance, boric acid. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/461ad87d-2c0f-4ce0-9564-abfea8e04ffb/documents/1e424821-55a9-406d-8859-a45130939cdc_54c8ce00-0b23-4dba-9541-de5ad2052a13.html,,,,,, Diboron calcium tetraoxide,13701-64-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/461ad87d-2c0f-4ce0-9564-abfea8e04ffb/documents/1e424821-55a9-406d-8859-a45130939cdc_54c8ce00-0b23-4dba-9541-de5ad2052a13.html,Chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Diboron calcium tetraoxide,13701-64-9," Numerous studies have demonstrated the toxicokinetics of boric acid and borate salts in humans and experimental animals. At physiological pHs in the aqueous layer of mucosal surfaces, prior to absorption, simple inorganic borated salts are hydrolysed to undissociated boric acid, which are readily absorbed via oral and inhalation exposure. Boric acid is not expected to hydrolyse/react further due to the high energy required to break the B – O bond. Therefore, it is expected that there will be negligible parent compound, calcium metaborate, available systemically and boric acid will be the dominant and common compound in humans and experimental animals. Therefore, a read-across approach using boric acid data is considered appropriate to use, refer to Section 13. According to an OECD Guideline 401 (Acute Oral Toxicity) in male rats an oral LD50 value for the source substance, anhydrous boric acid, was established >2600 mg/kg bw. According to a standard acute oral study method, conducted pre-GLP, the LD50 values of boric acid in male and female albino rats were 3450 and 4080 mg/kg bw, respectively, the mean LD50 was 3765 mg/kg bw. According to a FIFRA (40 CFR 163) acute dermal study in male and female New Zealand White rabbits a dermal LD50 value for the source substance, boric acid, was established >2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/461ad87d-2c0f-4ce0-9564-abfea8e04ffb/documents/72560dc5-6ffe-4e9c-b5f9-e6ab3094c9a3_54c8ce00-0b23-4dba-9541-de5ad2052a13.html,,,,,, Diboron calcium tetraoxide,13701-64-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/461ad87d-2c0f-4ce0-9564-abfea8e04ffb/documents/72560dc5-6ffe-4e9c-b5f9-e6ab3094c9a3_54c8ce00-0b23-4dba-9541-de5ad2052a13.html,,oral,LD50,"3,765 mg/kg bw",no adverse effect observed, Diboron calcium tetraoxide,13701-64-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/461ad87d-2c0f-4ce0-9564-abfea8e04ffb/documents/72560dc5-6ffe-4e9c-b5f9-e6ab3094c9a3_54c8ce00-0b23-4dba-9541-de5ad2052a13.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dibromomethane,74-95-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b9cbb59-0a1a-4b8a-8339-0fc9e4a59916/documents/202ab0f4-9625-420b-a54d-40b015b0d3e9_40f08411-0334-4d9b-82c5-64438c733c4d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,8.6 mg/kg bw/day,, Dibromomethane,74-95-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b9cbb59-0a1a-4b8a-8339-0fc9e4a59916/documents/202ab0f4-9625-420b-a54d-40b015b0d3e9_40f08411-0334-4d9b-82c5-64438c733c4d.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,180 mg/m3,, Dibromomethane,74-95-3," LC50 Rat ihl 40 g/cu m/2 hr [Lewis, R.J. Sax's Dangerous Properties of Industrial Materials. 9th ed. Volumes 1-3. New York, NY: Van Nostrand Reinhold, 1996., p. 1066] **PEER REVIEWED** LD50 Mouse sc 3738 mg/kg [Lewis, R.J. Sax's Dangerous Properties of Industrial Materials. 9th ed. Volumes 1-3. New York, NY: Van Nostrand Reinhold, 1996., p. 1066] **PEER REVIEWED** ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b9cbb59-0a1a-4b8a-8339-0fc9e4a59916/documents/e3a3d5e1-a335-4521-b2d4-9412e1973529_40f08411-0334-4d9b-82c5-64438c733c4d.html,,,,,, Dibromomethane,74-95-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b9cbb59-0a1a-4b8a-8339-0fc9e4a59916/documents/e3a3d5e1-a335-4521-b2d4-9412e1973529_40f08411-0334-4d9b-82c5-64438c733c4d.html,,oral,LD50,"1,000 mg/kg bw",, Dibromomethane,74-95-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b9cbb59-0a1a-4b8a-8339-0fc9e4a59916/documents/e3a3d5e1-a335-4521-b2d4-9412e1973529_40f08411-0334-4d9b-82c5-64438c733c4d.html,,inhalation,,22.3 mg/m3,, "Dibromopyranthrene-8,16-dione",1324-35-2, LD50 > 10000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8b4f64d-cf90-427d-8395-a862fd145895/documents/f4819dec-3970-4ed3-8606-d23f8d2ca667_242b03ed-5f80-48c1-a1b7-6221e7ed9e6c.html,,,,,, Dibutoxy(dimethyl)silane,1591-02-2,"The key study for acute oral toxicity reports an LD50 of >2000 mg/kg bw for rats in a study conducted according OECD TG 423 and in compliance with GLP (BSL Bioservice, 2015a). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09acf137-ce92-421b-a41c-f8782a1878ee/documents/IUC5-372cd969-e94b-48f7-8a22-1396d8111de6_fae98d88-841d-49a4-b907-c2cb42bdf3af.html,,,,,, Dibutoxy(dimethyl)silane,1591-02-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09acf137-ce92-421b-a41c-f8782a1878ee/documents/IUC5-372cd969-e94b-48f7-8a22-1396d8111de6_fae98d88-841d-49a4-b907-c2cb42bdf3af.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dibutoxydibutylstannane,3349-36-8,"The following studies have been submitted to address the repeated dose toxicity: oral endpoint:Waalkens-Berendsen DH (2003) Dibutyldichlorostannane (CAS # 683-18-1): Reproduction/developmental toxicity screening test in rats, TNO, Project Organisation, Ecotoxicology, Utrechtseweg 48, P.O. Box 370, 3700 AJ Zeist, The Netherlands, Report No.: V 4906, Organotin Environmental Programme (ORTEP) Association, Stabilizer Task Force. Report Date.: 2003-12-04. studBarnes, J. M. and Stoner, H. B. (1958). Toxic properties of some dialkyl and trialkyl tin salts. Brit. J. Industr. Med., 1958, 15, 15.Gaunt et al (1968). Acute and Short-term Toxicity Studies on Di-n-butyltin Dichloride in Rats. Fd Cosmet. Toxicol. Vol. 6, pp. 599-608.Penninks A. H. & Seinen W. (1982). COMPARATIVE TOXICITY OF ALKYLTIN AND ESTERTIN STABILIZERS. Fd Chem. Toxic. Vol. 20. pp. 909 to 916.The Gaunt et al (1968) study has been allocated a Klimisch core of 2 on the basis that the study predates GLP; however, method was comparable to OECD Guideline 408. The effect of DBT exposure on the thymus was not assessed in this study. No information on the stability or homogeneity of the test material in the DBTC-prepared diets. The study was performed with dibutyltin dichloride.The Penninks and Seinen (1982) study has also been allocated a Klimisch score of 2 on the basis that the study is a short-term feeding study with no information on the stability of the test substance in the diet or homogeneity of the test diets provided. The purity of the test substance (dibutyltin dichloride) is not reported. The Barnes and Stoner (1958) study has been allocated a Klimisch score of 4.Dibutyltin chloride was the test substance employed in all the studies presented under repeated dose toxicity. Under gastric conditions, the substance in question is anticipated to hydrolyse to dibutyltin chloride. A read-across approach from dibutyltin chloride was considered acceptable when dosing repeatedly via the oral route. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7be2d05-80e7-4065-a141-0ca03e54ac2f/documents/IUC5-122b3f70-e834-4cbd-9494-ff97432f7438_909d4d2b-c0d2-4b4f-a688-d1a7b5ecc047.html,,,,,, Dibutoxydibutylstannane,3349-36-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7be2d05-80e7-4065-a141-0ca03e54ac2f/documents/IUC5-122b3f70-e834-4cbd-9494-ff97432f7438_909d4d2b-c0d2-4b4f-a688-d1a7b5ecc047.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.3 mg/kg bw/day,,rat Dibutoxydibutylstannane,3349-36-8,"Oral:Sanders, A 2010; ACUTE ORAL TOXICITY IN THE RAT - FIXED DOSE METHOD; Testing Laboratory: Harlan Laboratories Limited, Shardlow Business Park, Shardlow, Derbyshire, DE72 2GD, UK. Owner company: Chemtura Corporation, 199 Benson Road, Middlebury, CONNECTICUT 06749, UNITED STATES OF AMERICA. Project No.: 3103/0038.The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (OECD 420).Dermal:Sanders, A 2010; ACUTE DERMAL TOXICITY (LIMIT TEST) IN THE RAT; Testing Laboratory: Harlan Laboratories Limited, Shardlow Business Park, Shardlow, Derbyshire, DE72 2GD, UK. Owner company: Chemtura Corporation, 199 Benson Road, Middlebury, CONNECTICUT 06749, UNITED STATES OF AMERICA. Project No.: 41003850.The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat could not be deterimined as no animals died from dermal toxicity at the tested does, however due to severe/corrosive dermal reactions the animals were killed for humane reasons at 7 days. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7be2d05-80e7-4065-a141-0ca03e54ac2f/documents/IUC5-60d8391d-3d15-443e-a4d0-4cdfcf17cfeb_909d4d2b-c0d2-4b4f-a688-d1a7b5ecc047.html,,,,,, Dibutoxydibutylstannane,3349-36-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7be2d05-80e7-4065-a141-0ca03e54ac2f/documents/IUC5-60d8391d-3d15-443e-a4d0-4cdfcf17cfeb_909d4d2b-c0d2-4b4f-a688-d1a7b5ecc047.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dibutyl [(dipropoxyphosphinothioyl)thio]succinate,68413-47-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2316a73-694a-4fc4-9739-14b0d81f79e1/documents/be721c92-58c1-45d0-bbae-a616817fafb3_a6f1c738-d709-4f72-a5a9-ce9e83f4b10c.html,,,,,, Dibutyl [(dipropoxyphosphinothioyl)thio]succinate,68413-47-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2316a73-694a-4fc4-9739-14b0d81f79e1/documents/be721c92-58c1-45d0-bbae-a616817fafb3_a6f1c738-d709-4f72-a5a9-ce9e83f4b10c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Dibutyl [(dipropoxyphosphinothioyl)thio]succinate,68413-47-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2316a73-694a-4fc4-9739-14b0d81f79e1/documents/a6078e70-7730-4557-a447-85055bf2ffd7_a6f1c738-d709-4f72-a5a9-ce9e83f4b10c.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Dibutyl [[bis[(2-ethylhexyl)oxy]phosphinothioyl]thio]succinate,68413-48-9," The potential toxic effects of the test substance were investigated in an OECD 422 study, performed under GLP conditions. The test substance was administered to rats for at least 28 days in the vehicle (corn oil) via gavage once daily to 3 groups of Crl:CD(SD) rats, each group consisting of 10 males and 10 females.  Under the conditions of this screening study, no adverse effects were noted in F0 adults at any dosage level. Therefore, a dosage level of 1000 mg/kg/day (the highest dosage level tested) was considered to be the no-observed-adverse-effect level (NOAEL) for F0 repeated dose toxicity and systemic toxicity of the test substance when administered orally by gavage to Crl:CD(SD) rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10b5cf19-8b23-4263-9d31-82a00afd326f/documents/d5f4b0c0-df68-44b7-84b6-3a4f5cd2a312_5887df24-a4c8-4a8b-b25b-f29e2abefee2.html,,,,,, Dibutyl [[bis[(2-ethylhexyl)oxy]phosphinothioyl]thio]succinate,68413-48-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10b5cf19-8b23-4263-9d31-82a00afd326f/documents/d5f4b0c0-df68-44b7-84b6-3a4f5cd2a312_5887df24-a4c8-4a8b-b25b-f29e2abefee2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dibutyl [[bis[(2-ethylhexyl)oxy]phosphinothioyl]thio]succinate,68413-48-9," Oral Key study: In an acute oral gavage study in male rats performed under conditions similar to the OECD 401 guideline, the LD50 of the test material was 11300 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10b5cf19-8b23-4263-9d31-82a00afd326f/documents/6b25a06e-3099-465a-9822-9888d5ebca9c_5887df24-a4c8-4a8b-b25b-f29e2abefee2.html,,,,,, Dibutyl [[bis[(2-ethylhexyl)oxy]phosphinothioyl]thio]succinate,68413-48-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10b5cf19-8b23-4263-9d31-82a00afd326f/documents/6b25a06e-3099-465a-9822-9888d5ebca9c_5887df24-a4c8-4a8b-b25b-f29e2abefee2.html,,oral,LD50,"11,300 mg/kg bw",adverse effect observed, Dibutyl ether,142-96-1,Repeated dose toxicity studies by the inhalation and oral route are available. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad724a2c-c7ac-4ce3-914d-b02306a7c9f1/documents/a3992e8b-0dfa-48d9-9cb8-5d50c22c77cf_09e31962-9da3-4301-b551-fd1a89c491d2.html,,,,,, Dibutyl ether,142-96-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad724a2c-c7ac-4ce3-914d-b02306a7c9f1/documents/a3992e8b-0dfa-48d9-9cb8-5d50c22c77cf_09e31962-9da3-4301-b551-fd1a89c491d2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Dibutyl ether,142-96-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad724a2c-c7ac-4ce3-914d-b02306a7c9f1/documents/a3992e8b-0dfa-48d9-9cb8-5d50c22c77cf_09e31962-9da3-4301-b551-fd1a89c491d2.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,500 mg/m3,,rat Dibutyl ether,142-96-1,"There are no studies according to current guidelines available. But there are non-guideline studies on hand, which are adequately documented and considered to be of sufficient quality to allow an evaluation of this endpoint. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad724a2c-c7ac-4ce3-914d-b02306a7c9f1/documents/77ffab41-5c47-4074-a988-3283f4e6a168_09e31962-9da3-4301-b551-fd1a89c491d2.html,,,,,, Dibutyl ether,142-96-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad724a2c-c7ac-4ce3-914d-b02306a7c9f1/documents/77ffab41-5c47-4074-a988-3283f4e6a168_09e31962-9da3-4301-b551-fd1a89c491d2.html,,oral,LD50,"7,400 mg/kg bw",no adverse effect observed, Dibutyl ether,142-96-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad724a2c-c7ac-4ce3-914d-b02306a7c9f1/documents/77ffab41-5c47-4074-a988-3283f4e6a168_09e31962-9da3-4301-b551-fd1a89c491d2.html,,dermal,LD50,"7,741 mg/kg bw",no adverse effect observed, Dibutyl ether,142-96-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad724a2c-c7ac-4ce3-914d-b02306a7c9f1/documents/77ffab41-5c47-4074-a988-3283f4e6a168_09e31962-9da3-4301-b551-fd1a89c491d2.html,,inhalation,LC50,"21,600 mg/m3",no adverse effect observed, Dibutyl fumarate,105-75-9,The NOAEL for systemic effects of dibutyl fumarate administered by oral gavage to Wistar rats for 90 consecutive days is 50 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/271185a8-de60-48b8-bcea-fef3557ec9f5/documents/IUC5-e7474c78-fb95-4fe5-b33c-6548292a34ca_801fee48-df6c-41ec-943b-c8ac4960c013.html,,,,,, Dibutyl fumarate,105-75-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/271185a8-de60-48b8-bcea-fef3557ec9f5/documents/IUC5-e7474c78-fb95-4fe5-b33c-6548292a34ca_801fee48-df6c-41ec-943b-c8ac4960c013.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Dibutyl fumarate,105-75-9,"The oral LD50 in the rat was 8530 mg/kg bw. The dermal LD50 in the rabbit was 15.9 mL/kg bw; considering the relative density of 0.9837, this corresponds to 15600 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/271185a8-de60-48b8-bcea-fef3557ec9f5/documents/IUC5-53f0f96a-8e88-4bcc-8a9c-e5bb33dfa4c2_801fee48-df6c-41ec-943b-c8ac4960c013.html,,,,,, Dibutyl fumarate,105-75-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/271185a8-de60-48b8-bcea-fef3557ec9f5/documents/IUC5-53f0f96a-8e88-4bcc-8a9c-e5bb33dfa4c2_801fee48-df6c-41ec-943b-c8ac4960c013.html,,oral,LD50,"8,530 mg/kg bw",adverse effect observed, Dibutyl fumarate,105-75-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/271185a8-de60-48b8-bcea-fef3557ec9f5/documents/IUC5-53f0f96a-8e88-4bcc-8a9c-e5bb33dfa4c2_801fee48-df6c-41ec-943b-c8ac4960c013.html,,dermal,LD50,"15,600 mg/kg bw",no adverse effect observed, Dibutyl fumarate,105-75-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/271185a8-de60-48b8-bcea-fef3557ec9f5/documents/IUC5-53f0f96a-8e88-4bcc-8a9c-e5bb33dfa4c2_801fee48-df6c-41ec-943b-c8ac4960c013.html,,inhalation,discriminating conc.,15.4 mg/m3,no adverse effect observed, Dibutyl hydrogen phosphate,107-66-4,"In an OECD combined repeat dose and reproductive/developmental toxicity screening test (OECD TG 422) with dibutyl hydrogen phosphate, histopathology showed epithelial hyperplasia accompanied by degeneration and ulceration of the urinary bladder mucosa in males and females with >= 100 mg/kg bw. The NOEL was established with 30 mg/kg bw for both sexes, based on these effects in the bladder. In a 90 day feeding study with the source tributyl phosphate in CD-1 mice at concentrations of 0, 500, 2000, or 8000 ppm all animals survived. Body weight loss and reduced body gain, elevation of absolute and relative liver weights with hepatocyte hypertrophy, slight to moderate epithelial hyperplasia of the urinary bladder were seen at the highest dose. In the mid dose moderately elevated liver weights in both sexes, slight hepatocyte hypertrophy and minimal or slight epithelial hyperplasia of the urinary bladder. No effects of test material administration were evident in animals receiving the lowest concentration (500 ppm). The NOEL was thus determined with 500 ppm, according to 75 mg/kg bw/day. In a chronic feeding study on SD rats with the source tributyl phosphate a dose-related increase in the incidence and severity of urinary bladder hyperplasia and the incidence of urinary bladder papillomas was evident in male and female rats receiving the 700 and 3000 ppm concentrations. Based on these effects the no observed effect level (NOEL) for chronic oral administration of tributyl phosphate to rats under conditions of this study was 200 ppm (200 ppm = 8.9 mg/kg bw for males and 11.6 mg/kg bw for females). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The materials/methods and results are described in detail und are sufficient for evaluation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a920ace3-11d4-4002-b571-ec9b208603fa/documents/IUC5-0e8f6fee-e0ec-4bce-882d-19a2397c7765_a8fbe376-4cf1-471e-a7e1-760d5462edc3.html,,,,,, Dibutyl hydrogen phosphate,107-66-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a920ace3-11d4-4002-b571-ec9b208603fa/documents/IUC5-0e8f6fee-e0ec-4bce-882d-19a2397c7765_a8fbe376-4cf1-471e-a7e1-760d5462edc3.html,Chronic toxicity – systemic effects,oral,NOAEL,8.9 mg/kg bw/day,,rat Dibutyl hydrogen phosphate,107-66-4,"A valid oral toxicity study according OECD 401 is available that shows an LD50 of > 2000 mg/kg bw.In a valid in-vitro corrosion test according OECD TG 431, dibutyl hydrogen phosphate was corrosive. Therefore an acute inhalation and dermal toxicity study does not need to be conducted according REACH Annex VII column 2. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The materials/methods and results are described in detail und are sufficient for evaluation. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a920ace3-11d4-4002-b571-ec9b208603fa/documents/IUC5-4404d722-26f4-4579-bbcd-6f45aa119df7_a8fbe376-4cf1-471e-a7e1-760d5462edc3.html,,,,,, Dibutyl hydrogen phosphate,107-66-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a920ace3-11d4-4002-b571-ec9b208603fa/documents/IUC5-4404d722-26f4-4579-bbcd-6f45aa119df7_a8fbe376-4cf1-471e-a7e1-760d5462edc3.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, Dibutyl itaconate,2155-60-4,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyInformation.KeyInformation): A reliable 90-day repeated dose toxicity study is available (performed according to OECD test guideline 408 and in accordance with GLP principles). Administration of the test material by once daily oral gavage was well tolerated in Wistar Han rats up to 1000 mg/kg bw/day. There were no adverse test material related alterations observed. The no-observed-adverse-effect level (NOAEL) was considered to be at least 1000 mg/kg bw/day in males and females.Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Performed according to OECD guideline and in accordance with GLP principles (Klimisch 1). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f3d8b49-3abf-423b-8a95-7fde7e6d2775/documents/a0637acc-d64a-49c0-ae91-b116b61aee7d_c7f9d378-e6bd-4390-bd06-c2d7a81c7bd1.html,,,,,, Dibutyl itaconate,2155-60-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f3d8b49-3abf-423b-8a95-7fde7e6d2775/documents/a0637acc-d64a-49c0-ae91-b116b61aee7d_c7f9d378-e6bd-4390-bd06-c2d7a81c7bd1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dibutyl itaconate,2155-60-4," An acute oral toxicity study was performed with rats, performed according to OECD/EC test guidelines. In this study an oral LD50 >2000 mg/kg bw was determined. Based on the physico-chemical properties and based on all other data available, performance of acute studies with other expsoure routes were waived. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f3d8b49-3abf-423b-8a95-7fde7e6d2775/documents/dfca3c90-2420-4ea4-8192-c181dab6b8dc_c7f9d378-e6bd-4390-bd06-c2d7a81c7bd1.html,,,,,, Dibutyl methylenedithiodi(acetate),14338-82-0,"Exposure-based waiving: Repeated-dose toxicity testing has not been performed, because no significant exposure occurs in all scenarios of manufacture and identified uses.In a worst case scenario a very conservative oral DNEL based on the TTC concept for chronic toxicity was choosen for MBTester, a Cramer class III substance (high hazard). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/229b2af0-cab5-4c62-893e-9c9162de9707/documents/IUC5-34f6ec51-f642-4821-80cc-195313e84a07_5fc17f33-cdd8-4739-92cb-a002a15656a6.html,,,,,, Dibutyl methylenedithiodi(acetate),14338-82-0,"MBTester is not toxic via the oral and dermal route. The LD50 values are greater than 10000 and 2000 mg/kg bw, respectively.Inhalation is not a relevant route of exposure because of the low vapour pressure and the lack of inhalation exposure via aerosols. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/229b2af0-cab5-4c62-893e-9c9162de9707/documents/IUC5-ae5c95a5-131f-4a03-8336-e19c0344b2c9_5fc17f33-cdd8-4739-92cb-a002a15656a6.html,,,,,, Dibutyl methylenedithiodi(acetate),14338-82-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/229b2af0-cab5-4c62-893e-9c9162de9707/documents/IUC5-ae5c95a5-131f-4a03-8336-e19c0344b2c9_5fc17f33-cdd8-4739-92cb-a002a15656a6.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, Dibutyl methylenedithiodi(acetate),14338-82-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/229b2af0-cab5-4c62-893e-9c9162de9707/documents/IUC5-ae5c95a5-131f-4a03-8336-e19c0344b2c9_5fc17f33-cdd8-4739-92cb-a002a15656a6.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Dibutyl peroxydicarbonate,16215-49-9," Dibutyl peroxydicarbonate was tested in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422). Dose groups were based on the results of a 14-day dose range finding study. No adverse effects were found on male and female mortality, clinical observations, functional observations, body weight development (except HD males), food consumption, estrous cyclicity, hematology and coagulation, clinical biochemistry, urinalysis and gross macroscopic findings at necropsy in all treatment groups. There were test item related effects on body weight development in HD males and histopathology in the HD group treated with 1000 mg/kg body weight/day. Based on the results, the NOAEL for repeated dose toxicity is considered to be 300 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0715bca-41c6-4bbd-b943-b9f00d305ce6/documents/8d1e5197-4cc7-4a03-af02-267622e1f8f9_dc89f107-1291-4e27-a9d8-ff7a91ab741e.html,,,,,, Dibutyl peroxydicarbonate,16215-49-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0715bca-41c6-4bbd-b943-b9f00d305ce6/documents/8d1e5197-4cc7-4a03-af02-267622e1f8f9_dc89f107-1291-4e27-a9d8-ff7a91ab741e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Dibutyl peroxydicarbonate,16215-49-9," Suitable data are available to assess the acute oral toxicity of the target substance dibutyl peroxydicarbonate. In an acute oral toxicity study conducted similar to OECD 401, Wistar rats (10/sex) were orally exposed to 10 mL/kg bw test item. Based on the results, the oral LD50 can be considered to exceed 10 mL/kg bw (equals 8800 mg/kg bw). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0715bca-41c6-4bbd-b943-b9f00d305ce6/documents/0e4a5caa-141b-4b7e-a004-db08d8cb9dfa_dc89f107-1291-4e27-a9d8-ff7a91ab741e.html,,,,,, Dibutyl phosphonate,1809-19-4,"NOAEL (oral; sub-chronic; rat) = 500 mg/kg bw/day NOAEC (inhalation; chronic; rat) = 0.13 mg/L air (corresponding to 1000 ppm, analytical concentration) NOAEL (dermal; sub-acute; rat) = 20 mL/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a63be90-cd7d-4c7b-8e4c-bb4d4b3c9fd8/documents/IUC5-46491bec-1e75-40aa-85ca-6dd94156f296_3b48b35f-9224-4290-b98f-e922c10bbdd1.html,,,,,, Dibutyl phosphonate,1809-19-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a63be90-cd7d-4c7b-8e4c-bb4d4b3c9fd8/documents/IUC5-46491bec-1e75-40aa-85ca-6dd94156f296_3b48b35f-9224-4290-b98f-e922c10bbdd1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Dibutyl phosphonate,1809-19-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a63be90-cd7d-4c7b-8e4c-bb4d4b3c9fd8/documents/IUC5-46491bec-1e75-40aa-85ca-6dd94156f296_3b48b35f-9224-4290-b98f-e922c10bbdd1.html,Chronic toxicity – systemic effects,inhalation,NOAEC,0.13 mg/m3,,rat Dibutyl phosphonate,1809-19-4," LD50 (oral, rat) > 3000 mg/kg bw LC0 (inhalation, rat, 1h) = 22.53 mg/L LD50 (dermal, rabbit) = 5000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a63be90-cd7d-4c7b-8e4c-bb4d4b3c9fd8/documents/IUC5-542b0bef-1e8a-4376-bfef-1e85e3a4515b_3b48b35f-9224-4290-b98f-e922c10bbdd1.html,,,,,, Dibutyl phosphonate,1809-19-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a63be90-cd7d-4c7b-8e4c-bb4d4b3c9fd8/documents/IUC5-542b0bef-1e8a-4376-bfef-1e85e3a4515b_3b48b35f-9224-4290-b98f-e922c10bbdd1.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, Dibutyl phosphonate,1809-19-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a63be90-cd7d-4c7b-8e4c-bb4d4b3c9fd8/documents/IUC5-542b0bef-1e8a-4376-bfef-1e85e3a4515b_3b48b35f-9224-4290-b98f-e922c10bbdd1.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Dibutyl phosphonate,1809-19-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a63be90-cd7d-4c7b-8e4c-bb4d4b3c9fd8/documents/IUC5-542b0bef-1e8a-4376-bfef-1e85e3a4515b_3b48b35f-9224-4290-b98f-e922c10bbdd1.html,,inhalation,LC50,"22,530 mg/m3",no adverse effect observed, Dibutyl terephthalate,1962-75-0,"A subchronic oral gavage study in rats with the read-across chemical, n-butanol, indicates CNS depression as the critical effect of exposure. A number of dietary studies with the read-across chemical, terephthalic acid, indicate the urinary tract as the target organ following repeated exposures. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/131581a9-9ba6-4c7c-933d-ef1fcf8c458e/documents/IUC5-9e663209-0313-46dc-99c6-f7795b6c6475_69b9d49d-5ed2-40e4-9a75-373bbde0f881.html,,,,,, Dibutyl terephthalate,1962-75-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/131581a9-9ba6-4c7c-933d-ef1fcf8c458e/documents/IUC5-9e663209-0313-46dc-99c6-f7795b6c6475_69b9d49d-5ed2-40e4-9a75-373bbde0f881.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,10.05 mg/m3,,rat Dibutyl terephthalate,1962-75-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/131581a9-9ba6-4c7c-933d-ef1fcf8c458e/documents/IUC5-9e663209-0313-46dc-99c6-f7795b6c6475_69b9d49d-5ed2-40e4-9a75-373bbde0f881.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Dibutyl terephthalate,1962-75-0,Guideline acute oral and dermal toxicity studies in rats indicating a low order of acute toxicity. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/131581a9-9ba6-4c7c-933d-ef1fcf8c458e/documents/IUC5-ebbc9c5f-edb6-460f-b28c-f6a6c1d57eca_69b9d49d-5ed2-40e4-9a75-373bbde0f881.html,,,,,, Dibutyl terephthalate,1962-75-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/131581a9-9ba6-4c7c-933d-ef1fcf8c458e/documents/IUC5-ebbc9c5f-edb6-460f-b28c-f6a6c1d57eca_69b9d49d-5ed2-40e4-9a75-373bbde0f881.html,,oral,LD50,"2,000 mg/kg bw",, Dibutyl terephthalate,1962-75-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/131581a9-9ba6-4c7c-933d-ef1fcf8c458e/documents/IUC5-ebbc9c5f-edb6-460f-b28c-f6a6c1d57eca_69b9d49d-5ed2-40e4-9a75-373bbde0f881.html,,dermal,LD50,"2,000 mg/kg bw",, Dibutylamine,111-92-2,"Repeated dose toxicity - oral:  Key: NOAEL (systemic, males) = 25 mg/kg bw/day based on mortality in high dose group and multiple adverse clinical signs and/or functional observations in mid dose group, NOAEL (systemic, females) = 75 mg/kg bw/day based on mortality in high dose group, rat, OECD 408, GLP, 2023, K1   Repeated dose toxicity - inhalation:  Key: NOAEC (systemic) = 450 mg/m3, NOAEC (local) = 50 mg/m3, rat, similar to OECD 413 (guideline study, but limited to the respiratory system and reproductive organs), GLP, 2003, K2 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c11139f-bde0-43a1-9266-4aea8eb0f725/documents/IUC5-0e2051a9-056b-484f-ac9d-476ed8e4e68d_e9011dc9-af27-4294-82dc-82e52653c14e.html,,,,,, Dibutylamine,111-92-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c11139f-bde0-43a1-9266-4aea8eb0f725/documents/IUC5-0e2051a9-056b-484f-ac9d-476ed8e4e68d_e9011dc9-af27-4294-82dc-82e52653c14e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Dibutylamine,111-92-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c11139f-bde0-43a1-9266-4aea8eb0f725/documents/IUC5-0e2051a9-056b-484f-ac9d-476ed8e4e68d_e9011dc9-af27-4294-82dc-82e52653c14e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,450 mg/m3,,rat Dibutylamine,111-92-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c11139f-bde0-43a1-9266-4aea8eb0f725/documents/IUC5-0e2051a9-056b-484f-ac9d-476ed8e4e68d_e9011dc9-af27-4294-82dc-82e52653c14e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,50 mg/m3,adverse effect observed,rat Dibutylamine,111-92-2,"Acute toxicity: oral route WoE: LD50 (rat) = 189-550 mg/kg bw   Acute toxicity: dermal route Key: LD50 (rabbit) = 768 mg/kg bw, no guideline followed but according to Draize, publication, no GLP, 1954, K2   Acute toxicity: inhalation Key: LC50 (rat) = 1.15 mg/L, 4 h exposure, similar to OECD 403, GLP, 1987, K2 Sup: LC50 (rat) = 573 ppm, 1 h exposure, similar to OECD 403, GLP, 1987, K2 Sup: LC50 (rat) > 1.34 - < 2.68 mg/L, no guideline followed, publication, no GLP, 1954, K2 Sup: LC50 (rat) > 2mg/L, no guideline followed, GLP not specified, 1976, K2 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c11139f-bde0-43a1-9266-4aea8eb0f725/documents/IUC5-e6abd4be-99cd-48c8-9537-34542fa926f7_e9011dc9-af27-4294-82dc-82e52653c14e.html,,,,,, Dibutylamine,111-92-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c11139f-bde0-43a1-9266-4aea8eb0f725/documents/IUC5-e6abd4be-99cd-48c8-9537-34542fa926f7_e9011dc9-af27-4294-82dc-82e52653c14e.html,,oral,LD50,189 mg/kg bw,adverse effect observed, Dibutylamine,111-92-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c11139f-bde0-43a1-9266-4aea8eb0f725/documents/IUC5-e6abd4be-99cd-48c8-9537-34542fa926f7_e9011dc9-af27-4294-82dc-82e52653c14e.html,,dermal,LD50,768 mg/kg bw,adverse effect observed, Dibutylamine,111-92-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c11139f-bde0-43a1-9266-4aea8eb0f725/documents/IUC5-e6abd4be-99cd-48c8-9537-34542fa926f7_e9011dc9-af27-4294-82dc-82e52653c14e.html,,inhalation,LC50,"1,150 mg/m3",adverse effect observed, Dibutylbis(dodecylthio)stannane,1185-81-5,"Oral:A study was conducted to determine the potential for oral toxicity using the Acute Toxic Class Determination. This study is designed to comply with the standards set forth in OECD Guidelines for the Testing of Chemicals, Guideline 423 adopted December 17, 2001. Guideline 423 is referred to in OPPTS 870,1000 (December 2002) as an acceptable method to assess lethality within a dose range.The LD50 is greater than 2000 mg/kg of body weight in rats.Dermal:The study was conducted to determine the potential for toxicity of the test article when applied dermally and was designed to comply with the standards set forth in OECD Guidelines for Testing Chemicals, Number 402, adopted February 24, 1987.The dermal LD50 of the test material is greater than 1000 mg/kg but less than 2000 mg/kg of body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7dff5673-a244-46c6-bdbb-b7ad8b201e47/documents/d8f5dc8f-ab40-4197-adea-18c56d747683_52d95e94-6d28-41fb-b710-11201dc1e87a.html,,,,,, Dibutyldimethoxystannane,1067-55-6,"The following studies have been submitted to address the repeated dose toxicity: oral endpoint:Barnes, J. M. and Stoner, H. B. (1958). Toxic properties of some dialkyl and trialkyl tin salts. Brit. J. Industr. Med., 1958, 15, 15.Gaunt et al (1968). Acute and Short-term Toxicity Studies on Di-n-butyltin Dichloride in Rats. Fd Cosmet. Toxicol. Vol. 6, pp. 599-608.Penninks A. H. & Seinen W. (1982). COMPARATIVE TOXICITY OF ALKYLTIN AND ESTERTIN STABILIZERS. Fd Chem. Toxic. Vol. 20. pp. 909 to 916.The Gaunt et al (1968) study has been allocated a Klimisch core of 2 on the basis that the study predates GLP; however, method was comparable to OECD Guideline 408. The effect of DBT exposure on the thymus of was not assessed in this study. No information on the stability or homogeneity of the test material in the DBTC-prepared diets. The study was performed with dibutyltin dichloride.The Penninks and Seinen (1982) study has also been allocated a Klimisch score of 2 on the basis that the study is a short-term feeding study with no information on the stability of the test substance in the diet or homogeneity of the test diets provided. The purity of the test substance (dibutyltin dichloride) is not reported.The Barnes and Stoner (1958) study has been allocated a Klimisch score of 4.Dibutyltin chloride was the test substance employed in all the studies presented under repeated dose toxicity. Under gastric conditions, dibutyltin dimethoxystannane is anticipated to hydrolyse to dibutyltin chloride. A read-across approach from dibutyltin chloride was considered acceptable when dosing repeatedly via the oral route. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/407fe53c-a204-4b66-9456-72ef0a2a21eb/documents/IUC5-383a2dd5-b067-48eb-afe4-9f1d7ce208ce_ff6bb09c-47d8-4d9b-8d2e-b747434752a8.html,,,,,, Dibutyldimethoxystannane,1067-55-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/407fe53c-a204-4b66-9456-72ef0a2a21eb/documents/IUC5-383a2dd5-b067-48eb-afe4-9f1d7ce208ce_ff6bb09c-47d8-4d9b-8d2e-b747434752a8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,2 mg/kg bw/day,,rat Dibutyltin maleate,78-04-6,"The following studies have been submitted to address the repeated dose toxicity: oral endpoint:Waalkens-Berendsen DH (2003) Dibutyldichlorostannane (CAS # 683-18-1): Reproduction/developmental toxicity screening test in rats, TNO, Project Organisation, Ecotoxicology, Utrechtseweg 48, P.O. Box 370, 3700 AJ Zeist, The Netherlands, Report No.: V 4906, Organotin Environmental Programme (ORTEP) Association, Stabilizer Task Force. Report Date.: 2003-12-04.Barnes, J. M. and Stoner, H. B. (1958). Toxic properties of some dialkyl and trialkyl tin salts. Brit. J. Industr. Med., 1958, 15, 15.Gaunt et al (1968). Acute and Short-term Toxicity Studies on Di-n-butyltin Dichloride in Rats. Fd Cosmet. Toxicol. Vol. 6, pp. 599-608.Penninks A. H. & Seinen W. (1982). COMPARATIVE TOXICITY OF ALKYLTIN AND ESTERTIN STABILIZERS. Fd Chem. Toxic. Vol. 20. pp. 909 to 916.The Gaunt et al (1968) study has been allocated a Klimisch core of 2 on the basis that the study predates GLP; however, method was comparable to OECD Guideline 408. The effect of DBT exposure on the thymus of was not assessed in this study. No information on the stability or homogeneity of the test material in the DBTC-prepared diets. The study was performed with dibutyltin dichloride.The Penninks and Seinen (1982) study has also been allocated a Klimisch score of 2 on the basis that the study is a short-term feeding study with no information on the stability of the test substance in the diet or homogeneity of the test diets provided. The purity of the test substance (dibutyltin dichloride) is not reported. The Barnes and Stoner (1958) study has been allocated a Klimisch score of 4.Dibutyltin chloride was the test substance employed in all the studies presented under repeated dose toxicity. Under gastric conditions, the substance in question is anticipated to hydrolyse to dibutyltin chloride. A read-across approach from dibutyltin chloride was considered acceptable when dosing repeatedly via the oral route. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c5c8dc9-6478-4d8e-8fcb-5c9d1c230b25/documents/IUC5-d32e6216-70f2-42de-806d-09d547d5c249_7afb6021-be15-44fb-9263-ceb6a91a4aa1.html,,,,,, Dibutyltin maleate,78-04-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c5c8dc9-6478-4d8e-8fcb-5c9d1c230b25/documents/IUC5-d32e6216-70f2-42de-806d-09d547d5c249_7afb6021-be15-44fb-9263-ceb6a91a4aa1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.3 mg/kg bw/day,,rat Dibutyltin maleate,78-04-6,"The following studies have been submitted to address the acute toxicity: oral endpoint:Sarasin G (1982). TK 10422: ACUTE ORAL LD50 IN THE RAT. Testing laboratory: Ciba Geigy Ltd., Basle, Switzerland, GU2 Toxicology. Report no.: 811808. Owner company: Crompton GmbH. Report date: 1982-02-02.Schafer EW & Bowles WA (1985). Acute Oral Toxicity and Repellency of 933 Chemicals to House and Deer Mice. Arch. Environ. Contam. Toxicol, 14: 111-129.Sarasin (1982) was allocated a Klimisch score of 2 because the highest dose level (2500 mg/kg bw) exceeded the limit dose (2000 mg/kg bw) in rats and the source and purity of the test material was not reported. Schafer and Bowles (1985) contains insufficient information for assessment and is allocated a Klimisch score of 4. Sarasin (1982) is considered to be the key study for this endpoint.The following study has been submitted to address the acute toxicity: inhalation endpoint:Bretz R (1982). Report on acute aerosol inhalation toxicity in the rat of TK-10422. Testing laboratory: Ciba Geigy Ltd., Basle, Switzerland, GU2 Toxicology. Report no.: 81-1811. Owner company: Crompton GmbH. Report date: 1982-02-26.The study was allocated a Klimisch score of 2 because it is considered to be comparable to a guideline study but the source and purity of the test material were not reported. The study is considered to be the key study for this endpoint.The following study has been submitted to address the acute toxicity: dermal endpoint:Sanders A (2010a). Title: CAS No 78-04-6: ACUTE DERMAL TOXICITY (LIMIT TEST) IN THE RAT. Testing Laboratory: Harlan Laboratories Ltd, Shardlow Business, London Road, Shardlow, Derbyshire, DE72 2GD, UK. Report No 4100/3380. Owner Company: Organo Tin REACH Consortium, c/o ReachCentrum, Avenue E. Van Nieuwenhuyse 6, B-1160 Brussels, BELGIUMThe study was conducted to GLP and in line with a recognised guideline (OECD 402)and has been allocated a Klimisch score of 1. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c5c8dc9-6478-4d8e-8fcb-5c9d1c230b25/documents/IUC5-d4784100-6c4c-4b18-938b-7a286caf502e_7afb6021-be15-44fb-9263-ceb6a91a4aa1.html,,,,,, Dibutyltin maleate,78-04-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c5c8dc9-6478-4d8e-8fcb-5c9d1c230b25/documents/IUC5-d4784100-6c4c-4b18-938b-7a286caf502e_7afb6021-be15-44fb-9263-ceb6a91a4aa1.html,,oral,LD50,510 mg/kg bw,, Dibutyltin maleate,78-04-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c5c8dc9-6478-4d8e-8fcb-5c9d1c230b25/documents/IUC5-d4784100-6c4c-4b18-938b-7a286caf502e_7afb6021-be15-44fb-9263-ceb6a91a4aa1.html,,dermal,discriminating dose,"2,000 mg/kg bw",, Dibutyltin maleate,78-04-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c5c8dc9-6478-4d8e-8fcb-5c9d1c230b25/documents/IUC5-d4784100-6c4c-4b18-938b-7a286caf502e_7afb6021-be15-44fb-9263-ceb6a91a4aa1.html,,inhalation,LC50,317 mg/m3,, Dibutyltin oxide,818-08-6,"The following key study on the registered substance DBTO has been submitted to address repeated-dose toxicity: Morley, 2024: OECD TG 422, rat, 0.75, 3 or 5 mg DBTO/kg/day by oral gavage, NOAEL for systemic toxicity =3 mg/kg/day. Two females receiving 5 mg/kg/day were in bad health condition and thus euthanized for welfare reasons. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a833d34-44dd-4be1-9e85-9a2b4cc3e43e/documents/04b2c1ae-0fe6-4d7a-8365-b8cd4b8afb0f_203463ab-9465-4023-9597-7b468018bdd1.html,,,,,, Dibutyltin oxide,818-08-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a833d34-44dd-4be1-9e85-9a2b4cc3e43e/documents/04b2c1ae-0fe6-4d7a-8365-b8cd4b8afb0f_203463ab-9465-4023-9597-7b468018bdd1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,3 mg/kg bw/day,,rat Dibutyltin oxide,818-08-6," The following data were submitted to address the endpoint acute toxicity: ORAL Key Study: Bioneeds (2019) Amulya TS (2019) Acute Oral Toxicity Study of Dibutyltin Oxide, FASCAT® 4201 in Sprague Dawley Rats. Testing Laboratory: BIONEEDS INDIA PRIVATE LIMITED, DEVARAHOSAHALLY, SOMPURA HOBLI, NELAMANGALA TALUK, BANGALORE RURAL DISTRICT, PIN - 562 111, KARNATAKA, INDIA. Owner company: PMC ORGANOMETALLIX INC., 2316 HIGHLAND AVE CARROLLTON, KY 41008, USA. Project number: BIO-ATX 051. Report date: 2019-02-14.   Supporting Studies: Thevenaz, P.H. (1983). TK13019.  Acute Oral  LD50 in the Rat. Testing Laboratory: CIBA-GEIGY, Ltd., Sisseln facility, CH-4332 Stein, Switzerland. Owner company: Plastics and Additives Division, Ciba-Geigy Limited. Report No.: GU Project Number 821571. Report date: 1983-02-24 M&T Chemicals, Inc. (1977) Acute oral toxicity study in rats -  Thermolite 15, JCRDY-611K, 4201. Testing Laboratory: Bio/Dynamics, Inc., Toxicological Resources Unit. Owner company: M&T Chemicals, Inc. Company study No.: 4542-77. Report date: 1978-01-04. Schering AG, Experimentelle Toxikologie (1971) Systemische  Verträglichkeitsprüfung an Ratten bei einmaliger p.o. Verabreichung  (DL50). Owner company: Schering AG, Experimentelle Toxikologie. Company study No.: 1971-01-04. Klimmer, O.R. von. (1969) IN  Toxicological Data on Organotin Compounds.  Smith, P.J.  International  Tin Research Institute.  Publication 538. Auletta CS (1980) Acute Oral Toxicity Study in Rats. Testing Laboratory: Bio/dynamics Inc. Owner company: M&T Chemical Inc., Rahway, New Jersey, USA. Project number: 6056-79 Report date: 1980-06-30 Auletta CS (1980) Acute Oral Toxicity Study in Rats. Testing Laboratory: Bio/dynamics Inc. Owner company: M&T Chemical Inc., Rahway, New Jersey, USA. Project number: 6055-79. Report date: 1980-06-05 Ciba-Geigy Ltd. (1972) Acute oral LD50 of TK 11285 in the rat. Owner company: CIBA-GEIGY, Ltd. Company study No.: Project  No. Siss 2501. Report date: 1972-12-14. DERMAL A Sanders (2010) ACUTE DERMAL TOXICITY (LIMIT TEST) IN THE RAT. Testing laboratory: Harlan Laboratories Limited, Shardlow Business Park, Shardlow, Derbyshire, DE72 2GD, UK. Owner company: Organo Tin REACH Consortium, c/o ReachCentrum, Avenue E. Van Nieuwenhuyse 6, B-1160, Brussels, BELGIUM. Report No.: 3109/0060. INHALATION Omission of study (data waiver): An acute inhalation toxicity study does not need to be submitted as the most appropriate route of exposure is the dermal route.  Based on the current classification of the substance, further testing is likely to result in unnecessary animal suffering. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a833d34-44dd-4be1-9e85-9a2b4cc3e43e/documents/fd26ebed-979d-4adf-8bb7-0cc225e92afc_203463ab-9465-4023-9597-7b468018bdd1.html,,,,,, Dibutyltin oxide,818-08-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a833d34-44dd-4be1-9e85-9a2b4cc3e43e/documents/fd26ebed-979d-4adf-8bb7-0cc225e92afc_203463ab-9465-4023-9597-7b468018bdd1.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Dibutyltin oxide,818-08-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a833d34-44dd-4be1-9e85-9a2b4cc3e43e/documents/fd26ebed-979d-4adf-8bb7-0cc225e92afc_203463ab-9465-4023-9597-7b468018bdd1.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Dicarbonyl(pentane-2,4-dionato-O,O')rhodium",14874-82-9,"The acute oral LD50 of rhodium dicarbonyl acetylacetonate was determined to be in the range of 50-500 mg/kg bw (Middleton and Husband, 1978). In a limit test, the acute dermal LD50 of acetylacetonatodicarbonyl rhodium (I) was found to exceed 2000 mg/kg bw (Collier, 1981).No relevant acute inhalation toxicity data were identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76d64a89-3099-41b4-9ce9-61aa0d132072/documents/IUC5-9d2f78e5-730d-44b5-b84f-d9a10a4c6f79_18d37980-5b89-49a3-a0f3-ba48cb613660.html,,,,,, "Dicarbonyl(pentane-2,4-dionato-O,O')rhodium",14874-82-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76d64a89-3099-41b4-9ce9-61aa0d132072/documents/IUC5-9d2f78e5-730d-44b5-b84f-d9a10a4c6f79_18d37980-5b89-49a3-a0f3-ba48cb613660.html,,oral,LD50,50 mg/kg bw,adverse effect observed, "Dicarbonyl(pentane-2,4-dionato-O,O')rhodium",14874-82-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76d64a89-3099-41b4-9ce9-61aa0d132072/documents/IUC5-9d2f78e5-730d-44b5-b84f-d9a10a4c6f79_18d37980-5b89-49a3-a0f3-ba48cb613660.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dicerium tricarbonate,537-01-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ef467e5-eccf-4cea-9a22-e33af75dfdff/documents/IUC5-12516780-d8f7-4ed5-ac06-c2298f17df00_06fe22a3-4f62-4e1b-a04d-834fe0c1860e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat Dicerium tricarbonate,537-01-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ef467e5-eccf-4cea-9a22-e33af75dfdff/documents/IUC5-12516780-d8f7-4ed5-ac06-c2298f17df00_06fe22a3-4f62-4e1b-a04d-834fe0c1860e.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,50.5 mg/m3,,rat Dicerium tricarbonate,537-01-9,"Oral: In the only available (and reliable study), the LD50 was determined to be > 5000 mg/kg bw.Dermal: In the only available (and reliable study), the LD50 was determined to be > 2000 mg/kg bw.Therefore, the test substance has practically no acute toxicity.Inhalation:According to the annex VIII paragraph 8.5. coulmn 2, this test can be waived. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ef467e5-eccf-4cea-9a22-e33af75dfdff/documents/IUC5-d4bf2b04-502e-47b5-9fee-dc934ef4ff5d_06fe22a3-4f62-4e1b-a04d-834fe0c1860e.html,,,,,, Dicerium tricarbonate,537-01-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ef467e5-eccf-4cea-9a22-e33af75dfdff/documents/IUC5-d4bf2b04-502e-47b5-9fee-dc934ef4ff5d_06fe22a3-4f62-4e1b-a04d-834fe0c1860e.html,,oral,LD50,"5,000 mg/kg bw",, Dicerium tricarbonate,537-01-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ef467e5-eccf-4cea-9a22-e33af75dfdff/documents/IUC5-d4bf2b04-502e-47b5-9fee-dc934ef4ff5d_06fe22a3-4f62-4e1b-a04d-834fe0c1860e.html,,dermal,LD50,"2,000 mg/kg bw",, Dicerium trisulphide,12014-93-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d27c7b6-3f45-46bc-a44f-d50240fc0c10/documents/15a52605-de21-4c9f-b81a-054628f5516f_6a6fed68-64ad-4904-b924-8d2d9ad7a001.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Dichlobenil,1194-65-6, ORAL The NOEL was determined to be 1 mg/kg bw/day according to a 4 week dog study performed in line with OECD Guideline 410 and EPA Guideline 82-1. The NOEL was determined to be 41 mg/kg bw/day according to a 13 week hamster study performed in line with OECD Guideline 410 and EPA Guideline 82-1. The NOEL was determined to be 25 mg/kg bw/day according to a 13 week mice study performed in line with OECD Guideline 410 and EPA Guideline 82-1. The NOEL was determined to be 1 mg/kg bw/day according to a 52 week dog study performed in line with OECD Guideline 410 and EPA Guideline 83-1. DERMAL The NOAEL was determined to be 1000 mg/kg bw/day according to a study performed in line with OECD Guideline 410 and EPA Guideline 82-2. INHALATION The NOAEC was determined to be 12 mg/m^3 according to a study performed in line with EU Method B.8. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b754d81-b107-4769-ba70-2b21222209c0/documents/IUC5-3a006563-6051-42b2-8a1b-1427f050a76c_357049a6-4e14-4ead-86a1-2c9d772956b4.html,,,,,, Dichlobenil,1194-65-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b754d81-b107-4769-ba70-2b21222209c0/documents/IUC5-3a006563-6051-42b2-8a1b-1427f050a76c_357049a6-4e14-4ead-86a1-2c9d772956b4.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rabbit Dichlobenil,1194-65-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b754d81-b107-4769-ba70-2b21222209c0/documents/IUC5-3a006563-6051-42b2-8a1b-1427f050a76c_357049a6-4e14-4ead-86a1-2c9d772956b4.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,12 mg/m3,,rat Dichlobenil,1194-65-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b754d81-b107-4769-ba70-2b21222209c0/documents/IUC5-3a006563-6051-42b2-8a1b-1427f050a76c_357049a6-4e14-4ead-86a1-2c9d772956b4.html,Chronic toxicity – systemic effects,oral,NOAEL,1 mg/kg bw/day,,dog Dichlobenil,1194-65-6," ORAL The LD50 for the test material was determined to be >2000 mg/kg bw according to a study performed in line with EPA OPPTS 870.1100. DERMAL The LD50 for the test material was determined to be >2000 mg/kg bw according to a study performed in line with OECD Guideline 402, EU Method B.3 and EPA FIFRA 81-2. INHALATION The LC50 for the test material was determined to be >250 mg/m³ (maximum attainable concentration) according to a study performed in line with EPA Guideline OPP 81-3 and in part with EU Method B.2. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b754d81-b107-4769-ba70-2b21222209c0/documents/IUC5-c3ef86c4-4f6e-475c-865b-5963133c9f16_357049a6-4e14-4ead-86a1-2c9d772956b4.html,,,,,, Dichlobenil,1194-65-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b754d81-b107-4769-ba70-2b21222209c0/documents/IUC5-c3ef86c4-4f6e-475c-865b-5963133c9f16_357049a6-4e14-4ead-86a1-2c9d772956b4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dichlobenil,1194-65-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b754d81-b107-4769-ba70-2b21222209c0/documents/IUC5-c3ef86c4-4f6e-475c-865b-5963133c9f16_357049a6-4e14-4ead-86a1-2c9d772956b4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dichlobenil,1194-65-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b754d81-b107-4769-ba70-2b21222209c0/documents/IUC5-c3ef86c4-4f6e-475c-865b-5963133c9f16_357049a6-4e14-4ead-86a1-2c9d772956b4.html,,inhalation,LC50,250 mg/m3,no adverse effect observed, Dichlone,117-80-6," The irritating potential of dichlone caused local effects in the stomach such as ulceration, mucosal roughening and wall thickening. In addition, the kidneys were identified as target organs as indicated by increased organ weights with no histopathological correlation in males. The vacuolization of the tubular epithelium observed in a high dose female was also seen in a control group female, therefore this effect is of questionable relevance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad7df5d5-36f9-4d8c-a495-554e58794146/documents/68e6de43-12ac-4dee-a0d6-dfaad6079e12_e76e90de-051c-4d71-8726-c4fa08023b0f.html,,,,,, Dichlone,117-80-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad7df5d5-36f9-4d8c-a495-554e58794146/documents/68e6de43-12ac-4dee-a0d6-dfaad6079e12_e76e90de-051c-4d71-8726-c4fa08023b0f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,0.5 mg/kg bw/day,,rat Dichlone,117-80-6," The substance is classified for acute oral toxicity based on LD50 values ranging from 160 to 1300 mg/kg. Acute dermal toxicity, OECD 402, GLP: LD50 (rat) > 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad7df5d5-36f9-4d8c-a495-554e58794146/documents/4f933aea-ad68-4b74-8e43-9f979691ad91_e76e90de-051c-4d71-8726-c4fa08023b0f.html,,,,,, Dichlone,117-80-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad7df5d5-36f9-4d8c-a495-554e58794146/documents/4f933aea-ad68-4b74-8e43-9f979691ad91_e76e90de-051c-4d71-8726-c4fa08023b0f.html,,oral,LD50,160 mg/kg bw,adverse effect observed, Dichlone,117-80-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad7df5d5-36f9-4d8c-a495-554e58794146/documents/4f933aea-ad68-4b74-8e43-9f979691ad91_e76e90de-051c-4d71-8726-c4fa08023b0f.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, Dichloride titanium oxide,13780-39-7,"Studies on repeated dose toxicity need not to be conducted as target chemical titanium oxychloride is an unstable intermediate resulting from the hydrolysis of parent compound titanium tetrachloride. Repeated dose toxicity studies on the final hydrolysis product titanium dioxide reveal that the substance needs not to be classified for repeated dose toxicity. Concerning the other final hydrolysis product hydrochloric acid, its corrosiveness is not of relevance in this case, as the target substance titanium oxychloride already is being classified as corrosive as well. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56526deb-b52d-4755-ac07-d6825779dea4/documents/IUC5-5c7988bf-73a2-4fab-99f3-a0a31cc86e44_ea7c4d84-d5c9-4121-8c05-215d09e84975.html,,,,,, Dichloride titanium oxide,13780-39-7,No studies on acute toxicity have to be conducted as the substance is classified as corrosive. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56526deb-b52d-4755-ac07-d6825779dea4/documents/IUC5-2eee9297-2ab1-4b15-bc0f-954bc1061afa_ea7c4d84-d5c9-4121-8c05-215d09e84975.html,,,,,, Dichloro(3-chloropropyl)methylsilane,7787-93-1," There are no repeated dose oral, inhalation or dermal studies available for dichloro(3-chloropropyl)methylsilane. Data waivers are in place for oral and dermal repeated dose toxicity endpoints. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16c462cc-69ce-451d-bc48-b9e82408ed61/documents/c0a9e9db-e9aa-4973-9619-4507fffe8f34_a91c1b59-8df9-498d-99fc-507aac46e56e.html,,,,,, Dichloro(3-chloropropyl)methylsilane,7787-93-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16c462cc-69ce-451d-bc48-b9e82408ed61/documents/c0a9e9db-e9aa-4973-9619-4507fffe8f34_a91c1b59-8df9-498d-99fc-507aac46e56e.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 mg/m3,adverse effect observed,rat Dichloro(3-chloropropyl)methylsilane,7787-93-1," The key acute oral study is an Acute Toxic Class study with GLP reporting an LD50 value in the range 25-200 mg/kg bw (Huls AG, 1997). There are no data for the inhalation and dermal routes and the corrosive nature of dichloro(3-chloropropyl)methylsilane means that acute studies via these routes (required in Section 8.5.2 and 8.5.3, Annex VIII) do not need to be conducted. The selected study is the worst-case assessment of acute oral toxicity based on studies with the registered substance. The test was conducted in accordance with an appropriate OECD test guideline and in compliance with GLP. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16c462cc-69ce-451d-bc48-b9e82408ed61/documents/cb00a215-d67a-4d55-accd-1105caebb22e_a91c1b59-8df9-498d-99fc-507aac46e56e.html,,,,,, Dichloro(3-chloropropyl)methylsilane,7787-93-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16c462cc-69ce-451d-bc48-b9e82408ed61/documents/cb00a215-d67a-4d55-accd-1105caebb22e_a91c1b59-8df9-498d-99fc-507aac46e56e.html,,oral,LD50,25 mg/kg bw,adverse effect observed, Dichloro(diphenyl)silane,80-10-4,"RDT oral (OECD TG 408), rat: NOAEL local = 40 mg/kg bw/day, NOAEL systemic = 40 mg/kg bw/day   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6baccf0a-ed5a-4419-a8c5-49b88bae1af7/documents/afe8da45-7a25-4962-b103-0f601be9ae53_868b43f0-a915-4050-bd84-eed0463426c6.html,,,,,, Dichloro(diphenyl)silane,80-10-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6baccf0a-ed5a-4419-a8c5-49b88bae1af7/documents/afe8da45-7a25-4962-b103-0f601be9ae53_868b43f0-a915-4050-bd84-eed0463426c6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat Dichloro(diphenyl)silane,80-10-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6baccf0a-ed5a-4419-a8c5-49b88bae1af7/documents/afe8da45-7a25-4962-b103-0f601be9ae53_868b43f0-a915-4050-bd84-eed0463426c6.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 mg/m3,adverse effect observed,rat Dichloro(diphenyl)silane,80-10-4,"There is no reliable acute toxicity data. However, in accordance with Column 2 of REACH Annexes VII and VIII, acute toxicity studies (required in Section 8.5) do not need to be conducted as the substance is classified as corrosive to skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6baccf0a-ed5a-4419-a8c5-49b88bae1af7/documents/79ed1c49-5dd8-4099-a4cd-48cd1205e7d1_868b43f0-a915-4050-bd84-eed0463426c6.html,,,,,, Dichloro(methyl)(phenyl)silane,149-74-6,"Subchronic repeated dose data are not available for dichloro(methyl)(phenyl)silane (CAS 149-74-6, EC 205-746-2). As a result, the key data for the similar chlorosilane dichloro(diphenyl)silane (CAS 80-10-4, EC 201-251-0) and non-silanol hydrolysis product hydrogen chloride (HCl) (CAS 7647-01-0, EC 231-595-7) are read across to the registered substance.   The OECD Test Guideline 408 and GLP-compliant study with dichloro(diphenyl)silane is identified as key (BSL Bioservice Scientific Laboratories, 2021a, reliability 1). In this study, the No Observed Adverse Effect Level (NOAEL) for systemic effects in the rat was 40 mg/kg bw/day based on liver histopathology at the highest dose of 125 mg/kg bw/day. The NOAEL for local effects in the forestomach was also identified as 40 mg/kg bw/day.   In the key inhalation study with the HCl, conducted in a manner similar to OECD Test Guideline 413 and in compliance with GLP (Toxigenics Inc., 1984, reliability 2), the No Observed Adverse Effect Concentration (NOAEC) for local effects was not established since irritant / corrosive effects were observed at all concentrations tested. The NOAEC for systemic effects was determined to be 20 ppm gas (nominal) in rats and mice based on lower body weight following exposure to 50 ppm gas (nominal, considered secondary to the local effects). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c2404e7-c49a-4abf-82ef-c17b0fb7e5ce/documents/27f347a8-127a-4f73-a742-dff6c744cebe_430cbf7f-b736-40dd-ae33-16060e16ade6.html,,,,,, Dichloro(methyl)(phenyl)silane,149-74-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c2404e7-c49a-4abf-82ef-c17b0fb7e5ce/documents/27f347a8-127a-4f73-a742-dff6c744cebe_430cbf7f-b736-40dd-ae33-16060e16ade6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat Dichloro(methyl)(phenyl)silane,149-74-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c2404e7-c49a-4abf-82ef-c17b0fb7e5ce/documents/27f347a8-127a-4f73-a742-dff6c744cebe_430cbf7f-b736-40dd-ae33-16060e16ade6.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,20 ,, Dichloro(methyl)(phenyl)silane,149-74-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c2404e7-c49a-4abf-82ef-c17b0fb7e5ce/documents/27f347a8-127a-4f73-a742-dff6c744cebe_430cbf7f-b736-40dd-ae33-16060e16ade6.html,Repeated dose toxicity – local effects,inhalation,NOAEC,< 10 ,adverse effect observed, Dichloro(methyl)(phenyl)silane,149-74-6,"Oral   In the key acute oral toxicity study with dichloro(methyl)(phenyl)silane (CAS RN 149-74-6, EC 205-746-2), conducted according to OECD Test Guideline 423 and in compliance with GLP, the oral LD50 for both sexes combined was determined to be >200 to <2000 mg/kg bw (Laboratory of Pharmacology and Toxicology, 2002, reliability 2).   Dermal / Inhalation   In accordance with Column 2 of REACH Annex VIII (Section 8.5), acute toxicity studies by the inhalation or dermal routes do not need to be conducted since the registered substance is classified as corrosive to the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c2404e7-c49a-4abf-82ef-c17b0fb7e5ce/documents/6af3b6c1-312d-49bc-ae91-c0e1b6d7fbd7_430cbf7f-b736-40dd-ae33-16060e16ade6.html,,,,,, Dichloro(methyl)(phenyl)silane,149-74-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c2404e7-c49a-4abf-82ef-c17b0fb7e5ce/documents/6af3b6c1-312d-49bc-ae91-c0e1b6d7fbd7_430cbf7f-b736-40dd-ae33-16060e16ade6.html,,oral,LD50,> 200 mg/kg bw,adverse effect observed, Dichloro(methyl)(vinyl)silane,124-70-9,"There are no repeated dose toxicity data on dichloro(methyl)(vinyl)silane or its hydrolysis product, methyl(vinyl)silanediol, so good quality data for the related substance trimethoxyvinylsilane have been used to assess the general systemic toxicity of dichloro(methyl)(vinyl)silane.In an oral OECD 422 study ( Hashima Labs, no date) in rats, trimethoxyvinylsilane was administered by gavage at doses up to 1000 mg/kg bw/day, for approximately 28 days. The LOAEL was 62.5 mg/kg bw/day (based on decreased relative thymus weight in females and histopathological changes in the urinary bladder of males) and the NOAEL was < 62.5 mg/kg bw/day for both sexes.In a 14-week whole-body inhalation study (BRRC, 1990) in which rats were exposed to trimethoxy(vinyl)silane at concentrations up to 400 ppm, a concentration of 100 ppm was a LOAEC (effects included decreased urine osmolality and sodium, potassium and chloride concentrations in males and slight decrease in body weight and body weight gain in females), and 10 ppm (58 mg/m3) was a NOAEC. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48e81af8-12c6-4957-b8fc-b5863610bde5/documents/IUC5-a21d82c8-014d-4dc2-8766-2e27d9853370_51917ac1-7e5b-4192-a4e0-ff726605055c.html,,,,,, Dichloro(methyl)(vinyl)silane,124-70-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48e81af8-12c6-4957-b8fc-b5863610bde5/documents/IUC5-a21d82c8-014d-4dc2-8766-2e27d9853370_51917ac1-7e5b-4192-a4e0-ff726605055c.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,62.5 mg/kg bw/day,,rat Dichloro(methyl)(vinyl)silane,124-70-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48e81af8-12c6-4957-b8fc-b5863610bde5/documents/IUC5-a21d82c8-014d-4dc2-8766-2e27d9853370_51917ac1-7e5b-4192-a4e0-ff726605055c.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,58 mg/m3,,rat Dichloro(methyl)(vinyl)silane,124-70-9,"The key acute oral study was conducted according to OECD 423 (Acute Toxic Class method), giving an LD50 for male and female rats in the range 200 - 2000 mg/kg bw when dosed in dehydrated olive oil (NOTOX, 2003). Clinical signs observed included hunched and flat posture, piloerection, salivation, lethargy, clonic spasms, uncoordinated movements, slow breathing, and ptosis. The key acute inhalation study was conducted according to OECD 402, giving an LC50 of approx. 2021 ppm for one-hour, whole-body exposure (DCC, 2002), (equivalent to a 4-hour LC50 of 1010 ppm (approx. 5.9 mg/l). Longer exposure times were not used due to the corrosivity of the test substance. Clinical signs and necropsy findings for animals that died during the study reflected the corrosive nature of the test substance.No acute dermal data are available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48e81af8-12c6-4957-b8fc-b5863610bde5/documents/IUC5-4f67e499-96ba-46c9-ab7c-0a43719be94c_51917ac1-7e5b-4192-a4e0-ff726605055c.html,,,,,, Dichloro(methyl)silane,75-54-7,"The are no data regarding the repeated dose toxicity of dichloro(methyl)silane, therefore data from a substance structurally-related to the hydrolysis product (dimethylsilanediol, DMSD, CAS 1066-42-8) have been used to read-across. In this OECD 422 study (Dow Corning Corporation, 2009), Sprague-Dawley rats in the toxicity phase of the study were dosed for 28/29 days. The NOAEL was based on hepatic protoporphyrinosis in males at the higher dose of 500 mg/kg bw/day. As has been demonstrated by the acute toxicity and irritation/corrosion data, there would also be corrosive local effects from HCl if dichloro(methyl)silane were to be administered. There are no reliable repeated dose toxicity data for the dermal and inhalation routes. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7cd2db40-a282-4e92-a2e5-e67926812213/documents/IUC5-1290123d-51c6-4e43-9bed-77533d1ef51a_2fbc8d36-cc4f-4ac9-a3a3-05c720e9140d.html,,,,,, Dichloro(methyl)silane,75-54-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7cd2db40-a282-4e92-a2e5-e67926812213/documents/IUC5-1290123d-51c6-4e43-9bed-77533d1ef51a_2fbc8d36-cc4f-4ac9-a3a3-05c720e9140d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,, Dichloro(methyl)silane,75-54-7,"The key oral LD50 value (0.28 mg/kg based on density of 1.105) is derived from a gavage study (BRRC, 1981) in Wistar rats comparable to the now deleted OECD 401. Sluggishness was the main clinical sign of toxicty, but there were also some instances of dyspnea, unsteady gait and prostration. Gross necropsy mainly revealed discoloured, fluid-filled and/or enlarged organs (liver, spleen, intestines, stomach, kidneys). The key inhalation LD50 value is derived from a whole body one-hour vapour inhalation study (DCC, 2001) in Fischer 344 rats comparable to OECD 403. The principal clinical signs were indicative of respiratory and ocular effects: labored breathing, gasping and rales, ocular opacity that progressed to more severe ocular damage well into the observation period, salivation, green staining of various body surfaces, dried material around the eyes nose and/or mouth, lacrimation, hypoactivity, red and swollen paws and nasal discharge. The most common necropsy finding in this study was ocular damage. There are no acute dermal data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cd2db40-a282-4e92-a2e5-e67926812213/documents/IUC5-fb13170e-e64e-44fd-b1a5-3bcf5d6d5238_2fbc8d36-cc4f-4ac9-a3a3-05c720e9140d.html,,,,,, Dichloro(methyl)silane,75-54-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cd2db40-a282-4e92-a2e5-e67926812213/documents/IUC5-fb13170e-e64e-44fd-b1a5-3bcf5d6d5238_2fbc8d36-cc4f-4ac9-a3a3-05c720e9140d.html,,oral,LD50,280 mg/kg bw,, Dichloro(methyl)silane,75-54-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cd2db40-a282-4e92-a2e5-e67926812213/documents/IUC5-fb13170e-e64e-44fd-b1a5-3bcf5d6d5238_2fbc8d36-cc4f-4ac9-a3a3-05c720e9140d.html,,inhalation,LC50,"8,397.9 mg/m3",, Dichloro(phenyl)phosphine,644-97-3,"The hydrolysis product CAS 1779-48-2 was of low toxicity in a repeated dose feeding study in rats (NOEL – 10,000 ppm in rat diet for 28 days (779 mg/kg for males and 859 mg/kg for females) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb902eb7-0143-4dc4-81f6-f1ae2a861c8d/documents/IUC5-4d3af8dd-6906-4344-b7a2-f2b619b5659b_3a15c296-29fa-46bb-8391-54f115e5c91a.html,,,,,, Dichloro(phenyl)phosphine,644-97-3,"The information on acute toxicity is limited. The substance is highly reactive and releases hydrochloric acid upon contact with water. As such, it is corrosive and the secondary information on an LD50 between 500 and 2000 mg/kg bw plausible. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb902eb7-0143-4dc4-81f6-f1ae2a861c8d/documents/IUC5-0597515a-3ff8-4f6f-991c-79c897561ed7_3a15c296-29fa-46bb-8391-54f115e5c91a.html,,,,,, Dichloroacetic acid,79-43-6," A key 90-day toxicity study in dogs was selected based on lowest LOAEL (12.5 mg/kg-day) for various target organs (metabolism, hepatic, neurologic, reproductive). Adverse effects noted at the low-dose group included mild to severe testicular degeneration, along with mild to moderate hepatic vacuolization and mild vacuolization of the myelinated white tracts of the cerebrum and cerebellum in males and females. Data from humans administered DCA as a pharmaceutical indicate that doses of 25-50 mg/kg-day produce neurological effects, including sedation and peripheral neuropathy. Data from supporting studies confirmed the target organs for hazard in rats and dogs, and in addition data from mechanistic studies indicated peroxisome proliferation and induction of carnitine acetyl-transferase, palmityl-CoA oxidase and the PPA-protein in the liver of rats and mice. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6993fc9a-fa4b-4446-8a32-a1e685384e2a/documents/204fc0b8-073c-4245-b94b-b6e5da28a7f8_fc55ccb5-aae0-4525-b4ea-78c35c1ab43e.html,,,,,, Dichloroacetic acid,79-43-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6993fc9a-fa4b-4446-8a32-a1e685384e2a/documents/204fc0b8-073c-4245-b94b-b6e5da28a7f8_fc55ccb5-aae0-4525-b4ea-78c35c1ab43e.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,12.5 mg/kg bw/day,,dog Dichloroacetic acid,79-43-6,"Various acute oral toxicity studies with dichloroacetic acid  were available in rats and mice, with LD50 values ranging between 2820 and 5520 mg/kg bw; therefore the substance does not have to be classified for acute oral toxicity. Acute inhalation toxicity testing was waived based on a very low vapor pressure. Finally acute dermal toxicity  was tested in rabbits, resulting in LD50 of 0.51 mL/kg bw, corresponding with 797 mg/kg bw. Classification for acute dermal toxicity is therefore warranted. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6993fc9a-fa4b-4446-8a32-a1e685384e2a/documents/a8ddaf05-c524-433b-823d-e11fcbc54542_fc55ccb5-aae0-4525-b4ea-78c35c1ab43e.html,,,,,, Dichloroacetic acid,79-43-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6993fc9a-fa4b-4446-8a32-a1e685384e2a/documents/a8ddaf05-c524-433b-823d-e11fcbc54542_fc55ccb5-aae0-4525-b4ea-78c35c1ab43e.html,,oral,LD50,"2,820 mg/kg bw",no adverse effect observed, Dichloroacetic acid,79-43-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6993fc9a-fa4b-4446-8a32-a1e685384e2a/documents/a8ddaf05-c524-433b-823d-e11fcbc54542_fc55ccb5-aae0-4525-b4ea-78c35c1ab43e.html,,dermal,LD50,797 mg/kg bw,adverse effect observed, Dichloroacetyl chloride,79-36-7,Publications providing data on oral and inhalation routes of exposure: the substance did not show any toxic effects under the conditions of the studies reported in the publications. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7221c65d-f42c-494f-bca2-d4e753362234/documents/IUC5-58f55529-2f1d-44ea-b3c9-2093951e7ab0_977f786b-b872-4426-96b3-c246ef4f8e8c.html,,,,,, Dichloroacetyl chloride,79-36-7,"Data waiving: According to column 2 of REACH Annex VII and Annex VIII, the acute toxicity studies does not need to be conducted since the substance is classified as corrosive to the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7221c65d-f42c-494f-bca2-d4e753362234/documents/IUC5-65d0af36-03df-4cb5-84d4-76421d9eab5a_977f786b-b872-4426-96b3-c246ef4f8e8c.html,,,,,, Dichlorobis(η-cyclopentadienyl)titanium,1271-19-8,"The NTP performed a series of studies with the substance. In the 14 -day range finding study hyperplasia of the forestomach epithelium was already observed at the end of the study period. Erosion and ulcers were seen at the top dose of 500 mg/kg bw/d and were associated with acute inflammation and regenerative hyperplasia. In a 90-day oral gavage study. The doses were 8, 16, 31, 62 and 125 mg/kg bw/d. At the lowest dose epithelial hyperplasia and hyperkeratosis were seen in the forestomach. In the glandular stomach inflammation was observed. The LOAEL for local effects is therefore set at 8 mg/kg bw/d. At 125 mg/kg bw/d one mortality was observed. Significantly reduced body weight and related to the lower body weights absolute and relative organ weight changes were seen at 125 and 62 mg/kg bw/d. Therefore the NOAEL for systemic effects is 31 mg/kg bw/d. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/52ae3014-9535-4ab3-a5e7-da2c37ca0cc7/documents/48099f2d-fbd0-4030-ac9e-93f58bceceec_a608daf8-3ace-4811-8797-b8b331a9403b.html,,,,,, Dichlorobis(η-cyclopentadienyl)titanium,1271-19-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/52ae3014-9535-4ab3-a5e7-da2c37ca0cc7/documents/48099f2d-fbd0-4030-ac9e-93f58bceceec_a608daf8-3ace-4811-8797-b8b331a9403b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,31 mg/kg bw/day,,rat Dichlorobis(η-cyclopentadienyl)titanium,1271-19-8,"An acute oral study is not available for the substance. In an 14 -d DRF study all animals died by day 9, the first on day 5, of dosing at 1000 mg/kg bw/d (5 sex/dose). 1/5 males died and 3/5 females dies at 500 mg/kg bw/d the first by day 9 and the last by day 16, 4/10. None died at 250 mg/kg bw/d. Based on this information the substances is classified in CLP Category 4.   Based on the granulomertry an acute inhalation study is not required. In case of exposure the particles will end up in the upper airways and will be swallowed.   An acute dermal study is available. No mortality, systemic effect or effects on the skin were observed. The LD50 is > 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52ae3014-9535-4ab3-a5e7-da2c37ca0cc7/documents/5cf6866b-2e70-4a4f-a6e9-224dbbca7ee8_a608daf8-3ace-4811-8797-b8b331a9403b.html,,,,,, Dichlorocyclohexylmethylsilane,5578-42-7," There are no repeated dose oral, inhalation or dermal studies available for dichloro(cyclohexyl)methylsilane. Data waivers are in place for oral and dermal repeated dose toxicity endpoints (see attachment to data waiver for repeated dose toxicity: oral). A 14-day non-GLP dose range-finding study was conducted based on guideline OECD 407 but modified to realise a staggered dose selection depending on substance related effects. Additional histopathology examinations were performed for precisely NOEAL justification, but a NOAEL could not be determined (Bioservice, 2019). In the study test item-related gross lesions were noted in the gastrointestinal organs at ≥ 175 mg/kg bw/day and these were evident during histopathological examination. At the microscopic examination, specific findings were found, starting at the dose of 50 mg/kg bw/day. These findings included inflammatory and degenerative lesions which consisted of inflammation, erosions, hyperplasia, ulceration and epithelial degeneration. Trichloro(propyl)silane was tested in a 7-day dose range-finding study (non-GLP; Bioservice, 2018) in order to determine appropriate doses (to avoid corrosive effects) for administration in repeated dose toxicity tests. In this study a NOAEL could not be determined due to the corrosive effects of the test substance on the gastrointestinal and respiratory tracts. All animals administered the tests substance were sacrificed on study day 2 due to ethic reasons. The findings at pathology and histopathology showed signs of corrosion which was considered to be related to the hydrolysis product hydrochloric acid.  Since the local corrosive effects of chlorosilanes are significant, valid oral or inhalation studies according to the relevant guidelines are technically not feasible. It is also unlikely that any systemic effects would be observed at doses made sufficiently low to prevent the known corrosive effects and/or distress in the test species. Indeed, ECHA’s Executive Director made the following statement in his decision (No. ED/49/2015) for trichlorosilane “ECHA notes that the Contested Decision should not have provided the option of carrying out the PNDT study on the registered substance, which is corrosive and consequently can only be tested at very low concentrations. In a PNDT study, which normally requires high systematic availability of the tested substance, the very low concentrations would almost certainly lead to a negative result”.   To support this conclusion a 28-day inhalation study with another chlorosilane, dichloro(dimethyl)silane (CAS 75-78-5, WIL, 2014) is used to demonstrate that local effects are dominated by generation of the hydrolysis product, HCl, and that there are no adverse systemic effects.   In a well conducted 90-day gas inhalation study (Toxigenics, 1984) the systemic NOAEC for hydrogen chloride was 20 ppm based on decreased body weight following exposure to 50 ppm (6 hours/day, 5 days/week) in rats and mice. The main adverse findings related to irritant/corrosive effects on the nasal turbinates in mice, which was observed with a LOAEC of 10 ppm. A good quality 90-day repeated inhalation study for hydrogen chloride has been used to assess the local effects of trichloro(propyl)silane. In a 90-day repeated inhalation study with HCl, no serious adverse systemic effects were observed in rats and mice exposed up to 50 ppm (approximately 70 mg/m3) for 6 hours per day, 5 days per week. The only significant adverse finding relating to systemic toxicity was decreased body weight at the highest dose level. Local effects on the nasal turbinates of mice were observed at all dose levels tested (10, 20 and 50 ppm). Testing with HCl at higher test concentrations is neither ethically nor technically feasible since severe corrosive effects would lead to discomfort and distress in the test animals. The author of this CSR considers that the apparent systemic effects at 50 ppm in the study were most likely secondary to local corrosive effects at this dose level. Following uptake of HCl, hydrogen and chloride ions form will enter the body’s natural homeostatic processes and significant systemic effects are unlikely. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/affcb072-1f46-487f-9d9c-cce951a7242e/documents/dff18acb-ee72-46d1-88f8-0fa95eeaf94b_ecfae858-37cb-40af-9b58-f7228efd4de9.html,,,,,, Dichlorocyclohexylmethylsilane,5578-42-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/affcb072-1f46-487f-9d9c-cce951a7242e/documents/dff18acb-ee72-46d1-88f8-0fa95eeaf94b_ecfae858-37cb-40af-9b58-f7228efd4de9.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 mg/m3,adverse effect observed,rat Dichlorocyclohexylmethylsilane,5578-42-7," The key acute oral study (LPT, 2003), conducted with the registered substance, according to OECD TG 423 and in compliance with GLP, reported an LD50 in male and female rats greater than 2000 mg/kg bw when dosed in corn oil. No treatment-related effects were reported. In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5.2) does not need to be conducted as the substance is classified as corrosive. In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the dermal route (required in Section 8.5.3) does not need to be conducted as the substance is classified as corrosive. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/affcb072-1f46-487f-9d9c-cce951a7242e/documents/22363da5-c2c2-45bc-af45-fb9674e22019_ecfae858-37cb-40af-9b58-f7228efd4de9.html,,,,,, Dichlorocyclohexylmethylsilane,5578-42-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/affcb072-1f46-487f-9d9c-cce951a7242e/documents/22363da5-c2c2-45bc-af45-fb9674e22019_ecfae858-37cb-40af-9b58-f7228efd4de9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dichlorodifluoromethane,75-71-8," No adverse effects were observed in sub-chronic and chronic inhalation toxicity and carcinogenicity studies at relatively high concentrations. - 90-day inhalation, rat: NOAEC > 10000 ppm, 49350 mg/m3 - 2-year inhalation, rat: NOAEC: 5000 ppm, 24676 mg/m3 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88b0972a-3932-4fd7-b01a-8afb8a80d4c1/documents/IUC5-47e39f79-6007-4cc9-9128-79628a1ba830_eba0ca73-fc03-4a67-9ef2-169fc6f2dc6b.html,,,,,, Dichlorodifluoromethane,75-71-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88b0972a-3932-4fd7-b01a-8afb8a80d4c1/documents/IUC5-47e39f79-6007-4cc9-9128-79628a1ba830_eba0ca73-fc03-4a67-9ef2-169fc6f2dc6b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,>= 150 mg/kg bw/day,,rat Dichlorodifluoromethane,75-71-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88b0972a-3932-4fd7-b01a-8afb8a80d4c1/documents/IUC5-47e39f79-6007-4cc9-9128-79628a1ba830_eba0ca73-fc03-4a67-9ef2-169fc6f2dc6b.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"24,676 mg/m3",,rat Dichlorodifluoromethane,75-71-8,"Experimental data for acute Oral and inhalation toxicity, although not performed according to most current standards, showed a low acute toxicity at the highest achievable dose levels. Acute oral, rat, LD50 > 1000 mg/kg (maximum feasible dose, no mortality observed). Not an expected route of exposure. Acute dermal: no relevant (gaseous substance) Acute inhalation: various experimental results available with 30 min, 4h or 6h exposures, no mortality observed. Using the Haber's Law and a default n=1 for extrapolating to a longer exposure time the following converted value is obtained as a conservative estimate: rat, inhalation, eq. to 4h,  LC50: >100,000 ppm, eq. to > 493,510 mg/m3  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88b0972a-3932-4fd7-b01a-8afb8a80d4c1/documents/IUC5-0fe44259-49fe-407f-961d-194a25ec43ab_eba0ca73-fc03-4a67-9ef2-169fc6f2dc6b.html,,,,,, Dichlorodifluoromethane,75-71-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88b0972a-3932-4fd7-b01a-8afb8a80d4c1/documents/IUC5-0fe44259-49fe-407f-961d-194a25ec43ab_eba0ca73-fc03-4a67-9ef2-169fc6f2dc6b.html,,inhalation,LC50,"493,510 mg/m3",no adverse effect observed, Dichlorododecylmethylsilane,18407-07-3," There are no reliable acute toxicity data. However, in accordance with Column 2 of REACH Annexes VII and VIII, acute toxicity studies (required in Section 8.5) do not need to be conducted as the substance is classified as corrosive to skin. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96ed1730-f0cf-4fde-9b1b-cb7ea6945c32/documents/ce3adfcc-d6ff-4f1a-9444-f4d3e19d4f21_20a57078-75ea-42d9-a5c2-1494410f1cb3.html,,,,,, Dichloroisobutylaluminium,1888-87-5," Corrosive. Short chain aluminum alkyls ignite spontaneously on contact with air and therefore are classified pyrophoric. Reactions of aluminum alkyls with liquids are in some cases explosion like. Exposure of mammalian species to aluminum alkyls would not generate meaningful data, and no acute oral toxicity studies are required for this substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44faec90-b43a-49f9-ba92-b508878ca355/documents/IUC5-628ec79b-5cdb-417e-bf79-e4772bab6db0_6f2a8385-ce6a-4971-a29d-bd041072d359.html,,,,,, "Dichloromethyl(3,3,4,4,5,5,6,6,6-nonafluorohexyl)silane",38436-16-7,"Dichloromethyl(3,3,4,4,5,5,6,6,6-nonafluorohexyl)silane (EC No. 253-930-6, CAS 38436-16-7) has been tested for acute toxicity in accordance with now deleted OECD Test Guideline 401 and in compliance with GLP (Dow Corning Corporation, 1985; reliability score 2). From this study, the LD50 of 890 mg/kg bw was identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fe83506-7181-42fd-9bf8-eaad7350ee91/documents/130c1651-420e-4058-940f-40b308b04bec_cf1fa661-d6a3-4aa0-be74-2532be5af6f9.html,,,,,, "Dichloromethyl(3,3,4,4,5,5,6,6,6-nonafluorohexyl)silane",38436-16-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fe83506-7181-42fd-9bf8-eaad7350ee91/documents/130c1651-420e-4058-940f-40b308b04bec_cf1fa661-d6a3-4aa0-be74-2532be5af6f9.html,,oral,LD50,890 mg/kg bw,adverse effect observed, Dichloromethylbenzene,29797-40-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Comprehensive guideline studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c976987c-2933-4310-a453-3a02220dfe46/documents/IUC5-8ae600c6-2bd3-47da-b3c3-d8ee3001df1a_e034fc9a-afe6-427c-9b90-c6054d594fdc.html,,,,,, Dichloromethylbenzene,29797-40-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c976987c-2933-4310-a453-3a02220dfe46/documents/IUC5-8ae600c6-2bd3-47da-b3c3-d8ee3001df1a_e034fc9a-afe6-427c-9b90-c6054d594fdc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat Dichloromethylbenzene,29797-40-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c976987c-2933-4310-a453-3a02220dfe46/documents/IUC5-619a9178-de95-412d-80b6-c3dd367f81ac_e034fc9a-afe6-427c-9b90-c6054d594fdc.html,,oral,LD50,"2,344 mg/kg bw",no adverse effect observed, Dichloromethylbenzene,29797-40-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c976987c-2933-4310-a453-3a02220dfe46/documents/IUC5-619a9178-de95-412d-80b6-c3dd367f81ac_e034fc9a-afe6-427c-9b90-c6054d594fdc.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Dichloromethyltetradecylsilane,59086-80-5," There are no reliable acute toxicity data. However, in accordance with Column 2 of REACH Annexes VII and VIII, acute toxicity studies (required in Section 8.5) do not need to be conducted as the substance is classified as corrosive to skin. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2246d53d-c19d-4eb5-9695-20f9449cdf74/documents/45d3f74a-855d-43f3-b9a0-fb99006ecdbd_80fb0239-ab2e-4159-a1e7-2fb49438118d.html,,,,,, Dichlorosilane,4109-96-0," No data are available for the repeated dose oral toxicity of dichlorosilane, therefore good quality data for the precipitated hydrolysis product, synthetic amorphous silica (SAS), have been read-across to address the potential for systemic toxicity. In a repeat dose 90-day oral toxicity study (Kim et al., 2014) with Sprague-Dawley rats, two forms of synthetic amorphous silica (SAS and NM-202; differing in particle size and specific surface area) were administered (vehicle: water) by oral gavage for 90 consecutive days at a dose of 500, 1000 or 2000 mg/kg bw/day (10 animals/sex/group). The particles were described as either 20 or 100 nm in diameter. Extra animals were included in the control (received water only) and highest dose groups to allow for a two-week post-exposure recovery period. Observations were made according to OECD TG 408. For 20 and 100 nm silica samples the findings were sporadic and without a dose-response, so were concluded by the study authors not to be treatment-related. The NOAEL for both particle sizes was therefore concluded to be ≥2000 mg/kg bw/day. For local effects, a good quality study on hydrogen chloride is available. In a 90-day repeated dose inhalation study in rats and mice (Toxigenics, 1983), 31 males and 21 females of each species/strain were exposed to test concentrations of 0, 10, 20 and 50 ppm hydrogen chloride gas (HCl). Treatment was whole-body exposure for six hours per day, 5 days per week. The No Observed Adverse Effect Concentration (NOAEC) for systemic effects was determined to be 20 ppm (approximately 30 mg/m3) based on decreased body weight following exposure to 50 ppm. No NOAEC for local effects was established as irritant/corrosive effects were observed at all dose levels tested. No suitable dermal data are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c22e1dac-6f06-4f6d-b097-1a8b4d94a5d4/documents/a9195fdc-660f-4007-ada7-c1d8e9dc598b_57781c14-c7d5-4d16-9b0a-4870891ccdbf.html,,,,,, Dichlorosilane,4109-96-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c22e1dac-6f06-4f6d-b097-1a8b4d94a5d4/documents/a9195fdc-660f-4007-ada7-c1d8e9dc598b_57781c14-c7d5-4d16-9b0a-4870891ccdbf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,000 mg/kg bw/day",,rat Dichlorosilane,4109-96-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c22e1dac-6f06-4f6d-b097-1a8b4d94a5d4/documents/a9195fdc-660f-4007-ada7-c1d8e9dc598b_57781c14-c7d5-4d16-9b0a-4870891ccdbf.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 mg/m3,adverse effect observed,mouse Dichlorosilane,4109-96-0," The requirement for acute oral and dermal studies is waived on the basis that dichlorosilane is classified as corrosive. In an inhalation whole body exposure acute study with dichlorosilane, the LC50 after a 1-hour exposure period was calculated to be 314 ppm (1297 mg/m3), which equates to a 4-hour LC50 of 157 ppm (649 mg/m3). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c22e1dac-6f06-4f6d-b097-1a8b4d94a5d4/documents/9073a234-5fc7-417e-9d56-599f4c528d5d_57781c14-c7d5-4d16-9b0a-4870891ccdbf.html,,,,,, Dichlorosilane,4109-96-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c22e1dac-6f06-4f6d-b097-1a8b4d94a5d4/documents/9073a234-5fc7-417e-9d56-599f4c528d5d_57781c14-c7d5-4d16-9b0a-4870891ccdbf.html,,inhalation,LC50,649 mg/m3,adverse effect observed, "Dichlorotricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene, mixed isomers",28804-46-8," A 28-day repeated dose study by oral route in rats has been carried out in order to evaluate the toxicity of DPX-C after repeated exposure. Based on the findings of this study, it is concluded that the DPX-C (Di-Cloro-Di-p-Xililene) did not produce any toxicity or adverse effect at dose level 50 mg/kg b. wt./day when administered orally through gavage for 28 consecutive days, but it produces toxic effects at higher doses. Therefore, the No Observed Adverse Effect Level (NOAEL) of DPX-C (Di-Cloro-Di-p-Xililene) is 50 mg/kg b. wt./day. At higher doses effects on body weight and organ weights (kidney, liver, heart, brain, prostate, seminal vesicles, thyroid and parathyroid) were observed. Moreover, biochemical effects and effects on the produced urine were observed. There were histopathological lesions in kidneys and enlargement of liver associated with hypertrophy of hepatocyte (centriolobular and/or diffuse). In addition, follicular hypertrophy (thyroid) and hyaline droplets accumulation in cortical tubules in kidneys was observed. All dose groups showed minimal to mild severity of basophilic/ regenerating tubules in the cortex. However, some of the effects observed at the end of treatment were continued with reduced severity after recovery period. Other effects were almost completely recovered after ceasing the treatment. No studies by dermal and inhalation routes of exposure were performed, because exposure of humans via dermal / inhalation routes in production and or use is not likely as based on the provided thorough and rigorous exposure assessment . Therefore information by oral route was considered enough to sufficiently characterize the hazard of the substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f67a56d9-5b46-4fe4-8739-0ab52baeeaf9/documents/3d47e463-07be-4b49-8071-63e711f390f6_71e32cb1-dbab-45a4-8449-e45e2291419e.html,,,,,, "Dichlorotricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene, mixed isomers",28804-46-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f67a56d9-5b46-4fe4-8739-0ab52baeeaf9/documents/3d47e463-07be-4b49-8071-63e711f390f6_71e32cb1-dbab-45a4-8449-e45e2291419e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Dichlorotricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene, mixed isomers",28804-46-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Due to the nature of test item, it is not possible to conduct inhalation study. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f67a56d9-5b46-4fe4-8739-0ab52baeeaf9/documents/b6137703-1cee-4af6-8563-57a0b1bb2241_71e32cb1-dbab-45a4-8449-e45e2291419e.html,,,,,, "Dichlorotricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene, mixed isomers",28804-46-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f67a56d9-5b46-4fe4-8739-0ab52baeeaf9/documents/b6137703-1cee-4af6-8563-57a0b1bb2241_71e32cb1-dbab-45a4-8449-e45e2291419e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Dichlorotricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene, mixed isomers",28804-46-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f67a56d9-5b46-4fe4-8739-0ab52baeeaf9/documents/b6137703-1cee-4af6-8563-57a0b1bb2241_71e32cb1-dbab-45a4-8449-e45e2291419e.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, Dichromium nitride,12053-27-9," No repeated dose toxicity study with dichromium nitride is available. However, based on the information available from two chronic repeated dose oral toxicity studies conducted with chromium picolinate monohydrate using male and female F344/N rats and B6C3F1 mice, it was concluded using a read-across concept that dichromium nitride does not present a health hazard to either sex. No adverse effects could be observed after the administration of chromium picolinate monohydrate. The approach for read-across is described in detail in the document attached in IUCLID section 13. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a5f9310e-4e3f-4985-862f-9a2175f1b7fc/documents/5c9a411e-739b-4563-bfd5-2390da352f5d_9d24f340-686a-49f5-bce1-fd343e7505be.html,,,,,, Dichromium nitride,12053-27-9," Acute oral toxicity No acute oral toxicity studies with dichromium nitride are available, thus the acute toxicity will be addressed with existing data on chromium picolinate monohydrate using a category read-across concept.   Chromium picolinate monohydrate was administered in F344/N rats and B6C3F1 mice for 14 weeks in doses of up to 4240 mg/kg bw/day and 11900 mg/kg bw/day, respectively. This corresponds to a dose of 530 and 1488 mg Cr/kg bw/day.   Although this value is still below the acute toxicity limit dose of 2000 mg/kg bw/day, it nevertheless demonstrates that excessive doses of trivalent chromium do not exert any signs of mortality even over a sub-chronic exposure duration. Time extrapolation using modified Haber's law is applied for the effective dose obtained in a sub-chronic study in order to conclude on the information for acute oral toxicity (for adjustment from a longer exposure duration to a shorter exposure duration the modified Haber’s rule with a default value of “n” = 3 will be used to adjust the concentration, cf. ECHA guidance R.8, Appendix 8.8, which is generally thought to be a conservative approach). Based on this extrapolation, the acute oral toxicity of dichromium nitride is considered to be above the limit dose of 2000 mg/kg bw, since chromium picolinate monohydrate has not shown any acute oral toxicity up to the limit dose.   The approach for read-across is decribed in detail in the document attached in IUCLID section 13. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5f9310e-4e3f-4985-862f-9a2175f1b7fc/documents/364aa5f9-515a-4463-b725-26c2d3082087_9d24f340-686a-49f5-bce1-fd343e7505be.html,,,,,, Dichromium trioxalate,30737-19-0," Regardless of the high Cr3+ doses, chromium(III) oxide did not cause any significant treatment-related changes in the general condition of animals, body weights, clinical biochemistry, haematology, or pathological examination. The lack of toxicity of chromium(III) oxide can be explained by the poor bioavailability of this water-insoluble chromium compound. Faeces of treated animals showed an intense green discoloration, indicating significant excretion of the substance into faeces. Oxalic acid and associated oxalate salts are found in many foods and are formed in cells as a metabolite from glycolysis. Oxalates are readily excreted, although insoluble salts may build up causing renal effects (ie kidney stones). There is no toxicity theshold for repeated exposure in humans, although acute toxic effects have been reported in animals. The reported toxicity thresholds for oxalic acid appear in part due to local dermal and respiratory effects of a corrosive acid. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da0d06b3-082a-4a10-a7f4-88e82f7572e2/documents/7543c371-1233-4daa-bc57-9b8ff9b6d21a_efeb46fe-1dcc-4db3-a02a-e3eba3af7029.html,,,,,, Dichromium trioxalate,30737-19-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da0d06b3-082a-4a10-a7f4-88e82f7572e2/documents/7543c371-1233-4daa-bc57-9b8ff9b6d21a_efeb46fe-1dcc-4db3-a02a-e3eba3af7029.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat Dichromium trioxalate,30737-19-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da0d06b3-082a-4a10-a7f4-88e82f7572e2/documents/7543c371-1233-4daa-bc57-9b8ff9b6d21a_efeb46fe-1dcc-4db3-a02a-e3eba3af7029.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"44,000 mg/m3",,rat Dichromium trioxalate,30737-19-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da0d06b3-082a-4a10-a7f4-88e82f7572e2/documents/7543c371-1233-4daa-bc57-9b8ff9b6d21a_efeb46fe-1dcc-4db3-a02a-e3eba3af7029.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"44,000 mg/m3",no adverse effect observed,rat Dichromium trioxalate,30737-19-0," From extensive work on chromium III salts, there is no evidence of acute toxicity. Some corrosive salts will cause harm at high concentrations, but this is not considered to be a toxic effect.   Oxalic acid is classified Acute Tox 4 (oral and dermal) and anecdotal evidence suggest that the toxicity of salts is similar to the acid (ie the acid is not strong enough to be toxic by local contact). Renal problems have been reported in human overdose. Note that in a 70 day repeat dose diatary study, 5000 mg/kg/day oxalic acid was tolerated, but with renal problems. Administration in the diet is likely to have reduced uptake rates.   In view of the wealth of data on chromium salts and oxalates, no further animal testing is justified. It is accepted that there is no dermal absorption of metal salts such as chromium III from dermal contact.  The data for oxalic acid demonstrates potential for toxicity by the dermal route. The low oral toxicity also suggests low biological impact from contact with chromium III.  It is not considered to be justified to perform further animal tests. Skin penetration experiments on chromium chloride and chromium sulfate (1.2% chromium labelled with 51Cr) with skin chambers glued to the skin of normal volunteers. These chambers were removed at 6, 12, or 24 hours and analysis for radioactive chromium was performed at the site of the chamber as well as in the underlying epidermis and dermis. As no label was found in the lower levels of skin, it was concluded that chromium(III) salts did not permeate through the intact epidermis. Some blood samples and 24-h urine were also examined, and no radioactive chromium was detected.[Mali JWH, Van Kooten WJ, Van Neer CJ (1963) Some aspects of the behaviour of chromium compounds in the skin. Journal of Investigative Dermatology, 41:111–122]. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da0d06b3-082a-4a10-a7f4-88e82f7572e2/documents/3415d183-556c-4472-b1c3-5f48dd85f23c_efeb46fe-1dcc-4db3-a02a-e3eba3af7029.html,,,,,, Dichromium trioxalate,30737-19-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da0d06b3-082a-4a10-a7f4-88e82f7572e2/documents/3415d183-556c-4472-b1c3-5f48dd85f23c_efeb46fe-1dcc-4db3-a02a-e3eba3af7029.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Dicopper chloride trihydroxide,1332-65-6,"The pivotal repeat dose study was a 90-day study by the oral route with copper sulphate pentahydrate. In rats and mice, ingestion of copper sulphate pentahydrate produced forestomach lesions that could be to the irritant effects of the compound. The NOAEL for this effect was 16.7 mg Cu/kg bw/day in rats and 97 and 126 mg Cu/kg bw/day in male and female mice respectively. In rats inflammation of the liver was observed. The NOAEL’s for liver and kidney damage were 16.7 mg Cu/kg bw/day in rats. This is the pivotal study and the NOAEL of 16.7 mg Cu/kg bw/day will be used in the risk characterisation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6df511e1-e11b-4222-be34-dc2b4da8dd14/documents/81d3da45-92ab-4575-84fc-b790ca6cc998_f7a215b5-5fdd-45a4-8665-583397c03327.html,,,,,, Dicopper chloride trihydroxide,1332-65-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6df511e1-e11b-4222-be34-dc2b4da8dd14/documents/81d3da45-92ab-4575-84fc-b790ca6cc998_f7a215b5-5fdd-45a4-8665-583397c03327.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat Dicopper hydroxide phosphate,12158-74-6," The pivotal repeated dose study was a 90-day study by the oral route with copper sulphate pentahydrate. In rats and mice, ingestion of copper sulphate pentahydrate produced forestomach lesions that could be to the irritant effects of the compound. The NOAEL for this effect was 16.7 mg Cu/kg bw/day in rats and 97 and 126 mg Cu/kg bw/day in male and female mice respectively. In rats inflammation of the liver was observed. The NOAEL’s for liver and kidney damage were 16.7 mg Cu/kg bw/day in rats. This is the pivotal study and the NOAEL of 16.7 mg Cu/kg bw/day will be used in the risk characterisation. The study LOEC is 0.2 mg cuprous oxide/m3, as (non-adverse) effects were seen at this dose. The study NOAEC is >= 2 mg/kg cuprous oxide/m3, the highest dose level tested and based on the lack of findings in the lung weight ratio. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4410ad28-f756-4575-b117-47efacad44b1/documents/IUC5-4ac99902-8099-4cff-bea2-9ea8f37179e6_d3ab04a1-a362-449b-aeb4-c1d8e7720d5e.html,,,,,, Dicopper hydroxide phosphate,12158-74-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4410ad28-f756-4575-b117-47efacad44b1/documents/IUC5-4ac99902-8099-4cff-bea2-9ea8f37179e6_d3ab04a1-a362-449b-aeb4-c1d8e7720d5e.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,2 mg/m3,,rat Dicopper hydroxide phosphate,12158-74-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4410ad28-f756-4575-b117-47efacad44b1/documents/IUC5-4ac99902-8099-4cff-bea2-9ea8f37179e6_d3ab04a1-a362-449b-aeb4-c1d8e7720d5e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat Dicopper hydroxide phosphate,12158-74-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4410ad28-f756-4575-b117-47efacad44b1/documents/IUC5-4ac99902-8099-4cff-bea2-9ea8f37179e6_d3ab04a1-a362-449b-aeb4-c1d8e7720d5e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,2 mg/m3,no adverse effect observed,rat Dicopper hydroxide phosphate,12158-74-6, Key studies exist for all three acute toxicity endpoints; these studies are conducted in accordance with appropriate guidelines and under the conditions of GLP. As such these data are considered to be adequate and reliable for use as a key study in accordance with Regulation (EC) No. 1907/2006 (REACH) and for classification and labelling in accordance with Regulation (EC) No. 1272/2008 (EU CLP). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4410ad28-f756-4575-b117-47efacad44b1/documents/IUC5-aaf86bf1-e706-4d92-859e-2d2b3640b0ed_d3ab04a1-a362-449b-aeb4-c1d8e7720d5e.html,,,,,, Dicopper hydroxide phosphate,12158-74-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4410ad28-f756-4575-b117-47efacad44b1/documents/IUC5-aaf86bf1-e706-4d92-859e-2d2b3640b0ed_d3ab04a1-a362-449b-aeb4-c1d8e7720d5e.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Dicopper hydroxide phosphate,12158-74-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4410ad28-f756-4575-b117-47efacad44b1/documents/IUC5-aaf86bf1-e706-4d92-859e-2d2b3640b0ed_d3ab04a1-a362-449b-aeb4-c1d8e7720d5e.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Dicopper hydroxide phosphate,12158-74-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4410ad28-f756-4575-b117-47efacad44b1/documents/IUC5-aaf86bf1-e706-4d92-859e-2d2b3640b0ed_d3ab04a1-a362-449b-aeb4-c1d8e7720d5e.html,,inhalation,discriminating conc.,"5,090 mg/m3",no adverse effect observed, Dicopper sulphide,22205-45-4,"The pivotal repeat dose study was a 90-day study by the oral route with copper sulphate pentahydrate.  In rats and mice, ingestion of copper sulphate pentahydrate produced forestomach lesions that could be to the irritant effects of the compound.  The NOAEL for this effect was 16.7 mg Cu/kg bw/day in rats and 97 and 126 mg Cu/kg bw/day in male and female mice respectively. In rats inflammation of the liver was observed.  The NOAEL’s for liver and kidney damage were 16.7 mg Cu/kg bw/day in rats.  This is the pivotal study and the NOAEL of 16.7 mg Cu/kg bw/day will be used in the risk characterisation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f159e0aa-2ffc-44db-bb7b-4b4bb09e236a/documents/c390df7f-8430-4d85-bbeb-1bf2777f0f2c_c5fa9ce4-8fc2-497e-961a-bf2b9d633263.html,,,,,, Dicopper sulphide,22205-45-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f159e0aa-2ffc-44db-bb7b-4b4bb09e236a/documents/c390df7f-8430-4d85-bbeb-1bf2777f0f2c_c5fa9ce4-8fc2-497e-961a-bf2b9d633263.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat Dicyclohexylamine,101-83-7,"Repeated oral dose toxicity was assessed by a subacute toxicity study (28 days, Japanese Guideline) and in an OECD TG 421 assay in rats. Unspecific signs of intoxication in combination with changes in organ weights (adrenal glands, ovaries, testes) at the highest doses tested without histopathological correlates resulted in NOAELs (general toxicity) of 20 mg/kg bw/day (subacute study) or 40 mg/kg bw/day (OECD TG 421) for rats of both sexes, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5560074c-5463-4464-b9c8-b883581eb27e/documents/IUC5-be604513-8b55-4c46-b51f-8ea8b18d5f5f_8d8f26f3-61ae-4f74-9329-b3e92187f1d3.html,,,,,, Dicyclohexylamine,101-83-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5560074c-5463-4464-b9c8-b883581eb27e/documents/IUC5-be604513-8b55-4c46-b51f-8ea8b18d5f5f_8d8f26f3-61ae-4f74-9329-b3e92187f1d3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat Dicyclohexylamine,101-83-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5560074c-5463-4464-b9c8-b883581eb27e/documents/IUC5-be604513-8b55-4c46-b51f-8ea8b18d5f5f_8d8f26f3-61ae-4f74-9329-b3e92187f1d3.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,40 mg/kg bw/day,, Dicyclohexylamine,101-83-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5560074c-5463-4464-b9c8-b883581eb27e/documents/IUC5-be604513-8b55-4c46-b51f-8ea8b18d5f5f_8d8f26f3-61ae-4f74-9329-b3e92187f1d3.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,35.3 mg/m3,, Dicyclohexylamine,101-83-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5560074c-5463-4464-b9c8-b883581eb27e/documents/IUC5-84e9529a-8263-430d-b7da-050ed5f1177c_8d8f26f3-61ae-4f74-9329-b3e92187f1d3.html,,oral,LD50,200 mg/kg bw,, Dicyclohexylamine,101-83-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5560074c-5463-4464-b9c8-b883581eb27e/documents/IUC5-84e9529a-8263-430d-b7da-050ed5f1177c_8d8f26f3-61ae-4f74-9329-b3e92187f1d3.html,,dermal,LD50,200 mg/kg bw,, Dicyclohexylcarbodiimide,538-75-0," Repeated dose toxicity: oral. Key study. Method similar to OECD 407, GLP study. The NOEL for the subacute oral repeated dose toxicity was determined to be 100 mg/kg bw/day in male and female rats. Repeated dose toxicity: dermal. Weight of evidence: In a 13-week subchronic dermal toxicity study performed on the test item by the NTP, method similar to OECD 411 (GLP study), the NOAEL for the subchronic dermal toxicity of the test item in rats was 3 mg/kg bw in males and 6 mg/kg bw in females. In a 13 -week subchronic dermal toxicity study performed on the test item by the NTP, method similar to OECD 411 (GLP study), the NOAEL for the subchronic dermal toxicity of the test item in mice was 3 mg/kg bw in males and in females. In a 16-day repeated dose dermal study in F-344 rats by the NTP (GLP study), the NOAEL was found to be ca. 12 mg/kg bw in rats. The same study performed in B6C3F1 male and female mice gave a NOAEL of ca. 8 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83a352d9-058e-4360-92dd-fbf796e8072a/documents/a70614b8-7e03-465d-b794-fb2e44112ca8_490e3d76-86b4-4de4-9e8e-851b4c52421f.html,,,,,, Dicyclohexylcarbodiimide,538-75-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83a352d9-058e-4360-92dd-fbf796e8072a/documents/a70614b8-7e03-465d-b794-fb2e44112ca8_490e3d76-86b4-4de4-9e8e-851b4c52421f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Dicyclohexylcarbodiimide,538-75-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83a352d9-058e-4360-92dd-fbf796e8072a/documents/a70614b8-7e03-465d-b794-fb2e44112ca8_490e3d76-86b4-4de4-9e8e-851b4c52421f.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,3 mg/kg bw/day,,rat Dicyclohexylcarbodiimide,538-75-0," Acute oral toxicity: Key study: Method according to OECD 401, GLP study. The acute oral toxicity LD50 of the test item in rats was 1110 mg/kg bw (both sexes). Supporting studies: Peer reviewed handbook data reported a LD50 of 400 mg/kg in rats and > 800 mg/kg in mice. Acute inhalation toxicity: Based on peer-reviewed handbook data, the test item has an acute inhalation LC50 of 159 mg/m3 in rats. Data waiving (study scientifically not necessary / other information available): The substance is not classified for acute inhalatory toxicity, according to Annex VI of CLP Regulation (EC) no. 1272/2008. Acute dermal toxicity: Based on peer-reviewed handbook data, the test item has an acute dermal LD50 of 10 ml/kg in guinea pigs. Data waiving (study scientifically not necessary / other information available): The substance classified as Acute Toxicity, Category 3, according to Annex VI of CLP Regulation (EC) no. 1272/2008. Acute toxicity: other routes. Peer reviewed handbook data reports an intraperitoneal acute toxicity LC50 value of 10 mg/kg in rats and an intraperitoneal acute toxicity value > 800 mg/kg in mice. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83a352d9-058e-4360-92dd-fbf796e8072a/documents/0cb2226f-b0f6-48af-a459-eb2a7ba1146c_490e3d76-86b4-4de4-9e8e-851b4c52421f.html,,,,,, Dicyclohexylcarbodiimide,538-75-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83a352d9-058e-4360-92dd-fbf796e8072a/documents/0cb2226f-b0f6-48af-a459-eb2a7ba1146c_490e3d76-86b4-4de4-9e8e-851b4c52421f.html,,oral,LD50,"1,110 mg/kg bw",adverse effect observed, Dicyclohexylcarbodiimide,538-75-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83a352d9-058e-4360-92dd-fbf796e8072a/documents/0cb2226f-b0f6-48af-a459-eb2a7ba1146c_490e3d76-86b4-4de4-9e8e-851b4c52421f.html,,dermal,LD50,10 mg/kg bw,adverse effect observed, Dicyclohexylcarbodiimide,538-75-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83a352d9-058e-4360-92dd-fbf796e8072a/documents/0cb2226f-b0f6-48af-a459-eb2a7ba1146c_490e3d76-86b4-4de4-9e8e-851b4c52421f.html,,inhalation,LC50,159 mg/m3,adverse effect observed, Dicyclopentyldimethoxysilane,126990-35-0," In the key sub-acute oral toxicity study in rats with dicyclopentyl(dimethoxy)silane (CAS 126990-35-0) conducted according to OECD Test Guideline 407 and in compliance with GLP, the NOAEL was at least 1000 mg/kg bw/day, the highest dose tested (Huntingdon Life Sciences Ltd, 1995a). There are no sub-chronic toxicity data for the registered substance, but data is available for the silanol hydrolysis product, dicyclopentylsilanediol. In this key oral gavage toxicity study in rats conducted according to a protocol equivalent to OECD Test Guideline 408 and in compliance with GLP, the NOAEL for dicyclopentylsilanediol was 200 mg/kg bw/day for females and 1000 mg/kg bw/day for males. A molecular weight correction is used to establish the corresponding dose of parent dicyclopentyl(dimethoxy)silane that would provide 200 mg/kg bw/day of dicyclopentylsilanediol. The overall NOAEL of 200 mg/kg bw/day as silanol is equivalent to a dose of approximately 230 mg/kg bw/day as parent dicyclopentyl(dimethoxy)silane (Mitsubishi Chemical Safety Institute, 2000). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76966aaf-12e9-4cdf-837c-4ed3832888c7/documents/12eab12e-0623-4608-b345-be49709d79f1_feb98a5d-c278-4780-98ef-229bf3697f5e.html,,,,,, Dicyclopentyldimethoxysilane,126990-35-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76966aaf-12e9-4cdf-837c-4ed3832888c7/documents/12eab12e-0623-4608-b345-be49709d79f1_feb98a5d-c278-4780-98ef-229bf3697f5e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,230 mg/kg bw/day,,rat Dicyclopentyldimethoxysilane,126990-35-0," In an acute oral toxicity study conducted to the now deleted OECD Test Guideline 401 and in compliance with GLP, the LD50 for dicyclopentyl(dimethoxy)silane (CAS 126990-35-0) was greater than 2000 mg/kg bw in rats (Safepharm Laboratories Ltd., 1995a). In an acute inhalation study conducted using a protocol similar to OECD Test Guideline 403 and in compliance with GLP, the LC50 for dicyclopentyl(dimethoxy)silane was greater than 22 ppm, as no deaths occurred following a 4-hour exposure to this concentration. This concentration appeared to be the highest attainable under the conditions of this study (DCC, 1993). In an acute dermal toxicity study conducted according to an EU guideline (EU Method B.3 (Acute Toxicity (Dermal)) and in compliance with GLP, the LD50 for dicyclopentyl(dimethoxy)silane was greater than 2000 mg/kg bw in rats (Huntingdon Research Centre Ltd., 1995b). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76966aaf-12e9-4cdf-837c-4ed3832888c7/documents/19f26bac-5880-464b-8927-44a9ec627cc8_feb98a5d-c278-4780-98ef-229bf3697f5e.html,,,,,, Dicyclopentyldimethoxysilane,126990-35-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76966aaf-12e9-4cdf-837c-4ed3832888c7/documents/19f26bac-5880-464b-8927-44a9ec627cc8_feb98a5d-c278-4780-98ef-229bf3697f5e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dicyclopentyldimethoxysilane,126990-35-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76966aaf-12e9-4cdf-837c-4ed3832888c7/documents/19f26bac-5880-464b-8927-44a9ec627cc8_feb98a5d-c278-4780-98ef-229bf3697f5e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dicyclopentyldimethoxysilane,126990-35-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76966aaf-12e9-4cdf-837c-4ed3832888c7/documents/19f26bac-5880-464b-8927-44a9ec627cc8_feb98a5d-c278-4780-98ef-229bf3697f5e.html,,inhalation,LC50,205.52 mg/m3,no adverse effect observed, Didocosyl sebacate,42233-75-0,"RDT oral (OECD guideline 407), rat NOEL = 1000 mg/kg bw/day (males); NOAEL = 1000 mg/kg bw/day (females) RDT oral (OECD guideline 408), rat NOEL 1000 mg/kg bw/day (males/females)Waiving – RDT inhalation Waiving – RDT dermal ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a51ed29-9420-475c-a1b0-e689f25474ea/documents/IUC5-90c4685d-aa64-4f10-9b6c-3f25ded16ab5_86424f03-74c3-44b8-940b-32c883833a0c.html,,,,,, Didocosyl sebacate,42233-75-0,"Oral LD50 (OECD 420), rat > 2000 mg/kg bw Dermal LD50 (OECD 402), rat > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a51ed29-9420-475c-a1b0-e689f25474ea/documents/IUC5-02d62258-067f-40a0-b4bb-8697f6b8ce3c_86424f03-74c3-44b8-940b-32c883833a0c.html,,,,,, Didodecyl fumarate,2402-58-6,"In conclusion, no human hazard for systemic toxicity after repeated oral exposure was identified for the PFAE fumarate category members. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ceb2b84-b96f-4bbc-bc69-3393736a20f3/documents/IUC5-b1e1cf83-e603-488a-adbe-173c9196f05b_2a902a0a-8820-4d55-923e-54ff725237c9.html,,,,,, Didodecyl fumarate,2402-58-6,The available acute oral toxicity study within this category (according to OECD TG 423) resulted in an acute oral LD50 value > 5000 mg/kg bw. The available acute dermal toxicity study within the category (according to OECD TG 402) resulted in an acute dermal LD50 value > 5000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ceb2b84-b96f-4bbc-bc69-3393736a20f3/documents/IUC5-f2b691a0-9c18-4d3a-8883-615fc8e5718d_2a902a0a-8820-4d55-923e-54ff725237c9.html,,,,,, Diethoxy(dimethyl)silane,78-62-6,"Combined repeated dose toxicity study with reproductive/developmental toxicity screening test (OECD 422, oral, rat): NOAEL systemic = 300 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a012c372-1191-4f9c-a90b-7f8d8262d09e/documents/72736b6d-1475-41fa-bb44-965ef7f3d618_61e6e820-9a90-4288-bc75-51978fe59ae1.html,,,,,, Diethoxy(dimethyl)silane,78-62-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a012c372-1191-4f9c-a90b-7f8d8262d09e/documents/72736b6d-1475-41fa-bb44-965ef7f3d618_61e6e820-9a90-4288-bc75-51978fe59ae1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Diethoxy(dimethyl)silane,78-62-6,"Oral (similar to OECD 401), rat: LD50 = 10170 mg/kg bw Inhalation (OCED TG 403), rat, 6 h exposure: LC50 > 42100 mg/m³ (limit test) (RA from CAS 1185-55-3) Inhalation (OCED TG 403), rat, 4 h exposure: LC50 > 4700 mg/m³ (limit test) (RA from CAS 1112-39-6) Inhalation (OCED TG 403), rat, 4 h exposure: LC50 > 13500 mg/m³ (limit test) (RA from CAS 2031-67-6) Dermal (similar to OECD 402), rabbit: LD50 = 14400 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a012c372-1191-4f9c-a90b-7f8d8262d09e/documents/cbdb4f9d-9fda-41f0-ac80-3c872535449e_61e6e820-9a90-4288-bc75-51978fe59ae1.html,,,,,, Diethoxy(dimethyl)silane,78-62-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a012c372-1191-4f9c-a90b-7f8d8262d09e/documents/cbdb4f9d-9fda-41f0-ac80-3c872535449e_61e6e820-9a90-4288-bc75-51978fe59ae1.html,,oral,LD50,"10,170 mg/kg bw",no adverse effect observed, Diethoxy(dimethyl)silane,78-62-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a012c372-1191-4f9c-a90b-7f8d8262d09e/documents/cbdb4f9d-9fda-41f0-ac80-3c872535449e_61e6e820-9a90-4288-bc75-51978fe59ae1.html,,dermal,LD50,"14,400 mg/kg bw",no adverse effect observed, Diethoxy(dimethyl)silane,78-62-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a012c372-1191-4f9c-a90b-7f8d8262d09e/documents/cbdb4f9d-9fda-41f0-ac80-3c872535449e_61e6e820-9a90-4288-bc75-51978fe59ae1.html,,inhalation,LC50,"> 4,700 mg/m3",no adverse effect observed, Diethoxy(methyl)silane,2031-62-1," Combined repeated dose toxicity study with reproductive/developmental toxicity screening test (RA-A CAS 78 -62 -6, OECD 422, oral, rat): NOAEL systemic = 300 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e22d1a2-4da7-4e70-b156-cf42c732d582/documents/7afb1778-f92c-4c82-b736-f6923e386c86_465279d2-a2e2-45a6-a01c-9a4070362353.html,,,,,, Diethoxy(methyl)silane,2031-62-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e22d1a2-4da7-4e70-b156-cf42c732d582/documents/7afb1778-f92c-4c82-b736-f6923e386c86_465279d2-a2e2-45a6-a01c-9a4070362353.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Diethoxy(methyl)silane,2031-62-1,Oral (OECD 423): LD50 > 2000 mg/kg bw Inhalation (OECD 403): LC50 = 4731 ppm (males/females) Dermal (OECD 402): LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e22d1a2-4da7-4e70-b156-cf42c732d582/documents/IUC5-de9600af-90ff-403d-9a6b-b0a0fe321cc2_465279d2-a2e2-45a6-a01c-9a4070362353.html,,,,,, "Diethyl [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate",976-56-7," Repeated dose toxicity was assessed with data obtained for a structural analogue: In a 90-day feeding study with dogs (Beagle) a NOAEL of 84.1 (males) and 90.2 mg/kg bw/day (females) was derived. No treatment-related effects have been observed. in a 90-day feeding study with Sprague-Dawley rats, a NOEL of 122 (males) and 136 mg/kg bw/day (females) was derived. Slight impairment of growth during the first 6 weeks of treatment, lower efficiency of food utilisation and elevated SAP levels among males were reported. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/23c1b606-5de5-4c84-a2c8-daeba063f861/documents/56418a13-3d42-4229-af14-606793964a8f_186fa39a-9913-4cb7-940d-f4eb7e6ae24d.html,,,,,, "Diethyl [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate",976-56-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/23c1b606-5de5-4c84-a2c8-daeba063f861/documents/56418a13-3d42-4229-af14-606793964a8f_186fa39a-9913-4cb7-940d-f4eb7e6ae24d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,84 mg/kg bw/day,,dog "Diethyl [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate",976-56-7, The acute oral toxicity study in rats was revealed an LD50 value of >7750 mg/kg bw. In an acute dermal toxicity study conducted on rabbits the LD50 value was found to be greater than 5000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23c1b606-5de5-4c84-a2c8-daeba063f861/documents/1b1d7acd-dfd3-4a54-8680-b7f2c70af3a4_186fa39a-9913-4cb7-940d-f4eb7e6ae24d.html,,,,,, "Diethyl [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate",976-56-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23c1b606-5de5-4c84-a2c8-daeba063f861/documents/1b1d7acd-dfd3-4a54-8680-b7f2c70af3a4_186fa39a-9913-4cb7-940d-f4eb7e6ae24d.html,,oral,discriminating dose,"7,750 mg/kg bw",no adverse effect observed, "Diethyl [[3,5-bis(1,1-dimethylethyl)-4-hydroxyphenyl]methyl]phosphonate",976-56-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23c1b606-5de5-4c84-a2c8-daeba063f861/documents/1b1d7acd-dfd3-4a54-8680-b7f2c70af3a4_186fa39a-9913-4cb7-940d-f4eb7e6ae24d.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "diethyl 1-(2,4-dichlorophenyl)-5-methyl-4,5-dihydro-1H-pyrazole-3,5-dicarboxylate",135590-91-9," Subacute toxicity: Oral toxicity (OECD 407), 28 days, rat: NOAEL = 102.0 mg/kg bw/day (males) and 101.4 mg/kg bw/day (females) Oral toxicity (OECD 407), 28 days, mouse (male/female): NOAEL = 1100 mg/kg bw/day Oral toxicity (shortened OECD 409), 30 days, dog (male/female): NOAEL = 342 mg/kg bw/day Dermal toxicity (OECD 410), 29 days, rat (male/female): NOAEL = 300 mg/kg bw/day   Subchronic toxicity: Oral toxicity (OECD 408), 90 days, rat: NOAEL 42.1 mg/kg bw/day (males) and 44.3 mg/kg bw/day (females) Oral toxicity (OECD 408), 90 days, mouse: NOAEL 89.3 mg/kg bw/day (males) and 105.4 mg/kg bw/day (females) Oral toxicity (OECD 409), 90 days, dog (male/female): NOAEL = 81 mg/kg bw/day   Chronic toxicity: Oral toxicity (OECD 453), 104 weeks, rat: NOAEL = 48.47 mg/kg bw/d (males) and 59.98 mg/kg bw/d (females) Oral toxicity (OECD 452), 52 weeks, dog (male/female): NOAEL = 55 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8aa7733-6a69-4295-829d-c280e02c6af6/documents/96804cc9-db89-471c-be2d-60a390a53405_3214cfaa-d301-49c0-990d-406cbc976511.html,,,,,, "diethyl 1-(2,4-dichlorophenyl)-5-methyl-4,5-dihydro-1H-pyrazole-3,5-dicarboxylate",135590-91-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8aa7733-6a69-4295-829d-c280e02c6af6/documents/96804cc9-db89-471c-be2d-60a390a53405_3214cfaa-d301-49c0-990d-406cbc976511.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,300 mg/kg bw/day,,rat "diethyl 1-(2,4-dichlorophenyl)-5-methyl-4,5-dihydro-1H-pyrazole-3,5-dicarboxylate",135590-91-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8aa7733-6a69-4295-829d-c280e02c6af6/documents/96804cc9-db89-471c-be2d-60a390a53405_3214cfaa-d301-49c0-990d-406cbc976511.html,Chronic toxicity – systemic effects,oral,NOAEL,48.47 mg/kg bw/day,,rat "diethyl 1-(2,4-dichlorophenyl)-5-methyl-4,5-dihydro-1H-pyrazole-3,5-dicarboxylate",135590-91-9," Acute oral toxicity (OECD 401), rat: LD50 > 5000 mg/kg bw Acute oral toxicity (OECD 401), mouse: LD50 > 5000 mg/kg bw Acute dermal toxicity (OECD 402), rat: LD50 > 4000 mg/kg bw Acute inhalation toxicity (OECD 403), rat (4 h exposure): LC50 > 1.32 mg/L air ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8aa7733-6a69-4295-829d-c280e02c6af6/documents/2a851fb4-9512-4a5a-84f3-38fed43fa6a8_3214cfaa-d301-49c0-990d-406cbc976511.html,,,,,, "diethyl 1-(2,4-dichlorophenyl)-5-methyl-4,5-dihydro-1H-pyrazole-3,5-dicarboxylate",135590-91-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8aa7733-6a69-4295-829d-c280e02c6af6/documents/2a851fb4-9512-4a5a-84f3-38fed43fa6a8_3214cfaa-d301-49c0-990d-406cbc976511.html,,dermal,LD50,"4,000 mg/kg bw",no adverse effect observed, "diethyl 1-(2,4-dichlorophenyl)-5-methyl-4,5-dihydro-1H-pyrazole-3,5-dicarboxylate",135590-91-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8aa7733-6a69-4295-829d-c280e02c6af6/documents/2a851fb4-9512-4a5a-84f3-38fed43fa6a8_3214cfaa-d301-49c0-990d-406cbc976511.html,,inhalation,LC50,1.32 mg/m3,no adverse effect observed, "diethyl 1,4-cyclohexanedicarboxylate",72903-27-6," NOAEL = 1000 mg/kg bw/d (OECD 407, GLP, K, rel. 1) NOAEL = 1000 mg/kg bw/day (OECD 408, GLP, K, rel.1) - read-across to Cyclohexane-1,4-dicarboxylic acid ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d1edc131-a867-4d99-a9e0-b4e8d9f8e251/documents/IUC5-893cc55c-8ef1-42e8-8a93-5f1b9991faf2_ead7a98f-eccb-4bfb-9f6e-d7390fd7a419.html,,,,,, "diethyl 1,4-cyclohexanedicarboxylate",72903-27-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d1edc131-a867-4d99-a9e0-b4e8d9f8e251/documents/IUC5-893cc55c-8ef1-42e8-8a93-5f1b9991faf2_ead7a98f-eccb-4bfb-9f6e-d7390fd7a419.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "diethyl 1,4-cyclohexanedicarboxylate",72903-27-6,"Acute toxicity: oral: LD50combined > 2000 mg/kg bw (OECD 420, GLP, K, rel. 1)Acute toxicity: dermal: LD50combined > 2000 mg/kg bw (OECD 402, GLP, K, rel. 1)Acute toxicity: inhalation: Waiver ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1edc131-a867-4d99-a9e0-b4e8d9f8e251/documents/IUC5-e49c004e-ff3d-4a39-8f6e-0855d7cee653_ead7a98f-eccb-4bfb-9f6e-d7390fd7a419.html,,,,,, "diethyl 1,4-cyclohexanedicarboxylate",72903-27-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1edc131-a867-4d99-a9e0-b4e8d9f8e251/documents/IUC5-e49c004e-ff3d-4a39-8f6e-0855d7cee653_ead7a98f-eccb-4bfb-9f6e-d7390fd7a419.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "diethyl 1,4-cyclohexanedicarboxylate",72903-27-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1edc131-a867-4d99-a9e0-b4e8d9f8e251/documents/IUC5-e49c004e-ff3d-4a39-8f6e-0855d7cee653_ead7a98f-eccb-4bfb-9f6e-d7390fd7a419.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Diethyl 4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4,5-dihydro-5-oxo-1-phenyl-1H-pyrazole-3-carboxylate]",6358-87-8," In the “Combined Repeated Dose Oral Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test” of the structure analogue Pigment Orange 34, the no observed adverse effect level (NOAEL) is considered to be 1000 mg/kg body weight/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a187aea1-1c47-4277-8c2a-852baa824305/documents/9be9e5be-14aa-46c4-9ad9-7c3113373d91_996d71aa-c214-4c6f-8a61-33e286ff5220.html,,,,,, "Diethyl 4,4'-[(3,3'-dichloro[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[4,5-dihydro-5-oxo-1-phenyl-1H-pyrazole-3-carboxylate]",6358-87-8," Oral: LD50 (strucrue analogue Pigment Orange 13, nano form) >2100 mg/kg LD50 (strucrue analogue Pigment Orange 34, nano form) >15000 mg/kg   Inhalation: Waiving   Dermal: LD50 (Pigment Orange 38, nano form) >2000 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a187aea1-1c47-4277-8c2a-852baa824305/documents/35de01f3-5617-4e88-a7b2-fc208b300a3b_996d71aa-c214-4c6f-8a61-33e286ff5220.html,,,,,, Diethyl acetamidomalonate,1068-90-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/439626b0-ce08-44b4-8411-26d89eabd044/documents/956c5e94-9302-4ca4-b70b-db1a0e4b8f15_7a13313b-d324-431c-bfb8-b915e6298b4d.html,,oral,LD50,500 mg/kg bw,, Diethyl acetylsuccinate,1115-30-6,"The LD50,oral,rat is higher than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21f923bb-b070-4c39-8b6b-24493e7fc916/documents/IUC5-7a17f5c7-5bc8-4873-addc-b808b4d9bcd5_d40d5a07-65f2-464d-ab2c-216a8830e5cb.html,,,,,, Diethyl acetylsuccinate,1115-30-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21f923bb-b070-4c39-8b6b-24493e7fc916/documents/IUC5-7a17f5c7-5bc8-4873-addc-b808b4d9bcd5_d40d5a07-65f2-464d-ab2c-216a8830e5cb.html,,oral,LD50,"2,000 mg/kg bw",, Diethyl bis(2-hydroxyethyl)aminomethylphosphonate,2781-11-5,"NOAEL ≥ 500 mg/kg bw/day (highest dose tested) (eq. OECD 408, Key, Rel.2) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec5cc7f4-3e5a-4e5f-bd79-665df98a9b49/documents/fe4d76fc-21dc-4da0-9945-2f2e00cbcaf9_de1a0fcf-61b2-41e3-ae19-cc7f22f525ea.html,,,,,, Diethyl bis(2-hydroxyethyl)aminomethylphosphonate,2781-11-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec5cc7f4-3e5a-4e5f-bd79-665df98a9b49/documents/fe4d76fc-21dc-4da0-9945-2f2e00cbcaf9_de1a0fcf-61b2-41e3-ae19-cc7f22f525ea.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Diethyl bis(2-hydroxyethyl)aminomethylphosphonate,2781-11-5,"Acute toxicity via Oral route: Combined Rat LD50 > 5000 mg/kg bw (OECD 401, K, Rel.2).Acute toxicity via Dermal route: Combined Rabbit LD50 > 2000 mg/kg bw (OECD 402, K, Rel.2).Acute toxicity via Inhalation route: Combined Rat LC50 > 520 mg/m3 (eq. OECD 403, K, Rel.2) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec5cc7f4-3e5a-4e5f-bd79-665df98a9b49/documents/8e991a77-4944-435a-b27a-f1b85ec58149_de1a0fcf-61b2-41e3-ae19-cc7f22f525ea.html,,,,,, Diethyl bis(2-hydroxyethyl)aminomethylphosphonate,2781-11-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec5cc7f4-3e5a-4e5f-bd79-665df98a9b49/documents/8e991a77-4944-435a-b27a-f1b85ec58149_de1a0fcf-61b2-41e3-ae19-cc7f22f525ea.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Diethyl bis(2-hydroxyethyl)aminomethylphosphonate,2781-11-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec5cc7f4-3e5a-4e5f-bd79-665df98a9b49/documents/8e991a77-4944-435a-b27a-f1b85ec58149_de1a0fcf-61b2-41e3-ae19-cc7f22f525ea.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Diethyl bis(2-hydroxyethyl)aminomethylphosphonate,2781-11-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec5cc7f4-3e5a-4e5f-bd79-665df98a9b49/documents/8e991a77-4944-435a-b27a-f1b85ec58149_de1a0fcf-61b2-41e3-ae19-cc7f22f525ea.html,,inhalation,LC50,> 520 mg/m3,no adverse effect observed, Diethyl butylmalonate,133-08-4," There is no data available for diethyl butylmalonate (CAS # 133 -08 -4). For C&L purposes, the following data available for structurally similar substances cited in the 2006 OECD SIDS “malonic acid diesters” (UNEP Publications, Final 10/2006) is suitable for read across: Dimethylmalonate, CAS # 108-59-8 OECD 422 NOAEL = 300 mg/kg  Diethylmalonate, CAS # 105-53-3 Limited study with NOAEL in the only dose level tested ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c5a7a629-add4-4fbf-aa54-788729e20f7c/documents/4521ebbf-23dc-43a6-879f-c6ffce7eb541_13da1650-dfaa-4839-adb0-a68462f703e4.html,,,,,, Diethyl butylmalonate,133-08-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c5a7a629-add4-4fbf-aa54-788729e20f7c/documents/4521ebbf-23dc-43a6-879f-c6ffce7eb541_13da1650-dfaa-4839-adb0-a68462f703e4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Diethyl butylmalonate,133-08-4," There is no data available for diethyl butylmalonate (CAS # 133 -08 -4). For C&L purposes, the following data available for structurally similar substances cited in the 2006 OECD SIDS “malonic acid diesters” (UNEP Publications, Final 10/2006) is suitable for read across: Dimethylmalonate, CAS # 108-59-8 LD50(oral) > 2000 mg/kg LD50(dermal) > 2000 mg/kg   Diethylmalonate, CAS # 105-53 -3 LD50(oral) = 15794 mg/kg LD50(dermal) > 16960 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5a7a629-add4-4fbf-aa54-788729e20f7c/documents/24a37830-74f9-49d2-bf8b-be4cd2f97931_13da1650-dfaa-4839-adb0-a68462f703e4.html,,,,,, Diethyl butylmalonate,133-08-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5a7a629-add4-4fbf-aa54-788729e20f7c/documents/24a37830-74f9-49d2-bf8b-be4cd2f97931_13da1650-dfaa-4839-adb0-a68462f703e4.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Diethyl butylmalonate,133-08-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5a7a629-add4-4fbf-aa54-788729e20f7c/documents/24a37830-74f9-49d2-bf8b-be4cd2f97931_13da1650-dfaa-4839-adb0-a68462f703e4.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Diethyl phenylphosphonite,1638-86-4,Oral:LD50 > 2000mg/kg Inhalation: 2/6 animals died after either 4 or 7h exposure to the saturated vapour concentration ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46606f6c-ca87-43cc-b8b4-2878181b81ae/documents/IUC5-b3a198bf-499a-4fa3-b123-746a3ff0bd98_2e12906c-e7f0-454c-990c-ba8a2e1589eb.html,,,,,, Diethyl phenylphosphonite,1638-86-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46606f6c-ca87-43cc-b8b4-2878181b81ae/documents/IUC5-b3a198bf-499a-4fa3-b123-746a3ff0bd98_2e12906c-e7f0-454c-990c-ba8a2e1589eb.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Diethyl phenylphosphonite,1638-86-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46606f6c-ca87-43cc-b8b4-2878181b81ae/documents/IUC5-b3a198bf-499a-4fa3-b123-746a3ff0bd98_2e12906c-e7f0-454c-990c-ba8a2e1589eb.html,,inhalation,discriminating conc.,0.32 mg/m3,adverse effect observed, Diethyl phosphorochloridate,814-49-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e1f5e59-e8c5-4969-8a7c-efeb4f3b9b5f/documents/443c5c99-ad76-4009-911c-486d7f52b951_a130ccd7-fdee-4303-8ed1-3b111978a50c.html,,oral,LD50,11 mg/kg bw,, Diethyl phosphorochloridate,814-49-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e1f5e59-e8c5-4969-8a7c-efeb4f3b9b5f/documents/443c5c99-ad76-4009-911c-486d7f52b951_a130ccd7-fdee-4303-8ed1-3b111978a50c.html,,dermal,LD50,0.008 mg/kg bw,, "Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1)",68527-63-9,"The substance Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1), was examined in a Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test according to OECD 422.0, 13, 40 and 130 mg/kg bw daily oral doses were administered to Wistar rats. Based on the data, it can be concluded that the oral administration of test substance in male and female Wistar rats produced lesions of varied degrees in liver of both males and females. These lesions correlated only in G4 males with increased AST serum level and seem to be test item related in this dosage but cannot clearly interpreted as test item related in the lower dose groups of both sexes as several lesions were also found in the control groups. The lesions in testes and epididymis along with increased serum AST, calcium and phosphorous levels in males at 130 mg/kg body weight is considered test item related; whereas lesions in testes and epididymis along with increased serum calcium and phosphorous levels in males at 40 mg/kg body weight is considered to be test item related. However, no adverse pathological alterations were observed in the low dose group of male animals. In females no adverse pathological alterations can be interpreted as test item related except some more alterations in the liver in the highest dose group as compared to the control.Based on the observed effects, following effect levels have been calculated: • NOAEL for general toxicity in males: 13 mg/kg bw• NOAEL for general toxicity in females: 40 mg/kg bw Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): guideline study reliable without restriction ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3946667b-7187-4795-a536-76a1ef7a534a/documents/65bce8ee-5ec4-4cb7-92d5-8ecdc94834f6_1ad3095a-4c7f-4e02-b92c-726b3ed45ce7.html,,,,,, "Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1)",68527-63-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3946667b-7187-4795-a536-76a1ef7a534a/documents/65bce8ee-5ec4-4cb7-92d5-8ecdc94834f6_1ad3095a-4c7f-4e02-b92c-726b3ed45ce7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,13 mg/kg bw/day,,rat "Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1)",68527-63-9,"The acute oral toxicity of Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1) was examined in a guidleine study according to OECD 423. Based on CLP for acute toxicity hazard categories, the acute oral toxicity of the test item – Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1), Lot No: 170825 is considered as Category 4; based on OECD Guideline 423, the LD50 cut-off value of the of test item - Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1), Lot No: 170825 is 500 mg/kg body weight. Under the conditions of the acute dermal toxicity study according to OECD 402 the LD50 value of Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1) in Wistar rats was estimated as being greater than 2000 mg/kg body weight in male and female Wistar rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): K1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): K1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3946667b-7187-4795-a536-76a1ef7a534a/documents/37815912-2b6c-42f8-94a0-669fb84c58cb_1ad3095a-4c7f-4e02-b92c-726b3ed45ce7.html,,,,,, "Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1)",68527-63-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3946667b-7187-4795-a536-76a1ef7a534a/documents/37815912-2b6c-42f8-94a0-669fb84c58cb_1ad3095a-4c7f-4e02-b92c-726b3ed45ce7.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "Diethyl sulphate, compound with 2-(heptadec-8-enyl)-4,5-dihydro-1H-imidazole-1-ethanol (1:1)",68527-63-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3946667b-7187-4795-a536-76a1ef7a534a/documents/37815912-2b6c-42f8-94a0-669fb84c58cb_1ad3095a-4c7f-4e02-b92c-726b3ed45ce7.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Diethyl sulphide,352-93-2,"Key read across data were identified to evaluate the acute oral, dermal, and inhalation toxicity potential of diethyl sulphide. The key parameters are discussed below: • Acute oral LD50: >5000 mg/kg bw • Acute dermal LD0: >2000 mg/kg bw• Acute inhalation LC50: 102 mg/L ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8aa1550a-6aad-4cd3-88d8-39df8f247ea7/documents/IUC5-c984de2d-c262-4ca4-8890-4a310b62fa61_f133d6e1-9a14-41cc-b83b-e3392c566cd1.html,,,,,, Diethyl sulphide,352-93-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8aa1550a-6aad-4cd3-88d8-39df8f247ea7/documents/IUC5-c984de2d-c262-4ca4-8890-4a310b62fa61_f133d6e1-9a14-41cc-b83b-e3392c566cd1.html,,oral,LD50,"5,000 mg/kg bw",, Diethyl sulphide,352-93-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8aa1550a-6aad-4cd3-88d8-39df8f247ea7/documents/IUC5-c984de2d-c262-4ca4-8890-4a310b62fa61_f133d6e1-9a14-41cc-b83b-e3392c566cd1.html,,dermal,LD50,"2,000 mg/kg bw",, Diethyl sulphide,352-93-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8aa1550a-6aad-4cd3-88d8-39df8f247ea7/documents/IUC5-c984de2d-c262-4ca4-8890-4a310b62fa61_f133d6e1-9a14-41cc-b83b-e3392c566cd1.html,,inhalation,LC50,"102,000 mg/m3",, Diethylaluminium chloride,96-10-6, The substance is highly pyrophoric and water-reactive and was not testable under the conditions in the CRO glovebox. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0dde9633-3e0a-4edd-ad83-f9a114e1b21b/documents/19fda027-08f6-4df6-b6d1-c66340d33f6f_34f4d22d-a442-467d-ba8e-d7e7998e3f92.html,,,,,, Diethylaluminium chloride,96-10-6, The substance is highly pyrophoric and water-reactive and was not testable under the conditions in the CRO glovebox. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0dde9633-3e0a-4edd-ad83-f9a114e1b21b/documents/fe27631b-e9fa-4f9c-81aa-24b5079e0376_34f4d22d-a442-467d-ba8e-d7e7998e3f92.html,,,,,, Diethylammonium chloride,660-68-4," RA from CAS 75-50-3: NOAEL systemic (oral, subacute, rat, OECD 422) = 40 mg/kg bw/day RA from CAS 109-89-7: NOAEC systemic (inhalation, subchronic, mouse and rat, similar to OECD 413): 16 ppm NOAEC local (inhalation, subchronic, mouse and rat, similar to OECD 413): 16 ppm ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56dd7b22-a6eb-431f-9bd8-da1a62538aca/documents/6abdc4c1-2d66-4377-81ae-008c476c656e_89b3a247-9aa2-42ca-8457-387b4935d45f.html,,,,,, Diethylammonium chloride,660-68-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56dd7b22-a6eb-431f-9bd8-da1a62538aca/documents/6abdc4c1-2d66-4377-81ae-008c476c656e_89b3a247-9aa2-42ca-8457-387b4935d45f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat Diethylammonium chloride,660-68-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56dd7b22-a6eb-431f-9bd8-da1a62538aca/documents/6abdc4c1-2d66-4377-81ae-008c476c656e_89b3a247-9aa2-42ca-8457-387b4935d45f.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,49 mg/m3,,other:rat and mouse Diethylammonium chloride,660-68-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56dd7b22-a6eb-431f-9bd8-da1a62538aca/documents/6abdc4c1-2d66-4377-81ae-008c476c656e_89b3a247-9aa2-42ca-8457-387b4935d45f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,49 mg/m3,adverse effect observed,other:rat and mouse Diethylammonium chloride,660-68-4," There are no data available on acute toxicity properties of diethylammonium chloride (CAS 660-68-4). But acute oral toxicity data with the the structural analogue substance diethylamine (CAS 109-89-7) are available: acute toxicity, oral (similar to OECD 401, RL2), male rats: LD50 = 540 mg/kg bw acute toxicity, inhalation (similar to OECD 403, RL2), female rats: LC50 = 17300 mg/m3 (calculated) acute toxicity, dermal (no guideline followed, RL2), male rabbits: LD50 = 582 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56dd7b22-a6eb-431f-9bd8-da1a62538aca/documents/2a78962d-1746-433f-8ca0-67f0fbd3383a_89b3a247-9aa2-42ca-8457-387b4935d45f.html,,,,,, Diethylammonium chloride,660-68-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56dd7b22-a6eb-431f-9bd8-da1a62538aca/documents/2a78962d-1746-433f-8ca0-67f0fbd3383a_89b3a247-9aa2-42ca-8457-387b4935d45f.html,,oral,LD50,540 mg/kg bw,adverse effect observed, Diethylammonium chloride,660-68-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56dd7b22-a6eb-431f-9bd8-da1a62538aca/documents/2a78962d-1746-433f-8ca0-67f0fbd3383a_89b3a247-9aa2-42ca-8457-387b4935d45f.html,,dermal,LD50,582 mg/kg bw,adverse effect observed, Diethylammonium chloride,660-68-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56dd7b22-a6eb-431f-9bd8-da1a62538aca/documents/2a78962d-1746-433f-8ca0-67f0fbd3383a_89b3a247-9aa2-42ca-8457-387b4935d45f.html,,inhalation,LC50,"25,922 mg/m3",adverse effect observed, Diethylmethylbenzenediamine,68479-98-1,"Numerous repeated dose toxicity studies have been performed in rats, which include the following: one 21-day repeated dermal toxicity study (Hixson 1981), two 28-day dietary studies (Naismith 1986; Bolus 1989), two 90-day dietary studies (Steinhoff and Gunselmann, 1986; Naismith 1987), one chronic gavage study (Steinhoff and Gunselmann, 1986), and two chronic dietary studies (Steinhoff and Gunselmann, 1986; Ciofalo 1992). No systemic toxicity was observed up to the limit dose in the 21-day repeated dermal toxicity study (Hixson 1981). The most consistent endpoint affected in the subchronic and chronic oral toxicity studies was decreased bodyweight. The target organ of toxicity in subchronic and chronic studies was the pancreas. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fb040c5-34e8-4fb2-b648-b2193b992f49/documents/IUC5-415bb4c9-093d-4375-9be0-87099356823e_41252c7f-ed13-4af1-9366-7a02bab1de4c.html,,,,,, Diethylmethylbenzenediamine,68479-98-1,"Oral: LD50 rat = 738 mg/kg bwDermal: LD50 rat/rabbit > 2000 mg/kg bwInhalation: DNEL (inhalation, short-term, systemic effects) = 0.0518 mg/m3 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fb040c5-34e8-4fb2-b648-b2193b992f49/documents/IUC5-a29dcc84-35dd-443b-bb3b-6890715dcb24_41252c7f-ed13-4af1-9366-7a02bab1de4c.html,,,,,, Diethylmethylbenzenediamine,68479-98-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fb040c5-34e8-4fb2-b648-b2193b992f49/documents/IUC5-a29dcc84-35dd-443b-bb3b-6890715dcb24_41252c7f-ed13-4af1-9366-7a02bab1de4c.html,,oral,LD50,738 mg/kg bw,adverse effect observed, Diethylmethylbenzenediamine,68479-98-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fb040c5-34e8-4fb2-b648-b2193b992f49/documents/IUC5-a29dcc84-35dd-443b-bb3b-6890715dcb24_41252c7f-ed13-4af1-9366-7a02bab1de4c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Diethylzinc,557-20-0, The endpoint is waived as the substance is pyrophoric and corrosive ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5925bf98-63fc-42c8-abf4-1e10ef5146f6/documents/a867d121-6765-46a6-a26f-f03115b432ae_0c4feff5-340c-439d-9dbd-3d67f3321a04.html,,,,,, Diethylzinc,557-20-0," Corrosive. Short chain zinc alkyls ignite spontaneously on contact with air and therefore are classified pyrophoric. Reactions of zinc alkyls with liquids (ie. water and alcohols) are in some cases explosion like. Exposure of mammalian species to zinc alkyls would not generate meaningful data, and no acute toxicity studies are required for this substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5925bf98-63fc-42c8-abf4-1e10ef5146f6/documents/IUC5-aac72db0-9e4a-4e8b-a639-15b352d2f98c_0c4feff5-340c-439d-9dbd-3d67f3321a04.html,,,,,, Difluoroacetic acid,381-73-7,"The substance difluoroacetic acid does not exhibit repeated dose toxicity by oral,inhalation and dermal route. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb5bf803-08e1-4432-8141-9d1787875756/documents/IUC5-c105e372-9d42-4ef7-bd90-b24099b615f0_c40770f6-2cfd-46aa-ae6f-e4d123195db3.html,,,,,, Difluoroacetic acid,381-73-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb5bf803-08e1-4432-8141-9d1787875756/documents/IUC5-c105e372-9d42-4ef7-bd90-b24099b615f0_c40770f6-2cfd-46aa-ae6f-e4d123195db3.html,Sub-chronic toxicity – systemic effects,oral,,95.09 mg/kg bw/day,,mouse Difluoroacetic acid,381-73-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb5bf803-08e1-4432-8141-9d1787875756/documents/IUC5-c105e372-9d42-4ef7-bd90-b24099b615f0_c40770f6-2cfd-46aa-ae6f-e4d123195db3.html,Sub-chronic toxicity – systemic effects,inhalation,,179.551 mg/m3,,rat Difluoroacetic acid,381-73-7,Based on the end point values it can be confirmed that the target chemical will be non toxic to animals ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb5bf803-08e1-4432-8141-9d1787875756/documents/IUC5-dcd61c81-ef77-4a99-8bb8-ff8f2013ccf7_c40770f6-2cfd-46aa-ae6f-e4d123195db3.html,,,,,, Difluoroacetic acid,381-73-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb5bf803-08e1-4432-8141-9d1787875756/documents/IUC5-dcd61c81-ef77-4a99-8bb8-ff8f2013ccf7_c40770f6-2cfd-46aa-ae6f-e4d123195db3.html,,oral,LD50,"6,957.5 mg/kg bw",no adverse effect observed, Difluoroacetic acid,381-73-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb5bf803-08e1-4432-8141-9d1787875756/documents/IUC5-dcd61c81-ef77-4a99-8bb8-ff8f2013ccf7_c40770f6-2cfd-46aa-ae6f-e4d123195db3.html,,dermal,LD50,"5,717.285 mg/kg bw",no adverse effect observed, Difluoroacetic acid,381-73-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb5bf803-08e1-4432-8141-9d1787875756/documents/IUC5-dcd61c81-ef77-4a99-8bb8-ff8f2013ccf7_c40770f6-2cfd-46aa-ae6f-e4d123195db3.html,,inhalation,LC50,28.598 mg/m3,no adverse effect observed, Difluoromethane,75-10-5, The NOAEL for repeated dose toxicity is higher than about 105000 mg/m3 (50000 ppm v/v) in rats (highest tested concentration) exposed for a period of 90 days. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5b20ec4-8161-48c0-bd23-7af015db123a/documents/IUC5-0b5bc863-8c0a-474c-8313-765a0cb4af7e_6226dd87-afc5-4f3f-ac05-87194724a494.html,,,,,, Difluoromethane,75-10-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5b20ec4-8161-48c0-bd23-7af015db123a/documents/IUC5-0b5bc863-8c0a-474c-8313-765a0cb4af7e_6226dd87-afc5-4f3f-ac05-87194724a494.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"105,000 mg/m3",,rat Difluoromethane,75-10-5, Acute inhalation toxicity of difluoromethane is very low with no mortality or other significant effects in rats after 4 hours exposure up to 520000 ppm (1107000 mg/m3). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5b20ec4-8161-48c0-bd23-7af015db123a/documents/IUC5-537a44cd-c11a-4955-9131-2273489b2f7f_6226dd87-afc5-4f3f-ac05-87194724a494.html,,,,,, Difluoromethane,75-10-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5b20ec4-8161-48c0-bd23-7af015db123a/documents/IUC5-537a44cd-c11a-4955-9131-2273489b2f7f_6226dd87-afc5-4f3f-ac05-87194724a494.html,,inhalation,LC50,"1,107,000 mg/m3",no adverse effect observed, Digadolinium trioxide,12064-62-9," Repeated dose toxicity - oral The key study (Papineau, 2017) was performed according to OECD guideline 422 and conform GLP requirements. In this study, gadolinium oxide was administered by oral gavage to male and female Sprague-Dawley rats, starting 2 weeks before mating, during mating and (for females) throughout gestation and until day 5 post-partum, at the dose levels of 110, 330 or 1200 (until day 17 of the study)/1008 (from day 18 of the study until end of exposure) mg/kg bw/day. In this study, the NOAEL for parental systemic toxicity was considered to be higher than or equal to 1008 mg/kg bw/day based on the absence of adverse findings related to the test item at the highest dose level. Based on these results, the test substance is not classified as STOT RE. Repeated dose toxicity - inhalation/dermal No key studies were identified for repeated dose toxicity after inhalation or dermal exposure. A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (Column 2, Annex VIII, Section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation or dermal route of exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/68ac7733-772d-41d0-bc95-fd3de38ca731/documents/dc3d2442-d15b-430d-93a9-7ddb0b88494b_9fb6e337-c21d-4941-8e4e-fb5a3f2dd56a.html,,,,,, Digadolinium trioxide,12064-62-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/68ac7733-772d-41d0-bc95-fd3de38ca731/documents/dc3d2442-d15b-430d-93a9-7ddb0b88494b_9fb6e337-c21d-4941-8e4e-fb5a3f2dd56a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,008 mg/kg bw/day",,rat Digadolinium trioxide,12064-62-9," Acute oral toxicity Two reliable acute toxicity studies via the oral route of administration are available. After single dosing of 2000 mg/kg to rats, the LD50 was established as greater than 2000 mg/kg bw (Clouzeau, 1994). In a second study, the single dose acute oral LD50 was established as greater than 5000 mg/kg bw when administered as a 50% w/w solution with distilled water (Shapiro, 1990a). Based on these results, the test substance is considered not classified as acute oral toxicant. Acute toxicity via inhalation In a reliable acute inhalation toxicity study performed according to OECD guideline 436, no deaths occurred in a group of 6 rats exposed to the concentration of 5.04 mg/L for 4 hours (Tóth, 2016). The 4-h LC50 was therefore considered greater than 5.04 mg/L and the substance is thus not classified as acute toxicant via inhalation. Acute dermal toxicity The acute oral LD50 is greater than 2000 mg/kg bw and no systemic effects or macroscopic abnormalities were observed in the reliable studies available for this endpoint. According to Annex VIII, column 2 of the REACH Regulation (revision May 2016), acute dermal toxicity can be waived if the substance under consideration is not classified as acute oral toxicant or as STOT SE, and no systemic effects have been observed in in vivo studies with dermal exposure. The latter criterion (in vivo skin irritation study) is also fulfilled. Moreover, in addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For gadolinium oxide, a key study is available for the inhalatory route of exposure. Therefore, an acute dermal toxicity study should not be performed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68ac7733-772d-41d0-bc95-fd3de38ca731/documents/c69d78ba-c2ed-42f9-ac36-925c795b8761_9fb6e337-c21d-4941-8e4e-fb5a3f2dd56a.html,,,,,, Dihexadecyl peroxodicarbonate,26322-14-5, Oral NOAEL is 1000 mg/kg bw/day based on the outcome of the OECD 408 study with the read-across substance. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4340a285-100c-456b-bf91-8b65e254fb16/documents/IUC5-30c260b2-fcfe-44c3-aeee-e062dee02cc0_865e9555-1c7a-479c-805d-25a03bcf6ec9.html,,,,,, Dihexadecyl peroxodicarbonate,26322-14-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4340a285-100c-456b-bf91-8b65e254fb16/documents/IUC5-30c260b2-fcfe-44c3-aeee-e062dee02cc0_865e9555-1c7a-479c-805d-25a03bcf6ec9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dihexadecyl peroxodicarbonate,26322-14-5, The oral LD50 is > 5000 mg/kg bw. No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. There are no studies available for the inhalationl or the dermal route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4340a285-100c-456b-bf91-8b65e254fb16/documents/IUC5-b9a1a28c-a31b-4f2b-9211-cebc1d8c22a8_865e9555-1c7a-479c-805d-25a03bcf6ec9.html,,,,,, Dihexyl ether,112-58-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e71729d-559a-44ba-8593-f9442c7f94e4/documents/IUC5-6b72ae7b-c199-4a63-ba89-6d56f9010e69_d9ed837c-6ae1-4540-b5c0-ac11c2effd2c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat Dihexyl ether,112-58-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e71729d-559a-44ba-8593-f9442c7f94e4/documents/IUC5-9d7d6b85-7798-4648-9e0a-e7ccc19ba25d_d9ed837c-6ae1-4540-b5c0-ac11c2effd2c.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Dihexyl ether,112-58-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e71729d-559a-44ba-8593-f9442c7f94e4/documents/IUC5-9d7d6b85-7798-4648-9e0a-e7ccc19ba25d_d9ed837c-6ae1-4540-b5c0-ac11c2effd2c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Dihexyl ether,112-58-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e71729d-559a-44ba-8593-f9442c7f94e4/documents/IUC5-9d7d6b85-7798-4648-9e0a-e7ccc19ba25d_d9ed837c-6ae1-4540-b5c0-ac11c2effd2c.html,,inhalation,discriminating conc.,5.13 ,no adverse effect observed, "Dihydro-2,2-dioctyl-6H-1,3,2-oxathiastannin-6-one",3033-29-2," By read-across to Dioctyltin oxide, target organ of Dioctyltin mercaptopropionate is considered to be the thymus. Due to studies on Dioctyltin dichloride, the thymus toxicity of dioctyltins is judged an acute effect. Read-across to structurally similar substance: DOTO (Dioctyltin oxide) Under the conditions of this study, based on the effects noted in the thymus in both male and female rats in the 25 mg/kg diet groups, the NOAEL was concluded to be the lowest group tested, 5 mg/kg diet which was equivalent to 0.3-0.4 mg/kg bw/day for male animals and 0.3-0.5 mg/kg bw/day for female animals. After correction for molecular weight, the NOAEL values from read-across to Dioctyltin oxide were, 0.4 -0.5 mg/kg bw/day for male animals and 0.4-0.6 mg/kg bw/day for female animals. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/377abb6a-64c8-4477-8dd7-065bb7738c47/documents/6d78c873-e878-4d4f-a13f-3b3c41d079bb_db14e351-9876-4be4-bf5d-aec928ca81b5.html,,,,,, "Dihydro-2,2-dioctyl-6H-1,3,2-oxathiastannin-6-one",3033-29-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/377abb6a-64c8-4477-8dd7-065bb7738c47/documents/6d78c873-e878-4d4f-a13f-3b3c41d079bb_db14e351-9876-4be4-bf5d-aec928ca81b5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,0.4 mg/kg bw/day,,rat "Dihydro-2,2-dioctyl-6H-1,3,2-oxathiastannin-6-one",3033-29-2," Oral Under the conditions of a OECD 401 and EU Method B.1 guideline study, the oral LD50 value for Dioctyltin mercaptopropionate in Sprague-Dawley rats was established to exceed 2000 mg/kg body weight. Dermal By read-across to Dioctyltin oxide, the dermal LD50 of Dioctyltin mercaptopropionate, corrected for molecular weight, is considered to be greater than 2488 mg/kg bodyweight. Dermal: Read-across to structurally similar substance: DOTO (Dioctyltin oxide) The acute dermal median lethal dose (LD50) of DOTO determined in a OECD 402 and EU Method B.1 guideline study in the Wistar strain of rat was determined to be greater than 2000 mg/kg bodyweight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/377abb6a-64c8-4477-8dd7-065bb7738c47/documents/502ca1a4-7db8-4940-b5bb-6c09f7c709e9_db14e351-9876-4be4-bf5d-aec928ca81b5.html,,,,,, "Dihydro-2,2-dioctyl-6H-1,3,2-oxathiastannin-6-one",3033-29-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/377abb6a-64c8-4477-8dd7-065bb7738c47/documents/502ca1a4-7db8-4940-b5bb-6c09f7c709e9_db14e351-9876-4be4-bf5d-aec928ca81b5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Dihydro-2,2-dioctyl-6H-1,3,2-oxathiastannin-6-one",3033-29-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/377abb6a-64c8-4477-8dd7-065bb7738c47/documents/502ca1a4-7db8-4940-b5bb-6c09f7c709e9_db14e351-9876-4be4-bf5d-aec928ca81b5.html,,dermal,LD50,"2,488 mg/kg bw",no adverse effect observed, "Dihydro-3-(tetrapropenyl)furan-2,5-dione",26544-38-7,"NOAEL for a 28-day repeated dose study of a chemical category member, TSA, was 50 mg/kg bw/d. chronic toxicity data according to OECD 408 will be submitted later  based on ECHA decision number CCH-D-2114575506-41-01/F             ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1851c746-5d43-4ab9-825f-2ce05d3d9f7e/documents/IUC5-3797f62e-05ba-4afb-af7c-9a2dae3a0f13_ea920838-d65e-4bbf-a718-5471306d524c.html,,,,,, "Dihydro-3-(tetrapropenyl)furan-2,5-dione",26544-38-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1851c746-5d43-4ab9-825f-2ce05d3d9f7e/documents/IUC5-3797f62e-05ba-4afb-af7c-9a2dae3a0f13_ea920838-d65e-4bbf-a718-5471306d524c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Dihydro-3-(tetrapropenyl)furan-2,5-dione",26544-38-7,"The oral LD50 in rats was 2.9 g/kg, and the dermal LD100 was > 6.2 g/kg in rabbits. The dermal LD50 is less than 6.2 g/kg, and is estimated to be > 2.0 g/kg. An acute inhalation toxicity study, LC50 > 5.3 mg/L, is read-across from a category member, nDDSA. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1851c746-5d43-4ab9-825f-2ce05d3d9f7e/documents/IUC5-53fc41cb-7310-4240-928b-8528a9b2c2ca_ea920838-d65e-4bbf-a718-5471306d524c.html,,,,,, "Dihydro-3-(tetrapropenyl)furan-2,5-dione",26544-38-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1851c746-5d43-4ab9-825f-2ce05d3d9f7e/documents/IUC5-53fc41cb-7310-4240-928b-8528a9b2c2ca_ea920838-d65e-4bbf-a718-5471306d524c.html,,oral,LD50,"2,900 mg/kg bw",adverse effect observed, "Dihydro-3-(tetrapropenyl)furan-2,5-dione",26544-38-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1851c746-5d43-4ab9-825f-2ce05d3d9f7e/documents/IUC5-53fc41cb-7310-4240-928b-8528a9b2c2ca_ea920838-d65e-4bbf-a718-5471306d524c.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "Dihydro-3-(tetrapropenyl)furan-2,5-dione",26544-38-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1851c746-5d43-4ab9-825f-2ce05d3d9f7e/documents/IUC5-53fc41cb-7310-4240-928b-8528a9b2c2ca_ea920838-d65e-4bbf-a718-5471306d524c.html,,inhalation,LC50,"5,300 mg/m3",no adverse effect observed, "Dihydro-3-(tripropenyl)furan-2,5-dione",92077-08-2,"OECD 407 Study (28-day repeated dose toxicity, oral): NOAEL= 50 mg/kg bw/d ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/189ad6a2-a380-45d9-90f4-7ff6bc3397b0/documents/IUC5-985ec174-4a17-445e-853e-e41018d056fe_d519ff45-2dd2-4765-a840-72f13286e867.html,,,,,, "Dihydro-3-(tripropenyl)furan-2,5-dione",92077-08-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/189ad6a2-a380-45d9-90f4-7ff6bc3397b0/documents/IUC5-985ec174-4a17-445e-853e-e41018d056fe_d519ff45-2dd2-4765-a840-72f13286e867.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Dihydro-3-(tripropenyl)furan-2,5-dione",92077-08-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable and robust; study equicalent to guidline Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Reliable and robust; GLP guideline study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/189ad6a2-a380-45d9-90f4-7ff6bc3397b0/documents/IUC5-62f80dc8-d1cc-445b-8051-3c5da28f53e1_d519ff45-2dd2-4765-a840-72f13286e867.html,,,,,, "Dihydro-3-(tripropenyl)furan-2,5-dione",92077-08-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/189ad6a2-a380-45d9-90f4-7ff6bc3397b0/documents/IUC5-62f80dc8-d1cc-445b-8051-3c5da28f53e1_d519ff45-2dd2-4765-a840-72f13286e867.html,,oral,discriminating dose,"1,000 mg/kg bw",adverse effect observed, "Dihydro-3-[3-(triethoxysilyl)propyl]furan-2,5-dione",93642-68-3,"The key study for acute oral toxicity reports an LD50 of >2000 mg/kg bw, in a reliable study conducted according to OECD TG 401 and in compliance with GLP (Hoechst, 1998). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/191bbfc7-0ca8-4112-b74e-3cad498e0651/documents/IUC5-045f38ed-b322-40d9-9c70-dd3bd36bf48e_8bb73bbc-14cb-4c23-a1e7-628a7dfa7acb.html,,,,,, "Dihydro-3-[3-(triethoxysilyl)propyl]furan-2,5-dione",93642-68-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/191bbfc7-0ca8-4112-b74e-3cad498e0651/documents/IUC5-045f38ed-b322-40d9-9c70-dd3bd36bf48e_8bb73bbc-14cb-4c23-a1e7-628a7dfa7acb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Dihydrogen [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']nickelate(2-)",25481-21-4,"Repeated dose toxicity: Oral Based on the data available from different studies, the No Observed Adverse Effect Level (NOAEL) for test material was considered to be 500 mg/kg/day for repeated dose oral toxicity study, when rodents were treated with test material orally by gavage.   Repeated dose toxicity: Dermal A short-term toxicity study does not need to be conducted because exposure of humans via dermal in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment.    Repeated dose toxicity: Inhalation A short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment.  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): waiver Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): waiver Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Data is klimisch 2. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70521d47-6453-4fa5-9952-c000fc8ebe10/documents/ee00aa7a-0242-4331-ada4-f7e00f39bdcf_84b9c9e9-d284-42b5-8152-29cf9e75a3cc.html,,,,,, "Dihydrogen [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']nickelate(2-)",25481-21-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70521d47-6453-4fa5-9952-c000fc8ebe10/documents/ee00aa7a-0242-4331-ada4-f7e00f39bdcf_84b9c9e9-d284-42b5-8152-29cf9e75a3cc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Dihydrogen [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']nickelate(2-)",25481-21-4,"Acute oral toxicity : Based on the data published it was concluded that, the lethal concentration (LD50) value for acute oral toxicity test was considered to be 10000 mg/kg bw. Acute Inhalation Toxicity : Waiver Acute  Dermal Toxicity: The acute dermal toxicity in rats was noted to be >2000 mg/kg bw, as there were no mortalities observed in any of the animals. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Data is Klimisch 2 and from authoritative database Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Waiver ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70521d47-6453-4fa5-9952-c000fc8ebe10/documents/978a1a4f-8a77-4995-b13f-761ee0e20e5a_84b9c9e9-d284-42b5-8152-29cf9e75a3cc.html,,,,,, "Dihydrogen [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']nickelate(2-)",25481-21-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70521d47-6453-4fa5-9952-c000fc8ebe10/documents/978a1a4f-8a77-4995-b13f-761ee0e20e5a_84b9c9e9-d284-42b5-8152-29cf9e75a3cc.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Dihydrogen [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']nickelate(2-)",25481-21-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70521d47-6453-4fa5-9952-c000fc8ebe10/documents/978a1a4f-8a77-4995-b13f-761ee0e20e5a_84b9c9e9-d284-42b5-8152-29cf9e75a3cc.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Dihydrogen [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)",52953-39-6," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target substance Dihydrogen [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)(52953-39-6) was estimated to be 4747.09 mg/kg bw,and for different studies available structurally similar read across substance (4Z)-4-[(1-hydroxynaphthalen-2-yl)hydrazinylidene]-7-nitro-3-oxonaphthalene-1-sulfonic acid (1787-61-7) was considered to be 17590 mg/kg bw for rats and for functionally similar read across substance Disodium hydrogen bis[5-chloro-3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxybenzenesulphonato(3-)]chromate(3-) (6408-26-0)was considered to be >15000 mg/kg bw for rats.All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,Dihydrogen [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)(52953-39-6) cannot be classified for acute oral toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7b122c5-68f8-47b0-900f-f80eb80dc6a7/documents/b5b6f6de-0d8f-4afc-bd2e-3cfb5c5e3659_bef251f6-552d-4e07-8cd7-7e1fa7b5c511.html,,,,,, "Dihydrogen [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)",52953-39-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7b122c5-68f8-47b0-900f-f80eb80dc6a7/documents/b5b6f6de-0d8f-4afc-bd2e-3cfb5c5e3659_bef251f6-552d-4e07-8cd7-7e1fa7b5c511.html,,oral,LD50,"4,747.09 mg/kg bw",no adverse effect observed, "Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)",78948-87-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8eb46722-b2f4-4535-8134-af5eea1f1c32/documents/ead77e9a-1212-4ab0-a8b7-0ea60c25b231_db315318-a798-48f3-b668-782ed659deb6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,124 mg/kg bw/day,,rat "Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)",78948-87-5," The acute oral toxicity of H 48 bleach was 2262 mg/kg bw. in the combined sex (2201 mg/kg in males, 2357 mg/kg in females). According to CLP GHS, H 48 bleach requires no classification, as the acute oral LD50 was >2000 mg/kg of body weight. The acute dermal toxicity of H 48 bleach was >2000 mg/kg bw. in the combined sex. The LD50 is > 2000 mg/kg bw. In an acute inhalationstudy the acute median lethal concentration for H48 bleach (LC50, 4 hours) was 1.72 mg/L of air for the combined sex (1.97 mg/L for males, 1.57 mg/L for females). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8eb46722-b2f4-4535-8134-af5eea1f1c32/documents/a308e938-7b4a-403f-a4e6-1019a08432f3_db315318-a798-48f3-b668-782ed659deb6.html,,,,,, "Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)",78948-87-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8eb46722-b2f4-4535-8134-af5eea1f1c32/documents/a308e938-7b4a-403f-a4e6-1019a08432f3_db315318-a798-48f3-b668-782ed659deb6.html,,oral,LD50,"2,262 mg/kg bw",no adverse effect observed, "Dihydrogen bis[monoperoxyphthalato(2-)-O1,OO1]magnesate(2-)",78948-87-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8eb46722-b2f4-4535-8134-af5eea1f1c32/documents/a308e938-7b4a-403f-a4e6-1019a08432f3_db315318-a798-48f3-b668-782ed659deb6.html,,inhalation,LC50,"1,720 mg/m3",adverse effect observed, Dihydrogen hexafluorotitanate(2-),17439-11-1,"Read-across from the salt K2TiF6 to the acid H2TiF6 (see read-across statement in section 13.2): OECD 408, GLP, rat feeding: Under the conditions of this study and based on the toxicological endpoints evaluated, a no-observed-adverse-effect level (NOAEL) was not reached in males or females for DiPotassium hexafluorotitanate (IV) – 01727.  Microscopic findings that were considered adverse, consisting of degenerative nephropathy, ameloblast degeneration, and necrosis, dentin alteration, parathyroid gland hyperplasia, decreased bone, fibrous osteodystrophy, and reproductive organ atrophy were present in both sexes at the lowest dietary level, 250 ppm. Based on target nominal concentrations, intakes of 12.5, 25.6, and 45.9 mg/kg/day in male rats, and 17.0, 32.9, and 61.8 mg/kg/day in female rats were calculated for Groups 2-4, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6a17140-e8a4-4788-b38d-b3201fb6874d/documents/IUC5-3c1da4e3-57ea-4abe-ad77-ec0def37007c_f6ea1854-c066-43fb-8657-89510d897028.html,,,,,, Dihydrogen hexafluorotitanate(2-),17439-11-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6a17140-e8a4-4788-b38d-b3201fb6874d/documents/IUC5-3c1da4e3-57ea-4abe-ad77-ec0def37007c_f6ea1854-c066-43fb-8657-89510d897028.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,12.5 mg/kg bw/day,,rat Dihydrogen hexafluorotitanate(2-),17439-11-1," Because the substance H2TiF6 is a highly corrosive liquid (Skin Corr. 1, H314: Causes severe skin burns and eye damage), no experimental studies investigating acute oral, dermal or inhalation toxicity are available. By way of expert judgement, taking into consideration the corrosivity and the degree of acute toxicity of other inorganic fluorides, specifically of hydrofluoric acid, which is an impurity in H2TiF6, H2TiF6 is classified as follows: Acute Tox 3, with the hazard statements H301: Toxic of swallowed, H311 Toxic in contact with skin, and H331 Toxic if inhaled. This classification is equivalent to the classification of a 1-7% solution of hydrofluorid acid. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6a17140-e8a4-4788-b38d-b3201fb6874d/documents/IUC5-188895ee-a5c3-437f-8188-ee8fded69c33_f6ea1854-c066-43fb-8657-89510d897028.html,,,,,, Dihydrogen hexafluorozirconate(2-),12021-95-3,"In rodents, repeated exposure to fluoride salts, such as sodium fluoride, causes alteration of teeth at daily doses of 4 mg NaF/kg bw/day or greater. Higher repeated doses of 10 and 25 mg NaF/kg bw/day increase dental effects as well as cause toxic effects in bone and the stomach. The severity of the toxic effects is related to increasing dose and duration of exposure. In a life-time chronic exposure study in the rats, an extremely high concentration of 175 ppm sodium fluoride in drinking water was associated with an increased incidence of osteosclerosis in female rats and equivocal evidence of osteosarcoma in male rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2a9d23d-8fe4-45b0-8ac1-13ab38a5f6a6/documents/IUC5-ebde9349-428b-4d45-8399-d0d0e69abf1b_5373cee9-5df1-4ec9-a9e1-ec9df848ec02.html,,,,,, Dihydrogen hexafluorozirconate(2-),12021-95-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2a9d23d-8fe4-45b0-8ac1-13ab38a5f6a6/documents/IUC5-ebde9349-428b-4d45-8399-d0d0e69abf1b_5373cee9-5df1-4ec9-a9e1-ec9df848ec02.html,Chronic toxicity – systemic effects,oral,LOAEL,8.2 mg/kg bw/day,,rat Dihydrogen hexafluorozirconate(2-),12021-95-3,"Because the substance H2ZrF6 is a highly corrosive liquid (Skin Corr. 1A, H314: Causes severe skin burns and eye damage), no experimental studies investigating acute oral, dermal or inhalation toxicity are available. By way of expert judgement, taking into consideration the corrosivity and the degree of acute toxicity of other inorganic fluorides, specifically of hydrofluoric acid, which is an impurity in H2ZrF6, H2ZrF6 is classified as follows: Acute Tox 3, with the hazard statements H301: Toxic of swallowed, H311 Toxic in contact with skin, and H331 Toxic if inhaled. This classification is equivalent to the classification of a 1-7% solution of hydrofluorid acid. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2a9d23d-8fe4-45b0-8ac1-13ab38a5f6a6/documents/IUC5-403e240c-3377-4120-b218-cd8daa63ba64_5373cee9-5df1-4ec9-a9e1-ec9df848ec02.html,,,,,, Dihydrogen hexahydroxyplatinate,51850-20-5," In an OECD Test Guideline 422 combined repeated dose and reproductive/developmental toxicity screening study in rats, involving the gavage administration of dihydrogen hexahydroxyplatinate for at least 35 days, no clinical signs of toxicity or any adverse pathological or histopathological effects were observed. The study NOAEL was the highest tested dose (1000 mg/kg bw/day) (Hansen, 2015).   No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb118031-a378-4830-b5c1-7b3bcc0f9524/documents/fd02f4e0-d69e-4b1d-bf2c-69d2b5d236d1_e6958062-c0be-46a7-b2c6-c9024ea26f8a.html,,,,,, Dihydrogen hexahydroxyplatinate,51850-20-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb118031-a378-4830-b5c1-7b3bcc0f9524/documents/fd02f4e0-d69e-4b1d-bf2c-69d2b5d236d1_e6958062-c0be-46a7-b2c6-c9024ea26f8a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dihydrogen hexahydroxyplatinate,51850-20-5," In a guideline GLP study, the acute oral LD50 value of hexahydroxoplatinum(IV) acid was determined to exceed 2150 mg/kg bw (limit test) in rats (Berthold, 1995a).   No relevant acute dermal or inhalation toxicity data were identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb118031-a378-4830-b5c1-7b3bcc0f9524/documents/1ddc8b16-d7c2-4685-bd9e-da6a0305a88b_e6958062-c0be-46a7-b2c6-c9024ea26f8a.html,,,,,, "Dihydrogen hexahydroxyplatinate, compound with 2-aminoethanol (1:2)",68133-90-4," In an OECD Test Guideline 422 combined repeated dose and reproduction/developmental toxicity screening study in rats, conducted to GLP, dihydrogen hexahydroxyplatinate, compound with 2-aminoethanol, was administered by gavage for at least 28 days at doses of 0, 100, 300 or 1000 mg/kg bw/day. Control animals received vehicle only. Treatment-related adverse effects were observed in the high dose animals (including reduced motility, decreased food consumption and body weight). The NOAEL for systemic toxicity was established as 300 mg/kg bw/day (Hansen, 2017).   No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ff74d9d-59b1-41b6-aaf8-8962cf7f77f5/documents/c8489724-ef9a-4bea-aee6-baa795151e5f_b7f44cbf-46d3-4325-b63d-8810419a0d1f.html,,,,,, "Dihydrogen hexahydroxyplatinate, compound with 2-aminoethanol (1:2)",68133-90-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ff74d9d-59b1-41b6-aaf8-8962cf7f77f5/documents/c8489724-ef9a-4bea-aee6-baa795151e5f_b7f44cbf-46d3-4325-b63d-8810419a0d1f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Dihydrogen hexahydroxyplatinate, compound with 2-aminoethanol (1:2)",68133-90-4," In an OECD Test Guideline 423 study, to GLP, the acute oral LD50 value of dihydrogen hexahydroxyplatinate compound with 2-aminoethanol (1:2) was determined to exceed 2000 mg/kg bw following gavage administration in rats (Antonelli, 2001).   No relevant acute dermal or inhalation toxicity data were identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ff74d9d-59b1-41b6-aaf8-8962cf7f77f5/documents/3afa4ea0-558d-4487-be96-660f48217dc4_b7f44cbf-46d3-4325-b63d-8810419a0d1f.html,,,,,, Dihydrogen tetrachloropalladate(2-),16970-55-1,"No Repeated dose toxicity data are available for dihydrogen tetrachloropalladate. A GLP-compliant study according to OECD N°422 was performed to obtain information on the possible toxic effects of disodium tetrachloropalladate following repeated (daily) administration at a constant concentration in pelleted diet to Wistar (Crl:WI) rats at 3 dose levels (1000, 3000 and 10000 ppm test item in diet). A control group received non-treated control diet. Under the conditions of this study, the dietary administration of disodium tetrachloropalladate to Wistar rats did not result in test item related mortality. The NOAEL for systemic toxicity of the parental generation was considered to be 3000 ppm (corresponding to 272 mg/kg bw/day) based on effects on body weight, body weight gain and food consumption at 10000 ppm. As supporting evident, the Moore et al (1975) study can be considered. The effect of K2PdCl4 was assessed in a non-guideline study during a 33-day exposure of male rats (10/group) to 92 and 184 ppm test item in drinking water. The study reports no abnormalities in general appearance, body weight and urinalysis. Although limited in experimental setup, this study can be used as supportive evidence for the generic observation of limited adverse systemic effects after repeated oral admistration of tetrachloropalladate substances. Dihydrogen tetrachloropalladate, dipotassium tetrachloropalladate and disodium tetrachloropalladate are member of the group of 'tetrachloropalladate' substances, and a read-across between both substances for this endpoint is considered justified. Considering molecular weight conversion, the NOAEL for systemic toxicity of the parental generation is 272 mg/kg bw/day disodium tetrachloropalladate or 231 mg/kg bw/d dihydrogen tetrachloropalladate using molecular weight conversion, using the evidence from the relevant and reliable Szaloki (2022) study. No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Overall, good-quality database which meets REACH Standard Information Requirements. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/901ed9e5-a899-48aa-a907-831b4ca27afd/documents/448fc83f-ec81-45f4-9fc5-acb25fab6f81_573b737c-aa33-4dc0-bee6-b6c83c8ed986.html,,,,,, Dihydrogen tetrachloropalladate(2-),16970-55-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/901ed9e5-a899-48aa-a907-831b4ca27afd/documents/448fc83f-ec81-45f4-9fc5-acb25fab6f81_573b737c-aa33-4dc0-bee6-b6c83c8ed986.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,231 mg/kg bw/day,,rat Dihydrogen tetrachloropalladate(2-),16970-55-1,"In an OECD Test Guideline 423 study, to GLP, the acute oral LD50 value of dihydrogen tetrachloropalladate (solution) was determined to range between 200 and 2000 mg/kg bw following gavage administration in rats (van Huygevoort, 2003a). No relevant acute dermal or inhalation toxicity data were identified. However, acute toxicity testing by a second route is not considered appropriate as dihydrogen tetrachloropalladate is considered corrosive to the skin. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Overall, good-quality database which meets REACH Standard Information Requirements. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/901ed9e5-a899-48aa-a907-831b4ca27afd/documents/IUC5-4df49131-1688-4b7b-8816-46db8ac91094_573b737c-aa33-4dc0-bee6-b6c83c8ed986.html,,,,,, Dihydrogen tetrachloropalladate(2-),16970-55-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/901ed9e5-a899-48aa-a907-831b4ca27afd/documents/IUC5-4df49131-1688-4b7b-8816-46db8ac91094_573b737c-aa33-4dc0-bee6-b6c83c8ed986.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, Dihydrogen wolframate,7783-03-1," Repeated Dose Toxicity - Oral Route: No oral repeated dose toxicity data of sufficient quality are available for tungstic acid (target substance). However, repeated oral dose toxicity data are available for sodium tungstate (source substance), which will be used for read-across. Due to lower water solubility and lower toxicity for the target substance compared to the source substance, the resulting read-across from the source substance to the target substance is appropriate as a conservative estimate of potential toxicity for this endpoint. In addition, read-across is appropriate because the classification and labelling is more protective for the source substance than the target substance, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, lower for the source substance. For more details, refer to the read-across category approach included in the Category section of this IUCLID submission and/or as an Annex in the CSR. The read-across study on sodium tungstate was sponsored conducted the United States Army Center for Health Promotion and Preventive Medicine and published byMcCain et al (2015). The 90-day oral toxicity study was conducted in rats according to the procedure described in the Environmental Protection Agency (EPA) Health Effects Testing Guidelines (40 CFR, Part 798.2650) in compliance with Good Laboratory Practice. Briefly, this study of the subchronic toxicity of sodium tungstate dihydrate aqueous solution in male and female Sprague-Dawley rats was evaluated by daily oral gavage of 0, 10, 75, 125, or 200 mg/kg bw/d for 90 days. Measured parameters included food consumption, body weight measurements, hematology, clinical chemistry, and histopathological changes. There was a significant decrease in food consumption and body weight gain in males at 200 mg/kg bw/d from days 77 to 90; however, there was no effect in food consumption and body weights in females. There were no changes in the hematological and clinical parameters studied. Histopathological changes were seen in kidney of male and female and epididymis of male rats. The histopathological changes observed in the kidneys of male and female rats dosed at 125 or 200 mg/k/d consisting of mild to severe cortical tubule basophilia in 2 high-dose groups. Histological changes in epididymides included intraluminal hypospermia with cell debris in the 200 mg/kg bw/day dosed male rats. Histopathological changes were observed in the glandular stomach including inflammation and metaplasia in the high-dose groups (125 or 200 mg/kg bw/day) of both sexes of rats. Based on histopathology effects seen in the kidneys, the lowest observable adverse effect level was 125 mg/kg bw/d and the no observable adverse effect level was 75 mg/kg bw/d in both sexes of rats for oral subchronic toxicity. The USEPA’s Benchmark Dose Software (BMDS, Version 1.4.1) was used to model the data to derive a BMDL10. The lowest (most precautionary) BMDL10 from the renal toxicity endpoint in the 90-day oral toxicity study was 102 mg/kg bw/d. In addition to McCain et al (2015) rat oral 90-day repeated dose study, the US National Toxicology Program (NTP) has conducted two additional 90-day drinking water studies, one in Sprague-Dawley rats and a second one in B6C3F1 mice (10/sex/species/dose). The study design included doses of0, 125, 250, 500, 1000, or 2000 mg/L. The in-life study phase has been completed but no study report has yet been issued. Currently, available in the US NTP website are graphs and Tables are preliminary results, but no full report has been issued. Furthermore, at the 2012 Annual Meeting of the Society of Toxicology, a Scientific Poster was presented detailing preliminary results of the NTP study. Preliminary results confirm the results of the McCain gavage study, showing the kidney as the major target organ for tungstate (especially at high drinking water doses of 1,000 and 2,000 mg/L). The US NTP’s Sodium Tungstate Dihydrate final study reports may be available in 2022. Repeated Dose Toxicity - Inhalation Route: No inhalation repeated dose toxicity data of sufficient quality were available for tungstic acid; however, data were available for tungsten oxide (also known as tungsten blue oxide or TBO), which are used for read-across. A 28-day inhalation toxicity study conducted according to OECD 412 is available on tungsten blue oxide, which is considered the key repeated dose study. In this study, 5 rats/sex/dose were given TBO nose-only for 6 hours per day, 7 days/week, for 28 days (with a 14-day recovery period) at doses of 0 (control), 0.08, 0.325, and 0.65 mg/L air. The NOAEC was deemed to be > 0.65 mg/L air (650 mg/m3), as no significant effects were reported. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/28ca3574-d7a5-48db-a50c-5a0ced5e077b/documents/0656eaf4-f8c5-4fbd-8d2e-8f3ec2fed013_9c7272f4-84ac-4c9d-896d-7d6874745636.html,,,,,, Dihydrogen wolframate,7783-03-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/28ca3574-d7a5-48db-a50c-5a0ced5e077b/documents/0656eaf4-f8c5-4fbd-8d2e-8f3ec2fed013_9c7272f4-84ac-4c9d-896d-7d6874745636.html,Sub-chronic toxicity – systemic effects,oral,BMDL10,102 mg/kg bw/day,,rat Dihydrogen wolframate,7783-03-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/28ca3574-d7a5-48db-a50c-5a0ced5e077b/documents/0656eaf4-f8c5-4fbd-8d2e-8f3ec2fed013_9c7272f4-84ac-4c9d-896d-7d6874745636.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,650 mg/m3,,rat Dihydrogen wolframate,7783-03-1," No acute toxicity data are available for tungstic acid; however, data are available for WO3 and sodium tungstate, which were used for read-across. In an acute oral toxicity study conducted on rats and according to OECD 423, the LD50 was reported to be >2000 mg/kg for WO3. In an acute inhalation toxicity study conducted on rats and according to OECD 403, the LC50 was reported to be >5.36 mg/L for WO3. The acute dermal LD50 for sodium tungstate was determined to be > 2000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28ca3574-d7a5-48db-a50c-5a0ced5e077b/documents/IUC5-5c552a0c-9861-4606-9550-6acb59ec1dc0_9c7272f4-84ac-4c9d-896d-7d6874745636.html,,,,,, Dihydrogen wolframate,7783-03-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28ca3574-d7a5-48db-a50c-5a0ced5e077b/documents/IUC5-5c552a0c-9861-4606-9550-6acb59ec1dc0_9c7272f4-84ac-4c9d-896d-7d6874745636.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dihydrogen wolframate,7783-03-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28ca3574-d7a5-48db-a50c-5a0ced5e077b/documents/IUC5-5c552a0c-9861-4606-9550-6acb59ec1dc0_9c7272f4-84ac-4c9d-896d-7d6874745636.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dihydrogen wolframate,7783-03-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28ca3574-d7a5-48db-a50c-5a0ced5e077b/documents/IUC5-5c552a0c-9861-4606-9550-6acb59ec1dc0_9c7272f4-84ac-4c9d-896d-7d6874745636.html,,inhalation,LC50,5.36 mg/m3,no adverse effect observed, Diindium trioxide,1312-43-2," High quality repeat dose whole body inhalation studies, following OECD guidelines 412 (2 -week exposure) and 413 (13 -week exposure) were conducted on indium oxide (IO) and indium tin oxide (ITO) (Nagano et al 2011) in rats and mice. Specific effects included increased lung weights, alveolar proteinosis, increased inflammatory cell infliltration and hyperplasia of the alveolar epithelium. A further group of animals was used to set-up a 13 -week recovery group at the 0.1 mg/m3 ITO dose level. The comparable results in rats are shown below:  RATS 13 wk study   IO (mg/m3)   IO (mg/m3)   IO (mg/m3)   ITO (mg/m3)   ITO (mg/m3)  ITO (mg/m3)     ITO (mg/m3)+13 wk recovery    ITO (mg/m3)+13 wk recovery   ITO (mg/m3)+13 wk recovery     0  0.1  1  0  0.1  1  0  0.1  NA  Lung weight    ↑  ↑    ↑  ↑    ↑    Alveolar proteinosis     +   + +     +    AM infiltration    + (slight)  +   +   +    +    Inflammatory cell infiltration      +      +    +    Hyperplasia alveolar epithelium      +          +    BALT granuloma                    Alveolar wall fibrosis                +    Pleural thickening                +    LN granuloma      +    +   +  +        NOAEL      LOAEL         AM: alveolar macrophages; LN: Lymph nodes If the results of the studies are evaluated in context with the guidance produced by the SCOEL committee (Ref: European Commission Methodology for the derivation of occupational exposure limits. Scientific Committee on Occupational Exposure Limits (SCOEL). Key documentation (version 7), June 2013) on setting an OEL, where the objective of Council Directive 80/1107/EC is ""The protection of workers against risks to their health and safety from exposure to chemical, physical and biological agents considered harmful"" then the data used to derive an OEL should be separated into the 4 categories listed below: The effects of increasing exposure to chemical substances may be viewed as a continuum: (1) no effects observed (2) compensatory effects or early effects of dubious significance without adverse health consequences (3) early health impairement (clear adverse effects) (4) overt disease, possibly death Effects may be considered to become 'adverse' during the transition from (2) to (3) above Using this guidance when interpreting the results of the 13 -week study in rat with IO it could be concluded that the 0.1 mg/m3 dose level is an NOAEL. The only effect observed at this dose level, infiltration of alveolar macrophage and neutrophils and increased lung weight, could be due to exposure to a relatively insoluble, high density metal salt. Without other clear adverse endpoints present, the 0.1mg/m3 dose level shows an adaptive resonse to the clearance of a relatively insoluble metallic salt and could therefore be defined as a NOAEL for the purpose of defining a DNEL or OEL. For ITO, the adverse effects were more significant even at the lowest dose tested in the rat and all lung/lymph lesions persisted in the 13-week recovery period for ITO (not measured for IO) with progression to alveolar wall fibrosis, alveolar epithelial hyperplasia, infiltration of alveolar macrophages and inflammatory cells at 0.1 mg/m3.   In mice, similar results were observed to those described in the rat studies (lesions more severe with ITO than IO) but with overall lower severity scores compared to rats, particularly for alveolar proteinosis and alveolar macrophage infiltration. There was no recovery period included in the study. In a further study, Nagano et al 2011, conducted a 2 -year carcinogenicity study on ITO in the rat and mouse to OECD Guideline 451 (see below in additional information). The table below present the LOAEL and NOAEL's for the most sensitive respiratory effects observed in the sub-chronic inhalation animal studies conducted with respirable size aerosols of indium oxide and ITO in Fisher 344 rats and B6C3F1 mice. It also calculates an NOAEL for use in subsequent chronic DNEL derivation for IO and ITO. The toxic effects of both compounds in both species were typical of lung inflammation, with the overall response for both compounds being greater in rats and the response for ITO being greater than IO in both species.   MICE IO (mg/m3)         ITO (mg/m3)        13 wk NOAEL 0.1 NA 13 wk LOAEL 1.0 (M/F) 0.1 (M/F) RATS 13 wk NOAEL 0.1 NA 13 wk LOAEL 1 (M/F) 0.1 (M/F) 2 yr NOAEL   NA 2 yr LOAEL   0.01       Choice of NOAEL/LOAEL for DNEL determination 0.1 mg/m3 0.01 mg/m3 Conversion factor from sub-chronic to chronica 2 1 Conversion factor for NOAEL determination from a LOAEL valueb 1 3       Comparable chronic NOAEL for DNEL derivation 0.05 mg/m3 0.0033 mg/m3 a –Conversion for difference in duration of exposure:2 (sub-chronic to chronic exposure) b –To convert a LOAEL to a NOAEL, the REACH TGD (Chapter R.8 of the ‘Guidance on information requirements and chemical safety assessment’) suggests an assessment factor (AF) of 3 as minimum for the majority of cases and going up to a default of 10 for exceptional cases. An AF of 3 is applied to convert LOAEL to NOAEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba393ce5-3eab-43c7-9181-d3f268f9b050/documents/bbe925aa-d484-4ca3-ae01-6bbb473ea260_5dfee677-7cae-4c61-bf20-659a4d5bdecf.html,,,,,, Diindium trioxide,1312-43-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba393ce5-3eab-43c7-9181-d3f268f9b050/documents/bbe925aa-d484-4ca3-ae01-6bbb473ea260_5dfee677-7cae-4c61-bf20-659a4d5bdecf.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.1 mg/m3,adverse effect observed,rat Diindium trioxide,1312-43-2," Assessment of the acute inhalation toxicity of indium oxide in Grosz et al 2012: In2O3 was administered to rats by a single four-hour nose-only inhalation exposure to the dust atmosphere, followed by an observation period of 14 days. No deaths occurred in a group of 10 rats exposed to a mean achieved atmosphere of 5.0 mg/L for 4 hours. The acute inhalation median lethal concentration (LC50) of diindium trioxide, in Wistar Crl:WI rats was therefore considered to be greater than 5.0 mg/L. Assessment of the acute oral toxicity of indium in Asakura et al 2008: A limit study with Crj:CD (SD) IGS rats (SPF) was carried out according to OECD guideline no 401 to assess the oral LD50. No deaths and no abnormalities in clinical signs, body weights, and necropsy findings were observed for any of the animals. An LD50 value >2000mg/kg bw was reported. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba393ce5-3eab-43c7-9181-d3f268f9b050/documents/f4f85692-7019-4637-b4b4-c67dd1a3aca8_5dfee677-7cae-4c61-bf20-659a4d5bdecf.html,,,,,, Diindium trioxide,1312-43-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba393ce5-3eab-43c7-9181-d3f268f9b050/documents/f4f85692-7019-4637-b4b4-c67dd1a3aca8_5dfee677-7cae-4c61-bf20-659a4d5bdecf.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Diindium trioxide,1312-43-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba393ce5-3eab-43c7-9181-d3f268f9b050/documents/f4f85692-7019-4637-b4b4-c67dd1a3aca8_5dfee677-7cae-4c61-bf20-659a4d5bdecf.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Diiodohydroxyquinoline,83-73-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Data is from a long term study (2 years) wherein the TDLo was found to be greater than 120000 mg/kg body weight in humans ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/200cf26a-3824-4d79-9f31-41646a3fd465/documents/IUC5-95e08398-fc64-4fb2-a3f7-d25f5ce9eb64_03fe9c98-b716-46ea-8fb1-470c194d7c69.html,,,,,, Diiodohydroxyquinoline,83-73-8,"From the above study results, it is concluded that the chemical diiodohydroxyquinoline shall not exhibit acute toxicity by the oral, inhalation and dermal route in the concentrations mentioned in the study end points. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/200cf26a-3824-4d79-9f31-41646a3fd465/documents/IUC5-de64d1b0-93ba-4c8e-8cfb-51fe82af9ee5_03fe9c98-b716-46ea-8fb1-470c194d7c69.html,,,,,, Diiodohydroxyquinoline,83-73-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/200cf26a-3824-4d79-9f31-41646a3fd465/documents/IUC5-de64d1b0-93ba-4c8e-8cfb-51fe82af9ee5_03fe9c98-b716-46ea-8fb1-470c194d7c69.html,,oral,LD50,"4,470.499 mg/kg bw",no adverse effect observed, Diiodohydroxyquinoline,83-73-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/200cf26a-3824-4d79-9f31-41646a3fd465/documents/IUC5-de64d1b0-93ba-4c8e-8cfb-51fe82af9ee5_03fe9c98-b716-46ea-8fb1-470c194d7c69.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Diiron magnesium tetraoxide,12068-86-9,"Acute oral toxicity: LD50 > 5000 mg/kg bw (nominal) (OECD 423; GLP compliant) Acute inhalation toxicity: LC50 > 5.06 mg/L air (analytical) (OECD 436; GLP compliant) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study fulfils the rquirements for acute oral toxicity under REACH (Regulation (EC) 1907/2006). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d91de24-0b2c-442a-a425-e866db60d2f0/documents/IUC5-0ac297ef-83b8-48b7-bffe-b38e5b0adee5_4c578a74-bf60-4cf4-ba91-5dfcf2574b1e.html,,,,,, Diiron titanium pentaoxide,12023-27-7," Diiron titanium pentaoxide as a single component has not been tested for systemic toxicity after repeated dosing. However, diiron titanium pentaoxide is a constituent of several pigments and it is therefore considered toxicologically more relevant to administer it as a constituent of a typical pigment mixture with a relatively high content. Therefore, a WoE approach was used to investigate the repeated-dose toxicity of diiron titanium pentaoxide using data from pigments which contain diiron titanium pentaoxide and data from the oxides titanium dioxide (TiO2) and iron oxide (Fe2O3) since Diiron titanium pentaoxide is a mixed oxide of titanium dioxide and iron oxide. Oral: No adverse effects have been observed in a limit dose 90-day oral feeding study in rats with a mica-based pearlescent pigment containing diiron titanium pentaoxide (13.5%). Based on the amount of diiron titanium pentaoxide in the pigment, a NOAEL of > 550 mg/kg bw/day can be calculated for the substance (reference 7.5.1 -1). Furthermore, administration of Titanium Dioxide coated mica containing diiron titanium pentaoxide (2 -7%) in the diet for up to 2 years to rats at concentrations of 10000, 20000 and 50000 ppm, did not significantly alter survival nor demonstrate toxic effects. No indication of oncogenic potential was elicited by the test material at the designated concentration levels (reference 7 .5.1 -3). Based on the concentration of diiron titanium pentaoxide in this pigment (up to 7%) and the food consumption during this chronic toxicity study a NOAEL of 180 mg/kg bw/day and 230 mg/kg bw/day for male and female rats was calculated for the 2-year study. Furthermore, a study according OECD TG 407 was performed with TiO2 using male Sprague-Dawley rats. Under the conditions of this study, the NOEL was 24000 mg/kg bw/day for male rats, based on the lack of any adverse effects at this dose (reference 7.5.1 -2). Inhalation: Titanium dioxide showed adverse pulmonary effects in rats, mice and hamsters after repeated inhalation studies only at concentrations above the maximum tolerated dose (MTD). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4f63706-430d-407d-9e3f-123018e554f6/documents/IUC5-a96a349c-d560-4134-98bb-1ceecd2c0ea6_1500cdc6-cd04-4f9d-88b2-8787da690fc1.html,,,,,, Diiron titanium pentaoxide,12023-27-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4f63706-430d-407d-9e3f-123018e554f6/documents/IUC5-a96a349c-d560-4134-98bb-1ceecd2c0ea6_1500cdc6-cd04-4f9d-88b2-8787da690fc1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,550 mg/kg bw/day,,rat Diiron titanium pentaoxide,12023-27-7," No adverse effects are observed in an oral toxicity study according to OECD TG 401 with the test substance in rats at the limit dose of 5000 mg/kg bw (reference 7.2.1 -1). Effects have been observed in an acute inhalation toxicity study according to OECD TG 403 using the pigment, which contains 11% of the target substance. However, the effects observed are only due to the massive overload effects (at 14600 mg/m3). No effects are expected at the limit dose recommended by the current OECD guideline (i.e. 2000 mg/m3). The test material is considered not toxic after acute inhalation (reference 7.2.2-1). No study is available for the acute dermal toxicity. However, due to 1) the composition of this mixed metal oxide (oxides of iron and titanium), 2) the very low solubility in water, and 3) the assumed negligible bioavailability after dermal application, the performance of an acute dermal toxicity study in rats is considered not necessary. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4f63706-430d-407d-9e3f-123018e554f6/documents/IUC5-04cd4c11-cd86-4387-97c5-c1eb4f5eea87_1500cdc6-cd04-4f9d-88b2-8787da690fc1.html,,,,,, Diiron titanium pentaoxide,12023-27-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4f63706-430d-407d-9e3f-123018e554f6/documents/IUC5-04cd4c11-cd86-4387-97c5-c1eb4f5eea87_1500cdc6-cd04-4f9d-88b2-8787da690fc1.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Diiron titanium pentaoxide,12023-27-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4f63706-430d-407d-9e3f-123018e554f6/documents/IUC5-04cd4c11-cd86-4387-97c5-c1eb4f5eea87_1500cdc6-cd04-4f9d-88b2-8787da690fc1.html,,inhalation,LC50,"4,600 mg/m3",adverse effect observed, Diiron trimolybdenum dodecaoxide,13769-81-8,"NOAEL for systemic toxicity, oral, from a sub-chronic study with sodium molybdate dihydrate in rats (Hoffman, 2011): 17 mg Mo/kg bw/day. Unbounded NOAEC for systemic toxicity, inhalation, from a sub-chronic study with molybdenum trioxide in rats and mice (NTP, 1997): 66.7 mg Mo/m³. Important: both values expressed based on element Mo (for read-across purposes), not on the respective test substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2960420-eae3-4db8-a419-3a80abda6ed7/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_2a836b44-54a6-4841-8305-912770a9cc43.html,,,,,, Diiron trimolybdenum dodecaoxide,13769-81-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2960420-eae3-4db8-a419-3a80abda6ed7/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_2a836b44-54a6-4841-8305-912770a9cc43.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat Diiron trimolybdenum dodecaoxide,13769-81-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2960420-eae3-4db8-a419-3a80abda6ed7/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_2a836b44-54a6-4841-8305-912770a9cc43.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,66.7 mg/m3,,other:rats and mice Diiron trimolybdenum dodecaoxide,13769-81-8," To avoid unnecessary (animal) testing, a comprehensive grouping and read-across concept has been developed amongst several molybdenum containing substances. Acute oral, inhalation and dermal toxicity studies are available for several but not all substances in the category. The following LD50s are therefore either based on test data for the substance in this dossier, or based on read-across within the category: For iron molybdate: LD50 oral: > 2000 mg/kg  (estimated, based on category read-across) LD50 inhalation, 4h: > 5 g/m³ (estimated, based on category read-across) LD50 dermal: > 2000 mg/kg (estimated, based on category read-across) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2960420-eae3-4db8-a419-3a80abda6ed7/documents/IUC5-ae6fe4b3-814d-4f97-a5c0-7031c59cea6f_2a836b44-54a6-4841-8305-912770a9cc43.html,,,,,, Diisobutyl hexahydrophthalate,70969-58-3,Sub-acute toxicity: NOAEL - Males and females: 1000 mg/kg/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fd9fe0e-cb97-410d-90e5-146e121a4ec6/documents/IUC5-988605a1-64e8-4c1e-8ec8-ccbf16103f1b_8f5f3cb3-65ef-4538-bd6d-1f561cf2ff15.html,,,,,, Diisobutyl hexahydrophthalate,70969-58-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fd9fe0e-cb97-410d-90e5-146e121a4ec6/documents/IUC5-988605a1-64e8-4c1e-8ec8-ccbf16103f1b_8f5f3cb3-65ef-4538-bd6d-1f561cf2ff15.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Diisobutyl hexahydrophthalate,70969-58-3,- Acute toxicity:Oral: LD50: >2000 mg/kg in the ratDermal: LD50: > 2000 mg/kg in the rat ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fd9fe0e-cb97-410d-90e5-146e121a4ec6/documents/IUC5-f5ee5544-7a18-48b2-8f56-e888e05e4c0f_8f5f3cb3-65ef-4538-bd6d-1f561cf2ff15.html,,,,,, Diisobutyl hexahydrophthalate,70969-58-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fd9fe0e-cb97-410d-90e5-146e121a4ec6/documents/IUC5-f5ee5544-7a18-48b2-8f56-e888e05e4c0f_8f5f3cb3-65ef-4538-bd6d-1f561cf2ff15.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Diisobutyl hexahydrophthalate,70969-58-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fd9fe0e-cb97-410d-90e5-146e121a4ec6/documents/IUC5-f5ee5544-7a18-48b2-8f56-e888e05e4c0f_8f5f3cb3-65ef-4538-bd6d-1f561cf2ff15.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Diisobutyl hydrogen phosphate,6303-30-6," The pH determination of a 1 g diisobutyl phosphate /100 mL water solution was done with a pH meter equipped with a calibrated single rod glass electrode. A pH-value of 1.5 at 20°C was determined (see IUCLID section 4.20 pH). In addition, the acidity of diisobutyl phosphate was determined in accordance to OECD Guideline 122. The acidity of diisobutyl phosphate calculated as H2SO4 is 23.3 %, equal to a pH of 1.3. This confirms the measurements by glass rod electrode (see IUCLID section 4.20 pH). According to Guidance to Regulation (EC) No 1272/2008 on classification, labelling and packaging (CLP) of substances and mixtures, Version 5.0, July 2017, section 3.2.2.1.2.2. ‘pH and acid/alkaline reserve it is stated’: ‘’In the absence of any other information, a substance is considered as corrosive to skin (Skin Corrosion Category 1) if it has a pH ≤ 2 or a pH ≥ 11,5”. The experimental determined pH-value of diisobutyl phosphate is below pH 2. Therefore, a classification of diisobutyl phosphate as corrosive to skin (Skin Corrosion Category 1) is justified. According to COMMISSION REGULATION (EU) 2016/863 of 31 May 2016 amending Annexes VII and VIII to Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Annex VII, section 8.5. Acute toxicity column 2: The study/ies do(es) not generally need to be conducted if: — the substance is classified as skin corrosion. This criterion is fulfilled as the pH of diisobutyl phosphate is below pH 2. An acute oral toxicity study is therefore not required according to CLP criteria and COMMISSION REGULATION (EU) 2016/863 of 31 May 2016 amending Annexes VII and VIII to Regulation (EC) No 1907/2006. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3a1d0d9-4058-4cf5-9f3d-fe347baf310f/documents/dfd1ada4-4b01-47df-b301-d473983300d0_d4445b42-4faa-46b1-b172-4a9308e0b7b8.html,,,,,, Diisobutylaluminium hydride,1191-15-7," Corrosive. Short chain aluminum alkyls ignite spontaneously on contact with air and therefore are classified pyrophoric. Reactions of aluminum alkyls with liquids are in some cases explosion like. Exposure of mammalian species to aluminum alkyls would not generate meaningful data, and no acute oral toxicity studies are required for this substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe6b8856-3c98-4614-8ec0-54657f8c4384/documents/2f77b9a7-fb34-48e4-8831-cd91e946f175_a0c73509-6472-4d6c-a7bc-fa8706f6e040.html,,,,,, Diisobutylamine,110-96-3," Alkaline corrosives cause liquefaction necrosis. They saponify the fats in the cell membrane, destroying the cell and allowing deep penetration into mucosal tissue. In gastrointestinal tissue an initial inflammatory phase may be followed by tissue necrosis (sometimes resulting in perforation), then granulation and finally stricture formation. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f316c7d9-3de2-43b8-843f-8f8f2b8794bb/documents/d6886439-6896-4e37-8915-dc8a189ce2dc_93076d76-6c58-499a-aec9-9dd620ee60e5.html,,,,,, Diisobutylamine,110-96-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f316c7d9-3de2-43b8-843f-8f8f2b8794bb/documents/d6886439-6896-4e37-8915-dc8a189ce2dc_93076d76-6c58-499a-aec9-9dd620ee60e5.html,,oral,LD50,258 mg/kg bw,adverse effect observed, Diisobutylamine,110-96-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f316c7d9-3de2-43b8-843f-8f8f2b8794bb/documents/d6886439-6896-4e37-8915-dc8a189ce2dc_93076d76-6c58-499a-aec9-9dd620ee60e5.html,,dermal,LD50,"1,001 mg/kg bw",adverse effect observed, Diisodecyl azelate,28472-97-1,"WoE:The subacute systemic oral NOAEL for diisodecyl azelate was found to be 1100 mg/kg bw/day. Read Across substance: CAS No. 27178-16-1, CAS No. 103-23-1 and CAS No. 103-23-1: CAS No. 27178-16-1 - subacute (28 day) NOAEL of 1000 mg/kg bw/day CAS No. 103-23-1 - subacute (28 day) NOAEL of 200 mg/kg bw/day CAS No. 103-24-2 - subacute (28 day) NOAEL of 300 mg/kg bw/day CAS No. 103-23-1 - subchronic (90 day) NOAEL of 630 mg/kg bw/day and >2187 mg/kg bw/day was found for male and female ratsCAS No. 103-23-1 - subchronic (90 day) NOAEL of 200 mg/kg bw/day and 387 mg/kg bw/day was found for male and female mice ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45a461d2-b4ec-4a5c-a355-8924aa8146cd/documents/IUC5-e387e5e9-8e46-48f7-b422-55389ccb29bf_8e08e56a-a822-4569-bf60-daf3efbaa787.html,,,,,, Diisodecyl azelate,28472-97-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45a461d2-b4ec-4a5c-a355-8924aa8146cd/documents/IUC5-e387e5e9-8e46-48f7-b422-55389ccb29bf_8e08e56a-a822-4569-bf60-daf3efbaa787.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Diisodecyl azelate,28472-97-1,Acute rral (OECD 401): LD50 > 2000 mg/kg bw Acute dermal: LD50 > 2000 mg/kg bw Acute inhalation: RA-A from CAS 103-23-1: LC50 > 5.7 mg/L; RA-A from CAS 16958-92-2: LC50 > 3.2 mg/LStudies on acute inhalation toxicity were available for the following Read Across substances (CAS No.): 103-23-1 and 16958-92-2 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45a461d2-b4ec-4a5c-a355-8924aa8146cd/documents/IUC5-baa819c8-de21-46c2-afba-e79e57083c57_8e08e56a-a822-4569-bf60-daf3efbaa787.html,,,,,, Diisodecyl sebacate,28473-19-0,"A guideline OECD 408 90-day repeated-dose toxicity study was performed using DIDS. No effects were observed in female rats at the highest dose (1000 mg/kg bw/day). In the males, due to the observed histopathological changes in the kidney, which most probably corresponds to Alpha 2u globulin deposition (an adverse nephropathy for male rats only) and is not indicative of a risk for human health.Whilst the rat-specific NOAEL for CEREPLAS DIDS in the males is considered to be 300 mg/kg bw/day, the NOAELfor all the human-relevant endpoints is considered to be 1000 mg/kg bw/day, basedon the results of this study.No adverse effects were seen in a 14-day oral study in rats administered DIDA, presumably by gavage, at 1000 mg/kg bw/day (Conning, 1970). In a chronic dietary study, no adverse effects were seen when rats were given DOS at about 10 mg/kg bw/day for up to 19 months (Le Breton, 1952-7).The secondary literature describes a subchronic inhalation study on DEHS, in which groups of 12 rats were exposed to up to 250 mg/m3 for 13 wk. Although the final analysis of the data was not formalised, no significant effects appeared evident [no further details given] (Swift, 1983). No repeated dose dermal studies were available on DIDS (or DIDA or DEHS/DOS). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09d97fbc-f67b-4f6d-9e67-7cce41f1fa74/documents/IUC5-02fc959d-15f7-4f85-b069-c7d4b81d33e8_4fcaf6cf-14d3-4326-a746-09d27372041a.html,,,,,, Diisodecyl sebacate,28473-19-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09d97fbc-f67b-4f6d-9e67-7cce41f1fa74/documents/IUC5-02fc959d-15f7-4f85-b069-c7d4b81d33e8_4fcaf6cf-14d3-4326-a746-09d27372041a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Diisodecyl sebacate,28473-19-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09d97fbc-f67b-4f6d-9e67-7cce41f1fa74/documents/IUC5-02fc959d-15f7-4f85-b069-c7d4b81d33e8_4fcaf6cf-14d3-4326-a746-09d27372041a.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,250 mg/m3,,rat Diisodecyl sebacate,28473-19-0,"No standard acute toxicity studies were available on DIDS.The acute oral toxicity of DIDA was at least 10,000 mg/kg bw in rats and mice in early, pre-GLP studies (Conning, 1970). Similarly high oral LD50 values (> 2000 mg/kg bw) were seen in limited studies involving rodents and ferrets (Conning, 1970; Fiume et al. 2012; Takahashi, 1976).No acute inhalation data were available on DIDS. Only limited acute inhalation data are available on DOS and DEHS, which provide no convincing evidence that DIDS should be classified. The low volatility of these substances indicates that exposure via the inhalation route is not expected. A guideline study, to GLP, reported an acute dermal LD50 of more than 2000 mg/kg bw in rats treated dermally with DIDA (van Otterdijk, 2010b). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09d97fbc-f67b-4f6d-9e67-7cce41f1fa74/documents/IUC5-b4647cd2-6068-48f1-a689-0b5405b230e7_4fcaf6cf-14d3-4326-a746-09d27372041a.html,,,,,, Diisodecyl sebacate,28473-19-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09d97fbc-f67b-4f6d-9e67-7cce41f1fa74/documents/IUC5-b4647cd2-6068-48f1-a689-0b5405b230e7_4fcaf6cf-14d3-4326-a746-09d27372041a.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Diisodecyl sebacate,28473-19-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09d97fbc-f67b-4f6d-9e67-7cce41f1fa74/documents/IUC5-b4647cd2-6068-48f1-a689-0b5405b230e7_4fcaf6cf-14d3-4326-a746-09d27372041a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Diisooctyl 2,2'-[(dioctylstannylene)bis(thio)]diacetate",26401-97-8," Rat 13 week oral study (1970) Under the conditions of the study the 13 week oral no adverse effect level was found to be 150 ppm in male and female rats, the highest dose tested. Dog 14 week oral study (1970) Under the conditions of the study the sub-chronic repeated dose oral no observed adverse effect level was 150 ppm in male and female beagle dogs, the highest dose level tested. Oral 30 days rat and dog (1963) Under the conditions of this study the NOAEL of the test material to male rats and dogs was 25 and 75 ppm, respectively. Read-across data - Rat 13 week oral study (mixture DOTE:MOTE:TOTE, 97: 0.3: 2.7) (CAS No 15571 -58 -1, CAS 27107-89-7, CAS 61912-55-8) The NOAEL was determined to be 10 ppm (equivalent to 0.5 mg/kg bw/day) and the LOAEL was determined to be 25 ppm (equivalent to 1.3 mg/kg bw/day) based on reduced thymus weight. Read-across data - Rat 13 week oral study (mixture DOTE: MOTE. 70:30) (CAS No 15571-58-1 and CAS 27107-89-7) The no effect level for the test material was determined to be 25 ppm (calculated as 1.25 mg/kg/day, based on a food factor of 0.05) based on reduced absolute and relative thymus gland weights. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8776058-6e0a-4ed6-9fe0-6f52aead97a4/documents/9002bd35-edc1-41be-96c0-76e0b0262034_27a3df86-0632-4009-bcda-9c4455bc3326.html,,,,,, "Diisooctyl 2,2'-[(dioctylstannylene)bis(thio)]diacetate",26401-97-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8776058-6e0a-4ed6-9fe0-6f52aead97a4/documents/9002bd35-edc1-41be-96c0-76e0b0262034_27a3df86-0632-4009-bcda-9c4455bc3326.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.5 mg/kg bw/day,,rat "Diisooctyl 2,2'-[(dioctylstannylene)bis(thio)]diacetate",26401-97-8," ORAL TOXICITY Auletta (1984) Under the conditions of this study the acute oral LD50 of the test material is 1800 mg/kg with 95 % confidence interval of 1040 to 2560 mg/kg. INHALATION TOXICITY Under the conditions of the study following a 7 hour treatment to a mixture of 80% registered substance (DOTI) and 20% MOTI (CAS 26401-86-5), no mortality occurred. In some animals, a temporary conjunctivitis was observed during the post-treatment period. DERMAL TOXICITY Read-across to structurally similar substance (DOTE) (CAS No 15571 -58 -1) Under the conditions of this study, the acute dermal toxicity LD50 (rat) of the test material was >2000 mg/kg bw(both sexes). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8776058-6e0a-4ed6-9fe0-6f52aead97a4/documents/2875f6c2-3755-4626-ace3-a70f10b7e89d_27a3df86-0632-4009-bcda-9c4455bc3326.html,,,,,, "Diisooctyl 2,2'-[(dioctylstannylene)bis(thio)]diacetate",26401-97-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8776058-6e0a-4ed6-9fe0-6f52aead97a4/documents/2875f6c2-3755-4626-ace3-a70f10b7e89d_27a3df86-0632-4009-bcda-9c4455bc3326.html,,oral,LD50,"1,800 mg/kg bw",adverse effect observed, "Diisooctyl 2,2'-[(dioctylstannylene)bis(thio)]diacetate",26401-97-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8776058-6e0a-4ed6-9fe0-6f52aead97a4/documents/2875f6c2-3755-4626-ace3-a70f10b7e89d_27a3df86-0632-4009-bcda-9c4455bc3326.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Diisopentyl ether,544-01-4,"In a combined repeated dose study with the reproduction/developmental toxicity screening test in rats with application via the oral route according to OECD Guideline 422 and GLP, a NOAEL of 100 mg/kg bw/day was established based on the increased liver weights (mid and high dose females and high dose males) and treatment-related microscopic findings in thyroid (males), thymus (males) and liver (both sexes), ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/40187dfc-0c3e-411b-9205-a7aa22a597e3/documents/IUC5-230dd661-b76e-4a44-9457-f4d40312184a_90a0e23d-9886-4724-9d1e-26ef7c426a8b.html,,,,,, Diisopentyl ether,544-01-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/40187dfc-0c3e-411b-9205-a7aa22a597e3/documents/IUC5-230dd661-b76e-4a44-9457-f4d40312184a_90a0e23d-9886-4724-9d1e-26ef7c426a8b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Diisopentyl ether,544-01-4,"The substance showed no acute oral toxicity in female rats with an LD50 of > 2000 mg/kg bw. In an acute inhalation study, the LC50 was determined at 2-10 mg/L for male and female rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40187dfc-0c3e-411b-9205-a7aa22a597e3/documents/IUC5-3330c662-b17f-4d8b-b618-6a544bc97ef1_90a0e23d-9886-4724-9d1e-26ef7c426a8b.html,,,,,, Diisopentyl ether,544-01-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40187dfc-0c3e-411b-9205-a7aa22a597e3/documents/IUC5-3330c662-b17f-4d8b-b618-6a544bc97ef1_90a0e23d-9886-4724-9d1e-26ef7c426a8b.html,,inhalation,LC50,"7,000 mg/m3",, "Diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]",71566-54-6, OECD 422 (GLP): NOEL = 1000 mg/kg bw Short-term inhalation study in rats: No systemic toxicity at the highest tested concentration of 60 mg/m3 dust. Local effects observed and fully reversible at the low dose group of 5 mg/m3. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c81b03e-f0e7-493d-a1a4-c25e9d80d038/documents/6738976d-600f-41a8-94d0-2a6727ec57c8_5929d17e-2d2a-4502-b4ea-06da6ae80a52.html,,,,,, "Diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]",71566-54-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c81b03e-f0e7-493d-a1a4-c25e9d80d038/documents/6738976d-600f-41a8-94d0-2a6727ec57c8_5929d17e-2d2a-4502-b4ea-06da6ae80a52.html,Repeated dose toxicity – local effects,inhalation,NOAEC,5 mg/m3,adverse effect observed,rat "Diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]",71566-54-6,"- Oral: LD50 > 5000 mg/kg bw, rat, comparable to OECD TG 401, no GLP, 1983, K2 - Inhalation: LC50 > 2.002 mg/L air, rat, according to OECD TG 403, GLP compliant, 2022, K1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c81b03e-f0e7-493d-a1a4-c25e9d80d038/documents/2775839e-ba83-44e2-81fb-5f611f4d50de_5929d17e-2d2a-4502-b4ea-06da6ae80a52.html,,,,,, "Diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]",71566-54-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c81b03e-f0e7-493d-a1a4-c25e9d80d038/documents/2775839e-ba83-44e2-81fb-5f611f4d50de_5929d17e-2d2a-4502-b4ea-06da6ae80a52.html,,oral,discriminating dose,"> 5,000 mg/kg bw",no adverse effect observed, "Diisopropyl 3,3'-[(2,5-dichloro-1,4-phenylene)bis[iminocarbonyl(2-hydroxy-3,1-naphthylene)azo]]bis[4-methylbenzoate]",71566-54-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c81b03e-f0e7-493d-a1a4-c25e9d80d038/documents/2775839e-ba83-44e2-81fb-5f611f4d50de_5929d17e-2d2a-4502-b4ea-06da6ae80a52.html,,inhalation,discriminating conc.,> 2.002 mg/L,no adverse effect observed, Diisopropyl maleate,10099-70-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6e59819-3ab9-47a5-8509-206a78aafe69/documents/cb0e4e74-0ffe-4301-9123-4945528103d8_1155811b-30e8-4947-89c2-efc2847c9e8c.html,,oral,LD50,"2,140 ",no adverse effect observed, Diisopropyl succinate,924-88-9,"In an acute oral toxicity study performed according to OECD TG 401, diisopropyl succinate did not show increased mortality. Therefore, the oral LD50 was greater than 2000 mg/kg bw in male and female rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a78a3b1a-31c6-43dc-be59-99287ac4dc8a/documents/IUC5-e157e76b-f293-4f5f-b954-9a317bb3641c_db53ba3a-b226-4283-8cb9-ae9fb641b1d6.html,,,,,, Diisopropyl succinate,924-88-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a78a3b1a-31c6-43dc-be59-99287ac4dc8a/documents/IUC5-e157e76b-f293-4f5f-b954-9a317bb3641c_db53ba3a-b226-4283-8cb9-ae9fb641b1d6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Diisopropylbenzene hydroperoxide,26762-93-6,"Repeated dose toxicity study by oral route (OECD 408, KS, Kr.1): the NOAEL (No Observed Adverse Effect Level) was established at 500 mg/kg/day (highest dose tested) in females and males if we exclude the adverse lesions seen in male kidneys (a2u-globulin protein nephropathy-related findings) which are specific to male rats and with no relevance for human risk assessment.    ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5eef44b1-5086-4f45-812c-5fabb0d0a841/documents/IUC5-e36a5d8f-23f5-449f-b7ac-8177e6bc62bf_c9694c41-8902-4c69-b28c-a3dc62eaacc5.html,,,,,, Diisopropylbenzene hydroperoxide,26762-93-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5eef44b1-5086-4f45-812c-5fabb0d0a841/documents/IUC5-e36a5d8f-23f5-449f-b7ac-8177e6bc62bf_c9694c41-8902-4c69-b28c-a3dc62eaacc5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Diisopropylbenzene hydroperoxide,26762-93-6,"- Acute oral toxicity: LD0/rat: 1624 mg/kg bw (OECD 401, KS, Kr.1). - Acute dermal toxicity: LD0/rat: 1118 mg/kg bw (OECD 402, KS, Kr.1). - Acute inhalation toxicity: considered as harmulf if inhaled according to EU criteria.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5eef44b1-5086-4f45-812c-5fabb0d0a841/documents/IUC5-61828a5f-7950-4b1b-afb0-991db6e9b04f_c9694c41-8902-4c69-b28c-a3dc62eaacc5.html,,,,,, Diisopropylbenzene hydroperoxide,26762-93-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5eef44b1-5086-4f45-812c-5fabb0d0a841/documents/IUC5-61828a5f-7950-4b1b-afb0-991db6e9b04f_c9694c41-8902-4c69-b28c-a3dc62eaacc5.html,,oral,discriminating dose,"1,624 mg/kg bw",no adverse effect observed, Diisopropylbenzene hydroperoxide,26762-93-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5eef44b1-5086-4f45-812c-5fabb0d0a841/documents/IUC5-61828a5f-7950-4b1b-afb0-991db6e9b04f_c9694c41-8902-4c69-b28c-a3dc62eaacc5.html,,dermal,discriminating dose,"1,118 mg/kg bw",no adverse effect observed, "Diisotridecyl 3,3'-[(dibutylstannylene)bis(thio)]dipropionate",84896-44-6,"The following studies have been submitted to address the repeated dose toxicity: oral endpoint:Waalkens-Berendsen DH (2003) Dibutyldichlorostannane (CAS # 683-18-1): Reproduction/developmental toxicity screening test in rats, TNO, Project Organisation, Ecotoxicology, Utrechtseweg 48, P.O. Box 370, 3700 AJ Zeist, The Netherlands, Report No.: V 4906, Organotin Environmental Programme (ORTEP) Association, Stabilizer Task Force. Report Date.: 2003-12-04. studBarnes, J. M. and Stoner, H. B. (1958). Toxic properties of some dialkyl and trialkyl tin salts. Brit. J. Industr. Med., 1958, 15, 15.Gaunt et al (1968). Acute and Short-term Toxicity Studies on Di-n-butyltin Dichloride in Rats. Fd Cosmet. Toxicol. Vol. 6, pp. 599-608.Penninks A. H. & Seinen W. (1982). COMPARATIVE TOXICITY OF ALKYLTIN AND ESTERTIN STABILIZERS. Fd Chem. Toxic. Vol. 20. pp. 909 to 916.The Gaunt et al (1968) study has been allocated a Klimisch core of 2 on the basis that the study predates GLP; however, method was comparable to OECD Guideline 408. The effect of DBT exposure on the thymus was not assessed in this study. No information on the stability or homogeneity of the test material in the DBTC-prepared diets. The study was performed with dibutyltin dichloride.The Penninks and Seinen (1982) study has also been allocated a Klimisch score of 2 on the basis that the study is a short-term feeding study with no information on the stability of the test substance in the diet or homogeneity of the test diets provided. The purity of the test substance (dibutyltin dichloride) is not reported. The Barnes and Stoner (1958) study has been allocated a Klimisch score of 4.Dibutyltin chloride was the test substance employed in all the studies presented under repeated dose toxicity. Under gastric conditions, the substance in question is anticipated to hydrolyse to dibutyltin chloride. A read-across approach from dibutyltin chloride was considered acceptable when dosing repeatedly via the oral route. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb49ab22-629e-4e0c-a9e9-faef9f1df86c/documents/IUC5-58e1d44a-4246-4552-b7e6-5621a97fa4bc_048714ff-cf4d-41f5-92b5-ea6702005cf5.html,,,,,, "Diisotridecyl 3,3'-[(dibutylstannylene)bis(thio)]dipropionate",84896-44-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb49ab22-629e-4e0c-a9e9-faef9f1df86c/documents/IUC5-58e1d44a-4246-4552-b7e6-5621a97fa4bc_048714ff-cf4d-41f5-92b5-ea6702005cf5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.3 mg/kg bw/day,,rat "Diisotridecyl 3,3'-[(dibutylstannylene)bis(thio)]dipropionate",84896-44-6,"Oral:Sanders, A 2010 ACUTE ORAL TOXICITY IN THE RAT - FIXED DOSE METHOD Testing Laboratory: Harlan Laboratories Limited, Shardlow Business Park, Shardlow, Derbyshire, DE72 2GD, UK. Owner company: Chemtura Corporation, 199 Benson Road, Middlebury, CONNECTICUT 06749, UNITED STATES OF AMERICA. Report date: 3103/0068The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight (OECD 420).Dermal:Both available acute dermal toxicity studies have included as a weight of evidence.Arcelin. G (2001) Mark 17M: Acute Dermal Toxicity Study in Rats. Testing Laboratory: RCC Ltd, Toxicology Division, Wölferstrasse 4, CH-4414, Füllinsdorf Switzerland. Owner company: Crompton Vinyl Additives GmbH, Chemiestrasse 22, D-68623 Lampertheim, Germany. Report No.: 785687. Report date: 2001-06-21.Sarasin G (1981) Acute Dermal LD50 in the Rat of TK 10'701. Testing Laboratory: CIBA-GEIGY Limited, Basle, Switzerland. Owner company: Plastics and Additives Division, CIBA-GEIGY MARIENBERG GMBH, 6140 Marienberg Post Bensheim. Report No.: 810905. Report date: 1981-09-17Arcelin G (2001) was assigned a reliability score of 1, however this is reduced to 2 as the study is being used for read-across purposes. The study was performed to the guideline OECD 402 and conducted in line with GLP. The second study Sarasin G (1981) was also performed to a method equivalent to OECD 402 and assigned a reliability score of 2.The lowest LD50 was selected as the key value. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb49ab22-629e-4e0c-a9e9-faef9f1df86c/documents/IUC5-db9c6f47-8b30-444c-a8d6-f57bb2a71a83_048714ff-cf4d-41f5-92b5-ea6702005cf5.html,,,,,, "Diisotridecyl 3,3'-[(dibutylstannylene)bis(thio)]dipropionate",84896-44-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb49ab22-629e-4e0c-a9e9-faef9f1df86c/documents/IUC5-db9c6f47-8b30-444c-a8d6-f57bb2a71a83_048714ff-cf4d-41f5-92b5-ea6702005cf5.html,,dermal,LD50,777 mg/kg bw,, Diisotridecyl adipate,26401-35-4,Studies on repeated dose toxicity could not be identified for diisotridecyl adipate. Results for di-2-ethylhexyl adipate are used for read across. NOAELs have only been determined for oral application. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/02f91298-9985-47c8-ab6f-81d02eaf01a2/documents/344adc7e-0d3b-4098-a90d-2218877c6887_ddfb20af-1d62-4ba9-aad2-e10b1412e155.html,,,,,, Diisotridecyl adipate,26401-35-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/02f91298-9985-47c8-ab6f-81d02eaf01a2/documents/344adc7e-0d3b-4098-a90d-2218877c6887_ddfb20af-1d62-4ba9-aad2-e10b1412e155.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,mouse Diisotridecyl adipate,26401-35-4,"The oral LD50 of diisotridecyl adipate was determined to be > 15000 mg/kg bw (limit test) (Moreno/Mobil, 1978a).The dermal LD50 of diisotridecyl adipate was determined to be > 5000 mg/kg bw (Moreno/Mobil, 1978b).Inhalational toxicity is not expected due to the low vapor pressure of diisotridecyl adipate (data waiving: study technically not feasible/appropriate). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02f91298-9985-47c8-ab6f-81d02eaf01a2/documents/3a34c127-7687-4293-9143-b49d16bf8b03_ddfb20af-1d62-4ba9-aad2-e10b1412e155.html,,,,,, Diisotridecyl adipate,26401-35-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02f91298-9985-47c8-ab6f-81d02eaf01a2/documents/3a34c127-7687-4293-9143-b49d16bf8b03_ddfb20af-1d62-4ba9-aad2-e10b1412e155.html,,oral,discriminating dose,"15,000 mg/kg bw",no adverse effect observed, Diisotridecyl adipate,26401-35-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02f91298-9985-47c8-ab6f-81d02eaf01a2/documents/3a34c127-7687-4293-9143-b49d16bf8b03_ddfb20af-1d62-4ba9-aad2-e10b1412e155.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Diisotridecyl adipate,26401-35-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02f91298-9985-47c8-ab6f-81d02eaf01a2/documents/3a34c127-7687-4293-9143-b49d16bf8b03_ddfb20af-1d62-4ba9-aad2-e10b1412e155.html,,inhalation,discriminating conc.,20 mg/m3,no adverse effect observed, Diisotridecyl phosphonate,70955-74-7,"• Repeat dose oral (OECD 422, read-across): No signs of systemic toxicity or reproductive or developmental effects at any dose level up to, and including, 1000 mg/kg/day.• Repeat dose dermal: No studies are available• Repeat dose inhalation: No studies are available ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6ff35b5-5101-4eba-9741-82c66f0e580c/documents/51dfa1a3-f624-42d2-bb79-a27a94d90430_0051a9cd-8977-4f22-af6f-69fa4139f80b.html,,,,,, Diisotridecyl phosphonate,70955-74-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6ff35b5-5101-4eba-9741-82c66f0e580c/documents/51dfa1a3-f624-42d2-bb79-a27a94d90430_0051a9cd-8977-4f22-af6f-69fa4139f80b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Diisotridecyl phosphonate,70955-74-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6ff35b5-5101-4eba-9741-82c66f0e580c/documents/51dfa1a3-f624-42d2-bb79-a27a94d90430_0051a9cd-8977-4f22-af6f-69fa4139f80b.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"5,000 mg/kg bw/day",,rat Diisotridecyl phosphonate,70955-74-7,"There were no signs of acute toxicity via the oral, dermal or inhalation routes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6ff35b5-5101-4eba-9741-82c66f0e580c/documents/e2a3f708-b082-456a-ad33-6efd277c21ec_0051a9cd-8977-4f22-af6f-69fa4139f80b.html,,,,,, Diisotridecyl phosphonate,70955-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6ff35b5-5101-4eba-9741-82c66f0e580c/documents/e2a3f708-b082-456a-ad33-6efd277c21ec_0051a9cd-8977-4f22-af6f-69fa4139f80b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Diisotridecyl phosphonate,70955-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6ff35b5-5101-4eba-9741-82c66f0e580c/documents/e2a3f708-b082-456a-ad33-6efd277c21ec_0051a9cd-8977-4f22-af6f-69fa4139f80b.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Diisotridecyl phosphonate,70955-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6ff35b5-5101-4eba-9741-82c66f0e580c/documents/e2a3f708-b082-456a-ad33-6efd277c21ec_0051a9cd-8977-4f22-af6f-69fa4139f80b.html,,inhalation,LC50,"12,600 mg/m3",no adverse effect observed, Diisotridecyl phthalate,27253-26-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86eb9d55-8d85-4fdf-a1e7-01cf64934549/documents/IUC5-b9cdfd74-4268-46aa-a8b7-65cc9ce5af8b_b8cda6a7-4ea7-43e9-97fc-680b3a28ddf3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Diisotridecyl phthalate,27253-26-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86eb9d55-8d85-4fdf-a1e7-01cf64934549/documents/IUC5-b9cdfd74-4268-46aa-a8b7-65cc9ce5af8b_b8cda6a7-4ea7-43e9-97fc-680b3a28ddf3.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rabbit Diisotridecyl phthalate,27253-26-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86eb9d55-8d85-4fdf-a1e7-01cf64934549/documents/IUC5-b9cdfd74-4268-46aa-a8b7-65cc9ce5af8b_b8cda6a7-4ea7-43e9-97fc-680b3a28ddf3.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,500 mg/m3,,rat Diisotridecyl phthalate,27253-26-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86eb9d55-8d85-4fdf-a1e7-01cf64934549/documents/IUC5-08e2895f-9d1c-4d1d-9dc3-36bb7e053b8e_b8cda6a7-4ea7-43e9-97fc-680b3a28ddf3.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Diisotridecyl phthalate,27253-26-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86eb9d55-8d85-4fdf-a1e7-01cf64934549/documents/IUC5-08e2895f-9d1c-4d1d-9dc3-36bb7e053b8e_b8cda6a7-4ea7-43e9-97fc-680b3a28ddf3.html,,dermal,LD50,"3,160 mg/kg bw",no adverse effect observed, Diisotridecyl phthalate,27253-26-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86eb9d55-8d85-4fdf-a1e7-01cf64934549/documents/IUC5-08e2895f-9d1c-4d1d-9dc3-36bb7e053b8e_b8cda6a7-4ea7-43e9-97fc-680b3a28ddf3.html,,inhalation,discriminating conc.,0.13 mg/m3,no adverse effect observed, Dilanthanum tricarbonate,587-26-8,"Oral:NOAEL (rats) = 10648 ppm Lanthanum carbonat (741 mg/kg bw/d for males, 1126 mg/kg bw/d for females) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f7a923b0-f00b-469c-a3c4-a2f5b08341e7/documents/IUC5-f1fedb6e-6a75-4b47-aaa7-745fa47e6481_31b9de34-4864-464c-beba-308826701ef3.html,,,,,, Dilanthanum tricarbonate,587-26-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f7a923b0-f00b-469c-a3c4-a2f5b08341e7/documents/IUC5-f1fedb6e-6a75-4b47-aaa7-745fa47e6481_31b9de34-4864-464c-beba-308826701ef3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,741 mg/kg bw/day,,rat Dilanthanum tricarbonate,587-26-8,Oral: LD50 (rats) > 30404 mg/kg bw Lanthanum carbonateInhalation: LC50 (rats) > 4509 mg/m³ Lanthanum carbonateDermal: LD50 (rabbit) > 1924 mg/kg bw Lanthanum carbonate ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7a923b0-f00b-469c-a3c4-a2f5b08341e7/documents/IUC5-229e7328-4bdd-44e8-b918-caa18920e52e_31b9de34-4864-464c-beba-308826701ef3.html,,,,,, Dilauroyl peroxide,105-74-8," Based on the results of an apparently well conducted GLP 90-day oral gavage study, the NOAEL of dilauroyl peroxide is 1000 mg/kg/day, the highest dose tested.  There were no mortalities and no effects on any parameters evaluated.     ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8d66f91-3bed-4fd0-9ced-b4191fe88425/documents/IUC5-56b1686e-d3eb-4a66-9a85-c0a5aa6470b6_b0fe21f3-bfe3-4c48-adf6-2a3c0e38bb59.html,,,,,, Dilauroyl peroxide,105-74-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8d66f91-3bed-4fd0-9ced-b4191fe88425/documents/IUC5-56b1686e-d3eb-4a66-9a85-c0a5aa6470b6_b0fe21f3-bfe3-4c48-adf6-2a3c0e38bb59.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dilauroyl peroxide,105-74-8," There are two acute oral, and one acute dermal toxicity studies that demonstrate lack of toxicity of dilauroyl peroxide at the limit dose (2000 mg/kg,  5000 mg/kg and 2000 mg/kg, respectively).  In addition an inhalation study with limited documentation, also demonstrates lack of toxicity at concentrations (200 mg/l dust) well above the limit concentration, as well as granulometry data which did not demonstrate significant inhalable particles. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8d66f91-3bed-4fd0-9ced-b4191fe88425/documents/IUC5-2147d0ea-e660-4b09-ac1d-ad46d8bcd5aa_b0fe21f3-bfe3-4c48-adf6-2a3c0e38bb59.html,,,,,, Dilithium adipate,18621-94-8,"A key 28-day toxicity and reproductive toxicity screen, using the OECD 422 study design, was conducted on rats with dilithium adipate via oral administration. This substance is a member of the dilithium salts of dicarboxylic acids (C6-C10) category and the data from this study have been read across to other members of the category (dilithium azelate and dilithium sebacate) using a category approach - see category read across justification. Dilithium adipate was administered at dose levels of 0, 30, 60 and 125 mg/kg bw/day, which were based on effects from a dose range finding study. No adverse effects related to the administration of the substance were observed, therefore, the NOAEL of the study was determined to be at least 125 mg/kg/day.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3bd3380-b425-4bd5-b8c2-9b140d1eb248/documents/99de236f-cd78-4f20-be1e-cc144fd8c787_cc990fab-c933-4696-85b8-b39f48867ffc.html,,,,,, Dilithium adipate,18621-94-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3bd3380-b425-4bd5-b8c2-9b140d1eb248/documents/99de236f-cd78-4f20-be1e-cc144fd8c787_cc990fab-c933-4696-85b8-b39f48867ffc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,>= 125 mg/kg bw/day,,rat Dilithium adipate,18621-94-8,"Based on the available data, the dilithium salts exhibit acute oral toxicity; with LD50 of 300-2000 mg/kg bw, the substances in the category meet the criteria for acute toxicity category 4. No evidence of acute dermal toxicity was evident from the studies on dilithium adipate and dilithium sebacate and it can be concluded that the remaining category member, with a chain length between the two tested substances, is similarly devoid of classifiable acute dermal toxicity. No acute inhalation toxicity testing has been conducted because the dilithium salts of dicarboxylic salts (C6 - C10) have vapour pressures of <1.3 x 10(-8) Pa at 20°C and are exclusively manufactured in situ in base oil and the use of the grease forms will not result in aerosols, particles or droplets of an inhalable size. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3bd3380-b425-4bd5-b8c2-9b140d1eb248/documents/729d47ea-9cfc-4651-83fe-a2cc72f5b444_cc990fab-c933-4696-85b8-b39f48867ffc.html,,,,,, Dilithium adipate,18621-94-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3bd3380-b425-4bd5-b8c2-9b140d1eb248/documents/729d47ea-9cfc-4651-83fe-a2cc72f5b444_cc990fab-c933-4696-85b8-b39f48867ffc.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, Dilithium adipate,18621-94-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3bd3380-b425-4bd5-b8c2-9b140d1eb248/documents/729d47ea-9cfc-4651-83fe-a2cc72f5b444_cc990fab-c933-4696-85b8-b39f48867ffc.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Dilithium azelate,38900-29-7,"A key 28-day toxicity and reproductive toxicity screen, using the OECD 422 study design, was conducted on rats with dilithium adipate via oral administration. This substance is a member of the dilithium salts of dicarboxylic acids (C6-C10) category and the data from this study have been read across to other members of the category (dilithium azelate and dilithium sebacate) using a category approach - see category read across justification. Dilithium adipate was administered at dose levels of 0, 30, 60 and 125 mg/kg bw/day, which were based on effects from a dose range finding study. No adverse effects related to the administration of the substance were observed, therefore, the NOAEL of the study was determined to be at least 125 mg/kg/day.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7003c2f0-058a-4aa4-b43f-cbcd6edf9a25/documents/99de236f-cd78-4f20-be1e-cc144fd8c787_f84aa5e0-31a8-47a3-960a-25ad4cebc9ae.html,,,,,, Dilithium azelate,38900-29-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7003c2f0-058a-4aa4-b43f-cbcd6edf9a25/documents/99de236f-cd78-4f20-be1e-cc144fd8c787_f84aa5e0-31a8-47a3-960a-25ad4cebc9ae.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,>= 125 mg/kg bw/day,,rat Dilithium azelate,38900-29-7,"Based on the available data, the dilithium salts exhibit acute oral toxicity; with LD50 of 300-2000 mg/kg bw, the substances in the category meet the criteria for acute toxicity category 4. No evidence of acute dermal toxicity was evident from the studies on dilithium adipate and dilithium sebacate and it can be concluded that the remaining category member, with a chain length between the two tested substances, is similarly devoid of classifiable acute dermal toxicity. No acute inhalation toxicity testing has been conducted because the dilithium salts of dicarboxylic salts (C6 - C10) have vapour pressures of <1.3 x 10(-8) Pa at 20°C and are exclusively manufactured in situ in base oil and the use of the grease forms will not result in aerosols, particles or droplets of an inhalable size. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7003c2f0-058a-4aa4-b43f-cbcd6edf9a25/documents/729d47ea-9cfc-4651-83fe-a2cc72f5b444_f84aa5e0-31a8-47a3-960a-25ad4cebc9ae.html,,,,,, Dilithium azelate,38900-29-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7003c2f0-058a-4aa4-b43f-cbcd6edf9a25/documents/729d47ea-9cfc-4651-83fe-a2cc72f5b444_f84aa5e0-31a8-47a3-960a-25ad4cebc9ae.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, Dilithium azelate,38900-29-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7003c2f0-058a-4aa4-b43f-cbcd6edf9a25/documents/729d47ea-9cfc-4651-83fe-a2cc72f5b444_f84aa5e0-31a8-47a3-960a-25ad4cebc9ae.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Dilithium disodium (5,5'-diamino-(μ-4,4'-dihydroxy-1:2-κ-2,O4,O4',-3,3'-[3,3'-dihydroxy-1:2-κ-2-O3,O3'-biphenyl-4,4'-ylenebisazo-1:2-(N3,N4-η:N3',N4'-η)]-dinaphthalene-2,7-disulfonato(8)))dicuprate(2-)",126637-70-5,"Based on the outcome of a Klimisch-1-rated 28 days oral repeated dose toxicity study (NOAEL = 200 mg/kg/d, LOAEL = 900 mg/kg/d) , the substance needs not to be classified as to its repeated dose toxicity properties. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/35835491-9594-4ede-a288-c29711ce41e4/documents/IUC5-0c094b6c-ffa5-4a76-a28c-80f45b0bde6a_5863bdb7-59fb-438d-b430-63d34c44105b.html,,,,,, "Dilithium disodium (5,5'-diamino-(μ-4,4'-dihydroxy-1:2-κ-2,O4,O4',-3,3'-[3,3'-dihydroxy-1:2-κ-2-O3,O3'-biphenyl-4,4'-ylenebisazo-1:2-(N3,N4-η:N3',N4'-η)]-dinaphthalene-2,7-disulfonato(8)))dicuprate(2-)",126637-70-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/35835491-9594-4ede-a288-c29711ce41e4/documents/IUC5-0c094b6c-ffa5-4a76-a28c-80f45b0bde6a_5863bdb7-59fb-438d-b430-63d34c44105b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,, "Dilithium disodium (5,5'-diamino-(μ-4,4'-dihydroxy-1:2-κ-2,O4,O4',-3,3'-[3,3'-dihydroxy-1:2-κ-2-O3,O3'-biphenyl-4,4'-ylenebisazo-1:2-(N3,N4-η:N3',N4'-η)]-dinaphthalene-2,7-disulfonato(8)))dicuprate(2-)",126637-70-5,Two Klimisch-1-rated studies on acute oral and dermal toxicities have been conducted. The oral LD50 value of the substance = 1406 mg/kg body weight. The dermal LD50 > 2000 mg/kg bw. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35835491-9594-4ede-a288-c29711ce41e4/documents/IUC5-2a2aad90-99df-4126-a090-07f77651a0c4_5863bdb7-59fb-438d-b430-63d34c44105b.html,,,,,, "Dilithium disodium (5,5'-diamino-(μ-4,4'-dihydroxy-1:2-κ-2,O4,O4',-3,3'-[3,3'-dihydroxy-1:2-κ-2-O3,O3'-biphenyl-4,4'-ylenebisazo-1:2-(N3,N4-η:N3',N4'-η)]-dinaphthalene-2,7-disulfonato(8)))dicuprate(2-)",126637-70-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35835491-9594-4ede-a288-c29711ce41e4/documents/IUC5-2a2aad90-99df-4126-a090-07f77651a0c4_5863bdb7-59fb-438d-b430-63d34c44105b.html,,oral,LD50,"1,406 mg/kg bw",, "Pentanedioic acid, lithium salt (1:2)",29126-51-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): It is a reliable study with a klimisch score of 1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b838597-4692-49b4-abe6-de1c999d2bc4/documents/882a5e3d-d614-4817-a59a-964c09927e72_03718ff2-345c-4330-baea-7c557e2bf4ab.html,,,,,, "Pentanedioic acid, lithium salt (1:2)",29126-51-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b838597-4692-49b4-abe6-de1c999d2bc4/documents/882a5e3d-d614-4817-a59a-964c09927e72_03718ff2-345c-4330-baea-7c557e2bf4ab.html,,oral,LD50,"1,098 mg/kg bw",adverse effect observed, Dilithium oxide,12057-24-8, Acute toxicity: inhalation: LC50 (4h) 0.94 mg/L aerosol ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7812def6-76d3-4d33-bc2f-5e74adcb06d6/documents/32102a25-01a6-409f-bb35-bd817480bf05_26098175-6e42-427f-8922-bb990dc785a8.html,,,,,, Dilithium oxide,12057-24-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7812def6-76d3-4d33-bc2f-5e74adcb06d6/documents/32102a25-01a6-409f-bb35-bd817480bf05_26098175-6e42-427f-8922-bb990dc785a8.html,,inhalation,LC50,0.94 mg/L,adverse effect observed, Dilithium salicylate,38970-76-2, Acute Toxicity - Oral LD50 550 mg/kg bw for rat (OECD TG 425) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fbed1b1d-251e-4669-914c-6e673e14b101/documents/1b9bf913-12b2-4864-846a-dcae959d3b4e_3bc587f3-bdef-492b-a5bd-b3924225a72d.html,,,,,, Dilithium salicylate,38970-76-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fbed1b1d-251e-4669-914c-6e673e14b101/documents/1b9bf913-12b2-4864-846a-dcae959d3b4e_3bc587f3-bdef-492b-a5bd-b3924225a72d.html,,oral,LD50,550 mg/kg bw,adverse effect observed, Dilithium sebacate,19370-86-6,"A key 28-day toxicity and reproductive toxicity screen, using the OECD 422 study design, was conducted on rats with dilithium adipate via oral administration. This substance is a member of the dilithium salts of dicarboxylic acids (C6-C10) category and the data from this study have been read across to other members of the category (dilithium azelate and dilithium sebacate) using a category approach - see category read across justification. Dilithium adipate was administered at dose levels of 0, 30, 60 and 125 mg/kg bw/day, which were based on effects from a dose range finding study. No adverse effects related to the administration of the substance were observed, therefore, the NOAEL of the study was determined to be at least 125 mg/kg/day.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce067250-2278-409a-a092-13e009bfd9d0/documents/99de236f-cd78-4f20-be1e-cc144fd8c787_3bd97ef0-2b62-48f2-964f-cc29aacd9071.html,,,,,, Dilithium sebacate,19370-86-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce067250-2278-409a-a092-13e009bfd9d0/documents/99de236f-cd78-4f20-be1e-cc144fd8c787_3bd97ef0-2b62-48f2-964f-cc29aacd9071.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,>= 125 mg/kg bw/day,,rat Dilithium sebacate,19370-86-6,"Based on the available data, the dilithium salts exhibit acute oral toxicity; with LD50 of 300-2000 mg/kg bw, the substances in the category meet the criteria for acute toxicity category 4. No evidence of acute dermal toxicity was evident from the studies on dilithium adipate and dilithium sebacate and it can be concluded that the remaining category member, with a chain length between the two tested substances, is similarly devoid of classifiable acute dermal toxicity. No acute inhalation toxicity testing has been conducted because the dilithium salts of dicarboxylic salts (C6 - C10) have vapour pressures of <1.3 x 10(-8) Pa at 20°C and are exclusively manufactured in situ in base oil and the use of the grease forms will not result in aerosols, particles or droplets of an inhalable size. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce067250-2278-409a-a092-13e009bfd9d0/documents/729d47ea-9cfc-4651-83fe-a2cc72f5b444_3bd97ef0-2b62-48f2-964f-cc29aacd9071.html,,,,,, Dilithium sebacate,19370-86-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce067250-2278-409a-a092-13e009bfd9d0/documents/729d47ea-9cfc-4651-83fe-a2cc72f5b444_3bd97ef0-2b62-48f2-964f-cc29aacd9071.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, Dilithium sebacate,19370-86-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce067250-2278-409a-a092-13e009bfd9d0/documents/729d47ea-9cfc-4651-83fe-a2cc72f5b444_3bd97ef0-2b62-48f2-964f-cc29aacd9071.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Dilithium tetraborate,12007-60-2," In a combined 28 -day repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD TG 422) of dilithium tetraborate by oral gavage in rats using doses 0,15, 50 and 150 mg/kg/day, no treatment-related general systemic changes were noted. The parental NOAEL (male and female) based on the outcome of this study is equal to or greater than 150 mg/kg (bw). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f559a5e2-3822-4bf0-870b-16b3e837dd78/documents/5d095705-9f9d-4d0e-9550-d1c25a44c91f_ff320d3f-2b6c-4de4-b216-59c0bf301f4a.html,,,,,, Dilithium tetraborate,12007-60-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f559a5e2-3822-4bf0-870b-16b3e837dd78/documents/5d095705-9f9d-4d0e-9550-d1c25a44c91f_ff320d3f-2b6c-4de4-b216-59c0bf301f4a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Dilithium tetraborate,12007-60-2," The oral LD50 value of dilithium tetraborate in Wistar rats was established to be within the range of 300-2000 mg/kg body weight.  According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 500 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f559a5e2-3822-4bf0-870b-16b3e837dd78/documents/7db0b576-e3bf-4fe7-92c4-5247ee47c736_ff320d3f-2b6c-4de4-b216-59c0bf301f4a.html,,,,,, Dilithium tetraborate,12007-60-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f559a5e2-3822-4bf0-870b-16b3e837dd78/documents/7db0b576-e3bf-4fe7-92c4-5247ee47c736_ff320d3f-2b6c-4de4-b216-59c0bf301f4a.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Dilithium titanate,12031-82-2, Acute toxicity to the rat - fixed dose method: LD50>2000 mg/kg bw.   ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7faf9ad-e2ed-4939-a3a3-8aeb59f5b7ad/documents/b8fdaff8-669e-4dfd-94b6-88758434badb_9bee1eaa-763a-4527-a3ac-49c86ad10738.html,,,,,, Dilithium titanate,12031-82-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7faf9ad-e2ed-4939-a3a3-8aeb59f5b7ad/documents/b8fdaff8-669e-4dfd-94b6-88758434badb_9bee1eaa-763a-4527-a3ac-49c86ad10738.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, dilithium trimanganese nickel octaoxide,12031-75-3," Value used for CSA: NOAEL (oral, systemic, animal data): 2.2 mg Ni/kg bw/day read-across from Ni sulphate hexahydrate (Heim et al 2007) LOAEC (inhalation, local, animal data): 0.5 mg Ni/m3(Dunnick et al, 1995) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d063259b-4d2f-4bff-ba4a-5f371c02437b/documents/1c98ebd0-b187-4fe6-9c6b-15a7a522bec4_7a87c456-3fe6-42c8-9fd1-6fcc5129f970.html,,,,,, dilithium trimanganese nickel octaoxide,12031-75-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d063259b-4d2f-4bff-ba4a-5f371c02437b/documents/1c98ebd0-b187-4fe6-9c6b-15a7a522bec4_7a87c456-3fe6-42c8-9fd1-6fcc5129f970.html,Chronic toxicity – systemic effects,oral,NOAEL,2.2 mg/kg bw/day,,rat dilithium trimanganese nickel octaoxide,12031-75-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d063259b-4d2f-4bff-ba4a-5f371c02437b/documents/1c98ebd0-b187-4fe6-9c6b-15a7a522bec4_7a87c456-3fe6-42c8-9fd1-6fcc5129f970.html,Chronic toxicity – systemic effects,inhalation,LOAEC,0.5 mg/m3,,rat dilithium trimanganese nickel octaoxide,12031-75-3," Value used for CSA: NOAEL (oral, systemic, animal data): >11,000 mg/kg for nickel oxide green (>8,500 mg Ni/kg/day) (EPSL, 2008)                                                                                   9,990 mg/kg for nickel oxide black (6,200 mg Ni/kg/day) (EPSL, 2009) NOAEL (oral, systemic, human data): 0.012 mg Ni (Ni ion)/kg bw/day; based on exacerbated existing dermatitis            (Nielsen et al., 1999) NOAEC (inhalation, systemic, animal data): >5.08 mg/L for nickel oxide green; >5.15 mg/L for nickel oxide black                                                                            (>3,900 mg Ni/m3) (EPSL, 2009/2010) NOAEC (inhalation, local, animal data): 3.9 mg Ni/m3(MMAD =2.9 µm) for local effects(DNEL calculation is based on 16-day repeated dose study-Dunnick et al, 1988; no acute, local effects data available)   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d063259b-4d2f-4bff-ba4a-5f371c02437b/documents/54fe0393-dff4-4cc1-9e67-c9c211f22262_7a87c456-3fe6-42c8-9fd1-6fcc5129f970.html,,,,,, Dilutetium oxide silicate,12168-86-4," Acute oral toxicity The oral LD50 for rats was found to be > 2000 mg/kg bw in the key study, which was performed according to the acute toxic class method (OECD guideline 423) and conform GLP requirements (Zelenák, 2017a). This study was considered reliable without restrictions (Klimisch 1). Based on these results, the test substance is considered not classified as acute oral toxicant. Acute inhalation toxicity In a reliable acute inhalation toxicity study performed according to OECD guideline 403, no deaths occurred in two groups of 5 rats exposed for 4 hours to the maximum feasible aerosol atmosphere concentration that could be tested, namely 4.03 mg/L. This key study (Klimisch 1) was performed conform GLP requirements (Tóth, 2018). Based on the 4-h LC50 value > 4.03 mg/L and relevant data for other rare earth compounds, the substance is considered not to be classified as acute toxicant via inhalation. Acute dermal toxicity The acute oral LD50 is greater than 2000 mg/kg bw and no systemic effects or macroscopic abnormalities were observed in the study available for this endpoint. According to Annex VIII, column 2 of the REACH Regulation (revision May 2016), acute dermal toxicity can be waived if the substance under consideration is not classified as acute oral toxicant or as STOT SE, and no systemic effects have been observed in in vivo studies with dermal exposure. The latter criterion (in vivo skin sensitisation study, Tarcai, 2017) is also fulfilled. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25594dd5-9981-4de9-bf6f-c025466fd110/documents/1bcf6dd2-21d5-456f-822c-6f045f8d9233_f69490f8-04b7-478a-8586-f96ef0359b27.html,,,,,, Dilutetium oxide silicate,12168-86-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25594dd5-9981-4de9-bf6f-c025466fd110/documents/1bcf6dd2-21d5-456f-822c-6f045f8d9233_f69490f8-04b7-478a-8586-f96ef0359b27.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dilutetium oxide silicate,12168-86-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25594dd5-9981-4de9-bf6f-c025466fd110/documents/1bcf6dd2-21d5-456f-822c-6f045f8d9233_f69490f8-04b7-478a-8586-f96ef0359b27.html,,inhalation,LC50,"4,030 mg/m3",no adverse effect observed, Dimanganese trioxide,1317-34-6," Relevant data for repeated toxicity was not available for the target substance. Thus, data from an appropriate read-across partner (manganese sulphate) was used to assess the specific target organ toxicity of dimanganese trioxide (target substance). Sub-chronic and chronic oral repeated dose toxicity studies are available, which were conducted within the US NTP programme for manganese sulphate. Moreover, a sub-chronic inhalation toxicity study in rhesus monkeys is available. Based on the results from the read-across partner, no classfication for specific target organ toxicity of the target substance is warranted. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98cc57f6-e912-4092-8730-21d1259c7f9f/documents/e3a57371-98d5-400c-be21-8235ae120edd_dc432025-e71d-4e4e-9408-76483517e348.html,,,,,, Dimanganese trioxide,1317-34-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98cc57f6-e912-4092-8730-21d1259c7f9f/documents/e3a57371-98d5-400c-be21-8235ae120edd_dc432025-e71d-4e4e-9408-76483517e348.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,2.16 mg/m3,,monkey Dimanganese trioxide,1317-34-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98cc57f6-e912-4092-8730-21d1259c7f9f/documents/e3a57371-98d5-400c-be21-8235ae120edd_dc432025-e71d-4e4e-9408-76483517e348.html,Chronic toxicity – systemic effects,oral,NOAEL,93 mg/kg bw/day,,mouse Dimanganese trioxide,1317-34-6," In an acute oral toxicity study conducted according to OECD guideline 423, six fasted female Wistar rats were given a single oral dose of 2000 mg/kg bw of the target substance dimanganese trioxide (99.9% purity). Animals were then observed for 14 days. No mortality and no adverse signs of toxicity were observed during the observation period. Based on the results, the oral LD50 in rats was established to exceed 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98cc57f6-e912-4092-8730-21d1259c7f9f/documents/1aab5b0f-cf3e-4f2f-8ae6-6328bc60f148_dc432025-e71d-4e4e-9408-76483517e348.html,,,,,, Dimethoxydimethylsilane,1112-39-6,"Repeated dose toxicity: oral, subacute (according to OECD TG 422), rat: NOAEL = 250 mg/kg bw/day oral, subchronic (according to OECD TG 408), rat: NOAEL = 100 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f8a0928-ef89-48db-8f3a-6fa25e71eacb/documents/fa1fa263-386c-4771-8084-810daf6d6f05_923914f3-a4e7-4c8c-ae1a-d0ca9ab1fd98.html,,,,,, Dimethoxydimethylsilane,1112-39-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f8a0928-ef89-48db-8f3a-6fa25e71eacb/documents/fa1fa263-386c-4771-8084-810daf6d6f05_923914f3-a4e7-4c8c-ae1a-d0ca9ab1fd98.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Dimethoxydimethylsilane,1112-39-6,"Oral: WoE approach: not acutely toxic based on repeated dose toxicity studies (DRF and OECD TG 422), RA CAS 78-62-6: LD50=10170 mg/kg bw Inhalation: OECD TG 403: LC50 >4700 mg/m³ Dermal: There are no data available for acute toxicity via the dermal route (data waiving according to Column 2 of REACH Annex VIII, Section 8.5.3). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f8a0928-ef89-48db-8f3a-6fa25e71eacb/documents/a7e86f79-2b97-4da9-a791-a288fb2a3e76_923914f3-a4e7-4c8c-ae1a-d0ca9ab1fd98.html,,,,,, Dimethoxydimethylsilane,1112-39-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f8a0928-ef89-48db-8f3a-6fa25e71eacb/documents/a7e86f79-2b97-4da9-a791-a288fb2a3e76_923914f3-a4e7-4c8c-ae1a-d0ca9ab1fd98.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Dimethoxydimethylsilane,1112-39-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f8a0928-ef89-48db-8f3a-6fa25e71eacb/documents/a7e86f79-2b97-4da9-a791-a288fb2a3e76_923914f3-a4e7-4c8c-ae1a-d0ca9ab1fd98.html,,inhalation,LC50,"> 4,700 mg/m3",no adverse effect observed, Dimethoxydiphenylsilane,6843-66-9,"Acute oral toxicity (OECD TG 401, GLP): LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f952a1e8-a86f-4517-a993-ab8557c4e3ec/documents/7feff766-b492-4ce2-b02b-de851a2da624_8fdff2cf-d42b-4d9f-ac28-58da495434f7.html,,,,,, Dimethoxydiphenylsilane,6843-66-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f952a1e8-a86f-4517-a993-ab8557c4e3ec/documents/7feff766-b492-4ce2-b02b-de851a2da624_8fdff2cf-d42b-4d9f-ac28-58da495434f7.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Dimethoxymethyloctadecylsilane,70851-50-2,"Oral (OECD 422), rat: NOAEL = 300 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45b3cb39-7162-47b2-a656-6af31d8637c8/documents/531a10a8-9d6f-4270-8e64-6b7e4f4f0ac8_b03215e5-ca7c-48b2-a8f5-32b9b36f25d5.html,,,,,, Dimethoxymethyloctadecylsilane,70851-50-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45b3cb39-7162-47b2-a656-6af31d8637c8/documents/531a10a8-9d6f-4270-8e64-6b7e4f4f0ac8_b03215e5-ca7c-48b2-a8f5-32b9b36f25d5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Dimethoxymethyloctadecylsilane,70851-50-2,"Oral (OECD 423), rat: LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45b3cb39-7162-47b2-a656-6af31d8637c8/documents/c1fbcf83-54d1-4515-bc23-e00db1f84fa1_b03215e5-ca7c-48b2-a8f5-32b9b36f25d5.html,,,,,, Dimethoxymethyloctadecylsilane,70851-50-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45b3cb39-7162-47b2-a656-6af31d8637c8/documents/c1fbcf83-54d1-4515-bc23-e00db1f84fa1_b03215e5-ca7c-48b2-a8f5-32b9b36f25d5.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Dimethoxymethylsilane,16881-77-9,"Oral (OECD 408), rat: NOAEL (systemic) >= 300 mg/kg bw/day; NOAEL (local) = 125 mg/kg bw/day Dermal (non-guideline supporting study), rabbit: NOAEL (systemic) = 171 mg/kg bw/day; LOAEL (local) = 0.051 mg/cm2 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e6ced21-a852-4a88-8fbb-6ad9bacc5e47/documents/a75a0b7a-1f28-49cf-9e48-59afda23acc1_02338644-67f9-475c-af3c-1871aabe7d12.html,,,,,, Dimethoxymethylsilane,16881-77-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e6ced21-a852-4a88-8fbb-6ad9bacc5e47/documents/a75a0b7a-1f28-49cf-9e48-59afda23acc1_02338644-67f9-475c-af3c-1871aabe7d12.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,171 mg/kg bw/day,,rabbit Dimethoxymethylsilane,16881-77-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e6ced21-a852-4a88-8fbb-6ad9bacc5e47/documents/a75a0b7a-1f28-49cf-9e48-59afda23acc1_02338644-67f9-475c-af3c-1871aabe7d12.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,>= 300 mg/kg bw/day,,rat Dimethoxymethylsilane,16881-77-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e6ced21-a852-4a88-8fbb-6ad9bacc5e47/documents/a75a0b7a-1f28-49cf-9e48-59afda23acc1_02338644-67f9-475c-af3c-1871aabe7d12.html,Repeated dose toxicity – local effects,dermal,LOAEL,0.051 mg/cm2,adverse effect observed,rabbit Dimethoxymethylsilane,16881-77-9,"Oral (OECD TG 423), rat (female): LD50 > 2000 mg/kg bw (RA CAS 2031-62-1)Inhalation (OECD TG 403), rat: LC50 > 4600 mg/m³ air (limit test) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e6ced21-a852-4a88-8fbb-6ad9bacc5e47/documents/5449a34c-e923-4442-9bd7-6ee03107c450_02338644-67f9-475c-af3c-1871aabe7d12.html,,,,,, Dimethoxymethylsilane,16881-77-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e6ced21-a852-4a88-8fbb-6ad9bacc5e47/documents/5449a34c-e923-4442-9bd7-6ee03107c450_02338644-67f9-475c-af3c-1871aabe7d12.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Dimethoxymethylsilane,16881-77-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e6ced21-a852-4a88-8fbb-6ad9bacc5e47/documents/5449a34c-e923-4442-9bd7-6ee03107c450_02338644-67f9-475c-af3c-1871aabe7d12.html,,inhalation,LC50,"> 4,600 mg/m3",no adverse effect observed, Dimethoxymethylvinylsilane,16753-62-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable guideline study ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93647019-46fe-44bd-a006-fd3dcaa8f715/documents/ff677283-1729-4a27-a192-803012ae836d_d3f26602-6041-4622-91e1-ef3a53d7a114.html,,,,,, Dimethoxymethylvinylsilane,16753-62-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93647019-46fe-44bd-a006-fd3dcaa8f715/documents/ff677283-1729-4a27-a192-803012ae836d_d3f26602-6041-4622-91e1-ef3a53d7a114.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,50 mg/kg bw/day,,rat Dimethoxymethylvinylsilane,16753-62-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93647019-46fe-44bd-a006-fd3dcaa8f715/documents/76d501c0-a4c8-4a14-aa9b-32d94ff1e7d8_d3f26602-6041-4622-91e1-ef3a53d7a114.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, Dimethoxymethylvinylsilane,16753-62-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93647019-46fe-44bd-a006-fd3dcaa8f715/documents/76d501c0-a4c8-4a14-aa9b-32d94ff1e7d8_d3f26602-6041-4622-91e1-ef3a53d7a114.html,,inhalation,LC50,">=5,000 mg/m3",no adverse effect observed, Dimethyl (dimethoxyphosphinyl)succinate,2788-26-3, Acute oral toxicity: discriminating dose = 3942 mg/kg bw Acute dermal toxicity: no study available Acute inhalation toxicity: no study available ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2edb554a-1d29-4af8-9503-31b215425933/documents/23581da1-6d01-4817-9363-9402aa1c5d12_c0ae3746-7880-4eec-b098-f9e8f336d535.html,,,,,, Dimethyl (dimethoxyphosphinyl)succinate,2788-26-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2edb554a-1d29-4af8-9503-31b215425933/documents/23581da1-6d01-4817-9363-9402aa1c5d12_c0ae3746-7880-4eec-b098-f9e8f336d535.html,,oral,discriminating dose,"3,942 mg/kg bw",no adverse effect observed, Dimethyl (p-methoxybenzylidene)malonate,7443-25-6, A NOAEL of 300 mg/kg bw/day could be derived from a reliable combined repeated dose and reproduction screening study in rats. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38315a04-3db8-4d33-a706-43a447ee1e62/documents/8980f8b6-8649-4e86-9d3a-eb13e1f42779_997ef4aa-b523-4497-acb7-b91e4fcf84a0.html,,,,,, Dimethyl (p-methoxybenzylidene)malonate,7443-25-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38315a04-3db8-4d33-a706-43a447ee1e62/documents/8980f8b6-8649-4e86-9d3a-eb13e1f42779_997ef4aa-b523-4497-acb7-b91e4fcf84a0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Dimethyl (p-methoxybenzylidene)malonate,7443-25-6, The oral LD50 in rats was > 2000 mg/kg bw in a reliable study (RL1). There is no study on acute inhalation and dermal toxicity available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38315a04-3db8-4d33-a706-43a447ee1e62/documents/bd98eb3c-6681-4eae-82fe-61ccf064a5be_997ef4aa-b523-4497-acb7-b91e4fcf84a0.html,,,,,, "Dimethyl 2,2'-azobis(2-methylpropionate)",2589-57-3,adverse effects (i.e.mortality) observed in Range Finding studies. No Adverse effects observed in subchronic study. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dbfd3810-1ad2-4288-8540-d4f8b7b4e5e8/documents/38906e0b-e156-4a51-909c-2e40e84bb50f_005198c9-3249-4765-a872-6c95789ee973.html,,,,,, "Dimethyl 2,2'-azobis(2-methylpropionate)",2589-57-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dbfd3810-1ad2-4288-8540-d4f8b7b4e5e8/documents/38906e0b-e156-4a51-909c-2e40e84bb50f_005198c9-3249-4765-a872-6c95789ee973.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "Dimethyl 2,2'-azobis(2-methylpropionate)",2589-57-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbfd3810-1ad2-4288-8540-d4f8b7b4e5e8/documents/f05630d0-d2b1-4479-807a-3ae9156d84dd_005198c9-3249-4765-a872-6c95789ee973.html,,oral,LD50,527 mg/kg bw,adverse effect observed, "Dimethyl 2,2'-azobis(2-methylpropionate)",2589-57-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbfd3810-1ad2-4288-8540-d4f8b7b4e5e8/documents/f05630d0-d2b1-4479-807a-3ae9156d84dd_005198c9-3249-4765-a872-6c95789ee973.html,,inhalation,LC50,"2,034 mg/m3",adverse effect observed, "Dimethyl 2,5-dioxocyclohexane-1,4-dicarboxylate",6289-46-9,"The highest oral doses tested (15000 or 2000 mg/kg bw ) in two separte studies caused no lethality, no clinical signs, no effects on body weight gain and no abnormal macroscoping findings when administered to female rats. Consequently the oral LD50 is above 15000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a882084-615e-4c05-be73-c9f3d24f6f9c/documents/IUC5-10c44d7e-4e95-47f9-ad2a-5e093e668fe1_a4829920-0594-4bcf-9e38-a1af209a036e.html,,,,,, "Dimethyl 2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]terephthalate",35636-63-6,"Oral Gavage A study according to OECD Guideline 422 is a valid investigation of the toxicological effects resulting from repeated oral-gavage administration of the test item to rats. An analogue substance was administered in vehicle (highly purified water) at dosages of 0, 100, 300, and 1000 mg/kg body weight/day, animals in control groups received the vehicle only. Test item was administered to male rats for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum. Under the conditions of this study, no adverse effects were found in males or females up to the highest dose level of 1000 mg/kg bw/day. Inhalation The objective of this study was to determine the toxic potential of the test item when administered for 6 hours/day, 5 days per week, for 04 consecutive weeks by flow-past nose-only inhalation route to Sprague Dawley rats. This study provides information on toxic effects, target organs, the possibility of cumulative effects, the reversibility of effects (after 56 days recovery period), and an estimate of the No Observed Adverse Effects Concentration (NOAEC). A total of 60 (30 males + 30 females) healthy young Sprague Dawley rats were distributed to four groups viz., control (G1), low dose (G2), mid dose (G3), high dose (G4) and two recovery groups [(G1R (Air only) and G4R (high dose)]. Each main and recovery group comprised of 10 animals (5 males and 5 females). Animals allocated to Groups G2, G3 and G4/G4R were exposed to test item Hostaperm Yellow H6G for 6 hours per day, 5 days per week, for 04 consecutive weeks, at a nominal target concentration of 0.001, 0.003 and 0.03 mg/L. Animals of the control group (G1/G1R) received air only inhalation for 6 hours/day for 04 consecutive weeks. The inhalation exposure of test item/air was achieved by a flow-past, nose-only dynamic inhalation exposure system supplied by CH Technologies, USA. All animals were observed once daily for clinical signs and twice daily for mortality. Body weight was recorded before exposure (day 1) and weekly twice first two weeks during exposure period and weekly once for remaining two weeks during exposure period and recovery period. Feed consumption was recorded weekly. Ophthalmoscopic examinations were performed during the acclimatization period for all groups, and during Week4 for main groups (G1and G4), and duringWeek12 for recovery groups (G1Rand G4R). Neurological/Functional tests were performed during Week4 for G1 and G4 groups and during Week12 for recovery group animals. At the end of treatment and recovery periods, all animals were fasted overnight (water was available ad libitum), and the next day, blood, urine, and Broncho alveolar lavage fluid (BALF) samples were collected and analysed. Subsequently, the animals were sacrificed and subjected to gross pathological examination, and the organs were collected, weighed, and preserved. The tissues/organs in vehicle control and high dose group animals including recovery animals were subjected to histopathological examinations. The data recorded for all exposure days relating to the chamber conditions like particle size, temperature, relative humidity, oxygen, and carbon dioxide concentrations determined during the exposure period were found within the specified range. No treatment-related changes in body weight, percent change in body weight with respect to day 1, feed consumption,or ophthalmology were noted. No adverse effects were observed in the neurological/functional examination tests. No adverse effects were observed in haematology, clinical chemistry, coagulation, BALF analysis,or urinalysis parameters. No toxicologically significant changes were observed infasting body weight, absolute organ weight, or relative organ weight. There were no test item-related, microscopic findings in animals evaluated after terminal and recovery period in the study. Few microscopic findings observed in this study such as ultimobranchial cyst in thyroid gland, epithelial cysts in thymus and all other findings were considered incidental as they occurred randomly across the dose groups including concurrent controls and/or were expected in laboratory rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Valid: Guideline study ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab85849a-92bb-4ef9-902a-59fefc63f765/documents/41325f02-c8c6-4a05-b002-7127982ee342_3b5dab63-ecfe-4dc7-8682-57f49ad6d814.html,,,,,, "Dimethyl 2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]terephthalate",35636-63-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab85849a-92bb-4ef9-902a-59fefc63f765/documents/41325f02-c8c6-4a05-b002-7127982ee342_3b5dab63-ecfe-4dc7-8682-57f49ad6d814.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Dimethyl 2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]terephthalate",35636-63-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab85849a-92bb-4ef9-902a-59fefc63f765/documents/41325f02-c8c6-4a05-b002-7127982ee342_3b5dab63-ecfe-4dc7-8682-57f49ad6d814.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat "Dimethyl 2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]terephthalate",35636-63-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab85849a-92bb-4ef9-902a-59fefc63f765/documents/41325f02-c8c6-4a05-b002-7127982ee342_3b5dab63-ecfe-4dc7-8682-57f49ad6d814.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat "Dimethyl 2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]terephthalate",35636-63-6," Single application of 15000 mg/kg bw of an analogue substance did not cause lethality in female Wistar rats during the 14 day observation period, resulting in a LD50 > 15000 mg/kg bw. Exposure of male and female Wistar rats to 1274 mg/m³ of an analogue substance i.e. maximum technically feasible concentration, for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 1274 mg/m³. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab85849a-92bb-4ef9-902a-59fefc63f765/documents/f5c80a3e-39a2-47de-92b4-558489d3b04d_3b5dab63-ecfe-4dc7-8682-57f49ad6d814.html,,,,,, "Dimethyl 2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]terephthalate",35636-63-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab85849a-92bb-4ef9-902a-59fefc63f765/documents/f5c80a3e-39a2-47de-92b4-558489d3b04d_3b5dab63-ecfe-4dc7-8682-57f49ad6d814.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "Dimethyl 2-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]terephthalate",35636-63-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab85849a-92bb-4ef9-902a-59fefc63f765/documents/f5c80a3e-39a2-47de-92b4-558489d3b04d_3b5dab63-ecfe-4dc7-8682-57f49ad6d814.html,,inhalation,LC50,"1,274 mg/m3",no adverse effect observed, "Dimethyl 5-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azoterephthalate",29920-31-8,"This study is a valid investigation of the toxicological effects resulting from repeated oral-gavage administration of the analogue substance Pigment Orange 36 to rats (according to OECD 422, GLP compliant). The test item was administered in vehicle (highly purified water) at dosages of 0, 100, 300, and 1000 mg/kg body weight/day, animals in control groups received the vehicle only. Test item was administered to male rats for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum. All animals survived the scheduled study period. During the treatment, faeces stained red with dose-dependent intensity of discoloration were noted in all males and females receiving test material. This observation was due to staining properties of the test item. No effects on food consumption were noted in males at any dose level. Body weight gain was slightly but statistically significantly reduced in males at the dose level of 1000 mg/kg bw/day during the pre-pairing period. No differences in body weight gain were noted at any dose level during the remaining study period. Body weights of males in all dose groups were similar to the respective control values during the entire study period. Because lower body weight gain at the high-dose levels was reversible and did not cause significant changes in body weights, this effect was considered not to be adverse. Food consumption, body weights and body weight gain of females were not affected by the treatment at any dose level. No further test item-related observations were noted in males or females at any dose level during the live part of the study. Terminal examinations revealed changes in motility of sperms in all dose groups. These effects, however could not be confirmed in a separate study designed to verify these effects. No further effects on male reproductive system were noted during the study. Sperm morphology and sperm count at the high-dose level was similar to the control values. Weights of male reproductive organs, macroscopical and histopathological examination of testes and epididymides gave no indication of any treatment-related effect. Further, no indication of effects on reproduction was noted within this study up to and including the highest dose level. For this reason, changes in motility of sperms were considered not to be adverse in this study. Based on these results, the NOAEL (No Observed Adverse Effect Level) for general toxicity in males and females and in this study was considered to be 1000 mg/kg bw/day, the highest dose level tested.   Based on the observed results in a subacute inhalation study in rats, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item was found to be 0.03 mg/L when exposed for 6 hours/day, 5 days/week, for 4 weeks by flow-past nose-only inhalation route to Sprague Dawley rats. The nominal dose of 0.03 mg/L (6 hrs/day, 5 days/week) is the actual exposure concentration in males and females.   As there were no treatment related effects on systemic, reproduction and fertility parameters up to and including the highest dose tested 1000 mg/kg bwt/day, the No Observed Adverse Effect Level (NOAEL) for Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test by Oral Gavage in Wistar Rats for the test item is determined to be 1000 mg/kg bwt/day under the test conditions and doses employed. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): reöiable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable with restrictions: read across ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c49ce4d1-aece-4635-9d98-b05bec9f39a2/documents/51066e00-4a77-414c-a0b3-f4416f2f63d1_6bfea5c0-d336-428e-bb08-aba49d09ca69.html,,,,,, "Dimethyl 5-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azoterephthalate",29920-31-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c49ce4d1-aece-4635-9d98-b05bec9f39a2/documents/51066e00-4a77-414c-a0b3-f4416f2f63d1_6bfea5c0-d336-428e-bb08-aba49d09ca69.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Dimethyl 5-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azoterephthalate",29920-31-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c49ce4d1-aece-4635-9d98-b05bec9f39a2/documents/51066e00-4a77-414c-a0b3-f4416f2f63d1_6bfea5c0-d336-428e-bb08-aba49d09ca69.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat "Dimethyl 5-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azoterephthalate",29920-31-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c49ce4d1-aece-4635-9d98-b05bec9f39a2/documents/51066e00-4a77-414c-a0b3-f4416f2f63d1_6bfea5c0-d336-428e-bb08-aba49d09ca69.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat "Dimethyl 5-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azoterephthalate",29920-31-8," Single oral application of 15000 mg/kg bw of the test substance did not cause lethality in female Wistar rats during the 7 day observation period, resulting in a LD50 > 15000 mg/kg bw. Inhalation exposure of male and female Wistar rats to 1274 mg/m³ (i.e. maximum technically feasible concentration) of an analogue substance (PO36) for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 1274 mg/m³. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c49ce4d1-aece-4635-9d98-b05bec9f39a2/documents/04c88ed0-aca4-4d0f-974f-64bcd97991cf_6bfea5c0-d336-428e-bb08-aba49d09ca69.html,,,,,, Dimethyl acetylsuccinate,10420-33-4,"Acute oral toxicity, OECD401, EU B.1: LD50 >2000 mg/kg body weightAcute toxicity via inhalation: Waiver, see also below. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01a3c2b8-7372-4b38-84b3-1bfde913d72d/documents/IUC5-a2abeb57-2e0d-48fc-8b9c-6f5fd305688d_95b57a64-7db4-44c9-adb7-1d6cfcaa04fa.html,,,,,, Dimethyl acetylsuccinate,10420-33-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01a3c2b8-7372-4b38-84b3-1bfde913d72d/documents/IUC5-a2abeb57-2e0d-48fc-8b9c-6f5fd305688d_95b57a64-7db4-44c9-adb7-1d6cfcaa04fa.html,,oral,LD50,"2,000 mg/kg bw",, "Dimethyl cyclohexane-1,4-dicarboxylate",94-60-0,"Repeated dose toxicity: There are currently no experimental studies for DMCD available. However, there are data for a structural analogue available: 1,4-cyclohexanedicarboxylic acid (CHDA), a principal metabolite of DMCD. - 4-week (subacute) Repeated Dose oral Toxicity Study (SS), CHDA, oral rat, NOEL = 871 mg/kg bw/day for males and NOEL = 894 mg/kg bw/day for females - 13-week (subchronic) Repeated Dose oral Toxicity Study (KS), CHDA, oral, rat, NOAEL = 300 mg/kg bw/day   The now available Final Decision on a compliance check of DMCD requested an OECD 407, which need to be conducted and presented by 21st July 2025.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92f6ec43-aafd-488a-adb5-8f6ad5677da8/documents/91254d48-a679-4ca9-8bb8-f972ead9e62c_69be54e1-8882-46c4-8dc4-e732f3b811b9.html,,,,,, "Dimethyl cyclohexane-1,4-dicarboxylate",94-60-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92f6ec43-aafd-488a-adb5-8f6ad5677da8/documents/91254d48-a679-4ca9-8bb8-f972ead9e62c_69be54e1-8882-46c4-8dc4-e732f3b811b9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,871 mg/kg bw/day,,rat "Dimethyl cyclohexane-1,4-dicarboxylate",94-60-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92f6ec43-aafd-488a-adb5-8f6ad5677da8/documents/91254d48-a679-4ca9-8bb8-f972ead9e62c_69be54e1-8882-46c4-8dc4-e732f3b811b9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Dimethyl cyclohexane-1,4-dicarboxylate",94-60-0,"Key study (Shepard, 1996): OECD 401, rat, GLP: LD50 > 2000 mg/kg  Key study (Dickey, 1957): comparable to OECD 403, rat: LC50 > 2.91 mg/L (highest concentration tested)   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92f6ec43-aafd-488a-adb5-8f6ad5677da8/documents/bc679127-f262-4293-86d7-6d8ce68384aa_69be54e1-8882-46c4-8dc4-e732f3b811b9.html,,,,,, "Dimethyl cyclohexane-1,4-dicarboxylate",94-60-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92f6ec43-aafd-488a-adb5-8f6ad5677da8/documents/bc679127-f262-4293-86d7-6d8ce68384aa_69be54e1-8882-46c4-8dc4-e732f3b811b9.html,,oral,LD50,"> 2,812 mg/kg bw",adverse effect observed, "Dimethyl cyclohexane-1,4-dicarboxylate",94-60-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92f6ec43-aafd-488a-adb5-8f6ad5677da8/documents/bc679127-f262-4293-86d7-6d8ce68384aa_69be54e1-8882-46c4-8dc4-e732f3b811b9.html,,inhalation,LC50,> 2.91 mg/L,no adverse effect observed, Dimethyl disulphide,624-92-0,"DMDS has been tested in three 90-day repeated dose toxicity studies by inhalation (Collins, 1992, Kim et al, 2006 and Nemec, 2006). The critical effect identified in 2 of these studies was local contact toxicity observed as epithelial changes in the nasal cavity, indicative of local irritation. This was a transient finding, generally reversible after four weeks and was observed from 10 ppm (Collins, 1992). A NOAEC of 5 ppm was identified (Nemec, 2006). In addition to local contact toxicity lower total motor activity counts were observed in week 12 at the concentration of 80 ppm, with a no-observed adverse effect concentration (NOAEC) of 20 ppm (Nemec, 2006). Reduced body weights and food consumption were observed from 25 ppm (Kim et al., 2006) with a NOAEC of 20 ppm (Nemec, 2006). Slight effects on red blood cells and some clinical chemistry parameters were observed at the top concentration of 250 ppm (Collins, 1992) with a NOAEC of 125 ppm (Kim et al., 2006).  Overall, the NOAECs for systemic toxicity and nasal irritation were 20 ppm (77 mg/m3) and 5 ppm (19.25 mg/m3), respectively. DMDS has been tested in one 28-day repeated dose toxicity by dermal route in rabbits (Prinsen 1990). The no-adverse-effect level (NOAEL) of DMDS for systemic toxicity is 0.1 ml/kg/day (106.3 mg/kg bw/day) and the NOAEL for local irritation is less than 0.01 ml/kg/day (8.5 mg/cm²). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): GLP guideline study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): GLP guideline study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): GLP guideline studies Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): GLP guideline study ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3d6a72c-4f54-4927-a6f1-1ff22200beed/documents/IUC5-674c6b87-490e-4250-8a6c-7b117222b747_1e377710-537b-42f4-afa9-0053de541e96.html,,,,,, Dimethyl disulphide,624-92-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3d6a72c-4f54-4927-a6f1-1ff22200beed/documents/IUC5-674c6b87-490e-4250-8a6c-7b117222b747_1e377710-537b-42f4-afa9-0053de541e96.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,106.3 mg/kg bw/day,,rabbit Dimethyl disulphide,624-92-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3d6a72c-4f54-4927-a6f1-1ff22200beed/documents/IUC5-674c6b87-490e-4250-8a6c-7b117222b747_1e377710-537b-42f4-afa9-0053de541e96.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,77 mg/m3,,rat Dimethyl disulphide,624-92-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3d6a72c-4f54-4927-a6f1-1ff22200beed/documents/IUC5-674c6b87-490e-4250-8a6c-7b117222b747_1e377710-537b-42f4-afa9-0053de541e96.html,Repeated dose toxicity – local effects,dermal,LOAEL,8.5 mg/cm2,adverse effect observed,rabbit Dimethyl disulphide,624-92-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3d6a72c-4f54-4927-a6f1-1ff22200beed/documents/IUC5-674c6b87-490e-4250-8a6c-7b117222b747_1e377710-537b-42f4-afa9-0053de541e96.html,Repeated dose toxicity – local effects,inhalation,NOAEC,19 mg/m3,adverse effect observed,rat Dimethyl disulphide,624-92-0,"Acute oral, dermal and inhalation toxicity studies were available on DMDS. The oral LD50 was 190 mg/kg bw in rats (Shapiro 1985),  the dermal LD0 was higher than 2000 mg/kg bw in rats (Yasso, 2015) and the 4h-LD50 in rats was 1310 ppm, equivalent to 5.05 mg/L (Kirkpatrick, 2005). In acute inhalation studies in which rats were exposed to DMDS vapours, functional damage in the upper respiratory tract (degeneration of transitional and olfactory nasal epithelium) was observed. In acute dermal studies, DMDS induces transient depression of CNS function at non-lethal doses. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Shapiro studies are considered to be reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): GLP guideline study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): GLP guideline study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3d6a72c-4f54-4927-a6f1-1ff22200beed/documents/IUC5-bcdc0b0d-e706-4506-adc1-667890886d2d_1e377710-537b-42f4-afa9-0053de541e96.html,,,,,, Dimethyl disulphide,624-92-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3d6a72c-4f54-4927-a6f1-1ff22200beed/documents/IUC5-bcdc0b0d-e706-4506-adc1-667890886d2d_1e377710-537b-42f4-afa9-0053de541e96.html,,oral,LD50,190 mg/kg bw,adverse effect observed, Dimethyl disulphide,624-92-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3d6a72c-4f54-4927-a6f1-1ff22200beed/documents/IUC5-bcdc0b0d-e706-4506-adc1-667890886d2d_1e377710-537b-42f4-afa9-0053de541e96.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, Dimethyl disulphide,624-92-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3d6a72c-4f54-4927-a6f1-1ff22200beed/documents/IUC5-bcdc0b0d-e706-4506-adc1-667890886d2d_1e377710-537b-42f4-afa9-0053de541e96.html,,inhalation,LC50,"5,046 mg/m3",adverse effect observed, Dimethyl heptanedioate,1732-08-7," Acute toxicity - oral route: LD50 > 2000 mg/kg bw (OECD 423, GLP, K, rel.1) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78918ceb-5049-42b4-b42c-f5cfca65f25c/documents/75cb0eef-ca84-4173-9fd9-3b30adf22cdb_e0fd8362-1fb0-4086-a818-8efbeeb8fdc5.html,,,,,, Dimethyl heptanedioate,1732-08-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78918ceb-5049-42b4-b42c-f5cfca65f25c/documents/75cb0eef-ca84-4173-9fd9-3b30adf22cdb_e0fd8362-1fb0-4086-a818-8efbeeb8fdc5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dimethyl itaconate,617-52-7,"Repeated dose toxicity:- oral: LOAEL (local) = 350 mg/kg bw/day; NOAEL (systemic) = ≥350 mg/kg bw/day, NOAEL (ocal) = 100 mg/kg bw/day, OECD TG 408/415 (Fulcher & Watson 2014)- inhalation: waiver- dermal: waiver ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73db4e62-f397-447d-aeb4-5aefc68db184/documents/IUC5-61773c28-ec87-422f-a34c-87f7ac221665_0bcea47d-0058-4a12-b9ee-51de393882ab.html,,,,,, Dimethyl itaconate,617-52-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73db4e62-f397-447d-aeb4-5aefc68db184/documents/IUC5-61773c28-ec87-422f-a34c-87f7ac221665_0bcea47d-0058-4a12-b9ee-51de393882ab.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,350 mg/kg bw/day,,rat Dimethyl itaconate,617-52-7,"Acute toxicity: - oral: LD50 > 2000 mg/kg bw, OECD TG 420; Bradshaw / 2014 / rat- inhalation: waiver- dermal: waiver ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73db4e62-f397-447d-aeb4-5aefc68db184/documents/IUC5-3554901f-d6d2-42ab-9010-16477464b393_0bcea47d-0058-4a12-b9ee-51de393882ab.html,,,,,, Dimethyl methylphosphonate,756-79-6,"Although the toxicity to the kidney etc. was indicated (NTP TR323 (1987) and RTECS (2004)), all effects occured are remarkably high doses. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13395e00-956d-417f-8672-f835d866918a/documents/IUC5-ed14aa7f-c13d-4100-bb57-4569b1744044_25aaf891-f637-4058-a060-6e6a28f83a85.html,,,,,, Dimethyl methylphosphonate,756-79-6,DMMP is of low acute oral toxicity after gavage application. LD50 values were reported to be higher than 5000 mg/kg bw in several reliable studies. It was also found to be of low acute dermal toxicity as tested with doses of 2000 mg/kg bw. No mortality was observed in an acute inhalation study at the dose of > 2589 mg/m³ air . All studies were performed in a design sufficiently similar or identical to the current OECD testing guideline. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13395e00-956d-417f-8672-f835d866918a/documents/IUC5-7f32e76d-7097-4379-abb1-ceb400b1ce24_25aaf891-f637-4058-a060-6e6a28f83a85.html,,,,,, Dimethyl octadecylphosphonate,25371-54-4,A subacute toxicity study was performed to assess the repeated dose toxicity of dimethyloctadecylphosphonate (also known as DMOP). The study was an OECD 422 ‘combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test’ in which males were exposure for 36 days and females were exposed for 47-60 days. From the results presented in this report a parenteral No Observed Adverse Effect Level (NOAEL) of 300 mg/kg/day was established. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff3ddafa-2a7b-4591-88d1-641264bd4bc3/documents/IUC5-c6fd0d76-1c88-478e-a354-3bedfa654846_23beb2c7-1a67-45fa-9e51-bf5ba25b2c3f.html,,,,,, Dimethyl octadecylphosphonate,25371-54-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff3ddafa-2a7b-4591-88d1-641264bd4bc3/documents/IUC5-c6fd0d76-1c88-478e-a354-3bedfa654846_23beb2c7-1a67-45fa-9e51-bf5ba25b2c3f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Dimethyl octadecylphosphonate,25371-54-4,Acute toxicity oral: LD50 > 2000 mg/kg bodyweight (OECD 420)Acute toxicity dermal: LD50 > 2000 mg/kg bodyweight (non-guideline) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff3ddafa-2a7b-4591-88d1-641264bd4bc3/documents/IUC5-74a01b6b-ca6e-4713-8f7d-29cae3e7c3b7_23beb2c7-1a67-45fa-9e51-bf5ba25b2c3f.html,,,,,, Dimethyl octadecylphosphonate,25371-54-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff3ddafa-2a7b-4591-88d1-641264bd4bc3/documents/IUC5-74a01b6b-ca6e-4713-8f7d-29cae3e7c3b7_23beb2c7-1a67-45fa-9e51-bf5ba25b2c3f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dimethyl octadecylphosphonate,25371-54-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff3ddafa-2a7b-4591-88d1-641264bd4bc3/documents/IUC5-74a01b6b-ca6e-4713-8f7d-29cae3e7c3b7_23beb2c7-1a67-45fa-9e51-bf5ba25b2c3f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dimethyl phosphonate,868-85-9," -Repeated dose toxicity: oral: NOAEL (male) =200 mg/kg/bw/day; NOAEL (female)= 100 mg/kg bw/day similar to OECD guideline 408; 6 concentrations (0, 25, 50, 100, 200, 400 mg/kg bw/day) orally administered to male and female rats. -Repeated dose toxicity: oral: NOAEL (male/female) = 95 mg/kg/bw/day, OECD guideline 408; 6 concentrations (0, 95, 190, 375, 750, 1500 mg/kg bw /day) orally administered to mouse. -Repeated dose toxicity: oral: NOAEL= 250 mg/kg bw/day; 15 days no guideline followed; 6 concentrations (0, 250, 500, 1000, 2000, or 3000 mg/kg bw/day) orally administered to rats. -Repeated dose toxicity: oral: LOAEL= 250mg/kg bw/day; 15 days, no guideline followed; 6 concentrations (0, 250, 500, 1000, 2000, or 3000 mg/kg bw/day) orally administered to mice. -Repeated dose toxicity: oral: LOAEL (male) =100 kg/bw/day; 2 years, similar to OECD guideline 451; 3 concentrations (males: 0, 100, 200 mg/kg bw/day; females: 0, 50, 100 mg/kg bw/day female rat) orally administered to rats. -Repeated dose toxicity: oral: LOAEL (male/female) = 100 mg/kg bw/day; 2 years similar to OECD guideline 451; 3 concentrations (0, 100, 200 mg/kg bw /day) orally administered to mice. -Repeated dose toxicity: inhalation and dermal: waiver ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dd85f24-3473-4a7d-810a-98edbbec7523/documents/IUC5-9b9348c9-56c6-4119-b7d2-ef17e288e11a_11a1e044-6f6b-4c04-b9c5-216d46ed45f3.html,,,,,, Dimethyl phosphonate,868-85-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dd85f24-3473-4a7d-810a-98edbbec7523/documents/IUC5-9b9348c9-56c6-4119-b7d2-ef17e288e11a_11a1e044-6f6b-4c04-b9c5-216d46ed45f3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Dimethyl phosphonate,868-85-9," -Acute toxicity oral (rat) LD50 (female) = 3040 mg/kg bw; LD50 (male) = 3283 mg/kg bw, method similar to OECD TG 401; -Acute toxicity oral (mouse) LD50 (male) = 2815 mg/kg bw; method similar to OECD TG 401 -Acute toxicity: dermal : waiver -Acute toxicity: inhalation (rat, mouse, guinea pig) LC50 > 7100 mg/m³, limit test, no guideline followed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dd85f24-3473-4a7d-810a-98edbbec7523/documents/IUC5-067103f5-5b1f-4e6b-8c47-11bd0387b5d1_11a1e044-6f6b-4c04-b9c5-216d46ed45f3.html,,,,,, Dimethyl phosphonate,868-85-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dd85f24-3473-4a7d-810a-98edbbec7523/documents/IUC5-067103f5-5b1f-4e6b-8c47-11bd0387b5d1_11a1e044-6f6b-4c04-b9c5-216d46ed45f3.html,,oral,LD50,"3,040 mg/kg bw",adverse effect observed, Dimethyl phosphonate,868-85-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dd85f24-3473-4a7d-810a-98edbbec7523/documents/IUC5-067103f5-5b1f-4e6b-8c47-11bd0387b5d1_11a1e044-6f6b-4c04-b9c5-216d46ed45f3.html,,inhalation,discriminating conc.,"7,100 mg/m3",adverse effect observed, Dimethyl propylphosphonate,18755-43-6,"Two subacute (28 days) repeated dose toxicity studies are available. In the first study dimethyl propylphosphonate was administered in doses of 0, 40, 200 and 1000 mg/kg bw . In a supplementary subacute study dimethyl propylphosphonate was administered in doses of 0, 5 and 20 mg/kg bw for a period of 4 weeks.Based on alpha-2-microglobulin nephropathy findings a NOEL for dimethyl propylphosphonate cannot be established for male rats. However, as the alpha-2-microglobulin nephropathy of the male rat is generally not regarded to be relevant for man, a NOAEL for effects not related to alpha-2-microglobulin, and consequently relevant for human risk assessment, can be established at 20 mg/kg body weight/day in male rats. For female rats a NOAEL at 20 mg/kg body weight/day is derived. Overall, a NOAEL for effects not related to alpha-2-microglobulin, and consequently relevant for human risk assessment, can be established at 20 mg/kg body weight/day in male and female rats in comprehensive sub-acute toxicity studies. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53e50fbb-f07b-4e58-a1ae-700a794fcc67/documents/IUC5-95132e12-5304-4d6a-b546-2b4a9848691d_69931411-29a4-40a4-aa84-fe522d49cdf5.html,,,,,, Dimethyl propylphosphonate,18755-43-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53e50fbb-f07b-4e58-a1ae-700a794fcc67/documents/IUC5-95132e12-5304-4d6a-b546-2b4a9848691d_69931411-29a4-40a4-aa84-fe522d49cdf5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat Dimethyl propylphosphonate,18755-43-6,Valid studies for acute oral toxicity according OECD 401 and acute inhalation toxicity according OECD 403 are available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53e50fbb-f07b-4e58-a1ae-700a794fcc67/documents/IUC5-6e625db6-318d-47c4-a846-ae23506d0853_69931411-29a4-40a4-aa84-fe522d49cdf5.html,,,,,, Dimethyl propylphosphonate,18755-43-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53e50fbb-f07b-4e58-a1ae-700a794fcc67/documents/IUC5-6e625db6-318d-47c4-a846-ae23506d0853_69931411-29a4-40a4-aa84-fe522d49cdf5.html,,oral,LD50,"2,001 mg/kg bw",adverse effect observed, Dimethyl propylphosphonate,18755-43-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53e50fbb-f07b-4e58-a1ae-700a794fcc67/documents/IUC5-6e625db6-318d-47c4-a846-ae23506d0853_69931411-29a4-40a4-aa84-fe522d49cdf5.html,,inhalation,discriminating conc.,"5,788 mg/m3",adverse effect observed, Dimethyl terephthalate,120-61-6,"A number of studies are consistent in demonstrating the low toxicity of DMT following repeated oral exposure. Marked effects (including mortality) were only seen at very high dietary dose levels at which food consumption was adversely affected due to poor dietary palatability. No dermal data are available, however low toxicity can be reliably predicted for DMT. The results of inhalation studies are conflicting, however the findings of a more modern and reliable dust inhalation study showed only mild local effects at the highest exposure concentration. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a5098432-c8cf-48e0-ae87-77b0b221730f/documents/IUC5-a45eda61-d179-43ed-9a20-22a2c64e0b36_af6e8b92-f622-4549-9517-51309c17c6d7.html,,,,,, Dimethyl terephthalate,120-61-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a5098432-c8cf-48e0-ae87-77b0b221730f/documents/IUC5-a45eda61-d179-43ed-9a20-22a2c64e0b36_af6e8b92-f622-4549-9517-51309c17c6d7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Dimethyl terephthalate,120-61-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a5098432-c8cf-48e0-ae87-77b0b221730f/documents/IUC5-a45eda61-d179-43ed-9a20-22a2c64e0b36_af6e8b92-f622-4549-9517-51309c17c6d7.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,86.4 mg/m3,,rat Dimethyl terephthalate,120-61-6,The acute toxicity of DMT has been investigated by various routes of exposure and using various species. The substance is of very low acute toxicity by all routes investigated. Oral LD50 values of >3200->7500 mg/kg bw are reported. Dermal LD50 values of >2000->5000 mg/kg bw are reported. A 2-hour inhalation LC50 of 6 mg/L is reported. Acute intraperitoneal LD50 values 1600-3200 mg/kg bw are reported. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5098432-c8cf-48e0-ae87-77b0b221730f/documents/IUC5-0092e3d6-85db-4014-a62b-53e670846da0_af6e8b92-f622-4549-9517-51309c17c6d7.html,,,,,, Dimethyl terephthalate,120-61-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5098432-c8cf-48e0-ae87-77b0b221730f/documents/IUC5-0092e3d6-85db-4014-a62b-53e670846da0_af6e8b92-f622-4549-9517-51309c17c6d7.html,,oral,LD50,"7,500 mg/kg bw",, Dimethyl terephthalate,120-61-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5098432-c8cf-48e0-ae87-77b0b221730f/documents/IUC5-0092e3d6-85db-4014-a62b-53e670846da0_af6e8b92-f622-4549-9517-51309c17c6d7.html,,dermal,LD50,"5,000 mg/kg bw",, Dimethyl terephthalate,120-61-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5098432-c8cf-48e0-ae87-77b0b221730f/documents/IUC5-0092e3d6-85db-4014-a62b-53e670846da0_af6e8b92-f622-4549-9517-51309c17c6d7.html,,inhalation,LC50,"3,000 mg/m3",, Dimethyl vinylphosphonate,4645-32-3, The LD50 value of the test item was determined to be 858.0 mg/kg bw in males and 602 mg/kg bw in females. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91e02dab-9e9f-43ad-b716-14a3d9bfaf6c/documents/83245684-99c0-4c15-9057-e137f8e0bb59_342cee97-174c-4009-b92c-4e79233492f3.html,,,,,, Dimethyl vinylphosphonate,4645-32-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91e02dab-9e9f-43ad-b716-14a3d9bfaf6c/documents/83245684-99c0-4c15-9057-e137f8e0bb59_342cee97-174c-4009-b92c-4e79233492f3.html,,oral,LD50,602 mg/kg bw,adverse effect observed, Dimethyl(propyl)amine,926-63-6," Inhalation - OECD 422, GLP: NOAEC local = 125 mg/m³ (35ppm), NOAEC systemic = 500mg/m³ (140ppm) (BASF, 2019) - RA 598 -56 -1, OECD 412 (28 -day): NOAEC local = 10 ppm, NOAEC systemic = 50 ppm (TNO, 2019) (highest dose: 250ppm) - RA 598 -56 -1, OECD 413 (90 -day): NOAEC local = 10.3 ppm, NOAEC systemic = 106 ppm (highest dose tested) (Covance, 2020) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee09c2cc-d661-4128-b904-fbf7311c399f/documents/8a17b298-1128-4e0a-a6d1-47456afc5589_dbfc8ca8-a4cc-4d63-93ba-0ce031e4daa6.html,,,,,, Dimethyl(propyl)amine,926-63-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee09c2cc-d661-4128-b904-fbf7311c399f/documents/8a17b298-1128-4e0a-a6d1-47456afc5589_dbfc8ca8-a4cc-4d63-93ba-0ce031e4daa6.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,500 mg/m3,,rat Dimethyl(propyl)amine,926-63-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee09c2cc-d661-4128-b904-fbf7311c399f/documents/8a17b298-1128-4e0a-a6d1-47456afc5589_dbfc8ca8-a4cc-4d63-93ba-0ce031e4daa6.html,Repeated dose toxicity – local effects,inhalation,NOAEC,125 mg/m3,adverse effect observed,rat Dimethyl(propyl)amine,926-63-6," - Acute oral toxicity (rat), LD50 = 500 mg/kg bw - Acute inhalation toxicity (rat), LC50 = 4.499 mg/L air - Acute dermal toxicity (rat), LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee09c2cc-d661-4128-b904-fbf7311c399f/documents/8800fb12-c5b4-4429-9d1c-204a583a4ace_dbfc8ca8-a4cc-4d63-93ba-0ce031e4daa6.html,,,,,, Dimethyl(propyl)amine,926-63-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee09c2cc-d661-4128-b904-fbf7311c399f/documents/8800fb12-c5b4-4429-9d1c-204a583a4ace_dbfc8ca8-a4cc-4d63-93ba-0ce031e4daa6.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Dimethyl(propyl)amine,926-63-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee09c2cc-d661-4128-b904-fbf7311c399f/documents/8800fb12-c5b4-4429-9d1c-204a583a4ace_dbfc8ca8-a4cc-4d63-93ba-0ce031e4daa6.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Dimethyl(propyl)amine,926-63-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee09c2cc-d661-4128-b904-fbf7311c399f/documents/8800fb12-c5b4-4429-9d1c-204a583a4ace_dbfc8ca8-a4cc-4d63-93ba-0ce031e4daa6.html,,inhalation,LC50,"4,500 mg/m3",adverse effect observed, "dimethyl[[2,2'''-[1,3-propanediylbis(oxy-kO)]bis[3'',5,5''-tris(1,1-dimethylethyl)-5'-methyl[1,1':3',1''-terphenyl]-2'-olato-kO]](2-)]-zirconium",1001417-33-9," The acute oral median lethal dose (LD50) of the test item, as avialable on the market in a 4.6% solution, in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System: Unclassified). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9dbbc82-34e2-47e6-9211-af1b87c0be58/documents/aa230ecc-5b3b-4e9c-8baf-130f981374c8_12940c64-6075-4fde-a8db-8ada1a149b93.html,,,,,, Dimethylamine-borane (1:1),74-94-2," The acute oral LD50 value of dimethlylamine-borane in rats was reported to be 59.2 mg/kg bw in a publication by Levinskas (1955). Via the dermal route the acute LD50 value of the test item was determined to be 210.0 respectively 398.0 mg/kg bw in two different in vivo studies similar to OECD 402. In a worst case approach, a dermal LD50 value of 210 mg/kg bw is assumed. In a review article by Roush (1959) an intraperitoneal LD50 value of dimethylamine-borane in rats of 50.0 mg/kg bw has been reported. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c7ee421-2e2b-402e-b2b5-de3046db3c24/documents/1cc4df80-ca74-4eea-b226-76d68a39f784_211a8310-e145-483e-a3b4-084aaa5c66ae.html,,,,,, Dimethylamine-borane (1:1),74-94-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c7ee421-2e2b-402e-b2b5-de3046db3c24/documents/1cc4df80-ca74-4eea-b226-76d68a39f784_211a8310-e145-483e-a3b4-084aaa5c66ae.html,,oral,LD50,59.2 mg/kg bw,adverse effect observed, Dimethylamine-borane (1:1),74-94-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c7ee421-2e2b-402e-b2b5-de3046db3c24/documents/1cc4df80-ca74-4eea-b226-76d68a39f784_211a8310-e145-483e-a3b4-084aaa5c66ae.html,,dermal,LD50,210 mg/kg bw,adverse effect observed, "Dimethylammonium 2,4-dichlorophenoxyacetate",2008-39-1,"Key, Charles, 1996, 90 d, rats, RL1 - NAEL 15 mg/kg bw/d Charles, 1996, 90 d, dog, RL1- NOAEL 1 mg/kg bw/d ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f35bf5e4-70cd-47f3-947e-6c01f9097e57/documents/IUC5-2a224475-c22a-412f-9025-63187b6aa34d_b1c8a44f-682b-494b-a853-c6d6dbe0b9aa.html,,,,,, "Dimethylammonium 2,4-dichlorophenoxyacetate",2008-39-1,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f35bf5e4-70cd-47f3-947e-6c01f9097e57/documents/IUC5-2a224475-c22a-412f-9025-63187b6aa34d_b1c8a44f-682b-494b-a853-c6d6dbe0b9aa.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "Dimethylammonium 2,4-dichlorophenoxyacetate",2008-39-1,"The following information is taken into account for any hazard / risk assessment:Oral ToxicityKey, Kita, 1997, Aminopielik 720, rat, acute oral, RL1 – LD50 = 555 mg/kg bw (based on an active ingredient content of 72.6% and a LD50 of 764 mg/kg bw observed in the respective study)Kita, 1991, Aminopielik 600, rat, acute oral, RL1 – LD50 = 685 mg/kg bw (based on an active ingredient content of 51.6% and a LD50 of 994 mg/kg bw observed in the respective study) Inhalative ToxicityKey, Rydzynski and Swiercz, 1998, Aminopielik 600, rat, acute inhal., RL1 – LC50 >3080 mg/m³ air (females) and 3258 mg/m³ air (males) (based on an active ingredient content of 60.6% and doses of 5083 mg/m³ air (females) and 5377 mg/m³ air (males) used in the respective study)Dermal toxicityKey, Kita, 1997, Aminopielik 720, rat, acute dermal, RL2 - LD50 > 1452 mg/kg bw (based on an active ingredient content of 72.6% and a test concentration of 2000 mg/kg bw used in the respective study)Kita, 1991, Aminopielik 600, rat, acute dermal, RL1 - LD50 = 4745 mg/kg bw (based on an active ingredient content of 51.6% and a test concentration of 6536 mg/kg bw used in the respective study) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f35bf5e4-70cd-47f3-947e-6c01f9097e57/documents/IUC5-49bdf79a-c174-4924-83fd-3581ea3572ea_b1c8a44f-682b-494b-a853-c6d6dbe0b9aa.html,,,,,, Dimethylammonium chloride,506-59-2,"No studies for Dimethylammonium chloride are available.   However, there are some studies available for the close analogue Dimethylamine: Oral: BASF, Gewerbetoxikologische Grundprüfung, 1980. Inhalation: BASF, Bericht ueber die Bestimmung der akuten Inhalationstoxizitaet LC50 von Dimethylamin Gas bei 4-stuendiger Exposition an Sprague-Dawley-Ratten, 1979.Dermal: BASF, Gewerbetoxikologische Grundprüfung, 1980. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fb59c58-a737-46f9-ab70-c1e81d1de651/documents/484053af-35b3-4d18-8f89-7cb140c8e6ff_f5a72311-8662-48f1-ad88-58d6591f4892.html,,,,,, Dimethylammonium chloride,506-59-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fb59c58-a737-46f9-ab70-c1e81d1de651/documents/484053af-35b3-4d18-8f89-7cb140c8e6ff_f5a72311-8662-48f1-ad88-58d6591f4892.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, Dimethylammonium chloride,506-59-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fb59c58-a737-46f9-ab70-c1e81d1de651/documents/484053af-35b3-4d18-8f89-7cb140c8e6ff_f5a72311-8662-48f1-ad88-58d6591f4892.html,,dermal,LD50,"3,900 mg/kg bw",no adverse effect observed, Dimethylbis(oleoyloxy)stannane,3865-34-7," Repeated Dose Toxicity Oral: Read-across to DMTC (Dimethyltin dichloride CAS No. 753 -73 -1) - Appel (2000): 90 day  NOAEL (rats) = 15 ppm (equivalent to 0.62 and 0.65 mg/kg/day for males and females, respectively, when adjusted for DMTC purity). Neurotoxicity at 200 ppm - Beyrouty (1997): 90 day LOAEL (rats) = 25 ppm (equivalent to 1.44 and 1.98 mg/kg bw/day for males and female, respectively, when adjusted for DMTC purity). Reduced food (males only) and water intake and neuropathological lesions. Vacuolisation of white matter in the brain and spinal cord was also observed for animals in the 25 ppm group. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6957f692-c5e3-4ed5-87aa-fe054520a9f9/documents/f1e60c25-5e8e-48d3-b902-7436ed039e9e_43f4a92c-f855-4cd8-9bc5-f9ea6e57bca7.html,,,,,, Dimethylbis(oleoyloxy)stannane,3865-34-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6957f692-c5e3-4ed5-87aa-fe054520a9f9/documents/f1e60c25-5e8e-48d3-b902-7436ed039e9e_43f4a92c-f855-4cd8-9bc5-f9ea6e57bca7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.62 mg/kg bw/day,,rat Dimethylbis(oleoyloxy)stannane,3865-34-7," Acute Oral: Key: DMT-OI (CAS 3865 -34 -7) LD50 - Females = 300-2000 mg/kg bw. Cut-off value = 500 mg/kg bw (van de Wiel, 2020) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6957f692-c5e3-4ed5-87aa-fe054520a9f9/documents/6dfba4e3-5c11-45cc-8a24-bdac26b54f0f_43f4a92c-f855-4cd8-9bc5-f9ea6e57bca7.html,,,,,, Dimethylbis(oleoyloxy)stannane,3865-34-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6957f692-c5e3-4ed5-87aa-fe054520a9f9/documents/6dfba4e3-5c11-45cc-8a24-bdac26b54f0f_43f4a92c-f855-4cd8-9bc5-f9ea6e57bca7.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Dimethylbis[(1-oxoneodecyl)oxy]stannane,68928-76-7," Repeated Dose Toxicity Oral: Read-across to DMTC (Dimethyltin dichloride CAS No. 753 -73 -1) - Appel (2000): 90 day  NOAEL (rats) = 15 ppm (equivalent to 0.62 and 0.65 mg/kg/day for males and females, respectively, when adjusted for DMTC purity). Neurotoxicity at 200 ppm - Beyrouty (1997): 90 day LOAEL (rats) = 25 ppm (equivalent to 1.44 and 1.98 mg/kg bw/day for males and female, respectively, when adjusted for DMTC purity). Reduced food (males only) and water intake and neuropathological lesions. Vacuolisation of white matter in the brain and spinal cord was also observed for animals in the 25 ppm group. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2be68be1-14c4-4523-876e-20f592209574/documents/83b3f5d3-68c8-41dc-a21c-115c32417ea1_99c7ce24-10fa-48ba-ad0a-6f4fa4e5294b.html,,,,,, Dimethylbis[(1-oxoneodecyl)oxy]stannane,68928-76-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2be68be1-14c4-4523-876e-20f592209574/documents/83b3f5d3-68c8-41dc-a21c-115c32417ea1_99c7ce24-10fa-48ba-ad0a-6f4fa4e5294b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.62 mg/kg bw/day,,rat Dimethylbis[(1-oxoneodecyl)oxy]stannane,68928-76-7," Acute Oral: Koch (2001) Under the conditions of this study, when the test material was administered by gavage to rats, the acute oral LD50 was determined to be 894 mg/kg with 95% confidence limits of 691-1156 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2be68be1-14c4-4523-876e-20f592209574/documents/a9306407-9606-4240-be3c-b63eb6726beb_99c7ce24-10fa-48ba-ad0a-6f4fa4e5294b.html,,,,,, Dimethylbis[(1-oxoneodecyl)oxy]stannane,68928-76-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2be68be1-14c4-4523-876e-20f592209574/documents/a9306407-9606-4240-be3c-b63eb6726beb_99c7ce24-10fa-48ba-ad0a-6f4fa4e5294b.html,,oral,LD50,894 mg/kg bw,adverse effect observed, Dimethyldioctylammonium chloride,5538-94-3," No studies are available to assess the repeated dose toxicity of the substance following oral administration. However, there is one reliable sub-chronic oral study in rats and two chronic studies in rats and mice available for a structurally similar substance. Treatment of rats with the substance at a concentration of 1000 ppm or less for 13-weeks in a dietary study resulted in a no treatment-related difference in any measurements and thus the NOEL for the substance for this strain of rats is considered to be 1000 ppm. Dietary administration of the substance resulted in treatment-related decreases in body weight and food consumption in both male and female rats in the high dose group (1500 ppm). At 1500 ppm, hyperplasia of bile ducts in females and changes in mesenteric lymph nodes of males and females related to blood in the sinuses. There were no other treatment-related changes observed and this formed the basis for a NOAEL of 750 ppm (equivalent to 32 mg/kg bw/day in males and 41 mg/kg bw/day in females). No treatment-related changes, which could be considered adverse, were observed in male and female mice following dosing with the substance, when administered in powdered rodent diet for at least 78 weeks at the approximate concentrations of 100, 500 or 1000 ppm (corresponding to mean intake dose levels of 15, 76.3 and 155.5 mg/kg bw/day for the males and 18.6, 93.1 and 193.1 mg/kg bw/day for the females).The NOEL identified in this study was 500 ppm based on reduced weight and reduced weight gain in both sexes. In a subacute toxicity study the substance was administered to male and female (2/sex/dose) rabbits (strain unspecified) by dermal application levels of 0.00025, 0.001 and 0.002% of a 100% active solution. At no time during the study were there any aberrations in food or fluid intake, excretions, appearance or behaviour noted. All blood and urine findings were within normal limits. Gross and histopathological examinations of significant organs and tissues were all unremarkable. The NOEL is identified to 0.002%. However, this study cannot be used for deriving DNELs because it is rated as Klimisch 4 (unreliable). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f107dbfa-3b2f-4ce7-a216-89c4ba355073/documents/0f855f3b-b388-47f0-a2eb-2b9d431d3599_1404e2fe-c7b9-4807-a23a-ff7167b437b4.html,,,,,, Dimethyldioctylammonium chloride,5538-94-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f107dbfa-3b2f-4ce7-a216-89c4ba355073/documents/0f855f3b-b388-47f0-a2eb-2b9d431d3599_1404e2fe-c7b9-4807-a23a-ff7167b437b4.html,Chronic toxicity – systemic effects,oral,NOAEL,32 mg/kg bw/day,,rat Dimethyldioctylammonium chloride,5538-94-3," In an unreliable acute oral toxicity study the substance was administered to mice (10 animals/dose) by oral gavage at a dose level of 375 mg/kg bw (single administration). Fifty percent of the animals died within 24 hours of treatment. Haemorrhages in stomach and intestine with pneumonia were observed during gross pathology. The oral LD50 in mice is 375 mg/kg bw. In a reliable acute toxicity study, a structurally similar substance was administered to Sprague Dawley rats (5 animals/sex/dose) by oral gavage at a dose level of 500, 300, 200 or 100 mg/kg bw (single administration). Mortalities were observed at all dose groups except for in the 100 mg/kg bw group. The most prevalent clinical changes for all dose groups noted during the observation period included urine and fecal stains, saliva discharge and stains, dried red stains on muzzle and around eyes, eye squinting, piloerection, ataxia, body tremors, laboured and shallow respiration, slight to severe depression, viscous red blood like discharge from mouth, bloated appearance to the abdomen, and spasms in the abdominal area. The most common abnormalities found at macroscopic post-mortem examination included effects in the liver, kidneys, stomach, intestines and the spleen. The oral LD50 is 238 mg/kg bw. In an unreliable acute inhalation toxicity study the substance was administered to mice (5 animals/sex/dose) by inhalation at a concentration of 10 mg/L air for 1 hour. No animals died. The inhalation LD50 in rats is >10 mg/L air. There are four acute dermal toxicity studies for the substance in the rabbit. The LD50s were 259 mg/kg bw, 1.51 ml/kg bw, 247 mg/kg bw (liquid) and 191 mg/kg bw (solid). The most prevalent clinical sign of toxicity across all studies was eschar formation and the solid form of the substance was found to produce less severe toxic effects compared with the liquid form. In one study the dermal administration of the substance resulted in the animals going into physiological decline and all died within 96 hours of exposure. In an acute dermal toxicity study a structurally similar substance was administered to New Zealand White rabbits (5 animals/sex/dose) by occlusive dressing at dose levels of 552, 1104, 3328 or 4448 mg/kg bw (single administration). A decrease in mean body weight was observed in all treatment groups in a dose response relationship. There was an increased incidence of pale kidneys in animals at the highest treatment level as compared to controls. Distended atria and/or ventricles were also noted in three animals at the highest dose levels. One animal in the 3328 mg/kg bw treatment group was noted to have a heavily pigmented gel in the large intestine. The acute dermal toxicity of the substance is 3342 mg/kg bw in the rabbit. The substance was a corrosive as evidenced by adverse signs at the site of application. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f107dbfa-3b2f-4ce7-a216-89c4ba355073/documents/eb9151e8-66e3-4df4-8e2b-7342623f0700_1404e2fe-c7b9-4807-a23a-ff7167b437b4.html,,,,,, Dimethyldioctylammonium chloride,5538-94-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f107dbfa-3b2f-4ce7-a216-89c4ba355073/documents/eb9151e8-66e3-4df4-8e2b-7342623f0700_1404e2fe-c7b9-4807-a23a-ff7167b437b4.html,,oral,LD50,238 mg/kg bw,adverse effect observed, Dimethyldioctylammonium chloride,5538-94-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f107dbfa-3b2f-4ce7-a216-89c4ba355073/documents/eb9151e8-66e3-4df4-8e2b-7342623f0700_1404e2fe-c7b9-4807-a23a-ff7167b437b4.html,,dermal,LD50,191 mg/kg bw,adverse effect observed, Dimethyldioctylammonium chloride,5538-94-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f107dbfa-3b2f-4ce7-a216-89c4ba355073/documents/eb9151e8-66e3-4df4-8e2b-7342623f0700_1404e2fe-c7b9-4807-a23a-ff7167b437b4.html,,inhalation,LC50,10 mg/m3,no adverse effect observed, Dimethyloctadecyl(3-sulphopropyl)ammonium hydroxide,13177-41-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30b184c0-20b6-4a71-818b-1fac12a3e415/documents/bf3d4e9a-81c8-4c0c-94eb-26742ceed491_34a4554f-fe86-477a-aebd-8f7553d5200f.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride,27668-52-6," Repeated dose toxicity oral: Repeated oral toxicity test was performed By Siddiqui and York (1993) in virgin female Sprague-Dawley derived Charles River CD rats using different concentrations of Quaternary Silsequioxane as 0,100, 300 or 1000 mg/kg/day. Adult virgin female Sprague-Dawley rats were taken, mated with male and evidence of mating was detected and designated as Day 0 of gestation. Including control in all groups 25 rats were taken for treatment at each dose level. Doses were given orally from Days 6 through 15 at a constant volume of 10 ml/kg. Mortality, clinical signs, organ weight and fetuses were observed in maternal rats. No mortality was observed in study, no changes in clinical signs and behavior were observed. Mean body weight gains and feed consumption in treated animals were not affected during the study when compared to those of the control group. A slight but significant increase in relative liver-to- body- weight ratio was observed at the 1000 mg/kg/day dose level. Based on the result observed for maternal rats on mortality, clinical signs and Organ weight it was determined that the Quaternary Silsesquioxane (27668-52-6) has a No Observed Adverse Effect Level (NOAEL) of 300 mg /kg/day concentration. Repeated dose toxicity dermal: Repeated dose dermal toxicity study was performed to determine the dermal toxic nature of N,N-dimethyl-N-[3-(trimethoxysilyl)propyl]octadecan-1-aminium chloride using Sustainability Support Services Quantitative Structure Activity Relation prediction database, 2017. The study assumed the use of male and female New Zealand White rabbits in a subchronic study performed. The No Observed Adverse Effect Level (NOAEL) for N,N-dimethyl-N-[3-(trimethoxysilyl)propyl]octadecan-1-aminium chloride is found to be 792.0 mg/Kg bw/day using New Zealand White rabbits and hence is predicted to not classify as a toxicant by repeated dermal route of exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e7e0069-afad-4d5a-b84f-97f3dc54494a/documents/3dc4e45a-6f99-4ce3-a607-54bab02c1f0b_ea09df9b-f1dc-4ba8-8445-47c3ad36c6bc.html,,,,,, Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride,27668-52-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e7e0069-afad-4d5a-b84f-97f3dc54494a/documents/3dc4e45a-6f99-4ce3-a607-54bab02c1f0b_ea09df9b-f1dc-4ba8-8445-47c3ad36c6bc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride,27668-52-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e7e0069-afad-4d5a-b84f-97f3dc54494a/documents/3dc4e45a-6f99-4ce3-a607-54bab02c1f0b_ea09df9b-f1dc-4ba8-8445-47c3ad36c6bc.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,792 mg/kg bw/day,,rabbit Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride,27668-52-6," Acute oral toxicity:    The acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.   Acute Inhalation Toxicity:   The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 5.8 x10-14 mm Hg = 0.0000000000077 Pascal. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity:   The acute dermal toxicity dose (LD50) was considered based on study conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e7e0069-afad-4d5a-b84f-97f3dc54494a/documents/e07ca99e-a27d-4326-800f-f9d454b31eb6_ea09df9b-f1dc-4ba8-8445-47c3ad36c6bc.html,,,,,, Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride,27668-52-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e7e0069-afad-4d5a-b84f-97f3dc54494a/documents/e07ca99e-a27d-4326-800f-f9d454b31eb6_ea09df9b-f1dc-4ba8-8445-47c3ad36c6bc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dimethyloctadecyl[3-(trimethoxysilyl)propyl]ammonium chloride,27668-52-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e7e0069-afad-4d5a-b84f-97f3dc54494a/documents/e07ca99e-a27d-4326-800f-f9d454b31eb6_ea09df9b-f1dc-4ba8-8445-47c3ad36c6bc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dimolybdenum carbide,12069-89-5,"A GLP guideline study according to OECD 408 was conducted. Based on effects on body weight, body weight gain, food conversion efficiency and renal histopathology (females only) at 60 mg Mo/kg bw/day the NOAEL for both sexes is considered to be 17 mg Mo/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92008f81-09bf-4800-9212-3a9056956ecd/documents/2cd582a0-de7a-48bf-abc8-a658a7246dd4_39c90918-d33a-43aa-b627-1858cdca2cca.html,,,,,, Dimolybdenum carbide,12069-89-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92008f81-09bf-4800-9212-3a9056956ecd/documents/2cd582a0-de7a-48bf-abc8-a658a7246dd4_39c90918-d33a-43aa-b627-1858cdca2cca.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat Dimolybdenum carbide,12069-89-5,"In an acute oral toxicity study (OECD 401) young adult Crl:CD (SD) rats (5 animals per sex and dose) were orally exposed to Sodium molybdate in corn oil at concentrations of 3200, 5000 and 6400 mg/kg bw.  Mortality occured within the different dose groups. The oral LD50 for both sexes was considered to be 4233 mg/kg body weight. In an acute inhalation toxicity study equivalent to OECD 403, groups of young male and female Sprague-Dawley rats (5 per sex) were exposed via the inhalation route to Sodium Molybdate (99.7% a.i.) for 4 hours to the whole body at a mean concentration of 1.93 mg/L. No mortality or distinct clinical signs were observed after exposure to Sodium Molybdate. The LC50 for both sexes was considered to be greater than 1.93 mg/L. In an acute dermal toxicity study (OECD 402, limit test), a group of young adult Crl:CD (SD) rats (5 animals per sex) was dermally exposed to Sodium molybdate in water for 24 hours to approximately 10% of body surface area at 2000 mg/kg bw. Animals were observed for 14 days. No mortality occurred and the LD50 was considered to exceed 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92008f81-09bf-4800-9212-3a9056956ecd/documents/2128996a-5a5c-4b1a-b2c8-98544b0ad96c_39c90918-d33a-43aa-b627-1858cdca2cca.html,,,,,, Dimolybdenum carbide,12069-89-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92008f81-09bf-4800-9212-3a9056956ecd/documents/2128996a-5a5c-4b1a-b2c8-98544b0ad96c_39c90918-d33a-43aa-b627-1858cdca2cca.html,,oral,LD50,"2,095 mg/kg bw",adverse effect observed, Dimolybdenum trizinc nonaoxide,22914-58-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Reliable study available ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30cc966f-2729-449c-81fe-62652c02dfd4/documents/86351381-b477-41f4-84c0-07ff0d7fbf77_45189da4-880a-4e8f-8541-610055c314b8.html,,,,,, Dimolybdenum trizinc nonaoxide,22914-58-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30cc966f-2729-449c-81fe-62652c02dfd4/documents/86351381-b477-41f4-84c0-07ff0d7fbf77_45189da4-880a-4e8f-8541-610055c314b8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat Dimolybdenum trizinc nonaoxide,22914-58-5, Two reliable acute toxicity studies are available by the oral and inhalation routes of exposure. These were conducted in accordance with GLP and OECD Guidelines. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30cc966f-2729-449c-81fe-62652c02dfd4/documents/19742128-a112-4827-bfe8-7a09e14d8621_45189da4-880a-4e8f-8541-610055c314b8.html,,,,,, "Dinaphtho[1,2,3-cd:3',2',1'-lm]perylene-5,10-dione, (9,10-dihydro-9,10-dioxo-1-anthracenyl)amino derivs.",90342-37-3,The acute oral LD50 of FAT 45082 in rats of both sexes observed over a period of 14 days is >5000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71611ccb-5050-4aa4-b84f-02f2c18a0864/documents/IUC5-45f8c0f7-958f-4467-88df-380cdfb284d1_f58e30a5-159b-4d72-ae71-ac1bc08913a7.html,,,,,, "Dinaphtho[1,2,3-cd:3',2',1'-lm]perylene-5,10-dione, (9,10-dihydro-9,10-dioxo-1-anthracenyl)amino derivs.",90342-37-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71611ccb-5050-4aa4-b84f-02f2c18a0864/documents/IUC5-45f8c0f7-958f-4467-88df-380cdfb284d1_f58e30a5-159b-4d72-ae71-ac1bc08913a7.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Dineodymium tricarbonate,5895-46-5,"A fully compliant OECD 422 study is available, performed using dicerium tricarbonate as the test substance. Reading-across from this similar substance, the study has been considered as the key study for evaluating the repeated dose toxicity of dineodymium tricarbonate.Repeat dose studies via the dermal and inhalation routes have been waived. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e471655e-1eee-4c26-8b96-7fd69bc3bf4b/documents/IUC5-c049ed53-5624-4214-a3c7-c8d8fc8dc05a_7e210050-2f3b-4e5d-bc53-10f013d89e74.html,,,,,, Dineodymium tricarbonate,5895-46-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e471655e-1eee-4c26-8b96-7fd69bc3bf4b/documents/IUC5-c049ed53-5624-4214-a3c7-c8d8fc8dc05a_7e210050-2f3b-4e5d-bc53-10f013d89e74.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat Dineodymium tricarbonate,5895-46-5,"ORAL EPOSURE:  One acute oral fixed dose study according to OECD 420 and EU B.1 bis acute oral toxicity guidelines.DERMAL EXPOSURE: no specific test data available; this endpoint is waived.INHALATION EXPOSURE:  One acute inhalation study according to OECD 403 is available, performed with Lanthancarbonate-octahydrate (read-across) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e471655e-1eee-4c26-8b96-7fd69bc3bf4b/documents/IUC5-bd764f51-2261-4c9e-9de1-e0a5143bff3e_7e210050-2f3b-4e5d-bc53-10f013d89e74.html,,,,,, Dineodymium tricarbonate,5895-46-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e471655e-1eee-4c26-8b96-7fd69bc3bf4b/documents/IUC5-bd764f51-2261-4c9e-9de1-e0a5143bff3e_7e210050-2f3b-4e5d-bc53-10f013d89e74.html,,oral,discriminating dose,"2,000 mg/kg bw",, Dineodymium tricarbonate,5895-46-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e471655e-1eee-4c26-8b96-7fd69bc3bf4b/documents/IUC5-bd764f51-2261-4c9e-9de1-e0a5143bff3e_7e210050-2f3b-4e5d-bc53-10f013d89e74.html,,inhalation,discriminating conc.,"5,928 mg/m3",, Dinitrogen tetraoxide,10544-72-6,"Based on read-across from a monomer of dinitrogen tetraoxide, NO2, the substance causes adverse effects in lungs after respiratory exposure. In the available 90 -day repeated dose toxicity study performed according to modern standards, no adverse systemic or local effects were observed at the highest tested dose of 2.5 ppm. SCOEL (2014) concluded that the level of 0.5 ppm (0.955 mg/m3) as 8 -h TWA is considered sufficient to protect against adverse respiratory effects by repeated exposure. As dinitrogen tetraoxide represents a dimer of nitrogen dioxide, one mole of dinitrogen tetraoxide will generate two moles of nitrogen dioxide. Therefore based on molar ratio for dinitrogen tetraoxide the 8-h TWA IOEL was recalculated to 0.25 ppm by the registrant, which is equal to 0.955 mg/m3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b15e833-0614-4240-8274-f2e4fca96b0d/documents/d4cf2ca1-504c-43da-87aa-339f0362a4f8_528debb1-7de3-449d-85a7-2e0da1b0e185.html,,,,,, Dinitrogen tetraoxide,10544-72-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b15e833-0614-4240-8274-f2e4fca96b0d/documents/d4cf2ca1-504c-43da-87aa-339f0362a4f8_528debb1-7de3-449d-85a7-2e0da1b0e185.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,4.36 mg/m3,,rat Dinitrogen tetraoxide,10544-72-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b15e833-0614-4240-8274-f2e4fca96b0d/documents/d4cf2ca1-504c-43da-87aa-339f0362a4f8_528debb1-7de3-449d-85a7-2e0da1b0e185.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4.36 mg/m3,adverse effect observed,rat Dinitrogen tetraoxide,10544-72-6," Based upon a review of the available data the following effect level has been chosen for acute toxicity: inhalation:LC50 (rat) at 60 mins for nitrogen dioxide: 115 ppm.The modification of exposure duration to 4-hour exposure using Haber's law results in the 4-h LC50 for nitrogen dioxide of 28.8 ppm, or 55 mg/m3. Considering one mole dinitrogen tetraoxide results in the formation of two moles of nitrogen dioxide, this value was recalculated to 14.4 ppm by the registrant, which is equal to 55 mg/m3 , for dinitrogen tetraoxide. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b15e833-0614-4240-8274-f2e4fca96b0d/documents/f971b7fc-2f05-45c3-b47e-389f1989cc06_528debb1-7de3-449d-85a7-2e0da1b0e185.html,,,,,, Dinitrogen tetraoxide,10544-72-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b15e833-0614-4240-8274-f2e4fca96b0d/documents/f971b7fc-2f05-45c3-b47e-389f1989cc06_528debb1-7de3-449d-85a7-2e0da1b0e185.html,,inhalation,LC50,55 mg/m3,adverse effect observed, Dinonylnaphthalenedisulphonic acid,60223-95-2,"A repeated dose reproduction toxicity study is available on an analogue, DNNSA. For DNNSA local effects in the gastro-intestinal tract were the primary finding (due to the acidic nature of the test material) with concomitant reduced body weight (NOAEL 95 mg/kg bw). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf840813-2e16-4e5f-ab4b-d5ddda99aa31/documents/IUC5-a8b646f2-f5d6-452d-8cd6-4204b1d61fe7_41f3dd3f-b8f6-4cf5-b779-51d93714bc66.html,,,,,, Dinonylnaphthalenedisulphonic acid,60223-95-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf840813-2e16-4e5f-ab4b-d5ddda99aa31/documents/IUC5-a8b646f2-f5d6-452d-8cd6-4204b1d61fe7_41f3dd3f-b8f6-4cf5-b779-51d93714bc66.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,95 mg/kg bw/day,,rat Dinonylnaphthalenedisulphonic acid,60223-95-2,"Groups of rats (5/sex/dose) received a single dose of the test substance at 2000, 3000, 4000, 4500 and 5000 mg/kg bw (PSL 1978). In all groups mortality was reported. Necropsy showed degeneration and necrosis of the stomach as well as liver discoloration in several dead rats. The LD50 is 2035 mg/kg bw.In a very limited reported inhalation study the LD50 found in rats was > 110 mg/L (PSL 1978)Rabbits (5/sex) were dermally exposed to the test substance for 24 hours (PSL 1977). No effects other than slight erythema and well defined oedema (not observed after day 9) were reported. Body weight gain was considered normal. Necropsy did not reveal any findings. The LD50 is > 1100 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf840813-2e16-4e5f-ab4b-d5ddda99aa31/documents/IUC5-8e76e8ce-1cc3-40ad-a634-132c3c35cc4e_41f3dd3f-b8f6-4cf5-b779-51d93714bc66.html,,,,,, Dinonylnaphthalenedisulphonic acid,60223-95-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf840813-2e16-4e5f-ab4b-d5ddda99aa31/documents/IUC5-8e76e8ce-1cc3-40ad-a634-132c3c35cc4e_41f3dd3f-b8f6-4cf5-b779-51d93714bc66.html,,oral,LD50,"2,035 mg/kg bw",adverse effect observed, Dinonylnaphthalenedisulphonic acid,60223-95-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf840813-2e16-4e5f-ab4b-d5ddda99aa31/documents/IUC5-8e76e8ce-1cc3-40ad-a634-132c3c35cc4e_41f3dd3f-b8f6-4cf5-b779-51d93714bc66.html,,dermal,LD50,"1,100 mg/kg bw",no adverse effect observed, Dioctadecyl disulphide,2500-88-1,"After dosing rats (50 males and 50 females per dose group) with 0.6, 1.2 or 2.4% of the test item in diet for 130 weeks increased neutrophil counts, relative weights of liver, spleen and ovaries combined with microscopic changes in these organs were observed. These abnormalities were generally more pronounced in the low and mid dose groups than in the high dose group in both sexes. All effects might be caused by the reported deposition and storage of a unknown compound resulting in inflammatory reactions, characterised by multinucleated giant cells and they are considered to be of secondary nature generated by an overload of the test animals metabolism/excretion capacity. Therefore, the NOAEL is consiedered to be 0.6% (corrsponding to 300 mg/kg bw/d, considering a diet conversion factor (ppm to mg/kg bw/d) of 20 for older rats).  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04178546-8433-43e7-8844-04f99a127c34/documents/IUC5-f489169a-9edb-413a-8aff-ec435a46546f_172674ea-78e4-404e-99fc-7d2aff53f36f.html,,,,,, Dioctadecyl disulphide,2500-88-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04178546-8433-43e7-8844-04f99a127c34/documents/IUC5-f489169a-9edb-413a-8aff-ec435a46546f_172674ea-78e4-404e-99fc-7d2aff53f36f.html,Chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Dioctadecyl disulphide,2500-88-1,"Acute toxicity after single oral application was tested in female rats, which received 15,000 mg/kg bw. No animal died or showed clinical symptoms/macroscopic anomalies. The necropsy did not reveal any effect. The LD50 value for acute oral toxicity was considered to be greater than 15,000 mg/kg bw. Due to the findings described above (LD50 oral in rats greater than 15,000 mg/kg bw) dioctadecyl disulphide does not have to be classified as acute orally toxic. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04178546-8433-43e7-8844-04f99a127c34/documents/IUC5-4a2a246a-c212-4ab0-a27a-73ebabbc7e22_172674ea-78e4-404e-99fc-7d2aff53f36f.html,,,,,, Dioctadecyl disulphide,2500-88-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04178546-8433-43e7-8844-04f99a127c34/documents/IUC5-4a2a246a-c212-4ab0-a27a-73ebabbc7e22_172674ea-78e4-404e-99fc-7d2aff53f36f.html,,oral,LD50,"15,000 mg/kg bw",adverse effect observed, Dioctanoyl peroxide,762-16-3, The oral LD50 is > 5000 mg/kg bw. no further information available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13dd2c29-c761-4833-a063-99a2ff7bc77a/documents/2e6ffe7e-48be-4988-aaec-57dd34a05acf_5cf3aacf-5260-4d30-bae7-ed7fb1513441.html,,,,,, Dioctyl phosphonate,1809-14-9, NOAEL test item (repeated oral toxicity male and females rats treated at least 31 days)= 300 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e681de8-d31b-42e1-a4a7-71e1f9f32dbf/documents/e77f7cb6-83a4-47d1-88bb-67ed1afc925f_8c49070d-bb60-43b9-aff5-6b58c62b4dec.html,,,,,, Dioctyl phosphonate,1809-14-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e681de8-d31b-42e1-a4a7-71e1f9f32dbf/documents/e77f7cb6-83a4-47d1-88bb-67ed1afc925f_8c49070d-bb60-43b9-aff5-6b58c62b4dec.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Dioctyl phosphonate,1809-14-9, LD50 rat oral route (males/females) > 2000 mg/kg bw LD50 rat dermal route (males/females) > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e681de8-d31b-42e1-a4a7-71e1f9f32dbf/documents/9bc067a1-ab44-4ace-8858-879e5fd796e0_8c49070d-bb60-43b9-aff5-6b58c62b4dec.html,,,,,, Dioctyl sebacate,2432-87-3," Acute oral toxicity In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the acute oral toxicity was estimated for 1,10-dioctyl decanedioate (2432-87-3),LD50 was estimated to be 3746.86 mg/kg bw, when male and female Albino ratswereexposed with 1,10-dioctyl decanedioate (2432-87-3)orally. Acute dermal toxicity In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the acute dermal toxicity was estimated for 1,10-dioctyl decanedioate (2432-87-3),LD50 was estimated to be 2916.16mg/kg bw. When male and female albino rabbits were exposed with 1,10-dioctyl decanedioate (2432-87-3)by dermal application. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc35d36a-9427-4a3c-ba8d-f8ab144f7882/documents/9fdfdf56-7512-469b-b8fc-f492a410167b_0f141257-49b2-4a86-ad02-282f7b0e5713.html,,,,,, Dioctyl sebacate,2432-87-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc35d36a-9427-4a3c-ba8d-f8ab144f7882/documents/9fdfdf56-7512-469b-b8fc-f492a410167b_0f141257-49b2-4a86-ad02-282f7b0e5713.html,,oral,LD50,"3,746.86 mg/kg bw",no adverse effect observed, Dioctyl sebacate,2432-87-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc35d36a-9427-4a3c-ba8d-f8ab144f7882/documents/9fdfdf56-7512-469b-b8fc-f492a410167b_0f141257-49b2-4a86-ad02-282f7b0e5713.html,,dermal,LD50,"2,916.16 mg/kg bw",no adverse effect observed, Dioctyltin dilaurate,3648-18-8,"ORALWaalkens-Berendsen (2004), OECD 422, NOAEL 5 mg/kg diet (based on the effects noted in the thymus) equivalent to 0.3-0.4 mg/kg bw/day for male animals and 0.3-0.5 mg/kg bw/day for female animals, performed on the read across substance dioctyltin oxide (DOTO). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5698044-6658-4b55-83a7-fb032fc52bff/documents/IUC5-0ae8a3ff-6064-4fb4-a3f9-59d049b64ba3_e73380c8-5ea8-43be-b1d8-10bd6a5e14e4.html,,,,,, Dioctyltin dilaurate,3648-18-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5698044-6658-4b55-83a7-fb032fc52bff/documents/IUC5-0ae8a3ff-6064-4fb4-a3f9-59d049b64ba3_e73380c8-5ea8-43be-b1d8-10bd6a5e14e4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,0.3 mg/kg bw/day,,rat Dioctyltin dilaurate,3648-18-8,"OralLD50 > 2000 mg/kg bw, rat (female), OECD 423, EU Method B.1 tris. Dreher (2013) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5698044-6658-4b55-83a7-fb032fc52bff/documents/IUC5-9b2e5d35-de70-4e63-91f1-a38ab88e3826_e73380c8-5ea8-43be-b1d8-10bd6a5e14e4.html,,,,,, Dioctyltin oxide,870-08-6,"OECD TG 443 (Barraclough, 2020), GLP, rat, oral via diet, F0 generation treated for up to 127 days, NOAEL (general toxicity) 25 ppm for males and 5 ppm for females (based on the effects noted in the thymus) equivalent to 1.8 mg/kg/day for male animals and 0.4 mg/kg /day in female animals. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a826807b-0546-4f57-a30d-fb3736c2c08e/documents/IUC5-68d3d1c7-5f45-482d-863a-a6ed0bc4a409_49c33b65-d83c-441f-b188-5412fa1c7787.html,,,,,, Dioctyltin oxide,870-08-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a826807b-0546-4f57-a30d-fb3736c2c08e/documents/IUC5-68d3d1c7-5f45-482d-863a-a6ed0bc4a409_49c33b65-d83c-441f-b188-5412fa1c7787.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.4 mg/kg bw/day,,rat Dioctyltin oxide,870-08-6,"ORALKey study: Bathe (1972), Similar to OECD 401, LD50 > 6000 mg/kg bw (male and female rats)   DERMALKey study: Sanders (2012), OECD 402, EU Method B.3, LD50 > 2000 mg/kg bw (male and female rats)   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a826807b-0546-4f57-a30d-fb3736c2c08e/documents/IUC5-8b849db6-f490-44ac-8aee-40b598e6de29_49c33b65-d83c-441f-b188-5412fa1c7787.html,,,,,, Dioctyltin oxide,870-08-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a826807b-0546-4f57-a30d-fb3736c2c08e/documents/IUC5-8b849db6-f490-44ac-8aee-40b598e6de29_49c33b65-d83c-441f-b188-5412fa1c7787.html,,oral,LD50,"> 6,000 mg/kg bw",no adverse effect observed, Dioctyltin oxide,870-08-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a826807b-0546-4f57-a30d-fb3736c2c08e/documents/IUC5-8b849db6-f490-44ac-8aee-40b598e6de29_49c33b65-d83c-441f-b188-5412fa1c7787.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Dioleamide,72901-31-6," Oral administration of oleyl palmitamide , the source substance to male and female Wistar rats for 90 days at dose levels corresponding to 100, 500 or 1000 mg/kg/day 7d/week (dietary concentrations of 1000, 6000, 12000 ppm) led to no adverse effect on any of the parameters examined. Thus a dietary concentration of 12000 ppm (corresponding to a nominal dose of 1000 mg/kg bw/day) was determined as NOEL. Significant intergroup differences in individual parameters were generally within normal limits and without any dose-relationship. These differences were therefore considered to be without biological importance and not attributable to test substance exposure. For the reasons specified in our read across rational (see chapter 13 of IUCLID and the annexes of the CSR) this study is considered relevant for the target substance and it is concluded that the target substance will not cause any adverse effects upon repeated exposure to a limit dose of 1000 mg/kg bw whichis considered a relvant maximum dose in a guideline repeated dose study. This is consistent with the fact that the substance is likely to be metabolised via physiological pathways in the fatty acid metabolism. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/749de59d-6963-4720-880d-f68a86747cde/documents/40454325-d885-4327-aba8-cfc8938430f8_0ec70752-69f1-49fd-800a-f02e39330539.html,,,,,, Dioleamide,72901-31-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/749de59d-6963-4720-880d-f68a86747cde/documents/40454325-d885-4327-aba8-cfc8938430f8_0ec70752-69f1-49fd-800a-f02e39330539.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dioleamide,72901-31-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The read-across (CAS 16260-09-6) rat acute oral LD50 is >2400 mg/kg. This is a GLP, guideline study performed in 1986. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The vapor pressure of CAS 72901-31-6 is 2.6E-16 mmHg@25 degrees C. For chemicals with a vapor pressure < 10E-6 there is low concern for inhalation exposure. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The read-across (CAS 16260-09-6) dermal LD50 is >2000 mg/kg. This is a GLP, guideline study. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/749de59d-6963-4720-880d-f68a86747cde/documents/19cf3311-4ec8-4174-a203-46a69e4226ad_0ec70752-69f1-49fd-800a-f02e39330539.html,,,,,, Dioleamide,72901-31-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/749de59d-6963-4720-880d-f68a86747cde/documents/19cf3311-4ec8-4174-a203-46a69e4226ad_0ec70752-69f1-49fd-800a-f02e39330539.html,,oral,LD50,"2,400 mg/kg bw",no adverse effect observed, Dioleamide,72901-31-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/749de59d-6963-4720-880d-f68a86747cde/documents/19cf3311-4ec8-4174-a203-46a69e4226ad_0ec70752-69f1-49fd-800a-f02e39330539.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dioxobis(stearato)trilead,12578-12-0," Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/71776e1a-0027-4591-892c-a845aadf3499/documents/55240df1-e7fa-4fe8-8269-766f9e1416fc_26f0b4f5-d9d0-4e91-bfa7-1c126f56e767.html,,,,,, Dioxobis(stearato)trilead,12578-12-0, Inorganic lead compounds do not exhibit toxicity in acute toxicity tests with experimental animals. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71776e1a-0027-4591-892c-a845aadf3499/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_26f0b4f5-d9d0-4e91-bfa7-1c126f56e767.html,,,,,, Dioxobis(stearato)trilead,12578-12-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71776e1a-0027-4591-892c-a845aadf3499/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_26f0b4f5-d9d0-4e91-bfa7-1c126f56e767.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dioxobis(stearato)trilead,12578-12-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71776e1a-0027-4591-892c-a845aadf3499/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_26f0b4f5-d9d0-4e91-bfa7-1c126f56e767.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dioxobis(stearato)trilead,12578-12-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71776e1a-0027-4591-892c-a845aadf3499/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_26f0b4f5-d9d0-4e91-bfa7-1c126f56e767.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "3,5,5-Trimethylhexanoic acid, mixed esters with dipentaerythritol and heptanoic acid",1379424-11-9," There is no data available on repeated dose toxicity of Dipentaerythritol hexaesters of 3,5,5-trimethylhexanoic and n-heptanoic acids (CAS 1379424 -11 -9). In order to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from a structurally related substance was conducted. The substance EC 444 -000-2 consists of dipentaerythritol hexaesters with fatty acids n-pentanoic and 3,5,5 -trimethylhexanoic acid and it is considered to be similar to the target substance, on the basis of the structural and similar properties and/or activties. The available data on repeated dose toxicity for the source substance (OECD 407, Oral NOAEL (rat, m/f): 1000 mg/kg bw/day) is used to preduct the same behaviour for the target substance Dipentaerythritol hexaesters of 3,5,5 -trimethylhexanoic and n-heptanoic acids (CAS 1379424 -11 -9). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6af5f0d6-3bcd-41c6-8bcb-50e264a44c78/documents/9bc42628-0faa-44b0-ae53-61235fbdfc4a_768a87fe-263a-42e9-98f4-66dbd073e348.html,,,,,, "3,5,5-Trimethylhexanoic acid, mixed esters with dipentaerythritol and heptanoic acid",1379424-11-9," There is no data available for the acute toxicity of Dipentaerythritol hexaesters of 3,5,5-trimethylhexanoic and n-heptanoic acids (CAS 1379424 -11 -9). In order to fulfill the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from a structurally related substance was conducted. The substance Dipentaerythritol hexaesters of nC5/iC9 consists of dipentaerythritol hexaesters with fatty acids C5 and C9 iso and it is considered to be similar to the target substance, on the basis of the structural and similar properties and/or activties. The available acute toxicity study (oral route) for the source substance (GLP study, OECD 423 method, result LD50 > 2000 mg/kg bw) is used to predict the same behaviour for the target substance Dipentaerythritol hexaesters of 3,5,5 -trimethylhexanoic and n-heptanoic acids (CAS 1379424 -11 -9). The available acute toxicity study (dermal route) for the source substance (GLP study, Annex V Directive 67/548/EEC guideline, result LD50 > 2000 mg/kg bw) is used to predict the same behaviour for the target substance Dipentaerythritol hexaesters of 3,5,5 -trimethylhexanoic and n-heptanoic acids (CAS 1379424 -11 -9). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6af5f0d6-3bcd-41c6-8bcb-50e264a44c78/documents/a88b9d0d-e88b-4dff-be66-c9f9186fe448_768a87fe-263a-42e9-98f4-66dbd073e348.html,,,,,, "3,5,5-Trimethylhexanoic acid, mixed esters with dipentaerythritol and heptanoic acid",1379424-11-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6af5f0d6-3bcd-41c6-8bcb-50e264a44c78/documents/a88b9d0d-e88b-4dff-be66-c9f9186fe448_768a87fe-263a-42e9-98f4-66dbd073e348.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,5,5-Trimethylhexanoic acid, mixed esters with dipentaerythritol and heptanoic acid",1379424-11-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6af5f0d6-3bcd-41c6-8bcb-50e264a44c78/documents/a88b9d0d-e88b-4dff-be66-c9f9186fe448_768a87fe-263a-42e9-98f4-66dbd073e348.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dipentylammonium dipentyldithiocarbamate,71902-20-0, The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be in the range of 300 - 2000 mg/kg body weight (Globally Harmonized Classification System-Category 4). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/915fef2c-1a06-4df5-8d28-1483f678336f/documents/37711f1a-c291-42ba-b364-bf8ddb9dbfde_313e81f3-eb53-473a-a50a-290831e01272.html,,,,,, Diphenyl azidophosphate,26386-88-9," No data were found for DPPA in the scientific literature. The classification for acute toxicity is based on expert judgement and in particular considering the chemical category “Organophosphorus compounds” of the substance. Organophosphorus compounds (OPs) can exert significant adverse effects in non-target species including humans. Because of the phosphorylation of acetylcholinesterase, they exert primarily a cholinergic toxicity, however, some can also cause a delayed polyneuropathy. Their relative toxicities are based on World Health Organization Guidelines and The Globally Harmonized Hazard System of Classification and Labeling of Chemicals (GHS). The extremely toxic OPs are designed to Category 1, which are rated by their toxicity orally in the rat based on technical compound and generally show an LD50 of less than 5 mg/kg. The highly toxic OPs showing LD50 values of 5-50 mg/Kg are designed to Category 2. Their dermal and inhalation toxicity is also confirmed by GHS System. The classification are been established according to information reported in the SDS of the supplier. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9af768a-2cd8-4323-b893-a98d20d469d1/documents/463d4fcf-c3d9-4556-8d30-59a01a659410_49172dca-9d4a-4401-8fc7-85a264bead30.html,,,,,, Diphenyl carbonate,102-09-0,"ORAL - The NOAEL in males was 1500 ppm (about 132 mg/kg bw/day), the LOAEL in females was 1500 ppm (about 219 mg/kg bw/day), OECD 415/416, Eiben (2003a). - The NOAEL in females was 50 mg/kg/day, no guideline followed, Eiben (2003b). There are four studies to address this endpoint, two key studies and two supporting studies. One of the key studies was awarded a reliability score of 1 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997). The remaining key study and the supporting studies were all awarded a reliability score of 2. The quality of the database is therefore considered to be high. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a880fcf7-dc1f-4600-ac76-ff9184791573/documents/IUC5-45b9acb8-433f-4791-a522-03385f48abff_833eadfb-0003-46fa-a728-a0d7876db98c.html,,,,,, Diphenyl carbonate,102-09-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a880fcf7-dc1f-4600-ac76-ff9184791573/documents/IUC5-45b9acb8-433f-4791-a522-03385f48abff_833eadfb-0003-46fa-a728-a0d7876db98c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Diphenyl carbonate,102-09-0,"ORAL LD50 1500 mg/kg bw , rat (male/female), OECD 401, FitzGerald (1990) The quality of the whole database is considered to be good. The key study was performed in accordance with a standardised guideline under GLP conditions. There are a further six supporting studies available, all with limited documentation, and thus all awarded a reliability score of 2 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997).   DERMAL LD50 >2000 mg/kg bw, rat (male/female), OECD 402, Krötlinger (1999) The quality of the whole database is considered to be good. The key study and one supporting study were performed in accordance with a standardised guideline under GLP conditions. There is a further supporting study available, with limited documentation, awarded a reliability score of 2 in accordance with the criteria for assessing data quality as set forth by Klimisch et al. (1997). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a880fcf7-dc1f-4600-ac76-ff9184791573/documents/IUC5-7cf90ecf-2433-403f-8bd0-d7de7d62745e_833eadfb-0003-46fa-a728-a0d7876db98c.html,,,,,, Diphenyl carbonate,102-09-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a880fcf7-dc1f-4600-ac76-ff9184791573/documents/IUC5-7cf90ecf-2433-403f-8bd0-d7de7d62745e_833eadfb-0003-46fa-a728-a0d7876db98c.html,,oral,LD50,"1,500 mg/kg bw",adverse effect observed, Diphenyl carbonate,102-09-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a880fcf7-dc1f-4600-ac76-ff9184791573/documents/IUC5-7cf90ecf-2433-403f-8bd0-d7de7d62745e_833eadfb-0003-46fa-a728-a0d7876db98c.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Diphenyl methylphosphonate,7526-26-3,"Predicted NOAEL of 318 mg/kg bw.   A 28 Day Oral Gavage Toxicity Study in the Rat (without recovery; according to OECD 407 / OPPTS 870.3050 / EC B.7 / GLP) has been ordered in a CRO to improve the dataset for this endpoint and have a more robust point-of-departure for the DNEL derivation.  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 4 of 5 category members are phosphates while DPP is a phosphonate. An additional assessment factor of 5 is proposed to cover uncertainties due to the read-across. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/81e972b2-3776-4680-aa1e-488420d17955/documents/IUC5-1dd77f94-26f2-490b-adfa-7f1601ba87f5_375c162c-93f5-440a-ad59-8633ce253ce7.html,,,,,, Diphenyl methylphosphonate,7526-26-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/81e972b2-3776-4680-aa1e-488420d17955/documents/IUC5-1dd77f94-26f2-490b-adfa-7f1601ba87f5_375c162c-93f5-440a-ad59-8633ce253ce7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,318 mg/kg bw/day,,rat Diphenyl methylphosphonate,7526-26-3,DPP was found to be toxic via oral and dermal routes of exposure (oral LD50 of 233 mg/kg bw in male Wistar rats; dermal LD50 of 786 mg/kg bw and 569 mg/kg bw for male and female Wistar rats) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81e972b2-3776-4680-aa1e-488420d17955/documents/IUC5-7fc57e96-c9a6-40a5-a0f8-a8ae475c9a6b_375c162c-93f5-440a-ad59-8633ce253ce7.html,,,,,, Diphenyl methylphosphonate,7526-26-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81e972b2-3776-4680-aa1e-488420d17955/documents/IUC5-7fc57e96-c9a6-40a5-a0f8-a8ae475c9a6b_375c162c-93f5-440a-ad59-8633ce253ce7.html,,oral,LD50,233 mg/kg bw,adverse effect observed, Diphenyl methylphosphonate,7526-26-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81e972b2-3776-4680-aa1e-488420d17955/documents/IUC5-7fc57e96-c9a6-40a5-a0f8-a8ae475c9a6b_375c162c-93f5-440a-ad59-8633ce253ce7.html,,dermal,LD50,569 mg/kg bw,adverse effect observed, Diphenyl phosphonate,4712-55-4,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyInformation.KeyInformation): Diphenyl phosphonate (DPP) is expected to have similar toxicology to that of triphenyl phosphite (TPP), which is a structurally similar compound and minor constituent in DPP. This relationship is explained more fully in the paper attached in Section 13 of this dossier. TPP produced systemic toxicity at an oral dose of 40 mg/kg/day in a well conducted OECD 422 study which was extended and studied effects in F1 offspring treated to postpartum Day 70. The NOAEL in both the parental animals and the F1 offspring was 15 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4febe84b-cce8-4162-9509-af9b13eb2d10/documents/f1582f00-8cd5-464e-9127-ac454384d671_9d25a0be-5ca9-4207-941d-910c039bbc6c.html,,,,,, Diphenyl phosphonate,4712-55-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4febe84b-cce8-4162-9509-af9b13eb2d10/documents/f1582f00-8cd5-464e-9127-ac454384d671_9d25a0be-5ca9-4207-941d-910c039bbc6c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat Diphenyl phosphonate,4712-55-4,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyInformation.KeyInformation): Diphenyl phosphonate (DPP) is expected to be similar in acute toxicity to that of triphenyl phosphite (TPP), which is a structural similar compound and minor constituent in DPP. This relationship is explained more fully in the paper attached in Section 13 of this dossier. TPP has an oral LD50 is in the range for classification at Acute Tox 4. This same acute toxicity classification has been applied to DPP. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4febe84b-cce8-4162-9509-af9b13eb2d10/documents/273e302d-e550-4340-8377-71d810f07ab3_9d25a0be-5ca9-4207-941d-910c039bbc6c.html,,,,,, Diphenyl phosphonate,4712-55-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4febe84b-cce8-4162-9509-af9b13eb2d10/documents/273e302d-e550-4340-8377-71d810f07ab3_9d25a0be-5ca9-4207-941d-910c039bbc6c.html,,oral,LD50,"1,590 mg/kg bw",, Diphenyl phosphonate,4712-55-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4febe84b-cce8-4162-9509-af9b13eb2d10/documents/273e302d-e550-4340-8377-71d810f07ab3_9d25a0be-5ca9-4207-941d-910c039bbc6c.html,,dermal,LD50,"2,000 mg/kg bw",, Diphenyl phosphonate,4712-55-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4febe84b-cce8-4162-9509-af9b13eb2d10/documents/273e302d-e550-4340-8377-71d810f07ab3_9d25a0be-5ca9-4207-941d-910c039bbc6c.html,,inhalation,LC50,"6,700 mg/m3",, Diphenyl phosphorochloridate,2524-64-3,"LD50 >300 to < 2000 mg/kg bw (Wistar rat, male/female), OECD 423, Cerven (2008) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69f38014-2ea3-440f-95c4-4d4c01602a28/documents/IUC5-4ba40cd2-8db4-4dda-a792-8fb249a4f2ca_26e88deb-e50c-4f17-ba5e-1858b40a369f.html,,,,,, Diphenyl phosphorochloridate,2524-64-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69f38014-2ea3-440f-95c4-4d4c01602a28/documents/IUC5-4ba40cd2-8db4-4dda-a792-8fb249a4f2ca_26e88deb-e50c-4f17-ba5e-1858b40a369f.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Diphenyl sulphone,127-63-9,"Sprague Dawley rats of received diets containing 100, 200 or 2000 ppm diphenyl sulphone for a period of 13 weeks, corresponding to mean test article intake values of 8, 16 and 164 mg/kg bw/day in males and 9, 19 and 206 mg/kg bw/day in females, respectively. NOEL was 100 ppm (8-9 mg/kg bw/day) and NOAEL was considered to be 200 ppm (16-19 mg/kg bw/day). Adaptive changes were seen at 200 ppm, as demonstrated by increased liver weights and cellular hypertrophy, whereas toxicological changes were seen at 2000 ppm (corresponding with 164 and 206 mg/kg bw/day) as demonstrated by changes in body weight gain, food intake, blood and urine chemistry, liver and kidney weights, histopathology, peroxisome proliferation and electron microscopy of liver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57e0e400-4dfb-4449-9e55-b89d19acb762/documents/IUC5-350573c6-17ea-4042-a4c4-b3abdff23a07_f7cb8c60-ddd5-418c-84ae-9e11ddf47729.html,,,,,, Diphenyl sulphone,127-63-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57e0e400-4dfb-4449-9e55-b89d19acb762/documents/IUC5-350573c6-17ea-4042-a4c4-b3abdff23a07_f7cb8c60-ddd5-418c-84ae-9e11ddf47729.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16 mg/kg bw/day,,rat Diphenyl sulphone,127-63-9,The acute oral LD50 of the test material in the Sprague-Dawley CD (Crl: CD® (SD) IGS BR) strain rat was estimated to be in the range of 300 - 500 mg/kg bodyweight. The dermal LD50 value of diphenyl sulphone in Wistar rats was established to exceed 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57e0e400-4dfb-4449-9e55-b89d19acb762/documents/IUC5-0744126e-5d4b-4125-a540-a1f62d4ee6e2_f7cb8c60-ddd5-418c-84ae-9e11ddf47729.html,,,,,, Diphenyl sulphone,127-63-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57e0e400-4dfb-4449-9e55-b89d19acb762/documents/IUC5-0744126e-5d4b-4125-a540-a1f62d4ee6e2_f7cb8c60-ddd5-418c-84ae-9e11ddf47729.html,,oral,LD50,400 mg/kg bw,adverse effect observed, Diphenyl sulphone,127-63-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57e0e400-4dfb-4449-9e55-b89d19acb762/documents/IUC5-0744126e-5d4b-4125-a540-a1f62d4ee6e2_f7cb8c60-ddd5-418c-84ae-9e11ddf47729.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Diphenyl[4-(phenylsulfanyl)phenyl] sulfonium hexafluoroantimonate(1-),71449-78-0, Acute Oral Toxicity: LD50 = > 300 mg/kg bw/d - OECD 420 - 2008 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0947ab3-4a89-4aab-86f9-b2abc2ef5d95/documents/9312fd7d-1268-49dd-9ba1-4708e84166ee_f49f867b-0b85-4d3c-868a-08a59383dd02.html,,,,,, Diphenyl[4-(phenylsulfanyl)phenyl] sulfonium hexafluoroantimonate(1-),71449-78-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0947ab3-4a89-4aab-86f9-b2abc2ef5d95/documents/9312fd7d-1268-49dd-9ba1-4708e84166ee_f49f867b-0b85-4d3c-868a-08a59383dd02.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Diphenylsilanediol,947-42-2,"No effects were noted in the key oral and dermal acute toxicity studies and the LD50 in both was greater than 2000 mg/kg, the highest dose tested. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cc2d07f-fda0-439d-a8b9-f0426546b824/documents/IUC5-b5a34c91-ea2d-43af-9289-d819f11b1198_49742093-dbf2-4a03-8ec0-9ad438221787.html,,,,,, Diphenylsilanediol,947-42-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cc2d07f-fda0-439d-a8b9-f0426546b824/documents/IUC5-b5a34c91-ea2d-43af-9289-d819f11b1198_49742093-dbf2-4a03-8ec0-9ad438221787.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Diphenylsilanediol,947-42-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cc2d07f-fda0-439d-a8b9-f0426546b824/documents/IUC5-b5a34c91-ea2d-43af-9289-d819f11b1198_49742093-dbf2-4a03-8ec0-9ad438221787.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Diphosphoric acid, compd. with piperazine",66034-17-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26de1f9d-87c9-4812-97f7-01f67629bc22/documents/IUC5-90127d8b-b5db-492c-8f2e-bca1e5210912_a32b50fc-7adb-4d8e-8fa6-ba82943c5190.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine",15541-60-3," For the oral route, a gavage 28-day repeat dose toxicity study (OECD 407, GLP) was performed with MPP.  Based on histopathological changes in the kidney (tubular basophilia/dilation) the No Observed Adverse Effect Level (NOAEL) in the 28-day repeat dose toxicity study was established as 15 mg/kg bw/day.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef994b6f-f087-49a8-8ace-281b54da10db/documents/IUC5-7501fba9-bd33-4da0-9dd5-0b35f1630151_ef235717-81ec-49e8-86bc-283b756c889a.html,,,,,, "Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine",15541-60-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef994b6f-f087-49a8-8ace-281b54da10db/documents/IUC5-7501fba9-bd33-4da0-9dd5-0b35f1630151_ef235717-81ec-49e8-86bc-283b756c889a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine",15541-60-3,MPP has low acute oral (LD50>2000 mg/kg bw) and dermal toxicity (LD50>2000 mg/kg bw) in rats. There are no data available on the acute inhalational toxicity of the notified polymer. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef994b6f-f087-49a8-8ace-281b54da10db/documents/IUC5-4bf8d028-e4c2-4d84-af00-c8ec6031cb15_ef235717-81ec-49e8-86bc-283b756c889a.html,,,,,, "Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine (1:2)",13518-93-9," No studies are available with diphosphoric acid, compound with 1,3,5 -triazine-2,4,6 -triamine (1:2). However, reliable data are available for the structrual analogue substance 1,3,5 -triazine-2,4,6 -triamine (melamine, CAS 108 -78 -1). The assessment of repeated dose toxicity is based on repeated dose toxicity studies in rats and mice (similar to OECD 408 and 452) performed with melamine (NTP 1983). NOAEL rat (13 weeks) = 72 and 84 mg/kg bw/day for males and females, respectively NOAEL rat (103 weeks) = 126 mg/kg bw/day for males LOAEL rat (103 weeks) = 262 mg/kg bw/day for females ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c0fdf94-1760-469d-8eb8-1e1a860d8046/documents/d6ee72b5-466b-4c30-921e-7853d11ddde6_2aee2895-f8f2-44b0-8817-34adfc9ac361.html,,,,,, "Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine (1:2)",13518-93-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c0fdf94-1760-469d-8eb8-1e1a860d8046/documents/d6ee72b5-466b-4c30-921e-7853d11ddde6_2aee2895-f8f2-44b0-8817-34adfc9ac361.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,72 mg/kg bw/day,,rat "Diphosphoric acid, compound with 1,3,5-triazine-2,4,6-triamine (1:2)",13518-93-9," Oral (OECD 423), rat: LD50 cut-off = 5000 mg/kg bw Inhalation (OCED 436), rat, 4 h exposure: LC50 cut-off = 3.81 mg/L Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c0fdf94-1760-469d-8eb8-1e1a860d8046/documents/beb7afcb-7031-4170-bbcb-427c7c4d888d_2aee2895-f8f2-44b0-8817-34adfc9ac361.html,,,,,, "Diphosphoric acid, copper salt",10102-90-6," The pivotal repeated dose study was a 90-day study by the oral route with copper sulphate pentahydrate. In rats and mice, ingestion of copper sulphate pentahydrate produced forestomach lesions that could be to the irritant effects of the compound. The NOAEL for this effect was 16.7 mg Cu/kg bw/day in rats and 97 and 126 mg Cu/kg bw/day in male and female mice respectively. In rats inflammation of the liver was observed. The NOAEL’s for liver and kidney damage were 16.7 mg Cu/kg bw/day in rats. This is the pivotal study and the NOAEL of 16.7 mg Cu/kg bw/day will be used in the risk characterisation. The inhalation study LOEC is 0.2 mg cuprous oxide/m3, as (non-adverse) effects were seen at this dose. The study NOAEC is >= 2 mg/kg cuprous oxide/m3, the highest dose level tested and based on the lack of findings in the lung weight ratio. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f78ffb6d-d4e3-4bc7-8d5f-fe406312a252/documents/c16501a2-b2c0-4765-a6c4-0446981e3750_73d22a9e-3c32-4504-8d3e-908efb04e89a.html,,,,,, "Diphosphoric acid, copper salt",10102-90-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f78ffb6d-d4e3-4bc7-8d5f-fe406312a252/documents/c16501a2-b2c0-4765-a6c4-0446981e3750_73d22a9e-3c32-4504-8d3e-908efb04e89a.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,2 mg/m3,,rat "Diphosphoric acid, copper salt",10102-90-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f78ffb6d-d4e3-4bc7-8d5f-fe406312a252/documents/c16501a2-b2c0-4765-a6c4-0446981e3750_73d22a9e-3c32-4504-8d3e-908efb04e89a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat "Diphosphoric acid, copper salt",10102-90-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f78ffb6d-d4e3-4bc7-8d5f-fe406312a252/documents/c16501a2-b2c0-4765-a6c4-0446981e3750_73d22a9e-3c32-4504-8d3e-908efb04e89a.html,Repeated dose toxicity – local effects,inhalation,NOAEC,2 mg/m3,no adverse effect observed,rat "Diphosphoric acid, copper salt",10102-90-6,"Oral: LD50(rat, f) > 2000 mg/kg bw (OECD 423, GLP)Inhalation: LC50(4 h, rat, m/f) >1-5 mg/L (OECD 436, GLP)Dermal: No study available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f78ffb6d-d4e3-4bc7-8d5f-fe406312a252/documents/IUC5-83142762-224d-46e5-836b-5352b3f59c1a_73d22a9e-3c32-4504-8d3e-908efb04e89a.html,,,,,, "Diphosphoric acid, copper salt",10102-90-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f78ffb6d-d4e3-4bc7-8d5f-fe406312a252/documents/IUC5-83142762-224d-46e5-836b-5352b3f59c1a_73d22a9e-3c32-4504-8d3e-908efb04e89a.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Tetrabenzyl pyrophosphate,990-91-0,"LD50 > 5000 mg/kg bw in an acute oral toxicity study on mice (no guideline followed, non-GLP, rel.4, K) LD50 > 2000 mg/kg bw in a limit test by dermal route on rats (OECD 402, GPL, rel.2, K) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e9b3e6a-3132-4909-beab-bf4f49e28885/documents/b2d02923-5935-4eec-a94a-bb54b571c3e0_fac9249b-bdc0-44c4-818e-5fce04fd8611.html,,,,,, Tetrabenzyl pyrophosphate,990-91-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e9b3e6a-3132-4909-beab-bf4f49e28885/documents/b2d02923-5935-4eec-a94a-bb54b571c3e0_fac9249b-bdc0-44c4-818e-5fce04fd8611.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Tetrabenzyl pyrophosphate,990-91-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e9b3e6a-3132-4909-beab-bf4f49e28885/documents/b2d02923-5935-4eec-a94a-bb54b571c3e0_fac9249b-bdc0-44c4-818e-5fce04fd8611.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Diphosphoric acid, zinc salt, compd. with 1,3 ,5 triazine, 2,4,6 triamine (1 :1 :2)",1271172-98-5,A 28-day repeated dose study conducted in rat via oral exposure in accordance with OECD guideline 407 is available.  No adverse toxicological effects were observed in the study and the NOAEL was set at 1000 mg/kg bw (the highest dose group tested). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5f2c66c-e5fb-4192-8cf2-3bc4e40f9092/documents/67b0c2ac-dfa7-47a4-996e-bc9ce837c278_fa11585c-890e-4060-8c04-8729ad745860.html,,,,,, "Diphosphoric acid, zinc salt, compd. with 1,3 ,5 triazine, 2,4,6 triamine (1 :1 :2)",1271172-98-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5f2c66c-e5fb-4192-8cf2-3bc4e40f9092/documents/67b0c2ac-dfa7-47a4-996e-bc9ce837c278_fa11585c-890e-4060-8c04-8729ad745860.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Diphosphoric acid, zinc salt, compd. with 1,3 ,5 triazine, 2,4,6 triamine (1 :1 :2)",1271172-98-5,Studies conducted in accordance with OECD guidlelines are available for acute oral and inhalation toxicity.  The LD50 value in the oral study was >2000 mg/kg and the LC50 value in the inhalation study was >5 mg/L.  No local or systemic effects were observed during each study.    ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5f2c66c-e5fb-4192-8cf2-3bc4e40f9092/documents/0aa4ebfc-6031-48f3-8645-556b61891abb_fa11585c-890e-4060-8c04-8729ad745860.html,,,,,, "Diphosphoric acid, zinc salt, compd. with 1,3 ,5 triazine, 2,4,6 triamine (1 :1 :2)",1271172-98-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5f2c66c-e5fb-4192-8cf2-3bc4e40f9092/documents/0aa4ebfc-6031-48f3-8645-556b61891abb_fa11585c-890e-4060-8c04-8729ad745860.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Diphosphoric acid, zinc salt, compd. with 1,3 ,5 triazine, 2,4,6 triamine (1 :1 :2)",1271172-98-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5f2c66c-e5fb-4192-8cf2-3bc4e40f9092/documents/0aa4ebfc-6031-48f3-8645-556b61891abb_fa11585c-890e-4060-8c04-8729ad745860.html,,inhalation,LC50,> 5 mg/L,no adverse effect observed, Diphosphorus pentasulphide,1314-80-3," Acute toxicity: oral (similar OECD 401): LD50 (rat, m) = 791 mg/kg bw Acute toxicity: dermal (similar OECD 402): LD50 (rabbit, m/f) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6e710d6-3293-497c-a4ae-30923a85aa9f/documents/d5f31165-86bf-40c5-92dd-96324cf0c923_ae66baf1-c4b0-4018-9819-3607676f91a0.html,,,,,, Diphosphorus pentasulphide,1314-80-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6e710d6-3293-497c-a4ae-30923a85aa9f/documents/d5f31165-86bf-40c5-92dd-96324cf0c923_ae66baf1-c4b0-4018-9819-3607676f91a0.html,,oral,LD50,791 mg/kg bw,adverse effect observed, "Dipotassium [[N,N'-ethylenebis[N-(carboxylatomethyl)glycinato]](4-)-N,N',O,O',ON,ON']zincate(2-)",14689-29-3," With regard to the evaluation of repeated dose toxicity for EDTA-ZnK2, results of the study with EDTA-CaNa2 were compared with studies with other metal chelates and with EDTA (see below). One repeated inhalation toxicity study was avalaible for DTPA-CaNa3, another, Ca-containing chelate.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd1084f1-c363-4c6a-b845-2a1bcd09345c/documents/IUC5-5a9a048a-67be-4781-9eba-55bc9500d9b4_68cea145-9ea3-49cb-8641-036f9e62d861.html,,,,,, "Dipotassium [[N,N'-ethylenebis[N-(carboxylatomethyl)glycinato]](4-)-N,N',O,O',ON,ON']zincate(2-)",14689-29-3," The acute oral LD50 value in rats was > 2000 mg/kg bw. Although an acute inhalation with this substance was not performed, inhalation studies with other metal chelates showed that these substances are not toxic (4-h LC50 value > 5 mg/L). In addition, acute dermal toxicity studies with other metal chelates showed that LD50 values were in excess of 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd1084f1-c363-4c6a-b845-2a1bcd09345c/documents/IUC5-6088febc-4c09-4b08-a3ca-ab54981d46e3_68cea145-9ea3-49cb-8641-036f9e62d861.html,,,,,, "Dipotassium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cobaltate(2-)",14025-10-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbd11e2c-f1ff-4790-b72a-6463a8e985a7/documents/20283490-8e2b-4577-abf5-fecc5bf28418_c52c9fbd-2fcf-4def-adcd-389dea73f469.html,,oral,LD50,789 mg/kg bw,adverse effect observed, "Dipotassium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)",74181-84-3,One well performed and reported subchronic oral toxicity study was available for EDTA-CuNa2. See the read across document in section 13 for studies with other (metal) chelates. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a0ffd40-4709-4ecb-871f-607f427de5db/documents/IUC5-5b706424-b8f9-433f-adab-ffc5ca7fdf25_906f4444-8f1b-4ccc-8c58-5395125d88bb.html,,,,,, "Dipotassium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)",74181-84-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a0ffd40-4709-4ecb-871f-607f427de5db/documents/IUC5-5b706424-b8f9-433f-adab-ffc5ca7fdf25_906f4444-8f1b-4ccc-8c58-5395125d88bb.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,150 mg/kg bw/day,,rat "Dipotassium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)",74181-84-3,"The oral LD50 value in rats was between 300 and 2000 mg/kg bw; the 4-h LC50 value of the structurally related substance EDTA-CuNa2 is in excess of 5.30 g/m3. No acute dermal toxicity studies are available but based on read across (see also section 13), acute dermal toxicity following exposure to EDTA-CuK2 is not expected.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a0ffd40-4709-4ecb-871f-607f427de5db/documents/IUC5-ea6f1de9-9090-4515-88d4-eaad2ef8d294_906f4444-8f1b-4ccc-8c58-5395125d88bb.html,,,,,, "Dipotassium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']cuprate(2-)",74181-84-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a0ffd40-4709-4ecb-871f-607f427de5db/documents/IUC5-ea6f1de9-9090-4515-88d4-eaad2ef8d294_906f4444-8f1b-4ccc-8c58-5395125d88bb.html,,oral,discriminating dose,500 mg/kg bw,adverse effect observed, "Dipotassium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']manganate(2-)",68015-77-0,"An oral study with EDTA-MnNa2 in which males were treated for at least 12 weeks and females for almost 14 weeks showed effects on water intake, urinary sodium concentration, increased kidney weight and slight histopathological renal changes. Four repeated oral toxicity studies were available for EDTA-CaNa2; results of these studies were compared with studies with other metal chelates and with EDTA (see below). One repeated inhalation toxicity study was avalaible for DTPA-CaNa3. Several ip and iv studies were also available showing various effects but mostly on kidneys. However, as workers and consumers are not exposed via these non-physiological routes these studies are not further taken into account. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/506c0209-bd20-4398-aa1a-20a3d07f3f3f/documents/IUC5-443d356c-2c5b-4c2d-9bd7-6dbebe621804_dab39bdf-fd53-4c65-b412-27e65529358a.html,,,,,, "Dipotassium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']manganate(2-)",68015-77-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/506c0209-bd20-4398-aa1a-20a3d07f3f3f/documents/IUC5-443d356c-2c5b-4c2d-9bd7-6dbebe621804_dab39bdf-fd53-4c65-b412-27e65529358a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Dipotassium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']manganate(2-)",68015-77-0,The LD50 value in rats was in excess of 2000 mg/kg bw. Other metal chelates did not show inhalation or dermal toxicity. Non-physiological routes of exposure (iv and ip) also showed low acute toxicity. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/506c0209-bd20-4398-aa1a-20a3d07f3f3f/documents/IUC5-a45f36be-159a-47da-9126-84491fc30890_dab39bdf-fd53-4c65-b412-27e65529358a.html,,,,,, "Dipotassium 4,4'-bis[6-anilino-4-[bis(2-hydroxyethyl)amino-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",71230-67-6," Acute oral toxicity: LD50 was estimated to be 6964 mg/kg bw when Tif:MAGf male and female rats were orally exposed with Dipotassium 4,4'-bis[6-anilino-4-[bis(2-hydroxyethyl)amino-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/939f2705-eb39-4c64-9e27-94ebeaeb7509/documents/070fa5b4-0d28-4728-9969-0e4da81efdb9_20847a04-02b9-40fd-ae11-f30500f69349.html,,,,,, "Dipotassium 4,4'-bis[6-anilino-4-[bis(2-hydroxyethyl)amino-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",71230-67-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/939f2705-eb39-4c64-9e27-94ebeaeb7509/documents/070fa5b4-0d28-4728-9969-0e4da81efdb9_20847a04-02b9-40fd-ae11-f30500f69349.html,,oral,LD50,"6,964 mg/kg bw",no adverse effect observed, Dipotassium adipate,19147-16-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): No GLP, short description of the results, low number of animals, few organs examined, unclear number of animals examined, only one dose for females, purity not specified. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80609fa0-b48d-4213-a951-9f5ace7d7ef3/documents/IUC5-fb9bc38b-f7c1-4c20-8ae0-3bc6a35c3d9a_8266ee8a-b34d-48d7-9451-03eed06362e3.html,,,,,, Dipotassium adipate,19147-16-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80609fa0-b48d-4213-a951-9f5ace7d7ef3/documents/IUC5-fb9bc38b-f7c1-4c20-8ae0-3bc6a35c3d9a_8266ee8a-b34d-48d7-9451-03eed06362e3.html,Chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat Dipotassium adipate,19147-16-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): No GLP but overall good documentation, comparable to OECD TG 401. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): No GLP, short documentation, comparable to OECD TG 403 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Number of animals low, purity not specified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80609fa0-b48d-4213-a951-9f5ace7d7ef3/documents/IUC5-a07ff6d0-0eb7-466d-b1cc-427d4dabc327_8266ee8a-b34d-48d7-9451-03eed06362e3.html,,,,,, Dipotassium adipate,19147-16-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80609fa0-b48d-4213-a951-9f5ace7d7ef3/documents/IUC5-a07ff6d0-0eb7-466d-b1cc-427d4dabc327_8266ee8a-b34d-48d7-9451-03eed06362e3.html,,oral,LD50,"5,560 mg/kg bw",no adverse effect observed, Dipotassium adipate,19147-16-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80609fa0-b48d-4213-a951-9f5ace7d7ef3/documents/IUC5-a07ff6d0-0eb7-466d-b1cc-427d4dabc327_8266ee8a-b34d-48d7-9451-03eed06362e3.html,,inhalation,LC50,"7,700 mg/m3",no adverse effect observed, "Dipotassium bis[μ-[tartrato(4-)-O1,O2:O3,O4]]diantimonate(2-) , stereoisomer",11071-15-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0af86ec-ac79-4a7e-9417-2f61f721b4e7/documents/c37e0043-8ec2-4dff-883e-e061bc6c162e_85f2e6e5-3f38-4c15-86da-08f235482cb9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Dipotassium disulphate,7790-62-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Scientifically valid study ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6039b5fe-8350-4937-97db-49d7cea922e4/documents/IUC5-cb8bacff-6377-4787-ae05-6d7f3938bda2_ad68036d-6e79-4503-8e6e-97f6f8e4d9ba.html,,,,,, Dipotassium disulphate,7790-62-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6039b5fe-8350-4937-97db-49d7cea922e4/documents/IUC5-cb8bacff-6377-4787-ae05-6d7f3938bda2_ad68036d-6e79-4503-8e6e-97f6f8e4d9ba.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,886 mg/kg bw/day,,rat Dipotassium disulphate,7790-62-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6039b5fe-8350-4937-97db-49d7cea922e4/documents/IUC5-cb8bacff-6377-4787-ae05-6d7f3938bda2_ad68036d-6e79-4503-8e6e-97f6f8e4d9ba.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.3 mg/m3,adverse effect observed,rat Dipotassium disulphate,7790-62-7,Oral (based on read across to H2SO4 with correction for molecular weight differences): similar to OECD 401; rat LD50: 5547 mg/kg. Reliability = 2Inhalation (based on read across to H2SO4 with correction for molecular weight differences): similar to OECD 403; rat 4-hr LC50: 972 mg/m3. Reliability =2 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6039b5fe-8350-4937-97db-49d7cea922e4/documents/IUC5-d5f6bae1-5c3b-4f72-80e9-d9ac0e7cebc2_ad68036d-6e79-4503-8e6e-97f6f8e4d9ba.html,,,,,, Dipotassium disulphate,7790-62-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6039b5fe-8350-4937-97db-49d7cea922e4/documents/IUC5-d5f6bae1-5c3b-4f72-80e9-d9ac0e7cebc2_ad68036d-6e79-4503-8e6e-97f6f8e4d9ba.html,,oral,LD50,"5,547 mg/kg bw",, Dipotassium disulphate,7790-62-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6039b5fe-8350-4937-97db-49d7cea922e4/documents/IUC5-d5f6bae1-5c3b-4f72-80e9-d9ac0e7cebc2_ad68036d-6e79-4503-8e6e-97f6f8e4d9ba.html,,inhalation,LC50,972 mg/m3,, Dipotassium heptafluorotantalate,16924-00-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c46e010d-23d7-4cc5-b439-2b58ec60717a/documents/IUC5-a167e1c3-9124-43ec-89c3-7efd2cb322c5_bc2bc485-da25-431b-b4d4-c4ad4d6b527b.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Dipotassium heptafluorotantalate,16924-00-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c46e010d-23d7-4cc5-b439-2b58ec60717a/documents/IUC5-a167e1c3-9124-43ec-89c3-7efd2cb322c5_bc2bc485-da25-431b-b4d4-c4ad4d6b527b.html,,inhalation,LC50,"2,100 mg/m3",adverse effect observed, Dipotassium hexachloropalladate,16919-73-6," In an OECD Test Guideline 407 study, to GLP, rats were administered diammonium hexachloropalladate by gavage for 28 days. The systemic NOAEL was the highest tested dose (100 mg/kg bw/day). Although there were some treatment-related effects at this dose (histological inflammation of the glandular stomach mucosa of both sexes and elevated mean white blood cell counts in males), these were considered to reflect a local irritant effect of the test substance rather than systemic toxicity (Matting, 2015). The critical oral NOAEL for diammonium hexachloropalladate (100 mg/kg bw/day) equates to an NOAEL of 30 mg/kg bw/day for palladium (based on MWt ratio). In an GLP OECD Test Guideline 421 reproductive/developmental toxicity screening study (Török-Bathó, 2015), high dose (100 mg/kg bw/day) parental animals displayed only local effects in the glandular stomach mucosa, similar to those seen in the 28-day toxicity study. No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04ea74a1-cb20-4949-a8bc-9079abb73eea/documents/IUC5-b104d29e-ce89-4ac4-be68-8de022e2895c_3e4e0856-6e14-47cc-9267-0efee827748d.html,,,,,, Dipotassium hexachloropalladate,16919-73-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04ea74a1-cb20-4949-a8bc-9079abb73eea/documents/IUC5-b104d29e-ce89-4ac4-be68-8de022e2895c_3e4e0856-6e14-47cc-9267-0efee827748d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Dipotassium hexachloropalladate,16919-73-6," In a GLP study, conducted according to OECD guidelines, the acute oral LD50 of dipotassium hexachloropalladate in the rat has been calculated as 1448 mg/kg bw (Zechel, 1990). No acute inhalation or dermal toxicity data were identified (for dipotassium or diammonium hexachloropalladate). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04ea74a1-cb20-4949-a8bc-9079abb73eea/documents/IUC5-329861fc-ebf3-4d9d-8442-64e89b046da4_3e4e0856-6e14-47cc-9267-0efee827748d.html,,,,,, Dipotassium hexachloropalladate,16919-73-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04ea74a1-cb20-4949-a8bc-9079abb73eea/documents/IUC5-329861fc-ebf3-4d9d-8442-64e89b046da4_3e4e0856-6e14-47cc-9267-0efee827748d.html,,oral,LD50,"1,448 mg/kg bw",adverse effect observed, Dipotassium hexachloroplatinate,16921-30-5," In an OECD Test Guideline 407 study, to GLP, rats were administered diammonium hexachloroplatinate by gavage for 28 days. The systemic toxicity NOAEL was 10 mg/kg bw/day on the basis of clinical signs of toxicity (including reduced body weight and growth) in the mid and high dose groups (30 and 100 mg/kg bw/day), resulting in morphological changes to the kidneys and stomach (Hansen, 2015a).   In support, in an OECD Test Guideline 421 reproductive/developmental toxicity screening study, rats (12/sex/group) were administered diammonium hexachloroplatinate by oral gavage at doses of 0, 10, 30 or 100 mg/kg bw/day for at least 35 days. The study NOAEL was established to be 30 mg/kg bw/day for systemic toxicity (Hansen, 2015b).   No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6555493b-a35e-4403-8fe0-79d5cc95fd57/documents/41d120aa-6ac0-4477-ab7e-790bcbe1339a_d56689ff-c0d6-4170-9397-77a10d13fda1.html,,,,,, Dipotassium hexachloroplatinate,16921-30-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6555493b-a35e-4403-8fe0-79d5cc95fd57/documents/41d120aa-6ac0-4477-ab7e-790bcbe1339a_d56689ff-c0d6-4170-9397-77a10d13fda1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Dipotassium hexachloroplatinate,16921-30-5," The acute oral LD50 of potassium hexachloroplatinate was determined to be 195 mg/kg bw in rats (Berthold, 1995a).   No relevant acute dermal or inhalation toxicity data were identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6555493b-a35e-4403-8fe0-79d5cc95fd57/documents/5999b5f9-3ac6-44a5-b443-4a7f89e61fe4_d56689ff-c0d6-4170-9397-77a10d13fda1.html,,,,,, Dipotassium hexachloroplatinate,16921-30-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6555493b-a35e-4403-8fe0-79d5cc95fd57/documents/5999b5f9-3ac6-44a5-b443-4a7f89e61fe4_d56689ff-c0d6-4170-9397-77a10d13fda1.html,,oral,LD50,195 mg/kg bw,adverse effect observed, "Ferrate(4-), hexakis(cyano-.kappa.C)-, cobalt(2+) potassium (1:1:2), (OC-6-11)-",12549-23-4,"Oral (gavage) combined repeated dose and reproduction/developmental screening study, subacute, daily dose levels of 30, 100 and 300 mg/kg bw/day, Rat (Wistar strain): NOAEL = 30 mg/kg bw/day (actual dose received) (male/female) - (GLP, OECD Guideline 422) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd388d48-28f9-4875-9bc3-f53bf10ce9f4/documents/IUC5-71dc4ba2-beb5-4378-8acf-2b93d84c80d4_109cd995-6c14-49ac-9891-06f73e4d9b7e.html,,,,,, "Ferrate(4-), hexakis(cyano-.kappa.C)-, cobalt(2+) potassium (1:1:2), (OC-6-11)-",12549-23-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd388d48-28f9-4875-9bc3-f53bf10ce9f4/documents/IUC5-71dc4ba2-beb5-4378-8acf-2b93d84c80d4_109cd995-6c14-49ac-9891-06f73e4d9b7e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "Ferrate(4-), hexakis(cyano-.kappa.C)-, cobalt(2+) potassium (1:1:2), (OC-6-11)-",12549-23-4,"Acute toxicity: Acute (single dose, fixed dose method) Oral (gavage) Toxicity study, Rat (Wistar strain) f - (GLP, OECD Guideline 420, EU Method B1 bis): LD50 >2000 mg/kg bw (actual dose received) (female).Acute (24-hour, fixed dose method) Dermal (semiocclusive) Toxicity Study (Limit Test), Rat (Wistar Strain) m/f - (GLP, OECD Guideline 402, EU Method B3): LD50 >2000 mg/kg bw (actual dose received) (male/female). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd388d48-28f9-4875-9bc3-f53bf10ce9f4/documents/IUC5-a5e2a0cf-12ac-4500-9aca-6f9efff58124_109cd995-6c14-49ac-9891-06f73e4d9b7e.html,,,,,, "Ferrate(4-), hexakis(cyano-.kappa.C)-, cobalt(2+) potassium (1:1:2), (OC-6-11)-",12549-23-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd388d48-28f9-4875-9bc3-f53bf10ce9f4/documents/IUC5-a5e2a0cf-12ac-4500-9aca-6f9efff58124_109cd995-6c14-49ac-9891-06f73e4d9b7e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Ferrate(4-), hexakis(cyano-.kappa.C)-, cobalt(2+) potassium (1:1:2), (OC-6-11)-",12549-23-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd388d48-28f9-4875-9bc3-f53bf10ce9f4/documents/IUC5-a5e2a0cf-12ac-4500-9aca-6f9efff58124_109cd995-6c14-49ac-9891-06f73e4d9b7e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dipotassium hexafluorotitanate,16919-27-0,"OECD 408, GLP, rat feeding: Under the conditions of this study and based on the toxicological endpoints evaluated, a no-observed-adverse-effect level (NOAEL) was not reached in males or females for DiPotassium hexafluorotitanate (IV) – 01727.  Microscopic findings that were considered adverse, consisting of degenerative nephropathy, ameloblast degeneration, and necrosis, dentin alteration, parathyroid gland hyperplasia, decreased bone, fibrous osteodystrophy, and reproductive organ atrophy were present in both sexes at the lowest dietary level, 250 ppm. Based on target nominal concentrations, intakes of 12.5, 25.6, and 45.9 mg/kg/day in male rats, and 17.0, 32.9, and 61.8 mg/kg/day in female rats were calculated for Groups 2-4, respectively.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ec1f392-1d6f-4105-b790-95bb1bf5d11a/documents/IUC5-fca1c314-3a4a-49ae-abb7-9dd04709eea2_2fdc653f-8503-4349-80ba-27612ad39445.html,,,,,, Dipotassium hexafluorotitanate,16919-27-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ec1f392-1d6f-4105-b790-95bb1bf5d11a/documents/IUC5-fca1c314-3a4a-49ae-abb7-9dd04709eea2_2fdc653f-8503-4349-80ba-27612ad39445.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,12.5 mg/kg bw/day,,rat Dipotassium hexafluorotitanate,16919-27-0," Acute oral toxicity: a key study is available, indicating a LD50 of 324 mg/kg, thus justifying classification as Category 4. Acute inhalation toxicity: Based on particle size considerations, incl. modelling on inhalability and fractional deposition in the respiratory tract, inhalation does not appear to be a relevant route of exposure for K2TiF6, and testing has been waived. Acute dermal toxicity: The physicochemical and toxicological properties of K2TiF6 do not suggest potential for a significant rate of absorption through the skin. Therefore, testing for acute dermal toxicity is not required. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ec1f392-1d6f-4105-b790-95bb1bf5d11a/documents/IUC5-19ca9a1c-08c2-4f43-af7a-e6020bf708ff_2fdc653f-8503-4349-80ba-27612ad39445.html,,,,,, Dipotassium hexafluorotitanate,16919-27-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ec1f392-1d6f-4105-b790-95bb1bf5d11a/documents/IUC5-19ca9a1c-08c2-4f43-af7a-e6020bf708ff_2fdc653f-8503-4349-80ba-27612ad39445.html,,oral,LD50,324 mg/kg bw,adverse effect observed, Dipotassium hexafluorozirconate,16923-95-8,"In rodents, repeated exposure to fluoride salts, such as sodium fluoride, causes alteration of teeth at daily doses of 4 mg NaF/kg bw/day or greater. Higher repeated doses of 10 and 25 mg NaF/kg bw/day increase dental effects as well as cause toxic effects in bone and the stomach. The severity of the toxic effects is related to increasing dose and duration of exposure. In a life-time chronic exposure study in the rats, an extremely high concentration of 175 ppm sodium fluoride in drinking water was associated with an increased incidence of osteosclerosis in female rats and equivocal evidence of osteosarcoma in male rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ddb51e5-3618-410e-baf9-b2412c901565/documents/IUC5-d7d1a8b8-b529-46d0-99f2-8da654e303fb_af1faecc-6087-403c-9a28-260e1a6a8d8a.html,,,,,, Dipotassium hexafluorozirconate,16923-95-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ddb51e5-3618-410e-baf9-b2412c901565/documents/IUC5-d7d1a8b8-b529-46d0-99f2-8da654e303fb_af1faecc-6087-403c-9a28-260e1a6a8d8a.html,Chronic toxicity – systemic effects,oral,LOAEL,11.2 mg/kg bw/day,,rat Dipotassium hexafluorozirconate,16923-95-8,"Acute oral toxicity: a key study is available, indicating a LD50 between 25 and 200 mg/kg, thus justifying classification as Category 3.Acute inhalation toxicity: Acute inhalation toxicity: Based on particle size considerations, incl. modelling on inhalability and fractional deposition in the respiratory tract, inhalation does not appear to be a relevant route of exposure for K2ZrF6, and testing has been waived.Acute dermal toxicity: The physicochemical and toxicological properties of K2ZrF6 do not suggest potential for a significant rate of absorption through the skin. Therefore, testing for acute dermal toxicity is not required. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ddb51e5-3618-410e-baf9-b2412c901565/documents/IUC5-7fdff58e-2836-4b27-98c1-52aa3d6b1ef6_af1faecc-6087-403c-9a28-260e1a6a8d8a.html,,,,,, Dipotassium hydrogen citrate,3609-96-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55e0ea26-74da-480b-afe4-9c5f64721a5c/documents/d42ec979-d96f-4788-97c0-761150d692c7_8defba6f-e87f-4074-a196-49b9232541f6.html,,oral,LD50,"5,400 mg/kg bw",adverse effect observed, Dipotassium methanedisulphonate,6291-65-2," Acute oral toxicity: Key study. Method according to OECD guideline 423, GLP study. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off may be considered to be 5000 mg/kg body weight by oral route in the rat. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce36cb25-21b9-4c46-be46-880f04a0f347/documents/e47c4e74-c356-4a97-aad7-d8b26cec6da2_490f3f1c-7ff5-43b5-be2b-e00137a40486.html,,,,,, Dipotassium methanedisulphonate,6291-65-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce36cb25-21b9-4c46-be46-880f04a0f347/documents/e47c4e74-c356-4a97-aad7-d8b26cec6da2_490f3f1c-7ff5-43b5-be2b-e00137a40486.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, dipotassium octaborate,12008-39-8,"A number of sub-chronic and chronic studies on boric acid and disodium tetraborate decahydrate were carried out in rats, mice and dogs. In some cases, these studies are research studies (Weir and Fisher, 1972; Dixon et al, 1976; Seal and Weeth, 1980; Lee et al., 1978; Treinen and Chapin, 1991; Ku et al., 1993), but most support that boron can cause adverse haematological effects and that the main target organ of boron toxicity is the testis. The NOAEL for fertility effects is equivalent to 17.5 mg B/kg bw/day (Weir, 1966) that corresponds to a NOAEL of 75.4 mg potassium octaborate/kg bw (anhydrous, and 90 mg potassium octaborate tetrahydrate/kg bw). Based on the sub-acute inhalation study on boron oxide conducted in rats (Wilding, 1960), the NOAEC for systemic effects is equivalent to 146 mg B/m3 that corresponds to a NOAEC of 629 mg potassium octaborate/m3 (anhydrous, and 750.6 mg potassium octaborate tetrahydrate/m3). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8a920e3-25c5-4694-89e4-7d7d54fcfcc3/documents/e49af89f-1031-4dcd-8be2-b7343068e1e7_9980a484-8618-4d0a-a4a0-49ca1310854e.html,,,,,, dipotassium octaborate,12008-39-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8a920e3-25c5-4694-89e4-7d7d54fcfcc3/documents/e49af89f-1031-4dcd-8be2-b7343068e1e7_9980a484-8618-4d0a-a4a0-49ca1310854e.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,629 mg/m3,,rat dipotassium octaborate,12008-39-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8a920e3-25c5-4694-89e4-7d7d54fcfcc3/documents/e49af89f-1031-4dcd-8be2-b7343068e1e7_9980a484-8618-4d0a-a4a0-49ca1310854e.html,Chronic toxicity – systemic effects,oral,NOAEL,75.4 mg/kg bw/day,,rat dipotassium octaborate,12008-39-8,"Acute oral studies have been performed with potassium tetraborate, disodium tetraborate, sodium tetraborate pentahydrate, sodium tetraborate decahydrate and boric acid. Acute dermal and inhalation studies have been performed with disodium tetraborate pentahydrate, disodium tetraborate decahydrate and boric acid. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8a920e3-25c5-4694-89e4-7d7d54fcfcc3/documents/4090ffe0-e9fb-43ce-af1a-c30bce9eeb17_9980a484-8618-4d0a-a4a0-49ca1310854e.html,,,,,, dipotassium octaborate,12008-39-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8a920e3-25c5-4694-89e4-7d7d54fcfcc3/documents/4090ffe0-e9fb-43ce-af1a-c30bce9eeb17_9980a484-8618-4d0a-a4a0-49ca1310854e.html,,oral,LD50,"2,943 mg/kg bw",no adverse effect observed, dipotassium octaborate,12008-39-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8a920e3-25c5-4694-89e4-7d7d54fcfcc3/documents/4090ffe0-e9fb-43ce-af1a-c30bce9eeb17_9980a484-8618-4d0a-a4a0-49ca1310854e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, dipotassium octaborate,12008-39-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8a920e3-25c5-4694-89e4-7d7d54fcfcc3/documents/4090ffe0-e9fb-43ce-af1a-c30bce9eeb17_9980a484-8618-4d0a-a4a0-49ca1310854e.html,,inhalation,LC50,"2,030 mg/m3",no adverse effect observed, Dipotassium phosphonate,13492-26-7, NOEL oral rat subacute > 1000 mg/Kg bw ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c4a2889-377b-46a4-8a66-166d3ad84de1/documents/902390c1-5b35-42ab-b745-f3a7570efe7f_fb896279-fe0b-4c22-94c7-dd6f0b8ad9f0.html,,,,,, Dipotassium phosphonate,13492-26-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c4a2889-377b-46a4-8a66-166d3ad84de1/documents/902390c1-5b35-42ab-b745-f3a7570efe7f_fb896279-fe0b-4c22-94c7-dd6f0b8ad9f0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dipotassium phosphonate,13492-26-7, LD50 Acute Oral rat > 2000 mg/Kg bw LD50 Acute Dermal rat > 5000 mg/Kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c4a2889-377b-46a4-8a66-166d3ad84de1/documents/1bb371be-beec-458c-889d-a1ab401f737b_fb896279-fe0b-4c22-94c7-dd6f0b8ad9f0.html,,,,,, Dipotassium phosphonate,13492-26-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c4a2889-377b-46a4-8a66-166d3ad84de1/documents/1bb371be-beec-458c-889d-a1ab401f737b_fb896279-fe0b-4c22-94c7-dd6f0b8ad9f0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dipotassium phosphonate,13492-26-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c4a2889-377b-46a4-8a66-166d3ad84de1/documents/1bb371be-beec-458c-889d-a1ab401f737b_fb896279-fe0b-4c22-94c7-dd6f0b8ad9f0.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Dipotassium propanedioate,13095-67-5, Oral LD50 (cut-off) = 5000 mg/kg bw/d ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b994fb91-1f36-449e-93ce-c78ddf2c7d4e/documents/01e464c5-b499-4dc0-b52d-11e866cdcbcf_ed7f79f7-4695-4530-8ef2-3af8594d5eb4.html,,,,,, Dipotassium tetrachloroplatinate,10025-99-7,"The acute oral LD50 of dipotassium tetrachloroplatinate was determined to be in the range of 50-200 mg/kg bw (Safepharm, 1981a).No relevant acute dermal or inhalation toxicity data were identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/217244d2-ddad-4be4-be96-8d899f8e233f/documents/IUC5-a1313c8d-a152-4990-8614-ad9439220892_fa18ca1a-6fc3-4001-8b3a-e46df19a2e85.html,,,,,, Dipotassium tetrachloroplatinate,10025-99-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/217244d2-ddad-4be4-be96-8d899f8e233f/documents/IUC5-a1313c8d-a152-4990-8614-ad9439220892_fa18ca1a-6fc3-4001-8b3a-e46df19a2e85.html,,oral,LD50,50 mg/kg bw,adverse effect observed, Dipotassium tetraoxomolybdate,13446-49-6, LD50 (oral) 4233 mg/kg bw (read-across from sodium molybdate) LD50 (oral) 3883 mg/kg bw (read-across from ammonium molybdate) LC50 (inhalation) >1.93 mg/L (read-across from sodium molybdate) LC50 (inhalation) >2.08 mg/L (read-across from ammonium molybdate) LD50 (dermal) >2000 mg/kg (read-across from sodium molybdate) LD50 (dermal) >2000 mg/kg (read-across from ammonium molybdate) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca314734-f0a6-4f3b-b40e-b161660e1ac7/documents/0816d854-1816-44fc-9dfb-939012a43f82_83e62726-53bc-40ca-9a21-3cff96f9f17d.html,,,,,, Dipotassium tetraoxomolybdate,13446-49-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca314734-f0a6-4f3b-b40e-b161660e1ac7/documents/0816d854-1816-44fc-9dfb-939012a43f82_83e62726-53bc-40ca-9a21-3cff96f9f17d.html,,oral,LD50,"3,883 mg/kg bw",adverse effect observed, Dipotassium tin hexahydroxide,12027-61-1," According to the relvant study for subacute chronic toxicity a NOAL of 1 % in diet was determined. Under consideration of a body of 250g / rat the folowing NOAEL could be calculated from the raw data: NOAEL (male( = 517.14 mg SnO2/kg bw day NOAEL(female) 408,57 mg SnO2 /kg bw day. So the female aninal is the most sensitive species, thus the NOAEL for Sodiums stabbate is 723.01 mg / kg /bw day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/712b8449-bee3-4dd0-b8f2-79ea371fad9b/documents/debfb2f8-a5a6-4994-8388-d6ee6f700b04_ecc2684b-4138-4f3c-b3c6-1dbe70220e5a.html,,,,,, Dipotassium tin hexahydroxide,12027-61-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/712b8449-bee3-4dd0-b8f2-79ea371fad9b/documents/debfb2f8-a5a6-4994-8388-d6ee6f700b04_ecc2684b-4138-4f3c-b3c6-1dbe70220e5a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,723.09 mg/kg bw/day,,rat Dipraseodymium dizirconium heptaoxide,12165-18-3," There is no experimental study available on the acute oral toxicity of the substance dipraseodymium dizirconium heptaoxide. However, based on a weight of evidence approach including experimental results obtained for the constituents, i.e. praseodymium(III,IV) oxide and zirconium dioxide, it can be concluded that the substance has a LD50 > 2000 mg/kg bw and does not need to be classified for acute oral toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05775714-6a94-4568-98c5-afa000dffbe2/documents/ff28e6ab-3c5b-49fb-95ee-6e9a5a162109_e6920b6b-17cc-493e-b588-13e1334514bc.html,,,,,, Dipraseodymium tricarbonate,5895-45-4,"An OECD 422 screening reproductive / developmental toxicity study (read-across from praseodymium (III,IV) oxide) has been conducted according to OECD test guideline number 422 using the oral exposure route. Under the conditions of this study the No Observed Adverse Effect Level (NOAEL) in Sprague-Dawley rats (male/female) was considered to be 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/628f014f-2eff-4401-873e-4ede5a5329f4/documents/IUC5-c23f5ee9-33d5-4ca1-b20f-24ebf9ea6bd7_07112c98-b905-4858-913f-bc277e827235.html,,,,,, Dipraseodymium tricarbonate,5895-45-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/628f014f-2eff-4401-873e-4ede5a5329f4/documents/IUC5-c23f5ee9-33d5-4ca1-b20f-24ebf9ea6bd7_07112c98-b905-4858-913f-bc277e827235.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dipraseodymium tricarbonate,5895-45-4,ACUTE TOXICITY: ORALThe LD50 of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.ACUTE TOXICITY: INHALATIONThe LC50 of the test material in the Wistar strain rat was found to be greater than 5.25 mg/L. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/628f014f-2eff-4401-873e-4ede5a5329f4/documents/IUC5-f1e5639c-38c9-42bb-81e0-9092f6cb0128_07112c98-b905-4858-913f-bc277e827235.html,,,,,, Dipraseodymium trioxide,12036-32-7, Repeated Dose Toxicity: Oral- Read-across performed with structurally similar substance. The No Observed Adverse Effect Level (NOAEL) in Sprague-Dawley rats was considered to be 1000 mg/kg/day for both males and females. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/71c01fdb-a8f4-49cc-bfbc-40262e2f2259/documents/61339ab1-23a3-4533-ac2f-0122f2e29f96_2820a580-2ac2-4e4a-82e3-9fb070a5601a.html,,,,,, Dipraseodymium trioxide,12036-32-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/71c01fdb-a8f4-49cc-bfbc-40262e2f2259/documents/61339ab1-23a3-4533-ac2f-0122f2e29f96_2820a580-2ac2-4e4a-82e3-9fb070a5601a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dipraseodymium trioxide,12036-32-7," Oral Toxicity: Read-across performed with structurally similar substance (Praseodymium (III,IV) Oxide) The oral LD50 (males and females) was >2000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on the results of this study according to EU criteria. Oral Toxicity: Read-across performed with structurally similar substance (Praseodymium Tricarbonate) The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight and as such requires no classification in accordance with EU criteria. Inhalation Toxicity: Read-across performed with structurally similar substance (Praseodymium (III,IV) Oxide) The 4 hour LC50 was determined to be > 5.21 mg/L, the test material therefore requires no classification in accordance with EU criteria. Inhalation Toxicity: Read-across performed with structurally similar substance (Praseodymium Tricarbonate) The 4 hour LC50 was therefore determined to be > 5.25 mg/L, the test material therefore requires no classification in accordance with EU criteria. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71c01fdb-a8f4-49cc-bfbc-40262e2f2259/documents/c495a2fd-3691-44d5-a9ec-27bd853f1bcf_2820a580-2ac2-4e4a-82e3-9fb070a5601a.html,,,,,, Dipraseodymium trioxide,12036-32-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71c01fdb-a8f4-49cc-bfbc-40262e2f2259/documents/c495a2fd-3691-44d5-a9ec-27bd853f1bcf_2820a580-2ac2-4e4a-82e3-9fb070a5601a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dipraseodymium trioxide,12036-32-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71c01fdb-a8f4-49cc-bfbc-40262e2f2259/documents/c495a2fd-3691-44d5-a9ec-27bd853f1bcf_2820a580-2ac2-4e4a-82e3-9fb070a5601a.html,,inhalation,LC50,5 mg/m3,no adverse effect observed, "dipropyl cyclohexane-1,2-dicarboxylate",65646-25-5, The acute median lethal oral dose (LD50) to rats of CHP was demonstrated to be greater than 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/784ff8c7-f1e7-4975-a6c2-d433826ff3f1/documents/IUC5-a85df468-a61f-4539-8f5d-658af4f2c51e_653e4b1a-a52e-41e7-9676-1257e8129df5.html,,,,,, "dipropyl cyclohexane-1,2-dicarboxylate",65646-25-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/784ff8c7-f1e7-4975-a6c2-d433826ff3f1/documents/IUC5-a85df468-a61f-4539-8f5d-658af4f2c51e_653e4b1a-a52e-41e7-9676-1257e8129df5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Dipropyl peroxydicarbonate,16066-38-9," Acute oral toxicity The single-dose oral toxicity of Lupersol 221 was evaluated in Sprague-Dawley rats (Douds, 1996a). An LD50 study was performed in which three groups of five male and five female rats received a single oral administration of the test article at graded dosage levels. Following dosing, the LD50 study rats were observed daily and weighed weekly. A gross necropsy examination was performed on all LD50 study animals at the time of death or scheduled euthanasia (day 14). Mortality occurred during the LD50 study as follows:   Dose Level (mg/kg) No. Dead/No. Dosed Males Females Combined 2000 015 1/5 1/10 3500 2/5 315 5/10 4500 415 515 9/10 All mortality occurred by study day 3. The most notable clinical abnormalities observed during the study included decreased activity, salivation, soft/mucoid stools, dark material around facial area, decreased/no defecation, diarrhea, gelatinous material on litter, fecal/urine stain, rough haircoat, wobbly gait, breathing abnormalities, piloerection, prostration, hunched posture, eyelids partially closed, and apparent hypothermia. The majority of these observations were noted in bath the animals that died and those surviving to study termination. ln the 2000 mg/kg and 3500 mg/kg dose groups, most of the notable observations were generally noted during the first 3-4 days following dosing with the exception of fecal/urine stain which were noted through days 8-9. The clinical observations in the surviving 4500 mg/kg male were generally noted through study day 10. Body weight gain was noted for all surviving animals during the test period. The most notable gross internal findings observed in the animals that died included abnormal content in the digestive tract and abdominal cavity, perforated stomach, reddened mucosa in the stomach and small intestine, firm and rubbery stomach, white foci on the liver, discoloration on internal viscera, and mottled liver. The most notable gross internal findings which were observed in the animals that survived included abnormal content and thickened mucosa in the stomach. Under the conditions of this test, the acute oral LD50 of Lupersol 221 in the sexes combined was determined to be 3158 mg/kg. Acute dermal toxicity The single-dose dermal toxicity of Lupersol 221 was evaluated on Sprague-Dawley rats (Douds, 19969b). A limit test was performed in which one group of five male and five female rats received a single dermal administration of the test article at a dose of 2000 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all limit test animals at the time of scheduled euthanasia (day 14). No mortality occurred during the limit test. The most notable clinical abnormalities observed during the study included transient incidences of dark material around the facial area and urine stain. Severe dermal irritation was noted at the site of test article application. Slight body weight loss was noted for two female rats during the study day 7- 14 body weight interval. Body weight gain was noted for all other animais during the test period. No gross internai findings were observed at necropsy on study day 14. Under the conditions of this test, the acute dermal LD0 of Lupersol 221 was estimated to be greater than 2000 mg/kg in the rat. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb155b88-bac0-43c2-a918-505cac6b5f58/documents/eace5e74-db26-4bf7-980d-ea3b259d164d_94a6cc70-cf6a-4e36-8864-0fbe431438c5.html,,,,,, Dipropyl peroxydicarbonate,16066-38-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb155b88-bac0-43c2-a918-505cac6b5f58/documents/eace5e74-db26-4bf7-980d-ea3b259d164d_94a6cc70-cf6a-4e36-8864-0fbe431438c5.html,,oral,LD50,"3,158 mg/kg bw",adverse effect observed, Dipropyl peroxydicarbonate,16066-38-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb155b88-bac0-43c2-a918-505cac6b5f58/documents/eace5e74-db26-4bf7-980d-ea3b259d164d_94a6cc70-cf6a-4e36-8864-0fbe431438c5.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Dipropylamine,142-84-7,Repeated dose toxicity: oralNOAEL: 300 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70a9b866-9688-492e-b072-99da06939b09/documents/IUC5-d814f6be-2f28-48ce-9b93-a38b2998fac7_8332d2a6-71ce-4063-b5f2-4ad93d9ffc0f.html,,,,,, Dipropylamine,142-84-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70a9b866-9688-492e-b072-99da06939b09/documents/IUC5-d814f6be-2f28-48ce-9b93-a38b2998fac7_8332d2a6-71ce-4063-b5f2-4ad93d9ffc0f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Dipropylamine,142-84-7,Acute Toxicity:- oral: LD50: 495 mg/kg bw (rat);- dermal: 925 mg/kg bw (rat);- inhalation: 4.4 mg/L air (rat); ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70a9b866-9688-492e-b072-99da06939b09/documents/IUC5-68b9269d-c0a3-407a-a7bd-5cfdefc8e2a4_8332d2a6-71ce-4063-b5f2-4ad93d9ffc0f.html,,,,,, Dipropylamine,142-84-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70a9b866-9688-492e-b072-99da06939b09/documents/IUC5-68b9269d-c0a3-407a-a7bd-5cfdefc8e2a4_8332d2a6-71ce-4063-b5f2-4ad93d9ffc0f.html,,oral,LD50,495 mg/kg bw,, Dipropylamine,142-84-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70a9b866-9688-492e-b072-99da06939b09/documents/IUC5-68b9269d-c0a3-407a-a7bd-5cfdefc8e2a4_8332d2a6-71ce-4063-b5f2-4ad93d9ffc0f.html,,dermal,LD50,925 mg/kg bw,, Dipropylamine,142-84-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70a9b866-9688-492e-b072-99da06939b09/documents/IUC5-68b9269d-c0a3-407a-a7bd-5cfdefc8e2a4_8332d2a6-71ce-4063-b5f2-4ad93d9ffc0f.html,,inhalation,LC50,"4,400 mg/m3",, Diquat dibromide,85-00-7,"- Oral: NOEL = 0.93 mg/kg bw/day for males/females, dog, 1-year, feeding, OECD 452, Hopkins 1990. Based on the findings from this study the NOEL is considered to be the NOAEL. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP compliant OECD 452 study ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ad026a5-bb1c-43fb-baf5-abd5281d8080/documents/ccb9530f-371e-4e91-bb91-dcfcabd75b6f_edec5c4e-c356-401f-9ccd-e103c3fa3513.html,,,,,, Diquat dibromide,85-00-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ad026a5-bb1c-43fb-baf5-abd5281d8080/documents/ccb9530f-371e-4e91-bb91-dcfcabd75b6f_edec5c4e-c356-401f-9ccd-e103c3fa3513.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.93 mg/kg bw/day,,dog Diquat dibromide,85-00-7," - Oral: LD50 = 400 mg/kg bw, male/female, rat, comparable to OECD401, McCall 1990. - Inhalation: LC50 = 0.226 mg/L, male/female, rat, comparable to OECD 403, Bruce 1985. - Dermal: LD50 > 792 mg/kg bw, male/female, rat,  comparable to OECD 402, McCall 1990. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ad026a5-bb1c-43fb-baf5-abd5281d8080/documents/6c1d49b4-3452-4501-80fd-ef6ccc0a13c7_edec5c4e-c356-401f-9ccd-e103c3fa3513.html,,,,,, Diquat dibromide,85-00-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ad026a5-bb1c-43fb-baf5-abd5281d8080/documents/6c1d49b4-3452-4501-80fd-ef6ccc0a13c7_edec5c4e-c356-401f-9ccd-e103c3fa3513.html,,oral,LD50,400 mg/kg bw,adverse effect observed, Diquat dibromide,85-00-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ad026a5-bb1c-43fb-baf5-abd5281d8080/documents/6c1d49b4-3452-4501-80fd-ef6ccc0a13c7_edec5c4e-c356-401f-9ccd-e103c3fa3513.html,,dermal,discriminating dose,> 792 mg/kg bw,no adverse effect observed, Diquat dibromide,85-00-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ad026a5-bb1c-43fb-baf5-abd5281d8080/documents/6c1d49b4-3452-4501-80fd-ef6ccc0a13c7_edec5c4e-c356-401f-9ccd-e103c3fa3513.html,,inhalation,LC50,0.226 mg/L,adverse effect observed, Dirhodium trioxide,12036-35-0, Haferkorn (2018) is a GLP compliant study assessing the acute oral toxicity of dirhodium trioxide according OECD 425. No mortality or pathological changes were apparent at the limit dose of 2000 mg/kg bw following the 14-day observation period while growth was unaffected. It was concluded that dirhodium trioxide does not require classification for acute oral toxicity according to EU CLP criteria (EC 1272/2008). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84282495-7a81-47cb-9b92-152b03382081/documents/34e1e965-bba8-4080-b9d2-12c9c0304bbd_63d29871-2705-42f1-a5b7-e933adccebd9.html,,,,,, Dirubidium oxide,18088-11-4, An acute oral toxicity study is not required since the substance is classified as corrosive to skin ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bb70c46-37d5-422c-b5ae-de31c306f819/documents/e4b3f92a-0060-453e-90b0-f9743bffc6d1_807c6aab-e23a-4c8c-b4e3-651b0de330e2.html,,,,,, "Di-sec-butylphenol, mixed isomers",5510-99-6,"Acute toxicity oral: LD50 in Sprague-Dawley rat >200-<2000 mg/kg body weight. Xn, R22. (OECD 203) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f011c201-bef8-4561-aa6b-5059ab7de4d7/documents/IUC5-065656d4-39b9-44dc-8a5a-ba2cf630e744_cb473206-7a75-4e5a-8cc2-969c267f4cfc.html,,,,,, "Di-sec-butylphenol, mixed isomers",5510-99-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f011c201-bef8-4561-aa6b-5059ab7de4d7/documents/IUC5-065656d4-39b9-44dc-8a5a-ba2cf630e744_cb473206-7a75-4e5a-8cc2-969c267f4cfc.html,,oral,LD50,200 mg/kg bw,, "Disilane, chloro Me derivs.",68937-17-7,"No acute toxicity data are available for Disilane, chloro Me derivs. However, based on the generation of hydrogen chloride in contact with water, this substance is classified as corrosive. In accordance with Column 2 of REACH Annexes VII and VIII, further testing for acute toxicity is therefore not required. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8419b08f-b5d8-4854-b537-15b42e8532aa/documents/IUC5-929ee3e2-d78d-420c-8bb4-9e84889e7a7d_223cb740-16a2-40b2-8c2c-5c10dc221b82.html,,,,,, "Disodium [(9,10-dihydro-9,10-dioxo-1,4-anthrylene)bis[imino(3-methylpropane-1,3-diyl)]]bis(benzenesulphonate)",70900-27-5,ORALLD50 >2000 mg/kg bodyweight in female rats ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e716ed13-91c0-4a13-98ef-e90ff0935ac0/documents/IUC5-e60e71ed-08e8-49a1-a4d5-197de460cf7d_c155fea6-5d06-4926-aec6-f45d73d49839.html,,,,,, "Disodium [[4-[bis[4-[(sulphonatophenyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate",28983-56-4," Prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound Disodium [[4-[bis[4-[(sulphonatophenyl) amino]phenyl] methylene]cyclohexa-2,5-dien-1-ylidene]amino]ben..(28983-56-4 ). The study assumed the use of male and female Wistar strain in Subchronic study. No significant alterations were noted at the dose level of 815.90mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for compound Disodium [[4-[bis[4-[(sulphonatophenyl) amino]phenyl] methylene]cyclohexa-2,5-dien-1-ylidene]amino]ben..is considered to be 815.90mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a033c35f-23ee-4f8f-a74a-7b1ea8f3bcda/documents/ca7c79ae-5bf6-435a-8a01-e28fce7e02fa_008e74ef-97b9-44a9-b3c1-6843188a3598.html,,,,,, "Disodium [[4-[bis[4-[(sulphonatophenyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate",28983-56-4,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a033c35f-23ee-4f8f-a74a-7b1ea8f3bcda/documents/ca7c79ae-5bf6-435a-8a01-e28fce7e02fa_008e74ef-97b9-44a9-b3c1-6843188a3598.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,815.9 mg/kg bw/day,,rat "Disodium [[4-[bis[4-[(sulphonatophenyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate",28983-56-4," Acute oral toxicity:  Acute oral toxicity dose (LD50) of Disodium [[4-[bis[4-[(sulphonatophenyl)amino] phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate (CAS no: 28983-56-4) was predicted based on OECD QSAR toolbox 9957 mg/kg bw and different studies available on structurally similar read across substances Disodium 4-hydroxy-3-[(4-sulfonato-1-naphthyl)diazenyl]naphthalene-1-sulfonate (CAS no: 3567-69-9) 4166.66 mg/kg bw and Trisodium 3-hydroxy-4-(4'-sulphonatonaphthylazo) naphthalene-2,7-disulphonate (CAS no: 915-67-3) >2000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Disodium [[4-[bis[4-[(sulphonatophenyl)amino] phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]amino] benzenesulphonate cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  [[4-[bis[4-[(sulphonatophenyl)amino]phenyl]methylene] cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate (CAS no: 28983-56-4) has very low vapour pressure (5.89E-44 mm Hg), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for [[4-[bis[4-[(sulphonatophenyl)amino]phenyl] methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate (CAS no: 28983-56-4) was predicted based on OECD QSAR toolbox 7167 mg/kg bw and different studies available for the structurally similar read across substances [4-[[4-anilino-1-naphthyl][ 4-(dimethylamino)phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]dimethylammonium acetate (CAS No. 83803-79-6) >2000 mg/kg bw and Disodium 4-hydroxy-3- [(4-sulfonato-1-naphthyl)diazenyl]naphthalene-1-sulfonate (3567-69-9) >2000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, [[4-[bis[4-[(sulphonatophenyl)amino]phenyl] methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate cannot be classified for acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a033c35f-23ee-4f8f-a74a-7b1ea8f3bcda/documents/d67deb82-fa56-46ab-8736-9a450ae4c719_008e74ef-97b9-44a9-b3c1-6843188a3598.html,,,,,, "Disodium [[4-[bis[4-[(sulphonatophenyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate",28983-56-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a033c35f-23ee-4f8f-a74a-7b1ea8f3bcda/documents/d67deb82-fa56-46ab-8736-9a450ae4c719_008e74ef-97b9-44a9-b3c1-6843188a3598.html,,oral,LD50,"9,957 mg/kg bw",no adverse effect observed, "Disodium [[4-[bis[4-[(sulphonatophenyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene]amino]benzenesulphonate",28983-56-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a033c35f-23ee-4f8f-a74a-7b1ea8f3bcda/documents/d67deb82-fa56-46ab-8736-9a450ae4c719_008e74ef-97b9-44a9-b3c1-6843188a3598.html,,dermal,LD50,"7,167 mg/kg bw",no adverse effect observed, "Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']magnesate(2-)",14402-88-1,"Several repeated oral toxicity studies were available for EDTA-CaNa2; results of these studies were compared with studies with other metal chelates and with EDTA (see below). One repeated inhalation toxicity study was avalaible for DTPA-CaNa3, another, Ca-containing chelate. Several ip and iv studies were also available showing various effects but mostly on kidneys. However, as workers and consumers are not exposed via these non-physiological routes these studies are not further taken into account. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/81e4bbcb-6fb1-4502-9fc4-ddf8134312fd/documents/IUC5-095f4378-55bb-4377-80de-0459bf3fb510_69f1ce8f-8065-46ca-aeb3-4923af91d8b5.html,,,,,, "Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']magnesate(2-)",14402-88-1,The LD50 value in rats was in excess of 2000 mg/kg bw. Exposure to other chelates did not show inhalation or dermal toxicity. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81e4bbcb-6fb1-4502-9fc4-ddf8134312fd/documents/IUC5-9c3326d1-1519-460d-b282-6b76590becb2_69f1ce8f-8065-46ca-aeb3-4923af91d8b5.html,,,,,, "Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']manganate(2-)",15375-84-5,"An oral study with EDTA-MnNa2 in which males were treated for at least 12 weeks and females for almost 14 weeks showed effects on water intake, urinary sodium concentration, increased kidney weight and slight histopathological renal changes. Four repeated oral toxicity studies were available for EDTA-CaNa2; results of these studies were compared with studies with other metal chelates and with EDTA (see below). One repeated inhalation toxicity study was avalaible for DTPA-CaNa3. Several ip and iv studies were also available showing various effects but mostly on kidneys. However, as workers and consumers are not exposed via these non-physiological routes these studies are not further taken into account. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9db2d748-adaf-4e85-ab1b-09a22233894d/documents/IUC5-fe9ea573-bf91-4510-938f-93985a87c15a_b57f2082-5253-4da7-8e30-be2821395a85.html,,,,,, "Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']manganate(2-)",15375-84-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9db2d748-adaf-4e85-ab1b-09a22233894d/documents/IUC5-fe9ea573-bf91-4510-938f-93985a87c15a_b57f2082-5253-4da7-8e30-be2821395a85.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Disodium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']manganate(2-)",15375-84-5,The acute oral toxicity test did not show mortality at a limit dose of 2000 mg/kg bw and the 4-h inhalation toxicity study did not show mortality at the limit concentration of 5000 mg/m3. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9db2d748-adaf-4e85-ab1b-09a22233894d/documents/IUC5-95a2f33e-25e8-432e-a6cd-a8f08211a621_b57f2082-5253-4da7-8e30-be2821395a85.html,,,,,, "Disodium [[N,N'-ethylenediylbis[N-(carboxylatomethyl)glycinato]](4-)-N,N',O,O',ON,ON']zincate(2-)",14025-21-9,"With regard to the evaluation of repeated dose toxicity for EDTA-ZnNa2, results of the study with EDTA-CaNa2 were compared with studies with other metal chelates and with EDTA (see below). One repeated inhalation toxicity study was avalaible for DTPA-CaNa3, another, Ca-containing chelate.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88a80732-b972-4d08-a717-5fb6f0b26c66/documents/IUC5-811ed3b9-960c-4e68-bac0-46bf870bbf75_d36fccb5-a3d9-419b-b511-f29f9f32f0df.html,,,,,, "Disodium [[N,N'-ethylenediylbis[N-(carboxylatomethyl)glycinato]](4-)-N,N',O,O',ON,ON']zincate(2-)",14025-21-9,"The acute oral LD50 value in rats was > 2000 mg/kg bw. Although an acute inhalation with this substance was not performed, inhalation studies with other metal chelates showed that these substances are not toxic (4-h LC50 value > 5 mg/L or at the maximally attanaible concentration). In addition, acute dermal toxicity studies with other metal chelates showed that LD50 values were in excess of 2000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The key study was conducted according to GLP and guidelines. Sufficient data is available also for the other metal-chelates (see also read across document in section 13) for the interpretation of study results. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Other studies with metal-chelates of EDTA (EDTA-MnNa2, EDTA-FeNa, EDTA-CuNa2) showed very limited acute toxicity (4-h LC50 > 5 mg/L). In addition, a study with Ca-DTPA showed a 2-h LC50 > 1.15 mg/L. See also read across document in section 13. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Other studies with metal-chelates of EDTA (EDTA-Fe(NH4)2OH, EDTA-FeNa) showed very limited acute toxicity (LD50 > 2000 mg/kg bw). See also read across document in section 13. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88a80732-b972-4d08-a717-5fb6f0b26c66/documents/IUC5-8d3d4f6b-fa90-4c97-8926-753c94504ad9_d36fccb5-a3d9-419b-b511-f29f9f32f0df.html,,,,,, "Disodium [1-[(2-hydroxy-3,5-dinitrophenyl)azo]-2-naphtholato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)",70236-55-4,"acute oral toxicity, rat (M/f), gavage, > 8000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17034303-7229-42a8-8800-13ad3098e9ac/documents/IUC5-0f9b331a-21a1-4a2d-8ae0-e0f3231336c7_322aef89-084d-4cad-bdaf-0b116915266b.html,,,,,, "Disodium [1-[(2-hydroxy-3,5-dinitrophenyl)azo]-2-naphtholato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)",70236-55-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17034303-7229-42a8-8800-13ad3098e9ac/documents/IUC5-0f9b331a-21a1-4a2d-8ae0-e0f3231336c7_322aef89-084d-4cad-bdaf-0b116915266b.html,,oral,LD50,"8,000 mg/kg bw",no adverse effect observed, "Disodium [2,2'-bi-1H-indole]-3,3'-diolate",894-86-0,There were no adverse effects noted up to the highest dose levels tested ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8cfc5d74-d5b5-4c26-9b59-30fefc84a219/documents/IUC5-91716032-4bc6-4cd7-bfef-9c15884db3a9_1d512c97-f8b9-4164-837b-36c772fe1ad3.html,,,,,, "Disodium [2,2'-bi-1H-indole]-3,3'-diolate",894-86-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8cfc5d74-d5b5-4c26-9b59-30fefc84a219/documents/IUC5-91716032-4bc6-4cd7-bfef-9c15884db3a9_1d512c97-f8b9-4164-837b-36c772fe1ad3.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,200 mg/kg bw/day",,rat "Disodium [2,2'-bi-1H-indole]-3,3'-diolate",894-86-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8cfc5d74-d5b5-4c26-9b59-30fefc84a219/documents/IUC5-91716032-4bc6-4cd7-bfef-9c15884db3a9_1d512c97-f8b9-4164-837b-36c772fe1ad3.html,Chronic toxicity – systemic effects,dermal,NOAEL,25 mg/kg bw/day,,mouse "Disodium [2,2'-bi-1H-indole]-3,3'-diolate",894-86-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8cfc5d74-d5b5-4c26-9b59-30fefc84a219/documents/IUC5-12fb45f0-d0a7-4364-96a4-fe5aacb79dfd_1d512c97-f8b9-4164-837b-36c772fe1ad3.html,,oral,LD50,"4,430 mg/kg bw",adverse effect observed, "Disodium [2,2'-bi-1H-indole]-3,3'-diolate",894-86-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8cfc5d74-d5b5-4c26-9b59-30fefc84a219/documents/IUC5-12fb45f0-d0a7-4364-96a4-fe5aacb79dfd_1d512c97-f8b9-4164-837b-36c772fe1ad3.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, "Disodium [2,2'-bi-1H-indole]-3,3'-diolate",894-86-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8cfc5d74-d5b5-4c26-9b59-30fefc84a219/documents/IUC5-12fb45f0-d0a7-4364-96a4-fe5aacb79dfd_1d512c97-f8b9-4164-837b-36c772fe1ad3.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)",70236-60-1," Oral NOAEL: 180 mg/kg bw/day (subacute, rats) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce142d8d-2f20-4599-b3e9-ba4fae5fe25f/documents/IUC5-06f1f91f-a1e9-4cd3-8719-584e52c18888_34a6078c-7e58-4a21-8d03-f414145c15ee.html,,,,,, "Disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)",70236-60-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce142d8d-2f20-4599-b3e9-ba4fae5fe25f/documents/IUC5-06f1f91f-a1e9-4cd3-8719-584e52c18888_34a6078c-7e58-4a21-8d03-f414145c15ee.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,180 mg/kg bw/day,,rat "Disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)",70236-60-1,Oral LD50 > 2500 mg/kg bwDermal LD50 > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce142d8d-2f20-4599-b3e9-ba4fae5fe25f/documents/IUC5-1e5946b8-8720-4eac-b798-9f207406e281_34a6078c-7e58-4a21-8d03-f414145c15ee.html,,,,,, "Disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)",70236-60-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce142d8d-2f20-4599-b3e9-ba4fae5fe25f/documents/IUC5-1e5946b8-8720-4eac-b798-9f207406e281_34a6078c-7e58-4a21-8d03-f414145c15ee.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "Disodium [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)",70236-60-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce142d8d-2f20-4599-b3e9-ba4fae5fe25f/documents/IUC5-1e5946b8-8720-4eac-b798-9f207406e281_34a6078c-7e58-4a21-8d03-f414145c15ee.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Disodium [2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-),84145-95-9,The acute oral LD50 of FAT 20013 was found to be greater than 5000 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0f7b840-06c0-4d97-86e8-44b48cd756a0/documents/147f1268-db12-4406-9e3d-d871a21c5d52_d55d0d6a-b5e3-4ab3-a871-65f6e020ea55.html,,,,,, Disodium [2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-),84145-95-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0f7b840-06c0-4d97-86e8-44b48cd756a0/documents/147f1268-db12-4406-9e3d-d871a21c5d52_d55d0d6a-b5e3-4ab3-a871-65f6e020ea55.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzenesulphonato(3-)][1-[[2-hydroxy-5-(phenylazo)phenyl]azo]-2-naphtholato(2-)]chromate(2-)",52587-68-5,The acute oral LD50 of FAT 21095/A in rats of both sexes observed over a period of 14 days is 5404 mg/kg. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a446c3d3-6ebe-4e48-8b0c-abf7aa00fa12/documents/IUC5-892c4f65-acfb-42a2-bf99-799635fdc37a_2f25f802-1f45-470b-912b-d1e20662a1fc.html,,,,,, "Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzenesulphonato(3-)][1-[[2-hydroxy-5-(phenylazo)phenyl]azo]-2-naphtholato(2-)]chromate(2-)",52587-68-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a446c3d3-6ebe-4e48-8b0c-abf7aa00fa12/documents/IUC5-892c4f65-acfb-42a2-bf99-799635fdc37a_2f25f802-1f45-470b-912b-d1e20662a1fc.html,,oral,LD50,"5,404 mg/kg bw",no adverse effect observed, "Disodium [3-[4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonato(3-)][1-[[2-hydroxy-5-(phenylazo)phenyl]azo]-2-naphtholato(2-)]chromate(2-)",70236-62-3,LD50 (male/female)= 5437 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d81122d2-e223-444b-8641-7408f6ad2db1/documents/IUC5-563ab278-d7c1-4c84-b3ae-3a6a49b9d99e_5bf99813-5715-4988-a694-f1a51ff66fac.html,,,,,, "Disodium [3-[4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonato(3-)][1-[[2-hydroxy-5-(phenylazo)phenyl]azo]-2-naphtholato(2-)]chromate(2-)",70236-62-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d81122d2-e223-444b-8641-7408f6ad2db1/documents/IUC5-563ab278-d7c1-4c84-b3ae-3a6a49b9d99e_5bf99813-5715-4988-a694-f1a51ff66fac.html,,oral,LD50,"5,437 mg/kg bw",no adverse effect observed, Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-),68541-71-9," Oral: FAT 20011/E was assessed for potential to cause systemic toxicity when administered repeatedly for at least four weeks in a combined repeated dose toxicity study with reproductive/developmental screening. Three groups rats, with each containing 10 males and 10 females, received FAT 20011/E TE at doses of 100, 330 or 1000 mg/kg/day by oral gavage administration. There were no clinical signs attributed to FAT 20011/E TE and there were considered to be no adverse changes detected for sensory reactivity and grip strength assessments, motor activity, body weight performance (females only), food consumption, haematology or blood chemistry parameters assessed and, organ weights.It was therefore concluded that in the absence of any evidence for general systemic toxicity that the no observed adverse effect level of FAT 20011/E was 1000 mg/kg/day. Inhalation: According to Annex VIII to Regulation EC No 1907/2006 testing does not appear scientifically necessary. The substance is unlikely to be inhaled for the following reasons: The organic substance has a very low vapour pressure, a high melting point (>330 °C). The potential for the generation of inhalable forms is considered to be low. The use of this substance will not result in aerosols, particles or droplets of an inhalable size, so the exposure to humans via inhalation will be unlikely to occur. Following repeated oral application, the test substance did not exacerbate any systemic toxicity effects. Results from the toxicokinetics studies confirmed that upon oral administration the substance is rapidly and completely excreted without potential for bioaccumulation. Taken together, due to the good water solubility of 2 g/liter oral ingestion and subsequent gastro-intestinal absorption is considered to be the most relevant route of exposure. Since this route does not result in systemic toxicity up to 1500 mg/kg in female rats, systemic toxic effects subsequent to inhalation exposure is considered to be unlikely to occur. Therefore, the study will be waived and the intrinsic property/toxicity potential can be extrapolated from the repeated oral route administration.  Exposure considerations for workers, professionals and consumers:  Production and spray drying is performed in closed processes without isolation of reaction products. Isolated products consist either of liquid formulations or of dust free granules (non-dusty solid). In addition, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Risk management measures established for workers and professionals are considered sufficient to enable safe handling and use of the final products containing the formulated dye. Products for consumers are currently not marketed. Dermal: According to Annex VIII to Regulation EC No 1907/2006 testing does not appear scientifically necessary. Following repeated oral application, the test substance did not exacerbate any systemic toxicity effects. In addition, the physicochemical and toxicological properties suggest a low potential for significant rate of absorption through the skin. Results from the toxicokinetics studies confirmed that upon oral administration the substance is rapidly and completely excreted without potential for bioaccumulation. Taken together, due to the good water solubility of 2 g/liter oral ingestion and subsequent gastro-intestinal absorption is considered to be the most relevant route of exposure. Since this route does not result in systemic toxicity up to 1500 mg/kg in female rats, systemic toxic effects subsequent to dermal exposure is considered to be unlikely to occur. Therefore, the study will be waived and the intrinsic property/toxicity potential can be extrapolated from the repeated oral route administration.  Exposure considerations for workers, professionals and consumers:  Production and spray drying is performed in closed processes without isolation of reaction products. Isolated products consist either of liquid formulations or of dust free granules (non-dusty solid). In addition, the use of this substance will not result in aerosols, particles or droplets, so exposure to humans via the dermal route will be unlikely to occur. Risk management measures established for workers and professionals are considered sufficient to enable safe handling and use of the final products containing the formulated dye. Products for consumers are currently not marketed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea303df4-23a6-40d3-a1a5-edf0d1108271/documents/IUC5-d7f18ec2-7aa0-488e-a6c9-388508f0772c_cbff47b1-fd93-4cc0-bce1-20b3fb2224fd.html,,,,,, Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-),68541-71-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea303df4-23a6-40d3-a1a5-edf0d1108271/documents/IUC5-d7f18ec2-7aa0-488e-a6c9-388508f0772c_cbff47b1-fd93-4cc0-bce1-20b3fb2224fd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-),68541-71-9," Oral: In total four acute oral toxicity studies performed according to OECD testing guidelines are available. The key study was performed to assess the acute oral toxicity of FAT 20011/E in the Wistar strain rats., according to OECD Guideline 420 and EU Method B.1. Following a sighting test at a dose level of 3077 mg/kg (equivalent to 2000 mg active ingredient/kg bw) in one female rat, an additional four fasted female animals were given a single oral dose of test item, as a solution in distilled water, at a dose level of 3077 mg/kg bw ( equivalent to 2000 mg active ingredient/kg bw). No deaths were observed during the course of study. There were no signs of systemic toxicity. Blue or blue/black colored staining of the feces was noted in all animals. Blue colored staining of the urine was also noted in the four additional treated animals. All animals showed expected gains in body weight. No abnormalities were noted at necropsy of the initial treated animal. Patchy pallor of the liver and dark kidneys were noted at necropsy of the four additional treated animals.Based on these findings, the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 3077 mg/kg body weight (equivalent to 2000 mg/kg active ingredient/kg body weight) (Globally Harmonized Classification System - Unclassified). In another experiment considered as supporting study and performed in 1994 to determine the acute oral toxicity of FAT 2001/D (purity 52.5 %), a group of rats (5/sex) were gavaged at 2000 mg/kg bw and observed over a period of 14 days. Within 2 hours after treatment, the rats showed piloerection, hunched posture and dyspnoea, but recovered within 3 days. No substance related gross organ changes were noted. Based on these findings, the acute oral LD50 of FAT 20011/D in rats of both sexes observed over a period of 14 days is greater than 2000 mg/kg bw (based on test material). In a supporting study performed in 1974 to determine the acute toxicity of FAT 20011/A (purity 40 %) according to a methodology similar to OECD Guideline 401 (Acute Oral Toxicity), a group of rats containing 5 males and 5 females were administered the test item at 5000 mg/kg bw. No mortality was observed. Signs of reaction to treatment, observed shortly after treatment, included lethargy, piloerection, diuresis and diarrhoea. The urine and faeces of all rats were stained blue. Recovery of all animals, as judged by external appearance and behaviour, was apparently complete two days after treatment. This observation was substantiated by normal bodyweight increases compared with controls. Autopsy findings were normal. In conclusion, the acute oral LD50 of FAT 20011/A in rats of both sexes, observed over a period of 14 days is greater than 5000 mg/kg. In the study performed in 1982 to determine the acute oral toxicity of FAT 20011/C (purity 52.5 %), groups of rats (5/sex/dose) received the test item at 1000, 2500 and 5000 mg/kg bw. Within 2 hours after treatment, rats of all dosage groups showed piloerection, hunched posture and dyspnea, but recovered within 3 days in the mid (except one female) and low dose groups. In the high dose group death rates of 60 % in males and 100 % in females occurred. In addition one female of the mid dose group also died within the first day post treatment. No gross pathological changes have been noted neither in the animals died subsequently to test substance administration nor in the survivors. Based on the findings of the study, the acute oral LD50 of FAT 20011/C in male rats is >2500, in female rats is 2800 and rats of both sexes observed over a period of 14 days is 3644 mg/kg bw (based on test material). Taking all available data from the above studies into account, the LD50 for acute oral toxicity is set to 2000 mg/kg bw.   Inhalation: Currently no study to assess the acute inhalation toxicity potential of Acid Blue 317 is available. However, the vapour pressure for the target chemical is low owing to the high melting point >330 °C, hence it can be considered to have low volatility. Synthesis and spray drying of this chemical is performed in a closed process; the final product consists of non-dusty granules. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Further, the chemical was found to have low acute toxicity when tested via oral route with no mortality when tested upto 2000 mg/kg bw. Hence, considering all the above arguments, it is considered that Acid Blue 317 has a low toxicity potential via inhalation route and thus the study on acute inhalation toxicity is considered scientifically not necessary.   Dermal: Currently no study to assess acute dermal toxicity of Acid Blue 317 is available. However, the molecular weight of the chemical is 791.55 g/mol, indicating low potential for dermal absorption. The chemical showed low toxicity potential in the available acute oral toxicity studies (LD50 >2000 mg/kg bw). Similarly, absence of systemic toxicity in skin irritation as well as sensitization studies, further supports the conclusion that no adverse effects are expected via the dermal route. Further experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the chemical only show up upon dermal exposure and not after systemic application. Hence, low toxicity is expected on acute dermal exposure of Acid Blue 317 and testing by the dermal route was considered scientifically not necessary. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea303df4-23a6-40d3-a1a5-edf0d1108271/documents/IUC5-d2d33c4b-12e6-40a5-9db2-d65abc2d3747_cbff47b1-fd93-4cc0-bce1-20b3fb2224fd.html,,,,,, Disodium [4-hydroxy-3-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-1-sulphonato(3-)][1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(2-),68541-71-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea303df4-23a6-40d3-a1a5-edf0d1108271/documents/IUC5-d2d33c4b-12e6-40a5-9db2-d65abc2d3747_cbff47b1-fd93-4cc0-bce1-20b3fb2224fd.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzene-1-sulphonato(4-)]hydroxychromate(2-)",6408-31-7," Acute oral toxicity:  Acute oral toxicity dose (LD50) for Disodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzene-1-sulphonato(4-)] hydroxychromate(2-) (CAS no: 6408-31-7) was predicted based on OECD QSAR toolbox 4863 mg/kg bw and different studies available on structurally similar read across substances Trisodium 5-hydroxy-1-(4-sulphophenyl)-4-(4-sulphophenylazo)pyrazole-3-carboxylate (1934-21-0) >6250 mg/kg bw and Disodium 2,5-dichloro-4-(5-hydroxy-3-methyl-4-(sulphophenylazo)pyrazol-1-yl)benzenesulphonate (6359-98-4) >5000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Disodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl) -1H-pyrazol-4-yl]azo]-2-hydroxybenzene-1-sulphonato(4-)]hydroxychromate(2-) cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: Disodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzene-1-sulphonato(4-)]hydroxychromate(2-) (CAS no: 6408-31-7) has very low vapor pressure (4.53E-21 Pa at 25°C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c05ec8bc-d4a4-4730-92ca-277f20311caf/documents/7cb4595e-a688-4799-97a3-f0873813fb6a_92fd3f0f-5e8a-4485-8ed9-4d44f3840a6d.html,,,,,, "Disodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzene-1-sulphonato(4-)]hydroxychromate(2-)",6408-31-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c05ec8bc-d4a4-4730-92ca-277f20311caf/documents/7cb4595e-a688-4799-97a3-f0873813fb6a_92fd3f0f-5e8a-4485-8ed9-4d44f3840a6d.html,,oral,LD50,"4,863 mg/kg bw",no adverse effect observed, "Disodium [6-[(2-anilino-1-naphthyl)azo]-2,4-dinitrophenolato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(2-)",75214-65-2, Oral LD50 > 2500 - 3000 mg/kg bw (males and females) (based on active ingredient) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e367d3c7-e9f5-4800-a97a-3634786e178b/documents/c056c853-e567-44fa-8979-e90a96c8d54f_f7912929-8a29-4c84-a17a-1fcbad4a4d88.html,,,,,, Disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)][6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-2-sulphonato(3-)]cobaltate(2-),75314-27-1," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target substance Disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)] [6-amino-5- [(2-hydroxy-4-nitrophenyl) azo]naphthalene-2-sulphonato(3-)]cobaltate(2-) (75314-27-1) was estimated to be 2711.4 mg/kg bw,and for differentstudies available on the structurally similar read across substance Aluminium, 6-hydroxy-5-[(4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (CAS No. – 15790-07-5) was considered to be >2000 mg/kg bw and for Allura red (25956-17-6) was considered to be >2000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)] [6-amino-5- [(2-hydroxy-4-nitrophenyl) azo]naphthalene-2-sulphonato(3-)]cobaltate(2-) (75314-27-1) cannot be classified for acute oral toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a66b9f35-8372-4221-a111-e5410f37cd33/documents/b3659064-adbb-44e4-902b-87d8ea681ce0_dcf8d6f2-6cc9-481b-bcc3-0c6ce69e5dcc.html,,,,,, Disodium [6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]-N-methylnaphthalene-2-sulphonamidato(2-)][6-amino-5-[(2-hydroxy-4-nitrophenyl)azo]naphthalene-2-sulphonato(3-)]cobaltate(2-),75314-27-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a66b9f35-8372-4221-a111-e5410f37cd33/documents/b3659064-adbb-44e4-902b-87d8ea681ce0_dcf8d6f2-6cc9-481b-bcc3-0c6ce69e5dcc.html,,oral,LD50,"2,711.4 mg/kg bw",no adverse effect observed, Disodium [N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-),72403-66-8, Acute administration by oral route LD50 > 5000 mg/kg body weight. Acute administration by dermal route LD50 > 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43308193-1ebb-4f02-9ded-cef12f0a73aa/documents/IUC5-f588a6f1-f704-4a00-8940-2e45bbbe9cda_55fe9bd9-c1d5-465f-89e1-584ea903dd31.html,,,,,, Disodium [N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-),72403-66-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43308193-1ebb-4f02-9ded-cef12f0a73aa/documents/IUC5-f588a6f1-f704-4a00-8940-2e45bbbe9cda_55fe9bd9-c1d5-465f-89e1-584ea903dd31.html,,oral,LD50,"7,993 mg/kg bw",no adverse effect observed, Disodium [N-(2-chlorophenyl)-2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-),72403-66-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43308193-1ebb-4f02-9ded-cef12f0a73aa/documents/IUC5-f588a6f1-f704-4a00-8940-2e45bbbe9cda_55fe9bd9-c1d5-465f-89e1-584ea903dd31.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "disodium [N, 2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)",164651-56-3, Acute administration by oral route LD50 > 5000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ca3b248-8743-4204-a06e-5ba806d0165d/documents/86a0817a-f71a-477d-b48b-e1dc826fc00d_f06d51f4-b48d-480d-bb9c-5522ecd6d386.html,,,,,, "disodium [N, 2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)",164651-56-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ca3b248-8743-4204-a06e-5ba806d0165d/documents/86a0817a-f71a-477d-b48b-e1dc826fc00d_f06d51f4-b48d-480d-bb9c-5522ecd6d386.html,,oral,LD50,"7,993 mg/kg bw",no adverse effect observed, "Disodium [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]ferrate(2-)",19529-38-5," In an extended oral OECD 422 study with the structurally related chelate DTPA-FeHNa male animals were exposed for at least 13 weeks and females for almost 14 weeks. At the high dose level the following effects were observed: soft faeces (both sexes), decreased body weight gain (males), prolonged prothrombin time (males), increased haemoglobin concentration (males), decreased ALAT activity and chloride concentration (males) and increased relative weights of kidneys and liver (both sexes). No toxicologically relevant changes were observed at the lower levels of 500 and 150 mg/kg bw (see also read across document in section 13). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51cb86da-2a43-437e-82b1-c112e5dbda3a/documents/IUC5-25a82d0b-7d1e-4b49-8230-c505151d6a2f_7fd61a7d-2274-4db5-ad06-48668e1ab4e7.html,,,,,, "Disodium [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]ferrate(2-)",19529-38-5,"The oral LD50 value is in excess of 2000 mg/kg bw; the 4-h LC50 value of structurally related substances is in excess of 5 g/m3. No acute dermal toxicity studies are available but based on read across (see also section 13), acute dermal toxicity following exposure to DTPA-FeNa2 is not expected. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51cb86da-2a43-437e-82b1-c112e5dbda3a/documents/IUC5-d5257d0e-128d-4f2b-8318-425ecc6475ac_7fd61a7d-2274-4db5-ad06-48668e1ab4e7.html,,,,,, Disodium [N-[7-hydroxy-8-[(2-hydroxy-5-mesylphenyl)azo]-1-naphthyl]acetamidato(2-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(2-),55039-14-0, The acute oral LD50 in rats 5000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87b42c1c-ca3a-45b0-9328-b883549e3763/documents/857fa9a0-89f0-4c53-bae6-b564f1970b37_75758f7e-32be-4ece-89e1-dd1c47de270b.html,,,,,, Disodium [N-[7-hydroxy-8-[(2-hydroxy-5-mesylphenyl)azo]-1-naphthyl]acetamidato(2-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(2-),55039-14-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87b42c1c-ca3a-45b0-9328-b883549e3763/documents/857fa9a0-89f0-4c53-bae6-b564f1970b37_75758f7e-32be-4ece-89e1-dd1c47de270b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Disodium [μ-[[7,7'-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-)",6798-03-4," Acute oral toxicity:  Acute oral toxicity dose (LD50) of disodium [μ-[[7,7'-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-)(CAS no: 6798-03-4) was predicted based on OECD QSAR toolbox, the value estimated to be 7884 mg/kg bw and different studies available on structurally similar read across substances Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo)) naphthalene-4,6-disulphonate (CAS No. 2519-30-4), the LD50 was considered to be >2000 mg/kg bw and Trisodium 3-hydroxy-4-(4'-sulphonatonaphthylazo) naphthalene-2,7- disulphonate (CAS no: 915-67-3), the LD50 was considered to be >2000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, disodium [μ-[[7,7'-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl] azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) cannot be classified for acute oral toxicity. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for disodium [μ-[[7,7'-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl] azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-)(CAS no: 6798-03-4) was predicted based on OECD QSAR toolbox, the value estimated to be 11253 mg/kg bw and different studies available for the structurally similar read across substances Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate (CAS No. 2519-30-4) LD50 was considered to be >2000 mg/kg bw and Disodium 4-hydroxy-3-[(4-sulfonato-1-naphthyl)diazenyl]naphthalene-1-sulfonate (3567-69-9)LD50 was considered to be >2000 mg/kg bw. All these studies concluded that the LD50 value is>2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, disodium [μ-[[7,7'-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl] azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-) cannot be classified for acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/210d9c6b-4489-4144-a162-857ee4a3e585/documents/417dc63e-339d-464a-a5c6-f4d26a9718f5_eecc017e-3e50-4e2e-a11e-2239046e1107.html,,,,,, "Disodium [μ-[[7,7'-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-)",6798-03-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/210d9c6b-4489-4144-a162-857ee4a3e585/documents/417dc63e-339d-464a-a5c6-f4d26a9718f5_eecc017e-3e50-4e2e-a11e-2239046e1107.html,,oral,LD50,"7,884 mg/kg bw",no adverse effect observed, "Disodium [μ-[[7,7'-iminobis[4-hydroxy-3-[[2-hydroxy-5-sulphamoylphenyl]azo]naphthalene-2-sulphonato]](6-)]]dicuprate(2-)",6798-03-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/210d9c6b-4489-4144-a162-857ee4a3e585/documents/417dc63e-339d-464a-a5c6-f4d26a9718f5_eecc017e-3e50-4e2e-a11e-2239046e1107.html,,dermal,LD50,"11,253 mg/kg bw",no adverse effect observed, "Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]",72828-69-4, The acute oral median lethal dose (LD50) of Acid Yellow 079 in rats is greater than 5000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b5321eb-5ba4-4b45-b290-86b7b0bfb385/documents/fd808d73-3bb5-4947-b2b4-dfbc44131488_3b7c13f1-dbbd-45c4-b362-2909c41f814b.html,,,,,, "Disodium 1,1'-isopropylidenedi-p-phenylene bis[2-[[5-amino-3-methyl-1-(3-sulphonatophenyl)-1H-pyrazol-5-yl]azo]benzenesulphonate]",72828-69-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b5321eb-5ba4-4b45-b290-86b7b0bfb385/documents/fd808d73-3bb5-4947-b2b4-dfbc44131488_3b7c13f1-dbbd-45c4-b362-2909c41f814b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Disodium 1,3,4-thiadiazole-2,5-dithiolate",55906-42-8,"Acute toxicity oral (Read-across from CAS 1072-71-5): OECD 401, Sherman-Wistar albino rats, male, LD50 = 930 mg/kg Acute toxicity oral: similar to 16 CFR - P.114, Sherman-Wistar albino rats, male, LD50 = 2955 mg/kg (active ingredient) Acute toxicity dermal (Read-across from CAS 1072-71-5): OECD 402, Wistar rats, female, LD50 >= 2000 mg/kg, LD0 >= 2000 mg/kg Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): acceptable for classification ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64fe4483-407f-40d2-b6c9-6f7a55c3b98c/documents/8108a0f2-1289-4aa3-b93f-50f5ccff631f_94c57ebf-8fcd-4294-b2eb-5886faa4de26.html,,,,,, "Disodium 1,3,4-thiadiazole-2,5-dithiolate",55906-42-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64fe4483-407f-40d2-b6c9-6f7a55c3b98c/documents/8108a0f2-1289-4aa3-b93f-50f5ccff631f_94c57ebf-8fcd-4294-b2eb-5886faa4de26.html,,oral,LD50,930 mg/kg bw,adverse effect observed, "Disodium 1,3,4-thiadiazole-2,5-dithiolate",55906-42-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64fe4483-407f-40d2-b6c9-6f7a55c3b98c/documents/8108a0f2-1289-4aa3-b93f-50f5ccff631f_94c57ebf-8fcd-4294-b2eb-5886faa4de26.html,,dermal,LD0,"> 2,000 mg/kg bw",no adverse effect observed, "Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",70209-99-3,"Based on the results obtained from an OECD Guideline 422 study conducted with a read-across substance, NOAEL (No Observed Adverse Effect Level) for males and females was established at 1000 mg/kg bw/day. Key study performed according to OECD Guideline 422 (study duration chronic) and in accordance with GLP. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26fc35be-faad-462a-b37b-3802755cc339/documents/0c131ae1-aa74-4b40-8aab-0ce136d16b28_ed1fc168-ffce-4dc2-bf79-29ed1ca2db8a.html,,,,,, "Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",70209-99-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26fc35be-faad-462a-b37b-3802755cc339/documents/0c131ae1-aa74-4b40-8aab-0ce136d16b28_ed1fc168-ffce-4dc2-bf79-29ed1ca2db8a.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",70209-99-3, The acute oral LD50 of FAT 40068/A in rats of both sexes observed over a period of 14 days is approximately 7700 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26fc35be-faad-462a-b37b-3802755cc339/documents/e850fd9c-7a2f-4363-a72e-8fd6e39acb7f_ed1fc168-ffce-4dc2-bf79-29ed1ca2db8a.html,,,,,, "Disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",70209-99-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26fc35be-faad-462a-b37b-3802755cc339/documents/e850fd9c-7a2f-4363-a72e-8fd6e39acb7f_ed1fc168-ffce-4dc2-bf79-29ed1ca2db8a.html,,oral,LD50,"7,700 mg/kg bw",adverse effect observed, "Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate",16102-99-1," The 29-day oral administration of Reactive Blue 19:1 at dose levels of 62.5, 250, and 1000 mg/kg body weight/day did not result in any test substance-related toxicity. Consequently, the ""no toxic effect level"" was considered to be 1000 mg/kg bw/day or above. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/189d5021-8e1e-49b6-9110-69372d4a3835/documents/3ca83a27-0e17-4c0c-94fe-6efe1492255f_f11630e7-b0cb-4354-84d0-64b23e1aa47b.html,,,,,, "Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate",16102-99-1," No mortality occured among male and female rats in an OECD 401 limit test. The LD50 (oral, rat) is > 2000 mg/kg bw. No mortality occured among male and female rats in an OECD 402 limit test. The LD50 (rat, dermal) is > 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/189d5021-8e1e-49b6-9110-69372d4a3835/documents/94afa5a3-d0a2-4565-8022-84025942a71d_f11630e7-b0cb-4354-84d0-64b23e1aa47b.html,,,,,, "Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate",16102-99-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/189d5021-8e1e-49b6-9110-69372d4a3835/documents/94afa5a3-d0a2-4565-8022-84025942a71d_f11630e7-b0cb-4354-84d0-64b23e1aa47b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]anthracene-2-sulphonate",16102-99-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/189d5021-8e1e-49b6-9110-69372d4a3835/documents/94afa5a3-d0a2-4565-8022-84025942a71d_f11630e7-b0cb-4354-84d0-64b23e1aa47b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 2-(11-oxido-3-oxo-3H-dibenzo[c,h]xanthen-7-yl)benzoate",6359-10-0, The study on acute oral toxicity does not need to be conducted as the substance is classified as corrosive to the skin. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b698ddff-bc92-458a-a46f-f02f3cedb2ae/documents/02a36039-f6ef-4bd7-8545-a9b6166cdc00_414b6589-3bb1-4817-a192-29e0e789ef63.html,,,,,, "Disodium 2-(2,3-dihydro-1,3-dioxosulphonato-1H-inden-2-yl)quinolinesulphonate",84924-83-4, NOAEL (repeated oral toxicity rat chronic study) = 250 mg/kg bw/ day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ba13c7f-f7a5-4a1e-8ef1-dfefe872272a/documents/e7acea1c-e2d8-443f-814a-e86186b930bb_ad45a20e-7d77-4e24-b666-7e20efe6942f.html,,,,,, "Disodium 2-(2,3-dihydro-1,3-dioxosulphonato-1H-inden-2-yl)quinolinesulphonate",84924-83-4, LD50 rat oral > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ba13c7f-f7a5-4a1e-8ef1-dfefe872272a/documents/a20a1784-8a27-44eb-99de-498baf2b7641_ad45a20e-7d77-4e24-b666-7e20efe6942f.html,,,,,, "Disodium 2,2'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[3-bromo-5-butyltoluene-4-sulphonate]",73398-29-5," Acute toxicity: oral. Driscoll (1993) Under the conditions of the study, the acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bodyweight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f6010b2-6d9b-4aed-bbe8-e2536b8190ba/documents/55a5448f-f304-4cb9-88d9-c59c8e509966_8308cb90-8b6b-4910-8946-be72a09d72b0.html,,,,,, "Disodium 2,5-dichloro-4-[4-[[5-[[(dodecyloxy)carbonyl]amino]-2-sulphonatophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonate",71873-51-3, Oral LD50 (male and female) > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af05f889-2f1e-4abd-a2db-da80d3fdf6ce/documents/9b15d408-5835-42dc-91ec-073b45f4595d_6deb5115-974a-4bbf-8ab2-8e9c8c69bc15.html,,,,,, "Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-[(2-chloro-5-sulphonatophenyl)amino]-6-fluoro-1,3,5-triazin-2-yl]amino]benzenesulphonate",75268-65-4, The acute oral median lethal dose (LD50) of test substance is >2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8bb2b06-227e-4c1f-b52a-06e6221312d5/documents/5ae0c5a7-fb2a-4107-bea8-63df67277550_fde50825-916e-4fd6-a234-7dfe176a6289.html,,,,,, "Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-[(2-chloro-5-sulphonatophenyl)amino]-6-fluoro-1,3,5-triazin-2-yl]amino]benzenesulphonate",75268-65-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8bb2b06-227e-4c1f-b52a-06e6221312d5/documents/5ae0c5a7-fb2a-4107-bea8-63df67277550_fde50825-916e-4fd6-a234-7dfe176a6289.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]benzenesulphonate",84000-63-5," The repeated dose toxicity study was predicted using OECD QSAR toolbox version 3.3 (2017) with log kow as the primary descriptor and considering the six closest read across substances; to evaluate the toxic effects of administration of disodium 2-[[5-carbamoyl-1 -ethyl-1,6 -dihydro-2-hydroxy-4- methyl-6- oxo- 3- pyridyl] azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl] phenyl]amino]-1,3,5-triazin-2-yl] amino]ben zenesulphonate(CAS No. 84000-63-5) in rats by the oral route in a 13 weeks of exposure. No adverse effects were observed. Therefore, the no-observed adverse effect level (NOAEL) of disodium 2-[[5-carbamoyl -1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl] azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]benzen esulphonate (CAS No. 84000-63-5) was estimated to be 629.28 mg/kg bw/day (nominal). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0ec3e92-efa2-4b83-88d3-a840c9e333f5/documents/9a015097-cf9e-46b9-8da7-7a1fb93ca010_fe51f8ff-befd-4b54-8aac-11557baeb8b0.html,,,,,, "Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]benzenesulphonate",84000-63-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0ec3e92-efa2-4b83-88d3-a840c9e333f5/documents/9a015097-cf9e-46b9-8da7-7a1fb93ca010_fe51f8ff-befd-4b54-8aac-11557baeb8b0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,629.28 mg/kg bw/day,,rat "Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]benzenesulphonate",84000-63-5," Acute toxicity: oral In a prediction done by SSS (2017) using the OECD QSAR toolbox with log kow as the primary descriptor, the acute oral toxicity was estimated for disodium 2-{2-[(3Z)-5-carbamoyl-1-ethyl- 4-methyl-2,6- dioxo-1,2,3,6-tetrahydropyridin-3-ylidene]hydrazin-1-yl}-4-{[4-chloro-6-({3-[2-(sulfonatooxy)ethanesulfonyl] phe nyl}amino)-1,3,5-triazin-2-yl]amino}benzene-1-sulfonate. The LD50 was estimated to be 3790 mg/kg bw when Wistar male and female rats were orally exposed with disodium 2-{2-[(3Z)-5-carbamoyl-1-ethyl-4-methyl-2,6- dioxo-1,2,3,6-tetrahydropyridin-3-ylidene]hydrazin-1-yl}-4- {[4-chloro-6-({3- [2-(sulfonatooxy)ethan esulfonyl]phenyl}amino)-1,3,5-triazin-2-yl]amino}benzene-1-sulfonate.   Acute toxicity: inhalation According to column 2 of REACH Annex VIII, the acute toxicity inhalation study need not be conducted because exposure of humans via inhalation route is not likely taking into account the particle size distribution of the substance the majority of the particles were found to be in the size of 106.0 micrometer which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical disodium 2-[[5-ca rbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl] azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl] sulphonyl] phenyl]amino] -1,3,5-tria zin-2-yl]a mino]benzenesulphonate is highly unlikely. Therefore this study is considered for waiver.   Acute toxicity: dermal The acute toxicity study was predicted using OECD QSAR toolbox version 3.3 (2017) with log kow as the primary descriptor; to evaluate the toxic effects of administration of disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl] azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl] sulphonyl] phenyl]amino]-1,3,5-triazin-2-yl]amino]benzenesulphonate (CAS No. 84000-63-5) in rabbits by the dermal route. 50% mortality was observed at 40760.10 mg/kg bw in treated rabbit.The acute dermal median lethal dose (LD50) of disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4- chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]benzenesulphonate in rabbit was estimated to be 40760.10 mg/kg bw. Thus, according to CLP criteria for acute toxicity rating for the chemicals, it infers that disodium 2-[[5-carbamoyl-1-ethyl-1,6- dihydro-2-hydroxy -4- methyl- 6-oxo-3 -pyridyl] azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]benzenesulphonate (CAS No. 84000- 63-5) does not classify as an acute dermal toxicant. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0ec3e92-efa2-4b83-88d3-a840c9e333f5/documents/2ab330b0-0072-4c05-b438-6a82a1095895_fe51f8ff-befd-4b54-8aac-11557baeb8b0.html,,,,,, "Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]benzenesulphonate",84000-63-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0ec3e92-efa2-4b83-88d3-a840c9e333f5/documents/2ab330b0-0072-4c05-b438-6a82a1095895_fe51f8ff-befd-4b54-8aac-11557baeb8b0.html,,oral,LD50,"3,790 mg/kg bw",no adverse effect observed, "Disodium 2-[[5-carbamoyl-1-ethyl-1,6-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridyl]azo]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]benzenesulphonate",84000-63-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0ec3e92-efa2-4b83-88d3-a840c9e333f5/documents/2ab330b0-0072-4c05-b438-6a82a1095895_fe51f8ff-befd-4b54-8aac-11557baeb8b0.html,,dermal,LD50,"40,760.1 mg/kg bw",no adverse effect observed, Disodium 2-[4-[[1-[[(2-methoxy-5-methyl-4-sulphonatophenyl)amino]carbonyl]-2-oxopropyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonate,72705-26-1, Acute oral toxicity The acute oral LD50 was determined to be > 2000 mg/kg bw. Acute dermal toxicity The acute dermal LD50 was determined to be > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b096ac3a-3d14-4962-b799-18778d72825f/documents/b6c6879f-59d8-454d-89da-02d8c40c8256_4ffc398d-d502-403f-bdea-27e02ef45823.html,,,,,, Disodium 2-[4-[[1-[[(2-methoxy-5-methyl-4-sulphonatophenyl)amino]carbonyl]-2-oxopropyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonate,72705-26-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b096ac3a-3d14-4962-b799-18778d72825f/documents/b6c6879f-59d8-454d-89da-02d8c40c8256_4ffc398d-d502-403f-bdea-27e02ef45823.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Disodium 2-[4-[[1-[[(2-methoxy-5-methyl-4-sulphonatophenyl)amino]carbonyl]-2-oxopropyl]azo]phenyl]-6-methylbenzothiazole-7-sulphonate,72705-26-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b096ac3a-3d14-4962-b799-18778d72825f/documents/b6c6879f-59d8-454d-89da-02d8c40c8256_4ffc398d-d502-403f-bdea-27e02ef45823.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Disodium 2-[4-[[2-cyano-3-[4-[methyl(2-sulphonatoethyl)amino]phenyl]-1-oxoallyl]amino]phenyl]-6-methylbenzothiazole-7-sulphonate,2498-95-5,The acute oral toxicity in rats of the test item was determined in an OECD guideline study. The LD50 was determined to be > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6e86a2e-777d-4bf3-a0c7-2ed11fcbfe80/documents/IUC5-cabe208f-d275-41e4-b2ae-a6f56ade4561_91f5f0b3-c866-4619-885e-a7de2919ab14.html,,,,,, Disodium 2-[4-[[2-cyano-3-[4-[methyl(2-sulphonatoethyl)amino]phenyl]-1-oxoallyl]amino]phenyl]-6-methylbenzothiazole-7-sulphonate,2498-95-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6e86a2e-777d-4bf3-a0c7-2ed11fcbfe80/documents/IUC5-cabe208f-d275-41e4-b2ae-a6f56ade4561_91f5f0b3-c866-4619-885e-a7de2919ab14.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Disodium 3-(5-chloro-2-hydroxyphenylazo)-4,5-dihydroxynaphthalene-2,7-disulphonate",1058-92-0," By oral route in rat, LD50 > 5000 mg/kg. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f8966ec-06ab-4798-8540-38744aabb1bc/documents/16f8635b-13cd-4d19-bfc9-07150bd8be46_bc4a06a6-11e0-4628-b2e9-c75c5730ad6d.html,,,,,, "Disodium 3,3'-[[6-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]bis[imino(3-methoxy-4,1-phenylene)azo]]bis[benzenesulphonate]",52238-69-4, The substance is not expect to causes damage to organs through prolonged or repeated exposure (NO(A)EL (28d) (rat males/females) ≥ 1000 mg/kg bw day) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea63ee43-1a0a-448f-beb2-fd0048021630/documents/b6e68aa9-8f2a-4b26-94b3-8d14ad4ccdb3_5e239b2e-b106-4516-9896-ba97e0dfb6aa.html,,,,,, "Disodium 3,3'-[[6-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]bis[imino(3-methoxy-4,1-phenylene)azo]]bis[benzenesulphonate]",52238-69-4, Not harmful/toxic if swallowed (oral LD50 (female) > 2000 mg/kg bw) Not harmful/toxic in contact with skin (dermal LD50 (male and female) > 2000 mg/kg bw) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea63ee43-1a0a-448f-beb2-fd0048021630/documents/86846570-2847-4d6d-a4d1-a510d41b1bac_5e239b2e-b106-4516-9896-ba97e0dfb6aa.html,,,,,, "Disodium 3,3'-[cyclohexylidenebis[(2-methyl-4,1-phenylene)azo]]bis(4,6-dihydroxynaphthalene-2-sulphonate)",6507-79-5,LD50(oral) = 4955 mg/kg b.w ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1aa0dfc-5097-4cf8-b990-922796eb43fb/documents/IUC5-7b057e09-d217-4653-8755-df184f8aa6ac_d80c77ee-2bec-453b-afd0-46149b956534.html,,,,,, "Disodium 3,3'-[sulphonylbis[p-phenyleneazo(5-imino-3-methyl-1H-pyrazole-4,1-diyl)]]bis(benzenesulphonate)",71033-19-7," Acute oral toxicity, LD50: > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd986120-a95d-4bed-94f7-1723b1da257b/documents/23596599-131b-4b85-acb5-bf3594dc446d_159a70fc-0e55-48a9-9600-8faef7e96509.html,,,,,, "Disodium 3,3'-[sulphonylbis[p-phenyleneazo(5-imino-3-methyl-1H-pyrazole-4,1-diyl)]]bis(benzenesulphonate)",71033-19-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd986120-a95d-4bed-94f7-1723b1da257b/documents/23596599-131b-4b85-acb5-bf3594dc446d_159a70fc-0e55-48a9-9600-8faef7e96509.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 3,3'-dithiobis[propanesulphonate]",27206-35-5,"Repeated Dose Toxicity Oral: Carcinogenicity study, oral: drinking water, 350 mg/kg bw/day, rat (Sprague-Dawley), male, 40/group, similar to OECD 451, RA from Mesna: NO(A)EL = 350 mg/kg bw/day, there were no signs of toxicity in the animals that received Mesna alone.Repeated Dose Toxicity Oral: 6 month study, oral: gavage, 500, 1000 and 2000 mg/kg bw, rat (BD II and BD IX), m/f, 10/group, RA from Mesna: NOAEL = 2000 mg/kg bw, tolerated without compound linked mortality or morbidity.Repeated Dose Toxicity Oral: Chronic toxicity study, oral: drinking water, 1000 mg/L drinking water ≙ 10 mg/kg, rat (DA, Lewis), m/f, 15/group, similar to OECD 452, RA from Mesna: NO(A)EL = 10 mg/kg, no effects on mortality, body weight, gross pathology, histology, nonneoplastic and neoplastic lesions compared to vehicle control.Repeated Dose Toxicity – other routes: 6 weeks, daily iv-application: 1000 mg/kg bw/day, rats (Sprague-Dawley), m/f, 10/group: NO(A)EL = 1000 mg/kg bw/day, tolerated without side effects.Repeated Dose Toxicity – other routes: 6 weeks, daily iv-application: 316 mg/kg bw/day, dogs (Beagle), m/f, 3/group: LOEL = 316 mg/kg bw/day, the only toxic effects were vomiting and diarrhoea. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f56e2f1-5b0d-4b4b-bca5-7bf1722f5dd0/documents/IUC5-1f5884f3-37a5-409e-8a9e-b741638760cd_00ed8d66-746d-4248-bb17-0fb9cb3c49a7.html,,,,,, "Disodium 3,3'-dithiobis[propanesulphonate]",27206-35-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f56e2f1-5b0d-4b4b-bca5-7bf1722f5dd0/documents/IUC5-1f5884f3-37a5-409e-8a9e-b741638760cd_00ed8d66-746d-4248-bb17-0fb9cb3c49a7.html,Chronic toxicity – systemic effects,oral,NOAEL,350 mg/kg bw/day,,rat "Disodium 3,3'-dithiobis[propanesulphonate]",27206-35-5,"Acute Toxicity Oral: Acute study oral (gavage), rat (Sprague-Dawley) m/f (OECD guideline 401, GLP): LD50(oral) > 2000 mg/kg / LD0(oral) ≥ 2000 mg/kgAcute Toxicity Oral: Acute study oral (gavage), rat (Wistar) m/f (OECD guideline 401, GLP), read-across from 1-Propanesulfonic acid, 3-mercapto-, monosodium salt: LD50(oral) = 3720 mg/kg / LD0(oral) ≥ 2500 mg/kgAcute Toxicity Dermal: Acute study dermal (occlusive), rat (Wistar) m/f (OECD guideline 402, GLP): LD50(dermal) > 2000 mg/kg / LD0(dermal) ≥ 2000 mg/kgAcute Toxicity Dermal: Acute study dermal (occlusive), rat (Wistar) m/f (OECD guideline 402, GLP), read-across from 1-Propanesulfonic acid, 3-mercapto-, monosodium salt: LD50(dermal) > 7500 mg/kg / LD0(dermal) ≥ 7500 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f56e2f1-5b0d-4b4b-bca5-7bf1722f5dd0/documents/IUC5-8c806f3c-9654-440d-8b55-d57589e03cda_00ed8d66-746d-4248-bb17-0fb9cb3c49a7.html,,,,,, "Disodium 3-[(5-chloro-2-phenoxyphenyl)azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate",6416-66-6,"LD50, oral, rat, 14 days: > 5000 mg/LLD50, inhalation: not availableLD50, dermal: not available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43550378-6dcd-4a51-93e5-be66de3556be/documents/IUC5-37afb8d9-96a2-4844-b12e-11a077eb960a_bcc0ac00-4182-4113-8100-1800e77cfe2f.html,,,,,, "Disodium 3-[(5-chloro-2-phenoxyphenyl)azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate",6416-66-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43550378-6dcd-4a51-93e5-be66de3556be/documents/IUC5-37afb8d9-96a2-4844-b12e-11a077eb960a_bcc0ac00-4182-4113-8100-1800e77cfe2f.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Disodium 3-[[2,2'-dimethyl-4'-[[4-[[(p-tolyl)sulphonyl]oxy]phenyl]azo][1,1'-biphenyl]-4-yl]azo]-4-hydroxynaphthalene-2,7-disulphonate",6358-57-2, LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b60146a-22a2-4a45-9a79-69f013774064/documents/be6e6090-5a92-47de-bea2-7a3fd795fe77_93655758-b555-4f62-9af0-bd7a969a1a60.html,,,,,, "Disodium 3-[[2,4-bis(2-methylphenoxy)phenyl]azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate",70210-05-8,LD50 oral acute rat > 5000 mg/Kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/971d4368-b071-414a-b7f0-70e1f94c8962/documents/IUC5-807391a4-a9c5-48e1-8058-f64ec054be7a_fac8501d-8724-4137-86a9-77374436f8de.html,,,,,, "Disodium 3-[[2,4-bis(2-methylphenoxy)phenyl]azo]-4-hydroxy-5-[[(p-tolyl)sulphonyl]amino]naphthalene-2,7-disulphonate",70210-05-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/971d4368-b071-414a-b7f0-70e1f94c8962/documents/IUC5-807391a4-a9c5-48e1-8058-f64ec054be7a_fac8501d-8724-4137-86a9-77374436f8de.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Disodium 3-[[4-amino-9,10-dihydro-9,10-dioxo-3-[sulphonato-4-(1,1,3,3-tetramethylbutyl)phenoxy]-1-anthryl]amino]-2,4,6-trimethylbenzenesulphonate",72243-90-4, Oral LD50 (male and female) > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a4cf6e0-149b-4903-b576-4fb0cf68d5e4/documents/089fcf45-8e60-40d0-ba95-3344f1d44f8d_3e3a6349-0b3c-466e-9187-0c0de6f5375b.html,,,,,, "Disodium 3-[[4-amino-9,10-dihydro-9,10-dioxo-3-[sulphonato-4-(1,1,3,3-tetramethylbutyl)phenoxy]-1-anthryl]amino]-2,4,6-trimethylbenzenesulphonate",72243-90-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a4cf6e0-149b-4903-b576-4fb0cf68d5e4/documents/089fcf45-8e60-40d0-ba95-3344f1d44f8d_3e3a6349-0b3c-466e-9187-0c0de6f5375b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Disodium 3-[[ethyl[4-[[4-[(3-sulphonatophenyl)azo]-1-naphthyl]azo]phenyl]amino]methyl]benzenesulphonate,70210-06-9," Acute oral toxicity, LD50: > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d17557ad-68bc-4a4c-ba93-655b5282702d/documents/e321964f-dcd8-4774-927f-34fa6cb7f0eb_932b9a52-cfd9-46dc-8abb-02b659a4d66c.html,,,,,, Disodium 3-[[ethyl[4-[[4-[(3-sulphonatophenyl)azo]-1-naphthyl]azo]phenyl]amino]methyl]benzenesulphonate,70210-06-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d17557ad-68bc-4a4c-ba93-655b5282702d/documents/e321964f-dcd8-4774-927f-34fa6cb7f0eb_932b9a52-cfd9-46dc-8abb-02b659a4d66c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate",4553-89-3," Repeated dose toxicity: oral The NOAEL for Chocolate Brown HT (Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate ) in male/ female Wistar rats was determined to be 500 mg/Kg/day. Repeated dose toxicity: inhalation In accordance with column 2 of Annex VIII of the REACH regulation, testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance. This chemical ha a very low vapour pressure of 1.48E-33 Pascal at 25°C and thus exposure by the inhlation route for this chemical is unlikely. Repeated dose toxicity: dermal The chemical disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate (synonym Brown HT) is widely used as a food color and thus the most likely route of repeated exposure is expected to be through the oral route and not the dermal route. Hence this end point was considered for waiver. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3280191d-b343-4ad5-b5e1-c18172838e54/documents/IUC5-c0c9d702-6dfa-42ba-b041-36efcd667349_5650fd69-0d4f-4a59-a88d-46099309bb10.html,,,,,, "Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate",4553-89-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3280191d-b343-4ad5-b5e1-c18172838e54/documents/IUC5-c0c9d702-6dfa-42ba-b041-36efcd667349_5650fd69-0d4f-4a59-a88d-46099309bb10.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate",4553-89-3," Acute toxicity: oral The median lethal dose (LD50) for the substance Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate is determined to be > 2000 mg/Kg in female Evans albino mice. Acute toxicity: inhalation In accordance with column 2 of Annex VIII of the REACH regulation, testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance. This chemical has a very low vapour pressure of 1.48E-33 Pascal at 25°C and thus exposure by the inhalation route for this chemical is unlikely. Acute toxicity: dermal The median lethal dose (LD50) for the substance Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate is estimated to be 35636.23 mg/Kg in rabbits via dermal route. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3280191d-b343-4ad5-b5e1-c18172838e54/documents/IUC5-170b481a-0362-40d9-8875-de4ecf35399f_5650fd69-0d4f-4a59-a88d-46099309bb10.html,,,,,, "Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate",4553-89-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3280191d-b343-4ad5-b5e1-c18172838e54/documents/IUC5-170b481a-0362-40d9-8875-de4ecf35399f_5650fd69-0d4f-4a59-a88d-46099309bb10.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 4,4'-[[2,4-dihydroxy-5-(hydroxymethyl)-1,3-phenylene]bis(azo)]bisnaphthalene-1-sulphonate",4553-89-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3280191d-b343-4ad5-b5e1-c18172838e54/documents/IUC5-170b481a-0362-40d9-8875-de4ecf35399f_5650fd69-0d4f-4a59-a88d-46099309bb10.html,,dermal,LD50,"35,636.23 mg/kg bw",no adverse effect observed, "Disodium 4,4'-bis(5-hydroxy-3-methyl-1-phenyl-1H-pyrazol-4-ylazo)-1,1'-biphenyl-2,6'-disulphonate",6375-55-9, Acute Oral Toxicity LD50 = 2387 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27b9e4d0-5255-42eb-a397-418b93c889f9/documents/cb0f6681-ab0c-4171-a353-98e514b41f48_18f0f395-7473-4fa2-8e5b-bf7b9fdd4f2c.html,,,,,, "Disodium 4,4'-bis(5-hydroxy-3-methyl-1-phenyl-1H-pyrazol-4-ylazo)-1,1'-biphenyl-2,6'-disulphonate",6375-55-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27b9e4d0-5255-42eb-a397-418b93c889f9/documents/cb0f6681-ab0c-4171-a353-98e514b41f48_18f0f395-7473-4fa2-8e5b-bf7b9fdd4f2c.html,,oral,LD50,"2,387 mg/kg bw",no adverse effect observed, "Disodium 4,4'-bis[(4-anilino-6-methoxy-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate",3426-43-5, LD20 = 3300 mg/kg bw LD50 > 3300 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/213a462b-4327-40cb-8e5f-9014911420f3/documents/85ccd8c0-0bf8-48a3-a0fe-385eea67966c_ca872ad2-a3e5-4fbd-9bcb-4c46fb01e76f.html,,,,,, "Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate",16090-02-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c135e00-32c7-4784-820d-23cbe20eb0c0/documents/03aa74d6-7f66-45c8-a086-8a21d2e647b4_809361e2-3c28-41c0-81e5-3aa32cfc6fc2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate",16090-02-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The quality of the database is high, since a number of studies are available of good quality and consistent results. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c135e00-32c7-4784-820d-23cbe20eb0c0/documents/IUC5-c4bdd949-d49b-4887-9f49-6e9bea01bb42_809361e2-3c28-41c0-81e5-3aa32cfc6fc2.html,,,,,, "Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate",16090-02-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c135e00-32c7-4784-820d-23cbe20eb0c0/documents/IUC5-c4bdd949-d49b-4887-9f49-6e9bea01bb42_809361e2-3c28-41c0-81e5-3aa32cfc6fc2.html,,oral,LD50,"7,562 mg/kg bw",no adverse effect observed, "Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate",16090-02-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c135e00-32c7-4784-820d-23cbe20eb0c0/documents/IUC5-c4bdd949-d49b-4887-9f49-6e9bea01bb42_809361e2-3c28-41c0-81e5-3aa32cfc6fc2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 4,4'-bis[(4-anilino-6-morpholino-1,3,5-triazin-2-yl)amino]stilbene-2,2'-disulphonate",16090-02-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c135e00-32c7-4784-820d-23cbe20eb0c0/documents/IUC5-c4bdd949-d49b-4887-9f49-6e9bea01bb42_809361e2-3c28-41c0-81e5-3aa32cfc6fc2.html,,inhalation,LC50,"1,895 mg/m3",no adverse effect observed, "Disodium 4,4'-bis[[4-anilino-6-[(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",17958-73-5,Rat oral LD50 > 5000 mg/kg bw   ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/237578c8-04ea-4d42-9ea8-d773362b7b13/documents/e26940fd-67f4-4cf4-9730-0c893cdc3204_36d646cd-6aab-48b5-96ba-e5b9c67876f6.html,,,,,, "Disodium 4,4'-bis[[4-anilino-6-[(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",17958-73-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/237578c8-04ea-4d42-9ea8-d773362b7b13/documents/e26940fd-67f4-4cf4-9730-0c893cdc3204_36d646cd-6aab-48b5-96ba-e5b9c67876f6.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",13863-31-5, NOAEL in male rats ≥ 250 mg/kg bw/day (based on the OECD 422 study on OB 3b-A) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1811604-ced7-4804-be85-7d405e7e6c6e/documents/f461314c-0c8a-4028-8b92-e960b076eaa5_b56a7a47-baf2-4eb3-8266-e143f8464dac.html,,,,,, "Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",13863-31-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1811604-ced7-4804-be85-7d405e7e6c6e/documents/f461314c-0c8a-4028-8b92-e960b076eaa5_b56a7a47-baf2-4eb3-8266-e143f8464dac.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",13863-31-5, Rat oral LD50 > 10000 mg/kg bw Rat inhalation LC50 > 1895 mg/m3 Rat dermal LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1811604-ced7-4804-be85-7d405e7e6c6e/documents/IUC5-50fc9f68-3e0c-4d5d-ae14-91535d30df70_b56a7a47-baf2-4eb3-8266-e143f8464dac.html,,,,,, "Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",13863-31-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1811604-ced7-4804-be85-7d405e7e6c6e/documents/IUC5-50fc9f68-3e0c-4d5d-ae14-91535d30df70_b56a7a47-baf2-4eb3-8266-e143f8464dac.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",13863-31-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1811604-ced7-4804-be85-7d405e7e6c6e/documents/IUC5-50fc9f68-3e0c-4d5d-ae14-91535d30df70_b56a7a47-baf2-4eb3-8266-e143f8464dac.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 4,4'-bis[[6-anilino-4-[(2-hydroxyethyl)methylamino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",13863-31-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1811604-ced7-4804-be85-7d405e7e6c6e/documents/IUC5-50fc9f68-3e0c-4d5d-ae14-91535d30df70_b56a7a47-baf2-4eb3-8266-e143f8464dac.html,,inhalation,LC50,"1,895 mg/m3",no adverse effect observed, "Disodium 4,4'-bis[6-anilino-[4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",4193-55-9, NOAEL in male rats ≥ 250 mg/kg bw/day (based on the sub-acute study on OB 3b-A) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79496aa8-034f-4a13-91c7-f35faeee28b1/documents/a060dea8-58fe-459c-9647-c5effe6dc220_5be3fd74-f3c7-4cc3-9a4d-7521d73ccc06.html,,,,,, "Disodium 4,4'-bis[6-anilino-[4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",4193-55-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79496aa8-034f-4a13-91c7-f35faeee28b1/documents/a060dea8-58fe-459c-9647-c5effe6dc220_5be3fd74-f3c7-4cc3-9a4d-7521d73ccc06.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Disodium 4,4'-bis[6-anilino-[4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",4193-55-9,Rat oral LD50 > 5000 mg/kg bwRat inhalation LC50 > 1895 mg/m3Rat dermal LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79496aa8-034f-4a13-91c7-f35faeee28b1/documents/IUC5-c3dc7747-2f3a-4248-9b13-6b2c56a66a3c_5be3fd74-f3c7-4cc3-9a4d-7521d73ccc06.html,,,,,, "Disodium 4,4'-bis[6-anilino-[4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",4193-55-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79496aa8-034f-4a13-91c7-f35faeee28b1/documents/IUC5-c3dc7747-2f3a-4248-9b13-6b2c56a66a3c_5be3fd74-f3c7-4cc3-9a4d-7521d73ccc06.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Disodium 4,4'-bis[6-anilino-[4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",4193-55-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79496aa8-034f-4a13-91c7-f35faeee28b1/documents/IUC5-c3dc7747-2f3a-4248-9b13-6b2c56a66a3c_5be3fd74-f3c7-4cc3-9a4d-7521d73ccc06.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate",65212-76-2,"A subacute toxicity study on rats (OECD 407, GLP) was performed to evaluate the repeated dose toxicity of the substance. The test item did not induce any mortalities, abnormalities or clinical symptoms. Based on the results of these studies, the NOEL and the NOAEL of the test substance is 1462.9 for male and 1552.1 mg/kg bw /d for female rats. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/027d7378-afb3-4de5-be87-cf755ce0b181/documents/IUC5-a4941e59-6c3f-40a0-b6d5-8e1d20768c34_57535427-72c6-4ccf-9e1b-0296c9793e9b.html,,,,,, "Disodium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate",65212-76-2,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/027d7378-afb3-4de5-be87-cf755ce0b181/documents/IUC5-a4941e59-6c3f-40a0-b6d5-8e1d20768c34_57535427-72c6-4ccf-9e1b-0296c9793e9b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,462.9 mg/kg bw/day",,rat "Disodium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate",65212-76-2,"Studies on acute oral, dermal or inhalative toxicity of the test item (di-sodium salt) were not performed. Therefore, information on acute toxicity is derived from experimental data of an analogue substance (calcium salt). Three studies were performed to evaluate acute oral, dermal and inhalative toxicity of the test substance to the rat (according OECD 401, 402, 403). The test substance did not induce any mortalities, abnormalities or clinical signs when applied oral or dermal. Also single administration via respiratory system did not cause health effects or mortalities. The LD50 for oral and dermal toxicity is considered to be 2000 mg/kg bw, LC50 is > 5.5 mg/l air. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/027d7378-afb3-4de5-be87-cf755ce0b181/documents/IUC5-e259bb15-e612-4b53-9590-db989c45019e_57535427-72c6-4ccf-9e1b-0296c9793e9b.html,,,,,, "Disodium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate",65212-76-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/027d7378-afb3-4de5-be87-cf755ce0b181/documents/IUC5-e259bb15-e612-4b53-9590-db989c45019e_57535427-72c6-4ccf-9e1b-0296c9793e9b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Disodium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate",65212-76-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/027d7378-afb3-4de5-be87-cf755ce0b181/documents/IUC5-e259bb15-e612-4b53-9590-db989c45019e_57535427-72c6-4ccf-9e1b-0296c9793e9b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 4,5-dichloro-2-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphonatophenyl)-1H-pyrazol-4-yl]azo]benzenesulphonate",65212-76-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/027d7378-afb3-4de5-be87-cf755ce0b181/documents/IUC5-e259bb15-e612-4b53-9590-db989c45019e_57535427-72c6-4ccf-9e1b-0296c9793e9b.html,,inhalation,LC50,5.5 mg/m3,no adverse effect observed, "Disodium 4-[(2-amino-4-hydroxyphenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate, mono[(p-nitrophenyl)azo] mono[(2-hydroxy-3,5-dinitrophenyl)azo] derivative",84522-43-0," LD50 (oral, rat) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31c32ced-7805-44c9-b99d-d859a8b7e36a/documents/c6a650e4-456d-450b-bed9-dfbeb16a95c2_6b7d8592-670f-4dfa-81f8-02b3239f4281.html,,,,,, "Disodium 4-[(2-amino-4-hydroxyphenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate, mono[(p-nitrophenyl)azo] mono[(2-hydroxy-3,5-dinitrophenyl)azo] derivative",84522-43-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31c32ced-7805-44c9-b99d-d859a8b7e36a/documents/c6a650e4-456d-450b-bed9-dfbeb16a95c2_6b7d8592-670f-4dfa-81f8-02b3239f4281.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 4-[4-[[5-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulphonate",70247-70-0,"Based on the study performed with FAT 40061/F, according to OECD Guideline 422, a NOAEL (No Observed Adverse Effect Level) for males and females was established at 1000 mg/kg bw/day.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3948163-0413-4dc9-828e-f0e0ebd8efb6/documents/IUC5-f9c447bf-4fc2-4bf5-88e4-1ab94777eac2_f875c834-ab41-4dec-9cd1-9e75ac304509.html,,,,,, "Disodium 4-[4-[[5-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulphonate",70247-70-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3948163-0413-4dc9-828e-f0e0ebd8efb6/documents/IUC5-f9c447bf-4fc2-4bf5-88e4-1ab94777eac2_f875c834-ab41-4dec-9cd1-9e75ac304509.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Disodium 4-[4-[[5-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulphonate",70247-70-0,The acute oral LD50 for FAT 40061/A was found to be >7750 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3948163-0413-4dc9-828e-f0e0ebd8efb6/documents/IUC5-4eaf9ac4-3d26-4be3-b8ef-9c3561b6f9c6_f875c834-ab41-4dec-9cd1-9e75ac304509.html,,,,,, "Disodium 4-[4-[[5-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]-2,5-dichlorobenzenesulphonate",70247-70-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3948163-0413-4dc9-828e-f0e0ebd8efb6/documents/IUC5-4eaf9ac4-3d26-4be3-b8ef-9c3561b6f9c6_f875c834-ab41-4dec-9cd1-9e75ac304509.html,,oral,LD50,"7,750 mg/kg bw",no adverse effect observed, "Disodium 4-amino-3,6-bis[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxynaphthalene-2,7-disulphonate",6428-31-5, The value of NOAEL for Repeated dose toxicity is 80 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4446d2e-f0db-4528-be4c-c27304d27171/documents/IUC5-759f4442-d30d-47d4-a596-a748119238d0_82c3e298-135e-4eec-9c15-8ba179ad2511.html,,,,,, "Disodium 4-amino-3,6-bis[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxynaphthalene-2,7-disulphonate",6428-31-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4446d2e-f0db-4528-be4c-c27304d27171/documents/IUC5-759f4442-d30d-47d4-a596-a748119238d0_82c3e298-135e-4eec-9c15-8ba179ad2511.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat "Disodium 4-amino-3,6-bis[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxynaphthalene-2,7-disulphonate",6428-31-5, NOAEL oral rat > 2000 mg/kg NOAEL inhalation rat > 5000 mg/m3 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4446d2e-f0db-4528-be4c-c27304d27171/documents/IUC5-9f43acf3-89e2-43fa-b94f-70f62ea24478_82c3e298-135e-4eec-9c15-8ba179ad2511.html,,,,,, "Disodium 4-amino-3,6-bis[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxynaphthalene-2,7-disulphonate",6428-31-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4446d2e-f0db-4528-be4c-c27304d27171/documents/IUC5-9f43acf3-89e2-43fa-b94f-70f62ea24478_82c3e298-135e-4eec-9c15-8ba179ad2511.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 4-amino-3,6-bis[[4-[(2,4-diaminophenyl)azo]phenyl]azo]-5-hydroxynaphthalene-2,7-disulphonate",6428-31-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4446d2e-f0db-4528-be4c-c27304d27171/documents/IUC5-9f43acf3-89e2-43fa-b94f-70f62ea24478_82c3e298-135e-4eec-9c15-8ba179ad2511.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "disodium 4-amino-6-[[4-(N-(4-((E)-(2,4-diaminophenyl)diazenyl)phenyl)sulfamoyl)phenyl)diazenyl)-5-hydroxy-3-((E)-(4-nitrophenyl)diazenyl)naphthalene-2,7-disulfonate",201792-73-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7563f011-9205-42d4-b42c-b8b0e29312a2/documents/IUC5-2043e3d3-111c-450c-8e0a-3b87ac411004_7bd6ff7c-5e51-4558-80e7-3d989fd4e1da.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "disodium 4-amino-6-[[4-(N-(4-((E)-(2,4-diaminophenyl)diazenyl)phenyl)sulfamoyl)phenyl)diazenyl)-5-hydroxy-3-((E)-(4-nitrophenyl)diazenyl)naphthalene-2,7-disulfonate",201792-73-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7563f011-9205-42d4-b42c-b8b0e29312a2/documents/IUC5-2043e3d3-111c-450c-8e0a-3b87ac411004_7bd6ff7c-5e51-4558-80e7-3d989fd4e1da.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,40 mg/kg bw/day,,rat "disodium 4-amino-6-[[4-(N-(4-((E)-(2,4-diaminophenyl)diazenyl)phenyl)sulfamoyl)phenyl)diazenyl)-5-hydroxy-3-((E)-(4-nitrophenyl)diazenyl)naphthalene-2,7-disulfonate",201792-73-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7563f011-9205-42d4-b42c-b8b0e29312a2/documents/IUC5-31567421-7fea-40c0-872b-e6c7ee58e3d2_7bd6ff7c-5e51-4558-80e7-3d989fd4e1da.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "disodium 4-amino-6-[[4-(N-(4-((E)-(2,4-diaminophenyl)diazenyl)phenyl)sulfamoyl)phenyl)diazenyl)-5-hydroxy-3-((E)-(4-nitrophenyl)diazenyl)naphthalene-2,7-disulfonate",201792-73-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7563f011-9205-42d4-b42c-b8b0e29312a2/documents/IUC5-31567421-7fea-40c0-872b-e6c7ee58e3d2_7bd6ff7c-5e51-4558-80e7-3d989fd4e1da.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 4-hydroxynaphthalene-2,7-disulphonate",20349-39-7," Acute Oral Toxicity: The LD50 was estimated to be 2396.14 mg/kg bw,when female Wistar rats were orally exposed with Disodium 4-hydroxynaphthalene-2,7-disulphonate (20349-39-7) via gavage. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe0a91cd-876a-47b1-b15e-c1de3a723761/documents/3703db40-0f38-4d02-81bf-a2cf137d9661_3672015b-7c94-44d2-8236-7742f8fca454.html,,,,,, "Disodium 4-hydroxynaphthalene-2,7-disulphonate",20349-39-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe0a91cd-876a-47b1-b15e-c1de3a723761/documents/3703db40-0f38-4d02-81bf-a2cf137d9661_3672015b-7c94-44d2-8236-7742f8fca454.html,,oral,LD50,"2,396.14 mg/kg bw",no adverse effect observed, "Disodium 5-(benzoylamino)-4-hydroxy-3-[[2-(2-methylphenoxy)phenyl]azo]naphthalene-2,7-disulphonate",70210-37-6, oral LD50 in rats > 15000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcaf833d-f49c-4c8b-b195-0bae4a2dea39/documents/IUC5-e660366e-d39a-4a82-a976-aaaba874528d_a774d800-3954-4e3b-9d07-8bc37be172bf.html,,,,,, "Disodium 5-(benzoylamino)-4-hydroxy-3-[[2-(2-methylphenoxy)phenyl]azo]naphthalene-2,7-disulphonate",70210-37-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcaf833d-f49c-4c8b-b195-0bae4a2dea39/documents/IUC5-e660366e-d39a-4a82-a976-aaaba874528d_a774d800-3954-4e3b-9d07-8bc37be172bf.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "Disodium 5,5'-[(1-methylethylidene)bis(4,1-phenyleneoxysulphonyl-2,1-phenyleneazo)]bis[6-amino-4-hydroxynaphthalene-2-sulphonate]",52333-30-9,The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82dc24ee-9c1e-4eba-be61-53bfd906aef7/documents/ddecbf20-2d4f-4661-94c3-f4616b3a2cb8_5c4ea5cd-66ba-4b58-bad3-5949f99e8a96.html,,,,,, "Disodium 5,5'-[(1-methylethylidene)bis(4,1-phenyleneoxysulphonyl-2,1-phenyleneazo)]bis[6-amino-4-hydroxynaphthalene-2-sulphonate]",52333-30-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82dc24ee-9c1e-4eba-be61-53bfd906aef7/documents/ddecbf20-2d4f-4661-94c3-f4616b3a2cb8_5c4ea5cd-66ba-4b58-bad3-5949f99e8a96.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 5,5'-[(1-methylethylidene)bis(4,1-phenyleneoxysulphonyl-2,1-phenyleneazo)]bis[6-aminonaphthalene-1-sulphonate]",70161-18-1," The acute median lethal oral dose (LD50) to rats of Acid Orange 94 Refined was determined according to the OECD Guideline for Testing of Chemicals No.420 ‘Acute Oral Toxicity – Fixed and EEC Methods for the determination of toxicity and other health effects. Commission Regulation No. 440/2008, Part B, Method B.1 bis. Acute Oral Toxicity: Fixed Dose Procedure. 30 May 2008. Dose Method’ Adopted 17 December 2001, according to GLP. ‘The melting point was determined using differential scanning calorimetry according to the OECD 102 guideline in accordance with GLP. The test item was determined to decompose from approximately 176 °C (449 K). As the test item decomposed, no value for melting point could be determined.’ The fixed dose method is a stepwise procedure that uses sighting investigations of one animal of a single sex per step followed by a main study of a further four animals. Depending on the mortality and/or the moribund status of the animals, on average two sighting steps and one or two main study steps may be necessary to allow a judgment on the acute toxicity of the test item. The acute median lethal oral dose (LD50) to rats of Acid Orange 94 Refined was demonstrated to be greater than 2000 mg/kg body weight. According to the Globally Harmonised System (GHS), described in Annex 2, Acid Orange 94 Refined does not meet the criteria for classification. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c0f16ea-8e0c-4fa8-884c-a094db3ccc73/documents/046baafe-5fb6-495f-a40b-9d182a14ef25_9854976d-5b64-41d4-b52e-81bb1182d01d.html,,,,,, "Disodium 5,5'-[(1-methylethylidene)bis(4,1-phenyleneoxysulphonyl-2,1-phenyleneazo)]bis[6-aminonaphthalene-1-sulphonate]",70161-18-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c0f16ea-8e0c-4fa8-884c-a094db3ccc73/documents/046baafe-5fb6-495f-a40b-9d182a14ef25_9854976d-5b64-41d4-b52e-81bb1182d01d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 5-[[2,4-dihydroxy-5-[(4-nitrophenyl)azo]phenyl]azo]-4-hydroxy-3-[(2-hydroxy-3,5-dinitrophenyl)azo]naphthalene-2,7-disulphonate",68155-63-5," LD50 (oral, rat) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9e4214f-8d82-4456-bc05-d425299842ac/documents/3121c11c-c925-406f-8299-d4c32f3e0e00_9b78e69d-aec0-4f9b-8bb3-cc146f00ae20.html,,,,,, "Disodium 5-[[2,4-dihydroxy-5-[(4-nitrophenyl)azo]phenyl]azo]-4-hydroxy-3-[(2-hydroxy-3,5-dinitrophenyl)azo]naphthalene-2,7-disulphonate",68155-63-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9e4214f-8d82-4456-bc05-d425299842ac/documents/3121c11c-c925-406f-8299-d4c32f3e0e00_9b78e69d-aec0-4f9b-8bb3-cc146f00ae20.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Disodium 5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxy-6-(methylamino)naphthalene-2-sulphonate,70210-39-8,The acute oral median lethal dose (LD50) of Reactive Red 66 in rats of both sexes is greater than 7750 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eaf6c159-7596-46e7-b0a2-4b29ccdfbb80/documents/IUC5-693ce077-1a7a-4308-afcd-cf2879b8e616_f59bd637-cf97-4324-8652-a56836c4f9e6.html,,,,,, Disodium 5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxy-6-(methylamino)naphthalene-2-sulphonate,70210-39-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eaf6c159-7596-46e7-b0a2-4b29ccdfbb80/documents/IUC5-693ce077-1a7a-4308-afcd-cf2879b8e616_f59bd637-cf97-4324-8652-a56836c4f9e6.html,,oral,LD50,"7,750 mg/kg bw",no adverse effect observed, "Disodium 6-(4,6-dichloro-1,3,5-triazin-2-ylamino)-1-hydroxy-2-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-3-sulfonate",129009-88-7,The NOEL and NOAEL of the test substance were determined to be 1000 mg/kg bw/d or above . ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c93ac78c-5ae3-47ff-a215-a2c48e2e1001/documents/IUC5-fff594c8-282c-4479-ab26-4c4f3c0b2da8_c23da251-7669-4d1b-85a4-c97738a98dcb.html,,,,,, "Disodium 6-(4,6-dichloro-1,3,5-triazin-2-ylamino)-1-hydroxy-2-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-3-sulfonate",129009-88-7,The available data for test substance indicates a low potential for acute oral (LD50 >2000 mg/kg bw) and dermal toxicity (LD50 >2000 mg/kg bw). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c93ac78c-5ae3-47ff-a215-a2c48e2e1001/documents/IUC5-a9da7f19-df0f-459c-b3f1-c67b535d6c4f_c23da251-7669-4d1b-85a4-c97738a98dcb.html,,,,,, "Disodium 6-(4,6-dichloro-1,3,5-triazin-2-ylamino)-1-hydroxy-2-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-3-sulfonate",129009-88-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c93ac78c-5ae3-47ff-a215-a2c48e2e1001/documents/IUC5-a9da7f19-df0f-459c-b3f1-c67b535d6c4f_c23da251-7669-4d1b-85a4-c97738a98dcb.html,,oral,LD0,"2,000 mg/kg bw",no adverse effect observed, "Disodium 6-(4,6-dichloro-1,3,5-triazin-2-ylamino)-1-hydroxy-2-(4-(2-(sulfonatooxy)ethylsulfonyl)phenylazo)naphthalene-3-sulfonate",129009-88-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c93ac78c-5ae3-47ff-a215-a2c48e2e1001/documents/IUC5-a9da7f19-df0f-459c-b3f1-c67b535d6c4f_c23da251-7669-4d1b-85a4-c97738a98dcb.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, Disodium 6-amino-5-[[4-[(2-bromo-1-oxoallyl)amino]-2-[(4-methyl-3-sulphonatophenyl)sulphonyl]phenyl]azo]naphthalene-2-sulphonate,85187-33-3," The test substance is not toxic in an acute oral, inhalation and dermal toxicity studies. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/482a1ac4-e7bd-41d7-99b4-1e920d3efae0/documents/58684251-b3eb-4120-b673-e891ae8f5018_298ae326-7e62-4db2-866e-5f67ac635931.html,,,,,, Disodium 6-amino-5-[[4-[(2-bromo-1-oxoallyl)amino]-2-[(4-methyl-3-sulphonatophenyl)sulphonyl]phenyl]azo]naphthalene-2-sulphonate,85187-33-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/482a1ac4-e7bd-41d7-99b4-1e920d3efae0/documents/58684251-b3eb-4120-b673-e891ae8f5018_298ae326-7e62-4db2-866e-5f67ac635931.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Disodium 6-amino-5-[[4-[(2-bromo-1-oxoallyl)amino]-2-[(4-methyl-3-sulphonatophenyl)sulphonyl]phenyl]azo]naphthalene-2-sulphonate,85187-33-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/482a1ac4-e7bd-41d7-99b4-1e920d3efae0/documents/58684251-b3eb-4120-b673-e891ae8f5018_298ae326-7e62-4db2-866e-5f67ac635931.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, Disodium 6-amino-5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxynaphthalene-2-sulphonate,70210-40-1,The acute oral median lethal dose (LD50) of Reactive Red 065 in rats of both sexes was >7750 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29e385ff-1dca-4cdf-8cec-d8ee587ecdf2/documents/IUC5-db4cf37f-9fae-46e9-bec8-a7783a999a2c_1e22003f-8e8a-4466-908d-8c1886c371d2.html,,,,,, Disodium 6-amino-5-[[4-[(2-bromo-1-oxoallyl)amino]-2-sulphonatophenyl]azo]-4-hydroxynaphthalene-2-sulphonate,70210-40-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29e385ff-1dca-4cdf-8cec-d8ee587ecdf2/documents/IUC5-db4cf37f-9fae-46e9-bec8-a7783a999a2c_1e22003f-8e8a-4466-908d-8c1886c371d2.html,,oral,LD50,"7,750 mg/kg bw",no adverse effect observed, Disodium 6-hydroxy-5-[[4-[[4-(phenylamino)-3-sulphonatophenyl]azo]naphthyl]azo]naphthalene-2-sulphonate,6262-07-3," The test substance, Acid Black 26, was tested for reproduction and subacute toxicity using the OECD Test Guideline No. 422: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, Adopted by the Council on 28th July 2015. The value of NOAEL for repeated dose toxicity was established as 500 mg/kg body weight/day both for males and females. The value of NOAEL was determined on the basis of increased intensity of chronic progressive nephropathy in kidneys in both sexes (dose dependent). In females also delayed increased value of creatinine was recorded (out historical control limits). The NOAEL for reproduction and development was established as 1000 mg/kg body weight/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88756bd8-8595-4cf3-9747-88c346b9de7c/documents/13ffeb47-bcdd-421f-8dc8-1f8db86bd9b2_c6e311d1-706d-403d-8bcf-f039f03effc6.html,,,,,, Disodium 6-hydroxy-5-[[4-[[4-(phenylamino)-3-sulphonatophenyl]azo]naphthyl]azo]naphthalene-2-sulphonate,6262-07-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88756bd8-8595-4cf3-9747-88c346b9de7c/documents/13ffeb47-bcdd-421f-8dc8-1f8db86bd9b2_c6e311d1-706d-403d-8bcf-f039f03effc6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Disodium 6-hydroxy-5-[[4-[[4-(phenylamino)-3-sulphonatophenyl]azo]naphthyl]azo]naphthalene-2-sulphonate,6262-07-3," According to the study results (acute toxic class method) the value of LD50 of the test substance, Acid Black 26, for female rats is higher than 2000 mg/kg of body weight. A limit test for acute inhalation toxicity was performed according to OECD TG 403 methodology. The results of the test revealed the P-deposition with test substance particles but did not reveal any adverse effects on the health of the experimental animals and the value of LD50 for male/female rats is higher than 5200 mg/m³. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88756bd8-8595-4cf3-9747-88c346b9de7c/documents/15a4c70d-7af5-4541-a7a6-8b3bd64def57_c6e311d1-706d-403d-8bcf-f039f03effc6.html,,,,,, Disodium 6-hydroxy-5-[[4-[[4-(phenylamino)-3-sulphonatophenyl]azo]naphthyl]azo]naphthalene-2-sulphonate,6262-07-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88756bd8-8595-4cf3-9747-88c346b9de7c/documents/15a4c70d-7af5-4541-a7a6-8b3bd64def57_c6e311d1-706d-403d-8bcf-f039f03effc6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Disodium 6-hydroxy-5-[[4-[[4-(phenylamino)-3-sulphonatophenyl]azo]naphthyl]azo]naphthalene-2-sulphonate,6262-07-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88756bd8-8595-4cf3-9747-88c346b9de7c/documents/15a4c70d-7af5-4541-a7a6-8b3bd64def57_c6e311d1-706d-403d-8bcf-f039f03effc6.html,,inhalation,LC50,"5,200 mg/m3",no adverse effect observed, "Disodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-(phenylazo)naphthalene-2-sulphonate]",3626-36-6,NOAEL > 1000 mg/kg bw/day at 30 days ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edcfba0c-98e3-4914-89b5-a8c520c6ea95/documents/1149a81b-95b3-4e8e-8df9-f2e1f46a17b6_c7848300-094e-49c1-99d0-f47563866591.html,,,,,, "Disodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-(phenylazo)naphthalene-2-sulphonate]",3626-36-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edcfba0c-98e3-4914-89b5-a8c520c6ea95/documents/1149a81b-95b3-4e8e-8df9-f2e1f46a17b6_c7848300-094e-49c1-99d0-f47563866591.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Disodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-(phenylazo)naphthalene-2-sulphonate]",3626-36-6,Oral toxicity: LD50 > 2000 mg/kg bwDermal toxicity: LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edcfba0c-98e3-4914-89b5-a8c520c6ea95/documents/5015812b-93b1-4c85-a113-461d1a08c789_c7848300-094e-49c1-99d0-f47563866591.html,,,,,, "Disodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-(phenylazo)naphthalene-2-sulphonate]",3626-36-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edcfba0c-98e3-4914-89b5-a8c520c6ea95/documents/5015812b-93b1-4c85-a113-461d1a08c789_c7848300-094e-49c1-99d0-f47563866591.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-(phenylazo)naphthalene-2-sulphonate]",3626-36-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edcfba0c-98e3-4914-89b5-a8c520c6ea95/documents/5015812b-93b1-4c85-a113-461d1a08c789_c7848300-094e-49c1-99d0-f47563866591.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 7-[[2-(acetylamino)-4-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]phenyl]azo]naphthalene-1,3-disulphonate",68155-62-4, Not harmful/toxic if swallowed. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/579265ec-098f-4954-be5e-450b3e7f9624/documents/b2a7a441-c3e0-4106-9f81-cb60137dc0dc_044f6ceb-d85d-41e0-97a1-39f81ce2ea1d.html,,,,,, "Disodium 7-[[4,6-bis[(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate",68201-95-6, The NOAEL (No Observed Adverse Effect Level) for oral repeated dose toxicity was established as 1000 mg/kg body weight/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04e76916-ddf4-4147-b467-be17ee064774/documents/4e39aeca-b0f7-440d-bcbc-cc53f2582175_e2e3fb91-202c-4034-a48a-26deaa7985a0.html,,,,,, "Disodium 7-[[4,6-bis[(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate",68201-95-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04e76916-ddf4-4147-b467-be17ee064774/documents/4e39aeca-b0f7-440d-bcbc-cc53f2582175_e2e3fb91-202c-4034-a48a-26deaa7985a0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Disodium 7-[[4,6-bis[(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate",68201-95-6,Oral LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04e76916-ddf4-4147-b467-be17ee064774/documents/963ac2b8-cae4-4b28-b4ee-20b96c3dbe52_e2e3fb91-202c-4034-a48a-26deaa7985a0.html,,,,,, "Disodium 7-[[4,6-bis[(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate",68201-95-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04e76916-ddf4-4147-b467-be17ee064774/documents/963ac2b8-cae4-4b28-b4ee-20b96c3dbe52_e2e3fb91-202c-4034-a48a-26deaa7985a0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "disodium 7-{[4-chloro-6-(dodecylamino)-1,3,5-triazin-2-yl]amino}-4-hydroxy-3-[{4-[(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]naphthalene-2-sulfonate",145703-76-0,The substance resulted as non-toxic in a subacute (28 days) study in rats administered orally by gavage. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d0fb285-703e-4b42-8f25-68149641d214/documents/12a2e5fc-3b3d-4923-9238-46a3895ef2ce_90d8498c-0998-4fe5-97ef-1fa995151f93.html,,,,,, "disodium 7-{[4-chloro-6-(dodecylamino)-1,3,5-triazin-2-yl]amino}-4-hydroxy-3-[{4-[(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]naphthalene-2-sulfonate",145703-76-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d0fb285-703e-4b42-8f25-68149641d214/documents/12a2e5fc-3b3d-4923-9238-46a3895ef2ce_90d8498c-0998-4fe5-97ef-1fa995151f93.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "disodium 7-{[4-chloro-6-(dodecylamino)-1,3,5-triazin-2-yl]amino}-4-hydroxy-3-[{4-[(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]naphthalene-2-sulfonate",145703-76-0,"In rats, LD50 > 2000 mg/kg bw after oral and dermal exposure to test substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d0fb285-703e-4b42-8f25-68149641d214/documents/64bfc829-30f9-4408-bef2-91e7bd486628_90d8498c-0998-4fe5-97ef-1fa995151f93.html,,,,,, "disodium 7-{[4-chloro-6-(dodecylamino)-1,3,5-triazin-2-yl]amino}-4-hydroxy-3-[{4-[(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]naphthalene-2-sulfonate",145703-76-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d0fb285-703e-4b42-8f25-68149641d214/documents/64bfc829-30f9-4408-bef2-91e7bd486628_90d8498c-0998-4fe5-97ef-1fa995151f93.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "disodium 7-{[4-chloro-6-(dodecylamino)-1,3,5-triazin-2-yl]amino}-4-hydroxy-3-[{4-[(4-sulfonatophenyl)diazen-1-yl]phenyl}diazen-1-yl]naphthalene-2-sulfonate",145703-76-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d0fb285-703e-4b42-8f25-68149641d214/documents/64bfc829-30f9-4408-bef2-91e7bd486628_90d8498c-0998-4fe5-97ef-1fa995151f93.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Disodium 7-amino-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate,6300-50-1," Repeated dose oral toxicity information is derived from a 28 day oral toxicity study ( OECD 422, GLP compliant) conducted in rats on an analogue substance. The oral administration of the substance to rats by gavage, at dose levels of 750, 300 and 30 mg/ kg bw/day, resulted in treatment-related changes at 750 and 300 mg/kg bw/day. Effects at 300 mg/kg bw/day were considered not to represent an adverse effect. Therefore a ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was considered to be 300 mg/kg bw/day. The NOAEL has been used to derive the relevant DNEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c298b7e-0a3f-48df-91ee-daa7bc42e61e/documents/896b1b4a-5e74-4987-b578-65226690545e_d6942d5f-f54c-429b-8fa3-01d2a92685ff.html,,,,,, Disodium 7-amino-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate,6300-50-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c298b7e-0a3f-48df-91ee-daa7bc42e61e/documents/896b1b4a-5e74-4987-b578-65226690545e_d6942d5f-f54c-429b-8fa3-01d2a92685ff.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Disodium 7-amino-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate,6300-50-1, The acute toxicity of the substance has been determined in adequate studies in the rat following oral and dermal administration. No studies are available for inhalation. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c298b7e-0a3f-48df-91ee-daa7bc42e61e/documents/5519ab54-6e86-48ed-95fa-1f6b8c381920_d6942d5f-f54c-429b-8fa3-01d2a92685ff.html,,,,,, Disodium 7-amino-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate,6300-50-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c298b7e-0a3f-48df-91ee-daa7bc42e61e/documents/5519ab54-6e86-48ed-95fa-1f6b8c381920_d6942d5f-f54c-429b-8fa3-01d2a92685ff.html,,oral,LD50,"2,516 mg/kg bw",no adverse effect observed, Disodium 7-amino-4-hydroxy-3-[[4-[(4-sulphonatophenyl)azo]phenyl]azo]naphthalene-2-sulphonate,6300-50-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c298b7e-0a3f-48df-91ee-daa7bc42e61e/documents/5519ab54-6e86-48ed-95fa-1f6b8c381920_d6942d5f-f54c-429b-8fa3-01d2a92685ff.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Disodium 7-amino-4-hydroxy-3-[[5-hydroxy-6-(phenylazo)-7-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate,6227-02-7,Oral toxicity: LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/327be48a-3d8b-47e4-a788-c427f9d00e0f/documents/69f0d41f-a360-441d-8940-48ebbc9f75db_7fb30021-72b4-437e-b8ff-5f82284560b2.html,,,,,, Disodium 7-amino-4-hydroxy-3-[[5-hydroxy-6-(phenylazo)-7-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate,6227-02-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/327be48a-3d8b-47e4-a788-c427f9d00e0f/documents/69f0d41f-a360-441d-8940-48ebbc9f75db_7fb30021-72b4-437e-b8ff-5f82284560b2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Disodium 8-(phenylamino)-5-[[4-[(5-sulphonatonaphthyl)azo]naphthyl]azo]naphthalenesulphonate,3071-73-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c12fe45c-2211-4d02-a588-67ed0e18a502/documents/01d99226-27c2-4fa3-8e8d-4a1afa099dfa_9c7b1ad0-03fe-478a-8b36-8314b3b6649f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Disodium 8-(phenylamino)-5-[[4-[(5-sulphonatonaphthyl)azo]naphthyl]azo]naphthalenesulphonate,3071-73-6, LD50 (oral) > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c12fe45c-2211-4d02-a588-67ed0e18a502/documents/IUC5-3f627ada-3667-4755-bafe-b84a30db588a_9c7b1ad0-03fe-478a-8b36-8314b3b6649f.html,,,,,, Disodium 8-(phenylamino)-5-[[4-[(5-sulphonatonaphthyl)azo]naphthyl]azo]naphthalenesulphonate,3071-73-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c12fe45c-2211-4d02-a588-67ed0e18a502/documents/IUC5-3f627ada-3667-4755-bafe-b84a30db588a_9c7b1ad0-03fe-478a-8b36-8314b3b6649f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Disodium 8-[[4-[[(4-methylphenyl)sulphonyl]oxy]phenyl]azo]-5-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]naphthalene-1-sulphonate,72968-81-1," Acute oral toxicity, LD50: > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36633db8-8944-485e-81b9-31ae458cbbdb/documents/a29faa74-837a-4740-9605-976712e634a6_c3034fbd-85e1-4641-84e4-a91dc4294156.html,,,,,, Disodium 8-[[4-[[(4-methylphenyl)sulphonyl]oxy]phenyl]azo]-5-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]naphthalene-1-sulphonate,72968-81-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36633db8-8944-485e-81b9-31ae458cbbdb/documents/a29faa74-837a-4740-9605-976712e634a6_c3034fbd-85e1-4641-84e4-a91dc4294156.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium 8-hydroxynaphthalene-1,6-disulphonate",83732-80-3," Prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound 8-hydroxynaphthalene-1,6-disulfonate ( 83732-80-3). The study assumed the use of male and female Wistar rats in chronic study of 90 days. No significant alterations were noted at the dose level of 568.57mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for 8-hydroxynaphthalene-1,6-disulfonate is considered to be 568.57mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb75fe6c-279d-48d3-8d08-0f05a90a4185/documents/8bb4c013-5615-40c0-b79e-53f7e672e6c8_a70c541a-c483-4a48-bb98-52adb4a847e6.html,,,,,, "Disodium 8-hydroxynaphthalene-1,6-disulphonate",83732-80-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb75fe6c-279d-48d3-8d08-0f05a90a4185/documents/8bb4c013-5615-40c0-b79e-53f7e672e6c8_a70c541a-c483-4a48-bb98-52adb4a847e6.html,Chronic toxicity – systemic effects,oral,NOAEL,568.57 mg/kg bw/day,,rat "Disodium 8-hydroxynaphthalene-1,6-disulphonate",83732-80-3," Acute oral toxicity:  Acute oral toxicity dose (LD50) of Disodium 8-hydroxynaphthalene-1,6-disulfonate (CAS no: 83732-80-3) was predicted based on OECD QSAR toolbox 4064 mg/kg bw and different studies available on structurally similar read across substances Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (CAS No. 3567-66-6) >2000 mg/kg bw and Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (CAS no: 3734-67-6) >2000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Disodium 8-hydroxynaphthalene-1,6-disulfonate cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  Disodium 8-hydroxynaphthalene-1,6-disulfonate (CAS no: 83732-80-3) has very low vapour pressure (1.22E-16 Pa at 25°C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for Disodium 8-hydroxynaphthalene-1,6-disulfonate (CAS no: 83732-80-3) was predicted based on OECD QSAR toolbox 4668 mg/kg bwand differentstudies available for the structurally similar read across substances Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (CAS no: 3567-66-6) >2000 mg/kg bw and Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (CAS no: 3734-67-6) >2000 mg/kg bw. All these studies concluded that the LD50 value is>2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Disodium 8-hydroxynaphthalene-1,6-disulfonate cannot be classified for acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb75fe6c-279d-48d3-8d08-0f05a90a4185/documents/6a6d4903-2367-481d-9c0b-8b5d6c6ae7f2_a70c541a-c483-4a48-bb98-52adb4a847e6.html,,,,,, "Disodium 8-hydroxynaphthalene-1,6-disulphonate",83732-80-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb75fe6c-279d-48d3-8d08-0f05a90a4185/documents/6a6d4903-2367-481d-9c0b-8b5d6c6ae7f2_a70c541a-c483-4a48-bb98-52adb4a847e6.html,,oral,LD50,"4,064 mg/kg bw",no adverse effect observed, "Disodium 8-hydroxynaphthalene-1,6-disulphonate",83732-80-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb75fe6c-279d-48d3-8d08-0f05a90a4185/documents/6a6d4903-2367-481d-9c0b-8b5d6c6ae7f2_a70c541a-c483-4a48-bb98-52adb4a847e6.html,,dermal,LD50,"4,668 mg/kg bw",no adverse effect observed, Disodium adipate,7486-38-6,"There are no data available for disodium adipate. The IUCLID dataset and the present Human Health Hazard Assessment is based on the recent OECD/ICCA evaluation of adipic acid. For all systemic endpoints the hazards identified and discussed in the OECD SIDS Initial Assessment Report for adipic acid in 2004 are cited and additional updated relevant information is given in a separate heading. In aqueous media, disodium adipate and adipic acid acid dissociate into the corresponding anion (1,6-hexandioic acid ion) and the sodium ion and hydrogen ion (proton), respectively. Systemic toxicity of adipic acid and its disodium salt are thought to be an effect of the di-carboxylate ion rather than of the sodium ion or the hydrogen ion (proton), which are normal constituents in living systems and have no relevant toxicological properties at relevant doses. Therefore data on adipic acida are taken to evaluate the systemic toxicity of disodium adipate. Data on adipic acid: In a 2-year oral study adipic acid was of low repeated dose toxicity, however it was not tested according to modern standards. The NOAEL was 1% for male rats (approx. 750 mg/kg bw/day) and higher doses (3 and 5%) caused body weight retardation with no indication of specific target organ toxicity. The NOAEL for female rats was 1% (approx. 750 mg/kg bw/day), the highest dose tested in females. In humans no symptoms were reported after oral administration of up to 7 g adipic acid per day for up to 10 days to 7 volunteers to investigate compound excretion. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1d3f3ec-eb4a-4a3f-bf75-acd3540d7c42/documents/IUC5-21db9e22-3fdc-43c9-b305-6a0b0fdad487_c68e5e30-4126-4359-9b07-5cbd38cc8172.html,,,,,, Disodium adipate,7486-38-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1d3f3ec-eb4a-4a3f-bf75-acd3540d7c42/documents/IUC5-21db9e22-3fdc-43c9-b305-6a0b0fdad487_c68e5e30-4126-4359-9b07-5cbd38cc8172.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,, Disodium adipate,7486-38-6,There are no data available for disodium adipate. Adipic acid is of very low acute toxicity. The oral and dermal LD50 in rats are > 5000 mg/kg bw. In an acute inhalation test neither mortality nor symptoms were observed during and after 4 hour exposure to 7700 mg/m3 of adipic acid. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1d3f3ec-eb4a-4a3f-bf75-acd3540d7c42/documents/IUC5-335b8f4c-c2c7-47c3-b18e-efeb9216952c_c68e5e30-4126-4359-9b07-5cbd38cc8172.html,,,,,, Disodium adipate,7486-38-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1d3f3ec-eb4a-4a3f-bf75-acd3540d7c42/documents/IUC5-335b8f4c-c2c7-47c3-b18e-efeb9216952c_c68e5e30-4126-4359-9b07-5cbd38cc8172.html,,oral,LD50,"5,560 mg/kg bw",, Disodium adipate,7486-38-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1d3f3ec-eb4a-4a3f-bf75-acd3540d7c42/documents/IUC5-335b8f4c-c2c7-47c3-b18e-efeb9216952c_c68e5e30-4126-4359-9b07-5cbd38cc8172.html,,dermal,discriminating dose,"7,940 mg/kg bw",, Disodium adipate,7486-38-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1d3f3ec-eb4a-4a3f-bf75-acd3540d7c42/documents/IUC5-335b8f4c-c2c7-47c3-b18e-efeb9216952c_c68e5e30-4126-4359-9b07-5cbd38cc8172.html,,inhalation,discriminating conc.,"7,700 mg/m3",, "Disodium ar,ar'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[(4-chlorophenoxy)benzenesulphonate]",71720-84-8, Oral LD50 (female) > 2000 mg/kg body weight ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59cc8e51-14dc-44f4-a3e7-304c8e02d06b/documents/cdaa4511-a7cd-4cc5-9e6c-6d87cb729973_74071aee-6c7e-4355-aeab-7886ad1bed8b.html,,,,,, Disodium dihydrogen ethylenediaminetetraacetate,139-33-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Sufficient quality due to guideline study (OECD TG 413) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 103-week feeding study ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a03acefb-a4aa-4b5b-ad19-8a51b6993253/documents/IUC5-de4e31a0-9174-44e5-b6bb-aa405352eff5_bf637d6d-dc08-4bcf-b992-6a0e498ec4cc.html,,,,,, Disodium dihydrogen ethylenediaminetetraacetate,139-33-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a03acefb-a4aa-4b5b-ad19-8a51b6993253/documents/IUC5-de4e31a0-9174-44e5-b6bb-aa405352eff5_bf637d6d-dc08-4bcf-b992-6a0e498ec4cc.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Disodium dihydrogen ethylenediaminetetraacetate,139-33-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a03acefb-a4aa-4b5b-ad19-8a51b6993253/documents/IUC5-de4e31a0-9174-44e5-b6bb-aa405352eff5_bf637d6d-dc08-4bcf-b992-6a0e498ec4cc.html,Repeated dose toxicity – local effects,inhalation,NOAEC,3 mg/m3,adverse effect observed,rat Disodium dihydrogen ethylenediaminetetraacetate,139-33-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Comparable to OECD 401 guideline study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): OECD TG 412 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a03acefb-a4aa-4b5b-ad19-8a51b6993253/documents/IUC5-524f7d0a-b512-4d81-8e3d-7b323064dda9_bf637d6d-dc08-4bcf-b992-6a0e498ec4cc.html,,,,,, Disodium dihydrogen ethylenediaminetetraacetate,139-33-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a03acefb-a4aa-4b5b-ad19-8a51b6993253/documents/IUC5-524f7d0a-b512-4d81-8e3d-7b323064dda9_bf637d6d-dc08-4bcf-b992-6a0e498ec4cc.html,,oral,LD50,"2,800 mg/kg bw",adverse effect observed, Disodium dihydrogen ethylenediaminetetraacetate,139-33-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a03acefb-a4aa-4b5b-ad19-8a51b6993253/documents/IUC5-524f7d0a-b512-4d81-8e3d-7b323064dda9_bf637d6d-dc08-4bcf-b992-6a0e498ec4cc.html,,inhalation,,30 mg/m3,adverse effect observed, Disodium disilicate,13870-28-5,"No studies are available with disodium disilicate (delta-crystalline). Read across to repeated dose toxicity studies with sodium silicate or sodium metasilicate ranging from 4 weeks to 180 days in rats, mice and dogs was done. The only treatment-related effects observed in rats were:- polydipsia, polyuria and soft stools at 2400 mg/kg bw/day (sodium silicate of unspecified MR; 4 weeks exposure).- Reduction of blood plasma Ca and Mg and liver Zn concentrations at 1259 mg/kg bw/day (sodium metasilicate, pentahydrate; 8 weeks exposure).In female mice, a reduced pituitary gland weight was observed at 716 - 892 mg/kg bw/day (sodium metasilicate; 3 months exposure). Dogs exhibited gross cortical lesions of the kidneys, polydipsia, polyuria and soft faeces at 2400 mg/kg bw/day (sodium silicate of unspecified MR; 4 weeks exposure). From these studies a NOAEL (180 days) of 159 mg/kg bw/day for rats was established. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8ed3dd7-b3e0-4607-99e9-9aaff8b7e742/documents/IUC5-96240481-e6a5-4abd-91a4-d454bf0cdfbb_08b1ef35-70db-46a0-83c5-81f9920ac46e.html,,,,,, Disodium disilicate,13870-28-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8ed3dd7-b3e0-4607-99e9-9aaff8b7e742/documents/IUC5-96240481-e6a5-4abd-91a4-d454bf0cdfbb_08b1ef35-70db-46a0-83c5-81f9920ac46e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,159 mg/kg bw/day,,rat Disodium disilicate,13870-28-5,The test substance disodium disilicate (delta-crystalline) was examined in an acute oral toxicity study and in two inhalation toxicity studies in rats. The inhalation toxicity studies included an acute inhalation toxicity study in which the rats were exposed to the test substance as aerosol via the nose for 4 hours followed by a 22 day observation period and a 3-day whole-body inhalation study in which the rats were exposed to the test substance as dust for 6 hours per day for 3 days followed by an observation period of 14 days. No biochemical/cytological changes in the bronchoalveolar lavage fluid (BALF) were observed in the 3-day whole-body inhalation study and the following toxicological endpoints obtained from the 3 studies assisted in the test substance classification: Oral LD50 male animals: 2507 mg/kg bwOral LD50: female animals 2000-3150 mg/kg bwInhalation LC50 male and female rats > 3.5 mg/LInhalation NOEL male rats: 10.8 mg/m3 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8ed3dd7-b3e0-4607-99e9-9aaff8b7e742/documents/IUC5-9dbcf9cb-ca2c-45ea-ae57-f3d17f68af39_08b1ef35-70db-46a0-83c5-81f9920ac46e.html,,,,,, Disodium disilicate,13870-28-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8ed3dd7-b3e0-4607-99e9-9aaff8b7e742/documents/IUC5-9dbcf9cb-ca2c-45ea-ae57-f3d17f68af39_08b1ef35-70db-46a0-83c5-81f9920ac46e.html,,oral,LD50,"2,000 mg/kg bw",, Disodium disilicate,13870-28-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8ed3dd7-b3e0-4607-99e9-9aaff8b7e742/documents/IUC5-9dbcf9cb-ca2c-45ea-ae57-f3d17f68af39_08b1ef35-70db-46a0-83c5-81f9920ac46e.html,,inhalation,LC50,10.8 mg/m3,, Disodium hydrogen bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-),12392-64-2,In a study according to OECD guideline 422 on the analogue substance no adverse effects at all were observed in parental as well as in offspring animals. The NOAEL regarding systemic toxicity was 1000 mg/kg/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/456b8d72-ff02-4d4a-89e1-cbb39bf2d163/documents/IUC5-c85ffe86-2846-4dba-ba68-412785546ec2_f4cc6587-0715-490f-911d-96899ffbf911.html,,,,,, Disodium hydrogen bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-),12392-64-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/456b8d72-ff02-4d4a-89e1-cbb39bf2d163/documents/IUC5-c85ffe86-2846-4dba-ba68-412785546ec2_f4cc6587-0715-490f-911d-96899ffbf911.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Disodium hydrogen bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-),12392-64-2,"Acute oral toxicity, rats (m/f), single oral exposure (OECD 401), LD50 > 2000 mg/kg bwAcute dermal toxicity, analogue substance, rats(m/f), semiocclusive, LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/456b8d72-ff02-4d4a-89e1-cbb39bf2d163/documents/IUC5-a857c19e-e700-420b-a241-2528bf275196_f4cc6587-0715-490f-911d-96899ffbf911.html,,,,,, Disodium hydrogen bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-),12392-64-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/456b8d72-ff02-4d4a-89e1-cbb39bf2d163/documents/IUC5-a857c19e-e700-420b-a241-2528bf275196_f4cc6587-0715-490f-911d-96899ffbf911.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Disodium hydrogen bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-),12392-64-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/456b8d72-ff02-4d4a-89e1-cbb39bf2d163/documents/IUC5-a857c19e-e700-420b-a241-2528bf275196_f4cc6587-0715-490f-911d-96899ffbf911.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromate(3-)",6408-29-3,Oral LD50 rat > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40de2e90-946d-4561-a455-0e69d5d36346/documents/f47a751a-6c31-46b2-8933-e6c420c36103_c9f83b14-b660-4e14-bd46-9da694821ae2.html,,,,,, "Disodium hydrogen bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromate(3-)",6408-29-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40de2e90-946d-4561-a455-0e69d5d36346/documents/f47a751a-6c31-46b2-8933-e6c420c36103_c9f83b14-b660-4e14-bd46-9da694821ae2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Disodium L-tyrosinate,69847-45-6," Oral: In an in vivo acute oral toxicity study in rats (Acute-Toxic-Class Method = ATC-Method) according to OECD Guideline 423, a LD50 > 2000 mg/kg bw was determined (UN GHS: No Category) (reference 7.2.1-1). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c19532d5-a866-48cd-bf4e-bceaecce4fa4/documents/bbf2838b-3b9b-469d-b78b-3f7faab3551a_98f7fcbc-d067-4ca5-94d3-412ff7494627.html,,,,,, Disodium L-tyrosinate,69847-45-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c19532d5-a866-48cd-bf4e-bceaecce4fa4/documents/bbf2838b-3b9b-469d-b78b-3f7faab3551a_98f7fcbc-d067-4ca5-94d3-412ff7494627.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Disodium naphthalene-1,5-disulphonate",1655-29-4,Early study conducated similar to OECD TG 401 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a61a9924-129d-49e0-aa8e-b285d0bb6e82/documents/f58e9938-c199-4259-a364-4a3fa1e1ccdd_fe013876-24c8-4f8c-98fb-46a89970bed0.html,,,,,, "Disodium naphthalene-1,5-disulphonate",1655-29-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a61a9924-129d-49e0-aa8e-b285d0bb6e82/documents/f58e9938-c199-4259-a364-4a3fa1e1ccdd_fe013876-24c8-4f8c-98fb-46a89970bed0.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Disodium octaborate,12008-41-2," A number of sub-chronic and chronic studies on boric acid and disodium tetraborate decahydrate were carried out in rats, mice and dogs. In some cases these studies are research studies (Dixon et al, 1976; Seal and Weeth, 1980; Lee et al., 1978; Treinen and Chapin, 1991; Ku et al., 1993), but most support that boron can cause adverse haematological effects and that the main target organ of boron toxicity is the testis. The NOAEL for fertility effects is equivalent to 17.5 mg B/kg bw/day that corresponds to NOAEL of 83.3 mg disodium octaborate /kg bw (Weir, 1966). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/81589e44-5730-4949-a349-27580ec34731/documents/859ec989-543e-4673-80e1-77d9bae103de_169c4240-54f7-4e8a-9395-913ecaf96bd2.html,,,,,, Disodium octaborate,12008-41-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/81589e44-5730-4949-a349-27580ec34731/documents/859ec989-543e-4673-80e1-77d9bae103de_169c4240-54f7-4e8a-9395-913ecaf96bd2.html,Short-term repeated dose toxicity – systemic effects,inhalation,BMCL05,86.6 mg/m3,,rat Disodium octaborate,12008-41-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/81589e44-5730-4949-a349-27580ec34731/documents/859ec989-543e-4673-80e1-77d9bae103de_169c4240-54f7-4e8a-9395-913ecaf96bd2.html,Chronic toxicity – systemic effects,oral,NOAEL,83.3 mg/kg bw/day,,rat Disodium octaborate,12008-41-2," Acute oral, dermal and inhalation toxicity studies have been performed with disodium octaborate tetrahydrate. Experimental data showed low acute toxicity to disodium octaborate tetrahydrate. The mean of the male and female values were obtained from the key study (oral route; Doyle 1988). The LD50 (oral) is equivalent to 534.5 mg B/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81589e44-5730-4949-a349-27580ec34731/documents/a6e11b8b-1399-4a3c-b4df-1d7e05dfa3a0_169c4240-54f7-4e8a-9395-913ecaf96bd2.html,,,,,, Disodium octaborate,12008-41-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81589e44-5730-4949-a349-27580ec34731/documents/a6e11b8b-1399-4a3c-b4df-1d7e05dfa3a0_169c4240-54f7-4e8a-9395-913ecaf96bd2.html,,oral,LD50,"2,550 mg/kg bw",no adverse effect observed, Disodium octaborate,12008-41-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81589e44-5730-4949-a349-27580ec34731/documents/a6e11b8b-1399-4a3c-b4df-1d7e05dfa3a0_169c4240-54f7-4e8a-9395-913ecaf96bd2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Disodium octaborate,12008-41-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81589e44-5730-4949-a349-27580ec34731/documents/a6e11b8b-1399-4a3c-b4df-1d7e05dfa3a0_169c4240-54f7-4e8a-9395-913ecaf96bd2.html,,inhalation,LC50,"2,010 mg/m3",no adverse effect observed, Disodium oxybis[methylbenzenesulphonate],73037-34-0,There is no sub-chronic study available. In the subacute oral study in rats no hazard was identified resulting in a NOEL of 1000 mg/kg bw/day. It is assumed that prolongation of treatment time does not provide additional information on toxic effects. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0962c39f-e6d4-4a62-a364-eaf8d535702e/documents/IUC5-bb88209a-a314-475a-adad-18d7e9918414_fb1ef657-4165-435a-945e-5ce229e978c2.html,,,,,, Disodium oxybis[methylbenzenesulphonate],73037-34-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0962c39f-e6d4-4a62-a364-eaf8d535702e/documents/IUC5-bb88209a-a314-475a-adad-18d7e9918414_fb1ef657-4165-435a-945e-5ce229e978c2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Disodium oxybis[methylbenzenesulphonate],73037-34-0,"The acute toxicity of ditolylether disulfonic acid disodium salt, isomer mixture was tested using the oral and the dermal route yielding an LD50 >2000 mg/kg bw for both application routes. In none of the studies amanimals died or displayed signs of intoxication. Thus, the conditions according to Regulation (EC) 1907/2006 (REACH) ANNEX VIII, section 8.5 column 2 are fulfilled. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0962c39f-e6d4-4a62-a364-eaf8d535702e/documents/IUC5-a1cc45c6-5f72-454e-8c57-0e2e8897cbeb_fb1ef657-4165-435a-945e-5ce229e978c2.html,,,,,, Disodium oxybis[methylbenzenesulphonate],73037-34-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0962c39f-e6d4-4a62-a364-eaf8d535702e/documents/IUC5-a1cc45c6-5f72-454e-8c57-0e2e8897cbeb_fb1ef657-4165-435a-945e-5ce229e978c2.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Disodium oxybis[methylbenzenesulphonate],73037-34-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0962c39f-e6d4-4a62-a364-eaf8d535702e/documents/IUC5-a1cc45c6-5f72-454e-8c57-0e2e8897cbeb_fb1ef657-4165-435a-945e-5ce229e978c2.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Disodium peroxide,1313-60-6," The exothermic and instantaneous hydrolysis of disodium peroxide was confirmed by industrial practice (see section 5.1.2. of the technical dossier). In contact with moist skin or mucous membranes (water), disodium peroxide is quasi-instantaneously decomposed into sodium hydroxide and oxygen. Disodium peroxide appears then not available in the body due to its quasi-instantaneously degradation on contact with moist skin or mucous membranes. For these reasons, this approach was followed for the hazard characterization of disodium peroxide: Short term toxicity and local toxicity endpoints were waived, based on corrosive potential and for animal welfare consideration Repeated toxicity endpoints were based on breakdown product (sodium hydroxide). There are sufficient data on the breakdown product (sodium hydroxide n°CAS: 1310 -73 -2) which were already evaluated (European RAR and REACH registration). This breakdown substance is exempted to Registration following Annex V (Entry I) for this register dossier. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8ea5b06-bc57-42cf-a127-fa7d79fc2f66/documents/f88ef279-6a04-4d29-b8b8-f1b71e0e1fd4_eb4daa49-3f43-429d-8236-0c4c38b599e6.html,,,,,, Disodium peroxide,1313-60-6," The exothermic and instantaneous hydrolysis of disodium peroxide (Na2O2 - n°CAS 1313 -60 -6) according the reaction: Na2O2 + H2O -> 2NaOH + 1/2O2 was confirmed by industrial practice (see section 5.1.2 of the IUCLID dossier). After the reaction, the pH of the solution is > 12. Therefore, disodium peroxide is considered as corrosive and test for acute toxicity are not performed for animal welfare considerations. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8ea5b06-bc57-42cf-a127-fa7d79fc2f66/documents/8043e7d8-3da4-42e7-a897-e514d75ca449_eb4daa49-3f43-429d-8236-0c4c38b599e6.html,,,,,, Disodium phosphonate,13708-85-5," Classification in one of the hazard categories of the hazard class ""Specific target organ toxicity — repeated exposure"" according to (EU) No. 1272/2008 is not required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07e98054-4c30-4d72-b91f-1731b379b26b/documents/IUC5-bade0dda-2eb1-42cc-9cde-c2e4d6752018_1cbf6e86-15b8-4952-89fd-445fb005cc2e.html,,,,,, Disodium phosphonate,13708-85-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07e98054-4c30-4d72-b91f-1731b379b26b/documents/IUC5-bade0dda-2eb1-42cc-9cde-c2e4d6752018_1cbf6e86-15b8-4952-89fd-445fb005cc2e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Disodium phosphonate,13708-85-5,"The LD50 for oral exposure was determined to be 4,000 mg/kg bw.The LD50 for dermal exposure was determined to be higher than 2,000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07e98054-4c30-4d72-b91f-1731b379b26b/documents/IUC5-a027eaa2-0cf4-41f2-adc8-806ff3a47d01_1cbf6e86-15b8-4952-89fd-445fb005cc2e.html,,,,,, Disodium phosphonate,13708-85-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07e98054-4c30-4d72-b91f-1731b379b26b/documents/IUC5-a027eaa2-0cf4-41f2-adc8-806ff3a47d01_1cbf6e86-15b8-4952-89fd-445fb005cc2e.html,,oral,LD50,"4,000 mg/kg bw",no adverse effect observed, Disodium phosphonate,13708-85-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07e98054-4c30-4d72-b91f-1731b379b26b/documents/IUC5-a027eaa2-0cf4-41f2-adc8-806ff3a47d01_1cbf6e86-15b8-4952-89fd-445fb005cc2e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Disodium phthalate,15968-01-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Read-across approach. Klimisch 2. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/104c9103-bb01-471f-8d66-91ae208146ca/documents/IUC5-4ac2c73a-ee11-4a5f-9b89-7ac984ef9e95_f476ca6b-67ec-4c4b-9e1b-efb9d4c4de18.html,,,,,, Disodium phthalate,15968-01-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/104c9103-bb01-471f-8d66-91ae208146ca/documents/IUC5-4ac2c73a-ee11-4a5f-9b89-7ac984ef9e95_f476ca6b-67ec-4c4b-9e1b-efb9d4c4de18.html,Chronic toxicity – systemic effects,oral,NOAEL,709 mg/kg bw/day,,rat Disodium phthalate,15968-01-1,"Key study: Acute oral: Read-across from experimental results on an analogue: Similar to OECD guideline 401. No GLP data.LD50 = 3200 mg/kg bw Key study: Acute dermal: Experimental results: OECD guideline 402 and EU method B.3. GLP study.LD50 > 2000 mg/kg bw Acute inhalation: Data waiving: In accordance with column 2 of REACH Annex VIII, the study does not need to be conducted since exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/104c9103-bb01-471f-8d66-91ae208146ca/documents/IUC5-f254f280-9a3e-495c-81f6-9707d9997c54_f476ca6b-67ec-4c4b-9e1b-efb9d4c4de18.html,,,,,, Disodium phthalate,15968-01-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/104c9103-bb01-471f-8d66-91ae208146ca/documents/IUC5-f254f280-9a3e-495c-81f6-9707d9997c54_f476ca6b-67ec-4c4b-9e1b-efb9d4c4de18.html,,oral,LD50,"3,200 mg/kg bw",no adverse effect observed, Disodium phthalate,15968-01-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/104c9103-bb01-471f-8d66-91ae208146ca/documents/IUC5-f254f280-9a3e-495c-81f6-9707d9997c54_f476ca6b-67ec-4c4b-9e1b-efb9d4c4de18.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Disodium piperazine-1,4-diethanesulphonate",76836-02-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/075c0b7a-3169-483e-8480-31e51b2d374f/documents/8065768d-266d-4b8f-85a5-d65c9945bf48_255e4843-6614-4206-aab3-a01a8ffd883a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Disodium tetrachloropalladate,13820-53-6,"A GLP-compliant study according to OECD N°422 was performed to obtain information on the possible toxic effects of disodium tetrachloropalladate following repeated (daily) administration at a constant concentration in pelleted diet to Wistar (Crl:WI) rats at 3 dose levels (1000, 3000 and 10000 ppm test item in diet). A control group received non-treated control diet. Under the conditions of this study, the dietary administration of disodium tetrachloropalladate to Wistar rats did not result in test item related mortality. The NOAEL for systemic toxicity of the parental generation was considered to be 3000 ppm (corresponding to 272 mg/kg bw/day) based on effects on body weight, body weight gain and food consumption at 10000 ppm. No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Overall, good-quality database which meets REACH Standard Information Requirements. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c70d7cd-c4cc-467b-a8b5-d13cee0ef0d9/documents/IUC5-92b97b13-b893-4959-bdee-9b19888d4350_0b6669c8-8771-44c1-a221-e0c8eea82156.html,,,,,, Disodium tetrachloropalladate,13820-53-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c70d7cd-c4cc-467b-a8b5-d13cee0ef0d9/documents/IUC5-92b97b13-b893-4959-bdee-9b19888d4350_0b6669c8-8771-44c1-a221-e0c8eea82156.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,272 mg/kg bw/day,,rat Disodium tetrachloropalladate,13820-53-6," An acute oral LD50 value of between 500 and 2000 mg/kg bw was determined for disodium tetrachloropalladate in male and female rats (Middleton and Husband, 1978). No relevant acute inhalation or dermal toxicity data were identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c70d7cd-c4cc-467b-a8b5-d13cee0ef0d9/documents/IUC5-bf176bcf-0799-4456-89ea-7b8f5fcadb14_0b6669c8-8771-44c1-a221-e0c8eea82156.html,,,,,, Disodium tetrachloropalladate,13820-53-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c70d7cd-c4cc-467b-a8b5-d13cee0ef0d9/documents/IUC5-bf176bcf-0799-4456-89ea-7b8f5fcadb14_0b6669c8-8771-44c1-a221-e0c8eea82156.html,,oral,discriminating dose,500 mg/kg bw,adverse effect observed, Disodium tin hexahydroxide,12027-70-2," According to the relvant study for subacute chronic toxicity a NOAL of 1 % in diet was determined. Under consideration of a body of 250g / rat the folowing NOAEL could be calculated from the raw data: NOAEL (male( = 517.14 mg SnO2/kg bw day NOAEL(female) 408,57 mg SnO2 /kg bw day. So the female aninal is the most sensitive species, thus the NOAEL for Sodiums stabbate is 723.01 mg / kg /bw day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec688c40-ea9b-446d-a71a-7a1c82d09e2b/documents/d1a9c2e3-49f1-46b3-8021-73a48caa98a1_df6b3fc5-d2e5-47fd-a571-11947475e950.html,,,,,, Disodium tin hexahydroxide,12027-70-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec688c40-ea9b-446d-a71a-7a1c82d09e2b/documents/d1a9c2e3-49f1-46b3-8021-73a48caa98a1_df6b3fc5-d2e5-47fd-a571-11947475e950.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,723.09 mg/kg bw/day,,rat Disodium titanate,12034-34-3,"Acute toxicity, oral:LD50 > 2000 mg/kg bw for rat ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e52c88f-b7d4-4eb2-8fff-ed4911a32f67/documents/IUC5-ab9eae92-1587-46e8-a0bd-d19f6d824266_7f77747b-4211-45f9-9c20-35167d8b7ec3.html,,,,,, Disodium wolframate,13472-45-2,"A repeated dose study on sodium tungstate was sponsored conducted the United States Army Center for Health Promotion and Preventive Medicine and published by McCain et al. (2015). The 90-day oral toxicity study was conducted in rats according to the procedure described in the Environmental Protection Agency (EPA) Health Effects Testing Guidelines (40 CFR, Part 798.2650) in compliance with Good Laboratory Practice. Briefly, this study of the subchronic toxicity of sodium tungstate dihydrate aqueous solution in male and female Sprague-Dawley rats was evaluated by daily oral gavage of 0, 10, 75, 125, or 200 mg/kg bw/d for 90 days. Measured parameters included food consumption, body weight measurements, hematology, clinical chemistry, and histopathological changes. There was a significant decrease in food consumption and body weight gain in males at 200 mg/kg bw/d from days 77 to 90; however, there was no effect in food consumption and body weights in females. There were no changes in the hematological and clinical parameters studied. Histopathological changes were seen in kidney of male and female and epididymis of male rats. The histopathological changes observed in the kidneys of male and female rats dosed at 125 or 200 mg/k/d consisting of mild to severe cortical tubule basophilia in 2 high-dose groups. Histological changes in epididymides included intraluminal hypospermia with cell debris in the 200 mg/kg bw/day dosed male rats. Histopathological changes were observed in the glandular stomach including inflammation and metaplasia in the high-dose groups (125 or 200 mg/kg bw/day) of both sexes of rats. Based on histopathology effects seen in the kidneys, the lowest observable adverse effect level was 125 mg/kg bw/d and the no observable adverse effect level was 75 mg/kg bw/d in both sexes of rats for oral subchronic toxicity. The USEPA’s Benchmark Dose Software (BMDS, Version 1.4.1) was used to model the data to derive a BMDL10. The lowest (most precautionary) BMDL10 from the renal toxicity endpoint in the 90-day oral toxicity study was 102 mg/kg bw/d. In addition to McCain et al. (2015) rat oral 90-day repeated dose study, the US National Toxicology Program (NTP) has conducted two additional 90-day drinking water studies of sodium tungstate Dihydrate, one in Sprague-Dawley rats and a second one in B6C3F1 mice (10/sex/species/dose). The study design included doses of 0, 125, 250, 500, 1000, or 2000 mg/L.  There were no early deaths during the 3-month rat study. When compared to the vehicle control group, final mean body weights were lower for the 1,000 and 2,000 mg/L males and 2,000 mg/L females. Water consumption was lower for the 1,000 and 2,000 mg/L males and females. The urine xanthine/creatinine ratios were significantly increased in all male and female exposed groups. Serum insulin concentrations were significantly decreased in the 2,000 mg/L males relative to the vehicle control males. Significantly decreased absolute weights were observed in several organs but were considered secondary to body weights reductions. Exposure-related histological lesions were limited to the kidneys and included increased incidences of renal tubule regeneration in the 1,000 and 2,000 mg/L males and females; the increases in the 2,000 mg/L groups were significant relative to the vehicle control group. In the mice study, a decreased water consumption was observed in 1000 (11%) and 2000 mg/L (16%) male mice. During the 13-week phase of the study, there was no effect on survival, hematology, or organ weights in mice. Renal tubule regeneration was characterized by hyperplasia of tubular epithelial cells with cytoplasmic basophilia, nuclear crowding, karyomegaly, and occasional mitotic figures. Total tungsten concentrations were generally dose proportional in blood and urine. The micronucleus assay was negative in mice. The Comet assay was positive in the liver and ileum of male mice and negative in the blood and kidney of mice. The kidney appeared to be the only major target organ following exposure of mice to sodium tungstate dihydrate at water concentrations of 1000 and 2000 mg/L. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The reliability of this study for the substance tested is a K1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ca022d1-b2eb-4286-ade4-394078ad4c19/documents/f76fb965-57a8-4a03-826d-82c7a613f354_725db7ac-dc09-4331-959d-461d063f0346.html,,,,,, Disodium wolframate,13472-45-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ca022d1-b2eb-4286-ade4-394078ad4c19/documents/f76fb965-57a8-4a03-826d-82c7a613f354_725db7ac-dc09-4331-959d-461d063f0346.html,Sub-chronic toxicity – systemic effects,oral,BMDL10,102 mg/kg bw/day,,rat Disodium wolframate,13472-45-2," In an acute oral toxicity study conducted on rats and according to OECD 401, the LD50 for males/females was calculated to be 1453 mg/kg, for females was calculated to be 1373 mg/kg, and for males was calculated to be 1539 mg/kg. In an acute inhalation toxicity study conducted on rats and according to OECD 403, the rat inhalation LC50 was determined to be in excess of 5.01 mg/L. There were no deaths and no evidence of a systemic response in any animal throughout the study (OECD 402) following a single dermal application of the test substance to rats at a dose level of 2000 mg/kg-bw.  The acute lethal dose was determined to be greater than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ca022d1-b2eb-4286-ade4-394078ad4c19/documents/IUC5-b4efefb2-1756-481e-a77a-f57e59b00822_725db7ac-dc09-4331-959d-461d063f0346.html,,,,,, Disodium wolframate,13472-45-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ca022d1-b2eb-4286-ade4-394078ad4c19/documents/IUC5-b4efefb2-1756-481e-a77a-f57e59b00822_725db7ac-dc09-4331-959d-461d063f0346.html,,oral,LD50,"1,539 mg/kg bw",no adverse effect observed, Disodium wolframate,13472-45-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ca022d1-b2eb-4286-ade4-394078ad4c19/documents/IUC5-b4efefb2-1756-481e-a77a-f57e59b00822_725db7ac-dc09-4331-959d-461d063f0346.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Disodium wolframate,13472-45-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ca022d1-b2eb-4286-ade4-394078ad4c19/documents/IUC5-b4efefb2-1756-481e-a77a-f57e59b00822_725db7ac-dc09-4331-959d-461d063f0346.html,,inhalation,LC50,> 5.01 mg/L,no adverse effect observed, "Disodium; 4-Amino-3-{4-[4-(2,4-diamino-phenylazo)-benzenesulfonylamino]-phenylazo}-5-hydroxy-6-phenylazo-naphthalene-2,7-disulfonate",157577-99-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/230df9e7-f4d1-4325-96c7-568bec06991e/documents/b39c1d9a-848e-48c1-8fc5-8a0ba77ece0e_2ef3e5fc-231b-49b7-944e-3b71eaf97c53.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Disodium; 4-Amino-3-{4-[4-(2,4-diamino-phenylazo)-benzenesulfonylamino]-phenylazo}-5-hydroxy-6-phenylazo-naphthalene-2,7-disulfonate",157577-99-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/230df9e7-f4d1-4325-96c7-568bec06991e/documents/b39c1d9a-848e-48c1-8fc5-8a0ba77ece0e_2ef3e5fc-231b-49b7-944e-3b71eaf97c53.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,40 mg/kg bw/day,,rat "Disodium; 4-Amino-3-{4-[4-(2,4-diamino-phenylazo)-benzenesulfonylamino]-phenylazo}-5-hydroxy-6-phenylazo-naphthalene-2,7-disulfonate",157577-99-6, NOAEL oral rat > 2000 mg/kg NOAEL dermal rat > 2000 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/230df9e7-f4d1-4325-96c7-568bec06991e/documents/IUC5-4c358cbc-bf45-4158-83d8-f0789f12298e_2ef3e5fc-231b-49b7-944e-3b71eaf97c53.html,,,,,, "Disodium; 4-Amino-3-{4-[4-(2,4-diamino-phenylazo)-benzenesulfonylamino]-phenylazo}-5-hydroxy-6-phenylazo-naphthalene-2,7-disulfonate",157577-99-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/230df9e7-f4d1-4325-96c7-568bec06991e/documents/IUC5-4c358cbc-bf45-4158-83d8-f0789f12298e_2ef3e5fc-231b-49b7-944e-3b71eaf97c53.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Disodium; 4-Amino-3-{4-[4-(2,4-diamino-phenylazo)-benzenesulfonylamino]-phenylazo}-5-hydroxy-6-phenylazo-naphthalene-2,7-disulfonate",157577-99-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/230df9e7-f4d1-4325-96c7-568bec06991e/documents/IUC5-4c358cbc-bf45-4158-83d8-f0789f12298e_2ef3e5fc-231b-49b7-944e-3b71eaf97c53.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (Fischer-Tropsch), C8-10-branched and linear",1345668-41-8,InhalationNOAEC (systemic): 8117 mg/m³ ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4bacf10d-ecac-45bf-b226-915c0508ebad/documents/IUC5-8b1a05bb-2114-42e6-b106-3b8ff2e07d1e_9f483a30-d48b-452e-9037-f99c10b3bc7d.html,,,,,, "Distillates (Fischer-Tropsch), C8-10-branched and linear",1345668-41-8,Oral LD50 (rat) > 5840 mg/kg bwDermal LC 50 (rat) > 2920 mg/kg bwInhalative LD50 (rat) > 23300 mg/m³ ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4bacf10d-ecac-45bf-b226-915c0508ebad/documents/IUC5-cb8aa5ec-62bb-4c1f-b1dc-c28a58f6dc66_9f483a30-d48b-452e-9037-f99c10b3bc7d.html,,,,,, "C18-C50 branched, cyclic and linear hydrocarbons - Distillates",848301-69-9,"90 day repeated dose oral toxicity study in the rat: - treatment-related effects in animals of either sex treated with 1000 and 200 mg/kg/day- no such effects were detected in animals of either sex treated with 50 mg/kg/day and the “No Observed Effect Level” (NOEL) was, therefore, considered to be 50 mg/kg/day- the effects detected at 200 and 1000 mg/kg/day in the lungs and mesenteric lymph nodes were considered to be secondary to aspiration following the oral gavage and a normal response of the lymph nodes clearing the material, respectively, and were therefore not considered to be an adverse effect of treatment; the “No Observed Adverse Effect Level” (NOAEL) was therefore considered to be 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4231c860-f422-4c30-8129-a94c5eafed93/documents/IUC5-6984d33f-5aae-465e-98f6-d970b0fa26aa_97c7ab0f-e4b0-4638-b352-57fd4b88ccaa.html,,,,,, "C18-C50 branched, cyclic and linear hydrocarbons - Distillates",848301-69-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4231c860-f422-4c30-8129-a94c5eafed93/documents/IUC5-6984d33f-5aae-465e-98f6-d970b0fa26aa_97c7ab0f-e4b0-4638-b352-57fd4b88ccaa.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "C18-C50 branched, cyclic and linear hydrocarbons - Distillates",848301-69-9,"- Acute oral toxicity: The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 5000 mg/kg bodyweight.- Acute inhalation and dermal toxicity: Based on lack of skin irritation and systemic effects in a skin irritation study the substance is not considered to acute harmful in contact with skin. Moreover, the substance is unlikely to form aerosols or particles of inhalable size. Therefore it is considered justifiable not to conduct these studies. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4231c860-f422-4c30-8129-a94c5eafed93/documents/IUC5-4d56e6a4-3dc9-4857-981f-bb45d711d0cd_97c7ab0f-e4b0-4638-b352-57fd4b88ccaa.html,,,,,, "C18-C50 branched, cyclic and linear hydrocarbons - Distillates",848301-69-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4231c860-f422-4c30-8129-a94c5eafed93/documents/IUC5-4d56e6a4-3dc9-4857-981f-bb45d711d0cd_97c7ab0f-e4b0-4638-b352-57fd4b88ccaa.html,,oral,LD50,"5,000 mg/kg bw",, "Distillates (petroleum), chemically neutralized light",64742-31-0,"A number of subacute and subchronic studies with kerosines and jet fuels are available (OECD 410, 412, 413, and other non-guideline protocols). The repeated inhalation and oral studies of kerosine in rats produced no consistent toxicological effects other than changes in male rat kidneys that are not considered relevant to humans. The NOAEC for inhalation exposure is greater than or equal to 1000 mg/m3 (vapour).  The systemic dermal NOAEL is greater than or equal to 495 mg/kg bw/day, based on a well conducted 90-day study in rats.  The NOAEL for systemic effects of oral exposure is 750 mg/kg/day. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b850d73-a99d-4ea3-8134-1f28a318e00b/documents/89277e09-fd6a-4778-85aa-41521a1ff043_4fcfb4e9-572d-4ff1-ae8c-b5eda4409cfe.html,,,,,, "Distillates (petroleum), chemically neutralized light",64742-31-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b850d73-a99d-4ea3-8134-1f28a318e00b/documents/89277e09-fd6a-4778-85aa-41521a1ff043_4fcfb4e9-572d-4ff1-ae8c-b5eda4409cfe.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Distillates (petroleum), chemically neutralized light",64742-31-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b850d73-a99d-4ea3-8134-1f28a318e00b/documents/89277e09-fd6a-4778-85aa-41521a1ff043_4fcfb4e9-572d-4ff1-ae8c-b5eda4409cfe.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,495 mg/kg bw/day,,rat "Distillates (petroleum), chemically neutralized light",64742-31-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b850d73-a99d-4ea3-8134-1f28a318e00b/documents/89277e09-fd6a-4778-85aa-41521a1ff043_4fcfb4e9-572d-4ff1-ae8c-b5eda4409cfe.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat "Distillates (petroleum), chemically neutralized light",64742-31-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b850d73-a99d-4ea3-8134-1f28a318e00b/documents/89277e09-fd6a-4778-85aa-41521a1ff043_4fcfb4e9-572d-4ff1-ae8c-b5eda4409cfe.html,Repeated dose toxicity – local effects,dermal,LOAEL,1 mg/cm2,adverse effect observed,rat "Distillates (petroleum), chemically neutralized light",64742-31-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b850d73-a99d-4ea3-8134-1f28a318e00b/documents/89277e09-fd6a-4778-85aa-41521a1ff043_4fcfb4e9-572d-4ff1-ae8c-b5eda4409cfe.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,000 mg/m3",no adverse effect observed,rat "Distillates (petroleum), chemically neutralized light",64742-31-0,"Kerosines are of low acute toxicity with mortality rarely reported even at very high exposures in experimental animal studies conducted by oral (similar to OECD 420), dermal (similar to OECD 402), and inhalation (similar to OECD 403) exposure.  • The oral LD50 was > 5000 mg/kg bw in male and female rats for kerosine.• The dermal LD50 was > 2000 mg/kg/bw in male and female rabbits for kerosine.• The inhalation LC50 was > 5.28 mg/L vapour in male and female rats for kerosine. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b850d73-a99d-4ea3-8134-1f28a318e00b/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_4fcfb4e9-572d-4ff1-ae8c-b5eda4409cfe.html,,,,,, "Distillates (petroleum), chemically neutralized light",64742-31-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b850d73-a99d-4ea3-8134-1f28a318e00b/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_4fcfb4e9-572d-4ff1-ae8c-b5eda4409cfe.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), chemically neutralized light",64742-31-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b850d73-a99d-4ea3-8134-1f28a318e00b/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_4fcfb4e9-572d-4ff1-ae8c-b5eda4409cfe.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), chemically neutralized light",64742-31-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b850d73-a99d-4ea3-8134-1f28a318e00b/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_4fcfb4e9-572d-4ff1-ae8c-b5eda4409cfe.html,,inhalation,LC50,"5,280 mg/m3",no adverse effect observed, "Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C10-12 fraction",68477-40-7,"The limited repeat dose toxicity data on specific streams identified for this category (oral toxicity studies for CAS 68477-54-3 [Low Dicyclopentadiene Resin Oil] and CAS 48478-10-4 [Dicyclopentadiene/Codimer Concentrate] provided no evidence of significant target organ toxicity. However, there are substantial data on the repeated dose toxicity of a number of specific components benzene, toluene, styrene and ethylbenzene present in some streams which demonstrate significant target organ toxicity. Classification witll be required for streams that contain concentrations greater than or equal to 1% (benzene) or 10% (toluene). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bbc8792e-d1a2-487c-900e-eecda7984ec7/documents/IUC5-8f0a2179-4a82-413a-b0f1-e8e77252a5c5_36190757-8560-4f6f-88c9-eee244a0ddf1.html,,,,,, "Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C10-12 fraction",68477-40-7,"Available data for 4 specific streams within this category Cracked distillate [CAS 68477-40-7], C9 Resinfeed [CAS 68477-54-3], E000144700 [CAS 68516-20-1] and C9 Produkt [CAS 94733-07-0] and on specific components (benzene, toluene, 1,3-butadiene, naphthalene and isoprene) that are present in some streams indicate that acute toxicity is generally expected to be low. Resin Oil and Cyclic Dienes do not pose an acute hazard following skin contact (dermal LD50 > 2000 mg/kg). Two streams (E000044012 [CAS 68478-10-4], E000044146 [CAS 68478-10-4]) were considered to be hazardous following acute inhalation exposures. Streams containing a high proportion of naphthalene (≥25%) are expected to be hazardous following oral exposures. Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans and is labelled R22. Styrene is hazardous following acute inhalation exposure and classification will be required for streams containing ≥12.5%. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and labelling (R67) will be required for streams containing ≥20% toluene. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbc8792e-d1a2-487c-900e-eecda7984ec7/documents/IUC5-bb8f61e9-128d-46f0-8ed7-bb0700ea62b2_36190757-8560-4f6f-88c9-eee244a0ddf1.html,,,,,, "Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C8-10 fraction",68477-39-4,"There are data for repeat exposure to one low benzene naphtha streams representing the inhalation route of exposure and a related stream representing the dermal route. These do not indicate any specific target organ toxicity which would warrant classification. However, there are substantial data on the repeated dose toxicity of toluene which demonstrates significant target organ toxicity and, when present at concentrations greater than or equal to 10%, this component substance will influence classification due to mammalian toxicity effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f814476c-2d71-4822-8a8d-441ef7324407/documents/a7f018ae-d769-4637-b4fa-9742962b2abb_8f3c663a-bb39-458c-b0d4-d7c67dcfb87f.html,,,,,, "Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C8-10 fraction",68477-39-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f814476c-2d71-4822-8a8d-441ef7324407/documents/a7f018ae-d769-4637-b4fa-9742962b2abb_8f3c663a-bb39-458c-b0d4-d7c67dcfb87f.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rabbit "Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C8-10 fraction",68477-39-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f814476c-2d71-4822-8a8d-441ef7324407/documents/a7f018ae-d769-4637-b4fa-9742962b2abb_8f3c663a-bb39-458c-b0d4-d7c67dcfb87f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,625 mg/kg bw/day,,rat "Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C8-10 fraction",68477-39-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f814476c-2d71-4822-8a8d-441ef7324407/documents/a7f018ae-d769-4637-b4fa-9742962b2abb_8f3c663a-bb39-458c-b0d4-d7c67dcfb87f.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,131 mg/m3",,rat "Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C8-10 fraction",68477-39-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f814476c-2d71-4822-8a8d-441ef7324407/documents/a7f018ae-d769-4637-b4fa-9742962b2abb_8f3c663a-bb39-458c-b0d4-d7c67dcfb87f.html,Repeated dose toxicity – local effects,dermal,LOAEL,200 mg/cm2,adverse effect observed,rabbit "Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C8-10 fraction",68477-39-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f814476c-2d71-4822-8a8d-441ef7324407/documents/a7f018ae-d769-4637-b4fa-9742962b2abb_8f3c663a-bb39-458c-b0d4-d7c67dcfb87f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,131 mg/m3",adverse effect observed,rat "Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C8-10 fraction",68477-39-4,"Available non-human data for CAS 68516-20-1, a low benzene naphtha stream, and data on the specific component toluene, indicate that acute toxicity is expected to be low. Low benzene naphtha streams do not pose an acute hazard following ingestion (oral LD50 > 2000 mg/kg bw) or skin contact (dermal LD50 > 2000 mg/kg). The acute inhalation 4 hour LC50 is greater than saturated vapour pressure for the stream considered and > 20 mg/L for toluene. However following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and labelling will be required as low benzene naphtha streams contain up to 50% toluene. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f814476c-2d71-4822-8a8d-441ef7324407/documents/IUC5-978da215-cc20-4b79-9b82-547be5c9bcb5_8f3c663a-bb39-458c-b0d4-d7c67dcfb87f.html,,,,,, "Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C8-10 fraction",68477-39-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f814476c-2d71-4822-8a8d-441ef7324407/documents/IUC5-978da215-cc20-4b79-9b82-547be5c9bcb5_8f3c663a-bb39-458c-b0d4-d7c67dcfb87f.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C8-10 fraction",68477-39-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f814476c-2d71-4822-8a8d-441ef7324407/documents/IUC5-978da215-cc20-4b79-9b82-547be5c9bcb5_8f3c663a-bb39-458c-b0d4-d7c67dcfb87f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), cracked stripped steam-cracked petroleum distillates, C8-10 fraction",68477-39-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f814476c-2d71-4822-8a8d-441ef7324407/documents/IUC5-978da215-cc20-4b79-9b82-547be5c9bcb5_8f3c663a-bb39-458c-b0d4-d7c67dcfb87f.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, "Distillates (petroleum), cracked, ethylene manuf. by-product, C9-10 fraction",94733-07-0," The limited repeat dose toxicity data on specific streams identified for this category (oral toxicity studies for CAS 68477-54-3 [Low Dicyclopentadiene Resin Oil] and CAS 648478-10-4 [Dicyclopentadiene/Codimer Concentrate] provided no evidence of significant target organ toxicity. However, there are substantial data on the repeated dose toxicity of a number of specific constituents benzene, toluene, styrene and ethylbenzene present in some streams which demonstrate significant target organ toxicity. Classification will be required for streams that contain concentrations greater than or equal to 1% (benzene) or 10% (toluene). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00f57cb6-770b-49d9-856b-0cfcee07ada1/documents/90cf25de-7056-4043-883f-afcdf26aac53_fba5be7d-8401-4d2f-9eb0-dec0536e4026.html,,,,,, "Distillates (petroleum), cracked, ethylene manuf. by-product, C9-10 fraction",94733-07-0," Available data for 3 specific streams within this category: C9 Resinfeed [CAS 68477-54-3]; E000144700 [CAS 68516-20-1]; and C9 Produkt [CAS 94733-07-0] and on specific constituents (benzene, toluene, n-Hexane) that are present in some streams indicate that acute toxicity is generally expected to be low. Resin Oil and Cyclic Dienes do not pose an acute hazard following skin contact (dermal LD50 > 2000 mg/Kg). Two streams (E000044012 [CAS 68478-10-4], E000044146 [CAS 68478-10-4]) and the constituent dicyclopentadiene are considered to be hazardous following acute inhalation exposures. Streams containing a high proportion (≥ 25%) of dicyclopentadiene or naphthalene are expected to be hazardous following oral exposures. Styrene is hazardous following acute inhalation exposure and classification will be required for streams containing ≥ 25%. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and labelling will be required for streams containing ≥ 20% toluene. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00f57cb6-770b-49d9-856b-0cfcee07ada1/documents/54b66a95-cb8a-43b2-be0b-245e0fadc96f_fba5be7d-8401-4d2f-9eb0-dec0536e4026.html,,,,,, "Distillates (petroleum), full-range straight-run middle",68814-87-9," In sub-acute oral studies on CAS 68814-87-9, 64741-43-1 and CAS 64741-44-2 (conducted according to OECD TG 422), there were no treatment-related adverse effects on systemic toxicity parameters up to and including the highest dose tested (750 mg/kg/day) and accordingly the NOAELs were set at this level. In a sub-acute oral study on CAS 68915-96-8 (conducted according to OECD TG 422) at doses of 100, 300, 750 and 1000 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 100 mg/kg/day for males and 300 mg/kg/day for females.  This is the substance in the category provisionally selected for higher tier testing in the test proposals already submitted. A key 'read across' 90-day dermal study in rats was identified in which vacuum tower overheads was applied to the shaved skin of rats, 5 days a weeks for 90-days. The NOAEL was 30 mg/kg/day, based on findings in liver, thymus and blood. A 28 day repeated dose toxicity studies in rabbits was identified for dermal exposure, plus a supporting 28 day dermal study in rats.  There was one key read-across 90-day repeated dose toxicity study (OECD 413) for inhalation. For the read-across 90-day inhalation study, a NOAEC of 0.88 mg/L for local effects on the lung (increased relative wet weight in the absence of histopathological change) was established in rats expose to aerosol.  A NOAEC of greater than or equal to 1.71 mg/L is established for systemic effects, based on no significant findings at this level. For the 28-day dermal study, a LOAEL of 200 mg/kg/day was established based on local irritation. No NOEL was determined for local irritation.  The NOAEL for systemic effects in rabbits following repeated dermal exposure was greater than or equal to 2000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e546f076-4562-4984-9bc2-bd50b6f11c03/documents/c244fb29-9c5d-4dcc-9137-c575a1def977_049756e4-0117-4f0e-ba2d-4183d87971cc.html,,,,,, "Distillates (petroleum), full-range straight-run middle",68814-87-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e546f076-4562-4984-9bc2-bd50b6f11c03/documents/c244fb29-9c5d-4dcc-9137-c575a1def977_049756e4-0117-4f0e-ba2d-4183d87971cc.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,30 mg/kg bw/day,,rat "Distillates (petroleum), full-range straight-run middle",68814-87-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e546f076-4562-4984-9bc2-bd50b6f11c03/documents/c244fb29-9c5d-4dcc-9137-c575a1def977_049756e4-0117-4f0e-ba2d-4183d87971cc.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Distillates (petroleum), full-range straight-run middle",68814-87-9,"Key acute oral (OECD 401), dermal (OECD 402), and inhalation (OECD 403) studies were identified for straight run gas oils.  LD50 and LC50 values were as follows:• The oral LD50 was > 5000 mg/kg bw in male and female rats.• The dermal LD50 was > 2000 mg/kg bw in male and female rabbits.• The LC50 was > 2.53 mg/L in male and female rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e546f076-4562-4984-9bc2-bd50b6f11c03/documents/09fd26d0-b3c1-4ae3-8630-9fa8f878316a_049756e4-0117-4f0e-ba2d-4183d87971cc.html,,,,,, "Distillates (petroleum), full-range straight-run middle",68814-87-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e546f076-4562-4984-9bc2-bd50b6f11c03/documents/09fd26d0-b3c1-4ae3-8630-9fa8f878316a_049756e4-0117-4f0e-ba2d-4183d87971cc.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), full-range straight-run middle",68814-87-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e546f076-4562-4984-9bc2-bd50b6f11c03/documents/09fd26d0-b3c1-4ae3-8630-9fa8f878316a_049756e4-0117-4f0e-ba2d-4183d87971cc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), full-range straight-run middle",68814-87-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e546f076-4562-4984-9bc2-bd50b6f11c03/documents/09fd26d0-b3c1-4ae3-8630-9fa8f878316a_049756e4-0117-4f0e-ba2d-4183d87971cc.html,,inhalation,LC50,"2,530 mg/m3",adverse effect observed, "Distillates (petroleum), heavy straight-run",68915-96-8," In sub-acute oral studies on CAS 68814-87-9, 64741-43-1 and CAS 64741-44-2 (conducted according to OECD TG 422), there were no treatment-related adverse effects on systemic toxicity parameters up to and including the highest dose tested (750 mg/kg/day) and accordingly the NOAELs were set at this level. In a sub-acute oral study on CAS 68915-96-8 (conducted according to OECD TG 422) at doses of 100, 300, 750 and 1000 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 100 mg/kg/day for males and 300 mg/kg/day for females.  This is the substance in the category provisionally selected for higher tier testing in the test proposals already submitted. A key 'read across' 90-day dermal study in rats was identified in which vacuum tower overheads was applied to the shaved skin of rats, 5 days a weeks for 90-days. The NOAEL was 30 mg/kg/day, based on findings in liver, thymus and blood. A 28 day repeated dose toxicity studies in rabbits was identified for dermal exposure, plus a supporting 28 day dermal study in rats.  There was one key read-across 90-day repeated dose toxicity study (OECD 413) for inhalation. For the read-across 90-day inhalation study, a NOAEC of 0.88 mg/L for local effects on the lung (increased relative wet weight in the absence of histopathological change) was established in rats expose to aerosol.  A NOAEC of greater than or equal to 1.71 mg/L is established for systemic effects, based on no significant findings at this level. For the 28-day dermal study, a LOAEL of 200 mg/kg/day was established based on local irritation. No NOEL was determined for local irritation.  The NOAEL for systemic effects in rabbits following repeated dermal exposure was greater than or equal to 2000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa419403-0fa1-4789-8d65-f575118ab459/documents/c244fb29-9c5d-4dcc-9137-c575a1def977_1c5eed9f-bb72-498f-86c0-8ca7b1f4e61b.html,,,,,, "Distillates (petroleum), heavy straight-run",68915-96-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa419403-0fa1-4789-8d65-f575118ab459/documents/c244fb29-9c5d-4dcc-9137-c575a1def977_1c5eed9f-bb72-498f-86c0-8ca7b1f4e61b.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,30 mg/kg bw/day,,rat "Distillates (petroleum), heavy straight-run",68915-96-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa419403-0fa1-4789-8d65-f575118ab459/documents/c244fb29-9c5d-4dcc-9137-c575a1def977_1c5eed9f-bb72-498f-86c0-8ca7b1f4e61b.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Distillates (petroleum), heavy straight-run",68915-96-8,"Key acute oral (OECD 401), dermal (OECD 402), and inhalation (OECD 403) studies were identified for straight run gas oils.  LD50 and LC50 values were as follows:• The oral LD50 was > 5000 mg/kg bw in male and female rats.• The dermal LD50 was > 2000 mg/kg bw in male and female rabbits.• The LC50 was > 2.53 mg/L in male and female rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa419403-0fa1-4789-8d65-f575118ab459/documents/09fd26d0-b3c1-4ae3-8630-9fa8f878316a_1c5eed9f-bb72-498f-86c0-8ca7b1f4e61b.html,,,,,, "Distillates (petroleum), heavy straight-run",68915-96-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa419403-0fa1-4789-8d65-f575118ab459/documents/09fd26d0-b3c1-4ae3-8630-9fa8f878316a_1c5eed9f-bb72-498f-86c0-8ca7b1f4e61b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), heavy straight-run",68915-96-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa419403-0fa1-4789-8d65-f575118ab459/documents/09fd26d0-b3c1-4ae3-8630-9fa8f878316a_1c5eed9f-bb72-498f-86c0-8ca7b1f4e61b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), heavy straight-run",68915-96-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa419403-0fa1-4789-8d65-f575118ab459/documents/09fd26d0-b3c1-4ae3-8630-9fa8f878316a_1c5eed9f-bb72-498f-86c0-8ca7b1f4e61b.html,,inhalation,LC50,"2,530 mg/m3",adverse effect observed, "Distillates (petroleum), hydrotreated light catalytic cracked",68921-07-3,"No repeat dose toxicity studies have been identified for cracked gas oils, following inhalation or oral exposure. The sub-chronic inhalation study of diesel fuel (OECD 413, a read-across study from VGO/HGO/Distillate Fuels) resulted in a conservative sub-chronic NOAEC of 0.88 mg/L determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of ≥1.71 mg/L was established for systemic effects, based on no significant findings at this level.In a 28-day sub-acute study (OECD 410), dermal exposure to a light catalytically cracked distillate resulted in limited systemic changes and a NOAEL of 500 mg/kg body weight/day.  In a 90-day sub-chronic study (OECD 411), dermal exposure to light catalytically cracked distillate resulted in a systemic NOAEL of 25 mg/kg body weight/day for males, and 125 mg/kg body weight/day for females, based upon reductions in thymus weight.  In another 90-day sub-chronic study (OECD 411), dermal exposure to coker light gas oil resulted in a systemic LOAEL of 30 mg/kg body weight/day for males and females, based upon clinical signs and irritation noted at all doses. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/44011608-c91f-481e-a51b-8170d17e59bb/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_2607e9d7-459a-4c9b-aa26-983e8389931b.html,,,,,, "Distillates (petroleum), hydrotreated light catalytic cracked",68921-07-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/44011608-c91f-481e-a51b-8170d17e59bb/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_2607e9d7-459a-4c9b-aa26-983e8389931b.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), hydrotreated light catalytic cracked",68921-07-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/44011608-c91f-481e-a51b-8170d17e59bb/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_2607e9d7-459a-4c9b-aa26-983e8389931b.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Distillates (petroleum), hydrotreated light catalytic cracked",68921-07-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/44011608-c91f-481e-a51b-8170d17e59bb/documents/fcd1aee2-941a-4ace-9495-f4b66830f59c_2607e9d7-459a-4c9b-aa26-983e8389931b.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Distillates (petroleum), hydrotreated light catalytic cracked",68921-07-3,"Acute Oral Toxicity:Acute oral toxicity of cracked gas oils was evaluated in male and female rats by a single oral gavage administration of a dose ranging from 2050 to 6250 mg/kg body weight.  Based on mortality and toxicity findings, an oral LD50 of 4660 mg/kg body weight and 3200 mg/kg body weight were reported for males and females, respectively.  Acute Inhalation Toxicity:Acute inhalation toxicity of cracked gas oils in rats was evaluated via whole-body exposure to test material at various measured concentrations for 4 hours.  The acute inhalation LC50 was 4.65 mg/L in males and females. Acute Dermal Toxicity:Acute dermal toxicity of cracked gas oils was evaluated in male and female rabbits at a single dose of 2000 mg/kg body weight.  Based on a lack of adverse systemic effects or mortality, the acute dermal LD50 for light catalytically cracked distillate was >2000 mg/kg body weight.   ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44011608-c91f-481e-a51b-8170d17e59bb/documents/61f4e539-9411-462c-acca-769cdd71de1b_2607e9d7-459a-4c9b-aa26-983e8389931b.html,,,,,, "Distillates (petroleum), hydrotreated light catalytic cracked",68921-07-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44011608-c91f-481e-a51b-8170d17e59bb/documents/61f4e539-9411-462c-acca-769cdd71de1b_2607e9d7-459a-4c9b-aa26-983e8389931b.html,,oral,LD50,"3,200 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated light catalytic cracked",68921-07-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44011608-c91f-481e-a51b-8170d17e59bb/documents/61f4e539-9411-462c-acca-769cdd71de1b_2607e9d7-459a-4c9b-aa26-983e8389931b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), hydrotreated light catalytic cracked",68921-07-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44011608-c91f-481e-a51b-8170d17e59bb/documents/61f4e539-9411-462c-acca-769cdd71de1b_2607e9d7-459a-4c9b-aa26-983e8389931b.html,,inhalation,LC50,"4,650 mg/m3",adverse effect observed, "Distillates (petroleum), steam-cracked",64742-91-2," Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene / n-hexane - when present at 10%). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b26964a2-e4fa-4ea2-a328-6cc75d721c28/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_bc80fb6f-b703-4961-8d41-83c6dadeea9b.html,,,,,, "Distillates (petroleum), steam-cracked",64742-91-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b26964a2-e4fa-4ea2-a328-6cc75d721c28/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_bc80fb6f-b703-4961-8d41-83c6dadeea9b.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), steam-cracked",64742-91-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b26964a2-e4fa-4ea2-a328-6cc75d721c28/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_bc80fb6f-b703-4961-8d41-83c6dadeea9b.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Distillates (petroleum), steam-cracked",64742-91-2," Available data for one stream within this category (CAS 68516-20-1) and data on specific constituents (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b26964a2-e4fa-4ea2-a328-6cc75d721c28/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_bc80fb6f-b703-4961-8d41-83c6dadeea9b.html,,,,,, "Distillates (petroleum), steam-cracked",64742-91-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b26964a2-e4fa-4ea2-a328-6cc75d721c28/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_bc80fb6f-b703-4961-8d41-83c6dadeea9b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), steam-cracked",64742-91-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b26964a2-e4fa-4ea2-a328-6cc75d721c28/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_bc80fb6f-b703-4961-8d41-83c6dadeea9b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), steam-cracked",64742-91-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b26964a2-e4fa-4ea2-a328-6cc75d721c28/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_bc80fb6f-b703-4961-8d41-83c6dadeea9b.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, "Distillates (petroleum), steam-cracked, C8-12 fraction",68477-54-3,"After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and in humans. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f64f2630-9e05-4997-9854-646ddb0780e8/documents/0a65e697-ca75-4710-87c1-abe636e0b74a_6e0ea15f-e61e-46c6-b9c8-4475b7181e38.html,,,,,, "Distillates (petroleum), steam-cracked, C8-12 fraction",68477-54-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f64f2630-9e05-4997-9854-646ddb0780e8/documents/0a65e697-ca75-4710-87c1-abe636e0b74a_6e0ea15f-e61e-46c6-b9c8-4475b7181e38.html,Chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Distillates (petroleum), steam-cracked, C8-12 fraction",68477-54-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f64f2630-9e05-4997-9854-646ddb0780e8/documents/0a65e697-ca75-4710-87c1-abe636e0b74a_6e0ea15f-e61e-46c6-b9c8-4475b7181e38.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human (epidemiological findings) "Distillates (petroleum), steam-cracked, C8-12 fraction",68477-54-3," Benzene does not pose an acute hazard following ingestion (oral LD50 > 2000 mg/kg), skin contact (dermal LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f64f2630-9e05-4997-9854-646ddb0780e8/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_6e0ea15f-e61e-46c6-b9c8-4475b7181e38.html,,,,,, "Distillates (petroleum), steam-cracked, C8-12 fraction",68477-54-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f64f2630-9e05-4997-9854-646ddb0780e8/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_6e0ea15f-e61e-46c6-b9c8-4475b7181e38.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), steam-cracked, C8-12 fraction",68477-54-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f64f2630-9e05-4997-9854-646ddb0780e8/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_6e0ea15f-e61e-46c6-b9c8-4475b7181e38.html,,dermal,LD50,"8,260 mg/kg bw",no adverse effect observed, "Distillates (petroleum), steam-cracked, C8-12 fraction",68477-54-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f64f2630-9e05-4997-9854-646ddb0780e8/documents/ab4531e2-fe5b-4a8b-9504-a398c680ade2_6e0ea15f-e61e-46c6-b9c8-4475b7181e38.html,,inhalation,LC50,"43,767 mg/m3",no adverse effect observed, "Distillates (petroleum), straight-run middle",64741-44-2," In sub-acute oral studies on CAS 68814-87-9, 64741-43-1 and CAS 64741-44-2 (conducted according to OECD TG 422), there were no treatment-related adverse effects on systemic toxicity parameters up to and including the highest dose tested (750 mg/kg/day) and accordingly the NOAELs were set at this level. In a sub-acute oral study on CAS 68915-96-8 (conducted according to OECD TG 422) at doses of 100, 300, 750 and 1000 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 100 mg/kg/day for males and 300 mg/kg/day for females.  This is the substance in the category provisionally selected for higher tier testing in the test proposals already submitted. A key 'read across' 90-day dermal study in rats was identified in which vacuum tower overheads was applied to the shaved skin of rats, 5 days a weeks for 90-days. The NOAEL was 30 mg/kg/day, based on findings in liver, thymus and blood. A 28 day repeated dose toxicity studies in rabbits was identified for dermal exposure, plus a supporting 28 day dermal study in rats.  There was one key read-across 90-day repeated dose toxicity study (OECD 413) for inhalation. For the read-across 90-day inhalation study, a NOAEC of 0.88 mg/L for local effects on the lung (increased relative wet weight in the absence of histopathological change) was established in rats expose to aerosol.  A NOAEC of greater than or equal to 1.71 mg/L is established for systemic effects, based on no significant findings at this level. For the 28-day dermal study, a LOAEL of 200 mg/kg/day was established based on local irritation. No NOEL was determined for local irritation.  The NOAEL for systemic effects in rabbits following repeated dermal exposure was greater than or equal to 2000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3be9bc32-c113-46c1-aeca-ad543efa52cf/documents/c244fb29-9c5d-4dcc-9137-c575a1def977_15e5493d-8ab9-44fd-94fa-44853dd5d8cc.html,,,,,, "Distillates (petroleum), straight-run middle",64741-44-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3be9bc32-c113-46c1-aeca-ad543efa52cf/documents/c244fb29-9c5d-4dcc-9137-c575a1def977_15e5493d-8ab9-44fd-94fa-44853dd5d8cc.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,30 mg/kg bw/day,,rat "Distillates (petroleum), straight-run middle",64741-44-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3be9bc32-c113-46c1-aeca-ad543efa52cf/documents/c244fb29-9c5d-4dcc-9137-c575a1def977_15e5493d-8ab9-44fd-94fa-44853dd5d8cc.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Distillates (petroleum), straight-run middle",64741-44-2,"Key acute oral (OECD 401), dermal (OECD 402), and inhalation (OECD 403) studies were identified for straight run gas oils.  LD50 and LC50 values were as follows:• The oral LD50 was > 5000 mg/kg bw in male and female rats.• The dermal LD50 was > 2000 mg/kg bw in male and female rabbits.• The LC50 was > 2.53 mg/L in male and female rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3be9bc32-c113-46c1-aeca-ad543efa52cf/documents/09fd26d0-b3c1-4ae3-8630-9fa8f878316a_15e5493d-8ab9-44fd-94fa-44853dd5d8cc.html,,,,,, "Distillates (petroleum), straight-run middle",64741-44-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3be9bc32-c113-46c1-aeca-ad543efa52cf/documents/09fd26d0-b3c1-4ae3-8630-9fa8f878316a_15e5493d-8ab9-44fd-94fa-44853dd5d8cc.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), straight-run middle",64741-44-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3be9bc32-c113-46c1-aeca-ad543efa52cf/documents/09fd26d0-b3c1-4ae3-8630-9fa8f878316a_15e5493d-8ab9-44fd-94fa-44853dd5d8cc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Distillates (petroleum), straight-run middle",64741-44-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3be9bc32-c113-46c1-aeca-ad543efa52cf/documents/09fd26d0-b3c1-4ae3-8630-9fa8f878316a_15e5493d-8ab9-44fd-94fa-44853dd5d8cc.html,,inhalation,LC50,"2,530 mg/m3",adverse effect observed, Disulphur dichloride,10025-67-9,Repeated dose toxicity (oral): waiving (exposure considerations)Repeated dose toxicity (dermal): waiving (exposure considerations)Repeated dose Toxicity (inhalation) waiving (exposure considerations) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8895c098-e97d-42f8-9a42-e96aeb44b1c6/documents/IUC5-7c9601a2-30a6-4de3-9aa3-1687b66a1fe3_dcebe4cc-a9df-4c98-86bc-5df75b763b30.html,,,,,, Disulphur dichloride,10025-67-9,"Acute oral toxicityLoeser E (1984): LD50 = 78 µL/kg body weight (132 mg/kg bw; slope = 3.28), for male and female rats. Acute inhalative toxicity Pauluhn J. (1987): LC50 = 2500 mg/m³ air (LC50=2.5 mg/L/4h). The vapour NOEL was calculated to be 0.184 mg/L/4 hRats showed unspecific symptoms of poisoning with breathing difficulties and irritation of the visible mucous membrane. Acute dermal toxicityAccording to EC No 1907/2006 (REACH) Annex VIII column 2, a dermal study does not need to be conducted because substance is classified as corrosive according to 67/548/EEC Annex 1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8895c098-e97d-42f8-9a42-e96aeb44b1c6/documents/IUC5-6816707e-1b87-4965-b997-d0a36afaea46_dcebe4cc-a9df-4c98-86bc-5df75b763b30.html,,,,,, Disulphur dichloride,10025-67-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8895c098-e97d-42f8-9a42-e96aeb44b1c6/documents/IUC5-6816707e-1b87-4965-b997-d0a36afaea46_dcebe4cc-a9df-4c98-86bc-5df75b763b30.html,,oral,LD50,132 mg/kg bw,adverse effect observed, Disulphur dichloride,10025-67-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8895c098-e97d-42f8-9a42-e96aeb44b1c6/documents/IUC5-6816707e-1b87-4965-b997-d0a36afaea46_dcebe4cc-a9df-4c98-86bc-5df75b763b30.html,,inhalation,LC50,"2,500 mg/m3",adverse effect observed, Ditantalum pentaoxide,1314-61-0," In a GLP guideline study according to OECD 408, only minimal effects on clinical chemistry parameters were observd, which were not considered toxicologically relevant.Therefore, the NOAEL was considered to be 1000 mg/kg bw/day, i.e. the highest dose tested. In addition, a GLP guideline study according to OECD 422 was conducted with tantalum pentachloride in a read across approach. No adverse effects were observed after oral administration of the source substance tantalum pentachloride in male and female Wistar rats at the highest tested dose of 1000 mg/kg bw/day. Based on the results, the NOAEL can be considered to be 1000 mg/kg bw/day. According to these study results ditantalum pentoxide does not have any adverse effects on rats after oral exposure up to the highest doses tested. Supporting data was obtained from a non-GLP, non-guideline subacute repeated inhalation toxicity study with tantalum pentoxide. No specific changes of the lung tissues and no systemic toxicity was observed at the single concentration of 150 mg/m³. Nevertheless, in some animals haemorrhagic infarcts caused by prolonged dust application were observed. The lesions were attributed to particle effects and are not considered substance specific. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fbb4fb6-9c5d-4a85-9345-a50b76eae157/documents/0c3393a0-ee1a-4c89-aa15-a9664913bd20_aed39b00-5f5c-4b99-a2eb-b30a57ff40ac.html,,,,,, Ditantalum pentaoxide,1314-61-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fbb4fb6-9c5d-4a85-9345-a50b76eae157/documents/0c3393a0-ee1a-4c89-aa15-a9664913bd20_aed39b00-5f5c-4b99-a2eb-b30a57ff40ac.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,150 mg/m3,,rat Ditantalum pentaoxide,1314-61-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fbb4fb6-9c5d-4a85-9345-a50b76eae157/documents/0c3393a0-ee1a-4c89-aa15-a9664913bd20_aed39b00-5f5c-4b99-a2eb-b30a57ff40ac.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Ditantalum pentaoxide,1314-61-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fbb4fb6-9c5d-4a85-9345-a50b76eae157/documents/0c3393a0-ee1a-4c89-aa15-a9664913bd20_aed39b00-5f5c-4b99-a2eb-b30a57ff40ac.html,Repeated dose toxicity – local effects,inhalation,NOAEC,150 mg/m3,no adverse effect observed,rat Ditantalum pentaoxide,1314-61-0," ACUTE ORAL TOXICITY The oral toxicity of ditantalum pentaoxide has been recorded in key literature to be LD0 ≥ 8000 mg/kg in rats (Cochran 1950). ACUTE INHALATION TOXICITY The acute inhalation toxicity of ditantalum pentaoxide was determined to be LD0 > 3.89 mg/l  in the key study Wilcox (2001), according to the following standardised guidelines: OECD 403, EPA OPPTS 870.1300, EEC (Annex II, point 5.2.3) and J-MAFF. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fbb4fb6-9c5d-4a85-9345-a50b76eae157/documents/57bd2de6-9452-416f-ae39-b77f4086cdd3_aed39b00-5f5c-4b99-a2eb-b30a57ff40ac.html,,,,,, "Di-tert-butyl 1,1,4,4-tetramethylbut-2-yn-1,4-ylene diperoxide",1068-27-5," The oral administration of Di-Tert-Butyl 1,1,4,4-Tetramethyl Tetramethylene Diperoxide (read-across substance), CAS 78-63-7 to rats by gavage, for 90 days, at dose levels of 15, 50 and 150 mg/kgbw/day, did not result in any toxicologically significant adverse effects. The ‘No Observed Adverse Effect Level’ (NOAEL) was, therefore, considered to be 150 mg/kgbw/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Apparently well conducted GLP study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3322a2a-c157-4956-b69d-d779def6e6df/documents/9985cbba-4f24-4cb3-bc87-f3abb9f339c0_87971a92-af27-4264-86ad-4a52acdbab43.html,,,,,, "Di-tert-butyl 1,1,4,4-tetramethylbut-2-yn-1,4-ylene diperoxide",1068-27-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3322a2a-c157-4956-b69d-d779def6e6df/documents/9985cbba-4f24-4cb3-bc87-f3abb9f339c0_87971a92-af27-4264-86ad-4a52acdbab43.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Di-tert-butyl 1,1,4,4-tetramethylbut-2-yn-1,4-ylene diperoxide",1068-27-5," In an acute oral toxicity study with the test substance (AKZO Nobel 2001, 317712), an LD50 >2000 mg/kg was observed. In an acute dermal toxicity study with the test substance (AKZO Nobel 2003, 366301), an LD50 >2000 mg/kg was observed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3322a2a-c157-4956-b69d-d779def6e6df/documents/985f1e74-ac7a-4ef2-8deb-4b5e11cc6963_87971a92-af27-4264-86ad-4a52acdbab43.html,,,,,, "Di-tert-butyl 1,1,4,4-tetramethylbut-2-yn-1,4-ylene diperoxide",1068-27-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3322a2a-c157-4956-b69d-d779def6e6df/documents/985f1e74-ac7a-4ef2-8deb-4b5e11cc6963_87971a92-af27-4264-86ad-4a52acdbab43.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Di-tert-butyl 1,1,4,4-tetramethylbut-2-yn-1,4-ylene diperoxide",1068-27-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3322a2a-c157-4956-b69d-d779def6e6df/documents/985f1e74-ac7a-4ef2-8deb-4b5e11cc6963_87971a92-af27-4264-86ad-4a52acdbab43.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Di-tert-butyl 1,1,4,4-tetramethyltetramethylene diperoxide",78-63-7," The oral administration of Di-Tert-Butyl 1,1,4,4-Tetramethyl Tetramethylene Diperoxide, CAS# 78-63-7 to rats by gavage, for 90 days, at dose levels of 15, 50 and 150 mg/kg bw/day, did not result in any toxicologically significant adverse effects. The ‘No Observed Adverse Effect Level’ (NOAEL) was therefore considered to be 150 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6fc32392-ad92-450a-a9c3-8237f9ee5f33/documents/IUC5-6b37e836-39d6-4056-84bf-80724a44544f_0263ab17-3fd0-4c90-9a03-dc2fa8341dfe.html,,,,,, "Di-tert-butyl 1,1,4,4-tetramethyltetramethylene diperoxide",78-63-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6fc32392-ad92-450a-a9c3-8237f9ee5f33/documents/IUC5-6b37e836-39d6-4056-84bf-80724a44544f_0263ab17-3fd0-4c90-9a03-dc2fa8341dfe.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Di-tert-butyl 1,1,4,4-tetramethyltetramethylene diperoxide",78-63-7,"The oral LD50 is > 2000 mg/kb bw. There was no death and no sign of reaction to treatment.   The dermal LD50 is 4100 ± 1300 mg/kb bw. Deaths occured within 24 hours at the highest dose level. The rapidity with which lethality followed was proportional to the dose level applied. Hind limb weakness, and respiratory slowing preceded death by several days in all but one of the rabbits that died.   A study for acute inhalation toxicity is not available. The use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route is not a relevant route of exposure.   Based on these results, the substance does not have to be classified and has no obligatory labelling requirement for acute oral and dermal toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments).   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The key study was considered reliable without restrictions. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Reliable with restrictions. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fc32392-ad92-450a-a9c3-8237f9ee5f33/documents/IUC5-29737433-a0dc-4b12-a686-3ce82bc440a1_0263ab17-3fd0-4c90-9a03-dc2fa8341dfe.html,,,,,, "Di-tert-butyl 1,1,4,4-tetramethyltetramethylene diperoxide",78-63-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fc32392-ad92-450a-a9c3-8237f9ee5f33/documents/IUC5-29737433-a0dc-4b12-a686-3ce82bc440a1_0263ab17-3fd0-4c90-9a03-dc2fa8341dfe.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Di-tert-butyl 1,1,4,4-tetramethyltetramethylene diperoxide",78-63-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fc32392-ad92-450a-a9c3-8237f9ee5f33/documents/IUC5-29737433-a0dc-4b12-a686-3ce82bc440a1_0263ab17-3fd0-4c90-9a03-dc2fa8341dfe.html,,dermal,LD50,"4,100 mg/kg bw",no adverse effect observed, "Di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide",6731-36-8,"   13-Week feeding of 0.5-4.0% resulted in dose-related reduced wt gain, increased relative liver wt, decrease in relative spleen wt. Mortality ranged from 20-80% in male & female mice. Hematopoesis suppressed in mice fed 2% and 4%,  leading to anemia. Dietary MTD estimated at <=0.5%.    Female & male rats dosed via gavage for 13 weeks at doses of 0, 4, 20, and 100 mg/kg. Test substance-related changes were observed in the livers, and mesenteric lymph nodes: hepatocytic hypertrophy; foam cell accumulation. Hyaline droplet formation with alpha 2u globulin accumulation in male kidneys not compound related. a broad variety of blood marker changes were noted. 13-week NOEL of 4 mg/kg/day.   Female & male rats dosed for 52 weeks at 0, 4, 20, and 100 mg/kg. Effects were seen on liver, mesenteric lymph nodes, kidneys, spleens, duodenums, jejunum and ileums at the end of administration week 52. Hepatocytic hypertrophy w/weakly eosinophilic cytoplasm suggests drug metabolic enzyme induction. Hepatic hypertrophy; Biliary duct hyperplasia; perilobular hepatocyte fatty degeneration (100 mg/kg) significantly increased at the end of week 52. High relative liver weights in females (4 mg/kg), and high absolute & relative liver weights in females (20 mg/kg) and in females and males (100 mg/kg) were observed at the end of administration week 52. Blood coagulation system changes were observed in males (100 mg/kg). Changes in protein and fats in females (20 mg/kg) and females and males (100 mg/kg). Observed kidney toxicity related to the long-term administration of the test substance, viz. week 52, high absolute and relative kidney weights in females at 100 mg/kg. Foam cell accumulation, males & females >=20mg/kg: hepatic sinusoids; spleen red and white pulp in groups administered 20 mg/kg or more; also, at 100mg/kg, in the lamina propria mucosa in the small intestine and in Peyer's patches in females and males. NOEL: 4 mg/kg/day for males and < 4 mg/kg/day for females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f2c4a96-41f3-4b4d-bb62-f84780ebbeb0/documents/IUC5-5ea65f3e-5cd1-41b1-9c20-46afe7b3da18_65dfa5ec-36b3-4586-9168-b2d95c9ba352.html,,,,,, "Di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide",6731-36-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f2c4a96-41f3-4b4d-bb62-f84780ebbeb0/documents/IUC5-5ea65f3e-5cd1-41b1-9c20-46afe7b3da18_65dfa5ec-36b3-4586-9168-b2d95c9ba352.html,Chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "Di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide",6731-36-8,"The oral LD50 for BPTC under the conditions of this study is estimated to be higher than 2000 mg/kg in female and male rats.The LC50 of di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide obtained in this study was estimated to be greater than 5.6 mg/L air (chemically determined mean aerosol concentration). There was no indication of relevant sex-related differences in toxicity of the test item. The median lethal dose of di-tert-butyl-3,3,5-trimethylcyclohexylidene diperoxide (CAS# 6731-36-8) after single dermal administration to rats of both sexes (LD 50), observed over a period of 14 days, is greater than 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f2c4a96-41f3-4b4d-bb62-f84780ebbeb0/documents/IUC5-3a946b45-0e36-48e2-b666-2077ede73831_65dfa5ec-36b3-4586-9168-b2d95c9ba352.html,,,,,, "Di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide",6731-36-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f2c4a96-41f3-4b4d-bb62-f84780ebbeb0/documents/IUC5-3a946b45-0e36-48e2-b666-2077ede73831_65dfa5ec-36b3-4586-9168-b2d95c9ba352.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide",6731-36-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f2c4a96-41f3-4b4d-bb62-f84780ebbeb0/documents/IUC5-3a946b45-0e36-48e2-b666-2077ede73831_65dfa5ec-36b3-4586-9168-b2d95c9ba352.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Di-tert-butyl 3,3,5-trimethylcyclohexylidene diperoxide",6731-36-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f2c4a96-41f3-4b4d-bb62-f84780ebbeb0/documents/IUC5-3a946b45-0e36-48e2-b666-2077ede73831_65dfa5ec-36b3-4586-9168-b2d95c9ba352.html,,inhalation,discriminating conc.,"5,600 mg/m3",no adverse effect observed, Di-tert-butyl sec-butylidene diperoxide,2167-23-9," The oral administration of 2,2-di(tert-butylperoxy) butane (CAS # 2167-23-9) to Wistar Han™:RccHan™:WIST strain rats for up to 7 weeks (including 2 weeks pre-pairing, gestation and early lactation for females) at dose levels 50, 150 and 500 mg/kg bw/day resulted in treatment related effects in animals of either sex treated with 500 and 150 mg/kg bw/day. A No Observed Effect Level (NOEL) for systemic toxicity was considered to be 50 mg/kg bw/day for either sex. A No Observed Adverse Effect Level (NOAEL) can be established at 150 mg/kg bw/day for females. The No Observed Adverse Effect Level (NOAEL) can be established at 150 mg/kg bw/day for males because the kidney microscopic findings do not reflect true systemic toxicity that can be translated and applied to the human health assessment. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4df7ec63-d330-476a-a313-dc2cb4c2553e/documents/c9a1a36a-fc32-4f18-aade-43886e247d0b_25140af6-0a93-4cfa-97c1-77745d8aab3f.html,,,,,, Di-tert-butyl sec-butylidene diperoxide,2167-23-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4df7ec63-d330-476a-a313-dc2cb4c2553e/documents/c9a1a36a-fc32-4f18-aade-43886e247d0b_25140af6-0a93-4cfa-97c1-77745d8aab3f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Di-tert-butyl sec-butylidene diperoxide,2167-23-9," The oral LD50 is > 30 ml per kg body weight. The relative density of di-tert-butyl sec-butylidene diperoxide, 50% solution in isododecane at 20°C is 0.8114. Therefore, the LD 50, as administered, is 24.34 g/kg bw. The inhalation LC50 is higher than 2.42 g/m3 air. The dermal LD50 is >= 2000 mg/kg bw. From these results, the substance is not classified for acute toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4df7ec63-d330-476a-a313-dc2cb4c2553e/documents/7369fca0-c86c-4013-a282-2ce070075ca5_25140af6-0a93-4cfa-97c1-77745d8aab3f.html,,,,,, Di-tert-butyl trisulphide,4253-90-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/617fb4d9-5569-457b-8f2f-0bc818f17bcf/documents/788db280-245f-4b9e-b1e4-dd132b821e63_1d95a045-6aac-4c49-98e1-c3904bb5a5aa.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Di-tert-butyl trisulphide,4253-90-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/617fb4d9-5569-457b-8f2f-0bc818f17bcf/documents/e84c02ed-5072-45e9-afbe-7d5a30414855_1d95a045-6aac-4c49-98e1-c3904bb5a5aa.html,,oral,LD0,"2,000 mg/kg bw",no adverse effect observed, Di-tert-butyl trisulphide,4253-90-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/617fb4d9-5569-457b-8f2f-0bc818f17bcf/documents/e84c02ed-5072-45e9-afbe-7d5a30414855_1d95a045-6aac-4c49-98e1-c3904bb5a5aa.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, "Di-tert-butyl α,α,α',α'-tetramethyl-(p-phenylenedimethylene) diperoxide",2781-00-2,"A read across approach with 1, (3) 4-bis(tert-butylperoxyisopropyl)benzenee is used. In a combined repeated dose and reproduction/developmental screening study conducted with the isomer mixture, according to the OECD Guideline No. 422, the NOAEL was 100 mg/kg bw/day, based on kidney multifocal tubular degeneration / regeneration in parental males at 300 mg/kg and increase in kidney/body weight ratio in parental males and females at 300 mg/kg. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8dc39600-3305-4dd6-ba8e-63dcc7724be1/documents/IUC5-92a4ed18-ea22-403e-a8bc-d788055b6872_393debb9-1116-4640-8e39-f891e200a602.html,,,,,, "Di-tert-butyl α,α,α',α'-tetramethyl-(p-phenylenedimethylene) diperoxide",2781-00-2,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8dc39600-3305-4dd6-ba8e-63dcc7724be1/documents/IUC5-92a4ed18-ea22-403e-a8bc-d788055b6872_393debb9-1116-4640-8e39-f891e200a602.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Di-tert-butyl α,α,α',α'-tetramethyl-(p-phenylenedimethylene) diperoxide",2781-00-2,"From the read across with 1,(3)4-bis(tert-butylperoxyisopropyl)benzene, the dermal and oral LD0 of 1,4-bis(tert-butylperoxyisopropyl)benzene are more than 2000 mg/kg in Sprague Dawley rats. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dc39600-3305-4dd6-ba8e-63dcc7724be1/documents/IUC5-89f9038c-82d6-492a-bec3-2cd6ca74acff_393debb9-1116-4640-8e39-f891e200a602.html,,,,,, "Di-tert-butyl α,α,α',α'-tetramethyl-(p-phenylenedimethylene) diperoxide",2781-00-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dc39600-3305-4dd6-ba8e-63dcc7724be1/documents/IUC5-89f9038c-82d6-492a-bec3-2cd6ca74acff_393debb9-1116-4640-8e39-f891e200a602.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Di-tert-butyl α,α,α',α'-tetramethyl-(p-phenylenedimethylene) diperoxide",2781-00-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dc39600-3305-4dd6-ba8e-63dcc7724be1/documents/IUC5-89f9038c-82d6-492a-bec3-2cd6ca74acff_393debb9-1116-4640-8e39-f891e200a602.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Di-tert-dodecyl disulphide,27458-90-8," OECD 407 study The potential toxicity of di-tert-dodecyl disulfide was evaluated following daily oral administration (gavage) to rats for 4 weeks. On completion of the treatment period, designated animals were held for a 2-week treatment-free period in order to evaluate the reversibility of any findings. This GLP study was carried out according to OECD test guideline No. 407 (03 October 2008). Sprague-Dawley rats were treated daily by the oral route (gavage) with the test item for four weeks as follows: two groups of five males and five females at dose-levels of 50 (group 2) or 250 (group 3) mg/kg/day and another group of ten males and ten females at the dose-level of 1000 mg/kg/day (group 4). One group of ten males and ten females received the vehicle only (corn oil) under the same experimental conditions, and acted as a control group (group 1). A constant dosage volume of 5 mL/kg/day was used. At the end of the treatment period, the animals were sacrificed, except for the first five group 1 and 4 animals per sex, which were kept for a 2-week treatment-free period. The actual test item concentrations in the dose formulations prepared for use in Weeks 2, 3 and 4 were determined using a gas chromatography with analytical method using mass spectrometry detection. The animals were checked daily for mortality and clinical signs. Detailed clinical examinations were performed weekly and a Functional Observation Battery (FOB) was conducted in Week 4. Body weight was recorded once pre-test, on the first day of treatment and then once a week. Food consumption was recorded weekly. Hematology, blood biochemistry, urinalysis and thyroid hormones investigations were performed at the end of the treatment period. Hematological (females) and thyroid hormones parameters were also determined at the end of treatment-free period. The estrous cycle stage was determined for all females, over 4 consecutive days, before sacrifice at the end of the treatment period. On completion of the treatment or treatment-free period, the animals were sacrificed and a full macroscopic post-mortem examination was performed. Designated organs were weighed and selected tissues were preserved. A microscopic examination was performed on designated tissues from control- and high-dose animals sacrificed at the end of the treatment period, on kidney slides immunostained with an antibody for alpha-2-u globulin protein from all males sacrificed at the end of the treatment period, on kidneys from all main and recovery males, on adrenals from recovery males and on liver and thyroids from recovery females. Actual concentrations of the test item in the dose formulations administered to the animals during the study remained within an acceptable range (-1.2% to +8.9%) compared to the nominal concentrations. No unscheduled deaths occurred during the study. No test item treatment-related clinical signs were noted during the study. The FOB results were unaffected by the test item treatment. Body weight change, body weight and food consumption were unaffected by the test item treatment in both sexes. The estrous cycle was not altered by the test item treatment. No treatment-related and/or adverse changes were observed in hematology, blood biochemistry and urinary parameters at the end of the treatment period. Thyroid hormone levels were unaffected by the test item at the end of the treatment and treatment-free periods. At pathology investigations, non-adverse increased incidence and severity of hyaline droplets were seen in the kidneys of males at 250 and 1000 mg/kg/day. When using a manual technique of staining, these droplets were weakly positive for alpha-2-u globulin (immunostaining) at 250 mg/kg/day but not at 1000 mg/kg/day. A semi-automatic technique of staining performed in kidneys from males treated at 1000 mg/kg/day showed a strong positive staining of these droplets suggesting they corresponded to alpha-2-u globulin. Following a two week treatment-free period, minimal increased hyaline droplets were still present in kidneys of males previously treated at 1000 mg/kg/day when compared to controls.   Di-tert-dodecyl disulfide was clinically well tolerated at all dose-levels and no effects were observed on FOB and estrous cycle parameters. At 1000 mg/kg/day, the test item administration did not induce any adverse changes in clinical pathology. Non-adverse histopathological findings were noted (i.e. hyaline droplets in kidneys) in males which were partially reversible at the end of the treatment-free period. At 250 mg/kg/day, the test item administration did not induce any relevant clinical pathology changes. Hyaline droplets were observed in males. At 50 mg/kg/day, the test item did not induce any changes in clinical pathology or in either macroscopic or microscopic evolutions.  Consequently, under the experimental conditions of the study, the No Observed Adverse Effect Level (NOAEL) after the 4-week treatment period was established at 1000 mg/kg/day.   Range finding study The objective of this preliminary study was to evaluate the potential toxicity of di-tert-dodecyl disulfide, following daily oral administration (gavage) to rats for 2 weeks in order to assist the selection of dose-levels for a further 4-week toxicity study to be performed in the same species (Papineau, 2016).Three groups of five male and five female Sprague-Dawley rats received di-tert-dodecyl disulfide, by daily oral administration (gavage) for 14 days, at dose-levels of 100, 300 or 1000 mg/kg/day. The test item was administered as a emulsion in the vehicle (corn oil) at a constant dosage-volume of 5 mL/kg/day. A control group of five males and five females received the vehicle alone under the same experimental conditions. Clinical signs and mortality were checked daily. Body weight was recorded once before the beginning of the treatment period, and then twice a week. Food consumption was recorded twice a week during the study period and water consumption was recorded twice a week from Day 8.On completion of the treatment period, the animals were euthanized and a full macroscopic post-mortem examination was performed. Designated tissues were weighed and preserved. No microscopic examination was performed. Neither unscheduled deaths nor treatment-related clinical signs were observed during the study. There were no test item-related effects on body weight and food intake over the study period or on water consumption over the second week of treatment. At necropsy, at the end of the treatment period, there were slightly higher spleen weights in males at 1000 mg/kg/day (up to +22%) for which a relationship to the test item treatment could not be excluded. There were no relevant changes in organ weights in females. There were no macroscopic findings related to the test item treatment. Di-tert-dodecyl disulfide was clinically well tolerated and did not induce adverse body weight, organ or macroscopic changes. Consequently, under the experimental conditions of the study, the Maximal Tolerated Dose (MTD) after a 2-week treatment period was established to be at least 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea737103-d6c9-4129-a9ab-630e9d28e7af/documents/1be3d033-fb4c-482b-a128-5b59fa50a99f_985c4059-c0a1-49c9-afd3-04aa6d3e943b.html,,,,,, Di-tert-dodecyl disulphide,27458-90-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea737103-d6c9-4129-a9ab-630e9d28e7af/documents/1be3d033-fb4c-482b-a128-5b59fa50a99f_985c4059-c0a1-49c9-afd3-04aa6d3e943b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Di-tert-dodecyl disulphide,27458-90-8," Acute oral toxicity The potential acute toxicity of DI-TERT-DODECYL DISULPHIDE was evaluated following a single oral administration (gavage) to rats (Papineau, 2016). This study was conducted in compliance with OECD Guideline No. 423 and the principles of Good Laboratory Practices. The test item was administered once by oral route (gavage) to two groups of three fasted female Sprague-Dawley rats under a dosage-volume of 10 mL/kg. The test item was prepared in corn oil. Based on the expected low toxicity of the test item data, the starting dose-level of 2000 mg/kg was chosen. After the first assay, as no mortality was observed, the results were confirmed in other females treated at the same dose-level. Each animal was observed at least once a day for mortality and clinical signs for 15 days. Body weight was recorded on Day 1 and then on Days 8 and 15. On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination. No tissues were preserved. No unscheduled deaths occurred during the study. At 2000 mg/kg, piloerection together with dyspnea were observed on Day 1, in the first 4 hours after treatment in 3/6 females. No clinical signs were noted in the remaining 3/6 females treated at the same dose-level. Compared to historical control data, body weight change and body weight of the animals were considered to be unaffected by the test item treatment. At the end of the observation period, there were no macroscopic findings at necropsy. Under the experimental conditions of this study, the oral LD0 of DI-TERT-DODECYL DISULPHIDE was higher than 2000 mg/kg in rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea737103-d6c9-4129-a9ab-630e9d28e7af/documents/IUC5-0ce02d91-1c39-47a1-bd66-f394bdccbc4f_985c4059-c0a1-49c9-afd3-04aa6d3e943b.html,,,,,, Di-tert-dodecyl disulphide,27458-90-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea737103-d6c9-4129-a9ab-630e9d28e7af/documents/IUC5-0ce02d91-1c39-47a1-bd66-f394bdccbc4f_985c4059-c0a1-49c9-afd3-04aa6d3e943b.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Di-tert-pentyl peroxide,10508-09-5,"- Oral route (OECD 407, K1, KS):  the NOAEL is 300 mg/kg bw/d in males based on the association of renal alpha2µ-globulin hyaline droplets with tubular basophilia, suggesting previous chronic cell damage and increased cell turnover. The NOAEL in females is 1000 mg/kg. There were no other effects that could be considered as adverse at any doses. Renal alpha2µ globulin hyaline droplets are considered to be specific to male rats and therefore not relevant for human. - Inhalation route (OECD 413, K1, KS): an analogy with di-tert-butyl peroxide CAS# 110-05-4  was proposed. A few modest changes at the highest concentration tested are observed (increases in liver and kidney weight and altered plasma levels of cholesterol and creatinine). No treatment-related changes were observed at the lower concentrations. Since the changes at the high-concentration were considered not to constitute adverse effects, this exposure level (993 mg/m3 actual concentration) was a No-Observed- Adverse-Effect Concentration (NOAEC).   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f210f82-0703-46f6-b8f6-d59e7b8adc80/documents/IUC5-684a0afe-d5f3-4c3f-ab62-cdbc3f733d3b_4a32d1a9-5ec1-4c79-a74e-bd91c73993d4.html,,,,,, Di-tert-pentyl peroxide,10508-09-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f210f82-0703-46f6-b8f6-d59e7b8adc80/documents/IUC5-684a0afe-d5f3-4c3f-ab62-cdbc3f733d3b_4a32d1a9-5ec1-4c79-a74e-bd91c73993d4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Di-tert-pentyl peroxide,10508-09-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f210f82-0703-46f6-b8f6-d59e7b8adc80/documents/IUC5-684a0afe-d5f3-4c3f-ab62-cdbc3f733d3b_4a32d1a9-5ec1-4c79-a74e-bd91c73993d4.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,993 mg/m3,,rat Di-tert-pentyl peroxide,10508-09-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f210f82-0703-46f6-b8f6-d59e7b8adc80/documents/IUC5-684a0afe-d5f3-4c3f-ab62-cdbc3f733d3b_4a32d1a9-5ec1-4c79-a74e-bd91c73993d4.html,Repeated dose toxicity – local effects,inhalation,NOAEC,993 mg/m3,no adverse effect observed,rat Di-tert-pentyl peroxide,10508-09-5,"Acute oral toxicity: Based on the results of two key studies (similar to OECD 401, Kr.1): LD0/rat > 2000 mg/kg bw.   Acute dermal toxicity: The dermal LD0 of the test item Di-tert-amyl peroxide is higher than 2000 mg/kg in male/female rats (Similar to OECD 402, Kr.1).   Acute inhalation toxicity: There is no data on acute inhalation toxicity on di-tert-amyl peroxide. A read across with di-tert-butyl peroxide is proposed to fulfill this data gap. By analogy, the LC0 was estimated to be greater than 22 mg/L air (4 hours of exposure, vapour).   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f210f82-0703-46f6-b8f6-d59e7b8adc80/documents/IUC5-681db3b9-ad93-4363-a9cc-edfaa74baa4d_4a32d1a9-5ec1-4c79-a74e-bd91c73993d4.html,,,,,, Di-tert-pentyl peroxide,10508-09-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f210f82-0703-46f6-b8f6-d59e7b8adc80/documents/IUC5-681db3b9-ad93-4363-a9cc-edfaa74baa4d_4a32d1a9-5ec1-4c79-a74e-bd91c73993d4.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Di-tert-pentyl peroxide,10508-09-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f210f82-0703-46f6-b8f6-d59e7b8adc80/documents/IUC5-681db3b9-ad93-4363-a9cc-edfaa74baa4d_4a32d1a9-5ec1-4c79-a74e-bd91c73993d4.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Di-tert-pentyl peroxide,10508-09-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f210f82-0703-46f6-b8f6-d59e7b8adc80/documents/IUC5-681db3b9-ad93-4363-a9cc-edfaa74baa4d_4a32d1a9-5ec1-4c79-a74e-bd91c73993d4.html,,inhalation,discriminating conc.,"22,000 mg/m3",no adverse effect observed, Ditetradecyl fumarate,10341-03-4,"In conclusion, no human hazard for systemic toxicity after repeated oral exposure was identified for the PFAE fumarate category members. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fc27afc-0ee9-4eb3-9768-5986ca529a74/documents/IUC5-c6cd27b4-2f05-4099-829b-ca453ea1b14f_01f4458c-ccf9-45a9-b3d4-a4a812fbc7b9.html,,,,,, Ditetradecyl fumarate,10341-03-4,The available acute oral toxicity study within this category (according to OECD TG 423) resulted in an acute oral LD50 value > 5000 mg/kg bw. The available acute dermal toxicity study within the category (according to OECD TG 402) resulted in an acute dermal LD50 value > 5000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fc27afc-0ee9-4eb3-9768-5986ca529a74/documents/IUC5-be26e5f4-31ea-4e8b-a52f-4d31302badf2_01f4458c-ccf9-45a9-b3d4-a4a812fbc7b9.html,,,,,, Ditetradecyl peroxydicarbonate,53220-22-7, The subchronic toxicity profile of the test item was assessed following oral administration in a study performed according to OECD Guideline 408 in rats. Based on the observations in this study the No Observed (Adverse) Effect Level (NO(A)EL) was determined as follows:  NOAEL for male and female rats: 1000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcb4bdcb-65da-4c32-968c-89838f64cbf9/documents/4cfb6902-7641-424f-9a0c-22c689478d1c_7b5482f8-c2f7-4dcc-8841-9943215d3ab8.html,,,,,, Ditetradecyl peroxydicarbonate,53220-22-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcb4bdcb-65da-4c32-968c-89838f64cbf9/documents/4cfb6902-7641-424f-9a0c-22c689478d1c_7b5482f8-c2f7-4dcc-8841-9943215d3ab8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Ditetradecyl peroxydicarbonate,53220-22-7,In an acute oral toxicity study according to OECD TG 401 the LD50 value was determined to be above 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcb4bdcb-65da-4c32-968c-89838f64cbf9/documents/0eb9e843-8f2c-4024-97c8-44f29fe06857_7b5482f8-c2f7-4dcc-8841-9943215d3ab8.html,,,,,, Ditetradecyl peroxydicarbonate,53220-22-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcb4bdcb-65da-4c32-968c-89838f64cbf9/documents/0eb9e843-8f2c-4024-97c8-44f29fe06857_7b5482f8-c2f7-4dcc-8841-9943215d3ab8.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Ditolyl ether,28299-41-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP guideline study ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2ac9250-0490-45d7-8e8b-a21b0bf40a4c/documents/IUC5-fc1f11d1-0820-4ea2-aa64-f307cd8a0928_51c24a7d-fc73-45f9-84a5-4a73166fa048.html,,,,,, Ditolyl ether,28299-41-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a2ac9250-0490-45d7-8e8b-a21b0bf40a4c/documents/IUC5-fc1f11d1-0820-4ea2-aa64-f307cd8a0928_51c24a7d-fc73-45f9-84a5-4a73166fa048.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,132 mg/kg bw/day,,rat Ditolyl ether,28299-41-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): All available studies are scientifically acceptable and well documented. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Scientifically acceptable and well documented Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Scientifically acceptable and well documented ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2ac9250-0490-45d7-8e8b-a21b0bf40a4c/documents/IUC5-6b6317d4-a7c5-47e9-a0a1-51c1b4625bcb_51c24a7d-fc73-45f9-84a5-4a73166fa048.html,,,,,, Ditolyl ether,28299-41-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2ac9250-0490-45d7-8e8b-a21b0bf40a4c/documents/IUC5-6b6317d4-a7c5-47e9-a0a1-51c1b4625bcb_51c24a7d-fc73-45f9-84a5-4a73166fa048.html,,dermal,discriminating dose,"2,587 mg/kg bw",no adverse effect observed, Ditolyl ether,28299-41-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2ac9250-0490-45d7-8e8b-a21b0bf40a4c/documents/IUC5-6b6317d4-a7c5-47e9-a0a1-51c1b4625bcb_51c24a7d-fc73-45f9-84a5-4a73166fa048.html,,inhalation,discriminating conc.,521 mg/m3,no adverse effect observed, Diundecyl phthalate,3648-20-2,"Weight of evidence. Experimental results from short and long-term repeated dose toxicity studies performed with the test substance and some analogues are available. A weight of evidence approach has been applied. Several experimental studies are available with a Klimisch score of 2 or 4.   Diundecyl phthalate (DUP): In one study following repeated exposure over 21 days, DUP was demonstrated to cause moderate proliferation of peroxisomes in the liver of rats. In a 28-d repeated dose toxicity study following method similar to OECD guideline 407, effects in sperm count and sperm motility of Sprague-Dawley male rats were observed at a dose of 500 mg/kg bw/day. Diisononyl phthalate (DINP): combined chronic toxicity/carcinogenicity following method similar to OECD guideline 453. Based on the read-across approach, the NOEL of DUP is determined to be 19.28 mg/kg/day in a 2-year chronic toxicity study with rats. Diisononyl phthalate (DINP): 13-weeks repeated dose toxicity study in marmosets following method similar to OECD guideline 409. Based on the read-across approach, the NOEL of DUP is calculated to be 567.02 mg/kg/day. Diisodecyl phthalate (DIDP): 13-weeks repeated dose toxicity studies with rats and dogs. Based on the read-across approach, the NOEL of DUP is calculated to be 79.71 mg/kg bw/day in dogs and 159.42 mg/kg bw/day in rats.   In a weight of evidence approach the key study was selected to be the 2 -year toxicity study performed with DINP for DNEL derivation since it represents the longest study period and also has demonstrated to be a good quality with reliable data.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efd18153-6c80-49dc-8b8c-f890c1b9a23d/documents/b368c93c-a866-45be-a3ca-e613ebfb6841_f3ec9115-632c-4d6d-9ab2-495992336264.html,,,,,, Diundecyl phthalate,3648-20-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efd18153-6c80-49dc-8b8c-f890c1b9a23d/documents/b368c93c-a866-45be-a3ca-e613ebfb6841_f3ec9115-632c-4d6d-9ab2-495992336264.html,Chronic toxicity – systemic effects,oral,NOAEL,19.28 mg/kg bw/day,,rat Diundecyl phthalate,3648-20-2," Acute oral toxicity: Weight of evidence. Experimental results from acute oral toxicity studies performed with the test substance and some analogues are available: Diundecyl phthalate (DUP): No information on the method used. The acute oral LD50 value of the test substance is higher than 15.8 g/kg bw in rats. Ditridecyl phthalate (DTP): Method in accordance with OECD Guideline 401, following GLP. Based on the read-across approach, the acute oral LD50 value of DUP is determined to be higher than 1788.6 mg/kg bw in rats. Diisodecyl phthalate (DIDP): No information on the method used. Based on the read-across approach, the acute oral LD50 value of DUP is 68.02 g/kg bw in rats. Diisodecyl phthalate (DIDP): Method of Thompson (Thompson W R, 1945) and tables of Weil (Weil C. S., 1952). Based on the read-across approach, the acute oral LD50 value of DUP is higher than 63.77 g/kg bw in rats. In a weight of evidence approach the key study was selected to be the acute toxicity study performed with DUP for CSA since no toxicity was observed in any of the studies performed with different phthalates. Acute inhalation toxicity: Data waiving (study scientifically not necessary): According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The information is provided for dermal route. Acute dermal toxicity: Key study. Test method in accordance with OECD Test Guideline 402, following GLP. The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efd18153-6c80-49dc-8b8c-f890c1b9a23d/documents/234a5728-c3a7-473e-9f12-2ec72b7c2fc4_f3ec9115-632c-4d6d-9ab2-495992336264.html,,,,,, Diundecyl phthalate,3648-20-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efd18153-6c80-49dc-8b8c-f890c1b9a23d/documents/234a5728-c3a7-473e-9f12-2ec72b7c2fc4_f3ec9115-632c-4d6d-9ab2-495992336264.html,,oral,LD50,"15,800 mg/kg bw",no adverse effect observed, Diundecyl phthalate,3648-20-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efd18153-6c80-49dc-8b8c-f890c1b9a23d/documents/234a5728-c3a7-473e-9f12-2ec72b7c2fc4_f3ec9115-632c-4d6d-9ab2-495992336264.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Diundecyl phthalate, branched and linear",85507-79-5,Sub-chronic toxicity; oral: NOAEL - Males - 79.6 mg/kg/day; Females - 303.9 mg/kg/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b81e903-0439-4e2d-bb07-d5e7b00ee028/documents/IUC5-33334e30-85fb-4c63-a418-bd75ccd782e9_c036327d-aa88-4357-a45d-bc87a26ad5bd.html,,,,,, "Diundecyl phthalate, branched and linear",85507-79-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b81e903-0439-4e2d-bb07-d5e7b00ee028/documents/IUC5-33334e30-85fb-4c63-a418-bd75ccd782e9_c036327d-aa88-4357-a45d-bc87a26ad5bd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,79.6 mg/kg bw/day,,rat "Diundecyl phthalate, branched and linear",85507-79-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b81e903-0439-4e2d-bb07-d5e7b00ee028/documents/IUC5-101add0f-f9b6-4098-b3fb-5dcf6b84e07d_c036327d-aa88-4357-a45d-bc87a26ad5bd.html,,oral,LD50,"15,800 mg/kg bw",no adverse effect observed, "Diundecyl phthalate, branched and linear",85507-79-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b81e903-0439-4e2d-bb07-d5e7b00ee028/documents/IUC5-101add0f-f9b6-4098-b3fb-5dcf6b84e07d_c036327d-aa88-4357-a45d-bc87a26ad5bd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Divanadium trioxide,1314-34-7," Inhalation: A study via the inhalation route is available for divanadium trioxide. However, data via the oral route are not available for divanadium trioxide but exist for other vanadium substances. The rationale for read-across to divanadium trioxide including the limitations thereof is summarised below (see discussion). In a 14-d repeated-dose inhalation toxicity study, Sprague-Dawley rats were exposed to micronised vanadium trioxide powder via nose-only inhalation. Test-substance related mortality or any clinical signs of systemic toxicity were not observed at any exposure level. Body weights/body weight gain and food consumption were significantly decreased only at the highest exposure (0.25 mg/L) in males and females. In summary, based on the local effects in the respiratory tract of the test animals at the high exposure level (0.25 mg/L), the NOAEC was 0.02 mg/L (20 mg V2O3/m3). All effects on BAL parameters, lung weights and lung histopathology seen at the lower exposure levels were considered as adaptive responses to divanadium trioxide exposure, rather than an indication of local toxicity. Information on repeated dose toxicity following inhalation exposure to V2O5 is available in a NTP study (NTP 2002) with exposure of male and female rats and mice to V2O5 over 16-days, 3-months and 2-years. Pulmonary reactivity to vanadium pentoxide was also investigated following subchronic inhalation exposure in a non-human primate animal model. However, local effects on the respiratory tract are not considered relevant for divanadium trioxide. Oral: In an unpublished study report with vanadium carbide nitride, relevant treatment-related effects were not observed in rats after 28-days oral exposure up to the limit dose of 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e23c7de-2232-456a-ba64-238e27faa38c/documents/IUC5-37af8d70-19f4-4bee-88a7-2ffffd27d1d4_1d27a884-e176-4911-9530-d241384d4b30.html,,,,,, Divanadium trioxide,1314-34-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e23c7de-2232-456a-ba64-238e27faa38c/documents/IUC5-37af8d70-19f4-4bee-88a7-2ffffd27d1d4_1d27a884-e176-4911-9530-d241384d4b30.html,Repeated dose toxicity – local effects,inhalation,NOAEC,20 mg/m3,no adverse effect observed,rat Divanadium trioxide,1314-34-7," Divanadium trioxide is not acutely toxic via the oral, dermal, or inhalation route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e23c7de-2232-456a-ba64-238e27faa38c/documents/IUC5-967c2846-9a8a-4398-81ff-aa87944840ec_1d27a884-e176-4911-9530-d241384d4b30.html,,,,,, Divanadium trioxide,1314-34-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e23c7de-2232-456a-ba64-238e27faa38c/documents/IUC5-967c2846-9a8a-4398-81ff-aa87944840ec_1d27a884-e176-4911-9530-d241384d4b30.html,,oral,LD50,"5,639 mg/kg bw",no adverse effect observed, Divanadium trioxide,1314-34-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e23c7de-2232-456a-ba64-238e27faa38c/documents/IUC5-967c2846-9a8a-4398-81ff-aa87944840ec_1d27a884-e176-4911-9530-d241384d4b30.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, Divanadium trioxide,1314-34-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e23c7de-2232-456a-ba64-238e27faa38c/documents/IUC5-967c2846-9a8a-4398-81ff-aa87944840ec_1d27a884-e176-4911-9530-d241384d4b30.html,,inhalation,discriminating conc.,"6,650 mg/m3",no adverse effect observed, Divanadium tris(sulphate),13701-70-7,"Description of key information - soluble vanadium substances group (oral) A comprehensive literature search was recently conducted for the vanadium category substances, to source relevant information for the hazard and risk assessment. For the group of the soluble vanadium substances, a limited number of studies is available, and the different experimental approaches lead to a variety of endpoints measured. Of the limited effects noted following oral exposure with soluble vanadium substances, it appears most likely that effects on haematological parameters are the most consistently reported among a number of investigators (Mountain et al 1953, Zaporowska et al. 1993, Scibior et al 2006, Scibior, 2005, NTP, 2002, NTP, 2023). Altogether, haematological effects have been found with a variety of different vanadium compounds including sodium metavanadate, vanadium pentoxide, and ammonium metavanadate supporting the use of this endpoint for risk assessment purposes. Furthermore, epithelial hyperplasia in the small intestine of rats and mice were observed after the administration of sodium metavanadate and vanadyl sulfate (NTP, 2023). Therefore, this endpoint should also be considered for risk assessment purposes. Information on repeated dose toxicity following inhalation exposure to divanadium pentaoxide is available in a NTP study (k_NTP 2002) with exposure of male and female rats and mice to V2O5 over 16-days, 3-months and 2-years. Pulmonary reactivity to divanadium pentaoxide was also investigated following subchronic inhalation exposure in a non-human primate animal model. Data of the repeated-dose toxicity via the dermal route are not available for any vanadium substance. Following the HERAG guidance for metals and metal salts (see section 7.1.2 of the technical dossier: dermal absorption), negligible percutaneous uptake based on minimal penetration, i.e. a dermal absorption rate in the range of maximally 0.1 - 1.0 %, can be anticipated. Dermal absorption in this order of magnitude is not considered to be “significant”. Thus, regarding repeated-dose toxicity of vanadium substances, the dermal exposure route is not expected to be the most relevant. EBRC (2007) HERAG fact sheet - Assessment of occupational dermal exposure and dermal absorption for metals and inorganic metal compounds, EBRC Consulting GmbH, Hannover, Germany, August 2007, 49 pages.   Further information: Divanadium pentaoxide has been excluded from the soluble vanadium substances read-across group due to its legal classification. Thus, studies conducted with divanadium pentaoxide are reported for information purposes only. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d794c081-ad5f-4901-be93-b075c41b426b/documents/IUC5-2a73168e-31f3-48eb-999c-a718fed88eee_1510d85e-50b9-4ac6-930b-c6a7906b1906.html,,,,,, Divanadium tris(sulphate),13701-70-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d794c081-ad5f-4901-be93-b075c41b426b/documents/IUC5-2a73168e-31f3-48eb-999c-a718fed88eee_1510d85e-50b9-4ac6-930b-c6a7906b1906.html,Repeated dose toxicity – local effects,inhalation,LOAEC,2.24 mg/m3,adverse effect observed,rat Divanadyl pyrophosphate,65232-89-5,Oral: Read-Across; LOAEL = 100 ppm corresponding to 3 mg V/kg/day; rat; 103 d; no guideline followed; non-GLP; K3 Inhalation: Read-Across; NOAEC = 1 mg/m³; rat; 90 d; guideline not specified; GLP; K1 Dermal: no study available ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/762d5c67-da9a-43b2-8561-acabb6d8d260/documents/05ee1f9f-b81f-4cf5-84b3-14553c755ecd_3ae20f57-06af-4495-a914-e4603de3065e.html,,,,,, Divanadyl pyrophosphate,65232-89-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/762d5c67-da9a-43b2-8561-acabb6d8d260/documents/05ee1f9f-b81f-4cf5-84b3-14553c755ecd_3ae20f57-06af-4495-a914-e4603de3065e.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,3 mg/kg bw/day,,rat Divanadyl pyrophosphate,65232-89-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/762d5c67-da9a-43b2-8561-acabb6d8d260/documents/05ee1f9f-b81f-4cf5-84b3-14553c755ecd_3ae20f57-06af-4495-a914-e4603de3065e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,1 mg/m3,,rat Divanadyl pyrophosphate,65232-89-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/762d5c67-da9a-43b2-8561-acabb6d8d260/documents/05ee1f9f-b81f-4cf5-84b3-14553c755ecd_3ae20f57-06af-4495-a914-e4603de3065e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1 mg/m3,adverse effect observed,rat Divanadyl pyrophosphate,65232-89-5,"Oral: In a gavage GLP study (K2) according to EPA OPP 81-1, test item (600, 1200, 2500, 3500, 5000 mg/kg bw) was administered to 5 Sprague Dawley rats per sex and dose. Acute oral LD50 was calculated to be 911 mg/kg bw. Inhalation: Read-Across. In an acute inhalational study (4 hours) conducted in male and female F344/N rats according to OECD TG 436 (GLP, K2), doses tested were 2.0, 0.5, 0.05 mg/L. LC50 was found to be 0.25 mg/L.  In a second study (GLP, K2), conducted similarly to OECD TG 403, male Crl:CD*BR rats were exposed to test atmospheres of 0,034, 0.067, 0.23, 0.51, 0.92, 2.3, 5.6, or 7.8 mg/L of registered substance Divanadyl Pyrophosphate for single, 4-hour exposure periods. The approximate lethal concentration (ALC) was found to be 0.067 mg/L. Dermal:  In a GLP (K2) study conducted according to EPA OPP 81-2, test item was given at a dose of 5000 mg/kg bw to 5 New Zealand White rabbits. After the single dose (24h skin exposure with dressing), animals were observed for 14 days. LD50 was found to be > 5000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/762d5c67-da9a-43b2-8561-acabb6d8d260/documents/IUC5-ab599e6c-2aa1-4cb6-bda1-792107ecd472_3ae20f57-06af-4495-a914-e4603de3065e.html,,,,,, Divanadyl pyrophosphate,65232-89-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/762d5c67-da9a-43b2-8561-acabb6d8d260/documents/IUC5-ab599e6c-2aa1-4cb6-bda1-792107ecd472_3ae20f57-06af-4495-a914-e4603de3065e.html,,oral,LD50,911 mg/kg bw,adverse effect observed, Divanadyl pyrophosphate,65232-89-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/762d5c67-da9a-43b2-8561-acabb6d8d260/documents/IUC5-ab599e6c-2aa1-4cb6-bda1-792107ecd472_3ae20f57-06af-4495-a914-e4603de3065e.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Divanadyl pyrophosphate,65232-89-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/762d5c67-da9a-43b2-8561-acabb6d8d260/documents/IUC5-ab599e6c-2aa1-4cb6-bda1-792107ecd472_3ae20f57-06af-4495-a914-e4603de3065e.html,,inhalation,discriminating conc.,0.067 mg/L,adverse effect observed, Dizinc pyrophosphate,7446-26-6," No data regarding effects on repeated dose toxicity are available for dizinc pyrophosphate. Reliable data are available from zinc sulfate heptahydrate (CAS 7446 -20 -0). The zinc ion is considered to be the toxicologically relevant element and thus a read across to zinc sulfate heptahydrate is reliable. Oral, rat: NOAEL (zinc sulfate heptahydrate) = 234 and 243 mg/kg bw/day for males and females, respectively. This corresponds to 53.5 mg Zn2 +/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/484703fa-0d44-4999-b690-51b6d75f8d21/documents/65dac8b0-ad09-410b-9711-3ea2deaae46a_c7b480bd-eea6-4e56-a25a-2981d5245090.html,,,,,, Dizinc pyrophosphate,7446-26-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/484703fa-0d44-4999-b690-51b6d75f8d21/documents/65dac8b0-ad09-410b-9711-3ea2deaae46a_c7b480bd-eea6-4e56-a25a-2981d5245090.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,234 mg/kg bw/day,,rat Dizinc pyrophosphate,7446-26-6," Oral (OECD 423, RL1), rat: LD50 cut-off = 5000 mg/kg bw Inhalation (OECD 436, RL2), rat: LC50 > 4.73 mg/L Dermal (OECD 402, RL1), guinea pigs: LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/484703fa-0d44-4999-b690-51b6d75f8d21/documents/6ecb3b31-18dd-4442-95d8-b29255a8b3c7_c7b480bd-eea6-4e56-a25a-2981d5245090.html,,,,,, DL-malic acid,617-48-1,Malic acid and fumaric acid accur naturally in many foods and synthetic forms of these acids are considered suitable as food additives.A 2 year chronic study gave a NOAEL of 600 mg/kg ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e04c9619-1fb0-40a1-b7c6-da90249b5c16/documents/IUC5-d44c8059-7872-464e-a4c6-18146c55a090_9c95def7-fa7e-45bd-8694-8658d9cd78f9.html,,,,,, DL-malic acid,617-48-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e04c9619-1fb0-40a1-b7c6-da90249b5c16/documents/IUC5-d44c8059-7872-464e-a4c6-18146c55a090_9c95def7-fa7e-45bd-8694-8658d9cd78f9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,, DL-malic acid,617-48-1,Malic acid is conisdered to be of low toxicity and is widely used in food.A discriminating dose of > 2000 mg is considered a conservative figure (LD 50 fumaric acid > 10 000 mg/kg) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e04c9619-1fb0-40a1-b7c6-da90249b5c16/documents/IUC5-683e3f7b-d827-4020-967a-a059110b5448_9c95def7-fa7e-45bd-8694-8658d9cd78f9.html,,,,,, DL-malic acid,617-48-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e04c9619-1fb0-40a1-b7c6-da90249b5c16/documents/IUC5-683e3f7b-d827-4020-967a-a059110b5448_9c95def7-fa7e-45bd-8694-8658d9cd78f9.html,,oral,discriminating dose,"2,000 mg/kg bw",, DL-malic acid,617-48-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e04c9619-1fb0-40a1-b7c6-da90249b5c16/documents/IUC5-683e3f7b-d827-4020-967a-a059110b5448_9c95def7-fa7e-45bd-8694-8658d9cd78f9.html,,dermal,discriminating dose,"2,000 mg/kg bw",, DL-α-(aminomethyl)-p-hydroxybenzylic alcohol hydrochloride,770-05-8,"The oral repeat dose toxicity for Octopamine Hydrocloride was determined in a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD guideline 422), and the following No Observed Adverse Effect levels (NOAELs) of Octopamine hydrochloride were established: Parental NOAEL: 300 mg/kg, based on mortality and clinical signs of toxicity at 1000/600 mg/kg which resulted in premature termination of the males (on Study Day 10). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5fb4fe20-804b-4017-8e11-1b73b0f9060a/documents/c4a0f6dd-de7a-4d47-a484-6a57319e919a_824c2356-19a0-4546-a206-1141311344d9.html,,,,,, DL-α-(aminomethyl)-p-hydroxybenzylic alcohol hydrochloride,770-05-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5fb4fe20-804b-4017-8e11-1b73b0f9060a/documents/c4a0f6dd-de7a-4d47-a484-6a57319e919a_824c2356-19a0-4546-a206-1141311344d9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat DL-α-(aminomethyl)-p-hydroxybenzylic alcohol hydrochloride,770-05-8," The oral LD50 value of Octopamine hydrochloride in Wistar rats was established to exceed 2000 mg/kg body weight. The dermal toxicity study was waived as the substance does not meet the criteria for classification as acutely toxic or STOT SE by the oral route and no systemic effects were observed in in vio studies with dermal exposure. The inhalation toxicity study was waived because exposure to humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of inhalable size. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fb4fe20-804b-4017-8e11-1b73b0f9060a/documents/3aad7c36-5f43-4d3d-aac5-37aa2065a744_824c2356-19a0-4546-a206-1141311344d9.html,,,,,, DL-α-(aminomethyl)-p-hydroxybenzylic alcohol hydrochloride,770-05-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fb4fe20-804b-4017-8e11-1b73b0f9060a/documents/3aad7c36-5f43-4d3d-aac5-37aa2065a744_824c2356-19a0-4546-a206-1141311344d9.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, D-N-(4-hydroxyphenyl)glycine,22818-40-2,"oral LD50 (male, female) > 2000 mg/kg bw (no mortality observed) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7063e386-0621-4298-a4d8-b6be73f8d023/documents/IUC5-bce5f95a-14d0-49ae-965e-c716c6b79052_6da74138-bf9d-4f0e-a7b8-80c84c7ff811.html,,,,,, Docosyl methacrylate,16669-27-5," No studies on repeated oral dose toxicity for the target substance Docosyl methacrylate are available. Therefore, read-across from studies with the primary metabolite Docosan-1-ol (Behenyl alcohol, CAS 661-19-8) as well as with the structurally analogous substance Dodecyl methacrylate (CAS 142-90-5) was performed. Oral: Daily oral administration of Dodecyl methacrylate to Sprague-Dawley rats in a study according OECD TG 422 did not elicit any signs of systemic toxicity up to the highest dose tested. The NOAEL for parental toxicity was considered to be 1000 mg/kg bw/day. In two subchronic studies with Behenyl alcohol (Docosan-1-ol), no adverse effects were observed up to the highest dose tested. The NOAEL for male and female rats was 1000 mg/kg bw/day and for dogs of both sexes the NOAEL was 2000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16a1db5e-0777-47c7-8b58-df48cd830607/documents/0e496b9f-bca8-4329-8a6e-7a54997e18b6_bfcffd4d-d8f5-489a-b8c0-af5e9cc4e797.html,,,,,, Docosyl methacrylate,16669-27-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16a1db5e-0777-47c7-8b58-df48cd830607/documents/0e496b9f-bca8-4329-8a6e-7a54997e18b6_bfcffd4d-d8f5-489a-b8c0-af5e9cc4e797.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Docosyl methacrylate,16669-27-5, The acute toxicity of Docosyl methacrylate is very low (LD50 > 2000 mg/kg bw). The acute toxicity of the structural analogue substance Isodecyl methacrylate by the dermal route (LD50: > 3000 mg/kg bw) is very low as well. The inhalation route is not of relevance due to the very low vapour pressure estimated for solid waxen Docosyl methacrylate. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16a1db5e-0777-47c7-8b58-df48cd830607/documents/8340a607-e97a-4183-b101-7a2d271a172a_bfcffd4d-d8f5-489a-b8c0-af5e9cc4e797.html,,,,,, Docosyl methacrylate,16669-27-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16a1db5e-0777-47c7-8b58-df48cd830607/documents/8340a607-e97a-4183-b101-7a2d271a172a_bfcffd4d-d8f5-489a-b8c0-af5e9cc4e797.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Docosyl methacrylate,16669-27-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16a1db5e-0777-47c7-8b58-df48cd830607/documents/8340a607-e97a-4183-b101-7a2d271a172a_bfcffd4d-d8f5-489a-b8c0-af5e9cc4e797.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, Docosyl stearate,22413-03-2," Oral (OECD 422): NOAEL m/f rat ≥ 1000 mg/kg bw/day (read-across from CAS 17671-27-1, key) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b485dfcc-c5a8-4f75-9574-46d54f6fa61c/documents/e3ce1624-830e-43ca-9cbf-d308de5bc7a0_6286a54f-e3c1-4ed5-84fe-ba8ad75dc65f.html,,,,,, Docosyl stearate,22413-03-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b485dfcc-c5a8-4f75-9574-46d54f6fa61c/documents/e3ce1624-830e-43ca-9cbf-d308de5bc7a0_6286a54f-e3c1-4ed5-84fe-ba8ad75dc65f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Docosyl stearate,22413-03-2," Oral (OECD 423): LD50 (female, rat) > 2000 mg/kg bw Dermal (OECD 402): LD50 (male/female, rat) > 2000 mg/kg bw (read-across from CAS 3687-46-5, key) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b485dfcc-c5a8-4f75-9574-46d54f6fa61c/documents/fae42660-8944-431b-8543-cf951870a94d_6286a54f-e3c1-4ed5-84fe-ba8ad75dc65f.html,,,,,, Dodecaaluminium trimolybdenum dodecaoxide,15123-80-5,"Read-across with molybdenum trioxide:Molybdenum trioxide showed low systemic toxicity regarding repeated dose toxicity.Read-across with aluminium compounds:Various aluminium compounds showed modest evidence of systemic toxicity regarding repeated dose toxicity. However, the effects were judged to be supported by either limited evidence or no clear evidence at all. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8010731e-1135-4311-91d4-7076e238b723/documents/IUC5-b00ad4f6-ea28-4e99-9171-ac3ab7ea7aa5_a4371bc0-f266-4f94-8e72-a21486320289.html,,,,,, Dodecaaluminium trimolybdenum dodecaoxide,15123-80-5,"Oral (OECD 423), rat: LD50 = 5000 mg/kg bw (cut-off value)Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw (limit test)Read across with molybdenum compounds:Inhalation (OECD 403 ), rat: LC50 > 5 mg/LRead across with fumed alumina:Inhalation (OECD 403 ), rat: LC50 > 2.3 mg/L ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8010731e-1135-4311-91d4-7076e238b723/documents/IUC5-d97cbe5a-9925-4984-82e6-c37401525db8_a4371bc0-f266-4f94-8e72-a21486320289.html,,,,,, Dodecaaluminium trimolybdenum dodecaoxide,15123-80-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8010731e-1135-4311-91d4-7076e238b723/documents/IUC5-d97cbe5a-9925-4984-82e6-c37401525db8_a4371bc0-f266-4f94-8e72-a21486320289.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Dodecaaluminium trimolybdenum dodecaoxide,15123-80-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8010731e-1135-4311-91d4-7076e238b723/documents/IUC5-d97cbe5a-9925-4984-82e6-c37401525db8_a4371bc0-f266-4f94-8e72-a21486320289.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dodecairon strontium nonadecaoxide,12023-91-5,"A 28 days toxicity study or a 90 days toxicity study for the oral and the dermal route are not required as the inhalation route is considered to be the most appropriate route of administration. However, no new study is required because weight of evidence evaluation covers this endpoint sufficiently. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f5ae159-0a81-4a6f-8d65-1ccf73ea5cba/documents/IUC5-a3b93da4-5967-4757-a3b2-9de64f9e907c_98130df7-5199-493f-a073-98bc86418a87.html,,,,,, Dodecairon strontium nonadecaoxide,12023-91-5,Oral: LD50 > 2000 mg/kg b.w.Dermal: LD50 > 2000 mg/kg b.w.Inhalation: LD50 > 5 mg/LNo acute toxicity was observed up to the maximum achievable test concentration. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f5ae159-0a81-4a6f-8d65-1ccf73ea5cba/documents/IUC5-9b97754f-6313-40f7-b476-1c770ac6db84_98130df7-5199-493f-a073-98bc86418a87.html,,,,,, Dodecairon strontium nonadecaoxide,12023-91-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f5ae159-0a81-4a6f-8d65-1ccf73ea5cba/documents/IUC5-9b97754f-6313-40f7-b476-1c770ac6db84_98130df7-5199-493f-a073-98bc86418a87.html,,oral,discriminating dose,"2,000 mg/kg bw",, Dodecairon strontium nonadecaoxide,12023-91-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f5ae159-0a81-4a6f-8d65-1ccf73ea5cba/documents/IUC5-9b97754f-6313-40f7-b476-1c770ac6db84_98130df7-5199-493f-a073-98bc86418a87.html,,dermal,discriminating dose,"2,000 mg/kg bw",, Dodecairon strontium nonadecaoxide,12023-91-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f5ae159-0a81-4a6f-8d65-1ccf73ea5cba/documents/IUC5-9b97754f-6313-40f7-b476-1c770ac6db84_98130df7-5199-493f-a073-98bc86418a87.html,,inhalation,discriminating conc.,"5,000 mg/m3",, Dodecamethylenediamine,2783-17-7," in literature, some data on acute toxicity is present. Acute Toxicity Data Journal of the American College of Toxicology, Part B. (Mary Ann Liebert, Inc., 1651 Third Ave., New York, NY 10128) V.1- 1990- states an LDlo (oral, rat) of 670 mg/kg Inhalation Toxicology (Published by Taylor & Francis Health, 11 New Fetter Lane, London EC4P 4EE) V.1- 1989- states an LD50 (inhalation, rat, 4h) 680 mg/m3 However, as the substance is classified as skin corrosive, cat. 1, no study is reported. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd9df547-022a-4d54-913b-d1b5517e0b53/documents/eff7b58e-6a40-4f3d-b3be-93ef9d708b2c_3dd41b3e-e311-483f-a5bb-5d28327b9ccb.html,,,,,, Dodecamethylenediamine,2783-17-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd9df547-022a-4d54-913b-d1b5517e0b53/documents/eff7b58e-6a40-4f3d-b3be-93ef9d708b2c_3dd41b3e-e311-483f-a5bb-5d28327b9ccb.html,,oral,discriminating dose,670 mg/kg bw,adverse effect observed, Dodecamethylenediamine,2783-17-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd9df547-022a-4d54-913b-d1b5517e0b53/documents/eff7b58e-6a40-4f3d-b3be-93ef9d708b2c_3dd41b3e-e311-483f-a5bb-5d28327b9ccb.html,,inhalation,LC50,680 mg/m3,adverse effect observed, Dodecamethylpentasiloxane,141-63-9,"In the key 90-day repeated dose oral toxicity study conducted according to OECD Test Guideline 408 and in compliance with GLP (Charles River Laboratories, 2023, reliability 1), dodecamethylpethylsiloxane (L5, CAS 141-63-9; EC 25-492-2) was administered neat by oral gavage at doses of 100, 300 and 1000 mg/kg bw/ day. A control group was administered Elix® reverse osmosis water.  Based on the lack of systemic adverse effects in males and females a systemic NOAEL for dodecamethylpentasiloxane was established to be ≥1000 mg/kg bw/day for both males and females. Based on the mortality observed in males and females at 1000 mg/kg bw/day, which was likely related to the unintended presence of the test material in the lung due to gavage-related reflux, a local NOAEL was established to be 300 mg/kg bw/day for both sexes. However, since this local NOAEL concluded by the laboratory is not point of contact, it is not used in the assessment of the registered substance.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f5c6db9-5324-4f7e-a973-017897893a21/documents/4c92f6de-5453-472f-bae6-04900d5f2c29_1cd4198e-8b9d-492e-a9bf-43f0b8896cec.html,,,,,, Dodecamethylpentasiloxane,141-63-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f5c6db9-5324-4f7e-a973-017897893a21/documents/4c92f6de-5453-472f-bae6-04900d5f2c29_1cd4198e-8b9d-492e-a9bf-43f0b8896cec.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dodecamethylpentasiloxane,141-63-9,"All available key data for linear siloxanes have been included to the dataset for the registered substance, L5 (dodecamethylpentasiloxane, CAS 141-63-9) to assess the acute oral and inhalation toxicity endpoints. The key studies were selected as they were conducted for the linear siloxane with the closest chain length. There are key acute dermal toxicity data available for L5, therefore data for the other linear siloxanes have been included as supporting for consistency and to support read across justifications.   Acute oral toxicity key study   L3: In the acute oral toxicity study with L3 (octamethyltrisiloxane, CAS 107-51-7), conducted according to an appropriate OECD Test Guideline 423 and in compliance with GLP, an LD50 value of greater than 2000 mg/kg was concluded (Dow Corning Corporation, 2004a).   Acute inhalation toxicity key study     L3: The acute inhalation toxicity study with L3 (octamethyltrisiloxane, CAS 107-51-7), conducted according to OECD Test Guideline 403 and in compliance with GLP, exposed rats to a test atmosphere of vapour and determined an LC50 value of greater than 22.6 mg/l (analytical) (Dow Corning Corporation, 2004b).     Acute dermal toxicity key study     L5: In the key acute dermal toxicity study with L5 ( dodecamethylpentasiloxane, CAS 141-63-9), conducted according to OECD Test Guideline 402 and in compliance with GLP, an LD50 value was determined to be greater than 2000 mg/kg bw (Dow Corning Corporation, 2009a). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f5c6db9-5324-4f7e-a973-017897893a21/documents/7a1a29fd-2ecc-40fc-8572-1b272d45d96d_1cd4198e-8b9d-492e-a9bf-43f0b8896cec.html,,,,,, Dodecamethylpentasiloxane,141-63-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f5c6db9-5324-4f7e-a973-017897893a21/documents/7a1a29fd-2ecc-40fc-8572-1b272d45d96d_1cd4198e-8b9d-492e-a9bf-43f0b8896cec.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Dodecamethylpentasiloxane,141-63-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f5c6db9-5324-4f7e-a973-017897893a21/documents/7a1a29fd-2ecc-40fc-8572-1b272d45d96d_1cd4198e-8b9d-492e-a9bf-43f0b8896cec.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Dodecamethylpentasiloxane,141-63-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f5c6db9-5324-4f7e-a973-017897893a21/documents/7a1a29fd-2ecc-40fc-8572-1b272d45d96d_1cd4198e-8b9d-492e-a9bf-43f0b8896cec.html,,inhalation,LC50,"> 22,600 mg/m3",no adverse effect observed, "N,N-dibutyldodecanamide",5343-44-2,Acute toxicity: oral - Effect level LD50 in mg/kg bw >2000Acute toxicity: dermal - Effect level LD50 in mg/kg bw >2000 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa5c25a8-f089-4cc1-acd6-7bc92057dea7/documents/IUC5-2c855e44-6a0d-463b-ac6c-789e158618b0_93dbacfd-5af8-427c-bb4e-7e66d0f15024.html,,,,,, "N,N-dibutyldodecanamide",5343-44-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa5c25a8-f089-4cc1-acd6-7bc92057dea7/documents/IUC5-2c855e44-6a0d-463b-ac6c-789e158618b0_93dbacfd-5af8-427c-bb4e-7e66d0f15024.html,,oral,LD50,"2,000 mg/kg bw",, "N,N-dibutyldodecanamide",5343-44-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa5c25a8-f089-4cc1-acd6-7bc92057dea7/documents/IUC5-2c855e44-6a0d-463b-ac6c-789e158618b0_93dbacfd-5af8-427c-bb4e-7e66d0f15024.html,,dermal,LD50,"2,000 mg/kg bw",, "Dodecane-1,12-diol",5675-51-4," Ten male and ten female Wistar Han rats per group were treated with the test substance by daily oral gavage at dose levels of 100, 300 and 1000 mg/kg according to OECD TG 422. The control group received the vehicle propylene glycol alone. Males were treated for > 28 days, including at least 2 weeks prior to mating, during mating, and up to termination (29 to 33 days). Females that delivered were treated for 51-55 days, i.e. 14 days prior to mating (with the objective to cover at least two complete estrous cycles), the variable time to conception, the duration of pregnancy and 13 to15 days after delivery, up to and including the day before scheduled necropsy. Formulation analyses confirmed that formulations of test item in propylene glycol were prepared accurately and homogenously. There were two unscheduled deaths, both not test item-related.  One control female died on Day 32 due to a gavage-related incident and one female at 300 mg/kg/day was sacrificed in extremis on Day 39 due to parturition difficulties. No test item-related changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations (motor activity, grip strength, hearing ability, pupillary reflex and static righting reflex), body weight, food consumption, clinical laboratory investigations (hematology, clotting parameters, clinical biochemistry (including male T4 thyroid hormone levels)), macroscopic examination, organ weights, and microscopic examination). In conclusion, based on the results of this combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the Parental No Observed Adverse Effect Levels (NOAEL) for 1,12-Dodecanediol was established to be at least 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc071b06-1d0d-483b-9270-0fa23cb3ce0b/documents/2b031c33-eeee-4b79-b72a-a52ed64d135b_37150485-963b-4c32-8c56-6a6d3594592a.html,,,,,, "Dodecane-1,12-diol",5675-51-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc071b06-1d0d-483b-9270-0fa23cb3ce0b/documents/2b031c33-eeee-4b79-b72a-a52ed64d135b_37150485-963b-4c32-8c56-6a6d3594592a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Dodecane-1,12-diol",5675-51-4,The acute oral LD50 in rats is determined with >10000 mg/kg bw based on the results of a study performed according to OECD TG 401. No deaths occurred. The test doses up to and including 1000 mg/kg bw resulted in reversible clinical signs. No clinical signs were observed from test day 10 until the end of the study. All animals gained the expected body weight and no gross pathological findings were recorded. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc071b06-1d0d-483b-9270-0fa23cb3ce0b/documents/452bea58-fd24-41bd-98b9-4068fccb0284_37150485-963b-4c32-8c56-6a6d3594592a.html,,,,,, "Dodecane-1,12-diol",5675-51-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc071b06-1d0d-483b-9270-0fa23cb3ce0b/documents/452bea58-fd24-41bd-98b9-4068fccb0284_37150485-963b-4c32-8c56-6a6d3594592a.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, Dodecane-12-lactam,947-04-6,"In a 90-day gavage study with rats, administration of dodecane-12-lactam at doses up to and including 25 mg/kg bw/day did not result in adverse effects (= NOAEL). At 125 mg/kg bw/day, blood examination revealed a slight increase in total serum protein and albumin levels in females and a moderate increase in potassium levels in males. Sodium excretion was also increased in males. In a few males treated with 25 or 125 mg/kg bw/day slight morphological changes in centrilobular hepatocytes (ground glass appearance) were noted, but this effect was reversible 4 weeks post-exposure, and in the absence of any other sign of liver toxicity was considered adaptive rather than adverse. No histopathological changes were found in the reproductive organs of these animals. In a subchronic study with dogs, administration of lauryl lactam (dodecane-12-lactam) with the feed at a dose of 44 mg/kg bw/day (males) and 49 mg/kg bw/day (females), respectively, was not associated with adverse effects (= NOAEL), whilst a daily dose of 350 mg/kg bw (males) and 352 mg/kg bw (females), respectively, resulted in a significant increase in liver weight (up to +34 % relative to the controls). The top dose of 969 mg/kg bw/day (males) and 989 mg/kg bw/day (females), respectively, severely affected the general health conditions of the animals and was lethal for one female. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6131f15-6a2f-4922-b09d-f07d8928ec16/documents/IUC5-e06f5c39-d194-4548-aeb1-0ca1e995c11f_84238f69-0f48-4bd0-a26a-32fcac552bf5.html,,,,,, Dodecane-12-lactam,947-04-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6131f15-6a2f-4922-b09d-f07d8928ec16/documents/IUC5-e06f5c39-d194-4548-aeb1-0ca1e995c11f_84238f69-0f48-4bd0-a26a-32fcac552bf5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,, Dodecane-12-lactam,947-04-6,"The acute oral LD50 was 2,330 mg/kg bw (rat) with central nervous system stimulation (trembling, convulsive twitches, ataxia) as the main clinical sign appearing at about 1,580 mg/kg bw. The dermal LD50 was greater than 2,000 mg/kg bw (rat). Decreased food consumption and stagnation of body weight development were noted. Valid acute inhalation studies in rats are not available.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6131f15-6a2f-4922-b09d-f07d8928ec16/documents/IUC5-46818b38-16f8-4857-ad95-b8ec5072f8e7_84238f69-0f48-4bd0-a26a-32fcac552bf5.html,,,,,, Dodecane-12-lactam,947-04-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6131f15-6a2f-4922-b09d-f07d8928ec16/documents/IUC5-46818b38-16f8-4857-ad95-b8ec5072f8e7_84238f69-0f48-4bd0-a26a-32fcac552bf5.html,,oral,LD50,"2,330 mg/kg bw",no adverse effect observed, Dodecane-12-lactam,947-04-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6131f15-6a2f-4922-b09d-f07d8928ec16/documents/IUC5-46818b38-16f8-4857-ad95-b8ec5072f8e7_84238f69-0f48-4bd0-a26a-32fcac552bf5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,6-Bis-[(2,2-dimethyl-3-lauroyloxy-propylidene)-amino]hexane",613222-52-9," SIKA Hardener LH was tested for repeated dose toxicity in a 90 day oral gavage test according to OECD guideline 408. Under the conditions of the present study, 1000 mg/kg bw/day dose of SIKA Hardener LH induced alterations in the spleen in the form of macroscopically enlargement associated with changes in some parameters of hematology (white blood cells, eosinophilic granulocytes and reticulocytes) or clinical chemistry (aspartate aminotransferase and total bilirubin) and increase in spleen weight accompanied by splenic hyperplasia (erythroid, myeloid and lymphoid) in female animals after consecutive 90-day oral (gavage) administration to Hsd.Han:Wistar rats. Splenic alterations were considered to be reversible although minor changes in the spleen weight were detected in female animals without any related histological alteration at the end of the recovery period. There were no toxicologically relevant changes in the examined parameters in male or female animals at 300 mg/kg bw/day or at 100 mg/kg bw/day. Based on these observations the No Observed Adverse Effect Level (NOAEL) was determined as follows: NOAEL: 1000 mg/kg bw/day for male Hsd.Han:Wistar rats NOAEL: 300 mg/kg bw/day for female Hsd.Han:Wistar rats. Repeated dose toxicity testing via the dermal route and inhalation route was waived, according to the REACH Regulation (EC) No 1907/2006, Annex VIII, 8.6.1. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c6856fe-cb03-4b0c-bfc0-7d9c0f8eb185/documents/ea871488-6721-422b-b6a9-0d1324460685_8d544726-7684-4a75-b2e6-36e686045e3e.html,,,,,, "1,6-Bis-[(2,2-dimethyl-3-lauroyloxy-propylidene)-amino]hexane",613222-52-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c6856fe-cb03-4b0c-bfc0-7d9c0f8eb185/documents/ea871488-6721-422b-b6a9-0d1324460685_8d544726-7684-4a75-b2e6-36e686045e3e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "1,6-Bis-[(2,2-dimethyl-3-lauroyloxy-propylidene)-amino]hexane",613222-52-9,"SIKA Hardener LH is the reaction product of the two substances 2,2-Dimethyl-3-lauroyloxy-propanal (CAS no. 102985-93-3, EINECS no. 468-880-2) and Hexamethylenediamine (CAS no. 124-09-4, EINECS no. 204-679-6). Upon contact with water SIKA Hardener LH rapidly hydrolyses, re-forming the original reactants as degradation products, i.e. the aldehyde and amine component. As agreed with the German Authorities (Bundesanstalt für Arbeitsschutz und Arbeitsmedizin, BAuA, see IUCLID section 13) the tests on acute oral and acute dermal toxicity were waived for animal welfare reasons. Instead, available data for hydrolytic degradation products 2,2-Dimethyl-3-lauroyloxy-propanal and Hexamethlendiamine are provided. Testing via the inhalation route was waived, according to REACH Regulation 1907/2006/EEC, Annex VIII, 8.5.2. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP and guideline conform study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): GLP and guideline conform study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c6856fe-cb03-4b0c-bfc0-7d9c0f8eb185/documents/72113e77-1f1b-4662-87a0-6f52993b988b_8d544726-7684-4a75-b2e6-36e686045e3e.html,,,,,, "1,6-Bis-[(2,2-dimethyl-3-lauroyloxy-propylidene)-amino]hexane",613222-52-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c6856fe-cb03-4b0c-bfc0-7d9c0f8eb185/documents/72113e77-1f1b-4662-87a0-6f52993b988b_8d544726-7684-4a75-b2e6-36e686045e3e.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "1,6-Bis-[(2,2-dimethyl-3-lauroyloxy-propylidene)-amino]hexane",613222-52-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c6856fe-cb03-4b0c-bfc0-7d9c0f8eb185/documents/72113e77-1f1b-4662-87a0-6f52993b988b_8d544726-7684-4a75-b2e6-36e686045e3e.html,,dermal,discriminating dose,"2,000 mg/kg bw",adverse effect observed, Sodium 2-(dodecanoyloxy)propane-1-sulfonate,156572-81-5,"In a 90d oral study on rats (Zhejiang, 2011) the read across material Sodium Decyl Methyl Isethionate achieved an NOAEL of 123.63 mg/kg bw/day in females and 111.19 mg/kg bw/day in males. In a 90d oral study on rats (Braun, 2009) the read across material Sodium Isethionate acheived a NOAEL of 200mg/kg bw/d; 426mg/kg bw/d (converted to SLMI)In a 28d oral study on rats (Lea, 1995) the read across material Sodium Coco Isethionate acheived a NOAEL of 1000mg/kg bw/d; 1092mg/kg bw/d (converted to SLMI)In a 28d dermal study on rats (Greico, 1991) the read across material Sodium Coco Isethionate acheived a NOAEL of 2070mg/kg bw/d; 2260mg/kg bw/d (conerted to SLMI) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d0ca6a2-1523-47c0-9b40-a339f49fb4db/documents/IUC5-275e19df-d311-4755-a697-5383f9705342_7428b95e-e83b-4c46-929a-542c5c077c16.html,,,,,, Sodium 2-(dodecanoyloxy)propane-1-sulfonate,156572-81-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d0ca6a2-1523-47c0-9b40-a339f49fb4db/documents/IUC5-275e19df-d311-4755-a697-5383f9705342_7428b95e-e83b-4c46-929a-542c5c077c16.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,260 mg/kg bw/day",,rat Sodium 2-(dodecanoyloxy)propane-1-sulfonate,156572-81-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d0ca6a2-1523-47c0-9b40-a339f49fb4db/documents/IUC5-275e19df-d311-4755-a697-5383f9705342_7428b95e-e83b-4c46-929a-542c5c077c16.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,111 mg/kg bw/day,,rat Sodium 2-(dodecanoyloxy)propane-1-sulfonate,156572-81-5, In an klimsch score 2 study on SCI an LD50 (oral) of >5000 mg/kg/bw was achieved In an klimsch score 2 study on SLI an LD50 (dermal) of >2000 mg/kg/bw was achieved ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d0ca6a2-1523-47c0-9b40-a339f49fb4db/documents/IUC5-8782d026-cf58-4d11-8a43-8354758de684_7428b95e-e83b-4c46-929a-542c5c077c16.html,,,,,, Sodium 2-(dodecanoyloxy)propane-1-sulfonate,156572-81-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d0ca6a2-1523-47c0-9b40-a339f49fb4db/documents/IUC5-8782d026-cf58-4d11-8a43-8354758de684_7428b95e-e83b-4c46-929a-542c5c077c16.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium 2-(dodecanoyloxy)propane-1-sulfonate,156572-81-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d0ca6a2-1523-47c0-9b40-a339f49fb4db/documents/IUC5-8782d026-cf58-4d11-8a43-8354758de684_7428b95e-e83b-4c46-929a-542c5c077c16.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2-dimethyl-3-oxopropyl dodecanoate",102985-93-3,"Based on the results of the 90-day repeated dose study, the NOAEL was determined to be 300 mg/kg bw/d for male and female Wistar rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP and guideline study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7aee04e6-2aa4-4847-b37b-c031beb06406/documents/6e43f472-0e9f-4a97-b32b-180024ebe951_b409aa7f-7a3f-41e1-83c4-c969620bc4d2.html,,,,,, "2,2-dimethyl-3-oxopropyl dodecanoate",102985-93-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7aee04e6-2aa4-4847-b37b-c031beb06406/documents/6e43f472-0e9f-4a97-b32b-180024ebe951_b409aa7f-7a3f-41e1-83c4-c969620bc4d2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2,2-dimethyl-3-oxopropyl dodecanoate",102985-93-3,"2,2-Dimethyl-3-lauroyloxy-propanal showed an acute oral toxicity greater than 2000 mg/kg bw in rats. The acute dermal toxicity of  2,2-Dimethyl-3-lauroyloxy-propanal was found  to be greater than 2000 mg/kg bw in rats. Testing on inhalation toxicity was waived, as data on oral and dermal toxicity are available. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP and guideline conform study. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): GLP and guideline study. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7aee04e6-2aa4-4847-b37b-c031beb06406/documents/28f245f3-abe7-4ebd-aa57-923aac9e75d0_b409aa7f-7a3f-41e1-83c4-c969620bc4d2.html,,,,,, "2,2-dimethyl-3-oxopropyl dodecanoate",102985-93-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7aee04e6-2aa4-4847-b37b-c031beb06406/documents/28f245f3-abe7-4ebd-aa57-923aac9e75d0_b409aa7f-7a3f-41e1-83c4-c969620bc4d2.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2,2-dimethyl-3-oxopropyl dodecanoate",102985-93-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7aee04e6-2aa4-4847-b37b-c031beb06406/documents/28f245f3-abe7-4ebd-aa57-923aac9e75d0_b409aa7f-7a3f-41e1-83c4-c969620bc4d2.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3-(2-(2-Hydroxyethoxy)ethylimino)-2,2-dimethylpropyl dodecanoate",931419-77-1, Sika Hardener LG was examined in one acute oral study in rats. No treatment related effects were observed and LD0 and LD 50-values determined at 2000 mg/kg bw (limit dose).  ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/718291ab-a80a-4a17-b34c-6126cbb63735/documents/72bbc4f6-9d91-4829-a4f2-07cd9cff6dfe_4240c567-0637-433e-87a5-9af0b46f2376.html,,,,,, "3-(2-(2-Hydroxyethoxy)ethylimino)-2,2-dimethylpropyl dodecanoate",931419-77-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/718291ab-a80a-4a17-b34c-6126cbb63735/documents/72bbc4f6-9d91-4829-a4f2-07cd9cff6dfe_4240c567-0637-433e-87a5-9af0b46f2376.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "3-((5-(3-(Dodecanoyloxy)-2,2-dimethylpropylideneamino)-1,3,3-trimethylcyclohexyl)methylimino)-2,2-dimethylpropyl dodecanoate",932742-30-8,"A repeated toxicity oral study with the test item SIKA Hardener LI was performed according to OECD guideline 408. The derived no observed adverse effect level (NOAEL) was 300 mg/kg bw/day. Testing via inhalation and dermal routes was waived, according to the REACH Regulation (EC) No 1907/2006/EEC, Annex VIII, 8.6.1. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13d289c0-79b2-4cba-869c-cead1d81d5a2/documents/IUC5-6e286052-dc6a-4eee-b184-c2aaa85f9db8_1f404c90-2d06-4bde-b1f3-1c599b8d9b80.html,,,,,, "3-((5-(3-(Dodecanoyloxy)-2,2-dimethylpropylideneamino)-1,3,3-trimethylcyclohexyl)methylimino)-2,2-dimethylpropyl dodecanoate",932742-30-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13d289c0-79b2-4cba-869c-cead1d81d5a2/documents/IUC5-6e286052-dc6a-4eee-b184-c2aaa85f9db8_1f404c90-2d06-4bde-b1f3-1c599b8d9b80.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "3-((5-(3-(Dodecanoyloxy)-2,2-dimethylpropylideneamino)-1,3,3-trimethylcyclohexyl)methylimino)-2,2-dimethylpropyl dodecanoate",932742-30-8,"SIKA Hardener LI was tested in an acute oral toxicity study according to EU method B.1tris and OECD guideline 423. No treatment related effects were observed up to dose levels of 2000 mg/kg bw. The LD50-value was greater 2000 mg/kg bw and the NOEL 2000 mg/kg bw. SIKA Hardener LI was tested in an acute dermal toxicity study according to EU method B.3 and OECD guideline 402. No treatment related effects were observed up to dose levels of 2000 mg/kg bw. The LD50-value was greater 2000 mg/kg bw and the NOEL 2000 mg/kg bw. Testing via the inhalation route was waived, according to REACH Regulation (EC) No 1907/2006, Annex VIII, 8.5.2. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13d289c0-79b2-4cba-869c-cead1d81d5a2/documents/IUC5-a6a208da-50c3-4143-8a3f-d5699e614ba2_1f404c90-2d06-4bde-b1f3-1c599b8d9b80.html,,,,,, "3-((5-(3-(Dodecanoyloxy)-2,2-dimethylpropylideneamino)-1,3,3-trimethylcyclohexyl)methylimino)-2,2-dimethylpropyl dodecanoate",932742-30-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13d289c0-79b2-4cba-869c-cead1d81d5a2/documents/IUC5-a6a208da-50c3-4143-8a3f-d5699e614ba2_1f404c90-2d06-4bde-b1f3-1c599b8d9b80.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3-((5-(3-(Dodecanoyloxy)-2,2-dimethylpropylideneamino)-1,3,3-trimethylcyclohexyl)methylimino)-2,2-dimethylpropyl dodecanoate",932742-30-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13d289c0-79b2-4cba-869c-cead1d81d5a2/documents/IUC5-a6a208da-50c3-4143-8a3f-d5699e614ba2_1f404c90-2d06-4bde-b1f3-1c599b8d9b80.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Dodecanoic acid, ester with 1,2,3-propanetriol",37318-95-9," Oral, rat (read-across OECD 422): NOAEL = 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da4fd0f3-da56-4bd6-b359-361bc23d3c10/documents/c54215d2-7d49-4d1d-bfb9-ee3b6c16bd67_5626b855-8254-4b2b-b2d4-27241f48aa45.html,,,,,, "Dodecanoic acid, ester with 1,2,3-propanetriol",37318-95-9, Oral (read-across OECD 401): LD50 > 5000.0 mg/kg bw Inhalation (read-across OECD 403): LC50 > 1.86 mg/L air (analytical) Dermal (read-across OECD 402): LD50 > 2000.0 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da4fd0f3-da56-4bd6-b359-361bc23d3c10/documents/5a76c923-922f-4ccc-bde1-189c0d773c6a_5626b855-8254-4b2b-b2d4-27241f48aa45.html,,,,,, "Dodecene, branched",97280-83-6,"There is a 28 day repeat oral dosing study with triisobutylene with 14 day recovery. There are also repeat dose toxicity studies with other higher olefins spanning the range C8 to C20. The data for these studies indicate that the location of the double bond or the addition of branching to the structure do not appear to affect the toxicity. Higher olefins are of low toxicity in rats. Male rat kidney effects indicative of alpha-2u-globulin nephropathy consistently occur with the C8 to C14 higher olefins. Alpha-2u-globulin nephropathy is considered to be male rat-specific and is not relevant for humans. Treatment-related liver effects (increased organ weights, hepatocyte cytoplasmic vacuolation, and centrilobular hepatocyte hypertrophy) are also observed in rats exposed to higher olefins, which may reflect adaptive changes as a result of the high liver burden of these substances. There is no evidence of neurotoxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/abd97699-df4b-468a-b368-138c5f0acc2d/documents/IUC5-ae181e9c-6f53-45e7-b0bd-f6a8521b6ae7_6704f681-6f2f-40be-ba60-b53f4811eb93.html,,,,,, "Dodecene, branched",97280-83-6,"Acute toxicity studies exist for higher olefins including butylene oligomers at both ends of the carbon number ranges within this category. The results are consistent throughout the category and indicate low acute toxicity by the oral, dermal and inhalation routes of exposure. Butylene oligomers have low kinematic viscosity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abd97699-df4b-468a-b368-138c5f0acc2d/documents/IUC5-8b0e8e36-1e21-4ab5-a872-e336ab2f055c_6704f681-6f2f-40be-ba60-b53f4811eb93.html,,,,,, "Dodecene, hydroformylation products, high-boiling",68526-91-0,"Rat, oral 28 day study: NOAEL (male) = 300 mg/kg bw; NOAEL (female) = 1000 mg/kg bw (GLP, OECD 407, BASF SE, 2010) ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/76c90c7d-2e19-4dcc-ad29-7ee31a730fa5/documents/IUC5-11cdcb07-8880-40ff-a26b-cc3fc2ceb21a_2fb57aba-3d07-4238-9c37-eaeee7a73f29.html,,,,,, "Dodecene, hydroformylation products, high-boiling",68526-91-0,"oral rat: LD50 > 5000 mg/kg bw; no signs of toxicity (non-GLP, OECD 401; BASF AG, 1982) dermal rat: LD50 > 2000 mg/kg bw; no signs of toxicity (GLP, OECD 402; BASF SE, 2009) inhalation No data available ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76c90c7d-2e19-4dcc-ad29-7ee31a730fa5/documents/IUC5-03a30230-c097-4d66-ba70-a6f8fd1894b2_2fb57aba-3d07-4238-9c37-eaeee7a73f29.html,,,,,, "Dodecene, hydroformylation products, low-boiling",68526-92-1," A repeated dose 90 -day oral toxicity study of oxooil LS13 in rats was conducted. The aim of the experiment was to obtain information on the toxicity of Oxooil LS13 given to rats by daily oral administration via gavage at dose levels of 100, 300 or 1000 mg/kg b.w./day for 90 days. The experimental no-observed-adverse-effect level (NOAEL) was 300 mg Oxooil LS13/kg b.w. by daily oral administration, in particular, as no test item-related changes were noted at histopathological examination. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b6ffe69-5b59-4f61-a732-2cf59a13de7f/documents/9445452b-fb00-4424-8290-57d461f56841_af7f03a1-06e4-4a1b-994a-f760946c0925.html,,,,,, "Dodecene, hydroformylation products, low-boiling",68526-92-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b6ffe69-5b59-4f61-a732-2cf59a13de7f/documents/9445452b-fb00-4424-8290-57d461f56841_af7f03a1-06e4-4a1b-994a-f760946c0925.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Dodecene, hydroformylation products, low-boiling",68526-92-1,"Two acute toxicity tests were conducted, an oral and a dermal study. For both exposure routes, the acute oral median lethal dose (LD50) of the test material in rats was estimated to be greater than 2000 mg/kg bodyweight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b6ffe69-5b59-4f61-a732-2cf59a13de7f/documents/662a87b2-7e5a-4cc9-be15-ac890049972c_af7f03a1-06e4-4a1b-994a-f760946c0925.html,,,,,, "Dodecene, hydroformylation products, low-boiling",68526-92-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b6ffe69-5b59-4f61-a732-2cf59a13de7f/documents/662a87b2-7e5a-4cc9-be15-ac890049972c_af7f03a1-06e4-4a1b-994a-f760946c0925.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Dodecene, hydroformylation products, low-boiling",68526-92-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b6ffe69-5b59-4f61-a732-2cf59a13de7f/documents/662a87b2-7e5a-4cc9-be15-ac890049972c_af7f03a1-06e4-4a1b-994a-f760946c0925.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Dodecyl nonan-1-oate,17671-26-0," Oral: (OECD 407 and OECD 422, read across) NOAEL rat: 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92815a17-fc5e-4ae2-89e4-a5b09056f54c/documents/1395a15e-2b71-4012-81fd-3a8739663bf1_4db77083-dc7c-4e8a-a5a8-b90be088d8f8.html,,,,,, Dodecyl nonan-1-oate,17671-26-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92815a17-fc5e-4ae2-89e4-a5b09056f54c/documents/1395a15e-2b71-4012-81fd-3a8739663bf1_4db77083-dc7c-4e8a-a5a8-b90be088d8f8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dodecyl nonan-1-oate,17671-26-0," Oral (equivalent to OECD 401, read across): LD50 rat ≥ 5000 mg/kg bw Dermal (OECD 402, read across): LD50 rat > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92815a17-fc5e-4ae2-89e4-a5b09056f54c/documents/856de01f-966c-4d86-8ede-54bac497a04f_4db77083-dc7c-4e8a-a5a8-b90be088d8f8.html,,,,,, "Dodecylbenzenesulphonic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)",37475-84-6," In a study according to OECD 422, oral administration of dodecylbenzenesulfonic acid to rats resulted in soft faeces, and squamous cell hyperplasia of stomach in both sexes at 400 mg/kg bw/day, and liquid faeces and soled perineal region, a decrease in body weight and food consumption in males at 400 mg/kg bw/day. In histopathology examination, squamous cell hyperplasia of stomach was observed in both sexes at 200 mg/kg bw/day and forestomach erosion/ulcer was observed in males at 400mg/kg bw/day. Based on these effects the NOAEL value was 100 mg/kg bw/day for male and female rats and the LOAEL value was 200 mg/kg bw/day for male and female rats. From these results, the target organ for oral dosing of dodecylbenzenesulfonic acid was considered to be the stomach. On AMP oral repeated dose studies are available in dogs (maximum concentrations in diet tested 2.8 and 62.5 mg/kg bw) and rats (90-day diet NOAEL 25 mg/kg bw). The effects seen in both species are in the liver which can be related to an effect on choline synthesis, but a clear species difference becomes apparent with the dog being more sensitive (chronic NOAEL2.8 mg/kg bw). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ae10af9-7798-4d8c-be08-742ccc0366d1/documents/773125d0-c94e-4f10-bc29-64fa27832604_9bd374ee-fbd0-44db-9894-e26b930761a0.html,,,,,, "Dodecylbenzenesulphonic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)",37475-84-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ae10af9-7798-4d8c-be08-742ccc0366d1/documents/773125d0-c94e-4f10-bc29-64fa27832604_9bd374ee-fbd0-44db-9894-e26b930761a0.html,Chronic toxicity – systemic effects,oral,NOAEL,13.3 mg/kg bw/day,,dog "Dodecylbenzenesulphonic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)",37475-84-6," For DDBSA the acute oral LD50 in male/female rats is 775 mg/kg bw. LD50 value is geometric mean between 300 and 2000 mg/kg. In an acute oral study on AMP in rats, doses exceeding 2800 mg/kg orally resulted in rapid absorption into the circulatory system resulting in gross damage to the liver, kidney, spleen, and respiratory system followed by respiratory collapse. The compound produces irritation to the stomach and duodenum at doses of 2800 mg/kg and greater. The LD50 was calculated to be 2900 mg/kg bw. The clipped skin on the backs of five male and five female rats was exposed to the sodium salt of DDBSA under an occlusive dressing for 24 hours and observed for another 14 days. Results indicate slight erythema and slight oedema but no acute mortality. The dermal LD50 is > 2000 mg/kg. AMP was applied at doses of 1000, 1500 or 2000 mg/kg bw under an occluded dressing for 24 hours to the shaved skin of rabbits. At the end of 24 hr exposure, thetreated skin sites were severely irritated and black in color. The sites became necrotic within two to three days and remained necrotic for the 1 4 days. The treated sites had severe eschar formation by the 14th day. The rabbits in the three treatment groups lost body weight over the two-week observation period. The animals in all the treated groups showed no signs of toxicity or abnormal pharmacological behavior. At necropsy the organs in all rabbits were grossly normal. The treated skin sites in all the rabbits were necrotic. In conclusion, AMP is dermally nontoxic (LD50 > 2000 mg/kg), but is a severe skin irritant. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae10af9-7798-4d8c-be08-742ccc0366d1/documents/e573495a-6258-4e3d-956f-14c4b571e2b7_9bd374ee-fbd0-44db-9894-e26b930761a0.html,,,,,, "Dodecylbenzenesulphonic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)",37475-84-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae10af9-7798-4d8c-be08-742ccc0366d1/documents/e573495a-6258-4e3d-956f-14c4b571e2b7_9bd374ee-fbd0-44db-9894-e26b930761a0.html,,oral,LD50,910 mg/kg bw,adverse effect observed, "Dodecylbenzenesulphonic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)",37475-84-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae10af9-7798-4d8c-be08-742ccc0366d1/documents/e573495a-6258-4e3d-956f-14c4b571e2b7_9bd374ee-fbd0-44db-9894-e26b930761a0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Dodecyloxirane,3234-28-4,The NOAEL for oral repeated dose toxicity was determined to be 750 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2aab39ea-04e5-4e83-81fc-c4e9c71b562e/documents/IUC5-b70a1147-7612-4193-b59c-5f19e977aeb6_c1a66657-646f-4f58-a572-44126cfb008c.html,,,,,, Dodecyloxirane,3234-28-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2aab39ea-04e5-4e83-81fc-c4e9c71b562e/documents/IUC5-b70a1147-7612-4193-b59c-5f19e977aeb6_c1a66657-646f-4f58-a572-44126cfb008c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat Dodecyloxirane,3234-28-4,The oral LD50 was determined to be >5000 mg/kg bw.The dermal LD50 was determined to be >2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2aab39ea-04e5-4e83-81fc-c4e9c71b562e/documents/IUC5-243da85a-b2d8-40be-8a00-e33c5fe55dc7_c1a66657-646f-4f58-a572-44126cfb008c.html,,,,,, Dodecyloxirane,3234-28-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2aab39ea-04e5-4e83-81fc-c4e9c71b562e/documents/IUC5-243da85a-b2d8-40be-8a00-e33c5fe55dc7_c1a66657-646f-4f58-a572-44126cfb008c.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Dodecyloxirane,3234-28-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2aab39ea-04e5-4e83-81fc-c4e9c71b562e/documents/IUC5-243da85a-b2d8-40be-8a00-e33c5fe55dc7_c1a66657-646f-4f58-a572-44126cfb008c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Dodecylphosphonic acid,5137-70-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The studies are GLP compliant with a high quality (Klimisch score = 1). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/286c1dec-2c82-4f86-be05-5846f5d23efa/documents/7d6cd7da-6ccf-4992-be0c-046e2b196572_70f930b4-c402-4c75-bf79-bb3e435a6101.html,,,,,, Dodecylphosphonic acid,5137-70-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/286c1dec-2c82-4f86-be05-5846f5d23efa/documents/7d6cd7da-6ccf-4992-be0c-046e2b196572_70f930b4-c402-4c75-bf79-bb3e435a6101.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,12 mg/kg bw/day,,rat Dodecylphosphonic acid,5137-70-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): LD50 > 2000 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/286c1dec-2c82-4f86-be05-5846f5d23efa/documents/8ba89f48-871f-48f1-bd06-aa80842bf0f2_70f930b4-c402-4c75-bf79-bb3e435a6101.html,,,,,, "Dolomite (CaMg(CO3)2), calcined",83897-84-1,"Toxicity via the oral route is addressed by upper intake levels (UL) for adults determined by the Scientific Committee on Food (SCF), beingUL = 2500 mg/d, corresponding to 36 mg/kg bw/d (70 kg person) for calciumUL = 250 mg/d, corresponding to 3.6 mg/kg bw/d (70 kg person) for magnesium.Toxicity of CaCO3.MgO via the dermal route is not considered as relevant.Toxicity of CaCO3.MgO via inhalation (local effect, irritation of mucous membranes) is addressed by read-across from an 8-h TWA determined for CaO and Ca(OH)2 by the Scientific Committee on Occupational Exposure Limits (SCOEL) of 1 mg/m³ respirable dust. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30d5f307-7b71-43c7-b2ce-ed51ce4a8b95/documents/IUC5-0c228288-809e-4329-b2f4-6b69c8c1508b_ad82ea3a-caa9-4509-98e1-17092f1e9b69.html,,,,,, "Dolomite (CaMg(CO3)2), calcined",83897-84-1,Calcium magnesium carbonate oxide is not acutely toxic. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30d5f307-7b71-43c7-b2ce-ed51ce4a8b95/documents/IUC5-eea95c01-571c-4361-82bb-320f739ac8a8_ad82ea3a-caa9-4509-98e1-17092f1e9b69.html,,,,,, "Dolomite (CaMg(CO3)2), calcined",83897-84-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30d5f307-7b71-43c7-b2ce-ed51ce4a8b95/documents/IUC5-eea95c01-571c-4361-82bb-320f739ac8a8_ad82ea3a-caa9-4509-98e1-17092f1e9b69.html,,oral,LD50,"2,000 mg/kg bw",, Dore,69029-47-6,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents.     ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3cdc2868-ae0c-446f-8328-6dc54a438881/documents/65a20b63-9941-4c14-bce2-f7f85cdd36be_7c302d55-f72f-4360-80d6-843963a2a119.html,,,,,, Dore,69029-47-6,The acute toxicity is driven by the characteristics of the individual UVCB constituents.     ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cdc2868-ae0c-446f-8328-6dc54a438881/documents/f111965d-0f01-4255-b063-d106b943598e_7c302d55-f72f-4360-80d6-843963a2a119.html,,,,,, Dore,69029-47-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cdc2868-ae0c-446f-8328-6dc54a438881/documents/f111965d-0f01-4255-b063-d106b943598e_7c302d55-f72f-4360-80d6-843963a2a119.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Dore,69029-47-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cdc2868-ae0c-446f-8328-6dc54a438881/documents/f111965d-0f01-4255-b063-d106b943598e_7c302d55-f72f-4360-80d6-843963a2a119.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Dore,69029-47-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cdc2868-ae0c-446f-8328-6dc54a438881/documents/f111965d-0f01-4255-b063-d106b943598e_7c302d55-f72f-4360-80d6-843963a2a119.html,,inhalation,discriminating conc.,"5,000 mg/m3",no adverse effect observed, "Dust, steelmaking",65996-72-7,"The test substance, Dust, steelmaking, was tested for subacute toxicity using the EU method B.7. Repeated Dose (28-days) Toxicity (Oral); the test was performed according to GLP rules. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dfde7a31-389d-4aba-ae98-131457dad4da/documents/IUC5-b60a18bb-b1f2-4af2-aa20-2930cd3c82bd_16af66a3-debb-41e9-b2ad-76821a25c86e.html,,,,,, "Dust, steelmaking",65996-72-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dfde7a31-389d-4aba-ae98-131457dad4da/documents/IUC5-b60a18bb-b1f2-4af2-aa20-2930cd3c82bd_16af66a3-debb-41e9-b2ad-76821a25c86e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Dust, steelmaking",65996-72-7,"The testing of acute oral toxicity was performed according to the Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008. The test substance was administered in a single dose as suspension in vehicle (olive oil), given orally via gavage to two groups of three female Wistar rats. A study was performed in accordance with the OECD Guidelines for Testing of Chemicals (2009) No. 403 “Acute Inhalation Toxicity” and was designed to comply with Method B2 (Inhalation) of Commission Regulation (EC) No. 440/2008, with the exception that only six animals (three males and three females) were utilized during the “limit test”.According to column 2 of REACH Annex VIII, section 8.5 (Acute toxicity) was not carried out the test of acute dermal toxicity (8.5.3) by reason that inhalation exposure by dust of the test material was more probable than exposure by dermal route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfde7a31-389d-4aba-ae98-131457dad4da/documents/IUC5-140855aa-79ba-4393-b25e-30d73aef0376_16af66a3-debb-41e9-b2ad-76821a25c86e.html,,,,,, "Dust, steelmaking",65996-72-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfde7a31-389d-4aba-ae98-131457dad4da/documents/IUC5-140855aa-79ba-4393-b25e-30d73aef0376_16af66a3-debb-41e9-b2ad-76821a25c86e.html,,oral,LD50,"2,000 mg/kg bw",, "Dust, steelmaking",65996-72-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfde7a31-389d-4aba-ae98-131457dad4da/documents/IUC5-140855aa-79ba-4393-b25e-30d73aef0376_16af66a3-debb-41e9-b2ad-76821a25c86e.html,,inhalation,LC50,5.15 mg/m3,, Dysprosium and europium doped strontium dialuminium tetraoxide(monoclinic),201426-52-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb93334f-e650-4bf7-a88e-b6db0ecc85f8/documents/IUC5-64b4a1ee-0b77-4ade-8b5f-854bc8f0883b_86297e01-d1ca-4f51-b7b6-10033472298d.html,,,,,, Dysprosium and europium doped strontium dialuminium tetraoxide(monoclinic),201426-52-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb93334f-e650-4bf7-a88e-b6db0ecc85f8/documents/IUC5-64b4a1ee-0b77-4ade-8b5f-854bc8f0883b_86297e01-d1ca-4f51-b7b6-10033472298d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Dysprosium and europium doped strontium dialuminium tetraoxide(monoclinic),201426-52-0, Acute oral toxicity > 2000 mg / kg bw Acute dermal toxicity > 2000 mg /kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb93334f-e650-4bf7-a88e-b6db0ecc85f8/documents/IUC5-789df93b-c72d-4d2d-b388-23eb319a532d_86297e01-d1ca-4f51-b7b6-10033472298d.html,,,,,, Dysprosium and europium doped strontium dialuminium tetraoxide(monoclinic),201426-52-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb93334f-e650-4bf7-a88e-b6db0ecc85f8/documents/IUC5-789df93b-c72d-4d2d-b388-23eb319a532d_86297e01-d1ca-4f51-b7b6-10033472298d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Dysprosium and europium doped strontium dialuminium tetraoxide(monoclinic),201426-52-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb93334f-e650-4bf7-a88e-b6db0ecc85f8/documents/IUC5-789df93b-c72d-4d2d-b388-23eb319a532d_86297e01-d1ca-4f51-b7b6-10033472298d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Reaction mass of 1-hydroxypropan-2-yl diethylphosphinate and 2-hydroxypropyl diethylphosphinate,2230512-72-6," The following modeling approaches and methods will be used in the analysis: •       OASIS TIMES (AMES, CA, ER, AR) and Catalogic (301C) modeling approach •       Toolbox 4.2 (TB) for searching of analogues and read-across analysis •       Available documented data and expert evaluation ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e32ed67-8bd6-4321-9ab9-e20e42fc8478/documents/39c89188-2083-45b5-8d86-6fc79aed590c_daebccb4-81ff-4f85-8825-80c8e884175a.html,,,,,, Reaction mass of 1-hydroxypropan-2-yl diethylphosphinate and 2-hydroxypropyl diethylphosphinate,2230512-72-6, Acute oral toxicity in Rats Acute dermal toxicity in Rats ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e32ed67-8bd6-4321-9ab9-e20e42fc8478/documents/1c468b04-1261-4dcb-9e38-08f934b6c110_daebccb4-81ff-4f85-8825-80c8e884175a.html,,,,,, Reaction mass of 1-hydroxypropan-2-yl diethylphosphinate and 2-hydroxypropyl diethylphosphinate,2230512-72-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e32ed67-8bd6-4321-9ab9-e20e42fc8478/documents/1c468b04-1261-4dcb-9e38-08f934b6c110_daebccb4-81ff-4f85-8825-80c8e884175a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Reaction mass of 1-hydroxypropan-2-yl diethylphosphinate and 2-hydroxypropyl diethylphosphinate,2230512-72-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e32ed67-8bd6-4321-9ab9-e20e42fc8478/documents/1c468b04-1261-4dcb-9e38-08f934b6c110_daebccb4-81ff-4f85-8825-80c8e884175a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Electrolytes, copper-manufg., spent",69012-54-0,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd425ef1-565a-464f-9149-b346bcddd1c2/documents/d8f8b8f3-ab44-4ec5-9f53-131b191aa45c_74b49d9e-fb15-430e-b06a-c7da3f276651.html,,,,,, "Electrolytes, copper-manufg., spent",69012-54-0,The acute toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd425ef1-565a-464f-9149-b346bcddd1c2/documents/f8e6c97e-c915-4b63-b329-e56c8f3e0c44_74b49d9e-fb15-430e-b06a-c7da3f276651.html,,,,,, Enbucrilate,6606-65-1,"- REACH_LD50 > 5000 mg/kg bw | rat (male/female) | OECD 423 | ethyl-2cyanoacrylate #key study##Analogy# - REACH_negative | mouse (male) | other: ISO 10993-11, Systemic Injection Test | Indermil ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a29372ab-edb1-4e0b-9b36-e8ec183faae3/documents/IUC5-46c4b593-1b64-4dad-9b58-028959eedf13_641cf853-2ae2-445a-92f0-275719ce75b2.html,,,,,, Enbucrilate,6606-65-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a29372ab-edb1-4e0b-9b36-e8ec183faae3/documents/IUC5-46c4b593-1b64-4dad-9b58-028959eedf13_641cf853-2ae2-445a-92f0-275719ce75b2.html,,oral,LD50,"5,000 mg/kg bw",, endo nortropine base,538-09-0, Acute toxicity (oral): LD50rat=1420 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dde08b7c-1858-474d-8d54-4df3ce56fd45/documents/cae903f6-cd39-4485-800a-55299e8cd682_eb2edd34-da6a-45a9-98f8-577bc841ba3d.html,,,,,, endo nortropine base,538-09-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dde08b7c-1858-474d-8d54-4df3ce56fd45/documents/cae903f6-cd39-4485-800a-55299e8cd682_eb2edd34-da6a-45a9-98f8-577bc841ba3d.html,,oral,LD50,"1,420 mg/kg bw",adverse effect observed, Ephedrine hydrochloride,50-98-6,"Based on repeated dosing schemes (NIH, 1986), two chronic carcinogenicity studies with Ephedrine sulfate (read across from analogous substance) were performed in rodents (see chapter 7.7). No evidence for carcinogenicity of the test substance was demonstrated in rats or mice (NIH, 1986). In case of rats (i.e. key study), the NOAEL was >9 mg/kg bw/day (males) and >11 mg/kg bw/day (females). In case of mice (i.e. supporting study), the NOAEL was >29 mg/kg bw/day (males) and >25 mg/kg bw/day (females). Since no adverse and treatment-related carcinogenic effects or other adverse effects were observed in rats, as systemic NOAEL for repeated toxicity 9 mg/kg bw/day is derived based on this reliable chronic study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38d713da-ac7d-4a2f-9f9b-e1ec6a65799a/documents/IUC5-945ccd8e-6a1e-41d2-829f-f96edf588e87_41600818-8e90-4c03-929a-4b0b5e28210c.html,,,,,, Ephedrine hydrochloride,50-98-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38d713da-ac7d-4a2f-9f9b-e1ec6a65799a/documents/IUC5-945ccd8e-6a1e-41d2-829f-f96edf588e87_41600818-8e90-4c03-929a-4b0b5e28210c.html,Chronic toxicity – systemic effects,oral,NOAEL,9 mg/kg bw/day,,rat Ephedrine hydrochloride,50-98-6,Oral: The acute oral LD50 was calculated to be 710 mg/kg bw in rats. Inhalation: The LC50 was determined to be > 5.2 mg/L in rats.Dermal: The acute dermal LD50 was determined to > 2000 mg/kg bw in rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38d713da-ac7d-4a2f-9f9b-e1ec6a65799a/documents/IUC5-f96d00a7-f47d-4adf-92d1-31a61fcdc9f1_41600818-8e90-4c03-929a-4b0b5e28210c.html,,,,,, Ephedrine hydrochloride,50-98-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38d713da-ac7d-4a2f-9f9b-e1ec6a65799a/documents/IUC5-f96d00a7-f47d-4adf-92d1-31a61fcdc9f1_41600818-8e90-4c03-929a-4b0b5e28210c.html,,oral,LD50,710 mg/kg bw,adverse effect observed, Ephedrine hydrochloride,50-98-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38d713da-ac7d-4a2f-9f9b-e1ec6a65799a/documents/IUC5-f96d00a7-f47d-4adf-92d1-31a61fcdc9f1_41600818-8e90-4c03-929a-4b0b5e28210c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Ephedrine hydrochloride,50-98-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38d713da-ac7d-4a2f-9f9b-e1ec6a65799a/documents/IUC5-f96d00a7-f47d-4adf-92d1-31a61fcdc9f1_41600818-8e90-4c03-929a-4b0b5e28210c.html,,inhalation,discriminating conc.,"5,200 mg/m3",no adverse effect observed, EPTC,759-94-4, NOAEL = 3 mg/kg bw ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e7e558b-5a2e-484b-b0bd-88283df48c60/documents/524fb7fa-7b1f-426a-8380-9f0d8d305809_c46aaf95-394a-4769-87bd-bacf6f0c4f1a.html,,,,,, EPTC,759-94-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e7e558b-5a2e-484b-b0bd-88283df48c60/documents/524fb7fa-7b1f-426a-8380-9f0d8d305809_c46aaf95-394a-4769-87bd-bacf6f0c4f1a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,3 mg/kg bw/day,,rat EPTC,759-94-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable rat, male per os H 302 Acut tox 4 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): reliable LC 50 =3.8 mg/l = 3800 mg/m3 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): H 311 Acut tox 3 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e7e558b-5a2e-484b-b0bd-88283df48c60/documents/5ef9f8c3-fbff-4dc8-a0dc-2319fd36262c_c46aaf95-394a-4769-87bd-bacf6f0c4f1a.html,,,,,, EPTC,759-94-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e7e558b-5a2e-484b-b0bd-88283df48c60/documents/5ef9f8c3-fbff-4dc8-a0dc-2319fd36262c_c46aaf95-394a-4769-87bd-bacf6f0c4f1a.html,,oral,LD50,760 mg/kg bw,adverse effect observed, EPTC,759-94-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e7e558b-5a2e-484b-b0bd-88283df48c60/documents/5ef9f8c3-fbff-4dc8-a0dc-2319fd36262c_c46aaf95-394a-4769-87bd-bacf6f0c4f1a.html,,dermal,LD50,500 mg/kg bw,adverse effect observed, EPTC,759-94-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e7e558b-5a2e-484b-b0bd-88283df48c60/documents/5ef9f8c3-fbff-4dc8-a0dc-2319fd36262c_c46aaf95-394a-4769-87bd-bacf6f0c4f1a.html,,inhalation,LC50,"3,800 mg/m3",no adverse effect observed, Erbium tetraoxide vanadium,13596-17-3," No acute toxicity studies with erbium tetraoxide vanadium are available, thus the acute toxicity will be addressed with existing data on the dissociation products. Erbium tetraoxide vanadium is not acutely toxic via the oral route. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7abc44df-393c-40b3-b866-398de42dcd64/documents/825b9c37-44c8-4fd2-9fbb-fd1943e00fac_df090633-5734-4d9b-94e2-75bdf94ec63f.html,,,,,, Erbium tetraoxide vanadium,13596-17-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7abc44df-393c-40b3-b866-398de42dcd64/documents/825b9c37-44c8-4fd2-9fbb-fd1943e00fac_df090633-5734-4d9b-94e2-75bdf94ec63f.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Oils, mentha spicata erospicata",1563063-07-9," Oral (OECD 423), rat: LD50 cut-off = 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bb8ba08-29a5-4861-95a2-9847c05659fe/documents/775c3e8d-ca4d-430a-bda2-f23e0512e0f1_2b67ea4a-dc38-46a0-974b-94eb48b26052.html,,,,,, "Oils, mentha spicata erospicata",1563063-07-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bb8ba08-29a5-4861-95a2-9847c05659fe/documents/775c3e8d-ca4d-430a-bda2-f23e0512e0f1_2b67ea4a-dc38-46a0-974b-94eb48b26052.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Essential Oil of Piper nigrum L. (Family: Piperaceae). Obtained by the steam distillation of dried unripe berries.,8006-82-4," Acute Oral Toxicity: The LD50 was estimated to be 5998.58 mg/kg bw,when male and female Wistar rats were orally exposed with Black Pepper Oil (8006-82-4) via gavage.Thus, comparing this value with the criteria of CLP regulation,Black Pepper Oil (8006-82-4) can be “Not classified” for Acute Oral Toxicity. Acute Dermal Toxicity: The LD50 value was estimated to be 2733.84 mg/kg bw,when male and female New Zealand White rabbits were exposed semiocclusively with Black Pepper Oil (8006-82-4)by dermal application for 24 hours.Thus, comparing this value with the criteria of CLP regulation, Black Pepper Oil (8006-82-4) can be “Not classified” for Acute Dermal Toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c2aeccb-ea01-42ac-b5df-2927e847962c/documents/2139c037-6260-41a0-95f8-5d7e58f4aca2_9f9ae5e6-3afb-4993-bcea-1c6940f4cb3a.html,,,,,, Essential Oil of Piper nigrum L. (Family: Piperaceae). Obtained by the steam distillation of dried unripe berries.,8006-82-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c2aeccb-ea01-42ac-b5df-2927e847962c/documents/2139c037-6260-41a0-95f8-5d7e58f4aca2_9f9ae5e6-3afb-4993-bcea-1c6940f4cb3a.html,,oral,LD50,"5,998.58 mg/kg bw",no adverse effect observed, Essential Oil of Piper nigrum L. (Family: Piperaceae). Obtained by the steam distillation of dried unripe berries.,8006-82-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c2aeccb-ea01-42ac-b5df-2927e847962c/documents/2139c037-6260-41a0-95f8-5d7e58f4aca2_9f9ae5e6-3afb-4993-bcea-1c6940f4cb3a.html,,dermal,LD50,"2,733.84 mg/kg bw",no adverse effect observed, Essential oil of Schinus Terebinthifolius (Anacardiaceae) obtained from red berries by supercritical carbon dioxide extraction,949495-68-5," Acute toxicity: oral: Standard quality (Item 2) has a LD50 > 5000 mg/kg bw (OECD 423 in rats; OECD 423, K, rel.1); ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ab55797-7a64-4481-b4f4-d254f24aa00a/documents/174321ef-c3d0-42c7-ba32-d0f7ec1d56e6_bb9cd327-4bb9-4c8e-9eb0-57ab28617bb0.html,,,,,, Essential oil of Schinus Terebinthifolius (Anacardiaceae) obtained from red berries by supercritical carbon dioxide extraction,949495-68-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ab55797-7a64-4481-b4f4-d254f24aa00a/documents/174321ef-c3d0-42c7-ba32-d0f7ec1d56e6_bb9cd327-4bb9-4c8e-9eb0-57ab28617bb0.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione",2105830-60-0, REACH_NOAEL = 1000 mg/kg bw/d | rat (male/female) | OECD 407 | #key study# ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f21d6161-974e-4954-aa73-09d60ccec5a5/documents/6ea560ba-6006-4b50-b4fc-1a58f4155ee8_93cc4636-b4bb-4863-83bb-20f7a02786de.html,,,,,, "Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione",2105830-60-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f21d6161-974e-4954-aa73-09d60ccec5a5/documents/6ea560ba-6006-4b50-b4fc-1a58f4155ee8_93cc4636-b4bb-4863-83bb-20f7a02786de.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione",2105830-60-0, REACH_LD50 > 2000 mg/kg | rat (female) | OECD 423 |  #key study# REACH_LD50 > 2000 mg/kg | rat (male/female) | similar to OECD 402 |  #key study# ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f21d6161-974e-4954-aa73-09d60ccec5a5/documents/e4f32d98-d174-4285-b014-0b0b19f9a062_93cc4636-b4bb-4863-83bb-20f7a02786de.html,,,,,, "Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione",2105830-60-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f21d6161-974e-4954-aa73-09d60ccec5a5/documents/e4f32d98-d174-4285-b014-0b0b19f9a062_93cc4636-b4bb-4863-83bb-20f7a02786de.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Esterification product of castor oil and tetrahydromethyl-1,3-isobenzofuranedione",2105830-60-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f21d6161-974e-4954-aa73-09d60ccec5a5/documents/e4f32d98-d174-4285-b014-0b0b19f9a062_93cc4636-b4bb-4863-83bb-20f7a02786de.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Esterification products of 2,2'-(oxydimethanediyl)bis[2-(hydroxymethyl)propane-1,3-diol] and heptanoic acid and pentanoic acid and 3,5,5-trimethylhexanoic acid",1149346-12-2,Acute Oral Toxicity: LD50 > 2000 mg/kg (male/female Wistar rats)     ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc0bcd77-9861-476c-9d87-ae5ee45af6a4/documents/615e79d2-5d79-4c3f-b6cc-2bacb95fd494_fb09e7c1-834f-4f40-acdb-cfc138b08c4a.html,,,,,, "Esterification products of 2,2'-(oxydimethanediyl)bis[2-(hydroxymethyl)propane-1,3-diol] and heptanoic acid and pentanoic acid and 3,5,5-trimethylhexanoic acid",1149346-12-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc0bcd77-9861-476c-9d87-ae5ee45af6a4/documents/615e79d2-5d79-4c3f-b6cc-2bacb95fd494_fb09e7c1-834f-4f40-acdb-cfc138b08c4a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Esterification products of 2,2-dimethylpropane-1,3-diol with n-heptanoic acid and n-octanoic acid and n-decanoic acid",70024-75-8, Acute oral LD50 > 2000 mg/kg bw; based on read-across from supporting substance (structural analogue or surrogate). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60896171-d930-4a77-aa95-2c56da3d09cb/documents/a8425537-5b2e-4801-b3f6-527e02f9fdb2_cf57adad-ae00-41af-8a0e-e7203306e8db.html,,,,,, "Esterification products of 2,2-dimethylpropane-1,3-diol with n-heptanoic acid and n-octanoic acid and n-decanoic acid",70024-75-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60896171-d930-4a77-aa95-2c56da3d09cb/documents/a8425537-5b2e-4801-b3f6-527e02f9fdb2_cf57adad-ae00-41af-8a0e-e7203306e8db.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Estr-4-ene-3,11,17-trione 3-(ethylene dithioketal) 17-(2,2-dimethylpropane-1,3-diyl ketal)",1174931-74-8,"Oral: LD50 = > 2000 and <= 5000 mg/kg bw, female rat; OECD 423, Lütkenhaus 2012 ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fe8f6bd-fd48-4dea-b7dc-209d104407b8/documents/IUC5-35084a2e-592e-4f51-9e74-7677041854a2_b35cd746-e7fc-4450-8912-9880a7c36e40.html,,,,,, "Estr-4-ene-3,11,17-trione 3-(ethylene dithioketal) 17-(2,2-dimethylpropane-1,3-diyl ketal)",1174931-74-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fe8f6bd-fd48-4dea-b7dc-209d104407b8/documents/IUC5-35084a2e-592e-4f51-9e74-7677041854a2_b35cd746-e7fc-4450-8912-9880a7c36e40.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Estr-4-ene-3,17-dione",734-32-7,"Regarding repeated dose toxicity potential, no studies were conducted with the target substance Norandrostenedione, however a variety of long-term toxicity studies in different species with the source substance Norethisterone are available. As known from an extensive data base animal experiments with progestins are only of limited predictive value for qualitative and even more for quanatitative extrapolation to humans because of a large diversity in factors responsible for endocrine regulation between experimental animals and man. Therefore the most sensitive endpoint that would be considered in risk assessment is the lowest oral daily dose with pharmacological effects in humans of norethisterone. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0472e302-3c94-483c-9500-76f24af4872c/documents/00d749e2-632d-41ea-815f-1b0573a1d470_d24cc783-d327-4cf4-bf61-d3e0e4d655a5.html,,,,,, "Estr-4-ene-3,17-dione",734-32-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0472e302-3c94-483c-9500-76f24af4872c/documents/00d749e2-632d-41ea-815f-1b0573a1d470_d24cc783-d327-4cf4-bf61-d3e0e4d655a5.html,Chronic toxicity – systemic effects,oral,NOAEL,1.25 mg/kg bw/day,,rat "Estr-4-ene-3,17-dione",734-32-7,"The acute toxicity (LD50) of norandrostendion in rats is > 1000 < 2000 mg/kg bw after oral administration (Kurth, 1996) or > 2000 mg/kg bw after dermal administration (Kurth, 1996). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0472e302-3c94-483c-9500-76f24af4872c/documents/IUC5-5997787b-229f-4153-b4d4-ac5108a9f0a3_d24cc783-d327-4cf4-bf61-d3e0e4d655a5.html,,,,,, "Estr-4-ene-3,17-dione",734-32-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0472e302-3c94-483c-9500-76f24af4872c/documents/IUC5-5997787b-229f-4153-b4d4-ac5108a9f0a3_d24cc783-d327-4cf4-bf61-d3e0e4d655a5.html,,oral,LD50,"> 1,000 mg/kg bw",adverse effect observed, "Estr-4-ene-3,17-dione",734-32-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0472e302-3c94-483c-9500-76f24af4872c/documents/IUC5-5997787b-229f-4153-b4d4-ac5108a9f0a3_d24cc783-d327-4cf4-bf61-d3e0e4d655a5.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "11a-Hydroxy-estr-4-ene-3,17-dione",6615-00-5,"Oral: LD50 > 300 and <= 2000 mg/kg bw, female rat; OECD 423, Lütkenhaus 2012 ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/486e364c-07e6-43e9-a1ed-008285933c99/documents/IUC5-6f609d96-5ef5-4f4b-a572-593a62288186_7ae47d1b-5c5d-4f23-97ca-008f0ee64ea7.html,,,,,, "11a-Hydroxy-estr-4-ene-3,17-dione",6615-00-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/486e364c-07e6-43e9-a1ed-008285933c99/documents/IUC5-6f609d96-5ef5-4f4b-a572-593a62288186_7ae47d1b-5c5d-4f23-97ca-008f0ee64ea7.html,,oral,discriminating dose,300 mg/kg bw,no adverse effect observed, "3,3-Dimethoxyestr-5(10)-en-17-one",19257-34-2,"LD50 oral (rat): > 2000 mg/kg bw [Kurth and Wick, 2000] ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/084fd259-b032-4a42-8ad7-8c7a17b55fa7/documents/IUC5-683b2bbb-99fd-42e6-a5ee-1a143e6466cf_36e77b2c-ebf8-400f-93c0-71869bf22b57.html,,,,,, "3,3-Dimethoxyestr-5(10)-en-17-one",19257-34-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/084fd259-b032-4a42-8ad7-8c7a17b55fa7/documents/IUC5-683b2bbb-99fd-42e6-a5ee-1a143e6466cf_36e77b2c-ebf8-400f-93c0-71869bf22b57.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 17 beta-Hydroxy-5(10)-estren-3-one,1089-78-7, LD50 oral > 2000 mg/kg bw. [Kurth 2007] LD50dermal > 2000 mg/kg bw. [Kurth 2007] ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d71d6f0c-a12c-416d-8315-0494dfbbf906/documents/90789981-1538-469f-891a-3a19345009e8_037e2d22-f37d-4da8-b5be-00812953da8f.html,,,,,, 17 beta-Hydroxy-5(10)-estren-3-one,1089-78-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d71d6f0c-a12c-416d-8315-0494dfbbf906/documents/90789981-1538-469f-891a-3a19345009e8_037e2d22-f37d-4da8-b5be-00812953da8f.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 17 beta-Hydroxy-5(10)-estren-3-one,1089-78-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d71d6f0c-a12c-416d-8315-0494dfbbf906/documents/90789981-1538-469f-891a-3a19345009e8_037e2d22-f37d-4da8-b5be-00812953da8f.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "17B-hydroxyestra-4,6-diene-3-one",14531-84-1,LD50 cut-off value was considered to be 1000 mg/kg body weight ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2489a590-dc14-4931-8e03-d9cd6cf750a3/documents/IUC5-1995f025-b44f-4b2d-9bba-390c0f1bd720_19e04440-9ad0-4490-aacc-35054dcc822d.html,,,,,, "17 beta-Hydroxy-4,9-estradien-3-one",6218-29-7,"Oral (Rat, OECD TG 423): LD50 > 2000 mg/kg[Bayer HealthCare, Bayer Schering Pharma, Report No. A34031 -draft-, 2008-03-05]Dermal (Rat, GLP, OECD TG 402): LD50 > 2000 mg/kg[Schering AG, Report No. A34485, 2008-08-07] ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f78c21f-4c53-4e07-84af-2025610cd50c/documents/IUC5-ebce3927-385c-41fb-9d35-f59dbd8d90aa_b4461800-203c-43da-aa68-7a53e7f3011d.html,,,,,, 2(2-Amino-ethoxy)-2'chloro-diethylsulfone Hydrochloride,98231-71-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Upon an acute oral administration and a 14 day post-treatment observation period, the following LD50 (with 95% confidence limits calculated, where possible) was determined for FAT 92024/B LD50 in male rats: > 2000, < 5000 mg/kg bw. LD50 in female rats: > 2000, < 5000 mg/kg bw. LD50 in rats of both sexes: > 2000, < 5000 mg/kg bw. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6cf5996-a9c2-4cc4-8ce1-d350ee14356b/documents/IUC5-eb55bd76-0277-4f51-a70a-56cbcc1f14da_0fe27065-fbe3-4f62-bd61-922221788e36.html,,,,,, 2(2-Amino-ethoxy)-2'chloro-diethylsulfone Hydrochloride,98231-71-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6cf5996-a9c2-4cc4-8ce1-d350ee14356b/documents/IUC5-eb55bd76-0277-4f51-a70a-56cbcc1f14da_0fe27065-fbe3-4f62-bd61-922221788e36.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Ethanamine, N-ethyl-, reaction products with polyethylene-polypropylene glycol ether with trimethylolpropane (3:1) acrylate (>1 <6.5 mol EO and >1 < 6.5 mol PO)",173046-61-2, NOAEL local effects: 300 mg/kg bw/d (hyperplasia and ulcers in the high dose group) NOAEL systemic effects: 1000 mg/kg bw/d ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd499068-f270-4d9b-aa72-5af0f07c3fcb/documents/460fdabc-e829-49c8-9f00-33b21cfe600e_b00e1c5c-b2df-4584-8862-a1329dbe22a0.html,,,,,, "Ethanamine, N-ethyl-, reaction products with polyethylene-polypropylene glycol ether with trimethylolpropane (3:1) acrylate (>1 <6.5 mol EO and >1 < 6.5 mol PO)",173046-61-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd499068-f270-4d9b-aa72-5af0f07c3fcb/documents/460fdabc-e829-49c8-9f00-33b21cfe600e_b00e1c5c-b2df-4584-8862-a1329dbe22a0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Ethanamine, N-ethyl-, reaction products with polyethylene-polypropylene glycol ether with trimethylolpropane (3:1) acrylate (>1 <6.5 mol EO and >1 < 6.5 mol PO)",173046-61-2," LD50 (oral): > 2000 mg/kg bw; LD50 (dermal): > 2000 mg/kg bw (read-across from structural analogues CAS 118800-30-9, CAS 195008-76-5 and CAS 173011-06-8) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd499068-f270-4d9b-aa72-5af0f07c3fcb/documents/32473d02-e5b3-4d9d-a20a-f237fd565d2f_b00e1c5c-b2df-4584-8862-a1329dbe22a0.html,,,,,, "Ethanamine, N-ethyl-, reaction products with polyethylene-polypropylene glycol ether with trimethylolpropane (3:1) acrylate (>1 <6.5 mol EO and >1 < 6.5 mol PO)",173046-61-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd499068-f270-4d9b-aa72-5af0f07c3fcb/documents/32473d02-e5b3-4d9d-a20a-f237fd565d2f_b00e1c5c-b2df-4584-8862-a1329dbe22a0.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Ethanamine, N-ethyl-, reaction products with polyethylene-polypropylene glycol ether with trimethylolpropane (3:1) acrylate (>1 <6.5 mol EO and >1 < 6.5 mol PO)",173046-61-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd499068-f270-4d9b-aa72-5af0f07c3fcb/documents/32473d02-e5b3-4d9d-a20a-f237fd565d2f_b00e1c5c-b2df-4584-8862-a1329dbe22a0.html,,dermal,discriminating dose,"2,000 mg/kg bw",, "Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides",1079184-43-2," One 28 day repeated dose study comparable to OECD Guideline 407 and one sub-chronic toxicity study comparable to OECD Guideline 408 are available for the oral route of administration. The no effect level (NOEL) was determined to be 500 mg/kg/day. In addition, no adverse effects were observed in an EOGRTS with basic test design up to the limit dose of 1000 mg/kg bw/d. This study included a thorough examination of general toxicity. Therefore, the NOAEL obtained in the EOGRTS is considered as the key value for hazard assessment. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54b95523-5de5-4ac7-8c77-d29a10317acb/documents/IUC5-a5ab6afe-a246-4fb1-9377-2a9f151514bb_0efa6035-9803-48b4-b9ef-05a73d551b5f.html,,,,,, "Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides",1079184-43-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54b95523-5de5-4ac7-8c77-d29a10317acb/documents/IUC5-a5ab6afe-a246-4fb1-9377-2a9f151514bb_0efa6035-9803-48b4-b9ef-05a73d551b5f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides",1079184-43-2,"Human data on the acute toxicity of MDEA-Esterquat C16-18 and C18 unsatd. are not available.In rats, mice and rabbits the substance is practically non-toxic with an oral LD50 of > 10 000 mg/kg bw and a dermal LD50 of > 2000 mg/kg bw. The NOAEL for acute oral toxicity is 10 000 mg/kg bw in the rat and 3160 mg/kg bw in mice. The NOAEL for acute dermal toxicity in the rabbit is 2000 mg/kg bw.In the Irwin dose-range study in mice, at the highest dose of 10 000 mg/kg bw one animal showed indications for CNS depression and died after 1 day. No effects were recorded at any time during the study at lower doses of 316, 1000 and 3160 mg/kg bw.Generation of inhalable particles such as dust or aerosols is not relevant under the specific operational conditions. Vaporisation needs not to be considered due to the very low vapour pressure of < 10-7 kPa. Therefore, inhalation is not a relevant route of exposure and testing by the inhalation route is not appropriate. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54b95523-5de5-4ac7-8c77-d29a10317acb/documents/IUC5-2815c5a2-1858-41b2-89eb-cac47240d585_0efa6035-9803-48b4-b9ef-05a73d551b5f.html,,,,,, "Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides",1079184-43-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54b95523-5de5-4ac7-8c77-d29a10317acb/documents/IUC5-2815c5a2-1858-41b2-89eb-cac47240d585_0efa6035-9803-48b4-b9ef-05a73d551b5f.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Ethanaminium, 2-hydroxy-N-(2-hydroxyethyl)-N,N-dimethyl-, esters with C16-18 and C18-unsatd. fatty acids, chlorides",1079184-43-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54b95523-5de5-4ac7-8c77-d29a10317acb/documents/IUC5-2815c5a2-1858-41b2-89eb-cac47240d585_0efa6035-9803-48b4-b9ef-05a73d551b5f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, molybdatetungstatephosphate",1325-87-7," In a combined repeated dose oral gavage toxicity study with the reproduction/developmental toxicity screening with Pigment Blue 1 the No-Observed-Effect Level (NOEL) for general toxicity was considered to be 100 mg/kg bw/day, taking into account that there was mortality, lower body weighs and histopathological findings in kidneys (tubular basophilia) were recorded at 300 and 1000 mg/kg/day with respect to Control. Based on these findings and on the fact that litter loss does not seem to be dose-related, the No Observed Adverse Effect Level (NOAEL) could be established at 100 mg/kg/day, as the increased incidence of adrenal cortical hypertrophy with respect to controls is considered mainly a response to stress. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/510fd491-6d80-4207-a314-1a61a3471ad6/documents/bf8b652b-f630-4f8e-8332-edbcaac59913_13e8957b-ef2e-478e-896f-89cf44b91f55.html,,,,,, "Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, molybdatetungstatephosphate",1325-87-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/510fd491-6d80-4207-a314-1a61a3471ad6/documents/bf8b652b-f630-4f8e-8332-edbcaac59913_13e8957b-ef2e-478e-896f-89cf44b91f55.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,300 mg/kg bw/day,,rat "Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, molybdatetungstatephosphate",1325-87-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Guideline study conducted in 2017 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/510fd491-6d80-4207-a314-1a61a3471ad6/documents/feb7b661-a092-44d9-8d29-2fcd0e1e2f5d_13e8957b-ef2e-478e-896f-89cf44b91f55.html,,,,,, "Ethanaminium, N-[4-[[4-(diethylamino)phenyl][4-(ethylamino)-1-naphthalenyl]methylene]-2,5-cyclohexadien-1-ylidene]-N-ethyl-, molybdatetungstatephosphate",1325-87-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/510fd491-6d80-4207-a314-1a61a3471ad6/documents/feb7b661-a092-44d9-8d29-2fcd0e1e2f5d_13e8957b-ef2e-478e-896f-89cf44b91f55.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Ethane- 1,2-diol, propoxylated",31923-84-9," Subacute (28-day) oral repeated dose toxicity (OECD 407): NOAEL (rat, f) = 1000 mg/kg bw/day, NOAEL (rat, m) = 300 mg/kg bw/day (based on effects on the spleen) Subchronic (90-day) oral repeated dose toxicity (OECD 408): NOAEL (rat, m/f) = 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f11ff8aa-f59f-46b4-b8ad-83528bf238da/documents/09a8d9b1-ff64-4823-b359-69b1363f9800_677880bd-e446-4e9e-ad5c-633f8b0ba65f.html,,,,,, "Ethane- 1,2-diol, propoxylated",31923-84-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f11ff8aa-f59f-46b4-b8ad-83528bf238da/documents/09a8d9b1-ff64-4823-b359-69b1363f9800_677880bd-e446-4e9e-ad5c-633f8b0ba65f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Ethane- 1,2-diol, propoxylated",31923-84-9," Acute oral toxicity (OECD 423): LD50 (rat, f) > 2000 mg/kg bw Acute dermal toxicity (OECD 402): LD50 (rat, m/f) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f11ff8aa-f59f-46b4-b8ad-83528bf238da/documents/afce3721-1fdc-4f51-b176-211b2cfbdd22_677880bd-e446-4e9e-ad5c-633f8b0ba65f.html,,,,,, "1,1,2-trichloro-1,2-difluoroethane",354-15-4," In vivo tests are reported. The results show that HCFC 122a is a low-toxic compound following oral and inhalation expsoure. No toxicity was observed following dermal exposure. According to Regulation (EU) 1272/2008, HCFC 122a does not fulfill the classification criteria for the Acute Toxicity hazard classes. Following exposure by inhalation or oral routes, clinical signs included symptoms of damage to the nervous system: short period of agitation followed by lethargy, drowsiness, muscle twitching and narcosis. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12e821f5-5da4-4e19-86e3-8fc07db92c77/documents/IUC5-af22a99e-1fa5-4be8-8fe2-0e19847bd64a_1ae27c79-9d88-4256-8542-32fbbc092e8e.html,,,,,, "1,1,2-trichloro-1,2-difluoroethane",354-15-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12e821f5-5da4-4e19-86e3-8fc07db92c77/documents/IUC5-af22a99e-1fa5-4be8-8fe2-0e19847bd64a_1ae27c79-9d88-4256-8542-32fbbc092e8e.html,,oral,LD50,"7,800 mg/kg bw",adverse effect observed, "1,1,2-trichloro-1,2-difluoroethane",354-15-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12e821f5-5da4-4e19-86e3-8fc07db92c77/documents/IUC5-af22a99e-1fa5-4be8-8fe2-0e19847bd64a_1ae27c79-9d88-4256-8542-32fbbc092e8e.html,,inhalation,LC50,"72,000 mg/m3",adverse effect observed, "1,2-Dichloro-1-[difluoro(trifluoromethoxy)methoxy]-1,2,2-trifluoroethane",874288-98-9," One acute toxicity study by oral route is available. The study was conducted according to OECD guideline 423 and in compliance with Good Laboratory Practice (GLP) criteria. The LD50 (rat) was higher than 2000 mg/kg bw, moreover no significant toxic effect following oral administration of a single dose of 2000 mg/kg bw was observed. No acute toxicity study by dermal route or by inhalation are available for MOVE 3 Adduct. An estimation of the potential for acute dermal toxicity is done on the basis of the data available from acute oral toxicity and on considerations of dermal absorption potential. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5f4cef2-ad47-4821-9d2c-3ddaf02358ac/documents/223bc2cd-5d2b-42d5-85d8-d8b60274625e_2c1f0781-1233-410b-bf9b-c5cf4019b3a3.html,,,,,, "1,2-Dichloro-1-[difluoro(trifluoromethoxy)methoxy]-1,2,2-trifluoroethane",874288-98-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5f4cef2-ad47-4821-9d2c-3ddaf02358ac/documents/223bc2cd-5d2b-42d5-85d8-d8b60274625e_2c1f0781-1233-410b-bf9b-c5cf4019b3a3.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-Chloro-1,1-difluoroethane",338-65-8,"Oral (Rat, according to OECD TG 423): LD50 >2000 mg/kg   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch score 1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78ac3538-9e52-4cdf-89b5-745f7a16d4a9/documents/a449aa07-1cad-4c82-955e-ca2ce38d4c3b_74cd603d-98b2-4f85-8aa3-a75ab2760251.html,,,,,, "2-Chloro-1,1-difluoroethane",338-65-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78ac3538-9e52-4cdf-89b5-745f7a16d4a9/documents/a449aa07-1cad-4c82-955e-ca2ce38d4c3b_74cd603d-98b2-4f85-8aa3-a75ab2760251.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "ethane-1,2-bis(aminium) methylphosphonate",99580-93-5,"28d-NOAEL, oral = 50 mg/kg/bw/day28d- and 90d, dermal: waived28d- and 90d, inhalation: waived ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e68c084-f2da-4711-9c43-a9eb6a463182/documents/IUC5-fac8a901-7cfb-4c7e-8654-d9f40ff3bf9d_324b8997-26ea-48dc-9d9e-e0a514f8ebe7.html,,,,,, "ethane-1,2-bis(aminium) methylphosphonate",99580-93-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e68c084-f2da-4711-9c43-a9eb6a463182/documents/IUC5-fac8a901-7cfb-4c7e-8654-d9f40ff3bf9d_324b8997-26ea-48dc-9d9e-e0a514f8ebe7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "ethane-1,2-bis(aminium) methylphosphonate",99580-93-5,"LD50, oral > 2000 mg/kg bwLD50, dermal > 2000 mg/kg bwacute Tox. inhalation: waived ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e68c084-f2da-4711-9c43-a9eb6a463182/documents/IUC5-187cdb12-ca4b-4fa3-a305-b85ca74fa4c1_324b8997-26ea-48dc-9d9e-e0a514f8ebe7.html,,,,,, "ethane-1,2-bis(aminium) methylphosphonate",99580-93-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e68c084-f2da-4711-9c43-a9eb6a463182/documents/IUC5-187cdb12-ca4b-4fa3-a305-b85ca74fa4c1_324b8997-26ea-48dc-9d9e-e0a514f8ebe7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "ethane-1,2-bis(aminium) methylphosphonate",99580-93-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e68c084-f2da-4711-9c43-a9eb6a463182/documents/IUC5-187cdb12-ca4b-4fa3-a305-b85ca74fa4c1_324b8997-26ea-48dc-9d9e-e0a514f8ebe7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Ethane-1,2-diyl palmitate",624-03-3,"Oral (subacute, OECD 422, GLP, rat, m/f): NOAEL (systemic toxicity) ≥ 15000 ppm (corresponding to an actual test substance intake of 1079 and 1175 mg/kg bw/day for males and females, respectively) Conclusion based on data obtained with ethane-1,2-diyl palmitate (EC 210-826-5, CAS 624-03-3). Oral (subchronic): NOAEL (systemic toxicity) ≥ 1000 mg/kg bw/day Read-across based on grouping of substances (analogue approach) considering all available data on subchronic repeated dose toxicity with the source substances decanoic acid, mixed diesters with octanoic acid and propylene glycol (EC 271-516-3, CAS 68583-51-7), fatty acids, C18 and C18 unsatd. epoxidized, ester with ethylene glycol (CAS 151661-88-0), and stearic acid, monoester with propane-1,2-diol (EC 215-354-3, CAS 1323-39-3; all not part of the ethylene glycol esters category) in a weight of evidence approach. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17c9458a-7901-45d8-a9a2-b7bb6cf7dc05/documents/77d62904-2929-479c-9957-30f39eefb1f8_6036fccc-727a-4a70-910c-ae9dc014b2da.html,,,,,, "Ethane-1,2-diyl palmitate",624-03-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17c9458a-7901-45d8-a9a2-b7bb6cf7dc05/documents/77d62904-2929-479c-9957-30f39eefb1f8_6036fccc-727a-4a70-910c-ae9dc014b2da.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,">= 1,079 mg/kg bw/day",,rat "Ethane-1,2-diyl palmitate",624-03-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17c9458a-7901-45d8-a9a2-b7bb6cf7dc05/documents/77d62904-2929-479c-9957-30f39eefb1f8_6036fccc-727a-4a70-910c-ae9dc014b2da.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat "Ethane-1,2-diyl palmitate",624-03-3,"Oral LD50 > 2000 mg/kg bw Read-across based on grouping of substances (category approach) considering all available data on acute oral toxicity in the ethylene glycol esters category in a weight of evidence approach.   Inhalation No information is required according to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, as data on acute oral toxicity are provided and the oral and dermal route are considered more relevant.   Dermal No information is required according to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5.2, Column 2, as the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure performed with ethylene glycol esters category substances. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17c9458a-7901-45d8-a9a2-b7bb6cf7dc05/documents/d386e8b2-6618-4689-981e-fe22f09e6507_6036fccc-727a-4a70-910c-ae9dc014b2da.html,,,,,, "Ethane-1,2-diyl palmitate",624-03-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17c9458a-7901-45d8-a9a2-b7bb6cf7dc05/documents/d386e8b2-6618-4689-981e-fe22f09e6507_6036fccc-727a-4a70-910c-ae9dc014b2da.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Ethane-1,2-diylbis[dichloromethylsilane]",3353-69-3," There are no repeated dose oral, inhalation or dermal studies available for 1,2 -bis[dichloro(methyl)silyl]ethane. Data waivers are in place for oral and dermal repeated dose toxicity endpoints (see attachment to data waiver for repeated dose toxicity: oral).   Since the local corrosive effects of chlorosilanes would be significant, valid oral or inhalation studies according to the relevant guidelines are technically not feasible. It is also unlikely that any systemic effects would be observed at doses made sufficiently low to prevent the known corrosive effects and/or distress in the test species. Indeed, ECHA’s Executive Director made the following statement in his decision (No. ED/49/2015) for trichlorosilane “ECHA notes that the Contested Decision should not have provided the option of carrying out the PNDT study on the registered substance, which is corrosive and consequently can only be tested at very low concentrations. In a PNDT study, which normally requires high systematic availability of the tested substance, the very low concentrations would almost certainly lead to a negative result”.   To support this conclusion a 28-day inhalation study with another chlorosilane, dichloro(dimethyl)silane (CAS 75-78-5, WIL, 2014) is used to demonstrate that local effects are dominated by generation of the hydrolysis product, HCl, and that there are no adverse systemic effects.   In a well conducted 90-day gas inhalation study (Toxigenics, 1984) the systemic NOAEC for hydrogen chloride was 20 ppm based on decreased body weight following exposure to 50 ppm (6 hours/day, 5 days/week) in rats and mice. The main adverse findings related to irritant/corrosive effects on the nasal turbinates in mice, which was observed with a LOAEC of 10 ppm. A good quality 90-day repeated inhalation study for hydrogen chloride has been used to assess the local effects of 1,2 -bis[dichloro(methyl)silyl]ethane . In a 90-day repeated inhalation study with HCl, no serious adverse systemic effects were observed in rats and mice exposed up to 50 ppm (approximately 70 mg/m3) for 6 hours per day, 5 days per week (Toxigenics, 1983). The only significant adverse finding relating to systemic toxicity was decreased body weight at the highest dose level. Local effects on the nasal turbinates of mice were observed at all dose levels tested (10, 20 and 50 ppm). Testing with HCl at higher test concentrations is neither ethically nor technically feasible since severe corrosive effects would lead to discomfort and distress in the test animals. The author of this CSR considers that the apparent systemic effects at 50 ppm in the study were most likely secondary to local corrosive effects at this dose level. Following uptake of HCl, hydrogen and chloride ions from will enter the body’s natural homeostatic processes and significant systemic effects are unlikely. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e369e741-1537-48ab-8eba-cd5a8b9c39d2/documents/4b1467a4-c927-49d9-85cd-c3cc42fa8c85_c915fc85-0e89-4b20-878b-aad64d1493d1.html,,,,,, "Ethane-1,2-diylbis[dichloromethylsilane]",3353-69-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e369e741-1537-48ab-8eba-cd5a8b9c39d2/documents/4b1467a4-c927-49d9-85cd-c3cc42fa8c85_c915fc85-0e89-4b20-878b-aad64d1493d1.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,132 mg/m3,,rat "Ethane-1,2-diylbis[dichloromethylsilane]",3353-69-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e369e741-1537-48ab-8eba-cd5a8b9c39d2/documents/4b1467a4-c927-49d9-85cd-c3cc42fa8c85_c915fc85-0e89-4b20-878b-aad64d1493d1.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 mg/m3,adverse effect observed,rat "Ethane-1,2-diylbis[dichloromethylsilane]",3353-69-3," No acute oral and inhalation toxicity studies were available for the registered substance. In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the oral route (required in Section 8.5.1) does not need to be conducted as the substance is classified as corrosive. In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5.2) does not need to be conducted as the substance is classified as corrosive. In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the dermal route (required in Section 8.5.3) does not need to be conducted as the substance is classified as corrosive. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e369e741-1537-48ab-8eba-cd5a8b9c39d2/documents/8602f34b-aef3-45d1-8345-50b175e17e9b_c915fc85-0e89-4b20-878b-aad64d1493d1.html,,,,,, "Ethanediamide, N1-(5-chloro-2-pyridinyl)-N2-[(1S,2R,4S)-4-[(dimethylamino)carbonyl]-2-[[(4,5,6,7-tetrahydro-5-methylthiazolo[5,4-c]pyridin-2-yl)carbonyl]amino]cyclohexyl]",480449-70-5,NOAEL Oral Rat = 54 mg/kg/day - Duration: 6 months NOAEL Oral monkey = 5 mg/kg/day - Duration: 52 weeks Data on the final API. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22e1f9e5-bb7e-47be-925a-76ff23f4042f/documents/e8e44d35-a537-4ab1-a661-9b2a87bd3ee2_1247f40d-10aa-4cde-bda7-b7051e3ef8cf.html,,,,,, disodium 2-[N-hydroxy-N-(2-sulfonatoethyl)amino]ethane-1-sulfonate,133986-51-3," The oral LD50 value is in excess of 2000 mg/kg bw; the 4-h LC50 value of structurally related substances is in excess of 5 g/m3. No acute dermal toxicity studies are available but based on read across (see also section 13), acute dermal toxicity following exposure is not expected. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64784aa4-673e-47ea-8747-dd385dc13503/documents/34f90e59-e3f3-45e6-9c3f-e694db490919_078f5c70-630e-4d44-9fb1-31d0de7aad8b.html,,,,,, Ethanethiol,75-08-1,"Kidney changes indicative of alpha2u-globulin nephropathy were observed in male rats in the OECD test guideline 422 oral gavage study on 2-methylpropane-2-thiol (MHLW, 2006) and in the 90-day inhalation study on butane-2-thiol (Kim et al., 2009). Alpha2u-globulin nephropathy is a male rat-specific effect that is not relevant to humans. Hemosiderin accumulation in the spleen following oral and inhalation exposure to 2-methylpropane-2-thiol and butane-2-thiol, respectively, appears to be the result of increased destruction of RBC in the spleen. This is supported by the hematological changes of decreased red blood cells, hemoglobin, and hematocrit. However, this finding was slight in nature and is not considered adverse. Centrilobular hepatocellular hypertrophy was also observed in both male and female rats the oral study on 2-methylpropane-2-thiol. The nasal cavity effects observed in rats exposed by inhalation to butane-2-thiol are likely due to a localized chronic irritation. There were also increased alveolar macrophages (described as trace severity) in the respiratory tract of rats exposed to butane-1-thiol. However, in the absence of any other histopathological changes in that study, it is questionable whether this finding is indicative of a localized irritation response. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5aeff1ee-b712-4ee6-b6d9-6ae5a500dccf/documents/IUC5-577670de-01fb-4f6c-9ae6-f0a4bdac12e3_ebdb0bd7-23d9-4151-80bb-64151d25cf02.html,,,,,, Ethanethiol,75-08-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5aeff1ee-b712-4ee6-b6d9-6ae5a500dccf/documents/IUC5-577670de-01fb-4f6c-9ae6-f0a4bdac12e3_ebdb0bd7-23d9-4151-80bb-64151d25cf02.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Ethanethiol,75-08-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5aeff1ee-b712-4ee6-b6d9-6ae5a500dccf/documents/IUC5-577670de-01fb-4f6c-9ae6-f0a4bdac12e3_ebdb0bd7-23d9-4151-80bb-64151d25cf02.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,550 mg/m3,,rat Ethanethiol,75-08-1,"Key acute oral, dermal, and inhalation toxicity studies were identified. • The oral LD50 was 682 mg/kg bw in male rats (Fairchild, 1958)• The acute dermal LD0 was >2000 mg/kg bw in rabbits (Fairchild, 1958)• The acute inhalation LC50 was 11.23 mg/L (11230 mg/m3) in rats (Latven, 1977) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5aeff1ee-b712-4ee6-b6d9-6ae5a500dccf/documents/IUC5-4b2cb700-05b2-4122-823d-dcd50f746534_ebdb0bd7-23d9-4151-80bb-64151d25cf02.html,,,,,, Ethanethiol,75-08-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5aeff1ee-b712-4ee6-b6d9-6ae5a500dccf/documents/IUC5-4b2cb700-05b2-4122-823d-dcd50f746534_ebdb0bd7-23d9-4151-80bb-64151d25cf02.html,,oral,LD50,682 mg/kg bw,adverse effect observed, Ethanethiol,75-08-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5aeff1ee-b712-4ee6-b6d9-6ae5a500dccf/documents/IUC5-4b2cb700-05b2-4122-823d-dcd50f746534_ebdb0bd7-23d9-4151-80bb-64151d25cf02.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethanethiol,75-08-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5aeff1ee-b712-4ee6-b6d9-6ae5a500dccf/documents/IUC5-4b2cb700-05b2-4122-823d-dcd50f746534_ebdb0bd7-23d9-4151-80bb-64151d25cf02.html,,inhalation,LC50,"11,230 mg/m3",adverse effect observed, "Ethanol, 2-(ethenylthio)-",3090-56-0, The acute oral LD50 for the test substance was determined to be ca. 3.0 mL/kg (ca. 3200 mg/kg) in rats. The acute inhalation LD50 for the test substance as saturated atmosphere was determined to be > 1.14 mg/L in rats. The acute LD50 after intraperitoneal application of the test substance was determined to be ca. 0.57 mL/kg (ca. 608 mg/kg) in mice. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/455b27ee-0282-4b97-b5ab-4239a00eb455/documents/0472910a-e800-4237-95d2-f06bf14bb86e_45dba327-39df-42d1-8120-1163c0101813.html,,,,,, "Ethanol, 2-(ethenylthio)-",3090-56-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/455b27ee-0282-4b97-b5ab-4239a00eb455/documents/0472910a-e800-4237-95d2-f06bf14bb86e_45dba327-39df-42d1-8120-1163c0101813.html,,oral,LD50,"3,200 mg/kg bw",no adverse effect observed, "Ethanol, 2-(ethenylthio)-",3090-56-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/455b27ee-0282-4b97-b5ab-4239a00eb455/documents/0472910a-e800-4237-95d2-f06bf14bb86e_45dba327-39df-42d1-8120-1163c0101813.html,,inhalation,LC50,"1,140 mg/m3",no adverse effect observed, "Ethanol, 2,2'-[1,2-ethanediylbis(oxy)]bis-, reaction products with 3-(triethoxysilyl)-1-propanamine",152261-44-4, REACH_LD50 > 2000 mg/kg bw | rat (male/female) | OECD 423 | #key study# ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90b66a57-368e-4455-a97f-d87ff8ed7832/documents/5c453325-a012-4f3a-b279-b77ebd00c71a_89a7bd8d-5e07-4e01-848f-17b90a9da67d.html,,,,,, "2,2'-(C16-18 (evennumbered, C18 unsaturated) alkyl imino) diethanol",1218787-32-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The lowest 90-day NOAEL comes from the read-across from Oleyl-PFAEO and represents the most recent and complete study. The value is lower than the NOAEL from the old 90-day study on Tallow-PFAEO itself. However, when information is combined with very recent guideline studies on the substance itself, as with read-across to long-term studies with similar PFAEO substance, all show a consistent pattern of local effects driving the NOAEL. This value of 30 mg/kg bw is therefore a conservative starting point for NOAEL for systemic toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df16f4c5-0448-4c3f-891a-4cebcf54a055/documents/IUC5-392680d0-13ac-4ddd-b9ab-b2943dfe14bd_d370f20a-54c2-4bce-b061-347b25dd06d4.html,,,,,, "2,2'-(C16-18 (evennumbered, C18 unsaturated) alkyl imino) diethanol",1218787-32-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df16f4c5-0448-4c3f-891a-4cebcf54a055/documents/IUC5-392680d0-13ac-4ddd-b9ab-b2943dfe14bd_d370f20a-54c2-4bce-b061-347b25dd06d4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "2,2'-(C16-18 (evennumbered, C18 unsaturated) alkyl imino) diethanol",1218787-32-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): There are three acute oral toxicity studies, of which two are validity 2, the other being only supportive data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df16f4c5-0448-4c3f-891a-4cebcf54a055/documents/IUC5-fc4ec787-1461-402d-ad7d-e663e565c430_d370f20a-54c2-4bce-b061-347b25dd06d4.html,,,,,, "2,2'-(C16-18 (evennumbered, C18 unsaturated) alkyl imino) diethanol",1218787-32-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df16f4c5-0448-4c3f-891a-4cebcf54a055/documents/IUC5-fc4ec787-1461-402d-ad7d-e663e565c430_d370f20a-54c2-4bce-b061-347b25dd06d4.html,,oral,LD50,"1,350 mg/kg bw",adverse effect observed, "Ethanol, 2,2'-iminobis-, N-C12-18-alkyl derivs.",71786-60-2,"Ethanol, 2, 2’-iminobis-, N-coco alkyl derives CAS No 61791-31-9has been registered for REACH as 2, 2’-(C12-18 evennumbered alkyl imino) diethanol CAS No 71786-60-2.   A 14 day dose ranging gavage study was carried tout to anable the dose levels to be selected for a levels for an OECD guideline 422 (Gavage) Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (adopted 22 March 1996).   From an OECD 422 study (42 day) on the substance a NOAEL of 30 mg/kg bw/day for repeat dose systemic toxicity was derived.   Additional testing was required as 2, 2’-(C12-18 evennumbered alkyl imino) diethanol is a high tonnage Annex X substance, ECHA required an OECD408, 90-day (13 week) oral study in rats. A NOAEL for repeat dose toxicity was also derived from the study.   An OECD 443 on the substance was also conducted. This resulted in cataract formation of one or both eyes in both sexes at 30 and 100 mg/kg bw/day. Thickening of the non-glandular stomach was observed in males and females administered 100 mg/kg/day, and in males administered 30 mg/kg/day.  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Very good ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cea174e6-2d96-4eb6-8765-4ec625959ad0/documents/IUC5-2a300108-b8f3-4335-b7ef-05ede55db15f_f70e41f1-fd38-4505-b42e-96ee102a90e1.html,,,,,, "Ethanol, 2,2'-iminobis-, N-C12-18-alkyl derivs.",71786-60-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cea174e6-2d96-4eb6-8765-4ec625959ad0/documents/IUC5-2a300108-b8f3-4335-b7ef-05ede55db15f_f70e41f1-fd38-4505-b42e-96ee102a90e1.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,10 mg/kg bw/day,,rat "Ethanol, 2,2'-iminobis-, N-C12-18-alkyl derivs.",71786-60-2,"Ethanol, 2,2’-iminobis-, N-coco alkyl derives CAS No 61791-31-9 will be registered for REACH as 2, 2’-(C12-18 evennumbered alkyl imino) diethanol  CAS No 71786-60-2.  The only available information is on acute oral toxicity, testing by the inhalation and dermal routes is waived. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cea174e6-2d96-4eb6-8765-4ec625959ad0/documents/IUC5-f567ef1f-f56a-4564-b3e2-bb7fdb847753_f70e41f1-fd38-4505-b42e-96ee102a90e1.html,,,,,, "Ethanol, 2,2'-iminobis-, N-C12-18-alkyl derivs.",71786-60-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cea174e6-2d96-4eb6-8765-4ec625959ad0/documents/IUC5-f567ef1f-f56a-4564-b3e2-bb7fdb847753_f70e41f1-fd38-4505-b42e-96ee102a90e1.html,,oral,LD50,"1,500 mg/kg bw",adverse effect observed, "2,2'-oxybis-ethanol diformate",120570-77-6," NOAEL (90d, OECD 408) rat, oral = 300 mg/kg bw /day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f7ba396-7be4-46d9-a718-ae00d152c819/documents/IUC5-07c75f97-0ed6-4b8a-b640-a7f842baab42_aef98170-49d0-462c-801e-8788f8e06e81.html,,,,,, "2,2'-oxybis-ethanol diformate",120570-77-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f7ba396-7be4-46d9-a718-ae00d152c819/documents/IUC5-07c75f97-0ed6-4b8a-b640-a7f842baab42_aef98170-49d0-462c-801e-8788f8e06e81.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2,2'-oxybis-ethanol diformate",120570-77-6," Based on read-across from Ethylene diformate (CAS 629-15-2): Oral: LD50 (guinea pig, m/f) = 390 mg/kg bw (lowest dose descriptor available selected for CSR calculations) Oral: LD50 (rat, m/f) = 1500 mg/kg bw (selected for read across justification) Inhalation: LC50 (rat, m/f) > 5.05 mg/L ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f7ba396-7be4-46d9-a718-ae00d152c819/documents/IUC5-930e69f6-4590-4e54-8d3f-b7ef2ff50f04_aef98170-49d0-462c-801e-8788f8e06e81.html,,,,,, "2,2'-oxybis-ethanol diformate",120570-77-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f7ba396-7be4-46d9-a718-ae00d152c819/documents/IUC5-930e69f6-4590-4e54-8d3f-b7ef2ff50f04_aef98170-49d0-462c-801e-8788f8e06e81.html,,oral,LD50,390 mg/kg bw,adverse effect observed, "Ethanol, 2,2'-oxybis-, reaction products with 3-(triethoxysilyl)-1- propanamine",152261-43-3, REACH_data waiving | 28d rep dose tox study ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab9e73be-a931-4ac9-88bc-de5c13194a9b/documents/730c304d-7494-47c3-ab1e-366f7f403edb_8f3f92b0-2e20-499b-a123-36986f97f5df.html,,,,,, "Ethanol, 2,2'-oxybis-, reaction products with 3-(triethoxysilyl)-1- propanamine",152261-43-3, REACH_LD50 > 2000 mg/kg bw | rat (female) | OECD 423 | #key study##Analogy (152261-44 -4)# ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab9e73be-a931-4ac9-88bc-de5c13194a9b/documents/5aa770da-f5bf-48b6-8f35-8d1d2e01c257_8f3f92b0-2e20-499b-a123-36986f97f5df.html,,,,,, "Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. residues",68909-77-3,"Repeated dose toxicity - oral No adverse effects were observed in male and female rats in a 28 days and a 90 days repeated dose toxicity test conducted according to OECD 407 and OECD 408 respectively (Calvert Laboratories, Inc., 2011 and Envigo Research Limited, 2018) in which animals were exposed orally (gavage) to 0, 100, 500 or 1000 mg/kg bw/d (28 days study) and to 0, 10, 100 or 1000 mg/kg bw/d (90 days study). In both studies, an NOAEL of 1000 mg/kg bw was determined. In addition, in a 14 day repeated dose oral (gavage) range-finding toxicity study in rats (Wood, 2019), the administration of the test item at dose levels of 250, 500 and 1000 mg/kg bw/day resulted in no toxicologically significant effects being detected, as such, it was concluded that dose levels of up to 1000 mg/kg bw/day would be suitable for the 90-day repeated dose toxicity study. Repeated dose toxicity - dermal A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). The oral route of administration is considered to result in a higher systemic exposure and therefore be most predictive of the potential hazard. Therefore, it is not necessary to perform a repeated dose toxicity study via the dermal route of exposure . Repeated dose toxicity - inhalation A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). The oral route of administration is considered to result in a higher systemic exposure and therefore be most predictive of the potential hazard. Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation route of exposure. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): guideline studies ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7ae3c7d-a7db-4961-a91f-673bbd05488f/documents/b18ddd21-d98f-4dc0-854d-e0da64ad165b_724191c6-0fd6-43d2-a1ec-38093f5f16fe.html,,,,,, "Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. residues",68909-77-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7ae3c7d-a7db-4961-a91f-673bbd05488f/documents/b18ddd21-d98f-4dc0-854d-e0da64ad165b_724191c6-0fd6-43d2-a1ec-38093f5f16fe.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. residues",68909-77-3,"Acute oral toxicity : The oral LD50 in male and female Sprague-Dawley rats was determined to be 5000 mg/kg bw in a reliable, key study conducted similarly to OECD guideline 420 (Calvert Laboratories, Inc., 2010).Acute inhalation toxicity: No reliable data were available. However, this endpoint is waived for the inhalation route as specific data are available for the oral and dermal route.Acute dermal toxicity: In a reliable, key study conducted similarly to OECD guideline 402 and EPA OPPTS 870.1200, the acute dermal LD50 was determined to be greater than 2000 mg/kg bw in male and female Sprague-Dawley rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7ae3c7d-a7db-4961-a91f-673bbd05488f/documents/864c3db9-704f-4e41-8a72-fc3c525d0b77_724191c6-0fd6-43d2-a1ec-38093f5f16fe.html,,,,,, "Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. residues",68909-77-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7ae3c7d-a7db-4961-a91f-673bbd05488f/documents/864c3db9-704f-4e41-8a72-fc3c525d0b77_724191c6-0fd6-43d2-a1ec-38093f5f16fe.html,,oral,LD50,"5,000 mg/kg bw",adverse effect observed, "Ethanol, 2,2'-oxybis-, reaction products with ammonia, morpholine derivs. residues",68909-77-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7ae3c7d-a7db-4961-a91f-673bbd05488f/documents/864c3db9-704f-4e41-8a72-fc3c525d0b77_724191c6-0fd6-43d2-a1ec-38093f5f16fe.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "2-[(3-nitropyrazolo[1,5-a]pyridin-2-yl)oxy]ethanol",936103-10-5,Oral gavage LD50 in rat > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c58a2178-021f-404e-8e97-aef3dd4995ad/documents/IUC5-89c3d9b1-61d0-4314-9aa6-6556865d0211_3b428670-5e51-49d5-b8f0-c55751d3ed26.html,,,,,, "Ethanol, 2-amino-, reaction products with ammonia, by-products from",68910-05-4,Classification for acute toxicity: oral derived from individual component. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6da2de6d-c655-410b-98f9-4a7086ee860f/documents/f1e55d5d-0644-4fe3-89fe-e5304c50b887_8f56a4a5-1309-4334-95ad-fcf57891eff5.html,,,,,, "Ethanol, 2-ethoxy-, manufacture of, by-products from",161907-78-4,"ORAL NOAEL (mg/kgbw/day) rats90 day study: 75090 day study (substance 2-(2-(2-methoxyethoxy)ethoxy)ethanol: 400 (equivalent to 434 for substance in question)90 day study (substance 2-(2-ethoxyethoxy)ethanol: 800 (equivalent to 1062 for substance in question)DERMAL (rat, mg/kgbw/day)90 day study (substance 2-(2-(2-methoxyethoxy)ethoxy)ethanol: 4000 (equivalent to 4340 for substance in question) ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc2298ec-4925-491c-bccb-7690328aada3/documents/IUC5-dc4cde99-d7d6-48f6-aac6-80c75c26eeef_83d437ba-dfc8-4a27-85a6-754a9376b6a7.html,,,,,, "Ethanol, 2-ethoxy-, manufacture of, by-products from",161907-78-4,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc2298ec-4925-491c-bccb-7690328aada3/documents/IUC5-dc4cde99-d7d6-48f6-aac6-80c75c26eeef_83d437ba-dfc8-4a27-85a6-754a9376b6a7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,434 mg/kg bw/day,, "Ethanol, 2-ethoxy-, manufacture of, by-products from",161907-78-4,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc2298ec-4925-491c-bccb-7690328aada3/documents/IUC5-dc4cde99-d7d6-48f6-aac6-80c75c26eeef_83d437ba-dfc8-4a27-85a6-754a9376b6a7.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"6,100 mg/kg bw/day",, "Ethanol, 2-ethoxy-, manufacture of, by-products from",161907-78-4,ORAL - RATS (mg/kg): 10600DERMAL LD50 (mg/kg)TEGME read across substance: Rabbit: 7.45mg/kgTEGBE read across substance: Rabbit: 3.45ml/kg ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc2298ec-4925-491c-bccb-7690328aada3/documents/IUC5-f88f10df-0626-4a3e-bfe0-cbed990c4169_83d437ba-dfc8-4a27-85a6-754a9376b6a7.html,,,,,, "Ethanol, 2-ethoxy-, manufacture of, by-products from",161907-78-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc2298ec-4925-491c-bccb-7690328aada3/documents/IUC5-f88f10df-0626-4a3e-bfe0-cbed990c4169_83d437ba-dfc8-4a27-85a6-754a9376b6a7.html,,oral,LD50,"10,610 mg/kg bw",, "Ethanol, 2-methoxy-, manufacture of, by-products from, esters with boric acid",161907-80-8,The NOAEL in a 28 day rat study was approximately 380 mg B-TTEGME/kg bw/day based upon a toxicity study with Brake fluid up to 1000 mg/kg bw/day. No adverse findings were observed up to highest dose level. The study can be used to define an interim DNEL for hazard characterization until data from the proposed 90d study become available. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a161590-84f2-4101-b3a0-139783aec258/documents/IUC5-50cce33c-9939-4dac-bf5e-1a8ae434fcae_92e2ba42-8670-4e91-aa62-1a3da4dba761.html,,,,,, "Ethanol, 2-methoxy-, manufacture of, by-products from, esters with boric acid",161907-80-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a161590-84f2-4101-b3a0-139783aec258/documents/IUC5-50cce33c-9939-4dac-bf5e-1a8ae434fcae_92e2ba42-8670-4e91-aa62-1a3da4dba761.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,380 mg/kg bw/day,, "Ethanol, 2-methoxy-, manufacture of, by-products from, esters with boric acid",161907-80-8,"B-TTEGME in brake fluids was very well tolerated in rats after both acute oral and dermal dosing. Oral LD50 values were above the limit dose of 2000 mg/kg bw for B-TTEGME, whereas dermal LD50 values were above 1520 mg/kg bw . As also brake fluid and B-TEGME (component and read across compound) demonstrated LD50 values above 2000 mg/kg bw for oral and dermal acute toxicity, the acute safety profile of B-TTEGME is considered to be very safe. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a161590-84f2-4101-b3a0-139783aec258/documents/IUC5-9bcac32f-0bbc-4a4f-adb9-b99c5af050bb_92e2ba42-8670-4e91-aa62-1a3da4dba761.html,,,,,, 1-(3-Methyl-2-benzofuranyl)-ethanone,23911-56-0,"Acute oral toxicity The acute oral toxicity of the test item was tested according to OECD guideline 401. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley CD strain rat was found to be greater than 200 mg/kg but less than 2000 mg/kg bodyweight. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable without restrictions ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a106c8f-974e-46e8-8ba4-0737f79ba34f/documents/43fa429f-bb01-42cc-8197-055314145833_9721869c-a641-4426-8af0-97dedf84b5d9.html,,,,,, 1-(3-Methyl-2-benzofuranyl)-ethanone,23911-56-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a106c8f-974e-46e8-8ba4-0737f79ba34f/documents/43fa429f-bb01-42cc-8197-055314145833_9721869c-a641-4426-8af0-97dedf84b5d9.html,,oral,LD50,> 200 mg/kg bw,adverse effect observed, "(RS)-2,2-dichloro-1-(3-methyl-2,3-dihydro-4H-1,4-benzoxazin-4-yl)ethanone",98730-04-2,The repeated dose toxicity of benoxacor has been investigated in oral sub-chronic and chronic studies in rats and dogs and in a sub-acute dermal toxicity study in rabbits. There was no evidence of specific target organ toxicity in any of the studies that would warrant classification or labelling for this end-point. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1fbd1aaa-eacf-47db-b6d4-487da9a686f6/documents/IUC5-b3604f98-2659-417e-a7ae-1f6eda824696_29c1a79e-8f19-40b3-9912-2a2a27000e17.html,,,,,, "(RS)-2,2-dichloro-1-(3-methyl-2,3-dihydro-4H-1,4-benzoxazin-4-yl)ethanone",98730-04-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1fbd1aaa-eacf-47db-b6d4-487da9a686f6/documents/IUC5-b3604f98-2659-417e-a7ae-1f6eda824696_29c1a79e-8f19-40b3-9912-2a2a27000e17.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,010 mg/kg bw/day",,rabbit "(RS)-2,2-dichloro-1-(3-methyl-2,3-dihydro-4H-1,4-benzoxazin-4-yl)ethanone",98730-04-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1fbd1aaa-eacf-47db-b6d4-487da9a686f6/documents/IUC5-b3604f98-2659-417e-a7ae-1f6eda824696_29c1a79e-8f19-40b3-9912-2a2a27000e17.html,Chronic toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,dog "(RS)-2,2-dichloro-1-(3-methyl-2,3-dihydro-4H-1,4-benzoxazin-4-yl)ethanone",98730-04-2,"oral LD50 >5000 mg/kg, (Argus et al, 1986).dermal LD50 >2010 mg/kg, (Taberski et al., 1986).inhalation LC50 >2000 mg/m3, 4 hour, (Taberski et al., 1986).  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fbd1aaa-eacf-47db-b6d4-487da9a686f6/documents/IUC5-efedeea6-438e-4791-99f8-8a8e560a632b_29c1a79e-8f19-40b3-9912-2a2a27000e17.html,,,,,, "Ethene, homopolymer, oxidized, hydrolyzed, distn. residues, from C16-18 alcs. manuf.",1190630-03-5,"The key data is from a reliable (Klimisch 2) 26 week oral gavage study using docosan-1-ol in rats. In this study a NOAEL > 1000 mg/kg was reported. A read across from a reliable 13 week dietary study in rats using hexan-1-ol reported a NOAEL of 1127 mg/kg (Scientific Associates Inc., 1966). No adverse effects were noted at any of the dose levels administered during the study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2e5a9e8-5738-414b-97e8-acb9a855b508/documents/IUC5-e27d233c-109a-47f3-b492-f375feab44de_271cd1f3-b8d6-47b7-9985-51479e372c6f.html,,,,,, "Ethene, homopolymer, oxidized, hydrolyzed, distn. residues, from C16-18 alcs. manuf.",1190630-03-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2e5a9e8-5738-414b-97e8-acb9a855b508/documents/IUC5-e27d233c-109a-47f3-b492-f375feab44de_271cd1f3-b8d6-47b7-9985-51479e372c6f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, "Ethene, homopolymer, oxidized, hydrolyzed, distn. residues, from C16-18 alcs. manuf.",1190630-03-5,Oral¿ A reliable (Klimisch 1) OECD 401 GLP compliant study with icosan-1-ol. LD50 >10000mg/kg¿ A reliable (Klimisch 1) OECD 423 GLP compliant study with docosan1-1ol. LD50 >2000mg/kgDermal¿ A reliable (Klimisch 2) guideline equivalent acute dermal study was conducted with icosan-1ol in rabbits. The LD50 >20ml/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2e5a9e8-5738-414b-97e8-acb9a855b508/documents/IUC5-53aa9a9b-d97a-412f-a6f2-ae3e7002f73c_271cd1f3-b8d6-47b7-9985-51479e372c6f.html,,,,,, "Ethers, C5-6-branched alkyl Me",91995-60-7,"Data are available for the read-across substance TAME. A NOAEC of 250 ppm (1060 mg/m3) is selected for inhalation exposure based on the organ (liver, adrenals and kidneys) weight increases seen in the 90 day study with male and female F-344 rats.For the oral route, a NOAEL of 125 mg/kg bw/day is selected based on an increased adrenal (absolute and relative) and kidney (relative) weight at the higher doses in male rats in the 28 days study. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bbf74ee-0b94-41e3-a448-3a82b72caf6c/documents/IUC5-93bb3e10-a9a7-4d03-802e-90c730b39912_c25bdc33-679e-44a7-ba06-ac56e0120bba.html,,,,,, "Ethers, C5-6-branched alkyl Me",91995-60-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bbf74ee-0b94-41e3-a448-3a82b72caf6c/documents/IUC5-93bb3e10-a9a7-4d03-802e-90c730b39912_c25bdc33-679e-44a7-ba06-ac56e0120bba.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,, "Ethers, C5-6-branched alkyl Me",91995-60-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bbf74ee-0b94-41e3-a448-3a82b72caf6c/documents/IUC5-93bb3e10-a9a7-4d03-802e-90c730b39912_c25bdc33-679e-44a7-ba06-ac56e0120bba.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,060 mg/m3",, "Ethers, C5-6-branched alkyl Me",91995-60-7,"Data are available for the read-across substance TAME. One available oral study with rats resulted in a combined LD50 values of 2152 mg/kg. Females appeared to be more sensitive as the LD50 was 1602 mg/kg for females. For males the LD50 was 2417 mg/kg.The LC50 value via inhalation is over 5400 mg/m3 in rats.The LD50 value after dermal exposure was higher than 2000 mg/kg bw in rabbits.In humans, TAME caused slight acute toxic effects at concentrations of 15 (64 mg/m3) and 50 ppm (212 mg/m3). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bbf74ee-0b94-41e3-a448-3a82b72caf6c/documents/IUC5-7bd83a3f-1c2c-48cd-bc89-5bc7bda12807_c25bdc33-679e-44a7-ba06-ac56e0120bba.html,,,,,, "Ethoxybis(pentane-2,4-dionato-O,O')(propan-2-olato)titanium",68586-02-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1285f9b6-0370-45e2-9bd2-dbe3b7597629/documents/7e8a19f8-d31d-4bd2-b7e0-49a77fae8bae_f0885887-9dd7-4bb4-87f9-9454100c74ca.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,244 mg/kg bw/day,,rabbit "Ethoxybis(pentane-2,4-dionato-O,O')(propan-2-olato)titanium",68586-02-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1285f9b6-0370-45e2-9bd2-dbe3b7597629/documents/7e8a19f8-d31d-4bd2-b7e0-49a77fae8bae_f0885887-9dd7-4bb4-87f9-9454100c74ca.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,417 mg/m3,,rat "Ethoxybis(pentane-2,4-dionato-O,O')(propan-2-olato)titanium",68586-02-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1285f9b6-0370-45e2-9bd2-dbe3b7597629/documents/7e8a19f8-d31d-4bd2-b7e0-49a77fae8bae_f0885887-9dd7-4bb4-87f9-9454100c74ca.html,Chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Ethoxybis(pentane-2,4-dionato-O,O')(propan-2-olato)titanium",68586-02-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1285f9b6-0370-45e2-9bd2-dbe3b7597629/documents/d43f7f88-4542-4c91-bade-46eec715bf64_f0885887-9dd7-4bb4-87f9-9454100c74ca.html,,oral,LD50,570 mg/kg bw,adverse effect observed, "Ethoxybis(pentane-2,4-dionato-O,O')(propan-2-olato)titanium",68586-02-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1285f9b6-0370-45e2-9bd2-dbe3b7597629/documents/d43f7f88-4542-4c91-bade-46eec715bf64_f0885887-9dd7-4bb4-87f9-9454100c74ca.html,,dermal,LD50,790 mg/kg bw,adverse effect observed, "Ethoxybis(pentane-2,4-dionato-O,O')(propan-2-olato)titanium",68586-02-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1285f9b6-0370-45e2-9bd2-dbe3b7597629/documents/d43f7f88-4542-4c91-bade-46eec715bf64_f0885887-9dd7-4bb4-87f9-9454100c74ca.html,,inhalation,LC50,"5,006 mg/m3",adverse effect observed, Ethoxydiethylaluminium,1586-92-1,"Corrosive. Short chain aluminum alkyls ignite spontaneously on contact with air and therefore are classified pyrophoric. Reactions of aluminum alkyls with liquids are in some cases explosion like. Exposure of mammalian species to aluminum alkyls would not generate meaningful data, and no acute toxicity studies are required for this substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba3d8ca1-fe7a-48ed-b079-d159827b9216/documents/IUC5-b90979b7-61e9-415e-83c1-2ef990266135_218237c1-be65-429e-b127-28f926647d77.html,,,,,, Ethoxyquin,91-53-2," Repeated Dose Toxicity: Subchronic (90 days) study oral (gavage), rats (Sprague-Dawley) m/f (EPA OPP 82-1): NOAEL = 20 mg/kg bw/d (males), 40 mg/kg bw/d (females) (based on body weight and weight gain) Repeated Dose Toxicity: Subacute (28 days) study oral (gavage), rats (Sprague-Dawley) m/f (equivalent to OECD 407): NOAEL = 50 mg/kg bw/d (based on haematology, clinical biochemistry, histopathology) ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a1fea54-9c1f-4e3a-8dc8-1dc829a9fa22/documents/238a4ea1-7a30-4b91-8a2c-736ca6d6d2f4_0476e993-daa3-4b12-a775-71640ed12fd9.html,,,,,, Ethoxyquin,91-53-2,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a1fea54-9c1f-4e3a-8dc8-1dc829a9fa22/documents/238a4ea1-7a30-4b91-8a2c-736ca6d6d2f4_0476e993-daa3-4b12-a775-71640ed12fd9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat Ethoxyquin,91-53-2," Acute toxicity oral: LD50 = 1675 mg/kg bw (females), rat, m/f, oral: gavage (OECD 401, GLP) Acute toxicity inhalation: LC50 > 1.97 mg/L over 4h, rat, m/f, inhalation: aerosol, whole body (OECD 403, GLP) Acute toxicity dermal: LD50 > 2000 mg/kg bw, rat, m/f, semiocclusive (OECD 402, GLP) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a1fea54-9c1f-4e3a-8dc8-1dc829a9fa22/documents/766a0841-655c-486b-b3f0-d7c5ed1d814d_0476e993-daa3-4b12-a775-71640ed12fd9.html,,,,,, Ethoxyquin,91-53-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a1fea54-9c1f-4e3a-8dc8-1dc829a9fa22/documents/766a0841-655c-486b-b3f0-d7c5ed1d814d_0476e993-daa3-4b12-a775-71640ed12fd9.html,,oral,LD50,"1,675 mg/kg bw",adverse effect observed, Ethoxyquin,91-53-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a1fea54-9c1f-4e3a-8dc8-1dc829a9fa22/documents/766a0841-655c-486b-b3f0-d7c5ed1d814d_0476e993-daa3-4b12-a775-71640ed12fd9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethoxyquin,91-53-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a1fea54-9c1f-4e3a-8dc8-1dc829a9fa22/documents/766a0841-655c-486b-b3f0-d7c5ed1d814d_0476e993-daa3-4b12-a775-71640ed12fd9.html,,inhalation,,"1,970 mg/m3",no adverse effect observed, Ethoxytrimethylsilane,1825-62-3," Oral Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422), rat: NOAEL (systemic) = 150 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86b95081-9b32-4362-878c-589592592dab/documents/c3ffc59e-530f-4028-9bd1-621daf28a904_3c1fab27-40af-47f2-9bf8-91b2fd78996c.html,,,,,, Ethoxytrimethylsilane,1825-62-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86b95081-9b32-4362-878c-589592592dab/documents/c3ffc59e-530f-4028-9bd1-621daf28a904_3c1fab27-40af-47f2-9bf8-91b2fd78996c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Ethoxytrimethylsilane,1825-62-3," Oral (OECD 423), rat: LD50 > 2000 mg/kg bw Inhalation (OECD 436), rat: LC50 > 20.57 mg/L ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86b95081-9b32-4362-878c-589592592dab/documents/27c0eda1-0384-4516-bae7-35d94e73b683_3c1fab27-40af-47f2-9bf8-91b2fd78996c.html,,,,,, Ethoxytrimethylsilane,1825-62-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86b95081-9b32-4362-878c-589592592dab/documents/27c0eda1-0384-4516-bae7-35d94e73b683_3c1fab27-40af-47f2-9bf8-91b2fd78996c.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Ethoxytrimethylsilane,1825-62-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86b95081-9b32-4362-878c-589592592dab/documents/27c0eda1-0384-4516-bae7-35d94e73b683_3c1fab27-40af-47f2-9bf8-91b2fd78996c.html,,inhalation,LC50,> 20.57 mg/L,adverse effect observed, "ethyl (3-benzoyl-2,4,6-trimethylbenzoyl)(phenyl)phosphinate",1539267-56-5,"Only one acute toxicity is available on ethyl (3-benzoyl-2,4,6-trimethylbenzoyl)(phenyl)phosphinate : the acute oral LD0 was determined to be higher than 2 000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): A single study is available. The study was conducted in accordance with standardised guidelines and under GLP conditions and was therefore awarded a Klimisch reliability score of 1. The quality of the database is therefore considered to be high. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f76e434-82b0-4785-932b-fe019d8fa1d5/documents/6a24759f-729e-46cc-b7e9-eb39fb7c595b_6e8d1a9d-626c-4427-b297-591efa632610.html,,,,,, "ethyl (3-benzoyl-2,4,6-trimethylbenzoyl)(phenyl)phosphinate",1539267-56-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f76e434-82b0-4785-932b-fe019d8fa1d5/documents/6a24759f-729e-46cc-b7e9-eb39fb7c595b_6e8d1a9d-626c-4427-b297-591efa632610.html,,oral,LD0,"2,000 mg/kg bw",no adverse effect observed, Ethyl (S)-2-hydroxypropionate,687-47-8," Two sub-acute inhalation toxicity studies with ethyl (S)-lactate revealed clear respiratory local effects, described as histopathological changes in the olfactory and respiratory epitheliums. No clear systemic toxic effects were detected. There are no reliable studies available for the assessment of the sub-chronic repeated dose toxicity with the target substance ethyl (S)-lactate. Therefore, available data from an oral sub-chronic repeated dose toxicity study conducted with a suitable read-across partner, calcium lactate, was used to assess the specific target organ toxicity of the target substance. High levels of exposure to calcium lactate in the diet (up to 30% in feed) did not lead to any lactate-associated effects after sub-chronic exposure. In addition, in an sub-chronic repeated dose toxicity, ethanol was administered to Fischer 344 rats/sex/dose via oral feed ad libitum at dose levels of 0, 1, 2, 3, 4, 5 and 10% for 13 weeks. Based on the results, the NOAEL can be considered to be 2%, which is calculated to be equivalent to 2400 mg/kg bw/day, This dose is much higher as the limit dose of 1000 mg/kg bw/day mentioned in the OECD TG 408. In summary, no classification for specific target organ toxicity is warranted for the target substance. For details and justification of read-across please refer to the report attached in section 13 of IUCLID. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aaa4169c-f5d5-4447-8fe1-c7b9de2e87ba/documents/IUC5-b1c39b4c-d072-4f66-9ad7-40afe06c40b2_015f4572-9542-438a-846d-a8cd1c9449ff.html,,,,,, Ethyl (S)-2-hydroxypropionate,687-47-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aaa4169c-f5d5-4447-8fe1-c7b9de2e87ba/documents/IUC5-b1c39b4c-d072-4f66-9ad7-40afe06c40b2_015f4572-9542-438a-846d-a8cd1c9449ff.html,Repeated dose toxicity – local effects,inhalation,NOAEC,150 mg/m3,adverse effect observed,rat Ethyl (S)-2-hydroxypropionate,687-47-8,"In an acute oral toxicity study conducted according to OECD guideline 401, groups of Wistar rats (5/sex) were given Ethyl (S)-lactate (99.5 % purity) as a single oral dose of 2000 mg/kg bw. No mortality occurred and an oral LD50 value of greater than 2000 mg/kg bw, both in male and female rats, was determined in this study. In an acute inhalation study conducted according to OECD guideline 403, groups of Wistar rats (5/sex) were exposed to 5.4 mg/L Ethyl lactate for 4 hours. No mortality occurred and thus the LC50 can be considered to be greater than 5.4 mg/L. In an acute inhalation toxicity study, young adult Wistar rats (5/sex), were exposed to aerosols of Ethyl lactate at a concentration of 5.4 mg/L in air for 4 hours. No mortality occurred and based on the result from this key study, the LC50 is considered to be greater than 5.14 mg/L. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Guideline study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Guideline study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aaa4169c-f5d5-4447-8fe1-c7b9de2e87ba/documents/IUC5-b36bdb68-a19a-4c13-b8e6-47bd622b5a03_015f4572-9542-438a-846d-a8cd1c9449ff.html,,,,,, Ethyl (S)-2-hydroxypropionate,687-47-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aaa4169c-f5d5-4447-8fe1-c7b9de2e87ba/documents/IUC5-b36bdb68-a19a-4c13-b8e6-47bd622b5a03_015f4572-9542-438a-846d-a8cd1c9449ff.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Ethyl (S)-2-hydroxypropionate,687-47-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aaa4169c-f5d5-4447-8fe1-c7b9de2e87ba/documents/IUC5-b36bdb68-a19a-4c13-b8e6-47bd622b5a03_015f4572-9542-438a-846d-a8cd1c9449ff.html,,inhalation,LC50,"> 5,400 mg/m3",no adverse effect observed, Ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate,17243-69-5,"In an acute oral toxic class method (OECD 423 guideline study, GLP compliant) the LD50 of a structural analogous of ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate was determined to be greater than 300 mg/kg bw and less than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14219cde-dda3-4002-8886-fb23b49db838/documents/IUC5-d0c1c5a1-f23c-413b-939d-ab0df5da0f80_21758f80-bf4e-4ec5-a9a0-e3e57f42f236.html,,,,,, Ethyl 2-(dimethylamino)-1-phenylcyclohex-3-ene-1-carboxylate,17243-69-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14219cde-dda3-4002-8886-fb23b49db838/documents/IUC5-d0c1c5a1-f23c-413b-939d-ab0df5da0f80_21758f80-bf4e-4ec5-a9a0-e3e57f42f236.html,,oral,LD50,500 mg/kg bw,adverse effect observed, ethyl 2-acetyl-4-methyltridec-2-enoate,960253-23-0," OECD 422, GLP study (rat, gavage): NOAEL parental systemic toxicity = 400 mg/kg bw/d (males) NOAEL parental systemic toxicity = 800 mg/kg bw/d (females) NOAEL neonatal toxicity = 400 mg/kg bw/d (males and females) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e0989c2-37a8-47af-adc0-e544cc413e3f/documents/f5766551-e7a9-4eb3-b8aa-55ab887f1331_86b53662-7579-43d8-803c-1017c9529cf8.html,,,,,, ethyl 2-acetyl-4-methyltridec-2-enoate,960253-23-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e0989c2-37a8-47af-adc0-e544cc413e3f/documents/f5766551-e7a9-4eb3-b8aa-55ab887f1331_86b53662-7579-43d8-803c-1017c9529cf8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat ethyl 2-acetyl-4-methyltridec-2-enoate,960253-23-0," Acute oral toxicity of Scentaurus Clean (GR-86 -6599): Assessment of acute oral toxicity with GR-86-6599 in the rat (Acute Toxic Class Method). The study was carried out based on the guidelines described in: - OECD No.423 (2001) ""Acute Oral Toxicity, Acute Toxic Class Method"" - Commission Regulation (EC) No 440/2008, B1 tris: ""Acute Oral Toxicity, Acute Toxic Class Method"" - EPA, OPPTS 870.1100 (2002), ""Acute Oral Toxicity"" JMAFF Guidelines (2000), including the most recent revisions. The oral LD50 value of GR-86-6599 in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight as no mortality occurred. Acute inhalation toxicity of Scentaurus Clean (GR-86 -6599): The study was carried out based on the guidelines described in: • OECD Guidelines, Section 4, Health Effects. No.403, ""Acute Inhalation Toxicity"", Sep 2009. • Commission Regulation (EC) No 440/2008, B.2. Acute Toxicity (inhalation), L142, May 2008. • EPA OPPTS 870.1300, Acute inhalation Toxicity. EPA 712-C-98-193, August 1998. • JMAFF Guidelines (2000), including the most recent revisions. The inhalation LC50, 4h value of GR-86-6599 in Wistar rats was established to be within the range of 1 – 5 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e0989c2-37a8-47af-adc0-e544cc413e3f/documents/99c37c03-507b-403c-b5c3-9e115c6c3509_86b53662-7579-43d8-803c-1017c9529cf8.html,,,,,, ethyl 2-acetyl-4-methyltridec-2-enoate,960253-23-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e0989c2-37a8-47af-adc0-e544cc413e3f/documents/99c37c03-507b-403c-b5c3-9e115c6c3509_86b53662-7579-43d8-803c-1017c9529cf8.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, ethyl 2-acetyl-4-methyltridec-2-enoate,960253-23-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e0989c2-37a8-47af-adc0-e544cc413e3f/documents/99c37c03-507b-403c-b5c3-9e115c6c3509_86b53662-7579-43d8-803c-1017c9529cf8.html,,inhalation,LC50,"> 1,000,000 ",adverse effect observed, Ethyl 2-bromo-2-methylpropionate,600-00-0,Ethyl 2-bromoisobutyrate has not to be considered as harmful since acute oral or dermal toxicity tests didn't show any mortality rate in rats below a concentration of 2000 mg/kg bodyweight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf339e92-15ba-47d2-b25f-422beced3046/documents/IUC5-43e73ff8-5404-48a0-bbc0-b91b824594ce_721d93ba-146e-4d52-848a-255df2e2261e.html,,,,,, Ethyl 2-bromo-2-methylpropionate,600-00-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf339e92-15ba-47d2-b25f-422beced3046/documents/IUC5-43e73ff8-5404-48a0-bbc0-b91b824594ce_721d93ba-146e-4d52-848a-255df2e2261e.html,,oral,LD50,"2,000 mg/kg bw",, Ethyl 2-bromo-2-methylpropionate,600-00-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf339e92-15ba-47d2-b25f-422beced3046/documents/IUC5-43e73ff8-5404-48a0-bbc0-b91b824594ce_721d93ba-146e-4d52-848a-255df2e2261e.html,,dermal,LD50,"2,000 mg/kg bw",, "Ethyl 3,5-dichloro-4-hexadecyloxycarbonyloxybenzoate",115895-09-5,"Oral: NOAEL (rat, 28d, OECD 407) = 205 mg/kg bw/day, males and 1373 mg/kg bw/day, females ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03bf7e9c-6fee-42bc-a851-1e4cd596a946/documents/6b2dd96e-4804-4259-9dd2-7c7e5718ead2_ca849f68-8406-4df7-bf8d-9978c867a46e.html,,,,,, "Ethyl 3,5-dichloro-4-hexadecyloxycarbonyloxybenzoate",115895-09-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03bf7e9c-6fee-42bc-a851-1e4cd596a946/documents/6b2dd96e-4804-4259-9dd2-7c7e5718ead2_ca849f68-8406-4df7-bf8d-9978c867a46e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,205 mg/kg bw/day,,rat "Ethyl 3,5-dichloro-4-hexadecyloxycarbonyloxybenzoate",115895-09-5,"Oral (OECD 401), rat: LD50 > 5000 mg/kg bw (limit test)Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw (limit test)   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03bf7e9c-6fee-42bc-a851-1e4cd596a946/documents/IUC5-374e0986-c2a6-4882-a9d9-8a9edda65376_ca849f68-8406-4df7-bf8d-9978c867a46e.html,,,,,, "Ethyl 3,5-dichloro-4-hexadecyloxycarbonyloxybenzoate",115895-09-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03bf7e9c-6fee-42bc-a851-1e4cd596a946/documents/IUC5-374e0986-c2a6-4882-a9d9-8a9edda65376_ca849f68-8406-4df7-bf8d-9978c867a46e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Ethyl 3,5-dichloro-4-hexadecyloxycarbonyloxybenzoate",115895-09-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03bf7e9c-6fee-42bc-a851-1e4cd596a946/documents/IUC5-374e0986-c2a6-4882-a9d9-8a9edda65376_ca849f68-8406-4df7-bf8d-9978c867a46e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl 3-[[bis(1-methylethoxy)phosphinothioyl]thio]propionate,71735-74-5," In a 28 day study (Harlan, 2012), hepatocellular hypertrophy was observed histologically in males dosed with 500 mg/kg bw/day, which was considered to be an adaptive change due to increased metabolic load. Increased incidence and severity of tubular basophilia in the kidneys were observed in females at 500 mg/kg bw/day. The NOAEL was considered to be 250 mg/kg bw/day for females and 500 mg/kg bw/day for males. In a subchronic toxicity study with a structural analogue, an adaptive liver enlargement at doses of 450 - 500 mg/kg bw was observed. The NOEL was 125 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/99412f58-385c-457d-a1f0-f9b48603b240/documents/IUC5-47419a3f-b1c1-4656-9fbd-b1238b502438_f20e9e8e-b8da-4407-b9d4-a38bf56564c9.html,,,,,, Ethyl 3-[[bis(1-methylethoxy)phosphinothioyl]thio]propionate,71735-74-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/99412f58-385c-457d-a1f0-f9b48603b240/documents/IUC5-47419a3f-b1c1-4656-9fbd-b1238b502438_f20e9e8e-b8da-4407-b9d4-a38bf56564c9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Ethyl 3-[[bis(1-methylethoxy)phosphinothioyl]thio]propionate,71735-74-5, In an acute oral toxicity study the oral LD50 was determined to be greater than 5000 mg/kg body weight. An acute dermal test with a structural analogue did not cause mortality upon single dermal application of 2000 mg/kg bw as tested in a GLP-compliant study following OECD testing guideline 402 (1987). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99412f58-385c-457d-a1f0-f9b48603b240/documents/IUC5-7f5758da-88a5-40a3-8609-3974d5645001_f20e9e8e-b8da-4407-b9d4-a38bf56564c9.html,,,,,, Ethyl 3-[[bis(1-methylethoxy)phosphinothioyl]thio]propionate,71735-74-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99412f58-385c-457d-a1f0-f9b48603b240/documents/IUC5-7f5758da-88a5-40a3-8609-3974d5645001_f20e9e8e-b8da-4407-b9d4-a38bf56564c9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Ethyl 3-[[bis(1-methylethoxy)phosphinothioyl]thio]propionate,71735-74-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99412f58-385c-457d-a1f0-f9b48603b240/documents/IUC5-7f5758da-88a5-40a3-8609-3974d5645001_f20e9e8e-b8da-4407-b9d4-a38bf56564c9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Ethyl 4,4,4-trifluoroacetoacetate",372-31-6,ACUTE ORAL TOXICITY:A study was carried out according to EU Method B.1 and OECD Guideline 401 (Acute Oral Toxicity) on Albino Wistar rats. The acute oral LD50 of P5117 on Wistar rats was found to be: - combined males and females: 855 mg/kg - males: 954 mg/kg - females: 765 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40a26c92-b632-4ecf-b697-c860bc4059a0/documents/IUC5-c00d122d-72b2-4d06-a802-0ea20a99f69a_42681d85-9e38-4236-a7c3-de57ccc32dd9.html,,,,,, "Ethyl 4,4,4-trifluoroacetoacetate",372-31-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40a26c92-b632-4ecf-b697-c860bc4059a0/documents/IUC5-c00d122d-72b2-4d06-a802-0ea20a99f69a_42681d85-9e38-4236-a7c3-de57ccc32dd9.html,,oral,LD50,765 mg/kg bw,adverse effect observed, Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate,57834-33-0, The NOAEL of Eversorb EP4 was 10 mg/kg/day (OECD TG407). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20fdaef6-49f1-4d4f-a51c-7855c3945028/documents/77277d20-ed84-4896-83cd-13ee6efb7a43_2f010456-491d-4d53-9e7f-11ff6c5bf7b0.html,,,,,, Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate,57834-33-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20fdaef6-49f1-4d4f-a51c-7855c3945028/documents/77277d20-ed84-4896-83cd-13ee6efb7a43_2f010456-491d-4d53-9e7f-11ff6c5bf7b0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate,57834-33-0, Acute toxicity: via oral route The LD50 of the test substance was greater than 2000 mg/kg B.W. (OECD TG423).   Acute toxicity: via dermal route The LD50 of the test substance was greater than 2000 mg/kg B.W. (OECD TG402). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20fdaef6-49f1-4d4f-a51c-7855c3945028/documents/7d67e27f-5878-44ee-9eb8-898d8defdd13_2f010456-491d-4d53-9e7f-11ff6c5bf7b0.html,,,,,, Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate,57834-33-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20fdaef6-49f1-4d4f-a51c-7855c3945028/documents/7d67e27f-5878-44ee-9eb8-898d8defdd13_2f010456-491d-4d53-9e7f-11ff6c5bf7b0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl 4-[[(methylphenylamino)methylene]amino]benzoate,57834-33-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20fdaef6-49f1-4d4f-a51c-7855c3945028/documents/7d67e27f-5878-44ee-9eb8-898d8defdd13_2f010456-491d-4d53-9e7f-11ff6c5bf7b0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl 4-chloroacetoacetate,638-07-3," Repeated dose toxicity (90 d, feeding) A feeding study was carried out according to OECD Guideline 409 on Wistar rats (l0 anirnals/sex/group over a test period of 90 days. The appropriate dose levels were determined in 14 -d range finding study. The dose levels in the main study were 0, 0.0085, 0.0847 and 0.8469 g/kg f'eed, equal to cornpound intake of 0, 0.57, 5.66 and 56.06 mg/kg/d for males and 0, 0.64, 6.24 and 64.98 mg/kg/d for females. There was no mortality observed during the study. Clinical signs included symptoms of depression, reduction in activity and reduced food consumption were observed in mid sand high dose groups. Body weights, food consumption and food efficiency were statistically decreased in mid and high dose groups mainly in both sexes starting from week 3 of the dosing period. A number of changes were noted in blood parameters of the mid and high dose animals. These findings included decrease in blood cell counts, increase in hemtocrit values, decrease in lymphocytes, decrease of creatinine concentrations etc. Changes on kidney-to-body-weight ratios and brain-to-body-weight ratios were seen in mid and/or high dose groups on females. Histopathological examination showed a number of effects in some animals of mid and high dose groups, such as large number of inflammatory cells in rat epididymis. Based on these results, the NOAEL (No-Observed-Adverse-Effect-Level) was 0.57 mg/kg/d for males and 0.64 mg/kg/d for females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/726017f7-764e-4c6a-b104-1c8b5314b364/documents/e39c1d6f-036a-407d-947a-2d78331e06c5_8506cc7e-dd8f-40eb-9f35-f73055753877.html,,,,,, Ethyl 4-chloroacetoacetate,638-07-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/726017f7-764e-4c6a-b104-1c8b5314b364/documents/e39c1d6f-036a-407d-947a-2d78331e06c5_8506cc7e-dd8f-40eb-9f35-f73055753877.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.57 mg/kg bw/day,,rat Ethyl 4-chloroacetoacetate,638-07-3," Acute oral toxicity A study was carried out according to the Chinese guidelines for the testing of chemicals (similar to OECD-guideline no. 401) on Albino Wistar rats. Dose groups of 100, 215, 464 and 1000 mg/kg were tested (5 male, 5 female per dose group). The test item was dissolved in peanut oil. and administered orally by gavage. 0% mortality was noted at 100 mg/kg, 20% at 215 mg/kg and 100% at 464 mg/kg and above. Clinical symptoms included dispirited prostration, ruffled fur, bloody secretion in nose and dirty perineum 48 hours after administration. Mortality occured between days 2 and 7. Surviving animals recovered within days 4 -6. In conclusion, the acute oral LD50 on rats was calculated to be 271 mg/kg. Further studies are available on rabbits, mice and rats; their LD50 are in the range of 46-500 mg/kg. However, quality of these studies is rather low and therefore the tests were not further evaluated. Acute inhalation toxicity A study was carried out according to the Chinese guidelines for the testing of chemicals (similar to OECD-guideline no. 403) on Wistar rats. Animals were exposed to test item vapor for 4 hours at concentrations of 1.00, 2.15, 4.64 and 10:00 mg/l. After administration, rats were observed fpr 14 days. Symptoms of prostration, sweating, lying, bloody secretions in mouth and nose, sthma, perineal secretions were noted in males and females after administration. Mortalities occured within 24 hours, whereas the surviving animals gradually recovered between days 2 and 6.. In conclusion, the acute inhalative LC50 was 4.30 mg/l. Acute dermal toxicity A study was carried out according to EU Method B.2 and OECD Guideline 402 (Acute Dermal Toxicity) on Albino Wistar rats. Dose groups of 50, 400 and 2000 mg/kg were tested (5 male and 5 female at 50 mg/kg, 2 females only at 400 and 2000 mg/kg). The test item was suspended in maize oil and administered dermally for 24 hours. 0% mortality was noted at 50 mg/kg, 50% at 400 mg/kg and 100% at 2000 mg/kg. Clinical symptoms included sluggishness, hunching, blepharospasm, pallor and vocalization. Skin effects observed consisted of erythema, encrustations and oedema. Macroscopic examination of surviving animals at the end of the observation period did not reveal any abnormalities. The acute dermal LD50 was therefore considered to be between 50 and 400 mg/kg in both males and females. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/726017f7-764e-4c6a-b104-1c8b5314b364/documents/102035ca-3a9c-4f47-a2e3-a08546a145af_8506cc7e-dd8f-40eb-9f35-f73055753877.html,,,,,, Ethyl 4-chloroacetoacetate,638-07-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/726017f7-764e-4c6a-b104-1c8b5314b364/documents/102035ca-3a9c-4f47-a2e3-a08546a145af_8506cc7e-dd8f-40eb-9f35-f73055753877.html,,oral,LD50,271 mg/kg bw,adverse effect observed, Ethyl 4-chloroacetoacetate,638-07-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/726017f7-764e-4c6a-b104-1c8b5314b364/documents/102035ca-3a9c-4f47-a2e3-a08546a145af_8506cc7e-dd8f-40eb-9f35-f73055753877.html,,inhalation,LC50,"4,300 mg/m3",no adverse effect observed, Ethyl 4-methyl-2-oxocyclohexanecarboxylate,13537-82-1," It was concluded that 12500 ppm (equivalent to approximately 917 and 869 mg/kg/day in males and females, respectively) mg/kg/day represented the no-observed-adverse-effect level (NOAEL) when administered in the diet for 28 consecutive days to the rat. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92209a02-73dc-4e92-9658-63d3cd941269/documents/35907585-ad03-4fdd-a849-35b69766dbcb_40803b45-68bb-418e-8ed0-fbcbcbd41279.html,,,,,, Ethyl 4-methyl-2-oxocyclohexanecarboxylate,13537-82-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92209a02-73dc-4e92-9658-63d3cd941269/documents/35907585-ad03-4fdd-a849-35b69766dbcb_40803b45-68bb-418e-8ed0-fbcbcbd41279.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,869 mg/kg bw/day,,rat Ethyl 4-methyl-2-oxocyclohexanecarboxylate,13537-82-1, Acute oral toxicity: OECD TG 423: LD50 > 2000 mg/kg bw Acute dermal toxicity: OECD TG 402: LD50 > 2000 mg/kg bw Acute inhalation toxicity: OECD 403: LC50 > 5 g/m3 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92209a02-73dc-4e92-9658-63d3cd941269/documents/4a2517aa-f7cc-4cc3-b710-3ebf08a2af0d_40803b45-68bb-418e-8ed0-fbcbcbd41279.html,,,,,, Ethyl 4-methyl-2-oxocyclohexanecarboxylate,13537-82-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92209a02-73dc-4e92-9658-63d3cd941269/documents/4a2517aa-f7cc-4cc3-b710-3ebf08a2af0d_40803b45-68bb-418e-8ed0-fbcbcbd41279.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl 4-methyl-2-oxocyclohexanecarboxylate,13537-82-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92209a02-73dc-4e92-9658-63d3cd941269/documents/4a2517aa-f7cc-4cc3-b710-3ebf08a2af0d_40803b45-68bb-418e-8ed0-fbcbcbd41279.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl 4-methyl-2-oxocyclohexanecarboxylate,13537-82-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92209a02-73dc-4e92-9658-63d3cd941269/documents/4a2517aa-f7cc-4cc3-b710-3ebf08a2af0d_40803b45-68bb-418e-8ed0-fbcbcbd41279.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Ethyl 4-piperidinecarboxylate,1126-09-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b49c64a7-efe8-47d1-9a9b-0fe5fb4d378e/documents/9ef32026-f846-44e0-9560-851910825817_be26757c-c323-48cf-b577-c8e57d43fbf1.html,,oral,LD50,"5,000 mg/kg bw",adverse effect observed, Ethyl 5-sulphamoyl-o-anisate,33045-53-3, Acute oral toxicity: Key study: OECD 423 and EU method B.1 tris. GLP study. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd9b22c9-6a75-406e-8cda-1f8365c9bf2d/documents/da4a21ce-3612-4cc2-810e-c4c3660a0d7b_39025039-52d2-41a3-812d-10306c8b1de3.html,,,,,, Ethyl 5-sulphamoyl-o-anisate,33045-53-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd9b22c9-6a75-406e-8cda-1f8365c9bf2d/documents/da4a21ce-3612-4cc2-810e-c4c3660a0d7b_39025039-52d2-41a3-812d-10306c8b1de3.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Ethyl 6,8-dichlorooctanoate",1070-64-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): one short term repeated dose toxicity study has been performed according to guideline. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/851d8bad-2dda-486d-b0ec-7fea24bf5ca3/documents/cc90e67f-1e10-4c6f-9e74-68e057acab45_773f4ac1-977f-4b42-bf5c-a684e32e3063.html,,,,,, "Ethyl 6,8-dichlorooctanoate",1070-64-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/851d8bad-2dda-486d-b0ec-7fea24bf5ca3/documents/cc90e67f-1e10-4c6f-9e74-68e057acab45_773f4ac1-977f-4b42-bf5c-a684e32e3063.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat "Ethyl 6,8-dichlorooctanoate",1070-64-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): one study prepared accoding to guideline is available Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Not study necessary for tonnage band 1-10t Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): one study prepared accoding to guideline is available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/851d8bad-2dda-486d-b0ec-7fea24bf5ca3/documents/a8038af7-440b-4db1-b147-0ba86781a91d_773f4ac1-977f-4b42-bf5c-a684e32e3063.html,,,,,, "Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate",68109-88-6,"ORALNOAEL = 5 mg/kg diet (based on the effects noted in the thymus) in the rat, equivalent to 0.3-0.4 mg/kg bw/day for male animals and 0.3-0.5 mg/kg bw/day for female animals, OECD 422, Waalkens-Berendsen 2004 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a12d1fa-a8f9-446f-a790-cd28b6287b90/documents/IUC5-8120ed03-794f-43a3-9f2f-8d3e276f7d33_6aa64fc9-818a-4da6-bc67-fc5c8b688b2c.html,,,,,, "Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate",68109-88-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a12d1fa-a8f9-446f-a790-cd28b6287b90/documents/IUC5-8120ed03-794f-43a3-9f2f-8d3e276f7d33_6aa64fc9-818a-4da6-bc67-fc5c8b688b2c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,0.3 mg/kg bw/day,,rat "Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate",68109-88-6,"ACUTE ORAL TOXICITYLD50 = 3793 mg/kg, male/female rat, OECD 401, Sarasin 1982ACUTE DERMAL TOXICITYLD50 = >2000 mg/kg bw, male/female rat, OECD 402, EU Method B.3, Sanders 2012 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a12d1fa-a8f9-446f-a790-cd28b6287b90/documents/IUC5-ef4ddfa3-1e31-4fa7-874b-ed4cd0404278_6aa64fc9-818a-4da6-bc67-fc5c8b688b2c.html,,,,,, "Ethyl 9,9-dioctyl-4,7,11-trioxo-3,8,10-trioxa-9-stannatetradeca-5,12-dien-14-oate",68109-88-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a12d1fa-a8f9-446f-a790-cd28b6287b90/documents/IUC5-ef4ddfa3-1e31-4fa7-874b-ed4cd0404278_6aa64fc9-818a-4da6-bc67-fc5c8b688b2c.html,,oral,LD50,"3,793 mg/kg bw",no adverse effect observed, Ethyl chloroacetate,105-39-5,"Key studies: Experimental studies conducted with the substance ethyl chloroacetate: LD50 oral (rat) = 180 mg/kg bw (no guideline was followed but the test method was similar to OECD 401). LD50 dermal (rat) = 161,2 mg/kg bw (no guideline was followed but the test method was similar to OECD 402). LC50 inhalation (rat) = 3.33 ml/m3 (no guideline was followed but the test method was similar to OECD 403). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b152d64-ed14-4cae-b445-335e46f8c94a/documents/IUC5-5c01a8b4-53f9-43b1-825d-861ca677a8fa_4fd77d9d-35a4-4127-b359-8e513ae057f8.html,,,,,, Ethyl chloroacetate,105-39-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b152d64-ed14-4cae-b445-335e46f8c94a/documents/IUC5-5c01a8b4-53f9-43b1-825d-861ca677a8fa_4fd77d9d-35a4-4127-b359-8e513ae057f8.html,,oral,LD50,180 mg/kg bw,, Ethyl chloroacetate,105-39-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b152d64-ed14-4cae-b445-335e46f8c94a/documents/IUC5-5c01a8b4-53f9-43b1-825d-861ca677a8fa_4fd77d9d-35a4-4127-b359-8e513ae057f8.html,,dermal,LD50,161.2 mg/kg bw,, Ethyl chloroacetate,105-39-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b152d64-ed14-4cae-b445-335e46f8c94a/documents/IUC5-5c01a8b4-53f9-43b1-825d-861ca677a8fa_4fd77d9d-35a4-4127-b359-8e513ae057f8.html,,inhalation,LC50,"3,800 mg/m3",, Ethyl chloroformate,541-41-3,inhalation is the relevant rout of exposure for this volatile substance. There were no signs of toxicity in rats exposed to 4.5 mg/m³ (1 ppm = NOAEC) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b6f3480-df9c-48ad-9686-d0cea87a4bd9/documents/IUC5-611e4405-92a4-4ac2-bfbd-28cda9234f57_1936e603-b71a-4a8f-9ae5-7afd01152bf5.html,,,,,, Ethyl chloroformate,541-41-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b6f3480-df9c-48ad-9686-d0cea87a4bd9/documents/IUC5-611e4405-92a4-4ac2-bfbd-28cda9234f57_1936e603-b71a-4a8f-9ae5-7afd01152bf5.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,4.5 mg/m3,,rat Ethyl chloroformate,541-41-3,"The 1-hr LC50 values for males and females were 0.84) mg/L and 0.89 mg/L, respectively (--> 4h LC50 = 0.43 mg/L). Ethylchloroformate is toxic at inhalative exposure. The dermal LD50 value was greater than 2280 mg/kg bw. The oral LD50 value of ethylchloroformate is in the range of 205- 614 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b6f3480-df9c-48ad-9686-d0cea87a4bd9/documents/IUC5-3cd71c80-e91c-4f3c-9321-e063c5eaadf5_1936e603-b71a-4a8f-9ae5-7afd01152bf5.html,,,,,, Ethyl cyanoacetate,105-56-6,"Ethyl cyanoacetate has been dosed to rats (male/female). Symptoms of poisoning were recorded such as ruffled fur, changes in gait, sedation or ataxia, decreased motility, tremor, vocalization, stagger, increased respiratory frequency. Other clinical signs included hunched posture, pilo-erection, lethargy, decreased respiratory rate and ataxia. The symptoms were reversible in all studies. No mortality was observed.The substance is not acute orally toxic: LD50 > 2000 mg/kg bw and no acute oral classification is needed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2579ff9b-7aa3-41d3-acd5-476a3d0e7116/documents/007de520-4667-4fc3-9664-2b87ec692acd_f24b11fc-b70b-42a5-9e83-6a8286fe15f9.html,,,,,, Ethyl cyanoacetate,105-56-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2579ff9b-7aa3-41d3-acd5-476a3d0e7116/documents/007de520-4667-4fc3-9664-2b87ec692acd_f24b11fc-b70b-42a5-9e83-6a8286fe15f9.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Ethyl diphenylcarbamate,603-52-1, Key study: OECD 423. GLP study. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off of the test item may be considered to be higher than 5000 mg/kg body weight by oral route in the rat. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bbf3ce9-590a-4af2-a9bc-45b53309b5d0/documents/b1bba3cd-16b5-42f0-8d17-096086e67e43_4979680c-bf1a-4a39-8227-b2e64f407f55.html,,,,,, Ethyl diphenylcarbamate,603-52-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bbf3ce9-590a-4af2-a9bc-45b53309b5d0/documents/b1bba3cd-16b5-42f0-8d17-096086e67e43_4979680c-bf1a-4a39-8227-b2e64f407f55.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Ethyl diphenylphosphinite,719-80-2,"Oral:Rat LD50 male = 681mg/kg b.w., female = 316mg/kg b.w. (BASF 1982, acc. to OECD401)Inhalation (Vapor):Rat: LC0 >= saturated air (BASF 1982, inhalation risk test)I.p.Rat: LD50 male= 1002mg/kg b.w., female = 508mg/kg b.w. (BASF 1982) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60c9842c-5d37-4000-9879-520684cae90f/documents/IUC5-bb6ec0b3-2cfe-4f3d-806a-b6ccd84f0d01_63051a0a-d07e-4ca7-a228-b6b232298dca.html,,,,,, Ethyl ethyl(phenyl)carbamate,1013-75-8," Acute oral toxicity: Kedy study: GLP Study and OECD TG 423. The LD50 of the test item is higher than 2000 mg/kg bw by oral route in the rat, therefore the test item  does not have to be classified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7a6703b-b8dc-4dc7-88db-06e908e2b37a/documents/c6e7b5a8-14fb-45d5-a72f-d88114579257_0f95edf2-7d25-4cbc-aaa9-d21cd8bb7b26.html,,,,,, Ethyl ethyl(phenyl)carbamate,1013-75-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7a6703b-b8dc-4dc7-88db-06e908e2b37a/documents/c6e7b5a8-14fb-45d5-a72f-d88114579257_0f95edf2-7d25-4cbc-aaa9-d21cd8bb7b26.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl methyl sulphide,624-89-5,"No repeated dose toxicity study is available on ethyl methyl sulphide.Groups of male and female rats were given doses of a structural analogue, dimethyl sulphide, in corn oil by gavage for 2 (5/sex/group), 6 (5/sex/group), or 14 (15/sex/group) weeks at doses of 0, 2.5, 25, or 250 mg/kg bw/day (Butterworth et al., 1975).No treatment-related effects were observed for body weights, food consumption, water consumption, hematology, and blood chemistry. Organ weights showed statistically significant increase in relative brain weight (to bodyweight) of female rats in the 250 mg/kg bw/day group at the 2-week interval. At 6 weeks, significant decreases in absolute, but not relative, heart weights were noted in these females. At 14 weeks, in male rats, absolute small intestine weights were significantly higher at all dose levels compared to the control group, and the relative small intestine weights were significantly increased at the highest two doses but not at the lowest dose. Females, dosed at 250 mg/kg bw/day, had statistically significant decreased absolute and relative thyroid weights (by 23 percent each). However, in males of this group, the relative thyroid weights were higher (by 19 percent). These organ weight changes could not be correlated with histopathological findings. Histopathological examination revealed some degree of fatty degeneration of the liver cells and some chronic inflammation of lungs and kidneys. The incidence and severity of these changes were comparable in treated and control animals. No abnormalities were seen in testes and ovaries. The NOAEL was higher than 250 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/508be1a0-2420-4d4f-b355-9a5140241618/documents/IUC5-a6b3066e-36a8-4405-98b7-67b9f174190b_d841b267-f8b1-48d9-ba9d-bfdccec2fa3b.html,,,,,, Ethyl methyl sulphide,624-89-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/508be1a0-2420-4d4f-b355-9a5140241618/documents/IUC5-a6b3066e-36a8-4405-98b7-67b9f174190b_d841b267-f8b1-48d9-ba9d-bfdccec2fa3b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Ethyl methyl sulphide,624-89-5," Oral route In an acute oral toxicity study (similar to OECD testing guideline 401 and according to GLP) (Douds, 1994a), groups of fasted, young adults Sprague-Dawley rats (5/sex) were given a single oral dose of undiluted methyl ethyl sulphide by gavage at dose of 5000 mg/kg bw (limit test) and observed for 14 days. One male rat died on day 1. All other animals survived up to the end of the study. Clinical signs were observed in all animals: salivation, piloerection, wobbly gait, decreased activity, lacrimation, eyelids partially closed, transient incidences of urine stain, transient incidences of rales, rough haircoat, decreased/no defecation, dark material around the facial area, low food consumption. Gross internal findings noted at necropsy for the animal that died included clear yellow-red fluid contents in the urinary bladder, light green staining of glandular mucosa in the stomach and greenish-red mucoid contents in the entire tract of the small intestine. No gross internal findings were observed at necropsy on study day 14 for the surviving animals. The Oral LD50(combined males/females) was > 5000 mg/kg bw. Dermal route The single-dose dermal toxicity of methyl ethyl sulphide was evaluated in Sprague-Dawley rats (similar to OECD test guideline 402 and according to GLP) (Douds, 1994b). A limit test was performed in which one group of 5 male and 5 female rats received a single dermal administration of the test article at the dose of 2000 mg/kg bw. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all limit test animals at the time of scheduled euthanasia (day 14). No mortality occurred during the limit test. The most notable clinical abnormalities observed during the study included dark material around the facial area, urine stain and dermal irritation at the site of the test application. Body weight gain was noted for the majority of animals during the test period. No significant gross internal findings were observed at necropsy on day 14. The acute dermal LD0 of methyl ethyl sulphide was estimated to be greater than 2000 mg/kg bw in the rat. Inhalation route In an acute inhalation toxicity study performed according to the OECD guideline # 403 and GLP, no mortality and clinical sign of toxicity was observed in male and female rats exposed to an atmosphere concentration of 21.72 mg/l (6988 ppm) of methyl ethyl sulphide for 4 hours. At necropsy, dark areas were observed on lungs of 1 female rat (Colin and Jackson, 1988). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/508be1a0-2420-4d4f-b355-9a5140241618/documents/IUC5-5e73003b-96e8-4df0-b822-11a197ab3527_d841b267-f8b1-48d9-ba9d-bfdccec2fa3b.html,,,,,, Ethyl methyl sulphide,624-89-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/508be1a0-2420-4d4f-b355-9a5140241618/documents/IUC5-5e73003b-96e8-4df0-b822-11a197ab3527_d841b267-f8b1-48d9-ba9d-bfdccec2fa3b.html,,oral,discriminating dose,"5,000 mg/kg bw",adverse effect observed, Ethyl methyl sulphide,624-89-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/508be1a0-2420-4d4f-b355-9a5140241618/documents/IUC5-5e73003b-96e8-4df0-b822-11a197ab3527_d841b267-f8b1-48d9-ba9d-bfdccec2fa3b.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Ethyl methyl sulphide,624-89-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/508be1a0-2420-4d4f-b355-9a5140241618/documents/IUC5-5e73003b-96e8-4df0-b822-11a197ab3527_d841b267-f8b1-48d9-ba9d-bfdccec2fa3b.html,,inhalation,discriminating conc.,"21,720 mg/m3",no adverse effect observed, "ethyl N,S-bis(4-oxo-4-(2,6,6-trimethylcyclohex-3-en-1-yl)butan-2-yl)cysteinate",2173997-41-4," The acute oral toxicity of Scentaurus Berry (GR-87 -0307) has been tested under the OECD guideline No. 423. It has been concluded that the median lethal dose of Scentaurus Berry after single oral administration to female rats is: LD50 (female rat): greater than 2000 mg/kg body weight According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dde13b58-49e3-4d39-8c3b-954738faf87d/documents/9fa8b8cf-d66a-4d50-a8b6-cd36ed85f57f_272ae56f-5b67-4ff9-b815-d77c9581f817.html,,,,,, "ethyl N,S-bis(4-oxo-4-(2,6,6-trimethylcyclohex-3-en-1-yl)butan-2-yl)cysteinate",2173997-41-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dde13b58-49e3-4d39-8c3b-954738faf87d/documents/9fa8b8cf-d66a-4d50-a8b6-cd36ed85f57f_272ae56f-5b67-4ff9-b815-d77c9581f817.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Ethyl N-hydroxyacetimidate,10576-12-2," Acute oral toxicity:  Acute oral toxicity dose (LD50) of Ethyl N-hydroxyacetimidate (10576-12-2) was predicted based on OECD QSAR toolbox 2901 mg/kg bw and different studies available on structurally similar read across substance Acetohydroxamic acid (546-88-3) 4800 mg/kg bw and closely related read across substance Ethyl vinyl ether (109-92-2) 8160 (7030 - 9480) mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Ethyl N-hydroxyacetimidate can be classified as category V of acute oral toxicity. Acute Inhalation toxicity:  Acute Inhalation toxicity dose (LC50) of Ethyl N-hydroxyacetimidate (10576-12-2) was predicted based on OECD QSAR toolbox 32.2 mg/L air (32200 mg/m3), and different studies available for closely related read across substance 2-methoxy-2-methylpropane (1634-04-4) 23576 ppm (23576000 mg/m3). All these studies concluded that the LC50 value is greater than 5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, Ethyl N-hydroxyacetimidate can be classified as category V of acute inhalation toxicity. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for Ethyl N-hydroxyacetimidate (10576-12-2) was predicted based on OECD QSAR toolbox 4125 mg/kg bwand differentstudies available on closely related read across substances Ethyl vinyl ether (109-92-2) >20000 mg/kg bw and Dibutyl ether (142-96-1) 10080 (4410–23040) mg/kg. All these studies concluded that the LD50 value is>2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Ethyl N-hydroxyacetimidate can be classified as category V of acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28cb0a68-52bc-414c-91b0-cbd48cb9a999/documents/d3803d51-c801-4a8b-9c4e-d9c1b163b449_c3d12ba0-7f68-4f1e-912d-5815d7b91458.html,,,,,, Ethyl N-hydroxyacetimidate,10576-12-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28cb0a68-52bc-414c-91b0-cbd48cb9a999/documents/d3803d51-c801-4a8b-9c4e-d9c1b163b449_c3d12ba0-7f68-4f1e-912d-5815d7b91458.html,,oral,LD50,"2,901 mg/kg bw",no adverse effect observed, Ethyl N-hydroxyacetimidate,10576-12-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28cb0a68-52bc-414c-91b0-cbd48cb9a999/documents/d3803d51-c801-4a8b-9c4e-d9c1b163b449_c3d12ba0-7f68-4f1e-912d-5815d7b91458.html,,dermal,LD50,"4,125 mg/kg bw",no adverse effect observed, Ethyl N-hydroxyacetimidate,10576-12-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28cb0a68-52bc-414c-91b0-cbd48cb9a999/documents/d3803d51-c801-4a8b-9c4e-d9c1b163b449_c3d12ba0-7f68-4f1e-912d-5815d7b91458.html,,inhalation,LC50,"32,200 mg/m3",no adverse effect observed, "Ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate",84434-11-7," The key studies were conducted to recognised testing guidelines, and with GLP certification. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fceedd2-97ba-4d63-ad2b-f7be9a6a56a8/documents/IUC5-f5d98382-817d-4242-95a8-0037b2be5488_aa41e181-0e48-4d76-a078-b70c2e20c42e.html,,,,,, "Ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate",84434-11-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fceedd2-97ba-4d63-ad2b-f7be9a6a56a8/documents/IUC5-f5d98382-817d-4242-95a8-0037b2be5488_aa41e181-0e48-4d76-a078-b70c2e20c42e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate",84434-11-7,"LD50 oral (rat) > 5000mg/kg (BASF 1982, OECD 401)LD50 dermal (rat) > 2000mg/kg (BASF 2013, OECD 402, GLP)IRT: saturated vapour does not cause mortality within 7hLD50 i.p. (rat) = 1470mg/kg (BASF 1982) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fceedd2-97ba-4d63-ad2b-f7be9a6a56a8/documents/IUC5-d9210616-363f-4226-bfac-bfd6334c5d56_aa41e181-0e48-4d76-a078-b70c2e20c42e.html,,,,,, "Ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate",84434-11-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fceedd2-97ba-4d63-ad2b-f7be9a6a56a8/documents/IUC5-d9210616-363f-4226-bfac-bfd6334c5d56_aa41e181-0e48-4d76-a078-b70c2e20c42e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Ethyl phenyl(2,4,6-trimethylbenzoyl)phosphinate",84434-11-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fceedd2-97ba-4d63-ad2b-f7be9a6a56a8/documents/IUC5-d9210616-363f-4226-bfac-bfd6334c5d56_aa41e181-0e48-4d76-a078-b70c2e20c42e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl piperidine-3-carboxylate,71962-74-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f6c42ef-3b29-4d5f-8843-209724db3c34/documents/ef556de2-10b5-46d3-a3cd-9d888a2a761e_160ba4ef-f4b8-4ae9-b97e-4c8929e9f645.html,,oral,LD50,"3,198.22 mg/kg bw",adverse effect observed, ethyl tetrahydrofuran-2-carboxylate,16874-34-3,Acute oral toxicity: data waiving ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d46e4c8a-4dd5-4395-aacb-8577480c6ef7/documents/IUC5-ad58e6c3-c62e-4ce2-b893-0418a22210c0_f4478e09-b1a7-4444-b322-f1c10ae4ff58.html,,,,,, "Ethyl trans-2,2,6-trimethylcyclohexanecarboxylate",22471-55-2," In a study conducted in accordance with OECD Guideline 407, oral administration of the test material, ET-344 SP, to rats for a period of twenty-eight consecutive days at dose levels of up to 1000 mg/kg/day resulted in toxicologically significant effects at 1000 and 150 mg/kg/day.The kidney changes detected in male rats from all treatment groups were consistent with well documented changes that are peculiar to the male rat in response to treatment with some hydrocarbons. This effect is, therefore, not indicative of a hazard to human health and for the purposes of hazard evaluation the ""No Observed Effect Level"" (NOEL) is considered to be 15 mg/ kg/ day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3e6a8d5-696f-46ed-a6eb-83ecdf378e81/documents/01129c4e-cfc3-4b0d-9398-1edcb3c6a517_f0904060-ff96-48fc-8e5b-d754308e3d44.html,,,,,, "Ethyl trans-2,2,6-trimethylcyclohexanecarboxylate",22471-55-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3e6a8d5-696f-46ed-a6eb-83ecdf378e81/documents/01129c4e-cfc3-4b0d-9398-1edcb3c6a517_f0904060-ff96-48fc-8e5b-d754308e3d44.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "Ethyl trans-2,2,6-trimethylcyclohexanecarboxylate",22471-55-2," A study was performed to assess the acute oral toxicity of the test material in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1987) No. 401 ""Acute Oral Toxicity "". There were no deaths. Common signs of systemic toxicity noted were ataxia, hunched posture and lethargy with additional signs of decreased respiratory rate. Animals recovered one day after dosing. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/ kg bodyweight. A study was performed to assess the acute dermal toxicity of the test material in the Sprague-Dawley strain rat. The method used followed that described in the OECD Guidelines for Testing of Chemicals (1981) No. 402 ""Acute Dermal Toxicity"". There were no deaths. No signs of systemic toxicity or skin irritation were noted during the study. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy. The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 2000 mg/ kg bodyweight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3e6a8d5-696f-46ed-a6eb-83ecdf378e81/documents/2930e18a-8831-4886-b20e-1522039755d4_f0904060-ff96-48fc-8e5b-d754308e3d44.html,,,,,, "Ethyl trans-2,2,6-trimethylcyclohexanecarboxylate",22471-55-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3e6a8d5-696f-46ed-a6eb-83ecdf378e81/documents/2930e18a-8831-4886-b20e-1522039755d4_f0904060-ff96-48fc-8e5b-d754308e3d44.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Ethyl trans-2,2,6-trimethylcyclohexanecarboxylate",22471-55-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3e6a8d5-696f-46ed-a6eb-83ecdf378e81/documents/2930e18a-8831-4886-b20e-1522039755d4_f0904060-ff96-48fc-8e5b-d754308e3d44.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl trichloroacetate,515-84-4,"A key study for acute oral toxicty according to toxic class method resulted in in LD >2000 mg/kg bw and did not show any clinical observations, body weight changes or gross pathological changes at limit dose. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8017a575-ad76-418a-9490-93969ddc2d14/documents/24288515-a3e9-448a-b9b2-e6e23fe12b45_babeafb3-6d95-42ad-bc62-047ab295491c.html,,,,,, Ethyl trichloroacetate,515-84-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8017a575-ad76-418a-9490-93969ddc2d14/documents/24288515-a3e9-448a-b9b2-e6e23fe12b45_babeafb3-6d95-42ad-bc62-047ab295491c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyl(2E)-3-[(tert-butoxycarbonyl)(propan-2-yl)amino]-2-(4-chlorophenyl)prop-2-enoate,1489004-24-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): LD50 > 2’000 mg/kg (oral, rat) (OECD No. 420 (Fixed Dose Method)) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3a83033-42bf-4611-ba31-b5f0af8b4245/documents/97500ca8-0ac8-4c01-a89d-c4cbc2fdfd5f_85a9ad15-4f63-46f0-bf7f-ac07ec4eab46.html,,,,,, Ethyl(2E)-3-[(tert-butoxycarbonyl)(propan-2-yl)amino]-2-(4-chlorophenyl)prop-2-enoate,1489004-24-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3a83033-42bf-4611-ba31-b5f0af8b4245/documents/97500ca8-0ac8-4c01-a89d-c4cbc2fdfd5f_85a9ad15-4f63-46f0-bf7f-ac07ec4eab46.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethylamine,75-04-7,"Inhalation: sub-chronic toxicity study (24 weeks), rat, no guideline followed, non-GLP, NOAEC systemic + local = 100 ppm = 184 mg/m3, K2 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9d02dab-09ff-42ea-bd3e-97d1c07fc81b/documents/IUC5-82ffecd6-d682-4e01-aebf-a78db15875b0_f1fc4e35-b4f7-4865-87b5-0d2558c96067.html,,,,,, Ethylamine,75-04-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9d02dab-09ff-42ea-bd3e-97d1c07fc81b/documents/IUC5-82ffecd6-d682-4e01-aebf-a78db15875b0_f1fc4e35-b4f7-4865-87b5-0d2558c96067.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,184 mg/m3,,rat Ethylamine,75-04-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9d02dab-09ff-42ea-bd3e-97d1c07fc81b/documents/IUC5-82ffecd6-d682-4e01-aebf-a78db15875b0_f1fc4e35-b4f7-4865-87b5-0d2558c96067.html,Repeated dose toxicity – local effects,inhalation,NOAEC,184 mg/m3,adverse effect observed,rat Ethylamine,75-04-7,"Acute oral toxicity test in rats: no guideline study (non-GLP), LD50 = 400 mg/kg bw, K2 Acute dermal toxicity test in rabbits: no guideline study (non-GLP), LD50 = 265 mg/kg bw, K2 Acute inhalation toxicity test in rats (gas): similar to OECD 403 (non-GLP), LC50 = 8.1 mg/l (4390 ppm), K2 Acute inhalation toxicity test in rats (vapour): similar to OECD 403 (non-GLP), 8000 ppm < LC50 < 16000 ppm, K2 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9d02dab-09ff-42ea-bd3e-97d1c07fc81b/documents/IUC5-9815af03-f134-4a5c-9f52-db62833d7fa8_f1fc4e35-b4f7-4865-87b5-0d2558c96067.html,,,,,, Ethylamine,75-04-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9d02dab-09ff-42ea-bd3e-97d1c07fc81b/documents/IUC5-9815af03-f134-4a5c-9f52-db62833d7fa8_f1fc4e35-b4f7-4865-87b5-0d2558c96067.html,,oral,LD50,400 mg/kg bw,adverse effect observed, Ethylamine,75-04-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9d02dab-09ff-42ea-bd3e-97d1c07fc81b/documents/IUC5-9815af03-f134-4a5c-9f52-db62833d7fa8_f1fc4e35-b4f7-4865-87b5-0d2558c96067.html,,dermal,LD50,265 mg/kg bw,adverse effect observed, Ethylamine,75-04-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9d02dab-09ff-42ea-bd3e-97d1c07fc81b/documents/IUC5-9815af03-f134-4a5c-9f52-db62833d7fa8_f1fc4e35-b4f7-4865-87b5-0d2558c96067.html,,inhalation,LC50,"4,390 ",adverse effect observed, Ethylbenzenesulphonic acid,57352-34-8," Prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound 2-ethylbenzenesulfonic acid (57352-34-8). The study assumed the use of male and female Crj: CD(SD)rats in chronic study of 90 days . No significant alterations were noted at the dose level of 722.722mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for 2-ethylbenzenesulfonic acid is considered to be 722.722mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d529e73-1836-4673-afc6-93372fae6edb/documents/04236b4f-ee6c-4d93-af1b-1b9e8163af7e_f5d9ee8f-0aea-463a-b535-be152ea60892.html,,,,,, Ethylbenzenesulphonic acid,57352-34-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d529e73-1836-4673-afc6-93372fae6edb/documents/04236b4f-ee6c-4d93-af1b-1b9e8163af7e_f5d9ee8f-0aea-463a-b535-be152ea60892.html,Chronic toxicity – systemic effects,oral,NOAEL,722.722 mg/kg bw/day,,rat Ethylbenzenesulphonic acid,57352-34-8," Acute oral toxicity:  Acute oral toxicity dose (LD50) for Ethylbenzenesulphonic acid (CAS no: 57352-34-8) was predicted based on OECD QSAR toolbox 3145 mg/kg bw; Danish (Q)SAR Database 4900 mg/kg bw and different studies available on structurally similar read across substances 2-Amino-5-methylbenzenesulfonic acid (88-44-8) and 4-aminobenzenesulphonic acid (CAS no: 121-57-3) 12300 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Ethylbenzenesulphonic acid can be classified as category V of acute oral toxicity. Acute Inhalation toxicity:  Acute Inhalation toxicity dose (LC50) of Ethylbenzenesulphonic acid (57352-34-8) was predicted based on OECD QSAR toolbox 652 mg/L air (652000 mg/m3), and different studies available for the structurally similar read across substances Sodium toluenesulphonate (12068-03-0) >557000 mg/m3 and Sodium cumenesulphonate (28348-53-0) >770000 mg/m3. All these studies concluded that the LC50 value is greater than 5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, Ethylbenzenesulphonic acid can be classified as category V of acute inhalation toxicity. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for Ethylbenzenesulphonic acid (57352-34-8) was predicted based on OECD QSAR toolbox 2143 mg/kg bwand differentstudies available on structurally similar read across substances Ethylbenzene (100-41-4) 15400 mg/kg bw and Sodium cumenesulphonate (28348-53-0) >2000 mg/kg bw. All these studies concluded that the LD50 value is>2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Ethylbenzenesulphonic acid can be classified as category V of acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d529e73-1836-4673-afc6-93372fae6edb/documents/b3f61572-b4da-4965-9db3-0955b733e24f_f5d9ee8f-0aea-463a-b535-be152ea60892.html,,,,,, Ethylbenzenesulphonic acid,57352-34-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d529e73-1836-4673-afc6-93372fae6edb/documents/b3f61572-b4da-4965-9db3-0955b733e24f_f5d9ee8f-0aea-463a-b535-be152ea60892.html,,oral,LD50,"3,145 mg/kg bw",no adverse effect observed, Ethylbenzenesulphonic acid,57352-34-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d529e73-1836-4673-afc6-93372fae6edb/documents/b3f61572-b4da-4965-9db3-0955b733e24f_f5d9ee8f-0aea-463a-b535-be152ea60892.html,,dermal,LD50,"2,143 mg/kg bw",no adverse effect observed, Ethylbenzenesulphonic acid,57352-34-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d529e73-1836-4673-afc6-93372fae6edb/documents/b3f61572-b4da-4965-9db3-0955b733e24f_f5d9ee8f-0aea-463a-b535-be152ea60892.html,,inhalation,LC50,"652,000 mg/m3",no adverse effect observed, Ethylcyclohexane,1678-91-7," The NOAEL of ethylcyclohexane administered by oral gavage to rats for 28 consecutive days was determined as 40 mg/kg bw based on effects on livers and kidneys, and in addition, mild effects on hematology and clinical chemistry. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/277c0c72-2a90-4c70-ba12-46a61193ffad/documents/d6db7b4a-5960-4fdf-a0aa-d6fbc045181d_40a5094d-9b5c-489a-9fdc-87048cd87f79.html,,,,,, Ethylcyclohexane,1678-91-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/277c0c72-2a90-4c70-ba12-46a61193ffad/documents/d6db7b4a-5960-4fdf-a0aa-d6fbc045181d_40a5094d-9b5c-489a-9fdc-87048cd87f79.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat Ethylcyclohexane,1678-91-7," Acute oral toxicity: An acute oral toxicity study was conducted in male and female rats administered a single limit dose of 2000 mg/kg of the test material by gavage. Discolored (light-brown) feces were noted from all animals on the day following dosing. No other abnormal clinical signs were observed during the 14-day observation period. No mortality was observed, and all animals gained weight normally. Treatment-related changes observed at necropsy were limited to minimal hyperkeratosis of the non-glandular gastric mucosa. for all males and three of five females. No other treatment-related changes or signs of organ toxicity were noted at necropsy. In the absence of significant gross organ lesions, other than the obvious signs of gastric irritation, no tissue was collected for histological examination. The acute oral LD50 for this test material was greater than 2000 mg/kg for male and female rats. Acute dermal toxicity: A limit dose of 2000 mg/kg was applied to the skin after the hair was removed with an electric clipper. An occlusive wrap was used to hold the test material against the skin for a period of 24 hours, and at the end of exposure, residual test material was washed off with running water. No treatment-related abnormal clinical signs were evident at any time during the 14-day observation period. On the last day of the observation period, a small wound with a scab was noted on the shoulder of a single male (Rat 745). Since this animal had appeared clinically normal from the day of dosing to Day 13, this wound was not considered related to administration of the test material. No treatment-related changes or signs of organ toxicity were evident at necropsy. In the absence of significant gross organ lesions, no tissue was collected for histological examination. Based on weight gain and survival rate, there was no evidence of percutaneous absorption. The acute dermal LD50 for this test material was greater than 2000 mg/kg for both sexes. Acute inhalation toxicity: Data from the read-across substance methylcyclohexane is available: Health Council of the Netherlands: When rats were exposed to vapour concentrations of 82,000-260,000 mg/m3 (ca. 20,000-62,000 ppm), mortality occurred within 13-70 minutes, animals showing anaesthesia, lethargy, ataxia, and terminal convulsion. Exposure to 11,000 mg/m3 (ca. 2600 ppm), for 6 hours, induced only minor symptoms (lethargy in 3 hours) CDC: In mice, a 2-hour LC50 of 41,500 mg/m3 (ca. 10,000 ppm) is reported. No detailed study description is given. Publication Treon: In this rabbit study, all the animals died at 59.9 mg/L within 70 min after exposure initiation. LC50 was considered as between 39.6 and 59.9 mg/L. Signs of toxicity at 59.9 mg/L (70 min exposure) included severe convulsions, rapid narcosis, labored breathing, salivation, and conjunctival congestion. Since it was judged in the SIDS INITIAL ASSESSMENT PROFILE for the Methyl-Ethylcyclohexane Category that the read across from methyl- to ethylcyclohexane is plausible and can be proven by the similarity in structure and physicochemical properties, it is assumed that ethylcyclohexane will behave in a similar manner with respect to acute inhalation toxicity. Based on the narcotic effects observed in the available studies for methylcyclohexane at high concentration classification of methylcyclohexane according to Regulation (EC) No 1272/2008 as STOT-SE 3 (narcotic effects) is fully justified. Therefore ethylcyclohexane will be classified as STOT-SE 3 (narcotic effects) too. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/277c0c72-2a90-4c70-ba12-46a61193ffad/documents/9665219d-5082-486b-b614-69ec35a9f426_40a5094d-9b5c-489a-9fdc-87048cd87f79.html,,,,,, Ethylcyclohexane,1678-91-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/277c0c72-2a90-4c70-ba12-46a61193ffad/documents/9665219d-5082-486b-b614-69ec35a9f426_40a5094d-9b5c-489a-9fdc-87048cd87f79.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethylcyclohexane,1678-91-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/277c0c72-2a90-4c70-ba12-46a61193ffad/documents/9665219d-5082-486b-b614-69ec35a9f426_40a5094d-9b5c-489a-9fdc-87048cd87f79.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethylcyclohexane,1678-91-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/277c0c72-2a90-4c70-ba12-46a61193ffad/documents/9665219d-5082-486b-b614-69ec35a9f426_40a5094d-9b5c-489a-9fdc-87048cd87f79.html,,inhalation,LC50,"39,600 mg/m3",adverse effect observed, Ethyldiisopropylamine,7087-68-5,"A 28 days inhalation study is available for EDIPA (Covance, 2021) Two additionnal supportive 28 days inhalation GLP and OECD 412 studies are available for the analogues DMIPA and DMEA. In these three 28 days inhalation studies, the lead effect was local toxicity with no specific systemic toxicity as indicated in the robust study summaries. No 90 days inhalation toxicity study is available for EDIPA, however a 90 days toxicity by inhlation study is available for DMEA (Beebe, 2021). This study is used as read across to fulfill the 90 subchronic endpoint (see read across justification document). A two weeks by oral route was performed with EDIPA as preliminary study to OECD 414 in rats. 1) 7-Days inhalation study EDIPA(Rogers, 2021): The test item, N,N-Diisopropylethylamine (EDIPA), was administered by nose-only inhalation administration to Wistar Han rats, for up to 6 hours a day, for up to 5 days a week, for 1 week at achieved exposure levels of 9.78, 49.7, 100, 156 or 231 ppm resulted in test item-related deaths at 156 or 231 ppm, which resulted in cessation of exposures at these levels after four days or one day respectively, however, exposure to EDIPA was generally well tolerated at the lower exposure levels, 100 ppm or below.  Histopathological changes related to treatment with EDIPA were seen in the nose (inflammation, vacuolation/degeneration of the olfactory, respiratory and glandular epithelium and ulceration of the respiratory epithelium), larynx (inflammation, vacuolation/degeneration of the respiratory and glandular epithelium, and ulceration of the respiratory epithelium) and trachea (inflammation and vacuolation/degeneration of the respiratory epithelium) in decedents exposed to 156 or 231 ppm. In animals killed after 7 days (9.78, 49.7 or 100ppm), 4 days (156 ppm) or 1 day (231 ppm) of treatment, changes were seen in the nose (inflammation and vacuolation/degeneration of the olfactory epithelium) in animals exposed to 100, 156 or 231 ppm, and in the trachea in (vacuolation/degeneration of the respiratory epithelium) in animals exposed to 231 ppm.All these changes were more focal and less severe than in decedent animals.   Exposure to EDIPA at 156 or 231 ppm resulted in marked clinical signs in the majority of the animals and contributed to the deterioration in the clinical condition of some individuals which necessitated early termination, it is therefore considered these exposure levels are unsuitable for selection for the following 4-week inhalation study with EDIPA.  Body weight loss in males and reduced body weight gain in females exposed to 100 ppm during the treatment period together with the degenerative histopathological changes in the nose seen at this exposure level also precludes its selection for use in the 4-week inhalation study with EDIPA.   Based on the results of this study exposure levels below 100 ppm should be considered for selection in the 4-week inhalation study with EDIPA. 2) 28 days inhalation study EDIPA (Rogers, 2021): The test item N,N-Diisopropylethylamine (EDIPA) was administered by snout-only inhalation administration to Wistar Han rats, for 6 hours a day, 5 days a week, for 4 weeks at achieved exposure levels of 10.8, 37.3 and 77.8 ppm and was clinically well tolerated, recovery was assessed during a 4 week off-dose period. There were no test item-related decedents on the study with minimal effects on clinical signs, body weight, and organ weights with recovery seen after 4 weeks without exposure. No effects were seen on food consumption, ophthalmoscopy, hematology and blood chemistry, bronchoalveolar lavage, sperm analysis or macroscopic pathology and the variations seen in the estrous cycles were questionable due to the lack of relevant historical control data, and the absence of correlation with any relevant changes in organ weights or microscopic findings in the ovaries and uterus as well as comparable estrous profiles observed between treated groups and controls at the end of recovery period. Test-item related changes were evident in the nasal turbinates of animals exposed to 37.3 or 77.8 ppm and consisted of minimal to slight vacuolation/atrophy of the respiratory epithelium. Minimal to slight vacuolation/atrophy of the olfactory epithelium was also seen in the majority of animals exposed to 77.8 ppm. There was full recovery after 4 weeks without exposure to EDIPA in the respiratory epithelium and near complete recovery in the olfactory epithelium and therefore these findings were considered to be non-adverse. The No Observed Adverse Effect Concentration for systemic and local toxicity is considered to be 77.8 ppm based on the non-adverse histopathology findings in the nasal turbinates showing recovery after 4 weeks without exposure and the effects seen on clinical signs, body weight or organ weights which recovered at the end. 3) 90-day toxicity study by inhalation with analogue DMEA (Beebe, 2021) Four main groups of 10 male and 10 female Wistar Han rats each were exposed (nose-only) to target concentrations of 0 (control), 10, 30 or 100 ppm for 6 hours/day, 5 days/week over a 13-week period according to OECD 413 guideline and GLP. Animals of the main groups were sacrificed on the day after the last exposure. In addition, two recovery groups, also consisting of 10 male and 10 female animals each, were simultaneously exposed with the main study animals to the control or 100 ppm test atmosphere, and were sacrificed after a 6-week recovery period following the last exposure.Animals received the air control, or the test item, Dimethylethylamine by inhalation for 13 weeks. Recovery animals were similarly treated for 13 weeks followed by a 6 week off dose period. During the study, clinical condition, detailed physical and arena observations, sensory reactivity, grip strength, motor activity, estrous cycle, body weight, food consumption, ophthalmoscopy, hematology (peripheral blood), blood chemistry, thyroid hormone (T3 and T4), thyroid hormone (TSH), organ weight, sperm analysis, bronchoalveolar lavage, macropathology and histopathology investigations were undertaken. The mean achieved atmosphere concentrations were 10.3, 29.9 and 106 ppm (103, 100 and 106% of target) for Groups 2, 3 and 4, respectively and was clinically well tolerated, recovery was assessed during a 6 week off-dose period.  There were no test item-related deaths or effects on clinical signs, food consumption, sensory reactivity and grip strength or motor activity.  There were also no effects on ophthalmoscopy, haematology, blood chemistry, thyroid hormone levels, sperm motility, estrous cycle, bronchoalveolar lavage, organ weights or macroscopic pathology. Test item-related changes were evident in the nasal turbinates of animals exposed to 29.9 or 106 ppm and consisted of minimal to moderate degeneration/atrophy of the olfactory epithelium mainly affecting the dorsal parts of the nasal vestibules and was associated with loss of axon bundles in the sub adjacent lamina propria.  There was evidence of partial recovery after 6 weeks without exposure to DMEA; however, based on the incidence and severity these findings were considered adverse. Reduced body weight gain evident at the end of the treatment period for both sexes exposed to 106 ppm resolved following 6 weeks of recovery.  Based on the findings in this study a No Observed Adverse Effects Concentration (NOAEC) for the local toxicity is considered to be 10.3 ppm based on the minimal to moderate nasal degeneration/atrophy of the olfactory epithelium recorded at 29.9 or 106 ppm and the NOAEC for systemic toxicity is considered to be 106 ppm.   Two weeks oral toxicity study with EDIPA (Covance, 2021) A two weeks oral stuy was performed with EDIPA as a preliminary study to set the dose-levels for the range finding embryofetal developmental study in rats by oral route. The purpose of this study was to assess the systemic toxic potential of Ethyldiisopropylamine, in a 14 day oral gavage study in Crl:CD(SD) rats and to aid in the selection of suitable dose levels for future repeat dose reprotoxicity studies by oral route. Three groups, each comprising two female Crl:CD(SD) rats, received Ethyldiisopropylamine at doses of 25, 75 or 150 mg/kg/day. A similarly constituted control group received the vehicle, 1% w/v methylcellulose plus 0.1% Tween 80, at the same volume dose as control groups. During the study clinical condition, body weight, food consumption and macropathology investigations were undertaken. Results From Day 1 to 3 of study, females that received 150 mg/kg/day showed signs comprised of elevated gait, decreased activity, piloerection, closed and/or partially closed eyelids, hunched posture and chromodacryorrhea. Subsequently, this group was entirely prematurely killed on the grounds of animal welfare on Day 3 of study. Macroscopic examination of these females revealed no abnormalities. Females that received 75 mg/kg/day showed signs of a lesser severity and comprised partially closed eyelids from Day 1 to 13 of treatment and for 1 female, unsteady gait on Day 1 of treatment only. There were no signs recorded for females receiving 25 mg/kg/day. Body weight gain from Day 1 to 15 of study was not clearly affected by treatment at 25 or 75 mg/kg/day. There was a suggestion of slightly reduced food intake from Day 1 to 3 of treatment for females that received 75 mg/kg/day. Food intake was not clearly affected by treatment for females that received 25 mg/kg/day. There were no macroscopic findings after 14 days of treatment for females that received 25 or 75 mg/kg/day. Considering the adverse clinical signs observed at 150 mg/kg/day and clinical signs observed at 75 mg/kg/day, it was concluded that the selection of 100 mg/kg/day is a suitable high dose for a subsequent preliminary study for effects on embryo-fetal development (Covance Study No. 8434891). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc305904-6de4-40b4-bb31-4d6ed64e68ad/documents/IUC5-805ed26c-7f93-405d-9c2c-9944f552a498_3eec4720-325a-4fe4-b382-45ac8e0abefb.html,,,,,, Ethyldiisopropylamine,7087-68-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc305904-6de4-40b4-bb31-4d6ed64e68ad/documents/IUC5-805ed26c-7f93-405d-9c2c-9944f552a498_3eec4720-325a-4fe4-b382-45ac8e0abefb.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,75 mg/kg bw/day,,rat Ethyldiisopropylamine,7087-68-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc305904-6de4-40b4-bb31-4d6ed64e68ad/documents/IUC5-805ed26c-7f93-405d-9c2c-9944f552a498_3eec4720-325a-4fe4-b382-45ac8e0abefb.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,318 mg/m3,,rat Ethyldiisopropylamine,7087-68-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc305904-6de4-40b4-bb31-4d6ed64e68ad/documents/IUC5-805ed26c-7f93-405d-9c2c-9944f552a498_3eec4720-325a-4fe4-b382-45ac8e0abefb.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat Ethyldiisopropylamine,7087-68-5,"Single exposure (acute) studies indicate that EDIPA is harmful if swallowed (rat LD50 = 317), of low toxicity if absorbed through skin (rat LD0 > 2000 mg/kg), and toxic if inhaled (rat 4-hr LC50 = 2.63 mg/l) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc305904-6de4-40b4-bb31-4d6ed64e68ad/documents/IUC5-0f66ca44-81e2-4204-a149-30279c10a956_3eec4720-325a-4fe4-b382-45ac8e0abefb.html,,,,,, Ethyldiisopropylamine,7087-68-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc305904-6de4-40b4-bb31-4d6ed64e68ad/documents/IUC5-0f66ca44-81e2-4204-a149-30279c10a956_3eec4720-325a-4fe4-b382-45ac8e0abefb.html,,oral,LD50,317 mg/kg bw,adverse effect observed, Ethyldiisopropylamine,7087-68-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc305904-6de4-40b4-bb31-4d6ed64e68ad/documents/IUC5-0f66ca44-81e2-4204-a149-30279c10a956_3eec4720-325a-4fe4-b382-45ac8e0abefb.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Ethyldiisopropylamine,7087-68-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc305904-6de4-40b4-bb31-4d6ed64e68ad/documents/IUC5-0f66ca44-81e2-4204-a149-30279c10a956_3eec4720-325a-4fe4-b382-45ac8e0abefb.html,,inhalation,LC50,"2,630 mg/m3",adverse effect observed, Ethyldimethylamine,598-56-1,"There are three studies available for DMEA. A 7-, 28- and 90-day inhalation studies performed in rats performed. A two weeks oral toxicity repeated study was performed as a preliminary study for oral reprotoxicity studies (Renaud, Covance 2020).   1. 7-day inhalation toxicity study (van Triel et al., 2019) The concentrations to be tested in the sub-acute study were selected on the basis of a 7-day range finding study in which five groups of five male and five female Wistar rats were exposed to target concentrations of 0, 10, 100, 500 or 1000 ppm for 6 hours/day, 5 days/week. Exposure at 1000 ppm resulted in marked toxicity, as evidenced by clinically observed breathing abnormalities and general signs of substantial distress, depressed growth and food intake, increased relative weight of several organs (heart, lungs, and in males also testes and adrenals), and histopathological changes along the entire respiratory tract indicating severe epithelial damage (e.g. ulceration, atrophy, necrosis) in the upper airways and primarily inflammatory changes in the lower airways. Exposure at 500 ppm resulted in transient clinical abnormalities, growth depression (mainly in males), atrophy of the nasal olfactory epithelium, and inflammatory changes in the lower airways of several animals. Minimal to mild atrophy of the olfactory epithelium was still observed in animals exposed at 100 ppm. Exposure at 10 ppm did not result in any exposure-related changes.   2. 28-day inhalation toxicity study (Van Triel et al., 2019) The toxicity of Dimethylethylamine upon repeated exposure by inhalation was investigated in a sub-acute (28-day) study in Wistar rats perfomed according to OECD 412 guideline and GLP. Four main groups of five male and five female rats each were exposed (nose-only) to target concentrations of 0 (control), 10, 50 or 250 ppm for 6 hours/day, 5 days/week over a 28-day period. Animals of the main groups were sacrificed on the day after the last exposure. In addition, two recovery groups, also consisting of five male and five female animals each, were simultaneously exposed with the main study animals to the control or 250 ppm test atmosphere, and were sacrificed after a 28-day recovery period following the last exposure. Endpoints to assess toxicity included clinical and ophthalmoscopic observations, growth, food consumption, hematology, clinical chemistry and organ weights. Estrus cyclicity was evaluated during the last three weeks of the exposure period, and sperm analysis was conducted at sacrifice. In addition, the animals were macroscopically examined at necropsy, the right lung lobes were lavaged and used for determination of biochemical markers and cell differentials, and the left lung lobes together with the full respiratory tract and a number of organs and tissues were examined microscopically. The target concentrations of Dimethylethylamine were accurately achieved as demonstrated by the results of total carbon analysis of the test atmosphere. The overall average (± standard deviation) actual concentrations were 10.0 (± 0.2), 49.7 (± 0.8) or 249.0 (± 4.0) ppm for the low-, mid- and high-concentration groups, respectively. Mortality did not occur during the study. Clinical and ophthalmoscopic observations revealed no exposure-related abnormalities. Body weight data showed a statistically significantly reduced growth in male animals of the high concentration group throughout the exposure period; average body weight was about 10% below controls at the end of the exposure period. Catch-up growth was observed during the 28- day recovery period. Body weight gain of males of the mid-, and females of the high concentration group was also below control level (-28%) during the first ~2 weeks of the exposure phase (though statistical significance was not reached). Food consumption was slightly lower than controls in males of the high-concentration group throughout the exposure period (maximally approximately 15%) followed by normal food intake during the recovery period and in females of the high-concentration group during the first two weeks of the study (maximally approximately 10%). Estrus cycle evaluation did not reveal any exposure-related abnormalities. No exposure-related changes were observed on epidydimal and testicular sperm analysis. Analysis of hematology parameters showed a decrease in absolute number of eosinophils in blood of males of the high-concentration group sacrificed at the end of the exposure period. This finding was not accompanied by any changes in other white blood cell parameters, by any changes in females, or in males of the recovery groups. No exposure-related changes were observed in red blood cell and coagulation parameters. Investigation of clinical chemistry parameters at the end of the exposure period revealed a statistically significant increase in plasma thyroxine (T4) concentration in females of the high concentration group when compared to concurrent controls (but which was within the historical control range, and in line with results obtained in control animals of the recovery group. Therefore, is was not considered as treatment-related). No further changes in clinical chemistry parameters were observed in animals of the main and recovery groups. Analysis of cellular parameters in bronchoalveolar lavage (BAL) fluid did not reveal any adverse changes in response to the exposure to the test material. An increase in the absolute number of macrophages in BAL fluid of males of the high-concentration group was considered to be of no toxicological significance, because changes in the percentage distribution of white blood cells in BAL fluid (which normally contains ~100% macrophages in healthy animals) or any histopathological changes in the lungs were absent. Investigation of biochemical parameters revealed a slight, but statistically significant increase in gamma-glutamyltransferase (GGT) activity in BAL fluid of females of the mid- and high-concentration main groups, which was fully reversible within the 28-day recovery period. Organ weight data obtained at necropsy of animals of the main groups showed an increase in relative (to body weight) weight of the testes (+15%) and adrenals (+28%) in males of the high-concentration, and a decreased weight of the thymus in males (-28%) and females (-27%) of the high-concentration group. At the end of the recovery period, no exposure-related changes were observed in the weight of selected organs (seminal vesicles, testes, epididymides, and thymus). Macroscopic examination at scheduled termination revealed no exposure-related gross pathology. Microscopic examination revealed exposure-related histopathological changes in the nasal tissues of animals of the mid- and high-concentration group, characterized by degeneration of the respiratory and olfactory epithelium. The incidence and severity of these lesions were evidently concentration-dependent. In the mid-concentration group, animals displayed minimal to mild degeneration of the respiratory epithelium (in 4/10 animals at level 2 of the nose), and minimal to mild degeneration of the olfactory epithelium at levels 3 (10/10 animals), 4 (9/10 animals) and 5 (2/10 animals) of the nose2. In the high-concentration group, minimal to mild degeneration of the respiratory epithelium was observed in all animals at level 2, and mild to moderated degeneration of the olfactory epithelium was found in all animals throughout levels 3 to 6 of the nasal tissues. At the end of the 28-day recovery period, minimal to mild degeneration of the olfactory epithelium was observed at level 3 in 7/10 animals and at level 4 in only one animal of the high-concentration group (changes in the respiratory epithelium were no longer found), indicating substantial - but not full - recovery of the nasal pathology. No exposure-related microscopic changes were observed in the lower respiratory tract or in any of the other organs and tissues examined. Under the conditions of the current study, sub-acute inhalation exposure to Dimethylethylamine at actual concentrations of: • 249.0 ppm resulted in local toxicity in the upper respiratory tract as characterized by degeneration of the respiratory and olfactory epithelium in the nasal tissues and systemic toxicity, as evidenced by significant decrease in body weight and food consumption; • 49.7 ppm resulted in no systemic toxicity but presence of adverse local changes in the upper respiratory tract, as characterized by degeneration of the respiratory and olfactory epithelium in the nasal tissues; • Both in the 49.7 and 249.0 ppm groups, substantial, but not full recovery of the nasal pathology was observed within a 4-week post-exposure recovery period; • 10 ppm resulted in no systemic or local adverse changes. Based on these findings, the No-Observed-Adverse-Effect-Concentration (NOAEC) for systemic toxicity upon sub-acute inhalation exposure to Dimethylethylamine in rats was placed at 49.7 ppm, and the NOAEC for local toxicity was placed at 10.0 ppm.   3. 90-day toxicity study by inhalation (Beebe, 2021) Four main groups of 10 male and 10 female Wistar Han rats each were exposed (nose-only) to target concentrations of 0 (control), 10, 30 or 100 ppm for 6 hours/day, 5 days/week over a 13-week period according to OECD 413 guideline and GLP. Animals of the main groups were sacrificed on the day after the last exposure. In addition, two recovery groups, also consisting of 10 male and 10 female animals each, were simultaneously exposed with the main study animals to the control or 100 ppm test atmosphere, and were sacrificed after a 6-week recovery period following the last exposure.Animals received the air control, or the test item, Dimethylethylamine by inhalation for 13 weeks. Recovery animals were similarly treated for 13 weeks followed by a 6 week off dose period. During the study, clinical condition, detailed physical and arena observations, sensory reactivity, grip strength, motor activity, estrous cycle, body weight, food consumption, ophthalmoscopy, hematology (peripheral blood), blood chemistry, thyroid hormone (T3 and T4), thyroid hormone (TSH), organ weight, sperm analysis, bronchoalveolar lavage, macropathology and histopathology investigations were undertaken. The mean achieved atmosphere concentrations were 10.3, 29.9 and 106 ppm (103, 100 and 106% of target) for Groups 2, 3 and 4, respectively and was clinically well tolerated, recovery was assessed during a 6 week off-dose period.  There were no test item-related deaths or effects on clinical signs, food consumption, sensory reactivity and grip strength or motor activity.  There were also no effects on ophthalmoscopy, haematology, blood chemistry, thyroid hormone levels, sperm motility, estrous cycle, bronchoalveolar lavage, organ weights or macroscopic pathology. Test item-related changes were evident in the nasal turbinates of animals exposed to 29.9 or 106 ppm and consisted of minimal to moderate degeneration/atrophy of the olfactory epithelium mainly affecting the dorsal parts of the nasal vestibules and was associated with loss of axon bundles in the sub adjacent lamina propria.  There was evidence of partial recovery after 6 weeks without exposure to DMEA; however, based on the incidence and severity these findings were considered adverse. Reduced body weight gain evident at the end of the treatment period for both sexes exposed to 106 ppm resolved following 6 weeks of recovery.  Based on the findings in this study a No Observed Adverse Effects Concentration (NOAEC) for the local toxicity is considered to be 10.3 ppm based on the minimal to moderate nasal degeneration/atrophy of the olfactory epithelium recorded at 29.9 or 106 ppm and the NOAEC for systemic toxicity is considered to be 106 ppm.     ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a3d0612-8e89-4344-a884-89c1a760585f/documents/IUC5-60f66fa5-0441-417a-a17e-2f695ca04e57_61ad2500-a044-4137-94c3-8b6c7cc98e5c.html,,,,,, Ethyldimethylamine,598-56-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a3d0612-8e89-4344-a884-89c1a760585f/documents/IUC5-60f66fa5-0441-417a-a17e-2f695ca04e57_61ad2500-a044-4137-94c3-8b6c7cc98e5c.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,318 mg/m3,,rat Ethyldimethylamine,598-56-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a3d0612-8e89-4344-a884-89c1a760585f/documents/IUC5-60f66fa5-0441-417a-a17e-2f695ca04e57_61ad2500-a044-4137-94c3-8b6c7cc98e5c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,adverse effect observed,rat Ethyldimethylamine,598-56-1," In rats, the oral DL50 is 594 mg/kg, the 1-hour LC50 is between 2.3 and 15.4 mg/l air and the dermal LD0 is higher than 2000 mg/kg. Oral route The Acute oral toxicity of Dimethylethylamine (DMEA) was evaluated in rats according to a protocol similar to the OECD N°401 guideline (Acute Toxic Standard Method) (BASF AG, 1973). Groups of 5 male and 5 female Sprague Dawley rats were given a single oral dose of DMEA at doses of 136, 272, 544, 680, 850, 1088 mg/kg. Following treatment, rats were observed daily and weighted weekly. A gross necropsy examination was performed at the time of scheduled euthanasia (Day 7). 10/10 animals died on day 1 after administration of 1088 mg/kg (5 males and 5 females). Animals showed congestive hyperemia, acute dilatation of the heart, dilatation of the stomach, gastritis and diffuse reddening of the stomach. 9/10 animals died on day 1 after administration of 850 mg/kg (4 males and 5 females). The last male that survived died on day 2. Animals showed adhesion on the stomach, thickened forestomach and irregular folding at fundus. 8/10 animals died on day 1 after administration of 680 mg/kg (4 males and 4 females). One additional female died on day 2. 1/10 animal died on day 1 after administration of 544 mg/kg (1 male). No death was recorded at doses of 272 and 136 mg/kg. Symptoms observed included accelerated respiration, abdominal position, squatting posture, apathy, atony, dyspnoea, tremor, nose and eye discharge. Between days 1 and 6 all symptoms reversed in surviving animals. The oral LD50 of DMEA is 594 mg/kg (540-650 mg/kg) in Sprague Dawley rats with 95% confidence interval limits. The Acute oral toxicity of Dimethylethylamine (DMEA) was evaluated in male and female mice (Truhaut, 1976). Groups of 10 Swiss mice were administered orally DMEA solution at 170, 340, 510, 680, 850, 1190 and 1700mg/kg and animals were observed during 7days. After administration, mice died within 24hours. No mortality was observed after Day2. Under these experimental conditions, the oral LD50 of DMEA is 650+/-50 mg/kg in male mice and 600+/-50 mg/kg in female mice. Inhalation The acute inhalation toxicity of Dimethylethylamine (DMEA) was evaluated in a 1-hour, single-exposure study in rats (BASF AG, 1980). DMEA was initially administered to a single group of 10 male and 10 female Sprague Dawley rats via whole-body vapor exposure at concentrations between 2.3 and 15.4 mg/l. Mortality and clinical signs were evaluated daily over a 14-day observation period. Animals were weighted on days 0, 7 and 14.Mortality was 0/20 at 2.3mg/l and 18/20 (10 males and 8 females) at 15.4 mg/l. All death occurred during exposure.During the 1-hour exposure, animals exposed to 2.3 mg/l air showed a slight increased salivation. Animals exposed to 15.4 mg/l air showed a decreased respiratory rate, gasping, slight apathy, eyelid closure, increased salivation, nasal secretion; furthermore, decreased response to touch, decreased reflex reactions (pain and auricle reflex), overall a poor general state was observed. In female rats trembling of the whole body and hunched posture were observed. During observation period, 1 male exposed to 2.3 mg/l air showed alopecia after 13 days of observation. After exposure to 15.4 mg/L air, surviving animals displayed gasping, slight apathy, lid closure, slight increased salivation, reduced pain reflex, tremor and twitching, piloerection. After 6 days they were without symptoms. 11 out of 18 dying animals showed diffuse alveolar emphysema; 1 animal presented atelectasis. At necropsy, in the low dose group 9/20 animals showed a grey-red discoloration of the lung and sporadic paetechia were seen. Based on the results of this study, the LC50 for 1-hour exposure to DMEA was between 2.3 and 15.4 mg/l air. Dermal route The Acute dermal toxicity of Dimethylethylamine (DMEA) was evaluated in male and female Sprague Dawley rats according to OECD N°402 guideline (Clouzeau, 1993). Ten rats were applied dermally 2000 mg/kg for 24 hours and then observed during 14days. No control group was used. Neither death nor clinical signs were recorded during the study showing that under these experimental conditions, the dermal LD0 of DMEA is higher than 2000 mg/kg in rats. The acute dermal toxicity of Dimethylethylamine (DMEA) was also evaluated in rabbits (BASF AG, 1979). DMEA was applied unchanged in a dose of 200 mg/kg for 24 hours to the clipped skin of the back and flank (area about 50 cm2) of groups of 5 male and 5 female Vienna rabbits at doses of 200 mg/kg in a semi-occlusive dressing for 24 hours.  Following treatment, rabbits were observed daily and a gross necropsy examination was performed at the time of scheduled euthanasia (Day 8). None of the tested 5 male or 5 female rabbits died within the observation period of 8 days. No abnormality was observed at necropsy. Under these experimental conditions, the dermal LD0 of DMEA is higher than 200 mg/kg in Vienna rabbits. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a3d0612-8e89-4344-a884-89c1a760585f/documents/IUC5-26285272-b0d3-4373-9f74-cdbd7b1c106b_61ad2500-a044-4137-94c3-8b6c7cc98e5c.html,,,,,, Ethyldimethylamine,598-56-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a3d0612-8e89-4344-a884-89c1a760585f/documents/IUC5-26285272-b0d3-4373-9f74-cdbd7b1c106b_61ad2500-a044-4137-94c3-8b6c7cc98e5c.html,,oral,LD50,594 mg/kg bw,adverse effect observed, Ethyldimethylamine,598-56-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a3d0612-8e89-4344-a884-89c1a760585f/documents/IUC5-26285272-b0d3-4373-9f74-cdbd7b1c106b_61ad2500-a044-4137-94c3-8b6c7cc98e5c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Ethyldimethylamine,598-56-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a3d0612-8e89-4344-a884-89c1a760585f/documents/IUC5-26285272-b0d3-4373-9f74-cdbd7b1c106b_61ad2500-a044-4137-94c3-8b6c7cc98e5c.html,,inhalation,LC50,"2,300 mg/m3",adverse effect observed, Ethylene,74-85-1,"In accordance with Section 2 of REACH Annex XI, studies via the oral and dermal routes are not technically feasible as the substance is a gas at room temperature. The NOAEC for systemic inhalation toxicity in rats is 10,000 ppm (11,473 mg/m3) and the LOEC for local effects (mild rhinitis) is 10 ppm (11.47 mg/m3). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78f20f93-2373-4e3d-8b90-9f02c094ae36/documents/IUC5-893099d2-0626-4b3f-97f0-32eaef495b60_1de9f63b-525b-4183-a3eb-06554ce11df3.html,,,,,, Ethylene,74-85-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78f20f93-2373-4e3d-8b90-9f02c094ae36/documents/IUC5-893099d2-0626-4b3f-97f0-32eaef495b60_1de9f63b-525b-4183-a3eb-06554ce11df3.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"11,473 mg/m3",,rat Ethylene,74-85-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78f20f93-2373-4e3d-8b90-9f02c094ae36/documents/IUC5-893099d2-0626-4b3f-97f0-32eaef495b60_1de9f63b-525b-4183-a3eb-06554ce11df3.html,Repeated dose toxicity – local effects,inhalation,LOAEC,11.47 mg/m3,adverse effect observed,rat Ethylene,74-85-1,"Ethylene has low acute inhalation toxicity, the LC50 in rats is > 57,000 ppm (equivalent to >65,400 mg/m3). Anaesthesia in humans is seen at concentrations of 80% ethylene (800,000 ppm or 917,000 mg/m3). In accordance with Section 2 of REACH Annex XI, studies via the oral and dermal route do not need to be conducted as the substance is a gas at room temperature. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78f20f93-2373-4e3d-8b90-9f02c094ae36/documents/IUC5-6d129ccc-5558-4ffa-bc24-f2db38e977a8_1de9f63b-525b-4183-a3eb-06554ce11df3.html,,,,,, Ethylene bis(3-mercaptopropionate),22504-50-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1b1cd76-b54e-48e3-ba18-cf8c2c62ea1c/documents/7de4cbdd-1d8a-474e-8add-e96c7bcf4e00_f459f904-8e58-46d4-bc50-72b1f5f26314.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,24 mg/kg bw/day,,rat Ethylene bis(3-mercaptopropionate),22504-50-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): not required since data on two other routes of exposure are available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1b1cd76-b54e-48e3-ba18-cf8c2c62ea1c/documents/3eafb3ce-939f-46c9-93bc-c1380c7a3920_f459f904-8e58-46d4-bc50-72b1f5f26314.html,,,,,, Ethylene bis(3-mercaptopropionate),22504-50-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1b1cd76-b54e-48e3-ba18-cf8c2c62ea1c/documents/3eafb3ce-939f-46c9-93bc-c1380c7a3920_f459f904-8e58-46d4-bc50-72b1f5f26314.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Ethylene bis(3-mercaptopropionate),22504-50-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1b1cd76-b54e-48e3-ba18-cf8c2c62ea1c/documents/3eafb3ce-939f-46c9-93bc-c1380c7a3920_f459f904-8e58-46d4-bc50-72b1f5f26314.html,,inhalation,LC50,"> 1,640 mg/m3",no adverse effect observed, "Ethylene bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]",32509-66-3," With reference to the effects observed in several repeated dose studies (low body weight and body weight gain, increased bilirubin level, histopathological changes in adrenals and liver) a 14 day short term oral toxicity study with special focus on the reported effects was performed in rats (non-pregnant and pregnant). This study followed in principle the design as lined out in OECD 407. The test item, Hostanox O 3 P, was administered to Wistar rats orally (by gavage) at the doses of 100 (low dose), 300 (mid dose) and 600 mg/kg/day (to 3 cohorts of rats: the repeated dose phase (14 days), the satellite group (3 and 10 days treatment) and the Embryo Fetal Developmental phase (gestation day 5 to 19 treatment). The repeated dose phase and the satellite group consisted of 6 rats/sex/group, while the Embryo Fetal Developmental phase consisted of 6 presumed pregnant rats (gestation day 0). In this study, assessments included clinical signs, body weights, food consumption, clinical laboratory investigations of blood (for hematology, acute phase proteins, clinical chemistry and hormone analysis), gross pathology, and histopathological evaluation (repeat dose phase and satellite group). The microscopic examination was initially performed for the control and high dose groups of males and females, and extended to the following organs of lower dose groups as higher incidence of lesions was present in high dose groups The following observations were reported: 1.     Immunological response - increased number of neutrophils, leukocytes and monocytes from day 10 on at 300 and 600 mg/kg bw/d (highest dose tested) - increase in inflammatory markers at day 10-group in all animals at doses ≥ 300 mg/kg bw/d, at day 14-group at 600 mg/kg bw/d dose group and for the developmental phase rats (Gestation Day 20) at all dose groups. - histopathological changes of thymus and spleen at 600 mg/kg bw/d and - lymphangiectasis in the gastro intestinal tract from day 3 onwards ≥ 300 mg/kg bw/d 2.     Adrenals Histopathological changes were reported from day 3 onwards. However, it has to be emphasized that the hormonal status remains unchanged and comparable to that of the control animals. Therefore, an endocrine activity is excluded. 3.     Liver: - the bilirubin concentration in blood is increased at 300 and 600 mg/kg bw/d. - furthermore, the AST and ALT level as well as the triglyceride level are slightly elevated at 600 mg/kg bw/d - vacuolization of hepatocytes from day 3 on at 300 and 600 mg/kg bw/d. 4.     Stomach - hyperplasia and ulcers in non-glandular and glandular stomach. Based on the above mentioned effects the NOAEL was set at 100 mg/kg bw/d. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f256e11c-9787-457a-82a0-60bf75c2614b/documents/IUC5-4292496f-9603-4d67-9ed7-5262c5f47516_43054af4-3bb7-41f8-9818-3c1ab94eb4cf.html,,,,,, "Ethylene bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]",32509-66-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f256e11c-9787-457a-82a0-60bf75c2614b/documents/IUC5-4292496f-9603-4d67-9ed7-5262c5f47516_43054af4-3bb7-41f8-9818-3c1ab94eb4cf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Ethylene bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]",32509-66-3,"Acute toxicity after single oral application was tested in female rats, which received 15,000 mg/kg bw. No animal died or showed clinical symptoms/macroscopic anomalies. The necropsy did not reveal any effect. The LD50 value for acute oral toxicity was considered to be greater than 15,000 mg/kg bw. Due to the findings described above (LD50 oral in rats greater than 15,000 mg/kg bw) Ethylene-bis[3,3-bis(3-tert.-butyl-4-hydroxyphenyl)butyrate]does not have to be classified as acute orally toxic. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f256e11c-9787-457a-82a0-60bf75c2614b/documents/IUC5-7b4af0ce-c5f1-46e5-9350-eee9e6c4319e_43054af4-3bb7-41f8-9818-3c1ab94eb4cf.html,,,,,, "Ethylene bis[3,3-bis(3-tert-butyl-4-hydroxyphenyl)butyrate]",32509-66-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f256e11c-9787-457a-82a0-60bf75c2614b/documents/IUC5-7b4af0ce-c5f1-46e5-9350-eee9e6c4319e_43054af4-3bb7-41f8-9818-3c1ab94eb4cf.html,,oral,LD50,"15,000 mg/kg bw",adverse effect observed, Ethylene di(acetate),111-55-7," Oral (OECD 408), rat, NOAEL (males) ≥ 300 mg/kg bw/day, NOAEL (females) ≥ 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72ae152e-b2dc-47b2-8eea-697d3b2e9384/documents/ff0a898c-9076-44d4-ad7d-765d891801fc_67a0da77-0403-4f76-aed0-ff80d0c4851c.html,,,,,, Ethylene di(acetate),111-55-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72ae152e-b2dc-47b2-8eea-697d3b2e9384/documents/ff0a898c-9076-44d4-ad7d-765d891801fc_67a0da77-0403-4f76-aed0-ff80d0c4851c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Ethylene di(acetate),111-55-7," Oral, rat: LD50 = 6860 mg/kg bw Oral, guinea pig: LD50 = 4940 mg/kg bw Inhalation (OECD 403), rat: LC50 = 0.845 mg/L air, corresponding to 129 ppm Read across from structural analogue source substance propane-1,2-diyl diacetate (CAS 623-84-7). Dermal (OECD 402), rabbit: LD50 > 2000 mg/kg bw Read across from structural analogue source substance propane-1,2-diyl diacetate (CAS 623-84-7). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72ae152e-b2dc-47b2-8eea-697d3b2e9384/documents/fb7135f5-f0b7-430d-9c7f-93199566f8d8_67a0da77-0403-4f76-aed0-ff80d0c4851c.html,,,,,, Ethylene di(S-thioacetate),123-81-9,"Based on the read-across approach, GDMA is expected to show similar effects compard to NaTG. After correction for molecular weight differences the NOEAL of GDMA for repeated dose toxicity is predicted to be 37 mg/kg bw/d (13 wk repeated dose toxicity study, oral, rat, NaTG) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available key studies are reliable or reliable with restrictions (Klimisch 1 – 2) and were conducted according to or similar to guidelines. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e935a4a-e684-4bb8-9785-a38221949fb8/documents/8ce659c3-8b2e-46d1-af91-93d572fcc94d_248ba6b1-f871-43fd-8ccf-8f062ff9f714.html,,,,,, Ethylene di(S-thioacetate),123-81-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e935a4a-e684-4bb8-9785-a38221949fb8/documents/8ce659c3-8b2e-46d1-af91-93d572fcc94d_248ba6b1-f871-43fd-8ccf-8f062ff9f714.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,37 mg/kg bw/day,,rat Ethylene dibenzoate,94-49-5," In a combined OECD 422/408 study at 1000 mg/kg bw/d decreased T4 levels were observed at 1000 mg/kg, of which adversity could not be excluded. In females treated at 1000 mg/kg bw/d microscopic examination revealed an increased incidence of follicular cell hypertrophy (minimal or slight) in the thyroid. This was accompanied by a decrease of thyroid hormone T4 (on average 19%). In males treated at 1000 mg/kg serum levels of thyroid hormone T4 were also decreased (on average by 57%), unaccompanied by treatment related changes in thyroid weight or morphology. For both males and females no corroborative findings were observed in TSH levels.  In order assess the possible hazard for human thyroid insufficiency in adults as well as pre- and post-natal neurological development of offspring, a developmental neurotoxicity study (OECD 426) has been performed. This study showed now adverse effects up to 1000 mg/kg. Specifically, thyroid hormone analysis (T3, T4 and TSH) on post-natal day 21 and 70 showed no effects. And additional developmental toxicity study (OECD 414) performed which included evaluation of thyroid hormones (TSH, T4 and T3), also did not confirm specific effects on the thyroid hormones, and thyroid histopathology showed no effects for the treated females up to 1000 mg/kg. As there are no consistent effects on thyroid hormones observed from the various studies that included serum hormone evaluations, i.e. in 90-day/repro screen (OECD 408/422), developmental neuro toxicity testing (OECD 426) and prenatal developmental toxicity testing in rat (OECD 414). Also in view of the absence of clear adverse effects in any of these studies, the overall NOAEL for repeated dose can be set at 1000 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85ac3491-a04e-4325-b8d4-a86c80138647/documents/e170cba7-5f00-4cb5-b6f3-599ea1ef9711_496f9e30-d1b2-464a-9f54-4ee56abd7f27.html,,,,,, Ethylene dibenzoate,94-49-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85ac3491-a04e-4325-b8d4-a86c80138647/documents/e170cba7-5f00-4cb5-b6f3-599ea1ef9711_496f9e30-d1b2-464a-9f54-4ee56abd7f27.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Ethylene dibenzoate,94-49-5, In an acute oral and dermal toxicity study with rats an LD50 >2000 mg/kg bw for Ethylene glycol dibenzoate was determined. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85ac3491-a04e-4325-b8d4-a86c80138647/documents/bc31359a-3e90-4091-86e0-cf749ef41e8a_496f9e30-d1b2-464a-9f54-4ee56abd7f27.html,,,,,, Ethylene dinitrate,628-96-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e81f3b5-0ae6-4ce6-9973-b3a9e6feed64/documents/fe4bdfd1-84aa-4eed-a536-325ad4773b3c_8033ddf3-df27-464d-9def-7a0c24c71af8.html,Chronic toxicity – systemic effects,oral,NOAEL,3.04 mg/kg bw/day,,rat Ethylene dinitrate,628-96-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e81f3b5-0ae6-4ce6-9973-b3a9e6feed64/documents/fe4bdfd1-84aa-4eed-a536-325ad4773b3c_8033ddf3-df27-464d-9def-7a0c24c71af8.html,Chronic toxicity – systemic effects,dermal,LOAEL,15 mg/kg bw/day,,rabbit Ethylene dinitrate,628-96-6," Three acute oral toxicity studies and one acute dermal toxicity study were available from which to select the effect levels below. No acute inhalation studies were available. However, acute exposure modeling indicated that the acute air concentration was below the DNEL for long-term exposure. Given that the long-term DNEL would be protective of both long-term and acute effects, derivation of a separate DNEL for acute exposure was not considered necessary.  The value provided as the inhalation LC50 below is equivalent to the long-term inhalation DNEL. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e81f3b5-0ae6-4ce6-9973-b3a9e6feed64/documents/ab85f10e-e69a-4da2-80fa-84228bc0d545_8033ddf3-df27-464d-9def-7a0c24c71af8.html,,,,,, Ethylene dinitrate,628-96-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e81f3b5-0ae6-4ce6-9973-b3a9e6feed64/documents/ab85f10e-e69a-4da2-80fa-84228bc0d545_8033ddf3-df27-464d-9def-7a0c24c71af8.html,,oral,LD50,460 mg/kg bw,, Ethylene dinitrate,628-96-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e81f3b5-0ae6-4ce6-9973-b3a9e6feed64/documents/ab85f10e-e69a-4da2-80fa-84228bc0d545_8033ddf3-df27-464d-9def-7a0c24c71af8.html,,dermal,LD50,"3,800 mg/kg bw",, Ethylene dinitrate,628-96-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e81f3b5-0ae6-4ce6-9973-b3a9e6feed64/documents/ab85f10e-e69a-4da2-80fa-84228bc0d545_8033ddf3-df27-464d-9def-7a0c24c71af8.html,,inhalation,LC50,0.085 mg/m3,, Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate],36443-68-2," The substance caused an adaptive enlargement of liver and thyroid upon repeated oral exposure to rats as observed in a subchronic feeding study and a subchronic gavage study. The NOELs were 50 mg/kg bw and 11 mg/kg bw for gavage and feed application, respectively. No adverse effects were observed in a 90-day feeding study in dogs at the highest tested dose of 300 mg/kg bw as applied in a capsule. In a follow up 28-day study in cynomolgus monkey which was designed to investigate liver and thyroid effects, no adverse effects were observed  at the highest tested dose of 1000 mg/kg bw. Based on the absence of effects in dog and monkey, the liver and thyroid effects are rat specific findings and the substance is not expected to pose a hazard for human health. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e55fdea7-6fe9-4d01-9eee-c20eb62e4ed0/documents/IUC5-1cec5d4c-23a0-46b5-9383-2e0d4493db8f_d87a21ad-644d-4969-95de-0043b9690877.html,,,,,, Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate],36443-68-2, The substance is of low toxicity after single oral administration to rats and hamsters. No mortality and no signs of toxicity were observed in a study for acute dermal toxicity in rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e55fdea7-6fe9-4d01-9eee-c20eb62e4ed0/documents/IUC5-3a8a99fd-4621-491e-b281-c7ae9cb6a187_d87a21ad-644d-4969-95de-0043b9690877.html,,,,,, Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate],36443-68-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e55fdea7-6fe9-4d01-9eee-c20eb62e4ed0/documents/IUC5-3a8a99fd-4621-491e-b281-c7ae9cb6a187_d87a21ad-644d-4969-95de-0043b9690877.html,,oral,LD50,"7,000 mg/kg bw",no adverse effect observed, Ethylenebis(oxyethylene) bis[3-(5-tert-butyl-4-hydroxy-m-tolyl)propionate],36443-68-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e55fdea7-6fe9-4d01-9eee-c20eb62e4ed0/documents/IUC5-3a8a99fd-4621-491e-b281-c7ae9cb6a187_d87a21ad-644d-4969-95de-0043b9690877.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Ethylenediamine, propoxylated",25214-63-5,"A 28 -day oral (gavage) repeated dose NOAEL for (male/female) >= 1000 mg/kg b. w. /d is available for the substance (OECD 422).Read across from testing with ethylenediamine, ethoxylated and propoxylated for the 90-day subchronic endpoint: a 90 -day oral (gavage) repeated dose guideline study (OECD 408) resulted with a NOEL for systemic toxicity of 300 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c58747fb-f67e-4bfa-8efb-4baeb6de3081/documents/d96f98d6-c2b8-4b6f-ba4e-3fabd30af031_b29418b9-a034-47ea-ac08-9c9dd0c3b307.html,,,,,, "Ethylenediamine, propoxylated",25214-63-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c58747fb-f67e-4bfa-8efb-4baeb6de3081/documents/d96f98d6-c2b8-4b6f-ba4e-3fabd30af031_b29418b9-a034-47ea-ac08-9c9dd0c3b307.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Ethylenediamine, propoxylated",25214-63-5,Acute toxicity via oral and dermal route were determined to be > 2000 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c58747fb-f67e-4bfa-8efb-4baeb6de3081/documents/IUC5-01d50ba7-55e5-413e-aedf-df66ea135a41_b29418b9-a034-47ea-ac08-9c9dd0c3b307.html,,,,,, "Ethylenediamine, salt with phosphoric acid",14852-17-6,"Data available for the read across substances for test chemical,CAS 14852-17-6 (Target) have been reviewed for repeated dose toxicity Short term repeated dose toxicity study (OECD 407 ) The No Observed Adverse Effect Level (NOAEL) for the test chemical, 1,2-Ethanediamine, phosphate , CAS 14852-17-6 was observed to be 600 mg/kg bw after the administration of the test chemical to Wistar rats, for 28 days and with 2 weeks recovery period.    Subchronic oral toxicity The read across chemical, Ethylenediamine, CAS -107-15-3 was estimated to exert toxic effects on eye and kidney, based on the results, the Low Observed Adverse Effect Level (LOAEL) for the test chemical, Ethylenediamine, CAS 107-15-3 was considered to be 100 mg/kg bw/day when treated in male and female rats.   Short term repeated dose inhalation toxicity The estimated vapour pressure of test substance at 25 Deg C was 0.000144 Pa. so the potential for the generation of inhalable vapors is very low. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be highly unlikely. Therefore this end point for repeated inhalation toxicity is considered as waiver.    Short term repeated dose dermal toxicity The acute dermal toxicity value for ethylenediamine, salt with phosphoric acid (CAS no 14852-17-6) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver.     ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ccf05de-cba5-436d-8842-91b3b5897b36/documents/b3fe9a02-164f-42ec-8fc9-a87a5aa10bc8_645c277d-a861-466d-beaf-f9145433685d.html,,,,,, "Ethylenediamine, salt with phosphoric acid",14852-17-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ccf05de-cba5-436d-8842-91b3b5897b36/documents/b3fe9a02-164f-42ec-8fc9-a87a5aa10bc8_645c277d-a861-466d-beaf-f9145433685d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat "Ethylenediamine, salt with phosphoric acid",14852-17-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ccf05de-cba5-436d-8842-91b3b5897b36/documents/b3fe9a02-164f-42ec-8fc9-a87a5aa10bc8_645c277d-a861-466d-beaf-f9145433685d.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,200 mg/kg bw/day,,rat "Ethylenediamine, salt with phosphoric acid",14852-17-6,"Acute oral toxicity: Based on the available study data of the target test chemical Ethylenediamine, salt with phosphoric acid (Cas 14852-17-6) was tested on the Wistar rat, LD50 value is greater than 2000 mg/kg. Therefore the test chemical is not classified for oral toxicity according to the GLP criteria. Acute Dermal Toxicity: According to the results obtained from a test conducted on male/female Wistar albino rats, it was found that the target test chemical ethylenediamine, salt with phosphoric acid (Cas 14852-17-6) has a lethal dose (LD50) is greater than 2000 mg/kg bw. Based on this value it can be concluded that ethylenediamine, salt with phosphoric acid is not toxic via dermal route as per the criteria of CLP regulation. Acute Inhalation toxicity : the study does not need to be conducted because exposure of humans via inhalation is not likely to take into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The vapour pressure of ethylenediamine, salt with phosphoric acid is very low ( 0.000000034 Pa at 25 deg C). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ccf05de-cba5-436d-8842-91b3b5897b36/documents/095950de-60ed-470a-bc6d-25a3dc3d6dd9_645c277d-a861-466d-beaf-f9145433685d.html,,,,,, "Ethylenediamine, salt with phosphoric acid",14852-17-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ccf05de-cba5-436d-8842-91b3b5897b36/documents/095950de-60ed-470a-bc6d-25a3dc3d6dd9_645c277d-a861-466d-beaf-f9145433685d.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Ethylenediamine, salt with phosphoric acid",14852-17-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ccf05de-cba5-436d-8842-91b3b5897b36/documents/095950de-60ed-470a-bc6d-25a3dc3d6dd9_645c277d-a861-466d-beaf-f9145433685d.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Ethylenediamine-N,N'-di(acetic acid)",5657-17-0,There are no repeated dose studies with the substance available. Studies on two structural analogues of the substance (Na3H-EDTA and Na2H2-EDTA) are available (for read-across justification refer to Section 13) which indicate no significant concerns for toxicity/carcinogenicity. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6180dcf-2359-450c-9370-1f514bfd38ea/documents/26a122bc-d380-448f-8524-455ddbba3e40_b8d6179e-3605-41d6-a570-4a48b072afc8.html,,,,,, "Ethylenediamine-N,N'-di(acetic acid)",5657-17-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6180dcf-2359-450c-9370-1f514bfd38ea/documents/26a122bc-d380-448f-8524-455ddbba3e40_b8d6179e-3605-41d6-a570-4a48b072afc8.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Ethylenediamine-N,N'-di(acetic acid)",5657-17-0," Acute oral toxicity - Weight of evidence suggests the median lethal dose to be close to 2000 mg/kg. In the absence of reliable data on the substance itself a key, well documented study, on the analogue tetrasodium EDTA describes the LD50 of that substance as being 1780 mg/kg. This is used to characterise the acute toxicity of this substance and the LD50, re-based according to the molecular weight of the two substances, is therefore taken as being 1303 mg/kg. Acute inhalation toxicity - The LC50(4h) for the structurally related substance Na3-HEDTA is in excess of 3.95 mg/L, the highest exposure concentration achievable. Acute dermal toxicity - No relevant data available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6180dcf-2359-450c-9370-1f514bfd38ea/documents/ded6422f-3acf-42bc-8193-c6833ee7e751_b8d6179e-3605-41d6-a570-4a48b072afc8.html,,,,,, "Ethylenediamine-N,N'-di(acetic acid)",5657-17-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6180dcf-2359-450c-9370-1f514bfd38ea/documents/ded6422f-3acf-42bc-8193-c6833ee7e751_b8d6179e-3605-41d6-a570-4a48b072afc8.html,,oral,LD50,"1,303 mg/kg bw",adverse effect observed, "Ethylenediamine-N,N'-di(acetic acid)",5657-17-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6180dcf-2359-450c-9370-1f514bfd38ea/documents/ded6422f-3acf-42bc-8193-c6833ee7e751_b8d6179e-3605-41d6-a570-4a48b072afc8.html,,inhalation,discriminating conc.,"3,950 mg/m3",no adverse effect observed, Ethylenediaminetetraacetonitrile,5766-67-6,See for data at section 7.8.1 toxicity to reproduction where an OECD 421 study has been summarized. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/712d2d63-a39c-4aa4-85b0-841327cdd7d0/documents/IUC5-a965c36c-07f6-42a8-b6ed-a5ac4090fba6_2fd110a5-0a3e-445b-a058-1484ee078a3e.html,,,,,, Ethylenediaminetetraacetonitrile,5766-67-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/712d2d63-a39c-4aa4-85b0-841327cdd7d0/documents/IUC5-a965c36c-07f6-42a8-b6ed-a5ac4090fba6_2fd110a5-0a3e-445b-a058-1484ee078a3e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Ethylenediaminetetraacetonitrile,5766-67-6,An oral and dermal acute toxicity study were available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/712d2d63-a39c-4aa4-85b0-841327cdd7d0/documents/IUC5-2fbf78a5-7303-4f48-b56f-207d29699e08_2fd110a5-0a3e-445b-a058-1484ee078a3e.html,,,,,, Ethylidynetrimethanol,77-85-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline study rated Klimisch 1 (relaiable without restriction). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e696a37-405f-4bfa-bd8d-7ed0e2c8e3f1/documents/f64b72e8-46f7-49a8-852b-dc59dc14799b_e6351983-ef84-4ad4-b676-f224e0c3cb95.html,,,,,, Ethylidynetrimethanol,77-85-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e696a37-405f-4bfa-bd8d-7ed0e2c8e3f1/documents/f64b72e8-46f7-49a8-852b-dc59dc14799b_e6351983-ef84-4ad4-b676-f224e0c3cb95.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Ethylidynetrimethanol,77-85-0," Acute oral, dermal and inhalation toxicity to rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e696a37-405f-4bfa-bd8d-7ed0e2c8e3f1/documents/69f035de-2951-430b-89bc-5b10bd7c054b_e6351983-ef84-4ad4-b676-f224e0c3cb95.html,,,,,, Ethylidynetrimethanol,77-85-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e696a37-405f-4bfa-bd8d-7ed0e2c8e3f1/documents/69f035de-2951-430b-89bc-5b10bd7c054b_e6351983-ef84-4ad4-b676-f224e0c3cb95.html,,oral,LD50,"14,700 mg/kg bw",no adverse effect observed, Ethylidynetrimethanol,77-85-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e696a37-405f-4bfa-bd8d-7ed0e2c8e3f1/documents/69f035de-2951-430b-89bc-5b10bd7c054b_e6351983-ef84-4ad4-b676-f224e0c3cb95.html,,dermal,LD50,"10,000 mg/kg bw",no adverse effect observed, Ethylidynetrimethanol,77-85-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e696a37-405f-4bfa-bd8d-7ed0e2c8e3f1/documents/69f035de-2951-430b-89bc-5b10bd7c054b_e6351983-ef84-4ad4-b676-f224e0c3cb95.html,,inhalation,LC50,850 mg/m3,no adverse effect observed, Ethyltriphenylfosfonium bromide,1530-32-1,"Repeated Dose Toxicity (Oral): OECD 407 study: NOAEL was found at 120 mg/kg bw/day (rats: oral gavage), which was the highest dose tested in the study. Severe toxicological effects were observed in the DRF study at 200 mg/kg bw/day from the 5th day of dosing and onwards.The study was performed according to GLP and was scored as a Klimisch 1 study. OECD 408 study: NOAEL was found at 70 mg/kg bw/day (rats: oral gavage), which was the middle dose tested in the study. LOAEL was determined at 100 mg/kg bw/day, which was the top dose level in the study after dose de-escalation from 140 to 100 mg/kg bw/day on treatment day 45 based on observd mortality and morbidity between treatment day 44-45. The adverse effects seen after dose de-escalation to 100 mg/kg bw/day included clinical signs of toxicity (lethargy) and adverse effects on body weight, food intake, and locomotor activity.The study was performed according to GLP and was scored as a Klimisch 1 study. Repeated Dose Toxicity (Inhalation): According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the test chemical  which is reported as 6.600541739463232e-8 mmHg at 25 degree C. Also, considering the particle size distribution of the substance the majority of the particles was found to be in the range size of 150 micron to 106 micron which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the test chemical is highly unlikely. Therefore this study was considered for waiver.   Repeated Dose Toxicity (Dermal): The acute toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that the test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that the test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13268315-4846-4553-ad1f-0b109e6d1294/documents/ce3efd46-bc27-4a4c-a70a-299b9368aa05_52b01331-5c77-4806-858c-0240911368f9.html,,,,,, Ethyltriphenylfosfonium bromide,1530-32-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13268315-4846-4553-ad1f-0b109e6d1294/documents/ce3efd46-bc27-4a4c-a70a-299b9368aa05_52b01331-5c77-4806-858c-0240911368f9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat Ethyltriphenylfosfonium bromide,1530-32-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13268315-4846-4553-ad1f-0b109e6d1294/documents/ce3efd46-bc27-4a4c-a70a-299b9368aa05_52b01331-5c77-4806-858c-0240911368f9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,70 mg/kg bw/day,,rat Ethyltriphenylfosfonium bromide,1530-32-1,"Acute oral toxicity:  An acute oral toxicity dose (LD50) of the test chemical was considered based on experimental study conducted on rats, the LD50 value was considered in between 50-300 mg/kg bw in rats. Thus, comparing this range with the criteria of CLP regulation, the given test chemical can be classified in “Category 3” for acute oral toxicity.   Acute Inhalation toxicity:  An acute inhalation toxicity dose (LC50) of the test chemical was considered based on experimental study conducted on rats, the LC50 value was considered to be >5.0 mg/L (>5000 mg/m3) in rats. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute inhalation toxicity.   Acute Dermal Toxicity: An acute Dermal toxicity dose (LD50) of the test chemical was considered based on experimental study conducted on rats, the value was considered to be >2000 mg/kg bw in rats. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13268315-4846-4553-ad1f-0b109e6d1294/documents/030c1bb3-a3fd-4cf9-97b5-54926a84648e_52b01331-5c77-4806-858c-0240911368f9.html,,,,,, Ethyltriphenylfosfonium bromide,1530-32-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13268315-4846-4553-ad1f-0b109e6d1294/documents/030c1bb3-a3fd-4cf9-97b5-54926a84648e_52b01331-5c77-4806-858c-0240911368f9.html,,oral,LD50,150 mg/kg bw,adverse effect observed, Ethyltriphenylfosfonium bromide,1530-32-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13268315-4846-4553-ad1f-0b109e6d1294/documents/030c1bb3-a3fd-4cf9-97b5-54926a84648e_52b01331-5c77-4806-858c-0240911368f9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ethyltriphenylfosfonium bromide,1530-32-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13268315-4846-4553-ad1f-0b109e6d1294/documents/030c1bb3-a3fd-4cf9-97b5-54926a84648e_52b01331-5c77-4806-858c-0240911368f9.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Ethyltriphenylphosphonium acetate,35835-94-0," The oral administration of ETPPAAc to rats by gavage, at dose levels of 10, 25 and 75 mg/kg bw/day, resulted in microscopic stomach changes in males treated with 75 mg/kg bw/day. The ‘No Observed Effect Level’ (NOEL) for systemic toxicity was therefore considered to be 75 mg/kg bw/day for females and 25 mg/kg bw/day for males. The reduced body weight development and microscopic changes evident in the stomach were considered to be the result of an irritant effect of the test item rather than a true systemic effect and as such was considered adaptive and non-adverse. Therefore, a ‘No Observed Adverse Effect Level’ (NOAEL) can be established at 75 mg/kg bw/day for males. The ‘No Observed Effect Level’ (NOEL) for reproductive/developmental toxicity was considered to be 75 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5fd71f5-2789-4608-a4da-fc0517ff50e5/documents/5ef59dc2-19bb-4864-b7a4-86c129e6af03_a0c7f3df-2d90-49e4-aea5-7dab5e73deb2.html,,,,,, Ethyltriphenylphosphonium acetate,35835-94-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5fd71f5-2789-4608-a4da-fc0517ff50e5/documents/5ef59dc2-19bb-4864-b7a4-86c129e6af03_a0c7f3df-2d90-49e4-aea5-7dab5e73deb2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat Ethyltriphenylphosphonium acetate,35835-94-0," Acute oral toxicity: LD50 126 mg/kg bw, OECD Guideline 401; RL2   Acute inhalation toxicity: exposure consideration; no testing required    Acute dermal toxicity: LD50 1437 mg/kg bw, OECD Guideline 402 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5fd71f5-2789-4608-a4da-fc0517ff50e5/documents/23c1ec0f-e08a-4f1e-aaa0-6cb12b136d75_a0c7f3df-2d90-49e4-aea5-7dab5e73deb2.html,,,,,, Ethyltriphenylphosphonium acetate,35835-94-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5fd71f5-2789-4608-a4da-fc0517ff50e5/documents/23c1ec0f-e08a-4f1e-aaa0-6cb12b136d75_a0c7f3df-2d90-49e4-aea5-7dab5e73deb2.html,,oral,LD50,126 mg/kg bw,adverse effect observed, Ethyltriphenylphosphonium acetate,35835-94-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5fd71f5-2789-4608-a4da-fc0517ff50e5/documents/23c1ec0f-e08a-4f1e-aaa0-6cb12b136d75_a0c7f3df-2d90-49e4-aea5-7dab5e73deb2.html,,dermal,LD50,"1,437 mg/kg bw",adverse effect observed, Ethyltriphenylphosphonium iodide,4736-60-1," Oral: LD50 (rat, m/f) >25 - <200 mg/kg bw (OECD 423/EU B.1 tris, GLP) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f1e4d7b-62f2-431d-b4f4-375723e34841/documents/821f5a35-c206-4f0d-b44c-cf4a36a78c68_01699eb0-7cc9-4219-90c5-45494cab21e6.html,,,,,, Ethyltriphenylphosphonium iodide,4736-60-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f1e4d7b-62f2-431d-b4f4-375723e34841/documents/821f5a35-c206-4f0d-b44c-cf4a36a78c68_01699eb0-7cc9-4219-90c5-45494cab21e6.html,,oral,discriminating dose,25 mg/kg bw,adverse effect observed, Ethyltris(2-hydroxyethyl)ammonium ethyl sulphate,31774-90-0," Under the conditions of the present study, a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality. The median lethal dose of the test item after a single oral administration to female rats, observed over a period of 14 days is, according to OECD Guideline 423, Annex 2: LD50 cut-off (rat): 5000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b062636-baeb-45b8-8826-6b6f72591154/documents/ef448ef7-db99-49b2-9601-514583da8afa_9b5420c7-0d36-49bc-8134-d8697c5a002e.html,,,,,, Ethyltris(2-hydroxyethyl)ammonium ethyl sulphate,31774-90-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b062636-baeb-45b8-8826-6b6f72591154/documents/ef448ef7-db99-49b2-9601-514583da8afa_9b5420c7-0d36-49bc-8134-d8697c5a002e.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, ethynyl cyclopropane,6746-94-7,"oralrat (EU method B.7) NOAEL (m/f): 1000 mg/kg bw/day (DuPont Merck, 1997)dermalActually, there is no information available.inhalationActually, there is no information available. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/30336960-8b7c-4292-940c-7788716d75b7/documents/IUC5-32195b58-f7a3-4b6e-bfee-3aa11e1c08d5_4e12e6d0-bbd3-4d47-8045-2665c5150088.html,,,,,, ethynyl cyclopropane,6746-94-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/30336960-8b7c-4292-940c-7788716d75b7/documents/IUC5-32195b58-f7a3-4b6e-bfee-3aa11e1c08d5_4e12e6d0-bbd3-4d47-8045-2665c5150088.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, ethynyl cyclopropane,6746-94-7,"Acute Oral toxicityRat: LD50 (m/f) > 2000 mg/kg bw (EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure); DuPont Merck, 1997) Acute Inhalation toxicityRat: LC50 (m/f) > 22.3 mg/l (OECD 403; DuPont Merck, 1997)Acute Dermal toxicityRat: LD50 (m/f) > 2000 mg/kg bw (EU method B.3 Acute Toxicity (Dermal); DuPont Merck, 1997) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30336960-8b7c-4292-940c-7788716d75b7/documents/IUC5-fe2f6b7d-d10e-41ce-ad62-139360e4a216_4e12e6d0-bbd3-4d47-8045-2665c5150088.html,,,,,, ethynyl cyclopropane,6746-94-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30336960-8b7c-4292-940c-7788716d75b7/documents/IUC5-fe2f6b7d-d10e-41ce-ad62-139360e4a216_4e12e6d0-bbd3-4d47-8045-2665c5150088.html,,oral,LD50,"2,000 mg/kg bw",, ethynyl cyclopropane,6746-94-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30336960-8b7c-4292-940c-7788716d75b7/documents/IUC5-fe2f6b7d-d10e-41ce-ad62-139360e4a216_4e12e6d0-bbd3-4d47-8045-2665c5150088.html,,dermal,LD50,"2,000 mg/kg bw",, ethynyl cyclopropane,6746-94-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30336960-8b7c-4292-940c-7788716d75b7/documents/IUC5-fe2f6b7d-d10e-41ce-ad62-139360e4a216_4e12e6d0-bbd3-4d47-8045-2665c5150088.html,,inhalation,LC50,22.3 mg/m3,, Exo-1-methyl-4-(1-methylethyl)-7-oxabicyclo[2.2.1]heptan-2-ol,87172-89-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/95f22eec-f1f8-4bde-ad64-526ff3674bf3/documents/bb167fc8-2a5f-42bb-bb64-c69a1a6e2cd5_0b4b73df-2474-4e61-97fe-7325527bf174.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Exo-1-methyl-4-(1-methylethyl)-7-oxabicyclo[2.2.1]heptan-2-ol,87172-89-2," Acute oral toxicity: The LD50 for male and female rats were calculated to be 1429 mg/kg (95% CI: 1169 -1689) and 1053 mg/kg (95% CI: 952 - 1154), respectively. The combined LD50 was calculated to be 1293 mg/kg (95% CI: 1123 -1464). Acute inhalative toxicity: Based on the available data, an LC50 of approximately 10 mg/L is assumed. Acute dermal toxicity: The LD50 of the test item in male and female rats was greater than 2000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95f22eec-f1f8-4bde-ad64-526ff3674bf3/documents/ef91c1bb-5a28-45b6-b79f-206f4a1b66f3_0b4b73df-2474-4e61-97fe-7325527bf174.html,,,,,, Exo-1-methyl-4-(1-methylethyl)-7-oxabicyclo[2.2.1]heptan-2-ol,87172-89-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95f22eec-f1f8-4bde-ad64-526ff3674bf3/documents/ef91c1bb-5a28-45b6-b79f-206f4a1b66f3_0b4b73df-2474-4e61-97fe-7325527bf174.html,,oral,LD50,"1,293 mg/kg bw",adverse effect observed, Exo-1-methyl-4-(1-methylethyl)-7-oxabicyclo[2.2.1]heptan-2-ol,87172-89-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95f22eec-f1f8-4bde-ad64-526ff3674bf3/documents/ef91c1bb-5a28-45b6-b79f-206f4a1b66f3_0b4b73df-2474-4e61-97fe-7325527bf174.html,,inhalation,LC50,"10,000 mg/m3",adverse effect observed, "Extracts (petroleum), deasphalted vacuum residue solvent",91995-70-9," There were no repeated dose inhalation studies identified.   Two key 90 -day oral studies (OECD 408) have been conducted, in one study (on CAS 91995 -70 -9) the NOAEL was determined to be 1000 mg/kg/day for both males and females. In the other study (on CAS 64742 -10 -5) possible relationship between test item and one unscheduled death (male at 1000 mg/kg/day) and microscopic findings in brain and spinal cord (females at 300 and 1000 mg/kg/day) meant the NOAEL was 100 and 300 mg/kg/day for females and males respectively. A key 90-day dermal toxicity study (OECD 411) examined RAE substances in male and female rats and determined a NOAEL of 500 mg/kg/day for Mobilsol 40; however, a NOAEL could not be clearly established for the BSE Australia, Ninian and Statjford since only a single dose level was evaluated for these three extracts. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfcdd4ee-2e5f-4b24-aaed-1beca699d5f6/documents/9080286c-580d-41be-b568-d1ab63634ba1_96f9aaab-8261-452b-b744-c42ff905fadc.html,,,,,, "Extracts (petroleum), deasphalted vacuum residue solvent",91995-70-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfcdd4ee-2e5f-4b24-aaed-1beca699d5f6/documents/9080286c-580d-41be-b568-d1ab63634ba1_96f9aaab-8261-452b-b744-c42ff905fadc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Extracts (petroleum), deasphalted vacuum residue solvent",91995-70-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfcdd4ee-2e5f-4b24-aaed-1beca699d5f6/documents/9080286c-580d-41be-b568-d1ab63634ba1_96f9aaab-8261-452b-b744-c42ff905fadc.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rat "Extracts (petroleum), deasphalted vacuum residue solvent",91995-70-9,"Key read across acute oral (similar to OECD 401), dermal (similar to OECD 402), and inhalation (OECD 403)  toxicity studies were identified and used to predict the acute toxicity values for RAE.• The oral LD50 was > 5000 mg/kg bw in male and female rats.• The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits.• The inhalation (aerosol) LC50 was > 5 mg/L (or > 5000 mg/m3) in male and female rats. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfcdd4ee-2e5f-4b24-aaed-1beca699d5f6/documents/a5a62f07-028b-497f-b7f5-c9d6b6bd8d8f_96f9aaab-8261-452b-b744-c42ff905fadc.html,,,,,, "Extracts (petroleum), deasphalted vacuum residue solvent",91995-70-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfcdd4ee-2e5f-4b24-aaed-1beca699d5f6/documents/a5a62f07-028b-497f-b7f5-c9d6b6bd8d8f_96f9aaab-8261-452b-b744-c42ff905fadc.html,,oral,LD50,"5,000 mg/kg bw",, "Extracts (petroleum), deasphalted vacuum residue solvent",91995-70-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfcdd4ee-2e5f-4b24-aaed-1beca699d5f6/documents/a5a62f07-028b-497f-b7f5-c9d6b6bd8d8f_96f9aaab-8261-452b-b744-c42ff905fadc.html,,dermal,LD50,"3,000 mg/kg bw",, "Extracts (petroleum), deasphalted vacuum residue solvent",91995-70-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfcdd4ee-2e5f-4b24-aaed-1beca699d5f6/documents/a5a62f07-028b-497f-b7f5-c9d6b6bd8d8f_96f9aaab-8261-452b-b744-c42ff905fadc.html,,inhalation,LC50,"5,000 mg/m3",, "Extracts (petroleum), heavy naphtha solvent",64741-98-6,"There are data for repeat exposure to one low benzene naphtha streams representing the inhalation route of exposure and a related stream representing the dermal route. These do not indicate any specific target organ toxicity which would warrant classification. However, there are substantial data on the repeated dose toxicity of toluene which demonstrates significant target organ toxicity and, when present at concentrations greater than or equal to 10%, this component substance will influence classification due to mammalian toxicity effects. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/54ca2501-b65f-4959-9942-2617626fff40/documents/a7f018ae-d769-4637-b4fa-9742962b2abb_5b0b30b7-d3ec-40d1-9444-90c22423a190.html,,,,,, "Extracts (petroleum), heavy naphtha solvent",64741-98-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/54ca2501-b65f-4959-9942-2617626fff40/documents/a7f018ae-d769-4637-b4fa-9742962b2abb_5b0b30b7-d3ec-40d1-9444-90c22423a190.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rabbit "Extracts (petroleum), heavy naphtha solvent",64741-98-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/54ca2501-b65f-4959-9942-2617626fff40/documents/a7f018ae-d769-4637-b4fa-9742962b2abb_5b0b30b7-d3ec-40d1-9444-90c22423a190.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,625 mg/kg bw/day,,rat "Extracts (petroleum), heavy naphtha solvent",64741-98-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/54ca2501-b65f-4959-9942-2617626fff40/documents/a7f018ae-d769-4637-b4fa-9742962b2abb_5b0b30b7-d3ec-40d1-9444-90c22423a190.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,131 mg/m3",,rat "Extracts (petroleum), heavy naphtha solvent",64741-98-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/54ca2501-b65f-4959-9942-2617626fff40/documents/a7f018ae-d769-4637-b4fa-9742962b2abb_5b0b30b7-d3ec-40d1-9444-90c22423a190.html,Repeated dose toxicity – local effects,dermal,LOAEL,200 mg/cm2,adverse effect observed,rabbit "Extracts (petroleum), heavy naphtha solvent",64741-98-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/54ca2501-b65f-4959-9942-2617626fff40/documents/a7f018ae-d769-4637-b4fa-9742962b2abb_5b0b30b7-d3ec-40d1-9444-90c22423a190.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,131 mg/m3",adverse effect observed,rat "Extracts (petroleum), heavy naphtha solvent",64741-98-6,"Available non-human data for CAS 68516-20-1, a low benzene naphtha stream, and data on the specific component toluene, indicate that acute toxicity is expected to be low. Low benzene naphtha streams do not pose an acute hazard following ingestion (oral LD50 > 2000 mg/kg bw) or skin contact (dermal LD50 > 2000 mg/kg). The acute inhalation 4 hour LC50 is greater than saturated vapour pressure for the stream considered and > 20 mg/L for toluene. However following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and labelling will be required as low benzene naphtha streams contain up to 50% toluene. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54ca2501-b65f-4959-9942-2617626fff40/documents/IUC5-978da215-cc20-4b79-9b82-547be5c9bcb5_5b0b30b7-d3ec-40d1-9444-90c22423a190.html,,,,,, "Extracts (petroleum), heavy naphtha solvent",64741-98-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54ca2501-b65f-4959-9942-2617626fff40/documents/IUC5-978da215-cc20-4b79-9b82-547be5c9bcb5_5b0b30b7-d3ec-40d1-9444-90c22423a190.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Extracts (petroleum), heavy naphtha solvent",64741-98-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54ca2501-b65f-4959-9942-2617626fff40/documents/IUC5-978da215-cc20-4b79-9b82-547be5c9bcb5_5b0b30b7-d3ec-40d1-9444-90c22423a190.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Extracts (petroleum), heavy naphtha solvent",64741-98-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54ca2501-b65f-4959-9942-2617626fff40/documents/IUC5-978da215-cc20-4b79-9b82-547be5c9bcb5_5b0b30b7-d3ec-40d1-9444-90c22423a190.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, "Extracts (petroleum), light naphtha solvent",64741-99-7,"Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene / n-hexane - when present at 10%). Adequate information is available on the constituents to characterise the repeated dermal hazards of these streams. Adequate information is available on the constituents to characterise the repeated inhalation hazards of these streams. Adequate information is available on the constituents to characterise the repeated oral hazards of these streams. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e9fd387-5125-4b2f-98f9-d27e30123048/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_c9adceb3-8891-4a78-8aa5-42533047b2ed.html,,,,,, "Extracts (petroleum), light naphtha solvent",64741-99-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e9fd387-5125-4b2f-98f9-d27e30123048/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_c9adceb3-8891-4a78-8aa5-42533047b2ed.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Extracts (petroleum), light naphtha solvent",64741-99-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e9fd387-5125-4b2f-98f9-d27e30123048/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_c9adceb3-8891-4a78-8aa5-42533047b2ed.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Extracts (petroleum), light naphtha solvent",64741-99-7,"Available data for one stream within this category (CAS 68516-20-1) and data on specific constituents (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Adequate information is available to characterise the short-term hazards of these streams. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e9fd387-5125-4b2f-98f9-d27e30123048/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_c9adceb3-8891-4a78-8aa5-42533047b2ed.html,,,,,, "Extracts (petroleum), light naphtha solvent",64741-99-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e9fd387-5125-4b2f-98f9-d27e30123048/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_c9adceb3-8891-4a78-8aa5-42533047b2ed.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Extracts (petroleum), light naphtha solvent",64741-99-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e9fd387-5125-4b2f-98f9-d27e30123048/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_c9adceb3-8891-4a78-8aa5-42533047b2ed.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Extracts (petroleum), light naphtha solvent",64741-99-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e9fd387-5125-4b2f-98f9-d27e30123048/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_c9adceb3-8891-4a78-8aa5-42533047b2ed.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, "Extracts (petroleum), residual oil solvent",64742-10-5," There were no repeated dose inhalation studies identified.   Two key 90 -day oral studies (OECD 408) have been conducted, in one study (on CAS 91995 -70 -9) the NOAEL was determined to be 1000 mg/kg/day for both males and females. In the other study (on CAS 64742 -10 -5) possible relationship between test item and one unscheduled death (male at 1000 mg/kg/day) and microscopic findings in brain and spinal cord (females at 300 and 1000 mg/kg/day) meant the NOAEL was 100 and 300 mg/kg/day for females and males respectively. A key 90-day dermal toxicity study (OECD 411) examined RAE substances in male and female rats and determined a NOAEL of 500 mg/kg/day for Mobilsol 40; however, a NOAEL could not be clearly established for the BSE Australia, Ninian and Statjford since only a single dose level was evaluated for these three extracts. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dcb7a97b-d19e-4f02-89b6-602b34c06579/documents/9080286c-580d-41be-b568-d1ab63634ba1_4e3045c8-37ee-4914-a5ba-e915305d0a4f.html,,,,,, "Extracts (petroleum), residual oil solvent",64742-10-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dcb7a97b-d19e-4f02-89b6-602b34c06579/documents/9080286c-580d-41be-b568-d1ab63634ba1_4e3045c8-37ee-4914-a5ba-e915305d0a4f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Extracts (petroleum), residual oil solvent",64742-10-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dcb7a97b-d19e-4f02-89b6-602b34c06579/documents/9080286c-580d-41be-b568-d1ab63634ba1_4e3045c8-37ee-4914-a5ba-e915305d0a4f.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rat "Extracts (petroleum), residual oil solvent",64742-10-5,"Key read across acute oral (similar to OECD 401), dermal (similar to OECD 402), and inhalation (OECD 403)  toxicity studies were identified and used to predict the acute toxicity values for RAE.• The oral LD50 was > 5000 mg/kg bw in male and female rats.• The dermal LD50 was > 3000 mg/kg/bw in male and female rabbits.• The inhalation (aerosol) LC50 was > 5 mg/L (or > 5000 mg/m3) in male and female rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcb7a97b-d19e-4f02-89b6-602b34c06579/documents/a5a62f07-028b-497f-b7f5-c9d6b6bd8d8f_4e3045c8-37ee-4914-a5ba-e915305d0a4f.html,,,,,, "Extracts (petroleum), residual oil solvent",64742-10-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcb7a97b-d19e-4f02-89b6-602b34c06579/documents/a5a62f07-028b-497f-b7f5-c9d6b6bd8d8f_4e3045c8-37ee-4914-a5ba-e915305d0a4f.html,,oral,LD50,"5,000 mg/kg bw",, "Extracts (petroleum), residual oil solvent",64742-10-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcb7a97b-d19e-4f02-89b6-602b34c06579/documents/a5a62f07-028b-497f-b7f5-c9d6b6bd8d8f_4e3045c8-37ee-4914-a5ba-e915305d0a4f.html,,dermal,LD50,"3,000 mg/kg bw",, "Extracts (petroleum), residual oil solvent",64742-10-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcb7a97b-d19e-4f02-89b6-602b34c06579/documents/a5a62f07-028b-497f-b7f5-c9d6b6bd8d8f_4e3045c8-37ee-4914-a5ba-e915305d0a4f.html,,inhalation,LC50,"5,000 mg/m3",, "Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction products",1419212-73-9," Female rats (n=1) received a single dose of the test substance at 300 and 2000 mg/kg bw in a sighting study. In absence of mortality or signs of toxicity, additional 4 females were dosed at 2000 mg/kg bw. No mortality was observed in these females and no effects on body weight, clinical signs or gross examination were noted. The study followed the fixed dose procedure without any deviations from the guideline. The LD50 is > 2000 mg/kg bw. Wistar rats (5/sex) were dermally exposed to the substance for 24 hours (semi occlusion) at 2000 mg/kg bw. No mortality, clinical signs or macroscopic changes were seen. Body weight gain was within normal ranges. Most animals showed signs of irritation. The LD50 is > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9620d63-ca3b-418f-9638-0af6c5e619e7/documents/bcaa1084-de10-4257-b8d1-d234354ba0b5_5cb5bc4d-d03d-472f-a66d-5a79d78a0e11.html,,,,,, "Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction products",1419212-73-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9620d63-ca3b-418f-9638-0af6c5e619e7/documents/bcaa1084-de10-4257-b8d1-d234354ba0b5_5cb5bc4d-d03d-472f-a66d-5a79d78a0e11.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fats and Glyceridic oils, vegetable, winterized, reaction products with ammonia-ethanolamine reaction products",1419212-73-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9620d63-ca3b-418f-9638-0af6c5e619e7/documents/bcaa1084-de10-4257-b8d1-d234354ba0b5_5cb5bc4d-d03d-472f-a66d-5a79d78a0e11.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate",1471313-51-5," Based on justified read-across, test results from an available repeated dose toxicity according to OECD TG 408 in accordance with the principles of GLP for the source substance sodium methyl oleyl taurate are used to inform this endpoint. In the repeated dose toxicity in a 90-day subchronic toxicity study of the soure substance, after daily administration of 0, 100, 300 and 750 mg/kg body weight via gavage for 90 consecutive days to rats, no significant differences in mortality, clinical findings, neurobehaviour, clinical biochemistry, urinalysis parameters,  organ weights, or gross pathology were revealed. Increase in white blood cell counts in high dose animals correlates very well with observed inflammatory changes in the forestomach of high and mid dose animals. These forestomach findings are considered to be secondary local effects (""port-of-entry"") but not systemic toxic effects and are not considered relevant for human health hazard / risk assessment. Comparable forestomach effects were not seen in the rats from the low- and mid-dose groups. Since the forestomach changes are considered to be `site of first contact` and thus local effects, the NOAEL with regard to systemic toxicity was established at750mg/kg body weight per day. In addition, data from a 28 -day oral toxicity study on the source molecule sodium methyl oleyl taurate is also used for the registration substance sodium methyl cocoyl taurate as target molecule. A NOAEL of 1000 mg/kg body weight for the oral route was also derived in the supporting 28-day subacute oral toxicity study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cce61310-a7a1-4d68-960b-dd32b939648f/documents/IUC5-a12c8339-234c-4f62-8a2a-5fd3fd55b072_e8b2e1c9-dbce-40fb-9cc3-b91d0e4431e0.html,,,,,, "Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate",1471313-51-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cce61310-a7a1-4d68-960b-dd32b939648f/documents/IUC5-a12c8339-234c-4f62-8a2a-5fd3fd55b072_e8b2e1c9-dbce-40fb-9cc3-b91d0e4431e0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate",1471313-51-5,"With regard to the endpoint acute systemic toxicity, test data for the oral route on the registration substance and for the dermal exposure route on a closely related analogous compound are available. Based on an OECD 423 acute oral toxicity study, the limit dose of 2000 mg/kg body weight revealed no mortality and no clinical signs of intoxication. Macroscopic findings during gross pathology were not observed. Based on the findings the LD 50 was established to be greater than 2000 mg/kg body weight. Based on read-across, the acute dermal toxicity of the registered substance is considered to be greater 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cce61310-a7a1-4d68-960b-dd32b939648f/documents/IUC5-748cef20-c5eb-4a11-bdcb-5d09afaad853_e8b2e1c9-dbce-40fb-9cc3-b91d0e4431e0.html,,,,,, "Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate",1471313-51-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cce61310-a7a1-4d68-960b-dd32b939648f/documents/IUC5-748cef20-c5eb-4a11-bdcb-5d09afaad853_e8b2e1c9-dbce-40fb-9cc3-b91d0e4431e0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acid chlorides, C12-18 (even numbered) and C18 unsatd., reaction products with sodium N-methyltaurinate",1471313-51-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cce61310-a7a1-4d68-960b-dd32b939648f/documents/IUC5-748cef20-c5eb-4a11-bdcb-5d09afaad853_e8b2e1c9-dbce-40fb-9cc3-b91d0e4431e0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acid chlorides, C18 unsatd., reaction products with sodium N-methyltaurinate",1471313-87-7,"The registered substance was tested for repeated dose toxicity in a 90-day subchronic toxicity study according to OECD TG 408 in line with the principles of GLP. After daily administration of 0, 100, 300 and 750 mg/kg body weight via gavage for 90 consecutive days to rats, no significant differences in mortality, clinical findings, neurobehaviour, clinical biochemistry, urinalysis parameters, organ weights, or gross pathology were revealed. Increase in white blood cell counts in high dose animals correlates very well with observed inflammatory changes in the forestomach of high and mid dose animals. These forestomach findings are considered to be secondary local effects (""port-of-entry"") but not systemic toxic effects and are not considered relevant for human health hazard / risk assessment. Comparable forestomach effects were not seen in the rats from the low- and mid-dose groups. Since the forestomach changes are considered to be `site of first contact` and thus local effects, the NOAEL with regard to systemic toxicity was established at 750 mg/kg body weight per day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f659e12-d070-4d02-9f30-efadd968a97a/documents/IUC5-c6d85d93-084b-4519-94c2-a465a6ef8bca_74d51ac8-211f-44bc-ab48-b2bba68d6c98.html,,,,,, "Fatty acid chlorides, C18 unsatd., reaction products with sodium N-methyltaurinate",1471313-87-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f659e12-d070-4d02-9f30-efadd968a97a/documents/IUC5-c6d85d93-084b-4519-94c2-a465a6ef8bca_74d51ac8-211f-44bc-ab48-b2bba68d6c98.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Fatty acid chlorides, C18 unsatd., reaction products with sodium N-methyltaurinate",1471313-87-7,"With regard to the acute toxicity of the registered substance, test data for the oral and dermal exposure route are available. Based on an OECD 423 acute oral toxicity study, the limit dose of 2000 mg/kg body weight revealed no mortality and no clinical signs of intoxication. Macroscopic findings during gross pathology were not observed. Based on the findings the LD 50 was established to be greater than 2000 mg/kg body weight. The acute dermal toxicity of the registered substance was evaluated in an OECD 402 study according to GLP. After topical treatment with the limit dose of 2000 mg/kg body weight neither mortality nor significant clinical symptoms of intoxication were observed. The LD50 after dermal treatment was established to be greater 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f659e12-d070-4d02-9f30-efadd968a97a/documents/IUC5-8ccb59ae-fe6b-41aa-8963-7d206ee24151_74d51ac8-211f-44bc-ab48-b2bba68d6c98.html,,,,,, "Fatty acid chlorides, C18 unsatd., reaction products with sodium N-methyltaurinate",1471313-87-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f659e12-d070-4d02-9f30-efadd968a97a/documents/IUC5-8ccb59ae-fe6b-41aa-8963-7d206ee24151_74d51ac8-211f-44bc-ab48-b2bba68d6c98.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acid chlorides, C18 unsatd., reaction products with sodium N-methyltaurinate",1471313-87-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f659e12-d070-4d02-9f30-efadd968a97a/documents/IUC5-8ccb59ae-fe6b-41aa-8963-7d206ee24151_74d51ac8-211f-44bc-ab48-b2bba68d6c98.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids C18 unsat, reaction products with Pentaethylenehexamine",1224966-13-5,"A combined repeated dose/reproduction screening toxicity study according to OECD 422 with Fatty acid reaction product with pentaethylene-hexamine (AAI-PEHA) resulted to a NOAEL of 300 mg/kg bw/day being the highest tested dose level. All already available data from the group of Amidoamine/imidazolines AAI substances, including 90 -day studies in rat and dogs on a similar substance, also indicate low repeated dose toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d7916d0-4096-4dee-a3b2-55b4f66688cc/documents/IUC5-187204c7-1178-41da-b6a4-92c859a79b53_466ede27-6341-445e-9d2f-8a297a5887ec.html,,,,,, "Fatty acids C18 unsat, reaction products with Pentaethylenehexamine",1224966-13-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d7916d0-4096-4dee-a3b2-55b4f66688cc/documents/IUC5-187204c7-1178-41da-b6a4-92c859a79b53_466ede27-6341-445e-9d2f-8a297a5887ec.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Fatty acids C18 unsat, reaction products with Pentaethylenehexamine",1224966-13-5,Acute toxicity: Oral LD50 > 2000 mg/kg for rat. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d7916d0-4096-4dee-a3b2-55b4f66688cc/documents/IUC5-e4b779e3-0dae-40d6-9dba-dc31fb2a40c5_466ede27-6341-445e-9d2f-8a297a5887ec.html,,,,,, "Fatty acids C18 unsat, reaction products with Pentaethylenehexamine",1224966-13-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d7916d0-4096-4dee-a3b2-55b4f66688cc/documents/IUC5-e4b779e3-0dae-40d6-9dba-dc31fb2a40c5_466ede27-6341-445e-9d2f-8a297a5887ec.html,,oral,LD50,"2,500 mg/kg bw",, "Fatty acids C18 unsat, reaction products with tetraethylenepentamine",1226892-45-0," A combined repeated dose/reproduction screening toxicity study according to OECD 422 with Fatty acid reaction products with tetraethylene-pentamine (FA-TEPA) resulted to a NOAEL of 300 mg/kg bw/day being the highest tested dose level. All already available data from the group of Amidoamine/imidazolines (AAI) substances, including 90-day studies in rat and dogs on similar substances, also indicate low repeated dose toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2293ec2a-be38-4a18-89f5-923ccd3b3a45/documents/IUC5-56c25484-418c-47d1-8d36-8f60f90f2931_2b887840-b9c9-49b4-8ec3-2172a87c632c.html,,,,,, "Fatty acids C18 unsat, reaction products with tetraethylenepentamine",1226892-45-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2293ec2a-be38-4a18-89f5-923ccd3b3a45/documents/IUC5-56c25484-418c-47d1-8d36-8f60f90f2931_2b887840-b9c9-49b4-8ec3-2172a87c632c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Fatty acids C18 unsat, reaction products with tetraethylenepentamine",1226892-45-0, Acute toxicity: Oral LD50 > 2000 mg/kg for rat (LD50 cut-off: 2500 mg/kg bw) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2293ec2a-be38-4a18-89f5-923ccd3b3a45/documents/IUC5-043423c2-29f4-4356-bf4f-43f92e97072f_2b887840-b9c9-49b4-8ec3-2172a87c632c.html,,,,,, "Fatty acids C18 unsat, reaction products with tetraethylenepentamine",1226892-45-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2293ec2a-be38-4a18-89f5-923ccd3b3a45/documents/IUC5-043423c2-29f4-4356-bf4f-43f92e97072f_2b887840-b9c9-49b4-8ec3-2172a87c632c.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, "Fatty acids C18 unsat, reaction products with triethylenetetramine",1226892-44-9," No data on acute toxicity is available for""Fatty acids C18 unsat, reaction products with triethylenetetramine"" (or TO + TETA). Read-across is performed with ""Fatty acids C18 unsat, reaction products with diethylenetetramine"" (or TO + DETA). A combined repeated dose/reproduction screening toxicity study according to OECD 422 with Fatty acids, C18 unsat, reaction products with diethylenetriamine (AAI-DETA) resulted to a NOAEL of 10 mg/kg bw/day based on the increased incidence/severity of macrophage foci in the mesenteric lymph node observed at 30 or 100 mg/kg bw/day, the highest dose tested. All already available data from the group of AAI substances, including 90 -day studies in rat and dogs on a similar substance, also indicate low repeated dose toxicity. The 90-day NOAEL with AAI-DETA is considered to be 10 mg/kg bw/d. At higher dose levels an increase of the presence of foamy macrophages in the lamina propria of the small intestines and mesenteric lymph nodes is observed, as well as lower mean body weight and body weight gain, especially in the males, with lower food intake, essentially during the second half of the treatment period. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d01d5d53-bdc5-4437-b304-3e35efdc2ae6/documents/7f35f93d-1b32-437f-913b-3a3fffc6a5e2_24ada96f-abb6-4ff2-8ae6-e3c4a1b805d9.html,,,,,, "Fatty acids C18 unsat, reaction products with triethylenetetramine",1226892-44-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d01d5d53-bdc5-4437-b304-3e35efdc2ae6/documents/7f35f93d-1b32-437f-913b-3a3fffc6a5e2_24ada96f-abb6-4ff2-8ae6-e3c4a1b805d9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "Fatty acids C18 unsat, reaction products with triethylenetetramine",1226892-44-9," No data on acute toxicity is available for""Fatty acids C18 unsat, reaction products with triethylenetetramine"" (or TO + TETA). Read-across is performed with """"Fatty acids C18 unsat, reaction products with diethylenetetramine"" (or TO + DETA). Acute Oral Toxicity LD50 > 2000 mg/kg for rat (LD50 cut-off: 2500 mg/kg bw). No acute dermal and inhalation toxicity studies were performed on the substance due to its corrosive properties. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d01d5d53-bdc5-4437-b304-3e35efdc2ae6/documents/aa167448-13bd-4a38-b721-7cc09d856fb5_24ada96f-abb6-4ff2-8ae6-e3c4a1b805d9.html,,,,,, "Fatty acids C18 unsat, reaction products with triethylenetetramine",1226892-44-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d01d5d53-bdc5-4437-b304-3e35efdc2ae6/documents/aa167448-13bd-4a38-b721-7cc09d856fb5_24ada96f-abb6-4ff2-8ae6-e3c4a1b805d9.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, "Fatty acids, C10-12, esters with polylactic acid, sodium salts",1312021-45-6," Short-term (28-day), oral (OECD 407): NOAEL (rat, m/f) = 750 mg/kg bw/day (highest dose tested) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/595f0e54-6a77-4daa-afc1-d6cb60334aff/documents/e61a3f52-5e05-40e8-ba2f-4ab421f43dc5_c8d3a7c0-17ca-4cb5-890e-94547c779d3b.html,,,,,, "Fatty acids, C10-12, esters with polylactic acid, sodium salts",1312021-45-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/595f0e54-6a77-4daa-afc1-d6cb60334aff/documents/e61a3f52-5e05-40e8-ba2f-4ab421f43dc5_c8d3a7c0-17ca-4cb5-890e-94547c779d3b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Fatty acids, C10-12, esters with polylactic acid, sodium salts",1312021-45-6," Oral: Calculated LD50 (rat) = 4880 mg/kg bw Weight-of-Evidence approach based on data for structural similar substances, publically available information on food additives, results of a short-term repeated dose toxicity study and a reproductive/developmental toxicity screening test with the registered substance. Inhalation: No study required as the inhalation route of exposure is considered less relevant than the dermal route. Dermal: According to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, no study is required as fatty acids, C10-12, esters with polylactic acid, sodium salts (Dermosoft decalact, CAS No. 1312021-45-6, EC No. 700-937-1) does not meet the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/595f0e54-6a77-4daa-afc1-d6cb60334aff/documents/6a01a828-bf3c-4b89-87a1-1d7e7896a52a_c8d3a7c0-17ca-4cb5-890e-94547c779d3b.html,,,,,, "Fatty acids, C10-18 and C12-22-unsatd., C14-18 and C16-18-unsatd. alkyl esters",85049-31-6,NOAEL subcronic toxicity rat = 1000 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ff6b89a-840e-4358-9fb0-2fc7462e0686/documents/IUC5-780fd098-9014-44f3-b87d-3a31cc85ffbc_81218001-5956-4e8e-8858-6197ff193a72.html,,,,,, "Fatty acids, C10-18 and C12-22-unsatd., C14-18 and C16-18-unsatd. alkyl esters",85049-31-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ff6b89a-840e-4358-9fb0-2fc7462e0686/documents/IUC5-780fd098-9014-44f3-b87d-3a31cc85ffbc_81218001-5956-4e8e-8858-6197ff193a72.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C10-18 and C12-22-unsatd., C14-18 and C16-18-unsatd. alkyl esters",85049-31-6,Non toxicLD50 oral rat > 5000LD50 dermal rabbit > 2000 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ff6b89a-840e-4358-9fb0-2fc7462e0686/documents/IUC5-e701b7dd-d7f5-4cac-83d2-d6c9713d369c_81218001-5956-4e8e-8858-6197ff193a72.html,,,,,, "Fatty acids, C10-20-neo-",85116-96-7,Repeated exposure may cause skin dryness or cracking. No systemic toxicity is observed. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3066e04c-ac01-4dd1-a10a-49f4fc6bce6d/documents/c73354a8-c989-4c2f-9417-36e8ded2c8a8_f0d692a9-e112-45c2-852d-b25b1eed4608.html,,,,,, "Fatty acids, C10-20-neo-",85116-96-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3066e04c-ac01-4dd1-a10a-49f4fc6bce6d/documents/c73354a8-c989-4c2f-9417-36e8ded2c8a8_f0d692a9-e112-45c2-852d-b25b1eed4608.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,, "Fatty acids, C10-30, esters with lanolin alcs.",97862-72-1," Albino rats in groups of ten (5M:5F), weighing between 150 and 300 g, were dosed with 5000 mg/kg lanolin fatty acids once using an oral method, and observed for fourteen days (Lewis 1977). The LD50 of the test material has been determined to be greater than 5 g/kg/bw. A study to determine the oral toxicity of Lanolin alcohols was conducted following the OECD Guidelne 401 and EC guideline B1 (Leuschner 2001). Under the test conditions (a single oral dose of the test material at 2000 mg/kg bw) to rats revealed no toxic symptoms. The LD50 is > 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fa024bf-1671-4e34-a44d-225e57c0dc63/documents/e994abca-e75e-4e92-bc1c-c539c65fa340_26f28a90-7a00-44c7-aade-9ef3853ad199.html,,,,,, "Fatty acids, C10-30, esters with lanolin alcs.",97862-72-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fa024bf-1671-4e34-a44d-225e57c0dc63/documents/e994abca-e75e-4e92-bc1c-c539c65fa340_26f28a90-7a00-44c7-aade-9ef3853ad199.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C12-14",90990-10-6,"Reliable studies on oral repeated dose toxicity are available for the following category members:Subchronic: NOAEL oral = ca. 5000 mg/kg bw/d; CAS# 143-07-7, C12 (Fitzhugh 1960)Subchronic: NOAEL oral = 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao 2002)No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04384b3e-c3ff-47f8-b0b5-fe181d2edcb2/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_7a137992-bce7-44e9-8aaf-1631f5f15384.html,,,,,, "Fatty acids, C12-14",90990-10-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04384b3e-c3ff-47f8-b0b5-fe181d2edcb2/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_7a137992-bce7-44e9-8aaf-1631f5f15384.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C12-14",90990-10-6,"Acute Toxicity:- oral: LD50 >5000 mg/kg bw (OECD 401; Analogy CAS 143-07-7, CAS 544-63-8);- inhalative: LC50 >0.1521 mg/L (IHT; Analogy CAS 124-07-2)- dermal: LD50 >2000 mg/kg bw (Analogy CAS 57-11-4) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04384b3e-c3ff-47f8-b0b5-fe181d2edcb2/documents/IUC5-71ce6206-c65e-4bd2-81ec-8c1436cd3f63_7a137992-bce7-44e9-8aaf-1631f5f15384.html,,,,,, "Fatty acids, C12-14 (even numbered), methyl ester",308065-15-8,"All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air.While no reliable acute dermal toxicity studies are available., the picture of all available data is consistent supporting also a low level of dermal toxicity for the category of fatty acid methyl esters. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78a014c2-6451-4cc8-8406-e7f080c73b78/documents/ae939af8-1bae-45ce-936e-201c1c219aef_5744d748-5314-4991-95b1-9979b3c5d352.html,,,,,, "Fatty acids, C12-16 (even numbered) and C18 unsatd., Me esters",1234694-02-0,"All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air.While no reliable acute dermal toxicity studies are available., the picture of all available data is consistent supporting also a low level of dermal toxicity for the category of fatty acid methyl esters. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cffde93c-3b05-4ad8-98c8-4857c51fb1f7/documents/796fea7b-9062-4aad-a978-c91ec1dba06a_f33e114f-e822-4a8d-a838-a314cf8f846b.html,,,,,, "Fatty acids, C12-16, esters with neopentyl glycol",85186-95-4,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object showing an overview of the strategy for all substances within the polyol esters category. All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5 mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb9714a9-8066-48ea-b7e7-5a97d908a58a/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_87bc212c-90c3-47d9-896a-7856fff0388e.html,,,,,, "Fatty acids, C12-16, esters with neopentyl glycol",85186-95-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb9714a9-8066-48ea-b7e7-5a97d908a58a/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_87bc212c-90c3-47d9-896a-7856fff0388e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, "Fatty acids, C12-16, esters with neopentyl glycol",85186-95-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb9714a9-8066-48ea-b7e7-5a97d908a58a/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_87bc212c-90c3-47d9-896a-7856fff0388e.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",, "Fatty acids, C12-16, esters with neopentyl glycol",85186-95-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb9714a9-8066-48ea-b7e7-5a97d908a58a/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_87bc212c-90c3-47d9-896a-7856fff0388e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.5 mg/L,, "Fatty acids, C12-16, esters with neopentyl glycol",85186-95-4,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object showing an overview of the strategy for all substances within the polyol esters category.All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb9714a9-8066-48ea-b7e7-5a97d908a58a/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_87bc212c-90c3-47d9-896a-7856fff0388e.html,,,,,, "Fatty acids, C12-18",67701-01-3,"Reliable studies on oral repeated dose toxicity are available for the following category members:Subchronic: NOAEL oral = ca. 5000 mg/kg bw/d; CAS# 143-07-7, C12 (Fitzhugh 1960)Subchronic: NOAEL oral = 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao 2002)No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be79acdd-c9dc-403b-8780-de5d3489e4f9/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_1171c175-9c68-400d-be13-4c8855d7c404.html,,,,,, "Fatty acids, C12-18",67701-01-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be79acdd-c9dc-403b-8780-de5d3489e4f9/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_1171c175-9c68-400d-be13-4c8855d7c404.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C12-18",67701-01-3,"Acute toxicity:- oral: LD50 >5000 mg/kg bw (OECD 401; Analogy CAS 143-07-7, CAS 57-10-3, CAS 57-11-4 );- inhalative: LC50 >0.1521 mg/L (IHT; Analogy CAS 124-07-2);- dermal: LD50 > 2000 mg/kg bw (Analogy CAS 57-11-4); ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be79acdd-c9dc-403b-8780-de5d3489e4f9/documents/IUC5-8cacc3c3-1462-4636-8431-254b9141df5a_1171c175-9c68-400d-be13-4c8855d7c404.html,,,,,, "Fatty acids, C14-18 and C16-18 unsatd., compds. with triethanolamine",68082-25-7," In a OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) by oral route, no treatment related effects were observed up the maximum dose tested. NOAEL >= 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f909d0f-2f04-4d6d-9661-6dfbfa19059b/documents/f75fbcca-ee72-4085-ba2c-d008e6623cbb_c3d77354-d03a-484d-9ff2-7f815e44c955.html,,,,,, "Fatty acids, C14-18 and C16-18 unsatd., compds. with triethanolamine",68082-25-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f909d0f-2f04-4d6d-9661-6dfbfa19059b/documents/f75fbcca-ee72-4085-ba2c-d008e6623cbb_c3d77354-d03a-484d-9ff2-7f815e44c955.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C14-18 and C16-18-unsatd.",67701-06-8,"Reliable studies on oral repeated dose toxicity are available for the following category members:Subchronic: NOAEL oral = ca. 5000 mg/kg bw/d; CAS# 143-07-7, C12 (Fitzhugh 1960)Subchronic: NOAEL oral = 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao 2002)No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4fc67dea-ffa8-4cb9-863f-14e76dc37023/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_2d03dd46-c44b-44ca-bee5-3453cb6d4730.html,,,,,, "Fatty acids, C14-18 and C16-18-unsatd.",67701-06-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4fc67dea-ffa8-4cb9-863f-14e76dc37023/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_2d03dd46-c44b-44ca-bee5-3453cb6d4730.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C14-18 and C16-18-unsatd.",67701-06-8,Acute Toxicity:- oral: LD50 >2000 mg/kg bw (OECD 401);- inhalative: LC50 >0.1521 mg/L (IHT; Analogy CAS 124-07-2)- dermal: LD50 >2000 mg/kg bw (Analogy CAS 57-11-4) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fc67dea-ffa8-4cb9-863f-14e76dc37023/documents/IUC5-c3722683-2034-49d7-bada-481c89bf3c69_2d03dd46-c44b-44ca-bee5-3453cb6d4730.html,,,,,, "Fatty acids, C14-18 and C16-18-unsatd., ammonium salts",68604-33-1," The analogue substance 9-octadecenoic acid caused changes in the epidermis, the corium and in hair follicles after repeated applications to the skin of rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4cae419e-2bba-42a9-860b-e4c6447058db/documents/81fcd1ad-18c2-4bd1-96df-84f02f5be280_b189d574-f049-471c-b90e-839ba85b00da.html,,,,,, "Fatty acids, C14-18 and C16-18-unsatd., ammonium salts",68604-33-1," oral: Based on read across studies for acute oral toxicity on chemically similar substances, the LD50(oral) for Fatty acids, C14-18 and C16-18-unsatd., ammonium salts is estimated to be >5000 mg/kg. dermal: Based on read across studies for acute dermal toxicity on chemically similar substances and the weight of evidence approach, the LD50(dermal) for Fatty acids, C14-18 and C16-18-unsatd., ammonium salts is estimated to be >5000 mg/kg. inhalation - vapours: Based on the low acute oral toxicity (LD50(oral): >5000mg/kg) and the tiny vapour pressure (Vapour pressure(25°C): <0.01 Pa) of Fatty acids, C14-18 and C16-18-unsatd., ammonium salts, no acute inhalation toxicity of a at 25°C saturated atmosphere of vapours of this substances is expected. inhalation - dust/mist: data lacking; (Based on the intended use of the products containing Fatty acids, C14-18 and C16-18-unsatd., ammonium salts, exposition to dust/mist of this substance are not expected.). intravenous: After intravenous application, a LD50 of approximately 267 mg/kg bw was determined for a analogue substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4cae419e-2bba-42a9-860b-e4c6447058db/documents/dc9da1ad-a910-4bff-981d-afcce7fed162_b189d574-f049-471c-b90e-839ba85b00da.html,,,,,, "Fatty acids, C14-18 and C16-18-unsatd., ammonium salts",68604-33-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4cae419e-2bba-42a9-860b-e4c6447058db/documents/dc9da1ad-a910-4bff-981d-afcce7fed162_b189d574-f049-471c-b90e-839ba85b00da.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Fatty acids, C14-18 and C16-18-unsatd., ammonium salts",68604-33-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4cae419e-2bba-42a9-860b-e4c6447058db/documents/dc9da1ad-a910-4bff-981d-afcce7fed162_b189d574-f049-471c-b90e-839ba85b00da.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Fatty acids, C14-18 and C16-18-unsatd., barium salts",95465-85-3,"Fatty acids, C14-18 and C16-18, unsatd. barium salts is not expected to show acute toxic effects via dermal route. The calculated oral ATE for fatty acids, C14-18 and C16-18, unsatd. barium salts is 424, taking into account the ATE values of the individual constituents given in the table above and the maximum barium content of 22% and the maximum fatty acids, C14-18 and C16-18, unsatd. content of 78% in fatty acids, C14-18 and C16-18, unsatd. barium salts. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dafd0b9d-2621-4461-90c2-07fd0383a92c/documents/IUC5-55283da8-d0b9-4158-8568-f8074f2b59f2_5fef2049-3f3c-4b33-92f5-96e525fa5561.html,,,,,, "Fatty acids, C14-18 and C16-18-unsatd., barium salts",95465-85-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dafd0b9d-2621-4461-90c2-07fd0383a92c/documents/IUC5-55283da8-d0b9-4158-8568-f8074f2b59f2_5fef2049-3f3c-4b33-92f5-96e525fa5561.html,,oral,LD50,424 mg/kg bw,adverse effect observed, "Fatty acids, C14-18 and C16-18-unsatd., esters with neopentyl glycol",85116-81-0,All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e49d6aa2-b256-4ea1-b929-a20bff575826/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_d7b35ecb-a879-4589-9d76-7459df982cc8.html,,,,,, "Fatty acids, C14-18 and C16-18-unsatd., esters with neopentyl glycol",85116-81-0,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e49d6aa2-b256-4ea1-b929-a20bff575826/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_d7b35ecb-a879-4589-9d76-7459df982cc8.html,,,,,, "Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol",84988-75-0,"Oral (subacute, OECD 422, GLP, rat, m/f): NOAEL (systemic toxicity) ≥ 1000 mg/kg bw/day Conclusion based on data obtained with fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol (EC 284-864-6, CAS 84988-75-0).   Oral (subchronic): NOAEL (systemic toxicity) ≥ 1000 mg/kg bw/day Read-across based on grouping of substances (category approach) considering all available data on subacute and subchronic repeated dose toxicity in the propylene glycol esters category in a weight of evidence approach. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b939fa33-c65f-4521-aaba-18d3c14607dd/documents/IUC5-9940a6cc-dfa0-4a25-98b5-eb4c9c5b08d4_72d23315-de10-4c7c-aa8e-efe75477a5eb.html,,,,,, "Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol",84988-75-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b939fa33-c65f-4521-aaba-18d3c14607dd/documents/IUC5-9940a6cc-dfa0-4a25-98b5-eb4c9c5b08d4_72d23315-de10-4c7c-aa8e-efe75477a5eb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat "Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol",84988-75-0,"Oral LD50 (OECD 423, GLP, rat) > 2000 mg/kg bw Conclusion based on data with fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol (EC 284-864-6, CAS 84988-75-0). Inhalation No information is required according to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, as data on acute oral toxicity are provided and the oral and dermal route are considered more relevant. Dermal No information is required according to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5.2, Column 2, as the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure performed with propylene glycol esters category substances. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b939fa33-c65f-4521-aaba-18d3c14607dd/documents/IUC5-343ce3af-a0b7-4460-abc0-fe073e54ac78_72d23315-de10-4c7c-aa8e-efe75477a5eb.html,,,,,, "Fatty acids, C14-18 and C16-18-unsatd., esters with propylene glycol",84988-75-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b939fa33-c65f-4521-aaba-18d3c14607dd/documents/IUC5-343ce3af-a0b7-4460-abc0-fe073e54ac78_72d23315-de10-4c7c-aa8e-efe75477a5eb.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C14-18 and C16-18-unsatd., isotridecyl esters",85116-88-7,NOAEL systemic= 300 mg/kg bw/day ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/2345beb0-cbe1-4104-9c69-8e26795779d4/documents/IUC5-5ebc1a53-527b-484d-b6cf-fd1242616a5d_6476daf6-89f6-4d54-80f1-64b056292865.html,,,,,, "Fatty acids, C14-18 and C16-18-unsatd., isotridecyl esters",85116-88-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/2345beb0-cbe1-4104-9c69-8e26795779d4/documents/IUC5-5ebc1a53-527b-484d-b6cf-fd1242616a5d_6476daf6-89f6-4d54-80f1-64b056292865.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Fatty acids, C14-18 and C16-18-unsatd., isotridecyl esters",85116-88-7,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2345beb0-cbe1-4104-9c69-8e26795779d4/documents/IUC5-b978fe4c-1f67-4f16-bed5-0f50fbcbb1bd_6476daf6-89f6-4d54-80f1-64b056292865.html,,,,,, "Fatty acids, C14-18 and C16-18-unsatd., Me esters",67762-26-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a6e68e8-367d-45a6-a270-a0015fbbdb94/documents/IUC5-560535ec-13cd-4e69-a17f-9b4b203eeda1_b1b4a7bd-65d9-4668-8473-4ca24d471143.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C14-18 and C16-18-unsatd., Me esters",67762-26-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a6e68e8-367d-45a6-a270-a0015fbbdb94/documents/IUC5-8692fe50-bc25-44d8-8036-6b4be022a40f_b1b4a7bd-65d9-4668-8473-4ca24d471143.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Fatty acids, C14-18 and C16-18-unsatd., Me esters",67762-26-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a6e68e8-367d-45a6-a270-a0015fbbdb94/documents/IUC5-8692fe50-bc25-44d8-8036-6b4be022a40f_b1b4a7bd-65d9-4668-8473-4ca24d471143.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol",92113-48-9,"Repeated dose toxicity: via oral route: NOAEL = 1000 mg/kg bw/day (OECD 422, GLP, K, Rel.1) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/adf62db5-096b-4419-9bb9-3dfb80bead73/documents/IUC5-aaefeef8-a783-4d6a-a58b-158de13e82ff_bd6e33ee-10d0-4ca9-a1a5-e7d484230aac.html,,,,,, "Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol",92113-48-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/adf62db5-096b-4419-9bb9-3dfb80bead73/documents/IUC5-aaefeef8-a783-4d6a-a58b-158de13e82ff_bd6e33ee-10d0-4ca9-a1a5-e7d484230aac.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol",92113-48-9,"Acute Oral: LD50 (rat, m/f) > 2000 mg/kg bw (OECD 423, GLP, K, rel.1)Acute Inhalation: LC50 (rat, m/f) > 5 mg/L (aerosol) (OECD 436, GLP, K, rel.1)Acute Dermal: no study available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/adf62db5-096b-4419-9bb9-3dfb80bead73/documents/IUC5-ece82dad-cdba-492c-9920-530bca22539c_bd6e33ee-10d0-4ca9-a1a5-e7d484230aac.html,,,,,, "Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol",92113-48-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/adf62db5-096b-4419-9bb9-3dfb80bead73/documents/IUC5-ece82dad-cdba-492c-9920-530bca22539c_bd6e33ee-10d0-4ca9-a1a5-e7d484230aac.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C14-18 and C16-18-unsatd., mixed esters with castor oil, castor oil fatty acids, 2-ethylhexanoic acid and 2,2-bis(hydroxymethyl)-1-butanol",92113-48-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/adf62db5-096b-4419-9bb9-3dfb80bead73/documents/IUC5-ece82dad-cdba-492c-9920-530bca22539c_bd6e33ee-10d0-4ca9-a1a5-e7d484230aac.html,,inhalation,LC50,> 5 mg/L,no adverse effect observed, "Fatty acids, C14-18 and C16-18-unsatd., zinc salts",67701-12-6," No repeated dose toxicity study with Fatty acids, C14 -18 and C16 -18 unsatd., zinc salts is available, thus the repeated dose toxicity will be addressed with existing data on the moieties liberated upon dissolution, zinc and fatty acid, C14 -18 and C16 -18 unsatd. In relevant and reliable repeated dose toxicity studies for the moiety zinc of Fatty acids, C14 -18 and C16 -18 unsatd., zinc salts, and in peer-reviewed publicly available assessment reports for the assessment entity fatty acids, C14 -18 and C16 -18 unsatd, there were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cba5f3a7-0f49-41c5-82ac-bbabdc2b94e2/documents/IUC5-f5e00926-3d0c-412d-b4e2-0d29d291bc85_a5209944-dcc2-4b34-ab22-ac1afdf6f886.html,,,,,, "Fatty acids, C14-18 and C16-18-unsatd., zinc salts",67701-12-6," No acute toxicity studies with Fatty acids, C14 -18 and C16 -18 unsatd., zinc salts are available, thus the acute toxicity will be addressed with existing data on the dissociation products zinc and fatty acids, C14 -18 and C16 -18 unsatd. and with existing data on structurally similar or shorter-chained zinc salts of fatty acids.   Signs of acute oral, inhalation and dermal toxicity are not expected for Fatty acids, C14 -18 and C16 -18 unsatd., zinc salts, since no acute oral, dermal or inhalation toxicity was observed in reliable studies with the strucurally similar substance Fatty acids, C16 -18, zinc salts and shorter-chained zinc salts of fatty acids. Moreover, the moiety zinc has not shown signs of acute oral or inhalation toxicity in experimental testing and the acute dermal toxicity for the moiety zinc can be considered low in view of the poor absorption by this route. For the moiety fatty acids, C14 -18 and C16 -18 unsatd. there were no toxicological findings reported in peer-reviewed publicly available assessment reports, neither by the oral nor by the dermal route.   The calculated oral and dermal LD50 for fatty acids, C14 -18 and C16 -18 unsatd., zinc salts is > 2000mg/kg and the LC50 is expected to be higher than 50 mg/L based experimental data available with Fatty acids, C16 -18, zinc salts. Hence the substance is not to be classified according to regulation (EC) 1272/2008 and its subsequent amendments for acute oral, inhalation and dermal toxicity as well as for specific target organ toxicity, single exposure (STOT SE). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cba5f3a7-0f49-41c5-82ac-bbabdc2b94e2/documents/IUC5-0c5e8daa-69a8-44a0-b42f-8c367dcb37df_a5209944-dcc2-4b34-ab22-ac1afdf6f886.html,,,,,, "Fatty acids, C14-18 and C16-18-unsatd., zinc salts",67701-12-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cba5f3a7-0f49-41c5-82ac-bbabdc2b94e2/documents/IUC5-0c5e8daa-69a8-44a0-b42f-8c367dcb37df_a5209944-dcc2-4b34-ab22-ac1afdf6f886.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C14-18 and C16-18-unsatd., zinc salts",67701-12-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cba5f3a7-0f49-41c5-82ac-bbabdc2b94e2/documents/IUC5-0c5e8daa-69a8-44a0-b42f-8c367dcb37df_a5209944-dcc2-4b34-ab22-ac1afdf6f886.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C14-18 and C16-18-unsatd., zinc salts",67701-12-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cba5f3a7-0f49-41c5-82ac-bbabdc2b94e2/documents/IUC5-0c5e8daa-69a8-44a0-b42f-8c367dcb37df_a5209944-dcc2-4b34-ab22-ac1afdf6f886.html,,inhalation,LC50,"50,000 mg/m3",no adverse effect observed, "Fatty acids, C14-18 and C18-unsatd., branched and linear, 2-ethylhexyl esters",85186-76-1," According to the results of the studies performed on differents substances which belong to LCAE category, a No Observed Adverse Effect Level can be derived for the registered substance, the 2-ethyl hexyl isostearate, at 1000 mg/kg bw/day for rats. No adverse effect or toxicity was observed on the studies, the substance was not classified for STOT-RE according to CLP regulation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6722bcd3-fe94-441c-b1b2-cad05e68312f/documents/d408361a-b3dd-4656-9478-1a906ca81330_3ab07c89-23ca-4ab7-a4d0-5052ca2bd3d0.html,,,,,, "Fatty acids, C14-18 and C18-unsatd., branched and linear, 2-ethylhexyl esters",85186-76-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6722bcd3-fe94-441c-b1b2-cad05e68312f/documents/d408361a-b3dd-4656-9478-1a906ca81330_3ab07c89-23ca-4ab7-a4d0-5052ca2bd3d0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C14-18 and C18-unsatd., branched and linear, 2-ethylhexyl esters",85186-76-1," Using a Read Across Category approach with Long Chain Acid Esters substances (C8 to C18) according to the Annex XI Item 1.5, of Regulation (EC) No 1907/2006, all available acute oral toxicity studies within this category resulted in an acute oral Lethal Dose 50 (LD50) value higher than 2000 mg/kg bw (oral exposure) and LC50 was defined at higher than 5.7 mg/L (inhalation exposure). Hence, according to the CLP criteria, the test item Isostearate Ethyl Hexyl was not classified for acute oral hazard (or Category 5 according to GHS criteria) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6722bcd3-fe94-441c-b1b2-cad05e68312f/documents/9080b2cb-8285-4a60-8086-e0284060a871_3ab07c89-23ca-4ab7-a4d0-5052ca2bd3d0.html,,,,,, "Fatty acids, C14-18 and C18-unsatd., branched and linear, 2-ethylhexyl esters",85186-76-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6722bcd3-fe94-441c-b1b2-cad05e68312f/documents/9080b2cb-8285-4a60-8086-e0284060a871_3ab07c89-23ca-4ab7-a4d0-5052ca2bd3d0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C14-18 and C18-unsatd., branched and linear, 2-ethylhexyl esters",85186-76-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6722bcd3-fe94-441c-b1b2-cad05e68312f/documents/9080b2cb-8285-4a60-8086-e0284060a871_3ab07c89-23ca-4ab7-a4d0-5052ca2bd3d0.html,,inhalation,LC50,"5,700 mg/m3",no adverse effect observed, "Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with neopentyl glycol",85005-25-0,All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f18a1a3-34cd-422e-8fba-09c0f51a865c/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_a2415c5e-3ebf-4610-a4d6-a732e650cbd7.html,,,,,, "Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with neopentyl glycol",85005-25-0,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f18a1a3-34cd-422e-8fba-09c0f51a865c/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_a2415c5e-3ebf-4610-a4d6-a732e650cbd7.html,,,,,, "Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with pentaerythritol",85186-72-7,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.   RDT (oral, OECD 407), rat: NOAEL (m/f) = 1450/1613 mg/kg bw/day (RA from CAS 68424-31-7) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study (Klimisch score 1) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products, similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.6, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fbe7d37-b0b5-4827-a4e7-a0d8fb5161e9/documents/IUC5-b7dade19-ca41-4be1-9018-cd5c93c7d38a_3c479a57-d51d-4a14-9ac9-7a92a10425b3.html,,,,,, "Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with pentaerythritol",85186-72-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fbe7d37-b0b5-4827-a4e7-a0d8fb5161e9/documents/IUC5-b7dade19-ca41-4be1-9018-cd5c93c7d38a_3c479a57-d51d-4a14-9ac9-7a92a10425b3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,450 mg/kg bw/day",,rat "Fatty acids, C14-18 and C18-unsatd., branched and linear, esters with pentaerythritol",85186-72-7,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.   Oral (OECD 401/423), rat: LD50 >5000 mg/kg bw (RA from CAS 19321-40-5 and CAS 62125-22-8) Inhalation: Data waiving Dermal (OECD 402), rat: LD50 >2000 mg/kg bw (RA from CAS 62125-22-8) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate, reliable (Klimisch score 1 and 2) and consistent studies, from two reference substances with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products, similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details). The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study (Klimisch score 2 ) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products, similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5.3, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fbe7d37-b0b5-4827-a4e7-a0d8fb5161e9/documents/IUC5-db619939-e538-43de-8c08-b88a705f6cbf_3c479a57-d51d-4a14-9ac9-7a92a10425b3.html,,,,,, "Fatty acids, C14-18, C14-18-alkyl esters",85566-24-1,"Oral (OECD 408), rat: NOAEL ≥ 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfc321c8-eede-42b9-a990-ef39ae611802/documents/3db4f1bf-ff85-478e-aef9-726245eb1ddb_1167b4ad-4965-4db7-80a9-f73ddc42a147.html,,,,,, "Fatty acids, C14-18, C14-18-alkyl esters",85566-24-1,"Oral (OECD 401), rat: LD50 > 5000 mg/kg bw (limit test)Inhalation (OECD 436), rat: LC50 > 5.7 mg/L airDermal (OECD 402), rabbit: LD50 > 2000 mg/kg bw (limit test) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfc321c8-eede-42b9-a990-ef39ae611802/documents/add5a089-f581-4a93-bbcf-5b0181c77630_1167b4ad-4965-4db7-80a9-f73ddc42a147.html,,,,,, "Fatty acids, C14-22",68424-37-3,"Reliable studies on oral repeated dose toxicity are available for the following category members:Subchronic: NOAEL oral = ca. 5000 mg/kg bw/d; CAS# 143-07-7, C12 (Fitzhugh 1960)Subchronic: NOAEL oral = 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao 2002)No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/239a5adf-993a-4655-b3e4-3cef24e831e5/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_9d754372-9ccf-47f5-8ac4-1f7817019e83.html,,,,,, "Fatty acids, C14-22",68424-37-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/239a5adf-993a-4655-b3e4-3cef24e831e5/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_9d754372-9ccf-47f5-8ac4-1f7817019e83.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C14-22",68424-37-3,"Acute toxicity:- oral: LD50 >5000 mg/kg bw (OECD 401; Analogy CAS CAS 57-10-3, CAS 57-11-4, CAS 112-85-6 );- inhalative: LC50 >0.1521 mg/L (IHT; Analogy CAS 124-07-2);- dermal: LD50 > 2000 mg/kg bw (Analogy CAS 57-11-4); ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/239a5adf-993a-4655-b3e4-3cef24e831e5/documents/IUC5-bf4470e4-cf1f-4b07-a0f7-b407d4d09938_9d754372-9ccf-47f5-8ac4-1f7817019e83.html,,,,,, "Fatty acids, C14-22, 2-ethylhexyl esters, epoxidized",95370-96-0,"A Klimisch 1 OECD 408 has been performed and confirmed all effects were considered non-adverse due to the mild severity of their nature. Based on observation the no observed adverse effect level (NOAEL) was established at 1000 mg/kg/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch 1 (reliable without restriction) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9a756b5-58a1-47ac-9be4-14d445ba0c1b/documents/IUC5-8c52b89b-0ebe-467e-9674-92a83723463a_2bf9290f-75e0-4ed9-a35d-fc01a577264f.html,,,,,, "Fatty acids, C14-22, 2-ethylhexyl esters, epoxidized",95370-96-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9a756b5-58a1-47ac-9be4-14d445ba0c1b/documents/IUC5-8c52b89b-0ebe-467e-9674-92a83723463a_2bf9290f-75e0-4ed9-a35d-fc01a577264f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C14-22, 2-ethylhexyl esters, epoxidized",95370-96-0,"Read-across substances are of low acute toxicity by the oral route (rat) and dermal route (rabbit) and confirm no classification requirement under the CLP Regulation (EC) No. 1272/2008. A waiver for acute inhalation toxicity has been prepared in line with Column 2 of Annex VIII of the REACH Regulation, taking into account the acute oral and acute dermal toxicity studies and the likely route(s) of human exposure. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch K2 (reliable with restrictions) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch K2 (reliable with restrictions) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9a756b5-58a1-47ac-9be4-14d445ba0c1b/documents/IUC5-f9dd3160-bf33-4d76-8117-4b5dcf2c86fa_2bf9290f-75e0-4ed9-a35d-fc01a577264f.html,,,,,, "Fatty acids, C14-22, 2-ethylhexyl esters, epoxidized",95370-96-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9a756b5-58a1-47ac-9be4-14d445ba0c1b/documents/IUC5-f9dd3160-bf33-4d76-8117-4b5dcf2c86fa_2bf9290f-75e0-4ed9-a35d-fc01a577264f.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Fatty acids, C14-22, 2-ethylhexyl esters, epoxidized",95370-96-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9a756b5-58a1-47ac-9be4-14d445ba0c1b/documents/IUC5-f9dd3160-bf33-4d76-8117-4b5dcf2c86fa_2bf9290f-75e0-4ed9-a35d-fc01a577264f.html,,dermal,LD50,"20,000 mg/kg bw",no adverse effect observed, "Fatty acids, C14-22, C16-24-alkyl esters",92797-30-3," In the absence of data on repeated dose toxicity on target substance Fatty acids, C14-22, C16-24-alkyl esters an analogue read-across approach was conducted on suitable source substances: Oral: OECD 422, rat, NOAEL systemic ≥ 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d9b7be7-53d4-433d-b109-3316140ee9ec/documents/b8ee838a-3234-4eaa-bcbe-d0e32f21123b_714fded7-50c7-423b-a749-af7fa638524a.html,,,,,, "Fatty acids, C14-22, C16-24-alkyl esters",92797-30-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d9b7be7-53d4-433d-b109-3316140ee9ec/documents/b8ee838a-3234-4eaa-bcbe-d0e32f21123b_714fded7-50c7-423b-a749-af7fa638524a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C14-22, C16-24-alkyl esters",92797-30-3," In the absence of data on acute toxicity on target substance Fatty acids, C14-22, C16-24-alkyl esters an analogue read-across approach was conducted on suitable source substances: Oral (OECD 401), rat: LD50: > 20 mL/kg bw (corresponding to 17400 mg/kg bw based on a relative density of 0.87 g/cm³; limit test) Inhalation (OECD 436), rat: LC50: > 5.7 mg/mL air Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d9b7be7-53d4-433d-b109-3316140ee9ec/documents/50b2c52c-c5d5-4c6f-823a-642450ddacfc_714fded7-50c7-423b-a749-af7fa638524a.html,,,,,, "Fatty acids, C14-22, ethylene esters, bisulfited, sodium salts",85005-32-9," Key study: Test method according to OECD 422. GLP Study. Based on a read-across from an analogue substance, the NOAEL for ""Fatty acids, C14 -22, ethylene esters, bisulfited, sodium salts"" is 1000 mg/kg-bw/day for general systemic toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ca36fd3-97df-4364-868b-78c2d8466945/documents/85f118cb-0104-4b58-ad97-0b289ef708ee_dc40ee2c-458a-49a4-95ee-a4ce5cafe419.html,,,,,, "Fatty acids, C14-22, ethylene esters, bisulfited, sodium salts",85005-32-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ca36fd3-97df-4364-868b-78c2d8466945/documents/85f118cb-0104-4b58-ad97-0b289ef708ee_dc40ee2c-458a-49a4-95ee-a4ce5cafe419.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C14-22, ethylene esters, bisulfited, sodium salts",85005-32-9," Key study: Test method according to OECD 420. GLP study. Based on the read-across approach, the oral LD50 of the subtance was determined to be > 2000 mg/kg-bw. Key study: Test method according to OECD 402. GLP Study. Based on the read-across approach, the dermal LD50 of the subtance was determined to be > 2000 mg/kg-bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ca36fd3-97df-4364-868b-78c2d8466945/documents/d72b4f68-65cf-444d-bf7d-3f2d5fa3832c_dc40ee2c-458a-49a4-95ee-a4ce5cafe419.html,,,,,, "Fatty acids, C14-22, ethylene esters, bisulfited, sodium salts",85005-32-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ca36fd3-97df-4364-868b-78c2d8466945/documents/d72b4f68-65cf-444d-bf7d-3f2d5fa3832c_dc40ee2c-458a-49a4-95ee-a4ce5cafe419.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C14-22, ethylene esters, bisulfited, sodium salts",85005-32-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ca36fd3-97df-4364-868b-78c2d8466945/documents/d72b4f68-65cf-444d-bf7d-3f2d5fa3832c_dc40ee2c-458a-49a4-95ee-a4ce5cafe419.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16 and C18-22-unsatd., C16-18 and C18-unsatd. alkyl esters",90990-29-7," Oral (similar to OECD 401), rat: LD50: > 20 mL/kg bw (corresponding to 17400 mg/kg bw based on a relative density of 0.87 g/cm³; limit test) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f66ad3c1-7391-4886-b2d0-ad433601c230/documents/12b356cd-dab0-4501-add8-e34684978d44_ea1204e5-e5a3-482b-8ca4-1e338a7eb55e.html,,,,,, "Fatty acids, C16 and C18-unsatd., polymers with bisphenol A, Bu glycidyl ether, epichlorohydrin and triethylenetetramine",105839-18-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/582120fc-7472-44b0-b931-709b7dfb01fe/documents/IUC5-ac98b420-0050-455e-b583-011b71c2725b_fdf5062d-11ca-40ed-ae98-2e9d22378796.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Fatty acids, C16 and C18-unsatd., polymers with bisphenol A, Bu glycidyl ether, epichlorohydrin and triethylenetetramine",105839-18-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/582120fc-7472-44b0-b931-709b7dfb01fe/documents/IUC5-83d710e6-f719-4e11-b93d-b0656fdae470_fdf5062d-11ca-40ed-ae98-2e9d22378796.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16 and C18-unsatd., polymers with bisphenol A, Bu glycidyl ether, epichlorohydrin and triethylenetetramine",105839-18-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/582120fc-7472-44b0-b931-709b7dfb01fe/documents/IUC5-83d710e6-f719-4e11-b93d-b0656fdae470_fdf5062d-11ca-40ed-ae98-2e9d22378796.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16 and C18-unsatd., triesters with trimethylolpropane",68424-27-1,All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3da266e3-1ece-4bbc-846c-132fa7ac1d80/documents/IUC5-3bee8ea8-9bb7-426f-b4e4-c21647768fee_8306155a-4f6b-434d-a482-50fb664c749e.html,,,,,, "Fatty acids, C16 and C18-unsatd., triesters with trimethylolpropane",68424-27-1,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3da266e3-1ece-4bbc-846c-132fa7ac1d80/documents/IUC5-c851a21c-3fff-4afd-9313-51003e688e88_8306155a-4f6b-434d-a482-50fb664c749e.html,,,,,, "Fatty acids, C16-18",67701-03-5," Reliable studies on oral repeated dose toxicity are available for the following category members: Subchronic: NOAEL oral = ca. 5000 mg/kg bw/d; CAS# 143-07-7, C12 (Fitzhugh 1960) Subchronic: NOAEL oral = 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao 2002) No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63928bb6-ddd1-48fd-858d-002d43e36ef7/documents/b62da58b-44b2-4d46-bcf5-d4c51a5a44df_94bb9bbb-0b21-4260-99ef-2aa549b5c5e3.html,,,,,, "Fatty acids, C16-18",67701-03-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63928bb6-ddd1-48fd-858d-002d43e36ef7/documents/b62da58b-44b2-4d46-bcf5-d4c51a5a44df_94bb9bbb-0b21-4260-99ef-2aa549b5c5e3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C16-18",67701-03-5,"Acute toxicity:- oral: LD50 >5000 mg/kg bw (OECD 401; Analogy CAS 57-10-3, CAS 57-11-4, CAS 112-85-6 );- inhalative: LC50 >0.1521 mg/L (IhT; Analogy CAS 124-07-2);- dermal: LD50 > 2000 mg/kg bw (Analogy CAS 57-11-4); ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63928bb6-ddd1-48fd-858d-002d43e36ef7/documents/IUC5-017458a1-6c65-4c0a-bf11-6846291fe3c3_94bb9bbb-0b21-4260-99ef-2aa549b5c5e3.html,,,,,, "Fatty acids, C16-18 and C18 unsatd., triesters with trimethylolpropane",68002-78-8,All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17920e1d-04cf-42ac-b3e3-c9c150540a4f/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_891f88de-8c61-4fa5-831f-31b7c961e1d2.html,,,,,, "Fatty acids, C16-18 and C18 unsatd., triesters with trimethylolpropane",68002-78-8,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17920e1d-04cf-42ac-b3e3-c9c150540a4f/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_891f88de-8c61-4fa5-831f-31b7c961e1d2.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., 2-ethylhexyl esters",85049-37-2,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d47316ba-5879-4eed-a277-0b234387693f/documents/IUC5-5988e75d-c243-4017-b573-242fcbaedde3_ed56c820-e7fa-4d10-9e09-9c8f0cbdc63e.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., 2-ethylhexyl esters",85049-37-2,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d47316ba-5879-4eed-a277-0b234387693f/documents/IUC5-b1e7c640-3939-4b69-a7b4-a7856a5e2d77_ed56c820-e7fa-4d10-9e09-9c8f0cbdc63e.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., branched and linear",68955-98-6,Based on read-across from a supporting substance (structural analogue) following a category approach:Oral: NOAEL (rat) = 741 (male) and 855 (female) mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/296ec6de-429d-4c8a-aab4-a31e40b8f822/documents/IUC5-1f8bfc83-c124-4c5d-9cb6-8a8c84224ac0_68fd779f-5728-46e0-8d31-2d5416bc7236.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., branched and linear",68955-98-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/296ec6de-429d-4c8a-aab4-a31e40b8f822/documents/IUC5-1f8bfc83-c124-4c5d-9cb6-8a8c84224ac0_68fd779f-5728-46e0-8d31-2d5416bc7236.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,741 mg/kg bw/day,,rat "Fatty acids, C16-18 and C18-unsatd., branched and linear",68955-98-6,Based on read-across following a category approach: Oral: LD50 (rat) > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/296ec6de-429d-4c8a-aab4-a31e40b8f822/documents/IUC5-db4e5603-4dd0-495b-8f54-d9bbc912019d_68fd779f-5728-46e0-8d31-2d5416bc7236.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., branched and linear",68955-98-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/296ec6de-429d-4c8a-aab4-a31e40b8f822/documents/IUC5-db4e5603-4dd0-495b-8f54-d9bbc912019d_68fd779f-5728-46e0-8d31-2d5416bc7236.html,,oral,LD50,"2,000 mg/kg bw",, "Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates",1393571-42-0,"Twelve rats/sex were treated with the test substance (oral gavage) at 0, 100, 300 and 1000 mg/kg bw during 14 days (pre-mating), during mating and 14 days thereafter (males). Females were further treated during gestation and until 5 days post-partum. No adverse effects on mortality, clinical and functional observations, body weight, food and water consumption, haematology and clinical chemistry, macroscopy, organ weights and histopatology were found. Incidental findings reported were within historical control values and without a dose-response relationship. Therefore the NOAEL is considered 1000 mg/kg bw ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/010f343d-2135-4216-85da-964bef5cdfaa/documents/IUC5-fdd610e6-19af-41a6-a210-6947d64db0ca_4767a283-b267-4718-bb8d-774429a6f44c.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates",1393571-42-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/010f343d-2135-4216-85da-964bef5cdfaa/documents/IUC5-fdd610e6-19af-41a6-a210-6947d64db0ca_4767a283-b267-4718-bb8d-774429a6f44c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates",1393571-42-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/010f343d-2135-4216-85da-964bef5cdfaa/documents/IUC5-fdd610e6-19af-41a6-a210-6947d64db0ca_4767a283-b267-4718-bb8d-774429a6f44c.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates",1393571-42-0,"Female rats (n=5) received a single oral dose of 2000 mg/kg bw of the test substance. No effects on clinical signs, body weight and macroscopic examinations were found. No mortality was observed. The LD50 is > 2000 mg/kg bw (Harlan 2012g).Groups of 5 rats/sex received a dermal application of 2000 mg/kg test substance during 24 hours under semi-occlusion. No effects other than slight irritation were found during the 14 day observation period. The dermal LD50 of the test substance is > 2000 mg/kg bw (Harlan 2013d) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/010f343d-2135-4216-85da-964bef5cdfaa/documents/IUC5-00a1b3c2-11bc-43fb-855f-0b7e67b00aea_4767a283-b267-4718-bb8d-774429a6f44c.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates",1393571-42-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/010f343d-2135-4216-85da-964bef5cdfaa/documents/IUC5-00a1b3c2-11bc-43fb-855f-0b7e67b00aea_4767a283-b267-4718-bb8d-774429a6f44c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18 and C18-unsatd., branched and linear, reaction products with diethylenetriamine and tall-oil fatty acids, Me maleates",1393571-42-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/010f343d-2135-4216-85da-964bef5cdfaa/documents/IUC5-00a1b3c2-11bc-43fb-855f-0b7e67b00aea_4767a283-b267-4718-bb8d-774429a6f44c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18 and C18-unsatd., Bu esters",84988-74-9,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0421b32-3adf-4e76-be02-54f629db6de7/documents/IUC5-2be39757-41f7-4a49-b03d-300254e7bacb_1b209943-9f20-4b84-8278-5e5b4045bd8f.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., Bu esters",84988-74-9,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0421b32-3adf-4e76-be02-54f629db6de7/documents/IUC5-b7765b29-fc70-4101-8017-28197aa32203_1b209943-9f20-4b84-8278-5e5b4045bd8f.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine",68424-19-1," A key repeated dose toxicity study with registered test substance was conducted according to OECD guideline TG 422 in rats at dose levels of 100, 300 or 1000 mg/ bw/day given by oral gavage. The study lasted  up to 32 days in male rats and 53 days in female rats. No relevant test item related changes were observed, except for microscopic changes like basophilic tubules and interstitial nephritis in the kidney of the male animals of the high dose group (1000 mg test item/kg bw/day). NOAEL (no-observed-adverse-effect level) for repeated dose toxicity was 300 mg/kg bw/day in males and 1000 mg/kg bw/day in females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bace340c-57cd-46fd-b48c-1fda1f898bf3/documents/IUC5-3b05bff3-5203-470a-8960-5774aacf2ce8_c803ac4a-30d7-48b9-9ac0-4dbc20b570a7.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine",68424-19-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bace340c-57cd-46fd-b48c-1fda1f898bf3/documents/IUC5-3b05bff3-5203-470a-8960-5774aacf2ce8_c803ac4a-30d7-48b9-9ac0-4dbc20b570a7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine",68424-19-1, Key studies were available for acute oral and dermal toxicity with test substance containing >95% active ingredient. Acute oral toxicity tested according to OECD TG 423 showed that LD50 was above limit dose of 2000 mg/kg bw. Acute dermal toxicity tested according to OECD TG 402 showed that LD50 was above limit dose of 2000 mg/kg bw. In both studies no signs of systemic toxicity were observed.  Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely due to the substance properties.  The available acute toxicity studies demonstrate that the substance is of low acute toxicity and needs no classification. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bace340c-57cd-46fd-b48c-1fda1f898bf3/documents/IUC5-8e59ff2f-5806-4b90-9def-7cda6027031d_c803ac4a-30d7-48b9-9ac0-4dbc20b570a7.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine",68424-19-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bace340c-57cd-46fd-b48c-1fda1f898bf3/documents/IUC5-8e59ff2f-5806-4b90-9def-7cda6027031d_c803ac4a-30d7-48b9-9ac0-4dbc20b570a7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18 and C18-unsatd., compds. with triethanolamine",68424-19-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bace340c-57cd-46fd-b48c-1fda1f898bf3/documents/IUC5-8e59ff2f-5806-4b90-9def-7cda6027031d_c803ac4a-30d7-48b9-9ac0-4dbc20b570a7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty Acids, C16-18 and C18-unsatd., diesters with 2-(3-hydroxypropyl)-6-[(3-hydroxypropyl)amino]-1H-benz[de]isoquinoline-1,3(2H)-dione)",190454-06-9," Acute Oral Toxicity, van Sas (2018) Under the conditions of the study, the oral LD50 value of the test material in Wistar rats was established to exceed 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7c1cbb7-5cec-472e-a150-4171b29e79e5/documents/81933748-9f78-4ac2-afee-ca4c2b5d0827_de0ae7cd-523f-4b98-87e0-490d6dc7a370.html,,,,,, "Fatty Acids, C16-18 and C18-unsatd., diesters with 2-(3-hydroxypropyl)-6-[(3-hydroxypropyl)amino]-1H-benz[de]isoquinoline-1,3(2H)-dione)",190454-06-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7c1cbb7-5cec-472e-a150-4171b29e79e5/documents/81933748-9f78-4ac2-afee-ca4c2b5d0827_de0ae7cd-523f-4b98-87e0-490d6dc7a370.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty-acids, C16-C18 + C18 unsatd., dimerized",71808-39-4,Based on read-across from a supporting substance (structural analogue) within a category approach:Oral: NOAEL (rat) = 741 (male) and 855 (female) mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6643e3d1-db0a-4054-9e30-9b826c23eeb0/documents/IUC5-b8339621-ece6-415d-b836-e6f2ceb8caeb_8bf5f5ca-694a-4179-8051-af350cba1610.html,,,,,, "Fatty-acids, C16-C18 + C18 unsatd., dimerized",71808-39-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6643e3d1-db0a-4054-9e30-9b826c23eeb0/documents/IUC5-b8339621-ece6-415d-b836-e6f2ceb8caeb_8bf5f5ca-694a-4179-8051-af350cba1610.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,741 mg/kg bw/day,,rat "Fatty-acids, C16-C18 + C18 unsatd., dimerized",71808-39-4,Based on read-across following a category approach: Oral: LD50 (rat) > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6643e3d1-db0a-4054-9e30-9b826c23eeb0/documents/IUC5-4f6b2382-1d25-42ba-b75b-d97bddadf3af_8bf5f5ca-694a-4179-8051-af350cba1610.html,,,,,, "Fatty-acids, C16-C18 + C18 unsatd., dimerized",71808-39-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6643e3d1-db0a-4054-9e30-9b826c23eeb0/documents/IUC5-4f6b2382-1d25-42ba-b75b-d97bddadf3af_8bf5f5ca-694a-4179-8051-af350cba1610.html,,oral,LD50,"5,000 mg/kg bw",, "Fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol",85711-45-1,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category. All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f4069b0-1a23-4fa2-8533-0259274dd14b/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_c4ae5eb3-93da-49e7-ab2e-fd4e37a1021a.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., esters with pentaerythritol",85711-45-1,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f4069b0-1a23-4fa2-8533-0259274dd14b/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_c4ae5eb3-93da-49e7-ab2e-fd4e37a1021a.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol",85049-34-9,"Oral (OECD 408, rat): NOAEL≥ >= 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34c46e0e-71dc-470c-8051-e61a75a619dd/documents/IUC5-f23abed3-4aa4-4373-bf11-25d9d40d1357_07c92d2c-a169-44d7-a157-454d9e72c567.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., esters with propylene glycol",85049-34-9,Oral: LD50 > 2000 mg/kg bwDermal : LD50 > 2000 mg/kg bwInhalation: no data available ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34c46e0e-71dc-470c-8051-e61a75a619dd/documents/IUC5-09b03c5a-503a-4017-af38-a9540de35eea_07c92d2c-a169-44d7-a157-454d9e72c567.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol",68604-38-6,"Repeated dose toxicity: Oral NOAEL (rat, m/f): 1000 mg/kg bw/day (OECD 408, GLP analogue approach)Repeated dose toxicity: Inhalation NOAEC (rat, m/f): 5.5 mg/L (OECD 413, analogue approach)Repeated dose toxicity: Dermal NOAEL (rat, m/f): 2000 mg/kg bw/day (OECD 411, analogue approach) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31bb2c95-06c6-4a26-a5e1-8c1d29509855/documents/IUC5-afc7293a-7019-4c40-aaa7-4d5ff33a19fc_1abf689c-3f56-4992-9d18-f433d47a1070.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol",68604-38-6,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401, analogue approach)Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, analogue approach)Acute toxicity: Inhalation LC50 (rat, m/f): > 5.1 mg/L air (OECD 403, analogue approach) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31bb2c95-06c6-4a26-a5e1-8c1d29509855/documents/IUC5-350ab39a-d03e-4983-b678-deb0a62240ee_1abf689c-3f56-4992-9d18-f433d47a1070.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., iso-Bu esters",84988-79-4,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/601ca05c-f1b6-43ec-9a42-b2dc86b74ae9/documents/IUC5-2be39757-41f7-4a49-b03d-300254e7bacb_70ceef10-2e00-41fb-a8ee-c74b5af3b45d.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., iso-Bu esters",84988-79-4,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/601ca05c-f1b6-43ec-9a42-b2dc86b74ae9/documents/IUC5-b7765b29-fc70-4101-8017-28197aa32203_70ceef10-2e00-41fb-a8ee-c74b5af3b45d.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues",68604-41-1,NOAEL subchronic toxicity rat > 250 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2653a042-6cd8-4e05-bea8-93c79cbafff9/documents/IUC5-3d4e2644-2375-44ab-9f53-94ef650f7bf3_c1c7913e-d7e6-4394-a3b4-9e7918ad7248.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues",68604-41-1,LD 50 = greater than 2000 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2653a042-6cd8-4e05-bea8-93c79cbafff9/documents/IUC5-dd39feb2-28b3-4dc7-9c41-9c5e317480fb_c1c7913e-d7e6-4394-a3b4-9e7918ad7248.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues",68604-41-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2653a042-6cd8-4e05-bea8-93c79cbafff9/documents/IUC5-dd39feb2-28b3-4dc7-9c41-9c5e317480fb_c1c7913e-d7e6-4394-a3b4-9e7918ad7248.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18 and C18-unsatd., Me esters, distn. residues",68604-41-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2653a042-6cd8-4e05-bea8-93c79cbafff9/documents/IUC5-dd39feb2-28b3-4dc7-9c41-9c5e317480fb_c1c7913e-d7e6-4394-a3b4-9e7918ad7248.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-C18 and C18-unsatd., ME esters, epoxidized",158318-67-3,"Key: NOAEL = 1000 mg/kg bw/d, rat, oral (gavage), 28 days (subacute), OECD 407, GLP, K1, 2013 Key: Read-across from CAS 95370-96-0: NOAEL = 1000 mg/kg bw/d, rat, oral (gavage), 90 days (subchronic), OECD 408, GLP, K1, 2022 Sup: Read-across from CAS 8013-07-8: NOEL (males) = 1000 mg/kg bw/d, NOEL (females) = 1400 mg/kg bw/d, rat, oral (feed), > 12 months (chronic), similar to OECD 453, non-GLP, K1/K2, 1986 Sup: Read-across from CAS 8013-07-8: NOAEL = 1250 mg/kg bw/d (5% in feed), rat and dog, oral (feed), > 6 months (chronic), no guideline followed, non-GLP, K2, 1960 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04e27bf5-9f80-448c-9001-623721a8bda5/documents/6137973c-9878-4a4a-a0a3-dd7fa1bb3e31_07a04e03-99b6-4247-932f-51b812d9a39e.html,,,,,, "Fatty acids, C16-C18 and C18-unsatd., ME esters, epoxidized",158318-67-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04e27bf5-9f80-448c-9001-623721a8bda5/documents/6137973c-9878-4a4a-a0a3-dd7fa1bb3e31_07a04e03-99b6-4247-932f-51b812d9a39e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C16-C18 and C18-unsatd., ME esters, epoxidized",158318-67-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04e27bf5-9f80-448c-9001-623721a8bda5/documents/6137973c-9878-4a4a-a0a3-dd7fa1bb3e31_07a04e03-99b6-4247-932f-51b812d9a39e.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C16-C18 and C18-unsatd., ME esters, epoxidized",158318-67-3,"Acute oral toxicityKey: Read-across from EC 701-432-9: LD50 > 2000 mg/kg bw, no mortality observed, rat, similar to OECD 401, non-GLP, K2, 1983 Sup: Read-across from CAS 8013-07-8: LD50 > 5000 mg/kg bw, no mortality observed, rat, no guideline followed, non-GLP, K2, 1981 Acute dermal toxicity Key: LD50 > 2000 mg/kg bw, no mortality observed, rat, OECD 402, GLP, K1, 2012   In accordance with column 2 of REACH Annex VIII, testing of the acute toxicity by inhalation is not appropriate as the substance is a liquid with a low vapour pressure (0.0000013 hPa at 20 °C) and inhalation of the substance is unlikely. Therefore, testing of the dermal route is more appropriate. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04e27bf5-9f80-448c-9001-623721a8bda5/documents/8ef958f3-766e-4691-8903-9708147dca48_07a04e03-99b6-4247-932f-51b812d9a39e.html,,,,,, "Fatty acids, C16-C18 and C18-unsatd., ME esters, epoxidized",158318-67-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04e27bf5-9f80-448c-9001-623721a8bda5/documents/8ef958f3-766e-4691-8903-9708147dca48_07a04e03-99b6-4247-932f-51b812d9a39e.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-C18 and C18-unsatd., ME esters, epoxidized",158318-67-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04e27bf5-9f80-448c-9001-623721a8bda5/documents/8ef958f3-766e-4691-8903-9708147dca48_07a04e03-99b6-4247-932f-51b812d9a39e.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-C18 and C18-unsatd., ME esters, epoxidized, reaction products with ethylen glycol",211450-54-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8478ff82-c5ba-4035-864f-1bac27607ab7/documents/5162da30-2be1-45b3-9a46-067b0c377fa6_ac729403-5410-47fa-973d-5d76a99bbf66.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Fatty acids, C16-C18 and C18-unsatd., ME esters, epoxidized, reaction products with ethylen glycol",211450-54-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8478ff82-c5ba-4035-864f-1bac27607ab7/documents/6f789303-9145-443b-a846-9bc12654a8c0_ac729403-5410-47fa-973d-5d76a99bbf66.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-C18 and C18-unsatd., ME esters, epoxidized, reaction products with ethylen glycol",211450-54-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8478ff82-c5ba-4035-864f-1bac27607ab7/documents/6f789303-9145-443b-a846-9bc12654a8c0_ac729403-5410-47fa-973d-5d76a99bbf66.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18 and C18-unsatd., mixed esters with adipic acid and trimethylolpropane",91001-61-5,WoE based on available data from surrogate substances:All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ab9b246-2911-4361-995f-c1b3d391c898/documents/IUC5-c474d123-d6a1-40a7-8fd4-29e3e4da07ce_82603163-2b52-4feb-b64a-7330bd8283b2.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., mixed esters with adipic acid and trimethylolpropane",91001-61-5,All available acute oral toxicity studies within this category resulted in acute oral LD50 > 5000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.05 mg/L. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ab9b246-2911-4361-995f-c1b3d391c898/documents/IUC5-583621d5-9bb4-48ce-8e87-ce7e790b3f02_82603163-2b52-4feb-b64a-7330bd8283b2.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol",68604-44-4,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category. All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1bc94643-a30f-41dd-b6eb-97fd6e17cee1/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_b1258d2f-f264-4ff5-8553-c6596024ec78.html,,,,,, "Fatty acids, C16-18 and C18-unsatd., tetraesters with pentaerythritol",68604-44-4,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bc94643-a30f-41dd-b6eb-97fd6e17cee1/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_b1258d2f-f264-4ff5-8553-c6596024ec78.html,,,,,, "Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters",91031-45-7,"Repeated dose toxicity: Oral NOAEL (rat, m/f): 1000 mg/kg bw/day (OECD 408) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf8684aa-d05f-49ff-8970-4185e6102aa5/documents/IUC5-f5e42d48-fa33-4c0f-8d6f-4ba4642f4b45_d77b4491-a50d-4ccb-8b80-0f8ca7bf9a8f.html,,,,,, "Fatty acids, C16-18, 1,2-ethanediylbis(oxy-2,1-ethanediyl) esters",91031-45-7,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401, analogue approach)Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, analogue approach)Acute toxicity: Inhalation LC50 (rat, m/f): > 2.916 mg/L air (OECD 403, analogue approach) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf8684aa-d05f-49ff-8970-4185e6102aa5/documents/IUC5-4e39ec26-e765-4c56-b377-5f270942fe48_d77b4491-a50d-4ccb-8b80-0f8ca7bf9a8f.html,,,,,, "Fatty acids, C16-18, 2-ethylhexyl esters",91031-48-0,"All available subacute and subchronic oral repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/d or greater. Studies on oral subacute repeated dose toxicity were available for the following category members (CAS#): 110-27-0, 135800-37-2 and 91031-48-0.Studies on oral subchronic repeated dose toxicity were available for the following category members (CAS#): 111-62-6, 163961-32-8 and for the metabolite 2-ethylhexanol (104-76-7). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78b2469c-70e4-475a-ab11-958113b927bf/documents/IUC5-27d5490d-28f1-400b-80cf-10ee5b0e041f_394156bf-be82-4dca-9322-68a395746aa6.html,,,,,, "Fatty acids, C16-18, 2-ethylhexyl esters",91031-48-0,"All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. Studies on acute oral toxicity were available for the following members of this category (CAS#): 10233-13-3, 110-27-0, 142-91-6, 112-11-8, 544-35-4, 26399-02-0, 135800-37-2, 91031-48-0, 29806-73-3, 123-95-5, 163961-32-8.All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. Studies on acute dermal toxicity were available for the following members of this category (CAS#): 544-35-4, 163961-32-8Studies on acute inhalation toxicity were available for the following members of this category (CAS#): 10233-13-3, 26399-02-0, 135800-37-2, 67762-63-4 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78b2469c-70e4-475a-ab11-958113b927bf/documents/IUC5-f52b06dc-25c4-4702-8227-c78aab43919e_394156bf-be82-4dca-9322-68a395746aa6.html,,,,,, "Fatty acids, C16-18, 2-hexyldecyl esters",101227-09-2,NOAEL systemic= 300 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/392f136f-669e-41af-8e42-35220ccb4b27/documents/IUC5-8c332a23-144b-4f95-8b09-06c83692644d_8c25537b-06fe-4d5a-8f85-ff034385ed56.html,,,,,, "Fatty acids, C16-18, 2-hexyldecyl esters",101227-09-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/392f136f-669e-41af-8e42-35220ccb4b27/documents/IUC5-8c332a23-144b-4f95-8b09-06c83692644d_8c25537b-06fe-4d5a-8f85-ff034385ed56.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Fatty acids, C16-18, 2-hexyldecyl esters",101227-09-2,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/392f136f-669e-41af-8e42-35220ccb4b27/documents/IUC5-d9d5ff68-edc5-44d0-b601-fd269435b6ed_8c25537b-06fe-4d5a-8f85-ff034385ed56.html,,,,,, "Fatty acids, C16-18, 2-hydroxyethyl esters",97281-23-7,Oral (OECD 408): NOAEL: 1000 mg/kg bw/day ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/91aa7a45-d1cb-4f3d-bec1-da7761be4f6e/documents/4fe9daca-2ce8-4619-a543-50ee8cad57d7_f564f5e1-cd71-4d0c-8ac1-425ac0181630.html,,,,,, "Fatty acids, C16-18, 2-hydroxyethyl esters",97281-23-7,Oral: LD50 > 2000 mg/kg bw Inhalation: LC50 > 2.916 mg/LDermal: LD50 > 2000 mg/kg bw ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91aa7a45-d1cb-4f3d-bec1-da7761be4f6e/documents/a088ef2b-1bc1-4159-a012-48b1444875c8_f564f5e1-cd71-4d0c-8ac1-425ac0181630.html,,,,,, "Fatty acids, C16-18, 2-octyldodecyl esters",96690-38-9,NOAEL systemic= 300 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d6470c60-0cb0-4cc2-8285-a6f48474183e/documents/IUC5-5ebc1a53-527b-484d-b6cf-fd1242616a5d_40429bfe-49db-4731-8b5d-954f51ba874c.html,,,,,, "Fatty acids, C16-18, 2-octyldodecyl esters",96690-38-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d6470c60-0cb0-4cc2-8285-a6f48474183e/documents/IUC5-5ebc1a53-527b-484d-b6cf-fd1242616a5d_40429bfe-49db-4731-8b5d-954f51ba874c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Fatty acids, C16-18, 2-octyldodecyl esters",96690-38-9,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6470c60-0cb0-4cc2-8285-a6f48474183e/documents/IUC5-b978fe4c-1f67-4f16-bed5-0f50fbcbb1bd_40429bfe-49db-4731-8b5d-954f51ba874c.html,,,,,, "Fatty acids, C16-18, Bu esters",85408-76-0,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb51f3c8-37d2-4a17-9178-de63bbb51fb3/documents/IUC5-2be39757-41f7-4a49-b03d-300254e7bacb_c919081d-206c-46e6-8d49-b31f6061652f.html,,,,,, "Fatty acids, C16-18, Bu esters",85408-76-0,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb51f3c8-37d2-4a17-9178-de63bbb51fb3/documents/IUC5-b7765b29-fc70-4101-8017-28197aa32203_c919081d-206c-46e6-8d49-b31f6061652f.html,,,,,, "Fatty acids, C16-18, C12-18-alkyl esters",95912-87-1,NOAEL systemic= 300 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e04c7c58-10df-4a3c-b0cd-916800704c68/documents/IUC5-7b5607b2-f424-4482-be37-66f97cb090c3_d2ab2bd2-b17e-45d9-8dc4-0e48b0a4d537.html,,,,,, "Fatty acids, C16-18, C12-18-alkyl esters",95912-87-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e04c7c58-10df-4a3c-b0cd-916800704c68/documents/IUC5-7b5607b2-f424-4482-be37-66f97cb090c3_d2ab2bd2-b17e-45d9-8dc4-0e48b0a4d537.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Fatty acids, C16-18, C12-18-alkyl esters",95912-87-1,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e04c7c58-10df-4a3c-b0cd-916800704c68/documents/IUC5-7022581e-a2c5-4e05-9e6c-789b7184f705_d2ab2bd2-b17e-45d9-8dc4-0e48b0a4d537.html,,,,,, "Fatty acids, C16-18, C16-18-alkyl esters",97404-33-6,NOAEL systemic= 300 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/834f34b1-ebd5-40be-9779-e902d69e8952/documents/IUC5-bbc980a7-92fc-4075-be21-81f4c9ff5396_6ba39070-0bb8-4f1c-b167-5058de2065d8.html,,,,,, "Fatty acids, C16-18, C16-18-alkyl esters",97404-33-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/834f34b1-ebd5-40be-9779-e902d69e8952/documents/IUC5-bbc980a7-92fc-4075-be21-81f4c9ff5396_6ba39070-0bb8-4f1c-b167-5058de2065d8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Fatty acids, C16-18, C16-18-alkyl esters",97404-33-6,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/834f34b1-ebd5-40be-9779-e902d69e8952/documents/IUC5-c7fb9798-8f4c-4e69-879d-1420c6635f00_6ba39070-0bb8-4f1c-b167-5058de2065d8.html,,,,,, "Fatty acids, C16-18, calcium salts",85251-71-4,"Dose responsive localized dermal effects at the test site (dorsal surface), consisting of scabbed post dose findings and elevated dermal scores. These findings were most pronounced at 1000 mg/kg bw/day and were seen most frequently at this dose level. The findings at 300 mg/kg bw/day were at a lower incidence and with lower dermal scores. Dermal scores and findings at 100 mg/kg bw/day were comparable to the controls. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d0fadce-a62f-4fff-a535-20eb9e07cd48/documents/ad7bdac2-f925-4efd-9da1-4bb4851b6ea4_6c59b09c-b4cb-4a7c-92e9-16cbff45bfbf.html,,,,,, "Fatty acids, C16-18, calcium salts",85251-71-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d0fadce-a62f-4fff-a535-20eb9e07cd48/documents/ad7bdac2-f925-4efd-9da1-4bb4851b6ea4_6c59b09c-b4cb-4a7c-92e9-16cbff45bfbf.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,089.75 mg/kg bw/day",,rat "Fatty acids, C16-18, calcium salts",85251-71-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d0fadce-a62f-4fff-a535-20eb9e07cd48/documents/ad7bdac2-f925-4efd-9da1-4bb4851b6ea4_6c59b09c-b4cb-4a7c-92e9-16cbff45bfbf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,500 mg/kg bw/day",,rat "Fatty acids, C16-18, calcium salts",85251-71-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d0fadce-a62f-4fff-a535-20eb9e07cd48/documents/ad7bdac2-f925-4efd-9da1-4bb4851b6ea4_6c59b09c-b4cb-4a7c-92e9-16cbff45bfbf.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.86 mg/cm2,adverse effect observed,rat "Fatty acids, C16-18, calcium salts",85251-71-4,It is considered from the results that all the substances in the category of calcium salts of C14-C22 monocarboxylic acids exhibit a similar lack of acute oral and dermal toxicity potential across the entire category. There is no evidence of a relevant intrinsic acute oral or dermal toxicity requiring classification or substance specific RMMs. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d0fadce-a62f-4fff-a535-20eb9e07cd48/documents/041bff4c-dada-486a-8ba0-f9ca88df1b10_6c59b09c-b4cb-4a7c-92e9-16cbff45bfbf.html,,,,,, "Fatty acids, C16-18, calcium salts",85251-71-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d0fadce-a62f-4fff-a535-20eb9e07cd48/documents/041bff4c-dada-486a-8ba0-f9ca88df1b10_6c59b09c-b4cb-4a7c-92e9-16cbff45bfbf.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18, calcium salts",85251-71-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d0fadce-a62f-4fff-a535-20eb9e07cd48/documents/041bff4c-dada-486a-8ba0-f9ca88df1b10_6c59b09c-b4cb-4a7c-92e9-16cbff45bfbf.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18, esters with diethylene glycol",85116-97-8,"Oral (OECD 408, rat) : NOAEL: 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/46eb062e-c364-4ac4-badf-302259669ec3/documents/IUC5-68ebc2d4-fe4e-490e-80b5-ee9efd761c59_0cd7f93a-57c2-4604-82bc-c0c1458b953f.html,,,,,, "Fatty acids, C16-18, esters with diethylene glycol",85116-97-8,"Oral: LD50 > 2000 mg/kg bw Inhalation: LC50 > 4.3 mg/L (time-extrapolated value, corresponding to 2.916 mg/L after 6 h exposure) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46eb062e-c364-4ac4-badf-302259669ec3/documents/IUC5-99c84553-84db-4a5a-b407-69ff8dd553aa_0cd7f93a-57c2-4604-82bc-c0c1458b953f.html,,,,,, "Fatty acids, C16-18, esters with ethylene glycol",91031-31-1,"Repeated dose toxicity: Oral NOAEL (rat, m/f): 1000 mg/kg bw/day (OECD 408, category approach)   The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114551285-49-01/F new studies with the registered substance will be conducted in the future. The finalised studies will be reported in an updated dossier until 22 July 2024 and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e19ae3d-80e0-4de2-8aec-11896c7ae9b6/documents/IUC5-33c8a40f-487b-4a38-9afa-aeda36b14f47_b64291fa-7381-48ac-82e1-7af5c8949e41.html,,,,,, "Fatty acids, C16-18, esters with ethylene glycol",91031-31-1,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401, GLP, category approach) Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, GLP, category approach) Acute toxicity: Inhalation LC50 (rat, m/f): > 2.916 mg/L air (OECD 403, category approach)   The hazard assessment is based on the data currently available. Pursuant to ECHA decision on a compliance check CCH-D-2114551285-49-01/F new studies with the registered substance will be conducted in the future. The finalised studies will be reported in an updated dossier until 22 July 2024 and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the glycol esters category. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e19ae3d-80e0-4de2-8aec-11896c7ae9b6/documents/IUC5-9f68a308-2ca5-4bcd-a872-36d1379955f8_b64291fa-7381-48ac-82e1-7af5c8949e41.html,,,,,, "Fatty acids, C16-18, esters with pentaerythritol",85116-93-4,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.   All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ea85355-8217-41be-9264-67eb5aca1fe2/documents/IUC5-3bee8ea8-9bb7-426f-b4e4-c21647768fee_336b167d-1bf0-4d94-9d29-2ae9b3111775.html,,,,,, "Fatty acids, C16-18, esters with pentaerythritol",85116-93-4,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category. All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ea85355-8217-41be-9264-67eb5aca1fe2/documents/IUC5-c851a21c-3fff-4afd-9313-51003e688e88_336b167d-1bf0-4d94-9d29-2ae9b3111775.html,,,,,, "Fatty acids, C16-18, iso-Bu esters",85865-69-6,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0545bce3-7fab-4a73-934d-02d2889f1e92/documents/IUC5-2be39757-41f7-4a49-b03d-300254e7bacb_74b4cae8-b62f-40ee-bdfb-474d5d0fa5b6.html,,,,,, "Fatty acids, C16-18, iso-Bu esters",85865-69-6,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0545bce3-7fab-4a73-934d-02d2889f1e92/documents/IUC5-b7765b29-fc70-4101-8017-28197aa32203_74b4cae8-b62f-40ee-bdfb-474d5d0fa5b6.html,,,,,, "Fatty acids, C16-18, isononyl esters",91031-57-1," Oral (OECD 422, read across): NOAEL female rat = 300 mg/kg bw/day Oral (OECD 422, read across): NOAEL male rat = 1000 mg/kg bw/day Oral (OECD 407, read across): NOAEL, male and female rat >1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33fa7c83-2e12-491f-84e8-67b672e7781b/documents/5bd193a2-cd29-4e2a-8ef2-bac3563c5998_f2d70711-9936-441c-9c2a-8fc3a814fecd.html,,,,,, "Fatty acids, C16-18, isononyl esters",91031-57-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33fa7c83-2e12-491f-84e8-67b672e7781b/documents/5bd193a2-cd29-4e2a-8ef2-bac3563c5998_f2d70711-9936-441c-9c2a-8fc3a814fecd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Fatty acids, C16-18, isononyl esters",91031-57-1, Oral (similar to OECD 401): LD50 > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33fa7c83-2e12-491f-84e8-67b672e7781b/documents/479da6a9-e1de-4d3f-ab7f-6230983011b1_f2d70711-9936-441c-9c2a-8fc3a814fecd.html,,,,,, "Fatty acids, C16-18, isononyl esters",91031-57-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33fa7c83-2e12-491f-84e8-67b672e7781b/documents/479da6a9-e1de-4d3f-ab7f-6230983011b1_f2d70711-9936-441c-9c2a-8fc3a814fecd.html,,oral,,"> 5,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18, iso-Pr esters",91031-58-2,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ddd38bef-6efe-4edf-a6e9-afbc9138af50/documents/IUC5-e6b759d8-1ea2-403d-8186-c8b8be61861e_37fe357c-3bb6-42d9-9891-c8331645e9df.html,,,,,, "Fatty acids, C16-18, iso-Pr esters",91031-58-2,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ddd38bef-6efe-4edf-a6e9-afbc9138af50/documents/IUC5-7e0bce4e-7a75-42af-8de8-e36bf15f23c9_37fe357c-3bb6-42d9-9891-c8331645e9df.html,,,,,, "Fatty acids, C16-18, isotridecyl esters",95912-88-2,NOAEL systemic= 300 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f65840c6-874e-4f9a-b82f-b737f811ebf8/documents/IUC5-762c062b-aa79-4e8f-8552-26419220906b_31155cd1-88f3-412f-831a-8baaf850822f.html,,,,,, "Fatty acids, C16-18, isotridecyl esters",95912-88-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f65840c6-874e-4f9a-b82f-b737f811ebf8/documents/IUC5-762c062b-aa79-4e8f-8552-26419220906b_31155cd1-88f3-412f-831a-8baaf850822f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Fatty acids, C16-18, isotridecyl esters",95912-88-2,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f65840c6-874e-4f9a-b82f-b737f811ebf8/documents/IUC5-e1a1198c-9e4b-42fe-b4a1-8b4e8f9766f0_31155cd1-88f3-412f-831a-8baaf850822f.html,,,,,, "Fatty acids, C16-18, lead salts",91031-62-8," Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9840fef6-9a2a-4367-9fc2-c7024c0a61b7/documents/55240df1-e7fa-4fe8-8269-766f9e1416fc_125f8272-0b9b-42c3-9c3c-bfe42acfffd4.html,,,,,, "Fatty acids, C16-18, lead salts",91031-62-8, Inorganic lead compounds do not exhibit toxicity in acute toxicity tests with experimental animals. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9840fef6-9a2a-4367-9fc2-c7024c0a61b7/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_125f8272-0b9b-42c3-9c3c-bfe42acfffd4.html,,,,,, "Fatty acids, C16-18, lead salts",91031-62-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9840fef6-9a2a-4367-9fc2-c7024c0a61b7/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_125f8272-0b9b-42c3-9c3c-bfe42acfffd4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18, lead salts",91031-62-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9840fef6-9a2a-4367-9fc2-c7024c0a61b7/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_125f8272-0b9b-42c3-9c3c-bfe42acfffd4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18, lead salts",91031-62-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9840fef6-9a2a-4367-9fc2-c7024c0a61b7/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_125f8272-0b9b-42c3-9c3c-bfe42acfffd4.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Fatty acids, C16-18, lithium salts",68783-37-9,"OECD 422 combined repeat dose and reproductive toxicity screening studies have been conducted on key substances which fall in the definition of the Lithium salts of monocarboxylic acids C14-C22 category. Studies were conducted via oral gavage on lithium myristate, fatty acids C16-18 lithium salts and fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. A study via dietary administration was conducted on lithium 12-hydroxystearate and a dermal study was conducted on fatty acids C18-(unsaturated) lithium salts. The NOAEL was >=500 mg/kg body weight/day for lithium myristate and fatty acids C16-18 lithium salts and was 250 mg/kg body weight/day for fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. The NOAEL for lithium 12-hydroxystearate was 2000 ppm (144 and 161 mg/kg body weight/day for males and females, respectively) based on parental body weights. The NOAEL for fatty acids C18-(unsaturated) lithium salts was 1089.75 mg/kg body weight/day based on systemic effects and 111.25 mg/kg body weight/day based on dermal scores. The results for the tested substances have been read across to the other members of the lithium salts of monocarboxylic acids C14-C22 category. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/435292f5-b9ee-4cbb-a5c6-711b3cd39345/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_f4c67f31-a057-4afa-ac3a-7a14bb968979.html,,,,,, "Fatty acids, C16-18, lithium salts",68783-37-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/435292f5-b9ee-4cbb-a5c6-711b3cd39345/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_f4c67f31-a057-4afa-ac3a-7a14bb968979.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,144 mg/kg bw/day,,rat "Fatty acids, C16-18, lithium salts",68783-37-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/435292f5-b9ee-4cbb-a5c6-711b3cd39345/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_f4c67f31-a057-4afa-ac3a-7a14bb968979.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,089.75 mg/kg bw/day",,rat "Fatty acids, C16-18, lithium salts",68783-37-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/435292f5-b9ee-4cbb-a5c6-711b3cd39345/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_f4c67f31-a057-4afa-ac3a-7a14bb968979.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.86 mg/cm2,adverse effect observed,rat "Fatty acids, C16-18, lithium salts",68783-37-9,"Oral acute toxicity studies in rats were conducted on lithium myristate, fatty acids C18-(unsaturated) lithium salts, lithium docosanoate, and fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. All studies reported no mortality and LD50 values greater than 2000 mg/kg bodyweight. These data have been read across to the other substances in the lithium salts of monocarboxylic acids C14-C22 category. A dermal toxicity study in rats was conducted on fatty acids C18-(unsaturated) lithium salts. The study reported no mortality and LD50 values greater than 2000 mg/kg bodyweight. These data have been read across to the other substances in the lithium salts of monocarboxylic acids C14-C22 category. An estimate of the inhalation dust/mist toxicity by route-to-route extrapolation using conservative standard default values results in an ATE of 10.4 mg/L/4 hours minimum. This value is well above the cut values for classification for acute inhalation toxicity hazard. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/435292f5-b9ee-4cbb-a5c6-711b3cd39345/documents/754e9131-4245-46c3-8876-e6b64b352e18_f4c67f31-a057-4afa-ac3a-7a14bb968979.html,,,,,, "Fatty acids, C16-18, lithium salts",68783-37-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/435292f5-b9ee-4cbb-a5c6-711b3cd39345/documents/754e9131-4245-46c3-8876-e6b64b352e18_f4c67f31-a057-4afa-ac3a-7a14bb968979.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18, lithium salts",68783-37-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/435292f5-b9ee-4cbb-a5c6-711b3cd39345/documents/754e9131-4245-46c3-8876-e6b64b352e18_f4c67f31-a057-4afa-ac3a-7a14bb968979.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18, Me esters",85586-21-6,"All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air.While no reliable acute dermal toxicity studies are available., the picture of all available data is consistent supporting also a low level of dermal toxicity for the category of fatty acid methyl esters. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5950448b-4b8c-4ed2-9fb4-09a52d796294/documents/3088d86d-2dc4-47e3-ae63-e1a6f35fc19f_884ed567-9f3a-43c7-98cb-9c073733705f.html,,,,,, "Fatty acids, C16-18, reaction products with diethanolamine",91032-08-5," The repeated dose administration of the Fatty acids, C16-18-, reaction products with diethanolamine to the male (minimum 28 days) and female (maximum 54 days) Wistar rats at dosages of 100, 300 and 1000 mg/kg body weight revealed neither mortalities nor findings of toxicological relevance in male and female animals. There were also no toxicologically relevant findings noted for reproductive and developmental parameters. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a970bd2-18e7-4753-978b-85952c92323e/documents/4ed11ce9-0fc9-4daf-be01-6ed0bcb59e82_a8e97131-e422-4c82-8241-f0ffe62c609c.html,,,,,, "Fatty acids, C16-18, reaction products with diethanolamine",91032-08-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a970bd2-18e7-4753-978b-85952c92323e/documents/4ed11ce9-0fc9-4daf-be01-6ed0bcb59e82_a8e97131-e422-4c82-8241-f0ffe62c609c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C16-18, reaction products with diethanolamine",91032-08-5, The test material did not cause any adverse effects after singel oral or dermal administration to rats at a dose level of 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a970bd2-18e7-4753-978b-85952c92323e/documents/a0c7a46c-669e-4f47-9174-7d1aae609e48_a8e97131-e422-4c82-8241-f0ffe62c609c.html,,,,,, "Fatty acids, C16-18, reaction products with diethanolamine",91032-08-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a970bd2-18e7-4753-978b-85952c92323e/documents/a0c7a46c-669e-4f47-9174-7d1aae609e48_a8e97131-e422-4c82-8241-f0ffe62c609c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18, reaction products with diethanolamine",91032-08-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a970bd2-18e7-4753-978b-85952c92323e/documents/a0c7a46c-669e-4f47-9174-7d1aae609e48_a8e97131-e422-4c82-8241-f0ffe62c609c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18, reaction products with diethylenetriamine",85711-52-0, NOAEL > 1000 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/987adc80-6c17-48bc-8523-f742f57e9534/documents/0ea9339a-1574-4e7c-8afa-6ff642fc3eff_5ca2f125-9180-4701-be9d-100a2857bd78.html,,,,,, "Fatty acids, C16-18, reaction products with diethylenetriamine",85711-52-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/987adc80-6c17-48bc-8523-f742f57e9534/documents/0ea9339a-1574-4e7c-8afa-6ff642fc3eff_5ca2f125-9180-4701-be9d-100a2857bd78.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C16-18, reaction products with diethylenetriamine",85711-52-0," LD50, oral > 2000 mg/kg LD50, dermal > 2000 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/987adc80-6c17-48bc-8523-f742f57e9534/documents/1eef2387-7cbe-4c8b-a008-75885cb1323f_5ca2f125-9180-4701-be9d-100a2857bd78.html,,,,,, "Fatty acids, C16-18, stearyl esters",85536-04-5," Oral (OECD 422, read across): NOAEL m/f rat ≥ 1000 mg/kg bw/day Oral (OECD 407, read across): NOAEL m/f rat ≥ 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6af340ec-bde0-4cbd-b0cc-68e0e0187a0e/documents/8ebfb7ad-4221-4524-b911-0a4bdaa79a60_abf49ee6-d3ef-4564-aaa7-9eae69be3b2d.html,,,,,, "Fatty acids, C16-18, stearyl esters",85536-04-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6af340ec-bde0-4cbd-b0cc-68e0e0187a0e/documents/8ebfb7ad-4221-4524-b911-0a4bdaa79a60_abf49ee6-d3ef-4564-aaa7-9eae69be3b2d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C16-18, stearyl esters",85536-04-5," Oral (read across, similar to OECD 401): LD50 m/f rat > 5000 mg/kg bw Inhalation (read across, OECD 436): LC50 m/f rat: >5.7 mg/L air Dermal (read across, OECD 402): LD50 m/f rat > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6af340ec-bde0-4cbd-b0cc-68e0e0187a0e/documents/548f4a1d-bd44-4cd2-8a95-22c6d760070c_abf49ee6-d3ef-4564-aaa7-9eae69be3b2d.html,,,,,, "Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol]",91050-80-5,"Repeated dose toxicity: Oral NOAEL (rat, m/f): >1000 mg/kg bw/day (OECD 408, analogue approach) ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4b23e6d-8ccb-4eff-b95c-ad0e8976f546/documents/IUC5-3d8e907a-20a0-408a-a85c-9f6dc48a85f1_153e0d9e-38f8-40d7-9c4b-f60a1378e15a.html,,,,,, "Fatty acids, C16-18, tetraesters with 3,3'-oxybis[1,2-propanediol]",91050-80-5,"Acute toxicity: Oral LD50 (rat, m/f): > 5000 mg/kg bw (OECD 401, GLP, analogue approach)Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, GLP, analogue approach)Acute toxicity: Inhalation LC50 (rat, m/f): > 5.0 mg/L air (OECD 403, analogue approach) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4b23e6d-8ccb-4eff-b95c-ad0e8976f546/documents/IUC5-6c6a6d32-dde4-4bdf-8345-29e99ecd78fa_153e0d9e-38f8-40d7-9c4b-f60a1378e15a.html,,,,,, "Fatty acids, C16-18, tetraesters with pentaerythritol",91050-82-7,All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c114ea1-a1df-4288-a9c1-b486b7fec9e7/documents/IUC5-0f82af4c-3373-4484-b32e-f3993fa75d8e_0bb8e9a5-3542-4500-9096-db9ce799291e.html,,,,,, "Fatty acids, C16-18, tetraesters with pentaerythritol",91050-82-7,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c114ea1-a1df-4288-a9c1-b486b7fec9e7/documents/IUC5-1a0e5b55-c7fd-4c57-bb29-b184fb5a159f_0bb8e9a5-3542-4500-9096-db9ce799291e.html,,,,,, "Fatty acids, C16-18, zinc salts",91051-01-3," No repeated dose toxicity study with Fatty acids, C16-18, zinc salts is available, thus the repeated dose toxicity will be addressed with existing data on the moieties liberated upon dissolution, zinc and fatty acids, C16 -18. In relevant and reliable repeated dose toxicity studies for the moiety zinc of Fatty acids, C16-18, zinc salts, and in peer-reviewed publicly available assessment reports for the moiety fatty acids, C16-18, there were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/013e4170-a0e2-46a1-aeef-0f1d8eafd8d9/documents/IUC5-d53b1977-8495-4d9a-a9a0-cc7757ec41d6_66fa7fad-6139-4c01-9259-fa3b4a9d45b8.html,,,,,, "Fatty acids, C16-18, zinc salts",91051-01-3," A key study for acute oral toxicity with fatty acids, C16-18, zinc salts is available (OECD 401) indicating a LD50 > 5000 mg/kg bw.   A key study for acute inhalation toxicity with fatty acids, C16-18, zinc salts is available indicating a LC50 > 50 mg/L.   A key study for acute dermal toxicity with fatty acids, C16-18, zinc salts is available indicating a LD50 > 2000 mg/kg bw.   In conclusion, the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral, inhalation and dermal toxicity as well as for specific target organ toxicity, single exposure (STOT SE). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/013e4170-a0e2-46a1-aeef-0f1d8eafd8d9/documents/IUC5-d48c2449-b612-4627-8a48-4d237e59ce27_66fa7fad-6139-4c01-9259-fa3b4a9d45b8.html,,,,,, "Fatty acids, C16-18, zinc salts",91051-01-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/013e4170-a0e2-46a1-aeef-0f1d8eafd8d9/documents/IUC5-d48c2449-b612-4627-8a48-4d237e59ce27_66fa7fad-6139-4c01-9259-fa3b4a9d45b8.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18, zinc salts",91051-01-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/013e4170-a0e2-46a1-aeef-0f1d8eafd8d9/documents/IUC5-d48c2449-b612-4627-8a48-4d237e59ce27_66fa7fad-6139-4c01-9259-fa3b4a9d45b8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-18, zinc salts",91051-01-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/013e4170-a0e2-46a1-aeef-0f1d8eafd8d9/documents/IUC5-d48c2449-b612-4627-8a48-4d237e59ce27_66fa7fad-6139-4c01-9259-fa3b4a9d45b8.html,,inhalation,LC50,"50,000 mg/m3",no adverse effect observed, "Fatty acids, C16-22",68002-88-0,"Reliable studies on oral repeated dose toxicity are available for the following category members:Subchronic: NOAEL oral = ca. 5000 mg/kg bw/d; CAS# 143-07-7, C12 (Fitzhugh 1960)Subchronic: NOAEL oral = 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao 2002)No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/caeaa4cf-cc37-4f36-82cb-c125467a6268/documents/c1954424-46fd-4f24-932f-9802443fbc82_a167f81e-84eb-47c0-a911-553f8568dd0f.html,,,,,, "Fatty acids, C16-22",68002-88-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/caeaa4cf-cc37-4f36-82cb-c125467a6268/documents/c1954424-46fd-4f24-932f-9802443fbc82_a167f81e-84eb-47c0-a911-553f8568dd0f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C16-22",68002-88-0,"Acute toxicity:- oral: LD50 >5000 mg/kg bw (OECD 401; Analogy CAS CAS 57-10-3, CAS 57-11-4, CAS 112-85-6 );- inhalative: LC50 >0.1521 mg/L (IHT; Analogy CAS 124-07-2);- dermal: LD50 > 2000 mg/kg bw (Analogy CAS 57-11-4); ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/caeaa4cf-cc37-4f36-82cb-c125467a6268/documents/IUC5-20ebcab0-c0d0-43f5-ab7c-ef4beb0c8aa7_a167f81e-84eb-47c0-a911-553f8568dd0f.html,,,,,, "Fatty acids, C16-22, lithium salts",68783-36-8,"OECD 422 combined repeat dose and reproductive toxicity screening studies have been conducted on key substances which fall in the definition of the Lithium salts of monocarboxylic acids C14-C22 category. Studies were conducted via oral gavage on lithium myristate, fatty acids C16-18 lithium salts and fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. A study via dietary administration was conducted on lithium 12-hydroxystearate and a dermal study was conducted on fatty acids C18-(unsaturated) lithium salts. The NOAEL was >=500 mg/kg body weight/day for lithium myristate and fatty acids C16-18 lithium salts and was 250 mg/kg body weight/day for fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. The NOAEL for lithium 12-hydroxystearate was 2000 ppm (144 and 161 mg/kg body weight/day for males and females, respectively) based on parental body weights. The NOAEL for fatty acids C18-(unsaturated) lithium salts was 1089.75 mg/kg body weight/day based on systemic effects and 111.25 mg/kg body weight/day based on dermal scores. The results for the tested substances have been read across to the other members of the lithium salts of monocarboxylic acids C14-C22 category. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dbb04046-61c3-47c3-86d3-8f27989bdd30/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_5dba7846-b6b8-435b-82cb-f8d84c5e3947.html,,,,,, "Fatty acids, C16-22, lithium salts",68783-36-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dbb04046-61c3-47c3-86d3-8f27989bdd30/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_5dba7846-b6b8-435b-82cb-f8d84c5e3947.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,144 mg/kg bw/day,,rat "Fatty acids, C16-22, lithium salts",68783-36-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dbb04046-61c3-47c3-86d3-8f27989bdd30/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_5dba7846-b6b8-435b-82cb-f8d84c5e3947.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,089.75 mg/kg bw/day",,rat "Fatty acids, C16-22, lithium salts",68783-36-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dbb04046-61c3-47c3-86d3-8f27989bdd30/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_5dba7846-b6b8-435b-82cb-f8d84c5e3947.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.86 mg/cm2,adverse effect observed,rat "Fatty acids, C16-22, lithium salts",68783-36-8,"Oral acute toxicity studies in rats were conducted on lithium myristate, fatty acids C18-(unsaturated) lithium salts, lithium docosanoate, and fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. All studies reported no mortality and LD50 values greater than 2000 mg/kg bodyweight. These data have been read across to the other substances in the lithium salts of monocarboxylic acids C14-C22 category. A dermal toxicity study in rats was conducted on fatty acids C18-(unsaturated) lithium salts. The study reported no mortality and LD50 values greater than 2000 mg/kg bodyweight. These data have been read across to the other substances in the lithium salts of monocarboxylic acids C14-C22 category. An estimate of the inhalation dust/mist toxicity by route-to-route extrapolation using conservative standard default values results in an ATE of 10.4 mg/L/4 hours minimum. This value is well above the cut values for classification for acute inhalation toxicity hazard. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbb04046-61c3-47c3-86d3-8f27989bdd30/documents/754e9131-4245-46c3-8876-e6b64b352e18_5dba7846-b6b8-435b-82cb-f8d84c5e3947.html,,,,,, "Fatty acids, C16-22, lithium salts",68783-36-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbb04046-61c3-47c3-86d3-8f27989bdd30/documents/754e9131-4245-46c3-8876-e6b64b352e18_5dba7846-b6b8-435b-82cb-f8d84c5e3947.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C16-22, lithium salts",68783-36-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbb04046-61c3-47c3-86d3-8f27989bdd30/documents/754e9131-4245-46c3-8876-e6b64b352e18_5dba7846-b6b8-435b-82cb-f8d84c5e3947.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C18 unsat, reaction products with diethylenetriamine",1226892-43-8,"The 90-day NOAEL is 10 mg/kg bw/d. At higher dose levels an increase of the presence of foamy macrophages in the lamina propria of the small intestines and mesenteric lymph nodes is observed, as well as lower mean body weight and body weight gain, especially in the males, with lower food intake, essentially during the second half of the treatment period. Also the combined repeated dose/reproduction screening toxicity study according to OECD 422 with AAI-DETA resulted to a NOAEL of 10 mg/kg bw/day based on the increased incidence/severity of macrophage foci in the mesenteric lymph nodes at higher dose levels. Other available data from the group of AAI substances, including 90-day studies in rat and dogs on a very similar substance, indicate low repeated dose toxicity. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Consistent results from all studies within the whole group of Amidoamine/imidazolines (AAI). Available studies are OECD Guideline compliant and performed under GLP. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01a9271f-1f40-486d-8c6a-436f3140de22/documents/IUC5-d38d9692-c395-4d39-a8d0-324fb318d8df_8ef5bc15-9b81-4878-b760-6f2e9e034f5b.html,,,,,, "Fatty acids, C18 unsat, reaction products with diethylenetriamine",1226892-43-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01a9271f-1f40-486d-8c6a-436f3140de22/documents/IUC5-d38d9692-c395-4d39-a8d0-324fb318d8df_8ef5bc15-9b81-4878-b760-6f2e9e034f5b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "Fatty acids, C18 unsat, reaction products with diethylenetriamine",1226892-43-8,"Acute toxicity: Oral LD50 > 2000 mg/kg for rat (LD50 cut-off: 2500 mg/kg bw). No acute dermal and inhalation toxicity studies were performed on the substance due to its corrosive properties. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Both available studies are guideline (OECD 423, ACT) studies performed under GLP ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01a9271f-1f40-486d-8c6a-436f3140de22/documents/IUC5-37fdd7bf-6416-46cb-b9eb-eeb2ceef0959_8ef5bc15-9b81-4878-b760-6f2e9e034f5b.html,,,,,, "Fatty acids, C18 unsat, reaction products with diethylenetriamine",1226892-43-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01a9271f-1f40-486d-8c6a-436f3140de22/documents/IUC5-37fdd7bf-6416-46cb-b9eb-eeb2ceef0959_8ef5bc15-9b81-4878-b760-6f2e9e034f5b.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, "Fatty acids, C18 unsaturated, trimers, hydrogenated",1373883-45-4,"Based on read-across from Fatty acids, C18-unsaturated, dimers (CAS No. 61788-89-4):Oral: NOAEL (rat, subchronic) = 741 (males) and 855 (females) mg/kg bw/day (similar to OECD 408, GLP) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cede805c-fbda-447c-9afd-819027e0806e/documents/IUC5-d8719d19-270f-47b4-a948-efe6076a4262_eb8f7490-9bb6-469e-9d4f-8673cf5f5c3a.html,,,,,, "Fatty acids, C18 unsaturated, trimers, hydrogenated",1373883-45-4,"Oral: LD50 (rat, m/f) > 5000 mg/kg bw (OECD 401, GLP, read-across from structurally similar substances)Dermal: LD50 (rat, m/f) > 2000 mg/kg bw (OECD 402, GLP) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cede805c-fbda-447c-9afd-819027e0806e/documents/IUC5-5376ce07-bb3d-4020-b593-04ed5bc4d119_eb8f7490-9bb6-469e-9d4f-8673cf5f5c3a.html,,,,,, "Fatty acids, C18-22",90990-11-7,"Key studies on oral repeated dose toxicity are available for the following category members:Subchronic (84 days, rat): NOAEL oral ≥ 12500 mg/kg bw/day; CAS# 112-80-1, C18:1 (Calandra, 1969)Subacute (OECD 422, rat): NOAEL oral ≥ 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao et al., 2002)Subacute (OECD 407, rat): NOAEL oral ≥ 1000 mg/kg bw/day; CAS# 112-05-0, C9 (van Otterdijk, 2002)Subacute (OECD 407, rat): NOAEL oral ≥ 1000 mg/kg bw/day; CAS# 70321-72-1, C8-18 and C18-unsatd, distn. residues (Potokar, 1983)In conclusion, no human hazard for systemic toxicity after repeated oral exposure was identified for the members of the fatty acids category.No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a8e8926-2742-4f08-93c7-ded7fcc5873c/documents/IUC5-8dec131f-cec7-4faf-b28f-751d35c4501c_a38acd81-27af-4633-93fe-18bb7ed19087.html,,,,,, "Fatty acids, C18-22",90990-11-7,"Oral (OECD 401, limit test), rat: LD50 > 2000 mg/kg bw (Potokar, 1982)Inhalation, IRT, rat, 8h: LC50 >1.3682 mg/L air; CAS# 142-62-1, C6 (Smyth et al., 1954)Dermal (OECD 402, limit test), rat: LD50 >2000 mg/kg bw ; CAS# 112-05-0, C9 (van Otterdijk, 2001)Dermal (OECD 402, limit test), rat: LD50 >2000 mg/kg bw; CAS# 111-20-6, C10d (Yu, 1999)Dermal (OECD 402, limit test), rat: LD50 >2000 mg/kg bw; CAS# 334-48-5, C10 (TalviOja, 2006) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a8e8926-2742-4f08-93c7-ded7fcc5873c/documents/IUC5-edd57af1-4ab8-4a5f-a1bc-eb822b382dd1_a38acd81-27af-4633-93fe-18bb7ed19087.html,,,,,, "Fatty acids, C18-24, zinc salts",84776-57-8," No repeated dose study with substance Fatty acids, C18-24, zinc salts is available, thus the repeated dose toxicity will be addressed with existing data on the entities formed upon dissolution of substance Fatty acids, C18-24, zinc salt, namely zinc and fatty acids, C18-24. Since the naturally occurring fatty acids are void of any human health hazard potential, the hazard assessment will be derived based on the toxicological information for zinc and the human life-time NOAEL of 0.83 mg/kg bw/day will be used. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4a6bb3e-668f-4dbb-9821-dfe9aff0a116/documents/6b6d6741-e663-4a57-8061-afb3aabffdcc_2dd78516-21c0-4051-875b-ed962bd08214.html,,,,,, "Fatty acids, C18-24, zinc salts",84776-57-8," No acute toxicity studies with substance Fatty acids, C18-24, zinc salts are available, thus the acute toxicity will be addressed with existing data on the structural analog substances fatty acid(s), C8, C12, C18OH and C16-18 zinc salt(s) and the dissociation products zinc and fatty acids, C18-24. Signs of acute toxicity are not expected for substance Fatty acids, C18-24, zinc salts, since the structurally related fatty acid(s) zinc salts, as well as the moieties zinc and fatty acids, C18-24 are of low toxicity with dose descriptors (LD(C)50) above the guideline limits, respectively no adverse effect expected based on other information. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4a6bb3e-668f-4dbb-9821-dfe9aff0a116/documents/e344ce50-736a-42f8-8d77-4a5dac37b1dd_2dd78516-21c0-4051-875b-ed962bd08214.html,,,,,, "Fatty acids, C18-unsatd, dimers, hydrogenated, diisopropyl esters",103213-20-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises adequate, reliable (Klimisch score 2) and consistent studies from a reference substance with similar structure and intrinsic properties. Read-across is justified based on structural similarity between the source and target substances, the source substance being a product of the hydrolysis of the target substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2bd3545d-8206-46a8-b4a4-882f21a33fcd/documents/e5bc33f2-133b-4d76-bac8-985fde6f7265_e90a2117-b9d1-4d7c-95d3-48e4034ef37b.html,,,,,, "Fatty acids, C18-unsatd, dimers, hydrogenated, diisopropyl esters",103213-20-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2bd3545d-8206-46a8-b4a4-882f21a33fcd/documents/e5bc33f2-133b-4d76-bac8-985fde6f7265_e90a2117-b9d1-4d7c-95d3-48e4034ef37b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,618 mg/kg bw/day,,rat "Fatty acids, C18-unsatd, dimers, hydrogenated, diisopropyl esters",103213-20-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate, reliable (Klimisch score 2) studies from reference substances with similar structure and intrinsic properties and fromhydrolysis products. Read-across is justified either based on structural similarity or common precursors/breakdown products. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The available information comprises adequate, reliable (Klimisch score 2) studies from reference substances with similar structure and intrinsic properties. Read-across is justified based on common origin, common precursors and breakdown products of hydrolysis and consistent trends in the toxicological profile. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bd3545d-8206-46a8-b4a4-882f21a33fcd/documents/fcaa6651-723d-4c2e-8787-73c854629d94_e90a2117-b9d1-4d7c-95d3-48e4034ef37b.html,,,,,, "Fatty acids, C18-unsatd., dimers",61788-89-4,Oral: NOAEL (rat) = 741 (male) and 855 (female) mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58051871-f367-4da7-8756-b2665b63cb98/documents/IUC5-1d2e7150-8462-4b88-ae2d-d5820ae4b532_a50c6a9e-c39e-4700-8395-51123ba0193f.html,,,,,, "Fatty acids, C18-unsatd., dimers",61788-89-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58051871-f367-4da7-8756-b2665b63cb98/documents/IUC5-1d2e7150-8462-4b88-ae2d-d5820ae4b532_a50c6a9e-c39e-4700-8395-51123ba0193f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,741 mg/kg bw/day,,rat "Fatty acids, C18-unsatd., dimers",61788-89-4,Oral: LD 50 (rat) > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58051871-f367-4da7-8756-b2665b63cb98/documents/IUC5-313187f8-4fc3-49b9-ad77-c2843b46e436_a50c6a9e-c39e-4700-8395-51123ba0193f.html,,,,,, "Fatty acids, C18-unsatd., dimers",61788-89-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58051871-f367-4da7-8756-b2665b63cb98/documents/IUC5-313187f8-4fc3-49b9-ad77-c2843b46e436_a50c6a9e-c39e-4700-8395-51123ba0193f.html,,oral,LD50,"5,000 mg/kg bw",, "Fatty acids, C18-unsatd., dimers, compds. with coco alkylamines",68647-95-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee9fa2e7-d10f-4c5a-a519-87d418b0dbd0/documents/IUC5-06ce1e93-5e4e-4371-a047-977d4796381b_b1dab918-9e8f-476f-9d37-1b73d7416e9e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,12.5 mg/kg bw/day,, "Fatty acids, C18-unsatd., dimers, compds. with coco alkylamines",68647-95-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee9fa2e7-d10f-4c5a-a519-87d418b0dbd0/documents/IUC5-ff662a2d-5014-410f-ba8c-2eac74dc1fa3_b1dab918-9e8f-476f-9d37-1b73d7416e9e.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C18-unsatd., dimers, compds. with coco alkylamines",68647-95-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee9fa2e7-d10f-4c5a-a519-87d418b0dbd0/documents/IUC5-ff662a2d-5014-410f-ba8c-2eac74dc1fa3_b1dab918-9e8f-476f-9d37-1b73d7416e9e.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated",147853-32-5,"Based on read-across from Fatty acids, C18-unsaturated, dimers (CAS No. 61788-89-4):Oral: NOAEL (rat, subchronic) = 741 (males) and 855 (females) mg/kg bw/day (similar to OECD 408, GLP) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ef30106-bf0b-4dd2-b97e-ded4c85add1c/documents/IUC5-ee1a646b-2d02-4ffa-a750-1f6cc7460ef4_026c6bd2-b22e-4a21-8645-805ba1c6057a.html,,,,,, "Fatty acids, C18-unsatd., dimers, di-Me esters, hydrogenated",147853-32-5,"Oral: LD50 (rat) > 2000 mg/kg bw (experimental value), ≥ 5000 mg/kg bw (LD50 cut-off) (OECD 423, GLP) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ef30106-bf0b-4dd2-b97e-ded4c85add1c/documents/IUC5-efc0b449-3313-427b-b0ee-651cd56e26c8_026c6bd2-b22e-4a21-8645-805ba1c6057a.html,,,,,, "Fatty acids, C18-unsatd., dimers, ethoxylated",68551-92-8,"Oral:Subacute Toxicity Study 28days, oral, rat, OECD 422, up to 1000mg/kg bw/day tested: no adverse effects up to and including highest tested dosage, NOAEL ≥ 1000mg/kg bw/day (BASF SE, 2013, 85R0072/12X119)Dermal:No data availableInhalation:No data available ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ea2f6c7-45d3-4921-b483-ce39ba9a3e47/documents/IUC5-62d89e30-f50c-4a50-af6e-45d449c5c27a_ca51b11b-9fd3-4f0a-aa36-90ed06168147.html,,,,,, "Fatty acids, C18-unsatd., dimers, ethoxylated",68551-92-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ea2f6c7-45d3-4921-b483-ce39ba9a3e47/documents/IUC5-62d89e30-f50c-4a50-af6e-45d449c5c27a_ca51b11b-9fd3-4f0a-aa36-90ed06168147.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C18-unsatd., dimers, ethoxylated",68551-92-8,"Oral: - acute toxicity, oral, rat, Wistar, OECD 423, discriminating dose-value (female/male) 2000 mg/kg bw (no treatment related effects) (BASFSE, 2012, 10A0072/12X137) Dermal:- acute toxicity, dermal, rat, Wistar, OECD 402, dermal discriminating dose-value (female/male) 5000mg/kg bw (no treatment related effects) (BASFSE, 2012, 11A0072/12X138)Inhalation:- No information on acute inhalation available for Fatty acids, C18-unsatd., dimers, ethoxylated ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ea2f6c7-45d3-4921-b483-ce39ba9a3e47/documents/IUC5-9217d367-bc7a-4658-9265-4f4e51c11b7c_ca51b11b-9fd3-4f0a-aa36-90ed06168147.html,,,,,, "Fatty acids, C18-unsatd., dimers, ethoxylated",68551-92-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ea2f6c7-45d3-4921-b483-ce39ba9a3e47/documents/IUC5-9217d367-bc7a-4658-9265-4f4e51c11b7c_ca51b11b-9fd3-4f0a-aa36-90ed06168147.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C18-unsatd., dimers, ethoxylated",68551-92-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ea2f6c7-45d3-4921-b483-ce39ba9a3e47/documents/IUC5-9217d367-bc7a-4658-9265-4f4e51c11b7c_ca51b11b-9fd3-4f0a-aa36-90ed06168147.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Fatty acids, C18-unsatd., dimers, hydrogenated",68783-41-5,Based on read-across from a supporting substance (structural analogue) within a category approach:Oral: NOAEL (rat) = 741 (male) and 855 (female) mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/872a7746-4f44-4c1b-9deb-105f5f1aec51/documents/IUC5-8991a151-5897-4468-8d02-952f7e1d28a5_ecb9d20a-5fcd-4b6c-a8a9-fe498028d295.html,,,,,, "Fatty acids, C18-unsatd., dimers, hydrogenated",68783-41-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/872a7746-4f44-4c1b-9deb-105f5f1aec51/documents/IUC5-8991a151-5897-4468-8d02-952f7e1d28a5_ecb9d20a-5fcd-4b6c-a8a9-fe498028d295.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,741 mg/kg bw/day,,rat "Fatty acids, C18-unsatd., dimers, hydrogenated",68783-41-5,Oral: LD50 (rat) > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/872a7746-4f44-4c1b-9deb-105f5f1aec51/documents/IUC5-967b44d2-8494-4ffb-b4bf-a531b9a099ec_ecb9d20a-5fcd-4b6c-a8a9-fe498028d295.html,,,,,, "Fatty acids, C18-unsatd., dimers, hydrogenated",68783-41-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/872a7746-4f44-4c1b-9deb-105f5f1aec51/documents/IUC5-967b44d2-8494-4ffb-b4bf-a531b9a099ec_ecb9d20a-5fcd-4b6c-a8a9-fe498028d295.html,,oral,LD50,"5,000 mg/kg bw",, "Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters",68440-06-2,"RDT oral (OECD 408), rat NOAEL = 125 mg/kg bw/day (RA CAS 104-76-7), corresponding NAEL = 757.5 mg/kg bw/day for Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl estersRDT oral (OECD 408), rat NOAEL = 741/855 mg/kg bw/day (males/females) (RA CAS 61788-89-4), corresponding NAEL = 1037.4/1197 mg/kg bw/day (males/females) for Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8568cf1-adbf-454a-983a-731fb89d6f9d/documents/IUC5-27764df2-acfc-42cb-9d7e-c0e0e7ebff4e_60ef8a57-7c34-4962-938c-8e350e9e919a.html,,,,,, "Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters",68440-06-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8568cf1-adbf-454a-983a-731fb89d6f9d/documents/IUC5-27764df2-acfc-42cb-9d7e-c0e0e7ebff4e_60ef8a57-7c34-4962-938c-8e350e9e919a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "Fatty acids, C18-unsatd., dimers, hydrogenated, 2-ethylhexyl esters",68440-06-2,"Oral LD50 (OECD 423), rat = 5000 mg/kg bw Inhalation LC50 (OECD 436), rat > 5.3 mg/L air (RA CAS 68334-05-4) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8568cf1-adbf-454a-983a-731fb89d6f9d/documents/IUC5-446ecf5a-bc95-406c-b170-80259d2ea564_60ef8a57-7c34-4962-938c-8e350e9e919a.html,,,,,, "Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane",147256-33-5,"Oral: chronic NOAEL (rat, m/f) = 819.8-2312.2 mg/kg bw/day (based on read-across from Fatty acids, C18-unsatd., dimers and after correction for differences in molecular weight) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a43a81ab-d2f3-4901-bcf5-1732b13afd4e/documents/bfb738ce-74ac-433c-93ad-a135593dc745_611f2636-32f7-4927-96b3-44faf3f7d4c9.html,,,,,, "Fatty acids, C18-unsatd., dimers, mixed esters with oleic acid and trimethylolpropane",147256-33-5,"Oral (EU Method B.1), rat: LD50 > 2000 mg/kg bwInhalation (OECD 403), rat: LC50 > 5.3 mg/L air (based on read-across from CAS 68334-05-4) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a43a81ab-d2f3-4901-bcf5-1732b13afd4e/documents/1f43124b-5d99-46c7-9f35-0aa4182ad260_611f2636-32f7-4927-96b3-44faf3f7d4c9.html,,,,,, "Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C18-unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine",157707-73-8,"Based on existing datasets and structural ad chemical considerations, read-across from Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C-18 unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine to an available repeated dose toxicity study using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine is appropriate to meet the REACH Annex VII-IX data requirements. In a combined repeated dose and reproduction/developmental toxicity screening test conducted in the rat according to OECD Test Guideline 422, the NOAEL for systemic toxicity was determined to be 1000 mg/kg bw/day (i.e. the highest dose tested). The repeated dose toxicity of the substance will be characterised further based on read-across to a proposed 90-day oral repeated dose toxicity study in the rat (OECD Test Guideline 408) using Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/83dc27aa-4da9-42c9-898d-f62f5e1e7edf/documents/IUC5-f8c8ee35-aa92-4f3a-aec2-66a3567e3c5a_1a7d5514-b614-4388-adf0-715ceb7c59a2.html,,,,,, "Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C18-unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine",157707-73-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/83dc27aa-4da9-42c9-898d-f62f5e1e7edf/documents/IUC5-f8c8ee35-aa92-4f3a-aec2-66a3567e3c5a_1a7d5514-b614-4388-adf0-715ceb7c59a2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C18-unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine",157707-73-8,"The acute toxicity of Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C-18 unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine is low. The oral LD50 of the substance was determined to be > 2000 mg/kg bw in rats in an acute oral toxicity study (OECD Test Guideline 423) whereas the dermal LD50 of the substance was determined to be > 2000 mg/kg bw in rats in an acute dermal toxicity study (OECD Guideline 402). A waiver is proposed in accordance with Column 2 of Annex VIII of the REACH Regulation for acute inhalation toxicity on the basis that acute toxicity data are available for the oral and dermal routes. Inhalation is not predicted to be a significant route of exposure based on the physicochemical properties of the substance. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83dc27aa-4da9-42c9-898d-f62f5e1e7edf/documents/IUC5-849009c5-cab5-478a-b03e-2bd6cb65ad9c_1a7d5514-b614-4388-adf0-715ceb7c59a2.html,,,,,, "Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C18-unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine",157707-73-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83dc27aa-4da9-42c9-898d-f62f5e1e7edf/documents/IUC5-849009c5-cab5-478a-b03e-2bd6cb65ad9c_1a7d5514-b614-4388-adf0-715ceb7c59a2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C18-unsatd., dimers, oligomeric reaction products with fatty acids, C16-18 and C18-unsatd., branched and linear, tetraethylenepentamine and triethylenetetramine",157707-73-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83dc27aa-4da9-42c9-898d-f62f5e1e7edf/documents/IUC5-849009c5-cab5-478a-b03e-2bd6cb65ad9c_1a7d5514-b614-4388-adf0-715ceb7c59a2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine",68082-29-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e63ef06-1597-4a5c-a436-630f0ac3de09/documents/IUC5-8b389fbd-c9a6-42e0-8ef1-2bc09a6b8d3d_7e89a3c9-3081-4b94-bf98-cdaab7edd66e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine",68082-29-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e63ef06-1597-4a5c-a436-630f0ac3de09/documents/IUC5-8b389fbd-c9a6-42e0-8ef1-2bc09a6b8d3d_7e89a3c9-3081-4b94-bf98-cdaab7edd66e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine",68082-29-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e63ef06-1597-4a5c-a436-630f0ac3de09/documents/IUC5-0b1a1676-bc39-48b0-b461-a47da2043c4c_7e89a3c9-3081-4b94-bf98-cdaab7edd66e.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C18-unsatd., dimers, oligomeric reaction products with tall-oil fatty acids and triethylenetetramine",68082-29-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e63ef06-1597-4a5c-a436-630f0ac3de09/documents/IUC5-0b1a1676-bc39-48b0-b461-a47da2043c4c_7e89a3c9-3081-4b94-bf98-cdaab7edd66e.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol",68552-19-2," RDT oral (OECD 408), rat NOAEL = 741 and 855 mg/kg bw/day for males and females (RA CAS 61788-89-4) The NOAEL is corrected for differences in molecular weight between the source and target substance thus, the mass corrected NOAEL is 481.65 - 1820 mg/kg bw/day (males) and 555.75 - 2094.75 mg/kg bw/day (females) for Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol RDT oral (OECD 408), rat NOAEL = 125 (m/f) mg/kg bw/day (RA CAS 104-76-7) The NOAEL is corrected for differences in molecular weight between the source and target substance thus, the mass corrected NOAEL is 353.22 - 1330.34 mg/kg bw/day for Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd58ef82-cc4a-4059-800f-6cbc76a28c88/documents/8f3f3a57-0681-496d-aa54-8a312b09daae_116425f2-aabc-4f4e-b747-27f3c783a81b.html,,,,,, "Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol",68552-19-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd58ef82-cc4a-4059-800f-6cbc76a28c88/documents/8f3f3a57-0681-496d-aa54-8a312b09daae_116425f2-aabc-4f4e-b747-27f3c783a81b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,353.22 mg/kg bw/day,,rat "Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol",68552-19-2," Acute oral toxicity (OECD 423, GLP): LD50 > 2000 mg/kg bw (female, rat) (RA CAS 147256-33-5 and CAS 68440-06-2) Acute inhalation toxicity (OECD 436, GLP): LC50 > 5.3 mg/L air (male/female, rat) (RA CAS 68334-05-4) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd58ef82-cc4a-4059-800f-6cbc76a28c88/documents/48680211-0c6d-40d5-98c7-e18c7165e38e_116425f2-aabc-4f4e-b747-27f3c783a81b.html,,,,,, "Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynetrimethanol",162353-70-0,"RDT oral (OECD 408), rat: NOAEL = 741/855 (m/f) mg/kg bw/day (RA from CAS 61788-89-4), corresponding NAEL = 801/925 - 1587/1831 (m/f) mg/kg bw/day for Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanolRDT oral (OECD 422), rat: NOAEL ≥800 mg/kg bw/day (RA from CAS 77-99-6), corresponding NAEL = 3643 - 7214 mg/kg bw/day for Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ff44335-d961-4cc4-8b87-d384fe80cf6c/documents/824d2427-8e09-4eef-a3ed-1239ce939d06_4a5cfee7-b911-451f-954d-3eda16401890.html,,,,,, "Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynetrimethanol",162353-70-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ff44335-d961-4cc4-8b87-d384fe80cf6c/documents/824d2427-8e09-4eef-a3ed-1239ce939d06_4a5cfee7-b911-451f-954d-3eda16401890.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,741 mg/kg bw/day,,rat "Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynetrimethanol",162353-70-0,"Oral (OECD 423), rat: LD50 cut-off >5000 mg/kg bw (RA from CAS 147256-33-5)Inhalation (OECD 436), rat: LC50 >5.3 mg/L (air) (RA from CAS 68334-05-4)Dermal: Data waiving ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ff44335-d961-4cc4-8b87-d384fe80cf6c/documents/dc299e0e-2323-4891-b619-92749df61d16_4a5cfee7-b911-451f-954d-3eda16401890.html,,,,,, "Fatty acids, C18-unsatd., dimers, reaction products with polyethylenepolyamines",68410-23-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dca9008d-bbee-4c2a-9b32-b266eb3fb640/documents/IUC5-05f8be3d-13c0-4d4b-9d09-80a2e289e654_72034c87-ef5c-446f-977f-5354ab21bb0f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C18-unsatd., dimers, reaction products with polyethylenepolyamines",68410-23-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dca9008d-bbee-4c2a-9b32-b266eb3fb640/documents/IUC5-800ac3f7-9e4d-4b3d-8cea-8e9d0177d13c_72034c87-ef5c-446f-977f-5354ab21bb0f.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C18-unsatd., dimers, reaction products with polyethylenepolyamines",68410-23-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dca9008d-bbee-4c2a-9b32-b266eb3fb640/documents/IUC5-800ac3f7-9e4d-4b3d-8cea-8e9d0177d13c_72034c87-ef5c-446f-977f-5354ab21bb0f.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Esterification products of Fatty acids C18 unsaturated and triethanolamine,1474044-69-3,"The NOEL (No Observed Effect Level) for general toxicity in males was considered to be 1000 mg/kg bw/day, the highest dose level used. Due to finding of mucosal parakeratosis of the vagina in females at 1000 mg/kg bw/day, the NOEL for general toxicity in females was considered to be 300 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7ac9c4f-f497-4a8b-bd64-09ec6d37ccb1/documents/IUC5-64b1bed5-4772-46dc-849c-a0fe34be2457_c4dcbf74-6293-40ba-acdb-f5802345a1b4.html,,,,,, Esterification products of Fatty acids C18 unsaturated and triethanolamine,1474044-69-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7ac9c4f-f497-4a8b-bd64-09ec6d37ccb1/documents/IUC5-64b1bed5-4772-46dc-849c-a0fe34be2457_c4dcbf74-6293-40ba-acdb-f5802345a1b4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Esterification products of Fatty acids C18 unsaturated and triethanolamine,1474044-69-3,The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg bodyweight.The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7ac9c4f-f497-4a8b-bd64-09ec6d37ccb1/documents/IUC5-2a2f704f-d55d-4653-a11d-4736d9288cb6_c4dcbf74-6293-40ba-acdb-f5802345a1b4.html,,,,,, Esterification products of Fatty acids C18 unsaturated and triethanolamine,1474044-69-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7ac9c4f-f497-4a8b-bd64-09ec6d37ccb1/documents/IUC5-2a2f704f-d55d-4653-a11d-4736d9288cb6_c4dcbf74-6293-40ba-acdb-f5802345a1b4.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Esterification products of Fatty acids C18 unsaturated and triethanolamine,1474044-69-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7ac9c4f-f497-4a8b-bd64-09ec6d37ccb1/documents/IUC5-2a2f704f-d55d-4653-a11d-4736d9288cb6_c4dcbf74-6293-40ba-acdb-f5802345a1b4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C18-unsatd., phosphates",68604-99-9," Oral: The oral NOAEL for F0 systemic toxicity (rat, female) 1000 mg/kg bw/day (OECD-422) The oral NOAEL for F0 systemic toxicity (rat, male) 1000 mg/kg bw/day (OECD-422) Inhalation: Not a likely route of human exposure Dermal: Not a likely route of human exposure ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e42328c-94d0-4bdc-8951-e6fc434b51a4/documents/b074de9a-7c87-41c6-b453-78ee394b715c_cfd940f8-ebd7-4597-b628-9a0252fc8c7c.html,,,,,, "Fatty acids, C18-unsatd., phosphates",68604-99-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e42328c-94d0-4bdc-8951-e6fc434b51a4/documents/b074de9a-7c87-41c6-b453-78ee394b715c_cfd940f8-ebd7-4597-b628-9a0252fc8c7c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C18-unsatd., phosphates",68604-99-9," Oral exposure There is one good quality guideline compliant acute toxicity study via oral route (OECD 423 - Acute Toxic Class Method) conducted for the substance (van Sas, P.H.T., 2017). The purpose of the study was to evaluate the potential toxic effect of the test item PFA after single oral administration to rats. A limit dose of 2000 mg/kg body weight was used as starting dose. In this study the LD50 value of the substance in the female rats was estimated to be greater than 2000 mg/kg of body weight. In the study of van Sas, P.H.T., 2017 three female rats were gavaged with undiluted test substance at a dose level of 2000 mg/kg bw. No mortalities were observed during the test. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy. The post exposure period was 14 days. All animals showed expected gains in bodyweight. No abnormalities were noted at necropsy. The acute median lethal dose (LD50) of the test item in female Wistar rat was estimated to be greater than 2000 mg/kg bodyweight. As a conclusion, the results of the key study did not indicate this substance to be classified for acute toxicity via oral route.   Inhalation exposure In accordance with column 2 of REACH Annex VIII, testing by the inhalation route is not needed as the substance is classified as corrosive to the skin. In addition, PPEs are in use during the use of the substance so there is no risk of exposure to the substance via inhalation route. The PPEs and risk management measures are demonstrated in the CSR section 9 and 10.   Dermal exposure In accordance with column 2 of REACH Annex VIII the acute toxicity by dermal route is not needed as the substance is classified as corrosive to the skin. This is established in the study by van Sas (2017) described in CSR Section 5.4. Furthermore, The PPEs are worn to protect skin during the use of the substance. The risks for acute systemic effects via dermal route are adequately controlled with the risk management measures presented for long-term systemic effects (see CSR sections 9&10). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e42328c-94d0-4bdc-8951-e6fc434b51a4/documents/a49ef66e-12cd-4bdd-b375-59caea066f2e_cfd940f8-ebd7-4597-b628-9a0252fc8c7c.html,,,,,, "Fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines",85586-18-1, NOAEL systemic effects = 300 mg/kg bw/d; OECD guideline 422; Dunster JS (2011) NOAEL reproductive effects = >1000 mg/kg bw/d; OECD guideline 422; Dunster JS (2011) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b40b8cf1-3411-4e5e-878a-7dfcec41e682/documents/IUC5-e0433b3a-99f9-4485-ab27-17d217f70099_f992263b-27b7-4d71-b9a5-07b8aff6c808.html,,,,,, "Fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines",85586-18-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b40b8cf1-3411-4e5e-878a-7dfcec41e682/documents/IUC5-e0433b3a-99f9-4485-ab27-17d217f70099_f992263b-27b7-4d71-b9a5-07b8aff6c808.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Fatty acids, C18-unsatd., reaction products with acrylic acid and polyethylenepolyamines",85586-18-1,"Acute oral toxicity LD50 > 2500 mg/kg bw in the Sprague-Dawley CD strain rat; OECD guideline 423; Allen DJ, 2000.Acute dermal toxicity LD50 > 2000 mg/kg bw in the Sprague-Dawley rat (HdsHan:WIST); OECD guideline 402; Sanders A, 2010. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b40b8cf1-3411-4e5e-878a-7dfcec41e682/documents/IUC5-cf1f3839-8863-43b3-905b-5e5f2157da60_f992263b-27b7-4d71-b9a5-07b8aff6c808.html,,,,,, "Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products",1224966-15-7,"An oral 28-day repeated dose toxicity study according to OECD 407 on Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products resulted to a NOAEL of 80 mg/kg bw/day. The 90-day NOAEL from cross-reading to AAI-DETA is 10 mg/kg bw/d. At higher dose levels an increase of the presence of foamy macrophages in the lamina propria of the small intestines and mesenteric lymph nodes is observed. Other available data from the group of AAI substances, including 90 day studies in rat and dogs on a similar substance, indicate low repeated dose toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9f63ab1-7f6a-4095-a19e-8d519cbbda47/documents/IUC5-8e84bf83-5c1d-4758-a7e4-738fb859b5d3_3592996b-f9f2-45b5-be4e-7932a15a51ee.html,,,,,, "Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products",1224966-15-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9f63ab1-7f6a-4095-a19e-8d519cbbda47/documents/IUC5-8e84bf83-5c1d-4758-a7e4-738fb859b5d3_3592996b-f9f2-45b5-be4e-7932a15a51ee.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products",1224966-15-7,Oral LD50 = 4000 mg/kg in rat; dermal LD50 > 2000 mg/kg bw in rat. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9f63ab1-7f6a-4095-a19e-8d519cbbda47/documents/IUC5-e0941fb5-af94-4baf-bca6-89b782352d83_3592996b-f9f2-45b5-be4e-7932a15a51ee.html,,,,,, "Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products",1224966-15-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9f63ab1-7f6a-4095-a19e-8d519cbbda47/documents/IUC5-e0941fb5-af94-4baf-bca6-89b782352d83_3592996b-f9f2-45b5-be4e-7932a15a51ee.html,,oral,LD50,"4,000 mg/kg bw",adverse effect observed, "Fatty acids, C18 unsaturated, reaction product with ammonia-ethanolamine reaction by-products",1224966-15-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9f63ab1-7f6a-4095-a19e-8d519cbbda47/documents/IUC5-e0941fb5-af94-4baf-bca6-89b782352d83_3592996b-f9f2-45b5-be4e-7932a15a51ee.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C18 unsat, reaction products with pentaethylenehexamine, acetate salts",1474044-67-1,"Read-across to the findings of a sub-acute repeated dose study conducted according to OECD Test Guideline 422 using Fatty acids C18 unsat, reaction products with pentaethylenehexamine is considered appropriate to characterise the repeated dose toxicity of the substance and meet the REACH Annex VII-IX data requirements. In the study, the NOAEL for sub-acute repeated dose toxicity was 300 mg/kg bw/day (i.e. the highest dose tested). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/95b20cf2-f928-4c5c-bc2e-9aa251e16dab/documents/IUC5-45960192-d288-476c-a64a-b99d7aa4cbfa_b4311966-b4cf-41b6-ab12-89da544e76b9.html,,,,,, "Fatty acids, C18 unsat, reaction products with pentaethylenehexamine, acetate salts",1474044-67-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/95b20cf2-f928-4c5c-bc2e-9aa251e16dab/documents/IUC5-45960192-d288-476c-a64a-b99d7aa4cbfa_b4311966-b4cf-41b6-ab12-89da544e76b9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Fatty acids, C18 unsat, reaction products with pentaethylenehexamine, acetate salts",1474044-67-1,"A modern, GLP-and guideline-compliant acute oral toxicity study is available for the Registered Substance. A modern, GLP-and guideline-compliant dermal absorption study is available for the read-across substance [Fatty acid C18 unsat, reaction products with diethylenetriamine, acetate salts]. A waiver is proposed for acute inhalation toxicity based on the availability of data for two other exposure routes and based on the physicochemical properties and use pattern of the substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95b20cf2-f928-4c5c-bc2e-9aa251e16dab/documents/IUC5-e187ac54-aa5c-4551-99b4-1b7d67cd1e86_b4311966-b4cf-41b6-ab12-89da544e76b9.html,,,,,, "Fatty acids, C18 unsat, reaction products with pentaethylenehexamine, acetate salts",1474044-67-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95b20cf2-f928-4c5c-bc2e-9aa251e16dab/documents/IUC5-e187ac54-aa5c-4551-99b4-1b7d67cd1e86_b4311966-b4cf-41b6-ab12-89da544e76b9.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "Fatty acids, C18 unsat, reaction products with pentaethylenehexamine, acetate salts",1474044-67-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95b20cf2-f928-4c5c-bc2e-9aa251e16dab/documents/IUC5-e187ac54-aa5c-4551-99b4-1b7d67cd1e86_b4311966-b4cf-41b6-ab12-89da544e76b9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C18-unsatd., trimers",68937-90-6,Based on read-across from a supporting substance (structural analogue) within a category approach:Oral: NOAEL (rat) = 741 (male) and 855 (female) mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8eda38c-a478-43ef-8cd7-7b2e396f90b9/documents/IUC5-60f81e71-8c6c-42c2-ae6c-fe4199be19da_69af7b01-fe6d-43ca-bab7-68b353ef9faa.html,,,,,, "Fatty acids, C18-unsatd., trimers",68937-90-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8eda38c-a478-43ef-8cd7-7b2e396f90b9/documents/IUC5-60f81e71-8c6c-42c2-ae6c-fe4199be19da_69af7b01-fe6d-43ca-bab7-68b353ef9faa.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,741 mg/kg bw/day,,rat "Fatty acids, C18-unsatd., trimers",68937-90-6,Based on read-across following a category approach: Oral: LD50 (rat) > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8eda38c-a478-43ef-8cd7-7b2e396f90b9/documents/IUC5-28d2302f-6ee5-4916-9aeb-c843f16f1301_69af7b01-fe6d-43ca-bab7-68b353ef9faa.html,,,,,, "Fatty acids, C18-unsatd., trimers",68937-90-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8eda38c-a478-43ef-8cd7-7b2e396f90b9/documents/IUC5-28d2302f-6ee5-4916-9aeb-c843f16f1301_69af7b01-fe6d-43ca-bab7-68b353ef9faa.html,,oral,LD50,"5,000 mg/kg bw",, "Fatty acids, C18-unsatd., trimers, 2-ethylhexyl esters",173832-46-7,"Based on read-across from 2-ethylhexanol (CAS 104-76-7), which is a hydrolysis product of the target substance, no hazard was identified.Oral: chronic NOAEL (rat, m/f) = 934.5-1136.5 mg/kg bw/day (based on read-across from 2-ethylhexanol and after correction for differences in molecular weight) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db02fa96-708e-4fa9-ae7d-47ac6eedd361/documents/IUC5-41594bdd-bd53-4a87-bb0f-6606eee0ccbd_36cbd1fa-5122-4740-8583-0ad17f6615c8.html,,,,,, "Fatty acids, C18-unsatd., trimers, 2-ethylhexyl esters",173832-46-7,"Oral (OECD 423), rat: LD50 > 5000 mg/kg bw/dayInhalation (OECD 436), rat: LC50 > 5.3 mg/mL (based on read-across from CAS 68334-05-4)Dermal: no study available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db02fa96-708e-4fa9-ae7d-47ac6eedd361/documents/IUC5-e4f904fe-a620-45ef-ab62-90f39dace7af_36cbd1fa-5122-4740-8583-0ad17f6615c8.html,,,,,, "Pentaerythritol tetraesters of n-C5, n-C7, n-C8, i-C9 and n-C10 fatty acids",156558-98-4," HATCOL 5236: Subacute 28-day oral toxicity - NOAEL  150 - 1000 mg/kg/day in male and female Wistar rats. HATCOL 3344: Subacute 28-day oral toxicity - NOAEL 1000 mg/kg/day in male and female Wistar rats. HATCOL 3331: Subacute 28-day oral toxicity - NOAEL 150 mg/kg/day in male and female Wistar rats. Reaction product of pentaerythritol and trimethylolpropane with n-pentanoic acid, 2-methylbutyric acid, n-heptanoic acid, 3,5,5-trimethylhexanoic acid, n-octanoic acid and n-decanoic acid: Repeated dose toxicity: Oral NOAEL (rat, m/f): = 300 mg/kg bw/day (OECD 408, GLP, analogue approach). Pentaerythritol ester of pentanoic acids and isononanoic acid: Oral NOAEL (rat, f): 500 mg/kg bw/day (OECD 407, GLP, analogue approach). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/220838b4-251d-4a5f-92b5-11d52dd11220/documents/IUC5-6c9bc982-5581-4bd6-8366-818f8b47901c_06780a10-4d82-4987-bbdd-38a43aa43169.html,,,,,, "Pentaerythritol tetraesters of n-C5, n-C7, n-C8, i-C9 and n-C10 fatty acids",156558-98-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/220838b4-251d-4a5f-92b5-11d52dd11220/documents/IUC5-6c9bc982-5581-4bd6-8366-818f8b47901c_06780a10-4d82-4987-bbdd-38a43aa43169.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat "Pentaerythritol tetraesters of n-C5, n-C7, n-C8, i-C9 and n-C10 fatty acids",156558-98-4," HATCOL 5236: Acute Oral Toxicity: LD50 >2000 mg/kg bw in male & female Wistar rats. Acute Dermal Toxicity: LD50 >2000 mg/kg bw in male & female Wistar rats. HATCOL 3344: Acute Oral Toxicity: LD50 >2000 mg/kg bw in male & female Wistar rats. Acute Dermal Toxicity: LD50 >2000 mg/kg bw in male & female Wistar rats. HATCOL 3331: Acute Oral Toxicity: LD50 >2000 mg/kg bodyweight in male and female Wistar rats. Acute Dermal Toxicity: LD50 >2000 mg/kg bodyweight in male and female Wistar rats. Reaction product of pentaerythritol and trimethylolpropane with n-pentanoic acid, 2-methylbutyric acid, n-heptanoic acid, 3,5,5-trimethylhexanoic acid, n-octanoic acid and n-decanoic acid Acute Oral Toxicity: LD50 > 5000 mg/kg bodyweight in male and female rats Acute Dermal Toxicity: LD50 > 2000 mg/kg bodyweight in male and female rats ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/220838b4-251d-4a5f-92b5-11d52dd11220/documents/IUC5-68ddbb9a-334e-4639-a3f2-7c254fe937bf_06780a10-4d82-4987-bbdd-38a43aa43169.html,,,,,, "Pentaerythritol tetraesters of n-C5, n-C7, n-C8, i-C9 and n-C10 fatty acids",156558-98-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/220838b4-251d-4a5f-92b5-11d52dd11220/documents/IUC5-68ddbb9a-334e-4639-a3f2-7c254fe937bf_06780a10-4d82-4987-bbdd-38a43aa43169.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Pentaerythritol tetraesters of n-C5, n-C7, n-C8, i-C9 and n-C10 fatty acids",156558-98-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/220838b4-251d-4a5f-92b5-11d52dd11220/documents/IUC5-68ddbb9a-334e-4639-a3f2-7c254fe937bf_06780a10-4d82-4987-bbdd-38a43aa43169.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C6-19-branched, calcium salts",68409-80-3,"No repeated dose toxicity study with fatty acids, C6-19-branched, calcium salts is available, thus the repeated dose toxicity will be addressed with existing data on the individual moieties calcium and fatty acids, C6-19-branched, represented by neodecanoic acid. In relevant and reliable repeated dose toxicity studies as well as supporting studies for both moieties of fatty acids, C6-19-branched, calcium salts, there were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b688ec0b-c1c1-4253-b50b-1af3b9b24f85/documents/87eca8e1-bd9d-4aec-96c3-378c63174207_b81a78d8-6fde-4142-89e7-c8d0da2a1a8b.html,,,,,, "Fatty acids, C6-19-branched, calcium salts",68409-80-3,"The experimentally measured oral LD50 for fatty acids, C6-19-branched, calcium salts is > 2000 mg/kg bw, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral toxicity as well as for specific target organ toxicity, single exposure (STOT SE). No acute dermal toxicity studies with fatty acids, C6-19-branched, calcium salts are available, thus the acute toxicity will be addressed with existing data on the dissociation products calcium and neodecanoate. Signs of acute dermal toxicity are not expected for fatty acids, C6-19-branched, calcium salts, since the LD50 for the constituent fatty acids, C6-19-branched, represented by its structural analogue neodecanoic acid, is above 2000 mg/kg bw and the physicochemical properties of the calcium cation do not suggest a significant rate of absorption through the skin. Based on the above given information fatty acids, C6-19-branched, calcium salts is not expected to show any acute toxic effects via dermal route and does not require a classification for acute dermal toxicity (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006).   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b688ec0b-c1c1-4253-b50b-1af3b9b24f85/documents/9335d89c-85b4-4cad-86e3-0aaa7d8d5c4b_b81a78d8-6fde-4142-89e7-c8d0da2a1a8b.html,,,,,, "Fatty acids, C6-19-branched, calcium salts",68409-80-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b688ec0b-c1c1-4253-b50b-1af3b9b24f85/documents/9335d89c-85b4-4cad-86e3-0aaa7d8d5c4b_b81a78d8-6fde-4142-89e7-c8d0da2a1a8b.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C6-19-branched, copper(2+) salts",68308-19-0,"No repeated dose toxicity study with fatty acids, C6-19-branched, copper(2+) salts is available, thus the repeated dose toxicity will be addressed with existing data on the individual moieties copper and fatty acids, C6-19-branched, represented by neodecanoic acid. In relevant and reliable repeated dose toxicity studies as well as supporting studies for both moieties of fatty acids, C6-19-branched, copper(2+) salts, there were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb40f104-6e46-4e07-aa25-b8d1042f1df7/documents/a2e92201-70bc-45f4-ab37-105728826832_60aa7c3a-9591-4da2-b115-a020a8fcd854.html,,,,,, "Fatty acids, C6-19-branched, copper(2+) salts",68308-19-0,"The experimentally measured oral LD50 for fatty acids, C6-19-branched, copper(2+) salts is >2000 mg/kg bw, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral toxicity as well as for specific target organ toxicity, single exposure (STOT SE). No acute dermal toxicity studies with fatty acids, C6-19-branched, copper(2+) salts are available, thus the acute toxicity will be addressed with existing data on the dissociation products copper and fatty acids, C6-19-branched. Signs of acute dermal toxicity are not expected for fatty acids, C6-19-branched, copper(2+) salts, since the LD50 for both constituents (copper and fatty acids, C6-19-branched, represented by its structural analogue neodecanoic acid) is above 2000 mg/kg bw. Based on the above given information fatty acids, C6-19-branched, copper(2+) salts is not expected to show any acute toxic effects via dermal route and does not require a classification for acute dermal toxicity (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb40f104-6e46-4e07-aa25-b8d1042f1df7/documents/c63a7911-d278-4bf3-b3e0-751d8dcd382e_60aa7c3a-9591-4da2-b115-a020a8fcd854.html,,,,,, "Fatty acids, C6-19-branched, copper(2+) salts",68308-19-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb40f104-6e46-4e07-aa25-b8d1042f1df7/documents/c63a7911-d278-4bf3-b3e0-751d8dcd382e_60aa7c3a-9591-4da2-b115-a020a8fcd854.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C6-19-branched, zinc salts",68551-44-0,"In a GLP conform OECD 423 study, the acute oral LD50 value of the test item Fatty acids, C6-19-branched, zinc salts was found to be > 2000 mg/kg bw in female Han:WIST rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ab21cf6-97de-4110-8134-6b8acd87ef0f/documents/IUC5-2505202e-753b-4fc6-9d80-7b8cb322cc8f_fe2c4566-f470-4e82-8f75-9f632687d197.html,,,,,, "Fatty acids, C6-19-branched, zinc salts",68551-44-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ab21cf6-97de-4110-8134-6b8acd87ef0f/documents/IUC5-2505202e-753b-4fc6-9d80-7b8cb322cc8f_fe2c4566-f470-4e82-8f75-9f632687d197.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. residues",102242-52-4,NOAEL subchronic toxicity rat > 250 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3453adc1-66b2-4af5-bf9a-21c271bb1beb/documents/IUC5-c0504de7-8e77-4950-83fd-449246ac5727_1d853f1f-cf81-4bcf-9842-5a1b109bae5b.html,,,,,, "Fatty acids, C6-24 and C6-24-unsatd., Me esters, distn. residues",102242-52-4,LD 50 = greater than 2000 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3453adc1-66b2-4af5-bf9a-21c271bb1beb/documents/IUC5-aa4c7561-d8f3-40d4-aa74-57b119754fa3_1d853f1f-cf81-4bcf-9842-5a1b109bae5b.html,,,,,, "Fatty acids, C8-10 (even numbered), 2-ethylhexyl esters",649747-80-8,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ffa95040-9a91-4d50-b27c-6be140b7b2c3/documents/IUC5-2be39757-41f7-4a49-b03d-300254e7bacb_3333fdf0-2685-4108-8727-fcda53b8063b.html,,,,,, "Fatty acids, C8-10 (even numbered), 2-ethylhexyl esters",649747-80-8,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ffa95040-9a91-4d50-b27c-6be140b7b2c3/documents/IUC5-b7765b29-fc70-4101-8017-28197aa32203_3333fdf0-2685-4108-8727-fcda53b8063b.html,,,,,, "Fatty acids, C8-10 (even numbered), 3-methylbutyl esters",1365095-43-7,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c219780-0048-4927-b470-a941146c9d0e/documents/IUC5-2be39757-41f7-4a49-b03d-300254e7bacb_73af68db-1f34-4730-b4e7-92bf76536a7e.html,,,,,, "Fatty acids, C8-10 (even numbered), 3-methylbutyl esters",1365095-43-7,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c219780-0048-4927-b470-a941146c9d0e/documents/IUC5-b7765b29-fc70-4101-8017-28197aa32203_73af68db-1f34-4730-b4e7-92bf76536a7e.html,,,,,, "Fatty acids, C8-10, C12-18-alkyl esters",95912-86-0,NOAEL systemic= 300 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2f6be1a-7051-4bb9-9443-e89c16cffb7a/documents/cf01eb1b-da6d-4d82-bf4d-31c7c42b5efc_3c438b6e-c538-4a87-97a1-7bddb605eec9.html,,,,,, "Fatty acids, C8-10, C12-18-alkyl esters",95912-86-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2f6be1a-7051-4bb9-9443-e89c16cffb7a/documents/cf01eb1b-da6d-4d82-bf4d-31c7c42b5efc_3c438b6e-c538-4a87-97a1-7bddb605eec9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Fatty acids, C8-10, C12-18-alkyl esters",95912-86-0,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2f6be1a-7051-4bb9-9443-e89c16cffb7a/documents/2ff6b75c-ea9f-48e8-9e3c-5aabb21bd070_3c438b6e-c538-4a87-97a1-7bddb605eec9.html,,,,,, "Fatty acids, C8-10, C8-10 alkyl esters",129677-93-6," Oral: - similar to OECD 408, rat NOAEL = 800 mg/kg bw/day (read-across) - according to OECD 422, rat NOAEL >= 1000 mg/kg bw/day (read-across) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/49509654-6459-4bac-86fc-ddf3ab824736/documents/IUC5-952b0974-25b4-4f39-8b54-0982017bd461_dd61b164-848a-4720-8c5f-65bd099c9042.html,,,,,, "Fatty acids, C8-10, C8-10 alkyl esters",129677-93-6,Oral (read-across): LD50 > 4300 mg/kg bw Inhalation (read-across): LC50 > 5.7 mg/LDermal (read-across): LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/49509654-6459-4bac-86fc-ddf3ab824736/documents/IUC5-0d9a65e7-6c8c-432c-bde6-4cbf58578cf1_dd61b164-848a-4720-8c5f-65bd099c9042.html,,,,,, "Fatty acids, C8-10, Me esters",85566-26-3,"OECD 422, rat: NOAEL = 1000 mg/kg bw/d of the read across substance methyl laurate. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e19e452f-5b39-4c85-a47f-ea6dc2948384/documents/IUC5-b4045343-b467-461b-887e-3702cfd4c456_d148968f-3cf8-4591-9533-a73082fca797.html,,,,,, "Fatty acids, C8-10, Me esters",85566-26-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e19e452f-5b39-4c85-a47f-ea6dc2948384/documents/IUC5-b4045343-b467-461b-887e-3702cfd4c456_d148968f-3cf8-4591-9533-a73082fca797.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,740 mg/kg bw/day,, "Fatty acids, C8-10, Me esters",85566-26-3,"All available acute oral toxicity studies within this category resulted in acute oral LD50 in rats greater than 2000 mg/kg bw.Studies on acute oral toxicity were available for the following members of this category (CAS No.): 111-11-5, 111-82-0, 112-39-0, 112-61-8, 91051-34-2, 61788-59-8, 106-70-7, 112-63-0.The NOAEC for 111-82-0 was found to be > 5 mg/L air.No acute dermal toxicity studies were available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e19e452f-5b39-4c85-a47f-ea6dc2948384/documents/IUC5-bb1cbd9d-78d2-4029-a44e-81830686de39_d148968f-3cf8-4591-9533-a73082fca797.html,,,,,, "Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane",95912-89-3,WoE based on available data from surrogate substances:All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3903e4f-6d1a-44a6-bfd6-7f8b60c58b34/documents/IUC5-c474d123-d6a1-40a7-8fd4-29e3e4da07ce_c99c2982-9cb5-4396-802a-a9935f3e211a.html,,,,,, "Fatty acids, C8-10, mixed esters with adipic acid and trimethylolpropane",95912-89-3,All available acute oral toxicity studies within this category resulted in acute oral LD50 > 5000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.05 mg/L. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3903e4f-6d1a-44a6-bfd6-7f8b60c58b34/documents/IUC5-583621d5-9bb4-48ce-8e87-ce7e790b3f02_c99c2982-9cb5-4396-802a-a9935f3e211a.html,,,,,, "Fatty acids, C8-10, mixed esters with neopentyl glycol and trimethylolpropane",97281-24-8,"Repeated dose toxicity: oral (OECD 407), rat; NOAEL (m/f) =1450/1613 mg/kg bw/day (RA from CAS 189120-64-7) ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a21afd9-af3e-4248-bfcf-97c4a61736a6/documents/b88eb70c-fcfa-4eeb-9281-9ff8aba88637_652a004f-4098-4af9-83be-d69afd2f2211.html,,,,,, "Fatty acids, C8-10, mixed esters with neopentyl glycol and trimethylolpropane",97281-24-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a21afd9-af3e-4248-bfcf-97c4a61736a6/documents/b88eb70c-fcfa-4eeb-9281-9ff8aba88637_652a004f-4098-4af9-83be-d69afd2f2211.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,450 mg/kg bw/day",,rat "Fatty acids, C8-10, mixed esters with neopentyl glycol and trimethylolpropane",97281-24-8,Oral (OECD 401): LD50 >2000 mg/kg bwInhalation (OECD 436): LC50 >5.22 mg/L (RA from CAS 68855-18-5)Dermal: Waiving ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a21afd9-af3e-4248-bfcf-97c4a61736a6/documents/ce269e91-2a1d-4594-af0b-ca1618164de9_652a004f-4098-4af9-83be-d69afd2f2211.html,,,,,, "Fatty acids, C8-10, octyl esters",91031-98-0,"NOAEL (28 days, rat): 1000 mg/kg bw/dayNOAEL (90 days, rat): 800 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d35faaa-8fe4-4622-b3b1-2b0bcc8827cc/documents/IUC5-79071632-3864-457b-b6e9-501b61f3f656_c6dfeb38-ad64-4644-b748-6a5f6f10737a.html,,,,,, "Fatty acids, C8-10, octyl esters",91031-98-0,"Acute toxicity: Oral LD50 (rat, m): > 5000mg/kg bw (similar to OECD 401, analogue approach)Acute toxicity: Inhalation LC50 (rat, m/f) > 5.3 mg/L (OECD 436; analogue approach)Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, analogue approach) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d35faaa-8fe4-4622-b3b1-2b0bcc8827cc/documents/IUC5-cfe486df-5207-4d82-b699-dcd1c337327e_c6dfeb38-ad64-4644-b748-6a5f6f10737a.html,,,,,, "Fatty acids, C8-10, oxybis(2-hydroxy-3,1-propanediyl) esters",92044-91-2,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.   Combined repeated dose and reproduction / developmental screening (OECD 422): NOAEL = 1000 mg/kg bw/day RA from source substance (CAS 63705-03-3)   Subacute oral repeated dose toxicity (OECD 401): NOAEL = 1800 mg/kg bw/day RA from source substance (CAS 130905-60-1) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises two adequate and reliable studies (RL1 and RL2) from reference substances with similar structure. Read-across is justified based on structural similarities and similar chemical behaviour. The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.6, in accordance with Annex XI, 1.5, of Regulation (EC) No. 1907/2006. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7f822ac-d7f1-4739-a7ac-a289f5859866/documents/ec27b3e6-4b7b-48d8-8af8-550d273dd5af_17c4f9e0-75db-4e90-a102-f0f3506ca830.html,,,,,, "Fatty acids, C8-10, oxybis(2-hydroxy-3,1-propanediyl) esters",92044-91-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7f822ac-d7f1-4739-a7ac-a289f5859866/documents/ec27b3e6-4b7b-48d8-8af8-550d273dd5af_17c4f9e0-75db-4e90-a102-f0f3506ca830.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C8-10, oxybis(2-hydroxy-3,1-propanediyl) esters",92044-91-2,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.   Acute oral toxicity (OECD 401): LD50 > 2000 mg/kg bw RA from source substance (CAS 130905-60-1)   Acute oral toxicity (similar to OECD 401): LD50 > 5000 mg/kg bw RA from source substance (CAS 63705-03-3) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises two adequate and reliable studies (RL2) from reference substances with similar structure. Read-across is justified based on structural similarities and similar chemical behaviour. The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7f822ac-d7f1-4739-a7ac-a289f5859866/documents/3810b040-02b1-46dc-b639-3f16ac048ba3_17c4f9e0-75db-4e90-a102-f0f3506ca830.html,,,,,, "Fatty acids, C8-10, tetraesters with pentaerythritol",85586-24-9,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category. All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75570b9f-2d3e-43d1-9df8-b917dd890736/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_edc30b33-dbe2-4b19-915e-3b45314b0173.html,,,,,, "Fatty acids, C8-10, tetraesters with pentaerythritol",85586-24-9,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75570b9f-2d3e-43d1-9df8-b917dd890736/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_edc30b33-dbe2-4b19-915e-3b45314b0173.html,,,,,, "Fatty acids, C8-10, triesters with trimethylolpropane",91050-89-4,All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48977641-3765-4bea-9727-1badee47efa6/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_a23165fc-7216-45b9-9f1a-7495ab1b4292.html,,,,,, "Fatty acids, C8-10, triesters with trimethylolpropane",91050-89-4,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48977641-3765-4bea-9727-1badee47efa6/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_a23165fc-7216-45b9-9f1a-7495ab1b4292.html,,,,,, "Fatty acids, C8-10, zinc salts",91051-00-2," No repeated dose toxicity study with Fatty acids, C8-10, zinc salts is available, thus the repeated dose toxicity will be addressed with existing data on the moieties liberated upon dissolution zinc and fatty acids, C8-10. In relevant and reliable repeated dose toxicity studies for the moiety zinc of Fatty acids, C8-10, zinc salts, and in peer-reviewed publicly available assessment reports for the moiety fatty acids, C8-10, there were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a08c9f4b-62f4-451b-8367-9cda2caa8164/documents/IUC5-e3cff102-8644-4442-8722-e3b8333519e2_c9f83e66-4d8e-49c2-909a-84f2f8ec1f2a.html,,,,,, "Fatty acids, C8-10, zinc salts",91051-00-2," No acute toxicity studies with Fatty acids, C8-10, zinc salts are available, thus the acute toxicity will be addressed with existing data on the dissociation products zinc and fatty acids, C8-10 and with existing data on structurally similar zinc salts of fatty acids.   Signs of acute oral and dermal toxicity are not expected for Fatty acids, C8 -10, zinc salts, since the moiety zinc has not shown signs of acute oral toxicity in experimental testing and the acute dermal toxicity for the moiety zinc can be considered low in view of the poor absorption by this route. For the moiety fatty acids, C8-10 there were no toxicological findings reported in peer-reviewed publicly available assessment reports, neither by the oral nor by the dermal route.   The calculated oral and dermal LD50 for fatty acids, C8-10, zinc salts is > 2000mg/kg, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral and dermal toxicity as well as for specific target organ toxicity, single exposure (STOT SE). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a08c9f4b-62f4-451b-8367-9cda2caa8164/documents/IUC5-159cb0dc-30bd-4065-b854-74ef27c459bc_c9f83e66-4d8e-49c2-909a-84f2f8ec1f2a.html,,,,,, "Fatty acids, C8-10, zinc salts",91051-00-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a08c9f4b-62f4-451b-8367-9cda2caa8164/documents/IUC5-159cb0dc-30bd-4065-b854-74ef27c459bc_c9f83e66-4d8e-49c2-909a-84f2f8ec1f2a.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C8-14, triesters with trimethylolpropane",95009-31-7,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.   All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/abe3ea9d-7902-4f32-82fa-5bd2783ca232/documents/IUC5-3bee8ea8-9bb7-426f-b4e4-c21647768fee_22542ca0-1b81-4ab8-bf5a-9ee10a4000b8.html,,,,,, "Fatty acids, C8-14, triesters with trimethylolpropane",95009-31-7,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category. All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abe3ea9d-7902-4f32-82fa-5bd2783ca232/documents/IUC5-c851a21c-3fff-4afd-9313-51003e688e88_22542ca0-1b81-4ab8-bf5a-9ee10a4000b8.html,,,,,, "Fatty acids, C8-16",85631-26-1,"Reliable studies on oral repeated dose toxicity are available for the following category members:Subchronic: NOAEL oral = ca. 5000 mg/kg bw/d; CAS# 143-07-7, C12 (Fitzhugh 1960)Subchronic: NOAEL oral = 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao 2002)No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/db44d49c-9956-461d-b176-e9c6a21dedd9/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_b3294572-9e7b-4e77-ab08-862076063d48.html,,,,,, "Fatty acids, C8-16",85631-26-1,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/db44d49c-9956-461d-b176-e9c6a21dedd9/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_b3294572-9e7b-4e77-ab08-862076063d48.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C8-16",85631-26-1,"Acute toxicity:- oral: LD50 >5000 mg/kg bw (OECD 401; Analogy CAS 124-07-2, CAS 143-07-7);- inhalative: LC50 >0.1521 mg/L (IHT; Analogy CAS 124-07-2);- dermal: LD50 > 2000 mg/kg bw (Analogy CAS 57-11-4); ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db44d49c-9956-461d-b176-e9c6a21dedd9/documents/IUC5-d6221f1c-af4a-45f5-9e13-ea19c9d39926_b3294572-9e7b-4e77-ab08-862076063d48.html,,,,,, "Fatty acids, C8-16(even numbered), 2-ethylhexyl esters",135800-37-2,"All available subacute and subchronic oral repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/d or greater. Studies on oral subacute repeated dose toxicity were available for the following category members (CAS#): 110-27-0, 135800-37-2 and 91031-48-0.Studies on oral subchronic repeated dose toxicity were available for the following category members (CAS#): 111-62-6, 163961-32-8 and for the metabolite 2-ethylhexanol (104-76-7). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1779e6a-9325-4319-aef9-03efc3c0175f/documents/IUC5-4351b27b-eb25-4ade-8cbb-81d5acf1990a_2fc6a0a9-3827-4ace-87d2-45724a3510a2.html,,,,,, "Fatty acids, C8-16(even numbered), 2-ethylhexyl esters",135800-37-2,"All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. Studies on acute oral toxicity were available for the following members of this category (CAS#): 10233-13-3, 110-27-0, 142-91-6, 112-11-8, 544-35-4, 26399-02-0, 135800-37-2, 91031-48-0, 29806-73-3, 123-95-5, 163961-32-8.All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. Studies on acute dermal toxicity were available for the following members of this category (CAS#): 544-35-4, 163961-32-8Studies on acute inhalation toxicity were available for the following members of this category (CAS#): 10233-13-3, 26399-02-0, 135800-37-2, 67762-63-4 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1779e6a-9325-4319-aef9-03efc3c0175f/documents/IUC5-d62f7d51-fec9-4635-a85e-633a309be381_2fc6a0a9-3827-4ace-87d2-45724a3510a2.html,,,,,, "Fatty acids, C8-18",90990-08-2,"Reliable studies on oral repeated dose toxicity are available for the following category members:Subchronic: NOAEL oral = ca. 5000 mg/kg bw/d; CAS# 143-07-7, C12 (Fitzhugh 1960)Subchronic: NOAEL oral = 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao 2002)No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f529427-b495-46cb-85de-a28d81d04d3f/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_71d390c7-7e98-48a8-9872-3a9131813156.html,,,,,, "Fatty acids, C8-18",90990-08-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f529427-b495-46cb-85de-a28d81d04d3f/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_71d390c7-7e98-48a8-9872-3a9131813156.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C8-18",90990-08-2,Acute toxicity:- oral: LD50 >5000 mg/kg bw (OECD 401);- inhalative: LC50 >0.1521 mg/L (IHT; Analogy CAS 124-07-2);- dermal: LD50 > 2000 mg/kg bw (Analogy CAS 57-11-4); ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f529427-b495-46cb-85de-a28d81d04d3f/documents/IUC5-7705410f-db16-4a1a-8c3f-307d967177d9_71d390c7-7e98-48a8-9872-3a9131813156.html,,,,,, "Fatty acids, C8-18 and C18-unsatd., esters with neopentyl glycol",85186-86-3,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category. All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea2d0167-d37e-4eb3-9737-30aa90e4e2c7/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_64d2c8c8-027e-410a-b3ba-fd6fdd771082.html,,,,,, "Fatty acids, C8-18 and C18-unsatd., esters with neopentyl glycol",85186-86-3,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea2d0167-d37e-4eb3-9737-30aa90e4e2c7/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_64d2c8c8-027e-410a-b3ba-fd6fdd771082.html,,,,,, "Fatty acids, C8-18 and C18-unsatd., esters with trimethylolpropane",85186-89-6,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category.   All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b31e001-316b-451c-9e80-82d056fbead4/documents/IUC5-3bee8ea8-9bb7-426f-b4e4-c21647768fee_2f5bf390-f606-4e7e-95a8-e421837f78ad.html,,,,,, "Fatty acids, C8-18 and C18-unsatd., esters with trimethylolpropane",85186-89-6,"The hazard assessment is based on the data currently available. New studies with the registered substance and/or other member substances of the polyol esters category will be conducted in the future. The finalised studies will be included in the technical dossier as soon as they become available and the hazard assessment will be re-evaluated accordingly. For further details, please refer to the category concept document attached to the category object (linked under IUCLID section 0.2) showing an overview of the strategy for all substances within the polyol esters category. All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b31e001-316b-451c-9e80-82d056fbead4/documents/IUC5-c851a21c-3fff-4afd-9313-51003e688e88_2f5bf390-f606-4e7e-95a8-e421837f78ad.html,,,,,, "Fatty acids, C8-18 and C18-unsatd., Me esters",67762-37-2,"OECD 422, rat: NOAEL = 1000 mg/kg bw/d of the read across substance methyl laurate. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/23ead5e6-31bf-4196-a3c5-cc1d6f7a987c/documents/IUC5-3987de6a-2dc2-4fcc-b155-39bec9173416_2501c055-e125-4005-b618-c6899c8c1b24.html,,,,,, "Fatty acids, C8-18 and C18-unsatd., Me esters",67762-37-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/23ead5e6-31bf-4196-a3c5-cc1d6f7a987c/documents/IUC5-3987de6a-2dc2-4fcc-b155-39bec9173416_2501c055-e125-4005-b618-c6899c8c1b24.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,740 mg/kg bw/day,, "Fatty acids, C8-18 and C18-unsatd., Me esters",67762-37-2,"All available acute oral toxicity studies within this category resulted in acute oral LD50 in rats greater than 2000 mg/kg bw.Studies on acute oral toxicity were available for the following members of this category (CAS No.): 111-11-5, 111-82-0, 112-39-0, 112-61-8, 91051-34-2, 61788-59-8, 106-70-7, 112-63-0.The NOAEC for 111-82-0 was found to be > 5 mg/L air.No acute dermal toxicity studies were available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23ead5e6-31bf-4196-a3c5-cc1d6f7a987c/documents/IUC5-977b4f00-2305-4aac-98ca-25a36c5d394b_2501c055-e125-4005-b618-c6899c8c1b24.html,,,,,, "Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide",1000817-22-0,"NOAEL systemic toxicity: 1000 mg/kg bw (highest dose tested, OECD 407, BASF SE 2010)NOAEL local effects: 300 mg/kg bw (OECD 407, BASF SE, 2010) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/71c227e0-bc92-4958-b4dd-aeaaab8b06ee/documents/IUC5-387f0091-b3d9-4161-9c1f-5f3c84bc5b10_019658d0-9d61-4820-90b9-10062f394d40.html,,,,,, "Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide",1000817-22-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/71c227e0-bc92-4958-b4dd-aeaaab8b06ee/documents/IUC5-387f0091-b3d9-4161-9c1f-5f3c84bc5b10_019658d0-9d61-4820-90b9-10062f394d40.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C8-18 and C18-unsatd., reaction products with diethanolamine and propylene oxide",1000817-22-0,"LD50 (oral) > 2000 mg/kg (BASF SE, 2009)LD50 (dermal) > 2000 mg/kg (BASF SE, 2009)LC50 (inhalation) > 5.3 mg/L (BASF SE, 2016) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71c227e0-bc92-4958-b4dd-aeaaab8b06ee/documents/IUC5-91b558ae-4d8f-4c52-b638-75e55e888435_019658d0-9d61-4820-90b9-10062f394d40.html,,,,,, "Fatty acids, C8-18 and C18-unsatd., zinc salts",67762-34-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a8828064-1bcc-4666-a49c-8acf04879de4/documents/7ba13db4-fb6c-4c23-b0bd-92ed0245fbd7_f6191389-40f6-4af6-9c6f-ea7544d1aef1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Fatty acids, C8-18 and C18-unsatd., zinc salts",67762-34-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8828064-1bcc-4666-a49c-8acf04879de4/documents/bb48a02f-becc-491c-9fd9-cc3fe1438d73_f6191389-40f6-4af6-9c6f-ea7544d1aef1.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C8-18 and C18-unsatd., zinc salts",67762-34-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8828064-1bcc-4666-a49c-8acf04879de4/documents/bb48a02f-becc-491c-9fd9-cc3fe1438d73_f6191389-40f6-4af6-9c6f-ea7544d1aef1.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C8-24",71076-48-7,"Reliable studies on oral repeated dose toxicity are available for the following category members:Subchronic: NOAEL oral = ca. 5000 mg/kg bw/d; CAS# 143-07-7, C12 (Fitzhugh 1960)Subchronic: NOAEL oral = 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao 2002)No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f476be6-5433-4a13-8569-76b09772c332/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_ec8ba91a-be4c-4ce7-962c-2a51f5ee958d.html,,,,,, "Fatty acids, C8-24",71076-48-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f476be6-5433-4a13-8569-76b09772c332/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_ec8ba91a-be4c-4ce7-962c-2a51f5ee958d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, C8-24",71076-48-7,Acute Toxicity:- oral: LD50 (rat) >2000 mg/kg bw (OECD 401);- inhalative: LC50 >90.1521 mg/L (IHT; Analogy CAS 124-07-2);- dermal: LD50 >2000 mg/kg bw (Analogy CAS 57-11-4); ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f476be6-5433-4a13-8569-76b09772c332/documents/IUC5-2b763d61-90f4-46c3-83e3-4fe40f842f7a_ec8ba91a-be4c-4ce7-962c-2a51f5ee958d.html,,,,,, "Fatty acids, C9-13-neo-",68938-07-8,Repeated exposure may cause skin dryness or cracking. No systemic toxicity is observed. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/181e1ba8-3bd7-495f-a277-312616f47a4a/documents/1b6a09b2-bc58-47a1-a50d-02fb108559e0_90b9179f-53d1-4e8f-9a23-834b95e76f05.html,,,,,, "Fatty acids, C9-13-neo-",68938-07-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/181e1ba8-3bd7-495f-a277-312616f47a4a/documents/1b6a09b2-bc58-47a1-a50d-02fb108559e0_90b9179f-53d1-4e8f-9a23-834b95e76f05.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,, "Fatty acids, C9-13-neo-, barium salts",92044-82-1,"No repeated dose toxicity study with fatty acids, C9-13-neo-, barium salts is available, thus the repeated dose toxicity will be addressed with existing data on the individual assessment entities barium and fatty acids, C9-13-neo-, represented by neodecanoic acid. In relevant and reliable repeated dose toxicity studies as well as supporting studies for both moieties of fatty acids, C9-13-neo-, barium salts, there were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac5d66d1-a81a-4e8f-9997-6d49b9ddd6e9/documents/3a51418a-7ce0-4daf-b9c5-12088ea0747b_c9e78eee-0a6d-4615-8c3d-25afdce4d000.html,,,,,, "Fatty acids, C9-13-neo-, barium salts",92044-82-1,"The experimentally measured oral LD50 for fatty acids, C9-13-neo-, barium salts is >300 and ≤2000 mg/kg bw, hence the substance is to be classified as acute oral toxicity category 4 according to Regulation (EC) 1272/2008. No classification is required for specific target organ toxicity, single exposure (STOT SE). No acute dermal toxicity studies with fatty acids, C9-13-neo-, barium salts are available, thus the acute toxicity will be addressed with existing data on the dissociation products barium and fatty acids, C9-13-neo-. Signs of acute dermal toxicity are not expected for fatty acids, C9-13-neo-, barium salts, since the LD50 for both constituents (barium and fatty acids, C9-13-neo-, represented by its structural analogue neodecanoic acid) is above 2000 mg/kg bw. Based on the above given information fatty acids, C9-13-neo-, barium salts is not expected to show any acute toxic effects via dermal route and does not require a classification for acute dermal toxicity (cf. Annex VIII section 8.5 Column 2 of Regulation (EC) 1907/2006). Due to the legal classification of all barium salts (Index Nr. 056-002-00-7), fatty acids, C9-13-neo-, barium salts is also classified for acute inhalation toxicity category 4 (H332). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac5d66d1-a81a-4e8f-9997-6d49b9ddd6e9/documents/33ec33a9-fe7f-46fd-afef-d864df7994a7_c9e78eee-0a6d-4615-8c3d-25afdce4d000.html,,,,,, "Fatty acids, C9-13-neo-, barium salts",92044-82-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac5d66d1-a81a-4e8f-9997-6d49b9ddd6e9/documents/33ec33a9-fe7f-46fd-afef-d864df7994a7_c9e78eee-0a6d-4615-8c3d-25afdce4d000.html,,oral,LD50,ca.500 mg/kg bw,adverse effect observed, "Fatty acids, C9-13-neo-, calcium salts",68424-35-1,"Toxicity via the oral route is addressed by upper intake levels (UL) for adults determined by the Scientific Committee on Food (SCF), beingUL = 2500 mg/d, corresponding to 36 mg/kg bw/d (70 kg person) for calcium. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/b501c6b4-bc63-4e38-8da0-f7d396e9b057/documents/IUC5-891a5ed4-b190-4a2d-bab9-fc704a643395_63514b72-da3f-4410-b333-27b123c4ab71.html,,,,,, "Fatty acids, C9-13-neo-, copper salts",91031-79-7,"No repeated dose toxicity study with fatty acids, C9-13-neo-, copper salts is available, thus the repeated dose toxicity will be addressed with existing data on the individual assessment entities copper and fatty acids, C9-13-neo-, represented by neodecanoic acid. In relevant and reliable repeated dose toxicity studies as well as supporting studies for both moieties of fatty acids, C9-13-neo-, copper salts, there were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf7e676c-ccf5-44c4-8f89-3b825a939c3a/documents/752c16df-7f30-42d0-aa55-a93c94b9f8be_0e14da03-267d-42ce-8e11-522f281ccd0b.html,,,,,, "Fatty acids, C9-13-neo-, copper salts",91031-79-7,"The experimentally measured oral LD50 for fatty acids, C9-13-neo-, copper salts is >2000 mg/kg bw, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral toxicity as well as for specific target organ toxicity, single exposure (STOT SE). No acute dermal toxicity studies with fatty acids, C9-13-neo-, copper salts are available, thus the acute toxicity will be addressed with existing data on the dissociation products copper and fatty acids, C9-13-neo-. Signs of acute dermal toxicity are not expected for fatty acids, C9-13-neo-, copper salts, since the LD50 for both constituents (copper and fatty acids, C9-13-neo-, represented by its structural analogue neodecanoic acid) is above 2000 mg/kg bw. Based on the above given information fatty acids, C9-13-neo-, copper salts is not expected to show any acute toxic effects via dermal route and does not require a classification for acute dermal toxicity (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf7e676c-ccf5-44c4-8f89-3b825a939c3a/documents/de5e011a-32af-42f2-bb36-7463cccc87a9_0e14da03-267d-42ce-8e11-522f281ccd0b.html,,,,,, "Fatty acids, C9-13-neo-, copper salts",91031-79-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf7e676c-ccf5-44c4-8f89-3b825a939c3a/documents/de5e011a-32af-42f2-bb36-7463cccc87a9_0e14da03-267d-42ce-8e11-522f281ccd0b.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, C9-13-neo-, potassium salts",92044-83-2," No acute toxicity studies with fatty acids, C9 -13 neo, potassium salts are available, thus the acute toxicity will be addressed with existing data on the individual moieties potassium and neodecanoate. Signs of acute oral or acute dermal toxicity are not expected for fatty acids, C9 -13 neo, potassium salts, since the two moieties potassium and neodecanoic acid have not shown signs of acute oral or acute dermal toxicity in experimental testing (both LD50 > 2000mg/kg).   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb81a3f6-50d1-4c6c-9e60-d933800f7789/documents/ab0efe9d-2046-4127-a1d4-0a2fe712ff6f_f029c2cf-d0bb-42a4-ad28-5acf15e86b75.html,,,,,, "Fatty acids, C9-13-neo-, zinc salts",92044-84-3,"Fatty acids, C9-13-neo-, zinc salt is not expected to show acute toxic effects via oral and dermal route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3c6f87c-a743-4839-9f64-3d098bfcc319/documents/IUC5-e4171945-74e4-4551-8291-e9e678a65d27_42622692-5100-40f9-b85c-fbd7132e272b.html,,,,,, "Fatty acids, coco, esters with 1,3-butanediol",73138-39-3," Oral (Read-across, equivalent to OECD 408, rat) NOAEL: 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5beda300-f646-43e4-81d3-f1179708de78/documents/9e019360-50be-47a4-8da5-ec83befe220c_9d4d6836-a141-4167-9520-8f75fe0c6c12.html,,,,,, "Fatty acids, coco, esters with 1,3-butanediol",73138-39-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5beda300-f646-43e4-81d3-f1179708de78/documents/9e019360-50be-47a4-8da5-ec83befe220c_9d4d6836-a141-4167-9520-8f75fe0c6c12.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, coco, esters with 1,3-butanediol",73138-39-3, Oral (OECD 423): LD50 rat > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5beda300-f646-43e4-81d3-f1179708de78/documents/3a6a44ee-ace9-4846-9ffb-59df0b796e93_9d4d6836-a141-4167-9520-8f75fe0c6c12.html,,,,,, "Fatty acids, coco, esters with 3,3'-oxybis[1,2-propanediol]",85029-63-6, A NOAEL of 1000 mg/kg bw/day could be derived from a reliable combined repeated dose and reproduction screening study in rats. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c5ce1caf-e772-46a4-bd78-1b7fcf1933a7/documents/6dbe34fc-c79c-49bb-93e0-dd563606ae06_30285cf9-f57b-47a7-9a83-68be66931063.html,,,,,, "Fatty acids, coco, esters with 3,3'-oxybis[1,2-propanediol]",85029-63-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c5ce1caf-e772-46a4-bd78-1b7fcf1933a7/documents/6dbe34fc-c79c-49bb-93e0-dd563606ae06_30285cf9-f57b-47a7-9a83-68be66931063.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, coco, esters with 3,3'-oxybis[1,2-propanediol]",85029-63-6," The oral LD50 in rats was > 2000 mg/kg bw in a reliable study. There is no study on acute inhalation and dermal toxicity available. The acute inhalation study was waived in accordance with Annex XI No 1.2: no testing for acute toxicity after inhalations exposure has to be performed because there is sufficient evidence from existing studies that the substance is not acutely toxic up to the limit doses (e.g. acute oral toxicity study with LD50 > 2000 mg/kg; OECD 422 study: NOAEL 1000 mg/kg bw). The acute dermal study was waived in accordance with Annex XI No 1.2: it is scientifically not necessary to perform an acute dermal toxicity study, because existing data indicate that it can be plausibly assumed that a dermal LD50 of > 2000 mg/kg would result based - on the findings of an acute oral toxicity study in rats with a LD50 > 2000 mg/kg, - on the findings of an OECD 422 study with oral application which did not reveal adverse effects up to the limit dose of 1000 mg/kg/d, - on the plausible assumption that dermal absorption would not exceed oral absorption. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5ce1caf-e772-46a4-bd78-1b7fcf1933a7/documents/cb762697-4423-4260-9349-b60bb6509e62_30285cf9-f57b-47a7-9a83-68be66931063.html,,,,,, "Fatty acids, coco, esters with oxybis(propanediol)",85711-49-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (OECD 422) was carried out with an administration period for Males, 42 days and Females approximately 54 days (from 14 days before mating to day 4 of lactation (Satellite group for the recovery of females, 42 days)) which is between subabcute and subchronic. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb9570d0-e598-48fd-baf2-e281d23b8a2b/documents/142c3064-3e4b-475a-9cc7-b42eb2277866_d81bb3ee-49ba-4170-999d-04398919106b.html,,,,,, "Fatty acids, coco, esters with oxybis(propanediol)",85711-49-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb9570d0-e598-48fd-baf2-e281d23b8a2b/documents/142c3064-3e4b-475a-9cc7-b42eb2277866_d81bb3ee-49ba-4170-999d-04398919106b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, coco, esters with oxybis(propanediol)",85711-49-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb9570d0-e598-48fd-baf2-e281d23b8a2b/documents/2bef4b2a-dae5-4f90-a871-91a13221b2e3_d81bb3ee-49ba-4170-999d-04398919106b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, coco, esters with oxybis(propanediol)",85711-49-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb9570d0-e598-48fd-baf2-e281d23b8a2b/documents/2bef4b2a-dae5-4f90-a871-91a13221b2e3_d81bb3ee-49ba-4170-999d-04398919106b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, coco, iso-Bu esters",91697-43-7," In summary, subacute and subchronic studies on Source substance Fatty acids, C16-18, isobutyl esters consistently showed no adverse systemic effects resulting in NOAELs of 1000 mg/kg bw/day and higher. The same is assumed for the target substance. There are no data available on the repeated dose toxicity after inhalation of the target substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1741685d-fa38-4557-888d-203b14426efe/documents/bd5d881e-d4ef-477d-9322-63e8813725c6_1bd736d3-7420-44de-ae36-15f098f40779.html,,,,,, "Fatty acids, coco, iso-Bu esters",91697-43-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1741685d-fa38-4557-888d-203b14426efe/documents/bd5d881e-d4ef-477d-9322-63e8813725c6_1bd736d3-7420-44de-ae36-15f098f40779.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, coco, iso-Bu esters",91697-43-7," No adverse effects are predicted for the target substance FATTY ACIDS, COCO, ISO-BU ESTERS (CAS 91697-43-7) . ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1741685d-fa38-4557-888d-203b14426efe/documents/40a26a54-a5fd-4c8f-97a2-534eac450c8f_1bd736d3-7420-44de-ae36-15f098f40779.html,,,,,, "Fatty acids, coco, iso-Bu esters",91697-43-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1741685d-fa38-4557-888d-203b14426efe/documents/40a26a54-a5fd-4c8f-97a2-534eac450c8f_1bd736d3-7420-44de-ae36-15f098f40779.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, coco, iso-Bu esters",91697-43-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1741685d-fa38-4557-888d-203b14426efe/documents/40a26a54-a5fd-4c8f-97a2-534eac450c8f_1bd736d3-7420-44de-ae36-15f098f40779.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, coco, iso-Bu esters",91697-43-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1741685d-fa38-4557-888d-203b14426efe/documents/40a26a54-a5fd-4c8f-97a2-534eac450c8f_1bd736d3-7420-44de-ae36-15f098f40779.html,,inhalation,LC50,"5,300 mg/m3",no adverse effect observed, "Fatty acids, coco, isotridecyl esters",91031-91-3,NOAEL systemic= 300 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a4e49b9-f744-4ce5-afef-fdf02fb5ca3e/documents/IUC5-5ebc1a53-527b-484d-b6cf-fd1242616a5d_e94ed25f-d228-48e5-b9e3-2426819494f5.html,,,,,, "Fatty acids, coco, isotridecyl esters",91031-91-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a4e49b9-f744-4ce5-afef-fdf02fb5ca3e/documents/IUC5-5ebc1a53-527b-484d-b6cf-fd1242616a5d_e94ed25f-d228-48e5-b9e3-2426819494f5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Fatty acids, coco, isotridecyl esters",91031-91-3,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a4e49b9-f744-4ce5-afef-fdf02fb5ca3e/documents/IUC5-b978fe4c-1f67-4f16-bed5-0f50fbcbb1bd_e94ed25f-d228-48e5-b9e3-2426819494f5.html,,,,,, "Fatty acids, dehydrated castor-oil",61789-45-5,"Key studies on oral repeated dose toxicity are available for the following category members:Subchronic (84 days, rat): NOAEL oral ≥ 12500 mg/kg bw/day; CAS# 112-80-1, C18:1 (Calandra, 1969)Subacute (OECD 422, rat): NOAEL oral ≥ 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao et al., 2002)Subacute (OECD 407, rat): NOAEL oral ≥ 1000 mg/kg bw/day; CAS# 112-05-0, C9 (van Otterdijk, 2002)Subacute (OECD 407, rat): NOAEL oral ≥ 1000 mg/kg bw/day; CAS# 70321-72-1, C8-18 and C18-unsatd, distn. residues (Potokar, 1983)In conclusion, no human hazard for systemic toxicity after repeated oral exposure was identified for the members of the fatty acids category.No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25a7e66e-3196-4311-8432-e4f79ad672a5/documents/IUC5-8dec131f-cec7-4faf-b28f-751d35c4501c_877a2908-32ea-43e7-8f9e-7f25f41856a8.html,,,,,, "Fatty acids, dehydrated castor-oil",61789-45-5,"Oral (OECD 401), rat: LD50 > 5000 mg/kg bw; CAS# 57-10-3, C16 (Gloxhuber and Kästner, 1981)Oral (OECD 401), rat: LD50 > 5000 mg/kg bw; CAS# 57-11-4, C18 (Gloxhuber and Kästner, 1981)Oral (OECD 401), rat: LD50 > 2000 mg/kg bw; CAS# 57-11-4, C18 (Daamen, 1989)Oral (OECD 401), rat: LD50 > 2000 mg/kg bw; CAS# 112-80-1, C18:1 (Reijnders and Daamen, 1988)Oral (OECD 401), rat: LD50 > 5000 mg/kg bw; CAS# 112-80-1, C18:1 (Gloxhuber and Kästner, 1981)Oral (EU method B.1), rat: LD50 > 5000 mg/kg bw; CAS# 112-80-1, C18:1 (Potokar, 1984)Inhalation, IRT, rat, 8h: LC50 >1.3682 mg/L air; CAS# 142-62-1, C6 (Smyth et al., 1954)Dermal (OECD 402, limit test), rat: LD50 >2000 mg/kg bw ; CAS# 112-05-0, C9 (van Otterdijk, 2001)Dermal (OECD 402, limit test), rat: LD50 >2000 mg/kg bw; CAS# 111-20-6, C10d (Yu, 1999)Dermal (OECD 402, limit test), rat: LD50 >2000 mg/kg bw; CAS# 334-48-5, C10 (TalviOja, 2006) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25a7e66e-3196-4311-8432-e4f79ad672a5/documents/IUC5-39ecd6a3-bceb-4a73-b5e1-5bc32e436f6b_877a2908-32ea-43e7-8f9e-7f25f41856a8.html,,,,,, "Fatty acids, essential, Et esters",91051-05-7,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eeddf790-ded1-4644-94c6-6b1412bb13c4/documents/IUC5-2be39757-41f7-4a49-b03d-300254e7bacb_f4a5d794-b245-4a55-951c-ae398222db28.html,,,,,, "Fatty acids, essential, Et esters",91051-05-7,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eeddf790-ded1-4644-94c6-6b1412bb13c4/documents/IUC5-b7765b29-fc70-4101-8017-28197aa32203_f4a5d794-b245-4a55-951c-ae398222db28.html,,,,,, "Fatty acids, hydrogenated tallow, distn. residues",70084-85-4,"Reliable studies on oral repeated dose toxicity are available for the following category members:Subchronic: NOAEL oral = ca. 5000 mg/kg bw/d; CAS# 143-07-7, C12 (Fitzhugh 1960)Subchronic: NOAEL oral = 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao 2002)No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a2e4c6c-81de-46d0-9540-ae7613b1aa64/documents/IUC5-3255f514-a0cb-4eff-a186-18f2bc83a13f_e008651c-db33-4e52-a7db-fb48192c502c.html,,,,,, "Fatty acids, hydrogenated tallow, distn. residues",70084-85-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a2e4c6c-81de-46d0-9540-ae7613b1aa64/documents/IUC5-3255f514-a0cb-4eff-a186-18f2bc83a13f_e008651c-db33-4e52-a7db-fb48192c502c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, hydrogenated tallow, distn. residues",70084-85-4,"Acute toxicity:- oral: LD50 >5000 mg/kg bw (OECD 401; Analogy CAS CAS 57-10-3, CAS 57-11-4);- inhalative: LC50 >0.1521 mg/L (IHT; Analogy CAS 124-07-2);- dermal: LD50 > 2000 mg/kg bw (Analogy CAS 57-11-4); ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a2e4c6c-81de-46d0-9540-ae7613b1aa64/documents/IUC5-3335c0ae-324a-4768-b6ef-182028618624_e008651c-db33-4e52-a7db-fb48192c502c.html,,,,,, "Fatty acids, lanolin, esters with cholesterol-low lanolin alcs.",92044-94-5," According to OECD 408 and under GLP conditions, Lanolin alcohols was administered by gavage to three groups, each of ten male and ten female rats, for 90 consecutive days, at dose levels of 100, 300 and 1000 mg/kg bw/day (Duster 2014). A control group of ten males and ten females was dosed with vehicle alone (Arachis oil BP). Observations and examinations of the animals included clinical signs, neurobehaviour, body weight, food consumption, hematology, blood chemistry, ophthalmoscopy, gross necropsy and histopathology. There were no unscheduled deaths. Animals treated with 1000 mg/kg bw/day showed episodes of increased salivation (males/females) and episodes of red/brown staining around the snout (males). However, these observations are commonly observed following the oral administration of an unpalatable test item formulation and in isolation are not indicative of systemic toxicity. Males treated with 1000 mg/kg bw/day and 100 mg/kg bw/day showed a statistically significant effects in functional performance (reduced mean forelimb grip strength, increased mean hindlimb grip strength. As the intergroup differences were confined to one out of the three tests and in the absence of any associated clinical signs to suggest a neurotoxic effect, the intergroup differences were considered not to be of toxicological importance. Males treated with 300 mg/kg bw/day showed a statistically significant increase in overall activity. In the absence of a true dose related response the intergroup difference was considered not to be of toxicological significance. Thus, there were no treatment-related changes in behavioral parameters measured, sensory reactivity and no toxicologically relevant changes in functional performance. No adverse effects were detected in body weight gain in treated animals when compared to controls. Males from all treatment groups showed a statistically significant reduction in body weight gain during Week 8. Males treated with 100 mg/kg bw/day also showed a statistically significant reduction in body weight gain during Week 4. The intergroup differences did not show a true dose related response and overall body weight gain for these males was comparable to control males. Therefore this slight reduction was considered not to be of toxicological significance. No adverse effects in overall food consumption, water consumption or food efficiency were detected in treated animals when compared to controls. There were no treatment-related ocular effects detected. There were no toxicologically significant effects detected in the hematological and in the blood chemical parameters examined. Males treated with 1000 mg/kg bw/day showed a statistically significant reduction in mean corpuscular hemoglobin concentration and a statistically significant increase in prothrombin time. Males from all treatment groups showed a statistically significant reduction in eosinophils. Males treated with 100 mg/kg bw/day also showed a statistically significant increase in erythrocyte count. The majority of individual values were within normal background ranges for these parameters and in the absence of a true dose related response the intergroup differences were considered not to be of toxicological importance. Males treated with 1000 mg/kg bw/day showed statistically significant reductions in phosphorus and bilirubin. The majority of individual values were within normal background ranges for these parameters and in the absence of any associated histopathological changes the intergroup differences were considered not to be of toxicological importance. Females treated with 1000 mg/kg bw/day showed a statistically significant increase in glucose. Although the majority of individual values were outside of the normal range for this parameter, in the absence of any associated histopathological changes the intergroup difference was considered not to represent an adverse effect of treatment. At necropsy, no toxicologically significant macroscopic abnormalities were detected. Two males treated with 1000 mg/kg bw/day and two females treated with 300 mg/kg bw/day had reddened lungs at necropsy. Microscopic examination revealed agonal congestion and hemorrhage in these animals which accounts for the macroscopic observations detected. These changes were not considered to represent a true treatment related effect. There were no treatment-related effects detected in the organ weights examined. An increase in incidence of minimal or mild alveolar macrophages were evident in females treated with 1000 and 300 mg/kg bw/day. No such effects were detected in males treated with 1000 or 300 mg/kg bw/day or animals of either sex treated with 100 mg/kg bw/day. The affected macrophages had abundant foamy cytoplasm and may have arisen from the accidental inhalation of small amounts of the test item during dosing or possibly phospholipidosis. However, apart from occasional perivascular infiltration of mononuclear inflammatory cells adjacent to the foci there was no evidence of associated inflammation or damage to surrounding alveoli. It is, therefore, considered likely that the change was adaptive rather than an adverse effect of treatment. In conclusion, the oral administration of Lanolin Alcohols to rats by gavage did not result in any toxicologically significant adverse effects. The NOAEL was therefore considered to be >= 1000 mg/kg bw/day for systemic toxicity. A 90-day repeated dose toxicity study was performed in rats according to OECD 408, using Lanolin Fatty Acids (CAS 68424-43-1) (Braun, 2013). Ten Han-Wistar rats per sex and dose were administered 100, 300 and 1000 mg/kg bw/day of the test substance in corn oil by gavage, for 91 (females) or 92 (males) consecutive days. Control animals (10 per sex and dose) received the concurrent vehicle, corn oil. Observations and examinations of the animals included clinical signs, body weight, food consumption, haematology, clinical chemistry, urinalysis, organ weights, neurobehaviour, gross necropsy and histopathology. The daily oral administration of the test substance was tolerated without any adverse effects up to the high dose of 1000 mg/kg bw/day. One male of the 300 mg/kg bw/day dose group was killed in extremis subsequent to a dosing error. No further mortality was observed. There were no toxicologically significant effects on body weight, food consumption and clinical condition up to and including the highest dose level. There were no test item-related ophthalmoscopic changes at any dose level. There were no test item-related differences in the mean haematology, clinical chemistry and urine parameters at any dose level. Incidental changes of haematology parameters as reduced methaemoglobin levels (1000 mg/kg bw/day; males), reduced mean medium-fluorescene reticulocytes (1000 mg/kg bw/day; males), elevated mean relative eosinophils (300 mg/kg bw/day; females), and elevated mean and absolute eosinophils and reduced platelet count (100 mg/kg bw/day; females) were observed, which were statistically significant but remained within the range of the historical control values. The relative thrombin time was elevated in females of all dose groups and was outside the range of the historical controls. As the control values were also outside the historical control data, the effect was not considered to be treatment-related. There were no test item-related clinical observations evident during the functional observational battery (week 13) at any dose level. The mean hind limb grip strength values of female rats treated with 1000 mg/kg bw/day was statistically reduced (p<0.05) when compared with the mean values of the control rats. The mean fore- and hind limb grip strength values of the remaining test item-treated rats compared favorably with those of the respective control rats. There were no test item-related differences in the mean locomotor activity at any dose level. There were no test item-related changes in the mean absolute or relative organ weights at any dose level. In females treated with 300 mg/kg bw/day, significantly elevated mean absolute liver and thymus weights (p<0.05) were noted. The mean liver and thymus brain weight ratios were significantly elevated (p<0.05 or p<0.01) when compared with the controls. The organ to body weight ratio of these organs was not statistically significant. The microscopic findings recorded in this study were considered to be within the normal range of background alterations that is seen in untreated animals of this age and strain. In particular, a small increase in incidence of brown pigment in hepatocytes and macrophages in the liver of high dose group males and females was considered unrelated to treatment as this is a common incidental finding in control rats of this strain and age. The examination of the ovaries and the female genital tract did not reveal any difference in oestrus cycling between control and treated animals. The male genital organs were also normal. In conclusion, as no adverse effects were observed up to the highest dose of 1000 mg/kg bw/day, a NOAEL of ≥1000 mg/kg bw/day was derived. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9aeee81-197b-448a-be85-de2519992bb5/documents/e4943461-711f-47da-99b6-d666331ccb3e_f147c4c3-9067-4828-8e56-1eb69689d753.html,,,,,, "Fatty acids, lanolin, esters with cholesterol-low lanolin alcs.",92044-94-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9aeee81-197b-448a-be85-de2519992bb5/documents/e4943461-711f-47da-99b6-d666331ccb3e_f147c4c3-9067-4828-8e56-1eb69689d753.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, lanolin, esters with cholesterol-low lanolin alcs.",92044-94-5," Albino rats in groups of ten (5M:5F), weighing between 150 and 300 g, were dosed with 5000 mg/kg lanolin fatty acids once using an oral method, and observed for fourteen days (Lewis 1977). The LD50 of the test material has been determined to be greater than 5 g/kg/bw. A study to determine the oral toxicity of Lanolin alcohols was conducted following the OECD Guideline 401 and EC guideline B1 (Leuschner 2001). Under the test conditions (a single oral dose of the test material at 2000 mg/kg bw) to rats revealed no toxic symptoms. The LD50 is > 2000 mg/kg bw. A group of ten animals (five males and five females) was given a single, 24‑hour, semi‑occluded dermal application of lanolin fatty esters to intact skin at a dose level of 2000 mg/kg bodyweight (Bradshaw 2010). Bodyweight gain was slightly low in females during the first week of observations. Very slight erythema was observed at the applications sites. The acute dermal LD50of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bw. A group of ten animals (five males and five females) was given a single, 24‑hour, semi‑occluded dermal application of lanolin alcohols to intact skin at a dose level of 2000 mg/kg bodyweight (Bradshaw 2010). No effects on bodyweight gain, clinical observations and macroscopy were observed. The acute dermal LD50of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9aeee81-197b-448a-be85-de2519992bb5/documents/c5cbad1f-13cf-400b-a1c1-f5698adf23ae_f147c4c3-9067-4828-8e56-1eb69689d753.html,,,,,, "Fatty acids, lanolin, esters with cholesterol-low lanolin alcs.",92044-94-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9aeee81-197b-448a-be85-de2519992bb5/documents/c5cbad1f-13cf-400b-a1c1-f5698adf23ae_f147c4c3-9067-4828-8e56-1eb69689d753.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, lanolin, esters with cholesterol-low lanolin alcs.",92044-94-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9aeee81-197b-448a-be85-de2519992bb5/documents/c5cbad1f-13cf-400b-a1c1-f5698adf23ae_f147c4c3-9067-4828-8e56-1eb69689d753.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, lanolin, esters with pentaerythritol",68440-09-5,All available subacute and subchronic repeated dose oral toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater.The available subchronic repeated dose inhalation toxicity study results in NOAEC 0.5mg/L.The available subchronic repeated dose dermal toxicity study results in NOAEL of 2000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b593a94-7ea2-4a23-b8b0-9af0c8e20d5c/documents/IUC5-237773a5-eee1-43ad-b26f-a56a1ab160b9_80011857-c8ff-4300-82f9-06b750471788.html,,,,,, "Fatty acids, lanolin, esters with pentaerythritol",68440-09-5,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b593a94-7ea2-4a23-b8b0-9af0c8e20d5c/documents/IUC5-6061f3bf-d998-4bf9-8b31-fb35e9d80cbf_80011857-c8ff-4300-82f9-06b750471788.html,,,,,, "Fatty acids, lanolin, lithium salts",68154-72-3," No data on acute toxicity by oral route is available for the substance fatty acids lanolin lithium salts. Read across from dilithium sebacate and fatty acids lanolin is used to complete this endpoint. The LD50 value for fatty acids lanolin was >5 g/kg bw. For dilithium sebacate, the oral LD50 value is within the range 300 mg/kg bw - 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17bfea55-0369-42b1-97b0-aa232130b85e/documents/9121268c-2913-4ed0-9e02-3451c962e3bb_819f5610-f273-46af-8366-d81e71639b12.html,,,,,, "Fatty acids, lanolin, lithium salts",68154-72-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17bfea55-0369-42b1-97b0-aa232130b85e/documents/9121268c-2913-4ed0-9e02-3451c962e3bb_819f5610-f273-46af-8366-d81e71639b12.html,,oral,LD50,"4,483 mg/kg bw",no adverse effect observed, "Fatty acids, lanolin, lithium salts",68154-72-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17bfea55-0369-42b1-97b0-aa232130b85e/documents/9121268c-2913-4ed0-9e02-3451c962e3bb_819f5610-f273-46af-8366-d81e71639b12.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, linseed-oil, reaction products with 2-amino-2-(hydroxymethyl)-1,3-propanediol and formaldehyde",80584-99-2," VOELOFA Monomer was tested in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422). Dose groups were based on the results of a 14-day dose range finding study. Based on the results, the LOAEL for repeated dose toxicity is considered to be 300 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/883df416-0983-4a94-aa03-555f94a723ff/documents/bb6a7255-dcb6-4839-a854-bd8109f396ad_301fb4ce-6fc0-46b8-a6e9-4327cc9036d3.html,,,,,, "Fatty acids, linseed-oil, reaction products with 2-amino-2-(hydroxymethyl)-1,3-propanediol and formaldehyde",80584-99-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/883df416-0983-4a94-aa03-555f94a723ff/documents/bb6a7255-dcb6-4839-a854-bd8109f396ad_301fb4ce-6fc0-46b8-a6e9-4327cc9036d3.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,300 mg/kg bw/day,,rat "Fatty acids, linseed-oil, reaction products with 2-amino-2-(hydroxymethyl)-1,3-propanediol and formaldehyde",80584-99-2," In an acute dermal toxicity study according to OECD 402, groups of young adult Wister rats (5 male/ 5 female) were dermally exposed to VOELOFA Monomer (100% purity) for 4 hours at a limit dose of 2000 mg/kg bw and were observed for 14 days. Based on the results, the target substance does not require classification for acute toxicity according to CLP criteria. In an acute oral toxicity study according to OECD 423, two groups of fasted, 8-12 weeks old female Wistar rats (3 rats/ group) were given a single oral dose of  VOELOFA Monomer (100% purity) at the limit dose of 2000 mg/kg bw and were observed for 14 days. Based on the results, the target substance does not require classification for acute toxicity according to CLP criteria. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/883df416-0983-4a94-aa03-555f94a723ff/documents/65c0bd30-3a79-45cc-9dad-0f53865ec0af_301fb4ce-6fc0-46b8-a6e9-4327cc9036d3.html,,,,,, "Fatty acids, montan-wax, stearyl esters",68308-30-5," Oral: NOAEL m/f rat ≥ 1000 mg/kg bw/day Read-across from structural analogue source substance docosyl docosanoate (CAS 17671-27-1, key) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a424eb3-6065-408e-a33e-1b2c5f295186/documents/517932df-864b-421b-bc8e-811a3c68b48a_0229b98c-f0f8-4e65-9bf4-f529ee92bef9.html,,,,,, "Fatty acids, montan-wax, stearyl esters",68308-30-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a424eb3-6065-408e-a33e-1b2c5f295186/documents/517932df-864b-421b-bc8e-811a3c68b48a_0229b98c-f0f8-4e65-9bf4-f529ee92bef9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, montan-wax, stearyl esters",68308-30-5," Oral: LD50 (rat, female) > 2000 mg/kg bw   Inhalation: LC50 (rat, male/female) > 5.7 mg/L air Read-across from analogue source substance 2-ethylhexyl octadec-9-enoate (CAS 26399-02-0)   Dermal: LD50 m/f rat > 2000 mg/kg bw Read-across from analogue source substance 2-octyldodecyl isooctadecanoate (CAS 93803-87-3) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a424eb3-6065-408e-a33e-1b2c5f295186/documents/60da80f7-6df6-4bce-b280-f636ecadd954_0229b98c-f0f8-4e65-9bf4-f529ee92bef9.html,,,,,, "Fatty acids, rape-oil, hydrogenated, reaction products with diethylenetriamine, di-Me sulfate-quaternized",97281-29-3," Based on the results of the read across study, NOAEL for repeated dose oral toxicity of the test substance, 'di-C18-22 AAEMIM-MS' is considered as 300 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39106549-1ade-44eb-8aa7-a198b4c9b2ce/documents/77f24757-8ee5-4125-be53-e952148b5534_0f3f1f9e-b3d1-450b-a9b3-1326153af4c8.html,,,,,, "Fatty acids, rape-oil, hydrogenated, reaction products with diethylenetriamine, di-Me sulfate-quaternized",97281-29-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39106549-1ade-44eb-8aa7-a198b4c9b2ce/documents/77f24757-8ee5-4125-be53-e952148b5534_0f3f1f9e-b3d1-450b-a9b3-1326153af4c8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Fatty acids, rape-oil, hydrogenated, reaction products with diethylenetriamine, di-Me sulfate-quaternized",97281-29-3," Based on the results of the read across study as well as a study with the test substance, 'di-C18-22 AAEMIM-MS' is considered to be of low acute toxicity through acute oral and dermal routes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39106549-1ade-44eb-8aa7-a198b4c9b2ce/documents/7b6b7b09-e87d-4602-a3c3-268c82fa51ad_0f3f1f9e-b3d1-450b-a9b3-1326153af4c8.html,,,,,, "Fatty acids, rape-oil, hydrogenated, reaction products with diethylenetriamine, di-Me sulfate-quaternized",97281-29-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39106549-1ade-44eb-8aa7-a198b4c9b2ce/documents/7b6b7b09-e87d-4602-a3c3-268c82fa51ad_0f3f1f9e-b3d1-450b-a9b3-1326153af4c8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, rape-oil, hydrogenated, reaction products with diethylenetriamine, di-Me sulfate-quaternized",97281-29-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39106549-1ade-44eb-8aa7-a198b4c9b2ce/documents/7b6b7b09-e87d-4602-a3c3-268c82fa51ad_0f3f1f9e-b3d1-450b-a9b3-1326153af4c8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitol",93334-10-2,"Repeated dose toxicity, oral: toxicity studies from read-across analogues revealed no adverse effects up to the highest dose tested ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f1ff661-3b27-46e9-8254-dcb8b07f09ef/documents/36369bc8-01df-4a73-ad7e-a8dbd339991e_43d9a63f-c4d3-4a4c-ae35-8336fc0eab0e.html,,,,,, "Fatty acids, rape-oil, mixed esters with 1,4:3,6-dianhydro-d-glucitol, sorbitan and sorbitol",93334-10-2,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bwAcute toxicity: Inhalation LC50 (rat, m/f): > 5.27 mg/L air ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f1ff661-3b27-46e9-8254-dcb8b07f09ef/documents/eec98ffb-5683-4b40-a2f4-474ffc2dadc9_43d9a63f-c4d3-4a4c-ae35-8336fc0eab0e.html,,,,,, "Fatty acids, safflower-oil, Et esters",91051-53-5,"- LD50(oral) > 2000 mg/kg bw. (BASF, 2010)- LD50(dermal) > 2000 mg/kg bw. (BASF, 2010) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a8cbf0a-dbf0-4d20-a82f-2b6d5fb8c4e9/documents/53cf7356-6697-4b82-af10-bfbc65b238d5_d1af5225-7887-4bff-a93f-ab2c375fa70c.html,,,,,, "Fatty acids, soya, 2-ethylhexyl esters",93572-14-6,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8217f49d-0949-492d-b578-14fa3d5d6a54/documents/IUC5-b756d3b4-3513-442c-8add-c7cf776a9aae_6a7691a0-f1bf-4d1a-8b41-8f02210412e3.html,,,,,, "Fatty acids, soya, 2-ethylhexyl esters",93572-14-6,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401, analogue approach)Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, analogue approach)Acute toxicity: Inhalation LC50 (rat, m/f): > 5.3 mg/L air (OECD 436, analogue approach) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8217f49d-0949-492d-b578-14fa3d5d6a54/documents/IUC5-d1eb9e89-2e6d-40d2-bf31-02e31709fb7d_6a7691a0-f1bf-4d1a-8b41-8f02210412e3.html,,,,,, "Fatty acids, sunflower-oil, conjugated",68953-27-5,"Reliable studies on oral repeated dose toxicity are available for the following category members:Subchronic: NOAEL oral = ca. 5000 mg/kg bw/d; CAS# 143-07-7, C12 (Fitzhugh 1960)Subchronic: NOAEL oral = 1000 mg/kg bw/d; CAS# 112-85-6, C22 (Nagao 2002)No data are available for repeated dose toxicity after dermal exposure and inhalation, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0927e2c4-14e6-4197-84e2-099a26a7b098/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_b8b6d95a-9f33-4be0-9bf8-291083ba3b17.html,,,,,, "Fatty acids, sunflower-oil, conjugated",68953-27-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0927e2c4-14e6-4197-84e2-099a26a7b098/documents/IUC5-c4b6d278-25a9-44a1-9183-c547893f0acb_b8b6d95a-9f33-4be0-9bf8-291083ba3b17.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, sunflower-oil, conjugated",68953-27-5,Acute Toxicity:- oral: LD50 >2000 mg/kg bw (OECD 401; Analogy CAS 112-80-1);- inhalative: LC50 >0.1521 mg/L (IHT; Analogy CAS 124-07-2);- dermal: LD50 >2000 mg/kg bw (Analogy CAS 57-11-4); ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0927e2c4-14e6-4197-84e2-099a26a7b098/documents/IUC5-be3dfd3e-6aee-4c93-9795-1c9c2be8de65_b8b6d95a-9f33-4be0-9bf8-291083ba3b17.html,,,,,, "Fatty acids, sunflower-oil, conjugated, maleated,reation products with diethanolamine, maleated tall-oil fatty acids and triethanolamine",1415316-96-9," Effects dominated by content of DEA: Target organs are the haemeopoietic system (mild anemia) and the kidneys. Calculated NOAELs / LOAELs based on DEA content of 5.5%: oral: LOAEL = 255mg/kg (90 -day study), NOAEL = 236 (EOGRTS) Inhalation NOAEC = 0.27mg/L dermal LOAEL = 582mg/kg ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/52def0f3-2ddc-416d-ab13-7e4c8659c9de/documents/4f22fd8d-fe7d-44a6-9183-d45ab994c3dd_e073c2bc-4833-42b5-9c0e-bed6f3976895.html,,,,,, "Fatty acids, sunflower-oil, conjugated, maleated,reation products with diethanolamine, maleated tall-oil fatty acids and triethanolamine",1415316-96-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/52def0f3-2ddc-416d-ab13-7e4c8659c9de/documents/4f22fd8d-fe7d-44a6-9183-d45ab994c3dd_e073c2bc-4833-42b5-9c0e-bed6f3976895.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,236 mg/kg bw/day,,rat "Fatty acids, sunflower-oil, conjugated, maleated,reation products with diethanolamine, maleated tall-oil fatty acids and triethanolamine",1415316-96-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/52def0f3-2ddc-416d-ab13-7e4c8659c9de/documents/4f22fd8d-fe7d-44a6-9183-d45ab994c3dd_e073c2bc-4833-42b5-9c0e-bed6f3976895.html,Sub-chronic toxicity – systemic effects,dermal,LOAEL,582 mg/kg bw/day,,rat "Fatty acids, sunflower-oil, conjugated, maleated,reation products with diethanolamine, maleated tall-oil fatty acids and triethanolamine",1415316-96-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/52def0f3-2ddc-416d-ab13-7e4c8659c9de/documents/4f22fd8d-fe7d-44a6-9183-d45ab994c3dd_e073c2bc-4833-42b5-9c0e-bed6f3976895.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,272 mg/m3,,rat "Fatty acids, sunflower-oil, conjugated, maleated,reation products with diethanolamine, maleated tall-oil fatty acids and triethanolamine",1415316-96-9," LD50, rat, oral: > 2000mg/kg (BASF 2017) LD50, rat, dermal: > 2000mg/kg (BASF 2017) No mortality, very limited clinical signs ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52def0f3-2ddc-416d-ab13-7e4c8659c9de/documents/75a299e8-8f19-4a57-8f90-6439b15f5ec4_e073c2bc-4833-42b5-9c0e-bed6f3976895.html,,,,,, "Fatty acids, sunflower-oil, conjugated, maleated,reation products with diethanolamine, maleated tall-oil fatty acids and triethanolamine",1415316-96-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52def0f3-2ddc-416d-ab13-7e4c8659c9de/documents/75a299e8-8f19-4a57-8f90-6439b15f5ec4_e073c2bc-4833-42b5-9c0e-bed6f3976895.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, sunflower-oil, conjugated, maleated,reation products with diethanolamine, maleated tall-oil fatty acids and triethanolamine",1415316-96-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52def0f3-2ddc-416d-ab13-7e4c8659c9de/documents/75a299e8-8f19-4a57-8f90-6439b15f5ec4_e073c2bc-4833-42b5-9c0e-bed6f3976895.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, 1-methyl-1,2-ethanediyl esters",68390-58-9,"Two reliable repeated dose studies are available conducted in accordance with OECD TG 422 and 408. In both studies, the NOAEL was set as the highest dose level (1000 mg/kg/day) with minimal effects observed.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b9db8ab-b676-4654-904f-d675d1ca6071/documents/IUC5-e63d0b48-c1d3-4cb9-be97-4c7e3339e8cf_4dd0b2af-90ae-491b-a37c-915b9ea6c8d4.html,,,,,, "Fatty acids, tall-oil, 1-methyl-1,2-ethanediyl esters",68390-58-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b9db8ab-b676-4654-904f-d675d1ca6071/documents/IUC5-e63d0b48-c1d3-4cb9-be97-4c7e3339e8cf_4dd0b2af-90ae-491b-a37c-915b9ea6c8d4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, tall-oil, 1-methyl-1,2-ethanediyl esters",68390-58-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b9db8ab-b676-4654-904f-d675d1ca6071/documents/IUC5-e63d0b48-c1d3-4cb9-be97-4c7e3339e8cf_4dd0b2af-90ae-491b-a37c-915b9ea6c8d4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, tall-oil, Bu esters",67762-63-4,"Based on a weight of evidence approach, all available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 1000 mg/kg bw/day or greater. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/839236d8-82b0-420c-82cc-5522bed9ac16/documents/IUC5-2be39757-41f7-4a49-b03d-300254e7bacb_c494322d-45a6-4b46-bb84-fce4f219607d.html,,,,,, "Fatty acids, tall-oil, Bu esters",67762-63-4,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.3 mg/L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/839236d8-82b0-420c-82cc-5522bed9ac16/documents/IUC5-b7765b29-fc70-4101-8017-28197aa32203_c494322d-45a6-4b46-bb84-fce4f219607d.html,,,,,, "Fatty acids, tall-oil, C12-15-alkyl esters, sulfated, sodium salts",68424-50-0,The substance is of no concern for repeated dose / subacute toxicity ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3bb97b19-2380-48ba-87bb-08aeade68f5a/documents/IUC5-fc7c2f8d-4726-4990-9f26-c6264ccf7b07_46761a5c-80c0-4c34-b188-b8cdf9ac4c6b.html,,,,,, "Fatty acids, tall-oil, C12-15-alkyl esters, sulfated, sodium salts",68424-50-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3bb97b19-2380-48ba-87bb-08aeade68f5a/documents/IUC5-fc7c2f8d-4726-4990-9f26-c6264ccf7b07_46761a5c-80c0-4c34-b188-b8cdf9ac4c6b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, tall-oil, C12-15-alkyl esters, sulfated, sodium salts",68424-50-0,LD50 oral > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bb97b19-2380-48ba-87bb-08aeade68f5a/documents/IUC5-e4e419f3-53dc-42d5-936b-b43a4511ef73_46761a5c-80c0-4c34-b188-b8cdf9ac4c6b.html,,,,,, "Fatty acids, tall-oil, C12-15-alkyl esters, sulfated, sodium salts",68424-50-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bb97b19-2380-48ba-87bb-08aeade68f5a/documents/IUC5-e4e419f3-53dc-42d5-936b-b43a4511ef73_46761a5c-80c0-4c34-b188-b8cdf9ac4c6b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, C12-15-alkyl esters, sulfated, sodium salts",68424-50-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bb97b19-2380-48ba-87bb-08aeade68f5a/documents/IUC5-e4e419f3-53dc-42d5-936b-b43a4511ef73_46761a5c-80c0-4c34-b188-b8cdf9ac4c6b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, compds. with diethanolamine",61790-66-7," Oral (28 days) A study was conducted to evaluate the repeated dose oral toxicity of the read across substance, C12-18 and C18-unsatd. DEA, according to a design based on OECD Guideline 407. Groups of 10 male and 10 female Wistar rats were orally gavaged with the substance diluted in olive oil, 5 d/week for 28 d at doses of 0, 70, 250, 750 (Days 1-14) and 1500 (Days 15-28) mg/kg bw/d. Clinical signs, bodyweight, haematology, clinical chemistry, urinalysis, gross and microscopic pathology were recorded. Additional groups of 5 male and 5 female rats were kept for a 4 month recovery period. No treatment-related adverse effects were observed at any of the doses. Changes in the forestomach at some doses including controls were attributed to the use of olive oil and found to be reversible after end of exposure. Under the study conditions, the 28 d NOAEL to rats was considered to be >750 mg/kg bw/day (Potokar, 1983). Oral (Combined repeated dose and reproductive/developmental screen) A study was conducted to evaluate the repeated dose oral toxicity of the read across substance, C18-unsatd. MIPA, according to OECD Guideline 422, in compliance with GLP. Groups of ten male and ten female Sprague-Dawley rats received the read across substance at dose-levels of 0, 100, 300 or 1000 mg/kg bw/day daily by oral (gavage) administration 2 weeks before mating, during mating, gestation and until up to Day 5 p.p. The concentration of the dose formulation was checked in study Weeks 1, 3 and 6. The animals were checked at least twice daily during the dosing period for mortality and morbidity and once daily for clinical signs. Detailed clinical observations were performed once a week. Body weight and food consumption were recorded once a week during premating and mating periods (food consumption not during mating), and during gestation on Days 0, 7, 14 and 20 p.c. and lactation on Days 1 and 5 p.p. The animals were paired for mating after 2 weeks of treatment and the females were allowed to litter and rear their progeny until Day 5 p.p. The total litter sizes and the sex of each pup were recorded after birth. The pups were observed daily for clinical signs, abnormal behaviour and external abnormalities and weighed on Days 1 and 5 p.p. At the end of the treatment period, Functional Observation Battery, motor activity and laboratory investigations (hematology and blood biochemistry) were carried out on five males and five females. The males were sacrificed after at least 5 weeks of treatment and the females on Day 6 p.p. Final body weights and selected organs weights (adrenals, brain, epididymides, heart, kidneys, liver, spleen, testes and thymus) were recorded and a complete macroscopic post-mortem examination was performed, with particular attention paid to the reproductive organs. A microscopic examination was performed on selected organs from five males and five females in the control- and high-dose groups, on liver, thymus, seminal vesicles and bone marrow from five males and/or five females in the low- and intermediate-dose groups and on all macroscopic lesions. The pups were sacrificed on Day 5 p.p. and submitted for a macroscopic post-mortem examination of the principal thoracic and abdominal organs. The read across substance concentrations checked during the study were within an acceptable range of variations when compared to the nominal values (± 15%). There was no read across substance in control formulations. There were no read across substance-related deaths. Clinical signs consisted of ptyalism in all animals at 300 and 1000 mg/kg bw/day and in most of the animals at 100 mg/kg bw/day (minor toxicological significance), as well as hypoactivity, loud breathing, piloerection and/or round back observed in a few animals at 300 and 1000 mg/kg bw/day for a few days (limited toxicological significance). There were no relevant effects on mean body weight, mean Functional Observation Battery (FOB), as well as on mean hematology parameters in any group and sex. An effect of the read across substance treatment on mean motor activity data at 300 and/or 1000 mg/kg bw/day was considered to be equivocal but of limited toxicological significance. In males, mean food consumption at 1000 mg/kg bw/day was reduced in the first week of treatment only (23 g/male/day, vs. 27, p<0.001). This effect was considered to be of limited toxicological significance. Mean food consumption in males at 100 and 300 mg/kg bw/day and in females were not affected. In females, mean cholesterol level was higher than in controls at 300 and 1000 mg/kg bw/day (up to 1.9 mmol/L, vs.1.2, p<0.01) and considered to be non-adverse in absence of adverse correlates in the study. There were no relevant blood biochemistry findings in females at 100 mg/kg bw/day or in males. At histopathology at 1000 mg/kg bw/day, minimal hepatocellular hypertrophy correlating with higher mean liver weight was seen in the liver of both sexes (about +28% in males and +20% in females compared to controls, p<0.01 generally). In females, mild lymphoid atrophy was seen in the thymus of 2/5 females, correlating with lower mean weight at necropsy (about -22% from controls). At 300 mg/kg bw/day, only minimal hepatocellular hypertrophy was seen in the liver of a single male correlating with minor higher mean absolute weight in this group. All these microscopic findings were considered to be non-adverse (low number of animals affected and/or minimal to slight grades). There were no histopathological effects at 100 mg/kg bw/day. Under the study conditions, the NOAEL for parent systemic toxicity was considered to be 1000 mg/kg bw/day (Bentz, 2013).  Also,after discussion with ECHA in the frame of a Dossier Improvement Action Plan (DIAP),a combined repeated dose toxicity testing/reproductive and developmental screening according to OECD Guideline 422 is planned with C16-18 and C18-unsatd. DEA in order to further support the read across approach proposed for the FAA category members. Oral (90 day) A study was conducted to evaluate the repeated dose oral toxicity of the read across substance, C12 DEA. The rats were administered read across substance concentrations of 0, 0.1, 0.5, 1 and 2% in diet for 90 d. The animals were observed daily for clinical signs. Body weight were recorded weekly and haematological, clinical chemistry and urine examinations were carried out at termination. Gross and histopathological examinations were also performed at termination. No adverse effect on the appearance or condition of the animals was observed. Growth retardation was associated with diminished food intake from the dose level of 0.5%. Food refusal was demonstrably due to an effect of the test material on palatability of the diet. Terminal haematological examination revealed a reduction in the haemoglobin level, haematocrit and red cell count at the 1 and 2% dose levels in females but less pronounced effects were seen in males. Serum levels of glutamic-oxaloacetic transaminase were elevated at 0.5% and above in females but only at 0.5 % in males. No untoward effect was observed in the renal function tests. The principal organ weight changes were: increases in the relative kidney weight in all test groups except at 0.1% in females and at 0.1 and 0.5% in males, and increases in the relative liver weight in females on the two highest levels. The types and incidence of histological lesions were comparable in control and test groups. Under the study conditions, the 90 d NOEL in rats was considered to be 0.1% in the diet, equivalent to 50 mg/kg bw/day (Gaunt, 1965). Furthermore,after discussion with ECHA in the frame of a Dossier Improvement Action Plan (DIAP),a testing proposal is submitted for the conduct of repeated dose toxicity study according to OECD Guideline 408 with the read across substance, C8-18 and C18-unsatd. DEA. Dermal (14 weeks)   A study was conducted to evaluate the repeated dose dermal toxicity in mice of the read across substance, C8-18 and C18-unsatd. DEA, according to a design based on OECD Guideline 411, in compliance with GLP. Groups of 10 male and 10 female B6C3F1mice were exposed to 0, 50, 100, 200, 400 or 800 mg/kg bw/day of the substance in ethanol by dermal application, 5 times per week, for 14 weeks. Mortality, clinical signs and bodyweight were recorded throughout the study. At the end of the study, samples were collected for sperm motility and vaginal cytology evaluations in the 0, 200, 400 and 800 mg/kg bw/day dose groups. At necropsy, a gross macroscopic examination was conducted. Selected organs were weighed and a complete histopathological evaluation was carried out for 0 and 800 mg/kg bw/day mice. All mice survived until the end of the study. The only treatment related clinical finding was irritation of the skin at the site of application in males and females administered 800 mg/kg bw/day. There were no effects on body weight. Weights of the liver and kidney of 800 mg/kg bw/day males and females, liver of 400 mg/kg bw/day females and lung of 800 mg/kg bw/day females were significantly increased compared to the controls. Epididymal spermatozoa concentration was significantly increased in 800 mg/kg bw/day males. Histopathologic lesions of the skin at the site of application included epidermal hyperplasia, sebaceous gland hyperplasia, chronic active inflammation, parakeratosis and ulcer. The incidences and severities of these skin lesions generally increased with increasing dose in males and females. Under the study conditions, the 14-week NOAEL in mice for systemic effects was considered to be 200 mg/kg bw/day and for the local effects 100 mg/kg bw/day (NTP, 2001).   A study was conducted to evaluate the repeated dose toxicity in rats of the read across substance, C8-18 and C18-unsatd. DEA, according to a design based on OECD Guideline 411, in compliance with GLP. Groups of 10 male and 10 female Fischer 344 rats were exposed to 0, 25, 50, 100, 200 or 400 mg/kg bw/day of the substance in ethanol by dermal application, 5 times per week, for 14 weeks. Mortality, clinical signs and bodyweight were recorded throughout the study. Blood was collected on days 4 and 24 for hematology and clinical chemistry analysis. At the end of the study, samples were collected for sperm motility and vaginal cytology evaluations in the 0, 100, 200 or 400 mg/kg bw/day dose groups. At necropsy, a gross macroscopic examination was conducted. Selected organs were weighed and a complete histopathological evaluation was carried out for 0 and 400 mg/kg/day rats. All rats survived until the end of the study. Clinical findings included irritation of the skin at the site of application in 100, 200 and 400 mg/kg bw/day males and females. Final mean bodyweights and bodyweight gains of 200 and 400 mg/kg bw/day males and females were significantly lower than those of the controls. At week 14, a minimal microcytic, normochromic, non-responsive anaemia occurred in the 100 and 200 mg/kg bw/day females and 400 mg/kg bw/day males and females. The anaemia was also seen in the 400 mg/kg bw/day males and females on day 24. Increased segmented neutrophil counts occurred in 400 mg/kg bw/day males and females at week 14 and in 400 mg/kg bw/day females on day 24. Cholesterol concentrations were significantly decreased in 200 and 400 mg/kg bw/day males and in females administered 100 mg/kg bw/day or greater. Triglyceride concentrations were decreased in 200 and 400 mg/kg bw/day males. Histopathological lesions of the skin at the site of application included epidermal hyperplasia, sebaceous gland hyperplasia, chronic active inflammation, parakeratosis and ulcer. The incidence and severity of these skin lesions generally increased with increasing dose in males and females. The incidences of renal tubule regeneration in 100, 200 and 400 mg/kg bw/day females were significantly greater than in controls, and the severity in 200 and 400 mg/kg bw/day females was increased. Under the study conditions, the 14-week systemic NOAEL in rats was considered to be 50 mg/kg bw/day (NTP, 2001).  Dermal (2 years)  A study was conducted to evaluate the long-term repeated dose dermal toxicity to B6C3F1 mice of the read across substance, C8-18 and C18-unsatd. DEA, in compliance with GLP. The doses studied included 0, 100 and 200 mg/kg bw/day of read across substance (corresponding to 0, 50, or 100 mg/mL in ethanol). Fifty male/female test animals were used in each group. Five exposures per week were administered for 104 to 105 weeks. The animals were observed twice daily, and body weights and clinical findings were recorded periodically. All animals were necropsied and complete histopathology was performed. Survival of dosed male and female mice was generally similar to that of the vehicle controls. The mean bodyweights of the 100 mg/kg bw/day females from week 93 and of the 200 mg/kg bw/day females from week 77 were lower than those of the vehicle controls. The only clinical finding attributed to treatment was an irritation of the skin at the site of application in males administered 200 mg/kg bw/day. The incidences of hepatic neoplasms (hepatocellular adenoma, hepatocellular carcinoma and hepatoblastoma) were significantly increased in male and/or female mice. The number of eosinophilic foci in dosed groups of male mice was higher than in the vehicle controls. The occurrences of renal tubule adenoma and renal tubule adenoma or carcinoma (combined) were significantly increased in 200 mg/kg bw/day males. Several non-neoplastic lesions of the skin at the site of application were considered treatment-related. Incidences of epidermal hyperplasia, sebaceous gland hyperplasia and hyperkeratosis were greater in all dosed groups than in the vehicle controls and the number of thyroid gland follicular cell hyperplasia in all dosed groups was also significantly greater than those in the vehicle control groups. There was clear evidence of carcinogenic activity in male B6C3F1 mice based on increased incidences of hepatic and renal tubule neoplasms and in female B6C3F1 mice based on increased incidences of hepatic neoplasms. These increases were associated with the concentration of free diethanolamine present as a contaminant in the read across substance. However, recent evidences suggest that DEA should not be classified as a carcinogen, as the hepatic tumours seen in mice and the proposed mode of non-genotoxic mechanism for renal/liver tumours are not relevant to humans/primates. Under the study conditions, the 2-yr LOAEL was considered to be 100 mg/kg bw/day in mouse (NTP, 2001).   A study was conducted to evaluate the long-term repeated dose dermal toxicity to Fischer 344 rats of the read across substance, C8-18 and C18-unsatd. DEA, in compliance with GLP. Groups of 50 male and 50 female rats were exposed to 0, 50 or 100 mg/kg bw/day of the substance in ethanol by dermal application, 5 times per week, for 104 weeks. Mortality, clinical signs and bodyweight were recorded throughout the study. At necropsy, a gross macroscopic examination and complete histopathology were carried out. The survival rates of treated male and female rats were similar to those of controls. There were no significant differences in bodyweight throughout the groups. The only treatment-related clinical finding was irritation of the skin at the site of application in 100 mg/kg bw/day females. Non-neoplastic lesions of the skin at the site of application included epidermal hyperplasia, sebaceous gland hyperplasia, parakeratosis and hyperkeratosis, and the incidences and severities of these lesions increased with increasing dose. There were marginal increases in the incidences of renal tubule adenoma or carcinoma (combined) in 50 mg/kg bw/day females. The severity of nephropathy increased with increasing dose in female rats. The incidences of chronic active inflammation, epithelial hyperplasia and epithelial ulcer of the forestomach increased with dose in female rats and the increases were significant in the 100 mg/kg bw/day group. Under the study conditions, there was no evidence of carcinogenic activity of the read across substance in male rats at any dose. There was an equivocal evidence of carcinogenic activity in female rats based on a marginal increase in the incidences of renal tubule neoplasms. However, the absence of an increase in neoplasms in the 100 mg/kg bw/day group in the presence of increased hyperplasia makes the association with treatment uncertain. Under the study conditions, the 2-yr NOAEL was considered to be 50 mg/kg bw/day in rat (NTP, 2001). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0310dd59-bf5c-4586-94ea-b70ff3ecc823/documents/abe657b4-241e-445d-97cc-deeddb713fd0_8b2c08fc-b1c5-47ea-8f95-e1e3e41ab9e4.html,,,,,, "Fatty acids, tall-oil, compds. with diethanolamine",61790-66-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0310dd59-bf5c-4586-94ea-b70ff3ecc823/documents/abe657b4-241e-445d-97cc-deeddb713fd0_8b2c08fc-b1c5-47ea-8f95-e1e3e41ab9e4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Fatty acids, tall-oil, compds. with diethanolamine",61790-66-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0310dd59-bf5c-4586-94ea-b70ff3ecc823/documents/abe657b4-241e-445d-97cc-deeddb713fd0_8b2c08fc-b1c5-47ea-8f95-e1e3e41ab9e4.html,Chronic toxicity – systemic effects,dermal,NOAEL,50 mg/kg bw/day,,rat "Fatty acids, tall-oil, compds. with diethanolamine",61790-66-7," Oral A study was performed to assess the acute oral toxicity of the test substance, C16-18 and C18-unsatd. DEA, in Bor: WISW rats according to OECD Guideline 401. A group of 20 fasted animals (10 males and 10 females) were given a single oral dose of 3000 mg/kg bw undiluted test substance. The animals were observed for 14 d then sacrificed and subjected to gross pathological examination. There were no mortalities. Transient signs of toxicity were observed 30 minutes after dosing, but no longer after that time point. Upon necropsy, thickening of the mucous membrane of the forestomach and slight reddening of the mucous membrane of the stomach was seen in some animals. Under the study conditions, the LD50 of the test substance in rats was found to be >3000 mg/kg bw(Mürmann, 1990). Dermal A study was conducted to determine the acute dermal toxicity of the read across substance, C8-18 and C18-unsatd. DEA, in male/female New Zealand White rabbits. The procedure was the modification of the techniques described in Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics, compiled by the staff of the Division of Pharmacology, Food and Drug Administration. A single dose of 2000 mg/kg bw of test substance was applied to the abraded and intact skin of the test animals. The trunk of each animal was then encased in a sleeve of plasticized material for a 24 h period. Animals were observed immediately after dosing, and at 1, 6 and 24 h post-dosing. Following the 24 h exposure period, animals were observed for mortality, skin response and general behaviour for 14 d. No mortality occurred. All animals appeared normal throughout the 24 h exposure and 14 d post-exposure observation periods. Under the study conditions, the dermal LD50 in rabbits was found to be > 2000 mg/kg bw (Palanker, 1976). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0310dd59-bf5c-4586-94ea-b70ff3ecc823/documents/555063de-b25f-4629-946b-655862ab26ec_8b2c08fc-b1c5-47ea-8f95-e1e3e41ab9e4.html,,,,,, "Fatty acids, tall-oil, compds. with diethanolamine",61790-66-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0310dd59-bf5c-4586-94ea-b70ff3ecc823/documents/555063de-b25f-4629-946b-655862ab26ec_8b2c08fc-b1c5-47ea-8f95-e1e3e41ab9e4.html,,oral,LD50,"3,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, compds. with diethanolamine",61790-66-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0310dd59-bf5c-4586-94ea-b70ff3ecc823/documents/555063de-b25f-4629-946b-655862ab26ec_8b2c08fc-b1c5-47ea-8f95-e1e3e41ab9e4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, compds. with ethanolamine",68132-47-8, The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was found to be > 2000 mg/kg bw (OECD 420 and EU Method B.1 bis).. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10e3e9ec-2f4a-4e4b-b59a-56a7e1fb8fe1/documents/60636dc6-f32f-458a-9db4-f10724780aa3_f8f30657-4908-4604-af00-0fb34c442ab7.html,,,,,, "Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides",92128-22-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study is GLP compliant and is of high quality (Klimisch score=1) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d299c9c-1d04-4a7d-afd9-e3d4a8e1f08f/documents/160a0da7-c317-400b-ad36-3dfaed7055c3_893b971a-db3f-4987-8316-682853c100ad.html,,,,,, "Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides",92128-22-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d299c9c-1d04-4a7d-afd9-e3d4a8e1f08f/documents/160a0da7-c317-400b-ad36-3dfaed7055c3_893b971a-db3f-4987-8316-682853c100ad.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides",92128-22-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is of sufficient quality (Klimisch score=2) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study is GLP compliant and is of high quality (Klimisch score=1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d299c9c-1d04-4a7d-afd9-e3d4a8e1f08f/documents/2d7a85a1-69f5-44ef-b713-042e341bc1d1_893b971a-db3f-4987-8316-682853c100ad.html,,,,,, "Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides",92128-22-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d299c9c-1d04-4a7d-afd9-e3d4a8e1f08f/documents/2d7a85a1-69f5-44ef-b713-042e341bc1d1_893b971a-db3f-4987-8316-682853c100ad.html,,oral,LD50,"> 4,600 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, compds. with N-[3-(dimethylamino)propyl]tall-oil amides",92128-22-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d299c9c-1d04-4a7d-afd9-e3d4a8e1f08f/documents/2d7a85a1-69f5-44ef-b713-042e341bc1d1_893b971a-db3f-4987-8316-682853c100ad.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, esters with dipentaerythritol",70913-98-3,"Repeated dose toxicity: Oral NOAEL (rat, m/f): 1000 mg/kg bw/day (OECD 408, GLP analogue approach)Repeated dose toxicity: Inhalation NOAEC (rat, m/f): 0.5 mg/L (OECD 413, analogue approach)Repeated dose toxicity: Dermal NOAEL (rat, m/f): 2000 mg/kg bw/day (OECD 411, analogue approach) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56ecfe0f-9d1e-4b0f-a414-985023b56435/documents/IUC5-605ed615-c7d7-4942-a02a-048e1b8f1f07_4cb08d45-49e6-4f7c-89ef-a9824f44caef.html,,,,,, "Fatty acids, tall-oil, esters with dipentaerythritol",70913-98-3,"Acute toxicity: Oral LD50 (rat, m/f): > 2000 mg/kg bw (OECD 401, analogue approach)Acute toxicity: Dermal LD50 (rat, m/f): > 2000 mg/kg bw (OECD 402, analogue approach)Acute toxicity: Inhalation LC50 (rat, m/f): > 5.1 mg/L air (OECD 403, analogue approach) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56ecfe0f-9d1e-4b0f-a414-985023b56435/documents/IUC5-5a305716-7950-4407-a91b-2eb9b5b79c2d_4cb08d45-49e6-4f7c-89ef-a9824f44caef.html,,,,,, "Fatty acids, tall-oil, iron salts",61788-81-6," The hazard information on the substance is based on read across from Tall oil and 2-ethylhexanoic acid and reveals low toxicity. Furthermore, the source substances contain higher or similar concentrations of the constituents used for read across compared to the target substance. There are no scientific reasons indicating that the constituents of the substance can interact in a way that will influence the toxicological/ecotoxicological properties of the substance. The parental NOEL was considered to be 1000 p.p.m. For reproductive parameters the NOEL was considered to be 5000 p.p.m ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0d6c831-d8f7-4111-a77e-0d00943f5c90/documents/24703b35-0346-4fb3-9f3a-1441ce04027d_b2c15481-2bd4-4ede-81aa-0b95d7b8d3cd.html,,,,,, "Fatty acids, tall-oil, iron salts",61788-81-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0d6c831-d8f7-4111-a77e-0d00943f5c90/documents/24703b35-0346-4fb3-9f3a-1441ce04027d_b2c15481-2bd4-4ede-81aa-0b95d7b8d3cd.html,Chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,, "Fatty acids, tall-oil, iron salts",61788-81-6," The hazard information on the substance is based on read across from Tall oil and 2-ethylhexanoic acid and reveals low toxicity. Furthermore, the source substances contain higher or similar concentrations of the constituents used for read across compared to the target substance. There are no scientific reasons indicating that the constituents of the substance can interact in a way that will influence the toxicological/ecotoxicological properties of the substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0d6c831-d8f7-4111-a77e-0d00943f5c90/documents/fa34e33b-72fd-4669-b928-8a60ab020123_b2c15481-2bd4-4ede-81aa-0b95d7b8d3cd.html,,,,,, "Fatty acids, tall-oil, iron salts",61788-81-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0d6c831-d8f7-4111-a77e-0d00943f5c90/documents/fa34e33b-72fd-4669-b928-8a60ab020123_b2c15481-2bd4-4ede-81aa-0b95d7b8d3cd.html,,oral,,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, iron salts",61788-81-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0d6c831-d8f7-4111-a77e-0d00943f5c90/documents/fa34e33b-72fd-4669-b928-8a60ab020123_b2c15481-2bd4-4ede-81aa-0b95d7b8d3cd.html,,dermal,,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, low-boiling",65997-03-7,"Based on available data for groups of constituents present in Tall Oil Heads, a conservative 2-year NOAEL of >200 mg/kg/d is set for the oral route. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/752cdcbc-bfc8-4747-b443-e8fd7a4d0d17/documents/IUC5-8f01d703-7af0-41ed-8fe3-52c03fab44db_9215974a-8f6e-480c-8b5d-a77651ff9dde.html,,,,,, "Fatty acids, tall-oil, low-boiling",65997-03-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/752cdcbc-bfc8-4747-b443-e8fd7a4d0d17/documents/IUC5-8f01d703-7af0-41ed-8fe3-52c03fab44db_9215974a-8f6e-480c-8b5d-a77651ff9dde.html,Chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Fatty acids, tall-oil, low-boiling",65997-03-7,"No acute toxicity data are available for Tall Oil Heads. However, good quality, reliable data are available for the two related substances Crude Tall Oil (CAS 8002-26-4) and Tall Oil Pitch (CAS 8016-81-7). A weight of evidence approach is therefore used to fill data gaps for Tall Oil Heads.The key acute oral toxicity study for Crude Tall Oil gave an LD50 (oral) >2000 mg/kg bw (OECD 423, acute toxic class method) in rats (Wolf, 2005). There were no clinical signs or necropsy findings. For Tall Oil Pitch, an acute oral LD50 value >2000 in rats was determined in a study conducted in accordance with OECD 425 (up & down method) and in compliance with GLP (inveresk, 2002). There were no mortalities or other treatment-related findings in the study. It can therefore be concluded that the acute oral LD50 for Tall Oil Heads is >2000 mg/kg. The key acute dermal toxicity study for Crude Tall Oil gave an LD50 (dermal) >2000 mg/kg bw (OECD 402, limit test) in rats (Bernat, 2005). There were no clinical signs, signs of local irritation or necrospy findings. For Tall Oil Pitch, an acute dermal LD50 >2000 in rats was determined in a study carried out in accordance with OECD 402 and in compliance with GLP (ARC, 2005a). There were no mortalities, treatment-related systemic effects or local effects during the study. It can therefore be concluded that the acute dermal LD50 for Tall Oil Heads is >2000 mg/kg. No data are available for the inhalation route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/752cdcbc-bfc8-4747-b443-e8fd7a4d0d17/documents/IUC5-6cfdb5af-b4d2-45b1-a057-5b331f81d0ac_9215974a-8f6e-480c-8b5d-a77651ff9dde.html,,,,,, "Fatty acids, tall-oil, low-boiling",65997-03-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/752cdcbc-bfc8-4747-b443-e8fd7a4d0d17/documents/IUC5-6cfdb5af-b4d2-45b1-a057-5b331f81d0ac_9215974a-8f6e-480c-8b5d-a77651ff9dde.html,,oral,LD50,"2,000 mg/kg bw",, "Fatty acids, tall-oil, low-boiling",65997-03-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/752cdcbc-bfc8-4747-b443-e8fd7a4d0d17/documents/IUC5-6cfdb5af-b4d2-45b1-a057-5b331f81d0ac_9215974a-8f6e-480c-8b5d-a77651ff9dde.html,,dermal,LD50,"2,000 mg/kg bw",, "Fatty acids, tall-oil, magnesium salts",67701-23-9," The hazard information on the substance is based on read across from Tall oil and 2-ethylhexanoic acid and reveals low toxicity. Furthermore, the source substances contain higher or similar concentrations of the constituents used for read across compared to the target substance. There are no scientific reasons indicating that the constituents of the substance can interact in a way that will influence the toxicological/ecotoxicological properties of the substance. The parental NOEL was considered to be 1000 p.p.m. For reproductive parameters the NOEL was considered to be 5000 p.p.m ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc4a8589-238b-4fe5-be86-38f1c33683fd/documents/10c01ea1-af3e-4dc0-b1f1-6e15706f9ebd_1131bf90-1a95-44a6-8b5c-43f126c0a629.html,,,,,, "Fatty acids, tall-oil, magnesium salts",67701-23-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc4a8589-238b-4fe5-be86-38f1c33683fd/documents/10c01ea1-af3e-4dc0-b1f1-6e15706f9ebd_1131bf90-1a95-44a6-8b5c-43f126c0a629.html,Chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,, "Fatty acids, tall-oil, magnesium salts",67701-23-9," The hazard information on the substance is based on read across from Tall oil and 2-ethylhexanoic acid and reveals low toxicity. Furthermore, the source substances contain higher or similar concentrations of the constituents used for read across compared to the target substance. There are no scientific reasons indicating that the constituents of the substance can interact in a way that will influence the toxicological/ecotoxicological properties of the substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc4a8589-238b-4fe5-be86-38f1c33683fd/documents/3bc04208-f764-4279-abd1-7b9a01639b70_1131bf90-1a95-44a6-8b5c-43f126c0a629.html,,,,,, "Fatty acids, tall-oil, magnesium salts",67701-23-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc4a8589-238b-4fe5-be86-38f1c33683fd/documents/3bc04208-f764-4279-abd1-7b9a01639b70_1131bf90-1a95-44a6-8b5c-43f126c0a629.html,,oral,,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, magnesium salts",67701-23-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc4a8589-238b-4fe5-be86-38f1c33683fd/documents/3bc04208-f764-4279-abd1-7b9a01639b70_1131bf90-1a95-44a6-8b5c-43f126c0a629.html,,dermal,,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, manganese salts",8030-70-4,"Oral route: A subchronic oral toxicity study (OECD 408) with fatty acids, tall-oil, manganese salts (MnTall) is available. Fatty acids, tall-oil, manganese salts, in peanut oil as vehicle, administered orally by gavage for 90 consecutive days to Wistar rats (0, 40, 200, 1000 mg MnTall/kg bw/day) did cause a dose dependent increase of the body weight-adjusted liver weights in both sexes in the mid and high dose groups, showing statistical significance in high dose-treated males and females and in mid dose-treated females. However, in this study no test item related toxicologically relevant effects were observed on the behaviour, body weight or body weight gain of the animals. No changes were observed at the ophthalmoscopic examination, no consequences were noted at the neurobehavioural examinations. Clinical pathology tests did not show any test item-related effect in the hematopoietic system. Necropsy and histopathological investigation of the examined organs and tissues did not reveal any test item-related pathological signs. As this elevation in the related liver weight was rather minor and was not accompanied by any morphological change in the organ or any changes in liver function, this elevation can be considered as rather adaptive, but not adverse. Further, a statistically significantly higher than control urea plasma concentration in mid and high dose-treated males and in high dose-treated females, and a statistically significantly higher than control plasma phosphorus concentration in high dose-treated males, together with the significant increase in body weight-related kidney weight of the high dose-treated females, was observed and showed a test item-related, pathophysiological impact on kidney function. The NOAEL for rats was established in males as 40 mg MnTall/kg bw/day and in females as 200 mg MnTall/kg bw/day.   Inhalation route: There is no repeated dose inhalation toxicity study with fatty acids, tall-oil, manganese salts available, thus the repeated dose inhalation toxicity will be addressed with existing data on the individual moieties manganese and tallate. Since naturally occurring fatty acids are void of any human health hazard potential, the hazard assessment will be derived based on the toxicological information for manganese. Thus, due to adverse effects observed in long-term inhalation studies with manganese salts and considering the read-across principles for fatty acids, tall-oil, manganese salts based on the toxicological assessment of the individual moieties, it is proposed to also read-across the classification of Specific Target Organ Toxicity - Repeated Exposure, category 2 based on neurological effects (H373- brain, inhalation) of manganese sulphate to fatty acids, tall-oil, manganese salts. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c409e64b-5f2c-4639-8a73-e58ac0db69f7/documents/07b3ff10-a2ab-4a6a-ad3e-f34e98b62f32_ac9c6679-276f-4759-b997-f30bc4181253.html,,,,,, "Fatty acids, tall-oil, manganese salts",8030-70-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c409e64b-5f2c-4639-8a73-e58ac0db69f7/documents/07b3ff10-a2ab-4a6a-ad3e-f34e98b62f32_ac9c6679-276f-4759-b997-f30bc4181253.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Fatty acids, tall-oil, manganese salts",8030-70-4,"An acute oral toxicity study is available with Fatty acids, tall-oil, manganese salts, resulting in a LD50 of >2000 mg/kg bw. Acute dermal and inhalation toxicity are addressed with existing data on the dissociation products manganese and tallate. Signs of acute dermal toxicity are not expected for fatty acids, tall-oil, manganese salts, since the two assessment entities manganese and tallate do not show signs of acute dermal toxicity in experimental testing (both LD50 > 2000mg/kg). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c409e64b-5f2c-4639-8a73-e58ac0db69f7/documents/c7462983-6ba9-4ade-94f6-2c3dba5fdf77_ac9c6679-276f-4759-b997-f30bc4181253.html,,,,,, "Fatty acids, tall-oil, manganese salts",8030-70-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c409e64b-5f2c-4639-8a73-e58ac0db69f7/documents/c7462983-6ba9-4ade-94f6-2c3dba5fdf77_ac9c6679-276f-4759-b997-f30bc4181253.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts",160901-14-4," Key data is available for Fatty acids, tall oil, oligomeric reaction products with maleaic anhydride and rosin, calcium, magnesium, zinc salts from a Guideline (OECD 422) combined repeated dose, reproductive/developmental toxicity screening study. Additionally, key Guideline (OECD 408, & 414) studies that investigated the repeated dose toxicity potential of Rosin, maleated, a structural analogue following oral dietary exposure in rats are available. The results are summarized below:   OECD 408   1) Rosin, Maleated (CAS# 8050-28-0): The No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be 1500 ppm (equivalent to a mean achieved dosage of 99.5 and 120.4 mg/Kg bw/day for males and females respectively due to reduced bodyweight gains and food consumption and adverse histopathological changes in the urinary bladder of both sexes exposed to a dietary concentration of 3000 ppm of the test material.   OECD 422   1) Fatty acids, tall-oil, oligomeric reaction products with maleic anhydride and rosin, calcium, magnesium, zinc salts (CAS# 160901-14-4): The NOAEL (No Observed Adverse Effect Level) for systemic toxicity was established at a concentration of 15000 ppm (equivalent to mean achieved dosages of 761.3 mg/Kg bw/day (pre-pairing) and 769.9 mg/Kg bw/day (post-pairing) in males and 746.7 mg/Kg bw/day (pre-pairing); 1141.2 mg/Kg bw/day (Gestation); and 1418.2 mg/Kg bw/day (Lactation) in females). The NOEL (No Observed Effect Level) was established at a concentration of 1000 ppm.   OECD 414  1) Rosin, maleated (CAS# 8050-28-0): The No Observed Effect Level (NOEL) for the pregnant dam was determined to be 500 ppm (equivalent to an achieved dosage of approximately 41.2 mg/Kg bw/day of the test material). The No Observed Adverse Effect Level (NOAEL) for the pregnant dam was considered to be a dietary exposure to 1500 ppm (equivalent to an achieved dosage of approximately 122.9 mg/Kg bw/day of the test material), based on effects observed on body weight gain and food consumption at a dietary concentration of 3000 ppm. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/abefee66-396e-43c4-8ac7-aeabb18eab59/documents/b6001917-803a-4a44-9645-f603c31bf108_8416953d-28d5-4f17-afb0-f12939143a45.html,,,,,, "Fatty acids, tall-oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts",160901-14-4,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/abefee66-396e-43c4-8ac7-aeabb18eab59/documents/b6001917-803a-4a44-9645-f603c31bf108_8416953d-28d5-4f17-afb0-f12939143a45.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,99.5 mg/kg bw/day,,rat "Fatty acids, tall-oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts",160901-14-4,Not acutely toxic following oral exposure (LD50 >2000 mg/kg bw). A low vapour pressure indicates that inhalation exposure is unlikely. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abefee66-396e-43c4-8ac7-aeabb18eab59/documents/c5c689e4-083b-4497-9ada-fa68b81a2624_8416953d-28d5-4f17-afb0-f12939143a45.html,,,,,, "Fatty acids, tall-oil, oligomeric reaction products with maleic anhydride and rosin, calcium magnesium zinc salts",160901-14-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abefee66-396e-43c4-8ac7-aeabb18eab59/documents/c5c689e4-083b-4497-9ada-fa68b81a2624_8416953d-28d5-4f17-afb0-f12939143a45.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall oil, reaction products with glycidyl neodecanoate",80207-00-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Good quality database ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd6cc4f7-e742-4683-bbdd-45abdc05c9b5/documents/e0563ef6-bac1-4ff9-9375-61db2a2d9437_f4e55c25-5706-4d04-b1f2-94fbafcb12e1.html,,,,,, "Fatty acids, tall oil, reaction products with glycidyl neodecanoate",80207-00-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd6cc4f7-e742-4683-bbdd-45abdc05c9b5/documents/e0563ef6-bac1-4ff9-9375-61db2a2d9437_f4e55c25-5706-4d04-b1f2-94fbafcb12e1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Fatty acids, tall oil, reaction products with glycidyl neodecanoate",80207-00-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): High quality ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd6cc4f7-e742-4683-bbdd-45abdc05c9b5/documents/IUC5-034dc3b3-074e-492f-9058-c1177a6f0f00_f4e55c25-5706-4d04-b1f2-94fbafcb12e1.html,,,,,, "Fatty acids, tall oil, reaction products with glycidyl neodecanoate",80207-00-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd6cc4f7-e742-4683-bbdd-45abdc05c9b5/documents/IUC5-034dc3b3-074e-492f-9058-c1177a6f0f00_f4e55c25-5706-4d04-b1f2-94fbafcb12e1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, reaction products with acrylic acid",1469983-44-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6560e0e5-6334-481c-b2a9-383eee092607/documents/IUC5-2e04fd64-67a5-4b9e-adc6-badf26c26d11_b79f3618-6c3f-41b6-80bc-1dc6422e0ef6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,271 mg/kg bw/day,,rat "Fatty acids, tall-oil, reaction products with acrylic acid",1469983-44-5,Acute oral toxicity study (standard acute method): LD50 6176 mg/kg bw (rat) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6560e0e5-6334-481c-b2a9-383eee092607/documents/IUC5-6de0ea9b-b902-4ed5-a8ef-f04637efc829_b79f3618-6c3f-41b6-80bc-1dc6422e0ef6.html,,,,,, "Fatty acids, tall-oil, reaction products with acrylic acid",1469983-44-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6560e0e5-6334-481c-b2a9-383eee092607/documents/IUC5-6de0ea9b-b902-4ed5-a8ef-f04637efc829_b79f3618-6c3f-41b6-80bc-1dc6422e0ef6.html,,oral,LD50,"6,176 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, reaction products with bisphenol A, epichlorohydrin, glycidyl tolyl ether and triethylenetetramine",186321-96-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/158d0c08-bbca-468b-9e61-eb53efcb856f/documents/IUC5-f291f22f-1003-4132-8685-2bea9d0e803e_623919c4-9252-4cbc-b296-22cf8b35b91e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Fatty acids, tall-oil, reaction products with bisphenol A, epichlorohydrin, glycidyl tolyl ether and triethylenetetramine",186321-96-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/158d0c08-bbca-468b-9e61-eb53efcb856f/documents/IUC5-fc8f480f-43d5-4e3c-838d-266f6cd5a0c1_623919c4-9252-4cbc-b296-22cf8b35b91e.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, reaction products with bisphenol A, epichlorohydrin, glycidyl tolyl ether and triethylenetetramine",186321-96-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/158d0c08-bbca-468b-9e61-eb53efcb856f/documents/IUC5-fc8f480f-43d5-4e3c-838d-266f6cd5a0c1_623919c4-9252-4cbc-b296-22cf8b35b91e.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine",91770-03-5," Oral route In a key OECD 408 Guideline (90-day repeat oral dose) study in rats treatment-related changes were observed in all animals at the 1000 mg/kg bw/day dose level. Effects noted in females at the 250 mg/kg bw/day dose level were considered not to be adverse therefore the NOAEL is considered to be 250 mg/kg bw/day. The NOEL for both sexes is 50 mg/kg bw/day. Dermal route In a key 28- day repeat dose dermal toxicity study performed according to OECD TG 410, no mortalities and no evidence of systemic toxicity was seen in any of the groups during the study. Evidence of mild dermal irritation (erythema after the first week of dosing and/or desquamation during the third and fourth week) was seen in two females at 100 mg/kg bw/day, one male and most females at 300 mg/kg bw/day and most animals at 1000 mg/kg bw/day. No severe dermal irritation or evidence of deep tissue damage was apparent. The NOAEL for systemic toxicity was determined to be 1000 mg/kg bw/day. The LOAEL for local effects was 100 mg/kg bw/day based on mild skin irritation observed in 1/5 females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85cd2429-04f7-418f-98d9-050e7c2acafb/documents/IUC5-24c3efcb-c7f4-4afe-815e-62446cb186d9_ff7cf190-5d91-4ac0-bad6-af95b9784d3d.html,,,,,, "Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine",91770-03-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85cd2429-04f7-418f-98d9-050e7c2acafb/documents/IUC5-24c3efcb-c7f4-4afe-815e-62446cb186d9_ff7cf190-5d91-4ac0-bad6-af95b9784d3d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine",91770-03-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85cd2429-04f7-418f-98d9-050e7c2acafb/documents/IUC5-24c3efcb-c7f4-4afe-815e-62446cb186d9_ff7cf190-5d91-4ac0-bad6-af95b9784d3d.html,Repeated dose toxicity – local effects,dermal,LOAEL,562 ,adverse effect observed, "Fatty acids, tall-oil, reaction products with boric acid (H3BO3) and diethanolamine",91770-03-5, Acute oral toxicity: The LD50 (rat) was > 5000 mg/kg bw (equivalent or similar to 16 CFR 1500.3). Acute inhalation toxicity: No data are available for the inhalation route. The substance is a liquid with a vapour pressure of 3.5 x 10E-04 Pa at 25 °C and is used primarily as a component of lubricants by workers and consumers. It is expected that inhalation exposure from these uses will be low and that the most likely route of exposure for workers and consumers is the dermal route. Acute dermal toxicity: The LD50 (rabbit) was > 2000 mg/kg bw (equivalent or similar to 16 CFR 1500.4). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85cd2429-04f7-418f-98d9-050e7c2acafb/documents/IUC5-b22274a9-b9b5-4ab9-9321-0242c0d57e61_ff7cf190-5d91-4ac0-bad6-af95b9784d3d.html,,,,,, "Fatty acids, tall-oil, reaction products with diethylenetriamine",61790-69-0," In a GLP-compliant acute oral toxicity study according to OECD Guideline 423, no mortality occurred and no clinical signs were seen at the limit dose of 2000 mg/kg bw. Therefore, the oral LD50 was calculated to be greater than 2000 mg/kg bw in rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/468aa3c3-2cd6-4d4e-a012-c48af4f439b0/documents/e2b014b5-90ce-4500-83b0-e7fdbdcff64e_9bd241b4-32c6-4b4b-bec6-26fd2d44e4ca.html,,,,,, "Fatty acids, tall-oil, reaction products with diethylenetriamine",61790-69-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/468aa3c3-2cd6-4d4e-a012-c48af4f439b0/documents/e2b014b5-90ce-4500-83b0-e7fdbdcff64e_9bd241b4-32c6-4b4b-bec6-26fd2d44e4ca.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, reaction products with diethylenetriamine, maleic anhydride, tetraethylenepentamine and triethylenetetramine",68990-47-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34cdabe4-a227-4608-8abd-9e941d2b5209/documents/081ce8a5-4bfb-4c57-9039-970e884ff3d3_a03df578-0b92-407d-8e81-37bf7942c473.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"> 1,000 mg/kg bw/day",,rat "Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated",61791-19-3,"No test-item related adverse effects were observed after daily oral administration of the test item for 4 weeks by gavage to rats up to the highest dose level tested (1000 mg/kg bw/d). The no observed adverse effect level (NOAEL) under the conditions of this study was 1000 mg/kg bw/d. Furthermore, a 28-day oral repeated dose toxicity study conducted with structurally similar, C12-18 and C18-unsatd. DEA in rats revealed a NOAEL of >750 mg/kg bw/d based on absence of treatment-related effects at any of the tested dose levels (please refer to ch. 13 for read-across justification). Regarding the dermal route, the following dose descriptors resulted from 90-d and 2-yr NTP studies: • Sub-chronic dermal rat: NOAEL (systemic effects): 100 mg/kg bw/d based on body weight, organ weight and clinical chemistry alterations at the ≥200 mg/kg bw/d; NOAEL (local effects): 25 mg/kg bw/d based on non-neoplastic lesions of the skin at ≥50 mg/kg bw/d. Sub-chronic dermal mouse LOAEL for systemic effects: 50 mg/kg bw/d based organ weight changes at ≥50 mg/kg bw/d; LOAEL for local effects: 50 mg/kg bw/d based on non-neoplastic lesion of the skin• Chronic dermal rat: NOAEL (systemic effects): 50 mg/kg bw/d based on BW changes at the LOAEL; LOAEL (local effects): 50 mg/kg bw/d based on non-neoplastic lesion of the skin at all tested doses. Chronic dermal mouse: NOAEL (systemic effects): 15 mg/kg bw/d based on body weight changes; LOAEL (local effects): 15 mg/kg bw/d based on non-neoplastic lesions of the skin. Giving preference to rat species as well as considering the highest NOAEL below the lowest LOAEL, the NOAEL for systemic effects of 50 mg/kg bw/d from the 2-yr study in rats will be used. For the local effects, since the 90-d and 2-yr rat studies results in LOAELs of 50 mg/kg bw/d this dose level will be further used. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/84945dee-f432-44fb-bbcf-a97e8305a6ff/documents/IUC5-40a2031e-4e4e-4db8-b454-d4c4870cf9cf_96bb82f4-f9d4-46b2-8e54-7956a49cace1.html,,,,,, "Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated",61791-19-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/84945dee-f432-44fb-bbcf-a97e8305a6ff/documents/IUC5-40a2031e-4e4e-4db8-b454-d4c4870cf9cf_96bb82f4-f9d4-46b2-8e54-7956a49cace1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated",61791-19-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/84945dee-f432-44fb-bbcf-a97e8305a6ff/documents/IUC5-40a2031e-4e4e-4db8-b454-d4c4870cf9cf_96bb82f4-f9d4-46b2-8e54-7956a49cace1.html,Chronic toxicity – systemic effects,dermal,NOAEL,50 mg/kg bw/day,,rat "Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated",61791-19-3,The test substance was tested in an acute oral toxicity study according to EU method B.1 bis cited as Directive 96/69/EEC in Wistar rats. No treatment related toxic effects were observed at the dose level of 2000 mg/kg bw. The acute oral discriminating does was determined to be 2000 mg/kg bw. The result is supported by an acute dermal study with a close homologue (please refer to ch. 13 for read-across justification) that led to the same result (LD50 > 2000 mg/kg). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84945dee-f432-44fb-bbcf-a97e8305a6ff/documents/IUC5-d18f5930-84fe-43d4-9499-783bca115c26_96bb82f4-f9d4-46b2-8e54-7956a49cace1.html,,,,,, "Fatty acids, tall-oil, reaction products with ethanolamine, ethoxylated",61791-19-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84945dee-f432-44fb-bbcf-a97e8305a6ff/documents/IUC5-d18f5930-84fe-43d4-9499-783bca115c26_96bb82f4-f9d4-46b2-8e54-7956a49cace1.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine",68911-83-1,Repeated dose toxicity: oral:Peter (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test in rats according to OECD guideline 422 (GLP). A Parental NOAEL of 100 mg/kg bw/day was derived. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d58c6a6d-3fc9-4739-8902-59100a8efd46/documents/IUC5-1fd27396-76cd-421d-9ab7-9477699d0615_5cafcf1b-109b-4471-a726-effec2e24545.html,,,,,, "Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine",68911-83-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d58c6a6d-3fc9-4739-8902-59100a8efd46/documents/IUC5-1fd27396-76cd-421d-9ab7-9477699d0615_5cafcf1b-109b-4471-a726-effec2e24545.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine",68911-83-1,"Acute toxicity: oralA K1 acute oral toxicity test was performed in male and female Sprague Dawley rats according to a guideline similar to OECD Guideline 401 (Gabriel, 1995). The acute oral LD50 value in male/female Sprague-Dawley rats was >2000 mg/kg bw.Acute toxicity: inhalationA K2 acute inhalation toxicity test was performed in male Sprague Dawley rats according to a guideline similar to OECD Guideline 403 (Gabriel, 1974). The acute oral 1-hr LC50 value in male Sprague-Dawley rats was 3.1 mg/L.Acute toxicity: dermalA K2 acute dermal toxicity test was performed in New Zealand whithe rabbit following the OECD 402 Guideline (Gabriel, 1974). The acute dermal LD50 value rabbits is > 8000 mg/kg bw.Acute toxicity: other routesNo reliable studies were available for this endpoint. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d58c6a6d-3fc9-4739-8902-59100a8efd46/documents/IUC5-31ae7255-65e8-4474-9f60-2856cb5e5238_5cafcf1b-109b-4471-a726-effec2e24545.html,,,,,, "Fatty acids, tall-oil, reaction products with formaldehyde and (Z)-N-9-octadecenyl-1,3-propanediamine",68911-83-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d58c6a6d-3fc9-4739-8902-59100a8efd46/documents/IUC5-31ae7255-65e8-4474-9f60-2856cb5e5238_5cafcf1b-109b-4471-a726-effec2e24545.html,,inhalation,LC50,"3,100 mg/m3",adverse effect observed, "Fatty acids, tall-oil, reaction products with pentaethylenehexamine",85940-40-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0148ad8-c4f9-42cb-92bf-08edbb8e7271/documents/IUC5-3685ad3a-0db9-46bf-b3be-4f5b7c03beac_361273d0-bca5-4d83-966b-33f8ca2422f8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Fatty acids, tall-oil, reaction products with pentaethylenehexamine",85940-40-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0148ad8-c4f9-42cb-92bf-08edbb8e7271/documents/IUC5-2d03d652-502c-4dbe-b066-80c2a0bc818d_361273d0-bca5-4d83-966b-33f8ca2422f8.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, reaction products with pentaethylenehexamine",85940-40-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0148ad8-c4f9-42cb-92bf-08edbb8e7271/documents/IUC5-2d03d652-502c-4dbe-b066-80c2a0bc818d_361273d0-bca5-4d83-966b-33f8ca2422f8.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tall-oil, reaction products with triethylenetetramine",68919-79-9,"Based on the absence of significant systemic effects observed in the combined screening study in rats, the NOAEL was determined at the highest tested dose of 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/883d4c17-607f-4a61-b983-0c78188d0249/documents/50457abf-0cd9-4a03-adde-d105d9f4514a_0f346a49-b620-4b55-befd-eac2a6ad757a.html,,,,,, "Fatty acids, tall-oil, reaction products with triethylenetetramine",68919-79-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/883d4c17-607f-4a61-b983-0c78188d0249/documents/50457abf-0cd9-4a03-adde-d105d9f4514a_0f346a49-b620-4b55-befd-eac2a6ad757a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"ca.1,000 mg/kg bw/day",,rat "Fatty acids, tall-oil, reaction products with triethylenetetramine",68919-79-9,"Based on the oral LD50 value, the test substance is considered to have a low acute toxicity potential.  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/883d4c17-607f-4a61-b983-0c78188d0249/documents/IUC5-72cd1b8f-71c9-4ec9-af82-c74cc4906e19_0f346a49-b620-4b55-befd-eac2a6ad757a.html,,,,,, "Fatty acids, tall-oil, reaction products with triethylenetetramine",68919-79-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/883d4c17-607f-4a61-b983-0c78188d0249/documents/IUC5-72cd1b8f-71c9-4ec9-af82-c74cc4906e19_0f346a49-b620-4b55-befd-eac2a6ad757a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tallow, calcium salts",64755-01-7,"Dose responsive localized dermal effects at the test site (dorsal surface), consisting of scabbed post dose findings and elevated dermal scores. These findings were most pronounced at 1000 mg/kg bw/day and were seen most frequently at this dose level. The findings at 300 mg/kg bw/day were at a lower incidence and with lower dermal scores. Dermal scores and findings at 100 mg/kg bw/day were comparable to the controls. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2033cf85-80fd-4e21-9083-fda849a033b9/documents/IUC5-00704715-eed3-4694-a041-69d721b70306_52b025c1-275a-4b9d-919c-16031081d133.html,,,,,, "Fatty acids, tallow, calcium salts",64755-01-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2033cf85-80fd-4e21-9083-fda849a033b9/documents/IUC5-00704715-eed3-4694-a041-69d721b70306_52b025c1-275a-4b9d-919c-16031081d133.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,089.75 mg/kg bw/day",,rat "Fatty acids, tallow, calcium salts",64755-01-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2033cf85-80fd-4e21-9083-fda849a033b9/documents/IUC5-00704715-eed3-4694-a041-69d721b70306_52b025c1-275a-4b9d-919c-16031081d133.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,500 mg/kg bw/day",,rat "Fatty acids, tallow, calcium salts",64755-01-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2033cf85-80fd-4e21-9083-fda849a033b9/documents/IUC5-00704715-eed3-4694-a041-69d721b70306_52b025c1-275a-4b9d-919c-16031081d133.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.86 mg/cm2,adverse effect observed,rat "Fatty acids, tallow, calcium salts",64755-01-7,It is considered from the results that all the substances in the category of calcium salts of C14-C22 monocarboxylic acids exhibit a similar lack of acute oral and dermal toxicity potential across the entire category. There is no evidence of a relevant intrinsic acute oral or dermal toxicity requiring classification or substance specific RMMs. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2033cf85-80fd-4e21-9083-fda849a033b9/documents/IUC5-64c918c7-4259-4201-9aed-871240fa0275_52b025c1-275a-4b9d-919c-16031081d133.html,,,,,, "Fatty acids, tallow, calcium salts",64755-01-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2033cf85-80fd-4e21-9083-fda849a033b9/documents/IUC5-64c918c7-4259-4201-9aed-871240fa0275_52b025c1-275a-4b9d-919c-16031081d133.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tallow, calcium salts",64755-01-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2033cf85-80fd-4e21-9083-fda849a033b9/documents/IUC5-64c918c7-4259-4201-9aed-871240fa0275_52b025c1-275a-4b9d-919c-16031081d133.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tallow, compds. with triethanolamine",61790-67-8," Repeated dose toxicty: Oral Route Under the conditions of the study, the No Observed Adverse Effect Level (NOAEL) was considered to be 1000 mg/kg/day. Repeated dose toxicity: Inhalation Route In accordance with Section 8.6.1. of Column 2 of Annex VIII of the REACH Regulation, Short-term repeated dose toxicity study (28 days) should be conducted on one species, male and female, through the most appropriate route of administration, having regard to the likely route of human exposure which in this case is the oral route. Repeated dose toxicity: Dermal Route In accordance with Section 8.6.1. of Column 2 of Annex VIII of the REACH Regulation, Short-term repeated dose toxicity study (28 days) should be conducted on one species, male and female, through the most appropriate route of administration, having regard to the likely route of human exposure which in this case is the oral route. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db795337-62be-4bb8-90f0-1371702324f3/documents/cc53ff67-0954-4677-a89b-2f2cb937e81f_a810f8d8-f941-4285-8fef-cc49114139b7.html,,,,,, "Fatty acids, tallow, compds. with triethanolamine",61790-67-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db795337-62be-4bb8-90f0-1371702324f3/documents/cc53ff67-0954-4677-a89b-2f2cb937e81f_a810f8d8-f941-4285-8fef-cc49114139b7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, tallow, compds. with triethanolamine",61790-67-8," Acute oral toxicity The LD50 of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight and as such requires no classification in accordance with EU criteria. Acute Inhalation Toxicity In accordance with Section 8.5.2. of Column 2 of Annex VIII of the REACH Regulation, the registrant proposes to waive the acute toxicity testing by the inhalation route on the basis that exposure to humans via inhalation is unlikely, taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. Acute Dermal Toxicity In accordance with Section 8.5.3. of Column 2 of Annex VIII of the REACH Regulation, the registrant proposes to waive the acute toxicity testing by the dermal route on the basis that the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been seen in in vivo studies with dermal exposure (skin sensitisation). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db795337-62be-4bb8-90f0-1371702324f3/documents/e6eb8f42-73e1-4f0b-9d44-f299972bc4b9_a810f8d8-f941-4285-8fef-cc49114139b7.html,,,,,, "Fatty acids, tallow, compds. with triethanolamine",61790-67-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db795337-62be-4bb8-90f0-1371702324f3/documents/e6eb8f42-73e1-4f0b-9d44-f299972bc4b9_a810f8d8-f941-4285-8fef-cc49114139b7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, tallow, zinc salts",68440-34-6,"Hazard assessment is conducted by means of read-across from surrogates.Oral: NOAEL (OECD 408, rat): 13.3 mg Zn/kg bw/day (RA from CAS 7440-66-6)NOAEL (OECD 408, rat): 53.5 mg Zn/kg bw/day (RA from CAS 7733-02-0)NOAEL (OECD 408, mouse): 104 mg Zn/kg bw/day (RA from CAS 7733-02-0)InhalationNOAEL (guinea pig, 5d): 2.2 mg Zn/m³ (RA from CAS 1314-13-2, ultra fine)Human data: The oral NOAEL of 0.83 mg Zn/kg bw/day (recalculated from the NOAEL of 50 mg Zn/day for a 60 kg human being) was used as the starting point for deriving DNELs for worker and general population. NOAELs for zinc exposure via the dermal or inhalatory route were estimated by taking into account the bioavailability of zinc via the different exposure routes (for details see the Chemical Safety Assessment of ""Zinc"" within the framework of Regulation (EC) No 1907/2006 in the technical Dossier (see IUCLID section 13)). By molecular weight correction, these data are read across to Fatty acids, tallow, zinc salts. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1722ce2-534a-48f5-9cfa-6c47791bb5f5/documents/IUC5-3bfcc689-2e92-4f97-97cc-1a8920c73cef_7e1adff7-c9c3-4c9d-994b-b2ed55fec7e9.html,,,,,, "Fatty acids, tallow, zinc salts",68440-34-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1722ce2-534a-48f5-9cfa-6c47791bb5f5/documents/IUC5-3bfcc689-2e92-4f97-97cc-1a8920c73cef_7e1adff7-c9c3-4c9d-994b-b2ed55fec7e9.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,22 mg/m3,,guinea pig "Fatty acids, tallow, zinc salts",68440-34-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1722ce2-534a-48f5-9cfa-6c47791bb5f5/documents/IUC5-3bfcc689-2e92-4f97-97cc-1a8920c73cef_7e1adff7-c9c3-4c9d-994b-b2ed55fec7e9.html,Chronic toxicity – systemic effects,oral,NOAEL,8.3 mg/kg bw/day,,other:human "Fatty acids, tallow, zinc salts",68440-34-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1722ce2-534a-48f5-9cfa-6c47791bb5f5/documents/IUC5-3bfcc689-2e92-4f97-97cc-1a8920c73cef_7e1adff7-c9c3-4c9d-994b-b2ed55fec7e9.html,Repeated dose toxicity – local effects,inhalation,NOAEC,22 mg/m3,adverse effect observed,guinea pig "Fatty acids, tallow, zinc salts",68440-34-6,"Hazard assessment is conducted by means of read-across from structural analogues.The slightly soluble and insoluble zinc compounds (i.e., zinc oxide, zinc hydroxide, zinc phosphate, zinc carbonate, zinc metal, zinc sulphide as well as Fatty acids, C16-18, zinc salts ) are of low acute, dermal and inhalation toxicity not requiring a classification for acute toxicity according to the EC criteria. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1722ce2-534a-48f5-9cfa-6c47791bb5f5/documents/IUC5-b641376b-d222-46a3-85cf-4ac88ecd1cde_7e1adff7-c9c3-4c9d-994b-b2ed55fec7e9.html,,,,,, "Fatty acids, vegetable-oil, esters with dipropylene glycol",95009-41-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study (Klimisch score 2 due to read-across) from a reference substance with similar structure and intrinsic properties. Read-across is justified based on common functional group(s) and similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details). The selected study is thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.6, in accordance with AnnexXI, 1.5, of Regulation (EC) No 1907/2006. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3469a9a7-26b6-439a-9463-6b55dd676e4e/documents/IUC5-38eadfe3-e740-4443-990f-b82ffaaef4a8_5acd2a2f-57d4-49ad-a4d3-28ff4ab3c794.html,,,,,, "Fatty acids, vegetable-oil, esters with dipropylene glycol",95009-41-9,"Acute toxicity:Oral (OECD 420), rat: LD50 > 2000 mg/kg bwInhalation (OECD 403), rat: LC50 > 2.916 mg/L airDermal (OECD 402), rat: LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3469a9a7-26b6-439a-9463-6b55dd676e4e/documents/IUC5-7e49db64-e02d-4d7a-8ba7-e5cb2b8d9f20_5acd2a2f-57d4-49ad-a4d3-28ff4ab3c794.html,,,,,, "Fatty acids, vegetable-oil, Me esters",68990-52-3, NOAEL subcronic toxicity rat = 1000 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6293606c-0a14-4612-8968-d166f9e882c1/documents/IUC5-9067717e-9ac2-438c-b77f-48e2248df0ff_28f4536d-4787-4e26-96bc-96bace376670.html,,,,,, "Fatty acids, vegetable-oil, Me esters",68990-52-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6293606c-0a14-4612-8968-d166f9e882c1/documents/IUC5-9067717e-9ac2-438c-b77f-48e2248df0ff_28f4536d-4787-4e26-96bc-96bace376670.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Fatty acids, vegetable-oil, Me esters",68990-52-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6293606c-0a14-4612-8968-d166f9e882c1/documents/IUC5-02307e87-e508-40ec-a678-45fd8dccd77c_28f4536d-4787-4e26-96bc-96bace376670.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Fatty acids, vegetable-oil, Me esters",68990-52-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6293606c-0a14-4612-8968-d166f9e882c1/documents/IUC5-02307e87-e508-40ec-a678-45fd8dccd77c_28f4536d-4787-4e26-96bc-96bace376670.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, vegetable-oil, Me esters, sulfurized",72102-30-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/413dbe6f-645d-49a4-9781-6c399e768dbe/documents/8c887678-6933-463d-9ad0-420fbbbdc759_d6a5db95-3943-4310-8629-0b3eb3c17102.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, vegetable-oil, Me esters, sulfurized",72102-30-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/413dbe6f-645d-49a4-9781-6c399e768dbe/documents/8c887678-6933-463d-9ad0-420fbbbdc759_d6a5db95-3943-4310-8629-0b3eb3c17102.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, vegetable-oil, sulfated, sodium salts",61788-67-8,"Oils, fish, sulfated sodium salt: NOAEL rat (90 d) = 1000 mg/kg bw/day   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/580fb48c-76a5-413f-b5c2-acf4ecb643f0/documents/IUC5-50618ff2-7558-4db1-8090-0e5a7868f85f_a3a6444c-e0ec-4fd0-a3ef-047737efc709.html,,,,,, "Fatty acids, vegetable-oil, sulfated, sodium salts",61788-67-8,"Oils fish sulphated sodium salt oral > 2000 mg/kg Oils rape sulphated sodium salt oral and dermal> 2000 mg/kg FLL sample 4, limit test, LD50 dermal> 2000 mg/kg FLL sample 3, LD50 dermal > 2000 mg/kg Acute toxicity inhalation: not relevant     ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/580fb48c-76a5-413f-b5c2-acf4ecb643f0/documents/IUC5-a36fa659-08c9-4e56-ae0b-92c3b2538708_a3a6444c-e0ec-4fd0-a3ef-047737efc709.html,,,,,, "Fatty acids, vegetable-oil, sulfated, sodium salts",61788-67-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/580fb48c-76a5-413f-b5c2-acf4ecb643f0/documents/IUC5-a36fa659-08c9-4e56-ae0b-92c3b2538708_a3a6444c-e0ec-4fd0-a3ef-047737efc709.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, vegetable-oil, sulfated, sodium salts",61788-67-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/580fb48c-76a5-413f-b5c2-acf4ecb643f0/documents/IUC5-a36fa659-08c9-4e56-ae0b-92c3b2538708_a3a6444c-e0ec-4fd0-a3ef-047737efc709.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Fenamiphos,22224-92-6,"Endpoints for repeated dose toxicity are covered by available animal studies.   The test substance was shown to result in adverse effects in repeated dose toxicity studies: erythrocyte ChE inhibition.   The NOAEL for repeated dose toxicity was 0.083 mg/kg bw/day in a 1-year feeding study in dogs and 0.06 mg/kg bw/d in a 2-year feeding study in dogs. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a62760f-5bd0-47f4-b434-3f9f8e1e2b5b/documents/87c3c085-bde2-4a8d-bd02-000d17fb26d8_93426e52-b69c-4f12-bd0c-9db0fbe2cc59.html,,,,,, Fenamiphos,22224-92-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a62760f-5bd0-47f4-b434-3f9f8e1e2b5b/documents/87c3c085-bde2-4a8d-bd02-000d17fb26d8_93426e52-b69c-4f12-bd0c-9db0fbe2cc59.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,2.5 mg/kg bw/day,,rat Fenamiphos,22224-92-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a62760f-5bd0-47f4-b434-3f9f8e1e2b5b/documents/87c3c085-bde2-4a8d-bd02-000d17fb26d8_93426e52-b69c-4f12-bd0c-9db0fbe2cc59.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,3.5 mg/m3,,rat Fenamiphos,22224-92-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a62760f-5bd0-47f4-b434-3f9f8e1e2b5b/documents/87c3c085-bde2-4a8d-bd02-000d17fb26d8_93426e52-b69c-4f12-bd0c-9db0fbe2cc59.html,Chronic toxicity – systemic effects,oral,NOAEL,0.083 mg/kg bw/day,,rat Fenamiphos,22224-92-6,"Endpoints for acute toxicity are covered by available animal studies. The test substance is acutely toxic to rats following administration by the oral, dermal and inhalation route.   Oral The oral LD50 in rats was 6.0 – 6.1 mg/kg bw in males and females.   Dermal The dermal LD50 in rats was 72 – 92 mg/kg bw in males and females.   Inhalation The LC50 inhalation of the test item in rats was 65 – 79 mg/m3 for 4 h (aerosol) exposure in males and females.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch 1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a62760f-5bd0-47f4-b434-3f9f8e1e2b5b/documents/c5bac540-7d8d-42f9-9903-504f48df777b_93426e52-b69c-4f12-bd0c-9db0fbe2cc59.html,,,,,, Fenamiphos,22224-92-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a62760f-5bd0-47f4-b434-3f9f8e1e2b5b/documents/c5bac540-7d8d-42f9-9903-504f48df777b_93426e52-b69c-4f12-bd0c-9db0fbe2cc59.html,,oral,LD50,6 mg/kg bw,adverse effect observed, Fenamiphos,22224-92-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a62760f-5bd0-47f4-b434-3f9f8e1e2b5b/documents/c5bac540-7d8d-42f9-9903-504f48df777b_93426e52-b69c-4f12-bd0c-9db0fbe2cc59.html,,dermal,LD50,72 mg/kg bw,adverse effect observed, Fenamiphos,22224-92-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a62760f-5bd0-47f4-b434-3f9f8e1e2b5b/documents/c5bac540-7d8d-42f9-9903-504f48df777b_93426e52-b69c-4f12-bd0c-9db0fbe2cc59.html,,inhalation,LC50,65 mg/m3,adverse effect observed, Fenitrothion,122-14-5, A 28 -day study is not available; however a 90 -day oral rat toxicity study is available for fenitrothion and is supported by a further (non-standard) 90 -day study of ocular toxicity. A 21 -day repeated dose dermal toxicity in the rabbit is also available for fenitrothion. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93d9567f-0b5a-4788-a43f-a64d84eee0ba/documents/9ba193b8-a03e-4385-9253-8659465ebd9b_1e6ac065-2130-4be1-93d9-797181cda857.html,,,,,, Fenitrothion,122-14-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93d9567f-0b5a-4788-a43f-a64d84eee0ba/documents/9ba193b8-a03e-4385-9253-8659465ebd9b_1e6ac065-2130-4be1-93d9-797181cda857.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,3 mg/kg bw/day,,rabbit Fenitrothion,122-14-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93d9567f-0b5a-4788-a43f-a64d84eee0ba/documents/9ba193b8-a03e-4385-9253-8659465ebd9b_1e6ac065-2130-4be1-93d9-797181cda857.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,1.32 mg/kg bw/day,,rat Fenitrothion,122-14-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93d9567f-0b5a-4788-a43f-a64d84eee0ba/documents/9ba193b8-a03e-4385-9253-8659465ebd9b_1e6ac065-2130-4be1-93d9-797181cda857.html,Repeated dose toxicity – local effects,dermal,LOAEL,3 mg/cm2,adverse effect observed,rabbit Fenitrothion,122-14-5," Studies of acute oral, inhalation and dermal toxicity are available for fenitrothion. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93d9567f-0b5a-4788-a43f-a64d84eee0ba/documents/27220d51-5331-46e7-b6c2-1f3fc89bab4b_1e6ac065-2130-4be1-93d9-797181cda857.html,,,,,, Fenitrothion,122-14-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93d9567f-0b5a-4788-a43f-a64d84eee0ba/documents/27220d51-5331-46e7-b6c2-1f3fc89bab4b_1e6ac065-2130-4be1-93d9-797181cda857.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Fenitrothion,122-14-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93d9567f-0b5a-4788-a43f-a64d84eee0ba/documents/27220d51-5331-46e7-b6c2-1f3fc89bab4b_1e6ac065-2130-4be1-93d9-797181cda857.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Fenitrothion,122-14-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93d9567f-0b5a-4788-a43f-a64d84eee0ba/documents/27220d51-5331-46e7-b6c2-1f3fc89bab4b_1e6ac065-2130-4be1-93d9-797181cda857.html,,inhalation,LC50,"2,210 mg/m3",no adverse effect observed, Fenuron,101-42-8," Oral toxicity data were available for Fenuron. A subacute toxicity test was waived due to presence of an appropriate subchronic toxicity study in rats dosed for 90 days by oral gavage at doses of 20,100 and 500 mg/kg bw/d. At 500 mg/kg bw, slight reduction in body weight gain was observed in both sexes. Clinical-chemical findings were seen at 100 and 500 mg/kg bw/d (increased serum alkaline phosphatase, alanine aminotransferase, leucine aminopeptidase and cholesterol; decreased serum cholinesterase and glucose). Increased absolute and relative liver weights were observed at 100 and 500 mg/kg bw/d and decreased thymus weight was observed at 500 mg/kg bw/d. No histopathological findings were observed in any organs at the various doses. For Fenuron, a NOEL of 20 mg/kg bw was determined under the given experimental conditions. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83c82f21-d4f3-486a-b0de-550405736797/documents/41a69c1c-fbda-443a-8b13-fa9d13a7f3cf_85c95ce1-dadb-433e-b756-1ffebf21c759.html,,,,,, Fenuron,101-42-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83c82f21-d4f3-486a-b0de-550405736797/documents/41a69c1c-fbda-443a-8b13-fa9d13a7f3cf_85c95ce1-dadb-433e-b756-1ffebf21c759.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat Fenuron,101-42-8," Various consistent weight-of-evidence and supporting literature data are available for oral acute toxicity in rats, mice, guinea pigs and rabbits. The lowest oral LD50of Fenuron was 3200 mg/kg in guinea pigs. Central nervous system changes, functional disorders of the hematopoietic system and the adrenal cortex were observed. A key inhalation acute toxicity study with Fenuron (mass median aerodynamic diameter = 1.595 µm) in rats resulted in a LC50 value > 5.06 mg /L air/4 hours (nose-only). Clinical observations revealed slight dyspnea immediately until 3 hours after end of exposure. A dermal acute toxicity study was waived because inhalation of the substance is likely and oral acute toxicity data are available, therefore the study is scientifically not necessary. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83c82f21-d4f3-486a-b0de-550405736797/documents/a4d78910-52c4-4714-b09c-7ca047b1f78f_85c95ce1-dadb-433e-b756-1ffebf21c759.html,,,,,, Fenuron,101-42-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83c82f21-d4f3-486a-b0de-550405736797/documents/a4d78910-52c4-4714-b09c-7ca047b1f78f_85c95ce1-dadb-433e-b756-1ffebf21c759.html,,oral,LD50,"3,200 mg/kg bw",no adverse effect observed, Fenuron,101-42-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83c82f21-d4f3-486a-b0de-550405736797/documents/a4d78910-52c4-4714-b09c-7ca047b1f78f_85c95ce1-dadb-433e-b756-1ffebf21c759.html,,inhalation,LC50,"5,060 mg/m3",no adverse effect observed, "sodium [2,2'-(ethane-1,2-diylbis{[2-(hydroxy-kO)benzyl]imino-kN})diacetato-kO(4-)]ferrat(1-)",1061328-86-6,"In a 90-day oral (gavage) key repeated dose toxicity study in rats (Novartis, 1998) conducted with the nearest analogue Fe(Na)EDDHA, the NOAEL was established at 10 mg/kg bw/day based on a transient normochromic anaemia present at higher dose levels (estimated from LOAEL). Changes in clinical laboratory parameters noted at higher dose levels and indicative of effects on kidneys and/or liver were without microscopic correlate under the conditions of this study. A supporting and preceding dose range finding subacute oral (gavage) toxicity study (CIBA-GEIGY Limited, 1996a) conducted with this nearest analogue in rats provided further indication that the haematopoietic system and, at higher dose levels, the kidney represented target organs following repeated oral exposure. In a key subacute 28-day dermal toxicity study (CIBA-GEIGY Limited, 1996b), the NOEL was established at 100 mg/kg bw/day based on slight effects on the liver and skin and due to increased adrenal weight noted at the high dose level of 1000 mg/kg bw/day. No data on repeated inhalation exposure are required. Exposure by the inhalation route is considered to be negligible. The target substance Fe(Na)HBED does not need to be classified for systemic organ toxicity after repeated exposures. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6dee3ce-9487-4ab8-a46a-16b637df5d65/documents/IUC5-c2ba4106-23f4-484f-b784-a772990b88d9_c0a0fdfa-5d97-48ed-a68c-c2ca438fe709.html,,,,,, "sodium [2,2'-(ethane-1,2-diylbis{[2-(hydroxy-kO)benzyl]imino-kN})diacetato-kO(4-)]ferrat(1-)",1061328-86-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6dee3ce-9487-4ab8-a46a-16b637df5d65/documents/IUC5-c2ba4106-23f4-484f-b784-a772990b88d9_c0a0fdfa-5d97-48ed-a68c-c2ca438fe709.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,,rat "sodium [2,2'-(ethane-1,2-diylbis{[2-(hydroxy-kO)benzyl]imino-kN})diacetato-kO(4-)]ferrat(1-)",1061328-86-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6dee3ce-9487-4ab8-a46a-16b637df5d65/documents/IUC5-c2ba4106-23f4-484f-b784-a772990b88d9_c0a0fdfa-5d97-48ed-a68c-c2ca438fe709.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "sodium [2,2'-(ethane-1,2-diylbis{[2-(hydroxy-kO)benzyl]imino-kN})diacetato-kO(4-)]ferrat(1-)",1061328-86-6,The LD50 of greater than 2000 mg/kg bw were established in the acute oral and in the acute dermal toxicity studies. No treatment related effects were observed in the animals during the course of these studies. The substance Fe (Na)HBED is considered to be not acutely toxic by all routes of exposure and does not need to be classified and labelled according to CLP. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6dee3ce-9487-4ab8-a46a-16b637df5d65/documents/IUC5-e96fd676-23a7-4e8b-bedc-9022a6f5967f_c0a0fdfa-5d97-48ed-a68c-c2ca438fe709.html,,,,,, "sodium [2,2'-(ethane-1,2-diylbis{[2-(hydroxy-kO)benzyl]imino-kN})diacetato-kO(4-)]ferrat(1-)",1061328-86-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6dee3ce-9487-4ab8-a46a-16b637df5d65/documents/IUC5-e96fd676-23a7-4e8b-bedc-9022a6f5967f_c0a0fdfa-5d97-48ed-a68c-c2ca438fe709.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "sodium [2,2'-(ethane-1,2-diylbis{[2-(hydroxy-kO)benzyl]imino-kN})diacetato-kO(4-)]ferrat(1-)",1061328-86-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6dee3ce-9487-4ab8-a46a-16b637df5d65/documents/IUC5-e96fd676-23a7-4e8b-bedc-9022a6f5967f_c0a0fdfa-5d97-48ed-a68c-c2ca438fe709.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate;iron(2+),15651-72-6,NOAEL is ≥ 84 mg/kg bw/day for rats after 31/61 days of exposure via the food with the analogous substance FeNaEDTA (CAS 15708-41-5). This corresponds to a dose of 74 mg EDTAFeHNa/ kg bw/d. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55d5e0d0-8103-45cc-9e4f-6cae741dc078/documents/IUC5-1c869f71-31f6-4680-a36a-0adbbf33a416_e846cd5b-0448-409f-a1b4-1b2124e487b8.html,,,,,, 2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate;iron(2+),15651-72-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55d5e0d0-8103-45cc-9e4f-6cae741dc078/documents/IUC5-1c869f71-31f6-4680-a36a-0adbbf33a416_e846cd5b-0448-409f-a1b4-1b2124e487b8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,74 mg/kg bw/day,,rat 2-[2-[bis(carboxylatomethyl)amino]ethyl-(carboxylatomethyl)amino]acetate;iron(2+),15651-72-6,"By analogy with FeNaEDTA (CAS 15708-41-5):- LD50 oral, rat > 2000 mg/kg bw- LD50 dermal, rat > 2000 mg/kg bw- LC50 inhalation, rat > 2.75 +/- 0.19 mg/L air ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55d5e0d0-8103-45cc-9e4f-6cae741dc078/documents/IUC5-2eb41951-de5b-4985-856e-2a6ef6e32529_e846cd5b-0448-409f-a1b4-1b2124e487b8.html,,,,,, "Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts",12237-63-7,"Repeated Dose Oral Toxicity: Based on the presented data, the target chemical is expected not to be toxic to rats and mice following repeated dose exposure.   Repeated Dose Inhalation Toxicity A short-term toxicity study need not be conducted as because exposure of humans via inhalation route in production and/or use is not likely based on the provided thorough and rigorous exposure assessment. The estimated vapor pressure of the test chemical was 3.49E-10 mm Hg.Hence, this endpoint can be considered for waiver   Repeated Dose dermal Toxicity A short-term toxicity study need not be conducted as because exposure of humans via dermal route in production and/or use is not likely based on the provided thorough and rigorous exposure assessment.The acute dermal LD50 of the test chemical can be considered to be >2000 mg/kgbw. Hence, this endpoint was considered for waiver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c870da47-e173-4f14-947b-43266f48e76b/documents/d4ab8bed-ea5b-49d6-afec-661bfe597b0c_6d68d73a-f037-4577-b97c-6818e2b20536.html,,,,,, "Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts",12237-63-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c870da47-e173-4f14-947b-43266f48e76b/documents/d4ab8bed-ea5b-49d6-afec-661bfe597b0c_6d68d73a-f037-4577-b97c-6818e2b20536.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts",12237-63-7,"Acute oral toxicity: An acute oral toxicity dose (LD50) for target chemical was considered based on different experimental studies conducted on rats. The LD50 values were considered to be >5000 mg/kg bw; 3755 mg/kg bw, with 95% confidence limit of 2715-5193 mg/kg bw; and >3200 mg/kg bw. Thus, comparing these values with the criteria of CLP regulation, test chemical cannot be classified for acute oral toxicity.   Acute Inhalation toxicity: An acute inhalation toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the given test chemical has very low vapor pressure 1.15E-10 Pa at 25°C., so the potential for the generation of inhalable vapors is very low. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated inhalation toxicity was considered for waiver.   Acute Dermal toxicity: The acute dermal toxicity dose (LD50) for target chemical was considered based on experimental study conducted on rats, the value was considered to be >2500 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c870da47-e173-4f14-947b-43266f48e76b/documents/0020ae55-603b-482b-8ebb-2b41c52f3727_6d68d73a-f037-4577-b97c-6818e2b20536.html,,,,,, "Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts",12237-63-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c870da47-e173-4f14-947b-43266f48e76b/documents/0020ae55-603b-482b-8ebb-2b41c52f3727_6d68d73a-f037-4577-b97c-6818e2b20536.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Ferrate(4-), hexakis(cyano-C)-, Et 2-[6-(ethylamino)-3-(ethylimino)-2,7-dimethyl-3H-xanthen-9-yl]benzoate copper(2+) salts",12237-63-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c870da47-e173-4f14-947b-43266f48e76b/documents/0020ae55-603b-482b-8ebb-2b41c52f3727_6d68d73a-f037-4577-b97c-6818e2b20536.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, "Ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts",12237-62-6,"Repeated Dose Oral Toxicity: Based on the available results and applying the weight of evidence approach, the test chemical can be considered to be non-toxic to living organisms when dosed repeatedly via oral route. The No Observed Adverse Effect Level can be considered to be 500mg/kgbw/day. Comparing the above annotations with the criteria of CLP Regulation, the test chemical can be classified under the category “Not Classified”.   Repeated Dose Inhalation Toxicity A short-term toxicity study need not be conducted as because exposure of humans via inhalation route in production and/or use is not likely based on the provided thorough and rigorous exposure assessment. The estimated vapor pressure of the test chemical was 3.49E-10 mm Hg.Hence, this endpoint can be considered for waiver   Repeated Dose dermal Toxicity A short-term toxicity study need not be conducted as because exposure of humans via dermal route in production and/or use is not likely based on the provided thorough and rigorous exposure assessment.The acute dermal LD50 of the test chemical can be considered to be >2000 mg/kgbw. Hence, this endpoint was considered for waiver.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1994fc8d-d95d-440f-8ac2-c0edd9c01e63/documents/44535423-f521-4182-b524-8de844059121_0fba7176-02b0-4e28-854f-7b29385a08d1.html,,,,,, "Ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts",12237-62-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1994fc8d-d95d-440f-8ac2-c0edd9c01e63/documents/44535423-f521-4182-b524-8de844059121_0fba7176-02b0-4e28-854f-7b29385a08d1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts",12237-62-6,"Acute oral toxicity:  The acute oral toxicity dose (LD50) for test chemical was considered based on experimental study, the value considered to be >6000 mg/kg bw in rat. This study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute oral toxicity.   Acute Inhalation toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the vapour pressure of the test chemical. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely.The estimated vapor pressure of the test chemical was 3.49E-10 mm Hg.Hence, this endpoint can be considered for waiver .   Acute Dermal toxicity: The acute dermal toxicity dose (LD50) for test chemical was considered based on experimental study, the value considered to be >2000 mg/kg bw in rat. Thus, comparing this value with the criteria of CLP regulation, test chemical cannot be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1994fc8d-d95d-440f-8ac2-c0edd9c01e63/documents/e23bff30-bb84-42c8-b1c9-1abe04c11920_0fba7176-02b0-4e28-854f-7b29385a08d1.html,,,,,, "Ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts",12237-62-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1994fc8d-d95d-440f-8ac2-c0edd9c01e63/documents/e23bff30-bb84-42c8-b1c9-1abe04c11920_0fba7176-02b0-4e28-854f-7b29385a08d1.html,,oral,LD50,"6,000 mg/kg bw",no adverse effect observed, "Ferrate(4-), hexakis(cyano-C)-, methylated 4-[(4-aminophenyl)(4-imino-2,5-cyclohexadien-1-ylidene)methyl]benzenamine copper(2+) salts",12237-62-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1994fc8d-d95d-440f-8ac2-c0edd9c01e63/documents/e23bff30-bb84-42c8-b1c9-1abe04c11920_0fba7176-02b0-4e28-854f-7b29385a08d1.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Ferrocene,102-54-5," Four good quality studies provide the endpoint data for repeated dose toxicity. A chronic (180d) oral study produced a LOAEL of 30 mg/kg (Yeary, 1969). In support a 28 day study produced a NOAEL of 5 mg/kg (Innospec, 1998). A 90 day sub chronic inhalation study produced a LOAEC of 3 mg/ m3 (Nikula, 1993). In support a 14 day study obtained a NOAEC of 5.0 mg/m3 (Sun et al, 1991). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85411388-7725-4eab-8b20-f1cdfe371e22/documents/IUC5-445894e7-21e4-4f3e-8d09-eee5e35f6f06_7e7ed760-fdd2-4862-9e11-f3ad1522679d.html,,,,,, Ferrocene,102-54-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85411388-7725-4eab-8b20-f1cdfe371e22/documents/IUC5-445894e7-21e4-4f3e-8d09-eee5e35f6f06_7e7ed760-fdd2-4862-9e11-f3ad1522679d.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,3 mg/m3,,other:rat and mouse Ferrocene,102-54-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85411388-7725-4eab-8b20-f1cdfe371e22/documents/IUC5-445894e7-21e4-4f3e-8d09-eee5e35f6f06_7e7ed760-fdd2-4862-9e11-f3ad1522679d.html,Chronic toxicity – systemic effects,oral,LOAEL,30 mg/kg bw/day,,dog Ferrocene,102-54-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85411388-7725-4eab-8b20-f1cdfe371e22/documents/IUC5-445894e7-21e4-4f3e-8d09-eee5e35f6f06_7e7ed760-fdd2-4862-9e11-f3ad1522679d.html,Repeated dose toxicity – local effects,inhalation,LOAEC,3 mg/m3,adverse effect observed,other:rat and mouse Ferrocene,102-54-5," In a peer reviewed study performed to OECD Guideline 401, ferrocene has an oral LD50 1320mg/kg bw (Bingham, 2001). In a study performed to OECD Guideline 402, ferrocene has a dermal LD50 >3000mg/kg bw (Innospec 1987). Acute Inhalation studies have been waived based on existing data, exposure considerations and animal welfare. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85411388-7725-4eab-8b20-f1cdfe371e22/documents/IUC5-4eb9011b-3bbd-4ab7-af15-5a3e3148b827_7e7ed760-fdd2-4862-9e11-f3ad1522679d.html,,,,,, Ferrocene,102-54-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85411388-7725-4eab-8b20-f1cdfe371e22/documents/IUC5-4eb9011b-3bbd-4ab7-af15-5a3e3148b827_7e7ed760-fdd2-4862-9e11-f3ad1522679d.html,,oral,LD50,"1,320 mg/kg bw",adverse effect observed, Ferrocene,102-54-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85411388-7725-4eab-8b20-f1cdfe371e22/documents/IUC5-4eb9011b-3bbd-4ab7-af15-5a3e3148b827_7e7ed760-fdd2-4862-9e11-f3ad1522679d.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, "ferrocene, (4-chlorobutyl)-",141719-29-1," Acute toxicity, oral in rats: LD50 = 1211 mg/kg bw (OECD 401, GLP, K, Rel. 1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/356b69df-53c5-4617-b465-0c6cb324c18a/documents/ad2b3a6d-3623-4d4c-bcd4-74e1bdbba682_82afbc7b-d99c-4747-a854-1837d3728fa4.html,,,,,, "ferrocene, (4-chlorobutyl)-",141719-29-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/356b69df-53c5-4617-b465-0c6cb324c18a/documents/ad2b3a6d-3623-4d4c-bcd4-74e1bdbba682_82afbc7b-d99c-4747-a854-1837d3728fa4.html,,oral,LD50,"1,211 mg/kg bw",adverse effect observed, "ferrocene, [4-(dimethylsilyl)butyl]-",102744-79-6," Acute toxicity, oral in rats: LD50 = 1506 mg/kg bw (OECD 401, GLP, K, Rel. 1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa1ab101-30af-4179-b333-9066d0c5b497/documents/d9752631-d865-4123-bb0f-d37386ee2a1d_49608b2a-afd9-44b1-ad59-37c726e2bd82.html,,,,,, "ferrocene, [4-(dimethylsilyl)butyl]-",102744-79-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa1ab101-30af-4179-b333-9066d0c5b497/documents/d9752631-d865-4123-bb0f-d37386ee2a1d_49608b2a-afd9-44b1-ad59-37c726e2bd82.html,,oral,LD50,"1,211 mg/kg bw",adverse effect observed, Ferrocholinate,1336-80-7," LD50 (oral, mouse): 5500 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4916ec21-584e-4146-afc2-46bd65c83ab3/documents/1a6d3e59-f045-41e2-9eae-7466f8fe18d1_d00c05b0-7931-40c1-ba69-e8c515022b1f.html,,,,,, Ferrocholinate,1336-80-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4916ec21-584e-4146-afc2-46bd65c83ab3/documents/1a6d3e59-f045-41e2-9eae-7466f8fe18d1_d00c05b0-7931-40c1-ba69-e8c515022b1f.html,,oral,LD50,"5,500 mg/kg bw",no adverse effect observed, "fipronil (ISO); (±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinyl-pyrazole-3-carbonitrile",120068-37-3,"Oral short-term toxicity studies with the test substance comprised of rat and dog 28-day, rat and dog 90-day and two dog 1-year toxicity tests. In addition, a rabbit 21-day dermal toxicity study was performed. All studies were carried out between March 1989 and January 1993. They adhered to prevailing international testing guidelines, except for the dog 28-day study for which no guidelines are available. Short term oral studies in rats In the 28-day study, one female rat given the highest dose level, 400 ppm, died in Week 1.  Its death may or may not have been treatment-related.  A transient dose-related loss of bodyweight occurred on Day 5 at 100, 200 and 400 ppm which was considered to be due to an initial reduction in food consumption.  Thyroid follicular cell hypertrophy was seen in all treated groups and hepatocyte hypertrophy in the liver was found at 100 ppm and above, apart from in females where there were no hepatic changes at 100 ppm.  These findings were associated with increases in bodyweight-relative liver weight at 100 ppm and above and marginally higher bodyweight-relative thyroid weights in all groups of treated females.  Clinical chemistry findings were increased total protein and globulin in all treated groups, although there was no dose-related response, high cholesterol in both sexes at 400 ppm and in females fed 25 and 200 ppm, and decreased albumin in females at 400 ppm.  The only hematological finding was an increase in platelets at 200 and 400 ppm. Based on histopathological findings in the liver and thyroid, a No Observed Effect Level (NOEL) was not identified in this study i.e. NOEL < 25 ppm which corresponded to 3.4 mg/kg bw/d in males and 3.5 mg/kg bw/d in females. Dose levels of 0, 1, 5, 30 and 300 ppm were used in the 90-day rat study.  A single incident of clonic convulsion in one high dose level male was noted in Week 9.  At the highest dose level, a transient reduction in food intake and body weight gain was seen during the first week of treatment.  Male body weight gain at this dose level was still reduced during Week 2.  A dose-related increase in liver weight at 5 ppm and above, together with changes in plasma aminotransferase activity, protein, urea and glucose in treated rats, was considered indicative of altered liver function.  At dose levels of up to 5 ppm, plasma changes were generally minor and not associated with any histopathological change.  Therefore, they were considered to be adaptive metabolic responses to the administration of a xenobiotic and not likely to be of direct toxicological significance.  At 300 ppm, a degree of toxicity was induced, manifest as increased in fat deposition in males. A minor disturbance of red cell parameters was noted in females from this dose level. Thyroid follicular hypertrophy and thyroid hyperplasia was also seen at 300 ppm and was probably indicative of a perturbation of the hypothalamo-pituitary-thyroid-liver axis resulting from the increased metabolic activity of the liver. The study report also concluded that the tendency for increases in liver and thyroid weights and changes in serum protein levels observed at 30 ppm were not toxicologically relevant in the absence of histopathological changes. However, given the observations of mild thyroid changes at 25 ppm in the 28-day oral toxicity study in rats the dose level of 30 ppm is considered to represent a Low Observed Adverse Effect Level (LOAEL) in this study.  The No Observed Adverse Effect Level (NOAEL) was established at 5 ppm, which corresponded to 0.33 and 0.37 mg/kg bw/d in male and female rats, respectively. Short term oral studies in dogs In the dog 28-day study, dose levels of 0, 1, 10 and 20 mg/kg bw/d were used.  No mortality occurred but one male and one female given 20 mg/kg bw/d exhibited underactivity, hunched posture and a number of signs indicative of neurological disturbance including head nodding, facial twitching, continuous swallowing and abnormal posture or jerking of the forelimbs.  Evidence of a convulsive episode in another dog was noted on Day 9 although the animal recovered gradually.  At 10 mg/kg bw/d, the only clinical signs were head nodding and outstretched forelimbs in one female in Weeks 4 and/or 5.  Neurological examinations also revealed exaggerated flexor reflexes in two high dose animals and an abnormal head nodding episode in one female.  Food consumption was reduced at the highest dose level, particularly during Weeks 2 and 3 whilst bodyweight was initially reduced in some animals although, again, some recovery was evident.  Red blood cell parameters (PCV, hemoglobin concentration and erythrocyte count) were increased at 20 mg/kg bw/d and in two dogs at 10 mg/kg bw/d.  The only clinical chemistry findings were slightly higher protein and albumin levels.  There were no organ weight or histopathological changes.  The neurological findings detected in this study were not unexpected bearing in mind the action of the test substance on the g-aminobutyric acid (GABA) receptor.  Reductions in food consumption and associated bodyweight loss were indicative of non-specific toxicity whilst the underactivity could also reflect this or be a neurological response.  The changes in red blood cells may have been reflected hemoconcentration due to water imbalance or altered behaviour and nutritional status.  Based on some increases in red cell parameters and neurological signs at 10 mg/kg bw/d, the No Observed Effect Level (NOEL) in this 28-day dog study was 1 mg/kg bw/d. The 90-day dog study used dose levels of 0, 0.5, 2 and 10 mg/kg bw/d.  Overt toxicity was seen at 10 mg/kg bw/d since three animals were killed for humane reasons within the first 2 weeks of treatment following convulsive episodes.  Clinical signs of general toxicity included inappetence, underactivity, hunched posture and emaciation which were particularly marked during the first two or three weeks of treatment.  Tremors and/or convulsions and/or head nodding were indicative of neurological disturbance.  Similar findings, as well as facial twitching and ataxia in one female were seen during veterinary examinations and exaggerated blink and gag reflexes and depressed tactile placing responses were noted during neurological evaluations.  Bodyweight loss or stasis occurred in Week 1 at 10 mg/kg bw/d but the surviving male recovered.  Overall bodyweight gain in the other dogs at this dose level was similar to controls.  At 2 mg/kg bw/d, transitory weight loss or stasis was seen in two females.  Food consumption was markedly lower at 10 mg/kg bw/d during Week 1 with inappetence from Day 1 but, again at 2 mg/kg bw/d, only two females showed inappetence during Week 2.  These findings were associated with high alkaline phosphatase and low cholesterol activity in males given 10 mg/kg bw/d.  There were no direct treatment-related histopathological changes.  The follicular and parafollicular atrophy of the mesenteric lymph nodes and cortical atrophy of the thymus in one male and cortical atrophy of the thymus in one female at 10 mg/kg bw/d were considered to be due to stress rather than a direct effect of the test substance.  Based on the slight inappetence and depression of bodyweight in females at 2 mg/kg bw/d, the No Observed Effect Level (NOEL) was 0.5 mg/kg bw/d. Two one-year studies were conducted in dogs with dose levels of 0, 0.2, 2 and 5 mg/kg bw/d in one study and with 0, 0.075, 0.3, 1 and 3/2 mg/kg bw/d in the other.  Following significant toxicity, the highest dose in the second study was reduced to 2 mg/kg bw/d after 38 days of treatment.  In both studies, clinical signs indicative of neurological disturbance were seen at dose levels of 1 to 5 mg/kg bw/d and included convulsions, twitching or tremors, changes in behaviour (nervousness or aggression) and activity patterns, and gait abnormalities.  Other signs were exaggerated rigidity or stiffness of limbs, ataxia, vocalisation, head nodding and resistance to dosing.  Although the signs at 2 and 5 mg/kg bw/d were confirmed by veterinary and specific neurological examinations, no similar confirmation was obtained in the second study at 3/2 mg/kg bw/d, apart from one male which showed extensor flexor withdrawal.  No clinical signs were seen at 0.3 mg/kg bw/d or below.  Transitory periods of food inappetence were seen at 5 mg/kg bw/d in dogs showing clinical signs but only one male showed reduced body weight gain.  There were no other treatment-related effects, including no histopathological changes. The No Observed Adverse Effect Level (NOAEL) in the first study was 0.2 mg/kg bw/d and the No Observed Effect Level (NOEL) in the second study was 0.3 mg/kg bw/d. Short term inhalation tox A 10-day inhalation toxicity range finder exposure of Sprague-Dawley CD rats to the technical (micronized) test substance for 4 hours each day for a 10 day period, at an aerosol chamber concentration as low as 0.005 mg/L (low dose) produced higher liver weights and at 0.050 and 0.101 mg/L also produced lower body weights, reduced food consumption, clinical signs which included cold to the touch, convulsions, gasping, dilated pupils, decreased activity and salivation. At a dose level of 0.101 mg/L two mortalities were observed. Therefore, concentrations of 0, 0.001, 0.005, or 0.03 mg/L were chosen for the main 28-d study. A full 28-day inhalation toxicity study was evaluated by EPA. In this study the highest dose tested gave no signs of treatment related toxicity. EPA evaluated the study to have a NOAEL of 0.03 mg/kg /day. Short term dermal toxicity study in rats In a  28 day dermal toxicity study in male and female rats given doses of 0, 100, 500 and 1000 mg/kg bw/day no treatment related adverse effects were detected. Short term dermal toxicity study in rabbits In a 21-day dermal toxicity study one male and one female rabbit given the highest test substance dose level, 10 mg/kg bw/d, exhibited a period of extreme hyperactivity near the end of the study.  Both recovered however, the findings in the present study were considered to be treatment-related.  Overall bodyweight gain was significantly reduced in males at this dose level. Therefore, the No Observed Effect Level (NOEL) was 5 mg/kg bw/d.                Summary of short-term toxicity   Species   Duration and route Test material purity (%)   Dose levels   NOEL/NOAEL   Reference   Rat Dietary 28-day 93 0, 25, 50, 100, 200 and 400 ppm NOEL: <25 ppm (males: 3.4 mg/kg bw/d; females: 3.5 mg/kg bw/d) Peters, 1990 DocID R010256 Dog Capsule 28-day 97.2 0, 1, 10 and 20 mg/kg bw/d NOEL: 1 mg/kg bw/d Holmes, 1991 DocID R010259 Rat Dietary 90-day 95.4 0, 1, 5, 30 and 300 ppm NOEL: 1 ppm (males: 0.07 mg/kg bw/d; females: 0.07 mg/kg bw/d) NOAEL:5 ppm (males: 0.33 mg/kg bw/d; females: 0.37 mg/kg bw/d) Holmes, 1991 DocID R010262 Dog Capsule 90-day 95.4 0, 0.5, 2 and 10 mg/kg bw/d NOEL: 0.5 mg/kg bw/d Holmes, 1991 DocID R010274 Dog Capsule 1-year 96.8 0, 0.2, 2 and 5 mg/kg bw/d NOEL: 0.2 mg/kg bw/d Holmes, 1992 DocID R010290 Dog Dietary 1-year 95.7 0, 0.075, 0.3, 1 and 3/2 mg/kg bw/d NOEL: 0.3 mg/kg bw/d Holmes, 1993 DocID R010342 Rat Inhalation 10-day 95 0,005, 0.01, 0.05, 0.1 mg/L 0.005 mg/L Viau 1997 DocID R10425 Rat Inhalation 28 day   0, 0.001, 0.005, or 0.03 mg/L 0.03 mg/L EPA evaluation 2019/2072180,2019/2072204 Rat Dermal, 28-day 94.95 0, 100, 500, 1000 mg/kg bw/d NOAEL: 1000 mg/kg bw/d Henwood, 1997 R010418 Rabbit Dermal 21-day 96.7 0, 0.5, 1, 5 and 10 mg/kg bw/d NOEL: 5 mg/kg bw/d Hermansky, Wagner, 1993 DocID R010329               Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): The quality of the whole database is high. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The quality of the whole database is high. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The quality of the whole database is high. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb9fe428-ecef-4954-9902-b994ec66b349/documents/175cf91b-ddc6-4052-acc8-33b5282b7ede_e3ffe0eb-840b-4f3a-b3a5-74308d0c6bc9.html,,,,,, "fipronil (ISO); (±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinyl-pyrazole-3-carbonitrile",120068-37-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb9fe428-ecef-4954-9902-b994ec66b349/documents/175cf91b-ddc6-4052-acc8-33b5282b7ede_e3ffe0eb-840b-4f3a-b3a5-74308d0c6bc9.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "fipronil (ISO); (±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinyl-pyrazole-3-carbonitrile",120068-37-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb9fe428-ecef-4954-9902-b994ec66b349/documents/175cf91b-ddc6-4052-acc8-33b5282b7ede_e3ffe0eb-840b-4f3a-b3a5-74308d0c6bc9.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,0.03 mg/L,,rat "fipronil (ISO); (±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinyl-pyrazole-3-carbonitrile",120068-37-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb9fe428-ecef-4954-9902-b994ec66b349/documents/175cf91b-ddc6-4052-acc8-33b5282b7ede_e3ffe0eb-840b-4f3a-b3a5-74308d0c6bc9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.33 mg/kg bw/day,,rat "fipronil (ISO); (±)-5-amino-1-(2,6-dichloro-α,α,α-trifluoro-para-tolyl)-4-trifluoromethylsulfinyl-pyrazole-3-carbonitrile",120068-37-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb9fe428-ecef-4954-9902-b994ec66b349/documents/175cf91b-ddc6-4052-acc8-33b5282b7ede_e3ffe0eb-840b-4f3a-b3a5-74308d0c6bc9.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.03 mg/L,no adverse effect observed, "Flue dust, lead-refining",69029-67-0, Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. At least one component has reliable and good quality evidence from human cases or epidemiological studies or animal studies with significant and/or severe toxic effects at low oral/inhalation exposure concentrations. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c347b3a3-a94d-4bbf-9700-2ff1ed5e5bd7/documents/1d8b80e7-9d7d-4e70-88e9-20bc957cf987_6472e1d9-8e85-47ba-8625-8185f06ae218.html,,,,,, "Flue dust, lead-refining",69029-67-0,The acute toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c347b3a3-a94d-4bbf-9700-2ff1ed5e5bd7/documents/1da958ff-ae3c-4621-85a6-486b96ad8e4f_6472e1d9-8e85-47ba-8625-8185f06ae218.html,,,,,, "Flue dust, portland cement",68475-76-3, The NOAEC for inhalation systemic toxicity was determined to be at least 61.0 mg/m3. The LOAEC for inhalation local toxicity was determined to be 5.09 mg/m3. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10aecd51-1926-449a-aa18-88a91c9ce528/documents/903b09a5-0023-4d9b-89ec-aedf194f64fd_f9501db6-d492-47bb-9456-544a09db51cb.html,,,,,, "Flue dust, portland cement",68475-76-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10aecd51-1926-449a-aa18-88a91c9ce528/documents/903b09a5-0023-4d9b-89ec-aedf194f64fd_f9501db6-d492-47bb-9456-544a09db51cb.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,61 mg/m3,,rat "Flue dust, portland cement",68475-76-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10aecd51-1926-449a-aa18-88a91c9ce528/documents/903b09a5-0023-4d9b-89ec-aedf194f64fd_f9501db6-d492-47bb-9456-544a09db51cb.html,Repeated dose toxicity – local effects,inhalation,LOAEC,5.09 mg/m3,adverse effect observed,rat "Flue dust, portland cement",68475-76-3,Flue Dust is not acutely toxic. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10aecd51-1926-449a-aa18-88a91c9ce528/documents/38fbcd00-4126-4f55-ac77-e66ff4966e33_f9501db6-d492-47bb-9456-544a09db51cb.html,,,,,, "Flue dust, portland cement",68475-76-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10aecd51-1926-449a-aa18-88a91c9ce528/documents/38fbcd00-4126-4f55-ac77-e66ff4966e33_f9501db6-d492-47bb-9456-544a09db51cb.html,,oral,LD50,"2,000 mg/kg bw",, "Flue dust, portland cement",68475-76-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10aecd51-1926-449a-aa18-88a91c9ce528/documents/38fbcd00-4126-4f55-ac77-e66ff4966e33_f9501db6-d492-47bb-9456-544a09db51cb.html,,dermal,LD50,"2,000 mg/kg bw",, "Flue dust, portland cement",68475-76-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10aecd51-1926-449a-aa18-88a91c9ce528/documents/38fbcd00-4126-4f55-ac77-e66ff4966e33_f9501db6-d492-47bb-9456-544a09db51cb.html,,inhalation,LC50,"6,040 mg/m3",, "Flue dust, precious metal refining",98072-44-7,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents.     ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e18173d-6f35-46c9-9a90-32c9287f5231/documents/3cc93012-b10a-4e3a-b964-7ef40532735d_2be74866-e551-4096-afd8-636fd75f3732.html,,,,,, "Flue dust, precious metal refining",98072-44-7," No information on animal testing of ""Flue dust, precious metal refining"" on acute toxicity is available. The C&L of ""Flue dust, precious metal refining"" was determined by using the “acute toxicity range estimate (ATE)” and respective rules of Regulation (EC) 1272/2006 section 3.1.3.6 “Classification of mixtures based on ingredients of the mixture”. Applying these Flue dust, precious metal refining should be classified as acute toxic category 3 (H301) via ingestion and acute toxic category 3 (H331) via inhalation. No classification is required for acute toxicity by skin contact. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e18173d-6f35-46c9-9a90-32c9287f5231/documents/23798e43-d99d-48b4-8cd3-9241438b6fcc_2be74866-e551-4096-afd8-636fd75f3732.html,,,,,, "Flue dust, precious metal refining",98072-44-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e18173d-6f35-46c9-9a90-32c9287f5231/documents/23798e43-d99d-48b4-8cd3-9241438b6fcc_2be74866-e551-4096-afd8-636fd75f3732.html,,oral,LD50,> 50 mg/kg bw,adverse effect observed, "Flue dust, precious metal refining",98072-44-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e18173d-6f35-46c9-9a90-32c9287f5231/documents/23798e43-d99d-48b4-8cd3-9241438b6fcc_2be74866-e551-4096-afd8-636fd75f3732.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Flue dust, precious metal refining",98072-44-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e18173d-6f35-46c9-9a90-32c9287f5231/documents/23798e43-d99d-48b4-8cd3-9241438b6fcc_2be74866-e551-4096-afd8-636fd75f3732.html,,inhalation,LC50,> 0.5 mg/L,adverse effect observed, "Flue dust, zinc-refining",69012-63-1,"Studies demonstrated an overall non classification of the intermediate for acute toxicity (oral, inhalation, dermal) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08595df8-ce48-4fa9-bbb7-fdd8db27869e/documents/IUC5-af9a1efc-2ddf-4661-ae4e-57f65a45c969_13771212-b89b-44ad-8952-0351ca0c4563.html,,,,,, Fluometuron,2164-17-2,"Subchronic (90-day) study oral (gavage), rat (CDF/CrlBR (F-344)) m/f, (OECD guideline 408 (1981)): NOAEL: = 7.5 ppm equivalent to mean daily intakes of 5.9 mg/kg/day (male) and 6.5 mg/kg/day (female)Subacute (28-day) study dermal (occlusive), rabbit (New Zealand White) m/f, ((EU Method B.9 (Repeated Dose (28 Days) Toxicity (Dermal)): NOEL: 1000 mg/kg bw/day (male/female) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/212788be-4c84-42a1-98c3-75eed337d471/documents/IUC5-14613aed-a1e5-4b54-9735-f4b0d1f8bcd2_746e1c06-a312-47df-a733-29b6eef0c659.html,,,,,, Fluometuron,2164-17-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/212788be-4c84-42a1-98c3-75eed337d471/documents/IUC5-14613aed-a1e5-4b54-9735-f4b0d1f8bcd2_746e1c06-a312-47df-a733-29b6eef0c659.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rabbit Fluometuron,2164-17-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/212788be-4c84-42a1-98c3-75eed337d471/documents/IUC5-14613aed-a1e5-4b54-9735-f4b0d1f8bcd2_746e1c06-a312-47df-a733-29b6eef0c659.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5.9 mg/kg bw/day,,rat Fluometuron,2164-17-2,"1. - Acute (one single dose) study oral (gavage), rat m/f, (EPA FIFRA, Subdivision F, §81-1 (1984) = EEC B.1 (1992): LD50 > 5000 mg/kg bodyweight. 2. - Acute (single 4 hour exposure) study inhalation, rat m/f, EPA FIFRA, Subdivision F, §81-3 (1984) = EEC B.2 (1992): LC50 > 4.62 mg/l (technical limit)3. - Acute (one single application) study dermal, rabbit m/f, EPA FIFRA, Subdivision F, §81-2 (1984) = EEC B.3 (1992): LD50 > 2000 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/212788be-4c84-42a1-98c3-75eed337d471/documents/IUC5-54f2a80a-9d64-472d-bb7a-722725289aa1_746e1c06-a312-47df-a733-29b6eef0c659.html,,,,,, Fluorine,7782-41-4," Effects of repeated fluoride exposure in experimental animals were seen on the teeth, bones, respiratory tract and kidney. Evidence from epidemiological studies in humans also indicates that prolonged exposure to fluoride causes dental and skeletal effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee1525c8-bc49-4730-b1f3-596cd22dd232/documents/1b9371ae-ecf2-4fb7-acac-3ac47e2fef60_bae7d91e-0cf6-4f23-8fdc-f9afde6bcc0f.html,,,,,, Fluorine,7782-41-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee1525c8-bc49-4730-b1f3-596cd22dd232/documents/1b9371ae-ecf2-4fb7-acac-3ac47e2fef60_bae7d91e-0cf6-4f23-8fdc-f9afde6bcc0f.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.72 mg/m3,,rat Fluorine,7782-41-4," Waivers are appropriate for acute oral, dermal and inhalation toxicity as fluorine is a corrosive substance and additionally is already classified as Acute Toxicity Inhalation, Category 2 (H330, Fatal if inhaled) under CLP. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee1525c8-bc49-4730-b1f3-596cd22dd232/documents/f75e5fe0-d357-44b4-a021-ba3de1b3a6d4_bae7d91e-0cf6-4f23-8fdc-f9afde6bcc0f.html,,,,,, Fluorobenzene,462-06-6,Oral: LD50 = 7593.75 mg/kg bw (f); mouse; similar to OECD TG 423; GLP not specified; K2  Inhalation: LC50 ≥ 24.7 mg/L (male); rat; similar to OECD TG 403; GLP; K2  Dermal: no data available ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc2dd5cd-c88f-41f8-b584-2bd612e24242/documents/89516142-b7c9-4ce8-96bc-90b86f3a1b2b_f6e79372-84b3-4e95-88b8-ae96ff58c054.html,,,,,, Fluorobenzene,462-06-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc2dd5cd-c88f-41f8-b584-2bd612e24242/documents/89516142-b7c9-4ce8-96bc-90b86f3a1b2b_f6e79372-84b3-4e95-88b8-ae96ff58c054.html,,oral,LD50,"7,593.75 mg/kg bw",adverse effect observed, Fluorobenzene,462-06-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc2dd5cd-c88f-41f8-b584-2bd612e24242/documents/89516142-b7c9-4ce8-96bc-90b86f3a1b2b_f6e79372-84b3-4e95-88b8-ae96ff58c054.html,,inhalation,LC50,>=24.7 mg/L,no adverse effect observed, Fluoroethylene,75-02-5,"24-Month inhalation, rat LOAEL = 25 ppm (47 mg/m3), Reliability = 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6641f98-b1a4-4b89-b6dc-5e07e76c02ef/documents/7bba954d-0d55-413c-bc7a-ee2d651f3574_4e7d5d5b-2e9f-480f-9db6-d1e1200cf99c.html,,,,,, Fluoroethylene,75-02-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6641f98-b1a4-4b89-b6dc-5e07e76c02ef/documents/7bba954d-0d55-413c-bc7a-ee2d651f3574_4e7d5d5b-2e9f-480f-9db6-d1e1200cf99c.html,Chronic toxicity – systemic effects,inhalation,LOAEC,47 mg/m3,,rat Fluoroethylene,75-02-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6641f98-b1a4-4b89-b6dc-5e07e76c02ef/documents/7bba954d-0d55-413c-bc7a-ee2d651f3574_4e7d5d5b-2e9f-480f-9db6-d1e1200cf99c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"2,500 ",no adverse effect observed, Fluoroethylene,75-02-5,"Oral LD50: no data Inhalation, LC50, rat >100000 ppm (188000 mg/m3) air, Reliability = 2 Dermal LD50: no data ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6641f98-b1a4-4b89-b6dc-5e07e76c02ef/documents/604afc54-5d51-4092-8f2e-8fc5c842482d_4e7d5d5b-2e9f-480f-9db6-d1e1200cf99c.html,,,,,, Fluoroethylene,75-02-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6641f98-b1a4-4b89-b6dc-5e07e76c02ef/documents/604afc54-5d51-4092-8f2e-8fc5c842482d_4e7d5d5b-2e9f-480f-9db6-d1e1200cf99c.html,,inhalation,,"> 100,000 ",no adverse effect observed, "Formaldehyde, oligomeric reaction products with 4,4'-isopropylidenediphenol and diethylenetriamine",77138-45-5, Endpoints waived due to corrosivity. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7d9ac72-2428-4bb7-b867-ca2470e3c7e3/documents/cf3adbee-fd17-4bf0-ad8a-76829b177c90_24435de3-885d-49d0-91c0-f4868d0ad899.html,,,,,, "Formaldehyde, oligomeric reaction products with acetone and diphenylamine",9003-80-9," 28-day repeated dose toxicity study in rats by oral gavage. NOAEL: 50 mg/kg (based on adverse microscopic alterations in the liver and associated changes in clinical pathology parameters in both sexes, and reduced body weight gain and food consumption in females at the higher dose levels). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18bf48ae-e7a8-49c0-aa39-b26c43d8aced/documents/b0b0f26d-ca1b-419c-aea6-b48c0bd381f1_f853f1c8-b351-4cb5-9b7f-b0d09d002e64.html,,,,,, "Formaldehyde, oligomeric reaction products with acetone and diphenylamine",9003-80-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18bf48ae-e7a8-49c0-aa39-b26c43d8aced/documents/b0b0f26d-ca1b-419c-aea6-b48c0bd381f1_f853f1c8-b351-4cb5-9b7f-b0d09d002e64.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Formaldehyde, oligomeric reaction products with acetone and diphenylamine",9003-80-9, Acute toxicity via oral route LD50 >5000 mg/kg/bw in female Wistar rats. Acute toxicity via dermal route LD50 >2000 mg/kg bw in male/female Wistar rats. Acute toxicity via inhalation route LD50 >5000 mg/m3 bw in male/female Wistar rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18bf48ae-e7a8-49c0-aa39-b26c43d8aced/documents/6d505ff7-4029-4c32-b198-90de62678e0d_f853f1c8-b351-4cb5-9b7f-b0d09d002e64.html,,,,,, "Formaldehyde, oligomeric reaction products with acetone and diphenylamine",9003-80-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18bf48ae-e7a8-49c0-aa39-b26c43d8aced/documents/6d505ff7-4029-4c32-b198-90de62678e0d_f853f1c8-b351-4cb5-9b7f-b0d09d002e64.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Formaldehyde, oligomeric reaction products with acetone and diphenylamine",9003-80-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18bf48ae-e7a8-49c0-aa39-b26c43d8aced/documents/6d505ff7-4029-4c32-b198-90de62678e0d_f853f1c8-b351-4cb5-9b7f-b0d09d002e64.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Formaldehyde, oligomeric reaction products with acetone and diphenylamine",9003-80-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18bf48ae-e7a8-49c0-aa39-b26c43d8aced/documents/6d505ff7-4029-4c32-b198-90de62678e0d_f853f1c8-b351-4cb5-9b7f-b0d09d002e64.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Formaldehyde, oligomeric reaction products with aniline",25214-70-4,"The most relevant assessment of repeated dose toxicity in animals comes from an oral subchronic study with 4,4'-methylenedianiline (MDA) in rats (Ciba-Geigy, 1982). In this study rats were administered via the drinking water with 0, 80, 400 and 800 ppm MDA over a period of 3 months, followed by a 4-week recovery period. The calculated average intake of MDA was 0, 7.5, 23 and 31 mg/kg bw/day for males as well as 0, 8.0, 22 and 32 mg/kg bw/day for females. This study was accepted as valid restricted by missing ophthalmology examination. No animal died. Depressed body weight, food and water consumption was observed at 400 ppm and above. Hemotoxic effects indicated by anemia and extramedullary hemopoiesis in the spleen were evident in mid and high dose animals. Histopathological examination of the rats receiving 800 ppm revealed moderate or marked hyperplasia of small biliary ducts with initial fibrosis in the peripheral parts of the liver lobules. The changes persisted during the post-exposure period. Slight, moderate, or marked hypertrophy of the thyroid follicular epithelial cells, and diffuse hyperplasia of the glandular structures with marked colloid depletion, was noted in 90% of males and all females. At the end of the post-exposure period only 30% males and 20% females showed slight stimulation of the follicular epithelium. The rats receiving 400 ppm MDA displayed similar histopathological changes of a less severe nature. Elevated liver transaminase activities were observed at 400 ppm and above. One male rat of the high dose group and one male and one female of the mid dose groups showed a focal nodular hyperplasia of the thyroid. Histopathological examination of the rats receiving 80 ppm MDA did not find any liver lesions. Slight stimulation of the thyroid follicular epithelial cells was observed in 2/20 males and 2/20 females at 80 ppm. Kidney mineralisation was seen in all males of the mid dose group and in 21/30 males of the high dose group. One male of the 80 ppm group and none of the control males showed kidney mineralisation. The LOAEL in both sexes was identified to be 80 ppm (equivalent to 7.5 mg/kg bw/day in males and 8.0 mg/kg bw/day in females).   The primary target organs liver and thyroid were also confirmed in subchronic (13 weeks) and chronic (2 years) drinking water studies with 4,4'-methylenedianiline (MDA) dihydrochloride in rats and mice (NTP, 1983). The LOAEL from the subchronic Ciba-Geigy study is corresponding to the LOAEL of 150 ppm from the 2-year rat study on non-neoplastic effects (equivalent to 9.0 mg/kg bw/day in males and 10.0 mg/kg bw/day in females). Although the NTP-studies had not examined parameters of hematology, clinical chemistry and urinalysis, the LOAEL of 9.0 mg/kg bw/day from the long-term study in rats was considered to be the most appropriate value for quantitative risk assessment. This LOAEL is in line with the result of the 13-week study in rats. For mice a NOAEL of 100 ppm could be derived from the subchronic NTP-study (equivalent to 11.4 mg/kg bw/day in males and 14.4 mg/kg bw/day in females). The dermal application of 4,4' diaminodiphenylmethane (MDA) to rats at doses of 3, 30, 60 or 90 mg/kg bw/day (6 hours/day, 5 days/ week) for 10 weeks, resulted in skin lesions both macroscopically (scabs) and microscopically (dermatitis). The NOEL for skin lesions was 3 mg /kg bw/day. However, systemically there were no treatment-related findings and the NOEL for systemic toxicity was 90 mg/kg bw/day (Williams, 1998).   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a24b4247-c83f-4b70-a199-8caab97e1057/documents/IUC5-f3ad63d0-e3c7-4454-a2b1-56accd836758_25120410-1912-46ba-8141-1341e4ea35d1.html,,,,,, "Formaldehyde, oligomeric reaction products with aniline",25214-70-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a24b4247-c83f-4b70-a199-8caab97e1057/documents/IUC5-f3ad63d0-e3c7-4454-a2b1-56accd836758_25120410-1912-46ba-8141-1341e4ea35d1.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,7.5 mg/kg bw/day,,rat "Formaldehyde, oligomeric reaction products with aniline",25214-70-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a24b4247-c83f-4b70-a199-8caab97e1057/documents/IUC5-f3ad63d0-e3c7-4454-a2b1-56accd836758_25120410-1912-46ba-8141-1341e4ea35d1.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,3 mg/kg bw/day,,rat "Formaldehyde, oligomeric reaction products with aniline",25214-70-4,"Read-across to 4,4' MDAOral LD50 is 444 mg/kg bw.Dermal LD50 was affected by the vehicle and ranged from 1000 mg/kg bw for females when administered in DMSO to >2500 mg/kg bw in aqueous solution.Inhalation, no mortality in rats with highest technically feasible and respirable inhalation atmosphere. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a24b4247-c83f-4b70-a199-8caab97e1057/documents/IUC5-2b4027dd-d0d3-409b-b1f8-7394a62148eb_25120410-1912-46ba-8141-1341e4ea35d1.html,,,,,, "Formaldehyde, oligomeric reaction products with aniline and phosgene",32055-14-4,"Description of Key information The test substance is part of a category approach of methylenediphenyl diisocyanates (MDI) with existing data gaps filled according to ECHA guidance on Read Across (ECHA, 2017).  The read-across category justification document is attached in IUCLID section 13 and summarized below in Additional Informaiton.  Data-gaps in this endpoint is satisfied by weight of evidence and read across from valid repeated dose toxicity studies for the inhalation route. Reliable repeated dose inhalation data in animals is available for the boundary substances (4,4’-MDI, pMDI and 4,4’-MDI/DPG/HMWP). The chronic repeated dose toxicity study (Reuzel et al. 1994, reliability 2) performed with pMDI is a guideline study (OECD 451). In addition, valid sub-chronic and sub-acute repeated dose toxicity studies are available  for pMDI (Reuzel et al. 1994, Kilgour et al. 2002, reliability 2). For the 4,4’-MDI a valid chronic inhalation toxicity study is available (Hoymann et al. 1995, reliability 2) and a limited documented sub-chronic inhalation toxicity study (Heinrich et al. 1991, reliability 4). For the boundary substance 4,4’-MDI/DPG/HMWP a sub-acute toxicity study is available (Ma-Hock, 2021, reliability 1).   Proposed Testing: To support this weight of evidence and read across approach additional repeated dose toxicity testing is planned. It is considered to perform a sub-chronic inhalation toxicity study (OECD 413) with boundary substance 4,4’-MDI/DPG/HMWP. Additional, combined Repeated Dose Toxicity studies with Reproductive/ developmental Toxicity Screening tests (OECD 422) will be performed on 9 substances representing all sub-groups and key structural/chemical characteristics (see overview attached in Annex 27 in Chapter 13). These screening studies will confirm the proposed MoA on repeated dose toxicity or identify substances that may require additional testing.   Available information: Several sub-acute, sub-chronic and chronic studies have been performed on 4,4’-MDI, pMDI and 4,4’-MDI/DPG/HMWP and are described in Category justification document in Chapter 13 . A repeated dose dermal toxicity study was performed in rabbits with pMDI (Wazeter et al., 1964a) but since this only has fourteen days of treatment and only slight local skin irritants effects were observed this is omitted from this chapter, but rather described in chapter addressing skin irritation. As with the acute studies, in all repeated dose studies, toxic effects were limited to the site of contact with no systemic effects observed distant from the portal of entry. Key repeated dose studies days are described below:  The ‘Monomeric MDI’ subgroup In a subchronic inhalation study with 4,4’-MDI, female Wistar rats were exposed to concentrations of MDI of 0, 0.3, 1 or 3 mg 4,4’-MDI/m3 for 18 hours a day on 5 days a week for 13-weeks. Reduced body weight gains and an increase in relative lung weights were found at 1 mg/m3 and above. At and above this concentration infiltration of mononuclear cells, goblet cell hyperplasia, erosion of the respiratory epithelium in the upper respiratory tract, hyperplasia of the bronchus-associated lymphatic tissue and inflammatory changes of the lung were additionally observed. At 3 mg/m3 there was an increase in the total cell count and proportion of granulocytes and lymphocytes, a decrease in the proportion of macrophages in the bronchoalveolar lavage fluid, an increase in protein, β-glucuronides and lactate dehydrogenase, and changes in lung function. No effects were observed at 0.3 mg/m3 (Heinrich et al., 1991). A subsequent chronic inhalation study (Hoymann et al., 1995) was conducted with 4,4’-MDI. Female Wistar rats were exposed to 0.23, 0.70 or 2.05 mg 4,4’-MDI/m³ aerosols for 17 hours/day, 5 days /week for up to 24 months. Essentially, a dose-dependent impairment of the lung function in terms of an obstructive-restrictive malfunction with diffusion disorder, increased lung weights, an inflammatory reaction with increased appearance of lymphocytes in the lung in the high dose group as a sign of specific stimulation of the immune system by MDI, an intermediately retarded lung clearance in the high dose group as well as dose-dependent interstitial and peribronchiolar fibrosis, alveolar bronchiolisations and a proliferation of the alveolar epithelium, which was classified as preneoplastic, as well as a bronchiolo-alveolar adenoma were identified. The LOAEC for the female rat was identified as 0.23 mg/m3 based on minor histopathological pulmonary lesions after long-term inhalation of 4,4'-MDI aerosols.  A comparison of the pulmonary effects described in female rats from the two chronic studies, one with 4,4’-MDI and the other with pMDI, was published by Feron et al. (2001). To assist the comparison and account for the lower proportion of mMDI in pMDI, the authors normalized the different MDI doses to total inhalation exposures calculated as 559; 1,972; 2,881; 6,001; 17,575 and 17,728 mg mMDI.h/m3. The major pulmonary effects in the two studies were characterized by hyperplasia, interstitial fibrosis and a low incidence of bronchiolo-alveolar adenoma, the latter occurring in the high exposure groups of both studies (i.e. total inhalation exposures of 17,728 and 17,575 mg.h/m3). Both studies also reported the presence of particle-laden macrophages predominantly in the alveoli close to the alveolar ducts which in some cases, particularly in high dose groups, were associated with areas of fibrosis. There was a clear quantitative dose response in both studies with the lowest dose of 559 mg mMDI.h/m3 from the study reported by Reuzel et al. (1994a) being described as the no-observed-adverse-effect-level (NOAEL) Feron et al. (2001) also suggested that the mild histopathological changes seen in the low exposure animals (0.23 mg/m3) in the Hoymann et al. (1995) study, would not have occurred if the exposure had been for six hours/day. An exposure of 0.2 mg/m3 over a six-hour period was judged to be the NOAEL in both studies. Overall, the analysis concluded that both studies showed similar qualitative responses to exposures to pMDI or 4,4’-MDI when compared on the basis of mMDI content..  The ‘Oligomeric MDI’ subgroup In a subacute inhalation study by Kilgour et al. (2002), female Alpk:APfSD rats were exposed to pMDI aerosol at  concentrations of 0, 1.0, 4.0 and 10 mg pMDI/m3, for 6 hours/day, 5 days/week, for  28 days, a 30-day recovery group was included. No clinical signs were noted during exposure and recovery phase. Body weights in all groups were comparable to controls throughout exposure and recovery periods. Lung weights were increased in animals exposed to 10 mg/m3 at the end of the exposure period, although this had returned to control values by day 30 post-exposure. Lung weights of all other treated groups were in the range of the control group. A dose-dependent influx of inflammatory cells, total protein levels and increase in enzyme activities indicated an inflammatory reaction. A statistically significant increase in both the total number of cells counted and alveolar macrophages in lavage fluid was noted at 10 mg/m3, and a slight (but not statistically significant) following exposure to 4 mg/m3. The polymorphonulear leukocytes (PMNs) and lymphocyte/other cells showed statistically significant, concentration-related increases in cell counts following exposure to 4 or 10 mg/m3 pMDI. At the end of the recovery phase, cell counts in exposed animals had returned to normal. Animals of the exposure groups 4 and 10 mg/m3 showed an increase of macrophages containing vacuoles (foamy macrophages), whereas the 1 mg/m3 group was in the range of the control animals. At the end of the recovery period few macrophages vacuoles were still discernable. In animal exposed to 10 mg/m3 pMDI a statistically significant increase in total protein and alkaline phosphatase activity was noted in lavage fluid at the end of exposure, whereas lactate dehydrogenase and N-acetyl glucosaminidase (NAG) activities were not increased. All other treated groups in the main study and all groups at the end of the recovery phase showed values similar to controls. A transient increase in phospholipids concentration was noted in the lavage fluid from animals exposed to 10 mg/m3 pMDI after exposure, no differences from control values were seen at the end of the recovery phase. In all exposure groups a statistically significant concentration-related increase in BrdU labelling index in terminal bronchioles were seen; a similar increase in centro-acinar alveoli were found in animals exposed to 4 and 10 mg/m3 pMDI. At the end of the recovery phase, labelling indices were similar to control values at all concentrations. No macroscopic abnormalities were noted. Histopathology of the lung showed in animals exposed to 10 mg/m3 pMDI an increase in bronchiolitis and thickening of the centro-acinar region, interstitial thickening at the acinar junctions, and accumulations of alveolar macrophages containing yellow pigment in the cytoplasm. In animals exposed to 4 mg/m3 pMDI 1/5 animals showed thickening of the centro-acinar region and bronchiolitis and 1/5 animals exposed to 1 mg/m3 pMDI showed bronchiolitis. After the recovery phase, alveolar macrophages containing a yellow pigment were present in the interstitium in all animals that had been exposed to 10 mg//m3 pMDI but were absent in animals exposed to 1 or 4 mg/m3 pMDI. In addition, 1/5 animals exposed to 10 mg/m3 pMDI still had bronchiolitis and centro-acinar thickening, but at a reduced severity and distribution to that seen in the main study. Ultrastructural findings suggest a perturbation of surfactant homeostasis by exposure to pMDI which is supported by the small increase in measured phospholipids and observation of foamy macrophages. Animals exposed to 10 mg/m3 pMDI showed a slight thickening of the interstitial alveolar wall in 3/5 animals. The thickening in the centro-acinar region was due to thickening of the interstitium, which partly attributable to the absorption of alveolar macrophages and partly due to excess collagen. Compound -related increases in the levels of surfactant were noted in the alveolar macrophages and lumina. In the alveolar macrophages, minimal to slight increases in lamellar surfactant were associated with minimal and moderate increases in amorphous surfactant in animals exposed to 10 mg/m3 pMDI.  In the alveolar lumina, minimal to moderate increase in cell debris were noted in animals exposed to 10 or 4 mg/m3 pMDI. Associated with these increases in cell debris were increases in the amount of crystalline and lamellar surfactant. At 1 mg/m3 there was evidence of effect on surfactant homeostasis, with small increase in number and size of type II cell lamellar bodies and similar increases in  amorphous, crystalline and lamellar surfactant in the  alveolar lumina, which was seen as an adaptive response to exposure to low levels of irritant aerosol. Based on findings of histopathology, bronchiolitis noted at 1 mg/m3 and evidence of effect on surfactant homeostasis at 1 mg/m3, NOAEC could not be defined and the LOAEC was set at 1 mg/m3 pMDI.   In a subchronic inhalation study (SC1) by Reuzel et al. (1994b) (original report Reuzel et al. (1985)) Wistar rats were exposed to pMDI aerosol at concentrations of 0, 0.35, 1.4 and 7.2 mg pMDI/m3, for 6 hours/day, 5 days/week over a period of 13 weeks. Transient slight growth retardation was observed in male rats exposed to 7.2 mg/m3 air. Haematology, blood chemistry and urinalysis did not show treatment-related effects. There were no significant differences in organ weights between the test and control groups. Gross examination at autopsy did not reveal changes which could be ascribed to the test substance. Histopathological examination revealed yellow material (possibly polyurea originated from test material) in the respiratory tract of rats exposed to 7.2 mg/m3. Under the conditions of this test no clear NOAEC was determined. In an associated second subchronic study (SC2) by Reuzel et al. (1994b) (original report by (Reuzel et al., 1986)), Wistar rats were exposed to higher aerosol concentrations of 4.1, 8.4 and 12.3 mg pMDI /m3 air for 3-months. Severe respiratory distress was observed in rats exposed to 12.3 mg/m3 with 11 males and 4 females dying during the exposure period. Significantly less severe signs were seen in rats exposed to 8.4 mg/m3. This study demonstrated adverse effects in the lungs and nasal cavity at levels of 4.1 mg/m3 and above and included histological effects in the lungs (increase in alveolar macrophages and interstitial macrophage infiltration) and in the mediastinal lymph nodes (macrophages with yellowish inclusions). At 8.4 mg/m³ and above increased relative lung weights, partially reversible damage to the olfactory epithelium and basal cell hyperplasia were observed.   In a combined chronic toxicity and carcinogenicity key study (Reuzel et al., 1990; Reuzel et al., 1994a) conducted according to OECD Guideline 453 rats were exposed for 6 hours/day, 5 days/week for one year (satellite groups) or two years (main groups) to aerosol concentrations of 0, 0.2, 1.0 or 6.0 mg pMDI /m3 (analytical concentrations: 0, 0.19, 0.98, 6.03 mg/m3). The effect of chronic exposure of rats to respirable pMDI aerosol was confined to the respiratory tract. The compound-related changes were found in the nasal cavity, the lungs and the mediastinal lymph nodes, and to some degree they were already present after one year of exposure. Histopathology of the organs/tissues investigated showed that exposure to 6.0 mg/m3 over two years was related to the occurrence of pulmonary tumors in males (6 adenomas and 1 adenocarcinoma) and females (2 adenomas). In this two-year rat study, the NOAEC was 0.2 mg/m3 for the repeated dose toxicity of pMDI. The LOAEC was set at 1.0 mg/m3.   The ‘MDI and its reaction products with glycols’ subgroup Pre-liminary results are available for a subacute inhalation study (Ma-Hock, 2021) which was conducted according to OECD 412 on 4,4’-MDI/DPG/HMWP. This study was designed as closely as possible to the study described above by Kilgour et al. (2002) on pMDI to generated comparable data on 2 category boundary substances.  A qualitative and quantitative comparison between these studies will be described in more detail in the category justification document attached to this dossier.   Male and female Wistar rats (7 animals per sex and exposure group) were exposed to 4,4’-MDI/DPG/HMWP liquid aerosol at  concentrations of 0, 1.0, 4.0 and 10 mg/m3 (analytical conc.: 0, 1.0, 3.9 and 9.8 mg/m3), for 6 hours/day, 5 days/week, for  4 weeks (main study). To evaluate the reversibility of effects, 28-day recovery groups were included (recovery control group and 10 mg/m3 exposure group). No mortality was observed throughout the study. During the exposure period clinical signs like respiration sound and piloerection were noted in animals exposed to 10 mg/m3 and one animal exposed to 4 mg/m3. In all other animals, no clinical signs were observed during the exposure period. No clinical signs were observed during the recovery period. Body weights of males exposed to 10 mg/m3 was slightly lower throughout the exposure period but were in the range of the concurrent control at the end of the recovery period. All other groups were comparable throughout exposure and recovery period. A significant increase in mean relative lung weights was observed in males and females of the 10 mg/m3 exposure group, although this had returned to control values at the end of the recovery period. Regarding clinical chemistry, one female of exposure group 4 mg/m3 and 2 females of exposure group 10 mg/m3 (main study) showed an increase in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activities. These effects were regarded as caused by the implant of Alzet osmotic minipumps, thus regarded as treatment related but not substance related effect. All other changes in clinical chemistry observed in exposed animals were regarded as incidental and not treatment related. In animals exposed to 10 mg/m3 a lymphocytic-monocytic inflammation was observed indicated by increased total cell counts as well as absolute and relative lymphocyte and monocyte counts. This type of inflammation was confirmed by marginal, non-relevant increases of lactate dehydrogenase (LDH BAL) and alkaline phosphatase (ALP BAL) activities, but relevantly, slight increases of γ-glutamyl transferase (GGT BAL) activities among these individuals. In BAL of rats exposed to 10 mg/m3 increases of high total protein levels were observed. At the end of the recovery period total protein levels and enzyme activities and cell counts had returned to control levels. Treatment-related histopathological findings were observed in lungs, trachea, larynx, tracheobronchial lymph nodes and mediastinal lymph nodes in male and female animals. Interstitial inflammation of the terminal bronchi was observed in animals exposed to 4 mg/m3 and 10 mg/m3. Hypertrophy/hyperplasia of large, medium and terminal bronchi were observed in animals exposed to 4 mg/m3 and 10 mg/m3, which was associated with an increase in cell proliferation, indicated as a significant increase in BrdU labeling indices. A statistically significantly increased cell proliferation was also observed in animals exposed to 1 mg/m3 in large, medium and terminal bronchi. In alveoli there was a trend towards increased cell proliferation, however there was no dose-response relationship, statistically significance was only seen in males exposed to 10 mg/m3. Pneumocytes type II cells showed minimal proliferation in few animals of the 4 mg/m3 and 10 mg/m3 exposure group. Interstitial inflammation of alveoli was noted in males of the 4 mg/m3 and 10 mg/m3 exposure groups. In the alveolar lumina, neutrophilic infiltration was found occasionally. Debris was seen in one male of the 4 mg/m3 exposure group in alveolar lumina consisting of fragments of cells. Alveolar macrophage accumulation was seen with increased severity in males and females exposed to 10 mg/m3. A minimal increase in alveolar macrophages was still present in females at the end of the recovery period. Macrophages with foamy cytoplasm (foamy macrophages) were observed in males of the 4 mg/m3 and 10 mg/m3 exposure groups and in females exposed to 10 mg/m3. Epithelial alteration in the larynx was noted with increased incidence and severity in treated animals and was characterized by a focal, ventrally located change of the epithelium from cuboidal to focally flattened cells and was noted with increased incidence and severity in treated animals. Lymphocyte infiltration was seen in the submucosa in treated animals. The trachea epithelium on the tip of the carina was changed from its normal cuboidal, ciliated appearance to a single layer of flattened cells with loss of cilia in treated animals. Hyperplasia of the trachea epithelium was seen in males exposed to 4 mg/m3 and 10 mg/m3 and females exposed to 10 mg/m3. Beneath the epithelium, there was an increased infiltration of lymphocytes in single animals. A diffuse enlargement of mediastinal and tracheobronchial lymph nodes was seen in treated animals. The histopathological changes noted after termination of exposure were mostly reversible. An increased incidence of minimal alveolar macrophage accumulation was still observed at the end of the recovery period in treated females. Increased cell proliferation in alveoli was still observed in treated males. No other treatment related findings were observed at the end of the recovery period.   In summary, substance-related systemic effect was not observed. Under the current study conditions, the no observed adverse effect level (NOAEL) for systemic toxicity was 10 mg/m³. The NOAEL for local toxicity could not be established due to the slight changes in labeling indices present at 1 mg/m³ (Ma-Hock, 2021).   Human information A large dataset is available in human epidemiological and case studies for chronic exposure to diisocyanates in the workplace and reported effects are limited to respiratory system. Effects associated with respiratory sensitization are described in chapter sensitization and potential carcinogenicity is described in carcinogenicity chapter. In general, long term exposure to MDI substances can result in non-immunological decreases in lung function and other respiratory symptoms associated with chronic irritation. Interpretation of many of these studies is confounded by simultaneous exposure to TDI and inaccurate exposure data. Despite these limitations, pMDI concentrations as low as 87 ppb (0.9 mg/m3) were shown to correlate with deterioration in lung function whereas when exposures were below a maximum concentration of 20 ppb (0.2 mg/m3), no significant changes in lung spirometry was generally observed (DFG, 2008). The frequency of respiratory complaints was not significantly increased when exposure levels were below 10 ppb (0.1 mg/m3) (DFG, 2008).     Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint: No system toxicity up to the highest dose group tested   Inhalation is the most appropriate route of exposure for assessing occupational risk of substances of the MDI category in humans. Repeated dose studies are available for the three boundary substances , GLP compliant study on both 4,4’-MDI and pMDI with reliability 2, conducted according to OECD Guideline 453 (combined chronic toxicity/carcinogenicity studies) and two 28 day studies on pMDI and 4,4’-MDI/DEG/HMWP. In all repeated dose studies, toxic effects were limited to the site of contact with no systemic effects observed distant from the portal of entry, which is in line with the discussed MoA of MDI toxicity (see category justification document).   Repeated dose toxicity: inhalation - local effects (target organ) respiratory: respiratory tract   ​ Inhalation is the most appropriate route of exposure for assessing occupational risk of substances of the MDI category in humans. Repeated dose studies are available for the three boundary substances, GLP compliant study on both 4,4’-MDI and pMDI with reliability 2, conducted according to OECD Guideline 453 (combined chronic toxicity/carcinogenicity studies) and two 28 day studies on pMDI and 4,4’-MDI/DEG/HMWP. Consistent with the hypothesized MoA proposed (see category justification document) for these substances the primary health effect following inhalation exposure is local irritation within the respiratory tract without significant systemic exposure or toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/15e50283-fa50-4dbf-babc-7c60289cc968/documents/3c2aa6cb-5926-4781-bf26-ff77265a67f0_5ceb37bb-c8c3-45a0-973c-e3fa31982f8e.html,,,,,, "Formaldehyde, oligomeric reaction products with aniline and phosgene",32055-14-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/15e50283-fa50-4dbf-babc-7c60289cc968/documents/3c2aa6cb-5926-4781-bf26-ff77265a67f0_5ceb37bb-c8c3-45a0-973c-e3fa31982f8e.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1 mg/m3,adverse effect observed, "Formaldehyde, oligomeric reaction products with aniline and phosgene",32055-14-4,"Data gap filling for the acute inhalation toxicity endpoint is achieved using the category approach according to ECHA guidance on read-across (ECHA, 2017c). For this endpoint, all effects are consistent with the hypothesized MoA and direct electrophilic reactions of NCO with biological nucleophiles. Modified MDI substances contain different higher molecular weight constituents, and all have in common a high content of bioaccessible low molecular weight MDI constituents responsible for presenting NCO reactivity, scenario 4 or 6 according to the RAAF considered as most appropriate due to a common mechanism. Selection between scenario 4 and 6 depends essentially upon the presence of variation in the properties i.e. magnitude of effect. Since it has been demonstrated that the bioaccessible low molecular weight MDI constituents are responsible for presenting NCO reactivity, and the higher molecular weight MDI constituents do not contribute to the observed toxicity it is reasonable to assume that their presence in these mixtures attenuates toxicity. Further, as a worst-case approach is adopted in which 4,4’-MDI isomer is used for read-across to all substances of the MDI category, then use of RAAF Scenario 4 (variations in the properties observed among source substances) is justified over scenario 6.   Acute oral toxicity In the case of oral exposure, before the reactive NCO groups present on the substances of the MDI category have opportunity to react locally, or be absorbed, they polymerize in the acid environment of the stomach to form solid polyureas that are excreted via the feces without being absorbed. Consequently, if exposure were to occur by the oral route this would not lead to local or systemic effects. For MDI Mixed Isomers, the key study (Reliability 1) did not record mortality up to the limit dose of 2,000 mg/kg bw . A supporting study describing the acute oral toxicity of pMDI conducted similar to OECD 401 guideline (Reliability 2) also did not find any mortality up to the maximum dose tested, hence the LD50 is greater than 10,000 mg/kg bw . Other studies on MDI substances are consistent with this, albeit with lower reliability.  Four additional acute oral toxicity studies (Reliability 1) have been conducted on other representative substances of the category subgroups (i.e. ‘MDI, its condensation products and the reaction products with glycols’ and ‘MDI and its reaction products with glycols’). In all cases, there was no mortality up to the limit dose (5,000 mg/kg). The lack of mortality in the available acute oral toxicity across the available studies, alongside the lack of gross lesions in distal tissues (e.g. liver, kidney etc.) supports the lack of systemic bioavailability. The NCO groups present on MDI substances react with acids within the stomach leading to formation of an insoluble polymerized mass that is excreted in the feces without being absorbed (see Toxicokinetics).  Supporting evidence comes in the form of several accidental ingestion reports in dogs where ingestion of MDI based glues produced no intrinsic toxic effects other than the formation of a solid polyurea mass that may lead to gastric obstruction. When the mass was removed by surgery, rapid and complete recovery was achieved (Horstman et al., 2003; Ohngren, 2007).     Acute dermal toxicity In the case of dermal exposure, before the reactive NCO groups present on MDI substances have opportunity to be absorbed to any significant extent through the stratum corneum they react with proteins and moisture at the skin surface leading to the formation of an insoluble polymerized mass thereby limiting dermal absorption and systemic availability (Leibold 1999). Modified MDI substances, having a higher molecular weight than mMDI isomers and due to their higher molecular volume, increased octanol-water partition coefficient and decreased water solubility will in any event not be able to penetrate the stratum corneum (Bartels 2021). The available acute dermal toxicity studies indicate that all substances of the MDI category have low acute dermal toxicity. The key study describing the acute dermal toxicity of pMDI in rabbits did not find lethality up to the maximum dose tested, and the LD50 was greater than 9,400 mg/kg bw (Wazeter et al., 1964a). Other less reliable studies on pMDI or 4,4’-MDI are consistent with this.  Observed differences in LD50 values between pMDI and 4,4'-MDI/TPG are not considered to be significant or represent a trend since they are significantly higher than the limit for classification and are indicative of a lack of systemic exposure. The available data for the substances of the MDI category is consistent with the hypothesis that NCO groups present on MDI substances react with proteins and moisture at the skin surface leading to the formation of an insoluble polymerized mass resulting in limited dermal absorption and systemic availability. The available data and hypothesis is supported by the key dermal absorption study that shows that MDI substances have very low systemic bioavailability (<1 %) (Leibold et al., 1999). By comparison, modified MDI substances, with molecular weight greater than mMDI, will demonstrate even further reduced dermal absorption based upon physico-chemical properties (i.e. increased octanol-water partition coefficient, decreased water solubility, and increased molecular weight), and this has been confirmed with GastroPlus™ modeling (Bartels, 2021). Although a reliable, acute dermal in vivo toxicity data is only available on two category substances, it is considered sufficient for assessment of this endpoint for the category. Due to the low predicted dermal bioavailability of all category substances, and the lack of systemic toxicity demonstrated in the oral acute toxicity studies, additional testing is not justified as all substances of the MDI category would be predicted to have comparable or reduced acute dermal toxicity potential to tested substances.   Acute Inhalation Toxicity Following inhalation exposure the initiating event in hypothesised MoA for acute toxicity in the lung is the reaction of the MDI substance with GSH in the airway lining fluid (adduct formation). Subsequent development of toxic effects is driven by the rate of depletion of GSH. This depletion begins with the reduction in extracellular GSH, which leads to a reduction in intracellular GSH disturbing the redox balance in the cell. With increasing amounts of NCO exposure (e.g. via exposure concentration or bioaccessibility), the protective GSH system gradually becomes overwhelmed, and toxicity evolves along the path: (1) no cytotoxicity; (2) cytotoxic effects; (3) reduced cell viability; and (4) cell death. This is accompanied by increasing extravasation because of increased junction permeability and epithelial damage ultimately causing edema.    The rate of nucleophile depletion by MDI-based substances is driven by the availability of the NCO-group, which itself is a function of (1) the NCO value of the substance and (2) the molecular weight of its constituents (driving its reactive dissolution). Monomeric MDI isomers have been shown to become available at a similar rate in toxicokinetic studies (Wisnewski, 2018; Wisnewski et al., 2019a) which is consistent with the generally comparable LC50 values for all of the isomers. Conversely, higher molecular weight constituents have both a reduced NCO value and exhibit reduced water solubility, making them less accessible to react with GSH. Therefore, the substances with the highest available NCO value and bioaccessibility (mMDI and three-ring oligomers) are the most toxic, while those with increasing amounts constituents less able to react with GHS demonstrate reduced toxicity.   Tests also show that toxicity is limited to portal-of-entry effects. The absence of systemic toxicity is due to the extracellular reactions described above, combined with transcarbamoylation to proteins described in more detail in the Chapter (Toxicokinetics), constitute a detoxification mechanism. Acute toxicity is only observed when this protective mechanism becomes overwhelmed and is limited to the lung. This mode of action is supported with high confidence by reliable acute inhalation data available for multiple MDI isomers and modified MDI substances (described in more detail below). The toxicity of MDI substances will decrease with increasing average molecular weight as these substances will have constituents that are less bioaccessible and with a lower NCO value. For these substances, higher exposure concentration is required to induce toxic effects, which is consistent with the observed results from the available acute inhalation toxicity tests.  Testing proposal: While testing is available on 8 MDI category memeber (including all sub-groups) acute toxicity testing (OECD 403) will be performed on an additional 4 MDI substances.  This information will further support the category hypothesis as well as help to define substance selection and study design for repeat-dose bridging studies.    Available data: The ‘Monomeric MDI’ subgroup Reliable acute inhalation studies are available for all three isomers of mMDI (2,2’-; 2,4’-; and 4,4’-MDI) in accordance with OECD Guideline 403 in a series of studies by (Pauluhn, 2008d; Pauluhn, 2008e; Pauluhn, 2008f). All three substances consist of more than 98 % pure mMDI, corresponding to NCO value of 33%. In all cases, mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA. LC50s were comparable and ranged from 368 to 598 mg/m3 for males and from 559 to 686 mg/m3 for females. For all studies, exposure parameters met internationally recognized recommendations for MMAD and GSD and were similar for all three isomers. The ‘Oligomeric MDI’ subgroup Polymeric MDI (approximately 40 % mMDI; 33 % NCO value, with viscosity of approximately 200 mPas) was tested in an acute inhalation toxicity study according to OECD 403 (Pauluhn, 2008c). Mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA. An LC50 (95 % confidence interval) of 310.2 (266.4-361.3) mg/m3 was determined for pMDI.  Polymeric MDI was also tested following depletion of monomeric MDI resulting in a mixture of 1.2 % mMDI and 98.8 % of higher (> two-ring) oligomers according to OECD 403 (Pauluhn, 2011a). The combined LC50, for male and female rats, for ‘monomer-depleted pMDI’ was greater than 2,188 mg/m3. Average mean mass aerodynamic diameter (MMAD) and geometric standard deviation (GSD) was generally comparable to that of the pMDI containing mMDI (85-87 %). The ‘MDI and its condensation products’ subgroup The acute inhalation toxicity of MDI Mixed isomers/PIR (60 % mMDI and NCO value of 26 %) was tested in an acute inhalation toxicity study according to OECD 403 (Pauluhn, 2012). The combined LC50 for male and female rats was 1,088 mg/m3, mortality was linked to portal of entry effects of the respiratory system, including severe irritation and pulmonary edema. Mortality occurred up to two days post-exposure and was causally related to an acute pulmonary edema. The ‘MDI and its reaction products with glycols’ subgroup Two reliable acute inhalation studies are available for substances of the ‘MDI and its reaction products with glycols’ subgroup. The acute inhalation toxicity of 4,4'-MDI/1,3-BD/TPG/PG (60 % mMDI; 23 % NCO) was conducted according with OECD 403 (Kopf, 2016).  The LC50 was calculated to be 518 mg/m3, and mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA.  The acute inhalation study of 4,4'-MDI/DPG/HMWP (50 % mMDI; 25 % NCO) was tested according to OECD 403 (Hotchkiss and Weidemoyer, 2020). The LC50 is 1,110 mg/m3 for male rats and 1,250 mg/m3 for female rats. The four-hour LC50 is 1.15 mg/L for male and female rats combined. Similar to the other LC50 studies, mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA.   An acute inhalation study was performed in rats at only one concentration level of 2.24 mg/L/1h (Pauluhn 2003, 2004). This study was specifically designed to comply with NFPA 704, and also complied with the limit test of the OECD guideline 403 with deviations (only 1 hr exposure, concentration lower than limit test concentration) and is therefore reliable with restrictions. Exposure of 4,4’-MDI for 1 hr resulted in mortality shortly after exposure of one out of ten rats. Clinical signs were characterised by typical signs of respiratory tract irritation. Necropsy findings were unremarkable in surviving rats, whilst the rat that succumbed displayed signs of lung oedema which was considered to be the cause of death. The LC50 >2.24 mg/L/1h (analytical) in both males and females was determined.        Adequacy of the available data for risk assessment and classification purposes Using the strict GHS LC50 cut-off for classification, the LC50 values obtained for the mMDI would trigger a Category 2 (or Category 3) according to GHS CLP. However, classification for these substances according to ECHA CLP Guidance (2017) text allows for the application of scientific judgement. It must be considered that the LC50 cut-off of 500 mg/m3 (approximately 50 ppm for pMDI), is over 2,500-fold above the saturated vapor concentration for pMDI. This difference is even further exacerbated in the pre-polymer mixtures where the presence of the higher molecular weight fraction even further reduces the vapor pressure making exposure less likely.    Furthermore, the aerosols were generated using sophisticated techniques in the laboratory, whereby extremely small particles are generated in order to meet international guidelines for testing. This size and concentration of aerosol is not generated in the workplace even under foreseeable worst-case conditions (Ehnes et al., 2019). The particle size distribution of aerosols formed during actual spraying applications has virtually no overlap with that of the highly respirable aerosol generated in inhalation studies (see EC (2005)). Due to a very low vapor pressure (<0.01 Pa) MDI substances are not inherently toxic by inhalation since the saturated vapor concentration would be orders of magnitude below toxic concentration. It is only with modification and input (in terms of heat, cooling and size screening) that MDI substances become toxic after inhalation. In the EU risk assessment report (EU 2005) MDI is classified as  harmful by inhalation.   The acute inhalation data of pMDI and 4,4’-MDI data were considered by EU experts, and their conclusion that MDI be classified as “Harmful” and  reported in the 25th Adaptation to Technical Progress (ATP) to the Dangerous Substances Directive (67/548/EEC). This was endorsed in the 28th ATP and both MDI substances remain as “Harmful” in the 30th ATP (adopted by Member States on 16 February 2007 and published 15th September 2008). The original decision was upheld in the EU Risk Assessment of MDI (Directive 793/93/EEC, 3rd Priority List) published in 2005, noting that considering “the exposure assessment, it is reasonable to consider MDI as harmful only and to apply the risk management phrase ‘harmful by inhalation’. This classification was also endorsed by the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE, now SCHER) in giving their opinion on the Risk Assessment (EC, 2008). With the enforcement of the CLP regulation (Regulation (EC) No 1272/2008) in 2009, the Dangerous Substance/Preparation Directive (DSD) was repealed and harmonized classifications were formally transferred to the CLP regulation; MDI is classified with Acute Tox. 4 H332 (Annex VI Regulation (EC) No 1272/2008 (CLP regu lation). Given the mechanism of action of the MDI substances and the changes in physical chemical properties imparted by the modifications in the modified MDI substances, the entire category is consistent with this guidance and classification, and the classification should not be changed.   The classification as “Harmful”, is equivalent to GHS Category 4. For these reasons, the GHS proposal follows the EU Regulatory lead accepting that the animal data are inappropriate and classified pMDI as GHS acute toxicity category 4 (ISOPA 2007).    Conclusion    Assessment of the available acute toxicity data indicates that inhalation exposure to the aerosols of MDI results in toxicity confined predominantly to the respiratory tract. In terms of hazard characterization, MDI is harmful by inhalation according to EU (H332) and GHS (Cat. 4) classification. MDI is non-toxic after single oral and dermal exposure.     Justification for classification or non classification:    EU classification according to CLP: H332     GHS classification (GHS UN rev.2, 2007): Inhalation route (vapour): Acute Category 4.     Not toxic by the dermal or oral routes. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Results are consistent within the key study Bomhard (1990) (reliability1)and data from a supporting study (Wazeter et al. 1964) (reliability 2). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15e50283-fa50-4dbf-babc-7c60289cc968/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_5ceb37bb-c8c3-45a0-973c-e3fa31982f8e.html,,,,,, "Formaldehyde, oligomeric reaction products with aniline and phosgene",32055-14-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15e50283-fa50-4dbf-babc-7c60289cc968/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_5ceb37bb-c8c3-45a0-973c-e3fa31982f8e.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Formaldehyde, oligomeric reaction products with aniline and phosgene",32055-14-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15e50283-fa50-4dbf-babc-7c60289cc968/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_5ceb37bb-c8c3-45a0-973c-e3fa31982f8e.html,,inhalation,LC50,431 mg/m3,adverse effect observed, "Formaldehyde, oligomeric reaction products with phenol",9003-35-4," Repeated dose toxicity: Oral Data available for structurally and functionally similar read across chemicals was reviewed to determine the toxic nature of Formaldehyde, oligomeric reaction products with phenol. The studies are as mentioned below: Chronic toxicity oral study for the 50 -60% structurally and functionally similar read across test compounds were studied in male and female Osborne-Mendel rats. The test compounds was fed through the diet at a concentration of 0, 5000, 10000 or 20000 ppm (0, 250, 500 or 1000 mg/Kg bw) for 2 years. The animals were observed weekly for weight, food intake and general condition. Haematological examinations were made at termination. These examinations included white cell counts, red cell counts, haemoglobins and haematocrits. No effects were noted in the treated animals at the mentioned dose level. Based on the observations made, the no observed Adverse Effect Level (NOAEL) for the two test chemicals using Osborne-Mendel rats for a duration of 1 year is considered to be 1000 mg/Kg bw. Based on the data available for the read across test chemicals, Formaldehyde, oligomeric reaction products with phenol is not likely to be toxic as per the critera mentioned in CLP regulaion. Repeated dose toxicity: Inhalation Formaldehyde, oligomeric reaction products with phenol has very low vapor pressure of 3.186 Pa ( 0.0239 mmHg). Also, the test chemical has a particle size distribution of 53-150 micron, so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated dose toxicity by inhalation route is considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value for Formaldehyde, oligomeric reaction products with phenol (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not irritating to the skin. Based on these considerations, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93744822-643f-4f07-a4bb-33f03659768c/documents/247c1a08-1d75-414a-87cc-7547d565cc57_ef3b1bc1-8605-42cd-b4dd-2f1a8209fb2b.html,,,,,, "Formaldehyde, oligomeric reaction products with phenol",9003-35-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93744822-643f-4f07-a4bb-33f03659768c/documents/247c1a08-1d75-414a-87cc-7547d565cc57_ef3b1bc1-8605-42cd-b4dd-2f1a8209fb2b.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Formaldehyde, oligomeric reaction products with phenol",9003-35-4," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is >5000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute Inhalation toxicity dose (LC50) was considered based on different studies conducted on rats and mice for the test chemical. The studies concluded that the LC50 value is >5 mg/L (>5000 mg/m3), for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute inhalation toxicity. Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that the LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93744822-643f-4f07-a4bb-33f03659768c/documents/99854ee9-c22f-434a-a314-cdd08c85871f_ef3b1bc1-8605-42cd-b4dd-2f1a8209fb2b.html,,,,,, "Formaldehyde, oligomeric reaction products with phenol",9003-35-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93744822-643f-4f07-a4bb-33f03659768c/documents/99854ee9-c22f-434a-a314-cdd08c85871f_ef3b1bc1-8605-42cd-b4dd-2f1a8209fb2b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Formaldehyde, oligomeric reaction products with phenol",9003-35-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93744822-643f-4f07-a4bb-33f03659768c/documents/99854ee9-c22f-434a-a314-cdd08c85871f_ef3b1bc1-8605-42cd-b4dd-2f1a8209fb2b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Formaldehyde, oligomeric reaction products with phenol",9003-35-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93744822-643f-4f07-a4bb-33f03659768c/documents/99854ee9-c22f-434a-a314-cdd08c85871f_ef3b1bc1-8605-42cd-b4dd-2f1a8209fb2b.html,,inhalation,LC50,"7,570 mg/m3",no adverse effect observed, "Formaldehyde, polymer with benzenamine, hydrogenated",135108-88-2,"Formaldehyde, polymer with benzenamine, hydrogenated (MPCA) is corrosive to skin and is a viscous, high boiling, low VP material therefore a repeat dose oral study was conducted to assess the effects of repeated administration. Effects on the kidney were observed from repeated oral exposure. There were no treatment-related effects at the low dose of 15 mg/kg/day and this dosage therefore represents the no-observed-effect level (NOAEL) in the rat for MPCA when administered orally for at least 28 days. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/95bf92e8-799a-462d-bd5e-7ff8af7558b5/documents/7b9725c4-ef23-47ea-85d6-bbad31d347f9_2f0aedcd-ea4e-4a23-b97a-52bcb71f9aa8.html,,,,,, "Formaldehyde, polymer with benzenamine, hydrogenated",135108-88-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/95bf92e8-799a-462d-bd5e-7ff8af7558b5/documents/7b9725c4-ef23-47ea-85d6-bbad31d347f9_2f0aedcd-ea4e-4a23-b97a-52bcb71f9aa8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "Formaldehyde, polymer with benzenamine, hydrogenated",135108-88-2," Based on the key study, the oral LD50 of the test substance in rats is > 50 - 300 mg/kg (Evonik_Stockhausen, 2005). The dermal LD50 in rabbits is >700 mg/kg (no deaths were observed, but necrotic skin and severe edema was noted in males and females).  Testing for dermal toxicity at higher doses is not warranted as the material is corrosive to the skin. No data is available regarding acute inhalation toxicity. A data waiver is claimed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95bf92e8-799a-462d-bd5e-7ff8af7558b5/documents/b574d4f7-7862-48b9-822d-81dae672bed9_2f0aedcd-ea4e-4a23-b97a-52bcb71f9aa8.html,,,,,, "Formaldehyde, polymer with benzenamine, hydrogenated",135108-88-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95bf92e8-799a-462d-bd5e-7ff8af7558b5/documents/b574d4f7-7862-48b9-822d-81dae672bed9_2f0aedcd-ea4e-4a23-b97a-52bcb71f9aa8.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, "Formaldehyde, polymer with benzenamine, hydrogenated",135108-88-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95bf92e8-799a-462d-bd5e-7ff8af7558b5/documents/b574d4f7-7862-48b9-822d-81dae672bed9_2f0aedcd-ea4e-4a23-b97a-52bcb71f9aa8.html,,dermal,discriminating dose,700 mg/kg bw,no adverse effect observed, "Benzotriazol, ar-methyl-, reaction product with formaldehyde and Diethanolamine",1474044-75-1," A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422) performed with the read across candidate revealed parental toxicity at 150 mg/kg bw (clinical signs, reduced body weight gains with lower food consumption, slightly reduced thymus organ weight, and microscopic findings in the thymus and spleen). The NOAEL was considered to be 45 mg/kg body weight per day (WIL Research, 2013) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4193ff85-c226-4ea7-9dde-c5f5a57ee753/documents/IUC5-8ea2f237-772a-475b-9af7-322407e5a289_86b0dfd9-7c64-4a38-9dab-33cf2e4063d7.html,,,,,, "Benzotriazol, ar-methyl-, reaction product with formaldehyde and Diethanolamine",1474044-75-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4193ff85-c226-4ea7-9dde-c5f5a57ee753/documents/IUC5-8ea2f237-772a-475b-9af7-322407e5a289_86b0dfd9-7c64-4a38-9dab-33cf2e4063d7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,45 mg/kg bw/day,,rat "Benzotriazol, ar-methyl-, reaction product with formaldehyde and Diethanolamine",1474044-75-1," - LD50 acute oral toxicity (male and female; rat) = 1472 mg/kg bw (Ciba-Geigy Ltd, 1981) - LD50 acute dermal toxicity (male and female; rat) > 2000 mg/kg (Read across subtance) (Bioassay, 2012) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4193ff85-c226-4ea7-9dde-c5f5a57ee753/documents/IUC5-fa8e1fc0-4641-48d9-9966-967490fabf8e_86b0dfd9-7c64-4a38-9dab-33cf2e4063d7.html,,,,,, "Formaldehyde, reaction products with ethylenediamine",84066-92-2," On the basis of this 28-Day Repeated Dose Oral Toxicity study with formaldehyde, reaction products with ethylenediamine in male and female Wistar rats with dose levels of 100, 300, and 800 mg/kg body weight day, the following conclusions can be made: At 800 mg/kg BW increased clinical symptoms were found which indicate discomfort of the animals. Furthermore, decreased thymus weight as well as increased adrenal weight indicates stress of the animals, too. An additional tissue besides the stomach occurred probably due to the local irritant effect of the test item. Pathologically, test item-related lesions of toxicological significance were seen in the kidney and comprised mild or moderate tubular degeneration/regeneration at the inner cortex in all rats treated at 800 mg/kg/day. Hence, the dosage of 800 mg/kg BW is assumed to induce adverse effects within this study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f01978de-cc35-4360-94ed-3ed34b18861d/documents/IUC5-4a43942c-1687-456a-8024-192802811fb6_883738ea-d696-4506-9a67-127b647974e0.html,,,,,, "Formaldehyde, reaction products with ethylenediamine",84066-92-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f01978de-cc35-4360-94ed-3ed34b18861d/documents/IUC5-4a43942c-1687-456a-8024-192802811fb6_883738ea-d696-4506-9a67-127b647974e0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Formaldehyde, reaction products with ethylenediamine",84066-92-2," Acute toxicity studies with rats are available for the oral, dermal and inhalation routes of exposure. The ATE is 500 mg/kg oral and > 2,000 mg/kg bw for the dermal route. The LC50 for the inhalation route is in the range between 1.04 - 5.12 mg/L. Oral exposure appears to lead to more significant toxicity than exposure by dermal or inhalation routes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f01978de-cc35-4360-94ed-3ed34b18861d/documents/IUC5-3f0a9d40-7945-4f5f-a265-90e694989e49_883738ea-d696-4506-9a67-127b647974e0.html,,,,,, "Formaldehyde, reaction products with ethylenediamine",84066-92-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f01978de-cc35-4360-94ed-3ed34b18861d/documents/IUC5-3f0a9d40-7945-4f5f-a265-90e694989e49_883738ea-d696-4506-9a67-127b647974e0.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, "Formaldehyde, reaction products with ethylenediamine",84066-92-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f01978de-cc35-4360-94ed-3ed34b18861d/documents/IUC5-3f0a9d40-7945-4f5f-a265-90e694989e49_883738ea-d696-4506-9a67-127b647974e0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Formaldehyde, reaction products with m-phenylenediamine, sodium sulfide (Na2S) and sulfur",70892-34-1,"No parental systemic effects were observed up to the highest dose level tested (1000 mg/kg) in a subacute reproduction screening study according to OECD 422. The NOAEL was >1000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 1 reliable without restriction ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc326f09-d7f9-4e2d-bc30-2ae7bf7ae500/documents/IUC5-cf5ea25d-6c97-4aa7-93d0-6800cc3eacfd_beeb1f48-7a72-49aa-b5af-9c4f995bdbea.html,,,,,, "Formaldehyde, reaction products with m-phenylenediamine, sodium sulfide (Na2S) and sulfur",70892-34-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc326f09-d7f9-4e2d-bc30-2ae7bf7ae500/documents/IUC5-cf5ea25d-6c97-4aa7-93d0-6800cc3eacfd_beeb1f48-7a72-49aa-b5af-9c4f995bdbea.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Formaldehyde, reaction products with m-phenylenediamine, sodium sulfide (Na2S) and sulfur",70892-34-1,"Acute toxicity: via oral route: LD50 >2000 mg/kg bw/d in rats (OECD 423) Acute toxicity: via dermal route: LD50 >2000 mg/kg bw/d in rats (OECD 402) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 1; recent guideline under GLP Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch 1; recent guideline under GLP ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc326f09-d7f9-4e2d-bc30-2ae7bf7ae500/documents/IUC5-1435eccb-c635-4613-9ede-a1c65cc87583_beeb1f48-7a72-49aa-b5af-9c4f995bdbea.html,,,,,, "Formaldehyde, reaction products with m-phenylenediamine, sodium sulfide (Na2S) and sulfur",70892-34-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc326f09-d7f9-4e2d-bc30-2ae7bf7ae500/documents/IUC5-1435eccb-c635-4613-9ede-a1c65cc87583_beeb1f48-7a72-49aa-b5af-9c4f995bdbea.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Formaldehyde, reaction products with m-phenylenediamine, sodium sulfide (Na2S) and sulfur",70892-34-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc326f09-d7f9-4e2d-bc30-2ae7bf7ae500/documents/IUC5-1435eccb-c635-4613-9ede-a1c65cc87583_beeb1f48-7a72-49aa-b5af-9c4f995bdbea.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides",83968-28-9,"OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) was performed to determine the toxic nature of the test compound C.I. Basic Violet 1 (CAS no 8004 -87 -3) upon repeated exposure to Crl:CD (SD) strain rats. The test chemical was dosed at levels of 0, 1.6, 8 or 40 mg/Kg bw (Actual ingested dose). Male rats were treated for 42 days and female rats were treated from 41 - 48 days (from 14 days before mating to day 4 of lactation). Based on the effects noted at 40 mg/Kg bw, the No Observed Adverse Effect Level (NOAEL) for the test compound C.I. Basic Violet 1 is likely to be 8 mg/Kg bw. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/841e2e37-c7c8-48ee-87c9-bc368f34b511/documents/IUC5-53bd8a09-f0a7-4862-9fad-d801e2c462a7_b25fc035-79e0-4c53-aa08-92f1cb88667c.html,,,,,, "Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides",83968-28-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/841e2e37-c7c8-48ee-87c9-bc368f34b511/documents/IUC5-53bd8a09-f0a7-4862-9fad-d801e2c462a7_b25fc035-79e0-4c53-aa08-92f1cb88667c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,8 mg/kg bw/day,,rat "Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides",83968-28-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/841e2e37-c7c8-48ee-87c9-bc368f34b511/documents/IUC5-53bd8a09-f0a7-4862-9fad-d801e2c462a7_b25fc035-79e0-4c53-aa08-92f1cb88667c.html,Chronic toxicity – systemic effects,inhalation,LOAEC,0.3 mg/m3,,rat "Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides",83968-28-9,LD50 was considered to be > 300 mg/kg bw when Crl:CD SD female rats were treated with C.I. Basic Violet 1 orally by gavage in 0.5 w/v% Methylcellulose aqueous solution. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/841e2e37-c7c8-48ee-87c9-bc368f34b511/documents/IUC5-f6f933d3-70c1-4966-898c-73f1dbbf206f_b25fc035-79e0-4c53-aa08-92f1cb88667c.html,,,,,, "Formaldehyde, reaction products with N,N-dimethylbenzenamine and N-methylbenzenamine, oxidized, hydrochlorides",83968-28-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/841e2e37-c7c8-48ee-87c9-bc368f34b511/documents/IUC5-f6f933d3-70c1-4966-898c-73f1dbbf206f_b25fc035-79e0-4c53-aa08-92f1cb88667c.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "Reaction product of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and phenol, heptyl derivs.",1471311-26-8,"Under the conditions of this screening study, the NOAEL for systemic toxicity was 100 mg/kg/day based on effects on organ weights (lower thymus gland weights at ≥200 mg/kg/day, lower spleen and heart weights at ≥ 500 mg/kg/day, lower brain weight at 1000 mg/kg/day, and higher liver and thyroid gland weights at ≥500 mg/kg/day) and the presence of test item-related microscopic findings at ≥200 mg/kg/day. The microscopic findings were still present at the post-treatment phase necropsy, however, at lesser severity.The NOAEL of 100 mg/kg bw/day as suggested by the Study Director is based on minor and reversible effects on organ weights and microscopic findings at 200 mg/kg bw/day whereas more significant toxic effects were noted at 500 and 1000 mg/kg bw/day. Consequently it is considered more appropriate to propose a LOAEL of 500 mg/kg bw/day, a NOAEL of 200 mg/kg bw/day and 100 mg/kg bw/day as the NOELfor systemic toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34419f3d-031d-4861-ae76-3fc4a73b8b45/documents/1d8a9440-763d-4a41-a7ab-d6d3900c2067_656bfac4-ba75-4483-822c-d7e305950283.html,,,,,, "Reaction product of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and phenol, heptyl derivs.",1471311-26-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34419f3d-031d-4861-ae76-3fc4a73b8b45/documents/1d8a9440-763d-4a41-a7ab-d6d3900c2067_656bfac4-ba75-4483-822c-d7e305950283.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Reaction product of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and phenol, heptyl derivs.",1471311-26-8,Oral: The acute oral median lethal dose (LD50) of the test item in the Sprague Dawley strain rat was found to be greater than 2000 mg/kg bodyweightDermal: The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight.Inhalation: There will be no exposure to the test material via the inhalation route ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34419f3d-031d-4861-ae76-3fc4a73b8b45/documents/d29233e0-6296-473b-a606-9df215a76613_656bfac4-ba75-4483-822c-d7e305950283.html,,,,,, "Formaldehyde, telomer with 1,3-benzenedimethanamine, 1,3-benzenediol and ethenylbenzene",710292-85-6,"A 28-day repeated dose toxicity study in rats was undertaken with HK 128 at doses of 100, 300 and 1000 mg/kg bw. The NOAEL for adult toxicity is set at 100 mg/kg bw/d based on an increased incidence and severity of macrophage foci at 300 and 1000 mg/kg bw/d with concurrent increased incidence and severity of necrosis of the mesenteric lymph node at 1000 mg/kg bw/d. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/101d4ae9-7697-428c-aed1-da5bb9ca6b85/documents/IUC5-653868ac-aaa3-4b61-ad3d-918cdc8fe2e1_04287d66-25a2-4631-bb8f-ea8c331de93d.html,,,,,, "Formaldehyde, telomer with 1,3-benzenedimethanamine, 1,3-benzenediol and ethenylbenzene",710292-85-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/101d4ae9-7697-428c-aed1-da5bb9ca6b85/documents/IUC5-653868ac-aaa3-4b61-ad3d-918cdc8fe2e1_04287d66-25a2-4631-bb8f-ea8c331de93d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Formaldehyde, telomer with 1,3-benzenedimethanamine, 1,3-benzenediol and ethenylbenzene",710292-85-6,The LD50 value for acute oral toxicity is greater than 2000 mg/kg bw in rats. The LD50 value for acute dermal toxicity is greater than 2000 mg/kg bw in rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/101d4ae9-7697-428c-aed1-da5bb9ca6b85/documents/IUC5-29d75506-792e-4df6-945a-eebd3b568e13_04287d66-25a2-4631-bb8f-ea8c331de93d.html,,,,,, "Formaldehyde, telomer with 1,3-benzenedimethanamine, 1,3-benzenediol and ethenylbenzene",710292-85-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/101d4ae9-7697-428c-aed1-da5bb9ca6b85/documents/IUC5-29d75506-792e-4df6-945a-eebd3b568e13_04287d66-25a2-4631-bb8f-ea8c331de93d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Formaldehyde, telomer with 1,3-benzenedimethanamine, 1,3-benzenediol and ethenylbenzene",710292-85-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/101d4ae9-7697-428c-aed1-da5bb9ca6b85/documents/IUC5-29d75506-792e-4df6-945a-eebd3b568e13_04287d66-25a2-4631-bb8f-ea8c331de93d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Formamide, N,N'-1,4-phenylenebis-, reaction products with 4-methyl-1,3-benzenediamine and sulfur, leuco derivatives",71838-68-1, In an acute oral toxicity study in rats the acute oral LD50 was determined to be > 2000 mg/kg bw (corresponding to > 2660 mg product/kg bw). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32a0bbb4-8690-435f-8c39-c66e51327b9d/documents/d5ddf08d-74a5-4cc2-ab8c-6531c8045375_04c31223-5e3e-4adf-94d7-ac975e249dbc.html,,,,,, "Formamide, N,N'-1,4-phenylenebis-, reaction products with 4-methyl-1,3-benzenediamine and sulfur, leuco derivatives",71838-68-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32a0bbb4-8690-435f-8c39-c66e51327b9d/documents/d5ddf08d-74a5-4cc2-ab8c-6531c8045375_04c31223-5e3e-4adf-94d7-ac975e249dbc.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Formic acid, manufacture of, by-products from",2137881-70-8," Due to its corrosive properties, the local effects of formic acid prevail over systemic effects following exposures via all routes; no signs of systemic toxicity have been observed in sub-chronic and chronic studies using formate salts. Propylidynetrimethanol and pentaerythritol are of low toxicity following repeated dose, showing only unspecific effects of limited toxicological significance. The primary effect following repeated exposures to the reaction mass of 2,2-bis(formyloxymethyl)propane-1,3-diyl diformate and formic acid is local, site of contact toxicity due to the caustic properties of formic acid.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab1d88f2-a674-4f33-803d-c0f0d8a2cc31/documents/c5386125-26bc-4d32-a378-f8816553a048_daa296ab-4dd5-457a-831a-684764bbdd77.html,,,,,, "Formic acid, manufacture of, by-products from",2137881-70-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab1d88f2-a674-4f33-803d-c0f0d8a2cc31/documents/c5386125-26bc-4d32-a378-f8816553a048_daa296ab-4dd5-457a-831a-684764bbdd77.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,67 mg/kg bw/day,,rat "Formic acid, manufacture of, by-products from",2137881-70-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab1d88f2-a674-4f33-803d-c0f0d8a2cc31/documents/c5386125-26bc-4d32-a378-f8816553a048_daa296ab-4dd5-457a-831a-684764bbdd77.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,122 mg/m3,,rat "Formic acid, manufacture of, by-products from",2137881-70-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab1d88f2-a674-4f33-803d-c0f0d8a2cc31/documents/c5386125-26bc-4d32-a378-f8816553a048_daa296ab-4dd5-457a-831a-684764bbdd77.html,Repeated dose toxicity – local effects,inhalation,NOAEC,62 mg/m3,adverse effect observed,mouse "Formic acid, manufacture of, by-products from",2137881-70-8," Guideline studies on the acute oral toxicity (OECD Test Guideline 401) and on the inhalation toxicity (OECD Test Guideline 403) of formic acid in the rat are available. In accordance with test guidelines, the dermal toxicity was not examined because of the corrosive properties of formic acid. Pentaerythritol and propylidynetrimethanol are demonstrated to be of very low acute toxicity by all routes investigated. Similar low acute toxicity is predicted for their respective esters. The acute toxicity of the reaction mass of 2,2 -bis(formyloxymethyl) propane-1,3-diyl diformate and formic acid is therefore driven by the main component: formic acid ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab1d88f2-a674-4f33-803d-c0f0d8a2cc31/documents/f00b7824-2978-4b0d-a6c8-d16d6dc8233e_daa296ab-4dd5-457a-831a-684764bbdd77.html,,,,,, "Formic acid, manufacture of, by-products from",2137881-70-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab1d88f2-a674-4f33-803d-c0f0d8a2cc31/documents/f00b7824-2978-4b0d-a6c8-d16d6dc8233e_daa296ab-4dd5-457a-831a-684764bbdd77.html,,oral,LD50,"1,237 mg/kg bw",adverse effect observed, "Formic acid, manufacture of, by-products from",2137881-70-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab1d88f2-a674-4f33-803d-c0f0d8a2cc31/documents/f00b7824-2978-4b0d-a6c8-d16d6dc8233e_daa296ab-4dd5-457a-831a-684764bbdd77.html,,inhalation,LC50,12.4 mg/m3,adverse effect observed, "Frits, chemicals",65997-18-4," Value used for CSA: NOAEL (oral, systemic, animal data): 2.2 mg Ni/kg bw/day read-across from Ni sulphate hexahydrate (Heim et al 2007) LOAEC (inhalation, local, animal data): 0.5 mg Ni/m3 (Dunnick et al, 1995) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/99e982e8-2265-4d54-95e2-50916a4e8e49/documents/b51a4412-a7e8-4ccc-8004-d045bb0bed74_77015bd8-13cd-4e27-831d-979b966a7e12.html,,,,,, "Frits, chemicals",65997-18-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/99e982e8-2265-4d54-95e2-50916a4e8e49/documents/b51a4412-a7e8-4ccc-8004-d045bb0bed74_77015bd8-13cd-4e27-831d-979b966a7e12.html,Chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "Frits, chemicals",65997-18-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/99e982e8-2265-4d54-95e2-50916a4e8e49/documents/b51a4412-a7e8-4ccc-8004-d045bb0bed74_77015bd8-13cd-4e27-831d-979b966a7e12.html,Chronic toxicity – systemic effects,inhalation,LOAEC,0.5 mg/m3,,rat "Frits, chemicals",65997-18-4," Value used for CSA: NOAEL (oral, systemic, animal data): >11,000 mg/kg for nickel oxide green (>8,500 mg Ni/kg/day) (EPSL, 2008)       9,990 mg/kg for nickel oxide black (6,200 mg Ni/kg/day) (EPSL, 2009) NOAEL (oral, systemic, human data): 0.012 mg Ni (Ni ion)/kg bw/day; based on exacerbated existing dermatitis (Nielsen et al., 1999) NOAEC (inhalation, systemic, animal data): >5.08 mg/L for nickel oxide green; >5.15 mg/L for nickel oxide black (>3,900 mg Ni/m3) (EPSL, 2009/2010) NOAEC (inhalation, local, animal data): 3.9 mg Ni/m3 (MMAD =2.9 µm) for local effects (DNEL calculation is based on 16-day repeated dose study-Dunnick et al, 1988; no acute, local effects data available) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99e982e8-2265-4d54-95e2-50916a4e8e49/documents/706e5aad-dff1-4573-8577-d258475e13b4_77015bd8-13cd-4e27-831d-979b966a7e12.html,,,,,, "Fructofuranosidase, β-",9001-57-4," Sub-chronic Toxicity (OECD 408), oral, rat: NOAEL: 6400 mg/kg bw/day Read-across from the source substance: Endoxylanase (CAS 9025 -57 -4) Sub-chronic Toxicity (OECD 408), oral, rat: NOAEL: 1000 mg/kg bw/day Read-across from the source substance: Alpha-amylase (CAS: 9000 -90 -2) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26d6252a-3108-4d5d-974a-ac3e9f42555c/documents/60cb166f-bec7-4cef-aa3c-7c203ffa5f7d_f5a13f2d-4707-490d-b3bf-991e5a3d9e9e.html,,,,,, "Fructofuranosidase, β-",9001-57-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26d6252a-3108-4d5d-974a-ac3e9f42555c/documents/60cb166f-bec7-4cef-aa3c-7c203ffa5f7d_f5a13f2d-4707-490d-b3bf-991e5a3d9e9e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"6,400 mg/kg bw/day",,rat "Fructofuranosidase, β-",9001-57-4," Acute oral toxicity study (OECD 401), male and female rat: LD50 > 2000 mg/kg bw Read-across from the source substance: endoxylanase (CAS 9025 -57 -4) Acute inhalation toxicity study (OECD 403), male and female rat: LC50 > 5.13 mg/L air Read-across from the source substance: endoxylanase (CAS 9025 -57 -4) Acute toxicity via dermal route is waived based on exposure considerations and the known properties of the substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26d6252a-3108-4d5d-974a-ac3e9f42555c/documents/9108e97a-4861-430b-8589-11242dc340f6_f5a13f2d-4707-490d-b3bf-991e5a3d9e9e.html,,,,,, "Fuel gases, refinery",68308-27-0," Only one stream (Liquified Petroleum Gases CAS 68476 -85 -7) of the Other Petroleum Gases category has been tested but this and the main constituents of the category (C1-C4 alkanes and propene) indicate low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration on the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. Propene has also been thoroughly tested for repeated exposure toxicity up to very high exposure concentrations in sub-chronic and chronic studies. Overall, only minimal local irritation effects to the nasal cavity (mild rhinitis) were observed and only following chronic lifetime exposure to high doses in rats and mice. After repeated dose exposure via oral or inhalation routes, benzene causes adverse effects on the haematopoietic system of animals and humans. The mammalian toxicity effects of this category will be driven by the content of benzene if the latter is present at levels of >10%. Additionally, the category may contain carbon monoxide which could trigger classification. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3c2f997-f058-4d1b-b0c9-570c493fb042/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_b312d74f-527a-4662-83bd-1fe1f05671b0.html,,,,,, "Fuel gases, refinery",68308-27-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3c2f997-f058-4d1b-b0c9-570c493fb042/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_b312d74f-527a-4662-83bd-1fe1f05671b0.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"7,214 mg/m3",,rat "Fuel gases, refinery",68308-27-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3c2f997-f058-4d1b-b0c9-570c493fb042/documents/IUC5-236894c5-98e3-4184-9f10-976f79231ade_b312d74f-527a-4662-83bd-1fe1f05671b0.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"8,600 mg/m3",adverse effect observed,rat "Fuel gases, refinery",68308-27-0," Members of the Other Petroleum Gases category are all flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams within the Other Petroleum Gases category but data are available on the constituents. Across species, main constituent gases in this category (C1-C4 alkanes and propene) show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-2.4%, circa 34,000 – 42,000 mg/m3. The mammalian toxicity effects of this category will be not driven by the content of benzene in streams where it is present at levels of <1%. However, some streams in this category may contain benzene levels >1% or carbon monoxide which could trigger classification. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3c2f997-f058-4d1b-b0c9-570c493fb042/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_b312d74f-527a-4662-83bd-1fe1f05671b0.html,,,,,, "Fuel gases, refinery",68308-27-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3c2f997-f058-4d1b-b0c9-570c493fb042/documents/IUC5-e8f00e64-c9ee-4cf4-8ed1-de172e050185_b312d74f-527a-4662-83bd-1fe1f05671b0.html,,inhalation,LC50,"22,948 mg/m3",no adverse effect observed, "Fumes, silica",69012-64-2,"Repeated dose inhalation toxicity studies with synthetic amorphous silica by Reuzel et al. (1991), Groth et al. (1981) and Artz et al. (2007) show mainly reversible lung effects. Human information on the silicon/ferrosilicon/synthetic amorphous silica manufacturing industry shows only effects attributable to general dust exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7d3d88d-4bde-4693-a599-0878d477b79c/documents/IUC5-c6597d12-fa9a-4f80-b3d8-e00cb65804c9_70ae54a1-249d-4341-b9f3-b114aada018a.html,,,,,, "Fumes, silica",69012-64-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7d3d88d-4bde-4693-a599-0878d477b79c/documents/IUC5-c6597d12-fa9a-4f80-b3d8-e00cb65804c9_70ae54a1-249d-4341-b9f3-b114aada018a.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1.3 mg/m3,adverse effect observed,rat "Fumes, silica",69012-64-2,"Animal data on the acute toxicity of synthetic amorphous silica, which have been used for read-across, do not show acute oral, inhalation or dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7d3d88d-4bde-4693-a599-0878d477b79c/documents/IUC5-258e0b6a-9b3d-4c8e-ae9c-652ca96bd3e6_70ae54a1-249d-4341-b9f3-b114aada018a.html,,,,,, "Furan-2,5-dicarboxylic acid",3238-40-2,"In a 90-day oral toxicity study with rats no toxicologically relevant effects up to and including the highest dose tested were observed, and therfore the NOAEL for FDCA is at least 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/240236cb-842a-45ec-967b-6ac0438b7b1a/documents/90545f76-0c90-422a-8ab3-37f415d733e6_05232a0c-939c-4171-a3cc-14dd71c4bacb.html,,,,,, "Furan-2,5-dicarboxylic acid",3238-40-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/240236cb-842a-45ec-967b-6ac0438b7b1a/documents/90545f76-0c90-422a-8ab3-37f415d733e6_05232a0c-939c-4171-a3cc-14dd71c4bacb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat "Furan-2,5-dicarboxylic acid",3238-40-2,"In an acute oral toxicity study with rats, performed according to OECD 423 test guidelines, an LD50 >2000 mg/kg bw was determined.In an acute dermal toxicity study with rats, performed according to OECD 402 test guideline and GLP principles, an LD50 >2000 mg/kg bw was determined. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/240236cb-842a-45ec-967b-6ac0438b7b1a/documents/9cfdcdf2-9a1b-462f-803a-77a708714dc5_05232a0c-939c-4171-a3cc-14dd71c4bacb.html,,,,,, "Furan-2,5-dicarboxylic acid",3238-40-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/240236cb-842a-45ec-967b-6ac0438b7b1a/documents/9cfdcdf2-9a1b-462f-803a-77a708714dc5_05232a0c-939c-4171-a3cc-14dd71c4bacb.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Furan-2,5-dicarboxylic acid",3238-40-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/240236cb-842a-45ec-967b-6ac0438b7b1a/documents/9cfdcdf2-9a1b-462f-803a-77a708714dc5_05232a0c-939c-4171-a3cc-14dd71c4bacb.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Fusanus spicatus, ext.",92875-02-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad3dc8ae-e709-49be-bd4f-a1f57ea8c6f5/documents/d4df4655-ea43-4fdd-aee3-72070ffb8e58_51df3c30-b3a3-4fac-b1ff-c1b57437f1ad.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Fusidic acid,6990-06-3," In a subchronic 5 months oral toxicity study in rats, fusidic acid was suspended in a saccharose solution and administered orally by gavage to one group of 25 male + 25 female rats. Daily doses of 400 mg/kg bw were administered six days a week for 5 months. A control group of 10 male + 10 female rats was treated with the sugar solution. No haematological changes and no manifestations of toxicity were apparent throughout the test period. No gross pathological changes were detected. Microscopic examination of lung, heart, spleen, liver, kidney, stomach and intestine did not disclose any morphological alterations that could be attributed to fusidic acid. Based on these observations, a NOAEL of 400 mg/kg bw/d could be established. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b24a53ae-a7e0-45de-8fb9-5bedc2224214/documents/d32ef882-3cba-47c9-a6da-96dc9834f543_e703ce84-180d-42d5-a7e4-95432430a96b.html,,,,,, Fusidic acid,6990-06-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b24a53ae-a7e0-45de-8fb9-5bedc2224214/documents/d32ef882-3cba-47c9-a6da-96dc9834f543_e703ce84-180d-42d5-a7e4-95432430a96b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat Fusidic acid,6990-06-3," Acute toxicity (oral): - Oral (gavage) administration of fusidic acid or spiked fusidic acid at 2000 mg/kg/day to female mice of the Crl:CD1(ICR) strain for 15 days was well tolerated and fusidic acid and spiked fusidic acid can be considered comparable in terms of their toxicological potential to mice. Based on the results from this study, an LD50 > 2000 mg/kg bw/d could be established. - A dose level of up to 2000 mg/kg/day of fusidic acid given orally by gavage for 7 days were well tolerated in mice in this study. Based on the results from this study, an LD50 > 2000 mg/kg bw/d could be established. Acute toxicity (dermal): - In a cutaneous absorption study using 8 rabbits, 1g of 2% triated fusidin in fusidin salve (without lanolin) corresponding to 6.4-10 mg/kg bw was applied to the rabbit skin. 4 rabbits were treated with sodium lauryl sulphate in vaseline (to damage skin) / 4 served as control and were not treated (undamaged skin). 24 h later all animals were treated with fusidin salve (1g) and after 0, 2, 4,6, 8,24 and 48 h blood samples were taken. Absorption was measured in serum samples. This test method is comparable to recognised guideline for acute dermal toxicity testing in terms of application. Based on the results form the cutaneous absorption study using up to 10 mg/kg bw, an LD50 for dermal toxicity can be established to > 10 mg/kg bw.       Acute toxicity (inhalation): - No data available Acute toxicity (other routes): - Acute toxicity of fusidic acid was determined for intraperitoneal administration to mice and rats. LD50 values were determined to be > 3900 mg/kg bw (3111-4440) for mice and > 3550 mg/kg bw (2554-4934) for rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b24a53ae-a7e0-45de-8fb9-5bedc2224214/documents/d899d093-d014-4d16-b7ab-af594474f863_e703ce84-180d-42d5-a7e4-95432430a96b.html,,,,,, Fusidic acid,6990-06-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b24a53ae-a7e0-45de-8fb9-5bedc2224214/documents/d899d093-d014-4d16-b7ab-af594474f863_e703ce84-180d-42d5-a7e4-95432430a96b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Fusidic acid,6990-06-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b24a53ae-a7e0-45de-8fb9-5bedc2224214/documents/d899d093-d014-4d16-b7ab-af594474f863_e703ce84-180d-42d5-a7e4-95432430a96b.html,,dermal,LD50,10 mg/kg bw,no adverse effect observed, Gadolinium,7440-54-2," Oral Under the conditions of the study, the oral LD50 value in female Wistar rats was established to exceed 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fe8146a-1b51-4c8f-b73b-f0ece44e232d/documents/a62cb44e-8bf6-4d41-996e-010e740b5506_5d1b67d8-d786-4707-b70e-0e43d4488178.html,,,,,, Gadolinium,7440-54-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fe8146a-1b51-4c8f-b73b-f0ece44e232d/documents/a62cb44e-8bf6-4d41-996e-010e740b5506_5d1b67d8-d786-4707-b70e-0e43d4488178.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gadolinium oxide sulfide (Gd2O2S), praseodymium-doped",68609-42-7,GOS was tested for acute oral toxicity. no mortality was observed. GOS is not toxic according to CLP-criteria ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccdfaffa-3334-43bf-a6d1-ddf23383a5bd/documents/4cd662d1-07d9-4caf-9a4e-bde19c63b425_d8813cf2-aba8-45d5-8183-7ba69d81d752.html,,,,,, "Gadolinium oxide sulfide (Gd2O2S), praseodymium-doped",68609-42-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccdfaffa-3334-43bf-a6d1-ddf23383a5bd/documents/4cd662d1-07d9-4caf-9a4e-bde19c63b425_d8813cf2-aba8-45d5-8183-7ba69d81d752.html,,oral,LD50,"> 2,000 mg/kg bw",adverse effect observed, Gadolinium zirconium oxide,11073-79-3," In an acute oral toxicity study (according to OECD 423), two groups, each of three female Wistar rats, were treated with the test item suspended in corn oil by oral gavage administration at a dosage of 2000 mg/kg body weight and were observed for 14 days. No test-item related signs of toxicity were seen during observation nor necropsy. Based on these results the oral LD50was determined to be greater than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2667aa7b-9cd0-4efc-9db7-89cab3f7b58a/documents/c4250c40-c6af-4e39-8f71-d9bfbcf65090_ab286d23-9449-4e5d-ba92-8c63e5000df6.html,,,,,, Gadoliniumsulfite trihydrate,51285-81-5,300 mg/kg were considered to be the NOAEL (no observed adverse effect level) because the changes seen were considered to be reversible based on the histopathological results seen at 1000 mg/kg at the end of the recovery period. 1000 mg/kg were considered not to be tolerated by the rats due to slight deviations in the FOB and motor activity and histopathological findings which were not fully reversible at the end of the recovery period. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/251896f7-855b-4079-a285-a89a444eeebc/documents/5fa47bda-a8ce-4c10-9599-a23cd0cfbdf8_594a4d92-788c-43d9-ace3-540766b280b6.html,,,,,, Gadoliniumsulfite trihydrate,51285-81-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/251896f7-855b-4079-a285-a89a444eeebc/documents/5fa47bda-a8ce-4c10-9599-a23cd0cfbdf8_594a4d92-788c-43d9-ace3-540766b280b6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Gadoliniumsulfite trihydrate,51285-81-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/251896f7-855b-4079-a285-a89a444eeebc/documents/ebb8c82f-ef17-4eb6-ac71-f7157c2cdef8_594a4d92-788c-43d9-ace3-540766b280b6.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Gadoliniumsulfite trihydrate,51285-81-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/251896f7-855b-4079-a285-a89a444eeebc/documents/ebb8c82f-ef17-4eb6-ac71-f7157c2cdef8_594a4d92-788c-43d9-ace3-540766b280b6.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Gallium,7440-55-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4f080dc-a9cc-4d8f-aa07-49242ce72b03/documents/f7110dc3-1335-4c24-9f9c-727f504379da_1a6639be-2f8e-4130-a187-b71706938882.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Gallium trichloride,13450-90-3, The reported oral LD50 for rats is 4700 mg GaCl3/kg bw. Rats fed gallium trichloride at dietary levels of 500 or 10000 ppm gallium for 26 weeks exhibited no observable toxic symptoms. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5abf8096-6ee2-4268-aaec-4540db6bd23a/documents/6c0e7414-30f2-4fc1-9a7c-48f84100af6a_ea0466c5-7df0-44db-8092-b5754406b14a.html,,,,,, Gallium trichloride,13450-90-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5abf8096-6ee2-4268-aaec-4540db6bd23a/documents/6c0e7414-30f2-4fc1-9a7c-48f84100af6a_ea0466c5-7df0-44db-8092-b5754406b14a.html,,oral,LD50,"4,700 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), hydrodesulfurized light vacuum",64742-87-6," No repeat-dose toxicity studies were located for oral toxicity of VGOs/HGOs/Distillate fuels. However, supporting information is available, with two studies conducted on petroleum substances in other categories; a sub-chronic study on a Kerosine (CAS 8008-20-6) and a chronic study on a Highly Refined Base Oil (CAS 8042-47-5). These do not contain significant amounts of the PAH constituents considered to be the drivers of toxicological hazard for VHGO, but have other constituents in common. They help to demonstrate that no significant toxicological hazard is expected from other aliphatic (paraffinic and naphthenic) and aromatic (mono- and di- aromatic) constituents.   In addition, one oral sub-chronic study is proposed on a VHGO substance containing high levels of PAH constituents.   For sub-chronic inhalation toxicity of VGOs/HGOs/Distillate fuels, a conservative sub-chronic NOAEC of 750 mg/m3 was determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of >1710 mg/m3 was established for systemic effects, based on no significant findings at this level (OECD 413).   In a subacute dermal repeated-dose toxicity test, the NOEL level based on dermal irritation was 0.0001 mL/kg and a NOEL of 0.5 mL/kg was calculated for systemic toxicity (OECD 410). For subchronic dermal toxicity, a NOAEL of 30 mg/kg body weight/day appears appropriate for VGOs/HGOs/Distillate fuels based on changes in haematological parameters (decreased RBC, haemoglobin, HCT), clinical chemistry values (increased urea nitrogen and cholesterol) parameters and organ weight effects (increased liver weight, decreased thymus weight). The NOAEL for local effects is 125 mg/kg body weight/d, based on histopathological changes present at the application site (OECD 411). In addition, a recent study to OECD 411 and GLP was conducted on a member of the VHGO category. This showed low systemic toxicity (NOAEL 600 mg/kg/day), with higher doses not possible due to excessive local irritation. This study was conducted on a substance in the category low in PAH content (the constituent expected to drive toxicological hazard). ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/998f9fd6-1239-49e8-8767-245c114d4dd7/documents/6eb3217d-cfcb-4c55-a348-ca82d2c18ff0_da632266-c0b6-42f0-96a8-41fb4157e60e.html,,,,,, "Gas oils (petroleum), hydrodesulfurized light vacuum",64742-87-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/998f9fd6-1239-49e8-8767-245c114d4dd7/documents/6eb3217d-cfcb-4c55-a348-ca82d2c18ff0_da632266-c0b6-42f0-96a8-41fb4157e60e.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,30 mg/kg bw/day,,rat "Gas oils (petroleum), hydrodesulfurized light vacuum",64742-87-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/998f9fd6-1239-49e8-8767-245c114d4dd7/documents/6eb3217d-cfcb-4c55-a348-ca82d2c18ff0_da632266-c0b6-42f0-96a8-41fb4157e60e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Gas oils (petroleum), hydrodesulfurized light vacuum",64742-87-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/998f9fd6-1239-49e8-8767-245c114d4dd7/documents/6eb3217d-cfcb-4c55-a348-ca82d2c18ff0_da632266-c0b6-42f0-96a8-41fb4157e60e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Gas oils (petroleum), hydrodesulfurized light vacuum",64742-87-6," Acute Oral Toxicity: Acute oral toxicity of #2 home heating oil, was evaluated in male and female rats following a single oral gavage administration of the test material at different concentrations (similar to OECD 401).  The  LD50 for #2 home heating oil is 21.1 mL/kg body weight (approx 17,900 mg/kg). Based on all acute oral toxicity studies, the LD50 for VGOs/HGOs/Distillate fuels is > 5000 mg/kg bw. Acute Inhalation Toxicity: Acute inhalation toxicity of naval distillate in male and female rats was evaluated in a study involving whole-body exposure  for 4 hours (similar to OECD 403).  The acute inhalation LC50 was 4.1 mg/L . Acute Dermal Toxicity: In an acute dermal toxicity study, male and female New Zealand White rabbits were exposed to #2 home heating oil for 24 hours at a dose level of 5 mL/kg (approx 4300 mg/kg). The animals were then observed for 14 days (similar to OECD 402).  Based on this study, the acute dermal LD50 is > 4300 mg/kg.   ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/998f9fd6-1239-49e8-8767-245c114d4dd7/documents/50ca8717-e805-460b-bb99-b647882e2c88_da632266-c0b6-42f0-96a8-41fb4157e60e.html,,,,,, "Gas oils (petroleum), hydrodesulfurized light vacuum",64742-87-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/998f9fd6-1239-49e8-8767-245c114d4dd7/documents/50ca8717-e805-460b-bb99-b647882e2c88_da632266-c0b6-42f0-96a8-41fb4157e60e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), hydrodesulfurized light vacuum",64742-87-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/998f9fd6-1239-49e8-8767-245c114d4dd7/documents/50ca8717-e805-460b-bb99-b647882e2c88_da632266-c0b6-42f0-96a8-41fb4157e60e.html,,dermal,LD50,"4,300 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), hydrodesulfurized light vacuum",64742-87-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/998f9fd6-1239-49e8-8767-245c114d4dd7/documents/50ca8717-e805-460b-bb99-b647882e2c88_da632266-c0b6-42f0-96a8-41fb4157e60e.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "Gas oils (petroleum), hydrotreated light vacuum",92045-24-4," No repeat-dose toxicity studies were located for oral toxicity of VGOs/HGOs/Distillate fuels. However, supporting information is available, with two studies conducted on petroleum substances in other categories; a sub-chronic study on a Kerosine (CAS 8008-20-6) and a chronic study on a Highly Refined Base Oil (CAS 8042-47-5). These do not contain significant amounts of the PAH constituents considered to be the drivers of toxicological hazard for VHGO, but have other constituents in common. They help to demonstrate that no significant toxicological hazard is expected from other aliphatic (paraffinic and naphthenic) and aromatic (mono- and di- aromatic) constituents.   In addition, one oral sub-chronic study is proposed on a VHGO substance containing high levels of PAH constituents.   For sub-chronic inhalation toxicity of VGOs/HGOs/Distillate fuels, a conservative sub-chronic NOAEC of 750 mg/m3 was determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of >1710 mg/m3 was established for systemic effects, based on no significant findings at this level (OECD 413).   In a subacute dermal repeated-dose toxicity test, the NOEL level based on dermal irritation was 0.0001 mL/kg and a NOEL of 0.5 mL/kg was calculated for systemic toxicity (OECD 410). For subchronic dermal toxicity, a NOAEL of 30 mg/kg body weight/day appears appropriate for VGOs/HGOs/Distillate fuels based on changes in haematological parameters (decreased RBC, haemoglobin, HCT), clinical chemistry values (increased urea nitrogen and cholesterol) parameters and organ weight effects (increased liver weight, decreased thymus weight). The NOAEL for local effects is 125 mg/kg body weight/d, based on histopathological changes present at the application site (OECD 411). In addition, a recent study to OECD 411 and GLP was conducted on a member of the VHGO category. This showed low systemic toxicity (NOAEL 600 mg/kg/day), with higher doses not possible due to excessive local irritation. This study was conducted on a substance in the category low in PAH content (the constituent expected to drive toxicological hazard). ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/138ca04b-28a0-4607-9410-2d67ab4f7307/documents/6eb3217d-cfcb-4c55-a348-ca82d2c18ff0_af86d14c-ee27-4da2-b17c-300fc45d2de9.html,,,,,, "Gas oils (petroleum), hydrotreated light vacuum",92045-24-4,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/138ca04b-28a0-4607-9410-2d67ab4f7307/documents/6eb3217d-cfcb-4c55-a348-ca82d2c18ff0_af86d14c-ee27-4da2-b17c-300fc45d2de9.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,30 mg/kg bw/day,,rat "Gas oils (petroleum), hydrotreated light vacuum",92045-24-4,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/138ca04b-28a0-4607-9410-2d67ab4f7307/documents/6eb3217d-cfcb-4c55-a348-ca82d2c18ff0_af86d14c-ee27-4da2-b17c-300fc45d2de9.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Gas oils (petroleum), hydrotreated light vacuum",92045-24-4,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/138ca04b-28a0-4607-9410-2d67ab4f7307/documents/6eb3217d-cfcb-4c55-a348-ca82d2c18ff0_af86d14c-ee27-4da2-b17c-300fc45d2de9.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Gas oils (petroleum), hydrotreated light vacuum",92045-24-4," Acute Oral Toxicity: Acute oral toxicity of #2 home heating oil, was evaluated in male and female rats following a single oral gavage administration of the test material at different concentrations (similar to OECD 401).  The  LD50 for #2 home heating oil is 21.1 mL/kg body weight (approx 17,900 mg/kg). Based on all acute oral toxicity studies, the LD50 for VGOs/HGOs/Distillate fuels is > 5000 mg/kg bw. Acute Inhalation Toxicity: Acute inhalation toxicity of naval distillate in male and female rats was evaluated in a study involving whole-body exposure  for 4 hours (similar to OECD 403).  The acute inhalation LC50 was 4.1 mg/L . Acute Dermal Toxicity: In an acute dermal toxicity study, male and female New Zealand White rabbits were exposed to #2 home heating oil for 24 hours at a dose level of 5 mL/kg (approx 4300 mg/kg). The animals were then observed for 14 days (similar to OECD 402).  Based on this study, the acute dermal LD50 is > 4300 mg/kg.   ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/138ca04b-28a0-4607-9410-2d67ab4f7307/documents/50ca8717-e805-460b-bb99-b647882e2c88_af86d14c-ee27-4da2-b17c-300fc45d2de9.html,,,,,, "Gas oils (petroleum), hydrotreated light vacuum",92045-24-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/138ca04b-28a0-4607-9410-2d67ab4f7307/documents/50ca8717-e805-460b-bb99-b647882e2c88_af86d14c-ee27-4da2-b17c-300fc45d2de9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), hydrotreated light vacuum",92045-24-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/138ca04b-28a0-4607-9410-2d67ab4f7307/documents/50ca8717-e805-460b-bb99-b647882e2c88_af86d14c-ee27-4da2-b17c-300fc45d2de9.html,,dermal,LD50,"4,300 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), hydrotreated light vacuum",92045-24-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/138ca04b-28a0-4607-9410-2d67ab4f7307/documents/50ca8717-e805-460b-bb99-b647882e2c88_af86d14c-ee27-4da2-b17c-300fc45d2de9.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "Gas oils (petroleum), light vacuum",64741-58-8," There are seven oral sub-acute repeated dose oral studies conducted according to OECD TG 422. In sub-acute oral studies on CAS Numbers 64741-77-1, 68476-34-6, 68476-30-2 and 68334 -30 -5, there were no treatment-related adverse effects on systemic toxicity parameters up to and including the highest doses tested (1000 mg/kg/day for 68334 -30 -5 and 750 mg/kg/day for the remaining CAS numbers) and accordingly the NOAELs were set at these levels. In a sub-acute oral study on CAS 68476 -31 -3 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 750 mg/kg/day for males and 100 mg/kg/day for females.   In a sub-acute oral study on CAS 64741 -49 -7 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 750 mg/kg/day for males and 300 mg/kg/day for females. In a sub-acute oral study on CAS 68476 -31 -3 (conducted according to OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 300 mg/kg/day for males and females. Supporting information is available, with two studies conducted on petroleum substances in other categories; a sub-chronic study on a Kerosine (CAS 8008-20-6) and a chronic study on a Highly Refined Base Oil (CAS 8042-47-5). These do not contain significant amounts of the PAH constituents considered to be the drivers of toxicological hazard for VHGO, but have other constituents in common. They help to demonstrate that no significant toxicological hazard is expected from other aliphatic (paraffinic and naphthenic) and aromatic (mono- and di- aromatic) constituents.   In addition, one oral sub-chronic study is proposed on a VHGO substance containing high levels of PAH constituents.   For sub-chronic inhalation toxicity of VGOs/HGOs/Distillate fuels, a conservative sub-chronic NOAEC of 750 mg/m3 was determined for local effects on the lung (increased relative wet weight in the absence of histopathological change). A NOAEC of >1710 mg/m3 was established for systemic effects, based on no significant findings at this level (OECD 413).   In a subacute dermal repeated-dose toxicity test, the NOEL level based on dermal irritation was 0.0001 mL/kg and a NOEL of 0.5 mL/kg was calculated for systemic toxicity (OECD 410). For subchronic dermal toxicity, a NOAEL of 30 mg/kg body weight/day appears appropriate for VGOs/HGOs/Distillate fuels based on changes in haematological parameters (decreased RBC, haemoglobin, HCT), clinical chemistry values (increased urea nitrogen and cholesterol) parameters and organ weight effects (increased liver weight, decreased thymus weight). The NOAEL for local effects is 125 mg/kg body weight/d, based on histopathological changes present at the application site (OECD 411). In addition, a recent study to OECD 411 and GLP was conducted on a member of the VHGO category. This showed low systemic toxicity (NOAEL 600 mg/kg/day), with higher doses not possible due to excessive local irritation. This study was conducted on a substance in the category low in PAH content (the constituent expected to drive toxicological hazard). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e86d6a4f-e136-45f8-b1f6-193f4afa41cc/documents/246ae508-16eb-446c-afd1-ad680080afdb_bf62dd82-68a4-472f-b41d-fb4400f45ee9.html,,,,,, "Gas oils (petroleum), light vacuum",64741-58-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e86d6a4f-e136-45f8-b1f6-193f4afa41cc/documents/246ae508-16eb-446c-afd1-ad680080afdb_bf62dd82-68a4-472f-b41d-fb4400f45ee9.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,30 mg/kg bw/day,,rat "Gas oils (petroleum), light vacuum",64741-58-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e86d6a4f-e136-45f8-b1f6-193f4afa41cc/documents/246ae508-16eb-446c-afd1-ad680080afdb_bf62dd82-68a4-472f-b41d-fb4400f45ee9.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Gas oils (petroleum), light vacuum",64741-58-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e86d6a4f-e136-45f8-b1f6-193f4afa41cc/documents/246ae508-16eb-446c-afd1-ad680080afdb_bf62dd82-68a4-472f-b41d-fb4400f45ee9.html,Repeated dose toxicity – local effects,inhalation,NOAEC,880 mg/m3,adverse effect observed,rat "Gas oils (petroleum), light vacuum",64741-58-8," Acute Oral Toxicity: Acute oral toxicity of #2 home heating oil, was evaluated in male and female rats following a single oral gavage administration of the test material at different concentrations (similar to OECD 401).  The  LD50 for #2 home heating oil is 21.1 mL/kg body weight (approx 17,900 mg/kg). Based on all acute oral toxicity studies, the LD50 for VGOs/HGOs/Distillate fuels is > 5000 mg/kg bw. Acute Inhalation Toxicity: Acute inhalation toxicity of naval distillate in male and female rats was evaluated in a study involving whole-body exposure  for 4 hours (similar to OECD 403).  The acute inhalation LC50 was 4.1 mg/L . Acute Dermal Toxicity: In an acute dermal toxicity study, male and female New Zealand White rabbits were exposed to #2 home heating oil for 24 hours at a dose level of 5 mL/kg (approx 4300 mg/kg). The animals were then observed for 14 days (similar to OECD 402).  Based on this study, the acute dermal LD50 is > 4300 mg/kg.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e86d6a4f-e136-45f8-b1f6-193f4afa41cc/documents/50ca8717-e805-460b-bb99-b647882e2c88_bf62dd82-68a4-472f-b41d-fb4400f45ee9.html,,,,,, "Gas oils (petroleum), light vacuum",64741-58-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e86d6a4f-e136-45f8-b1f6-193f4afa41cc/documents/50ca8717-e805-460b-bb99-b647882e2c88_bf62dd82-68a4-472f-b41d-fb4400f45ee9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), light vacuum",64741-58-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e86d6a4f-e136-45f8-b1f6-193f4afa41cc/documents/50ca8717-e805-460b-bb99-b647882e2c88_bf62dd82-68a4-472f-b41d-fb4400f45ee9.html,,dermal,LD50,"4,300 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), light vacuum",64741-58-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e86d6a4f-e136-45f8-b1f6-193f4afa41cc/documents/50ca8717-e805-460b-bb99-b647882e2c88_bf62dd82-68a4-472f-b41d-fb4400f45ee9.html,,inhalation,LC50,"4,100 mg/m3",adverse effect observed, "Gas oils (petroleum), straight-run",64741-43-1," In sub-acute oral studies on CAS 68814-87-9, 64741-43-1 and CAS 64741-44-2 (conducted according to OECD TG 422), there were no treatment-related adverse effects on systemic toxicity parameters up to and including the highest dose tested (750 mg/kg/day) and accordingly the NOAELs were set at this level. In a sub-acute oral study on CAS 68915-96-8 (conducted according to OECD TG 422) at doses of 100, 300, 750 and 1000 mg/kg/day. The No Observed Adverse Effect Level (NOAEL) for systemic toxicity in Wistar Rats was determined to be 100 mg/kg/day for males and 300 mg/kg/day for females.  This is the substance in the category provisionally selected for higher tier testing in the test proposals already submitted. A key 'read across' 90-day dermal study in rats was identified in which vacuum tower overheads was applied to the shaved skin of rats, 5 days a weeks for 90-days. The NOAEL was 30 mg/kg/day, based on findings in liver, thymus and blood. A 28 day repeated dose toxicity studies in rabbits was identified for dermal exposure, plus a supporting 28 day dermal study in rats.  There was one key read-across 90-day repeated dose toxicity study (OECD 413) for inhalation. For the read-across 90-day inhalation study, a NOAEC of 0.88 mg/L for local effects on the lung (increased relative wet weight in the absence of histopathological change) was established in rats expose to aerosol.  A NOAEC of greater than or equal to 1.71 mg/L is established for systemic effects, based on no significant findings at this level. For the 28-day dermal study, a LOAEL of 200 mg/kg/day was established based on local irritation. No NOEL was determined for local irritation.  The NOAEL for systemic effects in rabbits following repeated dermal exposure was greater than or equal to 2000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/773bef1f-7604-4092-8b5d-e2748a5fec22/documents/c244fb29-9c5d-4dcc-9137-c575a1def977_1f0b993e-427a-4d45-9f9a-45d700a60915.html,,,,,, "Gas oils (petroleum), straight-run",64741-43-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/773bef1f-7604-4092-8b5d-e2748a5fec22/documents/c244fb29-9c5d-4dcc-9137-c575a1def977_1f0b993e-427a-4d45-9f9a-45d700a60915.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,30 mg/kg bw/day,,rat "Gas oils (petroleum), straight-run",64741-43-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/773bef1f-7604-4092-8b5d-e2748a5fec22/documents/c244fb29-9c5d-4dcc-9137-c575a1def977_1f0b993e-427a-4d45-9f9a-45d700a60915.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,710 mg/m3",,rat "Gas oils (petroleum), straight-run",64741-43-1,"Key acute oral (OECD 401), dermal (OECD 402), and inhalation (OECD 403) studies were identified for straight run gas oils.  LD50 and LC50 values were as follows:• The oral LD50 was > 5000 mg/kg bw in male and female rats.• The dermal LD50 was > 2000 mg/kg bw in male and female rabbits.• The LC50 was > 2.53 mg/L in male and female rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/773bef1f-7604-4092-8b5d-e2748a5fec22/documents/09fd26d0-b3c1-4ae3-8630-9fa8f878316a_1f0b993e-427a-4d45-9f9a-45d700a60915.html,,,,,, "Gas oils (petroleum), straight-run",64741-43-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/773bef1f-7604-4092-8b5d-e2748a5fec22/documents/09fd26d0-b3c1-4ae3-8630-9fa8f878316a_1f0b993e-427a-4d45-9f9a-45d700a60915.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), straight-run",64741-43-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/773bef1f-7604-4092-8b5d-e2748a5fec22/documents/09fd26d0-b3c1-4ae3-8630-9fa8f878316a_1f0b993e-427a-4d45-9f9a-45d700a60915.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Gas oils (petroleum), straight-run",64741-43-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/773bef1f-7604-4092-8b5d-e2748a5fec22/documents/09fd26d0-b3c1-4ae3-8630-9fa8f878316a_1f0b993e-427a-4d45-9f9a-45d700a60915.html,,inhalation,LC50,"2,530 mg/m3",adverse effect observed, "Gases (petroleum), extractive, C3-5, butene-isobutylene-rich",68477-42-9,"Members of the C4 high 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. Data after inhalational exposure are available on one of the streams in this category (All CAS numbers are; 68476-52-8, 68477-42-9, 68955-28-2, 87741-01-3, 92045-23-3) and on the component substances (1,3-butadiene, butane, isobutane and butene isomers) and indicate that the sub-chronic toxicity of this category is low. Inhalation exposure is the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in rats or mice in inhalation studies ranging from 7 weeks to 2 years on CAS no. 68476-52-82, butane, isobutane and 2-methylpropene. Nasal lesions were observed in 2 year studies on 2-methylpropene at the highest concentration in male rats. 1,3-Butadiene had low repeat dose toxicity in humans and rats (the most appropriate test species). The mouse was the most sensitive species where the target organs are bone marrow, ovary and testis. Species differences in metabolism are believed to be responsible for the species specific toxicity with humans being more similar to rats The NOAEL of 1000 ppm (2212 mg/m3) was identified from the key study on 1,3-butadiene in rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05158ee3-c8c7-4233-aeb1-86c1e215aa39/documents/IUC5-bd89e6c4-93bf-42b1-8fa1-6e5b10ffc977_e4ec7f9b-bfd9-4c2d-ac65-db60f5b2fab9.html,,,,,, "Gases (petroleum), extractive, C3-5, butene-isobutylene-rich",68477-42-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05158ee3-c8c7-4233-aeb1-86c1e215aa39/documents/IUC5-bd89e6c4-93bf-42b1-8fa1-6e5b10ffc977_e4ec7f9b-bfd9-4c2d-ac65-db60f5b2fab9.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"2,212 mg/m3",, "Gases (petroleum), extractive, C3-5, butene-isobutylene-rich",68477-42-9,"Members of the C4 high 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. Data are available on some members of the streams in this category (All CAS numbers are; 68476-52-8, 68477-42-9, 68955-28-2, 87741-01-3, 92045-23-3) and on the component substances (1,3-butadiene, butane, isobutane and butene isomers) and indicate that the acute inhalational toxicity of this category is low. The LC50 values are in excess of 10,000 ppm (22,948 mg/m3), limited data suggests that 1,3-butadiene is not acutely toxic in humans and butane and isobutane are considered to be Generally Recognised as Safe and may be used in food products. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05158ee3-c8c7-4233-aeb1-86c1e215aa39/documents/IUC5-5e90e6d4-4caa-4f19-8802-7619853e36ca_e4ec7f9b-bfd9-4c2d-ac65-db60f5b2fab9.html,,,,,, Genipin,6902-77-8,"A precise discriminating dose or precise LD50 was not possible to determine based on these results. However, based on the absence of mortality at 100 mg/kg and mortality of > 70% at 200 mg/kg, an LD can be assumed to be in the range leading to Acute Tox 3 for classification purposes. A supporting study noted mortality of approximately 50% at approximately 840 mg/kg when dosed in the form of the plant extract.  This study showed that liver is a possible target organ.  Although these research tests do not meet the criteria for modern regulatory testing and were apparently not performed to GLP, it is possible to conclude classification as Acute Tox 3.  No further acute oral toxicity testing can be justified.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed483b61-b452-4eff-b15b-2fa60ebeda66/documents/b0087eee-1f65-4a3c-9f2d-1853a9265bdc_d8604c21-160a-4aca-80bf-500af9100ea4.html,,,,,, Genipin,6902-77-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed483b61-b452-4eff-b15b-2fa60ebeda66/documents/b0087eee-1f65-4a3c-9f2d-1853a9265bdc_d8604c21-160a-4aca-80bf-500af9100ea4.html,,oral,LD50,ca.200 mg/kg bw,adverse effect observed, Germanium,7440-56-4," Repeated dose oral toxicity: Animal repeated dose oral toxicity studies after exposure to GeO2 are demonstrating nephrotoxicity and myopathy. The study reporting the most sensitive (most relevant) data point (Sanai et al., 1991) was used: LOAEL= 0.0375g/kg BW/d inducing systemic toxicity by weight loss, anemia, and hypo-proteinemia and renal dysfunction (indicated by the increase of blood urea nitrogen and the decrease of creatinine clearance). In this 24-week feeding study, a dose-dependent effect of GeO2 is demonstrated in rats. The lowest LOAEL, which was reported by Yim et al., 1999 (0.01g/kg BW/d), was not retained for further assessment since this effect concentration was solely based on the subcellular effects mitochondrial myopathia. Repeated dose inhalation toxicity: 28d repeated dose inhalation (Arts et al., 1990): In a guideline study, conducted to GLP, administration of rats to Germanium metal powder by inhalation 6h/d and 5d/wk for 4wk at doses of 0, 9.9, 65.1, or 251.4 mg/m3. From this study local effects in the lungs resulted in a NOAEC of 9.9 mg Ge/m3 and a LOAEC of 65.1 mg Ge/m3. For systemic effects, the concentration of 251.4 represents a NOAEC because the slight changes in creatinin levels (sensitive indicator of renal function) found at this concentration occurred only in one sex and was not dose-dependent. Histopathological changes in the kidney did not occur in this study even at higher concentrations. Repeated dose dermal toxicity: No repeated dose toxicity study by the dermal route were identified. Testing by the dermal route has been waived. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/400c57a1-a6c3-4a4a-94a2-eb6f61de3f27/documents/380cafb8-3f2d-4fd9-87e2-7e48cb165102_1d20ecbd-ab15-4810-b7ef-31e8139f98d7.html,,,,,, Germanium,7440-56-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/400c57a1-a6c3-4a4a-94a2-eb6f61de3f27/documents/380cafb8-3f2d-4fd9-87e2-7e48cb165102_1d20ecbd-ab15-4810-b7ef-31e8139f98d7.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,251.4 mg/m3,,rat Germanium,7440-56-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/400c57a1-a6c3-4a4a-94a2-eb6f61de3f27/documents/380cafb8-3f2d-4fd9-87e2-7e48cb165102_1d20ecbd-ab15-4810-b7ef-31e8139f98d7.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,37.5 mg/kg bw/day,,rat Germanium,7440-56-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/400c57a1-a6c3-4a4a-94a2-eb6f61de3f27/documents/380cafb8-3f2d-4fd9-87e2-7e48cb165102_1d20ecbd-ab15-4810-b7ef-31e8139f98d7.html,Repeated dose toxicity – local effects,inhalation,LOAEC,65.1 mg/m3,adverse effect observed,rat Germanium,7440-56-4," For assessing the acute oral toxicity of Ge, reference has been made to toxicity data obtained by standard acute oral toxicity testing on GeO2. Bio-elution data in artificial gastric body fluids demonstrate that the solubility of Ge in Ge metal powder is lower than the solubility of Ge from GeO2. Assessment of the acute oral toxicity of germanium dioxide in Arulnesan et al 2012: An Acute Oral Toxicity Study of Germanium Dioxide, was carried out according to OECD 425. The test item was suspended in 1% methyl cellulose at a concentration of 200 mg/mL. The first animal was dosed at 2000 mg/kg at a dose volume of 10.0 mL/kg. Since this first animal survived, four additional animals were dosed at 2-day intervals. A total of 5 female CD (Sprague-Dawley) rats were dosed. All animals received the test item by oral gavage using a feeding cannula inserted into the stomach of the animals. The animals were observed for a 14-day period after dosing. Body weights were recorded prior to test item administration (i.e., Day 0), on Day 7 and prior to necropsy on Day 14. No mortalities were observed post dosing and during the 14-day observation period in any of the animals. All rats gained body weight by Day 7 and at the end of the study. At the end of the 14-day observation period, each animal was sacrificed and submitted for gross necropsy. No gross pathological findings were observed in any of the rats at necropsy. Based on the foregoing results, the acute oral LD50 in rats of the test item, Germanium Dioxide, was found to be in excess of 2000 mg/kg. Therefore, the test item is considered not to present a significant acute toxic risk if swallowed. Assessment of the acute inhalation toxicity of germanium in Arts et al 1990: The acute (4 -hour) inhalation toxicity of germanium powder was studied by exposing total-body group of rats, consisting of five male and five female rats, to a test atmosphere containing germanium powder at a concentration of 3.86 or 5.34 g/m3 in air respectively for one single time for a period of 4 hours. It was concluded that the 4 hours LC50 value of germanium powder was higher than 5.34 g/m3 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/400c57a1-a6c3-4a4a-94a2-eb6f61de3f27/documents/5e7aa77a-d1cf-44cd-acdb-db2712bef4fe_1d20ecbd-ab15-4810-b7ef-31e8139f98d7.html,,,,,, Germanium,7440-56-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/400c57a1-a6c3-4a4a-94a2-eb6f61de3f27/documents/5e7aa77a-d1cf-44cd-acdb-db2712bef4fe_1d20ecbd-ab15-4810-b7ef-31e8139f98d7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Germanium,7440-56-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/400c57a1-a6c3-4a4a-94a2-eb6f61de3f27/documents/5e7aa77a-d1cf-44cd-acdb-db2712bef4fe_1d20ecbd-ab15-4810-b7ef-31e8139f98d7.html,,inhalation,LC50,"5,340 mg/m3",no adverse effect observed, Germanium tetrachloride,10038-98-9,"-28d repeated dose inhalation publication (Arts et al., 1994) (KL=1): In a guideline study, conducted to GLP, administration of rats to Germanium dioxide by inhalation 6h/d and 5d/wk for 4wk at doses of 0,16, 72, or 309 mg/m3, had adverse effects at the highest dose especially on growth, kidneys and liver. A NOAEL of 72mg/m3 was established.- Six repeated dose oral toxicity studies were retained for a potential read across approach. The study reporting the most sensitive (most relevant) data point (Sanai et al., 1991) was used: LOAEL (40w) = 0.0375g/kg BW/d inducing systemic toxicity by weight loss, anemia, and hypo-proteinemia and renal dysfunction (indicated by the increase of blood urea nitrogen and the decrease of creatinine clearance). This effect concentration was converted to a LOAEL for the standard exposure period of 13weeks (0.115g/kg BW/d). Remark: the lowest LOAEL, which was reported by Yim et al., 1999 (0.01g/kg BW/d), was not retained for further assessment since this effect concentration was solely based on the subcellular effects mitochondrial myopathia. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The study is GLP compliant and of high quality (klimisch score=1). The other available studies are Klimisch score=4 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 6 repeated dose oral toxicity studies on GeO2 are available and retained for potential read across approach but the study of Sanai et al (1991) was used since reporting the most sensitive and most relevant data point. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc2115e2-406d-4b04-b6e0-5a0b83550407/documents/IUC5-e9854350-9a67-4d34-ad02-77f70d4ceee7_efb3a9e2-deb0-444e-abcc-181783272a20.html,,,,,, Germanium tetrachloride,10038-98-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc2115e2-406d-4b04-b6e0-5a0b83550407/documents/IUC5-e9854350-9a67-4d34-ad02-77f70d4ceee7_efb3a9e2-deb0-444e-abcc-181783272a20.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,72 mg/m3,,rat Germanium tetrachloride,10038-98-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc2115e2-406d-4b04-b6e0-5a0b83550407/documents/IUC5-e9854350-9a67-4d34-ad02-77f70d4ceee7_efb3a9e2-deb0-444e-abcc-181783272a20.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,37.5 mg/kg bw/day,,rat Germanium tetrachloride,10038-98-9,"Acute rat inhalation test (Terrill et al., 1990, Hazleton laboratories) (KL=2):A single one-hour (3.3g/m³) whole body exposure resulted in severe toxic effects. By vapour exposure, GeCl4 was unique in that the injury of tissue (necrosis) was markedly greater for the skin than for the respiratory tract. Due to the corrosive nature of the test material and the clinical signs displayed by the animals, all animals were sacrificed for humane reasons on test day 4. The exposure concentration 3.3g/m³needs to be considered as an LC100 (1h) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc2115e2-406d-4b04-b6e0-5a0b83550407/documents/IUC5-1f76ba12-3fe7-4c18-9c41-fd67589c1a8d_efb3a9e2-deb0-444e-abcc-181783272a20.html,,,,,, Gestonorone,2137-18-0,"There are no repeat-dose studies conducted with ZK 5686; read across with results of studies with gestonorone caproate (ZK 5623):Subcutaneous, 4 weeks (Rat-Spraque-Dawley, non-GLP, doses: 0/ 125 / 500 mg/kg, 6 times/week): NOEL < 125 mg/kg[Schering AG, 1967-09-01]Subcutaneous, 26 weeks, (Rat-Spraque-Dawley, non-GLP, doses: 0/ 5/ 25/ 125 mg/kg, once weekly): NOEL< 5 mg/kg[Schering AG, 1967-09-01]Intramuscular, up to 78 weeks (rat-CD, non-GLP, doses: 0/ 1.25/ 8.75/ 17.5, up to 5 injections/week): NOEL < 1.25 mg/kg[Schering AG, 1966-11-11]Intramuscular, up to 52 weeks (dog-Beagle, non-GLP, doses: 0/ 1.25/ 8.75/ 17.5 mg/kg, up to 5 injections/week): NOEL < 1.25 mg/kg[Schering AG, 1966-11-07] ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/54548d1c-863d-4cad-ab4c-bcbb0c6afe6c/documents/IUC5-5a857459-ea04-4765-aea1-d88486d58600_f47ed2c7-f378-48e0-aa43-de10b3c95ab4.html,,,,,, Gestonorone,2137-18-0,"There is no acute toxicity study conducted with ZK 5686; read across approach with results of studies with gestonorone coproate (ZK 5623):Oral (Mouse, non-GLP): LD50 > 4000 mg/kg[Schering AG, 1968-07-31]Oral (Rat, non-GLP): LD50 > 4000 mg/kg[Schering AG, 1971-07-08]Subcutaneous (Mouse, non-GLP): LD50 > 4000 mg/kg[Schering AG, 1968-07-31]Subcutaneous (Guinea pig-White Pirbright, non-GLP): LD50 > 8000 mg/kg[Schering AG, 1965-04-13]Intraperitoneal (Mouse, non-GLP): LD50 > 4000 mg/kg[Schering AG, 1968-07-31]Intraperitoneal (Mouse-NMRI, non-GLP): LD50 = 6000 mg/kg[Schering AG, 1965-04-13]Intraperitoneal (Rat-Wistar, non-GLP): LD 50 = 7000 mg/kg[Schering AG, 1965-04-13]Intramuscular (Dog-Beagle, female, non-GLP): LD50 > 150 mg/kg (2000 g/dog)[Schering AG, 1966-11-29] ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54548d1c-863d-4cad-ab4c-bcbb0c6afe6c/documents/IUC5-dda1b750-1c08-47a5-820e-d33b7949f51d_f47ed2c7-f378-48e0-aa43-de10b3c95ab4.html,,,,,, "glucan 1,4-alpha-maltohydrolaseIUBMB 3.2.1.133",160611-47-2," No signs of toxicity were observed among the rats dosed with a single oral dose of up to 3000 mg/kg bw. Therefore, a LD50 could not be estimated. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bd8b962-ac4b-4ee5-8e1d-5326a9e9ab10/documents/3f9a7232-8ba6-4eba-876e-ae97a7638a2a_cb873cb8-c7d7-4c12-9432-4bf601c791fe.html,,,,,, "Glucanase, endo-1,3(4)-β-",62213-14-3," It was concluded that oral administration of beta-glucanase batch PPB24534, to Sprague Dawley rats at dosages up to 10.0 mL/kg/day for 13 weeks was well-tolerated and did not produce any toxicologically significant changes. Consequently, the no-observed-adverse-effect level (NOAEL) in this study was considered to be 10.0 mL/kg/day, equivalent to 1266 mg TOS/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0503a2d3-4561-4463-9ace-faa724f88b30/documents/6a884205-1bd1-4013-a8f1-50cd31417e68_62893e59-d6ad-453f-ae51-afa142fab0ca.html,,,,,, "Glucanase, endo-1,3(4)-β-",62213-14-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0503a2d3-4561-4463-9ace-faa724f88b30/documents/6a884205-1bd1-4013-a8f1-50cd31417e68_62893e59-d6ad-453f-ae51-afa142fab0ca.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,266 mg/kg bw/day",,rat "Glucanase, endo-1,3(4)-β-",62213-14-3," The acute toxicity of beta-glucanase was not tested, however, a 13-week repeated dose toxicity was conducted. It was concluded that oral administration of beta-glucanase batch PPB24534, to Sprague Dawley rats at dosages up to 10.0 mL/kg/day for 13 weeks was well-tolerated and did not produce any toxicologically significant changes. Consequently, the no-observed-adverse-effect level (NOAEL) in this study was considered to be 10.0 mL/kg/day, equivalent to 1266 mg TOS/kg/day. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0503a2d3-4561-4463-9ace-faa724f88b30/documents/2db3e42c-e4c9-4a5e-b698-d9339698adcf_62893e59-d6ad-453f-ae51-afa142fab0ca.html,,,,,, "Glucanase, β-",9074-98-0," NOAELs for the test item, very similar analoguous enzymes and the test item in mixture with another enzyme are ≥ 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0271d8f6-48eb-49f2-8276-be417c25e20a/documents/6af6c7cd-e672-4aeb-8903-a0376e41f837_aae6fb83-8aef-4f08-aa90-6d6b1d38ebf6.html,,,,,, "Glucanase, β-",9074-98-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0271d8f6-48eb-49f2-8276-be417c25e20a/documents/6af6c7cd-e672-4aeb-8903-a0376e41f837_aae6fb83-8aef-4f08-aa90-6d6b1d38ebf6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Glucanase, β-",9074-98-0," The acute oral LD50 of four close analogues of the test substance was determined to be ≥ 2000 mg/kg bw. The acute inhalation LC50 (4h) of a close analogue of the test substance was determined to be ≥ 2.25 mg/L air, which was the highest attainable concentration. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0271d8f6-48eb-49f2-8276-be417c25e20a/documents/99a66b7d-48d4-40ca-827d-efdbde29523f_aae6fb83-8aef-4f08-aa90-6d6b1d38ebf6.html,,,,,, "Glucanase, β-",9074-98-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0271d8f6-48eb-49f2-8276-be417c25e20a/documents/99a66b7d-48d4-40ca-827d-efdbde29523f_aae6fb83-8aef-4f08-aa90-6d6b1d38ebf6.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Glucanase, β-",9074-98-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0271d8f6-48eb-49f2-8276-be417c25e20a/documents/99a66b7d-48d4-40ca-827d-efdbde29523f_aae6fb83-8aef-4f08-aa90-6d6b1d38ebf6.html,,inhalation,discriminating conc.,"2,250 mg/m3",no adverse effect observed, glutamyl endopeptidase,137010-42-5," Glutamyl endopeptidase was not tested, but a similar enzyme, trypsin, was tested orally in rats for up to 4 weeks. It was concluded that the twice-daily oral administration of SP387/TL-1 to Sprague-Dawley rats for 4 weeks at a range of enzyme activities up to a total daily dose of 3.93 g TOS/kg bwt/day was generally well-tolerated, though at the highest dose level there were stomach erosions that were considered responses to an irritant test material and these findings were considered adverse. All other findings in this study were considered non-adverse. In view of the presence of erosions in the high dose animals the no-observed-adverse-effect level (NOAEL) was considered to be 1.96 g TOS/kg bwt/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a1d0bd4-f4e5-4435-8790-15605aa10bc8/documents/de55cc5a-8d0b-4c23-bfdf-f1dc9e74b5b1_ccb0b636-087b-473f-a246-733294751471.html,,,,,, glutamyl endopeptidase,137010-42-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a1d0bd4-f4e5-4435-8790-15605aa10bc8/documents/de55cc5a-8d0b-4c23-bfdf-f1dc9e74b5b1_ccb0b636-087b-473f-a246-733294751471.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,960 mg/kg bw/day",,rat glutamyl endopeptidase,137010-42-5," Glutamyl endopeptidase was not tested, but a similar enzyme, subtilisin, was tested in rats. The LD50 value was 1.8 g/kg. The main clinical symptoms and the causes of death were ascribed to gastrointestinal disturbances. From other studies, it is known that when the proteolytic activity of subtilisin is inactivated by treatment with hydrochloric acid, the toxicological potential is decreased significantly. Thus, the proteolytic activity contributes essentially to the toxic effect. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a1d0bd4-f4e5-4435-8790-15605aa10bc8/documents/9788fb11-eecf-48e5-8140-964702b19cdf_ccb0b636-087b-473f-a246-733294751471.html,,,,,, glutamyl endopeptidase,137010-42-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a1d0bd4-f4e5-4435-8790-15605aa10bc8/documents/9788fb11-eecf-48e5-8140-964702b19cdf_ccb0b636-087b-473f-a246-733294751471.html,,oral,LD50,"1,800 mg/kg bw",adverse effect observed, "Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts",161074-67-5,"Test material: the liquid marketed product batch LCE08082 which contains ca.27.5% of the solid substance ""Glutens, hydrozylates, reaction products with lauroyl chloride, sodium salts"".   The oral administration of LCE08082 to rats for a period of up to fifty five days at dose levels of up to 1000 mg/kg/day resulted in treatment related changes in males treated with 1000 and 300 mg/kg/day. The 'No Observed Effect Level' (NOEL) for males was therefore, considered to be 100 mg/kg/day. No such effects were detected in females treated with 1000 or 300 mg/kg/day and the 'No Observed Effect Level' (NOEL) for females was therefore, considered to be 1000 mg/kg/day. The gastric changes detected in 1000 and 300 mg/kg/day males may be considered to be adverse, however because a squamous-lined counterpart to the rodent forestomach is not present in human stomachs, these effects in this study, are not considered to be indicative of a hazard to human health and, for the purposes of hazard evaluation, the “No Observed Adverse Effect Level” (NOAEL) for males, should be regarded as 1000 mg/kg/day. No treatment-related effects were detected in the reproductive parameters measured, therefore the ‘No Observed Effect Level’ (NOEL) for reproductive toxicity including fertility and mating in adults and for developmental toxicity in their subsequent progeny was considered to be 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b013195-678b-4cba-8e14-4e86b33cf3a1/documents/12f5fa91-8307-43d3-a853-24aad11a779f_30e776d1-d571-4738-9be8-d842496da6f4.html,,,,,, "Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts",161074-67-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b013195-678b-4cba-8e14-4e86b33cf3a1/documents/12f5fa91-8307-43d3-a853-24aad11a779f_30e776d1-d571-4738-9be8-d842496da6f4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts",161074-67-5,"Test material: the liquid marketed product which contains ca.27.5% of the solid substance ""Glutens, hydrozylates, reaction products with lauroyl chloride, sodium salts"". No hazard was identified after one administration by oral or dermal route in rodents according to OECD n° 401 and 402. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b013195-678b-4cba-8e14-4e86b33cf3a1/documents/2f1a8ec5-9d13-4812-9808-85693f6973ef_30e776d1-d571-4738-9be8-d842496da6f4.html,,,,,, "Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts",161074-67-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b013195-678b-4cba-8e14-4e86b33cf3a1/documents/2f1a8ec5-9d13-4812-9808-85693f6973ef_30e776d1-d571-4738-9be8-d842496da6f4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Glutens, hydrolyzates, reaction products with lauroyl chloride, sodium salts",161074-67-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b013195-678b-4cba-8e14-4e86b33cf3a1/documents/2f1a8ec5-9d13-4812-9808-85693f6973ef_30e776d1-d571-4738-9be8-d842496da6f4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Glycerides, C12-18 mono- and di-",91052-49-2,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f1fa2d3-6efc-41df-a4bf-b2572a802810/documents/IUC5-100d09c9-bec5-46ea-87dd-82f55c82d3ca_aedfd500-e0d3-4fca-a664-387472a68191.html,,,,,, "Glycerides, C12-18 mono- and di-",91052-49-2,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f1fa2d3-6efc-41df-a4bf-b2572a802810/documents/IUC5-694f4908-af3e-4729-afa2-3635b21d3d49_aedfd500-e0d3-4fca-a664-387472a68191.html,,,,,, "Glycerides, C12-18 mono-, di- and tri-",91052-53-8," A 28 days study on rats (similar to OECD 422) is available on a read-across substance (CAS 91052-13-0). Based on the results, a parental, reproduction and developmental No Observed Adverse Effect Level (NOAEL) of at least 1000 mg/kg/day was derived. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9342de0e-09f3-44a9-bde7-7028ebcccf04/documents/4e5e2db3-596d-4e4a-9237-bf1c4266a7ed_68450793-7f6a-49fa-bcc1-25328117f96d.html,,,,,, "Glycerides, C12-18 mono-, di- and tri-",91052-53-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9342de0e-09f3-44a9-bde7-7028ebcccf04/documents/4e5e2db3-596d-4e4a-9237-bf1c4266a7ed_68450793-7f6a-49fa-bcc1-25328117f96d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Glycerides, C12-18 mono-, di- and tri-",91052-53-8," An acute oral toxicity study (OECD 401) is available on a read-across source substance ( Glycerides, C12-18 (even numbered) di- and tri- / 91744-28-4 / 294-590-9) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9342de0e-09f3-44a9-bde7-7028ebcccf04/documents/33e9116b-8bb5-4f21-8c04-797eec8dd73d_68450793-7f6a-49fa-bcc1-25328117f96d.html,,,,,, "Glycerides, C12-18 mono-, di- and tri-",91052-53-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9342de0e-09f3-44a9-bde7-7028ebcccf04/documents/33e9116b-8bb5-4f21-8c04-797eec8dd73d_68450793-7f6a-49fa-bcc1-25328117f96d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Glycerides, C14-18",67701-27-3,"Studies on oral repeated dose toxicity were available for the following Category members (CAS No.): 73398-61-5, 8001-79-4, 91845 -19-1 and for medium- and long-chain triglyceride mixtures. All available studies resulted in oral NOAELs of 1000 mg/kg bw/d or greater than 1000 mg/kg bw/d.Studies on dermal repeated dose toxicity were available for the following Category member (CAS No.): 73398-61-5.A subacute (28 days) dermal NOAEL of 2000 mg/kg bw/d for rabbits was reported. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c88788c-03d1-4454-8614-1fd4ddd7cb02/documents/IUC5-62e3c794-fa3c-4442-8aab-7dd2eaf6380c_74b795a4-6086-4012-98b2-f526e192a06d.html,,,,,, "Glycerides, C14-18",67701-27-3,"All available acute toxicity studies within this Category showed that Fatty Acid Glycerides are non-toxic via the oral, dermal or inhalation exposure route. Studies on acute oral toxicity were available for the following members of this category (CAS No.): 31566-31-1, 67701-26-2, 67701-33-1, 73398-61-5, 8001-78-3, 85251-77-0, 91744-13-7 and medium and long chain triglycerols (Matulka, 2006). The acute oral LD50 for rats and mice in all studies was found to be greater than 2000 or 5000 mg/kg bw.Studies on acute dermal toxicity were available for the following members of this category (CAS No.): 91845-19-1, 620-67-7, 555-43-1.The acute dermal LD50 in rats in all studies was found to be greater than 2000 mg/kg bwOne study on acute inhalation toxicity was available for the following member of this category (CAS No.): 73398-61-5.No signs of systemic toxicity occured in male rats upon acute inhalation exposure to the maximum attainable concentration of Triglycerides, mixed decanoyl and octanoyl (CAS No.: 73398-61-5). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c88788c-03d1-4454-8614-1fd4ddd7cb02/documents/IUC5-ebc86b3b-bd18-49e6-8586-032bfc9b18b8_74b795a4-6086-4012-98b2-f526e192a06d.html,,,,,, "Glycerides, C14-18 and C16-18-unsatd. mono-, di- and tri-",91052-28-7,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1cfd2e1-e75c-4224-a36d-2f7e102ec81f/documents/IUC5-74c4c6f9-6d44-4041-a345-db8f3368043f_b5647a70-c958-48d6-8a06-173d7cabf0d5.html,,,,,, "Glycerides, C14-18 and C16-18-unsatd. mono-, di- and tri-",91052-28-7,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1cfd2e1-e75c-4224-a36d-2f7e102ec81f/documents/IUC5-1239fe69-77a2-4aa3-9489-fa1735bae788_b5647a70-c958-48d6-8a06-173d7cabf0d5.html,,,,,, "Glycerides, C14-18 mono- and di-",67701-33-1,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/808dff90-16f1-4313-9e2d-503fe8c91a9a/documents/IUC5-77ffa7ad-0471-4908-ae01-7a9f1f7b68c9_36407690-3363-46b7-a74e-e92d0f67800e.html,,,,,, "Glycerides, C14-18 mono- and di-",67701-33-1,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/808dff90-16f1-4313-9e2d-503fe8c91a9a/documents/IUC5-4d99d770-b1de-4bad-82f3-de2995288abb_36407690-3363-46b7-a74e-e92d0f67800e.html,,,,,, "Glycerides, C16-18 and C18-unsatd. mono-",91744-09-1,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3aef081a-dbd4-4528-8a46-c62bf79d5d6d/documents/IUC5-a7441c24-a9d1-4277-8d42-603d79a6ca69_a3675952-b44a-4195-98b3-ecd39f612a4a.html,,,,,, "Glycerides, C16-18 and C18-unsatd. mono-",91744-09-1,"All available acute toxicity studies within this Category showed that Fatty Acid Glycerides are non-toxic via the oral, dermal or inhalation exposure route. Studies on acute oral toxicity were available for the following members of this category (CAS No.): 31566-31-1, 67701-26-2, 67701-33-1, 73398-61-5, 8001-78-3, 85251-77-0, 91744-13-7 and medium and long chain triglycerols (Matulka, 2006). The acute oral LD50 for rats and mice in all studies was found to be greater than 2000 or 5000 mg/kg bw.Studies on acute dermal toxicity were available for the following members of this category (CAS No.): 91845-19-1, 620-67-7, 555-43-1.The acute dermal LD50 in rats in all studies was found to be greater than 2000 mg/kg bwOne study on acute inhalation toxicity was available for the following member of this category (CAS No.): 73398-61-5.No signs of systemic toxicity occured in male rats upon acute inhalation exposure to the maximum attainable concentration of Triglycerides, mixed decanoyl and octanoyl (CAS No.: 73398-61-5). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3aef081a-dbd4-4528-8a46-c62bf79d5d6d/documents/IUC5-ebc86b3b-bd18-49e6-8586-032bfc9b18b8_a3675952-b44a-4195-98b3-ecd39f612a4a.html,,,,,, "Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates",91052-16-3,"Oral (OECD 408), rat: NOAEL (systemic) ≥ 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36568263-75f6-443e-9d08-13ffabbad2e4/documents/IUC5-c1cd189c-45eb-4666-8b1b-6bd3fbde15cb_b8e41abd-93f8-4008-bdf6-6871ee3f389a.html,,,,,, "Glycerides, C16-18 and C18-unsatd. mono- and di-, citrates",91052-16-3,Oral: LD50 > 2000 mg/kg bw Dermal: LD50 > 2000 mg/kg bwInhalation: no data ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36568263-75f6-443e-9d08-13ffabbad2e4/documents/IUC5-38c648ff-f0ed-40f4-b3b0-03a5dc318640_b8e41abd-93f8-4008-bdf6-6871ee3f389a.html,,,,,, "Glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts",91744-23-9," A 90 day oral feeding study with Castor oil was performed equivalent to OECD Guideline 408 in F344/N rats and B6C3F1 mice. The test substance was mixed at concentrations of 0, 0.62, 1.25, 2.50, 5.00, 10.0 % (w/w) to the diet and the animals (10/sex/concentration) were fed ad libitum for 13 weeks. The highest concentration was equivalent to approximately 5.7 g/kg bw/day for rats and approximately 15 g/kg bw/day for mice. Exposure to castor oil at dietary concentrations as high as 10% in 13-week studies did not affect survival or body weight gains of rats or mice. There were no biologically significant effects noted in hematologic analyses in rats. Mild increases in total bile acids and in serum alkaline phosphatase were noted at various times during the studies in rats receiving the higher dietary concentrations of castor oil. Liver weights were increased in male rats receiving the 10% dietary concentration and in male and female mice receiving diets containing 5% or 10% castor oil. However, there were no histopathologic lesions associated with these liver changes, nor were there any compound-related morphologic changes in any organ in rats or mice. No significant changes were noted in a screening for male reproductive endpoints, including sperm count and motility, and no changes were observed in the length of oestrous cycles of rats or mice given diets containing castor oil. Thus, no significant adverse effects of castor oil administration were noted in these studies. A NOAEL of 5000 mg/kg bw/day for rats and a NOAEL of 15000 mg/kg bw/day for mice could be identified. A 90 day oral feeding study with medium chain triglycerides (MCT,s) was performed similar to OECD 409 in adult beagle dogs. All dogs received on 91 consecutive days approximately 200 g of conventional feed with 0%, 5%, 10%, or 15% MCT for a three hour feeding regimen (4 animals per dose). Based on examination of clinical signs, body weight measurements, food consumption level, physical examinations, haematology and serum chemistry, ophthalmic examinations, and urinalysis the NOAEL for medium chain triglycerides was found to be greater than 15 % , which was calculated to be approximately 3750 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e72eca0-4966-4edc-a038-2b633b96f50f/documents/IUC5-13b6ac37-2d7c-4e1d-98f3-e8a9d01905ce_983b87ae-3696-4613-9f82-a431eafb3312.html,,,,,, "Glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts",91744-23-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3e72eca0-4966-4edc-a038-2b633b96f50f/documents/IUC5-13b6ac37-2d7c-4e1d-98f3-e8a9d01905ce_983b87ae-3696-4613-9f82-a431eafb3312.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat "Glycerides, C16-18 and C18-unsatd. mono-, di- and tri-, citrates, potassium salts",91744-23-9," In an acute oral toxicity study the substance was administered to Sprague-Dawley rats (5 animals/sex/dose) by oral gavage at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was comparable with the control animals and no abnormalities found at macroscopic post-mortem examination. The LD50 is >2000 mg/kg bw and the substance is considered to be practically non-toxic. In an acute dermal toxicity study the substance was administered to rats (5 animals/sex/dose) by dermal application at a dose level of 2000 mg/kg bw (single administration; semi-occlusive). There were no mortalities or signs of clinical toxicity, mean body weight gain was comparable with the control animals and no abnormalities found at macroscopic post-mortem examination.The LD50 is >2000 mg/kg bw and the substance is considered to be practically non-toxic. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3e72eca0-4966-4edc-a038-2b633b96f50f/documents/IUC5-ce4c6259-d5ec-4fd2-8303-184262e78864_983b87ae-3696-4613-9f82-a431eafb3312.html,,,,,, "Glycerides, C16-18 mono-",91052-47-0,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f28cecca-25c7-49fd-919e-760e38437fcf/documents/199c0500-2217-49a1-9375-fa09fe0d39bb_7e74297c-38dd-4505-bc2f-356890d69d05.html,,,,,, "Glycerides, C16-18 mono-",91052-47-0,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f28cecca-25c7-49fd-919e-760e38437fcf/documents/4d2a6d0a-1a08-4942-b900-c2fc6e6bf6bb_7e74297c-38dd-4505-bc2f-356890d69d05.html,,,,,, "Glycerides, C16-18 mono- and di-",85251-77-0,"Studies on oral repeated dose toxicity were available for the following Category members (CAS No.): 73398-61-5, 8001-79-4, 91845 -19-1 and for medium- and long-chain triglyceride mixtures. All available studies resulted in oral NOAELs of 1000 mg/kg bw/d or greater than 1000 mg/kg bw/d.Studies on dermal repeated dose toxicity were available for the following Category member (CAS No.): 73398-61-5.A subacute (28 days) dermal NOAEL of 2000 mg/kg bw/d for rabbits was reported. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3d41d39-9c0f-47a9-aa69-a88a182ae6f3/documents/IUC5-89ee4d25-0de7-4c0c-b700-750c5b3872ea_cf569eb1-af18-4ebe-b333-7c1f3cbd8e10.html,,,,,, "Glycerides, C16-18 mono- and di-",85251-77-0,"All available acute toxicity studies within this Category showed that Fatty Acid Glycerides are non-toxic via the oral, dermal or inhalation exposure route. Studies on acute oral toxicity were available for the following members of this category (CAS No.): 31566-31-1, 67701-26-2, 67701-33-1, 73398-61-5, 8001-78-3, 85251-77-0, 91744-13-7 and medium and long chain triglycerols (Matulka, 2006). The acute oral LD50 for rats and mice in all studies was found to be greater than 2000 or 5000 mg/kg bw.Studies on acute dermal toxicity were available for the following members of this category (CAS No.): 91845-19-1, 620-67-7, 555-43-1.The acute dermal LD50 in rats in all studies was found to be greater than 2000 mg/kg bwOne study on acute inhalation toxicity was available for the following member of this category (CAS No.): 73398-61-5.No signs of systemic toxicity occured in male rats upon acute inhalation exposure to the maximum attainable concentration of Triglycerides, mixed decanoyl and octanoyl (CAS No.: 73398-61-5). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3d41d39-9c0f-47a9-aa69-a88a182ae6f3/documents/IUC5-e48e92af-5733-40d8-ab96-59cc97de2d8a_cf569eb1-af18-4ebe-b333-7c1f3cbd8e10.html,,,,,, "Glycerides, C16-18 mono-, di- and tri-",91052-54-9,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/27c6b425-664f-4a22-9501-3ff50e3f6b46/documents/IUC5-100d09c9-bec5-46ea-87dd-82f55c82d3ca_588c740e-7aba-41cf-aec0-c5836812f08c.html,,,,,, "Glycerides, C16-18 mono-, di- and tri-",91052-54-9,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27c6b425-664f-4a22-9501-3ff50e3f6b46/documents/IUC5-694f4908-af3e-4729-afa2-3635b21d3d49_588c740e-7aba-41cf-aec0-c5836812f08c.html,,,,,, "Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts",91744-38-6,"Studies on oral repeated dose toxicity were available for castor oil, medium-chain triglyceride mixtures, and acetoglycerides. All available studies resulted in oral NOAELs of 1000 mg/kg bw/d or greater than 1000 mg/kg bw/d. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c9f5188-63c9-4d3b-a996-289d04e67175/documents/IUC5-4c267779-0453-40c5-8670-eaf19f466359_ed205c2a-9606-4bc5-9c28-9dd39f1fdcdb.html,,,,,, "Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts",91744-38-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c9f5188-63c9-4d3b-a996-289d04e67175/documents/IUC5-4c267779-0453-40c5-8670-eaf19f466359_ed205c2a-9606-4bc5-9c28-9dd39f1fdcdb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat "Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, potassium salts",91744-38-6,"OECD 401/OECD 402, conducted with a similar substance. Both tests were conducted at a limit dose of 2000 mg/kg bw. None of the test animals died or showed sublethal effects. As no data are available for CAS 91744-39-7 (Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, sodium salts), the available data for the analogue substance CAS 91744-23-9 are used in a read-across approach. For details please refer to the read-across report. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c9f5188-63c9-4d3b-a996-289d04e67175/documents/IUC5-a22ba24c-2683-4eaa-967e-726981bdb160_ed205c2a-9606-4bc5-9c28-9dd39f1fdcdb.html,,,,,, "Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, sodium salts",91744-39-7,"Studies on oral repeated dose toxicity were available for castor oil, medium-chain triglyceride mixtures, and acetoglycerides. All available studies resulted in oral NOAELs of 1000 mg/kg bw/d or greater than 1000 mg/kg bw/d. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/976322b4-606c-4b73-9ba3-45d268114d32/documents/IUC5-6c49353c-6741-4b77-8983-d26fabb38a5c_f545472a-2b9c-4f56-a6ce-154f9e50cea0.html,,,,,, "Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, sodium salts",91744-39-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/976322b4-606c-4b73-9ba3-45d268114d32/documents/IUC5-6c49353c-6741-4b77-8983-d26fabb38a5c_f545472a-2b9c-4f56-a6ce-154f9e50cea0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"5,000 mg/kg bw/day",,rat "Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, sodium salts",91744-39-7,"OECD 401/OECD 402, conducted with a similar substance. Both tests were conducted at a limit dose of 2000 mg/kg bw. None of the test animals died or showed sublethal effects. As no data are available for CAS 91744-39-7 (Glycerides, C16-18 mono-, di- and tri-, hydrogenated, citrates, sodium salts), the available data for the analogue substance CAS 91744-23-9 are used in a read-across approach. For details please refer to the read-across report. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/976322b4-606c-4b73-9ba3-45d268114d32/documents/IUC5-69625495-51e4-445d-9e7e-4768d9c8ae5c_f545472a-2b9c-4f56-a6ce-154f9e50cea0.html,,,,,, "Glycerides, C16-22",68002-70-0,"Oral NOAEL for risk assessment purposes: 7.5% in feed, equivalent to an estimated 3,750 mg/kg bw/day. Dermal exposure is lower than oral due to lower penetration (10 versus up to 17%).No significant respiratory exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/202fd41f-434a-4c4b-9531-dd495d8255e2/documents/d73c2a8d-2f6d-44ff-84f9-b41bd1e9735f_1d2c2542-dee5-4b57-905f-93dec3007744.html,,,,,, "Glycerides, C16-22",68002-70-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/202fd41f-434a-4c4b-9531-dd495d8255e2/documents/d73c2a8d-2f6d-44ff-84f9-b41bd1e9735f_1d2c2542-dee5-4b57-905f-93dec3007744.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,750 mg/kg bw/day",,rat "Glycerides, C16-22",68002-70-0,"Based on data for substrances of the same read-across category, acute oral LD50 > 4,000 mg/kg bw/day; acute dermal LD50 > 3,000 mg/kg bw/day; no significant inhalatory exposure ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/202fd41f-434a-4c4b-9531-dd495d8255e2/documents/964e2086-07b1-47bd-a0dd-3a00031d5907_1d2c2542-dee5-4b57-905f-93dec3007744.html,,,,,, "Glycerides, C16-22",68002-70-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/202fd41f-434a-4c4b-9531-dd495d8255e2/documents/964e2086-07b1-47bd-a0dd-3a00031d5907_1d2c2542-dee5-4b57-905f-93dec3007744.html,,oral,LD50,"4,000 mg/kg bw",, "Glycerides, C16-22",68002-70-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/202fd41f-434a-4c4b-9531-dd495d8255e2/documents/964e2086-07b1-47bd-a0dd-3a00031d5907_1d2c2542-dee5-4b57-905f-93dec3007744.html,,dermal,LD50,"3,000 mg/kg bw",, "Glycerides, C8-10 mono- and di-",85536-07-8,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10fa7d40-2d80-4255-b884-98f5d74b11a0/documents/IUC5-2c9adc64-e173-48cf-8e12-76edf5134ffb_ae1ecbf2-ffad-4eb9-8606-2cf2eaa238f5.html,,,,,, "Glycerides, C8-10 mono- and di-",85536-07-8,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10fa7d40-2d80-4255-b884-98f5d74b11a0/documents/IUC5-896d25ac-f3a7-4705-873a-38b3b225425d_ae1ecbf2-ffad-4eb9-8606-2cf2eaa238f5.html,,,,,, "Glycerides, C8-18",85536-06-7,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6241a22-d3ed-407c-8cd3-3c3c37ce5809/documents/IUC5-58371142-ad75-4807-a1cf-85b31d25b746_b02262f4-3e87-448a-ae25-e6d59c99efa7.html,,,,,, "Glycerides, C8-18",85536-06-7,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6241a22-d3ed-407c-8cd3-3c3c37ce5809/documents/IUC5-2a628b77-f471-40a9-b7e0-47d0bac06ff5_b02262f4-3e87-448a-ae25-e6d59c99efa7.html,,,,,, "Glycerides, C8-18 and C18-unsatd.",67701-28-4,"Oral NOAEL for risk assessment purposes: 18.5% in feed, equivalent to an estimated 9,250 mg/kg bw/day. Dermal exposure is lower than oral due to lower penetration (10 versus up to 96%).No significant respiratory exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/420abe0d-beb7-449b-ae35-d0a48a2dc129/documents/IUC5-2383df53-17d8-4283-b130-0577f7a564d7_ca811526-9ddb-4893-88ba-654d903a37ae.html,,,,,, "Glycerides, C8-18 and C18-unsatd.",67701-28-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/420abe0d-beb7-449b-ae35-d0a48a2dc129/documents/IUC5-2383df53-17d8-4283-b130-0577f7a564d7_ca811526-9ddb-4893-88ba-654d903a37ae.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"9,250 mg/kg bw/day",,rat "Glycerides, C8-18 and C18-unsatd.",67701-28-4,"Acute oral LD50 > 5,000 mg/kg bw/day; acute dermal LD50 > 3,000 mg/kg bw/day; no significant inhalatory exposure ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/420abe0d-beb7-449b-ae35-d0a48a2dc129/documents/IUC5-d6ba8cd7-738a-4be7-a261-8dbea1b287de_ca811526-9ddb-4893-88ba-654d903a37ae.html,,,,,, "Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates",91052-13-0,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eee2ffee-818a-4b53-bda5-aaa45a114fbc/documents/IUC5-362f6e42-fe39-4320-aade-ad802fe9ab72_9a63be8b-8bff-4a5c-94aa-0c0c97d1fbee.html,,,,,, "Glycerides, C8-18 and C18-unsatd. mono- and di-, acetates",91052-13-0,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eee2ffee-818a-4b53-bda5-aaa45a114fbc/documents/IUC5-6b43d280-46c4-42c0-bfa5-e33ee58e8cb4_9a63be8b-8bff-4a5c-94aa-0c0c97d1fbee.html,,,,,, "Glycerides, castor-oil mono-, di- and tri-",91744-27-3," No adverse effect observed; NOAEL = 1000 mg/kg bw/d (OECD 422, GLP, rat, oral route) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7633ebcd-5115-4510-81eb-46d2ebe738a0/documents/5a4d4654-8d12-4422-ba38-79c314110d43_fd7c70b3-e50b-4286-a3ee-a81aef7fbeac.html,,,,,, "Glycerides, castor-oil mono-, di- and tri-",91744-27-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7633ebcd-5115-4510-81eb-46d2ebe738a0/documents/5a4d4654-8d12-4422-ba38-79c314110d43_fd7c70b3-e50b-4286-a3ee-a81aef7fbeac.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Glycerides, castor-oil mono-, di- and tri-",91744-27-3," Acute oral toxicity: A study, similar to OECD401 was performed with the read-across substance CAS 91744-44-4: LD50> 5000 mg/kg bw Acute dermal toxicity: OECD402: LD50> 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7633ebcd-5115-4510-81eb-46d2ebe738a0/documents/3f0e7cbe-5838-4265-bd7f-ef5f43b6f231_fd7c70b3-e50b-4286-a3ee-a81aef7fbeac.html,,,,,, "Glycerides, castor-oil mono-, di- and tri-",91744-27-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7633ebcd-5115-4510-81eb-46d2ebe738a0/documents/3f0e7cbe-5838-4265-bd7f-ef5f43b6f231_fd7c70b3-e50b-4286-a3ee-a81aef7fbeac.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Glycerides, castor-oil mono-, di- and tri-",91744-27-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7633ebcd-5115-4510-81eb-46d2ebe738a0/documents/3f0e7cbe-5838-4265-bd7f-ef5f43b6f231_fd7c70b3-e50b-4286-a3ee-a81aef7fbeac.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Glycerides, mixed C8-10 and succinyl",91744-56-8,"Based on read-across from glycerides and succinic acid (and its sodium salts) and in a weight of evidence approach, no hazard was identified.Oral: chronic NOAEL (rat, male) = 3930 mg/kg bw/day (based on read-across from sodium hydrogen succinate and after correction for differences in molecular weight and succinic acid content) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60d235b1-32c9-4c60-b09b-2a1d7cc36a69/documents/IUC5-1d870129-e294-4298-96ed-49f7a9d7423d_1a509780-ff0e-45d9-bc25-9229042bcac8.html,,,,,, "Glycerides, mixed C8-10 and succinyl",91744-56-8,"Oral LD50 > 5000 mg/kg bwDermal LD50 > 5000 mg/kg bwInhalation: LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles; based on read-across from Glycerides, mixed decanoyl and octanoyl) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60d235b1-32c9-4c60-b09b-2a1d7cc36a69/documents/IUC5-ad87832e-3414-4e95-9515-fe14362d4d25_1a509780-ff0e-45d9-bc25-9229042bcac8.html,,,,,, "Glycerides, mixed coco, decanoyl and octanoyl",68606-18-8,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d787a70e-4291-43cd-892e-ed8c46f3f629/documents/IUC5-f7733722-268b-4249-a7d8-8ec604c23ffa_38690603-7d23-4838-a890-08838f757870.html,,,,,, "Glycerides, mixed coco, decanoyl and octanoyl",68606-18-8,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d787a70e-4291-43cd-892e-ed8c46f3f629/documents/IUC5-3ea117b1-eeb6-4990-b5e7-d66bacd34ed2_38690603-7d23-4838-a890-08838f757870.html,,,,,, "Glycerides, palm-oil mono- and di-, hydrogenated",67784-87-6,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c2ae627-10c7-4952-8c38-b9eca88787a5/documents/IUC5-eff59e8b-5cc9-4da7-845d-573f9af23a25_4fbf7259-bb45-4ef8-9f5f-4d1e818e8cfb.html,,,,,, "Glycerides, palm-oil mono- and di-, hydrogenated",67784-87-6,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c2ae627-10c7-4952-8c38-b9eca88787a5/documents/IUC5-797a830b-f89f-4d1d-ba0e-c5efa61682a0_4fbf7259-bb45-4ef8-9f5f-4d1e818e8cfb.html,,,,,, "Glycerides, palm-oil mono-, hydrogenated, acetates",93572-32-8,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfb69c5b-bfb2-416f-a5a6-3d8590222936/documents/IUC5-100d09c9-bec5-46ea-87dd-82f55c82d3ca_7997ea85-dacd-4bd1-a037-f4bea88656aa.html,,,,,, "Glycerides, palm-oil mono-, hydrogenated, acetates",93572-32-8,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfb69c5b-bfb2-416f-a5a6-3d8590222936/documents/IUC5-694f4908-af3e-4729-afa2-3635b21d3d49_7997ea85-dacd-4bd1-a037-f4bea88656aa.html,,,,,, "Glycerides, tall-oil mono-",61789-12-6, Acute Toxicity: Oral The LD50 of the test item LUMULSE GMT-K is greater than 2000 mg/kg body weight after single oral administration to Wistar rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5200c5b5-96e6-4230-a4ae-2b17b5b36496/documents/ae20333b-a39b-4090-9df5-a54b857987ae_d468b94a-62bb-4c7f-9c87-f726833f4a25.html,,,,,, "Glycerides, tall-oil mono-",61789-12-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5200c5b5-96e6-4230-a4ae-2b17b5b36496/documents/ae20333b-a39b-4090-9df5-a54b857987ae_d468b94a-62bb-4c7f-9c87-f726833f4a25.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Glycerides, tallow sesqui-, hydrogenated, propoxylated",68553-12-8," In a reliable repeated dose oral toxicity study in rats (Wistar, OECD TG 407), a structurally similar substance was adiministered via gavage to 5 rats/sex/dose at 0, 100, 300, 1000 mg/kg bw for 4 weeks. No death was observed in either sex. No clinical effects were observed in both sex of all dose groups.There was no effect observed upon haematological, clinical biochemistry or macroscopic examination at any dose that could be ascribed to the substance. Based on these results the NOAEL was considered to be 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d016ffe6-dbd5-4d53-9268-738f327c4c83/documents/f8db61ad-8fd6-4aa1-b2e8-0b39d1048d76_83575e41-3423-48f5-b2ee-f79f5c92db1b.html,,,,,, "Glycerides, tallow sesqui-, hydrogenated, propoxylated",68553-12-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d016ffe6-dbd5-4d53-9268-738f327c4c83/documents/f8db61ad-8fd6-4aa1-b2e8-0b39d1048d76_83575e41-3423-48f5-b2ee-f79f5c92db1b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Glycerides, tallow sesqui-, hydrogenated, propoxylated",68553-12-8, In a reliable acute toxicity study the substance was administered to Sprague Dawley rats (5 animals/sex/dose) by oral gavage at a dose level of 2000 mg/kg bw (single administration). The oral LD50 is >2000 mg/kg bw. In a second reliable acute oral toxicity study the substance was administered to rats (5 animals/sex/dose) by oral gavage at a dose level of 10000 mg/kg bw (single administration). The LD50 is 10000 mg/kg bw. In a reliable acute toxicity study a structurally similar substance was administered to Sprague Dawley rats (6 animals) by oral gavage at a dose level of 2000 mg/kg bw (single administration). The oral LD50 is >2500 mg/kg bw. In a reliable acute toxicity study a structurally similar substance was administered to Sprague Dawley rats (5 animals/sex) by semi-occluded dermal application for 24 hours at a dose level of 2000 mg/kg bw (single administration). The dermal LD50 is >2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d016ffe6-dbd5-4d53-9268-738f327c4c83/documents/67ccac00-ffe4-4f41-b9ca-3715c9ccc80a_83575e41-3423-48f5-b2ee-f79f5c92db1b.html,,,,,, "Glycerides, tallow sesqui-, hydrogenated, propoxylated",68553-12-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d016ffe6-dbd5-4d53-9268-738f327c4c83/documents/67ccac00-ffe4-4f41-b9ca-3715c9ccc80a_83575e41-3423-48f5-b2ee-f79f5c92db1b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Glycerides, tallow sesqui-, hydrogenated, propoxylated",68553-12-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d016ffe6-dbd5-4d53-9268-738f327c4c83/documents/67ccac00-ffe4-4f41-b9ca-3715c9ccc80a_83575e41-3423-48f5-b2ee-f79f5c92db1b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Glycerol, ethoxylated, esters with acrylic acid",144086-03-3,"Oral:- NOAEL (local iritation effects) = 50 mg/kg bw/day (Wistar rat, OECD TG 422, 30 (males) - 49 (females) days, gavage)- NOAEL (general, systemic toxicity) = 150 mg/kg bw/day (Wistar rat, OECD TG 422, 30 (males) - 49 (females) days, gavage)Dermal:- no dataInhalation:- no data ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/63eb4e22-2ae0-43e5-a400-35299eae0bda/documents/IUC5-358bc6ce-9b14-4143-930e-4386107426aa_4c14e7fb-5cfb-4852-9e85-d93025194726.html,,,,,, "Glycerol, ethoxylated, esters with acrylic acid",144086-03-3,"OralRat: LD50 >300 and <2000 mg/kg bw (comp. OECD 401; BASF AG 2005)InhalationRat: LC50 = 0.541 mg/L (accord. OECD 403, aerosol; BASF SE 2010)DermalThere are no data available. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63eb4e22-2ae0-43e5-a400-35299eae0bda/documents/IUC5-d64ecc43-d437-4358-93e7-edb6e91ebd63_4c14e7fb-5cfb-4852-9e85-d93025194726.html,,,,,, "Glycerol, propoxylated, esters with acrylic acid, reaction products with diethylamine",162492-10-6,"A combined 28-day repeated toxicity and reproduction screening test is available in rats. Based on the experimental conditions and results of this study, the No Observed Adverse Effect Level (NOAEL) for parental toxicity (systemic and local) was considered to be 300 mg/kg/day, based on the two deaths and the loud breathing present in most animals at 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d358b3bd-4998-4f15-bc6f-70b0de2de242/documents/IUC5-63d60b60-20d1-43ba-ab44-d4b781b379f2_c933061f-1470-4ecc-befd-7df433323efb.html,,,,,, "Glycerol, propoxylated, esters with acrylic acid, reaction products with diethylamine",162492-10-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d358b3bd-4998-4f15-bc6f-70b0de2de242/documents/IUC5-63d60b60-20d1-43ba-ab44-d4b781b379f2_c933061f-1470-4ecc-befd-7df433323efb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Glycerol, propoxylated, esters with acrylic acid, reaction products with diethylamine",162492-10-6,"The acute toxicity potential of Glycerol, propoxylated, esters with acrylic acid, reaction products with diethylamine was evaluated in an oral acute test performed on rat. No mortality was observed in this study, the LD50 is also considered to be higher than 2000 mg/kg/d. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d358b3bd-4998-4f15-bc6f-70b0de2de242/documents/IUC5-25a4e095-cc2c-48c7-a936-41e6172d5b1b_c933061f-1470-4ecc-befd-7df433323efb.html,,,,,, "Glycerol, propoxylated, esters with acrylic acid, reaction products with diethylamine",162492-10-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d358b3bd-4998-4f15-bc6f-70b0de2de242/documents/IUC5-25a4e095-cc2c-48c7-a936-41e6172d5b1b_c933061f-1470-4ecc-befd-7df433323efb.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "dimethyl 2,2'-({5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)diazenyl]-2-methoxyphenyl}imino)diacetate",88938-51-6,"Based on the findings in the non-glandular stomach in the combined repeat-dose/developmental screening study, the NOAEL (No Observed Adverse Effect Level) in rats for local effects was considered to be 250 mg/kg body weight/day. Due to the fact that the histopathological findings observed in the non- glandular region of the stomach are a local reaction due to the test material overload, the NOAEL for systemic effects was considered to be 1000 mg/kg body weight/day for male and female rats. However, as humans do not possess a non-glandular stomach, this finding is not relevant for humans and consequently for the risk assessment. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d12c7fef-925f-4bce-93a7-7530dd122e41/documents/IUC5-5b4b3e79-6d66-405e-bb4e-d882486f222f_03f7b573-732b-41e2-9814-052b2d39b4f1.html,,,,,, "dimethyl 2,2'-({5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)diazenyl]-2-methoxyphenyl}imino)diacetate",88938-51-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d12c7fef-925f-4bce-93a7-7530dd122e41/documents/IUC5-5b4b3e79-6d66-405e-bb4e-d882486f222f_03f7b573-732b-41e2-9814-052b2d39b4f1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "dimethyl 2,2'-({5-acetamido-4-[(2-bromo-4,6-dinitrophenyl)diazenyl]-2-methoxyphenyl}imino)diacetate",88938-51-6,"Disperse Blue ANT, did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d12c7fef-925f-4bce-93a7-7530dd122e41/documents/IUC5-7dfaaf53-78ce-497e-bcad-610742eae291_03f7b573-732b-41e2-9814-052b2d39b4f1.html,,,,,, "3-Methoxy-18-methyl-1,3,5(10)-estratrien-17 beta-ol",3625-82-9,"LD50 oral (rat): > 2000 mg/kg bw [report No. A11270, Wick 2004]LD50 dermal (rat): > 2000 mg/kg bw [report No. 11076, Döhr 2004] ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ea00aa6-48eb-4ad5-ba18-3b95bf334277/documents/IUC5-f85b9e9d-5999-4e39-bc44-d585bebae967_62d76e13-5c02-4c62-b1cb-c4e2ae409988.html,,,,,, "3-Methoxy-18-methyl-1,3,5(10)-estratrien-17 beta-ol",3625-82-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ea00aa6-48eb-4ad5-ba18-3b95bf334277/documents/IUC5-f85b9e9d-5999-4e39-bc44-d585bebae967_62d76e13-5c02-4c62-b1cb-c4e2ae409988.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3-Methoxy-18-methyl-1,3,5(10)-estratrien-17 beta-ol",3625-82-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ea00aa6-48eb-4ad5-ba18-3b95bf334277/documents/IUC5-f85b9e9d-5999-4e39-bc44-d585bebae967_62d76e13-5c02-4c62-b1cb-c4e2ae409988.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Graphene,1034343-98-0,"Key: repeated dose, inhalation, 28 d, rat, accoding to OECD 412, NOAEC ≥ 1.88 mg/m3 (Kim et al., 2016) Supp: repeated dose, inhalation, 28 d, rat, similar to OECD 412, NOAEC ≥ 10 mg/m3 (Ma-Hock et al., 2013) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/773b6b72-b879-47fb-b8be-78cbd4233b46/documents/fad510f2-69cd-4e66-bba0-840996eda8df_da4d33ec-964d-4856-a90b-5b36cc99b648.html,,,,,, Graphene,1034343-98-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/773b6b72-b879-47fb-b8be-78cbd4233b46/documents/fad510f2-69cd-4e66-bba0-840996eda8df_da4d33ec-964d-4856-a90b-5b36cc99b648.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,>= 1.88 mg/m3,,rat Graphene,1034343-98-0,"Oral: Key, acute fixed dose method comparable to OECD TG 420, mouse 5000 mg/kg bw, single dose (gavage): LD50 > 2000 mg/kg bw (Mingjing, 2015) Inhalation: Key, acute toxicity class method according to OECD TG 436, GLP, rat, single dose (inhalation): LC50 > 1.99 mg/L (the max. achieved aerosol concentration) (Zabaiou, 2020) Dermal: no study required (Waiver) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/773b6b72-b879-47fb-b8be-78cbd4233b46/documents/2c97bdd9-db1d-46dd-b1b5-b554c1d73a46_da4d33ec-964d-4856-a90b-5b36cc99b648.html,,,,,, Graphene,1034343-98-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/773b6b72-b879-47fb-b8be-78cbd4233b46/documents/2c97bdd9-db1d-46dd-b1b5-b554c1d73a46_da4d33ec-964d-4856-a90b-5b36cc99b648.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Graphene,1034343-98-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/773b6b72-b879-47fb-b8be-78cbd4233b46/documents/2c97bdd9-db1d-46dd-b1b5-b554c1d73a46_da4d33ec-964d-4856-a90b-5b36cc99b648.html,,inhalation,LC50,"1,990 mg/m3",no adverse effect observed, Graphite,7782-42-5," In a combined repeated dose toxicity study with reproduction/developmental toxicity screening test via the oral (dietary) route (OECD TG 422), there were no systemic adverse effects observed up to nominal exposure levels corresponding to the maximum recommended dose of 1000 mg/kg bw/day. In two sub-acute repeated dose toxicity studies via the inhalation route (OECD TG 412), Synthetic Graphite (SG; w/o Quartz) and Expanded Graphite (EG; with Quartz) were tested individually. In both studies, exposure was generally well tolerated and there were no signs of systemic toxicity. Both graphite qualities showed local responses in the respiratory tract with partly recovery after 28 days, that were to be expected for a poorly soluble dust with low toxicity. Testing of SG resulted in a NOAEC of 12 mg/m³ (LOAEC = 36 mg/m³), whereas testing of EG resulted in a NOAEC of 8 mg/m³ (LOAEC = 24 mg/m³). An additional sub-chronic repeated dose toxicity study via the inhalation route (OECD TG 413) with expanded graphite did not show systemic effects after treatment with the test item. Local responses were observed in the respiratory tract at all doses investigated, which were in line with effects expected for poorly soluble particles with low toxicity. No NOAEL could be derived for local responses in the respiratory tract, the local LOAEC was 3.20 mg/m³. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0a23c21-7729-4905-9169-600b4b43c637/documents/fb50fe06-1cc6-4f41-9937-af439b382b38_57ec6488-7d8d-4836-a2bc-7ffd8acc9eb3.html,,,,,, Graphite,7782-42-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0a23c21-7729-4905-9169-600b4b43c637/documents/fb50fe06-1cc6-4f41-9937-af439b382b38_57ec6488-7d8d-4836-a2bc-7ffd8acc9eb3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,813 mg/kg bw/day,,rat Graphite,7782-42-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0a23c21-7729-4905-9169-600b4b43c637/documents/fb50fe06-1cc6-4f41-9937-af439b382b38_57ec6488-7d8d-4836-a2bc-7ffd8acc9eb3.html,Repeated dose toxicity – local effects,inhalation,LOAEC,3.2 mg/m3,adverse effect observed,rat Graphite,7782-42-5,"Acute toxicity: oral- OECD 423, conducted as limit test- None of the animals showed any clinical signs of reaction to the treatment. - LD50 > 2000mg/kg bwAcute toxicity: inhalation- OECD 403, conducted as limit test- Upon cessation of exposure via inhalation none of the rats exposed to Graphite showed any signs of toxicity. - Only usual signs of discomfort after exposure to particles were observed. Grooming activity started immediately after the end of exposure.- LC50 > 2000mg/m3 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0a23c21-7729-4905-9169-600b4b43c637/documents/2ff433c6-3502-45cc-8ad2-ec3a30c03d4d_57ec6488-7d8d-4836-a2bc-7ffd8acc9eb3.html,,,,,, Graphite,7782-42-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0a23c21-7729-4905-9169-600b4b43c637/documents/2ff433c6-3502-45cc-8ad2-ec3a30c03d4d_57ec6488-7d8d-4836-a2bc-7ffd8acc9eb3.html,,oral,LD50,"2,000 mg/kg bw",, Graphite,7782-42-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0a23c21-7729-4905-9169-600b4b43c637/documents/2ff433c6-3502-45cc-8ad2-ec3a30c03d4d_57ec6488-7d8d-4836-a2bc-7ffd8acc9eb3.html,,inhalation,LC50,"2,000 mg/m3",, Guanidinium nitrate,506-93-4, A No Observed Adverse Effect Level (NOAEL) of 100 mg/kg body weight/day for repeated dose toxicity was established from an oral subchronic toxicity study according to OECD guideline 408 with the read-across substance Guanidine hydrochloride. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/340dee8f-de68-488e-a4fa-55ad6122f37c/documents/IUC5-da7d9bc6-f4b6-4d6f-a4a7-03b2de4a6269_c9454fb9-21f5-4a56-80f4-468b86bd4c0d.html,,,,,, Guanidinium nitrate,506-93-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/340dee8f-de68-488e-a4fa-55ad6122f37c/documents/IUC5-da7d9bc6-f4b6-4d6f-a4a7-03b2de4a6269_c9454fb9-21f5-4a56-80f4-468b86bd4c0d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Guanidinium nitrate,506-93-4," Acute toxicity data on Guanidine Nitrate are available for the oral, inhalation and dermal route. The data available from three studies for the oral route all indicate LD50 values in the range between 300 and 2000 mg/kg body weight. For the dermal route, the LD50 is > 2000 mg/kg body weight. In an inhalation study it was shown that at the highest technically achievable dose of 0.853 mg/L air no mortalities occurred. Additional data from an acute inhalation toxicity study with the read-across substance guanidine hydrochloride are available, with a LC50 value for females of 3.181 mg/L air. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/340dee8f-de68-488e-a4fa-55ad6122f37c/documents/IUC5-9221c957-08aa-48cb-ba4d-c62ca793e772_c9454fb9-21f5-4a56-80f4-468b86bd4c0d.html,,,,,, Guanidinium nitrate,506-93-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/340dee8f-de68-488e-a4fa-55ad6122f37c/documents/IUC5-9221c957-08aa-48cb-ba4d-c62ca793e772_c9454fb9-21f5-4a56-80f4-468b86bd4c0d.html,,oral,LD50,729.3 mg/kg bw,adverse effect observed, Guanidinium nitrate,506-93-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/340dee8f-de68-488e-a4fa-55ad6122f37c/documents/IUC5-9221c957-08aa-48cb-ba4d-c62ca793e772_c9454fb9-21f5-4a56-80f4-468b86bd4c0d.html,,inhalation,LC50,"3,181 mg/m3",no adverse effect observed, Guanidinium thiocyanate,593-84-0," Data from two oral sub-chronic toxicity studies in rats, from the read-across substances Guanidinium Hydrochloride and Ammonium Thiocyanate were used to assess repeated dose toxicity of Guanidine Thiocyanate. Reflecting differences in molecular weight between the source substance Ammonium thiocyanate and the target substance Guanidine Thiocyanate a factor of 1.55 was applied to the NOAEL 20 mg/kg bw/d obtained from a sub-chronic toxicity study with Ammonium Thiocyanate resulting in a NOAEL of 31 mg/kg bw/d, which is used for derivation of Guanidine Thiocyanate DNELs. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5cb13e2-c07a-41f9-a2e5-b5c800b30be8/documents/000695bf-db31-4831-b512-040af54d4bd2_a35e32b5-b415-4279-ae51-14c165d35ee7.html,,,,,, Guanidinium thiocyanate,593-84-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5cb13e2-c07a-41f9-a2e5-b5c800b30be8/documents/000695bf-db31-4831-b512-040af54d4bd2_a35e32b5-b415-4279-ae51-14c165d35ee7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,31 mg/kg bw/day,,rat Guanidinium thiocyanate,593-84-0," In an acute oral toxicity study according to OECD guideline 401 with Guanidine Thiocyanate in Sprague Dawley rats, three groups of five fasted female animals were given a single oral dose of test material, in distilled water at dose levels of 354, 500 and 707 mg/kg bodyweight. A further group of five fasted males was similarly treated, at a dose level of 354 mg/kg bodyweight, to confirm that this sex was not markedly more sensitive to the test material. The surviving animals were observed for fourteen days after the day of dosing. All animals were subjected to gross pathological examination.   Oral LD50 Females = 593 mg/kg bw (95% C.I. 431 - 816) Oral LD0 Males = 354 mg/kg bw   Deaths were noted during the day of dosing at 500 and 707 mg/kg bw. Clinical observations noted were ataxia, clonic convulsions, pallor of the extremities, hunched posture, lethargy, piloerection, ptosis, decreased respiratory rate, gasping, laboured and noisy respiration, increased salivation, staining around the mouth and snout and splayed or tiptoe gait. Surviving animals recovered one to three days after dosing except for male animals treated with 354 mg/kg which appeared normal throughout the study. Surviving animals showed expected gain in bodyweight during the study.   Abnormalities noted at necropsy of animals that died during the study were haemorrhagic lungs, dark liver, dark kidneys and haemorrhagic gastric mucosa. No abnormalities were noted at necropsy of animals that were killed at the end of the study.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5cb13e2-c07a-41f9-a2e5-b5c800b30be8/documents/d3f1a328-e964-43f5-b6dc-7b00a1ae779e_a35e32b5-b415-4279-ae51-14c165d35ee7.html,,,,,, Guanidinium thiocyanate,593-84-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5cb13e2-c07a-41f9-a2e5-b5c800b30be8/documents/d3f1a328-e964-43f5-b6dc-7b00a1ae779e_a35e32b5-b415-4279-ae51-14c165d35ee7.html,,oral,LD50,354 mg/kg bw,adverse effect observed, Hafnium,7440-58-6,"As Hf powder is pyrophoric, it is technically not possible to generate an inhalable test atmosphere even for long term studies. The evaluation of repeated dose toxicity inhalation of Hf powder may not be technically possible.Based on the same behaviour and toxicological effects, a read across with ZrO2 is performed. No effect was observed following repeated inhalation of ZrO2. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0c2e5e5-2c73-41ad-8ee3-d9d3e0f9ab51/documents/IUC5-03228309-d48d-4987-b53c-0c567b758736_c9b25199-c362-426e-9da6-37868c8e060b.html,,,,,, Hafnium,7440-58-6,"One study is available for acute toxicity via the oral route of exposure (according to OECD 423): the LD50 is > 2000 mg/kg (rat).No reliable data is available for acute toxicity via the inhalation route of exposure. As Hf powder is pyrophoric, it is not technically possible to generate an inhalable test atmosphere. Based on the same behaviour and toxicological effects, a read across with ZrO2 is performed. No toxic effect is observed in the available study, the LC50 is therefore > 4.3 mgZrO2/L or >3.18 mg eq Zr/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0c2e5e5-2c73-41ad-8ee3-d9d3e0f9ab51/documents/IUC5-da0764b0-fe32-402c-96df-36650fb91a79_c9b25199-c362-426e-9da6-37868c8e060b.html,,,,,, Hafnium dioxide,12055-23-1,"Based on the same behaviour and toxicological effects, a read across with ZrO2 is performed. No effect was observed following repeated inhalation of ZrO2. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f871d996-c143-46fb-8769-bb46fb93590a/documents/IUC5-6cd23af2-f7ac-4eea-b9b0-548368e8d88f_574fb42e-96fb-4c18-9a9a-25b55e5e6ae8.html,,,,,, Hafnium dioxide,12055-23-1,"One study is available for acute toxicity via the oral route of exposure (according to OECD 423): the LD50 is > 2000 mg/kg (rat).No reliable data is available for acute toxicity via the inhalation route of exposure. Based on the same behaviour and toxicological effects, a read across with ZrO2 is performed. No toxic effect is observed in the available study, the LC50 is therefore > 4.3 mg ZrO2/L or >3.18 mg eq Zr/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f871d996-c143-46fb-8769-bb46fb93590a/documents/IUC5-e3e38451-2f2f-4ecd-a0c5-86d75c9c22dc_574fb42e-96fb-4c18-9a9a-25b55e5e6ae8.html,,,,,, Hafnium tetrachloride,13499-05-3,"On the basis of column 2 of REACH annex VIII, and in accordance with REACH Annex XI, section 2, testing is technically not feasible since the registered substance is not stable and degrades instantaneously. In these conditions, the repeated toxicity is not relevant and the substance needs to be estimated considering the toxicity of its degradation products, that is to say long term toxicity of HCl and HfOCl2 then HfO2. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74561b96-14da-4ee7-a987-8e51774c37d2/documents/IUC5-9a908b38-6561-4a06-9ece-208a0bbf50c6_659af462-b70a-4883-91ce-4269f5de92ba.html,,,,,, Hafnium tetrachloride,13499-05-3,"Based on pH, acid reserve and Corrositex test, HfCl4 is corrosive and tests for acute toxicity are not performed for animal welfare considerations. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74561b96-14da-4ee7-a987-8e51774c37d2/documents/IUC5-7c05a007-8ba9-454d-ba5a-bb02c63f04a5_659af462-b70a-4883-91ce-4269f5de92ba.html,,,,,, "Hematite, chromium green black",68909-79-5,"Sub-acute oral toxicity 28 -day repeated dose toxicity studies were conducted in rats as a limit test to assess the effect of the analogue pigments chromium iron oxide and manganese alumina pink corundum on rats following repeated oral administration. The studies were performed according to OECD test guideline 407 and in compliance with GLP. No signs of toxicity were observed in rats when administered at a dose of 1000 mg/kg bw/day for up to 28 days. Consequently, the no observed adverse effect level (NOAEL) in rats is 1000 mg/kg/day.   Sub-chronic inhalation toxicity 90 -day repeated dose inhalation toxicity studies with the analogue pigments chromium iron oxide and manganese alumina pink corundum are available. The studies were performed according to OECD test guideline 413 and in compliance with GLP. No signs of local or systemic toxicity up to the maximum tolerated concentration were reported in the study records of the source substances. The highest concentrations in both studies caused a more than 2-fold increase of the lung clearance half times, indicating for an overload of particle clearance (hence exceeting the maximum tolerated concentration). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e62d091-b361-41ff-a4fc-8dd0eb78217f/documents/0f5cd9e9-8886-4de7-befc-f5b4e14a7b7a_7920d166-a006-4ceb-be45-afb853794c0b.html,,,,,, "Hematite, chromium green black",68909-79-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e62d091-b361-41ff-a4fc-8dd0eb78217f/documents/0f5cd9e9-8886-4de7-befc-f5b4e14a7b7a_7920d166-a006-4ceb-be45-afb853794c0b.html,Repeated dose toxicity – local effects,inhalation,NOAEC,6 mg/m3,no adverse effect observed,rat "Hematite, chromium green black",68909-79-5," Acute oral lethal dose (LD 50): > 2000 mg/kg bw. Acute toxicity, inhalation: LC50  >5.14 mg/L air. MMAD: 3.455 µm (GSD: 2.87) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e62d091-b361-41ff-a4fc-8dd0eb78217f/documents/IUC5-53697f56-058b-4c41-9898-536ea56569d4_7920d166-a006-4ceb-be45-afb853794c0b.html,,,,,, Heptadecafluorooctanesulphonyl fluoride,307-35-7,"For PFOS, similar toxic effects are produced in subchronic studies in rats and monkeys. These effects are generally characterized as body-weight or body-weight gain decreases, liver-weight orelative liver-weight increases, liver cell hypertrophy, in some cases with vacuolation, and a reduction in serum cholesterol levels. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fdc86f6-5806-4648-a33b-51dc910ca185/documents/IUC5-e09a6f5b-3efd-4bdf-ae1b-43a48d893611_a61df060-da94-4cfd-8a7c-430de0fa8e62.html,,,,,, "Heptadecanol, branched and linear",90388-00-4,"LD50(oral) > 2000 mg/kg bw (BASF, 2009) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67e3b5d2-2c57-41fe-8454-050e1fd98017/documents/IUC5-6fa31540-235e-46d9-91ae-737de527ed54_0e035e94-f679-490c-8bf2-29b4ea16ff83.html,,,,,, "Heptanal, 2-(phenylmethylene)-, (2E)-",78605-96-6," Sub-chronic oral toxicity studies are available for amyl cinnamic aldehyde; both sub-acute and sub-chronic dermal toxicity studies are available for the read-across substance hexyl cinnamic aldehyde. Systemic oral toxicity was evident in the subchronic dietary study for rats treated at 4000 ppm, the effects included enlarged liver and kidneys.  Reduced stomach weights, males, and small intestine weights, females, were evident after six weeks of treatment.  No treatment related microscopic changes were evident. Systemic dermal effects observed following subchronic exposure included mortalities at the higher dose levels (1000 and 500 mg/kg bw/day), reduced bodyweights and increased food consumption trends at 250, 500 and 1000 mg/kg bw/day. Elevated white cell counts in the higher dose levels. Necropsy revealed gastrointestinal mucosal irritation and dermal irritation.  The observation of gastrointestinal effects suggested ingestion via grooming may have contributed more to systemic effects than any material absorbed via the skin (dermal absorption is very low for HCA = 0.183%) .   In the second subchronic investigation the highest dose tested, 25 mg/kg bw/d elicited no notable systemic effects following dermal application. Local dermal effects were limited to instances of skin dryness, cracking and sloughing and local erythema at the site of application. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b24f1f8-82b4-4d61-bb52-8d5260d7f827/documents/IUC5-d5b59ae2-5ebf-4092-b2b8-61a4cf0c5967_49f006e2-7173-43b1-b740-bb8d02011d9e.html,,,,,, "Heptanal, 2-(phenylmethylene)-, (2E)-",78605-96-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b24f1f8-82b4-4d61-bb52-8d5260d7f827/documents/IUC5-d5b59ae2-5ebf-4092-b2b8-61a4cf0c5967_49f006e2-7173-43b1-b740-bb8d02011d9e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "Heptanal, 2-(phenylmethylene)-, (2E)-",78605-96-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b24f1f8-82b4-4d61-bb52-8d5260d7f827/documents/IUC5-d5b59ae2-5ebf-4092-b2b8-61a4cf0c5967_49f006e2-7173-43b1-b740-bb8d02011d9e.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,125 mg/kg bw/day,,rat "Heptanal, 2-(phenylmethylene)-, (2E)-",78605-96-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b24f1f8-82b4-4d61-bb52-8d5260d7f827/documents/IUC5-d5b59ae2-5ebf-4092-b2b8-61a4cf0c5967_49f006e2-7173-43b1-b740-bb8d02011d9e.html,Repeated dose toxicity – local effects,dermal,NOAEL,25 mg/cm2,adverse effect observed,rat "Heptanal, 2-(phenylmethylene)-, (2E)-",78605-96-6, Acute oral and dermal toxicity studies are available for amyl cinnamic aldehyde. An acute inhalaton toxicity study is available for the read-across substance hexyl cinnamic aldehyde. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b24f1f8-82b4-4d61-bb52-8d5260d7f827/documents/IUC5-03e0124f-27b1-43e5-9142-7f037bc44c42_49f006e2-7173-43b1-b740-bb8d02011d9e.html,,,,,, "Heptanal, 2-(phenylmethylene)-, (2E)-",78605-96-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b24f1f8-82b4-4d61-bb52-8d5260d7f827/documents/IUC5-03e0124f-27b1-43e5-9142-7f037bc44c42_49f006e2-7173-43b1-b740-bb8d02011d9e.html,,oral,LD50,"3,730 mg/kg bw",no adverse effect observed, "Heptanal, 2-(phenylmethylene)-, (2E)-",78605-96-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b24f1f8-82b4-4d61-bb52-8d5260d7f827/documents/IUC5-03e0124f-27b1-43e5-9142-7f037bc44c42_49f006e2-7173-43b1-b740-bb8d02011d9e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Heptanal, 2-(phenylmethylene)-, (2E)-",78605-96-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b24f1f8-82b4-4d61-bb52-8d5260d7f827/documents/IUC5-03e0124f-27b1-43e5-9142-7f037bc44c42_49f006e2-7173-43b1-b740-bb8d02011d9e.html,,inhalation,LC50,"2,120 mg/m3",no adverse effect observed, "Heptanal, oligomeric reaction products with aniline",9003-50-3, 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test of Hepteen Base® in rats by oral gavage including a preliminary dose range finding study. 28- NOAEL: Females: 50 mg/kg/day Males: 150 mg/kg/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8dee6044-22e6-42be-bddb-64913354182c/documents/ed6231c0-cc62-451d-b71e-e27596f570fb_2f7c47b0-73e6-4dfa-aca0-709f621bad4f.html,,,,,, "Heptanal, oligomeric reaction products with aniline",9003-50-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8dee6044-22e6-42be-bddb-64913354182c/documents/ed6231c0-cc62-451d-b71e-e27596f570fb_2f7c47b0-73e6-4dfa-aca0-709f621bad4f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Heptanal, oligomeric reaction products with aniline",9003-50-3," Acute Toxicity via Dermal Route Key value determined in a GLP accredited laboratory study using the standard acute method, in accordance with OECD Guideline 402, EU Method B.3, JMAFF, 12 Nousan, Notification No 8147 and EPA OPPTS 870.1200. The dermal LD50 value of Hepteen Base ® in Wistar rats was established to exceed 2000 mg/kg body weight. Acute Toxicity via Oral Route Key value determined in a GLP accredited laboratory study using the standard acute method, in accordance with OECD Guideline No. 423 (2001), EU method B1, US EPA OPPTS 870.1100 (2002) and JMAFF Guidelines (2000). The oral LD50 of Hepteen Base ® in Wistar rats was established to exceed 2000 mg/kg body weight. Acute Toxicity via Inhalation Route Endpoint waived. Substance supplied liquid form and does not have the propensity to produce airborne dust. In addition physicochemical data on the test substance showed that it had a low vapour pressure and no boiling point, which indicates the liquid is not volatile consequently  route of exposure to humans or the environment via the inhalation route would not be possible REACH REGULATION Annex VII COLUMN 2: SPECIFIC RULES FOR ADAPTATION FROM COLUMN 1 - 7.14.  ""The study does not need to be conducted if the substance is marketed or used in a non solid or granular form."" Test data has been provided for dermal and oral Acute Toxicity endpoints see sections 7.2.1 and 7.2.3 for more details. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dee6044-22e6-42be-bddb-64913354182c/documents/9dfce211-3d60-4553-b584-ff7311ece680_2f7c47b0-73e6-4dfa-aca0-709f621bad4f.html,,,,,, "Heptanal, oligomeric reaction products with aniline",9003-50-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dee6044-22e6-42be-bddb-64913354182c/documents/9dfce211-3d60-4553-b584-ff7311ece680_2f7c47b0-73e6-4dfa-aca0-709f621bad4f.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "Heptanal, oligomeric reaction products with aniline",9003-50-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dee6044-22e6-42be-bddb-64913354182c/documents/9dfce211-3d60-4553-b584-ff7311ece680_2f7c47b0-73e6-4dfa-aca0-709f621bad4f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Heptanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol pentanoate",67762-64-5,"A 28 day oral repeated dose toxicity study was conducted in rats with read-across substance, fatty acids, C5-10, esters with pentaerythritol. Repeated dietary administration of the test material to rats, up to and including a dose level of 1450 mg/kg bw/day for male rats and 1613 mg/kg bw/d for female rats, did not produce any evidence of overt toxicity. In a prenatal development study in rats, read-across substance, decanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol octanoate, was administered by the dermal route. The NOAEL for local maternal toxicity was determined to be 200 mg/kg bodyweight (5.7 mg/cm2). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/631e4c02-7107-41b1-89bc-b3db15e9757a/documents/IUC5-670109a1-3d59-43de-ab69-ad08d38bb9f0_6b162df4-017d-4de1-bb03-7143d4a74a3a.html,,,,,, "Heptanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol pentanoate",67762-64-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/631e4c02-7107-41b1-89bc-b3db15e9757a/documents/IUC5-670109a1-3d59-43de-ab69-ad08d38bb9f0_6b162df4-017d-4de1-bb03-7143d4a74a3a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,450 mg/kg bw/day",,rat "Heptanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol pentanoate",67762-64-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/631e4c02-7107-41b1-89bc-b3db15e9757a/documents/IUC5-670109a1-3d59-43de-ab69-ad08d38bb9f0_6b162df4-017d-4de1-bb03-7143d4a74a3a.html,Repeated dose toxicity – local effects,dermal,NOAEL,5.7 mg/cm2,no adverse effect observed,rat "Heptanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol pentanoate",67762-64-5,"In conclusion, by read-across, heptanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol pentanoate is considered to be of low acute toxicity by the oral and the dermal routes. An acute inhalation toxicity study was not conducted because exposure to humans via the inhalatory route is unlikely to occur. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/631e4c02-7107-41b1-89bc-b3db15e9757a/documents/IUC5-1240d4b7-0807-47d8-b610-b648d2f21a10_6b162df4-017d-4de1-bb03-7143d4a74a3a.html,,,,,, "Heptanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol pentanoate",67762-64-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/631e4c02-7107-41b1-89bc-b3db15e9757a/documents/IUC5-1240d4b7-0807-47d8-b610-b648d2f21a10_6b162df4-017d-4de1-bb03-7143d4a74a3a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Heptanoic acid, ester with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol pentanoate",67762-64-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/631e4c02-7107-41b1-89bc-b3db15e9757a/documents/IUC5-1240d4b7-0807-47d8-b610-b648d2f21a10_6b162df4-017d-4de1-bb03-7143d4a74a3a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Heptanoic anhydride,626-27-7,LD50 oral (rat): > 2000 mg/kg bwLD50 dermal (rat): > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fc428ec-89f5-4cb5-a806-cae113308467/documents/IUC5-f5386303-1041-48b8-bddf-2e7845768a01_94a4e562-cc6a-418e-93f0-13af833c4b7a.html,,,,,, Heptanoic anhydride,626-27-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fc428ec-89f5-4cb5-a806-cae113308467/documents/IUC5-f5386303-1041-48b8-bddf-2e7845768a01_94a4e562-cc6a-418e-93f0-13af833c4b7a.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Heptanoic anhydride,626-27-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fc428ec-89f5-4cb5-a806-cae113308467/documents/IUC5-f5386303-1041-48b8-bddf-2e7845768a01_94a4e562-cc6a-418e-93f0-13af833c4b7a.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Heptasodium bis[4-hydroxy-5-[(2-hydroxy-1-naphthyl)azo]-3-[(2-hydroxy-3-nitro-5-sulphophenyl)azo]naphthalene-2,7-disulphonato(5-)]cobaltate(7-)",74196-18-2," LD50 (oral, rat) > 10000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1671aa7b-ac23-43b1-acc7-9410590d7350/documents/16911086-c4e0-4cc8-8bc9-8a23e4a165ee_8eb3e814-89e8-4392-bcb7-b61052b8d0e8.html,,,,,, "Heptasodium bis[4-hydroxy-5-[(2-hydroxy-1-naphthyl)azo]-3-[(2-hydroxy-3-nitro-5-sulphophenyl)azo]naphthalene-2,7-disulphonato(5-)]cobaltate(7-)",74196-18-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1671aa7b-ac23-43b1-acc7-9410590d7350/documents/16911086-c4e0-4cc8-8bc9-8a23e4a165ee_8eb3e814-89e8-4392-bcb7-b61052b8d0e8.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Heptylamine,111-68-2," Acute oral toxicity The Acute oral toxicity of mono-n-heptylamine was evaluated in male and female rats according to OECD N°401 guideline (Acute Toxic Standard Method) in compliance with principles of Good Laboratory Practices (Guillot, 1990). Animals were treated and then observed for 14 days for mortality, clinical signs and effect on body weight. Under the experimental conditions, the LD50 of the test article administered as supplied, is equal to 74 mg/kg (49 - 110 mg/kg) according to BLISS'method and to 70 mg/kg (48 - 102 mg/kg) according to LITCHFIELD & WILCOXON's method. Acute dermal toxicity The potential acute toxicity of the test substance n-HEPTYLAMINE was evaluated in rats according to the recommendations of the O.E.C.D. Guideline No. 402 (O.E.C.D., 24th February 1987) administered by dermal route and the Principles of Good Laboratory Practice (O.E.C.D., 12th May 1981) (Clouzeau, 1992). The test substance was applied in its original form directly to the skin of 10 Sprague-Dawley rats (5 males and 5 females) at a dose level of 2000 mg/kg, taking into consideration that the specific gravity (SG) of the test substance was 0.773. After 24 hours under a semi-occlusive dressing, no residual test substance was observed at removal of the dressing. The animals were checked for clinical signs, mortality and body weight gain for a period of 14 days after the single application of the test substance. A necropsy was performed on each animal sacrificed at the end of the study. No clinical signs were observed after application of the test substance. Between days 2 and 15, signs of necrosis of the skin without tissular lesions on the whole depth of the skin were observed on the area receiving the test substance. Between days 2 and 5, the body weight gain of the females slowed down and that of the males was reduced by 5 g. The body weight gain of all animals returned to normal thereafter. No deaths occurred at the dose level of 2000 mg/kg. Under our experimental conditions, the LD0 of the test substance n-HEPTYLAMINE when administered by dermal route in rats was higher than 2000 ng/kg. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29e730e8-7da1-4614-bf3f-651a987d82d7/documents/IUC5-693ffe4b-00a0-4cfb-b94f-926f5ee8d48b_6e9b071f-459d-41d3-a180-a4ff5a11ba86.html,,,,,, Heptylamine,111-68-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29e730e8-7da1-4614-bf3f-651a987d82d7/documents/IUC5-693ffe4b-00a0-4cfb-b94f-926f5ee8d48b_6e9b071f-459d-41d3-a180-a4ff5a11ba86.html,,oral,LD50,74 mg/kg bw,adverse effect observed, Heptylamine,111-68-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29e730e8-7da1-4614-bf3f-651a987d82d7/documents/IUC5-693ffe4b-00a0-4cfb-b94f-926f5ee8d48b_6e9b071f-459d-41d3-a180-a4ff5a11ba86.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Hex-3-yne-2,5-diol",3031-66-1,"The subacute toxicity oral of 3-Hexyne-2,5-diol was assessed in a study performed according to OECD Guideline 422 in rats. Based on these observations the No Observed (Adverse) Effect Levels (NO(A)EL) were determined to be 5 mg/kg bw/day for male and female rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c85086f1-9651-41b5-ac6c-195e50129de5/documents/IUC5-8cf84eca-8ad8-430e-bbb4-0aa3a547e6a1_cda8f939-bae9-43b8-8e35-4f62745bb159.html,,,,,, "Hex-3-yne-2,5-diol",3031-66-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c85086f1-9651-41b5-ac6c-195e50129de5/documents/IUC5-8cf84eca-8ad8-430e-bbb4-0aa3a547e6a1_cda8f939-bae9-43b8-8e35-4f62745bb159.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat "Hex-3-yne-2,5-diol",3031-66-1,LD50 oral rat 140 mg/kg bw. Temperature dependent increase of mortality after 8 hours inhalation exposure. LD50 dermal >2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c85086f1-9651-41b5-ac6c-195e50129de5/documents/IUC5-9e6797fa-8ba1-486a-a58c-6f12c6c7401c_cda8f939-bae9-43b8-8e35-4f62745bb159.html,,,,,, "Hex-3-yne-2,5-diol",3031-66-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c85086f1-9651-41b5-ac6c-195e50129de5/documents/IUC5-9e6797fa-8ba1-486a-a58c-6f12c6c7401c_cda8f939-bae9-43b8-8e35-4f62745bb159.html,,oral,LD50,140 mg/kg bw,adverse effect observed, "Hex-3-yne-2,5-diol",3031-66-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c85086f1-9651-41b5-ac6c-195e50129de5/documents/IUC5-9e6797fa-8ba1-486a-a58c-6f12c6c7401c_cda8f939-bae9-43b8-8e35-4f62745bb159.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Hexa-1,5-diene",592-42-7," A GLP OECD 425 study is available in the rat. The oral LD50 value of 1,5-hexadiene in Wistar rats was established to exceed 2000 mg/kg body weight. No data are required for dermal/inhalation toxicity at this tonnage band. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8dcf0f3-caad-4dfb-aac5-85f9202614bd/documents/5c4d0b06-4beb-4569-9dbe-9a2938ec10f3_43f84c7f-b429-4a10-a341-f341343cd1fa.html,,,,,, "Hexa-1,5-diene",592-42-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8dcf0f3-caad-4dfb-aac5-85f9202614bd/documents/5c4d0b06-4beb-4569-9dbe-9a2938ec10f3_43f84c7f-b429-4a10-a341-f341343cd1fa.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Hexaammonium heptamolybdate,12027-67-7,"NOAEL for systemic toxicity, oral, from a sub-chronic study with sodium molybdate dihydrate in rats (Hoffman, 2011): 17 mg Mo/kg bw/day. Unbounded NOAEC for systemic toxicity, inhalation, from a sub-chronic study with molybdenum trioxide in rats and mice (NTP, 1997): 66.7 mg Mo/m³. Important: both values expressed based on element Mo (for read-across purposes), not on the respective test substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c71b9d5-03b5-435c-b9b7-570673d6a260/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_9a5a8b34-1083-4c49-b995-f051b98ebf75.html,,,,,, Hexaammonium heptamolybdate,12027-67-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c71b9d5-03b5-435c-b9b7-570673d6a260/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_9a5a8b34-1083-4c49-b995-f051b98ebf75.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat Hexaammonium heptamolybdate,12027-67-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c71b9d5-03b5-435c-b9b7-570673d6a260/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_9a5a8b34-1083-4c49-b995-f051b98ebf75.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,66.7 mg/m3,,other:rats and mice Hexaammonium heptamolybdate,12027-67-7," To avoid unnecessary (animal) testing, a comprehensive grouping and read-across concept has been developed amongst several molybdenum containing substances. Acute oral, inhalation and dermal toxicity studies are available for several but not all substances in the category. The following LD50s are therefore either based on test data for the substance in this dossier, or based on read-across within the category: For ammonium heptamolybdate: LD50 oral: > 2000 mg/kg  (estimated, based on category read-across) LD50 inhalation, 4h: > 5 g/m³ (estimated, based on category read-across) LD50 dermal: > 2000 mg/kg (estimated, based on category read-across) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c71b9d5-03b5-435c-b9b7-570673d6a260/documents/IUC5-48b70223-ec2c-4098-b42a-3a1cdc92dbf5_9a5a8b34-1083-4c49-b995-f051b98ebf75.html,,,,,, Hexaammonium wolframate,12028-48-7," Repeated Dose Toxicity - Oral Route: No oral repeated dose toxicity data of sufficient quality were available specifically on ammonium metatungstate (target substance). However, oral repeated dose toxicity data are available on sodium tungstate (source substance), which are used for read-across. Due to similar water solubility and toxicity for the target substance compared to the source substance, the resulting read-across from the source substance to the target substance is appropriate for this endpoint. In addition, read-across is appropriate because the classification and labelling is similar for the source substance and target substance, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, conservative for the target substance. For more details, refer to the read-across category approach description in the Category section of this IUCLID submission or Annex 3 of the CSR. The read across study on sodium tungstate was sponsored conducted the United States Army Center for Health Promotion and Preventive Medicine and published by McCain et al (2015). The 90-day oral toxicity study was conducted in rats according to the procedure described in the Environmental Protection Agency (EPA) Health Effects Testing Guidelines (40 CFR, Part 798.2650) in compliance with Good Laboratory Practice. Briefly, this study of the subchronic toxicity of sodium tungstate dihydrate aqueous solution in male and female Sprague-Dawley rats was evaluated by daily oral gavage of 0, 10, 75, 125, or 200 mg/kg bw/d for 90 days. Measured parameters included food consumption, body weight measurements, hematology, clinical chemistry, and histopathological changes. There was a significant decrease in food consumption and body weight gain in males at 200 mg/kg bw/d from days 77 to 90; however, there was no effect in food consumption and body weights in females. There were no changes in the hematological and clinical parameters studied. Histopathological changes were seen in kidney of male and female and epididymis of male rats. The histopathological changes observed in the kidneys of male and female rats dosed at 125 or 200 mg/k/d consisting of mild to severe cortical tubule basophilia in 2 high-dose groups. Histological changes in epididymides included intraluminal hypospermia with cell debris in the 200 mg/kg bw/day dosed male rats. Histopathological changes were observed in the glandular stomach including inflammation and metaplasia in the high-dose groups (125 or 200 mg/kg bw/day) of both sexes of rats. Based on histopathology effects seen in the kidneys, the lowest observable adverse effect level was 125 mg/kg bw/d and the no observable adverse effect level was 75 mg/kg bw/d in both sexes of rats for oral subchronic toxicity. The USEPA’s Benchmark Dose Software (BMDS, Version 1.4.1) was used to model the data to derive a BMDL10. The lowest (most precautionary) BMDL10 from the renal toxicity endpoint in the 90-day oral toxicity study was 102 mg/kg bw/d. In addition to McCain et al. (2015) rat oral 90-day repeated dose study, the US National Toxicology Program (NTP) has conducted two additional 90-day drinking water studies, one in Sprague-Dawley rats and a second one in B6C3F1 mice (10/sex/species/dose). The study design included doses of0, 125, 250, 500, 1000, or 2000 mg/L. The in-life study phase has been completed but no study report has yet been issued. Currently, available in the US NTP website are graphs and Tables are preliminary results, but no full report has been issued. Furthermore, at the 2012 Annual Meeting of the Society of Toxicology, a Scientific Poster was presented detailing preliminary results of the NTP study. Preliminary results confirm the results of the McCain gavage study, showing the kidney as the major target organ for tungstate (especially at high drinking water doses of 1,000 and 2,000 mg/L). The US NTP’s final reports of sodium tungstate would be available by 2022. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0b73bb3-70c5-4e7f-b8be-793cb8edca87/documents/9ed338f3-273c-4e5f-b8a9-36691db0e499_d33f1de2-51e2-4ee5-99d1-1da91c162baa.html,,,,,, Hexaammonium wolframate,12028-48-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0b73bb3-70c5-4e7f-b8be-793cb8edca87/documents/9ed338f3-273c-4e5f-b8a9-36691db0e499_d33f1de2-51e2-4ee5-99d1-1da91c162baa.html,Sub-chronic toxicity – systemic effects,oral,BMDL10,102 mg/kg bw/day,,rat Hexaammonium wolframate,12028-48-7," An acute oral toxicity of sufficient quality and conducted according to OECD 423 reported an LD50 of 10002000 mg/kg bw for all of the read-across substances. Acute inhalation toxicity studies performed according to OECD 403 are available for ammonium paratungstate and sodium tungstate, which report a 4-h LC50 >5.35 mg APT/L air (ca. 3.14 mg W/L air) for ammonium metatungstate and a 4-h LC50 >5.01 mg sodium tungstate/L air (ca. 2.94 mg W/L air) for sodium tungstate. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0b73bb3-70c5-4e7f-b8be-793cb8edca87/documents/IUC5-54ba216a-163f-46f2-88fb-a7562e2cf213_d33f1de2-51e2-4ee5-99d1-1da91c162baa.html,,,,,, Hexaammonium wolframate,12028-48-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0b73bb3-70c5-4e7f-b8be-793cb8edca87/documents/IUC5-54ba216a-163f-46f2-88fb-a7562e2cf213_d33f1de2-51e2-4ee5-99d1-1da91c162baa.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, Hexaammonium wolframate,12028-48-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0b73bb3-70c5-4e7f-b8be-793cb8edca87/documents/IUC5-54ba216a-163f-46f2-88fb-a7562e2cf213_d33f1de2-51e2-4ee5-99d1-1da91c162baa.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, Hexaammonium wolframate,12028-48-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0b73bb3-70c5-4e7f-b8be-793cb8edca87/documents/IUC5-54ba216a-163f-46f2-88fb-a7562e2cf213_d33f1de2-51e2-4ee5-99d1-1da91c162baa.html,,inhalation,LC50,"5,350 mg/m3",no adverse effect observed, Hexaboron dizinc undecaoxide,12767-90-7,"1) 28-day sub-acute study on zinc borate (hydrate) was carried out in rats (Wragg et al 1996);2) 90-day repeated dose study of zinc borate heptahydrate, rats, oral gavage, NOAEL 100 mg/kg bw (males), 375 mg/kg bw (females), (Kirkpatrick, 2014);3) Allen et al., 1996: BMD of 59 mg of Boric acid/kg bw (equivalent to 10.3 mg Boron/kg bw) was calculated;4) repeated dose inhalation toxicity of zinc oxide (Placke, 1990);5) subacute repeated dose inhalation toxicity of aerosolized zinc borate heptahydrate in rats, a minimum of ten exposures (Randazzo, 2014) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc2084a8-4029-4206-b6fa-0215c624ef38/documents/c40323a0-458d-47fe-8a39-5eeca1dbbcdd_11f9143d-b22e-4c73-a39e-9d69e2277ae7.html,,,,,, Hexaboron dizinc undecaoxide,12767-90-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc2084a8-4029-4206-b6fa-0215c624ef38/documents/c40323a0-458d-47fe-8a39-5eeca1dbbcdd_11f9143d-b22e-4c73-a39e-9d69e2277ae7.html,Short-term repeated dose toxicity – systemic effects,oral,BMDL05,10.3 mg/kg bw/day,,rat Hexaboron dizinc undecaoxide,12767-90-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc2084a8-4029-4206-b6fa-0215c624ef38/documents/c40323a0-458d-47fe-8a39-5eeca1dbbcdd_11f9143d-b22e-4c73-a39e-9d69e2277ae7.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,106 mg/m3,,rat Hexaboron dizinc undecaoxide,12767-90-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc2084a8-4029-4206-b6fa-0215c624ef38/documents/c40323a0-458d-47fe-8a39-5eeca1dbbcdd_11f9143d-b22e-4c73-a39e-9d69e2277ae7.html,Repeated dose toxicity – local effects,inhalation,NOAEC,3 mg/m3,adverse effect observed,rat Hexaboron dizinc undecaoxide,12767-90-7,"Acute oral and dermal studies have been performed with zinc borate anhydrous and the heptahydrate. In addition, acute oral, dermal and inhalation studies on an analogue substance have been performed. Experimental data showed low acute toxicity to zinc borate. The mean of the male and female values were obtained from the key study (oral route; Kreuzmann, 1990). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc2084a8-4029-4206-b6fa-0215c624ef38/documents/7f717bd7-f756-444b-81f7-3c6164a1c1c6_11f9143d-b22e-4c73-a39e-9d69e2277ae7.html,,,,,, Hexaboron dizinc undecaoxide,12767-90-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc2084a8-4029-4206-b6fa-0215c624ef38/documents/7f717bd7-f756-444b-81f7-3c6164a1c1c6_11f9143d-b22e-4c73-a39e-9d69e2277ae7.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Hexaboron dizinc undecaoxide,12767-90-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc2084a8-4029-4206-b6fa-0215c624ef38/documents/7f717bd7-f756-444b-81f7-3c6164a1c1c6_11f9143d-b22e-4c73-a39e-9d69e2277ae7.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Hexaboron dizinc undecaoxide,12767-90-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc2084a8-4029-4206-b6fa-0215c624ef38/documents/7f717bd7-f756-444b-81f7-3c6164a1c1c6_11f9143d-b22e-4c73-a39e-9d69e2277ae7.html,,inhalation,LC50,4.95 mg/m3,no adverse effect observed, Hexabromocyclododecane,25637-99-4,"The following information is presented for this endpoint:Chengelis C. P. (1996). A 28 Day Repeated-Dose Oral Toxicity Study of HBCD in Rats. Report no.: WIL 186004. Report date: 1997-02-13. as amended by,Chengelis C. P. (1998). Addendum to the final report A 28-day repeated dose oral toxicity study of HBCD in rats. Report date: 1998-05-28.Chengelis C.P. (2001). An Oral(Gavage) 90 Day Toxicity Study of HBCD in Rats. Report no.: WIL-186012. Report date: 2001-12-14.van der Ven, L. T. M., Verhoef, A., van de Kuil, T., Slob, W., Leonards, P. E. G., Visser, T. J., Hamers, T., Herlin, M., Håkansson, H., Olausson, H., Piersma, A. H. and Vos, J. G. (2006). A 28-day oral dose toxicity study enhanced to detect endocrine effects of Hexabromocyclododecane in Wistar rats. Toxicological Sciences (2006) Vol. 94(2), pp. 281-292.Chengelis (2001) and Chengelis (1996) as amended by Chengelis (1998) were both awarded reliability scores of 1 according to the criteria of Klimisch et al. (1997) based upon the recognised study guidelines used within the methodologies, the GLP conditions which were in effect throughout the study period and depth of reporting of methodologies, results and substance identification information. Chengelis (2001) was selected as the key study for this endpoint as it is the only sub-chronic study available for the registered subtance, it is also the most recent and reliable study available.Van der Ven et al. (2006) was also conducted according to recognised testing guidelines however information regarding GLP conditions was not reported and so reliability was reduced to a score of 2 in line with criteria set out by Klimisch et al. (1997). ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/11e22a93-7a33-4d28-81c9-b5bda1a32a57/documents/IUC5-d668aa9f-1273-4cfc-be99-48350fe0fb4d_b64d1117-2c41-4a96-bc2f-d331ead1af85.html,,,,,, Hexabromocyclododecane,25637-99-4,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/11e22a93-7a33-4d28-81c9-b5bda1a32a57/documents/IUC5-d668aa9f-1273-4cfc-be99-48350fe0fb4d_b64d1117-2c41-4a96-bc2f-d331ead1af85.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Hexabromocyclododecane,25637-99-4,"The key study for each route of exposure was chosen for this endpoint as follows:Oral exposure route:Dean, W. P. and Leong, B. K. J. (1977a). Acute toxicity study in Rabbits and Rats.Report no.: 163-499. Report date: 1977-12-07.Dermal exposure route:Dean, W. P. and Leong, B. K. J. (1977a). Acute toxicity study in Rabbits and Rats. Report no.: 163-499.Report date: 1977-12-07.Inhalation route:Dean, W. P. and Leong, B. K. J. (1977a). Acute toxicity study in Rabbits and Rats. Report no.: 163-499. Report date: 1977-12-07.Dean and Long (1977a) was chosen as the key study for each route of exposure based upon the result of the reliability assessment, age of the study and depth of reporting. This study was awarded a reliability score of 2 according to the Klimisch et al. (1997) criteria. Although other sources of available information were also awarded a reliability score of 2 according to the same criteria, it was considered that this study provided more complete reporting of test methodology and results and so was chosen as the key study. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11e22a93-7a33-4d28-81c9-b5bda1a32a57/documents/IUC5-f0157df7-93bb-4dad-8a56-9cdb814f17a6_b64d1117-2c41-4a96-bc2f-d331ead1af85.html,,,,,, Hexacalcium hexaoxotris[sulphato(2-)]dialuminate(12-),12004-14-7,"Data and assessment from CaSO4 according to justification for read across (see separate document in iuclid chapter 13). Repeated dose oral: Currently, seven different animal studies are available that have evaluated the repeated dose toxicity of (calcium) sulfate. None of the studies describes any severe toxicological effects after oral administration of (calcium) sulfate.Repeated dose inhalation: Currently, four different animal studies are available that have evaluated the repeated dose inhalation toxicity of (calcium) sulfate. Besides the animal studies, several health surveillance data, mainly from gypsum miners are also available. Repeated dose dermal: No studies on dermal toxicity of calcium sulphate are available ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c8c6209-b801-486d-8cae-bde959d33803/documents/IUC5-420f151d-ac79-44b2-a073-8a76fef88762_d578be66-c07e-4585-9a13-d031691445e8.html,,,,,, Hexacalcium hexaoxotris[sulphato(2-)]dialuminate(12-),12004-14-7,"For Ettringite:No acute oral or dermal toxicity was observed up to the highest tested doses. LD50 (oral)/ LD50 (dermal): > 2000 mg/kg bw.Further data and assessment from CaSO4 according to justification for read across (see separate document in iuclid chapter 13). LD50 (dihydrate, mouse, oral) = 4704 mg/kg bwLD50 (hemihydrate, mouse, oral) = 5824 mg/kg bwLD50 (dihydrate, rat, oral) = 9934 mg/kg bwLD50 (hemihydrate, rat, oral) = 9934 mg/kg bwNOEC (Inhalation) = 3.26 mg/L calcium sulphate dihydrateIn the registration dossier of CaSO4 is stated:Calcium sulfate is not considered to be harmful by the oral or inhalation route. The dermal toxicity of calcium sulfate is not considered to be relevant. Calcium sulfate is an inorganic ionic solid and is not expected to penetrate the skin. Furthermore, calcium sulfate is commonly used in plaster of Paris, and is not known to have been associated with any toxic effects. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c8c6209-b801-486d-8cae-bde959d33803/documents/IUC5-5678e9ff-1b87-472d-b53b-1143678312a8_d578be66-c07e-4585-9a13-d031691445e8.html,,,,,, Hexachloroacetone,116-16-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a7c4f17-1907-4a2d-a574-7c6803bf5b91/documents/IUC5-c39d3751-d90c-491c-9c17-3b7f0714248c_9d586a8d-d7ac-41f5-b8d9-617368f05eae.html,,oral,LD50,"1,550 mg/kg bw",adverse effect observed, Hexachloroacetone,116-16-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a7c4f17-1907-4a2d-a574-7c6803bf5b91/documents/IUC5-c39d3751-d90c-491c-9c17-3b7f0714248c_9d586a8d-d7ac-41f5-b8d9-617368f05eae.html,,dermal,LD50,"2,980 mg/kg bw",no adverse effect observed, Hexachloroacetone,116-16-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a7c4f17-1907-4a2d-a574-7c6803bf5b91/documents/IUC5-c39d3751-d90c-491c-9c17-3b7f0714248c_9d586a8d-d7ac-41f5-b8d9-617368f05eae.html,,inhalation,LC50,"5,900 mg/m3",adverse effect observed, Hexachlorocyclopentadiene,77-47-4," The repeated dose toxicity of Hexachlorocyclopentadiene by the oral route was evaluated using a method similar to the OECD Test Guideline 408 (non-GLP). Rats received doses of 0, 10, 19, 38, 75 or 150 of Hexachlorocyclopentadiene by gavage once a day, 5 days per week, for 13 weeks. This protocol deviated from the current version of the OECD Test Guideline 408 but was designed to mimic the exposure of workers and is therefore considered as acceptable. Six male rats receiving 150 mg/kg bw/day and one female rats receiving 75 mg/kg bw/day died as a result of the treatment. Other deaths occurred that were attributed to improper gavage technique. Treatment related clinical signs were observed in animals treated at 150 mg/kg bw/day. A significant reduction of the bodyweight was observed in male rats receiving 38 mg/kg bw/day or above and in female rats receiving 75 mg/kg bw/day or above. Significant changes in the relative weight of several organs were observed in relation to the reduction of the bodyweight. In male rats receiving 75 mg/kg bw/day and above and female rats receiving 38 mg/kg bw/day and above, effects in stomach including mass and black areas were observed and considered treatment related. Animals exposed to 38 mg/kg bw/day and above exhibited acute kidney tubular necrosis. In male rats receiving 38 mg/kg bw/day or above and female rats receiving 19 mg/kg bw/day, significant proliferation and inflammatory changes of the epithelia in the stomach were observed. This subchronic toxicity study by the oral route allowed to determine a NOAEL(systemic) of 10 mg/kg bw/day for both male and female rats, a NOAEL(local) of 10 mg/kg bw/day for female rats, and a NOAEL(local) of 19 mg/kg bw/day for male rats.   Several studies were performed investigating the effects of Hexachlorocyclopentadiene following a repeated exposure by inhalation. The subchronic toxicity study performed by the US NTP (1994) on rats was considered as the key study as it was performed on a standard species in compliance with the GLP. Chronic toxicity studies performed by inhalation were available, but they were considered as less reliable for the purpose of the assessment of the repeated-dose toxicity of Hexachlorocyclopentadiene as their purpose was to identify carcinogenic effects and several relevant examinations were omitted. The US NTP (1994) used a method similar to the OECD Test Guideline 413 (GLP). Rats were exposed at concentrations of 0, 0.04, 0.15, 0.4, 1 or 2 ppm of Hexachlorocyclopentadiene in air (equivalent to 0, 0.45, 1.67, 4.46, 11.14 and 22.28 mg/m3) for 6 hours per day, 5 days per week, for 13 weeks. All rats exposed to 1 or 2 ppm of the test substance died in the first 4 weeks of exposure and treatment related clinical signs considered as adverse effects were observed before their deaths, including respiratory distress, extensive coagulation necrosis of the respiratory epithelium, and acute and subacute inflammation. All rats exposed to lower concentrations survived. Animals exposed to 0.4 ppm showed listlessness and suppurative inflammation of the nose or lung (especially in male rats). Final mean body weight and mean body weight gain of male rats exposed to 0.4 ppm were significantly lower than those of the control animals. Lung weights of male rats exposed to 0.4 ppm of test substance were significantly greater than those of the controls. Other differences in organ weights were likely related to the lower body weights observed in exposed rats. This subchronic toxicity study by inhalation allowed to determine a NOAEC of 0.15 ppm (equivalent to 1.67 mg/m3) for both local and systemic effects based on mortality, body weight, and inflammation of the upper and lower respiratory tract.   The repeated dose toxicity of Hexachlorocyclopentadiene by the dermal route was evaluated using a method similar to the OECD Test Guideline 410 (non-GLP). Rabbits received applications of 0.1 or 5 mg/kg bw of Hexachlorocyclopentadiene once a day, 5 days per week, for 4 weeks. No mortality was observed as a result of this study. No systemic effects including significant variation of the body weight of treated animals were observed. The test substance was severely irritating to the skin upon repeated dermal applications at the test concentrations. These findings were confirmed during the gross pathology and histopathology examination that identified various alterations of the skin. This short-term toxicity study by the dermal route performed on the registered substance allowed to determine a NOAEL(systemic) of 5 mg/kg bw/day and a LOAEL(local) of 1 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7c83fa2-327a-433b-b4b9-c36222ba613e/documents/ffcf2e24-6cf1-4e23-bc2f-76607ac0417e_d6e73ce0-4431-41d2-a162-628dd2b493cf.html,,,,,, Hexachlorocyclopentadiene,77-47-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7c83fa2-327a-433b-b4b9-c36222ba613e/documents/ffcf2e24-6cf1-4e23-bc2f-76607ac0417e_d6e73ce0-4431-41d2-a162-628dd2b493cf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Hexachlorocyclopentadiene,77-47-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7c83fa2-327a-433b-b4b9-c36222ba613e/documents/ffcf2e24-6cf1-4e23-bc2f-76607ac0417e_d6e73ce0-4431-41d2-a162-628dd2b493cf.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,1.67 mg/m3,,rat Hexachlorocyclopentadiene,77-47-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7c83fa2-327a-433b-b4b9-c36222ba613e/documents/ffcf2e24-6cf1-4e23-bc2f-76607ac0417e_d6e73ce0-4431-41d2-a162-628dd2b493cf.html,Repeated dose toxicity – local effects,dermal,LOAEL,4.33 ,adverse effect observed, Hexachlorocyclopentadiene,77-47-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7c83fa2-327a-433b-b4b9-c36222ba613e/documents/ffcf2e24-6cf1-4e23-bc2f-76607ac0417e_d6e73ce0-4431-41d2-a162-628dd2b493cf.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1.67 mg/m3,adverse effect observed,rat Hexachlorocyclopentadiene,77-47-4,"A Harmonised Classification as Acute Tox 4, H302 (oral route), Acute Tox 2, H330 (inhalation) and Acute Tox. 3; H311 (dermal route) is currently attributed to Hexachlorocyclopentadiene for acute toxicity. This Harmonised Classification was translated from Directive 67/548/EEC and should therefore be considered as a minimum classification unless there is evidence showing that the substance should be classified more severely according to Annex VI Section 1.2 of Regulation (EC) N° 1272/2008.   The acute toxicity via oral route of Hexachlorocyclopentadiene was determined by Huntingdon Research Centre (1986) using a procedure similar to the OECD Testing Guideline 401. This study was selected as a key study due to the lack of information on necropsy or clinical information in the other studies available for this endpoint. Mortality was observed following ingestion of the substance, along with a reduction of the bodyweight gain and clinical signs of adverse effects in surviving animals from the highest dose groups. These effects were fully reversible by the end of the observation period (14 days). The LD50 for male and female rats was found to be 1,400 mg/kg bw. The substance meets the criteria for classification as Acute Tox 4, H302 according to Regulation (EC) N° 1272/2008. It is consistent with the current Harmonised Classification of the substance.   The acute toxicity via inhalation of Hexachlorocyclopentadiene was determined by Rand et al. (1982) using a procedure equivalent to the OECD Testing Guideline 403. This study was selected as a key study; the other available studies for this endpoint showed to have significant methodological deficiencies and were used as supporting studies. In the Rand et al. (1982) study mortality was observed with the majority of the deaths occurring within the first day following exposure to the substance. The mortality rate was the highest in male rats. Clinical signs of adverse effects and weight loss were observed in surviving animals from the highest dose groups. These effects did not revert by the end of the observation period (14 days). At necropsy significant pulmonary abnormalities in the surviving animals from the highest dose groups were identified. The LC50 was 1.6 ppm for male rats and 3.5 ppm for female rats. The substance meets the criteria for classification as Acute Tox 1, H330 according to Regulation (EC) N° 1272/2008. This classification is more severe than the current Harmonised Classification, in accordance with Annex VI Section 1.2 of Regulation (EC) N° 1272/2008.   No reliable study was identified to be used as a key study to assess the acute toxicity of Hexachlorocyclopentadiene via the dermal route. Therefore a weight-of-evidence approach was used based on available information on the acute dermal toxicity of the substance. No evidence was found indicating that Hexachlorocyclopentadiene should receive a more severe classification than the current Harmonised Classification as Acute Tox. 3; H311 for the dermal route. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The key study was considered as reliable as it is carried out using a procedure equivalent the OECD Guideline 403, and the results are supported by additional supporting studies reaching a similar conclusion. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The key study was considered as reliable as it is carried out using a procedure equivalent the OECD Guideline 401, and the results are supported by additional supporting studies reaching a similar conclusion. The LC50 of 1.6 ppm observed on male rats was converted in mg/m3. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Hexachlorocyclopentadiene is classified as Acute Tox. 3; H311. In accordance with the CLP Regulation the converted acute toxicity estimate for substances classified as Acute Tox. 3; H311 is 300 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7c83fa2-327a-433b-b4b9-c36222ba613e/documents/4ff43881-c469-4444-b199-2ff3e05c1f27_d6e73ce0-4431-41d2-a162-628dd2b493cf.html,,,,,, Hexachlorocyclopentadiene,77-47-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7c83fa2-327a-433b-b4b9-c36222ba613e/documents/4ff43881-c469-4444-b199-2ff3e05c1f27_d6e73ce0-4431-41d2-a162-628dd2b493cf.html,,oral,LD50,"1,400 mg/kg bw",adverse effect observed, Hexachlorocyclopentadiene,77-47-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7c83fa2-327a-433b-b4b9-c36222ba613e/documents/4ff43881-c469-4444-b199-2ff3e05c1f27_d6e73ce0-4431-41d2-a162-628dd2b493cf.html,,dermal,LD50,300 mg/kg bw,adverse effect observed, Hexachlorocyclopentadiene,77-47-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7c83fa2-327a-433b-b4b9-c36222ba613e/documents/4ff43881-c469-4444-b199-2ff3e05c1f27_d6e73ce0-4431-41d2-a162-628dd2b493cf.html,,inhalation,LC50,17.87 mg/m3,adverse effect observed, Hexachlorodisilane,13465-77-5," No data are available for the repeated dose oral toxicity of hexachlorodisilane, therefore good quality data for the hydrolysis product, polysilicic acid (equivalent to SAS) have been read-across to address the potential for systemic toxicity. In a repeat dose 90-day oral toxicity study (Kim et al., 2014) with Sprague-Dawley rats, two forms of synthetic amorphous silica (SAS and NM-202; differing in particle size and specific surface area) were administered (vehicle: water) by oral gavage for 90 consecutive days at a dose of 500, 1000 or 2000 mg/kg bw/day (10 animals/sex/group). The particles were described as either 20 or 100 nm in diameter. Extra animals were included in the control (received water only) and highest dose groups to allow for a two-week post-exposure recovery period. Observations were made according to OECD TG 408. For 20 and 100 nm silica samples the findings were sporadic and without a dose-response, so were concluded by the study authors not to be treatment-related. The NOAEL for both particle sizes was therefore concluded to be ≥2000 mg/kg bw/day. For local effects a good quality study on hydrogen chloride is available. In a 90-day repeated dose inhalation study in rats and mice (Toxigenics, 1983), 31 males and 21 females of each species/strain were exposed to test concentrations of 0, 10, 20 and 50 ppm hydrogen chloride gas (HCl). Treatment was whole-body exposure for six hour per day, 5 days per week. The No Observed Adverse Effect Concentration (NOAEC) for systemic effects was determined to be 20 ppm (approximately 30 mg/m3) based on decreased body weight following exposure to 50 ppm. No NOAEC for local effects was established as irritant/corrosive effects were observed at all dose levels tested. No suitable dermal data are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/156b1dc8-c3cb-4a7a-a2a2-b68a28c31288/documents/242e2b00-b015-4949-9992-6f0226901c34_c1133541-f360-4662-93db-af501a8f8bdd.html,,,,,, Hexachlorodisilane,13465-77-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/156b1dc8-c3cb-4a7a-a2a2-b68a28c31288/documents/242e2b00-b015-4949-9992-6f0226901c34_c1133541-f360-4662-93db-af501a8f8bdd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,000 mg/kg bw/day",,rat Hexachlorodisilane,13465-77-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/156b1dc8-c3cb-4a7a-a2a2-b68a28c31288/documents/242e2b00-b015-4949-9992-6f0226901c34_c1133541-f360-4662-93db-af501a8f8bdd.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 mg/m3,adverse effect observed,mouse Hexachlorodisilane,13465-77-5," In accordance with Column 2 of REACH Annexes VII and VIII, the acute oral toxicity study (required in Section 8.5.1) and an acute inhalation or dermal study (required in Section 8.5.2) do not need to be conducted as the substance is classified as corrosive to skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/156b1dc8-c3cb-4a7a-a2a2-b68a28c31288/documents/38a8c0d0-12b5-4f07-8f81-1051d15d60ac_c1133541-f360-4662-93db-af501a8f8bdd.html,,,,,, Hexachloroiridic acid,16941-92-7,"Oral: LD50: 690 mg/kg bw for rat (male and female) (Berthold, 1989). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab14f1e6-e5f6-416c-893b-066aeca3c375/documents/IUC5-d7dce728-d720-42d1-a15c-ad280b46d1cf_9bc1fb50-cc57-4492-a5eb-69baca792060.html,,,,,, Hexachloroiridic acid,16941-92-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab14f1e6-e5f6-416c-893b-066aeca3c375/documents/IUC5-d7dce728-d720-42d1-a15c-ad280b46d1cf_9bc1fb50-cc57-4492-a5eb-69baca792060.html,,oral,LD50,690 mg/kg bw,adverse effect observed, Hexadec-1-ene,629-73-2," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/578b8d29-aa6f-4c56-b4a9-f511a7bc1229/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_e60ef06e-4796-44f5-8bb8-46a27873fdc6.html,,,,,, Hexadec-1-ene,629-73-2,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/578b8d29-aa6f-4c56-b4a9-f511a7bc1229/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_e60ef06e-4796-44f5-8bb8-46a27873fdc6.html,,,,,, "Hexadecyl 3,5-bis-tert-butyl-4-hydroxybenzoate",67845-93-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1ed73ee-2e25-450c-a63a-ce2949e9ea6a/documents/IUC5-eadcada5-5915-4e1b-acee-4dea507851c7_38b605bb-9769-45c4-b4e1-6e911c341426.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,375 mg/kg bw/day,,rat "Hexadecyl 3,5-bis-tert-butyl-4-hydroxybenzoate",67845-93-6,"No mortality was observed in any reported studies, indicating very low acute toxicity via the oral and dermal exposure routes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1ed73ee-2e25-450c-a63a-ce2949e9ea6a/documents/IUC5-af3fc533-fa50-4dfa-9a4a-405b58069321_38b605bb-9769-45c4-b4e1-6e911c341426.html,,,,,, Hexadecyl chloroformate,26272-90-2,"LD50 is above 5000 mg/kg. The test substance, therefore, is practically non-toxic after swallowing. Inhalation of a saturated vapor atmosphere does not represent an acute health hazard. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ceb8957-8ae3-45c2-b62b-501f2b56d549/documents/IUC5-1f586c2c-6e7d-4d73-9992-09b7a4ab6cca_97a6a571-e736-4427-a14a-ff382ca16604.html,,,,,, Hexadecyl hydrogen maleate,2944-06-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/782ffda6-cda6-4e63-9639-b41ffc313109/documents/bffe26d0-ee6a-46ba-a44f-4407d5da2251_11404b2c-9053-4f8b-b6d8-dc952a979684.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,347 mg/kg bw/day,,rat Hexadecyl hydrogen maleate,2944-06-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/782ffda6-cda6-4e63-9639-b41ffc313109/documents/f21d8661-e933-4bd5-9c46-c4d1ae2a0b52_11404b2c-9053-4f8b-b6d8-dc952a979684.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Hexadecyl methacrylate,2495-27-4,"Subacute study; oral (gavage); rat (Sprague Dawley SD), m/f (OECD guideline 422, Klimisch score: 1,GLP), no toxicity occurred up to the highest administered dose of 1000 mg/kg/day with the structural analogue dodecyl methacrylate: NOAEL = 1000 mg/kg bw/d (CIT, 2007).With regard to the low repeated dose oral toxicity and the characteristics of skin penetration and metabolism in the skin, the repeated dose dermal toxicity can be considered as low. The inhalation route is not of relevance due to the very low vapour pressure of the substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ffc4a3c6-0ca0-4368-95a8-cbdc324659b1/documents/IUC5-6c79a2fb-4c20-4dab-aaf9-a89ec0c2d2a3_62190fd1-face-45e2-a0d3-615e33323327.html,,,,,, Hexadecyl methacrylate,2495-27-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ffc4a3c6-0ca0-4368-95a8-cbdc324659b1/documents/IUC5-6c79a2fb-4c20-4dab-aaf9-a89ec0c2d2a3_62190fd1-face-45e2-a0d3-615e33323327.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Hexadecyl methacrylate,2495-27-4,"The acute toxicity of hexadecyl methacrylate ester can be considered as very low as the acute toxicity of the structural analogue substance dodecyl methacrylate by the oral route was determined to be (LD50: > 5000 mg/kg, oral, rat, OECD 401, GLP, Klimisch score: 1) and dermal route (LD50: > 3000 mg/kg, Structurally related substance isodecyl methacrylate, dermal, rabbit, Klimisch score: 2). This experimentally observed result is supported by a dermal toxicity study with structural analogue dodecyl pentadecyl methacrylate where a LD50: > 5000 mg/kg, dermal, rabbit was observed. The inhalation route is not of relevance due to the very low vapour pressure (0.0064 hPa at 25 °C) of the structural analogue substance dodecyl methacrylate. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ffc4a3c6-0ca0-4368-95a8-cbdc324659b1/documents/IUC5-f1cf0ee4-6476-45c5-85b1-a3141d92c43d_62190fd1-face-45e2-a0d3-615e33323327.html,,,,,, Hexadecyl methacrylate,2495-27-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ffc4a3c6-0ca0-4368-95a8-cbdc324659b1/documents/IUC5-f1cf0ee4-6476-45c5-85b1-a3141d92c43d_62190fd1-face-45e2-a0d3-615e33323327.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Hexadecyl methacrylate,2495-27-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ffc4a3c6-0ca0-4368-95a8-cbdc324659b1/documents/IUC5-f1cf0ee4-6476-45c5-85b1-a3141d92c43d_62190fd1-face-45e2-a0d3-615e33323327.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, 1-hexadecylnaphthalene,56388-47-7, A well-conducted GLP OECD 422 study with an analogue of the substance indicated no adverse effects up to the maximum dose of 1000 mg/kg/day which was established as the NOAEL. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f0eccb1-2e6e-43cc-9a1b-7652c448de11/documents/07fa7bf5-5916-48ed-90c3-66acaa0ce735_9e268c39-3c9c-400a-a18d-f047328614fb.html,,,,,, 1-hexadecylnaphthalene,56388-47-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f0eccb1-2e6e-43cc-9a1b-7652c448de11/documents/07fa7bf5-5916-48ed-90c3-66acaa0ce735_9e268c39-3c9c-400a-a18d-f047328614fb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 1-hexadecylnaphthalene,56388-47-7, For the analogue the following data are available: Acute oral LD50 > 2000 mg/kg bw Acute dermal LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f0eccb1-2e6e-43cc-9a1b-7652c448de11/documents/4bebb4aa-83a7-4a44-b141-83e35305df8f_9e268c39-3c9c-400a-a18d-f047328614fb.html,,,,,, 1-hexadecylnaphthalene,56388-47-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f0eccb1-2e6e-43cc-9a1b-7652c448de11/documents/4bebb4aa-83a7-4a44-b141-83e35305df8f_9e268c39-3c9c-400a-a18d-f047328614fb.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 1-hexadecylnaphthalene,56388-47-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f0eccb1-2e6e-43cc-9a1b-7652c448de11/documents/4bebb4aa-83a7-4a44-b141-83e35305df8f_9e268c39-3c9c-400a-a18d-f047328614fb.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Hexafluoropropene, oxidized, oligomers, reduced, fluorinated",161075-00-9," The effects of GALDEN LMW following repeated administration by oral route were evaluated in a 28-day repeated dose toxicity study (OECD TG 408, GLP). The NOEL was > 1000 mg/kg/day (male/female). No adverse effects were noted. The effects following repeated exposure by inhalation were evaluated basing on the read across approach with the analogue substance H GALDEN, which was tested under a 28-day repeated dose toxicity study and a 90-day repeated dose toxicity study. Under all the reported studies, no adverse effects related to toxicity were detected. In conclusion GALDEN LMW is considered to have a low toxicity following repeated exposure both by oral route and by inhalation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8863ad56-a09b-48e2-aeb0-b1b947fa6980/documents/IUC5-20ab9e55-a740-4cea-a676-46661caf497d_a42ead08-6d42-4e11-81e9-1adfcdd3b8f9.html,,,,,, "Hexafluoropropene, oxidized, oligomers, reduced, fluorinated",161075-00-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8863ad56-a09b-48e2-aeb0-b1b947fa6980/documents/IUC5-20ab9e55-a740-4cea-a676-46661caf497d_a42ead08-6d42-4e11-81e9-1adfcdd3b8f9.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"115,209.37 mg/m3",,rat "Hexafluoropropene, oxidized, oligomers, reduced, fluorinated",161075-00-9," An oral toxicity study conducted according to OECD guideline No. 401 , a dermal toxicity study conducted according to OECD guideline No. 402 and an inhalation toxicity study conducted according to OECD guideline No. 403 are reported. All the three studies were conducted under GLP. The reliability of the studies according to Klimish score is K1. Basing on experimental results, according to REGULATION (EC) No 1272/2008, the substance does not meet the classification criteria for human health for acute toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8863ad56-a09b-48e2-aeb0-b1b947fa6980/documents/IUC5-f26b478d-cdc3-4da3-b965-929165257d21_a42ead08-6d42-4e11-81e9-1adfcdd3b8f9.html,,,,,, "Hexafluoropropene, oxidized, oligomers, reduced, fluorinated",161075-00-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8863ad56-a09b-48e2-aeb0-b1b947fa6980/documents/IUC5-f26b478d-cdc3-4da3-b965-929165257d21_a42ead08-6d42-4e11-81e9-1adfcdd3b8f9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hexafluoropropene, oxidized, oligomers, reduced, fluorinated",161075-00-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8863ad56-a09b-48e2-aeb0-b1b947fa6980/documents/IUC5-f26b478d-cdc3-4da3-b965-929165257d21_a42ead08-6d42-4e11-81e9-1adfcdd3b8f9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hexafluoropropene, oxidized, oligomers, reduced, fluorinated",161075-00-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8863ad56-a09b-48e2-aeb0-b1b947fa6980/documents/IUC5-f26b478d-cdc3-4da3-b965-929165257d21_a42ead08-6d42-4e11-81e9-1adfcdd3b8f9.html,,inhalation,LC50,"1,610 mg/m3",no adverse effect observed, Hexafluorosilicic acid,16961-83-4," No data are available for hexafluorosilic acid or sodium hexafluorosilicate. Comprehensive repeated dose oral toxicity data are available for sodium fluoride (NaF) by oral drinking water administration and for hydrogen fluoride (HF) by inhalation; read-across is therefore proposed. Chronic (6-month) oral exposure of NaF by drinking water to rats and mice resulted in a ‘target’ NOAEL of at least 4.56 mg/kg bw and ‘target’ LOAEL of at least 3.42 mg/kg bw, respectively. Systemic effects were increased fluoride content of plasma, bone and teeth leading to dental fluorosis in rats at higher dose levels, whereas in mice skeletal effects were seen from the lowest dose level in males. Subchronic (3-month) inhalation of HF in rats showed an overall NOAEL in male and female rats of 0.72 mg/m3 (actual HF concentration) for a 6 hours per 5 days per week for 91 days exposure regimen. This value corresponds to a corrected ‘target’ NOAEL of 0.18 mg/kg bw, which is considered to be very worst case source value the target substance HFS acid does not deposit deep in the lungs (see toxicokinetics). At higher concentrations death, tissue irritation, dental malformations, haematological and biological changes and changes in several organ weights were observed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/252551e8-8e51-430d-a05d-bbcd5797c95e/documents/1721dadf-5e96-4122-bbba-f4812b115914_177b2438-5dd6-4a69-b30c-14c404ed516f.html,,,,,, Hexafluorosilicic acid,16961-83-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/252551e8-8e51-430d-a05d-bbcd5797c95e/documents/1721dadf-5e96-4122-bbba-f4812b115914_177b2438-5dd6-4a69-b30c-14c404ed516f.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.72 mg/m3,,rat Hexafluorosilicic acid,16961-83-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/252551e8-8e51-430d-a05d-bbcd5797c95e/documents/1721dadf-5e96-4122-bbba-f4812b115914_177b2438-5dd6-4a69-b30c-14c404ed516f.html,Chronic toxicity – systemic effects,oral,LOAEL,3.42 mg/kg bw/day,,mouse Hexafluorosilicic acid,16961-83-4," No acute toxicity data have been identified for the substance: no testing has been performed and non is proposed. The substance is classified as H314 – Causes severe skin burns and eye damage according to CLP Regulation (No. 1272/2008 of 16 December 2008), therefore acute toxicity will be dominated by local (site of contact) irritant and corrosive effects. Testing of the substance for acute toxicity is not justified and was waived based on GLP Regulation Annex VII, column 2 specific rules of adaptation of 18 December 2006. The boundary composition reports that H2SiF6 may contain “Free hydrogen fluoride, expressed as HF (%): max 15 %on dry basis”. Hydrogen fluoride has a harmonized classification in place. Based on the classification of mixtures, classification shall therefore be given based on the % HF concentration. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/252551e8-8e51-430d-a05d-bbcd5797c95e/documents/38539f23-20df-40b3-9c4d-d0453c3fba64_177b2438-5dd6-4a69-b30c-14c404ed516f.html,,,,,, "Hexahydro-1,3,5-trimethyl-1,3,5-triazine",108-74-7," 28-day NOAEL (parental, rat) = 30 mg/kg bw/d, OECD 422, van Tuyl (2010) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c772d8f-f0a6-4b8a-9268-03f9967770ee/documents/9bbf9091-2de0-4454-8a45-1a18efceece6_4df932af-760d-4499-8f9d-bffabbc828f9.html,,,,,, "Hexahydro-1,3,5-trimethyl-1,3,5-triazine",108-74-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c772d8f-f0a6-4b8a-9268-03f9967770ee/documents/9bbf9091-2de0-4454-8a45-1a18efceece6_4df932af-760d-4499-8f9d-bffabbc828f9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "Hexahydro-1,3,5-trimethyl-1,3,5-triazine",108-74-7," Acute Oral Toxicity (rat) = 500 mg/kg bw, OECD 423, van Huygevoort (2010) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c772d8f-f0a6-4b8a-9268-03f9967770ee/documents/f7f212cc-ee11-4ac0-9fd6-e7e7b8a79550_4df932af-760d-4499-8f9d-bffabbc828f9.html,,,,,, "Hexahydro-1,3,5-trimethyl-1,3,5-triazine",108-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c772d8f-f0a6-4b8a-9268-03f9967770ee/documents/f7f212cc-ee11-4ac0-9fd6-e7e7b8a79550_4df932af-760d-4499-8f9d-bffabbc828f9.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "Hexahydro-2H-azepin-2-one, sodium salt",2123-24-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Based on hyaline-droplet degeneration of the proximal convoluted tubules in the kidneys, the NOAEL for males was found to be 29 mg/kg bw/day. In females, the NOAEL was 342 mg/kg bw based on increase in relative liver weights. The findings in male kidneys are supposed to be of no relevance for other species including humans (Haschek and Rousseaux, Fundamentals of Toxicologic Pathology, Academic Press, 1996). Therefore, CAP does not require any classification. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7cd7ec11-58d2-4916-a4d4-540dafa8a7c6/documents/IUC5-d7e4d099-27c8-4cb0-8903-e9ee6eb8f2ec_05c5a888-91ac-4328-a4ff-d42f9ca8121d.html,,,,,, "Hexahydro-2H-azepin-2-one, sodium salt",2123-24-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7cd7ec11-58d2-4916-a4d4-540dafa8a7c6/documents/IUC5-d7e4d099-27c8-4cb0-8903-e9ee6eb8f2ec_05c5a888-91ac-4328-a4ff-d42f9ca8121d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,350 mg/kg bw/day,,rat "Hexahydro-2H-azepin-2-one, sodium salt",2123-24-2," Acute toxicity, oral: Data from direct determination of toxicity of sodium caprolactamate as defined in section 1. Sodium caprolactamate is harmful if swallowed. LD50 oral (rat) = 300-2,000 mg/kg bw (female). For calculation the LD50 value 1450 mg/kg derived from epsilon-Caprolactam will be used. Acute toxicity, inhalative: Data from epsilon-Caprolactam will be used (a safety factor of 2 is applied): LC50 inhalative = 3.5 mg/L. Acute toxicity, dermal: The substance is corrosive to skin; therefore no toxicity data can be transferred from epsilon-Caprolactam. The substance has to be classified accordingly. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cd7ec11-58d2-4916-a4d4-540dafa8a7c6/documents/IUC5-937808f1-4759-437b-977d-d94f2b02f3fd_05c5a888-91ac-4328-a4ff-d42f9ca8121d.html,,,,,, "Hexahydro-2H-azepin-2-one, sodium salt",2123-24-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cd7ec11-58d2-4916-a4d4-540dafa8a7c6/documents/IUC5-937808f1-4759-437b-977d-d94f2b02f3fd_05c5a888-91ac-4328-a4ff-d42f9ca8121d.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, "Hexahydro-2H-azepin-2-one, sodium salt",2123-24-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cd7ec11-58d2-4916-a4d4-540dafa8a7c6/documents/IUC5-937808f1-4759-437b-977d-d94f2b02f3fd_05c5a888-91ac-4328-a4ff-d42f9ca8121d.html,,inhalation,LC50,"3,500 mg/m3",adverse effect observed, "Hexahydro-4,7-methano-1H-indenyl acrylate",12542-30-2,In a well-conducted OECD combined repeated dose and reproductive/developmental toxicity screening test with Dihydrodicyclopentadienylacrylate (OECD TG 422) by oral gavage in rats no toxicity occurred up to the highest administered dose of 1000 mg/kg bw/day. The NOAEL was determined to 1000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78b85afd-eb46-449a-be84-f4ee81bfb807/documents/IUC5-3a36c14e-eef9-4aa3-9994-f983a59abae1_8fcfa671-aae4-450b-9700-baad90a616ff.html,,,,,, "Hexahydro-4,7-methano-1H-indenyl acrylate",12542-30-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78b85afd-eb46-449a-be84-f4ee81bfb807/documents/IUC5-3a36c14e-eef9-4aa3-9994-f983a59abae1_8fcfa671-aae4-450b-9700-baad90a616ff.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hexahydro-4,7-methano-1H-indenyl acrylate",12542-30-2,"Dicyclopentadienyl acrylate is virtually nontoxic after a single ingestion and of low toxicity after short-term skin contact. The inhalation of a highly saturated vapour-air-mixture represents an unlikely acute hazard.Oral: LD50 = ca. 10000 mg/kg bw (Sprague-Dawley rat, BASF Test comparable to OECD TG 401)Dermal: LD50: ca. 4881 mg/kg bw (New Zealand White rabbit, occlusive)Inhalation: LC0 = approx. >= 1.0 mg/L (nominal, saturated vapour, 7 h) (Sprague-Dawley rat, IHT comparable to OECD 403, adopted 1981) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78b85afd-eb46-449a-be84-f4ee81bfb807/documents/IUC5-38cedceb-236e-4d41-8c11-514159ecb234_8fcfa671-aae4-450b-9700-baad90a616ff.html,,,,,, "Hexahydro-4,7-methano-1H-indenyl acrylate",12542-30-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78b85afd-eb46-449a-be84-f4ee81bfb807/documents/IUC5-38cedceb-236e-4d41-8c11-514159ecb234_8fcfa671-aae4-450b-9700-baad90a616ff.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "Hexahydro-4,7-methano-1H-indenyl acrylate",12542-30-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78b85afd-eb46-449a-be84-f4ee81bfb807/documents/IUC5-38cedceb-236e-4d41-8c11-514159ecb234_8fcfa671-aae4-450b-9700-baad90a616ff.html,,dermal,LD50,"4,881 mg/kg bw",no adverse effect observed, Hexahydro-4-methylphthalic anhydride,19438-60-9, A NOAEL of 450 mg/kg b.w./day was derived from a sub-chronic oral toxicity study with 4-MHHPA. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d12497cc-a52d-4bd7-b697-e1043dd20385/documents/IUC5-78b96985-bbc7-47e3-a202-449a04a53bd7_ad80da40-5bbc-43bf-8f81-477e6684ebf5.html,,,,,, Hexahydro-4-methylphthalic anhydride,19438-60-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d12497cc-a52d-4bd7-b697-e1043dd20385/documents/IUC5-78b96985-bbc7-47e3-a202-449a04a53bd7_ad80da40-5bbc-43bf-8f81-477e6684ebf5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat Hexahydro-4-methylphthalic anhydride,19438-60-9,Acute toxicity:Oral: LD50 = > 2000 mg/kg bwDermal LD50 = > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d12497cc-a52d-4bd7-b697-e1043dd20385/documents/IUC5-90b0cbae-c8c0-4f2f-8c3a-3c0f2b472cbe_ad80da40-5bbc-43bf-8f81-477e6684ebf5.html,,,,,, Hexahydro-4-methylphthalic anhydride,19438-60-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d12497cc-a52d-4bd7-b697-e1043dd20385/documents/IUC5-90b0cbae-c8c0-4f2f-8c3a-3c0f2b472cbe_ad80da40-5bbc-43bf-8f81-477e6684ebf5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Hexahydro-4-methylphthalic anhydride,19438-60-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d12497cc-a52d-4bd7-b697-e1043dd20385/documents/IUC5-90b0cbae-c8c0-4f2f-8c3a-3c0f2b472cbe_ad80da40-5bbc-43bf-8f81-477e6684ebf5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Hexakis[μ-(acetato-O:O')]-μ3-oxo-triangulo-triruthenium acetate,55466-76-7," In a 4-week repeated dose toxicity study, to GLP, ruthenium acetate was administered by gavage to CD rats at 15, 150 or 1000 mg/kg bw/day. Effects at 1000 mg/kg bw/day exceeded the maximum tolerated dose and the study was terminated prematurely at week 3. The lower doses were generally well tolerated with findings restricted to minor variations in clinical pathology parameters and effects on the spleen. Although considered of low-severity, the effects on the spleen (enlargement in males and histopathological change) increased in incidence affecting one, to ""several"", to the ""majority"", of animals in the low-, mid- and high-dose groups, respectively. The low dose of 15 mg/kg bw/day is therefore considered the most appropriate to assign as the study NOAEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9889f4e9-4329-4146-8a44-1b885bef8955/documents/665581c1-ab1c-4be9-a2dd-723b6c9f20f9_f3d7d36f-567f-4418-a318-83a1b714a3f0.html,,,,,, Hexakis[μ-(acetato-O:O')]-μ3-oxo-triangulo-triruthenium acetate,55466-76-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9889f4e9-4329-4146-8a44-1b885bef8955/documents/665581c1-ab1c-4be9-a2dd-723b6c9f20f9_f3d7d36f-567f-4418-a318-83a1b714a3f0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat Hexakis[μ-(acetato-O:O')]-μ3-oxo-triangulo-triruthenium acetate,55466-76-7," In a guideline study, to GLP, the acute oral LD50 of ruthenium acetate was determined to be greater than 2000 mg/kg bw (Allen, 1995a). In a guideline study, to GLP, the acute dermal LD50 of ruthenium acetate was determined to exceed 2000 mg/kg bw , as no deaths occurred at this limit dose (Sanders, 2004). No relevant acute inhalation toxicity data were identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9889f4e9-4329-4146-8a44-1b885bef8955/documents/IUC5-3a6cc358-ec41-4490-be08-c0fa519c6581_f3d7d36f-567f-4418-a318-83a1b714a3f0.html,,,,,, Hexakis[μ-(acetato-O:O')]-μ3-oxo-triangulo-triruthenium acetate,55466-76-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9889f4e9-4329-4146-8a44-1b885bef8955/documents/IUC5-3a6cc358-ec41-4490-be08-c0fa519c6581_f3d7d36f-567f-4418-a318-83a1b714a3f0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Hexakis[μ-(acetato-O:O')]-μ3-oxo-triangulo-triruthenium acetate,55466-76-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9889f4e9-4329-4146-8a44-1b885bef8955/documents/IUC5-3a6cc358-ec41-4490-be08-c0fa519c6581_f3d7d36f-567f-4418-a318-83a1b714a3f0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Hexamethylcyclotrisiloxane,541-05-9," In the key 90-day inhalation repeated dose toxicity study, conducted according to OECD Test Guideline 413 and in compliance with GLP, the NOAEC for systemic toxicity, concluded by the study authors, was 150 ppm (1400 mg/m3) hexamethylcyclotrisiloxane vapour (D3; CAS 541-05-9; EC No. 208-765-4) for male and female rats based on clinical signs, body weight changes, effects on blood and clinical biochemistry parameters, organ weights and histopathology at 600 ppm and higher. The test substance-related effects at concentrations up to 150 ppm were considered transitory, adaptive/metabolic, not clearly adverse or giving no evidence of organ toxicity. The reviewer of the study, however, concluded that the true NOAEC for systemic toxicity in male and female rats is at least 600 ppm (equivalent to 5459 mg/m3) based on not fully reversible statistically significant changes in body weights, haematology and blood chemistry parameters seen in 2500 ppm recovery male rats as well as not fully reversible statistically significantly increased liver / body weight ratio seen in recovery males and females from 2500 ppm group. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d1d108f5-b5df-4cdf-a03f-a26777943e34/documents/6cc037cd-240d-4655-9626-df7350af952c_a33364df-9025-46ea-90bf-3c7853fe0e10.html,,,,,, Hexamethylcyclotrisiloxane,541-05-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d1d108f5-b5df-4cdf-a03f-a26777943e34/documents/6cc037cd-240d-4655-9626-df7350af952c_a33364df-9025-46ea-90bf-3c7853fe0e10.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"5,459 mg/m3",,rat Hexamethylcyclotrisiloxane,541-05-9," There are no reliable acute oral toxicity data available for hexamethylcyclotrisiloxane (D3; CAS no. 541-05-9; EC No. 208-765-4 ), therefore all the available key acute oral toxicity data for other analogue cyclic siloxanes (octamethylcyclotetrasiloxane (D4; CAS No. 556-67-2; EC No. 209-136-7); decamethylcyclopentasiloxane (D5; CAS No. 541-02-6; EC No. 208-764-9); dodecamethylcyclohexasiloxane (D6; CAS No. 540-97-6; EC No. 208-762-8)) have been read across as a weight of evidence. See attachment to Section 13 for justification of read-across.   In the acute oral toxicity study with octamethylcyclotetrasiloxane (D4) in male rats (Bayer AG, 1979), conducted according to a protocol similar to the now-deleted OECD Test Guideline 401, but prior to GLP compliance, the LD50 was greater than 4800 mg/kg bw.    In the acute oral toxicity study with decamethylcyclopentasiloxane (D5) (Toxikon Corporation, 1990), conducted according to a protocol similar to the now-deleted OECD Test Guideline 401 and in compliance with GLP, the LD50 value for male and female rats was >5000 mg/kg bw. In the acute oral toxicity study with dodecamethylcyclohexasiloxane (D6) (NOTOX, 1999), conducted according to OECD Test Guideline 423 and in compliance with GLP, the LD50 value was >2000 mg/kg bw. No acute inhalation tests are available for D3. However, a repeated dose toxicity study via the inhalation route (Dow Corning Corporation, 2001) tested D3 at exposure levels up to the maximum attainable vapour concentration for this substance, for a duration of 6 hours per day for 90 days. There was no mortality or evidence of specific target organ toxicity in this study. It can therefore be concluded that D3 would not be acutely toxic by the inhalation route up to the maximum attainable vapour concentration.    No data are available for the dermal route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1d108f5-b5df-4cdf-a03f-a26777943e34/documents/4507940b-39ae-4307-a70e-1b3d57b61c63_a33364df-9025-46ea-90bf-3c7853fe0e10.html,,,,,, Hexamethylcyclotrisiloxane,541-05-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1d108f5-b5df-4cdf-a03f-a26777943e34/documents/4507940b-39ae-4307-a70e-1b3d57b61c63_a33364df-9025-46ea-90bf-3c7853fe0e10.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]",35074-77-2,"In rats, the substance targets the liver and activates the well described liver-thyroid axis resulting in higher thyroid activity as reflected by organ size and follicular hypertrophy. As expected, this species specific effect on the thyroid was not observed in dogs up to the highest dose levels tested. Since this mechanis is not relevant for humans, the dog study was considered as the most relevant study for risk assessment. In this 90d feeding study, adaptive liver increases were the only findings, the NOAEL was dermined at 147 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b65345eb-c9bb-44da-9a1d-3ac8a5a62182/documents/IUC5-f7429201-3de5-4d41-9005-c54e9ab1c14f_aad272ab-cba4-4c61-a2fd-3401f3c0d9ae.html,,,,,, "Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]",35074-77-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b65345eb-c9bb-44da-9a1d-3ac8a5a62182/documents/IUC5-f7429201-3de5-4d41-9005-c54e9ab1c14f_aad272ab-cba4-4c61-a2fd-3401f3c0d9ae.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,148.7 mg/kg bw/day,,dog "Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]",35074-77-2,"In four acute oral toxicity studies LD50 values of greater than 5000 mg/kg bw were determined for several species (hamster, mouse and rat). No mortality was observed in any of the tested species. In an acute inhalation study a LC50 of greater than 1700 mg/m3 air (aerosol, maximum attainable concentration) was determined in rats. A dermal LD50 of greater than 10000 mg/kg bw was determined and no mortality was observed in an acute dermal toxicity study with rabbits. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b65345eb-c9bb-44da-9a1d-3ac8a5a62182/documents/IUC5-54e593ea-6e59-4fea-be70-a4af019e5d82_aad272ab-cba4-4c61-a2fd-3401f3c0d9ae.html,,,,,, "Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]",35074-77-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b65345eb-c9bb-44da-9a1d-3ac8a5a62182/documents/IUC5-54e593ea-6e59-4fea-be70-a4af019e5d82_aad272ab-cba4-4c61-a2fd-3401f3c0d9ae.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]",35074-77-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b65345eb-c9bb-44da-9a1d-3ac8a5a62182/documents/IUC5-54e593ea-6e59-4fea-be70-a4af019e5d82_aad272ab-cba4-4c61-a2fd-3401f3c0d9ae.html,,dermal,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "Hexamethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]",35074-77-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b65345eb-c9bb-44da-9a1d-3ac8a5a62182/documents/IUC5-54e593ea-6e59-4fea-be70-a4af019e5d82_aad272ab-cba4-4c61-a2fd-3401f3c0d9ae.html,,inhalation,discriminating conc.,"1,700 mg/m3",no adverse effect observed, Hexamethylene diacrylate,13048-33-4," Oral: Rat:(OECD 422): NOAEL (systemic) = 250 mg/kg bw/d (ReachCentrum SPRL, 2010) Read-across to CAS No. 42978-66-5 Rat: (OECD 422): NOAEL= 375 mg/kg bw/day (ReachCentrum, 2019b) Dermal: Read-across to CAS No. 42978-66-5 Rat: subchronic 3 months: NOAEL (systemic) = 66.66 mg/kg bw/d; LOAEL (local) = 20 mg/kg bw/d (Bio/Dynamics Inc., 1992) Inhalation: No data available ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/964486ed-a84e-4567-8d1c-5d0659fbdd82/documents/IUC5-95c9171b-265c-4ca7-ba22-02c7b935f04c_55a5aa62-9e50-412c-a298-b5415f45edc3.html,,,,,, Hexamethylene diacrylate,13048-33-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/964486ed-a84e-4567-8d1c-5d0659fbdd82/documents/IUC5-95c9171b-265c-4ca7-ba22-02c7b935f04c_55a5aa62-9e50-412c-a298-b5415f45edc3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Hexamethylene diacrylate,13048-33-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/964486ed-a84e-4567-8d1c-5d0659fbdd82/documents/IUC5-95c9171b-265c-4ca7-ba22-02c7b935f04c_55a5aa62-9e50-412c-a298-b5415f45edc3.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,66.66 mg/kg bw/day,,rat Hexamethylene diacrylate,13048-33-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/964486ed-a84e-4567-8d1c-5d0659fbdd82/documents/IUC5-95c9171b-265c-4ca7-ba22-02c7b935f04c_55a5aa62-9e50-412c-a298-b5415f45edc3.html,Repeated dose toxicity – local effects,dermal,LOAEL,0.11 mg/cm2,adverse effect observed,rat Hexamethylene diacrylate,13048-33-4," Oral: LD50 (rat) > 5000 mg/kg bw (comp. OECD 401) (BASF, 1979) Inhalation: Rat, IHT: 7 h: LC50 > 0.41 mg/l air (BASF, 1979) Dermal: Rabbit: LD50 = 3650 mg/kg bw (Litton Bionetics, 1972) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/964486ed-a84e-4567-8d1c-5d0659fbdd82/documents/IUC5-9cec3d27-43ab-40a1-994c-851c66baca3f_55a5aa62-9e50-412c-a298-b5415f45edc3.html,,,,,, Hexamethylene diacrylate,13048-33-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/964486ed-a84e-4567-8d1c-5d0659fbdd82/documents/IUC5-9cec3d27-43ab-40a1-994c-851c66baca3f_55a5aa62-9e50-412c-a298-b5415f45edc3.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Hexamethylene diacrylate,13048-33-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/964486ed-a84e-4567-8d1c-5d0659fbdd82/documents/IUC5-9cec3d27-43ab-40a1-994c-851c66baca3f_55a5aa62-9e50-412c-a298-b5415f45edc3.html,,dermal,LD50,"3,650 mg/kg bw",adverse effect observed, Hexamethylene diacrylate,13048-33-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/964486ed-a84e-4567-8d1c-5d0659fbdd82/documents/IUC5-9cec3d27-43ab-40a1-994c-851c66baca3f_55a5aa62-9e50-412c-a298-b5415f45edc3.html,,inhalation,discriminating conc.,0 mg/m3,no adverse effect observed, "Hexamethylene diisocyanate, oligomers, reaction products with 3-methoxypropylamine",162492-07-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8275a772-d435-4ffb-9e36-e50a60647539/documents/ca6717f0-5c50-4f1a-8fde-39010eee4137_48c52675-5c39-4aa6-aeaa-77841ba2a2c2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hexamethylene diisocyanate, oligomers, reaction products with 3-methoxypropylamine",162492-07-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8275a772-d435-4ffb-9e36-e50a60647539/documents/27e578f6-82a5-46d3-9658-12e93334b793_48c52675-5c39-4aa6-aeaa-77841ba2a2c2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hexamethylene diisocyanate, trimers, reaction products with 2-hydroxyethyl acrylate",162492-01-5," Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test, oral (OECD 422), rat: NOAEL = 1000 mg/kg bw/day for males and females ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3202622-cf69-4876-981c-d981945eb5f2/documents/556a394b-9823-4ce5-9883-b5d75fe3c0da_c7f42033-efbc-4fa9-9cda-9e08941b5dbe.html,,,,,, "Hexamethylene diisocyanate, trimers, reaction products with 2-hydroxyethyl acrylate",162492-01-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3202622-cf69-4876-981c-d981945eb5f2/documents/556a394b-9823-4ce5-9883-b5d75fe3c0da_c7f42033-efbc-4fa9-9cda-9e08941b5dbe.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hexamethylene diisocyanate, trimers, reaction products with 2-hydroxyethyl acrylate",162492-01-5," Oral (OECD 423), rat: LD50 cut-off 5000 mg/kg bw Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3202622-cf69-4876-981c-d981945eb5f2/documents/a4bccca0-b549-489e-91d9-b920a90efb8b_c7f42033-efbc-4fa9-9cda-9e08941b5dbe.html,,,,,, "Hexamethylene diisocyanate, trimers, reaction products with 2-hydroxyethyl acrylate",162492-01-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3202622-cf69-4876-981c-d981945eb5f2/documents/a4bccca0-b549-489e-91d9-b920a90efb8b_c7f42033-efbc-4fa9-9cda-9e08941b5dbe.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hexamethylene diisocyanate, trimers, reaction products with 2-hydroxyethyl acrylate",162492-01-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3202622-cf69-4876-981c-d981945eb5f2/documents/a4bccca0-b549-489e-91d9-b920a90efb8b_c7f42033-efbc-4fa9-9cda-9e08941b5dbe.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N-(2-ethylhexyl)-3,5,5-trimethylhexanamide",1700656-13-8,"OECD 408 Study (oral, rat): NOAEL (no-observed-adverse-effect- level) = 1000 mg/kg body weight/day OECD 407 Study (oral, rat): NOAEL (no-observed-adverse-effect- level) = 1000 mg/kg body weight/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d61a033-f9ee-4fb6-bac6-ce84b66f24c6/documents/809f2fcf-9c4e-4e3b-a072-8a7b0228b540_5ada2612-8df1-4822-a66e-36f2cbba2cec.html,,,,,, "N-(2-ethylhexyl)-3,5,5-trimethylhexanamide",1700656-13-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d61a033-f9ee-4fb6-bac6-ce84b66f24c6/documents/809f2fcf-9c4e-4e3b-a072-8a7b0228b540_5ada2612-8df1-4822-a66e-36f2cbba2cec.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N-(2-ethylhexyl)-3,5,5-trimethylhexanamide",1700656-13-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d61a033-f9ee-4fb6-bac6-ce84b66f24c6/documents/809f2fcf-9c4e-4e3b-a072-8a7b0228b540_5ada2612-8df1-4822-a66e-36f2cbba2cec.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N-(2-ethylhexyl)-3,5,5-trimethylhexanamide",1700656-13-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Data reliable and meet criteria for classification & labelling requirements. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d61a033-f9ee-4fb6-bac6-ce84b66f24c6/documents/5948f219-9a4f-47f7-9b25-a9524eeb7f50_5ada2612-8df1-4822-a66e-36f2cbba2cec.html,,,,,, "N-(2-ethylhexyl)-3,5,5-trimethylhexanamide",1700656-13-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d61a033-f9ee-4fb6-bac6-ce84b66f24c6/documents/5948f219-9a4f-47f7-9b25-a9524eeb7f50_5ada2612-8df1-4822-a66e-36f2cbba2cec.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N-(2-hydroxyethyl)-3,5,5-trimethylhexanamide",1154308-86-7," Based on the results of the screening study, no toxicologically significant systemic toxicity is expected for the test substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d25c8a5-5abc-4c24-a110-8c28ea622536/documents/0553cde4-48cf-43c1-8504-b20041becc81_2cf44bc2-1f30-42ca-a216-2f2d7058d21a.html,,,,,, "N-(2-hydroxyethyl)-3,5,5-trimethylhexanamide",1154308-86-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d25c8a5-5abc-4c24-a110-8c28ea622536/documents/0553cde4-48cf-43c1-8504-b20041becc81_2cf44bc2-1f30-42ca-a216-2f2d7058d21a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "N-(2-hydroxyethyl)-3,5,5-trimethylhexanamide",1154308-86-7,"Based on the oral and dermal LD50 values, the test substance is considered to have a low acute toxicity potential. a moderate acute toxicity potential. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d25c8a5-5abc-4c24-a110-8c28ea622536/documents/df25c9f6-9c97-4621-b79e-c638aca5a1c2_2cf44bc2-1f30-42ca-a216-2f2d7058d21a.html,,,,,, "N-(2-hydroxyethyl)-3,5,5-trimethylhexanamide",1154308-86-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d25c8a5-5abc-4c24-a110-8c28ea622536/documents/df25c9f6-9c97-4621-b79e-c638aca5a1c2_2cf44bc2-1f30-42ca-a216-2f2d7058d21a.html,,oral,LD50,"ca.2,000 mg/kg bw",adverse effect observed, "N-(2-hydroxyethyl)-3,5,5-trimethylhexanamide",1154308-86-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d25c8a5-5abc-4c24-a110-8c28ea622536/documents/df25c9f6-9c97-4621-b79e-c638aca5a1c2_2cf44bc2-1f30-42ca-a216-2f2d7058d21a.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Hexane, 1,6-diisocyanato-, homopolymer, 2-hydroxyethyl acrylate- and propylene glycol monoacrylate-blocked",1392411-89-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/072d8878-dd84-4146-a0a0-1f23bb54a189/documents/d1764154-277d-4878-8fed-ba58e1e8a073_651d16d1-acaf-497f-91e0-ad1287b6c6a5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hexane, 1,6-diisocyanato-, homopolymer, 2-hydroxyethyl acrylate- and propylene glycol monoacrylate-blocked",1392411-89-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/072d8878-dd84-4146-a0a0-1f23bb54a189/documents/a2fb9e9b-4ba9-4618-bf7e-7eeee3113bb4_651d16d1-acaf-497f-91e0-ad1287b6c6a5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hexamethylene diisocyanate, oligomerisation product, blocked with N-butyl-1-butanamine",1190401-47-8,"OECD 422 (WIL Research Europe), NOEAL = 1000 mg/kg (systemic and local) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21ad6e78-576d-495a-a7c8-103a61729a7d/documents/IUC5-532ace48-7175-4182-a01e-5eb01d4325fa_0e828f56-ff70-4593-ba11-4bcbbf494387.html,,,,,, "Hexamethylene diisocyanate, oligomerisation product, blocked with N-butyl-1-butanamine",1190401-47-8,"The acute oral LD50 of Hexane, 1,6-diisocyanato, homopolymer, N-butyl-1-butanamine-blocked after single oral administration to female rats is > 2000 mg/kg bw.The acute dermal LD50 of Hexane, 1,6-diisocyanato, homopolymer, N-butyl-1-butanamine-blocked after single dermal application in male and female rats is > 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21ad6e78-576d-495a-a7c8-103a61729a7d/documents/IUC5-c9540a30-a264-498c-9c2c-921391d8f68d_0e828f56-ff70-4593-ba11-4bcbbf494387.html,,,,,, "2,2,4(or 2,4,4)-Trimethylhexane-1,6-diisocyanate",32052-51-0,"A sub-chronic toxicity study (90 -day), via inhalation route in rats (acc. OECD 413) was conducted upon request by a final decision on testing proposals pursuant to article 40 (3) of regulation (EC) No 1907/2006 by the competent authority. There are several repeated dose inhalation toxicity studies available:  Kimmerle_1972_rats I/II and  Vivotecnia_DRF_3 -week and 13 -week inhalation toxicity study 2017 and 2018 Under the conditions employed in the 28 -day inhalation toxicity study (Kimmerle 1972) the No-Observed-Adverse- Effect-Level (NOAEL) for rats is determined to be 0.34 mg/m3 air. Under the conditions employed in the 3 -week DRF inhalation toxicity study (Vivotecnia 2017) the No-Observed-Adverse- Effect-Concentration (NOAEC) for rats is determined to be 1 mg/m3 air. This value was validated in a 90 day inhalation toxicity study (Vivotecnia 2018). The No-Observed-Adverse- Effect-Concentration (NOAEC) for rats was confirmed to be 1 mg/m3 air. Based on these results the DNEL was adapted from 0,019 to 0,084 mg/ m3. These results are based on pre-final report by VVT 2019. No repeated-dose toxicity tests are available for the oral and dermal route of exposure. Data waiver are claimed. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Vivotecnia_2017 and 2018 studies are valid without restrictions (Klimisch score 1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Vivotecnia_2017 and 2018 studies are valid without restrictions (Klimisch score 1) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7f78cb0b-4f21-4f61-b000-538b29fe9a12/documents/IUC5-52b5ef16-80a0-4318-8999-1ead9dedbeb8_c5f6a84e-b1b9-4c1b-92ef-7f1b237b1064.html,,,,,, "2,2,4(or 2,4,4)-Trimethylhexane-1,6-diisocyanate",32052-51-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7f78cb0b-4f21-4f61-b000-538b29fe9a12/documents/IUC5-52b5ef16-80a0-4318-8999-1ead9dedbeb8_c5f6a84e-b1b9-4c1b-92ef-7f1b237b1064.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1 mg/m3,adverse effect observed,rat "2,2,4(or 2,4,4)-Trimethylhexane-1,6-diisocyanate",32052-51-0,"2,2,4(or2,4,4)-trimethylhexane-1,6 -diisocyanate is of low oral and dermal acute toxicity in rats, whereas the acute inhalation toxicity data indicate that exposure to respirable aerosols of 2,2,4(or2,4,4)-trimethylhexane-1,6 -diisocyanate is limited to the respiratory tract. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Study is comparable to guideline study , supporting studies are well documented and meet generally accepted scientific principles, Klimisch Score 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Guideline study with acceptable restrictions: no air control animals; exposure concentrations spaced suboptimal, Klimisch Score 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Guideline study, Klimisch score 1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f78cb0b-4f21-4f61-b000-538b29fe9a12/documents/IUC5-8e4325b5-d5cc-480d-a046-92f8bd905b15_c5f6a84e-b1b9-4c1b-92ef-7f1b237b1064.html,,,,,, "2,2,4(or 2,4,4)-Trimethylhexane-1,6-diisocyanate",32052-51-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f78cb0b-4f21-4f61-b000-538b29fe9a12/documents/IUC5-8e4325b5-d5cc-480d-a046-92f8bd905b15_c5f6a84e-b1b9-4c1b-92ef-7f1b237b1064.html,,oral,LD50,"4,800 mg/kg bw",no adverse effect observed, "2,2,4(or 2,4,4)-Trimethylhexane-1,6-diisocyanate",32052-51-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f78cb0b-4f21-4f61-b000-538b29fe9a12/documents/IUC5-8e4325b5-d5cc-480d-a046-92f8bd905b15_c5f6a84e-b1b9-4c1b-92ef-7f1b237b1064.html,,dermal,LD50,"7,000 mg/kg bw",adverse effect observed, "2,2,4(or 2,4,4)-Trimethylhexane-1,6-diisocyanate",32052-51-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f78cb0b-4f21-4f61-b000-538b29fe9a12/documents/IUC5-8e4325b5-d5cc-480d-a046-92f8bd905b15_c5f6a84e-b1b9-4c1b-92ef-7f1b237b1064.html,,inhalation,LC50,50 mg/m3,adverse effect observed, "Hexane-1,3,6-tricarbonitrile",1772-25-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): high ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/feb290d1-118e-48fc-ad2e-c925786829df/documents/1436fc69-654a-4c58-b389-4b832f42942b_1fa82610-7d16-46f8-9a2f-38dfc68f6644.html,,,,,, "Hexane-1,3,6-tricarbonitrile",1772-25-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/feb290d1-118e-48fc-ad2e-c925786829df/documents/1436fc69-654a-4c58-b389-4b832f42942b_1fa82610-7d16-46f8-9a2f-38dfc68f6644.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Hexane-1,3,6-tricarbonitrile",1772-25-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/feb290d1-118e-48fc-ad2e-c925786829df/documents/48d870a9-f755-4b3e-9522-068aa645a97a_1fa82610-7d16-46f8-9a2f-38dfc68f6644.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "Hexane-1,3,6-tricarbonitrile",1772-25-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/feb290d1-118e-48fc-ad2e-c925786829df/documents/48d870a9-f755-4b3e-9522-068aa645a97a_1fa82610-7d16-46f8-9a2f-38dfc68f6644.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1,6-Di(trimethoxysilylpropyl carbamoyloxy) hexan",501925-98-0,"The test substance is of low oral acute toxicity with an oral LD50 (rat) of > 2000 mg/kg bw (LPT, 2013). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eefe60ee-78bd-49e1-930d-2c9853893ff8/documents/IUC5-61898e6e-bdee-4375-bb63-96250e46334d_f89ef135-f8bf-484f-bc7f-14bc4e30d6b0.html,,,,,, "1,6-Di(trimethoxysilylpropyl carbamoyloxy) hexan",501925-98-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eefe60ee-78bd-49e1-930d-2c9853893ff8/documents/IUC5-61898e6e-bdee-4375-bb63-96250e46334d_f89ef135-f8bf-484f-bc7f-14bc4e30d6b0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "reaction mass of dimethyl 2,2,4-trimethylhexanedioate and dimethyl 2,4,4-trimethylhexanedioate",201872-72-2,The acute oral toxicity to rats was evaluated by acute toxic class method. The test item was administerd to six female rats in a single dose by gavage at a dose fo 2000 mg/kg body weight. The animals were observed for mortality and any sub-lethal effects for 14 days after dosing. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f17a8a7-03c9-4983-8bbc-bcb0fac27f7f/documents/IUC5-170ccb76-c784-4895-8c54-fcdd6adab4b7_b050830e-2537-4c35-b91d-c319138b2262.html,,,,,, "Reaction products of adipic acid, 2-(2-methoxyethoxy)ethanol and phenylmethanol",1175612-76-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): A single study (Sanders) is available for the assessment. The data is of K1 quality and adequate for hazard assessment and classification of the substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9d4c8ab-d068-407d-a954-764239dd01da/documents/IUC5-aff76df3-0b26-47bf-9b65-5e54cdc24bcd_b05033e1-a629-47d6-845e-29e160b1a9a8.html,,,,,, "Reaction products of adipic acid, 2-(2-methoxyethoxy)ethanol and phenylmethanol",1175612-76-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d9d4c8ab-d068-407d-a954-764239dd01da/documents/IUC5-aff76df3-0b26-47bf-9b65-5e54cdc24bcd_b05033e1-a629-47d6-845e-29e160b1a9a8.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "Hexanoic acid, 2-ethyl-, zinc salt, basic",85203-81-2,"The LD50 of Hexanoic acid, 2-ethyl-, zinc salt, basic via oral and dermal route is >2000mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93d36f7b-523d-4617-a5b5-1b26be411fad/documents/7dadc941-04de-443a-954e-75776d7d5b3f_e45355d5-b510-4fdc-b0ff-674351ae90b8.html,,,,,, "2-ethyl-2-(((3,5,5-trimethylhexanoyl)oxy)methyl)propane-1,3-diyl bis(3,5,5-trimethylhexanoate)",65870-94-2,"Based on the in-life results and histopathology findings, a dose level of 1000 mg/kg bw/day is considered to be a No Observed Adverse Effect Level (NOAEL) for systemic toxicity (OECD 407). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22c24628-3ce0-461a-919b-bb6146e1af45/documents/IUC5-a2b59f25-2215-4a8b-8445-44f2512287ea_fdef6168-d35d-4cd9-aca0-44d01683aab9.html,,,,,, "2-ethyl-2-(((3,5,5-trimethylhexanoyl)oxy)methyl)propane-1,3-diyl bis(3,5,5-trimethylhexanoate)",65870-94-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22c24628-3ce0-461a-919b-bb6146e1af45/documents/IUC5-a2b59f25-2215-4a8b-8445-44f2512287ea_fdef6168-d35d-4cd9-aca0-44d01683aab9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-ethyl-2-(((3,5,5-trimethylhexanoyl)oxy)methyl)propane-1,3-diyl bis(3,5,5-trimethylhexanoate)",65870-94-2,"OralKey, LD50 oral > 2000 mg/kg bw (test item), Sanders, 2013Supporting, LD 50 oral > 2000 mg/kg bw (EC 234-392-1), Clouzeau, 1990Supporting, LD50 oral >2000 mg/kg bw (CAS 85116-93-4), Potokar, 1983Supporting, LD50 oral >2000 mg/kg bw (CAS 68424-31-7), Robinson, 1991Supporting, LD50 oral >2000 mg/kg bw CAS 131459-39-7, Allen, 1999DermalKey, LD50 dermal > 2000 mg/kg bw (test item), Sanders, 2013Supporting, LD50 dermal: >2000 mg/kg bw (EC 234-392-1), Blanset, 1997Supporting, LD50 dermal: >2000 mg/kg bw (CAS 131459-39-7), Allen, 1999InhalationKey, LD50 inhalation: > 5100 mg/m3 air (aerosol) (CAS 68424-31-7), Parr-Dobrzanski, 1994 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22c24628-3ce0-461a-919b-bb6146e1af45/documents/IUC5-c9127e29-3d4d-434b-b050-326d78e54537_fdef6168-d35d-4cd9-aca0-44d01683aab9.html,,,,,, "2-ethyl-2-(((3,5,5-trimethylhexanoyl)oxy)methyl)propane-1,3-diyl bis(3,5,5-trimethylhexanoate)",65870-94-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22c24628-3ce0-461a-919b-bb6146e1af45/documents/IUC5-c9127e29-3d4d-434b-b050-326d78e54537_fdef6168-d35d-4cd9-aca0-44d01683aab9.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-ethyl-2-(((3,5,5-trimethylhexanoyl)oxy)methyl)propane-1,3-diyl bis(3,5,5-trimethylhexanoate)",65870-94-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22c24628-3ce0-461a-919b-bb6146e1af45/documents/IUC5-c9127e29-3d4d-434b-b050-326d78e54537_fdef6168-d35d-4cd9-aca0-44d01683aab9.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-ethyl-2-(((3,5,5-trimethylhexanoyl)oxy)methyl)propane-1,3-diyl bis(3,5,5-trimethylhexanoate)",65870-94-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22c24628-3ce0-461a-919b-bb6146e1af45/documents/IUC5-c9127e29-3d4d-434b-b050-326d78e54537_fdef6168-d35d-4cd9-aca0-44d01683aab9.html,,inhalation,discriminating conc.,"5,100 mg/m3",no adverse effect observed, "Reaction mass of (3R)- and (3S)-Isomers of 3,5,5-Trimethyl-hexanoic acid 2-[2,2,6,6-tetra-methyl-4-(3,5,5-trimethyl-hexanoyloxy)-piperidin-1-yl]-ethyl ester",1445870-18-7," Subacute toxicity was evaluated in a combined repeated dose toxicity / screening for reprotoxicity study according OECD 422 (GLP). Male and female rats were exposed orally to 15, 50 and 150 mg/kg bw/d. No adverse effects were observed. The NOAEL is 150 mg/kg bw/d. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd823132-aad9-4384-9088-cc36803e10bb/documents/c5756dc6-6bf4-4913-8284-de6f94e4d451_9b3a7e2b-50bb-461a-9c26-c133ac09447f.html,,,,,, "Reaction mass of (3R)- and (3S)-Isomers of 3,5,5-Trimethyl-hexanoic acid 2-[2,2,6,6-tetra-methyl-4-(3,5,5-trimethyl-hexanoyloxy)-piperidin-1-yl]-ethyl ester",1445870-18-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd823132-aad9-4384-9088-cc36803e10bb/documents/c5756dc6-6bf4-4913-8284-de6f94e4d451_9b3a7e2b-50bb-461a-9c26-c133ac09447f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Reaction mass of (3R)- and (3S)-Isomers of 3,5,5-Trimethyl-hexanoic acid 2-[2,2,6,6-tetra-methyl-4-(3,5,5-trimethyl-hexanoyloxy)-piperidin-1-yl]-ethyl ester",1445870-18-7, A single dose of the test item was administered orally or dermally to Wistar rats at concentrations of 2000 mg/kg bw. No mortality occurred. Clinical examiniation and gross necropsy did not reveal any findings. The LD50 after oral and dermal administration is therefore considered to be > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd823132-aad9-4384-9088-cc36803e10bb/documents/d4f57311-5243-4a5d-b1ef-808e5206def8_9b3a7e2b-50bb-461a-9c26-c133ac09447f.html,,,,,, "Reaction mass of (3R)- and (3S)-Isomers of 3,5,5-Trimethyl-hexanoic acid 2-[2,2,6,6-tetra-methyl-4-(3,5,5-trimethyl-hexanoyloxy)-piperidin-1-yl]-ethyl ester",1445870-18-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd823132-aad9-4384-9088-cc36803e10bb/documents/d4f57311-5243-4a5d-b1ef-808e5206def8_9b3a7e2b-50bb-461a-9c26-c133ac09447f.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Reaction mass of (3R)- and (3S)-Isomers of 3,5,5-Trimethyl-hexanoic acid 2-[2,2,6,6-tetra-methyl-4-(3,5,5-trimethyl-hexanoyloxy)-piperidin-1-yl]-ethyl ester",1445870-18-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd823132-aad9-4384-9088-cc36803e10bb/documents/d4f57311-5243-4a5d-b1ef-808e5206def8_9b3a7e2b-50bb-461a-9c26-c133ac09447f.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "tin(2+) bis(3,5,5-trimethylhexanoate)",1231728-34-9,"No data on repeated dose toxicity are available for hexanoic acid, 3,5,5-trimethyl-, tin (2+)salt (2:1). Data from an oral sub-acute toxicity study are available for the dissociation product 3,5,5-trimethylhexanoic acid, in addition data from an oral sub-chronic repeated dose toxicity study with tin chloride were evaluated. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d713062a-04df-4c94-b2ad-6eeab957ce0a/documents/IUC5-0aedb1c5-9726-420e-a9e2-3d9093449df6_a8bec4bd-0196-4b12-9ddf-140cb519fb11.html,,,,,, "tin(2+) bis(3,5,5-trimethylhexanoate)",1231728-34-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d713062a-04df-4c94-b2ad-6eeab957ce0a/documents/IUC5-0aedb1c5-9726-420e-a9e2-3d9093449df6_a8bec4bd-0196-4b12-9ddf-140cb519fb11.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,66 mg/kg bw/day,,rat "tin(2+) bis(3,5,5-trimethylhexanoate)",1231728-34-9,"The oral LD50 male/female in rats was determined to be > 300 - 2000 mg/kg bw in an acute oral toxicity study, Acute Toxic Class Method according to OECD guideline 423. The dermal LD50 male/female in rats was determined to be > 2000 mg/kg bw in an acute dermal toxicity study according to OECD guideline 402. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d713062a-04df-4c94-b2ad-6eeab957ce0a/documents/IUC5-16b2550a-dd7c-4b0c-8198-2284d02757ca_a8bec4bd-0196-4b12-9ddf-140cb519fb11.html,,,,,, "tin(2+) bis(3,5,5-trimethylhexanoate)",1231728-34-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d713062a-04df-4c94-b2ad-6eeab957ce0a/documents/IUC5-16b2550a-dd7c-4b0c-8198-2284d02757ca_a8bec4bd-0196-4b12-9ddf-140cb519fb11.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "tin(2+) bis(3,5,5-trimethylhexanoate)",1231728-34-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d713062a-04df-4c94-b2ad-6eeab957ce0a/documents/IUC5-16b2550a-dd7c-4b0c-8198-2284d02757ca_a8bec4bd-0196-4b12-9ddf-140cb519fb11.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "tris(2-hydroxyethyl)ammonium 6-(3,5,5-trimethylhexanamido)hexanoate",242482-67-3,"OECD 408 study (rat, 90d, oral): NOAEL = 500 mg/kg bw/day OECD 407 study (rat, 28d, oral): NOAEL = 500 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d14ad781-992f-43f9-9fb3-8a230a19d504/documents/IUC5-5fb18ce6-a6c1-4bc8-bbee-c39cc350c178_789453a4-090e-4fd1-a2bd-11fe0c62860a.html,,,,,, "tris(2-hydroxyethyl)ammonium 6-(3,5,5-trimethylhexanamido)hexanoate",242482-67-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d14ad781-992f-43f9-9fb3-8a230a19d504/documents/IUC5-5fb18ce6-a6c1-4bc8-bbee-c39cc350c178_789453a4-090e-4fd1-a2bd-11fe0c62860a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "tris(2-hydroxyethyl)ammonium 6-(3,5,5-trimethylhexanamido)hexanoate",242482-67-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d14ad781-992f-43f9-9fb3-8a230a19d504/documents/IUC5-5fb18ce6-a6c1-4bc8-bbee-c39cc350c178_789453a4-090e-4fd1-a2bd-11fe0c62860a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "tris(2-hydroxyethyl)ammonium 6-(3,5,5-trimethylhexanamido)hexanoate",242482-67-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is GLP compliant and has Klimisch score 1. Another reliable study (Klimisch 1 and GLP) performed with a surrogate of the submission substance supports the reported findings for the submission substance. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study is GLP compliant and has Klimisch score 1. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d14ad781-992f-43f9-9fb3-8a230a19d504/documents/IUC5-903399d8-03ea-43a4-8578-b41b621704f5_789453a4-090e-4fd1-a2bd-11fe0c62860a.html,,,,,, "tris(2-hydroxyethyl)ammonium 6-(3,5,5-trimethylhexanamido)hexanoate",242482-67-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d14ad781-992f-43f9-9fb3-8a230a19d504/documents/IUC5-903399d8-03ea-43a4-8578-b41b621704f5_789453a4-090e-4fd1-a2bd-11fe0c62860a.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "tris(2-hydroxyethyl)ammonium 6-(3,5,5-trimethylhexanamido)hexanoate",242482-67-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d14ad781-992f-43f9-9fb3-8a230a19d504/documents/IUC5-903399d8-03ea-43a4-8578-b41b621704f5_789453a4-090e-4fd1-a2bd-11fe0c62860a.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)",41098-56-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/728992d0-3b12-4a4e-a194-06676b776ab5/documents/bdd7b0ac-ad79-4352-a890-98ed6871fc8c_521e56d6-842c-4c4d-8a80-12c2e10cb132.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)",41098-56-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/728992d0-3b12-4a4e-a194-06676b776ab5/documents/IUC5-cc651c42-cd6c-404a-8e04-86093677b01d_521e56d6-842c-4c4d-8a80-12c2e10cb132.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)",41098-56-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/728992d0-3b12-4a4e-a194-06676b776ab5/documents/IUC5-cc651c42-cd6c-404a-8e04-86093677b01d_521e56d6-842c-4c4d-8a80-12c2e10cb132.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-(diethylamino)-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)",41098-56-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/728992d0-3b12-4a4e-a194-06676b776ab5/documents/IUC5-cc651c42-cd6c-404a-8e04-86093677b01d_521e56d6-842c-4c4d-8a80-12c2e10cb132.html,,inhalation,LC50,"1,895 mg/m3",no adverse effect observed, "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-[(2-cyanoethyl)[2-(2-hydroxyethoxy)ethyl]amino]-1,3,5-triazine-4,2-diyl]imino]]bis[benzene-1,4-disulphonate]",79135-87-8, Oral NOAEL (28d) (male and female): 200 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce20a72c-82e0-488a-a114-fcf4666af069/documents/a22e7c59-45c2-41a2-823a-35372273c6d9_4d80d63b-47dd-4a8a-8e12-00b39487c18e.html,,,,,, "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-[(2-cyanoethyl)[2-(2-hydroxyethoxy)ethyl]amino]-1,3,5-triazine-4,2-diyl]imino]]bis[benzene-1,4-disulphonate]",79135-87-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce20a72c-82e0-488a-a114-fcf4666af069/documents/a22e7c59-45c2-41a2-823a-35372273c6d9_4d80d63b-47dd-4a8a-8e12-00b39487c18e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-[(2-cyanoethyl)[2-(2-hydroxyethoxy)ethyl]amino]-1,3,5-triazine-4,2-diyl]imino]]bis[benzene-1,4-disulphonate]",79135-87-8, Not harmful/toxic if swallowed Not harmful/toxic by dermal contact ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce20a72c-82e0-488a-a114-fcf4666af069/documents/5d798c23-3a5b-4cdb-a48d-825786fe73d2_4d80d63b-47dd-4a8a-8e12-00b39487c18e.html,,,,,, "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)",68971-49-3, NOAEL in male and female rats = 80 mg/kg bw/day (based on the OECD 422 study on OB 3a-DSA) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b6f8e7b-7ea9-440f-ac48-02fce90ba733/documents/20c32fb4-e8d1-4174-8c8d-fd392ea2e671_90be75f6-70f3-4725-b8dd-80f26138b9ce.html,,,,,, "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)",68971-49-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b6f8e7b-7ea9-440f-ac48-02fce90ba733/documents/20c32fb4-e8d1-4174-8c8d-fd392ea2e671_90be75f6-70f3-4725-b8dd-80f26138b9ce.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)",68971-49-3, Rat oral LD50 > 5000 mg/kg bw Rat inhalation LC50 > 1895 mg/m3 Rat dermal LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b6f8e7b-7ea9-440f-ac48-02fce90ba733/documents/IUC5-72ed3baa-0ff2-4e35-87ef-acec3f6822d3_90be75f6-70f3-4725-b8dd-80f26138b9ce.html,,,,,, "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)",68971-49-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b6f8e7b-7ea9-440f-ac48-02fce90ba733/documents/IUC5-72ed3baa-0ff2-4e35-87ef-acec3f6822d3_90be75f6-70f3-4725-b8dd-80f26138b9ce.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)",68971-49-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b6f8e7b-7ea9-440f-ac48-02fce90ba733/documents/IUC5-72ed3baa-0ff2-4e35-87ef-acec3f6822d3_90be75f6-70f3-4725-b8dd-80f26138b9ce.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-[bis(2-hydroxyethyl)amino]-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)",68971-49-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b6f8e7b-7ea9-440f-ac48-02fce90ba733/documents/IUC5-72ed3baa-0ff2-4e35-87ef-acec3f6822d3_90be75f6-70f3-4725-b8dd-80f26138b9ce.html,,inhalation,LC50,"1,895 mg/m3",no adverse effect observed, "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)",52301-70-9, NOAEL in male and female rats = 80 mg/kg bw/day (based on the OECD 422 study on OB 3a-DSA) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0507a0a-3558-45fa-8faf-4d2152039e27/documents/a4c6151d-c265-428b-a372-b1fd409cc660_37e71435-5bbf-451e-a2a9-fd853efb4935.html,,,,,, "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)",52301-70-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0507a0a-3558-45fa-8faf-4d2152039e27/documents/a4c6151d-c265-428b-a372-b1fd409cc660_37e71435-5bbf-451e-a2a9-fd853efb4935.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)",52301-70-9," The oral LD50 of the substance was found to be greater than 5000 mg/kg bw, while the dermal LD50 was >2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0507a0a-3558-45fa-8faf-4d2152039e27/documents/917a4aba-47be-4f88-b6c5-8e92e15b3749_37e71435-5bbf-451e-a2a9-fd853efb4935.html,,,,,, "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)",52301-70-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0507a0a-3558-45fa-8faf-4d2152039e27/documents/917a4aba-47be-4f88-b6c5-8e92e15b3749_37e71435-5bbf-451e-a2a9-fd853efb4935.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)",52301-70-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0507a0a-3558-45fa-8faf-4d2152039e27/documents/917a4aba-47be-4f88-b6c5-8e92e15b3749_37e71435-5bbf-451e-a2a9-fd853efb4935.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hexasodium 4,4'-[1,4-phenylenebis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]bis[5-hydroxy-6-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate]",68214-04-0," In a test according to OECD 422 the substance was administered daily by oral gavage to 12 male and female adult rats in three groups at dosages of 500 mg (1000 mg during study days 1-28), 250 mg and 62,5 mg test item per kg body weight over a period of at least 28 days (males) and at least 49 days (females). Male and female animals were mated within their treatment group during the treatment period. Litters were used for evaluation of developmental and reproduction related parameters but did not receive test item treatment. Further 24 animals (12 males and 12 females) received the vehicle solution as control; all other parameters were identical. Clinical signs and viability were monitored daily during the in-life phase. Individual body weight was recorded once weekly. Individual food / water consumption of female animals and group food / water consumption of male animals were recorded once weekly. Detailed clinical signs were monitored weekly from all adult animals. Grip strength and reactivity to stimuli (beam-walking test) was assessed from 5 randomly selected adult animals per sex and group during the last exposure week. At the end of the treatment period, blood samples were taken from all adult animals to provide T4-hormone data. For assessment of additional toxicological parameters, 5 adult animals per sex and group were randomly selected for additional blood sampling (females during end of pre-mating, males at day of necropsy) to provide data on hematology and clinical biochemistry. All adult and offspring animals were sacrificed after bleeding and examined by gross necropsy. Weights of selected organs were recorded and selected tissues and organs were preserved with special emphasis on organs of the reproductive system. From 5 randomly selected adult animals per sex and group, additional organs were preserved and examined microscopically. Three animals (two of the high dose groups and one of the medium dose group) were found dead during premating or first mating phase. Animals died soon after dosing. Therefore, a gavage-related reflux and, as a consequence, regurgitation and aspiration of test item into trachea and lung are assumed as cause of death. Two animals of the high dose groups were found dead and two animals of the medium dose groups were sacrificed due to technical gavage errors. Animal behavioral signs of salivation after dose application were observed in the test item-treated male and female animal groups, but the findings were predominantly observed at the high dose. Regarding the body weight and the body weight gain, no significant differences were observed between all substance-treated animal groups (male and female) and their respective vehicle control groups. The monitoring of food consumption revealed no test item-related difference between all female and male experimental dose groups and the respective vehicle control groups. The monitoring of water consumption revealed a dose dependent increased water consumption in males, when compared to vehicle animals. The T4-hormone analysis in blood plasma from experimental animal groups did not reveal a substance-related significant difference in absolute T4-hormone content between test groups and respective control groups. No adverse effects of the test item were observed in hematology and clinical biochemistry of selected animals from all test item-treated groups. Effects seen were within historical control ranges. The necropsy of males and females did not reveal any findings, which could be regarded as adverse or toxicological relevant for animal reproduction or development. None of the findings could be associated with the administration of the test item. Male dose groups showed higher liver weights than control animals. This finding was considered substance related but toxicological irrelevant. There were no macroscopic observations attributed to the substance. There were no substance-related microscopic observations in male and female reproductive organs. Substance-related microscopic observations were only found in the kidney and were characterized by minimal to moderate mononuclear inflammatory cell infiltrates in the renal interstitium. Daily administration of the substance resulted in some minor animal behavioral changes observed in male and female animals predominately of the high dose groups, alterations in water consumption in male dose groups, changes in clinical biochemistry (AP lower and K higher) in the female high dose group and microscopic changes in the kidneys of male and female high dose animals. The findings were not considered adverse. As the findings could not be associated with a substantial impact on the animal’s health, the NOAEL regarding the repeated dose toxicity was set to 250 mg/kg body weight.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5fbbe570-9378-4da5-b746-c9f0e2680739/documents/492aa035-3424-472a-a5e1-a19a6966cbf2_22322422-7a4e-4271-9fca-bab198d01b67.html,,,,,, "Hexasodium 4,4'-[1,4-phenylenebis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]bis[5-hydroxy-6-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate]",68214-04-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5fbbe570-9378-4da5-b746-c9f0e2680739/documents/492aa035-3424-472a-a5e1-a19a6966cbf2_22322422-7a4e-4271-9fca-bab198d01b67.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Hexasodium 4,4'-[1,4-phenylenebis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]bis[5-hydroxy-6-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate]",68214-04-0," Five rats/sex received a single oral dose of the substance at 4175 mg/kg bw (vehicle water). No effects on mortality and clinical signs were reported during the 14 day observation period. Necropsy showed reddish discoloration of the kidney. The LD50 is > 4175 mg/kg bw (Ciba 1974). This finding of very low toxicity is confirmed in two additional studies, both indicative for a LD50 of > 5000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fbbe570-9378-4da5-b746-c9f0e2680739/documents/19a65a63-3e98-4ab5-9ea5-7d84acaef641_22322422-7a4e-4271-9fca-bab198d01b67.html,,,,,, "Hexasodium 4,4'-[1,4-phenylenebis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino]]bis[5-hydroxy-6-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate]",68214-04-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fbbe570-9378-4da5-b746-c9f0e2680739/documents/19a65a63-3e98-4ab5-9ea5-7d84acaef641_22322422-7a4e-4271-9fca-bab198d01b67.html,,oral,LD50,"4,175 mg/kg bw",no adverse effect observed, "Hexasodium 4,4'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate]",17791-81-0,The no observed adverse effect level (NOAEL) for general systemic toxicity was 60 mg/kg bw/d (definitive dose: 52.8 mg/kg bw/d) for male and at least 300 mg/kg bw/d (definitve dose: 264.0 mg/kg bw/d) for female Wistar rats. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64015a4e-4c0c-4b44-bc17-03e5e3238023/documents/IUC5-07b0e50c-5255-4c8e-8c49-d86f39d3a369_f7fb3004-c41b-48e8-ab55-cd8b4b1fe0fb.html,,,,,, "Hexasodium 4,4'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate]",17791-81-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64015a4e-4c0c-4b44-bc17-03e5e3238023/documents/IUC5-07b0e50c-5255-4c8e-8c49-d86f39d3a369_f7fb3004-c41b-48e8-ab55-cd8b4b1fe0fb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat "Hexasodium 4,4'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate]",17791-81-0," oral acute toxicity: LD50 value > 2000 mg/kg bw for the pure substance (extrapolation based on results with mixture) dermal acute toxicity: LD50 value > 2000 mg/kg bw for the pure substance (extrapolation based on results with mixture). Read across was done to hexasodium 2,2'-{ethene-1,2-diylbis[(3-sulfonato-4,1-phenylene)imino(6-morpholin-4-yl-1,3,5-triazine-4,2-diyl)imino]}dibenzene-1,4-disulfonate, CAS 52301-70-9 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64015a4e-4c0c-4b44-bc17-03e5e3238023/documents/IUC5-26e8e1f6-8dc2-46cd-8bcc-a71fd1817222_f7fb3004-c41b-48e8-ab55-cd8b4b1fe0fb.html,,,,,, "Hexasodium 4,4'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate]",17791-81-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64015a4e-4c0c-4b44-bc17-03e5e3238023/documents/IUC5-26e8e1f6-8dc2-46cd-8bcc-a71fd1817222_f7fb3004-c41b-48e8-ab55-cd8b4b1fe0fb.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Hexasodium 4,4'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis[5-hydroxy-6-(phenylazo)naphthalene-2,7-disulphonate]",17791-81-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64015a4e-4c0c-4b44-bc17-03e5e3238023/documents/IUC5-26e8e1f6-8dc2-46cd-8bcc-a71fd1817222_f7fb3004-c41b-48e8-ab55-cd8b4b1fe0fb.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Hexasodium 4-amino-3,6-bis[[5-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl]azo]-5-hydroxynaphthalene-2,7-disulphonate",68133-24-4," Five rats/sex received a single oral dose of the similar substance 1 at 4175 mg/kg bw (vehicle water). No effects on mortality and clinical signs were reported during the 14 day observation period. Necropsy showed reddish discoloration of the kidney. The LD50 is > 4175 mg/kg bw (Ciba 1974). This finding of very low toxicity is confirmed in two additional studies, both indicative for a LD50 of > 5000 mg/kg bw. Moreover a prediction with the QSAR dyes RC 2.0 Developed by Milano Chemometrics and QASR research group Dept. Earth and Environmental Science, University Milano was performed on Reactive Blue 171, and the substance resulted not classified. Read across is discussed in section 13. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4944a06-5d29-47c7-9b31-46467a1203a4/documents/0242b9ee-96e3-4b7a-8dc9-4d8617739c0d_5d143234-c4de-439b-8f72-1e1fa23801f1.html,,,,,, "Hexasodium 4-amino-3,6-bis[[5-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl]azo]-5-hydroxynaphthalene-2,7-disulphonate",68133-24-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4944a06-5d29-47c7-9b31-46467a1203a4/documents/0242b9ee-96e3-4b7a-8dc9-4d8617739c0d_5d143234-c4de-439b-8f72-1e1fa23801f1.html,,oral,LD50,"4,175 mg/kg bw",no adverse effect observed, "Hexasodium 6,13-dichloro-3,10-bis[[2-[[4-chloro-6-[(2,4-disulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]triphenodioxazine-4,11-disulphonate",84434-51-5,"Reactive Blue 198 is practically non-toxic. The LD50 for oral administration is > 2000 mg/kg body weight, the LD50 for dermal application with the structural analogue 01 lies above 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93bf860a-052a-4900-ab13-8e969017f8b4/documents/IUC5-8915b9f6-8b11-4309-9baa-ed270d3d81b9_f0cd5b52-68ac-4cf3-883c-3de0cd039fbe.html,,,,,, "Hexasodium 6,13-dichloro-3,10-bis[[2-[[4-chloro-6-[(2,4-disulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]triphenodioxazine-4,11-disulphonate",84434-51-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93bf860a-052a-4900-ab13-8e969017f8b4/documents/IUC5-8915b9f6-8b11-4309-9baa-ed270d3d81b9_f0cd5b52-68ac-4cf3-883c-3de0cd039fbe.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hexasodium 6,13-dichloro-3,10-bis[[2-[[4-chloro-6-[(2,4-disulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]ethyl]amino]triphenodioxazine-4,11-disulphonate",84434-51-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93bf860a-052a-4900-ab13-8e969017f8b4/documents/IUC5-8915b9f6-8b11-4309-9baa-ed270d3d81b9_f0cd5b52-68ac-4cf3-883c-3de0cd039fbe.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Hexene,25264-93-1," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c0d89b1-6555-4f28-8153-1d6827e04384/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_8db87136-38da-4de0-88b3-5ed23c72d8c3.html,,,,,, Hexene,25264-93-1,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c0d89b1-6555-4f28-8153-1d6827e04384/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_8db87136-38da-4de0-88b3-5ed23c72d8c3.html,,,,,, Hexyl acrylate,2499-95-8," Oral NOAEL 84 mg/kg (male), 111 mg/kg (female) for Rat; equivalent or similar to OECD 408 (Read-Across to n-butyl acrylate) Inhalation-systemic NOAEC 570 mg/m3 (male/female) for Rat; equiavlent or similar to OECD TG 413 (Read-Across to n-butyl acrylate) Inhalation- local LOAEC 86 mg/m3 (male/female); systemic NOAEC 258 mg/m3 (male/female) for Rat; equivalent or similar to OECD TG 453 (Read-Across to n-butyl acrylate) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f624def-a3ec-45e7-bea1-c1162ce36d1c/documents/e9b90a9c-39ff-4ef2-8aca-51aec2afefb3_10ecfb7b-5810-412f-99c9-e8671f8c0adc.html,,,,,, Hexyl acrylate,2499-95-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f624def-a3ec-45e7-bea1-c1162ce36d1c/documents/e9b90a9c-39ff-4ef2-8aca-51aec2afefb3_10ecfb7b-5810-412f-99c9-e8671f8c0adc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,84 mg/kg bw/day,,rat Hexyl acrylate,2499-95-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f624def-a3ec-45e7-bea1-c1162ce36d1c/documents/e9b90a9c-39ff-4ef2-8aca-51aec2afefb3_10ecfb7b-5810-412f-99c9-e8671f8c0adc.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,570 mg/m3,,rat Hexyl acrylate,2499-95-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f624def-a3ec-45e7-bea1-c1162ce36d1c/documents/e9b90a9c-39ff-4ef2-8aca-51aec2afefb3_10ecfb7b-5810-412f-99c9-e8671f8c0adc.html,Repeated dose toxicity – local effects,inhalation,LOAEC,86 mg/m3,adverse effect observed,rat Hexyl acrylate,2499-95-8, Acute Toxicity- Oral LD50 = 22930 mg/kg in rats Acute Toxicity- Dermal LD50 = 4983 mg/kg in rabbits ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f624def-a3ec-45e7-bea1-c1162ce36d1c/documents/10eaa219-d740-4827-9c8a-2df03aa5f241_10ecfb7b-5810-412f-99c9-e8671f8c0adc.html,,,,,, Hexyl acrylate,2499-95-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f624def-a3ec-45e7-bea1-c1162ce36d1c/documents/10eaa219-d740-4827-9c8a-2df03aa5f241_10ecfb7b-5810-412f-99c9-e8671f8c0adc.html,,oral,LD50,"22,930 mg/kg bw",no adverse effect observed, Hexyl acrylate,2499-95-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f624def-a3ec-45e7-bea1-c1162ce36d1c/documents/10eaa219-d740-4827-9c8a-2df03aa5f241_10ecfb7b-5810-412f-99c9-e8671f8c0adc.html,,dermal,LD50,"4,983 mg/kg bw",no adverse effect observed, Hexyl chloroformate,6092-54-2,"The LC50 for male and female rats after vapor inhalation, determined in a study compliant to OECD guideline 403 and GLP, was estimated to be 1.17 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d6a890d-b5df-4e5a-acb9-208d7a8f0918/documents/IUC5-b22c1b1f-6f26-4bb5-b27c-857c76e8f4d7_9e3a575f-7df9-49b5-8689-6a038fdc5a23.html,,,,,, Hexyl D-glucoside,54549-24-5,An oral subchronic repeated dose toxicity study revealed a NOAEL of 1000 mg/kg/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3568ba95-8f63-4774-b21b-bcfca96862dd/documents/IUC5-4cee12c0-6b87-4e00-900d-a2caeeb7304a_b63f23ca-0ea9-419c-9e52-faad37418763.html,,,,,, Hexyl D-glucoside,54549-24-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3568ba95-8f63-4774-b21b-bcfca96862dd/documents/IUC5-4cee12c0-6b87-4e00-900d-a2caeeb7304a_b63f23ca-0ea9-419c-9e52-faad37418763.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, Hexyl D-glucoside,54549-24-5,"Many high quality studies investigating the acute toxicity of APG have shown that in terms of acute toxicity the use of these compounds are of low concern. They are of low oral, dermal and inhalation toxicity. From a structural activity point of view, the length of the alkyl chain did not exert any meaningful influence on acute toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3568ba95-8f63-4774-b21b-bcfca96862dd/documents/IUC5-1557fc29-cb3b-42d4-8881-9d0c7d41a90f_b63f23ca-0ea9-419c-9e52-faad37418763.html,,,,,, Hexyl D-glucoside,54549-24-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3568ba95-8f63-4774-b21b-bcfca96862dd/documents/IUC5-1557fc29-cb3b-42d4-8881-9d0c7d41a90f_b63f23ca-0ea9-419c-9e52-faad37418763.html,,oral,LD50,"2,000 mg/kg bw",, Hexyl D-glucoside,54549-24-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3568ba95-8f63-4774-b21b-bcfca96862dd/documents/IUC5-1557fc29-cb3b-42d4-8881-9d0c7d41a90f_b63f23ca-0ea9-419c-9e52-faad37418763.html,,dermal,LD50,"2,000 mg/kg bw",, Hexylamine,111-26-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The K2 data predicted us the QECD QSAR toolbox version 3.3 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The K2 data predicted us the QECD QSAR toolbox version 3.3 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/222ea956-ad74-46cc-8b02-0be20b238efe/documents/b50d4115-4ac1-4646-a3be-505db104fece_630f70f8-c861-45ce-a167-1853d40af08b.html,,,,,, Hexylamine,111-26-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/222ea956-ad74-46cc-8b02-0be20b238efe/documents/b50d4115-4ac1-4646-a3be-505db104fece_630f70f8-c861-45ce-a167-1853d40af08b.html,,oral,LD50,422.7 mg/kg bw,adverse effect observed, Hexylamine,111-26-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/222ea956-ad74-46cc-8b02-0be20b238efe/documents/b50d4115-4ac1-4646-a3be-505db104fece_630f70f8-c861-45ce-a167-1853d40af08b.html,,dermal,LD50,470.93 mg/kg bw,adverse effect observed, "Hop, Humulus lupulus, ext., isomerized, potassium salt",94349-84-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3306359b-c529-4c0a-8656-35efda5c1f17/documents/33058de7-2764-43d0-a2d1-0b1da17a7224_1a1c0a07-caf9-4b86-9125-d7a40e0f7920.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Hop, Humulus lupulus, ext., isomerized, potassium salt",94349-84-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3306359b-c529-4c0a-8656-35efda5c1f17/documents/a3aba3f0-60cf-4169-bb02-e4c6cd1d4eae_1a1c0a07-caf9-4b86-9125-d7a40e0f7920.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, "Hop, Humulus lupulus, ext., isomerized, potassium salt",94349-84-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3306359b-c529-4c0a-8656-35efda5c1f17/documents/a3aba3f0-60cf-4169-bb02-e4c6cd1d4eae_1a1c0a07-caf9-4b86-9125-d7a40e0f7920.html,,dermal,LD50,"1,000 mg/kg bw",, "Humic acids, potassium salts",68514-28-3,"EU Method B.7. Repeated Dose (28-days) Toxicity (Oral), Directive 96/54/EC, published in OJ L 248, 1996. GLP study EU Method B.26 Sub-Chronic Oral Toxicity Test: Repeated Dose 90-Day Oral Toxicity Study in Rodents, Council Regulation (EC) No. 440/2008, Published in O.J. L142, 2008.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcb35ffd-bcd0-49f9-9881-854d876dc279/documents/IUC5-9ce16071-17f1-4c9a-a345-bd80e2b7d432_abcae904-4ad4-41b1-a763-743c425788c1.html,,,,,, "Humic acids, potassium salts",68514-28-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcb35ffd-bcd0-49f9-9881-854d876dc279/documents/IUC5-9ce16071-17f1-4c9a-a345-bd80e2b7d432_abcae904-4ad4-41b1-a763-743c425788c1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Humic acids, potassium salts",68514-28-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcb35ffd-bcd0-49f9-9881-854d876dc279/documents/IUC5-9ce16071-17f1-4c9a-a345-bd80e2b7d432_abcae904-4ad4-41b1-a763-743c425788c1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Humic acids, potassium salts",68514-28-3,"The tests of Acute oral toxicity and Acute dermal toxicity were performed according to the following methods: Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Directive 2004/73/EC, published in O.J. L152, 2004.Method B.3 Acute Toxicity (Dermal), Directive 92/69/EEC, published in OJ L 383A, 1992.Both: GLP study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcb35ffd-bcd0-49f9-9881-854d876dc279/documents/IUC5-c6b2106e-1d8b-4474-a589-c4de4bd5ce64_abcae904-4ad4-41b1-a763-743c425788c1.html,,,,,, "Humic acids, potassium salts",68514-28-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcb35ffd-bcd0-49f9-9881-854d876dc279/documents/IUC5-c6b2106e-1d8b-4474-a589-c4de4bd5ce64_abcae904-4ad4-41b1-a763-743c425788c1.html,,oral,LD50,"2,000 mg/kg bw",, "Humic acids, potassium salts",68514-28-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcb35ffd-bcd0-49f9-9881-854d876dc279/documents/IUC5-c6b2106e-1d8b-4474-a589-c4de4bd5ce64_abcae904-4ad4-41b1-a763-743c425788c1.html,,dermal,LD50,"2,000 mg/kg bw",, "Hydrazinecarboximidamide, 2-[(2-hydroxyphenyl)methylene]-, reaction products with 2-undecanone",68411-85-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8f5a77b-40cc-42d1-a898-fe3bf1c5bbc8/documents/59cbce01-2857-47a0-b272-d095d509b69c_c2558fdf-c036-44ca-9605-8cf694389dc2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrazinecarboximidamide, 2-[(2-hydroxyphenyl)methylene]-, reaction products with 2-undecanone",68411-85-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8f5a77b-40cc-42d1-a898-fe3bf1c5bbc8/documents/59cbce01-2857-47a0-b272-d095d509b69c_c2558fdf-c036-44ca-9605-8cf694389dc2.html,,dermal,LD50,"10,000 mg/kg bw",no adverse effect observed, "Hydrocarbon waxes (petroleum), clay-treated microcryst.",64742-42-3,"Paraffin and hydrocarbon waxes were found to be of low acute toxicity by the oral, and dermal routes.  There are no reports of acute inhalation toxicity studies of paraffin and hydrocarbon waxes; however, due to the very low vapour pressures of these substances, exposure by inhalation is not expected. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/202f2a96-12d2-4ec9-9a40-5a627d149854/documents/f15719c3-410b-4c16-9d58-061adb431c23_1ea2b759-b33f-4ad1-9924-bef5654e20fe.html,,,,,, "Hydrocarbon waxes (petroleum), clay-treated microcryst.",64742-42-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/202f2a96-12d2-4ec9-9a40-5a627d149854/documents/f15719c3-410b-4c16-9d58-061adb431c23_1ea2b759-b33f-4ad1-9924-bef5654e20fe.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rat "Hydrocarbon waxes (petroleum), clay-treated microcryst.",64742-42-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/202f2a96-12d2-4ec9-9a40-5a627d149854/documents/f15719c3-410b-4c16-9d58-061adb431c23_1ea2b759-b33f-4ad1-9924-bef5654e20fe.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,500 mg/kg bw/day",,rat "Hydrocarbon waxes (petroleum), clay-treated microcryst.",64742-42-3,The acute toxicity of paraffin and hydrocarbon waxes is low with no observed mortalities from oral (OECD 401/420) or dermal (OECD 402) applications. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/202f2a96-12d2-4ec9-9a40-5a627d149854/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_1ea2b759-b33f-4ad1-9924-bef5654e20fe.html,,,,,, "Hydrocarbon waxes (petroleum), clay-treated microcryst.",64742-42-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/202f2a96-12d2-4ec9-9a40-5a627d149854/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_1ea2b759-b33f-4ad1-9924-bef5654e20fe.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrocarbon waxes (petroleum), clay-treated microcryst.",64742-42-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/202f2a96-12d2-4ec9-9a40-5a627d149854/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_1ea2b759-b33f-4ad1-9924-bef5654e20fe.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbon waxes (petroleum), oxidized",64743-00-6,"ORALNOAEL = 1000 mg/kg/day, 54 days rat male/female, OECD 422, Dhinsa 2005INHALATIONIn accordance with Column 1 of Annex VIII of Regulation (EC) 1907/2006 (REACH), the repeated dose toxicity study required under information point 8.6. should be conducted using the most appropriate route of administration. It is considered justified to omit the repeated dose inhalation toxicity study on the basis of exposure considerations. DERMALIn accordance with Column 1 of Annex VIII of Regulation (EC) 1907/2006 (REACH), the repeated dose toxicity study required under information point 8.6. should be conducted using the most appropriate route of administration. It is considered justified to omit the repeated dose dermal toxicity study on the basis of exposure considerations.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f23cfa03-e727-4809-a086-6e147fd357c0/documents/837eb615-f05a-4274-83b0-1bec0b1cd6c4_c6fa7c76-fdc3-40d2-addc-66797d4fce0b.html,,,,,, "Hydrocarbon waxes (petroleum), oxidized",64743-00-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f23cfa03-e727-4809-a086-6e147fd357c0/documents/837eb615-f05a-4274-83b0-1bec0b1cd6c4_c6fa7c76-fdc3-40d2-addc-66797d4fce0b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hydrocarbon waxes (petroleum), oxidized",64743-00-6,"ACUTE ORAL TOXICITYThe acute oral toxicity of hydrocarbon waxes was determined to be LD50 > 5000 mg/l according to a GLP compliant study (Gabriel, 1993) performed according to the standardised guideline 40 CFR Part 798, EPA Health Effects Testing Guidelines - Subpart B - General Toxicity Testing.ACUTE INHALATION TOXCITYIn accordance with Column 2 (adaptation statement) of Annex VIII of Regulation (EC) 1907/2006 (REACH), the acute dermal toxicity study required under information point 8.5.2 does not need to be conducted as the nature of the substance means that it is not potentially inhalable.ACUTE DERMAL TOXICITYIn accordance with Section 1 of Annex XI of Regulation (EC) 1907/2006 (REACH), the acute dermal toxicity study required under information point 8.5.3 of Annex VII does not need to be conducted as it is scientifically unjustified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f23cfa03-e727-4809-a086-6e147fd357c0/documents/1d43bdc9-b18e-48a0-a590-07c1fc3823b7_c6fa7c76-fdc3-40d2-addc-66797d4fce0b.html,,,,,, "Hydrocarbon waxes (petroleum), oxidized",64743-00-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f23cfa03-e727-4809-a086-6e147fd357c0/documents/1d43bdc9-b18e-48a0-a590-07c1fc3823b7_c6fa7c76-fdc3-40d2-addc-66797d4fce0b.html,,oral,,"5,000 mg/kg bw",no adverse effect observed, "Hydrocarbon waxes (petroleum), oxidized, calcium salts",68603-09-8,"ORALNOAEL = 1000 mg/kg/day, 54 days rat male/female, OECD 422, Dhinsa 2005INHALATIONIn accordance with Column 1 of Annex VIII of Regulation (EC) 1907/2006 (REACH), the repeated dose toxicity study required under information point 8.6. should be conducted using the most appropriate route of administration. It is considered justified to omit the repeated dose inhalation toxicity study on the basis of exposure considerations. DERMALIn accordance with Column 1 of Annex VIII of Regulation (EC) 1907/2006 (REACH), the repeated dose toxicity study required under information point 8.6. should be conducted using the most appropriate route of administration. It is considered justified to omit the repeated dose dermal toxicity study on the basis of exposure considerations.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29d61b81-9177-49e3-bac1-559135727940/documents/IUC5-a7972bca-06c9-4001-a523-4e116534f5d1_f111418d-19e1-4b0f-a5a5-63fafc12c1f1.html,,,,,, "Hydrocarbon waxes (petroleum), oxidized, calcium salts",68603-09-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29d61b81-9177-49e3-bac1-559135727940/documents/IUC5-a7972bca-06c9-4001-a523-4e116534f5d1_f111418d-19e1-4b0f-a5a5-63fafc12c1f1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hydrocarbon waxes (petroleum), oxidized, calcium salts",68603-09-8,"ORALLD50 = > 15 mL/kg bw, male/female rat, Anonymous 1980INHALATIONIn accordance with Column 2 (adaptation statement) of Annex VIII of Regulation (EC) 1907/2006 (REACH), it is considered justified to omit the acute inhalation toxicity study required under information point 8.5.2 on the basis of exposure considerations. The nature of the registered substance means that it is not potentially inhalable.DERMALIn accordance with Section 1 of Annex XI of Regulation (EC) 1907/2006 (REACH), it is considered justified to omit the acute dermal toxicity study required under information point 8.5.3 of Annex VII on the basis of exposure considerations; no dermal absorption of the registered substance is expected to occur. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29d61b81-9177-49e3-bac1-559135727940/documents/IUC5-542451c6-92f2-462c-b64f-da68b8806199_f111418d-19e1-4b0f-a5a5-63fafc12c1f1.html,,,,,, "Hydrocarbon waxes (petroleum), oxidized, Me esters",68602-85-7," Oral route: No Observed Adverse Effect Level (NOAEL) was considered to be1000 mg/kg bw/day (OECD 407, EU Method B.7, OPPTS 870.3050 and relevant Japanese guidelines). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac900b3a-df96-4497-9047-47b948e4409f/documents/b1a85072-a641-484b-8837-1186c6a6c3fd_6c2db69d-708c-4ce5-8790-cfe752f8b088.html,,,,,, "Hydrocarbon waxes (petroleum), oxidized, Me esters",68602-85-7, The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was found to be > 2000 mg/kg bw using the fixed dose method (OECD 420 and EU Method B.1 bis). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac900b3a-df96-4497-9047-47b948e4409f/documents/baea82d8-fc13-45ad-bb0c-6d39075db597_6c2db69d-708c-4ce5-8790-cfe752f8b088.html,,,,,, "Hydrocarbon waxes (petroleum), oxidized, Me esters, barium salts",68603-10-1,"ORALNOAEL = 1000 mg/kg/day, 54 days rat male/female, OECD 422, Dhinsa 2005INHALATIONIn accordance with Column 1 of Annex VIII of Regulation (EC) 1907/2006 (REACH), the repeated dose toxicity study required under information point 8.6. should be conducted using the most appropriate route of administration. It is considered justified to omit the repeated dose inhalation toxicity study on the basis of exposure considerations. DERMALIn accordance with Column 1 of Annex VIII of Regulation (EC) 1907/2006 (REACH), the repeated dose toxicity study required under information point 8.6. should be conducted using the most appropriate route of administration. It is considered justified to omit the repeated dose dermal toxicity study on the basis of exposure considerations.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf30e442-2a1a-479d-a675-e28416119625/documents/IUC5-91342454-8892-4311-89b5-398d38e162ff_5a706ae0-d836-4a76-bf18-c7d418e36c79.html,,,,,, "Hydrocarbon waxes (petroleum), oxidized, Me esters, barium salts",68603-10-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf30e442-2a1a-479d-a675-e28416119625/documents/IUC5-91342454-8892-4311-89b5-398d38e162ff_5a706ae0-d836-4a76-bf18-c7d418e36c79.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hydrocarbon waxes (petroleum), oxidized, Me esters, barium salts",68603-10-1,"ORALLD50 = > 15 mL/kg bw, male/female rat, Anonymous 1980INHALATIONIn accordance with Column 2 (adaptation statement) of Annex VIII of Regulation (EC) 1907/2006 (REACH), it is considered justified to omit the acute inhalation toxicity study required under information point 8.5.2 on the basis of exposure considerations. The nature of the registered substance means that it is not potentially inhalable.DERMALIn accordance with Section 1 of Annex XI of Regulation (EC) 1907/2006 (REACH), it is considered justified to omit the acute dermal toxicity study required under information point 8.5.3 of Annex VII on the basis of exposure considerations; no dermal absorption of the registered substance is expected to occur. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf30e442-2a1a-479d-a675-e28416119625/documents/IUC5-0ea1e418-e616-491f-9694-40c31c973142_5a706ae0-d836-4a76-bf18-c7d418e36c79.html,,,,,, "Hydrocarbon waxes (petroleum), oxidized, Me esters, calcium salts",68603-11-2,"ORALNOAEL = 1000 mg/kg/day, 54 days rat male/female, OECD 422, Dhinsa 2005INHALATIONIn accordance with Column 1 of Annex VIII of Regulation (EC) 1907/2006 (REACH), the repeated dose toxicity study required under information point 8.6. should be conducted using the most appropriate route of administration. It is considered justified to omit the repeated dose inhalation toxicity study on the basis of exposure considerations. DERMALIn accordance with Column 1 of Annex VIII of Regulation (EC) 1907/2006 (REACH), the repeated dose toxicity study required under information point 8.6. should be conducted using the most appropriate route of administration. It is considered justified to omit the repeated dose dermal toxicity study on the basis of exposure considerations.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/797971ce-9c57-492d-87b1-8891ac459c38/documents/IUC5-23f55fff-288e-4833-b8d9-b75b05dfc3a7_907d993d-a546-493c-a63d-5046714eb704.html,,,,,, "Hydrocarbon waxes (petroleum), oxidized, Me esters, calcium salts",68603-11-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/797971ce-9c57-492d-87b1-8891ac459c38/documents/IUC5-23f55fff-288e-4833-b8d9-b75b05dfc3a7_907d993d-a546-493c-a63d-5046714eb704.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hydrocarbon waxes (petroleum), oxidized, Me esters, calcium salts",68603-11-2,"ORALLD50 = > 15 mL/kg bw, male/female rat, Anonymous 1980INHALATIONIn accordance with Column 2 (adaptation statement) of Annex VIII of Regulation (EC) 1907/2006 (REACH), it is considered justified to omit the acute inhalation toxicity study required under information point 8.5.2 on the basis of exposure considerations. The nature of the registered substance means that it is not potentially inhalable.DERMALIn accordance with Section 1 of Annex XI of Regulation (EC) 1907/2006 (REACH), it is considered justified to omit the acute dermal toxicity study required under information point 8.5.3 of Annex VII on the basis of exposure considerations; no dermal absorption of the registered substance is expected to occur. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/797971ce-9c57-492d-87b1-8891ac459c38/documents/IUC5-a187c4e5-e7a8-453b-99c8-fd7189b736d6_907d993d-a546-493c-a63d-5046714eb704.html,,,,,, "Hydrocarbons, C12-30, olefin-rich, ethylene polymn. by-product",68911-05-7," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4d8e54a-c3e3-4223-955f-3e60bb128ba7/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_09b20511-0f0e-4cf4-8a3c-a725a4372f53.html,,,,,, "Hydrocarbons, C12-30, olefin-rich, ethylene polymn. by-product",68911-05-7,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4d8e54a-c3e3-4223-955f-3e60bb128ba7/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_09b20511-0f0e-4cf4-8a3c-a725a4372f53.html,,,,,, "Hydrocarbons, C14-30, olefin-rich",68514-35-2," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0ee788e-278b-4f11-8850-078f9a7bf511/documents/f1778ac0-3885-4b64-a7a1-493f7d5a1e2a_716572c2-d3ae-43d3-8f7b-0448c1a480e5.html,,,,,, "Hydrocarbons, C14-30, olefin-rich",68514-35-2,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0ee788e-278b-4f11-8850-078f9a7bf511/documents/e3ca3984-a9e9-42ab-9c51-d4f7559f2ba1_716572c2-d3ae-43d3-8f7b-0448c1a480e5.html,,,,,, "Hydrocarbons, C4 and C8, butene concentrator by-product",68606-29-1,"There is a 28 day repeat oral dosing study with triisobutylene with 14 day recovery. There are also repeat dose toxicity studies with other higher olefins spanning the range C8 to C20. The data for these studies indicate that the location of the double bond or the addition of branching to the structure do not appear to affect the toxicity. Higher olefins are of low toxicity in rats. Male rat kidney effects indicative of alpha-2u-globulin nephropathy consistently occur with the C8 to C14 higher olefins. Alpha-2u-globulin nephropathy is considered to be male rat-specific and is not relevant for humans. Treatment-related liver effects (increased organ weights, hepatocyte cytoplasmic vacuolation, and centrilobular hepatocyte hypertrophy) are also observed in rats exposed to higher olefins, which may reflect adaptive changes as a result of the high liver burden of these substances. There is no evidence of neurotoxicity. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/d99849f6-6cb7-4047-98c4-ea8c3412ed5b/documents/IUC5-487fcb89-8293-4458-af2a-952aba9b84d8_0f8d20d7-5b0d-4be0-91d1-863858509d1f.html,,,,,, "Hydrocarbons, C4 and C8, butene concentrator by-product",68606-29-1,"Acute toxicity studies exist for higher olefins including butylene oligomers at both ends of the carbon number ranges within this category. The results are consistent throughout the category and indicate low acute toxicity by the oral, dermal and inhalation routes of exposure. Butylene oligomers have low kinematic viscosity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d99849f6-6cb7-4047-98c4-ea8c3412ed5b/documents/IUC5-60b5aa01-f2d6-4905-a20c-94fe351ef9b4_0f8d20d7-5b0d-4be0-91d1-863858509d1f.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene-free",91052-98-1,"Members of the C4 low 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams in this category (CAS Numbers; 91052-98-1, 92045-23-3, 95465-89-7, 95465-90-0 and 95465-91-1) but data on the component substances (butane, isobutane and butene isomers) indicate that members of this category have low sub-chronic toxicity. Inhalation exposure is the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies in rats or mice for 6 weeks (butane and isobutane) or up to 2 years (butene isomers). Nasal lesions were observed in 2 year rodent studies on 2-methylpropene at the highest concentration and the NOAEC of 2000 ppm (4589 mg/m3) in rats is based on the lack of effect at this concentration. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/934b0863-3906-4c7c-9437-088149134842/documents/c6a47ed4-6fb5-479d-bece-95fa9e53ee21_66b78948-94c3-4cff-9a22-7d5eadd3a696.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene-free",91052-98-1,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/934b0863-3906-4c7c-9437-088149134842/documents/c6a47ed4-6fb5-479d-bece-95fa9e53ee21_66b78948-94c3-4cff-9a22-7d5eadd3a696.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"18,359 mg/m3",,rat "Hydrocarbons, C4, 1,3-butadiene-free",91052-98-1,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/934b0863-3906-4c7c-9437-088149134842/documents/c6a47ed4-6fb5-479d-bece-95fa9e53ee21_66b78948-94c3-4cff-9a22-7d5eadd3a696.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"4,589 mg/m3",adverse effect observed,rat "Hydrocarbons, C4, 1,3-butadiene-free",91052-98-1,"Members of the C4 low 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams in this category (CAS Numbers; 91052-98-1, 92045-23-3, 95465-89-7, 95465-90-0 and 95465-91-1) but data on the component substances (butane, isobutane and butene isomers) indicate that the acute inhalational toxicity of this category is low. The LC50 values for all substances are in excess of 10,000 ppm (22,948 mg/m3) and butane and isobutane are considered to be Generally Recognised as Safe and may be used in food products. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/934b0863-3906-4c7c-9437-088149134842/documents/c98bc01c-fe50-4f7c-802f-5a6cb492cafa_66b78948-94c3-4cff-9a22-7d5eadd3a696.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., dibutylene fraction",91052-99-2,"There is a 28 day repeat oral dosing study with triisobutylene with 14 day recovery. There are also repeat dose toxicity studies with other higher olefins spanning the range C8 to C20. The data for these studies indicate that the location of the double bond or the addition of branching to the structure do not appear to affect the toxicity. Higher olefins are of low toxicity in rats. Male rat kidney effects indicative of alpha-2u-globulin nephropathy consistently occur with the C8 to C14 higher olefins. Alpha-2u-globulin nephropathy is considered to be male rat-specific and is not relevant for humans. Treatment-related liver effects (increased organ weights, hepatocyte cytoplasmic vacuolation, and centrilobular hepatocyte hypertrophy) are also observed in rats exposed to higher olefins, which may reflect adaptive changes as a result of the high liver burden of these substances. There is no evidence of neurotoxicity. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/1d43b642-f0f8-4676-a744-a52b16fe0e57/documents/IUC5-ae181e9c-6f53-45e7-b0bd-f6a8521b6ae7_8b05a677-c451-4ac9-b0a5-ce59db3965d6.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., dibutylene fraction",91052-99-2,"Acute toxicity studies exist for higher olefins including butylene oligomers at both ends of the carbon number ranges within this category. The results are consistent throughout the category and indicate low acute toxicity by the oral, dermal and inhalation routes of exposure. Butylene oligomers have low kinematic viscosity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d43b642-f0f8-4676-a744-a52b16fe0e57/documents/IUC5-8b0e8e36-1e21-4ab5-a872-e336ab2f055c_8b05a677-c451-4ac9-b0a5-ce59db3965d6.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., dibutylene fraction, hydrogenated",93685-78-0,"There is a 28 day repeat oral dosing study with triisobutylene with 14 day recovery. There are also repeat dose toxicity studies with other higher olefins spanning the range C8 to C20. The data for these studies indicate that the location of the double bond or the addition of branching to the structure do not appear to affect the toxicity. Higher olefins are of low toxicity in rats. Male rat kidney effects indicative of alpha-2u-globulin nephropathy consistently occur with the C8 to C14 higher olefins. Alpha-2u-globulin nephropathy is considered to be male rat-specific and is not relevant for humans. Treatment-related liver effects (increased organ weights, hepatocyte cytoplasmic vacuolation, and centrilobular hepatocyte hypertrophy) are also observed in rats exposed to higher olefins, which may reflect adaptive changes as a result of the high liver burden of these substances. There is no evidence of neurotoxicity. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/75c96c1a-45ad-4f37-aa45-a0ac84590257/documents/IUC5-487fcb89-8293-4458-af2a-952aba9b84d8_4869b201-dd8f-4dd7-a517-0481fdc49d6f.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., dibutylene fraction, hydrogenated",93685-78-0,"Acute toxicity studies exist for higher olefins including butylene oligomers at both ends of the carbon number ranges within this category. The results are consistent throughout the category and indicate low acute toxicity by the oral, dermal and inhalation routes of exposure. Butylene oligomers have low kinematic viscosity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75c96c1a-45ad-4f37-aa45-a0ac84590257/documents/IUC5-60b5aa01-f2d6-4905-a20c-94fe351ef9b4_4869b201-dd8f-4dd7-a517-0481fdc49d6f.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., tetraisobutylene fraction",91053-00-8,"There is a 28 day repeat oral dosing study with triisobutylene with 14 day recovery. There are also repeat dose toxicity studies with other higher olefins spanning the range C8 to C20. The data for these studies indicate that the location of the double bond or the addition of branching to the structure do not appear to affect the toxicity. Higher olefins are of low toxicity in rats. Male rat kidney effects indicative of alpha-2u-globulin nephropathy consistently occur with the C8 to C14 higher olefins. Alpha-2u-globulin nephropathy is considered to be male rat-specific and is not relevant for humans. Treatment-related liver effects (increased organ weights, hepatocyte cytoplasmic vacuolation, and centrilobular hepatocyte hypertrophy) are also observed in rats exposed to higher olefins, which may reflect adaptive changes as a result of the high liver burden of these substances. There is no evidence of neurotoxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ea2e436-29cc-41e1-a965-8a99e88239ad/documents/e34248d0-0464-4f42-a6f2-c212ba496f06_dc681a5b-233f-4489-8eeb-0004bf29fd51.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., tetraisobutylene fraction",91053-00-8,"Acute toxicity studies exist for higher olefins including butylene oligomers at both ends of the carbon number ranges within this category. The results are consistent throughout the category and indicate low acute toxicity by the oral, dermal and inhalation routes of exposure. Butylene oligomers have low kinematic viscosity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ea2e436-29cc-41e1-a965-8a99e88239ad/documents/8ceef6fc-85ad-4d15-81a3-8350f75b75b0_dc681a5b-233f-4489-8eeb-0004bf29fd51.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., triisobutylene fraction",91053-01-9,"There is a 28 day repeat oral dosing study with triisobutylene with 14 day recovery. There are also repeat dose toxicity studies with other higher olefins spanning the range C8 to C20. The data for these studies indicate that the location of the double bond or the addition of branching to the structure do not appear to affect the toxicity. Higher olefins are of low toxicity in rats. Male rat kidney effects indicative of alpha-2u-globulin nephropathy consistently occur with the C8 to C14 higher olefins. Alpha-2u-globulin nephropathy is considered to be male rat-specific and is not relevant for humans. Treatment-related liver effects (increased organ weights, hepatocyte cytoplasmic vacuolation, and centrilobular hepatocyte hypertrophy) are also observed in rats exposed to higher olefins, which may reflect adaptive changes as a result of the high liver burden of these substances. There is no evidence of neurotoxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6739f4d-181f-4c30-8f10-e15a6e475ebc/documents/IUC5-ae181e9c-6f53-45e7-b0bd-f6a8521b6ae7_77479bcd-fed2-42dc-9b42-a2c8130d37fa.html,,,,,, "Hydrocarbons, C4, 1,3-butadiene-free, polymd., triisobutylene fraction",91053-01-9,"Acute toxicity studies exist for higher olefins including butylene oligomers at both ends of the carbon number ranges within this category. The results are consistent throughout the category and indicate low acute toxicity by the oral, dermal and inhalation routes of exposure. Butylene oligomers have low kinematic viscosity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6739f4d-181f-4c30-8f10-e15a6e475ebc/documents/IUC5-8b0e8e36-1e21-4ab5-a872-e336ab2f055c_77479bcd-fed2-42dc-9b42-a2c8130d37fa.html,,,,,, "Hydrocarbons, C4, butane conc., n-butene-contg.",95465-91-1,"Members of the C4 low 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams in this category (CAS Numbers; 91052-98-1, 92045-23-3, 95465-89-7, 95465-90-0 and 95465-91-1) but data on the component substances (butane, isobutane and butene isomers) indicate that members of this category have low sub-chronic toxicity. Inhalation exposure is the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies in rats or mice for 6 weeks (butane and isobutane) or up to 2 years (butene isomers). Nasal lesions were observed in 2 year rodent studies on 2-methylpropene at the highest concentration and the NOAEC of 2000 ppm (4589 mg/m3) in rats is based on the lack of effect at this concentration. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04fb854f-3dd6-4a05-bd7b-5fdc661c565d/documents/IUC5-43090578-5761-4e8c-a837-00036e32e038_a05791bf-9445-4f47-a986-ee16098061a2.html,,,,,, "Hydrocarbons, C4, butane conc., n-butene-contg.",95465-91-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04fb854f-3dd6-4a05-bd7b-5fdc661c565d/documents/IUC5-43090578-5761-4e8c-a837-00036e32e038_a05791bf-9445-4f47-a986-ee16098061a2.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"4,589 mg/m3",, "Hydrocarbons, C4, butane conc., n-butene-contg.",95465-91-1,"Members of the C4 low 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams in this category (CAS Numbers; 91052-98-1, 92045-23-3, 95465-89-7, 95465-90-0 and 95465-91-1) but data on the component substances (butane, isobutane and butene isomers) indicate that the acute inhalational toxicity of this category is low. The LC50 values for all substances are in excess of 10,000 ppm (22,948 mg/m3) and butane and isobutane are considered to be Generally Recognised as Safe and may be used in food products. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04fb854f-3dd6-4a05-bd7b-5fdc661c565d/documents/IUC5-acf1a9a9-3bbf-4f82-a000-fd3d2839ad00_a05791bf-9445-4f47-a986-ee16098061a2.html,,,,,, "Hydrocarbons, C4, butane conc., n-butene-contg.",95465-91-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04fb854f-3dd6-4a05-bd7b-5fdc661c565d/documents/IUC5-acf1a9a9-3bbf-4f82-a000-fd3d2839ad00_a05791bf-9445-4f47-a986-ee16098061a2.html,,inhalation,LC50,"22,948 mg/m3",, "Hydrocarbons, C4, ethylene-manuf.-by-product",68476-52-8," Members of the C4 high 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. Data after inhalational exposure are available on one of the streams in this category (All CAS numbers are; 68476-52-8, 68477-42-9, 68955-28-2, 87741-01-3, 92045-23-3) and on the constituent substances (1,3-butadiene, butane, isobutane and butene isomers) and indicate that the sub-chronic toxicity of this category is low. Inhalation exposure is the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in rats or mice in inhalation studies ranging from 7 weeks to 2 years on CAS no. 68476-52-82, butane, isobutane and 2-methylpropene. Nasal lesions were observed in 2 year studies on 2-methylpropene at the highest concentration in male rats. 1,3-Butadiene had low repeat dose toxicity in humans and rats (the most appropriate test species). The mouse was the most sensitive species where the target organs are bone marrow, ovary and testis. Species differences in metabolism are believed to be responsible for the species specific toxicity with humans being more similar to rats The NOAEL of 1000 ppm (2212 mg/m3) was identified from the key study on 1,3-butadiene in rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82982aa4-3432-44a9-af0c-0f186efaadd0/documents/IUC5-106b9c59-8ac8-4eb0-8b6a-307fee43b208_dab2b1ce-4ec6-4a4a-9c13-9827f4ecbf86.html,,,,,, "Hydrocarbons, C4, ethylene-manuf.-by-product",68476-52-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82982aa4-3432-44a9-af0c-0f186efaadd0/documents/IUC5-106b9c59-8ac8-4eb0-8b6a-307fee43b208_dab2b1ce-4ec6-4a4a-9c13-9827f4ecbf86.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"2,212 mg/m3",, "Hydrocarbons, C4, ethylene-manuf.-by-product",68476-52-8,"Members of the C4 high 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. Data are available on some members of the streams in this category (All CAS numbers are; 68476-52-8, 68477-42-9, 68955-28-2, 87741-01-3, 92045-23-3) and on the constituent substances (1,3-butadiene, butane, isobutane and butene isomers) and indicate that the acute inhalational toxicity of this category is low. The LC50 values are in excess of 10,000 ppm (22,948 mg/m3), limited data suggests that 1,3-butadiene is not acutely toxic in humans and butane and isobutane are considered to be Generally Recognised as Safe and may be used in food products. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82982aa4-3432-44a9-af0c-0f186efaadd0/documents/IUC5-de665b61-fce1-4b81-8865-57fe756193bf_dab2b1ce-4ec6-4a4a-9c13-9827f4ecbf86.html,,,,,, "Hydrocarbons, C4, n-butene conc.",95465-90-0,"Members of the C4 low 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on oral and dermal repeat dose toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams in this category (CAS Numbers; 91052-98-1, 92045-23-3, 95465-89-7, 95465-90-0 and 95465-91-1) but data on the component substances (butane, isobutane and butene isomers) indicate that members of this category have low sub-chronic toxicity. Inhalation exposure is the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies in rats or mice for 6 weeks (butane and isobutane) or up to 2 years (butene isomers). Nasal lesions were observed in 2 year rodent studies on 2-methylpropene at the highest concentration and the NOAEC of 2000 ppm (4589 mg/m3) in rats is based on the lack of effect at this concentration. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30fa2046-528c-4438-a0c8-6b713c159972/documents/IUC5-43090578-5761-4e8c-a837-00036e32e038_78d9a38f-aabc-4837-8834-17b24bb2ae77.html,,,,,, "Hydrocarbons, C4, n-butene conc.",95465-90-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30fa2046-528c-4438-a0c8-6b713c159972/documents/IUC5-43090578-5761-4e8c-a837-00036e32e038_78d9a38f-aabc-4837-8834-17b24bb2ae77.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"4,589 mg/m3",, "Hydrocarbons, C4, n-butene conc.",95465-90-0,"Members of the C4 low 1,3-butadiene category are flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. There are no specific studies on the streams in this category (CAS Numbers; 91052-98-1, 92045-23-3, 95465-89-7, 95465-90-0 and 95465-91-1) but data on the component substances (butane, isobutane and butene isomers) indicate that the acute inhalational toxicity of this category is low. The LC50 values for all substances are in excess of 10,000 ppm (22,948 mg/m3) and butane and isobutane are considered to be Generally Recognised as Safe and may be used in food products. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30fa2046-528c-4438-a0c8-6b713c159972/documents/IUC5-acf1a9a9-3bbf-4f82-a000-fd3d2839ad00_78d9a38f-aabc-4837-8834-17b24bb2ae77.html,,,,,, "Hydrocarbons, C4, n-butene conc.",95465-90-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30fa2046-528c-4438-a0c8-6b713c159972/documents/IUC5-acf1a9a9-3bbf-4f82-a000-fd3d2839ad00_78d9a38f-aabc-4837-8834-17b24bb2ae77.html,,inhalation,LC50,"22,948 mg/m3",, "Hydrocarbons, C4-10-unsatd.",68514-38-5," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db12ca82-7831-4bab-96a4-2a9a75a954af/documents/f1778ac0-3885-4b64-a7a1-493f7d5a1e2a_26e5dab2-fb1d-4e6a-97d1-38018778d44a.html,,,,,, "Hydrocarbons, C4-10-unsatd.",68514-38-5,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db12ca82-7831-4bab-96a4-2a9a75a954af/documents/e3ca3984-a9e9-42ab-9c51-d4f7559f2ba1_26e5dab2-fb1d-4e6a-97d1-38018778d44a.html,,,,,, "Hydrocarbons, C5, ethylene-manuf.-by-product, hydrogenated",92128-68-2,"Repeat dose studies on two C5 non-cyclics streams and two major components of these streams have been considered. There is evidence of specific target organ toxicity in several studies. A finding common to several of the studies is kidney changes characteristic of hyaline droplet nephropathy in male rats. This male rat-specific effect is considered not to be relevant to humans. Although C5 non-cyclics streams may contain low levels of benzene and/or toluene, the maximum levels present are below those which would warrant classification for specific target organ systemic toxicity after repeated exposure. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fda1399-6ab8-4516-972d-542165d74d4d/documents/IUC5-78eeeccf-fa24-48aa-b630-7078157f8945_b4332283-dc48-4a3c-9e92-c1fd0a35e0fc.html,,,,,, "Hydrocarbons, C5, ethylene-manuf.-by-product, hydrogenated",92128-68-2,"As C5 non-cyclics streams are inherently of unknown and variable composition, and taking into consideration the possible percentages of components which are acutely toxic it is proposed that all streams are classified as harmful via oral and dermal exposure routes. Two of the component substances, 2-methyl-2-butene and cyclopentene, are classified as harmful under DSD via the oral route and cyclopentene is also classified as harmful via the dermal route. 2-Methyl-2- butene vapour causes drowsiness and dizziness. Due to their low kinematic viscosity C5 non-cyclics represent an aspiration hazard. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fda1399-6ab8-4516-972d-542165d74d4d/documents/IUC5-7145f262-ecf2-4043-b14b-ec4bd0d30f6f_b4332283-dc48-4a3c-9e92-c1fd0a35e0fc.html,,,,,, "Hydrocarbons, C5-7, C6-rich, ethylene manuf. by-products",91723-50-1,"Repeated dose toxicity data are not available for the high benzene naphtha streams. However, there are substantial data on the repeated dose toxicity of a number of marker constituents present in some streams: benzene, toluene, DCPD, cyclohexane, xylene, and ethylbenzene. A number of the marker constituents demonstrate significant target organ toxicity, therefore they drive the mammalian toxicity effects in the streams (benzene and styrene - when present at 1%; toluene/  ethylbenzene / n-hexane - when present at 10%). Adequate information is available on the constituents to characterise the repeated dermal hazards of these streams. Adequate information is available on the constituents to characterise the repeated inhalation hazards of these streams. Adequate information is available on the constituents to characterise the repeated oral hazards of these streams. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18efc3c0-567e-4bbc-ba11-6cfa7a66ab84/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_ada8e382-0e9e-4a91-9b73-39ef00b0bf84.html,,,,,, "Hydrocarbons, C5-7, C6-rich, ethylene manuf. by-products",91723-50-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18efc3c0-567e-4bbc-ba11-6cfa7a66ab84/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_ada8e382-0e9e-4a91-9b73-39ef00b0bf84.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Hydrocarbons, C5-7, C6-rich, ethylene manuf. by-products",91723-50-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18efc3c0-567e-4bbc-ba11-6cfa7a66ab84/documents/IUC5-8957edab-2316-40a5-b534-01c1f499a723_ada8e382-0e9e-4a91-9b73-39ef00b0bf84.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Hydrocarbons, C5-7, C6-rich, ethylene manuf. by-products",91723-50-1,"Available data for one stream within this category (CAS 68516-20-1) and data on specific constituents (benzene, buta-1,3 -diene, toluene, n-hexane, naphthalene, isoprene and cyclohexane) that are present in some streams indicate that acute toxicity is expected to be low. CAS 68516-20-1 did not pose an acute hazard following oral or dermal (LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Xylenes are considered to be hazardous following inhalation and dermal exposure. Dicyclopentadiene is considered to be hazardous following oral and inhalation exposure. Following acute exposures to toluene in humans, a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). Adequate information is available to characterise the short-term hazards of these streams. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18efc3c0-567e-4bbc-ba11-6cfa7a66ab84/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_ada8e382-0e9e-4a91-9b73-39ef00b0bf84.html,,,,,, "Hydrocarbons, C5-7, C6-rich, ethylene manuf. by-products",91723-50-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18efc3c0-567e-4bbc-ba11-6cfa7a66ab84/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_ada8e382-0e9e-4a91-9b73-39ef00b0bf84.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C5-7, C6-rich, ethylene manuf. by-products",91723-50-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18efc3c0-567e-4bbc-ba11-6cfa7a66ab84/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_ada8e382-0e9e-4a91-9b73-39ef00b0bf84.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C5-7, C6-rich, ethylene manuf. by-products",91723-50-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18efc3c0-567e-4bbc-ba11-6cfa7a66ab84/documents/IUC5-8b3db14c-ff17-48d0-955c-1ed75afe33f1_ada8e382-0e9e-4a91-9b73-39ef00b0bf84.html,,inhalation,LC50,"20,000 mg/m3",no adverse effect observed, "Hydrocarbons, C5-8",92128-65-9,"The repeat dose toxicity data is based on constituents. The repeated dose toxicity of a number of specific constituents present in some streams i.e. benzene, toluene and n-hexane which demonstrate significant target organ toxicity and when present at concentrations greater than or equal to 1%, 10% or 10%, respectively, will drive the mammalian toxicity effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dff2034-7037-45ed-9160-b0fdfd03d8ee/documents/IUC5-c9df9a2b-e4e4-4c87-968a-c744e66e8d8f_ece57661-714c-44d2-b316-d43a5d9d95d7.html,,,,,, "Hydrocarbons, C5-8",92128-65-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dff2034-7037-45ed-9160-b0fdfd03d8ee/documents/IUC5-c9df9a2b-e4e4-4c87-968a-c744e66e8d8f_ece57661-714c-44d2-b316-d43a5d9d95d7.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,25 mg/kg bw/day,,rat "Hydrocarbons, C5-8",92128-65-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dff2034-7037-45ed-9160-b0fdfd03d8ee/documents/IUC5-c9df9a2b-e4e4-4c87-968a-c744e66e8d8f_ece57661-714c-44d2-b316-d43a5d9d95d7.html,Chronic toxicity – systemic effects,inhalation,NOAEC,11.2 mg/m3,,other:human "Hydrocarbons, C5-8",92128-65-9,"No specific acute toxicity data are available on any of the streams within this category (CAS Numbers; 102110-14-5, 64741-84-0, 64742-49-0, 68476-55-1, 92128-65-9). However there are data on constituents present in some streams which indicate that acute toxicity is expected to be low and that Aliphatics and Cyclics C5 and Higher streams do not pose an acute hazard following ingestion (oral LD50 > 2000 mg/kg), skin contact (dermal LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures. Following acute exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dff2034-7037-45ed-9160-b0fdfd03d8ee/documents/IUC5-4ae013e8-bd13-485e-a5b5-76899c29810a_ece57661-714c-44d2-b316-d43a5d9d95d7.html,,,,,, "Hydrocarbons, C5-8",92128-65-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dff2034-7037-45ed-9160-b0fdfd03d8ee/documents/IUC5-4ae013e8-bd13-485e-a5b5-76899c29810a_ece57661-714c-44d2-b316-d43a5d9d95d7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C5-8",92128-65-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dff2034-7037-45ed-9160-b0fdfd03d8ee/documents/IUC5-4ae013e8-bd13-485e-a5b5-76899c29810a_ece57661-714c-44d2-b316-d43a5d9d95d7.html,,dermal,LD50,"8,180 mg/kg bw",no adverse effect observed, "Hydrocarbons, C5-8",92128-65-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dff2034-7037-45ed-9160-b0fdfd03d8ee/documents/IUC5-4ae013e8-bd13-485e-a5b5-76899c29810a_ece57661-714c-44d2-b316-d43a5d9d95d7.html,,inhalation,LC50,"25,700 mg/m3",no adverse effect observed, "Hydrocarbons, C5-unsatd.",68956-55-8," Repeat dose studies on two C5 non-cyclics streams and two major components of these streams have been considered. There is evidence of specific target organ toxicity in several studies. A finding common to several of the studies is kidney changes characteristic of hyaline droplet nephropathy in male rats. This male rat-specific effect is considered not to be relevant to humans. Although C5 non-cyclics streams may contain low levels of benzene and/or toluene, the maximum levels present are below those which would warrant classification for specific target organ systemic toxicity after repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6eab970b-2202-41b2-bd7d-06c92c86431a/documents/IUC5-e2dae253-2c40-4ec7-8171-8bfa2e9516fc_eceb80fd-af3b-4aac-b817-8de1bbcbcac6.html,,,,,, "Hydrocarbons, C5-unsatd.",68956-55-8,"As C5 non-cyclics streams are inherently of unknown and variable composition, and taking into consideration the possible percentages of components which are acutely toxic it is proposed that all streams are classified as harmful via oral and dermal exposure routes. Two of the component substances, 2-methyl-2-butene and cyclopentene, are classified as harmful under DSD via the oral route and cyclopentene is also classified as harmful via the dermal route. 2-Methyl-2- butene vapour causes drowsiness and dizziness. Due to their low kinematic viscosity C5 non-cyclics represent an aspiration hazard. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6eab970b-2202-41b2-bd7d-06c92c86431a/documents/IUC5-4a1915b2-ab0e-4c0e-88eb-eaf7b3efde7f_eceb80fd-af3b-4aac-b817-8de1bbcbcac6.html,,,,,, "Hydrocarbons, C6-8, hydrogenated sorption-dearomatized, toluene raffination",101316-66-9,"There are data for repeat exposure to one low benzene naphtha streams representing the inhalation route of exposure and a related stream representing the dermal route. These do not indicate any specific target organ toxicity which would warrant classification. However, there are substantial data on the repeated dose toxicity of toluene which demonstrates significant target organ toxicity and, when present at concentrations greater than or equal to 10%, this component substance will influence classification due to mammalian toxicity effects. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd0eb149-c315-4ec7-a0ba-085449151019/documents/IUC5-5ebdb270-43bf-44d5-a290-f9b00c6dc994_7e3a370f-b5c9-447d-a91e-4008a6aedbde.html,,,,,, "Hydrocarbons, C6-8, hydrogenated sorption-dearomatized, toluene raffination",101316-66-9,"Available non-human data for CAS 68516-20-1, a low benzene naphtha stream and supporting data from one related stream (CAS 64741-68-0) and data on the specific component toluene, indicate that acute toxicity is expected to be low. Low benzene naphtha streams do not pose an acute hazard following ingestion (oral LD50 > 2000 mg/kg bw) or skin contact (dermal LD50 > 2000 mg/kg). The acute inhalation 4 hour LC50 is greater than saturated vapour pressure for the two streams considered and > 20 mg/L for toluene. However following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and labelling (R67) will be required as low benzene naphtha streams contain up to 50% toluene. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd0eb149-c315-4ec7-a0ba-085449151019/documents/IUC5-61013f97-5867-4af8-85bd-6f43621fa2e6_7e3a370f-b5c9-447d-a91e-4008a6aedbde.html,,,,,, "Hydrocarbons, C6-rich, hydrotreated light naphtha distillates, solvent-refined",101316-67-0,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/1fb69811-758e-4339-9c42-373d60a6c5a3/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_ee4a7161-79fb-4e49-87c8-132399f11b7c.html,,,,,, "Hydrocarbons, C6-rich, hydrotreated light naphtha distillates, solvent-refined",101316-67-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/1fb69811-758e-4339-9c42-373d60a6c5a3/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_ee4a7161-79fb-4e49-87c8-132399f11b7c.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Hydrocarbons, C6-rich, hydrotreated light naphtha distillates, solvent-refined",101316-67-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/1fb69811-758e-4339-9c42-373d60a6c5a3/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_ee4a7161-79fb-4e49-87c8-132399f11b7c.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Hydrocarbons, C6-rich, hydrotreated light naphtha distillates, solvent-refined",101316-67-0," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fb69811-758e-4339-9c42-373d60a6c5a3/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_ee4a7161-79fb-4e49-87c8-132399f11b7c.html,,,,,, "Hydrocarbons, C6-rich, hydrotreated light naphtha distillates, solvent-refined",101316-67-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fb69811-758e-4339-9c42-373d60a6c5a3/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_ee4a7161-79fb-4e49-87c8-132399f11b7c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C6-rich, hydrotreated light naphtha distillates, solvent-refined",101316-67-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fb69811-758e-4339-9c42-373d60a6c5a3/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_ee4a7161-79fb-4e49-87c8-132399f11b7c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C6-rich, hydrotreated light naphtha distillates, solvent-refined",101316-67-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fb69811-758e-4339-9c42-373d60a6c5a3/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_ee4a7161-79fb-4e49-87c8-132399f11b7c.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Hydrocarbons, C9, aromatics",128601-23-0," Hydrocarbons, C9 Aromatics: Repeated Dose Oral 90d – NOAEL = 600 mg/Kg bw for rats (similar to OECD TG 408) Repeated Dose Inhalation 12 month – NOAEC = 900 mg/m3 for rats (similar to OECD TG 413) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a799c3b4-ba4e-4bd5-924e-907c7318901c/documents/1201476f-5f70-441f-8e4d-84d0fd1715ee_89da6ed6-01f9-4852-9f5e-50000a0e729c.html,,,,,, "Hydrocarbons, C9, aromatics",128601-23-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a799c3b4-ba4e-4bd5-924e-907c7318901c/documents/1201476f-5f70-441f-8e4d-84d0fd1715ee_89da6ed6-01f9-4852-9f5e-50000a0e729c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat "Hydrocarbons, C9, aromatics",128601-23-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a799c3b4-ba4e-4bd5-924e-907c7318901c/documents/1201476f-5f70-441f-8e4d-84d0fd1715ee_89da6ed6-01f9-4852-9f5e-50000a0e729c.html,Chronic toxicity – systemic effects,inhalation,NOAEC,900 mg/m3,,rat "Hydrocarbons, C9, aromatics",128601-23-0," Hydrocarbons, C9 Aromatics:   Acute Oral LD50 = 3492 mg/Kg in rats (OECD TG 401) Acute Dermal LD50 >3160 mg/Kg bw in rabbits (OECD TG 402) Acute Inhalation LC50 >maximal attainable vapor concentration in rats (OECD TG 403)   Hydrocarbons, C10 Aromatics, >1% Naphthalene: Acute Oral LD50 = 6318 mg/Kg in rats (OECD TG 401) Acute Dermal LD50 >2000 mg/Kg in rabbits (OECD TG 402) Acute Inhalation LC50 >4688 mg/m3 (OECD TG 403) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a799c3b4-ba4e-4bd5-924e-907c7318901c/documents/b6a98fe8-8498-4cea-adb2-a574da5a2a9c_89da6ed6-01f9-4852-9f5e-50000a0e729c.html,,,,,, "Hydrocarbons, C9, aromatics",128601-23-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a799c3b4-ba4e-4bd5-924e-907c7318901c/documents/b6a98fe8-8498-4cea-adb2-a574da5a2a9c_89da6ed6-01f9-4852-9f5e-50000a0e729c.html,,oral,LD50,"3,492 mg/kg bw",adverse effect observed, "Hydrocarbons, C9, aromatics",128601-23-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a799c3b4-ba4e-4bd5-924e-907c7318901c/documents/b6a98fe8-8498-4cea-adb2-a574da5a2a9c_89da6ed6-01f9-4852-9f5e-50000a0e729c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C9, aromatics",128601-23-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a799c3b4-ba4e-4bd5-924e-907c7318901c/documents/b6a98fe8-8498-4cea-adb2-a574da5a2a9c_89da6ed6-01f9-4852-9f5e-50000a0e729c.html,,inhalation,LC50,"6,193 mg/m3",no adverse effect observed, "Hydrocarbons, C9-16, hydrotreated, dearomatized",93763-35-0,"A number of subacute and subchronic studies with kerosines and jet fuels are available (OECD 410, 412, 413, and other non-guideline protocols). The repeated inhalation and oral studies of kerosine in rats produced no consistent toxicological effects other than changes in male rat kidneys that are not considered relevant to humans. The NOAEC for inhalation exposure is greater than or equal to 1000 mg/m3 (vapour).  The systemic dermal NOAEL is greater than or equal to 495 mg/kg bw/day, based on a well conducted 90-day study in rats.  The NOAEL for systemic effects of oral exposure is 750 mg/kg/day. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/27f1a54e-c5c4-4468-b38d-85e9fd71645d/documents/89277e09-fd6a-4778-85aa-41521a1ff043_526dbf62-4154-4372-b807-666e97578d64.html,,,,,, "Hydrocarbons, C9-16, hydrotreated, dearomatized",93763-35-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/27f1a54e-c5c4-4468-b38d-85e9fd71645d/documents/89277e09-fd6a-4778-85aa-41521a1ff043_526dbf62-4154-4372-b807-666e97578d64.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Hydrocarbons, C9-16, hydrotreated, dearomatized",93763-35-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/27f1a54e-c5c4-4468-b38d-85e9fd71645d/documents/89277e09-fd6a-4778-85aa-41521a1ff043_526dbf62-4154-4372-b807-666e97578d64.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,495 mg/kg bw/day,,rat "Hydrocarbons, C9-16, hydrotreated, dearomatized",93763-35-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/27f1a54e-c5c4-4468-b38d-85e9fd71645d/documents/89277e09-fd6a-4778-85aa-41521a1ff043_526dbf62-4154-4372-b807-666e97578d64.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat "Hydrocarbons, C9-16, hydrotreated, dearomatized",93763-35-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/27f1a54e-c5c4-4468-b38d-85e9fd71645d/documents/89277e09-fd6a-4778-85aa-41521a1ff043_526dbf62-4154-4372-b807-666e97578d64.html,Repeated dose toxicity – local effects,dermal,LOAEL,1 mg/cm2,adverse effect observed,rat "Hydrocarbons, C9-16, hydrotreated, dearomatized",93763-35-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/27f1a54e-c5c4-4468-b38d-85e9fd71645d/documents/89277e09-fd6a-4778-85aa-41521a1ff043_526dbf62-4154-4372-b807-666e97578d64.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,000 mg/m3",no adverse effect observed,rat "Hydrocarbons, C9-16, hydrotreated, dearomatized",93763-35-0,"Kerosines are of low acute toxicity with mortality rarely reported even at very high exposures in experimental animal studies conducted by oral (similar to OECD 420), dermal (similar to OECD 402), and inhalation (similar to OECD 403) exposure.  • The oral LD50 was > 5000 mg/kg bw in male and female rats for kerosine.• The dermal LD50 was > 2000 mg/kg/bw in male and female rabbits for kerosine.• The inhalation LC50 was > 5.28 mg/L vapour in male and female rats for kerosine. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27f1a54e-c5c4-4468-b38d-85e9fd71645d/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_526dbf62-4154-4372-b807-666e97578d64.html,,,,,, "Hydrocarbons, C9-16, hydrotreated, dearomatized",93763-35-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27f1a54e-c5c4-4468-b38d-85e9fd71645d/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_526dbf62-4154-4372-b807-666e97578d64.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C9-16, hydrotreated, dearomatized",93763-35-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27f1a54e-c5c4-4468-b38d-85e9fd71645d/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_526dbf62-4154-4372-b807-666e97578d64.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrocarbons, C9-16, hydrotreated, dearomatized",93763-35-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27f1a54e-c5c4-4468-b38d-85e9fd71645d/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_526dbf62-4154-4372-b807-666e97578d64.html,,inhalation,LC50,"5,280 mg/m3",no adverse effect observed, "Hydrocarbons, ethylene-manuf.-by-product distn. residues",68921-67-5,"The limited repeat dose toxicity data on specific streams identified for this category (dermal toxicity studies for API 83-04 [light catalytic reformed naphtha] and API 83-05 [catalytic reformed naphtha]) provided no evidence of systemic target organ toxicity. However, there are substantial data on the repeated dose toxicity of a number of specific components present in some streams i.e. benzene, toluene and hexane which demonstrate significant target organ toxicity and when present at concentrations greater than or equal to 1%, 10% or 10% respectively will drive the mammalian toxicity effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5176c591-294d-421d-bbbd-7234aaa728d2/documents/IUC5-d2198eb0-d1c7-4edd-8f78-52aac5916a77_d6bc228d-5f3f-41e8-8abe-50dd1864ce99.html,,,,,, "Hydrocarbons, ethylene-manuf.-by-product distn. residues",68921-67-5,"Available data for one stream within this category (CAS 68516-20-1), two related streams (API 83-04 [light catalytic reformed naphtha], API 83-05 [catalytic reformed naphtha]), summary information available for pyrolysis gasoline (68606-10-0, 68921-67-5, 64742-91-2, 68955-29-3) and data on specific components (benzene, toluene, hexane, xylenes, 1,3-butadiene, naphthalene, isoprene and anthracene) that are present in some streams indicate that acute toxicity is expected to be low. High Benzene Naphtha streams do not pose an acute hazard following skin contact (dermal LD50 > 5000 mg/kg) or acute inhalation (4 hour LC50 > 20 mg/L) exposures although streams containing a high proportion of naphthalene (≥25%) are expected to be hazardous following oral exposures. Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans and is classified R22. Xylenes are considered to be hazardous following inhalation and dermal exposures (classified R20 and R21) the concentration within High Benzene Naphtha streams (greater than or equal to 12.5%) may trigger classification. Following acute inhalation exposures toluene and n-hexane can cause neurobehavioural effects and classification (R67) will be required for streams containing a total concentration of toluene and n-hexane of ≥20 %. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5176c591-294d-421d-bbbd-7234aaa728d2/documents/IUC5-0bd9c7f1-09db-445b-bf1d-05b0ebdf86da_d6bc228d-5f3f-41e8-8abe-50dd1864ce99.html,,,,,, "Hydrocarbons, steam-cracking tar middle",86290-83-7,"There are limited repeat dose toxicity data on any of the specific streams identified for this category. However, there are substantial data on the repeated dose toxicity of a number of specific components present in some streams i.e. benzene, toluene, ethylbenzene and styrene which demonstrate significant target organ toxicity. Classification will be required for streams that contain benzene or toluene at concentrations greater than or equal to 1%or 10% respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5c607e6-0478-4c2c-8ddb-9ae935e9fc41/documents/IUC5-2eacf0cb-ed53-4d6d-a900-c09c54ab0f7a_3dca63f4-b2e6-40ae-85d2-7fcd75283fd2.html,,,,,, "Hydrocarbons, steam-cracking tar middle",86290-83-7,"Available data for 4 specific streams within this category [Carbon Black Oil (CAS 64742-90-1), E000014200 (CAS 68475-80-9), Rohnaphthalin-Gemisch (CAS 85117-10-8), Quenchoel (CAS 98072-36-7)], further information included in the Category Summary for Fuel Oils Category (ACC, 2005), and on specific components (benzene, toluene, ethylbenzene, styrene, naphthalene, biphenyl and anthracene) that are present in some streams indicate that acute toxicity is expected to be low. Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Therefore, classification will be required for streams containing a high proportion of naphthalene (≥25%) and styrene (>12.5%) but the highest concentration of ethylbenzene (10%) is too low to trigger classification. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (R67/H336) will be required for streams containing ≥20% toluene. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5c607e6-0478-4c2c-8ddb-9ae935e9fc41/documents/IUC5-afc14175-f5f0-49c2-af24-494f70248dc4_3dca63f4-b2e6-40ae-85d2-7fcd75283fd2.html,,,,,, "Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts",90411-76-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A reliable study which was perforemed according to OECD TG 407 and GLP with Klimisch Score 1; no other study available ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a90f4739-b62a-4891-a916-0c6cba252f1f/documents/IUC5-47b29dbe-6299-4578-8516-7034f30df9cd_f7316f33-9c4c-45c5-89f0-3b7eeddc4e3c.html,,,,,, "Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts",90411-76-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a90f4739-b62a-4891-a916-0c6cba252f1f/documents/IUC5-47b29dbe-6299-4578-8516-7034f30df9cd_f7316f33-9c4c-45c5-89f0-3b7eeddc4e3c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts",90411-76-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is performed similiar to the current guideline and has Klimisch Score 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): the study is a guideline study and is GLP compliant and has Klimisch Score 1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a90f4739-b62a-4891-a916-0c6cba252f1f/documents/IUC5-9789c566-a2f5-4c11-b5ea-74f595d7b4a2_f7316f33-9c4c-45c5-89f0-3b7eeddc4e3c.html,,,,,, "Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts",90411-76-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a90f4739-b62a-4891-a916-0c6cba252f1f/documents/IUC5-9789c566-a2f5-4c11-b5ea-74f595d7b4a2_f7316f33-9c4c-45c5-89f0-3b7eeddc4e3c.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Hydrochloric acid, reaction products with aniline and nitrobenzene, sulfonated, sodium salts",90411-76-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a90f4739-b62a-4891-a916-0c6cba252f1f/documents/IUC5-9789c566-a2f5-4c11-b5ea-74f595d7b4a2_f7316f33-9c4c-45c5-89f0-3b7eeddc4e3c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Hydrogen (glycinato-N,O)[sulphato(2-)-O,O']ferrate(1-)",17169-60-7,"- study conducted according to OECD test guideline 407 (14-d DRF), result: NOAEL = 1000 mg/kg bw - published study (Shibui et al., 2013) conducted similar to OECD test guideline 407, treatment weeks with glycine, result: NOAEL = 1000 mg/kg bw/d - published study (Appel et al., 2001) conducted similar to OECD test guideline 407, treatment 31 and 62 days, result: NOAEL = 11.5 mg Fe/kg bw/d - published study (Sato et al., 1992) conducted similar to OECD test guideline 407, treatment 13 weeks and 2 years, treatment via drinking water, result: Based on the accumulation of iron in various organs the LOEL is  0.25% corresponding to 69.7 mg/kg bw/day in males and 187.9 mg/kg bw/day in females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65240c07-13d4-440a-9e49-4a68a7680a03/documents/28467bce-7f16-4466-bc55-de82a94d2b1e_ab033c99-8cf5-4d7f-b0c0-cc70856a68d6.html,,,,,, "Hydrogen (glycinato-N,O)[sulphato(2-)-O,O']ferrate(1-)",17169-60-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/65240c07-13d4-440a-9e49-4a68a7680a03/documents/28467bce-7f16-4466-bc55-de82a94d2b1e_ab033c99-8cf5-4d7f-b0c0-cc70856a68d6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hydrogen (glycinato-N,O)[sulphato(2-)-O,O']ferrate(1-)",17169-60-7,"-study conducted according to OECD test guideline 425 with ferrous lysinate, result: LD50 for ferrous monolysinate sulfate is > 2000 mg/kg - Weaver et al., 1961, study conducted according to OECD test guideline 401 with ferrous monoglycinate sulfate, result: Oral LD50 Female/Male Combined = 5590 mg/kg bw -Tobilli et al., 2008, study conducted according to OECD test guideline 401 with ferrous monoglycinate sulfate, result: The LD50 value was reported to be > 2800 mg Fe/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65240c07-13d4-440a-9e49-4a68a7680a03/documents/98155bc3-1936-444b-ae7a-8aa5ca245b1e_ab033c99-8cf5-4d7f-b0c0-cc70856a68d6.html,,,,,, "Hydrogen (glycinato-N,O)[sulphato(2-)-O,O']ferrate(1-)",17169-60-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65240c07-13d4-440a-9e49-4a68a7680a03/documents/98155bc3-1936-444b-ae7a-8aa5ca245b1e_ab033c99-8cf5-4d7f-b0c0-cc70856a68d6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-),52277-71-1," Oral: In an acute oral toxicity study similar to OECD 401 guideline, a LD50 of above 5000 mg/kg bw was determined (Stahl, 1980). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d95cc37-ae35-4a42-93d5-df761200b96e/documents/8c841f2e-12c5-464e-9c4e-f1cbc8cd8bcb_3bd7d136-c12b-4512-ba4f-7ad05c502d13.html,,,,,, Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-),52277-71-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d95cc37-ae35-4a42-93d5-df761200b96e/documents/8c841f2e-12c5-464e-9c4e-f1cbc8cd8bcb_3bd7d136-c12b-4512-ba4f-7ad05c502d13.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-),52277-71-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d95cc37-ae35-4a42-93d5-df761200b96e/documents/8c841f2e-12c5-464e-9c4e-f1cbc8cd8bcb_3bd7d136-c12b-4512-ba4f-7ad05c502d13.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Hydrogen [1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)][1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)",72812-34-1,In an acute oral gavage study no adverse effects were recorded after application of the limit dose. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f18d67c-e784-4ede-b920-e4ce275b32da/documents/IUC5-77801b68-5ad6-42a5-b588-e3885e634e56_90fbd207-0a41-42a1-80c0-a2e4f9719012.html,,,,,, "Hydrogen [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-)",72928-81-5,LD50(oral) > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1880fcb4-819a-4347-957d-472d623a0a69/documents/d4658e4b-a248-47d5-94e2-bc0eb5cbd691_ad9340ea-e547-4e23-9998-cf615a257655.html,,,,,, "Hydrogen [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",52256-39-0," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target substance Hydrogen [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][2-[(4,5-dihydro-3 -methyl -5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-) (52256-39-0) was estimated to be 4443.79 mg/kg bw,and for different studies available on the structurally similar read across substance 4,4'-(1E,1'E)-(3,3'-dichlorobiphenyl-4,4'-diyl)bis(diazene-2,1-diyl)bis(3-methyl-1-phenyl-1H-pyrazol-5(4H)-one) (3520-72-7) was considered to be >5000 mg/kg bw;for 2,2'-[(3,3'-dichlorobiphenyl-4,4'-diyl)didiazene-2,1-diyl]bis(3-oxo-N-phenylbutanamide) (CAS no: 6358-85-6) was considered to be >11000 mg/kg bw and for Disodium hydrogen bis[5-chloro-3-[(4,5-dihydro-3-methyl-5 -oxo-1-phenyl-1H -pyrazol-4- yl)azo]-2- hydroxybenzenesulphonato(3-)]chromate(3-) (6408-26-0) was considered to be >15000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Hydrogen [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][2-[(4,5-dihydro-3-methyl -5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-) (52256-39-0) cannot be classified for acute oral toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18df63bc-7c39-4dde-8336-58f09cf986cc/documents/64bac515-9055-4560-8664-36e09299384b_6b9737fc-5960-4116-970b-74c5bbe5ed87.html,,,,,, "Hydrogen [2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",52256-39-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18df63bc-7c39-4dde-8336-58f09cf986cc/documents/64bac515-9055-4560-8664-36e09299384b_6b9737fc-5960-4116-970b-74c5bbe5ed87.html,,oral,LD50,"4,443.79 mg/kg bw",no adverse effect observed, "Hydrogen [29H,31H-phthalocyaninesulphonato(2-)-N29,N30,N31,N32]cuprate(1-), compound with (Z)-octadec-9-enylamine (1:1)",85650-96-0,Information on the substance itself and an analogue substance show that the substance is of low acute oral toxicity in rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4943f897-7e98-4657-800b-cbdcbea1d2d5/documents/IUC5-593673d2-3123-43bb-bccc-19128523da6a_3e534021-6979-42c4-bfce-0c6a446213df.html,,,,,, "Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-)",28901-96-4,"No adverse findings were observed at the limit dose of 2000 mg/kg bw in rats (OECD 423, GLP). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c441149d-24dc-4149-baa9-24fe1e26f9ec/documents/IUC5-3913b54e-7276-4fbb-8191-be6e9124b6e1_cd105d18-8a2b-409c-a87b-2f7c4bead93b.html,,,,,, "Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-)",28901-96-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c441149d-24dc-4149-baa9-24fe1e26f9ec/documents/IUC5-3913b54e-7276-4fbb-8191-be6e9124b6e1_cd105d18-8a2b-409c-a87b-2f7c4bead93b.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with dodecylamine (1:1)",73455-75-1,"Subacute gavage dosing of rats caused histopathology findings in liver, mesenteric lymph nodes, kidneys (males only) and adrenal glands (males only) at 1000 mg/kg bw. The NOEL is 300 mg/kg bw. The study was performed accoring to OECD guideline 422 and under GLP. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0cba332c-2838-4e17-93a3-d761436c0a00/documents/IUC5-080dfe62-fd2c-4b8d-8f3f-f8eac026b29e_041d4ed2-d53d-4e09-a787-571ce178be9b.html,,,,,, "Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with dodecylamine (1:1)",73455-75-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0cba332c-2838-4e17-93a3-d761436c0a00/documents/IUC5-080dfe62-fd2c-4b8d-8f3f-f8eac026b29e_041d4ed2-d53d-4e09-a787-571ce178be9b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with dodecylamine (1:1)",73455-75-1,"In an acute oral toxicity study with rats (OECD 423, GL), the LD50 was >2000 mg/kg bw and no indication of toxicity was observed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0cba332c-2838-4e17-93a3-d761436c0a00/documents/IUC5-e5537e1c-e38f-436a-8bb1-6db85df4902b_041d4ed2-d53d-4e09-a787-571ce178be9b.html,,,,,, "Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with dodecylamine (1:1)",73455-75-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0cba332c-2838-4e17-93a3-d761436c0a00/documents/IUC5-e5537e1c-e38f-436a-8bb1-6db85df4902b_041d4ed2-d53d-4e09-a787-571ce178be9b.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Hydrogen [29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with dodecylamine (1:1)",73455-75-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0cba332c-2838-4e17-93a3-d761436c0a00/documents/IUC5-e5537e1c-e38f-436a-8bb1-6db85df4902b_041d4ed2-d53d-4e09-a787-571ce178be9b.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Hydrogen [3-[[1-[anilinocarbonyl]-2-oxopropyl]azo]-2-hydroxy-5-nitrobenzene-1-sulphonato(3-)]hydroxychromate(1-) , compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)",94276-33-2," Oral: In an acute oral toxicity study according to OECD Guideline 423 (acute toxicity class method) in rats (BASF Colors&Effects, 2017), an LD50 above 2000 mg/kg bw was determined. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e566b564-61fc-4877-b3b1-693a7e652f53/documents/94d42386-068d-499b-8c63-691794dff217_b87211ed-6419-4f14-aa61-470581c52b76.html,,,,,, "Hydrogen [4-[[4-(diethylamino)-o-tolyl][4-[ethyl(3-sulphonatobenzyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt",5863-46-7, LD50 > 5000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/782e7a89-a63d-45a2-8923-18f047906434/documents/131115c1-a95d-4fa4-b8e3-7341bb100419_c6a67f31-c566-4865-8ff4-c940183066df.html,,,,,, "Hydrogen [4-[[4-(diethylamino)-o-tolyl][4-[ethyl(3-sulphonatobenzyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt",5863-46-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/782e7a89-a63d-45a2-8923-18f047906434/documents/131115c1-a95d-4fa4-b8e3-7341bb100419_c6a67f31-c566-4865-8ff4-c940183066df.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrogen [4-[[4-(diethylamino)phenyl][4-[ethyl(3-sulphonatobenzyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt",4129-84-4, LD50 > 5000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5f2d6c0-c1db-426d-af41-91b5cb4f164b/documents/91d6d8fd-ffd1-425b-a539-aab67fe55ae1_5ee0897f-32dc-4c7e-8469-011b9432f3d6.html,,,,,, "Hydrogen [4-[[4-(diethylamino)phenyl][4-[ethyl(3-sulphonatobenzyl)amino]phenyl]methylene]cyclohexa-2,5-dien-1-ylidene](ethyl)(3-sulphonatobenzyl)ammonium, sodium salt",4129-84-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5f2d6c0-c1db-426d-af41-91b5cb4f164b/documents/91d6d8fd-ffd1-425b-a539-aab67fe55ae1_5ee0897f-32dc-4c7e-8469-011b9432f3d6.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, aluminium salt",15876-40-1," Repeated dose toxicity: Oral Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa- 2,5-dien -1-ylidene] diethylammonium, aluminium salt. The study assumed the use of male and female Wistar rats in a study of upto 28 days. No significant alterations were noted at the dose level of 525 mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, aluminium salt is considered to be 525 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/874bd3b5-847a-4f55-a1b6-63113140d215/documents/f98878be-c559-470b-a544-0a5f9681e80d_37e86d05-e376-4d51-803c-d56779e47531.html,,,,,, "Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, aluminium salt",15876-40-1,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/874bd3b5-847a-4f55-a1b6-63113140d215/documents/f98878be-c559-470b-a544-0a5f9681e80d_37e86d05-e376-4d51-803c-d56779e47531.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,525 mg/kg bw/day,,rat "Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, aluminium salt",15876-40-1," Acute oral toxicity:  LD50 was estimated to be 506 mg/kg bw when male and female Wistar rats were treated with Hydrogen (4-(4-(diethylamino)-2',4'-disulphonatobenzhydrylidene)cyclohexa-2,5-dien-1-ylidene)diethylammonium, aluminium salt via oral gavage route. Based on the prediction on Hydrogen (4-(4-(diethylamino)-2',4'-disulphonatobenzhydrylidene) cyclohexa-2,5-dien-1-ylidene)diethylammonium, aluminium salt (15876-40-1) and it’s read across substances, it can be concluded that LD50 value is between 300 - 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Hydrogen (4-(4-(diethylamino)-2',4'-disulphonatobenzhydrylidene) cyclohexa-2,5-dien-1-ylidene)diethylammonium, aluminium salt can be classified as category IV for acute oral toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/874bd3b5-847a-4f55-a1b6-63113140d215/documents/5b9b9db0-6355-48d6-bca5-00c956e0236c_37e86d05-e376-4d51-803c-d56779e47531.html,,,,,, "Hydrogen [4-[4-(diethylamino)-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, aluminium salt",15876-40-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/874bd3b5-847a-4f55-a1b6-63113140d215/documents/5b9b9db0-6355-48d6-bca5-00c956e0236c_37e86d05-e376-4d51-803c-d56779e47531.html,,oral,LD50,506 mg/kg bw,adverse effect observed, "Hydrogen [4-[4-(diethylamino)-5'-hydroxy-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, monosodium salt",20262-76-4, NOAEL = 500 mg/kg bw/day LOAEL = 1500 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c918720-b823-4449-a22d-1a7f2e0771f2/documents/46c6c0b9-7147-4525-a65f-c099233162fb_75bd9828-5563-4078-9465-d807efceb401.html,,,,,, "Hydrogen [4-[4-(diethylamino)-5'-hydroxy-2',4'-disulphonatobenzhydrylidene]cyclohexa-2,5-dien-1-ylidene]diethylammonium, monosodium salt",20262-76-4," LD50 rat oral route > 5000 mg/kg/bw, LD50 mouse oral route > 3000 mg/Kg/bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c918720-b823-4449-a22d-1a7f2e0771f2/documents/33223072-5738-4390-8c3d-4cb219924b26_75bd9828-5563-4078-9465-d807efceb401.html,,,,,, "Hydrogen [4-[4-(p-ethoxyanilino)-4'-[ethyl(m-sulphonatobenzyl)amino]-2'-methylbenzhydrylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(m-sulphonatobenzyl)ammonium, monosodium salt",6104-58-1,The acute oral median lethal dose (LD50) of FAT 20085/A in rats (both sexes) is greater than 5000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c11c43c-08e8-49f8-8785-38382b1d9c79/documents/IUC5-1e31b15d-ef7c-42fe-96b3-39b41b29bef5_2a411bcf-190e-45e7-ae4a-3bd04a4c8531.html,,,,,, "Hydrogen [4-[4-(p-ethoxyanilino)-4'-[ethyl(m-sulphonatobenzyl)amino]-2'-methylbenzhydrylene]-3-methylcyclohexa-2,5-dien-1-ylidene](ethyl)(m-sulphonatobenzyl)ammonium, monosodium salt",6104-58-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c11c43c-08e8-49f8-8785-38382b1d9c79/documents/IUC5-1e31b15d-ef7c-42fe-96b3-39b41b29bef5_2a411bcf-190e-45e7-ae4a-3bd04a4c8531.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrogen [tris[[[3-[(2-ethylhexyl)oxy]propyl]amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)",94277-77-7,"The endpoint is assessed in a weight-of-evidence assessment. Most importantly, no adverse effects were observed in a GLP-compliant gavage study with rats that followed OECD testing guideline 422 (BASF 2013) performed with the main structural analogue. Feces showed the colour of the test item indicated gastrointestinal passage. The highest tested dose was the limit dose required by the guideline (1000 mg/kg bw). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66a1bb2e-4b48-4754-871c-9ad781e15475/documents/IUC5-c6df2900-729c-4e82-b1ea-920ff7d5f424_93c5f9d8-e8c3-446a-b282-d675abe801a1.html,,,,,, "Hydrogen [tris[[[3-[(2-ethylhexyl)oxy]propyl]amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)",94277-77-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66a1bb2e-4b48-4754-871c-9ad781e15475/documents/IUC5-c6df2900-729c-4e82-b1ea-920ff7d5f424_93c5f9d8-e8c3-446a-b282-d675abe801a1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hydrogen [tris[[[3-[(2-ethylhexyl)oxy]propyl]amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)",94277-77-7,The substance was found to be non-hazardous upon gavage dosing of rats and it was of low toxicity upon intraperitoneal injection of rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66a1bb2e-4b48-4754-871c-9ad781e15475/documents/IUC5-df5f496e-3eb6-47f9-9b95-3445080784b2_93c5f9d8-e8c3-446a-b282-d675abe801a1.html,,,,,, "Hydrogen [tris[[[3-[(2-ethylhexyl)oxy]propyl]amino]sulphonyl]-29H,31H-phthalocyaninesulphonato(3-)-N29,N30,N31,N32]cuprate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)",94277-77-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66a1bb2e-4b48-4754-871c-9ad781e15475/documents/IUC5-df5f496e-3eb6-47f9-9b95-3445080784b2_93c5f9d8-e8c3-446a-b282-d675abe801a1.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "Hydrogen 9-amino-7-phenyl-5-(phenylamino)-4,10-disulphonatobenzo[a]phenazinium, disodium salt",72749-80-5, The No Observed Adverse Effect Level (NOAEL) of the test item Acid Violet 50 was found to be 1000 mg/kg body weight when administered to the males for a total of 37 days and to the females for up to 50 days under the experimental conditions employed. No toxic effects were observed. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8433d2ad-ee81-4326-b7d4-87c3cc5237a4/documents/151ca297-abae-4b3f-b9da-0c72e4242ba9_71ac3072-42bb-497c-9e99-66234287a992.html,,,,,, "Hydrogen 9-amino-7-phenyl-5-(phenylamino)-4,10-disulphonatobenzo[a]phenazinium, disodium salt",72749-80-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8433d2ad-ee81-4326-b7d4-87c3cc5237a4/documents/151ca297-abae-4b3f-b9da-0c72e4242ba9_71ac3072-42bb-497c-9e99-66234287a992.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Hydrogen 9-amino-7-phenyl-5-(phenylamino)-4,10-disulphonatobenzo[a]phenazinium, disodium salt",72749-80-5," A group of three fasted females was treated with the test item at a dose level of 2112 mg/kg body weight (equivalent to 2000 mg active ingredient/kg body weight). This was followed by a further group of three fasted females at the same dose level. Dosing was performed sequentially. The test item was administered orally as a suspension in distilled water. During the 14 day observation period, clinical signs and body weight development were monitored. Thereafter all animals were subjected to gross necropsy. Results: There were no deaths. There were no signs of systemic toxicity. Black staining of the feces was noted in the cage of the second group of animals. All animals showed expected gains in body weight. No abnormalities were noted at necropsy. Conclusion: The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2112 mg/kg body weight (equivalent to 2000 mg active ingredient/kg body weight) (Globally Harmonized Classification System - Unclassified). The test item Acid Violet 50 was evaluated for Acute Dermal Toxicity in Sprague Dawley Rats as per the OECD guideline for the testing of chemicals No. 402, “Acute Dermal Toxicity - Fixed Dose Procedure”. The animals were dosed in a stepwise procedure with one female at a time in range finding study. A starting dose of 2000 mg/kg body weight was selected. No clinical signs and mortalities were observed at the dose level of2000 mg/kg body weight in range finding study. Hence, during main study, two animals were administered with the same dose level of 2000 mg/kg body weight. No clinical signs and mortalities were observed at the dose level of 2000 mg/kg body weight. Hence, no further testing was carried out. No mortality, clinical signs and skin reactions were noted. No treatment related changes in body weight and percent change in body weight with respect to day 1 were noted. Normal increase in body weights were noted during the observation period. No treatment related gross pathological changes were noted at 2000 mg/kg body weight during necropsy. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8433d2ad-ee81-4326-b7d4-87c3cc5237a4/documents/140f4267-651b-47c8-a61c-cca827cab3d9_71ac3072-42bb-497c-9e99-66234287a992.html,,,,,, "Hydrogen bis[2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-mesylphenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)]chromate(1-)",71598-35-1," Acute oral toxicity:  Acute oral toxicity dose (LD50) for target chemical chromium(3+) ion hydrogen bis(1-(3-chlorophenyl)-4-[(E)-2-(5-methanesulfonyl-2-oxidophenyl)diazen-1-yl]-3-methyl-1H-pyrazol-5-olate)(CAS no: 71598-35-1) was predicted based on OECD QSAR toolbox, the value estimated to be 4200 mg/kg bw and different studies available on structurally similar read across substances 4,4'-(1E,1'E)-(3,3'-dichlorobiphenyl-4,4'-diyl)bis(diazene-2,1-diyl)bis(3-methyl-1-phenyl-1H-pyrazol-5(4H)-one) (CAS no: 3520-72-7), the LD50 was considered to be >5000 mg/kg bw and 4,4'-[(3,3'-dichlorobiphenyl-4,4'-diyl) didiazene-2,1-diyl]bis[5-methyl-2-(4-methylphenyl) -2,4-dihydro-3H-pyrazol-3-one] (CAS no: 15793-73-4), the LD50 was considered to be >16000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, chromium (3+) ion hydrogen bis(1-(3-chlorophenyl)-4-[(E)-2-(5-methanesulfonyl-2-oxidophenyl)diazen-1-yl]-3-methyl-1H-pyrazol-5-olate) cannot be classified for acute oral toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd32067f-2bd6-417d-affc-5a9a6083622e/documents/7be9f631-2b90-4b2c-a081-eac3fa8043ff_e29907be-b48e-4118-9050-69f3184caf22.html,,,,,, "Hydrogen bis[2-(3-chlorophenyl)-2,4-dihydro-4-[[2-hydroxy-5-mesylphenyl]azo]-5-methyl-3H-pyrazol-3-onato(2-)]chromate(1-)",71598-35-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd32067f-2bd6-417d-affc-5a9a6083622e/documents/7be9f631-2b90-4b2c-a081-eac3fa8043ff_e29907be-b48e-4118-9050-69f3184caf22.html,,oral,LD50,"4,200 mg/kg bw",no adverse effect observed, "Hydrogen bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-)",52256-37-8,LD50(oral) > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d335d31-1bea-4177-83cb-8c1596f6d082/documents/b98a0d72-eee5-486a-99b2-c24b3d86f360_10c2d194-f0e3-47b1-9793-94b71ecda641.html,,,,,, "Hydrogen bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-), compound with 2-ethylhexylamine (1:1)",71701-15-0,Most animals survived a dose of 15000 mg/kg via gavage with only minor effects. Only 1 male died ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6acd5ff0-66a3-4bd5-a012-30d5992e723c/documents/IUC5-9cc70e5c-dc7e-4181-8b11-fc09371b3b62_8bbbfbf9-0e88-4297-92e8-3f0efed8979a.html,,,,,, "Hydrogen bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-), compound with 2-ethylhexylamine (1:1)",71701-15-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6acd5ff0-66a3-4bd5-a012-30d5992e723c/documents/IUC5-9cc70e5c-dc7e-4181-8b11-fc09371b3b62_8bbbfbf9-0e88-4297-92e8-3f0efed8979a.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "Hydrogen bis[2-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-5-sulphamoylbenzoato(2-)]chromate(1-)",63910-74-7," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The LD50 value is >5000 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/452e9a08-4453-4b93-ad1f-73f853f15690/documents/889cbcd2-2dc9-4a77-9914-3d09d44f06ad_aa741283-1bd7-4a73-8407-4ad21c7e6267.html,,,,,, "Hydrogen bis[2-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-5-sulphamoylbenzoato(2-)]chromate(1-)",63910-74-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/452e9a08-4453-4b93-ad1f-73f853f15690/documents/889cbcd2-2dc9-4a77-9914-3d09d44f06ad_aa741283-1bd7-4a73-8407-4ad21c7e6267.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrogen bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzene-1-sulphonamidato(2-)]chromate(1-)",30112-70-0, LD50 > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71496c91-bb5c-4ea8-a671-0cb2f86f9b8f/documents/224c331e-f2d2-449d-8e5a-bcbe07dd0d31_11f609ac-f143-4280-9eb9-7b3f5213738d.html,,,,,, "Hydrogen bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzene-1-sulphonamidato(2-)]chromate(1-)",30112-70-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71496c91-bb5c-4ea8-a671-0cb2f86f9b8f/documents/224c331e-f2d2-449d-8e5a-bcbe07dd0d31_11f609ac-f143-4280-9eb9-7b3f5213738d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)]cobaltate(1-)",85959-75-7," Acute oral toxicity: Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)]cobaltate(1-) (CAS no.: 85959-75-7). The studies are as mentioned below: 1. Acute oral toxicity study was conducted in rats using test chemical at the dose concentration of 15000mg/kg bw. No Mortality was observed at dose 15000 mg/kg bw. Hence, LD50 value was considered to be >15000 mg/kg bw, when rats were treated with test chemical orally. 2. Acute oral toxicity study was conducted by using given test chemical in rats at the concentration of 16000 mg/kg bw. No Mortality was observed at dose16000 mg/kg bw. Hence, LD50 value was considered to be >16000 mg/kg bw, when rats were treated with test chemical via oral route. Thus, based on the above summarised studies, Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato (2-)]cobaltate(1-) (CAS no.: 85959-75-7) and it’s structurally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)]cobaltate(1-) (CAS no.: 85959-75-7) cannot be classified for acute oral toxicity. Hence, Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)]cobaltate(1-) is not toxic in the dose range >15000 - >16000 mg/Kg bw, for acute oral toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8120126-b50e-4fa5-83c2-b7dffc20c70e/documents/d381bfb8-5f0d-4b33-be70-da457bfa0de3_e8d721f3-2343-42ae-94c1-c812dbbee346.html,,,,,, "Hydrogen bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)]cobaltate(1-)",85959-75-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8120126-b50e-4fa5-83c2-b7dffc20c70e/documents/d381bfb8-5f0d-4b33-be70-da457bfa0de3_e8d721f3-2343-42ae-94c1-c812dbbee346.html,,oral,LD50,"16,000 mg/kg bw",no adverse effect observed, "Hydrogen hydroxy[2-hydroxy-3-[(2-hydroxy-3-nitrobenzylidene)amino]-5-nitrobenzenesulphonato(3-)]chromate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)",85455-32-9, The oral LD50 was clearly above 10000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4ddda72-0c85-445b-a50d-a8a03682d035/documents/706d1118-c6f5-444a-af5a-fcfc44a1cdfc_f32003f9-0e17-4140-b0a4-04365a6e9eb2.html,,,,,, "Hydrogen hydroxy[2-hydroxy-3-[(2-hydroxy-3-nitrobenzylidene)amino]-5-nitrobenzenesulphonato(3-)]chromate(1-), compound with 3-[(2-ethylhexyl)oxy]propylamine (1:1)",85455-32-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4ddda72-0c85-445b-a50d-a8a03682d035/documents/706d1118-c6f5-444a-af5a-fcfc44a1cdfc_f32003f9-0e17-4140-b0a4-04365a6e9eb2.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Hydrogen iodide,10034-85-2," The test item is a strong acid with pH of ca. 1. It is classified as skin corrosive, Cat. 1 and as eye damaging, Cat. 1. Therefore, a test on acute oral toxicity was not performed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c81d2e74-84c4-47c7-847b-394acf655013/documents/303a59ec-80bf-45ee-b154-61c9407bda6f_bd3ee455-d8a5-4f06-b157-860a592da690.html,,,,,, Hydrogen sulphide,7783-06-4,Subchronic Inhalation toxicity studies in laboratory animals (rat and mouse) have identified the olfactory nasal mucosa as the principal target site affected. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22f66182-dea8-4279-b3bb-237c231fee51/documents/9e9df631-df0e-49f8-a6d7-4386e6ec36ce_55b6d1f6-6cf1-405f-bba7-88a290078867.html,,,,,, Hydrogen sulphide,7783-06-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22f66182-dea8-4279-b3bb-237c231fee51/documents/9e9df631-df0e-49f8-a6d7-4386e6ec36ce_55b6d1f6-6cf1-405f-bba7-88a290078867.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,42 mg/m3,,other:rat and mouse Hydrogen sulphide,7783-06-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22f66182-dea8-4279-b3bb-237c231fee51/documents/9e9df631-df0e-49f8-a6d7-4386e6ec36ce_55b6d1f6-6cf1-405f-bba7-88a290078867.html,Repeated dose toxicity – local effects,inhalation,NOAEC,14 mg/m3,adverse effect observed,other:rat and mouse Hydrogen sulphide,7783-06-4," In two acute inhalation toxicity studies with rats the concentrations of H2S which led to the death of 50% of the animals (LC50) were 444 ppm (621 mg/m3) (Tansy et al., 1981) and 501 ppm (696 mg/m3) (Prior et al., 1988), respectively, after exposure for 4 hours. The LC50 decreases with the exposure duration from 587 ppm (816 mg/m3) at 2 hours to 501 (696 mg/m3) and 335 ppm (466 mg/m3) at 4 and 6 hours, respectively. All rats that died had pulmonary oedema (Prior et al., 1988). The same time-related toxicity was found with mice. The LC50 decreases with the exposure duration from 1160 ppm (1610 mg/m3) at 10 minutes to 800 ppm (1110 mg/m3) and 676 ppm (940 mg/m3) at 30 and 60 minutes, respectively (Zwart et al. 1990). These results can be compared with the effects seen after 60 min exposure to rats: LC50 712 ppm (990 mg/m³) (MacEwen and Vernot, 1972). With rats these authors found an LC50 of 712 ppm (990 mg/m³). So no relevant species specific effects were seen between rats and mice.In aqueous environment H2S and its salt NaHS dissolves easily and are immediately hydrolyzed and an pH-dependent equilibrium is established between S2-, HS- and H2S. As there is no acute oral and dermal toxicity study available with H2S the results of the studies with NaHS are taken to derive an oral and dermal LD50.An oral LD50 value has been calculated for H2S: 49 mg/kg bw. With NaHS no specific symptoms were observed. Fatalities occurred within one hour after administration.A dermal LD50 value has been calculated for H2S: 124 mg/kg bw. With NaHS the animals showed reddenig at the application site and unbalancing. Fatalities occured until 2 hours after application. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22f66182-dea8-4279-b3bb-237c231fee51/documents/280e9825-2557-4cc0-9d4b-af2ec8412389_55b6d1f6-6cf1-405f-bba7-88a290078867.html,,,,,, Hydrogen sulphide,7783-06-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22f66182-dea8-4279-b3bb-237c231fee51/documents/280e9825-2557-4cc0-9d4b-af2ec8412389_55b6d1f6-6cf1-405f-bba7-88a290078867.html,,oral,LD50,49 mg/kg bw,adverse effect observed, Hydrogen sulphide,7783-06-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22f66182-dea8-4279-b3bb-237c231fee51/documents/280e9825-2557-4cc0-9d4b-af2ec8412389_55b6d1f6-6cf1-405f-bba7-88a290078867.html,,dermal,LD50,124 mg/kg bw,adverse effect observed, Hydrogen sulphide,7783-06-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22f66182-dea8-4279-b3bb-237c231fee51/documents/280e9825-2557-4cc0-9d4b-af2ec8412389_55b6d1f6-6cf1-405f-bba7-88a290078867.html,,inhalation,LC50,621 mg/m3,adverse effect observed, "Hydrogen tetrasodium bis[2-[[6-[[4-chloro-6-[3-sulphoanilino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3-sulpho-2-naphthyl]azo]benzoato(4-)]chromate(5-)",73507-17-2," Acute oral toxicity: The acute oral median lethal dose (LD50) of the test chemical was >2000 mg/kg body weight. Thus, it can be concluded that the test chemical is likely to fall in category ""Not classified"" when administered by oral route of exposure, as per the criteria mentioned in CLP regulation. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15f0fa04-9b8f-42f6-908a-10a911975272/documents/0db767ec-9ee6-444d-83d1-a59ad5ceda95_ec728ec5-be4c-47d5-b543-409f8c35797e.html,,,,,, "Hydrogen tetrasodium bis[2-[[6-[[4-chloro-6-[3-sulphoanilino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3-sulpho-2-naphthyl]azo]benzoato(4-)]chromate(5-)",73507-17-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15f0fa04-9b8f-42f6-908a-10a911975272/documents/0db767ec-9ee6-444d-83d1-a59ad5ceda95_ec728ec5-be4c-47d5-b543-409f8c35797e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Hydrogen trifluoromethoxyborate(1-), compound with methanol (1:1)",2802-68-8," No study is available for the test substance itself. Therefore, repeated dose toxicity was assessed with the read across substances boron trifluoride, boron trifluoride dihydrate and methanol, which is considered acceptable in accordance with REACH Annex XI, section 1.5, as discussed in IUCLID chapter 7.1. Boron trifluoride, boron trifluoride dihydrate Several studies are available for that endpoint but only one subacute toxicity study and one subchronic toxicity study are of good quality. All studies point out that BF3 (gas) or BF3 dihydrate causes signs of respiratory distress, and two of them show that BF3 dihydrate may be responsible for kidney toxicity (necrosis of proximal tubular epithelium). This effect was observed in the two Rusch studies (subacute toxicity study and 90-day toxicity study) and is correlated with increase of fluorine amounts in urine and in serum that were not considered as adverse but that are related to kidney effects. The kidney effects in the subchronic toxicity study were not significant as it was observed in only 2 rats of the highest dose group. In the subacute toxicity study, all rats of the highest dose group developed necrosis of proximal tubular epithelium. But the histopathological examinations were limited by autolytic changes resulting from the spontaneous deaths of these animals.   Key study (Rusch et al., 1986; boron trifluoride dihydrate) The potential toxicity of boron trifluoride (BF3) was evaluated following repeated inhalation administration for 13 weeks, according to OECD Guideline 413. The substance was tested in a dihydrate form which contained 63.87% of BF3. Aerosols of BF3 dihydrate were administered daily by inhalation to Fischer 344 rats (20 males and 20 females), 6 hrs/day, 5 days a week, at the dose-levels of 0, 2, 6, 17 mg/m3 during 90 days. Body weights were recorded pre-test, weekly and at death or prior necropsy. Animals were observed daily for toxicity and pharmacological effects, and twice daily for morbidity and mortality. Whole blood, serum and plasma, and urine were sampled after one month of exposure in 5 animals/sex/dose, during the final week of the exposure period (15 animals/sex/dose) and in the retained animals (5/sex/dose) at the end of the post-exposure period. In addition, fluoride was measured in urine and in blood after 1 and 2 months of exposure and 2 weeks after the final exposure. All animals were examined for gross pathology, and organs were weighted and submitted to histopathology. Tissues from 40 major organs of high-exposure and control groups were examined. In addition, nasal turbinates, kidneys, lungs and liver were examined from all other animals of the study. At 17 mg/m3, one death was attributed to the test substance. No differences were observed between treated and control groups for body weight and haematology. Urine analysis and blood chemistry were affected by treatment. Clinical signs of respiratory irritation were seen, but without abnormal histological findings. An exposure-related depression of total protein concentrations accompanied by an exposure-related depression of globulin concentrations was observed. In urines, an exposure-related depression in calcium amounts and an exposure-related increase in urinary fluoride were noted. The decrease in calcium values was found to be reversible at the end of exposure, contrary to the decrease of urinary fluoride which was partially reversible. Serum fluoride concentrations were markedly increased in all exposure groups (dose-related increase). A recovery was noted after the end of exposure. At necropsy, no differences for organ weight and macroscopic appearance were observed between treated and control groups. At microscopy examination, necrosis of the renal tubular epithelium was seen in the highest dose group and was the apparent cause of a death in one of the animals. Consequently, under the experimental conditions, the No Observed Adverse Effect Level (NOAEL) is 6 mg/m3 and the LOAEL is 17 mg/m3 for effects on kidney. The increase of fluorine amounts in serum and in urine are not considered as adverse since no signs of toxicity were associated and since it was reversible or partially reversible (as the recovery period was only 2 week, a full reversibility was not observed for urinary fluorine); nevertheless they are related to treatment.   Supporting study (Rusch et al. 1986; boron trifluoride dihydrate) The potential toxicity of BF3 dihydrate was evaluated following repeated inhalation administration for 2 weeks, according to OECD Guideline 412. BF3 dihydrate was administered once daily by inhalation to aerosols to Fischer 344 rats (5 Males and 5 Females), at the dose-levels of 0, 24, 66 and 180 mg/m3, 6 hours a day, for 2 weeks (5 days the first week and only 4 days the second week). All rats of the highest dose group died prior to the 6th exposure. No mortality occurred in the other dose groups but the animals elicited signs of respiratory distress and irritation. Mean body weight was decreased at 66 mg/m3. Lung weight was increased in all dose groups. The histopathological findings revealed a necrosis and pyknosis of the proximal tubular epithelium in the kidneys of the high exposure group rats. Nevertheless, the histopathological examinations were limited by autolytic changes resulting from the spontaneous deaths of these animals. The NOAEL for systemic effects was 66 mg/m3 (tubular necrosis of the kidney). No NOAEL for respiratory distress was determined since it was observed at all dose levels tested.   Supporting study (Torkelson et al. 1961; boron trifluoride) The Torkelson study is a 6 -months toxicity study where rats were exposed to about 2.8 mg/m3, 8.2 mg/m3 or 11.9 mg/m3 of BF3 (gas). The major observed effect was respiratory irritation. Toxicity also involved pneumotitis and dental fluorosis. This study was questionable because of methodological deficiencies, e.g. BF3 was directly instilled into the exposure chambers in order to avoid formation of aerosols of BF3-hydrates. Air humidity was kept down to 30 % which is unusually low. Even the glass was corroded by this rather artificial procedure. The Rusch study (see key study) appears to be more appropriate and relevant, regarding both experimental generation of BF3 or BF3 dihydrate (BF3 dihydrate aerosols were formed and administered in the Rusch study into an atmosphere with 60 % humidity) and general experimental study design. Nevertheless, respiratory irritation observations are coherent with those of Rusch publications.     Methanol Animal data Oral: Seven male monkeys received daily doses of 2340 mg/kg bw methanol as 30% aqueous solution by oral gavage for three days. Under the test conditions, this dosage was lethal for all seven animals (Rao et al., 1977). Inhalation: In a whole-body inhalation study in monkeys exposed to 0.013, 0.13, and 1.3 mg/L for 21 hours/day, 7 days/week for 7, 19, and 29 months, several general clinical signs as well as degenerative effects in the brain (at 0.13 and 1.3 mg/L), slight peripheral nerve damage (at 0.13 and 1.3 mg/L), very slight degeneration of the optic nerve (concentrations not noted), increased fat granules and slight fibrosis in the liver (all concentrations) as well as Sudan positive granules in the kidney were observed (at 0.13 and 1.3 mg/L). Also, a slight myocardial disorder (at 0.13 and 1.3 mg/L) and localized effects in the trachea and possible slight fibrosis in the lungs (concentrations not noted) were observed. Although the statistical significance of the effects cannot be verified from the limited study report, the effects observed appear to be associated with methanol (NEDO, 1987). In a short-time experiment, monkeys were exposed up to 20 days for 21 hours per day to methanol vapour. Coma and lethality were observed at concentrations > 9.31 mg/(L*d). In the brain, necrosis of the basal ganglia and cerebral edema were observed at 6.65 mg/(L*d) and at 3.99 mg/(L*d), hyperplasia and fibrosis around myelin sheaths of the basal ganglia as well as a slight to moderate increase in astroglia cells were observed. The optic nerve showed atrophy at > 3.99 mg/(L*d), along with reduction in myelin fibers. In the liver, fibrosis was observed at 6.65 mg/(L*d) and mild fatty degeneration was observed at 3.99 mg/(L*d). In the kidney, partly vacuolated hyaline degeneration was observed at 6.65 mg/(L*d) (NEDO, 1987). The liver and kidney effects were recorded at doses already overtly toxic in humans and, hence, are of low relevance. In rats exposed to methanol up to 6.65 mg/L for 6 hours per day, five days per week for 28 days, no adverse effects were observed except local nasal irritation and increased relative spleen weights, which were observed only at the middle dose. The estimated blood level of methanol was about 250 mg/L under this condition (Andrews et al., 1987). In a whole-body inhalation study in mice exposed for 12 months to concentrations of 0.013, 0.13, and 1.3 mg/L for 20 hours/day, slight changes in clinical signs, body and organ weights, and some changes in histopathology were observed, but these effects were considered to be toxicologically irrelevant (NEDO, 1987). In rats exposed in the same manner, slight changes in body weight and organ weights were observed at the highest dose. The NOEC was 0.13 mg/L, the NOAEC was 1.3 mg/L for rats and mice in these studies (NEDO, 1987). Again, these effects are of low relevance in the light of the onset of human toxicity already at lower doses. The species-related differences are very obvious between rodents and primates. The latter demonstrating a 100-fold greater susceptibility for methanol-related effects due to differences in metabolism of methanol. In rodents methanol is metabolized to carbon dioxide to a great extent, whereas in primates formate accumulation is responsible for the observed effects. Human data: In male and female workers exposed to methanol from 0.3 to 7.8 years, the highly exposed workers (4.7 - 7.3 mg/L) more often complained of blurred vision, headache and nasal irritation during or after work. Nobody stated to suffer from photophobia. The examination of the eye fundus failed to reveal retinal changes. Among three workers exposed to about 1.0 to 1.6 mg/L and one worker exposed to 0.12 to 3.6 mg/L, two showed retarded pupil reflex and one exhibited mild mydriasis (Kawai et al., 1991). Other common complaints were forgetfulness and skin sensitivity (IPCS/WHO, 1997). A health hazard evaluation was conducted by the National Institute for Occupational Safety and Health (NIOSH) to determine if vapours from duplicating fluid (99% methyl alcohol) used in direct-process spirit duplicating machines were causing adverse health effects among teacher aides (Frederick et al., 1984). The teacher aides reported significantly more blurred vision, headache, dizziness, and nausea than the comparison group. Concentrations of airborne methyl alcohol ranged from 0.48 to 4.0 mg/L. Additional studies also showed that headaches were associated with occupations that involve the operation of duplicating machines (NTP, 2003; IPCS/WHO, 1997). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b91a2074-6e13-4c75-81cc-a0a77b9d66d9/documents/2fc11851-b4b2-4bd8-8077-79b5089af784_5331a542-0f5e-4a12-895c-142f725bb367.html,,,,,, "Hydrogen trifluoromethoxyborate(1-), compound with methanol (1:1)",2802-68-8," Acute oral toxicity: In a GLP-compliant acute oral toxicity study performed according to EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method) (BASF, 1995), the substance was administered to rats via gavage in olive oil at doses of 200 and 2000 mg/kg. No mortality was observed at 200 mg/kg, whereas all animals in the 2000 mg/kg group died within 3 hours after administration. Clinical signs included impaired general state and dyspnea at 200 mg/kg and poor general state, dyspnea, apathy, staggering ataxia, paresis and cyanosis at 2000 mg/kg. The animals in the 2000 mg/kg group showed hemorrhages in the mucosa of the glandular stomach and substance discoloration of contents in the small intestines. No experimental data on acute inhalation or acute dermal toxicity with the complex of  boron trifluoride with methanol are available.  Boron trifluoride is classified as skin and eye corrosive and consequently the complex can also be regarded as corrosive, which was confirmed in a Skin corrosion study in rabbits according to OECD Guideline 404 (see IUCLID section 7.3.1). The following studies (read-across) conducted with boron trifluoride, boron trifluoride dihydrate and methanol further underline the acute toxicity /  corrosiveness of the complex. Acute inhalation toxicity: -Key / Read across to  boron trifluoride dihydrate: In a publication of Rusch et al. from 1986, groups (5/sex) of Fischer 344 rats (approx. 7 weeks old) were treated whole body via inhalation route with the read across substance boron trifluoride dihydrate (CAS No. 13319-75-0). Animals were exposed for 4 hours at concentrations of 1.01, 1.22, 1.32 and 1.54 mg/L. Animals were then observed for 14 days. All animals were examined at the end of the chamber equilibration period, at 0.25, 0.5, 0.75 and 1h during exposure, at 0, 1, 2 and 24 h post exposure and daily during the 14-day post-exposure observation period. Body weights were recorded on days 1, 2, 4, 7 and 14. Necropsy was performed on all animals. Mortality was observed in all dosing groups: 3/10 (1.01 mg/L), 2/10 (1.22 mg/L), 8/10 (1.32 mg/L) and 9/10 (1.54 mg/L). Observed clinical signs included dry and moist rales, gasping, excessive oral and nasal discharge, and lacrimation, indicative of respiratory distress and irritation. Recovery was apparent for the rats surviving beyond study day 6 post exposure. The LC50 (4 h) was calculated to be around 1210 mg/m3 when rats were whole body exposed by inhalation to aerosols of BF3 dihydrate. -Supporting / Read across to boron trifluoride and boron trifluoride dihydrate: The acute inhalation toxicity of the read across substance boron trifluoride dihydrate (CAS No. 13319-75-0) was evaluated in a 4-hour, single-exposure study in rats according to a protocol comparable to the OECD Guideline 403 (Rusch et al., 2008). The test substance was initially administered to a single group of ten male and ten female Sprague Dawley rats via whole-body exposure at concentrations of 0, 10, 30, 100 mg/m3 (nominal) (8.53±2.83, 24.6±10.3 and 74.4±11.9 mg/m3 (analytical)). All animals were examined at the end of the chamber equilibration period, at 0.25, 0.5, and 1h during exposure, at 0, 1, 2 and 24 h post exposure and twice daily during the 14-day post-exposure observation period for those animals not sacrificed 24 h post exposure. Body weights were recorded daily from pretreatment until sacrifice. There were no unscheduled deaths. There were no effects on body weight or body weight gain. The larynx showed treatment-related histopathological findings in rats in the 74.4-mg/m3 exposure level group. Based on the results of this study, the LC50 of BF3 was higher than 74.4+/-11.9 mg/m3 when male and female rats were exposed for a single, 4-hour period. Quite similar LC50 ranges were reported in other publications: LC50 (4 h) of 1180 mg/m3 (Kasparov et al. 1972) and LC50 (1 h) of 899.34 -1439.56 mg/m3 (Vernot et al. 1977), indicating that the substance has a high potential of acute toxicity by inhalation. The NOAEL for respiratory irritation following a single exposure of 4 hours to low dose levels was estimated around 24.6 mg/m3 (Rusch et al., 2008). - Supporting / Read across to methanol: The 4-hour LC50 of the read across substance methanol (CAS no. 67 -56 -1) in rats (via nose/head exposure) was calculated to be 128.2 mg/L (BASF, 1980b). For a 6 -hour exposure under the otherwise same conditions was calculated to be 87.5 mg/L. Clinical signs of toxicity were aqueous secretion of eyes and nose, labored breathing, staggering, apathy, and narcosis. A similar range of toxicity values is reported for the mouse: LC50 (2.25 h) = approx. 79 mg/L (Von Burg, 1994). In cats, a LC50 value of approx. 43.7 mg/L was obtained after a 6-hour exposure (Von Burg, 1994). A shorter duration of 4.5 hours led to a LC50 value of 85.4 mg/L (Von Burg, 1994). Studies in Rhesus monkeys indicate lethal concentrations (% mortality not reported) of 1.3 mg/L (after 41 hours), 13 mg/L (after 18 hours) and 52 mg/L methanol (after 1–4 hours). Blindness associated with optic nerve atrophy was reported. Eventual recovery from this lesion was observed (McCord, 1931; only limited documentation). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b91a2074-6e13-4c75-81cc-a0a77b9d66d9/documents/da2633c3-db64-4301-a503-e46aea0250d9_5331a542-0f5e-4a12-895c-142f725bb367.html,,,,,, Hydroxy(2-methylprop-2-enoato-O)zinc,63451-47-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13a9baee-a253-4a99-a8eb-a5a04634a0bd/documents/IUC5-242d2e97-ca60-4096-8de0-b39cc08f5640_72be1323-c2af-406d-9d1e-f2bee1aea882.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,53.5 mg/kg bw/day,,rat Hydroxy(2-methylprop-2-enoato-O)zinc,63451-47-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13a9baee-a253-4a99-a8eb-a5a04634a0bd/documents/IUC5-242d2e97-ca60-4096-8de0-b39cc08f5640_72be1323-c2af-406d-9d1e-f2bee1aea882.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,357 mg/m3,,rat Hydroxy(2-methylprop-2-enoato-O)zinc,63451-47-8,- Hydroxy(2-methylprop-2-enoato-O)zinc: LD50 > 2000 mg/kg bw in rats- Zinc methacrylate: LC50 > 5.32 mg/L for 4 hr in rats ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13a9baee-a253-4a99-a8eb-a5a04634a0bd/documents/IUC5-8c46bb1c-d959-4f58-bdd0-13c79922ed5a_72be1323-c2af-406d-9d1e-f2bee1aea882.html,,,,,, Hydroxy(2-methylprop-2-enoato-O)zinc,63451-47-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13a9baee-a253-4a99-a8eb-a5a04634a0bd/documents/IUC5-8c46bb1c-d959-4f58-bdd0-13c79922ed5a_72be1323-c2af-406d-9d1e-f2bee1aea882.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Hydroxy(2-methylprop-2-enoato-O)zinc,63451-47-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13a9baee-a253-4a99-a8eb-a5a04634a0bd/documents/IUC5-8c46bb1c-d959-4f58-bdd0-13c79922ed5a_72be1323-c2af-406d-9d1e-f2bee1aea882.html,,inhalation,LC50,"5,320 mg/m3",no adverse effect observed, Hydroxyacetone,116-09-6," Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test with Hydroxyacetone in Wistar Rats according to OECD 422 and GLP; m/f, 42 resp. 51-57 days, gavage; NOAEL = 1000 mg/kg ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1eaaa421-2875-4bc0-9dd6-65adedf12bb9/documents/9ec43bcc-030d-481f-88d3-d8ad895b2144_18628472-1bea-4bc0-8439-9236ddd23cac.html,,,,,, Hydroxyacetone,116-09-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1eaaa421-2875-4bc0-9dd6-65adedf12bb9/documents/9ec43bcc-030d-481f-88d3-d8ad895b2144_18628472-1bea-4bc0-8439-9236ddd23cac.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Hydroxyacetone,116-09-6," Rat, OECD Guideline 423 (Class method), result: LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1eaaa421-2875-4bc0-9dd6-65adedf12bb9/documents/6deb2a78-6922-4fd1-9bda-1552b189afe4_18628472-1bea-4bc0-8439-9236ddd23cac.html,,,,,, Hydroxyacetone,116-09-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1eaaa421-2875-4bc0-9dd6-65adedf12bb9/documents/6deb2a78-6922-4fd1-9bda-1552b189afe4_18628472-1bea-4bc0-8439-9236ddd23cac.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Hydroxylamine-O-sulphonic acid,2950-43-8,"Oral LD50 (rat): > 300 - < 500 mg/kg bw (BASF 2010, according to OECD 423) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0306b9b-cc8f-44e1-86c2-cbd6bfabbb1c/documents/IUC5-1963f7ce-52f1-4ee4-9de5-14e771fb9278_b6d330e2-b996-4c8c-97ac-897e5d6c5a5a.html,,,,,, Hydroxytrimethylsilane,1066-40-6,"In an inhalation OECD Test Guideline 422 screening study (WIL Research Laboratories, 2008, reliability score 1), which was conducted in compliance with GLP, the NOAEC for trimethylsilanol was ≥600 ppm (2213.5 mg/m3).   In a 28-day oral repeated dose toxicity study (Bayer AG, 1986b, reliability score 2) conducted to OECD Test Guideline 407 and in compliance with GLP, the NOAEL for trimethylsilanol was 250 mg/kg bw/day.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/478a8128-d878-4204-8a2e-eec418ffd8dc/documents/5b51c905-0075-41bb-a75e-53bead4749c9_085d40ce-3d9f-4c4f-899e-12a788998e18.html,,,,,, Hydroxytrimethylsilane,1066-40-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/478a8128-d878-4204-8a2e-eec418ffd8dc/documents/5b51c905-0075-41bb-a75e-53bead4749c9_085d40ce-3d9f-4c4f-899e-12a788998e18.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Hydroxytrimethylsilane,1066-40-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/478a8128-d878-4204-8a2e-eec418ffd8dc/documents/5b51c905-0075-41bb-a75e-53bead4749c9_085d40ce-3d9f-4c4f-899e-12a788998e18.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"2,213.5 mg/m3",,rat Hydroxytrimethylsilane,1066-40-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/478a8128-d878-4204-8a2e-eec418ffd8dc/documents/5b51c905-0075-41bb-a75e-53bead4749c9_085d40ce-3d9f-4c4f-899e-12a788998e18.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"2,213.5 mg/m3",no adverse effect observed,rat Hydroxytrimethylsilane,1066-40-6,"In an acute oral toxicity study conducted using a protocol comparable to the now deleted OECD Test Guideline 401, but not in compliance with GLP (Bayer, 1985a, reliability score 2), the LD50 for trimethylsilanol (CAS 1066-40-6; EC 213-914-1) was 3.5 ml/kg bw (2835 mg/kg bw based on a density of 0.81 g/cm3) in rats.   In an acute inhalation study conducted to OECD Test Guideline 403 and in compliance with GLP (WIL, 2007, reliability score 1), the 4 hour LC50 of trimethylsilanol was 3151 ppm (11.8 mg/l) in rats. There are no acute dermal toxicity studies for trimethylsilanol.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/478a8128-d878-4204-8a2e-eec418ffd8dc/documents/0ce0a0cf-e2ef-44c0-bb5b-08b203a435ee_085d40ce-3d9f-4c4f-899e-12a788998e18.html,,,,,, Hydroxytrimethylsilane,1066-40-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/478a8128-d878-4204-8a2e-eec418ffd8dc/documents/0ce0a0cf-e2ef-44c0-bb5b-08b203a435ee_085d40ce-3d9f-4c4f-899e-12a788998e18.html,,oral,LD50,"2,835 mg/kg bw",adverse effect observed, Hydroxytrimethylsilane,1066-40-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/478a8128-d878-4204-8a2e-eec418ffd8dc/documents/0ce0a0cf-e2ef-44c0-bb5b-08b203a435ee_085d40ce-3d9f-4c4f-899e-12a788998e18.html,,inhalation,LC50,"11,800 mg/m3",adverse effect observed, Icosyl acrylate,48076-38-6,"Oral  In two combined repeated oral dose and reproductive / developmental toxicity screening studies (OECD 422) in rats the structural analogues 2-Propenoic acid, C12-14-alkyl esters and 2-Propenoic acid, C18-22-alkyl esters showed no toxicity up to the highest administered dose of 1000 mg/kg bw/day (see table 1).  Table 1. Data on repeated oral dose toxicity     Ester   Method   Species   NOAEL   Reference 2-Propenoic acid, C12-14- alkyl esters     OECD TG 422   Rats   1000 mg/kg bw/day (highest dose tested)   BASF SE 2013 2-Propenoic acid, C18-22- alkyl esters     OECD TG 422   Rats   1000 mg/kg bw/day (highest dose tested) BASF SE 2013 The available data from the group of long-chain acrylate esters for repeated dose toxicity cover the shortest and longest chain lengths present in the category. Within both studies the NOAEL was 1000 mg/kg bw/d the highest dose tested and the limit dose for this kind of study.  The long-chain alky acrylates have a decreasing bioavailability with increasing chain length. As described in the chapter 7.1. Toxicokinetics in silico and in vitro studies were performed to address this.  A PBPK model using The Simcyp Animal Simulator Version 22 Release 1 (Certara UK, Hartley, 2023)) was used for PBPK simulations of ethyl acrylate, 2-ethylhexyl acrylate, dodecyl acrylate, tetradecyl acrylate, hexadecyl acrylate, octadecyl acrylate, Icosyl acrylate and docosyl acrylate. A whole body PBPK model, which allows for the addition of further specific organs, or a minimal PBPK model was used in simulations. The expected low gastrointestinal and systemic uptake was confirmed in this in silico PBPK modelling. For dodecyl acrylate, tetradecyl acrylate, hexadecyl acrylate, octadecyl acrylate; icosyl acrylate and docosyl acrylate the predicted fraction absorbed was 0.81, 0.71, 0.015, 0.0001, 0.0022, and 0.0006, respectively. In addition, an in vitro intestinal absorption test with acrylates in the EpiIntestinal model was performed with dodecyl acrylate, hexadecyl acrylate, octadecyl acrylate and docosyl acrylate (BASF SE, 2024). The results of this in vitro intestinal absorption test (EpiIntestinal model) indicate that none of the four compounds (dodecyl acrylate , hexadecyl acrylate, octadecyl acrylate and docosyl acrylate) crosses the intestinal barrier. Based on the results regarding the hydrolysis and metabolism of the compounds to the corresponding alcohols, we identified a considerable transfer of 1-dodecanol (6.3%) and a marginal transfer of 1-hexadecanol (0.4%) to the receptor chamber, indicating that hydrolysis products of short chain acrylates might cross the intestinal barrier. In the in vitro intestinal absorption test the concentration of dodecyl acrylate of 5 mM (limited by cytotoxicity in higher concentrations) equates to a dose of 509.6 mg/kg BW, the concentration of hexadecyl acrylate, octadecyl acrylate and docosyl acrylate of 100 mM equates to doses of 12572, 13760 and 16140 mg/kg BW, respectively, which markedly exceeds the in vivo limit dose of 1000 mg/kg BW (repeated dose toxicity / reproduction toxicity). Taken together, it can be postulate that under realistic exposure scenarios no physiologically relevant uptake of the long-chain alkyl acrylates occurs. Based on this data it can be expected that dodecyl acrylate, the category member with the shortest alkyl chain has a low likelihood to be bioavailable after oral uptake. Whereas for the other category members the bioavailiability after oral uptake can be regarded to be negligible. Therefore, the registrant proposes to perform a subchronic study, according to OECD TG 408 with dodedyl acrylate to support the data requirements according to REACH Annex IX. In addition, a repeated oral dose and reproductive / developmental toxicity screening studies according to OECD TG 422 is ongoing with hexadecyl acrylate to support the hypothesis.   Inhalation  The inhalation route is not of relevance due to the very low vapour pressure of the substances (see chapter on Toxicokinetics).  Dermal  The experimental repeated dose oral toxicity data demonstrated in accordance with acute dermal and oral tests the low toxicity of the long-chain alkyl esters. In addition, the characteristics of skin penetration and metabolism in the skin show the limited bioavailability of the esters via the dermal route (see chapter on Toxicokinetics). Therefore, the potential for repeated dermal dose toxicity can be considered low.  Conclusion  In conclusion, the long-chain alkyl acrylate esters (C12 – C22) showed no oral toxicity after repeated application. Studies available are considered to be reliable and suitable to cover the endpoint repeated dose toxicity and fulfil the REACH information requirements of Annex VIII / IX, section 8.6.  The variable part of the category approach is the length and/or configuration of the side chain of the parent ester and the alcohol metabolite, as well as their impacts on physico-chemical properties and consequent biological properties. Despite these variations, the available data support a lack of systemic toxicity for all the category members, since data is availablefor the shortest and longest chain lengths present in the category. These repeated dose toxicity studies have also reported a similar and common profile of target organs (i.e. a lack of systemic toxicity). Thus, the results of the collection of these studies conducted on these substances are consistent and can be regarded as offering a true picture of repeated dose toxicity for the category. In order to fill the data-gap for the mono-constituents, a category based read-across is applied to the repeated dose toxicity studies available for oral route. Overall, the read-across approach is applied with a high level of confidence.    Therefore, the registrant proposes to perform a subchronic study, according to OECD TG 408 with dodedyl acrylate to support the data requirements according to REACH Annex IX. In addition, a repeated oral dose and reproductive / developmental toxicity screening studies according to OECD TG 422 is ongoing with hexadecyl acrylate to support the hypothesis of negligible bioavailability. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2279c4d2-f876-42b2-923d-a80cdd8099d4/documents/889efad2-1caf-427c-bb99-7a157b56af99_da07cec0-14c0-485a-9320-210567cccca6.html,,,,,, Icosyl acrylate,48076-38-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2279c4d2-f876-42b2-923d-a80cdd8099d4/documents/889efad2-1caf-427c-bb99-7a157b56af99_da07cec0-14c0-485a-9320-210567cccca6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Icosyl acrylate,48076-38-6,"Three oral toxicity studies conducted with mixtures of long-chain acrylate esters and one study with octadecyl acrylate (C18) showed no acute toxicity after oral exposure (see table 1).   Table 1 . Acute oral toxicity data from the source substances    Ester   Method   Species   LD50   Reference 2-Propenoic acid, C16-18-alkyl esters     OECD TG 423   Rats   > 2000 mg/kg bw   BASF SE 2012 Octadecyl acrylate   EU B.1 Rats > 5000 mg/kg bw BASF SE 1985 2-Propenoic acid, C18-22-alkyl esters     OECD TG 423   Rats   > 2000 mg/kg bw   BASF SE 2012 2-Propenoic acid, C12-14-alkyl esters   OECD TG 401 Rats > 5570 mg/kg bw BASF AG 1964 The available data from the group of long-chain acrylate esters for the oral route cover all chain lengths present in the category. They are consistent and sufficient to enable an assessment for this endpoint.  Inhalation  The inhalation route is not of relevance due to the low vapour pressure of the substances (see chapter on Toxicokinetics).  Dermal  Three dermal toxicity studies conducted with mixtures of long-chain acrylate esters showed no acute toxicity after dermal application (see table 2 ).  Table 2 . Acute dermal toxicity data from the source substances  Ester Method Species LD50 Reference 2-Propenoic acid, C12-14-alkyl esters   OECD TG 402 Rat > 5000 mg/kg bw BASF SE 2012 2-Propenoic acid, C16-18-alkyl esters       OECD TG 402     Rat     > 5000 mg/kg bw     BASF SE 2012 2-Propenoic acid, C18-22-alkyl esters   OECD TG 402 Rat > 5000 mg/kg bw BASF SE 2012 The available data from the group of long-chain acrylate esters for the dermal route cover all chain lengths present in the category. They are consistent and sufficient to enable an assessment for this endpoint.    ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2279c4d2-f876-42b2-923d-a80cdd8099d4/documents/667a918b-7327-4b68-8111-25e0d1670fe6_da07cec0-14c0-485a-9320-210567cccca6.html,,,,,, Icosyl acrylate,48076-38-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2279c4d2-f876-42b2-923d-a80cdd8099d4/documents/667a918b-7327-4b68-8111-25e0d1670fe6_da07cec0-14c0-485a-9320-210567cccca6.html,,oral,discriminating dose,"5,570 mg/kg bw",no adverse effect observed, Icosyl acrylate,48076-38-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2279c4d2-f876-42b2-923d-a80cdd8099d4/documents/667a918b-7327-4b68-8111-25e0d1670fe6_da07cec0-14c0-485a-9320-210567cccca6.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Icosyl acrylate,48076-38-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2279c4d2-f876-42b2-923d-a80cdd8099d4/documents/667a918b-7327-4b68-8111-25e0d1670fe6_da07cec0-14c0-485a-9320-210567cccca6.html,,inhalation,discriminating conc.,690 mg/m3,no adverse effect observed, Icosyl methacrylate,45294-18-6,"Subacute study; oral (gavage); rat (Sprague Dawley SD), m/f (OECD guideline 422, Klimisch score: 1,GLP), no toxicity occurred up to the highest administered dose of 1000 mg/kg/day with the structural analogue dodecyl methacrylate: NOAEL = 1000 mg/kg bw/d (CIT, 2007).With regard to the low repeated dose oral toxicity and the characteristics of skin penetration and metabolism in the skin, the repeated dose dermal toxicity can be considered as low. The inhalation route is not of relevance due to the very low vapour pressure of the substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a75eba2d-4f84-4802-a150-9f2bee843309/documents/IUC5-3a6be993-f93d-4d97-bf40-2df4fa9f8558_54b2ca51-eee2-4f06-909d-6be831adf135.html,,,,,, Icosyl methacrylate,45294-18-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a75eba2d-4f84-4802-a150-9f2bee843309/documents/IUC5-3a6be993-f93d-4d97-bf40-2df4fa9f8558_54b2ca51-eee2-4f06-909d-6be831adf135.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Icosyl methacrylate,45294-18-6,"The acute toxicity of eicosyl methacrylate ester can be considered as very low as the acute toxicity of the structural analogue substance dodecyl methacrylate by the oral route was determined to be (LD50: > 5000 mg/kg, oral, rat, OECD 401, GLP, Klimisch score: 1) and dermal route (LD50: > 3000 mg/kg, Structurally related substance isodecyl methacrylate, dermal, rabbit, Klimisch score: 2). This experimentally observed result is supported by a dermal toxicity study with structural analogue dodecyl pentadecyl methacrylate where a LD50: > 5000 mg/kg, dermal, rabbit was observed. The inhalation route is not of relevance due to the very low vapour pressure (0.0064 hPa at 25 °C) of the structural analogue substance dodecyl methacrylate. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a75eba2d-4f84-4802-a150-9f2bee843309/documents/IUC5-238480cd-5ced-457e-9301-a80d6557a974_54b2ca51-eee2-4f06-909d-6be831adf135.html,,,,,, Icosyl methacrylate,45294-18-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a75eba2d-4f84-4802-a150-9f2bee843309/documents/IUC5-238480cd-5ced-457e-9301-a80d6557a974_54b2ca51-eee2-4f06-909d-6be831adf135.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Icosyl methacrylate,45294-18-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a75eba2d-4f84-4802-a150-9f2bee843309/documents/IUC5-238480cd-5ced-457e-9301-a80d6557a974_54b2ca51-eee2-4f06-909d-6be831adf135.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, imidacloprid (ISO); 1-(6-chloropyridin-3-ylmethyl)-N-nitroimidazolidin-2-ylidenamine,138261-41-3," Oral administration key; M-007967-01-1; subchronic (96 days, rat): NOAEL (oral) 14.0 mg/kg bw/day (males) and 83.3 mg/kg bw/day (females) key; M-027741-02-1; chronic (2 years, rat): NOAEL (oral) 5.7 mg/kg bw/day (males) and 24.9 mg/kg bw/day (females) key; M-026540-01-1; subchronic (90 days, dog): NOAEL (oral) 23.0 mg/kg bw/day (combined values for both sexes, re-calculated based on body weights and feed consumption) key; M-027093-01-1; chronic (52 weeks, dog): NOAEL (oral) 15 mg/kg bw/day (males, females)   Inhalative administration key; M-026004-01-1; subacute (4 weeks, rat): NOAEC (inhalation) 5.5 mg/m³ air (males, females)   Dermal administration key; M-025976-01-1; subacute (4 weeks, rabbit): NOAEL (dermal) 1000 mg/kg bw/day (males, females) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55653e15-12ad-485a-a5f8-2510df6cd8c5/documents/4b2a379c-f8e4-487a-ba3e-2af456e17522_96e57677-6195-4e81-b042-a6cfc70e055f.html,,,,,, imidacloprid (ISO); 1-(6-chloropyridin-3-ylmethyl)-N-nitroimidazolidin-2-ylidenamine,138261-41-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55653e15-12ad-485a-a5f8-2510df6cd8c5/documents/4b2a379c-f8e4-487a-ba3e-2af456e17522_96e57677-6195-4e81-b042-a6cfc70e055f.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,5.5 mg/m3,,rat imidacloprid (ISO); 1-(6-chloropyridin-3-ylmethyl)-N-nitroimidazolidin-2-ylidenamine,138261-41-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55653e15-12ad-485a-a5f8-2510df6cd8c5/documents/4b2a379c-f8e4-487a-ba3e-2af456e17522_96e57677-6195-4e81-b042-a6cfc70e055f.html,Chronic toxicity – systemic effects,oral,NOAEL,5.7 mg/kg bw/day,,rat imidacloprid (ISO); 1-(6-chloropyridin-3-ylmethyl)-N-nitroimidazolidin-2-ylidenamine,138261-41-3," WoE, M-028854 -01 -1: Oral (OECD 401), rat: LD50: 642 mg/kg bw (males) and 648 mg/kg bw (females) WoE, M-025996 -01 -1: Oral (OECD 401), rat: LD50: 424 mg/kg bw (males) and in the range of 450 to 475 mg/kg bw (females) WoE, M-028901 -1: Oral (OECD 401), rat: LD50: 504 mg/kg bw (males) and 379 mg/kg bw (females) WoE, M-007509 -01 -1: Oral (OECD 401), mouse: LD50: 131 mg/kg bw (males) and 168 mg/kg bw (females)   Inhalation (OECD 403), rat: LC50 (dust): 5.32 mg/L air (males and females) Dermal (OECD 402), rat: LD50 > 5000 mg/kg bw (males and females) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55653e15-12ad-485a-a5f8-2510df6cd8c5/documents/657ba275-b020-47bc-b586-42a03795c085_96e57677-6195-4e81-b042-a6cfc70e055f.html,,,,,, imidacloprid (ISO); 1-(6-chloropyridin-3-ylmethyl)-N-nitroimidazolidin-2-ylidenamine,138261-41-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55653e15-12ad-485a-a5f8-2510df6cd8c5/documents/657ba275-b020-47bc-b586-42a03795c085_96e57677-6195-4e81-b042-a6cfc70e055f.html,,oral,LD50,131 mg/kg bw,adverse effect observed, imidacloprid (ISO); 1-(6-chloropyridin-3-ylmethyl)-N-nitroimidazolidin-2-ylidenamine,138261-41-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55653e15-12ad-485a-a5f8-2510df6cd8c5/documents/657ba275-b020-47bc-b586-42a03795c085_96e57677-6195-4e81-b042-a6cfc70e055f.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, imidacloprid (ISO); 1-(6-chloropyridin-3-ylmethyl)-N-nitroimidazolidin-2-ylidenamine,138261-41-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55653e15-12ad-485a-a5f8-2510df6cd8c5/documents/657ba275-b020-47bc-b586-42a03795c085_96e57677-6195-4e81-b042-a6cfc70e055f.html,,inhalation,LC50,5.32 ,no adverse effect observed, "2-{2-ethoxy-5-[(4-ethylpiperazin-1-yl)sulfonyl]phenyl}-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(1H)-one",224785-90-4,"Bay 38-7268 is non toxic after single oral exposure (LD50 cut-off, rat: > 2500 mg/kg bw). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44df191f-a233-4e55-81dc-56252a952eea/documents/IUC5-cd0fe54d-60ae-47fe-8c7f-42800ee22e7e_cacf304a-aca2-40c6-bf4f-1fc5bb817930.html,,,,,, "2-{2-ethoxy-5-[(4-ethylpiperazin-1-yl)sulfonyl]phenyl}-5-methyl-7-propylimidazo[5,1-f][1,2,4]triazin-4(1H)-one",224785-90-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44df191f-a233-4e55-81dc-56252a952eea/documents/IUC5-cd0fe54d-60ae-47fe-8c7f-42800ee22e7e_cacf304a-aca2-40c6-bf4f-1fc5bb817930.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, di-tert-butyl {5-bromo-3-[(1R)-1-(2-{[(5-cyano-1-methyl-1H-pyrazol-3-yl)methyl](methyl)carbamoyl}-5-fluorophenyl)ethoxy]pyridin-2-yl}imidodicarbonate t-amyl alcohol solvate,1910113-99-3,"One study on rats is available.LD50 in Wistar rats was established to exceed 2000 mg/kg body weight (Latour J.E.H.M., MSc., 2016). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97a6348c-103f-4d51-b74d-a6e8e2036889/documents/IUC5-2be4af42-d280-4b43-b2e6-9d14f3b0a569_e1646d1b-6e55-4148-9eb2-5126b88daf94.html,,,,,, di-tert-butyl {5-bromo-3-[(1R)-1-(2-{[(5-cyano-1-methyl-1H-pyrazol-3-yl)methyl](methyl)carbamoyl}-5-fluorophenyl)ethoxy]pyridin-2-yl}imidodicarbonate t-amyl alcohol solvate,1910113-99-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97a6348c-103f-4d51-b74d-a6e8e2036889/documents/IUC5-2be4af42-d280-4b43-b2e6-9d14f3b0a569_e1646d1b-6e55-4148-9eb2-5126b88daf94.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Indium,7440-74-6," In an OECD test Guideline 407 study (Repeated Dose 28 -Day Oral toxicity in rodents), rats of both sexes received by oral gavage indium at 0, 20, 400 and 1000 mg/kg. No changes related to indium with regard to clinical signs, body weights, food consumption, haematology, blood chemistry, urinalysis, organ weights, necropsy or histopathology were found. The reported NOAEL was 1000 mg/kg for males and females. High quality repeat dose whole body inhalation studies, following OECD guidelines 412 (2 -week exposure) and 413 (13 -week exposure) were conducted on indium oxide (IO) and indium tin oxide (ITO) (Nagano et al 2011) in rats and mice. Specific effects included increased lung weights, alveolar proteinosis, increased inflammatory cell infiltration and hyperplasia of the alveolar epithelium. A further group of animals was used to set-up a 13 -week recovery group at the 0.1 mg/m3 ITO dose level. The comparable results in rats are shown below:  RATS 13 wk study   IO (mg/m3)   IO (mg/m3)   IO (mg/m3)   ITO (mg/m3)   ITO (mg/m3)  ITO (mg/m3)     ITO (mg/m3)+13 wk recovery    ITO (mg/m3)+13 wk recovery   ITO (mg/m3)+13 wk recovery     0  0.1  1  0  0.1  1  0  0.1  NA  Lung weight    ↑  ↑    ↑  ↑    ↑    Alveolar proteinosis     +   + +     +    AM infiltration    + (slight)  +   +   +    +    Inflammatory cell infiltration      +      +    +    Hyperplasia alveolar epithelium      +          +    BALT granuloma                    Alveolar wall fibrosis                +    Pleural thickening                +    LN granuloma      +    +   +  +        NOAEL      LOAEL         AM: alveolar macrophages; LN: Lymph nodes   If the results of the studies are evaluated in context with the guidance produced by the SCOEL committee (Ref: European Commission Methodology for the derivation of occupational exposure limits. Scientific Committee on Occupational Exposure Limits (SCOEL). Key documentation (version 7), June 2013) on setting an OEL, where the objective of Council Directive 80/1107/EC is ""The protection of workers against risks to their health and safety from exposure to chemical, physical and biological agents considered harmful"" then the data used to derive an OEL should be separated into the 4 categories listed below: The effects of increasing exposure to chemical substances may be viewed as a continuum: (1) no effects observed (2) compensatory effects or early effects of dubious significance without adverse health consequences (3) early health impairment (clear adverse effects) (4) overt disease, possibly death Effects may be considered to become 'adverse' during the transition from (2) to (3) above Using this guidance when interpreting the results of the 13 -week study in rat with IO it could be concluded that the 0.1 mg/m3 dose level is an NOAEL. The only effect observed at this dose level, infiltration of alveolar macrophage and neutrophils and increased lung weight, could be due to exposure to a relatively insoluble, high density metal salt. Without other clear adverse endpoints present, the 0.1mg/m3 dose level shows an adaptive response to the clearance of a relatively insoluble metallic salt and could therefore be defined as a NOAEL for the purpose of defining a DNEL or OEL. For ITO, the adverse effects were more significant even at the lowest dose tested in the rat and all lung/lymph lesions persisted in the 13-week recovery period for ITO (not measured for IO) with progression to alveolar wall fibrosis, alveolar epithelial hyperplasia, infiltration of alveolar macrophages and inflammatory cells at 0.1 mg/m3.   In mice, similar results were observed to those described in the rat studies (lesions more severe with ITO than IO) but with overall lower severity scores compared to rats, particularly for alveolar proteinosis and alveolar macrophage infiltration. There was no recovery period included in the study. In a further study, Nagano et al 2011, conducted a 2 -year carcinogenicity study on ITO in the rat and mouse to OECD Guideline 451 (see below in additional information). The table below present the LOAEL and NOAEL's for the most sensitive respiratory effects observed in the sub-chronic inhalation animal studies conducted with respirable size aerosols of indium oxide and ITO in Fisher 344 rats and B6C3F1 mice. It also calculates an NOAEL for use in subsequent chronic DNEL derivation for IO and ITO. The toxic effects of both compounds in both species were typical of lung inflammation, with the overall response for both compounds being greater in rats and the response for ITO being greater than IO in both species.   IO (mg/m3)        ITO (mg/m3) MICE     13 wk NOAEL 0.1 NA 13 wk LOAEL 1.0 (M/F) 0.1 (M/F) RATS     13 wk NOAEL 0.1 NA 13 wk LOAEL 1 (M/F) 0.1 (M/F) 2 yr NOAEL   NA 2 yr LOAEL   0.01       Choice of NOAEL/LOAEL for DNEL determination 0.1 mg/m3 0.01 mg/m3 Conversion factor from sub-chronic to chronic a 2 1 Conversion factor for NOAEL determination from a LOAEL value b 1 3       Comparable chronic NOAEL for DNEL derivation 0.05 mg/m3 0.0033 mg/m3 a –Conversion for difference in duration of exposure:2 (sub-chronic to chronic exposure) b –To convert a LOAEL to a NOAEL, the REACH TGD (Chapter R.8 of the ‘Guidance on information requirements and chemical safety assessment’) suggests an assessment factor (AF) of 3 as minimum for the majority of cases and going up to a default of 10 for exceptional cases. An AF of 3 is applied to convert LOAEL to NOAEL.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aaebb593-6768-484d-aa20-b227007bda01/documents/aa35ee0a-e8cc-4d35-980e-049bff0e6dda_10d1839d-09d2-43df-abf6-d01df6c9fc49.html,,,,,, Indium,7440-74-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aaebb593-6768-484d-aa20-b227007bda01/documents/aa35ee0a-e8cc-4d35-980e-049bff0e6dda_10d1839d-09d2-43df-abf6-d01df6c9fc49.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Indium,7440-74-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aaebb593-6768-484d-aa20-b227007bda01/documents/aa35ee0a-e8cc-4d35-980e-049bff0e6dda_10d1839d-09d2-43df-abf6-d01df6c9fc49.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.1 mg/m3,adverse effect observed,rat Indium,7440-74-6," Assessment of the acute oral toxicity of indium in Asakura et al 2008: A limit study with Crj:CD (SD) IGS rats (SPF) was carried out according to OECD guideline no 401 to assess the oral LD50. No deaths and no abnormalities in clinical signs, body weights, and necropsy findings were observed for any of the animals. An LD50 value >2000mg/kg bw was reported. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aaebb593-6768-484d-aa20-b227007bda01/documents/IUC5-176a72db-d1a7-44f5-9a22-ea90f96df955_10d1839d-09d2-43df-abf6-d01df6c9fc49.html,,,,,, Indium,7440-74-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aaebb593-6768-484d-aa20-b227007bda01/documents/IUC5-176a72db-d1a7-44f5-9a22-ea90f96df955_10d1839d-09d2-43df-abf6-d01df6c9fc49.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Indium trichloride,10025-82-8," High quality repeat dose whole body inhalation studies, following OECD guidelines 412 (2 -week exposure) and 413 (13 -week exposure) were conducted on indium oxide (IO) and indium tin oxide (ITO) (Nagano et al 2011) in rats and mice. Specific effects included increased lung weights, alveolar proteinosis, increased inflammatory cell infliltration and hyperplasia of the alveolar epithelium. A further group of animals was used to set-up a 13 -week recovery group at the 0.1 mg/m3 ITO dose level. The comparable results in rats are shown below:  RATS 13 wk study   IO (mg/m3)   IO (mg/m3)   IO (mg/m3)   ITO (mg/m3)   ITO (mg/m3)  ITO (mg/m3)     ITO (mg/m3)+13 wk recovery    ITO (mg/m3)+13 wk recovery   ITO (mg/m3)+13 wk recovery     0  0.1  1  0  0.1  1  0  0.1  NA  Lung weight    ↑  ↑    ↑  ↑    ↑    Alveolar proteinosis     +   + +     +    AM infiltration    + (slight)  +   +   +    +    Inflammatory cell infiltration      +      +    +    Hyperplasia alveolar epithelium      +          +    BALT granuloma                    Alveolar wall fibrosis                +    Pleural thickening                +    LN granuloma      +    +   +  +        NOAEL      LOAEL         AM: alveolar macrophages; LN: Lymph nodes If the results of the studies are evaluated in context with the guidance produced by the SCOEL committee (Ref: European Commission Methodology for the derivation of occupational exposure limits. Scientific Committee on Occupational Exposure Limits (SCOEL). Key documentation (version 7), June 2013) on setting an OEL, where the objective of Council Directive 80/1107/EC is ""The protection of workers against risks to their health and safety from exposure to chemical, physical and biological agents considered harmful"" then the data used to derive an OEL should be separated into the 4 categories listed below: The effects of increasing exposure to chemical substances may be viewed as a continuum: (1) no effects observed (2) compensatory effects or early effects of dubious significance without adverse health consequences (3) early health impairement (clear adverse effects) (4) overt disease, possibly death Effects may be considered to become 'adverse' during the transition from (2) to (3) above Using this guidance when interpreting the results of the 13 -week study in rat with IO it could be concluded that the 0.1 mg/m3 dose level is an NOAEL. The only effect observed at this dose level, infiltration of alveolar macrophage and neutrophils and increased lung weight, could be due to exposure to a relatively insoluble, high density metal salt. Without other clear adverse endpoints present, the 0.1mg/m3 dose level shows an adaptive resonse to the clearance of a relatively insoluble metallic salt and could therefore be defined as a NOAEL for the purpose of defining a DNEL or OEL. For ITO, the adverse effects were more significant even at the lowest dose tested in the rat and all lung/lymph lesions persisted in the 13-week recovery period for ITO (not measured for IO) with progression to alveolar wall fibrosis, alveolar epithelial hyperplasia, infiltration of alveolar macrophages and inflammatory cells at 0.1 mg/m3.   In mice, similar results were observed to those described in the rat studies (lesions more severe with ITO than IO) but with overall lower severity scores compared to rats, particularly for alveolar proteinosis and alveolar macrophage infiltration. There was no recovery period included in the study. In a further study, Nagano et al 2011, conducted a 2 -year carcinogenicity study on ITO in the rat and mouse to OECD Guideline 451 (see below in additional information). The table below present the LOAEL and NOAEL's for the most sensitive respiratory effects observed in the sub-chronic inhalation animal studies conducted with respirable size aerosols of indium oxide and ITO in Fisher 344 rats and B6C3F1 mice. It also calculates an NOAEL for use in subsequent chronic DNEL derivation for IO and ITO. The toxic effects of both compounds in both species were typical of lung inflammation, with the overall response for both compounds being greater in rats and the response for ITO being greater than IO in both species.   MICE IO (mg/m3)         ITO (mg/m3)        13 wk NOAEL 0.1 NA 13 wk LOAEL 1.0 (M/F) 0.1 (M/F) RATS 13 wk NOAEL 0.1 NA 13 wk LOAEL 1 (M/F) 0.1 (M/F) 2 yr NOAEL   NA 2 yr LOAEL   0.01       Choice of NOAEL/LOAEL for DNEL determination 0.1 mg/m3 0.01 mg/m3 Conversion factor from sub-chronic to chronica 2 1 Conversion factor for NOAEL determination from a LOAEL valueb 1 3       Comparable chronic NOAEL for DNEL derivation 0.05 mg/m3 0.0033 mg/m3 a –Conversion for difference in duration of exposure:2 (sub-chronic to chronic exposure) b –To convert a LOAEL to a NOAEL, the REACH TGD (Chapter R.8 of the ‘Guidance on information requirements and chemical safety assessment’) suggests an assessment factor (AF) of 3 as minimum for the majority of cases and going up to a default of 10 for exceptional cases. An AF of 3 is applied to convert LOAEL to NOAEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20c20198-f8af-4e36-8f8f-ca132ba28a3d/documents/6427d29c-a180-40c1-ba56-28f9d6ccb0aa_774f4832-9202-42bc-88e3-bda05bfccef2.html,,,,,, Indium trichloride,10025-82-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20c20198-f8af-4e36-8f8f-ca132ba28a3d/documents/6427d29c-a180-40c1-ba56-28f9d6ccb0aa_774f4832-9202-42bc-88e3-bda05bfccef2.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.1 mg/m3,adverse effect observed,rat Indium trichloride,10025-82-8," Assessment of the acute oral toxicity of indium trichloride (InCl3) in Kiss, CiToxLAB Hungary Ltd., 2012: As no mortality was observed in Group 1 (three Wistar rats treated at a dose level of 2000mg/kg), a confirmatory group (Group 2) was treated at the same dose level. Mortality was observed in one animal in the confirmatory group, therefore no further testing was required according to OECD 423 and Commission Regulation(EC) No 440/2008 of 30 May2008, B.1.tris. Under the conditions of this study, the acute oral LD50value of the test item Indium trichloride was found to be above 2000 mg/kg bw in female Wistar CRL:(WI) rats ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20c20198-f8af-4e36-8f8f-ca132ba28a3d/documents/IUC5-913b6c6e-4027-49f6-8073-2e79e1ba8301_774f4832-9202-42bc-88e3-bda05bfccef2.html,,,,,, Indium trichloride,10025-82-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20c20198-f8af-4e36-8f8f-ca132ba28a3d/documents/IUC5-913b6c6e-4027-49f6-8073-2e79e1ba8301_774f4832-9202-42bc-88e3-bda05bfccef2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Indium trihydroxide,20661-21-6," High quality repeat dose whole body inhalation studies, following OECD guidelines 412 (2 -week exposure) and 413 (13 -week exposure) were conducted on indium oxide (IO) and indium tin oxide (ITO) (Nagano et al 2011) in rats and mice. Specific effects included increased lung weights, alveolar proteinosis, increased inflammatory cell infliltration and hyperplasia of the alveolar epithelium. A further group of animals was used to set-up a 13 -week recovery group at the 0.1 mg/m3 ITO dose level. The comparable results in rats are shown below:  RATS 13 wk study   IO (mg/m3)   IO (mg/m3)   IO (mg/m3)   ITO (mg/m3)   ITO (mg/m3)  ITO (mg/m3)     ITO (mg/m3)+13 wk recovery    ITO (mg/m3)+13 wk recovery   ITO (mg/m3)+13 wk recovery     0  0.1  1  0  0.1  1  0  0.1  NA  Lung weight    ↑  ↑    ↑  ↑    ↑    Alveolar proteinosis     +   + +     +    AM infiltration    + (slight)  +   +   +    +    Inflammatory cell infiltration      +      +    +    Hyperplasia alveolar epithelium      +          +    BALT granuloma                    Alveolar wall fibrosis                +    Pleural thickening                +    LN granuloma      +    +   +  +        NOAEL      LOAEL         AM: alveolar macrophages; LN: Lymph nodes If the results of the studies are evaluated in context with the guidance produced by the SCOEL committee (Ref: European Commission Methodology for the derivation of occupational exposure limits. Scientific Committee on Occupational Exposure Limits (SCOEL). Key documentation (version 7), June 2013) on setting an OEL, where the objective of Council Directive 80/1107/EC is ""The protection of workers against risks to their health and safety from exposure to chemical, physical and biological agents considered harmful"" then the data used to derive an OEL should be separated into the 4 categories listed below: The effects of increasing exposure to chemical substances may be viewed as a continuum: (1) no effects observed (2) compensatory effects or early effects of dubious significance without adverse health consequences (3) early health impairement (clear adverse effects) (4) overt disease, possibly death Effects may be considered to become 'adverse' during the transition from (2) to (3) above Using this guidance when interpreting the results of the 13 -week study in rat with IO it could be concluded that the 0.1 mg/m3 dose level is an NOAEL. The only effect observed at this dose level, infiltration of alveolar macrophage and neutrophils and increased lung weight, could be due to exposure to a relatively insoluble, high density metal salt. Without other clear adverse endpoints present, the 0.1mg/m3 dose level shows an adaptive resonse to the clearance of a relatively insoluble metallic salt and could therefore be defined as a NOAEL for the purpose of defining a DNEL or OEL. For ITO, the adverse effects were more significant even at the lowest dose tested in the rat and all lung/lymph lesions persisted in the 13-week recovery period for ITO (not measured for IO) with progression to alveolar wall fibrosis, alveolar epithelial hyperplasia, infiltration of alveolar macrophages and inflammatory cells at 0.1 mg/m3.   In mice, similar results were observed to those described in the rat studies (lesions more severe with ITO than IO) but with overall lower severity scores compared to rats, particularly for alveolar proteinosis and alveolar macrophage infiltration. There was no recovery period included in the study. In a further study, Nagano et al 2011, conducted a 2 -year carcinogenicity study on ITO in the rat and mouse to OECD Guideline 451 (see below in additional information). The table below present the LOAEL and NOAEL's for the most sensitive respiratory effects observed in the sub-chronic inhalation animal studies conducted with respirable size aerosols of indium oxide and ITO in Fisher 344 rats and B6C3F1 mice. It also calculates an NOAEL for use in subsequent chronic DNEL derivation for IO and ITO. The toxic effects of both compounds in both species were typical of lung inflammation, with the overall response for both compounds being greater in rats and the response for ITO being greater than IO in both species.   MICE IO (mg/m3)         ITO (mg/m3)        13 wk NOAEL 0.1 NA 13 wk LOAEL 1.0 (M/F) 0.1 (M/F) RATS 13 wk NOAEL 0.1 NA 13 wk LOAEL 1 (M/F) 0.1 (M/F) 2 yr NOAEL   NA 2 yr LOAEL   0.01       Choice of NOAEL/LOAEL for DNEL determination 0.1 mg/m3 0.01 mg/m3 Conversion factor from sub-chronic to chronica 2 1 Conversion factor for NOAEL determination from a LOAEL valueb 1 3       Comparable chronic NOAEL for DNEL derivation 0.05 mg/m3 0.0033 mg/m3 a –Conversion for difference in duration of exposure:2 (sub-chronic to chronic exposure) b –To convert a LOAEL to a NOAEL, the REACH TGD (Chapter R.8 of the ‘Guidance on information requirements and chemical safety assessment’) suggests an assessment factor (AF) of 3 as minimum for the majority of cases and going up to a default of 10 for exceptional cases. An AF of 3 is applied to convert LOAEL to NOAEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89bd714b-770b-415f-91aa-6da770bcf349/documents/00e13dec-4cf3-403f-88b8-961ed7eba75f_f7eb80a3-5c88-4e85-b080-5795cc144bc9.html,,,,,, Indium trihydroxide,20661-21-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89bd714b-770b-415f-91aa-6da770bcf349/documents/00e13dec-4cf3-403f-88b8-961ed7eba75f_f7eb80a3-5c88-4e85-b080-5795cc144bc9.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.1 mg/m3,adverse effect observed,rat Indium trihydroxide,20661-21-6," Assessment of the acute oral toxicity of indium in Asakura et al 2008: A limit study with Crj:CD (SD) IGS rats (SPF) was carried out according to OECD guideline no 401 to assess the oral LD50. No deaths and no abnormalities in clinical signs, body weights, and necropsy findings were observed for any of the animals. An LD50 value >2000mg/kg bw was reported. No acute inhalation toxicity data were identified, or are required at this tonnage (1-10 tpa). No acute dermal toxicity data were identified, or are required at this tonnage (1-10 tpa). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89bd714b-770b-415f-91aa-6da770bcf349/documents/c49e91e8-dbbd-44d3-8660-7b674904523d_f7eb80a3-5c88-4e85-b080-5795cc144bc9.html,,,,,, Indium trihydroxide,20661-21-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89bd714b-770b-415f-91aa-6da770bcf349/documents/c49e91e8-dbbd-44d3-8660-7b674904523d_f7eb80a3-5c88-4e85-b080-5795cc144bc9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Indium trinitrate,13770-61-1," High quality repeat dose whole body inhalation studies, following OECD guidelines 412 (2 -week exposure) and 413 (13 -week exposure) were conducted on indium oxide (IO) and indium tin oxide (ITO) (Nagano et al 2011) in rats and mice. Specific effects included increased lung weights, alveolar proteinosis, increased inflammatory cell infliltration and hyperplasia of the alveolar epithelium. A further group of animals was used to set-up a 13 -week recovery group at the 0.1 mg/m3 ITO dose level. The comparable results in rats are shown below:  RATS 13 wk study   IO (mg/m3)   IO (mg/m3)   IO (mg/m3)   ITO (mg/m3)   ITO (mg/m3)  ITO (mg/m3)     ITO (mg/m3)+13 wk recovery    ITO (mg/m3)+13 wk recovery   ITO (mg/m3)+13 wk recovery     0  0.1  1  0  0.1  1  0  0.1  NA  Lung weight    ↑  ↑    ↑  ↑    ↑    Alveolar proteinosis     +   + +     +    AM infiltration    + (slight)  +   +   +    +    Inflammatory cell infiltration      +      +    +    Hyperplasia alveolar epithelium      +          +    BALT granuloma                    Alveolar wall fibrosis                +    Pleural thickening                +    LN granuloma      +    +   +  +        NOAEL      LOAEL         AM: alveolar macrophages; LN: Lymph nodes If the results of the studies are evaluated in context with the guidance produced by the SCOEL committee (Ref: European Commission Methodology for the derivation of occupational exposure limits. Scientific Committee on Occupational Exposure Limits (SCOEL). Key documentation (version 7), June 2013) on setting an OEL, where the objective of Council Directive 80/1107/EC is ""The protection of workers against risks to their health and safety from exposure to chemical, physical and biological agents considered harmful"" then the data used to derive an OEL should be separated into the 4 categories listed below: The effects of increasing exposure to chemical substances may be viewed as a continuum: (1) no effects observed (2) compensatory effects or early effects of dubious significance without adverse health consequences (3) early health impairement (clear adverse effects) (4) overt disease, possibly death Effects may be considered to become 'adverse' during the transition from (2) to (3) above Using this guidance when interpreting the results of the 13 -week study in rat with IO it could be concluded that the 0.1 mg/m3 dose level is an NOAEL. The only effect observed at this dose level, infiltration of alveolar macrophage and neutrophils and increased lung weight, could be due to exposure to a relatively insoluble, high density metal salt. Without other clear adverse endpoints present, the 0.1mg/m3 dose level shows an adaptive resonse to the clearance of a relatively insoluble metallic salt and could therefore be defined as a NOAEL for the purpose of defining a DNEL or OEL. For ITO, the adverse effects were more significant even at the lowest dose tested in the rat and all lung/lymph lesions persisted in the 13-week recovery period for ITO (not measured for IO) with progression to alveolar wall fibrosis, alveolar epithelial hyperplasia, infiltration of alveolar macrophages and inflammatory cells at 0.1 mg/m3.   In mice, similar results were observed to those described in the rat studies (lesions more severe with ITO than IO) but with overall lower severity scores compared to rats, particularly for alveolar proteinosis and alveolar macrophage infiltration. There was no recovery period included in the study. In a further study, Nagano et al 2011, conducted a 2 -year carcinogenicity study on ITO in the rat and mouse to OECD Guideline 451 (see below in additional information). The table below present the LOAEL and NOAEL's for the most sensitive respiratory effects observed in the sub-chronic inhalation animal studies conducted with respirable size aerosols of indium oxide and ITO in Fisher 344 rats and B6C3F1 mice. It also calculates an NOAEL for use in subsequent chronic DNEL derivation for IO and ITO. The toxic effects of both compounds in both species were typical of lung inflammation, with the overall response for both compounds being greater in rats and the response for ITO being greater than IO in both species.   MICE IO (mg/m3)         ITO (mg/m3)        13 wk NOAEL 0.1 NA 13 wk LOAEL 1.0 (M/F) 0.1 (M/F) RATS 13 wk NOAEL 0.1 NA 13 wk LOAEL 1 (M/F) 0.1 (M/F) 2 yr NOAEL   NA 2 yr LOAEL   0.01       Choice of NOAEL/LOAEL for DNEL determination 0.1 mg/m3 0.01 mg/m3 Conversion factor from sub-chronic to chronica 2 1 Conversion factor for NOAEL determination from a LOAEL valueb 1 3       Comparable chronic NOAEL for DNEL derivation 0.05 mg/m3 0.0033 mg/m3 a –Conversion for difference in duration of exposure:2 (sub-chronic to chronic exposure) b –To convert a LOAEL to a NOAEL, the REACH TGD (Chapter R.8 of the ‘Guidance on information requirements and chemical safety assessment’) suggests an assessment factor (AF) of 3 as minimum for the majority of cases and going up to a default of 10 for exceptional cases. An AF of 3 is applied to convert LOAEL to NOAEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b576465d-4244-4945-80f3-6a96dc8578f7/documents/de77b2b1-a9d6-492c-a64d-4d477599ef0d_84020234-1c9e-4995-83b6-e2c4bc9e9c20.html,,,,,, Indium trinitrate,13770-61-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b576465d-4244-4945-80f3-6a96dc8578f7/documents/de77b2b1-a9d6-492c-a64d-4d477599ef0d_84020234-1c9e-4995-83b6-e2c4bc9e9c20.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.1 mg/m3,adverse effect observed,rat Indium trinitrate,13770-61-1," Assessment of the acute oral toxicity of indium trichloride (InCl3) in Kiss, CiToxLAB Hungary Ltd., 2012: As no mortality was observed in Group 1 (three Wistar rats treated at a dose level of 2000mg/kg), a confirmatory group (Group 2) was treated at the same dose level. Mortality was observed in one animal in the confirmatory group, therefore no further testing was required according to OECD 423 and Commission Regulation(EC) No 440/2008 of 30 May2008, B.1.tris. Under the conditions of this study, the acute oral LD50value of the test item Indium trichloride was found to be above 2000 mg/kg bw in female Wistar CRL:(WI) rats No acute inhalation toxicity data were identified, or are required at this tonnage (1-10 tpa). No acute dermal toxicity data were identified, or are required at this tonnage (1-10 tpa). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b576465d-4244-4945-80f3-6a96dc8578f7/documents/fd1ac264-0dd3-42b9-a55a-7f934e20191b_84020234-1c9e-4995-83b6-e2c4bc9e9c20.html,,,,,, Indium trinitrate,13770-61-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b576465d-4244-4945-80f3-6a96dc8578f7/documents/fd1ac264-0dd3-42b9-a55a-7f934e20191b_84020234-1c9e-4995-83b6-e2c4bc9e9c20.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Indium, cake",69029-48-7,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents (assessment entity approach. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ab7bcb7-026f-49cc-8960-64b387cdd87c/documents/df6c1b8b-b056-4618-895e-4b4a7dd862a8_cf4c5bf7-caf1-4237-b114-3d25d48fd514.html,,,,,, "Indium, cake",69029-48-7,The acute toxicity is driven by the characteristics of the individual UVCB constituents (assessment entity approach). Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ab7bcb7-026f-49cc-8960-64b387cdd87c/documents/19c81039-dcb8-402f-8b1c-e10572a51728_cf4c5bf7-caf1-4237-b114-3d25d48fd514.html,,,,,, Inulinase,9025-67-6," No deaths, clinical symptoms or macroscopic findings were seen in any of the mice, but a decrease in body weight gain was seen in the highest dosed males. As no deaths occured the LD50 value was estimated to be over 15000 mg/kg for both males and females and Novozym 230 could be classified ""relatively harmless"" according to Guidebook: Toxic Substances Control Act, George Dorninquez, 1977. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/699983c2-e1fc-4bc3-a074-1ba175c422ce/documents/3e7bd07c-01cd-49b0-a05c-646560d1b26f_1129be8b-01fc-41f6-801a-f4d386e80639.html,,,,,, Iodine monochloride,7790-99-0,"There are no acute toxicity studies of iodmonochlorid available. Results of two acute toxicity studies are cited in RTECS database: Oral (rat): LDLo 50 mg/kg bw(Kodak Company Reports (343 State St., Rochester, NY 14650) 21 May 1971) Dermal (rat): LDLo 500 mg/kg bw(Kodak Company Reports (343 State St., Rochester, NY 14650) 21 May 1971) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57723e75-22e8-4927-93af-b28f710d3635/documents/IUC5-a1c7246e-8b33-4c90-92ac-dc3a2f82156e_cbf8f655-d248-4987-a22e-79270560bcab.html,,,,,, Iodine pentafluoride,7783-66-6,The lowest LOAEL of 0.55 mg/kg bw/day was observed in the 2-year study with rats with potassium iodide in the drinking water. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4df87364-0493-453f-87a1-b9c1fd3d3a89/documents/IUC5-3022c3d4-03a4-42ed-9e78-c632b84f73c5_8ed2b021-38a6-4baa-94ec-cbda5482a6c2.html,,,,,, Iodine pentafluoride,7783-66-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4df87364-0493-453f-87a1-b9c1fd3d3a89/documents/IUC5-3022c3d4-03a4-42ed-9e78-c632b84f73c5_8ed2b021-38a6-4baa-94ec-cbda5482a6c2.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.72 mg/m3,,rat Iodine pentafluoride,7783-66-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4df87364-0493-453f-87a1-b9c1fd3d3a89/documents/IUC5-3022c3d4-03a4-42ed-9e78-c632b84f73c5_8ed2b021-38a6-4baa-94ec-cbda5482a6c2.html,Chronic toxicity – systemic effects,oral,LOAEL,0.55 mg/kg bw/day,,rat Iodine pentafluoride,7783-66-6,"Since IF5 is corrosive to the skin, the acute oral, inhalation, and dermal toxicity studies could not be performed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4df87364-0493-453f-87a1-b9c1fd3d3a89/documents/IUC5-4fcc2da7-9994-4d4d-9c7e-b568e0bd1136_8ed2b021-38a6-4baa-94ec-cbda5482a6c2.html,,,,,, Iodo(triphenylphosphino)copper,47107-74-4," Considering results of the structural similar compound Iodotris(triphenylphosphino)copper, the dose of 1.000 mg/kg body weight/day (dose of the high dose group) can be declared as the NOAEL (No Observed Adverse Effect Level) after the 28 days treatment for Iodo(triphenylphosphino)copper. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c55cf4b5-4a94-4d69-a903-c7360f92b940/documents/40adb25d-ca02-4df6-b322-d9afe2d46d80_0fa6f6b5-21dc-445e-b033-7c140ded04d0.html,,,,,, Iodo(triphenylphosphino)copper,47107-74-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c55cf4b5-4a94-4d69-a903-c7360f92b940/documents/40adb25d-ca02-4df6-b322-d9afe2d46d80_0fa6f6b5-21dc-445e-b033-7c140ded04d0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Iodo(triphenylphosphino)copper,47107-74-4, LD50 (oral) > 2.000 mg/kg bw LD50 (dermal) > 2.000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c55cf4b5-4a94-4d69-a903-c7360f92b940/documents/221dc646-20e0-46a6-bef2-d6d898475df1_0fa6f6b5-21dc-445e-b033-7c140ded04d0.html,,,,,, Iodo(triphenylphosphino)copper,47107-74-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c55cf4b5-4a94-4d69-a903-c7360f92b940/documents/221dc646-20e0-46a6-bef2-d6d898475df1_0fa6f6b5-21dc-445e-b033-7c140ded04d0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Iodo(triphenylphosphino)copper,47107-74-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c55cf4b5-4a94-4d69-a903-c7360f92b940/documents/221dc646-20e0-46a6-bef2-d6d898475df1_0fa6f6b5-21dc-445e-b033-7c140ded04d0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, bis(4-tert-butylphenyl)iodonium hexafluorophosphate,61358-25-6,"Oral (OECD 423), rat: LD50 (cut-off) > 2500 mg/kg bw/day ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6da377de-835e-4301-beee-225be8500c39/documents/IUC5-29136293-e955-45d8-bf11-c7402372175b_f8f1db17-3751-49db-891c-63bffd09f00c.html,,,,,, Iotroxic acid,51022-74-3," In acute oral toxicity studies, the acute toxic potential of Iotroxic acid was tested orally on male and female mice and rats. The LD50 of the test substance for mice was found to be greater than 9000 mg/kg bw for both male and female mice and rats. In acute dermal toxicity studies, the acute toxic potential of Iotroxic acid was tested dermally on male and female rats and mice. The LD50 of the test substance for rats was found to be 8050 mg/kg bw for males and 7100 mg/kg bw for females. The LD50 of the test substance for mice was found to be 6150 mg/kg bw for males and 6500 mg/kg bw for females. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1dc8ee1f-d917-4652-bcfd-e0bda8dd2671/documents/5e3a34c4-5d4a-4e07-b5a6-355c76c24cd2_43175192-1cca-44b0-bfeb-ce73b51ee59e.html,,,,,, "2-Propenoic acid, 2-methyl-, 3-methyl-3-buten-1-yl ester",156291-88-2,IPEMA does not fulfill the criteria for classification as acute toxic for the oral pathway under CLP ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a579f1f4-66c9-4e73-b703-329c6f377fad/documents/11f97f06-06ea-4363-a7a2-96349fd81263_e736b255-06ed-4ca6-8c78-eff8db901834.html,,,,,, "2-Propenoic acid, 2-methyl-, 3-methyl-3-buten-1-yl ester",156291-88-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a579f1f4-66c9-4e73-b703-329c6f377fad/documents/11f97f06-06ea-4363-a7a2-96349fd81263_e736b255-06ed-4ca6-8c78-eff8db901834.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Iridium,7439-88-5," A GLP compliant study was performed to assess the acute oral toxicity of Iridium to the rat according to OECD guideline 420. Iridium was administered orally as a suspension in 1% Carboxymethylcellulose (CMC). Up to a dose level of 2000 mg/kg body weight, no mortality occured. It was concluded that the acute median lethal oral dose (LD50) to rats was greater than 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0bc31a54-517c-4769-8310-070175ea1574/documents/b14d4b9d-042b-40d7-800f-6e73336a006b_8e92db44-0e05-4034-9615-85573d534483.html,,,,,, Iridium,7439-88-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0bc31a54-517c-4769-8310-070175ea1574/documents/b14d4b9d-042b-40d7-800f-6e73336a006b_8e92db44-0e05-4034-9615-85573d534483.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Iron chloride sulphate,12410-14-9,"- Repeated dose toxicity, oral: • FeCl3: no classification, NOAEL = 277 mg/kg bw/d, LOAEL = 554 mg/kg bw/d, 1 study (probably comparable to OECD TG 408) • Fe2(SO4)3: no classification, no studies available, accordingly read across is used from FeCl3: NOAEL = 277 mg/kg bw/d * (399.88 g/mol/2 * 162.21 g/mol) = 341.4 mg/kg bw/d, LOAEL = 683 mg/kg bw/d • FeCl2: no classification (as treatment period was at least 42 d and dosed 7 d/week), NOAEL = 125 mg/kg bw, LOAEL: 250 mg/kg bw, 1 study (compliant to OECD TG 422 and GLP • FeSO4: no classification (effects at 163.9 mg/kg bw/d not sufficient for classification), NOAEL = 54.6 mg/kg bw, LOAEL = 163.9 mg/kg bw/d for anhydrous FeSO4, 1 study (compliant to OECD TG 422 and GLP) • FeClSO4: no classification, no studies available, accordingly read across is used from FeCl3: NOAEL = 277 mg/kg bw/d * (187.36 g/mol/62.21 g/mol) = 319.9 mg/kg bw/d, LOAEL = 639.9 mg/kg bw/d- Repeated dose toxicity, dermal: no studies available- Repeated dose toxicity, inhalation: • FeCl3: one reliable but not sufficient conclusive for classification study in rabbits reported a LOAEL of 1.4 mg Fe/m³, when exposed to FeCl3 aerosol ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4f83e53-e19a-4d2b-8284-2c74d5f37bdd/documents/IUC5-c1d25457-1f03-43a9-8ec1-f709dce1727a_8730efe3-3591-4728-b8bf-3dbf1992fc03.html,,,,,, Iron chloride sulphate,12410-14-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4f83e53-e19a-4d2b-8284-2c74d5f37bdd/documents/IUC5-c1d25457-1f03-43a9-8ec1-f709dce1727a_8730efe3-3591-4728-b8bf-3dbf1992fc03.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Iron chloride sulphate,12410-14-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4f83e53-e19a-4d2b-8284-2c74d5f37bdd/documents/IUC5-c1d25457-1f03-43a9-8ec1-f709dce1727a_8730efe3-3591-4728-b8bf-3dbf1992fc03.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1.4 mg/m3,adverse effect observed,rabbit Iron chloride sulphate,12410-14-9,"Acute toxicity, oral: H302: Harmful if swallowed, Category 4, OECD TG 423; study Choi 2005Acute toxicity, inhalation: No adverse effect observed in limit study, EPA OPP 81-3; US EPA 1993/Robbins 1991Acute toxicity, dermal: Non-toxic, OECD TG 402; study Choi 2004 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4f83e53-e19a-4d2b-8284-2c74d5f37bdd/documents/IUC5-49d88153-535f-48bb-b52b-3e2ae3051b05_8730efe3-3591-4728-b8bf-3dbf1992fc03.html,,,,,, Iron chloride sulphate,12410-14-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4f83e53-e19a-4d2b-8284-2c74d5f37bdd/documents/IUC5-49d88153-535f-48bb-b52b-3e2ae3051b05_8730efe3-3591-4728-b8bf-3dbf1992fc03.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Iron chloride sulphate,12410-14-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4f83e53-e19a-4d2b-8284-2c74d5f37bdd/documents/IUC5-49d88153-535f-48bb-b52b-3e2ae3051b05_8730efe3-3591-4728-b8bf-3dbf1992fc03.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Iron chloride sulphate,12410-14-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4f83e53-e19a-4d2b-8284-2c74d5f37bdd/documents/IUC5-49d88153-535f-48bb-b52b-3e2ae3051b05_8730efe3-3591-4728-b8bf-3dbf1992fc03.html,,inhalation,discriminating conc.,"1,100 mg/m3",no adverse effect observed, Iron cobalt black spinel,68187-50-8, There is no study available with the target substance. In a study similar to OECD TG 423 performed with the structural analogue substance Iron cobalt chromite black spinel a discriminating dose > 2000 mg/kg bw in rats was observed. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b54a1842-a7ec-4a83-be61-09ddb45c1823/documents/547167be-d293-44f5-88c0-1b5c083bc715_362a17ed-1e6a-42fa-89db-0029bbfbdac0.html,,,,,, Iron cobalt black spinel,68187-50-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b54a1842-a7ec-4a83-be61-09ddb45c1823/documents/547167be-d293-44f5-88c0-1b5c083bc715_362a17ed-1e6a-42fa-89db-0029bbfbdac0.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Iron cobalt chromite black spinel,68186-97-0,"In conclusion, since the dissolved Cr, Ni, Co, Mn and Fe concentrations (in GST/ALF) were below 9.06 µg/L, 4.39 µg/L, 13.7 µg/L, 17.1 µg/L and 65 µg/L respectively, even at the highest loading of 0.1g/L, referring to a solubility of 0.009%, 0,005%, 0,014, 0,017 % and 0.07%, the pigment is considered biologically inert. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5337d5da-2bef-4ee8-a8d0-850f08fb7e24/documents/IUC5-182b7abc-2dd6-4ccb-81f8-ad3cc72b9abc_79033af0-3516-4be5-822a-2bdafae3f421.html,,,,,, Iron cobalt chromite black spinel,68186-97-0,Acute oral toxicity: LD50 > 2000 mg/kg bw (equivalent or similar to OECD 423 (2001); Non-GLP compliant)Acute inhalation toxicity: LC50 (rats; 4 hours) > 5.09 mg/L air (actual concentration) (OECD 436 (2009); GLP compliant) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5337d5da-2bef-4ee8-a8d0-850f08fb7e24/documents/IUC5-5e237f26-1642-43c2-970a-bd279237657a_79033af0-3516-4be5-822a-2bdafae3f421.html,,,,,, Iron dichloride,7758-94-3,"- Repeated dose toxicity, oral: • FeCl3: no classification, NOAEL = 277 mg/kg bw/d, LOAEL = 554 mg/kg bw/d, 1 study (probably comparable to OECD TG 408) • Fe2(SO4)3: no classification, no studies available, accordingly read across is used from FeCl3: NOAEL = 277 mg/kg bw/d * (399.88 g/mol/2 * 162.21 g/mol) = 341.4 mg/kg bw/d, LOAEL = 683 mg/kg bw/d • FeCl2: no classification (as treatment period was at least 42 d and dosed 7 d/week), NOAEL = 125 mg/kg bw, LOAEL: 250 mg/kg bw, 1 study (compliant to OECD TG 422 and GLP • FeSO4: no classification (effects at 163.9 mg/kg bw/d not sufficient for classification), NOAEL = 54.6 mg/kg bw, LOAEL = 163.9 mg/kg bw/d for anhydrous FeSO4, 1 study (compliant to OECD TG 422 and GLP) • FeClSO4: no classification, no studies available, accordingly read across is used from FeCl3: NOAEL = 277 mg/kg bw/d * (187.36 g/mol/62.21 g/mol) = 319.9 mg/kg bw/d, LOAEL = 639.9 mg/kg bw/d- Repeated dose toxicity, dermal: no studies available- Repeated dose toxicity, inhalation: • FeCl3: one reliable but not sufficient conclusive for classification study in rabbits reported a LOAEL of 1.4 mg Fe/m³, when exposed to FeCl3 aerosol ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4992bd5-0946-4953-b683-fc47c48ae16c/documents/IUC5-e594d550-6483-4a2b-a04f-f53f9547e559_32d016f6-39a9-475e-b81e-4a7b8a809627.html,,,,,, Iron dichloride,7758-94-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4992bd5-0946-4953-b683-fc47c48ae16c/documents/IUC5-e594d550-6483-4a2b-a04f-f53f9547e559_32d016f6-39a9-475e-b81e-4a7b8a809627.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Iron dichloride,7758-94-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4992bd5-0946-4953-b683-fc47c48ae16c/documents/IUC5-e594d550-6483-4a2b-a04f-f53f9547e559_32d016f6-39a9-475e-b81e-4a7b8a809627.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1.4 mg/m3,adverse effect observed,rabbit Iron dichloride,7758-94-3,"Acute toxicity, oral: H302: Harmful if swallowed, Category 4, OECD TG 423; study Choi 2005Acute toxicity, inhalation: No adverse effect observed in limit study, EPA OPP 81-3; US EPA 1993/Robbins 1991Acute toxicity, dermal: Non-toxic, OECD TG 402; study Choi 2004 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4992bd5-0946-4953-b683-fc47c48ae16c/documents/IUC5-17b9b34b-2bec-429b-9767-99ec6ab20e32_32d016f6-39a9-475e-b81e-4a7b8a809627.html,,,,,, Iron dichloride,7758-94-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4992bd5-0946-4953-b683-fc47c48ae16c/documents/IUC5-17b9b34b-2bec-429b-9767-99ec6ab20e32_32d016f6-39a9-475e-b81e-4a7b8a809627.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Iron dichloride,7758-94-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4992bd5-0946-4953-b683-fc47c48ae16c/documents/IUC5-17b9b34b-2bec-429b-9767-99ec6ab20e32_32d016f6-39a9-475e-b81e-4a7b8a809627.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Iron dichloride,7758-94-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4992bd5-0946-4953-b683-fc47c48ae16c/documents/IUC5-17b9b34b-2bec-429b-9767-99ec6ab20e32_32d016f6-39a9-475e-b81e-4a7b8a809627.html,,inhalation,discriminating conc.,"1,100 mg/m3",no adverse effect observed, Iron manganese trioxide,12062-81-6,"A subacute inhalation toxicity study for Fe3O4, Fe2O3 and FeOOH and a subchronic inhalation study for Fe3O4 as representative source substances for the iron oxide category members are available. Additionally, a short-term (5-day) inhalation study with two different grades of nanomaterials was conducted. Rats were exposed to 10 and 30 mg/m³ of smaller nano-sized Fe2O3 and 30 mg/m³ of larger nano-sized Fe2O3. Sub-chronic repeated dose toxicity studies with Fe3O4, Fe2O3 and FeOOH as representative source substances for the iron oxide category members are available. A NOAEL of greater than 1000 mg/kg bw/day is derived for all three substances, based on a complete absence of adverse effects. For repeated dose toxicity via the dermal route, no reliable studies are available for the iron oxide category. Details on the category justification are given in the read-across document attached in IUCLID section 13.2. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d66a1cf0-3d82-439c-b279-4203d38f0996/documents/0739d32e-780b-4ffb-998e-1e4550501ef7_6805948f-37b7-43d8-a8b9-63b2ee35fbed.html,,,,,, Iron manganese trioxide,12062-81-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d66a1cf0-3d82-439c-b279-4203d38f0996/documents/0739d32e-780b-4ffb-998e-1e4550501ef7_6805948f-37b7-43d8-a8b9-63b2ee35fbed.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4.7 mg/m3,adverse effect observed,rat Iron manganese trioxide,12062-81-6,"In an oral acute toxicity study 10 animals were treated with 10000 mg/kg bw (Fe,Mn)3O4 (CAS 68186-94-7) as a surrogate for (Fe,Mn)2O3. During an observation time of 14 days none of the animals showed signs of toxicity or died. In an acute inhalation toxicity study with Fe2O3 as a surrogate for the iron oxide group the discriminating dose was 5050 mg/m³. No study for acute dermal toxicity is available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d66a1cf0-3d82-439c-b279-4203d38f0996/documents/IUC5-780de5b5-c522-4fc5-9e73-5e0aefd2c64f_6805948f-37b7-43d8-a8b9-63b2ee35fbed.html,,,,,, Iron manganese trioxide,12062-81-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d66a1cf0-3d82-439c-b279-4203d38f0996/documents/IUC5-780de5b5-c522-4fc5-9e73-5e0aefd2c64f_6805948f-37b7-43d8-a8b9-63b2ee35fbed.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, Iron manganese trioxide,12062-81-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d66a1cf0-3d82-439c-b279-4203d38f0996/documents/IUC5-780de5b5-c522-4fc5-9e73-5e0aefd2c64f_6805948f-37b7-43d8-a8b9-63b2ee35fbed.html,,inhalation,discriminating conc.,"5,050 mg/m3",no adverse effect observed, "Iron ores, agglomerates",65996-65-8,"Three repeated-dose inhalation studies with rats have been summarized in this section of Chapter 7: a 14-day study with FeO, Fe2O3 and Fe3O4, a 28-day study with Fe3O4 and a 90-day study with Fe3O4. These studies fully cover the REACH requirements as to the repeated-dose toxicity of Fe3O4 (magnetite). The three studies show at lower concentrations and/or exposure durations the normal clearance response, e.g., the mobilization of alveolar macrophages, without adverse effects in the respiratory tract. The higher concentrations and/or exposure durations tend to lead to the effects of particle overloading that are extensively described in literature: cytotoxicity, inflammation and cell proliferation (see for instance the reviews of Oberdörster 1995 and 2002). At 4.7 mg/m3 in the 90-day study there were slight increases of protein levels in the BAL, increased numbers of PMN and alveolar macrophages in the BAL and in the blood an increase of neutrophils (in the males). The author of the study reported these effects as borderline and to represent a normal adaptive response to the exposure to particles. He reported the 4.7 mg/m3 as a NOAEC. However, the effects observed at 4.7 mg/m3 can be regarded to be a result of a specific sensitivity of rats to particle overload and its sequela. In addition there were two intratracheal instillation studies with Fe2O3, in which hamsters were treated up to 15 times (once a week) with 3 mg of the substance. These very high doses did not result in clear-cut adverse effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3eb36e8f-5332-41c7-90d9-b0ae8ab97aca/documents/IUC5-5ddc84e1-19bd-4c39-aa52-b4dbad88e144_f7ad6c0b-958b-4604-a8fa-852565c979bd.html,,,,,, "Iron ores, agglomerates",65996-65-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3eb36e8f-5332-41c7-90d9-b0ae8ab97aca/documents/IUC5-5ddc84e1-19bd-4c39-aa52-b4dbad88e144_f7ad6c0b-958b-4604-a8fa-852565c979bd.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,4.7 mg/m3,,rat "Iron ores, agglomerates",65996-65-8,see below in discussion ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3eb36e8f-5332-41c7-90d9-b0ae8ab97aca/documents/IUC5-b9390ccd-a1c9-45ae-a9bf-b64341f08553_f7ad6c0b-958b-4604-a8fa-852565c979bd.html,,,,,, "Iron ores, agglomerates",65996-65-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3eb36e8f-5332-41c7-90d9-b0ae8ab97aca/documents/IUC5-b9390ccd-a1c9-45ae-a9bf-b64341f08553_f7ad6c0b-958b-4604-a8fa-852565c979bd.html,,oral,LD50,"10,000 mg/kg bw",, "Iron ores, agglomerates",65996-65-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3eb36e8f-5332-41c7-90d9-b0ae8ab97aca/documents/IUC5-b9390ccd-a1c9-45ae-a9bf-b64341f08553_f7ad6c0b-958b-4604-a8fa-852565c979bd.html,,inhalation,LC50,"2,100 mg/m3",, Iron orthophosphate,10045-86-0," No studies are provided for the endpoint 'repeated dose toxicity'. The standard testing requirement for chemicals manufactured or imported into the EU in quantities of >1,000 have been adapted on the basis that there is sufficient data to permit a robust conclusion on possibility of specific target organ toxicity as a result of repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a1be759-fb1d-48ae-94af-f3ac46fd84e2/documents/IUC5-31e4e80a-3a13-4335-b85d-26d5e01c11a5_629283f4-260f-43f6-928f-af12214a7df5.html,,,,,, Iron orthophosphate,10045-86-0," Oral: OECD 420, RL1, rat: LD50 > 2000 mg/kg bw Inhalation: OECD 436, RL1, rat, dust: LC50 > 5.05 mg/L Dermal: no study available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a1be759-fb1d-48ae-94af-f3ac46fd84e2/documents/IUC5-c796732f-8e36-48a3-bcad-4876b8291b3e_629283f4-260f-43f6-928f-af12214a7df5.html,,,,,, Iron sinter,65996-66-9,"Repeated dose toxicity -  oral: The iron oxides, show a complete absence of adverse effects in guideline compliant repeated dose toxicity studies via the oral route. Neither macroscopic, nor microscopic findings were noted. These findings were seen in a sub-chronic oral study in rats with three different iron oxides. An NOAEL was not derived based on the absence of adverse effects up to the limit dose of 1000 mg/kg bw/day. A number of sub-chronic oral repeated dose toxicity studies with iron show a substantial variability in the effect doses (NOAEL range from 68 to 1300 mg Fe/kg bw/day, with a mean of 390 mg Fe/kg bw/day). The effects described were mild increase in relative liver weight and increase in liver non-haeme Fe. In a double-blind clinical trial some very mild effects are described after treatment of anaemic patients with iron (powder) as food supplement at 1800 mg Fe/day for three weeks. The treatment was generally well-tolerated with transient gastrointestinal side effects comparable to the effects seen with soluble iron salts. A comparative group of patients was treated with a soluble iron salt at 180 mg Fe/day, very similar effects were observed compared with the iron-treated group. This data shows an approx. 10-fold lower toxicity for iron compared with soluble iron salts. For comparative purposes, toxicological data on soluble iron salts were included in this dossier The sub-acute animal studies with soluble iron salts (e.g. iron sulfate, iron chloride and iron tartrate) indicate an effect dose of 60-180 mg Fe/kg bw/day based on increased liver weights and inflammatory parameters in the gastro-intestinal tract. The effects in the gastro-intestinal tract are also identified as lead-effect in the human studies, where effect levels of 60-200 mg Fe are described. The lower effect levels for highly soluble and highly bioavailable iron substances compared to the higher effect level for iron for both in animals and humans, corroborates the assumption that solubility in water or artificial body fluids correlates with the systemic toxicity of the iron category substances.   Repeated dose toxicity - inhalation: The existing 28-day and 90-day inhalation studies with iron oxides in rats does not show any substance-related adverse effects. The effects of iron oxides after 28-day and 90-day inhalation is best compared with the effects seen with other poorly-soluble low-toxicity particles (PSLT), leading to a minimal or mild inflammatory response only at the maximum tolerated concentration in repeated dose toxicity studies via inhalation. Furthermore, in human epidemiological studies following prolonged inhalation exposure, no clinically significant adverse local or systemic effects were reported. Based on the physico-chemical properties of the particles, direct systemic exposure to iron upon inhalation can be ruled out. Based on the local effects particles can have in the respiratory tract and the physico-chemical properties of carbonyl iron, it is not expected that a longer duration would result in the detection of other effects, not solely determined by the PSP character of carbonyl iron.   Repeated dose toxicity – dermal: There is no information available on dermal toxicity. The conduct of repeated dose toxicity study is not considered to be required since inhalation of the substance is considered the most relevant route of human exposure. Furthermore, physicochemical and toxicological properties of the iron category substances do not suggest a significant rate of absorption through the skin (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af92495e-e6ed-4d45-9298-d5caf6087d51/documents/cfa225fa-6979-4fbb-b685-cc839df1b5f9_71ba7c4f-719b-477d-917e-163a92c04220.html,,,,,, Iron sinter,65996-66-9,"Acute oral toxicity: LD50 > 5000mg/kg bw Acute toxicity, inhalation: LC50 > 5 mg/L Acute toxicity, dermal: There is no information available on acute dermal toxicity but a long history of safe use. In addition, the conduct of acute dermal toxicity testing is not considered to be required since inhalation of the substance is considered the most relevant route of human exposure. Furthermore, physicochemical and toxicological properties of the substance do not suggest a significant rate of absorption through the skin (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): There is no key study available, therefore the acute oral toxicity of the substance was assessed in a weight of evidence approach. One OECD 401 (1981) study with minor restrictions (RL=2) utilizing a test substance containing 73% Fe2O3 was supported by 4 additional studies with insufficient documentation utilizing Fe2O3, FeO(OH), or Fe3O4 up to 10 mg/kg bw. Despite the insufficient documentation, all supportive studies were executed by an established toxicological test centre and therefore can be considered to be relevant. Fe2O3 and Fe3O4 are the main constituents of the substance to be assessed. The overall quality of the database is therefore sufficient. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): There is no key study available, therefore the acute oral toxicity of the substance was assessed in a weight of evidence approach. One study with minor restrictions (RL=2) equvilant to OECD403 utilizing a test substance Fe3O4 (0.64 mg/L maximum attainable concentration) was supported by one additional studies with insufficient documentation utilizing Fe2O3 exposing rats to 2100 mg/m³ and hamster to 2800 mg/m³ for 12 hours. Fe2O3 and Fe3O4 are the main constituents of the substance to be assessed. The overall quality of the database is therefore sufficient. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af92495e-e6ed-4d45-9298-d5caf6087d51/documents/873dae82-73b1-4142-890a-721a8f825229_71ba7c4f-719b-477d-917e-163a92c04220.html,,,,,, Iron sulphide,1317-37-9," A key combined repeated dose/reproductive & developmental toxicity study for subacute oral toxicity in rats was available for read across substance iron dichloride, showing NOAEL values of 125 and 250 mg/kg bw for males and females, respectively. Identified target organs were the liver, stomach and adrenal gland. Read across with iron dichloride is justified, although a factor 6 was considered in benefit of iron sulfide, which would bring the NOAEL to 750 mg/kg bw. The relevance of the stomach as target organ for iron sulfide is questioned, as it has no corrosive proporties. A 90-day study was waived based on the availability of a carcinogenicity study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf1d36c0-84c8-452c-b9a0-6dda3b36e260/documents/3e4c1ab2-588e-458f-a026-576d4fbc7f2f_ea6a6722-1b07-4904-b1ef-c36d8ac9390c.html,,,,,, Iron sulphide,1317-37-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf1d36c0-84c8-452c-b9a0-6dda3b36e260/documents/3e4c1ab2-588e-458f-a026-576d4fbc7f2f_ea6a6722-1b07-4904-b1ef-c36d8ac9390c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat Iron sulphide,1317-37-9," Key studies were available for iron sulfide for oral and dermal acute toxicity, both showing LD50 values above 2000 mg/kg bw with absence of clinical or pathological observations. For read across purpose, comparison with a worst case source chemical iron dichloride was made, showing systemic effects and lethality after (300 and) 2000 mg/kg bw. Therefore iron sulfide is safe compared to more water soluble iron salts, most probably due to limited water solubility and limited systemic absorption. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf1d36c0-84c8-452c-b9a0-6dda3b36e260/documents/99209ffc-25c1-487c-be29-c90ac541333a_ea6a6722-1b07-4904-b1ef-c36d8ac9390c.html,,,,,, Iron sulphide,1317-37-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf1d36c0-84c8-452c-b9a0-6dda3b36e260/documents/99209ffc-25c1-487c-be29-c90ac541333a_ea6a6722-1b07-4904-b1ef-c36d8ac9390c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Iron sulphide,1317-37-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf1d36c0-84c8-452c-b9a0-6dda3b36e260/documents/99209ffc-25c1-487c-be29-c90ac541333a_ea6a6722-1b07-4904-b1ef-c36d8ac9390c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Iron titanium pseudobrookite,1310-39-0," In conclusion, since the dissolved Fe, Ti and Al and concentrations from this pigment under simulated physiological conditions were below 178 µg/L, 106 µg/L and 139 µg/L (GST) , respectively even at the highest loading of 0.1g/L, corresponding to a solubility of less than 0.4 % after 24 hours, this pigment may reasonably be considered biologically inert. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e716d26a-5302-4e13-800c-4e2ef2d54382/documents/ff688df5-284a-477d-bc47-3cdef69122d2_4f083340-71b9-4e6b-b37e-9081badc58c7.html,,,,,, Iron titanium pseudobrookite,1310-39-0, Acute inhalation toxicity: LC50 > 5.08 mg/L air (analytical) (OECD 436; GLP) ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e716d26a-5302-4e13-800c-4e2ef2d54382/documents/f1e2663a-7255-4e64-b3e8-be77830b662c_4f083340-71b9-4e6b-b37e-9081badc58c7.html,,,,,, Iron trinitrate,10421-48-4,"In an oral OECD 422 study on iron sulfate heptahydrate, the NOAEL for repeated dose toxicity was 100 mg/kg bw/day (equivalent to 20 mgFe/mg kg/day) based on the extramedullary hematopoiesis of the spleen in males and increased levels of inorganic phosphate in females. The subchronic study in which ferric chloride hexahydrate was administered to Fischer 344 rats (10/sex/dose) in their drinking water at concentrations of 0.12, 0.25, 0.5, 1.0 and 2.0% (equivalent to approximately 80, 154, 277, 550 and 1231 mg/kg bw/day in male rats, 88, 176, 314, 571 and 1034 mg/kg bw/day in female rats), there were no deaths or clinical signs of toxicity. There was a significant reduction in body weight gains at the two highest doses, increased serum iron content and higher red blood cell numbers for treated males . Microscopic pathological staining indicated iron overload effects at high doses and the NOAEL was determined as 0.5% or 57 mg Fe/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73562390-58a3-4991-92d4-f5360e235769/documents/IUC5-2203435b-3e03-4ada-963f-ce4a9be15c6b_49859950-abe4-4bb4-a062-80bd6019158c.html,,,,,, Iron trinitrate,10421-48-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73562390-58a3-4991-92d4-f5360e235769/documents/IUC5-2203435b-3e03-4ada-963f-ce4a9be15c6b_49859950-abe4-4bb4-a062-80bd6019158c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,57 mg/kg bw/day,,rat Iron trinitrate,10421-48-4,Acute oral toxicity data arae available for the read-across substance iron sulphate; acute dermal toxicity data are available for the read-across substance iron dichloride. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73562390-58a3-4991-92d4-f5360e235769/documents/IUC5-1ed625cb-cc60-4190-95c0-87a911924dbb_49859950-abe4-4bb4-a062-80bd6019158c.html,,,,,, Iron trinitrate,10421-48-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73562390-58a3-4991-92d4-f5360e235769/documents/IUC5-1ed625cb-cc60-4190-95c0-87a911924dbb_49859950-abe4-4bb4-a062-80bd6019158c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Iron trinitrate,10421-48-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73562390-58a3-4991-92d4-f5360e235769/documents/IUC5-1ed625cb-cc60-4190-95c0-87a911924dbb_49859950-abe4-4bb4-a062-80bd6019158c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Iron tris(2-ethylhexanoate),7321-53-1, NOAEL on REPEATED DOSE TOXICITY >= 300 mg/kg bw ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54bd0ece-6ccf-43a7-9889-dc54d8ef932e/documents/396ccd35-9e27-4431-92ab-3ab8ddc37967_6d845c65-d220-44ba-91c5-f00b372e9ed1.html,,,,,, Iron tris(2-ethylhexanoate),7321-53-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54bd0ece-6ccf-43a7-9889-dc54d8ef932e/documents/396ccd35-9e27-4431-92ab-3ab8ddc37967_6d845c65-d220-44ba-91c5-f00b372e9ed1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Iron tris(2-ethylhexanoate),7321-53-1, Acute oral toxicity: not classified according to the CLP Regulation (EC) No. 1272/2008 Acute dermal toxicity: not classified according to the CLP Regulation (EC) No. 1272/2008 Acute inhalation toxicity: waived ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54bd0ece-6ccf-43a7-9889-dc54d8ef932e/documents/c245e26c-eaf4-44c9-be57-f3913d6253e9_6d845c65-d220-44ba-91c5-f00b372e9ed1.html,,,,,, Iron tris(phosphinate),7783-84-8," Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Ferric hypophosphite (7783-84-8).The studies are as mentioned below: 1.Acute oral toxicity study was performed in male and female wistar rats using test chemical according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method).No mortality was observed at dose 5000 mg/kg bw.Clinical signs of systemic toxicity or reaction to treatment included lethargy, uncoordinated movements and staining of the eye on day 1.No effects on body weight or weight gain were recorded. No macroscopic abnormalities were noted during necropsy.Hence,LD50 value was considered to be >5000 mg/kg bw,when wistar rats were treated with test chemical orally. 2.Acute oral toxicity study was performed in rats using test chemical.50% mortality was observed at dose 3850 mg/kg bw. Hence,LD50 value was considered to be 3850 mg/kg bw,when rats were treated with test chemical orally. Thus, based on the above summarised studies,Ferric hypophosphite (7783-84-8)and it’s structurally similar read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Ferric hypophosphite (7783-84-8) cannot be classified for acute oral toxicity.Hence,based on the data available for the structurally similar read across, test chemical Ferric hypophosphite (7783-84-8)is not likely to be toxic atleast in the dose range of 3850->5000 mg/kg bw. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2366fcde-77d5-4209-b777-2513a7d099ca/documents/775daa7e-6c66-4245-8b44-0746df3c420c_2b520bfc-aae1-4a8f-b105-0abcdac44339.html,,,,,, Iron tris(phosphinate),7783-84-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2366fcde-77d5-4209-b777-2513a7d099ca/documents/775daa7e-6c66-4245-8b44-0746df3c420c_2b520bfc-aae1-4a8f-b105-0abcdac44339.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Iron vanadium tetraoxide,13977-56-5,"No acute toxicity studies with iron vanadium tetraoxide are available, thus the acute toxicity will be addressed with existing data on the dissociation products. Iron vanadium tetraoxide is not acutely toxic via the oral route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c3ab3af-0dd8-477d-9990-3f85485cf5a3/documents/0fe9ecd8-d893-4509-8866-897e4d85b4d6_3ec6471d-05fe-4c45-a32c-1279e362b644.html,,,,,, Iron vanadium tetraoxide,13977-56-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c3ab3af-0dd8-477d-9990-3f85485cf5a3/documents/0fe9ecd8-d893-4509-8866-897e4d85b4d6_3ec6471d-05fe-4c45-a32c-1279e362b644.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Iron(3+) ion dipotassium 2-({2-[bis(carboxylatomethyl)amino]ethyl} (carboxylatomethyl)amino)acetate; hydrate,148124-40-7, NOAEL is > 84 mg EDTA-FeNa/kg bw/day for rats after 31/61 days of exposure via the food. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3efdf9e-c74e-414d-9132-20092707c651/documents/bef853b9-da73-4085-a20b-f308b762cc42_d99a32f7-313d-490b-9d1f-c3ca9f89601e.html,,,,,, Iron(3+) ion dipotassium 2-({2-[bis(carboxylatomethyl)amino]ethyl} (carboxylatomethyl)amino)acetate; hydrate,148124-40-7," Based on read across with EDTA-FeNa and EDTA-FeK: LD50 (oral, rat) exceeds 2000 mg/kg bw LD50 (dermal, rat) exceeds 2000 mg/kg bw (read across with ETD-FeNa) LC50 (rat, 4h) exceeded 2.75 +/- 0.19 mg/L, the maximum attainable concentration (read across with EDTA-FeNa). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3efdf9e-c74e-414d-9132-20092707c651/documents/61d9f822-b300-47f7-9089-14f03c130c42_d99a32f7-313d-490b-9d1f-c3ca9f89601e.html,,,,,, Iron(II) oxalate,516-03-0," A 90 days study (OECD 408) was conducted on wistar rat (male/female) to assess the toxicity of oxalic acid via oral route. This study is used in a read across approach to assess the toxicity of iron oxalate. No treatment related effects were observed (e.g. functional observation battery, hematology, clinical biochemistry, adrenals, and thymus). The effects observed were due to species, strain, age, biological variation, incidental, congenital and/or physiology related. No Observed Adverse Effect Level (NOAEL) –  1000 ppm. This value corresponds to 63 mg/kg bw/d, according to calculations ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0b3fbd0-e23c-4199-83fb-a032032df42c/documents/7880873d-aa81-43c4-9d4e-a26adcdc778d_77a2b6d3-e418-497e-81e5-bfc8432f65f2.html,,,,,, Iron(II) oxalate,516-03-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0b3fbd0-e23c-4199-83fb-a032032df42c/documents/7880873d-aa81-43c4-9d4e-a26adcdc778d_77a2b6d3-e418-497e-81e5-bfc8432f65f2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,63 mg/kg bw/day,,rat Iron(II) oxalate,516-03-0, The LD50 of the test item iron oxalate is higher than 2000 mg/ kg body weight by oral route in the rat. The LD50 of the test item iron oxalate is higher than 2000 mg/ kg body weight by dermal route in the rat. The LC50 of the test item iron oxalate is higher than 5mg/L by inhalation route in the rat. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0b3fbd0-e23c-4199-83fb-a032032df42c/documents/5eb52f77-4f31-4b00-810d-208001ff2c23_77a2b6d3-e418-497e-81e5-bfc8432f65f2.html,,,,,, Iron(II) oxalate,516-03-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0b3fbd0-e23c-4199-83fb-a032032df42c/documents/5eb52f77-4f31-4b00-810d-208001ff2c23_77a2b6d3-e418-497e-81e5-bfc8432f65f2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Iron(II) oxalate,516-03-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0b3fbd0-e23c-4199-83fb-a032032df42c/documents/5eb52f77-4f31-4b00-810d-208001ff2c23_77a2b6d3-e418-497e-81e5-bfc8432f65f2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Iron(II) oxalate,516-03-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0b3fbd0-e23c-4199-83fb-a032032df42c/documents/5eb52f77-4f31-4b00-810d-208001ff2c23_77a2b6d3-e418-497e-81e5-bfc8432f65f2.html,,inhalation,LC50,"5,000 mg/m3",, "Iron, complexes with chloroacetic acid-formaldehyde-resorcinol reaction products coupled with 2-hydroxy-3,5-dinitrobenzenediazonium hydroxide inner salt and 4-sulfobenzenediazonium hydroxide inner salt, ammonium sodium salts",85203-82-3, Oral route: LD50 > 2000 mg/kg Inhalation: LC50 > 1.88 mg/l Intraperitoneal route: LD50 > 2000 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d5d7d3d-c588-4f3a-b98b-80c7a77a0a5c/documents/cbecfece-c02d-4291-bfda-780c2676577a_61228815-4a8f-416e-944d-590830bd3892.html,,,,,, "Iron, complexes with diazotized 2-amino-4,6-dinitrophenol coupled with diazotized 4-nitrobenzenamine and 4-[(2,4-dihydroxyphenyl)azo]-5-hydroxy-2,7-naphthalenedisulfonic acid, sodium salts",86014-76-8," analogue substance 1, EU B1, oral, LD50 > 2000 mg/kg analogue substance 2, OECD 401, oral LD50 > 2200 mg/kg other reported studies are with realibilaity 4 and are not used for classification nor for derivation of LD50 parameters ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29c12e74-7abd-4fea-a9db-b39b8d2262a7/documents/0a0a3e91-cbdc-4734-b268-4c32e7b924b7_a2f46269-a444-4b96-90d4-3addb86109b0.html,,,,,, "Iron, complexes with diazotized 2-amino-5-nitrobenzenesulfonic acid coupled with diazotized 2-amino-4-nitrophenol and resorcinol",90412-13-8, Oral route: LD50 > 2000 mg/kg Inhalation: LC50 > 1.88 mg/l Intraperitoneal route: LD50 > 2000 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf348c7a-a884-4867-82f6-255ebe69cd58/documents/1d5c9b29-d0a3-4a3d-b729-88aed8adb63b_f06e3002-6f08-49b5-89a9-1c207e892249.html,,,,,, "Iron, complexes with diazotized 3-amino-2-hydroxy-5-nitrobenzenesulfonic acid monosodium salt coupled with diazotized 2-amino-4-nitrophenol and resorcinol, sodium salts",82640-18-4,"Read-across - the acute toxicity in rats was assessed in a limit test at a dose of 2000 mg/kg by oral route on an analogue substance. Under the experimental conditions reported: - LD0 = 2000 mg/kg- LD50 > 2000 mg/kg   Read-across - the similar substance substance was administered to 5/rat/sex by gavage at dose of 5000 mg/kg. Test animals were observed for 14 days after dosing. Under the experimental conditions reported: - LD0 = 5000 mg/kg- LD50 > 5000 mg/kg   Read-across - a single maximum concentration of test substance was given to 20 rats (10 male, 10 female) as a dust by inhalation (nose only) over a period of 4 hours. A further 10 rats (5 male, 5 female) were exposed under similar conditions to an atmosphere of filtered air. The concentration of test substance measured by gravimetric analysis was 1.88 mg/l.Under the reported experimental conditions, the LC50 > 1.88 mg/l after a 4-hour exposure.   Acute intraperitoneal toxicity was assessed by dosing 5 mice/sex/dose by intraperitoneal route at dose of 2000 mg/kg. Observations were carried out for 14 days after dosing. Under the experimental conditions reported, the LD50 > 2000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71fea289-7ad4-4f4e-ab23-02c8b2d98c80/documents/c759e923-80db-4df5-bbef-6e1ebc7157fb_7045be0f-2dca-465d-a72f-c0f76ff4dd56.html,,,,,, "Iron, complexes with diazotized 3-amino-2-hydroxy-5-nitrobenzenesulfonic acid monosodium salt coupled with diazotized 2-amino-4-nitrophenol and resorcinol, sodium salts",82640-18-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71fea289-7ad4-4f4e-ab23-02c8b2d98c80/documents/c759e923-80db-4df5-bbef-6e1ebc7157fb_7045be0f-2dca-465d-a72f-c0f76ff4dd56.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Iron, complexes with diazotized 3-amino-2-hydroxy-5-nitrobenzenesulfonic acid monosodium salt coupled with diazotized 2-amino-4-nitrophenol and resorcinol, sodium salts",82640-18-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/71fea289-7ad4-4f4e-ab23-02c8b2d98c80/documents/c759e923-80db-4df5-bbef-6e1ebc7157fb_7045be0f-2dca-465d-a72f-c0f76ff4dd56.html,,inhalation,LC50,> 1.88 mg/L,no adverse effect observed, "Iron, complexes with diazotized 5-amino-2-(phenylamino)benzenesulfonic acid monosodium salt coupled with 4-[(2-hydroxy-3,5-dinitrophenyl)azo]-1,3-benzenediol, diazotized 4-nitrobenzenamine and diazotized 3-aminobenzenesulfonic acid monosodium salt",72207-77-3," LD50 (oral, rat) > 5000 mg/kg b.w LD50 (dermal, rat) > 5000 mg/kg b.w ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf91080f-8f0b-44a6-9170-7c5a75da09ff/documents/f043895f-9a19-43c9-9a34-53e7777f1704_50c04f39-a1aa-4d5c-8c4e-cd1c22477c5c.html,,,,,, "Iron, complexes with diazotized 5-amino-2-(phenylamino)benzenesulfonic acid monosodium salt coupled with 4-[(2-hydroxy-3,5-dinitrophenyl)azo]-1,3-benzenediol, diazotized 4-nitrobenzenamine and diazotized 3-aminobenzenesulfonic acid monosodium salt",72207-77-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf91080f-8f0b-44a6-9170-7c5a75da09ff/documents/f043895f-9a19-43c9-9a34-53e7777f1704_50c04f39-a1aa-4d5c-8c4e-cd1c22477c5c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Iron, complexes with diazotized 5-amino-2-(phenylamino)benzenesulfonic acid monosodium salt coupled with 4-[(2-hydroxy-3,5-dinitrophenyl)azo]-1,3-benzenediol, diazotized 4-nitrobenzenamine and diazotized 3-aminobenzenesulfonic acid monosodium salt",72207-77-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf91080f-8f0b-44a6-9170-7c5a75da09ff/documents/f043895f-9a19-43c9-9a34-53e7777f1704_50c04f39-a1aa-4d5c-8c4e-cd1c22477c5c.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Isobutyl acrylate,106-63-8,"NOAEC = 60 ppm (equivalent to 0.319 mg/L) (Wistar rat, vapour inhalation, OECD TG 413, 422)The inhalation of 180 ppm tert-butyl acrylate vapours (equivalent to 0.956 mg/L) by male and female Wistar rats in a combined sub-chronic toxicity study with a reproduction / developmental toxicity screening test (OECD TG 413/ 422) caused slight irritation of the eyes and upper respiratory tract, retarded body weight development, mild impairment of renal function in the males, a reduced general health status and two deaths during gestation in the females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/597664f8-96c1-4573-9595-9cb10985c8ad/documents/dc008ef3-4441-49da-8473-61fb00ff9d4e_6f46d01f-26a6-4c1d-ab5d-053cfacd9e18.html,,,,,, Isobutyl acrylate,106-63-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/597664f8-96c1-4573-9595-9cb10985c8ad/documents/dc008ef3-4441-49da-8473-61fb00ff9d4e_6f46d01f-26a6-4c1d-ab5d-053cfacd9e18.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,319 mg/m3,,rat Isobutyl acrylate,106-63-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/597664f8-96c1-4573-9595-9cb10985c8ad/documents/dc008ef3-4441-49da-8473-61fb00ff9d4e_6f46d01f-26a6-4c1d-ab5d-053cfacd9e18.html,Repeated dose toxicity – local effects,inhalation,NOAEC,319 mg/m3,adverse effect observed,rat Isobutyl acrylate,106-63-8,"Oral: LD50 = 4895 mg/kg bw (rat) (BASF, 1962)Inhalation: LC50 = 10.5 mg/L (rat, 4h) (Union Carbide, 1968)Dermal: LD50 >2000 mg/kg bw (rabbit, occlusive) (BASF Corp., 1998 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/597664f8-96c1-4573-9595-9cb10985c8ad/documents/IUC5-f3affc92-917e-473c-8a59-de5013d30803_6f46d01f-26a6-4c1d-ab5d-053cfacd9e18.html,,,,,, Isobutyl acrylate,106-63-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/597664f8-96c1-4573-9595-9cb10985c8ad/documents/IUC5-f3affc92-917e-473c-8a59-de5013d30803_6f46d01f-26a6-4c1d-ab5d-053cfacd9e18.html,,oral,LD50,"4,895 mg/kg bw",no adverse effect observed, Isobutyl acrylate,106-63-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/597664f8-96c1-4573-9595-9cb10985c8ad/documents/IUC5-f3affc92-917e-473c-8a59-de5013d30803_6f46d01f-26a6-4c1d-ab5d-053cfacd9e18.html,,dermal,LD50,"> 2,000 mg/kg bw",adverse effect observed, Isobutyl acrylate,106-63-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/597664f8-96c1-4573-9595-9cb10985c8ad/documents/IUC5-f3affc92-917e-473c-8a59-de5013d30803_6f46d01f-26a6-4c1d-ab5d-053cfacd9e18.html,,inhalation,LC50,"10,500 mg/m3",adverse effect observed, Isobutyl laurate,37811-72-6,"Repeated dose toxicity, oral (OECD 407), rat: NOAEL =1000 mg/kg bw/day (RA CAS 110-27-0) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ea335db-1e69-4a3a-8b08-8e1e506f9f87/documents/ad5bbc28-1b66-449c-b09b-d873b2c7dd5f_f6f302d6-2bb3-4f6a-a6ba-840c7ccac751.html,,,,,, Isobutyl laurate,37811-72-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ea335db-1e69-4a3a-8b08-8e1e506f9f87/documents/ad5bbc28-1b66-449c-b09b-d873b2c7dd5f_f6f302d6-2bb3-4f6a-a6ba-840c7ccac751.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Isobutyl laurate,37811-72-6,"Oral (WoE): LD50 (OECD 401), rat >2000 mg/kg bw (RA CAS 110-27-0); LD50 (OECD 401), mouse >5000 mg/kg bw (RA CAS 646-13-9)Inhalation LC50 (OECD 436), rat >5.3 mg/L air (RA CAS 10233-13-3)Dermal LD50 (OECD 402), rat >2000 mg/kg bw (RA CAS 163961-32-8) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ea335db-1e69-4a3a-8b08-8e1e506f9f87/documents/6cc34b69-3755-422a-b69e-9f1ff18222d0_f6f302d6-2bb3-4f6a-a6ba-840c7ccac751.html,,,,,, Isobutyl vinyl ether,109-53-5,No data are available on the oral or dermal route of exposure (inhalation exposure is considered to be the predominant route of exposure).In a sub-acute inhalation study in pregnant rats local effects in the nasal cacity were found even at the lowest dose tested (500 ppm or 2080 mg/m³). At 2000 ppm (8300 mg/m³) adaptive effects due to increased metabolism (increased liver weight) or alterations secondary to the local effects were detected. Clinical signs and reduced body weight were only detected at 8000 ppm (33200 mg/m³).After subchronic inhalation exposure in rats local effects in the nasal cavity were found as well as adaptive effects in liver and kidney (increased metabolism of the test substance; no histopathological effects) at a concentration of >= 500 ppm (2080 mg/m³); the NOAEC was 50 ppm (208 mg/m³). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c9b0be6-13c6-4cb6-893e-d6952c6f9e53/documents/eec38dc1-bff3-41eb-8777-ebda6af8403b_688b6fd1-83a2-4b4a-b596-4c3be93d6f98.html,,,,,, Isobutyl vinyl ether,109-53-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c9b0be6-13c6-4cb6-893e-d6952c6f9e53/documents/eec38dc1-bff3-41eb-8777-ebda6af8403b_688b6fd1-83a2-4b4a-b596-4c3be93d6f98.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,208 mg/m3,,rat Isobutyl vinyl ether,109-53-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c9b0be6-13c6-4cb6-893e-d6952c6f9e53/documents/eec38dc1-bff3-41eb-8777-ebda6af8403b_688b6fd1-83a2-4b4a-b596-4c3be93d6f98.html,Repeated dose toxicity – local effects,inhalation,NOAEC,208 mg/m3,adverse effect observed,rat Isobutyl vinyl ether,109-53-5,The oral LD50 in rats was >7700 mg/kg bw.The dermal LD50 in rabbits was 15400 mg/kg bw.In acute inhalation studies in rats the LC50 (4 h) was > 21000 mg/m³. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c9b0be6-13c6-4cb6-893e-d6952c6f9e53/documents/a4d019a9-1b24-4c56-b023-8c9c12f2f225_688b6fd1-83a2-4b4a-b596-4c3be93d6f98.html,,,,,, Isobutyl vinyl ether,109-53-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c9b0be6-13c6-4cb6-893e-d6952c6f9e53/documents/a4d019a9-1b24-4c56-b023-8c9c12f2f225_688b6fd1-83a2-4b4a-b596-4c3be93d6f98.html,,dermal,LD50,"15,400 mg/kg bw",no adverse effect observed, Isobutyldimethoxymethylsilane,18293-82-8,"In key acute oral and inhalation studies conducted according to appropriate guidelines and in compliance with GLP on read-across substance isobutyl(trimethoxy)silane, the LD50 (oral) was found to be > 2000 mg/kg bw and the LC50 (inhalation, 4 hour) was found to be > 11000 mg/m3. These data are read across to isobutyl(dimethoxy)methylsilane. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8df3cdb9-e7a8-4141-9317-1089ecdf435f/documents/IUC5-e0da61df-c742-454e-9852-2a425cd1d9fc_f81543d2-a1d5-472a-831d-09df271f2c5b.html,,,,,, Isobutyldimethoxymethylsilane,18293-82-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8df3cdb9-e7a8-4141-9317-1089ecdf435f/documents/IUC5-e0da61df-c742-454e-9852-2a425cd1d9fc_f81543d2-a1d5-472a-831d-09df271f2c5b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Isobutyldimethoxymethylsilane,18293-82-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8df3cdb9-e7a8-4141-9317-1089ecdf435f/documents/IUC5-e0da61df-c742-454e-9852-2a425cd1d9fc_f81543d2-a1d5-472a-831d-09df271f2c5b.html,,inhalation,LC50,"11,000 mg/m3",no adverse effect observed, Isobutylisopropyldimethoxysilane,111439-76-0,"The test substance was evaluated in a 28 day oral repeated dose toxicity study in the rat (OECD Guideline 407). Effects on the kidneys were observed in male rats, however, this was considered a species specific effect, which is not relevant to humans. The NOAEL for female rats was 1000 mg/kg bw/day.An oral 90 day repeated dose toxicity study was conducted with the test substance in the rat (OECD Guideline 407) at the following doses: 5, 20, 100, 1000 mg/kg bw/day. Limited data are available regarding this study. The NOAEL for female rats was 100 mg/kg bw/day (however, the basis for selecting this dose as the NOAEL is not available). The NOAEL for male rats was 20 mg/kg bw/day based on adverse effects on the kidneys; this was considered a species specific effect, which is not relevant to humans. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f4f0e6c-439c-4e08-80ea-e4fe877763ad/documents/IUC5-ce89237e-efda-4b22-9929-7ae69c57f67c_5c6f0510-5366-4be0-ae82-871bf901cb90.html,,,,,, Isobutylisopropyldimethoxysilane,111439-76-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f4f0e6c-439c-4e08-80ea-e4fe877763ad/documents/IUC5-ce89237e-efda-4b22-9929-7ae69c57f67c_5c6f0510-5366-4be0-ae82-871bf901cb90.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Isobutylisopropyldimethoxysilane,111439-76-0,The test substance is classified as Acute Toxicity Category 4 by the inhalation route. It is not classified for acute toxicity by the oral route or by the dermal route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f4f0e6c-439c-4e08-80ea-e4fe877763ad/documents/IUC5-6a325e3f-ae95-42cf-b9bd-bfa58cd7b864_5c6f0510-5366-4be0-ae82-871bf901cb90.html,,,,,, Isobutylisopropyldimethoxysilane,111439-76-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f4f0e6c-439c-4e08-80ea-e4fe877763ad/documents/IUC5-6a325e3f-ae95-42cf-b9bd-bfa58cd7b864_5c6f0510-5366-4be0-ae82-871bf901cb90.html,,oral,LD50,"2,180 mg/kg bw",no adverse effect observed, Isobutylisopropyldimethoxysilane,111439-76-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f4f0e6c-439c-4e08-80ea-e4fe877763ad/documents/IUC5-6a325e3f-ae95-42cf-b9bd-bfa58cd7b864_5c6f0510-5366-4be0-ae82-871bf901cb90.html,,dermal,LD50,"2,180 mg/kg bw",no adverse effect observed, Isobutylisopropyldimethoxysilane,111439-76-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f4f0e6c-439c-4e08-80ea-e4fe877763ad/documents/IUC5-6a325e3f-ae95-42cf-b9bd-bfa58cd7b864_5c6f0510-5366-4be0-ae82-871bf901cb90.html,,inhalation,LC50,"4,000 mg/m3",no adverse effect observed, Isobutyric anhydride,97-72-3,"For isobutyric anhydride, no data on repeated dose toxicity could be located.To compensate for this lack of data, information resulting from isobutanol and isobutyl isobutyrate as supporting substances will be used as substitute. Data are available for oral and inhalation repeated dose toxicity. Repeated dose toxicity: oral (gavage) Supporting substance isobutanol: Similar to OECD TG 408, GLP, 90 d, rat, 0, 100, 316, 1000 mg/kg bw/day, Results: NOEL = 316 mg/kg bw/day.  The NOEL for isobutyric acid (conversion using the respective molecular weights) is ca. 375 mg/kg bw/day.  The NOEL for isobutyric anhydride (conversion using the respective molecular weights and a correction factor of 2 as two isobutyric acid moieties are present in one molecule of isobutyric anhydride) is ca. 337.2209 mg/kg bw/day.    Supporting substance isobutyl isobutyrate: In a valid subchronic (90 d) toxicity studies, a NOAEL of 1000 mg/kg bw/day has been observed (Drake 1978).The NOAEL for isobutyric acid (conversion using the respective molecular weights) is ca. 610 mg/kg bw/day The NOAEL for isobutyric anhydride (conversion using the respective molecular weights and a correction factor of 2 as two isobutyric acid moieties are present in one molecule of isobutyric anhydride) is ca. 548.4883 mg/kg bw/day.    Repeated dose toxicity: inhalationSupporting substance isobutanol: In a valid subchronic (90 d) toxicity study, the NOAEL was derived to be 7700 mg/m³ (Li/Monsanto 1999).The NOAEC for isobutyric acid(conversion using the respective molecular weights) is ca. 9150 mg/m³. The NOAEC for isobutyric anhydride (conversion using the respective molecular weights and a correction factor of 2 as two isobutyric acid moieties are present in one molecule of isobutyric anhydride) is ca. 8217.09 mg/m³.    The findings of all three studies do not indicate a specific target organ. Note that the effect level of the 90-day oral study was reported out as a NOEL rather than a NOAEL. There is no NOEL selection or free text box in this area. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44ce8af2-e3dd-468d-aad7-df168abc5778/documents/IUC5-af1c8ea4-f863-4d21-b5f2-5beec3003f99_c56f29e2-89f9-479c-9250-06df713ba616.html,,,,,, Isobutyric anhydride,97-72-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44ce8af2-e3dd-468d-aad7-df168abc5778/documents/IUC5-af1c8ea4-f863-4d21-b5f2-5beec3003f99_c56f29e2-89f9-479c-9250-06df713ba616.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,337.221 mg/kg bw/day,,rat Isobutyric anhydride,97-72-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44ce8af2-e3dd-468d-aad7-df168abc5778/documents/IUC5-af1c8ea4-f863-4d21-b5f2-5beec3003f99_c56f29e2-89f9-479c-9250-06df713ba616.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"8,217.09 mg/m3",,rat Isobutyric anhydride,97-72-3,"The oral LD50 of butyric anhydride was determined to be 7700 mg/kg bw in rats. Supporting data from the acid hydrolysis product confirmed an LD50 > 2 g/kg in 2 reliable studies. A third study reporting an LD50 value an order of magnitude lower for the acid is available, but it is of lower quality than the other studies and does not provide the full experimental results or study data.In an Inhalation Hazard Test similar to OECD TG 403, mortality was observed in a saturated atmosphere (~ 4.21 mg/L) at both 3 and 7 hours of exposure. The LC50 was 4.21 mg/L (after 7 hours of exposure). No dermal toxicity data was available for isobutyric anhydride. The dermal LD50 of isobutyric acid was determined to be 474 mg/kg in male rabbits (Smyth, 1962). As excess water is required for full hydrolysis to the acid, the results for the acid should be considered a worst-case. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44ce8af2-e3dd-468d-aad7-df168abc5778/documents/IUC5-eb987080-c33f-44bb-bd14-db532378f0a6_c56f29e2-89f9-479c-9250-06df713ba616.html,,,,,, Isobutyric anhydride,97-72-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44ce8af2-e3dd-468d-aad7-df168abc5778/documents/IUC5-eb987080-c33f-44bb-bd14-db532378f0a6_c56f29e2-89f9-479c-9250-06df713ba616.html,,oral,LD50,"7,700 mg/kg bw",no adverse effect observed, Isobutyric anhydride,97-72-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44ce8af2-e3dd-468d-aad7-df168abc5778/documents/IUC5-eb987080-c33f-44bb-bd14-db532378f0a6_c56f29e2-89f9-479c-9250-06df713ba616.html,,dermal,LD50,474 mg/kg bw,adverse effect observed, Isobutyric anhydride,97-72-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44ce8af2-e3dd-468d-aad7-df168abc5778/documents/IUC5-eb987080-c33f-44bb-bd14-db532378f0a6_c56f29e2-89f9-479c-9250-06df713ba616.html,,inhalation,LC50,"4,210 mg/m3",adverse effect observed, Isobutyrophenone,611-70-1,The median lethal dose (LD50) was 2167 mg/kg for both sexes ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60de53c8-fc4f-4a06-a71d-4a12706896c9/documents/IUC5-2f964770-7d46-4bae-8b03-cac011282fcd_7a36ec8c-be8e-4d72-ad8b-8a4c9ad6c6f8.html,,,,,, Isobutyrophenone,611-70-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60de53c8-fc4f-4a06-a71d-4a12706896c9/documents/IUC5-2f964770-7d46-4bae-8b03-cac011282fcd_7a36ec8c-be8e-4d72-ad8b-8a4c9ad6c6f8.html,,oral,LD50,"2,000 mg/kg bw",, Isobutyryl chloride,79-30-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Standard acute method, similar to OECD Guideline 401 (Acute Oral Toxicity), 1981 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): OECD Guideline 403 (Acute Inhalation Toxicity), 1989 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): OECD Guideline 402 (Acute Dermal Toxicity), 1981 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a746f0f-618b-40ea-b0e1-4ed1a5693031/documents/53b31959-4434-4c3b-bc16-eb2979130dd2_830a0a86-f1e6-4901-92ff-a207f075945b.html,,,,,, Isobutyryl chloride,79-30-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a746f0f-618b-40ea-b0e1-4ed1a5693031/documents/53b31959-4434-4c3b-bc16-eb2979130dd2_830a0a86-f1e6-4901-92ff-a207f075945b.html,,oral,LD50,"ca.1,000 mg/kg bw",adverse effect observed, Isobutyryl chloride,79-30-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a746f0f-618b-40ea-b0e1-4ed1a5693031/documents/53b31959-4434-4c3b-bc16-eb2979130dd2_830a0a86-f1e6-4901-92ff-a207f075945b.html,,dermal,LD50,"ca.2,000 mg/kg bw",no adverse effect observed, Isobutyryl chloride,79-30-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a746f0f-618b-40ea-b0e1-4ed1a5693031/documents/53b31959-4434-4c3b-bc16-eb2979130dd2_830a0a86-f1e6-4901-92ff-a207f075945b.html,,inhalation,LC50,0.47 mg/L,adverse effect observed, Isodecyl diphenyl phosphate,29761-21-5,Oral 90-d repeated dose toxicity study: LOAEL 10 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b38faa6-3eeb-4989-b58d-10e1b2d8ba72/documents/IUC5-9b074d0e-5c9f-4aea-967c-ab97c847ed5e_86ead645-16d4-4010-8b0a-0eab2bf1cefc.html,,,,,, Isodecyl diphenyl phosphate,29761-21-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b38faa6-3eeb-4989-b58d-10e1b2d8ba72/documents/IUC5-9b074d0e-5c9f-4aea-967c-ab97c847ed5e_86ead645-16d4-4010-8b0a-0eab2bf1cefc.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,10 mg/kg bw/day,,rat Isodecyl diphenyl phosphate,29761-21-5,"Acute oral toxicity:2 Weight of Evidence (WoE) tests: Acute toxic class method (no guideline followed): LD50 > 15800 and LD50 > 7940 mg/kg bw (male/female rat).Acute dermal toxicity:Standard acute method, Limit test (similar to OECD 402): LD50 > 2010 mg/kg bw (male/female rabbit).Acute inhalation toxicity:Standard acute method, Limit test (similar to OECD 403): LC0, 4h = 6.3 mg/L air (analytical) (aerosol; male/female rat). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b38faa6-3eeb-4989-b58d-10e1b2d8ba72/documents/IUC5-ca1c44ca-7b08-4f4f-92bf-edcfe0080536_86ead645-16d4-4010-8b0a-0eab2bf1cefc.html,,,,,, Isodecyl diphenyl phosphate,29761-21-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b38faa6-3eeb-4989-b58d-10e1b2d8ba72/documents/IUC5-ca1c44ca-7b08-4f4f-92bf-edcfe0080536_86ead645-16d4-4010-8b0a-0eab2bf1cefc.html,,oral,LD50,"7,940 mg/kg bw",, Isodecyl diphenyl phosphate,29761-21-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b38faa6-3eeb-4989-b58d-10e1b2d8ba72/documents/IUC5-ca1c44ca-7b08-4f4f-92bf-edcfe0080536_86ead645-16d4-4010-8b0a-0eab2bf1cefc.html,,dermal,LD50,"2,010 mg/kg bw",, Isodecyl diphenyl phosphate,29761-21-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b38faa6-3eeb-4989-b58d-10e1b2d8ba72/documents/IUC5-ca1c44ca-7b08-4f4f-92bf-edcfe0080536_86ead645-16d4-4010-8b0a-0eab2bf1cefc.html,,inhalation,LC50,"6,300 mg/m3",, Isodecyl methacrylate,29964-84-9,"Results of the repeated dose studies on the structurally closely related esters 2-Ethylhexyl methacrylate (C8-Ester) and Dodecyl methacrylate (C12-Ester) are considered as representative for the repeated dose toxicity of Isodecyl methacrylate (C10-Ester).In an OECD 422 GLP study with Dodecyl methacrylate in rats, there was no evidence for toxicity up to the highest administered dose. The NOAEL was 1000 mg/kg/d. In a fully valid 90 d OECD 408 GLP study with 2-Ethylhexyl methacrylate, the NOAEL was 120 mg/kg body weight/day in rats.Taken as a whole there are sufficient data available for assessment purposes so for the sake of animal welfare it is not proposed to conduct further repeated dose studies. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26f4e7f0-22bc-4dac-9734-e11bacb3b6fc/documents/98e23e5a-1cff-41c7-9b2b-a4cb1cd54a3d_765753b5-019f-4881-a6b4-7030d3945cd0.html,,,,,, Isodecyl methacrylate,29964-84-9,"The acute toxicity of Isodecyl methacrylate was demonstrated to be low by the oral and dermal route. The absence of inhalation toxicity was demonstrated in a study where test animals were exposed to a saturated atmosphere. However, the inhalation route is not of relevance due to the low vapour pressure of the substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26f4e7f0-22bc-4dac-9734-e11bacb3b6fc/documents/3437454b-ae8e-4ad0-9db6-824ceb071726_765753b5-019f-4881-a6b4-7030d3945cd0.html,,,,,, Isodecyl methacrylate,29964-84-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26f4e7f0-22bc-4dac-9734-e11bacb3b6fc/documents/3437454b-ae8e-4ad0-9db6-824ceb071726_765753b5-019f-4881-a6b4-7030d3945cd0.html,,oral,LD50,"5,000 mg/kg bw",, Isodecyl methacrylate,29964-84-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26f4e7f0-22bc-4dac-9734-e11bacb3b6fc/documents/3437454b-ae8e-4ad0-9db6-824ceb071726_765753b5-019f-4881-a6b4-7030d3945cd0.html,,dermal,LD50,"3,000 mg/kg bw",, Isoheptane,31394-54-4, Inhalation Inhalation systemic NOAEC (Rat): 12470 mg/m3 ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/694ec57f-feb2-4d63-ab10-34d2468b29a1/documents/e94d3426-054b-4390-bd0c-21230bfa382f_0be6af71-16f2-4942-8889-d3bcd1d650be.html,,,,,, Isoheptane,31394-54-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/694ec57f-feb2-4d63-ab10-34d2468b29a1/documents/e94d3426-054b-4390-bd0c-21230bfa382f_0be6af71-16f2-4942-8889-d3bcd1d650be.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"12,470 mg/m3",,rat Isoheptane,31394-54-4, Oral LD50 (rat) >5000 mg/Kg bw Inhalative LC50 (rat) >33520 mg/m³ Dermal LD50 (rabbit) >2000 mg/Kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/694ec57f-feb2-4d63-ab10-34d2468b29a1/documents/8189344d-90d9-408d-a5bb-6ca4f05dfa72_0be6af71-16f2-4942-8889-d3bcd1d650be.html,,,,,, Isoheptane,31394-54-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/694ec57f-feb2-4d63-ab10-34d2468b29a1/documents/8189344d-90d9-408d-a5bb-6ca4f05dfa72_0be6af71-16f2-4942-8889-d3bcd1d650be.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Isoheptane,31394-54-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/694ec57f-feb2-4d63-ab10-34d2468b29a1/documents/8189344d-90d9-408d-a5bb-6ca4f05dfa72_0be6af71-16f2-4942-8889-d3bcd1d650be.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Isoheptane,31394-54-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/694ec57f-feb2-4d63-ab10-34d2468b29a1/documents/8189344d-90d9-408d-a5bb-6ca4f05dfa72_0be6af71-16f2-4942-8889-d3bcd1d650be.html,,inhalation,LC50,"> 33,520 mg/m3",no adverse effect observed, "Reaction mass of (2R,3R)-2-(hexadecanoylamino)-3-methylpentanoic acid and (2S,3S)-2-(hexadecanoylamino)-3-methylpentanoic acid",101541-04-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Oral acute toxicity tests were performed on analogues substances (lipoaminoacids) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b5f3faa-730c-40f6-84b8-b72106f9965e/documents/IUC5-8970df0a-dcf7-4738-aa5d-22d520df440e_34e4c23d-562f-44b9-bb50-1f37b77f28dc.html,,,,,, "Reaction mass of (2R,3R)-2-(hexadecanoylamino)-3-methylpentanoic acid and (2S,3S)-2-(hexadecanoylamino)-3-methylpentanoic acid",101541-04-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b5f3faa-730c-40f6-84b8-b72106f9965e/documents/IUC5-8970df0a-dcf7-4738-aa5d-22d520df440e_34e4c23d-562f-44b9-bb50-1f37b77f28dc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Isooctadecanoic acid, mono- and diesters with glycerol",97358-80-0,"All available subacute, subchronic and chronic repeated dose toxicity studies resulted in NOAELs ≥ 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43177e26-d7c1-4424-98a5-da8853f248ba/documents/IUC5-7e830d6c-ab5b-4425-9d8c-3705dc9a9963_e96f9d0c-8235-4efe-b68f-d51b0435787b.html,,,,,, "Isooctadecanoic acid, mono- and diesters with glycerol",97358-80-0,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 1.86 mg/L air (maximum attainable concentration of respirable particles). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43177e26-d7c1-4424-98a5-da8853f248ba/documents/IUC5-7c4b169a-9f50-4027-9f6e-508c1374a628_e96f9d0c-8235-4efe-b68f-d51b0435787b.html,,,,,, Isooctane,26635-64-3, Repeated Dose Inhalation 90d – NOAEC = 24300 mg/m3 (6646 ppm) for rats (similar to OECD TG 413) ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/16a3e19e-b6a9-40dd-ac2a-c23f77152b4d/documents/a0334c77-00aa-410e-a4f5-98e70b1d3d17_30668717-fd66-4561-9cc5-4dae62a478a4.html,,,,,, Isooctane,26635-64-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/16a3e19e-b6a9-40dd-ac2a-c23f77152b4d/documents/a0334c77-00aa-410e-a4f5-98e70b1d3d17_30668717-fd66-4561-9cc5-4dae62a478a4.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"24,300 mg/m3",,rat Isooctane,26635-64-3, Acute toxicity oral LD50 >5000 mg/kg bw in rats (OECD TG 401) Acute toxicity dermal LD50 >2000 mg/kg bw in rabbits (OECD TG 402) Acute toxicity inhalation LC50 >33520 mg/m³ in rats (OECD TG 403) ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16a3e19e-b6a9-40dd-ac2a-c23f77152b4d/documents/2782c286-3bf6-4927-9fe8-d7753380afde_30668717-fd66-4561-9cc5-4dae62a478a4.html,,,,,, Isooctane,26635-64-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16a3e19e-b6a9-40dd-ac2a-c23f77152b4d/documents/2782c286-3bf6-4927-9fe8-d7753380afde_30668717-fd66-4561-9cc5-4dae62a478a4.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Isooctane,26635-64-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16a3e19e-b6a9-40dd-ac2a-c23f77152b4d/documents/2782c286-3bf6-4927-9fe8-d7753380afde_30668717-fd66-4561-9cc5-4dae62a478a4.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Isooctane,26635-64-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16a3e19e-b6a9-40dd-ac2a-c23f77152b4d/documents/2782c286-3bf6-4927-9fe8-d7753380afde_30668717-fd66-4561-9cc5-4dae62a478a4.html,,inhalation,LC50,"> 33,520 mg/m3",no adverse effect observed, Isooctene,11071-47-9,"The 90-day inhalation exposure of rats to Isooctene at 1000, 5000 and 15000 mg/m3 induced toxicity in the male kidney (target organ), effects in the male liver, but no effects in the respiratory tract. The male rat-specific kidney effects are indicative of alpha-2u-globulin nephropathy and are not considered relevant to humans.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfc04324-3876-4bdf-901c-a337d04ddbc7/documents/IUC5-5013b5c3-ae82-4b9e-a0c9-ab16000020d8_30bddce7-9ab1-4e04-8e95-cea3adc8bb61.html,,,,,, Isooctene,11071-47-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfc04324-3876-4bdf-901c-a337d04ddbc7/documents/IUC5-5013b5c3-ae82-4b9e-a0c9-ab16000020d8_30bddce7-9ab1-4e04-8e95-cea3adc8bb61.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat Isooctene,11071-47-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfc04324-3876-4bdf-901c-a337d04ddbc7/documents/IUC5-5013b5c3-ae82-4b9e-a0c9-ab16000020d8_30bddce7-9ab1-4e04-8e95-cea3adc8bb61.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"15,000 mg/m3",no adverse effect observed,rat Isooctene,11071-47-9,"In an oral limit dose toxicity test, there were no deaths in rats following a single dose of 10,000 mg/kg isooctene. No data are available for acute toxicity of isooctene via dermal and inhalation routes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfc04324-3876-4bdf-901c-a337d04ddbc7/documents/IUC5-20e300b1-4dd9-41ab-bfdf-48f8d2ad586a_30bddce7-9ab1-4e04-8e95-cea3adc8bb61.html,,,,,, Isooctyl 3-mercaptopropionate,30374-01-7,IOMP is harmful via the oral route. IOMP is non-toxic via dermal and inhalation route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c871ac8-3344-4b88-9277-1bdc19a0f662/documents/IUC5-017b35af-96f0-4839-a229-1d732f9ea42a_66fc6e7b-d429-4fbf-be3a-790049d5d38f.html,,,,,, Isooctyl 3-mercaptopropionate,30374-01-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c871ac8-3344-4b88-9277-1bdc19a0f662/documents/IUC5-017b35af-96f0-4839-a229-1d732f9ea42a_66fc6e7b-d429-4fbf-be3a-790049d5d38f.html,,oral,LD50,674 mg/kg bw,adverse effect observed, Isooctyl 3-mercaptopropionate,30374-01-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c871ac8-3344-4b88-9277-1bdc19a0f662/documents/IUC5-017b35af-96f0-4839-a229-1d732f9ea42a_66fc6e7b-d429-4fbf-be3a-790049d5d38f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Isooctyl acrylate,29590-42-9,"Two Repeat Dose studies, a 28-Day Oral and a 90-Day Oral, have been conducted on IOA.28-Day Oral NOAEL: 1000 mg/kg90-Day Oral NOAEL: 600 mg/kg ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79565167-27dc-4163-b511-c3ffc9a4c28f/documents/IUC5-144138e9-cafb-4571-8415-d85036226903_b6db5ffe-517a-47c0-9aba-f5ed5e3a6ea5.html,,,,,, Isopentyl oleate,627-89-4,"Repeated dose toxicity, oral (OECD 407), rat: NOAEL =1000 mg/kg bw/day (RA CAS 110-27-0) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a93ef0c-7ac2-4768-a7f9-191052bc1352/documents/2d4c5ae9-3e38-4882-a45c-f34b9cb5c55c_26cb11a7-4bd4-4bc1-a885-557b5c96bd0e.html,,,,,, Isopentyl oleate,627-89-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a93ef0c-7ac2-4768-a7f9-191052bc1352/documents/2d4c5ae9-3e38-4882-a45c-f34b9cb5c55c_26cb11a7-4bd4-4bc1-a885-557b5c96bd0e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Isopentyl oleate,627-89-4,"Oral (WoE): LD50 (OECD 401), rat >2000 mg/kg bw (RA CAS 84988-79-4); LD50 (OECD 423), rat >2000 mg/kg bw (RA CAS 112-11-8)Inhalation (WoE): LC50 (OECD 436), rat >5.7 mg/L air (RA CAS 26399-02-0); LC50 (OECD 436), rat >5.3 mg/L air (RA CAS 67762-63-4)Dermal LD50 (OECD 402), rat >2000 mg/kg bw (RA CAS 163961-32-8) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a93ef0c-7ac2-4768-a7f9-191052bc1352/documents/52c472db-c310-43d6-b4a6-1bc8d1992ccb_26cb11a7-4bd4-4bc1-a885-557b5c96bd0e.html,,,,,, Isopentylamine,107-85-7,"In valid acute toxicity rat studies, the LD50 was 341 and 427 mg/kg bw (oral) and 2000 mg/kg bw (dermal), respectively. The inhalation LC50(rat, 4 hr) was 11,500 mg/m³. Toxicity and mortality was closely related to the corrosivity of isopentylamine on either route of exposure. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32495393-aa8f-4d89-8034-4a5b86456681/documents/IUC5-7cfeb738-8db4-4ecb-a07e-7a4a48f72c02_bd309376-2176-4437-b21e-917c68bfb570.html,,,,,, Isopentylamine,107-85-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32495393-aa8f-4d89-8034-4a5b86456681/documents/IUC5-7cfeb738-8db4-4ecb-a07e-7a4a48f72c02_bd309376-2176-4437-b21e-917c68bfb570.html,,oral,LD50,341 mg/kg bw,, Isopentylamine,107-85-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32495393-aa8f-4d89-8034-4a5b86456681/documents/IUC5-7cfeb738-8db4-4ecb-a07e-7a4a48f72c02_bd309376-2176-4437-b21e-917c68bfb570.html,,dermal,LD50,"2,000 mg/kg bw",, Isopentylamine,107-85-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32495393-aa8f-4d89-8034-4a5b86456681/documents/IUC5-7cfeb738-8db4-4ecb-a07e-7a4a48f72c02_bd309376-2176-4437-b21e-917c68bfb570.html,,inhalation,LC50,"11,500 mg/m3",, Isophthaloyl dichloride,99-63-8, Oral: NOAEL; OECD 408; 90-day rat; feed; small increases in the incidence of crystalluria and renal pathology (mild hydronephrosis and pelvic calcification) were observed in the two higher dose groups (≥ 1405 mg/kg bw/day); reliability = 2. [CAS# 121-91-5] Dermal: Testing has been waived due to exposure considerations. Inhalation: Testing has been waived due to exposure considerations. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8f7bcfe-206d-4ed7-b7ce-f7962a70968b/documents/IUC5-0b8e9149-0647-493d-bbfb-5a5da11e7588_a695d425-cc6a-4689-8a24-96f3cb7c104d.html,,,,,, Isophthaloyl dichloride,99-63-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8f7bcfe-206d-4ed7-b7ce-f7962a70968b/documents/IUC5-0b8e9149-0647-493d-bbfb-5a5da11e7588_a695d425-cc6a-4689-8a24-96f3cb7c104d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,447 mg/kg bw/day,, Isophthaloyl dichloride,99-63-8,Oral: ALD; rat; gavage; reliability = 2; NOT CLASSIFIED.Dermal: LD50; rabbit; reliability = 2; CLASSIFIED: Cat 4.Inhalation: 4-hr LC50; rat; reliability = 2; CLASSIFIED: Cat 3; [CAS# 100-20-9]. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8f7bcfe-206d-4ed7-b7ce-f7962a70968b/documents/IUC5-3bca61db-7f22-411a-ac81-4a41ba019e62_a695d425-cc6a-4689-8a24-96f3cb7c104d.html,,,,,, Isophthaloyl dichloride,99-63-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8f7bcfe-206d-4ed7-b7ce-f7962a70968b/documents/IUC5-3bca61db-7f22-411a-ac81-4a41ba019e62_a695d425-cc6a-4689-8a24-96f3cb7c104d.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Isophthaloyl dichloride,99-63-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8f7bcfe-206d-4ed7-b7ce-f7962a70968b/documents/IUC5-3bca61db-7f22-411a-ac81-4a41ba019e62_a695d425-cc6a-4689-8a24-96f3cb7c104d.html,,dermal,LD50,"1,410 mg/kg bw",adverse effect observed, Isophthaloyl dichloride,99-63-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8f7bcfe-206d-4ed7-b7ce-f7962a70968b/documents/IUC5-3bca61db-7f22-411a-ac81-4a41ba019e62_a695d425-cc6a-4689-8a24-96f3cb7c104d.html,,inhalation,LC50,700 mg/m3,adverse effect observed, Isopropenyl acetate,108-22-5,The No Observed Adverse Effect Concentration (NOAEC) for systemic toxicity under the condition of a 28 days inhalative study was 2075 mg/m3 (500 ppm). The NOAEC for hyperplasia of nasal transitional and degeneration of olfactory epithelium was 830 mg/m3(200 ppm). A NOAEC for slight irritancy leading to nasal epithelial inflammatory cell infiltration in some ofthe animals could not be established. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5835d3df-cbf4-4bda-82fa-399aff6c243f/documents/IUC5-c8578940-edbf-4159-82f7-545475b4cf0a_94f18b9b-5c1b-48bc-be6d-9f40a998a8fe.html,,,,,, Isopropenyl acetate,108-22-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5835d3df-cbf4-4bda-82fa-399aff6c243f/documents/IUC5-c8578940-edbf-4159-82f7-545475b4cf0a_94f18b9b-5c1b-48bc-be6d-9f40a998a8fe.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,830 mg/m3,, Isopropenyl acetate,108-22-5,"Isopropenyl acetate is relatively harmless if administered orally,dermally or via inhalation showing LD50 values of > 2000 mg/kg body weight both for the oral and dermal application route and a LC50 of > 22 mg/l for the inhalative route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5835d3df-cbf4-4bda-82fa-399aff6c243f/documents/IUC5-4d3f03eb-209b-4904-8ea7-488434cb3ae5_94f18b9b-5c1b-48bc-be6d-9f40a998a8fe.html,,,,,, Isopropenyl acetate,108-22-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5835d3df-cbf4-4bda-82fa-399aff6c243f/documents/IUC5-4d3f03eb-209b-4904-8ea7-488434cb3ae5_94f18b9b-5c1b-48bc-be6d-9f40a998a8fe.html,,oral,LD50,"2,000 mg/kg bw",, Isopropenyl acetate,108-22-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5835d3df-cbf4-4bda-82fa-399aff6c243f/documents/IUC5-4d3f03eb-209b-4904-8ea7-488434cb3ae5_94f18b9b-5c1b-48bc-be6d-9f40a998a8fe.html,,dermal,LD50,"2,000 mg/kg bw",, Isopropenyl acetate,108-22-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5835d3df-cbf4-4bda-82fa-399aff6c243f/documents/IUC5-4d3f03eb-209b-4904-8ea7-488434cb3ae5_94f18b9b-5c1b-48bc-be6d-9f40a998a8fe.html,,inhalation,LC50,"22,000 mg/m3",, Isopropyl 2-bromo-2-methylpropionate,51368-55-9,Isopropyl 2-bromoisobutyrate has not to be considered as harmful since acute oral or dermal toxicity tests didn't show any mortality rate in rats below a concentration of 2000 mg/kg bodyweight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06f53b6e-c4cd-42b2-9b7f-21f57bbb499e/documents/IUC5-6140b080-3955-4202-bfca-383634a335b9_81598fc5-6044-49d9-be5b-6d311f8778f9.html,,,,,, Isopropyl 2-bromo-2-methylpropionate,51368-55-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06f53b6e-c4cd-42b2-9b7f-21f57bbb499e/documents/IUC5-6140b080-3955-4202-bfca-383634a335b9_81598fc5-6044-49d9-be5b-6d311f8778f9.html,,oral,LD50,"2,000 mg/kg bw",, Isopropyl 2-bromo-2-methylpropionate,51368-55-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06f53b6e-c4cd-42b2-9b7f-21f57bbb499e/documents/IUC5-6140b080-3955-4202-bfca-383634a335b9_81598fc5-6044-49d9-be5b-6d311f8778f9.html,,dermal,LD50,"2,000 mg/kg bw",, Isopropyl 2-methylbutyrate,66576-71-4," A 54 day repeat dose study with a read-across analogue, EMB, showed no signs of toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bcb2777-75a2-4fb8-b51f-1a2983a847c1/documents/IUC5-69e133d9-06e5-4210-9848-2771f0ad249e_29782114-5702-4149-a50b-006c503b97b2.html,,,,,, Isopropyl 2-methylbutyrate,66576-71-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bcb2777-75a2-4fb8-b51f-1a2983a847c1/documents/IUC5-69e133d9-06e5-4210-9848-2771f0ad249e_29782114-5702-4149-a50b-006c503b97b2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Isopropyl 2-methylbutyrate,66576-71-4, On the basis of read across it is not classified for acute inhalation (LC50 5967 mg/m3) or dermal toxicity (LD50 >2000 mg/kg bw). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bcb2777-75a2-4fb8-b51f-1a2983a847c1/documents/IUC5-4bda4af9-2aad-488b-b11c-9c5694182f31_29782114-5702-4149-a50b-006c503b97b2.html,,,,,, Isopropyl 2-methylbutyrate,66576-71-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bcb2777-75a2-4fb8-b51f-1a2983a847c1/documents/IUC5-4bda4af9-2aad-488b-b11c-9c5694182f31_29782114-5702-4149-a50b-006c503b97b2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Isopropyl 2-methylbutyrate,66576-71-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bcb2777-75a2-4fb8-b51f-1a2983a847c1/documents/IUC5-4bda4af9-2aad-488b-b11c-9c5694182f31_29782114-5702-4149-a50b-006c503b97b2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Isopropyl 2-methylbutyrate,66576-71-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bcb2777-75a2-4fb8-b51f-1a2983a847c1/documents/IUC5-4bda4af9-2aad-488b-b11c-9c5694182f31_29782114-5702-4149-a50b-006c503b97b2.html,,inhalation,LC50,"5,967 mg/m3",no adverse effect observed, Isopropyl acetoacetate,542-08-5, The LD50 for acute oral toxicity of the test item in rats was determined to be greater than 2000 mg/kg bw (reference 7.2.1-1). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7a70ab4-0f6a-4db2-9b58-bbce7639e047/documents/6f672b3d-139c-45bb-960d-3e41ba8cc169_56ba5bfa-51a9-4eed-a7f5-bf78164cabba.html,,,,,, Isopropyl acetoacetate,542-08-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7a70ab4-0f6a-4db2-9b58-bbce7639e047/documents/6f672b3d-139c-45bb-960d-3e41ba8cc169_56ba5bfa-51a9-4eed-a7f5-bf78164cabba.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, Isopropylcyclohexane,696-29-7," No repeated-dose toxicity tests are available for the oral and dermal route of exposure. Data waiver are claimed. Under the conditions of the 90 -day inhalation toxicity study in rats, the no observed adverse effect level (NOAEL) for test item is considered to be 1.61 mg/L (CitoxLab, 2017). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef95ce2d-8763-4c10-a54c-2777d4ae556c/documents/IUC5-3e31d2d3-83c0-46e0-96e4-0b4a0605dfc8_0a53facd-7f99-45f0-8a23-76cb972d4365.html,,,,,, Isopropylcyclohexane,696-29-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef95ce2d-8763-4c10-a54c-2777d4ae556c/documents/IUC5-3e31d2d3-83c0-46e0-96e4-0b4a0605dfc8_0a53facd-7f99-45f0-8a23-76cb972d4365.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,610 mg/m3",,rat Isopropylcyclohexane,696-29-7, Acute oral toxcitity study revealed LD50 of greater than 10000 mg/kg bw in rats for isopropylcyclohexane. Furthermore acute inhalation toxicity study was conducted in rats showing an LC50 of greater than 5.04 mg/l for isopropylcyclohexane. Dermal acute toxicity study is not available for this substance. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef95ce2d-8763-4c10-a54c-2777d4ae556c/documents/IUC5-8e8f68f8-59ae-4156-88bc-b5007471f95f_0a53facd-7f99-45f0-8a23-76cb972d4365.html,,,,,, Isopropylcyclohexane,696-29-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef95ce2d-8763-4c10-a54c-2777d4ae556c/documents/IUC5-8e8f68f8-59ae-4156-88bc-b5007471f95f_0a53facd-7f99-45f0-8a23-76cb972d4365.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Isopropylcyclohexane,696-29-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef95ce2d-8763-4c10-a54c-2777d4ae556c/documents/IUC5-8e8f68f8-59ae-4156-88bc-b5007471f95f_0a53facd-7f99-45f0-8a23-76cb972d4365.html,,inhalation,LC50,"5,040 mg/m3",no adverse effect observed, Isopropylnaphthalene,29253-36-9,"Two valid repeated-dose toxicity studies have been located, one for the target substance isopropylnaphthalene (28 d) and one for the supporting substance bis(isopropylnaphthalene (6 month). The more conservative NOAEL for bis(isopropyl)naphthalene has been selected for further use in the chemical safety assessment. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e823915-61c3-470e-962b-1b35de654c1e/documents/IUC5-37224b08-64ac-494a-b776-60bcead8004e_d6b749e7-21c3-414b-b439-e3dfd0569dab.html,,,,,, Isopropylnaphthalene,29253-36-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e823915-61c3-470e-962b-1b35de654c1e/documents/IUC5-37224b08-64ac-494a-b776-60bcead8004e_d6b749e7-21c3-414b-b439-e3dfd0569dab.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,170 mg/kg bw/day,,rat Isopropylnaphthalene,29253-36-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): acceptable for assessment, SAR Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): acceptable for assessment, SAR Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): acceptable for assessment, SAR ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e823915-61c3-470e-962b-1b35de654c1e/documents/IUC5-2aa0cdee-8f95-4e3b-8398-b1424d8bf4f9_d6b749e7-21c3-414b-b439-e3dfd0569dab.html,,,,,, Isopropylnaphthalene,29253-36-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e823915-61c3-470e-962b-1b35de654c1e/documents/IUC5-2aa0cdee-8f95-4e3b-8398-b1424d8bf4f9_d6b749e7-21c3-414b-b439-e3dfd0569dab.html,,oral,LD50,"4,130 mg/kg bw",no adverse effect observed, Isopropylnaphthalene,29253-36-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e823915-61c3-470e-962b-1b35de654c1e/documents/IUC5-2aa0cdee-8f95-4e3b-8398-b1424d8bf4f9_d6b749e7-21c3-414b-b439-e3dfd0569dab.html,,dermal,LD50,"4,500 mg/kg bw",no adverse effect observed, Isopropylnaphthalene,29253-36-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e823915-61c3-470e-962b-1b35de654c1e/documents/IUC5-2aa0cdee-8f95-4e3b-8398-b1424d8bf4f9_d6b749e7-21c3-414b-b439-e3dfd0569dab.html,,inhalation,LC50,"5,640 mg/m3",no adverse effect observed, "Juniper, Juniperus mexicana, ext., isomerized, acetylated",91053-33-7," Oral: LD50 > 2000 mg/kg bw and the LD50= LD50 cut-off was considered to be > 5000mg/kg bw female rat, OECD TG 423, 2015 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef7219ed-899b-44db-9cee-88cb138aa5c3/documents/df54078c-521b-4721-85ba-65aeb4dba919_6f8bdd70-3e1d-4808-bedb-05a138683386.html,,,,,, "Juniper, Juniperus mexicana, ext., isomerized, acetylated",91053-33-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef7219ed-899b-44db-9cee-88cb138aa5c3/documents/df54078c-521b-4721-85ba-65aeb4dba919_6f8bdd70-3e1d-4808-bedb-05a138683386.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Kaolin, calcined",92704-41-1,Oral: NOAEL (male rats): 1760 - 3000 mg/kg bw/day (RA Syloid 244; 103 weeks)NOAEL (female rats): 1780 - 3210 mg/kg bw/day (RA Syloid 244; 103 weeks)Dermal:No dermal repeated dose toxicity studies.Inhalation: NOAEC (rats): 1.3 mg/m³ (RA Aerosil 200; 13 weeks) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/deabd386-8d1a-4097-9a86-9138f8c61fd5/documents/IUC5-bfeaefcb-a7f8-4d82-985f-313eb5d6a437_840d00a4-2463-4b42-9619-de6d5b688acc.html,,,,,, "Kaolin, calcined",92704-41-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/deabd386-8d1a-4097-9a86-9138f8c61fd5/documents/IUC5-bfeaefcb-a7f8-4d82-985f-313eb5d6a437_840d00a4-2463-4b42-9619-de6d5b688acc.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,1.3 mg/m3,,rat "Kaolin, calcined",92704-41-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/deabd386-8d1a-4097-9a86-9138f8c61fd5/documents/IUC5-bfeaefcb-a7f8-4d82-985f-313eb5d6a437_840d00a4-2463-4b42-9619-de6d5b688acc.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,760 mg/kg bw/day",,rat "Kaolin, calcined",92704-41-1,"Oral: LD50 (rats) > 5000 mg/kg bw (RA Kaolin clay; limit test)Inhalation:LC50 (rats) > 2.07 mg/L air (4 hours, limit test)Dermal:LD50 (rats) > 5000 mg/kg bw (RA Kaolin clay; 24 hours, limit test) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/deabd386-8d1a-4097-9a86-9138f8c61fd5/documents/IUC5-2e1c3139-de84-45ba-bd13-f25abb5eb241_840d00a4-2463-4b42-9619-de6d5b688acc.html,,,,,, "Kerosine (petroleum), hydrodesulfurized",64742-81-0,"A number of subacute and subchronic studies with kerosines and jet fuels are available (OECD 410, 412, 413, and other non-guideline protocols). The repeated inhalation and oral studies of kerosine in rats produced no consistent toxicological effects other than changes in male rat kidneys that are not considered relevant to humans. The NOAEC for inhalation exposure is greater than or equal to 1000 mg/m3 (vapour).  The systemic dermal NOAEL is greater than or equal to 495 mg/kg bw/day, based on a well conducted 90-day study in rats.  The NOAEL for systemic effects of oral exposure is 750 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/541b5c11-838d-4882-9082-d4f940735514/documents/89277e09-fd6a-4778-85aa-41521a1ff043_ab6ae6d1-0ad5-4f41-a865-a0e85107ea17.html,,,,,, "Kerosine (petroleum), hydrodesulfurized",64742-81-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/541b5c11-838d-4882-9082-d4f940735514/documents/89277e09-fd6a-4778-85aa-41521a1ff043_ab6ae6d1-0ad5-4f41-a865-a0e85107ea17.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Kerosine (petroleum), hydrodesulfurized",64742-81-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/541b5c11-838d-4882-9082-d4f940735514/documents/89277e09-fd6a-4778-85aa-41521a1ff043_ab6ae6d1-0ad5-4f41-a865-a0e85107ea17.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,495 mg/kg bw/day,,rat "Kerosine (petroleum), hydrodesulfurized",64742-81-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/541b5c11-838d-4882-9082-d4f940735514/documents/89277e09-fd6a-4778-85aa-41521a1ff043_ab6ae6d1-0ad5-4f41-a865-a0e85107ea17.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat "Kerosine (petroleum), hydrodesulfurized",64742-81-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/541b5c11-838d-4882-9082-d4f940735514/documents/89277e09-fd6a-4778-85aa-41521a1ff043_ab6ae6d1-0ad5-4f41-a865-a0e85107ea17.html,Repeated dose toxicity – local effects,dermal,LOAEL,1 mg/cm2,adverse effect observed,rat "Kerosine (petroleum), hydrodesulfurized",64742-81-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/541b5c11-838d-4882-9082-d4f940735514/documents/89277e09-fd6a-4778-85aa-41521a1ff043_ab6ae6d1-0ad5-4f41-a865-a0e85107ea17.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,000 mg/m3",no adverse effect observed,rat "Kerosine (petroleum), hydrodesulfurized",64742-81-0,"Kerosines are of low acute toxicity with mortality rarely reported even at very high exposures in experimental animal studies conducted by oral (similar to OECD 420), dermal (similar to OECD 402), and inhalation (similar to OECD 403) exposure.  • The oral LD50 was > 5000 mg/kg bw in male and female rats for kerosine.• The dermal LD50 was > 2000 mg/kg/bw in male and female rabbits for kerosine.• The inhalation LC50 was > 5.28 mg/L vapour in male and female rats for kerosine. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/541b5c11-838d-4882-9082-d4f940735514/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_ab6ae6d1-0ad5-4f41-a865-a0e85107ea17.html,,,,,, "Kerosine (petroleum), hydrodesulfurized",64742-81-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/541b5c11-838d-4882-9082-d4f940735514/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_ab6ae6d1-0ad5-4f41-a865-a0e85107ea17.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Kerosine (petroleum), hydrodesulfurized",64742-81-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/541b5c11-838d-4882-9082-d4f940735514/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_ab6ae6d1-0ad5-4f41-a865-a0e85107ea17.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Kerosine (petroleum), hydrodesulfurized",64742-81-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/541b5c11-838d-4882-9082-d4f940735514/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_ab6ae6d1-0ad5-4f41-a865-a0e85107ea17.html,,inhalation,LC50,"5,280 mg/m3",no adverse effect observed, "Kerosine (petroleum), straight-run wide-cut",92045-37-9,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd9c99ba-358b-4c1c-bafa-721da8dcedcc/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_6839bf44-cef4-4f7c-b672-fcb539db1761.html,,,,,, "Kerosine (petroleum), straight-run wide-cut",92045-37-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd9c99ba-358b-4c1c-bafa-721da8dcedcc/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_6839bf44-cef4-4f7c-b672-fcb539db1761.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Kerosine (petroleum), straight-run wide-cut",92045-37-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd9c99ba-358b-4c1c-bafa-721da8dcedcc/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_6839bf44-cef4-4f7c-b672-fcb539db1761.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Kerosine (petroleum), straight-run wide-cut",92045-37-9," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd9c99ba-358b-4c1c-bafa-721da8dcedcc/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_6839bf44-cef4-4f7c-b672-fcb539db1761.html,,,,,, "Kerosine (petroleum), straight-run wide-cut",92045-37-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd9c99ba-358b-4c1c-bafa-721da8dcedcc/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_6839bf44-cef4-4f7c-b672-fcb539db1761.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Kerosine (petroleum), straight-run wide-cut",92045-37-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd9c99ba-358b-4c1c-bafa-721da8dcedcc/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_6839bf44-cef4-4f7c-b672-fcb539db1761.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Kerosine (petroleum), straight-run wide-cut",92045-37-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd9c99ba-358b-4c1c-bafa-721da8dcedcc/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_6839bf44-cef4-4f7c-b672-fcb539db1761.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Kerosine (petroleum), sweetened",91770-15-9,"A number of subacute and subchronic studies with kerosines and jet fuels are available (OECD 410, 412, 413, and other non-guideline protocols). The repeated inhalation and oral studies of kerosine in rats produced no consistent toxicological effects other than changes in male rat kidneys that are not considered relevant to humans. The NOAEC for inhalation exposure is greater than or equal to 1000 mg/m3 (vapour).  The systemic dermal NOAEL is greater than or equal to 495 mg/kg bw/day, based on a well conducted 90-day study in rats.  The NOAEL for systemic effects of oral exposure is 750 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a10faa52-105a-4509-b3a2-954bbe9e63f2/documents/89277e09-fd6a-4778-85aa-41521a1ff043_bbffade5-79c0-4159-bf6f-c643a78f759e.html,,,,,, "Kerosine (petroleum), sweetened",91770-15-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a10faa52-105a-4509-b3a2-954bbe9e63f2/documents/89277e09-fd6a-4778-85aa-41521a1ff043_bbffade5-79c0-4159-bf6f-c643a78f759e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Kerosine (petroleum), sweetened",91770-15-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a10faa52-105a-4509-b3a2-954bbe9e63f2/documents/89277e09-fd6a-4778-85aa-41521a1ff043_bbffade5-79c0-4159-bf6f-c643a78f759e.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,495 mg/kg bw/day,,rat "Kerosine (petroleum), sweetened",91770-15-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a10faa52-105a-4509-b3a2-954bbe9e63f2/documents/89277e09-fd6a-4778-85aa-41521a1ff043_bbffade5-79c0-4159-bf6f-c643a78f759e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat "Kerosine (petroleum), sweetened",91770-15-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a10faa52-105a-4509-b3a2-954bbe9e63f2/documents/89277e09-fd6a-4778-85aa-41521a1ff043_bbffade5-79c0-4159-bf6f-c643a78f759e.html,Repeated dose toxicity – local effects,dermal,LOAEL,1 mg/cm2,adverse effect observed,rat "Kerosine (petroleum), sweetened",91770-15-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a10faa52-105a-4509-b3a2-954bbe9e63f2/documents/89277e09-fd6a-4778-85aa-41521a1ff043_bbffade5-79c0-4159-bf6f-c643a78f759e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,000 mg/m3",no adverse effect observed,rat "Kerosine (petroleum), sweetened",91770-15-9,"Kerosines are of low acute toxicity with mortality rarely reported even at very high exposures in experimental animal studies conducted by oral (similar to OECD 420), dermal (similar to OECD 402), and inhalation (similar to OECD 403) exposure.  • The oral LD50 was > 5000 mg/kg bw in male and female rats for kerosine.• The dermal LD50 was > 2000 mg/kg/bw in male and female rabbits for kerosine.• The inhalation LC50 was > 5.28 mg/L vapour in male and female rats for kerosine. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a10faa52-105a-4509-b3a2-954bbe9e63f2/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_bbffade5-79c0-4159-bf6f-c643a78f759e.html,,,,,, "Kerosine (petroleum), sweetened",91770-15-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a10faa52-105a-4509-b3a2-954bbe9e63f2/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_bbffade5-79c0-4159-bf6f-c643a78f759e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Kerosine (petroleum), sweetened",91770-15-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a10faa52-105a-4509-b3a2-954bbe9e63f2/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_bbffade5-79c0-4159-bf6f-c643a78f759e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Kerosine (petroleum), sweetened",91770-15-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a10faa52-105a-4509-b3a2-954bbe9e63f2/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_bbffade5-79c0-4159-bf6f-c643a78f759e.html,,inhalation,LC50,"5,280 mg/m3",no adverse effect observed, "Kieselguhr, soda ash flux-calcined",68855-54-9,"A 90 day oral study in rats, NOAEL 3737.9 mg/kg (highest concentration tested) no treatment related effects. No dermal repeat dose studies have been considered neccssary. Repeat dose inhalation studies performed using either the substance itself or amoprhous or crystalline silica demonstrate that, although amorphous silica does cause a transient inflammatory response, crystalline silica at lower time- or dose-exposure leads to much more persistent (and consequently much more severe) pulmonary toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd5cf9a5-800d-435d-bac6-dbfe069fb639/documents/IUC5-58cb6792-712a-4908-9754-ad7ffe44e0ba_f9a71612-5625-4999-bb23-b724374b33e3.html,,,,,, "Kieselguhr, soda ash flux-calcined",68855-54-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd5cf9a5-800d-435d-bac6-dbfe069fb639/documents/IUC5-58cb6792-712a-4908-9754-ad7ffe44e0ba_f9a71612-5625-4999-bb23-b724374b33e3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,737.9 mg/kg bw/day",,rat "Kieselguhr, soda ash flux-calcined",68855-54-9,The acute toxicity of kieselguhr soda ash flux calcined was tested via the oral and dermal route. The dermal toxicity was not considered relevant. Acute oral toxicity study in rats (OECD TG 420) LD50 >2000 mg/kg. Acute inhalation toxicity study in rats (OECD TG 403) LD50 >2.6 mg/L maximum attainable dose concentration. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd5cf9a5-800d-435d-bac6-dbfe069fb639/documents/IUC5-cb9af532-90d3-4456-be10-9a42f7ac160e_f9a71612-5625-4999-bb23-b724374b33e3.html,,,,,, L-(+)-lactic acid,79-33-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Guideline study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Guideline study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Guideline study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd063349-edce-4168-b81a-00a9154030ad/documents/758c31cc-e595-413e-af97-c3dde5c2ec91_2e706460-cedc-4d0a-9677-326bf59e6f17.html,,,,,, L-(+)-lactic acid,79-33-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd063349-edce-4168-b81a-00a9154030ad/documents/758c31cc-e595-413e-af97-c3dde5c2ec91_2e706460-cedc-4d0a-9677-326bf59e6f17.html,,oral,LD50,"3,543 mg/kg bw",adverse effect observed, L-(+)-lactic acid,79-33-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd063349-edce-4168-b81a-00a9154030ad/documents/758c31cc-e595-413e-af97-c3dde5c2ec91_2e706460-cedc-4d0a-9677-326bf59e6f17.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, L-(+)-lactic acid,79-33-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd063349-edce-4168-b81a-00a9154030ad/documents/758c31cc-e595-413e-af97-c3dde5c2ec91_2e706460-cedc-4d0a-9677-326bf59e6f17.html,,inhalation,LC50,> 7.94 mg/L,adverse effect observed, L-2-hydroxy-2-phenylacetic acid,611-71-2,"LD50 (oral,rat): ca. 5000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c499af9-6138-4ee0-bc56-fb5fc93394ee/documents/IUC5-3355d1a1-2b11-4593-ae68-134123002d86_4f1b74d8-fffa-4a37-a8c3-26a6bcd87e07.html,,,,,, L-2-hydroxy-2-phenylacetic acid,611-71-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c499af9-6138-4ee0-bc56-fb5fc93394ee/documents/IUC5-3355d1a1-2b11-4593-ae68-134123002d86_4f1b74d8-fffa-4a37-a8c3-26a6bcd87e07.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, (1-ethoxy-1-oxopropan-2-yl) 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate,77501-63-4,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/754c524c-aedc-4173-98d6-38cbaf1469f5/documents/IUC5-19fdd993-79af-40c6-a23a-26ce68f42fad_bd91a01d-7cde-48ef-a8e6-71b9128cccd8.html,Chronic toxicity – systemic effects,oral,NOAEL,0.79 mg/kg bw/day,,dog (1-ethoxy-1-oxopropan-2-yl) 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate,77501-63-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): 2 Studies are available. Overall, the cut-off LD50 of 500 mg/kg will be used for risk assessment although this value might be to conservative, based on the atrificial formulation of the test item in this study. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): LC50 was > 5.30 mg/l, highest attainable aerosol concentration. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Effects observed at 2000 mg/kg but not deaths reported; LD0 >/= 2000 mg/kg ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/754c524c-aedc-4173-98d6-38cbaf1469f5/documents/IUC5-9e5ab34e-7609-4658-83eb-06b3b361c19f_bd91a01d-7cde-48ef-a8e6-71b9128cccd8.html,,,,,, (1-ethoxy-1-oxopropan-2-yl) 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate,77501-63-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/754c524c-aedc-4173-98d6-38cbaf1469f5/documents/IUC5-9e5ab34e-7609-4658-83eb-06b3b361c19f_bd91a01d-7cde-48ef-a8e6-71b9128cccd8.html,,oral,LD50,500 mg/kg bw,adverse effect observed, (1-ethoxy-1-oxopropan-2-yl) 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate,77501-63-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/754c524c-aedc-4173-98d6-38cbaf1469f5/documents/IUC5-9e5ab34e-7609-4658-83eb-06b3b361c19f_bd91a01d-7cde-48ef-a8e6-71b9128cccd8.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, (1-ethoxy-1-oxopropan-2-yl) 5-[2-chloro-4-(trifluoromethyl)phenoxy]-2-nitrobenzoate,77501-63-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/754c524c-aedc-4173-98d6-38cbaf1469f5/documents/IUC5-9e5ab34e-7609-4658-83eb-06b3b361c19f_bd91a01d-7cde-48ef-a8e6-71b9128cccd8.html,,inhalation,LC50,"5,300 mg/m3",no adverse effect observed, Lanthanum,7439-91-0,"No studies are available on the registration substance since it is technically not possible to dose the registration substance in repeated dose toxicity tests since it reacts with water to produce flammable gases. To address any potential adverse effects which may occur as a result of exposure to the metal ion, a read across study, on an inorganic compound was included. No adverse effects relating to treatment were observed during the 90 day (oral) study and so the NOAEL was determined to be is 741 mg/kg bw/d for males and 1126 mg/kg bw/d females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24726da7-cd0c-4313-a347-88ddffdf1ce6/documents/IUC5-7af8e531-36c7-46ea-b3a1-e1c0ba4e3139_f2afb8d0-b560-4286-ad4f-711ccd1f530b.html,,,,,, Lanthanum fluoride,13709-38-1,"Oral (28-day): Male/female NOAEL 1000 mg/kg bw, female; OECD 422, Charles River (2013) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a952124-198d-4321-b8ee-e660cce6cd93/documents/IUC5-1fc992f4-c89b-4d24-8812-5f550564996f_7c3ca6fd-f114-4c7d-9886-2b600f49050f.html,,,,,, Lanthanum fluoride,13709-38-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a952124-198d-4321-b8ee-e660cce6cd93/documents/IUC5-1fc992f4-c89b-4d24-8812-5f550564996f_7c3ca6fd-f114-4c7d-9886-2b600f49050f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Lanthanum fluoride,13709-38-1,ACUTE TOXICITY: ORALThe LD50 of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.ACUTE TOXICITY: INHALATIONThe LC50 of the test material in the Wistar strain rat was found to be greater than 5.10 mg/L.ACUTE TOXICITY: DERMALThis study was waived on the basis that the oral and inhalation routes of adminstration were considered more relevant when considering the physical nature and use pattern of the substance. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a952124-198d-4321-b8ee-e660cce6cd93/documents/IUC5-2fdbcfe7-fe4a-4d1a-a916-cab33bae9e66_7c3ca6fd-f114-4c7d-9886-2b600f49050f.html,,,,,, Lanthanum oxide,1312-81-8,In a 90-day dietary study with lanthanum carbonate in rats no treatment related adverse effects were obseved up to the highest dose tested (14000 ppm or 974 mg/kg bw/d for males and 1480 mg/kg bw/day for females) corresponding to a NOAEL > 525 mg/kg bw/d for males and > 799 mg/kg bw/day for females based on Lanthanum oxide. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8599e177-db55-4b3e-9592-f356d95b71e8/documents/IUC5-ffb745cf-a3ca-4136-903d-33a5821bea35_b769e9c7-291e-48df-b24f-660698ceba91.html,,,,,, Lanthanum oxide,1312-81-8,Lanthanum oxide was of low acute toxicity to rats via the oral and inhalation routes of exposure. No mortality and signs of toxicity were observed at the limit doses of 5000 and 10000 mg/kg bw via the oral route and 5.3 mg/L via the inhalation route of exposure. The analoguous substance lanthanum chloride was also tested via the dermal exposure route in rabbits and did not reveal any signs of toxicity at the limit dose of 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8599e177-db55-4b3e-9592-f356d95b71e8/documents/IUC5-911500ec-978c-4566-ab5d-bab7c2a2a374_b769e9c7-291e-48df-b24f-660698ceba91.html,,,,,, Lanthanum oxide,1312-81-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8599e177-db55-4b3e-9592-f356d95b71e8/documents/IUC5-911500ec-978c-4566-ab5d-bab7c2a2a374_b769e9c7-291e-48df-b24f-660698ceba91.html,,oral,discriminating dose,"10,000 mg/kg bw",, Lanthanum oxide,1312-81-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8599e177-db55-4b3e-9592-f356d95b71e8/documents/IUC5-911500ec-978c-4566-ab5d-bab7c2a2a374_b769e9c7-291e-48df-b24f-660698ceba91.html,,dermal,discriminating dose,"2,000 mg/kg bw",, Lanthanum oxide,1312-81-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8599e177-db55-4b3e-9592-f356d95b71e8/documents/IUC5-911500ec-978c-4566-ab5d-bab7c2a2a374_b769e9c7-291e-48df-b24f-660698ceba91.html,,inhalation,discriminating conc.,"5,300 mg/m3",, Lanthanum trihydroxide,14507-19-8," Although no repeated dose toxicity study data is available for the registered substance, a sub-chronic repeated dose toxicity study is available on the read across substance, lanthanum tricarbonate. No adverse effects relating to treatment were observed during the 90 day (oral) study and so the NOAEL was determined to be 741 mg/kg bw/d for males and 1126 mg/kg bw/d females (actual dose ingested, based on anhydrous lanthanum tricarbonate).. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c371074-dee0-43d4-b0d2-8da2c579b240/documents/IUC5-c067d184-9f6e-4555-a494-9391b230c69b_1bd6a662-a984-4ccd-9b39-44495407602b.html,,,,,, Lanthanum trihydroxide,14507-19-8, ACUTE TOXICITY: ORAL The LD50 of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight. ACUTE TOXICITY: DERMAL The LD50 of the test material in male and female Wistar strain rats was found to be greater than 2000 mg/kg bodyweight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c371074-dee0-43d4-b0d2-8da2c579b240/documents/IUC5-116e3d23-bf01-4c34-b28f-c29a79ff1300_1bd6a662-a984-4ccd-9b39-44495407602b.html,,,,,, Lanthanum trinitrate,10099-59-9,Repeated dose toxicity: oralBraun (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test in rats with the read-across substance lanthanum acetate according to OECD Guideline 422 (GLP). A NOAEL for systemic toxicity of >= 1000 mg/kg bw/day was derived. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d6e3497f-2524-48ae-b5b0-1d9c1a7927ee/documents/643bf677-5a02-4c56-83a6-1bd80b5ff8ee_be583acc-b6f1-460d-9e52-28828d6ccaf5.html,,,,,, Lanthanum trinitrate,10099-59-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d6e3497f-2524-48ae-b5b0-1d9c1a7927ee/documents/643bf677-5a02-4c56-83a6-1bd80b5ff8ee_be583acc-b6f1-460d-9e52-28828d6ccaf5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Lanthanum trinitrate,10099-59-9,"Acute toxicity: oralA K2 acute oral toxicity test was performed in male and female Sprague-Dawley rats according to a guideline similar to OECD Guideline 401 (Cochran et al., 1950 and Lewis, 1995). The LD50 was calculated to be 4500 mg compound/kg bw. This study was selected as key study.Acute toxicity: inhalationNo data are available for inhalatory exposure. Acute toxicity: dermalBradshaw (2013a) performed an acute dermal toxicity study (limit test) in Wistar rats similar to the OECD 402 test guideline and EU Method B.3, using a semi-occlusive cover. The test item was the read-across substance lanthanum acetate, another soluble lanthanum compound. An unbounded LD50 value above 2000 mg/kg bw was derived for male and female rats. The read-across justification is added in Section 13 of IUCLID. A maximal reliability score of 2 (reliable with restrictions) is assigned because the study has been used for read-across purposes in this dossier. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6e3497f-2524-48ae-b5b0-1d9c1a7927ee/documents/3a2beb08-aef7-4cac-a5dc-ba9db999ee0a_be583acc-b6f1-460d-9e52-28828d6ccaf5.html,,,,,, Lanthanum trinitrate,10099-59-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6e3497f-2524-48ae-b5b0-1d9c1a7927ee/documents/3a2beb08-aef7-4cac-a5dc-ba9db999ee0a_be583acc-b6f1-460d-9e52-28828d6ccaf5.html,,oral,LD50,"4,500 mg/kg bw",no adverse effect observed, Lanthanum(3+) acetate,917-70-4,Repeated dose toxicity: oralBraun (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test in rats according to OECD guideline 422 (GLP). A NOAEL for systemic toxicity of >= 1000 mg lanthanum acetate (anhydrous)/kg bw/day was derived (the highest dose tested; limit dose in this type of study). The study was scored Klimisch K1 and it is considered as key study. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6fcda8d-abd0-47d5-b3b6-56de8b7483dd/documents/IUC5-71d7b307-905f-4cf4-bd0e-66f8408f927b_a8d50a38-35a6-4ec5-af8e-b8455e2f1470.html,,,,,, Lanthanum(3+) acetate,917-70-4,"Acute toxicity: oralA K2 acute oral toxicity test was performed in male and female Sprague Dawley rats according to a guideline similar to OECD Guideline 401 (Cochran, 1950). This study was selected as key study, as the other available information came from a secondary source (considered K4) Acute toxicity: inhalation:no study available for this endpointAcute toxicity: dermal: A K1 acute dermal toxicity test was performed in male and female Wistar rats following the OECD 402 Guideline (Bradshaw, 2013). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6fcda8d-abd0-47d5-b3b6-56de8b7483dd/documents/IUC5-257f5be9-08ff-4241-86e7-17ffa31bd5f7_a8d50a38-35a6-4ec5-af8e-b8455e2f1470.html,,,,,, Lanthanum(3+) acetate,917-70-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6fcda8d-abd0-47d5-b3b6-56de8b7483dd/documents/IUC5-257f5be9-08ff-4241-86e7-17ffa31bd5f7_a8d50a38-35a6-4ec5-af8e-b8455e2f1470.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Lanthanum(3+) acetate,917-70-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6fcda8d-abd0-47d5-b3b6-56de8b7483dd/documents/IUC5-257f5be9-08ff-4241-86e7-17ffa31bd5f7_a8d50a38-35a6-4ec5-af8e-b8455e2f1470.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, L-arabinose,5328-37-0," An Intake Assessment was performed to estimate the average daily intake of L-Arabinose (L-ARA) with a habitual diet. Three main foodstuffs were considered, complemented by the intake of L-Arabinose by gum arabic as food additive. A rough estimate of the dietary L-Arabinose consumption could be calculated. The highest contributor to the L-Arabinose intake in humans is gum arabic, which is widely used as food additive. The range of L-Arabinose intake by consumption of gum arabic as food additive variesfrom 0.61 to 25.1 g for adolescents and 0.37 g to 19.8 g for adults. Natural plant based foodstuffs contain L-ARA as a part of the NSP fraction, which at least to some extend are broken down to monomeric L-ARA in the GI-tract. Through the intake data of three main foodstuffs: apples, pears and beans, they provide evidence of a substantial L-ARA consumption with the habitual diet. Dried beans may contribute substantially to the L-arabinose intake. With this high daily intake of L-ARA in polysaccharide bound form and partial hydrolysis in the GI tract in human, thereof it can be concluded that safety of L-ARA is substantiated. As there is no evidence of any adverse effect of this ubiquitous pentose, which is part of the human food chain, no further animal safety testing is necessary for REACH registration of L-ARA. According to REGULATION (EC) No 1907/2006, Annex VIII/IX, testing for repeated dose toxicity (section 8.6) may be omitted, if testing does not appear scientifically necessary. According to Annex XI section 1.1.2, adequate data on human health properties should be considered to be equivalent to data generated by the corresponding test methods referred to in Article 13 (3) if the following conditions are met: 1) adequacy for the purpose of classification and labelling and/or risk assessment; 2) adequate and reliable coverage of the key parameters foreseen to be investigated in the corresponding test methods referred to in Article 13(3); 3) exposure duration comparable to or longer than the corresponding test methods referred to in Article 13(3); and 4) adequate and reliable documentation is provided. In addition and in accordance with Annex XI section 1.2, relevant independent sources of information are available, leading to the conclusion that the substance has not a particular dangerous property. Therefore, further testing on vertebrate animals for that property shall be omitted where adequate and reliable data for the absence of a particular dangerous property is available. Based on adequate data from the Intake Assessment, a history of safe use of L-Arabinose in humans can be concluded. There is no evidence of any adverse effect of this ubiquitous pentose, which is part of the human food chain. In the light of this habitual exposure to L-Arabinose, the safety of orally ingested L-Arabinose is evident and additional animal trials to study repeated dose toxicity including reproductive and developmental toxicity is unjustified. Also from an animal welfare perspective, unnecessary animal trials should be avoided when there is no indication for toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29d67a5f-6caa-4fe7-a456-a73e2203d7b4/documents/2d158aa0-fdeb-46d6-9bf9-d2932398fd72_9ca386c9-e956-4f6e-a18e-51808036956f.html,,,,,, L-arabinose,5328-37-0," In an acute oral toxicity study in rats according to OECD Guideline 423, the determined LD50 was above 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29d67a5f-6caa-4fe7-a456-a73e2203d7b4/documents/5516b05b-7a04-46de-9069-6292e710ae96_9ca386c9-e956-4f6e-a18e-51808036956f.html,,,,,, L-arabinose,5328-37-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29d67a5f-6caa-4fe7-a456-a73e2203d7b4/documents/5516b05b-7a04-46de-9069-6292e710ae96_9ca386c9-e956-4f6e-a18e-51808036956f.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, L-arginine phosphate,49720-39-0,"No treatment- related effects were observed in rats in a 13-week oral toxicity study of L-Arginine with a 5-week recovery study was conducted. No dose-related deaths were observed throughout the administration and recovery periods. Furthermore, no dose-related changes were observed in the clinical signs, body weight, food consumption, food efficiency, ophthalmological examination, hematological examination, blood chemical examination, necropsy and histopathological examination. Therefore, the no-observed-adverse-effect level (NOAEL) was set at a dietary dose of 5.0 % L-arginine (equivalent to an overall mean intake of 3130.9 (males) and 3565.1 (females) mg/kg body weight/day). A sub-chronic oral toxicity guideline study of L-arginine with rats was conducted for 90 days. The feeding of L-arginine was not associated with overt signs of toxicity. The NOAEL was estimated to be 5.0% for males (3.3 ± 0.1 g/kg/day) and 5.0% for females (3.9 ± 0.2 g/kg/day). Based on structural similarity and  analogue approach, no repeated dose toxicity is assumed for the target substance L-arginine phosphate. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/243401f2-1746-40d9-b434-19c0540f4018/documents/d47ed1ec-a1fb-4b1a-906d-7b0414bbd18f_296176c2-4623-44cc-8dbc-55482444f760.html,,,,,, "L-Arginine, N2-(2,3-dihydroxypropyl)-, monohydrochloride",709647-81-4,"Acute Toxicity Oral (Breglia et al 1973) (read-across): LD50 of 2,880 mg/kg bw/day Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Pre-Guideline study, well conducted, K2 as some of the expected parameters outlined in the OECD Guideline parameters were not included. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42efdd02-b4dc-4493-9c30-1705cb688bcd/documents/35d12085-7cb7-4280-af39-104aebe49dc7_a0005f12-774b-4406-b2eb-dc1ed1486013.html,,,,,, "L-Arginine, N2-(2,3-dihydroxypropyl)-, monohydrochloride",709647-81-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42efdd02-b4dc-4493-9c30-1705cb688bcd/documents/35d12085-7cb7-4280-af39-104aebe49dc7_a0005f12-774b-4406-b2eb-dc1ed1486013.html,,oral,LD50,"2,880 mg/kg bw",no adverse effect observed, L-born-2-yl acetate,5655-61-8,"Key study: Test method similar to OECD 408. No data on GLP. Based on the read-across approach, the NOEL for laevo bornyl acetate after an oral exposure of 13 weeks was determined to be 15 mg/kg bw/day in rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d000826-4c8c-4303-9398-9eac3738b615/documents/IUC5-5bf2de76-2ae5-4f14-8cb1-82726e79e1ef_99d2692a-ecc4-4c2a-88f8-171af8f3af43.html,,,,,, L-born-2-yl acetate,5655-61-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d000826-4c8c-4303-9398-9eac3738b615/documents/IUC5-5bf2de76-2ae5-4f14-8cb1-82726e79e1ef_99d2692a-ecc4-4c2a-88f8-171af8f3af43.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat L-born-2-yl acetate,5655-61-8,"Acute toxicity, oral: Key study: The LD50 of laevo bornyl acetate in rats is greater than 5000 mg/kg bw. Supporting study: Based on the read-across approach, the oral LD50 was > 10000 mg/kg bw in rats and 9000 mg/kg bw in mice.Acute toxicity, dermal: Key study: The dermal LD50 in rabbit is greater than 10 mL/kg bw (~10000 mg/kg bw). Supporting study: Based on the read-across approach, the dermal LD50 of laevo bornyl acetate was > 20000 mg/kg bw/day in rabbits. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d000826-4c8c-4303-9398-9eac3738b615/documents/IUC5-57cd7ed9-6f36-4342-9031-1aa5f660a3a5_99d2692a-ecc4-4c2a-88f8-171af8f3af43.html,,,,,, L-born-2-yl acetate,5655-61-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d000826-4c8c-4303-9398-9eac3738b615/documents/IUC5-57cd7ed9-6f36-4342-9031-1aa5f660a3a5_99d2692a-ecc4-4c2a-88f8-171af8f3af43.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, L-born-2-yl acetate,5655-61-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d000826-4c8c-4303-9398-9eac3738b615/documents/IUC5-57cd7ed9-6f36-4342-9031-1aa5f660a3a5_99d2692a-ecc4-4c2a-88f8-171af8f3af43.html,,dermal,LD50,"10,000 mg/kg bw",no adverse effect observed, "Reaction mass of 2,4-dimethylphenol and 2,5-dimethylphenol",1638758-52-7,"Repeat Dose Oral Toxicity: Key study: mixed xylenols (28 days combined reproductive / toxicity study). York, 2005. KL.1. NOAEL 100 mg/kg; Supporting study: mixed ethylphenols (28 days combined reproductive / toxicity study). York, 2005. KL.1. NOAEL 100 mg/kg; Supporting study: m-cresol (28 day). MHWL, 2001. KL.1. NOAEL males: 300 mg/kg/day; females: 100 mg/kg/day; Supporting study: p-cresol (28 day). IBTL, 1969. KL.3. NOAEL 45.2 mg/kg/day; Weight of evidence: m-cresol (90 day, oral). RTI, 1988. KL.1. NOAEL: 50 mg/kg/day; Weight of evidence: o-cresol (90 day, oral). RTI, 1988. KL.1. NOAEL: 50 mg/kg/day; Weight of evidence: o-cresol (90 day, diet, rat). RTI, 1988. KL.1. NOAEL males: 247 mg/kg/day; females: 256 mg/kg/day; Weight of evidence: o-cresol (90 day, diet, mouse). RTI, 1988. KL.1. NOAEL males: 199 mg/kg/day; females: 237 mg/kg/day; Weight of evidence: p-cresol (90 day, oral). RTI, 1988. KL.1. NOAEL 50 mg/kg/day; Repeat Dose Dermal Toxicity: No key or supporting studies identifed; Repeat Dose Inhalation Toxicity: No key or supporting studies identifed; ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0bbf540-0ae1-4637-b2f7-22da3de424ed/documents/IUC5-514b784d-5b0e-4dcc-8a13-10be527f6953_15632efe-6c48-4146-b493-62a4d025a4c4.html,,,,,, "Reaction mass of 2,4-dimethylphenol and 2,5-dimethylphenol",1638758-52-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0bbf540-0ae1-4637-b2f7-22da3de424ed/documents/IUC5-514b784d-5b0e-4dcc-8a13-10be527f6953_15632efe-6c48-4146-b493-62a4d025a4c4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Reaction mass of 2,4-dimethylphenol and 2,5-dimethylphenol",1638758-52-7,"Acute oral toxicity: Key study -mixed ethylphenols. York, 2005. KL.1. LD50 980.62mg/kg; NOEL 175mg/kg; Supporting study: mixed xylenols. York, 2005. KL.1 LD50 980.62mg/kg; NOEL 175mg/kg; Supporting study: m-cresol. IBTL, 1969. KL.3. NOEL not identified. LOAEL 147mg/kg; Supporting study: o-cresol. IBTL, 1969. KL.3. NOEL not identified. LD50 121mg/kg; LOAEL 68mg/kg; Supporting study: p-cresol. IBTL, 1969. KL.3. NOEL not identified. LD50 207mg/kg; LOAEL 100mg/kg; Acute inhalation toxicity: No key or supporting studies identified; Acute dermal toxicity: No key or supporting studies identified; ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0bbf540-0ae1-4637-b2f7-22da3de424ed/documents/IUC5-c2ffa9e5-a83e-4a03-997e-aab657d5d508_15632efe-6c48-4146-b493-62a4d025a4c4.html,,,,,, "Reaction mass of 2,4-dimethylphenol and 2,5-dimethylphenol",1638758-52-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0bbf540-0ae1-4637-b2f7-22da3de424ed/documents/IUC5-c2ffa9e5-a83e-4a03-997e-aab657d5d508_15632efe-6c48-4146-b493-62a4d025a4c4.html,,oral,discriminating dose,175 mg/kg bw,, L-cystine dihydrochloride,30925-07-6, As the test item is corrosive to the skin no acute toxicity study was conducted. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/763c540e-7a1d-4bf8-940d-4211ad754e0a/documents/5ad47e15-f8c2-488f-a821-bb9c13592239_6e4b3c83-def6-4cb8-a9a6-7f2c0f0ef04c.html,,,,,, "Leach residues, cadmium cake",91053-44-0,"Leach residues, cadmium cake is classified Acute oral Cat.3, H301 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d23f965e-0585-4b48-a024-cdef8dda3761/documents/IUC5-5ae54316-bb14-4a75-859e-192d4b338831_bb15dfc3-cd8d-4c6e-bf03-4a0c40f33583.html,,,,,, "Leach residues, zinc ore, lead-contg.",91053-49-5,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e17d0af2-c1c4-41ee-935f-835dc449a460/documents/dad2de6f-3203-4346-b110-e76201b2afda_c481dbe4-7c1a-4ebb-992f-725ff75b9e51.html,,,,,, "Leach residues, zinc ore, lead-contg.",91053-49-5,The acute toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e17d0af2-c1c4-41ee-935f-835dc449a460/documents/8a5b3ff0-13a6-4d67-b0ae-121db7f0c145_c481dbe4-7c1a-4ebb-992f-725ff75b9e51.html,,,,,, "Leach residues, zinc ore-calcine, zinc cobalt",69012-72-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7633a123-69e7-4bbc-88f4-b4692a082225/documents/04b8e8de-c5d2-4439-b804-af8ad09b6684_e99191a5-663f-409c-a047-0217abd23616.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.013 mg/m3,,"hamster, Syrian" "Leach residues, zinc ore-calcine, zinc cobalt",69012-72-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7633a123-69e7-4bbc-88f4-b4692a082225/documents/04b8e8de-c5d2-4439-b804-af8ad09b6684_e99191a5-663f-409c-a047-0217abd23616.html,Chronic toxicity – systemic effects,oral,NOAEL,0.12 mg/kg bw/day,,monkey "Leach residues, zinc ore-calcine, zinc cobalt",69012-72-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7633a123-69e7-4bbc-88f4-b4692a082225/documents/1a91dd27-a69b-4275-ad75-c156da648ad3_e99191a5-663f-409c-a047-0217abd23616.html,,oral,LD50,"2,330 mg/kg bw",, "Leach residues, zinc ore-calcine, zinc cobalt",69012-72-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7633a123-69e7-4bbc-88f4-b4692a082225/documents/1a91dd27-a69b-4275-ad75-c156da648ad3_e99191a5-663f-409c-a047-0217abd23616.html,,inhalation,LC50,56 mg/m3,, "Lead alloy, base, Pb,Sn, dross",69011-60-5, Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in the respective Section 7 Summaries. At least one component has reliable and good quality evidence from human cases or epidemiological studies or animal studies with significant and/or severe toxic effects at low oral/inhalation exposure concentrations. Waivers are in place for inhalation and dermal studies. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69825b61-0599-4341-ba7e-fa591bef7cfb/documents/IUC5-07492dd8-04c2-4296-9fd9-82758ea1fdb3_fb9c6980-8e80-427f-b31f-096e6cfbd89d.html,,,,,, "Lead alloy, base, Pb,Sn, dross",69011-60-5, The acute toxicity is driven by the characteristics of the individual UVCB constituents.  Relevant information on the individual UVCB constituents is reported in the respective Section 7 Summaries. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69825b61-0599-4341-ba7e-fa591bef7cfb/documents/IUC5-bea04008-fee8-4d14-ba6c-a39138e241a3_fb9c6980-8e80-427f-b31f-096e6cfbd89d.html,,,,,, Lead bis(tetrafluoroborate),13814-96-5,"The substance as registered is considered to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e72eaddb-c536-4347-b5d2-13ef3395a84e/documents/IUC5-58f55815-e510-4d7f-b9ba-dffc55339135_9cf68dc0-b416-41a1-b0f3-fa5f1a6c7bdf.html,,,,,, Lead bis(tetrafluoroborate),13814-96-5,"Acute toxicity, oral: LD50 2000 mg/kg bwAcute toxicity, inhalation: data waivingAcute toxicity, dermal: data waiving ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e72eaddb-c536-4347-b5d2-13ef3395a84e/documents/IUC5-2b146910-a5fe-4c3b-bb87-de898850234d_9cf68dc0-b416-41a1-b0f3-fa5f1a6c7bdf.html,,,,,, Lead dichloride,7758-95-4," Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66f6ccfa-0e67-4768-a88c-624ea9c7492c/documents/55240df1-e7fa-4fe8-8269-766f9e1416fc_5c8e0fd4-4bec-4eaf-a3ef-b83ff2bc4203.html,,,,,, Lead dichloride,7758-95-4, Inorganic lead compounds do not exhibit toxicity in acute toxicity tests with experimental animals. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66f6ccfa-0e67-4768-a88c-624ea9c7492c/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_5c8e0fd4-4bec-4eaf-a3ef-b83ff2bc4203.html,,,,,, Lead dichloride,7758-95-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66f6ccfa-0e67-4768-a88c-624ea9c7492c/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_5c8e0fd4-4bec-4eaf-a3ef-b83ff2bc4203.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Lead dichloride,7758-95-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66f6ccfa-0e67-4768-a88c-624ea9c7492c/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_5c8e0fd4-4bec-4eaf-a3ef-b83ff2bc4203.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Lead dichloride,7758-95-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66f6ccfa-0e67-4768-a88c-624ea9c7492c/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_5c8e0fd4-4bec-4eaf-a3ef-b83ff2bc4203.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Lead dinitrate,10099-74-8,"Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da9434ac-dcaf-40e7-8756-db90ceaf0e10/documents/IUC5-58c62a5b-cfe6-4203-9114-d8b2504a7724_3500d4e6-016b-4d69-9b81-c0fb21c6fffe.html,,,,,, Lead dinitrate,10099-74-8,Inorganic lead compounds do not exhit toxicity in acute toxicity tests with experimental animals. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da9434ac-dcaf-40e7-8756-db90ceaf0e10/documents/IUC5-6e1cdba4-86ac-405a-a775-11672718696e_3500d4e6-016b-4d69-9b81-c0fb21c6fffe.html,,,,,, Lead dioxide,1309-60-0,"No acute oral toxicity study is available on the target substance Lead dioxide. An acute oral toxicity study is available on the analogue substance Lead monoxide (OECD 423 TG). Based on the read across key study performed on the analogue Lead monoxide (BIEN 2003, OECD TG 423, Klimisch 1), the target substance Lead dioxide is not considered to be acutely hazardous via the oral route (oral LD50 > 2000 mg/kg bw) (no mortality, no clinical signs, no effects on body weights, no macroscopic changes at necropsy).There are no inhalation or dermal acute toxicity studies performed on the registered substance Lead dioxide. Based on the tonnage band of the registered substance (1-10 tpa) and requirements of Annex VII of REACh, acute toxicity studies via the inhalation and dermal routes are not required. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8a49c59-4c04-482d-9931-be0d7151692a/documents/4d460e3b-57f0-453c-a6d1-e99b978f3219_94994fdd-240b-498c-9f20-daa92728c086.html,,,,,, Lead dioxide,1309-60-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8a49c59-4c04-482d-9931-be0d7151692a/documents/4d460e3b-57f0-453c-a6d1-e99b978f3219_94994fdd-240b-498c-9f20-daa92728c086.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Lead monoxide,1317-36-8," Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b44809a3-2368-4044-90aa-1b8dc29d5dd5/documents/55240df1-e7fa-4fe8-8269-766f9e1416fc_6dad92c0-835c-4759-89de-637bf19ffa5b.html,,,,,, Lead monoxide,1317-36-8, Inorganic lead compounds do not exhibit toxicity in acute toxicity tests with experimental animals. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b44809a3-2368-4044-90aa-1b8dc29d5dd5/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_6dad92c0-835c-4759-89de-637bf19ffa5b.html,,,,,, Lead monoxide,1317-36-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b44809a3-2368-4044-90aa-1b8dc29d5dd5/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_6dad92c0-835c-4759-89de-637bf19ffa5b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Lead monoxide,1317-36-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b44809a3-2368-4044-90aa-1b8dc29d5dd5/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_6dad92c0-835c-4759-89de-637bf19ffa5b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Lead monoxide,1317-36-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b44809a3-2368-4044-90aa-1b8dc29d5dd5/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_6dad92c0-835c-4759-89de-637bf19ffa5b.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Lead oxide sulfate,12036-76-9," Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9f5e331-df52-4225-a7c2-c7953b4ae3f9/documents/55240df1-e7fa-4fe8-8269-766f9e1416fc_1815fb30-8730-473a-9da1-67e67c0ad82c.html,,,,,, Lead oxide sulfate,12036-76-9, Inorganic lead compounds do not exhibit toxicity in acute toxicity tests with experimental animals. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9f5e331-df52-4225-a7c2-c7953b4ae3f9/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_1815fb30-8730-473a-9da1-67e67c0ad82c.html,,,,,, Lead oxide sulfate,12036-76-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9f5e331-df52-4225-a7c2-c7953b4ae3f9/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_1815fb30-8730-473a-9da1-67e67c0ad82c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Lead oxide sulfate,12036-76-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9f5e331-df52-4225-a7c2-c7953b4ae3f9/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_1815fb30-8730-473a-9da1-67e67c0ad82c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Lead oxide sulfate,12036-76-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9f5e331-df52-4225-a7c2-c7953b4ae3f9/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_1815fb30-8730-473a-9da1-67e67c0ad82c.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Lead tetraacetate,546-67-8,"Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/58399aba-688d-4e2a-ab8b-54163a229529/documents/IUC5-87324174-965e-451d-b523-6e8a2fba0e19_1157b2ad-de15-4d3e-bbd2-4a5928e12382.html,,,,,, Lead tetraacetate,546-67-8,Inorganic lead compounds do not exhit toxicity in acute toxicity tests with experimental animals. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58399aba-688d-4e2a-ab8b-54163a229529/documents/IUC5-9ebf53b1-5a3f-46bc-a37e-007ad3c4d495_1157b2ad-de15-4d3e-bbd2-4a5928e12382.html,,,,,, Lead titanium trioxide,12060-00-3,"Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function including the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bec11e15-63c2-4b4e-a2f3-892b4a5dd370/documents/IUC5-5556f16e-2f2f-4ce3-b59b-da6c5d6e08ca_fad458a7-3910-478a-af71-c5686874a610.html,,,,,, Lead titanium trioxide,12060-00-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bec11e15-63c2-4b4e-a2f3-892b4a5dd370/documents/IUC5-5556f16e-2f2f-4ce3-b59b-da6c5d6e08ca_fad458a7-3910-478a-af71-c5686874a610.html,Chronic toxicity – systemic effects,oral,LOAEL,0.005 mg/kg bw/day,,rat Lead titanium trioxide,12060-00-3,Inorganic lead compounds do not exhit toxicity in acute toxicity tests with experimental animals. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bec11e15-63c2-4b4e-a2f3-892b4a5dd370/documents/IUC5-6d5a23a5-ea35-4ff8-85ee-508ad4aaa770_fad458a7-3910-478a-af71-c5686874a610.html,,,,,, Lead titanium trioxide,12060-00-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bec11e15-63c2-4b4e-a2f3-892b4a5dd370/documents/IUC5-6d5a23a5-ea35-4ff8-85ee-508ad4aaa770_fad458a7-3910-478a-af71-c5686874a610.html,,oral,LD50,"5,000 mg/kg bw",, Lead titanium trioxide,12060-00-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bec11e15-63c2-4b4e-a2f3-892b4a5dd370/documents/IUC5-6d5a23a5-ea35-4ff8-85ee-508ad4aaa770_fad458a7-3910-478a-af71-c5686874a610.html,,dermal,LD50,"2,000 mg/kg bw",, Lead titanium trioxide,12060-00-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bec11e15-63c2-4b4e-a2f3-892b4a5dd370/documents/IUC5-6d5a23a5-ea35-4ff8-85ee-508ad4aaa770_fad458a7-3910-478a-af71-c5686874a610.html,,inhalation,LC50,"5,050 mg/m3",, Lead titanium zirconium oxide,12626-81-2,"Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function including the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb6c23ba-5635-4e45-9d42-9a701532c0a2/documents/IUC5-e03ebec8-a826-4b70-bb5b-8cae15d83d19_a860608a-343d-4d29-9fe2-d23ffe44f5c2.html,,,,,, Lead titanium zirconium oxide,12626-81-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb6c23ba-5635-4e45-9d42-9a701532c0a2/documents/IUC5-e03ebec8-a826-4b70-bb5b-8cae15d83d19_a860608a-343d-4d29-9fe2-d23ffe44f5c2.html,Chronic toxicity – systemic effects,oral,LOAEL,0.005 mg/kg bw/day,,rat Lead titanium zirconium oxide,12626-81-2,Inorganic lead compounds do not exhibit toxicity in acute toxicity tests with experimental animals. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb6c23ba-5635-4e45-9d42-9a701532c0a2/documents/IUC5-049aa130-3b87-45b1-acd1-2f8458302eff_a860608a-343d-4d29-9fe2-d23ffe44f5c2.html,,,,,, Lead titanium zirconium oxide,12626-81-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb6c23ba-5635-4e45-9d42-9a701532c0a2/documents/IUC5-049aa130-3b87-45b1-acd1-2f8458302eff_a860608a-343d-4d29-9fe2-d23ffe44f5c2.html,,oral,LD50,"2,001 mg/kg bw",no adverse effect observed, Lead titanium zirconium oxide,12626-81-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb6c23ba-5635-4e45-9d42-9a701532c0a2/documents/IUC5-049aa130-3b87-45b1-acd1-2f8458302eff_a860608a-343d-4d29-9fe2-d23ffe44f5c2.html,,dermal,LD50,"2,001 mg/kg bw",no adverse effect observed, Lead titanium zirconium oxide,12626-81-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb6c23ba-5635-4e45-9d42-9a701532c0a2/documents/IUC5-049aa130-3b87-45b1-acd1-2f8458302eff_a860608a-343d-4d29-9fe2-d23ffe44f5c2.html,,inhalation,LC50,5.05 mg/m3,no adverse effect observed, "Lead, antimonial, dross",69029-51-2,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f846b01-405a-45d5-bd9d-1465cb85e384/documents/IUC5-671db794-de49-4907-9e66-bd0dea4c33bf_3a632928-9685-4760-a2cc-404231e0f204.html,,,,,, "Lead, antimonial, dross",69029-51-2,"Complex substance containing metals. The classification is based on assessment of the components, treating it as a mixture.Considered to be toxic if ingested and harmful if inhaled. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f846b01-405a-45d5-bd9d-1465cb85e384/documents/IUC5-1fc4c4cf-3fc9-4e5f-93cb-26c12ddb364e_3a632928-9685-4760-a2cc-404231e0f204.html,,,,,, "Lead, bullion",97808-88-3, Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Information on the individual UVCB constituents is reported in the relevant Section 7 Summaries. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e714867-e420-47d9-863f-aa98d2fa2592/documents/IUC5-eb126776-8084-48cd-acbf-56d9d522c95f_fcb0e2af-36e8-49cb-8728-d71105a27b65.html,,,,,, "Lead, bullion",97808-88-3, The acute toxicity is driven by the characteristics of the individual UVCB constituents. Information on the individual UVCB constituents is reported in the relevant Section 7 Summaries. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e714867-e420-47d9-863f-aa98d2fa2592/documents/IUC5-b0e3d7f6-8223-48e8-a0f8-a282e212e1aa_fcb0e2af-36e8-49cb-8728-d71105a27b65.html,,,,,, "Lead, dross",69029-52-3, Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents.  Relevant information on the individual UVCB constituents is reported in Section 7 Summaries. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a98ab5ed-bf19-46f6-9877-8bf44fc9dfae/documents/IUC5-6956aacf-42b7-43b6-a8f9-8010dcabe67b_21ed4991-817b-4135-a34e-ed1b18266d94.html,,,,,, "Lead, dross",69029-52-3, The acute toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a98ab5ed-bf19-46f6-9877-8bf44fc9dfae/documents/IUC5-8b9b29af-d990-4138-b230-83ed2d5b6c34_21ed4991-817b-4135-a34e-ed1b18266d94.html,,,,,, "Lead, dross, antimony-rich",69029-45-4,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1827d25-64a2-4809-8785-37db9492b079/documents/IUC5-1a0eab77-1cc1-4db5-a554-f294109590c4_2d633dfd-3ff6-47a0-98e2-99c69c419dde.html,,,,,, "Lead, dross, antimony-rich",69029-45-4,The acute toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1827d25-64a2-4809-8785-37db9492b079/documents/IUC5-507cbe57-ecce-463e-8c82-47fd34f1309c_2d633dfd-3ff6-47a0-98e2-99c69c419dde.html,,,,,, "Lead, dross, bismuth-rich",69029-46-5, Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. Substance is classified STOT-RE ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b64b789-9823-4b90-853e-47866201421a/documents/IUC5-8c16e753-3e7f-4460-896e-38ddab5d9ec2_db6c1a5f-37a0-4106-a52e-fe12aea133eb.html,,,,,, "Lead, dross, bismuth-rich",69029-46-5," The acute toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. The substance is classified Cat. 4 Oral and Inhalation, but does not meet CLP classification criteria for dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b64b789-9823-4b90-853e-47866201421a/documents/IUC5-ca9b971c-2bd8-4f04-9c78-9e966cb35e95_db6c1a5f-37a0-4106-a52e-fe12aea133eb.html,,,,,, "Lead, dross, copper-rich",69227-11-8,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. At least one component has reliable and good quality evidence from human cases or epidemiological studies or animal studies with significant and/or severe toxic effects at low exposure concentrations (inhalation; oral). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3eef2c03-5761-43db-a6a9-00fd5d034006/documents/IUC5-2000dc73-fb55-4012-8da5-356d58bb488a_212274fd-79a9-463c-8aca-d18cf3422fea.html,,,,,, "Lead, dross, copper-rich",69227-11-8, The acute toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3eef2c03-5761-43db-a6a9-00fd5d034006/documents/IUC5-14d77b9c-4e87-4b89-b8ee-73e4330fe579_212274fd-79a9-463c-8aca-d18cf3422fea.html,,,,,, "Lecithins, acetylated",91053-50-8,"Repeated dose oral. OECD 422. No adverse effects observed up to 1000 mg/kg/day, the highest dose tested. Reliability = 1.No repeated dose dermal data available. No toxicity in dermal irritation or sensitisation study and dermal route not more acutely toxic than oral.No repeated dose inhalation data available. Inhalation route not more acutely toxic than oral. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c74d8ceb-34e7-40b8-936a-2c5a50c6963d/documents/IUC5-3bc5bc64-5fb1-47a6-9292-b9a22a3003b1_1bd83151-2406-4387-9739-d0406c8de540.html,,,,,, "Lecithins, acetylated",91053-50-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c74d8ceb-34e7-40b8-936a-2c5a50c6963d/documents/IUC5-3bc5bc64-5fb1-47a6-9292-b9a22a3003b1_1bd83151-2406-4387-9739-d0406c8de540.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Lecithins, acetylated",91053-50-8,Oral LD50 rat. No adverse effects observed. Not classified as acutely toxic by the oral route. Reliability = 1.Dermal LD50 rat. No adverse effects observed. Not classified as acutely toxic by the dermal route. Reliability = 1.Inhalation 4-hour LC50 rat. No adverse effects observed. Not classified as acutely toxic by the inhalation route. Reliability = 1. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c74d8ceb-34e7-40b8-936a-2c5a50c6963d/documents/IUC5-94f3b671-2eaa-430f-8222-027a68703c16_1bd83151-2406-4387-9739-d0406c8de540.html,,,,,, "Lecithins, acetylated",91053-50-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c74d8ceb-34e7-40b8-936a-2c5a50c6963d/documents/IUC5-94f3b671-2eaa-430f-8222-027a68703c16_1bd83151-2406-4387-9739-d0406c8de540.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Lecithins, acetylated",91053-50-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c74d8ceb-34e7-40b8-936a-2c5a50c6963d/documents/IUC5-94f3b671-2eaa-430f-8222-027a68703c16_1bd83151-2406-4387-9739-d0406c8de540.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Lecithins, acetylated",91053-50-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c74d8ceb-34e7-40b8-936a-2c5a50c6963d/documents/IUC5-94f3b671-2eaa-430f-8222-027a68703c16_1bd83151-2406-4387-9739-d0406c8de540.html,,inhalation,LC50,890 mg/m3,no adverse effect observed, "Leuco polysulfided 4-[(2,4-dinitrophenyl)amino]phenol",61902-31-6," Under the conditions of an OECD 422 compliant study, the test item (Leuco Sulphur Yellow 22, CAS 90268 -98 -7, source substance for read across to Leuco Sulphur Blue 11) administered at 100, 300 or 1000 mg/kg bw/day (corrected doses; corresponding to uncorrected doses of 110.46, 331.38 and 1104.61 mg/kg bw/day, respectively) by oral gavage did not cause signs of systemic toxicity and did not adversely influence the reproductive performance (gonad function, mating behavior, conception, parturition) in parental male and female Han:WIST rats. The development of the F1 offspring was not impaired from birth to post-natal day 13 at any dose level after repeated oral administration of dams. Based on these observations the No Observed Adverse Effect Levels (NOAEL) were determined as follows: NOAEL for systemic toxicity of male/female rats: 1000 mg/kg bw/day NOAEL for reproductive performance of male/ female rats: 1000 mg/kg bw/day NOAEL for F1 Offspring: 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a913fbc-e76b-4fb2-8878-9576df39388b/documents/2b6db15b-4eb8-4a78-afba-81fdb9badd62_2d4df3f9-a11b-4108-8d96-98e795f61ebb.html,,,,,, "Leuco polysulfided 4-[(2,4-dinitrophenyl)amino]phenol",61902-31-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a913fbc-e76b-4fb2-8878-9576df39388b/documents/2b6db15b-4eb8-4a78-afba-81fdb9badd62_2d4df3f9-a11b-4108-8d96-98e795f61ebb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Leuco polysulfided 4-[(2,4-dinitrophenyl)amino]phenol",61902-31-6," In an in vivo acute toxicity assay (acute toxicity class method, ATC) according to OECD guideline 423, an LD50 of above 2000 mg dyestuff/kg bw, corresponnding to 2160 mg test item/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a913fbc-e76b-4fb2-8878-9576df39388b/documents/c9887300-456d-4792-9aba-881d47316bd2_2d4df3f9-a11b-4108-8d96-98e795f61ebb.html,,,,,, "Leuco polysulfided 4-[(2,4-dinitrophenyl)amino]phenol",61902-31-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a913fbc-e76b-4fb2-8878-9576df39388b/documents/c9887300-456d-4792-9aba-881d47316bd2_2d4df3f9-a11b-4108-8d96-98e795f61ebb.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "16-[[(1S)-1-carboxy-4-(2,5-dioxopyrrolidin-1-yl)oxy-4-oxo-butyl]amino]-16-oxo-hexadecanoic acid",943586-12-7,The acute oral median lethal dose (LD50) of PC2414 was estimated to be greater than 2000 mg/kg bw. In accordance with the Globally Harmonised Classification System PC2414 is not classified. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec48b778-b387-408f-badb-204515d0046d/documents/IUC5-ac5f6d6f-64ce-42f6-9518-2122ebccc80d_243250e6-b273-4c3a-bbad-b823b0e4edeb.html,,,,,, "16-[[(1S)-1-carboxy-4-(2,5-dioxopyrrolidin-1-yl)oxy-4-oxo-butyl]amino]-16-oxo-hexadecanoic acid",943586-12-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec48b778-b387-408f-badb-204515d0046d/documents/IUC5-ac5f6d6f-64ce-42f6-9518-2122ebccc80d_243250e6-b273-4c3a-bbad-b823b0e4edeb.html,,oral,LD50,"2,000 mg/kg bw",, Diethyl N-[4-(4-oxobutyl)benzoyl]-L-glutamate,908145-87-9,"Based on test data from Acute Toxic Class Determination Study, Intermediate is not classified as acutely toxic under EU CLP Regulations ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbffb344-6cf5-49dd-829d-ec962dfc34d4/documents/IUC5-f585893a-b7dc-428e-a76c-9e11c38451e5_ff2ae7a1-37e2-49ee-bfd7-8cfecb53aee1.html,,,,,, Diethyl N-[4-(4-oxobutyl)benzoyl]-L-glutamate,908145-87-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bbffb344-6cf5-49dd-829d-ec962dfc34d4/documents/IUC5-f585893a-b7dc-428e-a76c-9e11c38451e5_ff2ae7a1-37e2-49ee-bfd7-8cfecb53aee1.html,,oral,LD50,"2,000 mg/kg bw",, Licheninase,37288-51-0," The acute oral toxicity of licheninase has not been studied. However, a read-across approach was used with enzymes alpha-amylase, cellulase and xylanase, all belonging to glcosidases (IUB 3.2.1). For alpha-amylase: No signs of toxicity were observed among the rats treated with a single oral dose of 1911 mg total organic solids/kg, which was the highest possible dose at dose volume 20 mL/kg, using the undiluted test item. For cellulase: The acute oral lethal dosage (LD50) of cellulase was greater than 2880 mg Total Organic Solids (TOS)/kg bw. For xylanase: No signs of toxicity were observed among the rats treated with a single oral dose of 2102 mg total organic solids/kg, which was the highest possible dose at dose volume 20.6 mL/kg, using the undiluted test item. Due to the similarities between the enzymes, it can be concluded that the toxicity of licheninase will be similar to the above-mentioned enzymes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7116a54-4d7d-413c-83fa-a59cabe7760d/documents/5b8b070e-be68-4175-b6cb-0e07add0c2bc_d567b0e7-dc75-411b-9024-0fa4387adcde.html,,,,,, "Lime (chemical), hydraulic",85117-09-5," Toxicity of calcium via the oral route is addressed by upper intake levels (UL) for adults determined by the Scientific Committee on Food (SCF), being UL = 2500 mg/d, corresponding to 36 mg/kg bw/d (70 kg person) for calcium. Toxicity of lime (chemical) hydraulic via the dermal route is not considered as relevant in view of the anticipated negligible absorption through skin. Toxicity of lime (chemical) hydraulic via inhalation (local effect, irritation of mucous membranes) is addressed by an IOELV of 1 mg/m³ respirable fraction (8h-TWA) (Commission Directive (EU) 2017/164 of 31 January 2017). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c6cad0f-ec60-4390-8259-33cf60e60d8c/documents/48532b43-2757-4f96-88df-8ecc267e1227_20a87644-d0ff-4049-8126-f6dd7db89ae1.html,,,,,, "Lime (chemical), hydraulic",85117-09-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c6cad0f-ec60-4390-8259-33cf60e60d8c/documents/48532b43-2757-4f96-88df-8ecc267e1227_20a87644-d0ff-4049-8126-f6dd7db89ae1.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,107 mg/m3,,rat "Lime (chemical), hydraulic",85117-09-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c6cad0f-ec60-4390-8259-33cf60e60d8c/documents/48532b43-2757-4f96-88df-8ecc267e1227_20a87644-d0ff-4049-8126-f6dd7db89ae1.html,Repeated dose toxicity – local effects,inhalation,NOAEC,107 mg/m3,no adverse effect observed,rat "Lime (chemical), hydraulic",85117-09-5," Lime (chemical) hydraulic is not acutely toxic via oral, inhalation or dermal routes. Acute oral toxicity: LD50 (rat) > 2000 mg/kg bw for calcium dihydroxide (Arcelin, 2007); read across to lime (chemical) hydraulic LD50 (rat) > 2000 mg/kg bw for calcium carbonate (Bradshaw, 2008) Acute inhalation toxicity: 4 -h LC50 (rat) >6.04 mg/L air for Flue dust, Portland cement (EC 270 -659 -9)(TNO, 2010); read across to lime (chemical) hydraulic 4 -h LC50 (rat) >3 mg/L air (highest technically achievable concentration) for calcium carbonate (Schuler, 2010) Acute dermal toxicity: LD50 (rabbit) > 2500 mg/kg bw for calcium dihydroxide (Kietzmann, 1994); read across to lime (chemical) hydraulic LD50 (rat) > 2000 mg/kg bw for calcium carbonate (Bradshaw, 2010) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c6cad0f-ec60-4390-8259-33cf60e60d8c/documents/574cecca-f516-496c-b5db-f66a6fa866e1_20a87644-d0ff-4049-8126-f6dd7db89ae1.html,,,,,, "Lime (chemical), hydraulic",85117-09-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c6cad0f-ec60-4390-8259-33cf60e60d8c/documents/574cecca-f516-496c-b5db-f66a6fa866e1_20a87644-d0ff-4049-8126-f6dd7db89ae1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Lime (chemical), hydraulic",85117-09-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c6cad0f-ec60-4390-8259-33cf60e60d8c/documents/574cecca-f516-496c-b5db-f66a6fa866e1_20a87644-d0ff-4049-8126-f6dd7db89ae1.html,,dermal,LD50,"2,500 mg/kg bw",adverse effect observed, "Lime (chemical), hydraulic",85117-09-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c6cad0f-ec60-4390-8259-33cf60e60d8c/documents/574cecca-f516-496c-b5db-f66a6fa866e1_20a87644-d0ff-4049-8126-f6dd7db89ae1.html,,inhalation,LC50,"6,040 mg/m3",no adverse effect observed, "Linseed oil, epoxidized",8016-11-3, A combined repeated dose toxicity with the reproduction/developmental toxicity screening test was carried out on rats  according to OECD test guideline 422. A combined chronic toxicity/carcinogenicity study was carried out according to OECD test guideline 453. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/297e43d7-5851-4ba8-bd8b-05d42534bad5/documents/IUC5-a3a00cb8-109f-4277-8883-f352aa087cc7_c3a94839-2faa-45da-8a8d-5f9c26e2277c.html,,,,,, "Linseed oil, epoxidized",8016-11-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/297e43d7-5851-4ba8-bd8b-05d42534bad5/documents/IUC5-a3a00cb8-109f-4277-8883-f352aa087cc7_c3a94839-2faa-45da-8a8d-5f9c26e2277c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Linseed oil, epoxidized",8016-11-3," Studies of acute oral toxicity and acute dermal toxicity are available. A study of acute inhalation toxicity is not required, on exposure grounds. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/297e43d7-5851-4ba8-bd8b-05d42534bad5/documents/IUC5-f75a698c-fd9f-4942-901b-ae40b6a5e13c_c3a94839-2faa-45da-8a8d-5f9c26e2277c.html,,,,,, "Linseed oil, epoxidized",8016-11-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/297e43d7-5851-4ba8-bd8b-05d42534bad5/documents/IUC5-f75a698c-fd9f-4942-901b-ae40b6a5e13c_c3a94839-2faa-45da-8a8d-5f9c26e2277c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Linseed oil, epoxidized",8016-11-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/297e43d7-5851-4ba8-bd8b-05d42534bad5/documents/IUC5-f75a698c-fd9f-4942-901b-ae40b6a5e13c_c3a94839-2faa-45da-8a8d-5f9c26e2277c.html,,dermal,LD50,"20,000 mg/kg bw",no adverse effect observed, "Linseed oil, ester with pentaerythritol",68648-28-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Good quality studies ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c6e6269-9f3e-496a-ab21-7073284514f7/documents/b7fee18f-f463-40e9-b530-96d9cc30913d_2fd1ea14-1b28-4789-9084-e5abba7c9c15.html,,,,,, "Linseed oil, ester with pentaerythritol",68648-28-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c6e6269-9f3e-496a-ab21-7073284514f7/documents/b7fee18f-f463-40e9-b530-96d9cc30913d_2fd1ea14-1b28-4789-9084-e5abba7c9c15.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,450 mg/kg bw/day",,rat "Linseed oil, ester with pentaerythritol",68648-28-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c6e6269-9f3e-496a-ab21-7073284514f7/documents/8865cd9a-ac00-44fa-a19c-911ba0fb8ad6_2fd1ea14-1b28-4789-9084-e5abba7c9c15.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Linseed oil, oxidized",68649-95-6,OECD 422: no evidence of repeated dose toxicity (NOAEL: >1000 mg/kg bw/day) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3f8ff56-cb75-4c5f-90e0-4c5aa60c19b2/documents/IUC5-bb4112dc-471b-430e-b989-ec31b02f9fac_b0b20c8c-4cca-48a6-9d65-fff47aa99e02.html,,,,,, "Linseed oil, oxidized",68649-95-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3f8ff56-cb75-4c5f-90e0-4c5aa60c19b2/documents/IUC5-bb4112dc-471b-430e-b989-ec31b02f9fac_b0b20c8c-4cca-48a6-9d65-fff47aa99e02.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Linseed oil, oxidized",68649-95-6, Acute toxicity (oral): the results of the 2 studies (OECD 401) are >4790 and >4986 mg/kg. The lowest is assigned as key value for the CSA. Acute toxicity (dermal): the result of the study is >2000 mg/kg (OECD 402) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3f8ff56-cb75-4c5f-90e0-4c5aa60c19b2/documents/IUC5-bfe98607-61f1-450b-9f06-b35625358957_b0b20c8c-4cca-48a6-9d65-fff47aa99e02.html,,,,,, "Linseed oil, oxidized",68649-95-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3f8ff56-cb75-4c5f-90e0-4c5aa60c19b2/documents/IUC5-bfe98607-61f1-450b-9f06-b35625358957_b0b20c8c-4cca-48a6-9d65-fff47aa99e02.html,,oral,LD50,"4,790 mg/kg bw",, "Linseed oil, oxidized",68649-95-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3f8ff56-cb75-4c5f-90e0-4c5aa60c19b2/documents/IUC5-bfe98607-61f1-450b-9f06-b35625358957_b0b20c8c-4cca-48a6-9d65-fff47aa99e02.html,,dermal,LD50,"2,000 mg/kg bw",, Lithium,7439-93-2," Based on human data obtained from long–term routine treatment of bipolar disorder with lithium (administered as lithium carbonate), a NOAEL for long-term oral toxicity of 1.2 mg lithium/kg bw/ day was calculated. Performance of repeated dermal and inhalation toxicity studies were waived. For CSA requirements NOAEL for long-term dermal toxicity and NOAEC for long-term inhalation toxicity were calculated based on the NOAEL value of 1.2 mg/kg bw/day determined for long-term oral toxicity. A NOAEL value of 12 mg/kg bw/day was calculated for long term dermal toxicity and a NOAEC value of 4.2 mg/m³ were calculated for long-term inhalation toxicity (worker). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58661aec-6e7d-4db6-953a-7694b3398e39/documents/a4e15530-e8ea-470c-9e00-d6a57cf7907b_e428a0b1-6007-440c-9cbf-d05b46f89d46.html,,,,,, Lithium,7439-93-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58661aec-6e7d-4db6-953a-7694b3398e39/documents/a4e15530-e8ea-470c-9e00-d6a57cf7907b_e428a0b1-6007-440c-9cbf-d05b46f89d46.html,Chronic toxicity – systemic effects,oral,NOAEL,1.2 mg/kg bw/day,,other:human Lithium,7439-93-2," 1. In accordance with column 2 of REACH Regulation 1907/2006/EC Annex VII section 8.5 and in line with animal welfare, an acute toxicity study by oral route does not need to be conducted as lithium is classified as corrosive to the skin according to Regulation (EC) No 1272/2008 CLP (Cat. 1B, H314) and according to Directive 67/548/EEC (R34). Additionally, performance of an acute oral study can be waived under REACH (Annex XI)  as exposure can be excluded because of applied RMM due to substance properties (corrosive, flammable in contact with water)   2. In accordance with column 2 of REACH Regulation 1907/2006/EC Annex VII section 8.5 and in line with animal welfare, an acute toxicity study by inhalation route does not need to be conducted as lithium obtain hygroscopic properties that cause burnes, it is known to be corrosive and is classified as corrosive to the skin according to Regulation (EC) No 1272/2008 CLP (Cat. 1B, H314) and according to Directive 67/548/EEC (R34). Further the calculated vapour pressure of 3.49E-29 Pa  at 25 °C (EPIWIN) is very low  therefore lithium has a very low potential to be inhaled.  3. In accordance with column 2 of REACH Regulation 1907/2006/EC Annex VII section 8.5 an acute toxicity study by dermal route does not need to be conducted as lithium is known to obtain hygroscopic and corrosive properties and is therefore classified as corrosive to the skin according to Regulation (EC) No 1272/2008 CLP (Cat. 1B, H314) and according to Directive 67/548/EEC (R34). Additionally, the physiochemical and toxicological properties of lithium ion suggest no potential for a significant rate of absorption through the skin and no acute toxicity dermal hazard was evident from an acute toxicity dermal study with lithium carbonate. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58661aec-6e7d-4db6-953a-7694b3398e39/documents/51a5ad97-d116-4ab5-a83a-21baf1dbec65_e428a0b1-6007-440c-9cbf-d05b46f89d46.html,,,,,, "Lithium [ethanedioato-O,O’]tetrafluorophosphate",521065-36-1,"Repeated oral toxicity: The test item administrated at 40 mg/kg b.w./day for a 28-day period caused significant and irreversible lesions in kidneys both in male and female rats. The target organ in male and female rats for the test item is both kidneys. The test item administrated at 20 mg/kg b.w./day for a 28-day period produced no significant toxic changes or delayed toxic effects. Therefore under the conditions of this study, the no-observed-adverse-effect-level (NOAEL) for the test item in repeated dose 28-day oral toxicity study in SD rats was considered to be 20 mg/kg b.w./day for both male and female rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable without restrictions ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ee3f785-63a4-4cfe-8a00-0376197f240f/documents/06456734-ebe5-4b8d-9310-e2f07e4f708f_6363de1c-61d0-499c-b93b-5f2961bf82d5.html,,,,,, "Lithium [ethanedioato-O,O’]tetrafluorophosphate",521065-36-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ee3f785-63a4-4cfe-8a00-0376197f240f/documents/06456734-ebe5-4b8d-9310-e2f07e4f708f_6363de1c-61d0-499c-b93b-5f2961bf82d5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "Lithium [ethanedioato-O,O’]tetrafluorophosphate",521065-36-1, Oral: The acute oral toxicity of test item to the rat was assessed based on the method as described in OECD 423. The acute median lethal oral dose (LD50) to rats of test item was demonstrated to be between 50 and 300 mg/kg bodyweight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ee3f785-63a4-4cfe-8a00-0376197f240f/documents/d6040b8d-790f-4851-9ea5-56b874255f77_6363de1c-61d0-499c-b93b-5f2961bf82d5.html,,,,,, "Lithium [ethanedioato-O,O’]tetrafluorophosphate",521065-36-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ee3f785-63a4-4cfe-8a00-0376197f240f/documents/d6040b8d-790f-4851-9ea5-56b874255f77_6363de1c-61d0-499c-b93b-5f2961bf82d5.html,,oral,LD50,50 mg/kg bw,adverse effect observed, Lithium 12-hydroxystearate,7620-77-1,"OECD 422 combined repeat dose and reproductive toxicity screening studies have been conducted on key substances which fall in the definition of the Lithium salts of monocarboxylic acids C14-C22 category. Studies were conducted via oral gavage on lithium myristate, fatty acids C16-18 lithium salts and fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. A study via dietary administration was conducted on lithium 12-hydroxystearate and a dermal study was conducted on fatty acids C18-(unsaturated) lithium salts. The NOAEL was >=500 mg/kg body weight/day for lithium myristate and fatty acids C16-18 lithium salts and was 250 mg/kg body weight/day for fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. The NOAEL for lithium 12-hydroxystearate was 2000 ppm (144 and 161 mg/kg body weight/day for males and females, respectively) based on parental body weights. The NOAEL for fatty acids C18-(unsaturated) lithium salts was 1089.75 mg/kg body weight/day based on systemic effects and 111.25 mg/kg body weight/day based on dermal scores. The results for the tested substances have been read across to the other members of the lithium salts of monocarboxylic acids C14-C22 category. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4bf910ba-16e3-48a0-bf06-22c26a32063a/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_c57b2964-0cd3-4236-b98c-3dcd58eda2cc.html,,,,,, Lithium 12-hydroxystearate,7620-77-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4bf910ba-16e3-48a0-bf06-22c26a32063a/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_c57b2964-0cd3-4236-b98c-3dcd58eda2cc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,144 mg/kg bw/day,,rat Lithium 12-hydroxystearate,7620-77-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4bf910ba-16e3-48a0-bf06-22c26a32063a/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_c57b2964-0cd3-4236-b98c-3dcd58eda2cc.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,089.75 mg/kg bw/day",,rat Lithium 12-hydroxystearate,7620-77-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4bf910ba-16e3-48a0-bf06-22c26a32063a/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_c57b2964-0cd3-4236-b98c-3dcd58eda2cc.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.86 mg/cm2,adverse effect observed,rat Lithium 12-hydroxystearate,7620-77-1,"Oral acute toxicity studies in rats were conducted on lithium myristate, fatty acids C18-(unsaturated) lithium salts, lithium docosanoate, and fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. All studies reported no mortality and LD50 values greater than 2000 mg/kg bodyweight. These data have been read across to the other substances in the lithium salts of monocarboxylic acids C14-C22 category. A dermal toxicity study in rats was conducted on fatty acids C18-(unsaturated) lithium salts. The study reported no mortality and LD50 values greater than 2000 mg/kg bodyweight. These data have been read across to the other substances in the lithium salts of monocarboxylic acids C14-C22 category. An estimate of the inhalation dust/mist toxicity by route-to-route extrapolation using conservative standard default values results in an ATE of 10.4 mg/L/4 hours minimum. This value is well above the cut values for classification for acute inhalation toxicity hazard. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4bf910ba-16e3-48a0-bf06-22c26a32063a/documents/754e9131-4245-46c3-8876-e6b64b352e18_c57b2964-0cd3-4236-b98c-3dcd58eda2cc.html,,,,,, Lithium 12-hydroxystearate,7620-77-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4bf910ba-16e3-48a0-bf06-22c26a32063a/documents/754e9131-4245-46c3-8876-e6b64b352e18_c57b2964-0cd3-4236-b98c-3dcd58eda2cc.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Lithium 12-hydroxystearate,7620-77-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4bf910ba-16e3-48a0-bf06-22c26a32063a/documents/754e9131-4245-46c3-8876-e6b64b352e18_c57b2964-0cd3-4236-b98c-3dcd58eda2cc.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Lithium 2-aminobenzothiazole-6-sulphonate,65072-36-8," In an acute oral toxicity study in rats, conducted according to OECD test guideline 423 and to GLP, an LD50 value of equal to or greater than 2000 mg/kg bw was determined for lithium 2-aminobenzothiazole-6-sulphonate. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5970ad1-1e97-4413-af18-e8ca3f49c133/documents/75b421f3-f6cf-44ab-b1af-eed8ff25bb78_dc2e8b23-67f5-4c9d-9f27-a689ddf197d7.html,,,,,, Lithium 2-aminobenzothiazole-6-sulphonate,65072-36-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5970ad1-1e97-4413-af18-e8ca3f49c133/documents/75b421f3-f6cf-44ab-b1af-eed8ff25bb78_dc2e8b23-67f5-4c9d-9f27-a689ddf197d7.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "Lithium 4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonate",52236-73-4, Non harmful/toxic if swallowed. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3293b188-c6c1-4685-b11a-547e1121988a/documents/77b291ef-7ace-4c63-9b9e-0dae848b5d3f_dcef0d43-45f9-44c6-a631-e586b241e8f9.html,,,,,, "Lithium 4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonate",52236-73-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3293b188-c6c1-4685-b11a-547e1121988a/documents/77b291ef-7ace-4c63-9b9e-0dae848b5d3f_dcef0d43-45f9-44c6-a631-e586b241e8f9.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "Lithium 4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonate",52236-73-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3293b188-c6c1-4685-b11a-547e1121988a/documents/77b291ef-7ace-4c63-9b9e-0dae848b5d3f_dcef0d43-45f9-44c6-a631-e586b241e8f9.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Lithium acetate,546-89-4," Based on ADI/NOAEL values of lithium (human data), a NOAEL for long-term oral toxicity of 11.41 mg lithium acetate/kg bw/day and 17.64 mg lithium acetate dihydrate bw/day was calculated. Performance of repeated dermal and inhalation toxicity studies were waived.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07331d65-bc6f-48d8-8f81-94627e2dc974/documents/632aa89a-f922-4ea9-85ca-b94e69636b23_cac7ba7f-44f8-4a2b-8030-b021c6c34e89.html,,,,,, Lithium acetate,546-89-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/07331d65-bc6f-48d8-8f81-94627e2dc974/documents/632aa89a-f922-4ea9-85ca-b94e69636b23_cac7ba7f-44f8-4a2b-8030-b021c6c34e89.html,Chronic toxicity – systemic effects,oral,NOAEL,11.41 mg/kg bw/day,,other:Weight of evidence approach in which the NOAEL value is derived from reliable human data. Lithium acetate,546-89-4, Dermal: The dermal LD50 of the test item is greater than 2000 mg/kg. Oral: The oral LDLo of the test item was determined as 1500 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07331d65-bc6f-48d8-8f81-94627e2dc974/documents/29112951-f190-4c89-85a9-a45838ffc139_cac7ba7f-44f8-4a2b-8030-b021c6c34e89.html,,,,,, Lithium acetate,546-89-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07331d65-bc6f-48d8-8f81-94627e2dc974/documents/29112951-f190-4c89-85a9-a45838ffc139_cac7ba7f-44f8-4a2b-8030-b021c6c34e89.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, Lithium benzoate,553-54-8, Repeat dose toxicity appears to be driven by lithium Benzoate / benzoic acid is considered to be of low toxicity and any limits for exposure will be influenced by the presence of lithium. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/94958c81-74f1-4b60-a3e9-17bd91bdb13f/documents/c1617b74-2976-4b3b-a92b-70fc716767f9_bc5ebf2a-0fb7-4b67-8315-f3afc2b91ba9.html,,,,,, Lithium benzoate,553-54-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/94958c81-74f1-4b60-a3e9-17bd91bdb13f/documents/c1617b74-2976-4b3b-a92b-70fc716767f9_bc5ebf2a-0fb7-4b67-8315-f3afc2b91ba9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,mouse Lithium benzoate,553-54-8, Assessment has been made based on the well established toxicity profile of benzoate (specifically sodium benzoate) and lithium salts. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94958c81-74f1-4b60-a3e9-17bd91bdb13f/documents/6aefb377-c055-412c-a516-3940866d8911_bc5ebf2a-0fb7-4b67-8315-f3afc2b91ba9.html,,,,,, Lithium benzoate,553-54-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94958c81-74f1-4b60-a3e9-17bd91bdb13f/documents/6aefb377-c055-412c-a516-3940866d8911_bc5ebf2a-0fb7-4b67-8315-f3afc2b91ba9.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Lithium benzoate,553-54-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94958c81-74f1-4b60-a3e9-17bd91bdb13f/documents/6aefb377-c055-412c-a516-3940866d8911_bc5ebf2a-0fb7-4b67-8315-f3afc2b91ba9.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Lithium bis(oxalato)borate,244761-29-3," oral oral gavage, rat, OECD 408, GLP, NOAEL = 25 mg/kg bw/day (males) and 90 mg/kg bw/day (females) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/911cdc1b-3009-4e09-b94e-4fa7083a485a/documents/IUC5-b4bf6d26-5a53-47d6-8fd5-28668ce9dbfd_4f24d034-c7ec-4abb-99d6-6e5def48b63b.html,,,,,, Lithium bis(oxalato)borate,244761-29-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/911cdc1b-3009-4e09-b94e-4fa7083a485a/documents/IUC5-b4bf6d26-5a53-47d6-8fd5-28668ce9dbfd_4f24d034-c7ec-4abb-99d6-6e5def48b63b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Lithium bis(oxalato)borate,244761-29-3,"In the acute oral toxicity study (up-and-down procedure) of lithium bis(oxalato)borate a LD50 of 550 mg/kg bw could be derived.Under the experimental conditions adopted, the application of lithium bis(oxalato)borate for 24 h to the skin of male/female Wistar rats does not cause mortality up to a concentration of 2000 mg/kg bw.The acute inhalation LC50 was estimated to be more than (5220.8 ± 304.6) mg/m³ in both male and female rats. Based on the results, the test substance was classified as “practical non-toxic” by acute inhalation route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/911cdc1b-3009-4e09-b94e-4fa7083a485a/documents/IUC5-7e880ece-2ba6-4639-af41-272b3875e729_4f24d034-c7ec-4abb-99d6-6e5def48b63b.html,,,,,, Lithium bis(oxalato)borate,244761-29-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/911cdc1b-3009-4e09-b94e-4fa7083a485a/documents/IUC5-7e880ece-2ba6-4639-af41-272b3875e729_4f24d034-c7ec-4abb-99d6-6e5def48b63b.html,,oral,LD50,550 mg/kg bw,adverse effect observed, Lithium bis(oxalato)borate,244761-29-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/911cdc1b-3009-4e09-b94e-4fa7083a485a/documents/IUC5-7e880ece-2ba6-4639-af41-272b3875e729_4f24d034-c7ec-4abb-99d6-6e5def48b63b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Lithium bis(oxalato)borate,244761-29-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/911cdc1b-3009-4e09-b94e-4fa7083a485a/documents/IUC5-7e880ece-2ba6-4639-af41-272b3875e729_4f24d034-c7ec-4abb-99d6-6e5def48b63b.html,,inhalation,LC50,"5,220.8 mg/m3",no adverse effect observed, "Lithium bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",83949-60-4," Repeated dose toxicity: Oral Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for Lithium bis[2-[(4,5-dihydro-3-methyl-5-oxo- 1-phenyl-1H-pyrazol -4-yl) azo]benzoato(2-)]chromate(1-). The study assumed the use of male and female Wistar rats in a 28- 49 days toxicity study. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Level (NOAEL) for Lithium bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl) azo] benzoato(2-)]chromate(1-) is predicted to be 820.0 mg/Kg bw/day.   Based on this value it can be concluded that the substance is considered to be not toxic as per the criteria mentioned in CLP regulation. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6525b3d0-ad9a-4b26-a184-da8b3ba324ce/documents/4e40d308-9347-4021-b2c7-a943f601f663_8678ea07-2f7d-4110-a581-a0661998edfe.html,,,,,, "Lithium bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",83949-60-4,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6525b3d0-ad9a-4b26-a184-da8b3ba324ce/documents/4e40d308-9347-4021-b2c7-a943f601f663_8678ea07-2f7d-4110-a581-a0661998edfe.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,820 mg/kg bw/day,,rat "Lithium bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",83949-60-4," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target substance Lithium bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-) (83949-60-4) was estimated to be 5446.31 mg/kg bw,and for differentstudies available on the structurally similar read across substance 4,4'-(1E,1'E)-(3,3'-dichlorobiphenyl-4,4'-diyl)bis(diazene-2,1-diyl)bis(3-methyl-1-phenyl-1H-pyrazol-5(4H)-one) (3520-72-7) was considered to be >5000 mg/kg bw and for Disodium hydrogen bis[5-chloro-3-[(4,5-dihydro-3-methyl-5 -oxo-1-phenyl-1H -pyrazol-4- yl)azo]-2- hydroxybenzenesulphonato(3-)]chromate(3-) (6408-26-0) was considered to be >15000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Lithium bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-) (83949-60-4) cannot be classified for acute oral toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6525b3d0-ad9a-4b26-a184-da8b3ba324ce/documents/941534e5-7a57-4987-9777-adfd07782688_8678ea07-2f7d-4110-a581-a0661998edfe.html,,,,,, "Lithium bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",83949-60-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6525b3d0-ad9a-4b26-a184-da8b3ba324ce/documents/941534e5-7a57-4987-9777-adfd07782688_8678ea07-2f7d-4110-a581-a0661998edfe.html,,oral,LD50,"5,446.31 mg/kg bw",no adverse effect observed, Lithium bromide,7550-35-8," Based on human data  a NOAEL for long-term oral toxicity of 1.09 mg lithium bromide/kg bw/ day was calculated. Performance of repeated dermal and inhalation toxicity studies were waived. For CSA requirements NOAEL for long-term dermal toxicity and NOAEC for long-term inhalation toxicity were calculated based on the NOAEL long-term oral value. A NOAEL value of 10.9 mg/kg bw/day was calculated for long-term dermal toxicity and a NOAEC value of 3.8 mg/m³ was calculated for long-term inhalation toxicity (worker) as detailed in IUCLID section 7 ""Toxicological information"". ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d996b76-5226-4810-9fde-dd34909743e8/documents/568d2124-9eea-42a5-aaa6-9a2376f6ab97_019528c2-5511-4570-b074-43ebea083451.html,,,,,, Lithium bromide,7550-35-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d996b76-5226-4810-9fde-dd34909743e8/documents/568d2124-9eea-42a5-aaa6-9a2376f6ab97_019528c2-5511-4570-b074-43ebea083451.html,Chronic toxicity – systemic effects,oral,NOAEL,1.09 mg/kg bw/day,,other:human Lithium bromide,7550-35-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d996b76-5226-4810-9fde-dd34909743e8/documents/568d2124-9eea-42a5-aaa6-9a2376f6ab97_019528c2-5511-4570-b074-43ebea083451.html,Chronic toxicity – systemic effects,dermal,NOAEL,10.9 mg/kg bw/day,, Lithium bromide,7550-35-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d996b76-5226-4810-9fde-dd34909743e8/documents/568d2124-9eea-42a5-aaa6-9a2376f6ab97_019528c2-5511-4570-b074-43ebea083451.html,Chronic toxicity – systemic effects,inhalation,NOAEC,3.8 mg/m3,, Lithium bromide,7550-35-8," Based on the findings in the acute oral toxicity studies of lithium bromide, a LD50 range of greater than 500 to 1800 mg/kg bw/day could be derived. Under the conditions of the acute inhalation toxicity study, the four-hour LC50 for lithium bromide solution is greater than 15.57 mg/L (discriminating concentration). Based on the results in the acute dermal toxicity studies with lithium bromide, a LD50 greater than 2000 mg/kg (discriminating dose) in both male and female rats was derived. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d996b76-5226-4810-9fde-dd34909743e8/documents/343b319f-4d15-4ade-94fc-6e49ee34e03b_019528c2-5511-4570-b074-43ebea083451.html,,,,,, Lithium bromide,7550-35-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d996b76-5226-4810-9fde-dd34909743e8/documents/343b319f-4d15-4ade-94fc-6e49ee34e03b_019528c2-5511-4570-b074-43ebea083451.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Lithium bromide,7550-35-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d996b76-5226-4810-9fde-dd34909743e8/documents/343b319f-4d15-4ade-94fc-6e49ee34e03b_019528c2-5511-4570-b074-43ebea083451.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Lithium bromide,7550-35-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d996b76-5226-4810-9fde-dd34909743e8/documents/343b319f-4d15-4ade-94fc-6e49ee34e03b_019528c2-5511-4570-b074-43ebea083451.html,,inhalation,discriminating conc.,"15,570 mg/m3",no adverse effect observed, Lithium Citrate Tetrahydrate,6080-58-6," Read-across with lithium carbonate: LD50 (rat, oral): 525 mg/kg bw, corresponding to 1336 mg/kg bw for lithium citrate tetrahydrate Read-across with nitrate: LD50 (rat, oral): 1317 (male), 1519 (female) and 1426 (combined) mg/kg bw, corresponding to 1795 mg/kg (male), 2071 mg/kg (female), and 1944 mg/kg (combined) for lithium citrate tetrahydrate. Read-acorss with citric acid: LD50 (mice, oral): of 5400 mg/kg, corresponding to 7926 mg/kg bw for lithium citrate tetrahydrate. LD50 (rat, oral): Several LD50 values for citric acid in rat are reported in the OECD SIDS Initial Assessment Report. The LD50 values ranged from 3000 mg/kg to 12000 mg/kg bw, corresponding to LD50 values between 4403 and 17613 mg/kg bw for lithium citrate tetrahydrate. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa3edc5b-87f6-4341-952d-31ccf0c853ec/documents/636dbe9b-e1c6-4af4-a902-c4a892b26840_8b02b2ac-87f4-4e9c-9d06-298e472cac54.html,,,,,, Lithium Citrate Tetrahydrate,6080-58-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa3edc5b-87f6-4341-952d-31ccf0c853ec/documents/636dbe9b-e1c6-4af4-a902-c4a892b26840_8b02b2ac-87f4-4e9c-9d06-298e472cac54.html,,oral,LD50,"1,336 mg/kg bw",adverse effect observed, Lithium docosanoate,4499-91-6,"OECD 422 combined repeat dose and reproductive toxicity screening studies have been conducted on key substances which fall in the definition of the Lithium salts of monocarboxylic acids C14-C22 category. Studies were conducted via oral gavage on lithium myristate, fatty acids C16-18 lithium salts and fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. A study via dietary administration was conducted on lithium 12-hydroxystearate and a dermal study was conducted on fatty acids C18-(unsaturated) lithium salts. The NOAEL was >=500 mg/kg body weight/day for lithium myristate and fatty acids C16-18 lithium salts and was 250 mg/kg body weight/day for fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. The NOAEL for lithium 12-hydroxystearate was 2000 ppm (144 and 161 mg/kg body weight/day for males and females, respectively) based on parental body weights. The NOAEL for fatty acids C18-(unsaturated) lithium salts was 1089.75 mg/kg body weight/day based on systemic effects and 111.25 mg/kg body weight/day based on dermal scores. The results for the tested substances have been read across to the other members of the lithium salts of monocarboxylic acids C14-C22 category. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8de7adf-2ac8-4d7c-aafb-0281d084d46d/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_cab25af3-0edd-4029-b172-d7c06bceccf7.html,,,,,, Lithium docosanoate,4499-91-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8de7adf-2ac8-4d7c-aafb-0281d084d46d/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_cab25af3-0edd-4029-b172-d7c06bceccf7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,144 mg/kg bw/day,,rat Lithium docosanoate,4499-91-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8de7adf-2ac8-4d7c-aafb-0281d084d46d/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_cab25af3-0edd-4029-b172-d7c06bceccf7.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,089.75 mg/kg bw/day",,rat Lithium docosanoate,4499-91-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8de7adf-2ac8-4d7c-aafb-0281d084d46d/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_cab25af3-0edd-4029-b172-d7c06bceccf7.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.86 mg/cm2,adverse effect observed,rat Lithium docosanoate,4499-91-6,"Oral acute toxicity studies in rats were conducted on lithium myristate, fatty acids C18-(unsaturated) lithium salts, lithium docosanoate, and fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. All studies reported no mortality and LD50 values greater than 2000 mg/kg bodyweight. These data have been read across to the other substances in the lithium salts of monocarboxylic acids C14-C22 category. A dermal toxicity study in rats was conducted on fatty acids C18-(unsaturated) lithium salts. The study reported no mortality and LD50 values greater than 2000 mg/kg bodyweight. These data have been read across to the other substances in the lithium salts of monocarboxylic acids C14-C22 category. An estimate of the inhalation dust/mist toxicity by route-to-route extrapolation using conservative standard default values results in an ATE of 10.4 mg/L/4 hours minimum. This value is well above the cut values for classification for acute inhalation toxicity hazard. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8de7adf-2ac8-4d7c-aafb-0281d084d46d/documents/754e9131-4245-46c3-8876-e6b64b352e18_cab25af3-0edd-4029-b172-d7c06bceccf7.html,,,,,, Lithium docosanoate,4499-91-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8de7adf-2ac8-4d7c-aafb-0281d084d46d/documents/754e9131-4245-46c3-8876-e6b64b352e18_cab25af3-0edd-4029-b172-d7c06bceccf7.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Lithium docosanoate,4499-91-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8de7adf-2ac8-4d7c-aafb-0281d084d46d/documents/754e9131-4245-46c3-8876-e6b64b352e18_cab25af3-0edd-4029-b172-d7c06bceccf7.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Lithium fluoride,7789-24-4, Based on human data a NOAEL for long-term oral toxicity of 4.48 mg lithium fluoride/kg bw/day was calculated. Performance of repeated dermal and inhalation toxicity studies were waived.   ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/658db861-6032-44ac-85c7-3b112ad38896/documents/8cea4cbb-1ae0-4f43-89f6-8849672b8a64_65a49cca-22f0-48d4-bf86-921c1b07b9b8.html,,,,,, Lithium fluoride,7789-24-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/658db861-6032-44ac-85c7-3b112ad38896/documents/8cea4cbb-1ae0-4f43-89f6-8849672b8a64_65a49cca-22f0-48d4-bf86-921c1b07b9b8.html,Chronic toxicity – systemic effects,oral,NOAEL,4.48 mg/kg bw/day,,other:Weight of evidence approach in which the NOAEL value is derived from reliable human data. Lithium fluoride,7789-24-4, Based on the findings in an acute oral toxicity study an LD50 of 706 mg/kg bw was determined for male and female rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/658db861-6032-44ac-85c7-3b112ad38896/documents/9239f38d-bdab-4d2f-aadf-8025ff49daa8_65a49cca-22f0-48d4-bf86-921c1b07b9b8.html,,,,,, Lithium fluoride,7789-24-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/658db861-6032-44ac-85c7-3b112ad38896/documents/9239f38d-bdab-4d2f-aadf-8025ff49daa8_65a49cca-22f0-48d4-bf86-921c1b07b9b8.html,,oral,LD50,706 mg/kg bw,adverse effect observed, Lithium hexafluorophosphate(1-),21324-40-3,Skin corrosion is expected to occur on contact. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88f24f1c-5350-4fa7-9a60-163cb1a694c8/documents/fff30673-7b73-4808-964f-bfbc7e65e240_1e172e62-e95f-4e94-89bb-db20cfdb57cb.html,,,,,, Lithium hexafluorophosphate(1-),21324-40-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88f24f1c-5350-4fa7-9a60-163cb1a694c8/documents/fff30673-7b73-4808-964f-bfbc7e65e240_1e172e62-e95f-4e94-89bb-db20cfdb57cb.html,Chronic toxicity – systemic effects,oral,NOAEL,133 ,, Lithium hexafluorophosphate(1-),21324-40-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88f24f1c-5350-4fa7-9a60-163cb1a694c8/documents/fff30673-7b73-4808-964f-bfbc7e65e240_1e172e62-e95f-4e94-89bb-db20cfdb57cb.html,Chronic toxicity – systemic effects,inhalation,NOAEC,2 mg/m3,,other:man Lithium hexafluorophosphate(1-),21324-40-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88f24f1c-5350-4fa7-9a60-163cb1a694c8/documents/fff30673-7b73-4808-964f-bfbc7e65e240_1e172e62-e95f-4e94-89bb-db20cfdb57cb.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1.12 mg/m3,,other:man Lithium hexafluorophosphate(1-),21324-40-3,"In the rat acute oral toxicity study, a single 300 mg/kg dose proved lethal, and necropsy revealed damage to the stomach mucosa. No deaths followed dosing at 50 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88f24f1c-5350-4fa7-9a60-163cb1a694c8/documents/78e637f7-e262-40ab-86a4-f1389afed949_1e172e62-e95f-4e94-89bb-db20cfdb57cb.html,,,,,, Lithium hexafluorophosphate(1-),21324-40-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88f24f1c-5350-4fa7-9a60-163cb1a694c8/documents/78e637f7-e262-40ab-86a4-f1389afed949_1e172e62-e95f-4e94-89bb-db20cfdb57cb.html,,oral,LD50,200 mg/kg bw,adverse effect observed, Lithium isooctadecanoate,84731-55-5,"This is not a required endpoint at the tonnage band being registered (Annex VII) but the data were provided previously when the substance was registered at a higher tonnage band (Annex VIII), so have been kept in the dossier for consistency.   An OECD 422 combined repeat dose and reproductive and developmental toxicity screening study via dermal route has been read across from fatty acids C18-(unsaturated) lithium salts to lithium isooctadecanoate. See IUCLID section 13 for read across justification.    The study with fatty acids C18-(unsaturated) lithium salts showed no observable adverse systemic effect at the highest concentration tested (NOAEL: 1089.75 mg/kg bw/day) but showed dose responsive localised dermal effects at the test site (dorsal surface), consisting of scabbed post dose findings and elevated dermal scores. These were most pronounced and observed most frequently at the highest dose (1089.75 mg/kg bw/day), with lower incidence and lower dermal scores at 345 mg/kg bw/day and dermal scores and findings at 111.25 mg/kg bw/day were comparable to controls. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48b26387-baa1-4dfa-aa12-61f942ace342/documents/052cb2f6-3792-40a1-882b-eabb8b412f16_11996f62-1c4f-43eb-98f3-092962eb42b8.html,,,,,, Lithium isooctadecanoate,84731-55-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48b26387-baa1-4dfa-aa12-61f942ace342/documents/052cb2f6-3792-40a1-882b-eabb8b412f16_11996f62-1c4f-43eb-98f3-092962eb42b8.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,089.75 mg/kg bw/day",,rat Lithium isooctadecanoate,84731-55-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48b26387-baa1-4dfa-aa12-61f942ace342/documents/052cb2f6-3792-40a1-882b-eabb8b412f16_11996f62-1c4f-43eb-98f3-092962eb42b8.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.86 mg/cm2,adverse effect observed,rat Lithium isooctadecanoate,84731-55-5,"Lithium isooctadecanoate is concluded to be not acutely toxic via the oral route, with an LD50 of >2000 mg/kg bw. Although acute dermal toxicity is not a required endpoint at the tonnage band being registered (Annex VII), data were provided previously when the substance was registered at a higher tonnage band (Annex VIII), so have been kept in the dossier for consistency. Acute dermal toxicity data have been read across from fatty acids C18-(unsaturated) lithium salts. The LD50 was determined to be >2000 mg/kg bw. On this basis, it is considered that lithium isooctadecanoate would exhibit a lack of acute toxicity potential. There is no evidence of a relevant intrinsic acute toxicity requiring classification or substance specific RMMs. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48b26387-baa1-4dfa-aa12-61f942ace342/documents/5cb3a357-421d-45bb-8e34-4768056772fd_11996f62-1c4f-43eb-98f3-092962eb42b8.html,,,,,, Lithium isooctadecanoate,84731-55-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48b26387-baa1-4dfa-aa12-61f942ace342/documents/5cb3a357-421d-45bb-8e34-4768056772fd_11996f62-1c4f-43eb-98f3-092962eb42b8.html,,oral,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, Lithium isooctadecanoate,84731-55-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48b26387-baa1-4dfa-aa12-61f942ace342/documents/5cb3a357-421d-45bb-8e34-4768056772fd_11996f62-1c4f-43eb-98f3-092962eb42b8.html,,dermal,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, Lithium metaborate,13453-69-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52a47ae4-8e2f-4a27-bc57-58d165d5dc3e/documents/8ec0f271-b05a-48a5-8460-9535ea0fa70d_0afb23c2-c5df-480c-8f0c-5fb46ec6e68c.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Lithium neodecanoate,27253-30-1,"No repeated dose toxicity study with lithium neodecanoate is available, thus the repeated dose toxicity will be addressed with existing data on the individual moieties lithium and neodecanoate. In relevant and reliable oral repeated dose toxicity studies as well as supporting studies for the moiety neodecanoate, there were no toxicological findings reported. For the moiety lithium, a NOAEL for long-term oral toxicity of 6.43 mg lithium carbonate/kg bw/ day corresponding to 1.2 mg Li/kg bw/day was calculated based on human data obtained from long–term routine treatment of bipolar disorder with lithium carbonate. Based on experience with long-term application, e.g., lithium carbonate for therapy in humans, there is no evidence that lithium is of concern with respect to repeated oral toxicity at medical doses as the ones indicated above. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/110282a2-26f4-4d2a-82bd-e73078d33455/documents/309f32c6-c444-454b-9464-e399b8753e05_75de492f-9902-49b7-a6d7-fffc276b7c21.html,,,,,, Lithium neodecanoate,27253-30-1,"In a GLP conform OECD 423 study, the acute oral LD50 value of the test item lithium neodecanoate was found to be 300 < LD50 ≤ 2000 mg/kg bw in female Han:WIST rats.  These conclusions correspond with the results of acute oral LD50 data on the assessment entities lithium and neodecanoate. No acute dermal toxicity study with lithium neodecanoate is available, thus the acute dermal toxicity will be addressed with existing data on the dissociation products lithium and neodecanoic acid. Signs of acute dermal toxicity are not expected for lithium neodecanoate, since dermal absorption of the moiety lithium is low and the moiety neodecanoate have not shown signs of acute dermal toxicity in experimental testing (LD50 > 2000 mg/kg). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/110282a2-26f4-4d2a-82bd-e73078d33455/documents/6fcf554b-9f15-4de3-86c9-0bd5160b01c2_75de492f-9902-49b7-a6d7-fffc276b7c21.html,,,,,, Lithium neodecanoate,27253-30-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/110282a2-26f4-4d2a-82bd-e73078d33455/documents/6fcf554b-9f15-4de3-86c9-0bd5160b01c2_75de492f-9902-49b7-a6d7-fffc276b7c21.html,,oral,LD50,ca.500 mg/kg bw,adverse effect observed, Lithium Nickel Cobalt Aluminium Oxide,177997-13-6,The “No Observed Adverse Effect Level” (NOAEL) for oral systemic toxicity for males was considered to be 50 mg/kg/day and the “No Observed Effect Level” (NOEL) for oral systemic toxicity for females was considered to be 50 mg/kg/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/376ae0e5-5e86-45b2-b5db-e1f8a8e42e8a/documents/IUC5-b37bf850-a0e8-4d48-a9a8-5e20c152ab09_8559f9dd-0938-4d1d-a063-04f5e38951d5.html,,,,,, Lithium Nickel Cobalt Aluminium Oxide,177997-13-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/376ae0e5-5e86-45b2-b5db-e1f8a8e42e8a/documents/IUC5-b37bf850-a0e8-4d48-a9a8-5e20c152ab09_8559f9dd-0938-4d1d-a063-04f5e38951d5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Lithium Nickel Cobalt Aluminium Oxide,177997-13-6," The acute oral median lethal dose (LD50) of the test material in the female Sprague Dawley CD strain rat (Sanders, 2008)was estimated to be greater than 2000 mg/kg bodyweight, resulting in a no-classification for this endpoint. The theoretically derived classification with MeClas resulted in a more stringent Cat.4 classification wor the worst-case composition, and this classification was determined by the presence of CoO (Co: 12%). The test that was conducted by Sanders (2008) used an NCA-sample that had a Co-concentration (11.2%) that was similar to that of the worst-case composition, and that was markedly higher than the typical Co-concentration of NCA (5.15%) An acute inhalation study was performed by Toda (2014), using male/female Wistar rats. No mortality was observed at 0.05 mg/L (upper threshold value for Cat.1 -classification), but 90% mortality was observed at a concentration of 0.23 mg/L. A Cat.2 classification is allocated for substances with an LC50 between 0.05 and 0.5 mg/L.   The theoretically derived classification with MeClas confirmed this classification. No adverse effects were observed in a dermal toxicity test with male/female Wistar rats, resulting in a no-classification for this endpoint. The theoretically derived classification with MeClas confirmed this no-classification. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/376ae0e5-5e86-45b2-b5db-e1f8a8e42e8a/documents/bbea411a-8200-407d-989e-1cba1875423d_8559f9dd-0938-4d1d-a063-04f5e38951d5.html,,,,,, lithium nickel dioxide,12031-65-1,"LD50, oral, rat > 2000 mg/kg bw (OECD 423, BASF SE, 2021) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP guideline study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1a30672-366c-40cf-9a93-c160f8efa641/documents/d6f3c6da-4f66-408e-aca8-6622bd666f84_7f8b91a4-7d43-4bc8-97e9-d4f68c91d5ff.html,,,,,, lithium nickel dioxide,12031-65-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1a30672-366c-40cf-9a93-c160f8efa641/documents/d6f3c6da-4f66-408e-aca8-6622bd666f84_7f8b91a4-7d43-4bc8-97e9-d4f68c91d5ff.html,,oral,LD0,">=2,000 mg/kg bw",no adverse effect observed, Lithium nickel potassium oxide,210352-95-7,"Repeat Dose Oral: CONCLUSIONSIn conclusion, the test substance, lithium nickel potassium oxide (KDLNO), did not show anyadverse effects on neurobehavior, thyroid hormone or thyroid gland, reproductive performance,or postnatal development. Mortality and moribundity caused by injury to the gastrointestinaltract (males and females) and lungs (high dose females), adverse clinical observations, lowerbody weights, and food consumption were noted for females at 30, 100, and 200 mg/kg/day andfor males at 200 mg/kg/day. Lower spleen, thymus, and prostate weights and microscopicfindings in the spleen and lung were noted for males at 200 mg/kg/day. Under the conditions ofthis screening study, the no-observed-adverse-effect level (NOAEL) for F0 male systemictoxicity was determined to be 100 mg/kg/day when the test substance was administered by oralgavage to Crl:CD(SD) rats. Based on the results, a NOAEL for F0 female systemic toxicity couldnot be determined. There were no effects on reproductive parameters for F0 males, and thereforea dosage level of 200 mg/kg/day was considered to be the NOAEL for F0 male reproductivetoxicity. Based on the secondary dystocia and longer gestation lengths at 30, 100, and200 mg/kg/day, a NOAEL for F0 female reproductive toxicity was not determined. The NOAELfor F1 neonatal toxicity was 100 mg/kg/day based on the absence of any adverse effects onpostnatal development at this dosage level.   Repeat Dose Inhalation: In conclusion, administration of lithium nickel potassium oxide (KDLNO) by nose-onlyinhalation to Crl:CD(SD) rats at exposure concentrations of 0.10, 0.25, 0.50, and 1.0 mg/m3 for6 hours/day on a 5-day per week basis for 4 weeks (minimum of 20 exposures for each animal)resulted in higher lung weights and increased alveolar macrophages, mixed cell inflammation,and/or cellular debris in the 0.10 mg/m3 group at the primary and/or recovery necropsies. Basedon these findings, the adaptive response of increased macrophages to inhaled particle wasexceeded and therefore was considered adverse. Based on these results, a lowest-observed adverse - effect-concentration (LOAEC) was considered to be 0.10 mg/m3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ff4327c-9bf6-4112-aa29-8761b65bb27f/documents/233c0517-143e-4a95-a879-360ba00c3db8_fe58f62b-429f-4592-8c3f-d5f5dbd936b3.html,,,,,, Lithium nickel potassium oxide,210352-95-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ff4327c-9bf6-4112-aa29-8761b65bb27f/documents/233c0517-143e-4a95-a879-360ba00c3db8_fe58f62b-429f-4592-8c3f-d5f5dbd936b3.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,30 mg/kg bw/day,,rat Lithium nickel potassium oxide,210352-95-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ff4327c-9bf6-4112-aa29-8761b65bb27f/documents/233c0517-143e-4a95-a879-360ba00c3db8_fe58f62b-429f-4592-8c3f-d5f5dbd936b3.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,0.1 mg/m3,,rat Lithium nickel potassium oxide,210352-95-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ff4327c-9bf6-4112-aa29-8761b65bb27f/documents/233c0517-143e-4a95-a879-360ba00c3db8_fe58f62b-429f-4592-8c3f-d5f5dbd936b3.html,Repeated dose toxicity – local effects,inhalation,LOAEC,0.1 mg/m3,adverse effect observed,rat Lithium nickel potassium oxide,210352-95-7,"Acute Oral Toxicity; Under the conditions of this study the median lethal dose of KDLNO after oral administration was found to be greater than 500 mg/kg bw and less than 2000 mg/kg bw in rats.   Acute Inhalation Toxicity: Under the current study conditions, the LC50 value for female Wistar rats was 2.048 mg/L (calculated based on analytical concentration) after a 4-hour inhalation exposure to the dust aerosol of KDLNO. The LC50 value for male Wistar rats is considered to be > 2.037 mg/L (based on analytical concentration) after a 4-hour inhalation exposure to the dust aerosol of KDLNO.   Acute Dermal Toxicity: The acute dermal median lethal dose (LD50) was determined to be LD50, dermal, rat > 2000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): LC50 value chosen for females as a worst case. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ff4327c-9bf6-4112-aa29-8761b65bb27f/documents/d3ea5454-a58f-40d9-ab36-52a687bb9dfe_fe58f62b-429f-4592-8c3f-d5f5dbd936b3.html,,,,,, Lithium nickel potassium oxide,210352-95-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ff4327c-9bf6-4112-aa29-8761b65bb27f/documents/d3ea5454-a58f-40d9-ab36-52a687bb9dfe_fe58f62b-429f-4592-8c3f-d5f5dbd936b3.html,,oral,LD50,> 500 mg/kg bw,adverse effect observed, Lithium nickel potassium oxide,210352-95-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ff4327c-9bf6-4112-aa29-8761b65bb27f/documents/d3ea5454-a58f-40d9-ab36-52a687bb9dfe_fe58f62b-429f-4592-8c3f-d5f5dbd936b3.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Lithium nickel potassium oxide,210352-95-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ff4327c-9bf6-4112-aa29-8761b65bb27f/documents/d3ea5454-a58f-40d9-ab36-52a687bb9dfe_fe58f62b-429f-4592-8c3f-d5f5dbd936b3.html,,inhalation,LC50,2.048 mg/L,adverse effect observed, Lithium nitrate,7790-69-4, Based on human data a NOAEL for long-term oral toxicity of 4.11 mg lithium nitrate/kg bw/day was calculated. Performance of repeated dermal and inhalation toxicity studies were waived. For CSA requirements NOAEL for long-term dermal toxicity and NOAEC for long-term inhalation toxicity were calculated based on the NOAEL long-term oral value. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fad01559-1e70-4c2f-8cae-fc156da56bdc/documents/cff297f9-2951-48cd-bfe8-9a636aaff17c_cb4164c6-d96f-4967-8f7e-2bab5a3baa2f.html,,,,,, Lithium nitrate,7790-69-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fad01559-1e70-4c2f-8cae-fc156da56bdc/documents/cff297f9-2951-48cd-bfe8-9a636aaff17c_cb4164c6-d96f-4967-8f7e-2bab5a3baa2f.html,Chronic toxicity – systemic effects,oral,NOAEL,4.11 mg/kg bw/day,,other:human Lithium nitrate,7790-69-4," Based on the results of the acute oral toxicity study of lithium nitrate a LD50 of 1317 (male), 1519 (female) and 1426 (Combined) mg/kg bw was derived. Under the conditions of the acute inhalation study, the 4-h LC50 for lithium nitrate solution is greater than 5.93 mg/L (discriminating concentration). Based on the findings in the acute dermal toxicity study, a single dermal administration of lithium nitrate in water did not induce any test item related adverse effects and a LD50 of >2000 mg/kg bw  (discriminating dose) could be derived. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fad01559-1e70-4c2f-8cae-fc156da56bdc/documents/22e048d7-d020-495c-a851-a93118d1b996_cb4164c6-d96f-4967-8f7e-2bab5a3baa2f.html,,,,,, Lithium nitrate,7790-69-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fad01559-1e70-4c2f-8cae-fc156da56bdc/documents/22e048d7-d020-495c-a851-a93118d1b996_cb4164c6-d96f-4967-8f7e-2bab5a3baa2f.html,,oral,LD50,"1,426 mg/kg bw",adverse effect observed, Lithium nitrate,7790-69-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fad01559-1e70-4c2f-8cae-fc156da56bdc/documents/22e048d7-d020-495c-a851-a93118d1b996_cb4164c6-d96f-4967-8f7e-2bab5a3baa2f.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Lithium nitrate,7790-69-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fad01559-1e70-4c2f-8cae-fc156da56bdc/documents/22e048d7-d020-495c-a851-a93118d1b996_cb4164c6-d96f-4967-8f7e-2bab5a3baa2f.html,,inhalation,discriminating conc.,"5,930 mg/m3",no adverse effect observed, Lithium phosphorodifluoridate,24389-25-1," In an GLP-compliant study conducted in accordance with a standard method equivalent to the OECD guideline, the repeated dose toxicity to rats via the oral route was assessed over a 28-day period. Mortality and treatment-related effects were observed in the stomach and kidney in the highest dose tested (40 mg/kg/day) in both male and female rats. Treatment-related effects were also observed in the stomach at the middle dose treated (8 mg/kg/day) in males although minimal and considered not adverse. For the purpose of the Chemical Safety Assessment, the lowest NOAEL determined from this study (8 mg/kg/day - males/females) was conservatively selected. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06bc4d98-7145-4c92-a49e-6106171b8ee3/documents/d3c5b363-7817-4b45-b0bb-b60a2db0d2fb_e04962e7-a3af-4c4b-be58-9cd0880dd853.html,,,,,, Lithium phosphorodifluoridate,24389-25-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06bc4d98-7145-4c92-a49e-6106171b8ee3/documents/d3c5b363-7817-4b45-b0bb-b60a2db0d2fb_e04962e7-a3af-4c4b-be58-9cd0880dd853.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,8 mg/kg bw/day,,rat Lithium phosphorodifluoridate,24389-25-1," Acute toxicity of the test item to rats was determined in two studies using different exposure routes (oral and dermal). Both studies were conducted in accordance with the relevant OECD guideline and to GLP. Mortality was observed in studies and severe corrosive effects were noted in the dermal study at 1000 mg/kg and 2000 mg/kg. The LD50 value ranges were determined as 1000 - 2000 mg/kg for the acute dermal study and 50 - 300 mg/kg for the acute oral study. For the purpose of the Chemical Safety Assessment, LD50 cut-off values published in the OECD guidelines 423 - oral, were used. The LD50 cut-off value is stated as 200 mg/kg (oral) for the testing schedule conducted in the study. Although, there was no mortality in the 1000 mg/kg group to assess acute dermal toxicity there was severe corrosive effects therefore the LD50 value is conservatively set at 1000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06bc4d98-7145-4c92-a49e-6106171b8ee3/documents/1f82ccaf-2aae-427f-9705-6f9fff683b80_e04962e7-a3af-4c4b-be58-9cd0880dd853.html,,,,,, Lithium phosphorodifluoridate,24389-25-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06bc4d98-7145-4c92-a49e-6106171b8ee3/documents/1f82ccaf-2aae-427f-9705-6f9fff683b80_e04962e7-a3af-4c4b-be58-9cd0880dd853.html,,oral,LD50,200 mg/kg bw,adverse effect observed, Lithium ricinoleate,15467-06-8," Conformément à la section 2 de l'annexe VII du règlement 1907/2006 / CE de REACH 1907/2006 / CE et conformément au bien-être animal, une étude de toxicité aiguë par voie orale n'est pas nécessaire car le lithium est classé comme corrosif pour la peau CE) N ° 1272/2008 CLP (Cat 1B, H314) et selon la Directive 67/548 / CEE (R34). De plus, l'exécution d'une étude orale aiguë peut être waivée dans le cadre de REACH (Annexe XI) car l'exposition peut être exclue en raison de la RMM appliquée en raison des propriétés de la substance (corrosive, inflammable au contact de l'eau). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c7fcb83-cb1a-4a95-8a16-e2b4e5770fc9/documents/ae47be91-6e56-4f91-8e88-f547f6ea0a22_8d6fc028-64ef-4375-b8bc-7272351d828d.html,,,,,, Lithium sulphate,10377-48-7," Based on human data obtained from long–term routine treatment of bipolar disorder with lithium (administered as lithium carbonate), NOAEL values for long-term oral toxicity of 9.5 mg Li2SO4/kg bw/ day and 11.06 mg Li2SO4*H2O/kg bw/day was calculated. Performance of repeated dermal and inhalation toxicity studies were waived. For CSA requirements NOAEL for long-term dermal toxicity and NOAEC for long-term inhalation toxicity were calculated based on the NOAEL value used for long-term oral toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98ad9395-deb7-4483-b172-54acd32651ce/documents/d018be02-22d0-48f1-a092-051cbf9988a9_7199876a-0485-456c-8f7a-d0e94d40048e.html,,,,,, Lithium sulphate,10377-48-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98ad9395-deb7-4483-b172-54acd32651ce/documents/d018be02-22d0-48f1-a092-051cbf9988a9_7199876a-0485-456c-8f7a-d0e94d40048e.html,Chronic toxicity – systemic effects,oral,NOAEL,9.5 mg/kg bw/day,,other:human Lithium sulphate,10377-48-7,Three weight of evidence approaches were obtained from handbook and/or published data regarding the acute oral toxicity of lithium sulfate. The LD50 (oral route) values are within the range of 300 and 2000 mg/kg bw.In the acute dermal toxicity study conducted with lithium carbonate an LD50 value of above 3000 mg/kg bw was determined. Based on a read-across approach the LD50 for lithium sulfate and its monohydrate can be assumed to be above 3000 mg/kg bw.The acute inhalation toxicity study a LC50 of greater than 2 mg/L was determined when exposing Sprague Dawley rats to a single dose of lithium carbonate. Based on the read-across approach the LC50 for lithium sulfate and its monohydrate is greater than 2 mg/L. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98ad9395-deb7-4483-b172-54acd32651ce/documents/4f6a0f17-dcbc-4eb9-b3ba-6679e4eaf052_7199876a-0485-456c-8f7a-d0e94d40048e.html,,,,,, Lithium sulphate,10377-48-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98ad9395-deb7-4483-b172-54acd32651ce/documents/4f6a0f17-dcbc-4eb9-b3ba-6679e4eaf052_7199876a-0485-456c-8f7a-d0e94d40048e.html,,oral,LD50,613 mg/kg bw,adverse effect observed, Lithium sulphate,10377-48-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98ad9395-deb7-4483-b172-54acd32651ce/documents/4f6a0f17-dcbc-4eb9-b3ba-6679e4eaf052_7199876a-0485-456c-8f7a-d0e94d40048e.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, Lithium sulphate,10377-48-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98ad9395-deb7-4483-b172-54acd32651ce/documents/4f6a0f17-dcbc-4eb9-b3ba-6679e4eaf052_7199876a-0485-456c-8f7a-d0e94d40048e.html,,inhalation,LC50,"2,000 mg/m3",no adverse effect observed, Tetralithium pentatitanium dodecaoxide,12031-95-7,"As was expected from the insoluble test substance, no adverse effects were detected in a repeated dose toxicity study. The NOAEL is 1000 mg/kg bw/d. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ac5dff7-de56-4216-90a7-98e080de7948/documents/IUC5-cb5b9f20-0ace-4871-90fa-a3c174af3027_9a443aa9-016e-41b7-a1c2-57a6e9670d6c.html,,,,,, Tetralithium pentatitanium dodecaoxide,12031-95-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ac5dff7-de56-4216-90a7-98e080de7948/documents/IUC5-cb5b9f20-0ace-4871-90fa-a3c174af3027_9a443aa9-016e-41b7-a1c2-57a6e9670d6c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tetralithium pentatitanium dodecaoxide,12031-95-7,Lithium titanium oxide is of low acute toxicity. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ac5dff7-de56-4216-90a7-98e080de7948/documents/IUC5-27407850-3277-4ffe-839d-c000e2bc2618_9a443aa9-016e-41b7-a1c2-57a6e9670d6c.html,,,,,, Tetralithium pentatitanium dodecaoxide,12031-95-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ac5dff7-de56-4216-90a7-98e080de7948/documents/IUC5-27407850-3277-4ffe-839d-c000e2bc2618_9a443aa9-016e-41b7-a1c2-57a6e9670d6c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetralithium pentatitanium dodecaoxide,12031-95-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ac5dff7-de56-4216-90a7-98e080de7948/documents/IUC5-27407850-3277-4ffe-839d-c000e2bc2618_9a443aa9-016e-41b7-a1c2-57a6e9670d6c.html,,inhalation,LC50,"5,040 mg/m3",no adverse effect observed, L-menthyl acetate,2623-23-6,Read-across compound DL-menthol is not toxic in rats when applied daily by oral route (feed) at a dose of 375 mg/kg bw/day for 103 weeks (corresponding to a NOEL for L-menthyl acetate of 476 mg/kg bw/day). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88f7b81e-8a5a-4c3a-8cbe-53e599911438/documents/f0f8e7c5-24a3-4513-8b28-68e1fb3ff0a4_893ca1d8-e7a2-41d4-a934-8f0de128bbe7.html,,,,,, L-menthyl acetate,2623-23-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88f7b81e-8a5a-4c3a-8cbe-53e599911438/documents/f0f8e7c5-24a3-4513-8b28-68e1fb3ff0a4_893ca1d8-e7a2-41d4-a934-8f0de128bbe7.html,Chronic toxicity – systemic effects,oral,NOAEL,476 mg/kg bw/day,,rat L-menthyl acetate,2623-23-6, No studies are available for L-menthyl acetate. Reliable data are available with the structural analogue menthyl acetate (CAS 89 -48 -5). Oral (RA CAS 89 -48 -5): LD50 > 5000 mg/kg body weight leading to non-classification according to CLP Dermal (RA CAS 89 -48 -5): LD50 > 5000 mg/kg body weight leading to non-classification according to CLP Inhalation: no information available ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88f7b81e-8a5a-4c3a-8cbe-53e599911438/documents/e79f41e0-9bd0-4cf8-9416-a1bc0b4efc25_893ca1d8-e7a2-41d4-a934-8f0de128bbe7.html,,,,,, L-menthyl acetate,2623-23-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88f7b81e-8a5a-4c3a-8cbe-53e599911438/documents/e79f41e0-9bd0-4cf8-9416-a1bc0b4efc25_893ca1d8-e7a2-41d4-a934-8f0de128bbe7.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, L-menthyl acetate,2623-23-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88f7b81e-8a5a-4c3a-8cbe-53e599911438/documents/e79f41e0-9bd0-4cf8-9416-a1bc0b4efc25_893ca1d8-e7a2-41d4-a934-8f0de128bbe7.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Lofepramine,23047-25-8," Two acute toxicity values are available, as secondary source, for Lofepramine: mouse, LD50, oral > 2500 mg/kg rat, LD50, oral > 1000 mg/kg Since in one case the LD50 is major than 2000 mg/kg it can be concluded that the substance is not classified as Acute Oral Toxicity. Two acute subcutaneous toxicity values are available, as secondary source, for Lofepramine: mouse, LD50, sc > 1000 mg/kg rat, LD50, sc >1000 mg/kg In this case data are inconclusive regarding classification. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a17d4ac-0f2d-4b87-8af4-6587cde7f7bc/documents/fe6be5d6-5fc2-4b9f-9213-3ddb052437e4_eb7d17a4-034b-4fb1-9040-61de5cfbc787.html,,,,,, Lofepramine,23047-25-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a17d4ac-0f2d-4b87-8af4-6587cde7f7bc/documents/fe6be5d6-5fc2-4b9f-9213-3ddb052437e4_eb7d17a4-034b-4fb1-9040-61de5cfbc787.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Lofepramine,23047-25-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a17d4ac-0f2d-4b87-8af4-6587cde7f7bc/documents/fe6be5d6-5fc2-4b9f-9213-3ddb052437e4_eb7d17a4-034b-4fb1-9040-61de5cfbc787.html,,dermal,LD50,"1,000 mg/kg bw",no adverse effect observed, (4S)-4-cyclohexyl-L-proline,103201-78-1,"In the acute toxicity study by oral route, no deaths were observed in 6 animals (both males and females) given 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f16ff8cf-99b4-40c2-ab28-29eda0c7fd9d/documents/IUC5-8abde0d4-dbf3-474b-a654-d21b70eb5846_19d9d91e-d877-4b7f-8ac4-8b10753b1f3c.html,,,,,, 6-deoxy-6-formamido-L-sorbose,115241-16-2,"No repeated dose toxicity studies are available for N-Formylaminosorbose. However, there is a repeated dose toxicity study for the structural analogue N-Formylaminosorbit (CAS 89182-60-5):Oral, subacute 4 weeks (Rat-Wistar, GLP, OECD TG 407): NOAEL = 1000 mg/kg[Bayer AG, Report No. PH-34477, 2006-05-31] ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/886130a2-1134-4bc8-b5bf-7cfaa2329788/documents/IUC5-5ca705b5-500f-418e-b4bc-35c182a02191_6b00d26c-18ac-4861-8f1f-7b91ec54f3ed.html,,,,,, 6-deoxy-6-formamido-L-sorbose,115241-16-2,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/886130a2-1134-4bc8-b5bf-7cfaa2329788/documents/IUC5-5ca705b5-500f-418e-b4bc-35c182a02191_6b00d26c-18ac-4861-8f1f-7b91ec54f3ed.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 6-deoxy-6-formamido-L-sorbose,115241-16-2,"No acute toxicity studies are available for N-Formylaminosorbose. However, there are acute toxicity studies for the structural analogue N-Formylaminosorbit (CAS 89182-60-5):Oral (Rat-Wistar, GLP, OECD TG 401): LD50 > 2000 mg/kg[Bayer AG, Report No. PH-18819, 1990-02-20]Inhalation (Rat-Wistar, GLP, OECD TG 403, EU Method B.2, OPPTS 870.1300): LC50 > 4575 mg/m³[Bayer AG, Report No. PH-34479, 2006-06-01] ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/886130a2-1134-4bc8-b5bf-7cfaa2329788/documents/IUC5-6a8912f1-07b7-44fe-956a-db68a0289ed8_6b00d26c-18ac-4861-8f1f-7b91ec54f3ed.html,,,,,, "L-Tyrosine, 3,5-dinitro-",17360-11-1, A study on acute oral toxicity according to OECD 423 was conducted. The LD50 was found to be > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83d81a19-e548-4657-a092-16b62c62c3be/documents/ee51f38b-34a4-4af4-a40c-8e5dc2a24a1b_a02d1b24-34a5-4b04-8aa1-0b53f1abbe77.html,,,,,, "L-Tyrosine, 3,5-dinitro-",17360-11-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83d81a19-e548-4657-a092-16b62c62c3be/documents/ee51f38b-34a4-4af4-a40c-8e5dc2a24a1b_a02d1b24-34a5-4b04-8aa1-0b53f1abbe77.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "L-Tyrosine, N-acetyl-3,5-diiodo-O-(4-methoxyphenyl)-, ethyl ester",83249-56-3, A study on acute oral toxicity according to OECD 423 was conducted. The LD50 was found to be > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97daf7bc-f1ee-4290-aef8-6cdbff21c8f9/documents/224bd08f-d6ec-4356-a3cb-92d0674751c6_88999e32-7e0c-4ce9-b2b0-b9c3983a32a2.html,,,,,, "L-Tyrosine, N-acetyl-3,5-diiodo-O-(4-methoxyphenyl)-, ethyl ester",83249-56-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97daf7bc-f1ee-4290-aef8-6cdbff21c8f9/documents/224bd08f-d6ec-4356-a3cb-92d0674751c6_88999e32-7e0c-4ce9-b2b0-b9c3983a32a2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "L-Tyrosine, N-acetyl-3,5-dinitro-",20767-00-4, A study on acute oral toxicity according to OECD 423 was conducted. The LD50 was found to be > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6cf9a2e5-bd26-4e7b-8d05-a16b054920cc/documents/b1ddc593-48b6-4b56-b48f-74c4f2dad2fb_42061c8d-67fb-4d37-98e5-0d1a37b04fea.html,,,,,, "L-Tyrosine, N-acetyl-3,5-dinitro-",20767-00-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6cf9a2e5-bd26-4e7b-8d05-a16b054920cc/documents/b1ddc593-48b6-4b56-b48f-74c4f2dad2fb_42061c8d-67fb-4d37-98e5-0d1a37b04fea.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "L-Tyrosine, N-acetyl-O-(4-methoxyphenyl)-3,5-dinitro-, ethyl ester",83290-90-8, A study on acute oral toxicity according to OECD 423 was conducted. The LD50 was found to be > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa8d2a4b-21f0-4f23-b513-2f09d1d1be6e/documents/fb2b1384-b4e5-4587-b68a-045270fcd13f_b4376eb9-7210-4a34-a005-b0863d285dee.html,,,,,, "L-Tyrosine, N-acetyl-O-(4-methoxyphenyl)-3,5-dinitro-, ethyl ester",83290-90-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa8d2a4b-21f0-4f23-b513-2f09d1d1be6e/documents/fb2b1384-b4e5-4587-b68a-045270fcd13f_b4376eb9-7210-4a34-a005-b0863d285dee.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, (2S)-2-amino-3-(4-{[bis(sodiooxy)phosphoryl]oxy}phenyl)propanoic acid,1610350-91-8," In an acute oral feeding study in rats according to OECD guideline 420, the acute median lethal oral dose (LD50) of the test item was demonstrated to be greater than 2000 mg/kg body weight (reference 7.2.1 -1). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/897780cf-d216-4b61-bad7-b20b97fcb8df/documents/25da3aa9-09b9-4e1c-8858-e5f7c2f0d659_14ded6c9-7f55-411a-a7a1-b7a2d12fa942.html,,,,,, (2S)-2-amino-3-(4-{[bis(sodiooxy)phosphoryl]oxy}phenyl)propanoic acid,1610350-91-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/897780cf-d216-4b61-bad7-b20b97fcb8df/documents/25da3aa9-09b9-4e1c-8858-e5f7c2f0d659_14ded6c9-7f55-411a-a7a1-b7a2d12fa942.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Lubricating oils, used",70514-12-4,"Based on 28-day studies, the rabbit dermal repeat-dose NOAEL is 1000 mg/kg, the rat inhalation repeat-dose NOAEL (local effects) is > 220 mg/m3, and systemic effects are seen at doses > 980 mg/m3.  The 90-day dermal studies gave a NOAEL of greater than 2000 mg/kg for sufficiently refined other lubricant base oils.  Sufficiently refined other lubricant base oils are not classified according to DSD for repeat-dose toxicity. Insufficiently refined other lubricant base oils are classified as carcinogenic. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0f9610c-9ae6-4354-af7f-d0b2a39bb53c/documents/7d88ca85-4ca0-47b9-8b2b-c1e8e0ef9aeb_f5407cdf-2f3b-4816-93e7-2e353c10aaef.html,,,,,, "Lubricating oils, used",70514-12-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0f9610c-9ae6-4354-af7f-d0b2a39bb53c/documents/7d88ca85-4ca0-47b9-8b2b-c1e8e0ef9aeb_f5407cdf-2f3b-4816-93e7-2e353c10aaef.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Lubricating oils, used",70514-12-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0f9610c-9ae6-4354-af7f-d0b2a39bb53c/documents/7d88ca85-4ca0-47b9-8b2b-c1e8e0ef9aeb_f5407cdf-2f3b-4816-93e7-2e353c10aaef.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rabbit "Lubricating oils, used",70514-12-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0f9610c-9ae6-4354-af7f-d0b2a39bb53c/documents/7d88ca85-4ca0-47b9-8b2b-c1e8e0ef9aeb_f5407cdf-2f3b-4816-93e7-2e353c10aaef.html,Chronic toxicity – systemic effects,inhalation,NOAEC,5 mg/m3,,rabbit "Lubricating oils, used",70514-12-4,"Acute Oral Toxicity:Acute oral toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3%) in male and female rats was evaluated in API, 1982a by a single oral gavage administration of 5000 mg/kg body weight. The studies adhered to OECD Guideline 401, which is equivalent or similar to OECD Guideline 420. Based on the lack of clinical signs of toxicity or mortality, the acute oral LD50 for other lubricant base oils ""sufficiently refined"" and ""insufficiently refined"" is >5000 mg/kg.Acute Dermal Toxicity:Acute dermal toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3%) in male and female rabbits was evaluated in a key Study by API, 1982a. At doses of either 2000 or 5000 mg/kg body weight. Based on the lack of adverse systemic effects or mortality, the acute dermal LD50 for other lubricant base oils ""sufficiently refined"" is >5000 mg/kg.Acute Inhalation Toxicity:Acute inhalation toxicity of various paraffinic and naphthenic other lubricant base oils (IP 346 < 3%) in male and female rats was evaluated in a key study by Exxon Biomedical Sciences, Inc, 1988a. An aerosol concentration of 5mg/L was found to have no effect. Additional supporting studies also evaluated the acute inhalation toxicity of greater and less than 3% OLBOs. The acute inhalation LC50 for other lubricant base oils is >5.0 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0f9610c-9ae6-4354-af7f-d0b2a39bb53c/documents/77dd926e-1e58-4834-bd09-112c9b07dba0_f5407cdf-2f3b-4816-93e7-2e353c10aaef.html,,,,,, "Lubricating oils, used",70514-12-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0f9610c-9ae6-4354-af7f-d0b2a39bb53c/documents/77dd926e-1e58-4834-bd09-112c9b07dba0_f5407cdf-2f3b-4816-93e7-2e353c10aaef.html,,oral,LD50,"5,000 mg/kg bw",, "Lubricating oils, used",70514-12-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0f9610c-9ae6-4354-af7f-d0b2a39bb53c/documents/77dd926e-1e58-4834-bd09-112c9b07dba0_f5407cdf-2f3b-4816-93e7-2e353c10aaef.html,,dermal,LD50,"5,000 mg/kg bw",, "Lubricating oils, used",70514-12-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0f9610c-9ae6-4354-af7f-d0b2a39bb53c/documents/77dd926e-1e58-4834-bd09-112c9b07dba0_f5407cdf-2f3b-4816-93e7-2e353c10aaef.html,,inhalation,LC50,5 mg/m3,, "Lubricating oils, used, distd.",92045-40-4,An acute oral toxicity study has been carried out on the substance according to OECD Guideline 420. The acute oral median lethal dose (LD50) of the substance in rats is >2000 mg/kg bw/d. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fad2e70-3c83-453b-acb2-f753f5b30665/documents/IUC5-787197a0-d90f-4035-b5a6-1a19c9ea3b56_152b5e9f-2a20-40a1-bae7-af6c43219c18.html,,,,,, "Lubricating oils, used, distd.",92045-40-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fad2e70-3c83-453b-acb2-f753f5b30665/documents/IUC5-787197a0-d90f-4035-b5a6-1a19c9ea3b56_152b5e9f-2a20-40a1-bae7-af6c43219c18.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Lubricating oils, used, vacuum distd.",92045-41-5,"Data from the category were not used to assess this endpoint for the substance of interest, due to the unusual method and test conditions used in the study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5a58d75-0f34-412f-8d41-1bbe6afb9015/documents/IUC5-0489c88e-56d7-4407-861a-232922044397_49132548-180d-466f-aee4-de33a1167b28.html,,,,,, "Lubricating oils, used, vacuum distd.",92045-41-5,"Based on experimental study performed in accordance with OECD 420, the oral LD50 for the substance is > 2000 mg/kg. Based on read across approach, dermal acute toxicity studies show that dermal LD50 is > 2000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5a58d75-0f34-412f-8d41-1bbe6afb9015/documents/IUC5-b372252f-eead-4ed3-911c-74c27ca89a9d_49132548-180d-466f-aee4-de33a1167b28.html,,,,,, "Lubricating oils, used, vacuum distd.",92045-41-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5a58d75-0f34-412f-8d41-1bbe6afb9015/documents/IUC5-b372252f-eead-4ed3-911c-74c27ca89a9d_49132548-180d-466f-aee4-de33a1167b28.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Lubricating oils, used, vacuum distd.",92045-41-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5a58d75-0f34-412f-8d41-1bbe6afb9015/documents/IUC5-b372252f-eead-4ed3-911c-74c27ca89a9d_49132548-180d-466f-aee4-de33a1167b28.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, L-xylo-hex-2-ulosonic acid,526-98-7,The acute oral toxicity to male and female rats was examined at a limit dose of 2000 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06b13207-b295-4088-b7f0-8f0df87adb0f/documents/IUC5-087900df-416c-49ae-b02d-7723320409c4_8bbd8b29-8aa6-46e9-9c6f-a2544053cbd9.html,,,,,, L-xylo-hex-2-ulosonic acid,526-98-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06b13207-b295-4088-b7f0-8f0df87adb0f/documents/IUC5-087900df-416c-49ae-b02d-7723320409c4_8bbd8b29-8aa6-46e9-9c6f-a2544053cbd9.html,,oral,LD50,"2,000 mg/kg bw",, "Lyase, pectate",9015-75-2," The repeated dose inhalation and dermal toxicity were waived based on exposure considerations and the properties of the substance. Pectate lyase has not been tested orally, but an enzyme from the same class - pectin lyase - has been tested in rats. Oral administration (gavage) of pectin lyase to Sprague-Dawley rats at doses of 200.5, 661.5 and 2005 mg TOS/kg/day for a period of 13 weeks was generally well tolerated. No test item-related observations were made. Based on the results of this study, the no observed adverse effect level (NOAEL) for the test item pectin lyase was set at or above 2005 mg TOS/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/505a3000-3025-4228-8d87-16384e5d7f9e/documents/IUC5-92e4491f-89a4-41dc-9868-adcd858ecf85_9c3d9933-06d6-4ad9-aea4-94b573de4dde.html,,,,,, "Lyase, pectate",9015-75-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/505a3000-3025-4228-8d87-16384e5d7f9e/documents/IUC5-92e4491f-89a4-41dc-9868-adcd858ecf85_9c3d9933-06d6-4ad9-aea4-94b573de4dde.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,005 mg/kg bw/day",,rat "Lyase, pectate",9015-75-2," The acute toxicity of pectate lyase was tested by administration by gavage as a single oral dose to one group of five male and five female rats followed by an observation period of 14 days. The dose volume administered was 2x12 mL/kg bodyweight of the undiluted test material. No clinical signs were observed and the overall body weight gain during the study was normal. The post-mortem inspection revealed no abnormalities. In conclusion, no signs of toxicity were observed among the rats treated with a single oral dose of 2064 mg Total Organic Solids (TOS)/kg. abnormalities. In conclusion, no signs of toxicity were observed among the rats treated with a single oral dose of 2064 mg Total Organic Solids (TOS)/kg.   The acute inhalation toxicity of pectate lyase (batch number PPE 6345) was studied by nose-only exposure of one group of five male and five female rats each for a 4-hour period to a test atmosphere containing an aerosol of pectate lyase at a concentration of 5.07 ± 0.11 g/m3. The mass median aerodynamic diameter of the particles in the aerosol was 2.8 μm and the geometric standard deviation was 2.0. It was concluded that the 4-hour LC50 value of an aerosol of pectate lyase (Batch number PPE 6345) was larger than 5.07 g/m3 for both sexes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/505a3000-3025-4228-8d87-16384e5d7f9e/documents/IUC5-be3db9ad-3e20-4062-9e8d-35f6f0f3dbde_9c3d9933-06d6-4ad9-aea4-94b573de4dde.html,,,,,, "Lyase, pectate",9015-75-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/505a3000-3025-4228-8d87-16384e5d7f9e/documents/IUC5-be3db9ad-3e20-4062-9e8d-35f6f0f3dbde_9c3d9933-06d6-4ad9-aea4-94b573de4dde.html,,oral,LD50,"2,064 mg/kg bw",no adverse effect observed, "Lyase, pectate",9015-75-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/505a3000-3025-4228-8d87-16384e5d7f9e/documents/IUC5-be3db9ad-3e20-4062-9e8d-35f6f0f3dbde_9c3d9933-06d6-4ad9-aea4-94b573de4dde.html,,inhalation,LC50,"5,070 mg/m3",no adverse effect observed, "Lyase, pectin",9033-35-6, The acute median lethal oral dose (LD50) to rats of pectin lyase PPJ34366 was demonstrated to be greater than 2000 mg/kg bodyweight. There were no deaths during the study. There were no clinical signs of reaction to treatment throughout the study. All animals were considered to have achieved satisfactory bodyweight gains throughout the study. No abnormalities were noted in any animal at the macroscopic examination at study termination on Day 15. Pectin lyase PPJ34366 is included in Category 5 or unclassified according to the Globally Harmonised System (GHS). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7da81500-377c-4bb9-888f-c5cb78b51335/documents/0d1c8534-cb0c-42d1-810f-4b0922241ca3_d16b3509-b236-4ecd-b25a-03481c85a0be.html,,,,,, Lysergic acid,82-58-6, Oral: The oral LD50 value of the test item in Wistar rat was established to exceed 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5eb1ec6b-29b9-4901-b868-e25695816e7e/documents/9ab73b52-915d-42ec-8158-a913993c328c_31ac7450-d911-48bf-8eb8-7bfd3e216af2.html,,,,,, Lysergic acid,82-58-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5eb1ec6b-29b9-4901-b868-e25695816e7e/documents/9ab73b52-915d-42ec-8158-a913993c328c_31ac7450-d911-48bf-8eb8-7bfd3e216af2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, lysophospholipaseIUBMB 3.1.1.5,9001-85-8," It is concluded that oral administration of lysophospholipase to CD rats at dosages up to 10.0 ml/kg/day for 13 weeks was well-tolerated and did not produce any toxicological significant change. Consequently the no observed adverse effect level (NOAEL) in this study was considered to be the highest dose administered 10.0 ml/kg/day, which is the equivalent to 2.42 g TOS/kg/day. Based on repeated dose oral study and weight of evidence, lysophospholipase does not exert any repeated dose oral, dermal or inhalation toxicity to workers or consumers. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f80910e-52bd-42eb-af44-615cbec8b4a7/documents/ba773a37-f3aa-47f7-b9d9-fc1116d1b0e6_3e98d117-11fe-47db-b46a-6a0b158dd70c.html,,,,,, lysophospholipaseIUBMB 3.1.1.5,9001-85-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f80910e-52bd-42eb-af44-615cbec8b4a7/documents/ba773a37-f3aa-47f7-b9d9-fc1116d1b0e6_3e98d117-11fe-47db-b46a-6a0b158dd70c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,420 mg/kg bw/day",,rat lysophospholipaseIUBMB 3.1.1.5,9001-85-8, Lysophospholipase was tested orally in rats. No signs of toxicity were observed among the rats treated with a single oral dose of 2085 mg total organic solids/kg body weight for a period of 14 days. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f80910e-52bd-42eb-af44-615cbec8b4a7/documents/1fa976e2-74ef-42b3-8877-1c1561c1c5d4_3e98d117-11fe-47db-b46a-6a0b158dd70c.html,,,,,, lysophospholipaseIUBMB 3.1.1.5,9001-85-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f80910e-52bd-42eb-af44-615cbec8b4a7/documents/1fa976e2-74ef-42b3-8877-1c1561c1c5d4_3e98d117-11fe-47db-b46a-6a0b158dd70c.html,,oral,,"2,085 mg/kg bw",no adverse effect observed, Lysozyme (chicken egg white),12650-88-3,Lysozyme is expected to have no adverse local/systemic effects for repeated exposure. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6813b373-80c0-4c2b-9f92-05a006063da8/documents/IUC5-4a182071-fb9c-4c56-a2d2-887f12ef6f98_263c1aa8-986b-43b6-a420-e3c75b7cf67c.html,,,,,, Lysozyme (chicken egg white),12650-88-3,No adverse effect observed via oral route.No adverse effect observed via inhalation route.No adverse effect observed via dermal route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6813b373-80c0-4c2b-9f92-05a006063da8/documents/IUC5-1d189e6d-7bfd-4b88-a29e-f9ea138c671b_263c1aa8-986b-43b6-a420-e3c75b7cf67c.html,,,,,, Lysozyme (chicken egg white),12650-88-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6813b373-80c0-4c2b-9f92-05a006063da8/documents/IUC5-1d189e6d-7bfd-4b88-a29e-f9ea138c671b_263c1aa8-986b-43b6-a420-e3c75b7cf67c.html,,oral,LD50,"5,050 mg/kg bw",no adverse effect observed, Lysozyme (chicken egg white),12650-88-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6813b373-80c0-4c2b-9f92-05a006063da8/documents/IUC5-1d189e6d-7bfd-4b88-a29e-f9ea138c671b_263c1aa8-986b-43b6-a420-e3c75b7cf67c.html,,dermal,LD50,"5,050 mg/kg bw",no adverse effect observed, Lysozyme (chicken egg white),12650-88-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6813b373-80c0-4c2b-9f92-05a006063da8/documents/IUC5-1d189e6d-7bfd-4b88-a29e-f9ea138c671b_263c1aa8-986b-43b6-a420-e3c75b7cf67c.html,,inhalation,LC50,"2,510 mg/m3",no adverse effect observed, "Lysozyme, hydrochloride",9066-59-5,No chronic toxicity ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37549027-ce4f-4434-9447-70c2b32cb7d7/documents/IUC5-c88f0eb1-bb4f-4bb9-84a4-44151432aeca_18401a12-4a41-4cb9-a59f-24f17064b3ab.html,,,,,, "Lysozyme, hydrochloride",9066-59-5,Oral LD50 > 5050 mg/kg bwInhalation LD50 > 2.51 mg/lDermal LD50 > 5050 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37549027-ce4f-4434-9447-70c2b32cb7d7/documents/IUC5-3a9ef1d8-c10c-4e38-8266-8fbc6a2cf2f4_18401a12-4a41-4cb9-a59f-24f17064b3ab.html,,,,,, "Lysozyme, hydrochloride",9066-59-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37549027-ce4f-4434-9447-70c2b32cb7d7/documents/IUC5-3a9ef1d8-c10c-4e38-8266-8fbc6a2cf2f4_18401a12-4a41-4cb9-a59f-24f17064b3ab.html,,oral,LD50,"5,050 mg/kg bw",no adverse effect observed, "Lysozyme, hydrochloride",9066-59-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37549027-ce4f-4434-9447-70c2b32cb7d7/documents/IUC5-3a9ef1d8-c10c-4e38-8266-8fbc6a2cf2f4_18401a12-4a41-4cb9-a59f-24f17064b3ab.html,,dermal,LD50,"5,050 mg/kg bw",no adverse effect observed, "Lysozyme, hydrochloride",9066-59-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37549027-ce4f-4434-9447-70c2b32cb7d7/documents/IUC5-3a9ef1d8-c10c-4e38-8266-8fbc6a2cf2f4_18401a12-4a41-4cb9-a59f-24f17064b3ab.html,,inhalation,LC50,"2,510 mg/m3",no adverse effect observed, "m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline",71604-74-5," Two Repeat Dose Studies are available. In a GLP 28-day oral repeated dose study conducted in accordance with OECD 407 on the present substance. The systemic NOAEL was determined to be 50 mg/kg bw/day based on GI, stomach effects and atrophy of the female reproductive organs (uterus, cervix and vagina) observed at 150 mg/kg/day. In a GLP, 90 day, repeat dose oral study conducted in accordance with OECD TG 408, administration of the read across source substance )p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl) aniline) to Han Wistar rats for 13 weeks did not cause any toxicologically significant finding. Mucosal hyperplasia was present in the duodenum of males and females which received 5 or 15 mg/kg/day but was considered to be an adaptive response associated with local irritation and non-adverse. The no-observed-adverse-effect level (NOAEL) in this study was considered to be 15 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d05c2c14-89e2-4618-a386-bcc376334770/documents/5b645b30-fd02-4351-a0f3-6827275e979a_6eec65e6-73ef-4464-9929-04b3fd68c14c.html,,,,,, "m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline",71604-74-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d05c2c14-89e2-4618-a386-bcc376334770/documents/5b645b30-fd02-4351-a0f3-6827275e979a_6eec65e6-73ef-4464-9929-04b3fd68c14c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline",71604-74-5,"Acute oral and dermal studies with m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline performed in accordance with current OECD/EC test guidelines and GLP principles, showed LD50 values of 300-2000 mg/kg bw for acute oral toxicity, and of > 2000 mg/kg for acute dermal toxicity in rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d05c2c14-89e2-4618-a386-bcc376334770/documents/IUC5-2d1d8ff4-2054-4769-8bbc-91207309e26c_6eec65e6-73ef-4464-9929-04b3fd68c14c.html,,,,,, "m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline",71604-74-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d05c2c14-89e2-4618-a386-bcc376334770/documents/IUC5-2d1d8ff4-2054-4769-8bbc-91207309e26c_6eec65e6-73ef-4464-9929-04b3fd68c14c.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, "m-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline",71604-74-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d05c2c14-89e2-4618-a386-bcc376334770/documents/IUC5-2d1d8ff4-2054-4769-8bbc-91207309e26c_6eec65e6-73ef-4464-9929-04b3fd68c14c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "m,m'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[2,4,6-trimethylbenzenesulphonic] acid, compound with hexane-1,6-diamine (1:1)",79665-26-2, The oral LD50 exceeds 8000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8abb98a2-f278-4d9f-a0d8-3bc1aa26281b/documents/e9deef53-6755-41b0-86d9-cadbf5b7584a_e2b1b148-bedb-4c52-82fc-b184d3065637.html,,,,,, "m,m'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[2,4,6-trimethylbenzenesulphonic] acid, compound with hexane-1,6-diamine (1:1)",79665-26-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8abb98a2-f278-4d9f-a0d8-3bc1aa26281b/documents/e9deef53-6755-41b0-86d9-cadbf5b7584a_e2b1b148-bedb-4c52-82fc-b184d3065637.html,,oral,discriminating dose,"8,000 mg/kg bw",no adverse effect observed, "m,m'-[carbonylbis[imino(3-methoxy-p-phenylene)azo]]bis(benzenesulphonic) acid, compound with 2,2'-iminodiethanol (1:2)",71550-21-5," In a preliminary toxicity study by oral gavage administration to Crl:CD(SD) rats for 14 days at 100 mg/kg bw none of the animals died. In the next higher dose group treatment with Bayscript Yellow GGN at 500 mg/kg/day was not tolerated. The male and female animals were found dead or were killed by animal welfare grounds after several days. A subacute OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity in Rodents) study is available. Three groups, each comprising five male and five female Crl:CD(SD) rats, received Bayscript Yellow GGN at doses of 10, 30 or 70 mg/kg/day at a volume dose of 5 mL/kg body weight. A similarly constituted control group received the vehicle, purified water, at the same volume dose over the same period.  During the study, clinical condition, detailed physical examination and arena observations, sensory reactivity, grip strength, motor activity, body weight, food consumption, water consumption (visual assessment), hematology (peripheral blood), blood chemistry, urinalysis, organ weight, macropathology and histopathology investigations were undertaken. The oral (gavage) administration of Bayscript Yellow GGN at a dose level of 70 mg/kg/day was associated with adverse pathological changes in the kidneys of males and females, consisting of tubular basophilia, tubular dilatation, and in males, additionally tubular crystal formation and inflammation.  There were associated changes in kidney weights and in plasma biochemical and urinary markers of renal function.  Similar treatment-related changes were not observed in animals given 10 or 30 mg/kg/day, therefore within the context of this study the No Observed Adverse Effect Level was concluded to be 30 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2789c27-3850-4c82-91d2-39e1cff125dd/documents/bb62c1a6-1594-4fb0-af21-a12fabcc4b82_8ef1afce-169b-4753-95a6-570fa9a5b055.html,,,,,, "m,m'-[carbonylbis[imino(3-methoxy-p-phenylene)azo]]bis(benzenesulphonic) acid, compound with 2,2'-iminodiethanol (1:2)",71550-21-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2789c27-3850-4c82-91d2-39e1cff125dd/documents/bb62c1a6-1594-4fb0-af21-a12fabcc4b82_8ef1afce-169b-4753-95a6-570fa9a5b055.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "m,m'-[carbonylbis[imino(3-methoxy-p-phenylene)azo]]bis(benzenesulphonic) acid, compound with 2,2'-iminodiethanol (1:2)",71550-21-5, The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2126 mg/kg body weight (equivalent to 2000 mg active ingredient/kg body weight). There were no deaths. The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2240 mg/kg body weight (equivalent to 2000 mg active ingredient/kg body weight). No acute inhalation toxicity study is available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2789c27-3850-4c82-91d2-39e1cff125dd/documents/e7f8c340-cd69-4eb3-a8e3-8e92445b64fe_8ef1afce-169b-4753-95a6-570fa9a5b055.html,,,,,, "m,m'-[carbonylbis[imino(3-methoxy-p-phenylene)azo]]bis(benzenesulphonic) acid, compound with 2,2'-iminodiethanol (1:2)",71550-21-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2789c27-3850-4c82-91d2-39e1cff125dd/documents/e7f8c340-cd69-4eb3-a8e3-8e92445b64fe_8ef1afce-169b-4753-95a6-570fa9a5b055.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "m,m'-[carbonylbis[imino(3-methoxy-p-phenylene)azo]]bis(benzenesulphonic) acid, compound with 2,2'-iminodiethanol (1:2)",71550-21-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2789c27-3850-4c82-91d2-39e1cff125dd/documents/e7f8c340-cd69-4eb3-a8e3-8e92445b64fe_8ef1afce-169b-4753-95a6-570fa9a5b055.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Magnesium 2,3,4,5,6,7-Hexahydroxyheptanoate",1821694-26-1," Magnesium glucoheptonate is a medicine used against antihypomagnaesemia and can be administered to patients orally at dose levels of 158-396 mg/kg bw. In old animal studies, LD50 of 21,260 and 18,170 mg/kg bw were reported for white mouse and rat, respectively. To prove the reliability of these values, data on structurally similar calcium and magnesium gluconates were taken into account. Additionally, acute hazard profile of several organic and inorganic magnesium salts and compounds was considered. Calcium glucoheptonate, similarly to magnesium glucoheptonate, is a therapeutic drug against hypocalcaemia in animals and humans and is used as an imaging agent in nuclear medicine. Acute toxicity of gluconates is very low (LD50 > 5000 mg/kg bw) in different species. Moreover, calcium and magnesium gluconates are recognised as safe (GRAS) and are notified as dietary supplements. Thus, no acute toxicity by oral route can be attributed to sugar-like glucoheptonate ion. Acute oral toxicity of elemental magnesium is low. LD50 of greater than 2000 mg/kg bw were reported for several magnesium salts and compounds in various species. Considering the reported rat LD50 of 660 mg/kg bw for element magnesium obtained in an acute study with MAH, and providing that toxicity would depend on excess of magnesium, the corresponding dose of 7238 mg/kg bw could be calculated for magnesium glucoheptonate. In conclusion, LD50 of 21,260 and 18,170 mg/kg bw for mice and rats, respectively, have been considered to be reliable and can be used as key values in this dossier. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e60bbfd6-b000-489f-a42e-466914cd082b/documents/IUC5-a940b7d3-9b34-4ba2-8705-397ac57d4d93_bcd47e33-9e85-4a4d-b17e-ec75910c53bb.html,,,,,, "Magnesium 2,3,4,5,6,7-Hexahydroxyheptanoate",1821694-26-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e60bbfd6-b000-489f-a42e-466914cd082b/documents/IUC5-a940b7d3-9b34-4ba2-8705-397ac57d4d93_bcd47e33-9e85-4a4d-b17e-ec75910c53bb.html,,oral,LD50,"18,170 mg/kg bw",no adverse effect observed, Magnesium 2-ethylhexanoate,15602-15-0," No repeated dose toxicity study with magnesium 2-ethylhexanoate is available, thus the repeated dose toxicity will be addressed with existing data on the assessment entities magnesium and 2‑ethylhexanoic acid. In relevant and reliable repeated dose toxicity studies for both assessment entities of magnesium 2‑ethylhexanoate, there were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c690f688-51ee-4347-a6be-70045d4b68f3/documents/71e8ba9a-5d6e-48b6-b692-abadea2a7648_fdfd3322-6557-40bf-8892-1b74b534e69d.html,,,,,, Magnesium 2-ethylhexanoate,15602-15-0," No acute toxicity studies with magnesium 2-ethylhexanoate are available, thus the acute toxicity will be addressed with existing data on the assessment entities magnesium and 2-ethylhexanoic acid. Signs of acute oral or acute dermal toxicity are not expected for magnesium 2-ethylhexanoate, since the two moieties magnesium and 2-ethylhexanoic acid have not shown signs of acute oral or acute dermal toxicity in experimental testing (both LD50 > 2000mg/kg) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c690f688-51ee-4347-a6be-70045d4b68f3/documents/12ecd5b8-c9b6-48c3-9122-5af0fc65bb92_fdfd3322-6557-40bf-8892-1b74b534e69d.html,,,,,, Magnesium acrylate,5698-98-6,"The data for the toxicity after repeated oral and inhalative administration are taken from a fully reliable studies with administraion of acrylic acid. Acrylic acid is the corresponding organic acid of Magnesium acrylate. The toxic effects of Acrylic acid are mainly caused by its irritating properties. In contrast to the free organic acid Magnesium acrylate has nearly no irritating properties as the studies for irritation and corrosion show. As the effect levels of acrylic acid are mainly determined by its irritating properties a read across to Magnsium acrylate will overestimate the toxicity. That means the effect levels of Magnesium acrylate should be considerably higher. Therefore the results of the studies with acrylic acid can be taken as a worst case to evaluate the oral and inhalative repeated dose toxicity of Magnesium acrylate.Acrylic acid:- NOEL after 90 day oral administration via drinking water to rats: 40 mg/kg bw/d (male rats), 83 mg/kg bw/d (female rats)- NOAEC for systemic effects after 90 day inhalative exposure to rats: 75 mg/m³There exist only one study with acute dermal application of Magnesium acrylate. In this study Magnesium acrylate was applied to the skin of rats uniformly over a skin area of 4x4 cm² and the test area was bandaged for an exposure time of 24 hours.  No signs of toxicity whatsoever were seen. On the other hand the dermal application of Acrylic acid caused markable irritation to the skin. The European Union Risk Assessment Report Acrylic Acid, Volume 28 ISBN 92-894-1272-0 (EU, 2002) cites a 13 week dermal toxicity study with mice. Mice were treated with 4% , 1% and 0% acrylic acid in acetone on 3 days per week for 13 weeks. While skin irritation became prevalent with 4% acrylic acid, no irritant effect was evident after long-term application of 1% acrylic acid solution. This should be also true for solutions of Magnesium acrylate. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96054917-838e-4d75-825d-76c46f83e3c5/documents/IUC5-7d137df6-270e-474e-8d29-5e5238e6128b_c28df993-873d-49b2-bb00-c20c638d2b63.html,,,,,, Magnesium acrylate,5698-98-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96054917-838e-4d75-825d-76c46f83e3c5/documents/IUC5-7d137df6-270e-474e-8d29-5e5238e6128b_c28df993-873d-49b2-bb00-c20c638d2b63.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,83 mg/kg bw/day,,rat Magnesium acrylate,5698-98-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96054917-838e-4d75-825d-76c46f83e3c5/documents/IUC5-7d137df6-270e-474e-8d29-5e5238e6128b_c28df993-873d-49b2-bb00-c20c638d2b63.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,221 mg/m3,,mouse Magnesium acrylate,5698-98-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96054917-838e-4d75-825d-76c46f83e3c5/documents/IUC5-7d137df6-270e-474e-8d29-5e5238e6128b_c28df993-873d-49b2-bb00-c20c638d2b63.html,Repeated dose toxicity – local effects,inhalation,NOAEC,74 mg/m3,adverse effect observed,mouse Magnesium acrylate,5698-98-6,"The main and most relevant toxic effects of the reference substance acrylic acid are the corrosive properties. Magnesium acrylate is the magnesium salt of the organic acid acrylic acid. As the study on irritation and corrosion showed, Magesium acrylate has practically no corrosive and only weak irritative properties not leading to classification and labelling. Additionally the metabolism studies showed, that ingested acrylic acid is rapidly and completly metabolised. This should be true also for Magnesium acrylate. As a consequence Magesium acrylate has only a weak toxicity.Acute toxicity via oral route: LD50 > 2000 mg/kg bwAcute toxicity via dermal route: LD50 > 2000 mg/kg bwInhalation: no study availableMagnesium acrlyate is a salt, the melting point of the solid is higher than 300°C. Exposure of humans via inhalation by aerosols, particles or droplets of an inhalable size is not possible during manufacturing or application of the aqueous magnesium acrylate solution (concentration <50%). See Annex VIII column 2 under point 8.5.2 of the REACH regulation. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96054917-838e-4d75-825d-76c46f83e3c5/documents/IUC5-9bc1165a-f50d-4a44-b60d-8cb09588305b_c28df993-873d-49b2-bb00-c20c638d2b63.html,,,,,, Magnesium bis(dihydrogenorthophosphate),13092-66-5, There are currently no reliable experimental data available to assess repeated dose toxicity for magnesium bis(dihydrogenorthophosphate) A data waiver is set in place to justify that no further repeated dose toxicity testing is required. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e33b2fec-70c5-4480-bc78-99e8dbae669b/documents/79a9c32c-7c42-42f0-a047-7606bb26eb34_eaea40b2-9772-4ff7-bd06-f060fb400c8e.html,,,,,, Magnesium bis(dihydrogenorthophosphate),13092-66-5,"Key studies are available for acute oral and acute inhalation toxicity. These studies are performed under the conditions of GLP and to an appropriate OECD guideline. As such, these studies are considered to be adequate and reliable for use a key studies for the purpose of REACH Registration and classification and labelling in accordance with EU CLP. It is not considered necessary to provide acute dermal toxicity data on the basis of the physiochemical and toxicological properties of magnesium bis(dihydrogenorthophosphate). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e33b2fec-70c5-4480-bc78-99e8dbae669b/documents/IUC5-77b11855-6d03-40b0-9f7d-d17eaa1097f6_eaea40b2-9772-4ff7-bd06-f060fb400c8e.html,,,,,, Magnesium bis(dinonylnaphthalenesulphonate),28015-99-8,"OECD 422 studies were conducted with 2 analogues: DNNSA (di C8-C10, branched, C9 rich, alkylnaphthalene sulphonic acid) and Barium DNNSA (Barium bis( di C8-C10, branched, C9 rich, alkylnaphthalene sulphonate). The NOAEL for DNNSA is 95 mg/kg/day and the NOAEL for Barium DNNSA is 55 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac04abcc-fdaa-41ed-b26e-40864051f94e/documents/IUC5-f280d496-60bc-40da-8508-e56a0a4e547c_086a7b4b-50f3-4e3c-8b91-82e22d6d8f57.html,,,,,, Magnesium bis(dinonylnaphthalenesulphonate),28015-99-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac04abcc-fdaa-41ed-b26e-40864051f94e/documents/IUC5-f280d496-60bc-40da-8508-e56a0a4e547c_086a7b4b-50f3-4e3c-8b91-82e22d6d8f57.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,95 mg/kg bw/day,,rat Magnesium bis(dinonylnaphthalenesulphonate),28015-99-8,"Acute oral toxicityFive rats/sex received a dose of ca. 2500 mg/kg bw of the test substance (PSL 1981). Two females died on day 1. Other animals survived until the end of the 14 day observation period. No effects on body weight, clinical signs and macroscopic findings were reported except in the deceased animals. The LD50 of the testsubstance is > 2500 mg/kg bw.Studies on the analogues DNNSA and BaDNNSA showed LD50 values of > 2000 mg/kg bw and 1750 mg/kg bw respectivelyAcute inhalation toxicityRats (5/sex) were exposed to the test substance at 2.6 mg/L by inhalation (PSL 1981). No mortality, clinical signs or effects on body weight were observed. It is therefore concluded that the LC50 is >2.6 mg/L. Analytical information on the actual concentration in the test chamber is not provided.Acute dermal toxicityThe test substance did not induce mortality in an acute dermal toxicity study (PSL 1980). As part of the animals had an abraded skin, this represents a worst case situation. It is therefore concluded that the test substance is of low acute toxicity.Studies on formulations of the analogues DNNSA and BaDNNSA showed LD50 values of > 1000 mg/kg bw (as active ingredient). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac04abcc-fdaa-41ed-b26e-40864051f94e/documents/IUC5-0e63212c-225a-4386-9d1a-5272f62d559d_086a7b4b-50f3-4e3c-8b91-82e22d6d8f57.html,,,,,, Magnesium bis(dinonylnaphthalenesulphonate),28015-99-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac04abcc-fdaa-41ed-b26e-40864051f94e/documents/IUC5-0e63212c-225a-4386-9d1a-5272f62d559d_086a7b4b-50f3-4e3c-8b91-82e22d6d8f57.html,,oral,discriminating dose,"2,500 mg/kg bw",adverse effect observed, Magnesium bis(dinonylnaphthalenesulphonate),28015-99-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac04abcc-fdaa-41ed-b26e-40864051f94e/documents/IUC5-0e63212c-225a-4386-9d1a-5272f62d559d_086a7b4b-50f3-4e3c-8b91-82e22d6d8f57.html,,dermal,discriminating dose,"1,000 mg/kg bw",no adverse effect observed, Magnesium diethyl dicarbonate,16891-37-5," Magnesium diethyl dicarbonate rapidly hydrolyzes in aqueous environments (t1/2 < 1 minute) into carbon dioxide, ethanol and magnesium hydroxide (detailed description in section 5.1.2). Carbon dioxide is a natural gas. Valid study data on acute oral toxicity are available for the intermediate hydrolysis product magnesium ethanolate, as well as for the final hydrolysis products magnesium hydroxide and ethanol. Intermediate hydrolysis product magnesium ethanolate The intermediate hydrolysis product magnesium ethanolate showed an LD50 > 3160 mg/kg bw in a limit test equivalent to OECD TG 423 with male rats. Hydrolysis product magnesium hydroxide The final hydrolysis product magnesium hydroxide showed an LD50 (cut-off) > 5000 mg/kg bw in a limit test equivalent to OECD TG 423 under GLP with rats. Hydrolysis product ethanol The final hydrolysis product ethanol is a well-known substance of low oral toxicity. Several studies according to varying OECD guidelines have been included as a weight of evidence approach. The LD50 exceeded 5000 mg/kg bw in all of these studies. An inhalatory LC50 for ethanol could not be obtained; no deaths were reported for exposures up to 60,000ppm (114mg/l), which can be considered the saturated vapor concentration. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4405b0a0-52e7-4dd7-9651-744833464e6c/documents/5880b41c-1d44-4a8b-87ed-0399c816f264_19cfbfc0-18aa-4867-a99f-3ae9de53d427.html,,,,,, Magnesium diethyl dicarbonate,16891-37-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4405b0a0-52e7-4dd7-9651-744833464e6c/documents/5880b41c-1d44-4a8b-87ed-0399c816f264_19cfbfc0-18aa-4867-a99f-3ae9de53d427.html,,oral,discriminating dose,"5,000 mg/kg bw",, Magnesium dihydrogen disulphite,13774-25-9,"A 3-generation chronic toxicity study (Til et al. 1972a) with treatment of rats (20 per sex and group) with dose levels of 0, 0.125, 0.25, 0.5, 1.0 or 2.0% Na2S2O5 administered in a 50 ppm thiamine-containing diet was identified as most reliable study for repeated dose toxicity and was defined as key study (read-across info, see `discussion`). Based on the read across concept for the group of sulfite substances, this result is also applicable to magnesium hydrogensulfite. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7807fcaa-efbe-47de-9c08-68eeb85f5e68/documents/IUC5-17527472-5f02-402a-83df-b361d9179b41_fd9a1088-8ba4-490d-8b21-923221b3745d.html,,,,,, Magnesium dihydrogen disulphite,13774-25-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7807fcaa-efbe-47de-9c08-68eeb85f5e68/documents/IUC5-17527472-5f02-402a-83df-b361d9179b41_fd9a1088-8ba4-490d-8b21-923221b3745d.html,Chronic toxicity – systemic effects,oral,NOAEL,107 mg/kg bw/day,,rat Magnesium dihydrogen disulphite,13774-25-9,"Based on the described read-across methodology information from sodium sulfite (CAS 7757-83-7), sodium metabisulfite (CAS 7681 -57 -4) and potassium metabisulfite (CAS 16731 -55 -8) were used to determine acute toxicity values (oral, dermal and inhalative) for magnesium dihydrogensulfite.Please see `discussion` below. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7807fcaa-efbe-47de-9c08-68eeb85f5e68/documents/IUC5-e0829582-3ffc-4beb-94bf-8163d8074166_fd9a1088-8ba4-490d-8b21-923221b3745d.html,,,,,, Magnesium dimetaphosphate,13573-12-1, There are currently no reliable experimental data available to assess repeated dose toxicity for magnesium dimetaphosphate. A data waiver is set in place to justify that no further repeated dose toxicity testing is required. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6798e86c-6659-402f-b1ae-c9adfac82b3e/documents/cdcf9898-b3ef-4874-aa94-5e946f62fc48_75b851b1-fb2a-4e72-9a9d-45289baa7867.html,,,,,, Magnesium dimetaphosphate,13573-12-1," There is no data regarding acute toxicity via oral or inhalation route available for magnesium dimetaphosphate. Read across data with calcium bis (dihydrogenorthophosphate) CAS 7758 -23 -8 and trimagnesium bis(orthophosphate) CAS 7757 -87 -1 is used and considered reliable. Oral (OECD420, CAS 7757 -87 -1, RL1), rat LD50 > 2000 mg/kg bw (limit test) Inhalation (OECD 403, CAS 7758 -23 -8, RL1), rat LC50 > 2.6 mg/L air (limit test) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6798e86c-6659-402f-b1ae-c9adfac82b3e/documents/d4e8a81a-922f-4c4d-9986-ab52a70f2414_75b851b1-fb2a-4e72-9a9d-45289baa7867.html,,,,,, Magnesium dimetaphosphate,13573-12-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6798e86c-6659-402f-b1ae-c9adfac82b3e/documents/d4e8a81a-922f-4c4d-9986-ab52a70f2414_75b851b1-fb2a-4e72-9a9d-45289baa7867.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Magnesium dimetaphosphate,13573-12-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6798e86c-6659-402f-b1ae-c9adfac82b3e/documents/d4e8a81a-922f-4c4d-9986-ab52a70f2414_75b851b1-fb2a-4e72-9a9d-45289baa7867.html,,inhalation,LC50,"2,600 mg/m3",no adverse effect observed, Magnesium diniobate,12163-26-7," A repeated dose toxicity study with magnesium diniobate is not available, thus the repeated dose toxicity will be addressed with existing data on the individual constituents magnesium and niobium. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a59bc49-6f3b-4893-b12e-17f4d68a3ead/documents/355ee560-8dcc-4d93-a6d5-a3f4f0c317cd_897f926e-04a0-45c7-9ac6-8ce668ecce93.html,,,,,, Magnesium diniobate,12163-26-7," Acute toxicity studies with magnesium diniobate are not available, thus the acute toxicity will be addressed with existing data on the dissociation products. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a59bc49-6f3b-4893-b12e-17f4d68a3ead/documents/907918a0-5ed6-4b91-9e7c-cfac8bd33bec_897f926e-04a0-45c7-9ac6-8ce668ecce93.html,,,,,, Magnesium dipropan-2-olate,15571-48-9, Magnesium isopropanolate rapidly hydrolyzes in aqueous environments. Toxicity is mediated by its degradation products isopropanol and Mg(OH)2 and assessed for these products. Isopropanol Isopropanol is associated with low acute oral toxicity. The oral LD50 was reported to be 5840 mg/kg body weight in rats after administering the test article by gavage. Mg(OH)2 Oral: LD50 > 2000 mg/kg bw for rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/81b27ba0-935a-482a-8bdc-ad8db4c09178/documents/48dd6145-bd59-44bb-985e-145f38408fe8_8dd7e725-53e5-411c-a9f5-065a8bcc17ad.html,,,,,, Magnesium ethanolate,2414-98-4," Magnesium ethanolate rapidly hydrolyzes in aqueous environments (t1/2 < 1 minute) into ethanol and magnesium hydroxide (detailed description in section 5.1.2). Magnesium ethanolate showed an LD50 > 3160 mg/kg bw in a limit test equivalent to OECD TG 423 with male rats. Additional valid study data on acute oral toxicity are available for the hydrolysis products magnesium hydroxide and ethanol.   Hydrolysis product magnesium hydroxide The hydrolysis product magnesium hydroxide showed an LD50 (cut-off) > 5000 mg/kg bw in a limit test equivalent to OECD TG 423 under GLP with rats.   Hydrolysis product ethanol The hydrolysis product ethanol is a well-known substance of low oral toxicity. Several studies according to varying OECD guidelines have been included as a weight of evidence approach. The LD50 exceeded 5000 mg/kg bw in all of these studies. An inhalatory LC50 for ethanol could not be obtained; no deaths were reported for exposures up to 60,000ppm (114mg/l), which can be considered the saturated vapor concentration. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a133e89-55e8-4dd0-8b11-3eea2de3f17b/documents/1f188402-ecb7-4003-896d-8890b0f113e6_5aba4f27-a9e2-4138-81ef-0a50e799467c.html,,,,,, Magnesium ethanolate,2414-98-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a133e89-55e8-4dd0-8b11-3eea2de3f17b/documents/1f188402-ecb7-4003-896d-8890b0f113e6_5aba4f27-a9e2-4138-81ef-0a50e799467c.html,,oral,discriminating dose,"5,000 mg/kg bw",, Magnesium hydroxide sulphate trihydrate,12508-61-1," ORAL, OECD 407 28 day NOEL = 1000 mg/kg/day, male/female (rat) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8727b931-d264-4d41-bfec-c86c1789c0b6/documents/IUC5-6d33474e-8fa3-4f28-b9b3-02cb1a042daa_3bd0d7bb-c7fe-49a9-a641-400e9088baee.html,,,,,, Magnesium hydroxide sulphate trihydrate,12508-61-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8727b931-d264-4d41-bfec-c86c1789c0b6/documents/IUC5-6d33474e-8fa3-4f28-b9b3-02cb1a042daa_3bd0d7bb-c7fe-49a9-a641-400e9088baee.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Magnesium hydroxide sulphate trihydrate,12508-61-1," Testing was carried out on the following endpoints using the following guidelines: Acute toxicity: Oral - OECD Guidelines for the Testing of Chemicals No. 423 “Acute Oral Toxicity – Acute Toxic Class Method” (adopted 17 December 2001). Acute Toxicity: Dermal - OECD Guidelines for the Testing of Chemicals No. 402 “Acute Dermal Toxicity” (adopted 24 February 1987). Acute Toxicity: Inhalation was not performed due to the physico-chemical properties of the substance and the exposure scenario of the identified uses. The above studies have all been ranked reliability 1 according to the Klimisch system. This ranking was deemed appropriate because the studies were conducted to GLP and in compliance with agreed protocols, with no or minor deviations from standard test guidelines and/or minor methodological deficiencies, which do not affect the quality of the relevant results. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8727b931-d264-4d41-bfec-c86c1789c0b6/documents/IUC5-247ceabd-2db5-4d35-8f32-e236512863ba_3bd0d7bb-c7fe-49a9-a641-400e9088baee.html,,,,,, Magnesium hydroxide sulphate trihydrate,12508-61-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8727b931-d264-4d41-bfec-c86c1789c0b6/documents/IUC5-247ceabd-2db5-4d35-8f32-e236512863ba_3bd0d7bb-c7fe-49a9-a641-400e9088baee.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Magnesium hydroxide sulphate trihydrate,12508-61-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8727b931-d264-4d41-bfec-c86c1789c0b6/documents/IUC5-247ceabd-2db5-4d35-8f32-e236512863ba_3bd0d7bb-c7fe-49a9-a641-400e9088baee.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Magnesium metaborate,13703-82-7," Repeated dose - oral toxicity, OECD 422 screening study: NOAEL for systemic toxicity was considered to be 125 mg/kg/day based on lower body weights, body weight gains, and reduced food consumption in the 300 mg/kg/day group males and females. The NOAEL for neonatal toxicity was 50 mg/kg/day based on lower pup body weights and body weight gains at 125 and/or 300 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/070a9148-cb2c-4e8f-8ccd-d2eced99fce5/documents/54323c86-fbd2-4dfc-bc71-cfe8772c743d_1d0c216a-4e30-4e96-84c4-6a1032351214.html,,,,,, Magnesium metaborate,13703-82-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/070a9148-cb2c-4e8f-8ccd-d2eced99fce5/documents/54323c86-fbd2-4dfc-bc71-cfe8772c743d_1d0c216a-4e30-4e96-84c4-6a1032351214.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Magnesium metaborate,13703-82-7," Acute oral toxicity in the rat, OECD 420: LD50oral > 2000 mg/kg bw Acute dermal toxicty in the rat, OECD 402: LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/070a9148-cb2c-4e8f-8ccd-d2eced99fce5/documents/5cc87a88-f24a-4f9b-ac59-9dfe63b5ee8d_1d0c216a-4e30-4e96-84c4-6a1032351214.html,,,,,, Magnesium metaborate,13703-82-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/070a9148-cb2c-4e8f-8ccd-d2eced99fce5/documents/5cc87a88-f24a-4f9b-ac59-9dfe63b5ee8d_1d0c216a-4e30-4e96-84c4-6a1032351214.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Magnesium metaborate,13703-82-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/070a9148-cb2c-4e8f-8ccd-d2eced99fce5/documents/5cc87a88-f24a-4f9b-ac59-9dfe63b5ee8d_1d0c216a-4e30-4e96-84c4-6a1032351214.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Magnesium neodecanoate,57453-97-1," No repeated dose toxicity study with magnesium neodecanoate is available, thus the repeated dose toxicity will be addressed with existing data on the individual moieties magnesium and neodecanoic acid. In relevant and reliable repeated dose toxicity studies as well as supporting studies for both moieties of magnesium neodecanoate, there were no toxicological findings reported that would justify a classification for specific target organ toxicity - repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b9c8b853-7cd9-4ed1-b993-0701c3122a1f/documents/0da7e4bb-7cc4-4eeb-8fc4-d34fc6a72ffe_edc8a0a4-0ece-4b47-9c2c-990cbc819d9a.html,,,,,, Magnesium neodecanoate,57453-97-1," No acute toxicity studies with magnesium neodecanoate are available, thus the acute toxicity will be addressed with existing data on the individual moieties magnesium and neodecanoic acid. Signs of acute oral or acute dermal toxicity are not expected for magnesium neodecanoate, since the two moieties magnesium and neodecanoic acid have not shown signs of acute oral or acute dermal toxicity in experimental testing (both LD50 > 2000mg/kg). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b9c8b853-7cd9-4ed1-b993-0701c3122a1f/documents/e6831fcd-72ce-426c-bd84-252ec359ebaf_edc8a0a4-0ece-4b47-9c2c-990cbc819d9a.html,,,,,, Magnesium octadecylbenzenesulphonate,31242-17-8," In this OECD407 study, a No Observed Adverse Effect Level (NOAEL) for the test material of 300 mg/kg was established based on the presence of multifocal necrosis of the liver in one male at 1000 mg/kg, and the magnitude of change of primarily alanine aminotransferase activity at 1000 mg/kg, in combination with other clinical biochemistry changes that point to a disturbance in liver function. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f2050b0-88d6-4ce1-9718-fa6c60a86f01/documents/7a56df56-de38-458b-a1a9-7fe259f43805_1068e498-e95e-4476-abeb-e8be5e249b44.html,,,,,, Magnesium octadecylbenzenesulphonate,31242-17-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f2050b0-88d6-4ce1-9718-fa6c60a86f01/documents/7a56df56-de38-458b-a1a9-7fe259f43805_1068e498-e95e-4476-abeb-e8be5e249b44.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Magnesium octadecylbenzenesulphonate,31242-17-8, The oral LD50 value for the source substance was established to exceed 2000 mg/kg body weight. The dermal LD50 value for the source substance was established to exceed 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f2050b0-88d6-4ce1-9718-fa6c60a86f01/documents/d9d89cdc-d6fc-481a-8e16-0df9bd4823e6_1068e498-e95e-4476-abeb-e8be5e249b44.html,,,,,, Magnesium oxalate,547-66-0," A 90 days study (OECD 408) was conducted on wistar rat (male/female) to assess the toxicity of oxalic acid via oral route. This study is used in a read across approach to assess the toxicity of magnesium oxalate. No treatment related effects were observed (e.g. functional observation battery, hematology, clinical biochemistry, adrenals, and thymus). The effects observed were due to species, strain, age, biological variation, incidental, congenital and/or physiology related. No Observed Adverse Effect Level (NOAEL) –  1000 ppm. This value corresponds to 63 mg/kg bw/d, according to calculations ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed110e55-4f84-425f-ac27-b6b8d275d63d/documents/f3074909-738a-44d2-86cd-ec5a2b1f0f3f_896a14ed-f1a3-4130-b1a6-24e39568b26b.html,,,,,, Magnesium oxalate,547-66-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed110e55-4f84-425f-ac27-b6b8d275d63d/documents/f3074909-738a-44d2-86cd-ec5a2b1f0f3f_896a14ed-f1a3-4130-b1a6-24e39568b26b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,63 mg/kg bw/day,,rat Magnesium oxalate,547-66-0, The LD50 of the test item Magnesium oxalate is higher than 2000 mg/ kg body weight by oral route in the rat. The LD50 of the test item Magnesium oxalate is higher than 2000 mg/ kg body weight by dermal route in the rat. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed110e55-4f84-425f-ac27-b6b8d275d63d/documents/f9340c79-cf97-465f-bf29-073361bcef78_896a14ed-f1a3-4130-b1a6-24e39568b26b.html,,,,,, Magnesium oxalate,547-66-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed110e55-4f84-425f-ac27-b6b8d275d63d/documents/f9340c79-cf97-465f-bf29-073361bcef78_896a14ed-f1a3-4130-b1a6-24e39568b26b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Magnesium oxalate,547-66-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed110e55-4f84-425f-ac27-b6b8d275d63d/documents/f9340c79-cf97-465f-bf29-073361bcef78_896a14ed-f1a3-4130-b1a6-24e39568b26b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Magnesium perchlorate,10034-81-8," acute tox (oral) LD50 = 1490 mg/kg b.w. (prediction by OECD QSAR Toolbox v4.3.1, 2019; based on experimental results of closely related analogues Potassium perchlorate and Lithium perchlorate) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df23d09e-ebef-4656-8e93-2a65a4202a98/documents/fdec9da8-81e7-460e-9ce4-fc8692041ef8_fce5bf63-c69e-4508-b8cd-55c8fa601493.html,,,,,, Magnesium perchlorate,10034-81-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df23d09e-ebef-4656-8e93-2a65a4202a98/documents/fdec9da8-81e7-460e-9ce4-fc8692041ef8_fce5bf63-c69e-4508-b8cd-55c8fa601493.html,,oral,LD50,"1,490 mg/kg bw",adverse effect observed, Magnesium Potassium Titanium Oxide,39290-90-9,"No adverse effects at the concentration limit of 1000 mg/kg bw/day in the sub-acute repeated dose toxicity study (EC B.7/OECD 407) with rats were noted. NOAEL is >= 1000 mg/kg bw/day. In a 90-day inhalation toxicity study according to OECD/EPA test guidelines, no adverse effects were noted at the highest dose tested, 50 mg/m3. Therefore the NOAEL is >= 50 mg/m3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfb1a5f1-1c75-4931-a365-cbb4f23902fa/documents/IUC5-50cced93-74d9-4e20-8fe0-eaacff7ca5b4_bcefdf04-9faa-4aae-8787-3414530dbdd2.html,,,,,, Magnesium Potassium Titanium Oxide,39290-90-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfb1a5f1-1c75-4931-a365-cbb4f23902fa/documents/IUC5-50cced93-74d9-4e20-8fe0-eaacff7ca5b4_bcefdf04-9faa-4aae-8787-3414530dbdd2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Magnesium Potassium Titanium Oxide,39290-90-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfb1a5f1-1c75-4931-a365-cbb4f23902fa/documents/IUC5-50cced93-74d9-4e20-8fe0-eaacff7ca5b4_bcefdf04-9faa-4aae-8787-3414530dbdd2.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,50 mg/m3,,rat Magnesium Potassium Titanium Oxide,39290-90-9,"Acute oral toxicity study with Terracess P (EC B.1, OECD 423): LD50 > 2000 mg/kg bw (rat).Acute dermal toxicty (OECD 402, non-GLP) study with Terracess P (OECD 402): LD50> 2000 mg/kg bw (rat)Acute inhalation study with Terracess P (OECD 403): LC50 > 5.04 mg/L air (rat). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfb1a5f1-1c75-4931-a365-cbb4f23902fa/documents/IUC5-ed798c45-3ceb-43b6-a398-09b82bab8865_bcefdf04-9faa-4aae-8787-3414530dbdd2.html,,,,,, Magnesium Potassium Titanium Oxide,39290-90-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfb1a5f1-1c75-4931-a365-cbb4f23902fa/documents/IUC5-ed798c45-3ceb-43b6-a398-09b82bab8865_bcefdf04-9faa-4aae-8787-3414530dbdd2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Magnesium Potassium Titanium Oxide,39290-90-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfb1a5f1-1c75-4931-a365-cbb4f23902fa/documents/IUC5-ed798c45-3ceb-43b6-a398-09b82bab8865_bcefdf04-9faa-4aae-8787-3414530dbdd2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Magnesium Potassium Titanium Oxide,39290-90-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfb1a5f1-1c75-4931-a365-cbb4f23902fa/documents/IUC5-ed798c45-3ceb-43b6-a398-09b82bab8865_bcefdf04-9faa-4aae-8787-3414530dbdd2.html,,inhalation,LC50,5.04 mg/m3,no adverse effect observed, magnesium sodium fluoride silicate,56450-90-9, The substance magnesium sodium fluoride silicate is non-toxic up to a concentration of > 2000 mg/kg bw after single oral administration. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b6a8348-a6bc-4576-b06c-faa9df670f6d/documents/368af542-0f35-4421-a813-82d339d7b3e7_1a57d76c-83a4-4b15-a52e-e181abbfc183.html,,,,,, Magnesium thiosulphate,10124-53-5," A 3-generation chronic toxicity study (Til et al. 1972a) with treatment of rats (20 per sex and group) with dose levels of 0, 0.125, 0.25, 0.5, 1.0 or 2.0% Na2S2O5 administered in a 50 ppm thiamine-containing diet was identified as most reliable study for repeated dose toxicity and was defined as key study (read-across info, see `discussion`). Based on the read across concept for the group of sulfite and thiosulfate substances, this result is also applicable to magnesium thiosulfate. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce2c4ad5-dcfd-4fac-ad2a-2bb76a782fa8/documents/06e7342f-4f4d-4640-9fec-16a33e004053_1aaee492-7f81-4641-9065-feaa17d71fd9.html,,,,,, Magnesium thiosulphate,10124-53-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce2c4ad5-dcfd-4fac-ad2a-2bb76a782fa8/documents/06e7342f-4f4d-4640-9fec-16a33e004053_1aaee492-7f81-4641-9065-feaa17d71fd9.html,Chronic toxicity – systemic effects,oral,NOAEL,155 mg/kg bw/day,,rat Magnesium thiosulphate,10124-53-5," Acute toxicity values (oral, dermal and inhalative) were determined for magnesium thiosulfate utilizing read-across data to sodium sulfite (CAS 7757-83-7), calcium thiosulfate (CAS 10124-41 -1) and potassium thiosulfate (CAS 10294-66-3). Please see `discussion` below. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce2c4ad5-dcfd-4fac-ad2a-2bb76a782fa8/documents/d74c5391-fac7-4353-bcc2-c9b01d973060_1aaee492-7f81-4641-9065-feaa17d71fd9.html,,,,,, "Magnesium, EDTA cobalt copper iron manganese zinc complexes",234446-82-3,"Structurally related source substances (EDTA-MnNa, EDTA-CuNa and EDTA-FeNa) ingredients of the target substance, showed no adverse effects relevant for classification after repeated oral administration. Therefore it is not justified to classify the target substance Magnesium, EDTA cobalt copper iron manganese zinc complexes (CAS 234446-82-3). ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2522eee-2e77-42d5-a823-53a60bf6197f/documents/IUC5-4e99a200-8ae7-4262-af93-094331c20773_2cbc0577-2d2d-420a-a057-7d2c68fb752b.html,,,,,, "Magnesium, EDTA cobalt copper iron manganese zinc complexes",234446-82-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2522eee-2e77-42d5-a823-53a60bf6197f/documents/IUC5-4e99a200-8ae7-4262-af93-094331c20773_2cbc0577-2d2d-420a-a057-7d2c68fb752b.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,150 mg/kg bw/day,,rat "Magnesium, EDTA cobalt copper iron manganese zinc complexes",234446-82-3,"Acute oral toxicity (rat): OECD No 401, LD50> 1740 mg/kg bw (BASF, 2000)Acute dermal toxicity (rat): OECD No 402 LD50>2000 mg/kg bw (Haferkorn, 2007)Acute inhalative toxicity (rat): OECD No 403, LC50 >5.1 mg/m3 (BASF, 2014) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2522eee-2e77-42d5-a823-53a60bf6197f/documents/IUC5-196d43f0-e7dd-4bac-8880-33cf44154f16_2cbc0577-2d2d-420a-a057-7d2c68fb752b.html,,,,,, "Magnesium, EDTA cobalt copper iron manganese zinc complexes",234446-82-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2522eee-2e77-42d5-a823-53a60bf6197f/documents/IUC5-196d43f0-e7dd-4bac-8880-33cf44154f16_2cbc0577-2d2d-420a-a057-7d2c68fb752b.html,,oral,discriminating dose,"1,740 mg/kg bw",no adverse effect observed, "Magnesium, EDTA cobalt copper iron manganese zinc complexes",234446-82-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2522eee-2e77-42d5-a823-53a60bf6197f/documents/IUC5-196d43f0-e7dd-4bac-8880-33cf44154f16_2cbc0577-2d2d-420a-a057-7d2c68fb752b.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Magnesium, EDTA cobalt copper iron manganese zinc complexes",234446-82-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2522eee-2e77-42d5-a823-53a60bf6197f/documents/IUC5-196d43f0-e7dd-4bac-8880-33cf44154f16_2cbc0577-2d2d-420a-a057-7d2c68fb752b.html,,inhalation,discriminating conc.,5.1 mg/m3,no adverse effect observed, Malic acid,6915-15-7,A 2 year chronic study in the rat with malic acid gave a NOEL of 5000 ppm (approximately 260 mg/kg/day). A 2 year chronic study in the rat with fumaric acid gave a NOAEL of approximately 600 mg/kg/day.Read across between malic acid and fumaric acid is considered valid as metabolism of fumaric acid to malic acid occurs as a key part of the Krebbs Cycle ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98f2d387-6152-4a27-89e5-7486a5627d63/documents/IUC5-424be290-3719-4427-9191-3e2f3c87dcef_7c2940ca-b3ba-4c1e-8774-33b366a53a57.html,,,,,, Malic acid,6915-15-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98f2d387-6152-4a27-89e5-7486a5627d63/documents/IUC5-424be290-3719-4427-9191-3e2f3c87dcef_7c2940ca-b3ba-4c1e-8774-33b366a53a57.html,Chronic toxicity – systemic effects,oral,NOAEL,260 mg/kg bw/day,,rat Malic acid,6915-15-7,Acute toxicity - Malic acid is conisdered to exhibit low acute toxicity and is widely used in food. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98f2d387-6152-4a27-89e5-7486a5627d63/documents/IUC5-41edb95e-0dc5-4692-b46a-4a1d16a45250_7c2940ca-b3ba-4c1e-8774-33b366a53a57.html,,,,,, Malic acid,6915-15-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98f2d387-6152-4a27-89e5-7486a5627d63/documents/IUC5-41edb95e-0dc5-4692-b46a-4a1d16a45250_7c2940ca-b3ba-4c1e-8774-33b366a53a57.html,,oral,LD50,"3,500 mg/kg bw",no adverse effect observed, Malic acid,6915-15-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98f2d387-6152-4a27-89e5-7486a5627d63/documents/IUC5-41edb95e-0dc5-4692-b46a-4a1d16a45250_7c2940ca-b3ba-4c1e-8774-33b366a53a57.html,,dermal,LD50,"20,000 mg/kg bw",no adverse effect observed, Malic acid,6915-15-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98f2d387-6152-4a27-89e5-7486a5627d63/documents/IUC5-41edb95e-0dc5-4692-b46a-4a1d16a45250_7c2940ca-b3ba-4c1e-8774-33b366a53a57.html,,inhalation,LC50,"1,306 mg/m3",no adverse effect observed, "Manganate(1-), glycinato-N,O)[sulfato(2-)-O]-, hydrogen",52139-31-8,"- 14-day DRF study conducted according to OECD test guideline 407, result: NOAEL = 1000 mg/kg bw/d. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfdc97ef-ceb9-446e-b3b7-ca0a1ed6c7de/documents/463a2afd-53b4-4a61-96eb-4d249b410490_6bcd6e3b-3618-4144-a0b7-0e4a3a1d58c4.html,,,,,, "Manganate(1-), glycinato-N,O)[sulfato(2-)-O]-, hydrogen",52139-31-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfdc97ef-ceb9-446e-b3b7-ca0a1ed6c7de/documents/463a2afd-53b4-4a61-96eb-4d249b410490_6bcd6e3b-3618-4144-a0b7-0e4a3a1d58c4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Manganate(1-), glycinato-N,O)[sulfato(2-)-O]-, hydrogen",52139-31-8,"One study according to OECD guideline 425 with the structurally similar Manganese monolysinate sulfate is available. Several studies investigated the effects of Manganese sulfate and glycine. Most of the data was gathered from studies that were performed prior to implementation of GLP and/or OECD guidelines. Only studies with sufficient documentation have been considered for a weight of evidence approach. Thus, the quality of the database is considered to be sufficient for classification.   - study conducted according to OECD test guideline 425 with manganese monolysinate, result: LD50> 2000 mg/kg bw, read-across - published data from Shibui et al., 2013, result: Glycine was administered to groups of 6 male and 6 female Crj: CD(SD) rats by oral gavage at dose levels of 500, 1000 and 2000 mg/kg bw/day for 28 days. All animals survived to study termination. No test substance-related findings were detected or observed in clinical examinations, body weights, food consumption values, clinical biochemistry and clinical pathology evaluations. During the anatomical pathology examinations, no test substance-related findings were observed or detected during macroscopic examinations, organ weight evaluations or microscopic examinations. There is no evidence for specific target organ toxicity in this study. The LD0 is 2000 mg/kg bw/day in this study. Read-across - published data from Yakuri et al., 1977, result:study similar to OECD 401, Oral LD50 (rat, females) 7930 mg/kg bw, Oral LD50 (rat, males) 9550 mg/kg bw, read-across - published data from NTP report 1993 with manganese sulfate, result: In a 14-days repeated dose toxicity study , fasted, 31 days old Fischer 344 strain rats were fed oral doses of MnSO4at 0, 3,130, 6,250, 12,500, 25,000, or 50,000 ppm in feed, 5 animals per group and were observed for 14 days. None of the animals died. No clinical signs were observed in the treated animals. No gross abnormalities in the internal organs were identified at the scheduled necropsy. Oral LOEL (rat, females/males) 50000 ppm, read-across published data from Singh and Junnarkar, 1991, result: In an acute oral toxicity study according to OECD guideline 401, 100-125 g weighing Wistar strain rats were given a single oral dose of MnSO4in deionized triple glass distilled water at increasing doses. LD50 with its fiducial limit was calculated using the method of Horn. Oral LD50 (rat, females/males) > 2150  mg/kg bw, read-across - published data from Smyth et al., 1969, result: In an acute oral toxicity study conducted similar to OECD guideline 401, groups of rats were given a single oral dose of Manganese acetate in water at doses between 2.68 and 5.21 g/kg bw and observed for occurring mortality. Oral LD50 Combined = 3730 mg/kg bw, read-across     ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfdc97ef-ceb9-446e-b3b7-ca0a1ed6c7de/documents/a6c58d70-e095-4b06-af5c-6313578281c7_6bcd6e3b-3618-4144-a0b7-0e4a3a1d58c4.html,,,,,, "Manganate(1-), glycinato-N,O)[sulfato(2-)-O]-, hydrogen",52139-31-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfdc97ef-ceb9-446e-b3b7-ca0a1ed6c7de/documents/a6c58d70-e095-4b06-af5c-6313578281c7_6bcd6e3b-3618-4144-a0b7-0e4a3a1d58c4.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Manganese,7439-96-5,"90-DAY REPEATED DOSE TOXICITY - INHALATION: NOAEL: 0.5 µg/L Mn Metal Powder, rat (male/female), Broich (2016).   In accordance with column 1 of Annex VIII of Regulation EC1907/2006 (specific information requirements), as noted in section 8.6.1, the route of exposure for repeated dose toxicity testing should be performed having regard to the most likely route of exposure. The dermal and inhalation routes were considered the most likely routes of exposure. As such, a 90-day repeated dose toxicity study that was conducted via the inhalation route is being relied upon to address the repeated dose toxicity information requirements. Since a 90-da inhalation study is available, it is not considered necessary to conduct a short-term study via any route.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6bc9500c-c0cf-41c4-98bc-9fc56ac4561e/documents/IUC5-f00bef17-4236-40b6-8d40-44dd76c4c406_aa606b32-ec54-4296-83c2-f2ba510ddf5a.html,,,,,, Manganese,7439-96-5,An acute oral study was conducted showing no toxicity. An acute inhalation study showed no toxicity. No dermal test was conducted on basis that dermal absorption unlikely. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6bc9500c-c0cf-41c4-98bc-9fc56ac4561e/documents/IUC5-347dc98e-8b13-49e8-be72-e48466752069_aa606b32-ec54-4296-83c2-f2ba510ddf5a.html,,,,,, Manganese,7439-96-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6bc9500c-c0cf-41c4-98bc-9fc56ac4561e/documents/IUC5-347dc98e-8b13-49e8-be72-e48466752069_aa606b32-ec54-4296-83c2-f2ba510ddf5a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Manganese,7439-96-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6bc9500c-c0cf-41c4-98bc-9fc56ac4561e/documents/IUC5-347dc98e-8b13-49e8-be72-e48466752069_aa606b32-ec54-4296-83c2-f2ba510ddf5a.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Manganese alumina pink corundum,68186-99-2,"It is concluded that the pigment was well tolerated and that no signs of systemic toxicity whatsoever were observed in rats when administered at a dose of 1000 mg/kg bw/day for up to 28 days. Either no or only marginal increases in Al and Mn plasma concentrations were observed, and only a minor fraction (<0.002%) of the total administered dose of Al and Mn was collected via urine, documenting the lack of bioavailability of this pigment. The no observed adverse effect level (NOAEL) in rats is 1000 mg/kg/day.   In a 90 -day repeated dose toxicity by inhalation study, rats were exposed via nose-only inhalation towards aerosol concentrations of 0.4, 1.5 and 6 mg/m³ of manganese alumina pink corundum. Two rats, one male and one female rat (low and intermediate concentration group) dropped out and had to be killed in moribund condition. These prescheduled deaths were considered to be incidental. All other animals survived the test period and were euthanized at scheduled dates. Effects indicating systemic toxicity were not observed. Sex-specific differences were not detected.The NOAEC was considered to be 6 mg/m³ (the concentration at or above the onset of lung overload, thus constituting the maximum tolerated concentration). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9597560-0e51-48c2-8448-81a48b85ff56/documents/IUC5-6257b96e-024f-4939-b279-6a9a00d848e7_b0714bff-8f6a-4979-8045-aaefd359eae0.html,,,,,, Manganese alumina pink corundum,68186-99-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9597560-0e51-48c2-8448-81a48b85ff56/documents/IUC5-6257b96e-024f-4939-b279-6a9a00d848e7_b0714bff-8f6a-4979-8045-aaefd359eae0.html,Repeated dose toxicity – local effects,inhalation,NOAEC,6 mg/m3,no adverse effect observed,rat Manganese alumina pink corundum,68186-99-2,"Acute oral lethal dose (LD 50): > 2200 mg/kg bw. Acute toxicity, inhalation: LC50 > 6.2 mg/L (MMAD: 1.8 µm (GSD: = 3.0)) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9597560-0e51-48c2-8448-81a48b85ff56/documents/IUC5-d8b5c0bd-bdc4-44df-b958-75767e2e776f_b0714bff-8f6a-4979-8045-aaefd359eae0.html,,,,,, Manganese antimony titanium buff rutile,68412-38-4,"Oral: RA: Antimony nickel titanium rutile 90d rat: NOAEL >500 mg/kg bw/d (OECD 408, Bomhard et al. 1982);  RA: Chrome antimony titanium buff rutile 90d rat: NOAEL >500 mg/kg bw/d (OECD 408, Bomhard et al. 1982) No indications of bioavailability for both substances (Bomhard et al. 1982) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e08fa3b-63cf-4ccb-81de-ee1decbf7b39/documents/58c45b00-48b6-4d5b-9f19-190edb47f3da_3d4bed70-112d-48df-82d0-cb1372484f06.html,,,,,, Manganese antimony titanium buff rutile,68412-38-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e08fa3b-63cf-4ccb-81de-ee1decbf7b39/documents/58c45b00-48b6-4d5b-9f19-190edb47f3da_3d4bed70-112d-48df-82d0-cb1372484f06.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Manganese antimony titanium buff rutile,68412-38-4,"oralLD50 rat > 5000 mg/kg bw (standardized test protocol; BASF 1985a, 1985 b); dermal not relevant inhalation LC50 > 2.199 mg/L for both sexes. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Two valid almost identical limit tests were available, which were both performed according to a standardized internal method which is in principle comparable to the OECD TG 401 but did not follow GLP requirements (BASF 1985a, 1985b). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The study cannot be used for classification based on the fact, that the Category 4 in the CLP Regulation (1272/2008) goes up to a concentration of 5 mg/L and not only up to the tested concentration. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e08fa3b-63cf-4ccb-81de-ee1decbf7b39/documents/f8f5e31b-fa6a-45b8-97aa-ada86533e3dd_3d4bed70-112d-48df-82d0-cb1372484f06.html,,,,,, Manganese antimony titanium buff rutile,68412-38-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e08fa3b-63cf-4ccb-81de-ee1decbf7b39/documents/f8f5e31b-fa6a-45b8-97aa-ada86533e3dd_3d4bed70-112d-48df-82d0-cb1372484f06.html,,inhalation,LC50,> 2.199 mg/L,no adverse effect observed, Manganese bis(dihydrogen phosphate),18718-07-5," A clear effect level cannot be determined from the studies. Please refer to SCOEL recommendations for occupational exposure limits. One reliability 2 study on an analogous substance is provided as both supporting and key data. This study covers 2 test species over chronic and sub-chronic time periods, according to an appropriate guideline and under GLP conditions. This study is therefore considered to be of high quality. Rationale for read-across The study was performed to assess the repeated dose toxicity and the carcinogenicity of manganese (as Mn2+). The substance tested (manganese(II)sulphate monohydrate) was chosen as the specific compound for testing due to stability, solubility, availability, and use of the sulphate as a food supplement for humans and animals. It is therefore considered that these data are reliable and justified for use in read-across to other Mn2+ containing compounds in which the manganese is considered to be the toxicologically relevant moiety. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a1034c8-5143-46fb-bf29-fe4749f353da/documents/IUC5-0d5079b0-06d8-4c47-89c8-d0485b6a65ec_09f2c65e-b40b-4c48-be80-c7a0ae8f4d30.html,,,,,, Manganese bis(dihydrogen phosphate),18718-07-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a1034c8-5143-46fb-bf29-fe4749f353da/documents/IUC5-0d5079b0-06d8-4c47-89c8-d0485b6a65ec_09f2c65e-b40b-4c48-be80-c7a0ae8f4d30.html,Chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Manganese bis(dihydrogen phosphate),18718-07-5,"One study exists: study is conducted to GLP and in compliance with agreed protocols, with no deviations from standard test guidelines (OECD 420) and no methodological deficiencies. The LD50 was found to be > 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a1034c8-5143-46fb-bf29-fe4749f353da/documents/IUC5-6bcae809-e249-4fbb-b6c8-70d32370120e_09f2c65e-b40b-4c48-be80-c7a0ae8f4d30.html,,,,,, Manganese bis(dihydrogen phosphate),18718-07-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a1034c8-5143-46fb-bf29-fe4749f353da/documents/IUC5-6bcae809-e249-4fbb-b6c8-70d32370120e_09f2c65e-b40b-4c48-be80-c7a0ae8f4d30.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Manganese bis(phosphinate),10043-84-2," Data available for the similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical manganese(2+) bis(phosphinate) (10043-84-2).The studies are as mentioned below: Study 1 In acute oral toxicity study, male Swiss strain Albino mice were treated with test material in dose concentration 2330mg/kg bw orally. The test material was dissolved in de-ionized triple glass distilled water. Each group consisted of 5 animals.50% mortality was observed in treated mouse at 2330 mg/kg bw. Behavioral changes like somnolence (general depressed activity) and convulsions or effect on seizure threshold were observed in treated mice. Therefore, LD50 was considered to be 2330mg/kg bw. When mouse were treated with test material orally.   Study 2 In acute oral toxicity study, male and female Wistar rats were treated with test material in dose concentration 2150mg/kg bw orally. The test material was dissolved in de-ionized triple glass distilled water. Each group consisted of 5 animals.50% mortality was observed in treated rats at 2150mg/kg bw. Behavioural changes like somnolence (general depressed activity) and convulsions or effect on seizure threshold were observed in treated rats .Therefore, LD50 was considered to be 2150mg/kg bw. When rats were treated with test material orally.   Study 3  In acute oral toxicity study, female Wistar rats were treated with test material in dose concentration 2000mg/kg bw orally according to OECD Test Guideline (TG) 420.No mortality was observed in treated rats at 2000 mg/kg bw. Therefore, LD50 was considered to be >2000 mg/kg bw. When rats were treated with test material orally Thus, based on the above summarised studies, manganese(2+) bis(phosphinate) (10043-84-2) and it’s read across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, manganese(2+) bis(phosphinate) (10043-84-2)cannot be classified for acute oral toxicity. Hence, based on the data available for the similar read across, test chemical manganese(2+) bis(phosphinate) (10043-84-2) is not likely to be toxic at least in the dose range of 2000-2330 mg/kg bw. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8794aae-f085-4383-8b8b-86b858cab02c/documents/81a1a2c4-f9b8-4919-937e-338a86861b92_14ca3f95-e740-4523-bcb8-f70b86af0da6.html,,,,,, Manganese bis(phosphinate),10043-84-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8794aae-f085-4383-8b8b-86b858cab02c/documents/81a1a2c4-f9b8-4919-937e-338a86861b92_14ca3f95-e740-4523-bcb8-f70b86af0da6.html,,oral,LD50,"2,330 mg/kg bw",no adverse effect observed, Manganese di(acetate),638-38-0,"The informations in the key study and both supporting studies were extracted from the NTP TECHNICAL REPORT 428 which includes each two 14 d, 13 w and 2 a repeated dose toxicity studies on mice and rats, which are peer-reviewed. These studies were performed equivalent to OECD guidelines 407, 408 and 453, are well-documented including raw data and are assessed to be of reliability 2, only because these studies were performed on the read-across substance MnSO4. By covering two species, three study durations and various observed endpoints, it can be concluded that all possible substance-related effects were detected. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2030de4-8f0d-4b2e-9378-b3b8b1479539/documents/07dc63db-2763-4627-b952-5843dd2f330b_e25d0fd8-4d8a-47ba-90e5-aaf0bc65d93d.html,,,,,, Manganese di(acetate),638-38-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2030de4-8f0d-4b2e-9378-b3b8b1479539/documents/07dc63db-2763-4627-b952-5843dd2f330b_e25d0fd8-4d8a-47ba-90e5-aaf0bc65d93d.html,Chronic toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,mouse Manganese di(acetate),638-38-0,"One study assessed with Klimisch 2 (Smyth, 1969) and two supporting studies (Singh, 1991 and Holbrook, 1975; both assess as Klimisch 4 since only abstracts are available) are available to cover the endpoint ""Acute Toxicity: oral"", hence, the available information meet fully the tonnage-driven data requirements of REACH. Additionally, all available studies revealed rather equivalent results, i.e. the LD50 of the key study (Smyth, 1969) is above the cut-off value of 2000 mg/kg bw for classification. In addition, the supprting study (Singh, 1991), when taking into account the correction for the molecular weight of Manganese acetate, the outcomes of the studies are consistent. Also, the results obtained by Holbrook, 1975 are rather close to the cut-off value, and as a consequence no classification is needed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2030de4-8f0d-4b2e-9378-b3b8b1479539/documents/086162c8-914e-4d90-8285-d23fa98d6b45_e25d0fd8-4d8a-47ba-90e5-aaf0bc65d93d.html,,,,,, Manganese di(acetate),638-38-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2030de4-8f0d-4b2e-9378-b3b8b1479539/documents/086162c8-914e-4d90-8285-d23fa98d6b45_e25d0fd8-4d8a-47ba-90e5-aaf0bc65d93d.html,,oral,LD50,"3,730 mg/kg bw",no adverse effect observed, Manganese dinitrate,10377-66-9," Please refer to the RAAF report attached to section 13 of this dataset which discusses the cateogory approach for sharing of data between the three soluble manganese salts Mn chloride, Mn nitrate and Mn sulphate. There is a body of publicly available literature data on repeated application of MnCl2 however, these data are not conducted according to standardised test guidelines or the principles of GLP and are of varying quality and reliability.  Whilst the literature for repeated dose toxicity of MnCl2 shows a variety of effects on repeated application of MnCl2, these studies are not consistent in their dosing methods, duration, or with the species of test animals that are used.  As a consequence of this, the results are variable and not aligned with observations from more reliable studies conducted to standardised international guidelines and GLP.  Therefore the effects observed in the reproductive and developmental toxicity studies on MnCl2 via the inhalation route are given more weight than the lower reliability literature references and are considered to be the better indicator of the long term toxicological effects of this substance via the inhalation route rather than the older literature data. In the reproductive toxicity study by Grieve (2017) subsequently published by McGough & Jardine (2016) clinical signs of reaction to treatment to inhalation exposure of MnCl2 were confined to a few animals with wheezing respiration in the F0 generation exposed to 10 and 20 μg/L.  At 20 μg/L, overall body weights and food consumption of the F0 males throughout the study were lower than controls.  At target 10 and 20 μg/L, there was a statistically significant increase in kidney weights compared to the controls, however there was no alteration in the normal structure of these organs.  In all treated F0 females, there was a statistically significant increase in lung weights compared to the controls which was not evident in the F1 females.  The NOEL for adult effects was not established due to effects on the respiratory tract.  However, the respiratory tract effects observed are commonly observed in irritant materials and were considered not to be a unique effect of MnCl2 and therefore, when the local irritant effects are disregarded, the parental NOAEL was considered to be 20 μg/L (Grieve, 2017). In the developmental toxicity study (Dettwiler, 2015) conducted in accordance with OECD Guideline 414, treatment with MnCl2 caused breathing noises in eight females in exposed to 15 μg/L air and eighteen females exposed to 25 μg/L air.  Treatment caused a dose dependent reduction in food consumption in groups exposed to 15 μg/L air and 25 μg/L air. This reduction was statistically significant during the most of the study and was accompanied by reduced body weights, reduced body weight gain during the study and reduced corrected body weight gain at termination at both dose levels and therefore effect on food consumption was considered to be adverse.  Histopathology examination performed on the lungs from six selected pregnant females per group revealed lesions with a dose dependent frequency and severity in groups exposed to 15 μg/L and 25 μg/L.  The macroscopically identified foci in two females in groups exposed to 25 μg/L were correlated to alveolar haemorrhage or phagocytic alveolar macrophage foci. Based on these results, the NOAEL as well as the NOEL for the toxicity in pregnant females were considered to be 5 μg/L air.  In non-pregnant females, the NOEL for systemic toxicity was established at 15 μg/L air, whereas the NOAEL was established at 25 μg/L air.  These observations are consistent with a number of literature references indicating a loss of body weight during administration of MnCl2 and a developmental neurotoxicity study which also noted this loss and a dose-dependent reduction in food consumption (Dettwiler, 2016). The repeated dose studies on MnSO4 were from the US National Toxicology Program technical report on the toxicology and carcinogenesis of manganese(II) sulphate monohydrate in F344/N rats and B6C3F1 mice (feed studies) (NTP, 1993).  The studies were not conducted to then-standardised guidelines but to peer reviewed methods as specified by the NTP and as such are considered wholly reliable. The high level of MnSO4 consumed by rats on a daily basis for 13 weeks in this study, without mortality, supports the lack of acute toxicity.  In the two-year study survival of male rats exposed to 15 000 ppm was significantly lower than that of the controls attributed to increased incidences of advanced renal disease relating to the ingestion of MnSO4. The final mean bodyweight of male rats exposed to 15 000 ppm was 10 % lower than that of the controls. The mean body weights of all the other exposed groups were similar to the controls (NTP, 1993).  At both the 9- and 15-month interim evaluations, tissue concentrations of manganese were significantly elevated in the livers of male and female rats exposed to 5 000 and 15 000 ppm, with an accompanying depression of hepatic iron.  The ingestion of diets containing 15 000 ppm MnSO4 was associated with a marginal increase in the average severity of nephropathy in male rats. In these rats, lesions associated with renal failure, uraemia, and secondary hyperparathyroidism were observed.  No increased incidence of neoplasms in male or female rats was attributed to ingestion of MnSO4.  There was no evidence of carcinogenic activity of manganese sulphate monohydrate in male or female F344/N rats (NTP, 1993). In mice, no clinical findings were attributed to manganese sulphate ingestion at 13 weeks (NTP, 1993).  Concentrations of manganese were significantly elevated in the livers of mice exposed to 5 000 and 15 000 ppm at the 9 and 15 month evaluations. It was uncertain if the slightly increased incidence of follicular cell adenoma is related to the ingestion of MnSO4. The study suggests equivocal evidence of carcinogenicity in male and female mice. Based on marginally increased incidences of thyroid gland follicular cell adenoma and significantly increased incidences of follicular cell hyperplasia (NTP, 1993). There are no data available on manganese dinitrate itself. As stated above, given that the toxicity of the soluble manganese salts is generally accepted to be attributed to the Mn2+ ion it is proposed to use read across to maximise the use of the available data. The lack of GLP, guideline studies performed on MnCl2 to specifically investigate the repeated dose effects warrants the application of the information generated in the reproductive and developmental  toxicity studies on this substance.  These studies are conducted under GLP conditions to modern standardised guidelines and are considered to provide adequate information with regards to the long term effects of the substance via the inhalation route.  Similarly it is considered appropriate to use these same studies as the source of data to address the repeated dose toxicity of MnSO4 via the  inhalation route as no data are available on the toxicity of the sulphate via this route  of exposure. The repeated dose toxicity studies conducted on MnSO4 in support of the NTP programme are well conducted and reliable studies and are considered to be the most appropriate source of data on the long term effects of exposure to the Mn2+ ion via the oral route.  As such it is considered appropriate to use these studies to support this endpoint in both the MnSO4 dossier and as read across in the MnCl2 dossier.  These studies on MnSO4 via the oral route do not result in the classification of the substance and in conjunction with studies via the inhalation route conducted on MnCL2 are considered to represent the “worst case scenario” in relation to the effects of long term exposure to soluble manganese salts. No repeated dose toxicity studies are available on Mn(NO3)2 manganese dinitrate  and read-across is proposed for these endpoints. As described above, given that the toxicity of the soluble manganese salts is generally accepted to be attributed to the Mn2+ ion in conjunction with the lack of any modern studies performed on Mn(NO3)2 , it is considered appropriate to utilise read-across to the key studies performed on MnCl2 (inhalation exposure) and MnSO4 ( Oral exposure). Furthermore, it is considered that these guideline studies can be considered to give an accurate representation of the toxicity of the Mn2+ ion in Mn(NO3)2 and should therefore be considered adequate to address these endpoints. These studies via the oral route (MnSO4) do not result in the classification of the substance and as such the studies via the inhalation route as conducted on MnCL2 are considered to represent the “worst case scenario” in relation to the effects of long term exposure to soluble manganese salts. Read-across between the three salts is considered to be justified based on the high water solubility and ultimate identical physiological fate all three salts share once the anions disassociate into the respective endogenous physiological pools.  In the case of both MnCl2 and MnSO4, evidence suggests that repeated dosing triggers a strong homeostatic response which reduces the toxicity by presumably increasing excretion/decreasing absorption (Vrcic and Kello, 1988).  This can be taken as further evidence that read-across between these three soluble manganese salts  is justified. Toxicokinetic and toxicity data confirm  that the manganese cations are the driving factor for any human health effects observed.  The respective anions, chloride (Cl-), sulphate (SO42-) and nitrate (NO3 ), are readily absorbed and excreted from the human body, and their contribution on toxicological effects is not considered significant. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6093ddcb-3cfd-40d3-8234-41c2c4285019/documents/IUC5-a4a033b5-f67e-4f69-95a7-9701eb5f39bf_8109d347-fb16-409b-8ce6-ae14005660a0.html,,,,,, Manganese ferrite black spinel,68186-94-7,"for Fe3O4 as representative source substances for the iron oxide category members are available.Additionally, a short-term (5-day) inhalation study with two different grades of nanomaterials was conducted. Rats were exposed to 10 and 30 mg/m³ of smaller nano-sized Fe2O3 and 30 mg/m³ of larger nano-sized Fe2O3. Sub-chronic repeated dose toxicity studies with Fe3O4, Fe2O3 and FeOOH as representative source substances for the iron oxide category members are available. A NOAEL of greater than 1000 mg/kg bw/day is derived for all three substances, based on a complete absence of adverse effects. For repeated dose toxicity via the dermal route, no reliable studies are available for the iron oxide category. Details on the category justification are given in the read-across document attached in IUCLID section 13.2. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e47f142-4eaa-4904-8d4d-6b8d4eee894d/documents/IUC5-5fd1f0d1-1976-48da-89f5-ccf0cb9845ba_12374c32-5050-47a5-888e-a667cc4f35e9.html,,,,,, Manganese ferrite black spinel,68186-94-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e47f142-4eaa-4904-8d4d-6b8d4eee894d/documents/IUC5-5fd1f0d1-1976-48da-89f5-ccf0cb9845ba_12374c32-5050-47a5-888e-a667cc4f35e9.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4.7 mg/m3,adverse effect observed,rat Manganese ferrite black spinel,68186-94-7,In an oral acute toxicity study 10 animals were treated with 10000 mg/kg bw manganese ferrite black spinel. During an observation time of 14 days none of the animals showed signs of toxicity or died. In an acute inhalation toxicity study with Fe2O3 as a surrogate for the iron oxide group the discriminating dose was 5050 mg/m³. No study for acute dermal toxicity is available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e47f142-4eaa-4904-8d4d-6b8d4eee894d/documents/IUC5-40f4f01d-c035-41e5-bda0-f6830f711bd7_12374c32-5050-47a5-888e-a667cc4f35e9.html,,,,,, Manganese ferrite black spinel,68186-94-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e47f142-4eaa-4904-8d4d-6b8d4eee894d/documents/IUC5-40f4f01d-c035-41e5-bda0-f6830f711bd7_12374c32-5050-47a5-888e-a667cc4f35e9.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, Manganese ferrite black spinel,68186-94-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e47f142-4eaa-4904-8d4d-6b8d4eee894d/documents/IUC5-40f4f01d-c035-41e5-bda0-f6830f711bd7_12374c32-5050-47a5-888e-a667cc4f35e9.html,,inhalation,discriminating conc.,"5,050 mg/m3",no adverse effect observed, Manganese neodecanoate,27253-32-3,"No repeated dose toxicity study with manganese neodecanoate is available, thus the repeated dose toxicity will be addressed with existing data on the individual moieties manganese and neodecanoate. In relevant and reliable oral repeated dose toxicity studies as well as supporting studies for both moieties of manganese neodecanoate, there were no toxicological findings reported. However, due to adverse effects observed in long-term inhalation studies and considering the read-across principles for manganese neodecanoate based on the toxicological assessment of the individual moieties, it is therefore proposed to also read-across the classification of Specific target organ toxicity-repeated exposure, category 2 based on neurological effects (H373- brain, inhalation) of manganese sulphate. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0130c534-0d9a-497f-8460-a2df4fb99270/documents/107226df-9f3d-4459-b566-249937e2d77b_d800003b-5cae-400e-bda5-18fe36645804.html,,,,,, Manganese neodecanoate,27253-32-3,"In a GLP conform OECD 423 study, the acute oral LD50 value of the test item manganese neodecanoate was found to be between 300 and 2000 mg/kg bw in female Han:WIST rats.  No acute dermal toxicity study with manganese neodecanoate is available, thus the acute dermal toxicity will be addressed with existing data on the dissociation products manganese and neodecanoic acid. Signs of acute dermal toxicity are not expected for manganese neodecanoate, since the two moieties manganese and neodecanoic acid have not shown signs of acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0130c534-0d9a-497f-8460-a2df4fb99270/documents/28aea558-6c82-49e5-834f-d5ed229b7119_d800003b-5cae-400e-bda5-18fe36645804.html,,,,,, Manganese neodecanoate,27253-32-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0130c534-0d9a-497f-8460-a2df4fb99270/documents/28aea558-6c82-49e5-834f-d5ed229b7119_d800003b-5cae-400e-bda5-18fe36645804.html,,oral,LD50,ca.500 mg/kg bw,adverse effect observed, Manganese oxide,1344-43-0," There is a paucity of animal test data for MnO. However, information from mice studies on MnCO3  have been used to read across oral results from a sub-chronic (Komura et al 1991) and chronic (Komura et al 1992)  time periods and these show relatively mild effects given the high dietary dose.  Given that mice tend to be generally more sensitive than rats, these oral results do not cause concern for that route of exposure. The basis for the read across is justified by similarities between MnO and MnCO3; same oxidation state (+II), both are very poorly soluble in water (IUCLID section 4.8) and have similar leaching values in simulated gastric juice (IUCLID section 8.6.4 ). Both are not acutely toxic by the oral route (IUCLID section 7.2.1) No relevant  inhalation studies are available. No relevant dermal studies are available. Repeated Dose Oral Toxicity: Read-Across From NTP (1993) Under the conditions of the study the NOAEL was 1 700 mg/kg bw for males and 2 000 mg/kg bw for females.   Repeated Dose Inhalation Toxicity: Read-Across From Camner (1985) Under the conditions of the study the LOAEC was 3.9 mg/m3 based on an increase in the size of alveolar macrophages in the high-dose group.   Repeated Dose Dermal Toxicity A short-term toxicity study via the dermal route does not need to be conducted as the physiological properties of the substance do not suggest a significant rate of absorption through the skin and no systemic effects or other evidence of absorption were seen in the skin or eye irritation studies (IUCLID section 7.3) and furthermore the water solubility of the substance is very poor (IUCLID section 4.8), and therefore a  limited amount of potential substance is available for systemic absorption via the dermal route. Therefore in accordance with Annex XI, section 1.1, this test is not considered necessary. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09b4cba9-9ecd-4b31-8b85-4f414af6240f/documents/IUC5-383726cf-2c1e-4b3e-9441-dd0ea50854a7_d9f2cbf8-de75-4e02-b13d-76bc35d5b618.html,,,,,, Manganese oxide,1344-43-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09b4cba9-9ecd-4b31-8b85-4f414af6240f/documents/IUC5-383726cf-2c1e-4b3e-9441-dd0ea50854a7_d9f2cbf8-de75-4e02-b13d-76bc35d5b618.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,700 mg/kg bw/day",,rat Manganese oxide,1344-43-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09b4cba9-9ecd-4b31-8b85-4f414af6240f/documents/IUC5-383726cf-2c1e-4b3e-9441-dd0ea50854a7_d9f2cbf8-de75-4e02-b13d-76bc35d5b618.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,3.9 mg/m3,,rabbit Manganese oxide,1344-43-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09b4cba9-9ecd-4b31-8b85-4f414af6240f/documents/IUC5-383726cf-2c1e-4b3e-9441-dd0ea50854a7_d9f2cbf8-de75-4e02-b13d-76bc35d5b618.html,Repeated dose toxicity – local effects,inhalation,LOAEC,3.9 mg/m3,adverse effect observed,rabbit Manganese oxide,1344-43-0," An acute oral study was conducted showing no toxicity. An acute inhalation study showed no toxicity. No dermal test was conducted on basis that dermal absorption unlikely. Acute Oral Toxicity: Pooles (2009) The acute oral median lethal dose (LD50) of the test material in the female Wistar rat was determined to be greater than 2000 mg/kg bw under the conditions of the test. Acute Inhalation Toxicity: Griffiths (2010) No deaths occurred in a group of ten rats exposed to a mean achieved atmosphere concentration of 5.35 mg/L for four hours. It was therefore considered that the acute inhalation median lethal concentration (4 hr LC50) of MnS, in the HsdHan:WIST stain rat, was greater than 5.34 mg/L. Acute Dermal Toxicity The physiochemical properties of MnO suggest it is unlikely to be absorbed through the skin. It has very poor water solubility and inorganic ions do not pass easily through the dermal barrier. In addition, MnO is not acutely toxic by the oral route and therefore it is highly unlikely that it would be toxic via the dermal route which in general absorbs chemicals to a much lesser degree than the gastrointestinal tract. Therefore in accordance with Annex VIII, section 8.5.3 column 2 adaptation, this test is not considered scientifically justified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09b4cba9-9ecd-4b31-8b85-4f414af6240f/documents/IUC5-6ac60bd1-eb1b-4997-a286-d28935146ff6_d9f2cbf8-de75-4e02-b13d-76bc35d5b618.html,,,,,, Manganese oxide,1344-43-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09b4cba9-9ecd-4b31-8b85-4f414af6240f/documents/IUC5-6ac60bd1-eb1b-4997-a286-d28935146ff6_d9f2cbf8-de75-4e02-b13d-76bc35d5b618.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Manganese oxide,1344-43-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09b4cba9-9ecd-4b31-8b85-4f414af6240f/documents/IUC5-6ac60bd1-eb1b-4997-a286-d28935146ff6_d9f2cbf8-de75-4e02-b13d-76bc35d5b618.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Manganese sulphide,18820-29-6,"REPEATED DOSE ORAL TOXICITYSupporting Study on Read Across Substance MnSO4 (NTP, 1993)Under the conditions of the study the NOAEL was 1 700 mg/kg bw for males and 2 000 mg/kg bw for females.   REPEATED DOSE INHALATION TOXICITYSupporting Study on Read Across Substance MnCl2 (Grieve, 2017)Under the conditions of this study, the No Observed Effect Level was considered to be the target dose level 20 μg/L. Supporting Study on Read Across Substance MnCl2 (Camner, 1985)Under the conditions of the study, no abnormalities were found in Mn(II) exposed animals, except for an increase in the size of alveolar macrophages in the high-dose group. Supporting Study on Read Across Substance MnSO4 (Dorman, 2006)MnSO4 inhalation affected the haematology and resulted in increased Mn concentrations in the brain of the monkey. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7d0f6ca-da9d-496f-a88f-418cf82b3153/documents/IUC5-00f9f4fa-7568-43a8-b84b-62bb2971ab79_5078c9a6-3faa-41e5-ac8f-82678c040f92.html,,,,,, Manganese sulphide,18820-29-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7d0f6ca-da9d-496f-a88f-418cf82b3153/documents/IUC5-00f9f4fa-7568-43a8-b84b-62bb2971ab79_5078c9a6-3faa-41e5-ac8f-82678c040f92.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,700 mg/kg bw/day",,rat Manganese sulphide,18820-29-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7d0f6ca-da9d-496f-a88f-418cf82b3153/documents/IUC5-00f9f4fa-7568-43a8-b84b-62bb2971ab79_5078c9a6-3faa-41e5-ac8f-82678c040f92.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,3.9 mg/m3,,rabbit Manganese sulphide,18820-29-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7d0f6ca-da9d-496f-a88f-418cf82b3153/documents/IUC5-00f9f4fa-7568-43a8-b84b-62bb2971ab79_5078c9a6-3faa-41e5-ac8f-82678c040f92.html,Repeated dose toxicity – local effects,inhalation,LOAEC,3.9 mg/m3,adverse effect observed, Manganese sulphide,18820-29-6,"Acute Oral Toxicity: Under the conditions of the study the acute oral LD50 was > 2 000 mg/kg bw.   Acute Inhalation Toxicity: Under the conditions of the study the acute inhalation LC50 was > 5.34 mg/L.   Acute Dermal Toxicity: MnS is not acutely toxic by the oral route (IUCLID ref: section 7.2.1). Due to its very low water solubility (IUCLID ref: section 4.8), dermal absorption is expected to be negligible.  Based  on the information on oral toxicity and the phys-chem properties of the substance – from a scientific evaluation, testing is not scientifically necessary in accordance with Annex XI  section 1.1. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7d0f6ca-da9d-496f-a88f-418cf82b3153/documents/IUC5-090be9bb-2c29-4645-8b43-ec6aa78194ed_5078c9a6-3faa-41e5-ac8f-82678c040f92.html,,,,,, Manganese sulphide,18820-29-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7d0f6ca-da9d-496f-a88f-418cf82b3153/documents/IUC5-090be9bb-2c29-4645-8b43-ec6aa78194ed_5078c9a6-3faa-41e5-ac8f-82678c040f92.html,,oral,LD50,"> 2,000 mg/kg bw",adverse effect observed, Manganese sulphide,18820-29-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7d0f6ca-da9d-496f-a88f-418cf82b3153/documents/IUC5-090be9bb-2c29-4645-8b43-ec6aa78194ed_5078c9a6-3faa-41e5-ac8f-82678c040f92.html,,inhalation,LC50,> 5.34 mg/L,no adverse effect observed, "[[2,2',2''-[Nitrilotris[2,1-ethanediyl(nitrilo-kN)methylidyne]]tris[phenolato-kO]](3-)]manganese",61007-89-4,"28-day study: oral NOAEL = 150 mg/kg bw/day (RCC, 2003) ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ebadd97-1092-480c-a55a-3906a8d56b4a/documents/IUC5-f02fbe48-dd0a-4b8d-8d95-16812e1e9f8e_b433d845-3e7b-4f8d-893d-d94ef9f337cc.html,,,,,, "[[2,2',2''-[Nitrilotris[2,1-ethanediyl(nitrilo-kN)methylidyne]]tris[phenolato-kO]](3-)]manganese",61007-89-4,"LD50(oral) > 2000 mg/kg (RCC, 2002)LD50(dermal) > 2000 mg/kg (RCC, 2002) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ebadd97-1092-480c-a55a-3906a8d56b4a/documents/IUC5-299fa84d-848e-4438-bde0-fff7cd156533_b433d845-3e7b-4f8d-893d-d94ef9f337cc.html,,,,,, "Manganese, 3-hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-2-naphthalenecarboxylic acid complex",35355-77-2,"- Acute oral toxicity: In a study (1973) similar to OECD TG 401, non-GLP, the LD50 was determined to be greater than 6000 mg/kg bw in rats. Responses to the administered test substance were negligible. No death occured at any dosage levels used. - Acute inhalative toxicity: No study was performed with the test item. Reliable experimental data from an analogue substances are available. Based on the absence of mortality in a study (2018) according to OECD TG 403 and GLP, the LC50 was determined to be greater than 5 mg/L in male and female rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Study was conducted similar to OECD TG 401, non-GLP, Klimisch 2. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Study was conducted according to OECD TG 403, GLP, Klimisch 1. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37314931-fac4-4e92-bd54-06106ababbf2/documents/IUC5-dcf73408-8bec-4336-aecc-01f74b89c4c7_88827ffb-55e4-49d8-95fe-8a5756cafcb3.html,,,,,, "Manganese, 3-hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-2-naphthalenecarboxylic acid complex",35355-77-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37314931-fac4-4e92-bd54-06106ababbf2/documents/IUC5-dcf73408-8bec-4336-aecc-01f74b89c4c7_88827ffb-55e4-49d8-95fe-8a5756cafcb3.html,,oral,discriminating dose,"6,000 mg/kg bw",no adverse effect observed, "Manganese, 3-hydroxy-4-[(1-sulfo-2-naphthalenyl)azo]-2-naphthalenecarboxylic acid complex",35355-77-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37314931-fac4-4e92-bd54-06106ababbf2/documents/IUC5-dcf73408-8bec-4336-aecc-01f74b89c4c7_88827ffb-55e4-49d8-95fe-8a5756cafcb3.html,,inhalation,discriminating conc.,5 mg/L,no adverse effect observed, "Manganese, 4-[(4-chloro-5-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex",12238-31-2," The NOAEL for chronic oral toxicity is established at 25 mg/kg bw based on repeated dose toxicity studies with analogue substances. Higher doses result in kidney damage. This is derived from subacute gavage studies with Pigment Red 57:1(Ca) (OECD 422, GLP, MHLW 1993), Pigment Red 48:2(Ca) (OECD 422, GLP, MHLW 2009) and Pigment Red 57(Sr) (OECD 407, GLP, DIC 2006). No histopathology findings on kidneys were reported after a two-year skin painting study with mice with Pigment Red 57:1(Ca) (Carson 1984). Regarding the cation, available data indicate that the limit values derived by the SCOEL are lower than those calculated for the kidney effects of the organic part and will therefore be used for protection to the pigment. The amine that would be liberated from azo reduction caused adverse effects upon subacute oral toxicity at a dose of 1000 mg/kg bw. The NOAEL was set at 300 mg/kg bw/day for both sexes. (ECHA disseminated dossier). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54eca553-ed56-4172-aea7-4e5f3de13af9/documents/IUC5-45e64333-ea35-458a-af40-b7e3d93b6300_97f127af-a2d0-451d-b9ac-b7920f253f23.html,,,,,, "Manganese, 4-[(4-chloro-5-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex",12238-31-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54eca553-ed56-4172-aea7-4e5f3de13af9/documents/IUC5-45e64333-ea35-458a-af40-b7e3d93b6300_97f127af-a2d0-451d-b9ac-b7920f253f23.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat "Manganese, 4-[(4-chloro-5-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex",12238-31-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54eca553-ed56-4172-aea7-4e5f3de13af9/documents/IUC5-45e64333-ea35-458a-af40-b7e3d93b6300_97f127af-a2d0-451d-b9ac-b7920f253f23.html,Chronic toxicity – systemic effects,dermal,NOAEL,50 mg/kg bw/day,,mouse "Manganese, 4-[(4-chloro-5-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex",12238-31-2," Studies with members of the same category indicate that Pigment 52:2 is not acutely toxic via the oral, inhalation, and dermal route of exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54eca553-ed56-4172-aea7-4e5f3de13af9/documents/IUC5-584be3ed-d3f9-470d-845a-5919b3545b30_97f127af-a2d0-451d-b9ac-b7920f253f23.html,,,,,, "Manganese, 4-[(4-chloro-5-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex",12238-31-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54eca553-ed56-4172-aea7-4e5f3de13af9/documents/IUC5-584be3ed-d3f9-470d-845a-5919b3545b30_97f127af-a2d0-451d-b9ac-b7920f253f23.html,,oral,LD50,"6,400 mg/kg bw",no adverse effect observed, "Manganese, 4-[(4-chloro-5-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex",12238-31-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54eca553-ed56-4172-aea7-4e5f3de13af9/documents/IUC5-584be3ed-d3f9-470d-845a-5919b3545b30_97f127af-a2d0-451d-b9ac-b7920f253f23.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, "Manganese, 4-[(4-chloro-5-methyl-2-sulfophenyl)azo]-3-hydroxy-2-naphthalenecarboxylic acid complex",12238-31-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54eca553-ed56-4172-aea7-4e5f3de13af9/documents/IUC5-584be3ed-d3f9-470d-845a-5919b3545b30_97f127af-a2d0-451d-b9ac-b7920f253f23.html,,inhalation,LC50,"1,518 mg/m3",no adverse effect observed, "Mannanase, endo-1,4-β-",37288-54-3," The repeated dose oral toxicity of Mannanase has been tested by oral gavage in Han Wistar rats. Dosing of the animals at doses up to 100% of the Mannanase, batch PPE42634 (equivalent to 1277 mg enzyme concentrate dry matter/kg bw/day) for 13 weeks was well-tolerated and there was no significant finding of any toxicological relevance. The no-observed-adverse-effect level (NOAEL) in this study was considered to be 100% Mannanase, batch PPE42634 equivalent to 1277 mg enzyme concentrate dry matter/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48170f9e-254d-4abf-8755-5e22dba14eeb/documents/IUC5-7d36d99a-2c14-42f2-8cda-7540f28eb0c7_a42444de-ec41-4207-8023-c01c995663d1.html,,,,,, "Mannanase, endo-1,4-β-",37288-54-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48170f9e-254d-4abf-8755-5e22dba14eeb/documents/IUC5-7d36d99a-2c14-42f2-8cda-7540f28eb0c7_a42444de-ec41-4207-8023-c01c995663d1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,277 mg/kg bw/day",,rat "Mannanase, endo-1,4-β-",37288-54-3," The acute oral and acute inhalation toxicity of mannanase has been tested. Both studies were short-term toxicity tests conducted according to OECD guidelines and in compliance with GLP. No acute dermal toxicity test was conducted. The conclusion was that mannanase is non-toxic by acute oral or inhalation exposure. Based on weight of evidence, mannanase does not exert any acute dermal toxicity under foreseeable realistic exposures for either workers or consumers. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48170f9e-254d-4abf-8755-5e22dba14eeb/documents/IUC5-5957f3a1-8239-4218-b019-34ab0e030322_a42444de-ec41-4207-8023-c01c995663d1.html,,,,,, "Mannanase, endo-1,4-β-",37288-54-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48170f9e-254d-4abf-8755-5e22dba14eeb/documents/IUC5-5957f3a1-8239-4218-b019-34ab0e030322_a42444de-ec41-4207-8023-c01c995663d1.html,,oral,,"3,320 mg/kg bw",no adverse effect observed, "Mannanase, endo-1,4-β-",37288-54-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48170f9e-254d-4abf-8755-5e22dba14eeb/documents/IUC5-5957f3a1-8239-4218-b019-34ab0e030322_a42444de-ec41-4207-8023-c01c995663d1.html,,inhalation,,450 mg/m3,no adverse effect observed, "Matte, copper",67711-91-5,- complex metal containing substance - solubility of metal constituents is poor - bio-accessibility in gastric fluids and sweat - particle size distribution and relevance of “respirable fraction” - classification via mixture toxicity rules ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8b1da9f-b220-40df-a6df-ee8527be8af1/documents/dc9e6cc2-096e-4839-9437-4cf5fd09a753_88dc7bd2-d635-4527-a3cd-8a87ad1e85a1.html,,,,,, "Matte, copper",67711-91-5,"- complex metal containing substance. - water solubility of the substance is poor (for metal constituents) - oral and dermal bio-accessibility - particle size distribution and potential for inhalation toxicity of molten liquid, solid massive and/or solid powder - classification based on mixture toxicity rules ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8b1da9f-b220-40df-a6df-ee8527be8af1/documents/3352b294-9cc5-4fda-86fb-2279217febf0_88dc7bd2-d635-4527-a3cd-8a87ad1e85a1.html,,,,,, m-bis(1-methylvinyl)benzene,3748-13-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Adequate Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Adequate ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2314047a-7a7b-4faa-8d47-ab25d4ae9d28/documents/e061b6a6-de69-49cd-96ad-78b746fe64d0_02444d8c-03d8-475e-824a-0e99134abe03.html,,,,,, m-bis(1-methylvinyl)benzene,3748-13-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2314047a-7a7b-4faa-8d47-ab25d4ae9d28/documents/e061b6a6-de69-49cd-96ad-78b746fe64d0_02444d8c-03d8-475e-824a-0e99134abe03.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat m-bis(1-methylvinyl)benzene,3748-13-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2314047a-7a7b-4faa-8d47-ab25d4ae9d28/documents/e061b6a6-de69-49cd-96ad-78b746fe64d0_02444d8c-03d8-475e-824a-0e99134abe03.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,500 mg/m3,,rat m-bis(1-methylvinyl)benzene,3748-13-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Adequate Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Adequate. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Adequate ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2314047a-7a7b-4faa-8d47-ab25d4ae9d28/documents/29e500ed-ec23-46bd-be39-80e816eb8dd7_02444d8c-03d8-475e-824a-0e99134abe03.html,,,,,, m-bis(1-methylvinyl)benzene,3748-13-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2314047a-7a7b-4faa-8d47-ab25d4ae9d28/documents/29e500ed-ec23-46bd-be39-80e816eb8dd7_02444d8c-03d8-475e-824a-0e99134abe03.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, m-bis(1-methylvinyl)benzene,3748-13-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2314047a-7a7b-4faa-8d47-ab25d4ae9d28/documents/29e500ed-ec23-46bd-be39-80e816eb8dd7_02444d8c-03d8-475e-824a-0e99134abe03.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, m-bis(1-methylvinyl)benzene,3748-13-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2314047a-7a7b-4faa-8d47-ab25d4ae9d28/documents/29e500ed-ec23-46bd-be39-80e816eb8dd7_02444d8c-03d8-475e-824a-0e99134abe03.html,,inhalation,LC50,5.6 mg/m3,adverse effect observed, Mecoprop,7085-19-0," 7 -Week Range Finding Study: Kirsch et al. (1986).  Under the conditions of the study, the no effect level is between 50 and 400 ppm..   4-Week Range Finding Study: Schilling (1990a).  Under the conditions of the study the ""no adverse effect level"" for male and female mice is between 900 ppm (~ 220 mg/kg body weight) and 2 700 ppm (~ 890 mg/kg body weight). 4-Week Range Finding Study: Schilling (1990b).  Under the conditions of the sudy the ""no adverse effect level"" for male and female mice could not be determined but was estimated to be < 2 700 ppm.   Sub-Chronic Repeated Dose Toxicity: Kirsch et al. (1985).  Under the conditions of this study the no-adverse-effect-level (NOAEL) is between 50 ppm and 150 ppm from the pathological point of view.   Sub-Chronic Repeated Dose Toxicity: Reinart (1977). Under the conditions of the study the no-effect level was 200 ppm.   Sub-Chronic Repeated Dose Toxicity: Rondot et al. (1978). As in the preceding study, no behavioural change which could be attributed to the ingestion of the test materials was observed. A dose-related reduction of the growth rate was however noted. No ocular lesion was observed. The histological examination of the eyes of all animals at the end of the study revealed no treatment-related lesion.   Chronic Repeated Dose Toxicity: Kuehborth (1988). Under the conditions of the study a dose-dependent increase in the kidney weights of the male rats of the 100 and 400 ppm groups was observed, while the kidney weights of the female animals remained uninfluenced. Therefore the NOAEL for male rats was 20 ppm (equivalent to 1.1 mg/kg bodyweight/ day) and for female rats was 400 ppm (equivalent to 27.9 mg/kg bodyweight/ day).   Repeated Dose Toxicity: Oral 13 week. Reuzel (1979) Under the conditions of this study, the NOAEL was 4 mg/kg bw/day. Range-Finding Study: Reuzel et al. (1977) Under the conditions of this study, no noticeable differences in the effects observed by oral administration of the test material either in the diet or by capsule were seen. Short-Term Repeated Dose Toxicity Via the Dermal Route: Allan et al. (1993) Under the conditions of the study it was considered that 1 000 mg/kg/day represents a NOAEL in the rabbit in terms of systemic toxicity while a no effect level for dermal irritation was not established. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78704aa3-5862-4fc4-8bb3-3f9d18768077/documents/e0d90b53-92e5-48cb-bc2d-3ccf90c9f318_5095129c-3c9b-4501-b7f6-9e80b3c9333f.html,,,,,, Mecoprop,7085-19-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78704aa3-5862-4fc4-8bb3-3f9d18768077/documents/e0d90b53-92e5-48cb-bc2d-3ccf90c9f318_5095129c-3c9b-4501-b7f6-9e80b3c9333f.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rabbit Mecoprop,7085-19-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78704aa3-5862-4fc4-8bb3-3f9d18768077/documents/e0d90b53-92e5-48cb-bc2d-3ccf90c9f318_5095129c-3c9b-4501-b7f6-9e80b3c9333f.html,Chronic toxicity – systemic effects,oral,NOAEL,1.1 mg/kg bw/day,,rat Mecoprop,7085-19-0," Acute Oral Toxicity Key Study: Kirsch (1983) Under the conditions of this study, the acute oral LD50 of the test material was 1 166 mg/kg.   Acute Inhalation Toxicity Key Study: Klimisch (1986) Under the conditions of this study, the acute inhalation LC50 (4 h) of the test material was found to be >12.5 mg/L. Acute Inhalation Toxicity Supporting Study: Coombs (1977) Under the conditions of this study it was not possible to generate the dust of the test material above a mean level of 0.02 g/m^3. It was found to be difficult to generate a significant level of dust of the test material due to the cohesive nature of the material. It is expected that the test material is unlikely to produce any appreciable level of respirable dust under normal handling conditions. Acute Dermal Toxicity Key Study: Kirsch (1983) Under the conditions of this study, the acute dermal LD50 of the test material to rats was > 4 000 mg/kg.   Acute Intraperitoneal Toxicity Supporting Study: Kirsch (1988) Under the conditions of this study, the acute LD50 after a single intraperitoneal administration of test material in male and female rats was found to be > 200 < 700 mg/kg.   Acute Intraperitoneal Toxicity Supporting Study: Kirsch (1983) Under the conditions of this study, the acute LD50 after a single intraperitoneal administration of test material in male and female rats was approximately 464 mg/kg bw.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78704aa3-5862-4fc4-8bb3-3f9d18768077/documents/9277a969-47c5-4490-8131-82303a74c52c_5095129c-3c9b-4501-b7f6-9e80b3c9333f.html,,,,,, Mecoprop,7085-19-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78704aa3-5862-4fc4-8bb3-3f9d18768077/documents/9277a969-47c5-4490-8131-82303a74c52c_5095129c-3c9b-4501-b7f6-9e80b3c9333f.html,,oral,LD50,"1,166 mg/kg bw",adverse effect observed, Mecoprop,7085-19-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78704aa3-5862-4fc4-8bb3-3f9d18768077/documents/9277a969-47c5-4490-8131-82303a74c52c_5095129c-3c9b-4501-b7f6-9e80b3c9333f.html,,dermal,LD50,"> 4,000 mg/kg bw",no adverse effect observed, Mecoprop,7085-19-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78704aa3-5862-4fc4-8bb3-3f9d18768077/documents/9277a969-47c5-4490-8131-82303a74c52c_5095129c-3c9b-4501-b7f6-9e80b3c9333f.html,,inhalation,LC50,> 12.5 mg/L,adverse effect observed, mecoprop-P (ISO); (R)-2-(4-chloro-2-methylphenoxy)propionic acid,16484-77-8," Short-Term Repeated Dose Toxicity, Oral: Mellert (2003a) Under the conditions of the study there are clear indications of peroxisome proliferation in both liver and kidney at the 400 and 800 ppm inclusion rates. At 100 ppm there was a clear effect in the kidney, but not the liver, for both sexes, this is important as it reinforces the kidney as the primary organ affected, and shows that there was already significant proliferation at the high dose in the 2 year study. Short-Term Repeated Dose Toxicity, Oral: Beimborn & Leibold (2003) Under the conditions of the study the body weight changes were slightly decreased in groups dosed with 500 and 1 000 ppm and markedly in groups fed with 1 500 and 2 200 ppm. No test-material related clinical findings were observed. Short-Term Repeated Dose Toxicity, Oral: Beimborn & Leibold (2004) Under the conditions of the study the body weight changes were slightly decreased in groups dosed with 570, 760 and 950 ppm. No test-material related clinical findings were observed. Short-Term Repeated Dose Toxicity, Oral: Mellert (2003b) Under the conditions of the study the results are clearly indicative of peroxisome proliferation in both liver and kidney. Short-Term Repeated Dose Toxicity, Oral: Kirsch (1986) Under the conditions of the study, the no effect level is between 50 and 400 ppm for both the racemate and the isomer. Sub-Chronic Repeated Dose Toxicity, Oral: Mellert et al. (1995) Under the conditions of this study the no effect level for neurotoxicity was therefore above 3 000 ppm in females and above 2 500 ppm in males. The NOAEL for systemic toxicity was 75 ppm (about 6 mg/kg bw/day). Sub-Chronic Repeated Dose Toxicity, Oral: Rondot (1998) Under the conditions of the study no behavioural change which could be attributed to the ingestion of the test materials was observed. A dose-related reduction of the growth rate was however noted. No ocular lesion was observed. The histological examination of the eyes of all animals at the end of the study revealed no treatment-related lesion. Sub-Chronic Repeated Dose Toxicity, Oral: Reinert (1998) Under the conditions of the study the no-effect level was 200 ppm for both the racemate and the isomer. Sub-Chronic Repeated Dose Toxicity, Oral: Mellert (1993) Under the conditions of thestudy, the no observed adverse effect level in this study is for male animals 100 ppm and for female animals slightly below 100 ppm Chronic Repeated Dose Toxicity, Oral: Bachmann et al. (1997) Under the conditions of the study it can be stated that the test material administered with the diet to Beagle dogs in a dose of 600 ppm led to retarded body weight change and to slight decreases in haemoglobin concentrations and haematocrit values in the peripheral blood in the males and to slight decreases in inorganic phosphate and calcium in the females. No toxicologically relevant findings occurred in the male and female dogs receiving 180 ppm and 60 ppm of the test material. The no observed adverse affect level (NOAEL) for male and female Beagle dogsunder the chosen test conditions is 180 ppm (approx. 5 mg/kg bw/day). Chronic Repeated Dose Toxicity, Oral: Kuehborth et al. (1988) Under the conditions of the study a dose-dependent increase in the kidney weights of the male rats of the 100 and 400 ppm groups was observed, while the kidney weights of the female animals remained uninfluenced. Thereore the NOAEL for male rats was 20 ppm (equivalent to 1.1 mg/kg bodyweight/ day) and for female rats was 400 ppm (equivalent to 27.9 mg/kg bodyweight/ day). Short-Term Repeated Dose Toxicity, Dermal: Allan et al. (1993) Under the conditions of the study it was considered that 1 000 mg/kg bw/day represents a NOAEL in the rabbit in terms of systemic toxicity while a no effect level for dermal irritation was not established. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/52a40759-f8ae-4b18-8546-66d1a8e3c658/documents/c4ba16f2-63b4-4f11-a7dc-d3443e002125_69b7a76a-f161-4e12-8485-c223f5838348.html,,,,,, mecoprop-P (ISO); (R)-2-(4-chloro-2-methylphenoxy)propionic acid,16484-77-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/52a40759-f8ae-4b18-8546-66d1a8e3c658/documents/c4ba16f2-63b4-4f11-a7dc-d3443e002125_69b7a76a-f161-4e12-8485-c223f5838348.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rabbit mecoprop-P (ISO); (R)-2-(4-chloro-2-methylphenoxy)propionic acid,16484-77-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/52a40759-f8ae-4b18-8546-66d1a8e3c658/documents/c4ba16f2-63b4-4f11-a7dc-d3443e002125_69b7a76a-f161-4e12-8485-c223f5838348.html,Chronic toxicity – systemic effects,oral,NOAEL,5.4 mg/kg bw/day,,dog mecoprop-P (ISO); (R)-2-(4-chloro-2-methylphenoxy)propionic acid,16484-77-8," Acute Toxicity: Oral Route: Cummins (1990) Under the conditions of the study, the combined acute oral LD50 for male and female CD rats was 775 mg/kg (95 % confidence limits of 666 – 885).  The test material was considered acutely toxic via the oral route (Category 4). Acute Toxicity: Oral Route, Supporting Study: Dange (1994) Under the conditions of this study, the acute oral LD50 of the test material was determined to be 431 mg/kg bw in male and female Sprague-Dawley rats. Acute Toxicity: Inhalation Route: Cracknell (1990) Under the conditions of this study, there were no deaths following the exposure for four hours of five male and five female rats to the maximum chamber concentration that could be generated using the methods described in this report. The median lethal chamber concentration for four hours' exposure (LC50 4-hour) is therefore greater than 0.87 mg per litre of air. Acute Toxicity: Inhalation Route: Coombs (1977) Under the conditions of this study, the acute inhalation LC50 was > 2.21 g/m^3. Acute Toxicity: Dermal Route: Cummins (1990) Under the conditions of this study, the acute percutaneous median lethal dosage (LD50) of the test material was greater than 2 000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52a40759-f8ae-4b18-8546-66d1a8e3c658/documents/77e7b482-daf7-43a5-b217-ac39ecb352df_69b7a76a-f161-4e12-8485-c223f5838348.html,,,,,, mecoprop-P (ISO); (R)-2-(4-chloro-2-methylphenoxy)propionic acid,16484-77-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52a40759-f8ae-4b18-8546-66d1a8e3c658/documents/77e7b482-daf7-43a5-b217-ac39ecb352df_69b7a76a-f161-4e12-8485-c223f5838348.html,,oral,LD50,431 mg/kg bw,adverse effect observed, Mecrilate,137-05-3,All available data on methyl 2-cyanoacrylate (MCA) and the structural homologue ethyl 2-cyanoacrylate (ECA) indicate an absence of lethal effects after application of doses >2000 mg/kg body weight via the oral or dermal route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8784fa16-4141-4788-8d01-ab920660e329/documents/IUC5-2fda4a7e-3dde-4148-a776-ed0fa7aa4628_30ded615-36a9-44ea-864e-904a4a972656.html,,,,,, "Menthane, monohydroperoxy derivative",26762-92-5,"No sub-chronic toxicity studies are yet available on the test substance, while one repeated dose toxicity study by oral route is currently performed following ECHA decision CCH-D-2114589073-44-01/F. On the structural analogue cumenehydroperoxide a 90-day inhalation study in rats was performed with test concentrations of 1, 6, 31 and 124 mg/m³. All rats died or were killed in extremis at 124 mg/m³ before day 12 of the study showing tissue irritation at the site of contact and included ulceration and inflammation of the cornea and eyes, nasal turbinates and lining of the stomach. Secondary effects included thymic atrophy, depletion of lymphoid tissue in the germinal centers of some lymph nodes and the spleen, decreased lipid content of the liver and decreased number of circulating white blood cells. The exposure of 1, 6 or 31 mg/m³ cumene hydroperoxide induced no substance related statistically significant effects on haematology, urinalysis, clinical chemistry, body weights, organ weights and pathology. NTP has performed repeated dose studies with cumene hydroperoxide in mice and rats with topical application of the test substance. In the 13-week studies at 6 mg/kg bw and above treatment related effects were found at the application site which included, hyperplasia of the sebaceous glands inflammation of the dermis and degeneration, exudate, ulcer, necrosis, hyperkeratosis and squamous hyperplasia of the epidermis. The effects increased in severity with increasing dose. No treatment related systemic effects were found. The NOAEL is 3 mg/kg bw (equivalent to 0.6%/0.018mg/cm² in rats and 0.15%/0.009 mg/cm² in mice). In addition data on dermal irritation at different dose levels are available from 2 sensitisation studies with the test substance. The NOAEL for dermal irritation of 1% is based on the lowest non-irritant concentration as assessed in the CIT maximisation study (1994). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e048966-f549-4086-b7ef-866b232d1cb0/documents/IUC5-612dceb8-4d24-40c7-bc74-bccf01ba2851_dba03f2b-942e-4129-879b-e55908c9fb22.html,,,,,, "Menthane, monohydroperoxy derivative",26762-92-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e048966-f549-4086-b7ef-866b232d1cb0/documents/IUC5-612dceb8-4d24-40c7-bc74-bccf01ba2851_dba03f2b-942e-4129-879b-e55908c9fb22.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,> 3 mg/kg bw/day,,rat "Menthane, monohydroperoxy derivative",26762-92-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e048966-f549-4086-b7ef-866b232d1cb0/documents/IUC5-612dceb8-4d24-40c7-bc74-bccf01ba2851_dba03f2b-942e-4129-879b-e55908c9fb22.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,> 31 mg/m3,,rat "Menthane, monohydroperoxy derivative",26762-92-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e048966-f549-4086-b7ef-866b232d1cb0/documents/IUC5-612dceb8-4d24-40c7-bc74-bccf01ba2851_dba03f2b-942e-4129-879b-e55908c9fb22.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.009 mg/cm2,adverse effect observed,rat "Menthane, monohydroperoxy derivative",26762-92-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e048966-f549-4086-b7ef-866b232d1cb0/documents/IUC5-612dceb8-4d24-40c7-bc74-bccf01ba2851_dba03f2b-942e-4129-879b-e55908c9fb22.html,Repeated dose toxicity – local effects,inhalation,NOAEC,31 mg/m3,adverse effect observed,rat "Menthane, monohydroperoxy derivative",26762-92-5,"The oral LD50 value of the test substance tested in rats is > 2000 mg/kg bw. This is supported by tests with the structural analogues such as cumene hydroperoxide (Dow 1975) and diisopropyl benzene hydroperoxide (Hüls 1984), showing similar acute oral toxicity data. No additional acute toxicity studies investigating the dermal or inhalation route were performed with the test substance due to its corrosive properties. A dermal toxicity study in rabbits with the structural analogue cumene hydroperoxide is available but is considered unsuitable for evaluation in view of the low quality. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e048966-f549-4086-b7ef-866b232d1cb0/documents/IUC5-364147eb-843c-4f0e-b46a-918750ba5aaf_dba03f2b-942e-4129-879b-e55908c9fb22.html,,,,,, "Menthane, monohydroperoxy derivative",26762-92-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e048966-f549-4086-b7ef-866b232d1cb0/documents/IUC5-364147eb-843c-4f0e-b46a-918750ba5aaf_dba03f2b-942e-4129-879b-e55908c9fb22.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Merbromin,129-16-8," Acute oral toxicity: LD50 was estimated to be 360 mg/kg bw when mice were orally exposed with disodium [2,7-dibromo-9-(2-carboxylatophenyl)-6-oxido-3-oxo-3H-xanthen-5-yl]mercurol. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e82e3a50-e9c5-43e4-bfc6-251901dc5831/documents/a42704c2-b692-46cf-a1bb-d0dc5c18252c_3ebd37e7-c074-446e-9631-91eb50daea9a.html,,,,,, Merbromin,129-16-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e82e3a50-e9c5-43e4-bfc6-251901dc5831/documents/a42704c2-b692-46cf-a1bb-d0dc5c18252c_3ebd37e7-c074-446e-9631-91eb50daea9a.html,,oral,LD50,360 mg/kg bw,adverse effect observed, Mercury sulphate,7783-35-9,"Repeated oral Toxicity: The lethal dose value was found to be 3.75mg/kgbw when administered in rats for sub chronic toxicity. Repeated Inhalation Toxicity: The repeated inhalation toxicity study need not be conducted because, the given test chemical is very toxic by inhalation exposure and there is no data are available to support or revise this classification. Also the exposure to humans via inhalation route is not likely taking into account due to the very low vapor pressure of the test chemical. Thus, exposure to inhalable dust, mist and vapor of the chemical is highly unlikely. Therefore this study is considered for waiver. Repeated dermal Toxicity: The repeated dermal study can be waived as the pH of the substance is 1.72 which states the substance is highly acidic The substance belongs to category 1 of skin corrosion.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0970889-f152-48c9-8388-5816af82d796/documents/1c8a2df1-4eb0-4f5d-b10e-1abbd9518d39_edba2e51-5e2d-4c1e-bf71-5574459c3ee9.html,,,,,, Mercury sulphate,7783-35-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0970889-f152-48c9-8388-5816af82d796/documents/1c8a2df1-4eb0-4f5d-b10e-1abbd9518d39_edba2e51-5e2d-4c1e-bf71-5574459c3ee9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,3.75 mg/kg bw/day,,rat Mercury sulphate,7783-35-9,"Acute oral toxicity:  The acute oral LD50 value was considered to be 25 mg/kg bw, when mice were treated with the given test chemical via oral route.   Acute Inhalation toxicity:  The acute inhalation toxicity study need not be conducted because, the given test chemical is very toxic by inhalation exposure and there is no data are available to support or revise this classification.   Acute Dermal toxicity:  the study does not need to be conducted because the substance is classified as corrosive to the skin ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0970889-f152-48c9-8388-5816af82d796/documents/0722b77a-3d5b-437b-9844-4a0be8632f5b_edba2e51-5e2d-4c1e-bf71-5574459c3ee9.html,,,,,, Mercury sulphate,7783-35-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0970889-f152-48c9-8388-5816af82d796/documents/0722b77a-3d5b-437b-9844-4a0be8632f5b_edba2e51-5e2d-4c1e-bf71-5574459c3ee9.html,,oral,LD50,25 mg/kg bw,adverse effect observed, Metam-sodium,137-42-8, Repeated dose oral toxicity: NOEL was considered to be 0.3 mg/kg bw /day for Metam Sodium in male and female rats for sub chronic study by oral gavage. Repeated inhalation study: NOAEL was considered to be 0.51 mg/l for Metam Sodium in Sprague–Dawley male and female rats for subacute study by inhalation route. Repeated dermal study; NOAEL was considered to be 31.25 mg/kg bw/day for Metam Sodium in White Russians male and female rabbits for 21 days by dermal application. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0368427-4d0e-4db0-94cc-8981663025ce/documents/84a6a59e-4ede-411b-a6b8-a7a7e9c387c6_1ab84c44-33e9-4999-9867-5e42e4fc5905.html,,,,,, Metam-sodium,137-42-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0368427-4d0e-4db0-94cc-8981663025ce/documents/84a6a59e-4ede-411b-a6b8-a7a7e9c387c6_1ab84c44-33e9-4999-9867-5e42e4fc5905.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,31.25 mg/kg bw/day,,rabbit Metam-sodium,137-42-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0368427-4d0e-4db0-94cc-8981663025ce/documents/84a6a59e-4ede-411b-a6b8-a7a7e9c387c6_1ab84c44-33e9-4999-9867-5e42e4fc5905.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,0.51 mg/m3,,rat Metam-sodium,137-42-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0368427-4d0e-4db0-94cc-8981663025ce/documents/84a6a59e-4ede-411b-a6b8-a7a7e9c387c6_1ab84c44-33e9-4999-9867-5e42e4fc5905.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.3 mg/kg bw/day,,rat Metam-sodium,137-42-8," Acute oral toxicity:  Acute oral toxicity dose (LD50) of Metam-sodium (CAS no: 137-42-8) was considered based on different experimental studies conducted on rats, rabbits, mice and guinea pigs. The LD50 value was considered to be 896 mg/kg bw in Male and female rats; 870 mg/kg bw in Male rats and 924 mg/kg bw in Female rats. The study concluded that the LD50 value is between 300-2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Metam-sodium (CAS no: 137-42-8) can be classified as “Category 4” for acute oral toxicity. Acute Inhalation toxicity:  Acute Inhalation toxicity dose (LC50) for Metam-sodium (CAS no: 137-42-8) was considered based on different experimental studies conducted on rats. The LC50 value was considered to be > 6.8 mg/L (>6800 mg/m3). The study concluded that the LC50 value is >5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, Metam-sodium cannot be classified for acute Inhalation toxicity. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for Metam-sodium (CAS no: 137-42-8) was considered based on different experimental studies on rats and rabbits for acute dermal toxicity. The LD50 value was considered to be 3074 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Metam-sodium cannot be classified for acute dermal toxicity ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0368427-4d0e-4db0-94cc-8981663025ce/documents/82653f35-f8fa-4632-9bf3-8e297099e3c9_1ab84c44-33e9-4999-9867-5e42e4fc5905.html,,,,,, Metam-sodium,137-42-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0368427-4d0e-4db0-94cc-8981663025ce/documents/82653f35-f8fa-4632-9bf3-8e297099e3c9_1ab84c44-33e9-4999-9867-5e42e4fc5905.html,,oral,LD50,896 mg/kg bw,adverse effect observed, Metam-sodium,137-42-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0368427-4d0e-4db0-94cc-8981663025ce/documents/82653f35-f8fa-4632-9bf3-8e297099e3c9_1ab84c44-33e9-4999-9867-5e42e4fc5905.html,,dermal,LD50,"3,074 mg/kg bw",no adverse effect observed, Metam-sodium,137-42-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0368427-4d0e-4db0-94cc-8981663025ce/documents/82653f35-f8fa-4632-9bf3-8e297099e3c9_1ab84c44-33e9-4999-9867-5e42e4fc5905.html,,inhalation,LC50,"6,800 mg/m3",no adverse effect observed, Metenolone,153-00-4,"There are no repeat-dose studies with ZK 5466. Read-across to results of studies with metenolone acetate (ZK 5469):Subcutaneous, 2 weeks (Rat, non-GLP, dose: 0/ 4 mg, once daily): no effect[Schering AG, 1960-11-29]Subcutaneous, 26 weeks (Rat, non-GLP, doses: 0/ 0.33/ 3/ 10 mg/kg, every second day): NOEL < 0.33 mg/kg[Schering AG, 1967-06-15]Subcutaneous, 26 weeks (Dog-Beagle, non-GLP, doses: 0/ 6/ 20/ 40 mg/kg, every second day): NOEL: 6 mg/kg[Schering AG, 1967-06-15]Read-across to results of studies with ZK 5782 (metenolone enanthate):Subcutaneous, 26 weeks (Rat, non-GLP, Doses: 0/ 1.5/ 15/ 50 mg/kg, once every second week; twice/week at high dose over last month): NOEL < 1.5 mg/kg[Schering AG, 1962-02-07]Subcutaneous, 26 weeks (Dog, non-GLP, Doses: 0/ 3/ 10 / 20 mg/kg, once every second week; twice/week at high dose over last month): NOEL = 20 mg/kg[Schering AG, 1962-02-07] ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/afef3523-1606-4c34-95bf-8b1c1f26e33c/documents/IUC5-5044bd5b-2d12-49d5-b619-e0a5e67066ca_26b2af92-7cff-4569-94cb-6781effe020a.html,,,,,, Metenolone,153-00-4,"Oral (Mouse, non-GLP): LD50 = 1700 mg/kg[Schering AG, 1961-11-24]Oral (Rat, non-GLP): LD50 > 2000 mg/kg[Schering AG, 1961-11-24]Intraperitoneal (Mouse, non-GLP): LD50 = 490 mg/kg[Schering AG, 1961-11-24]Intraperitoneal (Rat, non-GLP): LD50 = 560 mg/kg[Schering AG, 1961-12-07] ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/afef3523-1606-4c34-95bf-8b1c1f26e33c/documents/IUC5-dcce5508-5a56-4415-acf7-8d834c539e8d_26b2af92-7cff-4569-94cb-6781effe020a.html,,,,,, Metformin hydrochloride,1115-70-4," Metformin hydrochloride was tested in a chronic oral toxicity study in mice, which was performed according to OECD 452 and under GLP regulation. From this study, a NOAEL of 450 mg/kg bw/day was established based on effects on body weight and cystic tubular dilatation in the kidney. In another non-GLP repeat study, rats were daily treated with metformine over a period of 26 weeks Based on the effects observed in this study (clinical signs, body weight reduction, kidneys), a NOAEL value of 300 mg/kg bw/day could be established. Despite not performed under GLP, this study is acceptable to support the assessment of the toxicity of Metformin hydrochloride. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/655efa36-ae8c-4da6-ba59-7387e637a6d0/documents/IUC5-8e55c161-bc1a-4a4c-8793-1384e27753ac_9e4beb41-adcf-4dfe-b903-75dff03b9ccc.html,,,,,, Metformin hydrochloride,1115-70-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/655efa36-ae8c-4da6-ba59-7387e637a6d0/documents/IUC5-8e55c161-bc1a-4a4c-8793-1384e27753ac_9e4beb41-adcf-4dfe-b903-75dff03b9ccc.html,Chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Metformin hydrochloride,1115-70-4, The acute toxicity of Metformin hydrochlorid was studied in various species via the oral route of administration. The LD50 values varied between 375 mg/kg bw in dogs and 2400 mg/kg bw in mice. For rats an LD50 (m/f) of 1770 mg/kg bw is reported. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/655efa36-ae8c-4da6-ba59-7387e637a6d0/documents/IUC5-a91de4a5-62af-414c-bc68-6284edf8fcf0_9e4beb41-adcf-4dfe-b903-75dff03b9ccc.html,,,,,, Metformin hydrochloride,1115-70-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/655efa36-ae8c-4da6-ba59-7387e637a6d0/documents/IUC5-a91de4a5-62af-414c-bc68-6284edf8fcf0_9e4beb41-adcf-4dfe-b903-75dff03b9ccc.html,,oral,LD50,"1,770 mg/kg bw",adverse effect observed, Methacrylaldehyde,78-85-3," Subchronic inhalation study: Histopathological changes were confined to the nasal passages and larynges of rats exposed to 15 ppm. The changes comprised epithelial inflammatory, atrophic and metaplastic changes seen in the dorsal meatus and dorsal central septum of the nasal passages and, to a lesser degree, in the larynges. These changes are consistent with the inhalation of an irritant substance. Clear signs of repair and recovery of the above changes were seen in rats killed following the 4-week recovery period. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/68d188e2-de9c-407f-9ea8-7fd4f477e278/documents/d6d48d45-5abb-4cf9-bd39-7c33a8df266c_da976d11-2a34-4ab3-b31b-7892e73ba4b4.html,,,,,, Methacrylaldehyde,78-85-3, LD50 rat oral: 140 mg/kg bw LC50 rat inhalation: 0.56 mg/l/ 4h LD50 rabbit dermal: ca. 364 mg/kg bw H301: Toxic if swallowed. H311: Toxic in contact with skin. H330: Fatal if inhaled. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68d188e2-de9c-407f-9ea8-7fd4f477e278/documents/7aea5d18-55f2-4774-90f6-0224305155f4_da976d11-2a34-4ab3-b31b-7892e73ba4b4.html,,,,,, Methacrylic anhydride,760-93-0," No data available for MAAH. Read across data from methacrylic acid, MAA (hydrolysis product and primary metabolite) and methyl methacrylate, MMA (metabolite donor substance; read across justification see attached document): oral 2 yr drinking water, rats, MMA: NOAEL 2000 ppm = 124/ 164 mg/kg bw/d in males and females inhalation 90 d/ OECD 413, rats, MAA: NOAEC 100 ppm (male/female) (= 352 mg/m³ for local effects and unspecific systemic effects to body weight) 2 yr, NTP protocol, rats, MMA: NOAEC 350 ppm (male/female) (= 1232 mg/m³ for systemic effects in target organs other than body weight effects due to reduced food consumption) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/28df1a88-a4d5-47d2-a70f-678cd88b023b/documents/0383c808-4053-4ae1-9df5-e12fa73f66fd_c5165e05-e2c5-4db7-96ae-0982a3fd49cc.html,,,,,, Methacrylic anhydride,760-93-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/28df1a88-a4d5-47d2-a70f-678cd88b023b/documents/0383c808-4053-4ae1-9df5-e12fa73f66fd_c5165e05-e2c5-4db7-96ae-0982a3fd49cc.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,232 mg/m3",,rat Methacrylic anhydride,760-93-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/28df1a88-a4d5-47d2-a70f-678cd88b023b/documents/0383c808-4053-4ae1-9df5-e12fa73f66fd_c5165e05-e2c5-4db7-96ae-0982a3fd49cc.html,Repeated dose toxicity – local effects,inhalation,NOAEC,352 mg/m3,adverse effect observed,rat Methacrylic anhydride,760-93-0," LD50 rat, oral: 1550 mg/kg LC50 rat, inhal.: 2.081 to 5 mg/l (aerosol). No study was available for dermal exposure. For the metabolite donor substance MMA, a dermal study in rabbits is available with an LD50 of > 5000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28df1a88-a4d5-47d2-a70f-678cd88b023b/documents/b80ffc47-a205-44d4-b980-2e86f5ebecbb_c5165e05-e2c5-4db7-96ae-0982a3fd49cc.html,,,,,, Methacrylic anhydride,760-93-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28df1a88-a4d5-47d2-a70f-678cd88b023b/documents/b80ffc47-a205-44d4-b980-2e86f5ebecbb_c5165e05-e2c5-4db7-96ae-0982a3fd49cc.html,,oral,LD50,"1,550 mg/kg bw",adverse effect observed, Methacrylic anhydride,760-93-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28df1a88-a4d5-47d2-a70f-678cd88b023b/documents/b80ffc47-a205-44d4-b980-2e86f5ebecbb_c5165e05-e2c5-4db7-96ae-0982a3fd49cc.html,,inhalation,LC50,"2,100 mg/m3",adverse effect observed, Methacrylonitrile,126-98-7,Oral NOAEL of 7.5 mg/kg bw/day with gender specific differences in the rat (OECD 422 and 408)Oral NOAEL of 6 mg/kg bw/day in male and female mice (OECD 422)Inhalation NOAEL of 19.3-52.6 ppm in male and female rats (published data)Inhalation NOAEL of 3.2-8.8 ppm in male dogs (published data) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce352988-7dd8-4a65-85a7-ba29d04710d8/documents/IUC5-6da02b7c-3f0c-45be-963a-ad8fb1db23bd_6edd18f8-c0a0-4211-bd86-d77e379cd59d.html,,,,,, Methacrylonitrile,126-98-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce352988-7dd8-4a65-85a7-ba29d04710d8/documents/IUC5-6da02b7c-3f0c-45be-963a-ad8fb1db23bd_6edd18f8-c0a0-4211-bd86-d77e379cd59d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,7.5 mg/kg bw/day,,rat Methacrylonitrile,126-98-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce352988-7dd8-4a65-85a7-ba29d04710d8/documents/IUC5-6da02b7c-3f0c-45be-963a-ad8fb1db23bd_6edd18f8-c0a0-4211-bd86-d77e379cd59d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,53.8 mg/m3,,rat Methacrylonitrile,126-98-7,Oral LD50 64 mg/kg bw in male rats and 73 mg/kg bw in female rats (OECD 401)Dermal LD50 256 mg/kg bw in male rabbits (weight of evidence from published data)Inhalation LD50 496 ppm in female rats and 398 ppm in male rats (published data) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce352988-7dd8-4a65-85a7-ba29d04710d8/documents/IUC5-d3d44bd7-7f21-42f2-a463-37beb7d346f8_6edd18f8-c0a0-4211-bd86-d77e379cd59d.html,,,,,, Methacrylonitrile,126-98-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce352988-7dd8-4a65-85a7-ba29d04710d8/documents/IUC5-d3d44bd7-7f21-42f2-a463-37beb7d346f8_6edd18f8-c0a0-4211-bd86-d77e379cd59d.html,,oral,LD50,64 mg/kg bw,adverse effect observed, Methacrylonitrile,126-98-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce352988-7dd8-4a65-85a7-ba29d04710d8/documents/IUC5-d3d44bd7-7f21-42f2-a463-37beb7d346f8_6edd18f8-c0a0-4211-bd86-d77e379cd59d.html,,dermal,LD50,256 mg/kg bw,adverse effect observed, Methacrylonitrile,126-98-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce352988-7dd8-4a65-85a7-ba29d04710d8/documents/IUC5-d3d44bd7-7f21-42f2-a463-37beb7d346f8_6edd18f8-c0a0-4211-bd86-d77e379cd59d.html,,inhalation,LC50,"1,092 mg/m3",adverse effect observed, "Methanal, reaction products with 1,3-bis(aminomethyl)benzene and hydroxybenzene",1950616-36-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The acute rat oral LD50 was determined to be > 2000 mg/kg of body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0913cb7-815f-402f-9877-8b4e9beda66b/documents/IUC5-e4de8517-a178-4c19-9aa3-83d428879465_0993ba47-ae5a-45c2-af2e-934f43f2b8f8.html,,,,,, "Methanal, reaction products with 1,3-bis(aminomethyl)benzene and hydroxybenzene",1950616-36-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0913cb7-815f-402f-9877-8b4e9beda66b/documents/IUC5-e4de8517-a178-4c19-9aa3-83d428879465_0993ba47-ae5a-45c2-af2e-934f43f2b8f8.html,,dermal,,"2,000 mg/kg bw",adverse effect observed, "Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate",18015-76-4,MGC rat LOEL (28d): 40 mg/kg bw/day (males and females)MGC mouse LOEL (28d): 50 mg/kg bw/day (males)MGC mouse LOEL (28d): 20 mg/kg bw/day (females) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04cb0570-d767-4b72-ae88-e60c1ac4672e/documents/307cd629-7255-4a4e-8dcf-62ccbc2d11d8_9ce79ad2-559b-47f0-bcb5-d19c00b07f69.html,,,,,, "Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate",18015-76-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/04cb0570-d767-4b72-ae88-e60c1ac4672e/documents/307cd629-7255-4a4e-8dcf-62ccbc2d11d8_9ce79ad2-559b-47f0-bcb5-d19c00b07f69.html,Short-term repeated dose toxicity – systemic effects,oral,,20 mg/kg bw/day,,mouse "Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate",18015-76-4,Oral toxicity: LD50 < 2000 mg/kg bwDermal toxicity: LD50 > 2000 mg/kg bwInhalatory exposure is unlikely. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04cb0570-d767-4b72-ae88-e60c1ac4672e/documents/IUC5-7ed440a5-d425-4dd1-9d22-cb79ddb2fc11_9ce79ad2-559b-47f0-bcb5-d19c00b07f69.html,,,,,, "Methanaminium, N-[4-[[4-(dimethylamino)phenyl]phenylmethylene]-2,5-cyclohexadien-1-ylidene]-N-methyl-, ethanedioate",18015-76-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/04cb0570-d767-4b72-ae88-e60c1ac4672e/documents/IUC5-7ed440a5-d425-4dd1-9d22-cb79ddb2fc11_9ce79ad2-559b-47f0-bcb5-d19c00b07f69.html,,dermal,,"2,000 mg/kg bw",no adverse effect observed, Methane,74-82-8,"Members of the Petroleum Gases category show low sub-chronic toxicity by the inhalation route of exposure, the most relevant route. No significant exposure-related toxicological effects or target organ toxicity have been observed in inhalation studies up to 90 days duration for the C2-C4 alkanes, as well as Liquefied Petroleum Gas, the composition of which is mainly propane and propene. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9043aaa0-7fef-46df-b73d-3eef36fa5007/documents/ba77d676-dd2c-4fee-b20d-dca5d14ae9e3_478d528b-daf8-42b8-8b5b-e799f35b0644.html,,,,,, Methane,74-82-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9043aaa0-7fef-46df-b73d-3eef36fa5007/documents/ba77d676-dd2c-4fee-b20d-dca5d14ae9e3_478d528b-daf8-42b8-8b5b-e799f35b0644.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"4,437 mg/m3",,rat Methane,74-82-8,"Members of the Petroleum Gases category are flammable gases at room temperature and therefore the requirement for data on acute oral and dermal toxicity is waived in accordance with REACH Annex XI. Across species, the gases in this category show low acute inhalation toxicity. Indeed they are practically nontoxic for single exposures below their lower flammability limit, most of which range between 1.8-3.2%, circa 39,000 – 43,000 mg/m3. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9043aaa0-7fef-46df-b73d-3eef36fa5007/documents/9b3b5f27-cc4b-4cde-af95-a518af935467_478d528b-daf8-42b8-8b5b-e799f35b0644.html,,,,,, "N-{2-[(4,6-dimethoxy-1,3,5-triazin-2-yl)carbonyl]-6-fluorophenyl}-1,1-difluoro-N-methylmethanesulfonamide",874195-61-6,"NOAEL (oral, dog, 1 year): 2.8 and 3.0 mg/kg bw/day for males and females, respectively NOAEL (oral, rat, 90 days): 16.4 and 20 mg/kg bw/day for males and females, respectivelyNOAEL (oral, mouse, 90 days): 1001 and 1170 mg/kg bw/day for males and females, respectivelyLOAEL (oral, dog, 90 days): 27.2 and 30.3 mg/kg bw/day for males and females, respectively NOAEL (dermal, rat, 28 days): 500 mg/kg bw/day for males and females ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/42a33770-acf5-4c71-86a4-d4f6f18cddf8/documents/c3ed0a92-c415-4ee4-9e7f-f6231828537e_3f6c7eb6-3148-406f-bec0-7236e064a6a9.html,,,,,, "N-{2-[(4,6-dimethoxy-1,3,5-triazin-2-yl)carbonyl]-6-fluorophenyl}-1,1-difluoro-N-methylmethanesulfonamide",874195-61-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/42a33770-acf5-4c71-86a4-d4f6f18cddf8/documents/c3ed0a92-c415-4ee4-9e7f-f6231828537e_3f6c7eb6-3148-406f-bec0-7236e064a6a9.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rat "N-{2-[(4,6-dimethoxy-1,3,5-triazin-2-yl)carbonyl]-6-fluorophenyl}-1,1-difluoro-N-methylmethanesulfonamide",874195-61-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/42a33770-acf5-4c71-86a4-d4f6f18cddf8/documents/c3ed0a92-c415-4ee4-9e7f-f6231828537e_3f6c7eb6-3148-406f-bec0-7236e064a6a9.html,Chronic toxicity – systemic effects,oral,NOAEL,2.8 mg/kg bw/day,,dog "N-{2-[(4,6-dimethoxy-1,3,5-triazin-2-yl)carbonyl]-6-fluorophenyl}-1,1-difluoro-N-methylmethanesulfonamide",874195-61-6,"Oral (OECD 423), rat and mouse: LD50 > 2000 mg/kg bw (limit test)Inhalation (OECD 403), rat: LCD50 > 5297.5 mg/m³ (limit test)Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw (limit test) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42a33770-acf5-4c71-86a4-d4f6f18cddf8/documents/17511fc4-3c33-490a-bebb-b4c936a6e8a5_3f6c7eb6-3148-406f-bec0-7236e064a6a9.html,,,,,, "N-{2-[(4,6-dimethoxy-1,3,5-triazin-2-yl)carbonyl]-6-fluorophenyl}-1,1-difluoro-N-methylmethanesulfonamide",874195-61-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42a33770-acf5-4c71-86a4-d4f6f18cddf8/documents/17511fc4-3c33-490a-bebb-b4c936a6e8a5_3f6c7eb6-3148-406f-bec0-7236e064a6a9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N-{2-[(4,6-dimethoxy-1,3,5-triazin-2-yl)carbonyl]-6-fluorophenyl}-1,1-difluoro-N-methylmethanesulfonamide",874195-61-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42a33770-acf5-4c71-86a4-d4f6f18cddf8/documents/17511fc4-3c33-490a-bebb-b4c936a6e8a5_3f6c7eb6-3148-406f-bec0-7236e064a6a9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N-{2-[(4,6-dimethoxy-1,3,5-triazin-2-yl)carbonyl]-6-fluorophenyl}-1,1-difluoro-N-methylmethanesulfonamide",874195-61-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42a33770-acf5-4c71-86a4-d4f6f18cddf8/documents/17511fc4-3c33-490a-bebb-b4c936a6e8a5_3f6c7eb6-3148-406f-bec0-7236e064a6a9.html,,inhalation,LC50,"5,297.5 mg/m3",no adverse effect observed, "N-[4-[[(1-methylethyl)amino]acetyl]phenyl]-, monohydrochloride",5576-49-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0440e16a-bcbd-4e89-9083-8474a009f7c8/documents/b12d2e70-3d66-47b6-89f8-ca8e1d5f9a98_ef774d1f-f048-432c-80d0-e600d3018d96.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Methansulfonic acid (1,6-hexanediyl-diimino)bis[1-oxo, disodium salt",38632-47-2,In a comprehensive sub-chronic oral gavage toxicity study in rats conducted according to OECD TG 408 and GLP the NOAEL was reported to be 278 mg/kg. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/baa5561b-6f36-4cd7-bb37-a0325e0e5a0e/documents/IUC5-7baebb23-421b-474c-b948-c7c20b29a4a0_65db8051-6341-46d6-9a11-8b44d80c4d72.html,,,,,, "Methansulfonic acid (1,6-hexanediyl-diimino)bis[1-oxo, disodium salt",38632-47-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/baa5561b-6f36-4cd7-bb37-a0325e0e5a0e/documents/IUC5-7baebb23-421b-474c-b948-c7c20b29a4a0_65db8051-6341-46d6-9a11-8b44d80c4d72.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,278 mg/kg bw/day,,rat "Methansulfonic acid (1,6-hexanediyl-diimino)bis[1-oxo, disodium salt",38632-47-2,"An acute oral toxicity study according OECD TG 423 was conducted. Two x three female rats received a single dose of X-TAN (preparation of hexamethylen diisocyanatebisulfite-adducte in water). Up to 2000 mg/kg of a 31% X-Tan solution was tested. No mortalities or clinical signs were observed.An acute inhalation toxicity test acording OECD 403 was conducted with rats to determine the potential for the aerosolized dust of 1,1' -(1 ,6-Hexanediyldiimino)bis[l-oxo-methanesulfonic acid], sodium salt (1 :2) to produce toxicity via the inhalation (nose-only exposure) route.In an acute dermal toxicity study according OECD 402 five male and five female RccHan:WIST (SPF) rats were treated with 1,1’-(1,6- Hexanediyldiimono)bis[1-oxo-methanesulfonic acid], sodium salt (1:2) at the limit dose of 2000 mg/kg by dermal application. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/baa5561b-6f36-4cd7-bb37-a0325e0e5a0e/documents/IUC5-5db014f5-cb00-494a-affb-7e02a86cdd7f_65db8051-6341-46d6-9a11-8b44d80c4d72.html,,,,,, Methanesulphonic acid,75-75-2,"Inhalation:  OECD Guideline 412 (Repeated Dose Inhalation Toxicity: 28/14-Day), no adverse systemic effects, NOAEC (systemic effects) >= 0.242 mg/L ,  LOAEC (local irritation) = 0.026 mg/L (ElfAtochem 1996) Oral: OECD Guideline 408 (Repeated Dose Oral Toxicity: 90d), pH 3, no adverse systemic effects, NOAEL > 1000 mg/kg bw/d (BASF SE, 2023) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c5208108-89fd-42a7-9b8a-7494696e3dce/documents/IUC5-4e351fce-6694-4a9e-87d0-d814978539f0_b2c06237-bbe4-461e-b3fc-9b3d058f5a5e.html,,,,,, Methanesulphonic acid,75-75-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c5208108-89fd-42a7-9b8a-7494696e3dce/documents/IUC5-4e351fce-6694-4a9e-87d0-d814978539f0_b2c06237-bbe4-461e-b3fc-9b3d058f5a5e.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,26 mg/m3,,rat Methanesulphonic acid,75-75-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c5208108-89fd-42a7-9b8a-7494696e3dce/documents/IUC5-4e351fce-6694-4a9e-87d0-d814978539f0_b2c06237-bbe4-461e-b3fc-9b3d058f5a5e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"> 1,000 mg/kg bw/day",,rat Methanesulphonic acid,75-75-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c5208108-89fd-42a7-9b8a-7494696e3dce/documents/IUC5-6ee6e0f9-249a-4543-aacc-06990f3abbfb_b2c06237-bbe4-461e-b3fc-9b3d058f5a5e.html,,oral,LD50,"1,157.5 mg/kg bw",adverse effect observed, Methanesulphonyl chloride,124-63-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d6a2b83-2b99-4ae8-a6e2-c8f43035c96f/documents/IUC5-68d0176f-bf1b-4710-bdc8-1d289842fb94_ac83c247-aca1-4c23-ba88-38ef1af6f302.html,,oral,LD50,255 mg/kg bw,, Methanesulphonyl chloride,124-63-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d6a2b83-2b99-4ae8-a6e2-c8f43035c96f/documents/IUC5-68d0176f-bf1b-4710-bdc8-1d289842fb94_ac83c247-aca1-4c23-ba88-38ef1af6f302.html,,inhalation,LC50,117.7 mg/m3,, Methanetrisulphonic acid,54322-33-7, Acute oral toxicity: LD50 was estimated to be 4547 mg/kg bw when male and female rats were orally exposed with methanetrisulfonic acid. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78554e5c-3c01-4b9e-b2df-532cb47d5408/documents/a5c03db4-eeb0-4a33-8a98-185311b47447_0eebeaff-aca0-46c7-92f6-0a431b8466fc.html,,,,,, Methanetrisulphonic acid,54322-33-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78554e5c-3c01-4b9e-b2df-532cb47d5408/documents/a5c03db4-eeb0-4a33-8a98-185311b47447_0eebeaff-aca0-46c7-92f6-0a431b8466fc.html,,oral,LD50,"4,547 mg/kg bw",no adverse effect observed, "1,4-phenylene bis[(4-phenoxyphenyl)-methanone]",54299-17-1," Repeated dose toxicity: via oral route; NOAEL was in the dose rang of 190-1000 mg/kg bw for test chemical when exposed orally to test animals. Repeated inhalation study: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 1,4-phenylene bis[(4-phenoxyphenyl)-methanone]; [4-(4-phenoxybenzoyl)phenyl](4-phenoxyphenyl)methanone (54299-17-1) which is reported as 0.0063680238mmHg at 25 C. Also considering the particle size distribution of the substance the majority of the particles was found to be in the size of 150 micron to 25 micron which is much larger size range compared to the inhalable particulate matter .Thus, exposure to inhalable dust, mist and vapour of the chemical 1,4-phenylene bis[(4-phenoxyphenyl)-methanone]; [4-(4-phenoxybenzoyl)phenyl](4-phenoxyphenyl)methanone is highly unlikely. Therefore this study is considered for waiver. Repeated dermal study; The acute toxicity value for 1,4-phenylene bis[(4-phenoxyphenyl)-methanone]; [4-(4-phenoxybenzoyl)phenyl](4-phenoxyphenyl)methanone (54299-17-1) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 1,4-phenylene bis[(4-phenoxyphenyl)-methanone]; [4-(4-phenoxybenzoyl)phenyl](4-phenoxyphenyl)methanone shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests 1,4-phenylene bis[(4-phenoxyphenyl)-methanone]; [4-(4-phenoxybenzoyl)phenyl](4-phenoxyphenyl)methanone shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60840dec-35df-4db2-ad87-7bafdc6ce41c/documents/7d5a63c9-cf9e-468e-9f90-ce394d089f03_8b0bbf35-a7a6-4f5f-a611-883984b9af41.html,,,,,, "1,4-phenylene bis[(4-phenoxyphenyl)-methanone]",54299-17-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60840dec-35df-4db2-ad87-7bafdc6ce41c/documents/7d5a63c9-cf9e-468e-9f90-ce394d089f03_8b0bbf35-a7a6-4f5f-a611-883984b9af41.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,4-phenylene bis[(4-phenoxyphenyl)-methanone]",54299-17-1," Acute oral Toxicity:  The acute oral toxicity dose (LD50) for target chemical 1,4-phenylene bis[(4-phenoxyphenyl)-methanone] (CAS no.: 54299-17-1) was estimated based on QSAR prediction done using the Danish (Q)SAR Database. The LD50 value was estimated to be 1500 mg/kg bw in rats. The study concluded that the LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, 1,4-phenylene bis[(4-phenoxyphenyl)-methanone] can be classified in “Category 4” for acute oral toxicity.  Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test substance 1,4-phenylene bis[(4-phenoxyphenyl)-methanone] (CAS no.: 54299-17-1), which is reported to be 6.37E-14 mmHg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver. Acute dermal Toxicity:  The acute dermal toxicity dose (LD50) for target chemical 1,4-phenylene bis[(4-phenoxyphenyl)-methanone] (CAS no.: 54299-17-1) was considered based on data available for the structurally and functionally similar read across chemicals. The LD50 value was considered to be >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 1,4-phenylene bis[(4-phenoxyphenyl)-methanone] cannot be classified for acute dermal toxicity.  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60840dec-35df-4db2-ad87-7bafdc6ce41c/documents/7f83b36c-be47-404e-8204-c2ceea0760bb_8b0bbf35-a7a6-4f5f-a611-883984b9af41.html,,,,,, "1,4-phenylene bis[(4-phenoxyphenyl)-methanone]",54299-17-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60840dec-35df-4db2-ad87-7bafdc6ce41c/documents/7f83b36c-be47-404e-8204-c2ceea0760bb_8b0bbf35-a7a6-4f5f-a611-883984b9af41.html,,oral,LD50,"1,500 mg/kg bw",adverse effect observed, "1,4-phenylene bis[(4-phenoxyphenyl)-methanone]",54299-17-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60840dec-35df-4db2-ad87-7bafdc6ce41c/documents/7f83b36c-be47-404e-8204-c2ceea0760bb_8b0bbf35-a7a6-4f5f-a611-883984b9af41.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Methomyl,16752-77-5," Study Type Species Findings  Guideline Reliability  Oral 90-day Feed  Rat  LOAEL 540 ppm (body weight effects); 200/270 ppm (effects on hemoglobin)   no guideline 2 Oral 90-day Feed  Rat  LOAEL: 500/125 ppm (effects on body weight) no guideline 2 Oral 90-day Feed  Mice LOAEL: 150 ppm (effects on hemoglobin) no guideline  2 Oral 2-year Feed  Dog  LOAEL: 400 ppm (pathology effects in kidney, spleen, liver, bone marrow)  no guideline 2 Oral 104-Week Feed  Mice LOAEL 100/75 ppm effects on hematocrit, hemoglobin, and red blood cells. no guideline 2 Oral 2-Year Feed  Rat  LOAEL: 400 ppm effects on hematocrit, hemoglobin, and red blood cells. no guideline 2  Oral 22-Month Feed   Rat LOAEL: 200 ppm body weight and food consumption effects, relative testes effects, pathology findings in spleen and kidney no guideline 2 21-Day Dermal Rabbit  LOAEL: 50 mg/kg/d effects on plasma and brain cholinesterase activities OECD 410, EPA OPP 82-2  1 21-Day Dermal Rabbit  LOAEL: > 90 mg/kg/d (highest level tested) EPA OPP 82-2  1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/842050c1-d6d7-46ed-9751-811c3d491776/documents/40251f48-bbee-4631-9f05-82870d4ed802_f53d98f1-736a-43cf-b5e9-e1d4a12bca99.html,,,,,, Methomyl,16752-77-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/842050c1-d6d7-46ed-9751-811c3d491776/documents/40251f48-bbee-4631-9f05-82870d4ed802_f53d98f1-736a-43cf-b5e9-e1d4a12bca99.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,50 mg/kg bw/day,,rabbit Methomyl,16752-77-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/842050c1-d6d7-46ed-9751-811c3d491776/documents/40251f48-bbee-4631-9f05-82870d4ed802_f53d98f1-736a-43cf-b5e9-e1d4a12bca99.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,3.6 mg/kg bw/day,,rat Methomyl,16752-77-5," Duration/Value Type  Species Value  Guideline Reliability    Oral LD50 Rat, female  17.98 mg/kg  OECD 425, EPA OPPTS 870.1100 1   Oral LD50 Rat, male/female   32 mg/kg EPA OPP 81-1  1  Oral Lethal Dose Dog   20 mg/kg no guideline  2  Oral Minimum Lethal Dose rabbit   30 mg/kg no guideline  2  Oral Minimum Lethal Dose guinea pig   15 mg/kg no guideline  2  Oral LD50 Adult hen   28 mg/kg no guideline  2 Duration/Value Type  Species Value  Guideline Reliability  Inhalation 4 -hr LC50 Rat, male/female 0.258 mg/L  OECD 403, EPA OPP 81-3, MAFF Testing Guideline for Acute Inhalation Toxicity Study (59 NohSan No. 4200)  1   Inhalation 4 -hr LC50 Rat 0.28 - 0.30 mg/L no guideline  2 Duration/Value Type  Species Value  Guideline Reliability  Dermal LD50 Rat > 5000 mg/kg  OECD 402, OPPTS 870.1200, Ministry of Agriculture, Forestry and Fisheries of Japan 12-Nouan-8147 1   Dermal LD50 Rabbit > 5000 mg/kg no guideline  2 Dermal LD50 Rabbit > 2000 mg/kg EPA 81-2 1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/842050c1-d6d7-46ed-9751-811c3d491776/documents/290fb48f-ea30-4501-ab3a-59318e9816f3_f53d98f1-736a-43cf-b5e9-e1d4a12bca99.html,,,,,, Methomyl,16752-77-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/842050c1-d6d7-46ed-9751-811c3d491776/documents/290fb48f-ea30-4501-ab3a-59318e9816f3_f53d98f1-736a-43cf-b5e9-e1d4a12bca99.html,,oral,LD50,17.98 mg/kg bw,adverse effect observed, Methomyl,16752-77-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/842050c1-d6d7-46ed-9751-811c3d491776/documents/290fb48f-ea30-4501-ab3a-59318e9816f3_f53d98f1-736a-43cf-b5e9-e1d4a12bca99.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Methomyl,16752-77-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/842050c1-d6d7-46ed-9751-811c3d491776/documents/290fb48f-ea30-4501-ab3a-59318e9816f3_f53d98f1-736a-43cf-b5e9-e1d4a12bca99.html,,inhalation,LC50,258 mg/m3,adverse effect observed, Methoxyammonium chloride,593-56-6,"No reliable data are available for the test substance. The toxicological assessment is based on read-across to CAS 10039-54-0. NOAEL = 0.9 mg/kg bw/d; 90 d, rat, oral (similar to OECD 408, GLP, reliability 2)  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The quality of the whole database is high. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9164e9aa-bfee-42d7-a26f-fdc5e73841ef/documents/5cd8ceb6-fba0-4381-96d0-0a9078425723_a680651d-0b4e-4234-8607-85fdfe7ecce6.html,,,,,, Methoxyammonium chloride,593-56-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9164e9aa-bfee-42d7-a26f-fdc5e73841ef/documents/5cd8ceb6-fba0-4381-96d0-0a9078425723_a680651d-0b4e-4234-8607-85fdfe7ecce6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.9 mg/kg bw/day,,rat Methoxyammonium chloride,593-56-6,"No reliable data for the test substance do exist. The toxicological assessment is based on the available data of CAS 10039-54-0. Oral: LD50 = 642 mg/kg bw, rat, oral; similar to OECD TG 401, non-GLP, reliability 2 Inhalation: no reliable data available Dermal: LD50 > 1500 < 2000 mg/kg bw, rabbit, dermal; similar to OECD TG 402, GLP, reliability 1 Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The quality of the whole dataase is high. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The quality of the whole database is high. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9164e9aa-bfee-42d7-a26f-fdc5e73841ef/documents/013bd25c-bf56-44ee-8f63-9d68f4cd7208_a680651d-0b4e-4234-8607-85fdfe7ecce6.html,,,,,, Methoxyammonium chloride,593-56-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9164e9aa-bfee-42d7-a26f-fdc5e73841ef/documents/013bd25c-bf56-44ee-8f63-9d68f4cd7208_a680651d-0b4e-4234-8607-85fdfe7ecce6.html,,oral,LD50,642 mg/kg bw,adverse effect observed, Methoxyammonium chloride,593-56-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9164e9aa-bfee-42d7-a26f-fdc5e73841ef/documents/013bd25c-bf56-44ee-8f63-9d68f4cd7208_a680651d-0b4e-4234-8607-85fdfe7ecce6.html,,dermal,LD50,"> 1,500 mg/kg bw",adverse effect observed, "methyl (5S)-2,3,4-tri-O-acetyl-5-[4-chloro-3-(4-ethoxybenzyl)phenyl]-1-thio-beta-L-xylopyranoside",1018899-03-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): OECD 423 - LD50 oral rat > 2000 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/897dd1e7-89c4-4392-995b-5e76cd7bc35d/documents/01f016d2-a6c1-4cc2-a7a0-b8233de1fc36_4c0b8919-0a8f-44e6-b64a-73ae59fe8477.html,,,,,, "Methyl (8,9,10-trinorborn-5-en-2-yl) ketone",5063-03-6,"The substance has a reliably predicted acute oral LD50 of 1099 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Quality shows some restrictions as only in silico data are available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb196b47-d62d-4225-ae8b-18a0472c56fc/documents/99af3cc3-56ca-4fef-8321-bba714547610_7701c086-899b-4cd4-adf6-9ed99f386905.html,,,,,, "Methyl (8,9,10-trinorborn-5-en-2-yl) ketone",5063-03-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb196b47-d62d-4225-ae8b-18a0472c56fc/documents/99af3cc3-56ca-4fef-8321-bba714547610_7701c086-899b-4cd4-adf6-9ed99f386905.html,,oral,LD50,"1,099 mg/kg bw",adverse effect observed, Methyl (R)-2-(4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy)propionate,72619-32-0, 16 week rat feeding study NOEL: 0.065 mg/kg/day in males and 0.2 mg/kg/day in females; GLP study; Reliability = 2 1 year rat feeding study NOEL: 0.065 mg/kg/day in both males; GLP study; Reliability = 2 21-day rat dermal study NOAEL > 50 mg/kg/day; OECD 410; Reliability = 1 ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ab5c775-5ed0-45cc-9feb-892f14ed3158/documents/8ff5e83d-2f8a-4f98-9f21-4f23d862c334_b7a30022-61f8-449b-b512-141301847454.html,,,,,, Methyl (R)-2-(4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy)propionate,72619-32-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ab5c775-5ed0-45cc-9feb-892f14ed3158/documents/8ff5e83d-2f8a-4f98-9f21-4f23d862c334_b7a30022-61f8-449b-b512-141301847454.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,50 mg/kg bw/day,,rat Methyl (R)-2-(4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy)propionate,72619-32-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ab5c775-5ed0-45cc-9feb-892f14ed3158/documents/8ff5e83d-2f8a-4f98-9f21-4f23d862c334_b7a30022-61f8-449b-b512-141301847454.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.065 mg/kg bw/day,,rat Methyl (R)-2-(4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy)propionate,72619-32-0," Oral: rat LD50: 300 mg/kg (male), 623 mg/kg (female). EPA Subdivision F, 81-1; Reliability = 1 Inhalation: rat 4-hour LC50: 2.50 mg/L (maximum achievable concentration); OECD 403; Reliability = 1 Dermal: rat LD50: >2000 mg/kg. EPA guideline Subdivision F, 81-2; Reliability = 1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ab5c775-5ed0-45cc-9feb-892f14ed3158/documents/31ec413d-7384-4abe-9c37-a73ef6f4c134_b7a30022-61f8-449b-b512-141301847454.html,,,,,, Methyl (R)-2-(4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy)propionate,72619-32-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ab5c775-5ed0-45cc-9feb-892f14ed3158/documents/31ec413d-7384-4abe-9c37-a73ef6f4c134_b7a30022-61f8-449b-b512-141301847454.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Methyl (R)-2-(4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy)propionate,72619-32-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ab5c775-5ed0-45cc-9feb-892f14ed3158/documents/31ec413d-7384-4abe-9c37-a73ef6f4c134_b7a30022-61f8-449b-b512-141301847454.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl (R)-2-(4-(3-chloro-5-trifluoromethyl-2-pyridyloxy)phenoxy)propionate,72619-32-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ab5c775-5ed0-45cc-9feb-892f14ed3158/documents/31ec413d-7384-4abe-9c37-a73ef6f4c134_b7a30022-61f8-449b-b512-141301847454.html,,inhalation,LC50,"2,500 mg/m3",no adverse effect observed, Methyl (R)-amino(4-hydroxyphenyl)acetate,37763-23-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfd07611-4b12-4c9c-a3a2-6e924933b05a/documents/IUC5-6f8c8f50-8734-4654-8670-d84401a88f4a_ed4d90ab-5eb5-41a2-a8ca-7ddf3db1c528.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate",15546-11-9,"The following studies have been submitted to address the repeated dose toxicity: oral endpoint:Waalkens-Berendsen DH (2003) Dibutyldichlorostannane (CAS # 683-18-1): Reproduction/developmental toxicity screening test in rats, TNO, Project Organisation, Ecotoxicology, Utrechtseweg 48, P.O. Box 370, 3700 AJ Zeist, The Netherlands, Report No.: V 4906, Organotin Environmental Programme (ORTEP) Association, Stabilizer Task Force. Report Date.: 2003-12-04.Barnes, J. M. and Stoner, H. B. (1958). Toxic properties of some dialkyl and trialkyl tin salts. Brit. J. Industr. Med., 1958, 15, 15.Gaunt et al (1968). Acute and Short-term Toxicity Studies on Di-n-butyltin Dichloride in Rats. Fd Cosmet. Toxicol. Vol. 6, pp. 599-608.Penninks A. H. & Seinen W. (1982). COMPARATIVE TOXICITY OF ALKYLTIN AND ESTERTIN STABILIZERS. Fd Chem. Toxic. Vol. 20. pp. 909 to 916.The Gaunt et al (1968) study has been allocated a Klimisch core of 2 on the basis that the study predates GLP; however, method was comparable to OECD Guideline 408. The effect of DBT exposure on the thymus of was not assessed in this study. No information on the stability or homogeneity of the test material in the DBTC-prepared diets. The study was performed with dibutyltin dichloride.The Penninks and Seinen (1982) study has also been allocated a Klimisch score of 2 on the basis that the study is a short-term feeding study with no information on the stability of the test substance in the diet or homogeneity of the test diets provided. The purity of the test substance (dibutyltin dichloride) is not reported. The Barnes and Stoner (1958) study has been allocated a Klimisch score of 4.Dibutyltin chloride was the test substance employed in all the studies presented under repeated dose toxicity. Under gastric conditions, the substance in question is anticipated to hydrolyse to dibutyltin chloride. A read-across approach from dibutyltin chloride was considered acceptable when dosing repeatedly via the oral route. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c78a0b2-45aa-45b0-a7a3-46fca3f397a3/documents/IUC5-b779a979-8ec1-441d-beb2-4d7ef81efae8_56d5ad3c-d7ca-4ba3-9b96-a5283eec5379.html,,,,,, "Methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate",15546-11-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c78a0b2-45aa-45b0-a7a3-46fca3f397a3/documents/IUC5-b779a979-8ec1-441d-beb2-4d7ef81efae8_56d5ad3c-d7ca-4ba3-9b96-a5283eec5379.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.3 mg/kg bw/day,,rat "Methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate",15546-11-9,"The following key studies were submitted to fulfil the acute toxicity data requirement:Oral:In an acute oral toxicity study equivalent to OECD Guideline No. 401, groups of 10 young adult Sprague-Dawley rats/sex were given a single oral dose of the test item Prosper MSL (96 % Methyl-(Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oat) in vegetable oil at doses of 0 (vehicle control), 100, 200, 400, 800, and 1600 mg/kg bw and observed for 14 days.Oral LD50 Females: 419 mg/kg bw (95% C.L. 229.78 to 764.46 mg/kg bw)Oral LD50 Males: 526 mg/kg bw (95% C.L. 319.59 to 866.74 mg/kg bw)Treatment related clinical signs were lethargy, motor incoordination, altered faeces consistency, nosebleeding and body weight retardation. There were no treatment related necropsy findings in animals found dead within the observation period or sacrificed at study termination.Methyl-(Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oat is of moderate toxicity based on the oral LD50 of 526 and 419 mg/kg bw in male and female rats, respectively.Dermal:The acute dermal LD50 of the test material is in the range of 5000 mg/kg bw, as within one week of observation 3/5 males and 2/5 females died after application of this dose, whereas none of the animals treated with 2500 mg/kg bw . The whole treated area of the skin became necrotic and started to slough off seven days after the application of the test material. To avoid unnecessary suffering the experiment was therefore terminated after one instead of two weeks. After treatment a heavy weight loss was also observed.Inhalation: As the substance is known to be corrosive to the skin, it is considered justified to omit further testing in the interest of animal welfare. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c78a0b2-45aa-45b0-a7a3-46fca3f397a3/documents/IUC5-453054c4-5f2d-4cdc-9b0b-d31ddccf20bc_56d5ad3c-d7ca-4ba3-9b96-a5283eec5379.html,,,,,, "Methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate",15546-11-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c78a0b2-45aa-45b0-a7a3-46fca3f397a3/documents/IUC5-453054c4-5f2d-4cdc-9b0b-d31ddccf20bc_56d5ad3c-d7ca-4ba3-9b96-a5283eec5379.html,,oral,LD50,419 mg/kg bw,, "Methyl (Z,Z)-8,8-dibutyl-3,6,10-trioxo-2,7,9-trioxa-8-stannatrideca-4,11-dien-13-oate",15546-11-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c78a0b2-45aa-45b0-a7a3-46fca3f397a3/documents/IUC5-453054c4-5f2d-4cdc-9b0b-d31ddccf20bc_56d5ad3c-d7ca-4ba3-9b96-a5283eec5379.html,,dermal,LD50,"5,000 mg/kg bw",, Methyl [[(methoxycarbonyl)amino](methylthio)methylene]carbamate,34840-23-8,"Acute Oral toxicity study in male and female Wistar rats Testing facility: Bayer Industry Services, LeverkusenStudy no. T2070311 performed on April 3, 2001. The registrant has a Letter of Access. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4c1e21e-a0b4-409e-85c1-7e412bd5c0d9/documents/IUC5-b1c7dad8-30f7-4b84-858e-d01e551d4109_4b860da3-5893-4330-870c-9ece7ceb7e24.html,,,,,, Methyl [3-(trimethoxysilyl)propyl]carbamate,23432-62-4, RDT oral (OECD 408): NOAEL = 100 mg/kg bw/day for females; NOAEL for males could not be established RDT inhalation: no data available RDT dermal: no data available ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58232ba2-2095-45d6-8a82-4f5074cdc642/documents/8dcfe2c7-8370-418b-ae47-b234a11bf371_2eddafbf-d6f2-4404-aa1e-845d7f54be5b.html,,,,,, Methyl [3-(trimethoxysilyl)propyl]carbamate,23432-62-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/58232ba2-2095-45d6-8a82-4f5074cdc642/documents/8dcfe2c7-8370-418b-ae47-b234a11bf371_2eddafbf-d6f2-4404-aa1e-845d7f54be5b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Methyl [3-(trimethoxysilyl)propyl]carbamate,23432-62-4,"Acute oral toxicity (OECD 423, rat): LD50>2000 mg/kg bwAcute inhalation toxicity: no data availableAcute dermal toxicity (weight of evidence):CAS 23432-64-6 (OECD 402, rat): LD50>2000 mg/kg bwCAS 23432-65-7 (OECD 402, rat): LD50>2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58232ba2-2095-45d6-8a82-4f5074cdc642/documents/135782b5-124c-441c-a388-b39674821e1a_2eddafbf-d6f2-4404-aa1e-845d7f54be5b.html,,,,,, Methyl 2-((allyloxy)methyl)acrylate,219828-90-7,"Acute toxicity, oral, (rat): 300 mg/kg bodyweight < LD50 < 2000 mg/kg bodyweight Acute toxicity, inhalation, (rat): LC50 1.087mg a.i/L air ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/155c8dbe-45a6-44f5-9c86-36e71a7b3074/documents/4b1e7f4c-c751-4038-bc91-e423d56a8548_c43fbe81-260f-4fa4-b9fb-5234d1033c11.html,,,,,, "Methyl 2,3-dichloropropionate",3674-09-7, Experimental data (acute oral and dermal toxicity tests) on this property are available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40464fab-ecaf-4dbf-bfec-5fbc9ed05838/documents/e247e09a-1e05-4f51-93c0-ccfaa97e92e7_ddb35dd2-4916-421e-924d-09fc80072bea.html,,,,,, "Methyl 2,3-dichloropropionate",3674-09-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40464fab-ecaf-4dbf-bfec-5fbc9ed05838/documents/e247e09a-1e05-4f51-93c0-ccfaa97e92e7_ddb35dd2-4916-421e-924d-09fc80072bea.html,,oral,LD50,270 mg/kg bw,adverse effect observed, "Methyl 2,3-dichloropropionate",3674-09-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40464fab-ecaf-4dbf-bfec-5fbc9ed05838/documents/e247e09a-1e05-4f51-93c0-ccfaa97e92e7_ddb35dd2-4916-421e-924d-09fc80072bea.html,,dermal,LD50,"3,680 mg/kg bw",no adverse effect observed, "Methyl 2-[(1,5-dihydro-3-methyl-5-oxo-1-phenyl-4H-pyrazol-4-ylidene)ethylidene]-1,3,3-trimethylindoline-5-carboxylate",5718-26-3,"Short-term repeated dose toxicity: OECD 407, GLP, oral gavage, rats, 28 days, Doses: 250, 500 or 1000 mg/kg bw/day, Result: NOAEL: 1000 mg/kg bw/day.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2bc8370d-1b79-4ab3-b255-f041f8495596/documents/9f92b322-e460-4fb6-9137-520ea2cfb617_c784549e-9806-4eb6-97f6-94d23f902ddf.html,,,,,, "Methyl 2-[(1,5-dihydro-3-methyl-5-oxo-1-phenyl-4H-pyrazol-4-ylidene)ethylidene]-1,3,3-trimethylindoline-5-carboxylate",5718-26-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2bc8370d-1b79-4ab3-b255-f041f8495596/documents/9f92b322-e460-4fb6-9137-520ea2cfb617_c784549e-9806-4eb6-97f6-94d23f902ddf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Methyl 2-[(1,5-dihydro-3-methyl-5-oxo-1-phenyl-4H-pyrazol-4-ylidene)ethylidene]-1,3,3-trimethylindoline-5-carboxylate",5718-26-3,"Acute oral toxicity: Similar to OECD TG 401, non-GLP, limit test: 5000 mg/kg bw, 5 rats/sex, Results: LD50: > 5000 mg/kg bw.   Acute inhalation toxicity: OECD TG 403, GLP, limit test: 2441 mg/m3, 3 rats/sex, Results: LC50: > 2441 mg/m³.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bc8370d-1b79-4ab3-b255-f041f8495596/documents/4a593ac5-0825-4586-9668-b4c94dcc9cae_c784549e-9806-4eb6-97f6-94d23f902ddf.html,,,,,, "Methyl 2-[(1,5-dihydro-3-methyl-5-oxo-1-phenyl-4H-pyrazol-4-ylidene)ethylidene]-1,3,3-trimethylindoline-5-carboxylate",5718-26-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bc8370d-1b79-4ab3-b255-f041f8495596/documents/4a593ac5-0825-4586-9668-b4c94dcc9cae_c784549e-9806-4eb6-97f6-94d23f902ddf.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "Methyl 2-[(1,5-dihydro-3-methyl-5-oxo-1-phenyl-4H-pyrazol-4-ylidene)ethylidene]-1,3,3-trimethylindoline-5-carboxylate",5718-26-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bc8370d-1b79-4ab3-b255-f041f8495596/documents/4a593ac5-0825-4586-9668-b4c94dcc9cae_c784549e-9806-4eb6-97f6-94d23f902ddf.html,,inhalation,LC50,"> 2,441 mg/m3",no adverse effect observed, "Methyl 2-amino-4-[[(2,5-dichlorophenyl)amino]carbonyl]benzoate",59673-82-4,Single oral application of 1260 mg/kg bw did not cause toxicity or lethality in rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3925f41e-c505-4178-bfcc-1b38f24266df/documents/IUC5-6d68750b-dd5c-4d76-b684-75c17972bed5_1359e7d6-0279-49db-8971-a111f64d4e00.html,,,,,, Methyl 2-benzoylbenzoate,606-28-0," Repeated daily administration of RCX 14-672 by oral gavage to Wistar rats at dose levels of 31.25, 125, or 500 mg/kg bw/day during the treatment period under the conditions of this study did not result in test item related mortality, clinical adverse effects, or changes in neurological assessment, body weight, food consumption, haematology, coagulation or urinalysis parameters. In clinical chemistry analysis, the albumin concentration was higher than the control in both sexes (by ~11% at the high dose). Consequently, total protein concentration was also higher and attained statistical significance in both high dose male and female treated groups. These changes could be associated with the organ weight changes and the microscopic liver findings. Test item related differences were found in liver and kidney weights at 500 mg/kg bw/day in both sexes and at 125 mg/kg bw/day in males, in correlation with the histopathological changes. The test item administration was associated with hepatocellular hypertrophy of the liver, and degeneration in the cortical/corticomedullary tubules of the kidney in the mid and the high dose in both sexes. The incidence and severity suggested dose relationship in both alterations. Hypertrophy occurred in the liver with centrilobular zonation, minimal and mild severity in both sexes at the high dose, and with minimal intensity in the mid dose males. This change was regarded as non-adverse adaptive response. No hypertrophy was observed in the mid and low dose females and in the low dose males. No hypertrophy was observed in the mid and low dose females and in the low dose males. In the kidney, test item related degeneration altered tubules were noted in high dose animals with minimal to mild intensity and mainly bilateral distribution, in one mid dose male and one mid dose female as unilateral with minimal intensity. There was no evidence of tubule degeneration in the kidneys at the low dose level. In conclusion, under the conditions of this study, the no observed adverse effect level (NOAEL) for RCX 14-672 is considered to be 31.25 mg/kg bw/day for the parental/adult generation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/369735ff-1e82-4c77-9be6-0217f188e88e/documents/IUC5-2dc743f2-e11b-4f34-bca7-c50ca0a49717_c52bebef-ad07-4d3b-ba9f-4f28958bb84d.html,,,,,, Methyl 2-benzoylbenzoate,606-28-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/369735ff-1e82-4c77-9be6-0217f188e88e/documents/IUC5-2dc743f2-e11b-4f34-bca7-c50ca0a49717_c52bebef-ad07-4d3b-ba9f-4f28958bb84d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,31.25 mg/kg bw/day,,rat Methyl 2-benzoylbenzoate,606-28-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/369735ff-1e82-4c77-9be6-0217f188e88e/documents/IUC5-9f869dcd-ab09-4e8a-9db1-6a84b8a6af5a_c52bebef-ad07-4d3b-ba9f-4f28958bb84d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Methyl 2-benzoylbenzoate,606-28-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/369735ff-1e82-4c77-9be6-0217f188e88e/documents/IUC5-9f869dcd-ab09-4e8a-9db1-6a84b8a6af5a_c52bebef-ad07-4d3b-ba9f-4f28958bb84d.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Methyl 2-ethylhexanoate,816-19-3,"Oral: LD50= > 2000 mg/kg bw, female rat, OECD 425, Product Safety Laboratories 2003 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c8b1978-a1f0-468e-b22a-349f941c0ec5/documents/IUC5-36eec161-19e2-4f8f-8e69-4a330c07644a_bfe76ac2-238d-4101-ad3b-13800b813b84.html,,,,,, Methyl 2-hydroxy-2-methylpropionate,2110-78-3," Acute oral toxicity study in rats (OECD Guideline 401): LD50 = 2,000-5,000 mg/kg in both males and females. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ca40bb3-adf9-4a5d-a752-f8bcfd3ccd8d/documents/24d8efa7-1c76-4c98-9a62-0c2a4afe722e_ae604b5d-1f84-4c9b-a01f-71fb294a88a8.html,,,,,, Methyl 2-hydroxy-2-methylpropionate,2110-78-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ca40bb3-adf9-4a5d-a752-f8bcfd3ccd8d/documents/24d8efa7-1c76-4c98-9a62-0c2a4afe722e_ae604b5d-1f84-4c9b-a01f-71fb294a88a8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, methyl 2-hydroxybut-3-enoate,5837-73-0,"The tests were conducted with the purified and stabilised (registered) form of the test substance.    In a 14-day oral range-finding study in male and female Wistar rats, the dose levels for a Combined Repeated Dose Toxicity Study with the Reproduction/ Developmental Toxicity Screening Test (main study) were chosen as 0, 20, 50 and 100 mg/kg bw/day based on dose-dependent test item related local effects in the stomach.   In a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to OECD guideline 422, the test item administered at 20, 50 and 100 mg/kg bw/day by oral gavage did not adversely influence the reproductive performance (gonad function, mating behavior, conception, parturition) and did not cause systemic toxicity in parental male and female Han:WIST rats. Local effects were detected macroscopically and microscopically in the forestomach in male and female animals at 50 and 100 mg/kg bw/day. This local gastric effect did not induce clear adverse systemic changes although early signs (slight effects on body weight, food consumption, salivation) were noted. Therefore, a NOEL/NOAEC was deduced in addition to the NOAEL. Based on these observations the No Observed Adverse Effect Levels (NOAEL), No Observed Effect Level (NOEL) and No Observed Adverse Effective Concentration (NOAEC) were determined as follows: NOAEL for systemic toxicity of male/ female rats: 100 mg/kg bw/dayNOEL for systemic toxicity of male/ female rats: 20 mg/kg bw/dayNOAEL for reproductive performance of male/ female rats: 100 mg/kg bw/dayNOAEC (local effects stomach): 4 mg/mL Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Reliable without restrictions (RL1) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a483240b-9a14-45b4-a477-09ab7a9d2042/documents/436b26a4-7c95-4798-b750-142f0496d34f_5c7bc2bd-ddd9-478a-aaf0-7ad639d76d59.html,,,,,, methyl 2-hydroxybut-3-enoate,5837-73-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a483240b-9a14-45b4-a477-09ab7a9d2042/documents/436b26a4-7c95-4798-b750-142f0496d34f_5c7bc2bd-ddd9-478a-aaf0-7ad639d76d59.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat methyl 2-hydroxybut-3-enoate,5837-73-0,"The tests were conducted with the purified and stabilised (registered) form of the test substance.    In an acute oral toxicity test according to OECD guideline 423, the LD50 of the test item was found to be between 300 and 2000 mg/kg bw (LD50 cut-off: 500 mg/kg bw).   In an acute dermal toxicity study according to OECD guideline 402 and GLP, the test item could not be classified into any toxicity category as delayed local corrosive effects occured.   On this basis, the test item was classified as corrosive to skin and further acute dermal or inhalation toxicity testing was waived. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable without restrictions ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a483240b-9a14-45b4-a477-09ab7a9d2042/documents/a2d0c8dd-db19-4217-ad31-511dc0f8064b_5c7bc2bd-ddd9-478a-aaf0-7ad639d76d59.html,,,,,, methyl 2-hydroxybut-3-enoate,5837-73-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a483240b-9a14-45b4-a477-09ab7a9d2042/documents/a2d0c8dd-db19-4217-ad31-511dc0f8064b_5c7bc2bd-ddd9-478a-aaf0-7ad639d76d59.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Methyl 3-aminocrotonate,14205-39-1,"Acute Oral Toxicity (Rat-Wistar, non-GLP): LD50 = 1760 mg/kg [Bayer AG, Report dated 1983-06-30] Acute Inhalative Toxicity (Rat-Wistar, non-GLP): LC50 > 23 mg/m³ [Bayer AG, Report No. 11752, 1983-04-27]   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch Score 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Klimisch Score 2 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac13a1d3-2de5-4e3f-8a60-db88b6aa7a9c/documents/IUC5-8dde9ecc-47d6-4bea-9283-4a7e34ea5e8f_af4a7a03-b700-456a-8676-a0e870347e4f.html,,,,,, Methyl 3-aminocrotonate,14205-39-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac13a1d3-2de5-4e3f-8a60-db88b6aa7a9c/documents/IUC5-8dde9ecc-47d6-4bea-9283-4a7e34ea5e8f_af4a7a03-b700-456a-8676-a0e870347e4f.html,,oral,LD50,"1,760 mg/kg bw",adverse effect observed, Methyl 3-aminocrotonate,14205-39-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac13a1d3-2de5-4e3f-8a60-db88b6aa7a9c/documents/IUC5-8dde9ecc-47d6-4bea-9283-4a7e34ea5e8f_af4a7a03-b700-456a-8676-a0e870347e4f.html,,inhalation,LC50,> 23 mg/m3,no adverse effect observed, Methyl 3-mercaptopropionate,2935-90-2,An appropriate oral repeated dose toxicity study is available in methods comparable to OECD guideline 407. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/991afb37-3686-4756-ba90-23ff16aaabc0/documents/IUC5-66b6cb3d-1c04-42bf-89fa-a51dba9eb88b_07117733-6b4c-429c-9c03-2b61989322b7.html,,,,,, Methyl 3-mercaptopropionate,2935-90-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/991afb37-3686-4756-ba90-23ff16aaabc0/documents/IUC5-66b6cb3d-1c04-42bf-89fa-a51dba9eb88b_07117733-6b4c-429c-9c03-2b61989322b7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Methyl 3-mercaptopropionate,2935-90-2,"Appropriate acute toxicity studies are available according to OECD guidelines 401, 402 and 403 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/991afb37-3686-4756-ba90-23ff16aaabc0/documents/IUC5-950a5843-dac4-4ad0-b3d7-3f1ac2b16570_07117733-6b4c-429c-9c03-2b61989322b7.html,,,,,, Methyl 3-mercaptopropionate,2935-90-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/991afb37-3686-4756-ba90-23ff16aaabc0/documents/IUC5-950a5843-dac4-4ad0-b3d7-3f1ac2b16570_07117733-6b4c-429c-9c03-2b61989322b7.html,,oral,LD50,193.6 mg/kg bw,, Methyl 3-mercaptopropionate,2935-90-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/991afb37-3686-4756-ba90-23ff16aaabc0/documents/IUC5-950a5843-dac4-4ad0-b3d7-3f1ac2b16570_07117733-6b4c-429c-9c03-2b61989322b7.html,,dermal,LD50,"1,903.7 mg/kg bw",, Methyl 3-mercaptopropionate,2935-90-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/991afb37-3686-4756-ba90-23ff16aaabc0/documents/IUC5-950a5843-dac4-4ad0-b3d7-3f1ac2b16570_07117733-6b4c-429c-9c03-2b61989322b7.html,,inhalation,LC50,"1,800 mg/m3",, Methyl 3-pyridyl ketone,350-03-8,"Repeated Dose Toxicity – sub-acute: OECD TG 422, GLP, oral, rat, m (29-35 days)/ f (51-67 days), Results: NOAEL: 32.5 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/490b9301-15b8-47d5-9321-740dbad2355f/documents/ebae20d4-92ff-44fb-b277-ba2c153af288_ff451f58-79ec-40c6-84c6-f575106576cb.html,,,,,, Methyl 3-pyridyl ketone,350-03-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/490b9301-15b8-47d5-9321-740dbad2355f/documents/ebae20d4-92ff-44fb-b277-ba2c153af288_ff451f58-79ec-40c6-84c6-f575106576cb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,32.5 mg/kg bw/day,,rat Methyl 3-pyridyl ketone,350-03-8,"Acute Toxicity oral: acute oral gavage study, Sprague-Dawley rats, m/f, 0.0312 mL/kg , 0.0442 ml/kg and 0.0625 mL/kg in 10% (v/v) in 0.25% methyl cellulose: LD50 = 57 mg/kg (males), LD50 = 51 mg/kg (females), Toxicity Cat. IIIAcute Toxicity oral: acute oral gavage study, wild-trapped birds: LD50 values are for Agelaius phoeniceus (redwinged blackbird): 178 mg/kg bw; Sturnus vulgaris (European starling): 1000 mg/kg bw; Coturnix coturnix (Coturnix): 422 mg/kg bw; Passer domesticus (House sparrow): >1000 mg/kg bwAcute Toxicity oral: acute oral study, rat: LD50 = 46 µl/kg Quality of whole database: There are three studies available on acute oral toxicity, one Klimisch 2 on rats, and two Klimisch 4 on either wild birds and rats. The Klimisch 2 studies reveals very similar LD50 values for male and female rats, and the Klimisch 4 supporting study on rats reveals consistently a similar value. Hence, the result can be considered as sufficiently reliable as they are consistent and plausible, the tonnage-driven data requirements under REACH are fully met, and the database is of good quality. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/490b9301-15b8-47d5-9321-740dbad2355f/documents/IUC5-aeb14761-d076-4e8e-8018-694c7510d2e3_ff451f58-79ec-40c6-84c6-f575106576cb.html,,,,,, Methyl 3-pyridyl ketone,350-03-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/490b9301-15b8-47d5-9321-740dbad2355f/documents/IUC5-aeb14761-d076-4e8e-8018-694c7510d2e3_ff451f58-79ec-40c6-84c6-f575106576cb.html,,oral,LD50,51 mg/kg bw,adverse effect observed, "Methyl 3-α,7-α-diacetoxy-12-oxo-5-β-cholan-24-oate",28535-81-1,The repeated oral toxicity of the simila substance ursodeoxycholic acid has been evaluated in a 26-week study (1987). No Guideline or followed method is available in the source RTECS. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a3d8aae-302d-4c43-86fe-b60e9fdefbeb/documents/IUC5-81958ce7-7422-44ff-950c-e0cf587edad0_30145e26-22f2-42c9-97e6-d562568b20af.html,,,,,, "Methyl 3-α,7-α-diacetoxy-12-oxo-5-β-cholan-24-oate",28535-81-1,The predicted oral LD50 in rats is 1600 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a3d8aae-302d-4c43-86fe-b60e9fdefbeb/documents/IUC5-03ab7252-666d-41e4-b6aa-6d19f9a457dd_30145e26-22f2-42c9-97e6-d562568b20af.html,,,,,, "Methyl 3-α,7-α-diacetoxy-12-oxo-5-β-cholan-24-oate",28535-81-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a3d8aae-302d-4c43-86fe-b60e9fdefbeb/documents/IUC5-03ab7252-666d-41e4-b6aa-6d19f9a457dd_30145e26-22f2-42c9-97e6-d562568b20af.html,,oral,LD50,"1,600 mg/kg bw",adverse effect observed, "Methyl 3-α,7-α-diacetoxy-12-α-hydroxy-5-β-cholan-24-oate",3749-87-9,No reliable data are available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ff61fa5-c0a7-4923-8c15-cafabaaf368a/documents/IUC5-59da08db-81e5-4327-9f62-980f581fb200_ef804068-6a9f-42de-b842-a72465d39a50.html,,,,,, Methyl 4-(acetylamino)-5-bromo-o-anisate,4093-34-9, Acute oral toxicity: Key study: OECD 423 and EU method B.1 tris. Klimish score = 1. GLP study. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a389eb14-a328-4108-980e-b967ca874400/documents/4e3fa247-81d0-4107-9498-8f36cf71dcd7_29ab0556-30cd-4ae3-bc17-2e0c53d9d3ac.html,,,,,, Methyl 4-(acetylamino)-5-bromo-o-anisate,4093-34-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a389eb14-a328-4108-980e-b967ca874400/documents/4e3fa247-81d0-4107-9498-8f36cf71dcd7_29ab0556-30cd-4ae3-bc17-2e0c53d9d3ac.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-[[2-hydroxy-3-[[(2-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]benzoate",61847-48-1,"PR 112 subacute, oral: The toxicity of the test item when given by oral administration (gavage) to groups of 5 rats per sex per dose for 28 consecutive days at dosages of 0, 100, 300 or 1000 mg/kg bw/day, for 7 days/week have been investigated. No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). Red staining of various body parts, red faeces and reddish contents of the gastro-intestinal tract noted among all groups treated with the test substance was considered to be related to staining properties of the test substance, and not to represent signs of systemic toxicity. No correlating histopathological abnormalities were noted. On the basis of these results, the high dose level of 1000 mg/kg/day was considered to be the No Observed Adverse Effect Level (NOAEL) for the test substance.   PR022 A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test was performed according to OECD TG 422. The test item was administered to Sprague Dawley rats (12/sex/dose) by gavage at dose levels of 0, 100, 300 and 1000 mg/kg/day for a total of 37 days (males) and through mating, gestation and delivery until day 4 of lactation (females). No toxic effects were observed in this study except increased liver weights in males and females of the highest dose group. As the effects on liver weight were minimal (less than 10% weight changes) and not accompanied by any histopathological or biochemical changes these effects were judged not to be adverse. The no-observed-adverse-effect level (NOAEL) for repeated dose toxicity was 1000 mg/kg under the conditions of this study. There were no effects on reproduction or development.   PR 112 subchronic, inhalation: The objective of the OECD TG 413 following study was to determine the toxic potential of the test item, Pigment Red 112, when administered for 6 hours/day, 5 days per week, for 13 consecutive weeks by flow-past nose-only inhalation route to Sprague Dawley rats. This study provides information on toxic effects, target organs, the possibility of cumulative effects, the reversibility of effects (after 90 and 180 days recovery period), and an estimate of the No Observed Adverse Effects Concentration (NOAEC). Based on the observed results, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item was found to be 30 mg/m³ (0,03 mg/L) after 90 days of exposure (highest concentration tested). The nominal dose of 0.03 mg/L (6 hrs/day, 5 days/week) corresponded to an actual exposure concentration in males and females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/012d5349-aa71-49a4-a19f-c1982fb8d56d/documents/5bad8441-da6d-4cb0-ba3f-369e4abfb7fc_cb98f236-87ba-46ad-9173-027542d16d23.html,,,,,, "Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-[[2-hydroxy-3-[[(2-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]benzoate",61847-48-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/012d5349-aa71-49a4-a19f-c1982fb8d56d/documents/5bad8441-da6d-4cb0-ba3f-369e4abfb7fc_cb98f236-87ba-46ad-9173-027542d16d23.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-[[2-hydroxy-3-[[(2-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]benzoate",61847-48-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/012d5349-aa71-49a4-a19f-c1982fb8d56d/documents/5bad8441-da6d-4cb0-ba3f-369e4abfb7fc_cb98f236-87ba-46ad-9173-027542d16d23.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat "Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-[[2-hydroxy-3-[[(2-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]benzoate",61847-48-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/012d5349-aa71-49a4-a19f-c1982fb8d56d/documents/5bad8441-da6d-4cb0-ba3f-369e4abfb7fc_cb98f236-87ba-46ad-9173-027542d16d23.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat "Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-[[2-hydroxy-3-[[(2-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]benzoate",61847-48-1,"Oral toxicity   The test item and analogous substance, Pigment Red 112, did not cause any mortality or significant clinical signs or necropsy findings after single oral gavage administration to male and female rats at 5000 mg/kg bw in a OECD guideline and GLP compliant study. The LD50 (male/female rat) was greater than 5000 mg/kg body weight.   Inhalation toxicity The test item did not cause any mortality or significant clinical signs or necropsy findings after single acute inhalation (4 hours) of 5.05 mg/L pigment dust in Wistar rats. Therefore, the Median Lethal Concentration (LC50) value of the test item is more than 5.05 mg/L of chamber air.   Dermal toxicity The Test item and analogous substance, Pigment Red 112, did not cause any mortality or significant clinical signs or necropsy findings after single dermal application to male rats at 5000 mg/kg bw in a OECD guideline compliant study. The LD50 (male rat) was greater than 5000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/012d5349-aa71-49a4-a19f-c1982fb8d56d/documents/10337da0-4ff6-4804-a56d-2c4dd6163d3b_cb98f236-87ba-46ad-9173-027542d16d23.html,,,,,, "Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-[[2-hydroxy-3-[[(2-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]benzoate",61847-48-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/012d5349-aa71-49a4-a19f-c1982fb8d56d/documents/10337da0-4ff6-4804-a56d-2c4dd6163d3b_cb98f236-87ba-46ad-9173-027542d16d23.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-[[2-hydroxy-3-[[(2-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]benzoate",61847-48-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/012d5349-aa71-49a4-a19f-c1982fb8d56d/documents/10337da0-4ff6-4804-a56d-2c4dd6163d3b_cb98f236-87ba-46ad-9173-027542d16d23.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-[[2-hydroxy-3-[[(2-methoxyphenyl)amino]carbonyl]-1-naphthyl]azo]benzoate",61847-48-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/012d5349-aa71-49a4-a19f-c1982fb8d56d/documents/10337da0-4ff6-4804-a56d-2c4dd6163d3b_cb98f236-87ba-46ad-9173-027542d16d23.html,,inhalation,LC50,> 5.05 mg/L,no adverse effect observed, "Methyl 4-[[(2,5-dichlorophenyl)amino]carbonyl]-2-nitrobenzoate",83929-47-9,Single oral application of 1524 mg/kg bw did not cause toxicity or lethality in rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0db1b1fa-19d5-4111-959d-670c914479be/documents/IUC5-c137b6d3-e950-4eca-b005-7258c341d1c4_45b4ee73-60b4-47c4-8dcd-8e5baa56362d.html,,,,,, Methyl 4-[2-[4-(5-methyl-2-benzoxazolyl)phenyl]vinyl]benzoate,18039-18-4, LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af25d729-64ae-4189-be76-2cf067dde5dd/documents/97d16a64-83f1-4ce8-a1ef-943244e85f2f_9c82bffe-d721-405f-9f02-93b88f520182.html,,,,,, Methyl 4-[2-[4-(5-methyl-2-benzoxazolyl)phenyl]vinyl]benzoate,18039-18-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af25d729-64ae-4189-be76-2cf067dde5dd/documents/97d16a64-83f1-4ce8-a1ef-943244e85f2f_9c82bffe-d721-405f-9f02-93b88f520182.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl 4-[2-fluoro-3-[3-(6-methylpyridin-3yl)ureido]benzyl]piperazine-1-carboxylate,873697-71-3, Omecamtiv mecarbil was tested in a 13 week oral gavage study in rats and dogs and in a 26 week and 39 week oral study in rats and dog ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/518074ff-3a02-4c25-96ae-eb3b99394a61/documents/9dba6a4f-d601-4bbf-a142-6ddfb606d667_a76786bc-90ce-4797-8f49-5303df986601.html,,,,,, Methyl 4-[2-fluoro-3-[3-(6-methylpyridin-3yl)ureido]benzyl]piperazine-1-carboxylate,873697-71-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/518074ff-3a02-4c25-96ae-eb3b99394a61/documents/9dba6a4f-d601-4bbf-a142-6ddfb606d667_a76786bc-90ce-4797-8f49-5303df986601.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,1.5 mg/kg bw/day,,dog "Methyl 4-cyano-5-[[5-cyano-2,6-bis[(3-methoxypropyl)amino]-4-methyl-3-pyridyl]azo]-3-methyl-2-thenoate",72968-71-9,"Short-term Repeated Dose Toxicity: OECD TG 407, GLP, 28 Day, rat, oral, Result: NOAEL: 1000 mg/kg bw/day.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32ce2f5d-70d1-435b-a9f7-bc91873e61e9/documents/94ce9b82-a391-4d60-9a60-041c3a11a02d_b06d338e-4553-4ce8-a306-ffc7e5cb702d.html,,,,,, "Methyl 4-cyano-5-[[5-cyano-2,6-bis[(3-methoxypropyl)amino]-4-methyl-3-pyridyl]azo]-3-methyl-2-thenoate",72968-71-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32ce2f5d-70d1-435b-a9f7-bc91873e61e9/documents/94ce9b82-a391-4d60-9a60-041c3a11a02d_b06d338e-4553-4ce8-a306-ffc7e5cb702d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Methyl 4-cyano-5-[[5-cyano-2,6-bis[(3-methoxypropyl)amino]-4-methyl-3-pyridyl]azo]-3-methyl-2-thenoate",72968-71-9,"Acute oral toxicity: No guideline, 5 rats/sex/dose, single dose of 10000 mg Thermoplastrot Lm 74/400 (35% suspension in Carboxymethyl cellulose)/kg bw by gavage. 14 day observation (mortality, clinical signs and body weight),  histopathological examination at the end of the study. Results: No mortalities occurred, Discriminating dose = 10000 mg/kg bw.   Acute inhalation toxicity: No guideline, twelve rats (male and female) were exposed to a dust atmosphere of Thermoplastrot Lm 74/400 for 8 hours at a concentration of 2.35 mg/L. After one week the animals were killed and dissected. No deaths occurred. Discriminating dose = 2.35 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32ce2f5d-70d1-435b-a9f7-bc91873e61e9/documents/5a693356-a1f4-4b5d-bfd8-7820ebe5ef5b_b06d338e-4553-4ce8-a306-ffc7e5cb702d.html,,,,,, "Methyl 4-cyano-5-[[5-cyano-2,6-bis[(3-methoxypropyl)amino]-4-methyl-3-pyridyl]azo]-3-methyl-2-thenoate",72968-71-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32ce2f5d-70d1-435b-a9f7-bc91873e61e9/documents/5a693356-a1f4-4b5d-bfd8-7820ebe5ef5b_b06d338e-4553-4ce8-a306-ffc7e5cb702d.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "Methyl 4-cyano-5-[[5-cyano-2,6-bis[(3-methoxypropyl)amino]-4-methyl-3-pyridyl]azo]-3-methyl-2-thenoate",72968-71-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32ce2f5d-70d1-435b-a9f7-bc91873e61e9/documents/5a693356-a1f4-4b5d-bfd8-7820ebe5ef5b_b06d338e-4553-4ce8-a306-ffc7e5cb702d.html,,inhalation,discriminating conc.,"2,350 mg/m3",no adverse effect observed, "Methyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide",35511-15-0," Acute toxicity by oral route Acute oral toxicity data are not available for methyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide. For the similar substance Ethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide the following data are available: •       guinea pig, oral LD50 =       5300 mg/kg •       rat, oral LD50 = 4800 mg/kg. Overall, available data are conclusive but not sufficient for the classification of the substance. Acute toxicity by inhalation route Acute inhalation toxicity data are not available for methyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide. For the similar substance Ethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide the following data is available: •       rat, inhalation       LC50 = 1562 mg/m3. Detailed information on the type of exposure are not available; moreover, detailed information on the duration of exposure is not available.   Overall, available data are inconclusive for the classification of the substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6664fb2a-48d4-42d6-8dc6-3ca940a1eae9/documents/7f2b41b5-59fd-46e4-b054-dc03a9769202_637063b7-1d31-4733-a4cd-fb29294cb918.html,,,,,, Methyl 4-hydroxyphenylacetate,14199-15-6," For Methyl (4-hydroxyphenyl)acetate,ACD/Percepta provided anLD50prediction equal to 2100 mg/kg, and the prediction is assessed as moderate reliable being the reliability index equal to 0.64. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55a45ab0-92f0-4c2c-9a3a-12852d0e4daf/documents/8a8c4a12-2380-4467-a72c-7fde6907fffb_7e28c464-5cf9-476a-9d94-3b33ea87fee5.html,,,,,, Methyl 4-hydroxyphenylacetate,14199-15-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55a45ab0-92f0-4c2c-9a3a-12852d0e4daf/documents/8a8c4a12-2380-4467-a72c-7fde6907fffb_7e28c464-5cf9-476a-9d94-3b33ea87fee5.html,,oral,LD50,"2,100 mg/kg bw",, "methyl 4-iodo-2-(3-(4-methoxy-6-methyl-1,3,5-triazine-2-yl)ureidosulfonyl)benzoate",144550-06-1,"Dog, 1-year RA-A: Key, M-181091-01-1, 1 year, dog, GLP, similar to OECD 409 NOAEL = 200 ppm (corresponding to 7.37, 7.25 or 7.31 mg/kg bw/day for males, females or combined sexes, respectively) LOAEL = 1200 ppm (corresponding to 41.8, 43.7 or 42.8 mg/kg bw/day for males, females or combined sexes, respectively)   Rat, 2-years RA-A: Key, M-181889-01-1, 2 years, rat, GLP, according to OECD 453 NOAEL (general systemic toxicity) = 70 ppm (corresponding to 2.96 mg/kg bw/day in males and 3.91 mg/kg bw/day in females, and to 3.44 mg/kg bw/day for combined sexes) LOAEL (general systemic toxicity) = 700 ppm (corresponding to 29.7 in males and 39.1 mg/kg bw/day in females, and to 34.4 mg/kg bw/day for combined sexes) NOAEL (carcinogenicity) ≥ 7000 (corresponding to 331 mg/kg bw/day in males and 452 mg/kg bw/day in females, and to 392 mg/kg bw/day for combined sexes) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c125ed0-083d-4aec-99d0-cf1e74b63772/documents/584ab70c-d233-4d44-b68a-230c38ca7455_82adbf3b-4963-463b-8858-1e0c81de76a0.html,,,,,, "methyl 4-iodo-2-(3-(4-methoxy-6-methyl-1,3,5-triazine-2-yl)ureidosulfonyl)benzoate",144550-06-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c125ed0-083d-4aec-99d0-cf1e74b63772/documents/584ab70c-d233-4d44-b68a-230c38ca7455_82adbf3b-4963-463b-8858-1e0c81de76a0.html,Chronic toxicity – systemic effects,oral,NOAEL,2.96 mg/kg bw/day,,rat "methyl 4-iodo-2-(3-(4-methoxy-6-methyl-1,3,5-triazine-2-yl)ureidosulfonyl)benzoate",144550-06-1,"RA-A: Oral (according to OECD 401), rat: LD50 > 2000 mg/kg bw (males and females) RA-A: Inhalation (according to OECD 403), rat: LC50 > 2.81 mg/L (males and females) (maximum technically attainable concentration) Dermal (according to OECD 402), rat: LD50 > 2000 mg/kg bw (males and females) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c125ed0-083d-4aec-99d0-cf1e74b63772/documents/8a36c80b-0cb9-46db-b492-83bc952c1bae_82adbf3b-4963-463b-8858-1e0c81de76a0.html,,,,,, "methyl 4-iodo-2-(3-(4-methoxy-6-methyl-1,3,5-triazine-2-yl)ureidosulfonyl)benzoate",144550-06-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c125ed0-083d-4aec-99d0-cf1e74b63772/documents/8a36c80b-0cb9-46db-b492-83bc952c1bae_82adbf3b-4963-463b-8858-1e0c81de76a0.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "methyl 4-iodo-2-(3-(4-methoxy-6-methyl-1,3,5-triazine-2-yl)ureidosulfonyl)benzoate",144550-06-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c125ed0-083d-4aec-99d0-cf1e74b63772/documents/8a36c80b-0cb9-46db-b492-83bc952c1bae_82adbf3b-4963-463b-8858-1e0c81de76a0.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "methyl 4-iodo-2-(3-(4-methoxy-6-methyl-1,3,5-triazine-2-yl)ureidosulfonyl)benzoate",144550-06-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c125ed0-083d-4aec-99d0-cf1e74b63772/documents/8a36c80b-0cb9-46db-b492-83bc952c1bae_82adbf3b-4963-463b-8858-1e0c81de76a0.html,,inhalation,LC50,> 2.81 mg/L,no adverse effect observed, Methyl 4-methyl-3-oxopentanoate,42558-54-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/baa73815-ccc8-4245-9307-299b53fb3734/documents/f403d537-4e0e-4095-8752-add515c7d8bb_113e257d-415b-4289-b446-9fbc682b4d34.html,,oral,LD50,"6,600 mg/kg bw",adverse effect observed, Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate,1174627-68-9,"Based on a slight increase in kidney weight observed only at the highest tested dose in a rat OECD 408 study, the ‘No Observed Adverse Effect Level’ (NOAEL) of Rhodiasolv Polarclean given by the oral route was considered to be 1000 mg/kg/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP compliant study performed according to the OECD 408 Guideline (Klimisch score = 1) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/355870b0-d40e-43e9-88ef-89bc13a95c11/documents/1ef7f406-2bc6-437c-982e-4d6a232b3a8c_c40f4060-558f-4207-838c-7c90aef50751.html,,,,,, Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate,1174627-68-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/355870b0-d40e-43e9-88ef-89bc13a95c11/documents/1ef7f406-2bc6-437c-982e-4d6a232b3a8c_c40f4060-558f-4207-838c-7c90aef50751.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate,1174627-68-9,"For the endpoints of the chapter 7.2, the name of the tested substance is either DV-SOLV 1059 or Rhodiasolv Polarclean.DV-SOLV 1059 is the previous name of the Rhodiasolv Polarclean. The specifications of the DV-SOLV 1059 are in line with the dossier and representative of the industrial product.An acute oral and an acute dermal toxicity studies were performed in rat. The LD50 were > 2000 mg/kg bw in both studies . Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP-compliant study performed according to the OECD 423 Guideline (Klimisch score = 1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): GLP-compliant study performed according to the OECD 402 Guideline (Klimisch score = 1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/355870b0-d40e-43e9-88ef-89bc13a95c11/documents/c07288d0-9818-428b-af78-1ae09041f0ef_c40f4060-558f-4207-838c-7c90aef50751.html,,,,,, Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate,1174627-68-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/355870b0-d40e-43e9-88ef-89bc13a95c11/documents/c07288d0-9818-428b-af78-1ae09041f0ef_c40f4060-558f-4207-838c-7c90aef50751.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Methyl 5-(dimethylamino)-2-methyl-5-oxopentanoate,1174627-68-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/355870b0-d40e-43e9-88ef-89bc13a95c11/documents/c07288d0-9818-428b-af78-1ae09041f0ef_c40f4060-558f-4207-838c-7c90aef50751.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Methyl 5-nitrohydrogen.isophthalate,1955-46-0," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.000272 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a6c6717-4c11-4b14-9e8b-3c9d9be3b9b8/documents/d0488a5a-5e07-40fc-8e5b-fc2f0aba05b4_2b926072-85bd-43be-8d7f-70d90b53e536.html,,,,,, Methyl 5-nitrohydrogen.isophthalate,1955-46-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a6c6717-4c11-4b14-9e8b-3c9d9be3b9b8/documents/d0488a5a-5e07-40fc-8e5b-fc2f0aba05b4_2b926072-85bd-43be-8d7f-70d90b53e536.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl 5-nitrohydrogen.isophthalate,1955-46-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a6c6717-4c11-4b14-9e8b-3c9d9be3b9b8/documents/d0488a5a-5e07-40fc-8e5b-fc2f0aba05b4_2b926072-85bd-43be-8d7f-70d90b53e536.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, methyl acrylate; methyl propenoate,96-33-3,"In a subchronic study in Sprague-Dawley rats following vapour inhalation for 12-weeks, the NOAEC was 82 mg/m3. The respective LOAEC based on reduced body weight and reduced organ weights was 440 mg/m3. Following chronic exposure by the inhalation route (5 d/w, 6 h/d), the LOAEC for local effects (nasal and ocular) in rats was 58 mg/m3. The systemic NOAEC was >= 519 mg/m3. Following a 90-day oral administration of MA in the drinking water, the NOAEL was 5 mg/kg bw/d for CDF Fischer 344 rats. The LOAEL was 20 mg/kg bw/day based on changes in kidney weights. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b434cec-bb8b-499c-b6af-437bcc18184e/documents/IUC5-26fee43d-aa57-44aa-8699-1b3a4bf4b83a_3e467f19-7a59-4e6a-8560-6207972b6aea.html,,,,,, methyl acrylate; methyl propenoate,96-33-3,"Methyl acrylate is of moderate toxicity after single ingestion and after short-term skin contact. Methyl acrylate is of pronounced toxicity after short-term inhalation.Oral: LD50 = ca. 768 mg/kg bw (rat, BASF Test)Dermal: LD50: ca. 1250 mg/kg bw (rabbit, occlusive)Inhalation: LC50 = <10.832 mg/L (rat, comparable to OECD TG 403) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b434cec-bb8b-499c-b6af-437bcc18184e/documents/IUC5-e7ccf097-8d12-4b5e-a055-990ed9b45c5d_3e467f19-7a59-4e6a-8560-6207972b6aea.html,,,,,, methyl acrylate; methyl propenoate,96-33-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b434cec-bb8b-499c-b6af-437bcc18184e/documents/IUC5-e7ccf097-8d12-4b5e-a055-990ed9b45c5d_3e467f19-7a59-4e6a-8560-6207972b6aea.html,,oral,LD50,768 mg/kg bw,, methyl acrylate; methyl propenoate,96-33-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b434cec-bb8b-499c-b6af-437bcc18184e/documents/IUC5-e7ccf097-8d12-4b5e-a055-990ed9b45c5d_3e467f19-7a59-4e6a-8560-6207972b6aea.html,,dermal,LD50,"1,250 mg/kg bw",, methyl acrylate; methyl propenoate,96-33-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b434cec-bb8b-499c-b6af-437bcc18184e/documents/IUC5-e7ccf097-8d12-4b5e-a055-990ed9b45c5d_3e467f19-7a59-4e6a-8560-6207972b6aea.html,,inhalation,LC50,"10,832 mg/m3",, Methyl chloroacetate,96-34-4,Experimental results on a 28-day inhalation study conducted according to OECD guideline 412. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37fb00c6-24f8-4012-bbda-49307610e12b/documents/IUC5-e8f01511-b5ec-4e87-bb38-8c5dd69af96d_817a4cf9-2295-471f-8be2-773b47b9c7a3.html,,,,,, Methyl chloroacetate,96-34-4,Key studies: Experimental studies conducted with the substance methyl chloroacetate: LD50 oral (rat) = 107 mg/kg bw (no guideline was followed but the test method was similar to OECD 401). LD50 dermal (rat) = 137 mg/kg bw (no guideline was followed but the test method was similar to OECD 402). LD50 inhalation (rat) = 638 mg/m3 (OECD 403). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37fb00c6-24f8-4012-bbda-49307610e12b/documents/IUC5-d621c74a-dee8-49d2-b24b-e2bcbf46524c_817a4cf9-2295-471f-8be2-773b47b9c7a3.html,,,,,, Methyl chloroacetate,96-34-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37fb00c6-24f8-4012-bbda-49307610e12b/documents/IUC5-d621c74a-dee8-49d2-b24b-e2bcbf46524c_817a4cf9-2295-471f-8be2-773b47b9c7a3.html,,oral,LD50,107 mg/kg bw,, Methyl chloroacetate,96-34-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37fb00c6-24f8-4012-bbda-49307610e12b/documents/IUC5-d621c74a-dee8-49d2-b24b-e2bcbf46524c_817a4cf9-2295-471f-8be2-773b47b9c7a3.html,,dermal,LD50,137 mg/kg bw,, Methyl chloroacetate,96-34-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37fb00c6-24f8-4012-bbda-49307610e12b/documents/IUC5-d621c74a-dee8-49d2-b24b-e2bcbf46524c_817a4cf9-2295-471f-8be2-773b47b9c7a3.html,,inhalation,LC50,638 mg/m3,, Methyl chloroformate,79-22-1,- local 90-day NOAEC = 1.6 mg/m3/day- systemic 90-day NOAEC = 7.8 mg/m3/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcbeaef1-4fcc-4e6d-8601-2bc77b047150/documents/IUC5-1c86222c-f080-473d-aea7-95c14b2d310e_5159ed00-5c4c-4c46-a18c-d451ac554a99.html,,,,,, Methyl chloroformate,79-22-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcbeaef1-4fcc-4e6d-8601-2bc77b047150/documents/IUC5-1c86222c-f080-473d-aea7-95c14b2d310e_5159ed00-5c4c-4c46-a18c-d451ac554a99.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,1.6 mg/m3,,rat Methyl chloroformate,79-22-1,"Methyl chloroformate is very toxic after inhalation, being the relevant route of exposure. The substance is toxic to harmful after oral administration depending on the vehicle. Dermal toxicity of methyl chloroformate is low . ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcbeaef1-4fcc-4e6d-8601-2bc77b047150/documents/IUC5-67e19f9b-4065-4ac9-9e2c-33fe1fdb6de8_5159ed00-5c4c-4c46-a18c-d451ac554a99.html,,,,,, Methyl chloroformate,79-22-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcbeaef1-4fcc-4e6d-8601-2bc77b047150/documents/IUC5-67e19f9b-4065-4ac9-9e2c-33fe1fdb6de8_5159ed00-5c4c-4c46-a18c-d451ac554a99.html,,oral,LD50,40 mg/kg bw,adverse effect observed, Methyl chloroformate,79-22-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcbeaef1-4fcc-4e6d-8601-2bc77b047150/documents/IUC5-67e19f9b-4065-4ac9-9e2c-33fe1fdb6de8_5159ed00-5c4c-4c46-a18c-d451ac554a99.html,,inhalation,LC50,60 mg/m3,adverse effect observed, Methyl cholate,1448-36-8,No reliable data are available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72e14988-e48d-49c1-bbf4-7d6b7a9a0756/documents/IUC5-0c057ed3-2684-4fff-9c6e-3927f20c3d85_d44b34ad-517f-4ac5-924b-59da5db6c9b0.html,,,,,, Methyl cyanoacetate,105-34-0,"No studies on the acute toxicity of methyl cyanoacetate are available. Nevertheless, according to a MSDS by Sigma-Aldrich (2008), the LD50 for acute oral toxicity of methyl cyanoacetate in rat is 3062 mg/kg bw. . For the dermal route, an LD50 > 2000 mg/kg bw for rabbit is reported by Sigma-Aldrich in the MSDS mentioned above.No data on acute inhalation are available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2bd9e5c-d0c8-490e-8665-b2b45f7206ac/documents/IUC5-8d431636-e01e-4c95-92d1-8ce75f8a14ab_92141469-7a5b-4f82-a69c-cf9afb4c3bc8.html,,,,,, Methyl dodec-9-enoate,39202-17-0,"• Repeat dose oral (OECD 422 and OECD 408, read-across): No toxicologically significant effects were observed during the course of these studies at doses up to 1000 mg/kg/day. The NOAEL for systemic toxicity was considered to be 1000 mg/kg bw/day.• Repeat dose dermal: No studies are available• Repeat dose inhalation: No studies are available ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5ec5748-4e57-4059-8e62-cf0ee97c4a2c/documents/IUC5-fb6842a1-5381-462e-a138-b607a8e924fa_189b096b-314f-40e4-b5f0-2d3cc0b57138.html,,,,,, Methyl dodec-9-enoate,39202-17-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5ec5748-4e57-4059-8e62-cf0ee97c4a2c/documents/IUC5-fb6842a1-5381-462e-a138-b607a8e924fa_189b096b-314f-40e4-b5f0-2d3cc0b57138.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Methyl dodec-9-enoate,39202-17-0,"• Oral LD50 > 2000 mg/kg bodyweight (OECD 420)• Dermal LD50 > 2000 mg/kg bodyweight (OECD 402, read-across) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5ec5748-4e57-4059-8e62-cf0ee97c4a2c/documents/IUC5-9487a5ac-1161-49c4-b5fa-1d5ef4101d65_189b096b-314f-40e4-b5f0-2d3cc0b57138.html,,,,,, "Methyl hydrogen (endo-endo)-bicyclo[2.2.1]hept-5-ene-2,3-dicarboxylate",4883-79-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Method OECD 420 - experimental study LD50 > 2000 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdd10f83-8328-4adb-9f00-c3bd0b412b8e/documents/aa578684-7d35-4380-9a78-0f601c6a26e9_3fff6231-526b-491f-aa5a-70784727d47b.html,,,,,, "Methyl hydrogen (endo-endo)-bicyclo[2.2.1]hept-5-ene-2,3-dicarboxylate",4883-79-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdd10f83-8328-4adb-9f00-c3bd0b412b8e/documents/aa578684-7d35-4380-9a78-0f601c6a26e9_3fff6231-526b-491f-aa5a-70784727d47b.html,,dermal,LD50,"72,000 mg/kg bw",no adverse effect observed, Methyl isonicotinate,2459-09-8," Acute oral toxicity:  Based on the prediction done by SSS (2017) on Methyl isonicotinate, LD50 was estimated to be 3906 mg/kg bw, when Sprague-Dawley male and female rats were treated with Methyl isonicotinate by oral gavage route. Thus, comparing this value with the criteria of CLP regulation, Methyl isonicotinate can be classified as category V for acute oral toxicity. Acute Dermal toxicity:  Based on the prediction done by SSS (2017) on Methyl isonicotinate, LD50 was estimated to be 3828 mg/kg bw, when rabbits were treated with Methyl isonicotinate by dermal application occlusively. Thus, comparing this value with the criteria of CLP regulation, Methyl isonicotinate can be classified as category V for acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bd80ab8-f04a-495e-9f6a-2460b298553e/documents/c75800c8-6d6b-485a-bab0-f44d5a9c0377_523992ab-a0b3-450d-a8a7-674df99ff3f5.html,,,,,, Methyl isonicotinate,2459-09-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bd80ab8-f04a-495e-9f6a-2460b298553e/documents/c75800c8-6d6b-485a-bab0-f44d5a9c0377_523992ab-a0b3-450d-a8a7-674df99ff3f5.html,,oral,LD50,"3,906 mg/kg bw",no adverse effect observed, Methyl isonicotinate,2459-09-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bd80ab8-f04a-495e-9f6a-2460b298553e/documents/c75800c8-6d6b-485a-bab0-f44d5a9c0377_523992ab-a0b3-450d-a8a7-674df99ff3f5.html,,dermal,LD50,"3,828 mg/kg bw",no adverse effect observed, Methyl isothiocyanate,556-61-6,"In a combined oral repeated dose and reproduction / developmental screening test (OECD 422) in rats, the NOAEL for methyl isothiocynate was 8 mg/kg bw/d for sytemic toxicity.In a 4-week inhalation rat study (OECD 412), at doses of 100 mg methyl isothiocyanate/m3, lung weight was increased, and was associated with bronchopneumonia and epithelial proliferation in bronchi and bronchiole. At this dose level, proliferation in tracheal epithelial cells and inflammatory changes in the nasal cavity and atrophy of the olfactory epithelium as well as focal metaplasia of squamous epithelial cells in the area of respiratory epithelium were reported. The NOAEC for respiratory tract irritation and for systemic effects was 19.9 mg/m3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3005e32-59ad-48d1-bd42-8a79c0fb2c0a/documents/IUC5-2b636b7c-ed33-4738-a478-c795b932074e_76fe815f-0ed3-4b3a-adef-2e0fcfdf390c.html,,,,,, Methyl isothiocyanate,556-61-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3005e32-59ad-48d1-bd42-8a79c0fb2c0a/documents/IUC5-2b636b7c-ed33-4738-a478-c795b932074e_76fe815f-0ed3-4b3a-adef-2e0fcfdf390c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,8 mg/kg bw/day,,rat Methyl isothiocyanate,556-61-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3005e32-59ad-48d1-bd42-8a79c0fb2c0a/documents/IUC5-2b636b7c-ed33-4738-a478-c795b932074e_76fe815f-0ed3-4b3a-adef-2e0fcfdf390c.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,19.9 mg/m3,,rat Methyl isothiocyanate,556-61-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3005e32-59ad-48d1-bd42-8a79c0fb2c0a/documents/IUC5-2b636b7c-ed33-4738-a478-c795b932074e_76fe815f-0ed3-4b3a-adef-2e0fcfdf390c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,19.9 mg/m3,adverse effect observed,rat Methyl isothiocyanate,556-61-6,"Methyl isothiocyanate is acutely toxic by the oral, dermal and inhalation routes. In guideline studies, the oral LD50 in rats was 77 or between 50 and 300 mg/kg bw, the 1-hour LC50 in rats was 1.9 mg/l (4-h LC50 estimated at 0.85 mg/l) and the dermal LD50 was 174 mg/kg bw in rabbits and 198 mg/kg bw in rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3005e32-59ad-48d1-bd42-8a79c0fb2c0a/documents/IUC5-4f496ae7-6d7f-4090-8f45-b9f1b4508ffa_76fe815f-0ed3-4b3a-adef-2e0fcfdf390c.html,,,,,, Methyl isothiocyanate,556-61-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3005e32-59ad-48d1-bd42-8a79c0fb2c0a/documents/IUC5-4f496ae7-6d7f-4090-8f45-b9f1b4508ffa_76fe815f-0ed3-4b3a-adef-2e0fcfdf390c.html,,oral,LD50,67 mg/kg bw,adverse effect observed, Methyl isothiocyanate,556-61-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3005e32-59ad-48d1-bd42-8a79c0fb2c0a/documents/IUC5-4f496ae7-6d7f-4090-8f45-b9f1b4508ffa_76fe815f-0ed3-4b3a-adef-2e0fcfdf390c.html,,dermal,LD50,174 mg/kg bw,adverse effect observed, Methyl isothiocyanate,556-61-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3005e32-59ad-48d1-bd42-8a79c0fb2c0a/documents/IUC5-4f496ae7-6d7f-4090-8f45-b9f1b4508ffa_76fe815f-0ed3-4b3a-adef-2e0fcfdf390c.html,,inhalation,LC50,"1,900 mg/m3",adverse effect observed, Methyl methanesulphonate,66-27-3," Repeated Dose Toxicity: Oral In Repeated dose subacute oral toxicity study, Male Sprague – Dawley rats were treated with Methyl Methansulfonate (MMS) at a concentration of 0, 20 or 40 mg/kg body weight/day orally by gavage for 2 weeks. The animals were observed for clinical signs, mortality, body weight changes, food consumption, gross pathology and histopathology. No effects were observed on mortality, clinical sign, body weight and food consumption at 20 mg/kg body weight/day treated rat as compared to control. Observation made suggest the No observed adverse effect level (NOAEL) was considered to be 20 mg/kg body weight /day when Sprague – Dawley male rats were exposed to Methyl Methansulfonate (MMS) for 2 weeks. Repeated dose toxicity: Inhalation Repeated dose inhalation toxicity study was performed by Sellkumar et al (Jounal of National Cancer Institute, 1987) to determine the toxic nature of Methylmethane sulfonate (MMS) in rat upon repeated exposure. 11 -12 week old Male Sprague Dawley rat were exposed to MMS at a dose level of 0 or 5 mg/L for 30 days. All animals were observed daily, weighed monthly, and allowed to die spontaneously or sacrificed when moribund. A complete necropsy was performed on each animal. On the basis of observations made, the low-observed-adverse-effect concentration (LOAEC)  was considered to be 5 mg/L (50ppm) when Sprague-Dawley male rat were exposed to Methylmethane sulfonate (MMS) upon repeated exposure for 30 days. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b26ee86-520b-4301-9ed0-07667f812b88/documents/bd115cd6-e6ed-4572-bbcb-a30fb09491ef_a7d1f61c-a431-44b4-b7f9-65012b40934c.html,,,,,, Methyl methanesulphonate,66-27-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b26ee86-520b-4301-9ed0-07667f812b88/documents/bd115cd6-e6ed-4572-bbcb-a30fb09491ef_a7d1f61c-a431-44b4-b7f9-65012b40934c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat Methyl methanesulphonate,66-27-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b26ee86-520b-4301-9ed0-07667f812b88/documents/bd115cd6-e6ed-4572-bbcb-a30fb09491ef_a7d1f61c-a431-44b4-b7f9-65012b40934c.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,"5,000 mg/m3",,rat Methyl methanesulphonate,66-27-3," Acute oral toxicity:  Acute oral toxicity dose (LD50) of Methyl methanesulfonate (66-27-3) was considered based on the experimental study conducted by Thompson et al. (Food and Cosmetic Toxicology, Vol.19, pp. 347-351, 1981) 225 mg/kg bw. The study concluded that the LD50 is between 50-300 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Methyl methanesulfonate can be classified as “Category 3” for acute oral toxicity. Acute Inhalation toxicity:  Acute Inhalation toxicity dose (LC50) for Methyl methanesulfonate (66-27-3) was predicted based on OECD QSAR toolbox 22.58 mg/L (22580 mg/m3) and different study available for the structurally similar read across substance Methane sulfonic Acid (CAS no: 75-75-2) >330 ppm (330000 mg/m3). Both these studies concluded that the LC50 value is >5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, Methyl methanesulfonate cannot be classified for acute Inhalation toxicity. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for Methyl methanesulfonate (66-27-3) was predicted based on OECD QSAR toolbox 6926 mg/kg bw and different study available for the closely related read across substance sodium ethenesulfonate (CAS no: 3039-83-6) >2000 mg/kg bw. Both of these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Methyl methanesulfonate cannot be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b26ee86-520b-4301-9ed0-07667f812b88/documents/4973c9e0-754b-4019-9d97-201e8e216007_a7d1f61c-a431-44b4-b7f9-65012b40934c.html,,,,,, Methyl methanesulphonate,66-27-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b26ee86-520b-4301-9ed0-07667f812b88/documents/4973c9e0-754b-4019-9d97-201e8e216007_a7d1f61c-a431-44b4-b7f9-65012b40934c.html,,oral,LD50,225 mg/kg bw,adverse effect observed, Methyl methanesulphonate,66-27-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b26ee86-520b-4301-9ed0-07667f812b88/documents/4973c9e0-754b-4019-9d97-201e8e216007_a7d1f61c-a431-44b4-b7f9-65012b40934c.html,,dermal,LD50,"6,926 mg/kg bw",no adverse effect observed, Methyl methanesulphonate,66-27-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b26ee86-520b-4301-9ed0-07667f812b88/documents/4973c9e0-754b-4019-9d97-201e8e216007_a7d1f61c-a431-44b4-b7f9-65012b40934c.html,,inhalation,LC50,"22,580 mg/m3",no adverse effect observed, "Methyl N-(2,6-dimethylphenyl)-DL-alaninate",52888-49-0," Acute oral toxicity:  Acute oral toxicity dose (LD50) of 2-(2,6-dimethyl-phenylamino)-propionic acid methyl ester (CAS no: 52888-49-0) was predicted based on OECD QSAR toolbox 3419 mg/kg bw and different studies available on structurally similar read across substance 2,6-xylidinium chloride (21436-98-6) 2042 mg/kg bw and for the functionally similar read across substance Methyl-N-methyl anthranilite (CAS No. 85-91-6) >2000 mg/kg body weight. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-(2,6-dimethyl-phenylamino)-propionic acid methyl ester cannot be classified for acute oral toxicity. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for 2-(2,6-dimethyl-phenylamino)-propionic acid methyl ester (CAS no: 52888-49-0) was predicted based on OECD QSAR toolbox 3604 mg/kg bwand differentstudies available for the structurally similar read across substance Methyl N-(2,6-dimethylphenyl)-N-(methoxyacetyl)-DL-alaninate (57837-19-1) >3100 mg/kg bw and for the functionally similar read across substance Methyl-N-methyl anthranilite (CAS No. 85-91-6) >2000 mg/kg body weight. All these studies concluded that the LD50 value is>2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2-(2,6-dimethyl-phenylamino)-propionic acid methyl ester cannot be classified for acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66b5d0be-827e-4621-9ade-80eb556718d2/documents/d922ec4d-4474-4ad4-8da5-a480d1702cc2_7f5fb047-8c92-455f-8891-8f224068f12a.html,,,,,, "Methyl N-(2,6-dimethylphenyl)-DL-alaninate",52888-49-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66b5d0be-827e-4621-9ade-80eb556718d2/documents/d922ec4d-4474-4ad4-8da5-a480d1702cc2_7f5fb047-8c92-455f-8891-8f224068f12a.html,,oral,LD50,"3,419 mg/kg bw",no adverse effect observed, "Methyl N-(2,6-dimethylphenyl)-DL-alaninate",52888-49-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66b5d0be-827e-4621-9ade-80eb556718d2/documents/d922ec4d-4474-4ad4-8da5-a480d1702cc2_7f5fb047-8c92-455f-8891-8f224068f12a.html,,dermal,LD50,"3,604 mg/kg bw",no adverse effect observed, Methyl N-[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate,59709-38-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/84f5c349-7508-42c7-b9e4-edfeffa1ee22/documents/9aaa0804-d079-40cd-9c6e-c5a97264b53e_b23ea3fb-740a-4a91-b3e6-da68950996c4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Methyl N-[4-[(2-bromo-6-chloro-4-nitrophenyl)azo]phenyl]-N-(3-methoxy-3-oxopropyl)-β-alaninate,59709-38-5," The LD50 (oral, gavage, rats) was determined >2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84f5c349-7508-42c7-b9e4-edfeffa1ee22/documents/99dfc19f-fcc6-44bc-9994-3dcb28c689b3_b23ea3fb-740a-4a91-b3e6-da68950996c4.html,,,,,, Methyl o-toluate,89-71-4, Acute oral toxicity of Ylanganate based on read across from methyl p-methyl benzoate (similar to OECD TG 401): LD50 3300 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02f2eab4-a1b9-4c20-bb17-4abe1747963c/documents/IUC5-c87c3760-e871-4590-ac0a-012007be2d46_8932e2ce-478f-4506-bfc4-57b81d786825.html,,,,,, Methyl phenyl sulphide,100-68-5,One key study on acute oral toxicity is available. The study was conducted using female Wistar rats and was conducted according to the Acute Toxic Class Method (OECD Guideline 423). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59f83314-b7ac-4b94-9b37-42825834e4f2/documents/IUC5-e79ecef1-ee9a-450c-9498-cffcc7ab6b67_c40562be-4ab9-4f9f-ad65-ba6be594155e.html,,,,,, Methyl phenyl sulphide,100-68-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59f83314-b7ac-4b94-9b37-42825834e4f2/documents/IUC5-e79ecef1-ee9a-450c-9498-cffcc7ab6b67_c40562be-4ab9-4f9f-ad65-ba6be594155e.html,,oral,LD50,300 mg/kg bw,, Methyl p-hydroxycinnamate,3943-97-3," No data regarding acute toxicity (oral, dermal or inhalation route) is available for Methyl p-hydroxycinnamate . A data regarding acute oral toxicity is available for free acid 2-Propenoic acid, 3-(4-hydroxyphenyl)-, (E)- CAS 501-98-4 (LD 50 oral mouse = 2850 mg/ kg). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc153d80-d97d-4401-b3bf-69528a054de2/documents/1ac49cf0-3d32-4983-baf4-bf6aa7e4df38_00544328-5961-40b2-879c-c89f52dcd78f.html,,,,,, Methyl toluene-4-sulphonate,80-48-8, Acute toxicity: Oral The acute oral LD50 value of the test item PTSM was found to be between 300 and 2000 mg/kg bw in female Crl:WI rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/831ac7d8-9950-48db-8828-79598a9fcc32/documents/4ce68890-a7b7-42d0-8b45-5918f46dd6c4_18bee012-bb27-452e-be08-2af3a22485df.html,,,,,, Methyl toluene-4-sulphonate,80-48-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/831ac7d8-9950-48db-8828-79598a9fcc32/documents/4ce68890-a7b7-42d0-8b45-5918f46dd6c4_18bee012-bb27-452e-be08-2af3a22485df.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Methyl trifluoroacetate,431-47-0, LD50 was estimated to be 4223.56mg/kg bw when male and female Sprague-Dawley rats were exposed with methyl trifluoroacetate (431-47-0) orally. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7718ffa-f976-4e85-9c43-c382fbe59c41/documents/IUC5-9bf1ecd8-d7d3-49b5-8ba5-d4bf64c57128_4b6c7407-5e84-4dd8-bcdc-4d4f3b8ddccd.html,,,,,, Methyl trifluoroacetate,431-47-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7718ffa-f976-4e85-9c43-c382fbe59c41/documents/IUC5-9bf1ecd8-d7d3-49b5-8ba5-d4bf64c57128_4b6c7407-5e84-4dd8-bcdc-4d4f3b8ddccd.html,,oral,LD50,"4,223.56 mg/kg bw",no adverse effect observed, Methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate,10595-49-0," There are two reliable sub-chronic 90-day toxicity studies on the substance, one performed on the rat and one on the dog. There were no treatment related effects in a 90 day sub-chronic feeding study in the rat at doses of up to 3000 ppm in diet (calculated to be approximately equivalent to 279 mg/kg for males and 293 mg/kg for females). Similarly there were no treatment related effects in a 90 day sub-chronic feeding study in the dog at doses of up to 75 mg/kg (top dose limited by the palatability of the substance in the diet). Both of the individual studies have limitations, for example they both preceed standard protocol guidelines and GLP. In addition some aspects of the investigations are limited compared to current protocol standards. However taken together they provide a consistent picture of absence of repeated dose toxicity for this substance. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c5a6952-e191-4e41-9413-158638652654/documents/IUC5-d252daed-3f74-492b-9c13-c63b0fae8843_eec43f69-9cb6-4ba6-85c1-9d3a2c9e8862.html,,,,,, Methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate,10595-49-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c5a6952-e191-4e41-9413-158638652654/documents/IUC5-d252daed-3f74-492b-9c13-c63b0fae8843_eec43f69-9cb6-4ba6-85c1-9d3a2c9e8862.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,286 mg/kg bw/day,,rat Methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate,10595-49-0," There are no reliable acute oral toxicity studies available for the substance itself. There is only an old unreliable study which gave an LD50 of 1770 mg/kg . However, there is a reliable acute oral study on an analogue substance and hence this latter study has been used to address the acute oral toxicity requirement. The analogue substance is of low acute oral toxicity in mammals with an LD50 is > 2350 mg/kg. There are two acute dermal studies available both on the substance. The more recent, reliable study gave an LD50 is > 2000 mg/kg. Testing by the inhalation route is not scientifically justified. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c5a6952-e191-4e41-9413-158638652654/documents/IUC5-7d834e4a-dbd4-408e-97b7-721b4d8acf61_eec43f69-9cb6-4ba6-85c1-9d3a2c9e8862.html,,,,,, Methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate,10595-49-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c5a6952-e191-4e41-9413-158638652654/documents/IUC5-7d834e4a-dbd4-408e-97b7-721b4d8acf61_eec43f69-9cb6-4ba6-85c1-9d3a2c9e8862.html,,oral,LD50,"2,350 mg/kg bw",no adverse effect observed, Methyl trimethyl-3-[(1-oxododecyl)amino]propylammonium sulphate,10595-49-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c5a6952-e191-4e41-9413-158638652654/documents/IUC5-7d834e4a-dbd4-408e-97b7-721b4d8acf61_eec43f69-9cb6-4ba6-85c1-9d3a2c9e8862.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Methyl vinyl ether,107-25-5,"No data are available on the oral or dermal route of exposure (studies technically not feasable).In sub-acute inhalation studies with MVE the NOAEC for male rats was 1500 ppm (3.6 mg/L) and the LOAEC is 3500 ppm (8.4 mg/L) due to systemic effects. In female rats the NOAEC was 3500 ppm (8.4 mg/L) due to local effects on the olfactory epithelium, clinical signs and reduced body weight at 25000 ppm (60 mg/L). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a97349b-8f61-48ac-a03f-707ed0607105/documents/IUC5-724363e0-9bd2-4dc4-81aa-82b65518ebcf_96014ebd-8636-4b34-bc60-40c7ce03a0b8.html,,,,,, Methyl vinyl ether,107-25-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a97349b-8f61-48ac-a03f-707ed0607105/documents/IUC5-724363e0-9bd2-4dc4-81aa-82b65518ebcf_96014ebd-8636-4b34-bc60-40c7ce03a0b8.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"3,600 mg/m3",, Methyl vinyl ether,107-25-5,Data on acute oral toxicity are not available (study technically not feasable; low boiling point).In acute inhalation studies in rats the LC50 (4h) was > 20165 ppm (48 mg/L).The LD50 in acute dermal toxicity studies with cold liquid in rabbits was >5000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a97349b-8f61-48ac-a03f-707ed0607105/documents/IUC5-94c0b21b-bb9a-4419-b5b2-fd7ded3eba38_96014ebd-8636-4b34-bc60-40c7ce03a0b8.html,,,,,, Methyl α-D-mannopyranoside,617-04-9,"No treatment-related adverse effects were observed in the combined repeated dose oral toxicity and reproduction/ developmental toxicity screening test with the test substance in male and female Wistar rats with dose levels of 100, 300, and 1000 mg/kg bw/day (reference 7.5.1-1). Thus, the NOAEL for general toxicity is determined to be 1000 mg/kg bw/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The test procedure was in accordance with generally accepted scientific standards and described in sufficient detail. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/149d07b1-95cc-414a-96e9-9e154107360e/documents/a0edb693-deda-4ea9-9948-d126ab913ebc_59bdb1a9-46d4-41c0-b24f-5df1e7a507c8.html,,,,,, Methyl α-D-mannopyranoside,617-04-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/149d07b1-95cc-414a-96e9-9e154107360e/documents/a0edb693-deda-4ea9-9948-d126ab913ebc_59bdb1a9-46d4-41c0-b24f-5df1e7a507c8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Methyl α-D-mannopyranoside,617-04-9,"The test item has no acute toxic potential under the conditions of the present study, and the LD50 value is higher than 2000 mg/kg body weight after single oral administration in female rats (reference 7.2.1-1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The quality of the experimental study is sufficient as it was conducted according to guideline and under GLP. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/149d07b1-95cc-414a-96e9-9e154107360e/documents/46420573-d132-4adc-834c-080003d7e436_59bdb1a9-46d4-41c0-b24f-5df1e7a507c8.html,,,,,, Methyl α-D-mannopyranoside,617-04-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/149d07b1-95cc-414a-96e9-9e154107360e/documents/46420573-d132-4adc-834c-080003d7e436_59bdb1a9-46d4-41c0-b24f-5df1e7a507c8.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Methyl-1H-benzotriazole,29385-43-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study is a well conducted GLP-Study following the OECD-Guideline ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe4be62f-6c22-4eb1-8577-2ca90e03b2d4/documents/IUC5-f91d1403-ddc1-4311-a58f-cac8625e9dd1_31af1226-42cf-424c-a647-2a38d2e577d7.html,,,,,, Methyl-1H-benzotriazole,29385-43-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe4be62f-6c22-4eb1-8577-2ca90e03b2d4/documents/IUC5-f91d1403-ddc1-4311-a58f-cac8625e9dd1_31af1226-42cf-424c-a647-2a38d2e577d7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Methyl-1H-benzotriazole,29385-43-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe4be62f-6c22-4eb1-8577-2ca90e03b2d4/documents/IUC5-f91d1403-ddc1-4311-a58f-cac8625e9dd1_31af1226-42cf-424c-a647-2a38d2e577d7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Methyl-1H-benzotriazole,29385-43-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe4be62f-6c22-4eb1-8577-2ca90e03b2d4/documents/IUC5-38b5319c-9e71-4c12-be2d-847fd6990411_31af1226-42cf-424c-a647-2a38d2e577d7.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, Methyl-1H-benzotriazole,29385-43-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe4be62f-6c22-4eb1-8577-2ca90e03b2d4/documents/IUC5-38b5319c-9e71-4c12-be2d-847fd6990411_31af1226-42cf-424c-a647-2a38d2e577d7.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Methylamine,74-89-5," Oral: Munley S.M., 2007: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test in Rats, gavage (0, 250, 500, 1000 mg methylamine hydrochloride/kg bw/day). Oral: Sarkar, S. N. and Sastry, M.S. Chronic toxicity of methylamine on oral administration and feed contamination in rats., 1990; rats, gavage (10 mg/kg bw/day) and via diet (100 mg/kg bw/ day), up to 90 days. (Diet is a more relevant application route for humans than gavage). Inhalation: Sriramachari et al., 1994, Comparative toxicity of methyl isocyanate and its hydrolytic derivatives in rats, rats inhalation or subcutaneous injection; 19 µmole or 5.75 mmol/kg respectively, 4 weeks / up to 10 weeks, no NOAEC could be identified because of only one dose level tested Inhalation: Kinney et al, 1990, Inhalation toxicology of Methylamine, rats inhalation, 75 ppm, 250 ppm, 750 ppm, 2 weeks: NOAEC (local effects) = 75 ppm = 96 mg/m³; LOAEC (systemic effects) = 250 ppm = 322 mg/m³ ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5583ab9a-382a-4483-a36f-b428c1a3b074/documents/IUC5-68ad798f-e4b7-44e3-abd0-65e39db1b48d_ae2f2c16-823b-4edd-969e-adac4f43cc32.html,,,,,, Methylamine,74-89-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5583ab9a-382a-4483-a36f-b428c1a3b074/documents/IUC5-68ad798f-e4b7-44e3-abd0-65e39db1b48d_ae2f2c16-823b-4edd-969e-adac4f43cc32.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Methylamine,74-89-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5583ab9a-382a-4483-a36f-b428c1a3b074/documents/IUC5-68ad798f-e4b7-44e3-abd0-65e39db1b48d_ae2f2c16-823b-4edd-969e-adac4f43cc32.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,322 mg/m3,,rat Methylamine,74-89-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5583ab9a-382a-4483-a36f-b428c1a3b074/documents/IUC5-68ad798f-e4b7-44e3-abd0-65e39db1b48d_ae2f2c16-823b-4edd-969e-adac4f43cc32.html,Repeated dose toxicity – local effects,inhalation,NOAEC,96 mg/m3,adverse effect observed,rat Methylamine,74-89-5," Acute oral toxicity: BASF AG, Bericht ueber die Pruefung der akuten oralen Toxizitaet, Report Nr. 82/0162, 1982; similar to the OECD Gudeline 401, Wistar rats, 215, 464 and 825 mg/kg bw. Acute inhalation toxicity: BASF AG, Akute Inhalationstoxizitaet LC50 4 (Ratte) Stunden Dampfversuch von ""Monoethylamin"", (report No. 82/0234) equivalent or similar to OECD 403; rats, doses: 4.5, 2.9, 2.1, 0.72 mg/L, whole body exposure for 4 hours; ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5583ab9a-382a-4483-a36f-b428c1a3b074/documents/IUC5-4a68d755-5656-4224-9b25-5cf934a3a6fb_ae2f2c16-823b-4edd-969e-adac4f43cc32.html,,,,,, Methylamine,74-89-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5583ab9a-382a-4483-a36f-b428c1a3b074/documents/IUC5-4a68d755-5656-4224-9b25-5cf934a3a6fb_ae2f2c16-823b-4edd-969e-adac4f43cc32.html,,oral,LD50,698 mg/kg bw,adverse effect observed, Methylamine,74-89-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5583ab9a-382a-4483-a36f-b428c1a3b074/documents/IUC5-4a68d755-5656-4224-9b25-5cf934a3a6fb_ae2f2c16-823b-4edd-969e-adac4f43cc32.html,,inhalation,LC50,"2,100 mg/m3",adverse effect observed, Methylcyclohexane,108-87-2,"Oral: NOAEL (28 days, rat) = 250 mg/kg bw/day (OECD 422, GLP, target organ: kidney, male rat specific)Inhalation: NOAEC (1 year, rat) = 1600 mg/m³ (target organ: kidney, male rat specific) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca5c129c-2cd8-4244-aed5-a67c13376610/documents/IUC5-2384a0e8-2abb-48fa-a37c-be85681c160c_6c3d8fb6-387c-44de-8195-e6b7363a6b95.html,,,,,, Methylcyclohexane,108-87-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca5c129c-2cd8-4244-aed5-a67c13376610/documents/IUC5-2384a0e8-2abb-48fa-a37c-be85681c160c_6c3d8fb6-387c-44de-8195-e6b7363a6b95.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Methylcyclohexane,108-87-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca5c129c-2cd8-4244-aed5-a67c13376610/documents/IUC5-2384a0e8-2abb-48fa-a37c-be85681c160c_6c3d8fb6-387c-44de-8195-e6b7363a6b95.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,600 mg/m3",,rat Methylcyclohexane,108-87-2,"Oral:Minimum lethal dose (rabbit) = 4000-4500 mg/kg bwLD50 (mouse) = 2250 mg/kg bwLD50 (rat) > 3200 mg/kg bw (technical product, 70% pure)Aspiration toxicity based on kinematic viscosity (0.88 mm²/s at 20°C)Dermal:LD50 (rabbit) > 2300 mg/kg bw (similar to OECD 402, read-across from cyclohexane and mass correction)Inhalation:Minimum lethal concentration (mouse) = 40-50 mg/L (2 h exposure)Minimum lethal concentration (rabbit) = 28.75 mg/L (mortality after 2-week exposure, 6 h/day)LC50 (mouse) = 41 mg/L (2 h exposure)LC50 (rat/mouse) > 26.3 mg/L (1 h exposure)LC50 (dog) > 16.3 mg/L (1 h exposure)LC0 (rat) = 11 mg/L (6 h exposure, technical product, 70% pure )Minimum narcotic concentration (rat/mouse) = 26.3 mg/L (1 h exposure)Minimum narcotic concentration (rabbit) = 21.90 mg/L (6 h exposure)One-hour emergency exposure limit (rat, mouse, dog) = 16 mg/L (1 h exposure) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca5c129c-2cd8-4244-aed5-a67c13376610/documents/IUC5-11dc45ae-06ed-4e0d-9d75-7a7df37f85b5_6c3d8fb6-387c-44de-8195-e6b7363a6b95.html,,,,,, Methylcyclohexane,108-87-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca5c129c-2cd8-4244-aed5-a67c13376610/documents/IUC5-11dc45ae-06ed-4e0d-9d75-7a7df37f85b5_6c3d8fb6-387c-44de-8195-e6b7363a6b95.html,,inhalation,discriminating conc.,"16,000 mg/m3",adverse effect observed, Methylcyclopentadiene,26472-00-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91ee5234-aafb-47bc-891e-0857967bf3b5/documents/IUC5-735d3185-5660-4cb9-9f76-a50fb8b500c1_159f0168-951e-40aa-8042-163bf77164f0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat Methylcyclopentadiene,26472-00-4,- Acute toxicity:Inhalation: LD50: > 495 ppm for rat (limit test). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91ee5234-aafb-47bc-891e-0857967bf3b5/documents/IUC5-1ffedd6d-86e7-4240-a243-29c455384d05_159f0168-951e-40aa-8042-163bf77164f0.html,,,,,, Methylcyclopentadiene,26472-00-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91ee5234-aafb-47bc-891e-0857967bf3b5/documents/IUC5-1ffedd6d-86e7-4240-a243-29c455384d05_159f0168-951e-40aa-8042-163bf77164f0.html,,inhalation,LC50,495 mg/m3,, Methylcyclopentane,96-37-7,"Oral A 28-day oral toxicity study with two dose groups (500 and 2000 mg/kg bw/d) of methylcyclopentane was performed in rats. Although indiviual results on the test substance are only available for mortality, body and kidney weights, the study was peer reviewed by the EPA and a NOAEL of 357 mg/kg bw/d was assessed.   Inhalation One study in subchronic inhalation toxicity of methylcyclopentane was performed in Sprague-Dawley rats. Four groups of 10 rats of each gender were exposed to methylcyclopentane vapor by whole-body inhalation at concentrations of 0, 290, 1300, or 5870 ppm for 6 h per day, 5 days/ week over a 13-week period. During the study period, clinical signs, mortality, body weight, food consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, gross pathology, organ weights, and histopathology were examined. Exposure-related clinical signs (salivation and rubbing) were observed in both genders of the 5870 ppm group. There was an increase in liver weight for both genders, but the kidney weight was only higher in females than controls. However, no toxicologically significant changes were observed in body weight, food consumption, ophthalmoscopy, urinalysis, hematology, serum biochemistry, necropsy findings, or histopathology in any of the treatment groups. Under theexperimental conditions, the target organs were determined to be kidney and liver in rats. The no-observed-adverse-effect concentration was considered to be 1300 ppm/day (4.47 mg/l) in rats.   Dermal Testing by the dermal route is not needed because exposure of humans via inhalation is the relevant route taking into account the vapor pressure of the substance and/or the possibility of exposure to aerosols, or droplets of an inhalable size. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ec2cf67-87dc-4853-bc09-6a8f16eb48e8/documents/0e00a72f-cc69-405c-ac55-015eb58cca03_4f0cf960-56c2-4638-900e-51328b3cbaa2.html,,,,,, Methylcyclopentane,96-37-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ec2cf67-87dc-4853-bc09-6a8f16eb48e8/documents/0e00a72f-cc69-405c-ac55-015eb58cca03_4f0cf960-56c2-4638-900e-51328b3cbaa2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,357 mg/kg bw/day,,rat Methylcyclopentane,96-37-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ec2cf67-87dc-4853-bc09-6a8f16eb48e8/documents/0e00a72f-cc69-405c-ac55-015eb58cca03_4f0cf960-56c2-4638-900e-51328b3cbaa2.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,4.47 mg/L,,rat Methylcyclopentane,96-37-7,"Oral No acute toxicity study is available, but a 28-day oral toxicity study with two dose groups (500 and 2000 mg/kg bw/d) of methylcyclopentane was performed in rats. The LD50 was greater than 2000 mg/kg bw, but 4 out of 10 animals died at this dose level in repeated dose testing.   Inhalation Again, no acute toxicity study is available, but a subchronic inhalation toxicity study of methylcyclopentane in Sprague-Dawley rats was performed. Four groups of 10 rats of each gender were exposed to methylcyclopentane vapor by whole-body inhalation at concentrations of 0, 290, 1300, or 5870 ppm (i.e. 0, 1, 4.47 and 20.21 mg/l, respectively) for 6h per day, 5 days/week over a 13-week period. Neither mortality, nor acute clinical signs, acute body weight changes or treatment-related gross findings were observed.   Dermal A study was not conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ec2cf67-87dc-4853-bc09-6a8f16eb48e8/documents/25f83338-cf53-4d2b-9ee3-4c23ff246658_4f0cf960-56c2-4638-900e-51328b3cbaa2.html,,,,,, Methylcyclopentane,96-37-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ec2cf67-87dc-4853-bc09-6a8f16eb48e8/documents/25f83338-cf53-4d2b-9ee3-4c23ff246658_4f0cf960-56c2-4638-900e-51328b3cbaa2.html,,oral,LD50,"> 2,000 mg/kg bw",adverse effect observed, Methylcyclopentane,96-37-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ec2cf67-87dc-4853-bc09-6a8f16eb48e8/documents/25f83338-cf53-4d2b-9ee3-4c23ff246658_4f0cf960-56c2-4638-900e-51328b3cbaa2.html,,inhalation,LC50,> 20.21 mg/L,no adverse effect observed, methylethylketone peroxide trimer,24748-23-0,A well-conducted 28-day and 90-day repeated dose toxicity study were available. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aec80d3e-876a-405c-b5e0-4998d62b3c8f/documents/IUC5-6dcd977f-1ab2-4ac4-8a06-bb5c2ce78835_0a59353b-1e67-479b-bdc1-8b34cd36adb6.html,,,,,, methylethylketone peroxide trimer,24748-23-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aec80d3e-876a-405c-b5e0-4998d62b3c8f/documents/IUC5-6dcd977f-1ab2-4ac4-8a06-bb5c2ce78835_0a59353b-1e67-479b-bdc1-8b34cd36adb6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat methylethylketone peroxide trimer,24748-23-0,Two acute oral toxicity studies were available. The LD50 in both studies exceeds 2000 mg/kg. One acute dermal toxicity study was available. The LD50 exceeds 2000 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aec80d3e-876a-405c-b5e0-4998d62b3c8f/documents/IUC5-9ca01407-dd18-48da-af4a-a8b59d86d4c5_0a59353b-1e67-479b-bdc1-8b34cd36adb6.html,,,,,, methylpentane,43133-95-5,"Two key 90 day repeat dose inhalation studies were conducted for commercial hexane (API, 1990; Klimisch score =2). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3875d60-95d6-4029-89c1-a719500eff0c/documents/IUC5-f8fca34a-b774-4f96-a4b8-e45aff25e6ea_1b6c89af-cba1-42ba-8dd7-91a6c4a333d6.html,,,,,, methylpentane,43133-95-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3875d60-95d6-4029-89c1-a719500eff0c/documents/IUC5-f8fca34a-b774-4f96-a4b8-e45aff25e6ea_1b6c89af-cba1-42ba-8dd7-91a6c4a333d6.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,"10,504 mg/m3",,rat methylpentane,43133-95-5,"Key read across studies of C-6 normal and iso paraffins (hexanes) and naphthenes (methyl-cyclohexane, dimethylcyclohexane), 25-35% n-hexane (Hine et al., 1970; Klimisch score=2) were identified to support each acute toxicity endpoint (oral, dermal, and inhalation) for this substance.Acute Toxicity-Oral LD50>16750 mg/kg in rats (OECD TG 401)Acute Toxicity-Dermal LD50>3350 mg/kg in rabbits (OECD TG 402)Acute Toxicity-Inhalation LC50>259354 mg/m3 in rats (OECD TG 403) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3875d60-95d6-4029-89c1-a719500eff0c/documents/IUC5-e12bde3d-06ee-4250-9ca7-45d200ddf320_1b6c89af-cba1-42ba-8dd7-91a6c4a333d6.html,,,,,, methylpentane,43133-95-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3875d60-95d6-4029-89c1-a719500eff0c/documents/IUC5-e12bde3d-06ee-4250-9ca7-45d200ddf320_1b6c89af-cba1-42ba-8dd7-91a6c4a333d6.html,,oral,LD50,"16,750 mg/kg bw",, methylpentane,43133-95-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3875d60-95d6-4029-89c1-a719500eff0c/documents/IUC5-e12bde3d-06ee-4250-9ca7-45d200ddf320_1b6c89af-cba1-42ba-8dd7-91a6c4a333d6.html,,dermal,LD50,"3,350 mg/kg bw",, methylpentane,43133-95-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3875d60-95d6-4029-89c1-a719500eff0c/documents/IUC5-e12bde3d-06ee-4250-9ca7-45d200ddf320_1b6c89af-cba1-42ba-8dd7-91a6c4a333d6.html,,inhalation,LC50,"259,354 mg/m3",, Methylpentynol,77-75-8,LD50 (oral): >300<800 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c679b06-328b-4e10-9c5d-83729cbea08b/documents/IUC5-1df3850b-505f-4fb9-a966-d994d0fb3279_a69b4688-5560-4cd1-84ed-1f5c0a0887a5.html,,,,,, Methylphosphonic acid,993-13-5," The key study used to cover this endpoint is a 90-day oral gavage study with the test substance MPAAU. MPAAU data are used and considered acceptable for read-across to MPA since the target substance methylphosphonic acid is highly corrosive and cannot be applied to animals in a repeated dosing scheme. Therefore, the neutralized salt form of this chemical is used to conduct the test. Details on the read-across applied can be read in the read-across justification document attached to this dossier. MPAAU was tested up to 1000 mg/kg bw /day in rats in the 90-day oral gavage study and no adverse effects were observed. As MPAAU did not induce any changes that were considered to be of toxicological significance in this study, the no-observed-adverse-effect level (NOAEL) was placed at 1000 mg/kg body weight/day. Therefore, a NOAEL of 1000 mg/kg bw/day should be applied to MPA. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/997977b3-c6cd-4749-b9b2-124584e78da4/documents/IUC5-debfe961-636a-4ffb-a279-f41cb9a8ecfe_78eb1418-40d8-4aec-b07a-2e85c85ca304.html,,,,,, Methylphosphonic acid,993-13-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/997977b3-c6cd-4749-b9b2-124584e78da4/documents/IUC5-debfe961-636a-4ffb-a279-f41cb9a8ecfe_78eb1418-40d8-4aec-b07a-2e85c85ca304.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Methylphosphonic acid,993-13-5,Acute oral toxicity: LD50 (male/female) rat: 1888 mg/kg bw; LD50 (female) rat:1760 mg/kg bw; LD50 (male) rat: 2005 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/997977b3-c6cd-4749-b9b2-124584e78da4/documents/IUC5-33095603-0894-476c-90b2-73ac20281be3_78eb1418-40d8-4aec-b07a-2e85c85ca304.html,,,,,, Methylphosphonic acid,993-13-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/997977b3-c6cd-4749-b9b2-124584e78da4/documents/IUC5-33095603-0894-476c-90b2-73ac20281be3_78eb1418-40d8-4aec-b07a-2e85c85ca304.html,,oral,LD50,"1,888 mg/kg bw",adverse effect observed, "Methylphosphonic acid, compound with amidinourea (1:1)",84402-58-4," RD oral: NOAEL (rat) = 1000 mg/kg bw/day (OECD 407); no hazard identified; RC not required RD oral: NOAEL (rat) = 1000 mg/kg bw/day (OECD 408) 25 June 2018; no hazard identified; no DNEL necessary RD dermal: waived (scientifically not justified), WoE: no classification necessary; no DNEL necessary RD inhalation: waived (exposure considerations), WoE: no classification necessary; no DNEL necessary ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d01cf725-a67c-497f-adb4-6143068196ff/documents/IUC5-298836b3-bd23-47d6-9de0-15de5bc94939_fabc70b7-7d6c-46f4-988a-bad0f2895de1.html,,,,,, "Methylphosphonic acid, compound with amidinourea (1:1)",84402-58-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d01cf725-a67c-497f-adb4-6143068196ff/documents/IUC5-298836b3-bd23-47d6-9de0-15de5bc94939_fabc70b7-7d6c-46f4-988a-bad0f2895de1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Methylphosphonic acid, compound with amidinourea (1:1)",84402-58-4,"LD50, oral > 2500 mg/kg bwacute Tox. dermal: test waived (scientifically not justified: not hazardous)acute Tox. inhalation: test waived (limited exposure) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d01cf725-a67c-497f-adb4-6143068196ff/documents/IUC5-372ee938-07d7-4d0c-b17c-bafe23b8dd78_fabc70b7-7d6c-46f4-988a-bad0f2895de1.html,,,,,, "Methylphosphonic acid, compound with amidinourea (1:1)",84402-58-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d01cf725-a67c-497f-adb4-6143068196ff/documents/IUC5-372ee938-07d7-4d0c-b17c-bafe23b8dd78_fabc70b7-7d6c-46f4-988a-bad0f2895de1.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Methylsilanetriyl triacetate,4253-34-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Reliable guideline study for the oral route (read across) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e7610a7-75d0-4d44-9ae4-f9f2f2089747/documents/4edb5d75-79f1-4e8c-ba4b-d9f361e4800f_def158e9-68b5-4f94-834c-902e522fab4b.html,,,,,, Methylsilanetriyl triacetate,4253-34-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e7610a7-75d0-4d44-9ae4-f9f2f2089747/documents/4edb5d75-79f1-4e8c-ba4b-d9f361e4800f_def158e9-68b5-4f94-834c-902e522fab4b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,232 mg/kg bw/day,,rat Methylsilanetriyl triacetate,4253-34-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e7610a7-75d0-4d44-9ae4-f9f2f2089747/documents/115210da-eade-45d0-8d96-7b4a8b4d3a0f_def158e9-68b5-4f94-834c-902e522fab4b.html,,oral,LD50,"1,600 mg/kg bw",adverse effect observed, Methylthiouracil,56-04-2, LD50 (oral) 2500 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bcc44b1-eea0-46de-b3b4-e8a7ebcbe09a/documents/260b2477-a2c3-4976-a1f5-b3da090beaf9_6c2d1285-9aa9-4637-85bc-6b144ddf5cb3.html,,,,,, Methylthiouracil,56-04-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bcc44b1-eea0-46de-b3b4-e8a7ebcbe09a/documents/260b2477-a2c3-4976-a1f5-b3da090beaf9_6c2d1285-9aa9-4637-85bc-6b144ddf5cb3.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Methyltrioctylammonium chloride,5137-55-3," Repeated dose toxcity: Oral Based on the data available for the target chemical and its read across chemical, Methyl(trioctyl)azanium chloride (CAS no 5137 -55 -3) is not likely to be toxic as per the criteria mentioned in CLP regulation.If however the content of CAS # 68814-95 -9 (STOT RE Cat. 1 for effects on the heart) is at or greater than 1 % (but less than 10 %), a classification withSTOT RE Cat. 2 for potential effects on the heart is warranted.   Repeated dose toxicity: Inhalation Methyltricaprylyl Ammonium Chloride (CAS no 5137-55-3) has very low vapor pressure (2.5E-010 Pa.). So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the end point for repeated dose toxicity by the inhalation route was considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value for Methyltricaprylyl Ammonium Chloride (CAS no 5137 -55 -3) (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not sensitizing to the skin. Based on these considerations, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47f28a8d-a5cd-4b34-b084-1adcf1e71fb4/documents/4c421b7b-48ec-48c7-bec0-b22b4966f97f_69e4ff3b-efad-4844-815c-136b147aa094.html,,,,,, Methyltrioctylammonium chloride,5137-55-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47f28a8d-a5cd-4b34-b084-1adcf1e71fb4/documents/4c421b7b-48ec-48c7-bec0-b22b4966f97f_69e4ff3b-efad-4844-815c-136b147aa094.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,mouse Methyltrioctylammonium chloride,5137-55-3," Acute Oral Toxicity:  In Acute oral toxicity,LD50 value for target substance Methyltricaprylyl Ammonium Chloride (5137-55-3) was considered to be 223 mg/kg bw in rats and 280 mg/kg bw in mice,and for differentstudies available on the structurally similar read across substancewas considered in the range of 250-300 mg/kg bw in rats. All these studies concluded that the LD50 value is between 50-300 mg/kg bw.Thus, comparing this value with the criteria of CLP regulation, Methyltricaprylyl Ammonium Chloride (5137-55-3) can be classified as category III of acute oral toxicity. Acute Inhalation Toxicity:  Methyltricaprylyl Ammonium Chloride (5137-55-3) has very low vapor pressure (2.5E-010 Pa.).So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver. Acute Dermal Toxicity: The acute dermal toxicity dose (LD50) for Methyltricaprylyl Ammonium Chloride (5137-55-3) was based on data available for the structurally similar read across chemicals. The LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Methyltricaprylyl Ammonium Chloride (5137-55-3) cannot be classified for acute dermal toxicity.  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47f28a8d-a5cd-4b34-b084-1adcf1e71fb4/documents/c8af9b0b-613f-44cd-b13b-3393d68de047_69e4ff3b-efad-4844-815c-136b147aa094.html,,,,,, Methyltrioctylammonium chloride,5137-55-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47f28a8d-a5cd-4b34-b084-1adcf1e71fb4/documents/c8af9b0b-613f-44cd-b13b-3393d68de047_69e4ff3b-efad-4844-815c-136b147aa094.html,,oral,LD50,223 mg/kg bw,adverse effect observed, Methyltrioctylammonium chloride,5137-55-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47f28a8d-a5cd-4b34-b084-1adcf1e71fb4/documents/c8af9b0b-613f-44cd-b13b-3393d68de047_69e4ff3b-efad-4844-815c-136b147aa094.html,,dermal,LD50,"6,818.27 mg/kg bw",no adverse effect observed, Methyl-tris acetonoximo-silane,2594-75-4," No data is available to assess the acute oral toxicity of the target substance Methyl-tris acetonoximo-silane. Thus, available data from a suitable read-across partner are used. In an acute oral toxicity study (OECD 423) with 2-propanone, 2,2’,2”-[O,O’,O”-(ethylsilylidyne)trioxime] no mortality has been reported at a dose of 2500 mg/kg bw. Thus, the oral LD50 can considered to be greater than 2500 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a158a71d-72b0-444e-98c6-61279872fa78/documents/a022ed10-ed4b-4d3d-b88e-f4417cc6fe38_855824b1-4fa8-4b7e-8d86-1d24d1adf9a3.html,,,,,, Metoclopramide,364-62-5," Two acute oral toxicity values are available, as secondary source, for metoclopramide: mouse, LD50, oral = 270 mg/kg rat, LD50, oral = 750 mg/kg. Even if the LD50 for mouse trigger to the classification as Acute Tox. 3, as stated in CLP Regulation the preferred test species for evaluation of acute toxicity by the oral and inhalation routes is the rat. Therefore, the substance is classified as Acute Tox. 4 H302. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58fec4f4-fd1b-407e-9f35-6d9c92e00dce/documents/2e1c85a5-8681-49a8-9a5e-a846377f1745_575a0645-f203-4024-8c27-499983f5914e.html,,,,,, Metoclopramide,364-62-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58fec4f4-fd1b-407e-9f35-6d9c92e00dce/documents/2e1c85a5-8681-49a8-9a5e-a846377f1745_575a0645-f203-4024-8c27-499983f5914e.html,,oral,LD50,750 mg/kg bw,adverse effect observed, Metronidazole,443-48-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Data Source: USP Reference Standards - Catalog Number: 1442009, European Directorate for the Quality of Medicines & HealthCare (EDQM) - Catalogue code: M1850000, ChemIDplus Lite ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c104d57-d688-4f49-a311-f85d02aaf92c/documents/5b175a99-cbff-4d01-bcb9-d703d964734a_84f7099c-c629-4617-a3c7-930b6430de28.html,,,,,, Metronidazole,443-48-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c104d57-d688-4f49-a311-f85d02aaf92c/documents/5b175a99-cbff-4d01-bcb9-d703d964734a_84f7099c-c629-4617-a3c7-930b6430de28.html,,oral,LD50,"3,000 mg/kg bw",, Midazolam,59467-70-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fbff0766-7ba5-49ec-96a2-51ad07d27311/documents/a2254bf6-fdfe-4366-8bd6-7861131bdfba_e29a7ce3-7be9-49bd-9315-15372f5e37a7.html,,oral,LD50,362 mg/kg bw,adverse effect observed, Mill scale (ferrous metal),65996-74-9,"Repeated dose toxicity -  oral: The iron oxides, show a complete absence of adverse effects in guideline compliant repeated dose toxicity studies via the oral route. Neither macroscopic, nor microscopic findings were noted. These findings were seen in a sub-chronic oral study in rats with three different iron oxides. An NOAEL was not derived based on the absence of adverse effects up to the limit dose of 1000 mg/kg bw/day. A number of sub-chronic oral repeated dose toxicity studies with iron show a substantial variability in the effect doses (NOAEL range from 68 to 1300 mg Fe/kg bw/day, with a mean of 390 mg Fe/kg bw/day). The effects described were mild increase in relative liver weight and increase in liver non-haeme Fe. In a double-blind clinical trial some very mild effects are described after treatment of anaemic patients with iron (powder) as food supplement at 1800 mg Fe/day for three weeks. The treatment was generally well-tolerated with transient gastrointestinal side effects comparable to the effects seen with soluble iron salts. A comparative group of patients was treated with a soluble iron salt at 180 mg Fe/day, very similar effects were observed compared with the iron-treated group. This data shows an approx. 10-fold lower toxicity for iron compared with soluble iron salts. For comparative purposes, toxicological data on soluble iron salts were included in this dossier The sub-acute animal studies with soluble iron salts (e.g. iron sulfate, iron chloride and iron tartrate) indicate an effect dose of 60-180 mg Fe/kg bw/day based on increased liver weights and inflammatory parameters in the gastro-intestinal tract. The effects in the gastro-intestinal tract are also identified as lead-effect in the human studies, where effect levels of 60-200 mg Fe are described. The lower effect levels for highly soluble and highly bioavailable iron substances compared to the higher effect level for iron for both in animals and humans, corroborates the assumption that solubility in water or artificial body fluids correlates with the systemic toxicity of the iron category substances.   Repeated dose toxicity - inhalation: The existing 28-day and 90-day inhalation studies with iron oxides in rats does not show any substance-related adverse effects. The effects of iron oxides after 28-day and 90-day inhalation is best compared with the effects seen with other poorly-soluble low-toxicity particles (PSLT), leading to a minimal or mild inflammatory response only at the maximum tolerated concentration in repeated dose toxicity studies via inhalation. Furthermore, in human epidemiological studies following prolonged inhalation exposure, no clinically significant adverse local or systemic effects were reported. Based on the physico-chemical properties of the particles, direct systemic exposure to iron upon inhalation can be ruled out. Based on the local effects particles can have in the respiratory tract and the physico-chemical properties of carbonyl iron, it is not expected that a longer duration would result in the detection of other effects, not solely determined by the PSP character of carbonyl iron.   Repeated dose toxicity – dermal: There is no information available on dermal toxicity. The conduct of repeated dose toxicity study is not considered to be required since inhalation of the substance is considered the most relevant route of human exposure. Furthermore, physicochemical and toxicological properties of the iron category substances do not suggest a significant rate of absorption through the skin (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55e65aaa-5e4f-486f-af5a-41072fff53e3/documents/cfa225fa-6979-4fbb-b685-cc839df1b5f9_69ca9cb4-7735-4ad1-9552-8ceafdca6e16.html,,,,,, Mill scale (ferrous metal),65996-74-9,"Acute oral toxicity: LD50 > 5000mg/kg bw Acute toxicity, inhalation: LC50 > 5 mg/L Acute toxicity, dermal: There is no information available on acute dermal toxicity but a long history of safe use. In addition, the conduct of acute dermal toxicity testing is not considered to be required since inhalation of the substance is considered the most relevant route of human exposure. Furthermore, physicochemical and toxicological properties of the substance do not suggest a significant rate of absorption through the skin (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): There is no key study available, therefore the acute oral toxicity of the substance was assessed in a weight of evidence approach. One OECD 401 (1981) study with minor restrictions (RL=2) utilizing a test substance containing 73% Fe2O3 was supported by 4 additional studies with insufficient documentation utilizing Fe2O3, FeO(OH), or Fe3O4 up to 10 mg/kg bw. Despite the insufficient documentation, all supportive studies were executed by an established toxicological test centre and therefore can be considered to be relevant. Fe2O3 and Fe3O4 are the main constituents of the substance to be assessed. The overall quality of the database is therefore sufficient. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): There is no key study available, therefore the acute oral toxicity of the substance was assessed in a weight of evidence approach. One study with minor restrictions (RL=2) equvilant to OECD403 utilizing a test substance Fe3O4 (0.64 mg/L maximum attainable concentration) was supported by one additional studies with insufficient documentation utilizing Fe2O3 exposing rats to 2100 mg/m³ and hamster to 2800 mg/m³ for 12 hours. Fe2O3 and Fe3O4 are the main constituents of the substance to be assessed. The overall quality of the database is therefore sufficient. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55e65aaa-5e4f-486f-af5a-41072fff53e3/documents/873dae82-73b1-4142-890a-721a8f825229_69ca9cb4-7735-4ad1-9552-8ceafdca6e16.html,,,,,, "MIXTURE OF 2-(2,2,7,7-TETRAMETHYLTRICYCLO[6.2.1.0((1,6)]UNDEC-5-EN-5-YL)PROPAN-1-OL AND 2-(2,2,7,7-TETRAMETHYLTRICYCLO[6.2.1.0(1,6)]",1001252-30-7,"NOAELsystemic toxicity ≥ 1000 mg/kg bw/day in rats of both sexes. (OECD 407, GLP - 2007) NOAELparental systemic toxicity, female rats ≥ 800 mg/kg/day (OECD 421, GLP - 2022) NOAELparental systemic toxicity, male rats = 200 mg/kg/day (OECD 421, GLP - 2022) Although the OECD 421 study does not examine all parameters required in a full repeated dose toxicity study, similar systemic effects and in particular the non-adverse adaptive liver induction, were observed in both OECD 407 and OECD 421. However, in the OECD 421 the adversity threshold was reached for the liver findings (hepatocellular necrosis and inflammation) in some males (7/10) at the high dose of 800mg/kg/d. As such, the NOAEL for male parental toxicity of 200 mg/kg/d from the OECD 421 is used as key value for the chemical safety assessment, as it represent the worst case. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a93acfc-8787-4b63-9a50-55137ee324fd/documents/d23821db-0ff4-4ce3-8f36-029922417c6a_bbe9ee5c-42a6-40cb-857d-00fb2e7ff31b.html,,,,,, "MIXTURE OF 2-(2,2,7,7-TETRAMETHYLTRICYCLO[6.2.1.0((1,6)]UNDEC-5-EN-5-YL)PROPAN-1-OL AND 2-(2,2,7,7-TETRAMETHYLTRICYCLO[6.2.1.0(1,6)]",1001252-30-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a93acfc-8787-4b63-9a50-55137ee324fd/documents/d23821db-0ff4-4ce3-8f36-029922417c6a_bbe9ee5c-42a6-40cb-857d-00fb2e7ff31b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "MIXTURE OF 2-(2,2,7,7-TETRAMETHYLTRICYCLO[6.2.1.0((1,6)]UNDEC-5-EN-5-YL)PROPAN-1-OL AND 2-(2,2,7,7-TETRAMETHYLTRICYCLO[6.2.1.0(1,6)]",1001252-30-7,"Oral Oral LD50 cut-off ≥ 5000 mg/kg bw (OECD 423, K, Rel.1, Acute Toxic Class Method)  Inhalation 1.14 mg/L < LC504-hours < 5.18 mg/L (OECD Guideline 436 (Acute Inhalation Toxicity: Acute Toxic Class Method)) Dermal Dermal LD50 > 2000 mg/kg bw (OECD Guideline 402 (Acute Dermal Toxicity) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a93acfc-8787-4b63-9a50-55137ee324fd/documents/84bc78a2-5f05-4c67-be35-b80d09dc8a76_bbe9ee5c-42a6-40cb-857d-00fb2e7ff31b.html,,,,,, "MIXTURE OF 2-(2,2,7,7-TETRAMETHYLTRICYCLO[6.2.1.0((1,6)]UNDEC-5-EN-5-YL)PROPAN-1-OL AND 2-(2,2,7,7-TETRAMETHYLTRICYCLO[6.2.1.0(1,6)]",1001252-30-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a93acfc-8787-4b63-9a50-55137ee324fd/documents/84bc78a2-5f05-4c67-be35-b80d09dc8a76_bbe9ee5c-42a6-40cb-857d-00fb2e7ff31b.html,,oral,LD50,">=5,000 mg/kg bw",no adverse effect observed, "MIXTURE OF 2-(2,2,7,7-TETRAMETHYLTRICYCLO[6.2.1.0((1,6)]UNDEC-5-EN-5-YL)PROPAN-1-OL AND 2-(2,2,7,7-TETRAMETHYLTRICYCLO[6.2.1.0(1,6)]",1001252-30-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a93acfc-8787-4b63-9a50-55137ee324fd/documents/84bc78a2-5f05-4c67-be35-b80d09dc8a76_bbe9ee5c-42a6-40cb-857d-00fb2e7ff31b.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "MIXTURE OF 2-(2,2,7,7-TETRAMETHYLTRICYCLO[6.2.1.0((1,6)]UNDEC-5-EN-5-YL)PROPAN-1-OL AND 2-(2,2,7,7-TETRAMETHYLTRICYCLO[6.2.1.0(1,6)]",1001252-30-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a93acfc-8787-4b63-9a50-55137ee324fd/documents/84bc78a2-5f05-4c67-be35-b80d09dc8a76_bbe9ee5c-42a6-40cb-857d-00fb2e7ff31b.html,,inhalation,LC50,> 1.14 mg/L,adverse effect observed, MOLYBDATE DE TETRAKIS(TRIDODECYLAMMONIUM),88020-55-7,"NOAEL = 50 mg/kg bw/day Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Study conducted in compliance with the EPA (40 CFR parts 160 and 792) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/427de62e-b6eb-4ee7-8651-d97a68bfea20/documents/414c00a9-c030-4d98-8b01-0ff93967dd42_29817af7-d164-4e1c-afd7-e08b42ffa058.html,,,,,, MOLYBDATE DE TETRAKIS(TRIDODECYLAMMONIUM),88020-55-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/427de62e-b6eb-4ee7-8651-d97a68bfea20/documents/414c00a9-c030-4d98-8b01-0ff93967dd42_29817af7-d164-4e1c-afd7-e08b42ffa058.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Molybdenum,7439-98-7,"NOAEL for systemic toxicity, oral, from a sub-chronic study with sodium molybdate dihydrate in rats (Hoffman, 2011): 17 mg Mo/kg bw/day. Unbounded NOAEC for systemic toxicity, inhalation, from a sub-chronic study with molybdenum trioxide in rats and mice (NTP, 1997): 66.7 mg Mo/m³. Important: both values expressed based on element Mo (for read-across purposes), not on the respective test substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5dba5e7b-a814-4f97-851c-87864fe47ac7/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_81ab0e2f-09c9-41e5-9617-65f9805f4e7c.html,,,,,, Molybdenum,7439-98-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5dba5e7b-a814-4f97-851c-87864fe47ac7/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_81ab0e2f-09c9-41e5-9617-65f9805f4e7c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat Molybdenum,7439-98-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5dba5e7b-a814-4f97-851c-87864fe47ac7/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_81ab0e2f-09c9-41e5-9617-65f9805f4e7c.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,66.7 mg/m3,,other:rats and mice Molybdenum,7439-98-7," To avoid unnecessary (animal) testing, a comprehensive grouping and read-across concept has been developed amongst several molybdenum containing substances. Acute oral, inhalation and dermal toxicity studies are available for several but not all substances in the category. The following LD50s are therefore either based on test data for the substance in this dossier, or based on read-across within the category: For molybdenum (metal): LD50 oral: > 2000 mg/kg  (based on study with this substance) LD50 inhalation, 4h: > 5 g/m³ (estimated, based on category read-across) LD50 dermal: > 2000 mg/kg (estimated, based on category read-across) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5dba5e7b-a814-4f97-851c-87864fe47ac7/documents/IUC5-7360dc12-8fb8-44e3-80ee-0bdd9f021fb6_81ab0e2f-09c9-41e5-9617-65f9805f4e7c.html,,,,,, Molybdenum dioxide,18868-43-4,"NOAEL for systemic toxicity, oral, from a sub-chronic study with sodium molybdate dihydrate in rats (Hoffman, 2011): 17 mg Mo/kg bw/day. Unbounded NOAEC for systemic toxicity, inhalation, from a sub-chronic study with molybdenum trioxide in rats and mice (NTP, 1997): 66.7 mg Mo/m³. Important: both values expressed based on element Mo (for read-across purposes), not on the respective test substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43d00194-2d6e-4184-85f2-0bfb57103ba2/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_96747647-7bb7-4f49-b4e5-f69cd39bd5aa.html,,,,,, Molybdenum dioxide,18868-43-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43d00194-2d6e-4184-85f2-0bfb57103ba2/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_96747647-7bb7-4f49-b4e5-f69cd39bd5aa.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat Molybdenum dioxide,18868-43-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43d00194-2d6e-4184-85f2-0bfb57103ba2/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_96747647-7bb7-4f49-b4e5-f69cd39bd5aa.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,66.7 mg/m3,,other:rats and mice Molybdenum dioxide,18868-43-4," To avoid unnecessary (animal) testing, a comprehensive grouping and read-across concept has been developed amongst several molybdenum containing substances. Acute oral, inhalation and dermal toxicity studies are available for several but not all substances in the category. The following LD50s are therefore either based on test data for the substance in this dossier, or based on read-across within the category: For molybdenum dioxide: LD50 oral: > 2000 mg/kg  (based on study with this substance) LD50 inhalation, 4h: > 5.1 g/m³ (based on study with this substance) LD50 dermal: > 2000 mg/kg (estimated, based on category read-across) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43d00194-2d6e-4184-85f2-0bfb57103ba2/documents/IUC5-1ca3fdb6-dc56-4ffa-8f67-ac0ab43d2c7e_96747647-7bb7-4f49-b4e5-f69cd39bd5aa.html,,,,,, Molybdenum disilicide,12136-78-6, A 28-day repeated dose toxicity study by oral route is available for molybdenum disilicide. No adverse effects were observed up to the highest tested dose. The NOAEL is > 1000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fae066e4-2a39-496f-87e3-de5c973fae18/documents/ebe303b7-2d3a-4497-8a85-fea1718ac0ee_0733e28c-203b-4969-8123-80eca8a00a37.html,,,,,, Molybdenum disilicide,12136-78-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fae066e4-2a39-496f-87e3-de5c973fae18/documents/ebe303b7-2d3a-4497-8a85-fea1718ac0ee_0733e28c-203b-4969-8123-80eca8a00a37.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Molybdenum disilicide,12136-78-6," In an acute oral toxicity study (OECD 401) young adult Crl:CD (SD) rats (5 animals per sex and dose) were orally exposed to the source substance Sodium molybdate in corn oil at concentrations of 3200, 5000 and 6400 mg/kg bw. Mortality occurred within the different dose groups. The oral LD50 for both sexes was considered to be 4233 mg/kg body weight. This value equals 3136 mg/kg bw of the target substance Molybdenum disilicide. In an acute inhalation toxicity study equivalent to OECD 403, groups of young male and female Sprague-Dawley rats (5 per sex) were exposed via the inhalation route to the source substance Sodium molybdate (99.7% purity) for 4 hours to the whole body at a mean concentration of 1.93 mg/L. No mortality or distinct clinical signs were observed after exposure to Sodium molybdate. The LC50 for both sexes was considered to be greater than 1.93 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fae066e4-2a39-496f-87e3-de5c973fae18/documents/76facb0f-b2fe-446e-a3da-1701fadb1cc7_0733e28c-203b-4969-8123-80eca8a00a37.html,,,,,, Molybdenum disilicide,12136-78-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fae066e4-2a39-496f-87e3-de5c973fae18/documents/76facb0f-b2fe-446e-a3da-1701fadb1cc7_0733e28c-203b-4969-8123-80eca8a00a37.html,,oral,LD50,"3,136 mg/kg bw",adverse effect observed, Molybdenum nickel tetraoxide,14177-55-0,"oral: LD50 (rat, female) > 300 - < 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d550c362-406b-4f99-a602-af3c9c158d5e/documents/IUC5-99594e05-85ea-4bd5-8c4c-0bf8a4fb969e_bc4f803e-f43f-4056-902f-48907f0b0745.html,,,,,, Molybdenum sulfide,12612-50-9,"NOAEL for systemic toxicity, oral, from a sub-chronic study with sodium molybdate dihydrate in rats (Hoffman, 2011): 17 mg Mo/kg bw/day. Unbounded NOAEC for systemic toxicity, inhalation, from a sub-chronic study with molybdenum trioxide in rats and mice (NTP, 1997): 66.7 mg Mo/m³. Important: both values expressed based on element Mo (for read-across purposes), not on the respective test substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f85b5d39-1769-4fdd-856e-a2db1abc33ff/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_23a633ba-b949-47bf-83dc-309cb746cae3.html,,,,,, Molybdenum sulfide,12612-50-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f85b5d39-1769-4fdd-856e-a2db1abc33ff/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_23a633ba-b949-47bf-83dc-309cb746cae3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat Molybdenum sulfide,12612-50-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f85b5d39-1769-4fdd-856e-a2db1abc33ff/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_23a633ba-b949-47bf-83dc-309cb746cae3.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,66.7 mg/m3,,other:rats and mice Molybdenum sulfide,12612-50-9," To avoid unnecessary (animal) testing, a comprehensive grouping and read-across concept has been developed amongst several molybdenum containing substances. Acute oral, inhalation and dermal toxicity studies are available for several but not all substances in the category. The following LD50s are therefore either based on test data for the substance in this dossier, or based on read-across within the category: For molybdenum disulfide: LD50 oral: > 2000 mg/kg  (based on study with this substance) LD50 inhalation, 4h: > 2.8 g/m³ (based on study with this substance) LD50 dermal: > 2000 mg/kg (based on study with this substance) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f85b5d39-1769-4fdd-856e-a2db1abc33ff/documents/IUC5-835b8929-a854-4a42-8140-2dfc12ca081e_23a633ba-b949-47bf-83dc-309cb746cae3.html,,,,,, "Molybdenum sulfide (MoS2), roasted",86089-09-0,"NOAEL for systemic toxicity, oral, from a sub-chronic study with sodium molybdate dihydrate in rats (Hoffman, 2011): 17 mg Mo/kg bw/day. Unbounded NOAEC for systemic toxicity, inhalation, from a sub-chronic study with molybdenum trioxide in rats and mice (NTP, 1997): 66.7 mg Mo/m³. Important: both values expressed based on element Mo (for read-across purposes), not on the respective test substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0723339-bb86-4b06-8b63-8a6e72dec117/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_9d66b1b7-92a8-498b-bfea-49a7d24c12fd.html,,,,,, "Molybdenum sulfide (MoS2), roasted",86089-09-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0723339-bb86-4b06-8b63-8a6e72dec117/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_9d66b1b7-92a8-498b-bfea-49a7d24c12fd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat "Molybdenum sulfide (MoS2), roasted",86089-09-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b0723339-bb86-4b06-8b63-8a6e72dec117/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_9d66b1b7-92a8-498b-bfea-49a7d24c12fd.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,66.7 mg/m3,,other:rats and mice "Molybdenum sulfide (MoS2), roasted",86089-09-0," To avoid unnecessary (animal) testing, a comprehensive grouping and read-across concept has been developed amongst several molybdenum containing substances. Acute oral, inhalation and dermal toxicity studies are available for several but not all substances in the category. The following LD50s are therefore either based on test data for the substance in this dossier, or based on read-across within the category: For molybdenum sulfide (MoS2), roasted: LD50 oral: > 5000 mg/kg  (based on study with this substance) LD50 inhalation, 4h: > 3.92 g/m³ (based on study with this substance) LD50 dermal: > 2000 mg/kg (based on study with this substance) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b0723339-bb86-4b06-8b63-8a6e72dec117/documents/IUC5-2e2dd0af-dceb-4f2b-9d60-5948458955d8_9d66b1b7-92a8-498b-bfea-49a7d24c12fd.html,,,,,, Molybdenum zinc tetraoxide,13767-32-3, Acute oral toxicity: Key study: OECD 423. GLP study. The LD50 of the test item is greater than 2000 mg/kg body weight after single oral administration to Wistar rats. The LD50 cut off value was determined to be 2500 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/842b4f97-b479-4b8c-a7ff-de9fdd7064ed/documents/90be3d59-ebed-4870-94a5-820ab119f09e_0b7b5e8e-4a09-4931-bd9d-fe56030e37f4.html,,,,,, Molybdenum zinc tetraoxide,13767-32-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/842b4f97-b479-4b8c-a7ff-de9fdd7064ed/documents/90be3d59-ebed-4870-94a5-820ab119f09e_0b7b5e8e-4a09-4931-bd9d-fe56030e37f4.html,,oral,discriminating dose,"2,500 mg/kg bw",adverse effect observed, "Molybdenum, bis(dibutylcarbamodithioato)di-μ-oxodioxodi-, sulfurized",68412-26-0," In a combined repeat dose toxicity study (OECD 422), the oral administration of the test item to (parental) Sprague Dawley (Crl:CD(SD)) rats at dose levels of 100, 330 or 1000 mg/kg/day for five weeks to males and for two weeks before pairing, throughout gestation and up to Day 14 of lactation in females was well-tolerated in the adult animals with no treatment related adverse effect observed. The no-observed-adverse-effect-level (NOAEL) for systemic toxicity was considered to be 1000 mg/kg/day, the highest dose tested. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fa5da8d-2e80-49f0-b14b-bbd3962f49b2/documents/fc47a3a9-b87c-4409-b514-f59b5a66e20a_4d33ecfb-8b26-4192-af0e-7c9aa08359cc.html,,,,,, "Molybdenum, bis(dibutylcarbamodithioato)di-μ-oxodioxodi-, sulfurized",68412-26-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fa5da8d-2e80-49f0-b14b-bbd3962f49b2/documents/fc47a3a9-b87c-4409-b514-f59b5a66e20a_4d33ecfb-8b26-4192-af0e-7c9aa08359cc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Molybdenum, bis(dibutylcarbamodithioato)di-μ-oxodioxodi-, sulfurized",68412-26-0," Under the conditions of the study, the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System: Unclassified). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fa5da8d-2e80-49f0-b14b-bbd3962f49b2/documents/b914c4bc-18e0-4b0f-a77e-f8b73edd073d_4d33ecfb-8b26-4192-af0e-7c9aa08359cc.html,,,,,, "Molybdenum, bis(dibutylcarbamodithioato)di-μ-oxodioxodi-, sulfurized",68412-26-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fa5da8d-2e80-49f0-b14b-bbd3962f49b2/documents/b914c4bc-18e0-4b0f-a77e-f8b73edd073d_4d33ecfb-8b26-4192-af0e-7c9aa08359cc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Molybdenum, N,N-bis(C11-14-branched and linear alkyl)carbamodithioate oxo thioxo complexes",906665-74-5," In a study performed to the standardized guidelines OECD 422, under GLP conditions, the No-observed-adverse-effect-level (NOAEL) of the test item for systemic toxicity effects was considered to be 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6442025c-c3e5-4f64-bf32-74327d895613/documents/a42cada5-76c9-4b04-b0be-6803c467721b_a16c93fe-f9ca-420d-99c6-d2dca3e66006.html,,,,,, "Molybdenum, N,N-bis(C11-14-branched and linear alkyl)carbamodithioate oxo thioxo complexes",906665-74-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6442025c-c3e5-4f64-bf32-74327d895613/documents/a42cada5-76c9-4b04-b0be-6803c467721b_a16c93fe-f9ca-420d-99c6-d2dca3e66006.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Molybdenum, N,N-bis(C11-14-branched and linear alkyl)carbamodithioate oxo thioxo complexes",906665-74-5," Acute Toxicity: Oral Key study: The single-dose oral toxicity of the test substance was evaluated in Sprague-Dawley rats in a study performed to the standardised guideline OECD 401 under GLP conditions. A limit test was performed in which one group of five male and five female rats received a single oral administration of the test article at a dose level of 2000 mg/kg body weight. Following dosing, the limit test rats were observed daily and weighed weekly. A gross necropsy examination was performed on all limit test animals at the time of scheduled euthanasia (day 14).   No mortality occurred during the limit test. Clinical abnormalities noted during the study were observed in one female and consisted on incidences of decreased activity, soft stools, urine/faecal staining and rales. Body weight gain was normal for all animals during the test period. No gross internal findings were observed at necropsy on study day 14.   Under the conditions of this test, the acute oral LD50 was estimated to be greater than 2000 mg/kg in the rat (Springborn Laboratories, Inc., 1996.   Acute Toxicity: Dermal and Inhalation The acute dermal and inhalation toxicity studies have been waived. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6442025c-c3e5-4f64-bf32-74327d895613/documents/7c8a8d44-c0f7-4ca0-8f35-5c63a30e493e_a16c93fe-f9ca-420d-99c6-d2dca3e66006.html,,,,,, "Molybdenum, N,N-bis(C11-14-branched and linear alkyl)carbamodithioate oxo thioxo complexes",906665-74-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6442025c-c3e5-4f64-bf32-74327d895613/documents/7c8a8d44-c0f7-4ca0-8f35-5c63a30e493e_a16c93fe-f9ca-420d-99c6-d2dca3e66006.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Monalazone disodium,61477-95-0,Oral LD50 (female; rat) 2500 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/890b6aea-1105-4bad-968e-5f6a794b3065/documents/c74c35cb-0d4e-4570-be45-12723724a4ed_fad36849-860b-41cb-929b-5775c7632f48.html,,,,,, Monalazone disodium,61477-95-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/890b6aea-1105-4bad-968e-5f6a794b3065/documents/c74c35cb-0d4e-4570-be45-12723724a4ed_fad36849-860b-41cb-929b-5775c7632f48.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Monoethanolamine oleate,2272-11-9,"The NOAEL of 1000 mg/kg bw/day, based on the read-across with monoethanolamine, will be taken forward as a point of departure for DNEL derivation for monoethanolamine oleate. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9a473cd-690b-4cf6-b5f7-59eda892cc7e/documents/IUC5-cf606535-855d-44b1-8633-9fedba2b0f48_31ca37e4-6a38-4a6a-9bb8-f59255ca4df0.html,,,,,, Monoethanolamine oleate,2272-11-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9a473cd-690b-4cf6-b5f7-59eda892cc7e/documents/IUC5-cf606535-855d-44b1-8633-9fedba2b0f48_31ca37e4-6a38-4a6a-9bb8-f59255ca4df0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Monoethanolamine oleate,2272-11-9,"The calculated oral and dermal LD50 for monoethanolamine oleate are > 2000 mg/kg bw, based on the read-across with monoethanolamine. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9a473cd-690b-4cf6-b5f7-59eda892cc7e/documents/IUC5-ed010574-23d3-4229-a4d2-975bb0579ef3_31ca37e4-6a38-4a6a-9bb8-f59255ca4df0.html,,,,,, Monoethanolamine oleate,2272-11-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9a473cd-690b-4cf6-b5f7-59eda892cc7e/documents/IUC5-ed010574-23d3-4229-a4d2-975bb0579ef3_31ca37e4-6a38-4a6a-9bb8-f59255ca4df0.html,,oral,LD50,"2,000 mg/kg bw",, Monoethanolamine oleate,2272-11-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9a473cd-690b-4cf6-b5f7-59eda892cc7e/documents/IUC5-ed010574-23d3-4229-a4d2-975bb0579ef3_31ca37e4-6a38-4a6a-9bb8-f59255ca4df0.html,,dermal,LD50,"2,000 mg/kg bw",, Monophosphothiamine,532-40-1," Oral, male rats: LD50 = 3710 mg/kg bw (RA CAS 67-03-8) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/497c46ec-6f60-4f26-a65e-2330b5942097/documents/1582e777-e84f-4854-bc3a-f0025e47c175_a949de08-f0ce-4f98-8845-1d55d879da70.html,,,,,, Monophosphothiamine,532-40-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/497c46ec-6f60-4f26-a65e-2330b5942097/documents/1582e777-e84f-4854-bc3a-f0025e47c175_a949de08-f0ce-4f98-8845-1d55d879da70.html,,oral,LD50,"3,710 mg/kg bw",adverse effect observed, "Monosodium aqua-[5-[[2,4-dihydroxy-5-[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]-2-naphthalensulfonate], iron complex",126851-40-9,"oralrat (OECD 409)  NOAEL (m/f): 55 mg/kg bw/day  (BASF AG, 1988)dermalActually, there is no information available.inhalationActually, there is no information available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e364e256-629d-4657-81c9-fe34e71693fb/documents/IUC5-83fc3829-c593-47ed-8229-798f01cfd91b_201c14fe-499f-4955-a160-19012779f29d.html,,,,,, "Monosodium aqua-[5-[[2,4-dihydroxy-5-[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]-2-naphthalensulfonate], iron complex",126851-40-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e364e256-629d-4657-81c9-fe34e71693fb/documents/IUC5-83fc3829-c593-47ed-8229-798f01cfd91b_201c14fe-499f-4955-a160-19012779f29d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,55 mg/kg bw/day,,rat "Monosodium aqua-[5-[[2,4-dihydroxy-5-[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]-2-naphthalensulfonate], iron complex",126851-40-9," Acute Oral toxicity Rat: LD50 (m/f) > 2200 mg/kg bw (EU B.1; BASF AG, 1993) Rat:LD50 (m/f) > 5000 mg/kg bw (OECD 401; BASF AG, 1984)              Acute Inhalation toxicity Rat:LC50 (m/f) > 5200 mg/m3, 4h (OECD 403; BASF AG, 1988) Acute Dermal toxicity Actually, there is no information available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e364e256-629d-4657-81c9-fe34e71693fb/documents/IUC5-8d9b259b-c01f-4fbe-a13d-f5577abb42df_201c14fe-499f-4955-a160-19012779f29d.html,,,,,, "Monosodium aqua-[5-[[2,4-dihydroxy-5-[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]-2-naphthalensulfonate], iron complex",126851-40-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e364e256-629d-4657-81c9-fe34e71693fb/documents/IUC5-8d9b259b-c01f-4fbe-a13d-f5577abb42df_201c14fe-499f-4955-a160-19012779f29d.html,,oral,LD50,"2,200 mg/kg bw",no adverse effect observed, "Monosodium aqua-[5-[[2,4-dihydroxy-5-[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]-2-naphthalensulfonate], iron complex",126851-40-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e364e256-629d-4657-81c9-fe34e71693fb/documents/IUC5-8d9b259b-c01f-4fbe-a13d-f5577abb42df_201c14fe-499f-4955-a160-19012779f29d.html,,inhalation,LC50,"5,200 mg/m3",no adverse effect observed, 4-((Triethoxysilyl)methyl)morpholine,21743-27-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c53ce5f-d691-476a-89d0-caff14ef6a2f/documents/IUC5-262b588f-add9-4a03-9323-6b049b54f5f6_f616abc2-c963-47ba-a3a4-92adc332a531.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Morpholine, 4-C12-14-alkyl derivs.",1402434-48-3,"In a 90-day oral NOAEL for local effects < 30 mg/kg bw/day based on minimal to slight forestomach lesions observed in one female animal at 30 mg dose level. Systemic NOAEL is 30 mg/kg bw/day, based on lower body weight (males only), slight changes in absolute and relative neutrophil counts indicative of inflammation, and slight increased kidney weights and liver weight at 100 mg/kg bw/day, that are more pronounced at 300 mg/kg bw in females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d918cbf4-bd4a-45e6-94b7-8775f20cb6e4/documents/IUC5-8fac7f1c-c3ff-4a4f-b8e8-220ca0711255_c77cb094-4531-4351-9fb2-a750745e4e77.html,,,,,, "Morpholine, 4-C12-14-alkyl derivs.",1402434-48-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d918cbf4-bd4a-45e6-94b7-8775f20cb6e4/documents/IUC5-8fac7f1c-c3ff-4a4f-b8e8-220ca0711255_c77cb094-4531-4351-9fb2-a750745e4e77.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "Morpholine, 4-C12-14-alkyl derivs.",1402434-48-3,The available data suggests that C12-C14 alkylmorpholine has a moderate potential for acute oral toxicity (LD50 cut-off = 500 mg/kg bw) and a low potential for acute dermal toxicity (LD50 > 2000 mg/kg bw). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d918cbf4-bd4a-45e6-94b7-8775f20cb6e4/documents/IUC5-b3927c18-c5c3-4a02-94df-74ed387d50bd_c77cb094-4531-4351-9fb2-a750745e4e77.html,,,,,, "Morpholine, 4-C12-14-alkyl derivs.",1402434-48-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d918cbf4-bd4a-45e6-94b7-8775f20cb6e4/documents/IUC5-b3927c18-c5c3-4a02-94df-74ed387d50bd_c77cb094-4531-4351-9fb2-a750745e4e77.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Morpholinium toluene-4-sulphonate,13732-62-2,"Oral: Several repeated dose studies are available for morpholine, toluene-4-sulphonic acid and its salts. These available data have been evaluated in a Weight of Evidence approach. For further information, see section ""Additional information"". ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fdc4708-90b1-4335-b11d-5fe741adbf4a/documents/IUC5-4eb2b644-b704-4b6c-9447-76e0b23c76a8_470e7ba1-fa7b-4149-a0c1-3bbf68d9d3f1.html,,,,,, Morpholinium toluene-4-sulphonate,13732-62-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fdc4708-90b1-4335-b11d-5fe741adbf4a/documents/IUC5-4eb2b644-b704-4b6c-9447-76e0b23c76a8_470e7ba1-fa7b-4149-a0c1-3bbf68d9d3f1.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,500 mg/kg bw/day,,rat Morpholinium toluene-4-sulphonate,13732-62-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3fdc4708-90b1-4335-b11d-5fe741adbf4a/documents/IUC5-4eb2b644-b704-4b6c-9447-76e0b23c76a8_470e7ba1-fa7b-4149-a0c1-3bbf68d9d3f1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,ca.140 mg/kg bw/day,,mouse Morpholinium toluene-4-sulphonate,13732-62-2,"Oral: LD50: 7500 mg/kg bw (rat) Inhalation: Effect level (slight irritation of the respiratory tract): ca. 5.84 mg/L (rat, 8h) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fdc4708-90b1-4335-b11d-5fe741adbf4a/documents/IUC5-d784dff1-8210-42da-a0d7-0c04dc94ad0f_470e7ba1-fa7b-4149-a0c1-3bbf68d9d3f1.html,,,,,, Morpholinium toluene-4-sulphonate,13732-62-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fdc4708-90b1-4335-b11d-5fe741adbf4a/documents/IUC5-d784dff1-8210-42da-a0d7-0c04dc94ad0f_470e7ba1-fa7b-4149-a0c1-3bbf68d9d3f1.html,,oral,LD50,"7,500 mg/kg bw",adverse effect observed, Morpholinium toluene-4-sulphonate,13732-62-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3fdc4708-90b1-4335-b11d-5fe741adbf4a/documents/IUC5-d784dff1-8210-42da-a0d7-0c04dc94ad0f_470e7ba1-fa7b-4149-a0c1-3bbf68d9d3f1.html,,inhalation,,5.84 mg/L,no adverse effect observed, 4-[2-[2-[(2-hydroxyphenyl)methylene]hydrazinyl]-2-oxoethyl]-4-methylmorpholinium chloride,1254469-57-2,"Based on the results of a combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test of TINOCAT ES 96000 in rats by oral gavage, the changes noted for females at the highest dose level were considered to be treatment related but not adverse. Therefore, a NOAEL of 800 mg/kg bw/day was derived. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/022aeb4b-d2d9-49ba-ab4e-6b3d27f6e8db/documents/IUC5-f9a93f87-4449-46cd-96cf-482fbc15f751_9bfc4e4f-4167-4c91-82de-bdc11679795a.html,,,,,, 4-[2-[2-[(2-hydroxyphenyl)methylene]hydrazinyl]-2-oxoethyl]-4-methylmorpholinium chloride,1254469-57-2,"LD50 oral ca. 2000 mg/kg bw (BASF SE, 2011)LD50 dermal > 2000 mg/kg bw (Bioassay, 2013) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/022aeb4b-d2d9-49ba-ab4e-6b3d27f6e8db/documents/IUC5-98c93f66-64c5-40bf-8c1d-fa99ed026939_9bfc4e4f-4167-4c91-82de-bdc11679795a.html,,,,,, 4-[2-[2-[(2-hydroxyphenyl)methylene]hydrazinyl]-2-oxoethyl]-4-methylmorpholinium chloride,1254469-57-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/022aeb4b-d2d9-49ba-ab4e-6b3d27f6e8db/documents/IUC5-98c93f66-64c5-40bf-8c1d-fa99ed026939_9bfc4e4f-4167-4c91-82de-bdc11679795a.html,,oral,LD50,"2,000 mg/kg bw",, MoVNbTe mixed oxide,146569-48-4,"To evaluate repeated dose toxicity a GLP compliant OECD TG 412 was performed to investigate a possible effect for repeated dose toxicity via inhalation. The objective of this study was to determine the toxic potential of the test item, when administered for 6 hours/day, 5 days per week, for 4 consecutive weeks by flow-past nose-only inhalation route to Sprague Dawley rats. A total of 60 (30 males + 30 females) healthy young Sprague Dawley rats were distributed to four groups viz., control (G1), low dose (G2), mid dose (G3), high dose (G4) and two recovery groups [(G1R (Air only) and G4R (high dose)].  Each main and recovery group comprised of 10 animals (5 males and 5 females). Animals allocated to groups G2, G3 and G4/G4R were exposed to test item for 6 hours per day, 5 days per week, for 4 consecutive weeks at a nominal target concentration of 500, 1500 and 5000 mg/m3. Animals of the control group (G1/G1R) received air only inhalation for 6 hours/day for 4 consecutive weeks. The inhalation exposure of test item/air was achieved by a flow-past, nose-only dynamic inhalation exposure system. Addionally to the usual set of endpoints, at the end of treatment and recovery periods all animals were fasted overnight (water was availablead libitum), and the next day, blood, urine, and Broncho alveolar lavage fluid (BALF) samples were collected and analysed. Subsequently, the animals were sacrificed and subjected to gross pathological examination, and the organs were collected, weighed, and preserved. The tissues/organs in vehicle control and high dose group animals including recovery animals were subjected to histopathological examinations. No clinical signs of toxicity or mortality/morbidity were noted in any of the treated and recovery group animals. During exposure, black faeces was observed, from 3rd hour to end of exposure period and during post exposure 30-40 minutes and 1 hour in G4/G4R group animals from days 2 to 5, days 9 to 12, days 16 to 19, days 23 to 26 and on days 6, 13, 20, 27. The coloration of faeces is because of the colouration of test item, hence considered as non-adverse.  No treatment-related changes in body weight, percent change in body weight with respect to day 1, feed consumption,or ophthalmology were noted.No adverse effects were observed in the neurological/functional examination tests.No adverse effects were observed in haematology, clinical chemistry, coagulationor urinalysis parameters. During BALF analysis, few significant changes were noted in the differential counts and WBC counts which are considered to be secondary to the accumulation of test item particles in the lungs, however, they are considered non adverse in the absence of any adverse microscopic changes in the lungs. No toxicologically significant changes were observed infasting body weight,organ weight and its ratios. During gross pathology, blackish discoloration of lungs in mid (Male: 3/5, Female: 4/5), high (Male: 5/5, Female: 5/5) and high dose recovery (Male: 5/5, Female: 5/5) group of rats in both sexes and blackish contents in caecum of high dose (Male: 5/5, Female: 5/5) rats was observed. This blackish discoloration was attributed to physical appearance (solid black)of inhaled test item which might have imparted discoloration to the tissues. Microscopically, test item-related changes were observed in lungs. In lungs, minimal to mild, multifocal, variably sized, pigmented (blackish brown) granular material was observed throughout the parenchyma of lung at mid, high and high dose recovery groups of rats. This pigment was distributed both in alveolar and bronchiolar spaces with no accompanying inflammation or tissue destruction to the lung parenchyma. This pigment was suggestive of inhaled test item particles as the physical appearance of test item was also black coloured powder. In the absence of cellular changes to lung parenchyma, were presence of pigment in lungs could be considered as non-adverse effect up to the dose level of 5000 mg/m³.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e673bb2f-6dbe-4510-8903-36789b7d5394/documents/37580bcb-7bb6-42d8-9016-442a67bfd34a_76b7ec77-f809-4b13-b0ca-1135da6637ee.html,,,,,, MoVNbTe mixed oxide,146569-48-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e673bb2f-6dbe-4510-8903-36789b7d5394/documents/37580bcb-7bb6-42d8-9016-442a67bfd34a_76b7ec77-f809-4b13-b0ca-1135da6637ee.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"5,040 mg/m3",,rat MoVNbTe mixed oxide,146569-48-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e673bb2f-6dbe-4510-8903-36789b7d5394/documents/37580bcb-7bb6-42d8-9016-442a67bfd34a_76b7ec77-f809-4b13-b0ca-1135da6637ee.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"5,040 mg/m3",no adverse effect observed, MoVNbTe mixed oxide,146569-48-4,"The test material was tested for acute oral and inhalation toxicity in GLP compliant studies according to respective OECD test guidelines (OECD TG 423 & 403). The test item was applied either via gavage (vehicle: 0.5% w/v CMC) or as an aerosol to Sprague Dawley rats.  Regarding acute oral toxicity,  step wise approach was performed applying single doses of 300 mg/kg bw in the first step and 2,000 mg/kg bw in the second step. No clinical signs, mortalities, changes in bodyweight and percent change in body weight or pathological changes were observed in both steps. Hence, a LD50 > 2,000 mg/kg is suggested.  In the context of acute inhalation toxicity, a limit test with 5.04 mg/L exposed through flow-past nose-only dynamic inhalation equipement for 4 h was performed. The aerosol obtained MMAD of 2.86 - 3.18 µm with a GSD of 2.55-2.58. After exposure, no treatment related clinical signs of toxicity and mortalities were observed. Slight decrease in body weight was noted on Day 2 due to exposure. All animals showed increase in body weight on day 4, 8 and 15. No treatment related gross pathological findings were observedat the mean maximum achievable concentration of 5.04mg/L of air. In conclusion, a LC50 > 5.04 mg/L was obtained. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e673bb2f-6dbe-4510-8903-36789b7d5394/documents/89de5fc4-90ea-47eb-8a2c-fba87537260a_76b7ec77-f809-4b13-b0ca-1135da6637ee.html,,,,,, MoVNbTe mixed oxide,146569-48-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e673bb2f-6dbe-4510-8903-36789b7d5394/documents/89de5fc4-90ea-47eb-8a2c-fba87537260a_76b7ec77-f809-4b13-b0ca-1135da6637ee.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, MoVNbTe mixed oxide,146569-48-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e673bb2f-6dbe-4510-8903-36789b7d5394/documents/89de5fc4-90ea-47eb-8a2c-fba87537260a_76b7ec77-f809-4b13-b0ca-1135da6637ee.html,,inhalation,LC50,> 5.04 mg/L,no adverse effect observed, m-phenylene di(acetate),108-58-7,A valid Combined Repeated Dose Toxicity Study and Reproductive/Developmental Toxicity Screening Study according to OECD TG 422 in the Han Wistar rat by oral gavage administration is available. The no-observed adverse-effect level (NOAEL) of Resorcinol diacetate for systemic toxicity was considered to be 330 mg/kg/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34edfbd6-1993-419d-9387-fdca83b9fe2e/documents/ae85d342-2c42-4801-a605-b78f5a1bc112_e4899522-1e1c-4ea0-9f84-358660622064.html,,,,,, m-phenylene di(acetate),108-58-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34edfbd6-1993-419d-9387-fdca83b9fe2e/documents/ae85d342-2c42-4801-a605-b78f5a1bc112_e4899522-1e1c-4ea0-9f84-358660622064.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,330 mg/kg bw/day,,rat m-phenylene di(acetate),108-58-7,"Valid studies for acute oral and dermal toxicity are available. Oral toxicity: Six groups of 10 male young adult rats (160-180 g) were dosed at 1000, 3100, 4000, 5000, 6300 or 8200 mg/kg bw by gavage. A LD50 = 4010 mg/kg bw was found. Up to 2000 mg/kg bw no adverse effects were observed. Clinical signs at 3100 mg/kg bw and above included tremor and bloody eyes. Dermal toxicity: Resorcinol diacetate was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). LD50 > 2000 mg/kg bw (discriminating dose). No mortality occurred. Inhalation toxicity: No study available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34edfbd6-1993-419d-9387-fdca83b9fe2e/documents/ef05c5b7-c828-4488-ac33-956102b60241_e4899522-1e1c-4ea0-9f84-358660622064.html,,,,,, m-phenylene di(acetate),108-58-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34edfbd6-1993-419d-9387-fdca83b9fe2e/documents/ef05c5b7-c828-4488-ac33-956102b60241_e4899522-1e1c-4ea0-9f84-358660622064.html,,oral,LD50,"4,010 mg/kg bw",no adverse effect observed, m-phenylene di(acetate),108-58-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34edfbd6-1993-419d-9387-fdca83b9fe2e/documents/ef05c5b7-c828-4488-ac33-956102b60241_e4899522-1e1c-4ea0-9f84-358660622064.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, m-phenylenebis(methylamine),1477-55-0,"The significant toxic changes detected after repeated oral administration of the test material to rats were stomach membrane disorders. The changes in the digestive system are considered to be induced by the corrosive nature of the substance. The systemic LOAEL is 600 mg/kg bw/day.The toxic changes detected after repeated inhalation administration of the test material to rats were minimal to mild bronchial epitelial degeneration, minimal bronchial squamous metaplasia and minimal to mild subacute inflamation in the lungs. The local changes in the inhalatory system are considered to be induced by the corrosive nature of the substance. The systemic NOAEC is assumed too be at 30 mg/m^3. The local NOAEC is determined at 5 mg/m^3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/52978b27-74fa-446b-acb8-0daea32ae555/documents/IUC5-95cd43da-008d-42a4-879e-aa9e90f08e52_17f16620-e03a-46fc-8c02-348bbc108c69.html,,,,,, m-phenylenebis(methylamine),1477-55-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/52978b27-74fa-446b-acb8-0daea32ae555/documents/IUC5-95cd43da-008d-42a4-879e-aa9e90f08e52_17f16620-e03a-46fc-8c02-348bbc108c69.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat m-phenylenebis(methylamine),1477-55-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/52978b27-74fa-446b-acb8-0daea32ae555/documents/IUC5-95cd43da-008d-42a4-879e-aa9e90f08e52_17f16620-e03a-46fc-8c02-348bbc108c69.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat m-phenylenebis(methylamine),1477-55-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/52978b27-74fa-446b-acb8-0daea32ae555/documents/IUC5-95cd43da-008d-42a4-879e-aa9e90f08e52_17f16620-e03a-46fc-8c02-348bbc108c69.html,Repeated dose toxicity – local effects,inhalation,NOAEC,5 mg/m3,adverse effect observed,rat m-phenylenebis(methylamine),1477-55-0,Oral LD50 930 mg/kg in the rat (worst case result from a weight of evidence) (according to OECD TG 401)Dermal LD50 > 3100 mg/kg in the rabbit (similar to OECD TG 402)Inhalation LC50 (4h) 1.34 mg/L in the rat (according to OECD TG 403) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52978b27-74fa-446b-acb8-0daea32ae555/documents/IUC5-810d6a5a-eb65-4030-87bc-7b9ecdd98f79_17f16620-e03a-46fc-8c02-348bbc108c69.html,,,,,, m-phenylenebis(methylamine),1477-55-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52978b27-74fa-446b-acb8-0daea32ae555/documents/IUC5-810d6a5a-eb65-4030-87bc-7b9ecdd98f79_17f16620-e03a-46fc-8c02-348bbc108c69.html,,oral,LD50,930 mg/kg bw,adverse effect observed, m-phenylenebis(methylamine),1477-55-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52978b27-74fa-446b-acb8-0daea32ae555/documents/IUC5-810d6a5a-eb65-4030-87bc-7b9ecdd98f79_17f16620-e03a-46fc-8c02-348bbc108c69.html,,dermal,LD50,"3,100 mg/kg bw",adverse effect observed, m-phenylenebis(methylamine),1477-55-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52978b27-74fa-446b-acb8-0daea32ae555/documents/IUC5-810d6a5a-eb65-4030-87bc-7b9ecdd98f79_17f16620-e03a-46fc-8c02-348bbc108c69.html,,inhalation,LC50,"1,340 mg/m3",adverse effect observed, m-toluic acid,99-04-7," Oral: In a combined repeated dose/ reproductive and developmental toxicity test according to OECD guideline 422, rats were exposed to 30, 100, 300 and 1000 mg/kg bw/day m-toluic acid for 41 to 45 days, resulting in an NOAEL of 1000 mg/kg bw/day for male animals due to an absence of adverse effects and an NOAEL for females of 100 mg/kg bw/day based on increased relative and absolute liver weight and the periportal hepatocyte vacuolar swelling. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d2f3a7e-c2ac-49a9-b9db-027176ae8efc/documents/6f0ec9e1-c755-4e64-8ac3-499980a5d017_5d50963b-3d81-4148-912e-4d3039703d86.html,,,,,, m-toluic acid,99-04-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d2f3a7e-c2ac-49a9-b9db-027176ae8efc/documents/6f0ec9e1-c755-4e64-8ac3-499980a5d017_5d50963b-3d81-4148-912e-4d3039703d86.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat m-toluic acid,99-04-7," LD50 (oral, male and females rats) > 2000 mg/kg bw, no clinical signs of systemic toxicity were observed throughout the 14 -day observation period. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d2f3a7e-c2ac-49a9-b9db-027176ae8efc/documents/9ae49496-8afb-4492-82bf-442ab764d211_5d50963b-3d81-4148-912e-4d3039703d86.html,,,,,, m-toluidine,108-44-1," In a study according to OECD TG 422 and GLP conditions male and female SD (Crj:CD) rats received 0, 30, 100, or 300 mg/kg bw/day m-toluidine by gavage (MHLW 1995). Hematological and biochemical analysis was conducted only for males. Compound related clinical signs were low locomotor activity and pale skin at 300 mg/kg bw. At the lowest dose of 30 mg/kg bw marginal deposit pigmentation and extramedullary hematopoiesis in the spleen were observed suggesting that a slight hemolysis occurred.. Therefore, the dose of 30 mg/kg bw/day should be considered to be adverse effect level because of suggestive evidence of hemolytic anemia. LOAEL for repeat dose toxicity was 30 mg/kg bw/day (UNEP 2003). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3377cb32-ff47-4e9e-acd7-c1c282e8d97c/documents/IUC5-9da49a87-5e09-4acb-b683-d035b5c21917_a5fd1987-9f20-4d6f-98e3-da54f60b519b.html,,,,,, m-toluidine,108-44-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3377cb32-ff47-4e9e-acd7-c1c282e8d97c/documents/IUC5-9da49a87-5e09-4acb-b683-d035b5c21917_a5fd1987-9f20-4d6f-98e3-da54f60b519b.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,30 mg/kg bw/day,,rat m-toluidine,108-44-1," Oral application of 1350 -700 mg/kg bw m-toluidine dissolved in corn oil, resulted in a LD50 value of 922 mg/kg bw (DuPont De Nemours 1980). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3377cb32-ff47-4e9e-acd7-c1c282e8d97c/documents/IUC5-ec6f09b0-c9b1-4848-9568-c2d3db5e9b31_a5fd1987-9f20-4d6f-98e3-da54f60b519b.html,,,,,, m-toluidine,108-44-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3377cb32-ff47-4e9e-acd7-c1c282e8d97c/documents/IUC5-ec6f09b0-c9b1-4848-9568-c2d3db5e9b31_a5fd1987-9f20-4d6f-98e3-da54f60b519b.html,,oral,LD50,922 mg/kg bw,adverse effect observed, m-toluidine,108-44-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3377cb32-ff47-4e9e-acd7-c1c282e8d97c/documents/IUC5-ec6f09b0-c9b1-4848-9568-c2d3db5e9b31_a5fd1987-9f20-4d6f-98e3-da54f60b519b.html,,dermal,LD50,"1,015 mg/kg bw",adverse effect observed, m-tolyl isocyanate,621-29-4,no data ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37f41012-baf5-4b5f-896a-4d38ba62df3f/documents/IUC5-03b4e1c2-ab4b-43ce-a1a4-144381560b82_4344a07f-66e6-4b27-9bb7-979bf7484537.html,,,,,, m-tolyl isocyanate,621-29-4,"Acute Tox. Oral: K2, Oral, OECD TG 425, Rats; LD50 = 2926 mg/kg bw for rat (male+female), Loeser (1980) S2 Oral, , LD50 = 3191 mg/kg bw (male rats), Loeser (1979)   Acute Tox. Inhalation: K1, OECD TG 403, Rat 4-hr inhalation aerosol, LC50 = 33 mg/m³ air and for female rats a LC50 = 30 mg/m³ air (analytical vapour concentration), Pauluhn (1988) S2, Inhalation Hazard Test, Thyssen (1980) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The materials/methods and results are described in detail and are sufficient for evaluation. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The materials/methods and results are described in detail and are sufficient for evaluation. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37f41012-baf5-4b5f-896a-4d38ba62df3f/documents/IUC5-d911d505-5f51-4478-954c-ff7c28e5de53_4344a07f-66e6-4b27-9bb7-979bf7484537.html,,,,,, m-tolyl isocyanate,621-29-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37f41012-baf5-4b5f-896a-4d38ba62df3f/documents/IUC5-d911d505-5f51-4478-954c-ff7c28e5de53_4344a07f-66e6-4b27-9bb7-979bf7484537.html,,oral,LD50,"2,926 mg/kg bw",adverse effect observed, m-tolyl isocyanate,621-29-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37f41012-baf5-4b5f-896a-4d38ba62df3f/documents/IUC5-d911d505-5f51-4478-954c-ff7c28e5de53_4344a07f-66e6-4b27-9bb7-979bf7484537.html,,inhalation,LC50,30 mg/m3,adverse effect observed, Mucorpepsin,148465-73-0,"In a DRF study, the administration of mucorpepsin to CD rats for 4 weeks at dietary levels of 10000 ppm was associated with only minor evidence of toxicity in females. The level of 10000 ppm was estimated to be suitable for the high dietary concentration on a 13-week toxicity study in this species. After dietary administration of mucropepsin to CD rats for 13 weeks, chronic myocarditis in the high dose male rats were observed at a higher incidence than in the controls, but otherwise there was no evidence of systemic toxicity. After dietary administration of rennilase to CD rats for 13 weeks, chronic myocarditis was observed at a higher incidence than in the controls in males that received 10000 ppm (610.8 mg enzyme concentrate dry matter/kg/day). This change is a normal spontaneous finding in ageing rats but it is also known to be exacerbated by a number of materials. The reason for the absence of a similar effect in females is unknown. As such, this finding is considered to be of little toxicological significance. In conclusion, the administration of rennilase to CD rats at a level of 10000 ppm (610.8 mg enzyme concentrated dry matter/kg/day for males and 695 mg enzyme concentrate dry matter/kg/day for females) was associated with only minor evidence of toxicity. The no-effect level on this study was 2000 ppm (124 mg enzyme concentrate dry matter/kg/day for males and 138.3 mg enzyme concentrate dry matter/kg/day for females). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Toxicological data has been generated within the enzyme producing industry during the last 40 years. Substantial documentation on the safety of the production strains has been generated, and the enzyme test materials are thoroughly characterized. High quality studies for all relevant endpoints for in vivo studies as well as in vitro studies show that industrial enzymes from well-known and well characterized production strains have very similar safety profiles across the catalytic activities. Read-across can therefore be applied for the majority of toxicological endpoints. The database can therefore be considered of high quality. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1b2f99b-4f00-41f4-a56f-810aaf189af6/documents/3ac02e77-4cde-4ebf-95de-4969437464c4_0bdab72e-78e4-4fd5-8ba8-31f13c0ead8f.html,,,,,, Mucorpepsin,148465-73-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1b2f99b-4f00-41f4-a56f-810aaf189af6/documents/3ac02e77-4cde-4ebf-95de-4969437464c4_0bdab72e-78e4-4fd5-8ba8-31f13c0ead8f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,124 mg/kg bw/day,,rat Mucorpepsin,148465-73-0,"Rennilase SP 252 did not cause any effects on Wistar rats administered a single dose of 14.2 g enzyme concentrate dry matter/kg bw followed by a 14 -day observation period. Therefore, it was considered as relatively harmless (according to Guidebook: Toxic Substance Control Act, edited by George Dominquez and published by CRC Press, Inc. in 1977). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1b2f99b-4f00-41f4-a56f-810aaf189af6/documents/784ba0cb-2df4-4ff0-87ee-f092286e240f_0bdab72e-78e4-4fd5-8ba8-31f13c0ead8f.html,,,,,, Mullite,1302-93-8,"he systemic, nasal, and pulmonary responses to inhaled ACM that were observed in this study were similar to, or less than, that observed in rats similarly exposed to other inorganic particulates such as titanium dioxide (10 mg/m3 TiO2) or amorphous silica (50 mg/m3), respectively. It is significant that the ACM- induced pulmonary effects observed in this study were unlike those observed following exposure to a fibrogenic particulate such as crystalline silica (3 mg/m3) which results in significantly greater, chronic, neutrophilic inflammation and progressive pulmonary fibrotic lesions at exposure concentrations 3 to 20-fold lower than those used in this study. These data suggest that ACM has little or no inherent toxicity except that associated with inhalation of high concentrations of nontoxic, but irritating, inorganic particulates. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89707cb4-5a6f-48eb-b19f-81af4e0f0a78/documents/IUC5-923237ba-5677-49bf-91bf-8e49a616ad9f_055b5ea2-f5a6-459b-b6f7-13435b7e0dca.html,,,,,, Mullite,1302-93-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89707cb4-5a6f-48eb-b19f-81af4e0f0a78/documents/IUC5-923237ba-5677-49bf-91bf-8e49a616ad9f_055b5ea2-f5a6-459b-b6f7-13435b7e0dca.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,60 mg/m3,,rat Mullite,1302-93-8,"The concentration of 2.19 mg/m³ in the air represents the technically achievable limit. Since at this concentration only overload effects to the tissue of the respiratory tract, but no toxic effects were observed, this value cannot considered to be the LC50 for the classification of the substance. The substance fulfils the criteria of inert dust and can be classified as “not dangerous” with respect to acute toxicity. This is underpinned by results of the studies described in chapter 5.6 and 5.10.The substance has a low acute toxicity, which is not relevant for the practical use. The data are not leading to a classification according to DPD/DSD or CLP-system ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89707cb4-5a6f-48eb-b19f-81af4e0f0a78/documents/IUC5-ef8e794c-51cb-404d-88b3-56490992cd09_055b5ea2-f5a6-459b-b6f7-13435b7e0dca.html,,,,,, Mullite,1302-93-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89707cb4-5a6f-48eb-b19f-81af4e0f0a78/documents/IUC5-ef8e794c-51cb-404d-88b3-56490992cd09_055b5ea2-f5a6-459b-b6f7-13435b7e0dca.html,,oral,LD50,"2,000 mg/kg bw",, Mullite,1302-93-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89707cb4-5a6f-48eb-b19f-81af4e0f0a78/documents/IUC5-ef8e794c-51cb-404d-88b3-56490992cd09_055b5ea2-f5a6-459b-b6f7-13435b7e0dca.html,,dermal,LD50,"2,000 mg/kg bw",, Mullite,1302-93-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89707cb4-5a6f-48eb-b19f-81af4e0f0a78/documents/IUC5-ef8e794c-51cb-404d-88b3-56490992cd09_055b5ea2-f5a6-459b-b6f7-13435b7e0dca.html,,inhalation,discriminating conc.,6 mg/m3,, "Myo-Inositol, hexakis(dihydrogen phosphate), dodecasodium salt",17211-15-3," Acute Toxicity Oral (read across), rat (Fischer 344/DuCrj) m / f: LD50: 1030 mg/kg bw (male); 1200 mg/kg bw (female) Acute Toxicity Oral (read across), mice (ICL-ICR) m / f: LD50: 1030 mg/kg bw (male); 2750 mg/kg bw (female) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1716890e-4cf9-4651-bd58-d716a5b593dc/documents/9576e32d-45fd-414f-9917-cadfde6f4d48_e60b0e98-c3f5-4da1-ab2f-f80fd4165fe2.html,,,,,, "Myo-Inositol, hexakis(dihydrogen phosphate), dodecasodium salt",17211-15-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1716890e-4cf9-4651-bd58-d716a5b593dc/documents/9576e32d-45fd-414f-9917-cadfde6f4d48_e60b0e98-c3f5-4da1-ab2f-f80fd4165fe2.html,,oral,LD50,"1,030 mg/kg bw",adverse effect observed, "N-(1,1,3,3-tetramethylbutyl)acrylamide",4223-03-4,"The is an OECD422 Oral gavage dosing study available which is GLP compliant and Klimisch 1 rated for validity.  This study is suitable as the basis for deriving DNELS based on the NOAEL values determined.  The low vapour pressure and low dermal penetration support the use of the oral NOAEL for the calculation of DNELs for oral, dermal and inhalation exposure ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/524395b4-b9ae-476a-91ab-1c09fb5b1c09/documents/IUC5-07a242f7-eba1-4776-909a-499e6c3ac433_18bee0f1-7e8b-4e16-be36-e7dbf9efb00f.html,,,,,, "N-(1,1,3,3-tetramethylbutyl)acrylamide",4223-03-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/524395b4-b9ae-476a-91ab-1c09fb5b1c09/documents/IUC5-07a242f7-eba1-4776-909a-499e6c3ac433_18bee0f1-7e8b-4e16-be36-e7dbf9efb00f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,155 mg/kg bw/day,,rat "N-(1,1,3,3-tetramethylbutyl)acrylamide",4223-03-4,"There are there studies available, two in mice and one in rats that give an indication of the acute oral LD50, this is sufficient for classification and labeling.  Extremely low dermal penetration testing indicates that acute dermal toxicity would be low and certainly lower than oral toxicity.  Inhalation data is not available but not required due to low potential for exposure via inhalation in industrial use of the substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/524395b4-b9ae-476a-91ab-1c09fb5b1c09/documents/IUC5-85c57937-6e82-41e8-afa5-0d8f3a8dd4dc_18bee0f1-7e8b-4e16-be36-e7dbf9efb00f.html,,,,,, "N-(1,1,3,3-tetramethylbutyl)acrylamide",4223-03-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/524395b4-b9ae-476a-91ab-1c09fb5b1c09/documents/IUC5-85c57937-6e82-41e8-afa5-0d8f3a8dd4dc_18bee0f1-7e8b-4e16-be36-e7dbf9efb00f.html,,oral,LD50,"1,210 mg/kg bw",adverse effect observed, "N-(1,1-dimethyl-3-oxobutyl)acrylamide",2873-97-4," Hepatocellular hypertrophy in the liver was recorded in males at 100 and 300 mg/kg and females at 300 mg/kg up to slight severity. At 300 mg/kg, this was accompanied by increased liver weight (up to 23% relative to body weight for both sexes). The morphological change in the liver occurred in the absence of any indicator of hepatocellular toxicity and was therefore not considered adverse. However, the accompanying higher liver weights recorded at 300 mg/kg in both sexes were considered adverse considering the magnitude of increase (i.e. approximately 20% higher than controls). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8284a912-7895-4c7f-aecc-03b80e495bad/documents/IUC5-61cb7fe0-eb2a-4f26-82a2-e35c6a342f2a_8e4a4cd1-be36-426f-a7eb-50b615c46ce8.html,,,,,, "N-(1,1-dimethyl-3-oxobutyl)acrylamide",2873-97-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8284a912-7895-4c7f-aecc-03b80e495bad/documents/IUC5-61cb7fe0-eb2a-4f26-82a2-e35c6a342f2a_8e4a4cd1-be36-426f-a7eb-50b615c46ce8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "N-(1,1-dimethyl-3-oxobutyl)acrylamide",2873-97-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8284a912-7895-4c7f-aecc-03b80e495bad/documents/IUC5-9477f548-f3b4-4947-bacd-4d38dfd29c23_8e4a4cd1-be36-426f-a7eb-50b615c46ce8.html,,oral,LD50,"1,520 mg/kg bw",adverse effect observed, "N-(1,1-dimethyl-3-oxobutyl)acrylamide",2873-97-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8284a912-7895-4c7f-aecc-03b80e495bad/documents/IUC5-9477f548-f3b4-4947-bacd-4d38dfd29c23_8e4a4cd1-be36-426f-a7eb-50b615c46ce8.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N-(1,1-dimethylethyl)bis(2-benzothiazolesulfen)amide",3741-80-8,"For the oral route, two well-documented K2 studies (of which one is the range-finder for the other) are available. The NOAEL for males and females in this study was considered to be 15000 ppm after 90 days of feeding, which corresponds to actual received doses of ca. 1093 mg/kg bw d for males and 1334 mg/kg bw d for female animals.For the inhalatory and dermal route of administration no studies on TBSI are available. Nevertheless, for each of both exposure routes the adverse effects of read across substance TBBS have been assessed. The inhalation toxicity of TBBS was examined in a subacute inhalation study (Monsanto Co. 1981). Due to the limitations of the test protocol that was used the assessment of systemic effects is questionnable and, as a consequence, only the local inhalation effects are considered to be reliable. Based on the fact that signs of nasal irritation observed at clinical examination were reversible, only short in duration and could not be correlated to histopathological effects, no toxicological significance was attached to this finding and thus, no relevant local effects were observed up to 0.084 mg/l. A 21-day dermal toxicity study of TBBS showed no systemic effect up to the highest dose level (2000 mg/kg bw/d), which can be regarded as the systemic NOAEL. Local effects consisted of acanthosis, hyperkeratosis and dermal inflammatory cell infiltrate in the treated skin of rabbits from the 2000 mg/kg bw/d group, but not in the lower dosed animals. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/107bb769-ae76-45bc-853b-d114112a15fe/documents/c67eab32-f58a-4793-ba8c-a2349a0b7e62_f970dcc1-66b4-4336-a8f7-512ab1896b45.html,,,,,, "N-(1,1-dimethylethyl)bis(2-benzothiazolesulfen)amide",3741-80-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/107bb769-ae76-45bc-853b-d114112a15fe/documents/c67eab32-f58a-4793-ba8c-a2349a0b7e62_f970dcc1-66b4-4336-a8f7-512ab1896b45.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,093 mg/kg bw/day",,rat "N-(1,1-dimethylethyl)bis(2-benzothiazolesulfen)amide",3741-80-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/107bb769-ae76-45bc-853b-d114112a15fe/documents/c67eab32-f58a-4793-ba8c-a2349a0b7e62_f970dcc1-66b4-4336-a8f7-512ab1896b45.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rabbit "N-(1,1-dimethylethyl)bis(2-benzothiazolesulfen)amide",3741-80-8,"One acute oral toxicity study (K1) and one acute dermal toxicity study (K1) are available. Both studies are carried out under GLP conditions and according to internationally accepted study protocols.Under the conditions of the acute oral toxicity test, the acute oral LD50 of the test substance was determined to be greater than 5000 mg/kg bw in the rat. Under the conditions of the acute dermal toxicity test, the acute dermal LD50 of the test substance was determined to be greater than 2000 mg/kg bw in the rabbit.The test substance therefore is considered practically nontoxic. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/107bb769-ae76-45bc-853b-d114112a15fe/documents/a828cc17-e3d2-4ca7-8613-ff597234bac3_f970dcc1-66b4-4336-a8f7-512ab1896b45.html,,,,,, "N-(1,3-dimethylbutylidene)-5-[(1,3-dimethylbutylidene)amino]-1,3,3-trimethylcyclohexanemethylamine",66230-21-5, The oral LD50: 2000 mg/kg body weight (OECD 425) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72288322-c7ff-4245-bf94-710c94854c80/documents/cfc30996-fa9e-486d-88fb-3004eee213a4_de932207-06e3-488d-8189-5177e07a34ab.html,,,,,, "N-(1,3-dimethylbutylidene)-5-[(1,3-dimethylbutylidene)amino]-1,3,3-trimethylcyclohexanemethylamine",66230-21-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72288322-c7ff-4245-bf94-710c94854c80/documents/cfc30996-fa9e-486d-88fb-3004eee213a4_de932207-06e3-488d-8189-5177e07a34ab.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N-(1,4-dimethylpentyl)-N'-phenylbenzene-1,4-diamine",3081-01-4," There are no subchronic or chronic repeated dose study data and reproduction toxicity data available for 7PPD. A read across approach with data from 6PPD is conducted. 7PPD and 6PPD have similarities in the chemical structure and physico-chemicals properties. These similarities include vapour pressures, low water solubility, a lipophilic character and hydrolytically instability. However, at room temperature the physical states are different. The similarities are also seen in mammalian cell toxicity. The skin and eye irritation potential for 7PPD and 6PPD is low. The in vitro and in vivo genotoxic potential is low. The acute oral toxicity for 7PPD is low and for 6PPD is moderate. For both substances a low dermal acute toxicity was indicated. Clinical signs and death occurred after oral and dermal application, indicating systemic availability for both application routes and substances. There is only a limited subacute feeding study available for 7PPD; whereas several repeated dose toxicity studies are available for 6PPD. For the 7PPD a NOAEL of 1500 ppm (males: 101.2 mg/kg bw, females: 134.3 mg/kg bw) was suggested, which based on slight effects on body weights and liver weights at 3000 ppm (males: 186.9 mg/kg bw/d, females: 199.6 mg/kg bw/d). For the 6PPD data from several repeated dose toxicity studies are available. Oral administration of 6PPD to male and female rats revealed adverse effects on the liver and changes in hematology. For the 6PPD a NOAEL of 20 mg/kg bw/day was oberseved within the subchronic and chronic studies.This was used as starting point for DNEL calculation . ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c2ccb8a-14a1-4fe1-9a7c-811ad4de4822/documents/IUC5-b41b9d04-4d58-412b-b64f-699b1aa5d393_a83db6d4-800b-4eab-bb8c-ccfe1dae7005.html,,,,,, "N-(1,4-dimethylpentyl)-N'-phenylbenzene-1,4-diamine",3081-01-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c2ccb8a-14a1-4fe1-9a7c-811ad4de4822/documents/IUC5-b41b9d04-4d58-412b-b64f-699b1aa5d393_a83db6d4-800b-4eab-bb8c-ccfe1dae7005.html,Chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "N-(1,4-dimethylpentyl)-N'-phenylbenzene-1,4-diamine",3081-01-4," The acute dermal and oral toxicity of the test substance 7PPD is very low, indicated by oral LD50 values greater than 2000 mg/kg. The acute oral LD50 value in rats is = 2100 mg/kg bw (Monsanto Co. 1973, 1967a) and the dermal LD50 value in rabbits is greater than 5010 mg/kg bw (Monsanto Co. 1973, Monsanto Co. 1967a). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c2ccb8a-14a1-4fe1-9a7c-811ad4de4822/documents/IUC5-20cee3a3-2880-40d0-9449-f71f582ae7ae_a83db6d4-800b-4eab-bb8c-ccfe1dae7005.html,,,,,, "N-(1,4-dimethylpentyl)-N'-phenylbenzene-1,4-diamine",3081-01-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c2ccb8a-14a1-4fe1-9a7c-811ad4de4822/documents/IUC5-20cee3a3-2880-40d0-9449-f71f582ae7ae_a83db6d4-800b-4eab-bb8c-ccfe1dae7005.html,,oral,LD50,"2,100 mg/kg bw",adverse effect observed, "N-(1,4-dimethylpentyl)-N'-phenylbenzene-1,4-diamine",3081-01-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c2ccb8a-14a1-4fe1-9a7c-811ad4de4822/documents/IUC5-20cee3a3-2880-40d0-9449-f71f582ae7ae_a83db6d4-800b-4eab-bb8c-ccfe1dae7005.html,,dermal,LD50,"5,010 mg/kg bw",adverse effect observed, N-(2-(4-amino-N-ethyl-m-toluidino)ethyl)methanesulphonamide sesquisulphate,25646-71-3," Combined 28-Day Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (according to OECD 422), oral, rat: systemic NOAEL >= 50 mg/kg bw/day (highest dose tested) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf3927df-9f5f-4c84-a548-65329d69361e/documents/874bd512-98bc-44e8-9e30-a33e2723d644_cf72d68d-e972-4eef-a4e1-a08f7b1370c4.html,,,,,, N-(2-(4-amino-N-ethyl-m-toluidino)ethyl)methanesulphonamide sesquisulphate,25646-71-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf3927df-9f5f-4c84-a548-65329d69361e/documents/874bd512-98bc-44e8-9e30-a33e2723d644_cf72d68d-e972-4eef-a4e1-a08f7b1370c4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat N-(2-(4-amino-N-ethyl-m-toluidino)ethyl)methanesulphonamide sesquisulphate,25646-71-3," Acute oral toxicity (equivalent to OECD 401), rat: 75 mg/kg bw > LD50 < 300 mg/kg bw Acute dermal toxicity (according to OECD 402, GLP compliant), rat: > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf3927df-9f5f-4c84-a548-65329d69361e/documents/b1b931de-f6ac-4410-aacd-84c98e4861d0_cf72d68d-e972-4eef-a4e1-a08f7b1370c4.html,,,,,, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(2-methoxyphenyl)azo]-3-oxobutyramide",82199-12-0,"C.I Pigment Yellow 194  administered orally by gavage to Wistar rats when for a 90 day and the reversibilityof any effects was assessed during a 28-days recovery period.  The results of the study indicated that the oral administration of test item C.I. Pigment Yellow 194 for 90 consecutive days in Wistar rats at dose levels of 111, 333 and 1000 mg/kg/day doses did not cause any toxicological effect on general health, body weights, food consumption, haematology, clinical chemistry, coagulation parameters, terminal fasting body weight, organ weights and histopathology in both sexes. Yellow colour faecal matter was observed at all the tested doses in both sexes during the treatment period. Grossly, yellow colored intestinal contents noted in 333 mg/kg/day and 1000 mg/kg/day rats (both sex). Yellow colour of faecal matter and intestinal contents was attributed to the physical appearance of the test item. As there were no treatment-related adverse effects observed up to the highest dose, the No Observed Adverse Effect Level (NOAEL) for systemic toxicity of the test item C.I. Pigment Yellow 194 is considered to be 1000 mg/kg/day under the test conditions and doses employed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/563ed677-9ed7-4bd9-aa2e-c673669f7318/documents/354a1699-d4f3-4ffb-95a9-7e87d4ad95ef_73bd8a00-7c53-415e-827e-025e70311f0b.html,,,,,, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(2-methoxyphenyl)azo]-3-oxobutyramide",82199-12-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/563ed677-9ed7-4bd9-aa2e-c673669f7318/documents/354a1699-d4f3-4ffb-95a9-7e87d4ad95ef_73bd8a00-7c53-415e-827e-025e70311f0b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(2-methoxyphenyl)azo]-3-oxobutyramide",82199-12-0,"Acute oral toxicity Female rats were subjected to test acute oral toxicity according to the acute class method (OECD TG 423, Limit test). The test substance was administered by gavage at the limit dose of 2000 mg/kg bw to two groups of 3 animals. All treated animals expressed mild clinical signs of toxicity following the treatment. A slightly ruffled fur was observed in some animals which lasted until day 3, at the most. Moreover all animals showed a hunched posture for a few hours after the treatment. No animal died within the observation period, resulting in a LD50 > 2000mg/kg bw.   Acute inhalation toxicity (Pigment Orange 36) Acute inhalation toxicity of the test item, Pigment Orange 36, has been investigated in male and female Wistar rats. Mean dust exposure concentration was 1274 mg test substance per cubic metre (i.e. maximum technically feasible concentration; exposure ranged from 521 to 2511 mg/ cubic metre). The rats were exposed for 4 hours, nose only. All animals survived the 14 day observation period. No macroscopic visible changes were observed at necropsy at the end of the observation period, resulting in a LC50 value of > 1274 mg/m³ for the inhalation of dust. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/563ed677-9ed7-4bd9-aa2e-c673669f7318/documents/97466faf-64d4-4215-9ff4-993c6dc5c2c3_73bd8a00-7c53-415e-827e-025e70311f0b.html,,,,,, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(2-methoxyphenyl)azo]-3-oxobutyramide",82199-12-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/563ed677-9ed7-4bd9-aa2e-c673669f7318/documents/97466faf-64d4-4215-9ff4-993c6dc5c2c3_73bd8a00-7c53-415e-827e-025e70311f0b.html,,oral,LD0,"> 2,000 mg/kg bw",adverse effect observed, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(2-methoxyphenyl)azo]-3-oxobutyramide",82199-12-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/563ed677-9ed7-4bd9-aa2e-c673669f7318/documents/97466faf-64d4-4215-9ff4-993c6dc5c2c3_73bd8a00-7c53-415e-827e-025e70311f0b.html,,inhalation,LC0,"1,274 mg/m3",no adverse effect observed, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(4-nitrophenyl)azo]-3-oxobutyramide",52846-56-7," The results of a subchronic study indicate that the oral administration of test item for 90 consecutive days in Wistar rats at dose levels of 111, 333 and 1000 mg/kg/day doses did not cause any toxicological effect on general health, body weights, food consumption, haematology, clinical chemistry, coagulation parameters, terminal fasting body weight, organ weights and histopathology in both sexes. As there were no treatment-related adverse effects observed up to the highest dose, the No Observed Adverse Effect Level (NOAEL) for systemic toxicity of the test item C.I. Pigment Yellow 194 is considered to be 1000 mg/kg/day under the test conditions and doses employed. Based on the observed results, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item was found to be 0.03 mg/L when exposed for 6 hours/day, 5 days/week, for 4 weeks by flow-past nose-only inhalation route to Sprague Dawley rats. The nominal dose of 0.03 mg/L (6 hrs/day, 5 days/week) is the actual exposure concentration in males and females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47aeb84e-c56d-4ac5-8ad4-1b6b7bcc2a40/documents/44ff4dd1-5fe7-4166-93e5-5935847a79e6_234d7d60-35a7-4747-a66c-a5968c503eea.html,,,,,, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(4-nitrophenyl)azo]-3-oxobutyramide",52846-56-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47aeb84e-c56d-4ac5-8ad4-1b6b7bcc2a40/documents/44ff4dd1-5fe7-4166-93e5-5935847a79e6_234d7d60-35a7-4747-a66c-a5968c503eea.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(4-nitrophenyl)azo]-3-oxobutyramide",52846-56-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47aeb84e-c56d-4ac5-8ad4-1b6b7bcc2a40/documents/44ff4dd1-5fe7-4166-93e5-5935847a79e6_234d7d60-35a7-4747-a66c-a5968c503eea.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(4-nitrophenyl)azo]-3-oxobutyramide",52846-56-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47aeb84e-c56d-4ac5-8ad4-1b6b7bcc2a40/documents/44ff4dd1-5fe7-4166-93e5-5935847a79e6_234d7d60-35a7-4747-a66c-a5968c503eea.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(4-nitrophenyl)azo]-3-oxobutyramide",52846-56-7," Single application of 15000 mg/kg bw of the test substance did not cause lethality in female Wistar rats during the 14 day observation period, resulting in a LD50 > 15000 mg/kg bw. Exposure of male and female Wistar rats to 1274 mg/m³ test item (i.e. maximum technically feasible concentration) for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 1274 mg/m³. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47aeb84e-c56d-4ac5-8ad4-1b6b7bcc2a40/documents/896563d5-8e65-4094-a423-1146f5fc2162_234d7d60-35a7-4747-a66c-a5968c503eea.html,,,,,, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(4-nitrophenyl)azo]-3-oxobutyramide",52846-56-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47aeb84e-c56d-4ac5-8ad4-1b6b7bcc2a40/documents/896563d5-8e65-4094-a423-1146f5fc2162_234d7d60-35a7-4747-a66c-a5968c503eea.html,,oral,LD0,"15,000 mg/kg bw",no adverse effect observed, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-2-[(4-nitrophenyl)azo]-3-oxobutyramide",52846-56-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47aeb84e-c56d-4ac5-8ad4-1b6b7bcc2a40/documents/896563d5-8e65-4094-a423-1146f5fc2162_234d7d60-35a7-4747-a66c-a5968c503eea.html,,inhalation,LC0,"1,274 mg/m3",no adverse effect observed, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2,5-dimethoxy-4-[(methylamino)sulphonyl]phenyl]azo]naphthalene-2-carboxamide",12225-08-0," RA from PR208 This study is a valid investigation of the toxicological effects resulting from repeated oral-gavage administration of the test item to rats (according to OECD 422, GLP compliant). The test item was administered in vehicle (corn oil) at dosages of 100, 300, and 1000 mg/kg body weight/day, animals in control groups received the vehicle only. Test item was administered to male rats for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum (i.e. 54 days). No test item related effects of toxicological relevance were found at any dose level tested. Thus, the NOAEL for general toxicity in males and females and for reproduction/developmental toxicity is considered to be >=1000 mg/kg body weight. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0cbd1069-32f1-4eb9-a027-557a9b985def/documents/658b388c-b145-4021-a303-3dc61e71f047_2044ead3-3454-43f9-99d3-7e653327d271.html,,,,,, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2,5-dimethoxy-4-[(methylamino)sulphonyl]phenyl]azo]naphthalene-2-carboxamide",12225-08-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0cbd1069-32f1-4eb9-a027-557a9b985def/documents/658b388c-b145-4021-a303-3dc61e71f047_2044ead3-3454-43f9-99d3-7e653327d271.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2,5-dimethoxy-4-[(methylamino)sulphonyl]phenyl]azo]naphthalene-2-carboxamide",12225-08-0," RA from PR208 10 Female Wistar rats were exposed to 15000 mg test item/kg bw once by gavage. Animals were observed for a period of 14 days. No animal died within this time and clinical signs and body weight development were normal. Therefore the LD50 value is > 15000 mg/kg bw for female Wistar rats. RA from PBr25 Under the conditions of the present study, a single oral application of the test item to female rats at a dose of 2000 mg/kg body weight was associated with no sign of toxicity or mortality. The LD50 for female rats is > 2000 mg/kg body weight. Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity nor signs of irritation. The dermal LD50 was determined to be > 2000 mg/ kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0cbd1069-32f1-4eb9-a027-557a9b985def/documents/ddc03d7f-d0a9-4f00-ba26-52e813d2755f_2044ead3-3454-43f9-99d3-7e653327d271.html,,,,,, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",12225-06-8," PR176 Under the conditions of the present study, the repeated oral administration of test material to male and female Wistar rats at doses of 100, 300 and 1000 mg/kg body weight for 28 days was associated with no relevant signs of toxicity or mortality. Based on the data generated from this study, the NOAEL (No Observed Adverse Effect Level) of the teat material is considered to be 1000 mg/kg body weight/day (i.h. highest dose tested) for the 28-day repeated dose oral toxicity study in male and female rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74b8d102-6689-4cbd-99ad-500846a05b00/documents/2cf44498-a3b8-417f-9019-2f68ecf56406_dcc98f7c-ef94-4f69-87da-1e65d9bb8752.html,,,,,, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",12225-06-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74b8d102-6689-4cbd-99ad-500846a05b00/documents/2cf44498-a3b8-417f-9019-2f68ecf56406_dcc98f7c-ef94-4f69-87da-1e65d9bb8752.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",12225-06-8,"RA from PB25 Under the conditions of the present study, a single oral application of the test item to female rats at a dose of 2000 mg/kg body weight was associated with no sign of toxicity or mortality. The LD50 for female rats is  >2000 mg/kg body weight.   Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity nor signs of irritation. The dermal LD50 was determined to be > 2000 mg/ kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74b8d102-6689-4cbd-99ad-500846a05b00/documents/29aba0aa-0e0c-4056-9b79-78d1f6992183_dcc98f7c-ef94-4f69-87da-1e65d9bb8752.html,,,,,, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",12225-06-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74b8d102-6689-4cbd-99ad-500846a05b00/documents/29aba0aa-0e0c-4056-9b79-78d1f6992183_dcc98f7c-ef94-4f69-87da-1e65d9bb8752.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",12225-06-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74b8d102-6689-4cbd-99ad-500846a05b00/documents/29aba0aa-0e0c-4056-9b79-78d1f6992183_dcc98f7c-ef94-4f69-87da-1e65d9bb8752.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2-methoxy-5-methyl-4-[(methylamino)sulphonyl]phenyl]azo]naphthalene-2-carboxamide",51920-12-8," RA from PR176 Under the conditions of the present study, the repeated oral administration of test material to male and female Wistar rats at doses of 100, 300 and 1000 mg/kg body weight for 28 days was associated with no relevant signs of toxicity or mortality. Based on the data generated from this study, the NOAEL (No Observed Adverse Effect Level) of the teat material is considered to be 1000 mg/kg body weight/day (i.h. highest dose tested) for the 28-day repeated dose oral toxicity study in male and female rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb76a731-de7f-4572-a664-6cfd1a225f5c/documents/1abd4f43-e448-4057-96f6-994a8482f70d_8a4ab8a7-831f-4b2a-b57d-654935bc10dd.html,,,,,, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2-methoxy-5-methyl-4-[(methylamino)sulphonyl]phenyl]azo]naphthalene-2-carboxamide",51920-12-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb76a731-de7f-4572-a664-6cfd1a225f5c/documents/1abd4f43-e448-4057-96f6-994a8482f70d_8a4ab8a7-831f-4b2a-b57d-654935bc10dd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2-methoxy-5-methyl-4-[(methylamino)sulphonyl]phenyl]azo]naphthalene-2-carboxamide",51920-12-8," RA from PB25 Under the conditions of the present study, a single oral application of the test item  to female rats at a dose of 2000 mg/kg body weight was associated with no sign of toxicity or mortality. The LD50 for female rats is  >  2000 mg/kg body weight Under the conditions of the present study, single dermal application of the test item to rats at a dose of 2000 mg/kg body weight was associated with no mortality and neither signs of toxicity nor signs of irritation. The dermal LD50 was determined to be > 2000 mg/ kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb76a731-de7f-4572-a664-6cfd1a225f5c/documents/fdeafab8-e6ea-4ee1-985f-e5f4d5c2b703_8a4ab8a7-831f-4b2a-b57d-654935bc10dd.html,,,,,, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2-methoxy-5-methyl-4-[(methylamino)sulphonyl]phenyl]azo]naphthalene-2-carboxamide",51920-12-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb76a731-de7f-4572-a664-6cfd1a225f5c/documents/fdeafab8-e6ea-4ee1-985f-e5f4d5c2b703_8a4ab8a7-831f-4b2a-b57d-654935bc10dd.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-hydroxy-4-[[2-methoxy-5-methyl-4-[(methylamino)sulphonyl]phenyl]azo]naphthalene-2-carboxamide",51920-12-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb76a731-de7f-4572-a664-6cfd1a225f5c/documents/fdeafab8-e6ea-4ee1-985f-e5f4d5c2b703_8a4ab8a7-831f-4b2a-b57d-654935bc10dd.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxo-2-[[2-(trifluoromethyl)phenyl]azo]butyramide",68134-22-5," Based on the results of an OECD 407 subacute study, the no-observed-adverse-effect-level (NOAEL) was considered to be 1000 mg/kg body weight/day The results of the subchronic oral study indicated that the oral administration of test item for 90 consecutive days in Wistar rats at dose levels of 111, 333 and 1000 mg/kg/day doses did not cause any toxicological effect on general health, body weights, food consumption, haematology, clinical chemistry, coagulation parameters, terminal fasting body weight, organ weights and histopathology in both sexes. As there were no treatment-related adverse effects observed up to the highest dose, the No Observed Adverse Effect Level (NOAEL) for systemic toxicity of the test item C.I. Pigment Yellow 194 is considered to be 1000 mg/kg/day under the test conditions and doses employed. Based on the observed results of a 28 day inhalation study in rats, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item was found to be 0.03 mg/L when exposed for 6 hours/day, 5 days/week, for 4 weeks by flow-past nose-only inhalation route to Sprague Dawley rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5edc0ad5-0937-4077-84e6-5c494447320b/documents/83432822-69dd-43cc-8e5f-3f5dcdff3976_fcf217a1-0e5e-491d-889b-d823c1d0dcd7.html,,,,,, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxo-2-[[2-(trifluoromethyl)phenyl]azo]butyramide",68134-22-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5edc0ad5-0937-4077-84e6-5c494447320b/documents/83432822-69dd-43cc-8e5f-3f5dcdff3976_fcf217a1-0e5e-491d-889b-d823c1d0dcd7.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxo-2-[[2-(trifluoromethyl)phenyl]azo]butyramide",68134-22-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5edc0ad5-0937-4077-84e6-5c494447320b/documents/83432822-69dd-43cc-8e5f-3f5dcdff3976_fcf217a1-0e5e-491d-889b-d823c1d0dcd7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxo-2-[[2-(trifluoromethyl)phenyl]azo]butyramide",68134-22-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5edc0ad5-0937-4077-84e6-5c494447320b/documents/83432822-69dd-43cc-8e5f-3f5dcdff3976_fcf217a1-0e5e-491d-889b-d823c1d0dcd7.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxo-2-[[2-(trifluoromethyl)phenyl]azo]butyramide",68134-22-5," Single oral application of 15000 mg/kg bw of the test substance did not cause lethality in female Wistar rats during the 14 day observation period, resulting in a LD50 > 15000 mg/kg bw. Exposure of male and female Wistar rats to 1274 mg/m³ of a close structural analogue oof the test item (i.e. maximum technically feasible concentration) for 4 hours did not result in the death of the animals during a 14 day observation period, resulting in a LC50 value of > 1274 mg/m³. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5edc0ad5-0937-4077-84e6-5c494447320b/documents/d60b141b-45dc-407f-ba97-b9dee181dd7d_fcf217a1-0e5e-491d-889b-d823c1d0dcd7.html,,,,,, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxo-2-[[2-(trifluoromethyl)phenyl]azo]butyramide",68134-22-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5edc0ad5-0937-4077-84e6-5c494447320b/documents/d60b141b-45dc-407f-ba97-b9dee181dd7d_fcf217a1-0e5e-491d-889b-d823c1d0dcd7.html,,oral,LD0,">=15,000 mg/kg bw",no adverse effect observed, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxo-2-[[2-(trifluoromethyl)phenyl]azo]butyramide",68134-22-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5edc0ad5-0937-4077-84e6-5c494447320b/documents/d60b141b-45dc-407f-ba97-b9dee181dd7d_fcf217a1-0e5e-491d-889b-d823c1d0dcd7.html,,inhalation,LC50,"> 1,274 mg/m3",no adverse effect observed, "N-(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)-3-oxobutyramide",26576-46-5,"The highest oral dose tested (15000 mg/kg bw) in two separate studies caused no lethality, no clinical signs, no effects on body weight gain and no abnormal macroscopic findings when administered to male or female rats. Consequently the oral LD50 is above 15000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e481a89a-3fbd-4f2a-968c-875d3a24b9ba/documents/IUC5-3634fc86-004a-4ad2-a27a-e45186c35aa5_5658df0f-b7b1-473b-9357-8c3003ba39d9.html,,,,,, "N-(2-aminoethyl)-1,3-propanediamine",13531-52-7,"The substance is considered to be classified for acute oral and dermal toxicity as follows: acute toxicity: cat. 4, (H302, harmful if swallowed), cat. 2, (H310, fatal in contact with skin). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff3b0f85-3951-44de-a408-9db805af478f/documents/IUC5-0a778aea-0033-4c1c-ade7-106db53d9fee_7dbc5764-5be6-4826-90a9-42bfdd6dfb61.html,,,,,, "N-(2-aminoethyl)-1,3-propanediamine",13531-52-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff3b0f85-3951-44de-a408-9db805af478f/documents/IUC5-0a778aea-0033-4c1c-ade7-106db53d9fee_7dbc5764-5be6-4826-90a9-42bfdd6dfb61.html,,oral,LD50,654 mg/kg bw,adverse effect observed, "N-(2-aminoethyl)-1,3-propanediamine",13531-52-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff3b0f85-3951-44de-a408-9db805af478f/documents/IUC5-0a778aea-0033-4c1c-ade7-106db53d9fee_7dbc5764-5be6-4826-90a9-42bfdd6dfb61.html,,dermal,LD50,184 mg/kg bw,adverse effect observed, N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]ethylenediamine,35141-30-1," OECD 422 (including FOB), oral (gavage), rat: NOAEL =500 mg/kg bw/day (RA from N-(3-(trimethoxysilyl)propyl) ethylenediamine, CAS 1760-24-3)) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7d961dc-e66f-4a75-bd5c-cafaa57e53ba/documents/3178c000-2b7b-4b7f-b997-25aaedf549c0_665d71a0-2066-44d9-aa2d-ba327aeba208.html,,,,,, N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]ethylenediamine,35141-30-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7d961dc-e66f-4a75-bd5c-cafaa57e53ba/documents/3178c000-2b7b-4b7f-b997-25aaedf549c0_665d71a0-2066-44d9-aa2d-ba327aeba208.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]ethylenediamine,35141-30-1, Oral ( EPA OPPTS 870.1100): LD50 rat (male/female) = 2295 mg/kg bw (read across from CAS 1760 -24 -3) Inhalation ( EPA OPPTS 870.1300): LC50 rat (male/female) = 1.49 - 2.44 mg/L(read across from CAS 1760 -24 -3) Dermal ( EPA OPPTS 870.1200): LD50 rabbit > 2000 mg/kg bw (read across from CAS 1760 -24 -3) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7d961dc-e66f-4a75-bd5c-cafaa57e53ba/documents/6d3e46e0-5fd3-4576-a084-e7ee355f4787_665d71a0-2066-44d9-aa2d-ba327aeba208.html,,,,,, N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]ethylenediamine,35141-30-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7d961dc-e66f-4a75-bd5c-cafaa57e53ba/documents/6d3e46e0-5fd3-4576-a084-e7ee355f4787_665d71a0-2066-44d9-aa2d-ba327aeba208.html,,oral,LD50,"2,295 mg/kg bw",adverse effect observed, N-(2-aminoethyl)-N'-[3-(trimethoxysilyl)propyl]ethylenediamine,35141-30-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7d961dc-e66f-4a75-bd5c-cafaa57e53ba/documents/6d3e46e0-5fd3-4576-a084-e7ee355f4787_665d71a0-2066-44d9-aa2d-ba327aeba208.html,,inhalation,LC50,"1,490 mg/m3",adverse effect observed, "N-(2-chloroethyl)-4-[(2,6-dichloro-4-nitrophenyl)azo]-N-ethyl-m-toluidine",63741-10-6," Based on the results of combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the following No Observed Adverse Effect Levels (NOAELs) of DISPERSE BROWN 27 were established: Parental NOAEL: 150 mg/kg, based on changes in several haematology parameters and spleen at 500 mg/kg in females (The treatment related changes observed in the thyroid hormones were excluded in determining the NOAEL). Reproduction NOAEL: at least 500 mg/kg. Developmental NOAEL: 150 mg/kg, based on decreased body weight gain in male and female pups at 500 mg/kg (The treatment related changes observed in the thyroid hormones were excluded in determining the NOAEL). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2acf927-5fce-4a2d-bdc3-c8cb307e073b/documents/23a00265-43fe-4e20-b00a-ff0e749890a6_4a678b31-2c64-48b7-8097-badc167a11d7.html,,,,,, "N-(2-chloroethyl)-4-[(2,6-dichloro-4-nitrophenyl)azo]-N-ethyl-m-toluidine",63741-10-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2acf927-5fce-4a2d-bdc3-c8cb307e073b/documents/23a00265-43fe-4e20-b00a-ff0e749890a6_4a678b31-2c64-48b7-8097-badc167a11d7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "N-(2-chloroethyl)-4-[(2,6-dichloro-4-nitrophenyl)azo]-N-ethyl-m-toluidine",63741-10-6," The oral LD50 value of Disperse Brown 27 in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. Based on these results, Disperse Brown 27 does not have to be classified and has no obligatory labelling requirement for acute oral toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2acf927-5fce-4a2d-bdc3-c8cb307e073b/documents/6af1de3c-fed1-4baa-b44d-5c104130f7de_4a678b31-2c64-48b7-8097-badc167a11d7.html,,,,,, N-(2-chloroethyl)pyrrolidine hydrochloride,7250-67-1, LD50 was estimated to be 2629 mg/kg bw when Sprague-Dawley male and female rats were orally exposed with 1-(2-chloroethyl)pyrrolidine hydrochloride by gavage. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b69d32e6-2434-48f9-a43c-306706ef8105/documents/6b66b44b-4993-42a0-8d15-3438bd0199bf_0050e98c-8a97-4962-8873-e8bab582bbe9.html,,,,,, N-(2-chloroethyl)pyrrolidine hydrochloride,7250-67-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b69d32e6-2434-48f9-a43c-306706ef8105/documents/6b66b44b-4993-42a0-8d15-3438bd0199bf_0050e98c-8a97-4962-8873-e8bab582bbe9.html,,oral,LD50,"2,629 mg/kg bw",no adverse effect observed, N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide,23949-66-8,90d-feeding study: NOEL = 600 mg/kg bw/d (10.000 ppm males and females) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b5b5326-9be2-4921-ba16-5219552d7d7e/documents/IUC5-6f4ff734-dd4f-4749-b8e5-d30ba2af9b88_74bafebd-41f1-4a74-8baa-70b7f5820c98.html,,,,,, N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide,23949-66-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b5b5326-9be2-4921-ba16-5219552d7d7e/documents/IUC5-6f4ff734-dd4f-4749-b8e5-d30ba2af9b88_74bafebd-41f1-4a74-8baa-70b7f5820c98.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide,23949-66-8,"Acute Toxicity (oral, rat, OECD 423): > 2000 mg/kg bwAcute Toxicity (dermal, rat. similar to OECD 402): > 5000 mg/kg bwAcute Toxicity (inhalation): data lacking ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b5b5326-9be2-4921-ba16-5219552d7d7e/documents/IUC5-de386ba1-4384-4f4f-b754-b022a3ced115_74bafebd-41f1-4a74-8baa-70b7f5820c98.html,,,,,, N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide,23949-66-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b5b5326-9be2-4921-ba16-5219552d7d7e/documents/IUC5-de386ba1-4384-4f4f-b754-b022a3ced115_74bafebd-41f1-4a74-8baa-70b7f5820c98.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, N-(2-ethoxyphenyl)-N'-(2-ethylphenyl)oxamide,23949-66-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b5b5326-9be2-4921-ba16-5219552d7d7e/documents/IUC5-de386ba1-4384-4f4f-b754-b022a3ced115_74bafebd-41f1-4a74-8baa-70b7f5820c98.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, N-(2-ethoxyphenyl)-N'-(4-isododecylphenyl)oxamide,82493-14-9," Daily oral (gavage) administration of test item “Hostavin 3206 LIQ (Impoverished Xylene)” to Wistar rats at the dose levels 100, 300 and 1000 mg/kg Bwt/day for 2 weeks prior to mating, during mating, and 2 weeks post mating (males) or 2 weeks prior to mating, during mating, and during pregnancy until 13 days after delivery (females) had no effects on general health, body weights, food intake, pre-coital time, gestation length, mating and fertility parameters. Functional observations did not reveal any test item related changes at all the tested doses. The survival indices were not altered by the treatment. The test item administration did not reveal any changes in the hematology, coagulation and clinical chemistry parameters. There were no test item related changes in the terminal body weights, organ weights and organs weight ratios in both males and females. Gross examination of pups on LD 13 did not reveal any gross changes. There were no microscopic changes observed in both males and females. Further, the male and female reproductive organs did not reveal any changes. The thyroid stimulating hormone (TSH) and thyroxine (T4) levels in adult rats and pups remained unaffected by test itemadministration. No test item-related changes were observed in organ weights, gross pathology and histopathology of thyroid gland of parental rats and pups. The No Observed Adverse Effect Level (NOAEL) of is considered to be 1000 mg/kg Bwt/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80b6556e-0e6c-42c5-8e23-ce7a02c60866/documents/b2a9ee84-acc6-4f95-8cca-5b36cf4c36ea_e9563f8e-d7f4-4a4d-95fc-22086a7e8f9a.html,,,,,, N-(2-ethoxyphenyl)-N'-(4-isododecylphenyl)oxamide,82493-14-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80b6556e-0e6c-42c5-8e23-ce7a02c60866/documents/b2a9ee84-acc6-4f95-8cca-5b36cf4c36ea_e9563f8e-d7f4-4a4d-95fc-22086a7e8f9a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat N-(2-ethoxyphenyl)-N'-(4-isododecylphenyl)oxamide,82493-14-9,"Acute toxicity after single oral application was tested in male and female rats, which received up to 10,000 mg/kg bw. No animal died or showed clinical symptoms/macroscopic anomalies. The necropsy did not reveal any effect. The LD50 value for acute oral toxicity was considered to be greater than 10,000 mg/kg bw. Due to the findings described above (LD50 oral in rats greater than 10,000 mg/kg bw) Hostavin 3206 does not have to be classified as acute orally toxic. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80b6556e-0e6c-42c5-8e23-ce7a02c60866/documents/IUC5-027e04c1-0213-4649-a146-447da600730a_e9563f8e-d7f4-4a4d-95fc-22086a7e8f9a.html,,,,,, N-(2-ethoxyphenyl)-N'-(4-isododecylphenyl)oxamide,82493-14-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80b6556e-0e6c-42c5-8e23-ce7a02c60866/documents/IUC5-027e04c1-0213-4649-a146-447da600730a_e9563f8e-d7f4-4a4d-95fc-22086a7e8f9a.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, N-(2-ethylhexyl)-1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]naphthalen-2-amine,56358-09-9," Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, oral (gavage), rat (Wistar Han) M/F, OECD guideline 422, GLP: NOAEL <160 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f304ea85-7643-44dc-8495-27fb0c42bac4/documents/6bb349d7-aa3d-4765-b78c-97aa23b1a063_1840f7fa-d358-44ab-80db-8492a69bd0e8.html,,,,,, N-(2-ethylhexyl)-1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]naphthalen-2-amine,56358-09-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f304ea85-7643-44dc-8495-27fb0c42bac4/documents/6bb349d7-aa3d-4765-b78c-97aa23b1a063_1840f7fa-d358-44ab-80db-8492a69bd0e8.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,160 mg/kg bw/day,,rat N-(2-ethylhexyl)-1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]naphthalen-2-amine,56358-09-9,"Acute oral toxicity: LD50 > 2000 mg/kg bw, EU Method B.1 tris, GLP compliantAcute dermal toxicity: LD50 > 2000 mg/kg bw, EU Method B.3, GLP compliant ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f304ea85-7643-44dc-8495-27fb0c42bac4/documents/IUC5-6c892088-577e-4215-a0ae-4bd723e137a3_1840f7fa-d358-44ab-80db-8492a69bd0e8.html,,,,,, N-(2-ethylhexyl)-1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]naphthalen-2-amine,56358-09-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f304ea85-7643-44dc-8495-27fb0c42bac4/documents/IUC5-6c892088-577e-4215-a0ae-4bd723e137a3_1840f7fa-d358-44ab-80db-8492a69bd0e8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, N-(2-ethylhexyl)-1-[[2-methyl-4-[(2-methylphenyl)azo]phenyl]azo]naphthalen-2-amine,56358-09-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f304ea85-7643-44dc-8495-27fb0c42bac4/documents/IUC5-6c892088-577e-4215-a0ae-4bd723e137a3_1840f7fa-d358-44ab-80db-8492a69bd0e8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, N-(2-ethylhexyl)-1-[[3-methyl-4-[(3-methylphenyl)azo]phenyl]azo]naphthalen-2-amine,56358-10-2," Acute oral toxicity: LD50 > 2000 mg/kg bw, ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a8d1949-fd30-4cbf-afe5-8ab200f292c3/documents/397d62c3-1c3d-46a8-8e59-81af44d1d7dc_5a1805c4-8d6d-4ac9-bc12-5f6fbf06822c.html,,,,,, N-(2-ethylhexyl)-1-[[3-methyl-4-[(3-methylphenyl)azo]phenyl]azo]naphthalen-2-amine,56358-10-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a8d1949-fd30-4cbf-afe5-8ab200f292c3/documents/397d62c3-1c3d-46a8-8e59-81af44d1d7dc_5a1805c4-8d6d-4ac9-bc12-5f6fbf06822c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, N-(2-hydroxyethyl)-N-[2-[(1-oxooctyl)amino]ethyl]-β-alanine,64265-45-8," subacute (28 d repated dose toxicity study) repeated dose toxicity study oral (gavage), rat (Wistar) m/f (OECD TG 407; GLP; RL1), dose levels: 0, 50, 150, 1000 mg/kg bw/day; NOAEL >/= 1000 mg a.i./kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f3f7e25-8898-49c1-89ad-c7733d87c6d4/documents/01504e95-1971-401e-a697-377760f99b9a_b324f760-e45a-487e-a982-d169233c6e03.html,,,,,, N-(2-hydroxyethyl)-N-[2-[(1-oxooctyl)amino]ethyl]-β-alanine,64265-45-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f3f7e25-8898-49c1-89ad-c7733d87c6d4/documents/01504e95-1971-401e-a697-377760f99b9a_b324f760-e45a-487e-a982-d169233c6e03.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat N-(2-hydroxyethyl)-N-[2-[(1-oxooctyl)amino]ethyl]-β-alanine,64265-45-8," Oral LD50 > 2000 mg a.i./kg bw; OECD TG 423 / Method B.1, rat; oral: gavage; RL1, GLP Dermal LD50 > 2000 mg a.i./kg bw; OECD TG 402 / Method B.1, rat; RL1, GLP Inhalation: no relevant route of exposure ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f3f7e25-8898-49c1-89ad-c7733d87c6d4/documents/f85b6180-a6c3-4fbd-8ef7-ca16a1e34751_b324f760-e45a-487e-a982-d169233c6e03.html,,,,,, N-(2-hydroxyethyl)-N-[2-[(1-oxooctyl)amino]ethyl]-β-alanine,64265-45-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f3f7e25-8898-49c1-89ad-c7733d87c6d4/documents/f85b6180-a6c3-4fbd-8ef7-ca16a1e34751_b324f760-e45a-487e-a982-d169233c6e03.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, N-(2-hydroxyethyl)-N-[2-[(1-oxooctyl)amino]ethyl]-β-alanine,64265-45-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f3f7e25-8898-49c1-89ad-c7733d87c6d4/documents/f85b6180-a6c3-4fbd-8ef7-ca16a1e34751_b324f760-e45a-487e-a982-d169233c6e03.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, N-(2-hydroxypropyl)benzenesulphonamide,35325-02-1, Wistar rats were administrated with 150.300.600 mg/kg B.W. n-(2 -hydroxylpropyl)benzene sulfonamide ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad0b3896-0707-4a56-84fd-63a2df46b526/documents/5072162f-90f1-428f-9f16-f440f6b1646e_27a0fa3f-4398-47aa-8eea-b41416263e6e.html,,,,,, N-(2-hydroxypropyl)benzenesulphonamide,35325-02-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad0b3896-0707-4a56-84fd-63a2df46b526/documents/5072162f-90f1-428f-9f16-f440f6b1646e_27a0fa3f-4398-47aa-8eea-b41416263e6e.html,Chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat N-(2-hydroxypropyl)benzenesulphonamide,35325-02-1, The acute oral LD50 of the test material in the wistar rat was determined to be >2000 mg/kg bodyweight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad0b3896-0707-4a56-84fd-63a2df46b526/documents/1849270e-9072-4fe5-b910-85a903444978_27a0fa3f-4398-47aa-8eea-b41416263e6e.html,,,,,, N-(2-phenoxyphenyl)methanesulphonamide,51765-51-6, LD50 was estimated to be 1200 mg/kg bw in rat and 1100 mg/kg bw in mice when mice and rats were orally exposed with N-(2-phenoxyphenyl)methanesulfonamide. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3784466-88c9-4478-b4c4-546519a440f4/documents/414f7ef4-7565-4951-9eff-1214f4d4d655_5cae4e9e-54ca-4ba6-a0a3-9ea27b8e43cb.html,,,,,, N-(2-phenoxyphenyl)methanesulphonamide,51765-51-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3784466-88c9-4478-b4c4-546519a440f4/documents/414f7ef4-7565-4951-9eff-1214f4d4d655_5cae4e9e-54ca-4ba6-a0a3-9ea27b8e43cb.html,,oral,LD50,"1,200 mg/kg bw",adverse effect observed, N-(3-(trimethoxysilyl)propyl)ethylenediamine,1760-24-3," The key study for the inhalation route is a 90-day inhalation test (Charles River, 2017) conducted to OECD TG 413 and in compliance with GLP in which Sprague Dawley rats were exposed to an aerosol of N-[3-(trimethoxysilyl)propyl] ethylenediamine at concentration of 5, 15 or 45 mg/m3, 5 days per week. The NOAEC for local effects was 15 mg/m3, based on effects on the respiratory tract. There were no adverse systemic effects. The key study for the oral route is a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test conducted to OECD TG 422 and in compliance with GLP (Dow Corning Corporation, 2002a). The NOAEL from this study was at least 500 mg/kg bw/day as no adverse effects were observed at any dose tested. A nine-day dermal toxicity study (Bushy Run Research Center, 1993) supported the finding of low repeated dose systemic toxicity.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2a8c301-a5c4-4c54-b1dc-0f3c4748f008/documents/a2fb33b4-94db-4728-9d2c-6baf9a04b2eb_9b3c9637-4c0c-402f-a72c-717443d8cade.html,,,,,, N-(3-(trimethoxysilyl)propyl)ethylenediamine,1760-24-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2a8c301-a5c4-4c54-b1dc-0f3c4748f008/documents/a2fb33b4-94db-4728-9d2c-6baf9a04b2eb_9b3c9637-4c0c-402f-a72c-717443d8cade.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat N-(3-(trimethoxysilyl)propyl)ethylenediamine,1760-24-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2a8c301-a5c4-4c54-b1dc-0f3c4748f008/documents/a2fb33b4-94db-4728-9d2c-6baf9a04b2eb_9b3c9637-4c0c-402f-a72c-717443d8cade.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,45 mg/m3,,rat N-(3-(trimethoxysilyl)propyl)ethylenediamine,1760-24-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2a8c301-a5c4-4c54-b1dc-0f3c4748f008/documents/a2fb33b4-94db-4728-9d2c-6baf9a04b2eb_9b3c9637-4c0c-402f-a72c-717443d8cade.html,Repeated dose toxicity – local effects,inhalation,NOAEC,15 mg/m3,adverse effect observed,rat N-(3-(trimethoxysilyl)propyl)ethylenediamine,1760-24-3," The key study for acute oral toxicity determined an LD50 value of 2295 mg/kg bw in rats, in a reliable study conducted according to an appropriate test protocol and in compliance with GLP (Dow Corning Corporation, 2001). The key study for acute inhalation toxicity determined an LC50 value of 1.49 - 2.44 mg/l in rats, in a reliable study conducted according to an appropriate test protocol and in compliance with GLP (Dow Corning Corporation, 2000a). The key study for acute dermal toxicity determined an LD50 value of >2000 mg/kg bw in rabbits, in a reliable limit test conducted according to an appropriate test protocol and in compliance with GLP (Dow Corning Corporation, 2000b). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2a8c301-a5c4-4c54-b1dc-0f3c4748f008/documents/9fd83226-4e71-4bdb-911b-f0b2a221aef3_9b3c9637-4c0c-402f-a72c-717443d8cade.html,,,,,, N-(3-(trimethoxysilyl)propyl)ethylenediamine,1760-24-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2a8c301-a5c4-4c54-b1dc-0f3c4748f008/documents/9fd83226-4e71-4bdb-911b-f0b2a221aef3_9b3c9637-4c0c-402f-a72c-717443d8cade.html,,oral,LD50,"2,295 mg/kg bw",adverse effect observed, N-(3-(trimethoxysilyl)propyl)ethylenediamine,1760-24-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2a8c301-a5c4-4c54-b1dc-0f3c4748f008/documents/9fd83226-4e71-4bdb-911b-f0b2a221aef3_9b3c9637-4c0c-402f-a72c-717443d8cade.html,,dermal,LD50,"> 2,000 mg/kg bw",adverse effect observed, N-(3-(trimethoxysilyl)propyl)ethylenediamine,1760-24-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2a8c301-a5c4-4c54-b1dc-0f3c4748f008/documents/9fd83226-4e71-4bdb-911b-f0b2a221aef3_9b3c9637-4c0c-402f-a72c-717443d8cade.html,,inhalation,LC50,"1,490 mg/m3",adverse effect observed, N-(3-aminopropyl)iminodiethanol,4985-85-7," In a study performed according to the OECD 422, N-(3-Aminopropyl)diethanolamine was administered by daily oral gavage followed by a 14-day recovery period to male and female Wistar Han rats at dose levels of 100, 300 and 1000 mg/kg/day. Based on these results, a parental No Observed Adverse Effect Level (NOAEL) of 300 mg/kg was established. In a study performed according to OECD 408, the test item was administred by oral route during 13 weeks followed by a 6 -week treatement free period. Under the experimental conditions of the study, the NOAEL (No Observed Adverse Effect Level) was established at 250 mg/kg/day based on multiple correlated effects observed at 650 mg/kg/day indicative of an impact on red blood cell mass and adverse microscopic lesions in several organs (erosions/ulcers in the forestomach and/or stomach in both sexes and tubular degeneration/necrosis in kidneys). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe9bd3c7-2979-4771-9a3b-704416484f9a/documents/IUC5-fd814036-487d-443e-9fdd-050823e10fa6_64b5d12e-ac02-4c1b-80fd-ce4e65b06888.html,,,,,, N-(3-aminopropyl)iminodiethanol,4985-85-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe9bd3c7-2979-4771-9a3b-704416484f9a/documents/IUC5-fd814036-487d-443e-9fdd-050823e10fa6_64b5d12e-ac02-4c1b-80fd-ce4e65b06888.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat N-(3-aminopropyl)iminodiethanol,4985-85-7,"The acute oral LD0 of N-(3-Aminopropyl)diethanolamine was found to be greater than 2,000 mg active ingredient/kg bodyweight in the Sprague-Dawley CD rats. The single dose acute dermal LD0 of N-(3-Aminopropyl)diethanolamine is greater than 2,000 mg/kg of body weight in male and female rats. No data is available for acute inhalation toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe9bd3c7-2979-4771-9a3b-704416484f9a/documents/IUC5-637ff4d3-d1bd-4b68-a42d-e0ad6578e35b_64b5d12e-ac02-4c1b-80fd-ce4e65b06888.html,,,,,, N-(3-aminopropyl)iminodiethanol,4985-85-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe9bd3c7-2979-4771-9a3b-704416484f9a/documents/IUC5-637ff4d3-d1bd-4b68-a42d-e0ad6578e35b_64b5d12e-ac02-4c1b-80fd-ce4e65b06888.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, N-(3-aminopropyl)iminodiethanol,4985-85-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe9bd3c7-2979-4771-9a3b-704416484f9a/documents/IUC5-637ff4d3-d1bd-4b68-a42d-e0ad6578e35b_64b5d12e-ac02-4c1b-80fd-ce4e65b06888.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N-(3-aminopropyl)-N- (C12-18 even numbered) alkyl-propane-1,3-diamine",1219458-12-4,An OECD 422 study on Cocodipropylenetriamine resulted to a LOAEL of 10 mg/kgbw/day based on foamy macrophage infiltration in the ileum and jejunum and foamy macrophage foci in the mesenteric lymph nodes observed at this dose level. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a87b030c-df17-48cc-b0d2-e66554bcea67/documents/IUC5-d3ab54f6-eb93-45fd-8359-8bc95c300147_18598fe5-c977-4dc0-8b5a-12186c88d234.html,,,,,, "N-(3-aminopropyl)-N- (C12-18 even numbered) alkyl-propane-1,3-diamine",1219458-12-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a87b030c-df17-48cc-b0d2-e66554bcea67/documents/IUC5-d3ab54f6-eb93-45fd-8359-8bc95c300147_18598fe5-c977-4dc0-8b5a-12186c88d234.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,10 mg/kg bw/day,,rat "N-(3-aminopropyl)-N- (C12-18 even numbered) alkyl-propane-1,3-diamine",1219458-12-4,Acute toxicity: Oral LD50 between 50 and 300 mg/kg for rat. The LD50 cut-off is 200 mg/kg bw.No data is available on acute toxicity via inhalation or dermal route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a87b030c-df17-48cc-b0d2-e66554bcea67/documents/IUC5-11b0b419-cec7-4b6a-8f9e-ab8ab7418fa7_18598fe5-c977-4dc0-8b5a-12186c88d234.html,,,,,, "N-(3-aminopropyl)-N- (C12-18 even numbered) alkyl-propane-1,3-diamine",1219458-12-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a87b030c-df17-48cc-b0d2-e66554bcea67/documents/IUC5-11b0b419-cec7-4b6a-8f9e-ab8ab7418fa7_18598fe5-c977-4dc0-8b5a-12186c88d234.html,,oral,LD50,200 mg/kg bw,adverse effect observed, "N'-(3-aminopropyl)-N,N-dimethylpropane-1,3-diamine",10563-29-8,"No repeated dose toxicity study is available on N'-(3-aminopropyl) -N, N-dimethylpropane-1,3-diamine. Its potential toxicity is evaluated by read across from repeated dose toxicity studies performed on the analogue substances, diethylenetriamine (CAS no. 111-40-0) and its dihydrochloride salt (CAS no. 3488-90-2) and dipropylenetriamine (CAS no. 56-18-8). By oral route, the 13-week NOAEL was 41 mg/kg bw/d for diethylenetriamine in rats, and the NOAEL for the F0 parental animals was found to be 15 mg/kg bw/d in an OECD 422 study performed on dipropylenetriamine. By inhalation exposure the 3-week NOAEL was 550 mg/m3 for diethylenetriamine in rats. By dermal route, the chronic NOAEL was 56.3 mg/kg bw three times a week in mice for diethylenetriamine. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c232e7b-d142-437a-9fdb-70a5d0c4a159/documents/4c82a748-a5b6-4a48-a13e-a9a32e721cf3_52f03bd1-b2e4-4feb-b185-8debf0d179a2.html,,,,,, "N'-(3-aminopropyl)-N,N-dimethylpropane-1,3-diamine",10563-29-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c232e7b-d142-437a-9fdb-70a5d0c4a159/documents/4c82a748-a5b6-4a48-a13e-a9a32e721cf3_52f03bd1-b2e4-4feb-b185-8debf0d179a2.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,550 mg/m3,,rat "N'-(3-aminopropyl)-N,N-dimethylpropane-1,3-diamine",10563-29-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c232e7b-d142-437a-9fdb-70a5d0c4a159/documents/4c82a748-a5b6-4a48-a13e-a9a32e721cf3_52f03bd1-b2e4-4feb-b185-8debf0d179a2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,41 mg/kg bw/day,,rat "N'-(3-aminopropyl)-N,N-dimethylpropane-1,3-diamine",10563-29-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c232e7b-d142-437a-9fdb-70a5d0c4a159/documents/4c82a748-a5b6-4a48-a13e-a9a32e721cf3_52f03bd1-b2e4-4feb-b185-8debf0d179a2.html,Chronic toxicity – systemic effects,dermal,NOAEL,56.3 mg/kg bw/day,,mouse "N'-(3-aminopropyl)-N,N-dimethylpropane-1,3-diamine",10563-29-8,"In an acute oral toxicity study, the LD50 of N'-(3-aminopropyl) -N, N-dimethylpropane-1,3-diamine was 1669 (1249-2086) mg/kg for male and female rats. The most notable clinical abnormalities observed included a decrease in spontaneous activity, dyspnea, coma and body weight loss. Reddish or black colouration of the digestive tract, spleen and/or liver was observed in the animals found dead. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c232e7b-d142-437a-9fdb-70a5d0c4a159/documents/b6208516-e623-482e-90ee-5f48239f7486_52f03bd1-b2e4-4feb-b185-8debf0d179a2.html,,,,,, "N'-(3-aminopropyl)-N,N-dimethylpropane-1,3-diamine",10563-29-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c232e7b-d142-437a-9fdb-70a5d0c4a159/documents/b6208516-e623-482e-90ee-5f48239f7486_52f03bd1-b2e4-4feb-b185-8debf0d179a2.html,,oral,LD50,"1,669 mg/kg bw",adverse effect observed, "N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide",81-68-5,"Based upon the results obtained in the 28-day repeated toxicity study, the NOAEL of the test substance is 100 mg/kg body weight for male and females rats when administered orally by gavage. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e110fbaa-1a2c-45c6-abb8-04f034b66307/documents/IUC5-bc6d485c-cda5-461d-ad30-c663f21f37d5_daacf5a9-321e-46a6-b2b0-af1376712c7d.html,,,,,, "N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide",81-68-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e110fbaa-1a2c-45c6-abb8-04f034b66307/documents/IUC5-bc6d485c-cda5-461d-ad30-c663f21f37d5_daacf5a9-321e-46a6-b2b0-af1376712c7d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide",81-68-5,"Acute toxicity: oral In the study, designated as key, a group of 10 Tif: RAIf (SPF) rats (5/sex/dose) received a single oral (gavage) dose of 2000 mg/kg bw of the test substance of ca. 93 % purity). No mortality was observed. Normal body weight gains were recorded in all the animals throughout the study. Piloerection, hunched posture and dyspnea were seen within 1 h of dosing. The animals recovered within 5-6 d. Terminal necropsy findings were normal. Under the study conditions, the oral LD50 of the test substance was > 2000 mg/kg bw (i.e. > 1860 mg a.i./L) in male/female rats. The conclusion that Disperse Red 086 has low toxicity on oral exposure was further supported by two oral studies conducted with FAT 36034/A and FAT 36034/B, where the LD50 were estimated to be >5000 and >15000 mg/kg bw, respectively.   Acute toxicity: inhalation Currently no study for assessment of acute inhalation toxicity of Disperse Red 086 is available. However, Disperse Red 086 was estimated to have low vapour pressure owing to high melting point, so the potential for the generation of inhalable forms is low. Synthesis and spray drying of this chemical is performed in a closed process; the final product consists of non-dusty granules. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets. Referring to the expected low volatility of the substance, the fact that the substance is imported into the EU in a formulated form as a dust-free powder or as a granulate, the exposure via inhalation is considered to be unlikely. The chemical showed low toxicity potential in the available acute oral toxicity stuies with no mortality or systemic toxicity upto 2000 mg/kg bw, hence it does not need to be classified as STOT SE. Taking above arguments into consideration, low toxicity potential is expected on acute exposure of Disperse Red 086 via inhalation route. Hence, safety for human health can be estimated via route to route extrapolation and testing by the inhalation route was considered scientifically not necessary.   Acute toxicity: dermal Currently no study to assess acute dermal toxicity of Disperse Red 086 is available. However, the molecular weight of the chemical is 422.5 g/mol, indicating it being large for dermal absorption. Hence, the dermal uptake for the chemical is expected to be limited. It was determined to have low water solubility of 3.26 mg/L, hence dermal uptake is likely to be low as the substance is considered as not sufficiently soluble in water to partition from the stratum corneum into the epidermis. Production and spray drying is performed in closed processes without isolation of reaction products. Isolated products consist either of liquid formulations or of dust free granules (non-dusty solid). In addition, the use of this substance will not result in aerosols, particles or droplets, so exposure to humans via the dermal route will be unlikely to occur. Risk management measures established for workers and professionals are considered sufficient to enable safe handling and use of the final products containing the formulated dye. No products for consumers are marketed, therefore exposure to consumers do not need to be taken into account for risk assessment. The chemical showed low toxicity potential in the available acute oral toxicity studies (LD50 >2000 mg/kg bw), with no mortality or systemic toxicity being seen, hence it does not need to be classified STOT SE. Similarly, absence of systemic toxicity in skin irritation as well as sensitization studies, further supports the conclusion that no adverse effects are expected for the chemical via the dermal route. Further, experience with similar chemical substances has demonstrated that it is very unlikely that toxicity related to the intrinsic properties of the chemical only show up upon dermal exposure and not after systemic application. Hence, low toxicity is expected on acute dermal exposure of Disperse Red 086 and testing by the dermal route was considered scientifically not necessary. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e110fbaa-1a2c-45c6-abb8-04f034b66307/documents/IUC5-17cc0e0b-efde-44e7-8d1f-9f8f8fdb605f_daacf5a9-321e-46a6-b2b0-af1376712c7d.html,,,,,, "N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)-4-methylbenzenesulphonamide",81-68-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e110fbaa-1a2c-45c6-abb8-04f034b66307/documents/IUC5-17cc0e0b-efde-44e7-8d1f-9f8f8fdb605f_daacf5a9-321e-46a6-b2b0-af1376712c7d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)benzenesulphonamide",69563-51-5,"Based upon the results obtained in the repeated dose toxicity study with reproduction and developmental screening, the NOAEL was set at 100 mg/kg bw/day for male and females rats when administered orally by gavage. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d29cb1e2-3026-498c-ac90-40ce19974d4b/documents/IUC5-e41c5e58-0c69-4e76-903d-f2ae0bc530e3_dfdbba5b-473f-478b-9473-bf6a5b49295a.html,,,,,, "N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)benzenesulphonamide",69563-51-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d29cb1e2-3026-498c-ac90-40ce19974d4b/documents/IUC5-e41c5e58-0c69-4e76-903d-f2ae0bc530e3_dfdbba5b-473f-478b-9473-bf6a5b49295a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)benzenesulphonamide",69563-51-5,The acute oral toxicity (LD50) in male and female rats was found to be greater than 2000 mg/kg body weight ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d29cb1e2-3026-498c-ac90-40ce19974d4b/documents/IUC5-76c04314-a29d-4a26-b08f-22793a2baf40_dfdbba5b-473f-478b-9473-bf6a5b49295a.html,,,,,, "N-(4-amino-9,10-dihydro-3-methoxy-9,10-dioxo-1-anthryl)benzenesulphonamide",69563-51-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d29cb1e2-3026-498c-ac90-40ce19974d4b/documents/IUC5-76c04314-a29d-4a26-b08f-22793a2baf40_dfdbba5b-473f-478b-9473-bf6a5b49295a.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "N-(4-chloro-2,5-dimethoxyphenyl)-2-[[2,5-dimethoxy-4-[(phenylamino)sulphonyl]phenyl]azo]-3-oxobutyramide",12225-18-2,"In a subacute repeated oral-gavage study (OECD 422) the test item, the close analogue Pigment Yellow 1, was administered at dosages of 100, 300, and 1000 mg/kg body weight/day. Test item was administered to male rats for 32 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum. Under the conditions of this study, no adverse effects were found in males or females up to the highest dose level of 1000 mg/kg bw/day. Reproduction and development were not affected by the treatment. Mating performance, fertility, duration of gestation, corpora lutea count, implantation rate, post implantation and postnatal loss or litter size were similar in the control and all dose groups. There were no test item-related findings in pups noted during the first litter check, the first 4 days post partum or during the necropsy, pups body weights and body weight gain were not affected by the treatment at any dose level. Based on these results, the NOAEL (No Observed Adverse Effect Level) for general toxicity in males and females and for reproduction/developmental toxicity was considered to be 1000 mg/kg bw/day, the highest dose level used. A subchronic (90-day) toxicity study in Fischer F344 rats was performed with a close analogue (Pigment Yellow 74) of the test item. Groups of 10 male and 10 female rats received 0, 50, 200 and 1000 mg/kg/day by oral gavage in corn oil for 90 days. The study included additional control and high dose groups of 6 males and 6 females each analyzed after a 4-week recovery period. All animals survived until scheduled termination without any toxic signs in life. In haematology, clinical biochemistry and urinalysis some scattered significant differences, altogether without a clear dose response and all only minor in severity, were noted. Post mortem examination including histopathology did not reveal any test substance related toxic alterations. The test substance caused elevated liver weights in the high dosed females. As there were no corresponding histopathological or clinical-biochemical alterations found, the most likely interpretation is an adaptive response by enzyme induction. No parallel trend was present in the males. The effects did not persist until the end of the recovery period. No other test substance-related effect was noted. The No-observed-adverse-effect-level (NOAEL) of the test item was 1000 mg/kg bw/day in both sexes. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable and valid ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/99999843-c1f2-4028-ba74-bc32315b6b92/documents/abe5063d-eacf-4abc-850b-fce8c213676e_332c9f23-0308-499c-a783-f2d48eaf9951.html,,,,,, "N-(4-chloro-2,5-dimethoxyphenyl)-2-[[2,5-dimethoxy-4-[(phenylamino)sulphonyl]phenyl]azo]-3-oxobutyramide",12225-18-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/99999843-c1f2-4028-ba74-bc32315b6b92/documents/abe5063d-eacf-4abc-850b-fce8c213676e_332c9f23-0308-499c-a783-f2d48eaf9951.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N-(4-chloro-2,5-dimethoxyphenyl)-2-[[2,5-dimethoxy-4-[(phenylamino)sulphonyl]phenyl]azo]-3-oxobutyramide",12225-18-2,"A single oral application of a close structural analogue (Pigment Yellow 65) to rats at a dose of 2000 mg/kg body weight was associated with no signs of toxicity or mortality. The median lethal dose after a single oral administration to female rats, observed over a period of 14 days:LD50 > 2000 mg/kg body weight. The acute dermal median lethal dose (LD50) of a close structural analogue (Pigment Yellow 1) in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): valid and reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): valid and reliable ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99999843-c1f2-4028-ba74-bc32315b6b92/documents/889a4973-762e-415d-a42e-f58ed87b7910_332c9f23-0308-499c-a783-f2d48eaf9951.html,,,,,, "N-(4-chloro-2,5-dimethoxyphenyl)-2-[[2,5-dimethoxy-4-[(phenylamino)sulphonyl]phenyl]azo]-3-oxobutyramide",12225-18-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99999843-c1f2-4028-ba74-bc32315b6b92/documents/889a4973-762e-415d-a42e-f58ed87b7910_332c9f23-0308-499c-a783-f2d48eaf9951.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "N-(4-chloro-2,5-dimethoxyphenyl)-2-[[2,5-dimethoxy-4-[(phenylamino)sulphonyl]phenyl]azo]-3-oxobutyramide",12225-18-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99999843-c1f2-4028-ba74-bc32315b6b92/documents/889a4973-762e-415d-a42e-f58ed87b7910_332c9f23-0308-499c-a783-f2d48eaf9951.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Reaction mass of N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamideand N-(5-chloro-2-methylphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",99402-80-9,"Oral route: PR 112 The toxicity of the test item when given by oral administration (gavage) to groups of 5 rats per sex per dose for 28 consecutive days at dosages of 0, 100, 300 or 1000 mg/kg bw/day, for 7 days/week have been investigated. No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). Red staining of various body parts, red faeces and reddish contents of the gastro-intestinal tract noted among all groups treated with the test substance was considered to be related to staining properties of the test substance, and not to represent signs of systemic toxicity. No correlating histopathological abnormalities were noted. On the basis of these results, the high dose level of 1000 mg/kg/day was considered to be the No Observed Adverse Effect Level (NOAEL) for the test substance. PR022 A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test was performed according to OECD TG 422. The test item was administered to Sprague Dawley rats (12/sex/dose) by gavage at dose levels of 0, 100, 300 and 1000 mg/kg/day for a total of 37 days (males) and through mating, gestation and delivery until day 4 of lactation (females). No toxic effects were observed in this study except increased liver weights in males and females of the highest dose group. As the effects on liver weight were minimal (less than 10% weight changes) and not accompanied by any histopathological or biochemical changes these effects were judged not to be adverse. The no-observed-adverse-effect level (NOAEL) for repeated dose toxicity was 1000 mg/kg under the conditions of this study. There were no effects on reproduction or development. inhalation route:  PR112 The objective of the OECD TG 413 following study was to determine the toxic potential of the close analogue, Pigment Red 112, when administered for 6 hours/day, 5 days per week, for 13 consecutive weeks by flow-past nose-only inhalation route to Sprague Dawley rats. This study provides information on toxic effects, target organs, the possibility of cumulative effects, the reversibility of effects (after 90 and 180 days recovery period), and an estimate of the No Observed Adverse Effects Concentration (NOAEC). Based on the observed results, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item was found to be 30 mg/m³ (0,03 mg/L) after 90 days of exposure (highest concentration tested). The nominal dose of 0.03 mg/L (6 hrs/day, 5 days/week) corresponded to an actual exposure concentration in males and females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d7535b2-79c0-4513-baf0-a42ef85dd526/documents/5328e587-7c1a-4df1-8421-b609ba8e5c59_e7ca2148-9799-4433-ba9f-8bd65b8746d3.html,,,,,, "Reaction mass of N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamideand N-(5-chloro-2-methylphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",99402-80-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d7535b2-79c0-4513-baf0-a42ef85dd526/documents/5328e587-7c1a-4df1-8421-b609ba8e5c59_e7ca2148-9799-4433-ba9f-8bd65b8746d3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Reaction mass of N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamideand N-(5-chloro-2-methylphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",99402-80-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d7535b2-79c0-4513-baf0-a42ef85dd526/documents/5328e587-7c1a-4df1-8421-b609ba8e5c59_e7ca2148-9799-4433-ba9f-8bd65b8746d3.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,>= 30 mg/m3,,rat "Reaction mass of N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamideand N-(5-chloro-2-methylphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",99402-80-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d7535b2-79c0-4513-baf0-a42ef85dd526/documents/5328e587-7c1a-4df1-8421-b609ba8e5c59_e7ca2148-9799-4433-ba9f-8bd65b8746d3.html,Repeated dose toxicity – local effects,inhalation,NOAEC,>= 30 mg/m3,no adverse effect observed,rat "Reaction mass of N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamideand N-(5-chloro-2-methylphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",99402-80-9,"Single application of 10000 mg test substance per kg bw did not cause lethality in female Wistar-rats during the 14 day observation period, resulting in a LD50 > 10000 mg/kg bw. The Test item (<90% Pigment Red 112) did not cause any mortality or significant clinical signs or necropsy findings after single dermal application to male rats at 5000 mg/kg bw in an OECD guideline compliant study. The LD50 (male rat) was greater than 5000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d7535b2-79c0-4513-baf0-a42ef85dd526/documents/9d40b884-a130-4719-ba33-76cbc613e448_e7ca2148-9799-4433-ba9f-8bd65b8746d3.html,,,,,, "Reaction mass of N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamideand N-(5-chloro-2-methylphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",99402-80-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d7535b2-79c0-4513-baf0-a42ef85dd526/documents/9d40b884-a130-4719-ba33-76cbc613e448_e7ca2148-9799-4433-ba9f-8bd65b8746d3.html,,oral,LD50,"> 10,000 mg/kg bw",no adverse effect observed, "Reaction mass of N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamideand N-(5-chloro-2-methylphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",99402-80-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d7535b2-79c0-4513-baf0-a42ef85dd526/documents/9d40b884-a130-4719-ba33-76cbc613e448_e7ca2148-9799-4433-ba9f-8bd65b8746d3.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",5280-68-2,"PR146 (nano) A 28 -day repeated dose toxicity study with the test item administered by gavage to Wistar rats (SPF-bred; 5/sex/dose) was performed according to OECD TG 407. The dose levels for this study were 50, 250 and 1000 mg/kg bw/day. A control group was treated similarly with the vehicle, water, only. The dosing lasted for 28 days and a 14 day recovery group for controls and the high dosage group (1000 mg/kg bw/d) was included. The test item revealed no treatment-related findings. From the results presented in this report a No Observed Adverse Effect Level (NOAEL) for the test item of 1000 mg/kg bw/day was established.   Repeated inhalation toxicity: analogue PR112 Pigment Red 112, an analogous substance of PR146, was tested in a OECD TG 413 following study in order to determine the toxic potential of the test item, Pigment Red 112, when administered for 6 hours/day, 5 days per week, for 13 consecutive weeks by flow-past nose-only inhalation route to Sprague Dawley rats. This study provides information on toxic effects, target organs, the possibility of cumulative effects, the reversibility of effects (after 90 and 180 days recovery period), and an estimate of the No Observed Adverse Effects Concentration (NOAEC). Based on the observed results, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item was found to be 30 mg/m³ (0,03 mg/L) after 90 days of exposure (highest concentration tested). The nominal dose of 0.03 mg/L (6 hrs/day, 5 days/week) corresponded to an actual exposure concentration in males and females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5abb4c1a-3c62-4b32-bfa0-01c5490eceb8/documents/01303f5e-f2c8-4803-b5fa-908da1b1c324_9d74faa4-8a93-4a53-a77c-d23439ff7fa2.html,,,,,, "N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",5280-68-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5abb4c1a-3c62-4b32-bfa0-01c5490eceb8/documents/01303f5e-f2c8-4803-b5fa-908da1b1c324_9d74faa4-8a93-4a53-a77c-d23439ff7fa2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",5280-68-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5abb4c1a-3c62-4b32-bfa0-01c5490eceb8/documents/01303f5e-f2c8-4803-b5fa-908da1b1c324_9d74faa4-8a93-4a53-a77c-d23439ff7fa2.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat "N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",5280-68-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5abb4c1a-3c62-4b32-bfa0-01c5490eceb8/documents/01303f5e-f2c8-4803-b5fa-908da1b1c324_9d74faa4-8a93-4a53-a77c-d23439ff7fa2.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat "N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",5280-68-2,"Acute oral toxicity  A single oral application of 10000 mg Pigment Red 146 per kg bw did not cause lethality in female Wistar-rats during the 14 day observation period, resulting in a LD50 > 10000 mg/kg bw. Acute inhalation toxicity    The test item, Pigment Red 188, a close analogue of Pigment Red 146, did not cause any mortality or significant clinical signs or necropsy findings after single acute inhalation (4 hours) of 5.05 mg/L pigment dust in male Wistar rats. Therefore, the Median Lethal Concentration (LC50) value of the test item is more than 5.05 mg/L of chamber air. Acute dermal toxicity The Test item (<90% Pigment Red 112, a close analogue of PR146) did not cause any mortality or significant clinical signs or necropsy findings after single dermal application to male rats at 5000 mg/kg bw in an OECD guideline compliant study. The LD50 (male rat) was greater than 5000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5abb4c1a-3c62-4b32-bfa0-01c5490eceb8/documents/58c71ea6-326d-4682-839f-412a5f5261f3_9d74faa4-8a93-4a53-a77c-d23439ff7fa2.html,,,,,, "N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",5280-68-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5abb4c1a-3c62-4b32-bfa0-01c5490eceb8/documents/58c71ea6-326d-4682-839f-412a5f5261f3_9d74faa4-8a93-4a53-a77c-d23439ff7fa2.html,,oral,LD50,"> 10,000 mg/kg bw",no adverse effect observed, "N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",5280-68-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5abb4c1a-3c62-4b32-bfa0-01c5490eceb8/documents/58c71ea6-326d-4682-839f-412a5f5261f3_9d74faa4-8a93-4a53-a77c-d23439ff7fa2.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "N-(4-chloro-2,5-dimethoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide",5280-68-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5abb4c1a-3c62-4b32-bfa0-01c5490eceb8/documents/58c71ea6-326d-4682-839f-412a5f5261f3_9d74faa4-8a93-4a53-a77c-d23439ff7fa2.html,,inhalation,LC50,> 5.05 mg/L,no adverse effect observed, N-(4-chlorophenyl)-2-[(4-methyl-2-nitrophenyl)azo]-3-oxobutyramide,57206-89-0,Read across prediction for the target substance LD50: >2000 mg/kg bwLD50 value of the source substance (PY 3): 8285 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acf89011-b19e-44fb-ad4e-e1bad9c65860/documents/IUC5-624728c6-cf47-4e02-aa11-637f608abf91_2aaa748e-b556-46f5-b1d4-0397c0b6816a.html,,,,,, N-(4-chlorophenyl)-2-[(4-methyl-2-nitrophenyl)azo]-3-oxobutyramide,57206-89-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acf89011-b19e-44fb-ad4e-e1bad9c65860/documents/IUC5-624728c6-cf47-4e02-aa11-637f608abf91_2aaa748e-b556-46f5-b1d4-0397c0b6816a.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, N-(4-chlorophenyl)-3-hydroxy-4-[(2-methyl-5-nitrophenyl)azo]naphthalene-2-carboxamide,6410-30-6, Acute oral toxicity: LD50 was estimated to be 2103 mg/kg bw when Tif:MAGf male and female rats were orally exposed with N-(4-chlorophenyl)-3-hydroxy-4-[(E)-2-(2-methyl-5-nitrophenyl)diazen-1-yl]naphthalene-2-carboxamide. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/448d806c-f6a6-47e9-9d4d-92ccbf42ea87/documents/a2567493-3a42-4c7b-8fa2-679688f39d50_5e5a7642-f896-47c5-a85c-f6818d31c3fd.html,,,,,, N-(4-chlorophenyl)-3-hydroxy-4-[(2-methyl-5-nitrophenyl)azo]naphthalene-2-carboxamide,6410-30-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/448d806c-f6a6-47e9-9d4d-92ccbf42ea87/documents/a2567493-3a42-4c7b-8fa2-679688f39d50_5e5a7642-f896-47c5-a85c-f6818d31c3fd.html,,oral,LD50,"2,103 mg/kg bw",no adverse effect observed, "N-(4-ethoxyphenyl)-3-hydroxy-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide",5012-29-3,"Repeated oral toxicity: The toxicity of the close analogue Pigment Red 112 when given by oral administration (gavage) to groups of 5 rats per sex per dose for 28 consecutive days at dosages of 0, 100, 300 or 1000 mg/kg bw/day, for 7 days/week have been investigated. No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). Red staining of various body parts, red faeces and reddish contents of the gastro-intestinal tract noted among all groups treated with the test substance was considered to be related to staining properties of the test substance, and not to represent a sign of toxicity. No correlating histopathological abnormalities were noted. On the basis of these results, the high dose level of 1000 mg/kg/day was considered to be the No-Observed-Adverse-Effect Level (NOAEL) for the close analogue Pigment Red 112. Repeated dermal toxicity: The dermal route was waived; substance is not classified for this endpoint. The substance is considered not to exert any local or systemic adverse effects.   Repeated inhalation toxicity: The objective of this study was to determine the toxic potential of the close analogue Pigment Red 112 when administered for 6 hours/day, 5 days per week, for 13 consecutive weeks by flow-past nose-only inhalation route to Sprague Dawley rats. This study provides information on toxic effects, target organs, the possibility of cumulative effects, the reversibility of effects (after 90 and 180 days recovery period), and an estimate of the No Observed Adverse Effects Concentration (NOAEC). Based on the observed results, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item was found to be 30 mg/m³ (0,03 mg/L) after 90 days of exposure. The nominal dose of 0.03 mg/L (6 hrs/day, 5 days/week) corresponded to an actual exposure concentration in males and females. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): reliable and valid Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): reliable and valid Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable and valid ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0021668-8508-4845-97d3-6aa0cfd67b8c/documents/465b23a3-3545-4d64-ad3a-2f0bf6d7983f_b324a216-105d-4182-8fb7-ca22f0893bbf.html,,,,,, "N-(4-ethoxyphenyl)-3-hydroxy-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide",5012-29-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0021668-8508-4845-97d3-6aa0cfd67b8c/documents/465b23a3-3545-4d64-ad3a-2f0bf6d7983f_b324a216-105d-4182-8fb7-ca22f0893bbf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N-(4-ethoxyphenyl)-3-hydroxy-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide",5012-29-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0021668-8508-4845-97d3-6aa0cfd67b8c/documents/465b23a3-3545-4d64-ad3a-2f0bf6d7983f_b324a216-105d-4182-8fb7-ca22f0893bbf.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat "N-(4-ethoxyphenyl)-3-hydroxy-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide",5012-29-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0021668-8508-4845-97d3-6aa0cfd67b8c/documents/465b23a3-3545-4d64-ad3a-2f0bf6d7983f_b324a216-105d-4182-8fb7-ca22f0893bbf.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat "N-(4-ethoxyphenyl)-3-hydroxy-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide",5012-29-3,"The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. The mean median Lethal Concentration (LC50) of a close analogue Pigment Red 188 is more than 5.05 mg/L air in Wistar rats. The dermal LD50 was determined in the analogue Pigment Red 170 to be > 2000 mg / kg body weight. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable without restriction Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): valid and reliable Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): reliable with acceptable restrictions ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0021668-8508-4845-97d3-6aa0cfd67b8c/documents/1636a220-b8f6-4d13-884e-fae699d2999c_b324a216-105d-4182-8fb7-ca22f0893bbf.html,,,,,, "N-(4-ethoxyphenyl)-3-hydroxy-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide",5012-29-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0021668-8508-4845-97d3-6aa0cfd67b8c/documents/1636a220-b8f6-4d13-884e-fae699d2999c_b324a216-105d-4182-8fb7-ca22f0893bbf.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "N-(4-ethoxyphenyl)-3-hydroxy-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide",5012-29-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0021668-8508-4845-97d3-6aa0cfd67b8c/documents/1636a220-b8f6-4d13-884e-fae699d2999c_b324a216-105d-4182-8fb7-ca22f0893bbf.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "N-(4-ethoxyphenyl)-3-hydroxy-4-[(2,4,5-trichlorophenyl)azo]naphthalene-2-carboxamide",5012-29-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0021668-8508-4845-97d3-6aa0cfd67b8c/documents/1636a220-b8f6-4d13-884e-fae699d2999c_b324a216-105d-4182-8fb7-ca22f0893bbf.html,,inhalation,LC50,> 5.05 mg/L,no adverse effect observed, N-(5-chloro-2-methoxyphenyl)-2-[(2-methoxy-4-nitrophenyl)azo]-3-oxobutyramide,15993-42-7,"Key study: Repeated dose toxicity by oral route, following OECD Guideline 422 (GLP study). The NOAEL of the test substance after a repeated oral exposure of 31 days in males and from 40 to 57 days in females was determined to be 1000 mg/kg bw/day since no adverse effects were observed at the highest dose tested.   Key study. Repeated dose toxicity by inhalation, following OECD Guideline 412 (GLP study). No treatment related effects were observed up to the highest dose tested of 1.35 mg/L after 28 days, 6 hours/day, 5 days/week of aerosolized test item inhalation exposure to rats. Thus, the NOEC is determined to be 1.35 mg/L.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb8f7166-5332-46e2-a38a-132d1fa6256f/documents/1b76d5d8-c154-4de9-824e-b203bd14c700_7f547023-fdae-4ede-a72c-a2dd11e92973.html,,,,,, N-(5-chloro-2-methoxyphenyl)-2-[(2-methoxy-4-nitrophenyl)azo]-3-oxobutyramide,15993-42-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb8f7166-5332-46e2-a38a-132d1fa6256f/documents/1b76d5d8-c154-4de9-824e-b203bd14c700_7f547023-fdae-4ede-a72c-a2dd11e92973.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat N-(5-chloro-2-methoxyphenyl)-2-[(2-methoxy-4-nitrophenyl)azo]-3-oxobutyramide,15993-42-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb8f7166-5332-46e2-a38a-132d1fa6256f/documents/1b76d5d8-c154-4de9-824e-b203bd14c700_7f547023-fdae-4ede-a72c-a2dd11e92973.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,1.35 mg/L,,rat N-(5-chloro-2-methoxyphenyl)-2-[(2-methoxy-4-nitrophenyl)azo]-3-oxobutyramide,15993-42-7,"Acute oral toxicity: Key study. Test method according to OECD 401, GLP study. Single application of the limit dose of 2000 mg test substance per kg bw did not cause lethality in male and female Sprague-Dawley rats during the 14 day observation period, resulting in a LD50 > 2000 mg/kg bw. Acute inhalation toxicity: Key study. Test method according to OECD 412, GLP study: In a 28 day (subacute) inhalation toxicity study performed with the test substance no treatment related effects or deaths were observed up to the maximum attainable concentration (1.35 mg/L air) after 28 days, 6 hours/day, 5 days/week of aerosolized test item inhalation exposure to rats. It is not deemed appropriate to perform another inhalation study since it will be not technically possible to achieve higher concentrations. However, this result can be used to conclude that LC50 is higher than 1.35 mg/l air. Acute dermal toxicity: Key study. Test method according to OECD 402, GLP study. The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb8f7166-5332-46e2-a38a-132d1fa6256f/documents/3c184ff0-24ba-46d6-9d8c-16e1a48e3304_7f547023-fdae-4ede-a72c-a2dd11e92973.html,,,,,, N-(5-chloro-2-methoxyphenyl)-2-[(2-methoxy-4-nitrophenyl)azo]-3-oxobutyramide,15993-42-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb8f7166-5332-46e2-a38a-132d1fa6256f/documents/3c184ff0-24ba-46d6-9d8c-16e1a48e3304_7f547023-fdae-4ede-a72c-a2dd11e92973.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, N-(5-chloro-2-methoxyphenyl)-2-[(2-methoxy-4-nitrophenyl)azo]-3-oxobutyramide,15993-42-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb8f7166-5332-46e2-a38a-132d1fa6256f/documents/3c184ff0-24ba-46d6-9d8c-16e1a48e3304_7f547023-fdae-4ede-a72c-a2dd11e92973.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, N-(5-chloro-2-methoxyphenyl)-2-[(2-methoxy-4-nitrophenyl)azo]-3-oxobutyramide,15993-42-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb8f7166-5332-46e2-a38a-132d1fa6256f/documents/3c184ff0-24ba-46d6-9d8c-16e1a48e3304_7f547023-fdae-4ede-a72c-a2dd11e92973.html,,inhalation,LC50,> 1.35 mg/L,no adverse effect observed, N-(5-chloro-2-methoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide,67990-05-0, Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test: NOAEL(systemic) = 1000 mg/kg bw/day (read-across from analogue substance C.I. Pigment Red 22 [3-hydroxy-4-[(2-methyl-5-nitrophenyl)diazenyl]-N-phenyl-2-naphthamide]) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89956b6b-5b1e-45dc-8bf9-cfbba8074b0d/documents/6535d697-79d6-4b85-9806-917df37aa163_6a248454-6e2f-4930-a7a9-6802880f9ac8.html,,,,,, N-(5-chloro-2-methoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide,67990-05-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89956b6b-5b1e-45dc-8bf9-cfbba8074b0d/documents/6535d697-79d6-4b85-9806-917df37aa163_6a248454-6e2f-4930-a7a9-6802880f9ac8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat N-(5-chloro-2-methoxyphenyl)-3-hydroxy-4-[[2-methoxy-5-[(phenylamino)carbonyl]phenyl]azo]naphthalene-2-carboxamide,67990-05-0, Oral (OECD 423): LD50 (rat) > 2000 mg/kg bw Dermal (OECD 402): LD50 (rat) > 2000 mg/kg bw (read-across from analogue substance Pigment Red 170 [4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide]) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89956b6b-5b1e-45dc-8bf9-cfbba8074b0d/documents/91805529-9473-42eb-8f0a-c670409bfaef_6a248454-6e2f-4930-a7a9-6802880f9ac8.html,,,,,, N-(butoxymethyl)acrylamide,1852-16-0," The sub-chronic toxicity of the read-across substance, acrylamide, was assessed using male and female rats administered the test material in drinking water for up to 93 days. The NOAEL was ≤ 0.2 mg/kg bw/day (nominal) for males and females based on clinical signs, body weight and weight gain, haematology and clinical biochemistry. The LOAEL was ≤ 1.0 mg/kg bw/day. The chronic toxicity of the read-across substance was assessed according to OECD Test Guideline 453 on rats. Male and female rats were administered with material in drinking water daily for two years. The NOAEL was 0.5 mg/kg bw/day in male and female rats based on mortality, body weight and weight gain and both neo-plastic and non-neoplastic histopathology. This study is considered the key study based on both the study duration and a more statistically robust conclusion. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b46335e8-d5e0-4c89-ac11-033422ad1d1c/documents/1d5cfec6-bea7-4bcd-a2c1-efcf361e2c2d_488a8f2c-497b-477c-8d79-b7ed2b6127fc.html,,,,,, N-(butoxymethyl)acrylamide,1852-16-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b46335e8-d5e0-4c89-ac11-033422ad1d1c/documents/1d5cfec6-bea7-4bcd-a2c1-efcf361e2c2d_488a8f2c-497b-477c-8d79-b7ed2b6127fc.html,Chronic toxicity – systemic effects,oral,NOAEL,0.5 mg/kg bw/day,,rat N-(butoxymethyl)acrylamide,1852-16-0," The acute toxicity of the test substance via the oral route was assessed using a limit method similar to OECD Test Guideline 420 using a fixed dose procedure in rats. The LD50 of the test material was > 1000 mg/kg bw.   The acute toxicity via inhalation of the read-across substance, acrylamide, was assessed in two studies, both using a method similar to OECD Test Guideline 433. The LC0 for the test material in rats by inhalation is greater than 12 mg/m3.   The acute toxicity of the test substance via the dermal route was assessed using a method similar to OECD Test Guideline 402 using a standard acute method. The LD50 of the test material is greater than 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b46335e8-d5e0-4c89-ac11-033422ad1d1c/documents/826488d3-e69d-40bf-af6c-c68993d41a3f_488a8f2c-497b-477c-8d79-b7ed2b6127fc.html,,,,,, N-(butoxymethyl)acrylamide,1852-16-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b46335e8-d5e0-4c89-ac11-033422ad1d1c/documents/826488d3-e69d-40bf-af6c-c68993d41a3f_488a8f2c-497b-477c-8d79-b7ed2b6127fc.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, N-(butoxymethyl)acrylamide,1852-16-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b46335e8-d5e0-4c89-ac11-033422ad1d1c/documents/826488d3-e69d-40bf-af6c-c68993d41a3f_488a8f2c-497b-477c-8d79-b7ed2b6127fc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, N-(butoxymethyl)acrylamide,1852-16-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b46335e8-d5e0-4c89-ac11-033422ad1d1c/documents/826488d3-e69d-40bf-af6c-c68993d41a3f_488a8f2c-497b-477c-8d79-b7ed2b6127fc.html,,inhalation,LC50,12 mg/m3,no adverse effect observed, N-(butoxymethyl)methacrylamide,5153-77-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4313b165-0dbe-4f6e-8c41-063ffd5fd66d/documents/1fa85d27-c0e2-4ba1-8289-bb1ed035a025_6960a7a3-9d41-4716-affc-12b268d496c1.html,,oral,LD50,720 mg/kg bw,adverse effect observed, N-(carbamoylmethyl)taurine,7365-82-4," In a reliable in vivo acute oral toxicity study, the substance was administered to 6 female Wistar rats in a single dose by oral gavage at a limit dose of 2000 mg/kg body weight. All (6/6 females) animals survived the dose of 2000 mg/kg body weight.The substance did not cause death or evident signs of toxicity. During the observation period of 14 days, no other signs of intoxication, change of health, nor any other adverse reactions were seen. Macroscopic examination of the animals at the end of the study did not reveal treatment-related changes. The oral LD50of the substance is considered to be greater than 2000 mg/kg body weight after single oral administration to female Wistar rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c789d1dd-fa9d-4bec-b064-f5778fdcaeed/documents/779df13b-66c9-44db-bab3-8d5d7fa91eea_13fd26dd-6fc7-4b5f-81d2-fb44e7d92148.html,,,,,, N-(carbamoylmethyl)taurine,7365-82-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c789d1dd-fa9d-4bec-b064-f5778fdcaeed/documents/779df13b-66c9-44db-bab3-8d5d7fa91eea_13fd26dd-6fc7-4b5f-81d2-fb44e7d92148.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine",7691-02-3," In the key 90-day oral repeated dose toxicity study with the registered substance, N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine, conducted according to OECD Test Guideline 408 and in compliance with GLP, the concluded NOAEL for systemic toxicity for male and female rats was ≥ 50 mg/kg bw/day based on no observed adverse effects at the highest dose tested ( BSL Bioservice Munich, 2020). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f996fde6-80a3-46a5-863c-452568c0659e/documents/d3785b2e-0f9a-4af3-95cb-86bbd7bc1175_bb697dc7-545e-4a93-b9a5-24c837eda337.html,,,,,, "N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine",7691-02-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f996fde6-80a3-46a5-863c-452568c0659e/documents/d3785b2e-0f9a-4af3-95cb-86bbd7bc1175_bb697dc7-545e-4a93-b9a5-24c837eda337.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine",7691-02-3," There is one acute oral toxicity study on N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine. There are no dermal or inhalation studies available for N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine. Therefore, reliable key acute dermal and acute inhalation toxicity data from the structurally-related substance, 1,1,1,3,3,3-hexamethyldisilazane (CAS 999-97-3) have been read-across. In the key acute oral toxicity study, conducted according to a guideline similar to the now-deleted OECD Test Guideline 401, but without information on GLP compliance (Bayer AG, 1985), the LD50for N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine was concluded to be 0.57 ml/kg bw (equivalent to 469 mg/kg bw based on a density of 0.882 g/cm³). In the key acute dermal toxicity study (Bushy Run Research Center, 1981), conducted according to a protocol similar to OECD Test Guideline 402, but without information on GLP compliance, the LD50for 1,1,1,3,3,3-hexamethyldisilazane (CAS 999-97-3)was concluded to be 547 mg/kg bw in females and 589 mg/kg bw in males (based on a density of 0.774 g/m³). In the key acute inhalation toxicity study (Dow Corning Corporation, 2007), conducted according to OECD Test Guideline 403 and in compliance with GLP, the LC50for 1,1,1,3,3,3-hexamethyldisilazane (CAS 999-97-3) was concluded to be 1516 ppm (equivalent to 10007 mg/m³). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f996fde6-80a3-46a5-863c-452568c0659e/documents/e83cd2d9-a77c-4c84-82fb-801713032718_bb697dc7-545e-4a93-b9a5-24c837eda337.html,,,,,, "N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine",7691-02-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f996fde6-80a3-46a5-863c-452568c0659e/documents/e83cd2d9-a77c-4c84-82fb-801713032718_bb697dc7-545e-4a93-b9a5-24c837eda337.html,,oral,LD50,469 mg/kg bw,adverse effect observed, "N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine",7691-02-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f996fde6-80a3-46a5-863c-452568c0659e/documents/e83cd2d9-a77c-4c84-82fb-801713032718_bb697dc7-545e-4a93-b9a5-24c837eda337.html,,dermal,LD50,547 mg/kg bw,adverse effect observed, "N-(dimethylvinylsilyl)-1,1-dimethyl-1-vinylsilylamine",7691-02-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f996fde6-80a3-46a5-863c-452568c0659e/documents/e83cd2d9-a77c-4c84-82fb-801713032718_bb697dc7-545e-4a93-b9a5-24c837eda337.html,,inhalation,LC50,"10,007 mg/m3",adverse effect observed, N-(hydroxymethyl)methacrylamide,923-02-4,N-methylol methacrylamide was assessed for repeated dose toxicity in analogy to the structurally closely related methacrylamide. The systemic NOAEL of 9.1 mg/kg/d from a chronic oral study in rats is in good accordance with a NOAEL of approximately 18 mg/kg/d derived from a subchronic inhalation study. Inhalation is not a relevant pathway for N-methylol methacrylamide which has a very low intrinsic vapour pressure and exists in practice as aqueous solution only. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7abfef48-81aa-4384-8f56-c21b80f1a8c3/documents/IUC5-3446fda9-6bd0-41f0-9f34-e1e34f4d96a1_f6699533-33ce-4226-b41f-c130f581d651.html,,,,,, N-(hydroxymethyl)methacrylamide,923-02-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7abfef48-81aa-4384-8f56-c21b80f1a8c3/documents/IUC5-3446fda9-6bd0-41f0-9f34-e1e34f4d96a1_f6699533-33ce-4226-b41f-c130f581d651.html,Chronic toxicity – systemic effects,oral,NOAEL,9.1 mg/kg bw/day,,rat N-(hydroxymethyl)methacrylamide,923-02-4,"N-methylol methacrylamide is of moderate acute toxicity by the oral route LD50 (rat): 959 mg/kg.Based on the test results N-methylol methacrylamide is allocated to EU GHS and UN GHS acute oral category 4.Due to the low dermal absorption rate, acute dermal toxicity is not expected.Exposure via inhalation is negligible due to the very low vapour pressure and the handling of the substance as aqueous solution only. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7abfef48-81aa-4384-8f56-c21b80f1a8c3/documents/IUC5-3cac8ac0-6a81-4dd3-8b13-8d3a58880b20_f6699533-33ce-4226-b41f-c130f581d651.html,,,,,, N-(hydroxymethyl)methacrylamide,923-02-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7abfef48-81aa-4384-8f56-c21b80f1a8c3/documents/IUC5-3cac8ac0-6a81-4dd3-8b13-8d3a58880b20_f6699533-33ce-4226-b41f-c130f581d651.html,,oral,LD50,959 mg/kg bw,adverse effect observed, N-(methoxymethyl)acrylamide,3644-11-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9810cca-bcdc-40ea-a4a5-bcd16c0eac96/documents/7b225143-68d0-4bef-9a97-b41b34027bef_78db4292-f349-438f-9c0c-ce956fac1f83.html,,oral,LD50,166 mg/kg bw,adverse effect observed, N-(methoxymethyl)methacrylamide,3644-12-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89fc0720-b5e4-446c-a129-eb09f5092c58/documents/07b03b05-f590-4c5e-bf16-ca3d48f5ec7b_d7ea9ed9-72a1-401e-84fc-02890c4e87c6.html,,oral,LD50,"1,685 mg/kg bw",adverse effect observed, N-(N6-trifluoroacetyl-L-lysyl)-L-proline,103300-89-6," The results of the 4-week oral toxicity study conducted according to OECD TG 407 on ε-Trifluoroacetyl-L-lysyl-L-proline in Wistar rats indicate, that the test substance produces only mild, adaptive effects even at very high doses and after prolonged exposure. Although there are minor effects even at the low dose, these effects are not interpreted as toxicity, but as adaption to the unusually high peptide supply or the slight local irritant effects. The liver and the stomach displayed the highest sensitivity to the presence of the test substance. The NOAEL is estimated as above 1000 mg/kg bw/day. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/7aee42f2-2db5-4532-81fb-8c627cc8dc38/documents/5cdba246-8811-4ced-b84a-dcfdb035699c_e0b88322-6c15-4080-9147-5801238a201b.html,,,,,, N-(N6-trifluoroacetyl-L-lysyl)-L-proline,103300-89-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/7aee42f2-2db5-4532-81fb-8c627cc8dc38/documents/5cdba246-8811-4ced-b84a-dcfdb035699c_e0b88322-6c15-4080-9147-5801238a201b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat N-(N6-trifluoroacetyl-L-lysyl)-L-proline,103300-89-6, In an acute oral toxicity study conducted according to OECD TG 401 the LD50 values were above a dose of 5110 mg/kg in male and female rats. In an acute dermal toxicity study conducted according to OECD TG 402 the LD50 values for male as well as female rabbits were above 2000 mg/kg bw. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7aee42f2-2db5-4532-81fb-8c627cc8dc38/documents/445d39d0-8573-47a0-86f7-352dfa1785ab_e0b88322-6c15-4080-9147-5801238a201b.html,,,,,, N-(N6-trifluoroacetyl-L-lysyl)-L-proline,103300-89-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7aee42f2-2db5-4532-81fb-8c627cc8dc38/documents/445d39d0-8573-47a0-86f7-352dfa1785ab_e0b88322-6c15-4080-9147-5801238a201b.html,,oral,LD50,"5,110 mg/kg bw",no adverse effect observed, N-(N6-trifluoroacetyl-L-lysyl)-L-proline,103300-89-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7aee42f2-2db5-4532-81fb-8c627cc8dc38/documents/445d39d0-8573-47a0-86f7-352dfa1785ab_e0b88322-6c15-4080-9147-5801238a201b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, N-(phenylsulphonyl)benzenesulphonamide,2618-96-4," Acute oral toxicity:  Acute oral toxicity dose (LD50) for N-(phenylsulfonyl) benzenesulfonamide (CAS no: 2618-96-4) was predicted based on OECD QSAR toolbox 3512 mg/kg bw; Danish (Q)SAR Database for rat 4200 mg mg/kg bw and for mice 4000 mg mg/kg bw; and different studies available on structurally similar read across substances Diphenyl acetonitrile (CAS No. 86-29-3) conducted by Sustainability Support Services (Europe) AB >2000 mg/kg body weight and 4-anilino-3-nitro-N-phenylbenzenesulphonamide (5124-25-4) conducted by J-CHECK Japan Chemicals Collaborative Knowledge database >2000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, N-(phenylsulfonyl) benzenesulfonamide cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: N-(phenylsulfonyl) benzenesulfonamide (CAS no: 2618-96-4) has very low vapour pressure (7.79E-07 Pa at 25°C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for N-(phenylsulfonyl) benzenesulfonamide (CAS no: 2618-96-4) was predicted based on OECD QSAR toolbox 2656 mg/kg bwand differentstudies available for the structurally similar read across substance Diphenyl acetonitrile (CAS No. 86-29-3) > 2000 mg/kg bw and N,N-dimethyl-2,2-diphenylacetamide (957-51-7)> 6320 mg/kg bw. All these studies concluded that the LD50 value is>2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, N-(phenylsulfonyl) benzenesulfonamide cannot be classified for acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68c3c9d4-4570-4bc0-ab8a-67fd3d746832/documents/d3b8bc9a-593f-4887-b733-adc4ae3e7fcf_988cec19-f33d-4f15-85b9-337490fca84a.html,,,,,, N-(phenylsulphonyl)benzenesulphonamide,2618-96-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68c3c9d4-4570-4bc0-ab8a-67fd3d746832/documents/d3b8bc9a-593f-4887-b733-adc4ae3e7fcf_988cec19-f33d-4f15-85b9-337490fca84a.html,,oral,LD50,"3,512 mg/kg bw",no adverse effect observed, N-(phenylsulphonyl)benzenesulphonamide,2618-96-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68c3c9d4-4570-4bc0-ab8a-67fd3d746832/documents/d3b8bc9a-593f-4887-b733-adc4ae3e7fcf_988cec19-f33d-4f15-85b9-337490fca84a.html,,dermal,LD50,"2,656 mg/kg bw",no adverse effect observed, N-(tert-butyl)benzylamine,3378-72-1," Distilled NBTB showed toxicity by the oral route, but showed no systemic toxicity by the dermal route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9aa9e5b4-b35c-4a72-92ad-c9d9b5e60986/documents/e8251068-f22c-4b24-9216-4507653fce2c_e9058ab0-2e28-499e-b390-6dde4ff80200.html,,,,,, N-(tert-butyl)benzylamine,3378-72-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9aa9e5b4-b35c-4a72-92ad-c9d9b5e60986/documents/e8251068-f22c-4b24-9216-4507653fce2c_e9058ab0-2e28-499e-b390-6dde4ff80200.html,,oral,LD50,370 mg/kg bw,adverse effect observed, N-(tert-butyl)benzylamine,3378-72-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9aa9e5b4-b35c-4a72-92ad-c9d9b5e60986/documents/e8251068-f22c-4b24-9216-4507653fce2c_e9058ab0-2e28-499e-b390-6dde4ff80200.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, N-(tri(hydroxymethyl)methyl)glycine,5704-04-1," In an acute oral toxicity study in rats conducted according to OECD 423, the target substance Tricine showed no mortality at the limit dose of 2000 mg/kg bw. Hence, the LD50 value was considered to exceed 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9cbfba8-c512-4024-9ad2-64e200fb1665/documents/3cb7aca0-e0f4-475f-b1b8-b03f4646aeb0_be79c5f1-2b4f-4770-a923-7e4c6e800c01.html,,,,,, "N,N'-(10,15,16,17-tetrahydro-5,10,15,17-tetraoxo-5H-dinaphtho[2,3-a:2',3'-i]carbazole-6,9-diyl)bis(benzamide)",2379-81-9, LD50 > 15000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/570bfe5a-d9b1-4cdc-a33f-6ef7a1a1c2e1/documents/313502fb-afe8-4218-b4f5-ccdf0e0fc814_6b7d1388-8d95-4e75-bd36-fccfd0c52232.html,,,,,, "N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",40618-31-3,The substance does not cause treatment-related adverse effects up to the limit dose upon subacute oral exposure. This assessment is based on a GLP and OECD 407 compliant study with Pigment Red 166 (CAS 3905-19-9) (Vuos 2009b) and a GLP and OECD 422 compliant study with Pigment Red 220 (CAS 68259-05-2) (BASF 2012b). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3b90736-ce63-472f-bc45-05533d1b8c2c/documents/bf2da8dc-3b6f-4061-8623-00be3dacb03c_3e733be6-6b73-4109-a745-bffee5f400cb.html,,,,,, "N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",40618-31-3,"- Oral: LD50 > 2000 mg/kg bw, rat, according to OECD TG 423, GLP compliant, 2006, K1 - Inhalation: LC50 > 2.002 mg/L air, rat, according to OECD TG 403, GLP compliant, 2022, K1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3b90736-ce63-472f-bc45-05533d1b8c2c/documents/36475174-cc31-4c94-8c4d-a1be83540498_3e733be6-6b73-4109-a745-bffee5f400cb.html,,,,,, "N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",40618-31-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3b90736-ce63-472f-bc45-05533d1b8c2c/documents/36475174-cc31-4c94-8c4d-a1be83540498_3e733be6-6b73-4109-a745-bffee5f400cb.html,,oral,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, "N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",40618-31-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3b90736-ce63-472f-bc45-05533d1b8c2c/documents/36475174-cc31-4c94-8c4d-a1be83540498_3e733be6-6b73-4109-a745-bffee5f400cb.html,,inhalation,discriminating conc.,> 2.002 mg/L,no adverse effect observed, "N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[[2-chloro-5-(trifluoromethyl)phenyl]azo]-3-hydroxynaphthalene-2-carboxamide]",52238-92-3,"Repeated oral toxicity: The toxicity of the close analogue Pigment Red 166, when given by oral administration (gavage) to groups of 5 rats per sex per dose for 28 consecutive days at dosages of 0, 160, or 1000 mg/kg bw/day, for 7 days/week have been investigated in a GLP and OECD 407 compliant study. Pathological examination revealed possibly treatment changes in two of the males at the end of application period. Enlarged paraortal nodes (2 of 5 males, none in females) and enlarged mesenterial nodes with changed colour (1 of five males, none in females) were recorded at the highest dose level of 1000 mg/kg bw/day. Histopathology showed reactive hyperplasia of unknown severity of the paraaortic lymph nodes in the two males of the high dose group. On the basis of these results, the high dose level of 400 mg/kg/day was considered to be the No-Observed-Effect Level (NOEL) for Pigment Red 166. This data is supported by an OECD 422 compliant study with the structural analogue Pigment Red 220. No adverse toxicological relevant effects were observed throughout the study. Therefore, the NOAEL for repeated oral exposure was considered to be 1000 mg/kg bw/ day. Repeated dermal toxicity: The dermal route was waived; substance is not classified for this endpoint. The substance is considered not to exert any local or systemic adverse effects.   Repeated inhalation toxicity: The objective of the OECD TG 413 following study was to determine the toxic potential of the test item, Pigment Red 112, when administered for 6 hours/day, 5 days per week, for 13 consecutive weeks by flow-past nose-only inhalation route to Sprague Dawley rats. This study provides information on toxic effects, target organs, the possibility of cumulative effects, the reversibility of effects (after 90 and 180 days recovery period), and an estimate of the No Observed Adverse Effects Concentration (NOAEC). Based on the observed results, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item, PV-Fast Scarlet 4RF was found to be 0.1 mg/L when exposed for 6 hours/day, 5 days/week, for 13 weeks by flow-past nose-only inhalation route to Sprague Dawley rats. The nominal dose of 0.1 mg/L 6 hrs/day 5 days/week) corresponded to an actual exposure concentration in males and females.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b3bee7e-a0ce-4a96-b291-709074926c47/documents/7ef548f3-92d0-481a-accf-73a3f9304a56_864841ab-64f4-424b-91b9-6c63b3dea8d8.html,,,,,, "N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[[2-chloro-5-(trifluoromethyl)phenyl]azo]-3-hydroxynaphthalene-2-carboxamide]",52238-92-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b3bee7e-a0ce-4a96-b291-709074926c47/documents/7ef548f3-92d0-481a-accf-73a3f9304a56_864841ab-64f4-424b-91b9-6c63b3dea8d8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat "N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[[2-chloro-5-(trifluoromethyl)phenyl]azo]-3-hydroxynaphthalene-2-carboxamide]",52238-92-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b3bee7e-a0ce-4a96-b291-709074926c47/documents/7ef548f3-92d0-481a-accf-73a3f9304a56_864841ab-64f4-424b-91b9-6c63b3dea8d8.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,>= 100 mg/m3,,rat "N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[[2-chloro-5-(trifluoromethyl)phenyl]azo]-3-hydroxynaphthalene-2-carboxamide]",52238-92-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b3bee7e-a0ce-4a96-b291-709074926c47/documents/7ef548f3-92d0-481a-accf-73a3f9304a56_864841ab-64f4-424b-91b9-6c63b3dea8d8.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,>= 100 mg/m3,,rat "N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[[2-chloro-5-(trifluoromethyl)phenyl]azo]-3-hydroxynaphthalene-2-carboxamide]",52238-92-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b3bee7e-a0ce-4a96-b291-709074926c47/documents/7ef548f3-92d0-481a-accf-73a3f9304a56_864841ab-64f4-424b-91b9-6c63b3dea8d8.html,Repeated dose toxicity – local effects,inhalation,NOAEC,>= 100 mg/m3,no adverse effect observed,rat "N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[[2-chloro-5-(trifluoromethyl)phenyl]azo]-3-hydroxynaphthalene-2-carboxamide]",52238-92-3,Pigment Red 242 and its structure analogues were non toxic upon acute oral toxicity testing in rat with doses being tested in the range of 2000 mg/kg bw. They are non toxic upon acute skin contact based on experimental data with Pigment Red 144 obtained with rabbits and based on the physico-chemical properties which indicate absent or very low skin permeability.Regarding inhalation toxicity the structural analogue Pigment Red 220 was found to be non toxic in rat exposed with whole body 4 h with up to 2200 mg/m³ air.     ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b3bee7e-a0ce-4a96-b291-709074926c47/documents/3846c8f3-688f-4599-8304-36e248ffb167_864841ab-64f4-424b-91b9-6c63b3dea8d8.html,,,,,, "N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[[2-chloro-5-(trifluoromethyl)phenyl]azo]-3-hydroxynaphthalene-2-carboxamide]",52238-92-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b3bee7e-a0ce-4a96-b291-709074926c47/documents/3846c8f3-688f-4599-8304-36e248ffb167_864841ab-64f4-424b-91b9-6c63b3dea8d8.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[[2-chloro-5-(trifluoromethyl)phenyl]azo]-3-hydroxynaphthalene-2-carboxamide]",52238-92-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b3bee7e-a0ce-4a96-b291-709074926c47/documents/3846c8f3-688f-4599-8304-36e248ffb167_864841ab-64f4-424b-91b9-6c63b3dea8d8.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N,N'-(2,5-dichloro-1,4-phenylene)bis[4-[[2-chloro-5-(trifluoromethyl)phenyl]azo]-3-hydroxynaphthalene-2-carboxamide]",52238-92-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b3bee7e-a0ce-4a96-b291-709074926c47/documents/3846c8f3-688f-4599-8304-36e248ffb167_864841ab-64f4-424b-91b9-6c63b3dea8d8.html,,inhalation,LC50,"> 2,200 mg/m3",no adverse effect observed, "N,N'-(2,5-dimethyl-1,4-phenylene)bis[4-[(5-chloro-2-methylphenyl)azo]-3-hydroxynaphthalene-2-carboxamide",79665-24-0,"Pigment Red 262 was found to non toxic upon acute oral toxicity testing in rats with an LD50 above 5000 mg/kg bw. It is non toxic upon acute skin contact based on experimental data with Pigment Red 144 obtained with rabbits and based on the physico-chemical properties, which indicate absent or very low skin permeability. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable and valid. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77f99e94-9c37-4ff5-bc6f-00cab914be00/documents/7f8117ee-fbf6-4471-9ad8-46021708c4aa_d3e69a8f-63a3-4d6c-8f1c-e46df81c90e9.html,,,,,, "N,N'-(2,5-dimethyl-1,4-phenylene)bis[4-[(5-chloro-2-methylphenyl)azo]-3-hydroxynaphthalene-2-carboxamide",79665-24-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77f99e94-9c37-4ff5-bc6f-00cab914be00/documents/7f8117ee-fbf6-4471-9ad8-46021708c4aa_d3e69a8f-63a3-4d6c-8f1c-e46df81c90e9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "N,N'-(2-chloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",5280-78-4,The substance does not cause treatment-related adverse effects up to the limit dose upon subacute oral exposure. This assessment is based on a GLP and OECD 407 compliant study with Pigment Red 166 (CAS 3905-19-9) (Vuos 2009b) and a GLP and OECD 422 compliant study with Pigment Red 220 (CAS 68259-05-2) (BASF 2012b). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66637972-89cd-42db-b6c9-e7a25cc9fc53/documents/2efe958d-2782-4304-9194-a82dbe0c74b5_858e78dd-5071-4e3e-a38d-6d133676c9e8.html,,,,,, "N,N'-(2-chloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",5280-78-4,"- Oral: LD50 > 10000 mg/kg bw, rat, comparable to OECD TG 401, no GLP, 1972, K2 - Inhalation: LC50 > 2.002 mg/L air, rat, according to OECD TG 403, GLP compliant, 2022, K1 - Dermal: LD50 > 2000 mg/kg bw, rabbits, comparable to OECD TG 402, no GLP, 1978, K2 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66637972-89cd-42db-b6c9-e7a25cc9fc53/documents/62dcb07a-002f-43e6-bb37-7d7b99a6645c_858e78dd-5071-4e3e-a38d-6d133676c9e8.html,,,,,, "N,N'-(2-chloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",5280-78-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66637972-89cd-42db-b6c9-e7a25cc9fc53/documents/62dcb07a-002f-43e6-bb37-7d7b99a6645c_858e78dd-5071-4e3e-a38d-6d133676c9e8.html,,oral,discriminating dose,"> 10,000 mg/kg bw",no adverse effect observed, "N,N'-(2-chloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",5280-78-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66637972-89cd-42db-b6c9-e7a25cc9fc53/documents/62dcb07a-002f-43e6-bb37-7d7b99a6645c_858e78dd-5071-4e3e-a38d-6d133676c9e8.html,,dermal,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, "N,N'-(2-chloro-1,4-phenylene)bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",5280-78-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66637972-89cd-42db-b6c9-e7a25cc9fc53/documents/62dcb07a-002f-43e6-bb37-7d7b99a6645c_858e78dd-5071-4e3e-a38d-6d133676c9e8.html,,inhalation,discriminating conc.,> 2.002 mg/L,no adverse effect observed, "N,N'-(2-chloro-1,4-phenylene)bis[4-[(4-chloro-2-nitrophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",35869-64-8," Oral: NOAEL >= 1000 mg/kg bw/day, rat, according to OECD422, GLP-compliant, K1, 2022 Inhalation: NOAEC = 5 mg/m3, rat, short-term inhalation study, GLP-compliant, K1, 2022 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d12cbc70-48c6-4bfe-9a3f-98d9d876c6a7/documents/aac1c27c-6192-4544-a0bf-a732259e2551_c8ba5cfa-56bb-453f-841e-f15fee89ddb4.html,,,,,, "N,N'-(2-chloro-1,4-phenylene)bis[4-[(4-chloro-2-nitrophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",35869-64-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d12cbc70-48c6-4bfe-9a3f-98d9d876c6a7/documents/aac1c27c-6192-4544-a0bf-a732259e2551_c8ba5cfa-56bb-453f-841e-f15fee89ddb4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N,N'-(2-chloro-1,4-phenylene)bis[4-[(4-chloro-2-nitrophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",35869-64-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d12cbc70-48c6-4bfe-9a3f-98d9d876c6a7/documents/aac1c27c-6192-4544-a0bf-a732259e2551_c8ba5cfa-56bb-453f-841e-f15fee89ddb4.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,60 mg/m3,,rat "N,N'-(2-chloro-1,4-phenylene)bis[4-[(4-chloro-2-nitrophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",35869-64-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d12cbc70-48c6-4bfe-9a3f-98d9d876c6a7/documents/aac1c27c-6192-4544-a0bf-a732259e2551_c8ba5cfa-56bb-453f-841e-f15fee89ddb4.html,Repeated dose toxicity – local effects,inhalation,NOAEC,5 mg/m3,adverse effect observed,rat "N,N'-(2-chloro-1,4-phenylene)bis[4-[(4-chloro-2-nitrophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",35869-64-8, CAS 35869 -64 -8 was found to be non toxic upon acute oral toxicity testing in rats with 10 000 mg/kg bw. A study for acute inhalation toxicity in rats (OECD 403) is ongoing. Read-across assessment shows absence of adverse effects of > 1.7 mg/m3. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d12cbc70-48c6-4bfe-9a3f-98d9d876c6a7/documents/779641e9-b35f-4ef5-9335-c03da6656279_c8ba5cfa-56bb-453f-841e-f15fee89ddb4.html,,,,,, "N,N'-(2-chloro-1,4-phenylene)bis[4-[(4-chloro-2-nitrophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",35869-64-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d12cbc70-48c6-4bfe-9a3f-98d9d876c6a7/documents/779641e9-b35f-4ef5-9335-c03da6656279_c8ba5cfa-56bb-453f-841e-f15fee89ddb4.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "N,N''-(4-methyl-m-phenylene)bis[N',N'-dimethylurea]",17526-94-2," Two reliable oral repeated toxicity studies (OECD 422 and OECD 408, GLP) conducted in Wistar rats are available for TDI-Urone 80. In a key subchronic toxicity study (OECD TG 408, GLP) in rats no adverse effects on mortality, clinical signs, body weight, food consumption, hematology, clinical chemistry, organ weights, or gross and histologic pathology were observed upon treatment with TDI-Urone 80. Based on the results of the study, the NOAEL was established as 1000 mg/kg/bw/day. In combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422, GLP) in rats no significant adverse effects have been reported up to the limit dose of 1000 mg/kg/d. The NOAEL for systemic toxicity was established at 1000 mg/kg bw/day based on the results of the study.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4696166a-ad28-4a48-9b2f-0eba0fbe7dac/documents/IUC5-ab4db34a-324d-4adf-ab8e-238936207b7e_561836c4-6ce9-4145-8005-9e32ddafa490.html,,,,,, "N,N''-(4-methyl-m-phenylene)bis[N',N'-dimethylurea]",17526-94-2," An acute oral and dermal toxicity study according to OECD 423 and OECD 402, respectively are available. Both are establishing a LD0 of 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4696166a-ad28-4a48-9b2f-0eba0fbe7dac/documents/IUC5-ac9c93ad-2b3f-4bbc-8194-2eea7dd775fe_561836c4-6ce9-4145-8005-9e32ddafa490.html,,,,,, "N,N''-(4-methyl-m-phenylene)bis[N',N'-dimethylurea]",17526-94-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4696166a-ad28-4a48-9b2f-0eba0fbe7dac/documents/IUC5-ac9c93ad-2b3f-4bbc-8194-2eea7dd775fe_561836c4-6ce9-4145-8005-9e32ddafa490.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N,N''-(4-methyl-m-phenylene)bis[N',N'-dimethylurea]",17526-94-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4696166a-ad28-4a48-9b2f-0eba0fbe7dac/documents/IUC5-ac9c93ad-2b3f-4bbc-8194-2eea7dd775fe_561836c4-6ce9-4145-8005-9e32ddafa490.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N,N'-(ethoxymethylsilylene)bis[N-methylbenzamide]",16230-35-6, Key study: OECD Guideline 422. GLP study. The 28 -days NOAEL (oral) for repeated dose toxicity was considered to be 150 mg/kg bw/day for the female and male parental/adult generation based on the test item related adverse effects observed at 500 mg/kg bw/day: transient ataxia (mainly week 1) and diuresis (mainly week 3); decreased body weight gain in males (transient) with similar changes in food intake; increased liver and kidney weights and decrease thymus organ weights with macroscopical liver enlargement and small thymus) and hepatocellular hypertrophy and hepatocellular microvesicular vacuolation. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbf65f66-bd11-4c75-9498-58350a2f5135/documents/02d462b6-2ba2-45f6-8093-420ebb623df3_0ac90b2f-49da-4361-921d-fec345e71199.html,,,,,, "N,N'-(ethoxymethylsilylene)bis[N-methylbenzamide]",16230-35-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cbf65f66-bd11-4c75-9498-58350a2f5135/documents/02d462b6-2ba2-45f6-8093-420ebb623df3_0ac90b2f-49da-4361-921d-fec345e71199.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "N,N'-(ethoxymethylsilylene)bis[N-methylbenzamide]",16230-35-6," Acute toxicity: oral. Key study: OECD 423 and EU method B.1 tris. GLP study. The LD50 was found to be betwwen 300 and 2000 mg/kg bw, the LD50 cut-off of the test item may be considered as 500 mg/kg body weight by oral route in the rat. Acute toxicity: inhalation. Data waiving (study not necessary / other information available): The study does not need to be conducted because there is availabe data on oral and dermal acute toxicity of the substance. Acute toxicity: dermal. Key study: OECD 402 and EU B.3. GLP study. The dermal LD50 of the test item in rats is greater than 2000 mg/kg bw. Erythema was noted at 48h, but it was fully reversible at Day 3. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbf65f66-bd11-4c75-9498-58350a2f5135/documents/5b2a9421-d486-4eec-9f78-bb4e46fcd366_0ac90b2f-49da-4361-921d-fec345e71199.html,,,,,, "N,N'-(ethoxymethylsilylene)bis[N-methylbenzamide]",16230-35-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbf65f66-bd11-4c75-9498-58350a2f5135/documents/5b2a9421-d486-4eec-9f78-bb4e46fcd366_0ac90b2f-49da-4361-921d-fec345e71199.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "N,N'-(ethoxymethylsilylene)bis[N-methylbenzamide]",16230-35-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbf65f66-bd11-4c75-9498-58350a2f5135/documents/5b2a9421-d486-4eec-9f78-bb4e46fcd366_0ac90b2f-49da-4361-921d-fec345e71199.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N''-(isobutylidene)diurea",6104-30-9," A combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test (BASF AG, 2003) adequately adresses the repeated exposure with IBDU. NOAELs were 300 mg/kg bw/day for females (reduced body weight gain during pregnancy and lactation at 1000 mg/kg bw/day), and 1000 mg/kg bw/day for males (highest tested dose level). A subchronic repeated dose study according to OECD 408 (BASF SE, 2017) revealed a NOAEL for general systemic toxicity of 1000 mg/kg bw/day for male and female Wistar rats taking into account that tubular damage in the kidneys of male Wistar rats were a consequence of an α-nephropathy which does not represent a risk for humans. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e692a57-9d6d-4437-b1bd-f5cbaa3a4312/documents/58b02fdd-54e8-4c75-be5b-36fe4a000f42_04b043d6-b198-4093-be12-5ed644411d7b.html,,,,,, "N,N''-(isobutylidene)diurea",6104-30-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e692a57-9d6d-4437-b1bd-f5cbaa3a4312/documents/58b02fdd-54e8-4c75-be5b-36fe4a000f42_04b043d6-b198-4093-be12-5ed644411d7b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N,N''-(isobutylidene)diurea",6104-30-9," Oral: LD50 > 10000 mg/kg bw (rat, males and females); BASF AG, 1967 Dermal: LD50 > 2000 mg/kg bw (rat, male and female); BASF SE, 2008 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e692a57-9d6d-4437-b1bd-f5cbaa3a4312/documents/30bef8eb-1ea4-4af2-bdfa-d8a1ddb0d24e_04b043d6-b198-4093-be12-5ed644411d7b.html,,,,,, "N,N''-(isobutylidene)diurea",6104-30-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e692a57-9d6d-4437-b1bd-f5cbaa3a4312/documents/30bef8eb-1ea4-4af2-bdfa-d8a1ddb0d24e_04b043d6-b198-4093-be12-5ed644411d7b.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "N,N''-(isobutylidene)diurea",6104-30-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e692a57-9d6d-4437-b1bd-f5cbaa3a4312/documents/30bef8eb-1ea4-4af2-bdfa-d8a1ddb0d24e_04b043d6-b198-4093-be12-5ed644411d7b.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N,N'-(methylenedi-p-phenylene)bis(aziridine-1-carboxamide)",7417-99-4," Key study: Test method OECD 422. GLP study. The NOAEL of the test substance was determined to be 4.3 mg/kg bw/day in a repeated dose toxicity study at doses of 2, 4.3 and 9.5 mg/kg bw/day. Key study: Dose range finding study according to test method OECD 407. DRF nº1: After an oral exposure of the test substance at doses of 50, 100 and 300 mg/kg bw /day for 14 days in males and females rats, treatment related effects including mortalities were found at the lowest level tested. Thus, it was not possible to properly decide on doses for the main study and another dose range finding study was considered to be performed. Key study: Dose range finding study according to test method OECD 407. DRF nº2: The tested dose of 25 mg/kg bw /d was the lowest dose level at which treatment related adverse effects were found in a second DRF perfomed at doses of 2.7, 8.3 and 25 mg/kg bw /day for 14 days in the same conditions as DRF nº1. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39ebb341-deb0-431d-96a7-96c1ed1829fa/documents/f21bff40-0b1a-44eb-a0ab-fb8b8296d319_649464bb-4d44-4efd-8656-6a91a2f24c68.html,,,,,, "N,N'-(methylenedi-p-phenylene)bis(aziridine-1-carboxamide)",7417-99-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39ebb341-deb0-431d-96a7-96c1ed1829fa/documents/f21bff40-0b1a-44eb-a0ab-fb8b8296d319_649464bb-4d44-4efd-8656-6a91a2f24c68.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,4.3 mg/kg bw/day,,rat "N,N'-(methylenedi-p-phenylene)bis(aziridine-1-carboxamide)",7417-99-4," Acute oral toxicity: Key study. Method according to OECD guideline 423, GLP study. The LD50 of the test item is lower than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off may be considered to be 500 mg/kg body weight by oral route in the rat. Acute inhalation toxicity: Data waiving (study scientifically not necessary/other information available): According to REACH Annex VIII, column 2, in addition to the oral route, information from at least other route must be provided depending on the nature of the substance and the likely route of human exposure. Due to the low vapour pressure of the test material the dermal route is the second route of exposure selected. Acute dermal toxicity: Key study. Method according to OECD guideline 402, GLP study. The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39ebb341-deb0-431d-96a7-96c1ed1829fa/documents/c87125ba-9d82-4481-b1b6-1d657e46090a_649464bb-4d44-4efd-8656-6a91a2f24c68.html,,,,,, "N,N'-(methylenedi-p-phenylene)bis(aziridine-1-carboxamide)",7417-99-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39ebb341-deb0-431d-96a7-96c1ed1829fa/documents/c87125ba-9d82-4481-b1b6-1d657e46090a_649464bb-4d44-4efd-8656-6a91a2f24c68.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "N,N'-(methylenedi-p-phenylene)bis(aziridine-1-carboxamide)",7417-99-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39ebb341-deb0-431d-96a7-96c1ed1829fa/documents/c87125ba-9d82-4481-b1b6-1d657e46090a_649464bb-4d44-4efd-8656-6a91a2f24c68.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N'-(methylenedi-p-phenylene)bis[hexahydro-2-oxo-1H-azepine-1-carboxamide]",54112-23-1," According to Regulation (EC) No. 1907/2006, Annex VIII, 8.6.1, column 2, this short-term toxicity study (28 days) does not need to be conducted if a reliable sub-chronic (90 days) study is available. A reliable sub-chronic (90 days) has been performed with the test substance, applying 0 (control), 100, 300 and 1000 mg/kg bw/d per oralis to rats. In lack of any adverse treatment-related effects observed during the treatment period and the recovery period the No Observed Effect Level (NOEL) in this study was set to 1000 mg/kg bw/d (highest dose tested in this study). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb5ff82c-1889-4275-9a14-719af99b9cc5/documents/ebc0af42-bf02-45f8-8241-f4f344ea408b_d93745b3-f4b1-4b33-a980-011472da61c8.html,,,,,, "N,N'-(methylenedi-p-phenylene)bis[hexahydro-2-oxo-1H-azepine-1-carboxamide]",54112-23-1," In two acute toxicity studies (limit test, rat) by oral and inhalation of dust exposure, no mortality was observed. Finding were LC50(rat, inhalation): > 5070 mg/m³; LD50(rat, oral): > 2000 mg/kg bw A study for dermal exposure is not available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb5ff82c-1889-4275-9a14-719af99b9cc5/documents/87888321-9808-4602-82ba-b9b115919281_d93745b3-f4b1-4b33-a980-011472da61c8.html,,,,,, "N,N'-(methylenedi-p-phenylene)bis[hexahydro-2-oxo-1H-azepine-1-carboxamide]",54112-23-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb5ff82c-1889-4275-9a14-719af99b9cc5/documents/87888321-9808-4602-82ba-b9b115919281_d93745b3-f4b1-4b33-a980-011472da61c8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N'-(methylenedi-p-phenylene)bis[hexahydro-2-oxo-1H-azepine-1-carboxamide]",54112-23-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb5ff82c-1889-4275-9a14-719af99b9cc5/documents/87888321-9808-4602-82ba-b9b115919281_d93745b3-f4b1-4b33-a980-011472da61c8.html,,inhalation,LC50,"5,070 mg/m3",no adverse effect observed, "N,N,4-trimethylpiperazine-1-ethylamine",104-19-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83c1d801-d050-4684-953a-e16104363afe/documents/61002ed9-5c12-4535-b42d-e3e659973736_6b06042a-ba2a-4484-b429-5dade96326bd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "N,N,4-trimethylpiperazine-1-ethylamine",104-19-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83c1d801-d050-4684-953a-e16104363afe/documents/74597f0f-15f6-4445-a57b-c2c04e6b8512_6b06042a-ba2a-4484-b429-5dade96326bd.html,,oral,LD50,200 mg/kg bw,adverse effect observed, "N,N,N',N',N'',N''-hexamethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-tripropanamine",15875-13-5," Based on the results of a 90 -day oral gavage study in rats (OECD 408) using the test substance, the No Observed Adverse Effect Level (NOAEL) for general systemic toxicity was 150 mg/kg/day due to the histopathological changes in the stomach. Test-item related changes observed in the non-glandular region of the stomach (epithelial hyperplasia, ulceration, inflammatory cell infiltration or inflammation) and glandular region of the stomach (erosion) in males and females given 500 mg/kg/day for 13 weeks by oral gavage were considered adverse. In the combined Repeat-dose/Reproductive study (OECD 422) the NOAEL (No Observed Adverse Effect Level) for repeated dose toxicity was established as 240 mg/kg body weight/day for males and females.The value was established on the basis of histopathological results in the stomach. The test substance elicited local toxicity effect on the forestomach at 720 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a1f3b82-8674-4077-b21c-9f8fae62f77b/documents/ede91e59-33f6-4ade-aa71-d47ea99bc8a8_092ee68c-5211-4cd4-970d-0f50bc694409.html,,,,,, "N,N,N',N',N'',N''-hexamethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-tripropanamine",15875-13-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9a1f3b82-8674-4077-b21c-9f8fae62f77b/documents/ede91e59-33f6-4ade-aa71-d47ea99bc8a8_092ee68c-5211-4cd4-970d-0f50bc694409.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "N,N,N',N',N'',N''-hexamethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-tripropanamine",15875-13-5,The material is harmful when applied to the skin and is practically non-toxic when administered orally or in vapor form. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a1f3b82-8674-4077-b21c-9f8fae62f77b/documents/382414f8-89b2-4477-a306-940e2a276765_092ee68c-5211-4cd4-970d-0f50bc694409.html,,,,,, "N,N,N',N',N'',N''-hexamethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-tripropanamine",15875-13-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a1f3b82-8674-4077-b21c-9f8fae62f77b/documents/382414f8-89b2-4477-a306-940e2a276765_092ee68c-5211-4cd4-970d-0f50bc694409.html,,oral,LD50,"2,519 mg/kg bw",adverse effect observed, "N,N,N',N',N'',N''-hexamethyl-1,3,5-triazine-1,3,5(2H,4H,6H)-tripropanamine",15875-13-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a1f3b82-8674-4077-b21c-9f8fae62f77b/documents/382414f8-89b2-4477-a306-940e2a276765_092ee68c-5211-4cd4-970d-0f50bc694409.html,,dermal,LD50,"1,566 mg/kg bw",adverse effect observed, "N,N,N',N'-tetrakis(2,3-epoxypropyl)-m-xylene-α,α'-diamine",63738-22-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea3c2b7a-3384-4e48-90ba-0b38e0696b2f/documents/a840f646-13d5-4f20-89a9-53e29c3491ba_71189822-a5ce-4925-b025-4d9f38f7d9ff.html,,oral,LD50,630 mg/kg bw,adverse effect observed, "N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide",57843-53-5,"Under the experimental conditions, the NOAEL of specific target organ toxicity is concluded to be 1000 mg/kg bw/day from 28-day toxicity study in rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ccb3648f-1c9a-4b63-b402-58dfe7fa4f81/documents/288a7cb0-ca96-4c1d-9165-68a191d7cd79_24b69eae-5ca9-45f8-ba48-175df84e85fb.html,,,,,, "N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide",57843-53-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ccb3648f-1c9a-4b63-b402-58dfe7fa4f81/documents/288a7cb0-ca96-4c1d-9165-68a191d7cd79_24b69eae-5ca9-45f8-ba48-175df84e85fb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide",57843-53-5,"LD 50 (oral, rats, 24 h): >2000 mg/kg bw LD 50 (dermal, rabbits, 24 h): >5000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccb3648f-1c9a-4b63-b402-58dfe7fa4f81/documents/1a3ce643-a3e0-46dc-a218-b6585b7d92af_24b69eae-5ca9-45f8-ba48-175df84e85fb.html,,,,,, "N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide",57843-53-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccb3648f-1c9a-4b63-b402-58dfe7fa4f81/documents/1a3ce643-a3e0-46dc-a218-b6585b7d92af_24b69eae-5ca9-45f8-ba48-175df84e85fb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N,N',N'-tetrakis(2-hydroxypropyl)adipamide",57843-53-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccb3648f-1c9a-4b63-b402-58dfe7fa4f81/documents/1a3ce643-a3e0-46dc-a218-b6585b7d92af_24b69eae-5ca9-45f8-ba48-175df84e85fb.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "N,N',N'',N'''-tetrakis(4,6-bis(butyl-(N-methyl-2,2,6,6-tetramethylpiperidin-4-yl)amino)triazin-2-yl)-4,7-diazadecane-1,10-diamine",106990-43-6," The NOEL for subchronic oral exposure of rats is 5 mg/kg bw based on dose-dependent findings especially in the mesenteric lymph nodes, spleen and gastrointestinal tract. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e25a011-e82b-4b00-afbc-c96b9892cc1d/documents/0915f103-91e6-47dc-8280-d140bc695365_b80768d7-d5ae-467e-93e7-65f97ffd235b.html,,,,,, "N,N',N'',N'''-tetrakis(4,6-bis(butyl-(N-methyl-2,2,6,6-tetramethylpiperidin-4-yl)amino)triazin-2-yl)-4,7-diazadecane-1,10-diamine",106990-43-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e25a011-e82b-4b00-afbc-c96b9892cc1d/documents/0915f103-91e6-47dc-8280-d140bc695365_b80768d7-d5ae-467e-93e7-65f97ffd235b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat "N,N',N'',N'''-tetrakis(4,6-bis(butyl-(N-methyl-2,2,6,6-tetramethylpiperidin-4-yl)amino)triazin-2-yl)-4,7-diazadecane-1,10-diamine",106990-43-6," Acute oral toxicity in rat, gavage, LD50 > 5000 mg/kg bw (OECD 401) Acute dermal toxicity in rat, LD50 > 2000 mg/kg bw (OECD 402) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e25a011-e82b-4b00-afbc-c96b9892cc1d/documents/436c7fcc-ef79-4216-854f-de2c26e452b0_b80768d7-d5ae-467e-93e7-65f97ffd235b.html,,,,,, "N,N',N'',N'''-tetrakis(4,6-bis(butyl-(N-methyl-2,2,6,6-tetramethylpiperidin-4-yl)amino)triazin-2-yl)-4,7-diazadecane-1,10-diamine",106990-43-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e25a011-e82b-4b00-afbc-c96b9892cc1d/documents/436c7fcc-ef79-4216-854f-de2c26e452b0_b80768d7-d5ae-467e-93e7-65f97ffd235b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "N,N',N'',N'''-tetrakis(4,6-bis(butyl-(N-methyl-2,2,6,6-tetramethylpiperidin-4-yl)amino)triazin-2-yl)-4,7-diazadecane-1,10-diamine",106990-43-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e25a011-e82b-4b00-afbc-c96b9892cc1d/documents/436c7fcc-ef79-4216-854f-de2c26e452b0_b80768d7-d5ae-467e-93e7-65f97ffd235b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)",3033-62-3," Repeated dose toxicity - oral: A seven day dietary study of low reliability (Klimisch 4) was conducted in rats with doses of 0, 150, 220 and 320 mg/kg bw/day (Carnegie-Mellon, 1975).  No significant effects were associated with the 150 mg/kg/day dose, which was considered the NOEL for systemic toxicity. Repeated dose toxicity - inhalation: A 90 day whole body vapour inhalation study was conducted in rats similar to OECD guidelines with a reliability score of 2 (BRRC, 1993). Doses were 0, 0.22, 1.25 and 5.8 ppm (1.51, 8.2 and 38 mg/m3). There were signs of ocular and respiratory irritation at all doses. The NOAEC for systemic effects is considered to be 1.25 ppm (8.2 mg/m3).  An LOAEC value for local effects of 0.23 ppm (1.51 mg/m3) was determined based on various signs of eye and respiratory tract irritation at all concentrations. Repeated dose toxicity - dermal: A 90 day dermal study was conducted in rabbits according to OECD guideline 411 with a reliability score of 2 (BRRC, 1984). The NOAEL for systemic effects was considered to be greater than the highest tested dose of 8.0 mg/kg bw/day.  All dose levels tested resulted in varying levels of irritation at the exposure site. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1378cff-d97a-4125-890f-83f18b089bef/documents/6d57a2d3-436f-4e07-abd3-97b81d878b09_42f2a7b7-b171-4c9f-bd44-441ec31287ee.html,,,,,, "N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)",3033-62-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1378cff-d97a-4125-890f-83f18b089bef/documents/6d57a2d3-436f-4e07-abd3-97b81d878b09_42f2a7b7-b171-4c9f-bd44-441ec31287ee.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,8 mg/kg bw/day,,rabbit "N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)",3033-62-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1378cff-d97a-4125-890f-83f18b089bef/documents/6d57a2d3-436f-4e07-abd3-97b81d878b09_42f2a7b7-b171-4c9f-bd44-441ec31287ee.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,8.2 mg/m3,,rat "N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)",3033-62-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1378cff-d97a-4125-890f-83f18b089bef/documents/6d57a2d3-436f-4e07-abd3-97b81d878b09_42f2a7b7-b171-4c9f-bd44-441ec31287ee.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1.51 mg/m3,adverse effect observed,rat "N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)",3033-62-3,"Acute toxicity - Oral: A Klimisch 1-rated oral (gavage) acute toxicity study performed in accordance with OECD Guideline 401 reported a LD50 value of 677 mg/kg bw in rats. This study is supported by three other Klimisch 2-rated studies in rats reporting LD50 values ranging from 571 – 1045 mg/kg bw.Acute toxicity - Inhalation: A Klimisch 1 -rated 4 -hr vapour inhalation LC50 study in rats performed in accordance with OECD Guideline 403 reported a LC50 value of > 2.204 mg/L. All animals survived until the scheduled necropsy on Day 15, the exception of one male animal that was found moribund in its housing cage on Test Day 5. This study is supported by three additional Klimisch 2 -rated studies in rats reporting LC50 values of 4 mg/L (4 -hr exposure, aerosol), >3.2 mg/L (3 -hr exposure, vapour) and 1.088 mg/L (6-hr exposure, vapour). Acute toxicity - Dermal: The key study is a well-documented study following methods equivalent to OECD Guideline 402 (Acute Dermal Toxicity). New Zealand White rabbits (5/sex/dose) were exposed dermally under occluded conditions for 24-hours to varying doses of undiluted test substance. The LD50 in males was reported to be 0.373 mL/kg bw and in females was 0.367 mL/kg bw. Using the density of the test substance of 0.848 g/mL (OECD Guideline 109) to convert to mg/kg bw resulted in LD50s of 316 mg/kg bw and 311 mg/kg bw in males and females, respectively. The value used for the CSR was 314 mg/kg bw, the average of the LD50 in males and females. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1378cff-d97a-4125-890f-83f18b089bef/documents/e2aebfbd-7f07-4e68-bfc0-7f33ede7e656_42f2a7b7-b171-4c9f-bd44-441ec31287ee.html,,,,,, "N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)",3033-62-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1378cff-d97a-4125-890f-83f18b089bef/documents/e2aebfbd-7f07-4e68-bfc0-7f33ede7e656_42f2a7b7-b171-4c9f-bd44-441ec31287ee.html,,oral,LD50,677 mg/kg bw,adverse effect observed, "N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)",3033-62-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1378cff-d97a-4125-890f-83f18b089bef/documents/e2aebfbd-7f07-4e68-bfc0-7f33ede7e656_42f2a7b7-b171-4c9f-bd44-441ec31287ee.html,,dermal,LD50,314 mg/kg bw,adverse effect observed, "N,N,N',N'-tetramethyl-2,2'-oxybis(ethylamine)",3033-62-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1378cff-d97a-4125-890f-83f18b089bef/documents/e2aebfbd-7f07-4e68-bfc0-7f33ede7e656_42f2a7b7-b171-4c9f-bd44-441ec31287ee.html,,inhalation,LC50,"2,204 mg/m3",adverse effect observed, "N,N,N',N'-tetramethylethylenediamine",110-18-9," The repeated-dose toxicity of ATMEDAHP (N,N,N’,N’-tetramethylethylenediamine) has been investigated in a combined repeated dose/reproductive/developmental toxicity screening test, conducted according to OECD 422 Test Guideline, reliability 1 and in compliance with GLP (Meijer M, 2018). In the study, Wistar Han rats (10 males and 10 females per dose group) were treated with the test substance once daily by oral gavage (seven days per week for a minimum of 28 days) at dose levels of 0, 30, 100 and 275 mg/kg bw/day.  Based on the findings of the study, and taking into account effects observed in parental rats, the NOAEL for the systemic toxicity of the substance following 28 days of repeated oral exposure was considered to be 100 mg/kg bw, day, based on histological changes in the brain and eyes (females); focal erythema in both ears, and hypersensitivity to touch (females). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70630715-84fe-469b-9d5f-58b7d79deed8/documents/5be9e2af-5049-4e73-84e9-9198abf9237a_b312a3ee-1642-43e4-9033-0d525a32813a.html,,,,,, "N,N,N',N'-tetramethylethylenediamine",110-18-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70630715-84fe-469b-9d5f-58b7d79deed8/documents/5be9e2af-5049-4e73-84e9-9198abf9237a_b312a3ee-1642-43e4-9033-0d525a32813a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "N,N,N',N'-tetramethylethylenediamine",110-18-9, An acute oral toxicity study is available for the submission substance (BULAB 600 / TMEDA). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70630715-84fe-469b-9d5f-58b7d79deed8/documents/8a2e89a6-5102-45bd-b204-56284fcad766_b312a3ee-1642-43e4-9033-0d525a32813a.html,,,,,, "N,N,N',N'-tetramethylethylenediamine",110-18-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70630715-84fe-469b-9d5f-58b7d79deed8/documents/8a2e89a6-5102-45bd-b204-56284fcad766_b312a3ee-1642-43e4-9033-0d525a32813a.html,,oral,LD50,550 mg/kg bw,adverse effect observed, "N,N,N',N'-tetramethylhexamethylenediamine",111-18-2, A modern screening study (OECD 422) and a repeated dose toxicity study (OECD 408) are available to address repeated dose toxicity. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8e25834-9687-46cc-925f-7f23363cbd5c/documents/IUC5-737cc8bb-a95e-4780-aa47-5e6732bf628b_9ee9d54b-f9df-42b9-937f-63ec1b64bafc.html,,,,,, "N,N,N',N'-tetramethylhexamethylenediamine",111-18-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8e25834-9687-46cc-925f-7f23363cbd5c/documents/IUC5-737cc8bb-a95e-4780-aa47-5e6732bf628b_9ee9d54b-f9df-42b9-937f-63ec1b64bafc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,22.5 mg/kg bw/day,,rat "N,N,N',N'-tetramethylhexamethylenediamine",111-18-2," Studies of acute oral, dermal and inhalation toxicity are available. Mortality and toxicity seen in the acute oral and dermal toxicity studies are attributable to local corrosivity. Mortality seen in one acute inhalation toxicity study is also associated with local effects. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8e25834-9687-46cc-925f-7f23363cbd5c/documents/IUC5-8111e527-c2e4-487f-a157-8b367e88f121_9ee9d54b-f9df-42b9-937f-63ec1b64bafc.html,,,,,, "N,N,N',N'-tetramethylhexamethylenediamine",111-18-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8e25834-9687-46cc-925f-7f23363cbd5c/documents/IUC5-8111e527-c2e4-487f-a157-8b367e88f121_9ee9d54b-f9df-42b9-937f-63ec1b64bafc.html,,oral,LD50,238 mg/kg bw,adverse effect observed, "N,N,N',N'-tetramethylhexamethylenediamine",111-18-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8e25834-9687-46cc-925f-7f23363cbd5c/documents/IUC5-8111e527-c2e4-487f-a157-8b367e88f121_9ee9d54b-f9df-42b9-937f-63ec1b64bafc.html,,dermal,discriminating dose,400 mg/kg bw,adverse effect observed, "N,N,N',N'-tetramethylhexamethylenediamine",111-18-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8e25834-9687-46cc-925f-7f23363cbd5c/documents/IUC5-8111e527-c2e4-487f-a157-8b367e88f121_9ee9d54b-f9df-42b9-937f-63ec1b64bafc.html,,inhalation,LC50,410 mg/m3,adverse effect observed, "N,N,N',N'-tetramethyl-N''-[3-(trimethoxysilyl)propyl]guanidine",69709-01-9," In the key acute oral toxicity study, conducted according to a protocol similar to OECD TG 401, but not compliant with GLP, the reported LD50 value for 1,1,3,3-tetramethyl-2-[3-(trimethoxysilyl)propyl]guanidine was 3.67 mL/kg bw, equivalent to 3743 mg/kg bw (Shin-Etsu, 1983). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3d592e1-84a6-472a-b607-392b30c9a2e6/documents/541775ba-022e-4f7d-9ee0-0d86b86caf0b_5aaac4e3-0732-4dfc-869c-8c779ebb56b3.html,,,,,, "N,N,N',N'-tetramethyl-N''-[3-(trimethoxysilyl)propyl]guanidine",69709-01-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3d592e1-84a6-472a-b607-392b30c9a2e6/documents/541775ba-022e-4f7d-9ee0-0d86b86caf0b_5aaac4e3-0732-4dfc-869c-8c779ebb56b3.html,,oral,LD50,"3,743 mg/kg bw",adverse effect observed, "N,N',N''-tributyl-1-methylsilanetriamine",16411-33-9," Based on the available information from the key acute oral toxicity study, the LD50 for N,N',N''-tributyl-1-methyl-silanetriamine was concluded to be between 300 and 2000 mg/kg bw. The study was conducted according to OECD test guideline 423 and to GLP (BSL Bioservice, 2004).   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a95a34be-a99e-4a57-b34d-e1f6f51039ab/documents/aeb51108-af93-4cbb-b4d0-6538ee21bd6f_1ed68b50-dc1b-468a-9b9d-544c1645e073.html,,,,,, "N,N',N''-tributyl-1-methylsilanetriamine",16411-33-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a95a34be-a99e-4a57-b34d-e1f6f51039ab/documents/aeb51108-af93-4cbb-b4d0-6538ee21bd6f_1ed68b50-dc1b-468a-9b9d-544c1645e073.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "N,N,N-tri-C8-C10-alkyl-N-methyl-1-aminium sulfate",2387913-24-6, OECD 422 study (GLP) with rats (administration of the test substance via diet). NOAEL for general systemic toxicity = about 17 mg/kg bw/d (male); about 23 mg/kg bw/d (female). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5bdd57f-4aa2-4437-8469-2b6531a9973a/documents/50aadd67-acae-4dc5-bfd4-5b8dd2fb487e_bf4c9f68-751d-49e8-bb9d-34e8c07f3e86.html,,,,,, "N,N,N-tri-C8-C10-alkyl-N-methyl-1-aminium sulfate",2387913-24-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5bdd57f-4aa2-4437-8469-2b6531a9973a/documents/50aadd67-acae-4dc5-bfd4-5b8dd2fb487e_bf4c9f68-751d-49e8-bb9d-34e8c07f3e86.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat "N,N,N-tri-C8-C10-alkyl-N-methyl-1-aminium sulfate",2387913-24-6," oral: OECD 401, rat LD50 > 200 < 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5bdd57f-4aa2-4437-8469-2b6531a9973a/documents/6c48d125-d962-40a5-83ea-1916444a1f1d_bf4c9f68-751d-49e8-bb9d-34e8c07f3e86.html,,,,,, "N,N,N-tri-C8-C10-alkyl-N-methyl-1-aminium sulfate",2387913-24-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5bdd57f-4aa2-4437-8469-2b6531a9973a/documents/6c48d125-d962-40a5-83ea-1916444a1f1d_bf4c9f68-751d-49e8-bb9d-34e8c07f3e86.html,,oral,LD50,200 mg/kg bw,adverse effect observed, "N,N',N''-tricyclohexyl-1-methylsilanetriamine",15901-40-3," In the key Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening test (Eurofins, 2017) after oral gavage administration in Wistar rats with N,N’,N’’-tricyclohexyl-1-methylsilanetriamine, mortality and effects on food consumption/body weight were observed in the mid and high dose groups due to the corrosive nature of the test material. The NOAEL for repeated dose toxicity was ≥100 mg/kg bw/day (the highest dose tested) for systemic effects and 25 mg/kg bw/day for local effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa108e25-a643-46dd-a831-ec16d440f06f/documents/02993e15-57eb-46eb-b8ea-7aa84d49b131_3cad3613-e2c9-4a81-bebe-6f396d21de2f.html,,,,,, "N,N',N''-tricyclohexyl-1-methylsilanetriamine",15901-40-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa108e25-a643-46dd-a831-ec16d440f06f/documents/02993e15-57eb-46eb-b8ea-7aa84d49b131_3cad3613-e2c9-4a81-bebe-6f396d21de2f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "N,N',N''-tricyclohexyl-1-methylsilanetriamine",15901-40-3," The key acute oral toxicity study for N,N',N''-Tricyclohexyl-1-methylsilanetriamine reports an LD50 of 637 mg/kg bw. It was conducted according to OECD Test Guideline 401 (now deleted) and in compliance with GLP (Hazleton, 1989).   The key acute dermal toxicity study for N,N',N''-tricyclohexyl-1-methylsilanetriamine reports an LD50 of 1594 mg/kg bw. It was conducted according to OECD Test Guideline 402 and in compliance with GLP (Hazleton, 1989). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa108e25-a643-46dd-a831-ec16d440f06f/documents/IUC5-2b9964fa-e273-4f46-a424-7cf74b223ea7_3cad3613-e2c9-4a81-bebe-6f396d21de2f.html,,,,,, "N,N',N''-tricyclohexyl-1-methylsilanetriamine",15901-40-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa108e25-a643-46dd-a831-ec16d440f06f/documents/IUC5-2b9964fa-e273-4f46-a424-7cf74b223ea7_3cad3613-e2c9-4a81-bebe-6f396d21de2f.html,,oral,LD50,637 mg/kg bw,adverse effect observed, "N,N',N''-tricyclohexyl-1-methylsilanetriamine",15901-40-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa108e25-a643-46dd-a831-ec16d440f06f/documents/IUC5-2b9964fa-e273-4f46-a424-7cf74b223ea7_3cad3613-e2c9-4a81-bebe-6f396d21de2f.html,,dermal,LD50,"1,594 mg/kg bw",adverse effect observed, "N,N,N-triethylethanaminium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulfonate",25628-08-4,There are no data available for Tetraethylammonium perfluorobutanesulfonate. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/86cb8c4e-ed8c-4f94-bfa0-f5edac8ab9ac/documents/IUC5-67c55900-4f92-41fb-8136-0527daa55e05_ace37247-e01e-4916-842b-f887d4d24303.html,,,,,, "N,N,N-triethylethanaminium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulfonate",25628-08-4,A valid and guideline conforme oral toxicity study on rats was conducted with tetraethylammonium perfluorobutanesulfonate ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86cb8c4e-ed8c-4f94-bfa0-f5edac8ab9ac/documents/IUC5-04513f5e-831f-48a3-88ee-5f2323368de5_ace37247-e01e-4916-842b-f887d4d24303.html,,,,,, "N,N,N-triethylethanaminium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulfonate",25628-08-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86cb8c4e-ed8c-4f94-bfa0-f5edac8ab9ac/documents/IUC5-04513f5e-831f-48a3-88ee-5f2323368de5_ace37247-e01e-4916-842b-f887d4d24303.html,,oral,discriminating dose,"2,000 mg/kg bw",, "N,N,N-trimethylanilinium chloride",138-24-9," Repeated dose toxicity: via oral route; No Observed Adverse Effect Level (NOAEL) is considered to be in a dose range of  1000 - 735 mg  / kg body weight/day when male and female rats were orally treated with test chemical. Repeated inhalation study: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance N,N,N-trimethylanilinium chloride ( 138-24-9)  which is reported as 4.687886e-8 mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical N,N,N-trimethylanilinium chloride is highly unlikely. Therefore this study is considered for waiver. Repeated dermal study; The acute toxicity value for N,N,N-trimethylanilinium chloride ( 138-24-9) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that N,N,N-trimethylanilinium chloride shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that N,N,N-trimethylanilinium chloride shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cea54eb-9a2d-42b9-8b7a-9849fd21025d/documents/a8c72688-65de-4558-885c-ea2aa8e47e5a_b6e9f0dd-f852-4c4d-bd8a-76262e28d7b6.html,,,,,, "N,N,N-trimethylanilinium chloride",138-24-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cea54eb-9a2d-42b9-8b7a-9849fd21025d/documents/a8c72688-65de-4558-885c-ea2aa8e47e5a_b6e9f0dd-f852-4c4d-bd8a-76262e28d7b6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N,N,N-trimethylanilinium chloride",138-24-9," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is between 50 - 300 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 3” for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity dose (LC50) was considered based on different studies conducted on rats for the test chemical. The LC50 value considered to be 1300 mg/m3. The study concluded that LC50 is between 1 to ≤ 5 mg/L, for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute inhalation toxicity. Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cea54eb-9a2d-42b9-8b7a-9849fd21025d/documents/457748d7-2349-48a9-995c-70667932fc60_b6e9f0dd-f852-4c4d-bd8a-76262e28d7b6.html,,,,,, "N,N,N-trimethylanilinium chloride",138-24-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cea54eb-9a2d-42b9-8b7a-9849fd21025d/documents/457748d7-2349-48a9-995c-70667932fc60_b6e9f0dd-f852-4c4d-bd8a-76262e28d7b6.html,,oral,LD50,200 mg/kg bw,adverse effect observed, "N,N,N-trimethylanilinium chloride",138-24-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cea54eb-9a2d-42b9-8b7a-9849fd21025d/documents/457748d7-2349-48a9-995c-70667932fc60_b6e9f0dd-f852-4c4d-bd8a-76262e28d7b6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N,N-trimethylanilinium chloride",138-24-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cea54eb-9a2d-42b9-8b7a-9849fd21025d/documents/457748d7-2349-48a9-995c-70667932fc60_b6e9f0dd-f852-4c4d-bd8a-76262e28d7b6.html,,inhalation,LC50,"1,300 mg/m3",adverse effect observed, "N,N'-[(methylimino)bis(trimethylene)]bis(stearamide)",13483-58-4,"A NOAEL for systemic toxicity of 1000 mg/kg bw/day was established for N,N’[(methylimino)bis(trimethylene)]bis(stearamide) based on information from an OECD 422 GLP guideline study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/084adeda-d4c6-4bdc-85e6-4abd971366f8/documents/f7163169-56ad-4c93-864d-de4c2ab85968_5698a58d-1915-4153-944b-a19ffaf1d67e.html,,,,,, "N,N'-[(methylimino)bis(trimethylene)]bis(stearamide)",13483-58-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/084adeda-d4c6-4bdc-85e6-4abd971366f8/documents/f7163169-56ad-4c93-864d-de4c2ab85968_5698a58d-1915-4153-944b-a19ffaf1d67e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N,N'-[(methylimino)bis(trimethylene)]bis(stearamide)",13483-58-4,"For acute oral toxicity a LD50value of > 2000 mg/kg was established for N,N’[(methylimino)bis(trimethylene)]bis(stearamide). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/084adeda-d4c6-4bdc-85e6-4abd971366f8/documents/ced08dce-70f5-43f9-b350-7b7ea1ac6e3a_5698a58d-1915-4153-944b-a19ffaf1d67e.html,,,,,, "N,N'-[(methylimino)bis(trimethylene)]bis(stearamide)",13483-58-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/084adeda-d4c6-4bdc-85e6-4abd971366f8/documents/ced08dce-70f5-43f9-b350-7b7ea1ac6e3a_5698a58d-1915-4153-944b-a19ffaf1d67e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N'-[(methylimino)dipropane-1,3-diyl]dioleamide",45320-65-8," A NOAEL for systemic toxicity of 1000 mg/kg bw/day was established for N, N’-[(methylimino)bis(trimethylene)] bis(oleamide) based on read-across information from an OECD 422 guideline study with the test substance N,N’[(methylimino)bis(trimethylene)]bis(stearamide). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ada66b88-85b1-4a64-a5d9-142f1ff7f0af/documents/84ec4718-a1fe-4ef1-a7dd-f36d5830fb22_b27beb11-6504-4b1a-a815-37a1942a262a.html,,,,,, "N,N'-[(methylimino)dipropane-1,3-diyl]dioleamide",45320-65-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ada66b88-85b1-4a64-a5d9-142f1ff7f0af/documents/84ec4718-a1fe-4ef1-a7dd-f36d5830fb22_b27beb11-6504-4b1a-a815-37a1942a262a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N,N'-[(methylimino)dipropane-1,3-diyl]dioleamide",45320-65-8," A LD50 value of > 2000 mg/kg can be established for N, N’-[(methylimino)bis (trimethylene)]bis(oleamide). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ada66b88-85b1-4a64-a5d9-142f1ff7f0af/documents/408e53d0-069d-4fbb-b869-2f834151a006_b27beb11-6504-4b1a-a815-37a1942a262a.html,,,,,, "N,N'-[(methylimino)dipropane-1,3-diyl]dioleamide",45320-65-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ada66b88-85b1-4a64-a5d9-142f1ff7f0af/documents/408e53d0-069d-4fbb-b869-2f834151a006_b27beb11-6504-4b1a-a815-37a1942a262a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N'-[6,13-diacetamido-2,9-diethoxy-3,10-triphenodioxazinediyl]bis(benzamide)",17741-63-8," OECD 422; GLP, Wistar rats; 100, 300, and 1000 mg/kg bw/day; males and females were exposed for 29 and 42 -56 days, respectively; no adverse effects observed; NOAEL 1000 mg/kg bw/kg ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dafbe4c5-6d5f-493d-a097-c95600d40e6f/documents/a238d5bc-2e08-4b84-9923-6f42c52bd82c_8b8128df-65cc-459e-baf8-78ae1985e219.html,,,,,, "N,N'-[6,13-diacetamido-2,9-diethoxy-3,10-triphenodioxazinediyl]bis(benzamide)",17741-63-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dafbe4c5-6d5f-493d-a097-c95600d40e6f/documents/a238d5bc-2e08-4b84-9923-6f42c52bd82c_8b8128df-65cc-459e-baf8-78ae1985e219.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N,N'-[6,13-diacetamido-2,9-diethoxy-3,10-triphenodioxazinediyl]bis(benzamide)",17741-63-8,"Several acute oral toxicity studies were performed, resulting in LD50 values of >5000 and >15000 mg/kg bw. In an acute dermal toxicity study (OECD guideline 402, GLP) no mortality occured and no signs of toxicity were observed. LD50 dermal is considered to be > 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dafbe4c5-6d5f-493d-a097-c95600d40e6f/documents/757aaf30-d1b2-46cd-b0da-04692bc80cc0_8b8128df-65cc-459e-baf8-78ae1985e219.html,,,,,, "N,N'-[6,13-diacetamido-2,9-diethoxy-3,10-triphenodioxazinediyl]bis(benzamide)",17741-63-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dafbe4c5-6d5f-493d-a097-c95600d40e6f/documents/757aaf30-d1b2-46cd-b0da-04692bc80cc0_8b8128df-65cc-459e-baf8-78ae1985e219.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "N,N'-[6,13-diacetamido-2,9-diethoxy-3,10-triphenodioxazinediyl]bis(benzamide)",17741-63-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dafbe4c5-6d5f-493d-a097-c95600d40e6f/documents/757aaf30-d1b2-46cd-b0da-04692bc80cc0_8b8128df-65cc-459e-baf8-78ae1985e219.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N’-di[3-(p-toluene sulfonyl)oxy]phenyl urea",2292123-68-1,"The substance has been tested for sub-chronic repeated dose toxicity in rats. In a 90-day repeated dose toxicity study conducted in accordance with OECD Guideline 408, the NOAEL was reported as 1000 mg/kg/day (nominal).  No treatment-related effects were observed at any dose level during the study. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study was part of a testing package where all the studies have been conducted under GLP and in accordance with OECD guidelines or national methods, where applicable. The quality of data has been assessed to be reliable. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9cd624b-d794-4462-aa10-1dd70a5c0873/documents/40c87672-704d-45db-82e4-369b7e19a8e0_b5fa9fa3-a175-40f5-a6e4-95c46793bce5.html,,,,,, "N,N’-di[3-(p-toluene sulfonyl)oxy]phenyl urea",2292123-68-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9cd624b-d794-4462-aa10-1dd70a5c0873/documents/40c87672-704d-45db-82e4-369b7e19a8e0_b5fa9fa3-a175-40f5-a6e4-95c46793bce5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N,N’-di[3-(p-toluene sulfonyl)oxy]phenyl urea",2292123-68-1,"The substance has been tested for acute toxicity via the oral and inhalation routes. In an acute oral toxicity study conducted in accordance with OECD Guideline 420, the LD50 was reported as >2000 mg/kg (nominal).  No mortality or treatment-related effects were observed during the study. In an inhalation toxicity study conducted in accordance with OECD Guideline 403, the 4h LC50 was reported as >1.819 mg/L air (Maximum Achievable Breathing Zone Concentration) equivalent to 34.052 mg/L air (nominal). No mortality or adverse toxic effects were observed during the study.     Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study was part of a testing package where all the studies have been conducted under GLP and in accordance with OECD guidelines or national methods, where applicable. The quality of data has been assessed to be reliable. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The study was part of a testing package where all the studies have been conducted under GLP and in accordance with OECD guidelines or national methods, where applicable. The quality of data has been assessed to be reliable. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9cd624b-d794-4462-aa10-1dd70a5c0873/documents/c61ba066-16bb-4ba2-bce8-2ad95091695b_b5fa9fa3-a175-40f5-a6e4-95c46793bce5.html,,,,,, "N,N’-di[3-(p-toluene sulfonyl)oxy]phenyl urea",2292123-68-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9cd624b-d794-4462-aa10-1dd70a5c0873/documents/c61ba066-16bb-4ba2-bce8-2ad95091695b_b5fa9fa3-a175-40f5-a6e4-95c46793bce5.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "N,N’-di[3-(p-toluene sulfonyl)oxy]phenyl urea",2292123-68-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9cd624b-d794-4462-aa10-1dd70a5c0873/documents/c61ba066-16bb-4ba2-bce8-2ad95091695b_b5fa9fa3-a175-40f5-a6e4-95c46793bce5.html,,inhalation,LC50,> 1.819 mg/L,no adverse effect observed, "N,N'''-1,6-hexanediylbis[N'-cyanoguanidine]",15894-70-9,In a 28 day subacute oral study in the rat there were no effects of toxicological significance. The NOEL is 1000 mg/kg bw/day.   ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/356d01b9-3a5d-47e9-8011-50afa34ccb8b/documents/IUC5-ba4d40ae-d09d-4292-bb7e-424e8501550c_26974766-90a8-40cd-864a-4e3795876a45.html,,,,,, "N,N'''-1,6-hexanediylbis[N'-cyanoguanidine]",15894-70-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/356d01b9-3a5d-47e9-8011-50afa34ccb8b/documents/IUC5-ba4d40ae-d09d-4292-bb7e-424e8501550c_26974766-90a8-40cd-864a-4e3795876a45.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N,N'''-1,6-hexanediylbis[N'-cyanoguanidine]",15894-70-9,HMBDA is of low acute toxicity in mammals by both the oral and dermal routes.   ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/356d01b9-3a5d-47e9-8011-50afa34ccb8b/documents/IUC5-7ae99913-bcd6-4132-9de5-8b45575244b0_26974766-90a8-40cd-864a-4e3795876a45.html,,,,,, "N,N'''-1,6-hexanediylbis[N'-cyanoguanidine]",15894-70-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/356d01b9-3a5d-47e9-8011-50afa34ccb8b/documents/IUC5-7ae99913-bcd6-4132-9de5-8b45575244b0_26974766-90a8-40cd-864a-4e3795876a45.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N'''-1,6-hexanediylbis[N'-cyanoguanidine]",15894-70-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/356d01b9-3a5d-47e9-8011-50afa34ccb8b/documents/IUC5-7ae99913-bcd6-4132-9de5-8b45575244b0_26974766-90a8-40cd-864a-4e3795876a45.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N'-bis(1,4-dimethylpentyl)-p-phenylenediamine",3081-14-9,"Several oral repeated dose toxicity studies were conducted to evaluate the toxicity of the test substance 77PD. In a subacute feeding study with rats (Monsanto Co. 1989) effects on body weight and body weight gain was noted in treated animals. In addition, increases in mean platelet counts and mean erythrocyte counts and alterations in several clinical chemistry parameters were noted in animals of the higher dose groups. In a subchronic feeding study with rats (Monsanto Co. 1989) decreases in body weight and body weight gain were noted in treated animals. Moreover, changes in clinical chemistry were noted in treated animals. In an early two-year chronic feeding study (Monsanto Co. 1978) slight reductions of body weight and body weight gain were noted in treated animals. Because of the limitations of the early chronic feeding study, which is used only as supporting study, the subchronic feeding study is considered to be the most relevant study for hazard assessment. Based on the findings of this study, the suggested LOAEL of 250 ppm (15.9 mg/kg bw/day) is used for DNEL calculation, taking also into consideration the NOAEL from the chronic study of 100 ppm. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76a82813-121c-4da8-b3fb-798739ca1bb9/documents/IUC5-e3e59de9-63bc-4577-a89d-96a0649a404a_36a82feb-def7-4f63-afef-b67614da0324.html,,,,,, "N,N'-bis(1,4-dimethylpentyl)-p-phenylenediamine",3081-14-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76a82813-121c-4da8-b3fb-798739ca1bb9/documents/IUC5-e3e59de9-63bc-4577-a89d-96a0649a404a_36a82feb-def7-4f63-afef-b67614da0324.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,15.9 mg/kg bw/day,,rat "N,N'-bis(1,4-dimethylpentyl)-p-phenylenediamine",3081-14-9,"The acute oral toxicity of 77PD is moderate, indicated by an oral LD50 value of 730 mg/kg bw in Sprague-Dawley rats (Monsanto Co. 1973); based on this finding 77PD should be classified as harmful if swallowed.The acute dermal toxicity of 77PD is low, indicated by a dermal LD50 value of > 3160 mg/kg bw in rabbits after single application (Monsanto Co. 1973). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76a82813-121c-4da8-b3fb-798739ca1bb9/documents/IUC5-c4aed3ce-db2a-4f2e-9b0d-4ee15afccad5_36a82feb-def7-4f63-afef-b67614da0324.html,,,,,, "N,N'-bis(1,4-dimethylpentyl)-p-phenylenediamine",3081-14-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76a82813-121c-4da8-b3fb-798739ca1bb9/documents/IUC5-c4aed3ce-db2a-4f2e-9b0d-4ee15afccad5_36a82feb-def7-4f63-afef-b67614da0324.html,,oral,LD50,730 mg/kg bw,, "N,N'-bis(1,4-dimethylpentyl)-p-phenylenediamine",3081-14-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76a82813-121c-4da8-b3fb-798739ca1bb9/documents/IUC5-c4aed3ce-db2a-4f2e-9b0d-4ee15afccad5_36a82feb-def7-4f63-afef-b67614da0324.html,,dermal,LD50,"3,160 mg/kg bw",, "N,N-bis(1-methylethyl)formamide",2700-30-3,"Refer to the OECD Guideline 407, a repeated Dose 28-Day Oral Toxicity Study in Sprague Dawley rats with DIPF was performed. The no-adverse-observed-effect-level (NOAEL) for DIPF in the repeated dose 28-day oral toxicity study in SD rats under the condition of the study was considered to be 30 mg/kg bw/day for males and 50 mg/kg bw/day for females. The lowest-observed-adverse-effect level (LOAEL) was considered to be 100 mg/kg bw/day for males. The treatment-related effects were as followed: In the 100 mg/kg bw/day, male rats showed toxic effects in the nerve functional observations that were home-cage, open-field and autonomic motor function and female rats mortality increased. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c155ab82-5c47-4194-84dc-49df86ceba36/documents/5df6400a-96d3-4d2c-bb19-e0b49a1e44f8_c60e6692-19b8-4376-a5ec-6213310f2c03.html,,,,,, "N,N-bis(1-methylethyl)formamide",2700-30-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c155ab82-5c47-4194-84dc-49df86ceba36/documents/5df6400a-96d3-4d2c-bb19-e0b49a1e44f8_c60e6692-19b8-4376-a5ec-6213310f2c03.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "N,N-bis(1-methylethyl)formamide",2700-30-3,The acute oral LD50 in rats for the test item was estimated to be between 300 and 50 mg/kg b.w. and the cut-off value of LD50 was estimated to be 200 mg/kg b.w. The acute dermal LD50 in rats for DIPF was estimated to be more than 2000 mg/kg b.w. and less than 5000 mg/kg b.w. in female SD rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c155ab82-5c47-4194-84dc-49df86ceba36/documents/6973257c-bcf4-4878-9cee-8c45b133e559_c60e6692-19b8-4376-a5ec-6213310f2c03.html,,,,,, "N,N-bis(1-methylethyl)formamide",2700-30-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c155ab82-5c47-4194-84dc-49df86ceba36/documents/6973257c-bcf4-4878-9cee-8c45b133e559_c60e6692-19b8-4376-a5ec-6213310f2c03.html,,oral,LD50,> 50 mg/kg bw,adverse effect observed, "N,N-bis(1-methylethyl)formamide",2700-30-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c155ab82-5c47-4194-84dc-49df86ceba36/documents/6973257c-bcf4-4878-9cee-8c45b133e559_c60e6692-19b8-4376-a5ec-6213310f2c03.html,,dermal,LD50,"> 2,000 mg/kg bw",adverse effect observed, "N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine",61260-55-7,Oral: NOAEL (rat) - systemic: 275 mg/kg bw/dayOral: NOAEL (rat) - local: 44 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69f8236d-30cb-4008-9157-f0a527dd2470/documents/IUC5-bb328210-3653-4ee7-aba5-23ce54f7a465_b59d2c30-7a35-475c-9d8d-392f15edee2b.html,,,,,, "N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine",61260-55-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/69f8236d-30cb-4008-9157-f0a527dd2470/documents/IUC5-bb328210-3653-4ee7-aba5-23ce54f7a465_b59d2c30-7a35-475c-9d8d-392f15edee2b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,275 mg/kg bw/day,,rat "N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine",61260-55-7,Oral: LD50 (rat) = 820 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69f8236d-30cb-4008-9157-f0a527dd2470/documents/IUC5-11020784-c715-43af-a65b-536d91f07de9_b59d2c30-7a35-475c-9d8d-392f15edee2b.html,,,,,, "N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)hexane-1,6-diamine",61260-55-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/69f8236d-30cb-4008-9157-f0a527dd2470/documents/IUC5-11020784-c715-43af-a65b-536d91f07de9_b59d2c30-7a35-475c-9d8d-392f15edee2b.html,,oral,LD50,820 mg/kg bw,adverse effect observed, "N,N-bis(2-hydroxyethyl)undec-10-enamide",60239-68-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0486cc2-a06b-4fa9-8073-de100ad9d104/documents/2fbbaabf-ebd3-4474-91ad-7db47737597d_eaffd64d-092a-4c1d-b40c-50af0231ff11.html,,oral,LD50,"2,700 mg/kg bw",no adverse effect observed, "N,N-bis(2-methylpropyl)formamide",2591-76-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d858a6a-c5be-47ea-97bb-9b8a78e8ef9d/documents/IUC5-fcecbc60-65ca-4546-9331-04372ca872ad_4ffa78f7-d76e-49cf-b887-2766dc332517.html,,oral,LD50,464 mg/kg bw,adverse effect observed, "N,N'-bis(3-aminopropyl)ethylenediamine",10563-26-5,"A reliable combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test of N4 -Amine in rats by oral gavage (GLP, OECD 422) is available (BASF 2013). The test substance was administered by daily oral gavage to male and female Wistar Han rats at dose levels of 30, 100 and 300 mg/kg bw/day. Treatment with the test substance by oral gavage in male and female Wistar Han rats at dose levels of 30, 100 and 300 mg/kg body weight/day revealed parental toxicity at 100 and 300 mg/kg bw/day. Based on these results, a parental NOAEL of 30 mg/kg bw/day was established.  On the basis of a 90-day repeated dose oral toxicity study with the test material in male and female Wistar rats with dose levels of 50/30/15, 150/100/30 and 450/300/220/150/60 mg/kg body weight day the following conclusions can be made:Under the conditions of this study, the NOAEL for systemic toxicity after 90-days exposure could be established at 30 mg/kg bw/day in Wistar rats with the test item N,N’-bis(3-aminopropyl)ethylenediamine (BSL, 2023).   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6fd9adf-c3e4-49e3-a73d-809886970468/documents/ea647d28-e3bb-426f-bade-d4f1d851f155_7203da97-22ba-4d54-8411-484fe44b30f2.html,,,,,, "N,N'-bis(3-aminopropyl)ethylenediamine",10563-26-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6fd9adf-c3e4-49e3-a73d-809886970468/documents/ea647d28-e3bb-426f-bade-d4f1d851f155_7203da97-22ba-4d54-8411-484fe44b30f2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "N,N'-bis(3-aminopropyl)ethylenediamine",10563-26-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6fd9adf-c3e4-49e3-a73d-809886970468/documents/ea647d28-e3bb-426f-bade-d4f1d851f155_7203da97-22ba-4d54-8411-484fe44b30f2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "N,N'-bis(3-aminopropyl)ethylenediamine",10563-26-5,"Acute oral: 950 mg/kg bw < LD 50< 1397 mg/kg bw (Similar to OECD TG 401; BASF SE, 1977)Acute dermal: LD 50 > 200 mg/kg bw (OECD 402; Air Products & Chemicals Inc, 2007) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6fd9adf-c3e4-49e3-a73d-809886970468/documents/667fbea3-9c50-4dcb-a24d-0084d9fe2804_7203da97-22ba-4d54-8411-484fe44b30f2.html,,,,,, "N,N'-bis(3-aminopropyl)ethylenediamine",10563-26-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6fd9adf-c3e4-49e3-a73d-809886970468/documents/667fbea3-9c50-4dcb-a24d-0084d9fe2804_7203da97-22ba-4d54-8411-484fe44b30f2.html,,oral,LD50,"1,140 mg/kg bw",adverse effect observed, "N,N'-bis(3-aminopropyl)ethylenediamine",10563-26-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6fd9adf-c3e4-49e3-a73d-809886970468/documents/667fbea3-9c50-4dcb-a24d-0084d9fe2804_7203da97-22ba-4d54-8411-484fe44b30f2.html,,dermal,discriminating dose,200 mg/kg bw,adverse effect observed, "N,N'-bis(3-aminopropyl)propane-1,3-diamine",4605-14-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Scientifically acceptable study report, comparable to guideline with acceptable restrictions (mostly due to reduced reporting in times before GLP). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): orientating information of inhalation toxicity; inhalation exposure duration: 8 hours; extrapolation of an exact LD50 (4h) is not possible ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc8c495c-164a-47e0-9592-60c46102246c/documents/0595e249-da64-4272-a316-b1a799a0c451_1363591f-a465-4e15-93c0-8c764e85f913.html,,,,,, "N,N'-bis(3-aminopropyl)propane-1,3-diamine",4605-14-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc8c495c-164a-47e0-9592-60c46102246c/documents/0595e249-da64-4272-a316-b1a799a0c451_1363591f-a465-4e15-93c0-8c764e85f913.html,,oral,LD50,736 mg/kg bw,adverse effect observed, "N,N-Bis-(4-biphenyl)amine",102113-98-4, OECD 423: LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ad94acb-26cb-42f7-ae1b-d9e55fb282c5/documents/035a4947-e1b0-4fac-ba80-fa1bdd8c56b7_4092e1cd-7887-45c2-93f2-3847004950e7.html,,,,,, "N,N-Bis-(4-biphenyl)amine",102113-98-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ad94acb-26cb-42f7-ae1b-d9e55fb282c5/documents/035a4947-e1b0-4fac-ba80-fa1bdd8c56b7_4092e1cd-7887-45c2-93f2-3847004950e7.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N,N'-bis(5,5-dimethyl-1,3,2-dioxaphosphinane-2-oxide-2-yl)ethane-1,2-diamine",256374-76-2,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyInformation.KeyInformation): Repeated dose toxicity: oral - 90 day No-Observed-Adverse-Effect Level (NOAEL) of EC 835-272-7 was considered to be 1000 mg/kg bw/day.   Repeated dose toxicity: oral - 28 day No Observed Adverse Effect Level (NOAEL) of EC 835-272-7 is 1000 mg/kg/day since no toxic effect was observed in any treated groups up to the high dose of 1000 mg/kg/day. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): K1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d08a66a5-85e9-499e-9e4e-40d5f69c148f/documents/d49c9f78-7671-4b95-b20e-080748fa2c96_f80e3b51-91ee-41d9-b458-b2403bd2c152.html,,,,,, "N,N'-bis(5,5-dimethyl-1,3,2-dioxaphosphinane-2-oxide-2-yl)ethane-1,2-diamine",256374-76-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d08a66a5-85e9-499e-9e4e-40d5f69c148f/documents/d49c9f78-7671-4b95-b20e-080748fa2c96_f80e3b51-91ee-41d9-b458-b2403bd2c152.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N,N'-bis(5,5-dimethyl-1,3,2-dioxaphosphinane-2-oxide-2-yl)ethane-1,2-diamine",256374-76-2,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyInformation.KeyInformation): Acute toxicity: oral LD50 value of EC 835-272-7 was found to be above 2000 mg/kg bw in female RccHan:WIST rats.   Acute toxicity: inhalation 4hr LC50 of EC 835-272-7, in CRL: (WI) Wistar strain rats, was therefore considered to be greater than 5.07 mg/L.   Acute toxicity: dermal LD50 of EC 835-272-7 after a single dermal administration was found to be greater than 2000 mg/kg bw in male and female Crl:WI rats. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): K1Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): K1Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): K1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d08a66a5-85e9-499e-9e4e-40d5f69c148f/documents/0b1875e4-f428-4b15-9841-677d14e9493a_f80e3b51-91ee-41d9-b458-b2403bd2c152.html,,,,,, "N,N'-bis(5,5-dimethyl-1,3,2-dioxaphosphinane-2-oxide-2-yl)ethane-1,2-diamine",256374-76-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d08a66a5-85e9-499e-9e4e-40d5f69c148f/documents/0b1875e4-f428-4b15-9841-677d14e9493a_f80e3b51-91ee-41d9-b458-b2403bd2c152.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N'-bis(5,5-dimethyl-1,3,2-dioxaphosphinane-2-oxide-2-yl)ethane-1,2-diamine",256374-76-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d08a66a5-85e9-499e-9e4e-40d5f69c148f/documents/0b1875e4-f428-4b15-9841-677d14e9493a_f80e3b51-91ee-41d9-b458-b2403bd2c152.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N'-bis(5,5-dimethyl-1,3,2-dioxaphosphinane-2-oxide-2-yl)ethane-1,2-diamine",256374-76-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d08a66a5-85e9-499e-9e4e-40d5f69c148f/documents/0b1875e4-f428-4b15-9841-677d14e9493a_f80e3b51-91ee-41d9-b458-b2403bd2c152.html,,inhalation,LC50,"5,070 mg/m3",no adverse effect observed, "N,N-bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3)",94134-01-7," An assessment was undertaken based on available data on the individual constituents of the substance. A NOAEL of 175 mg/kg bw/d is proposed for the short-term repeated-dose toxicity of N,N’-bis(carboxymethylglycine) compound with 2-aminoethanol (1:3) via the oral route. This value is considered as conservative. The substance does not induce specific target organ toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efbb2f49-68ac-4486-90e6-b8c3a544bb6b/documents/eb2963d1-88d5-47f0-987f-7307a6713503_185e98cf-9a77-41a8-9c18-d54b813e6641.html,,,,,, "N,N-bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3)",94134-01-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efbb2f49-68ac-4486-90e6-b8c3a544bb6b/documents/eb2963d1-88d5-47f0-987f-7307a6713503_185e98cf-9a77-41a8-9c18-d54b813e6641.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,175 mg/kg bw/day,,rat "N,N-bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3)",94134-01-7," An experiment was performed to assess the acute oral toxicity of N, N’- bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3), in accordance with the OECD Testing Guideline 420. The study was GLP-compliant. Fasted female rats received a single oral gavage dose of the test item, formulated in purified water. Sighting investigations found no morbidities at 300 and 2000 mg/kg, based on these results a further four fasted females were dosed at 2000 mg/kg in the main study. Due to the number of deaths in the main study at 2000 mg/kg body weight, a further four fasted females were similarly dosed at 300 mg/kg body weight to complete the study. During the study, clinical condition, body weight and macropathology investigations were undertaken. Two female animals treated at 2,000 mg/kg bw died as a result of the exposure to the test substance. Clinical signs at this dose level included underactivity, chin rubbing, unsteady gait, repetitive movements, tremors and both eyelids partially closed. At 300 mg/kg bw, there was no death and no clinical signs were observed. In accordance with the flow chart associated to the OECD TG 420, the LD50 of N,N’-bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3) shall be considered as to be between 300 and 2,000 mg/kg body weight. Exposure of humans via the inhalation or dermal routes is not likely taking into account their physicohemical properties and use, therefore it was not considered scienfitically justified to investigate the acute toxicity of the registered substance via these routes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efbb2f49-68ac-4486-90e6-b8c3a544bb6b/documents/48ee6166-0cec-4fd6-8b86-837f2bd82919_185e98cf-9a77-41a8-9c18-d54b813e6641.html,,,,,, "N,N-bis(carboxymethyl)glycine, compound with 2-aminoethanol (1:3)",94134-01-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efbb2f49-68ac-4486-90e6-b8c3a544bb6b/documents/48ee6166-0cec-4fd6-8b86-837f2bd82919_185e98cf-9a77-41a8-9c18-d54b813e6641.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "N,N-bis(carboxymethyl)-L-glutamic acid",58976-65-1,The No Observed Adverse Effect Level (NOAEL) for GLDA-Na4 in a 90-day oral gavage study in rats was established to be 300 mg/kg bw/day.   ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0fd03167-fc0d-4a8e-909f-1ea2823447c4/documents/IUC5-40dccd3e-04b6-48c4-a1de-14a2167904cd_77b96ed7-83f0-43d2-9396-4b3a8c2f0d60.html,,,,,, "N,N-bis(carboxymethyl)-L-glutamic acid",58976-65-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0fd03167-fc0d-4a8e-909f-1ea2823447c4/documents/IUC5-40dccd3e-04b6-48c4-a1de-14a2167904cd_77b96ed7-83f0-43d2-9396-4b3a8c2f0d60.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "N,N-bis(carboxymethyl)-L-glutamic acid",58976-65-1,"GLDA-Na4 and GLDA-H4 are considered not to have significant acute oral, dermal and respiratory toxicity (see further at Discussion).   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fd03167-fc0d-4a8e-909f-1ea2823447c4/documents/IUC5-89ed9b7b-6d33-436d-ba51-0598a396df07_77b96ed7-83f0-43d2-9396-4b3a8c2f0d60.html,,,,,, "N,N'-bis[2-hydroxy-3-(2,2,3,3-tetrafluoropropoxy)propyl]-N,N,N',N'-tetramethylethane-1,2-diaminium dichloride",1220100-43-5,"Based upon the combined weight of evidence of the in vitro basal cytotoxicity test using Neutral Red Uptake in Balb/c 3T3 mouse fibroblasts, the substance is considered to have a low order of acute oral toxicity, when it is considered the in vitro study indicates an estimated rodent oral LD50 of 8840 mg/kg and during the 7 day repeated dose study it was found that all animals survived to the 7 day point at the highest dose of 1320 mg/kg/bw. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b95c415-31c3-414d-9781-aff216534369/documents/IUC5-e6c3e507-8b6a-4463-9626-741f3560a754_8d6f297b-6af6-4c02-bcf2-9e12a331ffa6.html,,,,,, "N,N-bis[3-(dimethylamino)propyl]-N',N'-dimethylpropane-1,3-diamine",33329-35-0,"Based on on the available subacute and subchronic repeated dose toxicity studies resulted in NOAELs of 200 mg/kg bw/day or greater. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The results of this study strongly indicates that the corrosive effects are the cause of all observed effects. Only animals in the high-dose group showed significant effects, and these are consistent with the animals being dosed with a corrosive. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd062f93-f026-4dbf-8ea9-b4a35ac79828/documents/IUC5-d6c0c0c9-e3ee-41ae-b095-53cbb1f5f85a_72e4bcdc-6707-4dd9-989a-51c9692ab61e.html,,,,,, "N,N-bis[3-(dimethylamino)propyl]-N',N'-dimethylpropane-1,3-diamine",33329-35-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd062f93-f026-4dbf-8ea9-b4a35ac79828/documents/IUC5-d6c0c0c9-e3ee-41ae-b095-53cbb1f5f85a_72e4bcdc-6707-4dd9-989a-51c9692ab61e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "N,N-bis[3-(dimethylamino)propyl]-N',N'-dimethylpropane-1,3-diamine",33329-35-0,"The substance is severely irritating and corrosive to the skin, eyes and respiratory tract.No thresholds are definable for the corrosive/irritant effects. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The substance is severely irritating and corrosive to the skin, eyes and respiratory tract. Limited conclusions regarding systemic toxicity are possible due to the corrosive effects observed in animals (forestomach corrosion, low urinary pH, clinical indications). Rat - Acute Oral LD50 = 2385 mg/kg Mouse - Acute Oral LD50 = 2597 mg/kg Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The substance is severely irritating and corrosive to the skin, eyes and respiratory tract. At necropsy red lungs were observed in a few animals from each group. Scattered red patches on the lungs were also observed in a few animals from each group with the exception of Group 111, where the lesion was not observed. Black patches in the thymus was observed in three males and three females during the necropsy. Limited conclusions regarding systemic toxicity are possible due to the corrosive effects observed in animals (lung injury). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The substabnce is severely irritating and corrosive to the skin, eyes and respiratory tract. Limited conclusions regarding systemic toxicity are possible due to the corrosive effects observed in animals (forestomach corrosion, low urinary pH, clinical indications). Male Rabbit LD50 1120 mg/kg (unabraded skin) Female Rabbit LD50 1171 mg/kg (unabraded skin) Male Rabbit LD50 1400 mg/kg (abraded skin) Female Rabbit LD50 976 mg/kg (abraded skin) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd062f93-f026-4dbf-8ea9-b4a35ac79828/documents/IUC5-b79ca72b-3fa8-4d6e-bc09-4c5749099ae8_72e4bcdc-6707-4dd9-989a-51c9692ab61e.html,,,,,, "N,N-bis[3-(dimethylamino)propyl]-N',N'-dimethylpropane-1,3-diamine",33329-35-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd062f93-f026-4dbf-8ea9-b4a35ac79828/documents/IUC5-b79ca72b-3fa8-4d6e-bc09-4c5749099ae8_72e4bcdc-6707-4dd9-989a-51c9692ab61e.html,,oral,LD50,"2,385 mg/kg bw",adverse effect observed, "N,N-bis[3-(dimethylamino)propyl]-N',N'-dimethylpropane-1,3-diamine",33329-35-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd062f93-f026-4dbf-8ea9-b4a35ac79828/documents/IUC5-b79ca72b-3fa8-4d6e-bc09-4c5749099ae8_72e4bcdc-6707-4dd9-989a-51c9692ab61e.html,,dermal,LD50,976 mg/kg bw,adverse effect observed, "N,N-bis[3-(dimethylamino)propyl]-N',N'-dimethylpropane-1,3-diamine",33329-35-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd062f93-f026-4dbf-8ea9-b4a35ac79828/documents/IUC5-b79ca72b-3fa8-4d6e-bc09-4c5749099ae8_72e4bcdc-6707-4dd9-989a-51c9692ab61e.html,,inhalation,LC50,1.8 mg/m3,adverse effect observed, "N,N-dibutylbutan-1-aminium bis[2-(hydroxy-kO)benzoato(2-)-kO]borate(1-)",22450-96-0,Acute toxicity oral: LD50 > 2000 mg/kg bodyweight (OECD 423) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a592d578-9010-4bdf-bb0e-25b091e5d151/documents/c9d23c6e-ca83-49d3-9310-48486789d9f2_40984c75-6859-4559-be6d-d99813b26285.html,,,,,, "N,N-dibutylbutan-1-aminium bis[2-(hydroxy-kO)benzoato(2-)-kO]borate(1-)",22450-96-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a592d578-9010-4bdf-bb0e-25b091e5d151/documents/c9d23c6e-ca83-49d3-9310-48486789d9f2_40984c75-6859-4559-be6d-d99813b26285.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N-dibutylformamide",761-65-9,oral: LD50 = 1050 mg/kg bw (rat)inhalative: no death observed under saturated atmosphere (rat)dermal: LD50 male animals 790 mg/kg ; female; 730 mg/kg (rat) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b69db2f-1a07-49b3-b625-e8f0a930473b/documents/2c9f37c1-7864-4b63-9827-f8373edeeabb_475377da-1ab7-4d65-8738-54e3636afc32.html,,,,,, "N,N-dibutylformamide",761-65-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b69db2f-1a07-49b3-b625-e8f0a930473b/documents/2c9f37c1-7864-4b63-9827-f8373edeeabb_475377da-1ab7-4d65-8738-54e3636afc32.html,,oral,LD50,"1,050 mg/kg bw",adverse effect observed, "N,N-dibutylformamide",761-65-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b69db2f-1a07-49b3-b625-e8f0a930473b/documents/2c9f37c1-7864-4b63-9827-f8373edeeabb_475377da-1ab7-4d65-8738-54e3636afc32.html,,dermal,LD50,730 mg/kg bw,adverse effect observed, "N2,N4-dibutyl-N2,N4-bis(1,2,2,6,6-pentamethyl-4-piperidyl)-6-pyrrolidin-1-yl-1,3,5-triazine-2,4-diamine",1702355-94-9, A single dose of the test item was administered orally or dermally to Wistar rats at concentrations of 2000 mg/kg bw. No mortality occurred. Clinical examiniation and gross necropsy did not reveal any findings. The LD50 after oral and dermal administration is therefore considered to be > 2000 mg/kg bw. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ca70a95-d5f4-44c5-86f3-09e6f4ce2fae/documents/224a1ea5-42b2-400c-a6d4-41fadb017bc7_1c92cc5f-cbb9-43c9-ba3d-44b4c057e057.html,,,,,, "N2,N4-dibutyl-N2,N4-bis(1,2,2,6,6-pentamethyl-4-piperidyl)-6-pyrrolidin-1-yl-1,3,5-triazine-2,4-diamine",1702355-94-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ca70a95-d5f4-44c5-86f3-09e6f4ce2fae/documents/224a1ea5-42b2-400c-a6d4-41fadb017bc7_1c92cc5f-cbb9-43c9-ba3d-44b4c057e057.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "N2,N4-dibutyl-N2,N4-bis(1,2,2,6,6-pentamethyl-4-piperidyl)-6-pyrrolidin-1-yl-1,3,5-triazine-2,4-diamine",1702355-94-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ca70a95-d5f4-44c5-86f3-09e6f4ce2fae/documents/224a1ea5-42b2-400c-a6d4-41fadb017bc7_1c92cc5f-cbb9-43c9-ba3d-44b4c057e057.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N-dibutyloleamide",5831-80-1,Single oral gavage of the test item to male and female rats did not cause any adveres effects. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a6bd3ba-4e40-4eaa-af5d-002e8e255859/documents/e0efca8a-4fa0-4406-9a08-129706848dbf_7f71f34f-9faa-4427-88ea-c3fa66f38a3a.html,,,,,, "N,N-dibutyloleamide",5831-80-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a6bd3ba-4e40-4eaa-af5d-002e8e255859/documents/e0efca8a-4fa0-4406-9a08-129706848dbf_7f71f34f-9faa-4427-88ea-c3fa66f38a3a.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N,N-dicyclohexylbenzothiazole-2-sulphenamide",4979-32-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The endpoint is concluded based on a key subchronic toxicity study on DCBS conducted according to GLP and with minimal deviations by comparison to the most relevant version of the test guideline (OECD 408). It has been evaluated to be of good quality (Klimisch score = 1). Further supporting evidence is available from Supporting studies of good quality (Klimisch scores 1 & 2) conducted according to test guideline or good scientific principle, and well documented. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fee2b68-ba0f-4da9-8245-9a837f3fa09c/documents/2773e432-4a1b-4ed7-b09e-ffa1e89a8cb6_578dd9a5-4f5e-4954-bc43-dbdd91a63ba7.html,,,,,, "N,N-dicyclohexylbenzothiazole-2-sulphenamide",4979-32-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fee2b68-ba0f-4da9-8245-9a837f3fa09c/documents/2773e432-4a1b-4ed7-b09e-ffa1e89a8cb6_578dd9a5-4f5e-4954-bc43-dbdd91a63ba7.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rabbit "N,N-dicyclohexylbenzothiazole-2-sulphenamide",4979-32-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fee2b68-ba0f-4da9-8245-9a837f3fa09c/documents/2773e432-4a1b-4ed7-b09e-ffa1e89a8cb6_578dd9a5-4f5e-4954-bc43-dbdd91a63ba7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,36.9 mg/kg bw/day,,rat "N,N-dicyclohexylbenzothiazole-2-sulphenamide",4979-32-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fee2b68-ba0f-4da9-8245-9a837f3fa09c/documents/ca5d5f43-daa9-427a-b09d-1c54023e4475_578dd9a5-4f5e-4954-bc43-dbdd91a63ba7.html,,oral,LD50,"5,000 mg/kg bw",, "N,N-dicyclohexylbenzothiazole-2-sulphenamide",4979-32-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fee2b68-ba0f-4da9-8245-9a837f3fa09c/documents/ca5d5f43-daa9-427a-b09d-1c54023e4475_578dd9a5-4f5e-4954-bc43-dbdd91a63ba7.html,,dermal,LD50,"5,000 mg/kg bw",, "N,N-diethyl-2-propynylamine",4079-68-9," Oral: LD50 = ca. 472 mg/kg bw (rat, test similar to OECD 401) Dermal: LD50: 460 mg/kg bw (rabbit) Inhalation: LC50 = 2100 mg / m3 (rat, 4h, test similar to OECD 403) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcd7081e-0a2f-4b39-88f8-b3816400a7e7/documents/5ae81318-60f3-4f8b-8280-d0c58ddcfe61_5c1655b5-cb1d-4f60-99c9-482fb5e6940d.html,,,,,, "N,N-diethyl-2-propynylamine",4079-68-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcd7081e-0a2f-4b39-88f8-b3816400a7e7/documents/5ae81318-60f3-4f8b-8280-d0c58ddcfe61_5c1655b5-cb1d-4f60-99c9-482fb5e6940d.html,,oral,LD50,472 mg/kg bw,adverse effect observed, "N,N-diethyl-2-propynylamine",4079-68-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcd7081e-0a2f-4b39-88f8-b3816400a7e7/documents/5ae81318-60f3-4f8b-8280-d0c58ddcfe61_5c1655b5-cb1d-4f60-99c9-482fb5e6940d.html,,dermal,LD50,460 mg/kg bw,adverse effect observed, "N,N-diethyl-2-propynylamine",4079-68-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcd7081e-0a2f-4b39-88f8-b3816400a7e7/documents/5ae81318-60f3-4f8b-8280-d0c58ddcfe61_5c1655b5-cb1d-4f60-99c9-482fb5e6940d.html,,inhalation,LC50,"2,100 mg/m3",adverse effect observed, "N,N-diethyl-3-oxobutyramide",2235-46-3," Repeated dose toxicity: Oral NOAEL was considered to be in the range of 90 to 1000 mg/kg bw when mice and rat were treated wtih N,N-Diethyl-3-oxobutyramide. Thus, comparing this value with the criteria of CLP regulation N,N-Diethyl-3-oxobutyramide (CAS no 20306-75-6) is not likely to classify as repeated dose toxicant. Repeated dose inhalation toxicity: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance N,N-Diethyl-3-oxobutyramide (CAS no 20306-75-6),which is reported as 0.01 mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical 2-Undecanone is highly unlikely. Therefore this study is considered for waiver. Repeated dose dermal toxicity: In accordance with coloumn 2 of Annex IX, this end point was considered for waiver since the acute toxicity by the dermal route has already been provided in section 7.2.3 (as part of the Annex VIII information requirements) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2149fc08-4718-4ab6-9885-d86fe53da6ff/documents/912b1015-1854-4290-8e30-2d1537ebd793_ae40f9a1-604d-45b0-b093-debbab785a8e.html,,,,,, "N,N-diethyl-3-oxobutyramide",2235-46-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2149fc08-4718-4ab6-9885-d86fe53da6ff/documents/912b1015-1854-4290-8e30-2d1537ebd793_ae40f9a1-604d-45b0-b093-debbab785a8e.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,mouse "N,N-diethyl-3-oxobutyramide",2235-46-3," Acute oral toxicity:  Acute oral toxicity dose (LD50) of target chemical N,N-diethyl-3-oxobutyramide (CAS no: 2235-46-3) was considered based on experimental study, the LD50 cut-off value was considered to be 5000 mg/kg in rats. The study concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, N,N-diethyl-3-oxobutyramide cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  Acute Inhalation toxicity dose (LC50) for N,N-diethyl-3-oxobutyramide (CAS no: 2235-46-3) was considered based on data available for the structurally and functionally similar read across chemicals. The LC50 value is >5 mg/L. Thus, comparing this value with the criteria of CLP regulation, N,N-diethyl-3-oxobutyramide cannot be classified for acute inhalation toxicity. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for N,N-diethyl-3-oxobutyramide (CAS no: 2235-46-3) was considered based on experimental study conducted on rats, the LD50 value considered to be >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, N,N-diethyl-3-oxobutyramide cannot be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2149fc08-4718-4ab6-9885-d86fe53da6ff/documents/a8749fe0-78d6-4802-ab1d-a40073767d0f_ae40f9a1-604d-45b0-b093-debbab785a8e.html,,,,,, "N,N-diethyl-3-oxobutyramide",2235-46-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2149fc08-4718-4ab6-9885-d86fe53da6ff/documents/a8749fe0-78d6-4802-ab1d-a40073767d0f_ae40f9a1-604d-45b0-b093-debbab785a8e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "N,N-diethyl-3-oxobutyramide",2235-46-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2149fc08-4718-4ab6-9885-d86fe53da6ff/documents/a8749fe0-78d6-4802-ab1d-a40073767d0f_ae40f9a1-604d-45b0-b093-debbab785a8e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N-diethyl-3-oxobutyramide",2235-46-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2149fc08-4718-4ab6-9885-d86fe53da6ff/documents/a8749fe0-78d6-4802-ab1d-a40073767d0f_ae40f9a1-604d-45b0-b093-debbab785a8e.html,,inhalation,LC50,"142,000 mg/m3",no adverse effect observed, "N,N-Diethylacrylamide",2675-94-7, Acute oral: The LD50 to rats of test item was estimated to be 739 mg/kg bodyweight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e88b1ed-2e59-4873-905f-8be78429f4a6/documents/0681608f-b75b-482b-92bb-4979d6e832f5_86662a15-3260-47a8-a45a-e72b33919324.html,,,,,, "N,N-Diethylacrylamide",2675-94-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e88b1ed-2e59-4873-905f-8be78429f4a6/documents/0681608f-b75b-482b-92bb-4979d6e832f5_86662a15-3260-47a8-a45a-e72b33919324.html,,oral,LD50,739 mg/kg bw,adverse effect observed, "N,N-diethylaniline",91-66-7," Repeated dose toxicity: Oral In a subacute repeated-dose toxicity study, Wistar rats (male and female; number unspecified) were administered the test chemical via gavage at 0, 10, 50 or 250 mg/kg-bw/day, 7 days/week for 28 days. No mortalities were observed. No changes in body weight, food, and water consumption were reported. Clinical signs of toxicity consisted of increased frequency of respiratory sounds in males at 50 mg/kg-bw/day, and increased frequency of respiratory sounds and salivation in females at 250 mg/kg-bw/day. Hematological effects (decreased red cell counts, decreased hemoglobin concentrations, decreased packed cell volume (PCV) in both sexes and increased mean corpuscular volume (MCV) and mean corpuscular hemoglobin (MCH) in females) were reported at all doses (dose-response not specified). Histological effects were reported for the liver and spleen. In the liver, hemosiderosis of the Kupffer cells at 10 mg/kg-bw/day and extra medullary hematopoeisis at 50 and 250 mg/kg-bw/day were observed. In the spleen, hemosiderosis, extramedullary hematopoiesis and splenic hyperemia were reported at 10 mg/kg-bw/day. Swollen spleens were observed at 50 and 250 mg/kg-bw/day. Increased absolute and relative weights and black pigmentation of the spleen were also reported at 10mg/kg-bw/day. At 50 and 250 mg/kg-bw/day, hyperbilirubinemia, polychromasia were reported, and at 250 mg/kg-bw/day, decreased potassium levels, histopathological findings in the kidneys of both sexes, black pigmentation in the kidneys of females, and increased albumin levels in males were reported. Dose-response and statistical significance were not indicated for any of these observed effects. Based on hematological and histopathological changes in the spleen and liver consistent with hemolytic anemia observed the Low observed adverse effect level (LOAEL) for the test chemical using Wistar rats was considered to be 10 mg/kg-bw/day. Repeated dose toxicity: Inhalation The test chemical is likely to have a no observed adverse effect concenration (NOAEC) of 9.2 mg/m3 air upon repeated exposure by inhalation route to rats. Repeated dose toxicity: Dermal The acute dermal toxicity value for N,N-diethylaniline (CAS no 91-66-7)  (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c073c332-2394-4dd2-bc4b-023ec479df45/documents/ce1f8576-fd5c-4e72-8785-15899e6e1ea4_ac0de471-8ae9-4c7e-82cf-d42cbbb61b5a.html,,,,,, "N,N-diethylaniline",91-66-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c073c332-2394-4dd2-bc4b-023ec479df45/documents/ce1f8576-fd5c-4e72-8785-15899e6e1ea4_ac0de471-8ae9-4c7e-82cf-d42cbbb61b5a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "N,N-diethylaniline",91-66-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c073c332-2394-4dd2-bc4b-023ec479df45/documents/ce1f8576-fd5c-4e72-8785-15899e6e1ea4_ac0de471-8ae9-4c7e-82cf-d42cbbb61b5a.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,9.2 mg/m3,,rat "N,N-diethylaniline",91-66-7," Acute oral toxicity:    The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute oral toxicity class IV.   Acute Inhalation Toxicity:   The acute inhalation toxicity dose (LC50) was considered based on different studies conducted on rats and mice for the test chemical. The LC50 value is between 500-2500 ppm, for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute inhalation toxicity class III.   Acute Dermal toxicity:   The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is between 200-1000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute dermal toxicity class III. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c073c332-2394-4dd2-bc4b-023ec479df45/documents/73afa715-3f41-45cf-bad2-66d63b20ac81_ac0de471-8ae9-4c7e-82cf-d42cbbb61b5a.html,,,,,, "N,N-diethylaniline",91-66-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c073c332-2394-4dd2-bc4b-023ec479df45/documents/73afa715-3f41-45cf-bad2-66d63b20ac81_ac0de471-8ae9-4c7e-82cf-d42cbbb61b5a.html,,oral,LD50,782 mg/kg bw,no adverse effect observed, "N,N-diethylaniline",91-66-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c073c332-2394-4dd2-bc4b-023ec479df45/documents/73afa715-3f41-45cf-bad2-66d63b20ac81_ac0de471-8ae9-4c7e-82cf-d42cbbb61b5a.html,,dermal,LD50,935 mg/kg bw,no adverse effect observed, "N,N-diethylaniline",91-66-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c073c332-2394-4dd2-bc4b-023ec479df45/documents/73afa715-3f41-45cf-bad2-66d63b20ac81_ac0de471-8ae9-4c7e-82cf-d42cbbb61b5a.html,,inhalation,LC50,"4,144.43 mg/m3",no adverse effect observed, "N,N-diethylhydroxylamine",3710-84-7," 1 -Diethylhydroxylamine toxicity was evaluated in a 28-day study in rats performed according to the OECD TG # 412 (Naas, 1996a). The test article was administered via nose-only inhalation to three groups, each comprised of 15 male and 15 female Crl: CDBR rats, for a period of six hours per day, five days per week, for four consecutive weeks (minimum of 20 total exposures). The targeted exposure concentrations were 15, 150 and 1500 ppm. The test atmosphere concentrations were monitored by infrared absorbance and were found to be 15, 150 and 1500 ppm (54.6, 546.0 and 5481.8 mg/m3). A concurrent control group of identical design received only filtered air, on a comparable regimen. The animals were observed for clinical signs and effects on body weight, food consumption and clinical pathology parameters. Data from detailed physical examinations, including Functional Observational Battery data (handling and open field observations), were recorded during the pretest period and during weeks 0 through 5. After completion of exposure, 5 rats/sex/group entered an approximate two-week (non exposure) recovery period, after which they were euthanized; necropsies were performed, and selected organs were weighed. The remaining rats in each group were euthanized immediately following the exposure period and necropsied as described above. A microscopic examination was conducted on selected tissues from all groups.In the control, 15, 150 and 1500 ppm groups, 2, 1, 2 and 2 animals, respectively, were found dead during the study. These deaths were noted while the animals were in the exposure tube either prior to exposure, during exposure or at the time of unloading from the exposure tubes. The deaths did not occur in an exposure-related manner and were not related to exposure to the test article. All other animals survived to the scheduled necropsies. The predominant treatment-related clinical signs were dried yellow dorsal posterior and urogenital matting, lack of grooming, eye closure and hypoactivity in males and females in the 1500 ppm group, and ataxia, paleness in color, walking on tiptoes and hunched posture in the females in this group. The findings of ataxia, paleness in color, walking on tiptoes, hunched posture, eye closure and hypoactivity were transient in that they occurred only at the post-exposure observation and not prior to exposure or during the Functional Observational Battery. During the recovery period, no significant findings were noted at any exposure level. The only potential test article-related finding noted during the Functional Observational Battery evaluations (handling and open field observations) was an increase in slightly soiled or very soiled fur in the 1500 ppm group males and females during weeks 0 to 2. During the recovery period, no test article-related findings were noted during the Functional Observational Battery evaluations. Reductions in mean body weight gain were noted in males and females in the 1500 ppm group during week 0-1 and in males in this group throughout the remainder of the exposure period. Food consumption was reduced in the 1500 ppm group males and females during week 0-1. During the recovery period, body weights and food consumption in these animals were similar to the control group values. At the week 4 evaluation, the segmented neutrophil count was increased in the 1500 ppm group mates and females, and the lymphocyte count was reduced in the females in this group. Alkaline phosphatase and phosphorous values were increased in the 1500 ppm group males and females at the week 4 evaluation. At the week 4 evaluation, albumin levels were decreased in the 1500 ppm group (both sexes) and the 150 ppm group (females only), and globulin was increased in the 1500 ppm females. These changes corresponded with decreased A/G ratios in the 1500 ppm group (both sexes) and the 150 ppm group females. A slight but statistically significant increase in alanine aminotransferase in the 1500 ppm group females (week 4) may also have been treatment-related. Bile acids were increased in the mates in the 1500 ppm group at the week 4 evaluation. At the week 6 evaluation, the values for all of these parameters were similar to the control group values. (Although bile acids appeared elevated at the week 6 evaluation for 1500 ppm mates, this was due to a low control value and unrelated to the test article.) Other hematology and serum chemistry values and urinalysis parameters were unaffected by exposure to the test article at any exposure level. No test article-related internal fmdings were noted at the necropsies of animals that died during the study or at the scheduled necropsies. At the week 4 necropsy, thymus gland weights (relative and absolute) were reduced in males and females in the 1500 ppm group. Mean liver weights (absolute and relative) were increased in the 1500 ppm group females at the week 4 necropsy. Organ weights were comparable to the control group values at the week 6 (recovery) necropsy. test article-related microscopic observations were noted. At the week 4 necropsy, reversible test article-related microscopic changes consisting primarily of non suppurative mucosal inflammation, but also including squamous hyperplasia and necrosis in a limited number of animals, were noted in the nasal passages of male and female rats in the 150 and 1500 ppm groups; these effects were considered to be local, not systemic. At the recovery necropsy, only one rat of each sex in the 1500 ppm group had minimal non suppurative mucosal inflammation in the nasal cavity. Medullary plasmacytosis was noted at an increased incidence in the iliac and popliteal lymph nodes in males in the 1500 ppm group. At the recovery necropsy, no exposure-related microscopic effects were noted in males or females at any dose level.In conclusion, toxicity was exhibited in the 1500 ppm group by clinical signs, inhibition of body weight gain and food consumption, changes in white blood cell differential counts, various serum chemistry changes, reduced thymus gland weights-and increased liver weights. Medullary plasmacytosis was noted in the iliac and popliteal lymph nodes in males in the 1500 ppm group. Systemic effects in the 150 ppm group were limited to slight decreases in albumin and A/G ratio (females only). Based on data collected following a two-week non exposure (recovery) period, all of these effects were considered to be reversible. Microscopic changes were noted in the nasal passages of male and female rats in the 150 and 1500 ppm groups; these effects were considered to be due to local irritation, not systemic toxicity, and reversible. The hematological, serum chemistry and organ weight (thymus and liver) effects in the 1500 ppm group indicate that the liver and thymus were the target organs, however, no test article related histomorphological changes were seen in these tissues. Based on these results, exposure levels of 150 ppm (546.0 mg/m3) and 15 ppm (54.6 mg/m3) were considered to be the NOAEC (no observed adverse effect concentration) and NOEC (no observed effect concentration), respectively, for systemic toxicity and the exposure level of 15 ppm (54.6 mg/m3) was considered to be the NOEC for nasal irritation.In a range-finding study, diethylhydroxylamine was administered to three groups of 5 male and5 female CD rats by nose-only inhalation for a period of six hours per day, for five days (Naas, 1996b). Test atmosphere concentrations were monitored by infrared absorbance and were found to be 15, 149, 450 and 1541 ppm (target concentrations were 15, 150, 450 and 1500 ppm). A control group received filtered air. Urogenital matting was noted on the first day of exposure, only. Body weight gain and food consumption were slightly reduced at 1500 ppm throughout the week. Liver weights (absolute) were increased at 450 ppm and 1500 ppm in females (statistically significant at 1500 ppm), and mean weights were significantly increased at 450 ppm and 1500 ppm in females.Long-Evans hooded rats were exposed for at least 2 years by inhalationto9-27 ppm diethylhydroxylamine and the vapor of diethylamine hydrogen sulfite (Heicklen et al., 1981). In one of three test chambers each containing 45-49 rats, the rats were also exposed to 9 ± 2 ppm of nitroethane. In thefirst12 months of the experiment two males and two females from both the control chamber and the chamber containing all three gases were sacrificed at 3-month intervals. After the first year only moribund animals were sacrificed except at the very end of the study when all remaining animals were sacrificed. Although haematological and blood chemistry evaluations indicated no significant differences between the control and exposed animals, gross and microscopic pathology findings showed some variations, especially in the first year. Very early one test animal developed a hemangioendothelioma, but no additional ones developed later. Also hydrometra of the uterus, a condition common in old virgin female rats, was found in four exposed and one control female. Chronic tracheitis was found in five exposed and two control animals. Thyroid lesions were seen in the exposed animals after 6 months exposure, but not in animals exposed 9 months or longer. Examinations for animals exposed more than1 year indicated no significant differences between the control and test groups, except for interstitial cell tumors of the testes which showed up in 4 of the 47 exposed males that were examined comparedto0in the 25 control males. However, this incidence (8.5%) is too small to establish any definite conclusion. 2-Diethylhydroxylamine was evaluated in a 28-day repeated dose study on rats according to OECD 407 guideline (Shin Nippon, 2000). 5 males and 5 females were given the dose-levels at 20, 100 and 500 mg/kg/day . The control group was given purified water as a vehicle. A recovery group was was added for the high dose-level and the control. During the dosing and recovery periods , no animals died in any group. In clinical signs, salivation and reddih eye gum in males and females, reddih rhinorrhea in males and reddish urine in females werer observed transiently after dosing in the 500 mg/kg/day group. No abnormalities were observed in clinical signs in any animal during the recovery period. In general behaviour, salivation was observed in males in the 500 mg/kg/day group on day 27 of the dosing period. No abnormalities were observed during the recovery period. No test article related changes were noted in food consmuption, body weight, ophthalmology, urinalysis, hematology blood biochemistry, gross pathology, organ weight or histopathology. It was concluded from these results that under the conditions of this study, the NOEL was 100 mg/kg/day and the NOAEL was 500 mg/kg/d in both males and females. Additionally, the changes that were noted during the dosing period were judged to be reversible. 3-The potential toxicity of the test item,N, N-DIETHYLHYDROXYLAMINE, was evaluated after daily oral administration (gavage) to rats at 50, 150 and 500 mg/kg/day for 13 weeks, followed by a 6-week treatment-free period according to OECD 408 guideline (Modeste, 2018).  Treatment-related clinical signs were limited to ptyalism at the high-dose only. Non-adverse treatment-related changes were seen at blood biochemistry and sperm analysis. There were no effects on body weight, food consumption, estrous cycles, hematology parameters, thyroid hormones and there were no test item-related ophthalmological findings.  Non-adverse changes were observed at pathology in the kidneys, liver, adrenals, forestomach and stomach at 500 mg/kg/day, and in the kidneys and adrenals at 150 and 50 mg/kg/day.  Under the experimental conditions of the study and based on the absence of adverse effects up to the high-dose, the No Observed Adverse Effect Level (NOAEL) in rats administered N, N-DIETHYLHYDROXYLAMINEfor 13 weeks was set at 500 mg/kg/day. 4 -Low level (9-27 ppm diethylhydroxylamine) inhalation exposure of rats for 2 years did not indicate any evidence of systemic toxicity and nasal irritation, however this study was complicated by the co-administration of nitroethane and/or diethylamine hydrogen sulfite ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfcc2451-ba0c-4595-a41c-cf86c90f9991/documents/6171bff6-4c99-474c-9d9d-40f5695c95c9_140846f3-515f-4849-9f59-5642f456c2f0.html,,,,,, "N,N-diethylhydroxylamine",3710-84-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfcc2451-ba0c-4595-a41c-cf86c90f9991/documents/6171bff6-4c99-474c-9d9d-40f5695c95c9_140846f3-515f-4849-9f59-5642f456c2f0.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,546 mg/m3,,rat "N,N-diethylhydroxylamine",3710-84-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfcc2451-ba0c-4595-a41c-cf86c90f9991/documents/6171bff6-4c99-474c-9d9d-40f5695c95c9_140846f3-515f-4849-9f59-5642f456c2f0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "N,N-diethylhydroxylamine",3710-84-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfcc2451-ba0c-4595-a41c-cf86c90f9991/documents/6171bff6-4c99-474c-9d9d-40f5695c95c9_140846f3-515f-4849-9f59-5642f456c2f0.html,Repeated dose toxicity – local effects,inhalation,NOAEC,54.6 mg/m3,adverse effect observed,rat "N,N-diethylhydroxylamine",3710-84-7," Oral route In a pre-guideline study, groups of 5 WBS/W rats were administered dose levels of 1400, 2000, 2800, 4000 mg/kg bw of diethylhydroxylamine (undiluted) by stomach tube (Latven, 1977a). The animals were then observed for 7 days following exposure. At 4000 mg/kg, 5/5 rats died, at 2800 mg/kg bw 4/5 rats died, at 2000 mg/kg bw, 2/5 rats died and at 1400 mg/kg bw none died. Clinical observations revealed muscular incoordination and general depression. Autopsy findings were negative. The LD50 was 2190 mg/kg bw. In a pre-guideline study, groups of 2, 5 or 10 male OF1 mice were administered dose levels of 875, 1000, 1300, 1800, 2400, 3200, 4300, 8750 mg/kg bw of diethylhydroxylamine by stomach tube (Latven, 1957). The animals were then observed for 7 days following exposure. No mortality was observed at 875, 1000 and 1300 mg/kg bw, at 1800 mg/kg, 2/10 mice died, at 2400 mg/kg bw 7/10 mice died, at 3200 mg/kg bw, 10/10 mice died and at 4300 and 8750 mg/kg bw 2/2 mice died. Clinical observations revealed decrease motor activity, ataxia, complete inactivity, muscular hypotonicity, loss of righting reflex, muscular spasms, mild clonic convulsions, respiratory depression, cyanosis and death. The LD50 was 2150 mg/kg bw. Inhalation route In an acute inhalation toxicity study performed according to the US EPA guideline (Terrill, 1986), series of groups consisting of five male and five female Sprague-Dawley derived rats was exposed to diethylhydroxylamine vapor for four hours mean analytical levels in the range of 1410 to 4720 parts per million (ppm). At 1410 and 2650 ppm, no rat died, 3240 and 3560 ppm, 1/5 male and 5/5 female rats died, and at 4720 ppm, all rats died. The mortality results indicated the test material was more lethal to female rats than to male rats. Signs attributable to treatment included death, increased incidences of secretory responses, respiratory distress, general signs of poor condition, corneal opacity and loss of body weight. Overall, the time-to-onset and time-to-recovery of these signs were related to exposure concentration. The lungs of numerous animals, both treated and control, were discoloured primarily scattered red-grey foci were observed in the animals which were killed at the end of the study, whereas in the animals which died, the lungs were bright to dark red. The toxicologic significance of these findings, if any, cannot be determined on the basis of a gross examination only. The LC50 was determined 4400 ppm for the males, 2620 ppm for the females and 3140 ppm for both sexes combined. Dermal route In a pre-guideline study, groups of 4 albino rabbits were treated dermally under a pre-fitted occluding sleeve with 707, 1000, 1414 and 2000 mg/kg body weight of diethylhydroxylamine (Latven, 1980a). The occluding sleeve was removed 24 hours following exposure and the animals were observed for 7 days. No rabbit died at 707 mg/kg/bw, at 1000 mg/kg bw, 1/4 rabbit died, at 1414 mg/kg bw, 2/4 rabbits died and at 2000 mg/kg bw, all rabbits died. The clinical signs observed were hypersensitivity, mydriasis, and incoordination prior to toxic incapacitation. The acute dermal LD50was 1300 mg/kg bw. In two other pre-guideline studies (Latven, 1977 and 1979), groups of three albino rabbits were treated dermally with a single dose of 2000 mg/kg (2.24 ml/kg) diethylhydroxylamine and three additional rabbits were treated with a single dose of 200 mg/kg (2.0 ml/kg of a 10% W/V aqueous dilution). Individual doses were applied to the fur-clipped skin of the trunk under a pre-fitted impervious sleeve on each of the animals. After a skin-contact period of 24 hours, the sleeves were removed and in one study (Latven, 1979) the treated sites were gently cleansed with a 2% solution of acetic acid. Surviving animals were then observed for seven days. All animals died at 2000 mg/kg bw and none at 200 mg/kg bw.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfcc2451-ba0c-4595-a41c-cf86c90f9991/documents/77e2c71f-2019-450f-890a-be38f67d4228_140846f3-515f-4849-9f59-5642f456c2f0.html,,,,,, "N,N-diethylhydroxylamine",3710-84-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfcc2451-ba0c-4595-a41c-cf86c90f9991/documents/77e2c71f-2019-450f-890a-be38f67d4228_140846f3-515f-4849-9f59-5642f456c2f0.html,,oral,LD50,"2,190 mg/kg bw",adverse effect observed, "N,N-diethylhydroxylamine",3710-84-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfcc2451-ba0c-4595-a41c-cf86c90f9991/documents/77e2c71f-2019-450f-890a-be38f67d4228_140846f3-515f-4849-9f59-5642f456c2f0.html,,dermal,LD50,"1,300 mg/kg bw",adverse effect observed, "N,N-diethylhydroxylamine",3710-84-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfcc2451-ba0c-4595-a41c-cf86c90f9991/documents/77e2c71f-2019-450f-890a-be38f67d4228_140846f3-515f-4849-9f59-5642f456c2f0.html,,inhalation,LC50,"11,400 mg/m3",adverse effect observed, "N,N-diethyl-p-(phenylazo)aniline",2481-94-9, Acute oral toxicity: LD50 was estimated to be 1509 mg/kg bw when Wistar female rats were orally exposed with 4-(Diethylamino)azobenzene. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c010e96-b2e6-4446-b1e6-2f729cd1ef88/documents/d55a1dc7-d5f7-4257-b68e-b5579bcd207c_85f3c23b-6fc4-47bb-ba63-e2b47ddad07b.html,,,,,, "N,N-diethyl-p-(phenylazo)aniline",2481-94-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c010e96-b2e6-4446-b1e6-2f729cd1ef88/documents/d55a1dc7-d5f7-4257-b68e-b5579bcd207c_85f3c23b-6fc4-47bb-ba63-e2b47ddad07b.html,,oral,LD50,"1,509 mg/kg bw",adverse effect observed, "N,N-dimethyl-3-oxobutyramide",2044-64-6,"A combined repeated dose toxicity study with reproduction/developmental toxicity screening test was conducted according to OECD 422 and EPA OPPTS 870.365. The test material was determined in a 28 day oral study performed in line with GLP. Rats (10/sex/dose level) were dosed once daily by gavage at dose levels of 0, 100, 300, or 1000 mg/kg bw/day. Under the conditions of this study, the no-observed-effect level (NOEL) for systemic toxicity was 100 mg/kg bw/day due to decreased body weights and body weight gains and increased hyaline droplets in males at >= 300 mg/kg bw/day. Hyaline droplets are, however, species/sex-specific, occurring only in male rats. Female rats were not affected up to the highest dose tested (1000 mg/kg bw/day). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5f626d92-ad2e-4e8e-b9df-3fb9b6d23bec/documents/IUC5-29d15b27-f23e-4e08-9e89-550d1b5eb8df_933b95e7-b57e-4d39-ab83-2b3951abc09d.html,,,,,, "N,N-dimethyl-3-oxobutyramide",2044-64-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5f626d92-ad2e-4e8e-b9df-3fb9b6d23bec/documents/IUC5-29d15b27-f23e-4e08-9e89-550d1b5eb8df_933b95e7-b57e-4d39-ab83-2b3951abc09d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "N,N-dimethyl-3-oxobutyramide",2044-64-6,"Oral toxicity:------------In the oral toxicity study no animals died during the observation period. No clinical signs were observed during the fourteen days. Therefore, the LD50 of the test item is > 5000 mg/kg bw.Inhalation toxicity:-----------------The acute inhalation study was waived taking in to account the vapour pressure and the aggregate state of the substance (liquid). The second likely route of human exposure is by dermal route. Therefore a dermal study was performed. Dermal toxicity:-------------- No death occurred in a dermal toxicity study after the single 2000 mg/kg bw dermal dose of LZ705. There were no systemic toxic clinical signs in both sexes and no any related effect of the test item found in body weights and body weight gains of animals during the study. Autopsy revealed no treatment related pathological changes. Under the experimental conditions, the acute dermal LD50 value of the test item LZ705 was determined to be greater than 2000 mg/kg bw in male and female Crl:(WI)BR rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f626d92-ad2e-4e8e-b9df-3fb9b6d23bec/documents/IUC5-5ca60f76-c8a6-414d-8152-93f5fbda1817_933b95e7-b57e-4d39-ab83-2b3951abc09d.html,,,,,, "N,N-dimethyl-3-oxobutyramide",2044-64-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f626d92-ad2e-4e8e-b9df-3fb9b6d23bec/documents/IUC5-5ca60f76-c8a6-414d-8152-93f5fbda1817_933b95e7-b57e-4d39-ab83-2b3951abc09d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "N,N-dimethyl-3-oxobutyramide",2044-64-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f626d92-ad2e-4e8e-b9df-3fb9b6d23bec/documents/IUC5-5ca60f76-c8a6-414d-8152-93f5fbda1817_933b95e7-b57e-4d39-ab83-2b3951abc09d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N-dimethyldodec-9-enamide",1374570-57-6,Short term repeated dose toxicity: oral - NOAEL (rat) = 300 mg/kg bw/day (OECD TG 422) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f158e011-6011-4880-b677-fcf5e81ade55/documents/6a6e9ab5-26bf-4ed2-b296-801375c15b6d_475110db-3484-4cd0-a683-031bf85e0a60.html,,,,,, "N,N-dimethyldodec-9-enamide",1374570-57-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f158e011-6011-4880-b677-fcf5e81ade55/documents/6a6e9ab5-26bf-4ed2-b296-801375c15b6d_475110db-3484-4cd0-a683-031bf85e0a60.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "N,N-dimethyldodec-9-enamide",1374570-57-6,Acute oral toxicity: LD50 (rat) > 2000 mg/kg bw (OECD TG 420) Acute inhalation toxicity: 4-h LC50 (rat) between 1.01 and 4.89 mg/L (mean achieved aerosol concentrations) (OECD TG 433) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f158e011-6011-4880-b677-fcf5e81ade55/documents/ba29fca3-685e-469a-a48b-205ebf830ed5_475110db-3484-4cd0-a683-031bf85e0a60.html,,,,,, "N,N-dimethyldodec-9-enamide",1374570-57-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f158e011-6011-4880-b677-fcf5e81ade55/documents/ba29fca3-685e-469a-a48b-205ebf830ed5_475110db-3484-4cd0-a683-031bf85e0a60.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "N,N-dimethyldodec-9-enamide",1374570-57-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f158e011-6011-4880-b677-fcf5e81ade55/documents/ba29fca3-685e-469a-a48b-205ebf830ed5_475110db-3484-4cd0-a683-031bf85e0a60.html,,inhalation,LC50,>=1.01 mg/L,adverse effect observed, "N,N-dimethylbutylamine",927-62-8," No data were located for N,N-dimethylbutylamine (DMBA). Therefore, a read across approach from data on n-butanol, n-butylacetate and dimethylamine was undertaken. It is considered justified to utilise information on dimethylamine in a read across approach since, like the registered substance, it is an aliphatic amine with saturated alkyl groups. Furthermore, dimethylamine is considered to be a potential metabolite of the registered substance. It is considered justified to utilise information on n-butanol in a read across approach since it is a potential metabolite of the registered substance. It is considered justified to utilise information on n-butylacetate in a read across approach since its metabolite (n-butanol) is also a potential metabolite of the registered substance. ORAL - Sub-Chronic, n-butanol (K1) The No Observed Adverse Effect Level was determined to be 125 mg/kg bw/day (US EPA, 1986). This value is taken forward for risk assessment. INHALATION - Chronic, dimethylamine (K2) In this study (Buckley et al., 1985) the LOAEC for local effects was 10 ppm dimethylamine (18.7 mg/m³), as evidenced by lesions of the respiratory and olfactory epithelium of rats and mice. The NOAEC for systemic toxicity was 50 ppm DMA (93.5 mg/m³) in both species. Local irritation is the primary mode of action of all free aliphatic amines, and this finding can be transferred to N,N-dimethylbutylamine for assessment. A follow up study (Gross, 1987) confirmed the previously reported respiratory metaplasia seen in the olfactory region of the nose following chronic exposure of rats to DMA (Buckley et al., 1985). - Sub-Chronic, n-butyl acetate (K1) Under the conditions of the study investigating neurotoxicity (David, 1998) the No Observed Adverse Effect Concentration was determined to be 500 ppm (ca. 2350 mg/m³). In a repeated dose toxicity test (David, 2001), the No Observed Adverse Effect Concentration was determined to be 500 ppm (ca. 2350 mg/m³) based on reduced body weight and feed consumption noted for the 1500 and 3000 ppm groups. However, there was no systemic or organ-specific toxicity. Degeneration of the olfactory epithelium at concentrations of 1500 and 3000 ppm was observed in areas of the nasal cavity that have demonstrated carboxylesterase activity (Bogdanffy, 1990: Biotransformation enzymes in the rodent nasal mucosa: the value of a histochemical approach. Environmental Health Perspectives 85, 177–186), but there was no evidence of pulmonary toxicity. The Buckley data are taken forward for risk assessment, as these studies provide a more conservative effect level. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09425021-da33-466c-b6d6-07025629e522/documents/c0d82836-30c5-4e74-9cfd-0e16e5f387e5_747e10f3-1573-4a2a-a17d-b0e0a5e136f5.html,,,,,, "N,N-dimethylbutylamine",927-62-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09425021-da33-466c-b6d6-07025629e522/documents/c0d82836-30c5-4e74-9cfd-0e16e5f387e5_747e10f3-1573-4a2a-a17d-b0e0a5e136f5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "N,N-dimethylbutylamine",927-62-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09425021-da33-466c-b6d6-07025629e522/documents/c0d82836-30c5-4e74-9cfd-0e16e5f387e5_747e10f3-1573-4a2a-a17d-b0e0a5e136f5.html,Chronic toxicity – systemic effects,inhalation,NOAEC,93.5 mg/m3,,rat "N,N-dimethylbutylamine",927-62-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09425021-da33-466c-b6d6-07025629e522/documents/c0d82836-30c5-4e74-9cfd-0e16e5f387e5_747e10f3-1573-4a2a-a17d-b0e0a5e136f5.html,Repeated dose toxicity – local effects,inhalation,LOAEC,18.7 mg/m3,adverse effect observed,rat "N,N-dimethylbutylamine",927-62-8,The substance is highly corrosive to the skin. Deaths occurred following oral and inhalation exposure. Local effects but no systemic effects or deaths were seen following dermal exposure up to 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09425021-da33-466c-b6d6-07025629e522/documents/7224f740-28bc-4d5e-944c-1c76c035f75f_747e10f3-1573-4a2a-a17d-b0e0a5e136f5.html,,,,,, "N,N-dimethylbutylamine",927-62-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09425021-da33-466c-b6d6-07025629e522/documents/7224f740-28bc-4d5e-944c-1c76c035f75f_747e10f3-1573-4a2a-a17d-b0e0a5e136f5.html,,oral,LD50,184 mg/kg bw,adverse effect observed, "N,N-dimethylbutylamine",927-62-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09425021-da33-466c-b6d6-07025629e522/documents/7224f740-28bc-4d5e-944c-1c76c035f75f_747e10f3-1573-4a2a-a17d-b0e0a5e136f5.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "N,N'-dimethyldiphenylthiuram disulphide",10591-84-1,"Repeated dose toxicity: via oral route - Short-term LOAEL (rats, combined) = 100 mg/kg bw/day (OECD 407 / GLP / Rel.1) - Sub-chronic (rats, combined) (OECD 408 / GLP / K / Rel.1): NOAEL = 7 mg/k bw g/day (females)  NOAEL = <7 mg/kg bw/day (males)  LOAEL = 7 mg/kg bw/day (males) - haematotoxicity LOAEL = 20 mg/kg bw/day (females)  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6a7c0ff-7f9e-4d21-8488-023a6c01d58d/documents/IUC5-0a52a294-7130-4462-aab6-0c2404bd5a86_81a97012-3186-4485-9442-3381fcf31055.html,,,,,, "N,N'-dimethyldiphenylthiuram disulphide",10591-84-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6a7c0ff-7f9e-4d21-8488-023a6c01d58d/documents/IUC5-0a52a294-7130-4462-aab6-0c2404bd5a86_81a97012-3186-4485-9442-3381fcf31055.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat "N,N'-dimethyldiphenylthiuram disulphide",10591-84-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6a7c0ff-7f9e-4d21-8488-023a6c01d58d/documents/IUC5-0a52a294-7130-4462-aab6-0c2404bd5a86_81a97012-3186-4485-9442-3381fcf31055.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,7 mg/kg bw/day,,rat "N,N'-dimethyldiphenylthiuram disulphide",10591-84-1,Single oral application of the test item to rats yielded LD50 > 5000 mg/kg bw.   Single inhalation exposure against the test item for 4 hours yielded LC50 > 5000 mg/m.   ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6a7c0ff-7f9e-4d21-8488-023a6c01d58d/documents/IUC5-29002ec8-0b3d-4111-85ad-20cc972a45fa_81a97012-3186-4485-9442-3381fcf31055.html,,,,,, "N,N'-dimethyldiphenylthiuram disulphide",10591-84-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6a7c0ff-7f9e-4d21-8488-023a6c01d58d/documents/IUC5-29002ec8-0b3d-4111-85ad-20cc972a45fa_81a97012-3186-4485-9442-3381fcf31055.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "N,N'-dimethyldiphenylthiuram disulphide",10591-84-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6a7c0ff-7f9e-4d21-8488-023a6c01d58d/documents/IUC5-29002ec8-0b3d-4111-85ad-20cc972a45fa_81a97012-3186-4485-9442-3381fcf31055.html,,inhalation,discriminating conc.,"5,064 mg/m3",no adverse effect observed, "N,N-dimethyldodecanamide",3007-53-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8b52a90-d7cd-4fba-9d85-e15553674980/documents/4962fda6-1dc9-493b-b0d6-cba8d0a43ca6_c0e9c3cf-1656-4da6-8c57-f88b716d5564.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,dog "N,N-dimethyldodecanamide",3007-53-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): highest technical attainable concentration tested ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8b52a90-d7cd-4fba-9d85-e15553674980/documents/a05ab0be-e7a0-416b-9c7a-b7c0b07a7b96_c0e9c3cf-1656-4da6-8c57-f88b716d5564.html,,,,,, "N,N-dimethyldodecanamide",3007-53-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8b52a90-d7cd-4fba-9d85-e15553674980/documents/a05ab0be-e7a0-416b-9c7a-b7c0b07a7b96_c0e9c3cf-1656-4da6-8c57-f88b716d5564.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N,N-dimethyldodecanamide",3007-53-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8b52a90-d7cd-4fba-9d85-e15553674980/documents/a05ab0be-e7a0-416b-9c7a-b7c0b07a7b96_c0e9c3cf-1656-4da6-8c57-f88b716d5564.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "N,N-dimethyldodecanamide",3007-53-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8b52a90-d7cd-4fba-9d85-e15553674980/documents/a05ab0be-e7a0-416b-9c7a-b7c0b07a7b96_c0e9c3cf-1656-4da6-8c57-f88b716d5564.html,,inhalation,discriminating conc.,"3,551 mg/m3",no adverse effect observed, "N,N-dimethylglycinium chloride",2491-06-7," LD50 was considered to be 5400 mg/kg bw (95% confidential limit 4500 - 6400 mg/kg) for males and females,5800 mg/kg (95% confidential limit = 5100 – 6600 mg/kg) for males and 3900 mg/kg (95% confidential limit = 3000 - 5000 mg/kg) forfemales, when Crl:CD® BR male and female rats were treated with N,N-dimethylglycinium chloride orally by gavage. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d884cfe-048e-4c67-b2dc-acbd807a112b/documents/4a28e480-3696-49b3-8bab-32e4072a7037_88319c92-a44f-4ad3-bb56-9a85cda3a626.html,,,,,, "N,N-dimethylglycinium chloride",2491-06-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d884cfe-048e-4c67-b2dc-acbd807a112b/documents/4a28e480-3696-49b3-8bab-32e4072a7037_88319c92-a44f-4ad3-bb56-9a85cda3a626.html,,oral,LD50,"5,400 mg/kg bw",no adverse effect observed, "N,N-dimethylhydrazine",57-14-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1063a104-cd4a-4073-a11d-6c2d96156784/documents/4228c75f-690f-4752-a5a6-2de59b93df51_103bab5a-6396-4dbb-b9b0-06cd10d60b3b.html,,oral,LD50,122 mg/kg bw,, "N,N-dimethylhydrazine",57-14-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1063a104-cd4a-4073-a11d-6c2d96156784/documents/4228c75f-690f-4752-a5a6-2de59b93df51_103bab5a-6396-4dbb-b9b0-06cd10d60b3b.html,,dermal,LD50,"1,329 mg/kg bw",, "N,N-dimethylhydrazine",57-14-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1063a104-cd4a-4073-a11d-6c2d96156784/documents/4228c75f-690f-4752-a5a6-2de59b93df51_103bab5a-6396-4dbb-b9b0-06cd10d60b3b.html,,inhalation,LC50,630 mg/m3,, "N,N-dimethylisopropylamine",996-35-0,"A 7 days and 28 days inhalation reliable GLP OECD 412 studies are available for DMIPA (Rogers, 2021). No 90 days inhalation is available for DMIPA, however, a 90 days inhalation toxicity study is available for the analogue DMEA (Beebe, 2021) and is used as a  key study for DMIPA (see read across justification document). A two weeks preminary study for DMIPA for the oral route is available as a preliminary study to the OECD 421 by oral route. 1) 7-Day inhalation study with DMIPA The test item, N,N-Dimethylisopropylamine (DMIPA), was administered by nose-only inhalation administration to Wistar Han rats, for 6 hours a day, 5 days a week, for 1 week at achieved exposure levels of 12.2, 29.9, 107 or 497 ppm and was clinically well tolerated. Test item-related changes were evident in the nasal turbinates and larynx. Ulceration/erosion, hyperplasia, degeneration of the olfactory epithelium, inflammation and squamous metaplasia of the transitional and respiratory epithelium, marked inflammation/necrosis and septal perforation were observed in the nasal turbinates and squamous cell hyperplasia and minimal erosion in the larynx. These findings were seen at the highest incidence and severity in animals exposed to 497 ppm and were considered to be related to local irritation following the continuous inhalation administration of DMIPA for 6 hours per day for 5 days and were considered adverse. There were also test item-related effects on body weight and food consumption at 497 ppm in both sexes and males exposed to 29.9 or 107 ppm; with almost complete recovery at 29.9 or 107 ppm following two days without exposures. Test item-related clinical signs of salivation, chin rubbing and dry rales observed in animals exposed to 497 ppm were indicative of irritation.The findings observed at 497 ppm indicated this exposure level that was unsuitable for any longer term study. 2) 28 days inhalation study with DMIPA (Rogers, 2021) The test item N,N-Dimethylisopropylamine (DMIPA) was administered by snout-only inhalation administration to Wistar Han rats, for 6 hours a day, 5 days a week, for 4 weeks at achieved exposure levels of 12.1, 50.8 and 224 ppm and was clinically well tolerated, recovery was assessed during a 4 week off-dose period. There were no test item-related decedents on the study with minimal effects on body weight, food consumption, hematology and blood chemistry and organ weights. No effects were seen on clinical signs, ophthalmoscopy, bronchoalveolar lavage, sperm analysis or macroscopic pathology and the variations seen in the estrous cycles were questionable due to the lack of relevant historical control data, and the absence of correlation with any relevant changes in organ weights or microscopic findings in the ovaries and uterus as well as comparable  estrous profiles between treated groups and controls at the end of recovery period. Test-item related changes were evident in the nasal turbinates of animals exposed to 50.8 and 224 ppm and consisted of minimal to moderate atrophy of the olfactory epithelium and was associated with thinning of the mucosa and reduction or loss of adjacent axon bundles in the lamina propria. There was full recovery after 4 weeks without exposure to DMIPA; however, the incidence and severity of findings in the animals exposed to 224 ppm was considered adverse. Test-item related changes were also evident in the thymus of animals exposed to 224 ppm and consisted of minimal to slight increased lymphophatic apoptosis with full recovery after 4 weeks without exposure to DMIPA. This was considered to be non-adverse due to the minimal to slight severity. The No Observed Adverse Effect Concentration for systemic toxicity is considered to be 224 ppm based on the minimal effects seen on body weight, food consumption, hematology, blood chemistry and organ weights. The No Observed Adverse Effect Concentration for local effects is considered to be 50.8 ppm based on the histopathological findings seen in the nasal turbinates. 3. 90-day toxicity study by inhalation with analogue DMEA (Beebe, 2021) Four main groups of 10 male and 10 female Wistar Han rats each were exposed (nose-only) to target concentrations of 0 (control), 10, 30 or 100 ppm for 6 hours/day, 5 days/week over a 13-week period according to OECD 413 guideline and GLP. Animals of the main groups were sacrificed on the day after the last exposure. In addition, two recovery groups, also consisting of 10 male and 10 female animals each, were simultaneously exposed with the main study animals to the control or 100 ppm test atmosphere, and were sacrificed after a 6-week recovery period following the last exposure.Animals received the air control, or the test item, Dimethylethylamine by inhalation for 13 weeks. Recovery animals were similarly treated for 13 weeks followed by a 6 week off dose period. During the study, clinical condition, detailed physical and arena observations, sensory reactivity, grip strength, motor activity, estrous cycle, body weight, food consumption, ophthalmoscopy, hematology (peripheral blood), blood chemistry, thyroid hormone (T3 and T4), thyroid hormone (TSH), organ weight, sperm analysis, bronchoalveolar lavage, macropathology and histopathology investigations were undertaken. The mean achieved atmosphere concentrations were 10.3, 29.9 and 106 ppm (103, 100 and 106% of target) for Groups 2, 3 and 4, respectively and was clinically well tolerated, recovery was assessed during a 6 week off-dose period.  There were no test item-related deaths or effects on clinical signs, food consumption, sensory reactivity and grip strength or motor activity.  There were also no effects on ophthalmoscopy, haematology, blood chemistry, thyroid hormone levels, sperm motility, estrous cycle, bronchoalveolar lavage, organ weights or macroscopic pathology. Test item-related changes were evident in the nasal turbinates of animals exposed to 29.9 or 106 ppm and consisted of minimal to moderate degeneration/atrophy of the olfactory epithelium mainly affecting the dorsal parts of the nasal vestibules and was associated with loss of axon bundles in the sub adjacent lamina propria.  There was evidence of partial recovery after 6 weeks without exposure to DMEA; however, based on the incidence and severity these findings were considered adverse. Reduced body weight gain evident at the end of the treatment period for both sexes exposed to 106 ppm resolved following 6 weeks of recovery.  Based on the findings in this study a No Observed Adverse Effects Concentration (NOAEC) for the local toxicity is considered to be 10.3 ppm based on the minimal to moderate nasal degeneration/atrophy of the olfactory epithelium recorded at 29.9 or 106 ppm and the NOAEC for systemic toxicity is considered to be 106 ppm.   -14 days oral study with DMIPA (CRL, 2023) A 14-day Dose Range Finder (Test Facility Study No. 20417360) was conducted to selectdose levels for the Reproduction/Developmental Toxicity Screening Study (Test FacilityStudy No. 20417361), and to determine the peak effect of occurrence of clinical signs after dosing. No guidelines were applicable as this study was intended for dose level selection purposes only. Dose-levels of 100, 150 and 300 mg/kg/day were used. As a result of a high number of prematurely sacrified females at 150 and 300 mg/kg/day due to severe clinical signs, dose levels of 15, 45 and 100 mg/kg/day were selected for the OECD 421 study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/126796f5-2e83-420b-84e1-1ef29731d0b2/documents/IUC5-b25569d2-34d4-421b-a37b-1dd9007bc3c2_45a21167-cbb2-4452-b9a6-1bd5f3820752.html,,,,,, "N,N-dimethylisopropylamine",996-35-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/126796f5-2e83-420b-84e1-1ef29731d0b2/documents/IUC5-b25569d2-34d4-421b-a37b-1dd9007bc3c2_45a21167-cbb2-4452-b9a6-1bd5f3820752.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,318 mg/m3,,rat "N,N-dimethylisopropylamine",996-35-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/126796f5-2e83-420b-84e1-1ef29731d0b2/documents/IUC5-b25569d2-34d4-421b-a37b-1dd9007bc3c2_45a21167-cbb2-4452-b9a6-1bd5f3820752.html,Repeated dose toxicity – local effects,inhalation,LOAEC,30 mg/m3,adverse effect observed,rat "N,N-dimethylisopropylamine",996-35-0,"Dimethylisopropylamine is harmful by ingestion with an LD50 of 680 mg/kg in rats. A dermal LD0 higher than 200 mg/kg was reported in rabbits for DMIPA and LD0 higher than 2000 mg/kg was reported in rats for the analogue substances, dimethyl-n-propylamine . No relevant acute inhalation toxicity study is available on DMIPA. A 4-h LC50 in rats of 4.499 mg/L for the analogue substance, dimethyl-n-propylamine, allow to estimatethat DMIPA is toxic by inhalation exposure.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/126796f5-2e83-420b-84e1-1ef29731d0b2/documents/IUC5-c134bb9a-bf58-49b7-ac66-d06b6e989257_45a21167-cbb2-4452-b9a6-1bd5f3820752.html,,,,,, "N,N-dimethylisopropylamine",996-35-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/126796f5-2e83-420b-84e1-1ef29731d0b2/documents/IUC5-c134bb9a-bf58-49b7-ac66-d06b6e989257_45a21167-cbb2-4452-b9a6-1bd5f3820752.html,,oral,LD50,684 mg/kg bw,adverse effect observed, "N,N-dimethylisopropylamine",996-35-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/126796f5-2e83-420b-84e1-1ef29731d0b2/documents/IUC5-c134bb9a-bf58-49b7-ac66-d06b6e989257_45a21167-cbb2-4452-b9a6-1bd5f3820752.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N,N-dimethylisopropylamine",996-35-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/126796f5-2e83-420b-84e1-1ef29731d0b2/documents/IUC5-c134bb9a-bf58-49b7-ac66-d06b6e989257_45a21167-cbb2-4452-b9a6-1bd5f3820752.html,,inhalation,LC50,"4,499 mg/m3",adverse effect observed, "N,N-dimethyl-N'-(2,2,6,6-tetramethylpiperidin-4-yl)propane-1,3-diamine",78014-16-1,oral: LD50 is approx. 500 mg/kg bwdermal/inhalation: the study does not need to be conducted since the substance is classified as corrosive to the skin ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/525f33a7-dc21-4b74-86fb-ead1f1829905/documents/IUC5-505b1a34-c752-4af1-91f5-3f1888274c9b_1045a847-5626-4418-9dcd-09bc4a65692c.html,,,,,, "N,N-dimethyl-N'-(2,2,6,6-tetramethylpiperidin-4-yl)propane-1,3-diamine",78014-16-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/525f33a7-dc21-4b74-86fb-ead1f1829905/documents/IUC5-505b1a34-c752-4af1-91f5-3f1888274c9b_1045a847-5626-4418-9dcd-09bc4a65692c.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "N,N-dimethyloctanamide",1118-92-9,"Oral:Dog subchronic (13 weeks; gavage; mixture of N,N-dimethyldecanamide and N,N-dimethyloctanamide) NOAEL (systemic) = 200mg/kg bw/d; NOEL (local) = 40mg/kg bw/d (Bayer 2000, J. Ruf)Dermal: No reliable relevant studies available.Inhalation:No reliable relevant studies available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4a0d54a-5bf6-4f53-8f62-512f379655f2/documents/IUC5-6a4cfdbc-5140-4da1-a337-e382e93b2e4c_f267073e-4751-4eec-ada4-a6f2fedf4296.html,,,,,, "N,N-dimethyloctanamide",1118-92-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4a0d54a-5bf6-4f53-8f62-512f379655f2/documents/IUC5-6a4cfdbc-5140-4da1-a337-e382e93b2e4c_f267073e-4751-4eec-ada4-a6f2fedf4296.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,dog "N,N-dimethyloctanamide",1118-92-9,"Information drawn partly from experiments with a mixture of dimethylamides (mainly C8/C10):Acute oral toxicity (rat): LD50> 2000 mg/kg bw (Clariant 1993, Hoffmann) (C8/10)Acute dermal toxicity (rat): LD50 (male): > 2000 mg/kg bw (BASF SE 2012) (C8)Acute inhalation toxicity (rat): >3551 mg/m3 (Bayer 1991; J. Pauluhn) (C8/10) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4a0d54a-5bf6-4f53-8f62-512f379655f2/documents/IUC5-a68d4d11-3e2d-442b-a011-cb8f6ff1ee5d_f267073e-4751-4eec-ada4-a6f2fedf4296.html,,,,,, "N,N-dimethyloctanamide",1118-92-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4a0d54a-5bf6-4f53-8f62-512f379655f2/documents/IUC5-a68d4d11-3e2d-442b-a011-cb8f6ff1ee5d_f267073e-4751-4eec-ada4-a6f2fedf4296.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, "N,N-dimethyloctanamide",1118-92-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4a0d54a-5bf6-4f53-8f62-512f379655f2/documents/IUC5-a68d4d11-3e2d-442b-a011-cb8f6ff1ee5d_f267073e-4751-4eec-ada4-a6f2fedf4296.html,,dermal,discriminating dose,"2,000 mg/kg bw",adverse effect observed, "N,N-dimethyloctanamide",1118-92-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4a0d54a-5bf6-4f53-8f62-512f379655f2/documents/IUC5-a68d4d11-3e2d-442b-a011-cb8f6ff1ee5d_f267073e-4751-4eec-ada4-a6f2fedf4296.html,,inhalation,discriminating conc.,"3,551 mg/m3",no adverse effect observed, "N,N-dimethylpyridin-4-amine",1122-58-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/828d509b-4727-47ee-ba81-1286e8445780/documents/7a4d29ea-784c-4486-9725-678f908811f4_c5988447-8c13-4c71-ac01-864d9905a2a8.html,,oral,LD50,140 mg/kg bw,adverse effect observed, "N,N-dimethylpyridin-4-amine",1122-58-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/828d509b-4727-47ee-ba81-1286e8445780/documents/7a4d29ea-784c-4486-9725-678f908811f4_c5988447-8c13-4c71-ac01-864d9905a2a8.html,,dermal,LD50,90 mg/kg bw,adverse effect observed, "N,N-dimethylpyridin-4-amine",1122-58-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/828d509b-4727-47ee-ba81-1286e8445780/documents/7a4d29ea-784c-4486-9725-678f908811f4_c5988447-8c13-4c71-ac01-864d9905a2a8.html,,inhalation,LC50,0.53 mg/L,adverse effect observed, "N,N'-diphenylguanidine monohydrochloride",24245-27-0, The NOAEL in an oral repeated dose toxicity study with an structural analogue substance (CAS 102 -06 -7) was determined to be 10 mg/kg bw/d. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb9109be-31e3-441d-9269-1af3f75b5450/documents/33b0f980-94cc-4f42-bbae-fab55bac1de3_4185546d-3f76-454b-a6e1-92b396754155.html,,,,,, "N,N'-diphenylguanidine monohydrochloride",24245-27-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb9109be-31e3-441d-9269-1af3f75b5450/documents/33b0f980-94cc-4f42-bbae-fab55bac1de3_4185546d-3f76-454b-a6e1-92b396754155.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rabbit "N,N'-diphenylguanidine monohydrochloride",24245-27-0, Based on the results of an acute oral toxicity study with the test item according to OECD 423 the oral LD50 was determined to be: 50 mg/kg bw < LD50 > 300 mg/kg bw in female rats. Based on the results of an acute dermal toxicity study with a structural analogue substance (CAS 102 -06 -7) the dermal LD50 with the test item is considered to be > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb9109be-31e3-441d-9269-1af3f75b5450/documents/153f74ce-9be3-4014-93c0-ba1ad08c0087_4185546d-3f76-454b-a6e1-92b396754155.html,,,,,, "N,N'-diphenylguanidine monohydrochloride",24245-27-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb9109be-31e3-441d-9269-1af3f75b5450/documents/153f74ce-9be3-4014-93c0-ba1ad08c0087_4185546d-3f76-454b-a6e1-92b396754155.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N,N'-diphenyl-p-phenylenediamine",74-31-7," A repeated-dose 28-day oral toxicity study was performed in the course of the Safety Examination of Existing Chemicals in Japan. DPPD was applied to rats at 0, 100, 300 and 1000 mg/kg bw/d via gavage for 28 consecutive days. The 0 and 1000 mg/kg group, respectively, were observed for 14 days following the last application to evaluate recovery of effects. The only relevant findings were significantly reduced food consumpation during week 4 in the males of the 300 mg/k group and during weeks 3 and 4 in the males of the 1000 mg/kg group. However, this was not accompanied by any effects on body weight or body weight gain. In addition, total bilirubin was significantly increased in the males of all treatment groups at the end of the treatment period. This increase had reversed at the end of the recovery period. No histopathological correlates were found in the liver, and bilirubin or urobilirubinogen levels in urine did not increase. Therefore, the NOAEL in this study is 1000 mg/kg bw/d. In a long-term feeding study, Hasegawa et al. (1989) treated rats with DPPD via the diet (0.5 or 2% of DPPD) for 104 weeks. A LOAEL of 0.5% was observed in this study (corresponding to 194 mg/kg for males and to to 259 mg/kg for females). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8e1cbf4-a82b-4467-b376-6bafe1289e10/documents/94a2515f-ff49-49aa-861d-b6239518dc5c_eaf6a953-1073-4e9a-b23e-15851100a700.html,,,,,, "N,N'-diphenyl-p-phenylenediamine",74-31-7," In an acute oral toxicity study performed according to the Acute Toxic Class method, 2000 mg/kg of the test item N,N'-diphenyl-p-phenylenediamine (preparations in corn oil Ph.Eur.) were administered by gavage to two test groups of three fasted Wistar rats each (6 females). The body weights increased within the normal range throughout the study period. There were no macroscopic pathological findings at the end of the observation period. The acute oral LD50 was determined to be >2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8e1cbf4-a82b-4467-b376-6bafe1289e10/documents/505eefda-bac3-4040-b421-6a70d594e821_eaf6a953-1073-4e9a-b23e-15851100a700.html,,,,,, "N,N'-di-sec-butyl-p-phenylenediamine",101-96-2, Two subacute oral toxicity studies and one subchronic oral toxicity study were evaluated. The dose descriptor selected for the Chemical Safety Assessment is the NOAEL (3 mg/kg bw) deduced from the key subacute study. Only one dermal repeated dose toxicity study is available and was used for dermal - local and systemic effects ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8871e135-9114-46b0-9661-fa5a37de73d1/documents/IUC5-fc97f50c-53bd-4e17-a06a-1c1029a34a5d_745aced1-945e-431e-9879-aafb87d6af78.html,,,,,, "N,N'-di-sec-butyl-p-phenylenediamine",101-96-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8871e135-9114-46b0-9661-fa5a37de73d1/documents/IUC5-fc97f50c-53bd-4e17-a06a-1c1029a34a5d_745aced1-945e-431e-9879-aafb87d6af78.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,3 mg/kg bw/day,,rat "N,N'-di-sec-butyl-p-phenylenediamine",101-96-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8871e135-9114-46b0-9661-fa5a37de73d1/documents/IUC5-fc97f50c-53bd-4e17-a06a-1c1029a34a5d_745aced1-945e-431e-9879-aafb87d6af78.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,90 mg/kg bw/day,,rat "N,N'-di-sec-butyl-p-phenylenediamine",101-96-2," Two acute oral toxicity studies are available with a K2 score. Several K4 studies are available as well, but these were not taken into account for the risk assessent. Based on these studies an LD50 of 271 mg/kg bw was selected for further evaluation. With regard to the inhalation route of exposure, only limited (K4) information is available. However, as the information was consistent it was found suitable for use. Based on these studies an LD50 of 600 mg/m3 was selected for further evaluation. With regard to the dermal route of exposure there are again 2 K2 studies and several K4 studies. The evaluation is done based on the K2 studies leading to an LD50 of 756 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8871e135-9114-46b0-9661-fa5a37de73d1/documents/IUC5-baad2a89-97bb-4599-aa1b-03b8d512a4bc_745aced1-945e-431e-9879-aafb87d6af78.html,,,,,, "N,N'-di-sec-butyl-p-phenylenediamine",101-96-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8871e135-9114-46b0-9661-fa5a37de73d1/documents/IUC5-baad2a89-97bb-4599-aa1b-03b8d512a4bc_745aced1-945e-431e-9879-aafb87d6af78.html,,oral,LD50,271 mg/kg bw,adverse effect observed, "N,N'-di-sec-butyl-p-phenylenediamine",101-96-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8871e135-9114-46b0-9661-fa5a37de73d1/documents/IUC5-baad2a89-97bb-4599-aa1b-03b8d512a4bc_745aced1-945e-431e-9879-aafb87d6af78.html,,dermal,LD50,756 mg/kg bw,adverse effect observed, "N,N'-di-sec-butyl-p-phenylenediamine",101-96-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8871e135-9114-46b0-9661-fa5a37de73d1/documents/IUC5-baad2a89-97bb-4599-aa1b-03b8d512a4bc_745aced1-945e-431e-9879-aafb87d6af78.html,,inhalation,discriminating conc.,600 mg/m3,adverse effect observed, "N,N'-dithiodi-o-phenylenedibenzamide",135-57-9,"In a repeat dose dermal study, the NOAEL is considered to be > 800 mg/kg/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29ed5c7b-c984-497f-89e7-b917b45c7d01/documents/IUC5-ef240dbd-6d7a-431f-9031-02b8affb8d7f_129cbd02-f8f4-48ed-a301-71e21b7040ca.html,,,,,, "N,N'-dithiodi-o-phenylenedibenzamide",135-57-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29ed5c7b-c984-497f-89e7-b917b45c7d01/documents/IUC5-ef240dbd-6d7a-431f-9031-02b8affb8d7f_129cbd02-f8f4-48ed-a301-71e21b7040ca.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N,N'-dithiodi-o-phenylenedibenzamide",135-57-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29ed5c7b-c984-497f-89e7-b917b45c7d01/documents/IUC5-ef240dbd-6d7a-431f-9031-02b8affb8d7f_129cbd02-f8f4-48ed-a301-71e21b7040ca.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,800 mg/kg bw/day,,rat "N,N'-dithiodi-o-phenylenedibenzamide",135-57-9,Not found to be hazardous by ingestion or in contact with skin ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29ed5c7b-c984-497f-89e7-b917b45c7d01/documents/IUC5-6507a611-0889-4e78-a979-91325181a955_129cbd02-f8f4-48ed-a301-71e21b7040ca.html,,,,,, "N,N'-dithiodi-o-phenylenedibenzamide",135-57-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29ed5c7b-c984-497f-89e7-b917b45c7d01/documents/IUC5-6507a611-0889-4e78-a979-91325181a955_129cbd02-f8f4-48ed-a301-71e21b7040ca.html,,oral,discriminating dose,"5,050 mg/kg bw",no adverse effect observed, "N,N'-dithiodi-o-phenylenedibenzamide",135-57-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29ed5c7b-c984-497f-89e7-b917b45c7d01/documents/IUC5-6507a611-0889-4e78-a979-91325181a955_129cbd02-f8f4-48ed-a301-71e21b7040ca.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide)",123-26-2," The administration of Bisamid to Wistar rats by oral gavage at dose levels of 250, 500 and 1000 mg/kg body weight/day within the scope of OECD 422 revealed no treatment-related clinical signs, changes in the body weights or feed consumption. No treatment-related effects on reproduction/development such as mating index, fertility index, gestation length, post-natal loss, sex ratio and offspring growth and development. Macroscopic examination revealed no test item related findings in any of the animals of 250, 500 and 1000 mg/kg body weight body weight as group. No abnormality was observed attributable to test item in pups from all treatment groups. Microscopic examination revealed no abnormality attributable to test item - Bisamid at the highest dose tested i.e. 1000 mg/kg body weight. No Observed Effect Level (NOAEL) for Combined Repeated Dose Toxicity Study with Reproduction / Developmental Toxicity Screening Test: 1000 mg/kg body weight. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98e324ff-97b2-468d-bd08-a6fae5bd136a/documents/4eeffc44-bb35-4514-915c-2148b55a8cd1_a536a26b-ea35-423d-8faa-98ce3fe941d2.html,,,,,, "N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide)",123-26-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98e324ff-97b2-468d-bd08-a6fae5bd136a/documents/4eeffc44-bb35-4514-915c-2148b55a8cd1_a536a26b-ea35-423d-8faa-98ce3fe941d2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide)",123-26-2," Guidelined limit study for oral and inhalation route, wich revealed no adverse effects (LD50 > 2000 mg/kg bw and LC50 cut-off >4.88 mg/l air). The physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin. A in vivo study for dermal route is not reasonable. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98e324ff-97b2-468d-bd08-a6fae5bd136a/documents/3e23e34f-a2db-4883-9ee5-7daaa5c85cf6_a536a26b-ea35-423d-8faa-98ce3fe941d2.html,,,,,, "N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide)",123-26-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98e324ff-97b2-468d-bd08-a6fae5bd136a/documents/3e23e34f-a2db-4883-9ee5-7daaa5c85cf6_a536a26b-ea35-423d-8faa-98ce3fe941d2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N'-ethane-1,2-diylbis(12-hydroxyoctadecan-1-amide)",123-26-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98e324ff-97b2-468d-bd08-a6fae5bd136a/documents/3e23e34f-a2db-4883-9ee5-7daaa5c85cf6_a536a26b-ea35-423d-8faa-98ce3fe941d2.html,,inhalation,LC50,5 ,adverse effect observed, "N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)",32588-76-4,"Two repeated dose toxicity studies are available, a 28-day and a 90-day dietary study in rats at dose levels up to the limit dose of 1000 mg/kg body weight per day. No treatment related adverse effects were observed in both studies up to the highest dose tested. The NOAEL is consequently > 1000 mg/kg bw. The studies confirm the low bioavailability of the substance as also demonstrated in the toxicokinetic study. Due to the low water and anticipated low lipid solubility it can reasonably assumed that the substance is unlikely to exert adverse effects by other routes of exposure or studies of longer duration. Due to the absence of effects at the limit dose of 1000 mg/kg bw in both repeated dose and developmental toxicity studies, the derivation of DNEL values for repeated dose toxicity is not warranted according to the ECHA guidance on information requirements, Part B, version 2.1, 2011. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The overall data base with a subacute, a subchronic, two developmental toxicity studies in two species as well as a toxicokinetic study allows the conclusion that the substance has a low hazard potential after repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86a011ec-42ac-459d-ada7-49c7d6127283/documents/IUC5-fd68d87a-5a46-4e0b-a068-1d12c9f88a3d_5a497ac6-7fa7-45bb-a549-85cfd2c01501.html,,,,,, "N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)",32588-76-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86a011ec-42ac-459d-ada7-49c7d6127283/documents/IUC5-fd68d87a-5a46-4e0b-a068-1d12c9f88a3d_5a497ac6-7fa7-45bb-a549-85cfd2c01501.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)",32588-76-4,"oral: rat, similar to OECD 420, gavage, LD0 = 7500 mg/kg bw/d, LD50 > 7500 mg/kg bw/d inhalation: rat, similar to EPA OPPTS 870.1300, GLP, 1 h whole body, LC0 = 203 mg/L, LC50> 203 mg/L dermal: rabbit, similar to OECD 434, 24 h occlusive, LD0 = 2000 mg/kg bw/d, LD50 > 2000 mg/kg bw/d Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study consisted of an adequate number of animals administered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): This study was performed according to Good Laboratory Practices.   Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study consisted of an adequate number of animals administered a limit dose. The methodology is consistent with current guidelines. The study was performed prior to established guidelines and GLPs. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86a011ec-42ac-459d-ada7-49c7d6127283/documents/IUC5-23f071c1-8a51-45a1-b4f3-fb59fb7d14d3_5a497ac6-7fa7-45bb-a549-85cfd2c01501.html,,,,,, "N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)",32588-76-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86a011ec-42ac-459d-ada7-49c7d6127283/documents/IUC5-23f071c1-8a51-45a1-b4f3-fb59fb7d14d3_5a497ac6-7fa7-45bb-a549-85cfd2c01501.html,,oral,LD0,"7,500 mg/kg bw",no adverse effect observed, "N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)",32588-76-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86a011ec-42ac-459d-ada7-49c7d6127283/documents/IUC5-23f071c1-8a51-45a1-b4f3-fb59fb7d14d3_5a497ac6-7fa7-45bb-a549-85cfd2c01501.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, "N,N'-ethylenebis(3,4,5,6-tetrabromophthalimide)",32588-76-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86a011ec-42ac-459d-ada7-49c7d6127283/documents/IUC5-23f071c1-8a51-45a1-b4f3-fb59fb7d14d3_5a497ac6-7fa7-45bb-a549-85cfd2c01501.html,,inhalation,LC0,"203,000 mg/m3",no adverse effect observed, "N,N'-hexamethylenebis(cinnamylideneamine)",140-73-8, Acute Oral Toxicity LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26b0ddcf-211b-46bc-9db9-5e49d09124ce/documents/04df4e94-41d9-4442-8435-fde68f7bf1c2_5f31103a-7513-470a-90a8-2032a8b19d9e.html,,,,,, "N,N'-hexamethylenebis(cinnamylideneamine)",140-73-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26b0ddcf-211b-46bc-9db9-5e49d09124ce/documents/04df4e94-41d9-4442-8435-fde68f7bf1c2_5f31103a-7513-470a-90a8-2032a8b19d9e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N'-hexane-1,6-diylbis(hexahydro-2-oxo-1H-azepine-1-carboxamide)",5888-87-9,NOAEL (28 days) > 1000 mg/kg bw ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3e857d6-c6d0-4166-b3e6-d76b4f09d82d/documents/IUC5-9cc5e66e-9680-482c-99e4-a643320069e8_f70f7567-61cd-4f43-8ae1-0049ff75ad16.html,,,,,, "N,N'-hexane-1,6-diylbis(hexahydro-2-oxo-1H-azepine-1-carboxamide)",5888-87-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3e857d6-c6d0-4166-b3e6-d76b4f09d82d/documents/IUC5-9cc5e66e-9680-482c-99e4-a643320069e8_f70f7567-61cd-4f43-8ae1-0049ff75ad16.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N,N'-hexane-1,6-diylbis(hexahydro-2-oxo-1H-azepine-1-carboxamide)",5888-87-9," LD50(oral) > 2,000 mg/kg LD50(dermal) > 2,000 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3e857d6-c6d0-4166-b3e6-d76b4f09d82d/documents/IUC5-f78b69d8-2474-4267-8286-00799d15191e_f70f7567-61cd-4f43-8ae1-0049ff75ad16.html,,,,,, "N,N'-hexane-1,6-diylbis(hexahydro-2-oxo-1H-azepine-1-carboxamide)",5888-87-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3e857d6-c6d0-4166-b3e6-d76b4f09d82d/documents/IUC5-f78b69d8-2474-4267-8286-00799d15191e_f70f7567-61cd-4f43-8ae1-0049ff75ad16.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N'-hexane-1,6-diylbis(hexahydro-2-oxo-1H-azepine-1-carboxamide)",5888-87-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3e857d6-c6d0-4166-b3e6-d76b4f09d82d/documents/IUC5-f78b69d8-2474-4267-8286-00799d15191e_f70f7567-61cd-4f43-8ae1-0049ff75ad16.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide]",23128-74-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55cf6774-e6ef-4b16-94ae-876ebc66f71e/documents/IUC5-1b2b7076-56e9-422c-bc4b-816706e295dd_773c7000-d966-4300-917e-2ee5f9de696d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,dog "N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide]",23128-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55cf6774-e6ef-4b16-94ae-876ebc66f71e/documents/IUC5-f76bb486-5d17-4fe5-9c2a-c058e04635f5_773c7000-d966-4300-917e-2ee5f9de696d.html,,oral,LD50,"7,750 mg/kg bw",no adverse effect observed, "N,N'-hexane-1,6-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenylpropionamide]",23128-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55cf6774-e6ef-4b16-94ae-876ebc66f71e/documents/IUC5-f76bb486-5d17-4fe5-9c2a-c058e04635f5_773c7000-d966-4300-917e-2ee5f9de696d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N,N''-hexane-1,6-diylbis[N'-benzylurea]",39072-70-3,"OECD 422: NOAEL = 1000 mg/kg bw/day (WIL Research Europe, 2013) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76a9b9f7-df2f-4e3a-b6f6-4d4828b17a6e/documents/IUC5-25513a3e-52b0-4e78-9095-7cf542e79e00_0434330f-04f5-4740-b33c-3480c9da6b27.html,,,,,, "N,N''-hexane-1,6-diylbis[N'-benzylurea]",39072-70-3,"LD50(oral) > 2000 mg/kg bw. (Bioassay, 2012)LD50(dermal) > 2000 mg/kg bw. (Bioassay, 2012) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76a9b9f7-df2f-4e3a-b6f6-4d4828b17a6e/documents/IUC5-b915048c-02f6-46e5-a003-08c74bab868b_0434330f-04f5-4740-b33c-3480c9da6b27.html,,,,,, "N,N'-methylenedistearamide",109-23-9," - Oral: discriminating dose >2000 mg/kg, female Wistar rat, OECD 420, Envigo Research Limited, 2018. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/887179ce-bc61-49cb-ae50-46312937f08f/documents/6d02da9a-e9f5-47e7-a272-71a0cc8b1bfd_6be41de1-54bd-498b-8147-a3ab81a10eb4.html,,,,,, "N,N'-methylenedistearamide",109-23-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/887179ce-bc61-49cb-ae50-46312937f08f/documents/6d02da9a-e9f5-47e7-a272-71a0cc8b1bfd_6be41de1-54bd-498b-8147-a3ab81a10eb4.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N,N'-naphthalene-1,5-diylbis[4-[(2,3-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",68516-75-6,"Oral route: Structural analogues (disazo condensation red pigments) did not cause treatment-related adverse effects up to the limit dose upon subacute oral exposure. This assessment is based on a GLP and OECD 407 compliant study with analogue substance Pigment Red 166 (CAS 3905-19-9) (Vuos 2009b) and a GLP and OECD 422 compliant study with analogue substance Pigment Red 220 (CAS 68259-05-2) (BASF 2012b). Inhalation route: Based on results of a OECD 412 repeated inhalation study, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of the registered substance was found to be 0.03 mg/L when exposed for 6 hours/day, 5 days/week, for 4 weeks by flow-past nose-only inhalation route to Sprague Dawley rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): reliable without restriction Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): reliable without restriction Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Valid without restriction ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6faa9d43-33c7-428f-a3b7-ebc95d3c320d/documents/d1c6b8ce-7537-46c2-a6d5-1c31ff310b0e_e41a23fd-79a0-4ccf-a1f5-00ce6631b0c3.html,,,,,, "N,N'-naphthalene-1,5-diylbis[4-[(2,3-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",68516-75-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6faa9d43-33c7-428f-a3b7-ebc95d3c320d/documents/d1c6b8ce-7537-46c2-a6d5-1c31ff310b0e_e41a23fd-79a0-4ccf-a1f5-00ce6631b0c3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N,N'-naphthalene-1,5-diylbis[4-[(2,3-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",68516-75-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6faa9d43-33c7-428f-a3b7-ebc95d3c320d/documents/d1c6b8ce-7537-46c2-a6d5-1c31ff310b0e_e41a23fd-79a0-4ccf-a1f5-00ce6631b0c3.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,0.03 mg/L,,rat "N,N'-naphthalene-1,5-diylbis[4-[(2,3-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",68516-75-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6faa9d43-33c7-428f-a3b7-ebc95d3c320d/documents/d1c6b8ce-7537-46c2-a6d5-1c31ff310b0e_e41a23fd-79a0-4ccf-a1f5-00ce6631b0c3.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.03 mg/L,no adverse effect observed,rat "N,N'-naphthalene-1,5-diylbis[4-[(2,3-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",68516-75-6,"The structural analogue Pigment Red 242 (nano form) was found to be non toxic upon acute oral toxicity in rats treated with 2000 mg/kg bw. In addition, the structural analogue Pigment Red 144 showed no acute dermal toxicity in rabbits up to 2000 mg/kg bw. This observation is supported by the physico-chemical properties which indicate absent or very low skin permeability. Regarding inhalation toxicity the structural analogue Pigment Red 220 was found to be non toxic in rat exposed with whole body 4 h with up to 2200 mg/m³ air.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable and valid. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): reliable and valid ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6faa9d43-33c7-428f-a3b7-ebc95d3c320d/documents/94104f16-d575-4a49-beb3-6d43c5b192df_e41a23fd-79a0-4ccf-a1f5-00ce6631b0c3.html,,,,,, "N,N'-naphthalene-1,5-diylbis[4-[(2,3-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",68516-75-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6faa9d43-33c7-428f-a3b7-ebc95d3c320d/documents/94104f16-d575-4a49-beb3-6d43c5b192df_e41a23fd-79a0-4ccf-a1f5-00ce6631b0c3.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "N,N'-naphthalene-1,5-diylbis[4-[(2,3-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",68516-75-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6faa9d43-33c7-428f-a3b7-ebc95d3c320d/documents/94104f16-d575-4a49-beb3-6d43c5b192df_e41a23fd-79a0-4ccf-a1f5-00ce6631b0c3.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "N,N'-naphthalene-1,5-diylbis[4-[(2,3-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",68516-75-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6faa9d43-33c7-428f-a3b7-ebc95d3c320d/documents/94104f16-d575-4a49-beb3-6d43c5b192df_e41a23fd-79a0-4ccf-a1f5-00ce6631b0c3.html,,inhalation,LC50,> 2.2 mg/L,no adverse effect observed, "N,N''-naphthalene-1,5-diylbis[N'-[3-[(2-ethylhexyl)oxy]propyl]urea]",71216-01-8, The substance caused no adverse effects at 1000 mg/kg bw in a GLP- and OECD 422 compliant study in rats. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43ec906f-f636-4924-9663-bc5eea69071f/documents/IUC5-f4fa8bca-4cc4-4cb6-897b-5e8e3e5ecccd_afe1275f-e244-48a9-81f3-5fc69166488d.html,,,,,, "N,N''-naphthalene-1,5-diylbis[N'-[3-[(2-ethylhexyl)oxy]propyl]urea]",71216-01-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/43ec906f-f636-4924-9663-bc5eea69071f/documents/IUC5-f4fa8bca-4cc4-4cb6-897b-5e8e3e5ecccd_afe1275f-e244-48a9-81f3-5fc69166488d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N,N''-naphthalene-1,5-diylbis[N'-[3-[(2-ethylhexyl)oxy]propyl]urea]",71216-01-8, No indication of toxicity was observed in the acute oral and dermal toxicity study in rats at limit doses. Also intradermal injection of 2000 mg/kg did not show significant adverse toxicity in mice. Studies are adequate in design and reporting for the purpose of classification and labelling. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43ec906f-f636-4924-9663-bc5eea69071f/documents/IUC5-e26862bc-ea52-4ee8-a93d-27484eda6bd1_afe1275f-e244-48a9-81f3-5fc69166488d.html,,,,,, "N,N''-naphthalene-1,5-diylbis[N'-[3-[(2-ethylhexyl)oxy]propyl]urea]",71216-01-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43ec906f-f636-4924-9663-bc5eea69071f/documents/IUC5-e26862bc-ea52-4ee8-a93d-27484eda6bd1_afe1275f-e244-48a9-81f3-5fc69166488d.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "N,N''-naphthalene-1,5-diylbis[N'-[3-[(2-ethylhexyl)oxy]propyl]urea]",71216-01-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43ec906f-f636-4924-9663-bc5eea69071f/documents/IUC5-e26862bc-ea52-4ee8-a93d-27484eda6bd1_afe1275f-e244-48a9-81f3-5fc69166488d.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",3905-19-9,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyInformation.KeyInformation): Oral: NOAEL (male) = 400 mg/kg bw/d, NOAEL (female) = 1000 mg/kg bw/d, according to OECD 407, GLP, 28 d exposure, rat, 2009, K2 Inhalation: NOAEC (local effects) = 4.9 mg/m³ air, NOAEC (systemic effects) ≥ 60.4 mg/m³ air, no guideline, GLP, 5 d exposure, rat, 2022, K1Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Valid without restriction ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c099c362-bfcb-4835-a914-904988070573/documents/a61fba85-bc1f-42c4-8c4d-503fdb1a1f24_609db63b-30ca-4f0d-a17a-c05896c46e7a.html,,,,,, "N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",3905-19-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c099c362-bfcb-4835-a914-904988070573/documents/a61fba85-bc1f-42c4-8c4d-503fdb1a1f24_609db63b-30ca-4f0d-a17a-c05896c46e7a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat "N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",3905-19-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c099c362-bfcb-4835-a914-904988070573/documents/a61fba85-bc1f-42c4-8c4d-503fdb1a1f24_609db63b-30ca-4f0d-a17a-c05896c46e7a.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,60.4 mg/m3,,rat "N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",3905-19-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c099c362-bfcb-4835-a914-904988070573/documents/a61fba85-bc1f-42c4-8c4d-503fdb1a1f24_609db63b-30ca-4f0d-a17a-c05896c46e7a.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4.9 mg/m3,no adverse effect observed, "N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",3905-19-9,"- Oral: LD50 > 15000 mg/kg bw, rat, comparable to OECD TG 401, no GLP, 1975, K2 - Inhalation: LC50 > 2.002 mg/L air, rat, according to OECD TG 403, GLP compliant, 2022, K1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c099c362-bfcb-4835-a914-904988070573/documents/2542f7cf-ae6a-4298-b96e-2af6064a0571_609db63b-30ca-4f0d-a17a-c05896c46e7a.html,,,,,, "N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",3905-19-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c099c362-bfcb-4835-a914-904988070573/documents/2542f7cf-ae6a-4298-b96e-2af6064a0571_609db63b-30ca-4f0d-a17a-c05896c46e7a.html,,oral,discriminating dose,"> 15,000 mg/kg bw",no adverse effect observed, "N,N'-phenylene-1,4-bis[4-[(2,5-dichlorophenyl)azo]-3-hydroxynaphthalene-2-carboxamide]",3905-19-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c099c362-bfcb-4835-a914-904988070573/documents/2542f7cf-ae6a-4298-b96e-2af6064a0571_609db63b-30ca-4f0d-a17a-c05896c46e7a.html,,inhalation,discriminating conc.,> 2.002 mg/L,, "N,N'-propane-1,3-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide]",69851-61-2, 13-Week dog feeding study NOAEL: 200000 ppm (787 mg/kg/day; highest dose tested) for read-across substance; equivalent to OECD 409; Reliability = 2 ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7424f78f-1c32-41d9-8417-174606e78d7a/documents/d940d1ed-af90-43bf-9612-d1d564138064_c580aef0-74ac-41a4-b109-5ba2840cd51d.html,,,,,, "N,N'-propane-1,3-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide]",69851-61-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7424f78f-1c32-41d9-8417-174606e78d7a/documents/d940d1ed-af90-43bf-9612-d1d564138064_c580aef0-74ac-41a4-b109-5ba2840cd51d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,787 mg/kg bw/day,,dog "N,N'-propane-1,3-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide]",69851-61-2, Oral: Scientifically valid study; rat LC50 >10000 mg/kg. Reliability = 2 Inhalation: No study available Dermal: equivalent to OECD 402; rat LD50 >2000 mg/kg for read-across substance. Reliability = 2 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7424f78f-1c32-41d9-8417-174606e78d7a/documents/4dee6699-2eeb-450e-8675-43fc25a48c43_c580aef0-74ac-41a4-b109-5ba2840cd51d.html,,,,,, "N,N'-propane-1,3-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide]",69851-61-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7424f78f-1c32-41d9-8417-174606e78d7a/documents/4dee6699-2eeb-450e-8675-43fc25a48c43_c580aef0-74ac-41a4-b109-5ba2840cd51d.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "N,N'-propane-1,3-diylbis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionamide]",69851-61-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7424f78f-1c32-41d9-8417-174606e78d7a/documents/4dee6699-2eeb-450e-8675-43fc25a48c43_c580aef0-74ac-41a4-b109-5ba2840cd51d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N-[(1,1,3,3-tetramethylbutyl)phenyl]naphthalen-1-amine",51772-35-1,"- Short-term: Combined repeated dose (28-d) toxicity and reproduction/developmental screening study, according to OECD TG 422 and GLP, rat, oral gavage, NOAEL 1000 mg/kg bw/d (male/female) - Sub-chronic: Repeated dose (90-d) toxicity study, according to OECD TG 408 and GLP, rat, oral gavage, NOAEL 100 mg/kg bw/d (male), NOAEL 300 mg/kg bw/d (female) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c0000a4-be15-4e1e-8b78-e4f7ea2d8245/documents/IUC5-b26ba37a-e55b-4163-9d3f-11d5d32d906f_2655e804-8757-4361-9f10-723e8e014f65.html,,,,,, "N-[(1,1,3,3-tetramethylbutyl)phenyl]naphthalen-1-amine",51772-35-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c0000a4-be15-4e1e-8b78-e4f7ea2d8245/documents/IUC5-b26ba37a-e55b-4163-9d3f-11d5d32d906f_2655e804-8757-4361-9f10-723e8e014f65.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N-[(1,1,3,3-tetramethylbutyl)phenyl]naphthalen-1-amine",51772-35-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c0000a4-be15-4e1e-8b78-e4f7ea2d8245/documents/IUC5-b26ba37a-e55b-4163-9d3f-11d5d32d906f_2655e804-8757-4361-9f10-723e8e014f65.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "N-[(1,1,3,3-tetramethylbutyl)phenyl]naphthalen-1-amine",51772-35-1,"- Oral: According to OECD TG 423 and GLP, limit test, no mortality observed, LD50 >2000 mg/kg bw - Dermal: According to OECD TG 402, GLP, limit test, no mortality observed, LD50 >2000 mg/kg bw - Inhalation: No reliable data available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c0000a4-be15-4e1e-8b78-e4f7ea2d8245/documents/IUC5-94bc56b6-a47a-4110-8c96-ba527683474e_2655e804-8757-4361-9f10-723e8e014f65.html,,,,,, "N-[(1,1,3,3-tetramethylbutyl)phenyl]naphthalen-1-amine",51772-35-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c0000a4-be15-4e1e-8b78-e4f7ea2d8245/documents/IUC5-94bc56b6-a47a-4110-8c96-ba527683474e_2655e804-8757-4361-9f10-723e8e014f65.html,,oral,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, "N-[(1,1,3,3-tetramethylbutyl)phenyl]naphthalen-1-amine",51772-35-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c0000a4-be15-4e1e-8b78-e4f7ea2d8245/documents/IUC5-94bc56b6-a47a-4110-8c96-ba527683474e_2655e804-8757-4361-9f10-723e8e014f65.html,,dermal,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, N-[(2-methylpropoxy)methyl]acrylamide,16669-59-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/619c05c4-bcbb-4b5e-b06b-7ce5e2115cc9/documents/0001cc3f-e2cc-43ff-ba25-c3392d2dbfaa_87cc849a-e4c0-4d06-872e-350d11cea590.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,677 mg/kg bw/day,,rat N-[(2-methylpropoxy)methyl]acrylamide,16669-59-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/619c05c4-bcbb-4b5e-b06b-7ce5e2115cc9/documents/52964b29-0ec3-4904-bbcf-86f52cb1178b_87cc849a-e4c0-4d06-872e-350d11cea590.html,,oral,LD50,"1,180 mg/kg bw",adverse effect observed, "N-[[3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]carbamoyl]-2,6-difluorobenzamide",121451-02-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1037b9ed-d8aa-462a-8d85-081998282a29/documents/a7e7f700-8f37-4b8a-b5e0-9a2e06c7af26_3d43fb8f-fccf-4a94-8432-db559b68d45b.html,Chronic toxicity – systemic effects,oral,NOAEL,1 mg/kg bw/day,,rat "N-[[3,5-dichloro-2-fluoro-4-(1,1,2,3,3,3-hexafluoropropoxy)phenyl]carbamoyl]-2,6-difluorobenzamide",121451-02-3,"The key study was conducted under GLP conditions and followed standardised guidelines, producing reliable and conclusive results. The study was assigned a reliability score of 1, reliable without restrictions, in line with the principles of Klimisch et al (1997). A supporting study is also available. This was performed in accordance with generally accepted scientific principles, with incomplete reporting that did not affect the quality of the relevant results. This study was assigned a reliability score of 2, reliable with restrictions. The overall quality of the database is considered to be high. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1037b9ed-d8aa-462a-8d85-081998282a29/documents/57bc34ec-5da5-46ee-856b-e7f1e859e9af_3d43fb8f-fccf-4a94-8432-db559b68d45b.html,,,,,, "N-[1,1'-Biphenyl]-2-yl-N-[1,1'-biphenyl]-4-yl-9,9'-spirobi[9H-fluoren]-2-amine",1364602-80-1, GLP compliant OECD 423: LD50 (oral) > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4799513-e965-4433-b5f9-c794d6e7e04b/documents/d4fb3bb5-97ce-400b-a1f5-1cc126a442a8_b43fbb5f-12a1-4329-b7c2-c9c9ea7f2ec7.html,,,,,, "N-[1,1'-Biphenyl]-2-yl-N-[1,1'-biphenyl]-4-yl-9,9'-spirobi[9H-fluoren]-2-amine",1364602-80-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4799513-e965-4433-b5f9-c794d6e7e04b/documents/d4fb3bb5-97ce-400b-a1f5-1cc126a442a8_b43fbb5f-12a1-4329-b7c2-c9c9ea7f2ec7.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)-phenyl-aminocarbonyl]-2,6-difluorobenzamide",103055-07-8," - Oral: NOAEL = 1.93 and 2.34 mg/kg bw/day for males and females, respectively, rats, chronic, 24 months dietary, Bachmann 1993.  - Dermal: NOAEL > 1000 mg/kg bw/day for males and female, rats, sub-acute, 28 days, occlusive dressing, Schneider 1990 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea315b21-599c-478c-a95e-3dd2816f7ac8/documents/f948a953-f08c-4873-aa30-2a9cc9b890a4_4a99d8d5-0797-459a-8328-63f47f895fa6.html,,,,,, "N-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)-phenyl-aminocarbonyl]-2,6-difluorobenzamide",103055-07-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea315b21-599c-478c-a95e-3dd2816f7ac8/documents/f948a953-f08c-4873-aa30-2a9cc9b890a4_4a99d8d5-0797-459a-8328-63f47f895fa6.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "N-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)-phenyl-aminocarbonyl]-2,6-difluorobenzamide",103055-07-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea315b21-599c-478c-a95e-3dd2816f7ac8/documents/f948a953-f08c-4873-aa30-2a9cc9b890a4_4a99d8d5-0797-459a-8328-63f47f895fa6.html,Chronic toxicity – systemic effects,oral,NOAEL,1.93 mg/kg bw/day,,rat "N-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)-phenyl-aminocarbonyl]-2,6-difluorobenzamide",103055-07-8," - Oral: LD50 > 2000 mg/kg bw, males/females, rat, according to OECD TG 401, Hartmann, 1988. - Inhalation: LC50 > 2350 mg/m3, males/female, rat, according to OECD TG 403, Hartmann, 1988. - Dermal: LD50 > 2000 mg/kg bw, males/females, rat, equivalent to OECD TG 402, Hartmann, 1988. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea315b21-599c-478c-a95e-3dd2816f7ac8/documents/efd62a0a-2dda-4532-9875-cedc851d207d_4a99d8d5-0797-459a-8328-63f47f895fa6.html,,,,,, "N-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)-phenyl-aminocarbonyl]-2,6-difluorobenzamide",103055-07-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea315b21-599c-478c-a95e-3dd2816f7ac8/documents/efd62a0a-2dda-4532-9875-cedc851d207d_4a99d8d5-0797-459a-8328-63f47f895fa6.html,,oral,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, "N-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)-phenyl-aminocarbonyl]-2,6-difluorobenzamide",103055-07-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea315b21-599c-478c-a95e-3dd2816f7ac8/documents/efd62a0a-2dda-4532-9875-cedc851d207d_4a99d8d5-0797-459a-8328-63f47f895fa6.html,,dermal,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, "N-[2,5-dichloro-4-(1,1,2,3,3,3-hexafluoropropoxy)-phenyl-aminocarbonyl]-2,6-difluorobenzamide",103055-07-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea315b21-599c-478c-a95e-3dd2816f7ac8/documents/efd62a0a-2dda-4532-9875-cedc851d207d_4a99d8d5-0797-459a-8328-63f47f895fa6.html,,inhalation,discriminating conc.,">=2,350 mg/m3",no adverse effect observed, "N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diallylamino)-4-methoxyphenyl]acetamide",51868-46-3," No adverse effects were observed that could be related to the treatment with the test substance. Under the study conditions, the NOEL was greater than the highest dose tested and determined to be >2500 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce2ddd40-526f-4283-9b06-0fae211d409d/documents/2b58c625-2095-462e-8e9b-be4a0a51339f_9e931c46-54cc-454e-9542-3fefa1c8d2c5.html,,,,,, "N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diallylamino)-4-methoxyphenyl]acetamide",51868-46-3, The substance is practically nontoxic; no adverse effects were noted in acute toxicity studies up to the highest dose level administered. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce2ddd40-526f-4283-9b06-0fae211d409d/documents/d30b4d4a-0db8-4d71-8967-f5c16efbddda_9e931c46-54cc-454e-9542-3fefa1c8d2c5.html,,,,,, "N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide",52697-38-8," No adverse effects were observed that could be related to the treatment with the test substance. Under the study conditions, the NOEL was greater than the highest dose tested and determined to be >2500 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2118f30-0cab-4b41-a404-4078d9240a2c/documents/cd837058-d87c-461f-8ffa-9c59efeef35d_1cfd4316-277c-4d8d-88e2-17a828d6cbcc.html,,,,,, "N-[2-[(2-bromo-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide",52697-38-8, The substance shows a low toxicity. The oral LD50 lies above 5000 mg/kh body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2118f30-0cab-4b41-a404-4078d9240a2c/documents/49bfc810-4b35-4b6a-969e-16bb642dcae7_1cfd4316-277c-4d8d-88e2-17a828d6cbcc.html,,,,,, "N-[2-[(2-chloro-4,6-dinitrophenyl)azo]-5-(diallylamino)-4-methoxyphenyl]acetamide",85508-41-4," No adverse effects were observed that could be related to the treatment with the test substance. Under the study conditions, the NOEL was greater than the highest dose tested and determined to be >2500 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7361f380-1771-40c3-8e78-3c104806269b/documents/a9bfaa17-49d7-4023-9ade-d1df6d7af10a_c914fdc1-6474-4e3e-ad96-41c4a972593c.html,,,,,, "N-[2-[(2-chloro-4,6-dinitrophenyl)azo]-5-(diallylamino)-4-methoxyphenyl]acetamide",85508-41-4, LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7361f380-1771-40c3-8e78-3c104806269b/documents/0ceb44d5-0dbb-4dab-b5aa-3fae4d7068b1_c914fdc1-6474-4e3e-ad96-41c4a972593c.html,,,,,, "N-[2-[(2-chloro-4,6-dinitrophenyl)azo]-5-(diallylamino)-4-methoxyphenyl]acetamide",85508-41-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7361f380-1771-40c3-8e78-3c104806269b/documents/0ceb44d5-0dbb-4dab-b5aa-3fae4d7068b1_c914fdc1-6474-4e3e-ad96-41c4a972593c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N-[2-[(2-chloro-4,6-dinitrophenyl)azo]-5-(diethylamino)-4-methoxyphenyl]acetamide",79295-99-1, LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8023c85-aa92-4eb1-83e3-73bf117c6261/documents/1f72bf53-164f-444a-abaf-9f917f583f5d_78c9e1ef-1301-4082-a007-820e681b1584.html,,,,,, "N-[2-[(2-chloro-4,6-dinitrophenyl)azo]-5-(diethylamino)-4-methoxyphenyl]acetamide",79295-99-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8023c85-aa92-4eb1-83e3-73bf117c6261/documents/1f72bf53-164f-444a-abaf-9f917f583f5d_78c9e1ef-1301-4082-a007-820e681b1584.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N-[2-[(2-chloro-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide",66557-45-7," The LD50 in rat (male/female, oral, gavage) was determined >5000 mg/kg bw for the target Disperse Violet 93.1 Br. Disperse Violet 93.1 Cl is not considered to be acutely toxic either. The substance is not classifiable according to CLP criteria. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92221092-55a8-4c40-b417-2899875f13a5/documents/0b7105bd-0744-40a1-bdca-801e945b942e_667440be-6545-4666-9e80-ea406e17d430.html,,,,,, "N-[2-[(2-cyano-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide",24170-60-3,"Acute Oral Toxicity Study: FAT 36156/D was assessed for acute toxicity potential via ora route according to OECD Guideline 420 and EU Method B.1. Following a sighting test at a dose level of 2000 mg/kg bw, an additional four fasted female animals were given a single oral dose of test item, as a suspension in arachis oil BP, at a dose level of 2000 mg/kg bw. Clinical signs and body weight development were monitored during the study. All animals were subjected to gross necropsy. There were no deaths and no signs of systemic toxicity. However, green stained feces were noted in the initial treated animal. Animals showed expected gains in body weight, except for one animal which showed expected gain in body weight during the first week but body weight loss during the second week. No abnormalities were noted at necropsy.In conclusion, the acute oral median lethal dose (LD50) of FAT 36156/D in the female Wistar rat was estimated to be greater than 2000 mg/kg bw. In a supporting study, FAT 36156/A was assessed for acute toxicity potential via oral route in albino rats. The study was carried out according to the OECD Guideline 401. Five rats per sex were used at each dose of 2000 and 5000 mg/kg bw. No mortality was seen at 2000 mg/kg bw, however 3 males and 2 females at 5000 mg/kg bw were found dead on Day 1. Hence, the acute oral median lethal dose (LD50) in rats was greater than 2000 mg/kg bw.     Acute Inhalation Toxicity Study: Currently no study to assess the acute inhalation toxicity potential of Disperse Blue 165:1 is available. However, the vapour pressure for the substance can be considered low (2.2 x 10-11Pa). Hence, the substance is considered to have low volatility. Synthesis and spray drying of this chemical is performed in a closed process; the final product consists of non-dusty granules. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets. Referring to the expected low volatility of the substance, the fact that the substance is imported into the EU in a formulated form as liquid formulation, the exposure via inhalation is considered to be unlikely. The chemical showed low toxicity potential in the available acute oral toxicity studies (LD50>2000 mg/kg bw) with no mortality or systemic toxicity, hence it does not need to be classified STOT SE. Taking the above arguments into account, low toxicity potential is expected on acute exposure of Disperse Blue 165-1 via inhalation route and hence testing by the inhalation route was considered scientifically not necessary.   Acute Dermal Toxicity Study: Currently no study to assess the acute dermal toxicity of Disperse Blue 165:1 is available. However, it possesses molecular weight of 425.4 g/mol, hence considered to have limited dermal absorption. Also, it was found to have very low solubility in water (0.20 mg/L), hence dermal uptake is likely to be low as the substance is considered as not sufficiently soluble in water to partition from theStratum corneuminto the epidermis, again indicating limited dermal absorption. Synthesis and spray drying of this chemical is performed in a closed process; without isolation of reaction products. Isolated products consist of either liquid formulations or dust free granules (non-dusty solid). In addition, the use of this substance will not result in aerosols, particles or droplets, so exposure to humans via the dermal route will be unlikely to occur. The chemical showed low toxicity potential in the available acute oral toxicity studies (LD50>2000 mg/kg bw) with no mortality or systemic toxicity, hence it does not need to be classified STOT SE. Similarly, absence of local or systemic toxicity in skin irritation and sensitisation studies further supports the conclusion that low toxicity is expected for the chemical via the dermal route. Taking above arguments into account, low toxicity potential is expected on acute exposure of Disperse Blue 165 -1 via dermal route and hence acute toxicity testing by the dermal route was considered scientifically not necessary. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): High quality GLP study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a06ec700-e68c-4ad6-b0af-e78a4f6fd251/documents/IUC5-21ce34e2-1193-4150-b3bd-c919bf955c8c_d7dd1913-a763-4cfe-a317-083d938261c2.html,,,,,, "N-[2-[(2-cyano-4,6-dinitrophenyl)azo]-5-(diethylamino)phenyl]acetamide",24170-60-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a06ec700-e68c-4ad6-b0af-e78a4f6fd251/documents/IUC5-21ce34e2-1193-4150-b3bd-c919bf955c8c_d7dd1913-a763-4cfe-a317-083d938261c2.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, N-[2-[2-(2-methoxyethoxy)ethoxy]ethyl]-2-methyl-propan-2-amine,926622-96-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af2e909c-ebb9-4a64-815b-c1f6cfe46d72/documents/7434f296-9072-4d94-af5a-ee185903e1a2_ac3f5a75-865d-432a-847d-4a9d48ecdc87.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat N-[2-[2-(2-methoxyethoxy)ethoxy]ethyl]-2-methyl-propan-2-amine,926622-96-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af2e909c-ebb9-4a64-815b-c1f6cfe46d72/documents/2913037e-85b0-4db2-9dbd-0cf90afce73f_ac3f5a75-865d-432a-847d-4a9d48ecdc87.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, N-[2-[Bis(carboxymethyl)amino]ethyl]-N-(1-oxononyl)glycine,199387-97-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP guideline study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d06dfe73-c9a8-496c-aade-8a940850f06b/documents/8d69034f-6bac-4307-98ff-44b07f0b92f9_88f7aa2d-5742-4216-864a-65dc1c983f83.html,,,,,, N-[2-[Bis(carboxymethyl)amino]ethyl]-N-(1-oxononyl)glycine,199387-97-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d06dfe73-c9a8-496c-aade-8a940850f06b/documents/8d69034f-6bac-4307-98ff-44b07f0b92f9_88f7aa2d-5742-4216-864a-65dc1c983f83.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "N-[3-({[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino}methyl)-3,5,5-trimethylcyclohexyl]-2,2-dimethyl-3-(morpholin-4-yl)propan-1-imine",1217271-02-7," Under the conditions of the repeated dose oral toxicity study, the test item administered at 1000, 300 or 100 mg/kg bw/day did not cause signs of systemic toxicity. The NOAEL was thus determined to be 1000 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0df16294-ce48-4a65-bade-0a34f1f2afbc/documents/a586e92d-6ee0-420f-9fde-d89c83244c82_b80462de-09d1-4bf2-bb8e-729b4bbea592.html,,,,,, "N-[3-({[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino}methyl)-3,5,5-trimethylcyclohexyl]-2,2-dimethyl-3-(morpholin-4-yl)propan-1-imine",1217271-02-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0df16294-ce48-4a65-bade-0a34f1f2afbc/documents/a586e92d-6ee0-420f-9fde-d89c83244c82_b80462de-09d1-4bf2-bb8e-729b4bbea592.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N-[3-({[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino}methyl)-3,5,5-trimethylcyclohexyl]-2,2-dimethyl-3-(morpholin-4-yl)propan-1-imine",1217271-02-7,Sika Hardener MI was tested for acute oral toxicity in study with rats according to OECD Guideline 423 (Acute toxic class method). The study revealed an acute oral toxicity greater than 2000 mg/kg bw in rats. In an acute dermal toxicity study conducted according to OECD Guideline 402 the dermal toxicity was found to be greater than 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0df16294-ce48-4a65-bade-0a34f1f2afbc/documents/f62085ff-7472-49b2-b572-ee727a4c5c5f_b80462de-09d1-4bf2-bb8e-729b4bbea592.html,,,,,, "N-[3-({[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino}methyl)-3,5,5-trimethylcyclohexyl]-2,2-dimethyl-3-(morpholin-4-yl)propan-1-imine",1217271-02-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0df16294-ce48-4a65-bade-0a34f1f2afbc/documents/f62085ff-7472-49b2-b572-ee727a4c5c5f_b80462de-09d1-4bf2-bb8e-729b4bbea592.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N-[3-({[2,2-dimethyl-3-(morpholin-4-yl)propylidene]amino}methyl)-3,5,5-trimethylcyclohexyl]-2,2-dimethyl-3-(morpholin-4-yl)propan-1-imine",1217271-02-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0df16294-ce48-4a65-bade-0a34f1f2afbc/documents/f62085ff-7472-49b2-b572-ee727a4c5c5f_b80462de-09d1-4bf2-bb8e-729b4bbea592.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, N-[3-(diethylamino)phenyl]acetamide,6375-46-8," Acute toxicity: oral The acute toxicity study was predicted using OECD QSAR toolbox version 3.3 (2017); to evaluate the toxic effects of administration of N-[3-(diethylamino)ph enyl]acetamide (CAS No. 6375-46-8) in mouse by the oral route. 50% mortality was observed. The acute oral median lethal dose (LD50) of N-[3-(diethylamino) phenyl]acetamide in mouse was estimated to be 3306.05 mg/kg b.wt. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, it infers that N-[3-(diethylamino)phenyl]acetamide (CAS No. 6375-46-8) does not exhibit acute toxicity via the oral route. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/507c3a86-0cb6-481e-a8ea-cd2e3e9cc530/documents/708a5fee-80bc-4feb-ba6a-75ea2b5c27f5_f80771f6-d43d-4c7a-80bf-cc976fd692a9.html,,,,,, N-[3-(diethylamino)phenyl]acetamide,6375-46-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/507c3a86-0cb6-481e-a8ea-cd2e3e9cc530/documents/708a5fee-80bc-4feb-ba6a-75ea2b5c27f5_f80771f6-d43d-4c7a-80bf-cc976fd692a9.html,,oral,LD50,"3,306.05 mg/kg bw",no adverse effect observed, N-[3-(dimethoxymethylsilyl)-2-methylpropyl]ethylenediamine,23410-40-4," Oral (OECD 408), rat: NOAEL = 300 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f772be4-0c8b-4783-b53f-2d8cbcb23c9e/documents/1446f3db-cd68-486b-96b2-0cf409ea7acc_d83a7bfc-9b0b-4c6c-9547-838e29cb59dd.html,,,,,, N-[3-(dimethoxymethylsilyl)-2-methylpropyl]ethylenediamine,23410-40-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f772be4-0c8b-4783-b53f-2d8cbcb23c9e/documents/1446f3db-cd68-486b-96b2-0cf409ea7acc_d83a7bfc-9b0b-4c6c-9547-838e29cb59dd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat N-[3-(dimethoxymethylsilyl)-2-methylpropyl]ethylenediamine,23410-40-4,"Oral (similar to OECD 401): LD50 (female) = 436 mg/kg bw, LD50 (male) = 866 mg/kg bw, LD50 (male/female) = 653 mg/kg bwInhalation (OECD 403): LC50 > 600 mg/m³ (maximum achievable concentration)Dermal (similar to OECD 402): LD50 > 2000 mg/kg bw Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, of Regulation (EC) No 1907/2006. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f772be4-0c8b-4783-b53f-2d8cbcb23c9e/documents/230f5567-d9ce-4c42-89a8-49798a769b35_d83a7bfc-9b0b-4c6c-9547-838e29cb59dd.html,,,,,, N-[3-(dimethoxymethylsilyl)-2-methylpropyl]ethylenediamine,23410-40-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f772be4-0c8b-4783-b53f-2d8cbcb23c9e/documents/230f5567-d9ce-4c42-89a8-49798a769b35_d83a7bfc-9b0b-4c6c-9547-838e29cb59dd.html,,oral,LD50,436 mg/kg bw,adverse effect observed, N-[3-(dimethoxymethylsilyl)-2-methylpropyl]ethylenediamine,23410-40-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f772be4-0c8b-4783-b53f-2d8cbcb23c9e/documents/230f5567-d9ce-4c42-89a8-49798a769b35_d83a7bfc-9b0b-4c6c-9547-838e29cb59dd.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, N-[3-(dimethoxymethylsilyl)-2-methylpropyl]ethylenediamine,23410-40-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f772be4-0c8b-4783-b53f-2d8cbcb23c9e/documents/230f5567-d9ce-4c42-89a8-49798a769b35_d83a7bfc-9b0b-4c6c-9547-838e29cb59dd.html,,inhalation,LC50,> 600 mg/m3,no adverse effect observed, N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine,3069-29-2," In a 90-day repeated dose oral toxicity study with N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine (CAS No. 3069-29-2, EC No. 221-336-6), conducted according to OECD Test Guideline 408 and in compliance with GLP, the NOAEL for systemic effects was concluded to be 300 mg/kg bw/day based on renal lesions observed at the highest dose tested, 500 mg/kg bw/day (BSL Bioservice, 2021). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/960e3159-11e1-4106-b675-2ff88549de9d/documents/e95a4149-a803-44a3-a723-bf61637fd57b_709b2cde-deca-46dd-8f29-2d853b330bb8.html,,,,,, N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine,3069-29-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/960e3159-11e1-4106-b675-2ff88549de9d/documents/e95a4149-a803-44a3-a723-bf61637fd57b_709b2cde-deca-46dd-8f29-2d853b330bb8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine,3069-29-2,"The key study for acute oral toxicity, conducted according to OECD Test Guideline 423 and in compliance with GLP,  reported an LD50 value of 200 - 2000 mg/kg bw for the registered substance, N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine (CAS No. 3069-29-2, EC No. 221-336-6, Huntingdon Life Sciences, 1999). The result of this study is the most precautionary of the three available acute oral toxicity tests. Although the lower dose of 200 mg/kg bw, selected in the study, is below the recommended lower dose of 300 mg/kg bw by the current guideline, it was in line with the recommendations of the older version of OECD Test Guideline 423. Even though the lower dose of 200 mg/kg bw is below the threshold for Category 4 classification for acute oral toxicity, the supporting studies for the registered substance and other available information about the category suggest that classification Category 4 is appropriate.   The key study for acute inhalation toxicity, conducted according to OECD Test Guideline 403 and in compliance with GLP, reported an LC50 value of >5.2 mg/l air for the registered substance, N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine, in response to the exposure to an aerosol in rat (Hoechst, 1992).   The key study for acute dermal toxicity for the registered substance, N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine, conducted according to a protocol similar to OECD Test Guideline 402 and prior to GLP, reported an LD50 value of 16 ml/kg (equivalent to 15520 mg/kg bw) for males and >16 ml/kg for female rabbits (BRRC, 1982). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/960e3159-11e1-4106-b675-2ff88549de9d/documents/d40a45c4-838f-43fc-85b6-78812395d8ea_709b2cde-deca-46dd-8f29-2d853b330bb8.html,,,,,, N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine,3069-29-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/960e3159-11e1-4106-b675-2ff88549de9d/documents/d40a45c4-838f-43fc-85b6-78812395d8ea_709b2cde-deca-46dd-8f29-2d853b330bb8.html,,oral,LD50,200 mg/kg bw,adverse effect observed, N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine,3069-29-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/960e3159-11e1-4106-b675-2ff88549de9d/documents/d40a45c4-838f-43fc-85b6-78812395d8ea_709b2cde-deca-46dd-8f29-2d853b330bb8.html,,dermal,LD50,"15,520 mg/kg bw",no adverse effect observed, N-[3-(dimethoxymethylsilyl)propyl]ethylenediamine,3069-29-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/960e3159-11e1-4106-b675-2ff88549de9d/documents/d40a45c4-838f-43fc-85b6-78812395d8ea_709b2cde-deca-46dd-8f29-2d853b330bb8.html,,inhalation,LC50,"5,200 mg/m3",no adverse effect observed, "N-[3-(dimethylamino)propyl]-3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonamide N-oxide",80475-32-7," OECD 422: Based on the histopathological findings in the liver of the males, together with the clinical chemistry observations, the NOAEL for parental toxicity was conservatively placed at 1 mg/kg body weight per day. Microscopic analysis of the control and the mid-dose groups, revealed treatment-related pathology in the liver, characterized by minimal to moderate centrilobular hepatocellular microvacuolation in the males of the mid-dose group (20 mg/kg bw). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/def804a6-3218-454a-96f0-cfe06e530f8b/documents/5888d52b-0dbf-49b4-9486-1be7ec08d3cc_32b3d3af-94f5-4f55-9054-63de80da219b.html,,,,,, "N-[3-(dimethylamino)propyl]-3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonamide N-oxide",80475-32-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/def804a6-3218-454a-96f0-cfe06e530f8b/documents/5888d52b-0dbf-49b4-9486-1be7ec08d3cc_32b3d3af-94f5-4f55-9054-63de80da219b.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,20 mg/kg bw/day,,rat "N-[3-(dimethylamino)propyl]-3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonamide N-oxide",80475-32-7, Oral: rat LD50: >2000 mg/kg. OECD 420; Reliability = 1 Dermal: Data Waived (the substance does not meet the criteria for classification as acute toxicity by oral route) Inhalation: Data Waived (exposure of humans via inhalation route is not likely) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/def804a6-3218-454a-96f0-cfe06e530f8b/documents/9d15dbe0-11d8-49fb-97bd-e5c8f04f2bde_32b3d3af-94f5-4f55-9054-63de80da219b.html,,,,,, "N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine",3855-32-1," In a repeat dose study was according to OECD Guidelines (No. 422/GLP), oral administration of the test substance to Wistar rats by gavage (50, 100 and 200 mg/kg/day) for 42 day resulted in treatment-related clinical signs, changes in the body weights, feed consumption and microscopic effects in male and female animals dosed at 100 and 200 mg/kg/day. No toxicologically significant effects were detected in both sex treated with 50 mg/kg/day. The vacuolation detected in the various organs of high dose and intermediate dose group were considered to be treatment related and no recovery of microscopic changes were noted in the satellite group. Hence, the 'No Observed Effect Level' (NOEL) for systemic toxicity is considered to be 50 mg/kg/day.   Treatment-related reproduction / developmental toxicity effect of influencing the  sex ratio (decrease in the % male offspring) were observed in the high dose group (200 mg/kg/day). Test item related microscopic changes were observed in the testes and epididymides of male and ovaries of female animals in the high dose group (200 mg/kg/day). No treatment-related effects were observed on reproduction/ development indices of animals in the 50 and 100  mg/kg/day dose groups. Mating index, fertility index, gestation length, pre-implantation loss, post-implantation loss, sex ratio and offspring growth and development were unaffected. Some of the observed effects appear consistent with the animals being administered a corrosive/irritating substance. However, a No Observed Effect Level (NOEL) for systemic toxicity was derived at 50 mg/kg/day, whilst the No Observed Effect Level (NOEL) for reproductive effects was determined as 100 mg/kg/day. A 90 -day repeat-dose oral study according to OECD TG 408 was performed. The rats were treated with 10,30 or 100/65 mg PU‑2018-788 (Polycat 77)/kg b.w./day by daily oral administration. Due to a reduction of body weight of the high dosed animals greater than recommended, the initial dose of 100 mg/kg b.w. was reduced to 65 mg/kg b.w. as of test day 15. The control animals received the vehicle (distilled water). None of the animals died or had to be sacrificed prematurely. In conclusion, adverse test item-related effects were noted a t30 mg PU‑2018-788 (Polycat 77)/kg b.w./day (in form of histopathological changes) and at 100/65 mg PU‑2018-788 (Polycat 77)/kg b.w./day (in form of a reduced body weight, a decreased food consumption, an increased drinking water consumption, and at histopathological examination) compared to the control group.Based on the above results, the no-observed-effect level (NOEL) was10 mg PU‑2018-788 (Polycat 77)/kg b.w./day by oral administration for 90 days. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ef10d0a-e829-481b-8e34-049c79a55702/documents/1b47470e-f277-4ebe-adb6-6c449142e02b_ad66e395-cbd4-42aa-97d1-38c9c409d25e.html,,,,,, "N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine",3855-32-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ef10d0a-e829-481b-8e34-049c79a55702/documents/1b47470e-f277-4ebe-adb6-6c449142e02b_ad66e395-cbd4-42aa-97d1-38c9c409d25e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine",3855-32-1,Oral LD50 = 1598 mg/kgInhalation LC50 = 1480 mg/m³Dermal LD50 = 569 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ef10d0a-e829-481b-8e34-049c79a55702/documents/8faaf424-8b5a-4f41-b0d1-1c34a94df516_ad66e395-cbd4-42aa-97d1-38c9c409d25e.html,,,,,, "N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine",3855-32-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ef10d0a-e829-481b-8e34-049c79a55702/documents/8faaf424-8b5a-4f41-b0d1-1c34a94df516_ad66e395-cbd4-42aa-97d1-38c9c409d25e.html,,oral,LD50,"1,598 mg/kg bw",adverse effect observed, "N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine",3855-32-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ef10d0a-e829-481b-8e34-049c79a55702/documents/8faaf424-8b5a-4f41-b0d1-1c34a94df516_ad66e395-cbd4-42aa-97d1-38c9c409d25e.html,,dermal,LD50,569 mg/kg bw,adverse effect observed, "N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine",3855-32-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ef10d0a-e829-481b-8e34-049c79a55702/documents/8faaf424-8b5a-4f41-b0d1-1c34a94df516_ad66e395-cbd4-42aa-97d1-38c9c409d25e.html,,inhalation,LC50,"1,480 ",adverse effect observed, "N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine",6711-48-4,"Data generated with the related substances DMAPA and DEAPA are used for endpoint coverage. In a short-term repeated dose toxicity study, 3 -Dimethylaminopropylamin (DMAPA) caused clinical symptoms and mortality in male and female Wistar rats when administered during 28 days at the dose level of 250 mg/kg body weight, which was therefore the LOAEL for this substance. Since no adverse effects were seen at 50 mg/kg bw, this dose level was set as NOAEL.  In a subchronic repeated dose toxicity study via oral administration, the NOAEL for DEAPA was established at 750 mg/kg bw/day in male and 250 mg/kg bw/day in female rats.  In a maximum tolerated dose study in rabbits, there were no adverse effects up to 300 mg/kg bw/day. The MTD was considered to be within the [300;1000] mg/kg bw/day. The same is assumed to be correct for the test substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP guideline study ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b776aa3-9c6d-4fa0-ba71-b0ed4e40bfb7/documents/IUC5-2b0983ff-97fa-45f0-bb9a-38bd1238e574_d26a208a-235d-4413-9f5e-619013270d4a.html,,,,,, "N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine",6711-48-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b776aa3-9c6d-4fa0-ba71-b0ed4e40bfb7/documents/IUC5-2b0983ff-97fa-45f0-bb9a-38bd1238e574_d26a208a-235d-4413-9f5e-619013270d4a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine",6711-48-4,"Acute oral toxicity: The oral LD50 in male/female Sprague-Dawley rats was estimated to be 1250 mg/kg bw based on the results of an key study conducted according to OECD Guideline 401 and EPA OTS 798.1175 (Mallory, 2000) and a supporting study according to OECD Guideline 401 (American Cyanamid Company, 1964). Acute inhalation toxicity: Two K2 studies were performed according to a method similar to OECD Guideline 403. The studies are used in a weight of evidence approach. None of the animals died during the study (Jipina, 1978 and American Cyanamid Company, 1964). Acute dermal toxicity: In a study conducted similar to OECD Guideline 402, the acute dermal LD50 was determined to be 370 mg/kg bw in male/female New Zealand White rabbits (American Cyanamid Company, 1964) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b776aa3-9c6d-4fa0-ba71-b0ed4e40bfb7/documents/IUC5-5470cd9a-6483-4083-ab7a-2b8bcc8d24f4_d26a208a-235d-4413-9f5e-619013270d4a.html,,,,,, "N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine",6711-48-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b776aa3-9c6d-4fa0-ba71-b0ed4e40bfb7/documents/IUC5-5470cd9a-6483-4083-ab7a-2b8bcc8d24f4_d26a208a-235d-4413-9f5e-619013270d4a.html,,oral,LD50,"1,250 mg/kg bw",adverse effect observed, "N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine",6711-48-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b776aa3-9c6d-4fa0-ba71-b0ed4e40bfb7/documents/IUC5-5470cd9a-6483-4083-ab7a-2b8bcc8d24f4_d26a208a-235d-4413-9f5e-619013270d4a.html,,dermal,LD50,370 mg/kg bw,adverse effect observed, "N'-[3-(dimethylamino)propyl]-N,N-dimethylpropane-1,3-diamine",6711-48-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b776aa3-9c6d-4fa0-ba71-b0ed4e40bfb7/documents/IUC5-5470cd9a-6483-4083-ab7a-2b8bcc8d24f4_d26a208a-235d-4413-9f5e-619013270d4a.html,,inhalation,LC50,> 2.63 mg/L,no adverse effect observed, N-[3-(dimethylamino)propyl]stearamide monoacetate,13282-70-7," One valid repeated dose toxicity studies are available for the test item NDPSa (Cas n.: 13282-70-7,other identifier: H-31339).    Repeated Dose Oral 28 days, EU B.7, K1; NOAEL= 5 mg/kg body weight/day, LOAEL=25 mg/kg; Hoban D.B.A. (2015) Supporting Study: Repeated Dose Oral 14 days, EU B.7, S1; (NOAEL) 100 mg/kg/day in male rats and 250 mg/kg/day in female rats; Hoban D.B.A. (2015)   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6311dce1-8737-4458-8caf-82dcdb51bbb1/documents/4984f8cb-b12c-42b2-8598-e3623b553a6a_dfe022d7-a46d-4f75-8f97-59d717ce7d03.html,,,,,, N-[3-(dimethylamino)propyl]stearamide monoacetate,13282-70-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6311dce1-8737-4458-8caf-82dcdb51bbb1/documents/4984f8cb-b12c-42b2-8598-e3623b553a6a_dfe022d7-a46d-4f75-8f97-59d717ce7d03.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat N-[3-(dimethylamino)propyl]stearamide monoacetate,13282-70-7," Three studies are available for this endpoint. The test item NDPSa (H-31339, Cas n.:13282-70-7). Acute Tox. Oral: K1, Oral, OECD TG 425, 14-days up-and-down procedure on Rats; LD50= 1403 mg/kg, M. N. Fallers, B.A. (2015) Acute Tox. Inhalation: K1, OECD TG 403, Rat 4-hr inhalation aerosol, LC50 > 4 mg/L (maximum practically-attainable atmospheric concentration), LC50 > 0.66 mg/L (solids aerosol concentration), Sheung P.Ng. (2015) Acute Tox. Dermal: K1, OECD B.3, Rat 24 hr, LD50 >5000 mg/kg, M.N. Fallers, B.A. (2015)   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6311dce1-8737-4458-8caf-82dcdb51bbb1/documents/6319342e-cc91-4bfd-8227-67839c9ff88a_dfe022d7-a46d-4f75-8f97-59d717ce7d03.html,,,,,, N-[3-(dimethylamino)propyl]stearamide monoacetate,13282-70-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6311dce1-8737-4458-8caf-82dcdb51bbb1/documents/6319342e-cc91-4bfd-8227-67839c9ff88a_dfe022d7-a46d-4f75-8f97-59d717ce7d03.html,,oral,LD50,"1,403 mg/kg bw",adverse effect observed, N-[3-(dimethylamino)propyl]stearamide monoacetate,13282-70-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6311dce1-8737-4458-8caf-82dcdb51bbb1/documents/6319342e-cc91-4bfd-8227-67839c9ff88a_dfe022d7-a46d-4f75-8f97-59d717ce7d03.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, N-[3-(dimethylamino)propyl]stearamide monoacetate,13282-70-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6311dce1-8737-4458-8caf-82dcdb51bbb1/documents/6319342e-cc91-4bfd-8227-67839c9ff88a_dfe022d7-a46d-4f75-8f97-59d717ce7d03.html,,inhalation,LC50,0.66 mg/L,no adverse effect observed, N-[3-(methoxydimethylsilyl)propyl]ethylenediamine,3069-33-8,"Oral (OECD 423), rat: LD50 = 1000 mg/kg bw (cut-off value) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/add2318d-d433-4dc4-b518-f7b9b5306cbf/documents/IUC5-76205ae1-75c4-4dfb-8593-0600e5748f79_a93661d4-49e6-41bf-8a37-1f2d5177a26a.html,,,,,, N-[3-(methoxydimethylsilyl)propyl]ethylenediamine,3069-33-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/add2318d-d433-4dc4-b518-f7b9b5306cbf/documents/IUC5-76205ae1-75c4-4dfb-8593-0600e5748f79_a93661d4-49e6-41bf-8a37-1f2d5177a26a.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, N-[3-(triethoxysilyl)propyl]ethylenediamine,5089-72-5,"RDT (oral): OECD 422 (including FOB), rat: NOAEL ≥500 mg/kg bw/day (RA from CAS 1760-24-3) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc7951a4-efa3-47e5-af46-4fd0ff56e39f/documents/5528cbde-21fb-4be8-8b7c-2e6c14203409_835a6593-083a-49a0-894f-4d935b6d33e4.html,,,,,, N-[3-(triethoxysilyl)propyl]ethylenediamine,5089-72-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc7951a4-efa3-47e5-af46-4fd0ff56e39f/documents/5528cbde-21fb-4be8-8b7c-2e6c14203409_835a6593-083a-49a0-894f-4d935b6d33e4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat N-[3-(triethoxysilyl)propyl]ethylenediamine,5089-72-5,"Oral (OECD 401), rat: LD50 >2000 mg/kg bwInhalation (OECD 403), rat: LC50 = 1.1 mg /l (male)/1.18 mg/l (female) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc7951a4-efa3-47e5-af46-4fd0ff56e39f/documents/e0abd27c-59e1-4a93-b5f6-965978b2bfcc_835a6593-083a-49a0-894f-4d935b6d33e4.html,,,,,, N-[3-(triethoxysilyl)propyl]ethylenediamine,5089-72-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc7951a4-efa3-47e5-af46-4fd0ff56e39f/documents/e0abd27c-59e1-4a93-b5f6-965978b2bfcc_835a6593-083a-49a0-894f-4d935b6d33e4.html,,inhalation,LC50,"1,100 mg/m3",adverse effect observed, N-[3-(Triethoxysilyl)propyl]formamide,76524-94-2,Oral rat fixed dose: LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ddbb356-60c4-4ee1-a562-a52ab70f7e59/documents/IUC5-df565bed-08ea-46a9-bdb2-a706ed7fb2ac_f0b61b5e-8d64-4804-bfe5-03a6bbc9b551.html,,,,,, N-[3-(Triethoxysilyl)propyl]formamide,76524-94-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ddbb356-60c4-4ee1-a562-a52ab70f7e59/documents/IUC5-df565bed-08ea-46a9-bdb2-a706ed7fb2ac_f0b61b5e-8d64-4804-bfe5-03a6bbc9b551.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, N-[3-(trimethoxysilyl)propyl]aniline,3068-76-6,"Acute toxicity:Oral (OECD 401), rat: LD50 = 704 mg/kg bwDermal (OECD 402), rat: LD50 > 2000 mg/kg bwInhalation: no study available ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1014c58d-01eb-4411-b29c-7bd5b8785f7e/documents/9f2cda36-c017-40a7-96d3-3ca297343f75_162d3ac8-c3ed-4741-86af-5dc83b2fceeb.html,,,,,, N-[3-(trimethoxysilyl)propyl]aniline,3068-76-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1014c58d-01eb-4411-b29c-7bd5b8785f7e/documents/9f2cda36-c017-40a7-96d3-3ca297343f75_162d3ac8-c3ed-4741-86af-5dc83b2fceeb.html,,oral,LD50,704 mg/kg bw,no adverse effect observed, N-[3-(trimethoxysilyl)propyl]aniline,3068-76-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1014c58d-01eb-4411-b29c-7bd5b8785f7e/documents/9f2cda36-c017-40a7-96d3-3ca297343f75_162d3ac8-c3ed-4741-86af-5dc83b2fceeb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, N-[3-(trimethoxysilyl)propyl]butylamine,31024-56-3,"Oral (OECD 408), rat: NOAELsystemic: 500 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb84b67d-16ec-417d-b7d6-885d8777af18/documents/7ad107b2-1d46-41cf-808f-e43c835af16d_6cf0fa9a-309c-46fc-a334-97d811c9887d.html,,,,,, N-[3-(trimethoxysilyl)propyl]butylamine,31024-56-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb84b67d-16ec-417d-b7d6-885d8777af18/documents/7ad107b2-1d46-41cf-808f-e43c835af16d_6cf0fa9a-309c-46fc-a334-97d811c9887d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat N-[3-(trimethoxysilyl)propyl]butylamine,31024-56-3,"Oral (similar to OECD TG 401), rat: LD50 = 12 825 mg/kg bw (male)Dermal (similar to OECD TG 402), rabbit: LD50 = 15 200 mg/kg bw (male)Inhalation: no reliable data available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb84b67d-16ec-417d-b7d6-885d8777af18/documents/67e35b4e-ac17-4216-855d-25b2d545e7a6_6cf0fa9a-309c-46fc-a334-97d811c9887d.html,,,,,, N-[3-(trimethoxysilyl)propyl]butylamine,31024-56-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb84b67d-16ec-417d-b7d6-885d8777af18/documents/67e35b4e-ac17-4216-855d-25b2d545e7a6_6cf0fa9a-309c-46fc-a334-97d811c9887d.html,,oral,LD50,"12,825 mg/kg bw",no adverse effect observed, N-[3-(trimethoxysilyl)propyl]butylamine,31024-56-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb84b67d-16ec-417d-b7d6-885d8777af18/documents/67e35b4e-ac17-4216-855d-25b2d545e7a6_6cf0fa9a-309c-46fc-a334-97d811c9887d.html,,dermal,LD50,"15,200 mg/kg bw",no adverse effect observed, N-[3-(trimethoxysilyl)propylcyclohexylamine],3068-78-8,"Oral, subacute (OECD 422, rat): NOAEL (systemic) = 250/175 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c0ff75f-f0ad-4b17-bf18-e39c46ab6f8a/documents/c2e86998-e01f-41be-a5c9-e3aa884dce7e_58bb1575-f78e-4ded-9e4a-c7b18635dd86.html,,,,,, N-[3-(trimethoxysilyl)propylcyclohexylamine],3068-78-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0c0ff75f-f0ad-4b17-bf18-e39c46ab6f8a/documents/c2e86998-e01f-41be-a5c9-e3aa884dce7e_58bb1575-f78e-4ded-9e4a-c7b18635dd86.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,175 mg/kg bw/day,,rat N-[3-(trimethoxysilyl)propylcyclohexylamine],3068-78-8,"Acute oral toxicity (OECD 401, rat): LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c0ff75f-f0ad-4b17-bf18-e39c46ab6f8a/documents/31c2f86f-27f2-4f56-8de9-1d5abf1c87e8_58bb1575-f78e-4ded-9e4a-c7b18635dd86.html,,,,,, N-[3-(trimethoxysilyl)propylcyclohexylamine],3068-78-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c0ff75f-f0ad-4b17-bf18-e39c46ab6f8a/documents/31c2f86f-27f2-4f56-8de9-1d5abf1c87e8_58bb1575-f78e-4ded-9e4a-c7b18635dd86.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, N-[4-(acetylamino)phenyl]-4-[[5-(aminocarbonyl)-2-chlorophenyl]azo]-3-hydroxynaphthalene-2-carboxamide,12236-64-5,"Repeated oral toxicity: Pigment Red 112 The toxicity of the test item, the close analogue PR 112, when given by oral administration (gavage) to groups of 5 rats per sex per dose for 28 consecutive days at dosages of 0, 100, 300 or 1000 mg/kg bw/day, for 7 days/week have been investigated. No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). Red staining of various body parts, red faeces and reddish contents of the gastro-intestinal tract noted among all groups treated with the test substance was considered to be related to staining properties of the test substance, and not to represent signs of systemic toxicity. No correlating histopathological abnormalities were noted. On the basis of these results, the high dose level of 1000 mg/kg/day was considered to be the No Observed Adverse Effect Level (NOAEL) for the test substance.   PR022 A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test was performed according to OECD TG 422. The test item, the close analogue Pigment Red 22, was administered to Sprague Dawley rats (12/sex/dose) by gavage at dose levels of 0, 100, 300 and 1000 mg/kg/day for a total of 37 days (males) and through mating, gestation and delivery until day 4 of lactation (females). No toxic effects were observed in this study except increased liver weights in males and females of the highest dose group. As the effects on liver weight were minimal (less than 10% weight changes) and not accompanied by any histopathological or biochemical changes these effects were judged not to be adverse. The no-observed-adverse-effect level (NOAEL) for repeated dose toxicity was 1000 mg/kg under the conditions of this study. There were no effects on reproduction or development. Repeated inhalation toxicity: PR112 The objective of the OECD TG 413 following study was to determine the toxic potential of the test item and close analogue, Pigment Red 112, when administered for 6 hours/day, 5 days per week, for 13 consecutive weeks by flow-past nose-only inhalation route to Sprague Dawley rats. This study provides information on toxic effects, target organs, the possibility of cumulative effects, the reversibility of effects (after 90 and 180 days recovery period), and an estimate of the No Observed Adverse Effects Concentration (NOAEC). Based on the observed results, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item was found to be 30 mg/m³ (0,03 mg/L) after 90 days of exposure (highest concentration tested). The nominal dose of 0.03 mg/L (6 hrs/day, 5 days/week) corresponded to an actual exposure concentration in males and females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6bbf4ab-181e-4fcb-92fe-a12a8ee5ebd7/documents/ddc2c0b7-67ed-4196-9382-e2e5a947e775_f56b62cc-ee4a-437b-9e39-1fdf6e09b9c5.html,,,,,, N-[4-(acetylamino)phenyl]-4-[[5-(aminocarbonyl)-2-chlorophenyl]azo]-3-hydroxynaphthalene-2-carboxamide,12236-64-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6bbf4ab-181e-4fcb-92fe-a12a8ee5ebd7/documents/ddc2c0b7-67ed-4196-9382-e2e5a947e775_f56b62cc-ee4a-437b-9e39-1fdf6e09b9c5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat N-[4-(acetylamino)phenyl]-4-[[5-(aminocarbonyl)-2-chlorophenyl]azo]-3-hydroxynaphthalene-2-carboxamide,12236-64-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6bbf4ab-181e-4fcb-92fe-a12a8ee5ebd7/documents/ddc2c0b7-67ed-4196-9382-e2e5a947e775_f56b62cc-ee4a-437b-9e39-1fdf6e09b9c5.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat N-[4-(acetylamino)phenyl]-4-[[5-(aminocarbonyl)-2-chlorophenyl]azo]-3-hydroxynaphthalene-2-carboxamide,12236-64-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6bbf4ab-181e-4fcb-92fe-a12a8ee5ebd7/documents/ddc2c0b7-67ed-4196-9382-e2e5a947e775_f56b62cc-ee4a-437b-9e39-1fdf6e09b9c5.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat N-[4-(acetylamino)phenyl]-4-[[5-(aminocarbonyl)-2-chlorophenyl]azo]-3-hydroxynaphthalene-2-carboxamide,12236-64-5,Oral Toxicity A close structural analogue (PR112) did not cause any mortality or significant clinical signs or necropsy findings after single oral gavage administration to male and female rats at 5000 mg/kg bw in a OECD guideline and GLP compliant study. The LD50 (male/female rat) was greater than 5000 mg/kg body weight. Dermal Toxicity A close structural analogue (PR112) did not cause any mortality or significant clinical signs or necropsy findings after single dermal application to male rats at 5000 mg/kg bw in a OECD guideline compliant study. The LD50 (male rat) was greater than 5000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6bbf4ab-181e-4fcb-92fe-a12a8ee5ebd7/documents/2bcf68c5-2f53-40a2-b80a-0fd9ecd070af_f56b62cc-ee4a-437b-9e39-1fdf6e09b9c5.html,,,,,, N-[4-(acetylamino)phenyl]-4-[[5-(aminocarbonyl)-2-chlorophenyl]azo]-3-hydroxynaphthalene-2-carboxamide,12236-64-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6bbf4ab-181e-4fcb-92fe-a12a8ee5ebd7/documents/2bcf68c5-2f53-40a2-b80a-0fd9ecd070af_f56b62cc-ee4a-437b-9e39-1fdf6e09b9c5.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, N-[4-(acetylamino)phenyl]-4-[[5-(aminocarbonyl)-2-chlorophenyl]azo]-3-hydroxynaphthalene-2-carboxamide,12236-64-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6bbf4ab-181e-4fcb-92fe-a12a8ee5ebd7/documents/2bcf68c5-2f53-40a2-b80a-0fd9ecd070af_f56b62cc-ee4a-437b-9e39-1fdf6e09b9c5.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "N-[4-(aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzamide",74441-05-7,"As there were no treatment-related adverse effects observed after subchronic repeated oral administration up to the highest dose (1000 mg/kg bw). The No Observed Adverse Effect Level (NOAEL) for systemic toxicity of the test item is considered to be 1000 mg/kg/day under the test conditions and doses employed.  Based on the results observed in a sub acute inhalation study in rats, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item was found to be 0.03 mg/L (30 mg/m³) when exposed for 6 hours/day, 5 days/week, for 04 weeks by flow-past nose-only inhalation route to Sprague Dawley rats.  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): reliable with restriction (read across) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): reliable with restriction (read across) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable with restriction ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e210e889-0907-4949-8d87-dc410d030ba3/documents/d80d8d34-6364-41ac-aaa6-ed7515363153_7e7e8f86-9778-4f1d-bf4d-13717f55738f.html,,,,,, "N-[4-(aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzamide",74441-05-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e210e889-0907-4949-8d87-dc410d030ba3/documents/d80d8d34-6364-41ac-aaa6-ed7515363153_7e7e8f86-9778-4f1d-bf4d-13717f55738f.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat "N-[4-(aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzamide",74441-05-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e210e889-0907-4949-8d87-dc410d030ba3/documents/d80d8d34-6364-41ac-aaa6-ed7515363153_7e7e8f86-9778-4f1d-bf4d-13717f55738f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N-[4-(aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzamide",74441-05-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e210e889-0907-4949-8d87-dc410d030ba3/documents/d80d8d34-6364-41ac-aaa6-ed7515363153_7e7e8f86-9778-4f1d-bf4d-13717f55738f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,30 mg/m3,no adverse effect observed,rat "N-[4-(aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzamide",74441-05-7,"No adverse effects were observed after an oral dose of 5000 mg/kg in rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): reliable with restriction: read across ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e210e889-0907-4949-8d87-dc410d030ba3/documents/29501b8a-5f22-42bc-9fa4-1d9380d9c953_7e7e8f86-9778-4f1d-bf4d-13717f55738f.html,,,,,, "N-[4-(aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzamide",74441-05-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e210e889-0907-4949-8d87-dc410d030ba3/documents/29501b8a-5f22-42bc-9fa4-1d9380d9c953_7e7e8f86-9778-4f1d-bf4d-13717f55738f.html,,oral,LD0,">=5,000 mg/kg bw",no adverse effect observed, "N-[4-(aminocarbonyl)phenyl]-4-[[1-[[(2,3-dihydro-2-oxo-1H-benzimidazol-5-yl)amino]carbonyl]-2-oxopropyl]azo]benzamide",74441-05-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e210e889-0907-4949-8d87-dc410d030ba3/documents/29501b8a-5f22-42bc-9fa4-1d9380d9c953_7e7e8f86-9778-4f1d-bf4d-13717f55738f.html,,inhalation,LC0,"1,274 mg/m3",no adverse effect observed, N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide,27375-52-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): QSAR model considered reliable by OECD ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41ea16ac-6b8b-4bdc-b08d-881253b52705/documents/IUC5-6e033e31-2640-48d3-8688-b8cb8f0da0e3_d1d35596-5f75-4546-b44f-4f58523bef2e.html,,,,,, N-[4-[(2-hydroxyethyl)sulphonyl]phenyl]acetamide,27375-52-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41ea16ac-6b8b-4bdc-b08d-881253b52705/documents/IUC5-6e033e31-2640-48d3-8688-b8cb8f0da0e3_d1d35596-5f75-4546-b44f-4f58523bef2e.html,,oral,LD50,"2,225.802 mg/kg bw",no adverse effect observed, "N-[4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]phenyl]acetamide",67905-17-3,"Repeated dose toxicity: Oral A NOAEL for systemic toxicity, reproductive toxicity, and developmental toxicity of 1000 mg/kg bw/day in Wistar rats was concluded from a study performed according to OECD 422 and GLP.   Repeated dose toxicity: Inhalation A short-term toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the given test chemical has very low vapor pressure 3.28E-013 Pa (2.46E-015 mm Hg), so the potential for the generation of inhalable vapors is very low. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated inhalation toxicity was considered for waiver.   Repeated dose toxicity: Dermal A short-term toxicity study does not need to be conducted because exposure of humans via dermal in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the acute dermal toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/52970cc8-2c5b-4dd5-9976-ec24cfc27781/documents/a922c968-baa8-4600-ac3c-ae14a89f7348_8bce9983-15c7-4cbe-81a6-cc0a47bf6359.html,,,,,, "N-[4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]phenyl]acetamide",67905-17-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/52970cc8-2c5b-4dd5-9976-ec24cfc27781/documents/a922c968-baa8-4600-ac3c-ae14a89f7348_8bce9983-15c7-4cbe-81a6-cc0a47bf6359.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N-[4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]phenyl]acetamide",67905-17-3,"Acute oral toxicity:    The acute oral toxicity dose (LD50) was considered based on experimental study conducted on rats for the test chemical. The LD50 value is >5000 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity.Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.    Acute Inhalation Toxicity:   The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 3.28E-013 Pa (2.46E-015 mm Hg). Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity:   The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52970cc8-2c5b-4dd5-9976-ec24cfc27781/documents/2ed98ca8-e57e-45c1-8a93-2debc333c3e1_8bce9983-15c7-4cbe-81a6-cc0a47bf6359.html,,,,,, "N-[4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]phenyl]acetamide",67905-17-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52970cc8-2c5b-4dd5-9976-ec24cfc27781/documents/2ed98ca8-e57e-45c1-8a93-2debc333c3e1_8bce9983-15c7-4cbe-81a6-cc0a47bf6359.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "N-[4-[(9,10-dihydro-4-hydroxy-9,10-dioxo-1-anthryl)amino]phenyl]acetamide",67905-17-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/52970cc8-2c5b-4dd5-9976-ec24cfc27781/documents/2ed98ca8-e57e-45c1-8a93-2debc333c3e1_8bce9983-15c7-4cbe-81a6-cc0a47bf6359.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N-[4-[[(2-amino-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-L-glutamic acid",135-16-0," - study conducted according to OECD guideline 423, acute toxic class method, 6 female Wistar rats were exposed to a single dose of 2000 mg/kg bw Tetrahydrofolic acid in two steps and observed for 14 days, LD50 cut-off = 5000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7914a82-63be-4643-8f5f-61d3ab780cb5/documents/cbe22ed4-e1c2-4a21-8657-2d582fd95527_8f01596c-0c3e-41e1-b019-fd001190dc6d.html,,,,,, "N-[4-[[(2-amino-1,4,5,6,7,8-hexahydro-4-oxo-6-pteridinyl)methyl]amino]benzoyl]-L-glutamic acid",135-16-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7914a82-63be-4643-8f5f-61d3ab780cb5/documents/cbe22ed4-e1c2-4a21-8657-2d582fd95527_8f01596c-0c3e-41e1-b019-fd001190dc6d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N-{[1,1'-Biphenyl]-2-yl}-N-(9,9-dimethyl-9H-fluoren-2-yl)-7'-phenyl-9,9'-spirobi[fluoren]-7-amine",2423014-10-0, The test material was investigated for acute oral toxicity using in vivo methods. The GLP compliant study was fully compliant with OECD TG 423. The follwing results have been obtained: Acute toxicity: oral: OECD 423: LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbc6f8da-edb3-465c-9e2d-890575017066/documents/8cddf1ae-655a-4c48-8453-8fd95ead8c2f_b403e39a-16ef-41a0-bb8c-e5a1133be8af.html,,,,,, "N-{[1,1'-Biphenyl]-2-yl}-N-(9,9-dimethyl-9H-fluoren-2-yl)-7'-phenyl-9,9'-spirobi[fluoren]-7-amine",2423014-10-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cbc6f8da-edb3-465c-9e2d-890575017066/documents/8cddf1ae-655a-4c48-8453-8fd95ead8c2f_b403e39a-16ef-41a0-bb8c-e5a1133be8af.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, N-{3-[Dimethoxy(methyl)silyl]propyl}butan-1-amine,120939-52-8,"Oral (OECD 423), rat: LD50 cut-off = 2500 mg/kg bw Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b935851a-ec5c-46f7-ab77-a820b0334d62/documents/9d7d646a-91cb-4803-82a0-c6994c974fab_2aa3e7be-4745-4f85-8197-ce56886a80d6.html,,,,,, N-{3-[Dimethoxy(methyl)silyl]propyl}butan-1-amine,120939-52-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b935851a-ec5c-46f7-ab77-a820b0334d62/documents/9d7d646a-91cb-4803-82a0-c6994c974fab_2aa3e7be-4745-4f85-8197-ce56886a80d6.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, "N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine",793-24-8,"Several oral repeated dose toxicity studies were conducted to evaluate the toxicity of the test substance 6PPD. Overall, oral administration of 6PPD to male and female rats revealed adverse effects on the liver and changes in hematology. Based on the findings from the repeated dose toxicity studies covering sub-acute to chronic exposure a NOAEL of 20 mg/kg bw/day is taken as a starting point for DNEL calculation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6db9d2c-70c6-4e1d-af1b-145de0d0ea35/documents/IUC5-cca6f0cc-e920-4df4-a19b-1eae59b35340_7f5e5cd3-1413-49d3-ad6f-eea738d5336f.html,,,,,, "N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine",793-24-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6db9d2c-70c6-4e1d-af1b-145de0d0ea35/documents/IUC5-cca6f0cc-e920-4df4-a19b-1eae59b35340_7f5e5cd3-1413-49d3-ad6f-eea738d5336f.html,Chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,, "N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine",793-24-8,"The oral acute toxicity is moderate indicated by oral LD50 values in rats of 1005 mg/kg bw for males and 893 mg/kg bw for females (Hatano Research Institute 1999). The dermal acute toxicity is low indicated by a dermal LD50 in rabbits higher than 3000 mg/kg bw (Monsanto Co. 1962, 1973, Randall and Bannister, 1990). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6db9d2c-70c6-4e1d-af1b-145de0d0ea35/documents/IUC5-1c300a33-06af-403e-b57f-79f5e0709d31_7f5e5cd3-1413-49d3-ad6f-eea738d5336f.html,,,,,, "N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine",793-24-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6db9d2c-70c6-4e1d-af1b-145de0d0ea35/documents/IUC5-1c300a33-06af-403e-b57f-79f5e0709d31_7f5e5cd3-1413-49d3-ad6f-eea738d5336f.html,,oral,LD50,893 mg/kg bw,adverse effect observed, "N-1,3-dimethylbutyl-N'-phenyl-p-phenylenediamine",793-24-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6db9d2c-70c6-4e1d-af1b-145de0d0ea35/documents/IUC5-1c300a33-06af-403e-b57f-79f5e0709d31_7f5e5cd3-1413-49d3-ad6f-eea738d5336f.html,,dermal,LD50,"7,940 mg/kg bw",no adverse effect observed, "N1,N2-dimethyl-N1-{2-[methyl(propan-2-yl)amino]ethyl}-N2-(propan-2-yl)ethane-1,2-diamine",1042950-30-0,"The repeated dose toxicity of N-isopropyl-N'-{2-[isopropyl(methyl)amino]ethyl}-N,N'-dimethylethane-1,2-diamine, has been investigated in Sprague Dawley SD rats in a repeated dose, reproductive and developmental screening study conducted according to OECD TG 422. In the study, three respective groups of male and female rats (10 rats per group) were administered the substance daily (5 days/week) at concentrations of 20, 60 or 180 mg/kg bw/day by oral gavage administration for at least five weeks.  Control groups received a reverse osmosis water vehicle. Only not severe effects were observed in female rats treated at 180 mg/kg bw/day during the last part of the lactation period and were expressed by a decrease in body weight gain and food consumption. The No Observed Adverse Effect Level (NOAEL) for the general systemic toxicity of the substance was determined to be 180 mg/kg bw/day.     Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Study conducted according to GLP and OECD Test Guidelines ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c34cd233-f018-447b-9a44-8c5f07db9661/documents/19441d4d-7deb-4d91-a1b4-5f38bca0f5ad_fed37888-c17c-4a24-80ff-929a1ceaa0b3.html,,,,,, "N1,N2-dimethyl-N1-{2-[methyl(propan-2-yl)amino]ethyl}-N2-(propan-2-yl)ethane-1,2-diamine",1042950-30-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c34cd233-f018-447b-9a44-8c5f07db9661/documents/19441d4d-7deb-4d91-a1b4-5f38bca0f5ad_fed37888-c17c-4a24-80ff-929a1ceaa0b3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,180 mg/kg bw/day,,rat "N1,N2-dimethyl-N1-{2-[methyl(propan-2-yl)amino]ethyl}-N2-(propan-2-yl)ethane-1,2-diamine",1042950-30-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c34cd233-f018-447b-9a44-8c5f07db9661/documents/0f869a52-77c9-4657-adab-d241ba629557_fed37888-c17c-4a24-80ff-929a1ceaa0b3.html,,oral,LD50,300 mg/kg bw,, "N1,N3-diallylpropane-1,3-diamine dihydrochloride",205041-15-2," Repeated dose toxicity studies by the oral, inhalation and dermal routes do not need to be conducted because the substance is only manufactured and used under strictly controlled conditions during its whole lifecycle and thus this endpoint does not need to be further investigated. For further details please refer to the report ""Exposure based adaptation information - N1,N3-diallylporpane-1,3-diamine dihydrochloride"" attached in IUCLID Chapter 13. However, according to the Commission Regulation (EU) 2021/979 of 17 June 2021, “Testing in accordance with Section 8.6.1 of Annex VIII may be omitted only for registrants producing less than 100 tonnes per year per manufacturer or importer, based on the exposure scenario(s) developed in the Chemical Safety Report”. This implies that testing in accordance with Section 8.6.1 is required for tonnages of >100 tonnes per year regardless of exposure. Therefore, a study according to OECD guideline 407 is initiated and will be submitted mid-2022. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ce3ea86-6d2d-4dbe-abcd-e0719466118f/documents/c2785146-3a11-4d5c-8086-094e5e922d48_1eafb609-61a4-439a-9384-fe0f4c9c87c6.html,,,,,, "N1,N3-diallylpropane-1,3-diamine dihydrochloride",205041-15-2," In an acute oral toxicity study conducted according to OECD TG 423, the LD50 cut-off in rats was determined to be 500 mg/kg bw. In addition, in an acute dermal toxicity study conducted according to OECD TG 402, the LD50 for acute dermal toxicity in rats was > 2000 mg/kg bw. Testing for acute inhalation toxicity was not performed because results from two routes of exposure are already provided and relevant exposure via the inhalation route is not very likely due to particle size and vapour pressure of the substance. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ce3ea86-6d2d-4dbe-abcd-e0719466118f/documents/35832bbd-25f5-4f9a-b86e-723c3c4841b0_1eafb609-61a4-439a-9384-fe0f4c9c87c6.html,,,,,, "N1,N3-diallylpropane-1,3-diamine dihydrochloride",205041-15-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ce3ea86-6d2d-4dbe-abcd-e0719466118f/documents/35832bbd-25f5-4f9a-b86e-723c3c4841b0_1eafb609-61a4-439a-9384-fe0f4c9c87c6.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "N1,N3-diallylpropane-1,3-diamine dihydrochloride",205041-15-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ce3ea86-6d2d-4dbe-abcd-e0719466118f/documents/35832bbd-25f5-4f9a-b86e-723c3c4841b0_1eafb609-61a4-439a-9384-fe0f4c9c87c6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, N-1-naphthylaniline,90-30-2," A subchronic oral repeated dose toxicity study in rat (90 -day key study) was conducted. Although the assigned study director considered the findings at the lowest dose as incidental and non-adverse, the evaluating MSCA considers the lowest tested dose of 5 mg/kg bw/day in this study as a LOAEL instead of a NOAEL, because at this level significantly increased bilirubin levels in plasma of exposed animals, extramedullary haematopoiesis and pigment storage in spleen, as well as bilirubin in urine and a significant increase in spleen weight was observed, indicative of a haemolytic anemia.In addition, the observed effects are considered to be dose-dependent starting at the lowest tested dose of 5 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30465aa3-db45-41b2-97ac-84b1bf5cd966/documents/719c1fa3-5970-48c5-ace8-326a4f5c18fb_bd2b4514-73c3-42d3-ace0-2b2f4d6e19ef.html,,,,,, N-1-naphthylaniline,90-30-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/30465aa3-db45-41b2-97ac-84b1bf5cd966/documents/719c1fa3-5970-48c5-ace8-326a4f5c18fb_bd2b4514-73c3-42d3-ace0-2b2f4d6e19ef.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,5 mg/kg bw/day,,rat N-1-naphthylaniline,90-30-2," Acute toxicity, oral LD50 (rat) = 1625 mg/kg bw (MacEwen and Vernot, 1974) LD50 (mouse) = 1231 mg/kg bw (MacEwen and Vernot, 1974) Acute toxicity, dermal LD50 (rabbit) > 5000 mg/kg bw (Weil, 1974) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30465aa3-db45-41b2-97ac-84b1bf5cd966/documents/ff1b5e8d-0918-486b-889c-6255d4de8eaf_bd2b4514-73c3-42d3-ace0-2b2f4d6e19ef.html,,,,,, N-1-naphthylaniline,90-30-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30465aa3-db45-41b2-97ac-84b1bf5cd966/documents/ff1b5e8d-0918-486b-889c-6255d4de8eaf_bd2b4514-73c3-42d3-ace0-2b2f4d6e19ef.html,,oral,LD50,"1,625 mg/kg bw",adverse effect observed, N-1-naphthylaniline,90-30-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30465aa3-db45-41b2-97ac-84b1bf5cd966/documents/ff1b5e8d-0918-486b-889c-6255d4de8eaf_bd2b4514-73c3-42d3-ace0-2b2f4d6e19ef.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, (S)-2-acetamido-N-benzyl-3-methoxypropanamide,175481-37-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/391bb6fc-d58a-449e-bdde-4c585eb3c32b/documents/8c1b8336-9afe-4a1e-9e40-feeaaaf9cabc_b81ab1ed-4ce1-4a75-b50d-09c18ab0c3c4.html,Chronic toxicity – systemic effects,oral,NOAEL,90 mg/kg bw/day,,rat "N2-Isobutyryl-5′-O-(4,4′-dimethoxytrityl)-2′-deoxyguanosine-3′-O-[O-(2-cyanoethyl)-N,N′-diisopropylphosphoramidite]",93183-15-4," No data is available for the target substance Guanosine, 5′-O-[bis(4-methoxyphenyl)phenylmethyl]-2′-deoxy-N-(2-methyl-1-oxopropyl)-, 3′-[2-cyanoethyl N,N-bis(1-methylethyl)phosphoramidite]. Thus, data from a suitable read-across partner was used to assess the acute oral toxicity of the target substance. In an acute oral toxicity study in rats conducted according to OECD 423, 5′-O-[bis(4-methoxyphenyl)phenylmethyl]-2′-deoxythymidine, 3′-[2-cyanoethyl N,N-bis(1-methylethyl)phosphoramidite] (source substance) was applied to rats. One animal out of six died at the limit dose of 2000 mg/kg bw. Based on the results, the LD50 can be considered to be greater 2000 mg/kg bw and the LD50 cut-off value was determined to be 2500 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9efd41bf-086f-419d-a76a-66fbb2a7d889/documents/e243618c-129c-4384-9b08-dc283115e730_000a43ba-4657-4ed1-a905-e657eb100d89.html,,,,,, "N4,N4'-hexane-1,6-diylbis[N-butyl-6-chloro-N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine]",83420-16-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The key study was well documented, and meets generally accepted scientific principles and was assigned a Klimisch score of 2. The overall quality of the database is high. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/610a65d8-994d-4832-8cf7-c4795b5ea948/documents/e9f735d1-663a-404a-90bb-127f95b2118a_5982d907-b46e-408b-beda-09dd89384c10.html,,,,,, "N4,N4'-hexane-1,6-diylbis[N-butyl-6-chloro-N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine]",83420-16-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/610a65d8-994d-4832-8cf7-c4795b5ea948/documents/e9f735d1-663a-404a-90bb-127f95b2118a_5982d907-b46e-408b-beda-09dd89384c10.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat "N4,N4'-hexane-1,6-diylbis[N-butyl-6-chloro-N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine]",83420-16-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): There is one key study available for acute oral toxicity and it is an OECD guideline/GLP study. The quality of the database is high. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): There is one key study available for acute inhalation toxicity and it is an OECD guideline/GLP study. The quality of the database is high. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/610a65d8-994d-4832-8cf7-c4795b5ea948/documents/6c583b36-b1bd-411c-a8ea-9c31ba9b9d91_5982d907-b46e-408b-beda-09dd89384c10.html,,,,,, "N4,N4'-hexane-1,6-diylbis[N-butyl-6-chloro-N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine]",83420-16-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/610a65d8-994d-4832-8cf7-c4795b5ea948/documents/6c583b36-b1bd-411c-a8ea-9c31ba9b9d91_5982d907-b46e-408b-beda-09dd89384c10.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "N4,N4'-hexane-1,6-diylbis[N-butyl-6-chloro-N,N'-bis(2,2,6,6-tetramethylpiperidin-4-yl)-1,3,5-triazine-2,4-diamine]",83420-16-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/610a65d8-994d-4832-8cf7-c4795b5ea948/documents/6c583b36-b1bd-411c-a8ea-9c31ba9b9d91_5982d907-b46e-408b-beda-09dd89384c10.html,,inhalation,LC50,380 mg/m3,adverse effect observed, "N4-Benzoyl-5′-O-(4,4′-dimethoxytrityl)-2′-deoxycytidine-3′-O-[O-(2-cyanoethyl)-N,N′-diisopropylphosphoramidite]",102212-98-6," No data is available for the target substance Cytidine, N-benzoyl-5′-O-[bis(4 methoxyphenyl)phenylmethyl]-2′-deoxy-, 3′-[2-cyanoethyl bis(1-methylethyl)phosphoramidite]. Thus, data from a suitable read-across partner was used to assess the acute oral toxicity of the target substance. In an acute oral toxicity study in rats conducted according to OECD 423, 5′-O-[bis(4-methoxyphenyl)phenylmethyl]-2′-deoxythymidine, 3′-[2-cyanoethyl N,N-bis(1-methylethyl)phosphoramidite] (source substance) was applied to rats. One animal out of six died at the limit dose of 2000 mg/kg bw. Based on the results, the LD50 can be considered to be greater 2000 mg/kg bw and the LD50 cut-off value was determined to be 2500 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/363c9fe2-d232-4bd3-b975-220dee3217a6/documents/1be4b085-9cb1-4dad-b251-aea56f5d10f0_8c2ab640-7e3c-43a8-95f7-066e92521f19.html,,,,,, "N6-Benzoyl-5′-O-(4,4′-dimethoxytrityl)-2′-deoxyadenosine-3′-O-[O-(2-cyanoethyl)-N,N′-diisopropylphosphoramidite]",98796-53-3," No data is available for the target substance N-benzoyl-5′-O-[bis(4-methoxyphenyl)phenylmethyl]-2′-deoxyadenosine, 3′-[2-cyanoethyl N,N-bis(1-methylethyl)phosphoramidite]. Thus, data from a suitable read-across partner was used to assess the acute oral toxicity of the target substance. In an acute oral toxicity study in rats conducted according to OECD 423, 5′-O-[bis(4-methoxyphenyl)phenylmethyl]-2′-deoxythymidine, 3′-[2-cyanoethyl N,N-bis(1-methylethyl)phosphoramidite] (source substance) was applied to rats. One animal out of six died at the limit dose of 2000 mg/kg bw. Based on the results, the LD50 can be considered to be greater 2000 mg/kg bw and the LD50 cut-off value was determined to be 2500 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d780474-6273-4474-bd24-01ff5d1b4644/documents/ca675791-1015-4246-8f2d-2d09e2c32324_77e67dc3-bfab-4bfe-930f-4cbd31dd7741.html,,,,,, N-acetylhexanelactam,1888-91-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Study is performed as OECD 421 guidline conform GLP study. Thus reliability is 1. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f930e6cc-d3f2-4089-9fa7-93d0a23ec199/documents/4f2c2f5a-1b04-4b98-9918-f353d55d8e68_402db81d-89ad-40ad-b60d-1c586dd97396.html,,,,,, N-acetylhexanelactam,1888-91-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f930e6cc-d3f2-4089-9fa7-93d0a23ec199/documents/4f2c2f5a-1b04-4b98-9918-f353d55d8e68_402db81d-89ad-40ad-b60d-1c586dd97396.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat N-acetylhexanelactam,1888-91-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is an GLP study rated Klimisch 1. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study is an GLP study rated Klimisch 1. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f930e6cc-d3f2-4089-9fa7-93d0a23ec199/documents/IUC5-b3dd1f65-4895-40e6-8508-6a5837feb10a_402db81d-89ad-40ad-b60d-1c586dd97396.html,,,,,, N-acetylhexanelactam,1888-91-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f930e6cc-d3f2-4089-9fa7-93d0a23ec199/documents/IUC5-b3dd1f65-4895-40e6-8508-6a5837feb10a_402db81d-89ad-40ad-b60d-1c586dd97396.html,,oral,LD50,"1,836 mg/kg bw",adverse effect observed, N-acetylhexanelactam,1888-91-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f930e6cc-d3f2-4089-9fa7-93d0a23ec199/documents/IUC5-b3dd1f65-4895-40e6-8508-6a5837feb10a_402db81d-89ad-40ad-b60d-1c586dd97396.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, N-acetylsulphanilyl chloride,121-60-8," Repeated Dose Toxicity (Oral): Based on all the available data, it was concluded that the test chemical did not show any adverse effects or systemic toxicity after repeated exposure to the test animals. Therefore, on the basis of all observations and results, it was concluded that the test chemical is not likely to classify under STOT-RE 1 or 2 category, as per the CLP criteria of classification and labelling. Repeated Dose Toxicity (Inhalation): A short term repeated inhalation toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the given test chemical has very low vapor pressure 3.34E-007 mm Hg at 25°C., so the potential for the generation of inhalable vapors is very low. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated inhalation toxicity was considered for waiver. Repeated Dose Toxicity (Dermal): A short term dermal toxicity study does not need to be conducted since the pH of the test chemical is 1.97, which indicates the test chemical is highly acidic in nature and is likely to be classified in 'Skin irritant Category 1' as per CLP criteria of classifcation and labeling. Therfore, this endpoint is considered as a 'Waiver'. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0eea17f-dc7c-47e6-b006-00f9384e9a14/documents/3487d0e3-86c0-4c40-bdf3-cc559a017efb_65bc1a48-14a6-4aa1-b289-3e20bbfa6ce2.html,,,,,, N-acetylsulphanilyl chloride,121-60-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0eea17f-dc7c-47e6-b006-00f9384e9a14/documents/3487d0e3-86c0-4c40-bdf3-cc559a017efb_65bc1a48-14a6-4aa1-b289-3e20bbfa6ce2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat N-acetylsulphanilyl chloride,121-60-8," Acute Oral Toxicity: Based on all the available data on the test chemical and also from the observations and results, it was concluded that the test chemical did not cause any mortalities, at doses above 2000 mg/kg bw and therefore is not likely to classify as a toxicant as per the CLP criteria of classification and labelling. Acute Dermal Toxicity: An acute dermal toxicity study does not need to be conducted since the pH of the test chemical is 1.97, which indicates the test chemical is highly acidic in nature and is likely to be classified in 'Skin irritant Category 1' as per CLP criteria of classifcation and labeling. Therfore, this endpoint is considered as a 'Waiver'. Acute Inhalation Toxicity: An acute inhalation toxicity study does not need to be conducted because exposure of humans via inhalation in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the given test chemical has very low vapor pressure 3.34E-007 mmHg at 25°C., so the potential for the generation of inhalable vapors is very low. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point for repeated inhalation toxicity was considered for waiver. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0eea17f-dc7c-47e6-b006-00f9384e9a14/documents/fbf7cebb-2665-4dbb-8238-591197a10749_65bc1a48-14a6-4aa1-b289-3e20bbfa6ce2.html,,,,,, N-acetylsulphanilyl chloride,121-60-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0eea17f-dc7c-47e6-b006-00f9384e9a14/documents/fbf7cebb-2665-4dbb-8238-591197a10749_65bc1a48-14a6-4aa1-b289-3e20bbfa6ce2.html,,oral,LD50,"3,200 mg/kg bw",no adverse effect observed, Naftidrofuryl,31329-57-4, Acute toxicity (oral): LD50 rat = 1890 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dabe5208-30cd-483b-9499-5040f2edb1aa/documents/1699be56-cabd-453b-ad87-b926337dcd47_b95cfa49-a471-4900-a721-66a735912829.html,,,,,, Naftidrofuryl,31329-57-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dabe5208-30cd-483b-9499-5040f2edb1aa/documents/1699be56-cabd-453b-ad87-b926337dcd47_b95cfa49-a471-4900-a721-66a735912829.html,,oral,LD50,"1,890 mg/kg bw",adverse effect observed, Nandrolone,434-22-0,"No acute toxicity studies with nandrolone are available. However, results of two subcutaneous acute toxicity studies are cited in RTECS database (Jan 2010):Subcutaneous (rat): TDLO = 1.2 mg/kg bw; exposure time 3 days[Acta Endrocrinologica (Copenhagen). (Periodica, Skolegade 12 E; DK-250 Valby Denmark) V.1-1948- v.47, p. 444, 1964 (ACENA7)]Subcutanous (rabbit): TDLO = 2 mg/kg bw; exposure time 5 days[Anatomical Record. (alan R. Liss, Inc., 41 E. 11th St., New York, NY 10003) V.1-1906/08- v. 142, p. 469, 1962 (ANREAK)]] ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62e695ac-26af-4f9a-beb0-8d9a8657f55f/documents/IUC5-26fe3004-a03b-411f-9b25-390e8bc5dcc2_6ec39f3f-df8d-421e-9e1d-3be4852e9284.html,,,,,, "Naphtha (petroleum), light polymn.",68783-11-9,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b17ebafe-48b7-4236-98c3-c288d2e947ed/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_4431eaf1-5465-458b-8957-6e511f459778.html,,,,,, "Naphtha (petroleum), light polymn.",68783-11-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b17ebafe-48b7-4236-98c3-c288d2e947ed/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_4431eaf1-5465-458b-8957-6e511f459778.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), light polymn.",68783-11-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b17ebafe-48b7-4236-98c3-c288d2e947ed/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_4431eaf1-5465-458b-8957-6e511f459778.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), light polymn.",68783-11-9," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b17ebafe-48b7-4236-98c3-c288d2e947ed/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_4431eaf1-5465-458b-8957-6e511f459778.html,,,,,, "Naphtha (petroleum), light polymn.",68783-11-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b17ebafe-48b7-4236-98c3-c288d2e947ed/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_4431eaf1-5465-458b-8957-6e511f459778.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light polymn.",68783-11-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b17ebafe-48b7-4236-98c3-c288d2e947ed/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_4431eaf1-5465-458b-8957-6e511f459778.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), light polymn.",68783-11-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b17ebafe-48b7-4236-98c3-c288d2e947ed/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_4431eaf1-5465-458b-8957-6e511f459778.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha (petroleum), polymn.",64741-72-6,"28-day repeated dose toxicity, dermal - Systemic NOAEL= 5 ml/kg, or approximately 3750 mg/kg (OECD TG 410 under occlusive conditions)28-day repeated dose toxicity, inhalation - Systemic NOAEC=2050 ppm, or approximately  9840 mg/3 (OECD TG 412)90-day repeated dose toxicity, inhalation - Systemic NOAEC>20,000 mg/m3. Local NOAEC = 10,000 mg/m3 (OECD TG 413).Chronic toxicity, inhalation - Systemic NOAEC=292 ppm, or approximately 1400 mg/m3  (OECD 453) ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc9a8c6a-5538-4bc0-a6f0-999c6a1fee15/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_f03905a0-b263-4f08-8292-dc2b1c9a7429.html,,,,,, "Naphtha (petroleum), polymn.",64741-72-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc9a8c6a-5538-4bc0-a6f0-999c6a1fee15/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_f03905a0-b263-4f08-8292-dc2b1c9a7429.html,Chronic toxicity – systemic effects,dermal,NOAEL,375 mg/kg bw/day,,mouse "Naphtha (petroleum), polymn.",64741-72-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc9a8c6a-5538-4bc0-a6f0-999c6a1fee15/documents/046f4854-a553-48fe-81f1-7ff3951b3cb5_f03905a0-b263-4f08-8292-dc2b1c9a7429.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,402 mg/m3",,rat "Naphtha (petroleum), polymn.",64741-72-6," The acute toxicity of members of the low boiling point naphtha category has been investigated in a large number of animal studies (44 oral/dermal and 38 inhalation). Around 20 individual CAS RNs from the category have been tested, and the acute toxicity can be summarised as follows: Acute toxicity – Oral LD50 > 5000 mg/kg (OECD TG 401) Acute toxicity – Dermal LD50 > 2000 mg/kg (OECD TG 402 under occlusive conditions) Acute toxicity – Inhalation LC50 > 5610 mg/m3 (OECD TG 403) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc9a8c6a-5538-4bc0-a6f0-999c6a1fee15/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_f03905a0-b263-4f08-8292-dc2b1c9a7429.html,,,,,, "Naphtha (petroleum), polymn.",64741-72-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc9a8c6a-5538-4bc0-a6f0-999c6a1fee15/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_f03905a0-b263-4f08-8292-dc2b1c9a7429.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), polymn.",64741-72-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc9a8c6a-5538-4bc0-a6f0-999c6a1fee15/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_f03905a0-b263-4f08-8292-dc2b1c9a7429.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphtha (petroleum), polymn.",64741-72-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc9a8c6a-5538-4bc0-a6f0-999c6a1fee15/documents/3b7bce1d-9b99-4c9c-bea8-8e635ac147e8_f03905a0-b263-4f08-8292-dc2b1c9a7429.html,,inhalation,LC50,"5,610 mg/m3",no adverse effect observed, "Naphtha, thermal cracked, residues, naphthalene cut",85117-10-8,"There are limited repeat dose toxicity data on any of the specific streams identified for this category. However, there are substantial data on the repeated dose toxicity of a number of specific components present in some streams i.e. benzene, toluene, ethylbenzene and styrene which demonstrate significant target organ toxicity. Classification will be required for streams that contain benzene or toluene at concentrations greater than or equal to 1%or 10% respectively. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f16157bf-608b-4f98-a40a-7bec9911d6ca/documents/IUC5-429ff41c-88a2-4fb9-8fcb-3fb335fdf184_22aa064d-ceb5-4dfa-ab57-175f75761ccf.html,,,,,, "Naphtha, thermal cracked, residues, naphthalene cut",85117-10-8,"Available data for 4 specific streams within this category [Carbon Black Oil (CAS 64742-90-1), E000014200 (CAS 68475-80-9), Rohnaphthalin-Gemisch (CAS 85117-10-8), Quenchoel (CAS 98072-36-7)], further information included in the Category Summary for Fuel Oils Category (ACC, 2005), and on specific components (benzene, toluene, ethylbenzene, styrene, naphthalene, biphenyl and anthracene) that are present in some streams indicate that acute toxicity is expected to be low. Naphthalene has been shown to be acutely toxic (producing haemolytic anaemia) in humans following oral exposure and ethylbenzene and styrene are hazardous following acute inhalation exposure. Therefore, classification will be required for streams containing a high proportion of naphthalene (≥25%) and styrene (>12.5%) but the highest concentration of ethylbenzene (10%) is too low to trigger classification. Following acute inhalation exposures to toluene in humans a number of subjective sensations such as headache, dizziness, feeling of intoxication, irritation and sleepiness and decreases in acute neurobehavioural performance are seen. The NOAEC for acute neurobehavioural effects in humans is 50 ppm (188 mg/m3) and classification (R67/H336) will be required for streams containing ≥20% toluene. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f16157bf-608b-4f98-a40a-7bec9911d6ca/documents/IUC5-89a3f6d3-6024-4d68-8e71-8b36a48f74e7_22aa064d-ceb5-4dfa-ab57-175f75761ccf.html,,,,,, "Naphthalene-2,6-dicarboxylic acid",1141-38-4," For the repeated dose toxicity study in rats following effects were noted: SYSTEMIC TOXICITY In the 100 and 300 mg/kg group, neither sex nor effect of test substance administration was observed. In the 1000 mg/kg group, there was a significant low value in body weight gain in female gestation period, significant high value in female liver weight in non-crossing group, significant low value in reticulocyte count in main test group, non-crossing group, meaningfully low values for red blood cell count, mean red blood cell volume and mean red blood cell hemoglobin level were found to be significantly high. Therefore, the no-effect level (NOEL) and the non-toxicity level (NOAEL) for repeated dose toxicity of 2,6-naphthalene dicarboxylic acid under this test condition were 1000 mg/kg/day for male and 300 mg/kg/day for female, respectively.   NEUROTOXICITY No treatment-related effects in the FOB and Motor Assessments were observed in any dose group. As such the NOAEL for FOB and Motor Assessments is 1000 mg/kg/day.   REPRODUCTIVE AND DEVELOPMENTAL TOXICITY In the fertility examination, up to the 1000 mg/kg group, the incidence of sexual cycle abnormality, the estrus period interval and the number of estrus, the copulation rate, the conception rate, the number of days required for copulation, the number of pregnant lutea body, the number of implantation, the implantation rate, the birth rate , gestation period, birth rate, number of births, number of surviving pups and number of dead pups in childbirth, and nursing rate on 4th day of nursing did not show any changes related to the administration of the test substance. In the newborn's body weight, general condition, survival rate, sex ratio and necropsy findings, no changes related to the administration of the test substance were observed up to the 1000 mg/kg group. As described above, no changes related to administration of the test substance were observed in the reproductive capacity and neonatal development of the parent animal up to the 1000 mg/kg group, so that the parent animal of 2,6-naphthalene dicarboxylic acid (NOEL) and non - toxic level (NOAEL) for reproduction and NOEL and non-toxic dose (NOAEL) for neonatal development were all considered to be 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06be49c4-966d-46af-a6ea-ff0f225fcb3c/documents/6d421882-9961-4163-9c79-78aade74aa63_ce0e07d7-609d-4edb-b8cb-409e64831dc1.html,,,,,, "Naphthalene-2,6-dicarboxylic acid",1141-38-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06be49c4-966d-46af-a6ea-ff0f225fcb3c/documents/6d421882-9961-4163-9c79-78aade74aa63_ce0e07d7-609d-4edb-b8cb-409e64831dc1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Naphthalene-2,6-dicarboxylic acid",1141-38-4, Low acute acute oral toxicity to rats was observed in a limit test. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06be49c4-966d-46af-a6ea-ff0f225fcb3c/documents/6d137d90-d1e0-44c6-90b4-391ad2c29b09_ce0e07d7-609d-4edb-b8cb-409e64831dc1.html,,,,,, "Naphthalene-2,6-dicarboxylic acid",1141-38-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06be49c4-966d-46af-a6ea-ff0f225fcb3c/documents/6d137d90-d1e0-44c6-90b4-391ad2c29b09_ce0e07d7-609d-4edb-b8cb-409e64831dc1.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Naphthalene-2,6-dicarboxylic acid",1141-38-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06be49c4-966d-46af-a6ea-ff0f225fcb3c/documents/6d137d90-d1e0-44c6-90b4-391ad2c29b09_ce0e07d7-609d-4edb-b8cb-409e64831dc1.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphthalene-2,6-dicarboxylic acid",1141-38-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06be49c4-966d-46af-a6ea-ff0f225fcb3c/documents/6d137d90-d1e0-44c6-90b4-391ad2c29b09_ce0e07d7-609d-4edb-b8cb-409e64831dc1.html,,inhalation,LC50,730 mg/m3,no adverse effect observed, "Naphthalenesulfonic acid, bis(1-methylethyl)-, Me derivs., sodium salts",68909-82-0," The combined repeated dose oral toxicity and reproduction/ developmental toxicity screening test with Naphthalenesulfonic acid, bis(1-methylethyl)-,methyl derivs., sodium salt(C7-alkyl naphthalene sulphonate)in male and female Wistar rats with dose levels of 30, 200, and 500/700 mg/kg body weight resulted to a NOAEL for general toxicity in male of 30 mg/kg bw/day and in female of 200 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc8c0081-ced7-46a0-9100-a7ceb555a2ee/documents/368f7d83-edd4-478b-9898-52f1b353ce3c_bf7a0bde-a681-45f1-aa4c-6fddedb13801.html,,,,,, "Naphthalenesulfonic acid, bis(1-methylethyl)-, Me derivs., sodium salts",68909-82-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc8c0081-ced7-46a0-9100-a7ceb555a2ee/documents/368f7d83-edd4-478b-9898-52f1b353ce3c_bf7a0bde-a681-45f1-aa4c-6fddedb13801.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "Naphthalenesulfonic acid, bis(1-methylethyl)-, Me derivs., sodium salts",68909-82-0," Acute toxicity testing (OECD 423) of Bis(1-methylethyl)-, methyl naphthalenesulfonate, sodium salt resulted to an Oral LD50 cut-off 500mg/ kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc8c0081-ced7-46a0-9100-a7ceb555a2ee/documents/8d814f84-ae57-40f3-a069-8c67f2ba2a63_bf7a0bde-a681-45f1-aa4c-6fddedb13801.html,,,,,, "Naphthalenesulfonic acid, bis(1-methylethyl)-, Me derivs., sodium salts",68909-82-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc8c0081-ced7-46a0-9100-a7ceb555a2ee/documents/8d814f84-ae57-40f3-a069-8c67f2ba2a63_bf7a0bde-a681-45f1-aa4c-6fddedb13801.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "calcium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate)",1474044-79-5," In the original submission of this dossier, a testing proposal was included for conducting a 90 -day oral toxicity study on the substance. In a decision finalized on November 25, 2015, ECHA instructed the registrant to conduct an OECD 408 oral gavage study on rats. This updated submission includs the results of the study. Rats (10/sex/dose) were exposed to the substance by gavage for a period of 90 days (doses 0, 100, 300 and 1000 mg/kg bw). Detailed examinations related to mortality, clinical signs, body weight, food consumption, ophthalmoscopy, behavioural effects, haematology, clinical chemistry, macroscopy, histopathology and organ weights were performed in a study that is performed according to OECD 408. In the highest dose group 6/10 females died showing alterations in the gastro-intestinal tract, a small thymus and bone marrow atrophy. The surviving females at 1000 mg/kg bw showed similar effects and a reduced body weight (gain). The effects on the gastro-intestinal tract also became apparent in males at 300 and 1000 mg/kg bw. These animals also had a reduced body weight (gain). Other effects included changes in numbers of white blood cells, lymphocytes, platelets as well as effects on several biochemical parameters. Macroscopy and histopathology indicated that next to the GI-tract mainly the thymus and bone marrow could be considered as potentially affected in males at 300 mg/kg bw and above and in females at 1000 mg/kg bw. The NOAEL as derived from this study is 100 mg/kg bw. In addition to this study as study according to DNNSA (di C8-C10, branched, C9 rich, alkylnaphthalene sulphonic acid) provides reliable read-across. The NOAEL for DNNSA in this study is 95 mg/kg/day based on local effects to the gastro-intestinal tract. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7072e58d-82c4-4ecb-a8c7-a1f458ca9986/documents/89521cc6-bbd5-41ac-833c-c0cefa044753_3d638834-10e9-42f6-9ff1-e6b3b45cc8e8.html,,,,,, "calcium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate)",1474044-79-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7072e58d-82c4-4ecb-a8c7-a1f458ca9986/documents/89521cc6-bbd5-41ac-833c-c0cefa044753_3d638834-10e9-42f6-9ff1-e6b3b45cc8e8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "calcium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate)",1474044-79-5," The oral LD50 is > 2500 mg/kg. The dermal LD50 is > 10,000 mg/kg. The use as additive is unlikely to result in significant human exposure to inhalable droplets. In addition, a 1 hour exposure at 9 mg/L did not cause mortality. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7072e58d-82c4-4ecb-a8c7-a1f458ca9986/documents/IUC5-30e227bb-9f7f-4fe9-b77a-2087f99eaeed_3d638834-10e9-42f6-9ff1-e6b3b45cc8e8.html,,,,,, "calcium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate)",1474044-79-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7072e58d-82c4-4ecb-a8c7-a1f458ca9986/documents/IUC5-30e227bb-9f7f-4fe9-b77a-2087f99eaeed_3d638834-10e9-42f6-9ff1-e6b3b45cc8e8.html,,oral,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "calcium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate)",1474044-79-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7072e58d-82c4-4ecb-a8c7-a1f458ca9986/documents/IUC5-30e227bb-9f7f-4fe9-b77a-2087f99eaeed_3d638834-10e9-42f6-9ff1-e6b3b45cc8e8.html,,dermal,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "calcium bis(di C8-C10, branched, C9 rich, alkylnaphthalenesulphonate)",1474044-79-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7072e58d-82c4-4ecb-a8c7-a1f458ca9986/documents/IUC5-30e227bb-9f7f-4fe9-b77a-2087f99eaeed_3d638834-10e9-42f6-9ff1-e6b3b45cc8e8.html,,inhalation,discriminating conc.,"9,000 mg/m3",no adverse effect observed, "Naphthalenesulfonic acids, branched and linear Bu derivs., sodium salts",91078-64-7,"Repeated dose toxicity - oral NOAEL (28 days, male)= 500 ppm (93.75 mg/kg bw/day) NOAEL (28 days, famale) = 2500 ppm NOAEL (90 days ) = 175 mg/kg bw/day Repeated dose toxicity - inhalation  NOAEC (28 days) = 0.8 mg/m3 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3750ab4e-9791-4cef-b6cb-7ee43d24b1bb/documents/968c600e-fb75-4281-87a4-86807bce23cb_5e39040e-b9e4-4b9f-a227-252f7e4dc842.html,,,,,, "Naphthalenesulfonic acids, branched and linear Bu derivs., sodium salts",91078-64-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3750ab4e-9791-4cef-b6cb-7ee43d24b1bb/documents/968c600e-fb75-4281-87a4-86807bce23cb_5e39040e-b9e4-4b9f-a227-252f7e4dc842.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,93.75 mg/kg bw/day,,rat "Naphthalenesulfonic acids, branched and linear Bu derivs., sodium salts",91078-64-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3750ab4e-9791-4cef-b6cb-7ee43d24b1bb/documents/968c600e-fb75-4281-87a4-86807bce23cb_5e39040e-b9e4-4b9f-a227-252f7e4dc842.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,0.8 mg/m3,,rat "Naphthalenesulfonic acids, branched and linear Bu derivs., sodium salts",91078-64-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3750ab4e-9791-4cef-b6cb-7ee43d24b1bb/documents/968c600e-fb75-4281-87a4-86807bce23cb_5e39040e-b9e4-4b9f-a227-252f7e4dc842.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,175 mg/kg bw/day,,rat "Naphthalenesulfonic acids, branched and linear Bu derivs., sodium salts",91078-64-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3750ab4e-9791-4cef-b6cb-7ee43d24b1bb/documents/968c600e-fb75-4281-87a4-86807bce23cb_5e39040e-b9e4-4b9f-a227-252f7e4dc842.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.8 mg/m3,adverse effect observed,rat "Naphthalenesulfonic acids, branched and linear Bu derivs., sodium salts",91078-64-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3750ab4e-9791-4cef-b6cb-7ee43d24b1bb/documents/d6ff011e-2b33-4c4d-bf7c-f7aa08ac320c_5e39040e-b9e4-4b9f-a227-252f7e4dc842.html,,oral,LD50,"1,790 mg/kg bw",adverse effect observed, "Naphthalenesulfonic acids, branched and linear Bu derivs., sodium salts",91078-64-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3750ab4e-9791-4cef-b6cb-7ee43d24b1bb/documents/d6ff011e-2b33-4c4d-bf7c-f7aa08ac320c_5e39040e-b9e4-4b9f-a227-252f7e4dc842.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, "Naphthalenesulfonic acids, branched and linear Bu derivs., sodium salts",91078-64-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3750ab4e-9791-4cef-b6cb-7ee43d24b1bb/documents/d6ff011e-2b33-4c4d-bf7c-f7aa08ac320c_5e39040e-b9e4-4b9f-a227-252f7e4dc842.html,,inhalation,LC50,"3,820 mg/m3",adverse effect observed, Naphthenic acids,1338-24-5," Repeated dose toxicity study in rats (90 days, diet): A 90 -day repeated dose toxicity study was performed according to OECD 408 on Wistar rats administered with naphthenic acid at 3 dose levels for 90 days (1500 ppm, 4200 ppm and 12500 ppm, actual intake 107, 302 and 881 mg/kg bw/day, resp.) by oral feed (key, K1; Weisz, 2018). The no observed adverse effect level (NOAEL) for naphthenic acid is considered to be 302 mg/kg bw /day for the combined sexes (289 mg/kg bw/day for males and 316 mg/kg bw/day for females). Combined repeated dose/ reproductive and developmental toxicity: A supporting combined repeated dose/reproductive and developmental toxicity study performed according to OECD 422 was available for naphthenic acid (supporting, K1; HPVIS, 2010). The NOAEL for systemic toxicity was 100 mg/kg bw/day, whereas NOAEL for neurotoxicity was 900 mg/kg bw, both in male and female rats. Overall, it is questioned whether the route of exposure in the OECD 422 study (oral gavage) had did not influence the NOAEL via the induction of a bolus dose. As no effects were observed at 302 mg/kg bw/d in the 90d repeated dose toxicity study (oral diet), this dose level is considered for further safety assessment. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ebe750c6-dcbc-4205-bf9f-21fc7033b59a/documents/IUC5-9c46cda8-30a2-4257-aa7d-5d796290f946_0c73611a-92dd-489e-a105-8643eec97bae.html,,,,,, Naphthenic acids,1338-24-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ebe750c6-dcbc-4205-bf9f-21fc7033b59a/documents/IUC5-9c46cda8-30a2-4257-aa7d-5d796290f946_0c73611a-92dd-489e-a105-8643eec97bae.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,302 mg/kg bw/day,,rat Naphthenic acids,1338-24-5,"For acute oral toxicity no key study could be put forward. Instead the available studies were considered in a Weight of Evidence approach, all resulting in LD50 values above limit dose (3.0 - 5.88 g/kg bw). From the available studies the most detailed study was kept as for the chemical safety assessment. For acute dermal toxicity the LD50 was obtained from 2 studies, both showing LD50 values above limit dose (3.16 & 20.0 g/kg bw).The study with the lowest values was considered as Key study and the other served as supporting study. The endpoint acute inhalation toxicity has been waived based on the very low vapour pressure of the substance. Inhalation exposure is very unlikely under normal handling and use. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebe750c6-dcbc-4205-bf9f-21fc7033b59a/documents/IUC5-645761ac-54fa-41d1-a42b-00a5502f7cad_0c73611a-92dd-489e-a105-8643eec97bae.html,,,,,, Naphthenic acids,1338-24-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebe750c6-dcbc-4205-bf9f-21fc7033b59a/documents/IUC5-645761ac-54fa-41d1-a42b-00a5502f7cad_0c73611a-92dd-489e-a105-8643eec97bae.html,,oral,LD50,"5,880 mg/kg bw",no adverse effect observed, Naphthenic acids,1338-24-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebe750c6-dcbc-4205-bf9f-21fc7033b59a/documents/IUC5-645761ac-54fa-41d1-a42b-00a5502f7cad_0c73611a-92dd-489e-a105-8643eec97bae.html,,dermal,LD50,"3,160 mg/kg bw",no adverse effect observed, "Naphthenic acids, bismuth salts",85736-59-0," The source substance bismuth hydroxy nitrate oxide was found being uncritical in a sub-chronic oral toxicity test (OECD 408, NOAEL = 1000 mg/kg bw/d), equivalent to ~3.4 mmol Bi/kg bw/d (based on Bi5H9N4O22). In s sub-acute oral toxicity study with naphthenic acids grades, a NOAEL of 100 mg/kg bw/d was determined (equivalent to 0.44 mmol naphthenic acids/kg bw/d, calculated based on an average of C14, 1-ring naphthenic acid as average value). Considering a bismuth content in the target substance of 26.4% as determined and the naphthenic acids, making up the remaining 73.6% as bound and residual free naphthenic acids, the calculated theoretical NOAEL is derived as 100 mg/kg bw/d * 100% / 73.6% ≈ 136 mg/kg bw/d (and the LOAEL at ~ 400 mg/kg bw/d). This conservative approach assumes that all naphthenic acids, those bound to bismuth as well as the excess free naphthenic acids, were bioavailable, contributing to systemic toxicity. This value will be taken forward for hazard and risk assessment. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36e1d99e-b0d8-4bee-98c4-06672def344e/documents/8862ec2f-116e-44ce-b6a0-bf40c56a14e2_ed95e412-cd12-41b7-b929-7df27a385ada.html,,,,,, "Naphthenic acids, bismuth salts",85736-59-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36e1d99e-b0d8-4bee-98c4-06672def344e/documents/8862ec2f-116e-44ce-b6a0-bf40c56a14e2_ed95e412-cd12-41b7-b929-7df27a385ada.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,136 mg/kg bw/day,,rat "Naphthenic acids, bismuth salts",85736-59-0," Based on data from bismuth compounds and naphthenic acids, all showing low oral and dermal toxicity, in a read-across approach to the cationic and anionic moieties of the target substance naphthenic acids, bismuth salts are considered not acutely toxic by oral and dermal route. Given the low vapour pressure of the substance (< 1 Pa) and the high molecular mass (~ 850 Dalton) exposure by inhalation is very unlikely. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36e1d99e-b0d8-4bee-98c4-06672def344e/documents/80d6b3d4-df91-4f14-ac88-c35488e32a25_ed95e412-cd12-41b7-b929-7df27a385ada.html,,,,,, "Naphthenic acids, bismuth salts",85736-59-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36e1d99e-b0d8-4bee-98c4-06672def344e/documents/80d6b3d4-df91-4f14-ac88-c35488e32a25_ed95e412-cd12-41b7-b929-7df27a385ada.html,,oral,LD50,"3,768 mg/kg bw",no adverse effect observed, "Naphthenic acids, bismuth salts",85736-59-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36e1d99e-b0d8-4bee-98c4-06672def344e/documents/80d6b3d4-df91-4f14-ac88-c35488e32a25_ed95e412-cd12-41b7-b929-7df27a385ada.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphthenic acids, cobalt salts",61789-51-3,"Acute oral toxicity: LD50 (female rats): 3129 mg/kg bw (approx. 95% CL: 1750 - 5000 mg/kg) (OECD 425; GLP compliant) Acute toxicity, dermal:Conduct of an acute dermal toxicity study is unjustified since dermal uptake is considered negligible (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006).Acute toxicity, inhalation:The classification from the acute oral toxicity is read-across to the acute toxicity via inhalation. Further results from the ongoing testing programme will be included upon availability. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43bc3c76-5fe6-48c6-a715-3ab889b6f8a2/documents/8403859b-ac6f-440a-a9e2-923242616c9f_76717d28-a2c6-4b19-9210-bee172c97285.html,,,,,, "Naphthenic acids, cobalt salts",61789-51-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/43bc3c76-5fe6-48c6-a715-3ab889b6f8a2/documents/8403859b-ac6f-440a-a9e2-923242616c9f_76717d28-a2c6-4b19-9210-bee172c97285.html,,oral,LD50,"3,129 mg/kg bw",no adverse effect observed, "Naphthenic acids, copper salts",1338-02-9,"No repeated dose toxicity study with naphthenic acids, copper salts is available, thus the repeated dose toxicity will be addressed with existing data on the individual assessment entities copper and naphthenic acids. In relevant and reliable repeated dose toxicity studies for both moieties of naphthenic acids, copper salts, there were no toxicological findings reported that would justify a classification for specific target toxicity with repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34645ba5-9f80-4c4d-ab7f-e91be436bfab/documents/35c7de0f-da93-4c72-ae27-d7f4c3789c7b_40238e25-c420-48d5-8c94-a9a747aff0bc.html,,,,,, "Naphthenic acids, copper salts",1338-02-9,"The experimentally measured oral LD50 for naphthenic acids, copper salts is >2000 mg/kg bw, hence the substance would not need to be classified according to Regulation (EC) 1272/2008 for acute oral toxicity as well as for specific target organ toxicity, single exposure (STOT SE). However, naphthenic acids, copper salts is legally classified (Regulation 1272/2008; Index No. 029-003-00-5) for acute oral toxicity category 4 (H302). No acute dermal toxicity studies with naphthenic acids, copper salts are available, thus the acute toxicity will be addressed with existing data on the dissociation products copper and naphthenate ions. Signs of acute dermal toxicity are not expected for naphthenic acids, copper salts, since the LD50 for both constituents (copper and naphthenic acids) is above 2000 mg/kg bw. Based on the above given information naphthenic acids, copper salts is not expected to show any acute toxic effects via dermal route and does not require a classification for acute dermal toxicity (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34645ba5-9f80-4c4d-ab7f-e91be436bfab/documents/d4c9acce-2293-4a70-a346-b324a9c6f760_40238e25-c420-48d5-8c94-a9a747aff0bc.html,,,,,, "Naphthenic acids, copper salts",1338-02-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34645ba5-9f80-4c4d-ab7f-e91be436bfab/documents/d4c9acce-2293-4a70-a346-b324a9c6f760_40238e25-c420-48d5-8c94-a9a747aff0bc.html,,oral,LD50,"> 2,000 mg/kg bw",adverse effect observed, "Naphthenic acids, lithium salts",61788-56-5,"There are no data for lithium naphthenate. Data from appropriate read across substances are presented, with data on lithium carboxylate salts (lithium myristate, fatty acids C16-18 lithium salts, fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts, lithium 12-hydroxystearate) and naphthenic acids for oral exposure and data for fatty acids C18 (unsaturated) lithium salts for dermal exposure.   Oral Naphthenic acids In a combined repeated dose toxicity and reproduction/developmental toxicity screening study, conducted according to OECD Test Guideline 422 and to GLP, Sprague-Dawley rats (12/sex/group) were orally administered a mixture of naphthenic acids by stomach tube (gavage, in corn oil) at doses of 0, 100, 300 or 900 mg/kg bw/day. Males were dosed for 28 days while females were dosed for a total of 39-53 days. Assessment included clinical and cage-side observations, food consumption and body weight, haematology and clinical chemistry (but no urinalysis), neurobehavioural examination, organ weights, gross pathology and histopathological examination of a wide-range of organs and tissues. A statistically significant increase in liver weight was observed in the mid- (males only) and high-dose groups; kidney weight was significantly elevated in males at the high dose. Reduced growth (not statistically significant), associated with reduced food consumption (statistically significant), was apparent in high-dose animals. Clinical observations and mortality (females only) as well as slight haemoglobin reductions and pale kidneys in males were also observed at 900 mg/kg bw/day. Additional effects on the liver, thyroid and kidney were considered either adaptive, compensatory or not relevant for humans. There were no treatment-related effects at the lowest tested dose and no neurobehavioural effects in any group. On this basis, the NOAEL for general systemic toxicity was established as 100 mg/kg bw/day, while the NOAEL for neurotoxicity was 900 mg/kg bw/day (HPVIS, 2010). [See Effects on fertility and Effects on developmental toxicity sections for further details].   In a limited non-guideline subchronic toxicity study, female Wistar rats (12/group) were gavaged (in water) with a mixture of naphthenic acids (isolated from Athabasca oil sands) at doses of 0, 0.6, 6 or 60 mg/kg bw/day on 5 days/week for 90 days. Relative liver, kidney and brain weights were increased in the high-dose group. Biochemical analysis revealed elevated blood amylase and hypocholesterolaemia in high-dose rats, while hepatic glycogen accumulation was also observed in five animals in this group. These results implicated the liver as a potential target organ. The study NOAEL was set at 6 mg/kg bw/day (Rogers et al., 2002). Another non-guideline investigation involved the repeated oral [presumably gavage] administration of a mixture of naphthenic acids to male mice at 1000 mg/kg bw/day for 30 days. Observed effects included a few cases of CNS depression (without analgesia and no loss of the corneal reflex), haematological changes, weight loss leading eventually to death due to respiratory arrest, gross morphological changes in the liver and stomach, and microscopic changes in a few selected organs (Pennisi and Lynch, 1981).   Lithium   Lithium myristate was tested in an OECD Test Guideline 422 combined repeated dose and reproduction/developmental toxicity screening study in rats. Lithium myristate was administered via oral gavage for at least 28 days at doses of 0, 50, 150 and 500 mg/kg/day, which were based on effects from a dose range finding study. Minor effects were observed in parental animals on body weight gains, water consumption, clinical chemistry parameters and microscopic lesions in the stomach, spleen and liver at 500 mg/kg/day. These effects were all considered non-adverse. Therefore, the NOAEL of the study was determined to be at least 500 mg/kg/day.   Fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts was tested in an OECD Test Guideline 422 combined repeated dose and reproduction/developmental toxicity screening study in rats. The substance was administered via oral gavage for at least 28 days at doses of 0, 75, 250 and 750 mg/kg/day. Effects were observed at 750 mg/kg/day on mortality, reduced body weight and food consumption and kidney histopathology. The No Observed Adverse Effect Level of the study was determined to be 250 mg/kg/day.   Fatty acids C16-18 lithium salts was tested in an OECD Test Guideline 422 combined repeated dose and reproduction/developmental toxicity screening study in rats. Fatty acids C16-18 lithium salts was administered via oral gavage for at least 28 days at doses of 0, 50, 150 and 500 mg/kg/day, which were based on effects from a dose range finding study. No significant treatment related adverse effects were observed at the highest concentration of 500 mg/kg/day tested in the main study, so the parental NOAEL was 500 mg/kg/day for short-term repeat dose toxicity.   Lithium 12 -hydroxystearate was tested in an OECD Test Guideline 422 combined repeated dose and reproduction/developmental toxicity screening study in rats. Lithium 12-hydroxystearate was administered via the diet at concentrations of 0 (control), 600, 2000 and 6000 ppm, which were based on effects from a dose range finding study. Corresponding dose levels were calculated to be 43, 144 and 382 mg/kg/day in males, 47, 161 and 437 mg/kg/day in main group females and 363 mg/kg/day in recovery group females. Effects were observed on parental bodyweights, therefore, the NOAEL of the study was determined to be 2000 ppm (144 and 161 mg/kg/day for males and females, respectively).   Conclusion for oral toxicity   In an OECD Test Guideline 422 combined repeated dose and reproduction/developmental toxicity screening study in rats, conducted to GLP, a mixture of naphthenic acids was administered by gavage for at least 28 days at doses of 0, 100, 300 or 900 mg/kg bw/day. Treatment-related adverse effects were observed in the mid- and high-dose animals (including increased organ weights and decreased food consumption and growth). The NOAEL for systemic toxicity was established as 100 mg/kg bw/day (HPVIS, 2010). As the NOAEL of 100 mg/kg bw/day for naphthenic acids is lower than the NOAELs derived for the lithium cation (NOAELs ranging from 144/161 mg/kg/day (lithium 12-hydroxystearate) to 500 mg/kg bw/day (fatty acids C16-18 lithium salts and lithium myristate)), this value was taken as a worst-case scenario.    ​ Inhalation Lithium naphthenate is exclusively produced and used directly in grease form. It has a vapour pressure of less than 0.0025 Pa and a melting point of greater than 131°C, so the potential for the generation of inhalable forms is low. The use of the grease forms will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. In accordance with REACH Regulation, Annex IX, 8.6.2, column 2 as well as Annex XI, 1, the performance of additional repeated dose toxicity studies is not justified due to exposure considerations.   Dermal A key subacute toxicity and reproductive toxicity screen, using the OECD 422 study design, was conducted in rats on fatty acids C18 (unsaturated) lithium salts via dermal administration. The test material was administered at dose levels of 0, 100, 300 and 1000 mg/kg bw/day nominal, equating to 111.25, 345 and 1089.75 mg/kg bw/day by analysis, and were based on local dermal effects from a dose range finding study. There was a 2-week post-dose observation period for satellite high dose level and control groups. No systemic toxicity directly related to the administration of the substance was observed, although dose-related local effects were seen in the skin of treated animals in the 300 and 1000 mg/kg bw/day groups. Since the highest dose of 1089.75 mg/kg bw/day was essentially equivalent to a ‘limit dose’ and was considered to be the systemic NOAEL, this lithium fatty acid salt is not considered to be systemically hazardous. A local NOAEL of 111.25 mg/kg bw/day was determined due to dermal changes seen at higher concentrations.   Data on fatty acids C18 (unsaturated) lithium salts shows dose responsive localized dermal effects at the test site (dorsal surface), consisting of scabbed post dose findings and elevated dermal scores. These findings were most pronounced at 1000 mg/kg/day and were seen most frequently at this dose level. The findings at 300 mg/kg/day were at a lower incidence and with lower dermal scores. Dermal scores and findings at 100 mg/kg/day were comparable to the controls.   The experimental results from the repeated dose dermal toxicity study on fatty acids C18 (unsaturated) lithium salts gave a NOAEL of 1089.75 mg/kg bw/day applied to the skin (equivalent to 26.26 mg lithium/kg bw/day) but the degree of absorption was not quantified. If a default absorption of 10% is assumed, then the systemic NOAEL is 2.62 mg lithium/kg bw/day.   The results from this study also permitted consideration of long term local effects on the skin. The NOAEL for this effect was 111.25 mg/kg/day, which converts to 0.86 mg/cm2 based on the area of rat skin exposed in the subacute study (average weight of the rats in the study was 311 g, the body surface area was calculated as being approximately 9.1 x bw(g)0.66, and the approximate surface area exposed was 10%).   The lack of systemic toxicity when C18 (unsaturated) lithium salts was administered to rats in a subacute OECD 422 study can be read across to lithium naphthenate as it is a source of appropriate read across data and, therefore, no classification for specific target organ toxicity for lithium naphthenate is required.  ​ Conclusion for dermal toxicity There are no data for lithium naphthenate. Data from an appropriate read across substance shows dose responsive localized dermal effects at the test site (dorsal surface), consisting of scabbed post dose findings and elevated dermal scores. These findings were most pronounced at 1000 mg/kg/day and were seen most frequently at this dose level. The findings at 300 mg/kg/day were at a lower incidence and with lower dermal scores. Dermal scores and findings at 100 mg/kg/day were comparable to the controls. Based on the lithium content of the test material, the local dermal NOAEL is 0.86 mg lithium/cm2. The systemic dermal NOAEL is 2.62 mg lithium/kg bw/day.   The data have been taken from a structural analogue of lithium naphthenate and are considered appropriate for read across. The result has been recalculated from the structural analogue to lithium naphthenate on the basis of the lithium content. The sample of lithium naphthenate used for hazard testing (taken as representative of the range of potential compositions of lithium naphthenate) contains approximately 2.5% lithium, therefore values listed above have been recalculated for lithium naphthenate. The local dermal NOAEL for lithium naphthenate would be 34.4 mg/cm2. The systemic dermal NOAEL for lithium naphthenate would be 104.8 mg/kg/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): High Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Lithium naphthenate is exclusively produced and used directly in grease form. It has a vapour pressure of less than 0.0025 Pa and a melting point of greater than 131°C, so the potential for the generation of inhalable forms is low. The use of the grease forms will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. In accordance with REACH Regulation, Annex IX, 8.6.2, column 2 as well as Annex XI, 1, the performance of additional repeated dose toxicity studies is not justified due to exposure considerations. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): High ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77716355-63df-4e5f-a777-8a3f2844da9a/documents/a0a5374a-5484-4a7f-9515-22ce7ac677fa_4b012d92-91d6-46a5-b654-7bc3ae786cf5.html,,,,,, "Naphthenic acids, lithium salts",61788-56-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77716355-63df-4e5f-a777-8a3f2844da9a/documents/a0a5374a-5484-4a7f-9515-22ce7ac677fa_4b012d92-91d6-46a5-b654-7bc3ae786cf5.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,104.8 mg/kg bw/day,,rat "Naphthenic acids, lithium salts",61788-56-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77716355-63df-4e5f-a777-8a3f2844da9a/documents/a0a5374a-5484-4a7f-9515-22ce7ac677fa_4b012d92-91d6-46a5-b654-7bc3ae786cf5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Naphthenic acids, lithium salts",61788-56-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/77716355-63df-4e5f-a777-8a3f2844da9a/documents/a0a5374a-5484-4a7f-9515-22ce7ac677fa_4b012d92-91d6-46a5-b654-7bc3ae786cf5.html,Repeated dose toxicity – local effects,dermal,NOAEL,34.4 mg/cm2,adverse effect observed,rat "Naphthenic acids, lithium salts",61788-56-5," This endpoint is waived on the basis that lithium naphthenate is classified as skin corrosive. Therefore, the acute toxicity tests are scientifically unnecessary. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77716355-63df-4e5f-a777-8a3f2844da9a/documents/ad4f4569-b2e9-43ac-b4ff-f0f6c1cff11f_4b012d92-91d6-46a5-b654-7bc3ae786cf5.html,,,,,, "Naphthenic acids, nickel salts",61788-71-4,"No repeated dose toxicity study with naphthenic acids, nickel salts is available, thus the repeated dose toxicity will be addressed with existing data on the individual moieties nickel and naphthenic acids. In relevant and reliable repeated dose toxicity studies for both assessment entities of naphthenic acids, nickel salts, toxicological relevant findings were observed in studies with nickel as well as naphthenic acid. There are several studies that have investigated the repeated toxicity of nickel sulphate via oral and inhalation routes of exposure. Only one set of studies investigating the effects of repeated exposure via the dermal route was identified. The target organ for toxicity caused by repeated exposure to nickel sulphate depends on the route of exposure. For the moiety nickel, chronic lung inflammation including lung fibrosis was observed that results from long-term exposure via inhalation to a concentration of 0.056 mg Ni/m³ or 0.25 mg nickel sulphate hexahydrate/m³. A NOAEC of 0.12 mg/m³ (0.027 mg Ni/m³, MMAD = 2.5 µm) was identified for these effects (Dunnick et al., 1995). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e879712-ca84-4ac8-97c9-013e4019894d/documents/a97a9e11-5a88-42cb-bba3-1c4328c19570_cc8c3b79-d596-4fd2-b9c7-e2898457b398.html,,,,,, "Naphthenic acids, nickel salts",61788-71-4,"The experimentally measured oral LD50 for naphthenic acids, nickel salts is between 300 and 2000 mg/kg bw, resulting in a classification as acute oral toxicity Category 4 (H302) according to regulation (EC) 1272/2008. There is not need for classification for specific target organ toxicity, single exposure (STOT SE). No acute dermal toxicity studies with naphthenic acids, nickel salts are available, thus the acute dermal toxicity will be addressed with existing data on the assessment entities nickel and naphthenic acid. The calculated dermal LD50 for naphthenic acids, nickel salts is >2000 mg/kg bw, thus the substance is not classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e879712-ca84-4ac8-97c9-013e4019894d/documents/af27a708-c716-445e-80fd-88a3dab499f3_cc8c3b79-d596-4fd2-b9c7-e2898457b398.html,,,,,, "Naphthenic acids, nickel salts",61788-71-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e879712-ca84-4ac8-97c9-013e4019894d/documents/af27a708-c716-445e-80fd-88a3dab499f3_cc8c3b79-d596-4fd2-b9c7-e2898457b398.html,,oral,LD50,ca.500 mg/kg bw,adverse effect observed, "Naphthenic acids, potassium salts",66072-08-0,REPEATED DOSE TOXICITY: ORALNOAEL 75 mg/kg/day for male and female Wistar rats ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c342d526-eeff-4ff5-bb51-27229f92ffe4/documents/IUC5-e1859081-e530-4980-b87f-2effcf204dd9_27d80030-c697-4a21-884d-7e0e24dff66b.html,,,,,, "Naphthenic acids, potassium salts",66072-08-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c342d526-eeff-4ff5-bb51-27229f92ffe4/documents/IUC5-e1859081-e530-4980-b87f-2effcf204dd9_27d80030-c697-4a21-884d-7e0e24dff66b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat "Naphthenic acids, potassium salts",66072-08-0,ACUTE TOXICITY: ORAL- LD50 >2000 mg/kg bodyweight to female Wistar strain ratsACUTE TOXICITY: DERMAL- LD50 of naphthenic acids >3160 mg/kg in male and female New Zealand White rabbits- LD50 of naphthenic acids >20 000 mg/kg in male and female New Zealand White rabbits- LD50 of potassium nitrate >5000 mg/kg bw in male and female Sprague-Dawley rats ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c342d526-eeff-4ff5-bb51-27229f92ffe4/documents/IUC5-c0bc37d9-b95d-4714-8c7e-967d4f095228_27d80030-c697-4a21-884d-7e0e24dff66b.html,,,,,, "Naphthenic acids, reaction products with diethylenetriamine",68131-13-5,The repeated dose toxicity of NA-DETA can be reasonably derived by available data on NA-DETA and read-across to naphthenic acids. Liver toxicity together with related systemic effect is expected upon prolonged exposure to NA-DETA. The NOAEL of 6 mg/kg bw for subchronic toxicity of NA-DETA is considered to be valid. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/307c28c3-16ba-4c44-832d-349f5fc03758/documents/IUC5-1db9e0a9-7f53-47da-b195-da9954b43ed5_f9a7ece7-5cda-4186-9e5e-dc44229f5e28.html,,,,,, "Naphthenic acids, reaction products with diethylenetriamine",68131-13-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/307c28c3-16ba-4c44-832d-349f5fc03758/documents/IUC5-1db9e0a9-7f53-47da-b195-da9954b43ed5_f9a7ece7-5cda-4186-9e5e-dc44229f5e28.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,6 mg/kg bw/day,,rat "Naphthenic acids, reaction products with diethylenetriamine",68131-13-5,No classification is warranted for the acute toxicity. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/307c28c3-16ba-4c44-832d-349f5fc03758/documents/IUC5-e662633e-da5f-4aea-9138-0d0211a55215_f9a7ece7-5cda-4186-9e5e-dc44229f5e28.html,,,,,, "Naphthenic acids, reaction products with diethylenetriamine",68131-13-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/307c28c3-16ba-4c44-832d-349f5fc03758/documents/IUC5-e662633e-da5f-4aea-9138-0d0211a55215_f9a7ece7-5cda-4186-9e5e-dc44229f5e28.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, "Naphthenic acids, reaction products with diethylenetriamine",68131-13-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/307c28c3-16ba-4c44-832d-349f5fc03758/documents/IUC5-e662633e-da5f-4aea-9138-0d0211a55215_f9a7ece7-5cda-4186-9e5e-dc44229f5e28.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Naphthenic acids, zinc salts",12001-85-3," There are no data on zinc naphthenate. Data from appropriate read across substances are presented, with data on naphthenic acids, zinc sulphate and zinc monoglycerolate for oral exposure.   Oral Naphthenic acids In a combined repeated dose toxicity and reproduction/developmental toxicity screening study, conducted according to OECD Test Guideline 422 and to GLP, Sprague-Dawley rats (12/sex/group) were orally administered a mixture of naphthenic acids by stomach tube (gavage, in corn oil) at doses of 0, 100, 300 or 900 mg/kg bw/day. Males were dosed for 28 days while females were dosed for a total of 39-53 days. Assessment included clinical and cage-side observations, food consumption and body weight, haematology and clinical chemistry (but no urinalysis), neurobehavioural examination, organ weights, gross pathology and histopathological examination of a wide-range of organs and tissues. A statistically significant increase in liver weight was observed in the mid- (males only) and high-dose groups; kidney weight was significantly elevated in males at the high dose. Reduced growth (not statistically significant), associated with reduced food consumption (statistically significant), was apparent in high-dose animals. Clinical observations and mortality (females only) as well as slight haemoglobin reductions and pale kidneys in males were also observed at 900 mg/kg bw/day. Additional effects on the liver, thyroid and kidney were considered either adaptive, compensatory or not relevant for humans. There were no treatment-related effects at the lowest tested dose and no neurobehavioural effects in any group. On this basis, the NOAEL for general systemic toxicity was established as 100 mg/kg bw/day, while the NOAEL for neurotoxicity was 900 mg/kg bw/day (HPVIS, 2010). [See Effects on fertility and Effects on developmental toxicity sections for further details].   In a limited non-guideline subchronic toxicity study, female Wistar rats (12/group) were gavaged (in water) with a mixture of naphthenic acids (isolated from Athabasca oil sands) at doses of 0, 0.6, 6 or 60 mg/kg bw/day on 5 days/week for 90 days. Relative liver, kidney and brain weights were increased in the high-dose group. Biochemical analysis revealed elevated blood amylase and hypocholesterolaemia in high-dose rats, while hepatic glycogen accumulation was also observed in five animals in this group. These results implicated the liver as a potential target organ. The study NOAEL was set at 6 mg/kg bw/day (Rogers et al., 2002). Another non-guideline investigation involved the repeated oral [presumably gavage] administration of a mixture of naphthenic acids to male mice at 1000 mg/kg bw/day for 30 days. Observed effects included a few cases of CNS depression (without analgesia and no loss of the corneal reflex), haematological changes, weight loss leading eventually to death due to respiratory arrest, gross morphological changes in the liver and stomach, and microscopic changes in a few selected organs (Pennisi and Lynch, 1981). Zinc   Matia (1981a) conducted a study to evaluate the sub chronic (13 week) toxicity of the test material in ICR mice. The study followed was equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents). Mice of both sexes were fed a diet containing test substance at 0, 300, 3,000 and 30,000 ppm for 13 weeks. The clinical signs of the animals, body weight, food, chemical and water intake, food efficiency, haematological, biochemical examination, necropsy and organ weight and histopathological examination were performed. Animals in the 30,000 ppm group showed retarded growth along with low food intake, abnormal values in a few haematological parameters, decreased water intake and significant deviations in biochemical parameters. Histopathological lesions included catarrh at the upper intestine, ulcers at the boundary of fore- and glandular stomach, proliferation of erythropoietic immature cells in the splenic red pulp as well as pancreatic lesions. Under the test conditions, NOEL of the test material in mice was determined to be 3,000 ppm (approximately equivalent to 458 mg/kg/day in male mice or 479 mg/kg/day in female mice).   Matia (1981b) conducted a study to evaluate the subchronic toxicity (13 week) of the test material in Wister rats. The study followed was equivalent or similar to OECD Guideline 408 (Repeated Dose 90-Day Oral Toxicity in Rodents). Rats of both sexes were fed a diet containing the test material at 0, 300, 3,000 and 30,000 ppm for 13 weeks. The clinical signs of the animals, body weight, food, chemical and water intake, food efficiency, haematological, biochemical examination, necropsy and organ weight and histopathological examination were performed. Animals in the 30,000 ppm group showed retarded growth along with low food intake, abnormal values in a few haematological parameters and regressive changes of the pancreatic exocrine gland. There were no remarkable clinical signs in either sex in groups ≤ 3,000 ppm. Under the test conditions, NOEL of the test material in rats was determined to be 3000 ppm (approximately equivalent to 234 mg/kg/day in male rats and 243 mg/kg/day in female rats).   Edwards (1995) studies groups of 20 male and 20 female Sprague-Dawley rats which were fed zinc monoglycerolate at dietary levels of 0, 0.05 or 0.2% (equal to 0, 31.52 or 127.52 mg/kg for males and 0, 35.78 or 145.91 mg/kg bw for females, respectively) for a period of 13 weeks in a study performed according to OECD 408. A similar group was fed 1% (equal to 719 and 805 mg/kg bw/day for males and females, respectively) of zinc monoglycerolate up to day 58 of the study when a deterioration in their clinical condition (poor physical health and reduced food intake) necessitated reducing the dietary level to 0.5% (equal to 632 and 759 mg/kg bw/day for males and females, respectively). However, as no improvement occurred these rats were killed on humane grounds on day 64 of the study. These rats developed hypocupremia manifested as a hypochromic microcytic regenerative type anaemia (low haemoglobin and haematocrit, decreased MCV and MCH, and increased MCHC, red blood cell and reticulocyte count). Enlargement of the mesenteric lymph nodes and slight pitting of the surface of the kidneys were noted. Severe pancreatic degeneration and pathological changes in the spleen, kidneys, incisors, eyes and bones were observed. The testes of all males showed hypoplasia of the seminiferous tubules to a varying degree and in addition the prostate and seminal vesicles showed hypoplasia. In all but one female, the uterus was hypoplastic. All other rats survived to the end of the 13 weeks treatment. At a dietary level of 0.2% increases in plasma ALAT, alkaline phosphatase and creatine kinase were observed in males and in plasma creatine kinase in females. Total plasma cholesterol was reduced in both males and females. The changes were statistically significant but small in absolute terms. No changes in haematological parameters were seen at 0.05 and 0.2%. A dose related reduction in the quantity of abdominal fat was noted in male rats at 0.05 and 0.2%. Enlargement of the mesenteric lymph nodes was apparent in 6 out of 20 rats fed 0.2% and in one male fed 0.05%. Microscopic examination showed a reduction in the number of trabeculae in the metaphysis of the tibia of 5 male and 3 female rats fed 0.2%, 4 males and 1 female had a similar reduction in the metaphysis of the femur. Pancreatic cell necrosis was seen in both sexes at 0.2% and a slight, but statistically not significant increase could be noted at 0.05% (3 males and 1 female). This pancreatic cell necrosis was seen also in 1 control male. A reduction in the number of pigmentated macrophages in the red pulp of the spleen was observed in both sexes at 0.2% and a marginal reduction was also seen in males at 0.05%. In the animals given 0.05 and 0.2% no effects were found on the reproductive organs. Since the pancreatic cell necrosis, being without statistical significance at 0.05%, was also apparent in 1 control male and because the reduction in pigmented macrophages in the spleen was only marginal at 0.05% without any haematological changes, the dose level of 0.05% is considered as a NOAEL. This dose level is equal to 31.52 or 35.78 mg zinc monoglycerolate/kg bw for males and females, respectively, so the NOAEL in this study is 31.52 mg/kg bw (equivalent to 13.26 mg Zn2+/kg bw).   Conclusion for oral toxicity Zinc naphthenate would be expected to dissociate into naphthenic acid anions and zinc cations.   In an OECD Test Guideline 422 combined repeated dose and reproduction/developmental toxicity screening study in rats, conducted to GLP, a mixture of naphthenic acids was administered by gavage for at least 28 days at doses of 0, 100, 300 or 900 mg/kg bw/day. Treatment-related adverse effects were observed in the mid- and high-dose animals (including increased organ weights and decreased food consumption and growth). The NOAEL for systemic toxicity was established as 100 mg/kg bw/day (HPVIS, 2010).   The repeated dose toxicity of water soluble zinc sulphate and zinc monoglycerolate has been examined in a total of 3 subchronic oral feeding key studies. The lowest NOAEL was determined to be 31.5 mg/kg bw/day of zinc monoglycerolate which equals a total zinc exposure of approximate 13 mg/kg bw/day (Edwards, 1995).   The sample of zinc naphthenate used for hazard testing (taken as representative of the range of potential compositions of zinc naphthenate) contains approximately 14.3% zinc, therefore the NOAEL value has been recalculated for zinc naphthenate. The oral NOAEL for zinc naphthenate would be 89.7 mg/kg/day.   Inhalation A short-term toxicity study on zinc naphthenate via the inhalation route does not need to be conducted because reliable sub-chronic (90 days) data are available for an appropriate species, dosage, solvent and route of administration. Repeated dose oral toxicity data have been read across from naphthenic acids and zinc salts. Furthermore, this substance is exclusively produced and used directly in grease form. The main constituent has a vapour pressure of 0.026 Pa, so the potential for the generation of inhalable forms is low. Also, the use of the grease forms will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur. Dermal A short-term toxicity study on zinc naphthenate via the dermal route does not need to be conducted because reliable sub-chronic (90 days) data are available for an appropriate species, dosage, solvent and route of administration. Repeated dose oral toxicity data have been read across from naphthenic acids and zinc salts. Furthermore, zinc naphthenate is exclusively manufactured in situ in base oil and not in isolated form, so the potential for dermal contact with the isolated substance is low. Also, the use of the grease forms is expected to significantly lower the rate of adsorption through the skin, so exposure to humans via the dermal route will be unlikely to occur. The use of zinc naphthenate as grease thickeners under industrial exposure considerations precludes the relevance of the dermal route for repeated dose toxicity testing. On the assumption that the test substances will be prepared specifically for purposes for registration rather than being representative of material ‘placed on the market’, the conduct of a subacute toxicity study by the dermal route of exposure is not considered relevant for the substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/232a00b7-8bb0-4ee5-84d3-ffe239d58829/documents/805d6ae4-9f83-45bd-9795-5c78cadcf504_ecbf4590-4e62-4a9b-97cf-25a94950f369.html,,,,,, "Naphthenic acids, zinc salts",12001-85-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/232a00b7-8bb0-4ee5-84d3-ffe239d58829/documents/805d6ae4-9f83-45bd-9795-5c78cadcf504_ecbf4590-4e62-4a9b-97cf-25a94950f369.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,89.7 mg/kg bw/day,,rat "Naphthenic acids, zinc salts",12001-85-3," The acute oral toxicity of naphthenic acids, zinc salts, neutral, was evaluated in a GLP-compliant study following OECD guideline 423. 6 female rats were exposed to a single dose by oral gavage and no effects were observed. Therefore, the oral LD50 value in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. Based on these results, the substance does not meet the criteria for classification under EU CLP. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/232a00b7-8bb0-4ee5-84d3-ffe239d58829/documents/d42e0953-ca77-4401-8f28-8d9991a7b2f5_ecbf4590-4e62-4a9b-97cf-25a94950f369.html,,,,,, "Naphthenic acids, zinc salts, basic",84418-50-8," No repeated dose toxicity study with naphthenic acids, zinc salts, basic is available. Thus, read-across to naphthenic acids, zinc salts is applied. In a relevant and reliable 2 -generation reproductive toxicity study, rats were exposed to 500, 1000 and 5000 ppm naphthenic acids, zinc salts via the diet. Parental animals of the high dose group showed body weight depression while food consumption was comparable to those of control animals. Thus, the NOAEL for systemic toxicity was set at 1000 ppm (equal to 50 mg/kg bw/day) based on effects on body weight. There were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. Hence, no classification for naphthenic acids, zinc salts, basic as STOT RE via the oral route is required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85caa06d-35b9-4216-8d8c-ac37a04bdbab/documents/acbc9fdf-9c1f-4f9b-9467-1346f32c9d3a_7360390c-a34f-45ed-9b2c-c04ca7bfee8b.html,,,,,, "Naphthenic acids, zinc salts, basic",84418-50-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85caa06d-35b9-4216-8d8c-ac37a04bdbab/documents/acbc9fdf-9c1f-4f9b-9467-1346f32c9d3a_7360390c-a34f-45ed-9b2c-c04ca7bfee8b.html,Chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Naphthenic acids, zinc salts, basic",84418-50-8," A substance specific key study for acute oral toxicity with naphthenic acids, zinc salts, basic is available indicating no signs of acute oral toxicity with a LD50 for female rats greater than 2000 mg/kg bw. In a supporting study for acute oral toxicity, naphthenic acids, zinc salts did not show signs of acute toxicity as well, with a LD50 for male and female rats greater than 5000 mg/kg bw. A key study for acute inhalation toxicity with naphthenic acids, zinc salts is available, indicating a LC50 greater than 420 mg/m3 (analytical concentration; test was conducted at the maximum attainable concentration). A key study for acute dermal toxicity with naphthenic acids, zinc salts is available indicating an LD50 greater than 2000 mg/kg bw. Overall, Naphthenic acids, zinc salts, basic is not expected to show acute toxic effects via oral, inhalation and dermal route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85caa06d-35b9-4216-8d8c-ac37a04bdbab/documents/7fa9b7cc-25c6-40fc-ac8c-80aba035f4c9_7360390c-a34f-45ed-9b2c-c04ca7bfee8b.html,,,,,, "Naphthenic acids, zinc salts, basic",84418-50-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85caa06d-35b9-4216-8d8c-ac37a04bdbab/documents/7fa9b7cc-25c6-40fc-ac8c-80aba035f4c9_7360390c-a34f-45ed-9b2c-c04ca7bfee8b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphthenic acids, zinc salts, basic",84418-50-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85caa06d-35b9-4216-8d8c-ac37a04bdbab/documents/7fa9b7cc-25c6-40fc-ac8c-80aba035f4c9_7360390c-a34f-45ed-9b2c-c04ca7bfee8b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Naphthenic acids, zinc salts, basic",84418-50-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85caa06d-35b9-4216-8d8c-ac37a04bdbab/documents/7fa9b7cc-25c6-40fc-ac8c-80aba035f4c9_7360390c-a34f-45ed-9b2c-c04ca7bfee8b.html,,inhalation,LC50,420 mg/m3,no adverse effect observed, "N-benzoyl-5'-O-(p,p'-dimethoxytrityl)-2'-deoxycytidine",67219-55-0," In an acute oral toxicity study in rats conducted according to OECD 423, the target substance N4-Benzoyl-5'-O-(4,4'-dimethoxytrityl)-2'-deoxycytidine showed no mortality at the limit dose of 2000 mg/kg bw. Hence, the LD50 value was considered to exceed 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ae98bea-5a04-4faa-bc41-e150ac42dd55/documents/7863d43e-b620-4ba0-9d28-8392b7a0b49c_ee5886d5-58fa-441c-aac2-a591668cfc93.html,,,,,, N-benzoyl-5'-O-[bis(4-methoxyphenyl)phenylmethyl]-2'-deoxyadenosine,64325-78-6," In an acute oral toxicity study in rats conducted according to OECD 423, the target substance N-Benzoyl-5’-O-[bis(4-methoxyphenyl)phenylmethyl]-2’-deoxyadenosine showed no mortality at the limit dose of 2000 mg/kg bw. Hence, the LD50 value is considered to exceed 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d6773bf-0d01-4c69-9d20-9a62622c385f/documents/6c46e414-0aa1-42f7-bf70-56d9f85264eb_3d0e5a3b-acd0-4fab-a312-859292186546.html,,,,,, N-benzylethylenediamine,4152-09-4,"OECD 423, GLP, Klimisch reliability score 1, rat: LD50 > 300 < 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83f72ce7-47f6-4670-b14b-c4f11c7f0869/documents/25042460-33c4-4dc3-9652-551e59700e1a_7554fb8f-1c26-4dea-ad99-6a24515ae663.html,,,,,, N-benzylethylenediamine,4152-09-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83f72ce7-47f6-4670-b14b-c4f11c7f0869/documents/25042460-33c4-4dc3-9652-551e59700e1a_7554fb8f-1c26-4dea-ad99-6a24515ae663.html,,oral,LD50,"< 2,000 mg/kg bw",adverse effect observed, N-benzyl-N-C16-18 (even numbered)-alkyl-N-methyl-C16-18 (even numbered)-alkyl-1-aminium chloride,1228186-15-9,"The potential toxicity of BDHTMAC (see Toxicological information section for the justification of read across) following repeated administration was assessed using:- two subacute (28-day) oral (gavage) studies performed in rats according to OECD guideline 407 and Good Laboratory Practices with the test substance, BDHTMAC (Queudot, 2010a) or with dimethyldioctadecylammonium chloride (DODMAC), the major active component of the ditallowdimethylammonium chloride (DHTDMAC)(Hoechst, 1990).- two subchronic (90-day) feeding studies performed with the analogue substance DHTDMAC, in Beagle-dogs or in rats according to a method similar to OECD guideline 409 and 408, respectively (Lindberg, 1971).The results of the four studies were coherent and indicated that the substance was of moderate toxicity by repeated gavage administration. Based on some limitations of the studies perfomed with the analogue substances, the valid 28-day subacute toxicity study in rats performed with the test substance (Queudot, 2010a) is taken for risk characterisation. According to the results of this study, the NOAEL with regard to systemic oral toxicity was established at 100 mg/kg body weight per day. In an earlier study predating official test guidelines and Good Laboratories Practices, rabbits received technical grade of DODMAC (75% active in isopropanol/water) via the dermal route of exposure. Twenty applications (5 per week for 4 consecutive weeks) of 2 mL of 0, 0.2 and 2% aqueous test substance solutions (corresponding to about 0, 4 and 40 mg/kg body weight per day) induced mild local dermal effects but no clinical or morphological signs of substance related systemic toxicity. Based on an analogue approach, The NOAEL for the dermal systemic effects of the substance was considered to be greater than 40 mg/kg body weight per day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af1ccf69-178b-45d2-a555-37930c11a5f0/documents/IUC5-2841a175-8af3-4105-bf2d-472f4d31e829_37e254e6-f861-47bb-9768-392bb8decb39.html,,,,,, N-benzyl-N-C16-18 (even numbered)-alkyl-N-methyl-C16-18 (even numbered)-alkyl-1-aminium chloride,1228186-15-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af1ccf69-178b-45d2-a555-37930c11a5f0/documents/IUC5-2841a175-8af3-4105-bf2d-472f4d31e829_37e254e6-f861-47bb-9768-392bb8decb39.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat N-benzyl-N-C16-18 (even numbered)-alkyl-N-methyl-C16-18 (even numbered)-alkyl-1-aminium chloride,1228186-15-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af1ccf69-178b-45d2-a555-37930c11a5f0/documents/IUC5-2841a175-8af3-4105-bf2d-472f4d31e829_37e254e6-f861-47bb-9768-392bb8decb39.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,40 mg/kg bw/day,,rabbit N-benzyl-N-C16-18 (even numbered)-alkyl-N-methyl-C16-18 (even numbered)-alkyl-1-aminium chloride,1228186-15-9,"The acute oral toxicity of the substance was assessed using:-2 acute oral toxicity limit tests performed in rats according to OECD 423 and 401 guidelines and Good Laboratory Practices (Longobardi, 2002a and Daamen, 1991a).The substance is of low acute toxicity following oral exposure:The oral LD0 was found to be greater than 2000 mg/kg bw in both sexes.The acute dermal toxicity of the substance was assessed using:- An acute dermal toxicity test performed in rats according to OECD 402 guideline and Good Laboratory Practices (Queudot, 2010).The substance is of low acute toxicity following dermal exposure:The oral LD0 was found to be greater than 2000 mg/kg bw.No information regarding the acute inhalation toxicity of the substance were available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af1ccf69-178b-45d2-a555-37930c11a5f0/documents/IUC5-2e931d4e-6529-411d-b6e0-ab4083fbf954_37e254e6-f861-47bb-9768-392bb8decb39.html,,,,,, N-benzyl-N-C16-18 (even numbered)-alkyl-N-methyl-C16-18 (even numbered)-alkyl-1-aminium chloride,1228186-15-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af1ccf69-178b-45d2-a555-37930c11a5f0/documents/IUC5-2e931d4e-6529-411d-b6e0-ab4083fbf954_37e254e6-f861-47bb-9768-392bb8decb39.html,,oral,LD50,"2,000 mg/kg bw",, N-benzyl-N-C16-18 (even numbered)-alkyl-N-methyl-C16-18 (even numbered)-alkyl-1-aminium chloride,1228186-15-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af1ccf69-178b-45d2-a555-37930c11a5f0/documents/IUC5-2e931d4e-6529-411d-b6e0-ab4083fbf954_37e254e6-f861-47bb-9768-392bb8decb39.html,,dermal,LD50,"2,000 mg/kg bw",, N-benzyl-N-ethylaniline,92-59-1," In a prediction done by SSS (2017) using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor, the acute oral toxicity was estimated for N-benzyl-N-ethylaniline. The LD50 was estimated to be 1042.3 mg/kg bw when rats were orally exposed with N-benzyl-N-ethylaniline.  ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c31e3298-2b27-4941-8a61-d830c540927a/documents/7d1d94d1-c27d-41e4-9a21-ad8bda895cef_e1097d1e-3506-403e-9f4f-7926ee5bfe47.html,,,,,, N-benzyl-N-ethylaniline,92-59-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c31e3298-2b27-4941-8a61-d830c540927a/documents/7d1d94d1-c27d-41e4-9a21-ad8bda895cef_e1097d1e-3506-403e-9f4f-7926ee5bfe47.html,,oral,LD50,"1,042.3 mg/kg bw",no adverse effect observed, N-butyl phenyl ether,1126-79-0, OECD 422 combined repeated dose/reproductive screening study in rats (oral gavage) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6867624b-3b70-477b-bb78-e640b07c1fdf/documents/fde1c640-ca48-44c6-8cf8-27d1cf772c89_b5ab7f84-5bc1-4c85-889c-2caec4b92767.html,,,,,, N-butyl phenyl ether,1126-79-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6867624b-3b70-477b-bb78-e640b07c1fdf/documents/fde1c640-ca48-44c6-8cf8-27d1cf772c89_b5ab7f84-5bc1-4c85-889c-2caec4b92767.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,30 mg/kg bw/day,,rat N-butyl phenyl ether,1126-79-0,"For Butyl Phenyl Ether there is reliability 1, OECD guideline oral toxicity study in female rats, and an older non-guideline acute oral toxicity study in mice. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6867624b-3b70-477b-bb78-e640b07c1fdf/documents/IUC5-b6938375-7a6e-4f7a-975a-d927bd0f7d1c_b5ab7f84-5bc1-4c85-889c-2caec4b92767.html,,,,,, "N-butyl-2,2,6,6-tetramethylpiperidin-4-amine",36177-92-1,"The available data indicate a potential for acute toxicity. The acute oral toxicity (LD50) in rats was determined to be larger than 300 mg/kg and smaller than 2000 mg/kg bw, a cut-off of 500 mg/kg bw was derived (Evonik, 2003, OECD 423). The acute dermal lethal dose (LD50) of the test item N-Butyl-TAD was found to be lower than 2000 mg/kg bw in male and female CRL:(WI) rats in a limit test. Due to the corrosive potential of the test item, a full test was not performed for animal welfare reasons. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c48786ae-69d2-472e-a0bd-a9de3529b8b0/documents/IUC5-c3e57b80-c12c-476a-aa2f-41f8ef112148_9d93480c-dfba-4c76-b7f8-793ac1e28c23.html,,,,,, "N-butyl-2,2,6,6-tetramethylpiperidin-4-amine",36177-92-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c48786ae-69d2-472e-a0bd-a9de3529b8b0/documents/IUC5-c3e57b80-c12c-476a-aa2f-41f8ef112148_9d93480c-dfba-4c76-b7f8-793ac1e28c23.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "N-butyl-2,2,6,6-tetramethylpiperidin-4-amine",36177-92-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c48786ae-69d2-472e-a0bd-a9de3529b8b0/documents/IUC5-c3e57b80-c12c-476a-aa2f-41f8ef112148_9d93480c-dfba-4c76-b7f8-793ac1e28c23.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "N-butyl-2,2,6,6-tetramethylpiperidin-4-amine, oligomeric reaction products with N,N'-bis(3-aminopropyl)ethylenediamine and 2,4,6-trichloro-1,3,5-triazine",120498-03-5,"The repeated toxicity was investigated with a Sub-chronic (13 week) oral toxicity study in rats following the FDA guideline for testing food addtives (Toxicological Principles for the Safety Assessment of Direct Food Additives and Colour additives used in food; US Food and Drug Administration Bureau of Foods, 1982). The study was performed in GLP.20 females and 20 males per dose group were treated at the following doses: 5, 13 and 24 mg/kg b.w. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e78b209-6f7d-434b-b1e6-fcc245b091b7/documents/IUC5-a83f2991-1c55-4a79-8cea-d8e29afca8b3_e56af14e-01c1-4a65-bc18-5b5d55ea07d2.html,,,,,, "N-butyl-2,2,6,6-tetramethylpiperidin-4-amine, oligomeric reaction products with N,N'-bis(3-aminopropyl)ethylenediamine and 2,4,6-trichloro-1,3,5-triazine",120498-03-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e78b209-6f7d-434b-b1e6-fcc245b091b7/documents/IUC5-a83f2991-1c55-4a79-8cea-d8e29afca8b3_e56af14e-01c1-4a65-bc18-5b5d55ea07d2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,24 mg/kg bw/day,,rat "N-butyl-2,2,6,6-tetramethylpiperidin-4-amine, oligomeric reaction products with N,N'-bis(3-aminopropyl)ethylenediamine and 2,4,6-trichloro-1,3,5-triazine",120498-03-5,"The oral toxicity study was performed following EPA: Toxic substances guideline, HG Acute oral. October 1984.The study was performed under GLP conditions. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e78b209-6f7d-434b-b1e6-fcc245b091b7/documents/IUC5-2751025e-abad-4e7f-9563-8ad871b5bcc8_e56af14e-01c1-4a65-bc18-5b5d55ea07d2.html,,,,,, "N-butyl-2,2,6,6-tetramethylpiperidin-4-amine, oligomeric reaction products with N,N'-bis(3-aminopropyl)ethylenediamine and 2,4,6-trichloro-1,3,5-triazine",120498-03-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e78b209-6f7d-434b-b1e6-fcc245b091b7/documents/IUC5-2751025e-abad-4e7f-9563-8ad871b5bcc8_e56af14e-01c1-4a65-bc18-5b5d55ea07d2.html,,oral,LD50,"3,200 mg/kg bw",, N-butylbenzenesulphonamide,3622-84-2,"A subacute 28 -day oral toxicity with BBSA was conducted by oral daily gavage in Wistar rats at dose levels of 0, 50, 150 and 1000 mg/kg bw. The high dose of 1000 mg/kg/day resulted in the death or moribund state of all rats, with liver enlargement and hepatocyte hypertrophy, liver necrosis, hyaline droplets formation in the renal papillary collecting ducts, adrenal gland enlargement with fatty change or cortical hypertrophy and reduced size and/or atrophy of the thymus, spleen and male reproductive organs. At 150 mg/kg/day, post-mortem findings were confined to liver enlargement and hepatocyte hypertrophy, thymic atrophy and lymphocytolysis as relevant changes. At 50 mg/kg/day, there were no relevant changes, therefore a NOAEL of 50 mg/kg/day was established.   A dietary 14-day dose range finding study was conducted in Wistar rats to prepare for the 90-day toxicity study at dietary concentrations of 625, 1563, 5875 and 12500 ppm, corresponding with mean test item intake values of 52.4, 124.2, 392.7 and 543.7 mg/kg bw/day, respectively. The 5875 and 12500 ppm dose levels were concluded to be above the Maximum Tolerable Dose for the sub-chronic repeated dose toxicity study.   A key 90-day dietary study in Wistar rats was conducted at 0, 700, 1750 and 3750 ppm dose levels, corresponding with 51.9, 132.5 and 265.4 mg/kg bw/day respectively. Effects observed included decreased body weight (gain) in the animals of the High and Mid dose groups and food consumption which was significantly reduced by the test item administration in the High dose group; in the Mid dose group a transient effect in the first one or two weeks was seen. Food efficiency was statistically significantly lower at 1750 and 3750 ppm both in males and females. There were signs of slight anaemia in the High dose groups (up to 10% lower RBC, HCT and haemoglobin concentration) with a similar trend in the Mid dose. Compared to control, test item related increase in kidney weights (absolute and body related) were detected for High and Mid dose males, associated with increased kidney size and histopathology change. Increased adrenal weights were also noted for High dose males, but without any histopathology change. Test item related dark red foci on liver lobes were noted in some High and Mid dose animals at necropsy, but no Low dose animals were affected. The change corresponded with histopathology observations of necrosis (mild to moderate at Mid dose males and High dose female; marked in High dose male). Test item related alpha 2-microglobulin nephropathy was observed in male rats only. The observed microscopic changes were confirmed by special immunohistochemistry staining and not considered relevant for humans. Test item-related focal/multifocal hepatocellular necrosis was noted as adverse change but at low incidence in the liver of High and Mid dose males as well as in High dose females. No test item related effect was observed in the adrenals and thymus of male and female animals in any dose groups. Finally, there were no treatment-related effects at any dose levels on sperm morphology or enumeration. In conclusion. The NOAEL was 700 ppm dietary concentration (51.9 mg/kg bw/day).   A key repeated dose 28 day dermal toxicity study was conducted in Wistar Rats at dose levels of 0, 250, 500 and 1000 mg/kg bw (semi-occlusive dosing; no vehicle). On the basis of the results obtained in the present study, no mortality was observed in both sex of treated as well as control group of animals during entire experiment period. Although few changes occurred in hematology and clinical biochemistry parameters, those changes were not related to test substance and could be considered as individual animal normal biological variance. There was no test substance related macroscopic and microscopic findings observed. In the light of above observations, the NOEL of N-n- Butylbenzenesulphonamide for Wistar rats could be considered as >1000 mg/kg bw under the experimental conditions.   Inhalation testing was waived.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7909b8f3-3fcd-42d7-85d4-592e165907d7/documents/693a0b6f-7618-41da-ae4d-177cc1b23fe7_b6bbe8c8-36d7-42bd-b7b1-5ef333af4f2f.html,,,,,, N-butylbenzenesulphonamide,3622-84-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7909b8f3-3fcd-42d7-85d4-592e165907d7/documents/693a0b6f-7618-41da-ae4d-177cc1b23fe7_b6bbe8c8-36d7-42bd-b7b1-5ef333af4f2f.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat N-butylbenzenesulphonamide,3622-84-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7909b8f3-3fcd-42d7-85d4-592e165907d7/documents/693a0b6f-7618-41da-ae4d-177cc1b23fe7_b6bbe8c8-36d7-42bd-b7b1-5ef333af4f2f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,51.9 mg/kg bw/day,,rat N-butylbenzenesulphonamide,3622-84-2,LD50 values for acute toxicity is higher than 2000 mg/kg bw in both the oral and dermal study and higher than 4066 mg/m³ air in the inhalation study. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7909b8f3-3fcd-42d7-85d4-592e165907d7/documents/c432d668-b2d2-46a8-bee1-efcb84f49eb2_b6bbe8c8-36d7-42bd-b7b1-5ef333af4f2f.html,,,,,, N-butylbenzenesulphonamide,3622-84-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7909b8f3-3fcd-42d7-85d4-592e165907d7/documents/c432d668-b2d2-46a8-bee1-efcb84f49eb2_b6bbe8c8-36d7-42bd-b7b1-5ef333af4f2f.html,,oral,LD50,"2,070 mg/kg bw",adverse effect observed, N-butylbenzenesulphonamide,3622-84-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7909b8f3-3fcd-42d7-85d4-592e165907d7/documents/c432d668-b2d2-46a8-bee1-efcb84f49eb2_b6bbe8c8-36d7-42bd-b7b1-5ef333af4f2f.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, N-butylbenzenesulphonamide,3622-84-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7909b8f3-3fcd-42d7-85d4-592e165907d7/documents/c432d668-b2d2-46a8-bee1-efcb84f49eb2_b6bbe8c8-36d7-42bd-b7b1-5ef333af4f2f.html,,inhalation,LC50,"4,066 mg/m3",no adverse effect observed, N-butyl-N-((triethoxysilyl)methyl)butan-1-amine,35501-23-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.6, of Regulation (EC) No 1907/2006. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aff5b4f-a459-416d-bac7-5b02ad359a32/documents/IUC5-4d779162-0f6b-43fe-9fac-73c7e7bf6faf_a9d619d4-36cb-487c-8bf0-da18cca36b27.html,,,,,, N-butylphosphorothioic triamide,94317-64-3,"Oral (according to OECD 408), subchronic, rat: NOAEL (systemic), males/females = 74/88 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41af1b78-fd58-4402-a9a5-c6f482215f75/documents/IUC5-d0bb0841-cc7e-4fcb-b1bc-69d7584de57b_4d6d92b1-115d-472f-926e-d1a42b78ab4d.html,,,,,, N-butylphosphorothioic triamide,94317-64-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41af1b78-fd58-4402-a9a5-c6f482215f75/documents/IUC5-d0bb0841-cc7e-4fcb-b1bc-69d7584de57b_4d6d92b1-115d-472f-926e-d1a42b78ab4d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,74 mg/kg bw/day,,rat N-butylphosphorothioic triamide,94317-64-3,"Acute toxicity:Oral (OECD 401), rat: LD50 2823 mg/kg bw Dermal (OECD 402), rabbit: LD50 >2000 mg/kg bwInhalation (OECD 403), rat, 4 hour exposure: LD50 >2100 mg/m³ ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41af1b78-fd58-4402-a9a5-c6f482215f75/documents/IUC5-d64716db-a14a-44e9-8f53-a6375ae6962d_4d6d92b1-115d-472f-926e-d1a42b78ab4d.html,,,,,, N-butylphosphorothioic triamide,94317-64-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41af1b78-fd58-4402-a9a5-c6f482215f75/documents/IUC5-d64716db-a14a-44e9-8f53-a6375ae6962d_4d6d92b1-115d-472f-926e-d1a42b78ab4d.html,,oral,LD50,"2,823 mg/kg bw",no adverse effect observed, N-butylphosphorothioic triamide,94317-64-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41af1b78-fd58-4402-a9a5-c6f482215f75/documents/IUC5-d64716db-a14a-44e9-8f53-a6375ae6962d_4d6d92b1-115d-472f-926e-d1a42b78ab4d.html,,dermal,,"2,000 mg/kg bw",no adverse effect observed, N-butylphosphorothioic triamide,94317-64-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41af1b78-fd58-4402-a9a5-c6f482215f75/documents/IUC5-d64716db-a14a-44e9-8f53-a6375ae6962d_4d6d92b1-115d-472f-926e-d1a42b78ab4d.html,,inhalation,,"2,100 mg/m3",no adverse effect observed, N-butyltin trichloride,1118-46-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e5e320b-7f5f-47ad-a66b-ab88ae798f3a/documents/d61cdcc2-ad24-4034-94f8-d2936e0ec847_d09301a7-dc2e-4d8f-a8d6-5e51242e64a9.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,16.18 mg/m3,,rat N-butyltin trichloride,1118-46-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e5e320b-7f5f-47ad-a66b-ab88ae798f3a/documents/d61cdcc2-ad24-4034-94f8-d2936e0ec847_d09301a7-dc2e-4d8f-a8d6-5e51242e64a9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,96 mg/kg bw/day,,rat N-butyltin trichloride,1118-46-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e5e320b-7f5f-47ad-a66b-ab88ae798f3a/documents/d61cdcc2-ad24-4034-94f8-d2936e0ec847_d09301a7-dc2e-4d8f-a8d6-5e51242e64a9.html,Repeated dose toxicity – local effects,inhalation,LOAEC,3 mg/m3,adverse effect observed,rat N-butyltin trichloride,1118-46-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e5e320b-7f5f-47ad-a66b-ab88ae798f3a/documents/5e407af8-14b2-4201-b51b-a7eb5dd466c5_d09301a7-dc2e-4d8f-a8d6-5e51242e64a9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, N-carbamoylmethyliminodi(acetic acid),26239-55-4, The LD50 of the test item is between 300 and 2000 mg/kg body weight by oral route in the rat (reference 7.2.1 -1). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a77f9e1-d0c8-4db3-b4d4-3d4c0fe9c8c2/documents/752b2f17-c31c-432c-a7df-117c85ea2d04_6698e422-290d-42b3-99bd-e5594fabf290.html,,,,,, N-carbamoylmethyliminodi(acetic acid),26239-55-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a77f9e1-d0c8-4db3-b4d4-3d4c0fe9c8c2/documents/752b2f17-c31c-432c-a7df-117c85ea2d04_6698e422-290d-42b3-99bd-e5594fabf290.html,,oral,LD50,300 mg/kg bw,adverse effect observed, N-chlorosuccinimide,128-09-6, The substance is hazardous with oral LD50-values reported in the range of 1000 to 2700 mg/kg bw. After intravenous application the LD50 is between 200 and 400 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ce63161-d791-4274-b371-bea70833e83a/documents/IUC5-afe2c704-8cab-4df8-956c-eb5bfb921dc3_f9f81037-9abd-4d7e-abf5-0688fe6dede8.html,,,,,, N-chlorosuccinimide,128-09-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ce63161-d791-4274-b371-bea70833e83a/documents/IUC5-afe2c704-8cab-4df8-956c-eb5bfb921dc3_f9f81037-9abd-4d7e-abf5-0688fe6dede8.html,,oral,LD50,"1,212 mg/kg bw",adverse effect observed, N-cyclohexylbenzothiazole-2-sulfenamide,95-33-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): The available study is GLP and assigned high quality (Klimisch 1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The endpoint is concluded based on a subacute toxicity study on CBS conducted to GLP and test guideline (equiv. OECD 422). It has been evaluated to be of good quality (Klimisch score = 2). Further supporting evidence is available from a supporting study of good quality (Klimisch score 2) conducted to sound scientific principle. A recent scientific evaluation of the Sulfenamides category data set was undertaken to identify testing requirements to ensure suitable coverage of required endpoints for all member substances. This category member has been identified as having a data gap for sub-chronic repeated dose toxicity testing (OECD 408), required in accordance with Annex IX of Regulation (EC) No 1907/2006. A testing proposal has been submitted for an OECD 408 on CBS via the oral route (January 2023). The results of this study will be used to complete the dossier for CBS, as well as form part of the overall category data set as a source study for read across. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e07eb44-617c-46ad-bce3-2fae731fbfb2/documents/91ba1477-7c3b-4dd8-9296-dceaa04655d4_0eba8a26-ad07-4be1-a12a-0a8353a91f95.html,,,,,, N-cyclohexylbenzothiazole-2-sulfenamide,95-33-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e07eb44-617c-46ad-bce3-2fae731fbfb2/documents/91ba1477-7c3b-4dd8-9296-dceaa04655d4_0eba8a26-ad07-4be1-a12a-0a8353a91f95.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat N-cyclohexylbenzothiazole-2-sulfenamide,95-33-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e07eb44-617c-46ad-bce3-2fae731fbfb2/documents/91ba1477-7c3b-4dd8-9296-dceaa04655d4_0eba8a26-ad07-4be1-a12a-0a8353a91f95.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rabbit N-cyclohexylbenzothiazole-2-sulfenamide,95-33-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Several acute oral toxicity studies in rats and mice demonstrate a LD50 > 2000 mg/kg bw. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Limited documented study report, with restrictions, but sufficient for risk assessment. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e07eb44-617c-46ad-bce3-2fae731fbfb2/documents/c25c7f1a-5fc5-4d12-89db-f57ab348949c_0eba8a26-ad07-4be1-a12a-0a8353a91f95.html,,,,,, N-cyclohexylbenzothiazole-2-sulfenamide,95-33-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e07eb44-617c-46ad-bce3-2fae731fbfb2/documents/c25c7f1a-5fc5-4d12-89db-f57ab348949c_0eba8a26-ad07-4be1-a12a-0a8353a91f95.html,,oral,discriminating dose,"5,300 mg/kg bw",adverse effect observed, N-cyclohexylbenzothiazole-2-sulfenamide,95-33-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e07eb44-617c-46ad-bce3-2fae731fbfb2/documents/c25c7f1a-5fc5-4d12-89db-f57ab348949c_0eba8a26-ad07-4be1-a12a-0a8353a91f95.html,,dermal,discriminating dose,"7,940 mg/kg bw",no adverse effect observed, N-cyclohexylcyclohexanamine 2-[1-[[[(1R)-1-[3-[(1E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanyl]methyl]cyclopropyl]acetate,577953-88-9," A Repeated Dose 28-day Oral Toxicity Study in Rodents equivalent to EU Method B.7, conducted on dicyclohexylamine was taken as the key study, resulting in NOAEL of 20 mg/kg body weight/day for males and females. When the point of departure was adjusted to account for the molecular weights of the molar equivalents in the registered substance, the adjusted NOAEL was 84.6 mg/kg/day for Montelukast.DCHA. In addition, a 14 week oral toxicity Study in rodents, equivalent to EU Method B.26 was conducted on sodium Montelukast, which resulted in a NOAEL of 50 mg/kg/day for males and females. When the point of departure was adjusted to account for the molecular weights of the molar equivalents in the registered substance, the adjusted NOAEL was 65.5 mg/kg/day for Montelukast.DCHA. Selection of the point of departure also took into account the appropriate adjustment factors to allow the derivation of the most conservative DNEL value. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82e19422-0546-44d0-855c-b10bb9260527/documents/4ea72590-5fed-423f-8e86-a53318784ddd_4b692317-448e-4c3a-b690-c0fa394cfbf6.html,,,,,, N-cyclohexylcyclohexanamine 2-[1-[[[(1R)-1-[3-[(1E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanyl]methyl]cyclopropyl]acetate,577953-88-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82e19422-0546-44d0-855c-b10bb9260527/documents/4ea72590-5fed-423f-8e86-a53318784ddd_4b692317-448e-4c3a-b690-c0fa394cfbf6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,84.6 mg/kg bw/day,,rat N-cyclohexylcyclohexanamine 2-[1-[[[(1R)-1-[3-[(1E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanyl]methyl]cyclopropyl]acetate,577953-88-9," Two studies, acute oral and dermal were performed on rats with results predicting the LD50 >2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82e19422-0546-44d0-855c-b10bb9260527/documents/IUC5-b7149248-5e02-495c-bc25-631d848b796f_4b692317-448e-4c3a-b690-c0fa394cfbf6.html,,,,,, N-cyclohexylcyclohexanamine 2-[1-[[[(1R)-1-[3-[(1E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanyl]methyl]cyclopropyl]acetate,577953-88-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82e19422-0546-44d0-855c-b10bb9260527/documents/IUC5-b7149248-5e02-495c-bc25-631d848b796f_4b692317-448e-4c3a-b690-c0fa394cfbf6.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, N-cyclohexylcyclohexanamine 2-[1-[[[(1R)-1-[3-[(1E)-2-(7-chloroquinolin-2-yl)ethenyl]phenyl]-3-[2-(2-hydroxypropan-2-yl)phenyl]propyl]sulfanyl]methyl]cyclopropyl]acetate,577953-88-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82e19422-0546-44d0-855c-b10bb9260527/documents/IUC5-b7149248-5e02-495c-bc25-631d848b796f_4b692317-448e-4c3a-b690-c0fa394cfbf6.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Neodecanoic acid,26896-20-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Reliability and consistency within this study and the preliminary 14-day oral toxicity study for dose level selection (i.e. quality of testing methods, size and statistical power of study design, biological plausibility, dose-response relationships and statistical testing). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b5b17b2-0ad1-4b94-917e-3cf3ce781076/documents/IUC5-823742b8-f3b4-4df8-a688-c45e8a283fde_6e19dce7-7db7-4189-b3a1-274f6846e1dc.html,,,,,, Neodecanoic acid,26896-20-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b5b17b2-0ad1-4b94-917e-3cf3ce781076/documents/IUC5-823742b8-f3b4-4df8-a688-c45e8a283fde_6e19dce7-7db7-4189-b3a1-274f6846e1dc.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,, Neodecanoic acid,26896-20-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b5b17b2-0ad1-4b94-917e-3cf3ce781076/documents/IUC5-823742b8-f3b4-4df8-a688-c45e8a283fde_6e19dce7-7db7-4189-b3a1-274f6846e1dc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,700 mg/kg bw/day,,rat Neodecanoic acid,26896-20-8,Neodecanoic acid has an oral LD50 between 300 and 2000 mg/kg bw in female Han:WIST rats. The LD50 cut-off value is 1000 mg/kg bw. This results in a classification/labelling according to Regulation (EC) No 1272/2008 (CLP) as Category 4 (H302). The LD50 for dermal exposure is >3640 mg/kg bw and the LC50 for inhalation exposure is >3000 mg/m3. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b5b17b2-0ad1-4b94-917e-3cf3ce781076/documents/6a871180-7862-4cc2-b960-15c6c040ab90_6e19dce7-7db7-4189-b3a1-274f6846e1dc.html,,,,,, Neodecanoic acid,26896-20-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b5b17b2-0ad1-4b94-917e-3cf3ce781076/documents/6a871180-7862-4cc2-b960-15c6c040ab90_6e19dce7-7db7-4189-b3a1-274f6846e1dc.html,,oral,LD50,"ca.1,000 mg/kg bw",adverse effect observed, Neodecanoic acid,26896-20-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b5b17b2-0ad1-4b94-917e-3cf3ce781076/documents/6a871180-7862-4cc2-b960-15c6c040ab90_6e19dce7-7db7-4189-b3a1-274f6846e1dc.html,,dermal,LD50,"> 3,640 mg/kg bw",no adverse effect observed, Neodecanoic acid,26896-20-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b5b17b2-0ad1-4b94-917e-3cf3ce781076/documents/6a871180-7862-4cc2-b960-15c6c040ab90_6e19dce7-7db7-4189-b3a1-274f6846e1dc.html,,inhalation,LC50,"> 3,000 mg/m3",no adverse effect observed, "Neodecanoic acid, cobalt salt",27253-31-2,"Acute oral toxicity:LD50(female rats)=1098 mg/kg bwAcute toxicity, dermal:Conduct of an acute dermal toxicity study is unjustified since dermal uptake is considered negligible (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006).Acute toxicity, inhalation:Testing is technically not feasible. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13cf29c0-41fd-4fc0-bb3e-616015cefe7a/documents/IUC5-830d1c28-308f-4be3-b835-00f584aee57e_1777135d-d84f-4f14-9fef-53ccbaec64ea.html,,,,,, "Neodecanoic acid, cobalt salt",27253-31-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13cf29c0-41fd-4fc0-bb3e-616015cefe7a/documents/IUC5-830d1c28-308f-4be3-b835-00f584aee57e_1777135d-d84f-4f14-9fef-53ccbaec64ea.html,,oral,LD50,"1,098 mg/kg bw",adverse effect observed, "Neodecanoic acid, iron salt",51818-55-4," No data on repeated dose toxicity from studies conducted with the target substance, Neodecanoic acid, iron salt, are available. Therefore, data from suitable read-across partners Iron trichloride hexahydrate and Neodecanoic acid was used to assess the specific toxicity of Neodecanoic acid, iron salt. For details and justification of read-across please refer to the report attached in section 13 of IUCLID. In sub-chronic (90-day) repeated dose toxicity studies with both Iron trichloride hexahydrate and Neodecanoic acid, effects on body weight were observed in rats. The study conducted with Neodecanoic acid is chosen as the one, from which the dose descriptor for risk assessment is chosen. A NOAEL of 700 mg/kg bw/day (HD) based on Neodecanoic acid could be derived, which corresponds to a NOAEL of 772 mg/kg bw/day for the target substance Neodecanoic acid, iron salt. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62c6dc3f-6dbc-476f-866e-dbecf0ffd237/documents/e9ecb238-7108-4223-99a6-a866edd17918_dcca805d-7901-4dfd-8627-1fb55453c1ea.html,,,,,, "Neodecanoic acid, iron salt",51818-55-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62c6dc3f-6dbc-476f-866e-dbecf0ffd237/documents/e9ecb238-7108-4223-99a6-a866edd17918_dcca805d-7901-4dfd-8627-1fb55453c1ea.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,772 mg/kg bw/day,,rat "Neodecanoic acid, iron salt",51818-55-4," For the oral route, suitable test data is available for the target substance Neodecanoic acid, iron salt. In an acute oral toxicity study conducted according to OECD 420, one animal treated at 2000 mg/kg bw was humanely killed approximately 3 hours after dosing due the severity of the clinical signs. A further four female rats received as a second step a single oral dose of 300 mg/kg bw. No deaths were noted in animals treated at 300 mg/kg bw. Therefore, the LD50 is >300 and < 2000 mg/kg bw. For the dermal and inhalation route, no acute toxicity data from studies conducted with the target substance are available. Thus, data from suitable read-across partners were used. For details and justification of read-across please refer to the report attached in section 13 of IUCLID. Read-across substances did not shown any acute toxicity via dermal or inhalation route. In conclusion, based on the available data, the target substance is not acutely toxic via the dermal and inhalation route, but classification as Acute Tox. 4, H302 for the oral route is warranted. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62c6dc3f-6dbc-476f-866e-dbecf0ffd237/documents/6d29f306-78b2-4b47-a993-dc8170546d95_dcca805d-7901-4dfd-8627-1fb55453c1ea.html,,,,,, "Neodecanoic acid, iron salt",51818-55-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62c6dc3f-6dbc-476f-866e-dbecf0ffd237/documents/6d29f306-78b2-4b47-a993-dc8170546d95_dcca805d-7901-4dfd-8627-1fb55453c1ea.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, "Neodecanoic acid, neodymium salt",106726-11-8, acute oral LD50 is > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2affce26-107a-4fbc-8942-4ba157e82d59/documents/ec9919de-f472-4339-810f-c28e9c29cfd7_a28f1002-7dd9-419d-bcc0-b44c993e747a.html,,,,,, "Neodecanoic acid, zinc salt, basic",84418-68-8," No repeated dose toxicity study with zinc neodecanoate basic is available, thus the repeated dose toxicity will be addressed with existing data on the individual assessment entities zinc and neodecanoate. In relevant and reliable repeated dose toxicity studies as well as supporting studies for both assessment entities of zinc neodecanoate basic, there were no toxicological findings reported that would justify a classification for specific target organ toxicity - repeated exposure, oral. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f08be60a-0bbd-4b0d-8915-198c3acc41f8/documents/37d7dd5e-ff7a-4ef2-9831-859acd98351b_14ccc743-422e-4552-96f6-eca41c6c48e3.html,,,,,, "Neodecanoic acid, zinc salt, basic",84418-68-8," No acute toxicity studies with zinc neodecanoate basic are available, thus the acute toxicity will be addressed with existing data on the dissociation products zinc and neodecanoate. Signs of acute oral or acute dermal toxicity are not expected for zinc neodecanoate basic, since the assessment entity zinc has not shown signs of acute oral toxicity (LD50 > 2000mg/kg) and acute dermal toxicity is considered to be low in view of the poor absorption by this route. The assessment entity neodecanoate has not shown signs of acute oral or acute dermal toxicity in experimental testing (LD50 > 2000mg/kg). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f08be60a-0bbd-4b0d-8915-198c3acc41f8/documents/1abb23ce-dd30-4ba9-92bb-ee32c323cc76_14ccc743-422e-4552-96f6-eca41c6c48e3.html,,,,,, "Neodecanoic acid, zirconium salt",39049-04-2," No repeated dose toxicity study with neodecanoic acid, zirconium salt is available, thus the repeated dose toxicity will be addressed with existing data on the assessment entities zirconium and neodecanoate. In relevant and reliable repeated dose toxicity studies as well as supporting studies for both moieties of neodecanoic acid, zirconium salt, there were no toxicological findings reported that would justify a classification. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfd9c622-9cca-4d29-b2ac-e67c20b6b44c/documents/3b394af0-2bed-47b7-aafe-f5b071a2d224_401586e1-911d-45e7-ba71-1d009eb7b5de.html,,,,,, "Neodecanoic acid, zirconium salt",39049-04-2,"In a GLP conform OECD 423 study, the acute oral LD50 value of the test item neodecanoic acid, zirconium salt was found to be between 300 and 2000 mg/kg bw in female Han:WIST rats.  No acute dermal or acute inhalation toxicity study with neodecanoic acid, zirconium salt is available, thus the acute dermal toxicity will be addressed with existing data on the dissociation products zirconium and neodecanoic acid. Signs of acute dermal or acute inhalation toxicity are not expected for neodecanoic acid, zirconium salt, since the two moieties zirconium and neodecanoic acid have not shown signs of acute dermal or acute inhalation toxicity in experimental testing. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfd9c622-9cca-4d29-b2ac-e67c20b6b44c/documents/f0e68f2b-6fa5-4a6d-9c09-33bae5e8e9fb_401586e1-911d-45e7-ba71-1d009eb7b5de.html,,,,,, "Neodecanoic acid, zirconium salt",39049-04-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfd9c622-9cca-4d29-b2ac-e67c20b6b44c/documents/f0e68f2b-6fa5-4a6d-9c09-33bae5e8e9fb_401586e1-911d-45e7-ba71-1d009eb7b5de.html,,oral,LD50,ca.500 mg/kg bw,adverse effect observed, Neodecanoyl chloride,40292-82-8,Neodecanoyl chlorde is of moderate oral toxicity and is very toxic via inhalation. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb76ea16-3b7f-4238-b7fe-6749dded44d3/documents/IUC5-27540f55-94e8-4e1b-835e-04134fbc7e28_31a34567-9a6d-4b9c-94c2-560baaf3cbd0.html,,,,,, Neodecanoyl chloride,40292-82-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb76ea16-3b7f-4238-b7fe-6749dded44d3/documents/IUC5-27540f55-94e8-4e1b-835e-04134fbc7e28_31a34567-9a6d-4b9c-94c2-560baaf3cbd0.html,,oral,LD50,"1,760 mg/kg bw",, Neodecanoyl chloride,40292-82-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb76ea16-3b7f-4238-b7fe-6749dded44d3/documents/IUC5-27540f55-94e8-4e1b-835e-04134fbc7e28_31a34567-9a6d-4b9c-94c2-560baaf3cbd0.html,,inhalation,LC50,400 mg/m3,, Neodymium oxide,1313-97-9,"REPEATED DOSE TOXICITY: ORAL NOEL male 300 mg/kg bw/day, rat (haematological and clinical chemistry changes); NOAEL male 1000 mg/kg bw/day, rat; NOAEL female 300 mg/kg bw/day, rat (a reduction in bodyweight gain during the lactation period, haematological changes and clinical chemistry changes at 1000 mg/kg bw/day), OECD 422, Charles River (2013). REPEATED DOSE TOXICITY: ORAL In a sub-chronic repeated dose toxicity study in rats conducted according to OECD test guideline 408 and 424, the NOAEL for local effects (stomach irritation) to rats was below 100 mg/kg bw/day in males and 100 mg/kg bw/day in females. Neodymium oxide was poorly absorbed and, in view of the 10 % reduction of weight gain by females receiving 1000 mg/kg bw/day, which was statistically significant, the systemic NOAEL is considered to be 300 mg/kg bw/day in females and 1000 mg/kg bw/day in males. REPEATED DOSE TOXICITY: INHALATION No study available, a data waiver has been submitted to address this endpoint. REPEATED DOSE TOXICITY: INHALATION (NANO) The 28-day repeat inhalation toxicity of the test material was assessed by exposing male rats to nano-sized test mateial-containing aerosols via a nose-only inhalation system at doses of 0 mg/m^3, 0.5 mg/m^3, 2.5 mg/m^3, and 10 mg/m^3 for 6 hr/day, 5 days/week over a 28-day period, followed by a 28-day recovery period. During the experimental period, clinical signs, body weight, haematologic parameters, serum biochemical parameters, necropsy findings, organ weight, and histopathological findings were examined; test material distribution in the major organs and blood, bronchoalveolar lavage fluid (BALF), and oxidative stress in lung tissues were analysed. Under the conditions of this study the test material was reported to resulted in increased lung weight, histopathological changes such as PAP and infiltration of inflammatory cells (2.5 and 10 mg/m^3 dose groups only), and increased counts of total cells, macrophages, and neutrophils, and levels of IL-6, TNF-α, albumin, and LDH in BALF for all treatment groups. However, the severity of PAP was low for the 0.5 mg/m^3 group. After a 4-week recovery period, these changes generally recovered for the 0.5 mg/m^3 group, but deteriorated in the 10 mg/m3 group. Under the present experimental conditions, in male rats, the LOAEC of nano-sized test material was determined to be 0.5 mg/m^3, and the target organ was determined to be the lung. REPEATED DOSE TOXICITY: DERMAL No study available, a data waiver has been submitted to address this endpoint. The critical effect for this substance is the kidney histpathology reported in the OCED 422 study. These effects were not reported in the OECD 408 study, however the OECd 408 study is confounded by the fact that there is uncertainty on whether the animals received adequate doses of the substance. One likely explanation is that the kidney effects observed in the shorter OECD 422 study is an adaptive response and that following a longer period of dosing this effect is no longer present. Another explanation for the difference in effect profile between the two studies could be the result of dosing issues encountered in the OECD 408 study has affected the effect profile in that study. With this in mind the kidney effects observed in the OECD 422 study is employed as the critical effect and calculation of a conservative DNEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d5a0c618-5203-49aa-95a3-1187ea170754/documents/IUC5-b65eaaf7-cd66-475e-8cc1-c5221469ea49_66311b43-3240-491f-a407-6edc0fbb2498.html,,,,,, Neodymium oxide,1313-97-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d5a0c618-5203-49aa-95a3-1187ea170754/documents/IUC5-b65eaaf7-cd66-475e-8cc1-c5221469ea49_66311b43-3240-491f-a407-6edc0fbb2498.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Neodymium oxide,1313-97-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d5a0c618-5203-49aa-95a3-1187ea170754/documents/IUC5-b65eaaf7-cd66-475e-8cc1-c5221469ea49_66311b43-3240-491f-a407-6edc0fbb2498.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Neodymium oxide,1313-97-9,ACUTE TOXICITY: VIA THE ORAL ROUTEAll three studies available for this endpoint report an acute oral LD50 in the rat of >5000 mg/kg bodyweight. ACUTE TOXICITY: VIA INHALATION ROUTEThe 4 hour LC50 in the rat was > 4.98 mg/L. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d5a0c618-5203-49aa-95a3-1187ea170754/documents/IUC5-f3761007-483e-414a-81e8-8cc17d47321e_66311b43-3240-491f-a407-6edc0fbb2498.html,,,,,, Neodymium trichloride,10024-93-8," Acute oral toxicity on test material Under the conditions of this study, the oral LD50 value of the test material in Sprague-Dawley rats was estimated to be 5068 mg/kg. Acute dermal toxicity Under the conditions of this study no mortality was observed at 2000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/860153ee-ecad-4817-9041-f5c26de871db/documents/08c96c85-8b36-4bd6-ad51-eb0559762e8a_825f7d75-8ced-40cc-abe7-0c9252fb5692.html,,,,,, Neodymium trichloride,10024-93-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/860153ee-ecad-4817-9041-f5c26de871db/documents/08c96c85-8b36-4bd6-ad51-eb0559762e8a_825f7d75-8ced-40cc-abe7-0c9252fb5692.html,,oral,LD50,"5,068 mg/kg bw",adverse effect observed, Neodymium trifluoride,13709-42-7,A screening for reproductive / developmental toxicity study has been conducted according to OECD Guideline 422. Upon review of the draft study report the validity of the study has been called into question because of the high number of non-pregnant females and total litter losses observed in the treated groups during the study period. Discussions between the laboratory which conducted the study and representatives of the registrants are ongoing. As soon as this matter is resolved a registration update will be provided to include data to address this endpoint. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/4fd8ec0e-a4c1-4266-9d40-460d1b21209c/documents/IUC5-b5caa9ee-e431-40dd-9c00-0f7f1e9db122_a4197768-2aa3-407d-9780-7ef3d18fa6d6.html,,,,,, Neodymium trifluoride,13709-42-7,"ACUTE TOXICITY: VIA THE ORAL ROUTEAll three studies report an acute oral LD50 in the rat of >5000 mg/kg bodyweight. ACUTE TOXICITY: VIA INHALATION ROUTEIn accordance with Section 2 of Annex XI of Regulation (EC) No. 1907/2006, the acute toxicity by inhalation study, listed under point 8.5.2 of Annex VIII of the same Regulation, had been waived as it is not technically feasible to conduct the study. The sticky nature of the test substance made it impossible to generate the dust atmosphere required for the study.ACUTE TOXICITY: VIA DERMAL ROUTEThe dermal LD0 in the rat was >2000 mg/kg.ACUTE TOXICITY: OTHER ROUTESthe LD0 of the test material to the rat is >5000 mg/kg when administered via the intraperitoneal route. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4fd8ec0e-a4c1-4266-9d40-460d1b21209c/documents/IUC5-d7f0700b-1d0f-4ec0-a212-fcdecaed74b8_a4197768-2aa3-407d-9780-7ef3d18fa6d6.html,,,,,, Neodymium trinitrate,10045-95-1,"Acute toxicity: oral:A K2 acute oral toxicity test was performed in female Sprague-Dawley rats according to a guideline similar to OECD Guideline 401 (Bruce DW, 1963). This study was selected as key study since this is the only available reliable study (K2). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f34c6cd6-4aa0-4139-8329-0139a782294f/documents/IUC5-078f2238-a33d-4dde-98da-ab29fca3cdc2_1e8a7627-4045-40ec-869b-8b6151ddb316.html,,,,,, Neodymium trinitrate,10045-95-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f34c6cd6-4aa0-4139-8329-0139a782294f/documents/IUC5-078f2238-a33d-4dde-98da-ab29fca3cdc2_1e8a7627-4045-40ec-869b-8b6151ddb316.html,,oral,LD50,"2,750 mg/kg bw",no adverse effect observed, Neodymium(3+) acetate,6192-13-8," Read-across performed with structurally similar substance (Dineodymium Tricarbonate) The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight. Read-across performed with structurally similar substance (Neodymium Trifluoride) The oral LD0 (males and females) was > 5000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on the results of this study in accordance with EU criteria. Read-across performed with structurally similar substance (Neodymium Trinitrate) Under the conditions of this study, the acute oral LD50 of neodymium nitrate in female rats was determined to be 2750 mg/kg. Read-across performed with structurally similar substance (Neodymium Trioxide) The oral LD50 (males and females) was > 5000 mg/kg bw and therefore the test material is not classified for acute oral toxicity based on the results of this study according to EU criteria. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/effe530e-f959-47c5-bec8-7299ace98d25/documents/797bec3c-3b82-4b05-8659-eeea2ab44c73_04470ba8-cbcc-4269-817e-f31169521229.html,,,,,, Neodymium(3+) acetate,6192-13-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/effe530e-f959-47c5-bec8-7299ace98d25/documents/797bec3c-3b82-4b05-8659-eeea2ab44c73_04470ba8-cbcc-4269-817e-f31169521229.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N-ethyl-4-[[4-(ethylamino)-m-tolylphenyl][4-(ethylimino)-3-methylcyclohexa-2,5-dien-1-ylidene]methyl]-m-toluidine monoacetate",94349-52-7,"Based on the findings with the acute toxic class method, an LD50 of > 350 and < 1400 mg/kg bw was determined for male and female Wistar rats (recalculated based on dye content in registered substance (74% w/w) versus tested material (52% w/w)). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e2ced48-d3e0-48b5-bdfe-405a7f0d9880/documents/a2e49202-5d4f-4c0a-9f1d-cb0c97d07807_5fb47383-cf69-456c-b42e-748f7604899e.html,,,,,, "N-ethyl-4-[[4-(ethylamino)-m-tolylphenyl][4-(ethylimino)-3-methylcyclohexa-2,5-dien-1-ylidene]methyl]-m-toluidine monoacetate",94349-52-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e2ced48-d3e0-48b5-bdfe-405a7f0d9880/documents/a2e49202-5d4f-4c0a-9f1d-cb0c97d07807_5fb47383-cf69-456c-b42e-748f7604899e.html,,oral,LD50,350 mg/kg bw,adverse effect observed, N-ethylmethacrylamine,18328-90-0,Published summaries of acute oral and dermal toxicity studies are available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d43a977-8452-4fd4-b63b-41c5ce3d6591/documents/IUC5-5a2bc9cf-0a54-4d80-9577-a18a1469360f_f987666d-ef5c-4fa3-9341-fa25064165c2.html,,,,,, N-ethylmethacrylamine,18328-90-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d43a977-8452-4fd4-b63b-41c5ce3d6591/documents/IUC5-5a2bc9cf-0a54-4d80-9577-a18a1469360f_f987666d-ef5c-4fa3-9341-fa25064165c2.html,,oral,LD50,50 mg/kg bw,adverse effect observed, N-ethylmethacrylamine,18328-90-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d43a977-8452-4fd4-b63b-41c5ce3d6591/documents/IUC5-5a2bc9cf-0a54-4d80-9577-a18a1469360f_f987666d-ef5c-4fa3-9341-fa25064165c2.html,,dermal,LD50,200 mg/kg bw,adverse effect observed, N-ethyl-N-[2-[1-(2-methylpropoxy)ethoxy]ethyl]-4-(phenylazo)aniline,34432-92-3, Repeated dose toxicity: oral 90-day study: no observed adverse effect level (NOAEL) for C.I. Solvent Yellow 124 is considered to be 10 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70cc579d-8e34-43b6-8979-dc1bccd8882d/documents/2b6a4ae4-788f-4010-83e9-f3cc4d8644bd_5fb0e71b-efb0-4549-a360-39e1d6c62838.html,,,,,, N-ethyl-N-[2-[1-(2-methylpropoxy)ethoxy]ethyl]-4-(phenylazo)aniline,34432-92-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70cc579d-8e34-43b6-8979-dc1bccd8882d/documents/2b6a4ae4-788f-4010-83e9-f3cc4d8644bd_5fb0e71b-efb0-4549-a360-39e1d6c62838.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat N-ethyl-N-[2-[1-(2-methylpropoxy)ethoxy]ethyl]-4-(phenylazo)aniline,34432-92-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70cc579d-8e34-43b6-8979-dc1bccd8882d/documents/IUC5-c0b0ad28-47c5-4340-8b79-99a714fc126c_5fb0e71b-efb0-4549-a360-39e1d6c62838.html,,oral,LD50,300 mg/kg bw,adverse effect observed, N-ethyl-N-[2-[1-(2-methylpropoxy)ethoxy]ethyl]-4-(phenylazo)aniline,34432-92-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70cc579d-8e34-43b6-8979-dc1bccd8882d/documents/IUC5-c0b0ad28-47c5-4340-8b79-99a714fc126c_5fb0e71b-efb0-4549-a360-39e1d6c62838.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, N-ethyl-o(or p)-toluenesulphonamide,8047-99-2, Repeated dose toxicity oral (OECDTG 408): NOAEL 100 mg/kg/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e11d2e64-21ef-4de4-ae0c-10417d4add7d/documents/9e775e2f-9cac-4046-abbb-d16eaafee92b_a71a44d9-7c71-49a1-9694-0d5432aaa094.html,,,,,, N-ethyl-o(or p)-toluenesulphonamide,8047-99-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e11d2e64-21ef-4de4-ae0c-10417d4add7d/documents/9e775e2f-9cac-4046-abbb-d16eaafee92b_a71a44d9-7c71-49a1-9694-0d5432aaa094.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat N-ethyl-o(or p)-toluenesulphonamide,8047-99-2, Acute oral toxicity (OECD TG 401): LD50 >5800 mg/kg bw Acute dermal toxicity (OECD TG 402): LD50 >7945 mg/kg bw Acute inhalation toxicity: not classified ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e11d2e64-21ef-4de4-ae0c-10417d4add7d/documents/4414cc2d-aeca-45ad-8160-8ab1619d2a94_a71a44d9-7c71-49a1-9694-0d5432aaa094.html,,,,,, N-ethyl-o(or p)-toluenesulphonamide,8047-99-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e11d2e64-21ef-4de4-ae0c-10417d4add7d/documents/4414cc2d-aeca-45ad-8160-8ab1619d2a94_a71a44d9-7c71-49a1-9694-0d5432aaa094.html,,oral,LD50,"5,800 mg/kg bw",no adverse effect observed, N-ethyl-o(or p)-toluenesulphonamide,8047-99-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e11d2e64-21ef-4de4-ae0c-10417d4add7d/documents/4414cc2d-aeca-45ad-8160-8ab1619d2a94_a71a44d9-7c71-49a1-9694-0d5432aaa094.html,,dermal,LD50,"7,945 mg/kg bw",no adverse effect observed, N-ethylpropylamine,20193-20-8,Oral: NOAEL = 600 mg/kg bw; rat; according to OECD TG 422; GLP; K1 Inhalation: no information available Dermal: no information available ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a092afd-6ef6-443c-ad32-4b624ed4bff5/documents/de183399-83c0-4718-88f3-253e601d5824_0aaa598f-e680-4f22-b34e-545f77b92bef.html,,,,,, N-ethylpropylamine,20193-20-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a092afd-6ef6-443c-ad32-4b624ed4bff5/documents/de183399-83c0-4718-88f3-253e601d5824_0aaa598f-e680-4f22-b34e-545f77b92bef.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat N-ethylpropylamine,20193-20-8,Oral: LD50 = 496 mg/kg bw; rat; no guideline; pre-GLP; K2 Inhalation: LC100 = 375 mg/L; rat; no guideline; pre-GLP; K2 Dermal: LD50 > 200 mg/kg bw; rabbit; no guideline; pre-GLP; K2 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a092afd-6ef6-443c-ad32-4b624ed4bff5/documents/IUC5-f6f386d4-cd3c-4847-9a9e-ad01b54177fd_0aaa598f-e680-4f22-b34e-545f77b92bef.html,,,,,, N-ethylpropylamine,20193-20-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a092afd-6ef6-443c-ad32-4b624ed4bff5/documents/IUC5-f6f386d4-cd3c-4847-9a9e-ad01b54177fd_0aaa598f-e680-4f22-b34e-545f77b92bef.html,,oral,LD50,496 mg/kg bw,adverse effect observed, N-ethylpropylamine,20193-20-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a092afd-6ef6-443c-ad32-4b624ed4bff5/documents/IUC5-f6f386d4-cd3c-4847-9a9e-ad01b54177fd_0aaa598f-e680-4f22-b34e-545f77b92bef.html,,dermal,discriminating dose,200 mg/kg bw,no adverse effect observed, N-ethylpropylamine,20193-20-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a092afd-6ef6-443c-ad32-4b624ed4bff5/documents/IUC5-f6f386d4-cd3c-4847-9a9e-ad01b54177fd_0aaa598f-e680-4f22-b34e-545f77b92bef.html,,inhalation,LC100,375 mg/L,adverse effect observed, N-glycyl-L-tyrosine,658-79-7,"In a 14-day Dose Range Finding (DRF) toxicity study where N-Glycyl-L-tyrosine was administered by oral gavage to Wistar rats for 14 consecutive days, at 1000 mg/kg bw/day there were no specific adverse effects identified. The daily administration of N-Glycyl-L-tyrosine anhydrous by oral gavage to Wistar rats at dose levels up to 1000 mg/kg bw/day in a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to OECD TG 422 did not result in any toxicological relevant finding. Thus, the overall NOEL of this study is 1000 mg/kg bw/day covering systemic and reproductive toxicity of the parenteral generation as well as development and survival of the F1 generation. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): This study followed the procedures indicated by the following internationally accepted guideline and recommendations: • OECD Guideline No. 422, Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test in the Rat (2016) • OECD No. 43 Guidance Document on Mammalian Reproductive Toxicity Testing and Assessment (2008) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f242393c-b749-419d-a70b-cd5d7162a0ea/documents/b01e51b6-bc54-4d41-b12d-ad1c950b7abf_89460ce0-a67d-4d62-ae74-ff03a9e6f9d0.html,,,,,, N-glycyl-L-tyrosine,658-79-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f242393c-b749-419d-a70b-cd5d7162a0ea/documents/b01e51b6-bc54-4d41-b12d-ad1c950b7abf_89460ce0-a67d-4d62-ae74-ff03a9e6f9d0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat N-glycyl-L-tyrosine,658-79-7," - acute oral toxicity with N-glycyl-L-tyrosine dihydrate, LD50 > 2150 mg/kg bw corresponding to 2000 mg/kg bw N-glycyl-L-tyrosine, OECD guideline 401, GLP, Wistar rats, observation period after oral application 14 days, - acute toxicity: other routes: LD50 > 5956 mg/kg bw, non-guideline study, either 20 or 25 mmol/kg bw at 250 ml/kg bw N-glycyl-L-tyrosine was intravenously administered to Sprague Dawley rats within 8h, observation period after administration 14 days ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f242393c-b749-419d-a70b-cd5d7162a0ea/documents/7c05bb29-25e8-4005-bae5-f84fd6c48ade_89460ce0-a67d-4d62-ae74-ff03a9e6f9d0.html,,,,,, N-glycyl-L-tyrosine,658-79-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f242393c-b749-419d-a70b-cd5d7162a0ea/documents/7c05bb29-25e8-4005-bae5-f84fd6c48ade_89460ce0-a67d-4d62-ae74-ff03a9e6f9d0.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, N-glycyl-L-tyrosine,658-79-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f242393c-b749-419d-a70b-cd5d7162a0ea/documents/7c05bb29-25e8-4005-bae5-f84fd6c48ade_89460ce0-a67d-4d62-ae74-ff03a9e6f9d0.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Nickel bis(2-ethylhexanoate),4454-16-4,"- Acute oral toxicity:In a GLP conform OECD 423 study, the acute oral LD50 value of the test item nickel bis(2-ethylhexanoate) was found to be 300 < LD50 ≤ 2000 mg/kg bw in female Han:WIST rats. - Acute dermal toxicity:For Nickel moiety, data on dermal toxicity of NiSO4 was selected: up to 100 mg/kg bw, no clinical signs of poisoning or mortality were found. Concerning 2-ethylhexanoic acid, data on dermal toxicity are limited and results of two publications are added to this dossier. These indicate that 2-ethylhexanoic acid is readily absorbed by the skin and the LD50 appeared to be between 3.6 and 4.5 g/kg bw. The few studies available do not allow determination of an exact effect level for acute dermal toxicity of Nickel bis(2-ethylhexanoate) (see discussion). However its LD50 for dermal exposure will probably be between 625 mg/kg (based on the data for Nickel) and 5000 mg/kg bw (based on the data for 2-ethylhexanoic acid). The key value is therefore expressed as a discriminating dose based on the NOEL for acute dermal exposure to Nickel of 100 mg/kg bw, extrapolated to Nickel bis(2-ethylhexanoate). - Acute inhalation toxicity:This substance is a waxy solid which is not capable in creating an inhalable atmosphere, thus testing is technically not feasible. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ba8bf89-609a-4501-8352-d4ed2bb09684/documents/f3e143a5-ab55-44e4-8023-49d90ea1e867_9b7d0cb9-8bbd-444c-bfa0-3ec5432bbabf.html,,,,,, Nickel bis(2-ethylhexanoate),4454-16-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ba8bf89-609a-4501-8352-d4ed2bb09684/documents/f3e143a5-ab55-44e4-8023-49d90ea1e867_9b7d0cb9-8bbd-444c-bfa0-3ec5432bbabf.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, Nickel bis(dibutyldithiocarbamate),13927-77-0, The NOAEL value for repeated dose oral toxicity was 0.2 mg/kg bw/day in rats. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b6aa03f-337e-4602-81e9-73225e670cd3/documents/18c82a7b-df85-4ffc-b36a-f9da9c829d04_1f35316f-f558-4913-93fb-fea9d489f570.html,,,,,, Nickel bis(dibutyldithiocarbamate),13927-77-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b6aa03f-337e-4602-81e9-73225e670cd3/documents/18c82a7b-df85-4ffc-b36a-f9da9c829d04_1f35316f-f558-4913-93fb-fea9d489f570.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,0.2 mg/kg bw/day,,rat Nickel bis(dibutyldithiocarbamate),13927-77-0, The LD50 value for acute oral toxicity was >5000 mg/kg bw in rats. The LC50 value for acute inhalation toxicity was >0.416 mg/L air in rats. The LD50 value for acute dermal toxicity was >2000 mg/kg bw in rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b6aa03f-337e-4602-81e9-73225e670cd3/documents/3a29121c-373b-4fd6-a1a5-9638303b5643_1f35316f-f558-4913-93fb-fea9d489f570.html,,,,,, Nickel bis(dibutyldithiocarbamate),13927-77-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b6aa03f-337e-4602-81e9-73225e670cd3/documents/3a29121c-373b-4fd6-a1a5-9638303b5643_1f35316f-f558-4913-93fb-fea9d489f570.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Nickel bis(dibutyldithiocarbamate),13927-77-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b6aa03f-337e-4602-81e9-73225e670cd3/documents/3a29121c-373b-4fd6-a1a5-9638303b5643_1f35316f-f558-4913-93fb-fea9d489f570.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Nickel bis(dibutyldithiocarbamate),13927-77-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b6aa03f-337e-4602-81e9-73225e670cd3/documents/3a29121c-373b-4fd6-a1a5-9638303b5643_1f35316f-f558-4913-93fb-fea9d489f570.html,,inhalation,discriminating conc.,416 mg/m3,no adverse effect observed, Nickel bis(dihydrogen phosphate),18718-11-1," Value used for CSA (read-across from Nickel sulphate): NOAEL (oral, systemic, animal): 10 mg Ni sulphate hexahydrate /kg bw/day (or 2.2 mg Ni/kg bw/day) (Heim et al. 2007) NOAEC (inhalation, local, animal): 0.12 mg Ni sulphate hexahydrate /m³ air ( or 0.027 mg Ni/m3air) (Dunnick et al., 1995) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2ea4a466-1cd9-4820-8655-16db148f633a/documents/6bb2932b-fb7c-4acc-b701-699b0c7b0ec0_b40bf352-0372-476b-89de-432fc0e20f97.html,,,,,, Nickel bis(dihydrogen phosphate),18718-11-1," Value used for CSA (read-across from Nickel sulphate or Nickel ion): NOAEL (oral, systemic, animal): 100 mg NiSO4.6H2O/kg bw(22 mg Ni/kg bw/day) (FDRL, 1983) LOAEL (oral, systemic, human data): 0.012 mg Ni (Ni ion)/kg bw/day released from metallic nickel in water and food contact material (Nielsen et al 1999) NOAEC (inhalation, systemic, animal): 0.53 mg NiSO4.6H2O/L air (120 mg Ni/m3) (EPSL, 2009b) LOAEC (inhalation, local, animal data): 0.7 mg Ni/m3(DNEL calculation is based on 16-day repeated dose study-Benson et al, 1988; no acute data was available) An acute local inhalation DNEL is derived based on the lung effects (e.g. lung inflammation) associated with nickel sulphate inhalation.  The shortest-term study available examining those effects in animals is a 16-day repeated exposure study.  An adjustment factor was derived to extrapolate the results from the repeated exposure study to an equivalent effect concentration in a 4 hr acute exposure.  SeeAppendix C3for more information. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ea4a466-1cd9-4820-8655-16db148f633a/documents/1a3fa006-817e-411e-aa9d-ac3c73b83ca1_b40bf352-0372-476b-89de-432fc0e20f97.html,,,,,, Nickel Cobalt Manganese Hydroxide,189139-63-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c2584e9-55b6-4b8b-a177-71b4bfcbe614/documents/e8c15af6-ad18-4349-a69b-8611c48040f6_40cdc450-1c1a-4949-862c-267cabc42c46.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Nickel di(acetate),373-02-4," Value used for CSA (read-across from Nickel sulphate): NOAEL (oral, systemic, animal): 10 mg Ni sulphate hexahydrate /kg bw/day (or 2.2 mg Ni/kg bw/day) (Heim et al. 2007) NOAEC (inhalation, local, animal): 0.12 mg Ni sulphate hexahydrate /m³ air ( or 0.027 mg Ni/m3air) (Dunnick et al., 1995) LOAEC(inhalation, local, animal): 0.25 mg nickel sulphate hexahydrate/m3(or 0.056 mg Ni/m3)(Dunnick et al., 1995) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b64d515e-1c3f-4941-ac5d-043470a1fe1e/documents/17527e12-abce-4bd2-aed2-b5125e81392f_b2d53587-119b-4fa7-83dc-f7384d5f514d.html,,,,,, Nickel di(acetate),373-02-4," NOAEL (oral, systemic, animal): 175 mg/kg bw (42 mg Ni/kg bw/day) (EPSL, 2008) LOAEL (oral, systemic, human data; read-across): 0.012 mg Ni (Ni ion)/kg bw/day released from metallic nickel in water and food contact material (Nielsen et al 1999) NOAEC (inhalation, systemic, animal; read-across): 0.53 mg NiSO4.6H2O/L air (120 mg Ni/m3) (EPSL, 2009) LOAEC (inhalation, local, animal; read-across): 0.7 mg Ni/m3 (DNEL calculation is based on 16-day repeated dose study-Benson et al, 1988; no acute data was available) An acute local inhalation DNEL is derived based on the lung effects (e.g. lung inflammation) associated with nickel sulphate inhalation.  The shortest-term study available examining those effects in animals is a 16-day repeated exposure study.  An adjustment factor was derived to extrapolate the results from the repeated exposure study to an equivalent effect concentration in a 4 hr acute exposure.  See Appendix C3 for more information. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b64d515e-1c3f-4941-ac5d-043470a1fe1e/documents/48347f51-a89a-4569-8a25-ccc3034c8014_b2d53587-119b-4fa7-83dc-f7384d5f514d.html,,,,,, Nickel di(acetate),373-02-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b64d515e-1c3f-4941-ac5d-043470a1fe1e/documents/48347f51-a89a-4569-8a25-ccc3034c8014_b2d53587-119b-4fa7-83dc-f7384d5f514d.html,,oral,LD50,550 mg/kg bw,adverse effect observed, Nickel di(acetate),373-02-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b64d515e-1c3f-4941-ac5d-043470a1fe1e/documents/48347f51-a89a-4569-8a25-ccc3034c8014_b2d53587-119b-4fa7-83dc-f7384d5f514d.html,,inhalation,LC50,2.48 mg/m3,adverse effect observed, Nickel difluoride,10028-18-9,"Oral: A 2-year oral carcinogenicity study reported a NOAEL of 10 mg/kg body weight/day (2.2 mg Ni/kg bw/day) and a LOAEL of 30 mg/kg body weight/day (6.7 mg Ni/kg bw/day), as tested with the related substance NiSO4 (Heim et al. 2007). The LOAEL of 6.7 mg Ni/kg bw/day based on reduced body weight and increased mortality together with a NOAEL of 2.2 mg Ni/kg bw/day is taken forward to the risk characterisation. A summary on this topic is included in a background document in section 7.5.1 of the IUCLID file. Inhalation: A carcinogenicity study via inhalation was performed with the related substance NiSO4 (NTP, 1996). Chronic lung inflammation including lung fibrosis results from long-term exposure via inhalation to a concentration of 0.056 mg Ni/m3 or 0.25 mg nickel sulphate hexahydrate/m3. A NOAEC of 0.12 mg/m³ (0.027 mg Ni/m3, MMAD = 2.5 µm) was identified for these effects (Dunnick et al., 1995). A summary on this topic is included in section 7.5.2 of the IUCLID file. Dermal: It was not possible to determine a NOAEL/LOAEL for the dermal route based on the available information. Testing by the dermal route has been waived as Nickel is already classified as skin sensitising and data are available for a second route of exposure, i.e. inhalation.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e2d98bb-b608-44c1-830a-1925b7179831/documents/IUC5-fc439204-64e7-41a7-a36f-3f52fee10d8a_ae1c253d-914f-4da5-b59b-4436d3b4ebc8.html,,,,,, Nickel difluoride,10028-18-9,"ACUTE ORAL TOXICITY: The oral LD50 in rats was determined to be 178 mg/kg bw of Nickel fluoride anhydrous in a key study contucted according to OECD guideline 425 (K1; Eurofins, 2008).   ACUTE INHALATION TOXICITY: Data generated with the related substance NiSO4 is used for endpoint coverage. The LC50 for acute inhalation toxicity in rats was determined to be 2.48 mg NiSO4.6H2O/L air for males and females, corresponding to 0.91 mg/L of Nickel Fluoride (i.e. 910 mg/m³) in a key study conducted according to OECD guideline 403 (K1; EPSL, 2009).   ACUTE DERMAL TOXICITY: No reliable data via dermal exposure are available. However, this endpoint is waived for the dermal route as reliable data are available for the oral and inhalation route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e2d98bb-b608-44c1-830a-1925b7179831/documents/IUC5-5bf5c409-5f83-49db-bee5-703697996c92_ae1c253d-914f-4da5-b59b-4436d3b4ebc8.html,,,,,, Nickel difluoride,10028-18-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e2d98bb-b608-44c1-830a-1925b7179831/documents/IUC5-5bf5c409-5f83-49db-bee5-703697996c92_ae1c253d-914f-4da5-b59b-4436d3b4ebc8.html,,oral,LD50,178 mg/kg bw,adverse effect observed, Nickel difluoride,10028-18-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e2d98bb-b608-44c1-830a-1925b7179831/documents/IUC5-5bf5c409-5f83-49db-bee5-703697996c92_ae1c253d-914f-4da5-b59b-4436d3b4ebc8.html,,inhalation,LC50,910 mg/m3,adverse effect observed, Nickel dihydroxide,12054-48-7," Value used for CSA: NOAEL (oral, systemic, animal data): 2.2 mg Ni/kg bw/day read-across from nickel sulphate hexahydrate (Heim et al., 2007) LOAEC (inhalation, local, animal data): 0.11 mg Ni/m3 read-across from nickel subsulphide (based on 0.15 mg Ni subsulphide/m3; Dunnick et al., 1995) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3772b326-5a76-4f65-b13d-92e8cb90d319/documents/e88f239b-76ea-43cd-bd11-34e1b9cd868d_7ac85b00-00ba-4646-83a8-2f5740b39c21.html,,,,,, Nickel dihydroxide,12054-48-7,"Value used for CSA: NOAEL (oral, systemic, animal data): 430 mg Ni/kg bw (Reagan 1996, FDRL 1983) NOAEC (inhalation, systemic, animal data): 3,900 mg Ni/m3 read-across from Ni oxide (EPSL, 2009, 2010)   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3772b326-5a76-4f65-b13d-92e8cb90d319/documents/a0be3de6-ef0f-4c44-81f3-e017a2f4aeb1_7ac85b00-00ba-4646-83a8-2f5740b39c21.html,,,,,, Nickel dinitrate,13138-45-9," Value used for CSA (read-across from Nickel sulphate): NOAEL (oral, systemic, animal): 10 mg Ni sulphate hexahydrate /kg bw/day (or 2.2 mg Ni/kg bw/day) (Heim et al. 2007) NOAEC (inhalation, local, animal): 0.12 mg Ni sulphate hexahydrate /m³ air ( or 0.027 mg Ni/m3air) (Dunnick et al., 1995) LOAEC(inhalation, local, animal): 0.25 mg nickel sulphate hexahydrate/m3(or 0.056 mg Ni/m3)(Dunnick et al., 1995) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f22d3b03-4392-449c-91a5-ed9412a6d629/documents/76377e57-873f-4e5e-aeae-a1fb4e9f120a_69a2a311-411a-4591-89ed-89c2c42fdd16.html,,,,,, Nickel dinitrate,13138-45-9," Value used for CSA (read-across from Nickel sulphate or Nickel ion): NOAEL (oral, systemic, animal): 100 mg NiSO4.6H2O/kg bw(22 mg Ni/kg bw/day) (FDRL, 1983) LOAEL (oral, systemic, human data): 0.012 mg Ni (Ni ion)/kg bw/day released from metallic nickel in water and food contact material (Nielsen et al 1999) NOAEC (inhalation, systemic, animal): 0.53 mg NiSO4.6H2O/L air (120 mg Ni/m3) (EPSL, 2009a) LOAEC (inhalation, local, animal data): 0.7 mg Ni/m3(DNEL calculation is based on 16-day repeated dose study-Benson et al, 1988; no acute data was available) An acute local inhalation DNEL is derived based on the lung effects (e.g. lung inflammation) associated with nickel sulphate inhalation.  The shortest-term study available examining those effects in animals is a 16-day repeated exposure study.  An adjustment factor was derived to extrapolate the results from the repeated exposure study to an equivalent effect concentration in a 4 hr acute exposure.  See Appendix C3 for more information. (Oral, local values are not applicable; Dermal, local or systemic, values are not applicable)   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f22d3b03-4392-449c-91a5-ed9412a6d629/documents/38b8e37f-16b6-46d8-8662-d107a8c9a00c_69a2a311-411a-4591-89ed-89c2c42fdd16.html,,,,,, Nickel iron chromite black spinel,71631-15-7,Acute oral toxicity: LD50 > 2000 mg/kg bw (equivalent or similar to OECD 423; Non-GLP compliant)Acute inhalation toxicity: LC50 (rats; 4 hours) > 5.06 mg/L air (actual concentration) (OECD 436 (2009); GLP compliant) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1fe09ee-a5d1-4ba0-bbc6-1d2b29194356/documents/IUC5-e3ec02eb-5791-4e5c-86a7-2452a4c0f2cd_e3e1c51d-c41a-4732-958a-20e750a3c619.html,,,,,, Nickel monoxide,1313-99-1,"Value used for CSA: NOAEL (oral, systemic, animal data): 2.2 mg Ni/kg bw/day read-across from Ni sulphate hexahydrate (Heim et al 2007) LOAEC (inhalation, local, animal data): 0.056 mg Ni/m3(Dunnick et al, 1995) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a079b178-62d7-4a87-8e9f-bc9aeec888dc/documents/27afccac-36fc-45fa-b019-e76aa6bcbe90_fb0bb2a8-e167-4de5-8781-e0cd7bd9efb9.html,,,,,, Nickel monoxide,1313-99-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a079b178-62d7-4a87-8e9f-bc9aeec888dc/documents/27afccac-36fc-45fa-b019-e76aa6bcbe90_fb0bb2a8-e167-4de5-8781-e0cd7bd9efb9.html,Chronic toxicity – systemic effects,oral,NOAEL,2.2 mg/kg bw/day,,rat Nickel monoxide,1313-99-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a079b178-62d7-4a87-8e9f-bc9aeec888dc/documents/27afccac-36fc-45fa-b019-e76aa6bcbe90_fb0bb2a8-e167-4de5-8781-e0cd7bd9efb9.html,Chronic toxicity – systemic effects,inhalation,LOAEC,0.5 mg/m3,,rat Nickel monoxide,1313-99-1," Value used for CSA: NOAEL (oral, systemic, animal data): >11,000 mg/kg for nickel oxide green (>8,500 mg Ni/kg/day) (EPSL, 2008)                                                                                   9,990 mg/kg for nickel oxide black (6,200 mg Ni/kg/day) (EPSL, 2009) NOAEL (oral, systemic, human data): 0.012 mg Ni (Ni ion)/kg bw/day; based on exacerbated existing dermatitis            (Nielsen et al., 1999) NOAEC (inhalation, systemic, animal data): >5.08 mg/L for nickel oxide green; >5.15 mg/L for nickel oxide black                                                                            (>3,900 mg Ni/m3) (EPSL, 2009/2010) NOAEC (inhalation, local, animal data): 3.9 mg Ni/m3(MMAD =2.9 µm) for local effects(DNEL calculation is based on 16-day repeated dose study-Dunnick et al, 1988; no acute, local effects data available)   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a079b178-62d7-4a87-8e9f-bc9aeec888dc/documents/48641d0a-c36c-418f-87b7-36f71742b355_fb0bb2a8-e167-4de5-8781-e0cd7bd9efb9.html,,,,,, "nickel(2+) disodium 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate",15708-55-1," As prooved by the studies, the toxicity of edetic acid is much lower than of nickel(2 +) salts. Sodium cations are known to be non-toxic. Thus the acute orla toxicity of EDTA-NiNa2 is determined by the nickel moiety. Regarding the molecular weight of EDTA-NiNa2 an oral LD50 value >= 300 mg/kg bw could be concluded, which leads to the category 4 classification according to the regulation 1272/2008 (CLP-Regulation). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31e98726-526f-4b1c-81c9-b9beaf91cf1f/documents/c2c61609-682b-4fe4-b1ea-55e1ec49d26c_767fc588-763e-4b93-b147-2b191b321004.html,,,,,, "nickel(2+) disodium 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate",15708-55-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31e98726-526f-4b1c-81c9-b9beaf91cf1f/documents/c2c61609-682b-4fe4-b1ea-55e1ec49d26c_767fc588-763e-4b93-b147-2b191b321004.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Nickel(2+) hydrogen citrate,18721-51-2,Oral:NOAEL = 7.02 mg/kg bw Trinickel dicitrateLOAEL = 21.1 mg/kg bw Trinickel dicitrateInhalation:NOAEC = 0.159 mg/m3 Trinickel dicitrateLOAEC = 0.368 mg/m3 Trinickel dicitrate ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef0dd7c0-0cc8-407a-866b-a20ce8b2dd7d/documents/IUC5-31010f7c-5c9f-4aec-96c7-16f349aa57a6_d8e85451-73d8-48a6-aebe-753c900b2f1a.html,,,,,, Nickel(2+) hydrogen citrate,18721-51-2,Oral:LD50 cut-off = 370 mg/kg bw Trinickel dicitrateDermal:LD50 > 1480 mg/kg bw Trinickel dicitrate ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef0dd7c0-0cc8-407a-866b-a20ce8b2dd7d/documents/IUC5-1ac529cf-5bff-4587-973d-33eee84b9042_d8e85451-73d8-48a6-aebe-753c900b2f1a.html,,,,,, Nickel(2+) propionate,3349-08-4,"read across to nickel sulfate hexahydrate (CAS 101-97-0): oral NOAEL 10 mg/kg bw/d (OECD 451) read across to nickel sulfate hexahydrate (CAS 101-97-0): inhal NOAEC 0.125 mg/m3 air (OECD 453) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Guideline and GLP study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline and GLP study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline and GLP study ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f82a9ade-a23f-496c-b9da-1cafea1fd3ca/documents/f5b2c9c7-2382-4290-b6be-d5c283bee52f_64beed4e-ec2c-41ab-a93c-c0be5968388b.html,,,,,, Nickel(2+) propionate,3349-08-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f82a9ade-a23f-496c-b9da-1cafea1fd3ca/documents/f5b2c9c7-2382-4290-b6be-d5c283bee52f_64beed4e-ec2c-41ab-a93c-c0be5968388b.html,Chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Nickel(2+) propionate,3349-08-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f82a9ade-a23f-496c-b9da-1cafea1fd3ca/documents/f5b2c9c7-2382-4290-b6be-d5c283bee52f_64beed4e-ec2c-41ab-a93c-c0be5968388b.html,Chronic toxicity – systemic effects,inhalation,NOAEC,0.125 mg/m3,,rat Nickel(2+) propionate,3349-08-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f82a9ade-a23f-496c-b9da-1cafea1fd3ca/documents/f5b2c9c7-2382-4290-b6be-d5c283bee52f_64beed4e-ec2c-41ab-a93c-c0be5968388b.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.125 mg/m3,adverse effect observed,rat Nickel(2+) propionate,3349-08-4,"Read across nickel acetate tetrahydrate (CAS 6018-89-9): LD50 (oral)= 550 mg/kg bw Read across nickel sulfate hexahydrate (CAS 10101-97-0): LD50 (inhal)= 2.48 mg/L Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Publication of studies conducted according to OECD Guidelines and in compliance with GLP. Sufficient for assessment. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): OECD Guideline-study. Sufficient for assessment. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f82a9ade-a23f-496c-b9da-1cafea1fd3ca/documents/IUC5-823c32a9-84a1-4e2e-80f5-97e0a11584fc_64beed4e-ec2c-41ab-a93c-c0be5968388b.html,,,,,, Nickel(2+) propionate,3349-08-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f82a9ade-a23f-496c-b9da-1cafea1fd3ca/documents/IUC5-823c32a9-84a1-4e2e-80f5-97e0a11584fc_64beed4e-ec2c-41ab-a93c-c0be5968388b.html,,oral,LD50,550 mg/kg bw,adverse effect observed, Nickel(2+) propionate,3349-08-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f82a9ade-a23f-496c-b9da-1cafea1fd3ca/documents/IUC5-823c32a9-84a1-4e2e-80f5-97e0a11584fc_64beed4e-ec2c-41ab-a93c-c0be5968388b.html,,inhalation,LC50,2.48 mg/L,adverse effect observed, Nicotine dihydrogen ditartrate,65-31-6," Repeated dose toxicity: Oral Combined repeated dose & carcinogenicity study was performed to determine the toxic nature of the test chemical. The study was performed using 25 female Wistar Han rats per dose for 4 weeks. The test chemical was mixed with drinking water and used at dose level of 0 or 14.8 mg/Kg/day. During the study period, the treated animals were observed clinical signs, mortality, changes in body weight, food and water consumption. The animals were also subjected to gross pathology and histopathology. No adverse clinical signs and no mortality were shown by the treated animals. Rats treated with nicotine showed significantly (p ≤ 0.05) decreased body weight after week 1 and continuing until sacrifice. At sacrifice there was an 8.7% decrease in body weight gain in rats. Nicotine treatment caused no difference in food consumption but a significant (p ≤ 0.05) decrease in water consumption was noted in the treated rats. There was no change in relative weights of urinary bladders, but the relative weight of kidneys in the nicotine-treated group was significantly increased compared to respective control groups in both rats. Mild simple hyperplasia of the urinary bladder epithelium was observed in 7 of 10 rats with nicotine treatment. Kidney tissue from treated animals was normal histopathologically, including no evidence of kidney pelvis urothelial hyperplasia.Nicotine-treated rats showed a greater mean BrdU labeling index compared to untreated rats, but the increase was not statistically significant. The bladder from nicotine-treated rats showed greater numbers of Class III changes (9/10) when examined by SEM, suggesting localized exfoliating changes induced by nicotine treatment. Based on the observations made, the Low observed adverse effect level (LOAEL) for is considered to be 14.8 mg/Kg/day using female Wistar Han rats for 4 weeks. Repeated inhalation study: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance Nicotine dihydrogen ditartrate (65-31-6) which is reported as 9.26E-22 mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical Nicotine dihydrogen ditartrate is highly unlikely. Therefore this study is considered for waiver. Repeated dermal study; The acute toxicity value for Nicotine dihydrogen ditartrate (65-31-6) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that Nicotine dihydrogen ditartrate shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that Nicotine dihydrogen tartrate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01e66550-9f33-49eb-b43f-ae12ea3c7587/documents/96741cef-7798-4fcd-bd23-79f056d93ffd_10e53110-f779-44d0-921d-514b8a617c24.html,,,,,, Nicotine dihydrogen ditartrate,65-31-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01e66550-9f33-49eb-b43f-ae12ea3c7587/documents/96741cef-7798-4fcd-bd23-79f056d93ffd_10e53110-f779-44d0-921d-514b8a617c24.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,14.8 mg/kg bw/day,,rat Nicotine dihydrogen ditartrate,65-31-6," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is 65 mg/kg bw. The study concluded that the LD50 value is between 50-300 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 3” for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to very low vapour pressure of the test chemical, which is reported to be 1.235E-19 Pa (9.26E-22 mm Hg) at 25 °C and particle size of the test chemical which is determined to be in the range of 147 micron to 52 micron and which is much larger size range compared to the inhalable particulate matter. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The LD50 value is >5000 mg/kg bw. The study concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01e66550-9f33-49eb-b43f-ae12ea3c7587/documents/2c62549b-b36e-402f-895e-f066457345a5_10e53110-f779-44d0-921d-514b8a617c24.html,,,,,, Nicotine dihydrogen ditartrate,65-31-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01e66550-9f33-49eb-b43f-ae12ea3c7587/documents/2c62549b-b36e-402f-895e-f066457345a5_10e53110-f779-44d0-921d-514b8a617c24.html,,oral,LD50,65 mg/kg bw,adverse effect observed, Nicotine dihydrogen ditartrate,65-31-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01e66550-9f33-49eb-b43f-ae12ea3c7587/documents/2c62549b-b36e-402f-895e-f066457345a5_10e53110-f779-44d0-921d-514b8a617c24.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Nicotine sulphate,65-30-5," Acute toxicity: Oral Acute oral toxicity study of the test chemical was conducted in rats at the dose concentration of 50 mg/kg bw. 50% mortality was observed. Hence, LD50 value was considered to be 50 mg/kg bw, when rats were treated with the test chemical via oral route. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf080010-fca2-4032-86a2-5051ae156a31/documents/63e8367a-6aa2-4764-a122-4bba32277103_257605a2-14e4-490a-acc5-19e054db035f.html,,,,,, Nicotine sulphate,65-30-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf080010-fca2-4032-86a2-5051ae156a31/documents/63e8367a-6aa2-4764-a122-4bba32277103_257605a2-14e4-490a-acc5-19e054db035f.html,,oral,LD50,50 mg/kg bw,adverse effect observed, Nicotinonitrile,100-54-9,The acute oral LD50 in rats is between 1100 and 1450 mg/kg bw and the acute dermal LD50 in rabbits is mg/kg bw.approximately 3000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87b8b980-cf4e-4f00-b630-80e6f096e10c/documents/IUC5-9df46180-efaf-4965-a9f0-8243eb311958_8dafc2b5-aea2-43d3-842b-4dd779ee091a.html,,,,,, Nicotinonitrile,100-54-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87b8b980-cf4e-4f00-b630-80e6f096e10c/documents/IUC5-9df46180-efaf-4965-a9f0-8243eb311958_8dafc2b5-aea2-43d3-842b-4dd779ee091a.html,,oral,LD50,"1,100 mg/kg bw",, Nicotinonitrile,100-54-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/87b8b980-cf4e-4f00-b630-80e6f096e10c/documents/IUC5-9df46180-efaf-4965-a9f0-8243eb311958_8dafc2b5-aea2-43d3-842b-4dd779ee091a.html,,dermal,LD50,"3,000 mg/kg bw",, Niobium carbide,12069-94-2,A GLP guideline study according to OECD 422 was conducted. No adverse effects were observed after oral administration of the read across partner niobium pentachloride in male and female Wistar rats at the highest tested dose of 1000 mg/kg bw/day. The NOAEL is 1000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7dc2fda-ab30-44ad-82eb-0dc8ae8950e8/documents/IUC5-97c01da6-4a73-43fc-b0ed-ec485f58c486_2c067c2a-6fb0-4e1d-85f4-e2bf54ea9b31.html,,,,,, Niobium carbide,12069-94-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7dc2fda-ab30-44ad-82eb-0dc8ae8950e8/documents/IUC5-97c01da6-4a73-43fc-b0ed-ec485f58c486_2c067c2a-6fb0-4e1d-85f4-e2bf54ea9b31.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Niobium carbide,12069-94-2,No substance specific data for acute toxicity of niobium carbide is available. For the read across partner niobium oxide acute toxicity data is available for the inhalation and oral route. For both routes no mortality has been reported. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7dc2fda-ab30-44ad-82eb-0dc8ae8950e8/documents/IUC5-b6275302-6b7f-4f81-95b4-acf9a98681e4_2c067c2a-6fb0-4e1d-85f4-e2bf54ea9b31.html,,,,,, Niobium carbide,12069-94-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7dc2fda-ab30-44ad-82eb-0dc8ae8950e8/documents/IUC5-b6275302-6b7f-4f81-95b4-acf9a98681e4_2c067c2a-6fb0-4e1d-85f4-e2bf54ea9b31.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Niobium carbide,12069-94-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7dc2fda-ab30-44ad-82eb-0dc8ae8950e8/documents/IUC5-b6275302-6b7f-4f81-95b4-acf9a98681e4_2c067c2a-6fb0-4e1d-85f4-e2bf54ea9b31.html,,inhalation,LC50,"5,450 mg/m3",no adverse effect observed, Niobium dioxide,12034-59-2," A guideline study according to OECD 422 was conducted. No adverse effects were observed after oral administration of the source substance Niobium pentachloride in male and female Wistar rats at the highest tested dose of 1000 mg/kg bw/day. Based on the results, the NOAEL can be considered to be 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f90a60c-e4da-4a81-85f2-35a715b67560/documents/8d81b5e8-57de-4879-b9d3-47a66fd6fdeb_de60feec-8529-4931-b12a-fe0e0ce96fcc.html,,,,,, Niobium dioxide,12034-59-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f90a60c-e4da-4a81-85f2-35a715b67560/documents/8d81b5e8-57de-4879-b9d3-47a66fd6fdeb_de60feec-8529-4931-b12a-fe0e0ce96fcc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Niobium dioxide,12034-59-2," No data is available for acute toxicity with the target substance. Thus, available data from niobium pentoxide and niobium oxide (source substances) are used to assess the acute toxicity potential of niobium dioxide. In an acute oral toxicity study (OECD 423) with niobium oxide no mortality has been reported at the limit dose of 2000 mg/kg bw. Thus, the oral LD50 can be considered to be greater than 2000 mg/kg bw. In an acute inhalation toxicity study according to OECD Guideline 403, groups of young adult Sprague-Dawley rats (5/sex) were exposed via the inhalation route to niobium pentoxide (source substance) as aerosol in air for 4 hours nose only at a concentration of 5.45 mg/L. Animals then were observed for 14 days. No death occurred. Based on the results a LC50 of greater than 5.45 mg/L can be considered for both sexes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f90a60c-e4da-4a81-85f2-35a715b67560/documents/bc1ffca0-7603-4e5c-a7a6-ca210ff16d22_de60feec-8529-4931-b12a-fe0e0ce96fcc.html,,,,,, Niobium dioxide,12034-59-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f90a60c-e4da-4a81-85f2-35a715b67560/documents/bc1ffca0-7603-4e5c-a7a6-ca210ff16d22_de60feec-8529-4931-b12a-fe0e0ce96fcc.html,,inhalation,LC50,"5,450 mg/m3",no adverse effect observed, Niobium hydride,13981-86-7," Repeated Dose Toxicity - Oral Route (Doomen-van den Hoven, 2021) Under the conditions of the study, the NOAEL for the test material was > 1 000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2ee9dd9-6b7f-4bab-a625-c4456d7d7549/documents/6608e27d-6bef-42f0-9b7b-e7395f06d789_4a6d357d-33c1-4e8b-9a74-4a6acf50d9ff.html,,,,,, Niobium hydride,13981-86-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2ee9dd9-6b7f-4bab-a625-c4456d7d7549/documents/6608e27d-6bef-42f0-9b7b-e7395f06d789_4a6d357d-33c1-4e8b-9a74-4a6acf50d9ff.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Niobium hydride,13981-86-7," Acute toxicity: Oral. van Sas (2018) Under the conditions of this study, the oral LD50 value of the test material in Wistar rats was established to exceed 2 000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2ee9dd9-6b7f-4bab-a625-c4456d7d7549/documents/47f184ec-7bed-4986-a5a7-bf055aed9aa6_4a6d357d-33c1-4e8b-9a74-4a6acf50d9ff.html,,,,,, Niobium hydride,13981-86-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2ee9dd9-6b7f-4bab-a625-c4456d7d7549/documents/47f184ec-7bed-4986-a5a7-bf055aed9aa6_4a6d357d-33c1-4e8b-9a74-4a6acf50d9ff.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Niobium oxide,12034-57-0," A guideline study according to OECD 422 was conducted. No adverse effects were observed after oral administration of the source substance niobium pentachloride in male and female Wistar rats at the highest tested dose of 1000 mg/kg bw/day. Based on the results, the NOAEL can be considered to be 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc814614-087b-4d74-9fc2-98cf9d4eb82c/documents/a17e288a-52ff-4e45-b57c-088dae7acddd_5520753d-e790-4248-845b-bb8b35f3c612.html,,,,,, Niobium oxide,12034-57-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc814614-087b-4d74-9fc2-98cf9d4eb82c/documents/a17e288a-52ff-4e45-b57c-088dae7acddd_5520753d-e790-4248-845b-bb8b35f3c612.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Niobium oxide,12034-57-0," In an acute oral toxicity study (OECD 423) with niobium oxide (target substance) no mortality has been reported at the limit dose of 2000 mg/kg bw. Thus, the oral LD50 can be considered to be greater than 2000 mg/kg bw. In an acute inhalation toxicity study according to OECD Guideline 403, groups of young adult Sprague-Dawley rats (5/sex) were exposed via the inhalation route to niobium pentoxide (source substance) as aerosol in air for 4 hours nose only at a concentration of 5.45 mg/L. Animals then were observed for 14 days. No death occurred. Based on the results a LC50 of greater than 5.45 mg/L can be considered for both sexes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc814614-087b-4d74-9fc2-98cf9d4eb82c/documents/29aacdc8-eb62-4bfa-80b9-5a4e9f8ec814_5520753d-e790-4248-845b-bb8b35f3c612.html,,,,,, Niobium oxide,12034-57-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc814614-087b-4d74-9fc2-98cf9d4eb82c/documents/29aacdc8-eb62-4bfa-80b9-5a4e9f8ec814_5520753d-e790-4248-845b-bb8b35f3c612.html,,inhalation,LC50,"5,450 mg/m3",no adverse effect observed, Niobium pentachloride,10026-12-7,A GLP guideline study according to OECD 422 was conducted. No adverse effects were observed after oral administration of niobium pentachloride in male and female Wistar rats at the highest tested dose of 1000 mg/kg bw/day. The NOAEL is 1000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34c2a155-5297-4b7e-a69a-72fc8ca970dd/documents/IUC5-e3265040-b45c-4970-8e54-1ef190599d25_b17fbf0f-be5c-4865-bdf9-5a59d7e17ba9.html,,,,,, Niobium pentachloride,10026-12-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34c2a155-5297-4b7e-a69a-72fc8ca970dd/documents/IUC5-e3265040-b45c-4970-8e54-1ef190599d25_b17fbf0f-be5c-4865-bdf9-5a59d7e17ba9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Niobium pentachloride,10026-12-7,"For the target substance niobium pentachloride acute toxicity data is available for the oral route from two publications. Zhilova, 1966 published LD50 values for the rat (1400 mg/kg bw) and mouse (829 mg/kg bw). Haley, 1962 determined the oral LD50 in male CF1 mice with 940 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34c2a155-5297-4b7e-a69a-72fc8ca970dd/documents/IUC5-65abfff7-2a65-41c6-a5e6-b87001b7b753_b17fbf0f-be5c-4865-bdf9-5a59d7e17ba9.html,,,,,, Niobium pentachloride,10026-12-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34c2a155-5297-4b7e-a69a-72fc8ca970dd/documents/IUC5-65abfff7-2a65-41c6-a5e6-b87001b7b753_b17fbf0f-be5c-4865-bdf9-5a59d7e17ba9.html,,oral,LD50,829 mg/kg bw,adverse effect observed, N-isopropylhydroxylamine,5080-22-8," The NOAEL for N-isopropylhydroxylamine (IPHA) in a 90-day oral gavage study was considered to be 20 mg/kg, based on decreased body weight and signs of anaemia observed at 100 and 500 mg/kg bw. These effects were considered to be treatment-related. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09d6a88d-d3a2-47e2-b967-dc5a4acb940a/documents/IUC5-18523f30-4af7-4ffe-872d-1d1a47801056_3989c11d-cd47-4707-820a-ad53ebc45289.html,,,,,, N-isopropylhydroxylamine,5080-22-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/09d6a88d-d3a2-47e2-b967-dc5a4acb940a/documents/IUC5-18523f30-4af7-4ffe-872d-1d1a47801056_3989c11d-cd47-4707-820a-ad53ebc45289.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat N-isopropylhydroxylamine,5080-22-8,The acute toxicity of N-Isopropylhydroxylamine was examined via the oral and intraperitoneal route. The acute oral LD50 of N-Isopropylhydroxylamine following administration by gavage to male and female Sprague-Dawley rats was examined. The LD50 for male rats was calculated to be 2356 mg/kg body weight with a 95% confidence interval of 1887 to 2825 mg/kg. The LD50 for females was calculated to be 1942 mg/kg with a 95% confidence interval of 1569 to 2315 mg/kg and the combined response was calculated to be 2189 mg/kg with a 95% confidence interval of 1871 to 2507 mg/kg. The acute intraperitoneal LD50 of N-Isopropylhydroxylamine in ICR mice was examined. Animals were dosed with the test article and the survivors were euthanatized three days later. Based upon the mortality data from this study the LD50 was calculated for the males and females combined to be 1605 mg/kg (95% confidence limits could not be calculated). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09d6a88d-d3a2-47e2-b967-dc5a4acb940a/documents/IUC5-6f3f0c35-d06d-4fdd-9157-17bdb6563991_3989c11d-cd47-4707-820a-ad53ebc45289.html,,,,,, N-isopropylhydroxylamine,5080-22-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09d6a88d-d3a2-47e2-b967-dc5a4acb940a/documents/IUC5-6f3f0c35-d06d-4fdd-9157-17bdb6563991_3989c11d-cd47-4707-820a-ad53ebc45289.html,,oral,LD50,"2,189 mg/kg bw",adverse effect observed, N-isopropylhydroxylamine,5080-22-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/09d6a88d-d3a2-47e2-b967-dc5a4acb940a/documents/IUC5-6f3f0c35-d06d-4fdd-9157-17bdb6563991_3989c11d-cd47-4707-820a-ad53ebc45289.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, N-isopropylmethacrylamide,13749-61-6,"The oral administration of N-Isopropylmethacrylamide (NIPMAA) to rats by gavage, at dose levels of 100, 190 and 350 mg/kg bw/day A.I., resulted in treatment-related finding in animals of either sex from all treatment groups. A ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity has therefore not been established. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): The subchronic inhalation toxicity study in the rat, on a read-across substance (methacrylamide) is acceptable and satisfies the guideline requirement for a subchronic inhalation study OECD 413 in the rat. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study has been conducted according to OECD Guideline 422 and GLP and is adequately reported. The study has been assigned a reliability 1. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5cfef74d-1a15-45be-9975-87cfdb7c7439/documents/ae3424fc-542d-4a0d-a975-106ea80c1bca_1c411038-e212-4ef9-bc96-90a5d7f206d2.html,,,,,, N-isopropylmethacrylamide,13749-61-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5cfef74d-1a15-45be-9975-87cfdb7c7439/documents/ae3424fc-542d-4a0d-a975-106ea80c1bca_1c411038-e212-4ef9-bc96-90a5d7f206d2.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat N-isopropylmethacrylamide,13749-61-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5cfef74d-1a15-45be-9975-87cfdb7c7439/documents/ae3424fc-542d-4a0d-a975-106ea80c1bca_1c411038-e212-4ef9-bc96-90a5d7f206d2.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,62.5 mg/m3,,rat N-isopropylmethacrylamide,13749-61-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5cfef74d-1a15-45be-9975-87cfdb7c7439/documents/ae3424fc-542d-4a0d-a975-106ea80c1bca_1c411038-e212-4ef9-bc96-90a5d7f206d2.html,Repeated dose toxicity – local effects,inhalation,NOAEC,10 mg/m3,adverse effect observed,rat N-isopropylmethacrylamide,13749-61-6,The acute oral median lethal dose (LD50) of the test material in the female Sprague-Dawley CD strain rat was estimated to be greater than 2000 mg/kg bodyweight.The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2191 mg/kg bodyweight (equivalent to 2000 mg active ingredient/kg bodyweight). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cfef74d-1a15-45be-9975-87cfdb7c7439/documents/82e21030-ee83-4719-8671-d6f3772af71a_1c411038-e212-4ef9-bc96-90a5d7f206d2.html,,,,,, N-isopropylmethacrylamide,13749-61-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cfef74d-1a15-45be-9975-87cfdb7c7439/documents/82e21030-ee83-4719-8671-d6f3772af71a_1c411038-e212-4ef9-bc96-90a5d7f206d2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, N-isopropylmethacrylamide,13749-61-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cfef74d-1a15-45be-9975-87cfdb7c7439/documents/82e21030-ee83-4719-8671-d6f3772af71a_1c411038-e212-4ef9-bc96-90a5d7f206d2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, N-isopropyl-N'-phenyl-p-phenylenediamine,101-72-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c85593b-a076-46cf-81ce-834327d45eaf/documents/424171f9-3415-4c72-b7e5-8df06137106c_8c19eea9-b5b7-4f3c-a8de-ecbafb939015.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,13.5 mg/kg bw/day,, N-isopropyl-N'-phenyl-p-phenylenediamine,101-72-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c85593b-a076-46cf-81ce-834327d45eaf/documents/86c2d929-c841-4db8-a354-6ea3ddcbecd6_8c19eea9-b5b7-4f3c-a8de-ecbafb939015.html,,oral,LD50,522 mg/kg bw,, N-isopropyl-N'-phenyl-p-phenylenediamine,101-72-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c85593b-a076-46cf-81ce-834327d45eaf/documents/86c2d929-c841-4db8-a354-6ea3ddcbecd6_8c19eea9-b5b7-4f3c-a8de-ecbafb939015.html,,dermal,LD50,"7,940 mg/kg bw",, Nitrapyrin,1929-82-4," ORAL NOEL = 5 mg/kg bw/day (males), NOEL = 20 mg/kg bw/day (females); 2-years (rat); EPA OPP 83-1, EPA OPP 83-2, Szabo et al. (1989) NOEL = 3 mg/kg bw/day (male/female); 1-year (dog); EPA OPP 83-1; Barna-Lloyd et al. (1989) NOEL = 27 mg/kg bw/day (male/female); 90-day (rat); similar to OECD 408; Anon. (1962)   INHALATION No study available. DERMAL NOEL = 1000 mg/kg bw/day, 21 day (rabbit); OECD 410, EPA OPP 82-2, MAFF, EEC Directive 67/548/EEC; Cosse et al. (1992) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86ff5ebc-e51a-420a-bf61-e21488b99e65/documents/4770e999-49f1-4064-87be-ee2646b12fbf_8d3e7bb9-2c15-4b4b-a76b-d734a9ff56ba.html,,,,,, Nitrapyrin,1929-82-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86ff5ebc-e51a-420a-bf61-e21488b99e65/documents/4770e999-49f1-4064-87be-ee2646b12fbf_8d3e7bb9-2c15-4b4b-a76b-d734a9ff56ba.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rabbit Nitrapyrin,1929-82-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86ff5ebc-e51a-420a-bf61-e21488b99e65/documents/4770e999-49f1-4064-87be-ee2646b12fbf_8d3e7bb9-2c15-4b4b-a76b-d734a9ff56ba.html,Chronic toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat Nitrapyrin,1929-82-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86ff5ebc-e51a-420a-bf61-e21488b99e65/documents/4770e999-49f1-4064-87be-ee2646b12fbf_8d3e7bb9-2c15-4b4b-a76b-d734a9ff56ba.html,Repeated dose toxicity – local effects,dermal,NOAEL,2.2 mg/cm2,adverse effect observed,rabbit Nitrapyrin,1929-82-4," ORAL LD50 = 1072 mg/kg (rat, male); LD50 = 1231 mg/kg (rat, female); method similar to OECD 401; Norris (1971) LD50 >5000 mg test material formulation/kg; >895 mg registered substance/kg (rat, female); substance present in test material formulation at 17.9 % w/w; OECD 425, EPA OPPTS 870.1100; Lowe (2007)   INHALATION LC50 >3.51 mg test material/L air; >0.63 mg registered substance/L air (rat, male/female); substance present in test material formulation at 17.9 % w/w; EPA OPPTS 870.1300, OECD 403, EU Method B.4 and the JMAFF guideline for acute inhalation toxicity; Krieger & Radtke (2007) DERMAL LD50 > 2000 mg/kg (rabbit, male/female), method analogous to OECD 402, Carreon et al. (1986) LD50 = 2830 mg/kg (rabbit, male/female), method similar to OECD 402, Norris (1971) LD50 > 5000 mg test material/kg; > 895 mg registered substance/kg (rat, male/female), substance present in test material formulation at 17.9% w/w, EPA OPTS 870.1200, OECD 402, EU Method B.3 and JMAFF 12 -Nouan-8147, Lowe (2007) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86ff5ebc-e51a-420a-bf61-e21488b99e65/documents/a32d5a7f-9b8d-4d20-88ec-7af7e5e5b042_8d3e7bb9-2c15-4b4b-a76b-d734a9ff56ba.html,,,,,, Nitrapyrin,1929-82-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86ff5ebc-e51a-420a-bf61-e21488b99e65/documents/a32d5a7f-9b8d-4d20-88ec-7af7e5e5b042_8d3e7bb9-2c15-4b4b-a76b-d734a9ff56ba.html,,oral,LD50,"1,066 mg/kg bw",adverse effect observed, Nitrapyrin,1929-82-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86ff5ebc-e51a-420a-bf61-e21488b99e65/documents/a32d5a7f-9b8d-4d20-88ec-7af7e5e5b042_8d3e7bb9-2c15-4b4b-a76b-d734a9ff56ba.html,,dermal,LD50,"2,830 mg/kg bw",no adverse effect observed, Nitric acid,7697-37-2,"Repeated dose toxicity - oral: A Combined Repeated Dose Toxicity Study With the Reproduction/Developmental Toxicity Screening Test (oral gavage in rats) on potassium nitrate from Product Safety Laboratories, 2002 provide a NOAEL of 1500 mg/kg/day Repeated dose toxicity - inhalation: A repeated dose inhalation toxicity study for nitrogen dioxide gas reported a NOAEC of ≥ 2.15 ppm (4.11 mg/m^3).Repeated dose toxicity - dermal: No data ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7aaa697a-9dea-48dc-9873-148743cbeade/documents/IUC5-beeea119-54ad-42f9-be0a-2bc025a27093_e0cbdce9-fc68-44f1-9e39-4df7ad2f88f0.html,,,,,, Nitric acid,7697-37-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7aaa697a-9dea-48dc-9873-148743cbeade/documents/IUC5-beeea119-54ad-42f9-be0a-2bc025a27093_e0cbdce9-fc68-44f1-9e39-4df7ad2f88f0.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,4.11 mg/m3,,rat Nitric acid,7697-37-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7aaa697a-9dea-48dc-9873-148743cbeade/documents/IUC5-beeea119-54ad-42f9-be0a-2bc025a27093_e0cbdce9-fc68-44f1-9e39-4df7ad2f88f0.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4.11 mg/m3,no adverse effect observed,rat Nitric acid,7697-37-2,"Acute toxicity oral : No data (study waived based on corrosivity of the test substance)Acute toxicity inhalation: In A GLP-compliant study conducted according to OECD Guideline 403 with an aqueous solution of 70% nitric acid, a vapor atmosphere containing ca. 0.8% liquid aerosol was tested in rats via nose-only inhalation. The LC50 was found to be >2.65 mg/L.Acute toxicity dermal: No data (study waived based on corrosivity of the test substance) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Two reliable studies are available. A technical report is available to account for missing information in one of the two reports. Furthermore, three disregarded studies are available (Klimisch 3). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7aaa697a-9dea-48dc-9873-148743cbeade/documents/IUC5-117dee5a-b1fe-4ad6-9c57-42100aa05958_e0cbdce9-fc68-44f1-9e39-4df7ad2f88f0.html,,,,,, Nitric acid,7697-37-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7aaa697a-9dea-48dc-9873-148743cbeade/documents/IUC5-117dee5a-b1fe-4ad6-9c57-42100aa05958_e0cbdce9-fc68-44f1-9e39-4df7ad2f88f0.html,,inhalation,LC50,"2,650 mg/m3",adverse effect observed, "Nitric acid, ammonium calcium salt",15245-12-2,"A reliable 28-day oral OECD 422 study has been performed in rats (5 rats/sex/dose) via gavage, containing 50, 750 or 1500 mg/kg bw/day potassium nitrate. There were no treatment-related deaths and no signs of overt clinical toxicity. There were no effects on body weight, food consumption, or food efficiency. Functional observational battery (FOB) and motor activity tests identified no treatment-related changes in behavior, function, or motor activity. No treatment-related histopathological changes were reported. Therefore, it was concluded that the NOAEL is ≥ 1500 mg KNO3/kg bw/day, ≥920 mg nitrate/kg bw/day (or higher, highest dose tested). A reliable 28 -day oral OECD 407, EU B.7 guideline study has been performed in rats (5 rats/sex/dose) via gavage, containing 50, 150 or 1000 mg/kg bw/day Nitcal-K (potassium pentacalcium nitrate decahydrate). There were no treatment-related deaths and no signs of overt clinical toxicity. There were no effects on body weight, food consumption, or food efficiency. Functional observational battery (FOB) and motor activity tests identified no treatment-related changes in behavior, function, or motor activity. In haematology high-dose males reticulocytes and red cell distribution width were slightly increased; in high-dose females red blood cell count and haematocrit was slightly decreased. Reviewer: these changes are not consistent between males/females, are very slight, and three out of four appeared to be in the historical control range from this strain (based on NOTOX historical data) and this kind of study. Therefore, these are not considered adverse. At gross pathology a thickened limiting ridge and/or foci in glandular mucosa in 2 and 3 high-dose males and females, respectively, were noted. This is a local effect and reversible. At histopathology some non-neoplastic effects were observed: hyperplasia/hyperkeratosis of the limiting ridge of the stomach in 4 and 3 high dose males and females, respectively. This is considered a local effect and reversible according to the reviewer. In addition an increased severity of haemopoietic foci (erythroid) in the spleen at high dose was noted. Reviewer: The effect in the spleen is limited to one male and one female with a moderate severity at the high dose. However, this is a symptom expected in young animals in such a study, in addition it is considered a reversible effect. This is based on expertise of an experienced pathologist. Therefore, it was concluded that the NOAELsystemic is ≥1000 mg Nitcal-K/kg bw/day, ≥56 mg nitrate/kg bw/day(highest dose tested).  In conclusion, no systemic adverse effects were observed up to and including the highest dose tested in two 28-day oral toxicity studies. The data from the 104-week carcinogenicity study in rats (Maekawa et al., 1982) do not indicate adverse toxic effects / carcinogenic potential of sodium nitrate. The Maekawa et al. (1982) study was used by SCF and EFSA for the derivation of the ADI.  F344 rats (50 animals per sex per group, 8 weeks old) were given 0%, 2.5% and 5% sodium nitrate in the diet ad libitum (equivalent to 0, 1250 and 2500 mg/kg bw per day, or 0, 910, or 1820 mg/kg bw per day expressed as nitrate ion) in a 2-year feeding study (Maekawa et al., 1982). Rats in the control group were given a basic diet without nitrate ad libitum. Treatment was stopped at week 104 and the rats were given a basic diet until week 123 to account for the number of survivors in at least one group of either sex that was less than 20%. Diet and water consumption was constant in all groups throughout the study. The growth curves showed that the mean body weight of male fats did not differ more than 10%, whereas female rats differed by more than 10% in the high-dose group after week 60. However, no statistically significant differences were reported for this parameter. Treatment with sodium nitrate did not have statistically significant effect on survival rates, although male rats in the 5% group (equivalent to 2500 mg sodium nitrate/kg bw per day, 1820 mg nitrate ion/kg bw per day) had 10% higher cumulative mortality compared to the 2.5% group (equivalent to 1250 mg sodium nitrate/kg bw per day, 910 mg nitrate ion/kg bw per day). At the end of the study (2 years), both male and female control groups showed a statistically significant lower number of survivors compared to both treatment groups. However, the mean survival time did not differ significantly among all groups. The incidence of tumours in all groups, including controls, was high. For example, the percentage of animals showing tumours in the control groups was reported to reach 94% and 92% for male and female rats, respectively. In male rats from the 2.5% sodium nitrate group (equivalent to 1250 mg/kg bw per day, 910 nitrate ion/kg bw per day), tumour incidence was reported to be 100%, whereas, in male rats from the 5% dose group (equivalent to 2500 mg/kg bw per day, 1820 mg nitrate ion/kg bw per day), the incidence was 96%. All other groups showed lower absolute tumour incidences than controls. The most commonly observed tumour in males was in the testes (interstitial cell) followed by the mammary gland, adrenal gland and liver. Tumours of the mammary gland, pituitary gland, uterus and adrenal gland were the most commonly observed tumours in females. Overall, there was no statistically significant difference of any specific tumour. The time of appearance of the first background tumour was not affected in any treatment group. Only the incidences of tumours of the haematopoietic organs were reported to be statistically significantly lower in the treated groups compared to controls, especially concerning mononuclear cell leukaemia. In conclusion, no adverse effects were observed up to and including the highest dose tested. Sodium nitrate did not have carcinogenic activity in F344 rats when administered continuously for 2 years. In conclusion, no carcinogenic effects were observed and the NOAEL for adverse toxic effects is ≥2500 mg sodium nitrate/kg bw/day, ≥1820 mg nitrate/kg bw/day (highest dose tested). Expert statement: Based on the existing data, read across and current ADI values no relevant toxicity after sub-chronic exposure is expected. Overall, generation of additional sub-chronic oral toxicity data is considered not scientifically justified and the sub-chronic oral toxicity study (90-days) thus waived. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf0c24ca-a87f-4012-9d41-96436998429e/documents/e091d179-cc37-4f8f-924d-f1e063b890e3_d8c3c6a6-e727-4e51-9769-7862b8144998.html,,,,,, "Nitric acid, ammonium calcium salt",15245-12-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf0c24ca-a87f-4012-9d41-96436998429e/documents/e091d179-cc37-4f8f-924d-f1e063b890e3_d8c3c6a6-e727-4e51-9769-7862b8144998.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,920 mg/kg bw/day,,rat "Nitric acid, ammonium calcium salt",15245-12-2,"Based on a reliable acute oral toxicity study (OECD 423) the LD50 is determined to be >300 mg/kg bw and <2000 mg/kg bw for CN-Nitcal (LD50 cut-off value 500 mg/kgbw). In addition,  no acute dermal toxicity study with the substance itself is present. However, a reliable acute dermal toxicity study with Nitcal-K showed an LD50>2000 mg/kg bw.  An acute inhalation study is not considered necessary as the vapour pressure is assumed to be very low and the particle size of CN-Nitcal is very high with an MMAD > 2000 micrometer, which shows that inhalation is an very unlikely route of exposure. The read-across rationale can be found in the document attached to the target record. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf0c24ca-a87f-4012-9d41-96436998429e/documents/89951d45-938d-4c9c-bfbb-3727bab642c8_d8c3c6a6-e727-4e51-9769-7862b8144998.html,,,,,, "Nitric acid, ammonium calcium salt",15245-12-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf0c24ca-a87f-4012-9d41-96436998429e/documents/89951d45-938d-4c9c-bfbb-3727bab642c8_d8c3c6a6-e727-4e51-9769-7862b8144998.html,,oral,LD50,ca.500 mg/kg bw,adverse effect observed, "Nitric acid, ammonium calcium salt",15245-12-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf0c24ca-a87f-4012-9d41-96436998429e/documents/89951d45-938d-4c9c-bfbb-3727bab642c8_d8c3c6a6-e727-4e51-9769-7862b8144998.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Nitric acid, reaction products with cyclododecanol and cyclododecanone, by-products from, high-boiling fraction",72162-23-3,A key read-across study with dodecanedioic acid (CAS# 693-23-2) demonstrated that Corfree® M1 (CASRN: 72162-23-2) is not expected to show any adverse effects after repeated dose. A 90-day oral gavage repeated dose study in rats showed no adverse effects up to dose levels of 1800 mg/kg bw/d.A 14-day oral gavage repeated dose study in rats showed no adverse effects up to dose levels of 2400 mg/kg bw/d.A 50-day oral combined repeated dose and reproductive toxicity study in rats showed no adverse effects up to dose levels of 1000 mg/kg bw/d. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/90b2abb8-cfcd-4781-a787-18f9d2bbe065/documents/IUC5-fae769a6-7866-41b3-b2d7-60a4981413d5_d8c70840-b701-4202-a968-c5de47de0f41.html,,,,,, "Nitric acid, reaction products with cyclododecanol and cyclododecanone, by-products from, high-boiling fraction",72162-23-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/90b2abb8-cfcd-4781-a787-18f9d2bbe065/documents/IUC5-fae769a6-7866-41b3-b2d7-60a4981413d5_d8c70840-b701-4202-a968-c5de47de0f41.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,800 mg/kg bw/day",,rat "Nitric acid, reaction products with cyclododecanol and cyclododecanone, by-products from, high-boiling fraction",72162-23-3,"Experimental studies on oral and dermal acute toxicity are available. Corfree has very low toxicity upon acute exposure.Oral: LD50 (males/female rats): > 5,000 mg/kg bw Dermal: LD50 (males/ rabbits): > 6,000 mg/kg bwInhalation:LC50 (male rats/4h) : No data ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90b2abb8-cfcd-4781-a787-18f9d2bbe065/documents/IUC5-c5880c4b-a0d2-4426-8840-3f170745f754_d8c70840-b701-4202-a968-c5de47de0f41.html,,,,,, "Nitric acid, reaction products with cyclododecanol and cyclododecanone, by-products from, high-boiling fraction",72162-23-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90b2abb8-cfcd-4781-a787-18f9d2bbe065/documents/IUC5-c5880c4b-a0d2-4426-8840-3f170745f754_d8c70840-b701-4202-a968-c5de47de0f41.html,,oral,discriminating dose,"5,000 mg/kg bw",adverse effect observed, "Nitric acid, reaction products with cyclododecanol and cyclododecanone, by-products from, high-boiling fraction",72162-23-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90b2abb8-cfcd-4781-a787-18f9d2bbe065/documents/IUC5-c5880c4b-a0d2-4426-8840-3f170745f754_d8c70840-b701-4202-a968-c5de47de0f41.html,,dermal,LD50,"6,000 mg/kg bw",, Nitrile hydratase recombinant from E.coli,82391-37-5," In accordance with Annex VIII of REACH, a study to address information requirement 8.6.1 (short-term repeated dose toxicity) does not need to be conducted because relevant human exposure can be excluded in accordance with REACH Annex XI Section 3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/78671455-d0be-4f92-b46b-0c14df6e34d9/documents/9160acbe-fbc8-4862-9342-6afe6fdd148d_989f54c2-2b02-4280-9ae0-81fa860487a4.html,,,,,, Nitrile hydratase recombinant from E.coli,82391-37-5," Acute toxicity: oral key study (Nakamura, 2004): Under the conditions of this study, the test material was found to have a LD50 > 2000 mg/kg bw when it was administered orally to rats once. Acute toxicity: inhalation and dermal In accordance with Column 2 of REACH Annex VIII, acute toxicity need only be addressed in one route if there is only one route of human exposure that is likely. Information on the acute toxicity of the substance is provided for the oral route of exposure, since human exposure via the dermal and inhalation routes of exposure are not considered to be likely routes of human exposure. In vivo acute dermal and/or inhalation toxicity studies will not add any value and cannot be expected to provide valuable knowledge and are thus considered scientifically and ethically unjustified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78671455-d0be-4f92-b46b-0c14df6e34d9/documents/14f65e93-6fcf-43f4-80d0-37cef2599a2c_989f54c2-2b02-4280-9ae0-81fa860487a4.html,,,,,, Nitrile hydratase recombinant from E.coli,82391-37-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78671455-d0be-4f92-b46b-0c14df6e34d9/documents/14f65e93-6fcf-43f4-80d0-37cef2599a2c_989f54c2-2b02-4280-9ae0-81fa860487a4.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, C12-18 evennumbered alkyl nitrile,1218787-29-1,NOAEL = 50 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/362d347d-0e0e-4a3d-ba76-683ed5f63a6f/documents/fb4a4456-d523-43a8-896d-f7c0d5a727ed_8ea234a7-3941-4626-b489-b5ecf6706620.html,,,,,, C12-18 evennumbered alkyl nitrile,1218787-29-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/362d347d-0e0e-4a3d-ba76-683ed5f63a6f/documents/fb4a4456-d523-43a8-896d-f7c0d5a727ed_8ea234a7-3941-4626-b489-b5ecf6706620.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat C12-18 evennumbered alkyl nitrile,1218787-29-1,"Acute toxicity: Oral LD50 > 5,000 mg/kg for rat (LD50 limit test - no mortality) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/362d347d-0e0e-4a3d-ba76-683ed5f63a6f/documents/a3cba10d-1aa6-4ad3-b21a-dd2c45478ed3_8ea234a7-3941-4626-b489-b5ecf6706620.html,,,,,, "Nitriles, C16-18",68002-65-3,NOAEL = 50 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8293047a-5e3c-4fe2-839c-9f26a572d325/documents/IUC5-af412e41-dc6c-497b-8340-da27409319ca_4539007a-b087-4d4e-a1a6-4429db7ec40e.html,,,,,, "Nitriles, C16-18",68002-65-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8293047a-5e3c-4fe2-839c-9f26a572d325/documents/IUC5-af412e41-dc6c-497b-8340-da27409319ca_4539007a-b087-4d4e-a1a6-4429db7ec40e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Nitriles, C16-18",68002-65-3,"Acute toxicity: Oral LD50 > 5,000 mg/kg for rat (LD50 limit test - no mortality)   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8293047a-5e3c-4fe2-839c-9f26a572d325/documents/IUC5-eafc48fa-e7d0-416b-8a94-76d381d07818_4539007a-b087-4d4e-a1a6-4429db7ec40e.html,,,,,, "Nitriles, C16-18",68002-65-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8293047a-5e3c-4fe2-839c-9f26a572d325/documents/IUC5-eafc48fa-e7d0-416b-8a94-76d381d07818_4539007a-b087-4d4e-a1a6-4429db7ec40e.html,,oral,LD0,"> 5,000 mg/kg bw",no adverse effect observed, "C16-18 evennumbered, C18 unsaturated alkyl nitrile",164383-22-6,NOAEL = 50 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5e02c00-c91c-4151-a599-c2da6c77d852/documents/91211aac-78da-4328-9e60-964e49bb3370_7b776f16-9318-4412-a017-a181232bc8ec.html,,,,,, "C16-18 evennumbered, C18 unsaturated alkyl nitrile",164383-22-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5e02c00-c91c-4151-a599-c2da6c77d852/documents/91211aac-78da-4328-9e60-964e49bb3370_7b776f16-9318-4412-a017-a181232bc8ec.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "C16-18 evennumbered, C18 unsaturated alkyl nitrile",164383-22-6,"Acute toxicity: Oral LD50 > 5,000 mg/kg for rat (LD50 limit test - no mortality)   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5e02c00-c91c-4151-a599-c2da6c77d852/documents/fb9e9b67-fdad-45ec-b6d8-3ee3a498e07a_7b776f16-9318-4412-a017-a181232bc8ec.html,,,,,, Nitrilotriacetonitrile,7327-60-8,A combined 28-day oral repeated dose study and reproductive/development study in rats was available. The dose levels for this study were based on a 14-day range-finding study. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/07db94df-0402-4a8d-888d-c5f0cf082726/documents/IUC5-7c599930-7d66-48e8-a38a-61f02b571006_8d3ffb6b-5ff3-4c9d-b910-fecadb482d11.html,,,,,, Nitrilotriacetonitrile,7327-60-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/07db94df-0402-4a8d-888d-c5f0cf082726/documents/IUC5-7c599930-7d66-48e8-a38a-61f02b571006_8d3ffb6b-5ff3-4c9d-b910-fecadb482d11.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Nitrilotriacetonitrile,7327-60-8,"Several acute oral toxicity studies were available, and several types of NTAN have been tested, viz. a standard batch, a recrystallized bath and a lab washed batch. In addition, a batch was tested with unknown purity. One dermal acute toxicity was available. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/07db94df-0402-4a8d-888d-c5f0cf082726/documents/IUC5-21685578-d503-47e5-a5b8-df7aa0bcf4d3_8d3ffb6b-5ff3-4c9d-b910-fecadb482d11.html,,,,,, Nitrogen trifluoride,7783-54-2," Justification for selection of repeated dose toxicity via oral route - systemic effects endpoint: As nitrogen trifluoride is a gas, the oral route of exposure is not relevant Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint: A NOAEL was deemed to be 5 ppm (equivalent to 14.8 mg/m3) for both males and females based on the evidence of haemolytic anaemia at the LOAEL of 20 ppm. Justification for selection of repeated dose toxicity inhalation - local effects endpoint: no local effects observed Justification for selection of repeated dose toxicity dermal - systemic effects endpoint: As nitrogen trifluoride is a gas, the dermal route of exposure is not relevant Justification for selection of repeated dose toxicity dermal - local effects endpoint: As nitrogen trifluoride is a gas, the dermal route of exposure is not relevant Repeated dose toxicity: inhalation - systemic effects (target organ)cardiovascular / hematological: heart; cardiovascular / hematological: spleen; cardiovascular / hematological: other; digestive: liver ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ebffb55-1941-476a-adf9-9373ce3b34e2/documents/7fe7c01a-7bbc-4490-bce2-cf51278be4c6_f9fabac1-ed82-4585-b589-7b89a4c8135a.html,,,,,, Nitrogen trifluoride,7783-54-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ebffb55-1941-476a-adf9-9373ce3b34e2/documents/7fe7c01a-7bbc-4490-bce2-cf51278be4c6_f9fabac1-ed82-4585-b589-7b89a4c8135a.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,14.8 mg/m3,,rat Nitrogen trifluoride,7783-54-2," As NF3is a gas the oral and dermal route of exposure are not considered relevant. Of the numerous inhalation experiments conducted with NF3only one experiment meets the requirements of REACh (Deichmann & Gerade) of a 4 hour exposure. The LC50value reported here was 2000 ppm (equivalent to 5920 mg/m3) in mice; however details regarding the design of this study are lacking, with only an LC50value reported.  In the Vernotet al(1973) study, the inhalatory toxicity of NF3was determined in a number of species including the rat and mouse. The design for this consisted of a single 1 hour exposure to rats and mice exposed whole body. The 1 hour LC50values reported in this study were 6700 ppm (2264 mg/m3) and 7500 ppm 2534 mg/m3) for rats and mice, respectively. The rat value has been directly cited by the ISO 10298 International standards document for the determination of a gas or gas mixture. The inclusion of the mouse value here is compare the value obtained with the rat and the Deichmann & Gerade study.  The data reported by Vernot et alconfirms that there is little in difference in terms of the acute toxicity of NF3to mice or rats following a 1 h, whole-body exposure. Following time adjustment using Haber’s rule to a 4h LC50a value of 3350 ppm was derived for the rat (and 3750 ppm for the mouse). It is noted (by ISO 10298) that the use of Haber’s rule predicts a lower LC50value when extrapolating from 1h to a 4h LC50value. When comparing time adjusted 4h LC50valuevs.experimentally generated data for the mouse, the time adjusted value is almost 2-fold greater. However, as originally stated however, the data reported by Deichmann & Gerade is not open to scientific scrutiny as no experimental details have been found in the published literature. It is therefore deemed appropriate to use the time adjusted LC50value, which is viewed as a more conservative estimate of the toxicity. Furthermore, the rat LC50value provides further assurance as it is the lower of the two time adjusted values. Justification for selection of acute toxicity – oral endpoint As nitrogen trifluoride is a gas, the oral route of exposure is not relevant Justification for selection of acute toxicity – inhalation endpoint The only available data in the literature which complies with requirements of REACh Justification for selection of acute toxicity – dermal endpoint As nitrogen trifluoride is a gas, the dermal route of exposure is not relevant ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ebffb55-1941-476a-adf9-9373ce3b34e2/documents/e5d606fd-61ee-4aed-b8ca-77253a1bfc0e_f9fabac1-ed82-4585-b589-7b89a4c8135a.html,,,,,, Nitrogen trifluoride,7783-54-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ebffb55-1941-476a-adf9-9373ce3b34e2/documents/e5d606fd-61ee-4aed-b8ca-77253a1bfc0e_f9fabac1-ed82-4585-b589-7b89a4c8135a.html,,inhalation,LC50,"9,916 mg/m3",adverse effect observed, Nitrosodiphenylamine,86-30-6, Combined Repeated Dose Toxicity Study with the Reproduction/developmental toxicity study (OECD 422) was performed on N-nitrosodiphenylamine. Animals were exposed to the test item at least 28 days. The NOAEL for parental systemic toxicity was considered to be 50 mg/kg/day based on the microscopic findings observed at 150 mg/kg/day in the urinary bladder in males and females. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b301a97f-0338-4fde-ad72-e2fa6328dd0f/documents/0ac79bf8-f90a-43c3-a92a-3b9f4ad41888_2a475113-6962-4757-8994-f9cd0ea9d774.html,,,,,, Nitrosodiphenylamine,86-30-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b301a97f-0338-4fde-ad72-e2fa6328dd0f/documents/0ac79bf8-f90a-43c3-a92a-3b9f4ad41888_2a475113-6962-4757-8994-f9cd0ea9d774.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Nitrosodiphenylamine,86-30-6," Acute toxicity studies were performed on n-nitrosodiphenylamine by oral and dermal route. Based on the results, the LD50 for both routes are higher than 2000 mg/kg/day. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b301a97f-0338-4fde-ad72-e2fa6328dd0f/documents/6cf4733d-ecd7-4fb6-b0fe-ac16ff03d46f_2a475113-6962-4757-8994-f9cd0ea9d774.html,,,,,, Nitrosodiphenylamine,86-30-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b301a97f-0338-4fde-ad72-e2fa6328dd0f/documents/6cf4733d-ecd7-4fb6-b0fe-ac16ff03d46f_2a475113-6962-4757-8994-f9cd0ea9d774.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Nitrosodiphenylamine,86-30-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b301a97f-0338-4fde-ad72-e2fa6328dd0f/documents/6cf4733d-ecd7-4fb6-b0fe-ac16ff03d46f_2a475113-6962-4757-8994-f9cd0ea9d774.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Nitrotoluene,1321-12-6," There is no repeated dose toxicity study available for nitrotoluene (CAS 1321-12-6), but a read-across can be made from 4-nitrotoluene (CAS 99-99-0). In a 13-week feeding study with rats, similar to OECD TG 408 and compliant to GLP, 4-nitrotoluene caused hematopoiesis and hemosiderin pigment accumulation in the spleen of both sexes at all dose levels tested. Methemoglobinemia was noted at study end in the 13 week study at 10,000 ppm (male: approximately 723 mg/kg bw/day, female: approximately 680 mg/kg bw/day). At high and systemically toxic exposure levels, testicular degeneration was found in the males, and lengthened estrous cycles in the females. In male rats, alpha-2u-globulin nephropathy was observed in all dosed groups. This effect is species specific and therefore of no relevance for humans. A NOAEL for systemic toxicity could not be derived. A LOAEL of 625 ppm (corresponding to 42 mg/kg bw/day in males and 44 mg/kg bw/day in females) was determined based on effects on the spleen. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88566f42-652f-4bc9-b9c5-1464c936d395/documents/21cd1fe9-58d5-49c5-979d-6c110cd180b9_581c9f20-7428-4348-9a69-830e9fdaeaf5.html,,,,,, Nitrotoluene,1321-12-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88566f42-652f-4bc9-b9c5-1464c936d395/documents/21cd1fe9-58d5-49c5-979d-6c110cd180b9_581c9f20-7428-4348-9a69-830e9fdaeaf5.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,42 mg/kg bw/day,,rat Nitrotoluene,1321-12-6," There is no acute toxicity study available for nitrotoluene (CAS 1321-12-6), but a read-across can be made from 4 -nitrotoluene (CAS 99-99-0): LD50, oral, rat: > 2250 mg/kg bw;   LD50, dermal, rat: > 750 mg/kg bw; LC50, inhalation, rat: > 4200 mg/m³/1h. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88566f42-652f-4bc9-b9c5-1464c936d395/documents/7bb862c7-4827-4d26-89bd-93e85022a725_581c9f20-7428-4348-9a69-830e9fdaeaf5.html,,,,,, N-L-alanyl-L-tyrosine,3061-88-9, The acute oral toxicity of L-Alanyl-L-Tyrosine (L-Ala-L-Tyr) was tested in a study performed according to OECD TG 423. The oral LD50 value was established to exceed 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0441152-3116-4e42-aa4f-756e69ec5ee4/documents/a3ae80be-d482-4bf1-b138-43a88d0f44c9_dc07cba2-e1f2-4513-a0de-eef26f46fd44.html,,,,,, N-L-alanyl-L-tyrosine,3061-88-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0441152-3116-4e42-aa4f-756e69ec5ee4/documents/a3ae80be-d482-4bf1-b138-43a88d0f44c9_dc07cba2-e1f2-4513-a0de-eef26f46fd44.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "N-methoxy-1-(2,4,6-trichlorophenyl)propan-2-amine",1228284-78-3," N-methoxy-1-(2,4,6-trichlorophenyl)propan-2-amine administered once daily by oral gavage to the rat at doses of 0, 10, 25, or 75 mg/kg/day was tolerated for at least 90 days, but elicited adverse hepatic changes at 25 or 75 mg/kg/day.  Hepatic changes seen for males given 10 mg/kg/day were considered to be non-adverse and in the absence of any other notable findings at this dose level, 10 mg/kg/day was concluded to represent the No Observed Adverse Effect Level (NOAEL) for both sexes. After repeat administration of the substance for 90 days, systemic exposure (AUC0-24) on Day 90 increased approximately proportionally with respect to dose in males and more than proportionally in females.  At the NOAEL, exposure was characterised by Cmax and AUC0-24 on Day 90 of 673 ng/mL and 3020 ng.h/mL for males and 372 ng/mL and 1650 ng.h/mL for females, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6fbb421-c4b5-479c-bb5c-66cfa0291a1a/documents/61234666-4c62-454d-9ce4-1f40cd1d5173_4a48f3ae-0dc3-4415-89d2-f8ec29b8177e.html,,,,,, "N-methoxy-1-(2,4,6-trichlorophenyl)propan-2-amine",1228284-78-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6fbb421-c4b5-479c-bb5c-66cfa0291a1a/documents/61234666-4c62-454d-9ce4-1f40cd1d5173_4a48f3ae-0dc3-4415-89d2-f8ec29b8177e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "N-methoxy-1-(2,4,6-trichlorophenyl)propan-2-amine",1228284-78-3," Acute toxicity studies were conducted for N-methoxy-1 -(2,4,6 -trichlorophenyl)propan-2 -amine by oral, dermal and inhalation route of exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6fbb421-c4b5-479c-bb5c-66cfa0291a1a/documents/fd7cd811-8a3a-480b-8f49-034d7c5d7013_4a48f3ae-0dc3-4415-89d2-f8ec29b8177e.html,,,,,, "N-methoxy-1-(2,4,6-trichlorophenyl)propan-2-amine",1228284-78-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6fbb421-c4b5-479c-bb5c-66cfa0291a1a/documents/fd7cd811-8a3a-480b-8f49-034d7c5d7013_4a48f3ae-0dc3-4415-89d2-f8ec29b8177e.html,,oral,LD50,"1,049 mg/kg bw",adverse effect observed, "N-methoxy-1-(2,4,6-trichlorophenyl)propan-2-amine",1228284-78-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6fbb421-c4b5-479c-bb5c-66cfa0291a1a/documents/fd7cd811-8a3a-480b-8f49-034d7c5d7013_4a48f3ae-0dc3-4415-89d2-f8ec29b8177e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "N-methoxy-1-(2,4,6-trichlorophenyl)propan-2-amine",1228284-78-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6fbb421-c4b5-479c-bb5c-66cfa0291a1a/documents/fd7cd811-8a3a-480b-8f49-034d7c5d7013_4a48f3ae-0dc3-4415-89d2-f8ec29b8177e.html,,inhalation,LC50,"5,120 mg/m3",no adverse effect observed, N-methyl-3-(trimethoxysilyl)propylamine,3069-25-8," Oral (OECD 401), rat: LD50 >2000 mg/kg bw ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a20dbed6-97c9-4917-9606-2022f79d1e41/documents/3c713197-d19c-428c-b59c-30904307ab3a_10df0ac5-2e0d-4842-b6eb-8d019b8cea2a.html,,,,,, N-methyl-4-(p-formylstyryl)pyridinium methylsulfate,74401-04-0, NOAEL = 1000 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d34ac6d7-c460-4b5b-b9b8-6f30fc932335/documents/dd941f6d-158e-4db6-a6a9-9f3d79da492d_e860ca6d-2762-4a43-b8ef-0e20d2ab2347.html,,,,,, N-methyl-4-(p-formylstyryl)pyridinium methylsulfate,74401-04-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d34ac6d7-c460-4b5b-b9b8-6f30fc932335/documents/dd941f6d-158e-4db6-a6a9-9f3d79da492d_e860ca6d-2762-4a43-b8ef-0e20d2ab2347.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat N-methyl-4-(p-formylstyryl)pyridinium methylsulfate,74401-04-0, LD50 (oral) > 2000 mg/kg bw LD50 (dermal) > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d34ac6d7-c460-4b5b-b9b8-6f30fc932335/documents/d207cd75-d83b-4206-9496-e257162ad511_e860ca6d-2762-4a43-b8ef-0e20d2ab2347.html,,,,,, N-methyldidecylamine,7396-58-9,"The acute oral toxicity of the substance was assessed using:- an acute oral toxicity test  performed in rats according to OECD 423 guideline and Good Laboratory Practices (Pelcot, 2010)The substance is of moderate acute toxicity following oral exposure:The oral LD50  was comprised between 300 and 2000 mg/kg bw in rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f94ce9ab-9169-444f-9558-eaf931beb068/documents/IUC5-d8009e7c-c573-4413-af2a-0ba0d15db4c1_df818e3d-723c-4403-ae84-dbbd5ba33a1e.html,,,,,, N-methylformanilide,93-61-8," Repeated dose toxicity: via oral route; NOAEL was considered to be in a dose range of 100- 125 mg/kg when male and female rats were exposed to test chemical  for chronic study. Repeated inhalation study: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance of N-methylformanilide (93-61-8) which is reported as 0.02077671 mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical of N-methylformanilide is highly unlikely. Therefore this study is considered for waiver. Repeated dermal study; The acute toxicity value for N-methylformanilide (93-61-8) (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that N-methylformanilide shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that N-methylformanilide shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5ab3373-5306-4ed3-88a2-a5e1762ae90d/documents/da9002d6-f6b4-4ad5-a6a9-7e23612a8290_29f7fe40-c5a6-4d9f-b140-c54eda218009.html,,,,,, N-methylformanilide,93-61-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5ab3373-5306-4ed3-88a2-a5e1762ae90d/documents/da9002d6-f6b4-4ad5-a6a9-7e23612a8290_29f7fe40-c5a6-4d9f-b140-c54eda218009.html,Chronic toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat N-methylformanilide,93-61-8," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is 800 mg/kg bw. The study concluded that LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 4” for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.01995164 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5ab3373-5306-4ed3-88a2-a5e1762ae90d/documents/14441c19-b409-4d82-9553-c578f1b7458c_29f7fe40-c5a6-4d9f-b140-c54eda218009.html,,,,,, N-methylformanilide,93-61-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5ab3373-5306-4ed3-88a2-a5e1762ae90d/documents/14441c19-b409-4d82-9553-c578f1b7458c_29f7fe40-c5a6-4d9f-b140-c54eda218009.html,,oral,LD50,800 mg/kg bw,adverse effect observed, N-methylformanilide,93-61-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5ab3373-5306-4ed3-88a2-a5e1762ae90d/documents/14441c19-b409-4d82-9553-c578f1b7458c_29f7fe40-c5a6-4d9f-b140-c54eda218009.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, N-methyl-N-vinylacetamide,3195-78-6,"Oral: NOAEL < 15 mg/kg bw; rat; OECD 422; GLP; K1; DRAFT Inhalation: NOAEC(systemic) = 50 mg/m³, NOAEC(local) = 0.5 mg/m³; rat; OECD 422, GLP; K1 Dermal: no information available ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57917348-cfe5-4d6b-ab59-6e1aa6905f60/documents/43c7cc46-f719-4247-ba82-b1947fb3dc72_87d798d5-c11d-4bf8-a8d8-f6c36746a7c0.html,,,,,, N-methyl-N-vinylacetamide,3195-78-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57917348-cfe5-4d6b-ab59-6e1aa6905f60/documents/43c7cc46-f719-4247-ba82-b1947fb3dc72_87d798d5-c11d-4bf8-a8d8-f6c36746a7c0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,< 15 mg/kg bw/day,,rat N-methyl-N-vinylacetamide,3195-78-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57917348-cfe5-4d6b-ab59-6e1aa6905f60/documents/43c7cc46-f719-4247-ba82-b1947fb3dc72_87d798d5-c11d-4bf8-a8d8-f6c36746a7c0.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,< 0.5 mg/m3,,rat N-methyl-N-vinylacetamide,3195-78-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57917348-cfe5-4d6b-ab59-6e1aa6905f60/documents/43c7cc46-f719-4247-ba82-b1947fb3dc72_87d798d5-c11d-4bf8-a8d8-f6c36746a7c0.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.5 mg/m3,adverse effect observed,rat N-methyl-N-vinylacetamide,3195-78-6,"Oral: LD50 = 1760 mg/kg; rat; non-guideline; pre-GLP; K2 Inhalation: LC50 > 16207 mg/m³, rat; vapour; 4 hours; non-guideline; pre-GLP; K2 Dermal: LD50 = 1354 mg/kg; rabbit; occlusive; 24 hours; non-guideline; pre-GLP; K2 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57917348-cfe5-4d6b-ab59-6e1aa6905f60/documents/IUC5-bc632273-8d8b-4a54-93f0-c8318f621798_87d798d5-c11d-4bf8-a8d8-f6c36746a7c0.html,,,,,, N-methyl-N-vinylacetamide,3195-78-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57917348-cfe5-4d6b-ab59-6e1aa6905f60/documents/IUC5-bc632273-8d8b-4a54-93f0-c8318f621798_87d798d5-c11d-4bf8-a8d8-f6c36746a7c0.html,,oral,LD50,"1,760 mg/kg bw",adverse effect observed, N-methyl-N-vinylacetamide,3195-78-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57917348-cfe5-4d6b-ab59-6e1aa6905f60/documents/IUC5-bc632273-8d8b-4a54-93f0-c8318f621798_87d798d5-c11d-4bf8-a8d8-f6c36746a7c0.html,,dermal,LD50,"1,354 mg/kg bw",adverse effect observed, N-methyl-N-vinylacetamide,3195-78-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57917348-cfe5-4d6b-ab59-6e1aa6905f60/documents/IUC5-bc632273-8d8b-4a54-93f0-c8318f621798_87d798d5-c11d-4bf8-a8d8-f6c36746a7c0.html,,inhalation,discriminating conc.,"16,207 mg/m3",no adverse effect observed, "N-methyl-P,P-bis(2-methylaziridin-1-yl)phosphinamide",85068-72-0," Rat Oral LD50: >50 - <300 mg/kg bw (OECD 423, GLP, Rel. 1, K). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53e6e94b-9717-4f2b-8ac6-bfb9599e645a/documents/8c302348-b1aa-41a9-8900-75012838f351_dc56da89-fca1-4286-8ee6-1db6aaaac32c.html,,,,,, "N-methyl-P,P-bis(2-methylaziridin-1-yl)phosphinamide",85068-72-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53e6e94b-9717-4f2b-8ac6-bfb9599e645a/documents/8c302348-b1aa-41a9-8900-75012838f351_dc56da89-fca1-4286-8ee6-1db6aaaac32c.html,,oral,LD50,200 mg/kg bw,adverse effect observed, Nonamethylenediamine,646-24-2,"There are no repeated dose toxicity studies available for NMDA. After polymerisation, a monomer ceases to exist as a substance on its own and is transformed into a new substance, the polymer. NMDA is exclusively imported into the EU as a polymer and exposure to the monomer at any stage of the lifecycle of the polymer can be excluded as demonstrated by a thorough and rigorous exposure assessment (attached in section 13). 2-Methyl-1,8-octanediamine (MODA), which can be present in NMDA up to 15%, was tested in a subacute oral toxicity study with Sprague-Dawley rats according to the relevant Japanese Guidelines and in accordance with the principles of GLP. The no-observed-effect level (NOEL) for MODA was determined to be 30 mg/kg bw/day under the conditions of the present study. Repeated exposure resulted in mortality at 150 mg/kg bw/d, which was concluded to be sufficient evidence for classification as STOT-RE 2 (H373).     ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee0bb552-f4be-47c8-b6ea-e5fbc5a2a771/documents/IUC5-7b689324-e05f-4b2e-be6a-add16ef461d2_28712f2f-c252-4b6d-90ee-fd723a9ab56b.html,,,,,, Nonamethylenediamine,646-24-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee0bb552-f4be-47c8-b6ea-e5fbc5a2a771/documents/IUC5-7b689324-e05f-4b2e-be6a-add16ef461d2_28712f2f-c252-4b6d-90ee-fd723a9ab56b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat Nonamethylenediamine,646-24-2,"The acute lethal oral dose (LD50) to mice for NMDA was concluded to exceed 300 mg/kg bw. Inhalation and dermal studies were not conducted due to the corrosive properties of the substance. The data justify classification according to Regulation (EC) No 1272/2008 as Acute Tox. 4 (oral); H302, harmful if swallowed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee0bb552-f4be-47c8-b6ea-e5fbc5a2a771/documents/IUC5-c09896e1-8c8c-480d-af1e-b0a649d95ce3_28712f2f-c252-4b6d-90ee-fd723a9ab56b.html,,,,,, Nonamethylenediamine,646-24-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ee0bb552-f4be-47c8-b6ea-e5fbc5a2a771/documents/IUC5-c09896e1-8c8c-480d-af1e-b0a649d95ce3_28712f2f-c252-4b6d-90ee-fd723a9ab56b.html,,oral,LD50,>=300 mg/kg bw,adverse effect observed, "N,N-dimethylnonanamide",6225-08-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): One recently performed guideline study ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57a529f1-a12b-4467-9e8a-2f98f5a324c8/documents/8b97f6a5-7706-4176-a826-6304a252f8e4_58540c45-0827-4f31-857a-4a654942f623.html,,,,,, "N,N-dimethylnonanamide",6225-08-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/57a529f1-a12b-4467-9e8a-2f98f5a324c8/documents/8b97f6a5-7706-4176-a826-6304a252f8e4_58540c45-0827-4f31-857a-4a654942f623.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "N,N-dimethylnonanamide",6225-08-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): One valid Guideline study. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): One valid Guideline study. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57a529f1-a12b-4467-9e8a-2f98f5a324c8/documents/eba0e64c-a14e-412d-87c0-7960386d6a5d_58540c45-0827-4f31-857a-4a654942f623.html,,,,,, "N,N-dimethylnonanamide",6225-08-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57a529f1-a12b-4467-9e8a-2f98f5a324c8/documents/eba0e64c-a14e-412d-87c0-7960386d6a5d_58540c45-0827-4f31-857a-4a654942f623.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "N,N-dimethylnonanamide",6225-08-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/57a529f1-a12b-4467-9e8a-2f98f5a324c8/documents/eba0e64c-a14e-412d-87c0-7960386d6a5d_58540c45-0827-4f31-857a-4a654942f623.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Nonane-1,9-diol",3937-56-2,"An oral 90-day study in the rat according to OECD 408 and GLP guidelines using the test substance nonanediol (CAS 3937-56-2) has been conducted. No adverse effects were observed at 1000 mg/kg bw/day, the maximum dose tested.The 28-day study in rodents according to OECD 407 is waived based on the 90 day study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ddfc5a9-2e82-463f-bf2b-16c02bdbf094/documents/49bc6369-6504-4e85-b850-c1e1d39397b7_2fdeb943-39bc-4977-b945-b9f064a65184.html,,,,,, "Nonane-1,9-diol",3937-56-2,"Short summary and overall relevance of the provided information on acute oral toxicity: A rat acute oral toxicity study has been conducted on 1,9 -Nonanediol under OECD 401.  In a rat acute oral toxicity study 5 male and 5 female Sprague-Dawley rats received as single oral dose (via gavage) of 1,9-Nonanediol suspended in 0.5% w/v methylcellulose at 1260, 2000, 3200, 4000 or 5200 mg/kg bw. Rats were observed for 14 days. For all rats body weights were measured and a gross necropsy was performed at the end of the observation period. Treatment related clinical signs included hunched post mortem abnormal gait, ataxia and lethargy in the majority of animals dose at all levels. Group mean body weight gains were not affected. Mortality was observed in males dosed at 2000 mg/kg bw and above an in females dosed at 3200 mg/kg bw and above. No abnormalities were recorded at necropsy.   Short summary and overall relevance of the provided information on acute inhalation toxicity: In accordance with the ECHA Chapter R.7a guidance, a waiver is requested as exposure of humans via inhalation is not likely taking account the vapour pressure of the test article, 1,9 Nonanediol. Short summary and overall relevance of the provided information on acute dermal toxicity In accordance with the ECHA Chapter R.7a guidance, a waiver is requested as 1,9 Nonanediol is neither toxic via the oral route and no evidence of systemic toxicity has been observed in either the in vivo skin irritation/corrosion test or the skin sensitisation test. Consequently the need to classify for these endpoints is not triggered. Based on these toxicological endpoints, the rationale to submit a waiver for the acute dermal toxicity endpoint as stated in the R.7a guidance for REACh is scientifically robust. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ddfc5a9-2e82-463f-bf2b-16c02bdbf094/documents/bfe6fe16-0510-40f2-8876-6cff1a7c227b_2fdeb943-39bc-4977-b945-b9f064a65184.html,,,,,, "Nonane-1,9-diol",3937-56-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ddfc5a9-2e82-463f-bf2b-16c02bdbf094/documents/bfe6fe16-0510-40f2-8876-6cff1a7c227b_2fdeb943-39bc-4977-b945-b9f064a65184.html,,oral,LD50,"3,200 mg/kg bw",no adverse effect observed, "Nonanedioic acid, 1,9-bis(2-octyldodecyl) ester",897626-46-9,"In conclusion, no human hazard for systemic toxicity after repeated oral, dermal, or inhalation exposure was identified for the PFAE linear category members. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ef789f3-af8e-4a41-a14b-b32087f7a194/documents/IUC5-dd2d6253-0c24-401c-af18-c0bd320221fe_80bb9440-6158-4425-a747-1e04600f96e2.html,,,,,, "Nonanedioic acid, 1,9-bis(2-octyldodecyl) ester",897626-46-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ef789f3-af8e-4a41-a14b-b32087f7a194/documents/IUC5-dd2d6253-0c24-401c-af18-c0bd320221fe_80bb9440-6158-4425-a747-1e04600f96e2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Nonanedioic acid, 1,9-bis(2-octyldodecyl) ester",897626-46-9,All available acute oral toxicity studies within this category resulted in acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.7 mg/L. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ef789f3-af8e-4a41-a14b-b32087f7a194/documents/IUC5-d96fb022-37bf-459f-a258-7dd28a3efaba_80bb9440-6158-4425-a747-1e04600f96e2.html,,,,,, "Nonanoic acid, mixed esters with heptanoic acid, pentaerythritol and valeric acid",70693-39-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable (Klimisch score 2) study from a source substance with similar structure and intrinsic properties. Read-across is justified based on common precursors and hydrolysis products and consistent trends in environmental fate, ecotoxicological and toxicological profile. The selected study is thus sufficient to fulfil the standard information requirements set out in Annexes VIII - X, 8.6, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable (Klimisch score 2) study from a source substance with similar structure and intrinsic properties. Read-across is justified based on common precursors and hydrolysis products and consistent trends in environmental fate, ecotoxicological and toxicological profile. The selected study is thus sufficient to fulfil the standard information requirements set out in Annexes VIII - X, 8.6, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable (Klimisch score 2) study from a source substance with similar structure and intrinsic properties. Read-across is justified based on common precursors and hydrolysis products and consistent trends in environmental fate, ecotoxicological and toxicological profile. The selected study is thus sufficient to fulfil the standard information requirements set out in Annexes VIII - X, 8.6, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable (Klimisch score 2) study from a source substance with similar structure and intrinsic properties. Read-across is justified based on common precursors and hydrolysis products and consistent trends in environmental fate, ecotoxicological and toxicological profile. The selected study is thus sufficient to fulfil the standard information requirements set out in Annexes VIII - X, 8.6, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises adequate and reliable (Klimisch score 1 and 2) studies with the registered substance and from various source substances with similar structures and intrinsic properties. Read-across is justified based on common precursors and hydrolysis products and consistent trends in environmental fate, ecotoxicological and toxicological profile. The selected studies are thus sufficient to fulfil the standard information requirements set out in Annexes VIII - X, 8.6, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/721a0ea4-ee00-43eb-94ca-ddd3a3599299/documents/dc66d80e-29fc-433e-a67e-ed7202cdcb5f_20c0c584-6314-452f-9a17-d6ac9437e5a0.html,,,,,, "Nonanoic acid, mixed esters with heptanoic acid, pentaerythritol and valeric acid",70693-39-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/721a0ea4-ee00-43eb-94ca-ddd3a3599299/documents/dc66d80e-29fc-433e-a67e-ed7202cdcb5f_20c0c584-6314-452f-9a17-d6ac9437e5a0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Nonanoic acid, mixed esters with heptanoic acid, pentaerythritol and valeric acid",70693-39-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/721a0ea4-ee00-43eb-94ca-ddd3a3599299/documents/dc66d80e-29fc-433e-a67e-ed7202cdcb5f_20c0c584-6314-452f-9a17-d6ac9437e5a0.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rat "Nonanoic acid, mixed esters with heptanoic acid, pentaerythritol and valeric acid",70693-39-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/721a0ea4-ee00-43eb-94ca-ddd3a3599299/documents/dc66d80e-29fc-433e-a67e-ed7202cdcb5f_20c0c584-6314-452f-9a17-d6ac9437e5a0.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,500 mg/m3,,rat "Nonanoic acid, mixed esters with heptanoic acid, pentaerythritol and valeric acid",70693-39-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/721a0ea4-ee00-43eb-94ca-ddd3a3599299/documents/dc66d80e-29fc-433e-a67e-ed7202cdcb5f_20c0c584-6314-452f-9a17-d6ac9437e5a0.html,Repeated dose toxicity – local effects,dermal,LOAEL,800 mg/cm2,adverse effect observed,rat "Nonanoic acid, mixed esters with heptanoic acid, pentaerythritol and valeric acid",70693-39-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/721a0ea4-ee00-43eb-94ca-ddd3a3599299/documents/dc66d80e-29fc-433e-a67e-ed7202cdcb5f_20c0c584-6314-452f-9a17-d6ac9437e5a0.html,Repeated dose toxicity – local effects,inhalation,NOAEC,500 mg/m3,no adverse effect observed,rat "Nonanoic acid, mixed esters with heptanoic acid, pentaerythritol and valeric acid",70693-39-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate and reliable (Klimisch score 1 and 2) studies from various source substances with similar structures and intrinsic properties. Read-across is justified based on common precursors and hydrolysis products and consistent trends in environmental fate, ecotoxicological and toxicological profile. The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The available information comprises adequate and reliable (Klimisch score 2) studies from various source substances with similar structures and intrinsic properties. Read-across is justified based on common precursors and hydrolysis products and consistent trends in environmental fate, ecotoxicological and toxicological profile. The selected studies are thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/721a0ea4-ee00-43eb-94ca-ddd3a3599299/documents/358ed5ab-f0b8-4a7b-9d30-3f30fc5629d9_20c0c584-6314-452f-9a17-d6ac9437e5a0.html,,,,,, "nonanol, branched and linear",68515-81-1,"There are no repeated dose toxicity data for the registration substance Nonan-1-ol, branched and linear. Therefore, key data for the Category member hexan-1-ol have been used for this endpoint.   A read across from a reliable 13-week dietary study in rats using hexan-1-ol reported a NOAEL of 1127 mg/kg bw/day (Scientific Associates Inc., 1966).   A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with the structural analogue Alcohols, C9-11, branched and linear (CAS 85711-26-8; EC 288-284-4) has been conducted according to OECD Test Guideline 422 and in compliance with GLP. A number of other OECD Test Guideline 422 studies are also being conducted in support of the category approach (see Section 13 - 'Amendment_Category testing strategy' and 'Category Report - Toxicity').    There is an ongoing 90-day oral repeated dose toxicity study conducted according to OECD Test Guideline 408 with Alcohols, C9-11, branched and linear. The test is running late due to sample issues at the laboratory site (please see CRO statement for further details in the EPSR titled Repeated dose toxicity: oral_Ongoing 408 study with C911BL'). As soon as a report is made available, and supporting OECD 422 studies are completed, all data used as read-across to the registered substance Nonan-1-ol, branched and linear (CAS 68515-81-1) and the dataset as well as the DNELs will be updated according to the results.    The read-across data from hexan-1-ol is kept as an interim target and approach for risk assessment purposes.  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Reliable (2) repeated dose feeding study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e269820-b631-40cb-b9be-fed5eab1989f/documents/67ba6e4e-3b20-4168-b7fb-e37548e8cb5c_6b839cf1-a312-4028-96e7-9669b5e064b8.html,,,,,, "nonanol, branched and linear",68515-81-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e269820-b631-40cb-b9be-fed5eab1989f/documents/67ba6e4e-3b20-4168-b7fb-e37548e8cb5c_6b839cf1-a312-4028-96e7-9669b5e064b8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,127 mg/kg bw/day",,rat "nonanol, branched and linear",68515-81-1,"All the acute toxicity key studies are read across from a structural analogous substance decan-1-ol (CAS 112-30-1).   The key acute oral toxicity study with decan-1-ol in rat, conducted according to a protocol similar to OECD Test Guideline 423 and in compliance with GLP, reports an LD50 value of >5000 mg/kg bw (Eurofins 2008; rel 1).   The key acute inhalation toxicity study with decan-1-ol, conducted prior to OECD Test Guideline and GLP, reported an LC50 of >71mg/L in rats, following 1-hour whole body inhalation exposure to the atmosphere generated as a mist (Scientific Associates 1977; rel 2).   The key acute dermal toxicity study with decan-1-ol, conducted according to a protocol similar to OECD Test Guideline 402 and in compliance with GLP, reports an LD50 value of >5000 mg/kg bw in rat (Eurofins 2009; rel 1). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e269820-b631-40cb-b9be-fed5eab1989f/documents/55f8a96b-ef21-4492-bfd3-55022f5ea7fe_6b839cf1-a312-4028-96e7-9669b5e064b8.html,,,,,, "nonanol, branched and linear",68515-81-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e269820-b631-40cb-b9be-fed5eab1989f/documents/55f8a96b-ef21-4492-bfd3-55022f5ea7fe_6b839cf1-a312-4028-96e7-9669b5e064b8.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "nonanol, branched and linear",68515-81-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e269820-b631-40cb-b9be-fed5eab1989f/documents/55f8a96b-ef21-4492-bfd3-55022f5ea7fe_6b839cf1-a312-4028-96e7-9669b5e064b8.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "nonanol, branched and linear",68515-81-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e269820-b631-40cb-b9be-fed5eab1989f/documents/55f8a96b-ef21-4492-bfd3-55022f5ea7fe_6b839cf1-a312-4028-96e7-9669b5e064b8.html,,inhalation,LC50,"71,000 mg/m3",no adverse effect observed, Potassium methylsilanetriolate,31795-24-1,"An oral OECD 422 screening test (Dow Corning Corporation, 2005) in rats is available for the read across substance substance trimethoxy(methyl)silane. The NOAEL for systemic effects was determined to be 50 mg/kg/day, based on findings in a number of organs including the liver and thymus gland. The key study (Dow Corning Corporation, 2007) for repeated dose toxicity via the inhalation route, is a 90-day whole-body inhalation study, in which trimethoxy(methyl)silane was administered to rats six hours per day, five days per week. The NOAEC of 100 ppm (560 mg/m3) was based on an increased incidence of grossly observed urinary bladder calculi along with kidney dilation at the 400 ppm exposure concentration. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf1a87bb-6bd8-4242-b224-28adfbc744c7/documents/IUC5-be0b0110-d16d-459e-a95e-a09dce072864_42d0fe2e-f90b-467f-beac-f76d13275c2a.html,,,,,, Potassium methylsilanetriolate,31795-24-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf1a87bb-6bd8-4242-b224-28adfbc744c7/documents/IUC5-be0b0110-d16d-459e-a95e-a09dce072864_42d0fe2e-f90b-467f-beac-f76d13275c2a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Potassium methylsilanetriolate,31795-24-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf1a87bb-6bd8-4242-b224-28adfbc744c7/documents/IUC5-be0b0110-d16d-459e-a95e-a09dce072864_42d0fe2e-f90b-467f-beac-f76d13275c2a.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,560 mg/m3,,rat Potassium methylsilanetriolate,31795-24-1,"The acute oral LD50 of potassium methylsilanetriolate was determined to be >2000 mg/kg in a study conducted according to OECD 423 (acute toxic class method) and in compliance with GLP (LPT, 2002). No data are available for the dermal or inhalation routes. In accordance with Column 2 of REACH Annex VIII, the inhalation and dermal toxicity studies (required in Sections 8.5.2 and 8.5.3) do not need to be conducted as the substance is classified as corrosive. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf1a87bb-6bd8-4242-b224-28adfbc744c7/documents/IUC5-59ae5f91-0ad5-45df-a2e1-d2dc67249727_42d0fe2e-f90b-467f-beac-f76d13275c2a.html,,,,,, Potassium methylsilanetriolate,31795-24-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf1a87bb-6bd8-4242-b224-28adfbc744c7/documents/IUC5-59ae5f91-0ad5-45df-a2e1-d2dc67249727_42d0fe2e-f90b-467f-beac-f76d13275c2a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Nonene,27215-95-8,"Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available.For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members. The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3). The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cde5b219-e220-4db4-b33c-1f1ea2c3b880/documents/f050a53c-5348-4b39-9f36-67e63e5070ea_72755502-0bd1-4b83-b11b-4d99893f59bb.html,,,,,, Nonene,27215-95-8,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cde5b219-e220-4db4-b33c-1f1ea2c3b880/documents/58cd9bd2-0f0e-4229-8111-a2b8f77878b7_72755502-0bd1-4b83-b11b-4d99893f59bb.html,,,,,, "Nonene, branched",97280-95-0,"Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available.For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members. The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3). The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3f0a13f-ca68-4ef2-8993-77ca4df67774/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_731c2e29-b9bb-4064-a394-8b60cf96710f.html,,,,,, "Nonene, branched",97280-95-0,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3f0a13f-ca68-4ef2-8993-77ca4df67774/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_731c2e29-b9bb-4064-a394-8b60cf96710f.html,,,,,, "Nonylbenzoate, branched and linear",670241-72-2,"28 day repeated dose oral in rats: NOEL females = 150 mg/kg day; NOEL males = 15 mg/kg/day (based on hydrocarbon nephropathy, which only occurs in male rats and is not indicatice of a hazard to human health) 90 day repeated dose oral in rats: NOEL = 300 mg/kg/day90 day repeated dose inhalation in rats: Based on the irritant effects in group 4, the No-Observed-Adverse-Effect-Level (NOAEL) was considered to be 0.400 mg/L air. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0727287-2e55-47f8-897b-776425c2d753/documents/IUC5-4ea28588-8faa-4541-a027-5443bbe6360c_b413d7ae-8426-49c4-913e-2218da537bf6.html,,,,,, "Nonylbenzoate, branched and linear",670241-72-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0727287-2e55-47f8-897b-776425c2d753/documents/IUC5-4ea28588-8faa-4541-a027-5443bbe6360c_b413d7ae-8426-49c4-913e-2218da537bf6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Nonylbenzoate, branched and linear",670241-72-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0727287-2e55-47f8-897b-776425c2d753/documents/IUC5-4ea28588-8faa-4541-a027-5443bbe6360c_b413d7ae-8426-49c4-913e-2218da537bf6.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,400 mg/m3,,rat "Nonylbenzoate, branched and linear",670241-72-2,The test item benzoic acid isononylester is of low acute toxicity as shown by the follwoing results:Acute toxicity oral (by gavage): LD50 > 2500 mg/kgAcute toxicity dermal: LD50 > 2000 mg/kgAcute toxicity inhalation: LC50 > 5.2 mg/L ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0727287-2e55-47f8-897b-776425c2d753/documents/IUC5-75d86948-c562-4df8-8e30-cfdae1a935e7_b413d7ae-8426-49c4-913e-2218da537bf6.html,,,,,, "N-phenyl-4-[[4-(phenylamino)phenyl][4-(phenylimino)cyclohexa-2,5-dien-1-ylidene]methyl]aniline monohydrochloride",2152-64-9," Prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound N-phenyl-4-[[4-(phenylamino) phenyl][4-(phenylimino)cyclohexa-2 ,5-dien-1-ylidene] methyl]aniline monohydrochloride. The study assumed the use of male and female Sprague-Dawley rats in subchronic study of 5 weeks. No significant alterations were noted at the dose level of 850.04mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for N-phenyl-4-[[4-(phenylamino)phenyl][4 -(phenylimino)cyclohexa-2,5-dien-1-ylidene]methyl]aniline monohydrochloride is considered to be 850.04mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e21422cc-4a96-465c-8365-ad8b37e3feaf/documents/2f907729-d686-4093-8210-4ec255556651_eb2af99d-4828-4502-81a1-0d733e6b71f3.html,,,,,, "N-phenyl-4-[[4-(phenylamino)phenyl][4-(phenylimino)cyclohexa-2,5-dien-1-ylidene]methyl]aniline monohydrochloride",2152-64-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e21422cc-4a96-465c-8365-ad8b37e3feaf/documents/2f907729-d686-4093-8210-4ec255556651_eb2af99d-4828-4502-81a1-0d733e6b71f3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,850.04 mg/kg bw/day,,rat "N-phenyl-4-[[4-(phenylamino)phenyl][4-(phenylimino)cyclohexa-2,5-dien-1-ylidene]methyl]aniline monohydrochloride",2152-64-9," Acute oral toxicity:  LD50 was considered to be 23902 mg/kg bw when Sprague-Dawley male and female rats were orally exposed with N-phenyl-4-[[4-(phenylamino)phenyl][4-(phenylimino)cyclohexa-2,5-dien-1-ylidene]methyl]aniline monohydrochloride. Acute Inhalation toxicity:  LC50 was considered to be 59.7 mg/L in air when WAG/RijCrlBR male rats were exposed with N-phenyl-4-[[4-(phenylamino)phenyl][4-(phenylimino)cyclohexa-2,5-dien-1-ylidene]methyl]aniline monohydrochloride by inhalation. Acute Dermal toxicity:  LD50 was considered to be 8191 mg/kg bw, when Crj: CD(SD) male and female rats were treated with N-phenyl-4-[[4-(phenylamino)phenyl][4-(phenylimino)cyclohexa-2,5-dien-1-ylidene]methyl]aniline monohydrochloride by dermal application. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e21422cc-4a96-465c-8365-ad8b37e3feaf/documents/b3f397d3-1703-4f3c-9852-1584d7a82c0c_eb2af99d-4828-4502-81a1-0d733e6b71f3.html,,,,,, "N-phenyl-4-[[4-(phenylamino)phenyl][4-(phenylimino)cyclohexa-2,5-dien-1-ylidene]methyl]aniline monohydrochloride",2152-64-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e21422cc-4a96-465c-8365-ad8b37e3feaf/documents/b3f397d3-1703-4f3c-9852-1584d7a82c0c_eb2af99d-4828-4502-81a1-0d733e6b71f3.html,,oral,LD50,"23,902 mg/kg bw",no adverse effect observed, "N-phenyl-4-[[4-(phenylamino)phenyl][4-(phenylimino)cyclohexa-2,5-dien-1-ylidene]methyl]aniline monohydrochloride",2152-64-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e21422cc-4a96-465c-8365-ad8b37e3feaf/documents/b3f397d3-1703-4f3c-9852-1584d7a82c0c_eb2af99d-4828-4502-81a1-0d733e6b71f3.html,,dermal,LD50,"8,191 mg/kg bw",no adverse effect observed, "N-phenyl-4-[[4-(phenylamino)phenyl][4-(phenylimino)cyclohexa-2,5-dien-1-ylidene]methyl]aniline monohydrochloride",2152-64-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e21422cc-4a96-465c-8365-ad8b37e3feaf/documents/b3f397d3-1703-4f3c-9852-1584d7a82c0c_eb2af99d-4828-4502-81a1-0d733e6b71f3.html,,inhalation,LC50,"59,700 mg/m3",no adverse effect observed, N-phenylmaleimide,941-69-5,The NOAEL for oral is 3.5 mg/kg/day.The NOAEL for inhalation is 0.21 mg/m3. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e2e349f-d517-445e-a09f-ec395b4eafe4/documents/IUC5-3f5cdce4-59c5-4b29-a5e5-5b0b8b1e2bde_de7104c3-4b40-4f71-a368-e476c3a0649a.html,,,,,, N-phenylmaleimide,941-69-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e2e349f-d517-445e-a09f-ec395b4eafe4/documents/IUC5-3f5cdce4-59c5-4b29-a5e5-5b0b8b1e2bde_de7104c3-4b40-4f71-a368-e476c3a0649a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,3.5 mg/kg bw/day,,rat N-phenylmaleimide,941-69-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e2e349f-d517-445e-a09f-ec395b4eafe4/documents/IUC5-3f5cdce4-59c5-4b29-a5e5-5b0b8b1e2bde_de7104c3-4b40-4f71-a368-e476c3a0649a.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,0.21 mg/m3,,rat N-phenylmaleimide,941-69-5,"LD50 = 128.0 mg/kg-oral male ratLD50 = 148.3 mg/kg-oral female rat4h-LC50 = 0.034 mg/L-inhalation ratAcute dermal data of this substance is scientifically waived due to low potential based on irritative but not corrosive property to skin, and low Kow (1.09) is not supposed to be absorbed through the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e2e349f-d517-445e-a09f-ec395b4eafe4/documents/IUC5-14528c3d-df92-4b29-9409-f5dda62b9d1d_de7104c3-4b40-4f71-a368-e476c3a0649a.html,,,,,, N-phenylmaleimide,941-69-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e2e349f-d517-445e-a09f-ec395b4eafe4/documents/IUC5-14528c3d-df92-4b29-9409-f5dda62b9d1d_de7104c3-4b40-4f71-a368-e476c3a0649a.html,,oral,LD50,128 mg/kg bw,, N-phenylmaleimide,941-69-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e2e349f-d517-445e-a09f-ec395b4eafe4/documents/IUC5-14528c3d-df92-4b29-9409-f5dda62b9d1d_de7104c3-4b40-4f71-a368-e476c3a0649a.html,,inhalation,LC50,34 mg/m3,, N-phenyl-N-[(trichloromethyl)thio]benzenesulphonamide,2280-49-1,"Repeat Dose Toxicity - Oral: - sub-chronic NOAEL (systemic effects) = 4500 ppm, ca. 320 mg/kg bw/day in males and 417 mg/kg bw/day in females (OECD 408, diet, GLP, 2024, Key, Rel. 1) - sub-acute NOEL (systemic effects) = 500 mg/kg bw/day and NOAEL (local effects) 50 mg/kg/day (OECD 407,gavage, GLP, 2013, Key Rel. 1)  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/daa90c50-970c-4ff3-9dcb-b0dfbff66d68/documents/612c623f-4963-4058-933b-89db23318c46_6605d403-6fc0-44ce-9083-524d2edda983.html,,,,,, N-phenyl-N-[(trichloromethyl)thio]benzenesulphonamide,2280-49-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/daa90c50-970c-4ff3-9dcb-b0dfbff66d68/documents/612c623f-4963-4058-933b-89db23318c46_6605d403-6fc0-44ce-9083-524d2edda983.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat N-phenyl-N-[(trichloromethyl)thio]benzenesulphonamide,2280-49-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/daa90c50-970c-4ff3-9dcb-b0dfbff66d68/documents/612c623f-4963-4058-933b-89db23318c46_6605d403-6fc0-44ce-9083-524d2edda983.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,ca.320 mg/kg bw/day,,rat N-phenyl-N-[(trichloromethyl)thio]benzenesulphonamide,2280-49-1,"Acute Oral Toxicity: LD0 >2500 mg/kg bw (Eqv. OECD 401, Key Rel. 2) Acute Dermal Toxicity: Discriminating Dose >=500 mg/kg bw (No Guideline, Key Rel. 2) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/daa90c50-970c-4ff3-9dcb-b0dfbff66d68/documents/IUC5-42627286-60ef-4be7-9bc0-0d0526c64af3_6605d403-6fc0-44ce-9083-524d2edda983.html,,,,,, N-phenyl-N-[(trichloromethyl)thio]benzenesulphonamide,2280-49-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/daa90c50-970c-4ff3-9dcb-b0dfbff66d68/documents/IUC5-42627286-60ef-4be7-9bc0-0d0526c64af3_6605d403-6fc0-44ce-9083-524d2edda983.html,,oral,LD0,"> 2,500 mg/kg bw",adverse effect observed, N-phenyl-N-[(trichloromethyl)thio]benzenesulphonamide,2280-49-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/daa90c50-970c-4ff3-9dcb-b0dfbff66d68/documents/IUC5-42627286-60ef-4be7-9bc0-0d0526c64af3_6605d403-6fc0-44ce-9083-524d2edda983.html,,dermal,LD0,>=500 mg/kg bw,no adverse effect observed, N-sodiohexamethyldisilazane,1070-89-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): LD50 was calculated based on an assumed density of 1000 mg/mL. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/518532e4-8f61-4800-88c2-25dbe0b17446/documents/IUC5-411b4466-4d50-41d3-9257-9a46a152767e_53ebbbdf-9d13-48cb-bbd9-b598f3e07cb8.html,,,,,, N-sodiohexamethyldisilazane,1070-89-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/518532e4-8f61-4800-88c2-25dbe0b17446/documents/IUC5-411b4466-4d50-41d3-9257-9a46a152767e_53ebbbdf-9d13-48cb-bbd9-b598f3e07cb8.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, N-sodiohexamethyldisilazane,1070-89-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/518532e4-8f61-4800-88c2-25dbe0b17446/documents/IUC5-411b4466-4d50-41d3-9257-9a46a152767e_53ebbbdf-9d13-48cb-bbd9-b598f3e07cb8.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, N-sodiohexamethyldisilazane,1070-89-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/518532e4-8f61-4800-88c2-25dbe0b17446/documents/IUC5-411b4466-4d50-41d3-9257-9a46a152767e_53ebbbdf-9d13-48cb-bbd9-b598f3e07cb8.html,,inhalation,LC50,"10,300 mg/m3",adverse effect observed, N-tert-butylbenzothiazole-2-sulphenamide,95-31-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): The available study is GLP and assigned high quality (Klimisch 1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Klimisch 3 rated study with significant methodological restrictions (test substance purity not indicated; the study is limited concerning the recommended particle-size distribution given in current guidelines and thus an exposure of all relevant regions of the respiratory tract was presumably not given. Effects noted should be used for supporting purposes only. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch 3 rated study with significant methodological restrictions (test substance purity not indicated; the study is limited concerning the recommended particle-size distribution given in current guidelines and thus an exposure of all relevant regions of the respiratory tract was presumably not given. Effects noted should be used for supporting purposes only. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): The available study is GLP and assigned high quality (Klimisch 1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The endpoint is concluded based on a key subchronic toxicity study on TBBS conducted to GLP and test guideline (OECD 408). It has been evaluated to be of good quality (Klimisch score = 1). Further supporting evidence is available from Supporting studies of good quality (Klimisch scores 1 & 2) conducted to test guideline or good scientific principle, and well documented. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b72a382-a8af-4026-874a-82b48ae6b47a/documents/939d6130-f751-420a-86b1-b59e448c8919_fe48d016-0379-4d98-8f7f-c6949075630a.html,,,,,, N-tert-butylbenzothiazole-2-sulphenamide,95-31-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b72a382-a8af-4026-874a-82b48ae6b47a/documents/939d6130-f751-420a-86b1-b59e448c8919_fe48d016-0379-4d98-8f7f-c6949075630a.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rabbit N-tert-butylbenzothiazole-2-sulphenamide,95-31-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b72a382-a8af-4026-874a-82b48ae6b47a/documents/939d6130-f751-420a-86b1-b59e448c8919_fe48d016-0379-4d98-8f7f-c6949075630a.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,29 mg/m3,,rat N-tert-butylbenzothiazole-2-sulphenamide,95-31-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b72a382-a8af-4026-874a-82b48ae6b47a/documents/939d6130-f751-420a-86b1-b59e448c8919_fe48d016-0379-4d98-8f7f-c6949075630a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat N-tert-butylbenzothiazole-2-sulphenamide,95-31-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b72a382-a8af-4026-874a-82b48ae6b47a/documents/939d6130-f751-420a-86b1-b59e448c8919_fe48d016-0379-4d98-8f7f-c6949075630a.html,Repeated dose toxicity – local effects,dermal,NOAEL,6 mg/cm2,adverse effect observed,rabbit N-tert-butylbenzothiazole-2-sulphenamide,95-31-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b72a382-a8af-4026-874a-82b48ae6b47a/documents/939d6130-f751-420a-86b1-b59e448c8919_fe48d016-0379-4d98-8f7f-c6949075630a.html,Repeated dose toxicity – local effects,inhalation,NOAEC,84 mg/m3,no adverse effect observed,rat N-tert-butylbenzothiazole-2-sulphenamide,95-31-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Limited but acceptable documented study report which meets basic scientific principles. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Limited but acceptable documented study report which meets basic scientific principles. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b72a382-a8af-4026-874a-82b48ae6b47a/documents/e2219e52-aeb8-4421-98f2-cd8c0c7772ce_fe48d016-0379-4d98-8f7f-c6949075630a.html,,,,,, N-tert-butylbenzothiazole-2-sulphenamide,95-31-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b72a382-a8af-4026-874a-82b48ae6b47a/documents/e2219e52-aeb8-4421-98f2-cd8c0c7772ce_fe48d016-0379-4d98-8f7f-c6949075630a.html,,oral,LD50,"6,310 mg/kg bw",adverse effect observed, N-tert-butylbenzothiazole-2-sulphenamide,95-31-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b72a382-a8af-4026-874a-82b48ae6b47a/documents/e2219e52-aeb8-4421-98f2-cd8c0c7772ce_fe48d016-0379-4d98-8f7f-c6949075630a.html,,dermal,discriminating dose,"7,940 mg/kg bw",no adverse effect observed, N-vinylformamide,13162-05-5,"Repeated inhalation toxicity (90 days): NOAEC = 50 mg/m³ (BASF AG, 1995). This value served as the point of departure for DNEL derivation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2eaf0a41-54cc-40a0-b88f-fca60d24d650/documents/IUC5-a35ab20c-3234-4c06-b895-e825b8e0826d_d3099007-333f-4b70-a5fd-640a849f8e1f.html,,,,,, N-vinylformamide,13162-05-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2eaf0a41-54cc-40a0-b88f-fca60d24d650/documents/IUC5-a35ab20c-3234-4c06-b895-e825b8e0826d_d3099007-333f-4b70-a5fd-640a849f8e1f.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,50 mg/m3,,rat N-vinylformamide,13162-05-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2eaf0a41-54cc-40a0-b88f-fca60d24d650/documents/IUC5-a35ab20c-3234-4c06-b895-e825b8e0826d_d3099007-333f-4b70-a5fd-640a849f8e1f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,50 mg/m3,adverse effect observed,rat N-vinylformamide,13162-05-5,"LD50, rat, oral: > 1000 < 2000 mg/kg (67/548/EEC: R22; CLP 1272/2008: Acute oral Cat. 4)LC50 inhalation: no mortality in an inhalation hazard test with saturated vapour of the test substance.LD50 dermal: > 2000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2eaf0a41-54cc-40a0-b88f-fca60d24d650/documents/IUC5-3e2caede-4400-415d-aeea-5410f0c935b1_d3099007-333f-4b70-a5fd-640a849f8e1f.html,,,,,, Nα-acetyl-DL-tryptophan,87-32-1," Oral, rat: NOAEL = 2500 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/954ad3d8-39fd-4a47-bfe9-70b6e77c0d36/documents/048bdd7b-9b4f-4ce8-b916-ea4b2281f8e4_2f8f4acb-1213-4b1d-99fa-125fc709bf7b.html,,,,,, Nα-acetyl-DL-tryptophan,87-32-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/954ad3d8-39fd-4a47-bfe9-70b6e77c0d36/documents/048bdd7b-9b4f-4ce8-b916-ea4b2281f8e4_2f8f4acb-1213-4b1d-99fa-125fc709bf7b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"2,500 mg/kg bw/day",,rat Nα-acetyl-DL-tryptophan,87-32-1," Oral, (10-day developmental toxicity study): LD50 > 5000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/954ad3d8-39fd-4a47-bfe9-70b6e77c0d36/documents/8b8fc013-55ab-4419-a670-ace0bb9bfbb9_2f8f4acb-1213-4b1d-99fa-125fc709bf7b.html,,,,,, "O-(2-ethylhexyl) O,O-tert-pentyl peroxycarbonate",70833-40-8," A repeat dose study in rats was conducted in rats orally dosed with the test item for 4 weeks (OECD 407). In this GLP subacute toxicity study, effects were seen in liver, forestomach, and in kidney. Slightly elevated liver weights noted in the females treated with 300 or 1000 mg/kg/day were considered to be adaptive, non-adverse changes of metabolic origin. Forestomach mucosal necrosis was recorded in males treated with 100 mg/kg/day and both sexes treated with 300 mg/kg/day and 1000 mg/kg/day. The microscopic effects on the forestomach were considered to be local injuries that resulted in subsequent adverse reactions. Increased severity of hyaline droplets in the renal proximal tubules in males treated with 1000 mg/kg/day. This was considered to be a protein specific to male rats similar to alpha-2 microglobulin, and generally derived from hyperfunction of the liver. Although this is considered to be an adverse finding in rats, this protein has no counterpart in humans and is therefore of no toxicological relevance. The no-observed-effect-level (NOEL) and the local no-observed-adverse-effect-level (NOAEL) were considered to be below 100 mg/kg/day, based on the adverse irritative findings in the forestomach. However, the no-observed-adverse-effect-level (NOAEL) for systemic toxicityof O-(2-ethylhexyl) O,O-tert-pentyl peroxycarbonate was considered to be 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a59ea27-600d-4e29-b4cb-0483bf3f04aa/documents/350fc943-c108-4ac4-8b17-1255c34e9fec_ea3faa71-f5af-4060-9944-daa0a8b78863.html,,,,,, "O-(2-ethylhexyl) O,O-tert-pentyl peroxycarbonate",70833-40-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a59ea27-600d-4e29-b4cb-0483bf3f04aa/documents/350fc943-c108-4ac4-8b17-1255c34e9fec_ea3faa71-f5af-4060-9944-daa0a8b78863.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "O-(2-ethylhexyl) O,O-tert-pentyl peroxycarbonate",70833-40-8," Acute Oral Toxicity: A group of Sprague-Dawley rats (5 males and 5 females, each) received a single oral dose of tert. amylperoxy-2- ethylhexylcarbonate at 5000 mg/kg body weight. No mortalities occurred and, with exception of occasional diarrhoea in the beginning of the study, no signs of systemic toxicity were observed during the 14-day observation period. Weekly group mean body weight gain was normal. There was no evident sex related effect. Macroscopic examination of all animals at the end of the study revealed no test substance related gross abnormalities. Since no mortalities occurred, the LD50 value for males and females combined was estimated to exceed 5.0 g/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a59ea27-600d-4e29-b4cb-0483bf3f04aa/documents/c683e0d6-6849-4672-8c97-1b2bd89f16dd_ea3faa71-f5af-4060-9944-daa0a8b78863.html,,,,,, "O-(2-ethylhexyl) O,O-tert-pentyl peroxycarbonate",70833-40-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a59ea27-600d-4e29-b4cb-0483bf3f04aa/documents/c683e0d6-6849-4672-8c97-1b2bd89f16dd_ea3faa71-f5af-4060-9944-daa0a8b78863.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "O-(2-ethylhexyl) O,O-tert-pentyl peroxycarbonate",70833-40-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a59ea27-600d-4e29-b4cb-0483bf3f04aa/documents/c683e0d6-6849-4672-8c97-1b2bd89f16dd_ea3faa71-f5af-4060-9944-daa0a8b78863.html,,dermal,discriminating dose,"2,000 mg/kg bw",, O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate,41198-08-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d6d6cd98-974f-43f5-8a0f-08a3797e05f6/documents/IUC5-e34fae65-f0bb-43ca-9a34-00829881b174_c45d92fd-37c4-495e-9cad-cc697c14fbb5.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,2.5 mg/kg bw/day,,rabbit O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate,41198-08-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d6d6cd98-974f-43f5-8a0f-08a3797e05f6/documents/IUC5-e34fae65-f0bb-43ca-9a34-00829881b174_c45d92fd-37c4-495e-9cad-cc697c14fbb5.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,68 mg/m3,,rat O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate,41198-08-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d6d6cd98-974f-43f5-8a0f-08a3797e05f6/documents/IUC5-e34fae65-f0bb-43ca-9a34-00829881b174_c45d92fd-37c4-495e-9cad-cc697c14fbb5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,12.5 mg/kg bw/day,,dog O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate,41198-08-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6d6cd98-974f-43f5-8a0f-08a3797e05f6/documents/IUC5-323536ca-bf0e-474d-bdf0-bf2837ff412d_c45d92fd-37c4-495e-9cad-cc697c14fbb5.html,,oral,LD50,620.5 mg/kg bw,adverse effect observed, O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate,41198-08-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6d6cd98-974f-43f5-8a0f-08a3797e05f6/documents/IUC5-323536ca-bf0e-474d-bdf0-bf2837ff412d_c45d92fd-37c4-495e-9cad-cc697c14fbb5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, O-(4-bromo-2-chlorophenyl) O-ethyl S-propyl phosphorothioate,41198-08-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d6d6cd98-974f-43f5-8a0f-08a3797e05f6/documents/IUC5-323536ca-bf0e-474d-bdf0-bf2837ff412d_c45d92fd-37c4-495e-9cad-cc697c14fbb5.html,,inhalation,LC50,220 mg/m3,adverse effect observed, O-(ethoxycarbonyl)-N-(1-methyl-2-oxo-2-phenylethylidene)hydroxylamine,65894-76-0," Under the conditions of this study, the acute oral LD50 value in female Wistar rats was greater than 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86309af0-a9a5-4ac5-b1a2-da7afb560094/documents/9442486d-f652-492b-bab5-d7363b151602_3769aa2a-7354-4b61-8822-1cc240a449e0.html,,,,,, O-(ethoxycarbonyl)-N-(1-methyl-2-oxo-2-phenylethylidene)hydroxylamine,65894-76-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86309af0-a9a5-4ac5-b1a2-da7afb560094/documents/9442486d-f652-492b-bab5-d7363b151602_3769aa2a-7354-4b61-8822-1cc240a449e0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, o-(p-isocyanatobenzyl)phenyl isocyanate,5873-54-1,"Description of Key information The test substance is part of a category approach of methylenediphenyl diisocyanates (MDI) with existing data gaps filled according to ECHA guidance on Read Across (ECHA, 2017).  The read-across category justification document is attached in IUCLID section 13 and summarized below in Additional Informaiton.  Data-gaps in this endpoint is satisfied by weight of evidence and read across from valid repeated dose toxicity studies for the inhalation route. Reliable repeated dose inhalation data in animals is available for the boundary substances (4,4’-MDI, pMDI and 4,4’-MDI/DPG/HMWP). The chronic repeated dose toxicity study (Reuzel et al. 1994, reliability 2) performed with pMDI is a guideline study (OECD 451). In addition, valid sub-chronic and sub-acute repeated dose toxicity studies are available  for pMDI (Reuzel et al. 1994, Kilgour et al. 2002, reliability 2). For the 4,4’-MDI a valid chronic inhalation toxicity study is available (Hoymann et al. 1995, reliability 2) and a limited documented sub-chronic inhalation toxicity study (Heinrich et al. 1991, reliability 4). For the boundary substance 4,4’-MDI/DPG/HMWP a sub-acute toxicity study is available (Ma-Hock, 2021, reliability 1).   Proposed Testing: To support this weight of evidence and read across approach additional repeated dose toxicity testing is planned. It is considered to perform a sub-chronic inhalation toxicity study (OECD 413) with boundary substance 4,4’-MDI/DPG/HMWP. Additional, combined Repeated Dose Toxicity studies with Reproductive/ developmental Toxicity Screening tests (OECD 422) will be performed on 9 substances representing all sub-groups and key structural/chemical characteristics (see overview attached in Annex 27 in Chapter 13). These screening studies will confirm the proposed MoA on repeated dose toxicity or identify substances that may require additional testing.   Available information: Several sub-acute, sub-chronic and chronic studies have been performed on 4,4’-MDI, pMDI and 4,4’-MDI/DPG/HMWP and are described in Category justification document in Chapter 13 . A repeated dose dermal toxicity study was performed in rabbits with pMDI (Wazeter et al., 1964a) but since this only has fourteen days of treatment and only slight local skin irritants effects were observed this is omitted from this chapter, but rather described in chapter addressing skin irritation. As with the acute studies, in all repeated dose studies, toxic effects were limited to the site of contact with no systemic effects observed distant from the portal of entry. Key repeated dose studies days are described below:  The ‘Monomeric MDI’ subgroup In a subchronic inhalation study with 4,4’-MDI, female Wistar rats were exposed to concentrations of MDI of 0, 0.3, 1 or 3 mg 4,4’-MDI/m3 for 18 hours a day on 5 days a week for 13-weeks. Reduced body weight gains and an increase in relative lung weights were found at 1 mg/m3 and above. At and above this concentration infiltration of mononuclear cells, goblet cell hyperplasia, erosion of the respiratory epithelium in the upper respiratory tract, hyperplasia of the bronchus-associated lymphatic tissue and inflammatory changes of the lung were additionally observed. At 3 mg/m3 there was an increase in the total cell count and proportion of granulocytes and lymphocytes, a decrease in the proportion of macrophages in the bronchoalveolar lavage fluid, an increase in protein, β-glucuronides and lactate dehydrogenase, and changes in lung function. No effects were observed at 0.3 mg/m3 (Heinrich et al., 1991). A subsequent chronic inhalation study (Hoymann et al., 1995) was conducted with 4,4’-MDI. Female Wistar rats were exposed to 0.23, 0.70 or 2.05 mg 4,4’-MDI/m³ aerosols for 17 hours/day, 5 days /week for up to 24 months. Essentially, a dose-dependent impairment of the lung function in terms of an obstructive-restrictive malfunction with diffusion disorder, increased lung weights, an inflammatory reaction with increased appearance of lymphocytes in the lung in the high dose group as a sign of specific stimulation of the immune system by MDI, an intermediately retarded lung clearance in the high dose group as well as dose-dependent interstitial and peribronchiolar fibrosis, alveolar bronchiolisations and a proliferation of the alveolar epithelium, which was classified as preneoplastic, as well as a bronchiolo-alveolar adenoma were identified. The LOAEC for the female rat was identified as 0.23 mg/m3 based on minor histopathological pulmonary lesions after long-term inhalation of 4,4'-MDI aerosols.  A comparison of the pulmonary effects described in female rats from the two chronic studies, one with 4,4’-MDI and the other with pMDI, was published by Feron et al. (2001). To assist the comparison and account for the lower proportion of mMDI in pMDI, the authors normalized the different MDI doses to total inhalation exposures calculated as 559; 1,972; 2,881; 6,001; 17,575 and 17,728 mg mMDI.h/m3. The major pulmonary effects in the two studies were characterized by hyperplasia, interstitial fibrosis and a low incidence of bronchiolo-alveolar adenoma, the latter occurring in the high exposure groups of both studies (i.e. total inhalation exposures of 17,728 and 17,575 mg.h/m3). Both studies also reported the presence of particle-laden macrophages predominantly in the alveoli close to the alveolar ducts which in some cases, particularly in high dose groups, were associated with areas of fibrosis. There was a clear quantitative dose response in both studies with the lowest dose of 559 mg mMDI.h/m3 from the study reported by Reuzel et al. (1994a) being described as the no-observed-adverse-effect-level (NOAEL) Feron et al. (2001) also suggested that the mild histopathological changes seen in the low exposure animals (0.23 mg/m3) in the Hoymann et al. (1995) study, would not have occurred if the exposure had been for six hours/day. An exposure of 0.2 mg/m3 over a six-hour period was judged to be the NOAEL in both studies. Overall, the analysis concluded that both studies showed similar qualitative responses to exposures to pMDI or 4,4’-MDI when compared on the basis of mMDI content..  The ‘Oligomeric MDI’ subgroup In a subacute inhalation study by Kilgour et al. (2002), female Alpk:APfSD rats were exposed to pMDI aerosol at  concentrations of 0, 1.0, 4.0 and 10 mg pMDI/m3, for 6 hours/day, 5 days/week, for  28 days, a 30-day recovery group was included. No clinical signs were noted during exposure and recovery phase. Body weights in all groups were comparable to controls throughout exposure and recovery periods. Lung weights were increased in animals exposed to 10 mg/m3 at the end of the exposure period, although this had returned to control values by day 30 post-exposure. Lung weights of all other treated groups were in the range of the control group. A dose-dependent influx of inflammatory cells, total protein levels and increase in enzyme activities indicated an inflammatory reaction. A statistically significant increase in both the total number of cells counted and alveolar macrophages in lavage fluid was noted at 10 mg/m3, and a slight (but not statistically significant) following exposure to 4 mg/m3. The polymorphonulear leukocytes (PMNs) and lymphocyte/other cells showed statistically significant, concentration-related increases in cell counts following exposure to 4 or 10 mg/m3 pMDI. At the end of the recovery phase, cell counts in exposed animals had returned to normal. Animals of the exposure groups 4 and 10 mg/m3 showed an increase of macrophages containing vacuoles (foamy macrophages), whereas the 1 mg/m3 group was in the range of the control animals. At the end of the recovery period few macrophages vacuoles were still discernable. In animal exposed to 10 mg/m3 pMDI a statistically significant increase in total protein and alkaline phosphatase activity was noted in lavage fluid at the end of exposure, whereas lactate dehydrogenase and N-acetyl glucosaminidase (NAG) activities were not increased. All other treated groups in the main study and all groups at the end of the recovery phase showed values similar to controls. A transient increase in phospholipids concentration was noted in the lavage fluid from animals exposed to 10 mg/m3 pMDI after exposure, no differences from control values were seen at the end of the recovery phase. In all exposure groups a statistically significant concentration-related increase in BrdU labelling index in terminal bronchioles were seen; a similar increase in centro-acinar alveoli were found in animals exposed to 4 and 10 mg/m3 pMDI. At the end of the recovery phase, labelling indices were similar to control values at all concentrations. No macroscopic abnormalities were noted. Histopathology of the lung showed in animals exposed to 10 mg/m3 pMDI an increase in bronchiolitis and thickening of the centro-acinar region, interstitial thickening at the acinar junctions, and accumulations of alveolar macrophages containing yellow pigment in the cytoplasm. In animals exposed to 4 mg/m3 pMDI 1/5 animals showed thickening of the centro-acinar region and bronchiolitis and 1/5 animals exposed to 1 mg/m3 pMDI showed bronchiolitis. After the recovery phase, alveolar macrophages containing a yellow pigment were present in the interstitium in all animals that had been exposed to 10 mg//m3 pMDI but were absent in animals exposed to 1 or 4 mg/m3 pMDI. In addition, 1/5 animals exposed to 10 mg/m3 pMDI still had bronchiolitis and centro-acinar thickening, but at a reduced severity and distribution to that seen in the main study. Ultrastructural findings suggest a perturbation of surfactant homeostasis by exposure to pMDI which is supported by the small increase in measured phospholipids and observation of foamy macrophages. Animals exposed to 10 mg/m3 pMDI showed a slight thickening of the interstitial alveolar wall in 3/5 animals. The thickening in the centro-acinar region was due to thickening of the interstitium, which partly attributable to the absorption of alveolar macrophages and partly due to excess collagen. Compound -related increases in the levels of surfactant were noted in the alveolar macrophages and lumina. In the alveolar macrophages, minimal to slight increases in lamellar surfactant were associated with minimal and moderate increases in amorphous surfactant in animals exposed to 10 mg/m3 pMDI.  In the alveolar lumina, minimal to moderate increase in cell debris were noted in animals exposed to 10 or 4 mg/m3 pMDI. Associated with these increases in cell debris were increases in the amount of crystalline and lamellar surfactant. At 1 mg/m3 there was evidence of effect on surfactant homeostasis, with small increase in number and size of type II cell lamellar bodies and similar increases in  amorphous, crystalline and lamellar surfactant in the  alveolar lumina, which was seen as an adaptive response to exposure to low levels of irritant aerosol. Based on findings of histopathology, bronchiolitis noted at 1 mg/m3 and evidence of effect on surfactant homeostasis at 1 mg/m3, NOAEC could not be defined and the LOAEC was set at 1 mg/m3 pMDI.   In a subchronic inhalation study (SC1) by Reuzel et al. (1994b) (original report Reuzel et al. (1985)) Wistar rats were exposed to pMDI aerosol at concentrations of 0, 0.35, 1.4 and 7.2 mg pMDI/m3, for 6 hours/day, 5 days/week over a period of 13 weeks. Transient slight growth retardation was observed in male rats exposed to 7.2 mg/m3 air. Haematology, blood chemistry and urinalysis did not show treatment-related effects. There were no significant differences in organ weights between the test and control groups. Gross examination at autopsy did not reveal changes which could be ascribed to the test substance. Histopathological examination revealed yellow material (possibly polyurea originated from test material) in the respiratory tract of rats exposed to 7.2 mg/m3. Under the conditions of this test no clear NOAEC was determined. In an associated second subchronic study (SC2) by Reuzel et al. (1994b) (original report by (Reuzel et al., 1986)), Wistar rats were exposed to higher aerosol concentrations of 4.1, 8.4 and 12.3 mg pMDI /m3 air for 3-months. Severe respiratory distress was observed in rats exposed to 12.3 mg/m3 with 11 males and 4 females dying during the exposure period. Significantly less severe signs were seen in rats exposed to 8.4 mg/m3. This study demonstrated adverse effects in the lungs and nasal cavity at levels of 4.1 mg/m3 and above and included histological effects in the lungs (increase in alveolar macrophages and interstitial macrophage infiltration) and in the mediastinal lymph nodes (macrophages with yellowish inclusions). At 8.4 mg/m³ and above increased relative lung weights, partially reversible damage to the olfactory epithelium and basal cell hyperplasia were observed.   In a combined chronic toxicity and carcinogenicity key study (Reuzel et al., 1990; Reuzel et al., 1994a) conducted according to OECD Guideline 453 rats were exposed for 6 hours/day, 5 days/week for one year (satellite groups) or two years (main groups) to aerosol concentrations of 0, 0.2, 1.0 or 6.0 mg pMDI /m3 (analytical concentrations: 0, 0.19, 0.98, 6.03 mg/m3). The effect of chronic exposure of rats to respirable pMDI aerosol was confined to the respiratory tract. The compound-related changes were found in the nasal cavity, the lungs and the mediastinal lymph nodes, and to some degree they were already present after one year of exposure. Histopathology of the organs/tissues investigated showed that exposure to 6.0 mg/m3 over two years was related to the occurrence of pulmonary tumors in males (6 adenomas and 1 adenocarcinoma) and females (2 adenomas). In this two-year rat study, the NOAEC was 0.2 mg/m3 for the repeated dose toxicity of pMDI. The LOAEC was set at 1.0 mg/m3.   The ‘MDI and its reaction products with glycols’ subgroup Pre-liminary results are available for a subacute inhalation study (Ma-Hock, 2021) which was conducted according to OECD 412 on 4,4’-MDI/DPG/HMWP. This study was designed as closely as possible to the study described above by Kilgour et al. (2002) on pMDI to generated comparable data on 2 category boundary substances.  A qualitative and quantitative comparison between these studies will be described in more detail in the category justification document attached to this dossier.   Male and female Wistar rats (7 animals per sex and exposure group) were exposed to 4,4’-MDI/DPG/HMWP liquid aerosol at  concentrations of 0, 1.0, 4.0 and 10 mg/m3 (analytical conc.: 0, 1.0, 3.9 and 9.8 mg/m3), for 6 hours/day, 5 days/week, for  4 weeks (main study). To evaluate the reversibility of effects, 28-day recovery groups were included (recovery control group and 10 mg/m3 exposure group). No mortality was observed throughout the study. During the exposure period clinical signs like respiration sound and piloerection were noted in animals exposed to 10 mg/m3 and one animal exposed to 4 mg/m3. In all other animals, no clinical signs were observed during the exposure period. No clinical signs were observed during the recovery period. Body weights of males exposed to 10 mg/m3 was slightly lower throughout the exposure period but were in the range of the concurrent control at the end of the recovery period. All other groups were comparable throughout exposure and recovery period. A significant increase in mean relative lung weights was observed in males and females of the 10 mg/m3 exposure group, although this had returned to control values at the end of the recovery period. Regarding clinical chemistry, one female of exposure group 4 mg/m3 and 2 females of exposure group 10 mg/m3 (main study) showed an increase in serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) activities. These effects were regarded as caused by the implant of Alzet osmotic minipumps, thus regarded as treatment related but not substance related effect. All other changes in clinical chemistry observed in exposed animals were regarded as incidental and not treatment related. In animals exposed to 10 mg/m3 a lymphocytic-monocytic inflammation was observed indicated by increased total cell counts as well as absolute and relative lymphocyte and monocyte counts. This type of inflammation was confirmed by marginal, non-relevant increases of lactate dehydrogenase (LDH BAL) and alkaline phosphatase (ALP BAL) activities, but relevantly, slight increases of γ-glutamyl transferase (GGT BAL) activities among these individuals. In BAL of rats exposed to 10 mg/m3 increases of high total protein levels were observed. At the end of the recovery period total protein levels and enzyme activities and cell counts had returned to control levels. Treatment-related histopathological findings were observed in lungs, trachea, larynx, tracheobronchial lymph nodes and mediastinal lymph nodes in male and female animals. Interstitial inflammation of the terminal bronchi was observed in animals exposed to 4 mg/m3 and 10 mg/m3. Hypertrophy/hyperplasia of large, medium and terminal bronchi were observed in animals exposed to 4 mg/m3 and 10 mg/m3, which was associated with an increase in cell proliferation, indicated as a significant increase in BrdU labeling indices. A statistically significantly increased cell proliferation was also observed in animals exposed to 1 mg/m3 in large, medium and terminal bronchi. In alveoli there was a trend towards increased cell proliferation, however there was no dose-response relationship, statistically significance was only seen in males exposed to 10 mg/m3. Pneumocytes type II cells showed minimal proliferation in few animals of the 4 mg/m3 and 10 mg/m3 exposure group. Interstitial inflammation of alveoli was noted in males of the 4 mg/m3 and 10 mg/m3 exposure groups. In the alveolar lumina, neutrophilic infiltration was found occasionally. Debris was seen in one male of the 4 mg/m3 exposure group in alveolar lumina consisting of fragments of cells. Alveolar macrophage accumulation was seen with increased severity in males and females exposed to 10 mg/m3. A minimal increase in alveolar macrophages was still present in females at the end of the recovery period. Macrophages with foamy cytoplasm (foamy macrophages) were observed in males of the 4 mg/m3 and 10 mg/m3 exposure groups and in females exposed to 10 mg/m3. Epithelial alteration in the larynx was noted with increased incidence and severity in treated animals and was characterized by a focal, ventrally located change of the epithelium from cuboidal to focally flattened cells and was noted with increased incidence and severity in treated animals. Lymphocyte infiltration was seen in the submucosa in treated animals. The trachea epithelium on the tip of the carina was changed from its normal cuboidal, ciliated appearance to a single layer of flattened cells with loss of cilia in treated animals. Hyperplasia of the trachea epithelium was seen in males exposed to 4 mg/m3 and 10 mg/m3 and females exposed to 10 mg/m3. Beneath the epithelium, there was an increased infiltration of lymphocytes in single animals. A diffuse enlargement of mediastinal and tracheobronchial lymph nodes was seen in treated animals. The histopathological changes noted after termination of exposure were mostly reversible. An increased incidence of minimal alveolar macrophage accumulation was still observed at the end of the recovery period in treated females. Increased cell proliferation in alveoli was still observed in treated males. No other treatment related findings were observed at the end of the recovery period.   In summary, substance-related systemic effect was not observed. Under the current study conditions, the no observed adverse effect level (NOAEL) for systemic toxicity was 10 mg/m³. The NOAEL for local toxicity could not be established due to the slight changes in labeling indices present at 1 mg/m³ (Ma-Hock, 2021).   Human information A large dataset is available in human epidemiological and case studies for chronic exposure to diisocyanates in the workplace and reported effects are limited to respiratory system. Effects associated with respiratory sensitization are described in chapter sensitization and potential carcinogenicity is described in carcinogenicity chapter. In general, long term exposure to MDI substances can result in non-immunological decreases in lung function and other respiratory symptoms associated with chronic irritation. Interpretation of many of these studies is confounded by simultaneous exposure to TDI and inaccurate exposure data. Despite these limitations, pMDI concentrations as low as 87 ppb (0.9 mg/m3) were shown to correlate with deterioration in lung function whereas when exposures were below a maximum concentration of 20 ppb (0.2 mg/m3), no significant changes in lung spirometry was generally observed (DFG, 2008). The frequency of respiratory complaints was not significantly increased when exposure levels were below 10 ppb (0.1 mg/m3) (DFG, 2008).     Justification for selection of repeated dose toxicity inhalation - systemic effects endpoint: No system toxicity up to the highest dose group tested   Inhalation is the most appropriate route of exposure for assessing occupational risk of substances of the MDI category in humans. Repeated dose studies are available for the three boundary substances , GLP compliant study on both 4,4’-MDI and pMDI with reliability 2, conducted according to OECD Guideline 453 (combined chronic toxicity/carcinogenicity studies) and two 28 day studies on pMDI and 4,4’-MDI/DEG/HMWP. In all repeated dose studies, toxic effects were limited to the site of contact with no systemic effects observed distant from the portal of entry, which is in line with the discussed MoA of MDI toxicity (see category justification document).   Repeated dose toxicity: inhalation - local effects (target organ) respiratory: respiratory tract   ​ Inhalation is the most appropriate route of exposure for assessing occupational risk of substances of the MDI category in humans. Repeated dose studies are available for the three boundary substances, GLP compliant study on both 4,4’-MDI and pMDI with reliability 2, conducted according to OECD Guideline 453 (combined chronic toxicity/carcinogenicity studies) and two 28 day studies on pMDI and 4,4’-MDI/DEG/HMWP. Consistent with the hypothesized MoA proposed (see category justification document) for these substances the primary health effect following inhalation exposure is local irritation within the respiratory tract without significant systemic exposure or toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b09ebd51-7f02-4f82-8dbb-f26edf22a42f/documents/3c2aa6cb-5926-4781-bf26-ff77265a67f0_98b78b77-0045-4727-ac7c-c68d539d05a8.html,,,,,, o-(p-isocyanatobenzyl)phenyl isocyanate,5873-54-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b09ebd51-7f02-4f82-8dbb-f26edf22a42f/documents/3c2aa6cb-5926-4781-bf26-ff77265a67f0_98b78b77-0045-4727-ac7c-c68d539d05a8.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1 mg/m3,adverse effect observed, o-(p-isocyanatobenzyl)phenyl isocyanate,5873-54-1,"Data gap filling for the acute inhalation toxicity endpoint is achieved using the category approach according to ECHA guidance on read-across (ECHA, 2017c). For this endpoint, all effects are consistent with the hypothesized MoA and direct electrophilic reactions of NCO with biological nucleophiles. Modified MDI substances contain different higher molecular weight constituents, and all have in common a high content of bioaccessible low molecular weight MDI constituents responsible for presenting NCO reactivity, scenario 4 or 6 according to the RAAF considered as most appropriate due to a common mechanism. Selection between scenario 4 and 6 depends essentially upon the presence of variation in the properties i.e. magnitude of effect. Since it has been demonstrated that the bioaccessible low molecular weight MDI constituents are responsible for presenting NCO reactivity, and the higher molecular weight MDI constituents do not contribute to the observed toxicity it is reasonable to assume that their presence in these mixtures attenuates toxicity. Further, as a worst-case approach is adopted in which 4,4’-MDI isomer is used for read-across to all substances of the MDI category, then use of RAAF Scenario 4 (variations in the properties observed among source substances) is justified over scenario 6.   Acute oral toxicity In the case of oral exposure, before the reactive NCO groups present on the substances of the MDI category have opportunity to react locally, or be absorbed, they polymerize in the acid environment of the stomach to form solid polyureas that are excreted via the feces without being absorbed. Consequently, if exposure were to occur by the oral route this would not lead to local or systemic effects. For MDI Mixed Isomers, the key study (Reliability 1) did not record mortality up to the limit dose of 2,000 mg/kg bw . A supporting study describing the acute oral toxicity of pMDI conducted similar to OECD 401 guideline (Reliability 2) also did not find any mortality up to the maximum dose tested, hence the LD50 is greater than 10,000 mg/kg bw . Other studies on MDI substances are consistent with this, albeit with lower reliability.  Four additional acute oral toxicity studies (Reliability 1) have been conducted on other representative substances of the category subgroups (i.e. ‘MDI, its condensation products and the reaction products with glycols’ and ‘MDI and its reaction products with glycols’). In all cases, there was no mortality up to the limit dose (5,000 mg/kg). The lack of mortality in the available acute oral toxicity across the available studies, alongside the lack of gross lesions in distal tissues (e.g. liver, kidney etc.) supports the lack of systemic bioavailability. The NCO groups present on MDI substances react with acids within the stomach leading to formation of an insoluble polymerized mass that is excreted in the feces without being absorbed (see Toxicokinetics).  Supporting evidence comes in the form of several accidental ingestion reports in dogs where ingestion of MDI based glues produced no intrinsic toxic effects other than the formation of a solid polyurea mass that may lead to gastric obstruction. When the mass was removed by surgery, rapid and complete recovery was achieved (Horstman et al., 2003; Ohngren, 2007).     Acute dermal toxicity In the case of dermal exposure, before the reactive NCO groups present on MDI substances have opportunity to be absorbed to any significant extent through the stratum corneum they react with proteins and moisture at the skin surface leading to the formation of an insoluble polymerized mass thereby limiting dermal absorption and systemic availability (Leibold 1999). Modified MDI substances, having a higher molecular weight than mMDI isomers and due to their higher molecular volume, increased octanol-water partition coefficient and decreased water solubility will in any event not be able to penetrate the stratum corneum (Bartels 2021). The available acute dermal toxicity studies indicate that all substances of the MDI category have low acute dermal toxicity. The key study describing the acute dermal toxicity of pMDI in rabbits did not find lethality up to the maximum dose tested, and the LD50 was greater than 9,400 mg/kg bw (Wazeter et al., 1964a). Other less reliable studies on pMDI or 4,4’-MDI are consistent with this.  Observed differences in LD50 values between pMDI and 4,4'-MDI/TPG are not considered to be significant or represent a trend since they are significantly higher than the limit for classification and are indicative of a lack of systemic exposure. The available data for the substances of the MDI category is consistent with the hypothesis that NCO groups present on MDI substances react with proteins and moisture at the skin surface leading to the formation of an insoluble polymerized mass resulting in limited dermal absorption and systemic availability. The available data and hypothesis is supported by the key dermal absorption study that shows that MDI substances have very low systemic bioavailability (<1 %) (Leibold et al., 1999). By comparison, modified MDI substances, with molecular weight greater than mMDI, will demonstrate even further reduced dermal absorption based upon physico-chemical properties (i.e. increased octanol-water partition coefficient, decreased water solubility, and increased molecular weight), and this has been confirmed with GastroPlus™ modeling (Bartels, 2021). Although a reliable, acute dermal in vivo toxicity data is only available on two category substances, it is considered sufficient for assessment of this endpoint for the category. Due to the low predicted dermal bioavailability of all category substances, and the lack of systemic toxicity demonstrated in the oral acute toxicity studies, additional testing is not justified as all substances of the MDI category would be predicted to have comparable or reduced acute dermal toxicity potential to tested substances.   Acute Inhalation Toxicity Following inhalation exposure the initiating event in hypothesised MoA for acute toxicity in the lung is the reaction of the MDI substance with GSH in the airway lining fluid (adduct formation). Subsequent development of toxic effects is driven by the rate of depletion of GSH. This depletion begins with the reduction in extracellular GSH, which leads to a reduction in intracellular GSH disturbing the redox balance in the cell. With increasing amounts of NCO exposure (e.g. via exposure concentration or bioaccessibility), the protective GSH system gradually becomes overwhelmed, and toxicity evolves along the path: (1) no cytotoxicity; (2) cytotoxic effects; (3) reduced cell viability; and (4) cell death. This is accompanied by increasing extravasation because of increased junction permeability and epithelial damage ultimately causing edema.    The rate of nucleophile depletion by MDI-based substances is driven by the availability of the NCO-group, which itself is a function of (1) the NCO value of the substance and (2) the molecular weight of its constituents (driving its reactive dissolution). Monomeric MDI isomers have been shown to become available at a similar rate in toxicokinetic studies (Wisnewski, 2018; Wisnewski et al., 2019a) which is consistent with the generally comparable LC50 values for all of the isomers. Conversely, higher molecular weight constituents have both a reduced NCO value and exhibit reduced water solubility, making them less accessible to react with GSH. Therefore, the substances with the highest available NCO value and bioaccessibility (mMDI and three-ring oligomers) are the most toxic, while those with increasing amounts constituents less able to react with GHS demonstrate reduced toxicity.   Tests also show that toxicity is limited to portal-of-entry effects. The absence of systemic toxicity is due to the extracellular reactions described above, combined with transcarbamoylation to proteins described in more detail in the Chapter (Toxicokinetics), constitute a detoxification mechanism. Acute toxicity is only observed when this protective mechanism becomes overwhelmed and is limited to the lung. This mode of action is supported with high confidence by reliable acute inhalation data available for multiple MDI isomers and modified MDI substances (described in more detail below). The toxicity of MDI substances will decrease with increasing average molecular weight as these substances will have constituents that are less bioaccessible and with a lower NCO value. For these substances, higher exposure concentration is required to induce toxic effects, which is consistent with the observed results from the available acute inhalation toxicity tests.  Testing proposal: While testing is available on 8 MDI category memeber (including all sub-groups) acute toxicity testing (OECD 403) will be performed on an additional 4 MDI substances.  This information will further support the category hypothesis as well as help to define substance selection and study design for repeat-dose bridging studies.    Available data: The ‘Monomeric MDI’ subgroup Reliable acute inhalation studies are available for all three isomers of mMDI (2,2’-; 2,4’-; and 4,4’-MDI) in accordance with OECD Guideline 403 in a series of studies by (Pauluhn, 2008d; Pauluhn, 2008e; Pauluhn, 2008f). All three substances consist of more than 98 % pure mMDI, corresponding to NCO value of 33%. In all cases, mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA. LC50s were comparable and ranged from 368 to 598 mg/m3 for males and from 559 to 686 mg/m3 for females. For all studies, exposure parameters met internationally recognized recommendations for MMAD and GSD and were similar for all three isomers. The ‘Oligomeric MDI’ subgroup Polymeric MDI (approximately 40 % mMDI; 33 % NCO value, with viscosity of approximately 200 mPas) was tested in an acute inhalation toxicity study according to OECD 403 (Pauluhn, 2008c). Mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA. An LC50 (95 % confidence interval) of 310.2 (266.4-361.3) mg/m3 was determined for pMDI.  Polymeric MDI was also tested following depletion of monomeric MDI resulting in a mixture of 1.2 % mMDI and 98.8 % of higher (> two-ring) oligomers according to OECD 403 (Pauluhn, 2011a). The combined LC50, for male and female rats, for ‘monomer-depleted pMDI’ was greater than 2,188 mg/m3. Average mean mass aerodynamic diameter (MMAD) and geometric standard deviation (GSD) was generally comparable to that of the pMDI containing mMDI (85-87 %). The ‘MDI and its condensation products’ subgroup The acute inhalation toxicity of MDI Mixed isomers/PIR (60 % mMDI and NCO value of 26 %) was tested in an acute inhalation toxicity study according to OECD 403 (Pauluhn, 2012). The combined LC50 for male and female rats was 1,088 mg/m3, mortality was linked to portal of entry effects of the respiratory system, including severe irritation and pulmonary edema. Mortality occurred up to two days post-exposure and was causally related to an acute pulmonary edema. The ‘MDI and its reaction products with glycols’ subgroup Two reliable acute inhalation studies are available for substances of the ‘MDI and its reaction products with glycols’ subgroup. The acute inhalation toxicity of 4,4'-MDI/1,3-BD/TPG/PG (60 % mMDI; 23 % NCO) was conducted according with OECD 403 (Kopf, 2016).  The LC50 was calculated to be 518 mg/m3, and mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA.  The acute inhalation study of 4,4'-MDI/DPG/HMWP (50 % mMDI; 25 % NCO) was tested according to OECD 403 (Hotchkiss and Weidemoyer, 2020). The LC50 is 1,110 mg/m3 for male rats and 1,250 mg/m3 for female rats. The four-hour LC50 is 1.15 mg/L for male and female rats combined. Similar to the other LC50 studies, mortality was linked to local effects of the respiratory system that included severe irritation, pulmonary edema, and ultimately death occurring within one to two days following exposure consistent with the hypothesized MoA.   An acute inhalation study was performed in rats at only one concentration level of 2.24 mg/L/1h (Pauluhn 2003, 2004). This study was specifically designed to comply with NFPA 704, and also complied with the limit test of the OECD guideline 403 with deviations (only 1 hr exposure, concentration lower than limit test concentration) and is therefore reliable with restrictions. Exposure of 4,4’-MDI for 1 hr resulted in mortality shortly after exposure of one out of ten rats. Clinical signs were characterised by typical signs of respiratory tract irritation. Necropsy findings were unremarkable in surviving rats, whilst the rat that succumbed displayed signs of lung oedema which was considered to be the cause of death. The LC50 >2.24 mg/L/1h (analytical) in both males and females was determined.        Adequacy of the available data for risk assessment and classification purposes Using the strict GHS LC50 cut-off for classification, the LC50 values obtained for the mMDI would trigger a Category 2 (or Category 3) according to GHS CLP. However, classification for these substances according to ECHA CLP Guidance (2017) text allows for the application of scientific judgement. It must be considered that the LC50 cut-off of 500 mg/m3 (approximately 50 ppm for pMDI), is over 2,500-fold above the saturated vapor concentration for pMDI. This difference is even further exacerbated in the pre-polymer mixtures where the presence of the higher molecular weight fraction even further reduces the vapor pressure making exposure less likely.    Furthermore, the aerosols were generated using sophisticated techniques in the laboratory, whereby extremely small particles are generated in order to meet international guidelines for testing. This size and concentration of aerosol is not generated in the workplace even under foreseeable worst-case conditions (Ehnes et al., 2019). The particle size distribution of aerosols formed during actual spraying applications has virtually no overlap with that of the highly respirable aerosol generated in inhalation studies (see EC (2005)). Due to a very low vapor pressure (<0.01 Pa) MDI substances are not inherently toxic by inhalation since the saturated vapor concentration would be orders of magnitude below toxic concentration. It is only with modification and input (in terms of heat, cooling and size screening) that MDI substances become toxic after inhalation. In the EU risk assessment report (EU 2005) MDI is classified as  harmful by inhalation.   The acute inhalation data of pMDI and 4,4’-MDI data were considered by EU experts, and their conclusion that MDI be classified as “Harmful” and  reported in the 25th Adaptation to Technical Progress (ATP) to the Dangerous Substances Directive (67/548/EEC). This was endorsed in the 28th ATP and both MDI substances remain as “Harmful” in the 30th ATP (adopted by Member States on 16 February 2007 and published 15th September 2008). The original decision was upheld in the EU Risk Assessment of MDI (Directive 793/93/EEC, 3rd Priority List) published in 2005, noting that considering “the exposure assessment, it is reasonable to consider MDI as harmful only and to apply the risk management phrase ‘harmful by inhalation’. This classification was also endorsed by the Scientific Committee on Toxicity, Ecotoxicity and the Environment (CSTEE, now SCHER) in giving their opinion on the Risk Assessment (EC, 2008). With the enforcement of the CLP regulation (Regulation (EC) No 1272/2008) in 2009, the Dangerous Substance/Preparation Directive (DSD) was repealed and harmonized classifications were formally transferred to the CLP regulation; MDI is classified with Acute Tox. 4 H332 (Annex VI Regulation (EC) No 1272/2008 (CLP regu lation). Given the mechanism of action of the MDI substances and the changes in physical chemical properties imparted by the modifications in the modified MDI substances, the entire category is consistent with this guidance and classification, and the classification should not be changed.   The classification as “Harmful”, is equivalent to GHS Category 4. For these reasons, the GHS proposal follows the EU Regulatory lead accepting that the animal data are inappropriate and classified pMDI as GHS acute toxicity category 4 (ISOPA 2007).    Conclusion    Assessment of the available acute toxicity data indicates that inhalation exposure to the aerosols of MDI results in toxicity confined predominantly to the respiratory tract. In terms of hazard characterization, MDI is harmful by inhalation according to EU (H332) and GHS (Cat. 4) classification. MDI is non-toxic after single oral and dermal exposure.     Justification for classification or non classification:    EU classification according to CLP: H332     GHS classification (GHS UN rev.2, 2007): Inhalation route (vapour): Acute Category 4.     Not toxic by the dermal or oral routes. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Results are consistent within the key study Bomhard (1990) (reliability1)and data from a supporting study (Wazeter et al. 1964) (reliability 2). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b09ebd51-7f02-4f82-8dbb-f26edf22a42f/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_98b78b77-0045-4727-ac7c-c68d539d05a8.html,,,,,, o-(p-isocyanatobenzyl)phenyl isocyanate,5873-54-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b09ebd51-7f02-4f82-8dbb-f26edf22a42f/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_98b78b77-0045-4727-ac7c-c68d539d05a8.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, o-(p-isocyanatobenzyl)phenyl isocyanate,5873-54-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b09ebd51-7f02-4f82-8dbb-f26edf22a42f/documents/4a7c7495-33c0-4d72-839b-13bcf542bf4c_98b78b77-0045-4727-ac7c-c68d539d05a8.html,,inhalation,LC50,431 mg/m3,adverse effect observed, "O,O,O-triphenyl phosphorothioate",597-82-0,Oral: NOAEL = 39.5 mg/kg bw; rat; according to OECD TG 408; GLP; K1Inhalation: no study availableDermal: no study available ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8eca1e05-1782-4dc5-87b2-20f31369f815/documents/IUC5-c73e838b-a099-470b-89ce-3037957a53e1_72212304-1db0-4f03-8f44-94ddbf1444cf.html,,,,,, "O,O,O-triphenyl phosphorothioate",597-82-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8eca1e05-1782-4dc5-87b2-20f31369f815/documents/IUC5-c73e838b-a099-470b-89ce-3037957a53e1_72212304-1db0-4f03-8f44-94ddbf1444cf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,39.5 mg/kg bw/day,,rat "O,O,O-triphenyl phosphorothioate",597-82-0,"Oral: LD50 > 10000 mg/kg bw; rat; similar to OECD TG 401; prior-GLP; K2Inhalation: no study availableDermal: Read-Across, LD50 > 2000 mg/kg bw; rat; 24 h, according to OECD TG 402; GLP; K1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8eca1e05-1782-4dc5-87b2-20f31369f815/documents/IUC5-46476534-5ff8-4b3d-ac00-e5931827df1b_72212304-1db0-4f03-8f44-94ddbf1444cf.html,,,,,, "O,O,O-triphenyl phosphorothioate",597-82-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8eca1e05-1782-4dc5-87b2-20f31369f815/documents/IUC5-46476534-5ff8-4b3d-ac00-e5931827df1b_72212304-1db0-4f03-8f44-94ddbf1444cf.html,,oral,LD50,"> 10,000 mg/kg bw",no adverse effect observed, "O,O,O-triphenyl phosphorothioate",597-82-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8eca1e05-1782-4dc5-87b2-20f31369f815/documents/IUC5-46476534-5ff8-4b3d-ac00-e5931827df1b_72212304-1db0-4f03-8f44-94ddbf1444cf.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl) phosphorothioate",126019-82-7,NOAEL (OECD 407): 1000 mg/kg bw/d. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0a3d91a-2544-455d-a0d3-c9f9e3c49790/documents/9ce3f70f-eb84-4499-bd42-e6628087a3b8_0f4f9b8d-b6fd-411c-9603-880a07992387.html,,,,,, "O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl) phosphorothioate",126019-82-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0a3d91a-2544-455d-a0d3-c9f9e3c49790/documents/9ce3f70f-eb84-4499-bd42-e6628087a3b8_0f4f9b8d-b6fd-411c-9603-880a07992387.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl) phosphorothioate",126019-82-7,"LD50(oral, rat) > 2000 mg/kg bw/d. LD50(dermal, rat) > 2000 mg/kg bw/d. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0a3d91a-2544-455d-a0d3-c9f9e3c49790/documents/fff649ac-ab1c-4908-bacc-805bae566840_0f4f9b8d-b6fd-411c-9603-880a07992387.html,,,,,, "O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl) phosphorothioate",126019-82-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0a3d91a-2544-455d-a0d3-c9f9e3c49790/documents/fff649ac-ab1c-4908-bacc-805bae566840_0f4f9b8d-b6fd-411c-9603-880a07992387.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "O,O,O-tris(2(or 4)-C9-10-isoalkylphenyl) phosphorothioate",126019-82-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0a3d91a-2544-455d-a0d3-c9f9e3c49790/documents/fff649ac-ab1c-4908-bacc-805bae566840_0f4f9b8d-b6fd-411c-9603-880a07992387.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "O,O-bis(methylphenyl) hydrogen dithiophosphate",27157-94-4,"Repeated dose toxicity test was done according to OECD Guideline 422 under GLP compliance. Crj strain rats were used. No test item-related influence was noted on the reproduction parameters in any treatment group. The qualitative sperm staging revealed no test item-related spermatogenic changes. NOAEL (no-observed-adverse-effect level): above 137.1/182.8 mg/kg b.w./day, p.o. Effects on the development of the F1 offspring (pups) NOAEL (no-observed-adverse-effect level): 45.7 mg/kg b.w./day, p.o. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Good quality ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8210e990-6cce-46b7-82e0-fba42eeed93d/documents/522edbf8-111a-4ba6-987a-1832a5bb3275_3a503959-6f21-4978-af53-bea64d4aa798.html,,,,,, "O,O-bis(methylphenyl) hydrogen dithiophosphate",27157-94-4,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8210e990-6cce-46b7-82e0-fba42eeed93d/documents/522edbf8-111a-4ba6-987a-1832a5bb3275_3a503959-6f21-4978-af53-bea64d4aa798.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,45.7 mg/kg bw/day,,rat "O,O-diethyl hydrogen phosphorodithioate",298-06-6,"An acute oral toxicity study was performed in mice on EP1. EP1 was prepared as a 20% v/v emulsion in Tween-80 (10% aqueous solution) and administered at a maximum dosage volume of 20 mL/kg. Mice treated at Tween-80 (10%) in water (20 mL/kg) served as control. During the 14 -days observation period, record was kept of all mortalities and signs of toxicity. All mice were examined macroscopically to identify target organs. Autopsy revealed darkening of the liver and animals treated at 4 mL/kg (corresponding to 0.8 g/kg bw) showed ulceration of the stomach wall and intestine togeher with bleaching of parts of the liver. The acute median lethal oral dose (LD50) of EP1 was calculated to be 1.2 mL/kg bw, corresponding to 0.24 g/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31cb908c-f352-4160-800f-2516666163cf/documents/IUC5-d641f698-3ab7-46bd-a3a4-2c4e17c3ef3e_074673c1-7fa1-44a2-b04c-5db326440dbf.html,,,,,, "O,O-diethyl phosphorochloridothioate",2524-04-1,"In the IUCLID4 dataset on O,O-diethyl chlorothiophosphate, the results of several acute oral toxicity tests performed in rats are presented. The LD50 values are in the range of 953 - 1340 mg/kg bw/day.Further information on the acute toxicity of O,O-diethyl chlorothiophosphate is provided in the IUCLID4 dataset of 2000. Acute inhalation toxicity studies revealed LC 50 values in the range of 0.154 – 0.615 mg/L after 4 hour exposure and of >2.137 mg/L after one hour exposure in rats. Acute dermal toxicity studies in rats resulted in LD50 values of 719 – 1439 mg/kg bw. Administration via intaperitoneal injection resulted in an LD50 of 170 mg/kg bw in mice. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd1a4ceb-7277-4429-b511-793121c17ab7/documents/IUC5-e0c01f05-7812-4498-8766-ab6110c0dbab_076f9a61-c276-432b-8800-393645506538.html,,,,,, "O,O-diethyl phosphorochloridothioate",2524-04-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd1a4ceb-7277-4429-b511-793121c17ab7/documents/IUC5-e0c01f05-7812-4498-8766-ab6110c0dbab_076f9a61-c276-432b-8800-393645506538.html,,oral,LD50,953 mg/kg bw,, "O,O-diethyl phosphorochloridothioate",2524-04-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd1a4ceb-7277-4429-b511-793121c17ab7/documents/IUC5-e0c01f05-7812-4498-8766-ab6110c0dbab_076f9a61-c276-432b-8800-393645506538.html,,dermal,LD50,719 mg/kg bw,, "O,O-diethyl phosphorochloridothioate",2524-04-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd1a4ceb-7277-4429-b511-793121c17ab7/documents/IUC5-e0c01f05-7812-4498-8766-ab6110c0dbab_076f9a61-c276-432b-8800-393645506538.html,,inhalation,LC50,615 mg/m3,, "O,O-dimethyl hydrogen dithiophosphate",756-80-9,"The acute oral toxicity to rats (LD50) was found to be between 694 and 1200 mg/kg bw.An acute oral toxicity study was performed in mice on MP-1. LD50 was found to be 996 mg/kg bw.LD50 inhalation for rat (combiened sex) was 1.96 mg/l at 4h.Autopsy revealed darkening of the liver and animals treated at 4 mL/kg (corresponding to 0.8 g/kg bw) showed ulceration of the stomach wall and intestine togeher with bleaching of parts of the liver. The acute median lethal oral dose (LD50) of EP-1 was calculated to be 1.2 mL/kg bw, corresponding to 0.24 g/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96863506-7387-4901-b9bc-c12dcd49790e/documents/a65acab6-dec8-46ee-b353-8393ba5e45c3_8e6bef9a-e95e-46b9-ab5e-69c464aa11e4.html,,,,,, "O,O-dimethyl hydrogen dithiophosphate",756-80-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96863506-7387-4901-b9bc-c12dcd49790e/documents/a65acab6-dec8-46ee-b353-8393ba5e45c3_8e6bef9a-e95e-46b9-ab5e-69c464aa11e4.html,,oral,LD50,996 mg/kg bw,adverse effect observed, "O,O-dimethyl phosphorochloridothioate",2524-03-0,"Acute oral toxicity, oral to mice. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae9af95b-29e9-4942-8954-ceb7baadb83b/documents/IUC5-517083e4-c289-4bf0-a590-53d9abc2693e_3dec3f69-ec7b-4adf-856c-7e88939e80f8.html,,,,,, "O,O-dimethyl phosphorochloridothioate",2524-03-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae9af95b-29e9-4942-8954-ceb7baadb83b/documents/IUC5-517083e4-c289-4bf0-a590-53d9abc2693e_3dec3f69-ec7b-4adf-856c-7e88939e80f8.html,,oral,LD50,1.01 mg/kg bw,, "O,O-dimethyl phosphorochloridothioate",2524-03-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae9af95b-29e9-4942-8954-ceb7baadb83b/documents/IUC5-517083e4-c289-4bf0-a590-53d9abc2693e_3dec3f69-ec7b-4adf-856c-7e88939e80f8.html,,dermal,LD50,590 mg/kg bw,, "O,O-dimethyl phosphorochloridothioate",2524-03-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae9af95b-29e9-4942-8954-ceb7baadb83b/documents/IUC5-517083e4-c289-4bf0-a590-53d9abc2693e_3dec3f69-ec7b-4adf-856c-7e88939e80f8.html,,inhalation,LC50,0.34 mg/m3,, "O,O'-dioctadecylpentaerythritol bis(phosphite)",3806-34-6,Oral; NOEC > 3000 ppm; 90 days rat male/female; equivalent to OECD 408; Reyna (1972) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c11d39f9-f92f-4dc0-8058-00a41a10758b/documents/IUC5-7236afd7-9087-44ad-bcce-f6378d8716e7_7bcd5654-52ec-48f0-bbb1-38656ffa1aa6.html,,,,,, "O,O'-dioctadecylpentaerythritol bis(phosphite)",3806-34-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c11d39f9-f92f-4dc0-8058-00a41a10758b/documents/IUC5-7236afd7-9087-44ad-bcce-f6378d8716e7_7bcd5654-52ec-48f0-bbb1-38656ffa1aa6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "O,O'-dioctadecylpentaerythritol bis(phosphite)",3806-34-6,"Oral; LD50 > 10,000 mg/kg bw; male/female rat; equivalent to OECD 401; Widersich (1971)Inhalation; LC50 = > 2 mg/L; male/female rat; equivalent to OECD 403; Levi (1977)Dermal; LD50 = > 2000 mg/kg bw; male/female rat; OECD 402, US EPA OPP 81-2, US EPA OPPTS 798.1100; Kiplinger (1994) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c11d39f9-f92f-4dc0-8058-00a41a10758b/documents/IUC5-c199078e-0e97-4bf1-8d4e-3825de3a1ff2_7bcd5654-52ec-48f0-bbb1-38656ffa1aa6.html,,,,,, "O,O'-dioctadecylpentaerythritol bis(phosphite)",3806-34-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c11d39f9-f92f-4dc0-8058-00a41a10758b/documents/IUC5-c199078e-0e97-4bf1-8d4e-3825de3a1ff2_7bcd5654-52ec-48f0-bbb1-38656ffa1aa6.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "O,O'-dioctadecylpentaerythritol bis(phosphite)",3806-34-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c11d39f9-f92f-4dc0-8058-00a41a10758b/documents/IUC5-c199078e-0e97-4bf1-8d4e-3825de3a1ff2_7bcd5654-52ec-48f0-bbb1-38656ffa1aa6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "O,O-di-sec-butyl hydrogen dithiophosphate",107-55-1," By readacross from similar substances the LD50, rat (oral) is predicted to >1000 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e1e5528-3779-4af0-9220-1963b2c4a8ea/documents/0087e51b-1234-4c0d-b7de-91bb860060a0_2d9fd3e4-07ff-4d86-a2fe-81aa3088b202.html,,,,,, "O,O-di-sec-butyl hydrogen dithiophosphate",107-55-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e1e5528-3779-4af0-9220-1963b2c4a8ea/documents/0087e51b-1234-4c0d-b7de-91bb860060a0_2d9fd3e4-07ff-4d86-a2fe-81aa3088b202.html,,oral,LD50,"1,000 mg/kg bw",, "O,O-tert-butyl isopropyl monoperoxycarbonate",2372-21-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Adequate; study performed under GLP conditions ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d8e1c36-4a89-4770-89b1-f0b797619851/documents/e577eb9f-6487-4ba7-9c20-e4262c9b4644_9573c54d-ee21-4896-b3bb-a7ce57ca8f38.html,,,,,, "O,O-tert-butyl isopropyl monoperoxycarbonate",2372-21-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d8e1c36-4a89-4770-89b1-f0b797619851/documents/e577eb9f-6487-4ba7-9c20-e4262c9b4644_9573c54d-ee21-4896-b3bb-a7ce57ca8f38.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat "O,O-tert-butyl isopropyl monoperoxycarbonate",2372-21-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Good; GLP study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Good; GLP study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d8e1c36-4a89-4770-89b1-f0b797619851/documents/c463d7cd-d306-41c6-b727-15147ed3ae34_9573c54d-ee21-4896-b3bb-a7ce57ca8f38.html,,,,,, "O,O-tert-butyl isopropyl monoperoxycarbonate",2372-21-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d8e1c36-4a89-4770-89b1-f0b797619851/documents/c463d7cd-d306-41c6-b727-15147ed3ae34_9573c54d-ee21-4896-b3bb-a7ce57ca8f38.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "O,O-tert-butyl isopropyl monoperoxycarbonate",2372-21-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d8e1c36-4a89-4770-89b1-f0b797619851/documents/c463d7cd-d306-41c6-b727-15147ed3ae34_9573c54d-ee21-4896-b3bb-a7ce57ca8f38.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, O-acetylsalicylic acid,50-78-2,"No valid repeated dose toxicity studies on acetylsalicylic acid are available. A read-across approach is therefore proposed from studies on Methyl salicylate (MeS) which is readily metabolised to salicylic acid (See section.7.1.1), the main metabolite of ASA. On the other hand there is a long history of human use of ASA.A set of studies was conducted on MeS by Webb & Hansen (1963), consisting of oral feeding studies of duration 17 weeks and 2 years in rats, studies in dogs by capsule administration of duration 59 days and 2 years, and a dermal study in rabbits. These studies did not examine all the parameters recommended in the current OECD guidelines 409 and 452, however they were conducted according to good scientific principles by US FDA. The chronic studies in rat and dog are therefore proposed as key studies for this endpoint, with the subchronic studies in rats and dogs as supporting study. A second set of subacute oral studies was conducted on MeS by Abbott & Harrisson (1978) to further investigate the effects on bone in rats and liver in dogs, identified in the studies by Webb & Hansen. These are considered to be acceptable as supporting studies. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21b15b7e-f4f1-40b9-b706-075fa2378840/documents/IUC5-ec047626-83ec-4479-87e1-d35bede4e283_28d04461-9b17-408b-972f-9baf5835a744.html,,,,,, O-acetylsalicylic acid,50-78-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21b15b7e-f4f1-40b9-b706-075fa2378840/documents/IUC5-ec047626-83ec-4479-87e1-d35bede4e283_28d04461-9b17-408b-972f-9baf5835a744.html,Sub-chronic toxicity – systemic effects,dermal,LOAEL,590 mg/kg bw/day,,rabbit O-acetylsalicylic acid,50-78-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21b15b7e-f4f1-40b9-b706-075fa2378840/documents/IUC5-ec047626-83ec-4479-87e1-d35bede4e283_28d04461-9b17-408b-972f-9baf5835a744.html,Chronic toxicity – systemic effects,oral,NOAEL,59 mg/kg bw/day,,rat O-acetylsalicylic acid,50-78-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21b15b7e-f4f1-40b9-b706-075fa2378840/documents/IUC5-ec047626-83ec-4479-87e1-d35bede4e283_28d04461-9b17-408b-972f-9baf5835a744.html,Repeated dose toxicity – local effects,dermal,NOAEL,"1,180 ",adverse effect observed,rabbit O-acetylsalicylic acid,50-78-2,Rabbit LD50 > 7940 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21b15b7e-f4f1-40b9-b706-075fa2378840/documents/IUC5-f72a4312-da9f-4f98-a4b5-cdf27a327fba_28d04461-9b17-408b-972f-9baf5835a744.html,,,,,, O-acetylsalicylic acid,50-78-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21b15b7e-f4f1-40b9-b706-075fa2378840/documents/IUC5-f72a4312-da9f-4f98-a4b5-cdf27a327fba_28d04461-9b17-408b-972f-9baf5835a744.html,,oral,LD50,"1,725 mg/kg bw",adverse effect observed, o-Biphenyl-dimethylfluorenyl-amin,1198395-24-2, OECD 423: LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec68c77b-39d1-4544-b9d9-97cb962ba946/documents/b3de84ad-2e66-490d-b367-83b80f9cdb0c_8aa0a549-c859-4e76-bbad-1fce8fe8c38b.html,,,,,, o-Biphenyl-dimethylfluorenyl-amin,1198395-24-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec68c77b-39d1-4544-b9d9-97cb962ba946/documents/b3de84ad-2e66-490d-b367-83b80f9cdb0c_8aa0a549-c859-4e76-bbad-1fce8fe8c38b.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, o-chlorobenzenethiol,6320-03-2," Acute oral toxicity: Data waiving (study scientifically not necessary / other information available). In accordance with column 2 of REACH Annex VII, the study need not be conducted because the substance is classified as corrosive to the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3d42941-7a31-4ba4-8424-c29f0dddf751/documents/99bb483c-f678-4510-bbd8-4bf5e72c86d0_d1b05886-4870-4f14-b96b-ad5d2dc6583d.html,,,,,, Oct-2-ene,111-67-1," Based on the results of a OECD 408 90-day study on the read-across source oct-1-ene in rats (Envigo 2015), the No Observed Effect Level (NOEL) was considered to be 100 mg/kg bw/day for females and was not established for males. The No Observed Adverse Effect Level (NOAEL) was established at 1000 mg/kg bw/day for females and males because the findings were either not considered to reflect true systemic toxicity or were not relevant for human health. In an Oral (Gavage) Combined Repeat Dose Toxicity Study with Reproduction/Developmental Toxicity Screening Test in the Rat (OECD 422) using oct-1-ene, the ‘No Observed Effect Level’ (NOEL) for systemic toxicity was considered to be 300 mg/kg bw/day, based on irritation in the forestomach at 1000 mg/kg/day. The NOAEL was however considered to be 1000 mg/kg bw/day because the findings were not evidence of true systemic toxicity. In a 28-day dermal toxicity study, the read-across source alpha olefin 8 was applied to the shaved skin of six New Zealand white rabbits (3 intact and 3 abraded) at a dose level of 0.2 millilitres for 5 days/week during a 28-day period. The skin was ranked using a graded system by the study authors ranging from 1 (none) to 6 (severe). The average score for hyperaemia, exfoliation, and scab formation was approximately 2 (considered questionable). There were no other toxicity results reported. Therefore, noLOAEL orNOAEL were identified. Read-across to Oct-2-ene is claimed as valid basd on the justifications provided for both analogue and category approaches. Therefore the systemic NOAEL for oct-2-ene is considered to be 1000 mg/kg bw/day because the findings of both source studies did not produce evidence of true systemic toxicity. Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24.The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   Read-across of these results to Oct-2 -ene is claimed as valid based on the justifications provided for both analogue and category approaches ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d3495a8-8cd2-4436-a392-8b638623bd5c/documents/8181c882-2676-41d0-85dc-d0c3f848c6b2_c8c50e90-b1b2-4db5-9387-a48449b58fe4.html,,,,,, Oct-2-ene,111-67-1,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d3495a8-8cd2-4436-a392-8b638623bd5c/documents/72c709e0-a807-4b4b-9740-8220b9a876b0_c8c50e90-b1b2-4db5-9387-a48449b58fe4.html,,,,,, Oct-7-en-1-ol,13175-44-5," Acute oral toxicity The test article, Oct-7-en-1-ol meets the criteria for classification for skin corrosivity from data generated in the EpiDerm in vitro irritation [1] and corrosivity [2] models. In accordance with the ECHA Chapter R.7a guidance [3], a waiver is requested as Oct-7-en-1-ol is classified as skin corrosion (Category 1) and therefore an acute oral toxicity study to address this endpoint is not required. Consequently, the required standard information in Column 2 are met. Based on the available skin irritation and skin corrosion data, it is scientifically robust to submit a waiver for the acute oral toxicity endpoint as stated in the R.7a guidance for REACh.   Based on the skin corrosion (Category 1) classification, classification for acute oral toxicity is not warranted.   References 1.Mochizuki, H. (2017).In vitro skin irritation study of OEA using EpiDerm. Ina Research Inc., Nagano, Japan. Unpublished report No.: DK16295 2. Suzuki, M. (2017).In vitro skin corrosion test of OEA using EpiDerm SCT (EPI-200). Chemicals Evaluation and Research Institute, Japan, Hita. Unpublished report No.: K10-0242 3. ECHA (European Chemicals Agency). Guidance on information requirements and chemical safety assessment. Chapter R.7a: Endpoint specific guidance. December 2016 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/391c97a0-cd8b-43bc-b7f0-8b9668fb6b21/documents/8af21f34-ee12-4193-8970-e4d8591e61db_2dd8abf1-bcc0-491b-91c3-d914010bfdfe.html,,,,,, Oct-7-enal,21573-31-9," Acute oral toxicity Oct-7-enal was administered undiluted orally via gavage, initially at 550 mg/kg bw to a single female using the up and down procedure. As the animal survived the dose for the next animal was increased to 2000 mg/kg bw. Each animal was observed carefully for up to 48 hours before making a decision on whether and how much to dose the next animal. That decision was based on the 48-hour survival pattern of all the animals up to that time. A combination of stopping criteria was used to keep the number of animals low. For all rats body weights were measured and a gross necropsy was performed at the end of the observation period. The most relevant clinical findings in the animal treated with the test item at a dose of 550 mg/kg bw were reduced spontaneous activity, piloerection, half eyelid closure and alopecia. The most relevant clinical findings in the animal treated with the test item at a dose of 2000 mg/kg bw were reduced spontaneous activity, hunched posture, piloerection and half eyelid closure. There were no treatment related effect on body weight and no abnormalities were recorded at necropsy in rats in either group. The rat acute oral LD50 was > 2000 mg/kg bw in female rats. Therefore, according to Annex I for Regulation (EC) 1272/2008 the active ingredient, oct-7-enal has no obligatory labelling requirement for acute oral toxicity and is unclassified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad33e9de-e72c-4e0f-9d35-874234662d42/documents/04ee4687-6af1-4b48-b95c-fdc83482b9f1_cb6b7b80-2d8a-4720-9a5c-7e74e40940cb.html,,,,,, Oct-7-enal,21573-31-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad33e9de-e72c-4e0f-9d35-874234662d42/documents/04ee4687-6af1-4b48-b95c-fdc83482b9f1_cb6b7b80-2d8a-4720-9a5c-7e74e40940cb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Octa-1,7-diene",3710-30-3," Oral treatment with 1,7-Octadiene to rats for 90 consecutive days did not cause any effects of biological or toxicological significance at the low or intermediate doses of 100 or 300 mg/kg b.w./day. The high dose of 1000 mg/kg b.w./day for 90 days caused an increased drinking water consumption of male animals, and increased plasma levels of total cholesterol and triglycerides in male and female animals. The kidney and liver weights were increased in male and female animals. Additionally, the high dose group revealed histopathological changes in the kidney (chronic progressive nephropathy, tubule hypertrophy) and the stomach (non-glandular: hyperkeratosis, squamous cell hyperplasia), being slightly more severe in the male animals compared to the female animals. The histopathological changes observed in kidney and stomach are either generally reversible (hyperplasia and hyperkeratosis) after discontinuation of dosing or are a male rat-specific spontaneous age-related disease that may be exacerbated by chemicals, but a rodent disease of no relevance for extrapolation in human risk assessment. No test item-related effects were noted in the testes and the epididymides of the male animals at any dose level. In conclusion, the experimental no-observed-adverse-effect level (NOAEL) was at 300 mg 1,7 -Octadiene/kg b.w./day by oral administration ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd52e4be-1767-4d72-8f3c-7d541f2447fd/documents/IUC5-c4e775f6-4f2c-466a-b4ed-269d946b170c_d1d03e64-d26a-48fb-a3b6-c9692af087d6.html,,,,,, "Octa-1,7-diene",3710-30-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd52e4be-1767-4d72-8f3c-7d541f2447fd/documents/IUC5-c4e775f6-4f2c-466a-b4ed-269d946b170c_d1d03e64-d26a-48fb-a3b6-c9692af087d6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Octa-1,7-diene",3710-30-3,"Oral (OECD 423), rat: LD50 > 2000 mg/kg bw; LD50 cut-off value = 5000 mg/kg bw (limit test)Inhalation, rat: LC50 > 36 mg/L air ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd52e4be-1767-4d72-8f3c-7d541f2447fd/documents/IUC5-26e974c6-1a35-4c7b-8451-e2342d0c42d9_d1d03e64-d26a-48fb-a3b6-c9692af087d6.html,,,,,, Octachlorotrisilane,13596-23-1," In accordance with Column 2 of REACH Annex VII, the acute oral toxicity study (required in Section 8.5.1) does not need to be conducted as the substance is classified as corrosive to skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41b23ca3-8ae3-480d-8138-81740c28c2df/documents/34ce1e9b-3f01-40f9-9f03-5ea3ebaf39a1_09040b61-8f34-4cd2-94ea-f11e7bf184b1.html,,,,,, Octadec-1-ene,112-88-9," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b4184a9-c0ba-44fc-9de1-893806e4711a/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_4a7f05fa-d0c5-4534-84f4-5f34de374844.html,,,,,, Octadec-1-ene,112-88-9,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b4184a9-c0ba-44fc-9de1-893806e4711a/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_4a7f05fa-d0c5-4534-84f4-5f34de374844.html,,,,,, Octadec-2-enylsuccinic acid,68015-93-0, Three acute oral toxicity studies are available for the Substance. The acute oral toxicity study conclusions are summarised as follows: Acute Oral 2016 - LD50 > 2000 mg/kg Acute Oral 2000 - LD50 > 2000 mg/kg Acute Oral 1976 - LD50 > 5000 mg/kg Based on the weight of evidence the data indicates that the estimated LD50 for the substance is > 5000 mg/kg One acute dermal toxicity studies are available for the Substance. The acute dermal toxicity study concluded that the Acute dermal LD50 was > 3160 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d2d51a0-2a21-472e-98ad-11bc4aba77a4/documents/1c7efd94-02f0-47e9-91b2-4d94759c4a76_0fe6ba4b-d45b-424a-9932-426b332bbdd3.html,,,,,, Octadec-2-enylsuccinic acid,68015-93-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d2d51a0-2a21-472e-98ad-11bc4aba77a4/documents/1c7efd94-02f0-47e9-91b2-4d94759c4a76_0fe6ba4b-d45b-424a-9932-426b332bbdd3.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Octadec-2-enylsuccinic acid,68015-93-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d2d51a0-2a21-472e-98ad-11bc4aba77a4/documents/1c7efd94-02f0-47e9-91b2-4d94759c4a76_0fe6ba4b-d45b-424a-9932-426b332bbdd3.html,,dermal,LD50,"3,160 mg/kg bw",no adverse effect observed, Octadecane-1-thiol,2885-00-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ba1bac8-b9bb-4c96-9c6e-b92a9d4147cc/documents/e148ad3d-8936-412a-9946-977a24ff2414_7e1d5112-f28e-4a70-b805-d649226a95e8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Octadecane-1-thiol,2885-00-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ba1bac8-b9bb-4c96-9c6e-b92a9d4147cc/documents/64c3682e-44e6-42ab-a1fd-8d3952930272_7e1d5112-f28e-4a70-b805-d649226a95e8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,18-dimethyl octadecanedioate",1472-93-1," Short-term repeated dose oral toxicity (OECD 422) (read-across from supporting substance, structural analogue EC 662-772-0): The oral administration of 9-decenoic acid, methyl ester (9DAME) to rats by gavage, at dose levels of 30, 300 and 1000 mg/kg bw/day did not result in any toxicological significant effects. The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic  toxicity was therefore considered to be 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b2ca1b3-b66c-42e3-8bc3-c4c5f488d748/documents/b557a4fa-e72b-460b-8f70-8e22e674749e_da4c7d0b-8915-4373-a425-8b8d6ee21b6e.html,,,,,, "1,18-dimethyl octadecanedioate",1472-93-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b2ca1b3-b66c-42e3-8bc3-c4c5f488d748/documents/b557a4fa-e72b-460b-8f70-8e22e674749e_da4c7d0b-8915-4373-a425-8b8d6ee21b6e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,18-dimethyl octadecanedioate",1472-93-1," Acute Oral Toxicity: The acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight. Acute Dermal Toxicity (read-across from supporting substance, structural analogue EC 662-772-0): The acute dermal LD50 of the test item in the Wistar strain rat was found to be >2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b2ca1b3-b66c-42e3-8bc3-c4c5f488d748/documents/IUC5-ef6eeb26-37de-43e3-9aa3-e879e1459298_da4c7d0b-8915-4373-a425-8b8d6ee21b6e.html,,,,,, "1,18-dimethyl octadecanedioate",1472-93-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b2ca1b3-b66c-42e3-8bc3-c4c5f488d748/documents/IUC5-ef6eeb26-37de-43e3-9aa3-e879e1459298_da4c7d0b-8915-4373-a425-8b8d6ee21b6e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,18-dimethyl octadecanedioate",1472-93-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b2ca1b3-b66c-42e3-8bc3-c4c5f488d748/documents/IUC5-ef6eeb26-37de-43e3-9aa3-e879e1459298_da4c7d0b-8915-4373-a425-8b8d6ee21b6e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Octadecanoic acid, 1-(2-hydroxy-2-methylpropoxy)-2,2,6,6-tetramethyl-4-piperidinyl ester",290822-07-0," The test substance was administered to rats in a daily diet over a period of 28 days (according GLP and OECD guideline 407). Since no treatment related effects occurred during the study and during recovery period, the dosage level of 1000 mg/kg/day is considered to be the no-observed-effect level (NOEL) and the no-observed-adverse effect level (NOAEL) of the test substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df67d600-1208-4a09-b543-422fa153f709/documents/IUC5-9fc85485-0577-4be3-8465-84feebdff192_5eb9282e-c606-4772-a8c7-ba2c46271cc6.html,,,,,, "Octadecanoic acid, 1-(2-hydroxy-2-methylpropoxy)-2,2,6,6-tetramethyl-4-piperidinyl ester",290822-07-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/df67d600-1208-4a09-b543-422fa153f709/documents/IUC5-9fc85485-0577-4be3-8465-84feebdff192_5eb9282e-c606-4772-a8c7-ba2c46271cc6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Octadecanoic acid, 1-(2-hydroxy-2-methylpropoxy)-2,2,6,6-tetramethyl-4-piperidinyl ester",290822-07-0, The acute oral and dermal toxicity of the test substance was evaluated in three different studies in rats. One male animal died by day 9 of the dermal toxicity study. The death is not considered as treatment-releated mortality. Gross pathology was without any findings. Diarrhoea was observed in one oral toxicity study and is considered as high dose phenomenom. LD50 in acute oral and dermal test was estimated to be greater than 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df67d600-1208-4a09-b543-422fa153f709/documents/IUC5-2d6471e0-d72a-4fb3-a81e-2add35cfdc18_5eb9282e-c606-4772-a8c7-ba2c46271cc6.html,,,,,, "Octadecanoic acid, 1-(2-hydroxy-2-methylpropoxy)-2,2,6,6-tetramethyl-4-piperidinyl ester",290822-07-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df67d600-1208-4a09-b543-422fa153f709/documents/IUC5-2d6471e0-d72a-4fb3-a81e-2add35cfdc18_5eb9282e-c606-4772-a8c7-ba2c46271cc6.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Octadecanoic acid, 1-(2-hydroxy-2-methylpropoxy)-2,2,6,6-tetramethyl-4-piperidinyl ester",290822-07-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df67d600-1208-4a09-b543-422fa153f709/documents/IUC5-2d6471e0-d72a-4fb3-a81e-2add35cfdc18_5eb9282e-c606-4772-a8c7-ba2c46271cc6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Octadecanoic acid, branched and linear",68201-37-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ef865dc-2964-4e9e-9786-590e4a778498/documents/IUC5-aadcbf68-ae79-4ab1-9870-bf0b705e210b_e41382eb-8be2-4df5-96ee-31be925e6e32.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Octadecanoic acid, C16-20-branched alkyl esters",85203-92-5, Oral (OECD 401): LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30dc14f9-f903-4577-b618-539a48b9c7ab/documents/1908fe93-9c19-4bbb-9108-490bcf2121c8_532b2983-7e97-4bec-8c23-ac3fa7361cdb.html,,,,,, "Octadecanoic acid, C16-20-branched alkyl esters",85203-92-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30dc14f9-f903-4577-b618-539a48b9c7ab/documents/1908fe93-9c19-4bbb-9108-490bcf2121c8_532b2983-7e97-4bec-8c23-ac3fa7361cdb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Octadecanoic acid, reaction products with 2-amino-2-methyl-1-propanol",68951-62-2," Based on the results of the read across study, the NOAEL for systemic toxicity of the test substance, C16 -18 AMP, can be considered to be at 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c3dcbcf-ded7-4ba5-9f54-7ae88056a39e/documents/c8a23ce1-584e-4137-a60f-fe5a7ccb4aaa_072a983b-09f6-4f66-82a8-87072bd52e9c.html,,,,,, "Octadecanoic acid, reaction products with 2-amino-2-methyl-1-propanol",68951-62-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c3dcbcf-ded7-4ba5-9f54-7ae88056a39e/documents/c8a23ce1-584e-4137-a60f-fe5a7ccb4aaa_072a983b-09f6-4f66-82a8-87072bd52e9c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Octadecanoic acid, reaction products with 2-amino-2-methyl-1-propanol",68951-62-2," Based on the results of a read across study, the oral LD50 value of the test substance, C16 -18 AMP is considered to be >2000 mg/kg bw (indicating low acute oral toxicity potential). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c3dcbcf-ded7-4ba5-9f54-7ae88056a39e/documents/ea62e8bf-e286-45a6-9b37-2d602f6dbfdf_072a983b-09f6-4f66-82a8-87072bd52e9c.html,,,,,, "Octadecanoic acid, reaction products with 2-amino-2-methyl-1-propanol",68951-62-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c3dcbcf-ded7-4ba5-9f54-7ae88056a39e/documents/ea62e8bf-e286-45a6-9b37-2d602f6dbfdf_072a983b-09f6-4f66-82a8-87072bd52e9c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine",68585-02-4," The oral LD50 of > 2000 mg/kg bw was determined for Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine in an OECD 423 guideline studie. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65196fac-a2b1-4d3c-8c99-f9b47085eb0a/documents/30f3bc74-6b1e-4861-bf47-6539bf43c9b8_3804c080-676b-4541-b0c2-4f0769fa9fc7.html,,,,,, "Octadecanoic acid, reaction products with acetic acid and tetraethylenepentamine",68585-02-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65196fac-a2b1-4d3c-8c99-f9b47085eb0a/documents/30f3bc74-6b1e-4861-bf47-6539bf43c9b8_3804c080-676b-4541-b0c2-4f0769fa9fc7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Octadecanoic acid, reaction products with diethylenetriamine and urea, acetates",84962-05-0,"A study was conducted according to OECD guideline 422 and in accordance with GLP. The purpose of this study was to generate preliminary information concerning the effects of FAT 93580/A on the possible health hazards likely to arise from repeated exposure over a relatively limited period of time. In addition, it provides information on possible effects on male and female reproductive performance such as gonadal function, mating behaviour, conception, development of the conceptus and parturition. FAT 93580/A was administered to male rats for 6 weeks and to female rats for 15 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post-partum. NOAEL for males and females was established at 1000 mg/kg/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Key study with reliability rating 1 performed according to OECD guideline 422 and in accordance with GLP. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c4d2cf5-81f5-4c88-a937-a706ea8d8b9b/documents/IUC5-f453649d-5394-425d-9e1e-6359de92c780_a840ec1f-3cbf-4bc5-aa54-2b593781588d.html,,,,,, "Octadecanoic acid, reaction products with diethylenetriamine and urea, acetates",84962-05-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c4d2cf5-81f5-4c88-a937-a706ea8d8b9b/documents/IUC5-f453649d-5394-425d-9e1e-6359de92c780_a840ec1f-3cbf-4bc5-aa54-2b593781588d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Octadecanoic acid, reaction products with diethylenetriamine and urea, acetates",84962-05-0,"Key study was performed according to OECD TG 420 following GLP reports in rats. The results showed a LD50 of >2000 mg/kg/d. Whereas, Support study performed in the year 1975 with no test guideline and GLP records in rats showed a LD50 of >5000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c4d2cf5-81f5-4c88-a937-a706ea8d8b9b/documents/IUC5-c5a5066f-f9e0-40a3-9d9d-fbaa232269f3_a840ec1f-3cbf-4bc5-aa54-2b593781588d.html,,,,,, "Octadecanoic acid, reaction products with diethylenetriamine and urea, acetates",84962-05-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c4d2cf5-81f5-4c88-a937-a706ea8d8b9b/documents/IUC5-c5a5066f-f9e0-40a3-9d9d-fbaa232269f3_a840ec1f-3cbf-4bc5-aa54-2b593781588d.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Octadecyl 3-mercaptopropionate,31778-15-1,"Based on read-across from MMP, iOMP and iC13MP, ODMP is predicted to harmful if swallowed.. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53cfcad8-2856-453d-9cc8-39faa086d33f/documents/31878f6a-f817-4e88-9a41-b5e31d0178ef_bb1fb1a9-a35b-4358-b7f9-f7b51e89f58b.html,,,,,, Octadecyl 3-mercaptopropionate,31778-15-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53cfcad8-2856-453d-9cc8-39faa086d33f/documents/31878f6a-f817-4e88-9a41-b5e31d0178ef_bb1fb1a9-a35b-4358-b7f9-f7b51e89f58b.html,,oral,LD50,> 500 mg/kg bw,adverse effect observed, Octadecyl 3-mercaptopropionate,31778-15-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53cfcad8-2856-453d-9cc8-39faa086d33f/documents/31878f6a-f817-4e88-9a41-b5e31d0178ef_bb1fb1a9-a35b-4358-b7f9-f7b51e89f58b.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, 1-octadecylnaphthalene,56388-48-8, A well-conducted GLP OECD 422 study with an analogue of the substance indicated no adverse effects up to the maximum dose of 1000 mg/kg/day which was established as the NOAEL. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/437faf1a-0c3a-420a-937c-457224268120/documents/a835350a-5df3-4c1b-a883-06d8ebb33573_344f3157-79a9-4847-a64e-793e54ccc285.html,,,,,, 1-octadecylnaphthalene,56388-48-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/437faf1a-0c3a-420a-937c-457224268120/documents/a835350a-5df3-4c1b-a883-06d8ebb33573_344f3157-79a9-4847-a64e-793e54ccc285.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat 1-octadecylnaphthalene,56388-48-8, For the analogue the following data are available: Acute oral LD50 > 2000 mg/kg bw Acute dermal LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/437faf1a-0c3a-420a-937c-457224268120/documents/d5fe0b71-f2fe-4e72-bf83-7d2879847ff3_344f3157-79a9-4847-a64e-793e54ccc285.html,,,,,, 1-octadecylnaphthalene,56388-48-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/437faf1a-0c3a-420a-937c-457224268120/documents/d5fe0b71-f2fe-4e72-bf83-7d2879847ff3_344f3157-79a9-4847-a64e-793e54ccc285.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 1-octadecylnaphthalene,56388-48-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/437faf1a-0c3a-420a-937c-457224268120/documents/d5fe0b71-f2fe-4e72-bf83-7d2879847ff3_344f3157-79a9-4847-a64e-793e54ccc285.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Octahydro-1,3,5,7-tetranitro-1,3,5,7-tetrazocine",2691-41-0,NOAEL from a 90-day repeat dose study in rats was 51 mg/kg day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/091ccb0e-de39-4a81-a645-35a2dabeaf60/documents/IUC5-1c012c1b-8865-4adc-85eb-64c416d865d3_f6769427-0a61-4a8c-a4d4-736ba2abf136.html,,,,,, "Octahydro-1,3,5,7-tetranitro-1,3,5,7-tetrazocine",2691-41-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/091ccb0e-de39-4a81-a645-35a2dabeaf60/documents/IUC5-1c012c1b-8865-4adc-85eb-64c416d865d3_f6769427-0a61-4a8c-a4d4-736ba2abf136.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,51 mg/kg bw/day,,rat "Octahydro-1,3,5,7-tetranitro-1,3,5,7-tetrazocine",2691-41-0,The LD50 of acute oral toxicity in rats is 6250 mg/kg bw but LD50 in male mice = 1670 mg/kg and 3240 mg/kg for female mice. LD50 for dermal toxicity in rats is >4230 mg/kg bw but LD50 is  634.12 mg/kg for male rabbits and 718.56 mg/kg for female rabbits . No inhalation data is available as the study was waived as being scientifically unjustified due to the large particle sizes of the test substance (>77% is a non-respirable fraction according to the granulometry data). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/091ccb0e-de39-4a81-a645-35a2dabeaf60/documents/IUC5-875cf919-9e6b-44a3-80a0-fb037c2cdd7f_f6769427-0a61-4a8c-a4d4-736ba2abf136.html,,,,,, "Octahydro-1,3,5,7-tetranitro-1,3,5,7-tetrazocine",2691-41-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/091ccb0e-de39-4a81-a645-35a2dabeaf60/documents/IUC5-875cf919-9e6b-44a3-80a0-fb037c2cdd7f_f6769427-0a61-4a8c-a4d4-736ba2abf136.html,,oral,LD50,"1,670 mg/kg bw",adverse effect observed, "Octahydro-1,3,5,7-tetranitro-1,3,5,7-tetrazocine",2691-41-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/091ccb0e-de39-4a81-a645-35a2dabeaf60/documents/IUC5-875cf919-9e6b-44a3-80a0-fb037c2cdd7f_f6769427-0a61-4a8c-a4d4-736ba2abf136.html,,dermal,LD50,634 mg/kg bw,adverse effect observed, Octahydro-2H-1-benzopyran-2-one,4430-31-3,OECD TG 422: NOAEL 128 mg/kg bw corresponding to a nominal dietary exposure of 1000 ppm) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/005e6e4b-e85b-4ac5-b94e-2fd627780abe/documents/IUC5-daa8dfb2-7301-4053-8e46-4ff62be2f65e_07e339b7-f298-4b94-b9b2-77e128b7ce3b.html,,,,,, Octahydro-2H-1-benzopyran-2-one,4430-31-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/005e6e4b-e85b-4ac5-b94e-2fd627780abe/documents/IUC5-daa8dfb2-7301-4053-8e46-4ff62be2f65e_07e339b7-f298-4b94-b9b2-77e128b7ce3b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,128 mg/kg bw/day,,rat Octahydro-2H-1-benzopyran-2-one,4430-31-3, Acute oral (OECDTG401): no adverse effect observed Acute dermal (OECDTG402): no adverse effect observed Acute inhalation (Route to route extrapolation): no adverse effect predicted ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/005e6e4b-e85b-4ac5-b94e-2fd627780abe/documents/IUC5-8a403878-d6e7-407c-8205-1d093aabc944_07e339b7-f298-4b94-b9b2-77e128b7ce3b.html,,,,,, "Octahydro-4,7-methano-1H-indene-5-methanol",57526-50-8," The oral LD50 for male and female rats is 3350 and 2270 for male and female rats, respectively. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dc91140-827e-4e0f-821c-1e4a4a1db386/documents/1b350ecd-77b5-4a9b-b51b-0720046faf08_d3472398-d598-481f-a472-811ce218901c.html,,,,,, "Octahydro-4,7-methano-1H-indene-5-methanol",57526-50-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dc91140-827e-4e0f-821c-1e4a4a1db386/documents/1b350ecd-77b5-4a9b-b51b-0720046faf08_d3472398-d598-481f-a472-811ce218901c.html,,oral,LD50,"2,270 mg/kg bw",adverse effect observed, Octamethylenediamine,373-44-4,"Oral: The acute oral LD50 was investigated in 4 studies and was determined to be ca. 500 mg/kg bw in rats.Dermal and inhalation toxicity: In accordance with column 2 of REACH Annex VIII, the test on acute toxicity (required in section 8.5) does not need to be conducted as the available information show that the criteria are met for classification as corrosive to the skin (R34, skin corr. cat. 1B). In conclusion, no further testing is required in accordance with animal welfare reasons. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d83c8b3c-d114-4974-806a-ef664286efbe/documents/IUC5-ea55f3de-729b-48a3-a14d-3985ea57b492_928943ee-4b82-44b8-a677-80299bc6dd8c.html,,,,,, Octamethylenediamine,373-44-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d83c8b3c-d114-4974-806a-ef664286efbe/documents/IUC5-ea55f3de-729b-48a3-a14d-3985ea57b492_928943ee-4b82-44b8-a677-80299bc6dd8c.html,,oral,LD50,500 mg/kg bw,, "1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorooctane",80793-17-5,The results from an oral 28-day subacute repeated dose toxicity study showed that AC-6000 exerted effects on the liver. The NOAEL of AC-6000 in rats under the present study conditions was estimated to be 40 mg/kg bw/day due to increased relative liver weights and enlargement of the liver in males and females and centrilobular hypertrophy of the hepatocytes and increased relative kidney weights in males dosed with 200 mg/kg bw/day.   ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5eea5efa-e996-448c-8be7-012ff460471c/documents/IUC5-f734d12a-31da-46d4-b7fa-a849952eaf3a_93e47a0e-c010-40ae-af80-24b608741bea.html,,,,,, "1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorooctane",80793-17-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5eea5efa-e996-448c-8be7-012ff460471c/documents/IUC5-f734d12a-31da-46d4-b7fa-a849952eaf3a_93e47a0e-c010-40ae-af80-24b608741bea.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat "1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorooctane",80793-17-5,The acute oral LD50 of AC-6000 is >2500 mg/kg bw. The acute inhalation LC50 of AC-6000 is >139.7 mg/L (analytical concentration) / >153.7 mg/l (nominal concentration). The acute dermal LD50 of AC-6000 is >2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5eea5efa-e996-448c-8be7-012ff460471c/documents/IUC5-a469c150-5432-4b87-9484-ae654a9077b9_93e47a0e-c010-40ae-af80-24b608741bea.html,,,,,, "1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorooctane",80793-17-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5eea5efa-e996-448c-8be7-012ff460471c/documents/IUC5-a469c150-5432-4b87-9484-ae654a9077b9_93e47a0e-c010-40ae-af80-24b608741bea.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorooctane",80793-17-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5eea5efa-e996-448c-8be7-012ff460471c/documents/IUC5-a469c150-5432-4b87-9484-ae654a9077b9_93e47a0e-c010-40ae-af80-24b608741bea.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorooctane",80793-17-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5eea5efa-e996-448c-8be7-012ff460471c/documents/IUC5-a469c150-5432-4b87-9484-ae654a9077b9_93e47a0e-c010-40ae-af80-24b608741bea.html,,inhalation,LC50,"139,700 mg/m3",no adverse effect observed, Octane-1-thiol,111-88-6,"There is a 28-day repeat oral dosing study with octane-1-thiol. There are also repeat dose toxicity studies by the inhalation route with dodecane-1-thiol, which is a structural analogue of octane-1-thiol. Oral gavage treatment of rats with octane-1-thiol resulted in effects consistent with forestomach irritation and corrosion (thickening of forestomach wall, ulcers, inflammatory cell infiltration). The effects on the forestomach reflect effects from direct contact with octane-1-thiol and not to systemic effects. Other treatment-related effects appear to be secondary to the irritation/corrosive effects on the forestomach, with the possible exception of the centrilobular hepatocyte hypertrophy. The NOAEL for the 28-day study is 50 mg/kg bw/day.Exposure of rats, dogs and mice to structural analog dodecane-1-thiol resulted in skin irritation and secondary effects in the regional lymph nodes. There were treatment-related effects on the respiratory system. The effects of the skin reflect direct contact with dodecane-1-thiol and not to systemic effects. The NOAEC from these studies is 1.9 ppm (20 mg/m3). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97ab82cf-5310-4402-bcc3-2ccd4828d4b4/documents/IUC5-b49d8ace-75e8-409b-89c3-ec27026b8228_ddcbc907-8cda-4145-bb4f-1d0d3f419554.html,,,,,, Octane-1-thiol,111-88-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97ab82cf-5310-4402-bcc3-2ccd4828d4b4/documents/IUC5-b49d8ace-75e8-409b-89c3-ec27026b8228_ddcbc907-8cda-4145-bb4f-1d0d3f419554.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Octane-1-thiol,111-88-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97ab82cf-5310-4402-bcc3-2ccd4828d4b4/documents/IUC5-b49d8ace-75e8-409b-89c3-ec27026b8228_ddcbc907-8cda-4145-bb4f-1d0d3f419554.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,20 mg/m3,,mouse Octane-1-thiol,111-88-6,"Key data were identified to evaluate the acute oral, dermal, and inhalation toxicity potential of octane-1-thiol. The key parameters are discussed below :• Acute oral LD50: >2000 mg/kg bw • Acute dermal LD50: >2000 mg/kg bw• Acute inhalation LC50: >3.1 mg/L ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97ab82cf-5310-4402-bcc3-2ccd4828d4b4/documents/IUC5-81e1c4af-6bae-4982-a765-7b2082d090f8_ddcbc907-8cda-4145-bb4f-1d0d3f419554.html,,,,,, Octane-1-thiol,111-88-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97ab82cf-5310-4402-bcc3-2ccd4828d4b4/documents/IUC5-81e1c4af-6bae-4982-a765-7b2082d090f8_ddcbc907-8cda-4145-bb4f-1d0d3f419554.html,,oral,LD50,"2,000 mg/kg bw",, Octane-1-thiol,111-88-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97ab82cf-5310-4402-bcc3-2ccd4828d4b4/documents/IUC5-81e1c4af-6bae-4982-a765-7b2082d090f8_ddcbc907-8cda-4145-bb4f-1d0d3f419554.html,,dermal,LD50,"2,000 mg/kg bw",, Octane-1-thiol,111-88-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97ab82cf-5310-4402-bcc3-2ccd4828d4b4/documents/IUC5-81e1c4af-6bae-4982-a765-7b2082d090f8_ddcbc907-8cda-4145-bb4f-1d0d3f419554.html,,inhalation,LC50,3.1 mg/m3,, "6,8-disulfanyloctanoic acid",462-20-4, A acute oral toxicity study according to OECD 401 is available. The acute oral median lethal dose (LD50) in female rats was calculated to be 576 mg/kg bodyweight ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8e379df-8f1f-49b7-ac3d-052e4200c5fa/documents/IUC5-bf20a61d-c744-48ac-8859-047e5815e655_a3b5ec8c-2c80-4d45-a9c4-80f674a1adcd.html,,,,,, "6,8-disulfanyloctanoic acid",462-20-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8e379df-8f1f-49b7-ac3d-052e4200c5fa/documents/IUC5-bf20a61d-c744-48ac-8859-047e5815e655_a3b5ec8c-2c80-4d45-a9c4-80f674a1adcd.html,,oral,LD50,576 mg/kg bw,adverse effect observed, "Octanoic acid, compound with dicyclohexylamine (1:1)",15816-71-4," In aqueous systems Octanoic acid, compound with dicyclohexylamine (1:1) is hydrolytically very unstable so that in aqueous solution a rapid decomposition to the educts can be observed. The substance will rapidly dissociate to octanoic acid and dicyclohexylamine. Therefore Octanoic acid, compound with dicyclohexylamine (1:1) is not stable at “standard” testing conditions representative for human and environmental exposure. Hence, it is fully justified to apply the read-across methodology by use of the respective data from the breakdown/decomposition products to describe the toxicological behaviour of the substance. Repeated dose toxicity data for octanoic acid: Subchronic oral toxicity: NOAEL >= 7000 mg/kg bw Chronic oral toxicity: NOAEL >= 8000 mg/kg bw Repeated dose toxicity data for dicyclohexylamine: subacute oral toxicity: NOAEL 20 mg/kg bw The NOAEL of 20 mg/kg bw for dicyclohexylamine is used as key value for chemical safety assessment. Since the substance to be registered is Octanoic acid, compound with N-cyclohexylcyclohexanamine (1:1) which will dissociate to 1 mol octanoic acid and 1 mol dicyclohexylamine, the NOAEL of dicyclohexylamine is calculated for the entire substance considering the molar mass of 325.5 g/mol (55.7% dicyclohexylamine). Therefore the NOAEL for Octanoic acid, compound with dicyclohexylamine (1:1) is 35.9 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eea87213-dea7-4d83-9f63-df4478bf0188/documents/96519dda-e9e6-44a3-afe1-729011167c03_883ea0f6-62f3-45ae-a050-70fca3034121.html,,,,,, "Octanoic acid, compound with dicyclohexylamine (1:1)",15816-71-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eea87213-dea7-4d83-9f63-df4478bf0188/documents/96519dda-e9e6-44a3-afe1-729011167c03_883ea0f6-62f3-45ae-a050-70fca3034121.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,35.9 mg/kg bw/day,,rat "Octanoic acid, compound with dicyclohexylamine (1:1)",15816-71-4," In aqueous systems Octanoic acid, compound with dicyclohexylamine (1:1) is hydrolytically very unstable so that in aqueous solution a rapid decomposition to the educts can be observed.The substance will rapidly dissociate to octanoic acid and dicyclohexylamine. The time of decomposition was estimated as < 8 minutes. Therefore Octanoic acid, compound with dicyclohexylamine (1:1) is not stable at “standard” testing conditions representative for human and environmental exposure. Hence, it is fully justified to apply the read-across methodology by use of the respective data from the breakdown/decomposition products to describe the toxicological behaviour of the substance to be registered. Octanoic acid: Acute toxicity oral: An evaluation of available acute oral toxicity data is given in the CLH-Report prepared by Umweltbundesamt GmbH on behalf of AT Competent Authority, Federal Ministry of Agriculture, Forestry, Environment and WaterManagement. No classification for acute oral toxicity is required. Also according to the HERA (Human Health Risk Assessment) Targeted Risk Assessmentf or fatty acids salts no classification is needed. Citation from HERA: ""The available data for fatty acids provide a clear picture of low acute toxicity for this class of chemicals. All oral LD50 values were greater than 2,000 mg/kg, with little mortality being observed even at the highest doses tested in the studies."" Acute Toxicity inhalation: 6 male or female Albino rabbits were exposed to saturated octanoic acid vapour for 4 hours  No mortality was observed. The LC50 was >5 ml/l Acute dermal toxicity: The acute dermal toxicity study in rats indicate an LD50 above 2000 mg/kg bw, which is above the LD50 range that may lead to classification in category 4 (1000 to 2000 mg/kg bw). DCHA: Acute oral toxicity: The acute oral toxicity of dicyclohexylamine was evaluated in male Wistar rats. The test substnace was administered oral by gavage at doses of 0.16, 0.18, 0.20, 0.25, 0.30 ml/mg/ bw to groups of 10 male animals. Signs of intoxication were tonical cramps, sedation, poor general condition. The LD50 was estimated as 200 mg/kg bw. Acute toxicity inhalation: In an acute inhalation toxicity study in 6 male New Zealand Albino rabbits the LC 50 of Dicyclohexylamine was determined as > 1.4 mg/l. Acute dermal toxicity: Groups of New Zealand White rabbits received 126 - 316 mg/kg bw undiluted dicyclohexylamine by dermal application for 24 hours and were then observed for 14 days. Signs of intoxication were reduced appetite and activity, increasing weakness, collapse, and death within 16 hours post application from 200 mg/kg bw upwards. The LD50 ranges between 200 and 316 mg/kg bw. The lowest respective LD50/LC50 is calculated for the entire substance considering the molar mass of 325.5 g/mol forOctanoic acid, compound with N-cyclohexylcyclohexanamine (1:1), 181.32 for DCHA and 144.21 for octanoic acid respectively. Therefore the respective LD50's/LC50 for Octanoic acid, compound with dicyclohexylamine (1:1) are: Acute oral toxicity: LD50: 359 mg/kg b.w. Acute dermal toxicity: LD50: 359 mg/kg b.w. Acute toxicity inhalation: As for both substances neither mortality, nor significant clinical signs or pathological findings are reported at the highest doses apllied the LC50 for Octanoic acid, compound with dicyclohexylamine (1:1) is set as > 5 mg/l. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eea87213-dea7-4d83-9f63-df4478bf0188/documents/dbef1a57-70ee-497e-80f3-bb884c9ddd6f_883ea0f6-62f3-45ae-a050-70fca3034121.html,,,,,, "Octanoic acid, compound with dicyclohexylamine (1:1)",15816-71-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eea87213-dea7-4d83-9f63-df4478bf0188/documents/dbef1a57-70ee-497e-80f3-bb884c9ddd6f_883ea0f6-62f3-45ae-a050-70fca3034121.html,,oral,LD50,359 mg/kg bw,adverse effect observed, "Octanoic acid, compound with dicyclohexylamine (1:1)",15816-71-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eea87213-dea7-4d83-9f63-df4478bf0188/documents/dbef1a57-70ee-497e-80f3-bb884c9ddd6f_883ea0f6-62f3-45ae-a050-70fca3034121.html,,dermal,LD50,359 mg/kg bw,adverse effect observed, "Octanoic acid, compound with dicyclohexylamine (1:1)",15816-71-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eea87213-dea7-4d83-9f63-df4478bf0188/documents/dbef1a57-70ee-497e-80f3-bb884c9ddd6f_883ea0f6-62f3-45ae-a050-70fca3034121.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Octanoic acid, compound with octylamine (1:1)",17463-34-2,"Oral:-rat, LD50 (Dodecylamine): >2000 mg/kg-rat, LD50 (coco alkylamines): > 2000 mg/kg-rat, LD50 (octanoic acid): 1410 mg/kg-rat, LD50 (coco alkylamines): 1300 mg/kg-rat, LD50 (Octylamine): 200- 500 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd2fa524-f3b9-447d-80e3-3cb2b35261af/documents/IUC5-aef52be2-015d-49f6-bc2d-6e5170df27f2_2dfff24f-dbe3-488b-8951-a7e6b825e4b7.html,,,,,, "Octanoic acid, ester with 1,2,3-propanetriol",11140-04-8,"Studies on oral repeated dose toxicity were available for the following Category members (CAS No.): 73398-61-5, 8001-79-4, 91845 -19-1 and for medium- and long-chain triglyceride mixtures. All available studies resulted in oral NOAELs of 1000 mg/kg bw/d or greater than 1000 mg/kg bw/d.Studies on dermal repeated dose toxicity were available for the following Category member (CAS No.): 73398-61-5.A subacute (28 days) dermal NOAEL of 2000 mg/kg bw/d for rabbits was reported. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/784492b2-5f35-4d3f-84ba-096202a3856d/documents/c5020263-7f4c-44dc-9780-8935a94daae8_9bf1bdc2-0e9e-469c-97e0-646993afc2b6.html,,,,,, "Octanoic acid, ester with 1,2,3-propanetriol",11140-04-8," The acute oral median lethal dose (LD50) of the test material, octanoic acid, ester with 1,2,3 -propanetriol, to the rat was found to be greater than 2000 mg/kg bodyweight. All available acute toxicity studies within this Category showed that Fatty Acid Glycerides are non-toxic via the oral or dermal exposure route. Studies on acute oral toxicity were available for the following members of this category (CAS No.): 26402-26-6, 73398-61-5 and medium and long chain triglycerols (MLCT). The acute oral LD50 for rats and mice in all studies was found to be greater than 2000 or 5000 mg/kg bw. Studies on acute dermal toxicity were available for the following members of this category (CAS No.): 91845-19-1, 555-43-1, 620-67-7, 91052-13-0. The acute dermal LD50 in rats in all studies was found to be greater than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/784492b2-5f35-4d3f-84ba-096202a3856d/documents/032c1894-befa-48be-8814-27f22861028e_9bf1bdc2-0e9e-469c-97e0-646993afc2b6.html,,,,,, "Octanoic acid, mixed tetraesters with 2-ethylhexanoic acid, heptanoic acid and pentaerythritol",667899-24-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca7413d5-e80f-4a6d-bc0f-a6731a1db35a/documents/23e5bd3e-2e2c-4d2b-808a-84e6b5046887_f7234182-1c73-4043-a447-9bb5f75f20f0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Octanoic acid, mixed tetraesters with 2-ethylhexanoic acid, heptanoic acid and pentaerythritol",667899-24-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca7413d5-e80f-4a6d-bc0f-a6731a1db35a/documents/9154aa38-5a34-4e60-acd7-a8a2f51eeddf_f7234182-1c73-4043-a447-9bb5f75f20f0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Octanoic acid, zinc salt, basic",90480-58-3," No repeated dose toxicity study with Octanoic acid, zinc salt, basic is available, thus the repeated dose toxicity will be addressed with existing data on the moieties liberated upon dissolution, zinc and octanoic acid. In relevant and reliable repeated dose toxicity studies for the moiety zinc of Octanoic acid, zinc salt, basic and in peer-reviewed publicly available assessment reports for the moiety octanoic acid, there were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c308917b-4148-4c54-86a0-257fac046f8b/documents/IUC5-7bea2ad9-add0-4fea-81fe-9b5baacb34b9_1d9254c5-4a93-4d1e-ae92-76976d2dcf96.html,,,,,, "Octanoic acid, zinc salt, basic",90480-58-3," Acute oral toxicity (OECD 423; GLP): LD50 > 2000mg/kg   No acute dermal or inhalation toxicity studies with Octanoic acid, zinc salt, basic are available, thus the acute dermal and inhalation toxicity will be addressed with existing data on the dissociation products zinc and octanoic acid and with existing data on structurally similar zinc salts of fatty acids. Signs of acute dermal toxicity are not expected for Octanoic acid, zinc salt, basic, since the acute dermal toxicity for the moiety zinc can be considered low in view of the poor absorption by this route and the moiety zinc has not shown signs of acute dermal toxicity in experimental testing and in peer-reviewed publicly available assessment reports there were no toxicological findings reported for the moiety octanoic acid.   A study for acute toxicity via inhalation was not conducted with Octanoic acid, zinc salt, basic, since it is produced and placed on the market in a form in which no inhalation hazard is anticipated, thus acute toxic effects are not likely to occur during manufacture and handling of that substance.   The calculated oral and dermal LD50 for Octanoic acid, zinc salt, basic is > 2000mg/kg, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral and dermal toxicity as well as for specific target organ toxicity, single exposure (STOT SE). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c308917b-4148-4c54-86a0-257fac046f8b/documents/IUC5-901bf63e-41d7-416c-ade6-08fe7207490b_1d9254c5-4a93-4d1e-ae92-76976d2dcf96.html,,,,,, "Octanoic acid, zinc salt, basic",90480-58-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c308917b-4148-4c54-86a0-257fac046f8b/documents/IUC5-901bf63e-41d7-416c-ade6-08fe7207490b_1d9254c5-4a93-4d1e-ae92-76976d2dcf96.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Octaphenylcyclotetrasiloxane,546-56-5," In the key Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test, conducted according to OECD Test Guideline 422 and in compliance with GLP, the reported NOAEL value for octaphenylcyclotetrasiloxane for repeated dose toxicity was ≥1000 mg/kg bw/day. No adverse effects were observed in any of the test animals (Charles River, 2017). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/23f82ba1-8dd1-4bb3-bc1d-838430482d4c/documents/41e1d683-d16e-4756-8f93-bb130a4a8e95_d59d4a3f-ca60-463a-bfdc-332c0ddd6d69.html,,,,,, Octaphenylcyclotetrasiloxane,546-56-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/23f82ba1-8dd1-4bb3-bc1d-838430482d4c/documents/41e1d683-d16e-4756-8f93-bb130a4a8e95_d59d4a3f-ca60-463a-bfdc-332c0ddd6d69.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Octaphenylcyclotetrasiloxane,546-56-5," In an acute oral toxicity study conducted according to OECD Test Guideline 423 and in compliance with GLP, the reported LD50 value for octaphenylcyclotetrasiloxane was >2000 mg/kg bw (HSRL, 2011). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23f82ba1-8dd1-4bb3-bc1d-838430482d4c/documents/a3617824-96e9-43ad-b45b-b05130b5a264_d59d4a3f-ca60-463a-bfdc-332c0ddd6d69.html,,,,,, Octaphenylcyclotetrasiloxane,546-56-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23f82ba1-8dd1-4bb3-bc1d-838430482d4c/documents/a3617824-96e9-43ad-b45b-b05130b5a264_d59d4a3f-ca60-463a-bfdc-332c0ddd6d69.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Octasodium 2-(6-(4-chloro-6-(3-(N-methyl-N-(4-chloro-6-(3,5-disulfonato-2-naphthylazo)-1-hydroxy-6-naphthylamino)-1,3,5-triazin-2-yl)aminomethyl)phenylamino)-1,3,5-triazin-2-ylamino)-3,5-disulfonato-1-hydroxy-2-naphthylazo)naphthalene-1,5-disulfonate",148878-21-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2263d85d-4911-4c6c-9e96-b1e591f45376/documents/8d9345d2-511d-437d-ae87-525987b1fc28_10174753-cb65-43f3-a16b-1943435dae7c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Octasodium 2,2'-[(2,2'-disulphonato[1,1'-biphenyl]-4,4'-diyl)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino(1-hydroxy-3-sulphonatonaphthalene-6,2-diyl)azo]]bisnaphthalene-1,5-disulphonate",68110-30-5," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target substance 1,5-Naphthalenedisulfonic acid, 2,2'-[(2,2'-disulfo[1,1'-biphenyl]-4,4'-diyl)bis[imino (6-chloro-1,3,5-triazine-4,2-diyl)imino (1-hydroxy-3-sulfo-6,2-naphthalenediyl)azo]]bis-, octasodium salt (68110-30-5) was estimated to be 7205.53 mg/kg bw,and for differentstudies available on the structurally similar read across substance C.I. Reactive Red 2 (17804-49-8) was considered to be 7460 mg/kg bw and for Reactive Red 33 (12237-01-3) was considered to be 5000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 1,5-Naphthalenedisulfonic acid, 2,2'-[(2,2'-disulfo[1,1'-biphenyl]-4,4'-diyl)bis[imino (6-chloro-1,3,5-triazine-4,2-diyl)imino (1-hydroxy-3-sulfo-6,2-naphthalenediyl)azo]]bis-, octasodium salt (68110-30-5) cannot be classified for acute oral toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/306b3db4-1dd6-4cbb-a2b7-6bea69164807/documents/e0d27a26-50a6-42ec-b66c-1b8fb5a2d5f3_c29dda23-9615-490b-91ad-d6ae1991dd6f.html,,,,,, "Octasodium 2,2'-[(2,2'-disulphonato[1,1'-biphenyl]-4,4'-diyl)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino(1-hydroxy-3-sulphonatonaphthalene-6,2-diyl)azo]]bisnaphthalene-1,5-disulphonate",68110-30-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/306b3db4-1dd6-4cbb-a2b7-6bea69164807/documents/e0d27a26-50a6-42ec-b66c-1b8fb5a2d5f3_c29dda23-9615-490b-91ad-d6ae1991dd6f.html,,oral,LD50,"7,205.53 mg/kg bw",no adverse effect observed, "Octasodium 2,2'-[1,4-phenylenebis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino(1-hydroxy-3,6-disulphonatonaphthalene-2,8-diyl)azo]]bisnaphthalene-1,5-disulphonate",71002-20-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): No deaths or toxicologicall significant observations at 5000 mg/kg. In a 14-day dose range finding toxicity study no mortality was observed up to and including 1000 mg/kg/day. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/114540b1-8d31-40d3-9cef-4a4a42a78ff5/documents/28f468cc-8ffd-4e87-ace8-4e7aaee89a74_80490649-b52d-44ce-9c90-ec5e3663c3b1.html,,,,,, "Octasodium 2,2'-[1,4-phenylenebis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino(1-hydroxy-3,6-disulphonatonaphthalene-2,8-diyl)azo]]bisnaphthalene-1,5-disulphonate",71002-20-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/114540b1-8d31-40d3-9cef-4a4a42a78ff5/documents/28f468cc-8ffd-4e87-ace8-4e7aaee89a74_80490649-b52d-44ce-9c90-ec5e3663c3b1.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Octasodium 7,7'-[(2,2'-disulphonato[1,1'-biphenyl]-4,4'-diyl)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino[2-(carbamoylamino)]-4,1-phenylene]azo]]bis(naphthalene-1,3,6-trisulphonate)",68133-40-4,"OECD 423, LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b155f9a-d033-4f95-9072-bb81a1492b8b/documents/IUC5-e9a57ff4-9f3a-4d49-a5f6-193d45ead1d5_0e85e16a-2241-4380-bf67-f738d52680c0.html,,,,,, "Octasodium 7,7'-[(2,2'-disulphonato[1,1'-biphenyl]-4,4'-diyl)bis[imino(6-chloro-1,3,5-triazine-4,2-diyl)imino[2-(carbamoylamino)]-4,1-phenylene]azo]]bis(naphthalene-1,3,6-trisulphonate)",68133-40-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b155f9a-d033-4f95-9072-bb81a1492b8b/documents/IUC5-e9a57ff4-9f3a-4d49-a5f6-193d45ead1d5_0e85e16a-2241-4380-bf67-f738d52680c0.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Octene,25377-83-7," Guideline repeat dose toxicity studies in rats have been conducted for fourteen members of the higher olefin category, covering C6 to C20-24. The majority of these investigations (27 studies) have used oral (gavage) exposure, with three sub-acute (28-day), nine screening (OECD 421/422), and seven sub-chronic (90-day) studies available for this route. Two sub-acute dermal, two sub-acute inhalation and one sub-chronic inhalation tests, are also available; eight short-term repeat dose range-finding studies are also available. For the oral studies, systemic toxicity findings were typically limited to body weight, liver changes, and effects on clinical chemistry parameters as well as organ weights. Some of the effects observed were adaptive rather than adverse. While most of the studies revealed no systemic toxicity at doses up to 1000 mg/Kg bw/day, a conservative NOAEL for this category was determined to be 100 mg/Kg bw/day, based on minor effects observed with some category members.   The inhalation toxicity NOAEC was determined to be 3,000 ppm (10,326 mg/m3).    The available dermal studies are considered inadequate for the purposes of hazard identification but sufficient oral and inhalation studies are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e36c114-20d6-4d2e-b3f0-c4653967e4d8/documents/IUC5-0ae5c41d-91bb-4f20-a06f-41a111578894_8bbfd7cb-dbcc-4dce-8462-f60638ccd355.html,,,,,, Octene,25377-83-7,"Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e36c114-20d6-4d2e-b3f0-c4653967e4d8/documents/IUC5-8a1d4292-093b-40cd-9aab-a72431b17729_8bbfd7cb-dbcc-4dce-8462-f60638ccd355.html,,,,,, "Octene, hydroformylation products, high-boiling",68526-89-6,Oral: NOAEL > 1000 mg/kg bw; rat; 90d; according to OECD 408; GLP; K1 Inhalation: no information available Dermal: no information available ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/352edde4-1ebb-4739-b84f-3ed60a00b007/documents/IUC5-c55b2167-af0d-478a-b6d8-1b1d165e844c_9a951aaf-f62b-4dd8-8af1-affd1fc016c5.html,,,,,, "Octene, hydroformylation products, high-boiling",68526-89-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/352edde4-1ebb-4739-b84f-3ed60a00b007/documents/IUC5-c55b2167-af0d-478a-b6d8-1b1d165e844c_9a951aaf-f62b-4dd8-8af1-affd1fc016c5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Octene, hydroformylation products, high-boiling",68526-89-6,Oral: LD50 > 2000 mg/kg bw; rat; according to OECD TG 420; GLP; K1 Inhalation: no information available Dermal: LD50 > 2000 mg/kg bw; rat; according to OECD TG 402; GLP; K1 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/352edde4-1ebb-4739-b84f-3ed60a00b007/documents/IUC5-158fc353-cdc4-4754-b802-ef079b72ed1f_9a951aaf-f62b-4dd8-8af1-affd1fc016c5.html,,,,,, "Octene, hydroformylation products, high-boiling",68526-89-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/352edde4-1ebb-4739-b84f-3ed60a00b007/documents/IUC5-158fc353-cdc4-4754-b802-ef079b72ed1f_9a951aaf-f62b-4dd8-8af1-affd1fc016c5.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Octene, hydroformylation products, high-boiling",68526-89-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/352edde4-1ebb-4739-b84f-3ed60a00b007/documents/IUC5-158fc353-cdc4-4754-b802-ef079b72ed1f_9a951aaf-f62b-4dd8-8af1-affd1fc016c5.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Octene, hydroformylation products, low-boiling",68938-03-4," In the systemic toxicity element of an OECD 422 study in rats, the repeated dose oral NOAEL for Oxooil LS9 is 100 mg/kg bw/day. In a 90-day repeated dose toxicity study it can be concluded that the high dose of 200 mg/kg/day may be considered as the NOAEL. The substance is considered to be a low toxic risk by both the dermal and inhalation routes of exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0642620-62af-4001-ac35-45d0f834136e/documents/IUC5-9e73b97f-111a-4cf1-9766-7107725a650f_40519f05-560b-4150-8c56-a64067d01da1.html,,,,,, "Octene, hydroformylation products, low-boiling",68938-03-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0642620-62af-4001-ac35-45d0f834136e/documents/IUC5-9e73b97f-111a-4cf1-9766-7107725a650f_40519f05-560b-4150-8c56-a64067d01da1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Octene, hydroformylation products, low-boiling",68938-03-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0642620-62af-4001-ac35-45d0f834136e/documents/IUC5-9e73b97f-111a-4cf1-9766-7107725a650f_40519f05-560b-4150-8c56-a64067d01da1.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat "Octene, hydroformylation products, low-boiling",68938-03-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0642620-62af-4001-ac35-45d0f834136e/documents/IUC5-9e73b97f-111a-4cf1-9766-7107725a650f_40519f05-560b-4150-8c56-a64067d01da1.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"15,000 mg/m3",no adverse effect observed,rat "Octene, hydroformylation products, low-boiling",68938-03-4,Acute oral toxicity to female rats > 2000 mg/kg bw.. Acute dermal toxicity to rats > 2000 mg/kg bw.. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0642620-62af-4001-ac35-45d0f834136e/documents/IUC5-e5b0e86b-3691-4625-8ff8-64636387ace0_40519f05-560b-4150-8c56-a64067d01da1.html,,,,,, "Octene, hydroformylation products, low-boiling",68938-03-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0642620-62af-4001-ac35-45d0f834136e/documents/IUC5-e5b0e86b-3691-4625-8ff8-64636387ace0_40519f05-560b-4150-8c56-a64067d01da1.html,,oral,LD50,"2,000 mg/kg bw",, "Octene, hydroformylation products, low-boiling",68938-03-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0642620-62af-4001-ac35-45d0f834136e/documents/IUC5-e5b0e86b-3691-4625-8ff8-64636387ace0_40519f05-560b-4150-8c56-a64067d01da1.html,,dermal,LD50,"2,000 mg/kg bw",, Octyl (R)-2-(4-chloro-2-methylphenoxy)propionate,66423-13-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6aac1a5-467b-4cf8-b318-09adb7ec5873/documents/IUC5-8946bbd0-85c5-4379-8572-d41a3e792147_e0a3db82-a04e-4aed-b22a-123f439fda2a.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",, Octyl (R)-2-(4-chloro-2-methylphenoxy)propionate,66423-13-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6aac1a5-467b-4cf8-b318-09adb7ec5873/documents/IUC5-8946bbd0-85c5-4379-8572-d41a3e792147_e0a3db82-a04e-4aed-b22a-123f439fda2a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat Octyl (R)-2-(4-chloro-2-methylphenoxy)propionate,66423-13-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6aac1a5-467b-4cf8-b318-09adb7ec5873/documents/IUC5-f2e75d5d-d6ba-4d26-9732-4162456a3da8_e0a3db82-a04e-4aed-b22a-123f439fda2a.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Octyl (R)-2-(4-chloro-2-methylphenoxy)propionate,66423-13-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6aac1a5-467b-4cf8-b318-09adb7ec5873/documents/IUC5-f2e75d5d-d6ba-4d26-9732-4162456a3da8_e0a3db82-a04e-4aed-b22a-123f439fda2a.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Octyl methacrylate,2157-01-9," For the endpoint repeated dose toxicity no study is available with n-octyl methacrylate. Therefore a read across using the category approach lower alkyl (C1 -C8) methacrylates was used to predict the repeated dose toxicity of n-octyl methacrylate. As source substances 2-ethylhexyl methacrylate was chosen. In an oral OECD 408 study performed according GLP, the no observed adverse effect level (NOAEL) of 2 -Ethylhexyl methacrylate was 120 mg/kg body weight/day in male and female Wistar rats (BASF, 2009). Data on the primary metabolites methacrylic acid and 2-ethylhexanol do not reveal critical effects like specific target organ toxicity. Toxicity of 2-ethylhexanol is lower than the parent ester toxicity based on NOAELs. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc5f2259-aec1-4002-9463-f4e255f8ec30/documents/333e07f0-fc2a-4c3b-970f-af87db76d21a_0e1480c1-6e2a-4a0e-afb0-4f41b9b1d506.html,,,,,, Octyl methacrylate,2157-01-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/dc5f2259-aec1-4002-9463-f4e255f8ec30/documents/333e07f0-fc2a-4c3b-970f-af87db76d21a_0e1480c1-6e2a-4a0e-afb0-4f41b9b1d506.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat Octyl methacrylate,2157-01-9," There are no reliable data available for acute oral, inhalative and dermal toxicity of n-octyl methacrylate. However, methyl- and n-butyl methacrylate, and 2-ethylhexyl methacrylate analogue substances and members of the category C1 -C8 lower alkyl methacrylates are of low toxicity (LD0/rabbit >= 2000 mg/kg) by the dermal route and oral route (LD50/rat: >= 2000 mg/kg). As well, methyl-, ethyl- and n-butyl methacrylate are also of low acute inhalation toxicity with 4-h LC50 in rats of 28.9, 55.0 and 29.0 mg/l, respectively. Due to the low vapour pressure, inhalation is not considered as a relevant route of exposure for n-octyl methacrylate. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc5f2259-aec1-4002-9463-f4e255f8ec30/documents/06efecbe-0eb0-4ded-8603-888e02354a9b_0e1480c1-6e2a-4a0e-afb0-4f41b9b1d506.html,,,,,, Octyl methacrylate,2157-01-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc5f2259-aec1-4002-9463-f4e255f8ec30/documents/06efecbe-0eb0-4ded-8603-888e02354a9b_0e1480c1-6e2a-4a0e-afb0-4f41b9b1d506.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Octyloxirane,2404-44-6,The NOAEL for oral repeated dose toxicity was determined to be 750 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf222a06-4356-449b-8642-11d7b96b4298/documents/706486d1-a809-409b-afae-7a3c99f369d9_e649a3e6-6912-4237-b557-1342326d79cb.html,,,,,, Octyloxirane,2404-44-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf222a06-4356-449b-8642-11d7b96b4298/documents/706486d1-a809-409b-afae-7a3c99f369d9_e649a3e6-6912-4237-b557-1342326d79cb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat Octyloxirane,2404-44-6,The oral LD50 was determined to be >5000 mg/kg bw.The dermal LD50 was determined to be >2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf222a06-4356-449b-8642-11d7b96b4298/documents/54a12142-3884-4a44-9a2e-cdb83a19c43c_e649a3e6-6912-4237-b557-1342326d79cb.html,,,,,, Octyloxirane,2404-44-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf222a06-4356-449b-8642-11d7b96b4298/documents/54a12142-3884-4a44-9a2e-cdb83a19c43c_e649a3e6-6912-4237-b557-1342326d79cb.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Octyloxirane,2404-44-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf222a06-4356-449b-8642-11d7b96b4298/documents/54a12142-3884-4a44-9a2e-cdb83a19c43c_e649a3e6-6912-4237-b557-1342326d79cb.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Octylphosphonic acid,4724-48-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The studies are GLP compliant with a high quality (Klimisch score = 1). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63ab6ed9-bef2-4d28-935b-6792c1626be6/documents/1b76039a-4a5f-46c8-be0f-94e58e73c23c_9542e1f0-f6b8-4ae1-914f-92f2027094da.html,,,,,, Octylphosphonic acid,4724-48-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63ab6ed9-bef2-4d28-935b-6792c1626be6/documents/1b76039a-4a5f-46c8-be0f-94e58e73c23c_9542e1f0-f6b8-4ae1-914f-92f2027094da.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,12 mg/kg bw/day,,rat Octylphosphonic acid,4724-48-5,"The acute toxicity of octylphosphonic acid (OPA) has been studied by oral and dermal routes. For oral toxicity, the study by HOEC (1979) (Rel. 2) in rats has been chosen as key study. Based on the results of this study, OPA is classified into category 4, H302 according to EU Regulation criteria. The key study for dermal toxicity (Rel. 1) is Allen (1997). No study on acute inhalation toxicity is required since the substance is a waxy solid with very low vapour pressure, and is corrosive to the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63ab6ed9-bef2-4d28-935b-6792c1626be6/documents/0f47c4db-9e9c-43d4-8118-90d0c188278b_9542e1f0-f6b8-4ae1-914f-92f2027094da.html,,,,,, Octylphosphonic acid,4724-48-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63ab6ed9-bef2-4d28-935b-6792c1626be6/documents/0f47c4db-9e9c-43d4-8118-90d0c188278b_9542e1f0-f6b8-4ae1-914f-92f2027094da.html,,oral,LD50,"1,890 mg/kg bw",adverse effect observed, Octyltrichlorosilane,5283-66-9," In the key 90-day oral repeated dose toxicity study, conducted according to OECD Test Guideline 408 and in compliance with GLP, the NOAEL for systemic effects was concluded to be equal to or greater than 75 mg/kg bw/day based on no adverse systemic effects observed at any dose tested, while the NOAEL for local effects was concluded to be 10 mg/kg bw/day based on degenerative and inflammatory lesions in the stomachs of animals at 25 and 75 mg/kg bw/day (BSL Bioservice, 2021).  In a well conducted 90-day gas inhalation study (Toxigenics, 1984) the systemic NOAEC for hydrogen chloride was 20 ppm based on decreased body weight following exposure to 50 ppm (6 hours/day, 5 days/week) in rats and mice. The main adverse findings related to irritant/corrosive effects on the nasal turbinates in mice, which was observed with a LOAEC of 10 ppm. A good quality 90-day repeated inhalation study for hydrogen chloride has been used to assess the local effects of trichloro(octyl)silane. In a 90-day repeated inhalation study with HCl, no serious adverse systemic effects were observed in rats and mice exposed up to 50 ppm (approximately 70 mg/m3) for 6 hours per day, 5 days per week (Toxigenics, 1984). The only significant adverse finding relating to systemic toxicity was decreased body weight at the highest dose level. Local effects on the nasal turbinates of mice were observed at all dose levels tested (10, 20 and 50 ppm). Testing with HCl at higher test concentrations is neither ethically nor technically feasible since severe corrosive effects would lead to discomfort and distress in the test animals. The author of this CSR considers that the apparent systemic effects at 50 ppm in the study were most likely secondary to local corrosive effects at this dose level. Following uptake of HCl, hydrogen and chloride ions from will enter the body’s natural homeostatic processes and significant systemic effects are unlikely. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e87fd97-7821-4723-b2dc-08c60118838f/documents/c94f0486-670c-4a45-abf6-831e87537371_fb5b8a00-7189-4097-8a3e-ae3d3641b241.html,,,,,, Octyltrichlorosilane,5283-66-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8e87fd97-7821-4723-b2dc-08c60118838f/documents/c94f0486-670c-4a45-abf6-831e87537371_fb5b8a00-7189-4097-8a3e-ae3d3641b241.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 mg/m3,adverse effect observed,rat Octyltrichlorosilane,5283-66-9," There are no reliable acute toxicity data for trichloro(octyl)silane. However, in accordance with Column 2 of REACH Annexes VII and VIII, acute toxicity studies (required in Section 8.5) do not need to be conducted as the substance is classified as corrosive to skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8e87fd97-7821-4723-b2dc-08c60118838f/documents/6e03d8be-0c17-46b6-9a48-c66de1d406db_fb5b8a00-7189-4097-8a3e-ae3d3641b241.html,,,,,, "Oestr-5(10)-ene-3,17-dione",3962-66-1,"LD50 oral (rat): > 2000 mg/kg bw [Ihara 2004]LD50 dermal (rat): > 2000 mg/kg bw [Ihara 2004] Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): This study is GLP compliant and is of high quality (Klimisch Score = 1). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): This study is GLP compliant and is of high quality (Klimisch Score = 1). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd1f390a-94e4-4c34-8c9e-a5237a8f100c/documents/IUC5-36e5b229-f391-4f19-a23b-1149b5c4f036_dcbd1883-3dd5-44d9-8daa-1c80a7e43805.html,,,,,, "Oestr-5(10)-ene-3,17-dione",3962-66-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd1f390a-94e4-4c34-8c9e-a5237a8f100c/documents/IUC5-36e5b229-f391-4f19-a23b-1149b5c4f036_dcbd1883-3dd5-44d9-8daa-1c80a7e43805.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Oestr-5(10)-ene-3,17-dione",3962-66-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd1f390a-94e4-4c34-8c9e-a5237a8f100c/documents/IUC5-36e5b229-f391-4f19-a23b-1149b5c4f036_dcbd1883-3dd5-44d9-8daa-1c80a7e43805.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Oil shale, thermal processing waste",93685-99-5,"No studies via oral or dermal exposure are available for Burnt Oil Shale (BOS), and limited or no data are available on crystalline silica for the same exposure routes. Toxicokinetic data of crystalline silica suggest minimal absorption and bioavailability upon oral exposure and virtually no absorption via the dermal route.Lung inflammation, cellular proliferation and ultimately fibrosis are the main toxic effects most likely to occur after repeated short- and long-term exposure to respirable crystalline silica particles (MMAD < 5 µm). Animal dose-response data for crystalline silica are limited. The lowest published toxic concentration for chronic (two-year intermittent) inhalation exposure in rats was 0.74 mg/m³. However, human data indicate a significant risk of developing chronic silicosis at exposure levels as low as 0.05 mg/m³ in occupational settings. Therefore, 0.05 mg/m³ is regarded as the LOAEC for respirable crystalline silica. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f4ebaae-67f9-4ef9-a7b9-17cd52f689e9/documents/IUC5-0408e453-e0ee-4395-a445-23ac7215af5e_1e260490-d98f-4e96-b79e-de22b408c996.html,,,,,, "Oil shale, thermal processing waste",93685-99-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f4ebaae-67f9-4ef9-a7b9-17cd52f689e9/documents/IUC5-0408e453-e0ee-4395-a445-23ac7215af5e_1e260490-d98f-4e96-b79e-de22b408c996.html,Repeated dose toxicity – local effects,inhalation,LOAEC,0.05 mg/m3,adverse effect observed,other:epidemiological human data "Oil shale, thermal processing waste",93685-99-5,Burnt oil shale is non toxic via the oral route ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f4ebaae-67f9-4ef9-a7b9-17cd52f689e9/documents/IUC5-eeb86adb-5cb1-4b54-9b76-001987ce8708_1e260490-d98f-4e96-b79e-de22b408c996.html,,,,,, "Oil shale, thermal processing waste",93685-99-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f4ebaae-67f9-4ef9-a7b9-17cd52f689e9/documents/IUC5-eeb86adb-5cb1-4b54-9b76-001987ce8708_1e260490-d98f-4e96-b79e-de22b408c996.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Oils, animal, sulfated, sodium salts",94279-90-0,"Oils, fish, sulfated, sodium salts NOAEL (90d) = 1000 mg/kg/day   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/de89228c-e827-45d1-a690-9bc930d436d3/documents/IUC5-31d097aa-4f6a-4d25-9e0b-94e97524d3ae_ca5cfec5-ba1b-427f-b106-c55121bdfac6.html,,,,,, "Oils, animal, sulfated, sodium salts",94279-90-0,"FLL sample 4, limit test, LD50 oral and derma> 2000 mg/kg FLL sample 3, LD50 oral and dermal > 2000 mg/kg Oils fish sulphated sodium salt oral > 2000 mg/kg Oils rape sulphated sodium salt oral and dermal> 2000 mg/kg Acute toxicity inhalation: not relevant The more conservative 2000 mg/kg bw no effect levels from the more extensive read across studies was used as the starting point to derive DNELs for the sulfated fat liquors.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de89228c-e827-45d1-a690-9bc930d436d3/documents/IUC5-f410d170-d8c6-438e-8f3d-652ad678bd30_ca5cfec5-ba1b-427f-b106-c55121bdfac6.html,,,,,, "Oils, animal, sulfated, sodium salts",94279-90-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de89228c-e827-45d1-a690-9bc930d436d3/documents/IUC5-f410d170-d8c6-438e-8f3d-652ad678bd30_ca5cfec5-ba1b-427f-b106-c55121bdfac6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Oils, animal, sulfated, sodium salts",94279-90-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/de89228c-e827-45d1-a690-9bc930d436d3/documents/IUC5-f410d170-d8c6-438e-8f3d-652ad678bd30_ca5cfec5-ba1b-427f-b106-c55121bdfac6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Oils, animal, sulfonated, sodium salts",95371-11-2,"The subchronic oral toxicity on rats for the substance Triglycerides, C12-24, Even, Saturated and Unsaturated, Bisulfited, Sodium Salt (Animal) has been assessed on the analogue substance, fish derivatives, taken as representative for the category. Refer to the Read Across justification attached in section 13 for more details. The choice is supported by the result of subacute oral toxicity in rats, performed for all three derivatives of the FLL category (OECD 422), showing no effect at the highest tested limit dose of 1000 mg/kg bw/day Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Good ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f84d5877-0f0d-4bb2-8bf2-f33c59cb1f43/documents/ae545a3e-4b4b-48e2-9db7-965b1f1d09b9_4c82102b-01b6-4e49-aa58-d7b108245a7d.html,,,,,, "Oils, animal, sulfonated, sodium salts",95371-11-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f84d5877-0f0d-4bb2-8bf2-f33c59cb1f43/documents/ae545a3e-4b4b-48e2-9db7-965b1f1d09b9_4c82102b-01b6-4e49-aa58-d7b108245a7d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Oils, animal, sulfonated, sodium salts",95371-11-2,"Two acute oral toxicity studies using rats have been conducted for two of the FLL Samples with both indicating low toxicity with an LD50≥ 2000 mg/kg bw. In both tests, 2000 mg/kg bw was the highest dosing rate and no mortalities were observed at this dose, meaning that a NOAEL of 2000 mg/kg bw can also be inferred. The LD50 limit value does not fall below the criterion of 2000 mg/kg bw for Category 4 with respect to acute oral toxicity classification indicating that the FLL Substances do not pose an acute toxicity hazard.Two acute dermal toxicity studies using rats have been conducted for two of the FLL Samples with both indicating low toxicity with an LD50≥ 2000 mg/kg bw. In both tests, 2000 mg/kg bw was the highest dosing rate and no mortalities were observed at this dose, meaning that a NOAEL of 2000 mg/kg bw can also be inferred. The LD50 limit value does not fall below the criterion of 2000 mg/kg bw for Category 4 with respect to acute dermal toxicity classification indicating that the FLL Substances do not pose an acute toxicity hazard ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f84d5877-0f0d-4bb2-8bf2-f33c59cb1f43/documents/IUC5-3289a888-9e57-4b0f-bd3a-1777dcc269d2_4c82102b-01b6-4e49-aa58-d7b108245a7d.html,,,,,, "Oils, animal, sulfonated, sodium salts",95371-11-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f84d5877-0f0d-4bb2-8bf2-f33c59cb1f43/documents/IUC5-3289a888-9e57-4b0f-bd3a-1777dcc269d2_4c82102b-01b6-4e49-aa58-d7b108245a7d.html,,oral,LD50,"2,000 mg/kg bw",, "Oils, animal, sulfonated, sodium salts",95371-11-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f84d5877-0f0d-4bb2-8bf2-f33c59cb1f43/documents/IUC5-3289a888-9e57-4b0f-bd3a-1777dcc269d2_4c82102b-01b6-4e49-aa58-d7b108245a7d.html,,dermal,LD50,"2,000 mg/kg bw",, "Oils, fish, oxidized, bisulfited, sodium salts",97488-98-7,"The substance Triglycerides, C12-24, Even, Saturated and Unsaturated, Bisulfited, Sodium Salt (Fish) has been tested  for oral subchronic toxicity in rats according to OECD 408 up to 1000 mg/kg bw without any effect. The result is in agreement with the result of subacute oral toxicity in rats, for all three derivatives of the FLL category (OECD 422). NOAEL (90d) = 1000 mg/kg/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d101daf-97f5-446e-9719-01d30ade7af3/documents/0dc0be34-a5d2-4011-b9a0-20fd41fbf0eb_efd0be7a-f138-4919-9290-eee8bc1b29da.html,,,,,, "Oils, fish, oxidized, bisulfited, sodium salts",97488-98-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d101daf-97f5-446e-9719-01d30ade7af3/documents/0dc0be34-a5d2-4011-b9a0-20fd41fbf0eb_efd0be7a-f138-4919-9290-eee8bc1b29da.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Oils, fish, oxidized, bisulfited, sodium salts",97488-98-7,"Two acute oral toxicity studies using rats have been conducted for two of the FLL Samples with both indicating low toxicity with an LD50≥ 2000 mg/kg bw. In both tests, 2000 mg/kg bw was the highest dosing rate and no mortalities were observed at this dose, meaning that a NOAEL of 2000 mg/kg bw can also be inferred. The LD50 limit value does not fall below the criterion of 2000 mg/kg bw for Category 4 with respect to acute oral toxicity classification indicating that the FLL Substances do not pose an acute toxicity hazard.Two acute dermal toxicity studies using rats have been conducted for two of the FLL Samples with both indicating low toxicity with an LD50≥ 2000 mg/kg bw. In both tests, 2000 mg/kg bw was the highest dosing rate and no mortalities were observed at this dose, meaning that a NOAEL of 2000 mg/kg bw can also be inferred. The LD50 limit value does not fall below the criterion of 2000 mg/kg bw for Category 4 with respect to acute dermal toxicity classification indicating that the FLL Substances do not pose an acute toxicity hazard ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d101daf-97f5-446e-9719-01d30ade7af3/documents/0b2cea6a-f488-4068-8c6a-e153f01c0cd1_efd0be7a-f138-4919-9290-eee8bc1b29da.html,,,,,, "Oils, fish, oxidized, bisulfited, sodium salts",97488-98-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d101daf-97f5-446e-9719-01d30ade7af3/documents/0b2cea6a-f488-4068-8c6a-e153f01c0cd1_efd0be7a-f138-4919-9290-eee8bc1b29da.html,,oral,LD50,"2,000 mg/kg bw",, "Oils, fish, oxidized, bisulfited, sodium salts",97488-98-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d101daf-97f5-446e-9719-01d30ade7af3/documents/0b2cea6a-f488-4068-8c6a-e153f01c0cd1_efd0be7a-f138-4919-9290-eee8bc1b29da.html,,dermal,LD50,"2,000 mg/kg bw",, "Oils, fish, sulfated, sodium salts",61788-64-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3357621a-5454-42c3-b0f9-526b9dab2a7c/documents/e138db6b-e45a-415c-8179-1357d7b10df1_1d0d22f8-9ddb-4739-8ad3-b5276503040e.html,,,,,, "Oils, fish, sulfated, sodium salts",61788-64-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3357621a-5454-42c3-b0f9-526b9dab2a7c/documents/e138db6b-e45a-415c-8179-1357d7b10df1_1d0d22f8-9ddb-4739-8ad3-b5276503040e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Oils, fish, sulfated, sodium salts",61788-64-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Quality of the data base is not very high, but enough to assess acute toxicity of the substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3357621a-5454-42c3-b0f9-526b9dab2a7c/documents/IUC5-124e0a54-7d0d-43b2-83c4-065f7cf4af57_1d0d22f8-9ddb-4739-8ad3-b5276503040e.html,,,,,, "Oils, fish, sulfated, sodium salts",61788-64-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3357621a-5454-42c3-b0f9-526b9dab2a7c/documents/IUC5-124e0a54-7d0d-43b2-83c4-065f7cf4af57_1d0d22f8-9ddb-4739-8ad3-b5276503040e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Oils, fish, sulfated, sodium salts",61788-64-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3357621a-5454-42c3-b0f9-526b9dab2a7c/documents/IUC5-124e0a54-7d0d-43b2-83c4-065f7cf4af57_1d0d22f8-9ddb-4739-8ad3-b5276503040e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Oils, lard, sulfated, ammonium salts",91079-06-0,Sub-acute toxicity: NOAEL - Males and females: 1000 mg/kg/day ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0011f2d5-aea9-4a5a-a016-aafcd0311679/documents/f165be58-7e0b-4365-a32c-3bc9b56b1ccf_a73dbdc4-4e16-4dcb-b3f5-a467332f39b8.html,,,,,, "Oils, lard, sulfated, ammonium salts",91079-06-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0011f2d5-aea9-4a5a-a016-aafcd0311679/documents/f165be58-7e0b-4365-a32c-3bc9b56b1ccf_a73dbdc4-4e16-4dcb-b3f5-a467332f39b8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Oils, lard, sulfated, ammonium salts",91079-06-0,- Acute toxicity:Oral: LD50: >2000 mg/kg in the ratDermal: LD50: > 2000 mg/kg in the rat ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0011f2d5-aea9-4a5a-a016-aafcd0311679/documents/e14e1d88-b3dc-4b25-a005-5ffa0e462d25_a73dbdc4-4e16-4dcb-b3f5-a467332f39b8.html,,,,,, "Oils, lard, sulfated, ammonium salts",91079-06-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0011f2d5-aea9-4a5a-a016-aafcd0311679/documents/e14e1d88-b3dc-4b25-a005-5ffa0e462d25_a73dbdc4-4e16-4dcb-b3f5-a467332f39b8.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Oils, lard, sulfated, ammonium salts",91079-06-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0011f2d5-aea9-4a5a-a016-aafcd0311679/documents/e14e1d88-b3dc-4b25-a005-5ffa0e462d25_a73dbdc4-4e16-4dcb-b3f5-a467332f39b8.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "oils, palm, propoxylated",512802-65-2," In a reliable repeated dose oral toxicity study in rats the NOAEL for a structurally similar substance was considered to be 1000 mg/kg bw/day (the highest dose tested). The slight changes in thyroids of females at 1000 mg/kg were related to the treatment, but they are regarded as an indirect and adaptive effect. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf0e6b9f-7702-4619-96b6-93417f5d1f7a/documents/19b3d6d0-db4b-41da-8d58-c1080ffc4a7c_f99c6e79-86fe-4c86-b183-50f62a46346b.html,,,,,, "oils, palm, propoxylated",512802-65-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf0e6b9f-7702-4619-96b6-93417f5d1f7a/documents/19b3d6d0-db4b-41da-8d58-c1080ffc4a7c_f99c6e79-86fe-4c86-b183-50f62a46346b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "oils, palm, propoxylated",512802-65-2," In a reliable acute oral toxicity study the substance was administered to Wistar rats (5 animals/sex/dose) by oral gavage at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was as expected and no abnormalities found at macroscopic post-mortem examination.The oral LD50 is >2000 mg/kg bw. In a reliable acute oral toxicity study a structurally similar substance was administered to Sprague Dawley rats (6 animals) by oral gavage at a dose level of 2000 mg/kg bw (single administration). The oral LD50 is >2500 mg/kg bw. In a reliable acute dermal toxicity study a structurally similar substance was administered to Sprague Dawley rats (5 animals/sex) by semi-occluded dermal application for 24 hours at a dose level of 2000 mg/kg bw (single administration). The dermal LD50 is >2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf0e6b9f-7702-4619-96b6-93417f5d1f7a/documents/9d543fdc-cc3f-4d01-9e1c-3dd1c6211b53_f99c6e79-86fe-4c86-b183-50f62a46346b.html,,,,,, "oils, palm, propoxylated",512802-65-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf0e6b9f-7702-4619-96b6-93417f5d1f7a/documents/9d543fdc-cc3f-4d01-9e1c-3dd1c6211b53_f99c6e79-86fe-4c86-b183-50f62a46346b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "oils, palm, propoxylated",512802-65-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf0e6b9f-7702-4619-96b6-93417f5d1f7a/documents/9d543fdc-cc3f-4d01-9e1c-3dd1c6211b53_f99c6e79-86fe-4c86-b183-50f62a46346b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Oils, vegetable, deodorizer distillates",68476-80-2," The repeated dose toxicity potential of ‘oils, vegetable, deodorizer distillates’ can be deduced based on information available for its individual constituents. Studies conducted with the two main constituents, glycerides and fatty acids, indicate overall low toxicity. The highest free-standing NOAEL from a chronic repeated dose oral toxicity was equivalent to18.5% in diet, i.e., equivalent to 9,250 mg/kg bw/day. The sterols, sterol esters and squalene are unlikely to contribute significantly to toxicity as they were found to be poorly absorbed through oral as well as dermal routes. Tocopherols, on the other hand, were well absorbed and although beneficial at nutritionally relevant doses, may antagonise the function of other fat-soluble vitamins at higher doses. Considering the available dermal studies with some of the constituents together with their absorption potential, toxicity of the individual constituents via the dermal route is not expected to be higher than oral route. Exposure via the inhalation route is not expected considering the low vapour pressure of the substance. Further, the inhalation exposure potential in workers where the substance is handled in aerosolized or spray form is considered to be low due to implementation of strict risk management measures at workplace (See sections 9 and 10 of the CSR). Therefore, repeated dose inhalation toxicity is not expected to pose an issue for human health and no further testing is required for this endpoint, in accordance with Annex VIII, column 2 of the REACH regulation. Alternative text: Chronic and sub-chronic dietary studies were conducted in rodents with various glycerides and fatty acids which are representative of the REVODS category members and covering the fatty acid chain length of C8 to C18. In these studies, no treatment-related effects were seen in the test animals due to supplementation of the diet with these substances and consequently, the no observed effect levels for these studies were the respective highest tested dose levels. For perspective, the highest free standing NOAEL from the long term studies is 18.5% in diet from the 47-week study with coconut oil, equivalent to 9250 mg/kg bw/day (Harkins, 1968). This NOAEL is supported by free standing NOAELs from other chronic and sub-chronic studies (Morin, 1967; Nolen, 1981; Speijers, 2009; Coquet, 1977 and Manorama and Rukmini, 1991). The tocopherols, in general, contribute less to the composition of deodorizer distillates than the phytosterols and sterol esters. The sterols and sterol esters are generally poorly absorbed from the gastro-intestinal tract and slowly absorbed through the skin. As a result, inspite of their relative greater extent of absorption through oral well as dermal routes, overall contribution of the tocopherols to the systemic dose of the deodorizer distillates could be considered to be low. On the other hand, major constituents of the deodorizer distillates are glycerides and fatty acids of C8 to C18 chain length. Systemic absorption of the shorter chain fatty acids is greater than the longer chain counterparts. Therefore, C8-C12 fatty acids could be considered to show higher degree of systemic absorption compared to the longer chains. With this in mind, coconut oil (rich in C12 and C14 fatty acids) as a representative of the constituent glycerides, C8 -18 and C18 -unsatd.’ would be appropriate and studies conducted with coconut oil as test substance can be regarded as major contributor in the evaluation of repeated dose exposure. Considering the available dermal studies with some of the constituents together with their absorption potential, toxicity of the individual constituents via the dermal route is not expected to be higher than oral route. Exposure via the inhalation route is not expected considering the low vapour pressure of the substance. Further, the inhalation exposure potential in workers where the substance is handled in aerosolized or spray form is considered to be low due to implementation of strict risk management measures at workplace (See sections 9 and 10 of the CSR). Therefore, repeated dose inhalation toxicity is not expected to pose an issue for human health and no further testing is required for this endpoint, in accordance with Annex VIII, column 2 of the REACH regulation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f877023-d8ea-4409-853e-6b976ccd2bfd/documents/IUC5-70d1dcad-cb42-4743-bde5-6aae735fb057_531e78b9-f129-4424-bc5e-8abba37d26b1.html,,,,,, "Oils, vegetable, deodorizer distillates",68476-80-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f877023-d8ea-4409-853e-6b976ccd2bfd/documents/IUC5-70d1dcad-cb42-4743-bde5-6aae735fb057_531e78b9-f129-4424-bc5e-8abba37d26b1.html,Chronic toxicity – systemic effects,oral,NOAEL,"9,250 mg/kg bw/day",,rat "Oils, vegetable, deodorizer distillates",68476-80-2," Overall weight of evidence from different studies suggests that the main constituents of ‘oils, vegetable, deodorizer distillates’ have low acute toxicity following oral and dermal exposure, with LD50 values greater than 2,000 mg/kg. This is in line with their long history of safe use in a wide range of nutritional (food and feed), cosmetic and/or industrial applications. The exposure via the inhalation route is not expected given the low vapour pressure of the substance. Further, the likely inhalation exposure potential in workers where the substance is handled in aerosolized or spray form is considered to be low due implementation of strict risk management measures in workplace (See sections 9 and 10 of the CSR). Therefore, acute inhalation exposure is not expected to pose an issue for human health and no further testing is required for this endpoint according to Annex VIII, Section 8.5, column 2 of the REACH legislation. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f877023-d8ea-4409-853e-6b976ccd2bfd/documents/IUC5-09ed7b17-a0a6-45e1-bf94-20e683acc51c_531e78b9-f129-4424-bc5e-8abba37d26b1.html,,,,,, "Oils, vegetable, deodorizer distillates",68476-80-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f877023-d8ea-4409-853e-6b976ccd2bfd/documents/IUC5-09ed7b17-a0a6-45e1-bf94-20e683acc51c_531e78b9-f129-4424-bc5e-8abba37d26b1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Oils, vegetable, deodorizer distillates",68476-80-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f877023-d8ea-4409-853e-6b976ccd2bfd/documents/IUC5-09ed7b17-a0a6-45e1-bf94-20e683acc51c_531e78b9-f129-4424-bc5e-8abba37d26b1.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Oils, vegetable, sulfated",61790-19-0,"OECD 408: NOAEL (90d, rat) > 1000 mg/kg/day   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86e585c1-35b6-4598-96d8-f85bfac01330/documents/IUC5-9296d221-077e-4cc3-ab0d-107a2d2e6665_8317bc7d-df08-424e-abf3-05b32200016d.html,,,,,, "Oils, vegetable, sulfated",61790-19-0,"FLL sample 4, limit test, LD50 oral and derma> 2000 mg/kg FLL sample 3, LD50 oral and dermal > 2000 mg/kg Oils fish sulphated sodium salt oral > 2000 mg/kg Oils rape sulphated sodium salt oral and dermal> 2000 mg/kg Acute toxicity inhalation: not relevant The more conservative 2000 mg/kg bw no effect levels from the more extensive read across studies was used as the starting point to derive DNELs for the sulfated fat liquors.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86e585c1-35b6-4598-96d8-f85bfac01330/documents/IUC5-84a1a79a-76a3-4a69-8c79-575b94a8b965_8317bc7d-df08-424e-abf3-05b32200016d.html,,,,,, "Oils, vegetable, sulfated",61790-19-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86e585c1-35b6-4598-96d8-f85bfac01330/documents/IUC5-84a1a79a-76a3-4a69-8c79-575b94a8b965_8317bc7d-df08-424e-abf3-05b32200016d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Oils, vegetable, sulfated",61790-19-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86e585c1-35b6-4598-96d8-f85bfac01330/documents/IUC5-84a1a79a-76a3-4a69-8c79-575b94a8b965_8317bc7d-df08-424e-abf3-05b32200016d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Oils, vegetable, sulfonated, sodium salts",97489-04-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/baec9f9c-de89-4345-b8c1-544a780c16f5/documents/IUC5-6be67fcd-3e3c-4229-8384-1e43f1cb6851_a8c8003d-c347-48e4-a87f-c50b48b19884.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Oils, vegetable, sulfonated, sodium salts",97489-04-8,"Two acute oral toxicity studies using rats have been conducted for two of the FLL Samples with both indicating low toxicity with an LD50≥ 2000 mg/kg bw. In both tests, 2000 mg/kg bw was the highest dosing rate and no mortalities were observed at this dose, meaning that a NOAEL of 2000 mg/kg bw can also be inferred. The LD50 limit value does not fall below the criterion of 2000 mg/kg bw for Category 4 with respect to acute oral toxicity classification indicating that the FLL Substances do not pose an acute toxicity hazard.Two acute dermal toxicity studies using rats have been conducted for two of the FLL Samples with both indicating low toxicity with an LD50≥ 2000 mg/kg bw. In both tests, 2000 mg/kg bw was the highest dosing rate and no mortalities were observed at this dose, meaning that a NOAEL of 2000 mg/kg bw can also be inferred. The LD50 limit value does not fall below the criterion of 2000 mg/kg bw for Category 4 with respect to acute dermal toxicity classification indicating that the FLL Substances do not pose an acute toxicity hazard ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/baec9f9c-de89-4345-b8c1-544a780c16f5/documents/IUC5-15399772-3fc3-440f-a3f9-1f48615a9243_a8c8003d-c347-48e4-a87f-c50b48b19884.html,,,,,, "Oils, vegetable, sulfonated, sodium salts",97489-04-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/baec9f9c-de89-4345-b8c1-544a780c16f5/documents/IUC5-15399772-3fc3-440f-a3f9-1f48615a9243_a8c8003d-c347-48e4-a87f-c50b48b19884.html,,oral,LD50,"2,000 mg/kg bw",, "Oils, vegetable, sulfonated, sodium salts",97489-04-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/baec9f9c-de89-4345-b8c1-544a780c16f5/documents/IUC5-15399772-3fc3-440f-a3f9-1f48615a9243_a8c8003d-c347-48e4-a87f-c50b48b19884.html,,dermal,LD50,"2,000 mg/kg bw",, O-isopropyl ethylthiocarbamate,141-98-0," -NOAEL of 125 mg/kg bw/day was established based on no effects observed for Butan-1-ol (Butyl alcohol) as a main constituent of IPETC/ O-isopropyl ethylthiocarbamate. LOAEL of 500 mg/kg bw/day was established based on clinical signs of SNC depression (ataxia and hypoactivity).-NOAEC of 12.47 mg/m3 was established based on no effects in rats.- The NOAEL was 144.43 mg/kg bw per day, on the basis of decreased body weight, body-weight gain, food consumption, and number of lymphocytes and increased bilirubin ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da1b8b24-ebc8-4935-889f-b0d600b7f1bd/documents/IUC5-215fe222-6eb5-4d5c-ac56-fbb6d1c510be_aa651218-4542-496f-831a-0d9514f51ec7.html,,,,,, O-isopropyl ethylthiocarbamate,141-98-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da1b8b24-ebc8-4935-889f-b0d600b7f1bd/documents/IUC5-215fe222-6eb5-4d5c-ac56-fbb6d1c510be_aa651218-4542-496f-831a-0d9514f51ec7.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,144.43 mg/kg bw/day,,rabbit O-isopropyl ethylthiocarbamate,141-98-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da1b8b24-ebc8-4935-889f-b0d600b7f1bd/documents/IUC5-215fe222-6eb5-4d5c-ac56-fbb6d1c510be_aa651218-4542-496f-831a-0d9514f51ec7.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,12.47 mg/m3,,rat O-isopropyl ethylthiocarbamate,141-98-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da1b8b24-ebc8-4935-889f-b0d600b7f1bd/documents/IUC5-215fe222-6eb5-4d5c-ac56-fbb6d1c510be_aa651218-4542-496f-831a-0d9514f51ec7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat O-isopropyl ethylthiocarbamate,141-98-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da1b8b24-ebc8-4935-889f-b0d600b7f1bd/documents/IUC5-215fe222-6eb5-4d5c-ac56-fbb6d1c510be_aa651218-4542-496f-831a-0d9514f51ec7.html,Repeated dose toxicity – local effects,dermal,NOAEL,2.73 mg/cm2,no adverse effect observed,rabbit O-isopropyl ethylthiocarbamate,141-98-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da1b8b24-ebc8-4935-889f-b0d600b7f1bd/documents/IUC5-215fe222-6eb5-4d5c-ac56-fbb6d1c510be_aa651218-4542-496f-831a-0d9514f51ec7.html,Repeated dose toxicity – local effects,inhalation,NOAEC,12.47 mg/m3,no adverse effect observed,rat O-isopropyl ethylthiocarbamate,141-98-0," -Acute oral toxicity:The LD50 value of 2324 mg/kg in rats were determined for Isopropyl Ethyl Thionocarbamate (IPETC) .This show that IPETC/O-isopropyl ethylthiocarbamate is of a slightly order of acute oral toxicity .   -Acute Dermal Toxicity:In an acute dermal toxicity study with Isopropyl Ethyl Thionocarbamate (IPETC) in rabbits, performed to OECD 402 test guideline, an LD50 >2000 mg/kg bw was determined. This show that IPETC/O-isopropyl ethylthiocarbamate is not toxic foracute Dermal toxicity .   -Acute inhalation toxicity:Based on the study of Gill MW, Burleigh-Flayer HD, Strother DE, Masten LW, McKee RH, Tyler TR, Gardiner TH.1995, exposure of male and female rats to isopropanol the LC50 was > 10000 ppm.Concentrations of 10000 ppm is equal to 24.95 mg/m³ (molecular mass of 60.10 g/mol  for Propan-2-ol) Propan-2-ol (Isopropyl alcohol) is both reagents used in the manufacture of IPETC/O-isopropyl ethylthiocarbamate. Therefore, Propan-2-ol (Isopropyl alcohol) need to be considered in the assessment of IPETC/O-isopropyl ethylthiocarbamate.   It is concluded that the substance IPETC/O-isopropyl ethylthiocarbamate meet the criteria to be classified for human health hazards for acute oral effects.  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da1b8b24-ebc8-4935-889f-b0d600b7f1bd/documents/IUC5-361b6097-03cf-4f25-b72b-30f300e2de8c_aa651218-4542-496f-831a-0d9514f51ec7.html,,,,,, O-isopropyl ethylthiocarbamate,141-98-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da1b8b24-ebc8-4935-889f-b0d600b7f1bd/documents/IUC5-361b6097-03cf-4f25-b72b-30f300e2de8c_aa651218-4542-496f-831a-0d9514f51ec7.html,,oral,LD50,"2,324 mg/kg bw",adverse effect observed, O-isopropyl ethylthiocarbamate,141-98-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da1b8b24-ebc8-4935-889f-b0d600b7f1bd/documents/IUC5-361b6097-03cf-4f25-b72b-30f300e2de8c_aa651218-4542-496f-831a-0d9514f51ec7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, O-isopropyl ethylthiocarbamate,141-98-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da1b8b24-ebc8-4935-889f-b0d600b7f1bd/documents/IUC5-361b6097-03cf-4f25-b72b-30f300e2de8c_aa651218-4542-496f-831a-0d9514f51ec7.html,,inhalation,LC50,24.95 mg/m3,no adverse effect observed, "Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)",34140-91-5,"A 28-day study on Oleyl-diamine dioleate resulted to a NOAEL of 5 mg/kg bw/day is available.  A read-across to diamines category is applied taking into account a 28-day study with Oleyl-diamine (NOAEL of 1.25 mg/kg bw/day) and a 90-day study with N-C12-14-diamine( NOAEL of 0.4 mg/kg bw/day equivalent to 1.1 mg Oleyl-diamine dioleate/kg bw/day). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): High quality studies, showing consistent results and justifying the cross-reading from the group of diamines for the use of a 90-day study (OECD 408) to cover Annex IX requirements. Studies are GLP compliant with Klimisch score 1. The applied read-across is adequate and likely to result to an overestimation of toxicity as testing is performed on the most toxic member of the diamine category. The NOAEL is based on cross-reading from 0.4 mg/kg of C12-14-diamine as NOAEL value for Oleyl-diamine, which then is converted to the corresponding value for the dioleate salt of Oleyl-diamine. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5c6022d-1abb-4a8f-be2a-f9f856c82fb6/documents/28c0c22c-aae3-4d68-9ced-3257448b495e_88f01419-b2f2-4270-9974-9de91a4db738.html,,,,,, "Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)",34140-91-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5c6022d-1abb-4a8f-be2a-f9f856c82fb6/documents/28c0c22c-aae3-4d68-9ced-3257448b495e_88f01419-b2f2-4270-9974-9de91a4db738.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,1 mg/kg bw/day,,rat "Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)",34140-91-5,"There are two acute oral studies available indicating an oral LD50 > 2000 mg/kg bw, and one acute dermal study resulting to an LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5c6022d-1abb-4a8f-be2a-f9f856c82fb6/documents/df5004cf-1408-4ec4-9db1-6c723650c0cd_88f01419-b2f2-4270-9974-9de91a4db738.html,,,,,, "Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)",34140-91-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5c6022d-1abb-4a8f-be2a-f9f856c82fb6/documents/df5004cf-1408-4ec4-9db1-6c723650c0cd_88f01419-b2f2-4270-9974-9de91a4db738.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "Oleic acid, compound with (Z)-N-octadec-9-enylpropane-1,3-diamine (2:1)",34140-91-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5c6022d-1abb-4a8f-be2a-f9f856c82fb6/documents/df5004cf-1408-4ec4-9db1-6c723650c0cd_88f01419-b2f2-4270-9974-9de91a4db738.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "Oleic acid, compound with 2-amino-2-methylpropan-1-ol (1:1)",68140-41-0," Acute Toxicity: Oral - The LD50 is > 2000 mg/kg body weight based on an OECD testguideline 420 compliant study, conducted under GLP conditions. Acute Toxicity Dermal - This study is not required as the oral LD50 is > 2000 mg/kg body Acute Toxicity Inhalaltion - This study is not required at the registered tonnage band. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d384166-2512-4022-914c-2b22540b502a/documents/c948fc2b-ddac-44c4-9e2b-66102d4a7281_55648493-5db7-4d0c-9030-2b6855e8d909.html,,,,,, "Oleic acid, copper salt",10402-16-1,"ORAL : The pivotal repeat dose study was a 90-day study by the oral route with copper sulphate pentahydrate. In rats and mice, ingestion of copper sulphate pentahydrate produced forestomach lesions that could be to the irritant effects of the compound. The NOAEL for this effect was 16.7 mg Cu/kg bw/day in rats and 97 and 126 mg Cu/kg bw/day in male and female mice respectively. In rats inflammation of the liver was observed. The NOAEL’s for liver and kidney damage were 16.7 mg Cu/kg bw/day in rats. This is the pivotal study and the NOAEL of 16.7 mg Cu/kg bw/day will be used in the risk characterisation. INHALATION : the pivotal study in the 28 days rat inhalation study on Cu2O. The main conclusion is observed effects at all doses (0.2-2 mg/m3) but no adverse effects at the highest dose tested (2 mg/m3). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d84ab4cb-8196-4748-a39f-e16e7ac7f145/documents/840c372e-ff31-4d4c-9d70-cf2b911ac2bc_98ee413c-cd0d-4ca8-9a94-7d860c87d1ef.html,,,,,, "Oleic acid, copper salt",10402-16-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d84ab4cb-8196-4748-a39f-e16e7ac7f145/documents/840c372e-ff31-4d4c-9d70-cf2b911ac2bc_98ee413c-cd0d-4ca8-9a94-7d860c87d1ef.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,>= 1.6 mg/m3,,rat "Oleic acid, copper salt",10402-16-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d84ab4cb-8196-4748-a39f-e16e7ac7f145/documents/840c372e-ff31-4d4c-9d70-cf2b911ac2bc_98ee413c-cd0d-4ca8-9a94-7d860c87d1ef.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16.7 mg/kg bw/day,,rat "Oleic acid, copper salt",10402-16-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d84ab4cb-8196-4748-a39f-e16e7ac7f145/documents/840c372e-ff31-4d4c-9d70-cf2b911ac2bc_98ee413c-cd0d-4ca8-9a94-7d860c87d1ef.html,Repeated dose toxicity – local effects,inhalation,NOAEC,>= 1.6 mg/m3,no adverse effect observed,rat "Oleic acid, copper salt",10402-16-1,"The experimentally measured oral LD50 for oleic acid, copper salt is >2000 mg/kg bw, hence the substance is not to be classified according to regulation (EC) 1272/2008 for acute oral toxicity as well as for specific target organ toxicity, single exposure (STOT SE). No acute dermal toxicity studies with oleic acid, copper salt are available, thus the acute toxicity will be addressed with existing data on the dissociation products copper and oleic acid. Signs of acute dermal toxicity are not expected for oleic acid, copper salt, since the LD50 for both constituents copper and oleic acid, is above 2000 mg/kg bw. Based on the above given information oleic acid, copper salt is not expected to show any acute toxic effects via dermal route and does not require a classification for acute dermal toxicity (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d84ab4cb-8196-4748-a39f-e16e7ac7f145/documents/2c153270-a66a-4897-bb2b-a922acfefc90_98ee413c-cd0d-4ca8-9a94-7d860c87d1ef.html,,,,,, "Oleic acid, copper salt",10402-16-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d84ab4cb-8196-4748-a39f-e16e7ac7f145/documents/2c153270-a66a-4897-bb2b-a922acfefc90_98ee413c-cd0d-4ca8-9a94-7d860c87d1ef.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Oleonitrile,112-91-4,NOAEL = 50 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fa78af5-33f5-4da6-9d7c-22fd3c810224/documents/5f7b4a35-0c11-4884-b0fb-f100b88dc8b5_3cf7d767-cda1-4376-bfbf-d978fd5f468e.html,,,,,, Oleonitrile,112-91-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8fa78af5-33f5-4da6-9d7c-22fd3c810224/documents/5f7b4a35-0c11-4884-b0fb-f100b88dc8b5_3cf7d767-cda1-4376-bfbf-d978fd5f468e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Oleonitrile,112-91-4,"Acute toxicity: Oral LD50 > 5,000 mg/kg for rat (LD50 limit test - no mortality)   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fa78af5-33f5-4da6-9d7c-22fd3c810224/documents/46262876-052c-45b1-abf0-e252e55bda5c_3cf7d767-cda1-4376-bfbf-d978fd5f468e.html,,,,,, Oleonitrile,112-91-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fa78af5-33f5-4da6-9d7c-22fd3c810224/documents/46262876-052c-45b1-abf0-e252e55bda5c_3cf7d767-cda1-4376-bfbf-d978fd5f468e.html,,oral,LD0,"> 5,000 mg/kg bw",no adverse effect observed, oligomeric Reaction products from Hydrogenation and Hydrolysation of Starch,738602-93-2,two Guideline studies available ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/412f25e5-2462-4562-a8a3-5a048fd33b19/documents/d1502a00-90da-4402-a910-7b1336571e61_76aa9ac7-e858-4101-9a62-43122eaa7416.html,,,,,, oligomeric Reaction products from Hydrogenation and Hydrolysation of Starch,738602-93-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/412f25e5-2462-4562-a8a3-5a048fd33b19/documents/d1502a00-90da-4402-a910-7b1336571e61_76aa9ac7-e858-4101-9a62-43122eaa7416.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, oligomeric Reaction products from Hydrogenation and Hydrolysation of Starch,738602-93-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/412f25e5-2462-4562-a8a3-5a048fd33b19/documents/d1502a00-90da-4402-a910-7b1336571e61_76aa9ac7-e858-4101-9a62-43122eaa7416.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Olivine, cobalt silicate blue",68187-40-6,"No repeated dose toxicity study with Olivine, cobalt silicate blue is available, thus the repeated dose toxicity will be addressed with existing data on the relevant toxic unit cobalt. The source information is selected based on the read-across approach implemented by the Cobalt REACH consortium for inhalation local effects and oral systemic effects, respectively. Further details on the read-across approach are given in the report attached to IUCLID section 13. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d55310c-d887-459e-813d-98ce19c41192/documents/67813bb8-9aa0-490b-9bd8-397f32181938_6f1952b3-3d64-4122-8db3-38440d3b8064.html,,,,,, "Olivine, cobalt silicate blue",68187-40-6," For the oral and inhalation route, reliable OECD guideline conform study reports are available. One study report (Leuschner 2020; OECD 423 (2001); GLP compliant) for the oral route states a LD50 value > 2000 mg/kg bw. Haferkorn (2018; OECD 436 (2009); GLP compliant) determined a LC50 value for the inhalation route of 0.75 mg/L air (actual concentration). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d55310c-d887-459e-813d-98ce19c41192/documents/ec7855d0-99da-470f-af15-f7ff4f08399e_6f1952b3-3d64-4122-8db3-38440d3b8064.html,,,,,, "Olivine, cobalt silicate blue",68187-40-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d55310c-d887-459e-813d-98ce19c41192/documents/ec7855d0-99da-470f-af15-f7ff4f08399e_6f1952b3-3d64-4122-8db3-38440d3b8064.html,,inhalation,LC50,0.75 mg/m3,adverse effect observed, OO-tert-butyl monoperoxymaleate,1931-62-0,"The target substance OO-tert-butyl monoperoxymaleate was tested in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422). Dose groups chosen were based on the results of a 14-day dose range finding study. No adverse effects were found after oral administration of the test item in male and female rats. Based on the results, the NOAEL is considered to be 160 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c1971b4-ab7a-488d-bc89-dcacee622695/documents/1fd14759-b41b-4d20-b183-2f61568804a2_d11ce4b4-392f-452e-824b-a45c1b04256e.html,,,,,, OO-tert-butyl monoperoxymaleate,1931-62-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c1971b4-ab7a-488d-bc89-dcacee622695/documents/1fd14759-b41b-4d20-b183-2f61568804a2_d11ce4b4-392f-452e-824b-a45c1b04256e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,160 mg/kg bw/day,,rat OO-tert-butyl monoperoxymaleate,1931-62-0,"For OO-tert-butyl monoperoxymaleate (target substance) data is available to assess the acute toxicity of two routes. In an acute oral toxicity study conducted according to OECD 401, Wistar rats (5/sex/dose) were given a single oral dose of OO-tert-butyl monoperoxymaleate (> 97% purity), suspended in a 1% aqueous carboxymethyl cellulose, at a dose of 200, 1000, 2000 and 5000 mg/kg bw. The animals were observed for 15 days. Due to the mortality distribution, oral LD50 values of 449 mg/kg (males), 234 mg/kg (females), and 252 mg/kg bw for both sexes could be obtained. In an acute dermal toxicity study similar to OECD 402, groups of young adult male and female Sprague-Dawley rats (5/sex) were dermally exposed to OO-tert-butyl monoperoxymaleate for 24 hours to 10% of body surface area at a dose of 2000 mg/kg bw. Animals then were observed for 14 days. Under the conditions of this test, the acute dermal LD50 of OO-tert-butyl monoperoxymaleate was estimated to be greater than 2000 mg/kg bw in the rat.  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c1971b4-ab7a-488d-bc89-dcacee622695/documents/ea0da566-2a24-45df-bacf-be48c75cd218_d11ce4b4-392f-452e-824b-a45c1b04256e.html,,,,,, OO-tert-butyl monoperoxymaleate,1931-62-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c1971b4-ab7a-488d-bc89-dcacee622695/documents/ea0da566-2a24-45df-bacf-be48c75cd218_d11ce4b4-392f-452e-824b-a45c1b04256e.html,,oral,LD50,252 mg/kg bw,adverse effect observed, OO-tert-butyl O-(2-ethylhexyl) peroxycarbonate,34443-12-4," OECD 408 study The potential toxicity of Luperox TBEC was evaluated following daily oral administration (gavage) to rats for 13 weeks (Papineau, 2018). On completion of the treatment period, designated animals were held for a 6-week treatment-free period in order to evaluate the reversibility of any findings. This GLP study was carried out according to OECD test guideline No. 408 (21 September 1998). One group of 15 males and 15 females Sprague-Dawley rats was treated daily by the oral route (gavage) with the test item, at the dose level of 600 mg/kg/day (group 4) for 13 weeks. Two other groups of 10 males and 10 females were treated with the test item at the dose level of 100 or 300 mg/kg/day (groups 2 and 3, respectively). One control group of 15 males and 15 females received the vehicle only (corn oil) under the same experimental conditions, and acted as a control group (group 1). A constant dosage volume of 5 mL/kg/day was used.At the end of the treatment period, the animals were euthanized, except for the first five group 1 and 4 animals per sex, which were kept for a 6-week treatment-free period. The actual test item concentrations in the dose formulations prepared for use in Weeks 1, 4, 8 and 13 were determined using a High Performance Liquid Chromatography with tandem Mass Spectrometry detection method (LC/MS-MS). The animals were checked at least once daily for mortality and clinical signs. Detailed clinical examinations were performed weekly and a Functional Observation Battery (FOB) was conducted in Week 12. Body weight was recorded pre-test, on the first day of treatment and then once a week. Food consumption was recorded weekly. Ophthalmological examinations were performed on all animals before the beginning of the treatment period and on control and high-dose animals at the end of the treatment period (Week 13). Hematology, blood biochemistry and urinary investigations were performed on all animals euthanized at the end of the treatment period (Week 13). Hematology (females) and blood biochemistry (both sexes) were also determined at the end of treatment-free period (Week 20). Additional blood samples were collected in Weeks 13 and 20 for possible analysis of thyroid hormone levels. The estrous cycle was determined over 21 or 14 consecutive days for all females at the end of the treatment or treatment-free period, respectively. At the end of the treatment period, seminological investigations (count and motility) were performed on all males, and sperm morphology was determined in control and high-dose males. On completion of the treatment or treatment-free period, the animals were euthanized and a full macroscopicpost-mortemexamination was performed. Designated organs were weighed and selected tissues were preserved. A microscopic examination (including a detailed examination of the testes) was performed on designated tissues from control and high-dose animals euthanized at the end of the treatment period and from animals that were euthanized prematurely, and on all macroscopic lesions from low- and intermediate-dose animals (groups 2 and 3) euthanized on completion of the treatment period. A microscopic examination was also performed on kidney slides (immunostained with an antibody for a2u-globulin protein) from all control and high-dose males euthanized at the end of the treatment period. The stomach with forestomach (both sexes), kidneys (males) and vagina (females) were also microscopically examined for low- and intermediate-dose animals (groups 2 and 3) euthanized at the end of the treatment period, and for the recovery animals (groups 1 and 4) as changes were noted in these organs at the end of the treatment period. Actual concentrations of the test item in the dose formulations administered to the animals during the study remained within an acceptable range (-6.3% to +8.9%) compared to the nominal concentrations. There were no test item-related unscheduled deaths in any group. Ptyalism was observed in controls and at all dose levels with a dose-related incidence. This sign was considered to be non-adverse The FOB results were unaffected by the test item treatment. Lower body weight gain was recorded throughout the treatment period in males given 600 mg/kg/day (-10%vs.controls) leading to a minimally lower body weight on completion of the treatment period (-8% vs. controls). As these differences were of low magnitude, not associated with any other relevant findings and reversible at the end of the treatment-free period, they were considered to be non-adverse. Food consumption was not affected by the test item treatment. No ophthalmological findings were observed at the end of the treatment period. A non-adverse slight increase in the length of diestrus was observed in females given 600 mg/kg/day at the end of the treatment period. No variations were observed at the end of the treatment-free period. The epididymal sperm motility and morphology, and the testicular and epididymal spermatozoa count were unaffected by the test item treatment. At hematology and blood biochemistry investigations, all changes were considered to be of no toxicological importance. At urinary investigations, no test item-related effects were observed at the end of the treatment period. At pathology investigations, the alpha 2u-globulin nephropathy observed in male rats at all dose levels was considered adverse from 300 mg/kg/day, but specific to male rats and irrelevant for human risk assessment. In addition, there was non-adverse acanthosis/hyperkeratosis in the forestomach (both sexes, all doses), possibly related to a local irritant effect of the test item, and vaginal mucification in a few high-dose females which was considered possibly test item-related but non-adverse effect. At the end of the 6-week treatment-free period, full recovery was observed for vaginal mucification, and ongoing recovery was observed for the alpha 2u-globulin nephropathy in males and for acanthosis/hyperkeratosis of the stomach.  The toxicity of Luperox TBEC was evaluated after daily oral administration (gavage) to Sprague-Dawley rats at dose levels of 100, 300 or 600 mg/kg/day for 13 weeks followed by a 6-week treatment-free period. Under the experimental conditions of the study, from the dose level of 300 mg/kg/day, adverse test item-related effects were observed in the kidneys of male rats: a2u-globulin accumulation (as confirmed by immunohistochemistry). This is considered to be a rat specific effect with no relevance for human risk assessment. No other adverse effects were observed in the study. Consequently, the NOAEL (No Observed Adverse Effect Level) was established at 600 mg/kg/day in females and males if we exclude the adverse lesions seen in male kidneys (a2u-globulin protein nephropathy-related findings) which are specific to male rats and have no relevance for human risk assessment. OECD 407 study The potential toxicity of TBEC was evaluated in a repeated dose study performed following to OECD Guideline 407 (July 27th1995) (Cerven, 1999). TBEC was administered once daily by gavage to Sprague-Dawley rats (5 Males and 5 Females), at the dose-levels of 0, 150, 550 and 1000 mg/kg/d during 28 days (but animals were not dosed the 20 th day). Body weights were recorded pretest, weekly, at death and at termination in the survivors. The animals were observed once daily for toxicity and pharmacological effects and twice daily for morbidity and mortality. Food consumption was calculated weekly. A Functional Observational Battery examination, designed to assess specific neurotoxicity and behavioral changes, was conducted on days 23 and 26. On day 29, all surviving animals were anesthetized with ether and exsanguinated. Whole blood, plasma and serum were analyzed for selected hematology and clinical chemistry parameters. All animals were examined for gross pathology. All the tissues were preserved in 10% Neutral Buffered Formalin. Two females dosed at 550 mg/kg and two females dosed at 1000 mg/kg died during the study. Pathological examination revealed abnormalities consistent with inadvertent gavage accidents and were not attributed to any toxic effect of the test article. Instances of abnormal systemic signs were minimal. There were no significant differences in mean body weights, food consumption, functional observational battery parameters, and organ weights. Instances of significantly different mean hematology, clinical chemistry and organ/body weight ratios were noted, but there was no evidence of dose-response effects and these instances are not considered biologically significant. Only the mean blood albumin was significantly less in the control group than in mid and high dose group. This was considered biologically unremarkable, since there were no related findings in any other liver or kidney enzymes nor any histological changes. Necropsy results of surviving animals were generally normal. Microscopic examination revealed no treatment related microscopic changes in any of the animals dosed at 150 mg/kg/day. Treatment-related changes were observed in kidneys of male rats in the high and mid dose groups and in the stomach of male and female rats in the high and mid dose groups. The incidence and severity of the treatment-related changes occurred in a dose-related manner. The kidney pathology noted in the male rats was not considered to be relevant to human exposure since the enzyme system responsible for the hyaline droplet formation are unique to the male rat. In conclusion, the 28 day repeated oral administration (27 doses) of Luperox TBEC in rats produced no clinical effects but did produce microscopic changes at doses of 550 and 1000 mg/kg/day. The observed pathologic changes were noted in the stomach of male and female rats and in the kidneys of male rats only. The pathologic changes noted in the stomach are considered to be secondary to a local irritating effect and therefore of low relevance for hazard assessment. The kidney pathology noted in the male rats is not considered to be relevant to human exposure since the enzyme system responsible for the hyaline droplet formation are unique to the male rat. Therefore, the no observed effect level (NOEL) was estimated to be 150 mg/kg bw/day based on forestomach effects. In addition, the systemic NOAEL can be estimated at 1000 mg/kg bw/day in male and female rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5020bc2b-370e-4c56-a8d7-340808597117/documents/caf0913f-f8c9-4be4-a8c4-94c427b33921_0ec7e034-689b-49eb-9ed2-52acdbf8b1fb.html,,,,,, OO-tert-butyl O-(2-ethylhexyl) peroxycarbonate,34443-12-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5020bc2b-370e-4c56-a8d7-340808597117/documents/caf0913f-f8c9-4be4-a8c4-94c427b33921_0ec7e034-689b-49eb-9ed2-52acdbf8b1fb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat OO-tert-butyl O-(2-ethylhexyl) peroxycarbonate,34443-12-4,"Acute oral toxicity The Acute oral toxicity of TBEC was evaluated in rats according to OECD N°401 guideline (Acute Toxic Standard Method). Groups of 5 male and 5 female Sprague Dawley rats were given a single oral dose of 5000 mg/kg (Thouin, 1985). Following treatment, rats were observed daily and weighted weekly. A gross necropsy examination was performed at the time of scheduled euthanasia (Day 14). There was no mortality. Excepted diarrhea among most animals in the beginning of the study, no systemic toxicity was reported Body weight gain was normal. Macroscopic examination at necropsy revealed no gross abnormalities. Under these experimental conditions, the oral LD0 of TBEC was higher than 5000 mg/kg in Sprague Dawley rats.   TBEC evaluated for acute oral toxicity in male and female white Sprague-Dawley rats in a limit test similar to OECD 401 guideline (Reagan, 1985a). TBEC was administered by gavage to each of ten Sprague-Dawley rats (5 male, 5 female) at a level of 5.0 g/kg body weight. All animals survived the 15 day post-treatment observation period. Based on this result, the acute oral LD0 of TBEC was higher than 5.0 g/kg body weight.   Acute dermal toxicity TBEC was evaluated for acute dermal toxicity in male and female white rabbits in a limit test similar to OECD 402 guideline (Reagan, 1985b). TBEC was applied to each of ten rabbits at a level of 2.0 g/kg body weight. There was noteworthy findings at necropsy. All animals survived the 15 day post-application observation period. Based on this result, the acute dermal LD0 of TBEC was higher than 2.0 g/kg body weight. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 1, GLP compliant. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch 2, GLP compliant. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5020bc2b-370e-4c56-a8d7-340808597117/documents/7135a275-d378-4f95-a0b5-b58285cb1427_0ec7e034-689b-49eb-9ed2-52acdbf8b1fb.html,,,,,, OO-tert-butyl O-(2-ethylhexyl) peroxycarbonate,34443-12-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5020bc2b-370e-4c56-a8d7-340808597117/documents/7135a275-d378-4f95-a0b5-b58285cb1427_0ec7e034-689b-49eb-9ed2-52acdbf8b1fb.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, OO-tert-butyl O-(2-ethylhexyl) peroxycarbonate,34443-12-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5020bc2b-370e-4c56-a8d7-340808597117/documents/7135a275-d378-4f95-a0b5-b58285cb1427_0ec7e034-689b-49eb-9ed2-52acdbf8b1fb.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Orange lead,1314-41-6," Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/21fe35ca-8f5f-4b71-9253-9dcaa3fa8f3f/documents/55240df1-e7fa-4fe8-8269-766f9e1416fc_8f854036-e8af-4fd6-98a2-d61a0478ae43.html,,,,,, Orange lead,1314-41-6, Inorganic lead compounds do not exhibit toxicity in acute toxicity tests with experimental animals. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21fe35ca-8f5f-4b71-9253-9dcaa3fa8f3f/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_8f854036-e8af-4fd6-98a2-d61a0478ae43.html,,,,,, Orange lead,1314-41-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21fe35ca-8f5f-4b71-9253-9dcaa3fa8f3f/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_8f854036-e8af-4fd6-98a2-d61a0478ae43.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Orange lead,1314-41-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21fe35ca-8f5f-4b71-9253-9dcaa3fa8f3f/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_8f854036-e8af-4fd6-98a2-d61a0478ae43.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Orange lead,1314-41-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/21fe35ca-8f5f-4b71-9253-9dcaa3fa8f3f/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_8f854036-e8af-4fd6-98a2-d61a0478ae43.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Orthoboric acid, compound with 2,2',2''-nitrilotriethanol",10049-36-2, Acute Toxicity: Oral -LD50 > 2000 mg/kg bodweight in female rats Acute Toxicity: Dermal -Study not required according Annex VII standard information reequirements for substances manufactured or imported in quantities of one tonne or more if the oral LD50 is > 2000 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/59a9b7cd-e402-4a25-bb4d-e86262b86c08/documents/20646777-6930-41ee-94c4-449ca0391d93_cf2fcda1-c7b4-4dd4-90d7-faeca25c3946.html,,,,,, Orthoperiodic acid,10450-60-9," 90-Day Study (read-across; Guo et al., 2005) Under the conditions of the study KIO3 was found to result in lower thyroxine in serum, lipid metabolism disorder and retina dysfunction in rats. The NOAEL of KIO3 in rats was determined to be 3000 μg/L. Serum TC level was found to be a sensitive contacting biomarker of excessive iodine. Repeat Dose, Reproductive and Developmental Toxicity Screening (read-across; Vorhees et al., 1984) Under the conditions of the study, dietary doses of up to 0.1 % w/w test material in the diet, equivalent to approximately 90 mg/kg/day, produced only minor effects on parental weight gain and food consumption, and no significant effects on parental mortality. The NOAEL for parental toxicity was therefore determined to be 90 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8e0e9f8-f0fc-47b3-a7f4-f700fa64288d/documents/8847c642-f2e9-4efc-aee8-8ab0bc810071_86398810-20a8-4f73-a20a-fd64f21f1ff3.html,,,,,, Orthoperiodic acid,10450-60-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8e0e9f8-f0fc-47b3-a7f4-f700fa64288d/documents/8847c642-f2e9-4efc-aee8-8ab0bc810071_86398810-20a8-4f73-a20a-fd64f21f1ff3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,90 mg/kg bw/day,,rat Orthoperiodic acid,10450-60-9, The test material has a low pH and in the interest of animal welfare the acute toxicity studies are therefore waived. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8e0e9f8-f0fc-47b3-a7f4-f700fa64288d/documents/f0e5f528-0adf-45c4-b903-fde0c2010982_86398810-20a8-4f73-a20a-fd64f21f1ff3.html,,,,,, Osalmid,526-18-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e969a6ab-c7cd-4e2a-812f-bbc81835b89a/documents/68d32452-9b1c-485f-9761-eeb7b75f2164_4781472d-bccb-4611-9179-8c4408b71994.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Oxalonitrile,460-19-5,Oral exposure is not possible due to physicochemical properties of ethanedinitrile. Dermal exposure- no adverse effect observed Inhalation exposure - according CLP - Acute tox. 2; H220 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fc3cd05-24e6-430b-8950-f6025c6ae795/documents/d66ec871-196b-443e-9b92-7ecee29ed209_3d126452-b4dc-4482-b1a2-e8af0a0b2215.html,,,,,, Oxalonitrile,460-19-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5fc3cd05-24e6-430b-8950-f6025c6ae795/documents/d66ec871-196b-443e-9b92-7ecee29ed209_3d126452-b4dc-4482-b1a2-e8af0a0b2215.html,,inhalation,LC50,>=136.46 ,adverse effect observed, "Oxazolidine, diheptyl~",913171-06-9," After having registered Sa 34 for the tonnage band 1 – 10 t/a, we now want to increase the production volume and therefore want to register Sa 34 for the tonnage band 10 – 100 t/a. Since products incorporating Sa 34 are intended to have direct contact with end consumers, prior to initiating any new test we have defined potential genotoxic properties as knock-out criterion. In case of genotoxic properties, we would stop using the material and consequentially cease the registration which would not affect any other registrant since Sa 34 is proprietary to Henkel. In this case, there would be no need any more to generate more data in order to support such a registration. From our perspective this approach is the best solution from an economical as well as from an animal welfare point of view. In that respect, we have developed a testing strategy for obtaining the toxicological data required for the 10 – 100 t/a tonnage band. This testing strategy applies a tiered approach starting with the two required in vitro genotoxicity assays – gene mutation and chromosome aberration in mammalian cells (according to REACH Annex VIII). As described in this dossier, Sa 34 is considered to be clastogenic in the in vitro chromosome aberration test (OECD TG 473). In order to clarify if the in vitro genotoxicity results are relevant in vivo, the next step is to perform an in vivo genotoxicity testing as outlined in REACH Annex IX. Therefore, a testing proposal for an in vivo mammalian erythrocyte micronucleus test (OECD TG 474) was included in this dossier. Any other test required according to REACH Annex VIII will only be initiated if genotoxicity is finally clarified. Toxicological data other than the mentioned in vitro genotoxicity results required for the tonnage band of 10 - 100 t/a are therefore not yet available but will be generated and provided as soon as possible. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd7c9600-7c3c-466a-9956-58aaa04a1618/documents/06b67023-c2bc-4174-8fa2-70a358dda07f_ff97e859-882b-4ca1-8875-431b097880ee.html,,,,,, "Oxazolidine, diheptyl~",913171-06-9, REACH_LD50 >2000 mg/kg | rat (male/female) | OECD 423 | #key study# ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd7c9600-7c3c-466a-9956-58aaa04a1618/documents/15f47d1c-368c-4eb3-bed2-8b58d5cce3fb_ff97e859-882b-4ca1-8875-431b097880ee.html,,,,,, "Oxazolidine, diheptyl~",913171-06-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd7c9600-7c3c-466a-9956-58aaa04a1618/documents/15f47d1c-368c-4eb3-bed2-8b58d5cce3fb_ff97e859-882b-4ca1-8875-431b097880ee.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Oxidase, monoamine",9001-66-5,"In general, enzymes are of very low toxicity due to ready biodegradability and very low bioavailability. Data from acute and sub-chronic oral toxicity studies provide evidence that enzymes are of very low toxicological activity (1). Additionally, CDX-616 has not been engineered for gastric stability (low pH and gastric media) and would be digested/hydrolyzed when ingested. Like all proteins, enzymes that have not been engineered for low pH and/or gastric stability, will denature or degrade into amino acids.   The two 14-day oral toxicity studies of CDX-6114 in both rats and cynomolgus monkeys showed no drug-related signs of toxicity; therefore, the NOAEL was considered to be at least 720 mg/kg bw/day in both species (2).   CDX-7108 is a lipase enzyme developed using the same engineering work structure with manufacturing based on the same manufacturing platform as CDX-616 (aka monoamine oxidase). In rats and monkeys administered CDX 7108 for 28 days at doses ≤ 369 mg/kg bw/day, there were no CDX-7108 related macroscopic or microscopic findings at the end-of-dosing on Day 28 or in animals held for a 2 week treatment-free recovery period (3). Based on the weight of evidence presented, further live animal testing to investigate the sub-chronic oral toxicity of monoamine oxidase (aka CDX-616) is scientifically unnecessary as there is sufficient information for deriving an adequate qualitative hazard assessment.   (1) Enzymes REACH Consortium (2010). Data waiving argumentation for technical enzymes. (2) Study numbers 0440RC130.001, 0437RC130.001, 0440SC130.002 and 0437RC130.001 (3) Study numbers CDX1783-R-2005, CDX1783-R-2021, CDX1783-NHP-2006 and CDX1783-NHP-2022 (4) Setini, A., Pierucci, F., Senatori, O. and Nicotra, A., 2005. Molecular characterization of monoamine oxidase in zebrafish (Danio rerio). Comparative Biochemistry and Physiology Part B: Biochemistry and Molecular Biology, 140(1), pp.153-161. doi: 10.1016/j.cbpc.2004.10.002. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): High quality ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/94ea06d7-bae2-4386-9f49-4f95d6c007ca/documents/7f227d93-ce21-4a53-a743-26ea97750835_b95f8777-89ed-4e59-92eb-ee29b601188e.html,,,,,, "Oxidase, monoamine",9001-66-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/94ea06d7-bae2-4386-9f49-4f95d6c007ca/documents/7f227d93-ce21-4a53-a743-26ea97750835_b95f8777-89ed-4e59-92eb-ee29b601188e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,720 mg/kg bw/day,,rat "Oxidase, monoamine",9001-66-5,"CDX-616 has not been engineered for gastric stability and would be digested/hydrolyzed when ingested. Like all proteins, enzymes that have not been engineered for low pH and/or gastric stability, will denature or degrade into amino acids. Further live animal testing to investigate the acute oral toxicity of monoamine oxidase (aka CDX-616) is scientifically unnecessary as there is sufficient information for deriving an adequate qualitative hazard assessment. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94ea06d7-bae2-4386-9f49-4f95d6c007ca/documents/32d68726-2481-412d-9a07-22058d03ba38_b95f8777-89ed-4e59-92eb-ee29b601188e.html,,,,,, "Reaction products of ethane-1,2-diol and 2-ethyloxirane",897381-19-0,The acute oral median lethal dose (LD50) of the Precursor PD 206 in the female SD rats was estimated to be > 2000 mg/kg bw according to OECD guideline 425. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38740142-d660-4b97-9b73-f0ba5df29a26/documents/6b1316d5-10d9-4004-9bc3-fa836bc4dbad_45877f7c-4c2c-4ee1-8a3d-7cff5d3a8f11.html,,,,,, (2R)-2-methyloxirane,15448-47-2,"In rats and mice, repeated inhalation exposure to propylene oxide for 2 years produced chronic irritation of the nasal epithelium, with such effects being only marginal in nature at 30 ppm. However, concentrations of 100 ppm and above produced epithelial damage. In a 4 -week study in rats, small and reversible increases in nasal epithelium irritation occurred at 525 ppm propylene oxide. There is some evidence to indicate neurotoxicity in rats at a relatively high exposure level of 1,500 ppm after 7 weeks of exposure. No signs of neurotoxicity were observed in rats exposed to 300 ppm for 24 weeks.Repeated oral administration caused reduced body weight gain and gastric irritation, seen microscopically as reactive changes in the squamous epithelium of the fore stomach. No data are available on the toxicity of propylene oxide following repeated dermal exposure. The absence of significant toxic sequelae distant from the site of application following inhalation or oral administration suggests that concerns about target organ toxicity can be focused almost exclusively on tissues at the sites of initial contact. No additional classification for repeated exposure via inhalation, oral or dermal exposure is warranted. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d09f73af-84f0-4fab-920d-a100e2434e4a/documents/IUC5-3538201a-8236-4d70-8959-6d500bfb1c05_36cd1a82-3bef-4ce7-a9eb-ee09b9643f5e.html,,,,,, (2R)-2-methyloxirane,15448-47-2,"Propylene oxide is harmful by inhalation, oral and dermal routes of exposure. Signs of respiratory tract irritation were observed in the studies evaluated. Classification according to Annex I of Directive 67/548/EC is proposed as follows: R20/21/22 Harmful by inhalation, in contact with skin and if swallowed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d09f73af-84f0-4fab-920d-a100e2434e4a/documents/IUC5-08aebffb-43c7-424f-b59d-2f6824d25cc7_36cd1a82-3bef-4ce7-a9eb-ee09b9643f5e.html,,,,,, "Oxirane, 2-methyl-, oligomeric reaction products with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)",52624-57-4,OECD 401: LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c92ef36-097e-4521-a6cd-e6a801f256b9/documents/a70f2fa1-b098-4b2d-b27a-60c5560bd4d7_2cc4c4ea-6b5e-4861-a9bf-231d1b8bd37a.html,,,,,, "Oxirane, 2-methyl-, oligomeric reaction products with oxirane, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1)",52624-57-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c92ef36-097e-4521-a6cd-e6a801f256b9/documents/a70f2fa1-b098-4b2d-b27a-60c5560bd4d7_2cc4c4ea-6b5e-4861-a9bf-231d1b8bd37a.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Oxirane, mono[(C10-16-alkyloxy)methyl] derivs.",68081-84-5,The oral LD50 of male rats was > 27.4 and < 31.6 mL/kg bw. Therefore the mean oral LD50 of male rats was 30.1 mL/kg bw or 26800 mg/kg bw (density = 0.89g/cm3). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70b48da4-b173-475a-a06d-79f02fff740b/documents/IUC5-af878906-fd7c-42dc-9996-0e958f437cb6_2145d932-2dbc-481e-a635-e16e0d1a3387.html,,,,,, "Oxirane, mono[(C10-16-alkyloxy)methyl] derivs.",68081-84-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70b48da4-b173-475a-a06d-79f02fff740b/documents/IUC5-af878906-fd7c-42dc-9996-0e958f437cb6_2145d932-2dbc-481e-a635-e16e0d1a3387.html,,oral,LD50,"26,800 mg/kg bw",adverse effect observed, "Oxobis(pentane-2,4-dionato-O,O')titanium",14024-64-7,"L’évaluation dela toxicité aiguë de la substance à enregistrer après administration par voie orale, cutanée et par inhalation montre que l’acetylacetonate de titanyle doit être considéré comme nocif en cas d'ingestion et en cas de contact cutané mais pas par inhalation. Conformément au règlement (CE) n° 1272/2008 et ses adaptations, la classification de l’acetylacetonate de titanyle est la suivante :   Toxicité aigüe par voie orale : Catégorie 4 (Acute Tox. 4, H302 Toxicité aigüe par voie cutanée : Catégorie 4 (Acute Tox. 4, H312) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): La toxicité aigüe par voie orale de la substance à enregistrer a été évaluée suivant une approche par élément de preuve (« weight of evidence ») en considérant les données issues d’une approche par références croisées (« read-across ») pour les rats. Les données issues de l’approche par références croisées sont tirées d’études fiables (fiabilité : Klimisch 2) et qui sont suivant des méthodes pré-BPL (Bonnes Pratiques de Laboratoire : GLP) ou pré-études de référence. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Une dérogation à l'obligation d'essai pour cet effet est invoquée. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Les données issues de l’approche par analogie sont tirées d'une étude fiables (fiabilité : Klimisch 2) conduites en 1986 et qui sont donc suivant des méthodes pré-BPL (Bonnes Pratiques de Laboratoire : GLP) ou pré-études de référence ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35910176-09f3-45c9-a14c-af4fbd2e3d5d/documents/2d495243-87a3-4cc1-982c-1c71d7fb9a8d_47316342-4b9a-4751-bf95-c203d9e65d45.html,,,,,, "Oxobis(pentane-2,4-dionato-O,O')titanium",14024-64-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35910176-09f3-45c9-a14c-af4fbd2e3d5d/documents/2d495243-87a3-4cc1-982c-1c71d7fb9a8d_47316342-4b9a-4751-bf95-c203d9e65d45.html,,oral,LD50,813 mg/kg bw,adverse effect observed, "Oxobis(pentane-2,4-dionato-O,O')titanium",14024-64-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35910176-09f3-45c9-a14c-af4fbd2e3d5d/documents/2d495243-87a3-4cc1-982c-1c71d7fb9a8d_47316342-4b9a-4751-bf95-c203d9e65d45.html,,dermal,LD50,"1,278 mg/kg bw",adverse effect observed, "Oxobis(pentane-2,4-dionato-O,O')vanadium",3153-26-2," L’évaluation dela toxicité aiguë de la substance à enregistrer après administration par voie orale, cutanée et par inhalation montre que l’acétylacétonate de Vanadyle doit être considéré comme nocif en cas d'ingestion et en cas de contact cutané mais pas en cas d’inhalation. Conformément au règlement (CE) n° 1272/2008 et ses adaptations, la classification de l’acétylacétonate de Vanadyle est la suivante : Toxicité aigüe par voie orale : Catégorie 4 (Acute Tox. 4, H302 Toxicité aigüe par voie cutanée : Catégorie 4 (Acute Tox. 4, H312) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5706ee6c-b5ff-4e64-9cc2-e93f36638d65/documents/bfb67fa4-f1fe-4b90-9aa0-acbae56e81a0_818b1ecb-2d45-4f1d-bbed-32c7e0246974.html,,,,,, "Oxobis(pentane-2,4-dionato-O,O')vanadium",3153-26-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5706ee6c-b5ff-4e64-9cc2-e93f36638d65/documents/bfb67fa4-f1fe-4b90-9aa0-acbae56e81a0_818b1ecb-2d45-4f1d-bbed-32c7e0246974.html,,oral,LD50,321 mg/kg bw,adverse effect observed, "Oxobis(pentane-2,4-dionato-O,O')vanadium",3153-26-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5706ee6c-b5ff-4e64-9cc2-e93f36638d65/documents/bfb67fa4-f1fe-4b90-9aa0-acbae56e81a0_818b1ecb-2d45-4f1d-bbed-32c7e0246974.html,,dermal,LD50,"1,377 mg/kg bw",adverse effect observed, oxozirconium; silane,174633-44-4," No data are available on the repeated dose toxicity of silicon zirconium oxide. As the comparison of basic toxicological data (Annex VII endpoints) for silicon zirconium oxide and zirconium dioxide confirmed the validity of the read across assumption, i.e. that the addition of silicon to the zirconium dioxide crystal lattice does not affect the unhazardous character of zirconium dioxide, higher toxicological endpoints such as the repeated dose toxicity endpoints were covered using the approach followed in the zirconium dioxide dossier. Repeated dose toxicity: oral Two studies were used in a weight of evidence approach to cover this endpoint: - Rossiello (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test via oral route in rats with the read across substance zirconium acetate according to OECD guideline 422 (GLP). A NOAEL of >=1000 mg/kg bw/day (expressed as zirconium acetate anhydrous) was derived. No adverse effects were reported in this study. - No effects were reported after oral administration to rats during 17 weeks of zirconium basic carbonate (hydrated form) in the form of a moist paste containing 20.9% zirconium dioxide equivalent. The total intake of zirconium dioxide during the test period was 0, 0.9, 9 and 103.5 g. The equivalent NOAEL for zirconium dioxide was >= 3150-7080 mg/kg bw/day (Harrison et al., 1951). Repeated dose toxicity: inhalation No effects were reported in the study of Spiegl et al. (1956) for any of the species studied (cat, dog, guinea pig, rabbit and rat) after inhalation of zirconium dioxide dust during 30 or 60 days. The 30-day NOAEC was >= 100.8 mg ZrO2/m3 and the 60-day NOAEC was >= 15.4 mg ZrO2/m3. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f221103-b699-47bc-8ca3-d13348e8b1f8/documents/cc162234-eb3b-4a5f-ac79-fb4832da0fbc_9450592b-31a0-47bc-b15d-908ff61e85ee.html,,,,,, oxozirconium; silane,174633-44-4," Acute oral toxicity In an acute oral toxicity study with female rats (Klimisch 1, Appl, 2018), following the acute toxic class method in accordance with OECD guideline 423, the LD50 of silicon zirconium oxide was determined to be greater than 2000 mg/kg bw for female animals, observed over a period of 14 days after dosing. No mortality was observed during the test. Acute toxicity inhalation In an acute inhalation toxicity study with rats, performed according to OECD guideline 436 using the read across substance zirconium dioxide (Klimisch 1, Smith, 2010), an LC50 greater than 4.3 mg/L (actual exposure; maximum technically achievable concentration) was derived. No mortality was observed during the test. Acute dermal toxicity A key study is available for the oral and inhalation route of exposure. According to the REACH Regulation, for substances other than gases, only one additional route of exposure should be tested other than the oral route of exposure for acute toxicity (Annex VIII, Section 8.5, Column 2). Therefore, it is not necessary to perform an acute dermal toxicity study. Moreover, since the substance does not meet the criteria for classification as STOT SE by oral route and no systemic effects have been observed in the in vivo studies with dermal application (i.e. the GPMT study on skin sensitisation, Tarcai, 2018), no study is needed and the substance can be concluded not to be classified for acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f221103-b699-47bc-8ca3-d13348e8b1f8/documents/1071215b-b21b-4b1e-9acf-638387aec532_9450592b-31a0-47bc-b15d-908ff61e85ee.html,,,,,, "Oxybis(methyl-2,1-ethanediyl) diacrylate",57472-68-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): OECD TG 411 study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP compliant OECD TG 422 study ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da03531d-4267-4a3e-bc04-129e566b0ec4/documents/266c63e9-54e9-41e7-ad74-43406016853f_6fb07334-1097-4a92-b5f6-6ff1b1c303fd.html,,,,,, "Oxybis(methyl-2,1-ethanediyl) diacrylate",57472-68-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da03531d-4267-4a3e-bc04-129e566b0ec4/documents/266c63e9-54e9-41e7-ad74-43406016853f_6fb07334-1097-4a92-b5f6-6ff1b1c303fd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "Oxybis(methyl-2,1-ethanediyl) diacrylate",57472-68-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da03531d-4267-4a3e-bc04-129e566b0ec4/documents/266c63e9-54e9-41e7-ad74-43406016853f_6fb07334-1097-4a92-b5f6-6ff1b1c303fd.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,66.66 mg/kg bw/day,,rat Oxydiethylene dinitrate,693-21-0,"One chronic study for DEGDN was found in form of publication. This publication contains no detailed description (reliability ""3""). The no-effect level was determined to be 0.05 mg/kg/day.Three chronic studies for Trinitroglycerin in dogs, rats and mice were used for read-across (NOAEL (dog) - under conditions of this study, there was no NOAEL, in either sex, NOAEL (rat - prefered animals for repeated dose toxicity study) - 3.04-3.99 mg/kg bw/day, NOAEL (mice) - 96.4-114.6 mg/kg bw/day)DEGDN has classification harmonized in Annex VI of CLP as STOT RE 2*. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4ee12d9-c679-4283-9ae0-ec1d2ad6d367/documents/IUC5-a6b648eb-0631-46db-8cf3-55083e1afa75_c7301b11-4336-4073-acb3-63006998a814.html,,,,,, Oxydiethylene dinitrate,693-21-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4ee12d9-c679-4283-9ae0-ec1d2ad6d367/documents/IUC5-a6b648eb-0631-46db-8cf3-55083e1afa75_c7301b11-4336-4073-acb3-63006998a814.html,Chronic toxicity – systemic effects,oral,NOAEL,3.04 mg/kg bw/day,,rat Oxydiethylene dinitrate,693-21-0,"ACUTE TOXICITY ORALKorte jr., D.W.:Acute oral toxicity - rat: Diethyleneglycol dinitrate is a slightly toxic compound that produces signs of neurotoxicity in addition to standard symptoms of nitrate ester poisoning. Calculated MLD values were 990.4 ± 30.0 mg/kg in male Sprague-Dawley rats and 753.1 ± 35.9 mg/kg in female Sprague-Dawley rats. Acute oral toxicity - mice: DEGDN is a slightly toxic compound that appears to produce primarily behavioral and reflexive clinical signs. The calculated MLD and standard error for DEGDN are 1395 ± 59 mg/kg in male and 1321 ± 74 mg/kg in female ICR mice.Krasovsky, G.N.:The oral LD50 of DEGDN in white mice was 1250 mg/kg; in white rats 1180 mg/kg; and in guinea pigs 1250 mg/kg. In all species, acute poisoning was characterized by cyanosis (blockage of cellular respiration by massive formation of methemoglobin) and by symptoms of damage to the central nervous system.The clinical signs observed in all studies reported for DEGDN are similiar with the exception that cyanosis was not observed in study in ICR Mice (Korte jr.). Krasovsky have reported that cyanosis was observed in rats and mice following acute oral administration of DEGDN. The failure to observe cyanosis in the animals in study in ICR Mice most probably reflects the difficulty in detecting cyanotic changes in mice under the artifical (fluorescent) light conditions of the animal facility and/or in coordinating the scheduled observation periods with the kinetics in the mouse of methemoglobin formation and reduction following DEGDN administration.ACUTE TOXICITY DERMALKorte jr., D.W.: A limit dose of 2 g/kg of neat diethyleneglycol dinitrate (DEGDN) was not toxic to rabbits following a 24-hr dermal exposure. DEGDN possesses a minimal potential for acute dermal toxicity.ACUTE TOXICITY INHALATIONNo data available.HARMONIZED CLASSIFICATION according to Regulation (EC) No.1272/2008:Acute Tox. 2*, H300Acute Tox. 1*, H310Acute Tox. 2*, H330 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4ee12d9-c679-4283-9ae0-ec1d2ad6d367/documents/IUC5-8e6c1415-0b8d-4746-8efb-f96a4fcefaf8_c7301b11-4336-4073-acb3-63006998a814.html,,,,,, Oxydiethylene dinitrate,693-21-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4ee12d9-c679-4283-9ae0-ec1d2ad6d367/documents/IUC5-8e6c1415-0b8d-4746-8efb-f96a4fcefaf8_c7301b11-4336-4073-acb3-63006998a814.html,,oral,LD50,50 mg/kg bw,, Oxydiethylene dinitrate,693-21-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4ee12d9-c679-4283-9ae0-ec1d2ad6d367/documents/IUC5-8e6c1415-0b8d-4746-8efb-f96a4fcefaf8_c7301b11-4336-4073-acb3-63006998a814.html,,dermal,LD50,50 mg/kg bw,, Oxydiethylene dinitrate,693-21-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4ee12d9-c679-4283-9ae0-ec1d2ad6d367/documents/IUC5-8e6c1415-0b8d-4746-8efb-f96a4fcefaf8_c7301b11-4336-4073-acb3-63006998a814.html,,inhalation,LC50,0.002 mg/m3,, "p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline",5026-74-4," Two Repeat Dose Studies are available. In a GLP 28-day oral repeated dose study conducted in accordance with OECD 407 on the structural analogue. The systemic NOAEL was determined to be 50 mg/kg bw/day based on GI, stomach effects and atrophy of the female reproductive organs (uterus, cervix and vagina) observed at all dose levels. In a GLP, 90 day, repeat dose oral study conducted in accordance with OECD TG 408, administration of p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl) aniline to Han Wistar rats for 13 weeks did not cause any toxicologically significant finding. Mucosal hyperplasia was present in the duodenum of males and females which received 5 or 15 mg/kg/day but was considered to be an adaptive response associated with local irritation and non-adverse. The no-observed-adverse-effect level (NOAEL) in this study was considered to be 15 mg/kg/day.  In both the OECD 407 and 408 there were indications of target organ / portal of entry effects within the duodenum and stomach at 50 mg/kg bw d and 5 mg/kg bw d respectively. This is an indication of a maximum threshold dose of ca. 5 mg/kg bw d. Dosing above this level is likely to result in damage to the GI tract epithelial layer and lead to physiological changes resulting from toxic overload rather than systemic toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b8e7407-4a60-45ef-a778-1dfd16361fdd/documents/IUC5-80e54f3a-bd94-4277-b901-51f19e3239f3_6e47a3ab-af27-48aa-87b2-55d648d9c606.html,,,,,, "p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline",5026-74-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b8e7407-4a60-45ef-a778-1dfd16361fdd/documents/IUC5-80e54f3a-bd94-4277-b901-51f19e3239f3_6e47a3ab-af27-48aa-87b2-55d648d9c606.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline",5026-74-4,"In the first acute oral toxicity test conducted according to OECD 401 guideline and without GLP principles, the test substance is slightly toxic in Chinese hamster and the LD50 was determined to be 2739 mg/kg bw.In the second acute oral toxicity test conducted according to OECD 401 guideline and without GLP principles, the test substance is harmful in Mouse and the LD50 was determined to be 1413 mg/kg bw.In the third acute oral toxicity test conducted according to OECD 401 guideline and without GLP principles, the test substance is slightly toxic in rats and the LD50 was determined to be 1037 mg/kg bw.In the acute dermal toxicity test conducted according to OECD 402 guideline and without GLP principles, the test substance is practically nontoxic in rats and the LD50 was determined to be greater tahn 4000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b8e7407-4a60-45ef-a778-1dfd16361fdd/documents/IUC5-96041ee3-0456-476f-9067-693772d12179_6e47a3ab-af27-48aa-87b2-55d648d9c606.html,,,,,, "p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline",5026-74-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b8e7407-4a60-45ef-a778-1dfd16361fdd/documents/IUC5-96041ee3-0456-476f-9067-693772d12179_6e47a3ab-af27-48aa-87b2-55d648d9c606.html,,oral,LD50,"1,037 mg/kg bw",adverse effect observed, "p-(2,3-epoxypropoxy)-N,N-bis(2,3-epoxypropyl)aniline",5026-74-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b8e7407-4a60-45ef-a778-1dfd16361fdd/documents/IUC5-96041ee3-0456-476f-9067-693772d12179_6e47a3ab-af27-48aa-87b2-55d648d9c606.html,,dermal,LD50,"4,000 mg/kg bw",no adverse effect observed, p-(trifluoromethoxy)phenyl isocyanate,35037-73-1,"Acute oral: Similar to OECD 401; Wistar rat; LD50(female): 1525 mg/kg bw, LD50(male): 2170 mg/kg bw Acute inhalation: Similar to OECD 403; Wistar rat; LD50: 22.5 - 68.5 mg/m3 (0.0225 - 0.0685 mg/L) Acute dermal: Similar to OECD 402; Wistar rat; LD50(female): ca. 670 mg/kg bw, LD50(male): ca. 268 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be6dfe82-deaa-4aad-ba57-32ceeb3d0f3d/documents/IUC5-80260ffc-8abf-4934-a31e-a7ff53c89b4d_44c1f2d3-334e-4e00-a9b5-b87cc6c7d4f1.html,,,,,, p-(trifluoromethoxy)phenyl isocyanate,35037-73-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be6dfe82-deaa-4aad-ba57-32ceeb3d0f3d/documents/IUC5-80260ffc-8abf-4934-a31e-a7ff53c89b4d_44c1f2d3-334e-4e00-a9b5-b87cc6c7d4f1.html,,oral,LD50,"1,525 mg/kg bw",adverse effect observed, p-(trifluoromethoxy)phenyl isocyanate,35037-73-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be6dfe82-deaa-4aad-ba57-32ceeb3d0f3d/documents/IUC5-80260ffc-8abf-4934-a31e-a7ff53c89b4d_44c1f2d3-334e-4e00-a9b5-b87cc6c7d4f1.html,,dermal,LD50,268 mg/kg bw,adverse effect observed, p-(trifluoromethoxy)phenyl isocyanate,35037-73-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be6dfe82-deaa-4aad-ba57-32ceeb3d0f3d/documents/IUC5-80260ffc-8abf-4934-a31e-a7ff53c89b4d_44c1f2d3-334e-4e00-a9b5-b87cc6c7d4f1.html,,inhalation,LC50,22.5 mg/m3,adverse effect observed, "p,p',p''-tris(diethylamino)trityl alcohol",596-49-6," 4-(Diethylamino)-alpha,alpha-bis(4-(diethylamino)phenyl)benzenemethanol is not likely to be toxic upon repeated oral exposure by oral route. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0bc45b4-0726-4f9d-827e-30b4939ccffc/documents/IUC5-313583b1-5ad8-4df8-bbdc-9385b407f16a_673919e2-6d30-4066-a224-e4ca0eaad349.html,,,,,, "p,p',p''-tris(diethylamino)trityl alcohol",596-49-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/d0bc45b4-0726-4f9d-827e-30b4939ccffc/documents/IUC5-313583b1-5ad8-4df8-bbdc-9385b407f16a_673919e2-6d30-4066-a224-e4ca0eaad349.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "p,p',p''-tris(diethylamino)trityl alcohol",596-49-6," p,p',p''-tris(diethylamino)trityl alcohol;ethyl violet base is likely to be non hazardous by oral route of exposure ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0bc45b4-0726-4f9d-827e-30b4939ccffc/documents/IUC5-2952d3b5-8065-4a80-baff-3933642829ad_673919e2-6d30-4066-a224-e4ca0eaad349.html,,,,,, "p,p',p''-tris(diethylamino)trityl alcohol",596-49-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0bc45b4-0726-4f9d-827e-30b4939ccffc/documents/IUC5-2952d3b5-8065-4a80-baff-3933642829ad_673919e2-6d30-4066-a224-e4ca0eaad349.html,,oral,LD50,"2,304 mg/kg bw",no adverse effect observed, "p,p',p''-tris(dimethylamino)trityl alcohol",467-63-0," The acute oral toxicity of test chemical in test animals was observed to be between 300 to 2000 mg/kg body weight. And hence, the test chemical can be classified as Acute toxicity Category 4 according to CLP regulation. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/881c11e0-0cb7-46fc-8d9b-75f882851ad7/documents/6604fd22-47f2-48fd-a608-b90562928cf6_28d7ab7a-f353-4823-bafc-b8d6f5852c23.html,,,,,, "p,p',p''-tris(dimethylamino)trityl alcohol",467-63-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/881c11e0-0cb7-46fc-8d9b-75f882851ad7/documents/6604fd22-47f2-48fd-a608-b90562928cf6_28d7ab7a-f353-4823-bafc-b8d6f5852c23.html,,oral,LD50,770 mg/kg bw,no adverse effect observed, "p-[(5-cyano-1,6-dihydro-2-hydroxy-1,4-dimethyl-6-oxo-3-pyridyl)azo]-N-(2-ethylhexyl)benzamide",30449-81-1," No acutely toxic effects were observed in rats via oral, inhalation and dermal exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2e66a0c-d181-49f4-8c08-beeb0191e336/documents/251034ea-da16-48fa-9453-1d1c79f1a75f_77cedce3-cf3e-45a0-b7ea-f9cd7f6fb994.html,,,,,, "p-[4,5-dihydro-4-[[2-methoxy-5-methyl-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid",60958-41-0," Acute Oral Toxicity:  Acute oral toxicity dose was predicted based on OECD QSAR toolbox for target substance 4-{4-[(E)-2-{2-methoxy-5-methyl-4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl]-3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl}benzene-1-sulfonic (60958-41-0) was estimated to be 2188.96 mg/kg bwand for differentstudies available on the structurally similar read across substance Aluminium, 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (68683-95-9) was considered to be >2000 mg/kg bw and 5000 mg/kg bw for female rats and for the functionally similar read across substance disodium (5E)-5-[2-(2-methoxy-5-methyl-4-sulfonatophenyl)hydrazin-1-ylidene]-6-oxo-5,6-dihydronaphthalene-2-sulfonate (25956-17-6) was considered to be >10000 mg/kg bw for rats. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 4-{4-[(E)-2-{2-methoxy-5-methyl-4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl]-3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl}benzene-1-sulfonic (60958-41-0) can be classified as category V of acute oral toxicity. Acute Dermal Toxicity: Acute dermal toxicity dose was predicted based on OECD QSAR toolbox for target substance 4-{4-[(E)-2-{2-methoxy-5-methyl-4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl]-3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl}benzene-1-sulfonic (60958-41-0) was estimated to be 21910.49 mg/kg bwand for differentstudies available on the structurally similar read across substance Aluminium, 6-hydroxy-5-[(2-methoxy-5-methyl-4-sulfophenyl)azo]-2-naphthalenesulfonic acid complex (68683-95-9) was considered to be >2000 mg/kg bw for male and female rats ; for the functionally similar read across substance disodium (5E)-5-[2-(2-methoxy-5-methyl-4-sulfonatophenyl)hydrazin-1-ylidene]-6-oxo-5,6-dihydronaphthalene-2-sulfonate (25956-17-6) was considered to be >10000 mg/kg bw for rabbits and for the closely related read across substance 4-Formylmorpholine (4394-85-8) was considered to be >16000 mg/kg bw for rabbits. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,4-{4-[(E)-2-{2-methoxy-5-methyl-4-[2-(sulfooxy)ethanesulfonyl]phenyl}diazen-1-yl]-3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl}benzene-1-sulfonic (60958-41-0) can be classified as category V of acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8730b9b4-6f0f-412a-90ab-b388bdc92f8d/documents/9df4f1d0-a598-47f2-b4b1-33b64c35893d_193b1169-ddc5-4464-a6e5-d7404167b83f.html,,,,,, "p-[4,5-dihydro-4-[[2-methoxy-5-methyl-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid",60958-41-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8730b9b4-6f0f-412a-90ab-b388bdc92f8d/documents/9df4f1d0-a598-47f2-b4b1-33b64c35893d_193b1169-ddc5-4464-a6e5-d7404167b83f.html,,oral,LD50,"2,188.96 mg/kg bw",no adverse effect observed, "p-[4,5-dihydro-4-[[2-methoxy-5-methyl-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid",60958-41-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8730b9b4-6f0f-412a-90ab-b388bdc92f8d/documents/9df4f1d0-a598-47f2-b4b1-33b64c35893d_193b1169-ddc5-4464-a6e5-d7404167b83f.html,,dermal,LD50,"21,910.49 mg/kg bw",no adverse effect observed, "p-[4,5-dihydro-4-[[2-methoxy-5-methyl-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt",62121-75-9," A daily oral administration of the test item Reactive Yellow 15 to male and female Wistar rats at dose levels of 1000 mg (500 mg from study day 38 to 41 onwards for the female animals), 300 mg and 100 mg/kg body weight over a time period of 41-43 days for males and 54-66 days for females resulted in some minor animal behavioral changes observed in male and female animals predominately of the high dose groups, alterations in water consumption in male (main) and female (recovery) high dose groups and changes in T4 hormone levels in the high dose group. Findings for T4 levels could not be seen after a 14-day recovery period. The findings were not considered adverse. As the findings could not be associated with a substantial impact on the animal’s health, the NOAEL regarding the repeated dose toxicity was set to 1000 mg/kg body weight for the male and female animals when administered for at least 41 days. All results show that the physicochemical properties of the substance are responsible for the deaths within the female dose groups. Toxicological properties, which should have been taken into account for the determination of the NOAEL, have not been observed in those animals. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b4f4c7a-faa3-420c-bc5b-1dc4fe6e9831/documents/e310d1ec-9c88-46ce-8060-36a53669bd34_f753c946-7e21-49c1-b6de-5aebeac12a0d.html,,,,,, "p-[4,5-dihydro-4-[[2-methoxy-5-methyl-4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonic acid, sodium salt",62121-75-9," Based on a weight-of-evidence approach with three acute toxicity (oral, gavage) studies, the test item is not acutely toxic up to 5000 mg/kg bw in female rats. No adverse effects (clinical signs, symptoms, behaviour) were detected. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b4f4c7a-faa3-420c-bc5b-1dc4fe6e9831/documents/dd4beee7-f844-4bb2-8469-26e73bb76dd3_f753c946-7e21-49c1-b6de-5aebeac12a0d.html,,,,,, Palladium (II) di(4-oxopent-2-en-2-oate),14024-61-4," The repeated-dose toxicity of palladium(II) di(4-oxopent-2-en-2-oate) (Pdacac) was assessed in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test according to OECD TG 422 and in accordance with GLP. Rats (10/sex/group) were given daily oral gavage doses of 3, 10 or 30 mg/kg bw, throughout the pre-mating and mating periods (total 33 days' treatment for males), and (for females), throughout gestation and lactation (total 51 - 63 days' treatment). Two high-dose females died during the study. Males and females in the high-dose group were found to have reduced body weights relative to controls.    The critical adverse effect was hypertrophy of the adrenal cortex, seen in intermediate- and high-dose parental animals of both sexes. A light brown discolouration of the adrenal glands was also seen in some intermediate- and high-dose females, while in intermediate- and high-dose males, the absolute and relative weights of the adrenal glands were increased.   On the basis of these effects, the NOAEL for general systemic toxicity in this study was concluded to be 3 mg/kg bw/day (the lowest tested dose), which equates to 1.05 mg/kg bw/day for palladium, based on MWt ratios.   No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85102139-1e4b-4b23-8729-4c7b9c0eed81/documents/IUC5-419bd23e-c445-4618-a888-1a5e5a05fd77_68c75dd6-aae1-408e-8754-e6e7d65464ad.html,,,,,, Palladium (II) di(4-oxopent-2-en-2-oate),14024-61-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85102139-1e4b-4b23-8729-4c7b9c0eed81/documents/IUC5-419bd23e-c445-4618-a888-1a5e5a05fd77_68c75dd6-aae1-408e-8754-e6e7d65464ad.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,3 mg/kg bw/day,,rat Palladium (II) di(4-oxopent-2-en-2-oate),14024-61-4," In an OECD Test Guideline 425 study, to GLP, the acute oral LD50 value of palladium di(4-oxopent-2-en-2-oate) was estimated to be 2000 mg/kg bw (Matting, 2013). In a limit test conducted according to OECD Test Guideline 402, and to GLP, the acute dermal LD50 in rats of palladium di(4-oxopent-2-en-2-oate) following 24-hr skin contact was more than 2000 mg/kg bw (Matting, 2014). No relevant acute inhalation toxicity data were identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85102139-1e4b-4b23-8729-4c7b9c0eed81/documents/IUC5-87959737-fd19-41f7-b778-21f47f4ef3b5_68c75dd6-aae1-408e-8754-e6e7d65464ad.html,,,,,, Palladium (II) di(4-oxopent-2-en-2-oate),14024-61-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85102139-1e4b-4b23-8729-4c7b9c0eed81/documents/IUC5-87959737-fd19-41f7-b778-21f47f4ef3b5_68c75dd6-aae1-408e-8754-e6e7d65464ad.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Palladium dichloride,7647-10-1,"A reliable combined repeated dose toxicity and reproduction/developmental screening study in rats has been conducted with palladium dichloride (Hargitai 2023). A combined repeated dose toxicity and reproductive/developmental toxicity screening study was conducted according to OECD Test Guideline 422 and to GLP. Groups of 12 male and 12 female rats were offered diets containing 0, 600, 2000 or 6000 ppm palladium dichloride. Based on effects on body weight, body weight gain and food consumption in parental high dose animals, the NOEL for systemic toxicity was 2000 ppm palladium dichloride in diet (corresponding to 181 mg/kg bw/d). No repeated dose toxicity studies by the inhalation or dermal route were identified. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32d439a2-564d-471f-b7ba-3d64aecce604/documents/ac057784-f588-4fe5-acbf-d405357fe14b_0aacb70c-f6f7-49c7-a527-8cc7de6f345f.html,,,,,, Palladium dichloride,7647-10-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32d439a2-564d-471f-b7ba-3d64aecce604/documents/ac057784-f588-4fe5-acbf-d405357fe14b_0aacb70c-f6f7-49c7-a527-8cc7de6f345f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,181 mg/kg bw/day,,rat Palladium dichloride,7647-10-1,"In an early acute oral toxicity study, an LD50 value of approximately 576 mg/kg bw was reported in male rats gavaged with palladium dichloride dihydrate, and observed for up to 14 days. The analogous palladium dichloride LD50 is approximately 479 mg/kg bw (Holbrook et al., 1975).   No acute inhalation or dermal toxicity data were identified.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32d439a2-564d-471f-b7ba-3d64aecce604/documents/ddae2ff8-b4bb-4b47-851b-4b9a0e55f710_0aacb70c-f6f7-49c7-a527-8cc7de6f345f.html,,,,,, Palladium dichloride,7647-10-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32d439a2-564d-471f-b7ba-3d64aecce604/documents/ddae2ff8-b4bb-4b47-851b-4b9a0e55f710_0aacb70c-f6f7-49c7-a527-8cc7de6f345f.html,,oral,LD50,479 mg/kg bw,adverse effect observed, Palladium dihydroxide,12135-22-7,"In an OECD Test Guideline 422 combined repeated dose and reproductive/developmental toxicity screening study in rats, involving the gavage administration of palladium dihydroxide for at least 28 days, the systemic NOAEL was the highest tested dose (1000 mg/kg bw/day). Although some treatment related microscopic findings (mucosal discoloration in the non-glandular stomach, ileum, cecum, colon and/or rectum) were noted at dose levels of 300 and 1000 mg/kg bw/day, these were considered to result from direct (local) contact with the test substance rather than systemic toxicity (Török-Bathó, 2015).   No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Overall, good-quality database which meets REACH Standard Information Requirements. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c80bfae7-42ec-498c-848a-158828d50537/documents/IUC5-3175795b-8b52-4965-a69b-2d5c5810fb64_c1329f01-5502-4857-be5b-4333268a5ae2.html,,,,,, Palladium dihydroxide,12135-22-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c80bfae7-42ec-498c-848a-158828d50537/documents/IUC5-3175795b-8b52-4965-a69b-2d5c5810fb64_c1329f01-5502-4857-be5b-4333268a5ae2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Palladium dihydroxide,12135-22-7," No relevant acute oral, dermal or inhalation toxicity data were identified with palladium dihydroxide.Via a weight-of-evidence argumentation, the registrants consider it justified to avoid in vivo testing for acute toxicity(oral) for this substance (as exemplified in ECHA Guidance R.7a Figure 7.4-4) and consider the substance of low acute hazard via the oral route with an assumed LD50>2000 mg/kg(bw). Based on this experimental evidence, palladium dihydroxide is considered to have an LD50>2000 mg/kg(bw).  The substance is also considered to fall withing the scope of the read-across category 'Palladium, palladium monoxide and Palladium dihydroxide'. In an acute oral toxicity study, groups of male Sprague-Dawley rats were administered palladium monoxide by stomach tube and observed for 14 days. Using the prescribed statistical method, the acute oral median lethal dose (LD50) was found to exceed 4.9 g/kg bw.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): database is considered reliable and consistent to fill the REACH information requirements ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c80bfae7-42ec-498c-848a-158828d50537/documents/40286fb9-29cf-47f6-9d9c-1906c839840a_c1329f01-5502-4857-be5b-4333268a5ae2.html,,,,,, Palladium dihydroxide,12135-22-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c80bfae7-42ec-498c-848a-158828d50537/documents/40286fb9-29cf-47f6-9d9c-1906c839840a_c1329f01-5502-4857-be5b-4333268a5ae2.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Palladium dinitrate,10102-05-3," No relevant repeated dose toxicity data were identified for palladium dinitrate. However, good support for the conclusion that a repeated dose toxicity study can be waived comes from two sources. Firstly, a consideration of the known toxicity and physico-chemical properties of this compound. Palladium dinitrate is a strong acid (pH<2.0) and exhibits skin corrosivity in vitro. Secondly, there are good-quality endpoint-specific data on another palladium (II) species. In a combined repeated-dose and reproductive/developmental toxicity screening test, no adverse effects were observed at daily doses of palladium(II) dihydroxide up to 1000 mg/kg bw/day. This supports the hypothesis that, even if testing were possible, palladium dinitrate would not be expected to cause any significant systemic toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dede135-67b9-40e3-80d9-074a83ad9509/documents/IUC5-3deb2aea-72f4-458e-8f50-98c8acd38317_51743360-3a28-4517-afba-7a9be46fceec.html,,,,,, Palladium dinitrate,10102-05-3," In an OECD Test Guideline 423 study, to GLP, the acute oral LD50 value of palladium dinitrate dihydrate was determined to range between 200 and 2000 mg/kg bw following gavage administration in rats (van Huygevoort, 2003a). No relevant acute dermal or inhalation toxicity data were identified. However, acute toxicity testing by a second route is not considered appropriate as palladium dinitrate is considered corrosive. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dede135-67b9-40e3-80d9-074a83ad9509/documents/IUC5-524afa88-9f35-4fb3-9764-c42c7cf2b294_51743360-3a28-4517-afba-7a9be46fceec.html,,,,,, Palladium dinitrate,10102-05-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dede135-67b9-40e3-80d9-074a83ad9509/documents/IUC5-524afa88-9f35-4fb3-9764-c42c7cf2b294_51743360-3a28-4517-afba-7a9be46fceec.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, Palladium monoxide,1314-08-5,"In an acute oral toxicity study, an LD50 of greater than 4.9 g/kg bw was reported in male rats gavaged with palladium monoxide, and observed for up to 14 days (Holbrook et al., 1975).No relevant acute dermal or inhalation toxicity data were identified, or are required at this tonnage.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Overall, good-quality database which meets REACH Standard Information Requirements. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e879600-285b-4184-841e-4f93577e64e1/documents/IUC5-6027d0cf-1814-44c4-805c-93dd7998fa1e_7d46a06a-6b36-4400-aba0-f186215b428c.html,,,,,, Palladium monoxide,1314-08-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e879600-285b-4184-841e-4f93577e64e1/documents/IUC5-6027d0cf-1814-44c4-805c-93dd7998fa1e_7d46a06a-6b36-4400-aba0-f186215b428c.html,,oral,LD50,"4,900 mg/kg bw",no adverse effect observed, Palladium sulphate,13566-03-5," In an acute oral toxicity study, an LD50 of greater than 1400 mg/kg bw was reported in male rats gavaged with palladium sulphate, and observed for up to 14 days (Holbrook et al., 1975). In an acute oral toxicity study, an LD50 of greater than 1400 mg/kg bw was reported in male rats gavaged with palladium sulphate, and observed for up to 14 days (Holbrook et al., 1975). No relevant acute dermal or inhalation toxicity data were identified, or are required at this tonnage. No relevant acute dermal or inhalation toxicity data were identified, or are required at this tonnage. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b4835d3-d23a-461c-9a18-8588b93ecc95/documents/IUC5-07b63349-a355-4464-abe1-49b4ee3c9b20_de98fa2d-e719-4fbb-b3f9-85ed1b40c4e3.html,,,,,, Palladium sulphate,13566-03-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b4835d3-d23a-461c-9a18-8588b93ecc95/documents/IUC5-07b63349-a355-4464-abe1-49b4ee3c9b20_de98fa2d-e719-4fbb-b3f9-85ed1b40c4e3.html,,oral,LD50,"1,400 mg/kg bw",adverse effect observed, Palladium(II) acetate,3375-31-3,"In a guideline acute oral toxicity study, an LD50 of greater than 5110 mg/kg bw was reported in rats gavaged with palladium (II) acetate trimer, and observed for up to 14 days (Berthold, 1989).No relevant acute dermal or inhalation toxicity data were identified, or are required at this tonnage. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d89955fe-1ae8-4b2a-b3b9-9d6dcbef0315/documents/IUC5-2a164d49-16d4-4735-afec-1557e91c4fa2_4c0253f9-b24b-45a0-b84f-68cd5ca23624.html,,,,,, Palladium(II) acetate,3375-31-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d89955fe-1ae8-4b2a-b3b9-9d6dcbef0315/documents/IUC5-2a164d49-16d4-4735-afec-1557e91c4fa2_4c0253f9-b24b-45a0-b84f-68cd5ca23624.html,,oral,LD50,"5,110 mg/kg bw",no adverse effect observed, "Palm oil, epoxidized",1006899-79-1,"Read-across to ESBO (EC No. 232-391-0) - Repeated dose toxicity (combined chronic/carcinogenicity, NOEL (rat): 1000 mg/kg bw/day (male); 1400 mg/kg bw/day (female) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25ab3040-4c50-43e4-a17f-69ad309097f8/documents/IUC5-8443c563-9fb4-4d68-a364-f7ee991244e7_9e280d84-c1ca-4868-bf21-fa7daeefd727.html,,,,,, "Palm oil, epoxidized",1006899-79-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25ab3040-4c50-43e4-a17f-69ad309097f8/documents/IUC5-8443c563-9fb4-4d68-a364-f7ee991244e7_9e280d84-c1ca-4868-bf21-fa7daeefd727.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Palm oil, epoxidized",1006899-79-1,Read-across to ESBO (EC No. 232-391-0): LD50 >5000mg/kg bw (equivalent or similar to OECD 401)Read-across to ESBO (EC No. 232-391-0): LD50 >20 mL/kg bw (equivalent or similar to OECD 402) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25ab3040-4c50-43e4-a17f-69ad309097f8/documents/IUC5-476e715a-2179-4af8-8862-bf3d55be55de_9e280d84-c1ca-4868-bf21-fa7daeefd727.html,,,,,, "Palm oil, epoxidized",1006899-79-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25ab3040-4c50-43e4-a17f-69ad309097f8/documents/IUC5-476e715a-2179-4af8-8862-bf3d55be55de_9e280d84-c1ca-4868-bf21-fa7daeefd727.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Palm oil, epoxidized",1006899-79-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25ab3040-4c50-43e4-a17f-69ad309097f8/documents/IUC5-476e715a-2179-4af8-8862-bf3d55be55de_9e280d84-c1ca-4868-bf21-fa7daeefd727.html,,dermal,LD50,20 ,no adverse effect observed, Palmitoyl chloride,112-67-4,"NOAEL oral (rat) ≥ 1000 mg/kg bw/d (OECD 422, tested with docosanoic acid CAS 112-85-6) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1740af5e-82e0-48f0-b286-8083ee4d7237/documents/6fbc47b4-5b17-4d69-b357-38cca78223c9_e6562712-ed98-4bf5-8b42-7e6b747a26fb.html,,,,,, Palmitoyl chloride,112-67-4, The acute LD50 for male and female rats is > 5760 mg/kg (= > 6400 µL/kg) after oral application. Inhalation of a saturated vapor atmosphere does not represent an acute hazard. The acute dermal LD50 for female rats ist >1000mg/kg bw <2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1740af5e-82e0-48f0-b286-8083ee4d7237/documents/IUC5-b47bebbc-897e-48d5-b367-de175d275994_e6562712-ed98-4bf5-8b42-7e6b747a26fb.html,,,,,, Palmitoyl chloride,112-67-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1740af5e-82e0-48f0-b286-8083ee4d7237/documents/IUC5-b47bebbc-897e-48d5-b367-de175d275994_e6562712-ed98-4bf5-8b42-7e6b747a26fb.html,,oral,LD50,">=5,000 mg/kg bw",no adverse effect observed, Palmitoyl chloride,112-67-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1740af5e-82e0-48f0-b286-8083ee4d7237/documents/IUC5-b47bebbc-897e-48d5-b367-de175d275994_e6562712-ed98-4bf5-8b42-7e6b747a26fb.html,,dermal,LD50,"> 1,000 mg/kg bw",, "Paraffin waxes (Fischer-Tropsch), isomerization",2658498-20-3,"- 90d repeated dose toxicity study oral (gavage), rat (m/f), according to OECD 408, GLP, test item GTL base oil (C18-50; CAS 848301-69-9, EC 482-220-0): NOAEL (relevant for human health assessment) = 1000 mg/kg bw/day (highest dose tested); - since oral absorption decreases with increasing carbon chain length/molecule size and virtually no absorption occurs at >C50, it can be safely concluded that the results of the test item GTL base oil (covering the entire low molecular weight fraction of the registration substance up to C50) should also apply to the registration substance containing higher molecular weight constituents (C25-150, approx. 30-55 % >C50); supporting data on further closely related substances confirm the conclusion. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab59ca73-8709-47dc-b42e-1fb3070e0cdc/documents/eb1e5956-31f8-444d-bc8b-28da27cc0069_b861b043-680a-4887-8146-c0119be3f947.html,,,,,, "Paraffin waxes (Fischer-Tropsch), isomerization",2658498-20-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab59ca73-8709-47dc-b42e-1fb3070e0cdc/documents/eb1e5956-31f8-444d-bc8b-28da27cc0069_b861b043-680a-4887-8146-c0119be3f947.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Paraffin waxes (Fischer-Tropsch), isomerization",2658498-20-3,"Acute oral toxicity - OECD 420 (fixed dose method; GLP), test item GTL waxy raffinate (C15-50; CAS 848301-87-1, EC 482-130-1): LD50 in female Sprague-Dawley strain rat was estimated to be greater than 5000 mg/kg bodyweight; - OECD 420 (fixed dose method; GLP), test item GTL base oil (C18-50; CAS 848301-69-9, EC 482-220-0): LD50 in female Sprague-Dawley strain rat was estimated to be greater than 5000 mg/kg bodyweight. - Supporting data on further closely related substances confirm the low oral toxicity: in the three available studies, the LD50 in rats was also estimated to be greater than 5000 mg/kg body weight.   Acute inhalation toxicity Taking into account the very low vapour pressure of the registration substance, exposure via the inhalation route is unlikely and it is therefore considered justified to omit this endpoint information. Supporting data on the closely related substance GTL base oil 4 (covering the range, ~C18-41) indicate the low inhalation toxicity.   Acute dermal toxicity OECD 402 (fixed dose method; GLP), test item GTL base oil (C18-50; CAS 848301-69-9, EC 482-220-0): LD50 in male and female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. Supporting data on further closely related substances confirm the low dermal toxicity: in the two available studies, the LD50 in rats was estimated to be more than 2000 mg/kg body weight and more than 3600 mg/kg body weight, respectively.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab59ca73-8709-47dc-b42e-1fb3070e0cdc/documents/82b33b5b-cb46-45ff-9c45-bff8c648cd80_b861b043-680a-4887-8146-c0119be3f947.html,,,,,, "Paraffin waxes (Fischer-Tropsch), isomerization",2658498-20-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab59ca73-8709-47dc-b42e-1fb3070e0cdc/documents/82b33b5b-cb46-45ff-9c45-bff8c648cd80_b861b043-680a-4887-8146-c0119be3f947.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Paraffin waxes (Fischer-Tropsch), isomerization",2658498-20-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab59ca73-8709-47dc-b42e-1fb3070e0cdc/documents/82b33b5b-cb46-45ff-9c45-bff8c648cd80_b861b043-680a-4887-8146-c0119be3f947.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Paraffin waxes (petroleum), clay-treated",64742-43-4,"Paraffin and hydrocarbon waxes were found to be of low acute toxicity by the oral, and dermal routes.  There are no reports of acute inhalation toxicity studies of paraffin and hydrocarbon waxes; however, due to the very low vapour pressures of these substances, exposure by inhalation is not expected. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/797ad918-81ff-4ef8-ad56-6790620fb21d/documents/f15719c3-410b-4c16-9d58-061adb431c23_e20e09e5-b3bc-4d25-84b3-529bcff8620d.html,,,,,, "Paraffin waxes (petroleum), clay-treated",64742-43-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/797ad918-81ff-4ef8-ad56-6790620fb21d/documents/f15719c3-410b-4c16-9d58-061adb431c23_e20e09e5-b3bc-4d25-84b3-529bcff8620d.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rat "Paraffin waxes (petroleum), clay-treated",64742-43-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/797ad918-81ff-4ef8-ad56-6790620fb21d/documents/f15719c3-410b-4c16-9d58-061adb431c23_e20e09e5-b3bc-4d25-84b3-529bcff8620d.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,500 mg/kg bw/day",,rat "Paraffin waxes (petroleum), clay-treated",64742-43-4,The acute toxicity of paraffin and hydrocarbon waxes is low with no observed mortalities from oral (OECD 401/420) or dermal (OECD 402) applications. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/797ad918-81ff-4ef8-ad56-6790620fb21d/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_e20e09e5-b3bc-4d25-84b3-529bcff8620d.html,,,,,, "Paraffin waxes (petroleum), clay-treated",64742-43-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/797ad918-81ff-4ef8-ad56-6790620fb21d/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_e20e09e5-b3bc-4d25-84b3-529bcff8620d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Paraffin waxes (petroleum), clay-treated",64742-43-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/797ad918-81ff-4ef8-ad56-6790620fb21d/documents/e0dd8c28-78f9-4cec-8677-b9b341720079_e20e09e5-b3bc-4d25-84b3-529bcff8620d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Paraffin waxes and Hydrocarbon waxes, chloro",63449-39-8, 13 -Week Dietary Toxicity Study in Rats 13 -Week Oral (Gavage) Toxicity Study in Rats ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/523cd885-491c-4fd2-a17c-ccc112d15e41/documents/30a0bb9c-80ab-483e-8cd1-b96fdd7acf3b_3defa3bd-b181-42af-b4af-8777be660265.html,,,,,, "Paraffin waxes and Hydrocarbon waxes, chloro",63449-39-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/523cd885-491c-4fd2-a17c-ccc112d15e41/documents/30a0bb9c-80ab-483e-8cd1-b96fdd7acf3b_3defa3bd-b181-42af-b4af-8777be660265.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,900 mg/kg bw/day,,rat "Paraffin waxes and Hydrocarbon waxes, chloro",63449-39-8," There is adequate data to assess the acute toxicity of LCCPs. C20-30 LCCPs (both solid and liquid) have no observed acute toxicity at top doses in the range of 5.0  to 23 g/kg bwt in several species. It is anticipated that C18-20 liquid grade LCCPs are of very low acute toxicity based on read-across to MCCPs, which have an oral LD50 >2.0 g/kg bwt in the rat. There are no data on the acute toxicity of LCCPs following dermal administration. However, as it is anticipated that they would not be absorbed to any significant extent via this route, it is considered unnecessary to conduct such tests. Similarly, there are no data on the acute toxicity of LCCPs following inhalation, although the physico-chemical properties and the pattern of use very low vapour pressure of LCCPs make this an unlikely route of exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/523cd885-491c-4fd2-a17c-ccc112d15e41/documents/b706ff32-0e47-4556-8b22-9e9e166cd2d0_3defa3bd-b181-42af-b4af-8777be660265.html,,,,,, "Paraffin waxes and Hydrocarbon waxes, chloro",63449-39-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/523cd885-491c-4fd2-a17c-ccc112d15e41/documents/b706ff32-0e47-4556-8b22-9e9e166cd2d0_3defa3bd-b181-42af-b4af-8777be660265.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Paraffin waxes and Hydrocarbon waxes, oxidized",68153-22-0,"ORALNOAEL = 1000 mg/kg/day, 54 days rat male/female, OECD 422, Dhinsa 2005INHALATIONIn accordance with Column 1 of Annex VIII of Regulation (EC) 1907/2006 (REACH), the repeated dose toxicity study required under information point 8.6. should be conducted using the most appropriate route of administration. It is considered justified to omit the repeated dose inhalation toxicity study on the basis of exposure considerations. DERMALIn accordance with Column 1 of Annex VIII of Regulation (EC) 1907/2006 (REACH), the repeated dose toxicity study required under information point 8.6. should be conducted using the most appropriate route of administration. It is considered justified to omit the repeated dose dermal toxicity study on the basis of exposure considerations.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17bd04bf-7836-490a-bf7a-b634c13c9008/documents/692a22fa-0572-449d-bbb2-f7173bdcf524_ad2fd052-3c71-4ea3-bf30-3f960626d880.html,,,,,, "Paraffin waxes and Hydrocarbon waxes, oxidized",68153-22-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17bd04bf-7836-490a-bf7a-b634c13c9008/documents/692a22fa-0572-449d-bbb2-f7173bdcf524_ad2fd052-3c71-4ea3-bf30-3f960626d880.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Paraffin waxes and Hydrocarbon waxes, oxidized",68153-22-0," ACUTE ORAL TOXICITY The acute oral toxicity of hydrocarbon waxes was determined to be LD50 > 5000 mg/l according to a GLP compliant study (Gabriel, 1993) performed according to the standardised guideline 40 CFR Part 798, EPA Health Effects Testing Guidelines - Subpart B - General Toxicity Testing. ACUTE INHALATION TOXCITY In accordance with Column 2 (adaptation statement) of Annex VIII of Regulation (EC) 1907/2006 (REACH), the acute dermal toxicity study required under information point 8.5.2 does not need to be conducted as the nature of the substance means that it is not potentially inhalable. ACUTE DERMAL TOXICITY In accordance with Section 1 of Annex XI of Regulation (EC) 1907/2006 (REACH), the acute dermal toxicity study required under information point 8.5.3 of Annex VII does not need to be conducted as it is scientifically unjustified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17bd04bf-7836-490a-bf7a-b634c13c9008/documents/a3fe8231-8d8d-4464-8eeb-b20296a6747d_ad2fd052-3c71-4ea3-bf30-3f960626d880.html,,,,,, "Paraffin waxes and Hydrocarbon waxes, oxidized",68153-22-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17bd04bf-7836-490a-bf7a-b634c13c9008/documents/a3fe8231-8d8d-4464-8eeb-b20296a6747d_ad2fd052-3c71-4ea3-bf30-3f960626d880.html,,oral,,"5,000 mg/kg bw",no adverse effect observed, "Paraffin waxes and Hydrocarbon waxes, oxidized, lithium salts",68649-48-9,"ORALNOAEL = 1000 mg/kg/day, 54 days rat male/female, OECD 422, Dhinsa 2005INHALATIONIn accordance with Column 1 of Annex VIII of Regulation (EC) 1907/2006 (REACH), the repeated dose toxicity study required under information point 8.6. should be conducted using the most appropriate route of administration. It is considered justified to omit the repeated dose inhalation toxicity study on the basis of exposure considerations. DERMALIn accordance with Column 1 of Annex VIII of Regulation (EC) 1907/2006 (REACH), the repeated dose toxicity study required under information point 8.6. should be conducted using the most appropriate route of administration. It is considered justified to omit the repeated dose dermal toxicity study on the basis of exposure considerations.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53d175f4-e541-4440-bf5a-775669d9694f/documents/3de8dd4e-b555-4a79-8bc5-cb1abe1d9bbb_8ea58fd5-f246-457d-887c-78bcbe09903e.html,,,,,, "Paraffin waxes and Hydrocarbon waxes, oxidized, lithium salts",68649-48-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53d175f4-e541-4440-bf5a-775669d9694f/documents/3de8dd4e-b555-4a79-8bc5-cb1abe1d9bbb_8ea58fd5-f246-457d-887c-78bcbe09903e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Paraffin waxes and Hydrocarbon waxes, oxidized, lithium salts",68649-48-9," ACUTE ORAL TOXICITY The acute oral toxicity of hydrocarbon waxes was determined to be LD50 > 5000 mg/l according to a GLP compliant study (Gabriel, 1993) performed according to the standardised guideline 40 CFR Part 798, EPA Health Effects Testing Guidelines - Subpart B - General Toxicity Testing. ACUTE INHALATION TOXCITY In accordance with Column 2 (adaptation statement) of Annex VIII of Regulation (EC) 1907/2006 (REACH), the acute dermal toxicity study required under information point 8.5.2 does not need to be conducted as the nature of the substance means that it is not potentially inhalable. ACUTE DERMAL TOXICITY In accordance with Section 1 of Annex XI of Regulation (EC) 1907/2006 (REACH), the acute dermal toxicity study required under information point 8.5.3 of Annex VII does not need to be conducted as it is scientifically unjustified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53d175f4-e541-4440-bf5a-775669d9694f/documents/5c65f0bf-1ff4-4840-87c3-27235552ebc5_8ea58fd5-f246-457d-887c-78bcbe09903e.html,,,,,, "Paraffin waxes and Hydrocarbon waxes, oxidized, lithium salts",68649-48-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53d175f4-e541-4440-bf5a-775669d9694f/documents/5c65f0bf-1ff4-4840-87c3-27235552ebc5_8ea58fd5-f246-457d-887c-78bcbe09903e.html,,oral,,"5,000 mg/kg bw",no adverse effect observed, "Paraffins (petroleum), normal C>10",64771-71-7,Repeated Dose Oral 90d – NOAEL >=5000 mg/kg for rats (similar to OECD TG 408)Repeated Dose Inhalation 90d – NOAEL >= 6000 mg/m3 for rats (similar to OECD TG 413) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/163a829e-5228-4d8e-b83c-ff1687b58a99/documents/IUC5-9f4f92cc-3b5f-4fc4-8237-113138b45bb0_b602c64b-61c4-42dd-beaa-a97e1c4a1951.html,,,,,, "Paraffins (petroleum), normal C>10",64771-71-7,Acute Toxicity-Oral LD50 > 5000 mg/kg in rats (OECD TG 401)Acute Toxicity-Dermal LD50 > 2000 mg/kg in rabbits and rats (OECD TG 402)Acute Toxicity-Inhalation LC50 > 5000 mg/m3 (OECD TG 403) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/163a829e-5228-4d8e-b83c-ff1687b58a99/documents/IUC5-6a89a115-55c7-48f0-99fe-a65b48fed67e_b602c64b-61c4-42dd-beaa-a97e1c4a1951.html,,,,,, Paraquat-dichloride,1910-42-5," - Oral: reported NOAEL = 0.45 mg/kg bw/day (cation), recalculated NOAEL = 0.62 mg/kg bw/day (pure test substance); male; Beagle dogs; GLP compliant OECD 452; Kalinowski 1983. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d92dcac1-9027-40ea-8c7b-b79aec385015/documents/496a9d69-d2b7-462c-9d65-fcac786712da_be92484d-ed6d-4a58-a667-66d31024f4a8.html,,,,,, Paraquat-dichloride,1910-42-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d92dcac1-9027-40ea-8c7b-b79aec385015/documents/496a9d69-d2b7-462c-9d65-fcac786712da_be92484d-ed6d-4a58-a667-66d31024f4a8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.62 mg/kg bw/day,,dog Paraquat-dichloride,1910-42-5," - Oral: reported LD50 = 175 mg/kg bw, recalculated LD50 = 80.7 mg/kg bw; female; Sprague-Dawley rats; GLP compliant OECD 425; Pooles 2005. - Inhalation: reported LC50 between 0.6 and 1.4 mg/m3 air, recalculated LD50 between 0.8 and 1.9 mg/m3 air; female and male; Wister rats; GLP compliant similar to OECD 403; McLean 1985. - Dermal: reported LD50 >2000 mg/kg bw, recalculated LD50 >922 mg/kg bw; female and male; Sprague-Dawley; GLP compliant OECD 402; Pooles 2005. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d92dcac1-9027-40ea-8c7b-b79aec385015/documents/06bb74e7-6f6a-4f0c-af54-2dc2ca4eae88_be92484d-ed6d-4a58-a667-66d31024f4a8.html,,,,,, Paraquat-dichloride,1910-42-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d92dcac1-9027-40ea-8c7b-b79aec385015/documents/06bb74e7-6f6a-4f0c-af54-2dc2ca4eae88_be92484d-ed6d-4a58-a667-66d31024f4a8.html,,oral,LD50,80.7 mg/kg bw,adverse effect observed, Paraquat-dichloride,1910-42-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d92dcac1-9027-40ea-8c7b-b79aec385015/documents/06bb74e7-6f6a-4f0c-af54-2dc2ca4eae88_be92484d-ed6d-4a58-a667-66d31024f4a8.html,,dermal,discriminating dose,922 mg/kg bw,no adverse effect observed, Paraquat-dichloride,1910-42-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d92dcac1-9027-40ea-8c7b-b79aec385015/documents/06bb74e7-6f6a-4f0c-af54-2dc2ca4eae88_be92484d-ed6d-4a58-a667-66d31024f4a8.html,,inhalation,LC50,0.8 mg/m3,adverse effect observed, p-benzoquinone dioxime,105-11-3,"Oral: Weight of evidence: LOAEL (rat) : >= 680 ppm (or >= 34 mg/kg bw/day) ; male female, dietary eq. or similar to OECD TG 4071. LOAEL (rat) sub-chronic (7 weeks administration) : >= 680 ppm (or >= 34 mg/kg bw/day) ; male female, dietary, eq. or similar to OECD TG 407, 1979Based upon body weight and body weight gain findings only.Supporting information:2. Oral: NOAEL (rat – general toxicity and reproductive/developmental toxicity) : >= 75 mg/kg bw/day ; male/female, oral gavage, OECD TG 421, 2023With the related 10-day Dose Range Finder (DRF) indicating dose levels of 225 and 125 mg/kg bw/day were unsuitable for use in the subsequent OECD TG 421 study as both are in excess of the maximum tolerated dose, due to mortalities (terminated in extremis at 225 mg/kg bw/day) and severe continuous weight loss (up to 19% at 225 mg/kg bw/day and 11% and 125 mg/kg bw/day) and reduced food consumption during 10 days of dosing. In addition, clinical signs of toxicity were noted at these dose levels. There were no macroscopic findings at 125 mg/kg bw/day and 75 mg/kg bw/day) 3. LOAEL (rat) chronic : 104-week (diet) carcinogenicity study: LOAEL >= 375 ppm (or >= 18.75 mg/kg bw/day) to urinary system – bladder, eq. or similar to OECD TG 453, 1979There are no relevant micropathological findings particularly in the absence of mortality and/or where completed: no histopathological findings within any study other than the indicated adverse neoplasm findings within the chronic carcinogenicity study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db5ab0e2-d312-4a34-a966-80b8d7bcd497/documents/fbb7ff18-ab7e-42e9-9f10-4b8793eae245_75f20587-85cc-4f8c-ab23-f00f02fe2435.html,,,,,, p-benzoquinone dioxime,105-11-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db5ab0e2-d312-4a34-a966-80b8d7bcd497/documents/fbb7ff18-ab7e-42e9-9f10-4b8793eae245_75f20587-85cc-4f8c-ab23-f00f02fe2435.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,34 mg/kg bw/day,,rat p-benzoquinone dioxime,105-11-3,"Oral: Weight of Evidence: LD50 > 300 and < 2000 mg/kg bw 1. Oral: LD50(rat) = 464 mg/kg bw rat, equiv. or sim. to OECD 401, 1973 2. Oral: LD50(mouse) = 1420 mg/kg bw mouse, equiv. or sim. to OECD 401, 1964 3. Supporting information: Oral: LD50(rat) = < 500 mg/kg bw rat, based on 6 out of 8 lethality at 48 hours: single dose of substance at 500 mg/kg bw in 0.3% Methrocel K15M Premium vehicle via oral gavage), within eq. or similar to OECD TG 474 - Mammalian Erythrocyte Micronucleus Test, Westmoreland et al., 1992 Inhalation: LC50 (rat) = > 5.0 mg/L (male/female) time-weighted mean concentration, OECD TG 436, 2018 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db5ab0e2-d312-4a34-a966-80b8d7bcd497/documents/39bfcb65-b241-4b9e-8511-e073022ab405_75f20587-85cc-4f8c-ab23-f00f02fe2435.html,,,,,, p-benzoquinone dioxime,105-11-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db5ab0e2-d312-4a34-a966-80b8d7bcd497/documents/39bfcb65-b241-4b9e-8511-e073022ab405_75f20587-85cc-4f8c-ab23-f00f02fe2435.html,,oral,LD50,464 mg/kg bw,adverse effect observed, p-benzoquinone dioxime,105-11-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db5ab0e2-d312-4a34-a966-80b8d7bcd497/documents/39bfcb65-b241-4b9e-8511-e073022ab405_75f20587-85cc-4f8c-ab23-f00f02fe2435.html,,inhalation,discriminating conc.,"5,000 mg/m3",no adverse effect observed, p-cumenesulphonic acid,16066-35-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7bd9890f-db78-4460-8e18-3dcada0476a6/documents/9564a710-849b-46f2-942d-ad56eb2e010e_4dba6aeb-445b-47b5-9cd9-82c65b4cb50f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat p-cumenesulphonic acid,16066-35-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7bd9890f-db78-4460-8e18-3dcada0476a6/documents/1d795dc9-077a-45ac-92a8-6119f73cd476_4dba6aeb-445b-47b5-9cd9-82c65b4cb50f.html,,oral,LD50,"1,410 mg/kg bw",no adverse effect observed, Pent-1-ene,109-67-1," OECD 422 (read-across, GLP, Key, rel.1): NOAEC = 8000 ppm (18359 mg of but-1-ene /m3), ca. 22947 mg of pent-1-ene /m3 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a71c22b-38c5-4f4f-9750-ed7742941c4e/documents/0b35fae2-8b86-4d15-a71f-a9b4e8208755_e459fe8e-8f7d-4fe0-a36d-de2ca9883d4f.html,,,,,, Pent-1-ene,109-67-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a71c22b-38c5-4f4f-9750-ed7742941c4e/documents/0b35fae2-8b86-4d15-a71f-a9b4e8208755_e459fe8e-8f7d-4fe0-a36d-de2ca9883d4f.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"22,947 mg/m3",,rat Pent-1-ene,109-67-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a71c22b-38c5-4f4f-9750-ed7742941c4e/documents/0b35fae2-8b86-4d15-a71f-a9b4e8208755_e459fe8e-8f7d-4fe0-a36d-de2ca9883d4f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"22,947 mg/m3",no adverse effect observed,rat Pent-1-ene,109-67-1," - Acute oral toxicity: 2000 < LD50 < 5000 mg/kg bw (sim. OECD 401, rel.2) - Acute inhalation toxicity: LC50 > 10000 ppm (ca. 28684 mg/m3of pent-1-ene) (based on a read across on butene-2, OECD 403, rel.1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a71c22b-38c5-4f4f-9750-ed7742941c4e/documents/2d24dbaf-b303-4dae-8340-c9ccd3562910_e459fe8e-8f7d-4fe0-a36d-de2ca9883d4f.html,,,,,, Pent-1-ene,109-67-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a71c22b-38c5-4f4f-9750-ed7742941c4e/documents/2d24dbaf-b303-4dae-8340-c9ccd3562910_e459fe8e-8f7d-4fe0-a36d-de2ca9883d4f.html,,oral,LD50,"4,597 mg/kg bw",no adverse effect observed, Pent-1-ene,109-67-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a71c22b-38c5-4f4f-9750-ed7742941c4e/documents/2d24dbaf-b303-4dae-8340-c9ccd3562910_e459fe8e-8f7d-4fe0-a36d-de2ca9883d4f.html,,inhalation,LC50,"28,684 mg/m3",, Pent-3-enenitrile,4635-87-4,"The oral NOAEL is 50 mg/kg bw/day. Inhal NOAEL could not be determined (test not reliable). Dermal NOAEL was not investigated. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline study with no deviations ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38ad23f4-9497-48e0-946d-cb244c427216/documents/885d36f9-cc0a-4424-b97d-dbb41042a941_126d5a55-6eaf-4567-b6bf-48420a988ac4.html,,,,,, Pent-3-enenitrile,4635-87-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/38ad23f4-9497-48e0-946d-cb244c427216/documents/885d36f9-cc0a-4424-b97d-dbb41042a941_126d5a55-6eaf-4567-b6bf-48420a988ac4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Pent-3-enenitrile,4635-87-4,Oral: LD50 Males: 50 -300 mg/kg bw for ratDermal: LD50 Males: > 2000 mg/kg bw for ratInhalation: LC50 Males: > 0.5 - < 2.0 mg/L for rat ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38ad23f4-9497-48e0-946d-cb244c427216/documents/IUC5-b558b657-723f-4703-a1e9-faded5ee5e7d_126d5a55-6eaf-4567-b6bf-48420a988ac4.html,,,,,, Pent-3-enenitrile,4635-87-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38ad23f4-9497-48e0-946d-cb244c427216/documents/IUC5-b558b657-723f-4703-a1e9-faded5ee5e7d_126d5a55-6eaf-4567-b6bf-48420a988ac4.html,,oral,LD50,200 mg/kg bw,adverse effect observed, Pent-3-enenitrile,4635-87-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38ad23f4-9497-48e0-946d-cb244c427216/documents/IUC5-b558b657-723f-4703-a1e9-faded5ee5e7d_126d5a55-6eaf-4567-b6bf-48420a988ac4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Pent-3-enenitrile,4635-87-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38ad23f4-9497-48e0-946d-cb244c427216/documents/IUC5-b558b657-723f-4703-a1e9-faded5ee5e7d_126d5a55-6eaf-4567-b6bf-48420a988ac4.html,,inhalation,LC50,"2,000 mg/m3",adverse effect observed, Pent-4-enoyl chloride,39716-58-0,Studies with 4-Pentenoyl chloride determining the acute oral toxicity were waived according to ANNEX VII colum2 of the REACH regulation: the available information indicates that the criteria for classification of 5-Pentenoyl chloride as corrosive for the skin are met. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8ab72d2-3456-40a1-a760-dffd73c81ed9/documents/IUC5-ad76ad28-827f-4a33-995a-290ccf9308fe_22a0ccf3-30f3-4c6f-b544-8a353994f09f.html,,,,,, Pent-4-enoyl chloride,39716-58-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8ab72d2-3456-40a1-a760-dffd73c81ed9/documents/IUC5-ad76ad28-827f-4a33-995a-290ccf9308fe_22a0ccf3-30f3-4c6f-b544-8a353994f09f.html,,oral,LD50,470 mg/kg bw,, Pentaaluminium triyttrium dodecaoxide,12005-21-9,The variations L181 and L175G25C4G were tested for acute oral toxicity.The variation L175G25C4G was tested for acute toxicity via the inhalation route.The variation L181 was tested for acute dermal toxicity.None of the variations showed any acute toxicity or other treatment-related adverse effects in any of the 3 routes. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0092e1b3-febd-4dc6-a1db-3fe323879b23/documents/IUC5-6d7cab5c-0b78-46d3-81ef-41ba597fa5f1_a7ca86b5-c73b-46fa-af65-d59cf9cf929c.html,,,,,, Pentaaluminium triyttrium dodecaoxide,12005-21-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0092e1b3-febd-4dc6-a1db-3fe323879b23/documents/IUC5-6d7cab5c-0b78-46d3-81ef-41ba597fa5f1_a7ca86b5-c73b-46fa-af65-d59cf9cf929c.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Pentaaluminium triyttrium dodecaoxide,12005-21-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0092e1b3-febd-4dc6-a1db-3fe323879b23/documents/IUC5-6d7cab5c-0b78-46d3-81ef-41ba597fa5f1_a7ca86b5-c73b-46fa-af65-d59cf9cf929c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Pentaaluminium triyttrium dodecaoxide,12005-21-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0092e1b3-febd-4dc6-a1db-3fe323879b23/documents/IUC5-6d7cab5c-0b78-46d3-81ef-41ba597fa5f1_a7ca86b5-c73b-46fa-af65-d59cf9cf929c.html,,inhalation,discriminating conc.,"5,140 mg/m3",no adverse effect observed, Pentaboron sodium octaoxide,12007-92-0,"A number of oral sub-chronic and chronic studies on boric acid and disodium tetraborate decahydrate were carried out in rats, mice and dogs. In some cases, these studies are research studies (Weir and Fisher, 1972; Dixon et al, 1976; Seal and Weeth, 1980; Lee et al., 1978; Treinen and Chapin, 1991; Ku et al., 1993), but most support that boron can cause adverse haematological effects and that the main target organ of boron toxicity is the testis. The NOAEL for fertility effects is equivalent to 17.5 mg B/kg bw/day (Weir, 1966) that corresponds to a NOAEL of 66.4 mg Sodium pentaborate/kg bw/day (anhydrous, and 95.5 mg Sodium pentaborate pentahydrate/kg bw/day).  Based on the sub-acute inhalation study on boron oxide conducted in rats (Wilding, 1960), the NOAEC for systemic effects is equivalent to 146 mg B/m3 that corresponds to a NOAEC of 553.9 mg Sodium pentaborate/m3 (anhydrous, and 796.9 mg Sodium pentaborate pentahydrate/m3). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study meets generally accepted scientific standards with acceptable restrictions. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17d48b46-551a-42b7-a44c-76d1b4257310/documents/IUC5-4157e198-673c-4902-a6fd-4a3032c4c07e_e565cba0-7919-43d3-ba94-c15b34c810f2.html,,,,,, Pentaboron sodium octaoxide,12007-92-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17d48b46-551a-42b7-a44c-76d1b4257310/documents/IUC5-4157e198-673c-4902-a6fd-4a3032c4c07e_e565cba0-7919-43d3-ba94-c15b34c810f2.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,553.9 mg/m3,,rat Pentaboron sodium octaoxide,12007-92-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/17d48b46-551a-42b7-a44c-76d1b4257310/documents/IUC5-4157e198-673c-4902-a6fd-4a3032c4c07e_e565cba0-7919-43d3-ba94-c15b34c810f2.html,Chronic toxicity – systemic effects,oral,NOAEL,66.4 mg/kg bw/day,,rat Pentaboron sodium octaoxide,12007-92-0,"Acute oral studies have been performed with sodium metaborate tetrahydrate, sodium metaborate dihydrate, disodium tetraborate anhydrous, disodium tetraborate pentahydrate and disodium tetraborate decahydrate. Acute dermal and inhalation studies have been performed with disodium tetraborate pentahydrate and disodium tetraborate decahydrate. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17d48b46-551a-42b7-a44c-76d1b4257310/documents/IUC5-4dc59f98-aa26-4cfd-b7ee-6ab97393e263_e565cba0-7919-43d3-ba94-c15b34c810f2.html,,,,,, Pentaboron sodium octaoxide,12007-92-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17d48b46-551a-42b7-a44c-76d1b4257310/documents/IUC5-4dc59f98-aa26-4cfd-b7ee-6ab97393e263_e565cba0-7919-43d3-ba94-c15b34c810f2.html,,oral,LD50,"2,330 mg/kg bw",, Pentaboron sodium octaoxide,12007-92-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17d48b46-551a-42b7-a44c-76d1b4257310/documents/IUC5-4dc59f98-aa26-4cfd-b7ee-6ab97393e263_e565cba0-7919-43d3-ba94-c15b34c810f2.html,,dermal,discriminating dose,"2,000 mg/kg bw",, Pentaboron sodium octaoxide,12007-92-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17d48b46-551a-42b7-a44c-76d1b4257310/documents/IUC5-4dc59f98-aa26-4cfd-b7ee-6ab97393e263_e565cba0-7919-43d3-ba94-c15b34c810f2.html,,inhalation,discriminating conc.,"2,030 mg/m3",, Pentacalcium hydroxide tris(orthophosphate),12167-74-7, There are currently no experimental data available to assess repeated dose toxicity for the test substance. A data waiver is set in place to justify that no further repeated dose toxicity testing is required. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cd5fa83-52b4-4694-88dc-c719bba5a869/documents/ee8d70a6-0248-45b7-b723-8f691eb6d698_ed4aab75-f393-440b-9165-d2cc2e42c63b.html,,,,,, Pentacalcium hydroxide tris(orthophosphate),12167-74-7," Oral (similar to OECD 401, RL2), rat: LD50 > 5000 mg/kg bw (limit test) Inhalation (OECD 436, RL2), rat: 2 h 50 min exposure: LC50 > 2.35 mg/L (limit test) Dermal (similar to OECD 402, RL2), rabbit: LD50 > 2000 mg/kg bw (limit test) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cd5fa83-52b4-4694-88dc-c719bba5a869/documents/IUC5-aac6b677-cb06-4852-85fb-0c9c39478413_ed4aab75-f393-440b-9165-d2cc2e42c63b.html,,,,,, Pentacalcium hydroxide tris(orthophosphate),12167-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cd5fa83-52b4-4694-88dc-c719bba5a869/documents/IUC5-aac6b677-cb06-4852-85fb-0c9c39478413_ed4aab75-f393-440b-9165-d2cc2e42c63b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Pentacalcium hydroxide tris(orthophosphate),12167-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cd5fa83-52b4-4694-88dc-c719bba5a869/documents/IUC5-aac6b677-cb06-4852-85fb-0c9c39478413_ed4aab75-f393-440b-9165-d2cc2e42c63b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Pentacalcium hydroxide tris(orthophosphate),12167-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cd5fa83-52b4-4694-88dc-c719bba5a869/documents/IUC5-aac6b677-cb06-4852-85fb-0c9c39478413_ed4aab75-f393-440b-9165-d2cc2e42c63b.html,,inhalation,LC50,"2,350 mg/m3",no adverse effect observed, 2-hexyl-1-decene,13043-55-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/38cb2052-cd17-4701-a283-b92a0b4beb12/documents/IUC5-fa4295bc-e0ea-46cb-a9a9-3a75ad402c15_ebc483e5-cd59-4472-bdb0-63505a6cba6b.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Pentadecanol, branched and linear",90480-71-0,"The results for repeated oral exposure are based on read across data from a reliable 13 week oral feeding study in rats using 1-hexadecanol. This study reports a NOAEL value of > 4400 mg/kg bw. (Scientific Associates 1966a; rel 2) In addition a read across 28 day study using 1 – hexadecanol (rat, oral gavage), reported a NOAEL >1000 mg/kg bw [Henkel, 1985a; rel. 2]).A read across from a reliable 13 week dietary study in rats using hexan-1-ol reported a NOAEL of 1127 mg/kg (Scientific Associates Inc., 1966). No adverse effects were noted at any of the dose levels administered during the study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7f729674-b8ad-4c2d-afbb-24d7007b6756/documents/IUC5-c10291b8-5a75-465a-9b1b-104218a16f52_723c3bd9-1452-419e-ac12-e0804ca2fec7.html,,,,,, "Pentadecanol, branched and linear",90480-71-0,"The key study for acute oral toxicity was read across from the structural analogue hexadecanol (CAS 36653-82-4). It reports an LD50 value >2000mg/kg (Hempstoc k, 1996; rel 1). The key study for acute inhalation toxicity is read across from tetradecanol (CAS 112-72-1). A 1 hour LC50 of >1.5mgl was reported, which is the equivalent of 0.375 mg/l for a 4 hour exposure (Scientific Associates, 1977; rel 2). The acute dermal key study is also read across from tetradecanol, with the LD50 value of ca. 8000 mg/kg (Scientific Associates, 1977; rel 2). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f729674-b8ad-4c2d-afbb-24d7007b6756/documents/IUC5-aa83ca83-57e3-48d0-b1df-00d96d44f752_723c3bd9-1452-419e-ac12-e0804ca2fec7.html,,,,,, "Pentadecanol, branched and linear",90480-71-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f729674-b8ad-4c2d-afbb-24d7007b6756/documents/IUC5-aa83ca83-57e3-48d0-b1df-00d96d44f752_723c3bd9-1452-419e-ac12-e0804ca2fec7.html,,oral,LD50,"2,000 mg/kg bw",, "Pentadecanol, branched and linear",90480-71-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f729674-b8ad-4c2d-afbb-24d7007b6756/documents/IUC5-aa83ca83-57e3-48d0-b1df-00d96d44f752_723c3bd9-1452-419e-ac12-e0804ca2fec7.html,,inhalation,LC50,"8,000 mg/m3",, Pentaerythritol tetrabenzoate,4196-86-5, The potential acute toxic effect of the test item Pentaerythritol tetrabenzoate when administered as a single oral dose to Wistar rats was evaluated according to OECD Guideline 423. A limit dose of 2000 mg/kg body weight was used as a starting dose. The test item administered to 6 females at the limit dose did not cause death. The LD50 of the test item Pentaerythritol tetrabenzoate is greater than 2000 mg/kg body weight after single oral administration to female Wistar rats. Pentaerythritol tetrabenzoate does not require classification and labelling for acute oral toxicity according to CLP Regulation (EC) No. 1272/2008. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/216dda6c-97dd-4532-8599-4aafead17580/documents/f71234a9-4ec2-4386-a5dc-83da30301f17_ebf1cf44-477c-4313-b56c-7b6b5233d914.html,,,,,, Pentaerythritol tetrabenzoate,4196-86-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/216dda6c-97dd-4532-8599-4aafead17580/documents/f71234a9-4ec2-4386-a5dc-83da30301f17_ebf1cf44-477c-4313-b56c-7b6b5233d914.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Pentaerythritol, ethoxylated, esters with acrylic acid",51728-26-8, The NOAEL for systemic effects was 75 mg/kg bw (the highest dose level used) in a repeated dose toxicity/screening reprotoxicity study with PETIA according to OECD guideline No. 422. (lowest NOAEL of the key and supporting studies) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/decb79f2-f029-4f53-b8ff-c88739be1e4d/documents/97fa72d5-e10c-458d-be27-6078db691695_fe5598ed-ea05-4137-b803-8ce14699a2d0.html,,,,,, "Pentaerythritol, ethoxylated, esters with acrylic acid",51728-26-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/decb79f2-f029-4f53-b8ff-c88739be1e4d/documents/97fa72d5-e10c-458d-be27-6078db691695_fe5598ed-ea05-4137-b803-8ce14699a2d0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat "Pentaerythritol, ethoxylated, esters with acrylic acid",51728-26-8,"The test subtance is not acutely toxic for the oral and dermal route. In both studies, the LD50 is >2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/decb79f2-f029-4f53-b8ff-c88739be1e4d/documents/3767af29-1939-49b2-9e05-548d71bf83b6_fe5598ed-ea05-4137-b803-8ce14699a2d0.html,,,,,, "Pentaerythritol, ethoxylated, esters with acrylic acid",51728-26-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/decb79f2-f029-4f53-b8ff-c88739be1e4d/documents/3767af29-1939-49b2-9e05-548d71bf83b6_fe5598ed-ea05-4137-b803-8ce14699a2d0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Pentaerythritol, ethoxylated, esters with acrylic acid",51728-26-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/decb79f2-f029-4f53-b8ff-c88739be1e4d/documents/3767af29-1939-49b2-9e05-548d71bf83b6_fe5598ed-ea05-4137-b803-8ce14699a2d0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Pentaerythritol, propoxylated",9051-49-4,"NOAEL (28 days repeated dose, Wistar): ≥ 1000 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1173e3eb-42ba-4eda-b6dd-cd0f4301a192/documents/IUC5-69a198a5-2185-49f9-a366-8485357b65d7_50cc4d9b-fbd4-45a6-a27f-6d039acf77f4.html,,,,,, "Pentaerythritol, propoxylated",9051-49-4,"single dose LD50 oral > 2500 mg/kg b.w (OECD 423) and 20,800 mg/kg b.w. (OECD 401). single dose LD50 dermal > 2000 mg/kg b.w. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1173e3eb-42ba-4eda-b6dd-cd0f4301a192/documents/IUC5-dcec1c60-fa24-4c31-8626-d57ae9d59377_50cc4d9b-fbd4-45a6-a27f-6d039acf77f4.html,,,,,, Pentafluoroethane,354-33-6,Subacute and subchronic inhalation studies in rats ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34adc6a0-11e7-4375-bac1-7ab2e864fecc/documents/572a98ec-c3dc-4ac3-b637-2f69c59be106_24634dd2-7318-48bf-94e2-fff36292c1dd.html,,,,,, Pentafluoroethane,354-33-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34adc6a0-11e7-4375-bac1-7ab2e864fecc/documents/572a98ec-c3dc-4ac3-b637-2f69c59be106_24634dd2-7318-48bf-94e2-fff36292c1dd.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"245,440 mg/m3",, Pentafluoroethane,354-33-6,LC50 > 800000 ppm (3927000 mg/m3) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34adc6a0-11e7-4375-bac1-7ab2e864fecc/documents/6cf2ea02-2461-4933-826c-e961710810fe_24634dd2-7318-48bf-94e2-fff36292c1dd.html,,,,,, Pentalead tetraoxide sulphate,12065-90-6," Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/524f34e5-3f72-4796-84cc-0e54f5338a3b/documents/55240df1-e7fa-4fe8-8269-766f9e1416fc_8a8a6593-b23a-4a2f-9db0-08b7ff65d41e.html,,,,,, Pentalead tetraoxide sulphate,12065-90-6, Inorganic lead compounds do not exhibit toxicity in acute toxicity tests with experimental animals. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/524f34e5-3f72-4796-84cc-0e54f5338a3b/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_8a8a6593-b23a-4a2f-9db0-08b7ff65d41e.html,,,,,, Pentalead tetraoxide sulphate,12065-90-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/524f34e5-3f72-4796-84cc-0e54f5338a3b/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_8a8a6593-b23a-4a2f-9db0-08b7ff65d41e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Pentalead tetraoxide sulphate,12065-90-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/524f34e5-3f72-4796-84cc-0e54f5338a3b/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_8a8a6593-b23a-4a2f-9db0-08b7ff65d41e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Pentalead tetraoxide sulphate,12065-90-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/524f34e5-3f72-4796-84cc-0e54f5338a3b/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_8a8a6593-b23a-4a2f-9db0-08b7ff65d41e.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "1,5-Diisocyanatopentane",4538-42-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e7a9c28-53e6-4f45-9478-9c51755f07b8/documents/80bc4623-9d8d-4023-ab34-74ad074abcce_103ed6e8-8ce6-4d38-95bc-320558a6ab24.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.035 mg/m3,adverse effect observed,rat "1,5-Diisocyanatopentane",4538-42-5,"Migrated Data from field(s)Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is GLP-compliant and has a high quality (Klimisch score=1)Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The study is GLP-compliant and has a high quality (Klimisch score=1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e7a9c28-53e6-4f45-9478-9c51755f07b8/documents/d405c1d0-3f7a-4d76-bac9-f4dc5b19ef27_103ed6e8-8ce6-4d38-95bc-320558a6ab24.html,,,,,, "1,5-Diisocyanatopentane",4538-42-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e7a9c28-53e6-4f45-9478-9c51755f07b8/documents/d405c1d0-3f7a-4d76-bac9-f4dc5b19ef27_103ed6e8-8ce6-4d38-95bc-320558a6ab24.html,,oral,LD50,> 50 mg/kg bw,adverse effect observed, "1,5-Diisocyanatopentane",4538-42-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e7a9c28-53e6-4f45-9478-9c51755f07b8/documents/d405c1d0-3f7a-4d76-bac9-f4dc5b19ef27_103ed6e8-8ce6-4d38-95bc-320558a6ab24.html,,inhalation,LC50,53 mg/m3,adverse effect observed, "Pentane-2,4-dione",123-54-6,"In a 14 week repeated dose inhalation toxicity study in rats 2,4-pentanedione showed substance related effects on hematological parameters, clinical and urinary chemistry at doses of 300 and 650 ppm (1,217 and 2,711 mg/m3), respectively. Based on reversible hematological, clinical as well as urinary chemical effects in the 300 ppm group and the histopathological findings in the brains and thymus in the 650 ppm group the NOEL and LOAEL of this study is defined to be 100 ppm (417 mg/m3) and 650 ppm (2711 mg/m3), respectively. These doses can be converted to a NOAEL of 144.1 mg/kg bw/d and a LOAEL of 936.7 mg/kg bw/d assuming a respiratory minute volume of 0.24 l/min and an average weight of 250 g/rat. After repeated treatment of rabbits dermally, effects on thymus, spleen and lymph nodes, hemorrhage and neuronal degeneration in several sections of the brain were seen. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5009c178-b0ee-44ed-90b3-edea1e693e79/documents/IUC5-c335f192-89be-4602-918c-fc125fca0f5a_56fca9bc-fde8-4ffd-82b9-9126e12d6ccb.html,,,,,, "Pentane-2,4-dione",123-54-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5009c178-b0ee-44ed-90b3-edea1e693e79/documents/IUC5-c335f192-89be-4602-918c-fc125fca0f5a_56fca9bc-fde8-4ffd-82b9-9126e12d6ccb.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,244 mg/kg bw/day,, "Pentane-2,4-dione",123-54-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5009c178-b0ee-44ed-90b3-edea1e693e79/documents/IUC5-c335f192-89be-4602-918c-fc125fca0f5a_56fca9bc-fde8-4ffd-82b9-9126e12d6ccb.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,417 mg/m3,, "Pentane-2,4-dione",123-54-6,"The investigation performed on the acute toxicity of the substance after administration by the oral, dermal and inhalation route show that 2,4-pentanedione has to be regarded as harmful if swallowed and toxic by inhalation and in contact with skin . ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5009c178-b0ee-44ed-90b3-edea1e693e79/documents/IUC5-948c2542-9036-4c2b-a89b-3dc3ff3e9927_56fca9bc-fde8-4ffd-82b9-9126e12d6ccb.html,,,,,, "Pentane-2,4-dione",123-54-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5009c178-b0ee-44ed-90b3-edea1e693e79/documents/IUC5-948c2542-9036-4c2b-a89b-3dc3ff3e9927_56fca9bc-fde8-4ffd-82b9-9126e12d6ccb.html,,oral,LD50,570 mg/kg bw,, "Pentane-2,4-dione",123-54-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5009c178-b0ee-44ed-90b3-edea1e693e79/documents/IUC5-948c2542-9036-4c2b-a89b-3dc3ff3e9927_56fca9bc-fde8-4ffd-82b9-9126e12d6ccb.html,,dermal,LD50,790 mg/kg bw,, "Pentane-2,4-dione",123-54-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5009c178-b0ee-44ed-90b3-edea1e693e79/documents/IUC5-948c2542-9036-4c2b-a89b-3dc3ff3e9927_56fca9bc-fde8-4ffd-82b9-9126e12d6ccb.html,,inhalation,LC50,"5,100 mg/m3",, "(2S)-N, N’-dibutyl-2-(2-ethylhexanamido)pentanediamide",486455-65-6," Acute oral toxicity The median lethal dose of the test material after single oral administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat): >2000 mg/kg body weight No acute dermal or inhalation toxicity data is available or required for this level of registration. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23c94c77-3730-43dd-a2b8-e63abdf69ad2/documents/IUC5-265f53c2-cbf0-4c12-bde7-f95c06c68d41_11c67c45-3874-4ad6-b7ac-f5db6f200ee3.html,,,,,, "(2S)-N, N’-dibutyl-2-(2-ethylhexanamido)pentanediamide",486455-65-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23c94c77-3730-43dd-a2b8-e63abdf69ad2/documents/IUC5-265f53c2-cbf0-4c12-bde7-f95c06c68d41_11c67c45-3874-4ad6-b7ac-f5db6f200ee3.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Pentapotassium ({[(hydroxyphosphinato)methyl](phosphonatomethyl)nitroryl}methyl)phosphonate,255830-15-0," No repeated dose toxicity data are available for ATMP-N-oxide-5K. Therefore, data have been read across from the category member, ATMP-H. See attachment to Section 13 for justification of read-across. In a well-conducted key chronic toxicity/carcinogenicity study, ATMP-H (powder, 100% active acid) was administered via the diet to Long-Evans rats at dose levels of 50, 150 or 500 mg active acid/kg bw/day for 24 months. The NOAEL for carcinogenicity and general toxicity was at least 500 mg active acid/kg bw/day (BioDynamics Inc., 1979c). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/139150c2-c452-400d-b3a5-403c0017a27f/documents/584df897-f247-4717-a3ec-edcc5f178557_296159d6-3bdf-4824-9f6e-88bbfa1ec541.html,,,,,, Pentapotassium ({[(hydroxyphosphinato)methyl](phosphonatomethyl)nitroryl}methyl)phosphonate,255830-15-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/139150c2-c452-400d-b3a5-403c0017a27f/documents/584df897-f247-4717-a3ec-edcc5f178557_296159d6-3bdf-4824-9f6e-88bbfa1ec541.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Pentapotassium ({[(hydroxyphosphinato)methyl](phosphonatomethyl)nitroryl}methyl)phosphonate,255830-15-0," An acute oral toxicity study, conducted according to a standard acute toxicity method and in compliance with GLP, concluded an LD50 value of >5000 mg/kg bw based on no deaths up to the highest dose tested (RBM 1991a). An acute dermal toxicity study, conducted according to a standard acute toxicity method and in compliance with GLP, concluded an LD50 value of >2000 mg/kg bw based on no deaths up to the highest dose tested (RBM, 1991b). There is no inhalation study available, however, since oral and dermal route studies are available, the inhalation endpoint is waived. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/139150c2-c452-400d-b3a5-403c0017a27f/documents/4f48a949-c206-4486-b029-abf2027a92a5_296159d6-3bdf-4824-9f6e-88bbfa1ec541.html,,,,,, Pentapotassium ({[(hydroxyphosphinato)methyl](phosphonatomethyl)nitroryl}methyl)phosphonate,255830-15-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/139150c2-c452-400d-b3a5-403c0017a27f/documents/4f48a949-c206-4486-b029-abf2027a92a5_296159d6-3bdf-4824-9f6e-88bbfa1ec541.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Pentapotassium ({[(hydroxyphosphinato)methyl](phosphonatomethyl)nitroryl}methyl)phosphonate,255830-15-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/139150c2-c452-400d-b3a5-403c0017a27f/documents/4f48a949-c206-4486-b029-abf2027a92a5_296159d6-3bdf-4824-9f6e-88bbfa1ec541.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Pentapropenyl succinic anhydride,78683-74-6,"Oral:female rats (Acute toxic class method), LD50: 2500 mg/kg bw (cut-off value) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1706355-4ace-4379-9df6-602a4530c478/documents/IUC5-f09da6a4-8bb1-430e-9a67-c4eb38aa59cc_899de878-fe03-42d7-ae7b-ccf9c158fcbd.html,,,,,, Pentapropenyl succinic anhydride,78683-74-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1706355-4ace-4379-9df6-602a4530c478/documents/IUC5-f09da6a4-8bb1-430e-9a67-c4eb38aa59cc_899de878-fe03-42d7-ae7b-ccf9c158fcbd.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, "Pentasodium 2,2'-((2,4-diamino-5-(4-methoxy-2-sulfophenylazo)-1,3-phenylene)bis(azo))bis(5-(2-(sulfonatooxyethyl)sulfonyl)benzenesulfonate",910030-59-0,"The test substance did not show any adverse effects in a repeated dose oral toxicity study. The NOEL was established at the highest tested dose of 1,000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e2b3d46-9b91-4095-96fe-53885b5d2315/documents/IUC5-3e083faa-6ebe-4770-ab48-7734cf5e281c_03469578-f06d-4dfc-acab-b8d5c930b29b.html,,,,,, "Pentasodium 2,2'-((2,4-diamino-5-(4-methoxy-2-sulfophenylazo)-1,3-phenylene)bis(azo))bis(5-(2-(sulfonatooxyethyl)sulfonyl)benzenesulfonate",910030-59-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2e2b3d46-9b91-4095-96fe-53885b5d2315/documents/IUC5-3e083faa-6ebe-4770-ab48-7734cf5e281c_03469578-f06d-4dfc-acab-b8d5c930b29b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Pentasodium 2,2'-((2,4-diamino-5-(4-methoxy-2-sulfophenylazo)-1,3-phenylene)bis(azo))bis(5-(2-(sulfonatooxyethyl)sulfonyl)benzenesulfonate",910030-59-0,"The test substance is considered to be of low acute oral and dermal toxicity with LD50 values >2,000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2e2b3d46-9b91-4095-96fe-53885b5d2315/documents/IUC5-32c4d9e5-29cf-4225-ae99-a47c1ef0e42a_03469578-f06d-4dfc-acab-b8d5c930b29b.html,,,,,, "Pentasodium 2-[[8-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3,6-disulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate",77365-64-1, Acute Oral Toxicity LD50 = 11205 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3bb5369-0577-446a-8c4c-99f0190666bf/documents/f81bd632-3278-4bc1-bd76-1c6a30e95a76_5827efcc-d271-44b6-ae30-298969256313.html,,,,,, "Pentasodium 2-[[8-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-1-hydroxy-3,6-disulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate",77365-64-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3bb5369-0577-446a-8c4c-99f0190666bf/documents/f81bd632-3278-4bc1-bd76-1c6a30e95a76_5827efcc-d271-44b6-ae30-298969256313.html,,oral,LD50,"11,205 mg/kg bw",no adverse effect observed, "Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate",68259-02-9,"The ""no-observed-adverse-effect level"" was considered to be 50 mg/kg bw/day for male and female rats when administered orally by gavage for a period of 28 days. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08ca02f1-96e3-4900-8509-361d31ee3b34/documents/IUC5-4a99e243-cde9-4f44-8e4b-289930c098d4_e123ba4c-cc31-486b-a2d0-bad3697b1207.html,,,,,, "Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate",68259-02-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08ca02f1-96e3-4900-8509-361d31ee3b34/documents/IUC5-4a99e243-cde9-4f44-8e4b-289930c098d4_e123ba4c-cc31-486b-a2d0-bad3697b1207.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate",68259-02-9,Reactive Black 039 was found to have an oral LD50 >5000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08ca02f1-96e3-4900-8509-361d31ee3b34/documents/IUC5-6e59e4e6-f526-41a3-8f0e-be9928a96f3c_e123ba4c-cc31-486b-a2d0-bad3697b1207.html,,,,,, "Pentasodium 4-amino-6-[[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-2-sulphonatophenyl]azo]-3-[(2,5-disulphonatophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate",68259-02-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08ca02f1-96e3-4900-8509-361d31ee3b34/documents/IUC5-6e59e4e6-f526-41a3-8f0e-be9928a96f3c_e123ba4c-cc31-486b-a2d0-bad3697b1207.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)",79828-43-6,The NOAEL for systemic toxicity via oral route was found to be 500 mg/kg/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ffb8db4c-90b0-4d2b-97e4-a13ea50b360e/documents/IUC5-74574517-7550-4cc4-a21c-01793974c6be_9ca8056c-fe3e-49eb-a302-2bdeaa3e5627.html,,,,,, "Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)",79828-43-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ffb8db4c-90b0-4d2b-97e4-a13ea50b360e/documents/IUC5-74574517-7550-4cc4-a21c-01793974c6be_9ca8056c-fe3e-49eb-a302-2bdeaa3e5627.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)",79828-43-6,The oral LD50 was determined to be greater than 5000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ffb8db4c-90b0-4d2b-97e4-a13ea50b360e/documents/IUC5-5c99f183-6afe-44e7-ae2d-0616f0de6052_9ca8056c-fe3e-49eb-a302-2bdeaa3e5627.html,,,,,, "Pentasodium bis[5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-5-nitrophenyl)azo]naphthalene-2,7-disulphonato(4-)]chromate(5-)",79828-43-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ffb8db4c-90b0-4d2b-97e4-a13ea50b360e/documents/IUC5-5c99f183-6afe-44e7-ae2d-0616f0de6052_9ca8056c-fe3e-49eb-a302-2bdeaa3e5627.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Pentasodium bis{7-[4-(1-butyl-5-cyano-1,2-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo)phenylsulfonylamino]-5'-nitro-3,3'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato} chromate (III)",178452-71-6," NOAEL (oral, 28 d) = 200 mg/kg/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/157e177a-3bf0-4836-a90b-c8b85a42edf2/documents/ed0d9b43-e1c4-4156-92de-b3f45be9e15f_52261b80-5b28-4c08-926f-6eb42ba65ae7.html,,,,,, "Pentasodium bis{7-[4-(1-butyl-5-cyano-1,2-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo)phenylsulfonylamino]-5'-nitro-3,3'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato} chromate (III)",178452-71-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/157e177a-3bf0-4836-a90b-c8b85a42edf2/documents/ed0d9b43-e1c4-4156-92de-b3f45be9e15f_52261b80-5b28-4c08-926f-6eb42ba65ae7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Pentasodium bis{7-[4-(1-butyl-5-cyano-1,2-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo)phenylsulfonylamino]-5'-nitro-3,3'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato} chromate (III)",178452-71-6," LD50 (rat, oral) > 2000 mg/kg bw LD50 (rat, dermal) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/157e177a-3bf0-4836-a90b-c8b85a42edf2/documents/cea73511-308d-4af2-95ad-740959dba99c_52261b80-5b28-4c08-926f-6eb42ba65ae7.html,,,,,, "Pentasodium bis{7-[4-(1-butyl-5-cyano-1,2-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo)phenylsulfonylamino]-5'-nitro-3,3'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato} chromate (III)",178452-71-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/157e177a-3bf0-4836-a90b-c8b85a42edf2/documents/cea73511-308d-4af2-95ad-740959dba99c_52261b80-5b28-4c08-926f-6eb42ba65ae7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Pentasodium bis{7-[4-(1-butyl-5-cyano-1,2-dihydro-2-hydroxy-4-methyl-6-oxo-3-pyridylazo)phenylsulfonylamino]-5'-nitro-3,3'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato} chromate (III)",178452-71-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/157e177a-3bf0-4836-a90b-c8b85a42edf2/documents/cea73511-308d-4af2-95ad-740959dba99c_52261b80-5b28-4c08-926f-6eb42ba65ae7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Pentazinc chromate octahydroxide,49663-84-5,"There are no non-human data on repeated dose effects of zinc tetraoxychromate, a sparingly water soluble chromate. Read-across from other sparingly water soluble chromates and from highly water soluble chromates are suggested. Human evidence in several studies with highly water soluble chromates show irritant and corrosive responses in relation to inhalation and dermal exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/44341569-c73c-4c61-8af6-e20eac53f69f/documents/IUC5-35ee181c-a291-4614-90c0-d50e7bc537cf_e64d9968-b45f-4576-930e-bdb121098a12.html,,,,,, Pentazinc chromate octahydroxide,49663-84-5,"Zinc tetraoxychromate is a sparingly water soluble chromate. A valid test on acute inhalation toxicity of another sparingly water soluble chromate, strontium chromate, exists and is utilised for read-across. In acute oral toxicity, a poorly described study on strontium chromate is notified but the LD50 is based on read-across from slightly water soluble calcium chromate. There is no non-human information on acute dermal toxicity of zinc tetraoxychromate. Human information on zinc tetraoxychromate is also lacking. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44341569-c73c-4c61-8af6-e20eac53f69f/documents/IUC5-e9670e61-e571-4cf5-b0bb-5f00a47e0bb3_e64d9968-b45f-4576-930e-bdb121098a12.html,,,,,, Pentazinc chromate octahydroxide,49663-84-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44341569-c73c-4c61-8af6-e20eac53f69f/documents/IUC5-e9670e61-e571-4cf5-b0bb-5f00a47e0bb3_e64d9968-b45f-4576-930e-bdb121098a12.html,,oral,LD50,327 mg/kg bw,, Pentazinc chromate octahydroxide,49663-84-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44341569-c73c-4c61-8af6-e20eac53f69f/documents/IUC5-e9670e61-e571-4cf5-b0bb-5f00a47e0bb3_e64d9968-b45f-4576-930e-bdb121098a12.html,,inhalation,LC50,770 mg/m3,, Pentyl cyanoacetate,17686-39-4,No acute toxicity expected ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1f79f3b-0ea3-48ab-a9c1-62a906a68241/documents/3b47d022-43a8-464a-876d-673a8ef0727c_01a16f4e-5a50-45c3-a589-9496349bb0b7.html,,,,,, Pentyl D-glucoside,100231-63-8," Oral (WoE, OECD 401, OECD 423), rat: LD50 > 2000 mg/kg bw Read-across from structural analogue source substances D-Glucopyranose, oligomeric, butyl glycoside (CAS 31387-97-0) and D-Glucopyranose, oligomers, decyl octyl glycosides (CAS 68515-73-1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9e81004-7119-41f4-aec4-123a03905bec/documents/9e35827d-b0b9-460c-ac62-3050346fd42b_41b8f9ac-a20f-41c6-9695-e635d629d552.html,,,,,, "Peptones, beef",91079-38-8,Repeated Dose Oral 90d – NOAEL >=1000 mg/kg for rats (according to OECD TG not indicated) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8346820a-a173-45e6-b66c-6bcfb4259687/documents/8e6c56bb-e0aa-4317-9dcf-01ef20d54eee_f6b2b52b-85ce-4fe5-8107-0b0250b973bc.html,,,,,, "Peptones, beef",91079-38-8,Acute toxicity-Oral LD50 > 2000 mg/kg in rats ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8346820a-a173-45e6-b66c-6bcfb4259687/documents/caf82f7b-ebde-43e0-a63c-a1f079bb2ba4_f6b2b52b-85ce-4fe5-8107-0b0250b973bc.html,,,,,, Peracetic acid,79-21-0,"OralSubchronic (rat, gavage, 13 weeks): NOAEL: 23.4 mg/kg bw/day (nominal) based on the TWA dose of the product (1.17 mg/kg bw/day based on PAA). Relevant findings: mortality, clinical signs and histopathological changes due to local irritative effects on trachea and lungs caused by a physical effect (reflux from the stomach due to formation of oxygen gas)   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b9371d6-45a6-4d89-bc33-c83e8959d198/documents/IUC5-e559e7ee-7dad-4e4f-bc8b-8ac9f2dd534d_d136126d-afbb-4bc9-bbbb-3d43f1002d84.html,,,,,, Peracetic acid,79-21-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b9371d6-45a6-4d89-bc33-c83e8959d198/documents/IUC5-e559e7ee-7dad-4e4f-bc8b-8ac9f2dd534d_d136126d-afbb-4bc9-bbbb-3d43f1002d84.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,23.4 mg/kg bw/day,,rat Peracetic acid,79-21-0,"Acute toxicity: oral, rat (male/female) (Guideline studies with various products containing different PAA concentrations):- LD50: > 2000 mg/kg bw (male/female) (based on product (0.15% / 0.89% peracetic acid))- LD50: 185 to 3622/kg bw (male/female) (based on product (2.6 - 17% peracetic acid))- LD50: 50 - 500 mg/kg bw (male/female) (based on product (35% peracetic acid))Acute toxicity: inhalation, rat (male/female)  (Guideline studies with various products containing different PAA concentrations):- 4h-LC50: 204 mg/m³ (4080 mg/m³ based on product containing 5% peracetic acid)-  RD50: 5.4 ppm (17 mg/m³) pure peracetic acid (generated from a mixture of peracetic acid /HP/Acetic acid)Acute toxicity: dermal (Guideline studies with various products containing different PAA concentrations):- LD50: > 2000 mg/kg bw (rat, male/female) (based on product <1% peracetic acid)- LD50: >1147 mg/kg bw (rabbit, male/female) (based on product ≥1% peracetic acid) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Several reliable guideline studies with various dose concentrations of peracetic acid were avaialble. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Several reliable guideline studies with various dose concentrations of peracetic acid were avaialble. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Several reliable guideline studies with various dose concentrations of peracetic acid were avaialble. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b9371d6-45a6-4d89-bc33-c83e8959d198/documents/IUC5-4b4fcf7e-80c5-437f-9960-5bc1f4c3b0db_d136126d-afbb-4bc9-bbbb-3d43f1002d84.html,,,,,, Peracetic acid,79-21-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b9371d6-45a6-4d89-bc33-c83e8959d198/documents/IUC5-4b4fcf7e-80c5-437f-9960-5bc1f4c3b0db_d136126d-afbb-4bc9-bbbb-3d43f1002d84.html,,oral,LD50,50 mg/kg bw,adverse effect observed, Peracetic acid,79-21-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b9371d6-45a6-4d89-bc33-c83e8959d198/documents/IUC5-4b4fcf7e-80c5-437f-9960-5bc1f4c3b0db_d136126d-afbb-4bc9-bbbb-3d43f1002d84.html,,dermal,LD50,"1,147 mg/kg bw",adverse effect observed, Peracetic acid,79-21-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b9371d6-45a6-4d89-bc33-c83e8959d198/documents/IUC5-4b4fcf7e-80c5-437f-9960-5bc1f4c3b0db_d136126d-afbb-4bc9-bbbb-3d43f1002d84.html,,inhalation,LC50,204 mg/m3,adverse effect observed, Perfluamine,338-83-0," Short Description of Key Information: Two repeated dose studies have been conducted on perfluorotripropylamine (PTPA). The results of the studies are: The No Observed Adverse Effect Level (NOAEL) is 1,000 mg/kg/day when tested according to OECD 421. The No Observed Adverse Effect Level (NOAEL) is 1,200 mg/kg/day when tested according to OECD 408. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3016ebee-8713-4719-80bd-0bdc213a7341/documents/IUC5-54fb8a21-08d0-490b-8eb4-1ba7eb4b853d_986d3118-514e-436c-bd20-19d66a4f37a5.html,,,,,, Perfluamine,338-83-0,"An acute oral toxicity study has been conducted on perfluorotriproplyamine, an acute oral study has been conducted on Fluoroinert Category member perfluoro-N-methylmorpholine, an acute inhalation toxicity study and an acute oral toxicity study have been conducted on Fluoroinert Category member FC-770, an acute oral study was conducted on Fluoroinert Category member perfluorohexane, an acute oral study was conducted on Fluoroinert Category member perfluoroheptane and five acute studies have been conducted on Fluoroinert Category member perfluorotributylamine. Classification for category members is based on experimental results for certain members of the class. Since one of the defining characteristics of the class is a lack of biological effects based on chemical and electronic properties, the results from tests (mammalian toxicity, environmental and ecotoxicity) are applicable to all members of the category. Perfluorotripropylamine results:Oral LD50>5000 mg/kg Perfluoro-N-methylmorpholine results:Oral LD50>5000 mg/kgFC-770 results: Inhalation 4 hour LC50>20 mg/lAcute Oral LD50>5000 mg/kgPerfluorohexane resultOral LD50>5 g/kgPerfluoroheptane resultOral LD50>5000 mg/kgPerfluorotributylamine results:Oral LD50> 5000 mg/kg Oral LD50>10000 mg/kgInhalation LC50>41 mg/l Inhalation LC50>17 mg/lIP LD50>34.6 g/kgThe studies on Fluoroinert Category members are considered to be applicable to perfluorotriproplyamine. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3016ebee-8713-4719-80bd-0bdc213a7341/documents/IUC5-dcd0678c-4b86-4730-b839-b4b1c81a809f_986d3118-514e-436c-bd20-19d66a4f37a5.html,,,,,, Perfluoroethane,76-16-4,"Inhalation: OECD 412. 28-day repeat dose inhalation, rat. The NOAEC was 50000 ppm (282233 mg/m3) based on the absence of effects at the highest concentration tested. Reliability = 1. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d0c9b93-48af-46ff-bd96-5237e88a9659/documents/IUC5-5a2826de-3fcc-4ce4-a598-cd777484a3b8_4f221ad9-0bfc-424d-b22d-4563f63cde97.html,,,,,, Perfluoroethane,76-16-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d0c9b93-48af-46ff-bd96-5237e88a9659/documents/IUC5-5a2826de-3fcc-4ce4-a598-cd777484a3b8_4f221ad9-0bfc-424d-b22d-4563f63cde97.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"282,233 mg/m3",,rat Perfluoroethane,76-16-4,"Oral: In accordance to REACH Annex XI Section 2; information requirement section 8.5.1, guideline testing for acute oral toxicity is technically not feasible because the test substance is a gas.Dermal: In accordance to REACH Annex XI Section 2; information requirement section 8.5.3, guideline testing for acute dermal toxicity is technically not feasible because the test substance is a gas.Inhalation: OECD 403. 4-hr LC50, rat. The LC50 was > 500000 ppm (2822327 mg/m3). Reliability = 1. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d0c9b93-48af-46ff-bd96-5237e88a9659/documents/IUC5-3538d758-239a-4775-aeb7-52b9969ded5b_4f221ad9-0bfc-424d-b22d-4563f63cde97.html,,,,,, Perfluoroethane,76-16-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d0c9b93-48af-46ff-bd96-5237e88a9659/documents/IUC5-3538d758-239a-4775-aeb7-52b9969ded5b_4f221ad9-0bfc-424d-b22d-4563f63cde97.html,,inhalation,LC50,"2,822,327 mg/m3",no adverse effect observed, Perfluoropropionyl fluoride,422-61-7," Four acute inhalation toxicity studies were conducted on PFPF.  The results of the studies were: The 4-hour acute inhalation LC50 is between 100 and 200 ppm in male and female Sprague-Dawley rats (or approximately 250 ppm, based on a 1-hour exposure). The 4-hour acute inhalation LC50 is greater than 50 ppm (LC0) in male Sprague-Dawley rats. The 4-hour acute inhalation LC50 is greater than 300 ppm (LC0) in male Sprague-Dawley rats (or greater than 850 ppm, based on a 30-minute exposure). The 4-hour acute inhalation LC50 is greater than 25 ppm but less than 79 ppm in mice. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3175c565-94ff-48f9-be01-1500878b1ff6/documents/a190dc53-6802-4806-aa4b-b5f36270d1dc_f105cba0-1e5a-4a05-bf19-a3796d0d4413.html,,,,,, Perfluoro-tert-butyl alcohol,2378-02-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c218c974-eb39-40d3-a83c-289ce369de61/documents/ac4b20c1-654f-444e-918d-923161973bae_2cf729a2-4775-41ec-aee9-f849133d2036.html,,inhalation,LC50,"10,230 mg/m3",adverse effect observed, "Perhydro-1,3,5-trinitro-1,3,5-triazine",121-82-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dcc10303-51e4-4cb3-8464-991d2888f70b/documents/IUC5-ce3389b9-f81c-4c17-b8e9-4a339e44aa1a_4ef41810-ef4e-4b8d-9635-9352c02971bb.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,165 mg/kg bw/day,,rabbit "Perhydro-1,3,5-trinitro-1,3,5-triazine",121-82-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dcc10303-51e4-4cb3-8464-991d2888f70b/documents/IUC5-ce3389b9-f81c-4c17-b8e9-4a339e44aa1a_4ef41810-ef4e-4b8d-9635-9352c02971bb.html,Chronic toxicity – systemic effects,oral,LOAEL,40 mg/kg bw/day,,rat "Perhydro-1,3,5-trinitro-1,3,5-triazine",121-82-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dcc10303-51e4-4cb3-8464-991d2888f70b/documents/IUC5-10548482-b17f-4be7-8457-bb5ae6ea966b_4ef41810-ef4e-4b8d-9635-9352c02971bb.html,,oral,LD50,71 mg/kg bw,adverse effect observed, Perrhenic acid,13768-11-1,An acute toxicity study does not need to be conducted because Perrhenic acid is classified as skin corrosive 1A. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/495f8e35-be1e-4b7c-a5c4-c512ef53e8ce/documents/IUC5-d426ca06-43ca-4119-a58e-46150fd3f0df_a62a9428-dc3f-40cd-ab34-8e76f5da7267.html,,,,,, "Perylene-3,4:9,10-tetracarboxydiimide",81-33-4,"Oral: Read-across, NOAEL (28d) >= 1000 mg/kg bw/d, rat, according to OECD 407, GLP Inhalation: Read-across, NOAEC systemic (90d) = 20 mg/m³ air, NOAEC local (90d) = 1 mg/m³ air, rat, according to OECD 413, GLP ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ba3e052-de0a-4c29-aa12-89b4ac57f2bf/documents/IUC5-2fb24d68-1f1f-41ba-8580-474346445f29_4bd4ea25-7ad7-42f6-a549-19ad45ac5fb1.html,,,,,, "Perylene-3,4:9,10-tetracarboxydiimide",81-33-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ba3e052-de0a-4c29-aa12-89b4ac57f2bf/documents/IUC5-2fb24d68-1f1f-41ba-8580-474346445f29_4bd4ea25-7ad7-42f6-a549-19ad45ac5fb1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Perylene-3,4:9,10-tetracarboxydiimide",81-33-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ba3e052-de0a-4c29-aa12-89b4ac57f2bf/documents/IUC5-2fb24d68-1f1f-41ba-8580-474346445f29_4bd4ea25-7ad7-42f6-a549-19ad45ac5fb1.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,20 mg/m3,,rat "Perylene-3,4:9,10-tetracarboxydiimide",81-33-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ba3e052-de0a-4c29-aa12-89b4ac57f2bf/documents/IUC5-2fb24d68-1f1f-41ba-8580-474346445f29_4bd4ea25-7ad7-42f6-a549-19ad45ac5fb1.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1 mg/m3,adverse effect observed, "Perylene-3,4:9,10-tetracarboxydiimide",81-33-4,"Oral: LD50 (m/f) > 10000 mg/kg bw, rat, similar to OECD TG 401, no GLP Inhalation: Read-across, LC50 (m/f) > 5.2 mg/L air, rat, according to OECD TG 403, no GLP ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ba3e052-de0a-4c29-aa12-89b4ac57f2bf/documents/IUC5-37c01940-aec8-4884-ad53-e4f17c301bd0_4bd4ea25-7ad7-42f6-a549-19ad45ac5fb1.html,,,,,, "Perylene-3,4:9,10-tetracarboxydiimide",81-33-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ba3e052-de0a-4c29-aa12-89b4ac57f2bf/documents/IUC5-37c01940-aec8-4884-ad53-e4f17c301bd0_4bd4ea25-7ad7-42f6-a549-19ad45ac5fb1.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "Perylene-3,4:9,10-tetracarboxydiimide",81-33-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ba3e052-de0a-4c29-aa12-89b4ac57f2bf/documents/IUC5-37c01940-aec8-4884-ad53-e4f17c301bd0_4bd4ea25-7ad7-42f6-a549-19ad45ac5fb1.html,,inhalation,discriminating conc.,"5,200 mg/m3",no adverse effect observed, "Perylene-3,4:9,10-tetracarboxylic dianhydride",128-69-8,"Oral: Read-across, NOAEL (28d) >= 1000 mg/kg bw/d, rat, according to OECD 407, GLP Inhalation: Read-across, NOAEC systemic (90d) = 20 mg/m³ air, NOAEC local (90d) = 1 mg/m³ air, rat, according OECD to 413, GLP ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a573b574-eae0-4a81-8879-567d487e3b82/documents/IUC5-bd4d7834-bc17-497a-bf20-9736d7e72b36_dcb351c0-826c-4abb-8095-23046e2b352a.html,,,,,, "Perylene-3,4:9,10-tetracarboxylic dianhydride",128-69-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a573b574-eae0-4a81-8879-567d487e3b82/documents/IUC5-bd4d7834-bc17-497a-bf20-9736d7e72b36_dcb351c0-826c-4abb-8095-23046e2b352a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Perylene-3,4:9,10-tetracarboxylic dianhydride",128-69-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a573b574-eae0-4a81-8879-567d487e3b82/documents/IUC5-bd4d7834-bc17-497a-bf20-9736d7e72b36_dcb351c0-826c-4abb-8095-23046e2b352a.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,20 mg/m3,,rat "Perylene-3,4:9,10-tetracarboxylic dianhydride",128-69-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a573b574-eae0-4a81-8879-567d487e3b82/documents/IUC5-bd4d7834-bc17-497a-bf20-9736d7e72b36_dcb351c0-826c-4abb-8095-23046e2b352a.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1 mg/m3,adverse effect observed, "Perylene-3,4:9,10-tetracarboxylic dianhydride",128-69-8,"Oral: LD50 (m/f) > 10000 mg/kg bw, rat, according to OECD TG 401, no GLP Inhalation: Read-across, LC50 (m/f) > 5.2 mg/L air, rat, according to OECD TG 403, no GLP ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a573b574-eae0-4a81-8879-567d487e3b82/documents/IUC5-1b62b891-c804-456b-80c6-6e8d349ff84d_dcb351c0-826c-4abb-8095-23046e2b352a.html,,,,,, "Perylene-3,4:9,10-tetracarboxylic dianhydride",128-69-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a573b574-eae0-4a81-8879-567d487e3b82/documents/IUC5-1b62b891-c804-456b-80c6-6e8d349ff84d_dcb351c0-826c-4abb-8095-23046e2b352a.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, "Perylene-3,4:9,10-tetracarboxylic dianhydride",128-69-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a573b574-eae0-4a81-8879-567d487e3b82/documents/IUC5-1b62b891-c804-456b-80c6-6e8d349ff84d_dcb351c0-826c-4abb-8095-23046e2b352a.html,,inhalation,discriminating conc.,"5,200 mg/m3",no adverse effect observed, "Petrolatum (petroleum), oxidized, Bu ester",90669-48-0,"ORALNOAEL = 1000 mg/kg bw/day (distillates (pertoleum), oxidized light), rat (male/female), OECD 422, Dhinsa (2005) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/453ca575-dcf2-415f-a35b-fd385ba7a6f1/documents/IUC5-dbfd933d-9789-41ba-bf9b-70a5f8e59ca6_c4042896-066d-4fb2-a8cf-608497375460.html,,,,,, "Petrolatum (petroleum), oxidized, Bu ester",90669-48-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/453ca575-dcf2-415f-a35b-fd385ba7a6f1/documents/IUC5-dbfd933d-9789-41ba-bf9b-70a5f8e59ca6_c4042896-066d-4fb2-a8cf-608497375460.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Petrolatum (petroleum), oxidized, Bu ester",90669-48-0,"Oral: LD50 > 2000 mg/kg bw, female rat, OECD 423, Kuthy (2012) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/453ca575-dcf2-415f-a35b-fd385ba7a6f1/documents/IUC5-70460d59-be25-438d-8ec7-76443f2a59c9_c4042896-066d-4fb2-a8cf-608497375460.html,,,,,, "Petrolatum (petroleum), oxidized, calcium salt",68425-34-3,"Data available on similar materials are sufficient to adequately characterize the repeated oral toxicity and the repeated dermal toxicity of sufficiently refined petrolatum. The data are consistent in that they demonstrate minimal effects in rats and rabbits with the exception of minimal to moderate skin irritation following repeated dermal exposures and histopathological changes with questionable relevance to humans following repeated oral exposures. Potential exposures by inhalation are expected to be low due to the low vapour pressures of petrolatum. Accordingly, it does not seem likely that there is any potential for petrolatum to produce repeated dose toxicity by an inhalation route. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a090ac7-e34f-42cd-8f1b-12ba6a5dc5bd/documents/3a6dd703-c722-49d7-8a3a-57d1159424e9_bcaf0d4e-efe3-43c2-b71b-b804f3c1d105.html,,,,,, "Petrolatum (petroleum), oxidized, calcium salt",68425-34-3,The acute toxicity of petrolatum is low with no observed mortalities from oral or dermal applications. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a090ac7-e34f-42cd-8f1b-12ba6a5dc5bd/documents/6a8ab05b-8461-48b1-ad6a-eacf0403470f_bcaf0d4e-efe3-43c2-b71b-b804f3c1d105.html,,,,,, "Petrolatum (petroleum), oxidized, calcium salt",68425-34-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a090ac7-e34f-42cd-8f1b-12ba6a5dc5bd/documents/6a8ab05b-8461-48b1-ad6a-eacf0403470f_bcaf0d4e-efe3-43c2-b71b-b804f3c1d105.html,,oral,LD50,"5,000 mg/kg bw",, "Petrolatum (petroleum), oxidized, calcium salt",68425-34-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a090ac7-e34f-42cd-8f1b-12ba6a5dc5bd/documents/6a8ab05b-8461-48b1-ad6a-eacf0403470f_bcaf0d4e-efe3-43c2-b71b-b804f3c1d105.html,,dermal,LD50,"2,000 mg/kg bw",, Petroleum resins,64742-16-1, Acute toxicity: oral - The LD50 of the test item Petroleum Resins (Kendex 0897) is greater than 2000 mg/kg body weight after single oral administration to Wistar rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06f587e0-dbbd-4f5c-a8c5-40461524e9df/documents/dc767fd5-edee-4acc-a674-1dc0e599925b_0eb1159d-fb0a-41ec-bfae-de93136e1436.html,,,,,, Petroleum resins,64742-16-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06f587e0-dbbd-4f5c-a8c5-40461524e9df/documents/dc767fd5-edee-4acc-a674-1dc0e599925b_0eb1159d-fb0a-41ec-bfae-de93136e1436.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Phenazone,60-80-0,A sub-chronic oral toxicity study in rats revealed a repeated dose NOAEL value of 100 mg/kg bw/day and a subchronic toxicity study in dogs revealed a NOAEL of 63 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9287d675-eb3b-4a94-a962-65546a759ca8/documents/IUC5-b5dc309c-660d-42ee-82dd-a1c68ccac8e7_38adfb20-336f-49ba-b168-ae98d09684e7.html,,,,,, Phenazone,60-80-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9287d675-eb3b-4a94-a962-65546a759ca8/documents/IUC5-b5dc309c-660d-42ee-82dd-a1c68ccac8e7_38adfb20-336f-49ba-b168-ae98d09684e7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,63 mg/kg bw/day,,dog Phenazone,60-80-0,"Oral LD50 values ranged from 1250 to 1807 mg/kg bw/day for cats, guinea pigs, mice and rats.  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9287d675-eb3b-4a94-a962-65546a759ca8/documents/IUC5-9a445eb0-b77c-40e9-83a5-1310815aa1ee_38adfb20-336f-49ba-b168-ae98d09684e7.html,,,,,, Phenazone,60-80-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9287d675-eb3b-4a94-a962-65546a759ca8/documents/IUC5-9a445eb0-b77c-40e9-83a5-1310815aa1ee_38adfb20-336f-49ba-b168-ae98d09684e7.html,,oral,LD50,"1,250 mg/kg bw",, Phenethyl valerate,7460-74-4," Acute Oral Toxicity: The LD50 was estimated to be 8899 mg/kg bw, when five male and five female Wistar rats were orally exposed with 2-phenylethyl pentanoate (7460-74-4) via gavage. Acute Dermal Toxicity: The LD50 was estimated to be 6654 mg/kg bw, when 5 male and 5 female Wistar outbred rats (Crl:Wl(WU)BR) were exposed occlusively with 2-phenylethyl pentanoate (746-74-4) by dermal application for 24 hours. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5e7be18-1ab9-42ca-8139-df0cf0183375/documents/bb9fabe9-637d-439f-8605-2cbaaa710449_c8e0323e-101c-44b6-a38f-f54b5a960641.html,,,,,, Phenethyl valerate,7460-74-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5e7be18-1ab9-42ca-8139-df0cf0183375/documents/bb9fabe9-637d-439f-8605-2cbaaa710449_c8e0323e-101c-44b6-a38f-f54b5a960641.html,,oral,LD50,"8,899 mg/kg bw",no adverse effect observed, Phenethyl valerate,7460-74-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5e7be18-1ab9-42ca-8139-df0cf0183375/documents/bb9fabe9-637d-439f-8605-2cbaaa710449_c8e0323e-101c-44b6-a38f-f54b5a960641.html,,dermal,LD50,"6,654 mg/kg bw",no adverse effect observed, "2,4-bis[(dodecylsulfanyl)methyl]-6-methylphenol",110675-26-8,28 day subacute study (rat): NOAEL 1000 mg/kg bw/d90d subchronic study (rat): NOAEL 1000 mg/kg bw/d (Read-across to CAS 110553-27-0)90d subchronic study (dog): NOEL 10 mg/kg bw/d (Read-across to CAS 110553-27-0) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ae3bc95-1efd-4b5d-81d4-9aaa6d23ea23/documents/d173f895-77ff-4043-9a6e-ce5bfde3e0a4_dfbb6b6c-1bdc-4271-85d3-0b24ff6277e2.html,,,,,, "2,4-bis[(dodecylsulfanyl)methyl]-6-methylphenol",110675-26-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ae3bc95-1efd-4b5d-81d4-9aaa6d23ea23/documents/d173f895-77ff-4043-9a6e-ce5bfde3e0a4_dfbb6b6c-1bdc-4271-85d3-0b24ff6277e2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2,4-bis[(dodecylsulfanyl)methyl]-6-methylphenol",110675-26-8,Acute oral toxicit: LD50 > 5000 mg/kg bw/d (no mortality occurred; Read-across to 110553-27-0).Acute dermal toxicity: LD50 > 2000 mg/kg bw/d (no mortality occurred; Read-across to 110553-27-0). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ae3bc95-1efd-4b5d-81d4-9aaa6d23ea23/documents/5a59cff3-0ccf-4dbb-8411-ba22d67edbaf_dfbb6b6c-1bdc-4271-85d3-0b24ff6277e2.html,,,,,, "2,4-bis[(dodecylsulfanyl)methyl]-6-methylphenol",110675-26-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ae3bc95-1efd-4b5d-81d4-9aaa6d23ea23/documents/5a59cff3-0ccf-4dbb-8411-ba22d67edbaf_dfbb6b6c-1bdc-4271-85d3-0b24ff6277e2.html,,oral,LD0,"5,000 mg/kg bw",no adverse effect observed, "2,4-bis[(dodecylsulfanyl)methyl]-6-methylphenol",110675-26-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ae3bc95-1efd-4b5d-81d4-9aaa6d23ea23/documents/5a59cff3-0ccf-4dbb-8411-ba22d67edbaf_dfbb6b6c-1bdc-4271-85d3-0b24ff6277e2.html,,dermal,LD0,"2,000 mg/kg bw",no adverse effect observed, "Phenol, 2,4-dinitro-, sulfurized, leuco derivatives",66241-11-0,Leuco Sulfur Black 1 did not cause any toxic effects in the repeated dose toxicity study with reproduction/developmental toxicity screening in rats (OECD 422). The limit dose of 1000 mg/kg bw/d represents the NOAEL. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/155aabc2-ec75-4815-bf5a-dcc2d44fdbd0/documents/IUC5-074041c6-f34c-4c11-9b7f-6382281125b6_332a305d-f824-4bb3-88cf-28980abb8df7.html,,,,,, "Phenol, 2,4-dinitro-, sulfurized, leuco derivatives",66241-11-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/155aabc2-ec75-4815-bf5a-dcc2d44fdbd0/documents/IUC5-074041c6-f34c-4c11-9b7f-6382281125b6_332a305d-f824-4bb3-88cf-28980abb8df7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Phenol, 2,4-dinitro-, sulfurized, leuco derivatives",66241-11-0,The LD50 oral and dermal in the rat is above 2000 mg/kg bw. Leuco Sulfur Black 1 did neither cause lethality nor clinical signs indicative of toxicity in both acute toxicity studies. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/155aabc2-ec75-4815-bf5a-dcc2d44fdbd0/documents/IUC5-ce8d63d8-f0f4-4df6-ab3a-ee2829d2e160_332a305d-f824-4bb3-88cf-28980abb8df7.html,,,,,, "Phenol, 2,4-dinitro-, sulfurized, thiosulfonated",1326-83-6," The test item did not cause adverse effects in male or female Hsd.Han: Wistar rats during the course of an OECD 422 compliant study when administered orally by gavage at 100, 300 or 1000 mg/kg bw/day. Thus, a NOAEL of 1000 mg/kg bw/day was determined. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ed4a20a-5988-4efb-b090-8c791b6c9ab4/documents/3d257682-a142-466b-8bf5-a22d9754e5c8_ef46d08a-ebc2-448c-ad76-baf1cfe539e6.html,,,,,, "Phenol, 2,4-dinitro-, sulfurized, thiosulfonated",1326-83-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ed4a20a-5988-4efb-b090-8c791b6c9ab4/documents/3d257682-a142-466b-8bf5-a22d9754e5c8_ef46d08a-ebc2-448c-ad76-baf1cfe539e6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Phenol, 2,4-dinitro-, sulfurized, thiosulfonated",1326-83-6," In an in vivo acute oral toxicity assay (acute toxicity class method, ATC) according to OECD guideline 423, an LD50 of above 2000 mg/kg bw was determined. In accordance with Regulation (EG) No 1907/2006, Annex VIII, column 2 a dermal or inhalation toxicity study was not performed. However, considering the weight of evidence, LD50/LC50 values above 2000 mg/kg bw or 5 mg/L can be expected. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ed4a20a-5988-4efb-b090-8c791b6c9ab4/documents/53b7d000-83e2-496c-95ab-57e127f34363_ef46d08a-ebc2-448c-ad76-baf1cfe539e6.html,,,,,, "Phenol, 2,4-dinitro-, sulfurized, thiosulfonated",1326-83-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ed4a20a-5988-4efb-b090-8c791b6c9ab4/documents/53b7d000-83e2-496c-95ab-57e127f34363_ef46d08a-ebc2-448c-ad76-baf1cfe539e6.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Phenol, 2,6-di-tert-butyl-, 4-(trans-4-propylcyclohexyl)-",189696-30-8, OECD 423: LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f0e0041-b6f1-42eb-bbc3-4abe13902b29/documents/b49270a9-75cf-4dce-8382-67546085b64d_3186dd7c-5eb7-4e95-868d-12eaf89f9941.html,,,,,, "Phenol, 2,6-di-tert-butyl-, 4-(trans-4-propylcyclohexyl)-",189696-30-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f0e0041-b6f1-42eb-bbc3-4abe13902b29/documents/b49270a9-75cf-4dce-8382-67546085b64d_3186dd7c-5eb7-4e95-868d-12eaf89f9941.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Phenol, 2-[4-(4-ethoxyphenyl)-6-phenyl-1,3,5-triazin-2-yl]-",252285-60-2,No adverse effects in subacute oral toxicity study up to highest dose tested. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/992e0780-834d-4ed7-a57a-85440ffa0721/documents/IUC5-a7f7d367-6ab1-4ef2-bd6a-ce03a8f3edc6_9977686b-086d-481d-8693-ff8888d4a974.html,,,,,, "Phenol, 2-[4-(4-ethoxyphenyl)-6-phenyl-1,3,5-triazin-2-yl]-",252285-60-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/992e0780-834d-4ed7-a57a-85440ffa0721/documents/IUC5-a7f7d367-6ab1-4ef2-bd6a-ce03a8f3edc6_9977686b-086d-481d-8693-ff8888d4a974.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Phenol, 2-[4-(4-ethoxyphenyl)-6-phenyl-1,3,5-triazin-2-yl]-",252285-60-2,Practically non-toxic ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/992e0780-834d-4ed7-a57a-85440ffa0721/documents/IUC5-fcbe6c61-744a-4449-b8a9-1303254f2a4d_9977686b-086d-481d-8693-ff8888d4a974.html,,,,,, "Phenol, 2-[4-(4-ethoxyphenyl)-6-phenyl-1,3,5-triazin-2-yl]-",252285-60-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/992e0780-834d-4ed7-a57a-85440ffa0721/documents/IUC5-fcbe6c61-744a-4449-b8a9-1303254f2a4d_9977686b-086d-481d-8693-ff8888d4a974.html,,oral,LD50,"2,000 mg/kg bw",, "Phenol, 2-[4-(4-ethoxyphenyl)-6-phenyl-1,3,5-triazin-2-yl]-",252285-60-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/992e0780-834d-4ed7-a57a-85440ffa0721/documents/IUC5-fcbe6c61-744a-4449-b8a9-1303254f2a4d_9977686b-086d-481d-8693-ff8888d4a974.html,,dermal,LD50,"2,000 mg/kg bw",, 2-methoxy-5-nitrophenyl acetate,53606-41-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2da5d4f8-7ab1-4c8b-afcc-ec828d2e8b8f/documents/IUC5-60c29e33-e684-4b0b-9b03-8608a9f72d99_9ca10783-dc01-40cc-9ef4-f8ba81fa7c90.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 3-[(1S)-1-(methylamino)ethyl]phenol,894079-42-6,Key study: Test method OECD 420. GLP study. No adverse effects were observed in rats after a single exposure of 2000 mg/k bw by gavage. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9aecf13-3094-40cf-a448-d4b04a92348d/documents/IUC5-3f4d87e4-d813-4536-9060-20daa00795f7_1e036c76-3c59-49bc-b723-6ab2cea326b8.html,,,,,, 3-[(1S)-1-(methylamino)ethyl]phenol,894079-42-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9aecf13-3094-40cf-a448-d4b04a92348d/documents/IUC5-3f4d87e4-d813-4536-9060-20daa00795f7_1e036c76-3c59-49bc-b723-6ab2cea326b8.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Phenol, 4-(9H-carbazol-3-ylamino)-, reaction products with sodium sulfide (Na2(Sx)) and sulfur, leuco deriv.",85940-25-6," In a study according OECD TG 422 performed with the read across substance Blue Sema (CAS No.1040873 -93 -5) 100, 300 or 1000 mg dye/kg bw/day(corresponding to 0, 115, 345 and 1150 mg test item/kg bw) were administered to rats by oral gavage. Neither signs of systemic toxicity nor adverse influence on the reproductive performance (gonad function, mating behavior, conception, parturition) were detected. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ea1e358-d508-45a7-b016-e6e902cbc54a/documents/c9770346-7723-436b-a5f8-8daa1d83f803_a9165e3c-72fd-4461-a44b-48535075d6ad.html,,,,,, "Phenol, 4-(9H-carbazol-3-ylamino)-, reaction products with sodium sulfide (Na2(Sx)) and sulfur, leuco deriv.",85940-25-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7ea1e358-d508-45a7-b016-e6e902cbc54a/documents/c9770346-7723-436b-a5f8-8daa1d83f803_a9165e3c-72fd-4461-a44b-48535075d6ad.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Phenol, 4-(9H-carbazol-3-ylamino)-, reaction products with sodium sulfide (Na2(Sx)) and sulfur, leuco deriv.",85940-25-6, In an acute oral toxicity study in rats the acute oral LD50 was determined to be > 2000 mg dye/kg bw (corresponding to > 2160 mg test item/kg bw). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ea1e358-d508-45a7-b016-e6e902cbc54a/documents/8ec6c588-bace-4457-8b00-674e23961312_a9165e3c-72fd-4461-a44b-48535075d6ad.html,,,,,, "Phenol, 4-(9H-carbazol-3-ylamino)-, reaction products with sodium sulfide (Na2(Sx)) and sulfur, leuco deriv.",85940-25-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ea1e358-d508-45a7-b016-e6e902cbc54a/documents/8ec6c588-bace-4457-8b00-674e23961312_a9165e3c-72fd-4461-a44b-48535075d6ad.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Phenol, 4-(phenylamino)-, sulfurized, leuco deriv.",85736-99-8, Oral: In a combined repeated dose study with reproduction/developmental toxicity screening (OECD 422) in rats the derived NOAEL for the parental animals was >= 1000 mg/kg bw. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7dbbef4f-805e-4611-b5ae-2886fd479a17/documents/787885cd-ca23-487b-b7ff-ed2e90524b5e_551f520a-d5e2-4462-afbe-a030b6fd67dd.html,,,,,, "Phenol, 4-(phenylamino)-, sulfurized, leuco deriv.",85736-99-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7dbbef4f-805e-4611-b5ae-2886fd479a17/documents/787885cd-ca23-487b-b7ff-ed2e90524b5e_551f520a-d5e2-4462-afbe-a030b6fd67dd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Phenol, 4-(phenylamino)-, sulfurized, leuco deriv.",85736-99-8," Acute Toxicity: oral: In an acute oral toxicity study with female rats, performed according to OECD 423 guidelines, an LD50 of >2000 mg/kg bw was determined.   Dermal: In an acute dermal toxicity study with rats, performed according to OECD 402 guidelines, an LD50 of >2000 mg/kg bw was determined. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7dbbef4f-805e-4611-b5ae-2886fd479a17/documents/73cabcf6-624b-432f-90bd-d3a77d82a0af_551f520a-d5e2-4462-afbe-a030b6fd67dd.html,,,,,, "Phenol, 4-(phenylamino)-, sulfurized, leuco deriv.",85736-99-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7dbbef4f-805e-4611-b5ae-2886fd479a17/documents/73cabcf6-624b-432f-90bd-d3a77d82a0af_551f520a-d5e2-4462-afbe-a030b6fd67dd.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Phenol, 4-(phenylamino)-, sulfurized, leuco deriv.",85736-99-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7dbbef4f-805e-4611-b5ae-2886fd479a17/documents/73cabcf6-624b-432f-90bd-d3a77d82a0af_551f520a-d5e2-4462-afbe-a030b6fd67dd.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Phenol, 4-[[4-(dimethylamino)phenyl]azo]-, reaction products with sodium sulfide (Na2(Sx)), leuco derivatives",12262-25-8," In a study according OECD TG 422 performed with the read across substance Blue Sema (CAS No.1040873 -93 -5) 100, 300 or 1000 mg dye/kg bw/day (corresponding to 0, 115, 345 and 1150 mg test item/kg bw) were administered to rats by oral gavage. Neither signs of systemic toxicity nor adversely influence on the reproductive performance (gonad function, mating behavior, conception, parturition) were detected. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d690cb09-aafc-4a3f-9bee-b8d50963606d/documents/c81f30e7-4398-42c2-8f5a-82c87c6aa5c2_9d5f57bd-fd80-4c06-86fd-ebd316ca852e.html,,,,,, "Phenol, 4-[[4-(dimethylamino)phenyl]azo]-, reaction products with sodium sulfide (Na2(Sx)), leuco derivatives",12262-25-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d690cb09-aafc-4a3f-9bee-b8d50963606d/documents/c81f30e7-4398-42c2-8f5a-82c87c6aa5c2_9d5f57bd-fd80-4c06-86fd-ebd316ca852e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Phenol, 4-[[4-(dimethylamino)phenyl]azo]-, reaction products with sodium sulfide (Na2(Sx)), leuco derivatives",12262-25-8, In an acute oral toxicity study in rats the acute oral LD50 was determined to be > 2000 mg dye/kg bw (corresponding to > 2280 mg product/kg bw). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d690cb09-aafc-4a3f-9bee-b8d50963606d/documents/9b1460da-4ae2-469f-b8fe-44d619c9cede_9d5f57bd-fd80-4c06-86fd-ebd316ca852e.html,,,,,, "Phenol, 4-[[4-(dimethylamino)phenyl]azo]-, reaction products with sodium sulfide (Na2(Sx)), leuco derivatives",12262-25-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d690cb09-aafc-4a3f-9bee-b8d50963606d/documents/9b1460da-4ae2-469f-b8fe-44d619c9cede_9d5f57bd-fd80-4c06-86fd-ebd316ca852e.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Phenol, 4-amino-, reaction products with aniline, 4-methyl-1,3-benzenediamine, p-phenylenediamine, sodium sulfide (Na2S) and sulfur",70892-38-5," Under the conditions of an OECD 422 compliant study, the read across substance (CAS 90268-98-7) administered at 100, 300 or 1000 mg/kg bw/day (corrected doses; corresponding to uncorrected doses of 110.46, 331.38 and 1104.61 mg/kg bw/day, repsectively) by oral gavage did not cause signs of systemic toxicity and did not adversely influence the reproductive performance (gonad function, mating behavior, conception, parturition) in parental male and female Han:WIST rats. The development of the F1 offspring was not impaired from birth to post-natal day 13 at any dose level after repeated oral administration of dams. Based on these observations the No Observed Adverse Effect Levels (NOAEL) were determined as follows: NOAEL for systemic toxicity of male/female rats: 1000 mg/kg bw/day NOAEL for reproductive performance of male/ female rats: 1000 mg/kg bw/day NOAEL for F1 Offspring: 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32f88f57-dd87-41b9-ad5c-06691f9951b2/documents/40da4c0a-b64a-468f-af70-4e44e6d35d9a_fdc0451e-fde9-4046-9ab5-2d2dd8d0b431.html,,,,,, "Phenol, 4-amino-, reaction products with aniline, 4-methyl-1,3-benzenediamine, p-phenylenediamine, sodium sulfide (Na2S) and sulfur",70892-38-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32f88f57-dd87-41b9-ad5c-06691f9951b2/documents/40da4c0a-b64a-468f-af70-4e44e6d35d9a_fdc0451e-fde9-4046-9ab5-2d2dd8d0b431.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Phenol, 4-amino-, reaction products with aniline, 4-methyl-1,3-benzenediamine, p-phenylenediamine, sodium sulfide (Na2S) and sulfur",70892-38-5," The acute oral LD50 was determined to be > 2000 mg dye/kg bw (corrected concentration, corresponding to > 3300 mg test item/kg bw). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32f88f57-dd87-41b9-ad5c-06691f9951b2/documents/fae207f5-35f4-4828-8564-c8b1b5c1bd30_fdc0451e-fde9-4046-9ab5-2d2dd8d0b431.html,,,,,, "Phenol, 4-amino-, reaction products with aniline, 4-methyl-1,3-benzenediamine, p-phenylenediamine, sodium sulfide (Na2S) and sulfur",70892-38-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32f88f57-dd87-41b9-ad5c-06691f9951b2/documents/fae207f5-35f4-4828-8564-c8b1b5c1bd30_fdc0451e-fde9-4046-9ab5-2d2dd8d0b431.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene",68610-51-5," Repeated dose toxicity of phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene was tested in two studies with male and female rats (oral feed), during 28 and 90 days. A NOAEL of 32 mg/kg bw/d was derived from the 90-day study based on increased activated partial thromboplastin time and increased liver weights in males. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bd0d7a9-e1d2-4521-996d-71719ebf86ac/documents/IUC5-4b7b9a05-8265-43c5-afba-e10ba3dc95fb_af4d8a70-1c93-4e71-ad36-72d6908c901c.html,,,,,, "Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene",68610-51-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bd0d7a9-e1d2-4521-996d-71719ebf86ac/documents/IUC5-4b7b9a05-8265-43c5-afba-e10ba3dc95fb_af4d8a70-1c93-4e71-ad36-72d6908c901c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,32 mg/kg bw/day,,rat "Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene",68610-51-5," Acute oral toxicity of  phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene was tested in two studies with (5 male and 5 female) rats, during 14 days. In addition, acute dermal toxicity of  phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene was tested in one study with (5 male and 5 female) rats, during 7 days.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bd0d7a9-e1d2-4521-996d-71719ebf86ac/documents/IUC5-c41ba50f-c9e0-4a61-8af3-aa8080b93cf3_af4d8a70-1c93-4e71-ad36-72d6908c901c.html,,,,,, "Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene",68610-51-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bd0d7a9-e1d2-4521-996d-71719ebf86ac/documents/IUC5-c41ba50f-c9e0-4a61-8af3-aa8080b93cf3_af4d8a70-1c93-4e71-ad36-72d6908c901c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene",68610-51-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bd0d7a9-e1d2-4521-996d-71719ebf86ac/documents/IUC5-c41ba50f-c9e0-4a61-8af3-aa8080b93cf3_af4d8a70-1c93-4e71-ad36-72d6908c901c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Phenol, 4-nonyl-, branched",84852-15-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a5368dc5-d41c-4b9d-b18c-878243e102f6/documents/84722be6-bf10-4418-97a6-1a9f2fe714d5_f84e1646-621c-42a5-9588-e1d956230a3a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "Phenol, 4-nonyl-, branched",84852-15-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5368dc5-d41c-4b9d-b18c-878243e102f6/documents/4c7c9a11-f832-4ba3-b94e-3aa211c80d12_f84e1646-621c-42a5-9588-e1d956230a3a.html,,oral,LD50,"1,246 mg/kg bw",, "Phenol, dodecyl-, branched",121158-58-5,"Oral:Based on the results of the 28 day key study, the no-observed-effect level (NOEL) for oral (gavage) administration of tetrapropenyl phenol to male rats for 28 consecutive days was less than 5 mg/kg/day due to a microscopic finding of follicular cell hypertrophy in the thyroid glands in one male from this group at the primary necropsy. For female rats, the NOEL was 20 mg/kg/day due to clinical observations noted at 60 mg/kg/day. Organ weight effects and microscopic findings in the adrenal gland were noted in males of the 20 mg/kg/day group and above. The microscopic findings in the thyroid and adrenal glands of the 300 mg/kg/day group did not persist to the recovery necropsy. Organ weight effects and microscopic findings in the liver were noted at 60 mg/kg/day and above and organ weights and/or microscopic findings in the reproductive organs (ovaries, seminal vesicles, prostate, coagulating glands, epididymides and/or testes) were noted at doses of 180 mg/kg/day and above. Because the organ weight and/or microscopic findings in the reproductive organs persisted to the recovery necropsy, the no-observed-adverse-effect level (NOAEL) was considered to be 60 mg/kg/day for males and females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d47d52a8-c592-467b-9e99-a3dc021d3950/documents/IUC5-dbc7319f-0d4c-44fd-a8a4-8bf808833d61_b591dfd4-7b97-424e-a47c-5458df5f3db2.html,,,,,, "Phenol, dodecyl-, branched",121158-58-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d47d52a8-c592-467b-9e99-a3dc021d3950/documents/IUC5-dbc7319f-0d4c-44fd-a8a4-8bf808833d61_b591dfd4-7b97-424e-a47c-5458df5f3db2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat "Phenol, dodecyl-, branched",121158-58-5,"Oral:The test material was administered by gavage to 6 groups of 5 (mix of M & F) Sprague-Dawley albino rats at doses of 1260, 1580, 2000, 2510, 3160 and 3980 mg/kg. A 14-d observation period followed administration. Calculation of an LD50 was done according to the method of E.J. de Beer.The calculated oral LD50 for dodecylphenol was 2100 mg/kg (95% confidence limits 1620-2730 mg/kg; slope 3.5). For the doses of 1260, 1580, 2000, 2510, 3160 and 3980 mg/kg, the number of deaths were 1, 2, 2, 4, 4 and 4, respectively, out of 5 animals per group. Clinical signs included weight loss (1 to 6 days in survivors), increasing weakness, diarrhea, collapse and death. Autopsy of decedents showed hemorrhagic lungs, areas of liver discoloration and gastrointestinal inflammation. Viscera of surviving animals appeared normal at sacrifice.Dermal:Three of six rabbits dosed at 15 grams per kilogram died within seven days. None of six animals dosed at 5 grams per kilogram died within a 14-day observation period. There was no incidence of gross pathology in survivors sacrificed 14 days after dosing.The test material, when administered to rabbits, had an acute dermal LD50 of approximately 15,000 mg/kg. Dermal irritation was evident in all animals. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d47d52a8-c592-467b-9e99-a3dc021d3950/documents/IUC5-e070b6ae-764a-48c6-addf-cad658cafeba_b591dfd4-7b97-424e-a47c-5458df5f3db2.html,,,,,, "Phenol, dodecyl-, branched",121158-58-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d47d52a8-c592-467b-9e99-a3dc021d3950/documents/IUC5-e070b6ae-764a-48c6-addf-cad658cafeba_b591dfd4-7b97-424e-a47c-5458df5f3db2.html,,oral,LD50,"2,100 mg/kg bw",, "Phenol, dodecyl-, branched",121158-58-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d47d52a8-c592-467b-9e99-a3dc021d3950/documents/IUC5-e070b6ae-764a-48c6-addf-cad658cafeba_b591dfd4-7b97-424e-a47c-5458df5f3db2.html,,dermal,LD50,"15,000 mg/kg bw",, "Phenol, dodecyl-, branched, sulfurized",96152-43-1,"Oral:Based upon the results of this study, the apparent NOAEL (no observable adverse effect level) for subacute toxicity & neurotoxicity was considered to be 200 mg/kg/day. This was then adjusted for presence of oil to relate to the Registration material, and the value adopted was 100mg/kg. Dermal:Repeated dermal applications of the test material caused no observable toxicity, with the exception of a slightly increased incidence and severity of skin irritation when compared to controls. The NOAEL for this study is considered to be >250 mg/kg b.wt./day males and female rats, highest dose tested. This is then adjusted to relate to the Registration material at 50% concentration, so the NOAEL value adopted is 125 mg/kg. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70ab67f3-d2cd-42c0-ae7a-6fe78d96d883/documents/a6d82014-c12f-4e7e-9b6f-c26a9bad6bf0_e3528aab-8422-4c9a-8d09-0738b4c52c5a.html,,,,,, "Phenol, dodecyl-, branched, sulfurized",96152-43-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70ab67f3-d2cd-42c0-ae7a-6fe78d96d883/documents/a6d82014-c12f-4e7e-9b6f-c26a9bad6bf0_e3528aab-8422-4c9a-8d09-0738b4c52c5a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Phenol, dodecyl-, branched, sulfurized",96152-43-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70ab67f3-d2cd-42c0-ae7a-6fe78d96d883/documents/a6d82014-c12f-4e7e-9b6f-c26a9bad6bf0_e3528aab-8422-4c9a-8d09-0738b4c52c5a.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,125 mg/kg bw/day,,rat "Phenol, dodecyl-, branched, sulfurized",96152-43-1,"Oral toxicity: The key read-across study and indeed all of the supporting information gave the same result. For this endpoint the LD50 is considered to be >5000 mg/kg. This result is applicable for the registration substance once it has been adjusted for the presence of oil, due to the structural similarities and category approach being used. The oil presence in the tested sample is 50%, hence the LD50 adopted for the registration material is 2500mg/kg. Dermal toxicity:In the key study for dermal exposure (Brorby, 1986; Report number: SOCAL 2327) there was no mention of what guideline was followed, however the methodology suggests that it was conducted similarly to OECD 402. The study was conducted in line with GLP. A reliability rating of 2 was applied for readacross, according to the criteria of Klimisch, 1997. This was considered the most reliable study. The acute dermal LD50 of the test material was considered to be >5 g/kg when administered as an 80% suspension in mineral oil (so the true tested sample LD50 >4 g/kg test material). The sample tested claims to be 100% pure (no oil) and this is presumably why it had to be diluted in mineral oil for administration. Hence this result can be used as is for the registration material. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70ab67f3-d2cd-42c0-ae7a-6fe78d96d883/documents/bdc9a415-95c3-4b1c-a8d8-65aa16efada8_e3528aab-8422-4c9a-8d09-0738b4c52c5a.html,,,,,, "Phenol, dodecyl-, branched, sulfurized",96152-43-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70ab67f3-d2cd-42c0-ae7a-6fe78d96d883/documents/bdc9a415-95c3-4b1c-a8d8-65aa16efada8_e3528aab-8422-4c9a-8d09-0738b4c52c5a.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "Phenol, dodecyl-, branched, sulfurized",96152-43-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70ab67f3-d2cd-42c0-ae7a-6fe78d96d883/documents/bdc9a415-95c3-4b1c-a8d8-65aa16efada8_e3528aab-8422-4c9a-8d09-0738b4c52c5a.html,,dermal,LD50,"4,000 mg/kg bw",no adverse effect observed, "Phenol, dodecyl-, branched, sulfurized",96152-43-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70ab67f3-d2cd-42c0-ae7a-6fe78d96d883/documents/bdc9a415-95c3-4b1c-a8d8-65aa16efada8_e3528aab-8422-4c9a-8d09-0738b4c52c5a.html,,inhalation,LC50,835 mg/m3,no adverse effect observed, "Phenol, ethoxylated",9004-78-8," The Acute Oral Toxicity of Phenol, ethoxylated (CAS 9004-78-8 / EC 500-013-6) was assessed based on the available information on its constituents. 2-phenoxyethanol has a Harmonised Classification as Acute Tox 4; H302, which was confirmed during the REACH Registration of the substance. 2-(2-phenoxyethoxy)ethanol was concluded not to meet the criteria for classification for this endpoint based on available experimental data on the substance. Considering the structural similarities between the constituents of Phenol, ethoxylated and in the absence of experimental data on the substance, 2-[2-(2-phenoxyethoxy)ethoxy]ethanol is not expected to be toxic following an acute exposure via the oral route. While it can be concluded according to the CLP Regulation that Phenol, ethoxylated does not meet the criteria for classification as toxic following an acute oral exposure, it is suggested to classify the substance as Acute Tox 4; H302 to compensate the lack of information on one of the constituents of the substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2872a8b6-cc97-4d57-85ec-8afcaeda0ef6/documents/89e0a0d6-81bd-4fec-8276-31f2cf2a63eb_0b162ff4-515c-4b41-95cd-0d9e1c8529da.html,,,,,, "Phenol, ethoxylated, esters with acrylic acid",56641-05-5," Wistar Han rats were treated with Phenol, ethoxylated, esters with acrylic acid by daily oral gavage at dose levels of 100, 300 and 1000 mg/kg/day in accordance with OECD 422. Based on the results of this combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the no-observed-adverse-effect levels (NOAEL) for parental toxicity was evaluated to be 300 mg/kg/day based on histopathological forestomach lesions in both sexes at 1000 mg/kg/day. No treatment-related changes were noted in any of the other parameters investigated in this study (i.e. clinical appearance, functional observations (motor activity, grip strength, hearing ability, pupillary reflex and static righting reflex), food consumption, clotting parameters and male T4 thyroid hormone levels). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb9eda1f-f3e0-4e7a-ae1d-a8322411b4b7/documents/b23cef7c-cd6f-4bf6-9886-433d031c09ba_2598f2c2-b02c-4f48-a266-5c366509ba6f.html,,,,,, "Phenol, ethoxylated, esters with acrylic acid",56641-05-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb9eda1f-f3e0-4e7a-ae1d-a8322411b4b7/documents/b23cef7c-cd6f-4bf6-9886-433d031c09ba_2598f2c2-b02c-4f48-a266-5c366509ba6f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Phenol, ethoxylated, esters with acrylic acid",56641-05-5, Data on the read-across substance 2-phenoxyethyl acrylate demonstrate a low acute oral and dermal toxicity. See attached read-across justification in section 13. No inhalation study is available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb9eda1f-f3e0-4e7a-ae1d-a8322411b4b7/documents/1a41de4d-35cf-4879-8404-d53f67dc41bc_2598f2c2-b02c-4f48-a266-5c366509ba6f.html,,,,,, "Phenol, ethoxylated, esters with acrylic acid",56641-05-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb9eda1f-f3e0-4e7a-ae1d-a8322411b4b7/documents/1a41de4d-35cf-4879-8404-d53f67dc41bc_2598f2c2-b02c-4f48-a266-5c366509ba6f.html,,oral,discriminating dose,"5,000 mg/kg bw",adverse effect observed, "Phenol, ethoxylated, esters with acrylic acid",56641-05-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb9eda1f-f3e0-4e7a-ae1d-a8322411b4b7/documents/1a41de4d-35cf-4879-8404-d53f67dc41bc_2598f2c2-b02c-4f48-a266-5c366509ba6f.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Phenol, heptyl derivs.",72624-02-3,"Toxicity of phenol, heptyl derivatives administered orally (gavage) to Crl:CD(SD) rats for 28 days was mainly observed at a dosage level of 450 mg/kg/day as evidenced by lethality, clinical observations (decreased defecation, dermal atonia, hypothermia), lower body weights, serum chemistry changes and several histologic changes (tubular nephropathy in the kidneys, fatty change of the liver, stratified squamous hyperplasia of the non-glandular stomach, thymic lymphoid depletion and hemorrhage and depletion of secretion of seminal vesicles). Therefore, the no-observed-adverse-effect level (NOAEL) for oral (gavage) administration of phenol, heptyl derivatives to Crl:CD(SD) rats for 28 consecutive days was 150 mg/kg/day as none of the aforementioned effects occurred at that dosage level.No classification for repeat dose effects is required as the effect is limited to a local irritant effect on the forestomach, which is not relevant to humans. The irritation effects observed at the 150 mg/kg/day dose level were not considered to be adverse. The systemic toxic effects observed at 450 mg/kg/day were considered to be secondary to the lcoal irritant effects in the stomach. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6358e35-a3b6-49f2-a481-daa3d51ef7fc/documents/IUC5-7bbb86e9-b712-463d-95e4-6aacb432f5d7_1ec15003-a437-421a-8a32-8ddb61d90734.html,,,,,, "Phenol, heptyl derivs.",72624-02-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6358e35-a3b6-49f2-a481-daa3d51ef7fc/documents/IUC5-7bbb86e9-b712-463d-95e4-6aacb432f5d7_1ec15003-a437-421a-8a32-8ddb61d90734.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Phenol, heptyl derivs.",72624-02-3,"In an acute oral toxicity study in the rat, the LD50 was determined to be in the range of 300 ‑ 2000 mg/kg bodyweight. No LD50 up to and including the maximum dose level (2000 mg/kg bw) could be derived for acute dermal exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6358e35-a3b6-49f2-a481-daa3d51ef7fc/documents/IUC5-d7ef6fa1-25b4-4aa5-bff1-24ddd42befff_1ec15003-a437-421a-8a32-8ddb61d90734.html,,,,,, "Phenol, heptyl derivs.",72624-02-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6358e35-a3b6-49f2-a481-daa3d51ef7fc/documents/IUC5-d7ef6fa1-25b4-4aa5-bff1-24ddd42befff_1ec15003-a437-421a-8a32-8ddb61d90734.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "Phenol, isopropylated",90480-88-9," CLP classification is available for the individual components of the substance via REACH Annex VI harmonised classifications, REACH Registration dossiers or notifications to the CLP inventory. As such, it is deemed inappropriate to conduct additional testing on the reaction mass subject to this registration when the results may be predicted on the basis of the components themselves. Acute oral toxicity is assessed in this manner. Please refer to Section 13 “Evaluation of Toxicity Endpoints” in addition for further information. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1dff2ec9-57c2-4693-aa3d-f5c61d780b68/documents/f981e0c8-c91d-4a38-801e-877e5860d2d6_8aef5f61-ae68-455c-bb03-df86593b9ca1.html,,,,,, "Phenol, isopropylated",90480-88-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1dff2ec9-57c2-4693-aa3d-f5c61d780b68/documents/f981e0c8-c91d-4a38-801e-877e5860d2d6_8aef5f61-ae68-455c-bb03-df86593b9ca1.html,,oral,LD50,230.41 mg/kg bw,adverse effect observed, "Phenol, isopropylated, phosphate (3:1)",68937-41-7, Subacute oral and dermal results and subchronic inhalation results are discussed. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8256e214-8879-4a28-99e3-72912feab4c7/documents/IUC5-a6bfcb49-4a59-4a26-b2e0-15d4671d4781_8e5d0fab-63d3-4615-aa6c-df001c01118e.html,,,,,, "Phenol, isopropylated, phosphate (3:1)",68937-41-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8256e214-8879-4a28-99e3-72912feab4c7/documents/IUC5-a6bfcb49-4a59-4a26-b2e0-15d4671d4781_8e5d0fab-63d3-4615-aa6c-df001c01118e.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,,rat "Phenol, isopropylated, phosphate (3:1)",68937-41-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8256e214-8879-4a28-99e3-72912feab4c7/documents/IUC5-a6bfcb49-4a59-4a26-b2e0-15d4671d4781_8e5d0fab-63d3-4615-aa6c-df001c01118e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,1.67 mg/kg bw/day,,rat "Phenol, isopropylated, phosphate (3:1)",68937-41-7," Oral, inhalation and dermal acute toxicity are all considered. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8256e214-8879-4a28-99e3-72912feab4c7/documents/IUC5-5bf3e1b7-a41e-4b05-a965-e90de94f2e16_8e5d0fab-63d3-4615-aa6c-df001c01118e.html,,,,,, "Phenol, isopropylated, phosphate (3:1)",68937-41-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8256e214-8879-4a28-99e3-72912feab4c7/documents/IUC5-5bf3e1b7-a41e-4b05-a965-e90de94f2e16_8e5d0fab-63d3-4615-aa6c-df001c01118e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Phenol, isopropylated, phosphate (3:1)",68937-41-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8256e214-8879-4a28-99e3-72912feab4c7/documents/IUC5-5bf3e1b7-a41e-4b05-a965-e90de94f2e16_8e5d0fab-63d3-4615-aa6c-df001c01118e.html,,dermal,LD50,"10,000 mg/kg bw",no adverse effect observed, "Phenol, isopropylated, phosphate (3:1)",68937-41-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8256e214-8879-4a28-99e3-72912feab4c7/documents/IUC5-5bf3e1b7-a41e-4b05-a965-e90de94f2e16_8e5d0fab-63d3-4615-aa6c-df001c01118e.html,,inhalation,LC50,200 mg/m3,no adverse effect observed, "Phenol, sulfonated",74665-14-8,NOAEL (male): 100 mg/kg bw/d NOAEL (female): 300 mg/kg bw/d ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/952943d8-ac1f-4e7c-ba52-1278634f9d7f/documents/baa1976f-8b6e-4533-bf1b-b57cf88a5ac6_cd8151af-746c-4ecc-8b6c-923395bf6081.html,,,,,, "Phenol, sulfonated",74665-14-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/952943d8-ac1f-4e7c-ba52-1278634f9d7f/documents/baa1976f-8b6e-4533-bf1b-b57cf88a5ac6_cd8151af-746c-4ecc-8b6c-923395bf6081.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Phenol, sulfonated",74665-14-8, LD50 oral = 1410 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/952943d8-ac1f-4e7c-ba52-1278634f9d7f/documents/2ae81179-c1d5-43cc-aacd-1c81470d731d_cd8151af-746c-4ecc-8b6c-923395bf6081.html,,,,,, "Phenol, sulfonated",74665-14-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/952943d8-ac1f-4e7c-ba52-1278634f9d7f/documents/2ae81179-c1d5-43cc-aacd-1c81470d731d_cd8151af-746c-4ecc-8b6c-923395bf6081.html,,oral,LD50,"1,410 mg/kg bw",adverse effect observed, "Phenol, sulfonated",74665-14-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/952943d8-ac1f-4e7c-ba52-1278634f9d7f/documents/2ae81179-c1d5-43cc-aacd-1c81470d731d_cd8151af-746c-4ecc-8b6c-923395bf6081.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "Phenol, sulfonated",74665-14-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/952943d8-ac1f-4e7c-ba52-1278634f9d7f/documents/2ae81179-c1d5-43cc-aacd-1c81470d731d_cd8151af-746c-4ecc-8b6c-923395bf6081.html,,inhalation,LC50,50 mg/m3,adverse effect observed, Phenoxymethylpenicillin potassium,132-98-9,"The most common reactions to oral penicillin in both animals and humans are gastrointestinal effects and hypersensitivity reactions. Gastrointestinal reactions are mild diarrhea, nausea or vomiting. The hypersensitivity reactions reported are skin eruptions (maculopapular to exfoliative dermatitis), urticaria and other serum-sicknesslike reactions, laryngeal edema, and anaphylaxis. Under the condition of the 28-days Reapeated dose toxcicty study, Pen V Potassium did not cause adverse systemic effects – clinical signs, changes in body weight, food consumption, hematologyand blood coagulation, clinical chemistry organ pathology or organ weights – in male or female Han:WIST rats after the consecutive 28-day oral (by gavage) administration of 100, 300 or 1000 mg/kg bw/day. Based on these observations, the No Observed Adverse Effect Level (NOAEL) was determined as 1000 mg/kg bw/day in male and female Han:WIST rats. Furthermore given the long history of safe use of penicillin in humans, the Repeated Dose 90-Day Oral Toxicity Study in Rodents (OECD TG 408)” are unlikely to add to the already known hazard profile of penicillin, and will result in the unnecessary use of animals. Chronic Toxicity: Two-year toxicology and carcinogenesis studies of penicillin VK were performed in F344/N rats and B6C3F1 mice. In these studies penicillin VK was administered for 2 years to rats and mice at doses of 0, 500, or 1000 mg/kg by oral gavage in corn oil. Toxic lesions of the stomach were seen in mice after penicillin VK administration. There was no evidence for carcinogenic activity in rats and mice after penicillin VK administration (Dunnick JK et al., 1987). Sub-chronic toxicity: Additionally, in a 13-week penicillin VK study, lesions of the forestomach were seen at levels of 1500 mg/kg in the rats and mice (Dunnick JK et al., 1989). ------------------------------------------------------------------------------------ Side/Adverse Effects- Incidence less frequent: Allergic reactions, specifically anaphylaxis (fast or irregular breathing; puffiness or swelling around face; shortness of breath; sudden, severe decrease in blood pressure), exfoliative dermatitis (red, scaly skin), serum sickness-like reactions (skin rash; joint pain, fever), skin rash, hives, or itching. Side/Adverse Effects -Incidence rare: Hepatotoxicity (fever, nausea and vomiting, yellow eyes or skin); interstitial nephritis (fever, possibly decreased urine output, skin rash); leukopenia or neutropenia (sore throat and fever); mental disturbances (anxiety, confusion, agitation or combativeness, depression, seizures, hallucinations, or expressed fear of impending death) pain at site of injection; platelet dysfunction or thrombocytopenia (unusual bleeding or bruising); Clostridium difficile colitis (severe abdominal or stomach cramps and pain; abdominal tenderness; watery and severe diarrhea, which may also be bloody; fever); seizures. Side/Adverse Effects- Incidence more frequent: Gastrointestinal reactions (mild diarrhea, nausea or vomiting); headache; oral candidiasis (sore mouth or tongue, white patches in mouth and/or on tongue); vaginal candidiasis (vaginal itching and discharge).   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2742ad6c-93dc-43aa-8b01-a8658114658e/documents/e8570acc-4e06-4396-9fb7-6d1bf92de222_b3d673e6-3db1-4f98-aa90-4676a700e86b.html,,,,,, Phenoxymethylpenicillin potassium,132-98-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2742ad6c-93dc-43aa-8b01-a8658114658e/documents/e8570acc-4e06-4396-9fb7-6d1bf92de222_b3d673e6-3db1-4f98-aa90-4676a700e86b.html,Chronic toxicity – systemic effects,oral,LOAEL,500 mg/kg bw/day,,mouse Phenoxymethylpenicillin potassium,132-98-9,"Penicillin V oral (Penicillin V potassium, Phenoxymethyl penicillin) and parenteral (Phenoxymethylpenicillin Benzathine) formulations are indicated in the treatment of mild to moderately severe infections due to penicillin sensitive microorganisms and have been widely used in human medicine for several decades having a well defined safety profile.  No relevant systemic toxic effects were noted in the acute inhalation toxicity studies. Penicillin V has low acute toxicity with oral LD50 > 4000 mg/kg in mouse and LD50 > 1040mg/kg in rat. Due to the long term use it is well established that penicillins have a minimal direct toxicity to animals and man, and toxic effects of non-allergic nature have only been observed after extremely high doses. At oral administration the target organ is gastrointestinal tract. Penicillin Vis generally well tolerated in humans but may occasionally cause transient nausea, diarrhoea and allergic reactions. It is well known that changes in the intestinal flora occur in all individuals treated orally with penicillin. The degree of alteration is related directly to the quantity administered. This effect is usually of no clinical significance and the normal microflora is re-established shortly after therapy is stopped. Safety after single administrationA large oral overdose of phenoxymethylpenicillin may cause nausea, vomiting, stomach pain, diarrhoea, and rarely, major motor seizures. If other symptoms are present, consider the possibility of an allergic reaction. Hyperkalaemia may result from overdose, particularly in patients with renal insufficiency (Sandoz, 2015). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2742ad6c-93dc-43aa-8b01-a8658114658e/documents/37001545-1748-42b0-9393-4a3121496bd1_b3d673e6-3db1-4f98-aa90-4676a700e86b.html,,,,,, Phenoxymethylpenicillin potassium,132-98-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2742ad6c-93dc-43aa-8b01-a8658114658e/documents/37001545-1748-42b0-9393-4a3121496bd1_b3d673e6-3db1-4f98-aa90-4676a700e86b.html,,oral,LD50,"1,040 mg/kg bw",adverse effect observed, Phenoxymethylpenicillin potassium,132-98-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2742ad6c-93dc-43aa-8b01-a8658114658e/documents/37001545-1748-42b0-9393-4a3121496bd1_b3d673e6-3db1-4f98-aa90-4676a700e86b.html,,inhalation,LC50,50.7 ,no adverse effect observed, Phenyl diamidophosphate,7450-69-3,Under the conditions of the acute oral toxicity study the median lethal dose of Phenyl diamidophosphate after oral administration was found to be greater than 300 mg/kg and less than 500 mg/kg body weight in rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0071214-a172-46d3-b80d-2c9b650dae8e/documents/IUC5-e873c49b-cf4c-4469-94e2-d037c827d62a_e53044e3-9b5c-4532-aa4b-ab65314cb022.html,,,,,, Phenyl diamidophosphate,7450-69-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d0071214-a172-46d3-b80d-2c9b650dae8e/documents/IUC5-e873c49b-cf4c-4469-94e2-d037c827d62a_e53044e3-9b5c-4532-aa4b-ab65314cb022.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Phenyl methacrylate,2177-70-0,"Oral LD50 (rate, female) = 500 mg/kg bw; OECD guideline 423; GLP ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/614c231a-bf56-41d8-89b3-b836c77065db/documents/IUC5-0a39d943-e274-47fc-a2eb-319b51dbad89_bf6c0374-8089-4e79-b9d6-384526a321c6.html,,,,,, Phenyl methacrylate,2177-70-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/614c231a-bf56-41d8-89b3-b836c77065db/documents/IUC5-0a39d943-e274-47fc-a2eb-319b51dbad89_bf6c0374-8089-4e79-b9d6-384526a321c6.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "Phenyl N-(4,6-dimethoxypyrimidin-2-yl)carbamate",89392-03-0,"In an acute oral toxicity study in rats according to EC method B.1, the LD50 was determined to be > 5000 mg/kg bw for males and females. The dermal toxicity study according to EC method B.2 on Wistar rats resulted in a LD50 of > 2000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d32114e-0ecc-4207-9321-ae2eb2035c89/documents/IUC5-40cefe90-30bd-4e64-94c3-a2d3e2ec834e_8e3187ff-1c4e-450a-8748-1c35df011f07.html,,,,,, "Phenyl N-(4,6-dimethoxypyrimidin-2-yl)carbamate",89392-03-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d32114e-0ecc-4207-9321-ae2eb2035c89/documents/IUC5-40cefe90-30bd-4e64-94c3-a2d3e2ec834e_8e3187ff-1c4e-450a-8748-1c35df011f07.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Phenyl N-(4,6-dimethoxypyrimidin-2-yl)carbamate",89392-03-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d32114e-0ecc-4207-9321-ae2eb2035c89/documents/IUC5-40cefe90-30bd-4e64-94c3-a2d3e2ec834e_8e3187ff-1c4e-450a-8748-1c35df011f07.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, phenyl pent-4-enoate,51231-09-5," Oral: NOAEL (rat): 150 mg/kg bw/day ; male/female, OECD TG 407, 2017 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a167c784-9080-44ed-99d6-b48a9158fb08/documents/1a16ef1d-4a58-4fef-99e4-699c72a57f1f_2210d041-dbf5-487c-91fa-8be6351e1374.html,,,,,, phenyl pent-4-enoate,51231-09-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a167c784-9080-44ed-99d6-b48a9158fb08/documents/1a16ef1d-4a58-4fef-99e4-699c72a57f1f_2210d041-dbf5-487c-91fa-8be6351e1374.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat phenyl pent-4-enoate,51231-09-5," Oral: LD50 > 300 - < 2000 mg/kg bw, female rat, OECD TG 420, 2016 Inhalation: LC50 (female): 2.72 (C.I. 1.88 – 3.55) mg/L, OECD TG 403, 2016 Dermal: measured LD50 > 2000 mg/kg bw and the estimated LD50 cut-off value was considered to be > 5000 mg/kg bw, male/female rat, OECD TG 402, 2016 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a167c784-9080-44ed-99d6-b48a9158fb08/documents/IUC5-5b9cb8d2-b542-4daf-95a9-fe882cc7b84a_2210d041-dbf5-487c-91fa-8be6351e1374.html,,,,,, phenyl pent-4-enoate,51231-09-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a167c784-9080-44ed-99d6-b48a9158fb08/documents/IUC5-5b9cb8d2-b542-4daf-95a9-fe882cc7b84a_2210d041-dbf5-487c-91fa-8be6351e1374.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, phenyl pent-4-enoate,51231-09-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a167c784-9080-44ed-99d6-b48a9158fb08/documents/IUC5-5b9cb8d2-b542-4daf-95a9-fe882cc7b84a_2210d041-dbf5-487c-91fa-8be6351e1374.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, phenyl pent-4-enoate,51231-09-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a167c784-9080-44ed-99d6-b48a9158fb08/documents/IUC5-5b9cb8d2-b542-4daf-95a9-fe882cc7b84a_2210d041-dbf5-487c-91fa-8be6351e1374.html,,inhalation,LC50,"2,720 mg/m3",adverse effect observed, Phenylhydrazine,100-63-0,"Exposure to phenylhydrazine may cause damage to red blood cells, potentially resulting in anaemia and consequential secondary involvement of other tissues, such as the spleen and liver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19c2ed85-8e23-4dc1-bbb7-8e32d3606d75/documents/IUC5-e129927a-9772-4d5f-a21a-a0645805c550_e362f138-d05e-4a1d-8551-2132fa14f47b.html,,,,,, Phenylhydrazine,100-63-0,"Data on the acute toxicity of phenylhydrazine was available, including oral, dermal and inhalative acute toxicity data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19c2ed85-8e23-4dc1-bbb7-8e32d3606d75/documents/IUC5-0a4a5ef3-ce2b-415f-a669-7031e136ad84_e362f138-d05e-4a1d-8551-2132fa14f47b.html,,,,,, Phenylhydrazine,100-63-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19c2ed85-8e23-4dc1-bbb7-8e32d3606d75/documents/IUC5-0a4a5ef3-ce2b-415f-a669-7031e136ad84_e362f138-d05e-4a1d-8551-2132fa14f47b.html,,oral,LD50,80 mg/kg bw,, Phenylhydrazine,100-63-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19c2ed85-8e23-4dc1-bbb7-8e32d3606d75/documents/IUC5-0a4a5ef3-ce2b-415f-a669-7031e136ad84_e362f138-d05e-4a1d-8551-2132fa14f47b.html,,dermal,LD50,380 mg/kg bw,, Phenylhydrazine,100-63-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19c2ed85-8e23-4dc1-bbb7-8e32d3606d75/documents/IUC5-0a4a5ef3-ce2b-415f-a669-7031e136ad84_e362f138-d05e-4a1d-8551-2132fa14f47b.html,,inhalation,LC50,"2,093 mg/m3",, Phenytoin,57-41-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): LD50 oral rat= 1635 mg/kg LD50 oral mouse=150 mg/kg ChemID's data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/331cc48b-760a-4c8e-9f91-053e8abc112a/documents/1930cc0c-032f-4408-aa92-6dba249f3b6d_bc9f29a2-9fb8-478f-b1ce-408f7445ec08.html,,,,,, Phenytoin,57-41-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/331cc48b-760a-4c8e-9f91-053e8abc112a/documents/1930cc0c-032f-4408-aa92-6dba249f3b6d_bc9f29a2-9fb8-478f-b1ce-408f7445ec08.html,,oral,LD50,"1,635 mg/kg bw",, Phenytoin sodium,630-93-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): LD50 oral rat= 1530 mg/kg LD50 oral mouse= 165 mg/kg ChemID's data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90959686-803e-4bcb-b4d7-8641ba28ff4b/documents/d87ddd5a-1487-4d3f-a47f-9183a03374a9_570fb9ae-81c8-44b6-ba9c-ec9830ac28fd.html,,,,,, Phenytoin sodium,630-93-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90959686-803e-4bcb-b4d7-8641ba28ff4b/documents/d87ddd5a-1487-4d3f-a47f-9183a03374a9_570fb9ae-81c8-44b6-ba9c-ec9830ac28fd.html,,oral,LD50,"1,530 mg/kg bw",, Phosgene,75-44-5,No guideline study on repeated dose toxicity is available for phosgene. Data waiver is claimed ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/84f6d47f-a931-4355-a893-6cc03ac5e554/documents/IUC5-f043d27b-8b48-4210-a9a1-e5841561f811_952a288d-5dbd-44d9-bb2d-5226cdf0c802.html,,,,,, Phosgene,75-44-5,Phosgene is very toxic by inhalation. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84f6d47f-a931-4355-a893-6cc03ac5e554/documents/IUC5-7bbbdaf9-693a-43ba-abe6-5e55b38c6e41_952a288d-5dbd-44d9-bb2d-5226cdf0c802.html,,,,,, Phosgene,75-44-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84f6d47f-a931-4355-a893-6cc03ac5e554/documents/IUC5-7bbbdaf9-693a-43ba-abe6-5e55b38c6e41_952a288d-5dbd-44d9-bb2d-5226cdf0c802.html,,inhalation,LC50,8.6 mg/m3,adverse effect observed, "Phosphinic acid, diethyl-, sodium salt",35160-38-4,"Study: Repeated Dose (28 Days) Oral Toxicity Study of Diethyl Phosphinic Acid Sodium Salt (DEPNa) in Wistar Rats with 14 Day Recovery Period Test Guideline followed: OECD Guidelines for Testing of Chemicals, No. 407 entitled “Repeated Dose 28-Day Oral Toxicity Study in Rodents, 3rdOctober 2008”. Species: Wistar Rats Duration of treatment: 28 consecutive days Route of administration: Oral NOAEL: 1000 mg/kg body weight Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): this study was conducted in compliance with the Organization of Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice (GLP) ENV/MC/CHEM(98)17 and in accordance with the approved Study Plan and following all relevant SOPs. All the documents pertaining to the study, including raw data, specimens, materials, slides, original study plan, amendment and final study report will be retained at the Archives of the test institute. The objectives laid down in the study plan were achieved. No unforeseen circumstances which might have affected the quality or integrity of the study were observed. This report is a complete, true and accurate representation of the study and its results. The Test Facility Management has made available all the resources to the Study Director necessary for the conduct of the present study in compliance with the study plan agreed between Study Director and the Sponsor. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a080236-a316-44f3-8add-4fdbeb000324/documents/448e21d1-0331-4126-a72e-688d2593b84b_83128c30-d4ef-4153-82e7-66cf6246be6b.html,,,,,, "Phosphinic acid, diethyl-, sodium salt",35160-38-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a080236-a316-44f3-8add-4fdbeb000324/documents/448e21d1-0331-4126-a72e-688d2593b84b_83128c30-d4ef-4153-82e7-66cf6246be6b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Phosphinic acid, diethyl-, sodium salt",35160-38-4,"Acute Oral Rat; OECD 423 Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Fully GLP compliant study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a080236-a316-44f3-8add-4fdbeb000324/documents/fd3653a6-ba38-4e23-bf27-c781c89cc8e6_83128c30-d4ef-4153-82e7-66cf6246be6b.html,,,,,, "Phosphinic acid, diethyl-, sodium salt",35160-38-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a080236-a316-44f3-8add-4fdbeb000324/documents/fd3653a6-ba38-4e23-bf27-c781c89cc8e6_83128c30-d4ef-4153-82e7-66cf6246be6b.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Phosphine,7803-51-2, Newton et al. found a chronic NOAEC for rats at 3 ppm (4.3 mg/m3) (1999) and a subchronic NOAEC for rat at 3.1 ppm (4.4 mg/m3) (1993). Barbosa et al. (1994) found a subchronic NOAEC for mice at 1 ppm. These results indicated that mice may be more sensitive than rats. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a846678e-df97-4fa3-b646-1649b13bd38d/documents/27c9c9b7-0c7e-4a5b-a3ea-cf1c848930d2_49bc1fd1-a8fb-45fd-9ebf-8bb89649e721.html,,,,,, Phosphine,7803-51-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a846678e-df97-4fa3-b646-1649b13bd38d/documents/27c9c9b7-0c7e-4a5b-a3ea-cf1c848930d2_49bc1fd1-a8fb-45fd-9ebf-8bb89649e721.html,Chronic toxicity – systemic effects,inhalation,NOAEC,4.3 mg/m3,,rat Phosphine,7803-51-2," The acute inhalation of phosphine is high. Four-hour LC50 value between 26.5 ppm (37.5 mg/m3) and 33.4 ppm (47.3 mg/m3), for mice, has been reported (Omae et al., 1996). For rat, different LC50 values have been reported: 28 ppm (39.7 mg/m3)/5.2 hours (Newton et al., 1993) and 11 ppm (15.6 mg/m3)/ 4 hours (Waritz and Brown, 1975). Early symptoms of acute phosphine exposure include respiratory problems, dizziness, general fatigue and gastrointestinal disturbance.The effects on mice and on rat seem to be equivalent. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a846678e-df97-4fa3-b646-1649b13bd38d/documents/e2b392b5-063b-4eef-8b52-0585f84e1a3a_49bc1fd1-a8fb-45fd-9ebf-8bb89649e721.html,,,,,, Phosphine,7803-51-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a846678e-df97-4fa3-b646-1649b13bd38d/documents/e2b392b5-063b-4eef-8b52-0585f84e1a3a_49bc1fd1-a8fb-45fd-9ebf-8bb89649e721.html,,inhalation,LC50,37.5 mg/m3,adverse effect observed, Phosphinic acid,6303-21-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The potential toxicity of sodium phosphinate following repeated administration was investigated according to OECD guideline 422 and EPA guideline OPPTS 870.3650. As phosphinic acid is generated from sodium phosphinate, toxicity for the two substance are considered as similar. Phosphinic acid is of low toxicity by repeated administration: The NOAEL was established to 1080 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3817d135-cec6-43c7-9122-b51726914862/documents/IUC5-bea64ef4-68d3-4375-ab0d-09471f5f5753_eaeb4eb8-6589-4b29-b41d-c30893e1f810.html,,,,,, Phosphinic acid,6303-21-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3817d135-cec6-43c7-9122-b51726914862/documents/IUC5-bea64ef4-68d3-4375-ab0d-09471f5f5753_eaeb4eb8-6589-4b29-b41d-c30893e1f810.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,080 mg/kg bw/day",,rat Phosphinic acid,6303-21-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The potential toxicity of sodium phosphinate following a single oral administration in rats was investigated according to OECD guideline 401 and methods similar to OPPTS 870.1100. As phosphinic acid is generated from sodium phosphinate, toxicity for the two substance are considered as similar. Phosphinic acid is of low toxicity by oral administration. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3817d135-cec6-43c7-9122-b51726914862/documents/IUC5-4e7def52-d9f2-46d4-9451-b4f5e23cb807_eaeb4eb8-6589-4b29-b41d-c30893e1f810.html,,,,,, Phosphinic acid,6303-21-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3817d135-cec6-43c7-9122-b51726914862/documents/IUC5-4e7def52-d9f2-46d4-9451-b4f5e23cb807_eaeb4eb8-6589-4b29-b41d-c30893e1f810.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, aluminum;phosphenous acid,7784-22-7, Oral route: for Al(H2PO2)3: NOAEL males(28 d) > 86.9 mg/l; female NOAEL (28d): 35.2 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5416cab2-4fa2-4215-ad14-d3d578cb01c0/documents/IUC5-2773efc8-a300-40f5-b587-a68ad12fb340_eaf7b7cd-d6cb-4405-adaf-025685a796aa.html,,,,,, aluminum;phosphenous acid,7784-22-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5416cab2-4fa2-4215-ad14-d3d578cb01c0/documents/IUC5-2773efc8-a300-40f5-b587-a68ad12fb340_eaf7b7cd-d6cb-4405-adaf-025685a796aa.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,35.2 mg/kg bw/day,,rat aluminum;phosphenous acid,7784-22-7, Oral route: LD50 > 2000 mg/kg bw Inhalation route: LC50 (4 h) > 3.30 mg/L Dermal route: LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5416cab2-4fa2-4215-ad14-d3d578cb01c0/documents/IUC5-79ca76d7-088e-476d-a662-110b89eb4a81_eaf7b7cd-d6cb-4405-adaf-025685a796aa.html,,,,,, aluminum;phosphenous acid,7784-22-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5416cab2-4fa2-4215-ad14-d3d578cb01c0/documents/IUC5-79ca76d7-088e-476d-a662-110b89eb4a81_eaf7b7cd-d6cb-4405-adaf-025685a796aa.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, aluminum;phosphenous acid,7784-22-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5416cab2-4fa2-4215-ad14-d3d578cb01c0/documents/IUC5-79ca76d7-088e-476d-a662-110b89eb4a81_eaf7b7cd-d6cb-4405-adaf-025685a796aa.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, aluminum;phosphenous acid,7784-22-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5416cab2-4fa2-4215-ad14-d3d578cb01c0/documents/IUC5-79ca76d7-088e-476d-a662-110b89eb4a81_eaf7b7cd-d6cb-4405-adaf-025685a796aa.html,,inhalation,LC50,"3,300 mg/m3",no adverse effect observed, Phosphinylidynetrimethanol,1067-12-5," - Based on the available Reproduction/Development Toxicity Screening study following repeated daily administration by oral gavage to Wistar rats (OECD 422, GLP) it can be concluded that Tris(hydroxymethyl)phosphine oxide (THPO) does not produce adverse systemic toxicity effects relevant for hazard assessment at dose levels up to 1000 mg/kg bw/day (NOAEL). - The NOAEL for systemic, and reproductive and developmental toxicity is 1000 mg/kg/day under the conditions of this study, ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1573c8af-70f3-40df-9495-56f37de165f9/documents/dc5b82aa-e4d3-4ab4-8c2f-52f164fa2317_0fb98915-2046-4589-9f9e-da682e68fd6e.html,,,,,, Phosphinylidynetrimethanol,1067-12-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1573c8af-70f3-40df-9495-56f37de165f9/documents/dc5b82aa-e4d3-4ab4-8c2f-52f164fa2317_0fb98915-2046-4589-9f9e-da682e68fd6e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Phosphinylidynetrimethanol,1067-12-5," - Acute oral toxicity [OECD 423, acute toxic class method; GLP]: LD50 in female rats >2000 mg/kg bw. - Acute inhalation toxicity: Taking into account the very low vapour pressure of the registration substance, exposure via the inhalation route is unlikely; it is therefore considered justified to omit this endpoint information. - Acute dermal toxicity: The physicochemical and toxicological properties of the registration substance suggest no potential for a significant rate of absorption through the skin; it is therefore considered justified to omit this endpoint information. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1573c8af-70f3-40df-9495-56f37de165f9/documents/dc19fe38-0d1d-4b60-bf8d-b72e46ec7a93_0fb98915-2046-4589-9f9e-da682e68fd6e.html,,,,,, Phosphinylidynetrimethanol,1067-12-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1573c8af-70f3-40df-9495-56f37de165f9/documents/dc19fe38-0d1d-4b60-bf8d-b72e46ec7a93_0fb98915-2046-4589-9f9e-da682e68fd6e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Phosphonic acid,13598-36-2,28-day oral + reproduction/developmental toxicity screening (rat): NOAEL 250 mg/kg bw/day (OECD 422) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/916b4d2a-41bd-462f-9629-9e33672b4155/documents/IUC5-9785e1c4-ea87-4a76-bb87-33cb371b58b8_51b93324-e623-4249-93f8-c96827d7d609.html,,,,,, Phosphonic acid,13598-36-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/916b4d2a-41bd-462f-9629-9e33672b4155/documents/IUC5-9785e1c4-ea87-4a76-bb87-33cb371b58b8_51b93324-e623-4249-93f8-c96827d7d609.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Phosphonic acid,13598-36-2,Acute oral toxicity: LD50 1580 mg/kg bw for males and 1560 mg/kg bw for females ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/916b4d2a-41bd-462f-9629-9e33672b4155/documents/IUC5-4a97c64a-98fd-40ee-b386-1f46927a9b5c_51b93324-e623-4249-93f8-c96827d7d609.html,,,,,, Phosphonic acid,13598-36-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/916b4d2a-41bd-462f-9629-9e33672b4155/documents/IUC5-4a97c64a-98fd-40ee-b386-1f46927a9b5c_51b93324-e623-4249-93f8-c96827d7d609.html,,oral,LD50,"1,560 mg/kg bw",adverse effect observed, "Phosphonic acid, calcium salt (2:1)",13780-04-6, NOEL oral rat subacute ≥ 841 mg Ca(H2PO3)2 /kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ac7c66f-d884-4a26-ac09-df35fee11e02/documents/1da78f5a-2e91-451b-b062-6110d624cf25_66e72724-9cce-43b3-9816-c737026f40aa.html,,,,,, "Phosphonic acid, calcium salt (2:1)",13780-04-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ac7c66f-d884-4a26-ac09-df35fee11e02/documents/1da78f5a-2e91-451b-b062-6110d624cf25_66e72724-9cce-43b3-9816-c737026f40aa.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,841 mg/kg bw/day,,rat "Phosphonic acid, calcium salt (2:1)",13780-04-6, LD50 Acute Oral rat > 1683 mg Ca(H2PO3)2 /kg bw LD50 Acute Dermal rat > 4206 mg Ca(H2PO3)2 /kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ac7c66f-d884-4a26-ac09-df35fee11e02/documents/71ed3906-5c01-4677-804f-6e20846cfe37_66e72724-9cce-43b3-9816-c737026f40aa.html,,,,,, "Phosphonic acid, calcium salt (2:1)",13780-04-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ac7c66f-d884-4a26-ac09-df35fee11e02/documents/71ed3906-5c01-4677-804f-6e20846cfe37_66e72724-9cce-43b3-9816-c737026f40aa.html,,oral,LD50,"1,683 mg/kg bw",no adverse effect observed, "Phosphonic acid, calcium salt (2:1)",13780-04-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ac7c66f-d884-4a26-ac09-df35fee11e02/documents/71ed3906-5c01-4677-804f-6e20846cfe37_66e72724-9cce-43b3-9816-c737026f40aa.html,,dermal,LD50,"4,206 mg/kg bw",no adverse effect observed, "Phosphonic acid, diammonium salt, monohydrate",51503-61-8, NOEL oral rat subacute > 1000 mg/Kg bw ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5d6df1d-5373-48b2-9906-5280a682c979/documents/fc443f5e-08b7-4817-b5d8-a7872c4a201c_50839ee1-667b-40e2-8721-67bb5ad9202e.html,,,,,, "Phosphonic acid, diammonium salt, monohydrate",51503-61-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5d6df1d-5373-48b2-9906-5280a682c979/documents/fc443f5e-08b7-4817-b5d8-a7872c4a201c_50839ee1-667b-40e2-8721-67bb5ad9202e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Phosphonic acid, diammonium salt, monohydrate",51503-61-8, LD50 Acute Oral rat > 2000 mg/Kg bw LD50 Acute Dermal rat > 5000 mg/Kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5d6df1d-5373-48b2-9906-5280a682c979/documents/325b0364-0ccc-4dba-a0bd-1d40425e1b1b_50839ee1-667b-40e2-8721-67bb5ad9202e.html,,,,,, "Phosphonic acid, diammonium salt, monohydrate",51503-61-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5d6df1d-5373-48b2-9906-5280a682c979/documents/325b0364-0ccc-4dba-a0bd-1d40425e1b1b_50839ee1-667b-40e2-8721-67bb5ad9202e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Phosphonic acid, diammonium salt, monohydrate",51503-61-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5d6df1d-5373-48b2-9906-5280a682c979/documents/325b0364-0ccc-4dba-a0bd-1d40425e1b1b_50839ee1-667b-40e2-8721-67bb5ad9202e.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Phosphonic acid, magnesium salt (2:1)",13598-61-3, NOEL oral rat subacute ≥ 776 mg Mg(H2PO3)2 /kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cca2370f-aa2e-4e75-8d82-422cdfef2b25/documents/e2b1588b-7d79-4640-8cbc-a50a802b53b0_f94d1e44-e74e-48ea-ad63-e42c95f1ddc7.html,,,,,, "Phosphonic acid, magnesium salt (2:1)",13598-61-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cca2370f-aa2e-4e75-8d82-422cdfef2b25/documents/e2b1588b-7d79-4640-8cbc-a50a802b53b0_f94d1e44-e74e-48ea-ad63-e42c95f1ddc7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,776 mg/kg bw/day,,rat "Phosphonic acid, magnesium salt (2:1)",13598-61-3, LD50 Acute Oral rat > 1551 mg Mg(H2PO3)2 /kg bw LD50 Acute Dermal rat > 3878 mg Mg(H2PO3)2 /kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cca2370f-aa2e-4e75-8d82-422cdfef2b25/documents/f50204e3-7162-4430-8305-4c155748b8ef_f94d1e44-e74e-48ea-ad63-e42c95f1ddc7.html,,,,,, "Phosphonic acid, magnesium salt (2:1)",13598-61-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cca2370f-aa2e-4e75-8d82-422cdfef2b25/documents/f50204e3-7162-4430-8305-4c155748b8ef_f94d1e44-e74e-48ea-ad63-e42c95f1ddc7.html,,oral,LD50,"1,551 mg/kg bw",no adverse effect observed, "Phosphonic acid, magnesium salt (2:1)",13598-61-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cca2370f-aa2e-4e75-8d82-422cdfef2b25/documents/f50204e3-7162-4430-8305-4c155748b8ef_f94d1e44-e74e-48ea-ad63-e42c95f1ddc7.html,,dermal,LD50,"3,878 mg/kg bw",no adverse effect observed, "Phosphonic acid, mixed C12-20-alkyl and C14-18-unsatd. alkyl derivs.",93925-25-8," Not subacute toxic, evidenced up to the limit test value recommended by guidance, i.e. 1000 mg/kg bw per d, sub-chronic effects unlikely, inhalation and dermal routes irrelevant, baseline toxicity assumed ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c77297c7-c946-453d-9346-8bcf67247ff1/documents/IUC5-5b5e8535-47e7-4bd0-9842-8fbedfedf6e2_8d9dc018-736a-487d-a507-c71e09e02a65.html,,,,,, "Phosphonic acid, mixed C12-20-alkyl and C14-18-unsatd. alkyl derivs.",93925-25-8,"Not acute toxic, no differences to control ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c77297c7-c946-453d-9346-8bcf67247ff1/documents/IUC5-bdd05a94-aafb-4eec-b3a5-0a96c9fbf439_8d9dc018-736a-487d-a507-c71e09e02a65.html,,,,,, Reaction product of 3-Chloropropyltrimethoyxsilane and triethyl phosphite,1079258-99-3,"LD50(oral, rat) > 2000 mg/kg (BASF, 2015) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc937e22-164a-4ef7-8a94-3ded2e57ba5e/documents/IUC5-3ce742c0-dd01-43de-8938-d654c498c355_fb6d412e-2944-47b5-a485-c9e72c7d5706.html,,,,,, Diethyl allylphosphonate,1067-87-4,"In an acute oral study according to the fixed dose method, a single female rat dosed with the substance at 2000 mg/kg bw by gavage was terminated for humane reasons within 30 minutes after dosing. 5 females dosed with the substance at 300 mg/kg bw did not exhibit mortality, significant clinical signs, effect on body weight or gross pathology. Therefore the LD50 of the substance is between 300 and 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/506eb8ae-3661-4b3e-8d14-c660ffb399f8/documents/IUC5-509c86d3-ea0b-4781-9833-1d61695ec653_166164f5-b039-4f28-8b73-e20013f18eee.html,,,,,, Diethyl allylphosphonate,1067-87-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/506eb8ae-3661-4b3e-8d14-c660ffb399f8/documents/IUC5-509c86d3-ea0b-4781-9833-1d61695ec653_166164f5-b039-4f28-8b73-e20013f18eee.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "Phosphonic acid, potassium salt (1:1)",13977-65-6,NOEL oral rat subacute > 1000 mg/Kg bw ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4c421e9-f182-4599-88f6-f35421a1eb60/documents/IUC5-fdb1c921-cd0d-4789-91a5-943969a52a1f_74648653-4f02-4ac9-a2b5-5121fd758193.html,,,,,, "Phosphonic acid, potassium salt (1:1)",13977-65-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4c421e9-f182-4599-88f6-f35421a1eb60/documents/IUC5-fdb1c921-cd0d-4789-91a5-943969a52a1f_74648653-4f02-4ac9-a2b5-5121fd758193.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Phosphonic acid, potassium salt (1:1)",13977-65-6,LD50 Acute Oral rat > 2000 mg/Kg bwLD50 Acute Dermal rat > 5000 mg/Kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4c421e9-f182-4599-88f6-f35421a1eb60/documents/IUC5-3b9c5598-9705-4f41-a94b-8dd0fb64dcab_74648653-4f02-4ac9-a2b5-5121fd758193.html,,,,,, "Phosphonic acid, potassium salt (1:1)",13977-65-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4c421e9-f182-4599-88f6-f35421a1eb60/documents/IUC5-3b9c5598-9705-4f41-a94b-8dd0fb64dcab_74648653-4f02-4ac9-a2b5-5121fd758193.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Phosphonic acid, potassium salt (1:1)",13977-65-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4c421e9-f182-4599-88f6-f35421a1eb60/documents/IUC5-3b9c5598-9705-4f41-a94b-8dd0fb64dcab_74648653-4f02-4ac9-a2b5-5121fd758193.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, 4-(4-hydroxybenzenesulfonyl)phenol bis(tetraphenylphosphanium) bis(4-(4-hydroxybenzenesulfonyl)benzen-1-olate),502157-74-6,"The acute oral median lethal dose (LD50) of the test material in the femaleSprague-Dawley CD strain rat was estimated to be in the range of 300 - 500 mg/kg bodyweight. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): K1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe00885b-8e52-43f7-9500-f8278ab355a2/documents/beea126b-fbe2-4786-b8f7-5feb8771ba79_f36a70c5-9c13-4de3-b512-1fca2c82143a.html,,,,,, 4-(4-hydroxybenzenesulfonyl)phenol bis(tetraphenylphosphanium) bis(4-(4-hydroxybenzenesulfonyl)benzen-1-olate),502157-74-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe00885b-8e52-43f7-9500-f8278ab355a2/documents/beea126b-fbe2-4786-b8f7-5feb8771ba79_f36a70c5-9c13-4de3-b512-1fca2c82143a.html,,oral,LD50,>=300 mg/kg bw,adverse effect observed, trihexyl(tetradecyl)phosphonium;chloride,258864-54-9, The acute oral test available on Trihexyltetradecylphosphonium chloride (CAS no 258864-54-9) indicates GHS classification as acute oral toxicity category 4 (LD50 between 300 and 2000 mg/kg). The oral LD50 study on Trihexyltetradecylphosphonium chloride (CAS no 258864-54-9) was performed according to OECD Guideline 423 and conformed with GLP requirements. This study was considered reliable without restrictions (Klimisch 1). The acute dermal test available on Trihexyltetradecylphosphonium chloride (CAS no 258864-54-9) indicates a classification as not classified (LD50 > 2000 mg/kg). The dermal LD50 study on Trihexyltetradecylphosphonium chloride (CAS no 258864-54-9) was performed according to OECD Guideline 402 and conformed with GLP requirements. This study was considered reliable without restrictions (Klimisch 1). No data is available on acute toxicity via inhalation route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/196569dd-38fb-43fc-83c1-f429ba364540/documents/91564999-3d0f-478c-9048-b1d8487b7003_721b8320-2305-4749-83ae-4f9c6f7d060c.html,,,,,, "Phosphonium, triphenyl(3,7,11-trimethyl-2,4,6,10-dodecatetraenyl)-",131560-11-7," In an OECD 423 acute oral toxicity study in rats, the LD 50 was found to be greater than 200 mg/kg bw and less or equal to 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b95f4e4b-7159-405a-9b78-286e9f488a68/documents/a4832aad-b898-4280-90c3-13644472fcf4_ab3ff8cd-a74a-4fe4-9165-35d8bfb256e3.html,,,,,, "Phosphonium, triphenyl(3,7,11-trimethyl-2,4,6,10-dodecatetraenyl)-",131560-11-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b95f4e4b-7159-405a-9b78-286e9f488a68/documents/a4832aad-b898-4280-90c3-13644472fcf4_ab3ff8cd-a74a-4fe4-9165-35d8bfb256e3.html,,oral,LD50,200 mg/kg bw,adverse effect observed, "Phosphoric acid, 2-ethylhexyl ester",12645-31-7,"NOAEL = 250 mg/kg bw/d; Dunster & Watson (2012); OECD 422 (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening test)NOAEL = 250 mg/kg bw/d; Astill, D.D. et al. (1996); OECD 408 (Repeated Dose 90-Day Oral Toxicity in Rodents) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01e064ca-bd8a-4b55-a836-753c1a437dfc/documents/IUC5-0ef295f6-07eb-48b5-ad5b-18ad65fcfec4_5b67b547-9140-4bee-a3bf-eaf9bd0de9e8.html,,,,,, "Phosphoric acid, 2-ethylhexyl ester",12645-31-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01e064ca-bd8a-4b55-a836-753c1a437dfc/documents/IUC5-0ef295f6-07eb-48b5-ad5b-18ad65fcfec4_5b67b547-9140-4bee-a3bf-eaf9bd0de9e8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Phosphoric acid, 2-ethylhexyl ester",12645-31-7,The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was approximately 2500 mg/kg bodyweight Acute dermal and acute inhalation studies were not conducted as the substance is classified as corrosive. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01e064ca-bd8a-4b55-a836-753c1a437dfc/documents/IUC5-06e8c207-4314-42d9-9293-6a8b44f5b90f_5b67b547-9140-4bee-a3bf-eaf9bd0de9e8.html,,,,,, "Phosphoric acid, 2-ethylhexyl ester",12645-31-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01e064ca-bd8a-4b55-a836-753c1a437dfc/documents/IUC5-06e8c207-4314-42d9-9293-6a8b44f5b90f_5b67b547-9140-4bee-a3bf-eaf9bd0de9e8.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, "Phosphoric acid, 2-ethylhexyl ester, ammonium salt",86014-62-2," NOAEL systemic = > 250 mg/kg bw/day Female and => 125 mg/kg bw/day male rat; OECD 422; Anon., 2012 (read across from Reaction mass of bis(2-ethylhexyl) hydrogen phosphate and 2-ethylhexyl dihydrogen phosphate) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd0f38cb-b591-450d-8e78-2c45fdfb3ee0/documents/71968624-a038-42bd-9596-e8e0f42d307e_d2970b43-73dd-4ff5-9ab6-a45d2f9488bf.html,,,,,, "Phosphoric acid, 2-ethylhexyl ester, ammonium salt",86014-62-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd0f38cb-b591-450d-8e78-2c45fdfb3ee0/documents/71968624-a038-42bd-9596-e8e0f42d307e_d2970b43-73dd-4ff5-9ab6-a45d2f9488bf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "Phosphoric acid, 2-ethylhexyl ester, ammonium salt",86014-62-2,"OECD 423 (2017) - In an acute oral toxicity study (OECD 423), groups of fasted, 8-9 week old, female Crl:WI(Han) rats were given a single oral dose of Reaction mass of Ammonium mono(2-ethylhexyl)phosphate, Ammonium bis(2-ethylhexyl)phosphate and 2-ethylhexyl diphosphate ammonium salts at doses of 2000 and 300 mg/kg bw and observed for 14 days. Oral LD50 (female) = >300 - 2000 mg/kg bw.   OECD 402 (2018) - In an acute dermal toxicity study (OECD 402), groups of 9 - 11 week old, female Crl:WI(Han) rats were given a single semi-occlusive dose of Reaction mass of Ammonium mono(2-ethylhexyl)phosphate, Ammonium bis(2-ethylhexyl)phosphate and 2-ethylhexyl diphosphate ammonium salts in water) at a dose of 2000 mg/kg bw and observed for 14 days. Dermal LD50 (female) = >2000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): A key study is submitted that was conducted in accordance with international guidelines and in accordance with GLP. The presented data are consistent with data requirements for the registrant’s tonnage band Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): A key study is submitted that was conducted in accordance with international guidelines and in accordance with GLP. The presented data are consistent with data requirements for the registrant’s tonnage band ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd0f38cb-b591-450d-8e78-2c45fdfb3ee0/documents/dfbc89c8-0427-4e96-aaed-61b6c3a4a9de_d2970b43-73dd-4ff5-9ab6-a45d2f9488bf.html,,,,,, "Phosphoric acid, 2-ethylhexyl ester, ammonium salt",86014-62-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd0f38cb-b591-450d-8e78-2c45fdfb3ee0/documents/dfbc89c8-0427-4e96-aaed-61b6c3a4a9de_d2970b43-73dd-4ff5-9ab6-a45d2f9488bf.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, "Phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol]",73070-48-1," In accordance with Annex VII of REACH, Column 2, the acute toxicity does not need to be investigated as phosphoric acid, 2-ethylhexyl ester, compd. with 2,2'-iminobis[ethanol] is classified as corrosive to the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4928a06a-ed35-4faf-a2c7-b4e43ca22963/documents/8024cc7d-a072-4ba2-8351-43661050fc12_32fe8b95-0a1b-499c-933e-c31e5c7b0c3f.html,,,,,, "Phosphoric acid, 2-ethylhexyl ester, sodium salt",68186-64-1," Based on the results of an OECD 422  and GLP compliant study with the test item in rat, the following NOAELs were determined: NOAEL systemic = 450 mg/kg bw/d NOAEL local = 200 mg/kg bw/d (i.e. 40 mg/mL) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bed50aec-52ad-4dc4-8442-de5594c7fdb0/documents/f6c95a79-bba3-4db5-a8db-e18a477bbe4b_8531d9c3-5fbb-4217-a75d-15be124f525d.html,,,,,, "Phosphoric acid, 2-ethylhexyl ester, sodium salt",68186-64-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bed50aec-52ad-4dc4-8442-de5594c7fdb0/documents/f6c95a79-bba3-4db5-a8db-e18a477bbe4b_8531d9c3-5fbb-4217-a75d-15be124f525d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat "Phosphoric acid, 2-ethylhexyl ester, sodium salt",68186-64-1," Studies on acute oral, dermal or inhalation toxicity do not need to be conducted according to REACH Annex VII and VIII Section 8.5, Column 2 since the test item is classified as skin corrosive and severely eye damaging cat 1 according to CLP. However, based on available studies on acute oral toxicity with the test item at different compositions, i. e. 40 - 46 % water, the LD50 of the tested substance was > 2000, 5000 or 6700 mg/kg bw in rats. This corresponds to a corrected LD50 of at least greater than 2000 mg/kg bw of the substance registered. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bed50aec-52ad-4dc4-8442-de5594c7fdb0/documents/39a15907-d8bb-47e7-895b-104a3f71ef8e_8531d9c3-5fbb-4217-a75d-15be124f525d.html,,,,,, "Phosphoric acid, 2-ethylhexyl ester, sodium salt",68186-64-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bed50aec-52ad-4dc4-8442-de5594c7fdb0/documents/39a15907-d8bb-47e7-895b-104a3f71ef8e_8531d9c3-5fbb-4217-a75d-15be124f525d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Di-tert-butyl phosphate,33494-81-4,- Acute toxicity by oral route: The acute oral median lethal dose (LD50) of Di-tert-butyl phosphate in rat was calculated to be greater than 2372 mg/kg bw.- Acute toxicity by inhalation route: no data available.- Acute toxicity by dermal route: no data available ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e9dbc5a-4962-4578-b44d-edc01fd20ed2/documents/IUC5-f8455033-bb48-4730-b5b2-052650732a36_fde2f675-f844-4b9a-b17a-39e37de26c4c.html,,,,,, Potassium di-tert-butyl phosphate,33494-80-3," In a GLP compliant acute oral toxicity study, performed according to OECD guideline 423, the test item was administered to two groups of 3 female Wister rats at a single dose level of 2000 mg/kg bw. No mortalities or clinical signs were noted. In conclusion, the LD50 of the test item is determined to be> 2000 mg/kg body weight by oral route in the rat. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/566e8ebc-053f-4e68-a011-25be1c7ed9d2/documents/8dcde26b-22c9-4d9a-a8a3-091d73beaa37_44008da8-92e8-471d-b962-28db7ee5b76a.html,,,,,, Potassium di-tert-butyl phosphate,33494-80-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/566e8ebc-053f-4e68-a011-25be1c7ed9d2/documents/8dcde26b-22c9-4d9a-a8a3-091d73beaa37_44008da8-92e8-471d-b962-28db7ee5b76a.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Phosphoric acid, butyl ester",12788-93-1," The test item Hordaphos MDB was administered daily by oral route to Wistar rats for a period of 90 consecutive days. A recovery period of 28 days without test item treatment was included in this study. Three groups consisting of 10 male and 10 female rats each were treated at dose levels of 50, 200 and 400 mg/kg, respectively. Concurrently, vehicle control, vehicle control recovery and test item high dose recovery groups (400 mg/kg) were used in the present study. All the animals survived up to the scheduled sacrifice. No test item related changes in clinical signs, detailed clinical observation, functional observation battery, ophthalmic examination findings, organ weight and body weight changes were noted. The dullness observed in the in high dose (G4 & G4R) were considered to be without toxicological relevance. Minor changes in hematological, clinical biochemistry, body weight, feed consumption and urine analysis were recorded at the end of treatment and recovery periods, but the variations were considered incidental as there was no dose dependent trend in the observed variations and the respective tissues revealed no abnormalities in macroscopic and histopathological examination. Post-mortem examinations revealed no test item-related macroscopic findings in treated animals. Microscopic examination revealed abnormalities in non glandular stomach attributable to the test item HORDAPHOS MDB at 50, 200 and 400 mg/kg bw in both sexes. The lesion was considered non adverse as complete recovery was observed at the end of 28 day recovery period. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cf705f7-04b7-4c45-b29a-d0235337ef49/documents/efcaf961-7a74-433c-9242-066f011cfb12_79fbb834-9a76-4493-ab73-9e4a19ce4f0f.html,,,,,, "Phosphoric acid, butyl ester",12788-93-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2cf705f7-04b7-4c45-b29a-d0235337ef49/documents/efcaf961-7a74-433c-9242-066f011cfb12_79fbb834-9a76-4493-ab73-9e4a19ce4f0f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat "Phosphoric acid, butyl ester",12788-93-1,"Acute toxicity after single oral application was tested in several tests in which With reference to the most conservative approach for LD50 derivation the study which leads to the lowest limit value is described as follows:female rats received up to 4000 mg/kg bw. Two females out of ten died at 2000 mg/kg bw, 7 at 2500 mg/kg bw, 7 at 3200 mg/kg bw/d and all animals at 4000 mg/kg bw. The LD50 value for acute oral toxicity was calculated to be 2474 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cf705f7-04b7-4c45-b29a-d0235337ef49/documents/IUC5-bcac9bc4-2b12-4f06-968e-cae270d61020_79fbb834-9a76-4493-ab73-9e4a19ce4f0f.html,,,,,, "Phosphoric acid, butyl ester",12788-93-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cf705f7-04b7-4c45-b29a-d0235337ef49/documents/IUC5-bcac9bc4-2b12-4f06-968e-cae270d61020_79fbb834-9a76-4493-ab73-9e4a19ce4f0f.html,,oral,discriminating dose,"2,474 mg/kg bw",adverse effect observed, "Phosphoric acid, butyl ester, sodium salt",53126-67-3, In a combined repeated dose oral gavage toxicity study with the reproduction/developmental toxicity screening with the structural analogue dibutyl phosphate the No-Observed-Adverse-Effect Level (NOAEL) for general toxicity was considered to be 30 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7dfae8b5-5d63-4281-a4d9-8b5890667875/documents/3a78a26d-93f7-4584-af10-f95aeecb2157_99dde68a-71c9-4024-886a-a6838d203be1.html,,,,,, "Phosphoric acid, butyl ester, sodium salt",53126-67-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7dfae8b5-5d63-4281-a4d9-8b5890667875/documents/3a78a26d-93f7-4584-af10-f95aeecb2157_99dde68a-71c9-4024-886a-a6838d203be1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "Phosphoric acid, butyl ester, sodium salt",53126-67-3, oral: The LD50 of the test item is greater than 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7dfae8b5-5d63-4281-a4d9-8b5890667875/documents/9266f65d-47d5-4234-b212-9837cff33b82_99dde68a-71c9-4024-886a-a6838d203be1.html,,,,,, "Phosphoric acid, butyl ester, sodium salt",53126-67-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7dfae8b5-5d63-4281-a4d9-8b5890667875/documents/9266f65d-47d5-4234-b212-9837cff33b82_99dde68a-71c9-4024-886a-a6838d203be1.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Phosphoric acid, C12-18-alkyl esters, potassium salts",90506-43-7,"A NOAEL for systemic toxicity of 1000 mg/kg bw/day was established for Phosphoric acid, C12-18-alkyl esters, potassium salts based on read-across information from an OECD 422 guideline study with Phosphoric acid, dodecyl ester, sodium salt. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f857cf9f-e147-4b35-863b-6a19e9677b24/documents/68fae43a-ec82-49af-82e7-60f939e33b8b_c3b54a4d-2f52-4ce8-8dbe-7442ed897756.html,,,,,, "Phosphoric acid, C12-18-alkyl esters, potassium salts",90506-43-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f857cf9f-e147-4b35-863b-6a19e9677b24/documents/68fae43a-ec82-49af-82e7-60f939e33b8b_c3b54a4d-2f52-4ce8-8dbe-7442ed897756.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Phosphoric acid, C12-18-alkyl esters, potassium salts",90506-43-7,The oral LD50 female was determined to be > 2000 mg/kg bw.   ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f857cf9f-e147-4b35-863b-6a19e9677b24/documents/8f14e84e-179a-4ab8-9056-07481e9f3faa_c3b54a4d-2f52-4ce8-8dbe-7442ed897756.html,,,,,, "Phosphoric acid, C12-18-alkyl esters, potassium salts",90506-43-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f857cf9f-e147-4b35-863b-6a19e9677b24/documents/8f14e84e-179a-4ab8-9056-07481e9f3faa_c3b54a4d-2f52-4ce8-8dbe-7442ed897756.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Phosphoric acid, C14-15 branched and linear alkyl esters, potassium salts",1893414-79-3," The NOAEL (No Observed Adverse Effect Level) of Phosphoric acid, C14-15-branched and linear alkyl esters, potassium salts in this study for general toxicity and reproductive toxicity screening could be established at 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3299980-c812-49bd-b26a-d6ef8cdb3c89/documents/8cb5b3d9-c8b7-4ce4-a427-a034f098efc6_645a3b2c-bef8-4869-a0d6-b074a3d755d9.html,,,,,, "Phosphoric acid, C14-15 branched and linear alkyl esters, potassium salts",1893414-79-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3299980-c812-49bd-b26a-d6ef8cdb3c89/documents/8cb5b3d9-c8b7-4ce4-a427-a034f098efc6_645a3b2c-bef8-4869-a0d6-b074a3d755d9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Phosphoric acid, C14-15 branched and linear alkyl esters, potassium salts",1893414-79-3," The median lethal dose of Phosphoric acid, C14-15-branched and linear alkyl esters, potassium salts after a single oral administration to female rats, observed over a period of 14 days is LD50 cut-off (rat) > 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3299980-c812-49bd-b26a-d6ef8cdb3c89/documents/38656e63-7e59-4090-b89d-3e2c97089156_645a3b2c-bef8-4869-a0d6-b074a3d755d9.html,,,,,, "Phosphoric acid, C14-15 branched and linear alkyl esters, potassium salts",1893414-79-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3299980-c812-49bd-b26a-d6ef8cdb3c89/documents/38656e63-7e59-4090-b89d-3e2c97089156_645a3b2c-bef8-4869-a0d6-b074a3d755d9.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Phosphoric acid, C16-18-alkyl esters, potassium salts",90506-45-9,"Subchronic (90-day) study oral (gavage), rat (Sprague-Dawley) m/f (OECD guideline 408, GLP): BMDL10: 240.30 mg/kg bw/d (corresponding BMD = 374.61 mg/kg bw/d) (both sexes); read-across substance Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts  Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test oral (gavage), rat (Sprague-Dawley) m/f (OECD guideline 422, GLP no data): NOAEL systemic toxicity: 1000 mg/kg bw/day (both sexes); read-across substance Phosphoric acid, dodecyl ester, sodium salt  Subacute (28-day) study oral (dietary), rat (Sprague-Dawley) m/f (OECD guideline 407, GLP): NOAEL (females) 1564 mg/kg bw/day (= NOEL males); read-across substance Mono-myristyl phosphate   Reliable data on repeated dose toxicity of Phosphoric acid esters (PAE) are available from 42-day and 90-day gavage studies as well as from a 28-day feeding study in rats on read-across substances (Phosphoric acid, dodecyl ester, sodium salt; Mono-myristyl phosphate; Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts).  The main effects observed were local irritative effects at the site of application (forestomach gastritis) seen in the gavage studies, focal corticomedullary mineralisation in the kidneys of female rats and hypertrophy of the cortical glomerular zone of the adrenal gland. The findings in the forestomach as well as in the kidneys are either judged as not substance related or as not relevant in view of a potential serious health risk for humans due to significant different anatomic situation and exposure probability in humans. Based on these data, the most critical effects were seen in the adrenal glands showing hypertrophy of the zona glomerulosa in the 90 d study. The BMDL10 is 240.30 mg/kg bw/d (corresponding BMD = 374.61 mg/kg bw/d). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d1a55b90-c011-43dc-af45-0490cad3f356/documents/IUC5-fd6590b4-2e54-4932-aea4-ead2fcfa10be_3ef8d37a-7ecc-4cfb-8301-a8e975c20738.html,,,,,, "Phosphoric acid, C16-18-alkyl esters, potassium salts",90506-45-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d1a55b90-c011-43dc-af45-0490cad3f356/documents/IUC5-fd6590b4-2e54-4932-aea4-ead2fcfa10be_3ef8d37a-7ecc-4cfb-8301-a8e975c20738.html,Sub-chronic toxicity – systemic effects,oral,BMDL10,240.3 mg/kg bw/day,,rat "Phosphoric acid, C16-18-alkyl esters, potassium salts",90506-45-9,Acute oral LD 50 > 2000 mg/kg bwAcute dermal LD 50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1a55b90-c011-43dc-af45-0490cad3f356/documents/IUC5-dc4d635c-3c2d-4bca-936f-63ee99cc68b2_3ef8d37a-7ecc-4cfb-8301-a8e975c20738.html,,,,,, "Phosphoric acid, C16-18-alkyl esters, potassium salts",90506-45-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1a55b90-c011-43dc-af45-0490cad3f356/documents/IUC5-dc4d635c-3c2d-4bca-936f-63ee99cc68b2_3ef8d37a-7ecc-4cfb-8301-a8e975c20738.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Phosphoric acid, C16-18-alkyl esters, potassium salts",90506-45-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1a55b90-c011-43dc-af45-0490cad3f356/documents/IUC5-dc4d635c-3c2d-4bca-936f-63ee99cc68b2_3ef8d37a-7ecc-4cfb-8301-a8e975c20738.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Phosphoric acid, C8-10-alkyl esters",98653-76-0," Oral toxicity: The acute oral median lethal dose (LD50) of an analogue test item in the female Wistar strain rat was found to be > 2000 mg/kg bw (OECD 423, EU Method B.1 Tris and OPPTS 870.1100).   Dermal toxicity: The acute dermal median lethal dose (LD50) of an analogue test item was found to be > 2000 mg/kg bw in male and female Sprague Dawley rats(OECD Guideline 402, EU Method B.3 and OPPTS 870.1200). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f50302ed-efa3-4758-9574-4665a6f4829d/documents/ea4bb0a0-5750-472b-99eb-60ea9afee940_7862105d-2748-45e9-95b7-7895000179c6.html,,,,,, "Phosphoric acid, decyl octyl ester",68186-45-8," Based on the results of the read across study, the NOAEL for systemic toxicity due to the test substance, mono- and di- C8-10 PSE, can be considered to be at 500 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d7c71dc-7a43-41d2-bd20-c5148777300c/documents/7ecd50f9-e91b-4248-9d14-eb9dc0370a06_f2585370-c33a-45b2-a4dd-af6023153440.html,,,,,, "Phosphoric acid, decyl octyl ester",68186-45-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d7c71dc-7a43-41d2-bd20-c5148777300c/documents/7ecd50f9-e91b-4248-9d14-eb9dc0370a06_f2585370-c33a-45b2-a4dd-af6023153440.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Phosphoric acid, isononyl ester",84988-61-4,In an OECD 422 study in rats the NOAEL was 250 mg/kg. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01fcd5ed-2f32-4cfe-a388-246a75df3ec8/documents/IUC5-6de88606-12e9-4259-aee0-1d1346c70137_97c50021-1e1a-46c8-8792-d328a95e80e5.html,,,,,, "Phosphoric acid, isononyl ester",84988-61-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01fcd5ed-2f32-4cfe-a388-246a75df3ec8/documents/IUC5-6de88606-12e9-4259-aee0-1d1346c70137_97c50021-1e1a-46c8-8792-d328a95e80e5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Phosphoric acid, isononyl ester",84988-61-4,The oral LD50 of the substance in the rat was approximately 2500 mg/kg. Acute dermal and acute inhalation studies were not conducted due to the corrisivity of the substance. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01fcd5ed-2f32-4cfe-a388-246a75df3ec8/documents/IUC5-867f2468-a9be-41da-8fe7-d4c981a74174_97c50021-1e1a-46c8-8792-d328a95e80e5.html,,,,,, "Phosphoric acid, isononyl ester",84988-61-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01fcd5ed-2f32-4cfe-a388-246a75df3ec8/documents/IUC5-867f2468-a9be-41da-8fe7-d4c981a74174_97c50021-1e1a-46c8-8792-d328a95e80e5.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "Phosphoric acid, mixed decyl and octyl esters, compds. with diethanolamine",68425-57-0," On the basis of this combined repeated dose oral toxicity and reproduction/developmental toxicity screening test with the test item in male and female Wistar rats with dose levels of 20, 60, and 200 mg/kg body weight day the following conclusions can be made: Based on mortality, a slight effect on body weight development and a slight anemia in male animals, the dose level of 200 mg/kg/d is considered in the toxic range. Therefore, the NOAEL for general toxicity is considered to be 60 mg/kg/d. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/deb88a42-78d1-4732-82c8-4fbe1819069b/documents/4ac15b20-fa4e-4504-ada9-6ca64c19c07c_20d79361-f3fd-4f13-843b-7519673935e7.html,,,,,, "Phosphoric acid, mixed decyl and octyl esters, compds. with diethanolamine",68425-57-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/deb88a42-78d1-4732-82c8-4fbe1819069b/documents/4ac15b20-fa4e-4504-ada9-6ca64c19c07c_20d79361-f3fd-4f13-843b-7519673935e7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat "Phosphoric acid, mixed decyl and octyl esters, compds. with diethanolamine",68425-57-0," The acute oral toxiclty of the test item was investigated in young Wistar rats, breeder Winkelmann, Borchen. The test compound was administered by single gavage in 1 % Carboxymethylcellulose and 0.5 % Cremophor as solvent and an application volume of 10 ml kg-1 body weight to fasted animals. Two rats were used per sex. Under the conditions of the present study, a single oral application of the test item to rats at a dose of 2000 mg/kg body weight was not associated with signs of toxicity or mortality. The LD50 dose of the test item after a single oral administration to male and female rats, observed over a period of 14 days is, according to OECD Guideline 401 is greater than 2000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/deb88a42-78d1-4732-82c8-4fbe1819069b/documents/7b775f4b-7e31-4131-8b1e-b02b16842a73_20d79361-f3fd-4f13-843b-7519673935e7.html,,,,,, "Phosphoric acid, mixed decyl and octyl esters, compds. with diethanolamine",68425-57-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/deb88a42-78d1-4732-82c8-4fbe1819069b/documents/7b775f4b-7e31-4131-8b1e-b02b16842a73_20d79361-f3fd-4f13-843b-7519673935e7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Phosphoric acid, mixed esters with Bu alc. and ethylene glycol",84962-20-9,"Phosphoric acid, mixed esters with butyl alcohol and ethylene glycol was administered daily in graduated doses to 3 groups of test animals for 90 days. Animals of an additional control group were handled identically as the dose groups but received sterile water, the vehicle used in this study. The 4 groups comprised 10 male and 10 female rats.Based on the results of this study, the no-observed-adverse-effect-level (NOAEL) for the test item, Phosphoric acid, mixed esters with butyl alcohol and ethylene glycol, was considered to be 200 mg/kg body weight/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/50ca8152-3b61-4dfa-8c16-ec198618a14c/documents/IUC5-91ac4eb6-847d-492d-860e-bff10a0cc255_b810e80b-5456-4bea-bf7c-8bc68d5763a6.html,,,,,, "Phosphoric acid, mixed esters with Bu alc. and ethylene glycol",84962-20-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/50ca8152-3b61-4dfa-8c16-ec198618a14c/documents/IUC5-91ac4eb6-847d-492d-860e-bff10a0cc255_b810e80b-5456-4bea-bf7c-8bc68d5763a6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Phosphoric acid, mixed esters with Bu alc. and ethylene glycol",84962-20-9,"Acute toxicity after single oral application was tested in female rats, which received up to 5,000 mg/kg bw. Two females out of ten died at 3,200 mg/kg bw, 8 at 4,000 mg/kg bw and all animals at 5,000 mg/kg bw. Observed clinical signs were closed eye lid, abnormal breathing, and crouched posture. The necropsy of the deceased females did only reveal local effects in the stomach. These findings are considered to be attributed to the (mucosa )irritant properties of the test substance and are not considered to be of systemically nature. The LD50 value for acute oral toxicity was calculated to be 3575 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50ca8152-3b61-4dfa-8c16-ec198618a14c/documents/IUC5-8f105241-2913-4fbe-82de-3d824501655a_b810e80b-5456-4bea-bf7c-8bc68d5763a6.html,,,,,, "Phosphoric acid, mixed esters with Bu alc. and ethylene glycol",84962-20-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/50ca8152-3b61-4dfa-8c16-ec198618a14c/documents/IUC5-8f105241-2913-4fbe-82de-3d824501655a_b810e80b-5456-4bea-bf7c-8bc68d5763a6.html,,oral,LD50,"3,575 mg/kg bw",no adverse effect observed, "Phosphoric acid, mono- and di-C11-14 (linear and branched) alkyl esters",154518-38-4,"Subchronic (90-day) study oral (gavage), rat (Sprague-Dawley) m/f (OECD guideline 408, GLP): BMDL10: 240.30 mg/kg bw/d (corresponding BMD = 374.61 mg/kg bw/d) (both sexes); read-across substance Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test oral (gavage), rat (Sprague-Dawley) m/f (OECD guideline 422, GLP no data): NOAEL systemic toxicity: 1000 mg/kg bw/day (both sexes); read-across substance Phosphoric acid, dodecyl ester, sodium salt Subacute (28-day) study oral (dietary), rat (Sprague-Dawley) m/f (OECD guideline 407, GLP): NOAEL (females) 1564 mg/kg bw/day (= NOEL males); read-across substance Mono-myristyl phosphate Reliable data on repeated dose toxicity of Phosphoric acid esters (PAE) are available from 42-day and 90-day gavage studies as well as from a 28-day feeding study in rats on read-across substances (Phosphoric acid, dodecyl ester, sodium salt; Mono-myristyl phosphate; Phosphoric acid, C9-15 branched and linear alkyl esters, potassium salts). The main effects observed were local irritative effects at the site of application (forestomach gastritis) seen in the gavage studies, focal corticomedullary mineralisation in the kidneys of female rats and hypertrophy of the cortical glomerular zone of the adrenal gland. The findings in the forestomach as well as in the kidneys are either judged as not substance related or as not relevant in view of a potential serious health risk for humans due to significant different anatomic situation and exposure probability in humans. Based on these data, the most critical effects were seen in the adrenal glands showing hypertrophy of the zona glomerulosa in the 90 d study. The BMDL10 is 240.30 mg/kg bw/d (corresponding BMD = 374.61 mg/kg bw/d). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20147b90-5d7b-4dcd-a306-389a8de5edc3/documents/IUC5-f9e3a67d-026b-4b66-9982-ffdd1bca1a36_a59cce81-1c98-4b85-b125-0c072a053c63.html,,,,,, "Phosphoric acid, mono- and di-C11-14 (linear and branched) alkyl esters",154518-38-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20147b90-5d7b-4dcd-a306-389a8de5edc3/documents/IUC5-f9e3a67d-026b-4b66-9982-ffdd1bca1a36_a59cce81-1c98-4b85-b125-0c072a053c63.html,Sub-chronic toxicity – systemic effects,oral,BMDL10,240.3 mg/kg bw/day,,rat "Phosphoric acid, mono- and di-C11-14 (linear and branched) alkyl esters",154518-38-4,"Acute oral toxicity: LD50 rat, males and females > 2000 mg/kg bw, OECD Guideline 420, GLP Acute dermal toxicity No acute dermal toxicity studies are available for Phosphoric acid, mono- and di- C11-14 (linear and branched) alkyl esters. Relevant, reliable and adequate data are available for the closely related substances Aluminium dicetyl phosphate (= Aluminium dihexadecyl phosphate) and Dihexadecyl phosphate. Dermal LD50 rat and rabbit, males and females > 2000 mg/kg bw Acute inhalative toxicity According to REACH regulation, Annex VII, 8.5.2, an acute inhalation toxicity study is not required. Inhalation is no relevant route of exposure and testing by inhalation is not appropriate. Exposure of humans via inhalation is unlikely taking into account the possibility of exposure to aerosols, particles or droplets of an inhalable size. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20147b90-5d7b-4dcd-a306-389a8de5edc3/documents/IUC5-46b0026d-45aa-41fd-a3d9-e11abadc4939_a59cce81-1c98-4b85-b125-0c072a053c63.html,,,,,, "Phosphoric acid, mono- and di-C11-14 (linear and branched) alkyl esters",154518-38-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20147b90-5d7b-4dcd-a306-389a8de5edc3/documents/IUC5-46b0026d-45aa-41fd-a3d9-e11abadc4939_a59cce81-1c98-4b85-b125-0c072a053c63.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Phosphoric acid, mono- and di-C11-14 (linear and branched) alkyl esters",154518-38-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20147b90-5d7b-4dcd-a306-389a8de5edc3/documents/IUC5-46b0026d-45aa-41fd-a3d9-e11abadc4939_a59cce81-1c98-4b85-b125-0c072a053c63.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Phosphoric acid, mono- and di-C6-10-alkyl esters",68307-94-8,"The oral administration of the test item to rats by gavage, at dose levels of 50, 160 and 500 mg/kg bw/day, resulted in treatment related effects detected in animals of either sex from all treatment groups. The microscopic changes identified in the liver and thyroid with the associated blood chemical and organ weight changes seen at 500 or 160 mg/kg bw/day were considered to be an adaptive response rather than an adverse effect of treatment.The stomach changes identified together with the associated reductions in body weight and food consumption at 500 mg/kg bw/day may be considered to be an adverse effect of treatment, however they are also considered to be a result of local irritation of the test item rather than a true effect of systemic toxicity. The effects were sufficient to elicit an adaptive response in the adrenal glands.Based on these findings the ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 500 mg/kg bw/day.No treatment related effects were detected in the reproductive parameters examined therefore the ‘No Observed Effect Level’ (NOEL) for reproductive/developmental toxicity was considered to be 500 mg/kg bw/day. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc095926-d682-49d1-9846-77beaba2a33f/documents/IUC5-7d6a455b-f711-4ab0-bb05-05436223dae7_5b42ba02-074f-4b23-b6a7-4801e5f25f8f.html,,,,,, "Phosphoric acid, mono- and di-C6-10-alkyl esters",68307-94-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc095926-d682-49d1-9846-77beaba2a33f/documents/IUC5-7d6a455b-f711-4ab0-bb05-05436223dae7_5b42ba02-074f-4b23-b6a7-4801e5f25f8f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Phosphoric acid, mono- and di-C6-10-alkyl esters",68307-94-8,The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg bodyweight.The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc095926-d682-49d1-9846-77beaba2a33f/documents/IUC5-ce2419ba-2f78-4e64-8391-88cebbff987b_5b42ba02-074f-4b23-b6a7-4801e5f25f8f.html,,,,,, "Phosphoric acid, mono- and di-C6-10-alkyl esters",68307-94-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc095926-d682-49d1-9846-77beaba2a33f/documents/IUC5-ce2419ba-2f78-4e64-8391-88cebbff987b_5b42ba02-074f-4b23-b6a7-4801e5f25f8f.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "Phosphoric acid, mono- and di-C6-10-alkyl esters",68307-94-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc095926-d682-49d1-9846-77beaba2a33f/documents/IUC5-ce2419ba-2f78-4e64-8391-88cebbff987b_5b42ba02-074f-4b23-b6a7-4801e5f25f8f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2.2-(Bis(chloromethyl)trimethylene bis(bis(2-chloro-1-methylethyl)phosphate),1047637-37-5,"Two key studies for the evaluation of repeated dose toxicity of the substance are available. A 28-day oral gavage study in rats according to OECD guidlines 407 and 424 and an oral dietary  2-generation study in rats according to OECD guideline 416. In the latter study histopathology of the target organs of the 28-day study was additionally performed. In the 28-day study groups of 5 male and 5 female Spraque-Dawley rats received daily doses of 0, 15, 150 and 600 mg of the test substance/kg bw  in olive oil by gavage. Treatment related effects in this study were a significantly increased blood cholesterol level in males and females of the high dose group compared to controls, singificantly increased absolute and relative  liver weights in females of the 150 mg/kg bw/day group (35% and 30% respectively), females of the 600 mg/kg bw/day group (78% and 73% respectively) and in males of the high dose group (52% absolute and 68% relative). An increase in absolute and relative thyroid weight was observed in high dose animals. The absolute thyroid weights were increased by 36% and 58% and the relative weights by 48 and 54% in males and females respectively. A slight hepatocellular hypertrophy was observed in 3 of 5 female rats of the 150 mg/kg bw dose group and findings of slight to marked hepatocellular hypertrophy were reported in all males and females of the high dose group. There was no evidence of nuclear or cytoplasmic degenerative or necrotic changes. Thyroid microscopy revealed follicular cell hypertrophy, decreased diameter of follicular lumen and decreased eosinophilic colloidal contents in all animals of the high dose group. These changes are indicative of an increased thyroid activity. This is frequently observed after liver enzyme induction due to increased thyroid hormone turnover in the liver and can thus be secondary to the liver hypertrophy. A NOAEL of 15 mg/kg bw per day was derived from this study based on liver weight changes and liver histopathology ... ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80fbace3-ef70-40be-83e6-75456ffddada/documents/c942c1db-7a98-4b7f-a628-1c4c26389688_2b0fc022-cfe2-405e-b6f9-90a8739652e7.html,,,,,, 2.2-(Bis(chloromethyl)trimethylene bis(bis(2-chloro-1-methylethyl)phosphate),1047637-37-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80fbace3-ef70-40be-83e6-75456ffddada/documents/c942c1db-7a98-4b7f-a628-1c4c26389688_2b0fc022-cfe2-405e-b6f9-90a8739652e7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,, 2.2-(Bis(chloromethyl)trimethylene bis(bis(2-chloro-1-methylethyl)phosphate),1047637-37-5,Oral: LD50 rat > 2000 mg/kg bwInhalation: LC50 rat > 1.65 mg/LDermal: LD50 rat > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80fbace3-ef70-40be-83e6-75456ffddada/documents/dddcfcb0-78a8-4faa-8292-054d3a9ade0f_2b0fc022-cfe2-405e-b6f9-90a8739652e7.html,,,,,, "Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts",84605-29-8,"Repeat dose oral toxicity data is not available for EC 283-392-8, but an OECD 422 study is available for an analogous substance and suitable for read across. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f1c1d2d-ee2b-4991-8a11-ffb59afaa8a7/documents/IUC5-69babe3d-db85-468e-9f2c-34d685d353cc_f439fab9-ac6b-4bee-a762-e7234ad0b88f.html,,,,,, "Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts",84605-29-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f1c1d2d-ee2b-4991-8a11-ffb59afaa8a7/documents/IUC5-69babe3d-db85-468e-9f2c-34d685d353cc_f439fab9-ac6b-4bee-a762-e7234ad0b88f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,160 mg/kg bw/day,,rat "Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts",84605-29-8,The test material is not acute toxic. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f1c1d2d-ee2b-4991-8a11-ffb59afaa8a7/documents/IUC5-a01014c0-72be-4801-b0b0-a2881e32808d_f439fab9-ac6b-4bee-a762-e7234ad0b88f.html,,,,,, "Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts",84605-29-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f1c1d2d-ee2b-4991-8a11-ffb59afaa8a7/documents/IUC5-a01014c0-72be-4801-b0b0-a2881e32808d_f439fab9-ac6b-4bee-a762-e7234ad0b88f.html,,oral,LD50,"3,100 mg/kg bw",, "Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts",84605-29-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f1c1d2d-ee2b-4991-8a11-ffb59afaa8a7/documents/IUC5-a01014c0-72be-4801-b0b0-a2881e32808d_f439fab9-ac6b-4bee-a762-e7234ad0b88f.html,,dermal,LD50,"2,002 mg/kg bw",, "Phosphorodithioic acid, mixed O,O-bis(1,3-dimethylbutyl and iso-Pr) esters, zinc salts",84605-29-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f1c1d2d-ee2b-4991-8a11-ffb59afaa8a7/documents/IUC5-a01014c0-72be-4801-b0b0-a2881e32808d_f439fab9-ac6b-4bee-a762-e7234ad0b88f.html,,inhalation,LC50,"2,300 mg/m3",, "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and iso-Pr) esters, zinc salts",85940-28-9,"28 day study:The oral administration of the test material to rats by gavage, at a maximum dose level of 500 mg/kg/day for 28 days, resulted in adverse, treatment-related changes at 500 and 250 mg/kg/day. There were no treatment-related changes detected in the parameters measured among animals of either sex treated with 125 mg/kg/d. The NOAEL for systemic toxicity was therefore considered to be 125 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd561aab-8c57-437b-a42d-43a5724de8a9/documents/IUC5-c74b5219-260b-4d28-b7fb-92d9a5f70999_f117975d-71e0-4d69-9c7c-5c5e1a6756f8.html,,,,,, "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and iso-Pr) esters, zinc salts",85940-28-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd561aab-8c57-437b-a42d-43a5724de8a9/documents/IUC5-c74b5219-260b-4d28-b7fb-92d9a5f70999_f117975d-71e0-4d69-9c7c-5c5e1a6756f8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and iso-Pr) esters, zinc salts",85940-28-9,The test material is not acutely toxic. Acute toxicity oral: LD50 3000 mg/kg bodyweight (OECD 401)Acute toxicity dermal: LD50 > 20000 mg/kg bodyweight (16CFR1500.3)Acute toxicity inhalation: LC50 > 2000 mg/m3 bodyweight (49CFR173.343 ) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd561aab-8c57-437b-a42d-43a5724de8a9/documents/IUC5-daa4f276-14e1-443a-870d-e7fc05a64a48_f117975d-71e0-4d69-9c7c-5c5e1a6756f8.html,,,,,, "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and iso-Pr) esters, zinc salts",85940-28-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd561aab-8c57-437b-a42d-43a5724de8a9/documents/IUC5-daa4f276-14e1-443a-870d-e7fc05a64a48_f117975d-71e0-4d69-9c7c-5c5e1a6756f8.html,,oral,LD50,"3,080 mg/kg bw",, "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and iso-Pr) esters, zinc salts",85940-28-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd561aab-8c57-437b-a42d-43a5724de8a9/documents/IUC5-daa4f276-14e1-443a-870d-e7fc05a64a48_f117975d-71e0-4d69-9c7c-5c5e1a6756f8.html,,dermal,LD50,"20,000 mg/kg bw",, "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and iso-Pr) esters, zinc salts",85940-28-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd561aab-8c57-437b-a42d-43a5724de8a9/documents/IUC5-daa4f276-14e1-443a-870d-e7fc05a64a48_f117975d-71e0-4d69-9c7c-5c5e1a6756f8.html,,inhalation,LC50,"2,000 mg/m3",, "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and pentyl) esters, zinc salts",68988-45-4,"28 day study:The oral administration of the test material to rats by gavage, at a maximum dose level of 500 mg/kg/day for 28 days, resulted in adverse, treatment-related changes at 500 and 250 mg/kg/day. There were no treatment-related changes detected in the parameters measured among animals of either sex treated with 125 mg/kg/d. The NOAEL for systemic toxicity was therefore considered to be 125 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70e7c8dd-8f7b-4425-b06d-1e33e7222754/documents/IUC5-aa7f6ccd-45ec-4c04-a085-62a670dea96d_8404c296-6ac6-4ded-8028-e9c9cbd130c2.html,,,,,, "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu and pentyl) esters, zinc salts",68988-45-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70e7c8dd-8f7b-4425-b06d-1e33e7222754/documents/IUC5-aa7f6ccd-45ec-4c04-a085-62a670dea96d_8404c296-6ac6-4ded-8028-e9c9cbd130c2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu) esters, zinc salts",68442-22-8,"Repeat dose oral toxicity data is not available for EC 218-679-8-9, but an OECD 422 study is available for an analogous substance EC 270-608-0 and suitable for read across. In this study, the parental NOAEL for systemic toxicity also was determined to be 160 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/960d183b-aedf-4397-ad1f-f11567840b3c/documents/IUC5-8113b56d-9190-4ed4-91c0-e4eec839b76b_47066271-e7e3-462b-a8b6-52f78e64b8cc.html,,,,,, "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu) esters, zinc salts",68442-22-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/960d183b-aedf-4397-ad1f-f11567840b3c/documents/IUC5-8113b56d-9190-4ed4-91c0-e4eec839b76b_47066271-e7e3-462b-a8b6-52f78e64b8cc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,160 mg/kg bw/day,,rat "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu) esters, zinc salts",68442-22-8,The test material is not acutely toxic. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/960d183b-aedf-4397-ad1f-f11567840b3c/documents/IUC5-7d45ec58-88b6-48e2-a6c2-7b327f0369de_47066271-e7e3-462b-a8b6-52f78e64b8cc.html,,,,,, "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu) esters, zinc salts",68442-22-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/960d183b-aedf-4397-ad1f-f11567840b3c/documents/IUC5-7d45ec58-88b6-48e2-a6c2-7b327f0369de_47066271-e7e3-462b-a8b6-52f78e64b8cc.html,,oral,LD50,"2,000 mg/kg bw",, "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Bu) esters, zinc salts",68442-22-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/960d183b-aedf-4397-ad1f-f11567840b3c/documents/IUC5-7d45ec58-88b6-48e2-a6c2-7b327f0369de_47066271-e7e3-462b-a8b6-52f78e64b8cc.html,,dermal,LD50,"2,002 mg/kg bw",, "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Pr) esters, zinc salts",68909-93-3,"Repeat dose oral toxicity data is not available for EC 272-723-1, but an OECD 422 study is available for an analogous substance and suitable for read across. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/921440ca-8412-4c42-a952-adc0e555265d/documents/c5c6cc62-adef-4a1a-b359-b1eea2f6ef6f_967995bd-e25b-485b-959b-50d51544ba7a.html,,,,,, "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Pr) esters, zinc salts",68909-93-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/921440ca-8412-4c42-a952-adc0e555265d/documents/c5c6cc62-adef-4a1a-b359-b1eea2f6ef6f_967995bd-e25b-485b-959b-50d51544ba7a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,160 mg/kg bw/day,,rat "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Pr) esters, zinc salts",68909-93-3,The test material is not acute toxic. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/921440ca-8412-4c42-a952-adc0e555265d/documents/596ad16e-221f-4de4-8d59-2fe087c7d095_967995bd-e25b-485b-959b-50d51544ba7a.html,,,,,, "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Pr) esters, zinc salts",68909-93-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/921440ca-8412-4c42-a952-adc0e555265d/documents/596ad16e-221f-4de4-8d59-2fe087c7d095_967995bd-e25b-485b-959b-50d51544ba7a.html,,oral,LD50,"3,600 mg/kg bw",, "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Pr) esters, zinc salts",68909-93-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/921440ca-8412-4c42-a952-adc0e555265d/documents/596ad16e-221f-4de4-8d59-2fe087c7d095_967995bd-e25b-485b-959b-50d51544ba7a.html,,dermal,LD50,"13,800 mg/kg bw",, "Phosphorodithioic acid, mixed O,O-bis(2-ethylhexyl and iso-Pr) esters, zinc salts",68909-93-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/921440ca-8412-4c42-a952-adc0e555265d/documents/596ad16e-221f-4de4-8d59-2fe087c7d095_967995bd-e25b-485b-959b-50d51544ba7a.html,,inhalation,LC50,"2,000 mg/m3",, "Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts",68457-79-4,The oral repeat dose toxicity of this substance was evaluated with rats at doses as high as 160 mg/kg/day for up to 52 consecutive days in accordance with OECD 422. The NOAEL for systemic toxicity was 160 mg/kg/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/283e6d95-fbae-4290-afab-452b67f89cd2/documents/IUC5-02ab5e11-79a4-4c45-966a-03c0e4b2acf7_ff4d5ac1-d174-4a37-ba39-c3acb28c1d1e.html,,,,,, "Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts",68457-79-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/283e6d95-fbae-4290-afab-452b67f89cd2/documents/IUC5-02ab5e11-79a4-4c45-966a-03c0e4b2acf7_ff4d5ac1-d174-4a37-ba39-c3acb28c1d1e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,160 mg/kg bw/day,,rat "Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts",68457-79-4,The test material is not acute toxic. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/283e6d95-fbae-4290-afab-452b67f89cd2/documents/IUC5-4c913b8a-f58d-40e3-a8bc-df87888b75d3_ff4d5ac1-d174-4a37-ba39-c3acb28c1d1e.html,,,,,, "Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts",68457-79-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/283e6d95-fbae-4290-afab-452b67f89cd2/documents/IUC5-4c913b8a-f58d-40e3-a8bc-df87888b75d3_ff4d5ac1-d174-4a37-ba39-c3acb28c1d1e.html,,oral,LD50,"3,600 mg/kg bw",, "Phosphorodithioic acid, mixed O,O-bis(iso-Bu and pentyl) esters, zinc salts",68457-79-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/283e6d95-fbae-4290-afab-452b67f89cd2/documents/IUC5-4c913b8a-f58d-40e3-a8bc-df87888b75d3_ff4d5ac1-d174-4a37-ba39-c3acb28c1d1e.html,,dermal,LD50,"20,000 mg/kg bw",, "Phosphorodithioic acid, mixed O,O-bis(sec-Bu and 1,3-dimethylbutyl) esters, zinc salts",68784-31-6," 28 day study:The oral administration of the test material to rats by gavage, at a maximum dose level of 500 mg/kg/day for 28 days, resulted in adverse, treatment-related changes at 500 and 250 mg/kg/day. There were no treatment-related changes detected in the parameters measured among animals of either sex treated with 125 mg/kg/d. The NOAEL for systemic toxicity was therefore considered to be 125 mg/kg/day. 90 day study: A test proposal has been submitted for a category of substances of which this substance is a member. Multiple category members will be tested in a comprehensive intelligent testing strategy. Therefore, the read across to this substance will be based on multiple substances. See section 13 for category justification and test proposal. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b4475dc-e6c5-4458-b136-463ce7b6831d/documents/IUC5-5cafd392-946d-4d55-8ddc-78f4b7a46537_e4fe5463-350f-4656-88d3-4d2b61640501.html,,,,,, "Phosphorodithioic acid, mixed O,O-bis(sec-Bu and 1,3-dimethylbutyl) esters, zinc salts",68784-31-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b4475dc-e6c5-4458-b136-463ce7b6831d/documents/IUC5-5cafd392-946d-4d55-8ddc-78f4b7a46537_e4fe5463-350f-4656-88d3-4d2b61640501.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "Phosphorodithioic acid, mixed O,O-bis(sec-Bu and 1,3-dimethylbutyl) esters, zinc salts",68784-31-6,"Oral: This substance does not show evidence of toxicity via the oral route of exposure in animals when tested in accordance with OECD Guideline 401. The oral LD50 is 3400 mg/kg in male rats. At doses of 2900 mg/kg, no toxicity was observed in male or female animals. Therefore, for calculation of the Acute Oral DNEL, the value 2900 mg/kg was selected.Dermal: This substance does not show evidence of toxicity via the dermal route of exposure in animals when tested in accordance with OECD Guideline 402. The dermal LD50 is greater than 2000 mg/kg in male rabbits. Therefore, for calculation of the Acute Dermal DNEL, the value 5000 mg/kg was selected.Inhalation: Substance has a very low volatility (< 0.1 Pa at 20oC) therefore testing is not necessary. Since no Inhalation data are available for this substance, the value used to calculate the Acute Oral DNEL is also used to calculate the Acute Inhalation DNEL. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b4475dc-e6c5-4458-b136-463ce7b6831d/documents/IUC5-5abb4603-0d43-4332-9c0b-c4f35999f390_e4fe5463-350f-4656-88d3-4d2b61640501.html,,,,,, "Phosphorodithioic acid, O,O-di-C1-14-alkyl esters, zinc salts",68649-42-3," Prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound Dialkyl(C1-C14)dithiophosphoric acid, zinc salt. The study assumed the use of male and female Wistar rats in subchronic study of 8 months. No significant alterations were noted at the dose level of 462.0mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for Dialkyl(C1-C14) dithiophosphoric acid, zinc salt is considered to be 462.0mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75e30b14-0fc0-49ce-98e4-8b74940aed19/documents/12b55324-1314-48ef-aae4-6b04bfc362f1_8cc4b623-e215-4f2e-ba20-296dc30cd7ba.html,,,,,, "Phosphorodithioic acid, O,O-di-C1-14-alkyl esters, zinc salts",68649-42-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75e30b14-0fc0-49ce-98e4-8b74940aed19/documents/12b55324-1314-48ef-aae4-6b04bfc362f1_8cc4b623-e215-4f2e-ba20-296dc30cd7ba.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,462 mg/kg bw/day,,rat "Phosphorodithioic acid, O,O-di-C1-14-alkyl esters, zinc salts",68649-42-3," Acute oral toxicity: LD50 was estimated to be 2154 mg/kg bw when female rats were orally exposed with Phosphorodithioic acid, O,O-di-C1-14-alkyl esters, zinc salts.  Acute inhalation toxicity:  LC50 was considered to be > 5,000 mg/m3 when rats were exposed with Phosphorodithioic acid, O,O-di-C1-14-alkyl esters, zinc salts by inhalation. Acute dermal toxicity: LD50 was estimated to be 6965 mg/kg bw when New Zealand White male rabbit were dermally exposed with Phosphorodithioic acid, O,O-di-C1-14-alkyl esters, zinc salts.  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75e30b14-0fc0-49ce-98e4-8b74940aed19/documents/5411ad5f-2381-4d86-9b19-764bb0cd253d_8cc4b623-e215-4f2e-ba20-296dc30cd7ba.html,,,,,, "Phosphorodithioic acid, O,O-di-C1-14-alkyl esters, zinc salts",68649-42-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75e30b14-0fc0-49ce-98e4-8b74940aed19/documents/5411ad5f-2381-4d86-9b19-764bb0cd253d_8cc4b623-e215-4f2e-ba20-296dc30cd7ba.html,,oral,LD50,"2,151 mg/kg bw",no adverse effect observed, "Phosphorodithioic acid, O,O-di-C1-14-alkyl esters, zinc salts",68649-42-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75e30b14-0fc0-49ce-98e4-8b74940aed19/documents/5411ad5f-2381-4d86-9b19-764bb0cd253d_8cc4b623-e215-4f2e-ba20-296dc30cd7ba.html,,dermal,LD50,"6,965 mg/kg bw",no adverse effect observed, "Phosphorodithioic acid, O,O-di-C1-14-alkyl esters, zinc salts",68649-42-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75e30b14-0fc0-49ce-98e4-8b74940aed19/documents/5411ad5f-2381-4d86-9b19-764bb0cd253d_8cc4b623-e215-4f2e-ba20-296dc30cd7ba.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Phosphorodithioic acid, O,O-di-dodecyl-esters, zinc salts, neutral and basic",4563-56-8," NOAEL (oral, rat, 28 days) = 125 mg/kg bw/day RA from CAS 4259-15-8 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56d5d159-5850-4e8b-887a-b56130abc91c/documents/d36177bc-50c5-4c7e-b4af-301961f974a7_b5d3fa6d-c0c9-4218-add7-6f08ca2829b1.html,,,,,, "Phosphorodithioic acid, O,O-di-dodecyl-esters, zinc salts, neutral and basic",4563-56-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56d5d159-5850-4e8b-887a-b56130abc91c/documents/d36177bc-50c5-4c7e-b4af-301961f974a7_b5d3fa6d-c0c9-4218-add7-6f08ca2829b1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "Phosphorodithioic acid, O,O-di-dodecyl-esters, zinc salts, neutral and basic",4563-56-8, Oral LD50 > 2000 mg/kg bw RA from CAS 4259-15-8 Dermal LD50 > 5000 mg/kg bw RA from CAS 4259-15-8 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56d5d159-5850-4e8b-887a-b56130abc91c/documents/4a0a893d-76fc-4a7d-820b-b82fec2341a4_b5d3fa6d-c0c9-4218-add7-6f08ca2829b1.html,,,,,, "Phosphorodithioic acid, O,O-di-dodecyl-esters, zinc salts, neutral and basic",4563-56-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56d5d159-5850-4e8b-887a-b56130abc91c/documents/4a0a893d-76fc-4a7d-820b-b82fec2341a4_b5d3fa6d-c0c9-4218-add7-6f08ca2829b1.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "Phosphorodithioic acid, O,O-di-dodecyl-esters, zinc salts, neutral and basic",4563-56-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56d5d159-5850-4e8b-887a-b56130abc91c/documents/4a0a893d-76fc-4a7d-820b-b82fec2341a4_b5d3fa6d-c0c9-4218-add7-6f08ca2829b1.html,,dermal,LD50,"5,000 mg/kg bw",adverse effect observed, N-propylphosphorothioic triamide,916809-14-8,"28-day oral study (BASF, 2009): NOAEL males: 18.1 mg/kg bw/day; NOAEL females: 19.8 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36a510cd-4a2d-4fc2-91c6-adbb03cc0126/documents/IUC5-74f92a85-1cf6-4911-8013-a8de7b69a4a3_ddf88b7d-404f-455d-9800-e0b8829bb5c5.html,,,,,, N-propylphosphorothioic triamide,916809-14-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36a510cd-4a2d-4fc2-91c6-adbb03cc0126/documents/IUC5-74f92a85-1cf6-4911-8013-a8de7b69a4a3_ddf88b7d-404f-455d-9800-e0b8829bb5c5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,18.1 mg/kg bw/day,,rat N-propylphosphorothioic triamide,916809-14-8,"LD50(oral) > 2000 mg/kg (BASF, 2008)LD50(dermal) > 2000 mg/kg (BASF, 2010) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36a510cd-4a2d-4fc2-91c6-adbb03cc0126/documents/IUC5-47a1069c-162a-4ffa-a37a-4507a3d79dc2_ddf88b7d-404f-455d-9800-e0b8829bb5c5.html,,,,,, N-propylphosphorothioic triamide,916809-14-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36a510cd-4a2d-4fc2-91c6-adbb03cc0126/documents/IUC5-47a1069c-162a-4ffa-a37a-4507a3d79dc2_ddf88b7d-404f-455d-9800-e0b8829bb5c5.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, N-propylphosphorothioic triamide,916809-14-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36a510cd-4a2d-4fc2-91c6-adbb03cc0126/documents/IUC5-47a1069c-162a-4ffa-a37a-4507a3d79dc2_ddf88b7d-404f-455d-9800-e0b8829bb5c5.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Reaction mass of bis[2,4-bis(2-methylbutan-2-yl)phenyl] 4-(2-methylbutan-2-yl)phenyl phosphite and 2,4-bis(2-methylbutan-2-yl)phenyl bis[4-(2-methylbutan-2-yl)phenyl] phosphite and tris[4-(2-methylbutan-2-yl)phenyl] phosphite.",939402-02-5,The substance was found to be non-toxic during a 90 day repeat dose oral exposure study in the rat. A 21 day palatability study was initially conducted to provide information for the selection of dose levels for further repeated dose toxicity studies. Repeat dose studies via the dermal and inhalation routes of exposure were not conducted on the basis of a lack of exposure to the substance. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d27a3e3-57b2-4087-b309-cfb1dd6b8d5c/documents/IUC5-e848cad5-b602-4dfb-b8a7-8f662925d504_98c26012-8716-484b-8257-bcc08209f58a.html,,,,,, "Reaction mass of bis[2,4-bis(2-methylbutan-2-yl)phenyl] 4-(2-methylbutan-2-yl)phenyl phosphite and 2,4-bis(2-methylbutan-2-yl)phenyl bis[4-(2-methylbutan-2-yl)phenyl] phosphite and tris[4-(2-methylbutan-2-yl)phenyl] phosphite.",939402-02-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8d27a3e3-57b2-4087-b309-cfb1dd6b8d5c/documents/IUC5-e848cad5-b602-4dfb-b8a7-8f662925d504_98c26012-8716-484b-8257-bcc08209f58a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,531 mg/kg bw/day",,rat "Reaction mass of bis[2,4-bis(2-methylbutan-2-yl)phenyl] 4-(2-methylbutan-2-yl)phenyl phosphite and 2,4-bis(2-methylbutan-2-yl)phenyl bis[4-(2-methylbutan-2-yl)phenyl] phosphite and tris[4-(2-methylbutan-2-yl)phenyl] phosphite.",939402-02-5,"ORALThe acute oral toxicity of DVS005u was determined to be LD50 > 2000 mg/kg according to a study performed in accordance with GLP and to the standardised guidelines OECD 420 and EU Method B.1.DERMALThe acute dermal toxicity of DVS005u was determined to be LD50 > 2000 mg/kg according to a study performed in accordance with GLP and to the standardised guidelines OECD 402 and EU Method B.3.INHALATIONIn accordance with point 8.5.5, Column 2, adaptation of Annex VII, testing by the inhalation route is deemed inappropriate as exposure to humans via inhalation is unlikely to occur as the substance does not have a high vapour pressure, and will not be used in a manner likely to produce aerosols or droplets of an inhalable size. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d27a3e3-57b2-4087-b309-cfb1dd6b8d5c/documents/IUC5-216404a7-d55a-41aa-b526-e0c822e163e3_98c26012-8716-484b-8257-bcc08209f58a.html,,,,,, "Reaction mass of bis[2,4-bis(2-methylbutan-2-yl)phenyl] 4-(2-methylbutan-2-yl)phenyl phosphite and 2,4-bis(2-methylbutan-2-yl)phenyl bis[4-(2-methylbutan-2-yl)phenyl] phosphite and tris[4-(2-methylbutan-2-yl)phenyl] phosphite.",939402-02-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d27a3e3-57b2-4087-b309-cfb1dd6b8d5c/documents/IUC5-216404a7-d55a-41aa-b526-e0c822e163e3_98c26012-8716-484b-8257-bcc08209f58a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction mass of bis[2,4-bis(2-methylbutan-2-yl)phenyl] 4-(2-methylbutan-2-yl)phenyl phosphite and 2,4-bis(2-methylbutan-2-yl)phenyl bis[4-(2-methylbutan-2-yl)phenyl] phosphite and tris[4-(2-methylbutan-2-yl)phenyl] phosphite.",939402-02-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d27a3e3-57b2-4087-b309-cfb1dd6b8d5c/documents/IUC5-216404a7-d55a-41aa-b526-e0c822e163e3_98c26012-8716-484b-8257-bcc08209f58a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Phosphorous acid, mixed 2,4-bis(1-methyl-1-phenylethyl)phenyl and isodecyl and 2-(1-methyl-1-phenylethyl)phenyl and 4-(1-methyl-1-phenylethyl)phenyl and phenol triesters)",1404220-73-0," There were no signs of acute toxicity via the oral, dermal or inhalation routes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8ecce99-19d5-4407-aab1-63d63df42231/documents/9912faf0-7ef5-4115-9b77-cab694c525e0_a1fea932-ffbb-4110-84e2-f355d288d3c4.html,,,,,, "Phosphorous acid, mixed 2,4-bis(1-methyl-1-phenylethyl)phenyl and isodecyl and 2-(1-methyl-1-phenylethyl)phenyl and 4-(1-methyl-1-phenylethyl)phenyl and phenol triesters)",1404220-73-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8ecce99-19d5-4407-aab1-63d63df42231/documents/9912faf0-7ef5-4115-9b77-cab694c525e0_a1fea932-ffbb-4110-84e2-f355d288d3c4.html,,oral,LD50,"5,000 mg/kg bw",, "Phosphorous acid, mixed 2,4-bis(1-methyl-1-phenylethyl)phenyl and isodecyl and 2-(1-methyl-1-phenylethyl)phenyl and 4-(1-methyl-1-phenylethyl)phenyl and phenol triesters)",1404220-73-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8ecce99-19d5-4407-aab1-63d63df42231/documents/9912faf0-7ef5-4115-9b77-cab694c525e0_a1fea932-ffbb-4110-84e2-f355d288d3c4.html,,dermal,LD50,"5,000 mg/kg bw",, "Phosphorous acid, mixed 2,4-bis(1-methyl-1-phenylethyl)phenyl and isodecyl and 2-(1-methyl-1-phenylethyl)phenyl and 4-(1-methyl-1-phenylethyl)phenyl and phenol triesters)",1404220-73-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8ecce99-19d5-4407-aab1-63d63df42231/documents/9912faf0-7ef5-4115-9b77-cab694c525e0_a1fea932-ffbb-4110-84e2-f355d288d3c4.html,,inhalation,LC50,"11,700 mg/m3",, "Phosphorous acid, tri-C12-14-alkyl esters",93686-48-7," An OECD 422 modified test was carried out with triisodecyl phosphite used for read across. CD rats were administered the test item by ingestion and showed no treatment related toxicity effects up to 1000 mg/kg bw/d. Moreover, no effects were seen is any of the acute studies by any of the routes, even for Phosphorous acid, tri-C12-14-alkyl esters in the acute oral study. Additionnaly no adverse systemics effects were oserved in the OECD 414 up to 1000 mg/kg bw/d. For these reasons, it is considered not relevant to use other animals for testing Phosphorous acid, tri-C12-14-alkyl esters by inhalation or dermal route and also for testing further repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7efe4a12-6064-456e-9070-c4d28c1162b8/documents/30d2d168-b0b2-41e8-8348-be5531ed03fd_27dba7bb-8d8f-4a59-944b-eab02770ab65.html,,,,,, "Phosphorous acid, tri-C12-14-alkyl esters",93686-48-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7efe4a12-6064-456e-9070-c4d28c1162b8/documents/30d2d168-b0b2-41e8-8348-be5531ed03fd_27dba7bb-8d8f-4a59-944b-eab02770ab65.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Phosphorous acid, tri-C12-14-alkyl esters",93686-48-7," A study performed according to OECD 423, tested Phosphorous acid, tri-C12-14-alkyl esters with 6 female SD albino rats. The test item was administered pure by gavage at 2000 mg/kg bw and no mortality was observed, no effects on behaviour and body weights and no effects was seen at macroscopically examinations of necropsy. Phosphorous acid, tri-C12-14-alkyl esters oral LD50 cutt off was > 5000 mg/kg bw This value was supported by the LD 50 determined > 5000 mg/kg bw in a 401 study with the triisodecyl phosphite used for read across. Two other studies were performed with inhalation and dermal routes: - on rats (nose only) with aerosol (mass median diameter calculated to be 0.48 µm) form during 1 hour, LC50 inhalation  > 12600 mg/m3 (maximum dose tested) - a test was performed with rabbits, without vehicle and during 1 hour application. LD50 dermal  > 5000mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7efe4a12-6064-456e-9070-c4d28c1162b8/documents/35878b28-a272-4d0b-87e9-d5b2337ef6c8_27dba7bb-8d8f-4a59-944b-eab02770ab65.html,,,,,, "Polyphosphoric acids, esters with castor oil",68308-61-2,The test item GARDO TP 10451 was investigated for repeated dose toxicity. The no observed effect level (NOEL) for Gardo TP10451 was considered 1000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70e9cff0-0b73-4fba-85d7-8915f9f68072/documents/IUC5-d6bbd6ca-c8f9-4d70-ad84-8adf948d10ad_213dfcb7-1b28-4e52-9108-3552b7362cf7.html,,,,,, "Polyphosphoric acids, esters with castor oil",68308-61-2,The test substance GARDO TP 10451 was examined in an acute oral and dermal toxicity study in rats. Oral LD50 female animals: > 2000 mg/kg bwDermal LD50 male animals: > 2000 mg/kg bwDermal LD50 female animals: >= 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70e9cff0-0b73-4fba-85d7-8915f9f68072/documents/IUC5-366d9e06-195f-4b53-8ba1-d17cc720825d_213dfcb7-1b28-4e52-9108-3552b7362cf7.html,,,,,, Phosphorus trichloride,7719-12-2,"Older proprietary studies of toxicity by the oral, dermal and inhalation routes are available. Supporting published data are also available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94045b9e-d17d-4a77-b8c2-6498055846c0/documents/IUC5-5abc0966-48ea-42e6-91be-80d5db430eb8_7899175d-b0b9-467d-89ec-c9ed56862928.html,,,,,, Phosphorus trichloride,7719-12-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94045b9e-d17d-4a77-b8c2-6498055846c0/documents/IUC5-5abc0966-48ea-42e6-91be-80d5db430eb8_7899175d-b0b9-467d-89ec-c9ed56862928.html,,oral,LD50,18 mg/kg bw,, Phosphorus trichloride,7719-12-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94045b9e-d17d-4a77-b8c2-6498055846c0/documents/IUC5-5abc0966-48ea-42e6-91be-80d5db430eb8_7899175d-b0b9-467d-89ec-c9ed56862928.html,,dermal,LD50,"1,260 mg/kg bw",, Phosphorus trichloride,7719-12-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94045b9e-d17d-4a77-b8c2-6498055846c0/documents/IUC5-5abc0966-48ea-42e6-91be-80d5db430eb8_7899175d-b0b9-467d-89ec-c9ed56862928.html,,inhalation,LC50,592 mg/m3,, Phosphoryl trichloride,10025-87-3," For phosphoryl trichlorid no valid repeated dose studies are reported for the oral, dermal and inhalation route. ""In water, phosphoryl trichloride hydrolyzes to phosphoric acid and hydrochloric acid with t1/2 < 10 seconds (Riess, 2002): POCl3+ 3 H2O→H3PO4+ 3 HCl""(OECD SIDS for phosphoryl trichloride, 2004).  The pH value of phosphoryl trichloride at 25 °C is approximately 1 (at 5 g/L). Further testing is not required and cannot be justified on scientific grounds or for reasons of animal welfare. The available data of the OECD SIDS (HCl) and the MAK commission (H3PO4) are reported. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ae6d388-598a-4a5a-a921-0a64fb4a5b14/documents/IUC5-59b0f92d-c95b-423c-b448-fd938897d749_1950c505-5def-4020-9785-304cb50f2284.html,,,,,, Phosphoryl trichloride,10025-87-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ae6d388-598a-4a5a-a921-0a64fb4a5b14/documents/IUC5-59b0f92d-c95b-423c-b448-fd938897d749_1950c505-5def-4020-9785-304cb50f2284.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,rat Phosphoryl trichloride,10025-87-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ae6d388-598a-4a5a-a921-0a64fb4a5b14/documents/IUC5-59b0f92d-c95b-423c-b448-fd938897d749_1950c505-5def-4020-9785-304cb50f2284.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 mg/m3,adverse effect observed,rat Phosphoryl trichloride,10025-87-3," Older studies with phosphoryl trichloride regarding toxicity by the oral, dermal and inhalation routes are available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae6d388-598a-4a5a-a921-0a64fb4a5b14/documents/IUC5-c58234cb-eb42-4d74-949b-48e6c930fec6_1950c505-5def-4020-9785-304cb50f2284.html,,,,,, Phosphoryl trichloride,10025-87-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae6d388-598a-4a5a-a921-0a64fb4a5b14/documents/IUC5-c58234cb-eb42-4d74-949b-48e6c930fec6_1950c505-5def-4020-9785-304cb50f2284.html,,oral,LD50,380 mg/kg bw,adverse effect observed, Phosphoryl trichloride,10025-87-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae6d388-598a-4a5a-a921-0a64fb4a5b14/documents/IUC5-c58234cb-eb42-4d74-949b-48e6c930fec6_1950c505-5def-4020-9785-304cb50f2284.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, Phosphoryl trichloride,10025-87-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae6d388-598a-4a5a-a921-0a64fb4a5b14/documents/IUC5-c58234cb-eb42-4d74-949b-48e6c930fec6_1950c505-5def-4020-9785-304cb50f2284.html,,inhalation,LC50,303 mg/m3,adverse effect observed, "Tungstate(3-), tetracosa-μ-oxododecaoxo[μ12-[phosphato(3-)-κO:κO:κO:κO':κO':κO':κO'':κO'':κO'':κO''':κO''':κO''']]dodeca-, hydrogen, hydrate (1:3:?)",12501-23-4, The acute oral LD50 in rats was calculated to be > 300 < 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3eaae277-982f-412b-ba05-7a335252f584/documents/3126a4cb-5342-47af-80f0-e3de4bf130fb_38692278-fbb9-4496-87df-89459fdb18db.html,,,,,, Phthalaldehyde,643-79-8," Suitable data is available for ortho-phthalaldehyde (target substance). Repeated dose inhalation toxicity studies (sub-chronic, 14 weeks) in rats and mice were conducted within the US NTP programme for ortho-phthalaldehyde. In these studies, a LOAEC (local) is considered to be 2.4 mg/L based on nasal cavity lesions indicating an irritant effect of ortho-phthalaldehyde in mice and rats. In rats, the LOAEC (systemic) is considered to be 4.8 mg/L based on clinical signs, decreased body weights, hematology findings and decreased organ weights. In the lowest concentration group, no adverse systemic effects were observed and the NOAEC (systemic) can be considered to be 2.4 mg/L. In mice, decreased body weights in males and females were observed still in the lowest concentration group. Thus, no NOAEC could be dertermined and the LOAEC (systemic) is considered to be 2.4 mg/L. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4002121-c905-4e2e-9741-5d957a6e4b72/documents/d9c3c1de-1523-41e8-9e9b-116b1059b3a4_1ac37b6f-8e4b-4281-a114-63d71593bd11.html,,,,,, Phthalaldehyde,643-79-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4002121-c905-4e2e-9741-5d957a6e4b72/documents/d9c3c1de-1523-41e8-9e9b-116b1059b3a4_1ac37b6f-8e4b-4281-a114-63d71593bd11.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,"2,400 mg/m3",,mouse Phthalaldehyde,643-79-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4002121-c905-4e2e-9741-5d957a6e4b72/documents/d9c3c1de-1523-41e8-9e9b-116b1059b3a4_1ac37b6f-8e4b-4281-a114-63d71593bd11.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"2,400 mg/m3",adverse effect observed,rat Phthalaldehyde,643-79-8," For the target substance ortho-phthalaldehyde suitable data is available to assess the acute toxicity for two routes of exposure (oral, dermal). In an acute oral toxicity study conducted according to OECD guideline 401, the acute oral LD50 was determined to be 178.46 mg/kg bw for females, 339.67 mg/kg bw for males and the combined LD 50 was 238.12 mg/kg bw. In an acute dermal toxicity study conducted according to OECD guideline 402, young adult Wistar rats were dermally exposed to ortho-phthalaldehyde in polyethylene glycol at a dose of 2000 mg/kg bw. Due to the absence of mortality, the dermal LD50 in rats is considered to be greater than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4002121-c905-4e2e-9741-5d957a6e4b72/documents/4d0a9a1b-3a4b-49be-9bf0-aca5bccdf077_1ac37b6f-8e4b-4281-a114-63d71593bd11.html,,,,,, Phthalaldehyde,643-79-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4002121-c905-4e2e-9741-5d957a6e4b72/documents/4d0a9a1b-3a4b-49be-9bf0-aca5bccdf077_1ac37b6f-8e4b-4281-a114-63d71593bd11.html,,oral,LD50,178.46 mg/kg bw,adverse effect observed, Phthalic acid,88-99-3," A chronic feeding study with phthalic anhydride at doses of 7.500, or 15.000 ppm (ca. 500, 1000 mg/kg bw/d for 102-106 consecutive weeks, followed by sacrifice, necropsy and histopathological examination of major organs and tissues) was identified as most relevant for the assessment of repeated dose toxicity of phthalic acid. The NOAEL was 500 mg/kg bw/day in this study, based on reduced body-weight gain (<10%). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4637c144-e0f8-4ba3-875a-6d4c87f03674/documents/IUC5-6ec3b98f-d4e3-4580-9e40-1b7943a0f981_9f92fdd9-a4ca-4ef2-a012-eb822fd4df83.html,,,,,, Phthalic acid,88-99-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4637c144-e0f8-4ba3-875a-6d4c87f03674/documents/IUC5-6ec3b98f-d4e3-4580-9e40-1b7943a0f981_9f92fdd9-a4ca-4ef2-a012-eb822fd4df83.html,Chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Phthalic acid,88-99-3," The acute oral toxicity of Phthalic Acid is low. LD50 values >2000 mg/kg were reported in mice and rats. In an acute inhalation study in rats, the aerolized test substance proved to have essentially no acute inhalation toxicity. The LC50 was >5058 mg/m³ in male and female rats. There are no data on acute dermal toxicity available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4637c144-e0f8-4ba3-875a-6d4c87f03674/documents/IUC5-ae08a107-d2ae-4578-b9e8-723b76bb9728_9f92fdd9-a4ca-4ef2-a012-eb822fd4df83.html,,,,,, Phthalic acid,88-99-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4637c144-e0f8-4ba3-875a-6d4c87f03674/documents/IUC5-ae08a107-d2ae-4578-b9e8-723b76bb9728_9f92fdd9-a4ca-4ef2-a012-eb822fd4df83.html,,inhalation,LC50,"5,058 mg/m3",no adverse effect observed, Phthalimide,85-41-6,No adverse effects of the substance were observed fror the tested doses.  ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f981b83-3f45-4fc3-b3bf-1008ef1aba9c/documents/857ca4f7-e194-4f68-8437-c3a3836b7661_6e50fd33-ba79-429f-bc74-1ac2323a22c2.html,,,,,, Phthalimide,85-41-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f981b83-3f45-4fc3-b3bf-1008ef1aba9c/documents/857ca4f7-e194-4f68-8437-c3a3836b7661_6e50fd33-ba79-429f-bc74-1ac2323a22c2.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Phthalimidoacetic acid,4702-13-0, Acute oral toxicity - Supplier data LD50 (rat) = 1800 mg/kg LD50 (mouse) = 1525 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ed50aea-3709-4b7e-950b-a92c53dd959f/documents/419641c2-576e-4d63-85d0-530ac9d031b0_39dd68b2-875b-4015-acdd-cd57ea28e4d9.html,,,,,, Phthalonitrile,91-15-6,"O-phthalonitrile is toxic after acute oral application. Since ortho-phthalonitril is supposed to be toxic via all routes of exposure, classification for acute inhalation and dermal toxicity was adopted for precautionary reasons. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78338dc3-0b12-441d-80a0-f694544d8b6c/documents/IUC5-94c604d3-fd41-4908-b9f3-182196f70e90_560bc4ce-0b3d-40c7-aaf5-5ed00f2db144.html,,,,,, Phthalonitrile,91-15-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78338dc3-0b12-441d-80a0-f694544d8b6c/documents/IUC5-94c604d3-fd41-4908-b9f3-182196f70e90_560bc4ce-0b3d-40c7-aaf5-5ed00f2db144.html,,oral,LD50,125 mg/kg bw,adverse effect observed, picoxystrobin (ISO); methyl (2E)-3-methoxy-2-[2-({[6-(trifluoromethyl)pyridin-2-yl]oxy}methyl)phenyl]acrylate,117428-22-5," 90-Day rat feeding study LOAEL: 1250 ppm (equivalent to 104.9 and 120.1 mg/kg bw/day for males and females, respectively); OECD 408; Reliability = 1 90-Day mouse feeding study LOAEL: 800 ppm (equivalent to 137.3 and 176.1 mg/kg bw/day for males and females, respectively); OECD 408; Reliability = 1 90-Day dog feeding study LOAEL: 500 ppm males (equivalent to 8.9 and 16.9 mg/kg/day for males and females, respectively); OECD 409; Reliability = 1 1-Year dog feeding study LOAEL: 500 ppm (equivalent to 16.1 and 15.7 mg/kg bw/day for males and females, respectively); OECD 452; Reliability = 1 105-Week rat feeding study LOAEL: 3500 ppm (equivalent to 162.1 and 203.3 mg/kg bw/day for males and females, respectively); OECD 453; Reliability = 1 18-Month mouse feeding study LOAEL: 2400 ppm for males (equivalent to 293 mg/kg/day) and >4800 ppm for females (highest dose tested; equivalent to 799 mg/kg bw/day); OECD 451; Reliability = 1 28-Day rat inhalation study LOAEL: >0.025 mg/L (highest concentration tested); OECD 412; Reliability = 1 28-Day rat dermal study LOAEL: >1000 mg/kg/day (highest dose tested); OECD 410; Reliability = 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6583b1a-920a-4d2f-b80b-0609f7a3d29f/documents/19e0b773-2208-4f02-9146-ab1a2246dd82_acdc87b6-684a-45db-a899-aab6ea8412cb.html,,,,,, picoxystrobin (ISO); methyl (2E)-3-methoxy-2-[2-({[6-(trifluoromethyl)pyridin-2-yl]oxy}methyl)phenyl]acrylate,117428-22-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6583b1a-920a-4d2f-b80b-0609f7a3d29f/documents/19e0b773-2208-4f02-9146-ab1a2246dd82_acdc87b6-684a-45db-a899-aab6ea8412cb.html,Chronic toxicity – systemic effects,oral,NOAEL,4.6 mg/kg bw/day,,dog picoxystrobin (ISO); methyl (2E)-3-methoxy-2-[2-({[6-(trifluoromethyl)pyridin-2-yl]oxy}methyl)phenyl]acrylate,117428-22-5, Oral: rat LD50: >5000 mg/kg. OECD 425; Reliability = 1 Oral: mouse LD50: >5000 mg/kg.OECD 425; Reliability = 1 Dermal: rat LD50: >5000 mg/kg. OECD 402; Reliability = 1 Inhalation: rat 4-hour LC50: 3.19 mg/L (3190 mg/m3; females - most sensitive sex); OECD 403; Reliability = 1 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6583b1a-920a-4d2f-b80b-0609f7a3d29f/documents/47f8cbdd-6662-4859-8667-af1931eb5b68_acdc87b6-684a-45db-a899-aab6ea8412cb.html,,,,,, picoxystrobin (ISO); methyl (2E)-3-methoxy-2-[2-({[6-(trifluoromethyl)pyridin-2-yl]oxy}methyl)phenyl]acrylate,117428-22-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6583b1a-920a-4d2f-b80b-0609f7a3d29f/documents/47f8cbdd-6662-4859-8667-af1931eb5b68_acdc87b6-684a-45db-a899-aab6ea8412cb.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, picoxystrobin (ISO); methyl (2E)-3-methoxy-2-[2-({[6-(trifluoromethyl)pyridin-2-yl]oxy}methyl)phenyl]acrylate,117428-22-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6583b1a-920a-4d2f-b80b-0609f7a3d29f/documents/47f8cbdd-6662-4859-8667-af1931eb5b68_acdc87b6-684a-45db-a899-aab6ea8412cb.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, picoxystrobin (ISO); methyl (2E)-3-methoxy-2-[2-({[6-(trifluoromethyl)pyridin-2-yl]oxy}methyl)phenyl]acrylate,117428-22-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6583b1a-920a-4d2f-b80b-0609f7a3d29f/documents/47f8cbdd-6662-4859-8667-af1931eb5b68_acdc87b6-684a-45db-a899-aab6ea8412cb.html,,inhalation,LC50,"3,190 mg/m3",adverse effect observed, Piperazine adipate,142-88-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): K2 data is predicted using the OECD QSAR toolbox version 3.0 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): K2 data is predicted using the OECD QSAR toolbox version 3.0 ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cdea95d6-b41b-46b0-b03d-f7a627588643/documents/IUC5-1a4c7120-aa1d-447c-9e08-a60d09a092db_5465b356-9302-4dc1-8cca-2d8edc73aff8.html,,,,,, Piperazine adipate,142-88-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): K2 data predicted from QSAR toolbox version 3.0 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): K2 data predicted from QSAR toolbox version 3.0 ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cdea95d6-b41b-46b0-b03d-f7a627588643/documents/IUC5-8ae54ff4-e45a-43f5-b63c-2f0eff5e1f60_5465b356-9302-4dc1-8cca-2d8edc73aff8.html,,,,,, Piperazine adipate,142-88-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cdea95d6-b41b-46b0-b03d-f7a627588643/documents/IUC5-8ae54ff4-e45a-43f5-b63c-2f0eff5e1f60_5465b356-9302-4dc1-8cca-2d8edc73aff8.html,,oral,LD50,"3,782 mg/kg bw",no adverse effect observed, "Piperazine, compound with phosphoric acid",1951-97-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Repeated dose toxicity NOAEL (No observed adverse effect level) of piperazine, compound with phosphoric acid to rabbit by the dermal route was estimated at a dose concentration of 551.5 mg/kg bw/day. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): In the estimated study lowest observed effect level (LOEL) value of piperazine, compound with phosphoric acid for repeated dose via inhalation route of exposure on rat is 1357.718 mg/kg/day. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The low observed effect level (LOEL) in rat in a 30 day study was found to be 66 mg/kg bw/day (nominal). ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/24de0bc7-a1eb-4b99-959f-94cd857a9f46/documents/IUC5-9a2c61be-e08d-4284-b7f9-4d1bc32dc139_25b5f520-3381-46bb-933b-938fbfb39dad.html,,,,,, "Piperazine, compound with phosphoric acid",1951-97-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/24de0bc7-a1eb-4b99-959f-94cd857a9f46/documents/IUC5-9a2c61be-e08d-4284-b7f9-4d1bc32dc139_25b5f520-3381-46bb-933b-938fbfb39dad.html,Chronic toxicity – systemic effects,dermal,NOAEL,551.5 mg/kg bw/day,,rabbit "Piperazine, compound with phosphoric acid",1951-97-9,"From the various data available, it has been concluded that the chemical piperazine phosphate is unlikely to exhibit actute toxicity by the oral, inhalation and the dermal route within the dose levels mentioned in the respective end points. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24de0bc7-a1eb-4b99-959f-94cd857a9f46/documents/IUC5-7a63e9b1-a0c8-406c-8fea-14e71dc22422_25b5f520-3381-46bb-933b-938fbfb39dad.html,,,,,, "Piperazine, compound with phosphoric acid",1951-97-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24de0bc7-a1eb-4b99-959f-94cd857a9f46/documents/IUC5-7a63e9b1-a0c8-406c-8fea-14e71dc22422_25b5f520-3381-46bb-933b-938fbfb39dad.html,,oral,LD50,"20,000 mg/kg bw",no adverse effect observed, "Piperazine, compound with phosphoric acid",1951-97-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24de0bc7-a1eb-4b99-959f-94cd857a9f46/documents/IUC5-7a63e9b1-a0c8-406c-8fea-14e71dc22422_25b5f520-3381-46bb-933b-938fbfb39dad.html,,dermal,LD50,"4,000 mg/kg bw",no adverse effect observed, "Piperazine-1,4-diethanol",122-96-3," The LD50 by oral route was 20,093 and 18,738 mg/kg for males and females respectively. LD50 by dermal route was > 10 ml/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb3f9837-a88c-40f2-9e5b-6ff07eaf0db0/documents/fc2b1d3a-b482-4ed4-8472-367afb4f37f7_c2f4c5dd-68a7-4640-b801-0859e21adc38.html,,,,,, Piperidine,110-89-4,"oral read-across piperidine hydrochloride (CAS No. 6091-44-7), non-guideline, no GLP, K2, rat: NOAEL (systemic toxicity) = 80 mg/kg bw, based on the reduced body weight gain; worst case assumption due to a lack of information on study results inhalation:  OECD 412, GLP, K1; rat: NOAEC (systemic) >= 350 mg/m3; NOAEC (local) = 70 mg/m3 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a185aa9b-c59a-4129-80c4-ba8df9fed084/documents/IUC5-bc712fe9-8fbc-4a4c-be4d-4b2b291dc1aa_964b2157-9c36-450b-92aa-e0d858f46b52.html,,,,,, Piperidine,110-89-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a185aa9b-c59a-4129-80c4-ba8df9fed084/documents/IUC5-bc712fe9-8fbc-4a4c-be4d-4b2b291dc1aa_964b2157-9c36-450b-92aa-e0d858f46b52.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,350 mg/m3,,rat Piperidine,110-89-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a185aa9b-c59a-4129-80c4-ba8df9fed084/documents/IUC5-bc712fe9-8fbc-4a4c-be4d-4b2b291dc1aa_964b2157-9c36-450b-92aa-e0d858f46b52.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat Piperidine,110-89-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a185aa9b-c59a-4129-80c4-ba8df9fed084/documents/IUC5-bc712fe9-8fbc-4a4c-be4d-4b2b291dc1aa_964b2157-9c36-450b-92aa-e0d858f46b52.html,Repeated dose toxicity – local effects,inhalation,NOAEC,70 mg/m3,no adverse effect observed,rat Piperidine,110-89-4,"oral: comparable to OECD Guideline 401 (Acute Oral Toxicity), GLP compliant, Klimsch score 2: LD50 = 740 mg/kg bw (rat) inhalation:  comparable to OECD Guideline 403 (Acute Inhalative Toxicity), not GLP compliant, Klimsch score 2: LC50 = 4.8 mg/L (rat) dermal: acceptable non-Guideline Study, not GLP compliant, Klimsch score 2: LD50 = 276 mg/kg bw (rabbit) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a185aa9b-c59a-4129-80c4-ba8df9fed084/documents/IUC5-af0628d8-f741-4652-a3e8-391d93fd9ba4_964b2157-9c36-450b-92aa-e0d858f46b52.html,,,,,, Piperidine,110-89-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a185aa9b-c59a-4129-80c4-ba8df9fed084/documents/IUC5-af0628d8-f741-4652-a3e8-391d93fd9ba4_964b2157-9c36-450b-92aa-e0d858f46b52.html,,oral,LD50,750 mg/kg bw,adverse effect observed, Piperidine,110-89-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a185aa9b-c59a-4129-80c4-ba8df9fed084/documents/IUC5-af0628d8-f741-4652-a3e8-391d93fd9ba4_964b2157-9c36-450b-92aa-e0d858f46b52.html,,dermal,LD50,276 mg/kg bw,adverse effect observed, Piperidine,110-89-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a185aa9b-c59a-4129-80c4-ba8df9fed084/documents/IUC5-af0628d8-f741-4652-a3e8-391d93fd9ba4_964b2157-9c36-450b-92aa-e0d858f46b52.html,,inhalation,LC50,"4,800 mg/m3",adverse effect observed, 4-(4-iodo-1H-pyrazol-1-yl)piperidine,1229457-94-6,"Two studies are available:1) A repeated dose 28-day oral toxicity study by daily gavage in rat (Beerens-Heijnen, 2011) is available which is key study. This study showed that No Observed Adverse Effect Level (NOAEL) for the test substance is 75 mg/kg. 2) A dose range finding study (Beerens-Heijnen, 2011) is available which is supporting study. This study showed that dose levels suggested for the main study are 10, 25 and 75 mg/kg body weight. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01c04843-4bff-4b74-a8fd-566dc2557f6a/documents/IUC5-d80a9f77-3b5a-415e-bb79-c0271eb782cf_250022b2-15ed-4961-8ca2-69ddba64d9cb.html,,,,,, 4-(4-iodo-1H-pyrazol-1-yl)piperidine,1229457-94-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01c04843-4bff-4b74-a8fd-566dc2557f6a/documents/IUC5-d80a9f77-3b5a-415e-bb79-c0271eb782cf_250022b2-15ed-4961-8ca2-69ddba64d9cb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat 4-(4-iodo-1H-pyrazol-1-yl)piperidine,1229457-94-6,"A acute oral study with Wistar rats (Beerens- Heijnen., 2010) is available which is key study. The oral LD50 value of the test substance was established to be within the range of 50-300 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to be 200 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01c04843-4bff-4b74-a8fd-566dc2557f6a/documents/IUC5-f79220d3-2efb-4014-9766-c131c4ef9bab_250022b2-15ed-4961-8ca2-69ddba64d9cb.html,,,,,, 4-(4-iodo-1H-pyrazol-1-yl)piperidine,1229457-94-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01c04843-4bff-4b74-a8fd-566dc2557f6a/documents/IUC5-f79220d3-2efb-4014-9766-c131c4ef9bab_250022b2-15ed-4961-8ca2-69ddba64d9cb.html,,oral,LD50,200 mg/kg bw,adverse effect observed, piperidine-4-carbothioamide,112401-09-9,"In silico prediction for acute oral toxicity based on T.E.S.T., version 4.2.1 (Schlecker, March 2021): Predicted Oral rat LD50 = 118.5 mg/kg BW ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d1904b9-48a0-4c34-8dfd-25a4d7d063a3/documents/c2dc3d1f-32f2-4ffe-b6d8-fc7888432572_1a18093e-98ad-4f50-8f47-3ce957022370.html,,,,,, Pirimiphos-methyl,29232-93-7," - Oral: NOAEL = 0.4 mg/kg bw/day, male/female, rat, 90-day, equivalent to OECD 408, Clapp 1970 - Oral: NOAEL = 0.5 mg/kg bw/day, male/female, dogs, 2-year, equivalent to OECD 409, Rivett 1973 - Oral: NOAEL = 1 mg/kg bw/day, male/female, rat, 28-day, equivalent to OECD 407, Berry 1975 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82ab0489-5aff-4a99-a5d1-4e6abf2cc5f6/documents/d8eef920-8822-4d0d-90d3-005e90a50c2e_c1735154-dd02-4ef2-9d98-cee8cb99c38e.html,,,,,, Pirimiphos-methyl,29232-93-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82ab0489-5aff-4a99-a5d1-4e6abf2cc5f6/documents/d8eef920-8822-4d0d-90d3-005e90a50c2e_c1735154-dd02-4ef2-9d98-cee8cb99c38e.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,40 mg/kg bw/day,,rabbit Pirimiphos-methyl,29232-93-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82ab0489-5aff-4a99-a5d1-4e6abf2cc5f6/documents/d8eef920-8822-4d0d-90d3-005e90a50c2e_c1735154-dd02-4ef2-9d98-cee8cb99c38e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.4 mg/kg bw/day,,rat Pirimiphos-methyl,29232-93-7," - Oral: LD50 = 1414 mg/kg bw, male/female, rat, according to OECD TG 401, Johnson 1999 - Inhalation: Discriminating conc. >5.04 mg/L male/female, rat, similar to OECD TG 403 Lewis 1989 - Dermal: Discriminating conc. >2000 mg/kg bw, male/female, rat, according to OECD TG 402, Johnson 1999 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82ab0489-5aff-4a99-a5d1-4e6abf2cc5f6/documents/1d8fb990-a147-4de0-8d41-724cf0eca27a_c1735154-dd02-4ef2-9d98-cee8cb99c38e.html,,,,,, Pirimiphos-methyl,29232-93-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82ab0489-5aff-4a99-a5d1-4e6abf2cc5f6/documents/1d8fb990-a147-4de0-8d41-724cf0eca27a_c1735154-dd02-4ef2-9d98-cee8cb99c38e.html,,oral,LD50,"1,414 mg/kg bw",adverse effect observed, Pirimiphos-methyl,29232-93-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82ab0489-5aff-4a99-a5d1-4e6abf2cc5f6/documents/1d8fb990-a147-4de0-8d41-724cf0eca27a_c1735154-dd02-4ef2-9d98-cee8cb99c38e.html,,dermal,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, Pirimiphos-methyl,29232-93-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82ab0489-5aff-4a99-a5d1-4e6abf2cc5f6/documents/1d8fb990-a147-4de0-8d41-724cf0eca27a_c1735154-dd02-4ef2-9d98-cee8cb99c38e.html,,inhalation,discriminating conc.,> 5.04 mg/L,no adverse effect observed, p-isopropylphenyl isocyanate,31027-31-3,Acute oral toxicity: LD50 = 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56b6166b-2bdd-4be3-9321-29299bf9f2b8/documents/IUC5-bc3d3933-34ac-4591-97f4-35a62faa5f4b_71597df2-a1de-4a1b-a5a6-47efe929f880.html,,,,,, p-isopropylphenyl isocyanate,31027-31-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56b6166b-2bdd-4be3-9321-29299bf9f2b8/documents/IUC5-bc3d3933-34ac-4591-97f4-35a62faa5f4b_71597df2-a1de-4a1b-a5a6-47efe929f880.html,,oral,LD50,"5,000 mg/kg bw",adverse effect observed, p-isopropylphenyl isocyanate,31027-31-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56b6166b-2bdd-4be3-9321-29299bf9f2b8/documents/IUC5-bc3d3933-34ac-4591-97f4-35a62faa5f4b_71597df2-a1de-4a1b-a5a6-47efe929f880.html,,inhalation,LC50,0.022 mg/L,adverse effect observed, Pivalic acid,75-98-9,The oral gavage O.E.C.D. 407 Testing Guideline 28-day oral repeat dose conducted according to the GLP regulations is the most approriate repeated-dose study for the establishment of DNEL values. The NOAEL from this study for systemic effects was 30 mg/kg/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1831972-05cc-452d-9753-3eb26da5d3f0/documents/IUC5-2f9fc909-a570-4549-bb71-b7038e2888b6_b2466dd0-60e5-40ac-b676-75273b05dff2.html,,,,,, Pivalic acid,75-98-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1831972-05cc-452d-9753-3eb26da5d3f0/documents/IUC5-2f9fc909-a570-4549-bb71-b7038e2888b6_b2466dd0-60e5-40ac-b676-75273b05dff2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,, Pivalic acid,75-98-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f1831972-05cc-452d-9753-3eb26da5d3f0/documents/IUC5-2f9fc909-a570-4549-bb71-b7038e2888b6_b2466dd0-60e5-40ac-b676-75273b05dff2.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,30 mg/kg bw/day,, Pivalic acid,75-98-9,"Pivalic acid is practically not toxic by the oral, dermal and inhalation routes of exposure in laboratory animals. The acute rat oral LD50 was 2000 mg/kg of body weight. The acute rat and guinea pig 4 hr inhalation LC50 was > 4 mg/L and mouse 4 hr inhalation LC100 was <= 4 mg/L . The acute dermal LD50 was 3160 mg/kg of body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1831972-05cc-452d-9753-3eb26da5d3f0/documents/IUC5-d70cd9dd-cd31-4310-b2de-f82eb101b716_b2466dd0-60e5-40ac-b676-75273b05dff2.html,,,,,, Pivalic acid,75-98-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1831972-05cc-452d-9753-3eb26da5d3f0/documents/IUC5-d70cd9dd-cd31-4310-b2de-f82eb101b716_b2466dd0-60e5-40ac-b676-75273b05dff2.html,,oral,LD50,"2,000 mg/kg bw",, Pivalic acid,75-98-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f1831972-05cc-452d-9753-3eb26da5d3f0/documents/IUC5-d70cd9dd-cd31-4310-b2de-f82eb101b716_b2466dd0-60e5-40ac-b676-75273b05dff2.html,,dermal,LD50,"3,160 mg/kg bw",, Pivaloyl chloride,3282-30-2, Pivanoyl chloride is of low systemic toxicity after dermal contact. Due to its causic properties the substance is of moderate toxicity after ingestion. Pivanoyl chloride is toxic via inhalation. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f703b7ba-ffc7-494f-9b60-1036c8e6a586/documents/IUC5-c1e5a58f-ac9b-45c1-83bf-711b04181058_0e08f1c7-592b-45ad-84f0-d6c27a163738.html,,,,,, Platinum dioxide,1314-15-4,"According to a brief summary in an Expert Group report (DECOS, 2008) of a 40-year-old study, male Sprague-Dawley rats received platinum(IV) oxide in the diet at a level corresponding to a dose of about 815 mg/kg bw/day for 4 weeks. No effect on growth was apparent (Holbrook, 1976; Holbrook et al., 1976). Marginal effects on a small number of clinical chemistry parameters [likely including aniline hydroxylase and cytochrome b5 activity] were noted following such treatment (Holbrook et al., 1976). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22140246-5ed5-4ec6-8a4a-079401ef971c/documents/a898d9d7-a2fc-4ec7-b836-ce54e7d36e57_d3606ad0-098e-446c-af3e-7c76e45e8b7b.html,,,,,, Platinum dioxide,1314-15-4,"In an acute oral toxicity study, an LD50 of greater than 3.4 g/kg bw was reported in male rats gavaged with platinum dioxide, and observed for up to 14 days (Holbrook et al., 1975). No relevant acute dermal or inhalation toxicity data were identified, or are required at this tonnage. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22140246-5ed5-4ec6-8a4a-079401ef971c/documents/377ffe54-3e3a-4d65-b3a2-8c144fc3ccf6_d3606ad0-098e-446c-af3e-7c76e45e8b7b.html,,,,,, Platinum dioxide,1314-15-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22140246-5ed5-4ec6-8a4a-079401ef971c/documents/377ffe54-3e3a-4d65-b3a2-8c144fc3ccf6_d3606ad0-098e-446c-af3e-7c76e45e8b7b.html,,oral,LD50,"3,400 mg/kg bw",no adverse effect observed, platinum(IV) nitrate/nitric acid solution,10102-09-7," No relevant repeated dose toxicity data were identified for platinum dinitrate. However, good support for the conclusion that a repeated dose toxicity study can be waived comes from two sources. Firstly, a consideration of the known toxicity and physico-chemical properties of this compound. Platinum dinitrate is a strong acid (pH<2.0) and exhibits skin corrosivity in vitro. Secondly, there are good-quality endpoint-specific data on another platinum (IV) species. In a combined repeated-dose and reproductive/developmental toxicity screening test, no adverse effects were observed at daily doses of hexahydroxyplatinic acid up to 1000 mg/kg bw/day. This supports the hypothesis that, even if testing were possible, platinum dinitrate would not be expected to cause any significant systemic toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/424aa173-d8af-424c-b7b7-b6bc2a384177/documents/60ed21b8-c7fd-46b4-b2f5-60b5dabdc920_597277b7-fe9a-45c7-8510-5ed13ae33cc8.html,,,,,, platinum(IV) nitrate/nitric acid solution,10102-09-7," No relevant acute oral, dermal or inhalation toxicity data were identified. However, acute toxicity testing is not considered appropriate as platinum IV Nitrate solution is considered corrosive. Read-across data for Nitric Acid is included in support of inhalation toxicity end points. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/424aa173-d8af-424c-b7b7-b6bc2a384177/documents/4e62c249-ee1c-41e6-b7eb-835614190fa4_597277b7-fe9a-45c7-8510-5ed13ae33cc8.html,,,,,, 2-[(1S)-4-methylcyclohex-3-en-1-yl]propan-2-ol,10482-56-1," Repeated dose toxicity (oral). Key study. Read-across approach. Test method according to OECD Guideline 422 with GLP. Based on the read-across approach from the analogue terpineol, the NOEL of laevo alpha terpineol after an oral exposure of 44 days was determined to be 100 mg/kg bw/day in male and female rats. Repeated dose toxicity (oral). Supporting study. Read-across approach. Method similar to OECD guideline 408. Based on the read-across approach from the analogue alpha terpinyl acetate after an oral exposure of 20 weeks in rats, the NOAEL of L-alpha terpineol  was determined to be higher than 314 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19e20c9a-70c4-4538-8fc0-8443fc00f58d/documents/a6e9504f-10f6-4be8-bdde-9c8c58c5370e_59e2142e-eeab-4c0f-aba5-12464ae63242.html,,,,,, 2-[(1S)-4-methylcyclohex-3-en-1-yl]propan-2-ol,10482-56-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/19e20c9a-70c4-4538-8fc0-8443fc00f58d/documents/a6e9504f-10f6-4be8-bdde-9c8c58c5370e_59e2142e-eeab-4c0f-aba5-12464ae63242.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat 2-[(1S)-4-methylcyclohex-3-en-1-yl]propan-2-ol,10482-56-1," Acute oral toxicity: Weight of evidence. Read across approach: Based on the read-across approach from the analogue alpha terpineol, the acute oral LD50 value of laevo alpha terpineol in mice is determined to be 2830 mg/kg bw. Acute oral toxicity: Weight of evidence. Read across approach: Based on the read-across approach from the analogue alpha terpinyl acetate, the LD50 of laevo alpha terpineol is calculated to be 3988 mg/kg body weight by oral route in the rat. Acute inhalation toxicity: Data waiving (study scientifically not necessary): According to REACH Annex VIII, column 2: In addition to the oral route, for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The information is provided for dermal route. Acute dermal toxicity: Key study: The LD50 of the test item is higher than 2000 mg/kg body weight by dermal route in rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19e20c9a-70c4-4538-8fc0-8443fc00f58d/documents/5ba5eaa4-7b57-4e4b-b0a4-3c57440cd8d2_59e2142e-eeab-4c0f-aba5-12464ae63242.html,,,,,, 2-[(1S)-4-methylcyclohex-3-en-1-yl]propan-2-ol,10482-56-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19e20c9a-70c4-4538-8fc0-8443fc00f58d/documents/5ba5eaa4-7b57-4e4b-b0a4-3c57440cd8d2_59e2142e-eeab-4c0f-aba5-12464ae63242.html,,oral,LD50,"2,830 mg/kg bw",no adverse effect observed, 2-[(1S)-4-methylcyclohex-3-en-1-yl]propan-2-ol,10482-56-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19e20c9a-70c4-4538-8fc0-8443fc00f58d/documents/5ba5eaa4-7b57-4e4b-b0a4-3c57440cd8d2_59e2142e-eeab-4c0f-aba5-12464ae63242.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "p-menthane-1,8-diol",80-53-5," - Oral route: The query structure was predicted as GHS category 5 in Leadscope using Acute Rat Oral Model v2 model. Estimated LD50 by oral route: 2500 mg/kg bw (QSAR prediction, K, Kr.2). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e300f24f-69d5-445b-a1c6-04f0959fb42f/documents/b61378c7-60f6-4b26-8747-fea5e19f61a1_6643194d-2e84-479a-ba86-25de6c5c0e73.html,,,,,, "p-menthane-1,8-diol",80-53-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e300f24f-69d5-445b-a1c6-04f0959fb42f/documents/b61378c7-60f6-4b26-8747-fea5e19f61a1_6643194d-2e84-479a-ba86-25de6c5c0e73.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "p-nitrobenzoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)",7394-38-9," There were no toxicologically significant changes in the examined parameters (clinical signs, body weight and body weight gain, food consumption, hematology, blood coagulation and clinical chemistry, necropsy findings, organ weights) after the 14-day oral (by gavage) administration of 100, 300 mg/kg bw/day doses. Main study OECD 422 in progress (05/2019), preliminary result available (NOAEL: 600 mg/ kg bw/d). Based on available data (no adverse effects observed in pre study OECD 407) the substance is not classified with repeated dose toxicity according to the CLP regulation 1272/2008/EC. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc518e45-847b-4095-9090-d4b5c621949b/documents/e0006884-a9d3-47e4-a865-da031184912a_c05640ed-423c-43de-aa3c-a978bec143c2.html,,,,,, "p-nitrobenzoic acid, compound with 2,2',2''-nitrilotriethanol (1:1)",7394-38-9," The acute oral median lethal dose (LD50) of p-Nitrobenzoic acid, compound with 2,2',2''-nitrilotriethanol (1:1) (CAS no. 7394-38-9), in the Sprague-Dawley Crl:CD® (SD) IGS BR strain rat, was estimated as being greater than 2500 mg/kg bodyweight. The test item is not classified with oral acute toxicity according to the CLP regulation 1272/2008/EC. The study concerning the acute inhalation toxicity does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. The study concerning the acute dermal toxicity does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitation). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc518e45-847b-4095-9090-d4b5c621949b/documents/7cdbf47b-ad8d-4758-9cf0-7bcba842a290_c05640ed-423c-43de-aa3c-a978bec143c2.html,,,,,, "p-nitrophenyl dihydrogen phosphate, compound with 2-amino-2-(hydroxymethyl)propane-1,3-diol (1:2)",68189-42-4," No study with 4-NPP, di -TRIS (CAS 68189-42-4) is available to draw a conclusion on its acute toxicity properties. Data from the analogues Tris (CAS 77-86-1) and 4-Nitrophenyl phosphate (4NPP, CAS 4264-83-9) was used on a read-across approach to fulfil this endpoint information requirement (See Read Across justification in Chapter 13). For the components of the substance 4-NPP, di -TRIS (CAS 68189-42-4), 4-Nitrophenyl phosphate (4NPP, CAS 4264-83-9) and Tris (CAS 77-86-1), there are reliable data available.  Acute toxicity data for Tris (CAS 77-86-1) is available from an oral gavage study with female mice. The acute oral toxicity of the substance was investigated in a GLP study according to OECD TG 425. The LD50 of the substance was determined as >5000 mg/kg bw. Acute toxicity data for 4-NPP (CAS 4264-83-9) is available from an oral gavage study with female mice. The acute oral toxicity of the substance was investigated in a GLP study according to OECD TG 423. The LD50 of the substance was determined as >300 - 2000 mg/kg bw.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75174e44-6af5-4e3c-99b3-6bb867a0ef62/documents/0f1da5b9-f8dd-4c0a-9a13-4e48f89ef90a_5e052b99-2bd6-4d9c-a6bf-018888ebed53.html,,,,,, "p-nitrophenyl dihydrogen phosphate, compound with 2-amino-2-(hydroxymethyl)propane-1,3-diol (1:2)",68189-42-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75174e44-6af5-4e3c-99b3-6bb867a0ef62/documents/0f1da5b9-f8dd-4c0a-9a13-4e48f89ef90a_5e052b99-2bd6-4d9c-a6bf-018888ebed53.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, p-nonylphenol,104-40-5,"Acute Oral Toxicity (Key study): The oral LD50 value for the test compound in male rats was calculated as 1475 mg/kg (95% confidence levels; upper 2406, lower 904). The LD50 (oral) for females appears to be similar to that for males. The study was performed according to OECD 401 (1987).   Acute Inhalation Toxicity: The test chemical is known to cause skin necrosis and is classified as skin corrosion 1B. In accordance with requirements of ANNEX VII column 2 of the REACH regulation, a study for acute inhalation need not be conducted, if the available information regarding skin irritation indicates that the criteria for classification as corrosive for the skin is met. Thus, this study was considered for waiver.   Acute Dermal Toxicity Male and female New Zealand white rabbits were given the undiluted test item at doses of 1260, 2000, 3160, 5010 and 7940 mg/kg of undiluted test chemical by application to the skin (treatment duration was 24 hours). The treated rabbits were observed for mortality and clinical signs of toxicity for 14 days post dosing. Gross necropsy was performed on each animal. No deaths were observed at 1260 or 2000 mg/kg, however all rabbits treated at 3160, 5010 and 7940 mg/kg died between 2-6 days post dosing. Weight loss was observed after one to three days in survivors. Necropsy findings of the dead rabbits showed lung hyperplasia, liver and kidney discoloration, enlarged gall bladder, spleen darkened and gastrointestinal inflammation. Based on the above observations the acute dermal LD50 was considered to be greater than 2000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b86ce6cb-8359-4ba7-b851-4a5c6833bfd2/documents/dede9076-5726-4917-bc7a-62cda711b8d8_96342f2b-4d53-49f5-8bfb-4bcbf904fe3b.html,,,,,, p-nonylphenol,104-40-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b86ce6cb-8359-4ba7-b851-4a5c6833bfd2/documents/dede9076-5726-4917-bc7a-62cda711b8d8_96342f2b-4d53-49f5-8bfb-4bcbf904fe3b.html,,oral,LD50,"1,475 mg/kg bw",adverse effect observed, p-nonylphenol,104-40-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b86ce6cb-8359-4ba7-b851-4a5c6833bfd2/documents/dede9076-5726-4917-bc7a-62cda711b8d8_96342f2b-4d53-49f5-8bfb-4bcbf904fe3b.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Poly (dipropyleneglycol) Phenyl phosphite,116265-68-0,TPP produced systemic toxicity at an oral dose of 40 mg/kg/day in a well conducted OECD 422 study which was extended and studied effects in F1 offspring treated to postpartum Day 70. The NOAEL in both the parental animals and the F1 offspring was 15 mg/kg/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2f9e27b-7815-431e-947f-1af7a913c2d3/documents/53f947d8-b315-49f1-a845-b61be785d0d9_475501a7-c4b9-43c1-aa6f-926994367a2f.html,,,,,, Poly (dipropyleneglycol) Phenyl phosphite,116265-68-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2f9e27b-7815-431e-947f-1af7a913c2d3/documents/53f947d8-b315-49f1-a845-b61be785d0d9_475501a7-c4b9-43c1-aa6f-926994367a2f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat Poly (dipropyleneglycol) Phenyl phosphite,116265-68-0, Acute oral toxicity in the rat ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2f9e27b-7815-431e-947f-1af7a913c2d3/documents/52dec9a5-c5eb-4a38-829a-a6a88dede32b_475501a7-c4b9-43c1-aa6f-926994367a2f.html,,,,,, Poly (dipropyleneglycol) Phenyl phosphite,116265-68-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2f9e27b-7815-431e-947f-1af7a913c2d3/documents/52dec9a5-c5eb-4a38-829a-a6a88dede32b_475501a7-c4b9-43c1-aa6f-926994367a2f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Poly(oxy-1,2-ethanediyl), α,α'-(iminodi-2,1-ethanediyl)bis[.omega.-hydroxy-, N-[3-(C10-16-alkyloxy)propyl] derivs., di-Et sulfate-quaternized",70983-58-3," The median lethal dose of the test item after a single oral administration to female rats, observed over a period of 14 days is: LD50 cut-off (rat): 500 mg/ kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/722d430f-7c9f-4076-8429-b3c8409c0ce6/documents/ccf4a3e8-015e-428d-aa60-fc4a5baa40d3_bfca9e1d-fba5-4729-b7c4-6ae8fcace894.html,,,,,, "Poly(oxy-1,2-ethanediyl), α,α'-(iminodi-2,1-ethanediyl)bis[.omega.-hydroxy-, N-[3-(C10-16-alkyloxy)propyl] derivs., di-Et sulfate-quaternized",70983-58-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/722d430f-7c9f-4076-8429-b3c8409c0ce6/documents/ccf4a3e8-015e-428d-aa60-fc4a5baa40d3_bfca9e1d-fba5-4729-b7c4-6ae8fcace894.html,,oral,discriminating dose,500 mg/kg bw,adverse effect observed, "Poly(oxy-1,2-ethanediyl), α-[2-(dide- cylmethylammonio)ethyl]- .omega.- hydroxy-, propanoate (salt) (Bardap 26)",94667-33-1,"The 90-day oral (diet) NOAEL of Bardap 26 in rats was 391 mg/kg bw/day The 90-day dermal NOAEL of Didecyldimethylammonium Chloride in rats was 14.9 mg/kg bw/d).The 8-week oral (gavage) NOAEL of Didecyldimethylammonium Chloride in dogs was 30 mg/kg bw/dThe 52-week oral (gavage) NOAEL of Didecyldimethylammonium Chloride in dogs was 10 mg a.s./kg bw/d (equivalent to 12.4 mg test substance/kg bw/d).The 104-week oral (diet) NOAEL of Didecyldimethylammonium Chloride in rats was 32 and 41 mg/kg bw/d for males and females, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8de8cdc-218d-4b65-84bc-2a23a824312a/documents/IUC5-2150e142-51fc-47c4-ae56-0a411c6c095d_ffb7fdf1-3575-41ed-a25c-3d5e0cd6269a.html,,,,,, "Poly(oxy-1,2-ethanediyl), α-[2-(dide- cylmethylammonio)ethyl]- .omega.- hydroxy-, propanoate (salt) (Bardap 26)",94667-33-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8de8cdc-218d-4b65-84bc-2a23a824312a/documents/IUC5-2150e142-51fc-47c4-ae56-0a411c6c095d_ffb7fdf1-3575-41ed-a25c-3d5e0cd6269a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,391 mg/kg bw/day,,rat "Poly(oxy-1,2-ethanediyl), α-[2-(dide- cylmethylammonio)ethyl]- .omega.- hydroxy-, propanoate (salt) (Bardap 26)",94667-33-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8de8cdc-218d-4b65-84bc-2a23a824312a/documents/IUC5-2150e142-51fc-47c4-ae56-0a411c6c095d_ffb7fdf1-3575-41ed-a25c-3d5e0cd6269a.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,14.9 mg/kg bw/day,,rat "Poly(oxy-1,2-ethanediyl), α-[2-(dide- cylmethylammonio)ethyl]- .omega.- hydroxy-, propanoate (salt) (Bardap 26)",94667-33-1,"The acute oral LD50 is 1157 mg/kg bw. The acute dermal LD50 of the read-across substance DDAC is 3342 mg a.s./kg bw, equivalent to 5.56 mL/kg bw test substance (assuming a density of 1). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8de8cdc-218d-4b65-84bc-2a23a824312a/documents/IUC5-ea1fee85-7dfd-4fe2-8f59-11c46442c593_ffb7fdf1-3575-41ed-a25c-3d5e0cd6269a.html,,,,,, "Poly(oxy-1,2-ethanediyl), α-[2-(dide- cylmethylammonio)ethyl]- .omega.- hydroxy-, propanoate (salt) (Bardap 26)",94667-33-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8de8cdc-218d-4b65-84bc-2a23a824312a/documents/IUC5-ea1fee85-7dfd-4fe2-8f59-11c46442c593_ffb7fdf1-3575-41ed-a25c-3d5e0cd6269a.html,,oral,LD50,"1,157 mg/kg bw",adverse effect observed, "Poly(oxy-1,2-ethanediyl), α-[2-(dide- cylmethylammonio)ethyl]- .omega.- hydroxy-, propanoate (salt) (Bardap 26)",94667-33-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8de8cdc-218d-4b65-84bc-2a23a824312a/documents/IUC5-ea1fee85-7dfd-4fe2-8f59-11c46442c593_ffb7fdf1-3575-41ed-a25c-3d5e0cd6269a.html,,dermal,LD50,"3,342 mg/kg bw",no adverse effect observed, "Poly(oxy-1,2-ethanediyl), α-butyl-ω-hydroxy-",9004-77-7," Oral LD50 data in rats: 1 study on the registered substance, LD50 >2000 mg/kg Dermal LD50 in rabbits >2000 mg/kg (on a compenant of the registered substance substance) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d99f031-bea7-4858-ae2c-913a59479156/documents/35ca0178-6195-441c-ac25-38a9a1ef6345_d10c58d8-5da1-4aa9-9365-99e316f2a1a5.html,,,,,, "Poly(oxy-1,2-ethanediyl), α-butyl-ω-hydroxy-",9004-77-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d99f031-bea7-4858-ae2c-913a59479156/documents/35ca0178-6195-441c-ac25-38a9a1ef6345_d10c58d8-5da1-4aa9-9365-99e316f2a1a5.html,,dermal,LD50,"3,540 mg/kg bw",, "Reaction mass of 2,2,5,8,12,15,15-heptamethyl-7,10-dioxa-4,13-diazahexadeca-3,13-diene-1,16-diyl didodecanoate and 2,2,5,8,12,15,18,18-octamethyl-7,10,13-trioxa-4,16-diazanonadeca-3,16-diene-1,19-diyl didodecanoate and 2,2,5,8,11,14,18,21,21-nonamethyl-7,10,13,16-tetraoxa-4,19-diazadocosa-3,19-diene-1,22-diyl didodecanoate",613246-75-6," Sika Hardener LJ caused no toxic effects in male and female CRL:(WI)BR rats after consecutive 28-day oral (gavage) administration of 50 mg/kg bw/day, 250 mg/kg bw/day and 1000 mg/kg bw/day doses according to OECD guideline 407 and EU method B.7. Therefore the No Observed Effect Level (NOEL) is 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4c2d06c-8a91-45ba-94be-f2cada66d7c3/documents/b9dcc23a-b3fe-44bb-9366-1be7df209c31_c1a77ab1-b0a3-4edc-bb69-4169b965e1cc.html,,,,,, "Reaction mass of 2,2,5,8,12,15,15-heptamethyl-7,10-dioxa-4,13-diazahexadeca-3,13-diene-1,16-diyl didodecanoate and 2,2,5,8,12,15,18,18-octamethyl-7,10,13-trioxa-4,16-diazanonadeca-3,16-diene-1,19-diyl didodecanoate and 2,2,5,8,11,14,18,21,21-nonamethyl-7,10,13,16-tetraoxa-4,19-diazadocosa-3,19-diene-1,22-diyl didodecanoate",613246-75-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f4c2d06c-8a91-45ba-94be-f2cada66d7c3/documents/b9dcc23a-b3fe-44bb-9366-1be7df209c31_c1a77ab1-b0a3-4edc-bb69-4169b965e1cc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Reaction mass of 2,2,5,8,12,15,15-heptamethyl-7,10-dioxa-4,13-diazahexadeca-3,13-diene-1,16-diyl didodecanoate and 2,2,5,8,12,15,18,18-octamethyl-7,10,13-trioxa-4,16-diazanonadeca-3,16-diene-1,19-diyl didodecanoate and 2,2,5,8,11,14,18,21,21-nonamethyl-7,10,13,16-tetraoxa-4,19-diazadocosa-3,19-diene-1,22-diyl didodecanoate",613246-75-6," Oral: The acute oral LD50 obtained for the test item was found to be greater 2000 mg/kg bw. Dermal: To assess the acute dermal toxicity of Sika Hardener LJ, read across was applied using toxicological data from the hydrolysis product 2,2-Dimethyl-3-lauroyloxy-propanal. Based on the findings of an acute dermal toxicity study, a single 24-hour dermal administration of the hydrolysis product did not induce any test item related adverse effects and a LD50 > 2000 mg/kg bw was derived. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4c2d06c-8a91-45ba-94be-f2cada66d7c3/documents/7383d62a-eaaa-42ed-8f58-01764dcc2725_c1a77ab1-b0a3-4edc-bb69-4169b965e1cc.html,,,,,, "Reaction mass of 2,2,5,8,12,15,15-heptamethyl-7,10-dioxa-4,13-diazahexadeca-3,13-diene-1,16-diyl didodecanoate and 2,2,5,8,12,15,18,18-octamethyl-7,10,13-trioxa-4,16-diazanonadeca-3,16-diene-1,19-diyl didodecanoate and 2,2,5,8,11,14,18,21,21-nonamethyl-7,10,13,16-tetraoxa-4,19-diazadocosa-3,19-diene-1,22-diyl didodecanoate",613246-75-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4c2d06c-8a91-45ba-94be-f2cada66d7c3/documents/7383d62a-eaaa-42ed-8f58-01764dcc2725_c1a77ab1-b0a3-4edc-bb69-4169b965e1cc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction mass of 2,2,5,8,12,15,15-heptamethyl-7,10-dioxa-4,13-diazahexadeca-3,13-diene-1,16-diyl didodecanoate and 2,2,5,8,12,15,18,18-octamethyl-7,10,13-trioxa-4,16-diazanonadeca-3,16-diene-1,19-diyl didodecanoate and 2,2,5,8,11,14,18,21,21-nonamethyl-7,10,13,16-tetraoxa-4,19-diazadocosa-3,19-diene-1,22-diyl didodecanoate",613246-75-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4c2d06c-8a91-45ba-94be-f2cada66d7c3/documents/7383d62a-eaaa-42ed-8f58-01764dcc2725_c1a77ab1-b0a3-4edc-bb69-4169b965e1cc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate",646505-36-4,"The subacute oral NOAEL (=NOEL) was determined with 300 mg/kg bw and day for male and female rats in this study based on local effects to the gastro-intestinal tract, and slight systemic effects in liver, thymus and lymph nodes seen at 1000 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76590033-f10b-4bf2-851f-5b0b53cca9d1/documents/IUC5-9a3ad227-dd05-421e-854b-2b429d5e5d67_4b72dabd-1ee6-49f3-ba96-b982b42797dc.html,,,,,, "Poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate",646505-36-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/76590033-f10b-4bf2-851f-5b0b53cca9d1/documents/IUC5-9a3ad227-dd05-421e-854b-2b429d5e5d67_4b72dabd-1ee6-49f3-ba96-b982b42797dc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate",646505-36-4,LD50 oral: > 2000 mg/kg bwLD50 dermal: > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76590033-f10b-4bf2-851f-5b0b53cca9d1/documents/IUC5-56fbf86b-735c-4600-b632-f2b38cef72f8_4b72dabd-1ee6-49f3-ba96-b982b42797dc.html,,,,,, "Poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate",646505-36-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76590033-f10b-4bf2-851f-5b0b53cca9d1/documents/IUC5-56fbf86b-735c-4600-b632-f2b38cef72f8_4b72dabd-1ee6-49f3-ba96-b982b42797dc.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Poly [oxy(methyl-1,2-ethanediyl)] , a -hydro-w -hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 3-[[3-dimethylamino) propyl]imino]butanoate",646505-36-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76590033-f10b-4bf2-851f-5b0b53cca9d1/documents/IUC5-56fbf86b-735c-4600-b632-f2b38cef72f8_4b72dabd-1ee6-49f3-ba96-b982b42797dc.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Poly[oxy(methyl-1,2-ethanediyl)], α-hydro-ω-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 2-propenoate",68890-85-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4488cb41-fc1e-448a-b02b-cc3187cccf09/documents/71bf28b4-27c3-4c45-9d72-dc912a17cc88_5debf043-7b0b-46ee-9f2c-189c4488c6bc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Poly[oxy(methyl-1,2-ethanediyl)], α-hydro-ω-hydroxy-, ether with 2-ethyl-2-(hydroxymethyl)-1,3-propanediol (3:1), 2-propenoate",68890-85-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4488cb41-fc1e-448a-b02b-cc3187cccf09/documents/4d90b373-eeb8-42fa-a075-69d4fa9025b8_5debf043-7b0b-46ee-9f2c-189c4488c6bc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction products of behenic acid, Eicosadioic acid and Polyglyceryl-10",457632-32-5," One Guideline Study available, The nominal dose applied is given as 200 mg/kg bw. However, a concentration in vehicle of 0.02 g/mL and a dosing volume of 20 mL/kg body weight is stated, resulting in a dose of 400 mg/kg bw. It is stated in the Notification according to 67/548/EWG that the reported dose is the maximal technically applicable dose due to low solubility of the test item. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6f4fc0e-82ef-4e7e-bbc4-5aed1e1c89f6/documents/1bea3a68-ae13-4f17-9561-8694f25b5b0a_7a20d8fd-729a-4f6f-afd3-b42406bdfd56.html,,,,,, "Reaction products of behenic acid, Eicosadioic acid and Polyglyceryl-10",457632-32-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6f4fc0e-82ef-4e7e-bbc4-5aed1e1c89f6/documents/1bea3a68-ae13-4f17-9561-8694f25b5b0a_7a20d8fd-729a-4f6f-afd3-b42406bdfd56.html,,oral,discriminating dose,200 mg/kg bw,no adverse effect observed, "Polymer with 2-Butyne-1,4-Diol and (Chloromethyl-)Oxirane, Brominated, Dehydrochlorinated, Methoxylated",86675-46-9," A 4-week inhalation toxicity study has been conducted with Polyol IXOL M125 in which rats were exposed for 6 hours/day, 5 days/week. The NOAEL for systemic effects of Polyol IXOL M125 was considered to be 290 mg/m3 for females and 950 mg/m3 for males. Since evidence of local toxicity in the upper respiratory tract was still found at this concentration, a NOAEC for local effects could not be established. Exposure to the structural analogue Polyol IXOL® B350 at concentrations up to 300 mg/m3 (the highest concentration tested) for 90 days, did not result in any treatment-related changes in the parameters tested. Therefore, the high concentration level of 300 mg/m3 was also considered to be the No-Observed-Adverse-Effect-Level (NOAEL) for systemic and local toxicity for Polyol IXOL M125. Based on read-across from the structural analogue Polyol IXOL B350, the most critical effect for IXOL M125 after repeated oral exposure are expected to be effects on the kidney. Oral exposure to Polyol IXOL B350 (OECD 443, GLP) at dosages of 0, 75, 150 and 450 mg/kg bw/day resulted in treatment-related adverse findings consisting of intratubular hemorrhage in the kidneys of F0 males administered 450 mg/kg/day and thyroid adenomas in F0 males adminstered ≥ 75 mg/kg/day, one female adminstered 450 mg/kg/day, and one F1 male administered 75 mg/kg/day. It should be noted that the relevance of such thyroid effects in rat studies - in quantitative terms - to humans is limited. Therefore the kidney effect is considered the most critical effect of Polyol IXOL B350 after repeated oral exposure. Based on the available study, the overall NOAEL for systemic effects is 150 mg/kg bw/day. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/159304b2-0ab7-4cd3-a7c2-7dce86b1f1ff/documents/aee1520a-c89c-430a-8691-129c74faa98d_ecf9e66b-651a-4f54-b005-d549fb40408f.html,,,,,, "Polymer with 2-Butyne-1,4-Diol and (Chloromethyl-)Oxirane, Brominated, Dehydrochlorinated, Methoxylated",86675-46-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/159304b2-0ab7-4cd3-a7c2-7dce86b1f1ff/documents/aee1520a-c89c-430a-8691-129c74faa98d_ecf9e66b-651a-4f54-b005-d549fb40408f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Polymer with 2-Butyne-1,4-Diol and (Chloromethyl-)Oxirane, Brominated, Dehydrochlorinated, Methoxylated",86675-46-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/159304b2-0ab7-4cd3-a7c2-7dce86b1f1ff/documents/aee1520a-c89c-430a-8691-129c74faa98d_ecf9e66b-651a-4f54-b005-d549fb40408f.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,300 mg/m3,,rat "Polymer with 2-Butyne-1,4-Diol and (Chloromethyl-)Oxirane, Brominated, Dehydrochlorinated, Methoxylated",86675-46-9,"The substance showed moderate acute oral toxicity in male rats with a LD50 of 917 mg/kg bw. In a range finding inhalation study, the LC50 was determined at >4900 mg/m3 for male and female rats. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/159304b2-0ab7-4cd3-a7c2-7dce86b1f1ff/documents/IUC5-a87412e8-39dc-4d30-93bd-c9d567879e3a_ecf9e66b-651a-4f54-b005-d549fb40408f.html,,,,,, "Polymer with 2-Butyne-1,4-Diol and (Chloromethyl-)Oxirane, Brominated, Dehydrochlorinated, Methoxylated",86675-46-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/159304b2-0ab7-4cd3-a7c2-7dce86b1f1ff/documents/IUC5-a87412e8-39dc-4d30-93bd-c9d567879e3a_ecf9e66b-651a-4f54-b005-d549fb40408f.html,,oral,LD50,917 mg/kg bw,, "Polymer with 2-Butyne-1,4-Diol and (Chloromethyl-)Oxirane, Brominated, Dehydrochlorinated, Methoxylated",86675-46-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/159304b2-0ab7-4cd3-a7c2-7dce86b1f1ff/documents/IUC5-a87412e8-39dc-4d30-93bd-c9d567879e3a_ecf9e66b-651a-4f54-b005-d549fb40408f.html,,inhalation,LC50,"4,900 mg/m3",, "Zinc, [[(1-methyl-1,2-ethanediyl)bis[carbamodithioato]](2-)]-, homopolymer",9016-72-2,"The key studies for repeated dose toxicity endpoints are as follows: 90-day oral (dietary) rat study (OECD 408 (1998), GLP, RL1), NOAEL (male) = 7.6 mg/kg bw/day, NOAEL (female) = 10.25 mg/kg bw/day (M-108777-01-1, Wirnitzer, 2003) 15-day dermal rabbit study (no guideline, pre-GLP, RL2), NOAEL = 250 mg/kg bw/day (M-116181-01-1, Mihail, 1979) 20-day inhalation rat study (OECD 412, GLP, RL1), NOAEC systemic = 3.97 mg/m³ (M-023867-01-1, Pauluhn, 2000) 28-day inhalation rat study (OECD 412, GLP, RL1), NOAEC local = 1.12 mg/m³ (M-039913-01-1, Pauluhn, 2001) The following supporting studies are available: 2-year oral (dietary) rat study (no guideline, pre-GLP, RL2), NOAEL = 0.46 mg/kg bw/day (M-050009-01-1, Loser, 1974) 90-day oral (dietary) dog study (OECD 409 (1981), GLP, RL1), NOAEL = 4.3 mg/kg bw/day (M-009667-01-1, Jones, 1999) 15-day inhalation rat study (no guideline, pre-GLP, RL2), NOAEC = 1.12 mg/m³ (M-062375-01-1, Thyssen, 1979).  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.6, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): The available information comprises adequate and reliable studies and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.6, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises adequate and reliable studies and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.6, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.6, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises adequate and reliable studies and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.6, of Regulation (EC) No 1907/2006. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ec13a9d-5925-4ccc-af60-ed96f56ab892/documents/d4bf610c-b51e-4c41-aa2b-4110327981bd_11dad507-a1ca-4f5b-90f1-3da7b5039677.html,,,,,, "Zinc, [[(1-methyl-1,2-ethanediyl)bis[carbamodithioato]](2-)]-, homopolymer",9016-72-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ec13a9d-5925-4ccc-af60-ed96f56ab892/documents/d4bf610c-b51e-4c41-aa2b-4110327981bd_11dad507-a1ca-4f5b-90f1-3da7b5039677.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,250 mg/kg bw/day,,rabbit "Zinc, [[(1-methyl-1,2-ethanediyl)bis[carbamodithioato]](2-)]-, homopolymer",9016-72-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ec13a9d-5925-4ccc-af60-ed96f56ab892/documents/d4bf610c-b51e-4c41-aa2b-4110327981bd_11dad507-a1ca-4f5b-90f1-3da7b5039677.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,3.97 mg/m3,,rat "Zinc, [[(1-methyl-1,2-ethanediyl)bis[carbamodithioato]](2-)]-, homopolymer",9016-72-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ec13a9d-5925-4ccc-af60-ed96f56ab892/documents/d4bf610c-b51e-4c41-aa2b-4110327981bd_11dad507-a1ca-4f5b-90f1-3da7b5039677.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,7.6 mg/kg bw/day,,rat "Zinc, [[(1-methyl-1,2-ethanediyl)bis[carbamodithioato]](2-)]-, homopolymer",9016-72-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ec13a9d-5925-4ccc-af60-ed96f56ab892/documents/d4bf610c-b51e-4c41-aa2b-4110327981bd_11dad507-a1ca-4f5b-90f1-3da7b5039677.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1.12 mg/m3,adverse effect observed,rat "Zinc, [[(1-methyl-1,2-ethanediyl)bis[carbamodithioato]](2-)]-, homopolymer",9016-72-2,"Reliable acute toxicity studies via oral, dermal and inhalation route are available. The test substance is not acutely toxic after oral or dermal exposure. However, it is harmful if inhaled. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate, reliable (Klimisch score 1-2) and consistent studies, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The available information comprises an adequate and reliable (Klimisch score 1) study and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The available information comprises adequate, reliable (Klimisch score 1-2) and consistent studies, and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ec13a9d-5925-4ccc-af60-ed96f56ab892/documents/dc39cb29-9d94-4945-8290-3572b8165692_11dad507-a1ca-4f5b-90f1-3da7b5039677.html,,,,,, "Polyphosphoric acids, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl esters",1802140-94-8," The oral LD50 of the read across substance was ≥2,000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebcd4cd4-45ec-4a23-a849-f1e0fa32051d/documents/IUC5-8b6a0428-9251-4241-abfc-a63c11b6a45d_be2d9edf-0f64-4bdb-9382-1c7862c248d2.html,,,,,, "Polyphosphoric acids, 2-[(2-methyl-1-oxo-2-propen-1-yl)oxy]ethyl esters",1802140-94-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebcd4cd4-45ec-4a23-a849-f1e0fa32051d/documents/IUC5-8b6a0428-9251-4241-abfc-a63c11b6a45d_be2d9edf-0f64-4bdb-9382-1c7862c248d2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Polyphosphoric acids, esters with triethanolamine, sodium salts",68131-72-6,"Polyphosphoric acids, esters with triethanolamine, sodium salts was administered in highly purified water as vehicle at dosages of 100, 500, and 1000 mg/kgbody weight/day, and controls received the vehicle only. Polyphosphoric acids, esters with triethanolamine, sodium salts was administered to male rats for 28 days and to female rats for 14 days prior to pairing, through the pairing and gestation periods until the F1 generation reached day 4 post partum.The NOEL (No Observed Effect Level) for general toxicity in males and females and for reproduction/developmental toxicity was considered to be1000 mg/kg bw day, the highest dose level used. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a61ade1d-1d86-482e-a6a3-5b523a8efae7/documents/IUC5-1e4160be-4a3a-4160-8fa3-9e400f2dc5d6_683f4658-13e8-4e78-9e67-2cd023654fb1.html,,,,,, "Polyphosphoric acids, esters with triethanolamine, sodium salts",68131-72-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a61ade1d-1d86-482e-a6a3-5b523a8efae7/documents/IUC5-1e4160be-4a3a-4160-8fa3-9e400f2dc5d6_683f4658-13e8-4e78-9e67-2cd023654fb1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Polyphosphoric acids, esters with triethanolamine, sodium salts",68131-72-6,Two acute oral toxicity studies (acute toxic class method) both estimated the LD50 in rats to be >2000 mg/kg bw.An acute dermal toxicity study (limit test) in the rat estimated the LD50 to be >2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a61ade1d-1d86-482e-a6a3-5b523a8efae7/documents/IUC5-f1c29e51-7f04-453b-969d-10bf49bce5d9_683f4658-13e8-4e78-9e67-2cd023654fb1.html,,,,,, "Polyphosphoric acids, esters with triethanolamine, sodium salts",68131-72-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a61ade1d-1d86-482e-a6a3-5b523a8efae7/documents/IUC5-f1c29e51-7f04-453b-969d-10bf49bce5d9_683f4658-13e8-4e78-9e67-2cd023654fb1.html,,oral,LD50,"2,000 mg/kg bw",, "Polyphosphoric acids, esters with triethanolamine, sodium salts",68131-72-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a61ade1d-1d86-482e-a6a3-5b523a8efae7/documents/IUC5-f1c29e51-7f04-453b-969d-10bf49bce5d9_683f4658-13e8-4e78-9e67-2cd023654fb1.html,,dermal,LD50,"2,000 mg/kg bw",, "Polysulfides, di-tert-Bu",68937-96-2,Acute Oral LD50 (rat) > 5000 mg/kg bw (Costello 1987)   ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a4e6aa8-f418-4357-a892-0fb258b478d8/documents/e1f86451-4580-481c-b7d6-8accac132134_eaf153b2-5d54-4cbc-b06c-3dc1555e54a5.html,,,,,, "Polysulfides, di-tert-Bu",68937-96-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a4e6aa8-f418-4357-a892-0fb258b478d8/documents/e1f86451-4580-481c-b7d6-8accac132134_eaf153b2-5d54-4cbc-b06c-3dc1555e54a5.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "Polysulfides, di-tert-dodecyl",68425-15-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study is considered to be reliable with a klimisch score of 1. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b791e2da-ecca-4066-8346-3a47db9929e6/documents/IUC5-35aa6072-b405-4846-99de-1bf3f93e2d4b_940b47fd-6b71-4a8f-a741-5a5b207f0a15.html,,,,,, "Polysulfides, di-tert-dodecyl",68425-15-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b791e2da-ecca-4066-8346-3a47db9929e6/documents/IUC5-35aa6072-b405-4846-99de-1bf3f93e2d4b_940b47fd-6b71-4a8f-a741-5a5b207f0a15.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Polysulfides, di-tert-dodecyl",68425-15-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b791e2da-ecca-4066-8346-3a47db9929e6/documents/IUC5-b424c24f-c3ef-4225-af00-b4bd3a3ea650_940b47fd-6b71-4a8f-a741-5a5b207f0a15.html,,oral,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, "Polysulfides, di-tert-dodecyl",68425-15-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b791e2da-ecca-4066-8346-3a47db9929e6/documents/IUC5-b424c24f-c3ef-4225-af00-b4bd3a3ea650_940b47fd-6b71-4a8f-a741-5a5b207f0a15.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Polysulfides, di-tert-nonyl",68425-16-1," In a key read across short-term oral repeat dose toxicity study (Molinier, 1995; Klimisch score = 1) Sprague-Dawley rats (6/sex/dose) were orally administered (via gavage) di-tert-dodecyl polysulfide (TPS 32) at doses of 50 or 250 mg/kg bw/day for four weeks. An additional 12 rats/sex/dose were similarly administered TPS at doses of 0 or 1000 mg/kg bw/day for a period of four weeks. On completion of the four-week exposure period, the first six surviving animals of each sex in the control and high dose group were kept for a two week recovery period.  No mortality was observed in male or female rats during the treatment or recovery periods. Ptyalism was observed in all animals that were treated at the 1000 mg/kg bw/day dose level. Body weight and food consumption was observed to be similar between animals in the treatment and control groups. Urinalysis, haematology, and clinical chemistry parameters appeared to be unaffected by exposure to TPS 32. No macroscopic abnormalities were observed and microscopic examinations did not reveal any significant treatment-related effects. Organ weights also appeared to be unaffected by treatment. Based on the lack of significant adverse treatment-related effects observed in this study, the NOAEL was determined to be 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4008070f-9a60-4f5d-84fa-33d8f009b8a6/documents/IUC5-c59a6472-1c38-4f31-bbeb-2fb389afad7b_276aa823-7393-4a4b-8207-88210c07d6cd.html,,,,,, "Polysulfides, di-tert-nonyl",68425-16-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4008070f-9a60-4f5d-84fa-33d8f009b8a6/documents/IUC5-c59a6472-1c38-4f31-bbeb-2fb389afad7b_276aa823-7393-4a4b-8207-88210c07d6cd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Polysulfides, di-tert-nonyl",68425-16-1," Key measured data were identified to evaluate the acute oral and inhalation toxicity potential of di-tert-nonyl polysulfide. Key read across data were identified to evaluate the acute dermal toxicity potential of di-tert-nonyl polysulfide. Key values are: • Acute oral LD50: 19,550 mg/kg bw • Acute inhalation LC50 (aerosol): >15.5 mg/L • Acute dermal LD50: >2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4008070f-9a60-4f5d-84fa-33d8f009b8a6/documents/IUC5-588402b2-bc76-45cc-8703-fe6523c536d5_276aa823-7393-4a4b-8207-88210c07d6cd.html,,,,,, "Polysulfides, di-tert-nonyl",68425-16-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4008070f-9a60-4f5d-84fa-33d8f009b8a6/documents/IUC5-588402b2-bc76-45cc-8703-fe6523c536d5_276aa823-7393-4a4b-8207-88210c07d6cd.html,,oral,LD50,"19,550 mg/kg bw",no adverse effect observed, "Polysulfides, di-tert-nonyl",68425-16-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4008070f-9a60-4f5d-84fa-33d8f009b8a6/documents/IUC5-588402b2-bc76-45cc-8703-fe6523c536d5_276aa823-7393-4a4b-8207-88210c07d6cd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Polysulfides, di-tert-nonyl",68425-16-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4008070f-9a60-4f5d-84fa-33d8f009b8a6/documents/IUC5-588402b2-bc76-45cc-8703-fe6523c536d5_276aa823-7393-4a4b-8207-88210c07d6cd.html,,inhalation,LC50,"15,500 mg/m3",no adverse effect observed, Potassium (R)-(4-hydroxyphenyl)[(3-methoxy-1-methyl-3-oxoprop-1-enyl)amino]acetate,69416-61-1,oral LD50 (male/female rats) > 2000 mg/kg bw (no mortality) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ec623d0-fbb0-4573-9ad1-6fa05be3eb59/documents/IUC5-3240811f-88f8-41d7-bf40-13371f73cb97_6f988907-0bef-4853-8f80-273a474e87ac.html,,,,,, Potassium (R)-[(3-ethoxy-1-methyl-3-oxoprop-1-enyl)amino]phenylacetate,961-69-3,"oral LD50 (rat, male, female) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7dfb65e-95c1-4d6b-be0d-9ec6212fd2d9/documents/IUC5-90daa5fa-81b4-41e0-8f20-caa342a9df0f_196bd1ca-6c7d-4207-b2ab-4e41fbdc7dce.html,,,,,, Potassium (Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate,76622-74-7," Repeated dose toxicity - oral (no OECD TG applied, 2-year study), rat: NOAEL ≥1000 mg/kg bw/day RA from source substance Sodium N-lauroylsarcosinate (CAS 137-16-6) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7078e18d-1db0-4ee5-8456-6de19295a450/documents/f4ad28b2-6733-4525-a27c-b1bc5f2c6b40_1272c63a-9b44-427b-a890-43989090bebf.html,,,,,, Potassium (Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate,76622-74-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7078e18d-1db0-4ee5-8456-6de19295a450/documents/f4ad28b2-6733-4525-a27c-b1bc5f2c6b40_1272c63a-9b44-427b-a890-43989090bebf.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Potassium (Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate,76622-74-7," Oral (OECD 401), rat: LD50 >5000 mg/kg bw RA from source substance (Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine (CAS 110-25-8) Inhalation (OECD 403), rat: LC50 = 1.37 mg/L air RA from source substance (Z)-N-methyl-N-(1-oxo-9-octadecenyl)glycine (CAS 110-25-8) Dermal (OECD 402), rat, LD50 > 2000 mg/kg bw RA from souce substances N-lauroylsarcosine (CAS 97-78-9), Sodium N-methyl-N-(1-oxotetradecyl)aminoacetate (CAS 30364-51-3) and Ammonium N-methyl-N-(1-oxododecyl)glycinate (CAS 68003-46-3) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7078e18d-1db0-4ee5-8456-6de19295a450/documents/dcd1fbc4-1169-43a3-bacf-baeb1a941d85_1272c63a-9b44-427b-a890-43989090bebf.html,,,,,, Potassium (Z)-N-methyl-N-(1-oxo-9-octadecenyl)aminoacetate,76622-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7078e18d-1db0-4ee5-8456-6de19295a450/documents/dcd1fbc4-1169-43a3-bacf-baeb1a941d85_1272c63a-9b44-427b-a890-43989090bebf.html,,inhalation,LC50,"1,370 mg/m3",adverse effect observed, "Potassium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']ferrate(1-)",54959-35-2,NOAEL is > 84 mg/kg bw/day for rats after 31/61 days of exposure via the food. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/826f48b8-e48b-4074-8680-cb42fb43af61/documents/IUC5-ae94bcd4-204c-4511-95c3-ba00ba539d4e_3b3c9067-8c22-42e4-96de-cbcef0323c74.html,,,,,, "Potassium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']ferrate(1-)",54959-35-2,"LD50 (oral, rat) exceeds 2000 mg/kg bwLD50 (dermal, rat) exceeds 2000 mg/kg bw (read across with ETD-FeNa)LC50 (rat, 4h) exceeded 2.75 +/- 0.19 mg/L, the maximum attainable concentration (read across with EDTA-FeNa). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/826f48b8-e48b-4074-8680-cb42fb43af61/documents/IUC5-24a2ae5e-9d26-4ebc-a339-780fb63d8976_3b3c9067-8c22-42e4-96de-cbcef0323c74.html,,,,,, potassium {[(2Z)-4-ethoxy-4-oxobut-2-en-2-yl]amino}acetate,71809-65-9," In an acute oral toxicity study in rats following OECD TG 423 (Acute Toxic Class method), the test substance was tested at the limit dose of 2000 mg/kg bw. Under the conditions of this study no clinical signs of toxicity and no mortality occurred. Therefore, the LD50 of this study is >2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a706c73-4021-4794-b33f-5688e754726c/documents/963eb722-75e5-4872-aa7c-ebafb8bba63c_835a050a-1d0e-4ff6-bfd4-c926b1d2d3a0.html,,,,,, potassium {[(2Z)-4-ethoxy-4-oxobut-2-en-2-yl]amino}acetate,71809-65-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a706c73-4021-4794-b33f-5688e754726c/documents/963eb722-75e5-4872-aa7c-ebafb8bba63c_835a050a-1d0e-4ff6-bfd4-c926b1d2d3a0.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate",29420-49-3," Five repeat dose studies were conducted with PFBSK+. The results of the studies were:   A 28 day oral gavage study in rats resulted in a NOAEL of 900 mg/kg/day when tested according to OECD 407.   A 30 day oral gavage study in rats resulted in a NOAEL of 1000 mg/kg/day when tested according to OECD 407.   A 90 day oral gavage study in rats resulted in a NOAEL of 200 mg/kg/day for males and 600 mg/kg/day for females when tested according to OECD 408.   A 10 day range finding study via oral gavage in rats resulted in a NOAEL of 1000 mg/kg/day.   Dietary PFBSK+ was administered for 6 weeks to male APOE*3, Leiden, CETP mice. At the end of the treatment, serum PFBS concentrations ranged between 32-38 ug/mL. PFBS treatment-related effects were limited to a decrease in serum triglyceride. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6c2de33-509a-4b72-9c90-e83f4e6ba1d3/documents/836234ca-241b-47ba-ba57-d78db1de0b85_3700bf14-96d7-456b-befa-b42462120e55.html,,,,,, "Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate",29420-49-3, Two acute oral toxicity and two acute dermal toxicity studies were conducted on PFBS K+.   The rat acute oral LD50is greater than 2000 mg/kg when tested according to OECD 401.   The rat acute oral LD50is greater than 2000 mg/kg when tested according to OECD 423.   The rat acute dermal LD50is greater than 2000 mg/kg when tested according to OECD 402.   The rat acute dermal LD50is greater than 2000 mg/kg when tested according to OECD 402. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6c2de33-509a-4b72-9c90-e83f4e6ba1d3/documents/cce1f1e7-32e9-47b4-9640-e1ab74bc9697_3700bf14-96d7-456b-befa-b42462120e55.html,,,,,, "Potassium 2',4'-difluoro-4-hydroxy[1,1'-biphenyl]-3-carboxylate",85665-84-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Data on the substance Diflunisal. Source: CHemID data base LD50 oral rat: 392 mg/kg LD50 oral mouse: 439 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b3b9d2c-ff45-47e7-ba7f-5a6c22f28016/documents/52c4bda9-9e03-4dcb-ab3d-d0dd79ab6b90_60d1f371-78a1-4b40-a3ef-b60d8d395d6e.html,,,,,, "Potassium 2',4'-difluoro-4-hydroxy[1,1'-biphenyl]-3-carboxylate",85665-84-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b3b9d2c-ff45-47e7-ba7f-5a6c22f28016/documents/52c4bda9-9e03-4dcb-ab3d-d0dd79ab6b90_60d1f371-78a1-4b40-a3ef-b60d8d395d6e.html,,oral,LD50,392 mg/kg bw,adverse effect observed, "Potassium 2,5-dihydroxybenzenesulphonate",21799-87-1, The toxicity studies for this substance did not exhibit any positive results. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/157bcc76-9289-4f38-9f0c-b17f3ca83738/documents/d65c9c38-5df8-4909-b367-b9b3b27f0ea9_e462cf20-02c9-4a2e-9576-7f5e09545f0e.html,,,,,, "Potassium 2,5-dihydroxybenzenesulphonate",21799-87-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/157bcc76-9289-4f38-9f0c-b17f3ca83738/documents/d65c9c38-5df8-4909-b367-b9b3b27f0ea9_e462cf20-02c9-4a2e-9576-7f5e09545f0e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Potassium 2-chloro-3-(benzyloxy)propionate,138666-92-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b89daa6a-2b1b-4156-b829-e9be9f23d45a/documents/535fce81-7486-4780-8295-5b98ab2e9cae_bb9b6c2e-d9c1-454b-8c3a-0cbd4ad6e45c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,, Potassium 2-chloro-3-(benzyloxy)propionate,138666-92-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b89daa6a-2b1b-4156-b829-e9be9f23d45a/documents/5a201133-8db3-4e57-a2ab-c3efba9f5d27_bb9b6c2e-d9c1-454b-8c3a-0cbd4ad6e45c.html,,oral,LD50,50 mg/kg bw,adverse effect observed, Potassium 2-ethylhexanoate,3164-85-0," No repeated dose toxicity study with potassium 2-ethylhexanoate is available, thus the repeated dose toxicity will be addressed with existing data on the assessment entities potassium and 2-ethylhexanoate. In relevant and reliable repeated dose toxicity studies for both assessment entities of potassium 2-ethylhexanoate, there were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/99f6c0b6-6074-47aa-95bb-0c70859fac5e/documents/IUC5-5a27c6f3-d3a7-46f0-a53f-7986e74af28b_ed228295-535d-40b2-acf6-ee4bddfdd17f.html,,,,,, Potassium 2-ethylhexanoate,3164-85-0," No acute toxicity studies with potassium 2-ethylhexanoate are available, thus the acute toxicity will be addressed with existing data on the dissociation products potassium and 2-ethylhexanoate. Signs of acute oral or acute dermal toxicity are not expected for potassium 2-ethylhexanoate, since the two assessment entities potassium and 2-ethylhexanoic acid have not shown signs of acute oral or acute dermal toxicity in experimental testing (both LD50 > 2000mg/kg). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99f6c0b6-6074-47aa-95bb-0c70859fac5e/documents/IUC5-25d71755-2ad2-4985-8971-3f93e1019e21_ed228295-535d-40b2-acf6-ee4bddfdd17f.html,,,,,, "Potassium 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonate",59587-38-1," Repeated dose toxicity study (OECD 422, Combined repeated dose toxicity study with the reproduction/developmental toxicity screening test): A systemic NOAEL was established at 15.0 mg/kg bw ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7783b95e-3ec5-4fbb-8c33-e9d86744ee3b/documents/77b1c32d-c249-440f-9bb1-d2792816c3f6_9e87b832-0d75-47ed-9f99-3847400e25e2.html,,,,,, "Potassium 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonate",59587-38-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7783b95e-3ec5-4fbb-8c33-e9d86744ee3b/documents/77b1c32d-c249-440f-9bb1-d2792816c3f6_9e87b832-0d75-47ed-9f99-3847400e25e2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "Potassium 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonate",59587-38-1," Acute oral toxicity (OECD 420, fixed dose method): LD50 between 300 and 2000 mg/kg bw Acute dermal toxicitity (OECD 402, acute dermal toxicity): The LD50 was determined to be higher than 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7783b95e-3ec5-4fbb-8c33-e9d86744ee3b/documents/949a3aa6-e2ac-48fa-b99c-831cb63fd245_9e87b832-0d75-47ed-9f99-3847400e25e2.html,,,,,, "Potassium 3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctanesulphonate",59587-38-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7783b95e-3ec5-4fbb-8c33-e9d86744ee3b/documents/949a3aa6-e2ac-48fa-b99c-831cb63fd245_9e87b832-0d75-47ed-9f99-3847400e25e2.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Potassium 3-sulphopropyl methacrylate,31098-21-2," Repeated dose toxicity: Subacute (ca. 6 weeks) study oral (gavage), rat (Wistar) m/f, read-across from 2-Propenoic acid, 3-sulfopropyl ester, potassium salt (OECD 422, GLP): NOAEL = 1000 mg/kg bw/d ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e1da4b6-ad68-45ae-8c65-f363e3953639/documents/1513119c-a62e-469c-81e7-77c13e81bf59_6942c6a1-b63d-4bd4-aa7a-461985aa05a0.html,,,,,, Potassium 3-sulphopropyl methacrylate,31098-21-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e1da4b6-ad68-45ae-8c65-f363e3953639/documents/1513119c-a62e-469c-81e7-77c13e81bf59_6942c6a1-b63d-4bd4-aa7a-461985aa05a0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Potassium 3-sulphopropyl methacrylate,31098-21-2," Acute toxicity oral: Acute study oral (gavage), rat (Wistar) m/f (OECD 401, GLP): LD50 > 5000 mg/kg, LD0 >= 5000 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e1da4b6-ad68-45ae-8c65-f363e3953639/documents/e481633e-4a06-48ac-9622-ed1b1366568c_6942c6a1-b63d-4bd4-aa7a-461985aa05a0.html,,,,,, Potassium 3-sulphopropyl methacrylate,31098-21-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e1da4b6-ad68-45ae-8c65-f363e3953639/documents/e481633e-4a06-48ac-9622-ed1b1366568c_6942c6a1-b63d-4bd4-aa7a-461985aa05a0.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Potassium 4-acetoacetylaminobenzenesulphonate,70321-85-6,ACUTE ORAL TOXICITY:A study was carried out equivalent or similar to EU Method B.1 and OECD Guideline 401 (Acute oral toxicity). The acute oral median lethal dose (LD50) of the test item in the rat was found to be > 5000 mg/kg.ACUTE DERMAL TOXICITY:A study was carried out according to EU Method B.3 and OECD Guideline 402 (Acute dermal toxicity). The acute dermal median lethal dose (LD50) of the test item in the rat was found to be > 2000 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d24c8167-1a04-43cb-b9c9-74b73146ec19/documents/IUC5-59268e4e-0717-468c-9e57-a70e4b08519f_7b46fade-53e3-4395-bd9e-9ce873e96793.html,,,,,, Potassium 4-acetoacetylaminobenzenesulphonate,70321-85-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d24c8167-1a04-43cb-b9c9-74b73146ec19/documents/IUC5-59268e4e-0717-468c-9e57-a70e4b08519f_7b46fade-53e3-4395-bd9e-9ce873e96793.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Potassium 4-acetoacetylaminobenzenesulphonate,70321-85-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d24c8167-1a04-43cb-b9c9-74b73146ec19/documents/IUC5-59268e4e-0717-468c-9e57-a70e4b08519f_7b46fade-53e3-4395-bd9e-9ce873e96793.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Potassium carbamoylcarbamate,26479-35-6,"According to the read-across strategy document as provided as an attachment to this Chemical Safety Report (CSR), potassium allophonate quickly hydrolyses to urea under physiological conditions. Therefore, the repeated-dose systemic toxicity of potassium allophonate was evaluated based on read-across from appropriate studies on urea. The highest quality repeated-dose study available on urea is a 12-month oral carcinogenicity/chronic toxicity screening assay, in which F-344 rats and C57BL/6 mice (50/sex/group) were exposed to urea in the diet at concentrations of 4500, 9000 or 45,000 ppm for 12 months. Chronic administration of urea to rats and mice in their feed produced no dose-dependent, biologically significant chronic or carcinogenic effects that could be clearly attributable to the test substance. For purposes of derivation of DNELs for potassium allophonate, the lowest NOAEL from the one-year urea study is used (3786 mg/kg/day for male rats). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Reliable with restrictions ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff854c66-ff83-4d86-8b8a-7620f8c19dbb/documents/cf9712ab-f431-44ba-bd05-4956d1c6b7a7_d1522770-579b-4856-94b2-a905bbcf9643.html,,,,,, Potassium carbamoylcarbamate,26479-35-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ff854c66-ff83-4d86-8b8a-7620f8c19dbb/documents/cf9712ab-f431-44ba-bd05-4956d1c6b7a7_d1522770-579b-4856-94b2-a905bbcf9643.html,Chronic toxicity – systemic effects,oral,NOAEL,"3,786 mg/kg bw/day",,rat Potassium carbamoylcarbamate,26479-35-6,"Potassium allophonate was evaluated for acute toxicity via the oral, inhalation and dermal routes in studies using standard methodology. These studies indicate a low potential for acute toxicity when administered through oral, inhalation, or dermal routes. Based on the available data, the oral LD50 was greater than 2000 mg/kg in female rats (OECD Testing Guideline 423) and the dermal LD50 was greater than 2000 mg/kg (OECD Testing Guideline 402). For acute Inhalation toxicity in rats (OECD Testing Guideline 436), the LC50 value is greater than 2.26 mg/L, which was the highest achievable aerosol concentration under the study conditions. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable without restriction Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Reliable without restriction. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Reliable without restriction. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff854c66-ff83-4d86-8b8a-7620f8c19dbb/documents/9e181b8e-5e7c-4d35-b7df-417992d9b941_d1522770-579b-4856-94b2-a905bbcf9643.html,,,,,, Potassium carbamoylcarbamate,26479-35-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff854c66-ff83-4d86-8b8a-7620f8c19dbb/documents/9e181b8e-5e7c-4d35-b7df-417992d9b941_d1522770-579b-4856-94b2-a905bbcf9643.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Potassium carbamoylcarbamate,26479-35-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff854c66-ff83-4d86-8b8a-7620f8c19dbb/documents/9e181b8e-5e7c-4d35-b7df-417992d9b941_d1522770-579b-4856-94b2-a905bbcf9643.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Potassium carbamoylcarbamate,26479-35-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ff854c66-ff83-4d86-8b8a-7620f8c19dbb/documents/9e181b8e-5e7c-4d35-b7df-417992d9b941_d1522770-579b-4856-94b2-a905bbcf9643.html,,inhalation,LC50,"2,260 mg/m3",no adverse effect observed, Potassium dicyanoargentate,506-61-6," Repeat dose oral toxicity study in rats to test guideline OECD422 standard. Animals were treated daily at dose levels of 1, 3 and 10 mg/kg/day for a total of 29 days for males and 42-46 days for females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1183f7d1-6c68-4748-87df-6da4ba84b745/documents/de305dd5-4a3b-419d-925e-27b861136d48_030f5ea8-f913-485e-a2ee-ee80cd8263fc.html,,,,,, Potassium dicyanoargentate,506-61-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1183f7d1-6c68-4748-87df-6da4ba84b745/documents/de305dd5-4a3b-419d-925e-27b861136d48_030f5ea8-f913-485e-a2ee-ee80cd8263fc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Potassium dicyanoargentate,506-61-6," Acute toxicity studies by oral, inhalation and dermal routes of administration were waived on the basis of the positive results in the in vitro human epidermis (he-EpiDerm) conducted in accordance with OECD431 test guideline and in vitro eye irritation test (BCOP) conducted in accordance with OECD437 test guideline, or as a consequence of the low respirable fraction and large particle size determined in dustiness testing. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1183f7d1-6c68-4748-87df-6da4ba84b745/documents/2c8a15ff-331b-4663-8689-db91bd31ae32_030f5ea8-f913-485e-a2ee-ee80cd8263fc.html,,,,,, Potassium dicyanoaurate,13967-50-5,"Repeat dose oral toxicity study in rats to test guideline OECD422 standard. Animals were treated daily at dose levels of 1, 3 and 10 mg/kg/day for a total of 35 days for males and 43 days for females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/575d4520-d0fe-497a-8703-ffeaf43e4228/documents/IUC5-1ee152ae-f9d6-4c6c-b803-256497a09960_39df085c-ee2e-4823-8585-655efe6394dc.html,,,,,, Potassium dicyanoaurate,13967-50-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/575d4520-d0fe-497a-8703-ffeaf43e4228/documents/IUC5-1ee152ae-f9d6-4c6c-b803-256497a09960_39df085c-ee2e-4823-8585-655efe6394dc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,3 mg/kg bw/day,,rat Potassium dicyanoaurate,13967-50-5,"Acute oral toxicity study in rats by the procedure according to OECD401 guideline.Acute dermal toxicity study in rats, limit dose procedure according to OECD402 guideline. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/575d4520-d0fe-497a-8703-ffeaf43e4228/documents/IUC5-25e9f671-10d5-4155-a36a-729fe005944e_39df085c-ee2e-4823-8585-655efe6394dc.html,,,,,, Potassium dicyanoaurate,13967-50-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/575d4520-d0fe-497a-8703-ffeaf43e4228/documents/IUC5-25e9f671-10d5-4155-a36a-729fe005944e_39df085c-ee2e-4823-8585-655efe6394dc.html,,oral,LD50,29.2 mg/kg bw,adverse effect observed, Potassium dimethyl 5-sulphonatoisophthalate,10433-41-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2b5f92c-42d3-4642-9bb6-9f35dc7a79d8/documents/2a430dc8-2779-466a-bd4d-fa0d6b13e980_0659ead1-647f-4f64-a2f3-f5bd6f86ce44.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Potassium dimethyldithiocarbamate,128-03-0,see study records ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/781ef424-1850-48fe-aa0d-b6dfb852b009/documents/IUC5-1d5ba96c-1483-44c9-8266-37939693b9ee_326c0eef-ba1f-4238-833e-dbaa1e652be4.html,,,,,, Potassium dimethyldithiocarbamate,128-03-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/781ef424-1850-48fe-aa0d-b6dfb852b009/documents/IUC5-1d5ba96c-1483-44c9-8266-37939693b9ee_326c0eef-ba1f-4238-833e-dbaa1e652be4.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,226 mg/kg bw/day,,rabbit Potassium dimethyldithiocarbamate,128-03-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/781ef424-1850-48fe-aa0d-b6dfb852b009/documents/IUC5-1d5ba96c-1483-44c9-8266-37939693b9ee_326c0eef-ba1f-4238-833e-dbaa1e652be4.html,Chronic toxicity – systemic effects,oral,NOAEL,3.33 mg/kg bw/day,,dog Potassium dimethyldithiocarbamate,128-03-0,Non-toxic via oral and dermal route. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/781ef424-1850-48fe-aa0d-b6dfb852b009/documents/IUC5-bc0188fc-1a52-436d-885c-875e10480b75_326c0eef-ba1f-4238-833e-dbaa1e652be4.html,,,,,, Potassium dimethyldithiocarbamate,128-03-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/781ef424-1850-48fe-aa0d-b6dfb852b009/documents/IUC5-bc0188fc-1a52-436d-885c-875e10480b75_326c0eef-ba1f-4238-833e-dbaa1e652be4.html,,oral,LD50,"2,030 mg/kg bw",, Potassium dimethyldithiocarbamate,128-03-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/781ef424-1850-48fe-aa0d-b6dfb852b009/documents/IUC5-bc0188fc-1a52-436d-885c-875e10480b75_326c0eef-ba1f-4238-833e-dbaa1e652be4.html,,dermal,LD50,"2,000 mg/kg bw",, Potassium ethanolate,917-58-8,Read across to ethanol (CAS No. 64-17-5) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2b4c4553-2b95-46d3-89f4-30999298e2e9/documents/IUC5-43266e3a-bf95-40d3-bdaa-f9851d1edec3_df287272-1ef9-4563-89aa-08bef9ae489a.html,,,,,, Potassium ethanolate,917-58-8,No study on acute toxicity was conducted due to the corrosive character of the test substance. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b4c4553-2b95-46d3-89f4-30999298e2e9/documents/IUC5-c86aa43a-3b3b-463c-bbf2-58d5c4a9a272_df287272-1ef9-4563-89aa-08bef9ae489a.html,,,,,, potassium ferrite,12160-44-0,"Based on the results obtained in the 28 day repeated dose toxicity study by gavage, the NOAEL was determined to be 500 mg/kg/bw for male and female rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d74e79b-56e1-4417-85ef-1d46922c1c85/documents/IUC5-7b453619-b142-4779-a243-a96f085074a9_394c9f09-4e77-444d-84d2-e6f83ffeb090.html,,,,,, potassium ferrite,12160-44-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d74e79b-56e1-4417-85ef-1d46922c1c85/documents/IUC5-7b453619-b142-4779-a243-a96f085074a9_394c9f09-4e77-444d-84d2-e6f83ffeb090.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat potassium ferrite,12160-44-0,An LD50 of >2000mg/kg bw was observed in both the acute oral and acute dermal toxicity study. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d74e79b-56e1-4417-85ef-1d46922c1c85/documents/IUC5-c3b2b153-3257-4ce5-a6ce-d9e32da6a0ff_394c9f09-4e77-444d-84d2-e6f83ffeb090.html,,,,,, potassium ferrite,12160-44-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d74e79b-56e1-4417-85ef-1d46922c1c85/documents/IUC5-c3b2b153-3257-4ce5-a6ce-d9e32da6a0ff_394c9f09-4e77-444d-84d2-e6f83ffeb090.html,,oral,LD50,"2,000 mg/kg bw",, potassium ferrite,12160-44-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d74e79b-56e1-4417-85ef-1d46922c1c85/documents/IUC5-c3b2b153-3257-4ce5-a6ce-d9e32da6a0ff_394c9f09-4e77-444d-84d2-e6f83ffeb090.html,,dermal,LD50,"2,000 mg/kg bw",, Potassium formate,590-29-4,"No potassium formate repeated dose study is known to exist for any route of exposure, but read across to other formate salts can be made. Regarding the most relevant oral route, the systemic toxicity of potassium diformate was low in a subchronic study (NOAEL 3000 mg/kg bw/day). Taking formula weights and stoichiometry into account, the subchronic NOAEL was 3877 mg/kg bw/day for the systemic toxicity of sodium formate in the rat. There was no target organ except the stomach which showed local irritation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a86bddf8-db99-4c09-bcf9-081a3ddbad66/documents/45ed6381-7926-46e2-a05c-3a758b2be945_fa80b073-864d-4012-9fbc-5b286a0a03c8.html,,,,,, Potassium formate,590-29-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a86bddf8-db99-4c09-bcf9-081a3ddbad66/documents/45ed6381-7926-46e2-a05c-3a758b2be945_fa80b073-864d-4012-9fbc-5b286a0a03c8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,877 mg/kg bw/day",,rat Potassium formate,590-29-4,"Potassium formate is of low acute toxicity (LD50, mouse > 5000 mg/kg). Inhalation and dermal data are lacking but can be read across (dermal LD50 >2000 mg/kg bw; LC50 >0.83 mg/L [corrected for formula weight]) from sodium formate (cf. data below) because differences between the two alkali metals are considered to be negligible. Sodium formate data: the acute oral and dermal toxicity is low (LD50 values in rodents >2000 mg/kg). Inhalation is not considered to represent a relevant route of exposure, because formate salts are solids with a very low vapour pressure. Consequently only few inhalation studies are available. The maximal attainable dust concentration of 0.67 mg sodium formate/L (rats, 4 hours) produced no signs of toxicity. The LC50 was therefore >0.67 mg/L in the sole available inhalation study. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a86bddf8-db99-4c09-bcf9-081a3ddbad66/documents/4e5f2e0d-a746-4302-a548-cd8c29a830c6_fa80b073-864d-4012-9fbc-5b286a0a03c8.html,,,,,, Potassium formate,590-29-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a86bddf8-db99-4c09-bcf9-081a3ddbad66/documents/4e5f2e0d-a746-4302-a548-cd8c29a830c6_fa80b073-864d-4012-9fbc-5b286a0a03c8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Potassium formate,590-29-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a86bddf8-db99-4c09-bcf9-081a3ddbad66/documents/4e5f2e0d-a746-4302-a548-cd8c29a830c6_fa80b073-864d-4012-9fbc-5b286a0a03c8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Potassium formate,590-29-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a86bddf8-db99-4c09-bcf9-081a3ddbad66/documents/4e5f2e0d-a746-4302-a548-cd8c29a830c6_fa80b073-864d-4012-9fbc-5b286a0a03c8.html,,inhalation,LC50,830 mg/m3,no adverse effect observed, Potassium hexahydroxoantimonate,12208-13-8,"No test item related changes were observed in a 90-day repeated dose toxicity study via oral route up to the limit dose of 1000 mg/kg bw/day with sodium hexahydroxoantimonate. The no-observed-effect level (NOEL) was above 1000 mg sodium hexahydroxoantimonate/kg b.w./day, p.o. for the male and female rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/647d2d4e-9c71-4013-a749-58d8df97a073/documents/84b36cd1-3a04-4f10-a307-c96e5c356a56_5b60d8bb-2716-4c96-b66b-6e36dd229a0f.html,,,,,, Potassium hexahydroxoantimonate,12208-13-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/647d2d4e-9c71-4013-a749-58d8df97a073/documents/84b36cd1-3a04-4f10-a307-c96e5c356a56_5b60d8bb-2716-4c96-b66b-6e36dd229a0f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Potassium hexahydroxoantimonate,12208-13-8,"Acute toxicity, oral:LD50 > 2000 mg/kg bwAcute toxicity, inhalation:LC50 > 5.40 mg sodium hexahydroxoantimonate/L airBased on the results of the histopathological and macroscopic investigations, sodium hexahydroxoantimonate does not require classification for respiratory irritation. Acute toxicity, dermal:Conduct of an acute dermal toxicity study is unjustified as inhalation of the substance is considered as major route of exposure and physicochemical properties of the substance do not suggest a significant rate of absorption through the skin (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/647d2d4e-9c71-4013-a749-58d8df97a073/documents/fc9bb48c-6d27-4404-bda6-13f2f794b634_5b60d8bb-2716-4c96-b66b-6e36dd229a0f.html,,,,,, Potassium hydrogendifluoride,7789-29-9,"The toxicity of potassium hydrogen difluoride will be dominated by local (site of contact) effects, as a consequence of its corrosive nature. Systemic expousre is likely to be limited, but systemic toxicity is predicted to be due to fluoride and the critical effect will be skeletal fluorosis. Comprehensive repeated dose oral toxicity data are available for sodium fluoride; read-across is therefore proposed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3161f3f8-fdb2-4f02-bb11-da77b21726af/documents/IUC5-18b78131-a3d7-4a05-93ef-6f0efb856c92_34be2c44-c3fb-43f8-aa36-7b8085144e32.html,,,,,, Potassium hydrogendifluoride,7789-29-9,"Waivers are appropriate for acute oral, dermal and inhalation toxicity as potassium hydrogen difluoride is a corrosive substance and additionally is already classified as Toxic if swallowed (H301) under CLP. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3161f3f8-fdb2-4f02-bb11-da77b21726af/documents/IUC5-d09c596d-85bd-498e-b346-733c443ab18a_34be2c44-c3fb-43f8-aa36-7b8085144e32.html,,,,,, Potassium hydrogensulphate,7646-93-7," Read-across conclusions for the following properties under consideration The basis for the read-across concept for this project is the equilibrium between sulfates, hydrogensulfates, and sulfuric acid in aqueous solutions depending on pH value which is clearly described in published literature and summarised in the following equations: H2SO4<-> HSO4-+ H+      HSO4-<-> H++ SO42- As the nature of the cation should make no significant difference in this case concerning toxicity and solubility (all compounds are very soluble in water), only the chemical and biological properties of the anion are considered relevant. Based on the described equilibrium correlations, we propose unrestricted read-across between the groups of sulfates, hydrogensulfates and sulfuric acid concerning systemic toxicity.   The proposed read-across concept only applies to toxicological and ecotoxicological/environmental fate endpoints. Test results are available for sodium sulfate and sulfuric acid for acute toxicity rat (oral). Sodium sulfate: LD50 (rat,oral) > 2000 mg/kg bw (Areclin) LD50 (rat, oral) > 10 g/kg bw (Henkel) Sulfuric acid: LD50 2140 mg/kg bw Based on the assumption described in the read-across concept, read-across from sodium sulfate and sulfuric acid to potassium hydrogensulfate is considered justified. Threfore it can be concluded that potassium hydrogensulfate has no acute-toxic propoerties. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e07993b3-506a-489b-9b2e-bc3d8a26e7d1/documents/4188bf33-ff7c-4f45-8582-2dfac15a911a_437fbc9e-af5a-454f-aa60-6318e73ff281.html,,,,,, Potassium hydroxyoctaoxodizincatedichromate(1-),11103-86-9,There are no non-human data on repeated dose effects of zinc potassium chromate. Read-across from sparingly water soluble chromates and from highly water soluble chromates are suggested. Human evidence in several studies with highly water soluble chromates show irritant and corrosive responses in relation to inhalation and dermal exposure. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5dfe2f55-3ba2-4bf2-90fe-9864b8d86cc1/documents/IUC5-692088a6-071a-4a79-a9eb-f14a44f0bc19_fadafe96-3670-46ae-81f9-a92a3986bb2a.html,,,,,, Potassium hydroxyoctaoxodizincatedichromate(1-),11103-86-9,"A valid test on acute inhalation toxicity of another sparingly water soluble chromate, strontium chromate, exists and is utilised for read-across. In acute oral toxicity, a poorly described study on strontium chromate is notified but the LD50 is based on read-across from a sparingly water soluble chromate. There is no non-human information on acute dermal toxicity of zinc potassium chromate. Human information on zinc potassium chromate is also lacking. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5dfe2f55-3ba2-4bf2-90fe-9864b8d86cc1/documents/IUC5-0637229a-8c1a-425d-8f10-1d2009e4afaa_fadafe96-3670-46ae-81f9-a92a3986bb2a.html,,,,,, Potassium hydroxyoctaoxodizincatedichromate(1-),11103-86-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5dfe2f55-3ba2-4bf2-90fe-9864b8d86cc1/documents/IUC5-0637229a-8c1a-425d-8f10-1d2009e4afaa_fadafe96-3670-46ae-81f9-a92a3986bb2a.html,,oral,LD50,327 mg/kg bw,, Potassium hydroxyoctaoxodizincatedichromate(1-),11103-86-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5dfe2f55-3ba2-4bf2-90fe-9864b8d86cc1/documents/IUC5-0637229a-8c1a-425d-8f10-1d2009e4afaa_fadafe96-3670-46ae-81f9-a92a3986bb2a.html,,inhalation,LC50,270 mg/m3,, Potassium iodate,7758-05-6,"Repeated dose toxicity: Oral   The study was designed to investigate the subacute repeated dose toxicity effects of the test chemical to Beltsville guinea pigs(male/female) by oral route in an overall estimation period of 28 days. First group (6 animals per sex in each dose group) was fed a dry Purina Rabbit Chow in the drinking water equivalent to 12.5 mg/kg bw/day (0.05 % concentration) test chemical in the diet. The second group received only the test chemical equivalent to125 mg/kg bw/day (0.50 % concentration), and the third group as control received distilled water. During the study period body weight, haematology, histopathology, opthalmoscopic examination, gross pathology, water consumption, total body weight and compound intake were examined. The blood examinations failed to show any striking changes related to the target compound. All animals remained in good physical condition during the 4-week study period. No gross changes were observed on postmortem examination and no retinal degeneration or other significant histologic changes were noted. Thus from overall dissussion of the study, the NOAEL (no observed adverse effect level) for repeated dose oral toxicity was considered to be 125 mg/kg bw/day.   Repeated dose toxicity: Inhalation   The test substance Potassium iodate has very low vapor pressure (6.82E-19 Pa) also the particle size distribution of the substance was found to vary in the size of 150 µm to 500 µm, so the potential for the generation of inhalable vapours of Potassium iodate is low. Moreover the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur and therefore repeated dose toxicity via the inhalation route was considered for waiver.   Repeated dose toxicity : Dermal   The results for acute toxicity by the dermal route indicate the LD50 value to be greater than 2000 mg/kg body weight. In addition, skin contact in production and/or use is likely but can be avoided by wearing the protective equipemt such as gloves during handling and the physicochemical and toxicological properties suggest no potential for significant rate of adsorption through the skin. Thus, given the above considerations, it is assumed that Potassium iodate shall not exhibit repeated dose toxicity by the dermal route.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4280a76-ce66-4afc-9f07-6f6ed813d7c5/documents/e04dd34a-7c85-4ee1-904c-12b7043aa9d2_1acf583e-bd8e-44ed-b6d4-2a1bb139007f.html,,,,,, Potassium iodate,7758-05-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4280a76-ce66-4afc-9f07-6f6ed813d7c5/documents/e04dd34a-7c85-4ee1-904c-12b7043aa9d2_1acf583e-bd8e-44ed-b6d4-2a1bb139007f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,guinea pig Potassium iodate,7758-05-6,"Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute oral toxicity class IV.   Acute Inhalation Toxicity:   The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 6.82E-19 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity:   The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4280a76-ce66-4afc-9f07-6f6ed813d7c5/documents/75dca41e-b36c-431f-932a-7c70fb0bbbc3_1acf583e-bd8e-44ed-b6d4-2a1bb139007f.html,,,,,, Potassium iodate,7758-05-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4280a76-ce66-4afc-9f07-6f6ed813d7c5/documents/75dca41e-b36c-431f-932a-7c70fb0bbbc3_1acf583e-bd8e-44ed-b6d4-2a1bb139007f.html,,oral,LD50,513 mg/kg bw,no adverse effect observed, Potassium iodate,7758-05-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4280a76-ce66-4afc-9f07-6f6ed813d7c5/documents/75dca41e-b36c-431f-932a-7c70fb0bbbc3_1acf583e-bd8e-44ed-b6d4-2a1bb139007f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Potassium isobutyrate,19455-20-0, One key study is available for the endpoint acute oral toxicity. This study is performed in accordance with OECD 423 and under the conditions of GLP. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28d7913d-a9cd-4082-a2dc-524e11972e1e/documents/95322bc1-6d7a-456e-ba59-cac921248eec_fd933bb0-ba4a-46b6-b16c-02bc887e9023.html,,,,,, Potassium isopentyl dithiocarbonate,928-70-1,"PIAX (Potassium IsoAmyl Xanthate, Potassium 3-methylbutoxymethanedithioate, Potassium Isopentyl dithiocarbonate, EC 213-180-2, CAS 928-70-1) belongs to the group of organic salts (xanthate salts) formed by the treatment of the relevant alcohol (ROH) and carbon disulphide (CS2) in the presence of an alkali. Xanthate salts are unstable chemical compounds and decompose in aqueous solutions. This decomposition can undergo several reaction mechanisms (Laura Ferrando Climent, 2020),(P. Donato, 1989), and this process is final and irreversible in given  environmental conditions. Hydrolytical decomposition of xanthates produces carbonate salts, carbon disulphide, trithiocarbonate salts and respective alcohol, which catalyses the reaction. The same decomposition products of hydrolysis were confirmed in the decomposition study of PIAX in simulated gastric fluids: a mixture of hydrochloric acid and sodium chloride (Institute Mol LLC, 2023). According to the available information, much of the information on xanthate toxicity is related to their highly toxic intermediate (decomposition) products, primarily carbon disulphide. For instance, carbon disulphide is less than 40% w/w equivalent for PIAX.   Considering repeated dose toxicity, there is no scientifically valid data on this type of toxicity on PIAX. However, historical studies are available for other xanthate salts (PIBX, SIAX,PIBX or PAX) and the decomposition products (carbon disulphide and 3-methylbutan-1-ol). This avialable stuides are used as a read-across sources for determination of repeated dose toxicity of PIAX.  The read-across justification is attached in Section 13. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1bbdd393-ac75-45d9-b9b5-9e7a8953e27e/documents/41be6c07-ae92-47d5-a59f-388ffcb69bde_507333db-a2fe-4f46-920d-79b270e1c40c.html,,,,,, Potassium isopentyl dithiocarbonate,928-70-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1bbdd393-ac75-45d9-b9b5-9e7a8953e27e/documents/41be6c07-ae92-47d5-a59f-388ffcb69bde_507333db-a2fe-4f46-920d-79b270e1c40c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Potassium isopentyl dithiocarbonate,928-70-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1bbdd393-ac75-45d9-b9b5-9e7a8953e27e/documents/41be6c07-ae92-47d5-a59f-388ffcb69bde_507333db-a2fe-4f46-920d-79b270e1c40c.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,23 mg/m3,,rat Potassium isopentyl dithiocarbonate,928-70-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1bbdd393-ac75-45d9-b9b5-9e7a8953e27e/documents/41be6c07-ae92-47d5-a59f-388ffcb69bde_507333db-a2fe-4f46-920d-79b270e1c40c.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.39 mg/cm2,no adverse effect observed,rabbit Potassium isopentyl dithiocarbonate,928-70-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1bbdd393-ac75-45d9-b9b5-9e7a8953e27e/documents/41be6c07-ae92-47d5-a59f-388ffcb69bde_507333db-a2fe-4f46-920d-79b270e1c40c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,23 mg/m3,no adverse effect observed,rabbit Potassium isopentyl dithiocarbonate,928-70-1,"Oral:There are two studies available for acute oral toxicity for the target substance. The oral LD50 (mouse) is 470 mg/kg bwThe oral LD50 (rat) is 765 mg/kg bwInhalation:No  study availableDermal:There is no valid data available for acute dermal toxicity for the target substance.The dermal LD50 (rat; male, female) for sodium ethyl xanthate, the analogue substance, is < 1 000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bbdd393-ac75-45d9-b9b5-9e7a8953e27e/documents/d6758cde-037a-4246-a20d-02f536bdc3ee_507333db-a2fe-4f46-920d-79b270e1c40c.html,,,,,, Potassium isopentyl dithiocarbonate,928-70-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bbdd393-ac75-45d9-b9b5-9e7a8953e27e/documents/d6758cde-037a-4246-a20d-02f536bdc3ee_507333db-a2fe-4f46-920d-79b270e1c40c.html,,oral,LD50,470 mg/kg bw,adverse effect observed, Potassium isopentyl dithiocarbonate,928-70-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bbdd393-ac75-45d9-b9b5-9e7a8953e27e/documents/d6758cde-037a-4246-a20d-02f536bdc3ee_507333db-a2fe-4f46-920d-79b270e1c40c.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, Potassium methanolate,865-33-8," Potassium methanolate is classified as corrosive to the skin according to Annex VI of the CLP regulation (EC 1272/2008). No systemic effects are expected at non-irritant concentrations / dose levels after repeated exposure to potassium methanolate via any route. It is unlikely that exposure to potassium methanolate at non-irritant concentrations / dose levels would result in exposure to toxic doses of the hydrolysis/dissociation products, particularly methanol. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7ac2600-f275-4cf1-8fcb-7fbf39b0177a/documents/dd28ad0f-9c6e-435f-87b5-6ec4f76cd578_fc14dd62-6c1d-464b-887e-2fdf017baaca.html,,,,,, Potassium methanolate,865-33-8,"Data waiving due to skin corrosive properties of the substance according to ANNEX VII-VIII, column 2 of the REACH regulation. according to ANNEX VII, column 2 of the REACH regulatio ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7ac2600-f275-4cf1-8fcb-7fbf39b0177a/documents/IUC5-d29f3adf-4dc9-4ede-9aa9-0ef41686de5b_fc14dd62-6c1d-464b-887e-2fdf017baaca.html,,,,,, "Potassium N,N-dimethylglycinate",17647-86-8,The no observed adverse effect level (NOAEL) for general systemic toxicity was 731 mg/kg bw/d for male and 960 mg/kg bw/d for female Wistar rats. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a727ceca-8cf8-48d5-842e-21abea376e19/documents/IUC5-42a94d81-11d1-4927-af94-5d718975adf0_992278f1-4b6d-43e7-b23d-418a83dbd8e3.html,,,,,, "Potassium N,N-dimethylglycinate",17647-86-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a727ceca-8cf8-48d5-842e-21abea376e19/documents/IUC5-42a94d81-11d1-4927-af94-5d718975adf0_992278f1-4b6d-43e7-b23d-418a83dbd8e3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,731 mg/kg bw/day,,rat "Potassium N,N-dimethylglycinate",17647-86-8,"LD50 (oral) > 2250 mg/kg bw (BASF AG, 1979)LD50 (dermal) > 2000 mg/kg bw (BASF SE, 2015) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a727ceca-8cf8-48d5-842e-21abea376e19/documents/IUC5-72a77a8e-2fea-4528-af74-49f6f564feca_992278f1-4b6d-43e7-b23d-418a83dbd8e3.html,,,,,, "Potassium N,N-dimethylglycinate",17647-86-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a727ceca-8cf8-48d5-842e-21abea376e19/documents/IUC5-72a77a8e-2fea-4528-af74-49f6f564feca_992278f1-4b6d-43e7-b23d-418a83dbd8e3.html,,oral,discriminating dose,"2,250 mg/kg bw",adverse effect observed, "Potassium N,N-dimethylglycinate",17647-86-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a727ceca-8cf8-48d5-842e-21abea376e19/documents/IUC5-72a77a8e-2fea-4528-af74-49f6f564feca_992278f1-4b6d-43e7-b23d-418a83dbd8e3.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Potassium neodecanoate,26761-42-2," No repeated dose toxicity study with potassium neodecanoate is available, thus the repeated dose toxicity will be addressed with existing data on the individual moieties potassium and neodecanoate. In relevant and reliable repeated dose toxicity studies as well as supporting studies for both constituents of potassium neodecanoate, there were no toxicological findings reported that would justify a classification for specific target organ toxicity with repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4f2beecb-13b3-44cd-b0a5-b83b09d8bd12/documents/88e7a930-4ea5-4d3d-9ee8-8091424274df_74168a2d-a2cf-4774-98f2-c87b353d6b2c.html,,,,,, Potassium neodecanoate,26761-42-2," No acute toxicity studies with potassium neodecanoate are available, thus the acute toxicity will be addressed with existing data on the individual moieties potassium and neodecanoate. Signs of acute oral or acute dermal toxicity are not expected for potassium neodecanoate, since the two moieties potassium and neodecanoic acid have not shown signs of acute oral or acute dermal toxicity in experimental testing (both LD50 > 2000mg/kg). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4f2beecb-13b3-44cd-b0a5-b83b09d8bd12/documents/0fde418b-e97d-4905-96b0-c4a28e14a0d9_74168a2d-a2cf-4774-98f2-c87b353d6b2c.html,,,,,, Potassium niobate,12030-85-2," Oral exposure: Potassium Niobate was fed to three groups of 5 weaned, male rats each at dietary levels of 0, 0.10 and 1 % for a duration of 7 weeks. No abnormal gross findings were noted in these rats. Kidney weights and kidney weight to body weight ratios were within control limits. Histopathological examination of sections of the liver, kidney, or spleen revealed no tissue changes that could be attributed to the ingestion of potassium niobate. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b792dc2f-cdf6-4f8b-8063-0877ebcbb1d7/documents/8c61cd1a-09f4-4d46-a515-dfef8db8ea1e_46ac0094-7b46-446b-89db-34fe27e0ce73.html,,,,,, Potassium niobate,12030-85-2, In an acute oral toxicity study in rats conducted according to OECD 423 no mortality occurred at the limit dose of 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b792dc2f-cdf6-4f8b-8063-0877ebcbb1d7/documents/c50fb162-6097-4e55-b076-30c6f549f51b_46ac0094-7b46-446b-89db-34fe27e0ce73.html,,,,,, Potassium O-ethyl dithiocarbonate,140-89-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb0aa554-fa89-459d-be89-8d395bcf26b1/documents/402ba5bb-6526-473b-aa4d-f132a1329845_a99f714b-e630-42e7-b70e-862321733da7.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,100 mg/m3,,dog Potassium O-ethyl dithiocarbonate,140-89-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb0aa554-fa89-459d-be89-8d395bcf26b1/documents/402ba5bb-6526-473b-aa4d-f132a1329845_a99f714b-e630-42e7-b70e-862321733da7.html,Chronic toxicity – systemic effects,oral,LOAEL,10 mg/kg bw/day,,rat Potassium O-ethyl dithiocarbonate,140-89-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb0aa554-fa89-459d-be89-8d395bcf26b1/documents/46fa53ef-f755-42e5-9935-a9eaf00ed5ea_a99f714b-e630-42e7-b70e-862321733da7.html,,oral,LD50,"1,700 mg/kg bw",adverse effect observed, Potassium O-ethyl dithiocarbonate,140-89-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb0aa554-fa89-459d-be89-8d395bcf26b1/documents/46fa53ef-f755-42e5-9935-a9eaf00ed5ea_a99f714b-e630-42e7-b70e-862321733da7.html,,inhalation,LC50,"7,690 mg/m3",adverse effect observed, Potassium O-isobutyl dithiocarbonate,13001-46-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ccc0d1e1-7e3d-4583-9901-16d717204e16/documents/09683289-8f3f-46ba-95cb-ee1550558a7d_e13ed7e9-e580-4737-8078-d3042eda44b2.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,100 mg/m3,,dog Potassium O-isobutyl dithiocarbonate,13001-46-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ccc0d1e1-7e3d-4583-9901-16d717204e16/documents/09683289-8f3f-46ba-95cb-ee1550558a7d_e13ed7e9-e580-4737-8078-d3042eda44b2.html,Chronic toxicity – systemic effects,oral,LOAEL,10 mg/kg bw/day,,rat Potassium O-isobutyl dithiocarbonate,13001-46-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccc0d1e1-7e3d-4583-9901-16d717204e16/documents/6300d906-8438-48b5-bb5f-65488b035afb_e13ed7e9-e580-4737-8078-d3042eda44b2.html,,oral,LD50,"ca.1,290 mg/kg bw",adverse effect observed, Potassium O-isobutyl dithiocarbonate,13001-46-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ccc0d1e1-7e3d-4583-9901-16d717204e16/documents/6300d906-8438-48b5-bb5f-65488b035afb_e13ed7e9-e580-4737-8078-d3042eda44b2.html,,inhalation,LC50,"7,690 mg/m3",adverse effect observed, Potassium O-pentyl dithiocarbonate,2720-73-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73fc2165-bb94-4c00-8310-5ccec5f50da7/documents/7ea1d3fd-1eab-46c9-aabb-faf7e8f8fac0_5b7d89a1-6aa7-4cf3-b400-79022043d6ae.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,100 mg/m3,,dog Potassium O-pentyl dithiocarbonate,2720-73-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73fc2165-bb94-4c00-8310-5ccec5f50da7/documents/7ea1d3fd-1eab-46c9-aabb-faf7e8f8fac0_5b7d89a1-6aa7-4cf3-b400-79022043d6ae.html,Chronic toxicity – systemic effects,oral,LOAEL,10 mg/kg bw/day,,rat Potassium O-pentyl dithiocarbonate,2720-73-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73fc2165-bb94-4c00-8310-5ccec5f50da7/documents/a5794b3e-8a5b-4468-940c-dc5f8774c6c1_5b7d89a1-6aa7-4cf3-b400-79022043d6ae.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, Potassium O-pentyl dithiocarbonate,2720-73-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73fc2165-bb94-4c00-8310-5ccec5f50da7/documents/a5794b3e-8a5b-4468-940c-dc5f8774c6c1_5b7d89a1-6aa7-4cf3-b400-79022043d6ae.html,,inhalation,LC50,"7,690 mg/m3",adverse effect observed, Potassium pentaborate,11128-29-3,"A number of oral sub-chronic and chronic studies on boric acid and disodium tetraborate decahydrate were carried out in rats, mice and dogs. In some cases, these studies are research studies (Weir and Fisher, 1972; Dixon et al, 1976; Seal and Weeth, 1980; Lee et al., 1978; Treinen and Chapin, 1991; Ku et al., 1993), but most support that boron can cause adverse haematological effects and that the main target organ of boron toxicity is the testis. The NOAEL for fertility effects is equivalent to 17.5 mg B/kg bw/day (Weir, 1966) that corresponds to a NOAEL of 71.7 mg potassium pentaborate/kg bw (anhydrous, and 95 mg potassium pentaborate tetrahydrate/kg bw).  Based on the sub-acute inhalation study on boron oxide conducted in rats (Wilding, 1960), the NOAEC for systemic effects is equivalent to 146 mg B/m3 that corresponds to a NOAEC of 598 mg potassium pentaborate/m3 (anhydrous, and 792 mg potassium pentaborate tetrahydrate/m3).   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study meets generally accepted scientific standards with acceptable restrictions. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ba8ac69-4fd4-45d2-8170-f778feedc25b/documents/cf0e31f7-5c5b-4e76-af0c-2d2ebac8d737_173cb425-23a6-4cf0-b751-3aea9a1991c5.html,,,,,, Potassium pentaborate,11128-29-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ba8ac69-4fd4-45d2-8170-f778feedc25b/documents/cf0e31f7-5c5b-4e76-af0c-2d2ebac8d737_173cb425-23a6-4cf0-b751-3aea9a1991c5.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,598 mg/m3,,rat Potassium pentaborate,11128-29-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1ba8ac69-4fd4-45d2-8170-f778feedc25b/documents/cf0e31f7-5c5b-4e76-af0c-2d2ebac8d737_173cb425-23a6-4cf0-b751-3aea9a1991c5.html,Chronic toxicity – systemic effects,oral,NOAEL,71.7 mg/kg bw/day,,rat Potassium pentaborate,11128-29-3,"Acute oral studies have been performed with potassium tetraborate, disodium tetraborate, sodium tetraborate pentahydrate, sodium tetraborate decahydrate and boric acid. Acute dermal and inhalation studies have been performed with disodium tetraborate pentahydrate, disodium tetraborate decahydrate and boric acid. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): High quality (there are a lot of reliable studies for different boron species available). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): High quality (there are reliable studies for different boron species available). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): High quality (there are reliable studies for different boron species available). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ba8ac69-4fd4-45d2-8170-f778feedc25b/documents/82913591-48ff-4e4a-8fd9-ecc7ecec7bf7_173cb425-23a6-4cf0-b751-3aea9a1991c5.html,,,,,, Potassium pentaborate,11128-29-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ba8ac69-4fd4-45d2-8170-f778feedc25b/documents/82913591-48ff-4e4a-8fd9-ecc7ecec7bf7_173cb425-23a6-4cf0-b751-3aea9a1991c5.html,,oral,LD50,"2,800 mg/kg bw",no adverse effect observed, Potassium pentaborate,11128-29-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ba8ac69-4fd4-45d2-8170-f778feedc25b/documents/82913591-48ff-4e4a-8fd9-ecc7ecec7bf7_173cb425-23a6-4cf0-b751-3aea9a1991c5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Potassium pentaborate,11128-29-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ba8ac69-4fd4-45d2-8170-f778feedc25b/documents/82913591-48ff-4e4a-8fd9-ecc7ecec7bf7_173cb425-23a6-4cf0-b751-3aea9a1991c5.html,,inhalation,LC50,"2,030 mg/m3",no adverse effect observed, Potassium perchlorate,7778-74-7, The oral route is the most likely route of (repeated) exposure. A NOAEL value is not determined by the study reliable enough to be used as starting point for the derivation of a DNEL. Thus the LOAEL value is used as a starting point. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee969a00-82b1-4430-8a75-ed83f456cd37/documents/3714175a-ef12-4a65-b81a-604724c633bb_52933ebd-ed51-49af-ba24-f79553651df6.html,,,,,, Potassium perchlorate,7778-74-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ee969a00-82b1-4430-8a75-ed83f456cd37/documents/3714175a-ef12-4a65-b81a-604724c633bb_52933ebd-ed51-49af-ba24-f79553651df6.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,11.8 mg/kg bw/day,,rat Potassium phosphinate,7782-87-8, There were no data for repeated dose toxicity for Potassium phosphinate however the potential toxicity of sodium hypophosphite following repeated administration was investigated according to OECD guideline 422 and EPA guideline OPPTS 870.3650. Sodium hypophosphite is of low toxicity by repeated administration: The NOAEL was established to 1080 mg/kg/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dfcb8fc5-e837-42d9-92f8-a03e54fe7baf/documents/56479459-ff43-46da-8940-1b5a808d8461_69a1f78a-00ab-4949-b9fe-129596ef8bba.html,,,,,, Potassium phosphinate,7782-87-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dfcb8fc5-e837-42d9-92f8-a03e54fe7baf/documents/56479459-ff43-46da-8940-1b5a808d8461_69a1f78a-00ab-4949-b9fe-129596ef8bba.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,080 mg/kg bw/day",,rat Potassium phosphinate,7782-87-8," There were no acute toxicity for Potassium phosphinate however acute toxicity studies were available for Sodium phosphinate also named Sodium hypophosphite and can be used for read across as follows: - an acute oral toxicity test in rats (method comparable to EPA 870.1100 and OECD 401 guidelines, GLP compliance not stated in the study report) - an acute dermal toxicity test in rabbits (method comparable to EPA 870.1200 and OECD 402 guidelines, GLP compliance not stated in the study report) Sodium hypophosphite is of low acute toxicity following oral exposure: The oral LD50 was found to be greater than 5000 mg/kg bw in male rats. The oral LD50 in female rats was found to be lower than 5000 mg/kg bw and should be included in the 2000-5000 mg/kg bw acute toxic class. Sodium hypophosphite is of low acute toxicity following dermal exposure: The dermal LD0 was determined to be equal or greater than 2000 mg/kg bw in rabbits. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfcb8fc5-e837-42d9-92f8-a03e54fe7baf/documents/d7668670-8cd1-4caa-9998-31583bdb69f8_69a1f78a-00ab-4949-b9fe-129596ef8bba.html,,,,,, Potassium phosphinate,7782-87-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfcb8fc5-e837-42d9-92f8-a03e54fe7baf/documents/d7668670-8cd1-4caa-9998-31583bdb69f8_69a1f78a-00ab-4949-b9fe-129596ef8bba.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Potassium phosphinate,7782-87-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dfcb8fc5-e837-42d9-92f8-a03e54fe7baf/documents/d7668670-8cd1-4caa-9998-31583bdb69f8_69a1f78a-00ab-4949-b9fe-129596ef8bba.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Potassium sodium 4,4'-bis[6-anilino-4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",70942-01-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9c528b7-02fd-456b-9615-606afdf021e8/documents/c39b5095-19af-496f-aaf8-87442481018a_5d31fd63-e0ea-48b0-bfa2-74936ed61876.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Potassium sodium 4,4'-bis[6-anilino-4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",70942-01-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9c528b7-02fd-456b-9615-606afdf021e8/documents/IUC5-1036abff-1b48-4577-a155-4fce4a530f6d_5d31fd63-e0ea-48b0-bfa2-74936ed61876.html,,oral,LD50,"2,200 mg/kg bw",no adverse effect observed, "Potassium sodium 4,4'-bis[6-anilino-4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",70942-01-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9c528b7-02fd-456b-9615-606afdf021e8/documents/IUC5-1036abff-1b48-4577-a155-4fce4a530f6d_5d31fd63-e0ea-48b0-bfa2-74936ed61876.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Potassium sodium 4,4'-bis[6-anilino-4-[bis(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",70942-01-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9c528b7-02fd-456b-9615-606afdf021e8/documents/IUC5-1036abff-1b48-4577-a155-4fce4a530f6d_5d31fd63-e0ea-48b0-bfa2-74936ed61876.html,,inhalation,LC50,"1,895 mg/m3",no adverse effect observed, Potassium sulphanilate,29901-62-0,Neither for the test substance nor for sulfanilic acid are any data available. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/428bc792-0109-4582-bc33-9828e80c896a/documents/IUC5-549ff88d-c965-4645-b2e2-fd337253ab38_ee011b03-5442-453d-831e-0ccea4b02871.html,,,,,, Potassium sulphanilate,29901-62-0,"No experimental data is available. The substance is a metabolite from verious food dyes that are non-toxic in experimental animals. The acute oral toxicity of the sodium salt analogue was tested in rat, the LD50 was considered to be > 5000 mg/kg bw. Also, acute oral toxicity of sulfanilic acid was tested in rats. The LD50 of the free acid was found to be higher than 2000 mg/kg bw. However, no data about dermal or inhalative toxicity are available.Therefore, the test substance is considered to be not toxic after single oral application. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/428bc792-0109-4582-bc33-9828e80c896a/documents/IUC5-6e8983fe-921b-45e2-b6d6-de498c0a73cf_ee011b03-5442-453d-831e-0ccea4b02871.html,,,,,, Potassium sulphanilate,29901-62-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/428bc792-0109-4582-bc33-9828e80c896a/documents/IUC5-6e8983fe-921b-45e2-b6d6-de498c0a73cf_ee011b03-5442-453d-831e-0ccea4b02871.html,,oral,LD50,"2,000 mg/kg bw",, Potassium superoxide,12030-88-5," In vivo, potassium superoxide reacts rapidly with water to produce potassium hydroxide (KOH), oxygen (O2) and potassium hydrogen peroxide (KHO2), which slowly degrades to KOH, H2O2 (hydrogen peroxide) and O2. KOH further dissociates into potassium and hydroxyl ions which constitute normal physiological ion pool. On the other hand, hydrogen peroxide is likely to degrade within a short time in in vivo conditions due to many alternative and competitive degradation pathways. Especially, in alkaline medium and in the presence of heavy and transition metals it is degraded rapidly. As a result, the contribution of toxicity from hydrogen peroxide is likely to be low. Overall, toxicity of potassium superoxide is likely to be low and a quantitative estimation of the hazard potential will not be appropriate due to its rapidly changing degradation kinetics. No significant exposure occurs at the level of industrial/professional handling: KO2 is not manufactured in the EU. The substance is imported in the form of low dust tablets which are sealed and packed. Upon opening and before use, dust reduction measures are taken to avoid exposure via inhalation. The tablets are transferred from the barrels/bags into cartridges that are integrated into sealed Oxygen Self Rescuer units. No significant exposure occurs at the level of consumer use: The self-rescuer device serves as a rescue device in emergency situations e.g. in mines or aircrafts. The user puts on the device and breathes through a mouthpiece and breathing tube. The moisture and CO2 from the breath react with KO2 to generate oxygen, potassium hydroxide and potassium carbonate in the cartridge. Due to the specific design of the device, the user is protected from any contact with KO2 or inhaling KO2 dust. When spent, the cartridges are sent back for recycling or waste incineration. Unused devices are disposed of in a similar way. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6499e198-bfe6-4bbc-a71d-458568e8bccc/documents/f54a9dfd-cc79-45ee-95c7-8c035caeb12e_cd8b61d2-d2d6-4a6d-a1d4-862ac82ab636.html,,,,,, Potassium superoxide,12030-88-5, Assessment of acute toxicity or its classification is not warranted as the substance is classified as skin corrosive 1A according to the EU CLP (1272/2008) criteria. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6499e198-bfe6-4bbc-a71d-458568e8bccc/documents/01f0c3b9-2c71-47d9-b5ee-5da14aa6e509_cd8b61d2-d2d6-4a6d-a1d4-862ac82ab636.html,,,,,, Potassium tetrafluoroaluminate,14484-69-6,"Based on read-across from multiconstituent aluminium potassium fluoride, the most critical effects of potassium tetrafluoroaluminate after repeated inhalation exposure are expected to be effects on the lungs. Based on the available studies, the overall NOAEC for local effects (corrected for molecular weight) is 1.07 mg/m3. The overall systemic NOAEC (corrected for molecular weight) is 2.73 mg/m3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d928e40-522c-4159-ab7d-e40e696daa50/documents/IUC5-92780154-4ae3-439c-acf1-b34dd7b87413_9ff52257-6523-4d85-ae98-00d2f07f8928.html,,,,,, Potassium tetrafluoroaluminate,14484-69-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d928e40-522c-4159-ab7d-e40e696daa50/documents/IUC5-92780154-4ae3-439c-acf1-b34dd7b87413_9ff52257-6523-4d85-ae98-00d2f07f8928.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,1.07 mg/m3,,rat Potassium tetrafluoroaluminate,14484-69-6,"Based on read-across from multiconstituent aluminium potassium fluoride, the oral LD50 is 2.41 (2.24-2.60) g/kg bw for male and 1.91 (1.43-2.56) g/kg bw for female rats for potassium tetrafluoroaluminate, with an average LD50 of 2.16 (1.84-2.58) g/kg for both sexes.The rat inhalation LC50 for 1 hour is >3.88 mg/L, based on the read-across from multiconstituent aluminium potassium fluoride.The dermal LD50 value is >2.0 g/kg bw in rabbits based on the read-across from multiconstituent aluminium potassium fluoride. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d928e40-522c-4159-ab7d-e40e696daa50/documents/IUC5-625f3355-c57e-422a-8164-cf989d5d3e47_9ff52257-6523-4d85-ae98-00d2f07f8928.html,,,,,, Potassium tetrafluoroborate,14075-53-7,A NOAEL of 40 mg/kg bw/day was established in a reproduction/developmental toxicity screening test and a NOAEL of 226 mg/m3 was established in a 90-day inhalation study in rats for systemic effects. No local effect were observed at concentrations up to 226 mg/m3 in the 90-day inhalation study. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e15e499f-7059-4956-972b-2adcf0f81efa/documents/IUC5-da08a564-e240-4264-8e7e-277c1aa362d8_6fa3920e-c08e-47ea-abe9-df0d4b48950f.html,,,,,, Potassium tetrafluoroborate,14075-53-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e15e499f-7059-4956-972b-2adcf0f81efa/documents/IUC5-da08a564-e240-4264-8e7e-277c1aa362d8_6fa3920e-c08e-47ea-abe9-df0d4b48950f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat Potassium tetrafluoroborate,14075-53-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e15e499f-7059-4956-972b-2adcf0f81efa/documents/IUC5-da08a564-e240-4264-8e7e-277c1aa362d8_6fa3920e-c08e-47ea-abe9-df0d4b48950f.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,226 mg/m3,,rat Potassium tetrafluoroborate,14075-53-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e15e499f-7059-4956-972b-2adcf0f81efa/documents/IUC5-da08a564-e240-4264-8e7e-277c1aa362d8_6fa3920e-c08e-47ea-abe9-df0d4b48950f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,226 mg/m3,no adverse effect observed,rat Potassium tetrafluoroborate,14075-53-7,A LD50 greater than 2000 mg NaBF4/kg bw (equivalent to 2294 mg KBF4) was observed in the acute oral toxicity study and a LD50 of 5300 mg KBF4/m3 bw was observed in the inhalation toxicity study. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e15e499f-7059-4956-972b-2adcf0f81efa/documents/IUC5-e83cdf94-edd4-49f2-a2e4-687bf04f77aa_6fa3920e-c08e-47ea-abe9-df0d4b48950f.html,,,,,, Potassium tetrafluoroborate,14075-53-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e15e499f-7059-4956-972b-2adcf0f81efa/documents/IUC5-e83cdf94-edd4-49f2-a2e4-687bf04f77aa_6fa3920e-c08e-47ea-abe9-df0d4b48950f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Potassium tetrafluoroborate,14075-53-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e15e499f-7059-4956-972b-2adcf0f81efa/documents/IUC5-e83cdf94-edd4-49f2-a2e4-687bf04f77aa_6fa3920e-c08e-47ea-abe9-df0d4b48950f.html,,inhalation,LC50,"5,300 mg/m3",no adverse effect observed, Potassium tetrahydroborate,13762-51-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42781ea5-542f-4db7-9828-1714091c4a40/documents/bb766daf-3355-4946-9c06-800039ff126f_0d6f1842-3853-4404-a6a4-3c3fffce9c4a.html,,oral,LD50,145 mg/kg bw,adverse effect observed, Potassium thiosulphate,10294-66-3,"A 3-generation chronic toxicity study (Til et al. 1972a) with treatment of rats (20 per sex and group) with dose levels of 0, 0.125, 0.25, 0.5, 1.0 or 2.0% Na2S2O5 administered in a 50 ppm thiamine-containing diet was identified as most reliable study for repeated dose toxicity and was defined as key study (for read-across info, see `discussion`). Based on the read across concept for the group of sulfite and thiosulfate substances, this result is also applicable to potassium thiosulfate. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/326eb04d-be39-4b45-9975-32beceebb6fc/documents/IUC5-108e8ddf-15d3-4fb1-ac8d-c1bd6f30d0a8_10fbf62f-588d-45dd-8a5d-6d476f42fd63.html,,,,,, Potassium thiosulphate,10294-66-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/326eb04d-be39-4b45-9975-32beceebb6fc/documents/IUC5-108e8ddf-15d3-4fb1-ac8d-c1bd6f30d0a8_10fbf62f-588d-45dd-8a5d-6d476f42fd63.html,Chronic toxicity – systemic effects,oral,NOAEL,216 mg/kg bw/day,,rat Potassium thiosulphate,10294-66-3,"Acute toxicity values (oral, dermal and inhalative) were determined for potassium thiosulfate utilising substance specific data as well as data from read-across to sodium sulfite (CAS 7757-83-7) and calcium thiosulfate (CAS 10124-41-1). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/326eb04d-be39-4b45-9975-32beceebb6fc/documents/IUC5-47770ad3-c77d-46da-9470-f60385ee67d7_10fbf62f-588d-45dd-8a5d-6d476f42fd63.html,,,,,, Terracess TF,690271-93-3,In a 90 day repeated dose inhalation toxicity study ( OECD 413/OPPTS 870.3465) with rats no adverse effects were observed at 10mg/m3. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c4acfe0-c1c7-4216-9399-14b8834c530f/documents/IUC5-38546fd1-13cd-41c3-9b55-23059d15c41f_df0d8c9b-32e2-4d28-a17c-6ad114bc41cc.html,,,,,, Terracess TF,690271-93-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c4acfe0-c1c7-4216-9399-14b8834c530f/documents/IUC5-38546fd1-13cd-41c3-9b55-23059d15c41f_df0d8c9b-32e2-4d28-a17c-6ad114bc41cc.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,10 mg/m3,,rat Terracess TF,690271-93-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c4acfe0-c1c7-4216-9399-14b8834c530f/documents/IUC5-38546fd1-13cd-41c3-9b55-23059d15c41f_df0d8c9b-32e2-4d28-a17c-6ad114bc41cc.html,Repeated dose toxicity – local effects,inhalation,NOAEC,10 mg/m3,adverse effect observed,rat Terracess TF,690271-93-3,"Acute oral toxicity test with female rats (OECD 425, OPPTS 870:1100): LD50 > 2000 mg/kg bwAcute dermal toxicity test with male and female rats (EC B.3, OECD 402, OPPTS 870:1200): LD50> 5000 mg/kg bwAcute inhalation test with male and female rats (EC B.2, OECD 403, OPPTS 870.1300): LC50 > 5.2 mg/L air ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c4acfe0-c1c7-4216-9399-14b8834c530f/documents/IUC5-be96c565-3e85-4860-9e8c-2640cf808025_df0d8c9b-32e2-4d28-a17c-6ad114bc41cc.html,,,,,, Terracess TF,690271-93-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c4acfe0-c1c7-4216-9399-14b8834c530f/documents/IUC5-be96c565-3e85-4860-9e8c-2640cf808025_df0d8c9b-32e2-4d28-a17c-6ad114bc41cc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Terracess TF,690271-93-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c4acfe0-c1c7-4216-9399-14b8834c530f/documents/IUC5-be96c565-3e85-4860-9e8c-2640cf808025_df0d8c9b-32e2-4d28-a17c-6ad114bc41cc.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Terracess TF,690271-93-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c4acfe0-c1c7-4216-9399-14b8834c530f/documents/IUC5-be96c565-3e85-4860-9e8c-2640cf808025_df0d8c9b-32e2-4d28-a17c-6ad114bc41cc.html,,inhalation,LC50,5.3 mg/m3,no adverse effect observed, Potassium trifluoroacetate,2923-16-2,"Oral exposure to the reaction mass of TFSK/TFAK (OECD 422, GLP) did not result in any treatment related findings and the No Observed Adverse Effect Level (NOAEL) for oral subacute toxicity was considered to be 1000 mg/kg/day of active ingredient. Oral exposure to the reaction mass of TFSK/TFAK (OECD 408, GLP) resulted in increased relative and absolute liver weights in male and female animals and treatment-related changes in blood biochemistry parameters (ALP and T-Bil). The NOAEL for subchronic toxicity was considered to be 100 and 300 mg/kg/day of active ingredient for males and females, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c752bfab-9853-4b86-9e3c-d5b34bfa5e98/documents/IUC5-21464e4f-fd20-478c-a33b-16d7f0b6e289_29b84491-89d1-40f5-8d67-0fbe1ca1f348.html,,,,,, Potassium trifluoroacetate,2923-16-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c752bfab-9853-4b86-9e3c-d5b34bfa5e98/documents/IUC5-21464e4f-fd20-478c-a33b-16d7f0b6e289_29b84491-89d1-40f5-8d67-0fbe1ca1f348.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Potassium trifluoroacetate,2923-16-2,LD50 oral > 2000 mg/kgLD50 dermal > 1000 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c752bfab-9853-4b86-9e3c-d5b34bfa5e98/documents/IUC5-704dd647-ae45-4f16-bb64-bc9daa4ff2d1_29b84491-89d1-40f5-8d67-0fbe1ca1f348.html,,,,,, Potassium trifluorozincate,13827-02-6,"Inhalation exposure to potassium trifluorozincate (OECD 413, GLP) resulted in treatment-related changes in the nose and lungs, consisting of olfactory epithelial degeneration (nose) and multifocal accumulation of alveolar macrophages accompanied by increased weight of the lungs. Since the changes in the nose were also observed – although at a lower incidence – at the low concentration level of 1.09 mg/m3, this concentration is considered to be the Lowest-Observed-Adverse-Effect-Level (LOAEL) in rats after sub-chronic (90-day) exposure by inhalation to Nocolok Zn Flux. A two-month recovery period after the last exposure resulted in complete (for changes in the nose) or almost complete (for changes in the lungs) recovery.Oral exposure to potassium trifluorozincate (OECD 422, GLP) resulted in treatment-related changes in the stomach at all dose levels (local NOAEL <7.5 mg/kg bw) and in mortality and decreased plasma levels of total protein and albumin in the mid- and high-dose group (systemic NOAEL 7.5 mg/kg bw). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70794fa8-387b-4555-a446-41191e4099c0/documents/IUC5-ea43e39f-4a42-457c-93ad-a278aced4264_31bc008e-6179-4e97-b383-cd6343b24ba0.html,,,,,, Potassium trifluorozincate,13827-02-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70794fa8-387b-4555-a446-41191e4099c0/documents/IUC5-ea43e39f-4a42-457c-93ad-a278aced4264_31bc008e-6179-4e97-b383-cd6343b24ba0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,7.5 mg/kg bw/day,,rat Potassium trifluorozincate,13827-02-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70794fa8-387b-4555-a446-41191e4099c0/documents/IUC5-ea43e39f-4a42-457c-93ad-a278aced4264_31bc008e-6179-4e97-b383-cd6343b24ba0.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,10.48 mg/m3,,rat Potassium trifluorozincate,13827-02-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70794fa8-387b-4555-a446-41191e4099c0/documents/IUC5-ea43e39f-4a42-457c-93ad-a278aced4264_31bc008e-6179-4e97-b383-cd6343b24ba0.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1.09 mg/m3,adverse effect observed,rat Potassium trifluorozincate,13827-02-6,"A LD50 range between 200-2000 mg KZnF3/kg bw was observed in the acute oral toxicity study, a LC50 greater than 75 mg KZnF3/m3 was observed in the inhalation toxicity study, and a LD50 >2000 mg KZnF3/kg bw was observed in the acute dermal toxicity study. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70794fa8-387b-4555-a446-41191e4099c0/documents/IUC5-53a97cbb-4889-4135-a395-90678e8a550f_31bc008e-6179-4e97-b383-cd6343b24ba0.html,,,,,, Potassium trifluorozincate,13827-02-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70794fa8-387b-4555-a446-41191e4099c0/documents/IUC5-53a97cbb-4889-4135-a395-90678e8a550f_31bc008e-6179-4e97-b383-cd6343b24ba0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Potassium trifluorozincate,13827-02-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70794fa8-387b-4555-a446-41191e4099c0/documents/IUC5-53a97cbb-4889-4135-a395-90678e8a550f_31bc008e-6179-4e97-b383-cd6343b24ba0.html,,inhalation,LC50,75 mg/m3,adverse effect observed, Potassium trihydrogen dioxalate,127-96-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/01d2eb31-194c-4445-8c96-4449029aa18b/documents/IUC5-d4dc64f6-f91b-424b-bc30-f80753604ca6_5bd6e267-8fd0-4392-9353-b2f89d4ac92d.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,150 mg/kg bw/day,,rat Potassium trihydrogen dioxalate,127-96-8,Acute toxicity:Oral: LD50: 375 mg/kg bwDermal: 20000 mg/kg bwInhalation: no data ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01d2eb31-194c-4445-8c96-4449029aa18b/documents/IUC5-a74b3eeb-03b2-4ec0-ae9c-b70983232048_5bd6e267-8fd0-4392-9353-b2f89d4ac92d.html,,,,,, Potassium trihydrogen dioxalate,127-96-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01d2eb31-194c-4445-8c96-4449029aa18b/documents/IUC5-a74b3eeb-03b2-4ec0-ae9c-b70983232048_5bd6e267-8fd0-4392-9353-b2f89d4ac92d.html,,oral,LD50,375 mg/kg bw,, Potassium trihydrogen dioxalate,127-96-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/01d2eb31-194c-4445-8c96-4449029aa18b/documents/IUC5-a74b3eeb-03b2-4ec0-ae9c-b70983232048_5bd6e267-8fd0-4392-9353-b2f89d4ac92d.html,,dermal,LD50,"20,000 mg/kg bw",, Potassium vanadium trioxide,13769-43-2,"Description of key information - soluble vanadium substances group (oral) A comprehensive literature search was recently conducted for the vanadium category substances, to source relevant information for the hazard and risk assessment. For the group of the soluble vanadium substances, a limited number of studies is available, and the different experimental approaches lead to a variety of endpoints measured. Of the limited effects noted following oral exposure with soluble vanadium substances, it appears most likely that effects on haematological parameters are the most consistently reported among a number of investigators (Mountain et al 1953, Zaporowska et al. 1993, Scibior et al 2006, Scibior, 2005, NTP, 2002, NTP, 2023). Altogether, haematological effects have been found with a variety of different vanadium compounds including sodium metavanadate, vanadium pentoxide, and ammonium metavanadate supporting the use of this endpoint for risk assessment purposes. Furthermore, epithelial hyperplasia in the small intestine of rats and mice were observed after the administration of sodium metavanadate and vanadyl sulfate (NTP, 2023). Therefore, this endpoint should also be considered for risk assessment purposes. Information on repeated dose toxicity following inhalation exposure to divanadium pentaoxide is available in a NTP study (k_NTP 2002) with exposure of male and female rats and mice to V2O5 over 16-days, 3-months and 2-years. Pulmonary reactivity to divanadium pentaoxide was also investigated following subchronic inhalation exposure in a non-human primate animal model. Data of the repeated-dose toxicity via the dermal route are not available for any vanadium substance. Following the HERAG guidance for metals and metal salts (see section 7.1.2 of the technical dossier: dermal absorption), negligible percutaneous uptake based on minimal penetration, i.e. a dermal absorption rate in the range of maximally 0.1 - 1.0 %, can be anticipated. Dermal absorption in this order of magnitude is not considered to be “significant”. Thus, regarding repeated-dose toxicity of vanadium substances, the dermal exposure route is not expected to be the most relevant. EBRC (2007) HERAG fact sheet - Assessment of occupational dermal exposure and dermal absorption for metals and inorganic metal compounds, EBRC Consulting GmbH, Hannover, Germany, August 2007, 49 pages.   Further information: Divanadium pentaoxide has been excluded from the soluble vanadium substances read-across group due to its legal classification. Thus, studies conducted with divanadium pentaoxide are reported for information purposes only. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c89686db-f60a-484f-8d5b-ff98948b1c67/documents/IUC5-bde0b010-258d-4f69-b9ef-97b309779de5_b3a1d796-5558-42b3-b9c9-b015f0974411.html,,,,,, Potassium vanadium trioxide,13769-43-2," Acute oral toxicity: LD50 = 314 mg/kg bw (OECD 401; GLP; female rats) Acute inhalation toxicity: LC50 1.85 mg/L air (analytical) (OECD 403; GLP, male rats) Acute dermal toxicity: LD50 > 2500 mg/kg bw (OECD 402; GLP) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c89686db-f60a-484f-8d5b-ff98948b1c67/documents/IUC5-ab529355-f0ba-4a93-9d9e-f0ff96067a25_b3a1d796-5558-42b3-b9c9-b015f0974411.html,,,,,, Potassium vanadium trioxide,13769-43-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c89686db-f60a-484f-8d5b-ff98948b1c67/documents/IUC5-ab529355-f0ba-4a93-9d9e-f0ff96067a25_b3a1d796-5558-42b3-b9c9-b015f0974411.html,,oral,LD50,314 mg/kg bw,adverse effect observed, Potassium vanadium trioxide,13769-43-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c89686db-f60a-484f-8d5b-ff98948b1c67/documents/IUC5-ab529355-f0ba-4a93-9d9e-f0ff96067a25_b3a1d796-5558-42b3-b9c9-b015f0974411.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, Potassium vanadium trioxide,13769-43-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c89686db-f60a-484f-8d5b-ff98948b1c67/documents/IUC5-ab529355-f0ba-4a93-9d9e-f0ff96067a25_b3a1d796-5558-42b3-b9c9-b015f0974411.html,,inhalation,LC50,"1,850 mg/m3",adverse effect observed, Potassium; 2-[bis[2-[bis(carboxylatomethyl)amino]ethyl]amino]acetate; iron(3+),2055396-18-2," In an extended oral OECD 422 study male animals were exposed for at least 13 weeks and females for almost 14 weeks. At the high dose level the following effects were observed: soft faeces (both sexes), decreased body weight gain (males), prolonged prothrombin time (males), increased haemoglobin concentration (males), decreased ALAT activity and chloride concentration (males) and decreased ALP activity and increased relative weights of kidneys and liver (both sexes). No toxicologically relevant changes were observed at the lower levels of 500 and 150 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73c3e745-076d-4eb7-b218-fa0978c3e89a/documents/e3f3b01e-c9db-4b3f-8779-d7673a8163c2_898e2e98-2c94-4909-929d-7841df1a6a1f.html,,,,,, Potassium; 2-[bis[2-[bis(carboxylatomethyl)amino]ethyl]amino]acetate; iron(3+),2055396-18-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73c3e745-076d-4eb7-b218-fa0978c3e89a/documents/e3f3b01e-c9db-4b3f-8779-d7673a8163c2_898e2e98-2c94-4909-929d-7841df1a6a1f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Potassium; 2-[bis[2-[bis(carboxylatomethyl)amino]ethyl]amino]acetate; iron(3+),2055396-18-2," The oral LD50 value is in excess of 2000 mg/kg bw; No acute dermal toxicity studies are available but based on read across (see also section 13), acute dermal toxicity following exposure to DTPA-FeK is not expected. In accordance with Annex VIII, testing by the inhalation route is not appropriate since exposure of humans via inhalation is unlikely to occur due to the low vapour pressure of the substance (1.82E-5 Pa at 20 °C). There is no possibility of exposure to the substance in form of aerosols, particles or droplets of an inhalable size, since the substance is manufactured in a controlled, hermetic process. The final product is microgranulate substance containing particles with aerodynamic diameter above 100 µm(no pollination). Furthermore, oral studies are available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73c3e745-076d-4eb7-b218-fa0978c3e89a/documents/f1dfb468-bd77-4487-a8a5-fed358d7d068_898e2e98-2c94-4909-929d-7841df1a6a1f.html,,,,,, p-phenylbenzaldehyde,3218-36-8,"Acute Oral Toxicity: The acute oral LD50 value (rat) was determined to be 1000 - 2000mg/kg for males and 1510 (1130-2040, p=0.05) mg/kg for females. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Study report summary, no GLP and guideline mentioned. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4becdb7e-744d-4761-bcda-fed946bc79f6/documents/IUC5-c81e136e-bde5-4c43-94c4-11ea9c4eeba0_fce92141-e7d2-493c-8a6c-7f18d08e55c6.html,,,,,, p-phenylbenzaldehyde,3218-36-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4becdb7e-744d-4761-bcda-fed946bc79f6/documents/IUC5-c81e136e-bde5-4c43-94c4-11ea9c4eeba0_fce92141-e7d2-493c-8a6c-7f18d08e55c6.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, p-phenylene diisocyanate,104-49-4," The read across for PPDI; is based upon the analogous substances to which basic form, degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of repeated dose toxicity. The animals were whole body exposed to 0, 0.05 and 0.15 ppm of TDI (80/20) vapour for 6 hours/day, 5 days/week. In both species, body weight gain was reduced at 0.15 ppm over the first 12 weeks that persisted but did not worsen over the remaining period of the study. In rats, rhinitis was observed in males at 0.15 ppm and in females beginning at 0.05 ppm, generally characterized by squamous metaplasia/hyperplasia of the respiratory mucosa, with and without exudate in the lumen, and leucocyte infiltration in the lamina propria. This finding is considered to be due to local irritation of the anterior nasal cavity. In mice, histopathology revealed marked inflammatory processes in trachea, larynx, bronchi, lungs and predominantly in nasal turbinates (chronic and necrotic rhinitis) of male and female animals beginning at 0.05 ppm. Therefore, the LOAEC for rats and mice is 0.05 ppm (0.362 mg/m3) after long-term inhalation of TDI vapour. Inhalation exposure is the most appropriate route for assessing occupational risk in humans. Effects from repeated exposure of animals to TDI are limited to effects on the respiratory tract caused by local irritation, no signs of systemic toxicity were observed. Simultaneously, other studies show that nose is the targeted organ of the respiratory system. Thus, the assessment confirmed the legal classification of the substance as STOT Single Exp.3 (Hazard statement H335, May cause respiratory irritation). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73ed2e03-e3ba-4ff9-b00e-64adcbf7f5da/documents/4dd242bd-617b-4ef6-ab8e-fb0aefe5e782_68705f14-2640-4033-95ea-419b423dcff7.html,,,,,, p-phenylene diisocyanate,104-49-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73ed2e03-e3ba-4ff9-b00e-64adcbf7f5da/documents/4dd242bd-617b-4ef6-ab8e-fb0aefe5e782_68705f14-2640-4033-95ea-419b423dcff7.html,Chronic toxicity – systemic effects,inhalation,LOAEC,0.362 mg/m3,,rat p-phenylene diisocyanate,104-49-4," The Oral LD50 value of is 5000 mg/kg body weight. The dermal LD50 value of PPDI was established to exceed 2000 mg/kg body weight. LC50 could not be established due to the large, non-respirable particulate formed at high concentrations ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73ed2e03-e3ba-4ff9-b00e-64adcbf7f5da/documents/cbf07fce-180e-428f-8914-ccbba32c3425_68705f14-2640-4033-95ea-419b423dcff7.html,,,,,, p-phenylene diisocyanate,104-49-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73ed2e03-e3ba-4ff9-b00e-64adcbf7f5da/documents/cbf07fce-180e-428f-8914-ccbba32c3425_68705f14-2640-4033-95ea-419b423dcff7.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, p-phenylene diisocyanate,104-49-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73ed2e03-e3ba-4ff9-b00e-64adcbf7f5da/documents/cbf07fce-180e-428f-8914-ccbba32c3425_68705f14-2640-4033-95ea-419b423dcff7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, p-phenylene diisocyanate,104-49-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73ed2e03-e3ba-4ff9-b00e-64adcbf7f5da/documents/cbf07fce-180e-428f-8914-ccbba32c3425_68705f14-2640-4033-95ea-419b423dcff7.html,,inhalation,LC50,335 mg/m3,no adverse effect observed, p-phenylenebis(methylamine),539-48-0, Oral: The LD50 of this substance was estimated to range between 500 and 2000 mg/kg bw in both male and female rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a86ec107-14f1-4c38-b032-1c125abc4f1d/documents/308cd378-5745-4f22-8959-f48f978beaca_0d0a669f-5cf1-4839-8af2-58e979735849.html,,,,,, p-phenylenebis(methylamine),539-48-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a86ec107-14f1-4c38-b032-1c125abc4f1d/documents/308cd378-5745-4f22-8959-f48f978beaca_0d0a669f-5cf1-4839-8af2-58e979735849.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Praseodymium trinitrate,10361-80-5,"Acute toxicity - oral:A K2 acute oral toxicity test was performed in female Sprague-Dawley rats according to a guideline similar to OECD Guideline 401 (Bruce DW, 1963). This study was selected as key study. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cda07f5b-6c8b-4471-8bbb-6f574d2489ae/documents/IUC5-7c92554f-898e-4075-a32b-95fd0b8e7c28_98bd07d7-0e9e-40fa-8361-f87d94d7f59a.html,,,,,, Praseodymium trinitrate,10361-80-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cda07f5b-6c8b-4471-8bbb-6f574d2489ae/documents/IUC5-7c92554f-898e-4075-a32b-95fd0b8e7c28_98bd07d7-0e9e-40fa-8361-f87d94d7f59a.html,,oral,LD50,"3,500 mg/kg bw",no adverse effect observed, "Praseodymium(III,IV) oxide",12037-29-5, An OECD 422 screening reproductive / developmental toxicity study has been conducted according to OECD test guideline number 422 using the oral exposure route. Under the conditions of this study the No Observed Adverse Effect Level (NOAEL) in Sprague-Dawley rats (male/female) was considered to be 1000 mg/kg/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fae9762-9cba-4427-bff8-8e79b6a18579/documents/IUC5-679f6e53-154d-4093-903b-eb44bbee433d_e01bd601-2d07-47bd-a06d-e40266ab63db.html,,,,,, "Praseodymium(III,IV) oxide",12037-29-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2fae9762-9cba-4427-bff8-8e79b6a18579/documents/IUC5-679f6e53-154d-4093-903b-eb44bbee433d_e01bd601-2d07-47bd-a06d-e40266ab63db.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Praseodymium(III,IV) oxide",12037-29-5,ACUTE TOXICITY: VIA THE ORAL ROUTEThe key study reports an acute oral LD50 in the rat of >2000 mg/kg bodyweight. The supporting study reports an acute oral LD50 in the rat of >5000 mg/kg bodyweight. ACUTE TOXICITY: VIA INHALATION ROUTEThe 4 hour LC50 in the rat was >5.21 mg/L. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2fae9762-9cba-4427-bff8-8e79b6a18579/documents/IUC5-489c3613-f9ac-4f69-88b0-6e403fef1079_e01bd601-2d07-47bd-a06d-e40266ab63db.html,,,,,, "21-Acetoxy-16 alpha-methyl-4-pregnene-3,20-dione",39987-85-4,"M-DOCA is harmful after single oral exposure (LD50 cut-off, rat: > 300 - < 500 mg/kg bw). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b19e144-340e-4222-97dc-90db3b339fd5/documents/IUC5-5357782b-bf48-4576-8ed5-243782e0c866_92c8d828-1d9a-4294-96b3-43209ca782fd.html,,,,,, "21-Acetoxy-6alpha-fluoro-11ß-hydroxy-16alpha-methyl-4-pregnene-3,20-dione",1176-81-4," In analogy to fluocortolone, the structurally analogue substance fluocortolone-A-acetate is considered to cause organ damage after repeated administration to test animals. In systemic tolerance studies with fluocortolone involving repeated administration of both subcutaneous and oral doses in rats and dogs for 4 to 80 weeks, typical glucocorticoid effects were observed: degeneration of lymphatic tissue, suppression of the adrenal cortex, impairment of the hematogenic tissue (bone marrow) (Dres et al., 1975; Günzel et al., 1976; Staben, 1979; Woodard et al., 1966, 1967, 1969). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45fc4a30-7d0b-4d5e-a9f2-8dd9b107f7b8/documents/8eb7eb15-ead3-46df-8ad0-48ec9cc3ba6e_d2db0431-619e-49fc-b24d-fccb4914b0a3.html,,,,,, "21-Acetoxy-6alpha-fluoro-11ß-hydroxy-16alpha-methyl-4-pregnene-3,20-dione",1176-81-4,"The acute toxicity (LD50) of fluocortolone-A-acetate in rats is > 2000 mg/kg bw after oral administration (Stark and Amir, 1998) and after dermal application (Stark and Wick, 1998).     ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45fc4a30-7d0b-4d5e-a9f2-8dd9b107f7b8/documents/d2130f93-875f-4aa1-b5c8-d97cac557f59_d2db0431-619e-49fc-b24d-fccb4914b0a3.html,,,,,, "21-Acetoxy-6alpha-fluoro-11ß-hydroxy-16alpha-methyl-4-pregnene-3,20-dione",1176-81-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45fc4a30-7d0b-4d5e-a9f2-8dd9b107f7b8/documents/d2130f93-875f-4aa1-b5c8-d97cac557f59_d2db0431-619e-49fc-b24d-fccb4914b0a3.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "21-Acetoxy-6alpha-fluoro-11ß-hydroxy-16alpha-methyl-4-pregnene-3,20-dione",1176-81-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45fc4a30-7d0b-4d5e-a9f2-8dd9b107f7b8/documents/d2130f93-875f-4aa1-b5c8-d97cac557f59_d2db0431-619e-49fc-b24d-fccb4914b0a3.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "21-Acetoxy-6 alpha-fluoro-16 alpha-methyl-4-pregnene-3,20-dione",1251-28-1,LD50 oral (rat): > 2000 mg/kg bw [Stark 1996a]LD50 dermal (rat): > 2000 mg/kg bw [Stark 1996b] ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27c267b2-30d0-412e-a9c2-8b7fbe85e078/documents/IUC5-bd364eaa-ef73-4458-94df-8920c70d6013_ce2045ca-50a8-4c9a-b6d1-2493a7b306d0.html,,,,,, "21-Acetoxy-6 alpha-fluoro-16 alpha-methyl-4-pregnene-3,20-dione",1251-28-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27c267b2-30d0-412e-a9c2-8b7fbe85e078/documents/IUC5-bd364eaa-ef73-4458-94df-8920c70d6013_ce2045ca-50a8-4c9a-b6d1-2493a7b306d0.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "21-Acetoxy-6 alpha-fluoro-16 alpha-methyl-4-pregnene-3,20-dione",1251-28-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27c267b2-30d0-412e-a9c2-8b7fbe85e078/documents/IUC5-bd364eaa-ef73-4458-94df-8920c70d6013_ce2045ca-50a8-4c9a-b6d1-2493a7b306d0.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "21-Hydroxy-16 alpha-methyl-4-pregnene-3,20-dione",39987-86-5,"ZK 9340 is harmful after single oral exposure (LD50 cut-off, rat: > 300 - < 500 mg/kg bw). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d66c960d-cd68-403d-990a-dd0377268155/documents/IUC5-219cf4a3-1693-4968-92e5-84be55ff7bf3_6b8b5e47-f8bd-4b2e-a064-a64ce78dcc22.html,,,,,, "(9beta,11beta)-3,20-dioxo-9,11-epoxypregna-1,4,16-trien-21-yl acetate",103466-44-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e1a4aec-9179-48e5-b077-13aecc6608b3/documents/IUC5-23d2f925-c1a3-423a-8155-e512d5d88259_c1264c40-6ccf-41b1-a1ea-737c503cab29.html,,oral,LD50,393 mg/kg bw,, "17-Acetoxy-1,4,6-pregnatriene-3,20-dione",2668-75-9,"Oral (Rat, OECD TG 423): LD50 > 2000 mg/kg [Schering AG, Report No. X090 -draft-, 1996-06-11] Dermal (Rat, OECD TG 402): LD50 > 2000 mg/kg [Schering AG, Report No. X112 -draft-, 1996-09-26] ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27046052-88e7-4dcf-9764-490358e8bf93/documents/IUC5-e7e8acbb-6399-4b7a-ad30-394ee2223f70_5970b991-0134-457f-b8de-f6eeee1469ec.html,,,,,, "17-Acetoxy-1,4,6-pregnatriene-3,20-dione",2668-75-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27046052-88e7-4dcf-9764-490358e8bf93/documents/IUC5-e7e8acbb-6399-4b7a-ad30-394ee2223f70_5970b991-0134-457f-b8de-f6eeee1469ec.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "17-Acetoxy-1,4,6-pregnatriene-3,20-dione",2668-75-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/27046052-88e7-4dcf-9764-490358e8bf93/documents/IUC5-e7e8acbb-6399-4b7a-ad30-394ee2223f70_5970b991-0134-457f-b8de-f6eeee1469ec.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "17-Hydroxy-1,4,6-pregnatriene-3,20-dione",66212-25-7,"Oral (Rat, GLP, OECD TG 423): LD50 > 2000 mg/kg  [Schering AG, Report No. X174 -draft-, 1996-10-21] Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61488292-80d5-47d5-9de8-7f9bdcc0f2e2/documents/IUC5-8b18d95a-8989-475c-9e9c-577b51699962_8ffac50c-21eb-4414-be47-afeef174cb15.html,,,,,, "17-Hydroxy-1,4,6-pregnatriene-3,20-dione",66212-25-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61488292-80d5-47d5-9de8-7f9bdcc0f2e2/documents/IUC5-8b18d95a-8989-475c-9e9c-577b51699962_8ffac50c-21eb-4414-be47-afeef174cb15.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "20,20-Ethylenedioxy-17-hydroxy-1,4,6-pregnatrien-3-one",93771-36-9,"Oral (Rat, OECD TG 423): LD50 > 2000 mg/kg [Schering AG, Report No. X522 -draft-, 2001-01-17] Dermal (Rat, OECD TG 402): LD50 > 2000 mg/kg [Schering AG, Report No. X520 -draft-, 2001-02-14]   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study has Klimisch score 1. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study has Klimisch score 1. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6567fc2a-01a7-47d0-9d32-6327c9ccfaf5/documents/IUC5-71b13fb8-974a-4826-bd8c-e1f29e400eed_caed739e-7c7a-427c-98d6-d6f814524f6a.html,,,,,, "20,20-Ethylenedioxy-17-hydroxy-1,4,6-pregnatrien-3-one",93771-36-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6567fc2a-01a7-47d0-9d32-6327c9ccfaf5/documents/IUC5-71b13fb8-974a-4826-bd8c-e1f29e400eed_caed739e-7c7a-427c-98d6-d6f814524f6a.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "20,20-Ethylenedioxy-17-hydroxy-1,4,6-pregnatrien-3-one",93771-36-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6567fc2a-01a7-47d0-9d32-6327c9ccfaf5/documents/IUC5-71b13fb8-974a-4826-bd8c-e1f29e400eed_caed739e-7c7a-427c-98d6-d6f814524f6a.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "6 alpha-Fluoro-11 beta-hydroxy-16 alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione",36130-02-6," In analogy to fluocortolone, the structurally analogue substance fluocortolone-21-valerate is considered to cause organ damage after repeated administration to test animals. In systemic tolerance studies with fluocortolone involving repeated administration of both subcutaneous and oral doses in rats and dogs for 4 to 80 weeks, typical glucocorticoid effects were observed: degeneration of lymphatic tissue, suppression of the adrenal cortex, impairment of the hematogenic tissue (bone marrow) (Dres et al., 1975; Günzel et al., 1976; Staben, 1979; Woodard et al., 1966, 1967, 1969). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16757aac-628b-41d0-b426-b592949a180d/documents/13980b06-2abb-4468-bb95-6f9ae1b70f06_f0ffb504-361b-4b55-9817-128b109b0a09.html,,,,,, "6 alpha-Fluoro-11 beta-hydroxy-16 alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione",36130-02-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16757aac-628b-41d0-b426-b592949a180d/documents/13980b06-2abb-4468-bb95-6f9ae1b70f06_f0ffb504-361b-4b55-9817-128b109b0a09.html,Chronic toxicity – systemic effects,oral,LOAEL,0.1 mg/kg bw/day,,rat "6 alpha-Fluoro-11 beta-hydroxy-16 alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione",36130-02-6,"The acute oral toxicity (LD50, rat) of fluocortolone-21-valerate is 245 mg/kg bw based on an acute rat study with the read-across substance fluocortolone (Günzel and Richter, 1965). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16757aac-628b-41d0-b426-b592949a180d/documents/78e8bcf0-b102-44be-92d3-633889cb15cd_f0ffb504-361b-4b55-9817-128b109b0a09.html,,,,,, "6 alpha-Fluoro-11 beta-hydroxy-16 alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione",36130-02-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16757aac-628b-41d0-b426-b592949a180d/documents/78e8bcf0-b102-44be-92d3-633889cb15cd_f0ffb504-361b-4b55-9817-128b109b0a09.html,,oral,LD50,245 mg/kg bw,adverse effect observed, "9 alpha-Bromo-6 alpha-fluoro-11 beta-hydroxy-16 alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione",54605-02-6," The acute oral toxicity (LD50) of bromhydrin-valerate in rats is 3100 mg/kg bw based on an acute rat study with the read-across substance diflucortolone-21-valerate (Geretzki and Richter, 1973). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a4ad9db-ed33-4362-9bce-29ee2d6a2f27/documents/030d1a69-d6c5-4f5d-afdd-f5ab1d3a26aa_423a8569-b83a-4192-ba71-53cccffd9649.html,,,,,, "9 alpha-Bromo-6 alpha-fluoro-11 beta-hydroxy-16 alpha-methyl-21-valeryloxy-1,4-pregnadiene-3,20-dione",54605-02-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a4ad9db-ed33-4362-9bce-29ee2d6a2f27/documents/030d1a69-d6c5-4f5d-afdd-f5ab1d3a26aa_423a8569-b83a-4192-ba71-53cccffd9649.html,,oral,LD50,"3,100 mg/kg bw",no adverse effect observed, Prometryn,7287-19-6,"- Oral: NOEL = 200 ppm (both sexes), equivalent to dose levels of 8.3 mg/kg bw/day for males and 8.1 mg/kg bw/day for females, dogs, 3 months, OECD 409, Moysan 1990. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP compliant OECD 409 study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd0e4f81-76db-4118-ab4f-88dc559ff5e0/documents/402e51b3-36d2-4fe9-9bdf-9656da054337_87e6dc7d-a013-4c8c-a2ac-6c1d02ca19e6.html,,,,,, Prometryn,7287-19-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd0e4f81-76db-4118-ab4f-88dc559ff5e0/documents/402e51b3-36d2-4fe9-9bdf-9656da054337_87e6dc7d-a013-4c8c-a2ac-6c1d02ca19e6.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rabbit Prometryn,7287-19-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd0e4f81-76db-4118-ab4f-88dc559ff5e0/documents/402e51b3-36d2-4fe9-9bdf-9656da054337_87e6dc7d-a013-4c8c-a2ac-6c1d02ca19e6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,8.1 mg/kg bw/day,,dog Prometryn,7287-19-6," - Oral: LD50 >2000 mg/kg bw, female, rat, according to OECD 425, Moore 2004 - Inhalation: LC50 >2.17 mg/L, males/female, rat, according to OECD 403, Pinto 2004 - Dermal: LD50 >2000 mg/kg bw, male/female, rat, according to OECD 402, Moore 2004 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd0e4f81-76db-4118-ab4f-88dc559ff5e0/documents/649d553d-8c73-492b-a095-06746fb1abc5_87e6dc7d-a013-4c8c-a2ac-6c1d02ca19e6.html,,,,,, Prometryn,7287-19-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd0e4f81-76db-4118-ab4f-88dc559ff5e0/documents/649d553d-8c73-492b-a095-06746fb1abc5_87e6dc7d-a013-4c8c-a2ac-6c1d02ca19e6.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Prometryn,7287-19-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd0e4f81-76db-4118-ab4f-88dc559ff5e0/documents/649d553d-8c73-492b-a095-06746fb1abc5_87e6dc7d-a013-4c8c-a2ac-6c1d02ca19e6.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Prometryn,7287-19-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd0e4f81-76db-4118-ab4f-88dc559ff5e0/documents/649d553d-8c73-492b-a095-06746fb1abc5_87e6dc7d-a013-4c8c-a2ac-6c1d02ca19e6.html,,inhalation,discriminating conc.,"2,170 mg/m3",no adverse effect observed, prop-2-en-1-yl (2E)-3-phenylprop-2-enoate,56289-56-6,Acute oral toxicity: OECD TG 401: 1520 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ba65be5-274d-4384-92fb-bc6b7526850e/documents/0ff05a2c-e001-41e7-8a5a-3ba4bb90318a_0a7acebd-9fd3-4d5f-a444-c8569d69f069.html,,,,,, prop-2-en-1-yl (2E)-3-phenylprop-2-enoate,56289-56-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2ba65be5-274d-4384-92fb-bc6b7526850e/documents/0ff05a2c-e001-41e7-8a5a-3ba4bb90318a_0a7acebd-9fd3-4d5f-a444-c8569d69f069.html,,oral,LD50,"1,520 mg/kg bw",adverse effect observed, "2,2-dimethyl-3-oxopropyl acetate",16184-79-5, Acute toxicity: oral The test item did not induce mortality following a single oral administration to rats at a dose of 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6619273e-aabb-4e8a-ad9d-9426f9800845/documents/03ce52a6-154a-40b1-bfc2-db9f674ef970_01aa9d0f-22f2-4f30-a100-0cc791564128.html,,,,,, "2,2-dimethyl-3-oxopropyl acetate",16184-79-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6619273e-aabb-4e8a-ad9d-9426f9800845/documents/03ce52a6-154a-40b1-bfc2-db9f674ef970_01aa9d0f-22f2-4f30-a100-0cc791564128.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-hydroxy-N,N-dimethyl-propanamide",35123-06-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline and GLP compliant study. Reliable without restriction. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9737b974-eae7-44c3-8402-27f647560d66/documents/7995dd08-d8f5-4cc5-8d7e-17eee15b8be4_c791a1de-09ed-4f3c-ab06-b3f559531285.html,,,,,, "2-hydroxy-N,N-dimethyl-propanamide",35123-06-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9737b974-eae7-44c3-8402-27f647560d66/documents/7995dd08-d8f5-4cc5-8d7e-17eee15b8be4_c791a1de-09ed-4f3c-ab06-b3f559531285.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "2-hydroxy-N,N-dimethyl-propanamide",35123-06-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP and guideline compliant study. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): GLP and guideline compliant study. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): GLP and guideline compliant study. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9737b974-eae7-44c3-8402-27f647560d66/documents/c1143897-e591-48c1-914b-3e9a648ecd7f_c791a1de-09ed-4f3c-ab06-b3f559531285.html,,,,,, "2-hydroxy-N,N-dimethyl-propanamide",35123-06-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9737b974-eae7-44c3-8402-27f647560d66/documents/c1143897-e591-48c1-914b-3e9a648ecd7f_c791a1de-09ed-4f3c-ab06-b3f559531285.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-hydroxy-N,N-dimethyl-propanamide",35123-06-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9737b974-eae7-44c3-8402-27f647560d66/documents/c1143897-e591-48c1-914b-3e9a648ecd7f_c791a1de-09ed-4f3c-ab06-b3f559531285.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-hydroxy-N,N-dimethyl-propanamide",35123-06-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9737b974-eae7-44c3-8402-27f647560d66/documents/c1143897-e591-48c1-914b-3e9a648ecd7f_c791a1de-09ed-4f3c-ab06-b3f559531285.html,,inhalation,LC50,5.004 mg/m3,no adverse effect observed, "3-amino-2,2-dimethylpropanamide",324763-51-1,"rat, oral: NOEL = 316 mg/ kg bw/day; NOAEL >= 1000 mg/kg bw/day (OECD guideline 407) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7eeb22b3-e861-4bc1-af27-f7044d50df39/documents/IUC5-160770f8-3d46-4147-ac86-e88672c76f4d_e8cbc5b5-0f34-42c6-80df-a60e2e02845c.html,,,,,, "3-amino-2,2-dimethylpropanamide",324763-51-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7eeb22b3-e861-4bc1-af27-f7044d50df39/documents/IUC5-160770f8-3d46-4147-ac86-e88672c76f4d_e8cbc5b5-0f34-42c6-80df-a60e2e02845c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3-amino-2,2-dimethylpropanamide",324763-51-1,"Oral: LD50 > 2000 mg/kg bw, (rat, according to EU Method B.1 tris)Dermal: LD50 > 2000 mg/kg bw (rat, according to EU Method B.3 and OECD guideline 402) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7eeb22b3-e861-4bc1-af27-f7044d50df39/documents/IUC5-7cbb1c92-ab2c-47e6-a8ef-4dcd25846c8b_e8cbc5b5-0f34-42c6-80df-a60e2e02845c.html,,,,,, "3-amino-2,2-dimethylpropanamide",324763-51-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7eeb22b3-e861-4bc1-af27-f7044d50df39/documents/IUC5-7cbb1c92-ab2c-47e6-a8ef-4dcd25846c8b_e8cbc5b5-0f34-42c6-80df-a60e2e02845c.html,,oral,LD50,"2,000 mg/kg bw",, "3-amino-2,2-dimethylpropanamide",324763-51-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7eeb22b3-e861-4bc1-af27-f7044d50df39/documents/IUC5-7cbb1c92-ab2c-47e6-a8ef-4dcd25846c8b_e8cbc5b5-0f34-42c6-80df-a60e2e02845c.html,,dermal,LD50,"2,000 mg/kg bw",, N-Isobutyryl-thiourea,6965-58-8,"Two studies are availbale on the acute oral toxicty of N-Isobutyryl-thiourea. They were performed according to OECD 423 and OECD 425. In conclusion, the LD50 of N-Isobutyrylthiourea is 3.1 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2ab8000-ba45-41d3-9ea1-a7e4c7bbe2ce/documents/IUC5-c530c61b-4e64-4e26-a8d0-e72f12782ff6_54bb0965-deda-4f32-849a-0bbcce4b18d1.html,,,,,, N-Isobutyryl-thiourea,6965-58-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2ab8000-ba45-41d3-9ea1-a7e4c7bbe2ce/documents/IUC5-c530c61b-4e64-4e26-a8d0-e72f12782ff6_54bb0965-deda-4f32-849a-0bbcce4b18d1.html,,oral,LD50,3.1 mg/kg bw,adverse effect observed, "1,3,5-Tris(2,2-dimethylpropionylamino)benzene",745070-61-5,No adverse effects were evident after 28- and 90 days of daily dosing up to the highest dose of approximately 1000 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/293e1ce9-5a42-452e-9206-eff7bee2e2fe/documents/IUC5-4b6cc464-5ef9-47c9-a73f-5f90ce69f8aa_baae661c-31f0-47f0-b546-94666a70a834.html,,,,,, "1,3,5-Tris(2,2-dimethylpropionylamino)benzene",745070-61-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/293e1ce9-5a42-452e-9206-eff7bee2e2fe/documents/IUC5-4b6cc464-5ef9-47c9-a73f-5f90ce69f8aa_baae661c-31f0-47f0-b546-94666a70a834.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,3,5-Tris(2,2-dimethylpropionylamino)benzene",745070-61-5,"Oral:LD50 (Wistar rat) > 2000 mg/kg bw (OECD TG 423, GLP compliant) (Testing Lab.: RCC Ltd., 2005; Study Owner: BASF SE)Dermal:LD50 (Wistar rat) > 2000 mg/kg bw (OECD TG 402, GLP compliant) (Testing Lab.: RCC Ltd., 2005; Study Owner: BASF SE)Inhalation: no data available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/293e1ce9-5a42-452e-9206-eff7bee2e2fe/documents/IUC5-53e34aea-c26d-4024-accd-e97ec936c426_baae661c-31f0-47f0-b546-94666a70a834.html,,,,,, "1,3,5-Tris(2,2-dimethylpropionylamino)benzene",745070-61-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/293e1ce9-5a42-452e-9206-eff7bee2e2fe/documents/IUC5-53e34aea-c26d-4024-accd-e97ec936c426_baae661c-31f0-47f0-b546-94666a70a834.html,,oral,LD50,"2,000 mg/kg bw",, "1,3,5-Tris(2,2-dimethylpropionylamino)benzene",745070-61-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/293e1ce9-5a42-452e-9206-eff7bee2e2fe/documents/IUC5-53e34aea-c26d-4024-accd-e97ec936c426_baae661c-31f0-47f0-b546-94666a70a834.html,,dermal,LD50,"2,000 mg/kg bw",, "Propanamide, N-[2-(4-phenoxyphenoxy)ethyl]-",104825-66-3," LD50 : 3750 mg/kg bw (rats, oral) (equivalent or similar to OECD 401, non-GLP, K, Rel. 2) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7881606c-1301-4813-a613-5db37c18dc27/documents/7760e212-02b9-4964-9aa1-1c2f708ff08b_4f6d57ed-2782-4b12-b3a2-3dac7b9cb0df.html,,,,,, "Propanamide, N-[2-(4-phenoxyphenoxy)ethyl]-",104825-66-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7881606c-1301-4813-a613-5db37c18dc27/documents/7760e212-02b9-4964-9aa1-1c2f708ff08b_4f6d57ed-2782-4b12-b3a2-3dac7b9cb0df.html,,oral,LD50,"3,750 mg/kg bw",adverse effect observed, "2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane",382-26-3," An oral toxicity study performed according to OECD 423 guideline, a dermal toxicity study performed according to OECD 402 guideline and an inhalation toxicity study performed according to OECD 403 guideline are reported. According to Regulation EC No. 1272/2008, the substance is classified as following: Acute oral toxicity Category 3 Acute Inhalation Toxicity Category 2. The substance does not meet the classification criteria for Acute Dermal Toxicity ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3be94ac0-0e5b-48cd-a6a6-2bbf0dbd168c/documents/IUC5-32a60cd0-d112-41c1-88ea-c7ecb82e3ee3_2775c5c7-3582-4f83-abb4-021acd6e236d.html,,,,,, "2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane",382-26-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3be94ac0-0e5b-48cd-a6a6-2bbf0dbd168c/documents/IUC5-32a60cd0-d112-41c1-88ea-c7ecb82e3ee3_2775c5c7-3582-4f83-abb4-021acd6e236d.html,,oral,discriminating dose,50 mg/kg bw,adverse effect observed, "2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane",382-26-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3be94ac0-0e5b-48cd-a6a6-2bbf0dbd168c/documents/IUC5-32a60cd0-d112-41c1-88ea-c7ecb82e3ee3_2775c5c7-3582-4f83-abb4-021acd6e236d.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "2-[difluoro(methoxy)methyl]-1,1,1,3,3,3-hexafluoropropane",382-26-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3be94ac0-0e5b-48cd-a6a6-2bbf0dbd168c/documents/IUC5-32a60cd0-d112-41c1-88ea-c7ecb82e3ee3_2775c5c7-3582-4f83-abb4-021acd6e236d.html,,inhalation,LC50,"1,060 mg/m3",adverse effect observed, "1,1,2,2,3,3-hexafluoro-1-trifluoromethoxy-3-trifluorovinyloxypropane",40573-09-9,A repeat-dose oral toxicity study has been conducted on MV31. The results of the study are: A 28 day oral gavage study resulted in a NOAEL of 450 mg/kg/day when tested according to OECD 407. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e6a535d-285f-4d03-ab4e-020bbd0b978c/documents/IUC5-2e05d52e-f0b8-43e1-9b81-df7bd1341767_916f309c-2e8d-452d-900c-bcaec4ff438d.html,,,,,, "1,1,2,2,3,3-hexafluoro-1-trifluoromethoxy-3-trifluorovinyloxypropane",40573-09-9,An acute oral toxicity study has been conducted on MV31. The result of the study was:Acute oral toxicity is greater than 2000 mg/kg when tested according to OECD 423. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e6a535d-285f-4d03-ab4e-020bbd0b978c/documents/IUC5-ccea7dda-f350-4bae-acd4-86f683137e68_916f309c-2e8d-452d-900c-bcaec4ff438d.html,,,,,, "Propane-1,2-diyl diacetate",623-84-7," A 28-day dermal GLP study according to or equivalent to OECD guideline 410 has been conducted with PGDA. A TK/metabolism study comparing molar equivalent amounts of radiolabeled PGDA and propylene glycol showed similar absorption and elimination parameters and indicated rapid metabolism of PGDA to propylene glycol (PG) and presumable acetic acid (not the labeled portion of PGDA). Therefore, available repeated dose toxicity studies of propylene glycol is included in this summary. The repeated dose toxicity of monopropylene glycol by oral and inhalatory exposure routes is low. The lowest NOAEL of 1700 mg/kg bw/day was obtained in a chronic study with rats receiving monopropylene glycol in diet. In the subchronic inhalation study with rats, exposed to aerosol of monopropylene glycol at concentration levels of 160-2200 mg/m3, reported nasal haemorraghic discharge and ocular discharge occurred in all dose groups; this was accompanied by microscopically observed prominent goblet cell and/or mucus production in mid- and high-concentration groups. Based on these findings, the lowest dose level of 160 mg/m3 is considered a LOAEL for local effects. For systemic effects, a NOAEL of 1000 mg/m3 was established, based on the reduced body weight and decreased food consumption in high-dose females. The other metabolite of PGDA is acetic acid (AA) which does not have standard/guideline study databut due to its use in the food industry (GRAS classification) and presence in vinegar, it has been determined to have low toxicological concern. See read across document for summaries of non-standard studies using acetic acid/vinegar.  The PGDA/PG TK study dosed animals with 500 mg/kg bw PGDA which is less than the limit dose of 1000 mg/kg. However, the acute toxicity data on PGDA shows that by all major dose routes there are no deaths at 2000 mg/kg bw or greater and up to the highest attainable vapor concentration. PGDA has also been dosed in a 28-day study and developmental toxicity study at the limit dose of 1000 mg/kg bw/day with no adverse findings which shows the same lack of adverse toxicity as propylene glycol and acetic acid. Therefore, this weight of evidence (very low acute toxicity, lack of systemic toxicity at 1000 mg/kg PGDA and rapid metabolism to propylene glycol and acetic acid) supports the use of the highest dose levels from the read across material propylene glycol. The justification for using data on the PGDA metabolite propylene glycol is provided in the read across document attached to Section 13 of the IUCLID dossier. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1085327-c96d-4f35-8fb7-4a0e435cf3be/documents/IUC5-137eedca-0103-40ae-8a90-17feead9cfd6_43cebff1-2493-4827-a7ca-1478623adf17.html,,,,,, "Propane-1,2-diyl diacetate",623-84-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1085327-c96d-4f35-8fb7-4a0e435cf3be/documents/IUC5-137eedca-0103-40ae-8a90-17feead9cfd6_43cebff1-2493-4827-a7ca-1478623adf17.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Propane-1,2-diyl diacetate",623-84-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1085327-c96d-4f35-8fb7-4a0e435cf3be/documents/IUC5-137eedca-0103-40ae-8a90-17feead9cfd6_43cebff1-2493-4827-a7ca-1478623adf17.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,310 mg/m3",,rat "Propane-1,2-diyl diacetate",623-84-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1085327-c96d-4f35-8fb7-4a0e435cf3be/documents/IUC5-137eedca-0103-40ae-8a90-17feead9cfd6_43cebff1-2493-4827-a7ca-1478623adf17.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,700 mg/kg bw/day",,rat "Propane-1,2-diyl diacetate",623-84-7,"GLP-studies according to OECD guidelines 401, 402 and 403 are available for PGDA. In addition, supporting studies (non-GLP) equivalent to OECD guidelines 401, 402 and 403 are available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1085327-c96d-4f35-8fb7-4a0e435cf3be/documents/IUC5-15d3afe5-81ba-4937-8558-ec2815a5808d_43cebff1-2493-4827-a7ca-1478623adf17.html,,,,,, "Propane-1,2-diyl diacetate",623-84-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1085327-c96d-4f35-8fb7-4a0e435cf3be/documents/IUC5-15d3afe5-81ba-4937-8558-ec2815a5808d_43cebff1-2493-4827-a7ca-1478623adf17.html,,oral,LD50,"5,000 mg/kg bw",, "Propane-1,2-diyl diacetate",623-84-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1085327-c96d-4f35-8fb7-4a0e435cf3be/documents/IUC5-15d3afe5-81ba-4937-8558-ec2815a5808d_43cebff1-2493-4827-a7ca-1478623adf17.html,,dermal,LD50,"2,000 mg/kg bw",, "Propane-1,2-diyl diacetate",623-84-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1085327-c96d-4f35-8fb7-4a0e435cf3be/documents/IUC5-15d3afe5-81ba-4937-8558-ec2815a5808d_43cebff1-2493-4827-a7ca-1478623adf17.html,,inhalation,LC50,"2,170 mg/m3",, "Propane-1,3-diyl bis(4-aminobenzoate)",57609-64-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Only one study available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2245512-99a8-4885-8734-40474e3c695d/documents/746a5ac7-cf7c-45f3-9dc3-6be0c2138cc8_5b949ebb-0d6e-45ae-a694-12924f9eb024.html,,,,,, "Propane-1,3-diyl bis(4-aminobenzoate)",57609-64-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2245512-99a8-4885-8734-40474e3c695d/documents/746a5ac7-cf7c-45f3-9dc3-6be0c2138cc8_5b949ebb-0d6e-45ae-a694-12924f9eb024.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Propane-1-thiol,107-03-9," There are no repeated dose toxicity data for n-propyl mercaptan, (1-propanethiol; CAS 107-03-9), therefore data were read-across from the structurally analogous substances tert-butyl mercaptan (2-methylpropane-2-thiol; CAS 75-66-1) and n-butyl mercaptan (1-butanethiol; CAS 109-79-5). 1-Propanethiol (NPM, target), 1-butanethiol (source) and 2-methylpropane-2-thiol (source) all contain a thiol (-SH) functional group with a branched or linear aliphatic carbon chain. In a combined repeated dose toxicity study with the reproduction / developmental toxicity screening test) with 2-methylpropane-2-thiol, conducted according to OECD Test Guideline 422 and in compliance with GLP, the NOAEL was concluded to be 50 mg/kg bw/day based on body weight reduction observed in female rats dosed at 200 mg/kg bw/day (MHLW, 2006).   In a 13-week inhalation toxicity study, conducted according to OECD Test Guideline 413 and in compliance with GLP, 2-methylpropane-2-thiol induced an increase of kidney weights in male rats exposed to 97 and 196 ppm and a chronic nephropathy in all males. The NOAEC for systemic toxicity is higher or equal to 196 ppm (equivalent to 721 mg/m3) (Ulrich, 1982a). In a 13-week inhalation toxicity study, conducted according to OECD Test Guideline 413 and in compliance with GLP, the concluded NOAEC for 1-butanethiol was 150 ppm (550 mg/m3 analytical) based on no adverse systemic effects observed up to the highest concentration tested (Ulrich, 1982a). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d14e150b-7246-4329-a151-307041caaab1/documents/212e1910-3397-4324-8d9a-df218f4b4cbf_6787bb65-b883-466a-8595-dbd608f847b4.html,,,,,, Propane-1-thiol,107-03-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d14e150b-7246-4329-a151-307041caaab1/documents/212e1910-3397-4324-8d9a-df218f4b4cbf_6787bb65-b883-466a-8595-dbd608f847b4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Propane-1-thiol,107-03-9," The first acute oral toxicity study, conducted according to a protocol similar to OECD 420 Test Guideline and prior to CLP, reported a LD50 value of 1790 mg/kg bw for propane-1-thiol (Fairchild, 1958). The second acute oral toxicity study, conducted according to a protocol similar to the now deleted OECD 401 Test Guideline and in compliance with GLP, reported a LD50 value of 1848 mg/kg bw for propane-1-thiol (UBTL, 1981). The key acute inhalation toxicity study, conducted according to a protocol similar to OECD 436 Test Guideline without information on GLP compliance, reported a LC50 value of greater than 5.663 mg/L for propane-1-thiol (Hardy, 1987). The first acute dermal toxicity study, conducted according to a protocol similar to OECD 402 and in compliance with GLP, reported a LD50 value greater than 2000 mg/kg bw for propane-1-thiol (Shapiro, 1985). The second acute dermal toxicity study, conducted according to a protocol similar to OECD 402 and in compliance with GLP, reported a LD50 value greater than 1680 mg/kg bw for propane-1-thiol (Moon, 1981). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d14e150b-7246-4329-a151-307041caaab1/documents/7ceca9f5-2b85-40b8-853b-248c29c4c66b_6787bb65-b883-466a-8595-dbd608f847b4.html,,,,,, Propane-1-thiol,107-03-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d14e150b-7246-4329-a151-307041caaab1/documents/7ceca9f5-2b85-40b8-853b-248c29c4c66b_6787bb65-b883-466a-8595-dbd608f847b4.html,,oral,LD50,"1,790 mg/kg bw",adverse effect observed, Propane-1-thiol,107-03-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d14e150b-7246-4329-a151-307041caaab1/documents/7ceca9f5-2b85-40b8-853b-248c29c4c66b_6787bb65-b883-466a-8595-dbd608f847b4.html,,dermal,LD50,"1,680 mg/kg bw",no adverse effect observed, Propane-1-thiol,107-03-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d14e150b-7246-4329-a151-307041caaab1/documents/7ceca9f5-2b85-40b8-853b-248c29c4c66b_6787bb65-b883-466a-8595-dbd608f847b4.html,,inhalation,LC50,"5,663 mg/m3",no adverse effect observed, Propane-2-thiol,75-33-2,"It is proposed to conduct a subchronic repeated-dose toxicity study on the registered substance. Considering the physicochemical properties and uses of the substance, the inhalation route was identified as the most appropriate route of exposure in accordance with Annex IX of REACH, Section 8.6.2.   Repeated-dose toxicity of butane-1-thiol (n-butyl mercaptan), butane-2-thiol (sec-butyl mercaptan) and 2-methyl-propane-2-thiol (tert-butyl mercaptan), structural analogue substances to propane-1-thiol and propane-2-thiol, has been investigated in 13-week inhalation toxicity studies (Ulrich, 1982a, 1983 and 1984; Kim et al., 2009) and for 2-methyl-propane-2-thiol in an oral combined repeated-dose/reproductive/developmental toxicity study in rats (MLHW, 2006). In the 13-week inhalation studies, the NOAECs were 367, 550 and 723 mg/m3 for butane-2-thiol, butane-1-thiol and 2-methyl-propane-2-thiol, respectively. In the oral repeated-dose toxicity study (OECD TG 422), the NOAEL was considered to be 50 mg/kg bw/day.   Inhalation route In a 90-day inhalation toxicity study, butane-2-thiol (sec-butyl mercaptan) was administered to 10 Sprague-Dawley rats/sex/concentration by dynamic whole body exposure at target concentrations of 0, 25, 100 and 400 ppm (0, 92.6, 367.4 and 1488.2 mg/m3 analytical, respectively) for 6 hours per day, 5 days/week for a total of 91 days (Kim et al., 2009). No treatment-related toxic symptoms or mortality were observed in any of the animals treated with butane-2-thiol during the experimental period.  In males, the amount of food consumed was significantly lower on Days 0 and 7 of treatment in the 400 ppm group (11.7 ± 3.9 and 20.7 ± 1.5 g) than in the control group (22.6 ± 2.4 and 24.3 ± 2.3 g). In females, food consumption of the group exposed to 400 ppm was also decreased significantly on Days 0 and 7 of treatment (9.6 ± 3.5 and 13.6 ± 1.8 g) than in the control group (18.2 ± 2.7 and 18.8 ± 3.3 g). Significant decreases in body weight gain were observed in females in the high concentration group and decreases in RBC, hemoglobin and hematocrit levels were reported in both male and female animals in the 400 ppm group. In males, the relative weights of the liver and kidneys in the 400 ppm group were increased significantly in a dose-dependent manner compared to those of the control group. In females, the relative weights of the kidneys, brain, lung, and heart in the 400 ppm group were also significantly increased in a dose-dependent manner compared to those of the control group. No gross pathological changes were observed at necropsy, however histopathological alterations observed predominantly in the 400 ppm group, included centrilobular hepatocyte hypertrophy in the liver of males (which corresponded with increased liver weights) and tubular hyaline droplets, granular cast, pyelonephritis, and tubular degeneration/regeneration in the kidneys (severe in male animals), extramedullary hematopoiesis and hemosiderin pigment in the spleen, and eosinophilic inclusions and mineralization in the nasal olfactory epithelium. Based on these findings the target organs of butane-2-thiol were determined to be the erythrocyte, kidneys, liver, and nasal turbinates in rats. The NOAEC is 100 ppm (367.4 mg/m3 analytical).   In a 13-week inhalation toxicity study, male and female Sprague-Dawley rats (15/sex/group) were exposed (whole body) to butane-1-thiol (n-butyl mercaptan) at target concentrations of 0, 10, 75 and 150 ppm (0, 33, 260 and 550 mg/m3 analytical, respectively) for six hours per day, five days per week (Ulrich, 1982a, 1983 and 1984). There were no deaths, clinical signs of toxicity, body weight changes, effects on urinalysis or any behavioral changes observed. One female died during week 3 of unknown cause and one male died of blood collection trauma after the 6 week blood collection. Female rats exhibited a statistically significant decrease in red blood cells when compared to controls at week 12 for the 75 ppm group and a similar decrease was noted for the 150 ppm group at weeks 6 and 12. A statistically significant elevation of neutrophils and a corresponding decrease of lymphocytes were noted for the 150 ppm group of females when compared to controls at week 12. None of these changes were considered to have shifted out of the normal range for rats and therefore were not considered to be biologically significant. No effects on hematology were observed in males. Lung weights were statistically elevated for males in the 75 and 150 ppm groups when compared to controls. The only microscopic finding attributable to the test material was an increase in alveolar macrophages of trace severity present among males and females of the high concentration (150 ppm) group only which was not considered as adverse. Eleven of 15 males and 12 of 15 females were affected. Based on the findings in this study, the NOAEC was 150 ppm (550 mg/m3 analytical).    In a 13-week inhalation toxicity study, male and female Sprague-Dawley rats (15/sex/dose) were exposed (whole body) to 2-methyl-propane-2-thiol (t-butyl mercaptan) at target concentrations 0, 10, 100 and 200 ppm (0, 33.2, 357.8 or 723 mg/m3 analytical, respectively) for six hours per day, five days per week (Ulrich, 1982a, 1983 and 1984). There were no deaths, clinical signs of toxicity or body weight changes observed. Blood urea nitrogen was statistically significantly different from the control group at the 6-week interval only for the 100 ppm exposure group; this change was not considered biologically relevant because it occurred at only one time interval. Statistically significant differences in erythrocyte count were only found in females at 6-week (100 ppm) and 12-week (100 and 200 ppm). The clinical pathology endpoints that differed from concurrent controls remained within the range of historical control values and were not considered to be biologically or toxicologically relevant. No compound-related macroscopic lesions were observed in any of the rats that were sacrificed at the termination of the study or those that died during the course of the study. There was a compound related increase in alveolar macrophages among males and females of the mid dose (100 ppm) and high dose (200 ppm) groups exposed to t-butyl mercaptan. At the mid dose level, 5 of 15 males and 3 of 15 females were affected. All lesions were trace in severity. At the high dose level 14 of 15 males and 12 of 15 females were affected. One male and one female were mild and all of the others were trace in severity. This lesion did not occur at the low dose level (10 ppm). Toxicologically significant increases in the mean weights of kidneys occurred in male rats exposed to 100 and 200 ppm. There was a compound and concentration-related increase in chronic nephrosis (varying degrees of multifocal degeneration of the proximal convoluted tubules, tubular regeneration, and inflammatory cell infiltration of the interstitium) in 14 of 15 animals at the high concentration (200 ppm). The lesion was also noted in 13 of 15 at the mid concentration (100 ppm) and 7 of 15 animals at the low concentration (10 ppm). However, findings in the kidneys of males were considered to be rat-specific with no relevance for human risk assessment. The NOAEC is higher or equal to 200 ppm (723 mg/m3, analytical).   Oral route In a combined repeated-dose/reproductive/developmental toxicity screening study (OECD TG 422) (MLHW, 2006), Crl:CD(SD) rats were administered 0, 10, 50 or 200 mg/kg bw/day of 2-methyl-propane-2-thiol (t-butyl mercaptan) by gavage in corn oil daily for 42-53 days and a satellite group in the control and high dose were monitored without dosing for 2-weeks for recovery. Group sizes were12 males and 17 females at 0 and 200 mg/kg bw/day and 12 males and 12 females at 10 and 50 mg/kg bw/day; 12 males and 12 females per group were used for mating and a recovery period of 14 days was established for 5 males and 5 non-mated females at 0 and 200 mg/kg bw/day. There was no mortality, clinical signs of toxicity or changes in functional observational battery measurements. Decreased body weight was observed in both sexes at 200 mg/kg bw/day throughout the administration period. During the recovery period, a lower body weight was observed in females, but body weight gains throughout the recovery period were similar to those of the control group. Decreased food consumption was observed in males at 200 mg/kg bw/day on days 4 and 15 of administration and in females at 200 mg/kg bw/day throughout the administration period. During the recovery period, females exhibited lower food consumption on day 1 of the recovery period, but food consumption after day 4 of the recovery period was similar to the control group. There was no effect on urinalysis measurements. For males, decreases in erythrocyte count, hemoglobin, hematocrit, and MCHC, an increase in platelet count, prolonged PT and APTT, decreaseda-1-globulin, glucose and chlorine, and increaseda-2-globulin, albumin, g-GTP, total cholesterol, and phospholipids were observed at 200 mg/kg bw/day. Slight increases in total cholesterol and phospholipids and a decrease in MCHC were observed at 50 mg/kg bw/day. During the recovery period, decreases in hemoglobin and MCHC and an increase in reticulocyte ratio were observed at 200 mg/kg bw/day. For females, decreased erythrocyte count, increased reticulocyte ratio, decreases ina-1-globulin and glucose and increases in total protein, A/G ratio, albumin, total cholesterol, and phospholipids were observed at 200 mg/kg bw/day. A shortening of the APTT was observed at 50 and 200 mg/kg bw/day, and an increase in total cholesterol was observed at 50 mg/kg bw/day. During the recovery period, increases in MCV and MCH, a decrease in MCHC and a decrease in creatinine were observed at 200 mg/kg bw/day. At necropsy, enlargement and discoloration of the kidneys were observed in 1, 3, and 4 males at 10, 50, and 200 mg/kg bw/day, respectively and liver enlargement was observed in 2 males at 200 mg/kg bw/day; after the recovery period, kidney enlargement was observed in 1 male at 200 mg/kg bw/day. No gross findings were recorded for females. Increases in absolute and relative liver weights were observed in males (50 and 200 mg/kg bw/day) and females (200 mg/kg bw/day). Kidney weight in males at 50 and 200 mg/kg bw/day and relative weight at all doses were significantly increased. A decrease in absolute thymus weight was observed in males at 200 mg/kg bw/day. Following the recovery period, increased relative liver weight was observed in both sexes and increases in absolute and relative weights of the kidneys were observed in males at 200 mg/kg bw/day. Histopathological changes were observed in the liver and spleen of both sexes and in the kidneys of males including: hepatocellular centrilobular hypertrophy in males at 50 and 200 mg/kg bw/day and in females at 200 mg/kg bw/day; hemosiderin deposits in the red pulp in the spleen of both sexes at 200 mg/kg bw/day; periportal fatty degeneration of hepatocytes in males at 50 and 200 mg/kg bw/day; basophilic renal tubules and hyaline deposits in proximal tubular epithelial cells in the kidneys in males at all doses which were considered to be indicative ofa-2µ-globulin nephropathy. Following the recovery period, hemosiderin deposits were observed in the red pulp of the spleen of both sexes, basophilic renal tubules were observed in the kidneys in males, and periportal fatty degeneration of hepatocytes was observed in 1 male and 1 female at 200 mg/kg bw/day. Based on the decreased body weight gain in both males and females at 200 mg/kg bw/day, the slight reversible hematological changes and the slight or moderate reversible hepatocellular hypertrophy observed in males at 50 and 200 mg/kg bw/d and in females at 200 mg/kg bw/d, the LOAEL is considered to be 200 mg/kg bw/day and the NOAEL is considered to be 50 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/499dcfe9-9040-4d9a-9baa-73adc219a7fd/documents/IUC5-f112c440-15bd-4193-ac09-cbc15342284d_3d6df570-71c2-4ded-8749-081406d84031.html,,,,,, Propane-2-thiol,75-33-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/499dcfe9-9040-4d9a-9baa-73adc219a7fd/documents/IUC5-f112c440-15bd-4193-ac09-cbc15342284d_3d6df570-71c2-4ded-8749-081406d84031.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Propane-2-thiol,75-33-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/499dcfe9-9040-4d9a-9baa-73adc219a7fd/documents/IUC5-f112c440-15bd-4193-ac09-cbc15342284d_3d6df570-71c2-4ded-8749-081406d84031.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,367 mg/m3,,rat Propane-2-thiol,75-33-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/499dcfe9-9040-4d9a-9baa-73adc219a7fd/documents/IUC5-f112c440-15bd-4193-ac09-cbc15342284d_3d6df570-71c2-4ded-8749-081406d84031.html,Repeated dose toxicity – local effects,inhalation,NOAEC,367 mg/m3,adverse effect observed,rat Propane-2-thiol,75-33-2,"Propane-2-thiol (CAS 75-33-2) typically represents ca. 85% of the registered substance as imported or manufactured. Propane-1-thiol (CAS 107-03-9) is the main impurity, with a typical concentration of ca. 13.8%. Reports and publications used as sources in regards to the acute toxicity of Propane-2-thiol (CAS 75-33-2) provide limited details on the composition of the test items, preventing from checking their amount of Propane-1-thiol (CAS 107-03-9) present as an impurity.Consequently, experimental data on Propane-1-thiol (CAS 107-03-9) are provided along with the experimental data on Propane-2-thiol (CAS 75-33-2), i.e. the registered substance Based on the available data, the calculated acute toxicity estimates for the registered substance are approximately: - Oral route: 3066 mg/kg bw- Inhalation: > 20 mg/L air (vapour)- Dermal route: > 2000 mg/kg bwOral route- Propane-2-thiol (CAS 75-33-2)In a pre-guideline study (1977), male WBS/W rats were dosed (gavage) with propane-2-thiol at doses of 2000 and 5000 mg/kg bw and followed for 7 days. Mortality was 0/6 and 5/6 in the 2000 and 5000 mg/kg bw groups, respectively. Signs included hypotonia, ataxia, loss of righting reflex and body weight loss. Recovery was complete in 4 days. The LD50 was between 2000 and 5000 mg/kg bw and approximately 3730 mg/kg bw when calculated with the standard probit method.- Propane-1-thiol (CAS 107-03-9)In an acute oral toxicity study, groups of Wistar male rats (5/sex) were given a single oral dose of propane-1-thiol undiluted at doses of 1327, 1672, 2107, 2654, or 3344 mg/kg bw and observed for 15 days (Fairchild and Stokinger, 1958). Toxicity signs included sedative action, and maximal sublethal doses resulted in deep comatose sleep for approximately 48 hours. Diarrhea was also pronounced for the highest doses. Gross pathology generally did not show significant gross or microscopic tissue changes. Survivors of near lethal doses showed changes, which, although inconsistent, were indicative of liver and kidney damage. Body weights were not measured. The oral LD50was determined to be 1790 mg/kg bw in males.Inhalation route- Propane-2-thiol (CAS 75-33-2)In a key study similar to OECD TG 403 (Pence, 1983), Sprague-Dawley rats (5/sex) were exposed (whole-body) for four hours to propane-2-thiol at a measured concentration of 32.24 mg/l [10368 ppm]. Animals were observed for 14 days following the exposure. No mortality was observed. Beginning 30 minutes after initiation of exposures, all animals exhibited hyperactivity and ataxia, laboured respiration, prostration, and squinted eyes. All animals appeared normal throughout the rest of the study with the exception of one female exhibiting urine stains through Day 3 post-exposure. The males exhibited reduced mean body weights through Day 4 post-exposure and the females exhibited reduced mean body weights through Day 7 post-exposure. There was no evidence of macroscopic changes attributable to exposure. The 4-hour LC0 was > 32.24 mg/L (> 10368 pm).In a supporting study similar to OECD TG 403 (Hardy and Jackson, 1987), Sprague-Dawley rats (5/sex) were exposed (whole body) for four hours to a sham atmosphere or to propane-2-thiol at analytical concentration of 18,440 mg/m3 (5917 ppm). Animals were observed for 14 days following the exposure. There were no deaths. During exposure were observed, signs of irritant effects, including partial closing of eyes, reduced respiratory rate, abnormal respiratory movements, restlessness and adoption of a hunched body posture. An increased respiratory rate persisting for 1 day was observed post-exposure. Weight gain by rats exposed to propane-2-thiol was reduced for up to 2 days (males) or 5 days (females) post exposure. At necropsy, dark areas were observed on lungs of 3 rats exposed to propane-2-thiol and lung weight to bodyweight ratios was within normal limits. The LC0 (4-hour) is therefore in excess of 18.44 mg/l (5917 ppm).In a supporting study similar to OECD TG 403 (Hardy and Jackson, 1987), Sprague-Dawley rats (5/sex) were exposed (whole body) for four hours to a sham atmosphere or to propane-2-thiol at analytical concentration of 5,500 mg/m3 (1765 ppm) Animals were observed for 14 days following the exposure. There were no deaths. During exposure were observed, signs of irritant effects including closing or partial closing of the eyes, adoption of a hunched body posture and disturbances to the respiratory pattern. Weight gain by rats exposed to propane-2-thiol was reduced for up to 2 days post exposure. At necropsy, no treatment-related findings were observed and lung weight to bodyweight ratios was within normal limits. The LC0 (4-hour) is therefore in excess of 5.5 mg/l (1765 ppm).- Propane-1-thiol (CAS 107-03-9)In an acute inhalation toxicity study, groups of young adult albino Sprague-Dawley rats (5/sex) were exposed whole body to propane-1-thiol for 4 hours to an analytical concentration of 5.663 mg/L (Hardy and Jackson, 1987). Animals then were observed for 14 days. There were no deaths following exposure to propane-1-thiol vapor at a concentration of 5.663 mg/l. During exposure, there were signs of irritant effects including partial closing of the eyes, reduced respiration rate, abnormal respiration movements and adoption of a hunched body posture. Rats showed increased respiratory rate immediately following exposure, which subsequently returned to normal. Weight gain by rats exposed to propane-1-thiol was reduced for 1 day for males or up to 4 days for females post exposure. Lung weight to bodyweight ratios was within normal limits for all rats with the possible exception of one rat that was exposed to propane-1-thiol vapor. Macroscopic pathology revealed no treatment-related findings. The inhalation LC0 was determined to be greater than 5.663 mg/l in males and females.Male Wistar rats (6/group) were exposed (whole body) to propane-1-thiol for four hours at analytical concentrations of 3050, 4500, 8340, or 11260 ppm (9.5, 14.0, 26.0, 35.1 mg/L) (Fairchild and Stockinger, 1958). Although this study was conducted prior to adoption of GLP and guidelines for acute inhalation studies, there was sufficient detail to consider it comparable to OECD TG 403. All animals survived exposure at 3050 and 4500 ppm. At 8340 ppm, four of the five animals died; three died by 4-hours, and one by 24 hours. All 5 animals died within 4 hours following exposure to 11260 ppm. Increased respiration, restlessness, uncoordinated movement, staggering gait, muscular weakness, cyanosis and sedation were seen at higher concentrations, including those causing mortality. Irritation of the mucous membrane evidenced by rubbing of the eyes and nose, eye closure, watering of the eyes, cortical opacities and retracting of the head were the major clinical signs. The 4-hour LC50 was 7300 ppm (22.8 mg/L).In the same study, male Swiss mice were exposed (whole body) to propane-1-thiol for four hours at concentrations of 3050, 4500, 8340, 11260 ppm (9.51, 14.03, 26.01, 35.11 mg/L). All animals survived exposure at 3050 ppm. At 4500 ppm, 14 of the 20 animals died by 15 days. All animals died within 4 hours following exposure to 8340 and 11250 ppm. Increased respiration, restlessness, uncoordinated movement, staggering gait, muscular weakness, cyanosis and sedation were seen at higher concentrations, including those causing mortality. Irritation of the mucous membrane evidenced by rubbing of the eyes and nose, eye closure, watering of the eyes, cortical opacities and retracting of the head were the major clinical signs. The 4-hour LC50 was 4010 ppm (12.5 mg/L) (Fairchild and Stockinger, 1958).Dermal Route- Propane-2-thiol (CAS 75-33-2)In a pre-guideline study, each of six rats (male WBS/W) was treated dermally with 2000 mg/kg bw (2.46 ml/kg bw) of propane-2-thiol (Latven, 1977). Doses were applied under an impervious sleeve, which was pre-fitted upon the fur-clipped trunk of each rat. The sleeves were removed 24 hours later and the animals were then observed for seven days. Initial vocalization and weight losses lasting up to 4 days were observed. The LD0 was > 2000 mg/kg bw.- Propane-1-thiol (CAS 107-03-9)In an acute dermal toxicity study, groups of New Zealand Albino rabbits (5/sex) were dermally exposed to propane-1-thiol for 24 hours to 10% of body surface area at doses of 2000 mg/kg bw (Shapiro, 1985). Animals then were observed for 14 days. The rabbit that died on day 5 displayed the following clinical signs: lethargy, apparent loss of appetite, loss of gross reflexes, apparent drop in body temperature (i.e. cold to the touch) and loss of weight (1.0 kg). The surviving rabbits appeared active and behaved normally. Several rabbits, sporadically, did not eat on isolated days. The test application site on each of the rabbits was erythematous and in some instances, the skin was thickened. Gross necropsy of the deceased and surviving animals revealed evidence of pulmonary hemorrhage and discoloration of the liver and spleen. The dermal LD50 was determined to be greater than 2,000 mg/kg in males and females.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/499dcfe9-9040-4d9a-9baa-73adc219a7fd/documents/IUC5-8db32b65-e022-43bb-9abb-73b96ec31688_3d6df570-71c2-4ded-8749-081406d84031.html,,,,,, Propane-2-thiol,75-33-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/499dcfe9-9040-4d9a-9baa-73adc219a7fd/documents/IUC5-8db32b65-e022-43bb-9abb-73b96ec31688_3d6df570-71c2-4ded-8749-081406d84031.html,,oral,LD50,"3,066 mg/kg bw",no adverse effect observed, Propane-2-thiol,75-33-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/499dcfe9-9040-4d9a-9baa-73adc219a7fd/documents/IUC5-8db32b65-e022-43bb-9abb-73b96ec31688_3d6df570-71c2-4ded-8749-081406d84031.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Propane-2-thiol,75-33-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/499dcfe9-9040-4d9a-9baa-73adc219a7fd/documents/IUC5-8db32b65-e022-43bb-9abb-73b96ec31688_3d6df570-71c2-4ded-8749-081406d84031.html,,inhalation,discriminating conc.,"20,000 mg/m3",no adverse effect observed, "2,3,3,3-tetrafluoro-2-(trifluoromethyl)propanenitrile",42532-60-5,A repeat-dose inhalation toxicity study has been conducted on C4 F-isonitrile. The results of the study are: A 28 day inhalation study resulted in a NOAEC of 516 ppm when tested according to OECD 412. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0388b4b0-3789-480a-aa7d-81f5fec44267/documents/2348fb57-97de-4094-9ebe-902f9ecd7059_15147268-9933-4065-92db-81b850ccfc41.html,,,,,, "2,3,3,3-tetrafluoro-2-(trifluoromethyl)propanenitrile",42532-60-5,"Acute inhalation toxicity studies have been conducted on C4 F-isonitrile. The acute oral and dermal toxicity of C4 F-isonitrile was waived as the substance is a gas. The results of the studies are: Acute inhalation toxicity is greater than 10,000 ppm when tested according to a custom protocol.Acute inhalation toxicity is less than 15,000 ppm when tested according to a custom protocol. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0388b4b0-3789-480a-aa7d-81f5fec44267/documents/ec477350-bcf8-42d1-b914-8cdb5f59ebf1_15147268-9933-4065-92db-81b850ccfc41.html,,,,,, "Propanenitrile, 2-[bis(cyanomethyl)amino]-",185257-07-2,"oral28 d, rat: systemic toxicity: NOAEL < 10 mg/kg bw/d; LOAEL = 10 mg/kg bw/d due to impaired body weight/ bw gain/ food & water consumption in both sexes; neurotoxicity: NOAEL < 10 mg/kg bw/d; LOAEL = 10 mg/kg bw/d due to impaired motoneural parameters/ motor activities (GLP, OECD 407; BASF AG 2007)dermal no datainhalationno data ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/690c3e1d-478a-4d2d-b14b-3da0e2adb696/documents/IUC5-2b5a2d17-18b1-4df6-a437-db72c02e0bb1_ba5699dc-44f1-45fb-88a0-525a4bd28ac7.html,,,,,, "Propanenitrile, 2-[bis(cyanomethyl)amino]-",185257-07-2,"oralrat: LD50 >25 <200 mg/kg bw , no signs of toxicity (GLP, comp. OECD 423; BASF AG 1997) dermalrat: LD50 > 2000 mg/kg bw (GLP, OECD 402; BASF AG 2006)inhalationno data available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/690c3e1d-478a-4d2d-b14b-3da0e2adb696/documents/IUC5-6b8a2fde-3d9f-4d92-b7ef-e039865012ac_ba5699dc-44f1-45fb-88a0-525a4bd28ac7.html,,,,,, "Reaction mass of 3-({4-[2-(5,6-dichloro-1,3-benzothiazol-2-yl)diazen-1-yl]phenyl}(ethyl)amino)propanenitrile and 3-({4-[2-(6,7-dichloro-1,3-benzothiazol-2-yl)diazen-1-yl]phenyl}(ethyl)amino)propanenitrile",78564-87-1,The acute median lethal oral dose (LD50) to rats of Disperse Red 153 is above 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a36bd756-0594-456b-a4d3-c21ec9f6280c/documents/40504fbe-273b-4c58-83b7-6bc0a9ee3f6c_f011a5e4-2123-4ca7-931d-06328661851c.html,,,,,, 2-ethylhexyl (2R)-2-(4-chloro-2-methylphenoxy)propanoate,861229-15-4," oral: The NOAEL for the structurally comparable MCPP-P OE is 120 ppm, corresponding to 10.8 mg/kg bw/day for rats. inhalative: The NOAEC for male rats is 200mg/m3, the highest dose tested. dermal: The NOAEL (systemic and local) for rats is 1000 mg/kg bw/day, the highest dose level investigated. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f47f494-da10-4794-8446-9cc5a6cbcef3/documents/b99d0005-094d-4945-98ef-3e50b85885ef_41e3fadd-229e-480c-a428-4a320dfadfe6.html,,,,,, 2-ethylhexyl (2R)-2-(4-chloro-2-methylphenoxy)propanoate,861229-15-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f47f494-da10-4794-8446-9cc5a6cbcef3/documents/b99d0005-094d-4945-98ef-3e50b85885ef_41e3fadd-229e-480c-a428-4a320dfadfe6.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat 2-ethylhexyl (2R)-2-(4-chloro-2-methylphenoxy)propanoate,861229-15-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f47f494-da10-4794-8446-9cc5a6cbcef3/documents/b99d0005-094d-4945-98ef-3e50b85885ef_41e3fadd-229e-480c-a428-4a320dfadfe6.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,200 mg/m3,,rat 2-ethylhexyl (2R)-2-(4-chloro-2-methylphenoxy)propanoate,861229-15-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f47f494-da10-4794-8446-9cc5a6cbcef3/documents/b99d0005-094d-4945-98ef-3e50b85885ef_41e3fadd-229e-480c-a428-4a320dfadfe6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10.8 mg/kg bw/day,,rat 2-ethylhexyl (2R)-2-(4-chloro-2-methylphenoxy)propanoate,861229-15-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f47f494-da10-4794-8446-9cc5a6cbcef3/documents/b99d0005-094d-4945-98ef-3e50b85885ef_41e3fadd-229e-480c-a428-4a320dfadfe6.html,Repeated dose toxicity – local effects,dermal,NOAEL,5.6 mg/cm2,no adverse effect observed,rat 2-ethylhexyl (2R)-2-(4-chloro-2-methylphenoxy)propanoate,861229-15-4, oral: The LD50 for acute oral toxicity was 1400 mg/kg bw. inhalation: The LD50 for acute inhalation toxicity was >4.66 mg/L air (highest attainable concentration) dermal: The LD50 for acute dermal toxicity was >2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f47f494-da10-4794-8446-9cc5a6cbcef3/documents/842d1a73-d19b-4a0e-a067-2262f49486ac_41e3fadd-229e-480c-a428-4a320dfadfe6.html,,,,,, 2-ethylhexyl (2R)-2-(4-chloro-2-methylphenoxy)propanoate,861229-15-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f47f494-da10-4794-8446-9cc5a6cbcef3/documents/842d1a73-d19b-4a0e-a067-2262f49486ac_41e3fadd-229e-480c-a428-4a320dfadfe6.html,,oral,LD50,"1,400 mg/kg bw",adverse effect observed, 2-ethylhexyl (2R)-2-(4-chloro-2-methylphenoxy)propanoate,861229-15-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f47f494-da10-4794-8446-9cc5a6cbcef3/documents/842d1a73-d19b-4a0e-a067-2262f49486ac_41e3fadd-229e-480c-a428-4a320dfadfe6.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, 2-ethylhexyl (2R)-2-(4-chloro-2-methylphenoxy)propanoate,861229-15-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f47f494-da10-4794-8446-9cc5a6cbcef3/documents/842d1a73-d19b-4a0e-a067-2262f49486ac_41e3fadd-229e-480c-a428-4a320dfadfe6.html,,inhalation,discriminating conc.,"4,660 mg/m3",no adverse effect observed, "Propanoic acid, 2-[4-[4,6-bis([1,1'-biphenyl]-4-yl)-1,3,5-triazin-2-yl]-3-hydroxyphenoxy]-, isooctyl ester",204848-45-3,"Based on a previous range finder study, a subacute repeated dose toxicity study with oral administration to male and female rats was performed (OECD guideline 407). Animals received 15, 150 or 1000 mg/kg bw/day of the test item by gavage for 28 days. Clinical observation, testing of the neurobehaviour, clinical pathology and macroscopic as well as microscopic examination did not reveal any adverse findings. The NOAEL is considered to be 1000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Subacute oral administration as likely route of exposure (worst case), study according to OECD 407 and GLP, Klimisch 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6863eae5-f9c2-4d7f-b136-415699592201/documents/be261f6d-2307-4002-b3ab-7126e07ceb3f_b3743e00-111d-4fa3-9691-cdb6181b33d8.html,,,,,, "Propanoic acid, 2-[4-[4,6-bis([1,1'-biphenyl]-4-yl)-1,3,5-triazin-2-yl]-3-hydroxyphenoxy]-, isooctyl ester",204848-45-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6863eae5-f9c2-4d7f-b136-415699592201/documents/be261f6d-2307-4002-b3ab-7126e07ceb3f_b3743e00-111d-4fa3-9691-cdb6181b33d8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Propanoic acid, 2-[4-[4,6-bis([1,1'-biphenyl]-4-yl)-1,3,5-triazin-2-yl]-3-hydroxyphenoxy]-, isooctyl ester",204848-45-3,"Acute toxicity was assessed by oral and dermal administration of the test item to male and female rats at concentrations of 2000 mg/kg bw (OECD guideline 423 and 402, GLP). All animals survived until scheduled necropsy. Clinical and histo/pathological examination did not reveal any treatment related findings. Dermal application caused slight, transient skin irritation which resilved within post observation period. LD50 after oral and dermal administration is considered to be higher than 2000 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimsch 1, according OECD guideline 423 and GLP Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimsch 1, according OECD guideline 402 and GLP ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6863eae5-f9c2-4d7f-b136-415699592201/documents/57000319-5fb5-4df6-b195-80ecb1ce77cb_b3743e00-111d-4fa3-9691-cdb6181b33d8.html,,,,,, "Propanoic acid, 2-[4-[4,6-bis([1,1'-biphenyl]-4-yl)-1,3,5-triazin-2-yl]-3-hydroxyphenoxy]-, isooctyl ester",204848-45-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6863eae5-f9c2-4d7f-b136-415699592201/documents/57000319-5fb5-4df6-b195-80ecb1ce77cb_b3743e00-111d-4fa3-9691-cdb6181b33d8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Propanoic acid, 2-[4-[4,6-bis([1,1'-biphenyl]-4-yl)-1,3,5-triazin-2-yl]-3-hydroxyphenoxy]-, isooctyl ester",204848-45-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6863eae5-f9c2-4d7f-b136-415699592201/documents/57000319-5fb5-4df6-b195-80ecb1ce77cb_b3743e00-111d-4fa3-9691-cdb6181b33d8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, 2-cyano-2-methyl-propanoic acid methyl ester,72291-30-6,2 -Cyano-2 -methyl-propanoic acid-methyl ester was tested for acute oral toxicity in rats according to OECD Guideline 423. The median lethal dose of 2-Cyano-2-methyl-propanoic acid-methyl ester after oral administration was found to be greater than 2000 mg/kg body weight in female Wistar rats. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7fdb8fac-0ddd-422c-81a3-05934d35b6f3/documents/IUC5-e1eee59e-fde5-47e0-8371-c0a148424966_feac0578-dc8e-4b5e-8583-591cd35c10ee.html,,,,,, 2-cyano-2-methyl-propanoic acid methyl ester,72291-30-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7fdb8fac-0ddd-422c-81a3-05934d35b6f3/documents/IUC5-e1eee59e-fde5-47e0-8371-c0a148424966_feac0578-dc8e-4b5e-8583-591cd35c10ee.html,,oral,LD50,"2,000 mg/kg bw",, "Propanoic acid, 2-hydroxy-, (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl ester, (2S)-",61597-98-6,Read-across compound DL-menthol is not toxic in rats when applied daily by oral (feed) at a dose of 375 mg/kg bw/day for 103 weeks (data extrapolated to Menthyl lactate NOEL = 548 mg/kg bw/day). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6afa6a5-fcfd-40a7-b8f1-874aac1e818e/documents/IUC5-f306eced-7623-4c0e-a469-fd836ee33d82_4093f17a-6c68-46c6-9660-824fcf8d923f.html,,,,,, "Propanoic acid, 2-hydroxy-, (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl ester, (2S)-",61597-98-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6afa6a5-fcfd-40a7-b8f1-874aac1e818e/documents/IUC5-f306eced-7623-4c0e-a469-fd836ee33d82_4093f17a-6c68-46c6-9660-824fcf8d923f.html,Chronic toxicity – systemic effects,oral,NOAEL,548 mg/kg bw/day,,rat "Propanoic acid, 2-hydroxy-, (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl ester, (2S)-",61597-98-6,The substance was not acutely toxic via the oral or dermal route of exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6afa6a5-fcfd-40a7-b8f1-874aac1e818e/documents/IUC5-9ba227f7-f8cc-4966-aa08-ed75f73b6b93_4093f17a-6c68-46c6-9660-824fcf8d923f.html,,,,,, "Propanoic acid, 2-hydroxy-, (1R,2S,5R)-5-methyl-2-(1-methylethyl)cyclohexyl ester, (2S)-",61597-98-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6afa6a5-fcfd-40a7-b8f1-874aac1e818e/documents/IUC5-9ba227f7-f8cc-4966-aa08-ed75f73b6b93_4093f17a-6c68-46c6-9660-824fcf8d923f.html,,oral,LD50,"7,257 mg/kg bw",no adverse effect observed, "Propanoic acid, 2-hydroxy-, 2-ethylhexyl ester, (2S)-",186817-80-1," Suitable data is available for 2-ethylhexyl-S-lactate. A repeated dose oral toxicity study in rats and mice with 2-ethylhexanol at concentrations of 0, 25, 125, 250 and 500 mg/kg bw/day for 90 days similar with OECD guideline 408. In both studies, a NOAEL of 125 mg/kg bw/day was determined, which corresponds to 195 mg/kg bw/day 2-ethylhexyl-S-lactate. In a subchronic inhalation toxicity study conducted in accordance with OECD guideline 413, 2-ethylhexanol was administered to 10 male and 10 female Wistar rats by dynamic whole body exposure at concentrations of 15, 40 and 120 ppm (79.8, 212.8 and 638.4 mg/m³) for 6 hours per day, 5 days/week for a total of 90 days. No adverse effects have been observed. Thus, a NOAEC of 638.4 mg/m³ which corresponds to 998 mg/m³ of 2-ethylhexyl-S-lactate has been established. In a further inhalation study, conducted according to OECD guideline 412 with the target substance 2-ethylhexyl-S-lactate was administered to 5 male and 5 female Wistar derived rats/concentration by nose only exposure at concentrations of 0, 75, 200, 600 and 1800 mg/m³ for 6 hours per day, 5 days/week for a total of 28 days. In this study, local effects have been observed from 75 mg/m³ and systemic toxicity consisting of growth retardation, decreased food intake, and slight induction of hepatic peroxisome proliferation was noted at 1800 mg/m³. Thus, the NOAEC for systemic toxicity is considered to be 600 mg/m³. In the subacute inhalation study, there is a big distance between the doses. The systemic NOAEC in the subchronic study is between the high dose (1800 mg/m³) and the dose below (600 mg/m³) of the subacute inhalation study. Thus, the NOAEC of the subchronic study (998 mg/m³) is considered to be more precise and therefore, it is used for the calculation of the DNEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/279997a0-211c-48a8-bff7-ea8e0a3d569b/documents/IUC5-fc68f017-e6e0-401a-ba18-4c583189b1bd_ca43c01d-6dc8-45f6-be95-3f533db332bc.html,,,,,, "Propanoic acid, 2-hydroxy-, 2-ethylhexyl ester, (2S)-",186817-80-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/279997a0-211c-48a8-bff7-ea8e0a3d569b/documents/IUC5-fc68f017-e6e0-401a-ba18-4c583189b1bd_ca43c01d-6dc8-45f6-be95-3f533db332bc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,195 mg/kg bw/day,,rat "Propanoic acid, 2-hydroxy-, 2-ethylhexyl ester, (2S)-",186817-80-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/279997a0-211c-48a8-bff7-ea8e0a3d569b/documents/IUC5-fc68f017-e6e0-401a-ba18-4c583189b1bd_ca43c01d-6dc8-45f6-be95-3f533db332bc.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,998 mg/m3,,rat "Propanoic acid, 2-hydroxy-, 2-ethylhexyl ester, (2S)-",186817-80-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/279997a0-211c-48a8-bff7-ea8e0a3d569b/documents/IUC5-fc68f017-e6e0-401a-ba18-4c583189b1bd_ca43c01d-6dc8-45f6-be95-3f533db332bc.html,Repeated dose toxicity – local effects,inhalation,LOAEC,77 mg/m3,adverse effect observed,rat "Propanoic acid, 2-hydroxy-, 2-ethylhexyl ester, (2S)-",186817-80-1,2-Ethylhexyl-S-lactate is practically non-toxic by the oral and inhalation route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/279997a0-211c-48a8-bff7-ea8e0a3d569b/documents/IUC5-b5c0473b-9ead-4803-8929-c5b3baa0d6c9_ca43c01d-6dc8-45f6-be95-3f533db332bc.html,,,,,, "Propanoic acid, 2-hydroxy-, ammonium salt (1:1), (2S)-",137296-15-2," No data is available for ammonium-S-lactate itself. Therefore, available data from repeated dose toxicity studies conducted with suitable read-across partners were used in a weight-of-evidence approach to assess the specific target organ toxicity of the target substance. Based on the results, no classification for specific target organ toxicity is warranted for ammonium-S-lactate. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba4bf01c-7f1c-4fb2-bfa1-9c3e24fd07fa/documents/4f3a9dda-b3ca-4ff3-ae7d-9709d841501d_28fba2ad-0e1b-44b1-864c-5e8110c61b90.html,,,,,, "Propanoic acid, 2-hydroxy-, ammonium salt (1:1), (2S)-",137296-15-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba4bf01c-7f1c-4fb2-bfa1-9c3e24fd07fa/documents/4f3a9dda-b3ca-4ff3-ae7d-9709d841501d_28fba2ad-0e1b-44b1-864c-5e8110c61b90.html,Chronic toxicity – systemic effects,oral,NOAEL,415 mg/kg bw/day,,rat "Propanoic acid, 2-hydroxy-, ammonium salt (1:1), (2S)-",137296-15-2, In an acute oral toxicity study conducted according to OECD 420 and in an acute dermal toxicity study conducted according to OECD 402 young adult rats were exposed to the target substance. No mortality occurred after a single application of 2000 mg/kg bw in both studies within a 14 days observation period. Based on the results both the oral and the dermal LD50 exceed 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba4bf01c-7f1c-4fb2-bfa1-9c3e24fd07fa/documents/IUC5-c52b5be0-46cb-485d-81dd-df5632f2e608_28fba2ad-0e1b-44b1-864c-5e8110c61b90.html,,,,,, "Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters",1471312-26-1,"Based on read-across from Tetradecyl 2-hydroxypropionate (CAS No. 1323-03-1): NOAEL (oral, rat, 90d) = 500 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/572a786a-7991-46c8-812d-fac4113f0949/documents/IUC5-f4f22115-2051-456d-a443-3103257f40f6_141a499e-4c8a-4c12-875c-71be1068c984.html,,,,,, "Propanoic acid, 2-hydroxy-, C12-13-branched-alkyl esters",1471312-26-1,"Oral (OECD 401), rat: LD50 > 5000 mg/kg bw (limit test)Dermal (OECD 402), rabbit: LD50 > 2000 mg/kg bw (limit test) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/572a786a-7991-46c8-812d-fac4113f0949/documents/IUC5-5eb4e184-a4e2-4994-a554-4a5a291330b9_141a499e-4c8a-4c12-875c-71be1068c984.html,,,,,, "Red LF 6382/18L-R, notification presscake",790240-84-5,"Based on an oral subacute study with the substance registered, the NOAEL is considered to be 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b9408ea-273c-492d-ba5a-04fb2a8e64ad/documents/IUC5-1b6a1a8c-36c6-4422-9f50-4ffd2bb8a502_848fc5c7-32ca-4487-82e7-439ac411011a.html,,,,,, "Red LF 6382/18L-R, notification presscake",790240-84-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b9408ea-273c-492d-ba5a-04fb2a8e64ad/documents/IUC5-1b6a1a8c-36c6-4422-9f50-4ffd2bb8a502_848fc5c7-32ca-4487-82e7-439ac411011a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Red LF 6382/18L-R, notification presscake",790240-84-5,The LD50 oral of substance registered is greater than 2000 mg/kg bw. The LD50 dermal was greater than 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b9408ea-273c-492d-ba5a-04fb2a8e64ad/documents/IUC5-57b1eac4-9741-4800-a640-34a90e45e4b4_848fc5c7-32ca-4487-82e7-439ac411011a.html,,,,,, "Red LF 6382/18L-R, notification presscake",790240-84-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b9408ea-273c-492d-ba5a-04fb2a8e64ad/documents/IUC5-57b1eac4-9741-4800-a640-34a90e45e4b4_848fc5c7-32ca-4487-82e7-439ac411011a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Red LF 6382/18L-R, notification presscake",790240-84-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b9408ea-273c-492d-ba5a-04fb2a8e64ad/documents/IUC5-57b1eac4-9741-4800-a640-34a90e45e4b4_848fc5c7-32ca-4487-82e7-439ac411011a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, propyl (2S)-2-hydroxypropanoate,53651-69-7," No studies with the target substance propyl (S)-lactate itself are available for the assessment of repeated dose toxicity. However, an oral and an inhalation repeated dose toxicity study were conducted with suitable read-across partners which are thus used to assess the specific target organ toxicity of the target substance. Three sub-acute inhalation toxicity studies with ethyl (S)-lactate and butyl (S)-lactate revealed clear respiratory local effects, described as histopathological changes in the olfactory and respiratory epithelia. No clear systemic toxic effects were detected. Oral sub-chronic toxicity is addressed by a study conducted with a suitable read-across partner, calcium lactate pentahydrate. No adverse effects were reported after oral administration of calcium lactate pentahydrate via drinking water. The NOAEL in this study is 4500 mg/kg bw/day for both sexes (calculated from 50,000 mg/L by applying a conversion factor of 0.09 for rats as recommended in the EFSA guidance document [EFSA Journal 2012 (10(3): 2579]). Therefore, lactic acid/free lactate is of no systemic toxicological concern. In addition, in a sub-chronic repeated inhalation dose toxicity, propanol was administered to 10 B6C3F1 mice/sex/dose at concentrations of 0, 500, 1600 and 5200 ppm (0, 1.2, 3.9 and 12.8 mg/L) for 6 hours per day, 5 days/week for a total of 90 days. Based on the results, the NOAEC can be considered to be 5200 ppm (12.8 mg/L). In summary, no classification for repeated specific target organ toxicity is warranted for the target substance as no adverse systemic effects were observed up to the limit doses of the respective OECD test guidelines. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14fcce90-0ba6-42e1-91da-bfde073c7790/documents/IUC5-27f2b081-1621-421d-a2fe-12ab83ab2fcf_fa11b152-6718-4bc4-bd8c-38ec6329f7bb.html,,,,,, propyl (2S)-2-hydroxypropanoate,53651-69-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14fcce90-0ba6-42e1-91da-bfde073c7790/documents/IUC5-27f2b081-1621-421d-a2fe-12ab83ab2fcf_fa11b152-6718-4bc4-bd8c-38ec6329f7bb.html,Repeated dose toxicity – local effects,inhalation,NOAEC,150 mg/m3,adverse effect observed,rat propyl (2S)-2-hydroxypropanoate,53651-69-7," In an acute oral and dermal toxicity study conducted according to OECD guideline 401 and 402, groups of Wistar rats (5/sex) were given Propyl (S)-lactate (99.5 % purity) as a single dose of 2000 mg/kg bw. No mortality occurred and an oral and dermal LD50 value of greater than 2000 mg/kg bw, both in male and female rats, was determined in these studies. In acute inhalation toxicity studies conducted according to OECD guideline 403, groups of Wistar rats (5/sex) were exposed to the source substances Ethyl lactate, Ethylhexyl (S)-lactate and L(-) lactic acid for 4 hours. No mortality occurred in any study. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14fcce90-0ba6-42e1-91da-bfde073c7790/documents/IUC5-b88b59bb-eff3-4db7-90e1-d538ae7fec47_fa11b152-6718-4bc4-bd8c-38ec6329f7bb.html,,,,,, propyl (2S)-2-hydroxypropanoate,53651-69-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14fcce90-0ba6-42e1-91da-bfde073c7790/documents/IUC5-b88b59bb-eff3-4db7-90e1-d538ae7fec47_fa11b152-6718-4bc4-bd8c-38ec6329f7bb.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, propyl (2S)-2-hydroxypropanoate,53651-69-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14fcce90-0ba6-42e1-91da-bfde073c7790/documents/IUC5-b88b59bb-eff3-4db7-90e1-d538ae7fec47_fa11b152-6718-4bc4-bd8c-38ec6329f7bb.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, propyl (2S)-2-hydroxypropanoate,53651-69-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14fcce90-0ba6-42e1-91da-bfde073c7790/documents/IUC5-b88b59bb-eff3-4db7-90e1-d538ae7fec47_fa11b152-6718-4bc4-bd8c-38ec6329f7bb.html,,inhalation,LC50,"> 5,400 mg/m3",no adverse effect observed, "Methyl 3-[(2,2-dimethylbutanoyl)thio]propanoate",938063-63-9,Predicted oral LD50 value in the rat 1006 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1386235-6f06-42b4-acf4-39da4c100a86/documents/IUC5-467cb309-f599-403a-a0c5-a3b04497b795_082b0ba8-f4fa-4c75-a1d9-c3087f651b86.html,,,,,, "Methyl 3-[(2,2-dimethylbutanoyl)thio]propanoate",938063-63-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1386235-6f06-42b4-acf4-39da4c100a86/documents/IUC5-467cb309-f599-403a-a0c5-a3b04497b795_082b0ba8-f4fa-4c75-a1d9-c3087f651b86.html,,oral,LD50,"1,006 mg/kg bw",, Mixture of isomers,30025-38-8," A guideline 90-day chronic toxicity study in the rat supported by a guideline 28-day sub-chronic study, with confirmatory read-across from a reproductive toxicology study with a recovery period. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe13b7ed-1b30-4e97-8494-f6f351b8d19a/documents/IUC5-5f9621b2-99f9-4caf-b7ed-374f5325a0bf_33f3a104-f078-4896-b2ea-c5e42db88da9.html,,,,,, Mixture of isomers,30025-38-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe13b7ed-1b30-4e97-8494-f6f351b8d19a/documents/IUC5-5f9621b2-99f9-4caf-b7ed-374f5325a0bf_33f3a104-f078-4896-b2ea-c5e42db88da9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Mixture of isomers,30025-38-8,Acute p.o. toxicity study in the rat ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe13b7ed-1b30-4e97-8494-f6f351b8d19a/documents/IUC5-e94f480f-b885-4691-a332-f591fa563fad_33f3a104-f078-4896-b2ea-c5e42db88da9.html,,,,,, Mixture of isomers,30025-38-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe13b7ed-1b30-4e97-8494-f6f351b8d19a/documents/IUC5-e94f480f-b885-4691-a332-f591fa563fad_33f3a104-f078-4896-b2ea-c5e42db88da9.html,,oral,LD50,"4,659 mg/kg bw",, Mixture of isomers,30025-38-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe13b7ed-1b30-4e97-8494-f6f351b8d19a/documents/IUC5-e94f480f-b885-4691-a332-f591fa563fad_33f3a104-f078-4896-b2ea-c5e42db88da9.html,,dermal,discriminating dose,"2,009 mg/kg bw",, "reaction mass of 1-(1-Methyl-2-(1,7,7-trimethylbicyclo[2.2.1]hept-2-yloxy)ethoxy)-propan-2-ol and 1-(2-(1,7,7-trimethylbicyclo[2.2.1]hept-2-yloxy)propoxy)propan-2-ol and 2-(2-(1,7,7-trimethylbicyclo[2.2.1]hept-2-yloxy]propoxy)-propan-1-ol and 2-(1-Methyl-2-(1,7,7-trimethylbicyclo[2.2.1]hept-2-yloxy)ethoxy)propan-1-ol",958872-63-4,28-day study: OECD guideline 407. GLP. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f21fcdfc-473e-4ca0-a0b8-7f8dcaea80bd/documents/IUC5-1ba8ad50-2160-4acf-aa15-b8827d3e5642_c9981a7b-d7a0-4414-b20f-89d1c5593c9c.html,,,,,, "reaction mass of 1-(1-Methyl-2-(1,7,7-trimethylbicyclo[2.2.1]hept-2-yloxy)ethoxy)-propan-2-ol and 1-(2-(1,7,7-trimethylbicyclo[2.2.1]hept-2-yloxy)propoxy)propan-2-ol and 2-(2-(1,7,7-trimethylbicyclo[2.2.1]hept-2-yloxy]propoxy)-propan-1-ol and 2-(1-Methyl-2-(1,7,7-trimethylbicyclo[2.2.1]hept-2-yloxy)ethoxy)propan-1-ol",958872-63-4,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f21fcdfc-473e-4ca0-a0b8-7f8dcaea80bd/documents/IUC5-1ba8ad50-2160-4acf-aa15-b8827d3e5642_c9981a7b-d7a0-4414-b20f-89d1c5593c9c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "reaction mass of 1-(1-Methyl-2-(1,7,7-trimethylbicyclo[2.2.1]hept-2-yloxy)ethoxy)-propan-2-ol and 1-(2-(1,7,7-trimethylbicyclo[2.2.1]hept-2-yloxy)propoxy)propan-2-ol and 2-(2-(1,7,7-trimethylbicyclo[2.2.1]hept-2-yloxy]propoxy)-propan-1-ol and 2-(1-Methyl-2-(1,7,7-trimethylbicyclo[2.2.1]hept-2-yloxy)ethoxy)propan-1-ol",958872-63-4,"Acute oral toxicity: OECD guideline 423 and EU method B.1. GLP.Acute dermal toxicity: OECD guideline 402 and EU method B.3. GLP.Acute inhalation toxicity: because of its low vapour pressure, exposure by inhalation need not to be considered. In accordance with section 2 of REACH annex XI, Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f21fcdfc-473e-4ca0-a0b8-7f8dcaea80bd/documents/IUC5-b33ef1c7-c807-47a8-b4f7-9f93c193d5b9_c9981a7b-d7a0-4414-b20f-89d1c5593c9c.html,,,,,, 2-[(2-hydroxypropyl)(C16-18 sat. C18 unsat. alkyl)amino]propan-1-ol,1309955-79-0,"There is a 90-day subchronic repeat-dose study on di-(2-hydroxypropyl) C16-C18 (evennumbered), C18 unsaturated-alkyl amine CAS 1309955-79-0 in rats available. This 90-day study was a combination study with a OECD TG 422 study which resulted in a 10 week premating period follwed by maternal female rats being dosed several weeks longer through pregnancy and lactation. Dosing of the test substance occured at 50, 150 and 300 mg/kg bw/day. This study adheared to both the OECD 408 and 422 testing guidelines with only minor deviations.   There are two addtional 90-day oral toxicity studies for the analouge substance Ethanol, 2,2’-iminobis-, N-tallow alkyl derives CAS No 61791-44-4 registered under 2,2’-(C16-18 (even numbered, C18 unsaturated) alkyl imino) diethanol CAS No 1218787-32-6.  There is a 90 day dietary study in rats and a 90 Day study in dogs where the test substance was added to the diet in a solution in maize oil.  The Dog study was dosed at 13, 40, 120 mg/kg/day with a maize oil vehicle control.  The rats were feed diets containing 170, 500, 1’500 and 4’500ppm of the tests substance.  Both studies provide NOAEL values.  These studies were carried out in 1965, but are sufficiently well documented including information on the test substance to be considered suitable for use for REACH. Due to issues with sporadic vomiting and anorexia in the dog study, the data from the rat study is considered more reliable.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The test used for establishing NOAELs for repeat exposure was performed with a valid test sample of Propanol, iminobis-, N-C16-C18 (evennumbered), C18 unsatd. alkyl) derivs. that was within specifications and under appropriate OECD guidlines. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6607ea73-4d89-4192-8a38-f883820842f3/documents/IUC5-6129258e-e22f-48a0-ab49-def036e4f0d4_a4d24141-141a-47c9-a60c-64c558b5227f.html,,,,,, 2-[(2-hydroxypropyl)(C16-18 sat. C18 unsat. alkyl)amino]propan-1-ol,1309955-79-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6607ea73-4d89-4192-8a38-f883820842f3/documents/IUC5-6129258e-e22f-48a0-ab49-def036e4f0d4_a4d24141-141a-47c9-a60c-64c558b5227f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat 2-[(2-hydroxypropyl)(C16-18 sat. C18 unsat. alkyl)amino]propan-1-ol,1309955-79-0,"No acute oral toxicity studies are available for the substance but for the read across source substance there is an acute oral toxicity study, of which is validity 1, with addtional supportive data.  In the study considered most relevant to the classification of this substnace the LD50 values (plus 95% confidence limits) were LD50 of 1260 (1053 - 1508) mg/kg body weight. Based on a mean vlaue 1260mg/kg will be used for classification etc. LD50 = 1260 mg/kg bw. The only study available is an oral LD50 study on 2,2'-(Octadec-9-enylimino)bisethanol  CAS No 25307-17-9, the study is reliability 1 GLP compliant to OECD Guideline 401. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Sufficient. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6607ea73-4d89-4192-8a38-f883820842f3/documents/IUC5-f4661e38-1fb8-456b-8da7-4431c2376c28_a4d24141-141a-47c9-a60c-64c558b5227f.html,,,,,, 2-[(2-hydroxypropyl)(C16-18 sat. C18 unsat. alkyl)amino]propan-1-ol,1309955-79-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6607ea73-4d89-4192-8a38-f883820842f3/documents/IUC5-f4661e38-1fb8-456b-8da7-4431c2376c28_a4d24141-141a-47c9-a60c-64c558b5227f.html,,oral,LD50,"1,260 mg/kg bw",adverse effect observed, Propene,115-07-1,"The weight of evidence indicates that the effects in rodents, which unlike man are obligate nasal breathers, superimposed on a high background of spontaneous nasal pathology and with equivocal dose responses, are likely to be of little relevance in extrapolation of risk to humans and considered an inappropriate finding from which to derive a DNEL. In addition, the concentrations at which the mild rhinitis was reported in lifetime animal experiments are very high compared to the concentrations that humans may be exposed to in practice. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db1ad667-b769-4585-a6a1-4e486af7839e/documents/IUC5-3fea9ab0-4405-4dc0-ac42-86973d159a88_40c72a94-a9d7-49bb-afb1-36fbdfa411b7.html,,,,,, Propene,115-07-1,"Across species, there are no adverse effects reported of acute inhalational exposure of propene, below concentrations of about 40% (688,000 mg/m3), when anaesthesia occurs. As the lower flammability limit for propene is 2% (34,400 mg/m3), the explosive range of airborne concentrations for propene is reached long before acute toxicity may be manifested. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db1ad667-b769-4585-a6a1-4e486af7839e/documents/IUC5-9edf7974-22ce-48a2-aafb-b2d41c55eeb8_40c72a94-a9d7-49bb-afb1-36fbdfa411b7.html,,,,,, Propionamide,79-05-0,"Based on the results of the combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the parental NOAEL for the test item was established to be 120 mg/kg bw/day (reference 7.5.1-1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study is considered of sufficient quality as it was conducted in accordance with generally accepted scientific standards under GLP. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f88312d7-f392-4d99-bb49-fd231963f92e/documents/2cce7838-cce4-4d69-833b-1ad50459b176_bd36f599-9bd6-4251-bf7c-d24273fbcccc.html,,,,,, Propionamide,79-05-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f88312d7-f392-4d99-bb49-fd231963f92e/documents/2cce7838-cce4-4d69-833b-1ad50459b176_bd36f599-9bd6-4251-bf7c-d24273fbcccc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat Propionamide,79-05-0,"In a study according to OECD guideline 423, a LD50 higher than 2000 mg/kg bw was determined for the test item after single oral administration in female rats (reference 7.2.1-1). In a study according to OECD guideline 402, the acute dermal LD50 of the test item was determined to be greater than 2000 mg/kg bw in rats (reference 7.2.3-1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The quality of the experimental study is sufficient as it was conducted according to guideline and under GLP. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The quality of the experimental study is sufficient as it was conducted according to guideline and under GLP. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f88312d7-f392-4d99-bb49-fd231963f92e/documents/7e60f05f-fec9-416d-87aa-9533eac28a99_bd36f599-9bd6-4251-bf7c-d24273fbcccc.html,,,,,, Propionamide,79-05-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f88312d7-f392-4d99-bb49-fd231963f92e/documents/7e60f05f-fec9-416d-87aa-9533eac28a99_bd36f599-9bd6-4251-bf7c-d24273fbcccc.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Propionamide,79-05-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f88312d7-f392-4d99-bb49-fd231963f92e/documents/7e60f05f-fec9-416d-87aa-9533eac28a99_bd36f599-9bd6-4251-bf7c-d24273fbcccc.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Propionic anhydride,123-62-6,"OralSub chronic repeated dose toxicityNOAEL (90d, rat) = 6200 ppm (approx 620 mg/kg bw)Chronic repeated dose toxicityLOAEL (local toxicity, rats, life time study): 400 ppm (264 mg/kg bw) NOAEL (systemic toxicity, rats, life time study): 4000 ppm(2640 mg/kg bw) DermalLOAEL (90 d, mouse, local effects) = 136.9 mg/kg bw ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1937ab3b-0f83-4197-8381-5de94257287d/documents/IUC5-b682ce08-5c26-457b-8f64-ecd87bd29a51_9bd2e2c5-e697-451f-8d27-c4c41b16a411.html,,,,,, Propionic anhydride,123-62-6,Acute oral toxicity- LD50 (male and female: rat): 3455.1 mg/kg bw (2978.9-4007.5) (BASF AG 1969)Acute inhalation toxicity:LC50 is supposed to be > 20 mg/L /4h (vapor) based onthe available information (BASF 1969; Smyth et al. 1962) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1937ab3b-0f83-4197-8381-5de94257287d/documents/IUC5-71baf44f-c26f-475d-acce-59a7cc37bc67_9bd2e2c5-e697-451f-8d27-c4c41b16a411.html,,,,,, Propionic anhydride,123-62-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1937ab3b-0f83-4197-8381-5de94257287d/documents/IUC5-71baf44f-c26f-475d-acce-59a7cc37bc67_9bd2e2c5-e697-451f-8d27-c4c41b16a411.html,,oral,LD50,"3,455 mg/kg bw",, Propionic anhydride,123-62-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1937ab3b-0f83-4197-8381-5de94257287d/documents/IUC5-71baf44f-c26f-475d-acce-59a7cc37bc67_9bd2e2c5-e697-451f-8d27-c4c41b16a411.html,,inhalation,LC50,"19,700 mg/m3",, Propiononitrile,107-12-0, A large amount of studies is available on the acute toxicity of propionitrile. The most relevant available studies for classification have been added as indiviudal entries. An overview of all acute toxicity studies is given in the literature list attached in section 13. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1252c76b-b8f9-408a-af43-0184cb74e883/documents/a251b71b-1bef-407c-999b-4aab0431219e_7d3bca4f-a996-4b0f-a5cb-f317ebc7d411.html,,,,,, Propionyl chloride,79-03-8,Acute oral toxicity data indicate a moderate toxicity: in rats the oral LD50 was 823 mg/kg bw. In the acute inhalation toxicity study a LC50 value of >0.2 mg/L was determined. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22af5066-6deb-4ca7-ac18-2d411f897fa2/documents/IUC5-0e42ad52-1fc4-44dc-bd96-aebe47606e4d_cd9efb8d-393c-4ca1-b547-94aff9362521.html,,,,,, Propiophenone,93-55-0," Oral NOAEL (28d) rat, males and females, systemic toxicity: 75 mg/kg bw/day Oral NOAEL (28d) rat, males and females, neurological effects: 225 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/943e2aed-118b-439a-ae53-a00d21938b1b/documents/444eb495-791c-4360-8bca-396fcb5abf11_78bbea68-22a4-4a4c-8f81-3b5a0b092991.html,,,,,, Propiophenone,93-55-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/943e2aed-118b-439a-ae53-a00d21938b1b/documents/444eb495-791c-4360-8bca-396fcb5abf11_78bbea68-22a4-4a4c-8f81-3b5a0b092991.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat Propiophenone,93-55-0,Rat LD50 oral: 4490 mg/kgDermal LD50 rabbit: 4490 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/943e2aed-118b-439a-ae53-a00d21938b1b/documents/c742d2e8-8634-4542-bda1-cc2919d3e0f5_78bbea68-22a4-4a4c-8f81-3b5a0b092991.html,,,,,, Propiophenone,93-55-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/943e2aed-118b-439a-ae53-a00d21938b1b/documents/c742d2e8-8634-4542-bda1-cc2919d3e0f5_78bbea68-22a4-4a4c-8f81-3b5a0b092991.html,,oral,LD50,"4,490 mg/kg bw",no adverse effect observed, Propiophenone,93-55-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/943e2aed-118b-439a-ae53-a00d21938b1b/documents/c742d2e8-8634-4542-bda1-cc2919d3e0f5_78bbea68-22a4-4a4c-8f81-3b5a0b092991.html,,dermal,LD50,"4,490 mg/kg bw",no adverse effect observed, propyl (2S)-2-[(2-methylbutan-2-yl)oxy]propanoate,319002-92-1,"Repeated dose toxicity oral: NOAEL = 1000 mg/kg bw/d (OECD 407, GLP, K, rel. 1) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6482c7b6-b5cb-4857-bcd3-0f97e02bdb53/documents/IUC5-7c4b7524-839d-453a-a286-42158f8c3aaf_f27f2e37-5ae6-4edf-b274-b9e2843e060e.html,,,,,, propyl (2S)-2-[(2-methylbutan-2-yl)oxy]propanoate,319002-92-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6482c7b6-b5cb-4857-bcd3-0f97e02bdb53/documents/IUC5-7c4b7524-839d-453a-a286-42158f8c3aaf_f27f2e37-5ae6-4edf-b274-b9e2843e060e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat propyl (2S)-2-[(2-methylbutan-2-yl)oxy]propanoate,319002-92-1,"Acute toxicity: oral: LD50combined > 5000 mg/kg bw (OECD 423, GLP, K, rel. 1)Acute toxicity: dermal: LD50combined > 2000 mg/kg bw (OECD 402, GLP, K, rel. 1)Acute toxicity: inhalation: no data ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6482c7b6-b5cb-4857-bcd3-0f97e02bdb53/documents/IUC5-46efa827-dae2-405b-a7fc-fb5008bd1860_f27f2e37-5ae6-4edf-b274-b9e2843e060e.html,,,,,, propyl (2S)-2-[(2-methylbutan-2-yl)oxy]propanoate,319002-92-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6482c7b6-b5cb-4857-bcd3-0f97e02bdb53/documents/IUC5-46efa827-dae2-405b-a7fc-fb5008bd1860_f27f2e37-5ae6-4edf-b274-b9e2843e060e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, propyl (2S)-2-[(2-methylbutan-2-yl)oxy]propanoate,319002-92-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6482c7b6-b5cb-4857-bcd3-0f97e02bdb53/documents/IUC5-46efa827-dae2-405b-a7fc-fb5008bd1860_f27f2e37-5ae6-4edf-b274-b9e2843e060e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Propyl chloroformate,109-61-5, The 28-day NOAEC for the OECD SIDS category member isopropyl chloroformate was 21 mg/m3/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4d58048-32f5-4cf3-a55f-fbfe96b68361/documents/ec66897a-d1a6-4837-b955-b1347f5c03d8_9b8a003c-2e7c-449a-a7b1-12567df68e87.html,,,,,, Propyl chloroformate,109-61-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c4d58048-32f5-4cf3-a55f-fbfe96b68361/documents/ec66897a-d1a6-4837-b955-b1347f5c03d8_9b8a003c-2e7c-449a-a7b1-12567df68e87.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,21 mg/m3,,rat Propyl chloroformate,109-61-5,oral LD50: 1000 - 1470 mg/kg (rat) inhalative LC50: 1.6 mg/L/1h (rat) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c4d58048-32f5-4cf3-a55f-fbfe96b68361/documents/942434e0-675b-46ea-8345-a247cb16e71f_9b8a003c-2e7c-449a-a7b1-12567df68e87.html,,,,,, Propyl oleate,111-59-1," In conclusion, the data generated in this study show that consumption of ethyl oleate in the diet of rats at up to 10% of the diet for 91 days (consumption generally ranged between 4 and 8 g ethyl oleate/kg body weight/day) was well-tolerated and devoid of any toxic effects. Based on the conclusion of the 91 d feeding study in rats the LD50 after single oral application in rats of ethyl oleate (source substance) and propyl oleate (target substance) is > 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8c40c36-c39c-4cf0-867d-4bdc38973582/documents/de2e2b4a-0803-423b-904b-0c50562b3ff9_5c358d63-59f2-42f6-8bb4-54adde61b3d2.html,,,,,, Propyl oleate,111-59-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a8c40c36-c39c-4cf0-867d-4bdc38973582/documents/de2e2b4a-0803-423b-904b-0c50562b3ff9_5c358d63-59f2-42f6-8bb4-54adde61b3d2.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Propylidynetrimethanol, ethoxylated",50586-59-9,"NOAEL (28 days repeated dose, Wistar): 1000 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/61498b2c-0ffe-462a-953a-8d46bf987219/documents/92de5fbe-2ad4-44a8-8fd0-07e92b0fa304_3212b5f2-d720-4aa2-ade1-58e2dddc029d.html,,,,,, "Propylidynetrimethanol, ethoxylated",50586-59-9,The acute oral median lethal dose (LD50) of the test material in the female rat was greater than 2000 mg/kg body weight and greater than 5000 mg/kg body weight in male anf female rats. The acute dermal median lethal dose (LD50) of the test material in rats was found to be greater than 2000 mg/kg bodyweight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61498b2c-0ffe-462a-953a-8d46bf987219/documents/c174b0bc-3b2a-4f78-a7f1-4b5deb4c247b_3212b5f2-d720-4aa2-ade1-58e2dddc029d.html,,,,,, "Propylidynetrimethanol, ethoxylated, esters with acrylic acid, reaction products with diethylamine",159034-91-0,"In a 90-day repeated toxicity study, groups of male and females rats received the test-item by oral route at dose levels of 250, 500 and 1000 mg/kg/d. Under the conditions of the study, the NOAEL (No Observed Adverse Effect Level) was considered to be 250 mg/kg/day for both sexes, based on clinical signs and mortalities. Clinical signs consisted mainly of salivation and respiratory difficulties with a high prevalence in animals (males and females) treated at ≥ 500 mg/kg/day. These observations were considered secondary to accidental reflux/aspiration of the formulation into the respiratory tract.The test item was administered daily for 4 weeks by oral route to male and female Sprague-Dawley rats at dose-levels of 100, 300 or 1000 mg/kg/day in corn oil. Under the experimental conditions of this study, the No Observed Adverse Effect Level (NOAEL) was considered to be at 300 mg/kg/day based on the adverse clinical signs observed at 1000 mg/kg/day. Clinical signs consisted of ptyalism, breathing difficulties, thin appearance and hunched posture. Half of the 1000 mg/kg/day animals had hunched posture, dyspnea, piloerection and/or hypoactivity at FOB. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/538e45b4-75d3-44fc-88cb-4f136c52e02c/documents/IUC5-6c5da28c-595e-4101-a92d-4bee7108783a_b8dd3f05-6fc4-4923-934a-c5dd6c012d1b.html,,,,,, "Propylidynetrimethanol, ethoxylated, esters with acrylic acid, reaction products with diethylamine",159034-91-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/538e45b4-75d3-44fc-88cb-4f136c52e02c/documents/IUC5-6c5da28c-595e-4101-a92d-4bee7108783a_b8dd3f05-6fc4-4923-934a-c5dd6c012d1b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Propylidynetrimethanol, ethoxylated, esters with acrylic acid, reaction products with diethylamine",159034-91-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/538e45b4-75d3-44fc-88cb-4f136c52e02c/documents/IUC5-6c5da28c-595e-4101-a92d-4bee7108783a_b8dd3f05-6fc4-4923-934a-c5dd6c012d1b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Propylidynetrimethanol, ethoxylated, esters with acrylic acid, reaction products with diethylamine",159034-91-0,"The potential of acute toxicity of Diethylamine modified ethoxylated trimethylolpropane triacrylate was evaluated in two studies, one by oral route and one by dermal route. No mortalities were showed in both studies; the oral and dermal LD50 were higher than 2000 mg/kg in rats. No data is available by inhalation. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/538e45b4-75d3-44fc-88cb-4f136c52e02c/documents/IUC5-3388a826-e62d-4f26-9000-c214189dc6ce_b8dd3f05-6fc4-4923-934a-c5dd6c012d1b.html,,,,,, "Propylidynetrimethanol, ethoxylated, esters with acrylic acid, reaction products with diethylamine",159034-91-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/538e45b4-75d3-44fc-88cb-4f136c52e02c/documents/IUC5-3388a826-e62d-4f26-9000-c214189dc6ce_b8dd3f05-6fc4-4923-934a-c5dd6c012d1b.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Propylidynetrimethanol, ethoxylated, esters with acrylic acid, reaction products with diethylamine",159034-91-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/538e45b4-75d3-44fc-88cb-4f136c52e02c/documents/IUC5-3388a826-e62d-4f26-9000-c214189dc6ce_b8dd3f05-6fc4-4923-934a-c5dd6c012d1b.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Propylidynetrimethanol, propoxylated",25723-16-4," Subchronic (90-day) oral repeated dose toxicity (OECD 408): NOAEL (rat, m/f) = 300 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb4d2f62-66e3-490b-be7b-27e0ce5ff148/documents/b5a553cd-2de7-4d5a-9619-27452912bb67_c0e59563-3e26-45be-b840-2403db984042.html,,,,,, "Propylidynetrimethanol, propoxylated",25723-16-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb4d2f62-66e3-490b-be7b-27e0ce5ff148/documents/b5a553cd-2de7-4d5a-9619-27452912bb67_c0e59563-3e26-45be-b840-2403db984042.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Propylidynetrimethanol, propoxylated",25723-16-4," Acute oral toxicity (OECD 423): LD50 (rat, f) > 2000 mg/kg bw Acute dermal toxicity (OECD 402): LD50 (rat, m/f) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb4d2f62-66e3-490b-be7b-27e0ce5ff148/documents/701dc4b6-91a7-43c5-bc82-4ac0d19cdb3c_c0e59563-3e26-45be-b840-2403db984042.html,,,,,, Propyloxirane,1003-14-1,"LD50 oral = 1460 mg/kg bw (BASF AG, 1982, OECD401)LC50 inhalation >10.6 and < 21.3 mg/l (BASF AG, 1990, OECD403)LD50 dermal >1500 and < 2950 mg/kg bw (Smyth et al, 1962) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f57e1e32-baf3-4f19-9180-b9fb4f474fc7/documents/IUC5-86b064fd-d084-4605-8d6b-27e8c34ea05a_e31e40b0-c217-4120-99bf-a8d58036dbc5.html,,,,,, Propyloxirane,1003-14-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f57e1e32-baf3-4f19-9180-b9fb4f474fc7/documents/IUC5-86b064fd-d084-4605-8d6b-27e8c34ea05a_e31e40b0-c217-4120-99bf-a8d58036dbc5.html,,oral,LD50,"1,460 mg/kg bw",, Propyltriacetoxysilane,17865-07-5,"Weight of evidence: Based on experimental results obtained in repeated dose toxicity studies with supporting substances acetic acid and sodium acetate, read-across approach was applied and the NOAEL (28 days in rats) for propyltriacetoxysilane was calculated to be greater than 3632.48 mg/kg bw/day (based on no effects observed at the highest dose). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/938965c1-0588-4218-b027-25c23a4c5b46/documents/IUC5-f4743c5e-76a5-4deb-b6d6-3557597463f7_4edc9cd8-27f7-4a86-a7fd-a4e67cf02003.html,,,,,, Propyltriacetoxysilane,17865-07-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/938965c1-0588-4218-b027-25c23a4c5b46/documents/IUC5-f4743c5e-76a5-4deb-b6d6-3557597463f7_4edc9cd8-27f7-4a86-a7fd-a4e67cf02003.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"3,632.48 mg/kg bw/day",,rat Propyltriacetoxysilane,17865-07-5,"Acute toxicity (oral): Data waiving (other justification): In accordance with column 2 of REACH Annex VIII, the study does not to be conducted since the substance is classified as corrosive to the skin.Acute toxicity (inhalation): Data waiving (other justification): In accordance with column 2 of REACH Annex VIII, the study does not to be conducted since the substance is classified as corrosive to the skin.Acute toxicity (dermal): Data waiving (other justification): In accordance with column 2 of REACH Annex VIII, the study does not to be conducted since the substance is classified as corrosive to the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/938965c1-0588-4218-b027-25c23a4c5b46/documents/IUC5-6d735d03-8407-4f41-a7e5-414905801246_4edc9cd8-27f7-4a86-a7fd-a4e67cf02003.html,,,,,, "Protein hydrolyzates, animal",100085-61-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f344e6d-f567-4207-8124-3db2dbf4ad1d/documents/IUC5-bfad36fc-12cb-474c-8a38-9ca46ae5d4c7_c8817d2d-ad7b-4593-8afb-7201ee25b84b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Protein hydrolyzates, animal",100085-61-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f344e6d-f567-4207-8124-3db2dbf4ad1d/documents/966202aa-b306-469e-8e1f-d24dd457f976_c8817d2d-ad7b-4593-8afb-7201ee25b84b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Proteinase, Aspergillus acid",9025-49-4, Acute toxicity via the oral route has been tested. No signs of toxicity were observed at the highest dose toxicity of 2000 total protein mg/kg bw. The test was conducted according to OECD guidelines and GLP standards. Acute toxicity via the inhalation and dermal route is waived based on exposure considerations and the known properties of the substance. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be301ed9-40dc-4f85-8cb4-e2ea2429ef0c/documents/2cba2b5b-6b12-4a3e-aa58-de418bb23cfe_8cbc5476-c41c-4786-8beb-fd458081a821.html,,,,,, "Proteinase, Aspergillus acid",9025-49-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be301ed9-40dc-4f85-8cb4-e2ea2429ef0c/documents/2cba2b5b-6b12-4a3e-aa58-de418bb23cfe_8cbc5476-c41c-4786-8beb-fd458081a821.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Proteinase, Bacillus subtilis metallo-",9080-56-2," The oral administration of bacillolysin batch PPA 30428 to Crl:CD(SD) rats at doses up to 10 mL/kg/day for 13-weeks was well tolerated and did not result in any toxicologically significant change. Consequently, the no observed adverse effect level (NOAEL) in this study was considered to be 10 mL/kg/day (equivalent to 0.993 g TOS/kg/day). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8a9d30a-c87b-4bce-aea6-9574f902adea/documents/9d49acdc-eb00-4e0d-af1f-f4bad9f1282a_61d07c80-682a-4299-989c-754b1bb06e91.html,,,,,, "Proteinase, Bacillus subtilis metallo-",9080-56-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8a9d30a-c87b-4bce-aea6-9574f902adea/documents/9d49acdc-eb00-4e0d-af1f-f4bad9f1282a_61d07c80-682a-4299-989c-754b1bb06e91.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,993 mg/kg bw/day,,rat "Proteinase, Bacillus subtilis metallo-",9080-56-2," The acute toxicity of bacillolysin has not been tested, however, a 13-week oral toxicity study is available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8a9d30a-c87b-4bce-aea6-9574f902adea/documents/7f09bc5f-f543-45f0-ad53-bfc6d4cbba0a_61d07c80-682a-4299-989c-754b1bb06e91.html,,,,,, Prussian blue,14038-43-8," Repeated dose toxicity: Oral Repeated dose oral toxicity study was performed to determine the toxic nature of Prussian blue. The test chemical was mixed with feed and was tested at dose levels of 0 or 500 mg/Kg/day for 120 days. The test chemical was given by the oral (feed) route of exposure. During the study period, Berlin blue caused a slight increase in the weight gain of treated rats but it did not show any statistical significance (P: 0.2). Based on these considerations, the No observed adverse effect level (NOAEL) for Berlin blue is considered to be 500 mg/Kg/day. Repeated dose toxicity: Inhalation The melting point C.I.Pigment Blue 27 is >300 C. This suggests that Prussian violet insoluble decomposes between 210°C -360 °C without melting and does not exhibit very high vapour pressure. Inhalation is therefore not the likely route of exposure and hence this end point for repeated dose toxicity be inhalation route is considered for waiver. Repeated dose toxicity: Dermal The Prussian blue insoluble (14038-43-8) has high molecular weight i.e 877.381 g/mol. This suggests that Prussian violet insoluble has no potential for significant rate of absorption through the skin and hence this end point for repeated dose toxicity dermal is considered for waiver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a091f0f-3e7a-4e0c-8d25-ef4c17285516/documents/6fc86bb8-8b37-450a-808d-e42bbbdc4e2b_52ecda15-a208-41ef-90e7-0aa0733dfdcf.html,,,,,, Prussian blue,14038-43-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a091f0f-3e7a-4e0c-8d25-ef4c17285516/documents/6fc86bb8-8b37-450a-808d-e42bbbdc4e2b_52ecda15-a208-41ef-90e7-0aa0733dfdcf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Prussian blue,14038-43-8," Acute Oral Toxicity:  In Acute oral toxicity, LD50 value for target substance Prussian blue(14068-43-8) was considered to be >8000 mg/kg bw for rats ; >8000 mg/kg bw for mouse and >8000 mg/kg bw for rabbits. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Prussian blue(14068-43-8) cannot be classified for acute oral toxicity. Acute Inhalation Toxicity:  The melting point of C.I.Pigment Blue 27 is >300 C. This suggests that Prussian blue insoluble decomposes between 210°C -360 °C without melting and does not exhibit very high vapour pressure. Inhalation is therefore not likely route of exposure and hence this end point is considered for waiver. Acute Dermal Toxicity: The Prussian blue insoluble (14038-43-8) has high molecular weight i.e 877.381g/mole. This suggests that Prussian blue insoluble has no potential for significant rate of absorption through skin and hence this end point is considered for waiver. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a091f0f-3e7a-4e0c-8d25-ef4c17285516/documents/4c057c00-5469-4df1-af70-882d6ec64fc2_52ecda15-a208-41ef-90e7-0aa0733dfdcf.html,,,,,, Prussian blue,14038-43-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a091f0f-3e7a-4e0c-8d25-ef4c17285516/documents/4c057c00-5469-4df1-af70-882d6ec64fc2_52ecda15-a208-41ef-90e7-0aa0733dfdcf.html,,oral,LD50,"8,000 mg/kg bw",no adverse effect observed, Pseudoephedrine hydrochloride,345-78-8,"In an acute oral toxicity study (OECD 401), the LD50 was determined to be ca. 1000 and 464 mg/kg bw for male and female rats, respectively. In an acute inhalation toxicity study (OECD 403), the LC50 was determined to be >2 mg/L. In an acute dermal toxicity study (OECD 402), the LD50 was determined to be >2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/709a03e8-4b6b-4621-b4a2-d5ccda2e9128/documents/IUC5-bd7accbb-d14d-4780-af74-22c1dd311558_82a4de13-31b9-4822-8580-96ab0559fa62.html,,,,,, Pseudoephedrine hydrochloride,345-78-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/709a03e8-4b6b-4621-b4a2-d5ccda2e9128/documents/IUC5-bd7accbb-d14d-4780-af74-22c1dd311558_82a4de13-31b9-4822-8580-96ab0559fa62.html,,oral,LD50,464 mg/kg bw,adverse effect observed, p-tert-butylcinnamaldehyde,84434-23-1,The acute oral toxicity of the test material in rats was determined to be 2.6 mL/kg bw (95 % CI 2.43-2.9) (equivalent to approximately 2770 mg/kg bw when assuming a relative density of 0.96) in a study performed to a method similar to OECD 401. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e791283-49af-4953-b70f-0f61832b4073/documents/IUC5-62d8ce7c-eded-41f8-9a14-4b67a52bc2b4_f04c924c-b075-498a-a07a-38b890b380de.html,,,,,, "p-tert-butylphenyl 1-(2,3-epoxy)propyl ether",3101-60-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e223e0c-b232-4397-87d5-5fb075756d8d/documents/IUC5-c3d2120f-bc04-4bf1-a8a9-d2cf518412cd_bb3b08c0-5e5b-4ea5-9586-d828bf790065.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "p-tert-butylphenyl 1-(2,3-epoxy)propyl ether",3101-60-8,"The test substance, p-tert-butylphenyl-1-(2,3)-epoxypropyl ether was accessed for both acute oral and dermal toxicity in the rat by O.E.C.D. test guideline studies. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e223e0c-b232-4397-87d5-5fb075756d8d/documents/IUC5-0523db16-40f2-481a-a385-f765d5039e2d_bb3b08c0-5e5b-4ea5-9586-d828bf790065.html,,,,,, p-tert-butylstyrene,1746-23-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0868852d-4611-488f-b872-288fbd338552/documents/f3e615ce-f8cd-45c1-b616-082424646b09_c61fdf04-dcde-4868-a8c4-d2b7b3c83d3f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat p-tert-butylstyrene,1746-23-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0868852d-4611-488f-b872-288fbd338552/documents/dd966474-5a28-47c4-beae-f5df15063656_c61fdf04-dcde-4868-a8c4-d2b7b3c83d3f.html,,oral,LD50,"3,375 mg/kg bw",adverse effect observed, p-tert-butylstyrene,1746-23-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0868852d-4611-488f-b872-288fbd338552/documents/dd966474-5a28-47c4-beae-f5df15063656_c61fdf04-dcde-4868-a8c4-d2b7b3c83d3f.html,,dermal,LD50,"4,585 mg/kg bw",no adverse effect observed, p-tert-butylstyrene,1746-23-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0868852d-4611-488f-b872-288fbd338552/documents/dd966474-5a28-47c4-beae-f5df15063656_c61fdf04-dcde-4868-a8c4-d2b7b3c83d3f.html,,inhalation,LC50,"16,891 mg/m3",adverse effect observed, p-toluenesulphonyl isocyanate,4083-64-1,90-day oral toxicity in rats: NOAEL 231 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e74c9c81-df24-4e0e-93ec-ee29c2ae49aa/documents/IUC5-7c86b54b-f6b4-49f5-9fd6-87ef33d089be_41d264dc-7457-41f9-85ca-9266e1524059.html,,,,,, p-toluenesulphonyl isocyanate,4083-64-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e74c9c81-df24-4e0e-93ec-ee29c2ae49aa/documents/IUC5-7c86b54b-f6b4-49f5-9fd6-87ef33d089be_41d264dc-7457-41f9-85ca-9266e1524059.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,231 mg/kg bw/day,,rat p-toluenesulphonyl isocyanate,4083-64-1,Acute oral toxicity (males and female rats): LD50 = 2330 mg/kg bwAcute dermal toxicity (male and female rats): LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e74c9c81-df24-4e0e-93ec-ee29c2ae49aa/documents/IUC5-93474225-87ce-4ac1-804e-fe1bbd365735_41d264dc-7457-41f9-85ca-9266e1524059.html,,,,,, p-toluenesulphonyl isocyanate,4083-64-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e74c9c81-df24-4e0e-93ec-ee29c2ae49aa/documents/IUC5-93474225-87ce-4ac1-804e-fe1bbd365735_41d264dc-7457-41f9-85ca-9266e1524059.html,,oral,LD50,"2,330 mg/kg bw",adverse effect observed, p-toluenesulphonyl isocyanate,4083-64-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e74c9c81-df24-4e0e-93ec-ee29c2ae49aa/documents/IUC5-93474225-87ce-4ac1-804e-fe1bbd365735_41d264dc-7457-41f9-85ca-9266e1524059.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, p-toluic acid,99-94-5, Under the conditions of this 28 day repeat dose study it was determined NOEL 300 mg/kg bw; NOAEL (male) >1000 mg/kg bw. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18af81f8-44cc-4eb1-a75f-4486ab0fe18d/documents/ec87bae2-27fd-426a-9bdd-d6c59c940128_4257dfcd-bf0a-48fa-ac24-7400c7898eb7.html,,,,,, p-toluic acid,99-94-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18af81f8-44cc-4eb1-a75f-4486ab0fe18d/documents/ec87bae2-27fd-426a-9bdd-d6c59c940128_4257dfcd-bf0a-48fa-ac24-7400c7898eb7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat p-toluic acid,99-94-5," Although the intraperitoneal injection studies in the rat returned results of LD50 male 944 mg/kg bw and female 874 mg/kg bw, which implies a classification of Acute Toxicity 4, they will not be used for classifcation as this is not an accepted route for human exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18af81f8-44cc-4eb1-a75f-4486ab0fe18d/documents/65ed8c3f-7aee-4a08-8f65-13d3a7955597_4257dfcd-bf0a-48fa-ac24-7400c7898eb7.html,,,,,, p-toluic acid,99-94-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18af81f8-44cc-4eb1-a75f-4486ab0fe18d/documents/65ed8c3f-7aee-4a08-8f65-13d3a7955597_4257dfcd-bf0a-48fa-ac24-7400c7898eb7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, p-tolyl isocyanate,622-58-2,No repeated dose studies for p-tolyl isocyanate are available. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/d67b586a-086c-4d97-8367-54992a67d3fa/documents/IUC5-17fa3bb1-5e77-41da-8bfd-0f3f429d6838_4d1cb8d7-8fbb-4737-87d7-9f79c40e9bc7.html,,,,,, p-tolyl isocyanate,622-58-2,"Only acute toxicity studies from a secondary source (oral, inhalation, other routes) for p-tolylisocyanate are available. In the acute oral toxicity study a LD50 of ca. 1600 to 3200 mg/kg bw was found. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d67b586a-086c-4d97-8367-54992a67d3fa/documents/IUC5-48209a45-0a0f-4e66-ba91-9842f26a3aa3_4d1cb8d7-8fbb-4737-87d7-9f79c40e9bc7.html,,,,,, p-tolyl isocyanate,622-58-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d67b586a-086c-4d97-8367-54992a67d3fa/documents/IUC5-48209a45-0a0f-4e66-ba91-9842f26a3aa3_4d1cb8d7-8fbb-4737-87d7-9f79c40e9bc7.html,,oral,LD50,"1,600 mg/kg bw",, p-tolyl isocyanate,622-58-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d67b586a-086c-4d97-8367-54992a67d3fa/documents/IUC5-48209a45-0a0f-4e66-ba91-9842f26a3aa3_4d1cb8d7-8fbb-4737-87d7-9f79c40e9bc7.html,,inhalation,LC50,33 mg/m3,, Pullulanase,9075-68-7," The repeated dose oral toxicity of pullulanase has been tested. The repeated dose inhalation and dermal toxicity were waived based on exposure considerations and the properties of the substance. The repeated dose oral toxicity was a subchronic toxicity test conducted according to OECD guideline 408 , and in compliance with GLP. The conclusion was that the No Observed Adverse Effect Level (NOAEL) in rats was the highest dose level tested - 851 mg/kg bw/day based on TOS (total organic solids). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e3ebafe-f756-4062-b6aa-21be645eef4e/documents/IUC5-60c09e86-9701-4688-bdf5-0af542af86f1_d4377e2a-b8a4-4c9b-8ba0-8daa53c91129.html,,,,,, Pullulanase,9075-68-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e3ebafe-f756-4062-b6aa-21be645eef4e/documents/IUC5-60c09e86-9701-4688-bdf5-0af542af86f1_d4377e2a-b8a4-4c9b-8ba0-8daa53c91129.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,851 mg/kg bw/day,,rat Pullulanase,9075-68-7," The acute oral and inhalation toxicity of pullulanase has been tested. The acute oral toxicity test and the acute inhalation toxicity test were short-term toxicity tests conducted according to OECD guidelines, and in compliance with GLP. No acute dermal toxicity test was conducted. The conclusion was that pullulanase is non-toxic by acute oral and inhalation exposure (GHS Toxicity category V). Based on weight of evidence, pullulanase does not exert any acute dermal toxicity under foreseeable realistic exposures for both workers and consumers. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e3ebafe-f756-4062-b6aa-21be645eef4e/documents/IUC5-b5d4603a-f19d-4494-998b-49cb5e5b1a90_d4377e2a-b8a4-4c9b-8ba0-8daa53c91129.html,,,,,, Pullulanase,9075-68-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e3ebafe-f756-4062-b6aa-21be645eef4e/documents/IUC5-b5d4603a-f19d-4494-998b-49cb5e5b1a90_d4377e2a-b8a4-4c9b-8ba0-8daa53c91129.html,,oral,LD50,"2,012 mg/kg bw",no adverse effect observed, Pullulanase,9075-68-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e3ebafe-f756-4062-b6aa-21be645eef4e/documents/IUC5-b5d4603a-f19d-4494-998b-49cb5e5b1a90_d4377e2a-b8a4-4c9b-8ba0-8daa53c91129.html,,inhalation,LC50,"2,140 mg/m3",no adverse effect observed, p-xylene,106-42-3,"In repeated dose studies, the principle effects of xylenes were adaptive changes in the liver, organ weight and body weight changes. Inhalation studies in rodents have demonstrated a potential to cause ototoxicity.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c47806e4-a23a-4914-8411-3917c17e6a35/documents/c0b82c10-164a-4691-8e0a-abf8536bdfd7_f596a745-1172-402a-91c2-83ba7b112c42.html,,,,,, p-xylene,106-42-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c47806e4-a23a-4914-8411-3917c17e6a35/documents/c0b82c10-164a-4691-8e0a-abf8536bdfd7_f596a745-1172-402a-91c2-83ba7b112c42.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat p-xylene,106-42-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c47806e4-a23a-4914-8411-3917c17e6a35/documents/c0b82c10-164a-4691-8e0a-abf8536bdfd7_f596a745-1172-402a-91c2-83ba7b112c42.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"3,515 mg/m3",,rat p-xylene,106-42-3," In animal studies xylenes exhibit low acute toxicity by oral (LD50 3,523 mg/kg), inhalation (4h LC50 27,124 mg/m3) and dermal (LD50 12,126 mg/kg) routes. In humans critical effects are irritation and CNS effects. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c47806e4-a23a-4914-8411-3917c17e6a35/documents/180b3b4e-5af2-4c35-943b-f2961be35b1c_f596a745-1172-402a-91c2-83ba7b112c42.html,,,,,, p-xylene,106-42-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c47806e4-a23a-4914-8411-3917c17e6a35/documents/180b3b4e-5af2-4c35-943b-f2961be35b1c_f596a745-1172-402a-91c2-83ba7b112c42.html,,oral,LD50,"3,523 mg/kg bw",no adverse effect observed, p-xylene,106-42-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c47806e4-a23a-4914-8411-3917c17e6a35/documents/180b3b4e-5af2-4c35-943b-f2961be35b1c_f596a745-1172-402a-91c2-83ba7b112c42.html,,dermal,LD50,"12,126 mg/kg bw",adverse effect observed, p-xylene,106-42-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c47806e4-a23a-4914-8411-3917c17e6a35/documents/180b3b4e-5af2-4c35-943b-f2961be35b1c_f596a745-1172-402a-91c2-83ba7b112c42.html,,inhalation,LC50,"27,124 mg/m3",adverse effect observed, "2,5-dimethyl-4-[2-methylsulfonyl-4-(trifluoromethyl)benzoyl]-1H-pyrazol-3-one",365400-11-9," subacute toxicity: OECD 410, dermal, rat, 28-days: NOAEL general toxicity 10 mg/kg bw/day subchronic toxicity: OECD 408, oral, rat, 90-days: NOAEL 30 ppm (equivalent to 1.96 mg/kg bw/day in males and 2.32 mg/kg bw/day in females) chronic toxicity: OECD 453, oral, rat, 6 months: NOAEL 25 ppm (eqivalent to 1.4 mg/kg bw/day in males and 1.8 mg/kg bw/day in females) OECD 453, oral, rat, 12 months: NOAEL 25 ppm (equivalent to 1.1 mg/kg bw/day in males and 1.5 mg/kg bw/day in females) OECD 453, oral rat, 24 months: NOAEL 25 ppm (equivalent to 1.0 mg/kg bw/day in males and 1.4 mg/kg bw/day in females) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/61c16456-aa6b-4f62-b9da-fbba040f120c/documents/c6a21304-54ce-4972-91e9-ddbaed15d92f_70d655f1-45ec-4d4f-a751-8030f6a84667.html,,,,,, "2,5-dimethyl-4-[2-methylsulfonyl-4-(trifluoromethyl)benzoyl]-1H-pyrazol-3-one",365400-11-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/61c16456-aa6b-4f62-b9da-fbba040f120c/documents/c6a21304-54ce-4972-91e9-ddbaed15d92f_70d655f1-45ec-4d4f-a751-8030f6a84667.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rat "2,5-dimethyl-4-[2-methylsulfonyl-4-(trifluoromethyl)benzoyl]-1H-pyrazol-3-one",365400-11-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/61c16456-aa6b-4f62-b9da-fbba040f120c/documents/c6a21304-54ce-4972-91e9-ddbaed15d92f_70d655f1-45ec-4d4f-a751-8030f6a84667.html,Chronic toxicity – systemic effects,oral,NOAEL,1 mg/kg bw/day,,rat "2,5-dimethyl-4-[2-methylsulfonyl-4-(trifluoromethyl)benzoyl]-1H-pyrazol-3-one",365400-11-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/61c16456-aa6b-4f62-b9da-fbba040f120c/documents/c6a21304-54ce-4972-91e9-ddbaed15d92f_70d655f1-45ec-4d4f-a751-8030f6a84667.html,Repeated dose toxicity – local effects,dermal,NOAEL,15 mg/cm2,no adverse effect observed,rat "2,5-dimethyl-4-[2-methylsulfonyl-4-(trifluoromethyl)benzoyl]-1H-pyrazol-3-one",365400-11-9," Oral (OECD 423), rat: LD50 > 2000 mg/kg bw (LD50 cut-off value = 5000 mg/kg bw according to OECD 423) Inhalation (OECD 403), rat: LC50 > 5000 mg/m3 air Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61c16456-aa6b-4f62-b9da-fbba040f120c/documents/6c8a4ee7-b801-4484-b3d7-125ee956d188_70d655f1-45ec-4d4f-a751-8030f6a84667.html,,,,,, "2,5-dimethyl-4-[2-methylsulfonyl-4-(trifluoromethyl)benzoyl]-1H-pyrazol-3-one",365400-11-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61c16456-aa6b-4f62-b9da-fbba040f120c/documents/6c8a4ee7-b801-4484-b3d7-125ee956d188_70d655f1-45ec-4d4f-a751-8030f6a84667.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,5-dimethyl-4-[2-methylsulfonyl-4-(trifluoromethyl)benzoyl]-1H-pyrazol-3-one",365400-11-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61c16456-aa6b-4f62-b9da-fbba040f120c/documents/6c8a4ee7-b801-4484-b3d7-125ee956d188_70d655f1-45ec-4d4f-a751-8030f6a84667.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "2,5-dimethyl-4-[2-methylsulfonyl-4-(trifluoromethyl)benzoyl]-1H-pyrazol-3-one",365400-11-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61c16456-aa6b-4f62-b9da-fbba040f120c/documents/6c8a4ee7-b801-4484-b3d7-125ee956d188_70d655f1-45ec-4d4f-a751-8030f6a84667.html,,inhalation,LC50,"> 5,000 mg/m3",no adverse effect observed, Pyrazine-2-carboxylic acid,98-97-5," Acute toxicity: oral The acute toxicity study was predicted using OECD QSAR toolbox version 3.3 (2017); to evaluate the toxic effects of administration of pyrazine-2-carboxylic acid (CAS No. 98-97-5) in rat by the oral route. 50% mortality observed at 2538.02 mg/kg bw in treated rats. Therefore, the acute oral median lethal dose (LD50) of pyrazine-2-carboxylic acid in rat was estimated to be 2538.02 mg/kg b.wt. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5011b7d3-5109-4dbb-8473-8d3719f54b17/documents/01a8daa6-a0ac-4635-b1db-25b69cbb8a47_c7fe8a61-7411-4651-82c5-ef34a487f59e.html,,,,,, Pyrazine-2-carboxylic acid,98-97-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5011b7d3-5109-4dbb-8473-8d3719f54b17/documents/01a8daa6-a0ac-4635-b1db-25b69cbb8a47_c7fe8a61-7411-4651-82c5-ef34a487f59e.html,,oral,LD50,"2,538.02 mg/kg bw",no adverse effect observed, Pyrazole,288-13-1," 4-Week rat drinking water study NOAEL: 20 ppm (1.5 and 1.9 mg/kg/day for males and females, respectively); LOAEL: 100 ppm (7.3 and 9.2 mg/kg/day for males and females, respectively); OECD 407; Reliability = 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd333578-737f-4e14-a85a-e734efb0c79d/documents/b2d97c14-08be-48da-97b6-6dfc0ecf4ab1_6c51107a-54d0-4f8f-942b-07c3d0eaabd6.html,,,,,, Pyrazole,288-13-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd333578-737f-4e14-a85a-e734efb0c79d/documents/b2d97c14-08be-48da-97b6-6dfc0ecf4ab1_6c51107a-54d0-4f8f-942b-07c3d0eaabd6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,1.5 mg/kg bw/day,,rat Pyrazole,288-13-1, Oral: rat LD50: 1010 mg/kg bw. Reliability = 2 Dermal: rabbit LD50: 400 mg/kg. Standardized test protocol. Reliability = 2 Inhalation: rat 4 -hour LC50: >0.37 mg/L (maximum attainable concentration). OECD 403. Reliability = 1 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd333578-737f-4e14-a85a-e734efb0c79d/documents/6e754450-092e-4c0c-b981-0cbd2401fd73_6c51107a-54d0-4f8f-942b-07c3d0eaabd6.html,,,,,, Pyrazole,288-13-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd333578-737f-4e14-a85a-e734efb0c79d/documents/6e754450-092e-4c0c-b981-0cbd2401fd73_6c51107a-54d0-4f8f-942b-07c3d0eaabd6.html,,oral,LD50,"1,010 mg/kg bw",adverse effect observed, Pyrazole,288-13-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd333578-737f-4e14-a85a-e734efb0c79d/documents/6e754450-092e-4c0c-b981-0cbd2401fd73_6c51107a-54d0-4f8f-942b-07c3d0eaabd6.html,,dermal,LD50,400 mg/kg bw,adverse effect observed, Pyrene,129-00-0,"Mouse Subchronic Oral Bioassay (U.S. EPA. 1989. 13-Week Mouse Oral Subchronic Toxicity with Pyrene. TRL Study #042-012. Study conducted by Toxicity Research Laboratories, Muskegon, MI for the Office of Solid Waste, Washington, DC) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/71e2bfa5-7a69-4f58-aba5-7b38d64240d1/documents/IUC5-0668b45a-6e3b-4731-a722-e4c79d092db8_527d9e4f-3a31-4441-88c1-fbcb46aaecc0.html,,,,,, Pyrene,129-00-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/71e2bfa5-7a69-4f58-aba5-7b38d64240d1/documents/IUC5-0668b45a-6e3b-4731-a722-e4c79d092db8_527d9e4f-3a31-4441-88c1-fbcb46aaecc0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,mouse "2-Chloro-3-(2,2,2-trifluoroethoxy)pyridine",256473-04-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9135cfcd-50d2-4c5b-936d-1c2f5b7fd687/documents/IUC5-43456683-2f5b-41b1-a2e5-355ce655e259_efec5626-b025-4cf1-9854-6b393c668445.html,,oral,LD50,"2,000 mg/kg bw",, "2-Chloro-3-(2,2,2-trifluoroethoxy)pyridine",256473-04-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9135cfcd-50d2-4c5b-936d-1c2f5b7fd687/documents/IUC5-43456683-2f5b-41b1-a2e5-355ce655e259_efec5626-b025-4cf1-9854-6b393c668445.html,,dermal,LD50,"2,000 mg/kg bw",, "2-Chloro-3-(2,2,2-trifluoroethoxy)pyridine",256473-04-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9135cfcd-50d2-4c5b-936d-1c2f5b7fd687/documents/IUC5-43456683-2f5b-41b1-a2e5-355ce655e259_efec5626-b025-4cf1-9854-6b393c668445.html,,inhalation,LC50,5.724 mg/m3,, "Pyridine-2,4-dicarboxylic acid",499-80-9," Acute oral toxicity:  Acute oral toxicity dose (LD50) for 2,4-Pyridinedicarboxylic acid (CAS no: 499-80-9) was predicted based on OECD QSAR toolbox in rats 2942 mg/kg bw; Danish (Q)SAR Database in rats 5600 mg mg/kg bw and in mice 2900 mg mg/kg bw; and different studies available on structurally similar read across substances Isonicotinic acid (CAS no: 55-22-1) in rats 5000 mg/kg bw and in mice 3123 mg/kg bw; and Phthalic acid (CAS No: 88-99-3) for rats >5000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2,4-Pyridinedicarboxylic acid cannot be classified for acute oral toxicity. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for 2,4-Pyridinedicarboxylic acid (CAS no: 499-80-9) was predicted based on OECD QSAR toolbox 2633 mg/kg bwand differentstudies available for the structurally similar read across substance 1,4-Benzenedicarboxylic acid (100-21-0) >2000 mg/kg bw and 1,3-Benzenedicarboxylic acid (121-91-5) >2000 mg/kg bw. All these studies concluded that the LD50 value is>2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, 2,4-Pyridinedicarboxylic acid cannot be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd3323e2-56ac-49e5-aa74-519fc346b340/documents/070d07e7-bf41-4107-af4a-0706cfdf263f_dc25a9f4-c202-45b0-8d6b-741c6eca48af.html,,,,,, "Pyridine-2,4-dicarboxylic acid",499-80-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd3323e2-56ac-49e5-aa74-519fc346b340/documents/070d07e7-bf41-4107-af4a-0706cfdf263f_dc25a9f4-c202-45b0-8d6b-741c6eca48af.html,,oral,LD50,"2,942 mg/kg bw",no adverse effect observed, "Pyridine-2,4-dicarboxylic acid",499-80-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd3323e2-56ac-49e5-aa74-519fc346b340/documents/070d07e7-bf41-4107-af4a-0706cfdf263f_dc25a9f4-c202-45b0-8d6b-741c6eca48af.html,,dermal,LD50,"2,633 mg/kg bw",no adverse effect observed, Pyridinium dichromate,20039-37-6, The studies on acute toxicity do not need to be conducted because the substance is classified as corrosive to the skin (reference 7.2.1 -1). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1ad2a2bb-9f86-4513-906a-917c37ad939f/documents/bfbf2bd7-5409-4511-a9c7-a9a7a0ba6ba8_6d7df415-2ad8-4462-9a3d-4a9d033eac94.html,,,,,, "Pyridinium, 1-(phenylmethyl)-, ethyl methyl derivs., chlorides",68909-18-2, Due to the corrosive nature of the substance a it is considered that the effects of the substance are very likely to be limited to the site of contact. Testing for repeated dose toxicity was not performed for reasons of animal welfare. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9c1eb96-8507-41c4-a84e-a26c49c930ae/documents/IUC5-d7e68b47-b9d0-44e2-84b3-42de43c7d795_27a777ed-17e4-4deb-a88b-d2ddeaa4828e.html,,,,,, "Pyridinium, 1-(phenylmethyl)-, ethyl methyl derivs., chlorides",68909-18-2,No studies of the acute toxicity of MK92K are available. Waivers are proposed in accordance with Column 2 of Annexes VII and VIII of the REACH Regulation as the substance is corrosive. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9c1eb96-8507-41c4-a84e-a26c49c930ae/documents/IUC5-2d2b5ac4-869c-4e9d-b181-85919e4cb7de_27a777ed-17e4-4deb-a88b-d2ddeaa4828e.html,,,,,, "Pyridinium, 1,1'-[(6,13-dichloro-4,11-disulfo-3,10-triphenodioxazinediyl)bis[imino-2,1-ethanediylimino[6-[(2,5-disulfophenyl)amino]-1,3,5-triazine-4,2-diyl]]]bis[3-carboxy-, dihydroxide, bis(inner salt), hexasodium salt",79771-28-1, The NOAEL is >1000 mg/kg B.W. (OECD TG407). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35dd9c8f-224e-47d8-85d4-eb03f9a38c7b/documents/ee6357de-770e-4207-87a2-f42118edc28d_7afb54ce-654d-4d4d-9ef5-3d8a48525726.html,,,,,, "Pyridinium, 1,1'-[(6,13-dichloro-4,11-disulfo-3,10-triphenodioxazinediyl)bis[imino-2,1-ethanediylimino[6-[(2,5-disulfophenyl)amino]-1,3,5-triazine-4,2-diyl]]]bis[3-carboxy-, dihydroxide, bis(inner salt), hexasodium salt",79771-28-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/35dd9c8f-224e-47d8-85d4-eb03f9a38c7b/documents/ee6357de-770e-4207-87a2-f42118edc28d_7afb54ce-654d-4d4d-9ef5-3d8a48525726.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Pyridinium, 1,1'-[(6,13-dichloro-4,11-disulfo-3,10-triphenodioxazinediyl)bis[imino-2,1-ethanediylimino[6-[(2,5-disulfophenyl)amino]-1,3,5-triazine-4,2-diyl]]]bis[3-carboxy-, dihydroxide, bis(inner salt), hexasodium salt",79771-28-1, Acute toxicity: via oral route The LD50 of Everzol Blue ED-G(Everzol SB26) was greater than 5000 mg/kg B.W. (EPA OPPTS 870.1100 and OECD TG401).   Acute toxicity: via dermal route The LD50 of Everzol SB26 was greater than 2000 mg/kg B.W. (OECD TG402). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35dd9c8f-224e-47d8-85d4-eb03f9a38c7b/documents/086d8156-7de8-43f4-9088-2eaf0b809beb_7afb54ce-654d-4d4d-9ef5-3d8a48525726.html,,,,,, "Pyridinium, 1,1'-[(6,13-dichloro-4,11-disulfo-3,10-triphenodioxazinediyl)bis[imino-2,1-ethanediylimino[6-[(2,5-disulfophenyl)amino]-1,3,5-triazine-4,2-diyl]]]bis[3-carboxy-, dihydroxide, bis(inner salt), hexasodium salt",79771-28-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35dd9c8f-224e-47d8-85d4-eb03f9a38c7b/documents/086d8156-7de8-43f4-9088-2eaf0b809beb_7afb54ce-654d-4d4d-9ef5-3d8a48525726.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Pyridinium, 1,1'-[(6,13-dichloro-4,11-disulfo-3,10-triphenodioxazinediyl)bis[imino-2,1-ethanediylimino[6-[(2,5-disulfophenyl)amino]-1,3,5-triazine-4,2-diyl]]]bis[3-carboxy-, dihydroxide, bis(inner salt), hexasodium salt",79771-28-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35dd9c8f-224e-47d8-85d4-eb03f9a38c7b/documents/086d8156-7de8-43f4-9088-2eaf0b809beb_7afb54ce-654d-4d4d-9ef5-3d8a48525726.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Pyridinium, 1-[2-[[4-[[3-[2-[6-amino-1-hydroxy-3-sulfo-5-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-2-naphthalenyl]diazenyl]-4-sulfophenyl]amino]-4-oxobutyl]sulfonyl]ethyl]-3-carboxy-, inner salt, sodium salt (1:4)",2409921-75-9,Acute toxicity: via oral route The LD50 of CR SB3A was greater than 2000 mg/kg B.W. (OECD TG423) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd01537e-9802-4035-b504-2b36d1db7a40/documents/75e9086d-7bed-4a30-a5d9-7cbe358170ce_e4d3b6e0-bab6-4568-a002-1a946c7630ce.html,,,,,, "Pyridinium, 1-[2-[[4-[[3-[2-[6-amino-1-hydroxy-3-sulfo-5-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-2-naphthalenyl]diazenyl]-4-sulfophenyl]amino]-4-oxobutyl]sulfonyl]ethyl]-3-carboxy-, inner salt, sodium salt (1:4)",2409921-75-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd01537e-9802-4035-b504-2b36d1db7a40/documents/75e9086d-7bed-4a30-a5d9-7cbe358170ce_e4d3b6e0-bab6-4568-a002-1a946c7630ce.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "Pyridinium, 1-[4-[[4-[(4-amino-9,10-dihydro-9,10-dioxo-3-sulfo-1-anthracenyl)amino]cyclohexyl]amino]-6-[(2,5-disulfophenyl)amino]-1,3,5-triazin-2-yl]-3-carboxy-, inner salt, sodium salt (1:3)",1918149-24-2, Acute toxicity: via oral route The LD50 of CR SB08 was greater than 2000 mg/kg B.W. (OECD TG423). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bda899b4-27d0-4307-a94a-0c93d10b9cfc/documents/e15f88fc-0a05-4173-98de-9d6269e235ba_35c3c72e-3f0e-4237-b2e1-9e31f509285a.html,,,,,, "Pyridinium, 1-[4-[[4-[(4-amino-9,10-dihydro-9,10-dioxo-3-sulfo-1-anthracenyl)amino]cyclohexyl]amino]-6-[(2,5-disulfophenyl)amino]-1,3,5-triazin-2-yl]-3-carboxy-, inner salt, sodium salt (1:3)",1918149-24-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bda899b4-27d0-4307-a94a-0c93d10b9cfc/documents/e15f88fc-0a05-4173-98de-9d6269e235ba_35c3c72e-3f0e-4237-b2e1-9e31f509285a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "6-bromo-2-chloro-8-cyclopentyl-5-methyl-pydiro[2,3-d]pyrimidin-7-one",1016636-76-2,"A 7-day repeated dose study (Dunster J S, 2013) is available which is key study. The oral NOEL value of test substance is considered to be 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d58f4ec2-9113-4972-a68a-5696e7a2299f/documents/IUC5-7d4a38de-f1ff-4dac-a193-b4e037ff1440_b0a6ff31-8582-4b44-9e16-cb8a5f2969ed.html,,,,,, "6-bromo-2-chloro-8-cyclopentyl-5-methyl-pydiro[2,3-d]pyrimidin-7-one",1016636-76-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d58f4ec2-9113-4972-a68a-5696e7a2299f/documents/IUC5-7d4a38de-f1ff-4dac-a193-b4e037ff1440_b0a6ff31-8582-4b44-9e16-cb8a5f2969ed.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "6-bromo-2-chloro-8-cyclopentyl-5-methyl-pydiro[2,3-d]pyrimidin-7-one",1016636-76-2,"Acute oral toxicity: A primary oral toxicity study (Pooles A, 2013) was available which is key study. This study showed that the oral LD50 value of test substance is estimated to be greater than 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d58f4ec2-9113-4972-a68a-5696e7a2299f/documents/IUC5-8c209fe3-c9d8-47ae-8752-40d4bb6aa4dd_b0a6ff31-8582-4b44-9e16-cb8a5f2969ed.html,,,,,, "6-bromo-2-chloro-8-cyclopentyl-5-methyl-pydiro[2,3-d]pyrimidin-7-one",1016636-76-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d58f4ec2-9113-4972-a68a-5696e7a2299f/documents/IUC5-8c209fe3-c9d8-47ae-8752-40d4bb6aa4dd_b0a6ff31-8582-4b44-9e16-cb8a5f2969ed.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction mass of pyrimido[5,4-g]pteridine-2,4,6,8-tetramine and 2,6,8-triamino-pyrimido[5,4-g]pteridine-4(1H)-one",346709-25-9,"28 d (+14 d recovery), rat, gavage: NOAEL/NOEL >= 1000 mg/kg bw/d (GLP, OECD 407; NOTOX B.V. 2001) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea0bf1ec-e630-4f79-8a0b-d40cc7ca17f6/documents/IUC5-9d165038-e5dd-4081-9603-433e04422324_00af3b42-7efb-479e-ac7e-5ce56cf2cc52.html,,,,,, "Reaction mass of pyrimido[5,4-g]pteridine-2,4,6,8-tetramine and 2,6,8-triamino-pyrimido[5,4-g]pteridine-4(1H)-one",346709-25-9,"oral rat: LD50 > 2000 mg/kg bw; signs of toxicity: Hunched posture, uncoordinated movements and/or lethargy, piloerection (GLP, OECD 423; NOTOX B.V., 2001) dermal rat: LD50 > 2000 mg/kg bw; signs of toxicity: ptosis, hunched posture and/or piloerection (GLP, OECD 402; CIBA-Geigy, 1989) inhalation No data available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea0bf1ec-e630-4f79-8a0b-d40cc7ca17f6/documents/IUC5-5fbecfd2-b5ac-415f-966b-7114ac2efa7a_00af3b42-7efb-479e-ac7e-5ce56cf2cc52.html,,,,,, "Reaction mass of pyrimido[5,4-g]pteridine-2,4,6,8-tetramine and 2,6,8-triamino-pyrimido[5,4-g]pteridine-4(1H)-one",346709-25-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea0bf1ec-e630-4f79-8a0b-d40cc7ca17f6/documents/IUC5-5fbecfd2-b5ac-415f-966b-7114ac2efa7a_00af3b42-7efb-479e-ac7e-5ce56cf2cc52.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction mass of pyrimido[5,4-g]pteridine-2,4,6,8-tetramine and 2,6,8-triamino-pyrimido[5,4-g]pteridine-4(1H)-one",346709-25-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea0bf1ec-e630-4f79-8a0b-d40cc7ca17f6/documents/IUC5-5fbecfd2-b5ac-415f-966b-7114ac2efa7a_00af3b42-7efb-479e-ac7e-5ce56cf2cc52.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Pyrochlore, antimony lead yellow",8012-00-8," Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec3e2362-3b0e-4474-8ec5-d78a84f95876/documents/55240df1-e7fa-4fe8-8269-766f9e1416fc_bc8dd5da-bd3a-4f12-b217-5abd99e6a13d.html,,,,,, "Pyrochlore, antimony lead yellow",8012-00-8," Acute toxicity, oral: LD50 > 2000 mg Pyrochlore/kg b.w. Acute toxicity, inhalation: LC50  >5.11 mg/L air. (MMAD: 2.860 µm (GSD: 2.62)) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec3e2362-3b0e-4474-8ec5-d78a84f95876/documents/9211d8c8-41c9-479d-9094-9b1f1bb08224_bc8dd5da-bd3a-4f12-b217-5abd99e6a13d.html,,,,,, Pyrrolidine,123-75-1,"Under the conditions of an OECD 422 combined repeated dose toxicity study with the reproduction/developmental toxicity screening test in Wistar rats via vapour inhalation the following no observed adverse effect concentration (NOAEC) of pyrrolidine were determined:- NOAEC general, local toxicity at the respiratory tract = 50 mg/m³- NOAEC general, systemic toxicity = 150 mg/m³ (highest dose tested)- NOAEC reproductive performance and fertility = 150 mg/m³ (highest dose tested)- NOAEC developmental toxicity = 150 mg/m³ (highest dose tested) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45979cac-15ba-4f97-943f-0b98ded39dbd/documents/IUC5-79bfc861-f77b-4261-b3e9-889d213db2c3_a8889950-00df-496a-84d3-b9d1c8016d66.html,,,,,, Pyrrolidine,123-75-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45979cac-15ba-4f97-943f-0b98ded39dbd/documents/IUC5-79bfc861-f77b-4261-b3e9-889d213db2c3_a8889950-00df-496a-84d3-b9d1c8016d66.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,150 mg/m3,,rat Pyrrolidine,123-75-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45979cac-15ba-4f97-943f-0b98ded39dbd/documents/IUC5-79bfc861-f77b-4261-b3e9-889d213db2c3_a8889950-00df-496a-84d3-b9d1c8016d66.html,Repeated dose toxicity – local effects,inhalation,NOAEC,50 mg/m3,adverse effect observed,rat Pyrrolidine,123-75-1,"Acute oral toxicity:In an acute oral toxicity study performed similar to OECD Guideline 401, the LD50 for male and female rats after oral application was determined to be 430 mg/kg bw.Acute inhalation toxicity: In the key acute inhalation study (BASF 83/123, 1985) an LC50 of 11.7 mg/L for both sexes combined (confidence interval 10.6 - 12.9) was determined.Acute dermal toxicity:Pyrrolidine was found to be corrrosive to the skin, therefore no testing is required for toxicity via the dermal route according to (EC) Regulation No 1907/2006. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45979cac-15ba-4f97-943f-0b98ded39dbd/documents/IUC5-c25f4fb3-7617-4040-b0f3-d079b6557342_a8889950-00df-496a-84d3-b9d1c8016d66.html,,,,,, Pyrrolidine,123-75-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45979cac-15ba-4f97-943f-0b98ded39dbd/documents/IUC5-c25f4fb3-7617-4040-b0f3-d079b6557342_a8889950-00df-496a-84d3-b9d1c8016d66.html,,oral,LD50,430 mg/kg bw,adverse effect observed, Pyrrolidine,123-75-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45979cac-15ba-4f97-943f-0b98ded39dbd/documents/IUC5-c25f4fb3-7617-4040-b0f3-d079b6557342_a8889950-00df-496a-84d3-b9d1c8016d66.html,,inhalation,LC50,"11,700 mg/m3",adverse effect observed, "3-hydroxy-1,4-bis(2-methylphenyl)-2H-pyrrolo[3,4-c]pyrrol-6-one",84632-66-6,"The test item was administered orally by gavage to groups of 10 male and 10 female Sprague-Dawley rats at dose levels of 0 mg/kg body weight/day (vehicle CMC), 50 mg/kg bw/d, 200 mg/kg bw/d and 1000 mg/kg bw/d for 28 days (OECD guideline 407, EU method B.7, GLP conditions). Clinical examinations, clinical pathology, histopathology and gross pathology did not reveal any finding in treated animals. The no observed adverse effect level (NOAEL) for general systemic toxicity was 1000 mg/kg bw/d in both sexes. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6dc6dcd-7ae5-4613-a198-bb402a8259f5/documents/IUC5-6865c6f3-f764-4b7c-8b35-e74c68e64a9d_27f7ca45-cf8f-49ea-b174-18c68d820691.html,,,,,, "3-hydroxy-1,4-bis(2-methylphenyl)-2H-pyrrolo[3,4-c]pyrrol-6-one",84632-66-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a6dc6dcd-7ae5-4613-a198-bb402a8259f5/documents/IUC5-6865c6f3-f764-4b7c-8b35-e74c68e64a9d_27f7ca45-cf8f-49ea-b174-18c68d820691.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3-hydroxy-1,4-bis(2-methylphenyl)-2H-pyrrolo[3,4-c]pyrrol-6-one",84632-66-6,A single dose of the test item was administered orally or dermally to Wistar rats at concentrations of 2000 mg/kg bw. No mortality occurred. Clinical examiniation and gross necropsy did not reveal any findings. The LD50 after oral and dermal administration is therefore considered to be > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6dc6dcd-7ae5-4613-a198-bb402a8259f5/documents/IUC5-27343e33-984b-4b2b-83a0-42cbe3551507_27f7ca45-cf8f-49ea-b174-18c68d820691.html,,,,,, "3-hydroxy-1,4-bis(2-methylphenyl)-2H-pyrrolo[3,4-c]pyrrol-6-one",84632-66-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6dc6dcd-7ae5-4613-a198-bb402a8259f5/documents/IUC5-27343e33-984b-4b2b-83a0-42cbe3551507_27f7ca45-cf8f-49ea-b174-18c68d820691.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3-hydroxy-1,4-bis(2-methylphenyl)-2H-pyrrolo[3,4-c]pyrrol-6-one",84632-66-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6dc6dcd-7ae5-4613-a198-bb402a8259f5/documents/IUC5-27343e33-984b-4b2b-83a0-42cbe3551507_27f7ca45-cf8f-49ea-b174-18c68d820691.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3,6-diphenyl-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione",54660-00-3,"Oral: - according to OECD TG 407, GLP, 28d, rat, NOAEL(systemic) = 1000 mg/kg bw/d   Inhalation: - No studies on repeated dose toxicity for the inhalation route are available for the test substance. Therefore, read across from a analogue substance was performed: - read-across from 84632-65-5, according to OECD 413, GLP, rat, 90d (+13wk recovery), rat, NOAEC (systemic) = 38.2 mg/m^3 air, NOAEC (local) = 2.8 mg/m^3 air   Dermal: - No studies on repeated dose toxicity for the dermal route are available Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Read across, according to OECD TG 413, GLP, Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Read across, according to OECD TG 413, GLP, Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): According to OECD TG 407, GLP, Klimisch 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41b608df-fed0-4682-8afc-abb2c908980b/documents/IUC5-7d92a2c2-ce57-4a5d-a121-d6787485aa73_10bbdb57-be4a-416d-a841-117f06ab9e0f.html,,,,,, "3,6-diphenyl-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione",54660-00-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41b608df-fed0-4682-8afc-abb2c908980b/documents/IUC5-7d92a2c2-ce57-4a5d-a121-d6787485aa73_10bbdb57-be4a-416d-a841-117f06ab9e0f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,6-diphenyl-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione",54660-00-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41b608df-fed0-4682-8afc-abb2c908980b/documents/IUC5-7d92a2c2-ce57-4a5d-a121-d6787485aa73_10bbdb57-be4a-416d-a841-117f06ab9e0f.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,39.2 mg/m3,,rat "3,6-diphenyl-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione",54660-00-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/41b608df-fed0-4682-8afc-abb2c908980b/documents/IUC5-7d92a2c2-ce57-4a5d-a121-d6787485aa73_10bbdb57-be4a-416d-a841-117f06ab9e0f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,2.1 mg/m3,adverse effect observed,rat "3,6-diphenyl-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione",54660-00-3,"Oral: according to OECD TG 401, GLP, rat, LD50 (m/f) > 5000 mg/kg bw   Inhalation (inconclusive): read-across from CAS 84632-65-5 (bulk), according to OECD TG 403, GLP, rat, 4h, LC50 (m/f) > 2.25 mg/L air read-across from EC 465-080-5 (nano), according to OECD TG 403, GLP, rat, 4h, LC0 (m/f) = 1 mg/L air, LC 100 (m/f) = 5 mg/L air   Dermal: according to OECD TG 402, GLP, rat, occlusive, LD50 (m/f) > 2000 mg/kg bw   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): according to OECD TG 401, GLP, Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The database was considered to be inconclusive for classification due to contradictory results. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): according to OECD TG 402, GLP, Klimisch 1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41b608df-fed0-4682-8afc-abb2c908980b/documents/IUC5-0cecf304-9ae9-420c-a475-1e3b7bae5c0e_10bbdb57-be4a-416d-a841-117f06ab9e0f.html,,,,,, "3,6-diphenyl-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione",54660-00-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41b608df-fed0-4682-8afc-abb2c908980b/documents/IUC5-0cecf304-9ae9-420c-a475-1e3b7bae5c0e_10bbdb57-be4a-416d-a841-117f06ab9e0f.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "3,6-diphenyl-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione",54660-00-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/41b608df-fed0-4682-8afc-abb2c908980b/documents/IUC5-0cecf304-9ae9-420c-a475-1e3b7bae5c0e_10bbdb57-be4a-416d-a841-117f06ab9e0f.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3,6-Bis-biphenyl-4-yl-2,5-dihydro-pyrrolo[3,4-c]-pyrrole-1,4-dione",88949-33-1,"Oral: - according to OECD TG 407, GLP, 28d (+ 14d recovery), rat, NOAEL(systemic) = 1000 mg/kg bw/d   Inhalation: - No studies on repeated dose toxicity for the inhalation route are available for the test substance. Therefore, read across from a analogue substance was performed: - read-across from 84632-65-5(bulk), according to OECD 413, GLP, rat, 90d (+13wk recovery), rat, NOAEC (systemic) = 38.2 mg/m^3 air, NOAEC (local) = 2.8 mg/m^3 air   Dermal: - No studies on repeated dose toxicity for the dermal route are available Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Read across, according to OECD TG 413, GLP, Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Read across, according to OECD TG 413, GLP, Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): According to OECD TG 407, GLP, Klimisch 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1aa4cb36-47bf-40ec-84dd-fdb15be59d02/documents/IUC5-367b2dbb-beba-4ceb-965c-688cdf318188_95296c94-1baa-4cbd-8ebd-3f6f3d544ba5.html,,,,,, "3,6-Bis-biphenyl-4-yl-2,5-dihydro-pyrrolo[3,4-c]-pyrrole-1,4-dione",88949-33-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1aa4cb36-47bf-40ec-84dd-fdb15be59d02/documents/IUC5-367b2dbb-beba-4ceb-965c-688cdf318188_95296c94-1baa-4cbd-8ebd-3f6f3d544ba5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,6-Bis-biphenyl-4-yl-2,5-dihydro-pyrrolo[3,4-c]-pyrrole-1,4-dione",88949-33-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1aa4cb36-47bf-40ec-84dd-fdb15be59d02/documents/IUC5-367b2dbb-beba-4ceb-965c-688cdf318188_95296c94-1baa-4cbd-8ebd-3f6f3d544ba5.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,39.2 mg/m3,,rat "3,6-Bis-biphenyl-4-yl-2,5-dihydro-pyrrolo[3,4-c]-pyrrole-1,4-dione",88949-33-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1aa4cb36-47bf-40ec-84dd-fdb15be59d02/documents/IUC5-367b2dbb-beba-4ceb-965c-688cdf318188_95296c94-1baa-4cbd-8ebd-3f6f3d544ba5.html,Repeated dose toxicity – local effects,inhalation,NOAEC,2.1 mg/m3,adverse effect observed,rat "3,6-Bis-biphenyl-4-yl-2,5-dihydro-pyrrolo[3,4-c]-pyrrole-1,4-dione",88949-33-1,"Oral: according to OECD TG 401, GLP, rat, LD50 (m/f) >2000 mg/kg bw   Inhalation (inconclusive): read-across from CAS 84632-65-5 (bulk), according to OECD TG 403, GLP, rat, 4h, LC50 (m/f) >2.25 mg/L air read-across from EC 465-080-5 (nano), according to OECD TG 403, GLP, rat, 4h, LC0 (m/f) = 1 mg/L air, LC 100 (m/f) = 5 mg/L air   Dermal: according to OECD TG 402, GLP, rat, semi-occlusive, LD50 (m/f) >2000 mg/kg bw Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): according to OECD TG 401, GLP, Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The database was considered to be inconclusive for classification due to contradictory results. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): according to OECD TG 402, GLP, Klimisch 1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aa4cb36-47bf-40ec-84dd-fdb15be59d02/documents/IUC5-d390d37c-642b-4dc8-b7b2-f752abfb1ee3_95296c94-1baa-4cbd-8ebd-3f6f3d544ba5.html,,,,,, "3,6-Bis-biphenyl-4-yl-2,5-dihydro-pyrrolo[3,4-c]-pyrrole-1,4-dione",88949-33-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aa4cb36-47bf-40ec-84dd-fdb15be59d02/documents/IUC5-d390d37c-642b-4dc8-b7b2-f752abfb1ee3_95296c94-1baa-4cbd-8ebd-3f6f3d544ba5.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3,6-Bis-biphenyl-4-yl-2,5-dihydro-pyrrolo[3,4-c]-pyrrole-1,4-dione",88949-33-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aa4cb36-47bf-40ec-84dd-fdb15be59d02/documents/IUC5-d390d37c-642b-4dc8-b7b2-f752abfb1ee3_95296c94-1baa-4cbd-8ebd-3f6f3d544ba5.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "3,6-bis(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione",84632-65-5,"In a 28-day repeated dose oral toxicity study (acc. to OECD 421), the substance did not induce any toxicity up to the dose of 1000 mg/kg/day.   In a non-guideline supportive study, male rats were exposed in a nose-only set-up to dusty material at a single dose of 30 mg/m3 air for five days/6h per day with the substance and with the substance's nanoform. Examinations were performed both after exposure and at the end of a 21 -day treatment free recovery period. Parameters examined adressed systemic effects (clinical chemistry, haematology, organ weights) and local effects on the lung (broncheoalveolar lavage, histopathology) and were obtained from groups of either three or five animals. Directly after exposure and after 3 weeks recovery, no indication of systemic toxicity were observed. Histopathological findings were present and are regarded as treatment-related, but since no tissue injury was present in the examined respiratory organs, all of them are considered to be adaptive and not adverse. In a GLP-compliant 90-days inhalation toxicity study according to OECD TG 413, rats were exposed by nose-only to 2, 8 and 40 mg/m3 (nominal). The study included a satellite group and two recovery groups (for 4 and 13 weeks) to measure lung burden and analyse the BALF. No systemic effects were observed and adverse local changes in the respiratory tract were limited to the Mid and High Concentration groups treated with test item. Based on these results, the No Observed Adverse Effect Concentration (NOAEC) for the study was 2.1 mg/m3 (Low Concentration group). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): The whole database is determined by two available studies, which are reliable and have consistent results.. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The whole database is determined by two available studies, which are reliable and have consistent results.. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The quality of the whole database is determined by the only avaliable study, which is reliable and of good quality. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3028606f-f71c-435f-a62f-472b675866a7/documents/9ebd4caf-e1ac-41d2-8f13-19ef829a40b6_899d645b-e367-4ca4-824b-eaaa77f68202.html,,,,,, "3,6-bis(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione",84632-65-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3028606f-f71c-435f-a62f-472b675866a7/documents/9ebd4caf-e1ac-41d2-8f13-19ef829a40b6_899d645b-e367-4ca4-824b-eaaa77f68202.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "3,6-bis(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione",84632-65-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3028606f-f71c-435f-a62f-472b675866a7/documents/9ebd4caf-e1ac-41d2-8f13-19ef829a40b6_899d645b-e367-4ca4-824b-eaaa77f68202.html,Repeated dose toxicity – local effects,inhalation,NOAEC,2.1 mg/m3,adverse effect observed,rat "3,6-bis(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione",84632-65-5, Acute toxicity oral: LD50: > 2000 mg/kg bw Acute toxicity inhalation: LD50 : > 2.25 mg/L Acute toxicity dermal: LD50: > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3028606f-f71c-435f-a62f-472b675866a7/documents/IUC5-ab1441a0-a227-4565-b236-fe91cb38c2b0_899d645b-e367-4ca4-824b-eaaa77f68202.html,,,,,, "3,6-bis(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione",84632-65-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3028606f-f71c-435f-a62f-472b675866a7/documents/IUC5-ab1441a0-a227-4565-b236-fe91cb38c2b0_899d645b-e367-4ca4-824b-eaaa77f68202.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3,6-bis(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione",84632-65-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3028606f-f71c-435f-a62f-472b675866a7/documents/IUC5-ab1441a0-a227-4565-b236-fe91cb38c2b0_899d645b-e367-4ca4-824b-eaaa77f68202.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "3,6-bis(4-chlorophenyl)-2,5-dihydropyrrolo[3,4-c]pyrrole-1,4-dione",84632-65-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3028606f-f71c-435f-a62f-472b675866a7/documents/IUC5-ab1441a0-a227-4565-b236-fe91cb38c2b0_899d645b-e367-4ca4-824b-eaaa77f68202.html,,inhalation,LC50,"2,250 mg/m3",no adverse effect observed, "3,6-Bis-(4-tert-butyl-phenyl)-2,5-dihydro-pyrrolo[3,4-c]pyrrole-1,4-dione",84632-59-7,"Pigment Orange 73 showed no adverse effects at the limit dose of 1000 mg/kg bw upon subacute gavage dosing in rats (OECD 407, GLP) (RCC Ltd 1994). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f5055aa0-f1e6-4be9-afa0-0d01121bc06d/documents/IUC5-378e53a1-cccd-4239-b427-3ba3a7305bdb_87fe0017-def1-48a0-812f-0f3ff04ee684.html,,,,,, "3,6-Bis-(4-tert-butyl-phenyl)-2,5-dihydro-pyrrolo[3,4-c]pyrrole-1,4-dione",84632-59-7,"- Acute oral toxicity according to OECD TG 423, rats; LD50 > 2000 mg/kg bw; no mortality occurred and no signs of systemic toxicity were observed up to 2000 mg/kg bw (Ciba-Geigy Ltd 1993a).- Acute dermal toxicity: LD50 > 2000 mg/kg bw (OECD 402, GLP), (RCC Ltd (1993a).- Acute inhalation toxicity: LC50 > 2.2 mg/L (highest attainable concentration, read-across to Pigment Red 254, EC 401-540-3, OECD 403, GLP, Ciba 1991) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f5055aa0-f1e6-4be9-afa0-0d01121bc06d/documents/IUC5-b6b1b665-7d4f-408c-918c-d55ec5328a28_87fe0017-def1-48a0-812f-0f3ff04ee684.html,,,,,, Pyruvaldehyde,78-98-8,"No guideline compatible repeated dose study or a study with broad toxicological background is available. Instead, data from four publications (for details see discussion) were considered, but were insufficient to characterize repeated dose endpoints of the substance.In accordance with the REACH legislation only the available data have to be presented. A specific study is not required (Article 18 or Annex VII). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c9b994f5-c488-4eff-9c27-95597ae8c520/documents/IUC5-f10434a1-1098-47b6-a2c1-02e176d3d884_b184021e-94b7-431e-88e9-a20ef6ec640d.html,,,,,, Pyruvaldehyde,78-98-8,The oral LD50 value of the test item in rats is ca. 1380 mg/kg bw (calculated from nominal dose (30% solution) in study report: 5000 mg/kg bw).An 7h inhalation exposure of rats to an atmosphere enriched with the test item caused no deaths. The LC50 was >13.6 mg/L and was calculated from the net total of 19.1 g test item applied within 1400 L air. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9b994f5-c488-4eff-9c27-95597ae8c520/documents/IUC5-98ae8d29-062e-4111-92c2-0f887adab9e7_b184021e-94b7-431e-88e9-a20ef6ec640d.html,,,,,, Pyruvaldehyde,78-98-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9b994f5-c488-4eff-9c27-95597ae8c520/documents/IUC5-98ae8d29-062e-4111-92c2-0f887adab9e7_b184021e-94b7-431e-88e9-a20ef6ec640d.html,,oral,LD50,"1,380 mg/kg bw",, "Quaternary ammonium compounds, (C16-18 and C18-unsatd. alkyl)trimethyl, chlorides",68002-61-9,"Overall, considering the repeated dose studies with the structurally similar substances (e.g., TMAC C) as mentioned in the Biocides assessment report, the main critical effects associated with these substances were due to their corrosive properties. The systemic effects such as the reduction of body weight and food consumption were considered to be secondary compared to the corrosive properties of the substances. Therefore, in the absence of ‘true’ systemic effects and in line with the biocides assessment reports, the derivation of a systemic DNEL has been considered to be non-relevant and only a qualitative local risk assessment has been conducted for the registered substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): Due to some deficiencies in the study, the 90-day oral study has not been considered further for hazard and risk assessment. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): The registered substance has been classified as corrosive (no threshold derived) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline compliant study with a structurally similar substance ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1433dad7-1aed-4cc9-83f2-775ee6836d88/documents/8bef6d1b-061c-40f1-9c35-be4d690e948e_b5497314-8b4b-4d7d-86d4-55923945b2f0.html,,,,,, "Quaternary ammonium compounds, (C16-18 and C18-unsatd. alkyl)trimethyl, chlorides",68002-61-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1433dad7-1aed-4cc9-83f2-775ee6836d88/documents/8bef6d1b-061c-40f1-9c35-be4d690e948e_b5497314-8b4b-4d7d-86d4-55923945b2f0.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rabbit "Quaternary ammonium compounds, (C16-18 and C18-unsatd. alkyl)trimethyl, chlorides",68002-61-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1433dad7-1aed-4cc9-83f2-775ee6836d88/documents/8bef6d1b-061c-40f1-9c35-be4d690e948e_b5497314-8b4b-4d7d-86d4-55923945b2f0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40.3 mg/kg bw/day,,rat "Quaternary ammonium compounds, (C16-18 and C18-unsatd. alkyl)trimethyl, chlorides",68002-61-9," The oral LD50 value of the test substance was determined to be 630 mg a.i./kg bw in rats, suggesting a moderate acute toxicity potential. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliable OECD guideline acute oral toxicity study available, meeting the tonnage information requirements. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1433dad7-1aed-4cc9-83f2-775ee6836d88/documents/IUC5-19f56ccd-add9-4578-b4ce-bc5c208f1f53_b5497314-8b4b-4d7d-86d4-55923945b2f0.html,,,,,, "Quaternary ammonium compounds, (C16-18 and C18-unsatd. alkyl)trimethyl, chlorides",68002-61-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1433dad7-1aed-4cc9-83f2-775ee6836d88/documents/IUC5-19f56ccd-add9-4578-b4ce-bc5c208f1f53_b5497314-8b4b-4d7d-86d4-55923945b2f0.html,,oral,LD50,630 mg/kg bw,adverse effect observed, "N-C16-C18(even numbered, C18 unsaturated)-alkyl-N,N-dimethyl-C16-C18(even numbered, C18 unsaturated)-alkyl-1-aminium chloride",1228186-17-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/230c3fb6-8c54-44ad-b106-4f647a995e8b/documents/IUC5-36e21250-10d2-4282-a5c8-f33c413324b7_4c8d2526-3849-486f-8f0d-c5698baaf7f6.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,46 mg/kg bw/day,,rat "N-C16-C18(even numbered, C18 unsaturated)-alkyl-N,N-dimethyl-C16-C18(even numbered, C18 unsaturated)-alkyl-1-aminium chloride",1228186-17-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/230c3fb6-8c54-44ad-b106-4f647a995e8b/documents/IUC5-c72419e3-e2ba-4443-ac81-89647cb2468f_4c8d2526-3849-486f-8f0d-c5698baaf7f6.html,,oral,LD50,"2,000 mg/kg bw",, "N-C16-C18(even numbered, C18 unsaturated)-alkyl-N,N-dimethyl-C16-C18(even numbered, C18 unsaturated)-alkyl-1-aminium chloride",1228186-17-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/230c3fb6-8c54-44ad-b106-4f647a995e8b/documents/IUC5-c72419e3-e2ba-4443-ac81-89647cb2468f_4c8d2526-3849-486f-8f0d-c5698baaf7f6.html,,dermal,LD50,"2,000 mg/kg bw",, "Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides, reaction products with polyethylenepolyamines and tall-oil fatty acids, humates hydrochlorides",68910-55-4," There were no key oral or dermal repeated dose studies conducted because these study types are not warranted or appropriate.  Repeated dose oral toxicity studies were not appropriate because oral exposure for workers is not relevantan no exposure of the general population is expected. Repeated dose dermal toxicity studies were not warranted because of the physicochemical properties of organolignite. In a subchronic repeated dose toxicity study (OECD 413) via inhalation exposure no NOAEC could be established. A lung overload, i.e. an inflammatory response and correlated changes in haematology and histopathology parameters was observed in all dose groups. This effect is considered to be a local effect. The systemic effects are secondary effects. Therefore, 40 µg/L (40 mg/m³) is considered as local LOAEC and for systemic effects the NOAEL is established as 400 µg/L (400 mg/m³). In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422) via inhalation exposure, the NOAEC was established at 300 mg/m³ (i.e., the high dose) based on the lack of adverse local and systemic effects observed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb7526f3-9d46-4613-a9d8-543558efbe4e/documents/6ba4690b-3f2e-4234-989f-da36c77c6216_6981cfd4-2d92-41af-b778-d4779649e4aa.html,,,,,, "Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides, reaction products with polyethylenepolyamines and tall-oil fatty acids, humates hydrochlorides",68910-55-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb7526f3-9d46-4613-a9d8-543558efbe4e/documents/6ba4690b-3f2e-4234-989f-da36c77c6216_6981cfd4-2d92-41af-b778-d4779649e4aa.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,400 mg/m3,,rat "Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides, reaction products with polyethylenepolyamines and tall-oil fatty acids, humates hydrochlorides",68910-55-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb7526f3-9d46-4613-a9d8-543558efbe4e/documents/6ba4690b-3f2e-4234-989f-da36c77c6216_6981cfd4-2d92-41af-b778-d4779649e4aa.html,Repeated dose toxicity – local effects,inhalation,LOAEC,40 mg/m3,adverse effect observed,rat "Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides, reaction products with polyethylenepolyamines and tall-oil fatty acids, humates hydrochlorides",68910-55-4," OECD (420, 402, and 403) compliant studies were identified for organolignite and resulted in the following LD50s. • The oral LD50 in female rats was > 2000 mg/kg. • The dermal LD50 in male and female rats was > 2000 mg/kg. • The inhalation LC50 in male and female rats was > 2170 mg/m3. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb7526f3-9d46-4613-a9d8-543558efbe4e/documents/5ee011ef-a27e-4c0f-bad5-e7d9872b16ba_6981cfd4-2d92-41af-b778-d4779649e4aa.html,,,,,, "Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides, reaction products with polyethylenepolyamines and tall-oil fatty acids, humates hydrochlorides",68910-55-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb7526f3-9d46-4613-a9d8-543558efbe4e/documents/5ee011ef-a27e-4c0f-bad5-e7d9872b16ba_6981cfd4-2d92-41af-b778-d4779649e4aa.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides, reaction products with polyethylenepolyamines and tall-oil fatty acids, humates hydrochlorides",68910-55-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb7526f3-9d46-4613-a9d8-543558efbe4e/documents/5ee011ef-a27e-4c0f-bad5-e7d9872b16ba_6981cfd4-2d92-41af-b778-d4779649e4aa.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Quaternary ammonium compounds, bis(hydrogenated tallow alkyl)dimethyl, chlorides, reaction products with polyethylenepolyamines and tall-oil fatty acids, humates hydrochlorides",68910-55-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb7526f3-9d46-4613-a9d8-543558efbe4e/documents/5ee011ef-a27e-4c0f-bad5-e7d9872b16ba_6981cfd4-2d92-41af-b778-d4779649e4aa.html,,inhalation,LC50,"2,170 mg/m3",no adverse effect observed, "N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride",1125503-33-4," Only limited animal data on repeated dose application are available for Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl) dimethyl, chlorides (HYEQS). The assessment of the endpoint repeated dose toxicity is based on read across to an oral (dietary) repeated dose toxicity study in rats according to OECD 408 with the chemically closely related compound SS0772.01 (i.e. C8-C10 alkyl dimethyl hydroxyethyl ammonium chloride) which is used here as surrogate substance (For Read across justification refer to IUCLID section 13 Assessment reports). The use as surrogate is justified as it is seen as a worst case, i. e. based on the shorter chain length, its lower molecular weight and thus its higher chemical reactivity. However, with HYEQS as relevant test substance an OECD 422 study is available which allows an evaluation of repeated oral dosing in males and females for 29 days and at least 53 days, respectively. Based on the absence of any toxicological relevant effects observed with the analogue compound SS0772.01 a clear no observed effect level (NOEL) at 50 mg/kg bw/day was established. Only minor effects not considered being adverse were revealed at the next higher dose of 75 mg/kg bw/day which was considered to be a NOAEL. Taking a conservative approach the NOEL of 50 mg/kg bw/day will be used for the CSA.With regard to dermal toxicity, repeated dermal treatment for at least 12 weeks with the C13-C15 analogue substance E3333.01 revealed local signs of irritation but no effects attributable to direct systemic toxicity. A NO(A)EL regarding systemic effects was therefore not established. Under the conditions of the study the NO(A)EC for dermal local toxicity (irritation) was determined to be 0.02% w/v. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c69295d9-e7a9-417c-8514-b9e7a630230e/documents/IUC5-ee891f74-5233-436b-a625-506206cff01c_b67b526e-778c-4621-8beb-90d07ef8ad3d.html,,,,,, "N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride",1125503-33-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c69295d9-e7a9-417c-8514-b9e7a630230e/documents/IUC5-ee891f74-5233-436b-a625-506206cff01c_b67b526e-778c-4621-8beb-90d07ef8ad3d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride",1125503-33-4,"The acute oral median lethal dose (LD50) of Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl) dimethyl, chlorides (HYEQS), to the Sprague-Dawley strain rat was found to be greater than 200 mg/kg body weight but less than 2000 mg/kg bodyweight (nominal concentration). The study was performed with a 35% (w/v) solution in water according to OECD 401. In a second study (up and down method according to OECD 425) with an analogue quaternary ammonium compound (C13-15 dimethyl hydroxyethylammonium chloride) which is similar in structure (for Read across justification refer to IUCLID section 13, Assessment reports), the LD50 was determined to be 1300 mg/kg bw (nominal concentration). The active ingredient /purity of this substance were approx. 30 % (w/v) solution in water. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c69295d9-e7a9-417c-8514-b9e7a630230e/documents/IUC5-4b388b59-7b3c-4b0b-bad2-a085fd86b0cf_b67b526e-778c-4621-8beb-90d07ef8ad3d.html,,,,,, "N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride",1125503-33-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c69295d9-e7a9-417c-8514-b9e7a630230e/documents/IUC5-4b388b59-7b3c-4b0b-bad2-a085fd86b0cf_b67b526e-778c-4621-8beb-90d07ef8ad3d.html,,oral,LD50,"1,000 mg/kg bw",, "Quaternary ammonium compounds, C12-14-alkyltrimethyl, Me sulfates",96690-44-7," Based on the results of the 90-day and 28 -day studies with the read across substance, Coco TMAC and C16 -TMAC in rats respectively, the NOAEL of 40.3 mg a.i./kg bw/day has been considered further for the hazard assessment of the test substance, Quaternary ammonium compounds, C12-14 alkyltrimethyl, Me sulfates. Overall, considering that the available studies revealed NOAELs based on reduction in body weight and body weight gain (consistent with decreased food consumption), it can be concluded that all effects could be attributed to local gastrointestinal irritaton/corrosion and consequent reduced food intake without observing any primary systemic effect. Therefore, the derivation of a DNEL for systemic effects was deemed inappropriate. With regard to the dermal route, due to deficiencies in the available 28 -day dermal toxicity study with read across substance, C16 TMAC (reduced number of test animals per group and limited histopathology), the 90-day oral study with read across substance can be considered for the systemic hazard assessment of the test substance, Quaternary ammonium compounds, C12-14 alkyltrimethyl, Me sulfates. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8cd5b0f-0eea-42a8-a019-d0dbf538bc2d/documents/c9c6641c-d77e-4b88-b2ab-b45639a3632a_f32d96e6-0740-4fe7-882a-f3c275eb81c2.html,,,,,, "Quaternary ammonium compounds, C12-14-alkyltrimethyl, Me sulfates",96690-44-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8cd5b0f-0eea-42a8-a019-d0dbf538bc2d/documents/c9c6641c-d77e-4b88-b2ab-b45639a3632a_f32d96e6-0740-4fe7-882a-f3c275eb81c2.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rabbit "Quaternary ammonium compounds, C12-14-alkyltrimethyl, Me sulfates",96690-44-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8cd5b0f-0eea-42a8-a019-d0dbf538bc2d/documents/c9c6641c-d77e-4b88-b2ab-b45639a3632a_f32d96e6-0740-4fe7-882a-f3c275eb81c2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40.3 mg/kg bw/day,,rat "Quaternary ammonium compounds, C12-14-alkyltrimethyl, Me sulfates",96690-44-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Good quality Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Good quality ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8cd5b0f-0eea-42a8-a019-d0dbf538bc2d/documents/3b351e65-fece-4414-b533-24677592be9d_f32d96e6-0740-4fe7-882a-f3c275eb81c2.html,,,,,, "Quaternary ammonium compounds, C12-14-alkyltrimethyl, Me sulfates",96690-44-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8cd5b0f-0eea-42a8-a019-d0dbf538bc2d/documents/3b351e65-fece-4414-b533-24677592be9d_f32d96e6-0740-4fe7-882a-f3c275eb81c2.html,,oral,LD50,570 mg/kg bw,adverse effect observed, "Quaternary ammonium compounds, C12-14-alkyltrimethyl, Me sulfates",96690-44-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8cd5b0f-0eea-42a8-a019-d0dbf538bc2d/documents/3b351e65-fece-4414-b533-24677592be9d_f32d96e6-0740-4fe7-882a-f3c275eb81c2.html,,dermal,LD50,528 mg/kg bw,adverse effect observed, "Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides",71808-53-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study is performed according to OECD 408 guideline and under GLP and has reliability rating 1. It is sufficient to cover the information requirements in Annex IX. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af4036cb-bc85-41a8-83c8-a18cdd99847a/documents/IUC5-fd17879b-db8a-410f-972b-b2859cee16a0_c4d52180-9ba2-471b-b241-db471e12f488.html,,,,,, "Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides",71808-53-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af4036cb-bc85-41a8-83c8-a18cdd99847a/documents/IUC5-fd17879b-db8a-410f-972b-b2859cee16a0_c4d52180-9ba2-471b-b241-db471e12f488.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,24 mg/kg bw/day,,rat "Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides",71808-53-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): In accordance with column 2 of REACH Annex VII, an acute oral toxicity study does not need to be conducted as the substance is classified as corrosive. Since two studies were already available, although with validity rating 2 and 3, the most recent performed study with the highest validity rating is used in order to classify the substance. Both the key study and the supporting study indicates GHS cat. 4 (LD50 between 300 and 2000 mg/kg). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af4036cb-bc85-41a8-83c8-a18cdd99847a/documents/IUC5-a7177613-911c-4f07-8508-c0758f363128_c4d52180-9ba2-471b-b241-db471e12f488.html,,,,,, "Quaternary ammonium compounds, C12-18-alkylbis(hydroxyethyl)methyl, chlorides",71808-53-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af4036cb-bc85-41a8-83c8-a18cdd99847a/documents/IUC5-a7177613-911c-4f07-8508-c0758f363128_c4d52180-9ba2-471b-b241-db471e12f488.html,,oral,LD50,"1,420 mg/kg bw",adverse effect observed, "Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides",68607-24-9," The registrations substance was tested in a 28-day oral gavage study in rats that received daily doses of 0, 10, 50 and 150 mg/kg/d. One male of the high dose group died and two females of the high dose group had to be humanely killed during the treatment period. In a dose dependent fashion, animals at 50 and 150 mg/kg/d showed various effects on body weight, hematology, clinical chemistry, organ weights, macroscopic and microscopic examination. In animals at 10 mg/kg/d, mesenteric lymph nodes were affected to a minimal or mild degree only and no further treatment-related changes were noted. NOAEL of 10 mg/kg/d was obtained. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7d3a160-a787-4bdc-9039-1b1c4de74895/documents/79e56e5b-dc9b-4d39-b542-e00d5d745c0c_245b7751-c35b-4bd7-93f0-018b40586380.html,,,,,, "Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides",68607-24-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d7d3a160-a787-4bdc-9039-1b1c4de74895/documents/79e56e5b-dc9b-4d39-b542-e00d5d745c0c_245b7751-c35b-4bd7-93f0-018b40586380.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides",68607-24-9, The registration substance is of no significant toxicity for oral and dermal routes. The acute inhalation toxicity is of no relevance for the risk assessment. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7d3a160-a787-4bdc-9039-1b1c4de74895/documents/fb109bf1-5ed2-401c-91b4-26ba89443594_245b7751-c35b-4bd7-93f0-018b40586380.html,,,,,, "Quaternary ammonium compounds, C20-22-alkyltrimethyl, chlorides",68607-24-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7d3a160-a787-4bdc-9039-1b1c4de74895/documents/fb109bf1-5ed2-401c-91b4-26ba89443594_245b7751-c35b-4bd7-93f0-018b40586380.html,,oral,LD50,"3,190 mg/kg bw",no adverse effect observed, "Quaternary ammonium compounds, di-C14-18-alkyldimethyl, Me sulfates",68002-58-4," subchronic NOAEL = 100 mg/kg bw/d; WoE; read-across from DODMAC, DHTDMAC, DHTDMAMS, DDAC, cetrimonium bromide and cetrimonium chloride ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ad80b66-067d-469b-a790-d77901fdc2b5/documents/c0ad66a6-d7e2-4cd9-9492-dd04e13fe4b5_0a1e5247-f63c-4302-a83b-88296bc1176f.html,,,,,, "Quaternary ammonium compounds, di-C14-18-alkyldimethyl, Me sulfates",68002-58-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ad80b66-067d-469b-a790-d77901fdc2b5/documents/c0ad66a6-d7e2-4cd9-9492-dd04e13fe4b5_0a1e5247-f63c-4302-a83b-88296bc1176f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Quaternary ammonium compounds, di-C14-18-alkyldimethyl, Me sulfates",68002-58-4," Acute oral toxicity: LD50 > 10000 mg/kg bw, performed before implementation of GLP and OECD guidelines; RL2   Acute inhalation toxicity: exposure consideration + no acute intrinsic toxicity expected; no testing required    Acute dermal toxicity: LD50 expected to be > 2000 mg/kg bw; no testing required  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ad80b66-067d-469b-a790-d77901fdc2b5/documents/d4912b14-d095-48a7-8780-6249589fa242_0a1e5247-f63c-4302-a83b-88296bc1176f.html,,,,,, "Quaternary ammonium compounds, di-C14-18-alkyldimethyl, Me sulfates",68002-58-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ad80b66-067d-469b-a790-d77901fdc2b5/documents/d4912b14-d095-48a7-8780-6249589fa242_0a1e5247-f63c-4302-a83b-88296bc1176f.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Quaternary ammonium compounds, dicoco alkyldimethyl, nitrites",71487-01-9," Read across data is presented on the ""fragments"" from which this substance is manufactured :- Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides, CAS Number 68391-05-9, EC Number 269-924-1 and from sodium nitrite, CAS Number 7632-00-0, EC Number 231-555-9. The justification in taking this approach is as follows :- In the stomach the gastic juice is acidic, made up of acids and enzymes. In such an evironment it is highly unlikely that the quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites substance (s) will remain ionically bound to each other and thus are prone to dissociation in which case the released cation(s) will associate with other anions and the released anion will associate with cations. Thererfore, it is suggested read-across data from the corresponding quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides is considered approriate in that such substances are likely to dissociate in a similar manner. Furthermore, in 1988, the US EPA, Office of Pesticides and Toxic Substances issued a Notice to producers, Formulators, Distributors and Registrants regarding quaternary ammonium compounds with regard to ""Clustering"" of such quaternary ammonium compounds. Prior to this, EPA had required each quat compound to be individually coded and registered as a new chemical, even when the chemical structure of individual compounds differed only slightly in alkyl distribution and chain lengths. This procedure was continued with the new generations of quats having two, three, and four chains. As a result, EPA records showed that some 211 registered technical grade active ingredient products containing varying concentrations of Quats, each coded separately on the basis of alkyl chain length and percentage carbon distribution within the chain. At this time, there are approximately eight to ten thousands (8-10,000) registered end-use formulations. However, questions were raised regarding whether the EPA could cluster or group the quats and pick one or more representative members of each cluster to be used in toxicity studies, instead of requiring separate studies on each quat. These same questions were raised when the EPA issued its March 4, 1987 Data Call-In Notice requiring all registrants of antimicrobial active ingredients to submit subchronic and chronic toxicological data to support the continued registration of their products. In response to these questions, EPA solicited information from industry, the public, academia, industry cooperative work groups, the state of California, and Canada. EPA then reviewed all of the assembled information along with the chemical structure of most of the quats. Based on the results of this review, EPA developed the following four groupings of currently registered quat compounds: Group I. The alkyl or hydroxyalkyl (straight chain) substituted Quats Group II. The non-halogenated benzyl substituted Quats (includes hydroxybenzyl, ethylbenzyl, hydroxyethybenzyl, napthylmethyl, dodecylbenzyl, and alkyl benzyl) Group III. The di-and tri-chlorobenzyl substituted Group IV. Quats with unusual substituents (charged heterocyclic ammonium compounds). Fundamental to this discussion EPA determined that ""X-"" in all of these structures would be attributed to ""any anionic species"". Therefore, this would mean in terms of toxicological evaluation the coutner anion in such quaternary ammonium compounds could be regarded as; e.g  halogen (Cl-, Br-, I-,), saccharinate or cyclohexylsulphamate. It is therefore suggested here that nitrite (NO2-) could also be regarded as a pertinent anion. Since the US EPA deem that such a clustering of structures for toxicological evaluation is well founded then it would seem that to consider read-across data from quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides to the closely structurally analogous quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites to be equally justifiable. Similarly since the US EPA deem that the counter anion could be regarded as ""any anionic species"" then it would seem that to consider available toxicological data on sodium nitrite, in order to evaluate any health effects that may be incurred from exposure to the nitrite anion (NO2-), is equally justifiable. Furthermore, in certain organic solvents it has been reported that the exchange constants between nitrite and chloride in quaternary ammonium salts (QAS) are approximately equal. [Zhurnal Analiticheskoi Khimii, 2010, Vol. 65, No. 6, pp. 579–584. (E.M. Rakhman’ko, M.S. Markovskaya, L.S. Stanishevskii, Yu.S. Zubenko, A.R. Tsyganov)] To that end one study is presented from quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides, CAS Number 68391-05-9, EC Number 269-924-1 and five studies are presented from sodium nitrite, CAS Number 7632-00-0, EC Number 231-555-9. Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides, CAS Number 68391-05-9, EC Number 269-924-1 A study was conducted to evaluate the toxic effects of 13 wk dietary exposure to test material (40% didecyldimethylammonium chloride (DDAC) in water) in rats. The study was conducted according to OECD guideline 408. The study was assigned a reliability score of 1 in accordance with the criteria for assessing data quality set forth by Klimisch et al. (1997). The test material was given by dietary admixture toSprague-Dawleyrats for 13 wk at the concentration of 1500, 3000 or 6000 ppm (corresponding to 42, 84 or 175 mg of DDAC/kg/d for the males and 49, 96 or 201 mg of DDAC/kg/d for the females). All animals were monitored for toxic effects including clinical observations, body and organ weights, hematology, serum chemistry, macroscopic and microscopic evaluations. Under the test conditions, the NOAEL of the test material was determined to be 1500 ppm (corresponding to 42 mg DDAC/kg/d for the males and 49 mg DDAC/kg/d for the females) in rats Sodium nitrite, CAS Number 7632-00-0, EC Number 231-555-9 (1) In a publication entitiled ""Epidemiological and Toxicological Aspects of Nitrates and Nitrites in the Environment"" [Shuval HI and Gruener N (1972); Am. J. Public Health 62, 1045-1052) a 2 year study repeat dose (oral) toxicity is reported on sodium nitrite as the primary source. Under the conditions of this study the NOEL was determined to be 6.7 mg NO2/kg bw/day. Sodium nitrite, CAS Number 7632-00-0, EC Number 231-555-9 (2) In a NTP study (2001), as a primary source, groups of male and female F344/N rats (10 animals/sex/group) were exposed to 0, 375, 750, 1,500, 3,000, or 5,000 ppm sodium nitrite (equivalent to average daily doses of approximately 0, 30, 55, 115, 200, or 310 mg sodium nitrite/kg bw/day in males and 0, 40, 80, 130, 225, or 345 mg/kg bw/day in females) in drinking water for 14 weeks. Under the conditions of the study theNOAELs were not determined although all animals showed methaemoglobin formation. However, the LOAEL were determined to be : Males = 115 mg/kg bw/day Females = 225 mg/kg bw/day Sodium nitrite, CAS Number 7632-00-0, EC Number 231-555-9 (3) In a NTP study (2001), as a primary source, groups of male and female B6C3F1 mice (10 animals/sex/group) were exposed to 0, 375, 750, 1,500, 3,000, or 5,000 ppm sodium nitrite (equivalent to average daily doses of approximately 0, 90, 190, 345, 750, or 990 mg/kg  mg sodium nitrite/kg bw/day in males and 0, 120, 240, 445, 840, or 1,230  mg/kg bw/day in females) in drinking water for 14 weeks. Under the conditions of the study the LOAEL were determined to be : Males = 750 mg/kg bw/day Females = 445 mg/kg bw/day Sodium nitrite, CAS Number 7632-00-0, EC Number 231-555-9 (4) In a NTP study (2001), as a primary source, groups of male and female F344 rats (10 animals/sex/group) were exposed to 0, 750, 1,500, 3,000 ppm sodium nitrite in drinking water (equivalent to average daily doses of approximately 0, 35, 70 or 130 mg sodium nitrite/kg bw/day in males and 0, 40, 80 or 150 mg/kg bw/day in females) in drinking water for 2 years. Under the conditions of the study theNOAEL were determined to be : Males = 130 mg/kg bw/day Females = 150 mg/kg bw/day Sodium nitrite, CAS Number 7632-00-0, EC Number 231-555-9 (5) In a NTP study (2001), as a primary source, groups of male and female B6C3F1 mice (10 animals/sex/group) were exposed to 0, 750, 1500 or 3000 ppm sodium nitrite (equivalent to average daily doses of approximately 0, 60, 120 or 220 mg/kg bw/day for males and 0, 45, 90 or 165 mg/kg bw/day for females) in drinking water for 2 years. Under the conditions of the study theNOAEL were determined to be : Males = 220 mg/kg bw/day Females = 165 mg/kg bw/day Therefore from the figures available the lowest NOEL/NOAEL to be considered are :- 42 mg/kg bw/d for quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides, CAS Number 68391-05-9, EC Number 269-924-1 and 6.7 mg/kg bw/d for sodium nitrite, CAS Number 7632-00-0, EC Number 231-555-9. It should be acknowledged that this value for sodium nitrite is a factor of ca. 20 to 30 times lower than the NOAEL derived from the other studies reported. Furthermore the 38th series of ""Reports of the Scientific Committee for Food (1997) as regards ""nitrites"" states the following :- The effects of continuous administration of nitrite to experimental animals in drinking water include vasodilation and sedation, methaemoglobinaemia and histopathological changes in cardiac muscle, lung, liver, spleen, kidney and adrenals. Hypertrophy of the adrenal zona glomerulosa is the most sensitive indicator in the rat and since the previous review additional studies have been conducted to clarify the possible role of the potassium ion and to establish a clear NOEL (TiL et al. 1990; Til & Kuper, 1995). In the most sensitive strain of Wistar rat,no significant changes were observed at doses of 10 mg KNO2 /kg b.w. while in a different Wistar strain adrenal changes were only seen at three times higher doses. Similar effects were seen with NaNO2 but with reduced incidence and severity. The mechanism by which nitrite affects the adrenal remains unclear but it has been suggested that it is related to the appearance of methaernoglobinaemia and subsequent adaptation, possibly due to competition for NADPH between methaemoglobin reductase and hydroxylases involved in corticosteroid synthesis (Boink et al.1995). Together with effects of nitrite on urinary steroids (Violanthe et. al. 1973) this suggests an adaptive change with time and explains why adrenal effects were not observed in lons-term studies. However, given that the ""nitrite"" functionality present in quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites accounts for only approximately 8.7% of the substance and the ""quaternary ammonium compounds, di-C12 -18 -alkyldimethyl fragment"" accounts for approximately 91.3% of the substance, it is envisaged that in order for 6.7 mg to be released per day then ca. 70 - 75 mg per day of quaternary ammonium compounds, di-C12 -18 -alkyldimethyl fragment would need to be released which far exceeds its NOEL of 42 mg/kg bw/d. It is therefore concluded that the NOEL for quaternary ammonium compounds, di-C12 -18 -alkyldimethyl, nitrites should be regarded as 42 mg/kg bw/d. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85e94c71-d20d-46e6-b333-38dd836b497a/documents/42830f73-de86-4656-83ac-60296521cc88_7146bf18-0020-47d1-ab7c-a6bd0415103b.html,,,,,, "Quaternary ammonium compounds, dicoco alkyldimethyl, nitrites",71487-01-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85e94c71-d20d-46e6-b333-38dd836b497a/documents/42830f73-de86-4656-83ac-60296521cc88_7146bf18-0020-47d1-ab7c-a6bd0415103b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,42 mg/kg bw/day,,rat "Quaternary ammonium compounds, dicoco alkyldimethyl, nitrites",71487-01-9," Read across data is presented on the ""fragments"" from which this substance is manufactured :- Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides, CAS Number 68391-05-9, EC Number 269-924-1 and from sodium nitrite, CAS Number 7632-00-0, EC Number 231-555-9. The justification in taking this approach is as follows :- In the stomach the gastic juice is acidic, made up of acids and enzymes. In such an evironment it is highly unlikely that the quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites substance (s) will remain ionically bound to each other and thus are prone to dissociation in which case the released cation(s) will associate with other anions and the released anion will associate with cations. Thererfore, it is suggested read-across data from the corresponding quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides is considered approriate in that such substances are likely to dissociate in a similar manner. Furthermore, in 1988, the US EPA, Office of Pesticides and Toxic Substances issued a Notice to producers, Formulators, Distributors and Registrants regarding quaternary ammonium compounds with regard to ""Clustering"" of such quaternary ammonium compounds. Prior to this, EPA had required each quat compound to be individually coded and registered as a new chemical, even when the chemical structure of individual compounds differed only slightly in alkyl distribution and chain lengths. This procedure was continued with the new generations of quats having two, three, and four chains. As a result, EPA records showed that some 211 registered technical grade active ingredient products containing varying concentrations of Quats, each coded separately on the basis of alkyl chain length and percentage carbon distribution within the chain. At this time, there are approximately eight to ten thousands (8-10,000) registered end-use formulations. However, questions were raised regarding whether the EPA could cluster or group the quats and pick one or more representative members of each cluster to be used in toxicity studies, instead of requiring separate studies on each quat. These same questions were raised when the EPA issued its March 4, 1987 Data Call-In Notice requiring all registrants of antimicrobial active ingredients to submit subchronic and chronic toxicological data to support the continued registration of their products. In response to these questions, EPA solicited information from industry, the public, academia, industry cooperative work groups, the state of California, and Canada. EPA then reviewed all of the assembled information along with the chemical structure of most of the quats. Based on the results of this review, EPA developed the following four groupings of currently registered quat compounds: Group I. The alkyl or hydroxyalkyl (straight chain) substituted Quats Group II. The non-halogenated benzyl substituted Quats (includes hydroxybenzyl, ethylbenzyl, hydroxyethybenzyl, napthylmethyl, dodecylbenzyl, and alkyl benzyl) Group III. The di-and tri-chlorobenzyl substituted Group IV. Quats with unusual substituents (charged heterocyclic ammonium compounds). Fundamental to this discussion EPA determined that ""X-"" in all of these structures would be attributed to ""any anionic species"". Therefore, this would mean in terms of toxicological evaluation the coutner anion in such quaternary ammonium compounds could be regarded as; e.g  halogen (Cl-, Br-, I-,), saccharinate or cyclohexylsulphamate. It is therefore suggested here that nitrite (NO2-) could also be regarded as a pertinent anion. Since the US EPA deem that such a clustering of structures for toxicological evaluation is well founded then it would seem that to consider read-across data from quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides to the closely structurally analogous quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites to be equally justifiable. Similarly since the US EPA deem that the counter anion could be regarded as ""any anionic species"" then it would seem that to consider available toxicological data on sodium nitrite, in order to evaluate any health effects that may be incurred from exposure to the nitrite anion (NO2-), is equally justifiable. Furthermore, in certain organic solvents it has been reported that the exchange constants between nitrite and chloride in quaternary ammonium salts (QAS) are approximately equal. [Zhurnal Analiticheskoi Khimii, 2010, Vol. 65, No. 6, pp. 579–584. (E.M. Rakhman’ko, M.S. Markovskaya, L.S. Stanishevskii, Yu.S. Zubenko, A.R. Tsyganov)] To that end one study is reported for Quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides, CAS Number 68391-05-9, EC Number 269-924 -, where the LD50 (oral) was determined to be 960 (630 to 1470) mg/kg bw and two studies are reported for sodium nitrite where the respective LD50s (oral) were deternined to be 214 mg/kg (males) and 216 mg/kg (females) in the first study and 180 mg/kg bw (males) in the second study. Sodium nitrite has a lower LD50 in both studies, resulting in an acute oral toxicity, category 3, whereas that for quaternary ammonium compounds, di-C12-18-alkyldimethyl, chlorides is an acute oral toxicity, Category 4. However, the ""nitrite"" functionality present in quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites accounts for only approximately 7% of the substance and the ""quaternary ammonium compounds, di-C12 -18 -alkyldimethyl fragment"" accounts for approximately 93% of the substance. It is therefore envisaged that the contribution to the acute oral toxicity outcome will come overwhelmingly from the ""quaternary ammonium compounds, di-C12 -18 -alkyldimethyl fragment"". The LD50 (oral) for quaternary ammonium compounds, di-C12-18-alkyldimethyl, nitrites is estimated to be ca. 699 mg/kg bw resulting in an acute oral toxicity Category 4. (In addition, NICNAS have also conducted a Human Health Tier II Assessment for sodium nitrite In this assessment the LD50 (oral) is stated to be : - 85 mg/kg bw in rats, 175–216 mg/kg bw in mice, and 186 mg/kg bw in rabbits) In addition, the acute inhalation toxicity of the test substance (containing cocobenzyldimethylammoniumchloride - 40% w/v, dicocodimethylammoniumchloride - 37.5 % w/v and water - 7.7 %) was investigated in a study conducted according to OECD guideline 403 and EPA-Guideline 81 -3 in compliance with GLP. Four groups of ten rats each (five males and five females) were given a single, 4 h whole body exposure at concentration levels of 0, 0.17, 0.24 and 0.34 mg/L. The animals were observed for 21 d after the day of exposure and were then killed for gross and histopathological examination of the lungs. Body weight, food and water intake and lung weight were also determined. There were no deaths in the control group; one animal (male) died at 0.17 mg/L, four animals died at 0.24 mg/L (3 males, 1 female), and nine animals died at 0.34 mg/L (5 males, 4 females). Clinical signs of toxicity noted were (partial) closing of the eyes and exaggerated respiratory movement during exposure in all test groups and gasping and wetness around the mouth during exposure at 0.34 mg/L. Clinical signs were noted in survivors throughout the 21 d observation period. Decrease of body weight, reduced body weight gain and reduced food and water intake was generally seen up to 14 d. Abnormalities noted at necropsy in survivors were increased relative lung weight, swollen appearance of the lungs and gas-filled stomach and intestines. Animals that died showed congestion of the lungs, fluid in the trachea and gas-filled stomachs. Histopathological lung changes in survivors generally consisted of focal alveolitis and bronchiolitis; changes in deceased animals generally consisted of focal alveolar wall necrosis, diffuse congestion, focal alveolar wall oedema and focal alveolar wall haemorrhage. Under the test conditions, the acute 4 h LC50 of the test material (containing cocobenzyldimethylammoniumchloride- 40% w/v, dicocodimethylammoniumchloride-37.5 % w/v and water 7.7 %) was found to be 0.25 mg/L (0.22 -0.28 mg/L) and it is classified as Category 2 according to CLP Regulation (EC 1272/2008). Furthermore, a study performed was performed according to GLP and OECD 402 and EU B.3 “Acute Dermal Toxicity” to investigate the dermal toxicity of didecyldimethylammonium chloride, CAS Number 7173 -51 -5, EC Number 230 -525 -2. Five male and five female rats received a dermal dose of 2000 mg/kg bw for 24 h (dose volume: 10 ml/kg in distilled water) under occlusive dressing for 24 h. One day before exposure (day -1) an area of approximately 5x7 cm on the back of the animal was clipped. 24 h, after which dressings were removed and residual test substance removed using a tissue moistened with tap water. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice on day 15. No mortality occurred. Effects noted were lethargy in all animals between day 2 and 4 and skin effects which consisted of swelling, redness, erythema and necrosis of the skin. The majority of the skin effects persisted until the end of the observation time. No abnormalities were found at macroscopic post mortem examination. Effects are limited to local irritation/corrosion of the skin, without involvement of systemic toxicity. The acute dermal LD50 of the test substance in rats were determined to be >2000 mg/kg bw (i.e. >1000 mg a.i./kg bw). As quaternary ammonium compounds do not easily pass biological membranes, dermal absorption of these compounds is very limited. The dermal toxicity of aqueous DDAC solutions is related to its corrosivety and therefore more related to the concentration of the administered solution than of the actual amount in mg/kg. Due to the direct corrosive effect, there is danger of irreversible damage to the skin upon exposure to the undiluted solution. Further toxicity is secondary to the local tissue damage, rather than the result of percutaneously absorbed material. Some reviews mention comparable dermal LD50data in rat from literature which is in the range 2000 – 3000 mg/kg bw. Toxicity is related to concentration dependent cytotoxicity, with a lack of specific systemic toxicity. The toxicity (and efficacy as based on same mechanism of action) show a dependence on chain length, with an optimum at C10-C12. Therefore this test using C10-chainlength can be seen as worst case representative for the whole group of DDAC compounds between C8and C18. Furthermore, additional tests for acute dermal toxicity are not ethical due to its corrosive effects and can thus not be performed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85e94c71-d20d-46e6-b333-38dd836b497a/documents/d4f46451-9331-4c5b-a383-d65693a2502d_7146bf18-0020-47d1-ab7c-a6bd0415103b.html,,,,,, "Quaternary ammonium compounds, dicoco alkyldimethyl, nitrites",71487-01-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85e94c71-d20d-46e6-b333-38dd836b497a/documents/d4f46451-9331-4c5b-a383-d65693a2502d_7146bf18-0020-47d1-ab7c-a6bd0415103b.html,,oral,LD50,699 mg/kg bw,adverse effect observed, "Quaternary ammonium compounds, dicoco alkyldimethyl, nitrites",71487-01-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85e94c71-d20d-46e6-b333-38dd836b497a/documents/d4f46451-9331-4c5b-a383-d65693a2502d_7146bf18-0020-47d1-ab7c-a6bd0415103b.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, "Quaternary ammonium compounds, dicoco alkyldimethyl, nitrites",71487-01-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85e94c71-d20d-46e6-b333-38dd836b497a/documents/d4f46451-9331-4c5b-a383-d65693a2502d_7146bf18-0020-47d1-ab7c-a6bd0415103b.html,,inhalation,LC50,0 mg/m3,adverse effect observed, "N,N,N',N',N''-Pentamethyl-N-C16-18 (even numbered) C18 unsat.-alkyl-1,3-propanediammonium chloride",1211950-04-7,"28 day oral (OECD 407, GLP): NOAEL 30 mg/kg bw/day based on increased ALAT, reduced BW gain, changes in thymus weight, and microscopic findings in mesenteric lymph node, stomach, thymus and lung seen at 100 mg/kg bw/day.90 day oral (OECD 408, GLP): NOAEL 10 mg/kg bw/day based on histopathological findings at 30 mg/kg consisting of loss of cilia/loss of mucous and hypertrophy/hyperplasia of the epithelium in the trachea (females only), vacuolar degeneration of the epithelium of the seminal vesicles, increased severity of macrophage foci in the lungs (in one male only), lower relative reticulocyte counts and higher alanine aminotransferase activity in males. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d12aa99b-e9d6-4d4e-84a2-ddf09fb2ee9a/documents/IUC5-3af898d4-0d81-49d1-b1ce-7cb9afb87635_6ffdd840-4f46-4f1c-9dee-411c18766ed0.html,,,,,, "N,N,N',N',N''-Pentamethyl-N-C16-18 (even numbered) C18 unsat.-alkyl-1,3-propanediammonium chloride",1211950-04-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d12aa99b-e9d6-4d4e-84a2-ddf09fb2ee9a/documents/IUC5-3af898d4-0d81-49d1-b1ce-7cb9afb87635_6ffdd840-4f46-4f1c-9dee-411c18766ed0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "N,N,N',N',N''-Pentamethyl-N-C16-18 (even numbered) C18 unsat.-alkyl-1,3-propanediammonium chloride",1211950-04-7,"Acute toxicity, oral (OECD 401, No GLP: QA declaration): 1156 mg/kg bw. No acute dermal and inhalation toxicity studies were performed on the substance due to its corrosive properties. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d12aa99b-e9d6-4d4e-84a2-ddf09fb2ee9a/documents/IUC5-53c96af3-2650-48c6-9e63-f3b49e628c72_6ffdd840-4f46-4f1c-9dee-411c18766ed0.html,,,,,, "N,N,N',N',N''-Pentamethyl-N-C16-18 (even numbered) C18 unsat.-alkyl-1,3-propanediammonium chloride",1211950-04-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d12aa99b-e9d6-4d4e-84a2-ddf09fb2ee9a/documents/IUC5-53c96af3-2650-48c6-9e63-f3b49e628c72_6ffdd840-4f46-4f1c-9dee-411c18766ed0.html,,oral,LD50,350 mg/kg bw,adverse effect observed, "Quaternary ammonium compounds, tri-C8-10-alkylmethyl, chlorides",63393-96-4,The no observed adverse effect level (NOAEL) for general systemic toxicity was 300 ppm for male (about 17 mg/kg bw/d) and female Wistar rats (about 23 mg/kg bw/d) in an OECD 422 study. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32b8f7a4-573e-4158-8fb4-2bce5a41a69d/documents/3bd51fd5-b7b3-4dff-afd2-ef614b65263e_b9b36084-6231-45ee-bb4f-633c05d3dccc.html,,,,,, "Quaternary ammonium compounds, tri-C8-10-alkylmethyl, chlorides",63393-96-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32b8f7a4-573e-4158-8fb4-2bce5a41a69d/documents/3bd51fd5-b7b3-4dff-afd2-ef614b65263e_b9b36084-6231-45ee-bb4f-633c05d3dccc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat "Quaternary ammonium compounds, tri-C8-10-alkylmethyl, chlorides",63393-96-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32b8f7a4-573e-4158-8fb4-2bce5a41a69d/documents/0335b1ca-8704-4816-83f8-ce2b08320024_b9b36084-6231-45ee-bb4f-633c05d3dccc.html,,oral,discriminating dose,200 mg/kg bw,adverse effect observed, Quinidine,56-54-2,The LD50 of quinidine for rats after oral application is 263 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76b96084-fd5a-4c20-b18a-e6126438470b/documents/IUC5-8d7da3f3-2c2f-4da0-bf42-41179444260e_e7fad9e8-4a3f-4086-a346-88de9af6a169.html,,,,,, Quinidine,56-54-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76b96084-fd5a-4c20-b18a-e6126438470b/documents/IUC5-8d7da3f3-2c2f-4da0-bf42-41179444260e_e7fad9e8-4a3f-4086-a346-88de9af6a169.html,,oral,LD50,236 mg/kg bw,adverse effect observed, Quinine dihydrochloride,60-93-5,The LD50 of quinine dihydrochloride of rats after oral application is 1392 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2a226bf-db45-41a1-9f28-3857f6bc75ea/documents/IUC5-fae15821-5287-41bb-a97a-3b0c9b6b53e1_2cd2562b-7cde-4f37-9dd0-839d7259e21f.html,,,,,, Quinine dihydrochloride,60-93-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a2a226bf-db45-41a1-9f28-3857f6bc75ea/documents/IUC5-fae15821-5287-41bb-a97a-3b0c9b6b53e1_2cd2562b-7cde-4f37-9dd0-839d7259e21f.html,,oral,LD50,"1,392 mg/kg bw",adverse effect observed, "Quino[2,3-b]acridine-6,7,13,14(5H,12H)-tetrone",1503-48-6,No mortality and no significant clinical signs were observed in female rats treated with the limit dose of 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30b79eb4-3f4e-4608-baff-ddcf92dc3571/documents/IUC5-f3d42841-b758-4113-9e11-4da539148d43_9d97e74a-bbf3-41dc-b732-dad1497b9a46.html,,,,,, "Quino[2,3-b]acridine-6,7,13,14(5H,12H)-tetrone",1503-48-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30b79eb4-3f4e-4608-baff-ddcf92dc3571/documents/IUC5-f3d42841-b758-4113-9e11-4da539148d43_9d97e74a-bbf3-41dc-b732-dad1497b9a46.html,,oral,discriminating dose,"2,000 mg/kg bw",, Quinuclidin-3-ol,1619-34-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4364de5-b923-4779-a65a-47de0bdad50c/documents/48b6daa2-4708-4d61-81f6-ae3f943a0cce_f50826a4-dc35-41cf-a147-4daa0014a220.html,,oral,LD50,"2,504.43 ",adverse effect observed, Quinuclidin-3-one hydrochloride,1193-65-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/35eb3ce4-2c85-4f01-a532-bd3757a84d04/documents/b289b724-8e9a-451d-a58d-2e2ac23ea321_c0d6ebe2-6eef-44d3-ae38-27cae8d88269.html,,oral,LD50,"2,399.57 mg/kg bw",adverse effect observed, "Raffinates (Fischer-Tropsch), C10-25-branched",1345668-40-7,"Repeated Dose Oral 90d – NOAEL >=5000 mg/kg for rats (similar to OECD TG 408)Repeated Dose Inhalation 90d – NOAEL >= 10400 mg/m3 for rats (similar to OECD TG 413)Repeated Dose Dermal 90d – NOAEL >=495 mg/kg for rats, highest dose tested (similar to OECD TG 410) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d0d3a01-6cb5-4693-a363-34c867ec0e5b/documents/IUC5-c11d1683-7081-4c07-8aed-5edfa6087b82_b2785300-977f-484c-a40f-a3bb182d2a67.html,,,,,, "Raffinates (Fischer-Tropsch), C10-25-branched",1345668-40-7,Acute Toxicity-Oral LD50 > 5000 mg/kg in rats (OECD TG 401)Acute Toxicity-Dermal LD50 > 5000 mg/kg in rabbits (OECD TG 402)Acute Toxicity-Inhalation LC50 > 5000 mg/m3 (OECD TG 403) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d0d3a01-6cb5-4693-a363-34c867ec0e5b/documents/IUC5-5109a432-7cf9-42a9-aefb-ebdbb88b9c3a_b2785300-977f-484c-a40f-a3bb182d2a67.html,,,,,, [6-hydroxy-2-(4-hydroxyphenyl)-1-benzothiophen-3-yl]-[4-(2-piperidin-1-ylethoxy)phenyl]methanone,84449-90-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): EDQM Safety Data Sheet - RALOXIFENE HYDROCHLORIDE, Version: 3 Revision date: 27/06/2013 (species: rat _ rel. 1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): EDQM Safety Data Sheet - RALOXIFENE HYDROCHLORIDE, Version: 3 Revision date: 27/06/2013 (species:rat_rel.1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): EDQM Safety Data Sheet - RALOXIFENE HYDROCHLORIDE, Version: 3 Revision date: 27/06/2013 (species: rabbit_ rel.1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d57605ba-1875-4b53-9fd9-8eac5c762fe7/documents/c10ad7c0-ecb1-46d1-9d4a-016e34f664e5_2f4cad72-5547-4632-b9cb-91d04219e329.html,,,,,, [6-hydroxy-2-(4-hydroxyphenyl)-1-benzothiophen-3-yl]-[4-(2-piperidin-1-ylethoxy)phenyl]methanone,84449-90-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d57605ba-1875-4b53-9fd9-8eac5c762fe7/documents/c10ad7c0-ecb1-46d1-9d4a-016e34f664e5_2f4cad72-5547-4632-b9cb-91d04219e329.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, [6-hydroxy-2-(4-hydroxyphenyl)-1-benzothiophen-3-yl]-[4-(2-piperidin-1-ylethoxy)phenyl]methanone,84449-90-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d57605ba-1875-4b53-9fd9-8eac5c762fe7/documents/c10ad7c0-ecb1-46d1-9d4a-016e34f664e5_2f4cad72-5547-4632-b9cb-91d04219e329.html,,dermal,LD50,200 mg/kg bw,adverse effect observed, [6-hydroxy-2-(4-hydroxyphenyl)-1-benzothiophen-3-yl]-[4-(2-piperidin-1-ylethoxy)phenyl]methanone,84449-90-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d57605ba-1875-4b53-9fd9-8eac5c762fe7/documents/c10ad7c0-ecb1-46d1-9d4a-016e34f664e5_2f4cad72-5547-4632-b9cb-91d04219e329.html,,inhalation,LC50,200 mg/m3,no adverse effect observed, "Rape oil, oxidized",95193-59-2, One study in accordance with OECD 422 showing no evidence of toxicity (NOAEL: >1000 mg/kg bw/day) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/02a2a909-0633-456e-ae36-8b1ddffe4126/documents/IUC5-06f924a8-254e-494f-8916-f5adf21b0573_476ae81e-e066-46e5-af84-4cbc364c067e.html,,,,,, "Rape oil, oxidized",95193-59-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/02a2a909-0633-456e-ae36-8b1ddffe4126/documents/IUC5-06f924a8-254e-494f-8916-f5adf21b0573_476ae81e-e066-46e5-af84-4cbc364c067e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Rape oil, oxidized",95193-59-2, Acute toxicity (oral): >4985 mg/kg (OECD 401) and acute toxicity (dermal): >2000 mg/kg (OECD 402) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02a2a909-0633-456e-ae36-8b1ddffe4126/documents/IUC5-1bd966f4-6d87-4bb0-812f-afb99c53baa8_476ae81e-e066-46e5-af84-4cbc364c067e.html,,,,,, "Rape oil, oxidized",95193-59-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02a2a909-0633-456e-ae36-8b1ddffe4126/documents/IUC5-1bd966f4-6d87-4bb0-812f-afb99c53baa8_476ae81e-e066-46e5-af84-4cbc364c067e.html,,oral,LD50,"4,985 mg/kg bw",no adverse effect observed, "Rape oil, oxidized",95193-59-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02a2a909-0633-456e-ae36-8b1ddffe4126/documents/IUC5-1bd966f4-6d87-4bb0-812f-afb99c53baa8_476ae81e-e066-46e5-af84-4cbc364c067e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Rape oil, reaction products with diethanolamine",68187-80-4,"A 90-d oral study conducted on structurally similar C12 DEA from which a NOAEL of 50 mg/kg bw/d was established, showed effects at higher dose levels. However it is unclear whether the effects noted were related to the test substance itself or was a result of the nutritional deficiencies due to the un-palatability of the diet (Sharrat et al., 1961). Furthermore, a 28-day oral repeated dose toxicity study conducted with structurally similar, C12-18 and C18-unsatd. DEA in rats revealed a NOAEL of >750 mg/kg bw/d based on absence of treatment-related effects at any of the tested dose levels (Potokar, 1983). Therefore it is scientifically justified to use the subacute oral rat NOAEL of 750 mg/kg bw/d to derive the oral DNEL.Regarding the dermal route, the following dose descriptors resulted from 90-d and 2-yr NTP studies on structural analogue ODEA: • Sub-chronic dermal rat: NOAEL (systemic effects): 100 mg/kg bw/d based on body weight, organ weight and clinical chemistry alterations at the ≥200 mg/kg bw/d; NOAEL (local effects): 25 mg/kg bw/d based on non-neoplastic lesions of the skin at ≥50 mg/kg bw/d. Sub-chronic dermal mouse LOAEL for systemic effects: 50 mg/kg bw/d based organ weight changes at ≥50 mg/kg bw/d; LOAEL for local effects: 50 mg/kg bw/d based on non-neoplastic lesion of the skin• Chronic dermal rat: NOAEL (systemic effects): 50 mg/kg bw/d based on BW changes at the LOAEL; LOAEL (local effects): 50 mg/kg bw/d based on non-neoplastic lesion of the skin at all tested doses. Chronic dermal mouse: NOAEL (systemic effects): 15 mg/kg bw/d based on body weight changes; LOAEL (local effects): 15 mg/kg bw/d based on non-neoplastic lesions of the skin. Giving preference to rat species as well as considering the highest NOAEL below the lowest LOAEL, the NOAEL for systemic effects of 50 mg/kg bw/d from the 2-yr study in rats will be used. For the local effects, since the 90-d and 2-yr rat studies result in LOAELs of 50 mg/kg bw/d this will be further used. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79764151-d7fe-4015-84a8-89c60a9b4c53/documents/IUC5-3eebf883-d732-4fa8-99e1-4f007bc3bbac_ad9b52c8-d149-4607-8d22-0e0dba87671b.html,,,,,, "Rape oil, reaction products with diethanolamine",68187-80-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79764151-d7fe-4015-84a8-89c60a9b4c53/documents/IUC5-3eebf883-d732-4fa8-99e1-4f007bc3bbac_ad9b52c8-d149-4607-8d22-0e0dba87671b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Rape oil, reaction products with diethanolamine",68187-80-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79764151-d7fe-4015-84a8-89c60a9b4c53/documents/IUC5-3eebf883-d732-4fa8-99e1-4f007bc3bbac_ad9b52c8-d149-4607-8d22-0e0dba87671b.html,Chronic toxicity – systemic effects,dermal,NOAEL,50 mg/kg bw/day,,rat "Rape oil, reaction products with diethanolamine",68187-80-4,"The available data suggests that HE Rape Oil, reaction product with diethanolamine has a low potential for acute oral toxicity (i.e., LD50 >10,000 mg/kg bw) based on a study conducted with the read across substance C18-unsatd. DEA and dermal toxicity (i.e., LD50 >2,000 mg/kg bw) based on read across study conducted with C8-18 and C18-unsatd. DEA. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79764151-d7fe-4015-84a8-89c60a9b4c53/documents/IUC5-5ee4753e-016e-484c-84a1-034da1a46160_ad9b52c8-d149-4607-8d22-0e0dba87671b.html,,,,,, "Rape oil, reaction products with diethanolamine",68187-80-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79764151-d7fe-4015-84a8-89c60a9b4c53/documents/IUC5-5ee4753e-016e-484c-84a1-034da1a46160_ad9b52c8-d149-4607-8d22-0e0dba87671b.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Rape oil, reaction products with diethanolamine",68187-80-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79764151-d7fe-4015-84a8-89c60a9b4c53/documents/IUC5-5ee4753e-016e-484c-84a1-034da1a46160_ad9b52c8-d149-4607-8d22-0e0dba87671b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Rape oil, reaction products with diethylenetriamine",91081-13-9," Short-term repeated dose oral toxicity: Treatment at dosages of up to 1000 mg/kg bw/day for 28-days was well tolerated and the No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be 1000 mg/kg bw/day (OECD 422).   Sub-chronic repeated dose toxicity: Daily repeated administration of test item to rats by oral gavage for 90 days at doses of 300, 600 or 1000 mg/kg/day, followed by a 4-week recovery period was well tolerated and did not result in any adverse effects of treatment. There were no treatment-related macroscopic or microscopic changes. Slight disturbances were observed in some hematological and blood chemistry parameters and there was a slight increase in uterus and cervix weights however these were minor in degree, generally recovered fully and were not associated with any microscopic pathology correlates. The no-observed-adverse-effect-level (NOAEL) in this study was therefore considered to be 1000 mg/kg/day and the no-observed-effect-level (NOEL) was considered to be 300 mg/kg/day (OECD 408). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d1a2f654-dd64-4302-8d4c-4eea810c6f50/documents/ee55282b-ef9a-492d-a2b1-cbe26760833a_96de8c4d-7879-4bac-9a07-31efd6b78e7e.html,,,,,, "Rape oil, reaction products with diethylenetriamine",91081-13-9, Oral route: The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was considered to be > 2000 mg/kg body weight (OECD 420 and EU Method B.1 bis). Dermal route: The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be > 2000 mg/kg body weight (OECD 402 and EU Method B.3). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1a2f654-dd64-4302-8d4c-4eea810c6f50/documents/d2ddbc18-dfaa-49aa-a266-06d9e85b17cc_96de8c4d-7879-4bac-9a07-31efd6b78e7e.html,,,,,, "Rape oil, reaction products with diethylenetriamine, di-Me sulfate-quaternized",98219-63-7," Based on the results of the read across study, test substance, 'di-C16-18-satd. and C18-24-unsatd. AAEMIM-MS' is considered to be of low acute oral toxicity, with an oral LD50 value >2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ce136f5-2b80-4c73-bb73-9ab1a7fa82e5/documents/6cd58cc1-794b-4494-9d2f-8a0189d7439c_a778d63c-d3c4-4d06-b907-46b040ec42a6.html,,,,,, "Rape oil, reaction products with diethylenetriamine, di-Me sulfate-quaternized",98219-63-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ce136f5-2b80-4c73-bb73-9ab1a7fa82e5/documents/6cd58cc1-794b-4494-9d2f-8a0189d7439c_a778d63c-d3c4-4d06-b907-46b040ec42a6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Rape oil, sulfated, ammonium salt",84082-28-0,"Fish sulfated sodium salt (OECD407): NOAEL (21d, male/female) = 1000 mg/kg bw Fish sulfated sodium salt (OECD408): NOAEL (90d, male/female) = 1000 mg/kg bw Rape oil sulfated sodium salt (OECD422): NOAEL (28d, male/female) = 1000 mg/kg bw FLL Sample 3 (OECD422): NOAEL (28d, male/female) = 1000 mg/kg bw FLL Sample 4 (OECD422): NOAEL (28d, male/female) = 1000 mg/kg bw ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4855b85-b6c5-4213-a963-58a29d1d14bb/documents/bacbd5e1-fc52-45e3-8802-a88614bc9c32_a3a0b77b-ebde-4604-9e6d-de753d30c0dc.html,,,,,, "Rape oil, sulfated, ammonium salt",84082-28-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4855b85-b6c5-4213-a963-58a29d1d14bb/documents/bacbd5e1-fc52-45e3-8802-a88614bc9c32_a3a0b77b-ebde-4604-9e6d-de753d30c0dc.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Rape oil, sulfated, ammonium salt",84082-28-0,"Acute toxicity, oral: - Fish oils sulfated sodium salt (OECD423): LD50 (14d, females) > 2000 mg/kg bw - Rape oil sulfated sodium salt (OECD 423): LD50 (14d, female) > 2000 mg/kg bw - Oils, vegetable, sulfated, ammonium salts (OECD 423): LD50 (14d, female) > 2000 mg/kg bw.   Acute toxicity, dermal: - Rape oil sulfated sodium salt (OECD402): LD50 (14d, male/female) > 2000 mg/kg bw - FLL Sample 3 (OECD402): LD50 (14d, male/female) > 2000 mg/kg bw - FLL Sample 4 (OECD402): LD50 (14d, male/female) > 2000 mg/kg bw         ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4855b85-b6c5-4213-a963-58a29d1d14bb/documents/IUC5-fe335af4-6337-4dcd-ba8c-1ab5b7787a51_a3a0b77b-ebde-4604-9e6d-de753d30c0dc.html,,,,,, "Rape oil, sulfated, ammonium salt",84082-28-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4855b85-b6c5-4213-a963-58a29d1d14bb/documents/IUC5-fe335af4-6337-4dcd-ba8c-1ab5b7787a51_a3a0b77b-ebde-4604-9e6d-de753d30c0dc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Rape oil, sulfated, ammonium salt",84082-28-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4855b85-b6c5-4213-a963-58a29d1d14bb/documents/IUC5-fe335af4-6337-4dcd-ba8c-1ab5b7787a51_a3a0b77b-ebde-4604-9e6d-de753d30c0dc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Rape oil, sulfated, sodium salt",84082-30-4,Sub-acute toxicity: NOAEL - Males and females: 1000 mg/kg/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8de5fb58-25e9-4545-a4eb-fec3e031b433/documents/IUC5-3662f5a6-53b4-4ed3-b325-3d36b57017a6_0ec4dbae-f939-4f07-bb8e-78726484a2ed.html,,,,,, "Rape oil, sulfated, sodium salt",84082-30-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8de5fb58-25e9-4545-a4eb-fec3e031b433/documents/IUC5-3662f5a6-53b4-4ed3-b325-3d36b57017a6_0ec4dbae-f939-4f07-bb8e-78726484a2ed.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Rape oil, sulfated, sodium salt",84082-30-4,- Acute toxicity:Oral: LD50: >2000 mg/kg in the ratDermal: LD50: > 2000 mg/kg in the rat ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8de5fb58-25e9-4545-a4eb-fec3e031b433/documents/IUC5-0ea96eca-f07b-403b-b43a-cdf6757c7abd_0ec4dbae-f939-4f07-bb8e-78726484a2ed.html,,,,,, "Rape oil, sulfated, sodium salt",84082-30-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8de5fb58-25e9-4545-a4eb-fec3e031b433/documents/IUC5-0ea96eca-f07b-403b-b43a-cdf6757c7abd_0ec4dbae-f939-4f07-bb8e-78726484a2ed.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Rape oil, sulfated, sodium salt",84082-30-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8de5fb58-25e9-4545-a4eb-fec3e031b433/documents/IUC5-0ea96eca-f07b-403b-b43a-cdf6757c7abd_0ec4dbae-f939-4f07-bb8e-78726484a2ed.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Reaction mass of (3R)-3-[(1R)-4-methyl-3-cyclohexen-1-yl]butanal and (3S)-3-[(1R)-4-methyl-3-cyclohexen-1-yl]butanal,199445-85-7," Oral: LD50> 2000 mg/kg bw, male and female rat, OECD 401, Anon, 1991. Dermal: LD50> 2000 mg/kg bw, male and female rat, OECD 402, Anon, 1991. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a046b5c4-cc12-4dd4-93ef-e17c77dcf9d3/documents/625a0a79-83ae-4d50-89a6-4c185bc54327_9817ee88-38f6-49e5-ac23-92a2009118ea.html,,,,,, "Reaction mass of 1,4-bis(methoxymethyl)benzene, 1,6-dihydroxynaphtalene and Epichlorohydrin",577978-76-8," Acute Oral: Under the conditions of this study, the acute oral LD50 value of the test item CAS 577978-76-8 was found to be greater than 2000 mg/kg bw in female Crl:WI rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70867a10-648c-4c7f-bb25-4ec41b6b8116/documents/7a3df347-b937-4cbd-bee2-0ee15f7af315_6c4941de-616a-44c5-8899-75b01d667dd6.html,,,,,, "Reaction mass of 1,4-bis(methoxymethyl)benzene, 1,6-dihydroxynaphtalene and Epichlorohydrin",577978-76-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70867a10-648c-4c7f-bb25-4ec41b6b8116/documents/7a3df347-b937-4cbd-bee2-0ee15f7af315_6c4941de-616a-44c5-8899-75b01d667dd6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction mass of 1,4-bis[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and 1-(butylamino)-4-[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and 1-[(2-ethylhexyl)amino]-4-(methylamino)-9,10-dihydroanthracene-9,10-dione",64553-79-3," Read Across approach used to analogue substance. Assumption that target substance will have the same properties. Available data for the source substance Solvent Blue 98: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, oral (gavage), rat , M/F, OECD guideline 422, GLP ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc1484fa-0d34-434a-a872-1b6591712b95/documents/8d75b57a-175e-4dec-808c-7d65581440e7_2d96d3d6-1f94-4054-b96b-422745b79157.html,,,,,, "Reaction mass of 1,4-bis[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and 1-(butylamino)-4-[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and 1-[(2-ethylhexyl)amino]-4-(methylamino)-9,10-dihydroanthracene-9,10-dione",64553-79-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc1484fa-0d34-434a-a872-1b6591712b95/documents/8d75b57a-175e-4dec-808c-7d65581440e7_2d96d3d6-1f94-4054-b96b-422745b79157.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat "Reaction mass of 1,4-bis[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and 1-(butylamino)-4-[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and 1-[(2-ethylhexyl)amino]-4-(methylamino)-9,10-dihydroanthracene-9,10-dione",64553-79-3," Acute oral toxicity: LD50 > 2000 mg/kg bw, EU Method B.1 tris, OECD 423, GLP compliant ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc1484fa-0d34-434a-a872-1b6591712b95/documents/26acefb2-551f-41e4-aba9-d3218a20b92f_2d96d3d6-1f94-4054-b96b-422745b79157.html,,,,,, "Reaction mass of 1,4-bis[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and 1-(butylamino)-4-[(2-ethylhexyl)amino]-9,10-dihydroanthracene-9,10-dione and 1-[(2-ethylhexyl)amino]-4-(methylamino)-9,10-dihydroanthracene-9,10-dione",64553-79-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc1484fa-0d34-434a-a872-1b6591712b95/documents/26acefb2-551f-41e4-aba9-d3218a20b92f_2d96d3d6-1f94-4054-b96b-422745b79157.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction mass of 1,5-dihydroxy-4,8-dinitroanthraquinone and 1,8-dihydroxy-4,5-dinitroanthraquinone",51505-88-5, No acute toxicity expected ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/277ae23a-c128-449d-b5be-17048e8a0067/documents/7e901412-6a90-4357-9cae-100ef31240be_2c1b8387-9da1-4f09-a6f8-6cd9e03b4900.html,,,,,, "2,2,4-trimethylhexane-1,6-diol; 2,4,4-trimethylhexane-1,6-diol",35255-57-3," In a dose-range-finding study, the test item was administered by oral gavage to Wistar rats for 7 consecutive days at dose levels of 100, 300 and 1000 mg/kg bw/day in propylene glycol at a dose volume of 4 mL/kg bw (CitoxLab, 2015). There were no adverse effects observed which could clearly be related to test item administration. Therefore, based on the observation of this DRF study, the dose levels for the main study were 0, 100, 300 and 1000 mg/kg bw/day. In the repeated dose oral toxicity study according to OECD 422 with Wistar rats exposed to 100, 300 and 1000 mg/kg bw/day, the test item caused some mortality in the adults at 1000 mg/kg/day. Minor changes in the liver in the Mid and High dose groups of the parental generation, as well as changes in kidneys in the High dose group were not considered to be adverse. It is considered that the no observed adverse effect levels (NOAEL) in this study for the parental/adult is 300 mg/kg bw/day under the current test conditions. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ebc923f-8403-4145-8bf9-3a4cd2f7c12e/documents/205d6334-484f-4695-a57c-4ed1794576ef_b09edde2-1c21-483b-ba43-aa2c2d34e9fd.html,,,,,, "2,2,4-trimethylhexane-1,6-diol; 2,4,4-trimethylhexane-1,6-diol",35255-57-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ebc923f-8403-4145-8bf9-3a4cd2f7c12e/documents/205d6334-484f-4695-a57c-4ed1794576ef_b09edde2-1c21-483b-ba43-aa2c2d34e9fd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "2,2,4-trimethylhexane-1,6-diol; 2,4,4-trimethylhexane-1,6-diol",35255-57-3,"Under the conditions of the study in rats according to OECD 401 the acute toxicity after oral application is greater than 2000 mg/kg bw for the test item (Hüls AG, 1996). Furthermore an acute dermal toxicity study was conducted in rats according to OECD 402 revealed LD50 of greater than 2000 mg/kg bw (Hüls AG, 1996). An inhalation acute toxicity study is not available for the test substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is a guideline study with Klimisch score 1 (reliable without restrictions). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study is a guideline study with Klimisch score 1 (reliable without restrictions). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ebc923f-8403-4145-8bf9-3a4cd2f7c12e/documents/2d0f1406-5e55-444f-a975-42406d1d9140_b09edde2-1c21-483b-ba43-aa2c2d34e9fd.html,,,,,, "2,2,4-trimethylhexane-1,6-diol; 2,4,4-trimethylhexane-1,6-diol",35255-57-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ebc923f-8403-4145-8bf9-3a4cd2f7c12e/documents/2d0f1406-5e55-444f-a975-42406d1d9140_b09edde2-1c21-483b-ba43-aa2c2d34e9fd.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "2,2,4-trimethylhexane-1,6-diol; 2,4,4-trimethylhexane-1,6-diol",35255-57-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ebc923f-8403-4145-8bf9-3a4cd2f7c12e/documents/2d0f1406-5e55-444f-a975-42406d1d9140_b09edde2-1c21-483b-ba43-aa2c2d34e9fd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Reaction mass of 2-ethyl-4-methyl-1H-imidazole-1-propiononitrile and 2-ethyl-5-methyl-1H-imidazole-1-propiononitrile,568591-00-4,"Key information: OECD TG407; 28 day repeated dose toxicity; Hoshuyama al. 2018   An OECD TG 407 study was conducted in order to examine the test substances' potential to toxicity following a sub-acute oral dosing regime. The results indicated treatment-related adverse effects in the liver, with secondary effects on the thyroid, and a potential effect on the nervous system. A NOAEL of 50 mg/kg bw/day was established.   The CLP guidance value range for STOT RE classification into category 1 is ≤ 30mg/kg and category 2 is ≤ 300mg/kg bw/day. Effects considered to be adverse and related to the test substance were reported at doses of 150mg/kg bw/day and above, therefore the effects are within the value range for its classification as STOT RE Category 2 (liver, thyroid). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): This endpoint was composed of one quality study with a Klimish score of 1 performed in accordance with OECD TG 407 and GLP. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8fb9779-f9ee-4bca-ae79-c5b8e40229f3/documents/94bf035c-c259-4389-ab0a-6e760f5d1bb4_6e225972-8cea-4a26-b075-c744a0c6bd9a.html,,,,,, Reaction mass of 2-ethyl-4-methyl-1H-imidazole-1-propiononitrile and 2-ethyl-5-methyl-1H-imidazole-1-propiononitrile,568591-00-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8fb9779-f9ee-4bca-ae79-c5b8e40229f3/documents/94bf035c-c259-4389-ab0a-6e760f5d1bb4_6e225972-8cea-4a26-b075-c744a0c6bd9a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Reaction mass of 2-hydroxy-1,3-propanediyl bismethacrylate and 101525-90-0",28497-59-8," No data are available for GDMA. However, data from the metabolites (HPMA as analogous substance of the primary metabolites plus MAA/MMA and glycerol) allow the evaluation of repeated dose hazard of GDMA after oral and inhalative exposure. Read-across to the metabolites is justified by the fact that carboxylesterases are ubiquitous in the body and half-lifes of the other category substances are only a few minutes (see category document, chapter 5.1). In the body, methyl methacrylate hydrolyses rapidly to methacrylic acid and thus serves as methacrylic acid donor in several test systems investigating systemic effects.   Following data were considered for read across: Subacute (33-40 day) study; oral (gavage); rat, m/f (OECD guideline 422, GLP): NOAEL = 300 mg/kg bw/d due to mortality and clinical findings; read-across from the analogous substance of the primary metabolites, HPMA (Nihon Bioresearch 1996) Chronic (2 yrs) study; oral (drinking water), rat, m/f (pre-guideline, pre-GLP): NOAEL ≥ 2000 ppm (=124 mg/kg bw/d in males and 164 mg/kg bw/d in females); read-across from the metabolite donor substance MMA (Borzelleca 1964) Chronic/ Carcinogenicity (2 yrs) study; inhalation (vapour), rat, m/f (comp. to OECD guideline 453, non-GLP): LOAEClocal= 100 ppm (ca. 416 mg/m3) due to nasal lesions; NOAECsystemic= 400 ppm (ca. 1640 mg/m3) due to reduced bw gain read-across from the metabolite donor substance MMA (Lomax 1997) Chronic/ Carcinogenicity (2 yrs) study; inhalation (vapour), rat, m/f (NTP protocol, GLP): LOAEClocal= 250 ppm for female rats and 500 ppm for male rats due to nasal lesions; NOAECsystemic≥ 500 ppm for female rats and ≥ 1000 ppm male rats; read-across from the metabolite donor substance MMA (NTP 1986) Chronic (2 yrs) study; oral (feed), rat, m/f (pre-guideline, non-GLP); NOAEL = 5000 mg/kg bw/d; read across from the alcohol metabolite Glycerol (Hine 1953) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b3f9ce7-6109-4678-a053-4b7504b9bcef/documents/88356a88-2fb4-4ea7-a7cb-f3cde51bd588_5181cdf4-ecc8-43c7-832a-0b875de50e50.html,,,,,, "Reaction mass of 2-hydroxy-1,3-propanediyl bismethacrylate and 101525-90-0",28497-59-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b3f9ce7-6109-4678-a053-4b7504b9bcef/documents/88356a88-2fb4-4ea7-a7cb-f3cde51bd588_5181cdf4-ecc8-43c7-832a-0b875de50e50.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Reaction mass of 2-hydroxy-1,3-propanediyl bismethacrylate and 101525-90-0",28497-59-8,"Glycerol dimethacrylate is of low acute oral toxicity. LD50 is higher than 2000 mg/kg bw in rats. Acute oral toxicity: LD50 (rat, combined) > 2000 mg/kg bw; OECD Guideline 423, GLP (Klimisch score = 1)Acute inhalation toxicity: no relevant route of exposureAcute dermal toxicity: no adverse effects/ very low systemic toxicity after oral exposure as relevant route of exposure ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b3f9ce7-6109-4678-a053-4b7504b9bcef/documents/c8777db8-dcb3-416c-a837-b4c56a00bbbd_5181cdf4-ecc8-43c7-832a-0b875de50e50.html,,,,,, "Reaction mass of 2-hydroxy-1,3-propanediyl bismethacrylate and 101525-90-0",28497-59-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b3f9ce7-6109-4678-a053-4b7504b9bcef/documents/c8777db8-dcb3-416c-a837-b4c56a00bbbd_5181cdf4-ecc8-43c7-832a-0b875de50e50.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction mass of 3-(octanoyloxy)propyl decanoate and propane-1,3-diyl didecanoate and propane-1,3-diyl dioctanoate",1072005-10-7," A repeated dose toxicity study does not need to be conducted according to REACH Annex XI, 1.2, Weight of Evidence (WoE). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1b5aea9-90c6-4ba6-8f54-8ee02d90f259/documents/337d198e-9ad3-46a0-9a5b-ccbcae1fab80_d6ab7e85-ba01-4a8b-8b2e-2ccdee02bcca.html,,,,,, "Reaction mass of 3-(octanoyloxy)propyl decanoate and propane-1,3-diyl didecanoate and propane-1,3-diyl dioctanoate",1072005-10-7," No data on the test item is available. With the read-across substances the following results were obtained: Acute oral, mouse (CAS 68583-51-7): EC50 > 4600 mg/kg Acute inhalation, guinea pig (CAS 68583-51-7): LC50 > 200 ppm (equivalent to 5952 mg/m³) Acute inhalation, rat (CAS 68583-51-7): LC50 > 200 ppm (equivalent to 5952 mg/m³) Acute dermal, rat (CAS 853947-59-8): LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1b5aea9-90c6-4ba6-8f54-8ee02d90f259/documents/bf603090-c1c3-464d-b194-79f0e8484f02_d6ab7e85-ba01-4a8b-8b2e-2ccdee02bcca.html,,,,,, "Reaction mass of 3-(octanoyloxy)propyl decanoate and propane-1,3-diyl didecanoate and propane-1,3-diyl dioctanoate",1072005-10-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1b5aea9-90c6-4ba6-8f54-8ee02d90f259/documents/bf603090-c1c3-464d-b194-79f0e8484f02_d6ab7e85-ba01-4a8b-8b2e-2ccdee02bcca.html,,oral,discriminating dose,"4,600 mg/kg bw",no adverse effect observed, "Reaction mass of 3-(octanoyloxy)propyl decanoate and propane-1,3-diyl didecanoate and propane-1,3-diyl dioctanoate",1072005-10-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1b5aea9-90c6-4ba6-8f54-8ee02d90f259/documents/bf603090-c1c3-464d-b194-79f0e8484f02_d6ab7e85-ba01-4a8b-8b2e-2ccdee02bcca.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Reaction mass of 3-(octanoyloxy)propyl decanoate and propane-1,3-diyl didecanoate and propane-1,3-diyl dioctanoate",1072005-10-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1b5aea9-90c6-4ba6-8f54-8ee02d90f259/documents/bf603090-c1c3-464d-b194-79f0e8484f02_d6ab7e85-ba01-4a8b-8b2e-2ccdee02bcca.html,,inhalation,discriminating conc.,"5,952 mg/m3",no adverse effect observed, "Reaction Mass of 3,3-diphenylhexamethyltrisiloxane and 3,3,5,5-tetraphenylhexamethyltetrasiloxane",352230-22-9," In a 28-day repeated dose study, conducted according to an appropriate OECD Test Guideline and in compliance with GLP, a NOEL (no-observed-effect-level) could not be established for the submission substance, Reaction Mass of 3,3-diphenylhexamethyltrisiloxane and 3,3,5,5tetraphenylhexamethyltetrasiloxane, however, no adverse effects were seen in this study and so the NOAEL (no-observed- adverse-effect-level) was considered to be ≥ 1000 mg/kg (RCC, 2004). In a supporting study, a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test (oral route), performed according to OECD TG 422 with acceptable restrictions, and in compliance with GLP, no biologically significant, treatment-related effects were reported in rats for 1,3,5-trimethyl-1,1,3,5,5-pentaphenyltrisiloxane, a structural analogue to the submission substance. A NOAEL of ≥1000 mg/kg bw/day was determined (DCC, 2005). This study is included because it is needed for reproductive/developmental read-across. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88084c69-fe71-41a9-a3bb-d33150491350/documents/b5d8460f-5a35-49bd-9514-9586e094159a_5267264c-fe2a-4728-8657-759504e26cc9.html,,,,,, "Reaction Mass of 3,3-diphenylhexamethyltrisiloxane and 3,3,5,5-tetraphenylhexamethyltetrasiloxane",352230-22-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/88084c69-fe71-41a9-a3bb-d33150491350/documents/b5d8460f-5a35-49bd-9514-9586e094159a_5267264c-fe2a-4728-8657-759504e26cc9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Reaction Mass of 3,3-diphenylhexamethyltrisiloxane and 3,3,5,5-tetraphenylhexamethyltetrasiloxane",352230-22-9," The key acute oral toxicity study for the submission substance, conducted according to an appropriate OECD test guideline and in compliance with GLP, reported an LD50 value of greater than 2000 mg/kg bw (RCC 2004). The key acute dermal toxicity study for the submission substance, conducted according to an appropriate OECD test guideline and in compliance with GLP, reported an LD50 value of greater than 2000 mg/kg bw (RCC 2004). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88084c69-fe71-41a9-a3bb-d33150491350/documents/e7ace52a-c83c-488b-8c54-a59b62eba554_5267264c-fe2a-4728-8657-759504e26cc9.html,,,,,, "Reaction Mass of 3,3-diphenylhexamethyltrisiloxane and 3,3,5,5-tetraphenylhexamethyltetrasiloxane",352230-22-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/88084c69-fe71-41a9-a3bb-d33150491350/documents/e7ace52a-c83c-488b-8c54-a59b62eba554_5267264c-fe2a-4728-8657-759504e26cc9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Reaction mass of 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide and 4-[[4-(aminocarbonyl)phenyl]azo]-3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide,61932-63-6,"Repeated oral toxicity  PR022 A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test was performed according to OECD TG 422. The test item was administered to Sprague Dawley rats (12/sex/dose) by gavage at dose levels of 0, 100, 300 and 1000 mg/kg/day for a total of 37 days (males) and through mating, gestation and delivery until day 4 of lactation (females). No toxic effects were observed in this study except increased liver weights in males and females of the highest dose group. As the effects on liver weight were minimal (less than 10% weight changes) and not accompanied by any histopathological or biochemical changes these effects were judged not to be adverse. The no-observed-adverse-effect level (NOAEL) for repeated dose toxicity was 1000 mg/kg under the conditions of this study. There were no effects on reproduction or development.   PR112 The toxicity of the test item when given by oral administration (gavage) to groups of 5 rats per sex per dose for 28 consecutive days at dosages of 0, 100, 300 or 1000 mg/kg bw/day, for 7 days/week have been investigated. No toxicologically significant changes were noted in any of the parameters investigated in this study (i.e. clinical appearance, functional observations, body weight, food consumption, clinical laboratory investigations, macroscopic examination, organ weights, and microscopic examination). Red staining of various body parts, red faeces and reddish contents of the gastro-intestinal tract noted among all groups treated with the test substance was considered to be related to staining properties of the test substance, and not to represent signs of systemic toxicity. No correlating histopathological abnormalities were noted. On the basis of these results, the high dose level of 1000 mg/kg/day was considered to be the No Observed Adverse Effect Level (NOAEL) for the test substance.   Repeated inhalation toxicity    PR112 The objective of the OECD TG 413 following study was to determine the toxic potential of the close analogue, Pigment Red 112, when administered for 6 hours/day, 5 days per week, for 13 consecutive weeks by flow-past nose-only inhalation route to Sprague Dawley rats. This study provides information on toxic effects, target organs, the possibility of cumulative effects, the reversibility of effects (after 90 and 180 days recovery period), and an estimate of the No Observed Adverse Effects Concentration (NOAEC). Based on the observed results, it is concluded that the No Observed Adverse Effect Concentration (NOAEC) of test item was found to be 30 mg/m³ (0,03 mg/L) after 90 days of exposure (highest concentration tested). The nominal dose of 0.03 mg/L (6 hrs/day, 5 days/week) corresponded to an actual exposure concentration in males and females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e72f2e3-791a-4152-b364-f7820c639889/documents/8f07e4c1-f641-4232-a7c4-4c8a44178226_61ac80f7-6986-4dd2-9ea0-cfef1a2db915.html,,,,,, Reaction mass of 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide and 4-[[4-(aminocarbonyl)phenyl]azo]-3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide,61932-63-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e72f2e3-791a-4152-b364-f7820c639889/documents/8f07e4c1-f641-4232-a7c4-4c8a44178226_61ac80f7-6986-4dd2-9ea0-cfef1a2db915.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Reaction mass of 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide and 4-[[4-(aminocarbonyl)phenyl]azo]-3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide,61932-63-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e72f2e3-791a-4152-b364-f7820c639889/documents/8f07e4c1-f641-4232-a7c4-4c8a44178226_61ac80f7-6986-4dd2-9ea0-cfef1a2db915.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,>= 30 mg/m3,,rat Reaction mass of 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide and 4-[[4-(aminocarbonyl)phenyl]azo]-3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide,61932-63-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e72f2e3-791a-4152-b364-f7820c639889/documents/8f07e4c1-f641-4232-a7c4-4c8a44178226_61ac80f7-6986-4dd2-9ea0-cfef1a2db915.html,Repeated dose toxicity – local effects,inhalation,NOAEC,>= 30 mg/m3,no adverse effect observed,rat Reaction mass of 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide and 4-[[4-(aminocarbonyl)phenyl]azo]-3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide,61932-63-6,"PR210 Female Wistar-rats were subjected to test acute oral toxicity. The test substance was administered by gavage at a dose of 15000 mg/kg bw (25 % suspension in sesame oil). No animal died during the 14 day observation period, resulting in a LD50 >15000 mg/kg bw. PR112 The Test item (<90% Pigment Red 112) did not cause any mortality or significant clinical signs or necropsy findings after single dermal application to male rats at 5000 mg/kg bw in a OECD guideline compliant study. The LD50 (male rat) was greater than 5000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e72f2e3-791a-4152-b364-f7820c639889/documents/4b51c70a-2efe-4ea9-a0e8-d39d567d6fb5_61ac80f7-6986-4dd2-9ea0-cfef1a2db915.html,,,,,, Reaction mass of 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide and 4-[[4-(aminocarbonyl)phenyl]azo]-3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide,61932-63-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e72f2e3-791a-4152-b364-f7820c639889/documents/4b51c70a-2efe-4ea9-a0e8-d39d567d6fb5_61ac80f7-6986-4dd2-9ea0-cfef1a2db915.html,,oral,LD50,"> 15,000 mg/kg bw",no adverse effect observed, Reaction mass of 4-[[4-(aminocarbonyl)phenyl]azo]-N-(2-ethoxyphenyl)-3-hydroxynaphthalene-2-carboxamide and 4-[[4-(aminocarbonyl)phenyl]azo]-3-hydroxy-N-(2-methoxyphenyl)naphthalene-2-carboxamide,61932-63-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e72f2e3-791a-4152-b364-f7820c639889/documents/4b51c70a-2efe-4ea9-a0e8-d39d567d6fb5_61ac80f7-6986-4dd2-9ea0-cfef1a2db915.html,,dermal,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Reaction mass of 6-O-alfa-D-glucopyranosyl-D-fructofuranose and 1-O-alfa-D-glucopyranosyl-D-fructofuranoseand D-fructofuranose,1236007-63-8,A 13-week (90-day) oral toxicity study was conducted in rats under GLP conditions. No effects were observed in any animal in any dose. Isomaltulose greens is not toxic to rats at doses up to and including 10% in the diet. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63473609-e9f2-48c5-8870-f0d37a4238d3/documents/IUC5-ad38d099-8733-4bb5-aeb7-eedf568ec088_c19c2307-e503-4cff-a893-f22e36a71277.html,,,,,, Reaction mass of 6-O-alfa-D-glucopyranosyl-D-fructofuranose and 1-O-alfa-D-glucopyranosyl-D-fructofuranoseand D-fructofuranose,1236007-63-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/63473609-e9f2-48c5-8870-f0d37a4238d3/documents/IUC5-ad38d099-8733-4bb5-aeb7-eedf568ec088_c19c2307-e503-4cff-a893-f22e36a71277.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"7,000 mg/kg bw/day",,rat Reaction mass of 6-O-alfa-D-glucopyranosyl-D-fructofuranose and 1-O-alfa-D-glucopyranosyl-D-fructofuranoseand D-fructofuranose,1236007-63-8,"Acute toxicity data are available from longer-term repeated dose studies conducted on both isomaltulose greens and isomaltulose. In both studies doses higher than the standard acute toxicity limit dose were given orally by gavage daily for 26 weeks. No acute toxicity signs were observed in either study, demonstrating that isomaltulose greens are not acute toxic. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63473609-e9f2-48c5-8870-f0d37a4238d3/documents/IUC5-f03e26d6-3371-4e07-8cc4-70cf26627f5c_c19c2307-e503-4cff-a893-f22e36a71277.html,,,,,, Reaction mass of 6-O-alfa-D-glucopyranosyl-D-fructofuranose and 1-O-alfa-D-glucopyranosyl-D-fructofuranoseand D-fructofuranose,1236007-63-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63473609-e9f2-48c5-8870-f0d37a4238d3/documents/IUC5-f03e26d6-3371-4e07-8cc4-70cf26627f5c_c19c2307-e503-4cff-a893-f22e36a71277.html,,oral,LD50,"4,500 mg/kg bw",, "Reaction mass of 7-azatridecane-1,13-diamine and hexamethylenediamine",68815-47-4,In a subchronic toxicity study the submission susbtance was administered orally to rats. The NOAEL of this study is 20 mg/kg bw/day as respiratory rales were seen in male and female rats when higher doses were tested. In another subchronic toxicity study rats were exposed to an aerosol containing the submission substance. Based on the lesions seen in the respiratory tract throughout all exposure concentrations the LOAEC of this study is 15.8 mg per cubic metre air. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ef6693e-fc24-42ef-926f-47c876a2016c/documents/IUC5-8600a4e9-b50d-48d6-a29f-c08ed40f739b_e3cb519b-a46e-46bd-9baf-c050577ea85e.html,,,,,, "Reaction mass of 7-azatridecane-1,13-diamine and hexamethylenediamine",68815-47-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5ef6693e-fc24-42ef-926f-47c876a2016c/documents/IUC5-8600a4e9-b50d-48d6-a29f-c08ed40f739b_e3cb519b-a46e-46bd-9baf-c050577ea85e.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15.8 mg/m3,adverse effect observed,rat "Reaction mass of 7-azatridecane-1,13-diamine and hexamethylenediamine",68815-47-4,Testing for acute oral toxicity in rats revealed a reliable LD50 to be 562 mg/kg bw. Testing for acute dermal toxicity a median lethal dose of 1500 mg/kg bw in rats was found. No mortality was observed when rats were exposed for 8 hours to saturated vapour of the submission substance (i.e. nominal concentration 3.1 mg/l). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ef6693e-fc24-42ef-926f-47c876a2016c/documents/IUC5-4a9e67b5-e63a-40b3-8bfa-360338654193_e3cb519b-a46e-46bd-9baf-c050577ea85e.html,,,,,, "Reaction mass of 7-azatridecane-1,13-diamine and hexamethylenediamine",68815-47-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ef6693e-fc24-42ef-926f-47c876a2016c/documents/IUC5-4a9e67b5-e63a-40b3-8bfa-360338654193_e3cb519b-a46e-46bd-9baf-c050577ea85e.html,,oral,LD50,562 mg/kg bw,adverse effect observed, "Reaction mass of 7-azatridecane-1,13-diamine and hexamethylenediamine",68815-47-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ef6693e-fc24-42ef-926f-47c876a2016c/documents/IUC5-4a9e67b5-e63a-40b3-8bfa-360338654193_e3cb519b-a46e-46bd-9baf-c050577ea85e.html,,dermal,LD50,"1,500 mg/kg bw",adverse effect observed, "Reaction mass of 7-azatridecane-1,13-diamine and hexamethylenediamine",68815-47-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5ef6693e-fc24-42ef-926f-47c876a2016c/documents/IUC5-4a9e67b5-e63a-40b3-8bfa-360338654193_e3cb519b-a46e-46bd-9baf-c050577ea85e.html,,inhalation,discriminating conc.,"3,100 mg/m3",no adverse effect observed, "Reaction mass of Bis(1,2,2,6,6-pentamethyl-4-piperidyl) sebacate and Methyl 1,2,2,6,6-pentamethyl-4-piperidyl sebacate",1065336-91-5," In all repeated dose oral toxicity studies with the source and target chemical in rats and dogs, administration of test material was associated with decreased body weight gain. In a 28-Day oral toxicity study with the target chemical in rats, a NOAEL was established at 300 mg/kg/day. In an OECD 422 study with the target chemical, the NOAEL was 5000 ppm (corresponding to an actual test article intake of 469 and 804 mg/kg/day for males and females, respectively, based on reduced body weights at 15000 ppm). In a parallel performed OECD 422 with the source chemical, additional histological changes in the heart in males were reported, which were, however, not confirmed in a follow-up OECD 443 study with 10 week premating treatment with the source chemical. In this OECD 443, effects on body weights were also reported with a NOAEL of 36 mg/kg body weight. The 90-day NOEL for oral toxicity (gavage) forthe source substance in rats was < 29 mg/kg bw based on reduced body weight gain in females. However, since the studd also reported inflammation in all dose groups, the reliability of this study may have been compromised, as confirmed by ECHA in their final decision (Decision number: CCH-D-2114384240 -56 -01/F). Finally, the 90-day NOAEL for oral toxicity (feed) of the source substance in dogs was 2600 ppm (69-78 mg/kg bw) based on decreased body weight and liver hypertrophy. The most reliable systemic NOAEL was is consiered the NOAEL of 36 mg/kg body weight derived in the OECD 443 study (see chapter 7.8.1). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/23a52458-574e-4133-a3a3-b8bdcd0dd4dd/documents/31576bec-a7fe-4d4b-9b7a-fa1f739ce6d1_c78e7f0c-74d7-48f0-8355-7c6e76521c7e.html,,,,,, "Reaction mass of Bis(1,2,2,6,6-pentamethyl-4-piperidyl) sebacate and Methyl 1,2,2,6,6-pentamethyl-4-piperidyl sebacate",1065336-91-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/23a52458-574e-4133-a3a3-b8bdcd0dd4dd/documents/31576bec-a7fe-4d4b-9b7a-fa1f739ce6d1_c78e7f0c-74d7-48f0-8355-7c6e76521c7e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,36 mg/kg bw/day,,rat "Reaction mass of Bis(1,2,2,6,6-pentamethyl-4-piperidyl) sebacate and Methyl 1,2,2,6,6-pentamethyl-4-piperidyl sebacate",1065336-91-5," The test article is of low toxicity after single ingestion and virtually non toxic after single skin contact. Oral: LD50 = 3230 mg/kg bw Dermal: LD50 = >3000 mg/kg bw (no study available, assessment based on data from a structurally related compound) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23a52458-574e-4133-a3a3-b8bdcd0dd4dd/documents/95bb5c1d-afaa-4988-937e-bd1858d5faa3_c78e7f0c-74d7-48f0-8355-7c6e76521c7e.html,,,,,, "Reaction mass of Bis(1,2,2,6,6-pentamethyl-4-piperidyl) sebacate and Methyl 1,2,2,6,6-pentamethyl-4-piperidyl sebacate",1065336-91-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23a52458-574e-4133-a3a3-b8bdcd0dd4dd/documents/95bb5c1d-afaa-4988-937e-bd1858d5faa3_c78e7f0c-74d7-48f0-8355-7c6e76521c7e.html,,oral,LD50,"3,230 mg/kg bw",adverse effect observed, "Reaction mass of Bis(1,2,2,6,6-pentamethyl-4-piperidyl) sebacate and Methyl 1,2,2,6,6-pentamethyl-4-piperidyl sebacate",1065336-91-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23a52458-574e-4133-a3a3-b8bdcd0dd4dd/documents/95bb5c1d-afaa-4988-937e-bd1858d5faa3_c78e7f0c-74d7-48f0-8355-7c6e76521c7e.html,,dermal,LD50,"3,170 mg/kg bw",no adverse effect observed, "1,4-Benzenedicarboxylic acid, mixed Bu and 2-ethylhexyl diesters",1571954-81-8," It is concluded that oral administration of GL500 to Han Wistar rats for 13 weeks at doses up to 1000 mg/kg/day did not cause any toxicologically significant response to treatment.  There was an adaptive response in the liver at 1000 mg/kg/day that resulted in a secondary, rodent-specific stimulation of the thyroid gland.  The thyroid gland findings were also present at 300mg/kg/day.  Since none of the findings in this study was considered adverse, the no-observed-adverse-effect level (NOAEL) in this study was considered to be 1000mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6eef297f-3496-4f1e-ba60-0b813bc02be2/documents/5b4ff625-1d09-47d0-b123-bfbe11dfa45f_10b486b0-5d44-4ea8-9b35-4e977a357ff3.html,,,,,, "1,4-Benzenedicarboxylic acid, mixed Bu and 2-ethylhexyl diesters",1571954-81-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6eef297f-3496-4f1e-ba60-0b813bc02be2/documents/5b4ff625-1d09-47d0-b123-bfbe11dfa45f_10b486b0-5d44-4ea8-9b35-4e977a357ff3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,4-Benzenedicarboxylic acid, mixed Bu and 2-ethylhexyl diesters",1571954-81-8," The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000mg/kg body weight (CLP-Unclassified). The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight. The test item does not meet the criteria for classification according to Regulation (EC) No. 1272/2008, relating to the Classification, Labelling and Packaging of Substances and Mixtures. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6eef297f-3496-4f1e-ba60-0b813bc02be2/documents/4bdafa3f-060f-4dc3-868a-9f86ff4cad92_10b486b0-5d44-4ea8-9b35-4e977a357ff3.html,,,,,, "1,4-Benzenedicarboxylic acid, mixed Bu and 2-ethylhexyl diesters",1571954-81-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6eef297f-3496-4f1e-ba60-0b813bc02be2/documents/4bdafa3f-060f-4dc3-868a-9f86ff4cad92_10b486b0-5d44-4ea8-9b35-4e977a357ff3.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "1,4-Benzenedicarboxylic acid, mixed Bu and 2-ethylhexyl diesters",1571954-81-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6eef297f-3496-4f1e-ba60-0b813bc02be2/documents/4bdafa3f-060f-4dc3-868a-9f86ff4cad92_10b486b0-5d44-4ea8-9b35-4e977a357ff3.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, reaction mass of cis 4-(3-methylbutyl)cyclohexanol and trans 4-(3-methylbutyl)cyclohexanol,830322-14-0,"LD50 (rat), oral:   > 2000 mg/kg b.w.   (OECD 423 / EC B.1, GLP); limit test ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/28bc6205-ae95-4817-be7e-eaea064c44b3/documents/IUC5-71d28b62-d069-4572-9fb2-11093b352361_21de05dc-2b06-4518-99cf-c24a94967cae.html,,,,,, "phosphourous acid, mixed 4-isononylphenyl and lauryl and tridecyl triesters",213077-23-7, Acute oral toxicity in rats (comparable to OECD 401) Acute dermal toxicity in rats (OECD 402) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a106189-81e2-4841-b03f-993b75b4fdb9/documents/02b09508-849b-4fdd-ae4e-cabb36cb1e2b_9c18deed-325f-49fe-88e9-9257c2bc5946.html,,,,,, "phosphourous acid, mixed 4-isononylphenyl and lauryl and tridecyl triesters",213077-23-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a106189-81e2-4841-b03f-993b75b4fdb9/documents/02b09508-849b-4fdd-ae4e-cabb36cb1e2b_9c18deed-325f-49fe-88e9-9257c2bc5946.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "phosphourous acid, mixed 4-isononylphenyl and lauryl and tridecyl triesters",213077-23-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a106189-81e2-4841-b03f-993b75b4fdb9/documents/02b09508-849b-4fdd-ae4e-cabb36cb1e2b_9c18deed-325f-49fe-88e9-9257c2bc5946.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, reaction mass of diethyl (E)-2-methylbut-2-enedioate and diethyl (Z)-2-methylbut-2-enedioate,73326-59-7, Acute toxicity: oral The LD50 value of the test item was determined to be higher than 2000 mg/kg bw after single oral administration in female rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c334d30f-c153-426c-af09-df58138ed68d/documents/91e844da-9815-40dd-bc66-18644f7e76d6_b1b13004-ad82-48b7-8e1f-998284b9f90d.html,,,,,, reaction mass of diethyl (E)-2-methylbut-2-enedioate and diethyl (Z)-2-methylbut-2-enedioate,73326-59-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c334d30f-c153-426c-af09-df58138ed68d/documents/91e844da-9815-40dd-bc66-18644f7e76d6_b1b13004-ad82-48b7-8e1f-998284b9f90d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Reaction mass of ethyl (2S,3S)-3,4-dibromo-2-methylbutanoate and ethyl (2R,3R)-3,4-dibromo-2-methylbutanoate and ethyl (2S,3R)-3,4-dibromo-2-methylbutanoate and ethyl (2R,3S)-3,4-dibromo-2-methylbutanoate",1160806-44-9,No data is available. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f19b0745-e70a-4bcc-a2a9-cda79adec470/documents/IUC5-924755a4-f910-41e8-bf98-ab546435508d_266db2fb-7a4d-490b-8833-1cae89643545.html,,,,,, "Reaction mass of ethyl (2S,3S)-3,4-dibromo-2-methylbutanoate and ethyl (2R,3R)-3,4-dibromo-2-methylbutanoate and ethyl (2S,3R)-3,4-dibromo-2-methylbutanoate and ethyl (2R,3S)-3,4-dibromo-2-methylbutanoate",1160806-44-9,"ORAL LD50 (rat) > 2000 mg/kg bw (acute toxic class method; OECD TG 423) (BASF SE, 2009). Classification: not classified (EU); Cat. 5 (OECD GHS). No labeling required. DERMAL and INHALATION No data is available / required. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f19b0745-e70a-4bcc-a2a9-cda79adec470/documents/IUC5-7a204d16-28c0-4a65-8fdd-98c859748064_266db2fb-7a4d-490b-8833-1cae89643545.html,,,,,, "Reaction mass of hexasodium 2-[{8-amino-7-[(5-{[4-chloro-6-(4-{[2-(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5-triazin-2-yl]amino}-2-sulfonatophenyl)diazenyl]-1-yhdroxy-3,6-disulfonato-2-naphthyl}diazenyl]naphthalene-1,5-disulfonate and pentasodiu2-[(8-amino-7-{[5-({4-chloro-6-[4-(vinylsulfonyl)anilino]-1,3,5-triazin-2-yl}amino) -2-sulfonatophenyl]diazenyl}-1-hydroxy-3,6-disulfonato-2-naphthyl)diazenyl]naphthalene-1,5-disulfonate",80315-17-9," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats and mice for the test chemical. The LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/041af1ea-9668-4834-9abd-12e12b7d38c3/documents/354a669c-eb6c-443e-9b8e-bb19320632bf_9548de49-92c8-4cd0-985e-b96e4dfbb8c1.html,,,,,, "Reaction mass of hexasodium 2-[{8-amino-7-[(5-{[4-chloro-6-(4-{[2-(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5-triazin-2-yl]amino}-2-sulfonatophenyl)diazenyl]-1-yhdroxy-3,6-disulfonato-2-naphthyl}diazenyl]naphthalene-1,5-disulfonate and pentasodiu2-[(8-amino-7-{[5-({4-chloro-6-[4-(vinylsulfonyl)anilino]-1,3,5-triazin-2-yl}amino) -2-sulfonatophenyl]diazenyl}-1-hydroxy-3,6-disulfonato-2-naphthyl)diazenyl]naphthalene-1,5-disulfonate",80315-17-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/041af1ea-9668-4834-9abd-12e12b7d38c3/documents/354a669c-eb6c-443e-9b8e-bb19320632bf_9548de49-92c8-4cd0-985e-b96e4dfbb8c1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction mass of hexasodium 2-[{8-amino-7-[(5-{[4-chloro-6-(4-{[2-(sulfonatooxy)ethyl]sulfonyl}anilino)-1,3,5-triazin-2-yl]amino}-2-sulfonatophenyl)diazenyl]-1-yhdroxy-3,6-disulfonato-2-naphthyl}diazenyl]naphthalene-1,5-disulfonate and pentasodiu2-[(8-amino-7-{[5-({4-chloro-6-[4-(vinylsulfonyl)anilino]-1,3,5-triazin-2-yl}amino) -2-sulfonatophenyl]diazenyl}-1-hydroxy-3,6-disulfonato-2-naphthyl)diazenyl]naphthalene-1,5-disulfonate",80315-17-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/041af1ea-9668-4834-9abd-12e12b7d38c3/documents/354a669c-eb6c-443e-9b8e-bb19320632bf_9548de49-92c8-4cd0-985e-b96e4dfbb8c1.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "reaction mass of isomers of: C7-9-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate",125643-61-0," As evident from all available repeated dose toxicity studies, the analogous substances possess very low toxicity potential by prolonged exposures both by oral and dermal routes of exposure. They did not induce mortality and no toxicologically significant clinical observations were detected in treated animals. Behavioural and functional performance parameters and sensory reactivity were generally without changes except some incidental transient findings. In the sub-chronic studies, animals showed statistically significant reduced body weight, while in sub-acute studies bodyweight development was not meaningful changed. Haematological and blood chemical parameters were slightly altered, probably as consequence of the adaptive change in liver function and had minimal physiological effect on the overall health of the animals. At necropsy, no toxicologically significant macroscopic abnormalities were detected. Significantly increased liver weight and centrilobular hepatocyte enlargement are common observations, which are often observed in rodents following the administration of xenobiotics and are usually the result of detoxification mechanism. The histopathological changes observed in liver and in other organs collectively represent adaptive response and considered non-adverse effects of treatment. The NOAEL established was the highest dose level tested in four repeated dose toxicity studies. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e4940b7-bd2b-47c6-8db7-1aaf080e3d81/documents/6177b80a-4e8c-443d-ab3c-473f55c900de_93a545d6-51ac-4934-9a6a-8af9c0e92e90.html,,,,,, "reaction mass of isomers of: C7-9-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate",125643-61-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e4940b7-bd2b-47c6-8db7-1aaf080e3d81/documents/6177b80a-4e8c-443d-ab3c-473f55c900de_93a545d6-51ac-4934-9a6a-8af9c0e92e90.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rat "reaction mass of isomers of: C7-9-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate",125643-61-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e4940b7-bd2b-47c6-8db7-1aaf080e3d81/documents/6177b80a-4e8c-443d-ab3c-473f55c900de_93a545d6-51ac-4934-9a6a-8af9c0e92e90.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,186 mg/kg bw/day,,rat "reaction mass of isomers of: C7-9-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate",125643-61-0,"LD50 of 2000 mg/kg/bw was established in the available studies for the related substances of C7-C9-alkyl 3-(3,5-di-tert-butyl-4 hydroxyphenyl)propionate, indicating low acute toxicity potential by both oral and dermal routes of exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e4940b7-bd2b-47c6-8db7-1aaf080e3d81/documents/975f558d-98e7-48a5-9d12-f6645883c900_93a545d6-51ac-4934-9a6a-8af9c0e92e90.html,,,,,, "reaction mass of isomers of: C7-9-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate",125643-61-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e4940b7-bd2b-47c6-8db7-1aaf080e3d81/documents/975f558d-98e7-48a5-9d12-f6645883c900_93a545d6-51ac-4934-9a6a-8af9c0e92e90.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "reaction mass of isomers of: C7-9-alkyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate",125643-61-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e4940b7-bd2b-47c6-8db7-1aaf080e3d81/documents/975f558d-98e7-48a5-9d12-f6645883c900_93a545d6-51ac-4934-9a6a-8af9c0e92e90.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Reaction mass of methyl 2-({(E)-[4-(4-hydroxy-4-methylpentyl)cyclohex-3-en-1-ylidene]methyl}amino)benzoate and methyl 2-({(E)-[3-(4-hydroxy-4-methylpentyl)cyclohex-3-en-1-ylidene]methyl}amino)benzoate and methyl 2-({(Z)-[4-(4-hydroxy-4-methylpentyl)cyclohex-3-en-1-ylidene]methyl}amino)benzoate and methyl 2-({(Z)-[3-(4-hydroxy-4-methylpentyl)cyclohex-3-en-1-ylidene]methyl}amino)benzoate,2059116-34-4,Acute oral toxicity: OECD TG 420: LD50 > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bec828a-b2cc-49a8-83c0-f149b4a0545e/documents/3e98ac61-caf8-44fb-9b65-695be2d9561d_0fab0b93-798e-4f77-a228-63f7cf9c0cfa.html,,,,,, Reaction mass of methyl 2-({(E)-[4-(4-hydroxy-4-methylpentyl)cyclohex-3-en-1-ylidene]methyl}amino)benzoate and methyl 2-({(E)-[3-(4-hydroxy-4-methylpentyl)cyclohex-3-en-1-ylidene]methyl}amino)benzoate and methyl 2-({(Z)-[4-(4-hydroxy-4-methylpentyl)cyclohex-3-en-1-ylidene]methyl}amino)benzoate and methyl 2-({(Z)-[3-(4-hydroxy-4-methylpentyl)cyclohex-3-en-1-ylidene]methyl}amino)benzoate,2059116-34-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3bec828a-b2cc-49a8-83c0-f149b4a0545e/documents/3e98ac61-caf8-44fb-9b65-695be2d9561d_0fab0b93-798e-4f77-a228-63f7cf9c0cfa.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tris[4-(diethylamino)phenyl]methylium acetate,63157-72-2,"The oral administration of ethylviolet acetate by gavage over a period of 4 weeks revealed severe signs of toxicity in male and female Wistar rats at dose levels of 100 and 60 mg/kg bw/day as well as 30 and 20 mg/kg bw/day. Therefore, under the conditions of the present study, the NOAEL was 10 mg/kg bw/day for male and female Wistar rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f29a69f0-bd3e-48ed-ab62-311d75c3deda/documents/IUC5-135e9442-2ffe-433d-9367-846c4542b8f7_3bf840a0-7021-4c6e-b7ff-e1dc567bf4ca.html,,,,,, Tris[4-(diethylamino)phenyl]methylium acetate,63157-72-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f29a69f0-bd3e-48ed-ab62-311d75c3deda/documents/IUC5-135e9442-2ffe-433d-9367-846c4542b8f7_3bf840a0-7021-4c6e-b7ff-e1dc567bf4ca.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Tris[4-(diethylamino)phenyl]methylium acetate,63157-72-2,LD50 rat (oral): ca. 234 mg/kg bwLC50 rat (by inhalation; inhalation hazard test): > 4.32 mg/l air ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f29a69f0-bd3e-48ed-ab62-311d75c3deda/documents/IUC5-10c48adc-3557-458d-9c69-6cf5bc15193b_3bf840a0-7021-4c6e-b7ff-e1dc567bf4ca.html,,,,,, Tris[4-(diethylamino)phenyl]methylium acetate,63157-72-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f29a69f0-bd3e-48ed-ab62-311d75c3deda/documents/IUC5-10c48adc-3557-458d-9c69-6cf5bc15193b_3bf840a0-7021-4c6e-b7ff-e1dc567bf4ca.html,,oral,LD50,234 mg/kg bw,adverse effect observed, "Reaction mass of N1-benzylpropane-1,2-diamine and N2-benzylpropane-1,2-diamine",1802727-84-9, For the acute oral toxicity study with the test item in rats the determined LD50 is between 300 and 2000 mg/kg bw. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5a70d0e-4db9-4063-a2ad-6b0e553c4ab4/documents/a99c147a-e7c0-4ca7-95dc-33a9a469dec2_4ead4520-5faa-4760-9ec7-1ab9ba68eae2.html,,,,,, "Reaction mass of Pentaerythritol bis (2-ethylhexanoate) bis (3,5,5-trimethylhexanoate) and Pentaerythritol tris (2-ethylhexanoate) 3,5,5-trimethylhexanoate and Pentaerythritol 2-ethylhexanoate tris (3,5,5-trimethylhexanoate) and Pentaeryhthritol tetrakis(2-ethylhexanoate) and Pentaerythritol tetrakis (3,5,5-trimethylhexanoate)",153965-54-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Two studies were used that were found to be reliable under previous evaluation scheme. The potential adversity and the relevance of the results were re-evaluated in light of the screening study for reproduction and developmental toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea6ccec3-5227-47ec-9c45-a854ec56e99f/documents/57984d89-a713-44ba-9e8d-823c171c1110_52432951-4da6-4ebd-9e78-65c07fef8da7.html,,,,,, "Reaction mass of Pentaerythritol bis (2-ethylhexanoate) bis (3,5,5-trimethylhexanoate) and Pentaerythritol tris (2-ethylhexanoate) 3,5,5-trimethylhexanoate and Pentaerythritol 2-ethylhexanoate tris (3,5,5-trimethylhexanoate) and Pentaeryhthritol tetrakis(2-ethylhexanoate) and Pentaerythritol tetrakis (3,5,5-trimethylhexanoate)",153965-54-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea6ccec3-5227-47ec-9c45-a854ec56e99f/documents/57984d89-a713-44ba-9e8d-823c171c1110_52432951-4da6-4ebd-9e78-65c07fef8da7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Reaction mass of Pentaerythritol bis (2-ethylhexanoate) bis (3,5,5-trimethylhexanoate) and Pentaerythritol tris (2-ethylhexanoate) 3,5,5-trimethylhexanoate and Pentaerythritol 2-ethylhexanoate tris (3,5,5-trimethylhexanoate) and Pentaeryhthritol tetrakis(2-ethylhexanoate) and Pentaerythritol tetrakis (3,5,5-trimethylhexanoate)",153965-54-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study has klimisch code 1. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study has klimisch code 1. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea6ccec3-5227-47ec-9c45-a854ec56e99f/documents/d598a173-7603-49aa-81ee-1992ea9783cc_52432951-4da6-4ebd-9e78-65c07fef8da7.html,,,,,, "Reaction mass of Pentaerythritol bis (2-ethylhexanoate) bis (3,5,5-trimethylhexanoate) and Pentaerythritol tris (2-ethylhexanoate) 3,5,5-trimethylhexanoate and Pentaerythritol 2-ethylhexanoate tris (3,5,5-trimethylhexanoate) and Pentaeryhthritol tetrakis(2-ethylhexanoate) and Pentaerythritol tetrakis (3,5,5-trimethylhexanoate)",153965-54-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea6ccec3-5227-47ec-9c45-a854ec56e99f/documents/d598a173-7603-49aa-81ee-1992ea9783cc_52432951-4da6-4ebd-9e78-65c07fef8da7.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction mass of Pentaerythritol bis (2-ethylhexanoate) bis (3,5,5-trimethylhexanoate) and Pentaerythritol tris (2-ethylhexanoate) 3,5,5-trimethylhexanoate and Pentaerythritol 2-ethylhexanoate tris (3,5,5-trimethylhexanoate) and Pentaeryhthritol tetrakis(2-ethylhexanoate) and Pentaerythritol tetrakis (3,5,5-trimethylhexanoate)",153965-54-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea6ccec3-5227-47ec-9c45-a854ec56e99f/documents/d598a173-7603-49aa-81ee-1992ea9783cc_52432951-4da6-4ebd-9e78-65c07fef8da7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium prop-2-enesulphonate,2495-39-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83c289ff-fb62-411e-b9c1-72e95469d120/documents/IUC5-8ceaeef9-a82a-47a6-8636-ccc4ddb4a1cd_33a2c002-bcd0-43fa-95d0-83943145180e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Sodium prop-2-enesulphonate,2495-39-8,"oralrat: LD50 >2000 mg/kg bw (comparable to OECD 401; BASF AG 1975)dermalrat: LD50 >2000 mg/kg bw; Signs of toxicity were not noted (GLP, OECD 402; BASF SE 2010)inhalationrat: IHT, 8h: 0/12 animals died after exposure to a saturated atmosphere; signs of systemic toxicity were not noted (comparable to OECD 403; BASF AG 1975) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83c289ff-fb62-411e-b9c1-72e95469d120/documents/IUC5-1534f026-33a9-4249-b5bd-fb5ba40ad522_33a2c002-bcd0-43fa-95d0-83943145180e.html,,,,,, "reaction mass of: pentasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}naphthalene-2,7-disulfonate,tetrasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate,tetrasodium 4-amino-5-hydroxy-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-3-[(E)-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonatetrisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate,trisodium 4-amino-5-hydroxy-3-[(2-hydroxyethylsulfonyl)-phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate,trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[(E)-2-sulfonato-4-(2-hydroxyethylsulfonyl)phenylazo]naphthalene-2,7-disulfonate",371921-40-3,LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73dec6fc-bd39-4d59-a91c-f5ccf28367ec/documents/0e989fd9-85e9-40b9-b6a8-8c98ffc7aaa2_6bc71f41-dddb-419d-b186-b420279dfaea.html,,,,,, "reaction mass of: pentasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}naphthalene-2,7-disulfonate,tetrasodium 4-amino-5-hydroxy-3-{(E)-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate,tetrasodium 4-amino-5-hydroxy-6-{(E)-2-sulfonato-4-[2-(sulfonatooxy)ethylsulfonyl]phenylazo}-3-[(E)-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonatetrisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate,trisodium 4-amino-5-hydroxy-3-[(2-hydroxyethylsulfonyl)-phenylazo]-6-[(E)-2-sulfonato-4-(vinylsulfonyl)phenylazo]naphthalene-2,7-disulfonate,trisodium 4-amino-5-hydroxy-3-[(E)-4-(vinylsulfonyl)phenylazo]-6-[(E)-2-sulfonato-4-(2-hydroxyethylsulfonyl)phenylazo]naphthalene-2,7-disulfonate",371921-40-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73dec6fc-bd39-4d59-a91c-f5ccf28367ec/documents/0e989fd9-85e9-40b9-b6a8-8c98ffc7aaa2_6bc71f41-dddb-419d-b186-b420279dfaea.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Reaction mass of: Pentasodium bis(6-anilino-3,5'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato)cobaltate(III)",508202-43-5," NOAEL (oral, 28 d) = 200 mg/kg/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73e914f5-fbe7-4a34-bb8f-e42334c98d5c/documents/7b9f4057-731f-4bc2-8bb9-6f8678b58c39_53e39190-c945-40b5-9a50-d2cc826c6237.html,,,,,, "Reaction mass of: Pentasodium bis(6-anilino-3,5'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato)cobaltate(III)",508202-43-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73e914f5-fbe7-4a34-bb8f-e42334c98d5c/documents/7b9f4057-731f-4bc2-8bb9-6f8678b58c39_53e39190-c945-40b5-9a50-d2cc826c6237.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Reaction mass of: Pentasodium bis(6-anilino-3,5'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato)cobaltate(III)",508202-43-5," LD50 (rat, oral) > 2000 mg/kg bw LD50 (rat, dermal) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73e914f5-fbe7-4a34-bb8f-e42334c98d5c/documents/8ef77186-e317-4e53-8183-c475e92c989c_53e39190-c945-40b5-9a50-d2cc826c6237.html,,,,,, "Reaction mass of: Pentasodium bis(6-anilino-3,5'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato)cobaltate(III)",508202-43-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73e914f5-fbe7-4a34-bb8f-e42334c98d5c/documents/8ef77186-e317-4e53-8183-c475e92c989c_53e39190-c945-40b5-9a50-d2cc826c6237.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction mass of: Pentasodium bis(6-anilino-3,5'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato)cobaltate(III)",508202-43-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73e914f5-fbe7-4a34-bb8f-e42334c98d5c/documents/8ef77186-e317-4e53-8183-c475e92c989c_53e39190-c945-40b5-9a50-d2cc826c6237.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs.",68071-40-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): One acute oral toxicity study available performed in accordance to OECD and GLP criteria with reliability score of 1. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1754859-68eb-4291-90bb-5e3ccc93072d/documents/8ae8e22d-3546-4b1a-b153-cc2e492dba40_45fcb8c3-085d-4978-b63e-bdcd572e625a.html,,,,,, "Reaction product of 2-Propenoic acid and Oxirane, mono[(C12-16-alkyloxy)methyl] derivs.",68071-40-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1754859-68eb-4291-90bb-5e3ccc93072d/documents/8ae8e22d-3546-4b1a-b153-cc2e492dba40_45fcb8c3-085d-4978-b63e-bdcd572e625a.html,,oral,,"5,000 mg/kg bw",no adverse effect observed, "Reaction product of 3,5,5-trimethyl-hexanoic acid and 2-methylpropanoic acid and pentaerythritol",1262967-45-2, NOAEL (systemic toxicity) =  100 mg/kg/day); OECD 408; Cooper S. (2012) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a16ce5a-1c3a-430f-9305-29c5edd70091/documents/c5e89c48-fd16-41b6-95da-b16af2ab431c_6ad44361-d967-4b4a-a17c-056c57e6401a.html,,,,,, "Reaction product of 3,5,5-trimethyl-hexanoic acid and 2-methylpropanoic acid and pentaerythritol",1262967-45-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a16ce5a-1c3a-430f-9305-29c5edd70091/documents/c5e89c48-fd16-41b6-95da-b16af2ab431c_6ad44361-d967-4b4a-a17c-056c57e6401a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Reaction product of 3,5,5-trimethyl-hexanoic acid and 2-methylpropanoic acid and pentaerythritol",1262967-45-2," Acute oral LD50: >2000 mg/kg bw; OECD 423; Bull, A. (2012) Acute dermal LD50: >2000 mg/kg bw; OECD 402; Bull, A. (2012) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a16ce5a-1c3a-430f-9305-29c5edd70091/documents/047378c1-44ae-4d45-b79b-5e52e0b2f7ff_6ad44361-d967-4b4a-a17c-056c57e6401a.html,,,,,, "Reaction product of 3,5-Di-tert-butylsalicylic acid and Zirconium oxychloride, Dehydrated, Basic ZR : dtbs = 1.0 : 1.0 TO 1.0 : 1.5",226996-19-6, Oral: 15 mg/kg bw/d is the no-observed-adverse-effect-level (NOAEL) and the no-observed-effect-level (NOEL) for male and female rats. Inhalative: Test not done as test substance was not classified in acute test. Dermal: Test not done as test substance was not classified in acute test. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4db272cc-7023-4b9c-8e77-d1fdcd520f17/documents/c7eef103-9fa3-48b7-8824-9730748ff3e4_6bf735c9-4b39-4596-a9f2-53b74eed0234.html,,,,,, "Reaction product of 3,5-Di-tert-butylsalicylic acid and Zirconium oxychloride, Dehydrated, Basic ZR : dtbs = 1.0 : 1.0 TO 1.0 : 1.5",226996-19-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4db272cc-7023-4b9c-8e77-d1fdcd520f17/documents/c7eef103-9fa3-48b7-8824-9730748ff3e4_6bf735c9-4b39-4596-a9f2-53b74eed0234.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat Reaction product of 4-aminophenol with 2-ethyl-6-methylbenzenamine and sodium polysulfide,1040873-93-5," The test item did not cause adverse effects in male or female Hsd.Han:Wistar rats during the course of a consecutive 14 days oral administration at 0, 100, 300 or 1000 mg dye/kg bw/day (corresponding to 0, 115, 345 and 1150 mg test item/kg bw/d). A NOAEL of 1000 mg/kg bw/day was determined. In a study according OECD TG 422 rats were administered at 100, 300 or 1000 mg dye/kg bw/day (corresponding to 115, 345 and 1150 mg test item/kg bw/d) by oral gavage and neither signs of systemic toxicity nor adversely influence on the reproductive performance (gonad function, mating behavior, conception, parturition) in parental male and female Han:WIST rats were detected. The NOAEL of 1000 mg/kg bw/d war derived. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1d018af3-7d7a-4daf-a342-ce58aebd7804/documents/69241c42-12f5-4a00-be41-2871778838d0_62b7036d-76ad-4017-b5d7-17a259cf1823.html,,,,,, Reaction product of 4-aminophenol with 2-ethyl-6-methylbenzenamine and sodium polysulfide,1040873-93-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1d018af3-7d7a-4daf-a342-ce58aebd7804/documents/69241c42-12f5-4a00-be41-2871778838d0_62b7036d-76ad-4017-b5d7-17a259cf1823.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Reaction product of 4-aminophenol with 2-ethyl-6-methylbenzenamine and sodium polysulfide,1040873-93-5, In an acute oral toxicity study in rats the acute oral LD50 was determined to be > 2000 mg dye/kg bw (corresponding to > 2300 mg product/kg bw). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d018af3-7d7a-4daf-a342-ce58aebd7804/documents/d8666264-4700-41d0-8469-ba3156086ad7_62b7036d-76ad-4017-b5d7-17a259cf1823.html,,,,,, Reaction product of 4-aminophenol with 2-ethyl-6-methylbenzenamine and sodium polysulfide,1040873-93-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d018af3-7d7a-4daf-a342-ce58aebd7804/documents/d8666264-4700-41d0-8469-ba3156086ad7_62b7036d-76ad-4017-b5d7-17a259cf1823.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Reaction product of resin acid and rosin acid, 12-Hydroxyoctadecanoic and stearic acid with dipentaerythritol",208126-52-7, one Guideline study on acute toxicity by oral route and one Guideline study on acute toxicity by dermal route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8c0abb1-2236-4559-8e55-4b26656476fc/documents/1fd1afa3-6053-45b1-9844-445e2c76cc37_0d3f3e87-cddd-4f87-abf7-ebb013b21d0d.html,,,,,, "Reaction product of resin acid and rosin acid, 12-Hydroxyoctadecanoic and stearic acid with dipentaerythritol",208126-52-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8c0abb1-2236-4559-8e55-4b26656476fc/documents/1fd1afa3-6053-45b1-9844-445e2c76cc37_0d3f3e87-cddd-4f87-abf7-ebb013b21d0d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction product of resin acid and rosin acid, 12-Hydroxyoctadecanoic and stearic acid with dipentaerythritol",208126-52-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8c0abb1-2236-4559-8e55-4b26656476fc/documents/1fd1afa3-6053-45b1-9844-445e2c76cc37_0d3f3e87-cddd-4f87-abf7-ebb013b21d0d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Reaction product of salicylaldehyde and formaldehyde and phenol,304859-44-7," Acute toxicity: oral. Zelenák (2018) Under the conditions of this study, the acute oral LD50 value of the test material was found to be between 300 and 2000 mg/kg bw in female CRL:(WI) rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c7d67df-be2b-448e-9b3a-d826d7c63741/documents/ff23a9b4-ce36-4839-8276-bfed7b920984_6b007497-04e9-41fc-ae07-e970162197b9.html,,,,,, "Reaction product of the esterification of diglycerol with decanoic acid (Old name: 1,2,3-Propanetriol, homopolymer, decanoate)",74504-65-7," No studies are available for Polyglycerol-2-caprate. Data were therefore obtained for the group of polyglyceryl fatty acid esters, the relevant hydrolysis products and structural analogues. In the rat studies the animals were exposed to polyglycerol esters of fatty acids for 90 days and 22 weeks, respectively (EFSA, 2017b). No toxicity was seen in any of the studies. In humans, 19-24 years of aged, exposed for 3 weeks to polyglycerol esters of fatty acids though the diet, no signs of toxicity were seen (EFSA, 2017b). Three studies on mixtures of triglycerides were performed in rats. This was two 90-day studies and one 2 generation study. No adverse effects caused by decanoic acid and octanoic acid in form of medium-chain triglycerides was found. The NOAEL based on these studies was ≥ 7000 mg/kg bw/day (CLH report octanoic acid, 2012). For medium and long chain triglycerides, the NOAEL is reported to be ≥ 8000 mg/kg bw/day (Zhouet al., 2017). For the fatty acids, a NOAEL for decanoic acid is reported to be > 1000 mg/kg bw/day (CAR Capric acid, 2013). One study was performed on tetra decanoic acid (Lauric acid) in rats reporting a NOEL of > 6000 mg/kg/day (Burdocket al., 2007). Studies on repeated dose toxicity on synthetic and natural glycerine fed orally to rats is reported with a NOAEL of 10 000 mg/kg bw/d (ECHA, 2018) indicating that the glycerols are non-toxic. Based on the available studies on the group of polyglyceryl fatty acid esters and the relevant hydrolysis products described above, it can based on an overall weight of evidence approach be concluded that the compound Polyglycerol-2-caprate is of very low concern for repeated dose toxicity. Thus, no STOT RE classification should apply for the substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fdd0a07f-86ce-4661-beb9-4fcaf5653048/documents/fd702088-998b-44b8-bfa8-d0b33ad78165_52bfb73c-3e7e-42a2-9d12-697bcea1098e.html,,,,,, "Reaction product of the esterification of diglycerol with decanoic acid (Old name: 1,2,3-Propanetriol, homopolymer, decanoate)",74504-65-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fdd0a07f-86ce-4661-beb9-4fcaf5653048/documents/f3de3342-cca1-4c76-b3dc-280baea5b160_52bfb73c-3e7e-42a2-9d12-697bcea1098e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction product of the esterification of diglycerol with decanoic acid (Old name: 1,2,3-Propanetriol, homopolymer, decanoate)",74504-65-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fdd0a07f-86ce-4661-beb9-4fcaf5653048/documents/f3de3342-cca1-4c76-b3dc-280baea5b160_52bfb73c-3e7e-42a2-9d12-697bcea1098e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "reaction products of 1 mole of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs and 1 mole of cyclohexylamine",2060540-82-9," An acute oral toxicity study in rats (OECD 423) is available for Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs., compds. with cyclohexylamine. The acute oral LD50 value of this substance was found to be greater than 2000 mg active ingredient/kg bw in female Crl:WIrats. There are no data for dermal route and inhalation. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78d93872-b5b6-4563-bd80-178ee9353477/documents/406f30ba-567f-4f85-a4a1-8e0ed0451118_2d4c9854-032f-43af-aece-bbb6441faf10.html,,,,,, "reaction products of 1 mole of Benzenesulfonic acid, 4-C10-13-sec-alkyl derivs and 1 mole of cyclohexylamine",2060540-82-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78d93872-b5b6-4563-bd80-178ee9353477/documents/406f30ba-567f-4f85-a4a1-8e0ed0451118_2d4c9854-032f-43af-aece-bbb6441faf10.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction products of 1,4-Benzenedimethanol and 1-naphthol",113601-85-7, Acute Oral: The acute oral LD50 value of the test item SN-475N was found to be above 2000 mg/kg bw in female CRL:(WI) rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b7f8d74-2b4a-467a-8585-1aff61ff8a9d/documents/5db27755-0256-4fb5-bde5-ddeb0999f99c_870f215c-9ab2-45f0-8c86-d60c408ff610.html,,,,,, "Reaction products of 1,4-Benzenedimethanol and 1-naphthol",113601-85-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b7f8d74-2b4a-467a-8585-1aff61ff8a9d/documents/5db27755-0256-4fb5-bde5-ddeb0999f99c_870f215c-9ab2-45f0-8c86-d60c408ff610.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, reaction products of 2-Propenoic acid (2 moles) and Neopentylglycol hydroxypivalate (1 mole),2136366-99-7," A combined Repeated dose toxicity study with the Reproduction/Developmental toxicity study is available on the registered substance. Based on the dose-range finding study, a maximal dose of 600 mg/kg/day was chosen for the main OECD 422 study. No adverse toxicity was observed in parental animal, on reproduction parameters and on foetal development at 600 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80260d9d-94cb-441c-9535-8440c1a7bec1/documents/5d2dd068-be9a-4551-be92-1a57d8d971aa_e0b58dca-8d4f-4477-bd64-22d463467bd3.html,,,,,, reaction products of 2-Propenoic acid (2 moles) and Neopentylglycol hydroxypivalate (1 mole),2136366-99-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80260d9d-94cb-441c-9535-8440c1a7bec1/documents/5d2dd068-be9a-4551-be92-1a57d8d971aa_e0b58dca-8d4f-4477-bd64-22d463467bd3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat reaction products of 2-Propenoic acid (2 moles) and Neopentylglycol hydroxypivalate (1 mole),2136366-99-7,"The acute toxicity of the registered substance has been evaluated for the oral and dermal route. The oral study available showed no mortality or adverse systemic toxicity at the limit dose of 2000 mg/kg bw in rats. In the three dermal studies, no mortality or adverse systemic toxicity at the limit dose of 2000 mg/kg bw were observed in rats. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The key study is considered to be reliable with a klimish of 1. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The key and supporting studies are considered to be reliable with a klimish of 1. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80260d9d-94cb-441c-9535-8440c1a7bec1/documents/f3283ed3-f61d-4f08-9e24-f7852107d04b_e0b58dca-8d4f-4477-bd64-22d463467bd3.html,,,,,, reaction products of 2-Propenoic acid (2 moles) and Neopentylglycol hydroxypivalate (1 mole),2136366-99-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80260d9d-94cb-441c-9535-8440c1a7bec1/documents/f3283ed3-f61d-4f08-9e24-f7852107d04b_e0b58dca-8d4f-4477-bd64-22d463467bd3.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, reaction products of 2-Propenoic acid (2 moles) and Neopentylglycol hydroxypivalate (1 mole),2136366-99-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80260d9d-94cb-441c-9535-8440c1a7bec1/documents/f3283ed3-f61d-4f08-9e24-f7852107d04b_e0b58dca-8d4f-4477-bd64-22d463467bd3.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Reaction products of 3,3'-thiodi(propionic acid) and alcohols, C11-14-iso-, C13-rich",1034820-43-3,- NOEL > 5000 mg/kg bw/day (actual dose received) - The compound is relatively non-toxic in concentrations up to 3 % in the daily food of rats over an eight-month period. NOAEL was not determined. - NOAEL (maternal toxicity) = 1600 mg/kg bw/day - NOAEL not reported. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c8236317-b6ff-4f08-ade0-7581b696733e/documents/7ea52710-9863-41ad-89a6-0f52a20e2ae9_d33e2e90-ea7e-42d4-b9df-cc60fc3ddc06.html,,,,,, "Reaction products of 3,3'-thiodi(propionic acid) and alcohols, C11-14-iso-, C13-rich",1034820-43-3,LD50 (oral) > 2000 mg/kg bw. LD50 (dermal) > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8236317-b6ff-4f08-ade0-7581b696733e/documents/3c11e666-2220-420b-b006-a25c28aff9f6_d33e2e90-ea7e-42d4-b9df-cc60fc3ddc06.html,,,,,, "Reaction products of 3,3'-thiodi(propionic acid) and alcohols, C11-14-iso-, C13-rich",1034820-43-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8236317-b6ff-4f08-ade0-7581b696733e/documents/3c11e666-2220-420b-b006-a25c28aff9f6_d33e2e90-ea7e-42d4-b9df-cc60fc3ddc06.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Reaction products of 3,3'-thiodi(propionic acid) and alcohols, C11-14-iso-, C13-rich",1034820-43-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8236317-b6ff-4f08-ade0-7581b696733e/documents/3c11e666-2220-420b-b006-a25c28aff9f6_d33e2e90-ea7e-42d4-b9df-cc60fc3ddc06.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction products of 3-aminomethyl-3,5,5-trimethylcyclohexylamine with 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane",68609-08-5," The test item was tested in a 28-day subchronic repeated dose study according to EU Method B.7 (Repeated Dose (28 Days) Toxicity, Oral). The test item caused no adverse toxic effects in male or female CRL:(WI) BR rats after 28-day subsequent oral (by gavage) administration of 25 mg/kg bw/day, 80 mg/kg bw/day or 200 mg/kg bw/day. The no observed effect level (NOEL) was 25 mg/kg bw/day. The no observed adverse effect level (NOAEL) was 200 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79b48fa1-1c40-47d4-95fa-3c5b52742d08/documents/a250fd8d-acab-4b18-8d06-14fd539f5388_183f3c25-1d15-4bb4-806b-4a006df709d3.html,,,,,, "Reaction products of 3-aminomethyl-3,5,5-trimethylcyclohexylamine with 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane",68609-08-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79b48fa1-1c40-47d4-95fa-3c5b52742d08/documents/a250fd8d-acab-4b18-8d06-14fd539f5388_183f3c25-1d15-4bb4-806b-4a006df709d3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Reaction products of 3-aminomethyl-3,5,5-trimethylcyclohexylamine with 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane",68609-08-5," Oral The test item was tested for oral toxicity in rats according to OECD Guideline 423. The test substance caused mortality at 2000 mg/kg bw (3/3) and at 300 mg/kg bw (1/6). The acute oral LD50 value of the test item was between 300 mg/kg bw and 2000 mg/kg bw in female CRL:(WI) BR rats and it was ranked into Category 4. Dermal The test item was tested for dermal toxicity in a 24-hrs single administration of 2000 mg/kg bw in male and in female CRL:(WI)BR rats according to OECD Guideline 402. The test material caused erosion, erythema and sloughing on the treated skin, which recovered within 2 - 13 days. Mortalities were not observed. The acute dermal LD50 value of the test item is greater than 2000 mg/kg bw in male and female CRL:(WI)BR rats. No classification and labelling for dermal toxicity is required according to Regulation 1272/2008/EC (CLP). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79b48fa1-1c40-47d4-95fa-3c5b52742d08/documents/cba0a38f-0718-4553-9153-daed6b9f6e43_183f3c25-1d15-4bb4-806b-4a006df709d3.html,,,,,, "Reaction products of 3-aminomethyl-3,5,5-trimethylcyclohexylamine with 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane",68609-08-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79b48fa1-1c40-47d4-95fa-3c5b52742d08/documents/cba0a38f-0718-4553-9153-daed6b9f6e43_183f3c25-1d15-4bb4-806b-4a006df709d3.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, "Reaction products of 3-aminomethyl-3,5,5-trimethylcyclohexylamine with 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane",68609-08-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79b48fa1-1c40-47d4-95fa-3c5b52742d08/documents/cba0a38f-0718-4553-9153-daed6b9f6e43_183f3c25-1d15-4bb4-806b-4a006df709d3.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Reaction products of 4-hydroxy-2-butanone and ammonia and hydrogen,2867-59-6,"LD50(oral,rat): > 300 <2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e22f866-9b46-4bbd-a9ce-9bc427b0242f/documents/IUC5-ffc72b2c-559c-4db7-86f2-cc49426d9039_8de78a74-d12f-4a43-9835-b43e00761f64.html,,,,,, Reaction products of 4-hydroxy-2-butanone and ammonia and hydrogen,2867-59-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e22f866-9b46-4bbd-a9ce-9bc427b0242f/documents/IUC5-ffc72b2c-559c-4db7-86f2-cc49426d9039_8de78a74-d12f-4a43-9835-b43e00761f64.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "Reaction products of acrylic acid with 2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]",1393932-71-2," Based on the study results, the NOAEL for systemic effects was considered to be the highest tested dose level, i.e., 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/517f9dc3-4ac9-438a-b604-912d1a4f3b91/documents/IUC5-d9a94411-4cae-43d8-829a-7c529122917b_f7f69fe6-6db7-461a-af9d-e8475d318f8b.html,,,,,, "Reaction products of acrylic acid with 2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]",1393932-71-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/517f9dc3-4ac9-438a-b604-912d1a4f3b91/documents/IUC5-d9a94411-4cae-43d8-829a-7c529122917b_f7f69fe6-6db7-461a-af9d-e8475d318f8b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Reaction products of acrylic acid with 2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]",1393932-71-2," Based on the study results, the acute oral LD50 of the test substance was determined to be 5000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/517f9dc3-4ac9-438a-b604-912d1a4f3b91/documents/IUC5-5653410d-a4e2-4693-8f28-dab793fefd77_f7f69fe6-6db7-461a-af9d-e8475d318f8b.html,,,,,, "Reaction products of acrylic acid with 2,2'-[oxybis(methylene)]bis[2-ethylpropane-1,3-diol]",1393932-71-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/517f9dc3-4ac9-438a-b604-912d1a4f3b91/documents/IUC5-5653410d-a4e2-4693-8f28-dab793fefd77_f7f69fe6-6db7-461a-af9d-e8475d318f8b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Reaction products of diazotised 2-amino-1,5-naphthalene sulfonic acid coupled with resorcinol, subsequently coupled with diazotized 2-amino-4,6-dinitrophenol, chelated with iron",61967-98-4, Rat: LD50 (m/f) > 2200 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d21f2fb2-4240-4ee4-bd43-e3e897d0230a/documents/e0c31506-6557-4220-ac9e-152ff94d2cca_3c9284ad-450b-4e35-80cf-82c35e688be6.html,,,,,, "Reaction products of diazotised 2-amino-1,5-naphthalene sulfonic acid coupled with resorcinol, subsequently coupled with diazotized 2-amino-4,6-dinitrophenol, chelated with iron",61967-98-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d21f2fb2-4240-4ee4-bd43-e3e897d0230a/documents/e0c31506-6557-4220-ac9e-152ff94d2cca_3c9284ad-450b-4e35-80cf-82c35e688be6.html,,oral,LD50,"2,200 mg/kg bw",no adverse effect observed, "Reaction products of diazotised 4'-aminoazobenzene-4-sulphonic acid, coupled with resorcinol and diazotised sodium 4-aminobenzenesulfonate, sodium salts",61931-07-5," LD50 (oral, rat) > 5000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8e4e79d-89ba-48d8-820f-cbc6f16c9e0b/documents/187b755a-a8b5-414b-8663-231f4ba57524_6d978883-dc66-4806-b3b0-fa56f51a2545.html,,,,,, "Reaction products of diazotised 4'-aminoazobenzene-4-sulphonic acid, coupled with resorcinol and diazotised sodium 4-aminobenzenesulfonate, sodium salts",61931-07-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8e4e79d-89ba-48d8-820f-cbc6f16c9e0b/documents/187b755a-a8b5-414b-8663-231f4ba57524_6d978883-dc66-4806-b3b0-fa56f51a2545.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Reaction products of diazotised 5-amino-2-anilinobenzenesulphonic acid coupled with resorcinol, subsequently coupled with diazotised 3-amino-4-hydroxy-5-nitrobenzenesulphonic acid, subsequently coupled with diazotised sodium 2-amino-4,6-dinitrophenoxide, subsequently coupled with diazotised 4-nitroaniline, sodium salts",12219-56-6," LD50 (oral, rat) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f665d013-28cc-4e3c-ab2b-83dcef2a12b3/documents/3b6ec1f5-6373-4892-bed3-88da378ba965_42879fb5-36ec-4985-84b5-56d975ba7a02.html,,,,,, "Reaction products of diazotised 5-amino-2-anilinobenzenesulphonic acid coupled with resorcinol, subsequently coupled with diazotised 3-amino-4-hydroxy-5-nitrobenzenesulphonic acid, subsequently coupled with diazotised sodium 2-amino-4,6-dinitrophenoxide, subsequently coupled with diazotised 4-nitroaniline, sodium salts",12219-56-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f665d013-28cc-4e3c-ab2b-83dcef2a12b3/documents/3b6ec1f5-6373-4892-bed3-88da378ba965_42879fb5-36ec-4985-84b5-56d975ba7a02.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Reaction products of diazotized disodium 4-amino-3,6-bis[(4-aminophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate, coupled with m-phenylenediamine",1793011-72-9,"The oral LD50 value of the test substance in Wistar rats was established to exceed 2000 mg/kg body weight. According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f51561fe-4999-4f37-a9b2-0ac0e9ce75e3/documents/1a41316c-e83f-4f8c-a1c0-a0cfc4b781c6_253ef0eb-a2f8-4ba1-945a-75b27d2ee0e1.html,,,,,, "Reaction products of diazotized disodium 4-amino-3,6-bis[(4-aminophenyl)azo]-5-hydroxynaphthalene-2,7-disulphonate, coupled with m-phenylenediamine",1793011-72-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f51561fe-4999-4f37-a9b2-0ac0e9ce75e3/documents/1a41316c-e83f-4f8c-a1c0-a0cfc4b781c6_253ef0eb-a2f8-4ba1-945a-75b27d2ee0e1.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "reaction products of Fatty acids, C16-18 and C18-unsatd (2 moles) with tetraethylenepentamine (1 mole)",1226892-46-1," A combined repeated dose/reproduction screening toxicity study according to OECD 422 with Fatty acids, C18 unsat, reaction products with diethylenetriamine (AAI-DETA) resulted to a NOAEL of 10 mg/kg bw/day based on the increased incidence/severity of macrophage foci in the mesenteric lymph node observed at 30 or 100 mg/kg bw/day, the highest dose tested. All already available data from the group of AAI substances, including 90 -day studies in rat and dogs on a similar substance, also indicate low repeated dose toxicity. The 90-day NOAEL with AAI-DETA is considered to be 10 mg/kg bw/d. At higher dose levels an increase of the presence of foamy macrophages in the lamina propria of the small intestines and mesenteric lymph nodes is observed, as well as lower mean body weight and body weight gain, especially in the males, with lower food intake, essentially during the second half of the treatment period. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/66e0f565-b126-4943-b040-c544f0d50329/documents/689d4859-cd33-44c3-9833-d848ed0ba549_4c1716f9-cc1c-4f21-8cc6-d674c350430c.html,,,,,, "reaction products of Fatty acids, C16-18 and C18-unsatd (2 moles) with tetraethylenepentamine (1 mole)",1226892-46-1,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/66e0f565-b126-4943-b040-c544f0d50329/documents/689d4859-cd33-44c3-9833-d848ed0ba549_4c1716f9-cc1c-4f21-8cc6-d674c350430c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "reaction products of Fatty acids, C16-18 and C18-unsatd (2 moles) with tetraethylenepentamine (1 mole)",1226892-46-1," As for the substance itself no toxicological information is available, cross-reading has been applied to TO + DETA. Acute toxicity: Oral LD50 > 2000 mg/kg for rat (LD50 cut-off: 2500 mg/kg bw) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66e0f565-b126-4943-b040-c544f0d50329/documents/ead83478-9bc8-4bf7-9dac-0fab4ec33622_4c1716f9-cc1c-4f21-8cc6-d674c350430c.html,,,,,, "reaction products of Fatty acids, C16-18 and C18-unsatd (2 moles) with tetraethylenepentamine (1 mole)",1226892-46-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66e0f565-b126-4943-b040-c544f0d50329/documents/ead83478-9bc8-4bf7-9dac-0fab4ec33622_4c1716f9-cc1c-4f21-8cc6-d674c350430c.html,,oral,LD50,"2,500 mg/kg bw",, "Reaction products of hexane-1,6-diol with 2-(chloromethyl)oxirane (1:2)",933999-84-9," The oral administration of 1,6-hexanediol reaction product with chloromethyloxirane to rats for a period of ninety consecutive days, to Wistar rats of both sexes at dose levels of 30, 100 or 300 mg/kg bw/day resulted in treatment related effects in animals of either sex treated with 300 mg/kg bw/day. A No Observed Effect Level (NOEL) for systemic toxicity was considered to be 100 mg/kg bw/day for male animals; this could not be established in females due to the slight body weight effects noted at 30 mg/kg bw/day. The microscopic liver change evident in animals of either sex treated with 300 mg/kg bw/day was considered to be an adaptive response to treatment and as such is considered to be non-adverse in nature. The stomach findings of ulceration or erosion and hyperplasia including hyperkeratosis (to varying degrees of severity) were noted in animals of either sex treated with 300 mg/kg bw/day and could be considered an adverse effect. However, these findings are likely to reflect an irritant effect of the test item on the non-glandular mucosa and are considered not to be relevant for humans as the unique structure of the rodent’s stomach is considered to have led to a prolonged exposure to the test item and the corresponding anatomical area is not present in man. In terms of risk assessment, the findings observed on this study would suggest that a No Observed Adverse Effect Level (NOAEL) can be established at 300 mg/kg bw/day for animals of either sex because the findings in general do not reflect true systemic toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/498dabef-819b-4425-81ef-939a2ffb9317/documents/IUC5-c3124e42-94d1-45ee-aa78-92b3ce0b22d7_17e357ae-3398-495f-91e3-581ee35028ad.html,,,,,, "Reaction products of hexane-1,6-diol with 2-(chloromethyl)oxirane (1:2)",933999-84-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/498dabef-819b-4425-81ef-939a2ffb9317/documents/IUC5-c3124e42-94d1-45ee-aa78-92b3ce0b22d7_17e357ae-3398-495f-91e3-581ee35028ad.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,16 mg/m3,,rat "Reaction products of hexane-1,6-diol with 2-(chloromethyl)oxirane (1:2)",933999-84-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/498dabef-819b-4425-81ef-939a2ffb9317/documents/IUC5-c3124e42-94d1-45ee-aa78-92b3ce0b22d7_17e357ae-3398-495f-91e3-581ee35028ad.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Reaction products of hexane-1,6-diol with 2-(chloromethyl)oxirane (1:2)",933999-84-9,"1,6-Hexanediol Diglycidylether (HDDGE) was evaluated for acute oral, dermal and inhalation toxicity by O.E.C.D. Testing Guideline studies conducted with GLP compliance. HDDGE was relatively non-toxic by all routes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/498dabef-819b-4425-81ef-939a2ffb9317/documents/IUC5-ce3dd9fd-f800-49fb-8462-95f54ae9116a_17e357ae-3398-495f-91e3-581ee35028ad.html,,,,,, "Reaction products of hexane-1,6-diol with 2-(chloromethyl)oxirane (1:2)",933999-84-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/498dabef-819b-4425-81ef-939a2ffb9317/documents/IUC5-ce3dd9fd-f800-49fb-8462-95f54ae9116a_17e357ae-3398-495f-91e3-581ee35028ad.html,,oral,LD50,"2,190 mg/kg bw",, "Reaction products of m-phenylenebis(methylamine) with 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane",110839-13-9," The test item  was tested in a 28-day subchronic repeated dose study according to EU Method B.7 (Repeated Dose (28 Days) Toxicity, Oral). The no observed adverse effect level (NOAEL) was 200 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1ec15b7-66b7-4d0f-bc41-cb0bedc6fab6/documents/1ad0d120-45f9-4b30-85e7-eaaf4f372946_e74c6d24-67d8-4e74-bc46-b8cb34c31cbe.html,,,,,, "Reaction products of m-phenylenebis(methylamine) with 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane",110839-13-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1ec15b7-66b7-4d0f-bc41-cb0bedc6fab6/documents/1ad0d120-45f9-4b30-85e7-eaaf4f372946_e74c6d24-67d8-4e74-bc46-b8cb34c31cbe.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Reaction products of m-phenylenebis(methylamine) with 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane",110839-13-9, Oral The test item was tested for oral toxicity in rats according to OECD Guideline 423. The acute oral LD50 value of the test item was between 300 mg/kg bw and 2000 mg/kg bw in female CRL:WI (BR) rats and it was ranked into Category 4. Dermal The test item was tested for dermal toxicity in a 24-hrs single administration of 2000 mg/kg bw in male and female CRL:(WI) BR rats according to OECD Guideline 402. The acute dermal LD50 of the test item is greater than 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1ec15b7-66b7-4d0f-bc41-cb0bedc6fab6/documents/58776a58-9330-4377-9d83-c5f9680d2985_e74c6d24-67d8-4e74-bc46-b8cb34c31cbe.html,,,,,, "Reaction products of m-phenylenebis(methylamine) with 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane",110839-13-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1ec15b7-66b7-4d0f-bc41-cb0bedc6fab6/documents/58776a58-9330-4377-9d83-c5f9680d2985_e74c6d24-67d8-4e74-bc46-b8cb34c31cbe.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, "Reaction products of m-phenylenebis(methylamine) with 2,2'-[(1-methylethylidene)bis(4,1-phenyleneoxymethylene)]bisoxirane",110839-13-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1ec15b7-66b7-4d0f-bc41-cb0bedc6fab6/documents/58776a58-9330-4377-9d83-c5f9680d2985_e74c6d24-67d8-4e74-bc46-b8cb34c31cbe.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Reaction products of N,N'-ethane-1,2-diylbis(1,3-propanediamine), cyclohexane, peroxidized 4-butylamino-2,2,6,6-tetramethylpiperidine and 2,4,6-trichloro-1,3,5-triazine",191680-81-6,"In a subacute study with rats (Covance, 1997) the test substance did not cause any adverse effects up to the highest dose tested (1000 mg/kg), therefore, the NOAEL was set at 1000 mg/kg bw.In a subchronic study with rats (BASF SE, 2022) the test substance did not cause any adverse effects up to the highest dose tested (1000 mg/kg), therefore, the NOAEL was set at 1000 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a2836cd-df90-4b40-8a91-cec2405cb2a1/documents/IUC5-14e8d28e-6985-4edb-99af-b7d49284e71a_56ff98e9-9ec2-4275-96ed-432c0ac4b1ab.html,,,,,, "Reaction products of N,N'-ethane-1,2-diylbis(1,3-propanediamine), cyclohexane, peroxidized 4-butylamino-2,2,6,6-tetramethylpiperidine and 2,4,6-trichloro-1,3,5-triazine",191680-81-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a2836cd-df90-4b40-8a91-cec2405cb2a1/documents/IUC5-14e8d28e-6985-4edb-99af-b7d49284e71a_56ff98e9-9ec2-4275-96ed-432c0ac4b1ab.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Reaction products of N,N'-ethane-1,2-diylbis(1,3-propanediamine), cyclohexane, peroxidized 4-butylamino-2,2,6,6-tetramethylpiperidine and 2,4,6-trichloro-1,3,5-triazine",191680-81-6,"The LD50 values in rats for acute oral exposure and in rabbits for acute dermal exposure to the test substance are >5000 mg/kg bw and >2000 mg/kg bw, respectively. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a2836cd-df90-4b40-8a91-cec2405cb2a1/documents/IUC5-6ae34a98-ce78-4f0b-96eb-fbd4e53195e0_56ff98e9-9ec2-4275-96ed-432c0ac4b1ab.html,,,,,, "Reaction products of N,N'-ethane-1,2-diylbis(1,3-propanediamine), cyclohexane, peroxidized 4-butylamino-2,2,6,6-tetramethylpiperidine and 2,4,6-trichloro-1,3,5-triazine",191680-81-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a2836cd-df90-4b40-8a91-cec2405cb2a1/documents/IUC5-6ae34a98-ce78-4f0b-96eb-fbd4e53195e0_56ff98e9-9ec2-4275-96ed-432c0ac4b1ab.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Reaction products of N,N'-ethane-1,2-diylbis(1,3-propanediamine), cyclohexane, peroxidized 4-butylamino-2,2,6,6-tetramethylpiperidine and 2,4,6-trichloro-1,3,5-triazine",191680-81-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a2836cd-df90-4b40-8a91-cec2405cb2a1/documents/IUC5-6ae34a98-ce78-4f0b-96eb-fbd4e53195e0_56ff98e9-9ec2-4275-96ed-432c0ac4b1ab.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3,5-Triazine-2,4,6-triamine, N2,N2’-1,6-hexanediylbis[N4,N6-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethyl-4-piperidinyl)-, N-allyl derivs., oxidized, hydrogenated",1902936-62-2,OECD 408 - NOAEL >= 1000 mg/kg bw/d (no adverse effects observed) OECD 422 - NOAEL >= 1000 mg/kg bw/d (no adverse effects observed) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2475d16-9983-4caf-9e81-ae6656abd0ef/documents/edcc8bce-d5a8-4015-a656-f3568f528d71_1a0f7a39-9647-4013-95ef-5862115ec208.html,,,,,, "1,3,5-Triazine-2,4,6-triamine, N2,N2’-1,6-hexanediylbis[N4,N6-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethyl-4-piperidinyl)-, N-allyl derivs., oxidized, hydrogenated",1902936-62-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2475d16-9983-4caf-9e81-ae6656abd0ef/documents/edcc8bce-d5a8-4015-a656-f3568f528d71_1a0f7a39-9647-4013-95ef-5862115ec208.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,3,5-Triazine-2,4,6-triamine, N2,N2’-1,6-hexanediylbis[N4,N6-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethyl-4-piperidinyl)-, N-allyl derivs., oxidized, hydrogenated",1902936-62-2,"The substance did not cause adverse effects upon 14 -day gavage dosing with 1000 mg/kg bw. Therefore, it is not necessary to perform an additional study for acute oral toxicity with 2000 mg/kg bw.  The substance was tested in the acute dermal toxicity study (OECD 402, GLP) using corn oil as vehicle. No mortality was observed, but there were local reactions which occurred with a time delay. A study for acute inhalation was not performed because the substance is not handled in an inhalable form. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2475d16-9983-4caf-9e81-ae6656abd0ef/documents/2bf0d2a7-ce66-461d-94aa-63fd437a2841_1a0f7a39-9647-4013-95ef-5862115ec208.html,,,,,, "1,3,5-Triazine-2,4,6-triamine, N2,N2’-1,6-hexanediylbis[N4,N6-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethyl-4-piperidinyl)-, N-allyl derivs., oxidized, hydrogenated",1902936-62-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2475d16-9983-4caf-9e81-ae6656abd0ef/documents/2bf0d2a7-ce66-461d-94aa-63fd437a2841_1a0f7a39-9647-4013-95ef-5862115ec208.html,,oral,discriminating dose,"1,000 mg/kg bw",no adverse effect observed, "1,3,5-Triazine-2,4,6-triamine, N2,N2’-1,6-hexanediylbis[N4,N6-dibutyl-N2,N4,N6-tris(2,2,6,6-tetramethyl-4-piperidinyl)-, N-allyl derivs., oxidized, hydrogenated",1902936-62-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2475d16-9983-4caf-9e81-ae6656abd0ef/documents/2bf0d2a7-ce66-461d-94aa-63fd437a2841_1a0f7a39-9647-4013-95ef-5862115ec208.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Reaction products of phosphoryl trichloride and 2-methyloxirane,1244733-77-4,"OECD 407 (Leser, Bayer AG, 1991): 28d NOAEL = 100 mg/kg bw/dayOECD 408 (equiv.) (Stauffer Chemical Co., 1981): 90d LOAEL = 52 mg/kg bw/dayNational Toxicology Programme: 3 month mouse study high dose levels (used to support the Carcinogencity study)Males: 1050 mg/kg/day; Females: 1841 mg/kg/dayNational Toxicology Programme: 3 month rat study high dose levels (used to support the Carcinogencity study):1890 mg/kg/dayHazards identified by EU Risk Assessment in May 2008:- A 13 week feeding study in rats indicated liver and thyroid as the main target organs affected by TCPP. A LOAEL of 52 mg/kg/day is derived for this study. - In a 2-generation reproductive toxicity study in which rats were fed TCPP in the diet over two successive generations, the low-dose of 99 mg/kg for females is considered to be the LOAEL for parental toxicity.No data are available on inhalation and dermal repeated dose toxicity. Key studies are submitted for sub-acute and sub-chronic toxicity, in accordance with Annexes VIII and IX of REACH. They are also supported by observations from a 2-generation reproductive toxicity study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcdbfb2b-9ee0-44d2-b347-f10121b4e478/documents/5fa19923-8232-4d73-b1eb-ce3a3a0cc9ce_929d879c-5164-4c71-9026-c8ebdd04209f.html,,,,,, Reaction products of phosphoryl trichloride and 2-methyloxirane,1244733-77-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcdbfb2b-9ee0-44d2-b347-f10121b4e478/documents/5fa19923-8232-4d73-b1eb-ce3a3a0cc9ce_929d879c-5164-4c71-9026-c8ebdd04209f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Reaction products of phosphoryl trichloride and 2-methyloxirane,1244733-77-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcdbfb2b-9ee0-44d2-b347-f10121b4e478/documents/5fa19923-8232-4d73-b1eb-ce3a3a0cc9ce_929d879c-5164-4c71-9026-c8ebdd04209f.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,52 mg/kg bw/day,,rat Reaction products of phosphoryl trichloride and 2-methyloxirane,1244733-77-4,"Key Studies:OECD 401 (Stropp, Bayer AG, 1996): LD50 = 632 mg/kg bw (Acute Tox. 4)OECD 403 (IRI 1990a): LC50 = > 7 mg/L (not classified)OECD 402 (IRI 1989b): LD50 = > 2,000 mg/kg bw (not classified)Hazards identified by EU Risk Assessment in May 2008-TCPP is of moderate toxicity via the oral route of exposure, with LD50 values from the better quality studies ranging from 632 mg/kg up to 4200 mg/kg, with the majority of values determined to be 2000 mg/kg.-TCPP is of low toxicity via the inhalation route.-There is no concern for acute delayed neurotoxicity for TCPP.-TCPP is of low t oxicity via the dermal route of exposure. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Data rich endpoint, with multiple reliable studies. The key study was chosen based on the lowest LD50 value. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Two reliable studies available, meeting data requirements under Annex VIII of REACH. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): A single key study is available (OECD 402) that meets information requirements under Annex VIII of REACH. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcdbfb2b-9ee0-44d2-b347-f10121b4e478/documents/722f192e-429e-4027-95c1-93c6a8d368c6_929d879c-5164-4c71-9026-c8ebdd04209f.html,,,,,, Reaction products of phosphoryl trichloride and 2-methyloxirane,1244733-77-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcdbfb2b-9ee0-44d2-b347-f10121b4e478/documents/722f192e-429e-4027-95c1-93c6a8d368c6_929d879c-5164-4c71-9026-c8ebdd04209f.html,,oral,LD50,632 mg/kg bw,adverse effect observed, Reaction products of phosphoryl trichloride and 2-methyloxirane,1244733-77-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcdbfb2b-9ee0-44d2-b347-f10121b4e478/documents/722f192e-429e-4027-95c1-93c6a8d368c6_929d879c-5164-4c71-9026-c8ebdd04209f.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Reaction products of phosphoryl trichloride and 2-methyloxirane,1244733-77-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcdbfb2b-9ee0-44d2-b347-f10121b4e478/documents/722f192e-429e-4027-95c1-93c6a8d368c6_929d879c-5164-4c71-9026-c8ebdd04209f.html,,inhalation,LC50,> 7 mg/L,no adverse effect observed, "Reaction products of propane-1,2-diamine with 2-[(2-methylphenoxy)methyl]oxirane",1802886-42-5,The acute oral LD50 was determined to be between 300 mg/kg bw and 2000 mg/kg bw in rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/737de36b-e8c6-4b9b-9522-802e1dcae75c/documents/0b01162b-176f-42c8-864a-5e71b78599ce_1f1995d6-b603-4aca-a2e8-c4456f8435a4.html,,,,,, "Reaction products of propane-1,2-diamine with 2-[(2-methylphenoxy)methyl]oxirane",1802886-42-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/737de36b-e8c6-4b9b-9522-802e1dcae75c/documents/0b01162b-176f-42c8-864a-5e71b78599ce_1f1995d6-b603-4aca-a2e8-c4456f8435a4.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, "1,2-Benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, mixed esters with diethylene glycol and propylene glycol",77098-07-8,"OECD 408, GLP, oral, rat, NOAEL = 1000 mg/kg bw/d OECD 422, GLP, oral, rat, NOAEL = 1000 mg/kg bw/d ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/958cbd63-2dbc-4972-be3a-24b3084b853f/documents/384827a9-0779-409c-b1bb-6f727a0c49f4_5db01687-c28f-4e2f-9b16-25c3c896ac83.html,,,,,, "1,2-Benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, mixed esters with diethylene glycol and propylene glycol",77098-07-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/958cbd63-2dbc-4972-be3a-24b3084b853f/documents/384827a9-0779-409c-b1bb-6f727a0c49f4_5db01687-c28f-4e2f-9b16-25c3c896ac83.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,2-Benzenedicarboxylic acid, 3,4,5,6-tetrabromo-, mixed esters with diethylene glycol and propylene glycol",77098-07-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/958cbd63-2dbc-4972-be3a-24b3084b853f/documents/384827a9-0779-409c-b1bb-6f727a0c49f4_5db01687-c28f-4e2f-9b16-25c3c896ac83.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Reaction products of Cuprate(3-), [2-amino-5-(hydroxy-κO)-6-[2-[2-[2-[2-(hydroxy-κO)-5-sulfophenyl]diazenyl-κN1]-4,5-dimethoxyphenyl]diazenyl-κN1]-1,7-naphthalenedisulfonato(5-)]-, sodium (1:3) with 2,4,6-trifluoro-1,3,5-triazine subsequently condensed with Ethanol, 2-[[2-(methylamino)ethyl]sulfonyl]-, 1-(hydrogen sulfate)",479541-17-8,"In a GLP guideline study for subacute oral toxicity in Sprague Dawley rats, the only effects seen were secondary effects due to the fluoride impurity, which caused dental fluorosis in rats' teeth. A local, reversible, inflammation in the stomach, caused by a gavage effect due to the high salt concentration in the test material was considered not substance induced toxicity and hence toxicologically irrelevant. The NOAEL for subacute oral administration of Reactive Olive F00-0149 is 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4102123-974e-4882-af3b-0b320250ff81/documents/7d545b75-74c3-4c26-a510-cd611a647fab_382a429b-0278-4f18-b59a-2383e9fa3020.html,,,,,, "Reaction products of Cuprate(3-), [2-amino-5-(hydroxy-κO)-6-[2-[2-[2-[2-(hydroxy-κO)-5-sulfophenyl]diazenyl-κN1]-4,5-dimethoxyphenyl]diazenyl-κN1]-1,7-naphthalenedisulfonato(5-)]-, sodium (1:3) with 2,4,6-trifluoro-1,3,5-triazine subsequently condensed with Ethanol, 2-[[2-(methylamino)ethyl]sulfonyl]-, 1-(hydrogen sulfate)",479541-17-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4102123-974e-4882-af3b-0b320250ff81/documents/7d545b75-74c3-4c26-a510-cd611a647fab_382a429b-0278-4f18-b59a-2383e9fa3020.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Reaction products of Cuprate(3-), [2-amino-5-(hydroxy-κO)-6-[2-[2-[2-[2-(hydroxy-κO)-5-sulfophenyl]diazenyl-κN1]-4,5-dimethoxyphenyl]diazenyl-κN1]-1,7-naphthalenedisulfonato(5-)]-, sodium (1:3) with 2,4,6-trifluoro-1,3,5-triazine subsequently condensed with Ethanol, 2-[[2-(methylamino)ethyl]sulfonyl]-, 1-(hydrogen sulfate)",479541-17-8,An acute oral and dermal toxicity study were performed  in accordance with OECD 423 and EU Method B.1. (oral) and OECD 402 and EU Method B.3 (dermal). The resulting LD50 values were >2000 mg/kg bw. The test substance did not induce any toxic effects. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4102123-974e-4882-af3b-0b320250ff81/documents/ab8602f8-ffbd-4b30-9ccc-ffb40b8ef176_382a429b-0278-4f18-b59a-2383e9fa3020.html,,,,,, "Reaction products of Cuprate(3-), [2-amino-5-(hydroxy-κO)-6-[2-[2-[2-[2-(hydroxy-κO)-5-sulfophenyl]diazenyl-κN1]-4,5-dimethoxyphenyl]diazenyl-κN1]-1,7-naphthalenedisulfonato(5-)]-, sodium (1:3) with 2,4,6-trifluoro-1,3,5-triazine subsequently condensed with Ethanol, 2-[[2-(methylamino)ethyl]sulfonyl]-, 1-(hydrogen sulfate)",479541-17-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4102123-974e-4882-af3b-0b320250ff81/documents/ab8602f8-ffbd-4b30-9ccc-ffb40b8ef176_382a429b-0278-4f18-b59a-2383e9fa3020.html,,oral,LD0,">=2,000 mg/kg bw",no adverse effect observed, "Reaction products of Cuprate(3-), [2-amino-5-(hydroxy-κO)-6-[2-[2-[2-[2-(hydroxy-κO)-5-sulfophenyl]diazenyl-κN1]-4,5-dimethoxyphenyl]diazenyl-κN1]-1,7-naphthalenedisulfonato(5-)]-, sodium (1:3) with 2,4,6-trifluoro-1,3,5-triazine subsequently condensed with Ethanol, 2-[[2-(methylamino)ethyl]sulfonyl]-, 1-(hydrogen sulfate)",479541-17-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4102123-974e-4882-af3b-0b320250ff81/documents/ab8602f8-ffbd-4b30-9ccc-ffb40b8ef176_382a429b-0278-4f18-b59a-2383e9fa3020.html,,dermal,LD0,">=2,000 mg/kg bw",no adverse effect observed, "2-Butanamine, 1,1'-[(1-methylethylidene)bis(oxy)]bis-",2267262-14-4," Based on all the observations and results from read across studies and applying weight of evidence, it was concluded that the No Observed Adverse Effect Level (NOAEL) for the test chemical is considered to be 1000 mg / kg body weight when Wistar male and female rats were orally treated with test chemical. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/61eb0692-e654-40f9-b42b-e18bc69a3885/documents/d22b58b8-0ea0-4b90-8426-d129c5c9b808_4db5335c-47f0-4753-a589-950212e3bdcd.html,,,,,, "2-Butanamine, 1,1'-[(1-methylethylidene)bis(oxy)]bis-",2267262-14-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/61eb0692-e654-40f9-b42b-e18bc69a3885/documents/d22b58b8-0ea0-4b90-8426-d129c5c9b808_4db5335c-47f0-4753-a589-950212e3bdcd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "2-Butanamine, 1,1'-[(1-methylethylidene)bis(oxy)]bis-",2267262-14-4," On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism, the study does not nedd to be conducted because the substance is classified as corrosive to the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/61eb0692-e654-40f9-b42b-e18bc69a3885/documents/2c09577c-3bbb-450a-9f43-ea5282e5701b_4db5335c-47f0-4753-a589-950212e3bdcd.html,,,,,, "1,1'-[(1-methylethylidene)bis(oxy)]bis[2-methyl-2-propanamine]",1693772-61-0," Based on all the observations and results from read across studies and applying weight of evidence, it was concluded that the No Observed Adverse Effect Level (NOAEL) for the test chemical is considered to be 1000 mg / kg body weight when Wistar male and female rats were orally treated with test chemical. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f6b5cda-5b6c-4a65-9b64-e4ead23df318/documents/dacbc46b-f835-41ce-bef0-8bcde3f52afb_f6dc3966-6772-49b3-a915-406657d10753.html,,,,,, "1,1'-[(1-methylethylidene)bis(oxy)]bis[2-methyl-2-propanamine]",1693772-61-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2f6b5cda-5b6c-4a65-9b64-e4ead23df318/documents/dacbc46b-f835-41ce-bef0-8bcde3f52afb_f6dc3966-6772-49b3-a915-406657d10753.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "1,1'-[(1-methylethylidene)bis(oxy)]bis[2-methyl-2-propanamine]",1693772-61-0," On the basis of the experimental studies of the structurally and functionally similar read across chemical and applying the weight of evidence approach and by evaluating the effect of test chemical on test organism, the study does not nedd to be conducted because the substance is classified as corrosive to the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f6b5cda-5b6c-4a65-9b64-e4ead23df318/documents/a52e24a6-bfd1-45e5-816f-54000bf90b39_f6dc3966-6772-49b3-a915-406657d10753.html,,,,,, "Refractories, fibers, aluminosilicate",142844-00-6,Key Interpretation of the results from the repeated dose inhalation studies is limited due to particulate contamination of the fibre samples used ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1348306e-73c6-4d6f-bd52-4326e6ef47d4/documents/18f8dff5-76f8-477f-91f6-8fc4f037f29d_b7edb36c-b588-426b-9987-f705224de160.html,,,,,, "Refractories, fibers, aluminosilicate",142844-00-6,No man-made mineral fibre has shown acute toxic effects even after very large inhalation and instillation studies where physical damage was avoided. No treatment related lethality or acute damage to any organ system has been detected in chronic or sub chronic studies with the fibres under discussion in this dossier. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1348306e-73c6-4d6f-bd52-4326e6ef47d4/documents/fd510fdc-15a7-4e37-8279-38ffcf67c498_b7edb36c-b588-426b-9987-f705224de160.html,,,,,, "rel-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]hexan-3-ol",253454-23-8,"NOAEL (OECD TG 422): 4500 ppm (corresponding to an actual test article intake of 296 and 406 mg/kg/day for males and females, respectively)  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1d7e7ec-cfbe-4561-a93c-f44d1e3810d8/documents/0ae116cc-2af9-4c08-b987-dcf97c61b523_b68d2c85-da78-4616-b540-cbbce18d8755.html,,,,,, "rel-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]hexan-3-ol",253454-23-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e1d7e7ec-cfbe-4561-a93c-f44d1e3810d8/documents/0ae116cc-2af9-4c08-b987-dcf97c61b523_b68d2c85-da78-4616-b540-cbbce18d8755.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,296 mg/kg bw/day,,rat "rel-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]hexan-3-ol",253454-23-8,"Acute oral toxicity: The LD50 of Hysandol PRG is > 5000 mg/kg bw based on the read across from Nimberol, which was tested in an oral toxicity test.  Acute dermal toxicity: The LD50 of Hysandol PRG is > 2000 mg/kg bw based on the read across from Timberol, which was tested in an OECD TG 402 acute dermal toxicity study. Acute inhalation (route to route extrapolation): read-across from Nimberol: > 13000 mg/m3. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1d7e7ec-cfbe-4561-a93c-f44d1e3810d8/documents/5741173d-862b-45ec-b0b1-38cc5988460f_b68d2c85-da78-4616-b540-cbbce18d8755.html,,,,,, "rel-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]hexan-3-ol",253454-23-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1d7e7ec-cfbe-4561-a93c-f44d1e3810d8/documents/5741173d-862b-45ec-b0b1-38cc5988460f_b68d2c85-da78-4616-b540-cbbce18d8755.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, "rel-1-[(1R,6S)-2,2,6-trimethylcyclohexyl]hexan-3-ol",253454-23-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1d7e7ec-cfbe-4561-a93c-f44d1e3810d8/documents/5741173d-862b-45ec-b0b1-38cc5988460f_b68d2c85-da78-4616-b540-cbbce18d8755.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), hydrodesulfurized vacuum",64742-85-4,"Key acute oral (OECD 401), dermal (OECD 402), and inhalation (OECD 403) studies were identified.• The oral LD50 was > 5000 mg/kg bw in male and female rats for two petroleum vacuum residues.• The dermal LD50 was > 2000 mg/kg bw in male and female rabbits for two petroleum vacuum residues.• The LC50 was > 94.4 mg/m3 in male and female rats for fumes from oxidized (air-rectified) asphalt. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6fc85b4-5f5c-436a-9d83-b52a2461384b/documents/e690a326-d489-4230-962e-68962f5ed2e6_360b45f3-c302-4f29-b2c9-8242deb4f7fe.html,,,,,, "Residues (petroleum), hydrodesulfurized vacuum",64742-85-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6fc85b4-5f5c-436a-9d83-b52a2461384b/documents/e690a326-d489-4230-962e-68962f5ed2e6_360b45f3-c302-4f29-b2c9-8242deb4f7fe.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), hydrodesulfurized vacuum",64742-85-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6fc85b4-5f5c-436a-9d83-b52a2461384b/documents/e690a326-d489-4230-962e-68962f5ed2e6_360b45f3-c302-4f29-b2c9-8242deb4f7fe.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), hydrodesulfurized vacuum",64742-85-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6fc85b4-5f5c-436a-9d83-b52a2461384b/documents/e690a326-d489-4230-962e-68962f5ed2e6_360b45f3-c302-4f29-b2c9-8242deb4f7fe.html,,inhalation,LC50,94.4 mg/m3,no adverse effect observed, "Residues (petroleum), thermal cracked vacuum",92062-05-0," The following studies were identified: two read-across 28-day dermal studies (OECD 410); a 90-day inhalation study; and a read across chronic inhalation study (OECD 451). In addition a supporting inhalation study is available ( 14 days). In a combined repeat dose / reproductive screening study with oxidized asphalt, no significant effects were observed For the dermal studies performed on rabbits, the LOAEL topical effects for both samples of vacuum residue was 200 mg/kg/day and the NOAEL for systemic effects was >2000 mg/kg; both endpoints were based on absence of significant histopathological findings. For the 90-day inhalation study the NOAEL was 20.1 mg/m³ (28.2 mg/m³ adjusted) based on local effects in the upper respiratory tract. In  the chronic inhalation study, the NOAEL for systemic effects in the rat following inhalation was >103.9 mg/m3 (172.5 mg/m3 adjusted) based on the absence of any significant histopathological changes or alterations in haematology. The LOEC for local effects was 20.7 mg/m³ (34.4 mg/m³ adjusted), based on irritant effects on the nasal passages.  A conservative estimate of the NOAEC was set at half the LOAEC, that is 10.4 mg/m³ total hydrocarbon concentration (17.2 mg/m³ adjusted) based on the minimal effects and the fact that in the 90-day study a NOAEC of 20.1 mg/m³ (28.2 mg/m³ adjusted) was found. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/540fc9b2-4171-484c-8de9-188213097e53/documents/cfb925c3-4d76-4dc9-acaa-e3300d521425_4d4b5640-b6a2-4ccf-8676-573d98cfd432.html,,,,,, "Residues (petroleum), thermal cracked vacuum",92062-05-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/540fc9b2-4171-484c-8de9-188213097e53/documents/cfb925c3-4d76-4dc9-acaa-e3300d521425_4d4b5640-b6a2-4ccf-8676-573d98cfd432.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rabbit "Residues (petroleum), thermal cracked vacuum",92062-05-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/540fc9b2-4171-484c-8de9-188213097e53/documents/cfb925c3-4d76-4dc9-acaa-e3300d521425_4d4b5640-b6a2-4ccf-8676-573d98cfd432.html,Chronic toxicity – systemic effects,inhalation,NOAEC,172.5 mg/m3,,rat "Residues (petroleum), thermal cracked vacuum",92062-05-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/540fc9b2-4171-484c-8de9-188213097e53/documents/cfb925c3-4d76-4dc9-acaa-e3300d521425_4d4b5640-b6a2-4ccf-8676-573d98cfd432.html,Repeated dose toxicity – local effects,dermal,LOAEL,1.9 mg/cm2,adverse effect observed,rabbit "Residues (petroleum), thermal cracked vacuum",92062-05-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/540fc9b2-4171-484c-8de9-188213097e53/documents/cfb925c3-4d76-4dc9-acaa-e3300d521425_4d4b5640-b6a2-4ccf-8676-573d98cfd432.html,Repeated dose toxicity – local effects,inhalation,NOAEC,17.2 mg/m3,adverse effect observed,rat "Residues (petroleum), thermal cracked vacuum",92062-05-0,"Key acute oral (OECD 401), dermal (OECD 402), and inhalation (OECD 403) studies were identified.• The oral LD50 was > 5000 mg/kg bw in male and female rats for two petroleum vacuum residues.• The dermal LD50 was > 2000 mg/kg bw in male and female rabbits for two petroleum vacuum residues.• The LC50 was > 94.4 mg/m3 in male and female rats for fumes from oxidized (air-rectified) asphalt. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/540fc9b2-4171-484c-8de9-188213097e53/documents/e690a326-d489-4230-962e-68962f5ed2e6_4d4b5640-b6a2-4ccf-8676-573d98cfd432.html,,,,,, "Residues (petroleum), thermal cracked vacuum",92062-05-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/540fc9b2-4171-484c-8de9-188213097e53/documents/e690a326-d489-4230-962e-68962f5ed2e6_4d4b5640-b6a2-4ccf-8676-573d98cfd432.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), thermal cracked vacuum",92062-05-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/540fc9b2-4171-484c-8de9-188213097e53/documents/e690a326-d489-4230-962e-68962f5ed2e6_4d4b5640-b6a2-4ccf-8676-573d98cfd432.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), thermal cracked vacuum",92062-05-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/540fc9b2-4171-484c-8de9-188213097e53/documents/e690a326-d489-4230-962e-68962f5ed2e6_4d4b5640-b6a2-4ccf-8676-573d98cfd432.html,,inhalation,LC50,94.4 mg/m3,no adverse effect observed, "Residues (petroleum), vacuum",64741-56-6," The following studies were identified: two read-across 28-day dermal studies (OECD 410); a 90-day inhalation study; and a read across chronic inhalation study (OECD 451). In addition a supporting inhalation study is available ( 14 days). In a combined repeat dose / reproductive screening study with oxidized asphalt, no significant effects were observed For the dermal studies performed on rabbits, the LOAEL topical effects for both samples of vacuum residue was 200 mg/kg/day and the NOAEL for systemic effects was >2000 mg/kg; both endpoints were based on absence of significant histopathological findings. For the 90-day inhalation study the NOAEL was 20.1 mg/m³ (28.2 mg/m³ adjusted) based on local effects in the upper respiratory tract. In  the chronic inhalation study, the NOAEL for systemic effects in the rat following inhalation was >103.9 mg/m3 (172.5 mg/m3 adjusted) based on the absence of any significant histopathological changes or alterations in haematology. The LOEC for local effects was 20.7 mg/m³ (34.4 mg/m³ adjusted), based on irritant effects on the nasal passages.  A conservative estimate of the NOAEC was set at half the LOAEC, that is 10.4 mg/m³ total hydrocarbon concentration (17.2 mg/m³ adjusted) based on the minimal effects and the fact that in the 90-day study a NOAEC of 20.1 mg/m³ (28.2 mg/m³ adjusted) was found. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efea8904-1a78-4573-aaab-78302a923d1f/documents/cfb925c3-4d76-4dc9-acaa-e3300d521425_4e9441c5-db17-46a8-ae30-cb9eab3a34ee.html,,,,,, "Residues (petroleum), vacuum",64741-56-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efea8904-1a78-4573-aaab-78302a923d1f/documents/cfb925c3-4d76-4dc9-acaa-e3300d521425_4e9441c5-db17-46a8-ae30-cb9eab3a34ee.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,000 mg/kg bw/day",,rabbit "Residues (petroleum), vacuum",64741-56-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efea8904-1a78-4573-aaab-78302a923d1f/documents/cfb925c3-4d76-4dc9-acaa-e3300d521425_4e9441c5-db17-46a8-ae30-cb9eab3a34ee.html,Chronic toxicity – systemic effects,inhalation,NOAEC,172.5 mg/m3,,rat "Residues (petroleum), vacuum",64741-56-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efea8904-1a78-4573-aaab-78302a923d1f/documents/cfb925c3-4d76-4dc9-acaa-e3300d521425_4e9441c5-db17-46a8-ae30-cb9eab3a34ee.html,Repeated dose toxicity – local effects,dermal,LOAEL,1.9 mg/cm2,adverse effect observed,rabbit "Residues (petroleum), vacuum",64741-56-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efea8904-1a78-4573-aaab-78302a923d1f/documents/cfb925c3-4d76-4dc9-acaa-e3300d521425_4e9441c5-db17-46a8-ae30-cb9eab3a34ee.html,Repeated dose toxicity – local effects,inhalation,NOAEC,17.2 mg/m3,adverse effect observed,rat "Residues (petroleum), vacuum",64741-56-6,"Key acute oral (OECD 401), dermal (OECD 402), and inhalation (OECD 403) studies were identified.• The oral LD50 was > 5000 mg/kg bw in male and female rats for two petroleum vacuum residues.• The dermal LD50 was > 2000 mg/kg bw in male and female rabbits for two petroleum vacuum residues.• The LC50 was > 94.4 mg/m3 in male and female rats for fumes from oxidized (air-rectified) asphalt. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efea8904-1a78-4573-aaab-78302a923d1f/documents/e690a326-d489-4230-962e-68962f5ed2e6_4e9441c5-db17-46a8-ae30-cb9eab3a34ee.html,,,,,, "Residues (petroleum), vacuum",64741-56-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efea8904-1a78-4573-aaab-78302a923d1f/documents/e690a326-d489-4230-962e-68962f5ed2e6_4e9441c5-db17-46a8-ae30-cb9eab3a34ee.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), vacuum",64741-56-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efea8904-1a78-4573-aaab-78302a923d1f/documents/e690a326-d489-4230-962e-68962f5ed2e6_4e9441c5-db17-46a8-ae30-cb9eab3a34ee.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Residues (petroleum), vacuum",64741-56-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efea8904-1a78-4573-aaab-78302a923d1f/documents/e690a326-d489-4230-962e-68962f5ed2e6_4e9441c5-db17-46a8-ae30-cb9eab3a34ee.html,,inhalation,LC50,94.4 mg/m3,no adverse effect observed, "Residues, copper-iron-lead-nickel matte, sulfuric acid-insol.",102110-49-6,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/104f1156-a24e-47e7-8192-43da2ce0316b/documents/33b69673-3bc4-4c0a-9cbe-9eea8016335b_9f096d30-7b77-4fe8-92eb-36e71e8d4a87.html,,,,,, "Residues, copper-iron-lead-nickel matte, sulfuric acid-insol.",102110-49-6,The acute toxicity is driven by the characteristics of the individual UVCB constituents. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/104f1156-a24e-47e7-8192-43da2ce0316b/documents/94aedde4-9b6e-4c2d-a3db-d33d184e306c_9f096d30-7b77-4fe8-92eb-36e71e8d4a87.html,,,,,, "Residues, copper-iron-lead-nickel matte, sulfuric acid-insol.",102110-49-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/104f1156-a24e-47e7-8192-43da2ce0316b/documents/94aedde4-9b6e-4c2d-a3db-d33d184e306c_9f096d30-7b77-4fe8-92eb-36e71e8d4a87.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Residues, precious metal refining cementation",102110-50-9,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b21b331-65d0-40ca-88ff-a02cd02b6495/documents/7e8cae10-d064-4457-ab39-76f9ddbc1b06_d3968c60-b93f-47ad-97c4-6dec6e22defd.html,,,,,, "Residues, precious metal refining cementation",102110-50-9,The acute toxicity is driven by the characteristics of the individual UVCB constituents. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b21b331-65d0-40ca-88ff-a02cd02b6495/documents/d6a392e6-8a7e-4525-8e4e-a673c246f8d0_d3968c60-b93f-47ad-97c4-6dec6e22defd.html,,,,,, "Resin acids and Rosin acids, aluminum salts",61789-65-9," Several key guideline (OECD 408, 414, 421, & 422 ) studies that investigated the repeated dose toxicity potential of Rosin; Rosin, hydrogenated; Rosin, oligomers; and Rosin, reaction products with formaldehyde following oral dietary exposure in rats are available. The results are summarized below: OECD 408 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL was determined to be 5000 ppm (equivalent to a mean achieved dosage of 335.2 mg/kg bw/day for males and 401.2 mg/kg bw/day for females) based on reduced body weight gains in animals of either sex exposed to 7500 ppm. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The NOAEL for systemic toxicity of Rosin, reaction products with formaldehyde was considered to be 3000 ppm (equivalent to mean achieved dosages of approximately 213.1 mg/kg bw/day or 255.2 mg/kg bw/day for males and females, respectively), based on the effects on body weight, body weight gain and, to a lesser extent, food consumption, observed among females exposed to diets containing 7500 ppm of the test material for ninety days. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): Based on a lack of adverse treatment-related effects observed at the highest concentration tested, the systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 6000 ppm for either sex (equivalent to a mean achieved dosage of 334.5 mg/kg bw/day for males and 399.8 mg/kg bw/day for females). OECD 414 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 2500 ppm (equivalent to a mean achieved dosage of 199.3 mg/kg bw/day) based on lower maternal body weight gain during gestation and an initial effect on food consumption at 7500 ppm and lower maternal body weight gain at 5000 ppm. OECD 421 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 1000 ppm in males (equivalent to 84 mg/kg bw/d) and 3000 ppm in females (equivalent to 309 mg/kg bw/d) based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material. OECD 422 1) Rosin (CAS# 8050 -09 -7): In a key combined repeated dose, reproductive/developmental toxicity screening study (Harlan Laboratories Ltd, 2015a), the sytemic toxicity NOAEL for Tall oil rosin was determined to be 5000 ppm. In another key combined repeated dose, reproductive/developmental toxicity study (Harlan Laboratories Ltd., 2014a), the systemic toxicity NOAEL for Gum Rosin was determined to be 2500 ppm. A NOEL (No Observed Effect Level) for general toxicity could not be established due to effects on body weights at all dose levels in females during the lactation period. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The systemic toxicity NOAEL for Rosin, reaction product with formaldehyde was determined to be 10000 ppm and the NOEL was established at a concentration of 1000 ppm. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): The systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 3000 ppm. Based on the histopathological changes observed in adrenal glands, no NOEL for systemic toxicity was established for females whereas for males it was at the dose level of 1000 ppm. 4) Rosin, oligomers: The systemic toxicity NOAEL for Rosin, oligomers in male rats was determined to be 7500 ppm, based on statistically significant body weight and body weight gain effects observed at the 15000 ppm concentration level. The systemic toxicity NOAEL for female rats was determined to be 3000 ppm, based on effects on body weight and body weight gain in females exposed to the test material at 7500 and 15000 ppm. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/46e1d883-6510-4393-a949-e2728acb95d3/documents/2294ae88-2006-42dd-9bdd-497421fdacd1_6d86bf03-9228-40f6-a06a-bd781e04276e.html,,,,,, "Resin acids and Rosin acids, ammonium salts",68649-89-8," Acute oral toxicity LD50 was estimated to be 25335.71mg/kg bw , when male and female  Crl:CDBR rats were exposed with Resin acids and Rosin acids, ammonium salts (68649-89-8) orally. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d97f28ad-ec13-4a77-8a77-d1cdb3edb030/documents/f10ee075-ac11-4b59-92db-91972f786986_614c0013-ca5f-47c3-9e66-84fae2afa3a6.html,,,,,, "Resin acids and Rosin acids, ammonium salts",68649-89-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d97f28ad-ec13-4a77-8a77-d1cdb3edb030/documents/f10ee075-ac11-4b59-92db-91972f786986_614c0013-ca5f-47c3-9e66-84fae2afa3a6.html,,oral,LD50,"25,335.71 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, barium salts",68188-14-7," Since no experimental data regarding the acute toxicity of the test substance were available, a weight of evidence approach for the endpoint acute oral toxicity was conducted to determine hazard classification. It was concluded that the test substance is harmful by inhalation and if swallowed according to the harmonised classification and labelling for barium salts approved by the European Union (Regulation (EC) 1272/2008 Annex VI; Index-no: 056-002-00-7 / CLP 00). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1222cfc4-9a1b-4d94-857c-6e533eea3c63/documents/eb2e74cd-4bf8-42e4-b8b2-ee1df39e47af_17b8feb0-11c0-4aba-8f0b-e273438800c0.html,,,,,, "Resin acids and Rosin acids, calcium salts",9007-13-0," Several key guideline (OECD 408, 414, 421, & 422 ) studies that investigated the repeated dose toxicity potential of Rosin; Rosin, hydrogenated; Rosin, oligomers; and Rosin, reaction products with formaldehyde following oral dietary exposure in rats are available. The results are summarized below: OECD 408 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL was determined to be 5000 ppm (equivalent to a mean achieved dosage of 335.2 mg/kg bw/day for males and 401.2 mg/kg bw/day for females) based on reduced body weight gains in animals of either sex exposed to 7500 ppm. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The NOAEL for systemic toxicity of Rosin, reaction products with formaldehyde was considered to be 3000 ppm (equivalent to mean achieved dosages of approximately 213.1 mg/kg bw/day or 255.2 mg/kg bw/day for males and females, respectively), based on the effects on body weight, body weight gain and, to a lesser extent, food consumption, observed among females exposed to diets containing 7500 ppm of the test material for ninety days. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): Based on a lack of adverse treatment-related effects observed at the highest concentration tested, the systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 6000 ppm for either sex (equivalent to a mean achieved dosage of 334.5 mg/kg bw/day for males and 399.8 mg/kg bw/day for females). OECD 414 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 2500 ppm (equivalent to a mean achieved dosage of 199.3 mg/kg bw/day) based on lower maternal body weight gain during gestation and an initial effect on food consumption at 7500 ppm and lower maternal body weight gain at 5000 ppm. OECD 421 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 1000 ppm in males (equivalent to 84 mg/kg bw/d) and 3000 ppm in females (equivalent to 309 mg/kg bw/d) based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material. OECD 422 1) Rosin (CAS# 8050 -09 -7): In a key combined repeated dose, reproductive/developmental toxicity screening study (Harlan Laboratories Ltd, 2015a), the sytemic toxicity NOAEL for Tall oil rosin was determined to be 5000 ppm. In another key combined repeated dose, reproductive/developmental toxicity study (Harlan Laboratories Ltd., 2014a), the systemic toxicity NOAEL for Gum Rosin was determined to be 2500 ppm. A NOEL (No Observed Effect Level) for general toxicity could not be established due to effects on body weights at all dose levels in females during the lactation period. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The systemic toxicity NOAEL for Rosin, reaction product with formaldehyde was determined to be 10000 ppm and the NOEL was established at a concentration of 1000 ppm. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): The systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 3000 ppm. Based on the histopathological changes observed in adrenal glands, no NOEL for systemic toxicity was established for females whereas for males it was at the dose level of 1000 ppm. 4) Rosin, oligomers: The systemic toxicity NOAEL for Rosin, oligomers in male rats was determined to be 7500 ppm, based on statistically significant body weight and body weight gain effects observed at the 15000 ppm concentration level. The systemic toxicity NOAEL for female rats was determined to be 3000 ppm, based on effects on body weight and body weight gain in females exposed to the test material at 7500 and 15000 ppm. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37dfe6ca-ed21-4a32-80bd-fcf4f2072296/documents/0eba63bb-f8c1-4c95-a3d1-17ee231ad5fa_4f7d4c0e-c281-472b-b50a-d2bdd05b28f4.html,,,,,, "Resin acids and Rosin acids, calcium salts",9007-13-0,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37dfe6ca-ed21-4a32-80bd-fcf4f2072296/documents/e2fb65ec-ab8d-4874-877e-6161912003c0_4f7d4c0e-c281-472b-b50a-d2bdd05b28f4.html,,,,,, "Resin acids and Rosin acids, calcium salts",9007-13-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37dfe6ca-ed21-4a32-80bd-fcf4f2072296/documents/e2fb65ec-ab8d-4874-877e-6161912003c0_4f7d4c0e-c281-472b-b50a-d2bdd05b28f4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, calcium salts",9007-13-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37dfe6ca-ed21-4a32-80bd-fcf4f2072296/documents/e2fb65ec-ab8d-4874-877e-6161912003c0_4f7d4c0e-c281-472b-b50a-d2bdd05b28f4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, calcium zinc salts",68334-35-0," Several key guideline (OECD 408, 414, 421, & 422 ) studies that investigated the repeated dose toxicity potential of Rosin; Rosin, hydrogenated; Rosin, oligomers; and Rosin, reaction products with formaldehyde following oral dietary exposure in rats are available. The results are summarized below: OECD 408 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL was determined to be 5000 ppm (equivalent to a mean achieved dosage of 335.2 mg/kg bw/day for males and 401.2 mg/kg bw/day for females) based on reduced body weight gains in animals of either sex exposed to 7500 ppm. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The NOAEL for systemic toxicity of Rosin, reaction products with formaldehyde was considered to be 3000 ppm (equivalent to mean achieved dosages of approximately 213.1 mg/kg bw/day or 255.2 mg/kg bw/day for males and females, respectively), based on the effects on body weight, body weight gain and, to a lesser extent, food consumption, observed among females exposed to diets containing 7500 ppm of the test material for ninety days. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): Based on a lack of adverse treatment-related effects observed at the highest concentration tested, the systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 6000 ppm for either sex (equivalent to a mean achieved dosage of 334.5 mg/kg bw/day for males and 399.8 mg/kg bw/day for females). OECD 414 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 2500 ppm (equivalent to a mean achieved dosage of 199.3 mg/kg bw/day) based on lower maternal body weight gain during gestation and an initial effect on food consumption at 7500 ppm and lower maternal body weight gain at 5000 ppm. OECD 421 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 1000 ppm in males (equivalent to 84 mg/kg bw/d) and 3000 ppm in females (equivalent to 309 mg/kg bw/d) based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material. OECD 422 1) Rosin (CAS# 8050 -09 -7): In a key combined repeated dose, reproductive/developmental toxicity screening study (Harlan Laboratories Ltd, 2015a), the sytemic toxicity NOAEL for Tall oil rosin was determined to be 5000 ppm. In another key combined repeated dose, reproductive/developmental toxicity study (Harlan Laboratories Ltd., 2014a), the systemic toxicity NOAEL for Gum Rosin was determined to be 2500 ppm. A NOEL (No Observed Effect Level) for general toxicity could not be established due to effects on body weights at all dose levels in females during the lactation period. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The systemic toxicity NOAEL for Rosin, reaction product with formaldehyde was determined to be 10000 ppm and the NOEL was established at a concentration of 1000 ppm. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): The systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 3000 ppm. Based on the histopathological changes observed in adrenal glands, no NOEL for systemic toxicity was established for females whereas for males it was at the dose level of 1000 ppm. 4) Rosin, oligomers: The systemic toxicity NOAEL for Rosin, oligomers in male rats was determined to be 7500 ppm, based on statistically significant body weight and body weight gain effects observed at the 15000 ppm concentration level. The systemic toxicity NOAEL for female rats was determined to be 3000 ppm, based on effects on body weight and body weight gain in females exposed to the test material at 7500 and 15000 ppm. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e48ca16-436f-4f58-bfcb-117b3d9c0b23/documents/a9212f99-ea8c-4b65-8dd6-53fc9c3689d8_2c6c5b5d-d7c9-43d4-9de6-8dbc4036dcdb.html,,,,,, "Resin acids and Rosin acids, calcium zinc salts",68334-35-0,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e48ca16-436f-4f58-bfcb-117b3d9c0b23/documents/29f2125c-88ad-4ceb-bb31-ed0ea20b9a50_2c6c5b5d-d7c9-43d4-9de6-8dbc4036dcdb.html,,,,,, "Resin acids and Rosin acids, calcium zinc salts",68334-35-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e48ca16-436f-4f58-bfcb-117b3d9c0b23/documents/29f2125c-88ad-4ceb-bb31-ed0ea20b9a50_2c6c5b5d-d7c9-43d4-9de6-8dbc4036dcdb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, calcium zinc salts",68334-35-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e48ca16-436f-4f58-bfcb-117b3d9c0b23/documents/29f2125c-88ad-4ceb-bb31-ed0ea20b9a50_2c6c5b5d-d7c9-43d4-9de6-8dbc4036dcdb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, cobalt salts",68956-82-1,"Acute oral toxicity:LD50(female rats)>2000mg/kg bwAcute toxicity, dermal:LD50(male/female rats)>2000mg/kg bwAcute toxicity, inhalation:LC50 (male and female rats, 4 hours) > 5 mg/L air ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd179c53-3600-4d1b-84d6-632c4d202ad1/documents/IUC5-d19c5b7b-c457-430e-b695-d14c0dbbcae0_ea75a296-549d-43a4-a660-26217a8348ed.html,,,,,, "Resin acids and Rosin acids, esters with ethylene glycol",68512-65-2," Information is available on the oral repeated dose toxicity of Rosin esters (simple, linear, and bulky). No treatment-related or biologically relevant findings were apparent in rats following oral sub-chronic dietary exposure to Resin acids and rosin acids, esters with glycerol, Resin acids and rosin acids, esters with ethylene glycol, Resin acids and rosin acids, esters with triethylene glycol, Resin acids and rosin acids, hydrogenated, esters with glycerol and Resin acids and rosin acids, hydrogenated, esters with pentaerythritol. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/df987e40-1b7b-44f6-9a17-ae27a88d217c/documents/de4de74c-bdda-4e47-ac79-9a62bba41a5c_17268fc8-aa3c-49fb-8943-953697e80473.html,,,,,, "Resin acids and Rosin acids, esters with ethylene glycol",68512-65-2,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df987e40-1b7b-44f6-9a17-ae27a88d217c/documents/84c2d846-1e95-418c-9c9a-4b5e08f7b142_17268fc8-aa3c-49fb-8943-953697e80473.html,,,,,, "Resin acids and Rosin acids, esters with ethylene glycol",68512-65-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df987e40-1b7b-44f6-9a17-ae27a88d217c/documents/84c2d846-1e95-418c-9c9a-4b5e08f7b142_17268fc8-aa3c-49fb-8943-953697e80473.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, esters with ethylene glycol",68512-65-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df987e40-1b7b-44f6-9a17-ae27a88d217c/documents/84c2d846-1e95-418c-9c9a-4b5e08f7b142_17268fc8-aa3c-49fb-8943-953697e80473.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, esters with triethylene glycol",8050-25-7," Information is available on the oral repeated dose toxicity of Rosin esters (simple, linear, and bulky). No treatment-related or biologically relevant findings were apparent in rats following oral sub-chronic dietary exposure to Resin acids and rosin acids, esters with glycerol, Resin acids and rosin acids, esters with ethylene glycol, Resin acids and rosin acids, esters with triethylene glycol, Resin acids and rosin acids, hydrogenated, esters with glycerol and Resin acids and rosin acids, hydrogenated, esters with pentaerythritol. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fab2311b-61e3-450f-b036-30cd2ad866ff/documents/e13d1615-5699-4fb2-8078-5ce81c7bdade_937ecf14-33fe-4dbb-9fa1-5cc74f82bd79.html,,,,,, "Resin acids and Rosin acids, esters with triethylene glycol",8050-25-7,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fab2311b-61e3-450f-b036-30cd2ad866ff/documents/2e028c2f-8f5c-429a-a298-e477e82501fb_937ecf14-33fe-4dbb-9fa1-5cc74f82bd79.html,,,,,, "Resin acids and Rosin acids, esters with triethylene glycol",8050-25-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fab2311b-61e3-450f-b036-30cd2ad866ff/documents/2e028c2f-8f5c-429a-a298-e477e82501fb_937ecf14-33fe-4dbb-9fa1-5cc74f82bd79.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, esters with triethylene glycol",8050-25-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fab2311b-61e3-450f-b036-30cd2ad866ff/documents/2e028c2f-8f5c-429a-a298-e477e82501fb_937ecf14-33fe-4dbb-9fa1-5cc74f82bd79.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, esters with trimethylolpropane",84776-83-0," Information is available on the oral repeated dose toxicity of Rosin esters (simple, linear, and bulky). No treatment-related or biologically relevant findings were apparent in rats following oral sub-chronic dietary exposure to Resin acids and rosin acids, esters with glycerol, Resin acids and rosin acids, esters with ethylene glycol, Resin acids and rosin acids, esters with triethylene glycol, Resin acids and rosin acids, hydrogenated, esters with glycerol and Resin acids and rosin acids, hydrogenated, esters with pentaerythritol. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e322f689-51a5-470a-a78a-fefb26bbfa0d/documents/5819454f-3b0d-48ab-b2d6-2f8fe7eaf7fa_728c7238-4877-41fa-8d59-c2f4d9a5c5e2.html,,,,,, "Resin acids and Rosin acids, esters with trimethylolpropane",84776-83-0,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e322f689-51a5-470a-a78a-fefb26bbfa0d/documents/43b2baec-706a-4e5e-b618-e25daaa0d7a3_728c7238-4877-41fa-8d59-c2f4d9a5c5e2.html,,,,,, "Resin acids and Rosin acids, esters with trimethylolpropane",84776-83-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e322f689-51a5-470a-a78a-fefb26bbfa0d/documents/43b2baec-706a-4e5e-b618-e25daaa0d7a3_728c7238-4877-41fa-8d59-c2f4d9a5c5e2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, esters with trimethylolpropane",84776-83-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e322f689-51a5-470a-a78a-fefb26bbfa0d/documents/43b2baec-706a-4e5e-b618-e25daaa0d7a3_728c7238-4877-41fa-8d59-c2f4d9a5c5e2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, fumarated, compds. with triethanolamine",91081-22-0,"Oral (OECD 422) rosin fumarated, rat: NOAEL = 221-228 mg/kg bw/d (males) and 196-292 mg/kg bw/d (females) ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c59570a6-bb4a-44c7-84c4-f180458b008e/documents/IUC5-30686a46-e79d-468b-bc16-f944b3c15c42_f13f69e8-18af-4107-8a1d-3f059a679814.html,,,,,, "Resin acids and Rosin acids, fumarated, compds. with triethanolamine",91081-22-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c59570a6-bb4a-44c7-84c4-f180458b008e/documents/IUC5-30686a46-e79d-468b-bc16-f944b3c15c42_f13f69e8-18af-4107-8a1d-3f059a679814.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,196 mg/kg bw/day,,rat "Resin acids and Rosin acids, fumarated, compds. with triethanolamine",91081-22-0,"Acute toxicity: Oral (OECD 401), rat: LD50 > 2000 mg/kg bwDermal (OECD 402), rat: LD50 >2000 mg/kg bw ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c59570a6-bb4a-44c7-84c4-f180458b008e/documents/IUC5-9a4d632f-f428-45a0-a4ef-17070a778aa1_f13f69e8-18af-4107-8a1d-3f059a679814.html,,,,,, "Resin acids and Rosin acids, fumarated, compds. with triethanolamine",91081-22-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c59570a6-bb4a-44c7-84c4-f180458b008e/documents/IUC5-9a4d632f-f428-45a0-a4ef-17070a778aa1_f13f69e8-18af-4107-8a1d-3f059a679814.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, fumarated, compds. with triethanolamine",91081-22-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c59570a6-bb4a-44c7-84c4-f180458b008e/documents/IUC5-9a4d632f-f428-45a0-a4ef-17070a778aa1_f13f69e8-18af-4107-8a1d-3f059a679814.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, fumarated, esters with glycerol",97489-11-7," Several key Guideline (OECD 408, 414, 421, & 422) studies that investigated the repeated dose toxicity potential of Rosin Adduct Esters following oral dietary exposure in rats are available. The results are summarized below:   OECD 408 1) Rosin acids and resin acids, maleated, esters with pentaerythritol (CAS# 94581-17-6): The systemic toxicity NOAEL was determined to be 3000 ppm (equivalent to mean achieved dosages of 209.1 mg/Kg bw/day for males and 248.7 mg/Kg bw/day for females), based on histopathological changes apparent in both the liver and urinary bladder in animals exposed at the 6000 ppm and 12000/15000 ppm concentration levels.   2) Resin acids and Rosin acids, fumarated, esters with pentaerythitol (CAS# 94581-15-4): The NOAEL for systemic toxicity was considered to be 18000 ppm (equivalent to a mean achieved dosage of 1090.0 mg/Kg bw/day for males and 1298.9 mg/Kg bw/day for females), based on based on the lack of adverse treatment-related effects observed through the study period.   3) RARA, fumarated, esters with glycerol (CAS# 97489-11-7): The NOAEL for systemic toxicity was determined to be 18000 ppm for female rats (equivalent to mean achieved dosages of 1482.2 mg/Kg bw/day) and 7500 ppm (equivalent to mean achieved dosages of 574.0 mg/Kg bw/day) for male rats, based on treatment-related effects observed in male rats exposed at 18000 ppm. OECD 422   1) Resin acids and rosin acids, maleated, esters with pentaerythritol (CAS# 94581-17-6): The No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be 3000 ppm (equivalent to a mean achieved dosage of 179.3 mg/Kg bw/day in males and 221.5 mg/Kg bw/day in females), based on effects on body weight gain, food consumption and adverse histopathological changes in the kidney and urinary bladder at 7500 ppm and 18000/12000 ppm.   2) Resin acids and rosin acids, fumarated, esters with glycerol (CAS# 97489-11-7): The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was determined to be 7500 ppm for either sex (equivalent to a mean achieved dosage of 432.2 mg/Kg bw/day in males and 544.4 mg/Kg bw/day in females), based on microscopic lung changes in animals of either sex treated with 18000/15000 ppm, microscopic urinary bladder changes in females treated with 18000/15000 ppm and microscopic prostate changes in males treated with 18000 or 7500 ppm.   3) Resin acids and rosin acids, fumarated, esters with pentaerythritol (CAS# 94581-15-4): The No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was established to be 300 mg/Kg/day, based on evidence of limited systemic effects (microscopic changes in the urinary bladder) observed in animals in the 1000 mg/Kg bw/day dose group.   4) Rosin, fumarated (CAS# 65997-04-8): The No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was established to be 3000 ppm (equivalent to 221-288 mg/Kg bw/d in males, and 196-292 mg/Kg bw/d in females), based on decreased food consumption and mean body weights in parental animals of both sexes at 10,000 ppm and 3000 ppm, with high dose animals also showing an increase in total bilirubin (both sexes) and decreased adrenal weight (females only).   OECD 421   1) Resin acids and rosin acids, esters with pentaerythritol (CAS# 8050-26-8): The NOAEL was determined to be 20000 ppm (equivalent to received doses of 1864 mg/Kg bw/d in males and 1757 -2054 mg/Kg bw/d in females, respectively), based on lack of adverse treatment-related effects observed on reproductive performance or other parameters evaluated in the study.   2) Rosin (CAS# 8050-09-7): The NOAEL for systemic toxicity was considered to be 1000 ppm in males (equivalent to 84 mg/Kg bw/day) and 3000 ppm in females (equivalent to 309 mg/Kg bw/day), based on reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material.    OECD 414   1) Resin acids and rosin acids, fumarated esters with glycerol (CAS# 97489-11-7): The systemic toxicity NOAEL was determined to be 7500 ppm (equivalent to a mean achieved dosage of 622.2 mg/kg bw/day), based on lower maternal body weight gain during gestation and an initial effect on food consumption observed in animals treated at the 15000 ppm concentration level. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e3086527-9b6f-400a-8994-903de45bfeb2/documents/6267d153-e363-439d-8da7-19b4f18343db_98d33d31-fe25-4d9c-9082-280a56f83ab3.html,,,,,, "Resin acids and Rosin acids, fumarated, esters with glycerol",97489-11-7,Not acutely toxic following oral exposure or skin contact (LD50 >2000 mg/kg bw). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3086527-9b6f-400a-8994-903de45bfeb2/documents/22eff58e-082b-42d8-bee2-2dd5a04c5eea_98d33d31-fe25-4d9c-9082-280a56f83ab3.html,,,,,, "Resin acids and Rosin acids, fumarated, esters with glycerol",97489-11-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3086527-9b6f-400a-8994-903de45bfeb2/documents/22eff58e-082b-42d8-bee2-2dd5a04c5eea_98d33d31-fe25-4d9c-9082-280a56f83ab3.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, fumarated, esters with glycerol",97489-11-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3086527-9b6f-400a-8994-903de45bfeb2/documents/22eff58e-082b-42d8-bee2-2dd5a04c5eea_98d33d31-fe25-4d9c-9082-280a56f83ab3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, fumarated, esters with pentaerythritol",94581-15-4," Several key Guideline (OECD 408, 414, 421, & 422) studies that investigated the repeated dose toxicity potential of Rosin Adduct Esters following oral dietary exposure in rats are available. The results are summarized below:   OECD 408 1) Rosin acids and resin acids, maleated, esters with pentaerythritol (CAS# 94581-17-6): The systemic toxicity NOAEL was determined to be 3000 ppm (equivalent to mean achieved dosages of 209.1 mg/Kg bw/day for males and 248.7 mg/Kg bw/day for females), based on histopathological changes apparent in both the liver and urinary bladder in animals exposed at the 6000 ppm and 12000/15000 ppm concentration levels.   2) Resin acids and Rosin acids, fumarated, esters with pentaerythitol (CAS# 94581-15-4): The NOAEL for systemic toxicity was considered to be 18000 ppm (equivalent to a mean achieved dosage of 1090.0 mg/Kg bw/day for males and 1298.9 mg/Kg bw/day for females), based on based on the lack of adverse treatment-related effects observed through the study period.   3) RARA, fumarated, esters with glycerol (CAS# 97489-11-7): The NOAEL for systemic toxicity was determined to be 18000 ppm for female rats (equivalent to mean achieved dosages of 1482.2 mg/Kg bw/day) and 7500 ppm (equivalent to mean achieved dosages of 574.0 mg/Kg bw/day) for male rats, based on treatment-related effects observed in male rats exposed at 18000 ppm. OECD 422   1) Resin acids and rosin acids, maleated, esters with pentaerythritol (CAS# 94581-17-6): The No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be 3000 ppm (equivalent to a mean achieved dosage of 179.3 mg/Kg bw/day in males and 221.5 mg/Kg bw/day in females), based on effects on body weight gain, food consumption and adverse histopathological changes in the kidney and urinary bladder at 7500 ppm and 18000/12000 ppm.   2) Resin acids and rosin acids, fumarated, esters with glycerol (CAS# 97489-11-7): The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was determined to be 7500 ppm for either sex (equivalent to a mean achieved dosage of 432.2 mg/Kg bw/day in males and 544.4 mg/Kg bw/day in females), based on microscopic lung changes in animals of either sex treated with 18000/15000 ppm, microscopic urinary bladder changes in females treated with 18000/15000 ppm and microscopic prostate changes in males treated with 18000 or 7500 ppm.   3) Resin acids and rosin acids, fumarated, esters with pentaerythritol (CAS# 94581-15-4): The No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was established to be 300 mg/Kg/day, based on evidence of limited systemic effects (microscopic changes in the urinary bladder) observed in animals in the 1000 mg/Kg bw/day dose group.   4) Rosin, fumarated (CAS# 65997-04-8): The No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was established to be 3000 ppm (equivalent to 221-288 mg/Kg bw/d in males, and 196-292 mg/Kg bw/d in females), based on decreased food consumption and mean body weights in parental animals of both sexes at 10,000 ppm and 3000 ppm, with high dose animals also showing an increase in total bilirubin (both sexes) and decreased adrenal weight (females only).   OECD 421   1) Resin acids and rosin acids, esters with pentaerythritol (CAS# 8050-26-8): The NOAEL was determined to be 20000 ppm (equivalent to received doses of 1864 mg/Kg bw/d in males and 1757 -2054 mg/Kg bw/d in females, respectively), based on lack of adverse treatment-related effects observed on reproductive performance or other parameters evaluated in the study.   2) Rosin (CAS# 8050-09-7): The NOAEL for systemic toxicity was considered to be 1000 ppm in males (equivalent to 84 mg/Kg bw/day) and 3000 ppm in females (equivalent to 309 mg/Kg bw/day), based on reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material.    OECD 414   1) Resin acids and rosin acids, fumarated esters with glycerol (CAS# 97489-11-7): The systemic toxicity NOAEL was determined to be 7500 ppm (equivalent to a mean achieved dosage of 622.2 mg/kg bw/day), based on lower maternal body weight gain during gestation and an initial effect on food consumption observed in animals treated at the 15000 ppm concentration level. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/90fe7a9b-6aeb-46c5-88f9-a0d30efe954b/documents/84535e7d-baed-45b5-977f-b44f254829d4_b93042b8-7579-42b3-9f25-cd376fda65ce.html,,,,,, "Resin acids and Rosin acids, fumarated, esters with pentaerythritol",94581-15-4,Not acutely toxic following oral exposure or skin contact (LD50 >2000 mg/kg bw). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90fe7a9b-6aeb-46c5-88f9-a0d30efe954b/documents/89f76b8f-9733-4da1-adc5-753726b7dff1_b93042b8-7579-42b3-9f25-cd376fda65ce.html,,,,,, "Resin acids and Rosin acids, fumarated, esters with pentaerythritol",94581-15-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90fe7a9b-6aeb-46c5-88f9-a0d30efe954b/documents/89f76b8f-9733-4da1-adc5-753726b7dff1_b93042b8-7579-42b3-9f25-cd376fda65ce.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, fumarated, esters with pentaerythritol",94581-15-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90fe7a9b-6aeb-46c5-88f9-a0d30efe954b/documents/89f76b8f-9733-4da1-adc5-753726b7dff1_b93042b8-7579-42b3-9f25-cd376fda65ce.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, hydrogenated, calcium salts",68554-12-1," Several key guideline (OECD 408, 414, 421, & 422 ) studies that investigated the repeated dose toxicity potential of Rosin; Rosin, hydrogenated; Rosin, oligomers; and Rosin, reaction products with formaldehyde following oral dietary exposure in rats are available. The results are summarized below: OECD 408 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL was determined to be 5000 ppm (equivalent to a mean achieved dosage of 335.2 mg/kg bw/day for males and 401.2 mg/kg bw/day for females) based on reduced body weight gains in animals of either sex exposed to 7500 ppm. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The NOAEL for systemic toxicity of Rosin, reaction products with formaldehyde was considered to be 3000 ppm (equivalent to mean achieved dosages of approximately 213.1 mg/kg bw/day or 255.2 mg/kg bw/day for males and females, respectively), based on the effects on body weight, body weight gain and, to a lesser extent, food consumption, observed among females exposed to diets containing 7500 ppm of the test material for ninety days. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): Based on a lack of adverse treatment-related effects observed at the highest concentration tested, the systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 6000 ppm for either sex (equivalent to a mean achieved dosage of 334.5 mg/kg bw/day for males and 399.8 mg/kg bw/day for females). OECD 414 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 2500 ppm (equivalent to a mean achieved dosage of 199.3 mg/kg bw/day) based on lower maternal body weight gain during gestation and an initial effect on food consumption at 7500 ppm and lower maternal body weight gain at 5000 ppm. OECD 421 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 1000 ppm in males (equivalent to 84 mg/kg bw/d) and 3000 ppm in females (equivalent to 309 mg/kg bw/d) based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material. OECD 422 1) Rosin (CAS# 8050 -09 -7): In a key combined repeated dose, reproductive/developmental toxicity screening study (Harlan Laboratories Ltd, 2015a), the sytemic toxicity NOAEL for Tall oil rosin was determined to be 5000 ppm. In another key combined repeated dose, reproductive/developmental toxicity study (Harlan Laboratories Ltd., 2014a), the systemic toxicity NOAEL for Gum Rosin was determined to be 2500 ppm. A NOEL (No Observed Effect Level) for general toxicity could not be established due to effects on body weights at all dose levels in females during the lactation period. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The systemic toxicity NOAEL for Rosin, reaction product with formaldehyde was determined to be 10000 ppm and the NOEL was established at a concentration of 1000 ppm. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): The systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 3000 ppm. Based on the histopathological changes observed in adrenal glands, no NOEL for systemic toxicity was established for females whereas for males it was at the dose level of 1000 ppm. 4) Rosin, oligomers: The systemic toxicity NOAEL for Rosin, oligomers was determined to be 7500 ppm due to a test item-related moribundity, necessitating euthanasia, at the high concentration. A NOEL for systemic toxicity could not be established due to effects on body weight gain and liver weights at all dose levels in males. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fed549e3-f12b-4a5f-a3d1-fe6bb77d91db/documents/e84b07b4-afa6-4bc0-b5d2-4506a8683b9d_6f4e0dd8-eeb2-4441-b195-8cff545dbe01.html,,,,,, "Resin acids and Rosin acids, hydrogenated, calcium salts",68554-12-1,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fed549e3-f12b-4a5f-a3d1-fe6bb77d91db/documents/09fd2f4e-0cf9-40bc-9276-dfabaf6a19c2_6f4e0dd8-eeb2-4441-b195-8cff545dbe01.html,,,,,, "Resin acids and Rosin acids, hydrogenated, calcium salts",68554-12-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fed549e3-f12b-4a5f-a3d1-fe6bb77d91db/documents/09fd2f4e-0cf9-40bc-9276-dfabaf6a19c2_6f4e0dd8-eeb2-4441-b195-8cff545dbe01.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, hydrogenated, calcium salts",68554-12-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fed549e3-f12b-4a5f-a3d1-fe6bb77d91db/documents/09fd2f4e-0cf9-40bc-9276-dfabaf6a19c2_6f4e0dd8-eeb2-4441-b195-8cff545dbe01.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, hydrogenated, sodium salts",68990-02-3," Several key guideline (OECD 408, 414, 421, & 422 ) studies that investigated the repeated dose toxicity potential of Rosin; Rosin, hydrogenated; Rosin, oligomers; and Rosin, reaction products with formaldehyde following oral dietary exposure in rats are available. The results are summarized below: OECD 408 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL was determined to be 5000 ppm (equivalent to a mean achieved dosage of 335.2 mg/kg bw/day for males and 401.2 mg/kg bw/day for females) based on reduced body weight gains in animals of either sex exposed to 7500 ppm. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The NOAEL for systemic toxicity of Rosin, reaction products with formaldehyde was considered to be 3000 ppm (equivalent to mean achieved dosages of approximately 213.1 mg/kg bw/day or 255.2 mg/kg bw/day for males and females, respectively), based on the effects on body weight, body weight gain and, to a lesser extent, food consumption, observed among females exposed to diets containing 7500 ppm of the test material for ninety days. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): Based on a lack of adverse treatment-related effects observed at the highest concentration tested, the systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 6000 ppm for either sex (equivalent to a mean achieved dosage of 334.5 mg/kg bw/day for males and 399.8 mg/kg bw/day for females). OECD 414 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 2500 ppm (equivalent to a mean achieved dosage of 199.3 mg/kg bw/day) based on lower maternal body weight gain during gestation and an initial effect on food consumption at 7500 ppm and lower maternal body weight gain at 5000 ppm. OECD 421 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 1000 ppm in males (equivalent to 84 mg/kg bw/d) and 3000 ppm in females (equivalent to 309 mg/kg bw/d) based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material. OECD 422 1) Rosin (CAS# 8050 -09 -7): In a key combined repeated dose, reproductive/developmental toxicity screening study (Harlan Laboratories Ltd, 2015a), the sytemic toxicity NOAEL for Tall oil rosin was determined to be 5000 ppm. In another key combined repeated dose, reproductive/developmental toxicity study (Harlan Laboratories Ltd., 2014a), the systemic toxicity NOAEL for Gum Rosin was determined to be 2500 ppm. A NOEL (No Observed Effect Level) for general toxicity could not be established due to effects on body weights at all dose levels in females during the lactation period. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The systemic toxicity NOAEL for Rosin, reaction product with formaldehyde was determined to be 10000 ppm and the NOEL was established at a concentration of 1000 ppm. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): The systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 3000 ppm. Based on the histopathological changes observed in adrenal glands, no NOEL for systemic toxicity was established for females whereas for males it was at the dose level of 1000 ppm. 4) Rosin, oligomers: The systemic toxicity NOAEL for Rosin, oligomers in male rats was determined to be 7500 ppm, based on statistically significant body weight and body weight gain effects observed at the 15000 ppm concentration level. The systemic toxicity NOAEL for female rats was determined to be 3000 ppm, based on effects on body weight and body weight gain in females exposed to the test material at 7500 and 15000 ppm. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/11425689-a439-4901-afea-9c9bb1746996/documents/b647bc65-6206-4d5a-90a7-96760044b0ce_7666def2-47be-4fe3-adff-ae57658b250d.html,,,,,, "Resin acids and Rosin acids, hydrogenated, sodium salts",68990-02-3,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11425689-a439-4901-afea-9c9bb1746996/documents/5d2788ab-265a-4082-adc2-d85651ddb8dc_7666def2-47be-4fe3-adff-ae57658b250d.html,,,,,, "Resin acids and Rosin acids, hydrogenated, sodium salts",68990-02-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11425689-a439-4901-afea-9c9bb1746996/documents/5d2788ab-265a-4082-adc2-d85651ddb8dc_7666def2-47be-4fe3-adff-ae57658b250d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, hydrogenated, sodium salts",68990-02-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11425689-a439-4901-afea-9c9bb1746996/documents/5d2788ab-265a-4082-adc2-d85651ddb8dc_7666def2-47be-4fe3-adff-ae57658b250d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, magnesium salts",68440-56-2," Several key guideline (OECD 408, 414, 421, & 422 ) studies that investigated the repeated dose toxicity potential of Rosin; Rosin, hydrogenated; Rosin, oligomers; and Rosin, reaction products with formaldehyde following oral dietary exposure in rats are available. The results are summarized below: OECD 408 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL was determined to be 5000 ppm (equivalent to a mean achieved dosage of 335.2 mg/kg bw/day for males and 401.2 mg/kg bw/day for females) based on reduced body weight gains in animals of either sex exposed to 7500 ppm. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The NOAEL for systemic toxicity of Rosin, reaction products with formaldehyde was considered to be 3000 ppm (equivalent to mean achieved dosages of approximately 213.1 mg/kg bw/day or 255.2 mg/kg bw/day for males and females, respectively), based on the effects on body weight, body weight gain and, to a lesser extent, food consumption, observed among females exposed to diets containing 7500 ppm of the test material for ninety days. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): Based on a lack of adverse treatment-related effects observed at the highest concentration tested, the systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 6000 ppm for either sex (equivalent to a mean achieved dosage of 334.5 mg/kg bw/day for males and 399.8 mg/kg bw/day for females). OECD 414 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 2500 ppm (equivalent to a mean achieved dosage of 199.3 mg/kg bw/day) based on lower maternal body weight gain during gestation and an initial effect on food consumption at 7500 ppm and lower maternal body weight gain at 5000 ppm. OECD 421 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 1000 ppm in males (equivalent to 84 mg/kg bw/d) and 3000 ppm in females (equivalent to 309 mg/kg bw/d) based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material. OECD 422 1) Rosin (CAS# 8050 -09 -7): In a key combined repeated dose, reproductive/developmental toxicity screening study (Harlan Laboratories Ltd, 2015a), the sytemic toxicity NOAEL for Tall oil rosin was determined to be 5000 ppm. In another key combined repeated dose, reproductive/developmental toxicity study (Harlan Laboratories Ltd., 2014a), the systemic toxicity NOAEL for Gum Rosin was determined to be 2500 ppm. A NOEL (No Observed Effect Level) for general toxicity could not be established due to effects on body weights at all dose levels in females during the lactation period. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The systemic toxicity NOAEL for Rosin, reaction product with formaldehyde was determined to be 10000 ppm and the NOEL was established at a concentration of 1000 ppm. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): The systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 3000 ppm. Based on the histopathological changes observed in adrenal glands, no NOEL for systemic toxicity was established for females whereas for males it was at the dose level of 1000 ppm. 4) Rosin, oligomers: The systemic toxicity NOAEL for Rosin, oligomers in male rats was determined to be 7500 ppm, based on statistically significant body weight and body weight gain effects observed at the 15000 ppm concentration level. The systemic toxicity NOAEL for female rats was determined to be 3000 ppm, based on effects on body weight and body weight gain in females exposed to the test material at 7500 and 15000 ppm. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/31d2e516-50d6-4a07-9232-f0703c8d1c4d/documents/bea5c5ea-ef51-4eb8-a2c6-a96d2ed7e9fd_0eaf141b-f0e2-4724-9375-1a25702dad32.html,,,,,, "Resin acids and Rosin acids, magnesium salts",68440-56-2,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31d2e516-50d6-4a07-9232-f0703c8d1c4d/documents/bd01f485-f566-4afc-8818-c2fb99f599b5_0eaf141b-f0e2-4724-9375-1a25702dad32.html,,,,,, "Resin acids and Rosin acids, magnesium salts",68440-56-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31d2e516-50d6-4a07-9232-f0703c8d1c4d/documents/bd01f485-f566-4afc-8818-c2fb99f599b5_0eaf141b-f0e2-4724-9375-1a25702dad32.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, magnesium salts",68440-56-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31d2e516-50d6-4a07-9232-f0703c8d1c4d/documents/bd01f485-f566-4afc-8818-c2fb99f599b5_0eaf141b-f0e2-4724-9375-1a25702dad32.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, maleated, calcium salts",91722-01-9," Several key Guideline (OECD 408, 414, & 422) studies that investigated the repeated dose toxicity potential of Rosin Adducts and Rosin Adducts Salts following oral dietary exposure in rats are available. The results are summarized below:   OECD 408   1) Rosin, Maleated (CAS# 8050-28-0): The No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be 1500 ppm (equivalent to a mean achieved dosage of 99.5 and 120.4 mg/Kg bw/day for males and females respectively due to reduced bodyweight gains and food consumption and adverse histopathological changes in the urinary bladder of both sexes exposed to a dietary concentration of 3000 ppm of the test material.   2) Rosin, Fumarated (CAS# 65997-04-8): The No Observed Adverse Effect Level (NOAEL) for systemic toxicity for both sexes was determined to be 10000 ppm (equivalent to a mean achieved dosage of 704.6 mg/kg bw/day for males and 843.4 mg/kg bw/day for females), based on a lack of adverse treatment-related effects observed at the highest concentration tested.   OECD 422   1) Rosin, Maleated (CAS# 8050-28-0): The No Observed Adverse Effect Level (NOAEL) for systemic toxicity for both sexes was considered to be 3500 ppm, based on effects on food consumption, food efficiency, body weight, and body weight gain observed at 7000 ppm.   2) Rosin, Fumarated (CAS# 65997-04-8): The No Observed Effect Level (NOEL) for systemic toxicity for both sexes was determined to be 1000 ppm (males 72 -97 mg/Kg bw/d; females 79 -108 mg/Kg bw/d), based on toxicity observed at levels of 3000 and 10000 ppm, with a decrease in mean body weight at both doses and sexes, an increase in total bilirubin in both sexes at 10000 ppm and a decrease in adrenal gland weight in females at 10000 ppm.   OECD 414    1) Rosin, Maleated (CAS# 8050-28-0): The No Observed Effect Level (NOEL) for the pregnant dam was determined to be 500 ppm (equivalent to an achieved dosage of approximately 41.2 mg/Kg bw/day of the test material). The No Observed Adverse Effect Level (NOAEL) for the pregnant dam was considered to be a dietary exposure to 1500 ppm (equivalent to an achieved dosage of approximately 122.9 mg/Kg bw/day of the test material), based on effects observed on body weight gain and food consumption at a dietary concentration of 3000 ppm. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e34a485-6b5b-43a3-8806-a0d9936447ee/documents/6c854ba5-db7b-4bb9-b9b6-a647ca879370_9265f001-c514-4c73-a440-17561ed9e68c.html,,,,,, "Resin acids and Rosin acids, maleated, calcium salts",91722-01-9,Not acutely toxic following oral exposure or skin contact (LD50 >2000 mg/kg bw). A low vapour pressure indicates that inhalation exposure is unlikely. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e34a485-6b5b-43a3-8806-a0d9936447ee/documents/a47ac0f3-b234-48ee-9215-046fbefa5827_9265f001-c514-4c73-a440-17561ed9e68c.html,,,,,, "Resin acids and Rosin acids, maleated, calcium salts",91722-01-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e34a485-6b5b-43a3-8806-a0d9936447ee/documents/a47ac0f3-b234-48ee-9215-046fbefa5827_9265f001-c514-4c73-a440-17561ed9e68c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, maleated, calcium salts",91722-01-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e34a485-6b5b-43a3-8806-a0d9936447ee/documents/a47ac0f3-b234-48ee-9215-046fbefa5827_9265f001-c514-4c73-a440-17561ed9e68c.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, maleated, esters with glycerol",94581-16-5," Several key Guideline (OECD 408, 414, 421, & 422) studies that investigated the repeated dose toxicity potential of Rosin Adduct Esters following oral dietary exposure in rats are available. The results are summarized below:   OECD 408 1) Rosin acids and resin acids, maleated, esters with pentaerythritol (CAS# 94581-17-6): The systemic toxicity NOAEL was determined to be 3000 ppm (equivalent to mean achieved dosages of 209.1 mg/Kg bw/day for males and 248.7 mg/Kg bw/day for females), based on histopathological changes apparent in both the liver and urinary bladder in animals exposed at the 6000 ppm and 12000/15000 ppm concentration levels.   2) Resin acids and Rosin acids, fumarated, esters with pentaerythitol (CAS# 94581-15-4): The NOAEL for systemic toxicity was considered to be 18000 ppm (equivalent to a mean achieved dosage of 1090.0 mg/Kg bw/day for males and 1298.9 mg/Kg bw/day for females), based on based on the lack of adverse treatment-related effects observed through the study period.   3) RARA, fumarated, esters with glycerol (CAS# 97489-11-7): The NOAEL for systemic toxicity was determined to be 18000 ppm for female rats (equivalent to mean achieved dosages of 1482.2 mg/Kg bw/day) and 7500 ppm (equivalent to mean achieved dosages of 574.0 mg/Kg bw/day) for male rats, based on treatment-related effects observed in male rats exposed at 18000 ppm. OECD 422   1) Resin acids and rosin acids, maleated, esters with pentaerythritol (CAS# 94581-17-6): The No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be 3000 ppm (equivalent to a mean achieved dosage of 179.3 mg/Kg bw/day in males and 221.5 mg/Kg bw/day in females), based on effects on body weight gain, food consumption and adverse histopathological changes in the kidney and urinary bladder at 7500 ppm and 18000/12000 ppm.   2) Resin acids and rosin acids, fumarated, esters with glycerol (CAS# 97489-11-7): The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was determined to be 7500 ppm for either sex (equivalent to a mean achieved dosage of 432.2 mg/Kg bw/day in males and 544.4 mg/Kg bw/day in females), based on microscopic lung changes in animals of either sex treated with 18000/15000 ppm, microscopic urinary bladder changes in females treated with 18000/15000 ppm and microscopic prostate changes in males treated with 18000 or 7500 ppm.   3) Resin acids and rosin acids, fumarated, esters with pentaerythritol (CAS# 94581-15-4): The No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was established to be 300 mg/Kg/day, based on evidence of limited systemic effects (microscopic changes in the urinary bladder) observed in animals in the 1000 mg/Kg bw/day dose group.   4) Rosin, fumarated (CAS# 65997-04-8): The No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was established to be 3000 ppm (equivalent to 221-288 mg/Kg bw/d in males, and 196-292 mg/Kg bw/d in females), based on decreased food consumption and mean body weights in parental animals of both sexes at 10,000 ppm and 3000 ppm, with high dose animals also showing an increase in total bilirubin (both sexes) and decreased adrenal weight (females only).   OECD 421   1) Resin acids and rosin acids, esters with pentaerythritol (CAS# 8050-26-8): The NOAEL was determined to be 20000 ppm (equivalent to received doses of 1864 mg/Kg bw/d in males and 1757 -2054 mg/Kg bw/d in females, respectively), based on lack of adverse treatment-related effects observed on reproductive performance or other parameters evaluated in the study.   2) Rosin (CAS# 8050-09-7): The NOAEL for systemic toxicity was considered to be 1000 ppm in males (equivalent to 84 mg/Kg bw/day) and 3000 ppm in females (equivalent to 309 mg/Kg bw/day), based on reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material.    OECD 414   1) Resin acids and rosin acids, fumarated esters with glycerol (CAS# 97489-11-7): The systemic toxicity NOAEL was determined to be 7500 ppm (equivalent to a mean achieved dosage of 622.2 mg/kg bw/day), based on lower maternal body weight gain during gestation and an initial effect on food consumption observed in animals treated at the 15000 ppm concentration level. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ebb7487-99cb-4dd0-bdf4-dcce9f28fd1d/documents/e352bcd6-64bf-4228-b3f2-046b65e3c169_27368d3b-496e-43bc-9275-f6ce71f6ec6e.html,,,,,, "Resin acids and Rosin acids, maleated, esters with glycerol",94581-16-5,Not acutely toxic following oral exposure or skin contact (LD50 >2000 mg/kg bw). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ebb7487-99cb-4dd0-bdf4-dcce9f28fd1d/documents/3a104831-f336-4507-b282-f2eb8b87b995_27368d3b-496e-43bc-9275-f6ce71f6ec6e.html,,,,,, "Resin acids and Rosin acids, maleated, esters with glycerol",94581-16-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ebb7487-99cb-4dd0-bdf4-dcce9f28fd1d/documents/3a104831-f336-4507-b282-f2eb8b87b995_27368d3b-496e-43bc-9275-f6ce71f6ec6e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, maleated, esters with glycerol",94581-16-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ebb7487-99cb-4dd0-bdf4-dcce9f28fd1d/documents/3a104831-f336-4507-b282-f2eb8b87b995_27368d3b-496e-43bc-9275-f6ce71f6ec6e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, maleated, esters with pentaerythritol",94581-17-6," Several key Guideline (OECD 408, 414, 421, & 422) studies that investigated the repeated dose toxicity potential of Rosin Adduct Esters following oral dietary exposure in rats are available. The results are summarized below:   OECD 408 1) Rosin acids and resin acids, maleated, esters with pentaerythritol (CAS# 94581-17-6): The systemic toxicity NOAEL was determined to be 3000 ppm (equivalent to mean achieved dosages of 209.1 mg/Kg bw/day for males and 248.7 mg/Kg bw/day for females), based on histopathological changes apparent in both the liver and urinary bladder in animals exposed at the 6000 ppm and 12000/15000 ppm concentration levels.   2) Resin acids and Rosin acids, fumarated, esters with pentaerythitol (CAS# 94581-15-4): The NOAEL for systemic toxicity was considered to be 18000 ppm (equivalent to a mean achieved dosage of 1090.0 mg/Kg bw/day for males and 1298.9 mg/Kg bw/day for females), based on based on the lack of adverse treatment-related effects observed through the study period.   3) RARA, fumarated, esters with glycerol (CAS# 97489-11-7): The NOAEL for systemic toxicity was determined to be 18000 ppm for female rats (equivalent to mean achieved dosages of 1482.2 mg/Kg bw/day) and 7500 ppm (equivalent to mean achieved dosages of 574.0 mg/Kg bw/day) for male rats, based on treatment-related effects observed in male rats exposed at 18000 ppm. OECD 422   1) Resin acids and rosin acids, maleated, esters with pentaerythritol (CAS# 94581-17-6): The No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be 3000 ppm (equivalent to a mean achieved dosage of 179.3 mg/Kg bw/day in males and 221.5 mg/Kg bw/day in females), based on effects on body weight gain, food consumption and adverse histopathological changes in the kidney and urinary bladder at 7500 ppm and 18000/12000 ppm.   2) Resin acids and rosin acids, fumarated, esters with glycerol (CAS# 97489-11-7): The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was determined to be 7500 ppm for either sex (equivalent to a mean achieved dosage of 432.2 mg/Kg bw/day in males and 544.4 mg/Kg bw/day in females), based on microscopic lung changes in animals of either sex treated with 18000/15000 ppm, microscopic urinary bladder changes in females treated with 18000/15000 ppm and microscopic prostate changes in males treated with 18000 or 7500 ppm.   3) Resin acids and rosin acids, fumarated, esters with pentaerythritol (CAS# 94581-15-4): The No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was established to be 300 mg/Kg/day, based on evidence of limited systemic effects (microscopic changes in the urinary bladder) observed in animals in the 1000 mg/Kg bw/day dose group.   4) Rosin, fumarated (CAS# 65997-04-8): The No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was established to be 3000 ppm (equivalent to 221-288 mg/Kg bw/d in males, and 196-292 mg/Kg bw/d in females), based on decreased food consumption and mean body weights in parental animals of both sexes at 10,000 ppm and 3000 ppm, with high dose animals also showing an increase in total bilirubin (both sexes) and decreased adrenal weight (females only).   OECD 421   1) Resin acids and rosin acids, esters with pentaerythritol (CAS# 8050-26-8): The NOAEL was determined to be 20000 ppm (equivalent to received doses of 1864 mg/Kg bw/d in males and 1757 -2054 mg/Kg bw/d in females, respectively), based on lack of adverse treatment-related effects observed on reproductive performance or other parameters evaluated in the study.   2) Rosin (CAS# 8050-09-7): The NOAEL for systemic toxicity was considered to be 1000 ppm in males (equivalent to 84 mg/Kg bw/day) and 3000 ppm in females (equivalent to 309 mg/Kg bw/day), based on reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material.    OECD 414   1) Resin acids and rosin acids, fumarated esters with glycerol (CAS# 97489-11-7): The systemic toxicity NOAEL was determined to be 7500 ppm (equivalent to a mean achieved dosage of 622.2 mg/kg bw/day), based on lower maternal body weight gain during gestation and an initial effect on food consumption observed in animals treated at the 15000 ppm concentration level. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1aa9d4a7-078b-4b47-a107-32c87a964d8c/documents/c4739dd5-ec91-4f4e-9750-09945179dd37_358a78a1-ca4c-475b-a30c-7766714de2dc.html,,,,,, "Resin acids and Rosin acids, maleated, esters with pentaerythritol",94581-17-6,Not acutely toxic following oral exposure or skin contact (LD50 >2000 mg/kg bw). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aa9d4a7-078b-4b47-a107-32c87a964d8c/documents/61fde0f6-1197-4f0d-89e2-73e5adf27d1d_358a78a1-ca4c-475b-a30c-7766714de2dc.html,,,,,, "Resin acids and Rosin acids, maleated, esters with pentaerythritol",94581-17-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aa9d4a7-078b-4b47-a107-32c87a964d8c/documents/61fde0f6-1197-4f0d-89e2-73e5adf27d1d_358a78a1-ca4c-475b-a30c-7766714de2dc.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, maleated, esters with pentaerythritol",94581-17-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1aa9d4a7-078b-4b47-a107-32c87a964d8c/documents/61fde0f6-1197-4f0d-89e2-73e5adf27d1d_358a78a1-ca4c-475b-a30c-7766714de2dc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, maleated, potassium salts",85409-27-4," Several key Guideline (OECD 408, 414, & 422) studies that investigated the repeated dose toxicity potential of Rosin Adducts and Rosin Adducts Salts following oral dietary exposure in rats are available. The results are summarized below:   OECD 408   1) Rosin, Maleated (CAS# 8050-28-0): The No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be 1500 ppm (equivalent to a mean achieved dosage of 99.5 and 120.4 mg/Kg bw/day for males and females respectively due to reduced bodyweight gains and food consumption and adverse histopathological changes in the urinary bladder of both sexes exposed to a dietary concentration of 3000 ppm of the test material.   2) Rosin, Fumarated (CAS# 65997-04-8): The No Observed Adverse Effect Level (NOAEL) for systemic toxicity for both sexes was determined to be 10000 ppm (equivalent to a mean achieved dosage of 704.6 mg/kg bw/day for males and 843.4 mg/kg bw/day for females), based on a lack of adverse treatment-related effects observed at the highest concentration tested.   OECD 422   1) Rosin, Maleated (CAS# 8050-28-0): The No Observed Adverse Effect Level (NOAEL) for systemic toxicity for both sexes was considered to be 3500 ppm, based on effects on food consumption, food efficiency, body weight, and body weight gain observed at 7000 ppm.   2) Rosin, Fumarated (CAS# 65997-04-8): The No Observed Effect Level (NOEL) for systemic toxicity for both sexes was determined to be 1000 ppm (males 72 -97 mg/Kg bw/d; females 79 -108 mg/Kg bw/d), based on toxicity observed at levels of 3000 and 10000 ppm, with a decrease in mean body weight at both doses and sexes, an increase in total bilirubin in both sexes at 10000 ppm and a decrease in adrenal gland weight in females at 10000 ppm.   OECD 414    1) Rosin, Maleated (CAS# 8050-28-0): The No Observed Effect Level (NOEL) for the pregnant dam was determined to be 500 ppm (equivalent to an achieved dosage of approximately 41.2 mg/Kg bw/day of the test material). The No Observed Adverse Effect Level (NOAEL) for the pregnant dam was considered to be a dietary exposure to 1500 ppm (equivalent to an achieved dosage of approximately 122.9 mg/Kg bw/day of the test material), based on effects observed on body weight gain and food consumption at a dietary concentration of 3000 ppm. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/70535d7a-659f-46a1-bd29-3ccc1a9b9e8b/documents/fd08ec05-d9c0-40b6-ae56-9f6d463be986_ce10dbc0-1b52-4e7f-8176-279b52498eb3.html,,,,,, "Resin acids and Rosin acids, maleated, potassium salts",85409-27-4,Not acutely toxic following oral exposure or skin contact (LD50 >2000 mg/kg bw). A low vapour pressure indicates that inhalation exposure is unlikely. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70535d7a-659f-46a1-bd29-3ccc1a9b9e8b/documents/0a107b0c-1b0c-44ad-a47e-15789c6dacc2_ce10dbc0-1b52-4e7f-8176-279b52498eb3.html,,,,,, "Resin acids and Rosin acids, maleated, potassium salts",85409-27-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70535d7a-659f-46a1-bd29-3ccc1a9b9e8b/documents/0a107b0c-1b0c-44ad-a47e-15789c6dacc2_ce10dbc0-1b52-4e7f-8176-279b52498eb3.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, maleated, potassium salts",85409-27-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70535d7a-659f-46a1-bd29-3ccc1a9b9e8b/documents/0a107b0c-1b0c-44ad-a47e-15789c6dacc2_ce10dbc0-1b52-4e7f-8176-279b52498eb3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, manganese salts",9008-34-8," Several key guideline (OECD 408, 414, 421, & 422 ) studies that investigated the repeated dose toxicity potential of Rosin; Rosin, hydrogenated; Rosin, oligomers; and Rosin, reaction products with formaldehyde following oral dietary exposure in rats are available. The results are summarized below: OECD 408 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL was determined to be 5000 ppm (equivalent to a mean achieved dosage of 335.2 mg/kg bw/day for males and 401.2 mg/kg bw/day for females) based on reduced body weight gains in animals of either sex exposed to 7500 ppm. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The NOAEL for systemic toxicity of Rosin, reaction products with formaldehyde was considered to be 3000 ppm (equivalent to mean achieved dosages of approximately 213.1 mg/kg bw/day or 255.2 mg/kg bw/day for males and females, respectively), based on the effects on body weight, body weight gain and, to a lesser extent, food consumption, observed among females exposed to diets containing 7500 ppm of the test material for ninety days. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): Based on a lack of adverse treatment-related effects observed at the highest concentration tested, the systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 6000 ppm for either sex (equivalent to a mean achieved dosage of 334.5 mg/kg bw/day for males and 399.8 mg/kg bw/day for females). OECD 414 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 2500 ppm (equivalent to a mean achieved dosage of 199.3 mg/kg bw/day) based on lower maternal body weight gain during gestation and an initial effect on food consumption at 7500 ppm and lower maternal body weight gain at 5000 ppm. OECD 421 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 1000 ppm in males (equivalent to 84 mg/kg bw/d) and 3000 ppm in females (equivalent to 309 mg/kg bw/d) based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material. OECD 422 1) Rosin (CAS# 8050 -09 -7): In a key combined repeated dose, reproductive/developmental toxicity screening study (Harlan Laboratories Ltd, 2015a), the sytemic toxicity NOAEL for Tall oil rosin was determined to be 5000 ppm. In another key combined repeated dose, reproductive/developmental toxicity study (Harlan Laboratories Ltd., 2014a), the systemic toxicity NOAEL for Gum Rosin was determined to be 2500 ppm. A NOEL (No Observed Effect Level) for general toxicity could not be established due to effects on body weights at all dose levels in females during the lactation period. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The systemic toxicity NOAEL for Rosin, reaction product with formaldehyde was determined to be 10000 ppm and the NOEL was established at a concentration of 1000 ppm. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): The systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 3000 ppm. Based on the histopathological changes observed in adrenal glands, no NOEL for systemic toxicity was established for females whereas for males it was at the dose level of 1000 ppm. 4) Rosin, oligomers: The systemic toxicity NOAEL for Rosin, oligomers in male rats was determined to be 7500 ppm, based on statistically significant body weight and body weight gain effects observed at the 15000 ppm concentration level. The systemic toxicity NOAEL for female rats was determined to be 3000 ppm, based on effects on body weight and body weight gain in females exposed to the test material at 7500 and 15000 ppm. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/56dc45f6-822e-4621-a06c-572a8b2eca3a/documents/85c67290-1dc0-436d-b97b-e470c99224d2_657fb0a1-ec10-4b71-b27d-a6b74d5ef48b.html,,,,,, "Resin acids and Rosin acids, manganese salts",9008-34-8,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56dc45f6-822e-4621-a06c-572a8b2eca3a/documents/2c860506-1270-4bdf-94db-87bac2e99c29_657fb0a1-ec10-4b71-b27d-a6b74d5ef48b.html,,,,,, "Resin acids and Rosin acids, manganese salts",9008-34-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56dc45f6-822e-4621-a06c-572a8b2eca3a/documents/2c860506-1270-4bdf-94db-87bac2e99c29_657fb0a1-ec10-4b71-b27d-a6b74d5ef48b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, manganese salts",9008-34-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/56dc45f6-822e-4621-a06c-572a8b2eca3a/documents/2c860506-1270-4bdf-94db-87bac2e99c29_657fb0a1-ec10-4b71-b27d-a6b74d5ef48b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Esters of rosin oligomers with glycerol,68475-37-6," Information is available on the oral repeated dose toxicity of Rosin esters (simple, linear, and bulky). No treatment-related or biologically relevant findings were apparent in rats following oral sub-chronic dietary exposure to Resin acids and rosin acids, esters with glycerol, Resin acids and rosin acids, esters with ethylene glycol, Resin acids and rosin acids, esters with triethylene glycol, Resin acids and rosin acids, hydrogenated, esters with glycerol and Resin acids and rosin acids, hydrogenated, esters with pentaerythritol. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/84a93420-ac2b-4cdf-90b1-8bf14ed57d21/documents/94fbe6cb-5500-4f13-9048-55d55b472091_c4981e81-4851-4727-aaa1-7b356c0eef1b.html,,,,,, Esters of rosin oligomers with glycerol,68475-37-6,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84a93420-ac2b-4cdf-90b1-8bf14ed57d21/documents/47f39a7f-b7f6-4f8e-a04a-7f9e59f315e2_c4981e81-4851-4727-aaa1-7b356c0eef1b.html,,,,,, Esters of rosin oligomers with glycerol,68475-37-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84a93420-ac2b-4cdf-90b1-8bf14ed57d21/documents/47f39a7f-b7f6-4f8e-a04a-7f9e59f315e2_c4981e81-4851-4727-aaa1-7b356c0eef1b.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Esters of rosin oligomers with glycerol,68475-37-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/84a93420-ac2b-4cdf-90b1-8bf14ed57d21/documents/47f39a7f-b7f6-4f8e-a04a-7f9e59f315e2_c4981e81-4851-4727-aaa1-7b356c0eef1b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Esters of rosin oligomers with pentaerythritol,65997-12-8," Information is available on the oral repeated dose toxicity of Rosin esters (simple, linear, and bulky). No treatment-related or biologically relevant findings were apparent in rats following oral sub-chronic dietary exposure to Resin acids and rosin acids, esters with glycerol, Resin acids and rosin acids, esters with ethylene glycol, Resin acids and rosin acids, esters with triethylene glycol, Resin acids and rosin acids, hydrogenated, esters with glycerol and Resin acids and rosin acids, hydrogenated, esters with pentaerythritol. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ebd246f2-ada9-4c23-95fb-2171453c7bb4/documents/23144bb9-89f5-4a88-82cb-e470c38a1b5f_f64858b8-d643-4ff7-a6e2-15b2d87e3c84.html,,,,,, Esters of rosin oligomers with pentaerythritol,65997-12-8,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebd246f2-ada9-4c23-95fb-2171453c7bb4/documents/c410c50e-986b-459f-b28b-72a33062883b_f64858b8-d643-4ff7-a6e2-15b2d87e3c84.html,,,,,, Esters of rosin oligomers with pentaerythritol,65997-12-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebd246f2-ada9-4c23-95fb-2171453c7bb4/documents/c410c50e-986b-459f-b28b-72a33062883b_f64858b8-d643-4ff7-a6e2-15b2d87e3c84.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Esters of rosin oligomers with pentaerythritol,65997-12-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ebd246f2-ada9-4c23-95fb-2171453c7bb4/documents/c410c50e-986b-459f-b28b-72a33062883b_f64858b8-d643-4ff7-a6e2-15b2d87e3c84.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, potassium salts",61790-50-9," Several key guideline (OECD 408, 414, 421, & 422 ) studies that investigated the repeated dose toxicity potential of Rosin; Rosin, hydrogenated; Rosin, oligomers; and Rosin, reaction products with formaldehyde following oral dietary exposure in rats are available. The results are summarized below: OECD 408 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL was determined to be 5000 ppm (equivalent to a mean achieved dosage of 335.2 mg/kg bw/day for males and 401.2 mg/kg bw/day for females) based on reduced body weight gains in animals of either sex exposed to 7500 ppm. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The NOAEL for systemic toxicity of Rosin, reaction products with formaldehyde was considered to be 3000 ppm (equivalent to mean achieved dosages of approximately 213.1 mg/kg bw/day or 255.2 mg/kg bw/day for males and females, respectively), based on the effects on body weight, body weight gain and, to a lesser extent, food consumption, observed among females exposed to diets containing 7500 ppm of the test material for ninety days. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): Based on a lack of adverse treatment-related effects observed at the highest concentration tested, the systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 6000 ppm for either sex (equivalent to a mean achieved dosage of 334.5 mg/kg bw/day for males and 399.8 mg/kg bw/day for females). OECD 414 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 2500 ppm (equivalent to a mean achieved dosage of 199.3 mg/kg bw/day) based on lower maternal body weight gain during gestation and an initial effect on food consumption at 7500 ppm and lower maternal body weight gain at 5000 ppm. OECD 421 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 1000 ppm in males (equivalent to 84 mg/kg bw/d) and 3000 ppm in females (equivalent to 309 mg/kg bw/d) based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material. OECD 422 1) Rosin (CAS# 8050 -09 -7): In a key combined repeated dose, reproductive/developmental toxicity screening study (Harlan Laboratories Ltd, 2015a), the sytemic toxicity NOAEL for Tall oil rosin was determined to be 5000 ppm. In another key combined repeated dose, reproductive/developmental toxicity study (Harlan Laboratories Ltd., 2014a), the systemic toxicity NOAEL for Gum Rosin was determined to be 2500 ppm. A NOEL (No Observed Effect Level) for general toxicity could not be established due to effects on body weights at all dose levels in females during the lactation period. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The systemic toxicity NOAEL for Rosin, reaction product with formaldehyde was determined to be 10000 ppm and the NOEL was established at a concentration of 1000 ppm. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): The systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 3000 ppm. Based on the histopathological changes observed in adrenal glands, no NOEL for systemic toxicity was established for females whereas for males it was at the dose level of 1000 ppm. 4) Rosin, oligomers: The systemic toxicity NOAEL for Rosin, oligomers in male rats was determined to be 7500 ppm, based on statistically significant body weight and body weight gain effects observed at the 15000 ppm concentration level. The systemic toxicity NOAEL for female rats was determined to be 3000 ppm, based on effects on body weight and body weight gain in females exposed to the test material at 7500 and 15000 ppm. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d30db8f6-fed9-416a-8e39-d60164e85d80/documents/14c3b74c-13b4-4c81-8444-5c3624410972_871c0ade-2885-446f-b94d-3e3dd6892b79.html,,,,,, "Resin acids and Rosin acids, potassium salts",61790-50-9,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d30db8f6-fed9-416a-8e39-d60164e85d80/documents/1e4e887b-e93d-4fac-8dfb-93dbe0dc58e0_871c0ade-2885-446f-b94d-3e3dd6892b79.html,,,,,, "Resin acids and Rosin acids, potassium salts",61790-50-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d30db8f6-fed9-416a-8e39-d60164e85d80/documents/1e4e887b-e93d-4fac-8dfb-93dbe0dc58e0_871c0ade-2885-446f-b94d-3e3dd6892b79.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, potassium salts",61790-50-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d30db8f6-fed9-416a-8e39-d60164e85d80/documents/1e4e887b-e93d-4fac-8dfb-93dbe0dc58e0_871c0ade-2885-446f-b94d-3e3dd6892b79.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, reaction products with formaldehyde, potassium salt",92129-53-8," Several key guideline (OECD 408, 414, 421, & 422 ) studies that investigated the repeated dose toxicity potential of Rosin; Rosin, hydrogenated; Rosin, oligomers; and Rosin, reaction products with formaldehyde following oral dietary exposure in rats are available. The results are summarized below: OECD 408 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL was determined to be 5000 ppm (equivalent to a mean achieved dosage of 335.2 mg/kg bw/day for males and 401.2 mg/kg bw/day for females) based on reduced body weight gains in animals of either sex exposed to 7500 ppm. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The NOAEL for systemic toxicity of Rosin, reaction products with formaldehyde was considered to be 3000 ppm (equivalent to mean achieved dosages of approximately 213.1 mg/kg bw/day or 255.2 mg/kg bw/day for males and females, respectively), based on the effects on body weight, body weight gain and, to a lesser extent, food consumption, observed among females exposed to diets containing 7500 ppm of the test material for ninety days. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): Based on a lack of adverse treatment-related effects observed at the highest concentration tested, the systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 6000 ppm for either sex (equivalent to a mean achieved dosage of 334.5 mg/kg bw/day for males and 399.8 mg/kg bw/day for females). OECD 414 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 2500 ppm (equivalent to a mean achieved dosage of 199.3 mg/kg bw/day) based on lower maternal body weight gain during gestation and an initial effect on food consumption at 7500 ppm and lower maternal body weight gain at 5000 ppm. OECD 421 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 1000 ppm in males (equivalent to 84 mg/kg bw/d) and 3000 ppm in females (equivalent to 309 mg/kg bw/d) based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material. OECD 422 1) Rosin (CAS# 8050 -09 -7): In a key combined repeated dose, reproductive/developmental toxicity screening study (Harlan Laboratories Ltd, 2015a), the sytemic toxicity NOAEL for Tall oil rosin was determined to be 5000 ppm. In another key combined repeated dose, reproductive/developmental toxicity study (Harlan Laboratories Ltd., 2014a), the systemic toxicity NOAEL for Gum Rosin was determined to be 2500 ppm. A NOEL (No Observed Effect Level) for general toxicity could not be established due to effects on body weights at all dose levels in females during the lactation period. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The systemic toxicity NOAEL for Rosin, reaction product with formaldehyde was determined to be 10000 ppm and the NOEL was established at a concentration of 1000 ppm. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): The systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 3000 ppm. Based on the histopathological changes observed in adrenal glands, no NOEL for systemic toxicity was established for females whereas for males it was at the dose level of 1000 ppm. 4) Rosin, oligomers: The systemic toxicity NOAEL for Rosin, oligomers in male rats was determined to be 7500 ppm, based on statistically significant body weight and body weight gain effects observed at the 15000 ppm concentration level. The systemic toxicity NOAEL for female rats was determined to be 3000 ppm, based on effects on body weight and body weight gain in females exposed to the test material at 7500 and 15000 ppm. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9927952-6590-42d4-a103-f8193186ee2b/documents/21e5813b-da4c-446a-8946-82a55230f0f7_f17d7a35-9fc4-4c6c-9059-01eccd33e6cb.html,,,,,, "Resin acids and Rosin acids, reaction products with formaldehyde, potassium salt",92129-53-8,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9927952-6590-42d4-a103-f8193186ee2b/documents/d41a961d-43db-45bd-bd25-9ff77fcdb368_f17d7a35-9fc4-4c6c-9059-01eccd33e6cb.html,,,,,, "Resin acids and Rosin acids, reaction products with formaldehyde, potassium salt",92129-53-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9927952-6590-42d4-a103-f8193186ee2b/documents/d41a961d-43db-45bd-bd25-9ff77fcdb368_f17d7a35-9fc4-4c6c-9059-01eccd33e6cb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, reaction products with formaldehyde, potassium salt",92129-53-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9927952-6590-42d4-a103-f8193186ee2b/documents/d41a961d-43db-45bd-bd25-9ff77fcdb368_f17d7a35-9fc4-4c6c-9059-01eccd33e6cb.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, reaction products with formaldehyde, sodium salts",91081-28-6," Several key guideline (OECD 408, 414, 421, & 422 ) studies that investigated the repeated dose toxicity potential of Rosin; Rosin, hydrogenated; Rosin, oligomers; and Rosin, reaction products with formaldehyde following oral dietary exposure in rats are available. The results are summarized below: OECD 408 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL was determined to be 5000 ppm (equivalent to a mean achieved dosage of 335.2 mg/kg bw/day for males and 401.2 mg/kg bw/day for females) based on reduced body weight gains in animals of either sex exposed to 7500 ppm. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The NOAEL for systemic toxicity of Rosin, reaction products with formaldehyde was considered to be 3000 ppm (equivalent to mean achieved dosages of approximately 213.1 mg/kg bw/day or 255.2 mg/kg bw/day for males and females, respectively), based on the effects on body weight, body weight gain and, to a lesser extent, food consumption, observed among females exposed to diets containing 7500 ppm of the test material for ninety days. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): Based on a lack of adverse treatment-related effects observed at the highest concentration tested, the systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 6000 ppm for either sex (equivalent to a mean achieved dosage of 334.5 mg/kg bw/day for males and 399.8 mg/kg bw/day for females). OECD 414 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 2500 ppm (equivalent to a mean achieved dosage of 199.3 mg/kg bw/day) based on lower maternal body weight gain during gestation and an initial effect on food consumption at 7500 ppm and lower maternal body weight gain at 5000 ppm. OECD 421 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 1000 ppm in males (equivalent to 84 mg/kg bw/d) and 3000 ppm in females (equivalent to 309 mg/kg bw/d) based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material. OECD 422 1) Rosin (CAS# 8050 -09 -7): In a key combined repeated dose, reproductive/developmental toxicity screening study (Harlan Laboratories Ltd, 2015a), the sytemic toxicity NOAEL for Tall oil rosin was determined to be 5000 ppm. In another key combined repeated dose, reproductive/developmental toxicity study (Harlan Laboratories Ltd., 2014a), the systemic toxicity NOAEL for Gum Rosin was determined to be 2500 ppm. A NOEL (No Observed Effect Level) for general toxicity could not be established due to effects on body weights at all dose levels in females during the lactation period. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The systemic toxicity NOAEL for Rosin, reaction product with formaldehyde was determined to be 10000 ppm and the NOEL was established at a concentration of 1000 ppm. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): The systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 3000 ppm. Based on the histopathological changes observed in adrenal glands, no NOEL for systemic toxicity was established for females whereas for males it was at the dose level of 1000 ppm. 4) Rosin, oligomers: The systemic toxicity NOAEL for Rosin, oligomers in male rats was determined to be 7500 ppm, based on statistically significant body weight and body weight gain effects observed at the 15000 ppm concentration level. The systemic toxicity NOAEL for female rats was determined to be 3000 ppm, based on effects on body weight and body weight gain in females exposed to the test material at 7500 and 15000 ppm. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a7c3971-26ef-4216-b148-1a04c1db531f/documents/b6127b7b-6bed-4af8-8373-d43d340e4721_0340f1da-39a0-4b72-b3c6-04e28a452bc1.html,,,,,, "Resin acids and Rosin acids, reaction products with formaldehyde, sodium salts",91081-28-6,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a7c3971-26ef-4216-b148-1a04c1db531f/documents/a28f73b8-a890-4840-88e5-e41ef26a7a4f_0340f1da-39a0-4b72-b3c6-04e28a452bc1.html,,,,,, "Resin acids and Rosin acids, reaction products with formaldehyde, sodium salts",91081-28-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a7c3971-26ef-4216-b148-1a04c1db531f/documents/a28f73b8-a890-4840-88e5-e41ef26a7a4f_0340f1da-39a0-4b72-b3c6-04e28a452bc1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, reaction products with formaldehyde, sodium salts",91081-28-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a7c3971-26ef-4216-b148-1a04c1db531f/documents/a28f73b8-a890-4840-88e5-e41ef26a7a4f_0340f1da-39a0-4b72-b3c6-04e28a452bc1.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, sodium salts",61790-51-0," Several key guideline (OECD 408, 414, 421, & 422 ) studies that investigated the repeated dose toxicity potential of Rosin; Rosin, hydrogenated; Rosin, oligomers; and Rosin, reaction products with formaldehyde following oral dietary exposure in rats are available. The results are summarized below: OECD 408 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL was determined to be 5000 ppm (equivalent to a mean achieved dosage of 335.2 mg/kg bw/day for males and 401.2 mg/kg bw/day for females) based on reduced body weight gains in animals of either sex exposed to 7500 ppm. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The NOAEL for systemic toxicity of Rosin, reaction products with formaldehyde was considered to be 3000 ppm (equivalent to mean achieved dosages of approximately 213.1 mg/kg bw/day or 255.2 mg/kg bw/day for males and females, respectively), based on the effects on body weight, body weight gain and, to a lesser extent, food consumption, observed among females exposed to diets containing 7500 ppm of the test material for ninety days. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): Based on a lack of adverse treatment-related effects observed at the highest concentration tested, the systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 6000 ppm for either sex (equivalent to a mean achieved dosage of 334.5 mg/kg bw/day for males and 399.8 mg/kg bw/day for females). OECD 414 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 2500 ppm (equivalent to a mean achieved dosage of 199.3 mg/kg bw/day) based on lower maternal body weight gain during gestation and an initial effect on food consumption at 7500 ppm and lower maternal body weight gain at 5000 ppm. OECD 421 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 1000 ppm in males (equivalent to 84 mg/kg bw/d) and 3000 ppm in females (equivalent to 309 mg/kg bw/d) based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material. OECD 422 1) Rosin (CAS# 8050 -09 -7): In a key combined repeated dose, reproductive/developmental toxicity screening study (Harlan Laboratories Ltd, 2015a), the sytemic toxicity NOAEL for Tall oil rosin was determined to be 5000 ppm. In another key combined repeated dose, reproductive/developmental toxicity study (Harlan Laboratories Ltd., 2014a), the systemic toxicity NOAEL for Gum Rosin was determined to be 2500 ppm. A NOEL (No Observed Effect Level) for general toxicity could not be established due to effects on body weights at all dose levels in females during the lactation period. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The systemic toxicity NOAEL for Rosin, reaction product with formaldehyde was determined to be 10000 ppm and the NOEL was established at a concentration of 1000 ppm. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): The systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 3000 ppm. Based on the histopathological changes observed in adrenal glands, no NOEL for systemic toxicity was established for females whereas for males it was at the dose level of 1000 ppm. 4) Rosin, oligomers: The systemic toxicity NOAEL for Rosin, oligomers in male rats was determined to be 7500 ppm, based on statistically significant body weight and body weight gain effects observed at the 15000 ppm concentration level. The systemic toxicity NOAEL for female rats was determined to be 3000 ppm, based on effects on body weight and body weight gain in females exposed to the test material at 7500 and 15000 ppm. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/260d571e-846d-440a-b033-72bb701dde80/documents/1fb2db22-4ec9-4aac-ad9f-c8ef779506e3_d48831e1-916c-405d-b585-51b9b2c26571.html,,,,,, "Resin acids and Rosin acids, sodium salts",61790-51-0,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/260d571e-846d-440a-b033-72bb701dde80/documents/88eb0625-9eb0-42ed-9114-ee1b4b0c7356_d48831e1-916c-405d-b585-51b9b2c26571.html,,,,,, "Resin acids and Rosin acids, sodium salts",61790-51-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/260d571e-846d-440a-b033-72bb701dde80/documents/88eb0625-9eb0-42ed-9114-ee1b4b0c7356_d48831e1-916c-405d-b585-51b9b2c26571.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Resin acids and Rosin acids, sodium salts",61790-51-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/260d571e-846d-440a-b033-72bb701dde80/documents/88eb0625-9eb0-42ed-9114-ee1b4b0c7356_d48831e1-916c-405d-b585-51b9b2c26571.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Rhenium,7440-15-5,"Since no substance-specific data are available, a read-across approach from ammonium perrhenate is considered appropriate. Details are provided in the Read Across Justification Document, attached in IUCLID Section 13.A (limited) acute oral toxicity study with ammonium perrhenate determined an LD50 as >2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/152a87e5-0d21-4cfa-8103-218fe0143c93/documents/582a4647-01e8-46e8-9dc7-7adf69c911f8_00d32c44-7fdd-4af5-98d9-c71c95e9274a.html,,,,,, Rhenium,7440-15-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/152a87e5-0d21-4cfa-8103-218fe0143c93/documents/582a4647-01e8-46e8-9dc7-7adf69c911f8_00d32c44-7fdd-4af5-98d9-c71c95e9274a.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Rhodium,7440-16-6," No relevant acute oral, dermal or inhalation toxicity data were identified with Rhodium. The substance is considered to fall withing the scope of the read-across category ‘Rhodium and Dirhodium trioxide'.  In an OECD guideline study conducted to GLP, the acute oral LD50 of dirhodium trioxide was found to exceed 2000 mg/kg bw in female rats. Based on this experimental evidence, rhodium is considered to have an LD50>2000 mg/kg bw and thus not meeting the classification criteria for acute toxicity(oral). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): OECD guideline and GLP compliant study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/421b2eb5-2402-40ec-98d1-10cbaa49d624/documents/44714fce-dc91-433b-86e3-e013bc38f500_eb3c284b-747e-4763-81e4-18113b4ca2b9.html,,,,,, Rhodium acetate,42204-14-8,"The acute oral LD50 of rhodium (III) acetate “brown” was found to be >5000 and 4799 mg/kg bw in male and female rats, respectively (Mayr, 1986a).The acute dermal LD50 of rhodium (III) acetate “brown” was found to be >2000 mg/kg bw in rabbits (Mayr, 1986b).No relevant acute inhalation toxicity data were identified, or are required at this tonnage. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18c6630a-18ef-4653-9502-1eba5215ccae/documents/IUC5-65a56827-8421-4f16-adcd-e6cdf2d6d200_7d30af7b-26c2-42c2-9b66-3e9e7c3167cf.html,,,,,, Rhodium acetate,42204-14-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18c6630a-18ef-4653-9502-1eba5215ccae/documents/IUC5-65a56827-8421-4f16-adcd-e6cdf2d6d200_7d30af7b-26c2-42c2-9b66-3e9e7c3167cf.html,,oral,LD50,"4,799 mg/kg bw",no adverse effect observed, Rhodium acetate,42204-14-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18c6630a-18ef-4653-9502-1eba5215ccae/documents/IUC5-65a56827-8421-4f16-adcd-e6cdf2d6d200_7d30af7b-26c2-42c2-9b66-3e9e7c3167cf.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Rhodium chloride (RhCl3), hydrate",20765-98-4,"In a guideline acute oral toxicity study, conducted to GLP, respective LD50 values of 753 and 1257 mg/kg bw were reported in female and male rats following gavage administration of rhodium trichloride (hydrate) (Mayr, 1986a).The acute dermal LD50 of rhodium (III) chloride hydrate was found to exceed 2000 mg/kg bw following a 24-hour occlusive application in rabbits (Mayr, 1986b).No relevant acute inhalation toxicity data were identified, or are required at this tonnage. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af465955-7d55-4cb5-8ad1-2e1634af748a/documents/IUC5-ca4ada24-c8a2-477c-a7a5-f32aac9cf208_1411eaf0-5ebf-4a21-b6c3-8a6b36ea6acc.html,,,,,, "Rhodium chloride (RhCl3), hydrate",20765-98-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af465955-7d55-4cb5-8ad1-2e1634af748a/documents/IUC5-ca4ada24-c8a2-477c-a7a5-f32aac9cf208_1411eaf0-5ebf-4a21-b6c3-8a6b36ea6acc.html,,oral,LD50,753 mg/kg bw,adverse effect observed, "Rhodium chloride (RhCl3), hydrate",20765-98-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af465955-7d55-4cb5-8ad1-2e1634af748a/documents/IUC5-ca4ada24-c8a2-477c-a7a5-f32aac9cf208_1411eaf0-5ebf-4a21-b6c3-8a6b36ea6acc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Rhodium trinitrate,10139-58-9," In an OECD Test Guideline 423 study, to GLP, the acute oral LD50 value of rhodium trinitrate hydrate was determined to range between 200 and 2000 mg/kg bw following gavage administration in rats (van Huygevoort, 2003a).   No relevant acute dermal or inhalation toxicity data were identified, or are required at this tonnage. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b969ddcf-cd4c-4ae0-a80a-00862f10bd59/documents/79bd625c-552c-4ea3-8157-2ccc8336d7d9_92b24ec9-7b74-42fd-b24e-531061e6458d.html,,,,,, Rhodium trinitrate,10139-58-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b969ddcf-cd4c-4ae0-a80a-00862f10bd59/documents/79bd625c-552c-4ea3-8157-2ccc8336d7d9_92b24ec9-7b74-42fd-b24e-531061e6458d.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, Rhodium tris(2-ethylhexanoate),20845-92-5,No acute toxicity testing was performed since the substance is classified as skin corrosive. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7627fa79-e3e4-4a20-8c89-0980ab38573f/documents/386419e1-7b0b-4a43-86a8-203f8ae735d6_eafbd6e1-24c2-4487-bcb9-eaced9ddcace.html,,,,,, "Rifamycin, 3-amino-1,4-dideoxy-1,4-dihydro-1,4-dioxo-(9Cl)",51756-80-0, Oral: The oral LD50 value of the test item in Wistar rat was established to exceed 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70d724b1-4454-458b-8e32-e9f17177158a/documents/9303238f-319c-4829-aa92-3a01366f52f4_2bda6bf2-13a7-41a6-8e3a-5227c882043d.html,,,,,, "Rifamycin, 3-amino-1,4-dideoxy-1,4-dihydro-1,4-dioxo-(9Cl)",51756-80-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70d724b1-4454-458b-8e32-e9f17177158a/documents/9303238f-319c-4829-aa92-3a01366f52f4_2bda6bf2-13a7-41a6-8e3a-5227c882043d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Rifamycin, 3-amino-1,4-dideoxy-1,4-dihydro-4-imino-1-oxo-",62041-01-4, Oral: The oral LD50 value of the test item in Wistar rat was established to exceed 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80d62c2c-7623-4d82-bcea-0ea49a860402/documents/0eab89e8-7b4c-4e13-b7f1-b89a5d3cd269_875cc3a7-6ecc-49de-b134-04c0ff98466f.html,,,,,, "Rifamycin, 3-amino-1,4-dideoxy-1,4-dihydro-4-imino-1-oxo-",62041-01-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80d62c2c-7623-4d82-bcea-0ea49a860402/documents/0eab89e8-7b4c-4e13-b7f1-b89a5d3cd269_875cc3a7-6ecc-49de-b134-04c0ff98466f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, 4-(6-acryloyloxyhexyloxy)-benzoic acid (4-cyanophenyl ester),83847-14-7,GLP compliant OECD 401: LD50 (oral) > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54953334-94f5-4839-82d0-221b958df41c/documents/c5f5ae6f-2934-4c68-8cd3-a0979b870fdb_5e9e2dba-4453-4cee-9861-8fe9671d4985.html,,,,,, 4-(6-acryloyloxyhexyloxy)-benzoic acid (4-cyanophenyl ester),83847-14-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54953334-94f5-4839-82d0-221b958df41c/documents/c5f5ae6f-2934-4c68-8cd3-a0979b870fdb_5e9e2dba-4453-4cee-9861-8fe9671d4985.html,,oral,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, "Rosin, decarboxylated",8050-18-8," The potential for acute oral toxicity of the test material AA-948 -61 (Decarboxylated Rosin, CAS No. 8050 -18 -8) was determined according to the OECD 423 Testing Guideline. A group of three fasted female rats received a single oral gavage dose of the test item, formulated in corn oil, at a dose level of 2000 mg/kg body weight. As results at this dose level indicated the acute lethal oral dose of the test item to be greater than 2000 mg/kg body weight, in compliance with the study guidelines, a further group of three fasted females was similarly dosed at 2000 mg/kg body weight to complete the study. During the study, clinical condition, body weight and macropathology investigations were undertaken. Under the conditions of the study, the acute median lethal oral dose (LD50) to rats of AA-948- 61 (Decarboxylated Rosin, CAS No. 8050-18-8) was demonstrated to be greater than 2000 mg/kg body weight. AA-948-61 (Decarboxylated Rosin, CAS No. 8050-18-8) is included in Category 5/Unclassified, according to the Globally Harmonised System (GHS). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f18c7b0-3e8a-4589-956a-f8f71252da33/documents/bef7bf7e-fb90-4a8b-947f-c3e21e47ad39_f4449285-897f-45c1-aaf7-a48cfdf05323.html,,,,,, "Rosin, decarboxylated",8050-18-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f18c7b0-3e8a-4589-956a-f8f71252da33/documents/bef7bf7e-fb90-4a8b-947f-c3e21e47ad39_f4449285-897f-45c1-aaf7-a48cfdf05323.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Rosin, fumarated",65997-04-8," Several key Guideline (OECD 408, 414, & 422) studies that investigated the repeated dose toxicity potential of Rosin Adducts and Rosin Adducts Salts following oral dietary exposure in rats are available. The results are summarized below:   OECD 408   1) Rosin, Maleated (CAS# 8050-28-0): The No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be 1500 ppm (equivalent to a mean achieved dosage of 99.5 and 120.4 mg/Kg bw/day for males and females respectively due to reduced bodyweight gains and food consumption and adverse histopathological changes in the urinary bladder of both sexes exposed to a dietary concentration of 3000 ppm of the test material.   2) Rosin, Fumarated (CAS# 65997-04-8): The No Observed Adverse Effect Level (NOAEL) for systemic toxicity for both sexes was determined to be 10000 ppm (equivalent to a mean achieved dosage of 704.6 mg/kg bw/day for males and 843.4 mg/kg bw/day for females), based on a lack of adverse treatment-related effects observed at the highest concentration tested.   OECD 422   1) Rosin, Maleated (CAS# 8050-28-0): The No Observed Adverse Effect Level (NOAEL) for systemic toxicity for both sexes was considered to be 3500 ppm, based on effects on food consumption, food efficiency, body weight, and body weight gain observed at 7000 ppm.   2) Rosin, Fumarated (CAS# 65997-04-8): The No Observed Effect Level (NOEL) for systemic toxicity for both sexes was determined to be 1000 ppm (males 72 -97 mg/Kg bw/d; females 79 -108 mg/Kg bw/d), based on toxicity observed at levels of 3000 and 10000 ppm, with a decrease in mean body weight at both doses and sexes, an increase in total bilirubin in both sexes at 10000 ppm and a decrease in adrenal gland weight in females at 10000 ppm.   OECD 414    1) Rosin, Maleated (CAS# 8050-28-0): The No Observed Effect Level (NOEL) for the pregnant dam was determined to be 500 ppm (equivalent to an achieved dosage of approximately 41.2 mg/Kg bw/day of the test material). The No Observed Adverse Effect Level (NOAEL) for the pregnant dam was considered to be a dietary exposure to 1500 ppm (equivalent to an achieved dosage of approximately 122.9 mg/Kg bw/day of the test material), based on effects observed on body weight gain and food consumption at a dietary concentration of 3000 ppm. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c270c6b9-977b-42a2-ab65-5a9abd723a49/documents/f9254bc1-3b06-4f82-bdfa-a62ff5bb908e_208f7100-0632-468c-a769-9097654a98b5.html,,,,,, "Rosin, fumarated",65997-04-8,Not acutely toxic following oral exposure or skin contact (LD50 >2000 mg/kg bw). A low vapour pressure indicates that inhalation exposure is unlikely. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c270c6b9-977b-42a2-ab65-5a9abd723a49/documents/0bb08d48-e3c2-4dd2-85d3-fe230797f288_208f7100-0632-468c-a769-9097654a98b5.html,,,,,, "Rosin, fumarated",65997-04-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c270c6b9-977b-42a2-ab65-5a9abd723a49/documents/0bb08d48-e3c2-4dd2-85d3-fe230797f288_208f7100-0632-468c-a769-9097654a98b5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Rosin, fumarated",65997-04-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c270c6b9-977b-42a2-ab65-5a9abd723a49/documents/0bb08d48-e3c2-4dd2-85d3-fe230797f288_208f7100-0632-468c-a769-9097654a98b5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Rosin, fumarated, reaction products with formaldehyde",95009-65-7,"A repeated dose/reproductive toxicity screening study has been performed on rosin, fumarated. Any toxicity seen was insignificant and probably due to poor palatability of the substance being investigated. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/31449e4b-43ad-4707-a219-2d8a71ae68c3/documents/IUC5-6f5dce98-d2df-4a25-afd2-2267ccc3d978_5c11bce9-f354-4acc-bba2-e0d9a4715c9d.html,,,,,, "Rosin, fumarated, reaction products with formaldehyde",95009-65-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/31449e4b-43ad-4707-a219-2d8a71ae68c3/documents/IUC5-6f5dce98-d2df-4a25-afd2-2267ccc3d978_5c11bce9-f354-4acc-bba2-e0d9a4715c9d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Rosin, fumarated, reaction products with formaldehyde",95009-65-7,"Not acutely toxic following oral exposure (LD50 >2000 mg/kg bw). Based on read-across to Rosin and Resin and Rosin acids, esters with pentaerythritol, not expected to be acutely toxic after skin contact (acute dermal LD50 >2000 mg/kg bw). Low vapour pressure precludes inhalation exposure. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31449e4b-43ad-4707-a219-2d8a71ae68c3/documents/IUC5-a56fded8-ab55-41ac-b92f-352ace27b57b_5c11bce9-f354-4acc-bba2-e0d9a4715c9d.html,,,,,, "Rosin, fumarated, reaction products with formaldehyde",95009-65-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31449e4b-43ad-4707-a219-2d8a71ae68c3/documents/IUC5-a56fded8-ab55-41ac-b92f-352ace27b57b_5c11bce9-f354-4acc-bba2-e0d9a4715c9d.html,,oral,LD50,"2,000 mg/kg bw",, "Rosin, fumarated, reaction products with formaldehyde",95009-65-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/31449e4b-43ad-4707-a219-2d8a71ae68c3/documents/IUC5-a56fded8-ab55-41ac-b92f-352ace27b57b_5c11bce9-f354-4acc-bba2-e0d9a4715c9d.html,,dermal,LD50,"2,000 mg/kg bw",, "Rosin, fumarated, reaction products with glycerol and pentaerythritol",92202-14-7," Several key Guideline (OECD 408, 414, 421, & 422) studies that investigated the repeated dose toxicity potential of Rosin Adduct Esters following oral dietary exposure in rats are available. The results are summarized below:   OECD 408 1) Rosin acids and resin acids, maleated, esters with pentaerythritol (CAS# 94581-17-6): The systemic toxicity NOAEL was determined to be 3000 ppm (equivalent to mean achieved dosages of 209.1 mg/Kg bw/day for males and 248.7 mg/Kg bw/day for females), based on histopathological changes apparent in both the liver and urinary bladder in animals exposed at the 6000 ppm and 12000/15000 ppm concentration levels.   2) Resin acids and Rosin acids, fumarated, esters with pentaerythitol (CAS# 94581-15-4): The NOAEL for systemic toxicity was considered to be 18000 ppm (equivalent to a mean achieved dosage of 1090.0 mg/Kg bw/day for males and 1298.9 mg/Kg bw/day for females), based on based on the lack of adverse treatment-related effects observed through the study period.   3) RARA, fumarated, esters with glycerol (CAS# 97489-11-7): The NOAEL for systemic toxicity was determined to be 18000 ppm for female rats (equivalent to mean achieved dosages of 1482.2 mg/Kg bw/day) and 7500 ppm (equivalent to mean achieved dosages of 574.0 mg/Kg bw/day) for male rats, based on treatment-related effects observed in male rats exposed at 18000 ppm. OECD 422   1) Resin acids and rosin acids, maleated, esters with pentaerythritol (CAS# 94581-17-6): The No Observed Adverse Effect Level (NOAEL) for systemic toxicity was considered to be 3000 ppm (equivalent to a mean achieved dosage of 179.3 mg/Kg bw/day in males and 221.5 mg/Kg bw/day in females), based on effects on body weight gain, food consumption and adverse histopathological changes in the kidney and urinary bladder at 7500 ppm and 18000/12000 ppm.   2) Resin acids and rosin acids, fumarated, esters with glycerol (CAS# 97489-11-7): The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was determined to be 7500 ppm for either sex (equivalent to a mean achieved dosage of 432.2 mg/Kg bw/day in males and 544.4 mg/Kg bw/day in females), based on microscopic lung changes in animals of either sex treated with 18000/15000 ppm, microscopic urinary bladder changes in females treated with 18000/15000 ppm and microscopic prostate changes in males treated with 18000 or 7500 ppm.   3) Resin acids and rosin acids, fumarated, esters with pentaerythritol (CAS# 94581-15-4): The No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was established to be 300 mg/Kg/day, based on evidence of limited systemic effects (microscopic changes in the urinary bladder) observed in animals in the 1000 mg/Kg bw/day dose group.   4) Rosin, fumarated (CAS# 65997-04-8): The No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was established to be 3000 ppm (equivalent to 221-288 mg/Kg bw/d in males, and 196-292 mg/Kg bw/d in females), based on decreased food consumption and mean body weights in parental animals of both sexes at 10,000 ppm and 3000 ppm, with high dose animals also showing an increase in total bilirubin (both sexes) and decreased adrenal weight (females only).   OECD 421   1) Resin acids and rosin acids, esters with pentaerythritol (CAS# 8050-26-8): The NOAEL was determined to be 20000 ppm (equivalent to received doses of 1864 mg/Kg bw/d in males and 1757 -2054 mg/Kg bw/d in females, respectively), based on lack of adverse treatment-related effects observed on reproductive performance or other parameters evaluated in the study.   2) Rosin (CAS# 8050-09-7): The NOAEL for systemic toxicity was considered to be 1000 ppm in males (equivalent to 84 mg/Kg bw/day) and 3000 ppm in females (equivalent to 309 mg/Kg bw/day), based on reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material.    OECD 414   1) Resin acids and rosin acids, fumarated esters with glycerol (CAS# 97489-11-7): The systemic toxicity NOAEL was determined to be 7500 ppm (equivalent to a mean achieved dosage of 622.2 mg/kg bw/day), based on lower maternal body weight gain during gestation and an initial effect on food consumption observed in animals treated at the 15000 ppm concentration level. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a121a566-8afc-4e57-8dbe-e93c3537d87a/documents/fcc799a7-5b21-4f57-b77f-c2dc21e15a83_0f17b580-e1c3-44f2-a1ff-8c62e0ef43d1.html,,,,,, "Rosin, fumarated, reaction products with glycerol and pentaerythritol",92202-14-7,Not acutely toxic following oral exposure or skin contact (LD50 >2000 mg/kg bw). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a121a566-8afc-4e57-8dbe-e93c3537d87a/documents/5c876f63-be0c-4753-897a-9aa6d18994a0_0f17b580-e1c3-44f2-a1ff-8c62e0ef43d1.html,,,,,, "Rosin, fumarated, reaction products with glycerol and pentaerythritol",92202-14-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a121a566-8afc-4e57-8dbe-e93c3537d87a/documents/5c876f63-be0c-4753-897a-9aa6d18994a0_0f17b580-e1c3-44f2-a1ff-8c62e0ef43d1.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Rosin, fumarated, reaction products with glycerol and pentaerythritol",92202-14-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a121a566-8afc-4e57-8dbe-e93c3537d87a/documents/5c876f63-be0c-4753-897a-9aa6d18994a0_0f17b580-e1c3-44f2-a1ff-8c62e0ef43d1.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Rosin, reaction products with formaldehyde",91081-53-7," Several key guideline (OECD 408, 414, 421, & 422 ) studies that investigated the repeated dose toxicity potential of Rosin; Rosin, hydrogenated; Rosin, oligomers; and Rosin, reaction products with formaldehyde following oral dietary exposure in rats are available. The results are summarized below: OECD 408 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL was determined to be 5000 ppm (equivalent to a mean achieved dosage of 335.2 mg/kg bw/day for males and 401.2 mg/kg bw/day for females) based on reduced body weight gains in animals of either sex exposed to 7500 ppm. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The NOAEL for systemic toxicity of Rosin, reaction products with formaldehyde was considered to be 3000 ppm (equivalent to mean achieved dosages of approximately 213.1 mg/kg bw/day or 255.2 mg/kg bw/day for males and females, respectively), based on the effects on body weight, body weight gain and, to a lesser extent, food consumption, observed among females exposed to diets containing 7500 ppm of the test material for ninety days. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): Based on a lack of adverse treatment-related effects observed at the highest concentration tested, the systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 6000 ppm for either sex (equivalent to a mean achieved dosage of 334.5 mg/kg bw/day for males and 399.8 mg/kg bw/day for females). OECD 414 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 2500 ppm (equivalent to a mean achieved dosage of 199.3 mg/kg bw/day) based on lower maternal body weight gain during gestation and an initial effect on food consumption at 7500 ppm and lower maternal body weight gain at 5000 ppm. OECD 421 1) Rosin (CAS# 8050 -09 -7): The systemic toxicity NOAEL for Rosin was determined to be 1000 ppm in males (equivalent to 84 mg/kg bw/d) and 3000 ppm in females (equivalent to 309 mg/kg bw/d) based upon reduced feed consumption and lower weight gain in animals consuming higher dietary concentrations of the test material. OECD 422 1) Rosin (CAS# 8050 -09 -7): In a key combined repeated dose, reproductive/developmental toxicity screening study (Harlan Laboratories Ltd, 2015a), the sytemic toxicity NOAEL for Tall oil rosin was determined to be 5000 ppm. In another key combined repeated dose, reproductive/developmental toxicity study (Harlan Laboratories Ltd., 2014a), the systemic toxicity NOAEL for Gum Rosin was determined to be 2500 ppm. A NOEL (No Observed Effect Level) for general toxicity could not be established due to effects on body weights at all dose levels in females during the lactation period. 2) Rosin, reaction products with formaldehyde (CAS# 91081 -53 -7): The systemic toxicity NOAEL for Rosin, reaction product with formaldehyde was determined to be 10000 ppm and the NOEL was established at a concentration of 1000 ppm. 3) Rosin, hydrogenated (CAS# 65997 -06 -0): The systemic toxicity NOAEL for Rosin, hydrogenated was determined to be 3000 ppm. Based on the histopathological changes observed in adrenal glands, no NOEL for systemic toxicity was established for females whereas for males it was at the dose level of 1000 ppm. 4) Rosin, oligomers: The systemic toxicity NOAEL for Rosin, oligomers in male rats was determined to be 7500 ppm, based on statistically significant body weight and body weight gain effects observed at the 15000 ppm concentration level. The systemic toxicity NOAEL for female rats was determined to be 3000 ppm, based on effects on body weight and body weight gain in females exposed to the test material at 7500 and 15000 ppm. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c250d56f-1908-4e72-b52c-191727ef67ad/documents/52e343f0-7863-43da-bdf3-2d1dead326d6_f167a42a-356b-4fb9-b8b6-69053208a7d0.html,,,,,, "Rosin, reaction products with formaldehyde",91081-53-7,Not acutely toxic following oral or dermal exposure (LD50 >2000 mg/kg bw in both instances). Low vapour pressure precludes inhalation exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c250d56f-1908-4e72-b52c-191727ef67ad/documents/26ea1820-f505-474a-bbe6-85a0477186a6_f167a42a-356b-4fb9-b8b6-69053208a7d0.html,,,,,, "Rosin, reaction products with formaldehyde",91081-53-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c250d56f-1908-4e72-b52c-191727ef67ad/documents/26ea1820-f505-474a-bbe6-85a0477186a6_f167a42a-356b-4fb9-b8b6-69053208a7d0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Rosin, reaction products with formaldehyde",91081-53-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c250d56f-1908-4e72-b52c-191727ef67ad/documents/26ea1820-f505-474a-bbe6-85a0477186a6_f167a42a-356b-4fb9-b8b6-69053208a7d0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Rubidium nitrate,13126-12-0," For oral acute toxicity endpoint, studies coming from the public domain have been used to fulfil the requirement. - Khamidulina (1987 - Russian paper) is reporting a LD50 for rubidium nitrate of 4625 mg/kg bw. Khamidulina (1987) is also reporting the following values for other rubidium salts, these values are: - Rubidium carbonate (CAS 584 -09 -8) - LD50 (oral, rat) 2625 mg/kg - Rubidium chloride (CAS 7791 -11 -9) - LD50 (oral, rat) 5000 mg/kg - Rubidium hydroxide (CAS 1310 -82 -3) - LD50 (oral, rat) 1650 mg/kg* !! alkaline effect!! - Rubidium sulfate (CAS 7488 -54 -2) - LD50 (oral, rat) 4594 mg/kg As weight of evidence with Rubidium salts, other values have been reported. - Johnson et al. (1975) has reported an acute oral LD50 for Rubidium iodide in albino rats of 4708 mg/kg bw. another publication prepared by FS Wagner 2011 (Encyclopedia) has also reported values for different rubidium salts: - Rubidium carbonate (CAS 584 -09 -8) - LD50 (oral, rat) 2625 mg/kg - Rubidium chloride (CAS 7791 -11 -9) - LD50 (oral, rat) 4040 mg/kg - Rubidium hydroxide (CAS 1310 -82 -3) - LD50 (oral, rat) 586 mg/kg* !! alkaline effect!! - Rubidium iodide (CAS 7790 -29 -6) - LD50 (oral, rat) 4708 mg/kg - Rubidium sulfate (CAS 7488 -54 -2) - LD50 (oral, rat) 4594 mg/kg According the data found in the literature, we can conclude that rubidium salts including rubidium nitrate is considered as NOT toxic regarding acute oral toxicity. It has to be noted that the LD50 oral acute on rats made with rubidium hydroxide has been disregarded as the adverse effects is induced by the hydroxide. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cdb86b3c-680e-433d-84a6-c48379a56392/documents/15287416-8fec-4aa1-b67e-b7933993bb2f_b1d4b427-4faf-470e-b29b-0a5ce29e907c.html,,,,,, Rubidium nitrate,13126-12-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cdb86b3c-680e-433d-84a6-c48379a56392/documents/15287416-8fec-4aa1-b67e-b7933993bb2f_b1d4b427-4faf-470e-b29b-0a5ce29e907c.html,,oral,LD50,"4,625 mg/kg bw",no adverse effect observed, Ruthenium,7440-18-8, No relevant repeated dose toxicity data were identified. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1df9b0f-278e-4356-a4e3-c1b62fbd1b42/documents/7f3d84b1-0dea-416c-804e-b0d9a3d111a2_37ee4604-e607-436f-9b9c-3aa6886a18ed.html,,,,,, Ruthenium,7440-18-8," No relevant acute oral, dermal or inhalation toxicity data were identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1df9b0f-278e-4356-a4e3-c1b62fbd1b42/documents/73ac3e09-04c2-41a3-b3b7-82cf098959dd_37ee4604-e607-436f-9b9c-3aa6886a18ed.html,,,,,, Ruthenium (IV) oxide,12036-10-1,"The acute oral LD50 of ruthenium (IV) oxide hydrate in rats was found to be greater than 2000 mg/kg bw (Collier, 1982a). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8918bd14-8336-413d-8165-b725e27348cf/documents/IUC5-7accd860-25bb-462c-895c-f5a28f003d5b_88528365-85f0-4f85-b1b2-9182e3311ea8.html,,,,,, Ruthenium (IV) oxide,12036-10-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8918bd14-8336-413d-8165-b725e27348cf/documents/IUC5-7accd860-25bb-462c-895c-f5a28f003d5b_88528365-85f0-4f85-b1b2-9182e3311ea8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ruthenium trichloride hydrate,14898-67-0," In an OECD Test Guideline 407 repeated dose oral toxicity study, rats were fed diets containing 0, 500, 1500, 5000 or 15,000 ppm ruthenium trichloride hydrate for 28 days. Males in the highest dose group had reduced body weight gain and reduced food conversion efficiency compared to controls. There were no other adverse effects in these animals, and no effects on clinical signs, pathology, organ weights or histopathology in any treated animals. The study NOAEL was 5000 ppm (equivalent to about 407 mg/kg bw/day) (Zelenák, 2017).   No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45b02312-dc5b-4bdf-b745-667021f19773/documents/d60a6efb-a2bd-4429-bc11-e81977f2a49f_8a3fe5ae-a929-48eb-a6bc-66b70eb9a1b0.html,,,,,, Ruthenium trichloride hydrate,14898-67-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/45b02312-dc5b-4bdf-b745-667021f19773/documents/d60a6efb-a2bd-4429-bc11-e81977f2a49f_8a3fe5ae-a929-48eb-a6bc-66b70eb9a1b0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,407 mg/kg bw/day,,rat Ruthenium trichloride hydrate,14898-67-0," In an OECD guideline study, the acute oral LD50 value for ruthenium trichloride hydrate was determined to be 595 mg/kg bw in rats (Berthold, 1993).   No relevant acute dermal or inhalation toxicity data were identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45b02312-dc5b-4bdf-b745-667021f19773/documents/2fc09538-be47-438a-908a-e3a2fc5a23d6_8a3fe5ae-a929-48eb-a6bc-66b70eb9a1b0.html,,,,,, Ruthenium trichloride hydrate,14898-67-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/45b02312-dc5b-4bdf-b745-667021f19773/documents/2fc09538-be47-438a-908a-e3a2fc5a23d6_8a3fe5ae-a929-48eb-a6bc-66b70eb9a1b0.html,,oral,LD50,595 mg/kg bw,adverse effect observed, "[1,3-bis(2,4,6-trimethylphenyl)-4,5-dimethylimidazol-2-ylidene](2-thienylmethylidene)(tricyclohexylphosphine)ruthenium(II)dichloride]",1190427-50-9, The test substance was tested for acute oral toxicity according to OECD TG 423 and under GLP. A single oral application of the test item to rats at a dose of 2000 mg/kg body weight was not associated with any signs of toxicity or mortality during an observation period of 14 days. The LD50 cut-off (rat) was therefore determined to amount 5000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02b070e8-9c39-4fa4-b743-053537d1b8f5/documents/3b50e6d6-e981-4258-83bd-e8b9825f20af_5c1f9a33-64d5-4326-8f60-f267a2773e45.html,,,,,, "Saccharomyces cerevisiae, lysate",94350-12-6,"No information via the dermal and inhalation routes is available.A subacute repeated dose toxicity study via the oral route is available for Saccharomyces cerevisiae, lysate (Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test). Based on the results of this key study (Hargitai, Klimisch 1, 2018, GLP, OECD TG 422), the No Observed Adverse Effect Level (NOAEL) for the test item Saccharomyces Cerevisiae, lysate was defined to be 1000 mg/kg bw/day for rats, through oral route. In order to meet the standard information requirements of Regulation (EC) 1907/2006, Annex IX, Column 1, 8.6.2, a reliable subchronic toxicity study should be submitted for Saccharomyces cerevisiae, lysate. No subchronic or chronic repeated dose toxicity study via the oral route is specifically available for Saccharomyces Cerevisiae, lysate substance. However, several reliable studies ranging from subacute to chronic durations are available for either live and dead Saccharomyces Cerevisiae (SC) yeast or various SC-derived substances. Therefore, an overall weight of evidence is used to fulfil the standard information requirements of Regulation (EC) 1907/2006 for this endpoint. Saccharomyces cerevisiae, lysate is the concentrated, non-extracted, partially soluble digest obtained from yeast biomass produced according to common yeast fermentation process. The lysis of yeast cells results in both soluble and insoluble components (cell walls). Saccharomyces cerevisiae, lysate can therefore reasonably be considered as a combination of the two SC derivative substances Saccharomyces cerevisiae, ext. (SC Yeast extract EC # 283-294-5) and Saccharomyces cerevisiae cell wall, extracted (SC cell walls; EC 949-711-6). Oral (gavage) subchronic studies (GLP compliant) in the rat are available for both SC yeast extract and SC cell walls (Krapivin, Klimisch 2, 2020, GLP, Russian guideline). Both tests were performed as a mandatory requirement for the registration of the substances as feed additives on the territory of the Russian Federation. Female rats were daily treated for 90 days with doses of 0, 1000 and 2000 mg/kg bw/day for Saccharomyces cerevisiae, ext. and doses of 0, 500 and 1000 mg/kg bw/day for Saccharomyces cerevisiae cell wall, extracted. Parameters evaluated were general condition and behaviour, functional state of the central nervous system, manifestation of toxicity symptoms, signs of morbidity and mortality, body weight, blood counts [Haematocrit (%), Haemoglobin (g/l), Erythrocytes (number/L), Leucocytes (number/L), Platelets (number/L), Leukogram], clinical biochemistry [Bilirubin, Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Urea, Creatinine, Total protein, Alkaline phosphatase, Glucose], macroscopic examination of internal organs (liver, lungs, kidneys, heart, spleen, stomach, intestine) and mass ratios internal organs (liver, kidneys, spleen, lungs and heart). Although the method followed was not compliant with the current EU OECD TG 408, the results from the two studies did not reveal significant treatment related toxicological effects up to the highest concentrations tested and the derived subchronic NOAEL for both substances was the maximum dose level recommended by the OECD TG 408 (i.e., 1000 mg/kg bw/day). Taken together the results of the subacute study on the target substance and the results of the subchronic studies on SC yeast extract and SC cell walls, it not expected that Saccharomyces cerevisiae, lysate would show any toxicity upon subchronic repeated exposure. Other Saccharomyces cerevisiae derivatives were also tested for oral repeated dose toxicity. The yeast hydrolysate from Saccharomyces cerevisiae (Protein hydrolyzates, yeast; EC # 309-709-2) was evaluated for subacute (14 days) toxicity in the rat (male and female) at the limit dose of 1000 mg/kg bw/day (Jung, Klimisch 2, 2010, GLP not specified, OECD TG 407). The results of this study showed that the yeast hydrolysate from SC did not induce toxicity upon a subacute repeated exposure to the limit dose of 1000 mg/kg bw/day in male and female rats and the subacute oral NOAEL was considered to be ≥ 1000 mg/kg bw/day. Yeast hydrolysate from SC (Protein hydrolyzates, yeast; EC # 309-709-2) was also tested for oral subchronic toxicity in the rat (male and female) (Yejin, Klimisch 2, 2021, GLP not specified, OECD TG 408). The substance was administered to rats at a limit dose level of 1000 mg/kg for 90 days. Results of this study showed the SC yeast hydrolysate to be safe and non-toxic following subchronic repeated administration of 1000 mg/kg bw/day.A dried fermentate preparation of Saccharomyces cerevisiae was orally tested for both subchronic and chronic repeated dose toxicity in the rat (male and female) (Schauss, Klimisch 2, 2012, GLP, OECD TG 408 and 452). The tested doses were 0, 30, 200, and 1500 mg/kg bw/day for the subchronic study and 0, 20, 200, and 800 mg/kg bw/day for the chronic study. Results from both studies showed that the dried fermentate preparation of Saccharomyces cerevisiae was well tolerated up to the highest doses tested of 1500 mg/kg bw/day and 800 mg/kg bw/day and the subchronic and chronic NOAEL were 1500 mg/kg bw/day and 800 mg/kg bw/day respectively. Repeated dose toxicity of the Saccharomyces cerevisiae yeast itself, as live or dead whole organism, was also assessed via the oral route. The subchronic (60 day-study) toxicity of live S. cerevisiae suspension was assessed in male rats to acquire data on the safety-in-use of the probiotic Saccharomyces cerevisiae strain RC016 (Gonzalez Pereyra, Klimisch 2, 2014, GLP not specified, non-guideline test). The results of this study demonstrated that oral daily administration of the probiotic Saccharomyces cerevisiae strain RC016 in male rats for 60 days did not result in any illness, mortality or any other treatment-related health changes. No negative impact on the animals’ weight gain, Feed Conversion or Feed Efficiency was found and no macroscopic or microscopic differences or lesions was observed, which suggested the strain to be safe to use in vivo. Subchronic repeated dose toxicity of a fractionated Saccharomyces cerevisiae biomass as a single source of dietary protein was evaluated in male rats (Caballero-Cordoba, Klimisch 2, 2000, GLP not specified, non-guideline test). Animals were fed diets with 15 and 30% protein from the fractionated yeast biomass during 45 and 90 days. The results of this study showed no evidence of toxicity for the whole Saccharomyces cerevisiae yeast biomass after 45 and 90 days of feeding. No mortality, no evidence of toxicity and no effects on body weights or food consumption. Furthermore, no toxicologically relevant effect was noted based on the blood chemistry, urinalysis and organ analysis results.Furthermore, the Expert Panel for Cosmetic Ingredient Safety recently reviewed the safety of Saccharomyces cerevisiae yeast-derived ingredients (CIR, 2021). Among assessed Saccharomyces cerevisiae (SC) yeast derived substances, a SC beta-glucan extract was tested for oral subchronic repeated dose toxicity [Babicek et al. 2007; GLP, OECD TG 408 (1998)] in male and female rats. Rats (10/sex/group) were given either 2, 33.3, or 100 mg/kg bw/d of the test item in water, via gavage, once a day, for 91 d. A control group was given water only. No mortality, clinical pathology, functional/behavioral, microscopic, or gross observations indicating toxicity were observed. In addition, no negative effects on animal weights or food consumption were noted. No dose-dependent hematological or biochemical toxicities were observed. A no-observed-adverse-effect level (NOAEL) of 100 mg/kg bw/d was established based on the results of this study. Taking into account all the reliable repeated dose toxicity data available on the target substance Saccharomyces cerevisiae, lysate as well as on the various Saccharomyces cerevisiae derivative substances or the whole SC yeast organism (ranging from subacute to chronic), it can be concluded on a weight of evidence basis that no toxicity upon repeated exposure is expected for the registered substance Saccharomyces cerevisiae, lysate and no additional testing is considered necessary. In the absence of adverse effects, no STOT-RE classification is required for Saccharomyces cerevisiae, lysate substance according to CLP criteria. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Reliability 1 and 2 studies relevant for assessment. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad3c98ca-9777-4864-99a3-03e94fbb049f/documents/235da198-0d1b-45eb-8235-b6f01df5bcf8_6d22c39b-d37e-414a-bfde-9cdd14950d6d.html,,,,,, "Saccharomyces cerevisiae, lysate",94350-12-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad3c98ca-9777-4864-99a3-03e94fbb049f/documents/235da198-0d1b-45eb-8235-b6f01df5bcf8_6d22c39b-d37e-414a-bfde-9cdd14950d6d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Saccharomyces cerevisiae, lysate",94350-12-6," Based on the two available key studies (Appl, OECD TG 423 and 402, Klimisch 1, 2017), the test substance was not classified for acute oral and dermal hazard according to CLP criteria. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad3c98ca-9777-4864-99a3-03e94fbb049f/documents/696caec7-11bb-44ca-bf88-b19a5c89e163_6d22c39b-d37e-414a-bfde-9cdd14950d6d.html,,,,,, "Saccharomyces cerevisiae, lysate",94350-12-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad3c98ca-9777-4864-99a3-03e94fbb049f/documents/696caec7-11bb-44ca-bf88-b19a5c89e163_6d22c39b-d37e-414a-bfde-9cdd14950d6d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Saccharomyces cerevisiae, lysate",94350-12-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad3c98ca-9777-4864-99a3-03e94fbb049f/documents/696caec7-11bb-44ca-bf88-b19a5c89e163_6d22c39b-d37e-414a-bfde-9cdd14950d6d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Salicylonitrile,611-20-1,"Oral: LD50=500 mg/kg bw, female, rat, OECD 423, Wolf 2008 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/911dcba8-97f6-41f0-831a-1c2272e26ea6/documents/b914b34d-0dff-41a3-9f6d-1953e23ab039_9899b970-313b-40d9-963c-b2985e74b961.html,,,,,, Salicylonitrile,611-20-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/911dcba8-97f6-41f0-831a-1c2272e26ea6/documents/b914b34d-0dff-41a3-9f6d-1953e23ab039_9899b970-313b-40d9-963c-b2985e74b961.html,,oral,LD50,500 mg/kg bw,adverse effect observed, S-allyl O-pentyl dithiocarbonate,2956-12-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3399126-1314-43b6-8a10-1450f31658e9/documents/7e027b5d-41c1-4d99-a689-a1941fee8ec1_331e9251-80d3-44a6-b763-417126ab2725.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,100 mg/m3,,dog S-allyl O-pentyl dithiocarbonate,2956-12-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d3399126-1314-43b6-8a10-1450f31658e9/documents/7e027b5d-41c1-4d99-a689-a1941fee8ec1_331e9251-80d3-44a6-b763-417126ab2725.html,Chronic toxicity – systemic effects,oral,LOAEL,10 mg/kg bw/day,,rat S-allyl O-pentyl dithiocarbonate,2956-12-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3399126-1314-43b6-8a10-1450f31658e9/documents/75b50345-b40e-441c-934b-553273ce61d7_331e9251-80d3-44a6-b763-417126ab2725.html,,oral,LD50,590 mg/kg bw,adverse effect observed, S-allyl O-pentyl dithiocarbonate,2956-12-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3399126-1314-43b6-8a10-1450f31658e9/documents/75b50345-b40e-441c-934b-553273ce61d7_331e9251-80d3-44a6-b763-417126ab2725.html,,inhalation,LC50,"7,690 mg/m3",adverse effect observed, Samarium,7440-19-9," In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable. It is not considered appropriate to test an extract following dissolution of the massive form in aqueous media as the substance is highly insoluble meaning there would be an insufficient concentration of dissolved metal ions in the extract solution to be tested. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b825d96-6c91-4f40-aab0-3b1dd95d2e43/documents/c001d14e-e52f-4ce4-aeb2-4bbb62f8111d_c469a1ae-2a40-4bee-84fe-813f83175c99.html,,,,,, Samarium,7440-19-9," Acute Oral Toxicity In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable. It is not considered appropriate to test an extract following dissolution of the massive form in aqueous media as the substance is highly insoluble meaning there would be an insufficient concentration of dissolved metal ions in the extract solution to be tested. - Supporting information on the read-across substance, samarium oxide - 1990 Study: Under the conditions of the study the acute oral LD50 to male and female Sprague dawley rats was determined to be in excess of 5 000 mg/kg. - 1963 Study: Under the conditions of the study the acute oral LD50 to female rats was determined to be in excess of 1 000 mg/kg. Since the surface of samarium metal oxidises on contact with air to form an outer layer of samarium oxide, it is considered appropriate to read across information from samarium oxide to the metal where testing on the metal is not technically possible. Acute Inhalation Toxicity In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable. It is not possible to generate an atmosphere of test material that would be suitable for testing. The smallest size of substance that can be generated without the risk of fire would be too dense to produce a test atmosphere for testing. Furthermore, exposure of humans via inhalation will not occur as the substance is not used in powdered form and the powdered form of the substance will not be generated during substance use. Acute Dermal Toxicity In accordance with Section 2 of REACH Annex XI, this study does not need to be conducted as testing is not technically possible. It is not possible to produce a powdered form of the substance suitable for testing as the powdered form is flammable. It is not considered appropriate to test an extract following dissolution of the massive form in aqueous media as the substance is highly insoluble meaning there would be an insufficient concentration of dissolved metal ions in the extract solution to be tested. As the substance is highly insoluble, the study is also omitted on grounds there would be no potential for a significant rate of absorption through the skin. Furthermmore, information from an acute oral toxicity study conducted with the read across substance, samarium oxide, suggests the substance does not meet the criteria for classification as acute toxicity or STOT SE (acute oral LD50 > 5 000 mg/kg). Since the surface of samarium metal oxidises on contact with air to form an outer layer of samarium oxide. It is therefore considered appropriate to read across information from samarium oxide to the metal where testing on the metal is not technically possible. - Supporting information on the read-across substance, samarium oxide Under the conditions of the study, the acute dermal LD50 to male and female Sprague Dawley rats was determined to be in excess of 2 000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b825d96-6c91-4f40-aab0-3b1dd95d2e43/documents/8dfae127-9902-4430-a132-6bbc33db405f_c469a1ae-2a40-4bee-84fe-813f83175c99.html,,,,,, Samarium,7440-19-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b825d96-6c91-4f40-aab0-3b1dd95d2e43/documents/8dfae127-9902-4430-a132-6bbc33db405f_c469a1ae-2a40-4bee-84fe-813f83175c99.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Samarium,7440-19-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b825d96-6c91-4f40-aab0-3b1dd95d2e43/documents/8dfae127-9902-4430-a132-6bbc33db405f_c469a1ae-2a40-4bee-84fe-813f83175c99.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Samarium (III) chloride hexahydrate,10361-82-7,Samarium chloride at all concentrations up to 1% used in the diet produced no histopathological changes in any of the organs studied. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/05af2990-4480-4d51-a16a-b0aac0d1ff1c/documents/IUC5-7f5fa6a6-7ad5-4cf8-a1ab-b09d1e12c151_4c9bdd33-1271-48c2-b984-4d6be5acbc88.html,,,,,, Samarium (III) chloride hexahydrate,10361-82-7,"No studies about Samarium chloride were available, but studies about analogue compounds:oral: LD50 (rat) = 2900 mg / kg bw Samarium nitrate (analogue substance)oral: LD50 (rat) = 2621 mg/kg bw Lanthanum chloride, anhydrous (original value: 3200 mg/kg bw Lanthanum chloride trihydrate) (analogue substance)dermal: LD50 (rabbit) > 1638 mg/kg bw Lanthanum chloride, anhydrous ((original value: > 2000 mg/kg bw Lanthanum chloride trihydrate) (analogue substance) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05af2990-4480-4d51-a16a-b0aac0d1ff1c/documents/IUC5-04d2e287-9d1d-4821-b644-3f82ef15a103_4c9bdd33-1271-48c2-b984-4d6be5acbc88.html,,,,,, "benzyl butyl cis-cyclohexane-1,2-dicarboxylate",1931129-39-3, Rat oral NOAEL: 1000 mg/Kg/day (OECD 408) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/230a7887-8e49-473c-9cfc-36b1117e4a11/documents/e47e43ed-c0b7-43b5-ae25-29ad3187402c_475eebbb-ed88-427c-99ea-ab9183fc3f69.html,,,,,, "benzyl butyl cis-cyclohexane-1,2-dicarboxylate",1931129-39-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/230a7887-8e49-473c-9cfc-36b1117e4a11/documents/e47e43ed-c0b7-43b5-ae25-29ad3187402c_475eebbb-ed88-427c-99ea-ab9183fc3f69.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "benzyl butyl cis-cyclohexane-1,2-dicarboxylate",1931129-39-3," ACUTE ORAL The potential for oral acute toxicity of the test material Santicizer Platinum P1400 was determined according the OECD 423 and OPPTT 870.1000 Testing Guidelines. Three males and three females Sprague Dawley were dosed orally with 2000 mg/kg of Santicizer Platinum P1400. The single dose was based on the sample weight as calculated from the specific gravity. A single dose was administered orally by syringe and dosing needle. The animals were observed for mortality, body weight changes, general toxicity and pharmacological effects. All animals survived until the end of the treatment. No abnormal physical signs nor changes in body weights related to the treatment were observed. The gross pathology were normal. Based on the results of this study, the LD50 was considered to be greater than 2000 mg/kg bw. ACUTE DERMAL The test article Santicizer Platinum P1400 was applied dermally to five male and female rabbits. The test material was kept in contact with the scin for 24 hours (semi- occlusive patch). The test sites were scored for dermal irritation at 24 hours post dose and on day 14 using numerical Draize scoring code below. The skin was evaluated for ulceration, necrosis and tissue destruction. Mortality, body weights, toxicit, pharmacologic effects were recorded. The results of the study showed incidence of few faces in two males and one female with soiling of the angemital area on day 14. Erythema was slight to well denined with very slight to sligh edema at 24 hours and by day 14 no erytthema was observed. The body weights were normal as well as the necropsy results. Based on the result of this study, the acute dermal toxicity LD50 of the test material Santicizer Platinum P 1400 is greater than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/230a7887-8e49-473c-9cfc-36b1117e4a11/documents/bef5a311-8118-4149-b3a8-e554f9deee78_475eebbb-ed88-427c-99ea-ab9183fc3f69.html,,,,,, "benzyl butyl cis-cyclohexane-1,2-dicarboxylate",1931129-39-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/230a7887-8e49-473c-9cfc-36b1117e4a11/documents/bef5a311-8118-4149-b3a8-e554f9deee78_475eebbb-ed88-427c-99ea-ab9183fc3f69.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "benzyl butyl cis-cyclohexane-1,2-dicarboxylate",1931129-39-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/230a7887-8e49-473c-9cfc-36b1117e4a11/documents/bef5a311-8118-4149-b3a8-e554f9deee78_475eebbb-ed88-427c-99ea-ab9183fc3f69.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Scale (coating), copper",69012-45-9,- complex metal containing substance- solubility of metal constituents is poor- classification via mixture toxicity rules ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb11fa96-2868-4298-9e80-33a6b3a2a439/documents/IUC5-34d07c67-92fe-465c-87c2-c15b24b9d83f_4a65e16e-562e-4c09-8b2d-47cf4659eec7.html,,,,,, "Scale (coating), copper",69012-45-9,- complex metal containing substance- water solubility of the substance is poor (for metal constituents)- classification based on mixture toxicity rules ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb11fa96-2868-4298-9e80-33a6b3a2a439/documents/IUC5-6948adbb-660b-4d88-9235-3b82fe8441ed_4a65e16e-562e-4c09-8b2d-47cf4659eec7.html,,,,,, "Schiff bases, C11-14-tert-alkyl methylene",68607-67-0," On the basis of this 28-Day Repeated Dose Oral Toxicity study with formaldehyde, reaction products with ethylenediamine in male and female Wistar rats with dose levels of 100, 300, and 800 mg/kg body weight day, the following conclusions can be made: At 800 mg/kg BW increased clinical symptoms were found which indicate discomfort of the animals. Furthermore, decreased thymus weight as well as increased adrenal weight indicates stress of the animals, too. An additional tissue besides the stomach occurred probably due to the local irritant effect of the test item. Pathologically, test item-related lesions of toxicological significance were seen in the kidney and comprised mild or moderate tubular degeneration/regeneration at the inner cortex in all rats treated at 800 mg/kg/day. Hence, the dosage of 800 mg/kg BW is assumed to induce adverse effects within this study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb491f24-1d84-457a-9081-06e5f6f442fd/documents/569793af-fbe7-4865-89c9-4f07f5a5d392_5fd71622-a47c-466f-bd61-34d99078789a.html,,,,,, "Schiff bases, C11-14-tert-alkyl methylene",68607-67-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eb491f24-1d84-457a-9081-06e5f6f442fd/documents/569793af-fbe7-4865-89c9-4f07f5a5d392_5fd71622-a47c-466f-bd61-34d99078789a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Schiff bases, C11-14-tert-alkyl methylene",68607-67-0," Acute toxicity studies with rats are available for the oral, dermal and inhalation routes of exposure. The ATE is 500 mg/kg oral and > 2,000 mg/kg bw for the dermal route. The LC50 for the inhalation route is in the range between 1.04 - 5.12 mg/L. Oral exposure appears to lead to more significant toxicity than exposure by dermal or inhalation routes. In view of the oral toxicity seen in similar substances, no further animal testing can be justified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb491f24-1d84-457a-9081-06e5f6f442fd/documents/c0a62071-8fe2-4d2e-9383-c3489bee3d13_5fd71622-a47c-466f-bd61-34d99078789a.html,,,,,, "Schiff bases, C11-14-tert-alkyl methylene",68607-67-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb491f24-1d84-457a-9081-06e5f6f442fd/documents/c0a62071-8fe2-4d2e-9383-c3489bee3d13_5fd71622-a47c-466f-bd61-34d99078789a.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, "Schiff bases, C11-14-tert-alkyl methylene",68607-67-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb491f24-1d84-457a-9081-06e5f6f442fd/documents/c0a62071-8fe2-4d2e-9383-c3489bee3d13_5fd71622-a47c-466f-bd61-34d99078789a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sebacic acid, compound with hexane-1,6-diamine (1:1)",6422-99-7,LD50 oral: 4900 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/949bbed3-e251-4fdc-b736-23dd6c140831/documents/IUC5-e663673c-ea30-417e-a6d1-df9deef532c9_d6cd9559-0147-42f7-b1e6-b0a2af581faa.html,,,,,, "Sebacic acid, compound with hexane-1,6-diamine (1:1)",6422-99-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/949bbed3-e251-4fdc-b736-23dd6c140831/documents/IUC5-e663673c-ea30-417e-a6d1-df9deef532c9_d6cd9559-0147-42f7-b1e6-b0a2af581faa.html,,oral,LD50,"4,900 mg/kg bw",no adverse effect observed, sec-butyl chloroformate,17462-58-7,"BASF, 1984 The acute LD50(oral) of sec.-Butylchloroformate in rats is determined to be: 1000 - 1780 mg/kg. According to the results of the present study the test substance, sec-Butylchlorformate has to be regarded as harmful after single oral application. The study is conducted similar to OECD 401 and is reliable without restrictions. Male and female Wistar rats were treated with 562, 1000 or 1780 mg/kg test substance by gavage. No mortality was observed in doses up to 1000 mg/kg. The acute LD50 of sec.-Butylchloroformate in rats lies between 1000 - 1780 mg/kg after oral application. Haemorrhagic gastritis in glandular stomach was found in animals found dead and thickened gastric wall of the forestomach in sacrificed animals at necropsy. Due to the reporting of the experimental details, the study was rated with Klimisch score 1 (reliable without restriction) and is therefore used for the key value. BASF, 1970 The acute LD50(oral) of sec.-Butylchloroformate in rats is determined to be: 1000 mg/kg. According to the results of the present study the test substance, sec-Butylchlorformate has to be regarded as harmful after single orall application. The study is comparable to OECD 401 with acceptable restrictions mostly due to reduced reporting in times before GLP. Application volume was too high in the highest does group. This dose group is invalid. However, this is not relevant for the result of the study and therefore not relevant for the overall reliability of this study. Groups of 10 rats per sex and dose were administered 800, 1000, 1250, 1600, 3200 and 6400 mg/kg of the test substance per gavage. No mortality was observed in the 800 mg/kg dose group. The acute LD50 of sec-Butylchlorformate in rats is ca. 1000 mg/kg after oral application. Squatting posture, irregular breathing and aqueous discharge from the oral cavity was observed as reversible clinical signs. There were no substance related findings in the sacrificed animals noted. Bloody erosion in the glandular stomach and gastroenterorrhagie, bloody discoloration of the stomach and stomach with distinct vascular injections were observed for the animals found dead after administration of the test substance. Due to the reporting of the experimental details, the study was rated with Klimisch score 2 (reliable with restriction). Based on the data obtained the test item has to be regarded as harmful after single oral application (according to GHS criteria). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1cbb662d-3081-4996-a547-881776c5d9c3/documents/674a90c6-0c3f-4215-a953-93fc8f2b6282_13d170a9-e0e1-4b3d-b29d-965c9dd465de.html,,,,,, sec-butyl chloroformate,17462-58-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1cbb662d-3081-4996-a547-881776c5d9c3/documents/674a90c6-0c3f-4215-a953-93fc8f2b6282_13d170a9-e0e1-4b3d-b29d-965c9dd465de.html,,oral,LD50,"1,527 mg/kg bw",adverse effect observed, Sedolisin,848318-58-1,"Based on the results of the study it was concluded that the No Observed Adverse Effect Level (NOAEL) of the test item Sedolisin, batch PPF38268 was found to be the high dose group of 5 mL/kg body weight/day of 100% v/v, corresponding to 656 mg enzyme concentrate dry matter/kg body weight/day when administered for a period of 14 consecutive days by oral (gavage) route to Sprague Dawley rats under the experimental conditions and the doses employed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2866834b-a6b1-46f4-b721-8f3242309874/documents/33709bc5-e423-4b93-bc6c-4fdecb308e41_60d8bcf5-a2d2-4b33-bacc-d402294b5366.html,,,,,, Sedolisin,848318-58-1,"The study does not need to be conducted because a 14-day repeated dose toxicity study in rats was available. The 14-day repeated dose toxicity study revealed that the No Observed Adverse Effect Level (NOAEL) of the test item Sedolisin batch PPF38268 was found to be high dose group of 5 mL/kg body weight/day of 100% v/v, corresponding to 656 mg Enzyme concentrate dry matter/kg body weight/kg body weight/day when administered for a period of 14 consecutive days by oral (gavage) route to Sprague Dawley rats under the experimental conditions and the doses employed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2866834b-a6b1-46f4-b721-8f3242309874/documents/cac0de3a-1642-4a4a-9428-892a1b1da4a5_60d8bcf5-a2d2-4b33-bacc-d402294b5366.html,,,,,, Selenium dioxide,7446-08-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Literature data of good quality (Klimisch 2). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Read-across from GLP study of hight quality (Klimisch 1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d68b3825-29d5-4b1d-93b5-3ee7a202fada/documents/62255b38-d73b-440a-8985-7298c42aaa28_cb27374e-2255-40a8-85db-6aae1813d02b.html,,,,,, Selenium dioxide,7446-08-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d68b3825-29d5-4b1d-93b5-3ee7a202fada/documents/62255b38-d73b-440a-8985-7298c42aaa28_cb27374e-2255-40a8-85db-6aae1813d02b.html,,oral,LD50,7 mg/kg bw,adverse effect observed, Selenium dioxide,7446-08-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d68b3825-29d5-4b1d-93b5-3ee7a202fada/documents/62255b38-d73b-440a-8985-7298c42aaa28_cb27374e-2255-40a8-85db-6aae1813d02b.html,,inhalation,LC50,0.052 mg/m3,adverse effect observed, Semicarbazide hydrochloride,563-41-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8349b704-417b-4db9-8e07-b170b6a0a672/documents/cdc5e1eb-8d89-45db-b7d3-4253fb1693c5_4c57d0fd-0ec8-4d55-befe-9ec617833d23.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,18.1 mg/kg bw/day,,rat Semicarbazide hydrochloride,563-41-7," A draft paper from 1982 and a book from 1958 have been used to cover this endpoint as no other data are available. Different species and routes have been used, but studies are not available. A Testing proposal should be performed on the basis of Klimisch 4 scoring of the data, different species used and possibly different routes of administration in the reported study. All data demonstrated LD50 in the average of 100 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8349b704-417b-4db9-8e07-b170b6a0a672/documents/5d107628-851c-4763-b482-35944c0e5d5f_4c57d0fd-0ec8-4d55-befe-9ec617833d23.html,,,,,, Semicarbazide hydrochloride,563-41-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8349b704-417b-4db9-8e07-b170b6a0a672/documents/5d107628-851c-4763-b482-35944c0e5d5f_4c57d0fd-0ec8-4d55-befe-9ec617833d23.html,,oral,LD50,100 mg/kg bw,adverse effect observed, Semicarbazide hydrochloride,563-41-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8349b704-417b-4db9-8e07-b170b6a0a672/documents/5d107628-851c-4763-b482-35944c0e5d5f_4c57d0fd-0ec8-4d55-befe-9ec617833d23.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, S-ethyl N-cyclohexylthiocarbamate,1134-23-2,"Migrated Data from field(s)Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable very well documented ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91a745ed-b6b9-422b-aebe-bb7341bfd04d/documents/3b1e4d6f-ae02-4a5e-b376-c3c78cbd3f7a_0e93746e-ba24-44ca-9054-2d70e823367d.html,,,,,, S-ethyl N-cyclohexylthiocarbamate,1134-23-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91a745ed-b6b9-422b-aebe-bb7341bfd04d/documents/3b1e4d6f-ae02-4a5e-b376-c3c78cbd3f7a_0e93746e-ba24-44ca-9054-2d70e823367d.html,Chronic toxicity – systemic effects,oral,NOAEL,21 mg/kg bw/day,,rat S-ethyl N-cyclohexylthiocarbamate,1134-23-2,"Migrated Data from field(s)Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliableField ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): more than 4640 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91a745ed-b6b9-422b-aebe-bb7341bfd04d/documents/77a82e3a-e4ec-4dfe-bbcc-f214dad55bbd_0e93746e-ba24-44ca-9054-2d70e823367d.html,,,,,, S-ethyl N-cyclohexylthiocarbamate,1134-23-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91a745ed-b6b9-422b-aebe-bb7341bfd04d/documents/77a82e3a-e4ec-4dfe-bbcc-f214dad55bbd_0e93746e-ba24-44ca-9054-2d70e823367d.html,,oral,LD50,"2,710 mg/kg bw",no adverse effect observed, S-ethyl N-cyclohexylthiocarbamate,1134-23-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91a745ed-b6b9-422b-aebe-bb7341bfd04d/documents/77a82e3a-e4ec-4dfe-bbcc-f214dad55bbd_0e93746e-ba24-44ca-9054-2d70e823367d.html,,dermal,LD50,"4,640 mg/kg bw",, S-ethyl N-cyclohexylthiocarbamate,1134-23-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91a745ed-b6b9-422b-aebe-bb7341bfd04d/documents/77a82e3a-e4ec-4dfe-bbcc-f214dad55bbd_0e93746e-ba24-44ca-9054-2d70e823367d.html,,inhalation,LC50,"4,700 mg/m3",no adverse effect observed, Shale oils,68308-34-9," Studies on repeated dose toxicity have therefore been waived in consideration of the provisions provided in Annex XI of the regulation, Section 1 (testing does not appear scientifically necessary) on the basis of section 1.1 “use of existing data” and section 1.2 “weight of evidence” for the following reasons:  1. An assessment of the hazard classifications of all constituents within shale oil did not indicate any concern regarding repeated dose toxicity. 2. The PAH component of shale oil is considered to drive the long term toxicological hazards for the registered substance. Since benzo[a]pyrene was the only identified PAH, and bearing in mind its stringent hazard classification, as part of a conservative approach, this substance has been used as the surrogate PAH substance within shale oil. Available repeated doe toxicity data on benzo[a]pyrene are therefore included within the substance dataset and are considered to provide conservative assessment of long term toxicological hazard of the registered substance. 3. The OEL for benzo[a]pyrene has been used to derive the relevant DNELs for the registered substance and has been shown to provide more conservative values than utilising the Virtually Safe Dose as determined by the Dutch authorities following long term testing with benzo[a]pyrene. 4. Upon consideration of the CMR (category 1B) classification, strict operating controls and rigorous risk management measures are implemented on site to ensure safe use, to mitigate CMR risk. These measures are considered protective for any other potential toxicological risk, including repeated dose toxicity. In summary, the risk assessment is performed based on the most toxicologically relevant component, benzo(a)pyrene. Classification and DNELs can be derived based on calculation from the OEL recognised at European level. Even at 5% , the presence of PAHs are still the only component that need to be taken into consideration in the derivation of DNELs, because comparison of existing reference doses and exposure limits show that for PAHs are 10,000 lower than next lowest reference dose i.e. extrapolating the OEL for each oil fraction from the PAH content still results in the lowers OEL, than if were done based on the content of the remaining materials. Please refer to the document ‘Consideration of the long term toxicity of Distillates (shale oil)’, as included in section 13, for further information. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62bc2adf-cef3-4e4e-87d0-33e39192ec8a/documents/IUC5-7c3ab7ff-e09a-4f34-9763-3246ff1139f1_04cad3d3-ab8f-46d0-b8e8-897e2060c0ff.html,,,,,, Shale oils,68308-34-9," The median lethal dose of Shale oil after single oral administration to female rats, observed over a period of 14 days is: LD50 (female rat): greater than 2000 mg/kg body weight. The median lethal dose of Shale oil after single dermal administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat): greater than 2000 mg/kg body weight. Supporting data The median lethal dose of Generator oil after 2 hours exposure to white mice, observed over a period of 14 days was 19 mg/L. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62bc2adf-cef3-4e4e-87d0-33e39192ec8a/documents/IUC5-2b9cb7d0-a2e0-4fda-88a2-5301764b0a52_04cad3d3-ab8f-46d0-b8e8-897e2060c0ff.html,,,,,, Shale oils,68308-34-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62bc2adf-cef3-4e4e-87d0-33e39192ec8a/documents/IUC5-2b9cb7d0-a2e0-4fda-88a2-5301764b0a52_04cad3d3-ab8f-46d0-b8e8-897e2060c0ff.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Shale oils,68308-34-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62bc2adf-cef3-4e4e-87d0-33e39192ec8a/documents/IUC5-2b9cb7d0-a2e0-4fda-88a2-5301764b0a52_04cad3d3-ab8f-46d0-b8e8-897e2060c0ff.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Shale oils,68308-34-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62bc2adf-cef3-4e4e-87d0-33e39192ec8a/documents/IUC5-2b9cb7d0-a2e0-4fda-88a2-5301764b0a52_04cad3d3-ab8f-46d0-b8e8-897e2060c0ff.html,,inhalation,LC50,"19,000 mg/m3",, Silane,7803-62-5,"There is one study (Omae et al., 1992, Reliability score 2) for repeated dose inhalation of silane (CAS 7803-62-5; EC No. 232-263-4) conducted using a protocol similar to OECD Test Guideline 412 (no information on GLP status) in male ICR mice. Following exposure for 6 hours/day, 5 days/week for four weeks to 1000 ppm silane, no adverse effects were recorded. Therefore, the NOAEC was considered to be ≥1000 ppm (≥1310 mg/m3).  There are no oral or dermal repeated dose toxicity studies.   There is one study (Omae et al., 1992, Reliability score 2) for repeated dose inhalation of silane conducted using a protocol similar to OECD Test Guideline 412 (no information on GLP status) in male ICR mice. Following exposure for 6 hours/day, 5 day/week for four weeks to 1000 ppm silane, no adverse effects were recorded. Therefore, the NOAEC was considered to be ≥1000 ppm (≥1310 mg/m3). There are no oral or dermal repeated dose toxicity studies.   There is one study (Omae et al., 1992, Reliability score 2) for repeated dose inhalation of silane conducted using a protocol similar to OECD Test Guideline 412 (no information on GLP status) in male ICR mice. Following exposure for 6 hours/day, 5 day/week for four weeks to 1000 ppm silane, no adverse effects were recorded. Therefore, the NOAEC was considered to be ≥1000 ppm (≥1310 mg/m3). There are no oral or dermal repeated dose toxicity studies.   There is one study (Omae et al., 1992, Reliability score 2) for repeated dose inhalation of silane conducted using a protocol similar to OECD Test Guideline 412 (no information on GLP status) in male ICR mice. Following exposure for 6 hours/day, 5 day/week for four weeks to 1000 ppm silane, no adverse effects were recorded. Therefore, the NOAEC was considered to be ≥1000 ppm (≥1310 mg/m3). There are no oral or dermal repeated dose toxicity studies.   There is one study (Omae et al., 1992, Reliability score 2) for repeated dose inhalation of silane conducted using a protocol similar to OECD Test Guideline 412 (no information on GLP status) in male ICR mice. Following exposure for 6 hours/day, 5 day/week for four weeks to 1000 ppm silane, no adverse effects were recorded. Therefore, the NOAEC was considered to be ≥1000 ppm (≥1310 mg/m3). There are no oral or dermal repeated dose toxicity studies.   There is one study (Omae et al., 1992, Reliability score 2) for repeated dose inhalation of silane conducted using a protocol similar to OECD Test Guideline 412 (no information on GLP status) in male ICR mice. Following exposure for 6 hours/day, 5 day/week for four weeks to 1000 ppm silane, no adverse effects were recorded. Therefore, the NOAEC was considered to be ≥1000 ppm (≥1310 mg/m3). There are no oral or dermal repeated dose toxicity studies. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25749831-1d4a-470c-a444-b28f728a8c9f/documents/12d6c42f-a437-4b92-ad54-ac4454b19f9c_8e90048a-0e94-468f-ba61-020fcce761ee.html,,,,,, Silane,7803-62-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25749831-1d4a-470c-a444-b28f728a8c9f/documents/12d6c42f-a437-4b92-ad54-ac4454b19f9c_8e90048a-0e94-468f-ba61-020fcce761ee.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,310 mg/m3",,mouse Silane,7803-62-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25749831-1d4a-470c-a444-b28f728a8c9f/documents/12d6c42f-a437-4b92-ad54-ac4454b19f9c_8e90048a-0e94-468f-ba61-020fcce761ee.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,310 mg/m3",no adverse effect observed,mouse Silane,7803-62-5," In the key acute inhalation study (Toxic Hazard Research Unit, 1972, reliability score 2) conducted using a protocol similar to OECD Test Guideline 403 (reliability score 2) and prior to the introduction of GLP, a concentration of 9600 ppm (12611 mg/m3) silane (CAS 7803-62-5; EC No. 232-263-4) for four hours caused deaths in 4 of 10 mice. A concentration of 9600 ppm (12611 mg/m3) for 4 hours did not cause any deaths in five rats. Hence the LC50s for mice and rats were approximately 10000 ppm and >9600 ppm, respectively. There are no acute oral or dermal toxicity studies available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25749831-1d4a-470c-a444-b28f728a8c9f/documents/c67342cc-2b99-4167-a0cb-d97bf69ffc5c_8e90048a-0e94-468f-ba61-020fcce761ee.html,,,,,, Silane,7803-62-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25749831-1d4a-470c-a444-b28f728a8c9f/documents/c67342cc-2b99-4167-a0cb-d97bf69ffc5c_8e90048a-0e94-468f-ba61-020fcce761ee.html,,inhalation,LC50,"> 12,611 mg/m3",no adverse effect observed, triethyl[[4-(triethylsilyl)-3-butyn-1-yl]oxy]silane,160194-28-5,"The oral LD50 value of Bis-Tes (dried) in Wistar rats was established to exceed 2000 mg/kg body weight.According to the OECD 423 test guideline, the LD50 cut-off value was considered to exceed 5000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8d3f650-f4fa-4908-a0d9-f9e6cad220fa/documents/IUC5-6e52aab5-cc2e-4b39-8768-682ee02ed1f9_69964a6c-291e-4f9c-903c-504e6c61fc4c.html,,,,,, triethyl[[4-(triethylsilyl)-3-butyn-1-yl]oxy]silane,160194-28-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c8d3f650-f4fa-4908-a0d9-f9e6cad220fa/documents/IUC5-6e52aab5-cc2e-4b39-8768-682ee02ed1f9_69964a6c-291e-4f9c-903c-504e6c61fc4c.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Silicic acid (H2Si2O5), barium salt (1:1), lead-doped",68784-75-8,"Silicic acid (H2Si2O5), barium salt (1:1), lead-doped was administered by daily oral gavage to male and female Wistar Han rats at dose levels of 30, 100 and 300 mg/kg/day. Males were exposed for 2 weeks prior to mating, during mating, and up to termination (for a total of 28 days). The females were exposed for 2 weeks prior to mating, during mating, during post-mating, and at least 4 days of lactation (for 41-47 days). Based on mortality and clinical signs the parental NOAEL was determined to be 30 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb77a60e-96ef-4ac5-95cf-2d3490b6c65e/documents/422123bb-d34c-43d7-885b-59c7f384bcb4_2e268125-5ed7-4d4a-aad4-8dc65d435937.html,,,,,, "Silicic acid (H2Si2O5), barium salt (1:1), lead-doped",68784-75-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bb77a60e-96ef-4ac5-95cf-2d3490b6c65e/documents/422123bb-d34c-43d7-885b-59c7f384bcb4_2e268125-5ed7-4d4a-aad4-8dc65d435937.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "Silicic acid (H2Si2O5), barium salt (1:1), lead-doped",68784-75-8,"The oral LD50 value of Silicic acid(H2Si2O5), barium salt(1:1), lead-doped in Wistar rats was established to be within the range of 300-2000 mg/kg body weight. The dermal LD50 value of Silicic acid(H2Si2O5), barium salt(1:1), lead-doped in Wistar rats was established to exceed 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb77a60e-96ef-4ac5-95cf-2d3490b6c65e/documents/bbeed05e-4a92-4fd8-b464-489de5448a63_2e268125-5ed7-4d4a-aad4-8dc65d435937.html,,,,,, "Silicic acid (H2Si2O5), barium salt (1:1), lead-doped",68784-75-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb77a60e-96ef-4ac5-95cf-2d3490b6c65e/documents/bbeed05e-4a92-4fd8-b464-489de5448a63_2e268125-5ed7-4d4a-aad4-8dc65d435937.html,,oral,LD50,300 mg/kg bw,, "Silicic acid (H2Si2O5), barium salt (1:1), lead-doped",68784-75-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb77a60e-96ef-4ac5-95cf-2d3490b6c65e/documents/bbeed05e-4a92-4fd8-b464-489de5448a63_2e268125-5ed7-4d4a-aad4-8dc65d435937.html,,dermal,LD50,"5,000 mg/kg bw",, "Silicic acid (H4SiO4), mixed 2-butoxyethyl and methyl tetraesters",1185356-03-9,"The repeated toxicity of Silane 198 was evaluated in two studies where groups of rats were exposed to Silane 198 by oral route (gavage) during 28 days. Based on the results, the NOAEL for the systemic effects is 50 mg/kg/day based on adverse effects observed in liver, blood and spleen. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The database is considered to be reliable and adequate with 2 studies. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22c97ab5-7f4d-4d07-8557-df6aad6bee4b/documents/57cbc9bd-a0a7-4c56-903c-fac683bfa9f7_fd936a67-278f-4ade-8fcd-4cefaabb9b0b.html,,,,,, "Silicic acid (H4SiO4), mixed 2-butoxyethyl and methyl tetraesters",1185356-03-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22c97ab5-7f4d-4d07-8557-df6aad6bee4b/documents/57cbc9bd-a0a7-4c56-903c-fac683bfa9f7_fd936a67-278f-4ade-8fcd-4cefaabb9b0b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Silicic acid (H4SiO4), mixed 2-butoxyethyl and methyl tetraesters",1185356-03-9,"The acute toxicity of Silane 198 was evaluated after single oral, dermal and inhalation exposure in rats. Based on the results obtained, Silane 198 is not harmful by oral and dermal route,  however Silane 198 is fatal if inhaled (LC50 = 0.05 mg/L).   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The database for this endpoint is considered to be reliable with same results obtained in two studies. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The database for this endpoint is considered to be reliable. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The database for this endpoint is considered to be reliable with same results obtained in two studies. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22c97ab5-7f4d-4d07-8557-df6aad6bee4b/documents/64d4c58f-f918-41bd-ac73-82a6d1aa92c4_fd936a67-278f-4ade-8fcd-4cefaabb9b0b.html,,,,,, "Silicic acid (H4SiO4), mixed 2-butoxyethyl and methyl tetraesters",1185356-03-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22c97ab5-7f4d-4d07-8557-df6aad6bee4b/documents/64d4c58f-f918-41bd-ac73-82a6d1aa92c4_fd936a67-278f-4ade-8fcd-4cefaabb9b0b.html,,oral,LD50,"> 2,008 mg/kg bw",adverse effect observed, "Silicic acid (H4SiO4), mixed 2-butoxyethyl and methyl tetraesters",1185356-03-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22c97ab5-7f4d-4d07-8557-df6aad6bee4b/documents/64d4c58f-f918-41bd-ac73-82a6d1aa92c4_fd936a67-278f-4ade-8fcd-4cefaabb9b0b.html,,dermal,LD0,"2,008 mg/kg bw",no adverse effect observed, "Silicic acid (H4SiO4), mixed 2-butoxyethyl and methyl tetraesters",1185356-03-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22c97ab5-7f4d-4d07-8557-df6aad6bee4b/documents/64d4c58f-f918-41bd-ac73-82a6d1aa92c4_fd936a67-278f-4ade-8fcd-4cefaabb9b0b.html,,inhalation,LC50,>=0.05 mg/L,adverse effect observed, "Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dibutylstannane",93925-42-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ee4d58a-7677-407c-b0d0-cc135dbf5a58/documents/IUC5-5d8c5373-643f-4bfc-974c-821432ac1d6e_945d4700-76b7-4118-ab14-c48da0ee7ba3.html,,oral,LD50,"1,000 mg/kg bw",, "Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dibutylstannane",93925-42-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ee4d58a-7677-407c-b0d0-cc135dbf5a58/documents/IUC5-5d8c5373-643f-4bfc-974c-821432ac1d6e_945d4700-76b7-4118-ab14-c48da0ee7ba3.html,,inhalation,LC50,1.555 mg/m3,, "Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dioctylstannane",93925-43-0," Short-term toxicity oral (OECD 407, rats): LOAEL = 10 mg/kg bw/day; no NOAEL could be established Repested dose toxicity-oral (Read Across to DOTO): NOAEL for general toxicity is established on the low-dose level (5 mg/kg diet which is equivalent to 0.3-0.4 mg/kg body weight/day for the male animals and to 0.3-0.5 mg/kg body weight/day for the female animals). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/afefa302-f61b-4f3c-ba80-f0f59c3976cf/documents/2960f2c2-e4b4-403d-8d5b-4f64cf05c83e_c91051ee-0055-4853-82ec-9b31f782bca2.html,,,,,, "Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dioctylstannane",93925-43-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/afefa302-f61b-4f3c-ba80-f0f59c3976cf/documents/2960f2c2-e4b4-403d-8d5b-4f64cf05c83e_c91051ee-0055-4853-82ec-9b31f782bca2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,0.3 mg/kg bw/day,,rat "Silicic acid (H4SiO4), tetraethyl ester, reaction products with bis(acetyloxy)dioctylstannane",93925-43-0," Oral (OECD 423), rat: LD50 cut off = 5000 mg/kg bw (limit test) Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw (limit test) Inhalation: The study does not need to be conducted as exposure of humans via inhalation is unlikely taking into account the very low vapour pressure of the substance (< 8.4E-7 Pa at 20°C). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/afefa302-f61b-4f3c-ba80-f0f59c3976cf/documents/c342e01c-804e-435e-9b44-8852218850b0_c91051ee-0055-4853-82ec-9b31f782bca2.html,,,,,, "Silicic acid (H4SiO4), zirconium(4+) salt (1:1), reaction products with sodium hydroxide",94279-56-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/164a1c4f-7cf1-4d97-a51a-c7c5d826a86b/documents/IUC5-a10b539d-ca78-4142-b018-c8fc832c54a5_4d0f7d6b-4bd8-4603-aec3-d1bd8dc87b05.html,,oral,LD50,"1,372 mg/kg bw",adverse effect observed, "Silicic acid, aluminum salt",1335-30-4,Oral: Read Across from Syloid 244:NOAEL (male): 1760 - 3000 mg/kg bw/day for ratsNOAEL (female): 1780 - 3210 mg/kg bw/day for ratsNOAEL (male): 5270 - 7490 mg/kg bw/day for miceNOAEL (female): 3950 - 13310 mg/kg bw/day for miceDermalNo dermal repeated dose toxicity studies.Inhalation: Read Across from Aerosil 200NOAEC: 1.3 mg/m³ for rats ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f94c83fd-f9f9-4b47-8ebe-51b6058cbe83/documents/IUC5-cf3c5b33-6886-41e9-b1ea-6ff0bd05d76a_4466f461-c480-4166-8bea-67356a551a1e.html,,,,,, "Silicic acid, aluminum salt",1335-30-4,"Oral: LD50: > 2000 mg/kg bw for ratsInhalation: LC50: > 2.07 mg/L , 4 hours, limit test, rats (RA calcined Kaolin)Dermal: LD50: > 5000 mg/kg bw for rabbit after 2 observation days (RA Silicic acid, aluminium sodium salt) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f94c83fd-f9f9-4b47-8ebe-51b6058cbe83/documents/IUC5-c38e1296-31a0-45a5-b5bf-1dce55f31a2b_4466f461-c480-4166-8bea-67356a551a1e.html,,,,,, "Silicic acid, lead salt",11120-22-2,"Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function including the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/665ce1d5-ebdb-46d2-b75d-2622615ed78f/documents/IUC5-c19d3ccf-83e6-463b-b797-5fa0ef299d3a_bc1e08d9-e2ce-4264-a3ce-d84f73b146a3.html,,,,,, "Silicic acid, lead salt",11120-22-2,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/665ce1d5-ebdb-46d2-b75d-2622615ed78f/documents/IUC5-c19d3ccf-83e6-463b-b797-5fa0ef299d3a_bc1e08d9-e2ce-4264-a3ce-d84f73b146a3.html,Chronic toxicity – systemic effects,oral,LOAEL,0.005 mg/kg bw/day,,rat "Silicic acid, lead salt",11120-22-2,Inorganic lead compounds do not exhit toxicity in acute toxicity tests with experimental animals. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/665ce1d5-ebdb-46d2-b75d-2622615ed78f/documents/IUC5-9bc9a429-3f5c-4a1e-a5d6-455295e61ac6_bc1e08d9-e2ce-4264-a3ce-d84f73b146a3.html,,,,,, "Silicic acid, lead salt",11120-22-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/665ce1d5-ebdb-46d2-b75d-2622615ed78f/documents/IUC5-9bc9a429-3f5c-4a1e-a5d6-455295e61ac6_bc1e08d9-e2ce-4264-a3ce-d84f73b146a3.html,,oral,LD50,"5,000 mg/kg bw",, "Silicic acid, lead salt",11120-22-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/665ce1d5-ebdb-46d2-b75d-2622615ed78f/documents/IUC5-9bc9a429-3f5c-4a1e-a5d6-455295e61ac6_bc1e08d9-e2ce-4264-a3ce-d84f73b146a3.html,,dermal,LD50,"2,000 mg/kg bw",, "Silicic acid, lead salt",11120-22-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/665ce1d5-ebdb-46d2-b75d-2622615ed78f/documents/IUC5-9bc9a429-3f5c-4a1e-a5d6-455295e61ac6_bc1e08d9-e2ce-4264-a3ce-d84f73b146a3.html,,inhalation,LC50,"5,050 mg/m3",, "Silicic acid, lithium salt",12627-14-4,"Repeated dose toxicity studies with the structural analogue substances silicic acid, sodium salt or disodium metasilicate ranging from 4 weeks to 180 days have been conducted in rats, mice and dogs. From these studies a NOAEL (90d) of 227 - 237 mg/kg bw/day can be derived for rats. The NOAEL (90d) for mice is 260 – 284 mg/kg bw/day. From a 2-year drinking water study in rats with lithium chloride a NOAEL of 15.3 mg lithium/kg bw/day corresponding to 219 mg silicic acid lithium salt (MR: 2.8)/kg bw/day was derived. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c288bd6-a9bb-4897-94f6-997ff38aff09/documents/IUC5-bc7a6ef9-6370-485f-9b83-e25860cf960d_e4265b22-b708-4418-bbf6-993c0205c259.html,,,,,, "Silicic acid, lithium salt",12627-14-4,"Oral (OECD 423), rat: LD50 cut-off: 2500 mg/kg bw (limit test)Inhalation: due to physicochemical properties inhalation is unlikely to occurDermal: negligible dermal absorption through the skin ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c288bd6-a9bb-4897-94f6-997ff38aff09/documents/IUC5-2e84978b-ded2-4724-a74a-f898f6e7ee2c_e4265b22-b708-4418-bbf6-993c0205c259.html,,,,,, "Silicic acid, lithium salt",12627-14-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c288bd6-a9bb-4897-94f6-997ff38aff09/documents/IUC5-2e84978b-ded2-4724-a74a-f898f6e7ee2c_e4265b22-b708-4418-bbf6-993c0205c259.html,,oral,LD50,"2,500 mg/kg bw",, Boron silicate,12676-29-8,28d inhalation toxicity study: NOAEC systemic 250 mg/m328d inhalation toxicity study: NOAEC local 10 mg/m3 ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c7179ed-d22c-4788-aacd-d7b101875ce6/documents/IUC5-fdfec998-e55d-4cfc-8b41-9f521b7a5bd5_df672f72-cd5e-4ef0-a598-ba6c080cb990.html,,,,,, Boron silicate,12676-29-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c7179ed-d22c-4788-aacd-d7b101875ce6/documents/IUC5-fdfec998-e55d-4cfc-8b41-9f521b7a5bd5_df672f72-cd5e-4ef0-a598-ba6c080cb990.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,250 mg/m3,,rat Boron silicate,12676-29-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c7179ed-d22c-4788-aacd-d7b101875ce6/documents/IUC5-fdfec998-e55d-4cfc-8b41-9f521b7a5bd5_df672f72-cd5e-4ef0-a598-ba6c080cb990.html,Repeated dose toxicity – local effects,inhalation,NOAEC,10 mg/m3,adverse effect observed,rat Boron silicate,12676-29-8,LD50 oral >2000 mg/kg bwLD50 dermal >5000 mg/kg bwLC50 inhalation >5.5 mg/L ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c7179ed-d22c-4788-aacd-d7b101875ce6/documents/IUC5-0f4e45d9-5aa9-4255-a170-eade18aaed1f_df672f72-cd5e-4ef0-a598-ba6c080cb990.html,,,,,, Boron silicate,12676-29-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c7179ed-d22c-4788-aacd-d7b101875ce6/documents/IUC5-0f4e45d9-5aa9-4255-a170-eade18aaed1f_df672f72-cd5e-4ef0-a598-ba6c080cb990.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Boron silicate,12676-29-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c7179ed-d22c-4788-aacd-d7b101875ce6/documents/IUC5-0f4e45d9-5aa9-4255-a170-eade18aaed1f_df672f72-cd5e-4ef0-a598-ba6c080cb990.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Boron silicate,12676-29-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c7179ed-d22c-4788-aacd-d7b101875ce6/documents/IUC5-0f4e45d9-5aa9-4255-a170-eade18aaed1f_df672f72-cd5e-4ef0-a598-ba6c080cb990.html,,inhalation,LC50,"5,500 mg/m3",no adverse effect observed, Silicon orthophosphate,12037-47-7,"Oral (OECD 408, silicon dioxide), subchronic, rat: NOAEL (systemic), males/females = ≥4000-4500 mg/kg bw/dayOral (dipotassium hydrogenorthophosphate), subchronic, dog: LOAEL (systemic), males/females = 800 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05683fd9-e7f9-42e6-a605-39b421a66ceb/documents/IUC5-a612de90-534b-4765-a87c-0a48c385d4ff_5ddcd055-3f9a-4223-a5a3-cff1a2970461.html,,,,,, Silicon orthophosphate,12037-47-7,"Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw (limit test) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05683fd9-e7f9-42e6-a605-39b421a66ceb/documents/IUC5-4d301265-0ca3-4c1b-ae14-ec86f7d1c12b_5ddcd055-3f9a-4223-a5a3-cff1a2970461.html,,,,,, Silicon tetrachloride,10026-04-7," No data are available for the repeated dose oral toxicity of silicon tetrachloride therefore, good quality data for the precipitated hydrolysis product, synthetic amorphous silica (SAS) have been used to address the potential for systemic toxicity. In a repeat dose 90-day oral toxicity study (Kim et al., 2014) with Sprague-Dawley rats, two forms of synthetic amorphous silica (SAS and NM-202; differing in particle size and specific surface area) were administered (vehicle: water) by oral gavage for 90 consecutive days at a dose of 500, 1000 or 2000 mg/kg bw/day (10 animals/sex/group). The particles were described as either 20 or 100 nm in diameter. Extra animals were included in the control (received water only) and highest dose groups to allow for a two-week post-exposure recovery period. Observations were made according to OECD Test Guideline 408. For 20 and 100 nm silica samples the findings were sporadic and without a dose-response, so were concluded by the study authors to be not treatment-related. The NOAEL for both particle sizes was therefore concluded to be ≥2000 mg/kg bw/day. Since the local corrosive effects of chlorosilanes are significant, valid oral or inhalation studies according to the relevant guidelines are technically not feasible. It is also unlikely that any systemic effects would be observed at doses made sufficiently low to prevent the known corrosive effects and/or distress in the test species. Indeed, ECHA’s Executive Director made the following statement in his decision (No. ED/49/2015) for trichlorosilane “ECHA notes that the Contested Decision should not have provided the option of carrying out the PNDT study on the registered substance, which is corrosive and consequently can only be tested at very low concentrations. In a PNDT study, which normally requires high systematic availability of the tested substance, the very low concentrations would almost certainly lead to a negative result”. To support this conclusion, a 28-day inhalation study with another chlorosilane, dichloro(dimethyl)silane (CAS 75-78-5, WIL, 2014) is used to demonstrate that local effects are dominated by generation of the hydrolysis product, HCl, and that there are no adverse systemic effects. For local effects, a good quality study on hydrogen chloride is available. In a 90-day repeated dose inhalation study in rats and mice (Toxigenics, 1984), 31 males and 21 females of each species/strain were exposed to test concentrations of 0, 10, 20 and 50 ppm hydrogen chloride gas (HCl). Treatment was whole-body exposure for six hours per day, 5 days per week. No serious adverse systemic effects were observed in rats and mice exposed up to 50 ppm (approximately 70 mg/m3) for 6 hours per day, 5 days per week. The only significant adverse finding relating to systemic toxicity was decreased body weight at the highest dose level. The No Observed Adverse Effect Concentration (NOAEC) for systemic effects was determined to be 20 ppm (approximately 30 mg/m3) based on decreased body weight following exposure to 50 ppm. Local effects on the nasal turbinates of mice were observed at all dose levels tested (10, 20 and 50 ppm). No NOAEC for local effects was established as irritant/corrosive effects were observed at all dose levels tested. Therefore, a LOAEC of 10 ppm was concluded. No suitable dermal data are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5192c69a-5564-46fa-ae31-cecc099f396a/documents/b5bd4512-4ae4-4381-8c49-5dd6d023d4a1_1c82a3a3-b4b7-4cc1-ba6a-16dcefc2ee09.html,,,,,, Silicon tetrachloride,10026-04-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5192c69a-5564-46fa-ae31-cecc099f396a/documents/b5bd4512-4ae4-4381-8c49-5dd6d023d4a1_1c82a3a3-b4b7-4cc1-ba6a-16dcefc2ee09.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,000 mg/kg bw/day",,rat Silicon tetrachloride,10026-04-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5192c69a-5564-46fa-ae31-cecc099f396a/documents/b5bd4512-4ae4-4381-8c49-5dd6d023d4a1_1c82a3a3-b4b7-4cc1-ba6a-16dcefc2ee09.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 mg/m3,adverse effect observed,rat Silicon tetrachloride,10026-04-7," In the key acute oral toxicity study, conducted according to a protocol similar to the now-deleted OECD Test Guideline 401 and pre-GLP, an LD50 for silicon tetrachloride was concluded to be 238 mg/kg bw in rats (Younger Laboratories, 1967). In the key acute inhalation toxicity study, conducted according to a protocol similar to OECD Test Guideline 403 and in compliance with GLP, an LC50 value of 1312 ppm (equivalent to 9117 mg/m3 based on MW of 169.9 g/mol) was concluded (Dow Corning Corporation, 1997). In the key acute dermal toxicity study, conducted according to a protocol similar to OECD Test Guideline 402 but pre-GLP, no mortalities occurred and an LD50 of >10,000 mg/kg bw was concluded (Younger Laboratories, 1967). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5192c69a-5564-46fa-ae31-cecc099f396a/documents/86c10a15-b21f-4483-89de-bc6517aeb090_1c82a3a3-b4b7-4cc1-ba6a-16dcefc2ee09.html,,,,,, Silicon tetrachloride,10026-04-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5192c69a-5564-46fa-ae31-cecc099f396a/documents/86c10a15-b21f-4483-89de-bc6517aeb090_1c82a3a3-b4b7-4cc1-ba6a-16dcefc2ee09.html,,oral,LD50,238 mg/kg bw,adverse effect observed, Silicon tetrachloride,10026-04-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5192c69a-5564-46fa-ae31-cecc099f396a/documents/86c10a15-b21f-4483-89de-bc6517aeb090_1c82a3a3-b4b7-4cc1-ba6a-16dcefc2ee09.html,,dermal,LD50,"10,000 mg/kg bw",no adverse effect observed, Silicon tetrachloride,10026-04-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5192c69a-5564-46fa-ae31-cecc099f396a/documents/86c10a15-b21f-4483-89de-bc6517aeb090_1c82a3a3-b4b7-4cc1-ba6a-16dcefc2ee09.html,,inhalation,LC50,"9,117 mg/m3",adverse effect observed, Silver bromide,7785-23-1,"  A read-across approach from silver acetate (as source substance) is used for other silver compounds. The Toxicokinetic study confirmed the read-across between silver acetate and other silver compounds. For further details please refer to separate report ""CSR Annex 7 Read Across Justification Human Health_Nov 2022"" which is attached to the CSR in section 13. Key information considered: Lourens et al. 2022 performed a repeated dose toxicity (90-days) study according to OECD 408 and following GLP principles, with silver acetate administered via the diet to Wistar Han rats at 40, 120 and 320 mg/kg bw/day. Based on the results, the NOAEL was a target dose level of 120 mg/kg bw/day for males and a target dose of at least 320 mg/kg bw/day for female. Hadrup et al. 2012 conducted a subacute (28-day) oral toxicity study comparing the effects of silver acetate to those of nanoscale silver (see also below). Silver acetate was tested at only one dose (14 mg/kg bw/d, corresponding to 9 mg silver/kg bw/d) and in female rats only (for data on silver nanomaterials, see below). Oral exposure to silver in ionic form (as acetate) was reported by the authors to be associated with lower body weight gain, an increase in ALP and a decrease in urea concentrations in plasma and lower absolute and relative thymus weights. In lack of other more conclusive data, this study despite its limitations indicates a tentative LOEL for ionic silver of 9 mg/kg bw/d. Boudreau et al. 2016 conducted a 90-day (OECD 408) oral toxicity study.  Sprague Dawley rats of seven-week-old rats (10 rats per sex per group) were dosed with silver acetate (AgAc) at 100, 200, and 400 mg/kg bw; and controls (water). Rats exposed to AgAc at high dose (400 mg/kg bw/day) presented high morbidity with 70% of female and 100% of male rats being removed prior to the scheduled terminal sacrificed. Clinical findings suggested severe gastrointestinal symptoms, loss of body weight and unthrifty appearance among these animas, likely due to the bactericidal activity of silver ion on the intestinal microbiota. Significant lower mean body weight were observed in female rats administered of 100 and 400 of AgAc; the overall mean body weights were 88.5% and 74.4% of the control groups. Male rats administered with 400 and 200 mg/kg bw/d demonstrated significantly lower mean body weight than the controls, beginning at week 1 and week 3, respectively. body weight of male rats administered 100 mg/kg bw/d were not significantly affected. At the highest dose, the absolute heart and thymus weight were lower when compared with controls. Lourens et al. 2022 (NOAEL of 120 and 320 mg AgAc/ kg bw/day for males and females respectively) was assessed. However, the study was not selected as starting point to derive the DNEL for silver compounds because the NOAELs decribed in this study were considered not conservative enough. Therefore, it is the LOAEL of 40 mg AgAc/kg bw/day defined by the EOGRTS (F0 generation - exposed during 135 days (in total)) that was used as a starting point. For further details, please refer to separate report ""CSR Annex 2_Derivation of DNEL_2022"" which is attached to the CSR in section 13. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3ebb90d-00a4-4b9c-8062-301bcf3548e2/documents/c9f8c985-a54e-4aa1-a51e-8551ec5e6736_d54860d0-1950-4248-8bc5-6a2304fb5729.html,,,,,, Silver bromide,7785-23-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3ebb90d-00a4-4b9c-8062-301bcf3548e2/documents/c9f8c985-a54e-4aa1-a51e-8551ec5e6736_d54860d0-1950-4248-8bc5-6a2304fb5729.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat Silver bromide,7785-23-1," There is no acute oral toxicity data available for silver bromide. Read-across is applied to silver chloride. For the most comparable compounds, AgCl, an LD50 oral of >5110 mg/kg has been determined. It is noted that the solubility of AgBr (140 µg/L) is even lower than for AgCl (1.9 mg/L). Testing for acute oral toxicity for AgBr is thus not considered to be scientifically justified. Testing for acute inhalation toxicity is also scientifically unjustified for AgBr (see respective justification for waiving). Testing for acute dermal toxicity is scientifically not justified for AgBr, because of the low potential for any dermal penetration (see section on toxicokinetics) and the generally low acute, systemic toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3ebb90d-00a4-4b9c-8062-301bcf3548e2/documents/IUC5-d1675b2c-ce48-46b2-aa44-119f2e2f1f08_d54860d0-1950-4248-8bc5-6a2304fb5729.html,,,,,, Silver cyanide,506-64-9,"Repeat dose oral toxicity study in rats to test guideline OECD422 standard. Animals were treated daily at dose levels of 5, 15 and 50/40mg/kg/day for a total of 38 days for males and 39 days for females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06f0ba92-7531-4e3d-863b-ee707b85d7bd/documents/IUC5-32fb912e-8067-48fb-b38f-84056feca69f_915090e0-c3e3-4c17-8cf7-d1dfd1e5fd30.html,,,,,, Silver cyanide,506-64-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06f0ba92-7531-4e3d-863b-ee707b85d7bd/documents/IUC5-32fb912e-8067-48fb-b38f-84056feca69f_915090e0-c3e3-4c17-8cf7-d1dfd1e5fd30.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat Silver cyanide,506-64-9,"Acute oral toxicity study in rats by the ""up-and-down"" procedure according to OECD425 guideline.Acute dermal toxicity study in rats, limit dose procedure according to OECD402 guideline. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06f0ba92-7531-4e3d-863b-ee707b85d7bd/documents/IUC5-ad98d989-83b4-4b47-8f78-b2885e66fa16_915090e0-c3e3-4c17-8cf7-d1dfd1e5fd30.html,,,,,, Silver cyanide,506-64-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06f0ba92-7531-4e3d-863b-ee707b85d7bd/documents/IUC5-ad98d989-83b4-4b47-8f78-b2885e66fa16_915090e0-c3e3-4c17-8cf7-d1dfd1e5fd30.html,,oral,LD50,175 mg/kg bw,adverse effect observed, Silver docosanoate,2489-05-6,"There is only one key study on repeated dose toxicity with docosanoic acid. This chemical was studied for oral toxicity in rats according to the OECD combined repeated dose and reproductive/developmental toxicity test [OECD TG 422]. As the study was well controlled and conducted under GLP, it was considered to be appropriate to select this as a key study.The NOAEL for repeated dose toxicity in rats is considered to be 1,000 mg/kg/day in both sexes. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74cfd2f1-cf37-4b04-9084-74761e651eeb/documents/IUC5-ff3aedff-c990-4f0b-af74-3ec2fe368578_3688bdd3-1c7e-4949-9cf0-8cc19840aeb9.html,,,,,, Silver docosanoate,2489-05-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/74cfd2f1-cf37-4b04-9084-74761e651eeb/documents/IUC5-ff3aedff-c990-4f0b-af74-3ec2fe368578_3688bdd3-1c7e-4949-9cf0-8cc19840aeb9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Silver docosanoate,2489-05-6,Two acute toxicity tests were performed for the two most likely exposure routes: oral and dermal. In neither were effects observed in the highest tested dose (2000 mg/kg bw). The inhalation route was not tested. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74cfd2f1-cf37-4b04-9084-74761e651eeb/documents/IUC5-2fbdb725-73fa-4328-b72c-308566ef0e4b_3688bdd3-1c7e-4949-9cf0-8cc19840aeb9.html,,,,,, Silver iodide,7783-96-2,"There is no acute toxicity data available for silver iodide. Read-across is applied to other comparable silver substance.  The most comparable compounds is AgCl, a LD50 oral of > 5110 mg/kg bw (equivalent to 8370.6 mg/kg bw of silver iodide) has been determined. it is noted that the solubility of AgI (30µg/L) is even lower than for AgCl (1.9 mg/L). Testing for acute oral toxicity for AgI is thus not considered to be scientifically justified. Note: Acute toxicity study via dermal and inhalation route are not a requirement under Annex VII of Regulation 1907/2006.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable database ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22d2b19e-fbd0-4155-b66e-4dd70a7ed09b/documents/IUC5-392e8e8e-c22b-4af5-8587-310ccdbb42b0_93d88aaa-fba8-4b63-8070-c549d5329b91.html,,,,,, Silver iodide,7783-96-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22d2b19e-fbd0-4155-b66e-4dd70a7ed09b/documents/IUC5-392e8e8e-c22b-4af5-8587-310ccdbb42b0_93d88aaa-fba8-4b63-8070-c549d5329b91.html,,oral,LD50,"> 8,370.6 mg/kg bw",no adverse effect observed, "Slags, copper refining",67711-94-8,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/637cf67c-c43d-4c6d-bc72-614c9790dc52/documents/23e42324-a9b0-496c-9941-077901046486_12b017e2-d200-4cd8-befa-d10d4cb1dbad.html,,,,,, "Slags, copper refining",67711-94-8,The acute toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/637cf67c-c43d-4c6d-bc72-614c9790dc52/documents/768ec76f-2567-49b1-bf95-344a93eb4ba7_12b017e2-d200-4cd8-befa-d10d4cb1dbad.html,,,,,, "Slags, elec. furnace smelting, iron silicate",102110-59-8,"The main phase of Si/FeSi silicate consists of practically insoluble silicates, and therefore it is seen as justified to use read-across in studies on calcium silicate, sodium aluminium silicate, kaolin (an Al-silicate), nonfibrous glass (containing Ca-, Al, Mg- and borosilicates) and silica gel. As no data were found on repeated dose toxicity of Si/FeSi silicate, studies with these substances were useful for read-across.The experimental repeated dose toxicity by inhalation or by oral route of the read-across materials has appeared to be low. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6153a693-3772-4c9e-b9ce-c521ac5ec387/documents/IUC5-85f5e0d6-676d-44b6-ad1f-6f4840af49f0_f68a8869-9f34-42a7-a2d6-af69ba3ef305.html,,,,,, "Slags, elec. furnace smelting, iron silicate",102110-59-8,"Acute toxicity of Si/FeSi silicate has not been tested. However acute toxicity test with silicates, kaolin, and synthetic amorphous silica show very high LD50 values. Therefore it can be concluded that Si/FeSi-silicate is not acutely toxic. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6153a693-3772-4c9e-b9ce-c521ac5ec387/documents/IUC5-6a1c2a12-744b-4ddf-a3ff-947f53120daf_f68a8869-9f34-42a7-a2d6-af69ba3ef305.html,,,,,, "Slags, elec. furnace smelting, iron silicate",102110-59-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6153a693-3772-4c9e-b9ce-c521ac5ec387/documents/IUC5-6a1c2a12-744b-4ddf-a3ff-947f53120daf_f68a8869-9f34-42a7-a2d6-af69ba3ef305.html,,oral,LD50,"5,000 mg/kg bw",, "Slags, elec. furnace smelting, iron silicate",102110-59-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6153a693-3772-4c9e-b9ce-c521ac5ec387/documents/IUC5-6a1c2a12-744b-4ddf-a3ff-947f53120daf_f68a8869-9f34-42a7-a2d6-af69ba3ef305.html,,dermal,LD50,"5,000 mg/kg bw",, "Slags, elec. furnace smelting, iron silicate",102110-59-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6153a693-3772-4c9e-b9ce-c521ac5ec387/documents/IUC5-6a1c2a12-744b-4ddf-a3ff-947f53120daf_f68a8869-9f34-42a7-a2d6-af69ba3ef305.html,,inhalation,LC50,"2,000 mg/m3",, "Slags, ferrochromium-manufg.",69012-27-7,"There are no repeated dose toxicity studies on ferrochromium slags and therefore data on silicates are used for read-across. The toxicity of the metal anions is assumed to be negligible because of their low solubility. Even if the inhaled dust were pure chromium, the toxicity would be low, without systemic effects. The experimental repeated dose toxicity by inhalation or by oral route of the read-across materials (calcium silicate, sodium aluminium silicate, kaolin (an Al-silicate), nonfibrous glass (containing Ca-, Al, Mg- and borosilicates) and silica gel) has appeared to be low. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a5029c78-62cf-4096-9ba8-99f795f65911/documents/IUC5-baeb5ff3-fbd7-49d2-8009-f4cb8999361f_c5e941b6-1b39-4a80-93c2-af6d82bbf72e.html,,,,,, "Slags, ferrochromium-manufg.",69012-27-7,"Acute toxicity of FeCr slags has not been tested. However acute toxicity test with silicates, kaolin, synthetic amorphous silica and chromium(III) oxide show very high LD50 values. Therefore it can be concluded that FeCr-silicate is not either acutely toxic. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5029c78-62cf-4096-9ba8-99f795f65911/documents/IUC5-00e042c6-76ad-423c-a8d6-d6f7f5b083af_c5e941b6-1b39-4a80-93c2-af6d82bbf72e.html,,,,,, "Slags, ferrochromium-manufg.",69012-27-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5029c78-62cf-4096-9ba8-99f795f65911/documents/IUC5-00e042c6-76ad-423c-a8d6-d6f7f5b083af_c5e941b6-1b39-4a80-93c2-af6d82bbf72e.html,,oral,LD50,"5,000 mg/kg bw",, "Slags, ferrochromium-manufg.",69012-27-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5029c78-62cf-4096-9ba8-99f795f65911/documents/IUC5-00e042c6-76ad-423c-a8d6-d6f7f5b083af_c5e941b6-1b39-4a80-93c2-af6d82bbf72e.html,,dermal,LD50,"5,000 mg/kg bw",, "Slags, ferrochromium-manufg.",69012-27-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a5029c78-62cf-4096-9ba8-99f795f65911/documents/IUC5-00e042c6-76ad-423c-a8d6-d6f7f5b083af_c5e941b6-1b39-4a80-93c2-af6d82bbf72e.html,,inhalation,LC50,"2,000 mg/m3",, "Slags, ferromanganese-manufg.",69012-28-8," Key Study: Ferroatlantica (2016) - SiMn slag Oral (gavage) administration of the read-across substance SiMn slag to Sprague-Dawley rats at doses up to 1000 mg/kg/day for 13 weeks did not cause any evidence of systemic toxicity, including neurotoxicity. The no-observed-adverse-effect level (NOAEL) for systemic toxicity in this study was considered to be 1000 mg/kg/day. Supporting Study: NTP (1993) - MnSO4 The NOAEL for male rats exposed to MnSO4 was 1700 mg/kg/day. The NOAEL for female rats was 2000 mg/kg/day. Supporting Study: Cooper (2019) Oral (gavage) administration of the registered substance to Sprague Dawley rats at doses up to 1000 mg/kg bw/day for 7 weeks caused no treatment-related clinical signs, no unscheduled deaths and no effect on bodyweight and food consumption. The no-observed-adverse-effect level (NOAEL) for systemic toxicity in this study was considered to be 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/597743bf-5f53-4d13-8144-21e6a6da3748/documents/76f2d1ad-cf50-4c23-9919-15028da6a37c_0dd78e11-af3b-45e2-8fb2-a2c87e97d5f8.html,,,,,, "Slags, ferromanganese-manufg.",69012-28-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/597743bf-5f53-4d13-8144-21e6a6da3748/documents/76f2d1ad-cf50-4c23-9919-15028da6a37c_0dd78e11-af3b-45e2-8fb2-a2c87e97d5f8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Slags, ferromanganese-manufg.",69012-28-8,"ORALLD50 > 2000 mg/kg bw, rat (female), OECD 420, EU Method B.1 bis, Pooles (2009)DERMALLD50 > 2000 mg/kg bw, rat (male/female), EU Method B.3, Ferroatlantica (2003) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/597743bf-5f53-4d13-8144-21e6a6da3748/documents/IUC5-3a1fb270-7d8e-4326-9943-a7a38d838723_0dd78e11-af3b-45e2-8fb2-a2c87e97d5f8.html,,,,,, "Slags, ferromanganese-manufg.",69012-28-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/597743bf-5f53-4d13-8144-21e6a6da3748/documents/IUC5-3a1fb270-7d8e-4326-9943-a7a38d838723_0dd78e11-af3b-45e2-8fb2-a2c87e97d5f8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Slags, ferromanganese-manufg.",69012-28-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/597743bf-5f53-4d13-8144-21e6a6da3748/documents/IUC5-3a1fb270-7d8e-4326-9943-a7a38d838723_0dd78e11-af3b-45e2-8fb2-a2c87e97d5f8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Slags, ferromolybdenum-manufg., silicothermic",84144-95-6,"NOAEL for systemic toxicity, oral, from a sub-chronic study with sodium molybdate dihydrate in rats (Hoffman, 2011): 17 mg Mo/kg bw/day. Unbounded NOAEC for systemic toxicity, inhalation, from a sub-chronic study with molybdenum trioxide in rats and mice (NTP, 1997): 66.7 mg Mo/m³. Important: both values expressed based on element Mo (for read-across purposes), not on the respective test substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/671f83c8-215c-46e2-b6ce-4e062dcda1a3/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_e8bac5dc-8e03-48d0-9e7e-57a8f5ac1d25.html,,,,,, "Slags, ferromolybdenum-manufg., silicothermic",84144-95-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/671f83c8-215c-46e2-b6ce-4e062dcda1a3/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_e8bac5dc-8e03-48d0-9e7e-57a8f5ac1d25.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat "Slags, ferromolybdenum-manufg., silicothermic",84144-95-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/671f83c8-215c-46e2-b6ce-4e062dcda1a3/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_e8bac5dc-8e03-48d0-9e7e-57a8f5ac1d25.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,66.7 mg/m3,,other:rats and mice "Slags, ferromolybdenum-manufg., silicothermic",84144-95-6," To avoid unnecessary (animal) testing, a comprehensive grouping and read-across concept has been developed amongst several molybdenum containing substances. Acute oral, inhalation and dermal toxicity studies are available for several but not all substances in the category. The following LD50s are therefore either based on test data for the substance in this dossier, or based on read-across within the category: For FeMo slags: LD50 oral: > 2000 mg/kg  (estimated, based on category read-across) LD50 inhalation, 4h: > 5 g/m³ (estimated, based on category read-across) LD50 dermal: > 2000 mg/kg (estimated, based on category read-across) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/671f83c8-215c-46e2-b6ce-4e062dcda1a3/documents/IUC5-29ea640f-7045-450f-96d4-1db3ef337cee_e8bac5dc-8e03-48d0-9e7e-57a8f5ac1d25.html,,,,,, "Slags, ferronickel-manufg.",69012-29-9,"Chronic dermal and chronic oral toxicity are not considered relevant in the case of ferronickel slags.Additionally, no toxicity effects were observed on an in vivo acute skin irritation test (see relevant endpoint), while the low solubility of the constituents and the absence of dermal toxicity effects for the degradation products show no need for the test.Repeated oral exposure is not relevant under the given industrial settings of production and uses of Ferronickel Slags and the RMM that are applied.The workers dine away from the areas where slag is being processed and work with personal protective equipment.No studies on adverse toxicological effects through chronic inhalation exposure to ferronickel slags are known to exist.In order to avoid testing on live animals it was decided to assess the chronic inhalation toxicity potential of the slags based on the toxicological profile of the individual constituents, supplemented by data collected from findings of toxicological tests performed on the substance.Overall the data on inhalation toxicity are sufficient and allow for robust risk characterization of ferronickel slags.The only considerable hazard is attributed to the contained Nickel metal, which was found to produce toxic effects on the lungs in the form of fine nickel dust. However, the low content of both slags in Nickel metal, the coarseness of the substance's granulometry, Nickel's non-existent solubility (endpoint 4.8) and it being chemically bound in the slag matrix can lead to the cocnlusion that no adverse effects are expected from the substance. The rest of the constituents do not present a chronic hazard.A NOAEC of 0.1mg/m3 was identified for Nickel metal which translates to at least 25mg/m3 for ferronickel slag (with the worst case scenario of 0.4% Ni content).This is a strict result, because ferronickel slags are much more coarse than the tested material (only 10% of the inhalable fraction, which itself is only 6% of total dust, are below 5μm) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3b45510-5fff-440e-82c1-9e30e35e274c/documents/IUC5-2f845697-b2e4-4342-8326-39066c9d2f25_65996946-d565-4c2b-83ca-12c7b3fb5008.html,,,,,, "Slags, ferronickel-manufg.",69012-29-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3b45510-5fff-440e-82c1-9e30e35e274c/documents/IUC5-2f845697-b2e4-4342-8326-39066c9d2f25_65996946-d565-4c2b-83ca-12c7b3fb5008.html,Chronic toxicity – systemic effects,inhalation,LOAEC,25 mg/m3,,rat "Slags, ferronickel-manufg.",69012-29-9,"Slags, ferronickel-manufg is not expected to be absorbed via the gastrointestinal tract after oral administration. This is inferred by the study of acute toxicity via oral route (conducted as limit test) where no sign of systemic toxicity was found at a dose of 2000mg/kg bw. Acute toxicity via inhalation route also showed no adverse effect in a nominal atmosphere containing 5.16 mg/m3. Studies on dermal exposure were disregarded since dermal contact in the production and/or use is unlikely and inhalation is likely ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3b45510-5fff-440e-82c1-9e30e35e274c/documents/IUC5-7bc5f862-33bb-4e34-9a1b-d41a018b6950_65996946-d565-4c2b-83ca-12c7b3fb5008.html,,,,,, "Slags, ferrous metal, blast furnace",65996-69-2," The most likely exposure pathway to humans is inhalation of the dust of fine-grained ferrous slag. Dermal and oral repeated exposure is insignificant and consider as not critical and or not relevant for the users/human, based on expected uses. GGBS is considered to cover the worst-case of ferrous slag, because it is intentionally ground for the cement industry and thus contains by far the highest amount of fine and inhalable particles compared to other types of ferrous slag. From single-dose toxicity testing in animals via the oral, dermal and inhalation routes it can be concluded that ferrous slags are not acutely toxic. A acute 4 -week inhalation toxicity study in rats by GGBS conducted by Bayer Healthcare 2012, concentration-and-time-related onset of lung changes were monitored up to 90 days after a single short-term exposure to GGBS. The findings showed no likely acute inhalation hazard, based on the limit test data (LC50 > 5235 mg GGBS/m³), and ferrous slags can be expected to be virtually non-toxic after inhalation exposure. A short-term study (28 days) to repeated inhalation exposure to GGBS in rats up to 24 ug/L, was done by Charles River Laboratories, 2015. There were no death or adverse clinical signs during the study period and no evidence of lung injury could observed. Based on the result in this study, the NOAEL was determined to 24 ug/L (target concentration) or 24.9 ug/L (achieved concentration). The aim of the studies was to provide information on health hazards likely to arise from short-term or long-term exposure to ferrous slags by the inhalation route. A sub-chronic toxicity study (90 days) for inhalation does not need to be conducted because the substance (slags) is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28 day short-term study and human exposure is limited. A short term-toxicity study by the oral and or dermal route does not need to be conducted because an appropriate inhalation study is available and inhalation is the most appropriate route of administration as based on the expected uses, exposure assessment and the chemical- and physico properties of the slags. The substance is a solid at room temperature and no or very little dust (below the work place limit value for inhalable dust of 10 mg/m³ and for respiratory dust of 3 mg/m³ which applies for inert dust in some of the European countries) is formed for the intended uses. The work place limit values are routineously monitored in all relevant workplaces were a significant exposure to slag dust may occur. Uptake of fine slag dust into the lungs does not significantly affect the levels of trace metals in the lung associated lymph nodes. The half live of slag dust in the lungs is approximately 60 d suggesting that slags are inert dust without hazardous effect on the respiration system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/02053cf2-4d8f-411f-a7db-0fb9401dfef6/documents/8c89f3cc-d191-42ee-aece-0fd3e7436567_f6bad344-bf7a-4d62-9392-4ae542e61780.html,,,,,, "Slags, ferrous metal, blast furnace",65996-69-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/02053cf2-4d8f-411f-a7db-0fb9401dfef6/documents/8c89f3cc-d191-42ee-aece-0fd3e7436567_f6bad344-bf7a-4d62-9392-4ae542e61780.html,Repeated dose toxicity – local effects,inhalation,NOAEC,24.9 mg/m3,no adverse effect observed,rat "Slags, ferrous metal, blast furnace",65996-69-2,"No acute toxicity of any slagBasis for this conclusionOralABS, GBS, EAF C: OECD TG 401, rats: LD50 > 2000 mg/kg bwBOS, SMS: OECD TG 423, rats: LD50 > 2000 mg/kg bwInhalationGGBS: OECD 403, rats: 4 h-LC50 >5235 mg/m3SkinBOS, SMS: rats OECD 402, rats: LD50 > 4000 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02053cf2-4d8f-411f-a7db-0fb9401dfef6/documents/ac1f92e1-ff5a-49b5-8be3-13de32b403f4_f6bad344-bf7a-4d62-9392-4ae542e61780.html,,,,,, "Slags, ferrous metal, blast furnace",65996-69-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02053cf2-4d8f-411f-a7db-0fb9401dfef6/documents/ac1f92e1-ff5a-49b5-8be3-13de32b403f4_f6bad344-bf7a-4d62-9392-4ae542e61780.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Slags, ferrous metal, blast furnace",65996-69-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02053cf2-4d8f-411f-a7db-0fb9401dfef6/documents/ac1f92e1-ff5a-49b5-8be3-13de32b403f4_f6bad344-bf7a-4d62-9392-4ae542e61780.html,,dermal,LD50,"4,000 mg/kg bw",no adverse effect observed, "Slags, ferrous metal, blast furnace",65996-69-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02053cf2-4d8f-411f-a7db-0fb9401dfef6/documents/ac1f92e1-ff5a-49b5-8be3-13de32b403f4_f6bad344-bf7a-4d62-9392-4ae542e61780.html,,inhalation,LC50,"5,235 mg/m3",no adverse effect observed, "Slags, ilmenite electrothermal smelting",91081-64-0,"Acute oral toxicity testing was performed with UGI Exxaro sulphate slag, since this test material was chosen as representative material based on particle size distribution (smallest particle size as reported under section particle size distribution (Weidenfeller 2007) and in vitro bioavailablity/bioaccessibility testing (highest bioelution pattern as reported under section basic toxicokinetics). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a69fb478-970f-46cb-a3c6-aa12855a62f6/documents/IUC5-364b6e0c-b2e0-4e91-ab6c-9f52c9a7c92d_5c5a014b-a6a8-4d30-82f5-111a496020bc.html,,,,,, "Slags, ilmenite electrothermal smelting",91081-64-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a69fb478-970f-46cb-a3c6-aa12855a62f6/documents/IUC5-364b6e0c-b2e0-4e91-ab6c-9f52c9a7c92d_5c5a014b-a6a8-4d30-82f5-111a496020bc.html,,oral,LD50,"2,000 mg/kg bw",, "Slags, lead reverbatory smelting",69029-58-9, Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents.  Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b5ea7adf-25bf-4201-9376-38c22b4233ef/documents/IUC5-b52c4ad4-c153-4014-90d6-5d5acfc84786_e24fb89f-af78-4102-a731-b50ebeeb5ca6.html,,,,,, "Slags, lead reverbatory smelting",69029-58-9, The acute toxicity is driven by the characteristics of the individual UVCB constituents.  Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5ea7adf-25bf-4201-9376-38c22b4233ef/documents/IUC5-e00444ee-5c77-496d-b7b7-94a1e87fb375_e24fb89f-af78-4102-a731-b50ebeeb5ca6.html,,,,,, "Slags, lead smelting",69029-84-1,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aeaf4426-cbbd-480f-86a4-5c535410d8d8/documents/IUC5-ad630210-baea-4073-a5d2-f1b1d477e233_9c579f72-7760-4694-bc73-b686c7ef5cd1.html,,,,,, "Slags, lead smelting",69029-84-1,The acute toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aeaf4426-cbbd-480f-86a4-5c535410d8d8/documents/IUC5-e928bde2-d54e-442a-aae3-468a793b5709_9c579f72-7760-4694-bc73-b686c7ef5cd1.html,,,,,, "Slags, lead-zinc smelting",93763-87-2,"Non-human informationThe repeated dose toxicity of water soluble zinc sulphate and zinc monoglycerolate has been examined in a total of 3 subchronic oral feeding studies. Due to the different dosing regimens, the lowest NOAEL was determined to be 31.5 mg/kg bw/day of zinc monoglycerolate which equals a total zinc exposure of approximate 13 mg/kg bw/day. The zinc NOAEL derived from the feeding studies with zinc sulphate was determined to be 104 mg Zn/kg bw/day in mice and approximately 53.5 mg/kg bw/day in rats. At higher doses the most important effects in the rats were the development of hypocupremia, and significant changes in the pancreas (i.e., focal acinar degeneration and necrosis) and a decreased number of pigmented macrophages in spleen.No longer term inhalation studies allowing to derive a robust NOEL for the inhalatory exposure of the respective zinc compounds has been identified. In a short term 3-day inhalation study with guinea pigs, a concentration of 2.3 mg ultrafine ZnO/m3 (3 hours/day) resulted in changes in neutrophils and activities of lactate dehydrogenase and alkaline phosphatase in the pulmonary fluid. At higher concentrations increased protein concentration, neutrophils, and enzyme activities in lung lavage fluids were seen, together with significant centriacinar inflammation of the pulmonary tissue. Inhalatory doses of 2.7 mg ultrafine ZnO/m3 for 5 days 3hours/day did not alter the lung function parameters in guinea pigs, but at 5 and 7 mg ultrafine ZnO/m3 exposure according to a similar pattern, a gradual decrease in total lung capacity, vital capacity and reduction of the carbon monoxide diffusing capacity was seen in combination with inflammatory changes and edema. The relevance of the findings in studies with ultra-fine zinc oxide fumes is unclear with respect to commercial grade zinc oxide, as the latter is of much larger particle size and can have different toxicological characteristics. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e019e98-528d-4ff1-8212-61e2aa4f70cc/documents/IUC5-748c324f-1a27-4e79-babd-deee5fe2058a_a08bd826-09cf-41cd-afdc-e13a69b254b4.html,,,,,, "Slags, lead-zinc smelting",93763-87-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e019e98-528d-4ff1-8212-61e2aa4f70cc/documents/IUC5-748c324f-1a27-4e79-babd-deee5fe2058a_a08bd826-09cf-41cd-afdc-e13a69b254b4.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,2.7 mg/m3,,guinea pig "Slags, lead-zinc smelting",93763-87-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5e019e98-528d-4ff1-8212-61e2aa4f70cc/documents/IUC5-748c324f-1a27-4e79-babd-deee5fe2058a_a08bd826-09cf-41cd-afdc-e13a69b254b4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,13.3 mg/kg bw/day,,rat "Slags, lead-zinc smelting",93763-87-2,"The slightly soluble and insoluble zinc compounds (i.e., zinc oxide, zinc hydroxide, zinc phosphate, zinc carbonate, zinc metal and zinc sulphide) are of low acute, dermal and inhalation toxicity not requiring a classification for acute toxicity according to the EC criteria. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e019e98-528d-4ff1-8212-61e2aa4f70cc/documents/IUC5-fd398840-49e5-4d51-a054-137193a40ecf_a08bd826-09cf-41cd-afdc-e13a69b254b4.html,,,,,, "Slags, lead-zinc smelting",93763-87-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e019e98-528d-4ff1-8212-61e2aa4f70cc/documents/IUC5-fd398840-49e5-4d51-a054-137193a40ecf_a08bd826-09cf-41cd-afdc-e13a69b254b4.html,,oral,LD50,"2,000 mg/kg bw",, "Slags, lead-zinc smelting",93763-87-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e019e98-528d-4ff1-8212-61e2aa4f70cc/documents/IUC5-fd398840-49e5-4d51-a054-137193a40ecf_a08bd826-09cf-41cd-afdc-e13a69b254b4.html,,dermal,LD50,"2,000 mg/kg bw",, "Slags, lead-zinc smelting",93763-87-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5e019e98-528d-4ff1-8212-61e2aa4f70cc/documents/IUC5-fd398840-49e5-4d51-a054-137193a40ecf_a08bd826-09cf-41cd-afdc-e13a69b254b4.html,,inhalation,LC50,5.41 mg/m3,, "Slags, precious metal refining",98072-60-7,"No information on animal testing of ""Slags, precious metal"" refining is available. However, ""Slags, precious metal refining"" contained lead compounds, nickel oxide and crystalline respirable silica with concentration relevant for STOT RE classification of mixture. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/26c3301e-8f7c-48c8-9190-f4be1ef91876/documents/IUC5-0a790735-654a-4804-909c-099e7309f532_4afde274-e990-47d5-badf-07be2900652a.html,,,,,, "Slags, precious metal refining",98072-60-7,"No information on animal testing of “Slags, precious metal refining” on acute toxicity is available. The C&L for acute toxicity of “Slags, precious metal refining” - composition profile 2 was determined by using the “acute toxicity range estimate (ATE)” and respective rules of Regulation (EC) 1272/2006 section 3.1.3.6 “Classification of mixtures based on ingredients of the mixture”. Furthermore, for specific target organ toxicity – single exposure the generic concentration limit of 20 % for STOT SE Cat. 3 classification was used. Applying these rules, “Slags, precious metal refining” - composition profile 2 meets classification criteria as specific target organ toxicant via single inhalation exposure but is not acutely toxic via ingestion, inhalation and by skin contact. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26c3301e-8f7c-48c8-9190-f4be1ef91876/documents/IUC5-caa79e01-fb0e-47d3-97ea-5e21cef7bff4_4afde274-e990-47d5-badf-07be2900652a.html,,,,,, "Slags, precious metal refining",98072-60-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26c3301e-8f7c-48c8-9190-f4be1ef91876/documents/IUC5-caa79e01-fb0e-47d3-97ea-5e21cef7bff4_4afde274-e990-47d5-badf-07be2900652a.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Slags, precious metal refining",98072-60-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26c3301e-8f7c-48c8-9190-f4be1ef91876/documents/IUC5-caa79e01-fb0e-47d3-97ea-5e21cef7bff4_4afde274-e990-47d5-badf-07be2900652a.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Slags, precious metal refining",98072-60-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/26c3301e-8f7c-48c8-9190-f4be1ef91876/documents/IUC5-caa79e01-fb0e-47d3-97ea-5e21cef7bff4_4afde274-e990-47d5-badf-07be2900652a.html,,inhalation,discriminating conc.,"5,000 mg/m3",no adverse effect observed, "Slags, silicomanganese-manufg.",69012-33-5," It was concluded that oral (gavage) administration of the granulated test material to Sprague-Dawley rats at doses up to 1000 mg/kg/day for 13 weeks did not cause any evidence of systemic toxicity, including neurotoxicity. The no-observed-adverse-effect level (NOAEL) for systemic toxicity in this study was considered to be 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f89f63a7-00d3-4784-90e7-446480a6b5c1/documents/e100b1af-118d-4c26-9e5b-433d50561302_f50f5b68-255d-4737-b514-3e186cd5e1bd.html,,,,,, "Slags, silicomanganese-manufg.",69012-33-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f89f63a7-00d3-4784-90e7-446480a6b5c1/documents/e100b1af-118d-4c26-9e5b-433d50561302_f50f5b68-255d-4737-b514-3e186cd5e1bd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Slags, silicomanganese-manufg.",69012-33-5,"ORALLD50 > 2000 mg/kg bw, rat (male/female), EU Method B.1, Ferroatlantica (2003)DERMALLD50 > 2000 mg/kg bw, rat (male/female), EU Method B.3, Ferroatlantica (2003) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f89f63a7-00d3-4784-90e7-446480a6b5c1/documents/IUC5-de8cf4f4-3848-4c0f-870d-e1140c62852e_f50f5b68-255d-4737-b514-3e186cd5e1bd.html,,,,,, "Slags, steelmaking",65996-71-6," The most likely exposure pathway to humans is inhalation of the dust of fine-grained ferrous slag. Dermal and oral repeated exposure is insignificant and consider as not critical and or not relevant for the users/human, based on expected uses. GGBS is considered to cover the worst-case of ferrous slag, because it is intentionally ground for the cement industry and thus contains by far the highest amount of fine and inhalable particles compared to other types of ferrous slag. From single-dose toxicity testing in animals via the oral, dermal and inhalation routes it can be concluded that ferrous slags are not acutely toxic. A acute 4 -week inhalation toxicity study in rats by GGBS conducted by Bayer Healthcare 2012, concentration-and-time-related onset of lung changes were monitored up to 90 days after a single short-term exposure to GGBS. The findings showed no likely acute inhalation hazard, based on the limit test data (LC50 > 5235 mg GGBS/m³), and ferrous slags can be expected to be virtually non-toxic after inhalation exposure. A short-term study (28 days) to repeated inhalation exposure to GGBS in rats up to 24 ug/L, was done by Charles River Laboratories, 2015. There were no death or adverse clinical signs during the study period and no evidence of lung injury could observed. Based on the result in this study, the NOAEL was determined to 24 ug/L (target concentration) or 24.9 ug/L (achieved concentration). The aim of the studies was to provide information on health hazards likely to arise from short-term or long-term exposure to ferrous slags by the inhalation route. A sub-chronic toxicity study (90 days) for inhalation does not need to be conducted because the substance (slags) is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28 day short-term study and human exposure is limited. A short term-toxicity study by the oral and or dermal route does not need to be conducted because an appropriate inhalation study is available and inhalation is the most appropriate route of administration as based on the expected uses, exposure assessment and the chemical- and physico properties of the slags. The substance is a solid at room temperature and no or very little dust (below the work place limit value for inhalable dust of 10 mg/m³ and for respiratory dust of 3 mg/m³ which applies for inert dust in some of the European countries) is formed for the intended uses. The work place limit values are routineously monitored in all relevant workplaces were a significant exposure to slag dust may occur. Uptake of fine slag dust into the lungs does not significantly affect the levels of trace metals in the lung associated lymph nodes. The half live of slag dust in the lungs is approximately 60 d suggesting that slags are inert dust without hazardous effect on the respiration system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ab9c963-f08f-4c22-aec2-40473705411b/documents/d07def58-cbac-4d0b-af58-8225b94d4ac2_6077f52e-7f30-498d-9bfd-4a65355ece22.html,,,,,, "Slags, steelmaking",65996-71-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ab9c963-f08f-4c22-aec2-40473705411b/documents/d07def58-cbac-4d0b-af58-8225b94d4ac2_6077f52e-7f30-498d-9bfd-4a65355ece22.html,Repeated dose toxicity – local effects,inhalation,NOAEC,24.9 mg/m3,no adverse effect observed,rat "Slags, steelmaking",65996-71-6,"No acute toxicity of any slagBasis for this conclusionOralABS, GBS, EAF C: OECD TG 401, rats: LD50 > 2000 mg/kg bwBOS, SMS: OECD TG 423, rats: LD50 > 2000 mg/kg bwInhalationGGBS: OECD 403, rats: 4 h-LC50 >5235 mg/m3SkinBOS, SMS: rats OECD 402, rats: LD50 > 4000 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ab9c963-f08f-4c22-aec2-40473705411b/documents/c58f6d6c-04b2-466e-bef4-f8475df88b87_6077f52e-7f30-498d-9bfd-4a65355ece22.html,,,,,, "Slags, steelmaking",65996-71-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ab9c963-f08f-4c22-aec2-40473705411b/documents/c58f6d6c-04b2-466e-bef4-f8475df88b87_6077f52e-7f30-498d-9bfd-4a65355ece22.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Slags, steelmaking",65996-71-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ab9c963-f08f-4c22-aec2-40473705411b/documents/c58f6d6c-04b2-466e-bef4-f8475df88b87_6077f52e-7f30-498d-9bfd-4a65355ece22.html,,dermal,LD50,"4,000 mg/kg bw",no adverse effect observed, "Slags, steelmaking",65996-71-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ab9c963-f08f-4c22-aec2-40473705411b/documents/c58f6d6c-04b2-466e-bef4-f8475df88b87_6077f52e-7f30-498d-9bfd-4a65355ece22.html,,inhalation,LC50,"5,235 mg/m3",no adverse effect observed, "Slags, steelmaking, converter",91722-09-7," The most likely exposure pathway to humans is inhalation of the dust of fine-grained ferrous slag. Dermal and oral repeated exposure is insignificant and consider as not critical and or not relevant for the users/human, based on expected uses. GGBS is considered to cover the worst-case of ferrous slag, because it is intentionally ground for the cement industry and thus contains by far the highest amount of fine and inhalable particles compared to other types of ferrous slag. From single-dose toxicity testing in animals via the oral, dermal and inhalation routes it can be concluded that ferrous slags are not acutely toxic. A acute 4 -week inhalation toxicity study in rats by GGBS conducted by Bayer Healthcare 2012, concentration-and-time-related onset of lung changes were monitored up to 90 days after a single short-term exposure to GGBS. The findings showed no likely acute inhalation hazard, based on the limit test data (LC50 > 5235 mg GGBS/m³), and ferrous slags can be expected to be virtually non-toxic after inhalation exposure. A short-term study (28 days) to repeated inhalation exposure to GGBS in rats up to 24 ug/L, was done by Charles River Laboratories, 2015. There were no death or adverse clinical signs during the study period and no evidence of lung injury could observed. Based on the result in this study, the NOAEL was determined to 24 ug/L (target concentration) or 24.9 ug/L (achieved concentration). The aim of the studies was to provide information on health hazards likely to arise from short-term or long-term exposure to ferrous slags by the inhalation route. A sub-chronic toxicity study (90 days) for inhalation does not need to be conducted because the substance (slags) is unreactive, insoluble and not inhalable and there is no evidence of absorption and no evidence of toxicity in a 28 day short-term study and human exposure is limited. A short term-toxicity study by the oral and or dermal route does not need to be conducted because an appropriate inhalation study is available and inhalation is the most appropriate route of administration as based on the expected uses, exposure assessment and the chemical- and physico properties of the slags. The substance is a solid at room temperature and no or very little dust (below the work place limit value for inhalable dust of 10 mg/m³ and for respiratory dust of 3 mg/m³ which applies for inert dust in some of the European countries) is formed for the intended uses. The work place limit values are routineously monitored in all relevant workplaces were a significant exposure to slag dust may occur. Uptake of fine slag dust into the lungs does not significantly affect the levels of trace metals in the lung associated lymph nodes. The half live of slag dust in the lungs is approximately 60 d suggesting that slags are inert dust without hazardous effect on the respiration system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73271b53-931c-4e9f-99d4-a96c417d483f/documents/f120f3ff-2cdb-4536-8f4a-3a8c79aec636_185408bd-921a-4465-8a64-ba5fb2a52475.html,,,,,, "Slags, steelmaking, converter",91722-09-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73271b53-931c-4e9f-99d4-a96c417d483f/documents/f120f3ff-2cdb-4536-8f4a-3a8c79aec636_185408bd-921a-4465-8a64-ba5fb2a52475.html,Repeated dose toxicity – local effects,inhalation,NOAEC,24.9 mg/m3,no adverse effect observed,rat "Slags, steelmaking, converter",91722-09-7,"No acute toxicity of any slagBasis for this conclusionOralABS, GBS, EAF C: OECD TG 401, rats: LD50 > 2000 mg/kg bwBOS, SMS: OECD TG 423, rats: LD50 > 2000 mg/kg bwInhalationGGBS: OECD 403, rats: 4 h-LC50 >5235 mg/m3SkinBOS, SMS: rats OECD 402, rats: LD50 > 4000 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73271b53-931c-4e9f-99d4-a96c417d483f/documents/2a5f45ff-a24a-49ed-9a02-fccbeab7bc37_185408bd-921a-4465-8a64-ba5fb2a52475.html,,,,,, "Slags, steelmaking, converter",91722-09-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73271b53-931c-4e9f-99d4-a96c417d483f/documents/2a5f45ff-a24a-49ed-9a02-fccbeab7bc37_185408bd-921a-4465-8a64-ba5fb2a52475.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Slags, steelmaking, converter",91722-09-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73271b53-931c-4e9f-99d4-a96c417d483f/documents/2a5f45ff-a24a-49ed-9a02-fccbeab7bc37_185408bd-921a-4465-8a64-ba5fb2a52475.html,,dermal,LD50,"4,000 mg/kg bw",no adverse effect observed, "Slags, steelmaking, converter",91722-09-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73271b53-931c-4e9f-99d4-a96c417d483f/documents/2a5f45ff-a24a-49ed-9a02-fccbeab7bc37_185408bd-921a-4465-8a64-ba5fb2a52475.html,,inhalation,LC50,"5,235 mg/m3",no adverse effect observed, "Slags, steelmaking, vanadium",69012-34-6,"Studies via the oral and inhalation route are not available for slags, steelmaking, vanadium, but for other vanadium substances. The rationale for read-across to slags, steelmaking, vanadium including the limitations thereof is summarised below (see discussion). Of the limited effects noted following oral exposure of soluble vanadium substances, it appears most likely that effects on haematological parameters are the most consistently reported among a number of investigators.Information on repeated dose toxicity following inhalation exposure to V2O5 is available in a NTP study (k_NTP 2002) with exposure of male and female rats and mice to V2O5 over 16-days, 3-months and 2-years. Pulmonary reactivity to vanadium pentoxide was also investigated following subchronic inhalation exposure in a non-human primate animal model. However, local effects on the respiratory tract are not considered relevant for slags, steelmaking, vanadium. In a 14-d repeated-dose inhalation toxicity study, Sprague-Dawley rats were exposed to micronised vanadium trioxide powder via nose-only inhalation.Test-substance related mortality or any clinical signs of systemic toxicity were not observed at any exposure level. Body weights/body weight gain and food consumption were significantly decreased only at the highest exposure (0.25 mg/L) in males and females. In summary, based on the local effects in the respiratory tract of the test animals at the high exposure level (0.25 mg/L), the NOAEC was 0.02 mg/L (20 mg/m3). All effects on BAL parameters, lung weights and lung histopathology seen at the lower exposure levels were considered as adaptive responses to divanadium trioxide exposure, rather than an indication of local toxicity. This NOAEC translates into 6.8 mg V/m3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac25ab19-4cc7-4cd8-a86c-0e7f10f75b54/documents/IUC5-754800d1-9e5a-4b32-8815-815ba8847d3a_e5daae3a-25a0-497a-8206-100344e41a0c.html,,,,,, "Slags, steelmaking, vanadium",69012-34-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac25ab19-4cc7-4cd8-a86c-0e7f10f75b54/documents/IUC5-754800d1-9e5a-4b32-8815-815ba8847d3a_e5daae3a-25a0-497a-8206-100344e41a0c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,6.8 mg/m3,no adverse effect observed,rat "Slags, steelmaking, vanadium",69012-34-6,"Slags, steelmaking, vanadium is non-toxic if swallowed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac25ab19-4cc7-4cd8-a86c-0e7f10f75b54/documents/IUC5-40cd03aa-a0d0-4f6d-97b2-99c25f4ec661_e5daae3a-25a0-497a-8206-100344e41a0c.html,,,,,, "Slimes and Sludges, battery scrap, antimony- and lead-rich",102110-60-1,"Complex substance containing metals. The classification is based on assessment of the components, treating it as a mixture.Considered to be harmful if ingested and inhaled. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4357a8e4-0caf-4793-b2f0-a1b875418fa6/documents/IUC5-216a181a-504c-4129-97e5-b097b41c05d7_5a5f89e1-6c1f-406e-89fa-b7dec16d257e.html,,,,,, "Slimes and Sludges, blast furnace and steelmaking",65996-73-8," The test substance, Slimes and Sludges, blast furnace and steelmaking, was tested for sub-acute toxicity using the EU method B.7. Repeated Dose (28-days) Toxicity (Oral); the test was performed according to GLP rules. No mortality was observed in the study. No toxicologically relevant clinical sign was recorded during the study. Several deviations of various parameters were recorded, with and without dose-dependent (e.g. decreased total erythrocyte count or decreased value of creatinine). These changes were evaluated as statistically significant but within the historical control range. These effects were considered non-adverse. Significant microscopic findings were found in stomach of treated males and females. Infiltration of mucosa and submucosa was recorded in males of all treated groups but markedly at the highest dose level and in females only at the highest dose level. Some changes were recorded at the end of recovery period. The 90-d repeated dose inhalation toxicity test was performed in accordance with OECD TG 413 and according to GLP principles. The exposure to Slimes and Sludges, blast furnace and steelmaking to experimental rats for 90 days for 6 hours/day on a 5 day per week did not cause any clinical sign at dose levels 0.03 to 0.3 mg/L. There were no statistically significant adverse effects on body weight, food consumption, ophthalmology, clinical pathology or oestrus cycle. There was a minimal, but statistically significant test substance related effects on terminal body weight. The lung weights were increased and the thymus weights were decreased in the test substance exposed animals in a dose dependent manner and correlated with histopathological findings in both organs. In histopathology, test item-related changes were seen in the lung, in the nasal cavity and in the mediastinal lymph nodes at all dose levels. A higher incidence and severity of reduced size of thymus was observed. The histopathology changes were considered non-adverse, adaptive changes. These test substance related changes were considered as non-adverse. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4779de71-0911-4822-bd4d-f071dde526db/documents/IUC5-702da3a3-ce56-4877-81fb-fb7f1fc9560b_9232a88e-bdca-4b7c-9d76-8f3b5d96cd9e.html,,,,,, "Slimes and Sludges, blast furnace and steelmaking",65996-73-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4779de71-0911-4822-bd4d-f071dde526db/documents/IUC5-702da3a3-ce56-4877-81fb-fb7f1fc9560b_9232a88e-bdca-4b7c-9d76-8f3b5d96cd9e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat "Slimes and Sludges, blast furnace and steelmaking",65996-73-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4779de71-0911-4822-bd4d-f071dde526db/documents/IUC5-702da3a3-ce56-4877-81fb-fb7f1fc9560b_9232a88e-bdca-4b7c-9d76-8f3b5d96cd9e.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,300 mg/m3,,rat "Slimes and Sludges, blast furnace and steelmaking",65996-73-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4779de71-0911-4822-bd4d-f071dde526db/documents/IUC5-702da3a3-ce56-4877-81fb-fb7f1fc9560b_9232a88e-bdca-4b7c-9d76-8f3b5d96cd9e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,300 mg/m3,no adverse effect observed,rat "Slimes and Sludges, blast furnace and steelmaking",65996-73-8,"The testing of acute oral toxicity was performed according to the Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008. The test substance wasadministered in a single dose as suspension in vehicle (olive oil), given orally via gavage to two groups of three female Wistar rats. A study was performed in accordance with the OECD Guidelines for Testing of Chemicals (2009) No. 403 “Acute Inhalation Toxicity” and was designed to comply with Method B2 (Inhalation) of Commission Regulation (EC) No. 440/2008, with the exception that only six animals (three males and three females) were utilized during the “limit test”.According to column 2 of REACH Annex VIII, section 8.5 (Acute toxicity) was not carried out the test of acute dermal toxicity (8.5.3) by reason that inhalation exposure by dust of the test material was more probable than exposure by dermal route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4779de71-0911-4822-bd4d-f071dde526db/documents/IUC5-f891c382-b0e8-4344-a092-5f2817e5d576_9232a88e-bdca-4b7c-9d76-8f3b5d96cd9e.html,,,,,, "Slimes and Sludges, blast furnace and steelmaking",65996-73-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4779de71-0911-4822-bd4d-f071dde526db/documents/IUC5-f891c382-b0e8-4344-a092-5f2817e5d576_9232a88e-bdca-4b7c-9d76-8f3b5d96cd9e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Slimes and Sludges, blast furnace and steelmaking",65996-73-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4779de71-0911-4822-bd4d-f071dde526db/documents/IUC5-f891c382-b0e8-4344-a092-5f2817e5d576_9232a88e-bdca-4b7c-9d76-8f3b5d96cd9e.html,,inhalation,LC50,5.12 mg/m3,no adverse effect observed, "Slimes and Sludges, copper electrolytic",67711-95-9,- complex metal containing substance- solubility of metal constituents - classification via mixture toxicity rules ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f9c7dbd-ce11-46b4-a639-8e8648bf49ca/documents/IUC5-62fba7ad-1ace-4c4e-9bee-fac8a531a0df_8469075c-37ba-422a-9ae9-5afa20b48398.html,,,,,, "Slimes and Sludges, copper electrolytic",67711-95-9,- complex metal containing substance- water solubility of the substance (for metal constituents)- classification based on mixture toxicity rules ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f9c7dbd-ce11-46b4-a639-8e8648bf49ca/documents/IUC5-cd93324f-1332-43b2-abab-1bf49709c8bc_8469075c-37ba-422a-9ae9-5afa20b48398.html,,,,,, "Slimes and Sludges, precious metal refining",98072-61-8,"No information on animal testing of “Slimes and Sludges, precious metal refining"" is available. “Slimes and Sludges, precious metal refining"" 3 contains ≥ 1 % nickel chloride (specific concentration limits of nickel chloride; see ""justification for classification and non-classification"" below). Hence, “Slimes and Sludges, precious metal refining"" 3 meets classification criteria for STOT RE 1 via the inhalation route.“Slimes and Sludges, precious metal refining"" 4 contains ≥ 1 % nickel chloride and ≥ 0.3 % lead and lead compounds relevant for C&L of grade 4. For all constituents there are specific concentration limits (SCLs) given for STOT RE classification (see discussion). Based on the SCLs and the specific rules for mixtures of Regulation (EC) 1272/2008 “Slimes and Sludges, precious metal refining"" 4 requires classification as STOT RE 1. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c930676-c624-464c-a5b6-633f45acd60f/documents/IUC5-c5feba1c-8fbe-49d4-bfa4-c2af97bc0740_b0e02311-4fda-4173-a3ed-b8863602ea61.html,,,,,, "Slimes and Sludges, precious metal refining",98072-61-8,"No information on animal testing of ""Slimes and Sludges, precious metal refining"" on acute toxicity is available. The C&L of ""Slimes and Sludges, precious metal refining"" - composition profile 1 was determined by using the “acute toxicity range estimate (ATE)” and respective rules of Regulation (EC) 1272/2006 section 3.1.3.6 “Classification of mixtures based on ingredients of the mixture”. Applying these rules, ""Slimes and Sludges, precious metal refining"" - composition profile 1 does not requires classification as acutely toxic via ingestion, inhalation and after skin contact. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c930676-c624-464c-a5b6-633f45acd60f/documents/IUC5-6dfab0e2-ae20-4b24-8312-75513b19b5ee_b0e02311-4fda-4173-a3ed-b8863602ea61.html,,,,,, "Slimes and Sludges, precious metal refining",98072-61-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c930676-c624-464c-a5b6-633f45acd60f/documents/IUC5-6dfab0e2-ae20-4b24-8312-75513b19b5ee_b0e02311-4fda-4173-a3ed-b8863602ea61.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Slimes and Sludges, precious metal refining",98072-61-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c930676-c624-464c-a5b6-633f45acd60f/documents/IUC5-6dfab0e2-ae20-4b24-8312-75513b19b5ee_b0e02311-4fda-4173-a3ed-b8863602ea61.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Slimes and Sludges, precious metal refining",98072-61-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c930676-c624-464c-a5b6-633f45acd60f/documents/IUC5-6dfab0e2-ae20-4b24-8312-75513b19b5ee_b0e02311-4fda-4173-a3ed-b8863602ea61.html,,inhalation,discriminating conc.,"5,000 mg/m3",no adverse effect observed, "Slimes and Sludges, zinc sulfate electrolytic",69012-43-7,"REPEATED DOSE ORAL TOXICITY Supporting Study on Read Across Substance MnSO4 (NTP, 1993) Under the conditions of the study the NOAEL was 1 700 mg/kg bw for males and 2 000 mg/kg bw for females.   Supporting Study on Target Substance (Komura & Sakamoto (1991) Under the conditions of the study no NOAEL was identified.   REPEATED DOSE INHALATION TOXICITY Supporting Study on Read Across Substance MnCl2 (Grieve, 2017) Under the conditions of this study, the No Observed Effect Level was considered to be the target dose level 20 μg/L.   Supporting Study on Read Across Substance MnCl2 (Camner, 1985) Under the conditions of the study, no abnormalities were found in Mn(II) exposed animals, except for an increase in the size of alveolar macrophages in the high-dose group.   Supporting Study on Read Across Substance MnSO4 (Dorman, 2006) MnSO4 inhalation affected the haematology and resulted in increased Mn concentrations in the brain of the monkey.   Supporting Study on Target Substance (Rylander, 1971) In the animals exposed to MnO2, no significant changes in their particulate or bacterial clearance capacity as compared to the controls were observed.   Supporting Study on Target Substance (Rylander, 1973) Exposure to MnO2 caused a slight increase in the number of macrophages in the infection-controlled group. The number of leukocytes was increased in both types of guinea pig.   Supporting Study on Target Substance (Singh, 1977)  Histologically the lungs of most of the animals in the experimental group revealed normal structure of the pulmonary tissue with negligible amount of dust discernible. In some animals, small deposits of dusts persisted and cellular nodules composed of mononuclear cells, predominantly macrophages and thin reticulin fibres developed. The control animals did not reveal any comparable histologic change.   Supporting Study on Target Substance (Sylvestre, 1984) Under the conditions of the study, all exposed groups suffered emphysema-like tissue lesions, most severe in mice dosed with gas mixture plus MnO2.   MnO2 will be proposed for classification as STOT RE2 (H373)- target organ brain, on the basis of the Roels et al. (1992) study on battery workers - exposure is mainly to MnO2. The route of exposure in the study was inhalation and the sub-clinical effects seen at the exposure concentrations in the study, are believed to indicate that significant toxicity could occur at moderate exposure levels. On the basis of this proposal, it is considered that conducting animal testing would be both scientifically unjustified and unethical.  Therefore, in accordance with Annex XI, section 1.1 further sub-acute, sub-chronic and chronic toxicity tests are not considered necessary.   REPEATED DOSE DERMAL TOXICITY Short-term, sub-chronic and chronic toxicity studies via the dermal route do not need to be conducted as the physiological properties of the substance do not suggest a significant rate of absorption through the skin and no systemic effects or other evidence of absorption were seen in the skin or eye irritation studies (IUCLID section 7.3) and furthermore the water solubility of the substance is very poor (IUCLID section 4.8), and therefore a limited amount of potential substance is available for systemic absorption via the dermal route. Therefore, in accordance with Annex XI, section 1.1, testing via the inhalation route is not considered necessary. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/932c4fff-1c98-4ebd-8a29-f60ecbd981d6/documents/6b7cea08-9628-46b8-a866-764c19a360ce_518da986-ed5b-4776-9056-358f66e342ab.html,,,,,, "Slimes and Sludges, zinc sulfate electrolytic",69012-43-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/932c4fff-1c98-4ebd-8a29-f60ecbd981d6/documents/6b7cea08-9628-46b8-a866-764c19a360ce_518da986-ed5b-4776-9056-358f66e342ab.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,700 mg/kg bw/day",,rat "Slimes and Sludges, zinc sulfate electrolytic",69012-43-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/932c4fff-1c98-4ebd-8a29-f60ecbd981d6/documents/6b7cea08-9628-46b8-a866-764c19a360ce_518da986-ed5b-4776-9056-358f66e342ab.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,3.9 mg/m3,,rabbit "Slimes and Sludges, zinc sulfate electrolytic",69012-43-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/932c4fff-1c98-4ebd-8a29-f60ecbd981d6/documents/6b7cea08-9628-46b8-a866-764c19a360ce_518da986-ed5b-4776-9056-358f66e342ab.html,Repeated dose toxicity – local effects,inhalation,LOAEC,3.9 mg/m3,adverse effect observed, "Slimes and Sludges, zinc sulfate electrolytic",69012-43-7," Oral In accordance with Section 1 of REACH Annex XI, testing does not appear to be scientifically necessary; manganese dioxide is included in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) and is classified as acutely harmful by the oral route although there is no study available to justify this level of toxicity. Therefore, no further testing is proposed on animal welfare grounds and this classification is carried forward for risk assessment purposes.   Inhalation In accordance with Section 1 of REACH Annex XI, testing does not appear to be scientifically necessary; manganese dioxide is included in Annex VI of Regulation (EC) No 1272/2008 (CLP Regulation) and is classified as acutely harmful by the inhalation route although there is no study available to justify this level of toxicity. Therefore, no further testing is proposed on animal welfare grounds and this classification is carried forward for risk assessment purposes.   Dermal In accordance with Column 2 of REACH Annex VIII, acute toxicity testing by the dermal route is not appropriate as the physicochemical and toxicological properties do not suggest potential for a significant rate of absorption through the skin. The substance is practically insoluble in water and inorganic ions do not pass easily through the dermal barrier. In particular the high charge on the Mn4+cation would have great difficulty in penetrating the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/932c4fff-1c98-4ebd-8a29-f60ecbd981d6/documents/81ea90f1-29cd-4d9c-a123-3f0a1746b402_518da986-ed5b-4776-9056-358f66e342ab.html,,,,,, S-methyl benzo(1.2.3)thiadiazole-7-carbothioate,135158-54-2,"- Oral: NOAEL = 10 mg/kg bw/day for males and females, dogs, sub-chronic, 13 weeks, Altmann 1994a ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/239bd892-9383-4851-8aab-108dc11452f7/documents/f806a289-239b-4366-b7b5-7216c8483c6b_e6789f71-6dd9-4205-9eaf-3439f5d2d10c.html,,,,,, S-methyl benzo(1.2.3)thiadiazole-7-carbothioate,135158-54-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/239bd892-9383-4851-8aab-108dc11452f7/documents/f806a289-239b-4366-b7b5-7216c8483c6b_e6789f71-6dd9-4205-9eaf-3439f5d2d10c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,dog S-methyl benzo(1.2.3)thiadiazole-7-carbothioate,135158-54-2,"- Oral: LD50 > 5000 mg/kg bw, male/female, rat, EPA 81-1, Glaza 1995 - Inhalation: LC50 > 5000 mg/m3, male/female, rat, OECD TG 403, Hartmann 1993  - Dermal: LD50 > 2000 mg/kg bw, male/female, rat, OECD TG 402, Hartmann 1993  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/239bd892-9383-4851-8aab-108dc11452f7/documents/786cdb1e-5d76-467c-ba3d-5214eec6863f_e6789f71-6dd9-4205-9eaf-3439f5d2d10c.html,,,,,, S-methyl benzo(1.2.3)thiadiazole-7-carbothioate,135158-54-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/239bd892-9383-4851-8aab-108dc11452f7/documents/786cdb1e-5d76-467c-ba3d-5214eec6863f_e6789f71-6dd9-4205-9eaf-3439f5d2d10c.html,,oral,discriminating dose,"> 5,000 mg/kg bw",no adverse effect observed, S-methyl benzo(1.2.3)thiadiazole-7-carbothioate,135158-54-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/239bd892-9383-4851-8aab-108dc11452f7/documents/786cdb1e-5d76-467c-ba3d-5214eec6863f_e6789f71-6dd9-4205-9eaf-3439f5d2d10c.html,,dermal,discriminating dose,"> 2,000 mg/kg bw",no adverse effect observed, S-methyl benzo(1.2.3)thiadiazole-7-carbothioate,135158-54-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/239bd892-9383-4851-8aab-108dc11452f7/documents/786cdb1e-5d76-467c-ba3d-5214eec6863f_e6789f71-6dd9-4205-9eaf-3439f5d2d10c.html,,inhalation,discriminating conc.,"> 5,000 mg/m3",no adverse effect observed, "Soaps, stocks, vegetable-oil, acidulated",68952-95-4," The repeated dose toxicity potential of ‘Soaps, stocks, vegetable oil, acidulated’ can be deduced based on information available for its individual constituents. Studies conducted with the two main constituents, glycerides and fatty acids, indicate overall low toxicity. The highest free-standing NOAEL from a chronic repeated dose oral toxicity was equivalent to18.5% in diet, i.e., equivalent to 9,250 mg/kg bw/day. The sterols, sterol esters and squalene are unlikely to contribute significantly to toxicity as they were found to be poorly absorbed through oral as well as dermal routes. Tocopherols, on the other hand, were well absorbed and although beneficial at nutritionally relevant doses, may antagonise the function of other fat-soluble vitamins at higher doses. Considering the available dermal studies with some of the constituents together with their absorption potential, toxicity of the individual constituents via the dermal route is not expected to be higher than oral route. Exposure via the inhalation route is not expected considering the low vapour pressure of the substance. Further, the inhalation exposure potential in workers where the substance is handled in aerosolized or spray form is considered to be low due to implementation of strict risk management measures at workplace (See sections 9 and 10 of the CSR). Therefore, repeated dose inhalation toxicity is not expected to pose an issue for human health and no further testing is required for this endpoint, in accordance with Annex VIII, column 2 of the REACH regulation. Alternative text: Chronic and sub-chronic dietary studies were conducted in rodents with various glycerides and fatty acids which are representative of the REVODS category members and covering the fatty acid chain length of C8 to C18. In these studies, no treatment-related effects were seen in the test animals due to supplementation of the diet with these substances and consequently, the no observed effect levels for these studies were the respective highest tested dose levels. For perspective, the highest free standing NOAEL from the long term studies is 18.5% in diet from the 47-week study with coconut oil, equivalent to 9250 mg/kg bw/day (Harkins, 1968). This NOAEL is supported by free standing NOAELs from other chronic and sub-chronic studies (Morin, 1967; Nolen, 1981; Speijers, 2009; Coquet, 1977 and Manorama and Rukmini, 1991). The tocopherols, in general, contribute less to the composition of deodorizer distillates than the phytosterols and sterol esters. The sterols and sterol esters are generally poorly absorbed from the gastro-intestinal tract and slowly absorbed through the skin. As a result, inspite of their relative greater extent of absorption through oral well as dermal routes, overall contribution of the tocopherols to the systemic dose of the deodorizer distillates could be considered to be low. On the other hand, major constituents of the deodorizer distillates are glycerides and fatty acids of C8 to C18 chain length. Systemic absorption of the shorter chain fatty acids is greater than the longer chain counterparts. Therefore, C8-C12 fatty acids could be considered to show higher degree of systemic absorption compared to the longer chains. With this in mind, coconut oil (rich in C12 and C14 fatty acids) as a representative of the constituent glycerides, C8 -18 and C18 -unsatd.’ would be appropriate and studies conducted with coconut oil as test substance can be regarded as major contributor in the evaluation of repeated dose exposure. Considering the available dermal studies with some of the constituents together with their absorption potential, toxicity of the individual constituents via the dermal route is not expected to be higher than oral route. Exposure via the inhalation route is not expected considering the low vapour pressure of the substance. Further, the inhalation exposure potential in workers where the substance is handled in aerosolized or spray form is considered to be low due to implementation of strict risk management measures at workplace (See sections 9 and 10 of the CSR). Therefore, repeated dose inhalation toxicity is not expected to pose an issue for human health and no further testing is required for this endpoint, in accordance with Annex VIII, column 2 of the REACH regulation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efaba97f-7bc0-467e-ae99-5051014b5948/documents/df53b713-6c03-415e-9e25-a0b678cad4e2_9088dfd2-8f36-4bbe-ad75-80b99b5777c5.html,,,,,, "Soaps, stocks, vegetable-oil, acidulated",68952-95-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efaba97f-7bc0-467e-ae99-5051014b5948/documents/df53b713-6c03-415e-9e25-a0b678cad4e2_9088dfd2-8f36-4bbe-ad75-80b99b5777c5.html,Chronic toxicity – systemic effects,oral,NOAEL,"9,250 mg/kg bw/day",,rat "Soaps, stocks, vegetable-oil, acidulated",68952-95-4," Overall weight of evidence from different studies suggests that the main constituents of ‘Soaps, stocks, vegetable oil, acidulated’ have low acute toxicity following oral and dermal exposure, with LD50 values greater than 2,000 mg/kg. This is in line with their long history of safe use in a wide range of nutritional (food and feed), cosmetic and/or industrial applications. The exposure via the inhalation route is not expected given the low vapour pressure of the substance. Further, the likely inhalation exposure potential in workers where the substance is handled in aerosolized or spray form is considered to be low due implementation of strict risk management measures in workplace (See sections 9 and 10 of the CSR). Therefore, acute inhalation exposure is not expected to pose an issue for human health and no further testing is required for this endpoint according to Annex VIII, Section 8.5, column 2 of the REACH legislation. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efaba97f-7bc0-467e-ae99-5051014b5948/documents/7c5b65bf-bc63-4f5c-8cde-7b0eaac3476b_9088dfd2-8f36-4bbe-ad75-80b99b5777c5.html,,,,,, "Soaps, stocks, vegetable-oil, acidulated",68952-95-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efaba97f-7bc0-467e-ae99-5051014b5948/documents/7c5b65bf-bc63-4f5c-8cde-7b0eaac3476b_9088dfd2-8f36-4bbe-ad75-80b99b5777c5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Soaps, stocks, vegetable-oil, acidulated",68952-95-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efaba97f-7bc0-467e-ae99-5051014b5948/documents/7c5b65bf-bc63-4f5c-8cde-7b0eaac3476b_9088dfd2-8f36-4bbe-ad75-80b99b5777c5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium (3-hydroxy-2-pentylcyclopentyl)acetate,1175006-92-4," Oral: OECD 407, rat, NOAEL = 300 mg/kg bw/day, LOAEL = 1000 mg/kg bw/day, OECD 408, rat, NOEL = 300 mg/kg bw/day Inhalation: no information available Dermal: OECD 410, rat, NOEL = 500 mg/kg bw/day, LOAEL (local) = 1000 mg/kg bw/day or 8 mg/cm^2 (assuming 330 g bw of rat and 41.8 cm^2 body surface, 10 % exposed area) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e91956c3-3ef0-4192-9569-77c5fb3ef44b/documents/IUC5-a66629d1-bb99-4fd3-bfb1-8c2a938c6be0_57d10b98-2fe5-4058-8e7f-16dbe67d61c2.html,,,,,, Sodium (3-hydroxy-2-pentylcyclopentyl)acetate,1175006-92-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e91956c3-3ef0-4192-9569-77c5fb3ef44b/documents/IUC5-a66629d1-bb99-4fd3-bfb1-8c2a938c6be0_57d10b98-2fe5-4058-8e7f-16dbe67d61c2.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,"1,000 mg/kg bw/day",,rat Sodium (3-hydroxy-2-pentylcyclopentyl)acetate,1175006-92-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e91956c3-3ef0-4192-9569-77c5fb3ef44b/documents/IUC5-a66629d1-bb99-4fd3-bfb1-8c2a938c6be0_57d10b98-2fe5-4058-8e7f-16dbe67d61c2.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat Sodium (3-hydroxy-2-pentylcyclopentyl)acetate,1175006-92-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e91956c3-3ef0-4192-9569-77c5fb3ef44b/documents/IUC5-a66629d1-bb99-4fd3-bfb1-8c2a938c6be0_57d10b98-2fe5-4058-8e7f-16dbe67d61c2.html,Repeated dose toxicity – local effects,dermal,LOAEL,8 mg/cm2,adverse effect observed,rat Sodium (3-hydroxy-2-pentylcyclopentyl)acetate,1175006-92-4,"Oral: OECD 420, rat, LD50 > 2000 mg/kg bwInhalation: no information availableDermal: no information available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e91956c3-3ef0-4192-9569-77c5fb3ef44b/documents/IUC5-aa45a47d-ee19-4cde-84fa-9b3beb34a686_57d10b98-2fe5-4058-8e7f-16dbe67d61c2.html,,,,,, "Sodium [[α,α'-(ethylenediimino)bis[2-hydroxybenzene-1-acetato]](4-)]ferrate(1-)",16455-61-1,"In a key subchronic toxicity study (Novartis Crop Protection AG, 1998), FeNaEDDHA in 0.5 % CMC and 0.1 % Tween 80 in distilled water was administered to 10 Sprague-Dawley derived rats/sex/dose level by oral gavage (10 mL/kg bw) at dose levels of 5, 50 or 200 mg/kg bw/day for a period of 90 days. Male and female animals of the concurrent control group were treated with the vehicle only. Additional 10 animals/sex of the high dose and control group were kept on control diet for a 4 -week recovery period before sacrifice. Treatment with the test item resulted in lower food intake and impaired body weight development of rats treated at 200 mg/kg bw/day. Reversible effects on the red blood cell (normochromic anaemia) and white blood cell parameters, and higher values of platelets and prothrombin activity were noted at 50 and/or 200 mg/kg bw/day. In addition, there were changes of blood chemistry and urine parameters concerning the liver and kidneys. The body weight relative heart weight was increased in males at 200 mg/kg bw/day. Under the conditions of this study, the NOAEL for FeNaEDDHA when administered by daily oral gavage for three months was 10 mg/kg bw/day (estimated from the LOAEL).   In a key subacute 28-day dermal toxicity study conducted with a source substance Fe(Na)EDDHA, the NOEL was established at 100 mg/kg bw/day based on slight effects on the liver and skin and due to increased adrenal weight noted at the high dose level of 1000 mg/kg bw/day. No data on repeated inhalation exposure are required. Exposure by the inhalation route is considered to be negligible. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): The dermal study available meets required adequacy criteria and herewith demonstrating a good quality of data base Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): The dermal study available meets required adequacy criteria and herewith demonstrating a good quality of data base Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): There is no deficiencies in the available data set. The data on structurally related substances is reliable and consisitent. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6eb98c2-951f-4df1-9c82-aefd8edd4770/documents/1f99f0fe-c7e3-4a7f-a605-31711c15b138_81ed1c55-889d-4dbc-a2ee-49e1e7b6fc25.html,,,,,, "Sodium [[α,α'-(ethylenediimino)bis[2-hydroxybenzene-1-acetato]](4-)]ferrate(1-)",16455-61-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6eb98c2-951f-4df1-9c82-aefd8edd4770/documents/1f99f0fe-c7e3-4a7f-a605-31711c15b138_81ed1c55-889d-4dbc-a2ee-49e1e7b6fc25.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,,rat "Sodium [[α,α'-(ethylenediimino)bis[2-hydroxybenzene-1-acetato]](4-)]ferrate(1-)",16455-61-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b6eb98c2-951f-4df1-9c82-aefd8edd4770/documents/1f99f0fe-c7e3-4a7f-a605-31711c15b138_81ed1c55-889d-4dbc-a2ee-49e1e7b6fc25.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "Sodium [[α,α'-(ethylenediimino)bis[2-hydroxybenzene-1-acetato]](4-)]ferrate(1-)",16455-61-1," The LD50 values derived from the acute oral toxicity studies with the source substance Fe(Na)EDDHA were > 2000 mg/kg bw. The dermal LD50 of > 2000 mg/kg bw was established, too. The inhalation (4h) LC50 is > 4200 mg/m³ air (maximum attainable concentration) was established for Fe(Na)EDDHA in a limit test. Based on these results, the target substance o-o-EDDHA (EC 240 -505 -9) is considered to be not acutely toxic by all routes of exposure and does not need to be classified and labelled according to CLP. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6eb98c2-951f-4df1-9c82-aefd8edd4770/documents/166e87ef-d92c-42c2-86b3-07a10552c9b8_81ed1c55-889d-4dbc-a2ee-49e1e7b6fc25.html,,,,,, "Sodium [[α,α'-(ethylenediimino)bis[2-hydroxybenzene-1-acetato]](4-)]ferrate(1-)",16455-61-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6eb98c2-951f-4df1-9c82-aefd8edd4770/documents/166e87ef-d92c-42c2-86b3-07a10552c9b8_81ed1c55-889d-4dbc-a2ee-49e1e7b6fc25.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sodium [[α,α'-(ethylenediimino)bis[2-hydroxybenzene-1-acetato]](4-)]ferrate(1-)",16455-61-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6eb98c2-951f-4df1-9c82-aefd8edd4770/documents/166e87ef-d92c-42c2-86b3-07a10552c9b8_81ed1c55-889d-4dbc-a2ee-49e1e7b6fc25.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sodium [[α,α'-(ethylenediimino)bis[2-hydroxybenzene-1-acetato]](4-)]ferrate(1-)",16455-61-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6eb98c2-951f-4df1-9c82-aefd8edd4770/documents/166e87ef-d92c-42c2-86b3-07a10552c9b8_81ed1c55-889d-4dbc-a2ee-49e1e7b6fc25.html,,inhalation,LC50,"4,200 mg/m3",no adverse effect observed, "Sodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-)",10127-27-2," Male and female rats were subjected to acute oral toxicity testing according to a protocol similar to OECD TG 401. The test item was administered at dose levels of 4640, 6000 and 7750 mg/kg bw to 5 male and 5 female rats respectively. During the 14 days observation period one male died and there were no ab normalities found in necropsy, thus leading to an LD50 > 7750 mg/kg bw. Therefore, the test item has not to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95e6f7df-67b7-4174-960a-18815ab87be1/documents/541ce311-b6a7-422f-85a5-d78cd5621e16_78e56843-6528-4417-ac30-77397ad5e30f.html,,,,,, "Sodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]hydroxychromate(1-)",10127-27-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95e6f7df-67b7-4174-960a-18815ab87be1/documents/541ce311-b6a7-422f-85a5-d78cd5621e16_78e56843-6528-4417-ac30-77397ad5e30f.html,,oral,LD50,"7,750 mg/kg bw",adverse effect observed, Sodium [3-hydroxy-4-[(1-hydroxy-5-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-),89899-25-2,The LD50 for FAT 20290/A was found to be >5000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f18c5eee-51e9-464e-b53b-584cbdb70a1a/documents/IUC5-e4e050cb-181a-4e6e-816e-e99e6787f935_44a10402-f45a-4a5b-b3d2-077e9655097b.html,,,,,, Sodium [3-hydroxy-4-[(1-hydroxy-5-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-),89899-25-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f18c5eee-51e9-464e-b53b-584cbdb70a1a/documents/IUC5-e4e050cb-181a-4e6e-816e-e99e6787f935_44a10402-f45a-4a5b-b3d2-077e9655097b.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium [3-hydroxy-4-[(1-hydroxy-8-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-),70942-15-3, LD50(oral) = 5000 mg/kg bw; LC50(inhal) > 2.8 mg/l; LD50(ip) = 380 mg/kg bw. Acute intraperithoneal administration: LD50 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4420c99-6f7f-4515-b68f-a82c30af02be/documents/IUC5-c8eced2f-ec54-4a2f-bde0-bd0656d99f19_174868e2-7478-42e0-a7d8-a564c0243c30.html,,,,,, Sodium [3-hydroxy-4-[(1-hydroxy-8-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-),70942-15-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4420c99-6f7f-4515-b68f-a82c30af02be/documents/IUC5-c8eced2f-ec54-4a2f-bde0-bd0656d99f19_174868e2-7478-42e0-a7d8-a564c0243c30.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium [3-hydroxy-4-[(1-hydroxy-8-sulpho-2-naphthyl)azo]naphthalene-1-sulphonato(4-)]chromate(1-),70942-15-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4420c99-6f7f-4515-b68f-a82c30af02be/documents/IUC5-c8eced2f-ec54-4a2f-bde0-bd0656d99f19_174868e2-7478-42e0-a7d8-a564c0243c30.html,,inhalation,discriminating conc.,2.8 mg/m3,no adverse effect observed, "Sodium [4-[[dihydroxy[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]benzenesulphonato(3-)]cuprate(1-)",95009-01-1," According to the findings of the study, the NOEL of Everlan SL65 for the rats was 62.5 mg/kg B.W. (OECD 407:2008). This was based on blood parameter changes and increase in spleen weight. There were no adverse effects relating to clinical signs. It is unclear if the effects on the spleen were adaptive or of toxicological significance. Damage is also reported to the cecum and colon (this is typical of copper toxicity) and this damage would lead to the blood paramter changes seen. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7298386-c010-444c-b4d5-faa27ef6eae2/documents/6d2716cc-e411-4673-b4e9-e8b6aa6dd90b_9d982a51-0f5f-4d4d-a777-960fcdd02ebd.html,,,,,, "Sodium [4-[[dihydroxy[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]benzenesulphonato(3-)]cuprate(1-)",95009-01-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7298386-c010-444c-b4d5-faa27ef6eae2/documents/6d2716cc-e411-4673-b4e9-e8b6aa6dd90b_9d982a51-0f5f-4d4d-a777-960fcdd02ebd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,62.5 mg/kg bw/day,,rat "Sodium [4-[[dihydroxy[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]benzenesulphonato(3-)]cuprate(1-)",95009-01-1, Acute toxicity: via oral route The LD50 of Everlan Brown EFR Dye Powder was greater than 5000 mg/kg (EPA).   Acute toxicity: via dermal route The LD50 of Everlan SL65 was greater than 2000 mg/kg B.W. (OECD TG402). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7298386-c010-444c-b4d5-faa27ef6eae2/documents/70aa85ea-7627-4659-9546-66e59b4d1f3a_9d982a51-0f5f-4d4d-a777-960fcdd02ebd.html,,,,,, "Sodium [4-[[dihydroxy[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]benzenesulphonato(3-)]cuprate(1-)",95009-01-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7298386-c010-444c-b4d5-faa27ef6eae2/documents/70aa85ea-7627-4659-9546-66e59b4d1f3a_9d982a51-0f5f-4d4d-a777-960fcdd02ebd.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Sodium [4-[[dihydroxy[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]benzenesulphonato(3-)]cuprate(1-)",95009-01-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7298386-c010-444c-b4d5-faa27ef6eae2/documents/70aa85ea-7627-4659-9546-66e59b4d1f3a_9d982a51-0f5f-4d4d-a777-960fcdd02ebd.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzenesulphonato(4-)]chromate(1-)",82933-90-2,The acute toxicity of substance FAT 20043 was determined according to in-house methods before the implementation of OECD guidelines. The methods are considered to be equivalent to current OECD guidelines. The acute oral LD50 of FAT 20043 in rats of both sexes observed over a period of 14 days is greater than 5000 mg/kg. The compound has therefore is not considered to cause acute toxicity to the rat by this route of administration. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/476da4b7-bbb0-494e-bd17-c59f38bfa889/documents/IUC5-c68c5e02-adb4-400f-be49-3dcc3009d40e_8a1b95df-85f4-4381-a7d1-5bac3f7c566e.html,,,,,, "Sodium [5-chloro-3-[[4,5-dihydro-3-methyl-5-oxo-1-(3-sulphophenyl)-1H-pyrazol-4-yl]azo]-2-hydroxybenzenesulphonato(4-)]chromate(1-)",82933-90-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/476da4b7-bbb0-494e-bd17-c59f38bfa889/documents/IUC5-c68c5e02-adb4-400f-be49-3dcc3009d40e_8a1b95df-85f4-4381-a7d1-5bac3f7c566e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium [N-[2-[bis(carboxylatomethyl)amino]ethyl]-N-(2-hydroxyethyl)glycinato(3-)]zincate(1-),71501-24-1, A 28-day repeated dose oral toxicity test (OECD 422) was performed for a category member. No adverse effects were observed in the study. This result applies to all category members and no repeated dose toxicity of the test substance is thus expected. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/13bb62eb-b555-456f-bf31-29b035855167/documents/1566c8be-ab0a-4ac8-9ca8-c865150d3f7e_3bf2a253-67b0-49a3-b41b-aa0dd79d0221.html,,,,,, Sodium [N-[2-[bis(carboxylatomethyl)amino]ethyl]-N-(2-hydroxyethyl)glycinato(3-)]zincate(1-),71501-24-1," Information on the substance itself was only available on acute inhalation toxicity (guideline study) but two guideline studies were available on acute oral toxicity for two category members. In all studies, no effects were observed at concentrations up to the maximum dose for classification (2000 mg/kg for oral study, 5 mg/L for inhalation study). Therefore, it was concluded that the substance itself also does not lead to acute toxic effects. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/13bb62eb-b555-456f-bf31-29b035855167/documents/47e18f21-fd85-4a66-bdc7-28c3d35a8c4b_3bf2a253-67b0-49a3-b41b-aa0dd79d0221.html,,,,,, Sodium [N-[2-[bis(carboxymethyl)amino]ethyl]-N-(2-hydroxyethyl)glycinato(4-)]ferrate(1-),51181-50-1,"In an extended oral OECD 422 study with DTPA-FeHNa male animals were exposed for at least 13 weeks and females for almost 14 weeks. At the high dose level the following effects were observed: soft faeces (both sexes), decreased body weight gain (males), prolonged prothrombin time (males), increased haemoglobin concentration (males), decreased ALAT activity and chloride concentration (males) and decreased ALP activity and increased relative weights of kidneys and liver (both sexes). No toxicologically relevant changes were observed at the lower levels of 500 and 150 mg/kg bw. See also st Discussion. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1bdf3ce0-6160-479d-a5e3-1f03bad71ee8/documents/IUC5-a528c8c8-a57e-4f9c-b54f-afb76c34fc12_ad323d47-8603-4ed7-b0f8-3fbb3d2d3e0a.html,,,,,, Sodium [N-[2-[bis(carboxymethyl)amino]ethyl]-N-(2-hydroxyethyl)glycinato(4-)]ferrate(1-),51181-50-1,"The oral LD50 value is in excess of 2000 mg/kg bw; the 4-h LC50 value for DTPA-FeHNa is in excess of 5.08 g/m3 and that of EDTA-FeNa in excess of 2.75 mg/L. No acute dermal toxicity studies are available but based on read across (see also section 13), acute dermal toxicity following exposure to HEDTA-FeNa is not expected. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bdf3ce0-6160-479d-a5e3-1f03bad71ee8/documents/IUC5-0f56f211-c533-4e66-b600-829daf8c3847_ad323d47-8603-4ed7-b0f8-3fbb3d2d3e0a.html,,,,,, "sodium 1,3,5-triazinane-2,4,6-trione",2624-17-1,"Experimental results from repeated dose studies by the oral route (59 day, 13 week (according to OECD guideline 408) and 104 weeks (according to EU Method B.33) on sodium cyanurate monohydrate or sodium cyanurate. Read-across from a 13-week study with cyanuric acid. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/15ed0001-5f95-4c3b-a9a8-4796d0088f36/documents/IUC5-3251f796-741b-4465-8a10-c268f12b0c8c_cd7c25e7-74b6-4d04-9dbf-673a57f1ab1b.html,,,,,, "sodium 1,3,5-triazinane-2,4,6-trione",2624-17-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/15ed0001-5f95-4c3b-a9a8-4796d0088f36/documents/IUC5-3251f796-741b-4465-8a10-c268f12b0c8c_cd7c25e7-74b6-4d04-9dbf-673a57f1ab1b.html,Chronic toxicity – systemic effects,oral,NOAEL,154 mg/kg bw/day,,rat "sodium 1,3,5-triazinane-2,4,6-trione",2624-17-1,"Read-across from acute oral, dermal and inhalation studies with cyanuric acid. Experimental data showed no evidence of acute toxicity to cyanuric acid. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15ed0001-5f95-4c3b-a9a8-4796d0088f36/documents/IUC5-e5d50d8a-3407-40d6-9dd5-a575849249a6_cd7c25e7-74b6-4d04-9dbf-673a57f1ab1b.html,,,,,, "sodium 1,3,5-triazinane-2,4,6-trione",2624-17-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15ed0001-5f95-4c3b-a9a8-4796d0088f36/documents/IUC5-e5d50d8a-3407-40d6-9dd5-a575849249a6_cd7c25e7-74b6-4d04-9dbf-673a57f1ab1b.html,,oral,LD50,"5,891 mg/kg bw",no adverse effect observed, "sodium 1,3,5-triazinane-2,4,6-trione",2624-17-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15ed0001-5f95-4c3b-a9a8-4796d0088f36/documents/IUC5-e5d50d8a-3407-40d6-9dd5-a575849249a6_cd7c25e7-74b6-4d04-9dbf-673a57f1ab1b.html,,dermal,LD50,"5,891 mg/kg bw",no adverse effect observed, "sodium 1,3,5-triazinane-2,4,6-trione",2624-17-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/15ed0001-5f95-4c3b-a9a8-4796d0088f36/documents/IUC5-e5d50d8a-3407-40d6-9dd5-a575849249a6_cd7c25e7-74b6-4d04-9dbf-673a57f1ab1b.html,,inhalation,LC50,"6,190 mg/m3",no adverse effect observed, "Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate",2373-38-8,"Subacute toxicity was tested with the registered substance in Wistar rats by oral gavage at 0 (vehicle), 100, 300 and 1000 mg/kg bw/day in a supporting 14-day dose range finding and 100, 300 and 1000 reduced to 600 mg/kg bw/day in a key combined repeated dose/reproductive toxicity study (OECD No. 422). The vehicle was distilled water in the 14-day dose range finding and propylene glycol in the OECD 422 study. The NOAEL for local toxicity of the parental generation was 100 mg/kg bw/day (based on local gastric findings). The NOAEL for systemic toxicity of the parental generation was 300 mg/kg bw/day. Subacute oral toxicity was also tested in a supporting preguideline OECD 407 in male rats at 0.125, 0.25 and 0.5% in the diet for 32 days, corresponding with average doses of 130, 250 and 510 mg/kg bw.   Subchronic toxicity was tested with the registered substance in Wistar rats by dietary administration at 0 (control diet), 1500, 3900 and 13000 ppm in a key 90-day repeated dose toxicity study (OECD No. 408). In case of High dose males, the 15000 ppm diet was used from Day 44/45 to Day 90. The NOAEL was 13000 ppm (increased to 15000 ppm in males from day 44/45), corresponding to a mean group test item intake of 870.5 mg/kg bw/day for both sexes (826 mg/kg bw/day in males and 915 mg/kg bw/day in females). Subchronic oral toxicity was also tested in a supporting preguideline study in male and female rats at 1% in the diet for 90 days, corresponding with ca. 750 mg act. ingr./kg bw on average basis: no toxicity was observed at 1% in the diet. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1f251f5-a06b-493a-9b36-a1cd918ca38f/documents/986e2362-eaa5-45e8-a36f-d7b29545d32c_7e9b8484-bb84-4418-8f3d-6140898ebb64.html,,,,,, "Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate",2373-38-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1f251f5-a06b-493a-9b36-a1cd918ca38f/documents/986e2362-eaa5-45e8-a36f-d7b29545d32c_7e9b8484-bb84-4418-8f3d-6140898ebb64.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate",2373-38-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1f251f5-a06b-493a-9b36-a1cd918ca38f/documents/986e2362-eaa5-45e8-a36f-d7b29545d32c_7e9b8484-bb84-4418-8f3d-6140898ebb64.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,870.5 mg/kg bw/day,,rat "Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate",2373-38-8,"Oral acute toxicity was tested according to OECD 401 method in male rats, leading to a LD50 of 1750 mg act.ingr./kg bw. Dermal acute toxicity was tested according to OECD 402 method in male rabbits, demonstrating a LD50 of 4000 mg act.ingr./kg bw. Acute inhalation toxicity was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulfosuccinates due to their substance properties ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1f251f5-a06b-493a-9b36-a1cd918ca38f/documents/35ad4ca0-a047-4072-a2ab-f94b104b92c7_7e9b8484-bb84-4418-8f3d-6140898ebb64.html,,,,,, "Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate",2373-38-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1f251f5-a06b-493a-9b36-a1cd918ca38f/documents/35ad4ca0-a047-4072-a2ab-f94b104b92c7_7e9b8484-bb84-4418-8f3d-6140898ebb64.html,,oral,LD50,"1,750 mg/kg bw",adverse effect observed, "Sodium 1,4-bis(1,3-dimethylbutyl) sulphonatosuccinate",2373-38-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1f251f5-a06b-493a-9b36-a1cd918ca38f/documents/35ad4ca0-a047-4072-a2ab-f94b104b92c7_7e9b8484-bb84-4418-8f3d-6140898ebb64.html,,dermal,LD50,"4,000 mg/kg bw",no adverse effect observed, "Sodium 1,4-diisodecyl sulphonatosuccinate",29857-13-4,"Subacute toxicity was tested with the registered substance in Wistar rats by oral gavage at 0 (propylene glycol), 100, 300 and 1000 mg /kg bw/day in a supporting 14-day dose range finding and at 0 (propylene glycol), 100, 300 and 1000 mg /kg bw/day in a key combined repeated dose/reproductive toxicity study (OECD No. 422). The NOAEL for systemic toxicity of the parental generation was 300 mg/kg bw/day, however this was considered to be due to repeated irritation, and not relevant for humans, therefore in the next studies, the test item was administered via the diet.   Subchronic toxicity was tested with the registered substance in Wistar rats by oral gavage at 0 (control diet), 3900, 7800 and 13000 ppm in the diet in a supporting 14-day palatability and dose range finding and at 0 (control diet), 1300, 3900 and 13000 ppm in a 90-day repeated dose toxicity study with 28-day recovery period (OECD No. 408). The NOAEL for systemic toxicity was 3900 ppm, corresponding to a mean group test item intake of 283.1 mg/kg bw/day for both sexes (251.7 mg/kg bw/day in males, and 314.5 mg/kg bw/day in females).  In a supporting dietary subchronic toxicity study in rats with read-across substance Docusate sodium (CAS 577-11-7), the oral NOAEL of 1000 mg/kg bw/day.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54bf388a-6997-498a-9c0d-e5f3087dd9e3/documents/2a2f6f54-ad53-407a-9055-b406a382db26_f4a8754f-a92e-406d-97c3-07348336270c.html,,,,,, "Sodium 1,4-diisodecyl sulphonatosuccinate",29857-13-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54bf388a-6997-498a-9c0d-e5f3087dd9e3/documents/2a2f6f54-ad53-407a-9055-b406a382db26_f4a8754f-a92e-406d-97c3-07348336270c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Sodium 1,4-diisodecyl sulphonatosuccinate",29857-13-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54bf388a-6997-498a-9c0d-e5f3087dd9e3/documents/2a2f6f54-ad53-407a-9055-b406a382db26_f4a8754f-a92e-406d-97c3-07348336270c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,283.1 mg/kg bw/day,,rat "Sodium 1,4-diisodecyl sulphonatosuccinate",29857-13-4,"Except for an acute oral toxicity study, no test data were available for current substance, however read across data were available from read-across substances CAS No. 577-11-7 and EC 259-515-6 (former CAS No. 55184-72-0). LD50 values were > 2000 mg act.ingr./kg bw. for oral and dermal acute toxicity in key and supporting studies. Inhalation toxicity testing was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulfosuccinates due to their substance properties.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54bf388a-6997-498a-9c0d-e5f3087dd9e3/documents/8b8d8e45-6ad3-4616-84e5-d79ac24c3bd6_f4a8754f-a92e-406d-97c3-07348336270c.html,,,,,, "Sodium 1,4-diisodecyl sulphonatosuccinate",29857-13-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54bf388a-6997-498a-9c0d-e5f3087dd9e3/documents/8b8d8e45-6ad3-4616-84e5-d79ac24c3bd6_f4a8754f-a92e-406d-97c3-07348336270c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sodium 1,4-diisodecyl sulphonatosuccinate",29857-13-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54bf388a-6997-498a-9c0d-e5f3087dd9e3/documents/8b8d8e45-6ad3-4616-84e5-d79ac24c3bd6_f4a8754f-a92e-406d-97c3-07348336270c.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Sodium 1,4-diisotridecyl sulphonatosuccinate",55184-72-0," A subacute oral dietary toxicity equivalent to OECD 407 method in male rats dosed at 0.25, 0.5 and 1 % in the diet for 28 days, corresponding with average doses of 7.47, 74.7 and 812 mg act.ingr./kg bw. A 14 -day dose-range finding toxicity study by oral gavage at 0, 100, 300 and 1000 mg/kg bw/day was well tolerated and only resulted in increased serum Alanine aminotransferase activity in the mid and high dosed males & females and multifocal yellow discoloration and/or thickness in the non-glandular mucosa of the stomach 1000 mg/kg dosed males and females at necrospsy. A key combined repeated dose toxicity with reproduction/developmental toxicity screening test in male and female rats by oral gavage at 0, 100, 300 and 1000 mg/kg bw/day, resulting in slight statistically significant decreases in body weight, weight gain and food intake in females at 1000 mg/kg bw in males (premating and females (during the gestation and lactation period). Test item related non-adverse increases in liver enzymes in the Mid dose males and High dose males and females were considered to be linked to the adaptive response seen in the liver during microscopic examination (hepatocellular hypertrophy and vacuolation which was observed only in High dose animals, but not in Mid or Low dose animals).Hyperkeratosis of the non-glandular gastric mucosa of the stomach was identified at the High dose level (1000 mg/kg bw/day), as test item-related adverse local change. This was related to the irritating properties of the substance. No other relevant parental toxicity findings were observed in the study. Based on the results of this study, the systemic NOAEL for parental toxicity was 300 mg/kg bw/day. The changes in the stomach were not considered relevant for humans as humans do not have a forestomach and exposure conditions were considered to be extreme (daily irritating by bolus administration). Subchronic oral toxicity was further tested equivalent to OECD 408 method in male and female rats at 1% in the diet for 90 days, corresponding with ca. 750 mg act. ingr./kg bw. These studies did not reveal toxicity, therefore 1% in the diet, corresponding with ca. 750 mg act.ingr./kg bw can be accepted as NOAEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60ec70f2-38c6-4136-a075-310d727715b4/documents/5df5f248-4cdd-4ae5-9baa-75fa9dd29f1b_aee4c88e-eb5e-4d74-8686-1f4848f46561.html,,,,,, "Sodium 1,4-diisotridecyl sulphonatosuccinate",55184-72-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60ec70f2-38c6-4136-a075-310d727715b4/documents/5df5f248-4cdd-4ae5-9baa-75fa9dd29f1b_aee4c88e-eb5e-4d74-8686-1f4848f46561.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Sodium 1,4-diisotridecyl sulphonatosuccinate",55184-72-0,"Oral acute toxicity was tested according to OECD 401 method in rats and mice, leading to a LD50 of >7000 mg act.ingr./kg bw. Dermal acute toxicity was tested according to OECD 402 method in male rabbits, demonstrating a LD50 of >3500 mg act.ingr./kg bw. Acute inhalation toxicity was waived based upon the fact that acute inhalation exposure as such is very unlikely for sulfosuccinates due to their substance properties. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60ec70f2-38c6-4136-a075-310d727715b4/documents/a83fc38b-9a5e-42b0-a6e2-d40d2383dc89_aee4c88e-eb5e-4d74-8686-1f4848f46561.html,,,,,, "Sodium 1,4-diisotridecyl sulphonatosuccinate",55184-72-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60ec70f2-38c6-4136-a075-310d727715b4/documents/a83fc38b-9a5e-42b0-a6e2-d40d2383dc89_aee4c88e-eb5e-4d74-8686-1f4848f46561.html,,oral,LD50,"3,500 mg/kg bw",no adverse effect observed, "Sodium 1,4-diisotridecyl sulphonatosuccinate",55184-72-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60ec70f2-38c6-4136-a075-310d727715b4/documents/a83fc38b-9a5e-42b0-a6e2-d40d2383dc89_aee4c88e-eb5e-4d74-8686-1f4848f46561.html,,dermal,LD50,"3,500 mg/kg bw",no adverse effect observed, "Sodium 1-[6-(morpholin-4-yl)pyrimidin-4-yl]-4-(1H-1,2,3-triazol-1-yl)-1H-pyrazol-5-olate",1375799-59-9,"Study report: oral repeated dose toxicity according to OECD test guideline 407 in rats; adverse effects observed [Schladt, 2010] Study report: according to OECD test guideline 408 in rats; NOAEL: 1.5 mg/kg bw. [Schladt, 2012] Study report: according to OECD test guideline 452 in rats; NOAEL females: 1.07 mg/kg bw; NOAEL in males: 0.321 mg/kg bw [Schladt, 2012] Study report: oral repeated dose toxicity, test item in drinking water, administration for 2 weeks, mice: no adverse effects observed under the consitions of the test [Schladt, 2012] Study report: according to OECD test guideline 408 in mice; results: LOEL: 3.21 mg/kg bw [Schladt, 2012] Study report: according to OECD test guideline 451 in mice; results: In a 2-year oncogenicity study in mice, Molidustat is non-carcinogenic. Minor mode of action-related effects on hematopoiesis were observed at 5 mg/kg. Please refer to IUCLID Chapter 7.7. [Popp, 2018] Study report: according to OECD test guideline 409 (modified for the dog) in dogs; NOAEL: 5 mg/kg bw [Ruf, 2010] Study report: according to OECD test guideline 409 (modified for the dog) in dogs; NOAEL: 7.5 mg/kg bw. Study report: according to OECD test guideline 452 (modified for the dog) in dogs; NOAEL: 0.5 mg/kg bw. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): All studies presented were conducted guideline compliant, thus, the whole database is considered of high quality ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/058d06ae-941d-4b17-8706-28986b9eb020/documents/a20ba8f2-5b2a-401b-b6c6-1e71c13a2706_0530b077-d35d-45c4-973c-3a6fa2cbbf1c.html,,,,,, "Sodium 1-[6-(morpholin-4-yl)pyrimidin-4-yl]-4-(1H-1,2,3-triazol-1-yl)-1H-pyrazol-5-olate",1375799-59-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/058d06ae-941d-4b17-8706-28986b9eb020/documents/a20ba8f2-5b2a-401b-b6c6-1e71c13a2706_0530b077-d35d-45c4-973c-3a6fa2cbbf1c.html,Chronic toxicity – systemic effects,oral,NOAEL,0.321 mg/kg bw/day,,rat "Sodium 1-[6-(morpholin-4-yl)pyrimidin-4-yl]-4-(1H-1,2,3-triazol-1-yl)-1H-pyrazol-5-olate",1375799-59-9,"Study report: OECD test guideline 423 in rats; result: Oral LD50 cut-off females: 2500 mg/kg bw [Gillisen, 2009] Study report: OECD test guideline 423 in mice; result: Oral LD50 cut-off females: 1000 mg/kg bw [Gillisen, 2009] Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Data are available from two studies conducted according to OECD 423 (2001) either with rats or mice. Thus, the information is considered to be of reliability 1 (Klimisch scoring). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/058d06ae-941d-4b17-8706-28986b9eb020/documents/da85d762-abfc-4e84-ad45-c2101033acad_0530b077-d35d-45c4-973c-3a6fa2cbbf1c.html,,,,,, "Sodium 1-[6-(morpholin-4-yl)pyrimidin-4-yl]-4-(1H-1,2,3-triazol-1-yl)-1H-pyrazol-5-olate",1375799-59-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/058d06ae-941d-4b17-8706-28986b9eb020/documents/da85d762-abfc-4e84-ad45-c2101033acad_0530b077-d35d-45c4-973c-3a6fa2cbbf1c.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, "Sodium 1-amino-4-[[3,5-bis[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",80010-51-1," FAT 21036 did not cause any adverse effects when administered though oral route in a 14 days range finding study as well as during the main reproductive and developmental screening study. However, read across substance, FAT 20297 was found to have a NOAEL of 282 mg/kg bw/day for females on oral administration for 28 days. Hence, FAT 21036 is also considered to have a NOAEL of 282 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73204da3-4c38-4697-98b4-3db7e0c36c5f/documents/4e46f392-df7d-451b-8485-ed578ff4028e_4e856639-3d17-41ad-81cf-d39ce6f11458.html,,,,,, "Sodium 1-amino-4-[[3,5-bis[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",80010-51-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/73204da3-4c38-4697-98b4-3db7e0c36c5f/documents/4e46f392-df7d-451b-8485-ed578ff4028e_4e856639-3d17-41ad-81cf-d39ce6f11458.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,282 mg/kg bw/day,,rat "Sodium 1-amino-4-[[3,5-bis[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",80010-51-1, Acid Blue 225 is found to have low acute toxicity with oral LD50 >6000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73204da3-4c38-4697-98b4-3db7e0c36c5f/documents/72d49321-c9a1-475b-8d1a-070a3e358a48_4e856639-3d17-41ad-81cf-d39ce6f11458.html,,,,,, "Sodium 1-amino-4-[[3,5-bis[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",80010-51-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73204da3-4c38-4697-98b4-3db7e0c36c5f/documents/72d49321-c9a1-475b-8d1a-070a3e358a48_4e856639-3d17-41ad-81cf-d39ce6f11458.html,,oral,LD50,"6,000 mg/kg bw",no adverse effect observed, "Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",67827-60-5,"LD50 oral = 8850 mg/Kg bw LC50 inhal. > 6 mg/m³ LD50 dermal > 2000 mg/Kg bw Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): low reliability test ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c7bef3f-62c1-47b0-9774-447666825893/documents/IUC5-07d7a074-d3fd-4cae-8c09-bee433a09b63_996d8a18-0aca-4421-9799-2592f135ace2.html,,,,,, "Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",67827-60-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c7bef3f-62c1-47b0-9774-447666825893/documents/IUC5-07d7a074-d3fd-4cae-8c09-bee433a09b63_996d8a18-0aca-4421-9799-2592f135ace2.html,,oral,LD50,"8,850 mg/kg bw",no adverse effect observed, "Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",67827-60-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c7bef3f-62c1-47b0-9774-447666825893/documents/IUC5-07d7a074-d3fd-4cae-8c09-bee433a09b63_996d8a18-0aca-4421-9799-2592f135ace2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sodium 1-amino-4-[[3-[(benzoylamino)methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",67827-60-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c7bef3f-62c1-47b0-9774-447666825893/documents/IUC5-07d7a074-d3fd-4cae-8c09-bee433a09b63_996d8a18-0aca-4421-9799-2592f135ace2.html,,inhalation,LC50,6 mg/m3,no adverse effect observed, "Sodium 1-amino-4-[[3-[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",70209-96-0, Oral LD50 (male and female) > 6000 mg/kg ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4717b8a2-f193-466b-a085-3d8bc0f7bdbb/documents/b668c776-34fb-44de-86ac-28c433cb2b36_82c8d27c-a543-45ac-bf6f-af34d2edc9eb.html,,,,,, "Sodium 1-amino-9,10-dihydro-4-[[(4-methylphenyl)sulphonyl]amino]-9,10-dioxoanthracene-2-sulphonate",64981-00-6,No acute toxicity expected ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9a05f706-bf6e-48db-a847-f6e2f92aafdf/documents/73586041-62b8-42cc-9765-58c8abfe6342_57e1f2a7-e381-428b-8c74-cfdf01106368.html,,,,,, "Sodium 1-amino-9,10-dihydro-4-[[4-[[(4-methylphenyl)sulphonyl]oxy]phenyl]amino]-9,10-dioxoanthracene-2-sulphonate",67969-88-4, The test item has a LD50 > 2000 mg/kg determined an acute toxicity study with female and male rats. The classification criteria are not met. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/70d86852-eb83-471b-94eb-62821b9eef65/documents/e10bd15b-3e0b-495c-a8e3-0fb33ea42b5a_9dadfcde-7334-4a86-b5d2-59cbcd6eaebe.html,,,,,, "Sodium 1-amino-9,10-dihydro-4-[[4-[[methyl[(4-methylphenyl)sulphonyl]amino]methyl]phenyl]amino]-9,10-dioxoanthracene-2-sulphonate",72828-82-1, The structural analogue has a LD50 > 2000 mg/kg determined an acute toxicity study with female and male rats. The classification criteria are not met. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa00632b-ca0a-4cc4-b4a0-eac3f5508db9/documents/b9e2dc93-ec08-4d3c-a368-0b69ee69a1a7_64325d5b-774c-44fd-84d3-77402202ca50.html,,,,,, "Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate",25797-81-3,The NOAEL of the test substance is 1000 mg/kg body weight for male and females rats when administered orally by gavage. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82334a21-65dd-47f1-ac27-509d5da4dff7/documents/IUC5-c57262d0-5635-4899-9813-519088d7273c_5d67c4be-4cd0-4c37-bdc1-4f7b1b667222.html,,,,,, "Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate",25797-81-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/82334a21-65dd-47f1-ac27-509d5da4dff7/documents/IUC5-c57262d0-5635-4899-9813-519088d7273c_5d67c4be-4cd0-4c37-bdc1-4f7b1b667222.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Sodium 1-amino-9,10-dihydro-4-[5-[(2-hydroxyethyl)sulphamoyl]-3,4-xylidino]-9,10-dioxoanthracene-2-sulphonate",25797-81-3,"The acute lethal doses for Acid Blue 277 via oral, dermal and inhalation routes were >5000 mg/kg bw, >3000 mg/kg bw and >0.29 mg/L, respectively.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82334a21-65dd-47f1-ac27-509d5da4dff7/documents/IUC5-9210fb26-70e7-427d-96db-8adc58b67cd7_5d67c4be-4cd0-4c37-bdc1-4f7b1b667222.html,,,,,, "Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[(2,2,4-trimethylcyclohexyl)amino]anthracene-2-sulphonate",71873-46-6, Oral LD50 (male and female): 9476.1 mg/kg bw (6633.27 mg/kg bw based on the active ingredient) ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ace292bc-5022-4d42-9da1-648bc7049c73/documents/d777dfb0-1129-46be-98a4-fc46ec16fffa_4e18a262-4448-4524-90c7-a579140d7199.html,,,,,, "Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[(2,2,4-trimethylcyclohexyl)amino]anthracene-2-sulphonate",71873-46-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ace292bc-5022-4d42-9da1-648bc7049c73/documents/d777dfb0-1129-46be-98a4-fc46ec16fffa_4e18a262-4448-4524-90c7-a579140d7199.html,,oral,LD50,"9,476 mg/kg bw",no adverse effect observed, "Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[(phenylsulphonyl)amino]anthracene-2-sulphonate",67401-67-6,No acute toxicity expected ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66b6a89e-2ff6-4d1b-b372-d3788952bc2c/documents/a5717a57-ba71-4640-bf65-d76d827ed672_50354a54-0ac5-4c82-a208-b1d0d73178c5.html,,,,,, "Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[3-[(1-oxopropyl)amino]phenyl]amino]anthracene-2-sulphonate",89923-62-6,The acute oral LD50 was found to be greater than 2500 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca54e44f-cee7-4195-8a18-fe4780e432e6/documents/IUC5-57e62987-adbb-4818-8f39-8e7ef68fb1a8_dbdcb9b4-923f-47f4-9154-4888e924f63d.html,,,,,, "Sodium 1-amino-9,10-dihydro-9,10-dioxo-4-[[3-[(1-oxopropyl)amino]phenyl]amino]anthracene-2-sulphonate",89923-62-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca54e44f-cee7-4195-8a18-fe4780e432e6/documents/IUC5-57e62987-adbb-4818-8f39-8e7ef68fb1a8_dbdcb9b4-923f-47f4-9154-4888e924f63d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Sodium 1-amino-9,10-dioxo-4-phenylaminoanthracene-2-sulphonate",6408-78-2,LD50(oral) > 15000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58a8a40d-707f-4f57-9c68-c6d52d3b5e1c/documents/IUC5-772d8f38-3c87-4111-9ecb-c429102d470b_7beb2cc0-6716-43e7-a2fb-40730d6a6073.html,,,,,, "Sodium 1-amino-9,10-dioxo-4-phenylaminoanthracene-2-sulphonate",6408-78-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/58a8a40d-707f-4f57-9c68-c6d52d3b5e1c/documents/IUC5-772d8f38-3c87-4111-9ecb-c429102d470b_7beb2cc0-6716-43e7-a2fb-40730d6a6073.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, Sodium 1H-benzotriazolide,15217-42-2,"Read across from two studies (one sub-acute, one chronic) for the oral route,one 14 day Range-finding study available supporting the Read across.The selected NOAEL of 150 mg/kg bw/day is observed in the sub-acute study for the analogue Tolyltriazole. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/746dd71a-b28a-4705-b685-22626766258f/documents/IUC5-6c0e3867-c9bd-414d-a667-541b645346ae_e78b2510-981e-4a57-a430-490b2ff3f5db.html,,,,,, Sodium 1H-benzotriazolide,15217-42-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/746dd71a-b28a-4705-b685-22626766258f/documents/IUC5-6c0e3867-c9bd-414d-a667-541b645346ae_e78b2510-981e-4a57-a430-490b2ff3f5db.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Sodium 1H-benzotriazolide,15217-42-2,"The substance has an oral LD50 of 500 mg/kg bw. In an acute dermal toxicity test for an analogue the limit dose of 2000 mg/kg bw did not lead to mortality, the dermal LD50 is set to 2000 mg/kg bw by default.An inhalative LD50 is not available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/746dd71a-b28a-4705-b685-22626766258f/documents/IUC5-472ac500-496f-4972-8af4-60367622aca2_e78b2510-981e-4a57-a430-490b2ff3f5db.html,,,,,, Sodium 1H-benzotriazolide,15217-42-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/746dd71a-b28a-4705-b685-22626766258f/documents/IUC5-472ac500-496f-4972-8af4-60367622aca2_e78b2510-981e-4a57-a430-490b2ff3f5db.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Sodium 1H-benzotriazolide,15217-42-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/746dd71a-b28a-4705-b685-22626766258f/documents/IUC5-472ac500-496f-4972-8af4-60367622aca2_e78b2510-981e-4a57-a430-490b2ff3f5db.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 1-hydroxyethanesulphonate,918-04-7," Under the conditions of a GLP Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test according to the OECD guideline 422, the oral administration of the test substance by gavage to male and female Wistar rats revealed no adverse signs of toxicity up to the highest dose level of 1000 mg/kg bw/d. The no observed adverse effect level (NOAEL) for general systemic toxicity was 1000 mg/kg bw/d for male and female Wistar rats. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/322f5d3c-e196-43ff-8ce7-33d2f9d77dfa/documents/48f1079d-da57-45cb-9857-fa21af41203e_d4cf6ab4-c9ed-4c9c-8cdd-00d6edc38831.html,,,,,, Sodium 1-hydroxyethanesulphonate,918-04-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/322f5d3c-e196-43ff-8ce7-33d2f9d77dfa/documents/48f1079d-da57-45cb-9857-fa21af41203e_d4cf6ab4-c9ed-4c9c-8cdd-00d6edc38831.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium 1-hydroxyethanesulphonate,918-04-7," An acute oral toxicity study in rats similar to OECD Guideline 401 is available (BASF SE, 1981). Male and female rats were treated with 2150, 2610, 3160, 3830, or 4640 mg/kg of the test substance via gavage and then observed for 14 days. Dyspnea, gasping, apathy, abnormal position, twitching, spastic gait, ruffled fur, ptosis, falling backwards and poor general state were observed as clinical signs. Animals that died showed lung congestion and passive hyperemia in the liver. No abnormalities were found in the surviving animals. The approximate LD50after 14 days was calculated to be 3402.0 mg/kg. In an acute inhalation study (similar to OECD Guideline 403; BASF SE, 1981b), rats were exposed to dust-aerosols of the test material at a concentration of 5.78 mg/L for 4 hours. After the exposure period the animals were observed for 14 days. No mortality and no abnormalities in gross pathology were observed. There were no differences in body weight development between treated and control animals. Mild clinical signs (snout wiping during exposure, liquid up to reddened nasal secretion after exposure) were recorded, but the animals were without findings after one day. In conclusion, the LC50was >5.78 mg/L. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/322f5d3c-e196-43ff-8ce7-33d2f9d77dfa/documents/08243d28-d558-42f8-a385-62f3c61c09e3_d4cf6ab4-c9ed-4c9c-8cdd-00d6edc38831.html,,,,,, "Sodium 2-(2,3-dihydro-1,3-dioxo-1H-inden-2-yl)quinoline-6-sulphonate",84864-68-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): SSS QSAR Prediction data ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1e3d7d4-ff97-4024-a00c-241739655c14/documents/IUC5-3e610e92-0ba5-43f1-90fe-357608b4d403_57f34af1-000f-4803-801c-b680deb2acbb.html,,,,,, "Sodium 2-(2,3-dihydro-1,3-dioxo-1H-inden-2-yl)quinoline-6-sulphonate",84864-68-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1e3d7d4-ff97-4024-a00c-241739655c14/documents/IUC5-3e610e92-0ba5-43f1-90fe-357608b4d403_57f34af1-000f-4803-801c-b680deb2acbb.html,,oral,LD50,"2,664.359 mg/kg bw",no adverse effect observed, "Sodium 2(or 5)-[[1-amino-4-[[3-[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxo-2-anthryl]oxy]-5(or 2)-(tert-butyl)benzenesulphonate",72391-23-2, The median lethal dose (LD50) of Acid Violet 109 through oral route of administration in rats is >2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9935603b-c704-46ec-b664-e93510ba38b8/documents/IUC5-2a560747-b084-4992-bd08-8377e07970e6_d5cc1175-2c1a-44c0-9cba-c4d58761d5a3.html,,,,,, "Sodium 2(or 5)-[[1-amino-4-[[3-[[(chloroacetyl)amino]methyl]-2,4,6-trimethylphenyl]amino]-9,10-dihydro-9,10-dioxo-2-anthryl]oxy]-5(or 2)-(tert-butyl)benzenesulphonate",72391-23-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9935603b-c704-46ec-b664-e93510ba38b8/documents/IUC5-2a560747-b084-4992-bd08-8377e07970e6_d5cc1175-2c1a-44c0-9cba-c4d58761d5a3.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 2-(p-aminoanilino)-5-nitrobenzenesulphonate,14846-08-3," LD50 was estimated to be 5072 mg/kg bw, when female wistar rat were exposed with sodium 2-[(4-aminophenyl)amino]-5-nitrobenzene-1-sulfonate (14846-08-3) orally. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fbd57061-202a-4092-964e-6e60718c8d4e/documents/4dc5de01-633a-461c-9cfa-db005b556d50_03cfd86c-fd0d-4b1d-a082-16cc045c2243.html,,,,,, Sodium 2-(p-aminoanilino)-5-nitrobenzenesulphonate,14846-08-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fbd57061-202a-4092-964e-6e60718c8d4e/documents/4dc5de01-633a-461c-9cfa-db005b556d50_03cfd86c-fd0d-4b1d-a082-16cc045c2243.html,,oral,LD50,"5,072 mg/kg bw",no adverse effect observed, "Sodium 2,4-diamino-5-(2-hydroxy-5-nitrophenylazo)benzenesulphonate",3618-62-0," Acute oral toxicity, LD50: > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c711c656-88e5-4827-b751-529c14be745c/documents/1c48e488-77b5-4fd1-9077-f4be2b4ac3ce_7a023e21-d0f6-4b23-a27b-d24f056888e8.html,,,,,, "Sodium 2,4-diamino-5-(2-hydroxy-5-nitrophenylazo)benzenesulphonate",3618-62-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c711c656-88e5-4827-b751-529c14be745c/documents/1c48e488-77b5-4fd1-9077-f4be2b4ac3ce_7a023e21-d0f6-4b23-a27b-d24f056888e8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sodium 2,4-dichlorophenoxyacetate",2702-72-9,"RA-S, CAS 2008-39-1, Key, Charles, 1996, 90 d, rats, RL2 - NAEL 15 mg/kg bw/d RA-S, CAS 2008-39-1, Charles, 1996, 90 d, dog, RL2 - NOAEL 1 mg/kg bw/d ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e77f8190-af33-4b29-8e3a-b101dfb78eed/documents/IUC5-7a3a6fa8-c0c1-4bde-8839-9d4745bd071a_00c6239f-40ec-4591-a65e-2c53edc64a3a.html,,,,,, "Sodium 2,4-dichlorophenoxyacetate",2702-72-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e77f8190-af33-4b29-8e3a-b101dfb78eed/documents/IUC5-7a3a6fa8-c0c1-4bde-8839-9d4745bd071a_00c6239f-40ec-4591-a65e-2c53edc64a3a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "Sodium 2,4-dichlorophenoxyacetate",2702-72-9,"Oral ToxicityKey, NZPO ""Organika-Rokita, Kita, 1991, acute oral, RL2 – LD50 = 552 mg/kg bwInhalative ToxicityRA-S, CAS 2008-39-1, Key, Rydzynski and Swiercz, 1998, Aminopielik 600, rat, acute inhal., RL2 – LC50 >3080 mg/m³ air (females) and 3258 mg/m³ air (males) (based on an active ingredient content of 60.6% and doses of 5083 mg/m³ air (females) and 5377 mg/m³ air (males) used in the respective study)Dermal toxicityKey, NZPO ""Organika-Rokita"", Kita, 1991, Acute dermal, rat, RL1- LD50 > 5000 mg/kg bw ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e77f8190-af33-4b29-8e3a-b101dfb78eed/documents/IUC5-b469dfa2-cbe6-4573-a432-15ed79c47393_00c6239f-40ec-4591-a65e-2c53edc64a3a.html,,,,,, "Sodium 2,4-dichlorophenoxyacetate",2702-72-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e77f8190-af33-4b29-8e3a-b101dfb78eed/documents/IUC5-b469dfa2-cbe6-4573-a432-15ed79c47393_00c6239f-40ec-4591-a65e-2c53edc64a3a.html,,oral,LD50,552 mg/kg bw,, "Sodium 2,4-dichlorophenoxyacetate",2702-72-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e77f8190-af33-4b29-8e3a-b101dfb78eed/documents/IUC5-b469dfa2-cbe6-4573-a432-15ed79c47393_00c6239f-40ec-4591-a65e-2c53edc64a3a.html,,dermal,LD50,"3,080 mg/kg bw",, "Sodium 2,4-dichlorophenoxyacetate",2702-72-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e77f8190-af33-4b29-8e3a-b101dfb78eed/documents/IUC5-b469dfa2-cbe6-4573-a432-15ed79c47393_00c6239f-40ec-4591-a65e-2c53edc64a3a.html,,inhalation,LC50,"5,000 mg/m3",, "Sodium 2,5-dichloro-4-[4-[[2-[(ethylphenylamino)sulphonyl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonate",12217-38-8, LD50 > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83a12d27-08fe-4dc7-9dee-702bbc4b2f94/documents/a7ceacef-7964-4a98-953e-bb1152f8c326_0522b3d5-4727-402e-ad8b-90735b4a67ed.html,,,,,, Sodium 2-[(2-aminoethyl)amino]ethanesulphonate,34730-59-1,"A subacute toxicity study on rats (OECD 407, GLP compliant) in doses of up to and including 1000 mg/kg bw AAS gave no indication of toxicologically relevant treatment-related findings. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d219705-3018-4676-9bfc-6cae43303324/documents/IUC5-503ff6cd-828f-46c9-8ecc-5e71c9b76aca_584e7356-e9ab-42c3-bdf9-a5ba59e63f9c.html,,,,,, Sodium 2-[(2-aminoethyl)amino]ethanesulphonate,34730-59-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4d219705-3018-4676-9bfc-6cae43303324/documents/IUC5-503ff6cd-828f-46c9-8ecc-5e71c9b76aca_584e7356-e9ab-42c3-bdf9-a5ba59e63f9c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium 2-[(2-aminoethyl)amino]ethanesulphonate,34730-59-1,"Acute oral toxicity: LD50 > 2000 mg/kg bw, OECD Guideline 423, GLP compliantAcute dermal toxicity: LD50 > 2000 mg/kg bw, OECD Guideline 402, GLP compliant ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d219705-3018-4676-9bfc-6cae43303324/documents/IUC5-7dc2f3f8-11c6-4a35-8f16-7810a5977b26_584e7356-e9ab-42c3-bdf9-a5ba59e63f9c.html,,,,,, Sodium 2-[(2-aminoethyl)amino]ethanesulphonate,34730-59-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d219705-3018-4676-9bfc-6cae43303324/documents/IUC5-7dc2f3f8-11c6-4a35-8f16-7810a5977b26_584e7356-e9ab-42c3-bdf9-a5ba59e63f9c.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Sodium 2-[(2-aminoethyl)amino]ethanesulphonate,34730-59-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d219705-3018-4676-9bfc-6cae43303324/documents/IUC5-7dc2f3f8-11c6-4a35-8f16-7810a5977b26_584e7356-e9ab-42c3-bdf9-a5ba59e63f9c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Sodium 2-[[2-amino-8-hydroxy-6-[(methylanilino)sulphonyl]-1-naphthyl]azo]-5-(chloroacetamido)benzenesulphonate,70209-97-1,"Acute Oral Toxicity: Acute oral toxicity test was conducted according to OECD 401 guideline and in accordance with GLP in 1996. In this study the test substance was administered to a Wistar rats (5/sex) by oral gavage, at a single dose of 2000 mg test substance / kg body weight. There were no deaths as a result of treatment with the test article, no clinical signs of toxicity were observed during the observation period. The body weight of the animals was within the normal range for rats of this strain and age and no organ abnormalities were observed at necropsy. Based on the study results, the mean lethal dose (LD50) of FAT 20075/B after single oral administration to rats of both sexes, observed over a period of 14 days is greater than 2000 mg/kg.   Acute Inhalation Toxicity: Currently no study to assess acute inhalation toxicity of Acid Red 252 is available. However, low vapour pressure (1.13 × 10-3Pa) for the substance and the high melting point (>350 °C), the substance is considered to have low volatility. Synthesis of this chemical is performed in a closed process; the final product consists of non-dusty granules. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets. Referring to the expected low volatility of the substance, the fact that the substance is imported into the EU in a formulated form as a dust-free powder or as a granulate, the exposure via inhalation is unlikely. The chemical showed low toxicity potential in the available acute oral (LD50>2000 mg/kg bw), with no mortality or systemic toxicity, hence it does not need to be classified as STOT SE. Taking into consideration the above arguments, low toxicity potential is expected on acute exposure of Acid Red 252 via inhalation route.   Acute Dermal Toxicity: Currently no study to assess the acute dermal toxicity of Acid Red 252 is available. However, this substance found to have high molecular weight 626 g/mol, this indicates that partition of the substance from stratum corneum into the epidermis will be low, thereby further limiting the absorption if any dermal exposure occurs. Synthesis of this chemical is performed in a closed process without isolation of reaction products. Isolated products consist of either liquid formulations or dust free granules (non-dusty solid). In addition, the use of this substance will not result in aerosols, particles or droplets, so exposure to humans via the dermal route will be unlikely to occur. The chemical showed low toxicity potential in the available acute oral (LD50>2000 mg/kg bw), with no mortality or systemic toxicity, hence it does not need to be classified as STOT SE. Similarly, absence of local toxicity in eye and skin irritation studies as well as absence of systemic toxicity in sensitization studies, further supports the conclusion that low toxicity is expected for the chemical via the dermal route. Taking into consideration the above arguments, low toxicity potential is expected on acute exposure of Acid Red 252 via dermal route and hence acute toxicity testing by the dermal route was considered scientifically not necessary. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): OECD guideline and GLP compliance study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cc79840-1665-4efa-a766-b6485408eb43/documents/IUC5-daa2fbfb-397a-4dd6-8f41-e1eb5f753629_da3d482c-fc86-4c74-8aff-53f9c4caaad9.html,,,,,, Sodium 2-[[2-amino-8-hydroxy-6-[(methylanilino)sulphonyl]-1-naphthyl]azo]-5-(chloroacetamido)benzenesulphonate,70209-97-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2cc79840-1665-4efa-a766-b6485408eb43/documents/IUC5-daa2fbfb-397a-4dd6-8f41-e1eb5f753629_da3d482c-fc86-4c74-8aff-53f9c4caaad9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sodium 2-[[4-(cyclohexylamino)-9,10-dihydro-9,10-dioxo-1-anthryl]amino]-5-ethoxybenzenesulphonate",68214-62-0, Not harmful/toxic if swallowed ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1830050c-e1ec-48a8-9158-d41d9d7377b0/documents/96345ee1-20b4-4e30-8388-106fd0b099d0_70d7d80f-c24e-4f6c-9364-bcfbc7b2908b.html,,,,,, "Sodium 2-[[4-[3-(4,5-dichloro-2-methylphenyl)-4,5-dihydro-1H-pyrazol-1-yl]phenyl]sulphonyl]ethanesulphonate",35441-13-5, LD50 (male and female) > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f33a169-aadf-4da2-9814-3d2fa3af428c/documents/44c9cf79-5c0f-4196-abae-a2733545fcb3_5d1de145-d2c1-4083-987c-2d0e42febcbd.html,,,,,, "Sodium 2-[[4-[3-(4-chlorophenyl)-4,5-dihydro-1H-pyrazol-1-yl]phenyl]sulphonyl]ethanesulphonate",27441-70-9, LD50 (male and female) > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5da4e8e8-da97-4598-b22c-88b5c7d8f60d/documents/122e951d-49f7-411a-8e1f-e31f74a6dcea_a98e3f93-ee97-4c5b-bb60-402b16bbce31.html,,,,,, "sodium 2-[N-[(3,5-difluorophenyl)carbamoylamino]-C-methylcarbonimidoyl]pyridine-3-carboxylate",109293-98-3,"Repeated dose toxicity: oralkey study: A combined chronic toxicity/carcinogenicity feeding study in rats (104 weeks) was conducted with a structural analogue substance (free acid of the test item). The NOAEL of the study was considered to be 1500 ppm of the test item, equivalent to a mean daily test substance intake of approximately 69 or 93 mg/kg bw/day in male and female animals, respectively.Supporting studies: Further supporting studies conducted with the structural analogue substance using a range of mammalian species (dogs, rats and mice) were conducted. These studies support the results of the key study.Repeated dose toxicity: dermalKey study: It was considered that 1000 mg/kg/day represents the no-observed adverse effect level (NOAEL) for the test item formulation in the rabbit when administered dermally for at least 21 days.Supporting study: A further supporting study conducted on a structural analogue substance (free acid of the test item) supports the result of the key study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d108fa2-7555-45a3-99f0-5a94959bc1fa/documents/IUC5-0eefe5a7-ca5c-4f62-a0af-ef8a11de0ed0_7d77c2f4-b062-4821-9b34-967ea65b6dfe.html,,,,,, "sodium 2-[N-[(3,5-difluorophenyl)carbamoylamino]-C-methylcarbonimidoyl]pyridine-3-carboxylate",109293-98-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d108fa2-7555-45a3-99f0-5a94959bc1fa/documents/IUC5-0eefe5a7-ca5c-4f62-a0af-ef8a11de0ed0_7d77c2f4-b062-4821-9b34-967ea65b6dfe.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rabbit "sodium 2-[N-[(3,5-difluorophenyl)carbamoylamino]-C-methylcarbonimidoyl]pyridine-3-carboxylate",109293-98-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d108fa2-7555-45a3-99f0-5a94959bc1fa/documents/IUC5-0eefe5a7-ca5c-4f62-a0af-ef8a11de0ed0_7d77c2f4-b062-4821-9b34-967ea65b6dfe.html,Chronic toxicity – systemic effects,oral,NOAEL,69 mg/kg bw/day,,rat "sodium 2-[N-[(3,5-difluorophenyl)carbamoylamino]-C-methylcarbonimidoyl]pyridine-3-carboxylate",109293-98-3,"In two acute oral toxicity studies with the test substance and the read-across test substance similar results were obtained with LD50 values of 4000 mg/kg bw and greater than 5000 mg/kg bw respectively. In an acute oral toxicity study that examined the neurotoxicity potential of the read-across test substance, no evidence of neurotoxicity at dosages up to 2000 mg/kg bw was found. An acute inhalation toxicity study (limit test) was performed with the read-across test substance (free acid of Diflufenzopyr sodium salt). The LC50 value determined was greater than 2.93 mg/L. In two acute dermal toxicity studies with the test substance and the read-across test substance (free acid of Diflufenzopyr sodium salt) an LD50 value of greater than 5000 mg/kg bw was obtained. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d108fa2-7555-45a3-99f0-5a94959bc1fa/documents/IUC5-b2252a56-595e-438b-aef0-ebf2d2dd3041_7d77c2f4-b062-4821-9b34-967ea65b6dfe.html,,,,,, "sodium 2-[N-[(3,5-difluorophenyl)carbamoylamino]-C-methylcarbonimidoyl]pyridine-3-carboxylate",109293-98-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d108fa2-7555-45a3-99f0-5a94959bc1fa/documents/IUC5-b2252a56-595e-438b-aef0-ebf2d2dd3041_7d77c2f4-b062-4821-9b34-967ea65b6dfe.html,,oral,LD50,"4,000 mg/kg bw",no adverse effect observed, "sodium 2-[N-[(3,5-difluorophenyl)carbamoylamino]-C-methylcarbonimidoyl]pyridine-3-carboxylate",109293-98-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d108fa2-7555-45a3-99f0-5a94959bc1fa/documents/IUC5-b2252a56-595e-438b-aef0-ebf2d2dd3041_7d77c2f4-b062-4821-9b34-967ea65b6dfe.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "sodium 2-[N-[(3,5-difluorophenyl)carbamoylamino]-C-methylcarbonimidoyl]pyridine-3-carboxylate",109293-98-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d108fa2-7555-45a3-99f0-5a94959bc1fa/documents/IUC5-b2252a56-595e-438b-aef0-ebf2d2dd3041_7d77c2f4-b062-4821-9b34-967ea65b6dfe.html,,inhalation,discriminating conc.,"2,930 mg/m3",no adverse effect observed, Sodium 2-aminosulphanilate,3177-22-8, Low acute toxicity. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be77a63f-94be-4483-9703-b995f7fd7702/documents/169e1e11-fc5d-42c8-8cb2-1661e2121f68_96eb059b-540a-45d3-b4e7-54714c9807f2.html,,,,,, Sodium 2-bromoethanesulphonate,4263-52-9," In an acute toxicity study in rats according to OECD Guideline 423, an LD50 of above 2000 mg/kg bw was determined (UN GHS: No Category) (reference 7.2.1-1). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac27bd13-7b7c-4a8f-959f-fae5202e481f/documents/c67d987b-5e78-46a7-9a84-ee24ce0b1455_4e993976-77f7-434a-a963-c7f41991fde0.html,,,,,, Sodium 2-bromoethanesulphonate,4263-52-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac27bd13-7b7c-4a8f-959f-fae5202e481f/documents/c67d987b-5e78-46a7-9a84-ee24ce0b1455_4e993976-77f7-434a-a963-c7f41991fde0.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Sodium 2-butoxyethyl sulphate,67656-24-0," Screening study for reproductive/developmental toxicity (OECD 422, oral, rat, RL1): NOAEL reproductive toxicity ≥ 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d1b5d39-a2e3-4552-a94d-dfcf9977192a/documents/cc822931-f77b-4fb2-b114-35cb96c358d6_237c1b78-d762-4ec3-b9af-9f326afe5438.html,,,,,, Sodium 2-butoxyethyl sulphate,67656-24-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d1b5d39-a2e3-4552-a94d-dfcf9977192a/documents/cc822931-f77b-4fb2-b114-35cb96c358d6_237c1b78-d762-4ec3-b9af-9f326afe5438.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium 2-butoxyethyl sulphate,67656-24-0," Weight of Evidence approach for oral acute toxicity: OECD 401, rat: LD50 > 1232 mg/kg bw, OECD 422 study in rats: NOAEL >= 1000 mg/kg bw/day, QSAR: low acute toxicity Dermal (OECD 402), rat: LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d1b5d39-a2e3-4552-a94d-dfcf9977192a/documents/e905d27b-98e2-48df-97a3-cce850a91671_237c1b78-d762-4ec3-b9af-9f326afe5438.html,,,,,, Sodium 2-butyloctyl sulphate,94200-74-5,For the whole category of alkyl sulfates (AS) a NOAEL of 488 mg/kg bw/day was established. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c16e0b2-44de-4cbd-96fb-88be4e001d0d/documents/IUC5-7d409fa6-520a-4fe6-9771-d619857dfdd0_56f08145-7d67-46b4-8abe-8c93176b8af8.html,,,,,, Sodium 2-butyloctyl sulphate,94200-74-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c16e0b2-44de-4cbd-96fb-88be4e001d0d/documents/IUC5-7d409fa6-520a-4fe6-9771-d619857dfdd0_56f08145-7d67-46b4-8abe-8c93176b8af8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,488 mg/kg bw/day,,rat Sodium 2-butyloctyl sulphate,94200-74-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5c16e0b2-44de-4cbd-96fb-88be4e001d0d/documents/IUC5-7d409fa6-520a-4fe6-9771-d619857dfdd0_56f08145-7d67-46b4-8abe-8c93176b8af8.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,,mouse Sodium 2-butyloctyl sulphate,94200-74-5,"Oral LD50 (OECD guideline 401), rat = 1200 mg/kg bwDermal LD50 (OECD guideline 402), rabbit > 2000 mg/kg bw (limit test) Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c16e0b2-44de-4cbd-96fb-88be4e001d0d/documents/IUC5-5816cbff-186f-482a-9936-1f1aa3b131f1_56f08145-7d67-46b4-8abe-8c93176b8af8.html,,,,,, Sodium 2-butyloctyl sulphate,94200-74-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c16e0b2-44de-4cbd-96fb-88be4e001d0d/documents/IUC5-5816cbff-186f-482a-9936-1f1aa3b131f1_56f08145-7d67-46b4-8abe-8c93176b8af8.html,,oral,LD50,"1,200 mg/kg bw",adverse effect observed, Sodium 2-butyloctyl sulphate,94200-74-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c16e0b2-44de-4cbd-96fb-88be4e001d0d/documents/IUC5-5816cbff-186f-482a-9936-1f1aa3b131f1_56f08145-7d67-46b4-8abe-8c93176b8af8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 2-ethylhexanoate,19766-89-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable without restriction ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a342a347-572d-4b0b-8a4e-b530138363f0/documents/IUC5-e2e1bee3-8e4e-40e9-8056-402939e78a4d_66f71b6f-4ae8-4106-b2a1-e68f251d981a.html,,,,,, Sodium 2-ethylhexanoate,19766-89-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a342a347-572d-4b0b-8a4e-b530138363f0/documents/IUC5-e2e1bee3-8e4e-40e9-8056-402939e78a4d_66f71b6f-4ae8-4106-b2a1-e68f251d981a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Sodium 2-ethylhexanoate,19766-89-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable with restrictions Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): reliable with restrictions Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): reliable without restrictions ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a342a347-572d-4b0b-8a4e-b530138363f0/documents/IUC5-780473ed-9f4b-489c-9651-3e7c9571b799_66f71b6f-4ae8-4106-b2a1-e68f251d981a.html,,,,,, Sodium 2-ethylhexanoate,19766-89-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a342a347-572d-4b0b-8a4e-b530138363f0/documents/IUC5-780473ed-9f4b-489c-9651-3e7c9571b799_66f71b6f-4ae8-4106-b2a1-e68f251d981a.html,,oral,LD50,"2,043 mg/kg bw",no adverse effect observed, Sodium 2-ethylhexanoate,19766-89-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a342a347-572d-4b0b-8a4e-b530138363f0/documents/IUC5-780473ed-9f4b-489c-9651-3e7c9571b799_66f71b6f-4ae8-4106-b2a1-e68f251d981a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sodium 2-heptyl-2,3-dihydro-3-(2-hydroxyethyl)-1H-imidazole-1-propionate",68630-95-5," This substance is an amphoteric surfactant and has uses in the Cosmetics industry. Under the cosmetics regulation, animal testing is not allowed on substances used in such products. There is no available in-vivo acute oral toxicity data for this substance and none can be generated. Data has been found relating to similar UVCB substances in published review documents for alkyl imidazolines and imidazoline derivatives suggest that these substances are of low oral toxicity and pose little concern for human health. One set of data suggest that the level may be just below the 2000 mg/kg/bw limit for no classification, where the other set of data suggest that the level is >5000 mg/kg/bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af78d7f8-f9d7-43ba-bcce-b4ba0c35b409/documents/0d8875de-fdf6-47f6-8b81-fc5244c12ecb_7e1e2a3d-70a7-49f5-8e59-c50b16c85c3e.html,,,,,, "Sodium 2-heptyl-2,3-dihydro-3-(2-hydroxyethyl)-1H-imidazole-1-propionate",68630-95-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af78d7f8-f9d7-43ba-bcce-b4ba0c35b409/documents/0d8875de-fdf6-47f6-8b81-fc5244c12ecb_7e1e2a3d-70a7-49f5-8e59-c50b16c85c3e.html,,oral,LD50,"2,000 mg/kg bw",, Sodium 2-hydroxypropane-2-sulphonate,540-92-1," LD50 (oral, rat): >2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c980a35c-6db0-4895-ae8d-86a26bd5c8ef/documents/c0a4261f-9b8e-4c98-82d4-2191702f4fdd_50822842-f1f9-493a-8c62-734f33dcfad5.html,,,,,, Sodium 2-hydroxypropane-2-sulphonate,540-92-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c980a35c-6db0-4895-ae8d-86a26bd5c8ef/documents/c0a4261f-9b8e-4c98-82d4-2191702f4fdd_50822842-f1f9-493a-8c62-734f33dcfad5.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Sodium 2-mercaptoethanolate,37482-11-4, A NOAEL of 19.22 mg/kg bw/day was determined based on read-across data from CAS 60 -24 -2 ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4018f4d9-09ae-4e40-bfe4-5d9a24a95466/documents/IUC5-f95f108c-623b-466d-a813-2efaf984ed5a_cf30f8ec-eb15-411e-95b3-aaa9b884ce73.html,,,,,, Sodium 2-mercaptoethanolate,37482-11-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4018f4d9-09ae-4e40-bfe4-5d9a24a95466/documents/IUC5-f95f108c-623b-466d-a813-2efaf984ed5a_cf30f8ec-eb15-411e-95b3-aaa9b884ce73.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,19.22 mg/kg bw/day,,rat Sodium 2-mercaptoethanolate,37482-11-4,Oral LD50 (OECD401): 98 mg/kg bwInhalation LC50: ca. 2.6 mg/LDermal LD50: 143.36 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4018f4d9-09ae-4e40-bfe4-5d9a24a95466/documents/IUC5-9c60634b-a5cd-4128-ac7f-953209ab28d0_cf30f8ec-eb15-411e-95b3-aaa9b884ce73.html,,,,,, Sodium 2-mercaptoethanolate,37482-11-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4018f4d9-09ae-4e40-bfe4-5d9a24a95466/documents/IUC5-9c60634b-a5cd-4128-ac7f-953209ab28d0_cf30f8ec-eb15-411e-95b3-aaa9b884ce73.html,,oral,LD50,98 mg/kg bw,adverse effect observed, Sodium 2-mercaptoethanolate,37482-11-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4018f4d9-09ae-4e40-bfe4-5d9a24a95466/documents/IUC5-9c60634b-a5cd-4128-ac7f-953209ab28d0_cf30f8ec-eb15-411e-95b3-aaa9b884ce73.html,,dermal,LD50,143.36 mg/kg bw,adverse effect observed, Sodium 2-mercaptoethanolate,37482-11-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4018f4d9-09ae-4e40-bfe4-5d9a24a95466/documents/IUC5-9c60634b-a5cd-4128-ac7f-953209ab28d0_cf30f8ec-eb15-411e-95b3-aaa9b884ce73.html,,inhalation,LC50,2.6 mg/m3,adverse effect observed, Sodium 2-propyne-1-sulphonate,55947-46-1,"Estimated LD50 was considered to be 2616.713623047 mg/kg bw when Sprague-Dawley male and female rats were treated with 2-propyne-1-sulfonic acid, sodium salt orally by gavage ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec8abb40-91ea-4c84-bfcf-344a72fd4a3b/documents/IUC5-2586de8f-a634-48af-945a-3038532763b1_00a93435-2194-4a24-8d5d-fffcd7f269cf.html,,,,,, Sodium 2-propyne-1-sulphonate,55947-46-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec8abb40-91ea-4c84-bfcf-344a72fd4a3b/documents/IUC5-2586de8f-a634-48af-945a-3038532763b1_00a93435-2194-4a24-8d5d-fffcd7f269cf.html,,oral,LD50,"2,616.714 mg/kg bw",no adverse effect observed, Sodium 3-(allyloxy)-2-hydroxypropanesulphonate,52556-42-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): only one study available. a 90 day repeated dose toxicity test has been proposed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca2da616-f869-42ab-903f-a52833f07c9d/documents/IUC5-01674f9f-fdb1-4860-b560-7dfee03d57d8_4934a749-68d2-4e54-97ca-f5e2712dd37e.html,,,,,, Sodium 3-(allyloxy)-2-hydroxypropanesulphonate,52556-42-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca2da616-f869-42ab-903f-a52833f07c9d/documents/IUC5-01674f9f-fdb1-4860-b560-7dfee03d57d8_4934a749-68d2-4e54-97ca-f5e2712dd37e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Sodium 3-(allyloxy)-2-hydroxypropanesulphonate,52556-42-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study is a GLP compliant and has Klimisch score 1. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca2da616-f869-42ab-903f-a52833f07c9d/documents/IUC5-2c14f908-2218-489d-86ba-918580010eaa_4934a749-68d2-4e54-97ca-f5e2712dd37e.html,,,,,, "Sodium 3,5,6-trichloropyridin-2-olate",37439-34-2,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/29310b24-9f2c-4c92-8fd3-0055d6b00712/documents/IUC5-638e6df6-caaf-4884-b71d-63bfc1aabba8_67de34a7-c58a-4b6c-99f6-1a716ab41090.html,Chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat "Sodium 3,5,6-trichloropyridin-2-olate",37439-34-2,Acute toxicity based on chicken ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29310b24-9f2c-4c92-8fd3-0055d6b00712/documents/IUC5-346eacd7-2e4b-48b2-b7f9-364089eeae52_67de34a7-c58a-4b6c-99f6-1a716ab41090.html,,,,,, "Sodium 3-[(1,5-dihydroxy-2-naphthyl)azo]-4-hydroxybenzenesulphonate",2052-25-7,"Repeated administration of Diamantechtrot BT for 28 days and a lifetime exposure to Allura Red did not cause any relevant compound-related adverse effects at any dose. The only effect seen, which could be related to a compound effect is the lowe terminal body weight in female rats dosed with 3604 mg/kg/day. With regard to the present studies, the No Observed Adverse Effect Level (NOAEL) for Mordant Black 9 is considered to be 1000 mg/kg body weight per day for sibacute or chronic exposure. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8724f808-287f-477a-9762-60ab1932616f/documents/IUC5-e54aede0-0be9-400d-9058-7c60f95b28f2_6f6d8ebe-7352-4554-8062-78a405789040.html,,,,,, "Sodium 3-[(1,5-dihydroxy-2-naphthyl)azo]-4-hydroxybenzenesulphonate",2052-25-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8724f808-287f-477a-9762-60ab1932616f/documents/IUC5-e54aede0-0be9-400d-9058-7c60f95b28f2_6f6d8ebe-7352-4554-8062-78a405789040.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Sodium 3-[(1,5-dihydroxy-2-naphthyl)azo]-4-hydroxybenzenesulphonate",2052-25-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8724f808-287f-477a-9762-60ab1932616f/documents/IUC5-047a3df6-2048-4597-8fe6-2a30634267fa_6f6d8ebe-7352-4554-8062-78a405789040.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate,63405-85-6,"Based on the data it can be concluded that the test substance FAT 20004 is found to non-toxic by inhalation and dermal route, but toxic by oral route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/925c91c9-745f-4f91-b7b6-db0ef3e93baa/documents/IUC5-94257b5f-ed5a-4951-aaf2-cb73febd03cd_2db1f0f1-f230-4d71-bf06-34c6569e5e80.html,,,,,, Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate,63405-85-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/925c91c9-745f-4f91-b7b6-db0ef3e93baa/documents/IUC5-94257b5f-ed5a-4951-aaf2-cb73febd03cd_2db1f0f1-f230-4d71-bf06-34c6569e5e80.html,,oral,LD50,428.55 mg/kg bw,adverse effect observed, Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate,63405-85-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/925c91c9-745f-4f91-b7b6-db0ef3e93baa/documents/IUC5-94257b5f-ed5a-4951-aaf2-cb73febd03cd_2db1f0f1-f230-4d71-bf06-34c6569e5e80.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, Sodium 3-[[3-methoxy-4-[(4-methoxyphenyl)azo]phenyl]azo]benzenesulphonate,63405-85-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/925c91c9-745f-4f91-b7b6-db0ef3e93baa/documents/IUC5-94257b5f-ed5a-4951-aaf2-cb73febd03cd_2db1f0f1-f230-4d71-bf06-34c6569e5e80.html,,inhalation,LC50,873.1 mg/m3,no adverse effect observed, Sodium 3-[[4-[(2-ethoxy-5-methylphenyl)azo]-1-naphthyl]azo]benzenesulphonate,68959-00-2, LD0 = 5000 mg/kg LD50 > 5000 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/144059ff-d652-48b8-9d4d-ef22702ee699/documents/ab8e3e8c-38b7-4746-9662-39c70d676df7_be90271c-f378-4ced-b080-0c2212421800.html,,,,,, Sodium 3-[[4-[(2-ethoxy-5-methylphenyl)azo]-1-naphthyl]azo]benzenesulphonate,68959-00-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/144059ff-d652-48b8-9d4d-ef22702ee699/documents/ab8e3e8c-38b7-4746-9662-39c70d676df7_be90271c-f378-4ced-b080-0c2212421800.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Sodium 3-[[4-amino-9,10-dihydro-3-[2-(2-methoxyethoxy)ethoxy]-9,10-dioxo-1-anthryl]amino]-2,4,6-trimethylbenzenesulphonate",70179-77-0," Fo1lowing a range-finding study, a group of ten fasted animals (five males and five females) was given a single oral dose of test material, as a suspension in distilled water at a dose level of 200 mg/kg bodyweight. The animals were observed for fourteen days after the day of dosing and were then killed for gross pathological examination. There were no deaths. No signs of systemic toxicity were noted during the study. All animals showed expected gain in bodyweight during the study. No abnormalities were noted at necropsy. The acute oral median lethal dose (LD50) of the test material in the Sprague-Dawley strain rat was found to be greater than 200 but less than 2000 mg/kg bodyweight, most probaly >300 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96ca37b6-73b6-4392-835d-9a2648c319c6/documents/c4ae005e-5462-4f58-aba1-30c65e8a1c4a_9e79ce68-359d-427c-9b22-f3cee0b929cd.html,,,,,, "Sodium 3-[[4-amino-9,10-dihydro-3-[2-(2-methoxyethoxy)ethoxy]-9,10-dioxo-1-anthryl]amino]-2,4,6-trimethylbenzenesulphonate",70179-77-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96ca37b6-73b6-4392-835d-9a2648c319c6/documents/c4ae005e-5462-4f58-aba1-30c65e8a1c4a_9e79ce68-359d-427c-9b22-f3cee0b929cd.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Sodium 3-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-4-hydroxynaphthalene-1-sulphonate,85721-12-6," Based on the test result for acute oral toxicity, the tested substance is considered as not toxic for oral route with a LD50 > 2000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e385fd7f-9f10-487e-8396-35a0c602df35/documents/56c9eb1c-61eb-45c8-99cf-1679991172e2_6bf988ed-ddd3-42b8-a9fd-25d79705685e.html,,,,,, Sodium 3-[[5-[(diethylamino)sulphonyl]-2-methoxyphenyl]azo]-4-hydroxynaphthalene-1-sulphonate,85721-12-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e385fd7f-9f10-487e-8396-35a0c602df35/documents/56c9eb1c-61eb-45c8-99cf-1679991172e2_6bf988ed-ddd3-42b8-a9fd-25d79705685e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 3-chloro-2-hydroxypropanesulphonate,126-83-0," Oral: OECD 422; 28-day gavage, rats. NOEL >1000 mg/kg (highest dose tested); Reliability = 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e7e548cc-5154-40bd-9d70-8af7f02bafd4/documents/22cd293a-04b2-49b8-a40d-a2a6d8c70d2f_484f41ad-6d30-45ff-b0c3-4dcbcdb21700.html,,,,,, Sodium 3-chloro-2-hydroxypropanesulphonate,126-83-0, Oral: rat LD50: >2000 mg/kg. OECD 420; Reliability = 1 Dermal: Data Waived (the substance does not meet the criteria for classification as acute toxicity by oral route) Inhalation: Data Waived (exposure of humans via inhalation route is not likely) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e7e548cc-5154-40bd-9d70-8af7f02bafd4/documents/0c65e25a-7c3f-40df-8b02-7c5ade59b4c2_484f41ad-6d30-45ff-b0c3-4dcbcdb21700.html,,,,,, "Sodium 3-diazo-3,4-dihydro-4-oxonaphthalene-1-sulphonate",64173-96-2," RA OECD 401: LD50 (rat,oral) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d42042d-b4bf-4c7a-82b4-489615e16cdf/documents/ed5b6894-7d17-4b2f-b00d-86353c929c13_9875d388-24ac-4b57-9aa8-d1cb19704823.html,,,,,, "Sodium 3-diazo-3,4-dihydro-4-oxonaphthalene-1-sulphonate",64173-96-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1d42042d-b4bf-4c7a-82b4-489615e16cdf/documents/ed5b6894-7d17-4b2f-b00d-86353c929c13_9875d388-24ac-4b57-9aa8-d1cb19704823.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Sodium 3-morpholin-4-ylpropane-1-sulfonate,71119-22-7, The LD50 was determined to be > 2000 mg/kg bw in male and female rats after oral treatment with the test item (reference 7.2.1-1). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5683f3a-5605-4ec3-9273-0d469b78b79e/documents/7b99a266-b28a-4448-8403-ccb2742dee82_65abbe71-104f-44fb-9144-04e53e810604.html,,,,,, Sodium 3-morpholin-4-ylpropane-1-sulfonate,71119-22-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b5683f3a-5605-4ec3-9273-0d469b78b79e/documents/7b99a266-b28a-4448-8403-ccb2742dee82_65abbe71-104f-44fb-9144-04e53e810604.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Sodium 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonate,75277-39-3,"In an experimental short-term repeated dose toxicity study under GLP conditions according to OECD Test Guideline No. 407 with rats, the read-across source substance did not induce any adverse effects, the NOEL was 1000 mg/kg bw/d (reference 7.5.1-1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The guideline study using the read-across substance is of high quality and reliable without restrictions. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb1361b3-0073-4b22-9197-6e1779247927/documents/8537a4ae-fe87-4bb4-aeb3-4bd2d1945c4b_22420a39-6cd6-4891-a60e-1867d30bd36a.html,,,,,, Sodium 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonate,75277-39-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cb1361b3-0073-4b22-9197-6e1779247927/documents/8537a4ae-fe87-4bb4-aeb3-4bd2d1945c4b_22420a39-6cd6-4891-a60e-1867d30bd36a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonate,75277-39-3,"In an acute oral toxicity study with rats according to OECD 423, the LD50 value of the read-across substance exceeded 2000 mg/kg bw (reference 7.2.1-1). In an acute dermal toxicity study with rats according to OECD 402, the LD50 value of the read-across substance exceeded 2000 mg/kg bw (reference 7.2.3-1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The guideline study using the read-across substance is of high quality and reliable without restrictions. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The guideline study using the read-across substance is of high quality and reliable without restrictions. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb1361b3-0073-4b22-9197-6e1779247927/documents/eb677b70-c66b-4647-9d6c-de4dfcf4b5b0_22420a39-6cd6-4891-a60e-1867d30bd36a.html,,,,,, Sodium 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonate,75277-39-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb1361b3-0073-4b22-9197-6e1779247927/documents/eb677b70-c66b-4647-9d6c-de4dfcf4b5b0_22420a39-6cd6-4891-a60e-1867d30bd36a.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Sodium 4-(2-hydroxyethyl)piperazin-1-ylethanesulphonate,75277-39-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cb1361b3-0073-4b22-9197-6e1779247927/documents/eb677b70-c66b-4647-9d6c-de4dfcf4b5b0_22420a39-6cd6-4891-a60e-1867d30bd36a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 4-(2-hydroxynaphth-1-ylazo)-3-methylbenzenesulphonate,5850-86-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f231e34-3666-4995-9075-a6176aa5d06c/documents/IUC5-9991e958-73be-4f7e-a669-6787efc18d6b_538dc331-50fe-4dad-9246-9e043e634c79.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium 4-(2-methylprop-2-en-1-yl)benzenesulphonate,1208-67-9," Repeated dose toxicity: via oral route; The NOAEL was considered to be in a dose range of  220.0-1000 mg/kg body weight /day when male and  rats were treated wtih test substance  for chronic study. Repeated inhalation study: According to Annex IX of the REACH regulation, testing by the inhalation route is appropriate only if exposure of humans via inhalation is likely. Taking into account the low vapour pressure of the substance 4-(2-methylprop-2-en-1-yl) benzenesulfonate( 1208-67-9) which is reported as 0.0028427338 mmHg at 25 C. Thus, exposure to inhalable dust, mist and vapour of the chemical 4-(2-methylprop-2-en-1-yl) benzenesulfonate is highly unlikely. Therefore this study is considered for waiver. Repeated dermal study; The acute toxicity value for4-(2-methylprop-2-en-1-yl) benzenesulfonate( 1208-67-9)  (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that 4-(2-methylprop-2-en-1-yl) benzenesulfonate shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that 4-(2-methylprop-2-en-1-yl) benzenesulfonate shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f61b8e77-0ca4-492d-950c-8221b20ae231/documents/9c20f3ff-a3c3-4ddb-b9b0-71b8b89a737d_bbacb16e-9d4f-4773-8110-bc081a0f49c2.html,,,,,, Sodium 4-(2-methylprop-2-en-1-yl)benzenesulphonate,1208-67-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f61b8e77-0ca4-492d-950c-8221b20ae231/documents/9c20f3ff-a3c3-4ddb-b9b0-71b8b89a737d_bbacb16e-9d4f-4773-8110-bc081a0f49c2.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium 4-(2-methylprop-2-en-1-yl)benzenesulphonate,1208-67-9," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is >5000 mg/kg bw. The study concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity. Acute Inhalation Toxicity: The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 3.79E-10 Pa. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.  Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats and rabbits for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f61b8e77-0ca4-492d-950c-8221b20ae231/documents/53042ebb-bb5f-4b67-8029-50760d3d10d0_bbacb16e-9d4f-4773-8110-bc081a0f49c2.html,,,,,, Sodium 4-(2-methylprop-2-en-1-yl)benzenesulphonate,1208-67-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f61b8e77-0ca4-492d-950c-8221b20ae231/documents/53042ebb-bb5f-4b67-8029-50760d3d10d0_bbacb16e-9d4f-4773-8110-bc081a0f49c2.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium 4-(2-methylprop-2-en-1-yl)benzenesulphonate,1208-67-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f61b8e77-0ca4-492d-950c-8221b20ae231/documents/53042ebb-bb5f-4b67-8029-50760d3d10d0_bbacb16e-9d4f-4773-8110-bc081a0f49c2.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate,6406-56-0," Based on the prediction done using the OECD QSAR toolbox version 3.4 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for Sodium 4 -(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate. The study assumed the use of male and female Sprage Dawley rats in a chronic toxicity study. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Level (NOAEL) for Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate is predicted to be 574.166687012 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b09c093-10cb-462c-9f68-ad377a0bbb82/documents/876753c7-db94-4589-b896-a321882a2fba_bbf9b0ad-3b75-4ce0-8812-546a2e1aa62d.html,,,,,, Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate,6406-56-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3b09c093-10cb-462c-9f68-ad377a0bbb82/documents/876753c7-db94-4589-b896-a321882a2fba_bbf9b0ad-3b75-4ce0-8812-546a2e1aa62d.html,Chronic toxicity – systemic effects,oral,NOAEL,574.167 mg/kg bw/day,,rat Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate,6406-56-0," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value for target substance C.I. Acid Red 151(CAS NO: 6406-56-0) was considered to be 7736 mg/kg bw,and for differentstudies available on the structurally similar read across substance Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate(2783-94-0) was considered to be >6000 mg/kg bw ;for FD & C Red NO. 40 (25956-17-6) was considered to be >10000 mg/kg bw and for Disodium 5-amino-4-hydroxy-3-(phenylazo) naphthalene-2, 7-disulphonate (CAS No. 3567-66-6) was considered to be 5000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, C.I. Acid Red 151(CAS NO: 6406-56-0) cannot be classified for acute oral toxicity. Acute Inhalation Toxicity:  Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate (6406-56-0) has very low vapor pressure (5.19E-021 Pa.), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver. Acute Dermal Toxicity: In Acute dermal toxicity, LD50 value was predicted based on OECD QSAR toolbox for target substance Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate (6406-56-0) was estimated to be 6184.56 mg/kg bw,and for differentstudies available on structurally similar read across substance Disodium 5-amino-4-hydroxy-3-(phenylazo) naphthalene-2, 7-disulphonate (CAS No. 3567-66-6) was considered to be >2000 mg/kg bw and for Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate (CAS No. 2519-30-4) was considered to be >2000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate (6406-56-0) cannot be classified for acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b09c093-10cb-462c-9f68-ad377a0bbb82/documents/657b3c0f-b6e9-4bba-972a-9c3b3bc2085d_bbf9b0ad-3b75-4ce0-8812-546a2e1aa62d.html,,,,,, Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate,6406-56-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b09c093-10cb-462c-9f68-ad377a0bbb82/documents/657b3c0f-b6e9-4bba-972a-9c3b3bc2085d_bbf9b0ad-3b75-4ce0-8812-546a2e1aa62d.html,,oral,LD50,"7,736 mg/kg bw",no adverse effect observed, Sodium 4-(4-(2-hydroxynaphthalenylazo)phenylazo)benzenesulphonate,6406-56-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b09c093-10cb-462c-9f68-ad377a0bbb82/documents/657b3c0f-b6e9-4bba-972a-9c3b3bc2085d_bbf9b0ad-3b75-4ce0-8812-546a2e1aa62d.html,,dermal,LD50,"6,184.56 mg/kg bw",no adverse effect observed, Sodium 4(or 5)-methyl-1H-benzotriazolide,64665-57-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study is a well conducted GLP-Study following the OECD-Guideline ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/610e1529-8538-4dcb-a48d-a3308b468471/documents/01064ae0-a486-4a37-827e-de3ddb827603_91340065-610f-4b0a-823a-3bfcd9d84ffc.html,,,,,, Sodium 4(or 5)-methyl-1H-benzotriazolide,64665-57-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/610e1529-8538-4dcb-a48d-a3308b468471/documents/01064ae0-a486-4a37-827e-de3ddb827603_91340065-610f-4b0a-823a-3bfcd9d84ffc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Sodium 4(or 5)-methyl-1H-benzotriazolide,64665-57-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): There are two studies available, the key study is rated Klimisch 1, the supporting study Klimisch 2. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The study is performed similar to OECD Guideline and rated Klimisch 2 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/610e1529-8538-4dcb-a48d-a3308b468471/documents/IUC5-a1d0a47d-a721-4e85-ad35-9e63ca69e06e_91340065-610f-4b0a-823a-3bfcd9d84ffc.html,,,,,, Sodium 4(or 5)-methyl-1H-benzotriazolide,64665-57-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/610e1529-8538-4dcb-a48d-a3308b468471/documents/IUC5-a1d0a47d-a721-4e85-ad35-9e63ca69e06e_91340065-610f-4b0a-823a-3bfcd9d84ffc.html,,oral,LD50,735 mg/kg bw,adverse effect observed, Sodium 4(or 5)-methyl-1H-benzotriazolide,64665-57-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/610e1529-8538-4dcb-a48d-a3308b468471/documents/IUC5-a1d0a47d-a721-4e85-ad35-9e63ca69e06e_91340065-610f-4b0a-823a-3bfcd9d84ffc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sodium 4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonate",69762-08-9, Non toxic by oral and dermal route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d62a1df-0ef9-4a7b-8c78-de5d4eb48be8/documents/a01243b3-c127-445a-a0f0-217328209a5d_fc76a98c-28c5-45b2-9f84-2e8babd75465.html,,,,,, "Sodium 4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonate",69762-08-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d62a1df-0ef9-4a7b-8c78-de5d4eb48be8/documents/a01243b3-c127-445a-a0f0-217328209a5d_fc76a98c-28c5-45b2-9f84-2e8babd75465.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "Sodium 4-[(5-amino-3-methyl-1-phenyl-1H-pyrazol-4-yl)azo]-2,5-dichlorobenzenesulphonate",69762-08-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d62a1df-0ef9-4a7b-8c78-de5d4eb48be8/documents/a01243b3-c127-445a-a0f0-217328209a5d_fc76a98c-28c5-45b2-9f84-2e8babd75465.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Sodium 4-[[3-(acetylamino)phenyl]amino]-1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",70571-81-2," The 29-day oral administration of the structural analogue at dose levels of 62.5, 250, and 1000 mg/kg body weight/day did not result in any test substance-related toxicity. Consequently, the ""no toxic effect level"" was considered to be 1000 mg/kg bw/day or above. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b1331775-c2bb-4e1b-99bd-5723eec6979e/documents/a7b7d9c6-cf2a-4eb7-b7ac-2f1733f66175_04526258-811a-41e8-8833-ddc053650748.html,,,,,, "Sodium 4-[[3-(acetylamino)phenyl]amino]-1-amino-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",70571-81-2, The acute oral toxicity was tested in rats at dose levels of 5000 mg/kg bw. No deaths or signs of toxicity was observed in these studies. The structural analogue was tested in a dermal acute toxicity study at a limit dose of 2000 mg/kg bw in male and female rats. No deaths or signs of toxicity was observed in this study. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b1331775-c2bb-4e1b-99bd-5723eec6979e/documents/5c86fa04-8ac4-4c08-9c31-6787ba1cecf6_04526258-811a-41e8-8833-ddc053650748.html,,,,,, Sodium 4-[4-[[2-methyl-4-[[(p-tolyl)sulphonyl]oxy]phenyl]azo]anilino]-3-nitrobenzenesulphonate,12220-06-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/89b53094-7016-49c7-95f9-27c66d0f1075/documents/4b01b20d-5276-4c05-802f-a0ee4aace556_79b81421-6320-4b3b-be6a-808ed139930f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium 4-[4-[[2-methyl-4-[[(p-tolyl)sulphonyl]oxy]phenyl]azo]anilino]-3-nitrobenzenesulphonate,12220-06-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/89b53094-7016-49c7-95f9-27c66d0f1075/documents/2a8c117b-1016-4904-a8ec-3b99b9417969_79b81421-6320-4b3b-be6a-808ed139930f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sodium 4-chloro-3-[4-[[5-chloro-2-(2-chlorophenoxy)phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonate",72479-28-8,Oral toxicity: LD50 > 15000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dc34761-0446-4088-bdd6-aee6eb03a722/documents/7445ad6b-9395-4323-bfec-f383746d636c_f77822ab-35d9-46dc-8e11-3e2be2553e57.html,,,,,, "Sodium 4-chloro-3-[4-[[5-chloro-2-(2-chlorophenoxy)phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonate",72479-28-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dc34761-0446-4088-bdd6-aee6eb03a722/documents/7445ad6b-9395-4323-bfec-f383746d636c_f77822ab-35d9-46dc-8e11-3e2be2553e57.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, Sodium 4-chloro-3-nitrobenzenesulphonate,17691-19-9," Acute Oral Toxicity: The lethal concentration (LD50) value for acute oral toxicity test was considered to be >5000 mg/kg bw ,when 5 male and 5 female Wistar (SPF cpB) rats were treated with Sodium 4-chloro-3-nitrobenzenesulphonate (17691-19-9) orally. Thus, comparing this value with the criteria of CLPregulation,Sodium 4-chloro-3-nitrobenzenesulphonate (17691-19-9)can be “Not classified” for Acute Oral Toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eabdcc9b-2f35-4054-a261-8aa7b91bf23a/documents/584c9ef2-1416-410d-8b7b-195a68270363_fad4425b-faec-467c-9542-dc40be6cbdba.html,,,,,, Sodium 4-chloro-3-nitrobenzenesulphonate,17691-19-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eabdcc9b-2f35-4054-a261-8aa7b91bf23a/documents/584c9ef2-1416-410d-8b7b-195a68270363_fad4425b-faec-467c-9542-dc40be6cbdba.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium 4-hydroxybenzenesulphonate,825-90-1,"Acute toxicity: oral The acute toxicity potential of Sodium 4 -hydroxybenzenesulfonate was evaluated in a study performed according to OECD Guideline 420. Following a sighting test at dose levels of 300 mg/kg bw and 2000 mg/kg bw, a further group of four fasted female Wistar rats was given a single oral dose of test item, as a solution in distilled water, at a dose level of 2000 mg/kg bw. There were no deaths and no signs of systemic toxicity recorded. All animals treated at a dose level of 2000 mg/kg bw showed expected gains in body weight. The animal treated at a dose level of 300 mg/kg bw showed body weight loss during the first week but expected gain in body weight during the second week. No abnormalities were noted at necropsy. Hence, based on the above findings, the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bw (Globally Harmonized Classification System-Unclassified).   Acute toxicity: inhalation Currently no study to assess the acute inhalation toxicity potential of Sodium 4-hydroxybenzenesulfonateis available. However, the vapour pressure for Sodium 4-hydroxybenzenesulfonateis expected to be low owing to the high melting point (>350 °C),hence, it is considered to have low volatility. The low partition coefficient of-2.79 and large particle size (mass median diameter 323.81 μm), again point to poor absorption across the respiratory tract. Sodium 4-hydroxybenzenesulfonatewas found to have high water solubility (92400mg/L), hence, the inhaled dust may be retained within the mucus of the respiratory tract, thereby limiting the absorption. The use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Further, no systemic effects were observed in the oral toxicity study withSodium 4-hydroxybenzenesulfonate. Hence, no toxicity is expected on acute inhalation exposure of the substance and testing by the inhalation route was considered scientifically not necessary. Acute toxicity: dermal Currently no study to assess the acute dermal toxicity potential of Sodium 4 -hydroxybenzenesulfonate is available. However, owing to the high water solubility (92400 mg/l) and the low partition coefficient value (-2.79), Sodium 4 -hydroxybenzenesulfonate is considered too hydrophilic to cross the lipid rich environment of the stratum corneum. Hence, dermal uptake for the substance will be low. Further, no systemic effects were observed in the skin irritation study and the oral toxicity study with the substance itself. Hence, no toxicity is expected on acute dermal exposure of Sodium 4 -hydroxybenzenesulfonate and testing by the dermal route was considered not necessary. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): High quality GLP study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c3cbc20-fcc3-41f8-bb16-820c21901cde/documents/9067b22d-dc39-441f-ba21-ed74f631df3e_0ce2ed6b-e980-43ee-a409-b9bf808ca880.html,,,,,, Sodium 4-hydroxybenzenesulphonate,825-90-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c3cbc20-fcc3-41f8-bb16-820c21901cde/documents/9067b22d-dc39-441f-ba21-ed74f631df3e_0ce2ed6b-e980-43ee-a409-b9bf808ca880.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 4-morpholin-1-ylethylsulphonate,71119-23-8,"In a GLP-study according to OECD TG 423 (acute class method) with rats, the LD50 of the source substance was determined as > 2000 mg/kg bw (reference 7.2.1 -1). The study was performed with the hydrate form of the substance (CAS 1266615-59-1). However, same results are expected for the anhydrous form of the source substance (CAS 4432-31-9) and also for the target substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): OECD TG 423, GLP ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a150bd5-7318-4c26-8dab-21f3a648cc41/documents/2198d6f9-5e0b-4c08-bdc2-d5e76c691e06_ab91b4f6-3f3c-4418-acec-aa93374183e5.html,,,,,, Sodium 4-morpholin-1-ylethylsulphonate,71119-23-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a150bd5-7318-4c26-8dab-21f3a648cc41/documents/2198d6f9-5e0b-4c08-bdc2-d5e76c691e06_ab91b4f6-3f3c-4418-acec-aa93374183e5.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Sodium 4-vinylbenzenesulphonate,2695-37-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The data are available from a GLP accredited study conducted in compliance with a current internationally recognised guideline (OECD). The study is assigned a quality of K1. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a52eec4-6ef4-4278-b67f-da6263596361/documents/IUC5-600f2eba-36af-45f9-95ef-55dd31a9be23_8a324765-45a8-464d-833f-052edd2ec00e.html,,,,,, Sodium 4-vinylbenzenesulphonate,2695-37-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a52eec4-6ef4-4278-b67f-da6263596361/documents/IUC5-600f2eba-36af-45f9-95ef-55dd31a9be23_8a324765-45a8-464d-833f-052edd2ec00e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Sodium 4-vinylbenzenesulphonate,2695-37-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The data have been accumulated according to a clearly defined test method but not in compliance with GLP. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Study was conducted to GLP, but according to an older study guideline. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a52eec4-6ef4-4278-b67f-da6263596361/documents/IUC5-29031085-ea84-4ab2-9570-710ec0b97890_8a324765-45a8-464d-833f-052edd2ec00e.html,,,,,, Sodium 4-vinylbenzenesulphonate,2695-37-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a52eec4-6ef4-4278-b67f-da6263596361/documents/IUC5-29031085-ea84-4ab2-9570-710ec0b97890_8a324765-45a8-464d-833f-052edd2ec00e.html,,oral,LD50,"6,400 mg/kg bw",no adverse effect observed, Sodium 4-vinylbenzenesulphonate,2695-37-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a52eec4-6ef4-4278-b67f-da6263596361/documents/IUC5-29031085-ea84-4ab2-9570-710ec0b97890_8a324765-45a8-464d-833f-052edd2ec00e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 5-(aminosulphonyl)-2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl]benzoxazolesulphonate,93859-32-6," Prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound Sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2,3-dihydro-1,3-benzoxazole-2-sulfonat... (93859-32-6).The study assumed the use of male and female Wistar rats in chronic study of 24month. No significant alterations were noted at the dose level of 675.20mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for Sodium 2-[7-(diethylamino)-2-oxo-2H-chromen-3-yl]-5-sulfamoyl-2 ,3-dihydro-1,3 benzoxazol-2-sulfonat... (93859-32-6) is considered to be 675.20mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7bcb2b4-7541-4baa-9d17-7bd7b46df4c9/documents/71bc3e1c-3040-4781-9484-154c2a38a851_69e38bd7-7199-4b72-9d73-29fc1627597f.html,,,,,, Sodium 5-(aminosulphonyl)-2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl]benzoxazolesulphonate,93859-32-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c7bcb2b4-7541-4baa-9d17-7bd7b46df4c9/documents/71bc3e1c-3040-4781-9484-154c2a38a851_69e38bd7-7199-4b72-9d73-29fc1627597f.html,Chronic toxicity – systemic effects,oral,NOAEL,675.2 mg/kg bw/day,,rat Sodium 5-(aminosulphonyl)-2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl]benzoxazolesulphonate,93859-32-6," Acute oral toxicity: Acute oral toxicity dose (LD50) of Sodium 5-(aminosulphonyl)-2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl] benzoxazolesulphonate (CAS no: 93859-32-6) was predicted based on OECD QSAR toolbox 3962 mg/kg bw and different studies available on structurally similar read across substances Aluminium, 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid complex (CAS No. 16521-38-3) 5000 mg/kg bw and Disodium 5,5’-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate (CAS No. 860-22-0) 5000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Sodium 5-(aminosulphonyl)-2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl] benzoxazolesulphonate can be classified as category V of acute oral toxicity. Acute Inhalation toxicity:  Sodium 5-(aminosulphonyl)-2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl] benzoxazolesulphonate (CAS no: 93859-32-6) has very low vapour pressure 2.92E-019 Pa. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for Sodium 5-(aminosulphonyl)-2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl] benzoxazolesulphonate (CAS no: 93859-32-6) was predicted based on OECD QSAR toolbox 29969 mg/kg bwand differentstudies available for the structurally similar read across substance Aluminium, 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid complex (CAS No. 16521-38-3) >2000 mg/kg bw and Disodium 5,5’-(2-(1,3-dihydro-3-oxo-2H-indazol-2-ylidene)-1,2-dihydro-3H-indol-3-one)disulphonate (CAS No. 860-22-0) >2000 mg/kg bw. All these studies concluded that the LD50 value is>2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Sodium 5-(aminosulphonyl)-2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl] benzoxazolesulphonate can be classified as category V of acute dermal toxicity.  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7bcb2b4-7541-4baa-9d17-7bd7b46df4c9/documents/IUC5-cfde329e-19f4-474e-b34e-975a1a47faa7_69e38bd7-7199-4b72-9d73-29fc1627597f.html,,,,,, Sodium 5-(aminosulphonyl)-2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl]benzoxazolesulphonate,93859-32-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7bcb2b4-7541-4baa-9d17-7bd7b46df4c9/documents/IUC5-cfde329e-19f4-474e-b34e-975a1a47faa7_69e38bd7-7199-4b72-9d73-29fc1627597f.html,,oral,LD50,"3,962 mg/kg bw",no adverse effect observed, Sodium 5-(aminosulphonyl)-2-[7-(diethylamino)-2-oxo-2H-1-benzopyran-3-yl]benzoxazolesulphonate,93859-32-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7bcb2b4-7541-4baa-9d17-7bd7b46df4c9/documents/IUC5-cfde329e-19f4-474e-b34e-975a1a47faa7_69e38bd7-7199-4b72-9d73-29fc1627597f.html,,dermal,LD50,"29,969 mg/kg bw",no adverse effect observed, Sodium 5-[[4-acetamido-2-(trifluoromethyl)phenyl]azo]-6-amino-4-hydroxynaphthalene-2-sulphonate,75198-93-5, The test item has a LD50 >5000 mg/kg bw via oral exposure (gavage). The LD50 (oral) was determined in two OECD 401 studies with male and female rats. No other adverse effects were observed. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e30b5ffc-6483-4b3b-9203-7177ef5db660/documents/5dba9a32-c7ae-4ea4-b656-3cd3b024fd7c_84fd11c0-1901-46d1-be00-b58d228c1730.html,,,,,, Sodium 5-methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyrazinecarboxamidate,84522-34-9, Oral: The oral LD50 value of the test item in Wistar rat was established to exceed 2000 mg/kg bw. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7908964-319f-4753-825b-da46b0bd964e/documents/5ad22d5f-2b7f-4e6e-919a-4e39a80b02d3_2f62f1c4-a410-4d30-aab2-5ca5f1ce3030.html,,,,,, Sodium 5-methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyrazinecarboxamidate,84522-34-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7908964-319f-4753-825b-da46b0bd964e/documents/5ad22d5f-2b7f-4e6e-919a-4e39a80b02d3_2f62f1c4-a410-4d30-aab2-5ca5f1ce3030.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 5-N-butylbenzotriazole,118685-34-0,"Acute Oral ToxicityThe study was conducted in accordance wilth under Annex V of the EEC direcetíve 79/831/EEC, Part B Methods for determínation of toxicity, Method B1 Acute OraI Toxicity, and the OECD guideline for Testing of Chemicals No. 401 ""Acute OraI Toxicity"" ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33c67f04-999d-468a-9f1c-3135a8fea76a/documents/IUC5-353e3424-6cb8-4102-a36e-d09a2419a607_8a07731e-8662-436f-b701-c5fed6a1eabe.html,,,,,, Sodium 5-N-butylbenzotriazole,118685-34-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33c67f04-999d-468a-9f1c-3135a8fea76a/documents/IUC5-353e3424-6cb8-4102-a36e-d09a2419a607_8a07731e-8662-436f-b701-c5fed6a1eabe.html,,oral,LD50,"1,400 mg/kg bw",adverse effect observed, Sodium 5-oxo-DL-prolinate,54571-67-4,"Repeat dose toxicity oral: male (rat) NOAEL 7200 mg/kg bw/day, female (rat) NOAEL 8200 mg/kg bw/day, similar to OECD 408, Ishii 1992. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1fe70000-25af-40f9-9977-de0b68d0512d/documents/IUC5-9acc2c46-30d9-44d3-ae07-5c4f44a5f107_a10a63f1-bc47-41a8-93fa-62191c8e596f.html,,,,,, Sodium 5-oxo-DL-prolinate,54571-67-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1fe70000-25af-40f9-9977-de0b68d0512d/documents/IUC5-9acc2c46-30d9-44d3-ae07-5c4f44a5f107_a10a63f1-bc47-41a8-93fa-62191c8e596f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"7,200 mg/kg bw/day",,rat Sodium 5-oxo-DL-prolinate,54571-67-4,"ACUTE ORAL: LD50 > 2000 mg/kg , OECD 423, Kiss (2012) (read across)ACUTE DERMAL: LD50 > 2000 mg/kg, OECD 402, Kiss (2012) (read across) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fe70000-25af-40f9-9977-de0b68d0512d/documents/IUC5-2b2de61f-ad4d-4a0e-92f3-bdba6f5073d9_a10a63f1-bc47-41a8-93fa-62191c8e596f.html,,,,,, "Sodium 6,14-diethyl-1,1,1,2,2,18,18,19,19,19-decafluoro-8,12-dioxo-10-({[1-(2,2,3,3,3-pentafluoropropoxy)butan-2-yl]oxy}carbonyl)-4,7,13,16-tetraoxanonadecane-9-sulfonate",1472634-24-4," Repeated dose, oral, 28 d, rat, OECD 407, GLP, NOAEL = 1000 mg/kg bw/d, NOEL = 100 mg/kg bw/d ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/77449223-ace4-41c1-a1a9-707dc8219648/documents/9033633b-ce56-4b1b-9a7c-914a06a488bf_b02034e9-868b-4cb3-b344-68802430caa3.html,,,,,, "Sodium 6,14-diethyl-1,1,1,2,2,18,18,19,19,19-decafluoro-8,12-dioxo-10-({[1-(2,2,3,3,3-pentafluoropropoxy)butan-2-yl]oxy}carbonyl)-4,7,13,16-tetraoxanonadecane-9-sulfonate",1472634-24-4,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/77449223-ace4-41c1-a1a9-707dc8219648/documents/9033633b-ce56-4b1b-9a7c-914a06a488bf_b02034e9-868b-4cb3-b344-68802430caa3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Sodium 6,14-diethyl-1,1,1,2,2,18,18,19,19,19-decafluoro-8,12-dioxo-10-({[1-(2,2,3,3,3-pentafluoropropoxy)butan-2-yl]oxy}carbonyl)-4,7,13,16-tetraoxanonadecane-9-sulfonate",1472634-24-4," Key, acute toxicity, limit test, rat, oral (gavage), OECD 423, GLP: LD50 > 2000 mg/kg bw Key, acute toxicity, limit test, rat, inhalation, aerosol, OECD 436, GLP: LD50 > 5500 mg/m3 air Key, acute toxicity, limit test, rat, dermal, OECD 402, GLP: LD50 > 2000 mg/kg ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77449223-ace4-41c1-a1a9-707dc8219648/documents/0c3e4cf5-f1de-457e-9296-9f81d0f02597_b02034e9-868b-4cb3-b344-68802430caa3.html,,,,,, "Sodium 6,14-diethyl-1,1,1,2,2,18,18,19,19,19-decafluoro-8,12-dioxo-10-({[1-(2,2,3,3,3-pentafluoropropoxy)butan-2-yl]oxy}carbonyl)-4,7,13,16-tetraoxanonadecane-9-sulfonate",1472634-24-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77449223-ace4-41c1-a1a9-707dc8219648/documents/0c3e4cf5-f1de-457e-9296-9f81d0f02597_b02034e9-868b-4cb3-b344-68802430caa3.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Sodium 6,14-diethyl-1,1,1,2,2,18,18,19,19,19-decafluoro-8,12-dioxo-10-({[1-(2,2,3,3,3-pentafluoropropoxy)butan-2-yl]oxy}carbonyl)-4,7,13,16-tetraoxanonadecane-9-sulfonate",1472634-24-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77449223-ace4-41c1-a1a9-707dc8219648/documents/0c3e4cf5-f1de-457e-9296-9f81d0f02597_b02034e9-868b-4cb3-b344-68802430caa3.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Sodium 6,14-diethyl-1,1,1,2,2,18,18,19,19,19-decafluoro-8,12-dioxo-10-({[1-(2,2,3,3,3-pentafluoropropoxy)butan-2-yl]oxy}carbonyl)-4,7,13,16-tetraoxanonadecane-9-sulfonate",1472634-24-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77449223-ace4-41c1-a1a9-707dc8219648/documents/0c3e4cf5-f1de-457e-9296-9f81d0f02597_b02034e9-868b-4cb3-b344-68802430caa3.html,,inhalation,discriminating conc.,"5,500 mg/m3",no adverse effect observed, Sodium 6-amino-4-hydroxy-5-[[2-(phenylsulphonyl)phenyl]azo]naphthalene-2-sulphonate,6245-60-9, LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/822e7fa4-f37c-4c9f-aa5a-bcdddad2c0f7/documents/88e3457a-becb-4188-af38-f134aa821791_759e5541-9678-4854-8b99-59c4261ad232.html,,,,,, Sodium 6-amino-4-hydroxy-5-[[2-(trifluoromethyl)phenyl]azo]naphthalene-2-sulphonate,67786-14-5, The test item has a LD50 >2000 mg/kg bw via oral exposure (gavage). The LD50 (oral) was determined in two OECD 401 studies with male and female rats. No other adverse effects were observed. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b07187b7-af65-4570-9cc4-8d465f07616e/documents/4ca1d4ed-30e8-4199-aa3d-bce5c2fd0b1a_6987c3eb-6df9-4129-b696-3e2c504752a2.html,,,,,, Sodium 6-amino-5-[[2-[(cyclohexylmethylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate,32846-21-2,The NOAEL of the test substance is 1000 mg/kg bw/day for male and females rats when administered orally by gavage. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/216c91c4-4f86-418a-a84a-2d753e8f60fa/documents/IUC5-10124bc9-f101-488d-b3a4-29c363707e10_dce6896f-e58b-492f-9adc-875b055d0fde.html,,,,,, Sodium 6-amino-5-[[2-[(cyclohexylmethylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate,32846-21-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/216c91c4-4f86-418a-a84a-2d753e8f60fa/documents/IUC5-10124bc9-f101-488d-b3a4-29c363707e10_dce6896f-e58b-492f-9adc-875b055d0fde.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium 6-amino-5-[[2-[(cyclohexylmethylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate,32846-21-2,"The oral LD50 for Acid Red 361 was found to be >5000 mg/kg bw, while the dermal LD50 was >2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/216c91c4-4f86-418a-a84a-2d753e8f60fa/documents/IUC5-5743c1ff-2fe1-4a6c-a343-f0f49db08d08_dce6896f-e58b-492f-9adc-875b055d0fde.html,,,,,, Sodium 6-amino-5-[[2-[(cyclohexylmethylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate,32846-21-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/216c91c4-4f86-418a-a84a-2d753e8f60fa/documents/IUC5-5743c1ff-2fe1-4a6c-a343-f0f49db08d08_dce6896f-e58b-492f-9adc-875b055d0fde.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium 6-amino-5-[[2-[(cyclohexylmethylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate,32846-21-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/216c91c4-4f86-418a-a84a-2d753e8f60fa/documents/IUC5-5743c1ff-2fe1-4a6c-a343-f0f49db08d08_dce6896f-e58b-492f-9adc-875b055d0fde.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 6-amino-5-[[2-[(ethylphenylamino)sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate,70865-30-4, Oral LD50 (rat) > 2000 mg/kg bw Dermal LD50 (rat) > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd11827e-e19f-4f97-88cd-ab36130494d8/documents/53891fb2-f6a4-4cca-9ccb-107e011b9adb_65a1d62c-6380-416f-8fa1-c998c6fae7fd.html,,,,,, Sodium 6-amino-5-[[4-chloro-2-(trifluoromethyl)phenyl]azo]-4-hydroxynaphthalene-2-sulphonate,57741-47-6," Prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose oral toxicity was predicted for the test compound Sodium 6-amino-5-{[4-chloro-2-(trifluoromethyl)phenyl]diazenyl} -4-hydroxynaphthalene -2-sulfonate (57741-47-6). The study assumed the use of male and female Crj: CD(SD) in chronic study of 90days. No significant alterations were noted at the dose level of 667.080mg/Kg bw/day. The predicted No Observed Adverse Effect Level (NOAEL) for compound Sodium 6-amino-5-{[4-chloro-2-(trifluoromethyl) phenyl]diazenyl}-4-hydroxynaphthalene-2-sulfonate is considered to be 450.2mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d082ba6-80f3-4270-8d4b-515a44dd90fe/documents/2db00045-7060-45b3-bb6a-8ab5302fdb66_e3aef5da-04cf-46d7-b0a8-8909a7775d4c.html,,,,,, Sodium 6-amino-5-[[4-chloro-2-(trifluoromethyl)phenyl]azo]-4-hydroxynaphthalene-2-sulphonate,57741-47-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0d082ba6-80f3-4270-8d4b-515a44dd90fe/documents/2db00045-7060-45b3-bb6a-8ab5302fdb66_e3aef5da-04cf-46d7-b0a8-8909a7775d4c.html,Chronic toxicity – systemic effects,oral,NOAEL,450.2 mg/kg bw/day,,rat Sodium 6-amino-5-[[4-chloro-2-(trifluoromethyl)phenyl]azo]-4-hydroxynaphthalene-2-sulphonate,57741-47-6," Acute oral toxicity:  Acute oral toxicity dose (LD50) of Sodium 6-amino-5-[[4-chloro-2-(trifluoromethyl)phenyl]azo]-4-hydroxynaphthalene-2-sulphonate (CAS no: 57741-47-6) was predicted based on OECD QSAR toolbox 6216 mg/kg bw and different studies available on structurally similar read across substances Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (CAS No. 3567-66-6) >2000 mg/kg bw and Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (CAS no: 3734-67-6) >2000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Sodium 6-amino-5-[[4-chloro-2-(trifluoromethyl)phenyl]azo]-4-hydroxynaphthalene-2-sulphonate cannot be classified for acute oral toxicity. Acute Inhalation toxicity:  Sodium 6-amino-5-[[4-chloro-2-(trifluoromethyl)phenyl]azo]-4-hydroxynaphthalene-2-sulphonate (CAS no: 57741-47-6) has very low vapour pressure (1.559E-19 Pa at 25°C), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver. Acute Dermal toxicity:  Acute Dermal toxicity dose (LD50) for Sodium 6-amino-5-[[4-chloro-2-(trifluoromethyl)phenyl]azo]-4-hydroxynaphthalene-2-sulphonate (CAS no: 57741-47-6) was predicted based on OECD QSAR toolbox 3204 mg/kg bw and different studies available for the structurally similar read across substances Disodium 5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (CAS no: 3567-66-6) >2000 mg/kg bw and Disodium 5-acetylamino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonate (CAS no: 3734-67-6) >2000 mg/kg bw. All these studies concluded that the LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Sodium 6-amino-5-[[4-chloro-2-(trifluoromethyl)phenyl]azo]-4-hydroxynaphthalene-2-sulphonate cannot be classified for acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d082ba6-80f3-4270-8d4b-515a44dd90fe/documents/adb8a68b-0a2b-410f-9c8c-ef6a90f13915_e3aef5da-04cf-46d7-b0a8-8909a7775d4c.html,,,,,, Sodium 6-amino-5-[[4-chloro-2-(trifluoromethyl)phenyl]azo]-4-hydroxynaphthalene-2-sulphonate,57741-47-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d082ba6-80f3-4270-8d4b-515a44dd90fe/documents/adb8a68b-0a2b-410f-9c8c-ef6a90f13915_e3aef5da-04cf-46d7-b0a8-8909a7775d4c.html,,oral,LD50,"6,216 mg/kg bw",no adverse effect observed, Sodium 6-amino-5-[[4-chloro-2-(trifluoromethyl)phenyl]azo]-4-hydroxynaphthalene-2-sulphonate,57741-47-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d082ba6-80f3-4270-8d4b-515a44dd90fe/documents/adb8a68b-0a2b-410f-9c8c-ef6a90f13915_e3aef5da-04cf-46d7-b0a8-8909a7775d4c.html,,dermal,LD50,"3,204 mg/kg bw",no adverse effect observed, "Sodium 6-amino-5-[[4-chloro-3-[[(2,4-dimethylphenyl)amino]sulphonyl]phenyl]azo]-4-hydroxynaphthalene-2-sulphonate",71873-39-7,"Read-across, KS, 1993, OECD401: Oral LD50 (rat) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20e68230-3e50-42b4-a104-d957dcb3f8f5/documents/f9db7e9a-ab11-4c15-ad24-f1b63b8be716_22893bec-3b6b-45e5-9e68-0f2208f8b7f6.html,,,,,, "Sodium 6-diazo-5,6-dihydro-5-oxonaphthalene-1-sulphonate",2657-00-3," OECD 401: LD50 (oral, rat) > 2000 mg/kg bw ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bab55616-1eca-48a1-9328-ae7b148c489a/documents/bbeec59a-4842-411f-8757-698bb6552391_e2ca5a14-6b19-4d3e-ad18-33e41e7ef87f.html,,,,,, "Sodium 6-diazo-5,6-dihydro-5-oxonaphthalene-1-sulphonate",2657-00-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bab55616-1eca-48a1-9328-ae7b148c489a/documents/bbeec59a-4842-411f-8757-698bb6552391_e2ca5a14-6b19-4d3e-ad18-33e41e7ef87f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium 8-phenylamino-5-(4-(3-sulphonatophenylazo)-1-naphthylazo)naphthalenesulphonate,3351-05-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16003941-28e1-473e-8252-0dc6ca24a87c/documents/e967f84b-50db-4c12-9987-df04b3e2ec9a_92136fef-39ee-4829-8928-47a4e2ed97e8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Sodium 8-phenylamino-5-(4-(3-sulphonatophenylazo)-1-naphthylazo)naphthalenesulphonate,3351-05-1,The study was performed on a tested substance with a higher content of active ingredient. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16003941-28e1-473e-8252-0dc6ca24a87c/documents/IUC5-adeee771-ce43-423f-9c77-2bd8b0b95fe2_92136fef-39ee-4829-8928-47a4e2ed97e8.html,,,,,, Sodium 8-phenylamino-5-(4-(3-sulphonatophenylazo)-1-naphthylazo)naphthalenesulphonate,3351-05-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16003941-28e1-473e-8252-0dc6ca24a87c/documents/IUC5-adeee771-ce43-423f-9c77-2bd8b0b95fe2_92136fef-39ee-4829-8928-47a4e2ed97e8.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Sodium 9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",131-08-8,In a valid oral toxicity study a dose of 2000 mg/kg bw of Luprintan TX 4493 (= Anthraquinone-2-sulfonic acid sodium salt) was tolerated without symptoms. None of the animals died. The LD50 was greater than 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6a59f65-a09f-4205-ac2e-7e6ffff11f99/documents/cd6e97e7-4cd5-4cb3-9faa-aa781e3460cb_62b20ca0-f875-4e49-810e-6dfca95bc9e8.html,,,,,, "Sodium 9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",131-08-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6a59f65-a09f-4205-ac2e-7e6ffff11f99/documents/cd6e97e7-4cd5-4cb3-9faa-aa781e3460cb_62b20ca0-f875-4e49-810e-6dfca95bc9e8.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Sodium acrylate,7446-81-3," No experimental data on the test substance is available. Data on the structural analogue acrylic acid which has been extensively studied, is included for assessment.   Repeated dose toxicity - oral: NOAEL (rat, chronic) = 40 mg/kg bw/d (similar to OECD TG 452; study with the structural analogue acrylic acid CAS 79-10-7)   Repeated dose toxicity - inhalation: Systemic effects: NOAEC (mouse, subchronic) = 15 mg/m³ air Local effects: LOAEC (mouse, subchronic) = 15 mg/m³ air (similar to OECD TG 413; study with the structural analogue acrylic acid CAS 79-10-7)   Repeated dose toxicity - dermal: Systemic effects: no adverse effects observed Local effects: adverse effects observed, no NOAEL identified (similar to OECD TG 411; study with the structural analogue acrylic acid CAS 79-10-7) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/813c9720-1158-4b5c-992c-4e705e53c892/documents/66f98585-7a63-4bbc-9705-d61b27a77675_9d0fae29-865e-49cd-9da5-88ea44d808d9.html,,,,,, Sodium acrylate,7446-81-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/813c9720-1158-4b5c-992c-4e705e53c892/documents/66f98585-7a63-4bbc-9705-d61b27a77675_9d0fae29-865e-49cd-9da5-88ea44d808d9.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,15 mg/m3,,mouse Sodium acrylate,7446-81-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/813c9720-1158-4b5c-992c-4e705e53c892/documents/66f98585-7a63-4bbc-9705-d61b27a77675_9d0fae29-865e-49cd-9da5-88ea44d808d9.html,Chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat Sodium acrylate,7446-81-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/813c9720-1158-4b5c-992c-4e705e53c892/documents/66f98585-7a63-4bbc-9705-d61b27a77675_9d0fae29-865e-49cd-9da5-88ea44d808d9.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 mg/m3,adverse effect observed,mouse Sodium acrylate,7446-81-3,"The test substance was virtually nontoxic after a single ingestion in a study similar to OECD TG 401.Oral: LD50 > 5000 mg/kg bw (Wistar rat) No mortality was observed in an inhalation hazard test similar to OECD TG 403. Based on data from the structural analogue acrylic acid, the test substance is not toxic after short-term skin contact. Dermal: LD50 > 2000 mg/kg bw (rabbit) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/813c9720-1158-4b5c-992c-4e705e53c892/documents/139fc8d0-3688-4f37-9576-a3a96c65d9b2_9d0fae29-865e-49cd-9da5-88ea44d808d9.html,,,,,, Sodium acrylate,7446-81-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/813c9720-1158-4b5c-992c-4e705e53c892/documents/139fc8d0-3688-4f37-9576-a3a96c65d9b2_9d0fae29-865e-49cd-9da5-88ea44d808d9.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Sodium acrylate,7446-81-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/813c9720-1158-4b5c-992c-4e705e53c892/documents/139fc8d0-3688-4f37-9576-a3a96c65d9b2_9d0fae29-865e-49cd-9da5-88ea44d808d9.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Sodium antimonate,15432-85-6," Based on the fact that diantimony pentoxide, sodium hexahydroxoantimonate and sodium antimonate contain antimony in the pentavalent oxidation state and that water solubility testing as well as transformation dissolution testing has shown similar dissolution pattern of pentavalent antimony cations form all three substances, read-across among the pentavalent antimony compounds (i.e. sodium hexahydroxoantimonate, sodium antimonate and diantimony pentoxide) is considered justified.   No test item related changes were observed in a 90-day repeated dose toxicity study via oral route up to the limit dose of 1000 mg/kg bw/day with sodium hexahydroxoantimonate. The no-observed-effect level (NOEL) was above 1000 mg sodium hexahydroxoantimonate/kg b.w./day, p.o. for the male and female rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e05cbf4-d8c3-448d-a67f-bbe02780fd99/documents/6d833c9e-925b-4d67-b1c5-292bfe3b5666_aa3b7e3f-e8cc-4bbc-b000-da6696526e61.html,,,,,, Sodium antimonate,15432-85-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9e05cbf4-d8c3-448d-a67f-bbe02780fd99/documents/6d833c9e-925b-4d67-b1c5-292bfe3b5666_aa3b7e3f-e8cc-4bbc-b000-da6696526e61.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium antimonate,15432-85-6," Acute toxicity, oral: LD50 > 2000 mg/kg bw Acute toxicity, inhalation: LC50 > 5.40 mg sodium hexahydroxoantimonate/L air Based on the results of the histopathological and macroscopic investigations, sodium hexahydroxoantimonate (and by read-across antimony pentoxide and sodium antimonate) does not require classification for respiratory irritation. Acute toxicity, dermal: Conduct of an acute dermal toxicity study is unjustified as inhalation of the substance is considered as major route of exposure and physicochemical properties of the substance do not suggest a significant rate of absorption through the skin (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9e05cbf4-d8c3-448d-a67f-bbe02780fd99/documents/e42c71a8-cf9c-4285-aa03-aef8e04e8987_aa3b7e3f-e8cc-4bbc-b000-da6696526e61.html,,,,,, Sodium benzenesulphinate,873-55-2, LD50 was estimated to be 2752 mg/kg bw when Sprague-Dawley male and female rats were orally exposed with sodium benzenesulfinate. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9adfab5-3f3a-457f-9456-68ebc067a1e6/documents/bf83b45f-22d8-4337-a2c9-945780c8fd66_b3f08fce-8e07-4561-8189-ba9e586da431.html,,,,,, Sodium benzenesulphinate,873-55-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9adfab5-3f3a-457f-9456-68ebc067a1e6/documents/bf83b45f-22d8-4337-a2c9-945780c8fd66_b3f08fce-8e07-4561-8189-ba9e586da431.html,,oral,LD50,"2,752 mg/kg bw",no adverse effect observed, Sodium bis(trifluoromethylsulfonyl)imide,91742-21-1,Two reliable 28-day studies via the oral route are available for the structural analogue Lithium bis(trifluoromethylsulfonyl)imide. The liver and central nervous system were identified as the target organs. A dose level of 10 mg/kg may be considered as a NOAEL for systemic effects. The Lowest Observable Adverse Effect Level (LOAEL) was established at 45 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa78da1d-f2bd-4875-83bc-f26e7e3805b2/documents/e379932c-a51a-40d3-8e8a-65e3fd395d62_966d23c3-1301-454d-9e9c-18c41116dca7.html,,,,,, Sodium bis(trifluoromethylsulfonyl)imide,91742-21-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa78da1d-f2bd-4875-83bc-f26e7e3805b2/documents/e379932c-a51a-40d3-8e8a-65e3fd395d62_966d23c3-1301-454d-9e9c-18c41116dca7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Sodium bis(trifluoromethylsulfonyl)imide,91742-21-1,"The acute oral LD50 value of the test item sodium (bis)trifluoromethanesulfonimide was found to be between 50 and 300 mg/kg bw in female Crl:WI rats Base on the read-across with the source substance, LiTFSI, the LD50 by dermal route in rabbits was determined to be 371 mg/kg (males) and 418 mg/kg (females). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa78da1d-f2bd-4875-83bc-f26e7e3805b2/documents/fd29eed5-1980-4c4e-81d2-87a5a4a96955_966d23c3-1301-454d-9e9c-18c41116dca7.html,,,,,, Sodium bis(trifluoromethylsulfonyl)imide,91742-21-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa78da1d-f2bd-4875-83bc-f26e7e3805b2/documents/fd29eed5-1980-4c4e-81d2-87a5a4a96955_966d23c3-1301-454d-9e9c-18c41116dca7.html,,oral,LD50,>=50 mg/kg bw,adverse effect observed, Sodium bis(trifluoromethylsulfonyl)imide,91742-21-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa78da1d-f2bd-4875-83bc-f26e7e3805b2/documents/fd29eed5-1980-4c4e-81d2-87a5a4a96955_966d23c3-1301-454d-9e9c-18c41116dca7.html,,dermal,LD50,371 mg/kg bw,adverse effect observed, Sodium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-),64611-73-0," Oral: In an acute oral toxicity study similar to OECD 401 guideline, a LD50 of above 5000 mg/kg bw was determined (Stahl, 1980). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7cb972e-84e5-4040-9880-0b6e9c40d1dc/documents/9ce0812e-2256-4e66-9b9e-4cca2198c00c_9ace1112-f1c9-42d9-9575-62ebbb44ac21.html,,,,,, Sodium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-),64611-73-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7cb972e-84e5-4040-9880-0b6e9c40d1dc/documents/9ce0812e-2256-4e66-9b9e-4cca2198c00c_9ace1112-f1c9-42d9-9575-62ebbb44ac21.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Sodium bis[1-[(2-hydroxy-4-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-),64611-73-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c7cb972e-84e5-4040-9880-0b6e9c40d1dc/documents/9ce0812e-2256-4e66-9b9e-4cca2198c00c_9ace1112-f1c9-42d9-9575-62ebbb44ac21.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Sodium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-),57206-81-2," Oral: In an acute oral toxicity study similar to OECD 401 guideline, a LD50 of above 5000 mg/kg bw was determined (Stahl, 1980). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/142c4e6b-51e3-4554-9943-0a31f332056d/documents/bbb480d8-e662-42b8-a400-b91fbe9e746b_8a186bc8-ad80-4073-9f1e-0fd2c4280b7d.html,,,,,, Sodium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-),57206-81-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/142c4e6b-51e3-4554-9943-0a31f332056d/documents/bbb480d8-e662-42b8-a400-b91fbe9e746b_8a186bc8-ad80-4073-9f1e-0fd2c4280b7d.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Sodium bis[1-[(2-hydroxy-5-nitrophenyl)azo]-2-naphtholato(2-)]chromate(1-),57206-81-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/142c4e6b-51e3-4554-9943-0a31f332056d/documents/bbb480d8-e662-42b8-a400-b91fbe9e746b_8a186bc8-ad80-4073-9f1e-0fd2c4280b7d.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Sodium bis[2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-)",64560-69-6,LD50(oral) > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7dbe0d88-f3f4-4803-a6fc-45e614d86203/documents/ade7948f-8cb3-4bd8-aaea-2ca3edab7bb8_3bae7166-b39a-4e09-9134-f66eb42da823.html,,,,,, "Sodium bis[2,4-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-)",67352-37-8,LD50(oral) > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/44b0f013-36a3-40b6-a450-04c71b349313/documents/IUC5-e48a955c-f2f4-49de-8198-8c1c95a282f0_b555f9df-3743-434d-b0e4-1d9dd1c8f246.html,,,,,, "Sodium bis[2,4-dihydro-4-[[2-hydroxy-5-(methylsulphonyl)-4-nitrophenyl]azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-)",71839-91-3," In three acute oral toxicity studies LD50 values of above 4000 mg/kg bw were determined (BASF 1969, 1970, 1972). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95c5f120-758d-499b-a592-a456fe7b799b/documents/IUC5-0fa4520f-954f-49bd-bcb8-13ca73924ada_4ebd84ef-2c51-4610-af92-8cea1e3a25f7.html,,,,,, "Sodium bis[2,4-dihydro-4-[[2-hydroxy-5-(methylsulphonyl)-4-nitrophenyl]azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)]chromate(1-)",71839-91-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/95c5f120-758d-499b-a592-a456fe7b799b/documents/IUC5-0fa4520f-954f-49bd-bcb8-13ca73924ada_4ebd84ef-2c51-4610-af92-8cea1e3a25f7.html,,oral,discriminating dose,"4,000 mg/kg bw",no adverse effect observed, "Sodium bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",41741-86-0," In a Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Test, the oral administration by gavage of the test item to Wistar rats revealed no signs of systemic toxicity up to a dose level of 1000 mg/kg bw/d in animals of both sexes. Thus, the no observed adverse effect level (NOAEL) for general systemic toxicit was 1000 mg/kg bw/d for male and female Wistar rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6757f9e1-6d9a-40b0-a6c9-de7c140c94d2/documents/ce8e915b-45c0-44ab-ad24-30452f47aa4b_9d4142e2-b920-47ff-ac80-a04568538511.html,,,,,, "Sodium bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",41741-86-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6757f9e1-6d9a-40b0-a6c9-de7c140c94d2/documents/ce8e915b-45c0-44ab-ad24-30452f47aa4b_9d4142e2-b920-47ff-ac80-a04568538511.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Sodium bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",41741-86-0, The substance was not acutely toxic by the oral rout and after intraperitoneal application. In an inhalation risk test none of the test animals died when exposed to an atmosphere enriched with the test article for 7 hours. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6757f9e1-6d9a-40b0-a6c9-de7c140c94d2/documents/a33c373f-65bc-4044-ae08-553ba00a936a_9d4142e2-b920-47ff-ac80-a04568538511.html,,,,,, "Sodium bis[2-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]benzoato(2-)]chromate(1-)",41741-86-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6757f9e1-6d9a-40b0-a6c9-de7c140c94d2/documents/a33c373f-65bc-4044-ae08-553ba00a936a_9d4142e2-b920-47ff-ac80-a04568538511.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Sodium bis[2-[[5-(aminosulphonyl)-2-hydroxyphenyl]azo]-3-oxo-N-phenylbutyramidato(2-)]cobaltate(1-),72496-88-9,Acute Oral LD50 > 10000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46f6a2c9-1607-46aa-8b27-d3a328484702/documents/IUC5-23d260e4-f03d-4b16-8c75-55d73230d663_3103dba3-ed4e-4784-99fb-a59c2e606fa6.html,,,,,, Sodium bis[2-[[5-(aminosulphonyl)-2-hydroxyphenyl]azo]-3-oxo-N-phenylbutyramidato(2-)]cobaltate(1-),72496-88-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/46f6a2c9-1607-46aa-8b27-d3a328484702/documents/IUC5-23d260e4-f03d-4b16-8c75-55d73230d663_3103dba3-ed4e-4784-99fb-a59c2e606fa6.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Sodium bis[2-chloro-4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-hydroxybenzenesulphonamidato(2-)]chromate(1-)",67109-27-7,"The acute oral median lethal dose (LD50) of Acid Red 211 in rats of both sex is greater than 5,000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b986742-5daf-4c2c-94a6-27687fb88f15/documents/IUC5-0b1d9339-f2a6-4dda-bc98-9015a63569a2_ba225663-e590-4711-b60d-567a096f1796.html,,,,,, "Sodium bis[2-chloro-4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-5-hydroxybenzenesulphonamidato(2-)]chromate(1-)",67109-27-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b986742-5daf-4c2c-94a6-27687fb88f15/documents/IUC5-0b1d9339-f2a6-4dda-bc98-9015a63569a2_ba225663-e590-4711-b60d-567a096f1796.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Sodium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzene-1-sulphonamidato(2-)]chromate(1-)",72275-69-5,LD50 > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9587eb6f-076d-42a5-9806-b6067b0f35eb/documents/IUC5-94141cd9-af89-43db-acbb-b5b25fbe2e32_55326408-6b04-4e33-9523-39c1ba2ecd97.html,,,,,, "Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxybenzenesulphonamidato(2-)]cobaltate(1-)",73612-40-5," Acute oral toxicity, LD50: > 2000 mg/kg bw Acute inhalation toxicity: waiving Acute dermal toxicity: LD50 male/female: > 2000 mg/Kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b8331d3-479b-4d7d-a4ae-ecc454f32aee/documents/8ff222e5-ef95-45c4-94fd-a68ec832c9da_2081dcb2-7672-4e69-92a3-7b65c42a7901.html,,,,,, "Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxybenzenesulphonamidato(2-)]cobaltate(1-)",73612-40-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b8331d3-479b-4d7d-a4ae-ecc454f32aee/documents/8ff222e5-ef95-45c4-94fd-a68ec832c9da_2081dcb2-7672-4e69-92a3-7b65c42a7901.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzene-1-sulphonamidato(2-)]chromate(1-)",71839-81-1, Acute oral toxicity was determined in male albino rats. The LD50 was above 5000 mg/kg body weight. No adverse findings were reported. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6428f85b-0318-43fb-9503-8d243bf9a8f8/documents/6a67fa72-1757-47b1-bd07-61dd60db0ab1_fcc15f8f-9d05-4948-8abc-7350660114b0.html,,,,,, "Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzene-1-sulphonamidato(2-)]chromate(1-)",71839-81-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6428f85b-0318-43fb-9503-8d243bf9a8f8/documents/6a67fa72-1757-47b1-bd07-61dd60db0ab1_fcc15f8f-9d05-4948-8abc-7350660114b0.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)]cobaltate(1-)",71701-14-9, No deaths were observed in an oral study according to OECD TG 423 at a dose level of 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a53aaa5c-6487-468a-9e99-1b6fe9c83435/documents/0ba4b045-620b-43eb-9067-d803f4dcee53_0e671a85-4167-4f4d-8f14-5f06448d6e59.html,,,,,, "Sodium bis[3-[[1-(3-chlorophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]-4-hydroxy-N-methylbenzenesulphonamidato(2-)]cobaltate(1-)",71701-14-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a53aaa5c-6487-468a-9e99-1b6fe9c83435/documents/0ba4b045-620b-43eb-9067-d803f4dcee53_0e671a85-4167-4f4d-8f14-5f06448d6e59.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium bis[4-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]benzenesulphonamidato(2-)]cobaltate(1-),58302-43-5,LD50(oral) > 2000 mg/kg (OECD 423 guideline) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d54164e6-77e9-431f-b35d-f37a4fd91b97/documents/IUC5-2216680c-dc33-4e93-b1ed-23c7b8612593_bba84d0e-b617-49b7-97bb-c4299cfb7dd5.html,,,,,, Sodium bis[4-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-N-(3-methoxypropyl)benzenesulphonamidato(2-)]cobaltate(1-),71735-61-0, The LD50 was > 2500 mg/kg after single oral administration to rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2dc56d50-95d1-475b-aa1c-b72e195ae104/documents/0ff3e931-71e0-4009-bd63-a65a79525720_48bb78c7-b2a2-4e35-be45-f43bdeb1d077.html,,,,,, Sodium bis[4-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-N-(3-methoxypropyl)benzenesulphonamidato(2-)]cobaltate(1-),71735-61-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2dc56d50-95d1-475b-aa1c-b72e195ae104/documents/0ff3e931-71e0-4009-bd63-a65a79525720_48bb78c7-b2a2-4e35-be45-f43bdeb1d077.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-),70247-74-4,LD50 (oral) in rats is greater than 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d4d3efa-6311-4d62-bbfb-ea26217db9df/documents/IUC5-9f729d2c-e84f-4dc3-8d94-38127b4330c4_0ad05ddc-a7de-408f-9e14-25decae1f094.html,,,,,, Sodium bis[N-(2-chlorophenyl)-2-[[2-hydroxy-5-(N-methylsulphamoyl)phenyl]azo]-3-oxobutyramidato(2-)]cobaltate(1-),70247-74-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8d4d3efa-6311-4d62-bbfb-ea26217db9df/documents/IUC5-9f729d2c-e84f-4dc3-8d94-38127b4330c4_0ad05ddc-a7de-408f-9e14-25decae1f094.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium bis[N-[7-hydroxy-8-[[2-hydroxy-5-[(methylamino)sulphonyl]phenyl]azo]-1-naphthyl]acetamidato(2-)]chromate(1-),68966-87-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/646656cb-acd7-463d-b8c1-acafc0035dcf/documents/IUC5-7277d1c6-4991-47a9-a967-b006507c4f8b_e5e2bc03-165b-4379-9622-b978234f4404.html,,inhalation,LC50,"4,820 mg/m3",no adverse effect observed, Sodium bromide,7647-15-6,NOAEL=60mg/kg/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9502200b-23f9-47bc-957c-91a335f1f9dd/documents/IUC5-5627285f-a902-4468-a658-e5d99a6501dc_e3bc62ee-a2a7-4495-9f47-6bbb42da741a.html,,,,,, Sodium bromide,7647-15-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9502200b-23f9-47bc-957c-91a335f1f9dd/documents/IUC5-5627285f-a902-4468-a658-e5d99a6501dc_e3bc62ee-a2a7-4495-9f47-6bbb42da741a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,60 mg/kg bw/day,,rat Sodium bromide,7647-15-6,Oral: The LD50 was determined to be > 2000 mg/kg bwDermal: The acute dermal LD50 was determined to be > 2000 mg/kg bw. Inhalation: The substance is not volatile and is not inhalable. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9502200b-23f9-47bc-957c-91a335f1f9dd/documents/IUC5-42d7c111-626c-4702-96de-5bc38fa0b7b6_e3bc62ee-a2a7-4495-9f47-6bbb42da741a.html,,,,,, Sodium chloroacetate,3926-62-3," Toxicity (except dermal toxicity and skin/eye irritation) of SMCA (the sodium salt of MCAA) is identical to that of MCAA. Under physiological conditions both substances are completely ionised and the relevant moiety is the monochloroacetate ion. Many studies have used monochloroacetic acid neutralized with sodium hydroxide or its sodium salt, so that data of monochloroacetate can be used to also evaluate the systemic toxicity for sodium monochloroacetic acid (and vice versa). In a dermal toxicity study (see section 7.2.3) with rabbit skin it was shown, in addition, that the toxicity of MCA is not caused by a surplus of H+ ions and that the influence of pH appeared to be secondary, because its direct reaction to biomolecules was the primary cause of cytotoxicity. Key study: 13-week study in rats according to OECD 408. Outcome NOAEL 30 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b41fffc1-7656-4845-bcd5-bbb1397ea877/documents/cce6f712-067b-4cc4-ae10-92518e281a23_3d547356-d1f4-406d-95b9-63f71b2dfff2.html,,,,,, Sodium chloroacetate,3926-62-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b41fffc1-7656-4845-bcd5-bbb1397ea877/documents/cce6f712-067b-4cc4-ae10-92518e281a23_3d547356-d1f4-406d-95b9-63f71b2dfff2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat Sodium chloroacetate,3926-62-3," The information is based on monochloroacetic acid (MCA) which is a strong acid and dissociates in biological media; many studies have used monochloroacetic acid neutralized with sodium hydroxide or its sodium salt, so that data of monochloroacetate can be used to also evaluate the systemic toxicity for sodium monochloroacetic acid (and vice versa). In a dermal toxicity study (see section 7.2.3) with rabbit skin it was shown, in addition, that the toxicity of MCA is not caused by a surplus of H+ ions and that the influence of pH appeared to be secondary, because its direct reaction to biomolecules was the primary cause of cytotoxicity. Acute oral toxicity (based on MCA): Rat LD50  90 mg/kg bw,  standard acute toxicity method Acute dermal toxicity (based on SMCA): Rat LD 50 3250 mg/kg bw (males); > 2000 mg/kg bw (females). Non-guideline, non GLP but similar to standard acute dermal toxicity test Acute inhalation toxicity (based on MCA): Rat 4 -h LC50 >> 1286 mg/m3 in air. OECD 403, GLP. With regard to dermal toxicity it was shown that SMCA is ca. 10 times less toxic than MCA. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b41fffc1-7656-4845-bcd5-bbb1397ea877/documents/a561b229-fb8b-477f-8bf0-e07168f230e9_3d547356-d1f4-406d-95b9-63f71b2dfff2.html,,,,,, Sodium chloroacetate,3926-62-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b41fffc1-7656-4845-bcd5-bbb1397ea877/documents/a561b229-fb8b-477f-8bf0-e07168f230e9_3d547356-d1f4-406d-95b9-63f71b2dfff2.html,,oral,LD50,90 mg/kg bw,adverse effect observed, Sodium chloroacetate,3926-62-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b41fffc1-7656-4845-bcd5-bbb1397ea877/documents/a561b229-fb8b-477f-8bf0-e07168f230e9_3d547356-d1f4-406d-95b9-63f71b2dfff2.html,,dermal,LD50,"3,250 mg/kg bw",adverse effect observed, Sodium chloroacetate,3926-62-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b41fffc1-7656-4845-bcd5-bbb1397ea877/documents/a561b229-fb8b-477f-8bf0-e07168f230e9_3d547356-d1f4-406d-95b9-63f71b2dfff2.html,,inhalation,discriminating conc.,"1,286 mg/m3",no adverse effect observed, Sodium chlorodifluoroacetate,1895-39-2,"Acute oral toxicity: Key study. Test method according to OECD 423, GLP study. The LD50 of the test item is 5000 mg/kg g body weight by oral route in the rat. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Key study with Klimisch score = 1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d03e89d1-3759-4965-a9bb-726239f3aba6/documents/6ff2949d-f418-4b32-8672-7d68a3c3a08c_11a1f4ac-0da0-4d7d-b1a8-6de674c0df44.html,,,,,, Sodium chlorodifluoroacetate,1895-39-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d03e89d1-3759-4965-a9bb-726239f3aba6/documents/6ff2949d-f418-4b32-8672-7d68a3c3a08c_11a1f4ac-0da0-4d7d-b1a8-6de674c0df44.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Sodium dibenzyldithiocarbamate,55310-46-8,"No data are available on acute toxicity of isolated (anhydrous) sodium dibenzyldithiocarbamate. However, as the substance is manufactured and marketed by the registrant solely as a saturated (ca. 17%) aqueous solution, an exposure to pure substance is not expected to be possible. Therefore for the risk assessment purposes it is considered to be acceptable and in fact more relevant to use acute toxicity data on the substance as manufactured. Acute oral toxicity of 16.9% aqueous solution of sodium dibenzyldithiocarbamate is low (LD50 > 2000 mg/kg bw ), based on the study with rats performed in accordance with OECD 401 and GLP. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3815964-2674-4657-80bd-e35f5ec19b57/documents/IUC5-2241b776-edf5-4581-8c4e-ff23501207e2_0f58206f-31c1-4f36-99b8-e204cfcd6e22.html,,,,,, Sodium dibutyldithiocarbamate,136-30-1,"No data on repeated dose toxicity of SDBC are available. However, a reliable 90-day study is available for a structural analogue of SDBC, sodium dimethyldithiocarbamate (SDMC), in which a NOAEL of 10 mg/kg bw/day (calculated for pure (anhydrous) substance) was established, based on haemolytic effects manifested as an increase in mean corpuscular haemoglobin and mean corpuscular volume in both sexes, decreased hepatopoisis in spleen and signs of bone marrow hyperplasia in females. Applying a correction factor for the difference in molecular weight for SDBC (227/143), this leads to a NOAEL of 16 mg/kg bw/day for isolated (anhydrous) SDBC. This corresponds to a NOAEL of 34 mg/kg bw/day for its aqueous solution (47%). The value for the pure substance shall be used for DNEL derivation. NOAEL pure substance = 16 mg/kg bw/d NOAEL 47% aq.solution = 34 mg/kg bw/d LOAEL pure substance = 79 mg/kg bw/d LOAEL 47% aq.solution = 169 mg/kg bw/d Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): OECD TG 408 study performed under GLP ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/abff92e1-f040-4bbf-8ed8-5552591abc88/documents/IUC5-63148da6-c78d-4f4d-8e4c-8f637964dd68_425359a7-0096-46dc-9ceb-158859c7c03f.html,,,,,, Sodium dibutyldithiocarbamate,136-30-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/abff92e1-f040-4bbf-8ed8-5552591abc88/documents/IUC5-63148da6-c78d-4f4d-8e4c-8f637964dd68_425359a7-0096-46dc-9ceb-158859c7c03f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,16 mg/kg bw/day,,rat Sodium dibutyldithiocarbamate,136-30-1,"No data on acute toxicity of isolated (anhydrous) sodium dibutyldithiocarbamate are available. However, the substance is solely manufactured and marketed by the registrant as a saturated aqueous solution (ca. % 45.5%-47.5% w/w) and it is not expected that exposure to pure substance is possible. Therefore for the risk assessment it is considered to be acceptable and in fact more relevant to use acute toxicity data on the substance as manufactured. The acute oral toxicity studies with sodium dibutyldithiocarbamate as a 46.20% solution in water (SDBC is manufactured as a 45.5-47.5% solution) showed LD50 values between 300 and 2000 mg/kg bw. Calculated for the isolated (anhydrous) substance, this corresponds to LD50 of 141-940 mg/kg bw. In the earlier acute oral toxicity study with rats using 47.5% aqueous solution of SDBC, LD50 of 1430 and 1330 mg/kg bw was established for males and females, respectively; recalculated for the isolated (anhydrous) substance, this corresponds to LD50 of 672 and 625 mg/kg bw for males and females, respectively. In the acute dermal toxicity study in which 3 female rats were treated with 1000 mg/kg bw sodium dibutyldithiocarbamate as 46.20% solution in water one animals died and two animals were killed at day 8 in extremis, showing that the LD50 value is around or slightly below 1000 mg/kg bw. No data on acute inhalation toxicity are available; however, in accordance with REACH Annex VIII, the study does not need to be conducted as data on two other routes of exposure are available. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): OECD TG 423 study performed under GLP Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): OECD TG 402 study performed under GLP ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abff92e1-f040-4bbf-8ed8-5552591abc88/documents/IUC5-49417ffc-48a4-4634-95fa-d9b7ca3ed808_425359a7-0096-46dc-9ceb-158859c7c03f.html,,,,,, Sodium dibutyldithiocarbamate,136-30-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abff92e1-f040-4bbf-8ed8-5552591abc88/documents/IUC5-49417ffc-48a4-4634-95fa-d9b7ca3ed808_425359a7-0096-46dc-9ceb-158859c7c03f.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Sodium dibutyldithiocarbamate,136-30-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/abff92e1-f040-4bbf-8ed8-5552591abc88/documents/IUC5-49417ffc-48a4-4634-95fa-d9b7ca3ed808_425359a7-0096-46dc-9ceb-158859c7c03f.html,,dermal,LD50,"< 1,000 mg/kg bw",adverse effect observed, Sodium dicyanoamide,1934-75-4," In an acute oral toxicity study using albino rats, the oral LD50 was 725 mg/kg bw (95% CL: 605 -875 mg/kg bw) in males and 775.0 mg/kg bw in females (95% CL: 670.0 - 895.0 mg/kg bw). The study has been conducted before implementation of GLP. Additionally, handbook data indicate that the oral LD50 in mice was about 1000 mg/kg and the intraperitoneal LD50 610 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f6f79db-5937-4c8d-99e8-62704ddbd1d5/documents/ff432184-0f82-4b8f-8b39-886c79453a05_57a13123-530c-4443-907f-d34ca4b029cc.html,,,,,, Sodium dicyanoamide,1934-75-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2f6f79db-5937-4c8d-99e8-62704ddbd1d5/documents/ff432184-0f82-4b8f-8b39-886c79453a05_57a13123-530c-4443-907f-d34ca4b029cc.html,,oral,LD50,725 mg/kg bw,adverse effect observed, Sodium diethyldithiocarbamate,148-18-5,"Sub-chronic toxicity studies with rats and mice were avalable for assessment with sodium diethyldithiocarbamate trihydrate, which were performed as a part of carcinogenicity study. In the study with rats, NOAEL was 425 mg/kg bw/day, based on a very slight increase in splenic hematopoiesis and a very small amount of vacuolation of renal tubular epithelium. Recalculated for anhydrous substance, this corresponds to 332 mg/kg bw/day, respectively. In the study with mice, no effects were observed at the highest tested dose, resulting in NOAEL of 1305 mg/kg bw/day. Recalculated for anhydrous substance, this corresponds to 1019 mg/kg bw/day, respectively. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): NTP studies ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa40cc79-5cac-4a93-b5ed-25103d5f4220/documents/IUC5-0492b04f-f014-4bc7-83b8-81c4e063dc39_a0c9773a-c546-4430-868a-0ef669acc8c1.html,,,,,, Sodium diethyldithiocarbamate,148-18-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fa40cc79-5cac-4a93-b5ed-25103d5f4220/documents/IUC5-0492b04f-f014-4bc7-83b8-81c4e063dc39_a0c9773a-c546-4430-868a-0ef669acc8c1.html,Chronic toxicity – systemic effects,oral,NOAEL,425 mg/kg bw/day,,rat Sodium diethyldithiocarbamate,148-18-5,19.4% sodium diethyldithiocarbamate (SDEC)LD50 > 5000 mg/kg bw Calculation based on the above: 26% aqueous solution SDEC LD50 > 3654 mg/kg bw Anhydrous SDEC LD50 > 970 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa40cc79-5cac-4a93-b5ed-25103d5f4220/documents/IUC5-744c77d4-f1af-4ee1-96c1-798077671772_a0c9773a-c546-4430-868a-0ef669acc8c1.html,,,,,, Sodium diethyldithiocarbamate,148-18-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa40cc79-5cac-4a93-b5ed-25103d5f4220/documents/IUC5-744c77d4-f1af-4ee1-96c1-798077671772_a0c9773a-c546-4430-868a-0ef669acc8c1.html,,oral,LD50,> 970 mg/kg bw,adverse effect observed, Sodium diethyldithiocarbamate,148-18-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fa40cc79-5cac-4a93-b5ed-25103d5f4220/documents/IUC5-744c77d4-f1af-4ee1-96c1-798077671772_a0c9773a-c546-4430-868a-0ef669acc8c1.html,,dermal,LD50,"> 3,654 ",, Sodium diisobutyldithiophosphinate,13360-78-6,"In an OECD 422 study, toxicity was noted at 300 mg/kg, and was characterized by mortality (five animals in total) and various clinical signs.In an OECD 408 study, slight non adverse toxicity was noted at 150 mg/kg. This was considered as the NOAEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8dbb6145-c417-4ebd-a1a9-e5cb01bc6747/documents/IUC5-31766b80-dc95-4108-ba2c-1ff862ad9552_02641a55-452d-49ca-9a49-a8b89cf7e560.html,,,,,, Sodium diisobutyldithiophosphinate,13360-78-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8dbb6145-c417-4ebd-a1a9-e5cb01bc6747/documents/IUC5-31766b80-dc95-4108-ba2c-1ff862ad9552_02641a55-452d-49ca-9a49-a8b89cf7e560.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat Sodium diisobutyldithiophosphinate,13360-78-6,"The test material exhibits low acute toxicity as evidenced by no observations of mortality at the dose of 2000 mg/kg via both the oral and dermal exposure routes. For the inhalation route, no reliable data are available. Since oral and dermal data are available, inhalation data are not required under REACH. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dbb6145-c417-4ebd-a1a9-e5cb01bc6747/documents/IUC5-e1f606d5-c614-4850-b37e-0652e3bcab63_02641a55-452d-49ca-9a49-a8b89cf7e560.html,,,,,, Sodium diisobutyldithiophosphinate,13360-78-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dbb6145-c417-4ebd-a1a9-e5cb01bc6747/documents/IUC5-e1f606d5-c614-4850-b37e-0652e3bcab63_02641a55-452d-49ca-9a49-a8b89cf7e560.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium diisobutyldithiophosphinate,13360-78-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8dbb6145-c417-4ebd-a1a9-e5cb01bc6747/documents/IUC5-e1f606d5-c614-4850-b37e-0652e3bcab63_02641a55-452d-49ca-9a49-a8b89cf7e560.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium dimethyl 5-sulphonatoisophthalate,3965-55-7,Sodium Sulfo Dimehtylisophtalate has a NOAEL of 1000 mg/kg bw/d for repeated dose toxicity (oral). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36086a75-7f74-48d5-b08c-85632d3b7737/documents/IUC5-c541def9-a706-4250-91b8-a3e63c20579e_20461611-363e-4890-9fc7-52f8c8c7c625.html,,,,,, Sodium dimethyl 5-sulphonatoisophthalate,3965-55-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36086a75-7f74-48d5-b08c-85632d3b7737/documents/IUC5-c541def9-a706-4250-91b8-a3e63c20579e_20461611-363e-4890-9fc7-52f8c8c7c625.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium dimethyl 5-sulphonatoisophthalate,3965-55-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36086a75-7f74-48d5-b08c-85632d3b7737/documents/IUC5-c541def9-a706-4250-91b8-a3e63c20579e_20461611-363e-4890-9fc7-52f8c8c7c625.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"32,000 mg/m3",,rat Sodium dimethyl 5-sulphonatoisophthalate,3965-55-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/36086a75-7f74-48d5-b08c-85632d3b7737/documents/IUC5-c541def9-a706-4250-91b8-a3e63c20579e_20461611-363e-4890-9fc7-52f8c8c7c625.html,Repeated dose toxicity – local effects,inhalation,LOAEC,"32,000 mg/m3",adverse effect observed,rat Sodium dimethyl 5-sulphonatoisophthalate,3965-55-7,"LD50 (acute oral, rat) > 2000 mg/kg bw LC50 (inhalation, rat) > 32 mg/L LD50 (acute dermal, rat) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36086a75-7f74-48d5-b08c-85632d3b7737/documents/IUC5-82a551bf-7509-473f-8a5f-d5934d6bedfb_20461611-363e-4890-9fc7-52f8c8c7c625.html,,,,,, Sodium dimethyl 5-sulphonatoisophthalate,3965-55-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36086a75-7f74-48d5-b08c-85632d3b7737/documents/IUC5-82a551bf-7509-473f-8a5f-d5934d6bedfb_20461611-363e-4890-9fc7-52f8c8c7c625.html,,oral,discriminating dose,"11,000 mg/kg bw",no adverse effect observed, Sodium dimethyl 5-sulphonatoisophthalate,3965-55-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36086a75-7f74-48d5-b08c-85632d3b7737/documents/IUC5-82a551bf-7509-473f-8a5f-d5934d6bedfb_20461611-363e-4890-9fc7-52f8c8c7c625.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Sodium dimethyl 5-sulphonatoisophthalate,3965-55-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/36086a75-7f74-48d5-b08c-85632d3b7737/documents/IUC5-82a551bf-7509-473f-8a5f-d5934d6bedfb_20461611-363e-4890-9fc7-52f8c8c7c625.html,,inhalation,discriminating conc.,"32,000 mg/m3",no adverse effect observed, Sodium dimethyldithiocarbamate,128-04-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study, and is thus sufficient to fulfill the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6fd577bc-1a5c-4f2c-a985-dba7456f8e9e/documents/246043a0-bddb-4ee3-9286-b1fd10e05cdf_bb815ef6-472f-45c4-8e39-11e77ab818bd.html,,,,,, Sodium dimethyldithiocarbamate,128-04-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6fd577bc-1a5c-4f2c-a985-dba7456f8e9e/documents/246043a0-bddb-4ee3-9286-b1fd10e05cdf_bb815ef6-472f-45c4-8e39-11e77ab818bd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Sodium dimethyldithiocarbamate,128-04-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study, and is thus sufficient to fulfill the standard information requirements set out in Annex VII, 8.5, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study, and is thus sufficient to fulfill the standard information requirements set out in Annex VIII, 8.5, of Regulation (EC) No 1907/2006. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fd577bc-1a5c-4f2c-a985-dba7456f8e9e/documents/66ced1f9-f228-4f5b-a3f9-1c2daef52aa5_bb815ef6-472f-45c4-8e39-11e77ab818bd.html,,,,,, Sodium dimethyldithiocarbamate,128-04-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fd577bc-1a5c-4f2c-a985-dba7456f8e9e/documents/66ced1f9-f228-4f5b-a3f9-1c2daef52aa5_bb815ef6-472f-45c4-8e39-11e77ab818bd.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Sodium dimethyldithiocarbamate,128-04-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fd577bc-1a5c-4f2c-a985-dba7456f8e9e/documents/66ced1f9-f228-4f5b-a3f9-1c2daef52aa5_bb815ef6-472f-45c4-8e39-11e77ab818bd.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Sodium ethanolate,141-52-6,"Oral: Read-Across; NOAEL(male rat, female mouse) > 5%, NOAEL(female rat, male mouse) < 5% (3250 mg/kg bw/day); rat & mouse; 90d; according to internal NTP-standard; GLP; K2 Inhalation: no study available Dermal: no study available ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29cab360-9db6-4bba-819a-8b6a217d83f1/documents/IUC5-e751c69a-9154-4704-8b17-7957da173d44_cf2e9f34-e6f9-41ce-9ef0-2565bf73e019.html,,,,,, Sodium ethanolate,141-52-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29cab360-9db6-4bba-819a-8b6a217d83f1/documents/IUC5-e751c69a-9154-4704-8b17-7957da173d44_cf2e9f34-e6f9-41ce-9ef0-2565bf73e019.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,250 mg/kg bw/day",,rat Sodium ethanolate,141-52-6,Oral: LD50 = 560 mg/kg bw; rat; according to OECD TG 401; non-GLP; K1 Inhalation: no information available Dermal: no information available   ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29cab360-9db6-4bba-819a-8b6a217d83f1/documents/IUC5-d42071b6-ed20-4b25-93e9-048ff7ad51c2_cf2e9f34-e6f9-41ce-9ef0-2565bf73e019.html,,,,,, Sodium ethanolate,141-52-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29cab360-9db6-4bba-819a-8b6a217d83f1/documents/IUC5-d42071b6-ed20-4b25-93e9-048ff7ad51c2_cf2e9f34-e6f9-41ce-9ef0-2565bf73e019.html,,oral,LD50,560 mg/kg bw,adverse effect observed, Sodium ethylenesulphonate,3039-83-6,"In a reliable combined repeated dose and reproductive/developmental toxicity screening test (OECD TG 422) with a similar multi-constituent substance solution containing 25.4% sodium ethylene sulphonate by oral gavage in rats no systemic toxicity occurred up to the high dose level of 2000 mg/kg bw/day. The NOAEL was determined to be greater than 2000 mg/kg bw/day for the test solution. Based on this study the derived repeated dose NOAEL for 100% sodium ethylene sulphonate was greater than 500 mg active ingredient/kg bw/day. As this study was not dosed up to 1000 mg/kg bw/d active substance (sodium vinyl sulphonate SVS), ECHA requested a new OECD 422 study to be performed, dosed up to 1000 mg/kg bw/d active substance. This study was performed and is reported here, too. Likewise, in this new study, dosed up to 1000 mg active ingredient/kg bw/d no effects were noted for repeated dose toxicity or reproductive parameters and thus, the NOAEL for repeat dose toxicity, fertility and developmental toxicity in this study was set to the highest dose tested, i.e. 1000 mg/kg bw/d. A sub-chronic oral toxicity study according to OECD 408 has been performed for sodium ethenylsulphonate in rats. Also, in this study no negative effects were observed and the NOAEL in this study was established at the highest dose tested, 1000 mg active ingredient/kg bw/d. Repeated dose toxicity studies for the inhalation or dermal route are not required. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): two valid OECD TG 422 studies, one dosed up to 500 mg SVS/kg bw/d and one up to 1000 mg SVC/kg bw/d do support the main study (OECD 408, subchronic oral toxicity), also resulting in a NOAEL of 1000 mg SVS/kg bw/d. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d36c35c-741f-4ff5-beed-aa288b46b11c/documents/123fee36-608d-4952-bcb4-3a104f1ea519_eaf9a807-0c37-4610-b94d-c24daa627e57.html,,,,,, Sodium ethylenesulphonate,3039-83-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d36c35c-741f-4ff5-beed-aa288b46b11c/documents/123fee36-608d-4952-bcb4-3a104f1ea519_eaf9a807-0c37-4610-b94d-c24daa627e57.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium ethylenesulphonate,3039-83-6,Oral: LD50 > 3750 mg/kg bw for the rat Inhalation: no study requiredDermal: LD50 > 500 mg/kg bw for the rat ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d36c35c-741f-4ff5-beed-aa288b46b11c/documents/5ca1da7f-4b60-4208-aabc-2f9db499121c_eaf9a807-0c37-4610-b94d-c24daa627e57.html,,,,,, Sodium ethylenesulphonate,3039-83-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d36c35c-741f-4ff5-beed-aa288b46b11c/documents/5ca1da7f-4b60-4208-aabc-2f9db499121c_eaf9a807-0c37-4610-b94d-c24daa627e57.html,,oral,discriminating dose,"3,750 mg/kg bw",no adverse effect observed, Sodium ethylenesulphonate,3039-83-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d36c35c-741f-4ff5-beed-aa288b46b11c/documents/5ca1da7f-4b60-4208-aabc-2f9db499121c_eaf9a807-0c37-4610-b94d-c24daa627e57.html,,dermal,discriminating dose,500 mg/kg bw,no adverse effect observed, Sodium feredetate,15708-41-5,"NOAEL is >= 84 mg/kg bw/day for rats after 31/61 days of exposure via the food. A repeated 12-day inhalation toxicity with another chelate (Ca-DTPA) at levels up to 1.18 mg/L induced only a mild, focal and reversible pulmonary histiocytosis in the rat. Several studies are available for various chelates. The 2-year NOAEL in a rat study with EDTA-CaNa2 was >= 250 mg/kg bw. Other long term oral toxicity studies with other metal chelates or with EDTA showed comparable results. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11da98c4-457f-4a3b-af04-c6f12ffbda7f/documents/IUC5-cc3934cd-6da0-44df-9026-3f2f934e4608_093c24f9-5d8d-4781-8554-8c31fc64d376.html,,,,,, Sodium feredetate,15708-41-5,"LD50 (oral, rat) exceeded 2000 mg/kg bw LD50 (dermal, rat) exceeded 2000 mg/kg bw LC50 (rat, 4h) exceeded 2.75 +/- 0.19 mg/L, the technicaly maximally attainable concentration.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11da98c4-457f-4a3b-af04-c6f12ffbda7f/documents/IUC5-abaf17c2-4cbf-421a-846b-7e64499ee80b_093c24f9-5d8d-4781-8554-8c31fc64d376.html,,,,,, Sodium hexahydroxoantimonate,33908-66-6," Based on the fact that diantimony pentoxide, sodium hexahydroxoantimonate and sodium antimonate contain antimony in the pentavalent oxidation state and that water solubility testing as well as transformation dissolution testing has shown similar dissolution pattern of pentavalent antimony cations form all three substances, read-across among the pentavalent antimony compounds (i.e. sodium hexahydroxoantimonate, sodium antimonate and diantimony pentoxide) is considered justified.   No test item related changes were observed in a 90-day repeated dose toxicity study via oral route up to the limit dose of 1000 mg/kg bw/day with sodium hexahydroxoantimonate. The no-observed-effect level (NOEL) was above 1000 mg sodium hexahydroxoantimonate/kg b.w./day, p.o. for the male and female rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad9e197e-0f12-4969-9004-b8b6b6c1a1c3/documents/6d833c9e-925b-4d67-b1c5-292bfe3b5666_e3708ea5-c1b7-4257-a661-319a6ec55f0a.html,,,,,, Sodium hexahydroxoantimonate,33908-66-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ad9e197e-0f12-4969-9004-b8b6b6c1a1c3/documents/6d833c9e-925b-4d67-b1c5-292bfe3b5666_e3708ea5-c1b7-4257-a661-319a6ec55f0a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium hexahydroxoantimonate,33908-66-6," Acute toxicity, oral: LD50 > 2000 mg/kg bw Acute toxicity, inhalation: LC50 > 5.40 mg sodium hexahydroxoantimonate/L air Based on the results of the histopathological and macroscopic investigations, sodium hexahydroxoantimonate (and by read-across antimony pentoxide and sodium antimonate) does not require classification for respiratory irritation. Acute toxicity, dermal: Conduct of an acute dermal toxicity study is unjustified as inhalation of the substance is considered as major route of exposure and physicochemical properties of the substance do not suggest a significant rate of absorption through the skin (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ad9e197e-0f12-4969-9004-b8b6b6c1a1c3/documents/e42c71a8-cf9c-4285-aa03-aef8e04e8987_e3708ea5-c1b7-4257-a661-319a6ec55f0a.html,,,,,, "Sodium hydrogen [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]ferrate(2-)",12389-75-2," In an extended oral OECD 422 study male animals were exposed for at least 13 weeks and females for almost 14 weeks. At the high dose level the following effects were observed: soft faeces (both sexes), decreased body weight gain (males), prolonged prothrombin time (males), increased haemoglobin concentration (males), decreased ALAT activity and chloride concentration (males) and increased relative weights of kidneys and liver (both sexes). No toxicologically relevant changes were observed at the lower levels of 500 and 150 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79857e63-17f7-4037-a2fb-33d38e410977/documents/IUC5-8fadb94b-14d5-47a5-bd37-6359dd5228b9_14ac39a0-f932-45e2-914e-20c428fe3ccf.html,,,,,, "Sodium hydrogen [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]ferrate(2-)",12389-75-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/79857e63-17f7-4037-a2fb-33d38e410977/documents/IUC5-8fadb94b-14d5-47a5-bd37-6359dd5228b9_14ac39a0-f932-45e2-914e-20c428fe3ccf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Sodium hydrogen [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]ferrate(2-)",12389-75-2,"The oral LD50 value is in excess of 2000 mg/kg bw; the 4-h LC50 value is in excess of 5.08 g/m3. No acute dermal toxicity studies are available but based on read across (see also section 13), acute dermal toxicity following exposure to DTPA-FeHNa is not expected. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/79857e63-17f7-4037-a2fb-33d38e410977/documents/IUC5-fe2f4dca-fb1b-4f57-a61a-330a890a41fe_14ac39a0-f932-45e2-914e-20c428fe3ccf.html,,,,,, "Sodium hydrogen 8-aminonaphthalene-1,6-disulphonate",74543-22-9," Acute oral toxicity: LD50 was estimated to be 2517 mg/kg bw when Wistar male and female rats were orally exposed with sodium hydrogen 8-aminonaphthalene-1,6-disulfonate. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2b471c8-fdae-40bf-be00-e5716df7cae4/documents/c88dd167-44c5-40f0-a821-9ba8cef0333d_815afc61-2027-4137-81d9-f597df7b12b3.html,,,,,, "Sodium hydrogen 8-aminonaphthalene-1,6-disulphonate",74543-22-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2b471c8-fdae-40bf-be00-e5716df7cae4/documents/c88dd167-44c5-40f0-a821-9ba8cef0333d_815afc61-2027-4137-81d9-f597df7b12b3.html,,oral,LD50,"2,517 mg/kg bw",no adverse effect observed, Sodium hydrogendifluoride,1333-83-1,"The toxicity of sodium hydrogen difluoride will be dominated by local (site of contact) effects, as a consequence of its corrosive nature. Systemic exposure is likely to be limited, but systemic toxicity is predicted to be due to fluoride and the critical effect will be skeletal fluorosis. Comprehensive repeated dose oral toxicity data are available for sodium fluoride; read-across is therefore proposed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51cac7b5-6255-4d96-bb1a-0515c3bf66c8/documents/IUC5-4c0e1774-2e08-4288-b187-1298b0119544_76ec18c9-3e66-43a1-9fe6-5d591170a5db.html,,,,,, Sodium hydrogendifluoride,1333-83-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51cac7b5-6255-4d96-bb1a-0515c3bf66c8/documents/IUC5-4c0e1774-2e08-4288-b187-1298b0119544_76ec18c9-3e66-43a1-9fe6-5d591170a5db.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,1 mg/m3,,rat Sodium hydrogendifluoride,1333-83-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51cac7b5-6255-4d96-bb1a-0515c3bf66c8/documents/IUC5-4c0e1774-2e08-4288-b187-1298b0119544_76ec18c9-3e66-43a1-9fe6-5d591170a5db.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1 mg/m3,adverse effect observed,rat Sodium hydrogendifluoride,1333-83-1,"Waivers are appropriate for acute oral, dermal and inhalation toxicity as sodium hydrogen difluoride is a corrosive substance and additionally is already classified as Toxic if swallowed (H301) under CLP. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51cac7b5-6255-4d96-bb1a-0515c3bf66c8/documents/IUC5-4f3e5540-f89c-4000-9cbf-5411d6351364_76ec18c9-3e66-43a1-9fe6-5d591170a5db.html,,,,,, Sodium hydrogensulphide,16721-80-5,"In the key study, the 90-day inhalation toxicity study with exposure of rats and mice to hydrogen sulfide (Dorman et al., 2004), no toxicologically relevant alterations in haematological indices, serum chemistries, or gross pathology. Therefore, the highest concentration of 80 ppm H2S may be considered as NOAEC for systemic effects. When comparing the results of the available sub-chronic studies in rats and mice, it becomes obvious that the findings of these inhalation studies are not contradictory. Brennemann et al. (2000), Moulin et al. (2002) and Dorman et al. (2004) found similar targets of toxicity. The main adverse effect caused by 30 and 80 ppm hydrogen sulfide was an exposure-related increased incidence of olfactory neuronal loss (ONL). Thus, the concentration of 10 ppm H2S represents an NOAEC for local effects in the olfactory system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd0c5db8-991f-4f8f-83b0-9b70eba4c684/documents/IUC5-db410441-d77a-4dfc-b405-9ade132100dc_a599146a-cbee-4ca3-b6d5-aff1219e2db2.html,,,,,, Sodium hydrogensulphide,16721-80-5,"Acute oral toxicity: Acute oral toxicity of sodium hydrogensulfide is assessed from the key study (Kirsch, 1986), supported by the results from Kramer, Weigand, 1974. An LD50 value of 115 mg/kg could be derived for sodium hydrogensulfide (ca. 70 %) from the key study. The result indicates that the LD50 calculated for the most concentrated commercial form NaHS, 77 %, would be 105 mg/kg bw. An LD50 of 184 mg/kg bw was calculated from the supportive study for Sulfhydrat (sodium hydrogensulfide, ca. 30 %). The result indicate that the LD50 for NaHS, 77 %, would be 72 mg/kg bw. Two further oral studies were available for Sodium hydrogensulfide, however both were assessed as not reliable because of significant methological deficiencies or deficiencies in the documentation.Acute inhalation toxicity: No reliable studies available.Acute dermal toxicity: no reliable study available, since the Hollander & Weigand study (1974) is assessed as not reliable because the skin has been hurt during performance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd0c5db8-991f-4f8f-83b0-9b70eba4c684/documents/IUC5-3fc85f34-ebe2-42ca-bc30-99c6995f1e2f_a599146a-cbee-4ca3-b6d5-aff1219e2db2.html,,,,,, "Sodium metaborate, anhydrous",7775-19-1,"A number of oral sub-chronic and chronic studies on boric acid and disodium tetraborate decahydrate were carried out in rats, mice and dogs. In some cases, these studies are research studies (Weir and Fisher, 1972; Dixon et al, 1976; Seal and Weeth, 1980; Lee et al., 1978; Treinen and Chapin, 1991; Ku et al., 1993), but most support that boron can cause adverse haematological effects and that the main target organ of boron toxicity is the testis. The NOAEL for fertility effects is equivalent to 17.5 mg B/kg bw/day (Weir, 1966) that corresponds to a NOAEL of 106.5 mg Sodium metaborate/kg bw/day (anhydrous, 164.8 mg Sodium metaborate dihydrate/kg bw/day and 223.2 mg Sodium metaborate tetrahydrate/kg bw/day).  Based on the sub-acute inhalation study on boron oxide conducted in rats (Wilding, 1960), the NOAEC for systemic effects is equivalent to 146 mg B/m3 that corresponds to a NOAEC of 888.6 mg Sodium metaborate /m3 (anhydrous, 1374.8 mg Sodium metaborate dihydrate/m3 and 1862.2 mg Sodium metaborate tetrahydrate/m3). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study meets generally accepted scientific standards with acceptable restrictions. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f29e24a4-74ae-4480-9ece-e332a91bfe91/documents/IUC5-ca0a458d-fb28-449f-a594-9d4165a92697_218d87e7-29c3-4e58-b853-6da9f240feec.html,,,,,, "Sodium metaborate, anhydrous",7775-19-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f29e24a4-74ae-4480-9ece-e332a91bfe91/documents/IUC5-ca0a458d-fb28-449f-a594-9d4165a92697_218d87e7-29c3-4e58-b853-6da9f240feec.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,888.6 mg/m3,, "Sodium metaborate, anhydrous",7775-19-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f29e24a4-74ae-4480-9ece-e332a91bfe91/documents/IUC5-ca0a458d-fb28-449f-a594-9d4165a92697_218d87e7-29c3-4e58-b853-6da9f240feec.html,Chronic toxicity – systemic effects,oral,NOAEL,106.5 mg/kg bw/day,,rat "Sodium metaborate, anhydrous",7775-19-1,"Acute oral studies have been performed with sodium metaborate (tetrahydrate and dihydrate), disodium tetraborate, sodium tetraborate pentahydrate, sodium tetraborate decahydrate and boric acid. Acute dermal and inhalation studies have been performed with disodium tetraborate pentahydrate, disodium tetraborate decahydrate and boric acid. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): High quality (there are a lot of reliable studies for different boron species available). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): High quality (there are a lot of reliable studies for different boron species available). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): High quality (there are a lot of reliable studies for different boron species available). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f29e24a4-74ae-4480-9ece-e332a91bfe91/documents/IUC5-a0a2749c-9a8a-40ef-adc9-defca0e5f17b_218d87e7-29c3-4e58-b853-6da9f240feec.html,,,,,, "Sodium metaborate, anhydrous",7775-19-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f29e24a4-74ae-4480-9ece-e332a91bfe91/documents/IUC5-a0a2749c-9a8a-40ef-adc9-defca0e5f17b_218d87e7-29c3-4e58-b853-6da9f240feec.html,,oral,LD50,"2,330 mg/kg bw",no adverse effect observed, "Sodium metaborate, anhydrous",7775-19-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f29e24a4-74ae-4480-9ece-e332a91bfe91/documents/IUC5-a0a2749c-9a8a-40ef-adc9-defca0e5f17b_218d87e7-29c3-4e58-b853-6da9f240feec.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sodium metaborate, anhydrous",7775-19-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f29e24a4-74ae-4480-9ece-e332a91bfe91/documents/IUC5-a0a2749c-9a8a-40ef-adc9-defca0e5f17b_218d87e7-29c3-4e58-b853-6da9f240feec.html,,inhalation,LC50,"2,030 mg/m3",no adverse effect observed, Sodium metavanadate,13718-26-8,"Description of key information - soluble vanadium substances group (oral) A comprehensive literature search was recently conducted for the vanadium category substances, to source relevant information for the hazard and risk assessment. For the group of the soluble vanadium substances, a limited number of studies is available, and the different experimental approaches lead to a variety of endpoints measured. Of the limited effects noted following oral exposure with soluble vanadium substances, it appears most likely that effects on haematological parameters are the most consistently reported among a number of investigators (Mountain et al 1953, Zaporowska et al. 1993, Scibior et al 2006, Scibior, 2005, NTP, 2002, NTP, 2023). Altogether, haematological effects have been found with a variety of different vanadium compounds including sodium metavanadate, vanadium pentoxide, and ammonium metavanadate supporting the use of this endpoint for risk assessment purposes. Furthermore, epithelial hyperplasia in the small intestine of rats and mice were observed after the administration of sodium metavanadate and vanadyl sulfate (NTP, 2023). Therefore, this endpoint should also be considered for risk assessment purposes. Information on repeated dose toxicity following inhalation exposure to divanadium pentaoxide is available in a NTP study (k_NTP 2002) with exposure of male and female rats and mice to V2O5 over 16-days, 3-months and 2-years. Pulmonary reactivity to divanadium pentaoxide was also investigated following subchronic inhalation exposure in a non-human primate animal model. Data of the repeated-dose toxicity via the dermal route are not available for any vanadium substance. Following the HERAG guidance for metals and metal salts (see section 7.1.2 of the technical dossier: dermal absorption), negligible percutaneous uptake based on minimal penetration, i.e. a dermal absorption rate in the range of maximally 0.1 - 1.0 %, can be anticipated. Dermal absorption in this order of magnitude is not considered to be “significant”. Thus, regarding repeated-dose toxicity of vanadium substances, the dermal exposure route is not expected to be the most relevant. EBRC (2007) HERAG fact sheet - Assessment of occupational dermal exposure and dermal absorption for metals and inorganic metal compounds, EBRC Consulting GmbH, Hannover, Germany, August 2007, 49 pages.   Further information: Divanadium pentaoxide has been excluded from the soluble vanadium substances read-across group due to its legal classification. Thus, studies conducted with divanadium pentaoxide are reported for information purposes only. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce43154f-9d3e-4414-afb3-654587c0d811/documents/IUC5-a18aabf6-3a06-4f13-9043-c33309677751_db67c0e2-5fee-4b43-9465-778aa7870b5d.html,,,,,, Sodium metavanadate,13718-26-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce43154f-9d3e-4414-afb3-654587c0d811/documents/IUC5-a18aabf6-3a06-4f13-9043-c33309677751_db67c0e2-5fee-4b43-9465-778aa7870b5d.html,Repeated dose toxicity – local effects,inhalation,LOAEC,0.5 mg/m3,adverse effect observed,rat Sodium metavanadate,13718-26-8, Acute oral toxicity: LD50 = 169 mg/kg bw (OECD 401; GLP; female rats) Acute inhalation toxicity: LC50 = 3.73 mg/ L air (OECD 403; GLP; female rats) Acute dermal toxicity: LD50 > 2500 mg/kg bw (OECD 402; GLP; read-across from potassium vanadium trioxide) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce43154f-9d3e-4414-afb3-654587c0d811/documents/IUC5-b186a6d7-d47e-4a36-97f3-03b5fdc849de_db67c0e2-5fee-4b43-9465-778aa7870b5d.html,,,,,, Sodium metavanadate,13718-26-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce43154f-9d3e-4414-afb3-654587c0d811/documents/IUC5-b186a6d7-d47e-4a36-97f3-03b5fdc849de_db67c0e2-5fee-4b43-9465-778aa7870b5d.html,,oral,LD50,169 mg/kg bw,adverse effect observed, Sodium metavanadate,13718-26-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce43154f-9d3e-4414-afb3-654587c0d811/documents/IUC5-b186a6d7-d47e-4a36-97f3-03b5fdc849de_db67c0e2-5fee-4b43-9465-778aa7870b5d.html,,dermal,discriminating dose,"2,500 mg/kg bw",no adverse effect observed, Sodium metavanadate,13718-26-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce43154f-9d3e-4414-afb3-654587c0d811/documents/IUC5-b186a6d7-d47e-4a36-97f3-03b5fdc849de_db67c0e2-5fee-4b43-9465-778aa7870b5d.html,,inhalation,LC50,"3,730 mg/m3",adverse effect observed, Sodium methanesulphonate,2386-57-4," Acute oral toxicity The single-dose oral toxicity study with Sodium methanesulfonate was performed according to the acute toxic class method (OECD 423 and Commission Regulation (EC) No 440/2008 of 30 May 2008, B.1.Tris) in Crl:WI rats. Two groups of three female Crl:WI rats were treated with the test item at a dose level of 2000 mg/kg bw (Group 1 and Group 2). A single oral treatment was carried out by gavage for each animal after an overnight food withdrawal. Food was made available again 3 hours after the treatment. The test item was administered at the dose level of 2000 mg/kg body weight (equivalent to 4.23 mL/kg bw of SPS10LS). Initially, three females (Group 1) were treated at a dose level of 2000 mg/kg bw. As no mortality was observed, a confirmatory group (Group 2) was treated at the same dose level. No mortality was observed in the confirmatory group; therefore no further testing was required according to OECD 423 and Commission Regulation (EC) NO 440/2008 of 30 May 2008, B.1.Tris. Clinical observations were performed at 30 minutes, 1, 2, 3, 4 and 6 hours after dosing and daily for 14 days thereafter. Body weight was measured on Days -1, 0, 7 and before necropsy (Day 14). All animals were subjected to a necropsy and a macroscopic examination. Sodium methanesulfonate did not cause mortality at a dose level of 2000 mg/kg bw. All animals were symptom free during the study. Body weight gains of Sodium methanesulfonate treated animals during the study showed no indication of a test item-related effect. There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw. Under the conditions of this study, the acute oral LD0 value of the test item Sodium methanesulfonate was found to be equal to or above 2000 mg/kg bw in female Crl:WI rats. Acute dermal toxicity An acute dermal toxicity study was performed with test item Sodium methanesulfonate in Crl:WI rats, in compliance with OECD Guideline No.: 402. A limit test was carried out at 2000 mg Sodium methanesulfonate/kg body weight (equivalent to 4.23 mL/kg bw of SPS10LS) in both sexes (5 rats/sex). The test item was applied as a single dermal 24-hour exposure followed by a 14-day observation period. Clinical observations were performed on all animals at 1 and 5 hours after dosing and daily for 14 days thereafter. Body weight was measured prior to dosing on Day 0 and on Days 7 and 14. Gross macroscopic examination was performed on all animals at the end of the 2-week observation period (Day 14). Sodium methanesulfonate did not cause mortality at the dose level of 2000 mg/kg bw. There were no systemic clinical signs noted in any animal throughout the study. No local dermal signs were observed after treatment with the test item during the 14 days observation period. Body weight gains of Sodium methanesulfonate treated animals during the study showed no indication of a test item-related effect.There was no evidence of the macroscopic observations at a dose level of 2000 mg/kg bw. Under the conditions of this study, the acute dermal lethal dose (LD0 value) of the test item Sodium methanesulfonate was found to be equal to or above 2000 mg/kg bw in male and female Crl:WI rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/561d8642-0f58-46a2-a265-d42606d59f76/documents/0277fbb1-330e-4eaf-8fc7-539bf98ff87d_dfd0f1bf-f8e0-44c0-b0cb-7cad8caa392a.html,,,,,, Sodium methanesulphonate,2386-57-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/561d8642-0f58-46a2-a265-d42606d59f76/documents/0277fbb1-330e-4eaf-8fc7-539bf98ff87d_dfd0f1bf-f8e0-44c0-b0cb-7cad8caa392a.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Sodium methanesulphonate,2386-57-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/561d8642-0f58-46a2-a265-d42606d59f76/documents/0277fbb1-330e-4eaf-8fc7-539bf98ff87d_dfd0f1bf-f8e0-44c0-b0cb-7cad8caa392a.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Sodium methanethiolate,5188-07-8," In two acute oral toxicity studies conducted according to OECD TG 401, male and female Sprague-Dawley rats were given a single oral dose of formulated Sodium methanethiolate in water and were observed for 14 days. Based on the results and in accordance with OECD guideline 401 in the first and second acute oral toxicity study the oral LD50 was determined to be 116 and 109 mg/kg bw, respectively. Thus, the substance meets the criteria of the CLP Regulation 1272/2008 for being classified as Acute Tox. 3, H301. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b74449a6-a3a3-4353-ba7f-e33b26107b77/documents/af0226ea-b22f-46da-b6d0-2a1464935d4f_0926d24f-2776-4920-936b-04241595cbfa.html,,,,,, Sodium methanethiolate,5188-07-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b74449a6-a3a3-4353-ba7f-e33b26107b77/documents/af0226ea-b22f-46da-b6d0-2a1464935d4f_0926d24f-2776-4920-936b-04241595cbfa.html,,oral,LD50,109 mg/kg bw,adverse effect observed, Sodium methanolate,124-41-4," Sodium methanolate is classified as corrosive to the skin according to Annex VI of the CLP regulation (EC 1272/2008). At non-irritant concentrations / dose levels, no systemic effects are expected after repeated exposure to sodium methanolate via any route. It is unlikely that exposure to sodium methanolate at non-irritant concentrations / dose levels would result in exposure to toxic doses of the hydrolysis / dissociation products, in particular methanol. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d24c764-ae17-4ebc-a043-823c65cc9290/documents/IUC5-592b63a6-e544-4def-abd4-a8fdab1560ae_7669d52d-0e69-4221-bc54-0a408e0ad32d.html,,,,,, Sodium methanolate,124-41-4,Oral: LD50 (rat) in water or water soluble solvents: 800 - 1687 mg/kg bwDermal: LD50 (rat): > 2000 mg/kg bw (50% aqueous solution) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d24c764-ae17-4ebc-a043-823c65cc9290/documents/IUC5-2462b1ee-fc48-48db-8354-0b8bdda83279_7669d52d-0e69-4221-bc54-0a408e0ad32d.html,,,,,, Sodium methanolate,124-41-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d24c764-ae17-4ebc-a043-823c65cc9290/documents/IUC5-2462b1ee-fc48-48db-8354-0b8bdda83279_7669d52d-0e69-4221-bc54-0a408e0ad32d.html,,oral,LD50,"1,687 mg/kg bw",adverse effect observed, Sodium methyl sulphate,512-42-5," LD50, oral, rat > 2000 mg/kg bw (BASF SE, 2017) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da2f11d5-d127-4ee2-998f-db93e8bafe6f/documents/9eab71aa-e6fb-42bc-9651-fa94929c6f0e_709a69a9-2793-4fb8-a266-1a4419c37cbf.html,,,,,, Sodium methyl sulphate,512-42-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da2f11d5-d127-4ee2-998f-db93e8bafe6f/documents/9eab71aa-e6fb-42bc-9651-fa94929c6f0e_709a69a9-2793-4fb8-a266-1a4419c37cbf.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate,94441-92-6,"A 28 day oral toxicity study performed according to OECD Guideline 407 and under GLP with Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6 is available, with reliability rating 1. Based on the absence of functional or morphological disturbances supporting the changes noted in the study, a NOAEL of > 1000 mg/kg was established. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f28008b3-386e-427e-bb23-a9d197089544/documents/IUC5-da3831dc-2f31-4663-8360-7629c9f1c06a_a1050700-44e6-4fc1-96e4-d9c74b17c88f.html,,,,,, Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate,94441-92-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f28008b3-386e-427e-bb23-a9d197089544/documents/IUC5-da3831dc-2f31-4663-8360-7629c9f1c06a_a1050700-44e6-4fc1-96e4-d9c74b17c88f.html,Short-term repeated dose toxicity – systemic effects,oral,,"1,000 mg/kg bw/day",,rat Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate,94441-92-6,"The oral LD50 study on Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6 has reliability rating 2 and the procedure used meets the requirements of the limit test for acute oral toxicity described by the OECD Guideline 401. The results of this GLP compliant study indicate that the test material has little toxic effect when administered as a single oral dose to the rat at a dose level of 5000 mg/kg bw. The test material used consists of 40% active ingredient and 60% water. As the oral LD50 of the product is > 5000 mg/kg bw, the LD50 of the active ingredient is considered to be > 2000 mg/kg bw. The dermal LD50 study (OECD Guideline 402) on Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6 is performed according to GLP and has reliability rating 1. It is therefore considered acceptable for classification and labelling purposes. The LD50 of the active ingredient is considered to be > 2000 mg/kg bw, and it does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f28008b3-386e-427e-bb23-a9d197089544/documents/IUC5-eb605850-4e5b-4f66-a581-abfe2760a879_a1050700-44e6-4fc1-96e4-d9c74b17c88f.html,,,,,, Sodium naphthalene-1-sulphonate,130-14-3," Repeated dose toxicity: Oral The no observed adverse effect level (NOAEL) for sodium naphthalene-1-sulfonate (CAS no.: 130-14-3) is considered to be 1300 mg/kg/day. Repeated dose toxicity: Inhalation Sodium naphthalene-1-sulphonate (CAS No. 130-14-3) has a particle size distribution to be in the range of 150 micron to 10 micron. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely. Therefore this end point for repeated dose toxicity by inhalation route is considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value for Sodium naphthalene-1-sulphonate (CAS No. 130-14-3) (as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/954b0611-5bdd-404e-8d41-2c09607b891d/documents/323675a4-08c3-48a4-9a3c-7f4586ff8901_c1750639-d557-4482-84b5-07295e27dbb7.html,,,,,, Sodium naphthalene-1-sulphonate,130-14-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/954b0611-5bdd-404e-8d41-2c09607b891d/documents/323675a4-08c3-48a4-9a3c-7f4586ff8901_c1750639-d557-4482-84b5-07295e27dbb7.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,300 mg/kg bw/day",,mouse Sodium naphthalene-1-sulphonate,130-14-3," Acute oral Toxicity:  The acute oral toxicity dose (LD50) for sodium naphthalene-1-sulfonate (130-14-3) was based on data available for the structurally similar read across chemicals. The LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, sodium naphthalene-1-sulfonate (130-14-3)cannot be classified for acute oral toxicity.  Acute Inhalation Toxicity:  Sodium naphthalene-1-sulphonate (CAS No. 130-14-3) has a particle size distribution to be in the range of 150 micron to 10 micron. The normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely. Therefore this end point for single dose toxicity by inhalation route is considered for waiver. Acute dermal Toxicity:  The acute dermal toxicity dose (LD50) for sodium naphthalene-1-sulfonate (130-14-3) was based on data available for the structurally similar read across chemicals. The LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, sodium naphthalene-1-sulfonate (130-14-3) cannot be classified for acute dermal toxicity.  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/954b0611-5bdd-404e-8d41-2c09607b891d/documents/8b027d19-4959-4a1c-a84a-0f084151e37e_c1750639-d557-4482-84b5-07295e27dbb7.html,,,,,, Sodium naphthalene-1-sulphonate,130-14-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/954b0611-5bdd-404e-8d41-2c09607b891d/documents/8b027d19-4959-4a1c-a84a-0f084151e37e_c1750639-d557-4482-84b5-07295e27dbb7.html,,oral,LD50,"13,900 mg/kg bw",no adverse effect observed, Sodium naphthalene-1-sulphonate,130-14-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/954b0611-5bdd-404e-8d41-2c09607b891d/documents/8b027d19-4959-4a1c-a84a-0f084151e37e_c1750639-d557-4482-84b5-07295e27dbb7.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium N-chlorobenzenesulphonamide,127-52-6,"A 28-day oral gavage dose range finding study with Chloramine B was performed in rats at dose levels of 50, 100, 200 and 300 mg/kg bw/day. Based on the results, Chloramine B was then tested in a key 90 -day oral gavage toxicity study at dose levels 20, 60, 180 mg/kg bw/day. The LOAEL was 60 mg/kg bw/day, whereas NOAEL was 20 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/530e1e95-ac6c-40d0-8992-7af348b26760/documents/IUC5-f00be76a-5f0b-432d-bd73-a2103712a414_934ed205-3478-4323-9a34-e366986fc2e5.html,,,,,, Sodium N-chlorobenzenesulphonamide,127-52-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/530e1e95-ac6c-40d0-8992-7af348b26760/documents/IUC5-f00be76a-5f0b-432d-bd73-a2103712a414_934ed205-3478-4323-9a34-e366986fc2e5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat Sodium N-chlorobenzenesulphonamide,127-52-6,"Key studies were available for acute oral and dermal toxicity testing with Chloramine B trihydrate. Acute Toxic Class oral testing in female rats resulted in LD50 between 300 mg/kg bw (no animals died) and 2000 mg/kg bw (all animals died). At 300 mg/kg bw, very mild clinical signs of intoxication (erected hair, hunched posture) were seen in 3 animals and liver dystrophy was seen at pathology in 3 other animals. Acute inhalation toxicity testing was waived based on low vapour pressure and large particle size. Acute dermal toxicity testing in rats resulted in LD50>2000 mg/kg bw. No clinical signs of toxicity were observed during the study, except for symptoms of skin irritation which were almost healed. Macroscopic changes included skin crusts and granular surface of the spleen in all animals. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/530e1e95-ac6c-40d0-8992-7af348b26760/documents/IUC5-9af9f998-8952-431c-a86c-731f251f2b24_934ed205-3478-4323-9a34-e366986fc2e5.html,,,,,, Sodium N-chlorobenzenesulphonamide,127-52-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/530e1e95-ac6c-40d0-8992-7af348b26760/documents/IUC5-9af9f998-8952-431c-a86c-731f251f2b24_934ed205-3478-4323-9a34-e366986fc2e5.html,,oral,LD50,"1,150 mg/kg bw",adverse effect observed, Sodium N-chlorobenzenesulphonamide,127-52-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/530e1e95-ac6c-40d0-8992-7af348b26760/documents/IUC5-9af9f998-8952-431c-a86c-731f251f2b24_934ed205-3478-4323-9a34-e366986fc2e5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium nonyl sulphate,1072-15-7,For the whole category of alkyl sulfates (AS) a NOAEL of 488 mg/kg bw/day for oral and dermal exposure was established. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bc9d56c-4917-44d9-af74-245fa166381f/documents/IUC5-f91c4bc4-c399-47f4-9f2f-59448b59b0f3_7a677865-8bbb-4598-9433-028aa246686e.html,,,,,, Sodium nonyl sulphate,1072-15-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bc9d56c-4917-44d9-af74-245fa166381f/documents/IUC5-f91c4bc4-c399-47f4-9f2f-59448b59b0f3_7a677865-8bbb-4598-9433-028aa246686e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,488 mg/kg bw/day,,rat Sodium nonyl sulphate,1072-15-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bc9d56c-4917-44d9-af74-245fa166381f/documents/IUC5-f91c4bc4-c399-47f4-9f2f-59448b59b0f3_7a677865-8bbb-4598-9433-028aa246686e.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,,mouse Sodium nonyl sulphate,1072-15-7,"Oral LD50 (OECD guideline 401), rat = 1200 mg/kg bwDermal LD50 (OECD guideline 402), rabbit >= 2000 mg/kg bw (limit test) Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bc9d56c-4917-44d9-af74-245fa166381f/documents/IUC5-6cb1a9f1-33bc-41ea-8624-cd337ff37fd6_7a677865-8bbb-4598-9433-028aa246686e.html,,,,,, Sodium nonyl sulphate,1072-15-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bc9d56c-4917-44d9-af74-245fa166381f/documents/IUC5-6cb1a9f1-33bc-41ea-8624-cd337ff37fd6_7a677865-8bbb-4598-9433-028aa246686e.html,,oral,LD50,"1,200 mg/kg bw",adverse effect observed, Sodium nonyl sulphate,1072-15-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bc9d56c-4917-44d9-af74-245fa166381f/documents/IUC5-6cb1a9f1-33bc-41ea-8624-cd337ff37fd6_7a677865-8bbb-4598-9433-028aa246686e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sodium O,O-diethyl dithiophosphate",3338-24-7,"Repeated dose 90-day oral toxicity study (OECD 408, read-across structural analogue): NOAEL for systemic toxicity, rats: 600 mg/kg bw/d ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f74dc0c-170c-4a78-a5b6-cf8d867b3506/documents/IUC5-694164c1-7aaf-4482-b381-5bc778311b87_3811ee48-9131-4e50-9b3c-1dfc8b1717da.html,,,,,, "Sodium O,O-diethyl dithiophosphate",3338-24-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3f74dc0c-170c-4a78-a5b6-cf8d867b3506/documents/IUC5-694164c1-7aaf-4482-b381-5bc778311b87_3811ee48-9131-4e50-9b3c-1dfc8b1717da.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat "Sodium O,O-diethyl dithiophosphate",3338-24-7,"Acute toxicity studies have not been conducted because the substance is classified as corrosive to the skin and is a strong base (pH > 11.5) in accordance with REACH Annex VII, 8.3., column 2. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f74dc0c-170c-4a78-a5b6-cf8d867b3506/documents/83daa1b3-d771-4ec0-8585-3545b10e3ea6_3811ee48-9131-4e50-9b3c-1dfc8b1717da.html,,,,,, "Sodium O,O-diisopropyl dithiophosphate",27205-99-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): high quality ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/336eeabd-637a-4649-b590-48bf64d7513d/documents/8b0e0f9b-3f01-4bae-824b-1336efb5589b_2deec312-94c6-4277-856c-111854c02483.html,,,,,, "Sodium O,O-diisopropyl dithiophosphate",27205-99-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/336eeabd-637a-4649-b590-48bf64d7513d/documents/8b0e0f9b-3f01-4bae-824b-1336efb5589b_2deec312-94c6-4277-856c-111854c02483.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Sodium O,O-di-sec-butyl dithiophosphate",33619-92-0,"Read-across (IBP1-Na) OECD 422: Effects on the F0-generation NOAEL (no-observed-adverse-effect level): 200 mg IBP1-Na/kg b.w./day, p.o.Effects on reproduction NOAEL (no-observed-adverse-effect level): 600 mg IBP1-Na/kg b.w./day, p.o. OECD 408: The no-observed-adverse effect level (NOAEL) was established at 600 mg/kg bw/day in males and female rats.   Read-across (EP1-Na) OECD 422: Based on these observations the NOAEL for systemic toxicity of male/female rats was 1000 mg/kg bw/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): high quality ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7688179b-64f4-4fe6-8ac8-a94cbafaa5b5/documents/b845d8e1-8bc4-4fd0-ac2b-7d3664452857_081e3280-a2c7-432d-a474-2493322ce3f9.html,,,,,, "Sodium O,O-di-sec-butyl dithiophosphate",33619-92-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7688179b-64f4-4fe6-8ac8-a94cbafaa5b5/documents/b845d8e1-8bc4-4fd0-ac2b-7d3664452857_081e3280-a2c7-432d-a474-2493322ce3f9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Sodium O,O-di-sec-butyl dithiophosphate",33619-92-0,"The studies have not been conducted because the substance is classified as corrosive to the skin and is a strong base (pH > 11.5) in accordance with REACH Annex VII, 8.3., column 2. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7688179b-64f4-4fe6-8ac8-a94cbafaa5b5/documents/72c6f591-4a34-434e-951e-4ae5d34e611d_081e3280-a2c7-432d-a474-2493322ce3f9.html,,,,,, Sodium octyl sulphate,142-31-4,For the whole category of alkyl sulfates (AS) a NOAEL of 488 mg/kg bw/day was established. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c09ef2d-6881-4a40-ae7e-808486dcb9f6/documents/IUC5-37ea23f1-d408-475c-8112-8f8f7517beaa_278842e1-8791-4b1a-b572-15d15e9c8fba.html,,,,,, Sodium octyl sulphate,142-31-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c09ef2d-6881-4a40-ae7e-808486dcb9f6/documents/IUC5-37ea23f1-d408-475c-8112-8f8f7517beaa_278842e1-8791-4b1a-b572-15d15e9c8fba.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,488 mg/kg bw/day,,rat Sodium octyl sulphate,142-31-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c09ef2d-6881-4a40-ae7e-808486dcb9f6/documents/IUC5-37ea23f1-d408-475c-8112-8f8f7517beaa_278842e1-8791-4b1a-b572-15d15e9c8fba.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,,mouse Sodium octyl sulphate,142-31-4,"Oral LD50 (OECD guideline 423), rat > 2000 mg/kg bwDermal LD50 (OECD guideline 402), rabbit > 2000 mg/kg bw (limit test) Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c09ef2d-6881-4a40-ae7e-808486dcb9f6/documents/IUC5-aafbd6c9-b14d-41e3-b84e-cbb164baf157_278842e1-8791-4b1a-b572-15d15e9c8fba.html,,,,,, Sodium octyl sulphate,142-31-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c09ef2d-6881-4a40-ae7e-808486dcb9f6/documents/IUC5-aafbd6c9-b14d-41e3-b84e-cbb164baf157_278842e1-8791-4b1a-b572-15d15e9c8fba.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Sodium octyl sulphate,142-31-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c09ef2d-6881-4a40-ae7e-808486dcb9f6/documents/IUC5-aafbd6c9-b14d-41e3-b84e-cbb164baf157_278842e1-8791-4b1a-b572-15d15e9c8fba.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium O-ethyl dithiocarbonate,140-90-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Inhalation of potassium amyl xanthate produces adverse effects in the livers of dogs. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c28bd383-afc0-465b-89bf-8c3876bb5414/documents/IUC5-42a110f7-4a34-40dd-8c0c-d6198f60ac35_93e47db9-82a1-4a4a-a642-67a263a6e682.html,,,,,, Sodium O-ethyl dithiocarbonate,140-90-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c28bd383-afc0-465b-89bf-8c3876bb5414/documents/IUC5-42a110f7-4a34-40dd-8c0c-d6198f60ac35_93e47db9-82a1-4a4a-a642-67a263a6e682.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,100 mg/m3,,dog Sodium O-ethyl dithiocarbonate,140-90-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c28bd383-afc0-465b-89bf-8c3876bb5414/documents/IUC5-42a110f7-4a34-40dd-8c0c-d6198f60ac35_93e47db9-82a1-4a4a-a642-67a263a6e682.html,Chronic toxicity – systemic effects,oral,LOAEL,10 mg/kg bw/day,,rat Sodium O-ethyl dithiocarbonate,140-90-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c28bd383-afc0-465b-89bf-8c3876bb5414/documents/IUC5-a1a6e8bc-00bd-43c0-851a-3d2889f03e98_93e47db9-82a1-4a4a-a642-67a263a6e682.html,,oral,LD50,730 mg/kg bw,adverse effect observed, Sodium O-ethyl dithiocarbonate,140-90-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c28bd383-afc0-465b-89bf-8c3876bb5414/documents/IUC5-a1a6e8bc-00bd-43c0-851a-3d2889f03e98_93e47db9-82a1-4a4a-a642-67a263a6e682.html,,inhalation,LC50,"7,690 mg/m3",adverse effect observed, Sodium O-isobutyl dithiocarbonate,25306-75-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Inhalation of potassium amyl xanthate produces adverse effects in the livers of dogs. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3156c281-ead8-48c1-ae81-5ce7c7ea66f1/documents/IUC5-771003ac-fe83-4e3c-98a6-32977fc81625_b400dcfe-f758-423f-ad1d-75301b0827f0.html,,,,,, Sodium O-isobutyl dithiocarbonate,25306-75-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3156c281-ead8-48c1-ae81-5ce7c7ea66f1/documents/IUC5-771003ac-fe83-4e3c-98a6-32977fc81625_b400dcfe-f758-423f-ad1d-75301b0827f0.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,100 mg/m3,,dog Sodium O-isobutyl dithiocarbonate,25306-75-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3156c281-ead8-48c1-ae81-5ce7c7ea66f1/documents/IUC5-771003ac-fe83-4e3c-98a6-32977fc81625_b400dcfe-f758-423f-ad1d-75301b0827f0.html,Chronic toxicity – systemic effects,oral,LOAEL,10 mg/kg bw/day,,rat Sodium O-isobutyl dithiocarbonate,25306-75-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Note that acute oral toxicity has been assess on the range of substances and with the exception of one mouse study, all are in the Acute Toxic 4 category. The quality of the data base is considered sufficient for the purposes of classification and risk management. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3156c281-ead8-48c1-ae81-5ce7c7ea66f1/documents/IUC5-57cf92f8-19c4-4813-a3ce-2d0269adb17c_b400dcfe-f758-423f-ad1d-75301b0827f0.html,,,,,, Sodium O-isobutyl dithiocarbonate,25306-75-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3156c281-ead8-48c1-ae81-5ce7c7ea66f1/documents/IUC5-57cf92f8-19c4-4813-a3ce-2d0269adb17c_b400dcfe-f758-423f-ad1d-75301b0827f0.html,,oral,LD50,ca.500 mg/kg bw,adverse effect observed, Sodium O-isobutyl dithiocarbonate,25306-75-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3156c281-ead8-48c1-ae81-5ce7c7ea66f1/documents/IUC5-57cf92f8-19c4-4813-a3ce-2d0269adb17c_b400dcfe-f758-423f-ad1d-75301b0827f0.html,,inhalation,LC50,"7,690 mg/m3",adverse effect observed, Sodium Olivoyl Glutamate,1628321-85-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d6dabc8-f4fb-404b-b224-50fc30e9c408/documents/4a84aa37-5bbf-4f03-8567-ed2cb689a8bd_00aa2eac-7c09-4d7d-b564-e38839728537.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sodium p-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]benzenesulphonate",4156-21-2," No clinical signs or alterations in food consumption, body weights, sensory activity, grip strength, locomotor activity, hematology, coagulation and biochemistry parameters were recorded attributed to the treatment at any do Granofin Easy F-90 was administered orally (by gavage) to Wistar rats once daily for 90 days. Four treatment groups were established, each containing 10 males and 10 females and they weere dosed at 1, 10, 50 and 100 mg/Kg bw. No clinical signs or alterations in food consumption, body weights, sensory activity, grip strength, locomotor activity, hematology, coagulation and biochemistry parameters were recorded attributed to the treatmentat any dose.No treatment-related macroscopic or microscopic alterations or alterations in organ weights were observed.No treatment-related macroscopic or microscopic alterations or alterations in organ weights were observed.  No clinical signs or alterations in food consumption, body weights, sensory activity, grip strength, locomotor activity, hematology, coagulation and biochemistry parameters were recorded attributed to the treatment.  No treatment-related macroscopic or microscopic alterations or alterations in organ weights were observed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db894202-5f1f-4b7e-9574-7d5af5951435/documents/IUC5-40886696-770b-467c-ae63-2d935d59d8f7_92057644-918c-43b7-853b-8004bd7c0937.html,,,,,, "Sodium p-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]benzenesulphonate",4156-21-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db894202-5f1f-4b7e-9574-7d5af5951435/documents/IUC5-40886696-770b-467c-ae63-2d935d59d8f7_92057644-918c-43b7-853b-8004bd7c0937.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Sodium p-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]benzenesulphonate",4156-21-2,No toxic effects at all were detected after acute oral administration to female rats in a study according to current guideline. The substance is of low toxicity after acute oral or dermal application. No reliable studies on toxicity after inhalation are available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db894202-5f1f-4b7e-9574-7d5af5951435/documents/IUC5-97776452-e9b4-4797-a861-f493368731de_92057644-918c-43b7-853b-8004bd7c0937.html,,,,,, "Sodium p-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]benzenesulphonate",4156-21-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db894202-5f1f-4b7e-9574-7d5af5951435/documents/IUC5-97776452-e9b4-4797-a861-f493368731de_92057644-918c-43b7-853b-8004bd7c0937.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium p-cumenesulphonate,15763-76-5,"The HYDROTOPES Category comprises the following 6 substances: STS - Sodium toluene 4-sulphonate (CAS 657-84-1, EC 211-522-5)SXS - Sodium (xylenes and 4-ethylbenzene) sulfonates (EC 701-037-1)NH4XS - Ammonium (xylenes and 4-ethylbenzene) sulfonates (EC 943-024-5)SCS - Sodium p-cumenesulphonate (CAS 15763-76-5, EC 239-854-6)KCS - Potassium p-cumenesulphonate (CAS 164524-02-1, EC 629-764-9)NH4CS - Ammonium p-cumenesulphonate (CAS 680972-33-2, EC 811-484-5)  In addition CaXS (Calcium Xylenesulphonate, CAS 28088-63-3, EC 248-829-9) was evaluated for complete the assessment despite it is not registered under REACH. There are many oral repeated dose toxicity studies on the three subgroups of hydrotrope category (toluene, xylene and cumene). Most of these studies were conducted on Sodium (xylenes and 4-ethylbenzene) sulphonate however there are reliable subacute studies on Sodium toluene 4-sulphonate and a sub-chronic study on Sodium p-cumene sulphonate. The key oral study is the 90 day sub-chronic study, conducted in 1968 on Sodium (xylenes and 4-ethylbenzene) sulphonate, which is generally comparable to the OECD 408 guideline study. In that study, the highest dose for female rats - 4092 mg active ingredient (a.i.) per kilogram body weight - resulted in a loss in relative weight of the spleen. The 2nd highest dose for females - 763 mg a.i. per kilogram body weight - had no measureable adverse effects and therefore establishes the repeat dose oral NOAEL for the substance. The highest oral dose for male rats - 3534 mg a.i. per kilogram body weight - had no measurable adverse effects. No adverse effects were reported in the other available 90 day sub-chronic study on rat and mouse. There is also a 28 days oral exposure study on sodium toluene 4-sulphonate which does not show any effect with a NOAEL of 1000 mg/kg bw (highest dose tested).   The key dermal studies are the two sub-chronic studies in rat and mouse performed as part of chronic carcinogenicity study (2 -years) performed on Sodium (xylenes and 4-ethylbenzene) sulfonates. No animals died in these studies, minimal hyperplasia of the epidermis at the site of application occurred in male and female rats from the control groups as well as most dosed groups. The incidence of epidermal hyperplasia in 400 mg/mL males was considered to be possibly chemical-related. For mice, hyperplasia of the epidermis at the site of application occurred in male and female mice from the highest dose tested group. The incidence of epidermal hyperplasia in 400 mg/mL in males and females was considered to be chemical-related. In the 14 weeks exposure study, the NOAEL for rats is 500 mg a.i./kg/day based on epidermal hyperplasia and the NOAEL for mice is 440 mg/kg bw. The NOAEL for local dermal effects was set considering also the two years carcinogenicity study on dermal application which was generally comparable to the OECD 453 guideline study. There were no treatment related incidences of mononuclear cell leukaemia, neoplasms, or non-neoplastic lesions of the skin and other organs. In that study the NOAEL for females is 60 mg a.i./kg/day based on epidermal hyperplasia. This value was then used for the NOAEL for local dermal effects. No systemic toxicity was observed in this or any of the other repeat dose dermal studies. The repeated dose toxicity for inhalation exposure does not to be investigated because exposure of humans via inhalation in production and/or use is not likely as based on the thorough and rigorous exposure assessment. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): Sufficient to meet requirements. The study with the lowest NOAEL for local effects (hyperplasia of the epidermis) is the 2 year dermal carcinogenicity study in the rat, where the NOAEL for females was 60 mg/kg. Taking a mean body weight figure for the female rats in the 60 mg/kg dose group of 0.2kg (stated range = 0.107 to 0.288 kg) and assuming a surface area of dosing of 25 cm2, gives a NOAEL of 0.48 mg/cm2. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Sufficient to meet requirements ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a364ddd-2674-449a-b6a2-57de4097d66f/documents/7120c543-749e-497c-91de-3dddeacaaa48_8639067f-2c2a-488b-a15c-ad591fabd589.html,,,,,, Sodium p-cumenesulphonate,15763-76-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a364ddd-2674-449a-b6a2-57de4097d66f/documents/7120c543-749e-497c-91de-3dddeacaaa48_8639067f-2c2a-488b-a15c-ad591fabd589.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,763 mg/kg bw/day,,rat Sodium p-cumenesulphonate,15763-76-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a364ddd-2674-449a-b6a2-57de4097d66f/documents/7120c543-749e-497c-91de-3dddeacaaa48_8639067f-2c2a-488b-a15c-ad591fabd589.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.48 mg/cm2,adverse effect observed,rat Sodium p-cumenesulphonate,15763-76-5,"The HYDROTOPES Category comprises the following 6 substances: STS - Sodium toluene 4-sulphonate (CAS 657-84-1, EC 211-522-5)SXS - Sodium (xylenes and 4-ethylbenzene) sulfonates (EC 701-037-1)NH4XS - Ammonium (xylenes and 4-ethylbenzene) sulfonates (EC 943-024-5)SCS - Sodium p-cumenesulphonate (CAS 15763-76-5, EC 239-854-6)KCS - Potassium p-cumenesulphonate (CAS 164524-02-1, EC 629-764-9)NH4CS - Ammonium p-cumenesulphonate (CAS 680972-33-2, EC 811-484-5)  In addition CaXS (Calcium Xylenesulphonate, CAS 28088-63-3, EC 248-829-9) was evaluated for complete the assessment despite it is not registered under REACH. The acute oral toxicity has been tested at least for each member of the hydrotropes subgroup (toluene, xylene and cumene). The LC50 values in rats ranging from 3000 to 16000 mg/Kg bw, depending on the tested dose. No deaths related to the test item occurred up to the highest tested doses for each available test. There is only one test for acute inhalation toxicity for NH4XS which did not show clinical effects following inhalation exposure. The acute dermal toxicity is available for xylene and cumene sulphonates with a LD50 values greater than 2000 mg/kg bw. The available data on the substances in the category show that they are all negative regarding acute toxicity. Across the hydrotropes category, toxicity results are consistent across the toluene, xylene and cumene sulfonates and their various salts. All results consistently indicate no evidence for oral, dermal and inhalation toxicity for Hydrotopes category members. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Sufficient to meet requirements, similar to OECD 401 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Sufficient to meet requirements Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Sufficient to meet requirements ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a364ddd-2674-449a-b6a2-57de4097d66f/documents/2e52c6da-396b-4124-9f94-eeda39665f00_8639067f-2c2a-488b-a15c-ad591fabd589.html,,,,,, Sodium p-cumenesulphonate,15763-76-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a364ddd-2674-449a-b6a2-57de4097d66f/documents/2e52c6da-396b-4124-9f94-eeda39665f00_8639067f-2c2a-488b-a15c-ad591fabd589.html,,oral,LD50,"3,346 mg/kg bw",adverse effect observed, Sodium p-cumenesulphonate,15763-76-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a364ddd-2674-449a-b6a2-57de4097d66f/documents/2e52c6da-396b-4124-9f94-eeda39665f00_8639067f-2c2a-488b-a15c-ad591fabd589.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium p-cumenesulphonate,15763-76-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a364ddd-2674-449a-b6a2-57de4097d66f/documents/2e52c6da-396b-4124-9f94-eeda39665f00_8639067f-2c2a-488b-a15c-ad591fabd589.html,,inhalation,LC50,"6,410 mg/m3",no adverse effect observed, Sodium perchlorate,7601-89-0,"Ammonium perchlorate was shown to have antithyroid effects, without any other repeat-dose toxic effects, in a Klimisch 2 GLP rat 90-day study at up to 10 mg/kg/day via drinking water. The overall NOAEL was 1 mg/kg/day. All antithyroid effects were demonstrated to be partly to completely reversible within 30 days.However, the antithyroid effects from a rat 2-generation study were considered to be more reliable for the classification and risk assessment related to repeated exposure, because of this study's higher sensitivity than the 90-day study (40% longer treatment duration: 113-142 days, more individual thyroid data per sex per dose: 56-60 vs. 9-10, 3-fold higher top-dose, presence of highly sensitive populations: pregnant dams and pups) and of the better biological relevance of the dose-relationship (dose-increase, vs. plateauing of effects in the 90-day study). This resulted in a lower NOAEL, reported below, of 0.3 mg/kg/day.The full RSS of the 2-generation study is under section 7.8.1. In this study conducted at up to 30 mg/kg/day, parental and offspring retained NOAELs for antithyroid effects were both 0.3 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/041a5653-3753-4e05-ab4b-bd40ffceb0d6/documents/IUC5-65c33f4a-34e5-403f-94c9-eb09774cae61_1c51e614-b258-472d-8239-aec29300880a.html,,,,,, Sodium perchlorate,7601-89-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/041a5653-3753-4e05-ab4b-bd40ffceb0d6/documents/IUC5-65c33f4a-34e5-403f-94c9-eb09774cae61_1c51e614-b258-472d-8239-aec29300880a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.3 mg/kg bw/day,,rat Sodium perchlorate,7601-89-0,sodium perchlorate was administered orally and dermally to rats according to OECD Guidelines 423 and 402 respectively. The LD0 of sodium perchlorate was found to be higher than 2000 mg/kg when administered via the oral or dermal route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/041a5653-3753-4e05-ab4b-bd40ffceb0d6/documents/IUC5-beb22b8a-5ea8-4148-9ce0-05af597626ba_1c51e614-b258-472d-8239-aec29300880a.html,,,,,, Sodium perchlorate,7601-89-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/041a5653-3753-4e05-ab4b-bd40ffceb0d6/documents/IUC5-beb22b8a-5ea8-4148-9ce0-05af597626ba_1c51e614-b258-472d-8239-aec29300880a.html,,oral,discriminating dose,"2,000 mg/kg bw",adverse effect observed, Sodium perchlorate,7601-89-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/041a5653-3753-4e05-ab4b-bd40ffceb0d6/documents/IUC5-beb22b8a-5ea8-4148-9ce0-05af597626ba_1c51e614-b258-472d-8239-aec29300880a.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Sodium periodate,7790-28-5," Oral The subchronic (90 day) oral NOAEL in rats (female) was determined to be 3 mg/kg bw/day (potassium iodate) Inhalation and Dermal In accordance with REACH Annex VIII, section 8.6.1, a short-term toxicity study does not need to be conducted if a reliable sub-chronic (90 days) study is available. The oral route is considered to be the most appropriate route of administration and this endpoint has been addressed by a sub-chronic toxicity study in which the test material was administered via the drinking water. it is therefore considered justified to omit sub-acute testing via the inhalation and dermal routes. In accordance with REACH Annex IX, section 8.6.2, a sub-chronic toxicity study (90 day), one species, rodent, male and female, most appropriate route of administration is required. The oral route is considered to be the most appropriate route of administration and data has therefore been provided to address this. As such, the registrant considers it justified to omit a sub-chronic toxicity study via the inhalation route. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/310870c7-4a00-4901-9fe6-230834a7e87e/documents/IUC5-e6206db3-42a7-4ad2-a271-84d665f6c881_f323bd3d-8b9e-4043-a5e9-3caf94a8fa68.html,,,,,, Sodium periodate,7790-28-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/310870c7-4a00-4901-9fe6-230834a7e87e/documents/IUC5-e6206db3-42a7-4ad2-a271-84d665f6c881_f323bd3d-8b9e-4043-a5e9-3caf94a8fa68.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,3 mg/kg bw/day,,rat Sodium periodate,7790-28-5," In accordance with Section 8.5, Column 2 of REACH Annex VII, acute toxicity testing is considered inappropriate as the substance has been determined to be corrosive to the skin in a study conducted to OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test) EU Method B.40 (Skin Corrosion). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/310870c7-4a00-4901-9fe6-230834a7e87e/documents/IUC5-3d96fb3d-5530-4ada-9f97-23e83518476a_f323bd3d-8b9e-4043-a5e9-3caf94a8fa68.html,,,,,, Sodium permanganate,10101-50-5,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyInformation.KeyInformation): Key Short-Term Repeated Dose Oral Toxicity in Rats: Read-Across Source MnSO4 – NTP (1993) The 14 day NOAEL was 25 000 ppm.   Supporting Short-Term Repeated Dose Oral Toxicity in Mice: Read-Across Source MnSO4 – NTP (1993) The 14 day NOAEL was considered to be 50 000 ppm.   Key Sub-Chronic Repeated Dose Oral Toxicity in Rats: Read-Across Source MnSO4 – NTP (1993) No NOAEL could be identified for male rats on the basis of liver weight differences. A NOAEL of 3 130 ppm for female rats can be assigned on the basis of reduced body weight gain at doses of 6 250 ppm and higher.   Supporting Sub-Chronic Repeated Dose Oral Toxicity in Mice: Read-Across Source MnSO4 – NTP (1993) No NOAEL could be identified for males on the basis of reduced body weight gain in all treated groups. The NOAEL for females can be considered to be 25 000 ppm, on the basis that body weight gain and haematology parameters were affected in the 50 000 ppm group.   Repeated Dose Inhalation Toxicity The substance is considered to be corrosive, therefore inhalation exposure must be minimised by the use of suitable engineering controls and/or PPE.  The repeated dose toxicity of the substance is adequately addressed by the results of a 28-day oral study.  Further testing by the inhalation route is not justified on scientific grounds as local effects will predominate, for reasons of exposure and additionally for reasons of animal welfare.   Repeated Dose Dermal Toxicity The substance is considered to be corrosive, therefore dermal exposure must be minimised by the use of suitable engineering controls and/or PPE. The repeated dose toxicity of the substance is adequately addressed by the results of a 28-day oral study. Further testing by the dermal route is not justified on scientific grounds as local effects will predominate, for reasons of exposure and additionally for reasons of animal welfare.Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Read across from a single read across substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d37f3cdf-e0df-4f4e-88be-995dbe2d860b/documents/IUC5-b6009cca-f99e-4649-ac57-f1d736a1677a_d654e913-828c-4449-a59b-1db58895e120.html,,,,,, Sodium permanganate,10101-50-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d37f3cdf-e0df-4f4e-88be-995dbe2d860b/documents/IUC5-b6009cca-f99e-4649-ac57-f1d736a1677a_d654e913-828c-4449-a59b-1db58895e120.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"25,000 mg/kg bw/day",,rat Sodium permanganate,10101-50-5,"Migrated Data from field(s)Field No-label (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyInformation.KeyInformation): In accordance with Column 2 of REACH Annex VII, information requirement section 8.5.1, 8.5.2 and 8.5.3 the acute toxicity studies by the oral, dermal and inhalation routes do not need to be conducted as the substance is classified as corrosive to the skin.  Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Single study on a read-across substance conducted according to a standardised guideline and in compliance with GLP. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d37f3cdf-e0df-4f4e-88be-995dbe2d860b/documents/IUC5-ef0fc4ac-2dc3-43bc-a6e9-4818cb3c2d5d_d654e913-828c-4449-a59b-1db58895e120.html,,,,,, Sodium phenylacetate,114-70-5," LD50 was estimated to be 2146.45mg/kg bw, when female wistar rats were exposed with Sodium phenylacetate (114-70-5) orally. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/692da8d3-0f03-4198-abbe-48882c06a6f4/documents/58b8e491-840b-467a-a8d7-4c0b7402bf94_ed6a8923-cf90-4820-a649-66ab8a8f5d1c.html,,,,,, Sodium phenylacetate,114-70-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/692da8d3-0f03-4198-abbe-48882c06a6f4/documents/58b8e491-840b-467a-a8d7-4c0b7402bf94_ed6a8923-cf90-4820-a649-66ab8a8f5d1c.html,,oral,LD50,"2,146.45 mg/kg bw",no adverse effect observed, Sodium selenate,13410-01-0," Several reliable short-term repeated dose and sub-chronic studies are availble for the oral route: Abdo (1994), NOAEL rat: 0.4 mg Se/kg bw/d (sub-chronic test with sodium selenite), NOAEL 0.4 mg Se/kg bw/d (sub-chronic test with sodium selenate) Abdo (1994), NOAEL mouse: 0.9 mg Se/kg bw/d (sub-chronic test with sodium selenite), NOAEL 0.8 mg Se/kg bw/d (sub-chronic test with sodium selenate) Bioulac (1992), NOAEL rat: 0.12 mg Se/kg bw/d (test with sodium selenite) Johnson (2000), NOAEL mouse: 0.36 mg Se/kg bw/d (test with sodium selenite) Based on these data, a NOAEL for rats of 0.4 mg Se/ kg bw/day has been selected as the key value for repeated dose toxicity via the oral route. No studies on repeated dose toxicity via inhalation or dermal route are available. Yang et al. (1989): NOAEL man: Se-intake of 850 µg Se/day per person; this figure is used as starting point for DNEL derivation (see chapter 5.11. of CSR). It has to be emphasized, that the NOAEL according to Yang et al. (1989), which is used as starting point for DNEL derivation is based on human data. The existing studies on humans are considering a wealth of toxicological endpoints and overrule the available animal by far. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf643ccd-8c1d-4bae-9655-8fad0ac1f10f/documents/7fc7643d-413d-4116-8646-33c571a35217_be1bca9c-fe3c-46b5-9ff3-e5450751b70e.html,,,,,, Sodium selenate,13410-01-0," Acute oral toxicity: LD50: 7 mg sodium selenite /kg bw for rats dosed with sodium selenite by gavage. Acute inhalation toxicity: LC50 (4 h) > 0.052 and ≤ 0.51 mg sodium selenate /L, for Wistar rats exposed to sodium selenate, according to OECD 403 (Acute inhalation toxicity), GLP compliant ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf643ccd-8c1d-4bae-9655-8fad0ac1f10f/documents/bc201993-a333-4bb6-91b3-9196f7563d03_be1bca9c-fe3c-46b5-9ff3-e5450751b70e.html,,,,,, Sodium selenate,13410-01-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf643ccd-8c1d-4bae-9655-8fad0ac1f10f/documents/bc201993-a333-4bb6-91b3-9196f7563d03_be1bca9c-fe3c-46b5-9ff3-e5450751b70e.html,,oral,LD50,7 mg/kg bw,adverse effect observed, Sodium selenate,13410-01-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf643ccd-8c1d-4bae-9655-8fad0ac1f10f/documents/bc201993-a333-4bb6-91b3-9196f7563d03_be1bca9c-fe3c-46b5-9ff3-e5450751b70e.html,,inhalation,LC50,52 mg/m3,adverse effect observed, Sodium sulfide (Na2(Sx)),1344-08-7," In the key study, the 90-day inhalation toxicity study with exposure of rats and mice to hydrogen sulfide (Dorman et al., 2004), no toxicologically relevant alterations in haematological indices, serum chemistries, or gross pathology. Therefore, the highest concentration of 80 ppm H2S may be considered as NOAEC for systemic effects. When comparing the results of the available sub-chronic studies in rats and mice, it becomes obvious that the findings of these inhalation studies are not contradictory. Brennemann et al. (2000), Moulin et al. (2002) and Dorman et al. (2004) found similar targets of toxicity. The main adverse effect caused by 30 and 80 ppm hydrogen sulfide was an exposure-related increased incidence of olfactory neuronal loss (ONL). Thus, the concentration of 10 ppm H2S represents an NOAEC for local effects in the olfactory system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/efe21c22-f764-4887-9905-d389c88eecea/documents/IUC5-435ee8e0-820f-45bc-9c40-3f02a5ec22d3_ac71adb3-f1e6-4b50-ac27-130bd93de60e.html,,,,,, Sodium sulfide (Na2(Sx)),1344-08-7,The oral LD50 for Na2Sx is 85.8 (95% CI 73.8 - 99.6) mg/kg bw.The dermal LD50 Na2Sx is 590 mg/kg bw.An inhalation study was not performed and an LD50 is not available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efe21c22-f764-4887-9905-d389c88eecea/documents/IUC5-80d7cdd7-2bb6-49e9-9638-4958e7fbeef0_ac71adb3-f1e6-4b50-ac27-130bd93de60e.html,,,,,, Sodium sulfide (Na2(Sx)),1344-08-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efe21c22-f764-4887-9905-d389c88eecea/documents/IUC5-80d7cdd7-2bb6-49e9-9638-4958e7fbeef0_ac71adb3-f1e6-4b50-ac27-130bd93de60e.html,,oral,LD50,85.8 mg/kg bw,, Sodium sulfide (Na2(Sx)),1344-08-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/efe21c22-f764-4887-9905-d389c88eecea/documents/IUC5-80d7cdd7-2bb6-49e9-9638-4958e7fbeef0_ac71adb3-f1e6-4b50-ac27-130bd93de60e.html,,dermal,LD50,590 mg/kg bw,, Sodium sulphamidate,13845-18-6,"The oral administration of Sodium sulphamate to rats by gavage, at dose levels of 100, 300 and 1000 mg/kg bw/day, did not result in any toxicologically significant effects. The ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was therefore considered to be 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b060b94-d59d-4fbf-b2ea-776678dd7302/documents/IUC5-70cbbca1-78c5-4ac9-8e36-2594cfcffe26_8001f319-0806-4fa4-a49e-84bd54fc12c2.html,,,,,, Sodium sulphamidate,13845-18-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4b060b94-d59d-4fbf-b2ea-776678dd7302/documents/IUC5-70cbbca1-78c5-4ac9-8e36-2594cfcffe26_8001f319-0806-4fa4-a49e-84bd54fc12c2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sodium sulphamidate,13845-18-6,Acute oral toxicity: The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg bodyweight Acute dermal toxicity: The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b060b94-d59d-4fbf-b2ea-776678dd7302/documents/IUC5-76f6af8e-2fc6-407f-9b18-3255b4072d31_8001f319-0806-4fa4-a49e-84bd54fc12c2.html,,,,,, Sodium sulphamidate,13845-18-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b060b94-d59d-4fbf-b2ea-776678dd7302/documents/IUC5-76f6af8e-2fc6-407f-9b18-3255b4072d31_8001f319-0806-4fa4-a49e-84bd54fc12c2.html,,oral,LD50,"2,500 mg/kg bw",, Sodium sulphamidate,13845-18-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4b060b94-d59d-4fbf-b2ea-776678dd7302/documents/IUC5-76f6af8e-2fc6-407f-9b18-3255b4072d31_8001f319-0806-4fa4-a49e-84bd54fc12c2.html,,dermal,LD50,"2,000 mg/kg bw",, Sodium tetrafluoroborate,13755-29-8, A NOAEL of 40 mg/kg bw/day was established in a reproduction/developmental toxicity screening test and a NOAEL of 226 mg/m3 was established in a 90-day inhalation study in rats for systemic effects. No local effect were observed at concentrations up to 225 mg/m3 in the 90-day inhalation study. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/342c7694-ff15-403d-a5d7-34c57db79871/documents/8440188c-7f57-4167-a6cb-0a70f29b249c_d70df748-2569-4439-84ef-37804b421714.html,,,,,, Sodium tetrafluoroborate,13755-29-8, A LD50 greater than 2000 mg NaBF4/kg bw (equivalent to 2294 mg KBF4) was observed in the acute oral toxicity study and a LD50 of 5300 mg KBF4/m3 bw was observed in the inhalation toxicity study. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/342c7694-ff15-403d-a5d7-34c57db79871/documents/bd04f6f3-b14b-4c36-b5b7-5fe2f1a27e95_d70df748-2569-4439-84ef-37804b421714.html,,,,,, Sodium tetrafluoroborate,13755-29-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/342c7694-ff15-403d-a5d7-34c57db79871/documents/bd04f6f3-b14b-4c36-b5b7-5fe2f1a27e95_d70df748-2569-4439-84ef-37804b421714.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Sodium tetrafluoroborate,13755-29-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/342c7694-ff15-403d-a5d7-34c57db79871/documents/bd04f6f3-b14b-4c36-b5b7-5fe2f1a27e95_d70df748-2569-4439-84ef-37804b421714.html,,inhalation,LC50,"5,300 mg/m3",no adverse effect observed, sodium;2-chloroprop-2-enoate;hydrate,32997-86-7, Based on the results of this study it is concluded that the LD50 of the test item is 300 < LD50 < 2000 mg/kg bw when administered as a single dose by oral gavage to female Sprague Dawley rats according to OECD 423. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a809359-56e5-49bc-bad0-3822136b7ee1/documents/218c79c5-aebe-4a30-a09a-cf93f391c729_73ede8d1-c90c-4ac5-8a13-8f8626adae43.html,,,,,, Solsperse 22000-Wirksubstanz,86753-82-4," The test substance was administered daily for at least 90 days by oral gavage to SPF-bred Wistar rats. One control group and three treated groups were used. each consisting of 10 males and 10 females. The following parameters were evaluated: Clinical signs, functional observations, body weight, food consumption and opthalmoscopy. Urine and faeces samples were collected in week 13. At termination: clinical pathology, macroscopy and organ weights. Histopathology was performed on a selection of tissues. Since the findings in the adrenal cortex were also seen in one of the control females, the histiocytosis in the mesenteric lymph nodes was not accompanied by adverse tissue reaction and the post dosing salivation considered due to the bad taste of the substance, a No Observed Adverse Effect Level (NOAEL) of 200 mg/kg/day may be considered for males and females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a0b8dda-7e51-4fd5-8330-0b868f265ec1/documents/3607631b-2b17-4652-9f5d-7d8579aec38c_331bcb5a-42bb-45a6-90b4-4914a7c8f72a.html,,,,,, Solsperse 22000-Wirksubstanz,86753-82-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5a0b8dda-7e51-4fd5-8330-0b868f265ec1/documents/3607631b-2b17-4652-9f5d-7d8579aec38c_331bcb5a-42bb-45a6-90b4-4914a7c8f72a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Solsperse 22000-Wirksubstanz,86753-82-4," In oral acute toxicity studies an LD50 of > 2000 mg/kg was determined in rats. Dermal toxicity after single dermal application was tested in male and female rats. The LD50 value for acute dermal toxicity is >2,000 mg/kg bw. Acute inhalation toxicity: Study was waived ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a0b8dda-7e51-4fd5-8330-0b868f265ec1/documents/b6721741-c6c9-4ec4-bb57-146ea637be4a_331bcb5a-42bb-45a6-90b4-4914a7c8f72a.html,,,,,, Solsperse 22000-Wirksubstanz,86753-82-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a0b8dda-7e51-4fd5-8330-0b868f265ec1/documents/b6721741-c6c9-4ec4-bb57-146ea637be4a_331bcb5a-42bb-45a6-90b4-4914a7c8f72a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Solsperse 22000-Wirksubstanz,86753-82-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a0b8dda-7e51-4fd5-8330-0b868f265ec1/documents/b6721741-c6c9-4ec4-bb57-146ea637be4a_331bcb5a-42bb-45a6-90b4-4914a7c8f72a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Solvent naphtha (petroleum), heavy aliph.",64742-96-7,"A number of subacute and subchronic studies with kerosines and jet fuels are available (OECD 410, 412, 413, and other non-guideline protocols). The repeated inhalation and oral studies of kerosine in rats produced no consistent toxicological effects other than changes in male rat kidneys that are not considered relevant to humans. The NOAEC for inhalation exposure is greater than or equal to 1000 mg/m3 (vapour).  The systemic dermal NOAEL is greater than or equal to 495 mg/kg bw/day, based on a well conducted 90-day study in rats.  The NOAEL for systemic effects of oral exposure is 750 mg/kg/day. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/30448664-41af-4589-9f4e-0b579fe6bf2a/documents/89277e09-fd6a-4778-85aa-41521a1ff043_6c53b6a6-c6ae-4f95-8121-93e08ec43932.html,,,,,, "Solvent naphtha (petroleum), heavy aliph.",64742-96-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/30448664-41af-4589-9f4e-0b579fe6bf2a/documents/89277e09-fd6a-4778-85aa-41521a1ff043_6c53b6a6-c6ae-4f95-8121-93e08ec43932.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Solvent naphtha (petroleum), heavy aliph.",64742-96-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/30448664-41af-4589-9f4e-0b579fe6bf2a/documents/89277e09-fd6a-4778-85aa-41521a1ff043_6c53b6a6-c6ae-4f95-8121-93e08ec43932.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,495 mg/kg bw/day,,rat "Solvent naphtha (petroleum), heavy aliph.",64742-96-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/30448664-41af-4589-9f4e-0b579fe6bf2a/documents/89277e09-fd6a-4778-85aa-41521a1ff043_6c53b6a6-c6ae-4f95-8121-93e08ec43932.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat "Solvent naphtha (petroleum), heavy aliph.",64742-96-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/30448664-41af-4589-9f4e-0b579fe6bf2a/documents/89277e09-fd6a-4778-85aa-41521a1ff043_6c53b6a6-c6ae-4f95-8121-93e08ec43932.html,Repeated dose toxicity – local effects,dermal,LOAEL,1 mg/cm2,adverse effect observed,rat "Solvent naphtha (petroleum), heavy aliph.",64742-96-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/30448664-41af-4589-9f4e-0b579fe6bf2a/documents/89277e09-fd6a-4778-85aa-41521a1ff043_6c53b6a6-c6ae-4f95-8121-93e08ec43932.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,000 mg/m3",no adverse effect observed,rat "Solvent naphtha (petroleum), heavy aliph.",64742-96-7,"Kerosines are of low acute toxicity with mortality rarely reported even at very high exposures in experimental animal studies conducted by oral (similar to OECD 420), dermal (similar to OECD 402), and inhalation (similar to OECD 403) exposure.  • The oral LD50 was > 5000 mg/kg bw in male and female rats for kerosine.• The dermal LD50 was > 2000 mg/kg/bw in male and female rabbits for kerosine.• The inhalation LC50 was > 5.28 mg/L vapour in male and female rats for kerosine. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30448664-41af-4589-9f4e-0b579fe6bf2a/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_6c53b6a6-c6ae-4f95-8121-93e08ec43932.html,,,,,, "Solvent naphtha (petroleum), heavy aliph.",64742-96-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30448664-41af-4589-9f4e-0b579fe6bf2a/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_6c53b6a6-c6ae-4f95-8121-93e08ec43932.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Solvent naphtha (petroleum), heavy aliph.",64742-96-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30448664-41af-4589-9f4e-0b579fe6bf2a/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_6c53b6a6-c6ae-4f95-8121-93e08ec43932.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Solvent naphtha (petroleum), heavy aliph.",64742-96-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/30448664-41af-4589-9f4e-0b579fe6bf2a/documents/d7c5ec3b-ae11-4e1d-b7f4-4bdb793f5127_6c53b6a6-c6ae-4f95-8121-93e08ec43932.html,,inhalation,LC50,"5,280 mg/m3",no adverse effect observed, "Solvent naphtha (petroleum), medium aliph.",64742-88-7,"A number of subacute and subchronic studies with kerosines and jet fuels are available (OECD 410, 412, 413, and other non-guideline protocols). The repeated inhalation and oral studies of kerosine in rats produced no consistent toxicological effects other than changes in male rat kidneys that are not considered relevant to humans. The NOAEC for inhalation exposure is greater than or equal to 1000 mg/m3 (vapour). The systemic dermal NOAEL is greater than or equal to 0.5 mL/kg/day (400 mg/kg bw/day). The NOAEL for systemic effects of oral exposure is 750 mg/kg/day. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/df08d82f-eff1-4bca-b25a-4e9c7b0968dc/documents/IUC5-d66068e9-a4f6-4acf-88c0-ef9af33b4423_a443cfb5-e57e-4007-b252-f8ab3b06696a.html,,,,,, "Solvent naphtha (petroleum), medium aliph.",64742-88-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/df08d82f-eff1-4bca-b25a-4e9c7b0968dc/documents/IUC5-d66068e9-a4f6-4acf-88c0-ef9af33b4423_a443cfb5-e57e-4007-b252-f8ab3b06696a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,, "Solvent naphtha (petroleum), medium aliph.",64742-88-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/df08d82f-eff1-4bca-b25a-4e9c7b0968dc/documents/IUC5-d66068e9-a4f6-4acf-88c0-ef9af33b4423_a443cfb5-e57e-4007-b252-f8ab3b06696a.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,, "Solvent naphtha (petroleum), medium aliph.",64742-88-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/df08d82f-eff1-4bca-b25a-4e9c7b0968dc/documents/IUC5-d66068e9-a4f6-4acf-88c0-ef9af33b4423_a443cfb5-e57e-4007-b252-f8ab3b06696a.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",, "Solvent naphtha (petroleum), medium aliph.",64742-88-7,"Kerosine is of low acute toxicity with mortality rarely reported at very high exposures in experimental animal studies conducted by oral (similar to OECD 420), dermal (similar to OECD 402), and inhalation (similar to OECD 403) exposure. • The oral LD50 was > 5000 mg/kg bw in male and female rats for kerosine.• The dermal LD50 was > 2000 mg/kg/bw in male and female rabbits for kerosine.• The inhalation LC50 was > 5.28 mg/L vapour in male and female rats for kerosine. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df08d82f-eff1-4bca-b25a-4e9c7b0968dc/documents/IUC5-12559971-8404-41f5-ad3d-eb344b598168_a443cfb5-e57e-4007-b252-f8ab3b06696a.html,,,,,, "Solvent naphtha (petroleum), medium aliph.",64742-88-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df08d82f-eff1-4bca-b25a-4e9c7b0968dc/documents/IUC5-12559971-8404-41f5-ad3d-eb344b598168_a443cfb5-e57e-4007-b252-f8ab3b06696a.html,,oral,LD50,"5,000 mg/kg bw",, "Solvent naphtha (petroleum), medium aliph.",64742-88-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df08d82f-eff1-4bca-b25a-4e9c7b0968dc/documents/IUC5-12559971-8404-41f5-ad3d-eb344b598168_a443cfb5-e57e-4007-b252-f8ab3b06696a.html,,dermal,LD50,"2,000 mg/kg bw",, "Solvent naphtha (petroleum), medium aliph.",64742-88-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/df08d82f-eff1-4bca-b25a-4e9c7b0968dc/documents/IUC5-12559971-8404-41f5-ad3d-eb344b598168_a443cfb5-e57e-4007-b252-f8ab3b06696a.html,,inhalation,LC50,"5,280 mg/m3",, "Sorbitan, tridocosanoate",93980-59-7," Oral repeated dose toxicity, subacute (OECD 422, rat, m/f): NOAEL systemic = 1000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98382490-70c9-4710-84ca-513f4376df91/documents/c0fdd2c7-e6cb-4a82-b75a-2d50858ac3ea_8815060c-5d38-4981-b0db-0d01162bc007.html,,,,,, "Sorbitan, tridocosanoate",93980-59-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98382490-70c9-4710-84ca-513f4376df91/documents/c0fdd2c7-e6cb-4a82-b75a-2d50858ac3ea_8815060c-5d38-4981-b0db-0d01162bc007.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Sorbitan, tridocosanoate",93980-59-7," Acute oral toxicity (OECD 423, rat, f): LD50 > 2000 mg/kg bw Acute inhalation toxicity: No study required as the inhalation route of exposure is considered less relevant than the dermal route.   Acute dermal toxicity: According to the REACH Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2, no study is required. Sorbitan tridocosanoate (CAS 9380-59-7) does not meet the criteria for classification for acute toxicity or Specific Target Organ Toxicity after Single Exposure (STOT SE) by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin sensitisation).   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98382490-70c9-4710-84ca-513f4376df91/documents/91a1e04e-01f1-43c0-a5cf-c756488ceb5f_8815060c-5d38-4981-b0db-0d01162bc007.html,,,,,, "Sorbitan, tridocosanoate",93980-59-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98382490-70c9-4710-84ca-513f4376df91/documents/91a1e04e-01f1-43c0-a5cf-c756488ceb5f_8815060c-5d38-4981-b0db-0d01162bc007.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Soybean meal, protein extn. residue",91081-84-4," Acute Oral Toxicity Under the conditions of this study, the oral LD50 value in female Wistar rats was > 2 000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb1ea9b9-da20-47a3-b6ed-04dfed63198d/documents/02bfc60e-9bf3-42ae-8318-5d21965ba2a5_d17bcf6f-18bc-4c50-8bc8-8c0fd041801c.html,,,,,, "Soybean meal, protein extn. residue",91081-84-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eb1ea9b9-da20-47a3-b6ed-04dfed63198d/documents/02bfc60e-9bf3-42ae-8318-5d21965ba2a5_d17bcf6f-18bc-4c50-8bc8-8c0fd041801c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Soybean oil, deodorizer distillate",68783-88-0,"Oral NOAEL for risk assessment purposes: 19% in feed, equivalent to an estimated 9,250 mg/kg bw/day for fatty acids and gylcerides and ADI 0.15- 2.0 mg/kd/day for unsaponifiable matter. The dermal toxicology is based on the oral NOAEL.No significant respiratory exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a6f848f-d518-4766-9539-9f7d3ff400af/documents/IUC5-eb8ba241-8fd6-463c-8c51-633af82dc9d6_0cdd1138-6571-43d2-bba6-677d2f9c893a.html,,,,,, "Soybean oil, deodorizer distillate",68783-88-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a6f848f-d518-4766-9539-9f7d3ff400af/documents/IUC5-eb8ba241-8fd6-463c-8c51-633af82dc9d6_0cdd1138-6571-43d2-bba6-677d2f9c893a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"9,250 mg/kg bw/day",,rat "Soybean oil, deodorizer distillate",68783-88-0,Low acute toxicity after oral and dermal exposure ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a6f848f-d518-4766-9539-9f7d3ff400af/documents/IUC5-58b2c073-9af0-457d-bf39-e6f6fada4b01_0cdd1138-6571-43d2-bba6-677d2f9c893a.html,,,,,, "Soybean oil, deodorizer distillate",68783-88-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a6f848f-d518-4766-9539-9f7d3ff400af/documents/IUC5-58b2c073-9af0-457d-bf39-e6f6fada4b01_0cdd1138-6571-43d2-bba6-677d2f9c893a.html,,oral,LD50,"2,000 mg/kg bw",, "Soybean oil, deodorizer distillate",68783-88-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a6f848f-d518-4766-9539-9f7d3ff400af/documents/IUC5-58b2c073-9af0-457d-bf39-e6f6fada4b01_0cdd1138-6571-43d2-bba6-677d2f9c893a.html,,dermal,LD50,"2,000 mg/kg bw",, "Soybean oil, epoxidized, acrylate",91722-14-4,No effects were observed with the test substance up to 1000 mg/kg bw (the highest dose level used) in a repeated dose toxicity/screening reprotoxicity study according to OECD guideline No. 422. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3b4fc2b-cccb-4ce7-8de9-fd300e14205b/documents/IUC5-cb8c343d-285c-459a-8338-f16da31dc1e5_7fd12675-bc10-4f30-9a42-35ba2d59a495.html,,,,,, "Soybean oil, epoxidized, acrylate",91722-14-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3b4fc2b-cccb-4ce7-8de9-fd300e14205b/documents/IUC5-cb8c343d-285c-459a-8338-f16da31dc1e5_7fd12675-bc10-4f30-9a42-35ba2d59a495.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Soybean oil, epoxidized, acrylate",91722-14-4,"The test subtance is not acutely toxic for the oral and dermal route. In both studies, the LD50 is >2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3b4fc2b-cccb-4ce7-8de9-fd300e14205b/documents/IUC5-25908da1-3ad9-4904-be9b-f7dd5c24e402_7fd12675-bc10-4f30-9a42-35ba2d59a495.html,,,,,, "Soybean oil, epoxidized, acrylate",91722-14-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3b4fc2b-cccb-4ce7-8de9-fd300e14205b/documents/IUC5-25908da1-3ad9-4904-be9b-f7dd5c24e402_7fd12675-bc10-4f30-9a42-35ba2d59a495.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Soybean oil, epoxidized, acrylate",91722-14-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3b4fc2b-cccb-4ce7-8de9-fd300e14205b/documents/IUC5-25908da1-3ad9-4904-be9b-f7dd5c24e402_7fd12675-bc10-4f30-9a42-35ba2d59a495.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Soybean oil, epoxidized, ether with ethylene glycol",85586-34-1,A modern guideline-compliant screening oral study with the read-across substance ETP is available. Older one-year dietary studies in the rat and dog with the read-across substance ESBO are also available. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ced10267-7a1e-4609-8ffd-2dd93b4f0280/documents/IUC5-0cb77c80-5766-4831-b4f5-051e2c02ae58_d5040f0a-9d12-4792-b60e-475b6da04458.html,,,,,, "Soybean oil, epoxidized, ether with ethylene glycol",85586-34-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ced10267-7a1e-4609-8ffd-2dd93b4f0280/documents/IUC5-0cb77c80-5766-4831-b4f5-051e2c02ae58_d5040f0a-9d12-4792-b60e-475b6da04458.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Soybean oil, epoxidized, ether with ethylene glycol",85586-34-1,A modern acute oral toxicity study performed with the submission substance is supported by an older study with the read-across substance ESBO Dermal toxicity data are available for ESBO. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ced10267-7a1e-4609-8ffd-2dd93b4f0280/documents/IUC5-e1664a3f-9061-48e7-853b-990586ae0ed4_d5040f0a-9d12-4792-b60e-475b6da04458.html,,,,,, "Soybean oil, epoxidized, ether with ethylene glycol",85586-34-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ced10267-7a1e-4609-8ffd-2dd93b4f0280/documents/IUC5-e1664a3f-9061-48e7-853b-990586ae0ed4_d5040f0a-9d12-4792-b60e-475b6da04458.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Soybean oil, epoxidized, ether with ethylene glycol",85586-34-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ced10267-7a1e-4609-8ffd-2dd93b4f0280/documents/IUC5-e1664a3f-9061-48e7-853b-990586ae0ed4_d5040f0a-9d12-4792-b60e-475b6da04458.html,,dermal,LD50,"20,000 mg/kg bw",no adverse effect observed, "Soybean oil, epoxidized, Me ester, reaction products with propylene glycol",96690-51-6,"Repeated dose toxicity (OECD TG 407): NOAEL 1000 mg/kg bw/day in males and females. (limit dose) (read across from Fatty acids, C16-C18 and C18-unsatd., ME esters, epoxidized ) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66a25dc9-996d-4da0-b435-39bb5dcb65d9/documents/12cf4f9e-6a73-4fa1-98c5-c6773f8f73c5_e020f177-68a9-42c3-b6d3-29ebc12173f5.html,,,,,, "Soybean oil, epoxidized, Me ester, reaction products with propylene glycol",96690-51-6,Acute toxicity (oral): LD50 > 30.0 mL/kg bw (corresponds to > 29.52 g/kg bw) Acute toxicity (dermal): LD50 > 9.0 mL/kg bw (corresponds to > 8.856 g/kg bw) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66a25dc9-996d-4da0-b435-39bb5dcb65d9/documents/7ba9fd83-3e8b-4adc-9219-880f32a1f639_e020f177-68a9-42c3-b6d3-29ebc12173f5.html,,,,,, "Soybean oil, epoxidized, reaction products with methanol",85586-35-2,"Key: NOAEL = 1000 mg/kg bw/d, rat, oral (gavage), 90 days (subchronic), OECD 408, GLP, K1, 2022 Sup: NOAEL (male rats) = 300 mg/kg bw/d based on changes of body weight parameters, NOAEL (female rats) = 1000 mg/kg bw/d, rat, oral (gavage), 28-63 days (subacute), OECD 422, GLP, K1, 2022 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f859cf2-43f2-413c-ab1c-cc3f33473689/documents/daeaddfd-f2c0-4b67-890f-296a4f34901f_cc85eb0d-9ee0-475b-8c4c-02d45ccdc3e8.html,,,,,, "Soybean oil, epoxidized, reaction products with methanol",85586-35-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f859cf2-43f2-413c-ab1c-cc3f33473689/documents/daeaddfd-f2c0-4b67-890f-296a4f34901f_cc85eb0d-9ee0-475b-8c4c-02d45ccdc3e8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Soybean oil, epoxidized, reaction products with methanol",85586-35-2,"Acute oral toxicity Key: LD50 > 2000 mg/kg bw, no mortality observed, rat, no guideline, non-GLP, K2, 1983   Acute dermal toxicity Key: LD50 > 5000 mg/kg bw, no mortality observed, OECD 402, GLP, K1, 2013 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f859cf2-43f2-413c-ab1c-cc3f33473689/documents/3e6fac57-f5f7-4e80-9046-a265bb743381_cc85eb0d-9ee0-475b-8c4c-02d45ccdc3e8.html,,,,,, "Soybean oil, epoxidized, reaction products with methanol",85586-35-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f859cf2-43f2-413c-ab1c-cc3f33473689/documents/3e6fac57-f5f7-4e80-9046-a265bb743381_cc85eb0d-9ee0-475b-8c4c-02d45ccdc3e8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Soybean oil, epoxidized, reaction products with methanol",85586-35-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f859cf2-43f2-413c-ab1c-cc3f33473689/documents/3e6fac57-f5f7-4e80-9046-a265bb743381_cc85eb0d-9ee0-475b-8c4c-02d45ccdc3e8.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Soybean oil, maleated, ester with triethanolamine",85029-82-9," 1000 mg/kg/day, the highest dose level evaluated, was considered the no-observed-adverse-effect level (NOAEL) for the test item in male and female rats and for F1offspring growth (PND 0 to 13). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2f6c57c-278b-4635-a8f6-2a106f73bb2e/documents/c751db80-c2bb-4f4d-b5c5-23f1758bbd75_2f36d5f3-2461-4bad-921f-16d7311a6711.html,,,,,, "Soybean oil, maleated, ester with triethanolamine",85029-82-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2f6c57c-278b-4635-a8f6-2a106f73bb2e/documents/c751db80-c2bb-4f4d-b5c5-23f1758bbd75_2f36d5f3-2461-4bad-921f-16d7311a6711.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Soybean oil, maleated, ester with triethanolamine",85029-82-9," A study was performed to OECD Guideline for Testing of Chemicals 402 (Acute Dermal Toxicity) and in conclusion the acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight. A study was performed to OECD Guideline for Testing of Chemicals No 420 ""Acute Oral Toxicity - Fixed Dose Method"" (2001) & in conclusion the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was found to be greater than 2000 mg/kg body weight. Inhalation: REACH Annex VIII, Section 8.5, Column 2, states that information on acute toxicity will be provided for the oral route plus at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. As a result, it is considered that inhalation exposure will be low and the most likely route of exposure for workers and consumers is the dermal route. Testing for acute toxicity via the inhalation route is consequently not applicable. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2f6c57c-278b-4635-a8f6-2a106f73bb2e/documents/1e6fcb6a-1e43-4019-a577-c8e337238006_2f36d5f3-2461-4bad-921f-16d7311a6711.html,,,,,, "Soybean oil, maleated, ester with triethanolamine",85029-82-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2f6c57c-278b-4635-a8f6-2a106f73bb2e/documents/1e6fcb6a-1e43-4019-a577-c8e337238006_2f36d5f3-2461-4bad-921f-16d7311a6711.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Soybean oil, maleated, ester with triethanolamine",85029-82-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2f6c57c-278b-4635-a8f6-2a106f73bb2e/documents/1e6fcb6a-1e43-4019-a577-c8e337238006_2f36d5f3-2461-4bad-921f-16d7311a6711.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Speiss, copper",69029-97-6,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d4bc8ef8-7901-480b-9c90-c5cf3ce8c7c4/documents/d0a2ede7-1c60-471e-89da-7681e39401fd_4a2321e2-2b36-4733-b330-36bd08e5a7db.html,,,,,, "Speiss, copper",69029-97-6,The acute toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d4bc8ef8-7901-480b-9c90-c5cf3ce8c7c4/documents/603e2ea6-336d-49e8-a7a8-a1d4e960ad45_4a2321e2-2b36-4733-b330-36bd08e5a7db.html,,,,,, "Speiss, lead",84195-61-9, Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. At least one component has reliable and good quality evidence from human cases or epidemiological studies or animal studies with significant and/or severe toxic effects at low oral/inhalation exposure concentrations. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bddea9c5-653e-4418-a8b1-7499af5d8eb1/documents/IUC5-44d3ed88-5562-4ec4-908f-ed3687cf14de_36c6f041-c9e1-47e5-a985-714cd06bde0e.html,,,,,, "Speiss, lead",84195-61-9, The acute toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bddea9c5-653e-4418-a8b1-7499af5d8eb1/documents/IUC5-b14b3628-3156-4e17-a73c-715c5a046689_36c6f041-c9e1-47e5-a985-714cd06bde0e.html,,,,,, "Speiss, lead, nickel-contg.",98246-91-4,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4a85ad7a-e71d-4d1b-a83f-c65272046228/documents/IUC5-154b867c-a785-4cde-b29e-b76194b047e5_959b861b-7a03-4b24-b374-c6cc759252a3.html,,,,,, "Speiss, lead, nickel-contg.",98246-91-4,The acute toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4a85ad7a-e71d-4d1b-a83f-c65272046228/documents/IUC5-5d73aec1-02bd-4025-8008-69301f9223dd_959b861b-7a03-4b24-b374-c6cc759252a3.html,,,,,, "Spinels, chromium iron manganese brown",68555-06-6,"Sub-acute oral toxicity 28 -day repeated dose toxicity studies were conducted in rats as a limit test to assess the effect of the analogue pigments chromium iron oxide and manganese alumina pink corundum on rats following repeated oral administration. The studies were performed according to OECD test guideline 407 and in compliance with GLP. No signs of toxicity were observed in rats when administered at a dose of 1000 mg/kg bw/day for up to 28 days. Consequently, the no observed adverse effect level (NOAEL) in rats is 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9f256cfd-f897-4127-adac-7c4ab3f11a72/documents/IUC5-9b8dc085-0689-43e7-af0b-8ab3887ee7fb_8f111da7-b540-4d3e-8c76-aa16d34f3463.html,,,,,, "Spinels, chromium iron manganese brown",68555-06-6,"Acute oral toxicity: LD50 > 5000 mg/kg bw (OECD 423 (2001); GLP- compliant; female rats) Acute inhalation toxicity: LC50 (rats; 4 hours) > 5.07 mg/L air (actual concentration) (OECD 436 (2009); GLP compliant) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study fulfils the rquirements for acute oral toxicity under REACH (Regulation (EC) 1907/2006). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The study fulfils the requirements for acute inhalation toxicity under REACH (Regulation (EC) 1907/2006). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9f256cfd-f897-4127-adac-7c4ab3f11a72/documents/IUC5-d71a0c70-9dab-4117-bfd2-0c7578464deb_8f111da7-b540-4d3e-8c76-aa16d34f3463.html,,,,,, "5-Hydroxy-6 beta,7 beta;15 beta,16 beta-dimethylene-3-oxo-5 beta,17 alpha-pregnane-21,17-carbolactone",197721-70-3,"Oral: (Rat-Wistar, GLP, OECD TG 423): LD50 > 2000 mg/kg[Schering AG, Report No. B060; 1999-02-22]Dermal (Rat-Wistar, GLP, OEDD TG 402 & 404): LD50 > 2000 mg/kg[Nihon Schering KK, Report No A11512, 2004-06-18] ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f87fbee-66f0-4567-bf06-e692fa0c2fac/documents/IUC5-55132dc2-041b-42e2-8c25-40b8d45c7086_56e78172-d5b4-498b-8cbd-4bd67cb3943c.html,,,,,, "5-Cyano-11 alpha-hydroxy-3,5'-dioxo-4 beta,5',6,7 beta-tetrahydrocyclopenta[4,5,6,7]-5 beta,17 alpha-pregnane-21,17-carbolactone",192704-54-4,"Oral (Rat, OECD TG 423): LD50 > 2000 mg/kg[Schering AG, Report No. X549 -draft-, 2001-03-26]Dermal (Rat, OECD TG 402): LD50 > 2000 mg/kg[Schering AG, Report No. X525 -draft-, 2001-02-08] ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0e541f2-432d-4bb9-9c25-df0ddb27d788/documents/IUC5-8e601381-1f21-4881-b759-40943f72d2aa_5afbd4ef-8237-4c4c-a6c8-c64f6de2c524.html,,,,,, "Spiro[piperidine-1,1'-pyrrolidinium] bifluoride",1803551-73-6,No acute toxicity studies were conducted since the substance is classified as corrosive to the skin (Cat 1A) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f4c07d88-16f5-40ef-a01a-c9a5625fe473/documents/fb16e343-80ee-426e-8e7c-fac1b4e7aa4e_ffaa877f-48bf-47bb-a7f3-36171ca1f9d7.html,,,,,, "Stearic acid, cobalt salt",13586-84-0,"Acute oral toxicity:LD50(female rats)>2000mg/kg bwAcute toxicity, dermal:Conduct of an acute dermal toxicity study is unjustified since dermal uptake is considered negligible (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006).Acute toxicity, inhalation:Testing is technically not feasible. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ab9779e-dc1a-483f-9ca5-f51f2e4ead97/documents/IUC5-0620fe63-500e-4f53-8c2c-50fadfff633f_eef95c20-5538-4c5a-936e-5499f811e780.html,,,,,, Stearoyl chloride,112-76-5,No death occurred at concentrations up to 3850 mg/kg. The LD50 value is > 5000 mg/kg. Therefore the test substance is considered to be low toxicity after oral administration. No death occurred when animals are exposed to a saturated atmosphere of stearoyl chloride for 8 h. The inhalation of a saturated atmosphere represents no acute hazard. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9a3c0fb-596a-429f-97d8-7d7ccbef0e74/documents/IUC5-fd424a94-b63a-4c22-83a8-df1b7234b590_45399d22-692b-4db9-bc80-846302c68ad8.html,,,,,, Stearoyl chloride,112-76-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9a3c0fb-596a-429f-97d8-7d7ccbef0e74/documents/IUC5-fd424a94-b63a-4c22-83a8-df1b7234b590_45399d22-692b-4db9-bc80-846302c68ad8.html,,oral,LD50,"5,783 mg/kg bw",no adverse effect observed, Strontium,7440-24-6,"Read-across: Strontium metal is highly reactive and instantly oxidizes upon contact with water. It decomposes completely. During the redox-reaction with water, a strong evolution of hydrogen gas and an immediate precipitation of a white, crystalline solid (i.e. Sr(OH)2) is observed (Sr2+ + 2OH- + H2 (g). The amount of dissolved Sr cations is determined by the solubility of the Sr(OH)2 precipitate. According to OECD guideline 105 (1995) and EU method A.6 (2006), the water solubility of strontium was determined to be 6.74 ± 0.14 g/L under the conditions of the test (flask method under protective gas atmosphere; loading of 41 g Sr/L, at 20.0 ± 1.0 °C, pH >13). Strontium ions are highly mobile, occur only in one valence state (2+), i.e. are not oxidized or reduced, and do not form strong complexes with most inorganic and organic ligands (Krupka et al. 1999. EPA 402-R-99-004B; Salminen et al. 2015; Carbonaro and Di Toro. 2007. Geochim Cosmochim Acta 71 3958–3968; Carbonaro et al. 2011. Geochim Cosmochim Acta 75: 2499-2511 and references therein). Thus, it may be assumed that systemic toxicological effects (not local) are related to the strontium ion. Therefore, the assessment of systemic toxicity of strontium is based on elemental strontium concentrations. Read-across of systemic toxicity data available for soluble strontium substances is applied since the strontium ions determine the toxicological potential of strontium. Read-across from strontium chloride hexahydrate to strontium is possible since as a first surrogate for bioavailability, the solubility of a test substance in water may be applied. Both substances (strontium chloride hexahydrate and strontium) are soluble (> 5 g/L). Hence, it can be concluded that adverse effects observed with strontium chloride hexahydrate are due to the presence of the strontium ion and are relevant for strontium metal. The NOAEL (males) of 300 ppm strontium chloride hexahydrate (equivalent to 30 mg/kg/day, nominal) was derived, based on the significant increase of the relative thyroid weights, found for the males at the 1200 ppm and 4800 ppm dose levels. The substance NOAEL corresponds to NOAEL (males) of 9.9 mg strontium/kg/day (nominal). The study is used as key study since it nearly meets the requirements of the current test guideline for oral sub-chronic exposure, however, the study was not performed under GLP (Klimisch score=2). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfbbc289-0b5e-4bd9-a1d9-1e8ba27791d6/documents/52f4d328-866e-4e3e-bc56-60888c433268_57e2ea00-e247-459a-9a1e-a6bdacb8db0e.html,,,,,, Strontium,7440-24-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfbbc289-0b5e-4bd9-a1d9-1e8ba27791d6/documents/52f4d328-866e-4e3e-bc56-60888c433268_57e2ea00-e247-459a-9a1e-a6bdacb8db0e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,9.9 mg/kg bw/day,,rat Strontium,7440-24-6,"Studies on the acute toxicity via the oral, dermal or inhalation route should not be conducted since strontium is corrosive to skin and eye (pH≥11.5). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfbbc289-0b5e-4bd9-a1d9-1e8ba27791d6/documents/4ac036be-b8b0-43c7-99de-6bd289952949_57e2ea00-e247-459a-9a1e-a6bdacb8db0e.html,,,,,, Strontium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,73612-29-0," The NOAEL for chronic oral toxicity is established at 25 mg/kg bw based on repeated dose toxicity studies with analogue substances. Higher doses result in kidney damage. This is derived from subacute gavage studies with Pigment Red 57:1(Ca) (OECD 422, GLP, MHLW 1993), Pigment Red 48:2(Ca) (OECD 422, GLP, MHLW 2009) and Pigment Red 57(Sr) (OECD 407, GLP, DIC 2006). In a chronic feeding study with the sodium salt of Pigment Red 57(Na), exacerbation of spontaneous renal disease in aged rats was observed with a NOAEL of 0.05 % (CTFA 1981). The dietary concentration of 0.05% corresponds to an average dose of 26 mg/kg bw for males and 31 mg/kg bw for females. No histopathology findings on kidneys were reported after a two-year skin painting study with mice with Pigment Red 57:1(Ca) (Carson 1984). Regarding the cation, available data indicate that the data available for the Pigments covers the hazard of both the related anion and cation. The amine that would be liberated from azo reduction caused no adverse effects upon subacute oral toxicity at the limit dose of 1000 mg/kg bw (MHLW). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97ce7f03-ca2c-4d1c-b3fa-2306ee5533b8/documents/IUC5-44d46a69-8414-4bf3-9e3a-e45d18a622e1_fba9ef1b-1cd6-493a-9599-2a28169192dd.html,,,,,, Strontium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,73612-29-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97ce7f03-ca2c-4d1c-b3fa-2306ee5533b8/documents/IUC5-44d46a69-8414-4bf3-9e3a-e45d18a622e1_fba9ef1b-1cd6-493a-9599-2a28169192dd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Strontium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,73612-29-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97ce7f03-ca2c-4d1c-b3fa-2306ee5533b8/documents/IUC5-44d46a69-8414-4bf3-9e3a-e45d18a622e1_fba9ef1b-1cd6-493a-9599-2a28169192dd.html,Chronic toxicity – systemic effects,dermal,NOAEL,50 mg/kg bw/day,,mouse Strontium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,73612-29-0," Studies of Pigment Red 57 -Sr and of other members of the same category indicate that Pigment Red 57 -Sr is not acutely toxic via the oral, inhalation, and dermal route of exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97ce7f03-ca2c-4d1c-b3fa-2306ee5533b8/documents/IUC5-bbd7b923-c277-493d-94a5-4b21c28b9673_fba9ef1b-1cd6-493a-9599-2a28169192dd.html,,,,,, Strontium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,73612-29-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97ce7f03-ca2c-4d1c-b3fa-2306ee5533b8/documents/IUC5-bbd7b923-c277-493d-94a5-4b21c28b9673_fba9ef1b-1cd6-493a-9599-2a28169192dd.html,,oral,LD50,"2,200 mg/kg bw",no adverse effect observed, Strontium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,73612-29-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97ce7f03-ca2c-4d1c-b3fa-2306ee5533b8/documents/IUC5-bbd7b923-c277-493d-94a5-4b21c28b9673_fba9ef1b-1cd6-493a-9599-2a28169192dd.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, Strontium 3-hydroxy-4-[(4-methyl-2-sulphonatophenyl)azo]-2-naphthoate,73612-29-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97ce7f03-ca2c-4d1c-b3fa-2306ee5533b8/documents/IUC5-bbd7b923-c277-493d-94a5-4b21c28b9673_fba9ef1b-1cd6-493a-9599-2a28169192dd.html,,inhalation,LC50,"1,518 mg/m3",no adverse effect observed, Strontium 4-[(4-chloro-5-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (1:1),67828-72-2," Experimental data on acute toxicity of Pigment Red 52 -Sr are not available. Results from a members of the same category indicate that Pigment Red 52 -Sr is not acutely toxic via the oral, inhalation, and dermal route of exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/590b4ca1-6116-4037-9117-d59b3baf98e5/documents/IUC5-76d99efe-a11e-42ab-80f7-292286f7cb2c_8843592f-fa5c-4102-b6c1-170b52164a6a.html,,,,,, Strontium 4-[(4-chloro-5-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (1:1),67828-72-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/590b4ca1-6116-4037-9117-d59b3baf98e5/documents/IUC5-76d99efe-a11e-42ab-80f7-292286f7cb2c_8843592f-fa5c-4102-b6c1-170b52164a6a.html,,oral,LD50,"6,400 mg/kg bw",no adverse effect observed, Strontium 4-[(4-chloro-5-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (1:1),67828-72-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/590b4ca1-6116-4037-9117-d59b3baf98e5/documents/IUC5-76d99efe-a11e-42ab-80f7-292286f7cb2c_8843592f-fa5c-4102-b6c1-170b52164a6a.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, Strontium 4-[(4-chloro-5-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (1:1),67828-72-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/590b4ca1-6116-4037-9117-d59b3baf98e5/documents/IUC5-76d99efe-a11e-42ab-80f7-292286f7cb2c_8843592f-fa5c-4102-b6c1-170b52164a6a.html,,inhalation,LC50,"1,518 mg/m3",no adverse effect observed, Strontium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (1:1),15782-05-5," The NOAEL for chronic oral toxicity is established at 25 mg/kg bw based on repeated dose toxicity studies with analogue substances. Higher doses result in kidney damage. This is derived from subacute gavage studies with Pigment Red 57:1(Ca) (OECD 422, GLP, MHLW 1993), Pigment Red 48:2(Ca) (OECD 422, GLP, MHLW 2009) and Pigment Red 57(Sr) (OECD 407, GLP, DIC 2006). No histopathology findings on kidneys were reported after a two-year skin painting study with mice with Pigment Red 57:1(Ca) (Carson 1984). Regarding the cation, available data indicate that the data available for the Pigments covers the hazard of both the related anion and cation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72330dc0-2d56-463d-a1fd-04a80267a4c6/documents/IUC5-d99248c0-3ef8-4191-9485-4881526500fa_ab92330a-0e1c-46b5-8b31-6ec46ad79863.html,,,,,, Strontium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (1:1),15782-05-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72330dc0-2d56-463d-a1fd-04a80267a4c6/documents/IUC5-d99248c0-3ef8-4191-9485-4881526500fa_ab92330a-0e1c-46b5-8b31-6ec46ad79863.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Strontium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (1:1),15782-05-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72330dc0-2d56-463d-a1fd-04a80267a4c6/documents/IUC5-d99248c0-3ef8-4191-9485-4881526500fa_ab92330a-0e1c-46b5-8b31-6ec46ad79863.html,Chronic toxicity – systemic effects,dermal,NOAEL,50 mg/kg bw/day,,mouse Strontium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (1:1),15782-05-5," Studies of Pigment Red 48:3 and of other members of the same category indicate that Pigment Red 48:3 is not acutely toxic via the oral, inhalation, and dermal route of exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72330dc0-2d56-463d-a1fd-04a80267a4c6/documents/IUC5-15b88a1e-0e4b-4e6b-975c-d3ee60aecb62_ab92330a-0e1c-46b5-8b31-6ec46ad79863.html,,,,,, Strontium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (1:1),15782-05-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72330dc0-2d56-463d-a1fd-04a80267a4c6/documents/IUC5-15b88a1e-0e4b-4e6b-975c-d3ee60aecb62_ab92330a-0e1c-46b5-8b31-6ec46ad79863.html,,oral,LD50,"2,900 mg/kg bw",no adverse effect observed, Strontium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (1:1),15782-05-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72330dc0-2d56-463d-a1fd-04a80267a4c6/documents/IUC5-15b88a1e-0e4b-4e6b-975c-d3ee60aecb62_ab92330a-0e1c-46b5-8b31-6ec46ad79863.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, Strontium 4-[(5-chloro-4-methyl-2-sulphonatophenyl)azo]-3-hydroxy-2-naphthoate (1:1),15782-05-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72330dc0-2d56-463d-a1fd-04a80267a4c6/documents/IUC5-15b88a1e-0e4b-4e6b-975c-d3ee60aecb62_ab92330a-0e1c-46b5-8b31-6ec46ad79863.html,,inhalation,LC50,"1,518 mg/m3",no adverse effect observed, Strontium bis(2-ethylhexanoate),2457-02-5," No repeated dose toxicity study with strontium bis(2-ethylhexanoate) is available, thus the repeated dose toxicity will be addressed with existing data on the individual moieties strontium and 2‑ethylhexanoic acid. In relevant and reliable repeated dose toxicity studies for both moieties of strontium bis(2-ethylhexanoate), there were no toxicological findings reported that would justify a classification. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b98e14e1-0c16-4607-ad34-91e421b9bf2c/documents/17702184-75c3-46ff-afc1-63ef220ccac1_e63885d7-670c-4482-a79e-da089f9819cf.html,,,,,, Strontium bis(2-ethylhexanoate),2457-02-5,The experimentally measured oral LD50 for strontium bis (2-ethylhexanoate) is >2000 mg /kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b98e14e1-0c16-4607-ad34-91e421b9bf2c/documents/51a405ee-eea3-429c-9884-19dbd92c37e3_e63885d7-670c-4482-a79e-da089f9819cf.html,,,,,, Strontium bis(2-ethylhexanoate),2457-02-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b98e14e1-0c16-4607-ad34-91e421b9bf2c/documents/51a405ee-eea3-429c-9884-19dbd92c37e3_e63885d7-670c-4482-a79e-da089f9819cf.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Strontium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate],73263-40-8,"Repeated dose toxicity of the test substance was not examined. Reliable experimental data of an analogue substance are available. Three studies are suitable to provide information on toxicity after repeated dose administration. The subacute toxicity study in rats at dose levels up to 5% (unknown purity) revealed formation of Heinzbodies, changes in hematology and pathological and histopathological changes in splenn and kidney. The 90d study at dose levels up to 10000 ppm which served as range finder for a cancer study confirms the findings of the 28d study. Additionally, congestion of the spleen and hemosiderosis in the liver was observed. A chronic study in mice at dose levels up to 1000 ppm revealed no adverse effects than changes in hematology. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d29b5d9-b79e-4737-9d5d-f19d6f9b079c/documents/IUC5-782051f1-8107-412b-b4a0-41769fb00c02_8be8ebea-e707-423e-91a8-b5880a624f4c.html,,,,,, Strontium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate],73263-40-8,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5d29b5d9-b79e-4737-9d5d-f19d6f9b079c/documents/IUC5-782051f1-8107-412b-b4a0-41769fb00c02_8be8ebea-e707-423e-91a8-b5880a624f4c.html,Chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,mouse Strontium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate],73263-40-8,"Studies on acute toxicity of the test item (Sr salt) were not performed. Since both substances are salts with similar structur and similar solubility, information on acute toxicity were derived from experimental data of a structural analogue (Ba salt). Four studies were performed to evaluate acute oral and inhalative toxicity of the test substance to the rat (according OECD 401 and 403). The test substance did not induce mortalities, abnormalities or clinical signs when applied oral. Also single administration via the respiratory system did not cause health effects or mortalities. The LD50 for oral toxicity is considered to be > 10.000 mg/kg bw, LC50 is > 5.24 mg/l air. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d29b5d9-b79e-4737-9d5d-f19d6f9b079c/documents/IUC5-24821341-e884-4330-81f6-02cfd9ff9bd6_8be8ebea-e707-423e-91a8-b5880a624f4c.html,,,,,, Strontium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate],73263-40-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d29b5d9-b79e-4737-9d5d-f19d6f9b079c/documents/IUC5-24821341-e884-4330-81f6-02cfd9ff9bd6_8be8ebea-e707-423e-91a8-b5880a624f4c.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Strontium bis[2-chloro-5-[(2-hydroxy-1-naphthyl)azo]toluene-4-sulphonate],73263-40-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d29b5d9-b79e-4737-9d5d-f19d6f9b079c/documents/IUC5-24821341-e884-4330-81f6-02cfd9ff9bd6_8be8ebea-e707-423e-91a8-b5880a624f4c.html,,inhalation,LC50,5.24 mg/m3,no adverse effect observed, Strontium carbonate,1633-05-2,Strontium carbonate is not expected to show effects at 12.4 mg SrCO3/kg bw/d (equivalent to 7.4 mg Sr/kg bw/d) based on the 90-day repeated dose toxicity study conducted with strontium chloride. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14560ad9-7d95-4966-a31d-171e92e3a8f5/documents/IUC5-3af258ed-315b-43ee-a395-d69e65d35ef8_3cf3c963-ca1b-43d6-a798-8c985871641c.html,,,,,, Strontium carbonate,1633-05-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/14560ad9-7d95-4966-a31d-171e92e3a8f5/documents/IUC5-3af258ed-315b-43ee-a395-d69e65d35ef8_3cf3c963-ca1b-43d6-a798-8c985871641c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,12.4 mg/kg bw/day,,rat Strontium carbonate,1633-05-2,"Acute toxicity, oral: LD50 > 1395 mg/kg bw (> 828 mg Sr/kg bw)Acute toxicity, inhalation: LD50 > 5 mg/LAcute toxicity, dermal: data waiving ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14560ad9-7d95-4966-a31d-171e92e3a8f5/documents/IUC5-506f6ea7-6371-4f49-97e2-cfb258e862ab_3cf3c963-ca1b-43d6-a798-8c985871641c.html,,,,,, Strontium carbonate,1633-05-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14560ad9-7d95-4966-a31d-171e92e3a8f5/documents/IUC5-506f6ea7-6371-4f49-97e2-cfb258e862ab_3cf3c963-ca1b-43d6-a798-8c985871641c.html,,oral,LD50,"> 1,395 mg/kg bw",no adverse effect observed, Strontium carbonate,1633-05-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14560ad9-7d95-4966-a31d-171e92e3a8f5/documents/IUC5-506f6ea7-6371-4f49-97e2-cfb258e862ab_3cf3c963-ca1b-43d6-a798-8c985871641c.html,,inhalation,LC50,> 5 mg/L,no adverse effect observed, Strontium hydrogen phosphate,13450-99-2,"Two publications are available on feeding studies which address a broad range of parameters: Kroes et al (1977; SrCl2.6H2O) and Kshirsagar (1975; Sr3(PO4)2). Several publications are available on effects of repeated Sr exposure via feed or drinking water (SrCl2 or Sr as unspecified salt) specifically on bone parameters. All studies were performed with rats. The rationale for the use of data from substance analogues is included in section 13. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Several publications with Klimisch reliability 2 are available on SrCl2. One publication is available on effects of Strontium phosphate (Klimisch 2). Three publications on Strontium are available with Klimisch score 2, without further data on the Strontium salt used. All studies were perfomed with rats. The hypothesis for the analogue approach is attached in section 13. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9505396-76fa-4e33-a5ea-5271d2b9be20/documents/d5078ee4-67a8-4c57-90c4-0bf5114f5464_bb46eab4-2327-4c83-bcc7-3e6c98d50475.html,,,,,, Strontium hydrogen phosphate,13450-99-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a9505396-76fa-4e33-a5ea-5271d2b9be20/documents/d5078ee4-67a8-4c57-90c4-0bf5114f5464_bb46eab4-2327-4c83-bcc7-3e6c98d50475.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,104 mg/kg bw/day,,rat Strontium hydrogen phosphate,13450-99-2,"Based on the results of a feeding study (Kshirsagar 1975) in which rats were exposed to a maximum concentration of 2000 mg/kg bw/ day, it can be concluded that the LD50 for acute oral toxicity for strontium phosphate is > 2000mg/kg bw. The LD50 of the substance analogue Strontium chloride for rats and mice were reported to be 2.250 and 3100 mg/kg bw respectively (Calvery, 1942 and Woodard, G; Calvery, HO (1941)). The LD50 of the substance analogue strontium nitrate for mice is reported to be 5675 mg/kg bw (Llobet et al. 1991). The hypothesis for the analogue approach is attached in section 13.   Based on an acute inhalation study performed with Strontium nitrate according to OECD guideline and GLP principles, the inhalatory LC50 of strontium nitrate in Wistar rats was considered to be >4.5 +/- 0.6 mg/l. According to the rationale attached in section 13, these data can be read across to Strontiumhydrogenphosphate. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliability: 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): This study has been performed according to OECD and/or EC guidelines and according to GLP principles. According to ECHA's practical guide 6: ""How to report read-across and categories"" the maximum reliability for as study performed with a substance analogue is 2. The hypothesis for the analogue approach is attached in section 13. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9505396-76fa-4e33-a5ea-5271d2b9be20/documents/24457422-8c08-453b-8837-90ec89892e7c_bb46eab4-2327-4c83-bcc7-3e6c98d50475.html,,,,,, Strontium hydrogen phosphate,13450-99-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9505396-76fa-4e33-a5ea-5271d2b9be20/documents/24457422-8c08-453b-8837-90ec89892e7c_bb46eab4-2327-4c83-bcc7-3e6c98d50475.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Strontium hydrogen phosphate,13450-99-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9505396-76fa-4e33-a5ea-5271d2b9be20/documents/24457422-8c08-453b-8837-90ec89892e7c_bb46eab4-2327-4c83-bcc7-3e6c98d50475.html,,inhalation,LC50,"4,500 mg/m3",no adverse effect observed, Strontium neodecanoate,106705-37-7,"No repeated dose toxicity study with strontium neodecanoate is available, thus the repeated dose toxicity will be addressed with existing data on the individual moieties strontium and neodecanoic acid. In relevant and reliable repeated dose toxicity studies for both moieties of strontium neodecanoate, there were no toxicological findings reported that would justify a classification. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75bba963-6084-4be2-a6c3-3bc8ba2c90f5/documents/IUC5-4dd59fcb-fef5-4cad-8334-c6731e784007_0c5dfce3-056b-42cf-92cc-1cd5ddea45a8.html,,,,,, Strontium neodecanoate,106705-37-7,"The experimentally measured oral LD50 for strontium neodecanoate is 1030 mg/kg bw (OECD 425; GLP compliant).   No acute dermal toxicity study is available, thus the acute dermal toxicity will be addressed with existing data on the dissociation products strontium and neodecanoate. Signs of acute dermal toxicity are not expected for strontium neodecanoate, since dermal absorption of the moiety strontium is low and the moiety neodecanoate have not shown signs of acute dermal toxicity in experimental testing (LD50 > 2000 mg/kg). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75bba963-6084-4be2-a6c3-3bc8ba2c90f5/documents/IUC5-d26df387-8126-44bd-8ab6-0610eded081f_0c5dfce3-056b-42cf-92cc-1cd5ddea45a8.html,,,,,, Strontium neodecanoate,106705-37-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75bba963-6084-4be2-a6c3-3bc8ba2c90f5/documents/IUC5-d26df387-8126-44bd-8ab6-0610eded081f_0c5dfce3-056b-42cf-92cc-1cd5ddea45a8.html,,oral,LD50,"1,030 mg/kg bw",adverse effect observed, Strontium oxalate,814-95-9," Toxicity of oxalic acid is considered in a read-across approach. In a single oral toxicity test with a 5% aqueous solution of oxalic acid, an LD50 of 9.5 mL/kg was determined in male rats, and an LD50 of 7.5 mL/kg was determined in female rats, under the current test conditions. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4df9c767-b8a3-49c3-996b-7fae763f2d11/documents/d307b10d-b1d9-4f9e-9721-bacbf794a8b6_0eb51761-d76e-48eb-9af5-c04b70660c1b.html,,,,,, Strontium oxalate,814-95-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4df9c767-b8a3-49c3-996b-7fae763f2d11/documents/d307b10d-b1d9-4f9e-9721-bacbf794a8b6_0eb51761-d76e-48eb-9af5-c04b70660c1b.html,,oral,LD50,304.87 mg/kg bw,adverse effect observed, Strontium oxide,1314-11-0,"No repeated dose toxicity study with strontium oxide is available. Since strontium oxide completely dissolves upon contact and during the reaction with water andbased on the assumption that strontium is the moiety of concern,the repeated dose toxicity will be addressed only with existing data on the moiety strontium.  In a relevant and reliable repeated dose toxicity study conducted with strontium dichloride hexahydrate, no toxicological findings were reported that would justify a classification for specific target organ toxicity with repeated exposure. Thus, strontium oxide does not have to be classified. The NOAEL (males) of 300 ppm strontium chloride hexahydrate (equivalent to 30 mg/kg/day, nominal) was derived, based on the significant increase of the relative thyroid weights, found for the males at the 1200 ppm and 4800 ppm dose levels. The substance NOAEL corresponds to NOAEL (males) of 11.7 mg strontium oxide/kg/day (nominal). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7b934e4-1d19-4c76-8abe-91c70fe5c7ad/documents/89a80099-b344-49bb-87ef-679ca1656ac5_0bc1b0a6-748e-4645-9446-ae7b9ca3eeaa.html,,,,,, Strontium oxide,1314-11-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7b934e4-1d19-4c76-8abe-91c70fe5c7ad/documents/89a80099-b344-49bb-87ef-679ca1656ac5_0bc1b0a6-748e-4645-9446-ae7b9ca3eeaa.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,11.7 mg/kg bw/day,, Strontium oxide,1314-11-0," Acute toxicity studies may not be conducted with strontium oxide, since the substance is corrosive to the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7b934e4-1d19-4c76-8abe-91c70fe5c7ad/documents/5d02c7d3-94dc-426e-a394-1b2f0e3faea3_0bc1b0a6-748e-4645-9446-ae7b9ca3eeaa.html,,,,,, Strontium sulphate,7759-02-6,Strontium sulfate is not expected to show effects at 26.0 mg SrSO4/kg bw/d based on the 90-day repeated dose toxicity study conducted with strontium chloride. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cba86d44-991c-4758-91c5-a35ca706dfab/documents/IUC5-e7b877fb-f84d-4757-82fa-b9afa8248f9b_c8f47f04-2332-48e3-905f-dd4cd0256031.html,,,,,, Strontium sulphate,7759-02-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cba86d44-991c-4758-91c5-a35ca706dfab/documents/IUC5-e7b877fb-f84d-4757-82fa-b9afa8248f9b_c8f47f04-2332-48e3-905f-dd4cd0256031.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,26 mg/kg bw/day,,rat Strontium sulphate,7759-02-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): study conducted with strontium nitrate, results re-calculated to strontium sulfate Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): study conducted with strontium nitrate, results re-calculated to strontium sulfate ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cba86d44-991c-4758-91c5-a35ca706dfab/documents/IUC5-72fc2595-842a-4153-b1e4-36a32f70e0b9_c8f47f04-2332-48e3-905f-dd4cd0256031.html,,,,,, Strontium sulphate,7759-02-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cba86d44-991c-4758-91c5-a35ca706dfab/documents/IUC5-72fc2595-842a-4153-b1e4-36a32f70e0b9_c8f47f04-2332-48e3-905f-dd4cd0256031.html,,oral,discriminating dose,"1,736 mg/kg bw",no adverse effect observed, Strontium sulphate,7759-02-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cba86d44-991c-4758-91c5-a35ca706dfab/documents/IUC5-72fc2595-842a-4153-b1e4-36a32f70e0b9_c8f47f04-2332-48e3-905f-dd4cd0256031.html,,inhalation,discriminating conc.,"3,900 mg/m3",no adverse effect observed, Strontium titanium trioxide,12060-59-2,"The oral administration of Strontium Titanium Trioxide to rats by gavage, at dose levels of 100, 300 and 1000 mg/kg bw/day, resulted in treatment-related changes at 1000 mg/kg bw/day. The effects detected were considered not to represent an adverse effect, therefore the ‘No Observed Adverse Effect Level’ (NOAEL) for systemic toxicity was considered to be 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f831b64c-8373-41e4-91ac-a638a7cf8f3a/documents/IUC5-236aa8af-5c57-403c-acb2-bfb5d0ec2419_ee8d10cc-f082-48f6-97c8-a6627e7e0710.html,,,,,, Strontium titanium trioxide,12060-59-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f831b64c-8373-41e4-91ac-a638a7cf8f3a/documents/IUC5-236aa8af-5c57-403c-acb2-bfb5d0ec2419_ee8d10cc-f082-48f6-97c8-a6627e7e0710.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Strontium titanium trioxide,12060-59-2,The acute lethal oral dose (LD50) to rats of ST888YK was demonstrated to be greater than 2000 mg/kg bodyweight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f831b64c-8373-41e4-91ac-a638a7cf8f3a/documents/IUC5-4f6dcae2-1e20-4971-b291-137003de63a1_ee8d10cc-f082-48f6-97c8-a6627e7e0710.html,,,,,, Strontium titanium trioxide,12060-59-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f831b64c-8373-41e4-91ac-a638a7cf8f3a/documents/IUC5-4f6dcae2-1e20-4971-b291-137003de63a1_ee8d10cc-f082-48f6-97c8-a6627e7e0710.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Suberonitrile,629-40-3,"Oral (Standard Acute Method), rat: LD50: 396 mg/kg bw, 1986; RL = 1Oral (Standard Acute Method), rat: LD50: 242 mg/kg bw, 1984; RL = 2Oral (Standard Acute Method), mouse: LD50: 141 mg/kg bw, 1963; RL = 2Oral (Standard Acute Method), rabbit: LD50: 35 mg/kg bw, 1964; RL = 2Oral (Standard Acute Method), cat: LD50: 35 mg/kg bw, 1964; RL = 2Inhalative (Inhalation Hazard Test), LC0 = 1.24 mg/L air (nominal), 1963; RL = 2Dermal (Limit test), rat: LD0 = 1884 mg/kg bw, 1963; RL = 4 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0fcc5ad3-c536-4819-bad6-d6887fa43e18/documents/IUC5-dfd97bd4-53a3-4b26-bd6d-e7081d167404_0d6eccdf-1c8e-4506-9ef5-c5a937495ad0.html,,,,,, Succinimide,123-56-8, Three acute toxicity studie for succinimide are available. In two acute oral studies an LD50 has been determined of 14 g/kg bw for rats and 11 g/kg bw for mice. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ce80232-56f4-431d-af61-fe1724fd4cf0/documents/IUC5-e84aec47-4058-4546-941e-19594f6ccc26_08c2ef13-a6a7-4bbe-8beb-8ac1b995a645.html,,,,,, Succinimide,123-56-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ce80232-56f4-431d-af61-fe1724fd4cf0/documents/IUC5-e84aec47-4058-4546-941e-19594f6ccc26_08c2ef13-a6a7-4bbe-8beb-8ac1b995a645.html,,oral,LD50,"11,000 mg/kg bw",no adverse effect observed, "Sucrose, propoxylated",9049-71-2,"NOAEL (28 days repeated dose, Wistar): ≥ 1000 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f17e116d-3684-434f-a7f9-3e3499d0d131/documents/IUC5-8f39e01b-7f48-4108-a43a-f659302a5ce4_54e4f269-e957-47d2-a3df-f62c41741ce0.html,,,,,, "Sucrose, propoxylated",9049-71-2,Acute toxicity via oral route were determined as > 2000 mg/kg bw (Bayer study)  and > 5000 mg/kg bw (Dow study). The acute toxicity via the dermal route of exposure was > 5000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f17e116d-3684-434f-a7f9-3e3499d0d131/documents/IUC5-2164f8bf-99d2-4d28-9af3-73768bd903d1_54e4f269-e957-47d2-a3df-f62c41741ce0.html,,,,,, "Sulfite liquors and Cooking liquors, green",68131-30-6,"Green liquor is highly alkaline and corrosive substance. Test results on animals is not available. Animal testing is not an appropriate way to clarify repeated dose toxicity of this substance. Read-across from analogous substances/constituents has been used and can contribute to the procedure for hazard identification and DNEL derivation. DNEL levels are derived applying existing data on lowest reliable and relevant test results of critical constituents (hydroxides (OH-) and sulfides (S=)) of GL.  Inhalation route is also regarded as relevant since GL mists and H2S gases are generated during manufacturing, handling and downstream use of GL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac593b77-b984-4767-b096-5a64abaa2df2/documents/IUC5-91b03ea2-89c0-4a16-b627-be0d6364380f_aea2e04d-d52e-47f4-8c00-b66b95b453c9.html,,,,,, "Sulfite liquors and Cooking liquors, green",68131-30-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac593b77-b984-4767-b096-5a64abaa2df2/documents/IUC5-91b03ea2-89c0-4a16-b627-be0d6364380f_aea2e04d-d52e-47f4-8c00-b66b95b453c9.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,80 mg/kg bw/day,,rat "Sulfite liquors and Cooking liquors, green",68131-30-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ac593b77-b984-4767-b096-5a64abaa2df2/documents/IUC5-91b03ea2-89c0-4a16-b627-be0d6364380f_aea2e04d-d52e-47f4-8c00-b66b95b453c9.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,14 mg/m3,,rat "Sulfite liquors and Cooking liquors, green",68131-30-6, Green liquor is acutely toxic in oral exposure. No tested information is available on acute toxicity via dermal and inhalation route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac593b77-b984-4767-b096-5a64abaa2df2/documents/IUC5-4dd2f538-0346-4420-a18a-e5ff6eabf384_aea2e04d-d52e-47f4-8c00-b66b95b453c9.html,,,,,, "Sulfite liquors and Cooking liquors, green",68131-30-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ac593b77-b984-4767-b096-5a64abaa2df2/documents/IUC5-4dd2f538-0346-4420-a18a-e5ff6eabf384_aea2e04d-d52e-47f4-8c00-b66b95b453c9.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "Sulfite liquors and Cooking liquors, white",68131-33-9,"- Due to the high alkalinity and corrosivity of White liquor the acute toxicity tests are not applicable for investigating the substance.- There is no available information of acute oral, dermal or inhalation toxicity concerning White liquor. The maximum expected concentration of one identified main ingredient (disodium sulphide) holding a harmonized classification does not suggest an acute toxicity classification for White liquor according to CLP regulation 1272/2008 (ATE>2000), but indicates need for classification for acute dermal toxicity according to DSD/DPD rules (67/548/EEC). - In contact with acids, White liquor may release toxic and flammable hydrogen sulfide gas (H2S). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e5adc5d-05f1-425d-b651-c766fb52f3e1/documents/IUC5-56b83423-17e2-44cb-b875-690887869e5c_b6a47e32-fd71-4aa3-a8e5-dd931687e2a3.html,,,,,, "Sulfonic acids, C14-18-alkane hydroxy and C12-20-alkapolyene and C14-18-alkene and C12-20-alkene hydroxy, sodium salts",68937-98-4," Acute toxicity, oral (rat): 300 mg/kg bodyweight < LD50 < 2000 mg/kg bodyweight ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/65e3bf27-fb0e-446c-baac-4da446ea66a3/documents/e1334a25-eff9-4751-a346-fb2524b6e2d4_2a3cc8c6-2833-4924-a15b-76a5d29d376b.html,,,,,, "Sulfonic acids, petroleum",61789-85-3,"The toxicity of the substance has been assessed by the repeated exposure over a period of 28-days by the three routes of exposure, oral, dermal and inhalation. Effects observed by oral exposure demonstrate a reduction in serum cholesterol at the highest tested dose. Furthermore, the results obtained by inhalation exposure are considered unsuitable for determination of the intrinsic hazard of the substance by inhalation due to the high proportion of mineral oil in the test sample [Test material: Product as manufactured in mineral oil solvent further diluted in mineral oil (65/35)]. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf451509-6826-4cc0-aac8-65327fe70cee/documents/IUC5-9b9640ef-3023-43a5-ad59-fa82e2df9600_68893f12-c8de-4aa1-8615-5dc278820d1f.html,,,,,, "Sulfonic acids, petroleum",61789-85-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf451509-6826-4cc0-aac8-65327fe70cee/documents/IUC5-9b9640ef-3023-43a5-ad59-fa82e2df9600_68893f12-c8de-4aa1-8615-5dc278820d1f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Sulfonic acids, petroleum",61789-85-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf451509-6826-4cc0-aac8-65327fe70cee/documents/IUC5-9b9640ef-3023-43a5-ad59-fa82e2df9600_68893f12-c8de-4aa1-8615-5dc278820d1f.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Sulfonic acids, petroleum",61789-85-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf451509-6826-4cc0-aac8-65327fe70cee/documents/IUC5-9b9640ef-3023-43a5-ad59-fa82e2df9600_68893f12-c8de-4aa1-8615-5dc278820d1f.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,881.58 mg/m3,,rat "Sulfonic acids, petroleum",61789-85-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf451509-6826-4cc0-aac8-65327fe70cee/documents/IUC5-9b9640ef-3023-43a5-ad59-fa82e2df9600_68893f12-c8de-4aa1-8615-5dc278820d1f.html,Repeated dose toxicity – local effects,dermal,NOAEL,5.13 mg/cm2,adverse effect observed,other:human volunteers and laboratory species "Sulfonic acids, petroleum",61789-85-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bf451509-6826-4cc0-aac8-65327fe70cee/documents/IUC5-9b9640ef-3023-43a5-ad59-fa82e2df9600_68893f12-c8de-4aa1-8615-5dc278820d1f.html,Repeated dose toxicity – local effects,inhalation,NOAEC,881.58 mg/m3,adverse effect observed,rat "Sulfonic acids, petroleum",61789-85-3,"Acute mammalian toxicity in rats, exposed by the oral gavage, inhalation and dermal routes ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf451509-6826-4cc0-aac8-65327fe70cee/documents/IUC5-290df99c-c7bf-4cbf-90d9-5cc6a5f2ec20_68893f12-c8de-4aa1-8615-5dc278820d1f.html,,,,,, "Sulfonic acids, petroleum",61789-85-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf451509-6826-4cc0-aac8-65327fe70cee/documents/IUC5-290df99c-c7bf-4cbf-90d9-5cc6a5f2ec20_68893f12-c8de-4aa1-8615-5dc278820d1f.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Sulfonic acids, petroleum",61789-85-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf451509-6826-4cc0-aac8-65327fe70cee/documents/IUC5-290df99c-c7bf-4cbf-90d9-5cc6a5f2ec20_68893f12-c8de-4aa1-8615-5dc278820d1f.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Sulfonic acids, petroleum",61789-85-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf451509-6826-4cc0-aac8-65327fe70cee/documents/IUC5-290df99c-c7bf-4cbf-90d9-5cc6a5f2ec20_68893f12-c8de-4aa1-8615-5dc278820d1f.html,,inhalation,LC50,1.9 mg/m3,no adverse effect observed, "Sulfonic acids, petroleum, magnesium salts",61789-87-5,"The toxicity of the substance has been assessed by the repeated exposure over a period of 28-days by the three routes of exposure, oral, dermal and inhalation. Effects observed by oral exposure demonstrate a reduction in serum cholesterol at the highest tested dose. Furthermore, the results obtained by inhalation exposure are considered unsafe for determination of the intrinsic hazard of the substance by inhalation due to the a high proportion (65%) of mineral oil in the test sample. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/344cf819-1363-4c6f-a38f-421e27953c4d/documents/IUC5-cc483acb-9b90-4e25-b0ad-d7754784f1b0_ffc9f6c2-cdc5-421a-a046-d8aa05313552.html,,,,,, "Sulfonic acids, petroleum, magnesium salts",61789-87-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/344cf819-1363-4c6f-a38f-421e27953c4d/documents/IUC5-cc483acb-9b90-4e25-b0ad-d7754784f1b0_ffc9f6c2-cdc5-421a-a046-d8aa05313552.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Sulfonic acids, petroleum, magnesium salts",61789-87-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/344cf819-1363-4c6f-a38f-421e27953c4d/documents/IUC5-cc483acb-9b90-4e25-b0ad-d7754784f1b0_ffc9f6c2-cdc5-421a-a046-d8aa05313552.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Sulfonic acids, petroleum, magnesium salts",61789-87-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/344cf819-1363-4c6f-a38f-421e27953c4d/documents/IUC5-cc483acb-9b90-4e25-b0ad-d7754784f1b0_ffc9f6c2-cdc5-421a-a046-d8aa05313552.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,881.58 mg/m3,,rat "Sulfonic acids, petroleum, magnesium salts",61789-87-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/344cf819-1363-4c6f-a38f-421e27953c4d/documents/IUC5-cc483acb-9b90-4e25-b0ad-d7754784f1b0_ffc9f6c2-cdc5-421a-a046-d8aa05313552.html,Repeated dose toxicity – local effects,dermal,NOAEL,"1,000 mg/cm2",adverse effect observed,rat "Sulfonic acids, petroleum, magnesium salts",61789-87-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/344cf819-1363-4c6f-a38f-421e27953c4d/documents/IUC5-cc483acb-9b90-4e25-b0ad-d7754784f1b0_ffc9f6c2-cdc5-421a-a046-d8aa05313552.html,Repeated dose toxicity – local effects,inhalation,NOAEC,881.58 mg/m3,adverse effect observed,rat "Sulfonic acids, petroleum, magnesium salts",61789-87-5,"Acute mammalian toxicity in rats, exposed by the oral gavage, inhalation and dermal routes ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/344cf819-1363-4c6f-a38f-421e27953c4d/documents/IUC5-b9c7697a-d0d8-4d4e-bd0a-acf1df7cbaff_ffc9f6c2-cdc5-421a-a046-d8aa05313552.html,,,,,, "Sulfonic acids, petroleum, magnesium salts",61789-87-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/344cf819-1363-4c6f-a38f-421e27953c4d/documents/IUC5-b9c7697a-d0d8-4d4e-bd0a-acf1df7cbaff_ffc9f6c2-cdc5-421a-a046-d8aa05313552.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Sulfonic acids, petroleum, magnesium salts",61789-87-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/344cf819-1363-4c6f-a38f-421e27953c4d/documents/IUC5-b9c7697a-d0d8-4d4e-bd0a-acf1df7cbaff_ffc9f6c2-cdc5-421a-a046-d8aa05313552.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Sulfonic acids, petroleum, magnesium salts",61789-87-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/344cf819-1363-4c6f-a38f-421e27953c4d/documents/IUC5-b9c7697a-d0d8-4d4e-bd0a-acf1df7cbaff_ffc9f6c2-cdc5-421a-a046-d8aa05313552.html,,inhalation,LC50,1.9 mg/m3,no adverse effect observed, "Sulfonic acids, petroleum, sodium salts",68608-26-4,"The toxicity of the substance has been assessed by the repeated exposure over a period of 28-days by the three routes of exposure, oral, dermal and inhalation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e95841b7-8d0f-4bb5-9140-f4e21c44e973/documents/IUC5-e4f97147-c201-4509-92c7-ae2c42d171cb_71519f0f-bbd6-4c62-82f8-89f5e9f0f26b.html,,,,,, "Sulfonic acids, petroleum, sodium salts",68608-26-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e95841b7-8d0f-4bb5-9140-f4e21c44e973/documents/IUC5-e4f97147-c201-4509-92c7-ae2c42d171cb_71519f0f-bbd6-4c62-82f8-89f5e9f0f26b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Sulfonic acids, petroleum, sodium salts",68608-26-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e95841b7-8d0f-4bb5-9140-f4e21c44e973/documents/IUC5-e4f97147-c201-4509-92c7-ae2c42d171cb_71519f0f-bbd6-4c62-82f8-89f5e9f0f26b.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Sulfonic acids, petroleum, sodium salts",68608-26-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e95841b7-8d0f-4bb5-9140-f4e21c44e973/documents/IUC5-e4f97147-c201-4509-92c7-ae2c42d171cb_71519f0f-bbd6-4c62-82f8-89f5e9f0f26b.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,49.5 mg/m3,,rat "Sulfonic acids, petroleum, sodium salts",68608-26-4,"Acute mammalian toxicity in rats, exposed by the oral gavage, inhalation and dermal routes ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e95841b7-8d0f-4bb5-9140-f4e21c44e973/documents/IUC5-378482ca-3351-4220-95d2-5ae4938aa42d_71519f0f-bbd6-4c62-82f8-89f5e9f0f26b.html,,,,,, "Sulfonic acids, petroleum, sodium salts",68608-26-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e95841b7-8d0f-4bb5-9140-f4e21c44e973/documents/IUC5-378482ca-3351-4220-95d2-5ae4938aa42d_71519f0f-bbd6-4c62-82f8-89f5e9f0f26b.html,,oral,LD50,"5,000 mg/kg bw",, "Sulfonic acids, petroleum, sodium salts",68608-26-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e95841b7-8d0f-4bb5-9140-f4e21c44e973/documents/IUC5-378482ca-3351-4220-95d2-5ae4938aa42d_71519f0f-bbd6-4c62-82f8-89f5e9f0f26b.html,,dermal,LD50,"5,000 mg/kg bw",, "Sulfonic acids, petroleum, sodium salts",68608-26-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e95841b7-8d0f-4bb5-9140-f4e21c44e973/documents/IUC5-378482ca-3351-4220-95d2-5ae4938aa42d_71519f0f-bbd6-4c62-82f8-89f5e9f0f26b.html,,inhalation,LC50,1.9 mg/m3,, "Sulfonic acids, shale-oil, sodium salts",93686-18-1," The acute oral median lethal dose (LD50) of sulfonic acids, shale oil, sodium salts, in the female Wistar strain rat was estimated to bе greater than 2000 mg/kg body weight. LD50 (rat): > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a30d4b0-c779-449e-b5d1-1202580cc958/documents/8d0dd412-1924-443e-aebc-9daa320fe6c7_e7ce36d7-db7d-4fbe-a7a5-a29af9facf3c.html,,,,,, "Sulfonic acids, shale-oil, sodium salts",93686-18-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a30d4b0-c779-449e-b5d1-1202580cc958/documents/8d0dd412-1924-443e-aebc-9daa320fe6c7_e7ce36d7-db7d-4fbe-a7a5-a29af9facf3c.html,,oral,LD50,"2,000 mg/kg bw",, "Sulfuric acid, mono-C12-14-alkyl esters, magnesium salts",90583-23-6," No data on repeated dose toxicity are available for the target substance sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, magnesium salts (CAS 90583-23-6). Therefore, read-across from structural analogue substances has been applied. Oral and dermal repeated dose toxicity: NOAEL = 488 mg/kg bw/day Read-across of key information from source substance sulfuric acid, mono-C12-15-alkyl esters, sodium salts (CAS 68890-70-0) supported by additional studies performed with various structural analogue substances. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cacd525f-4e64-4dfd-b9a2-5db126fafc5c/documents/d63fe268-dd4a-4a96-a517-f985c3ce1f32_da57ee32-4fac-4bec-b7ae-5e5e51adab74.html,,,,,, "Sulfuric acid, mono-C12-14-alkyl esters, magnesium salts",90583-23-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cacd525f-4e64-4dfd-b9a2-5db126fafc5c/documents/d63fe268-dd4a-4a96-a517-f985c3ce1f32_da57ee32-4fac-4bec-b7ae-5e5e51adab74.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,488 mg/kg bw/day,,rat "Sulfuric acid, mono-C12-14-alkyl esters, magnesium salts",90583-23-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cacd525f-4e64-4dfd-b9a2-5db126fafc5c/documents/d63fe268-dd4a-4a96-a517-f985c3ce1f32_da57ee32-4fac-4bec-b7ae-5e5e51adab74.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,,mouse "Sulfuric acid, mono-C12-14-alkyl esters, magnesium salts",90583-23-6," No data are available for the target substance sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, magnesium salts (CAS 90583-23-6). Therefore, read-across from structural analogue substances has been applied. Oral (EU Method B.1bis): LD50 (rat, m/f) > 500 <= 2000 mg/kg bw Read-across from structural analogue source substances accounted for in a Weight-of-Evidence approach: sulfuric acid, mono-C12-14-alkyl esters, sodium salts (CAS 85586-07-8), sodium tetradecyl sulfate (CAS 68585-47-7), sodium dodecyl sulfate (CAS 151-21-3), and sulfuric acid, mono-C12-13-alkyl esters, sodium salts (CAS 91783-23-2) Acute toxicity by inhalation was not tested according to Regulation (EC) No. 1907/2006, Annex VIII, Section 8.5, Column 2. Dermal (OECD 402): LD50 (rat, m/f) > 2000 mg/kg bw (limit test) Read-across from structural analogue source substance sodium octyl sulfate (CAS 142-31-4), supported by additional studies with various structural analogue substances ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cacd525f-4e64-4dfd-b9a2-5db126fafc5c/documents/8092870e-a92e-408c-95b7-951e891eff8e_da57ee32-4fac-4bec-b7ae-5e5e51adab74.html,,,,,, "Sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, potassium salts",1268005-68-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/309fd217-f87c-4548-bc08-f83a0efc2d21/documents/c03268c9-7617-44c1-a8fe-608c19d41491_1d672618-2c61-4a95-ae73-890881b7ef2f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,488 mg/kg bw/day,,rat "Sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, potassium salts",1268005-68-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/309fd217-f87c-4548-bc08-f83a0efc2d21/documents/c03268c9-7617-44c1-a8fe-608c19d41491_1d672618-2c61-4a95-ae73-890881b7ef2f.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,,mouse "Sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, potassium salts",1268005-68-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The whole data base is conclusive and of high quality. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The whole data base is conclusive and of high quality. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/309fd217-f87c-4548-bc08-f83a0efc2d21/documents/330c71ca-64ac-43e4-bac4-89764b8adc09_1d672618-2c61-4a95-ae73-890881b7ef2f.html,,,,,, "Sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, potassium salts",1268005-68-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/309fd217-f87c-4548-bc08-f83a0efc2d21/documents/330c71ca-64ac-43e4-bac4-89764b8adc09_1d672618-2c61-4a95-ae73-890881b7ef2f.html,,oral,LD50,"1,800 mg/kg bw",adverse effect observed, "Sulfuric acid, mono-C12-14 (even numbered)-alkyl esters, potassium salts",1268005-68-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/309fd217-f87c-4548-bc08-f83a0efc2d21/documents/330c71ca-64ac-43e4-bac4-89764b8adc09_1d672618-2c61-4a95-ae73-890881b7ef2f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sulfuric acid, mono-C16-18-alkyl esters, sodium salts",68955-20-4,For the whole category of alkyl sulfates (AS) a NOAEL of 488 mg/kg bw/day for oral and dermal exposure was established. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fef06376-2a6e-42c1-bcc4-bc36ff1e3194/documents/IUC5-52ebeb42-9e12-4969-b0d9-af27a5e35f47_9d0ae2d1-38f3-4193-aa5f-6dfe4a143151.html,,,,,, "Sulfuric acid, mono-C16-18-alkyl esters, sodium salts",68955-20-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fef06376-2a6e-42c1-bcc4-bc36ff1e3194/documents/IUC5-52ebeb42-9e12-4969-b0d9-af27a5e35f47_9d0ae2d1-38f3-4193-aa5f-6dfe4a143151.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,488 mg/kg bw/day,,rat "Sulfuric acid, mono-C16-18-alkyl esters, sodium salts",68955-20-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fef06376-2a6e-42c1-bcc4-bc36ff1e3194/documents/IUC5-52ebeb42-9e12-4969-b0d9-af27a5e35f47_9d0ae2d1-38f3-4193-aa5f-6dfe4a143151.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,,mouse "Sulfuric acid, mono-C16-18-alkyl esters, sodium salts",68955-20-4,"Oral LD50 (OECD guideline 401), rat = 4010 mg/kg bwDermal LD50 (OECD guideline 402), rabbit > 2000 mg/kg bw (limit test) Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fef06376-2a6e-42c1-bcc4-bc36ff1e3194/documents/IUC5-c1de933d-e941-45de-97bf-b0ab13db58c6_9d0ae2d1-38f3-4193-aa5f-6dfe4a143151.html,,,,,, "Sulfuric acid, mono-C16-18-alkyl esters, sodium salts",68955-20-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fef06376-2a6e-42c1-bcc4-bc36ff1e3194/documents/IUC5-c1de933d-e941-45de-97bf-b0ab13db58c6_9d0ae2d1-38f3-4193-aa5f-6dfe4a143151.html,,oral,LD50,"4,010 mg/kg bw",adverse effect observed, "Sulfuric acid, mono-C16-18-alkyl esters, sodium salts",68955-20-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fef06376-2a6e-42c1-bcc4-bc36ff1e3194/documents/IUC5-c1de933d-e941-45de-97bf-b0ab13db58c6_9d0ae2d1-38f3-4193-aa5f-6dfe4a143151.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sulfuric acid, mono-C9-11-alkyl esters, sodium salts",84501-49-5,For the whole category of alkyl sulfates (AS) a NOAEL of 488 mg/kg bw/day for oral and dermal exposure was established. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec2fc263-1798-416f-8e13-5b8229acf314/documents/IUC5-bbb9aa05-d708-45dd-b7b4-0f67b87a9f8d_ffbc9084-88c3-4b11-8f02-aff823dd2908.html,,,,,, "Sulfuric acid, mono-C9-11-alkyl esters, sodium salts",84501-49-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec2fc263-1798-416f-8e13-5b8229acf314/documents/IUC5-bbb9aa05-d708-45dd-b7b4-0f67b87a9f8d_ffbc9084-88c3-4b11-8f02-aff823dd2908.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,488 mg/kg bw/day,,rat "Sulfuric acid, mono-C9-11-alkyl esters, sodium salts",84501-49-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ec2fc263-1798-416f-8e13-5b8229acf314/documents/IUC5-bbb9aa05-d708-45dd-b7b4-0f67b87a9f8d_ffbc9084-88c3-4b11-8f02-aff823dd2908.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,,mouse "Sulfuric acid, mono-C9-11-alkyl esters, sodium salts",84501-49-5,"Oral LD50 (OECD guideline 401), rat = 1200 mg/kg bwDermal LD50 (OECD guideline 402), rabbit >= 2000 mg/kg bw (limit test) Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec2fc263-1798-416f-8e13-5b8229acf314/documents/IUC5-b06a4420-a3a9-4a53-8866-00292f801c00_ffbc9084-88c3-4b11-8f02-aff823dd2908.html,,,,,, "Sulfuric acid, mono-C9-11-alkyl esters, sodium salts",84501-49-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec2fc263-1798-416f-8e13-5b8229acf314/documents/IUC5-b06a4420-a3a9-4a53-8866-00292f801c00_ffbc9084-88c3-4b11-8f02-aff823dd2908.html,,oral,LD50,"1,200 mg/kg bw",adverse effect observed, "Sulfuric acid, mono-C9-11-alkyl esters, sodium salts",84501-49-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec2fc263-1798-416f-8e13-5b8229acf314/documents/IUC5-b06a4420-a3a9-4a53-8866-00292f801c00_ffbc9084-88c3-4b11-8f02-aff823dd2908.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sulfurous acid, lead salt, dibasic",62229-08-7," Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/1a759cfb-fbe2-4d64-8497-a1cf4d0efd1a/documents/1891e42f-b9cc-41db-8803-cc374656f83a_0addb98b-684c-4600-9e61-81351f7a318d.html,,,,,, "Sulfurous acid, lead salt, dibasic",62229-08-7, Inorganic lead compounds do not exhibit toxicity in acute toxicity tests with experimental animals. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a759cfb-fbe2-4d64-8497-a1cf4d0efd1a/documents/IUC5-6799ade1-e88d-4f15-b797-7dbe176cf255_0addb98b-684c-4600-9e61-81351f7a318d.html,,,,,, "Sulfurous acid, lead salt, dibasic",62229-08-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a759cfb-fbe2-4d64-8497-a1cf4d0efd1a/documents/IUC5-6799ade1-e88d-4f15-b797-7dbe176cf255_0addb98b-684c-4600-9e61-81351f7a318d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sulfurous acid, lead salt, dibasic",62229-08-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a759cfb-fbe2-4d64-8497-a1cf4d0efd1a/documents/IUC5-6799ade1-e88d-4f15-b797-7dbe176cf255_0addb98b-684c-4600-9e61-81351f7a318d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Sulfurous acid, lead salt, dibasic",62229-08-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1a759cfb-fbe2-4d64-8497-a1cf4d0efd1a/documents/IUC5-6799ade1-e88d-4f15-b797-7dbe176cf255_0addb98b-684c-4600-9e61-81351f7a318d.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Sulphamidic acid,5329-14-6,"NOAEL oral = 10000 ppm (equivalent to 1000 mg/kg bw/day) in rat. LOAEL oral = 20000 ppm (equivalent to 2000 mg/kg bw/day) in rat. The selected key study findings are supported by two additional studies with sulphamidic acid and two more studies with ammonium sulphamate, all showing comparable results and describing similar symptoms at elevated doses. Thus, the quality of the database is considered very good. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/693803fd-cfb8-495f-b930-0d8435191e4d/documents/9d79880b-70a5-4db0-8342-3ea8301f75e0_02566327-d396-44c4-a510-0172538c8352.html,,,,,, Sulphamidic acid,5329-14-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/693803fd-cfb8-495f-b930-0d8435191e4d/documents/9d79880b-70a5-4db0-8342-3ea8301f75e0_02566327-d396-44c4-a510-0172538c8352.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Sulphamidic acid,5329-14-6,LD50 oral: 2065 mg/kg in rat LD50 dermal: >2000 mg/kg in rat ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/693803fd-cfb8-495f-b930-0d8435191e4d/documents/ead436ff-ac5e-4009-b8dd-e2f327005505_02566327-d396-44c4-a510-0172538c8352.html,,,,,, Sulphamidic acid,5329-14-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/693803fd-cfb8-495f-b930-0d8435191e4d/documents/ead436ff-ac5e-4009-b8dd-e2f327005505_02566327-d396-44c4-a510-0172538c8352.html,,oral,LD50,"2,065 mg/kg bw",no adverse effect observed, Sulphamidic acid,5329-14-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/693803fd-cfb8-495f-b930-0d8435191e4d/documents/ead436ff-ac5e-4009-b8dd-e2f327005505_02566327-d396-44c4-a510-0172538c8352.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Sulphoacetic acid,123-43-3, Acute oral toxicity study was done in rat using sulfoacetic acid (123-43-3). LD50 was considered to be 3160 mg/kg body weight. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54f7cf3a-8556-4be7-9aeb-6e47ca979f83/documents/a691341a-c736-47f9-ac70-61ceccedb264_4b3ccb1a-185f-4df5-8246-0bbcb93e1bab.html,,,,,, Sulphoacetic acid,123-43-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54f7cf3a-8556-4be7-9aeb-6e47ca979f83/documents/a691341a-c736-47f9-ac70-61ceccedb264_4b3ccb1a-185f-4df5-8246-0bbcb93e1bab.html,,oral,LD50,"3,160 mg/kg bw",no adverse effect observed, Sulphur dioxide,7446-09-5,"Data on the effects in animals following inhalation exposure towards sulfur dioxide were merely included for completeness reasons. Since adequate human data are available the animal data will not be taken forward for human health risk assessment.Data from experiments in various animal species with acute or short-term exposure support the finding in humans, in that sulfur dioxide causes irritation to the upper respiratory tract and eyes. Furthermore, reduced respiratory defence mechanisms against bacterial infections, changes in lipid metabolism, and changes in liver and blood enzyme activities are also reported. However, animals were exposed to very high sulfur dioxide concentrations (up to 267 mg/m³ in sub-chronic studies or >1000 mg/m³ in acute studies). The exposure levels in long-term animal studies on guinea pigs, monkeys, and dogs were lower (0.35 up to 133 mg/m³) than in short-term animal studies. However, no concentration-response relationships could be established because data were too limited to be useful for quantitative risk assessment. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/737e458c-e66d-420a-8e79-7df6373fadad/documents/IUC5-ef6c5e54-a9be-4fbe-8170-7b433ae0bf25_e97011c9-070c-4be7-8ede-219534b796d6.html,,,,,, Sulphur dioxide,7446-09-5,"The acute toxic action of sulfur dioxide is characterized by rapid onset of depression of the respiratory rate and by tissue changes in the upper respiratory tract that penetrate to deeper regions as concentrations rise. In persons exposed to high sulfur dioxide concentrations either accidentally or in former times at workplaces, burning of eyes, nose and throat, rhinorrhea, tearing of eyes, dyspnoea, chest tightness, cough, and injury of the cornea have been observed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/737e458c-e66d-420a-8e79-7df6373fadad/documents/IUC5-d4f02291-1e73-4232-8af6-bafb7b09e217_e97011c9-070c-4be7-8ede-219534b796d6.html,,,,,, Sulphur dioxide,7446-09-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/737e458c-e66d-420a-8e79-7df6373fadad/documents/IUC5-d4f02291-1e73-4232-8af6-bafb7b09e217_e97011c9-070c-4be7-8ede-219534b796d6.html,,inhalation,LC50,"2,528.5 mg/m3",, Sulphur hexafluoride,2551-62-4," The available 90-day study did not result in any treatment-related changes in the parameters tested. Therefore, the concentration level of 120870 mg/m3 was considered to be the No-Observed-Adverse-Effect-Concentration (NOAEC) for systemic and local toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39e62048-7531-4a7b-9ee5-8ec293249723/documents/IUC5-742cd646-9951-4c5e-aab6-80764e7b4969_6d5866b9-f944-4077-a8b2-f9a3fc3b6294.html,,,,,, Sulphur hexafluoride,2551-62-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39e62048-7531-4a7b-9ee5-8ec293249723/documents/IUC5-742cd646-9951-4c5e-aab6-80764e7b4969_6d5866b9-f944-4077-a8b2-f9a3fc3b6294.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"120,870 mg/m3",,rat Sulphur hexafluoride,2551-62-4,"Available animal and human data indicate that acute toxicity of SF6 is very low. Although most available animal acute toxicity studies have not been performed in accordance with currently regulatory guidelines, based on a weight of evidence approach in combination with available human studies they are considered to be sufficient to cover this endpoint.In the limited acute inhalation studies conducted with rats which were exposed up to 80% SF6, no deaths or adverse effects clearly attributable to SF6 were recorded. Also no mortalities or adverse effects were noted in a GLP-compliant 28-day repeated dose toxicity study with rats, exposed to 302687 mg/m3 SF6 for 6 hours daily. No significant adverse effects were recorded in several studies in humans acutely exposed to an atmosphere containing up to 80% SF6, although slight anaesthetic effects and slight signs of discomfort, such as coolness in the upper respiratory tract and the occurrence of voice deepening (which is likely due to the higher density of SF6 in comparison with air), were observed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39e62048-7531-4a7b-9ee5-8ec293249723/documents/IUC5-9944cfca-83be-4c18-8caa-3dde2fb99d22_6d5866b9-f944-4077-a8b2-f9a3fc3b6294.html,,,,,, Sulphur trioxide,7446-11-9," A large number of repeated dose inhalation studies have been performed with sulphuric acid.  Sulphur trioxide is regarded as the anhydride of sulphuric acid. Sulphur trioxide reacts rapidly with moisture in the atmosphere and respiratory tract to form sulphuric acid, therefore these studies are relevant to sulphur trioxide. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6fbe9965-9d8f-4d4e-9d88-d6d48fb462cc/documents/IUC5-54c77a28-ef91-4d80-9bb7-d2350250dd6a_fae4dcb1-9b03-4ada-9ba1-f77163c97993.html,,,,,, Sulphur trioxide,7446-11-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6fbe9965-9d8f-4d4e-9d88-d6d48fb462cc/documents/IUC5-54c77a28-ef91-4d80-9bb7-d2350250dd6a_fae4dcb1-9b03-4ada-9ba1-f77163c97993.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,0.3 mg/m3,, Sulphur trioxide,7446-11-9," No acute toxicity studies are available for sulphur trioxide.  A study of acute oral toxicity is available for sulphuric acid.  A number of non-standard acute inhalation studies are available; studies were performed in various species and using various exposure times.  In three of the studies, sulphuric acid aerosols were generated by mixing sulphur trioxide and humid air.  Studies performed using sulphuric acid are therefore relevant to sulphur trioxide. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fbe9965-9d8f-4d4e-9d88-d6d48fb462cc/documents/IUC5-1ccdcda2-645a-466b-9332-f596cebbe839_fae4dcb1-9b03-4ada-9ba1-f77163c97993.html,,,,,, Sulphur trioxide,7446-11-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fbe9965-9d8f-4d4e-9d88-d6d48fb462cc/documents/IUC5-1ccdcda2-645a-466b-9332-f596cebbe839_fae4dcb1-9b03-4ada-9ba1-f77163c97993.html,,oral,LD50,"2,140 mg/kg bw",, Sulphur trioxide,7446-11-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6fbe9965-9d8f-4d4e-9d88-d6d48fb462cc/documents/IUC5-1ccdcda2-645a-466b-9332-f596cebbe839_fae4dcb1-9b03-4ada-9ba1-f77163c97993.html,,inhalation,LC50,375 mg/m3,, "Sulphuric acid, compound with graphite",12777-87-6,"From a subchronic toxicity study conducted according to OECD TG 408 with SAT Graphite in Crl:WI(Han) rats, oral gavage administration up to a dose level of 1000 mg/kg bw/day over a period of 90 days, no toxicologically relevant effects were observed. Therefore, the no observed adverse effect level (NOAEL) was considered to be >1000 mg/kg bw/day. There is no study data available with SAT Graphite for the inhalation and dermal route. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/99b3af60-3d55-4844-8750-a9598f76d813/documents/221333cc-790a-4982-9d21-6c033b10ecc1_abed4f69-36d5-4862-b0bd-ac6dbf58d991.html,,,,,, "Sulphuric acid, compound with graphite",12777-87-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/99b3af60-3d55-4844-8750-a9598f76d813/documents/221333cc-790a-4982-9d21-6c033b10ecc1_abed4f69-36d5-4862-b0bd-ac6dbf58d991.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Sulphuric acid, compound with graphite",12777-87-6,"In an acute oral toxicity study performed according to OECD TG 423 (acute toxic class method) in WISTAR Crl: WI (Han) rats, the acute oral LD50 was >2000 mg/kg bw. In an acute dermal toxicity study (OECD TG 402) in Crl:WI(Han) rats with Expandable Natural Graphite (purity >93%), the acute dermal LD50 in rats was determined to be > 2000 mg/kg body weight. In pre-test trials for an acute inhalation toxicity limit test, the test substance could not be aerosolized. The overall results of the pre-test trials indicate that the physical and chemical properties of the test substance prevented the achievement of the required testing concentration.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99b3af60-3d55-4844-8750-a9598f76d813/documents/b2ace872-4a5c-4a34-a8e0-0a821b8c990c_abed4f69-36d5-4862-b0bd-ac6dbf58d991.html,,,,,, "Sulphuric acid, compound with graphite",12777-87-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99b3af60-3d55-4844-8750-a9598f76d813/documents/b2ace872-4a5c-4a34-a8e0-0a821b8c990c_abed4f69-36d5-4862-b0bd-ac6dbf58d991.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Sulphuric acid, compound with graphite",12777-87-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99b3af60-3d55-4844-8750-a9598f76d813/documents/b2ace872-4a5c-4a34-a8e0-0a821b8c990c_abed4f69-36d5-4862-b0bd-ac6dbf58d991.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Sulpiride,15676-16-1, No adverse effects were observed after subacute and subchronic levosulpiride administration. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c770589-dbbf-4dfc-a0f3-d9162b85bb4d/documents/38853ee9-8f0e-4243-aea7-08107081dc64_d18b246e-13d7-423f-a045-5da4c757759e.html,,,,,, Sulpiride,15676-16-1, LD50 values for several animal species are available in the scientific literature. Those values are almost all higher than 2000 mg/kg (a LD50 of 1700 mg/kg bw also is reported for mouse). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c770589-dbbf-4dfc-a0f3-d9162b85bb4d/documents/f5e546da-2f6c-49af-af02-04fc44c69d51_d18b246e-13d7-423f-a045-5da4c757759e.html,,,,,, Sulpiride,15676-16-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c770589-dbbf-4dfc-a0f3-d9162b85bb4d/documents/f5e546da-2f6c-49af-af02-04fc44c69d51_d18b246e-13d7-423f-a045-5da4c757759e.html,,oral,LD50,"6,000 mg/kg bw",adverse effect observed, Superphosphates,8011-76-5," No reliable study with single superphosphate is present. However, an expert statement shows no adverse effects are expected for SSP, considering both the values derived for safe use of the relevant ions and the results of a reliable OECD 422 study with the substance’s analogue TSP. The read-across rationale and the expert statement are included in both IUCLID and the CSR. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18d4bd53-d0f5-40ca-9465-9ff757b45ca4/documents/IUC5-69cd1721-4983-4adc-b106-d2d49a5c027d_36e70fb6-7d4e-41d9-84cc-dd6931e06542.html,,,,,, Superphosphates,8011-76-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18d4bd53-d0f5-40ca-9465-9ff757b45ca4/documents/IUC5-69cd1721-4983-4adc-b106-d2d49a5c027d_36e70fb6-7d4e-41d9-84cc-dd6931e06542.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Superphosphates,8011-76-5,"No reliable studies with single superphosphate are present. Based on reliable studies with diammonium hydrogenorthophosphate for acute oral, dermal and inhalation exposure to rats, the oral and dermal LD50 is >2000 mg/kg bw and the LC50 is > 5 mg/L. This is confirmed by acute oral and dermal toxicity studies with calcium (bisdihydrogenorthophosphate). The read-across rationale can be found in the category approach document attached in the target record and is fully incorporated in the CSR. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18d4bd53-d0f5-40ca-9465-9ff757b45ca4/documents/IUC5-1847097a-3ca8-428b-893b-784215e70723_36e70fb6-7d4e-41d9-84cc-dd6931e06542.html,,,,,, Superphosphates,8011-76-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18d4bd53-d0f5-40ca-9465-9ff757b45ca4/documents/IUC5-1847097a-3ca8-428b-893b-784215e70723_36e70fb6-7d4e-41d9-84cc-dd6931e06542.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Superphosphates,8011-76-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18d4bd53-d0f5-40ca-9465-9ff757b45ca4/documents/IUC5-1847097a-3ca8-428b-893b-784215e70723_36e70fb6-7d4e-41d9-84cc-dd6931e06542.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Superphosphates,8011-76-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18d4bd53-d0f5-40ca-9465-9ff757b45ca4/documents/IUC5-1847097a-3ca8-428b-893b-784215e70723_36e70fb6-7d4e-41d9-84cc-dd6931e06542.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Superphosphates, concd.",65996-95-4," Based on a reliable oral OECD 422 study with triple superphosphate in rats, local effects were observed in the stomach at the lowest dose tested (250 mg/kg bw/day). Due to systemic effects on the teeth (horizontal banding, possible mineralisation process), at the mid dose the systemic NOAEL is determined to be 250 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2a880bf-f92d-4938-991c-173020bf9b7f/documents/IUC5-ff934366-810d-43fc-ae69-5875615b08e8_3c2a407e-76d7-4d76-84f0-e9541351c5d9.html,,,,,, "Superphosphates, concd.",65996-95-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e2a880bf-f92d-4938-991c-173020bf9b7f/documents/IUC5-ff934366-810d-43fc-ae69-5875615b08e8_3c2a407e-76d7-4d76-84f0-e9541351c5d9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Superphosphates, concd.",65996-95-4," No reliable studies with triple superphosphate are present. Based on reliable studies with diammonium hydrogenorthophosphate for acute oral, dermal and inhalation exposure to rats, the oral and dermal LD50 is >2000 mg/kg bw and the LC50 is > 4.84 mg/L air (analytical). In addition, reliable acute oral, inhalation and dermal toxicity studies with calcium bis(dihydrogenorthophosphate) confirm these findings. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2a880bf-f92d-4938-991c-173020bf9b7f/documents/IUC5-3ea2dca9-740c-4b43-9509-e08dd321620e_3c2a407e-76d7-4d76-84f0-e9541351c5d9.html,,,,,, "Superphosphates, concd.",65996-95-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2a880bf-f92d-4938-991c-173020bf9b7f/documents/IUC5-3ea2dca9-740c-4b43-9509-e08dd321620e_3c2a407e-76d7-4d76-84f0-e9541351c5d9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Superphosphates, concd.",65996-95-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2a880bf-f92d-4938-991c-173020bf9b7f/documents/IUC5-3ea2dca9-740c-4b43-9509-e08dd321620e_3c2a407e-76d7-4d76-84f0-e9541351c5d9.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Superphosphates, concd.",65996-95-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e2a880bf-f92d-4938-991c-173020bf9b7f/documents/IUC5-3ea2dca9-740c-4b43-9509-e08dd321620e_3c2a407e-76d7-4d76-84f0-e9541351c5d9.html,,inhalation,LC50,"4,840 mg/m3",no adverse effect observed, "Synthetic resin, a reaction product of 4,4'-bis(N-maleimido)diphenylmethane with 3-aminobenzoic acid hydrazide",98725-11-2," - study conducted according to OECD guideline 401, GLP, 5 female and male Wistar rats were exposed to 2000 mg/kg bw of 1,1'-(methylenedi-p-phenylene)bismaleimide applied as a single dose via gavage and observed for 15 days, not mortality, no clinical signs detected, LD50 > 2000 mg/kg bw, read-across - study conducted according to OECD guideline 401, GLP, 5 female and male Wistar rats per dose group were exposed to 200, 800 and 2000 mg/kg bw of 3 -aminobenzohydrazide applied as a single dose via gavage and observed for 15 days, base on clinical sings and premature mortality the LD50 was determined to be 1390.97 mg/kg bw (adjusted to the amount of 3-aminobenzohydrazide present in the final product: LD50 = 9151.12 mg/kg bw), read-across ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/140b754b-ebce-47ba-b79f-a1b4b29deab8/documents/3ea803b0-7422-43c8-8e63-df401dc20086_bc625848-7df7-4224-abfb-f5b1217e32e1.html,,,,,, "Synthetic resin, a reaction product of 4,4'-bis(N-maleimido)diphenylmethane with 3-aminobenzoic acid hydrazide",98725-11-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/140b754b-ebce-47ba-b79f-a1b4b29deab8/documents/3ea803b0-7422-43c8-8e63-df401dc20086_bc625848-7df7-4224-abfb-f5b1217e32e1.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Synthetic resin, a reaction product of 4,4'-bis(N-maleimido)diphenylmethane with 3-aminobenzoic acid hydrazide",98725-11-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/140b754b-ebce-47ba-b79f-a1b4b29deab8/documents/3ea803b0-7422-43c8-8e63-df401dc20086_bc625848-7df7-4224-abfb-f5b1217e32e1.html,,inhalation,LC50,515 mg/m3,adverse effect observed, "Tall oil, compd. with diethanolamine",68092-28-4,"REPEATED DOSE TOXICITY: ORAL28 Day NOEL for tall oil 1000 ppm male and female Sprague-Dawley rats28 Day NOAEL for tall oil, compound with ethanolamine 300 mg/kg male and female Wistar rats90 Day LOAEL for diethanolamine 20 mg/kg in F344 rats90 Day LOAEL for diethanolamine 123 mg/kg in B6C3F1 miceREPEATED DOSE TOXICITY: DERMAL90 Day LOAEL for diethanolamine 32 mg/kg male and female F344 rats90 Day LOAEL for diethanolamine 80 mg/kg male B6C3F1 mice Both the key and supporting studies were conducted using a procedure equivalent to the standardised guideline OECD 411 under GLP conditions and as such were awarded a reliability score of 2 in accordance with the criteria set forth by Klimisch (1997). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a565f8ba-53ce-435e-861b-653fb9eb6fd7/documents/IUC5-235938b8-88dc-4ca9-9392-0fc9e89ffc85_9a228da5-1d0f-4905-ac5e-7f182ed85be5.html,,,,,, "Tall oil, compd. with diethanolamine",68092-28-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a565f8ba-53ce-435e-861b-653fb9eb6fd7/documents/IUC5-235938b8-88dc-4ca9-9392-0fc9e89ffc85_9a228da5-1d0f-4905-ac5e-7f182ed85be5.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,20 mg/kg bw/day,,rat "Tall oil, compd. with diethanolamine",68092-28-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a565f8ba-53ce-435e-861b-653fb9eb6fd7/documents/IUC5-235938b8-88dc-4ca9-9392-0fc9e89ffc85_9a228da5-1d0f-4905-ac5e-7f182ed85be5.html,Sub-chronic toxicity – systemic effects,dermal,LOAEL,32 mg/kg bw/day,,rat "Tall oil, compd. with diethanolamine",68092-28-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a565f8ba-53ce-435e-861b-653fb9eb6fd7/documents/IUC5-235938b8-88dc-4ca9-9392-0fc9e89ffc85_9a228da5-1d0f-4905-ac5e-7f182ed85be5.html,Repeated dose toxicity – local effects,dermal,LOAEL,32 ,adverse effect observed,rat "Tall oil, compd. with diethanolamine",68092-28-4,ACUTE TOXICITY: ORAL - LD50 >2000 mg/kg bodyweight in female Wistar strain rats   The key study was conducted under GLP conditions in accordance with the standardised guidelines OECD 420 and EU Method B.1 bis. It was assigned a reliability score of 1 in accordance with the criteria detailed by Klimisch (1997). ACUTE TOXICITY: DERMAL - LD50 >2000 mg/kg bw in male and female Wistar rats The key study was conducted under GLP conditions in accordance with the standardised guidelines OECD 402 and EU Method B.3. It was assigned a reliability score of 1 in accordance with the criteria detailed by Klimisch (1997). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a565f8ba-53ce-435e-861b-653fb9eb6fd7/documents/IUC5-b578f3ed-42ff-42bd-8c09-a3fbd8e124a2_9a228da5-1d0f-4905-ac5e-7f182ed85be5.html,,,,,, "Tall oil, compd. with ethanolamine",68002-54-0,REPEATED DOSE TOXICITY: ORALNOAEL 300 mg/kg/day for male and female Wistar rats ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9361d292-371f-41ad-8375-6f8f9676fb2a/documents/IUC5-79592925-c70e-4102-b82c-ecb51b15bcbc_20330cc8-352f-487e-b288-aed2abc2f6ca.html,,,,,, "Tall oil, compd. with ethanolamine",68002-54-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9361d292-371f-41ad-8375-6f8f9676fb2a/documents/IUC5-79592925-c70e-4102-b82c-ecb51b15bcbc_20330cc8-352f-487e-b288-aed2abc2f6ca.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Tall oil, compd. with ethanolamine",68002-54-0,ACUTE TOXICITY: ORAL- LD50 >2000 mg/kg bodyweight to female Wistar strain ratsACUTE TOXICITY: DERMAL- LD50 of crude tall oil >2000 mg/kg bw in male and female Sprague-Dawley rats- LD50 of ethanolamine in the New Zealand White rabbit was 2.46 mL/kg in males and 2.83 mL/kg in females ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9361d292-371f-41ad-8375-6f8f9676fb2a/documents/IUC5-df02d435-305a-404d-b9c6-10969aa51687_20330cc8-352f-487e-b288-aed2abc2f6ca.html,,,,,, "Tall oil, compd. with triethanolamine",68092-29-5, Based on the available data the NOAEL for repeated dose toxicity is 80 mg/kg. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8343b9c1-012e-4ca9-94b7-82766e628d8f/documents/53320671-0f60-43c8-ae3c-c986df8b81d5_0d564762-a745-4ec8-b778-7cfd249c4fd7.html,,,,,, "Tall oil, compd. with triethanolamine",68092-29-5, Acute Oral Under the conditions of this study the estimated acute oral LD50 for male and female rats treated with the test material was determined to be greater than 10.0 g/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8343b9c1-012e-4ca9-94b7-82766e628d8f/documents/17565d1f-a186-40e3-9b04-b162d6559fd1_0d564762-a745-4ec8-b778-7cfd249c4fd7.html,,,,,, "Tall oil, compd. with triethanolamine",68092-29-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8343b9c1-012e-4ca9-94b7-82766e628d8f/documents/17565d1f-a186-40e3-9b04-b162d6559fd1_0d564762-a745-4ec8-b778-7cfd249c4fd7.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Tall oil, maleated",68152-93-2,"Under the experimental conditions of an OECD 422 study with 35 days exposure to males and >50 days exposure to females, the daily oral (gavage) administration of the test item, EnvaMul 600, to the rat during pre-mating (males and females), during pregnancy and lactation (females) at doses of 100, 200 and 400 mg/kg/day induced no parental, reproduction or developmental toxicity. Based on these results, a parental, reproduction and developmental No Observed Adverse Effect Level (NOAEL) of at least 400 mg/kg was derived. In addition a subchronic oral toxicity study with rats was performed, according to OECD TG 408 protocol with doses of 0, 100, 300 and 1000 Mg/kg bw/d, respectively. The systemic NOAEL was set conservatively to 300 mg/kg bw/d as the centrilobular hepatocellular hypertrophy in combination with the multifocal hepatocellular necrosis in a single male at 1000 mg/kg/day was considered adverse. However, for local effect a NOAEL of 100 mg/kg bw/d based on irritating effects to the gastrointestinanl tract at 300 and 1000 mg/kg bw/d was set. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/085d22c2-3c22-418f-b90c-b3394d25fee8/documents/5539ba69-cda4-40cd-a115-a1fbcbfca969_729782b0-b21c-455d-9652-3548a94d4009.html,,,,,, "Tall oil, maleated",68152-93-2,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/085d22c2-3c22-418f-b90c-b3394d25fee8/documents/5539ba69-cda4-40cd-a115-a1fbcbfca969_729782b0-b21c-455d-9652-3548a94d4009.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Tall oil, maleated",68152-93-2," Based on the experimental study results, the acute oral LD50 in rats of the test item, Tall Oil, Maleated (EnvaMul™ 600) was found to be greater than 2000 mg/kg. Therefore, the test item is considered not to present a significant acute toxic risk if swallowed. Acute inhalation toxicity study not conducted as exposure is not likely to occur. The dermal LD50 value of EnvaMul 600 in Wistar rats was established to exceed 2000 mg/kg body weight. Based on these results, EnvaMul 600 does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2015) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/085d22c2-3c22-418f-b90c-b3394d25fee8/documents/5c676ca5-8f45-422e-8f0f-f819f606873b_729782b0-b21c-455d-9652-3548a94d4009.html,,,,,, "Tall oil, maleated",68152-93-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/085d22c2-3c22-418f-b90c-b3394d25fee8/documents/5c676ca5-8f45-422e-8f0f-f819f606873b_729782b0-b21c-455d-9652-3548a94d4009.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tall oil, maleated",68152-93-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/085d22c2-3c22-418f-b90c-b3394d25fee8/documents/5c676ca5-8f45-422e-8f0f-f819f606873b_729782b0-b21c-455d-9652-3548a94d4009.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tall oil, polymd., oxidized",68815-17-8," Based on available data for groups of Crude Tall Oil constituents, for Tall Oil, polymd., oxidized a conservative 2-year NOAEL of >200 mg/kg/d is set for the oral route (see read across justification report) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51337258-13fb-4954-aea3-7a3ec0a64933/documents/1f4867eb-3554-492f-812a-ded98405e444_f65de91d-2d87-4a19-bba0-3bb1f03931d5.html,,,,,, "Tall oil, polymd., oxidized",68815-17-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/51337258-13fb-4954-aea3-7a3ec0a64933/documents/1f4867eb-3554-492f-812a-ded98405e444_f65de91d-2d87-4a19-bba0-3bb1f03931d5.html,Chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Tall oil, polymd., oxidized",68815-17-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51337258-13fb-4954-aea3-7a3ec0a64933/documents/6b1615fe-5f95-4e21-a334-08e70786b628_f65de91d-2d87-4a19-bba0-3bb1f03931d5.html,,oral,LD50,"5,000 mg/kg bw",, "Tall oil, polymd., oxidized",68815-17-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51337258-13fb-4954-aea3-7a3ec0a64933/documents/6b1615fe-5f95-4e21-a334-08e70786b628_f65de91d-2d87-4a19-bba0-3bb1f03931d5.html,,dermal,LD50,"2,000 mg/kg bw",, "Tall oil, potassium salt",68647-71-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/040262cb-850a-4369-9265-74ba208f0034/documents/4cdc3c75-160e-4459-a6c8-b3bbef2f7720_ce4d1611-d316-4b63-a6f1-d3ecfc5d115d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Tall oil, potassium salt",68647-71-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/040262cb-850a-4369-9265-74ba208f0034/documents/801f75cf-0c5a-4de6-a8aa-5c473adc5eec_ce4d1611-d316-4b63-a6f1-d3ecfc5d115d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tall oil, potassium salt",68647-71-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/040262cb-850a-4369-9265-74ba208f0034/documents/801f75cf-0c5a-4de6-a8aa-5c473adc5eec_ce4d1611-d316-4b63-a6f1-d3ecfc5d115d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tall oil, reaction products with diethylenetriamine",68140-14-7, This endpoint is addressed based on read across to repeated dose oral toxicity data for the major components (AAI_DETA and Rosin) of the submission substance DTO_DETA. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b52a22e-3d53-43aa-8394-a756c66e09a5/documents/13cb688e-5964-4f02-ad44-17cc4590e22d_c4de6c73-60fa-4a35-8148-d2482e4ba967.html,,,,,, "Tall oil, reaction products with diethylenetriamine",68140-14-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b52a22e-3d53-43aa-8394-a756c66e09a5/documents/13cb688e-5964-4f02-ad44-17cc4590e22d_c4de6c73-60fa-4a35-8148-d2482e4ba967.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat "Tall oil, reaction products with diethylenetriamine",68140-14-7, Acute oral toxicity data are available for the submission substance (DTO_DETA) supported by read-across data on the components reaction products of AAI_DETA and rosins. VII of the REACH Regulation as the submission substance is classified as a skin corrosive. No acute inhalation toxicity data are available on the submission substance; data are not required according to Column 2 of Annex No acute dermal toxicity data are available on the submission substance; data are not required according to Column 2 of Annex VII of the REACH Regulation as the submission substance is classified as a skin corrosive. Read-across data are available for the component rosins. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b52a22e-3d53-43aa-8394-a756c66e09a5/documents/507866af-5835-4e45-bab4-ad8a123e2fc1_c4de6c73-60fa-4a35-8148-d2482e4ba967.html,,,,,, "Tall oil, reaction products with diethylenetriamine",68140-14-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b52a22e-3d53-43aa-8394-a756c66e09a5/documents/507866af-5835-4e45-bab4-ad8a123e2fc1_c4de6c73-60fa-4a35-8148-d2482e4ba967.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tall oil, sodium salt",65997-01-5," No repeated dose toxicity data are available for the registration substance therefore this endpoint is addressed by a weight of evidence approach for relevant groups of constituents present in the substance. In a 90-day repeated dose toxicity study (Hepburn et al., 1998) conducted using a protocol equivalent to OECD 408 and in compliance with GLP, administration of phytosterol in the diet of Wistar rats for 90 days did not lead to any adverse effects up to dietary concentrations of 8.1% phytosterol ester (equivalent to 6600 mg/kg bw/day; or 4100 mg/kg bw/day phytosterol). Therefore, the NOAEL from this test was ≥6600 mg/kg bw/day phytosterol ester. In a 90-day oral repeated dose toxicity test (Envigo, 2017) conducted to OECD 408 and in compliance with GLP with tall oil rosin, the NOAEL was concluded to be 5000 ppm (equivalent to a mean achieved dose of 335.2 mg/kg bw/day for males and 401.2 mg/kg bw/day for females) based on reduced body weight gain in the highest dose group. No other adverse effects were observed. In a supporting Combined Repeated Dose Toxicity Study with Reproduction/Developmental Toxicity Screening Test conducted according to OECD 422 and in compliance with GLP for distilled tall oil, the reported NOEL was 1000 ppm (approximately 100 mg/kg bw/day) for both male and female rats. The NOEL was based on effects observed in food consumption, body weight gain, organ weights and changes in clinical biochemistry parameters at 20000 ppm and changes in organ weights and clinical biochemistry parameters at 5000 ppm. No effects were observed at 1000 ppm. In conclusion, under the conditions of this study, the parental NOEL was reported to be 1000 ppm. However, the effects on the liver are considered (by the author the study summary) to be adaptive rather than adverse, and decreased food consumption and weight gain were most likely to be due to palatability of the test diet, rather than toxicity. Therefore, the overall NOAEL for general toxicity was 5000 ppm tall oil (equivalent to approximately 423 mg/kg bw/day for males and 483 mg/kg bw/day for females; the highest dose tested). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25cc7785-7fa1-4539-b925-d85bfbdbafab/documents/aca73a2f-05b4-4e97-9a57-382a7dd8fbd2_4979bda6-3dcf-4b25-b414-852f97c382af.html,,,,,, "Tall oil, sodium salt",65997-01-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/25cc7785-7fa1-4539-b925-d85bfbdbafab/documents/aca73a2f-05b4-4e97-9a57-382a7dd8fbd2_4979bda6-3dcf-4b25-b414-852f97c382af.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,335.2 mg/kg bw/day,,rat "Tall oil, sodium salt",65997-01-5," The key study for acute oral toxicity is a study with the analogue substance Crude Tall Oil (CTO), which was conducted in accordance with OECD TG 423 (acute toxic class method) and in compliance with GLP. No treatment-related effects were observed and the LD50 was concluded to be >5000 mg/kg bw for male and female rats.   The key study for acute dermal toxicity is a study with the analogue substance Crude Tall Oil (CTO), which was conducted in accordance with OECD TG 402 and in compliance with GLP. No treatment-related effects were observed and the LD50 was concluded to be >2000 mg/kg bw for male and female rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25cc7785-7fa1-4539-b925-d85bfbdbafab/documents/6ab4bc71-7515-4233-b12a-8d41dc036568_4979bda6-3dcf-4b25-b414-852f97c382af.html,,,,,, "Tall oil, sodium salt",65997-01-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25cc7785-7fa1-4539-b925-d85bfbdbafab/documents/6ab4bc71-7515-4233-b12a-8d41dc036568_4979bda6-3dcf-4b25-b414-852f97c382af.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Tall oil, sodium salt",65997-01-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25cc7785-7fa1-4539-b925-d85bfbdbafab/documents/6ab4bc71-7515-4233-b12a-8d41dc036568_4979bda6-3dcf-4b25-b414-852f97c382af.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tall-oil pitch,8016-81-7,"No adverse effects were seen in a well-conducted, GLP-compliant, OECD 422 study with ""Tall-oil pitch"". See linked record below for further details. No other key repeated-dose toxicity studies are available for this substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0414384-25fc-467b-aa4d-b844dbb9dd59/documents/0fb78885-4e98-4490-94c3-1fbad4564f56_9f2e0c1b-7ad9-46d7-86b9-46d43b63a435.html,,,,,, Tall-oil pitch,8016-81-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0414384-25fc-467b-aa4d-b844dbb9dd59/documents/0fb78885-4e98-4490-94c3-1fbad4564f56_9f2e0c1b-7ad9-46d7-86b9-46d43b63a435.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat Tall-oil pitch,8016-81-7," An acute oral LD50 value >2000 mg/kg bw in rats was determined in a study conducted in accordance with OECD 425 (up & down method) and in compliance with GLP (inveresk, 2002). There were no mortalities or other treatment-related findings in the study. An acute dermal LD50 >2000 mg/kg bw in rats was determined in a study carried out in accordance with OECD 402 and in compliance with GLP (ARC, 2005a). There were no mortalities, treatment-related systemic effects or local effects during the study. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0414384-25fc-467b-aa4d-b844dbb9dd59/documents/a3fa33a2-fab9-4ee7-8f7c-abae294f57af_9f2e0c1b-7ad9-46d7-86b9-46d43b63a435.html,,,,,, Tall-oil pitch,8016-81-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0414384-25fc-467b-aa4d-b844dbb9dd59/documents/a3fa33a2-fab9-4ee7-8f7c-abae294f57af_9f2e0c1b-7ad9-46d7-86b9-46d43b63a435.html,,oral,LD50,"2,000 mg/kg bw",, Tall-oil pitch,8016-81-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0414384-25fc-467b-aa4d-b844dbb9dd59/documents/a3fa33a2-fab9-4ee7-8f7c-abae294f57af_9f2e0c1b-7ad9-46d7-86b9-46d43b63a435.html,,dermal,LD50,"2,000 mg/kg bw",, "Tallow, lithium salt",68608-50-4,"OECD 422 combined repeat dose and reproductive toxicity screening studies have been conducted on key substances which fall in the definition of the Lithium salts of monocarboxylic acids C14-C22 category. Studies were conducted via oral gavage on lithium myristate, fatty acids C16-18 lithium salts and fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. A study via dietary administration was conducted on lithium 12-hydroxystearate and a dermal study was conducted on fatty acids C18-(unsaturated) lithium salts. The NOAEL was >=500 mg/kg body weight/day for lithium myristate and fatty acids C16-18 lithium salts and was 250 mg/kg body weight/day for fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. The NOAEL for lithium 12-hydroxystearate was 2000 ppm (144 and 161 mg/kg body weight/day for males and females, respectively) based on parental body weights. The NOAEL for fatty acids C18-(unsaturated) lithium salts was 1089.75 mg/kg body weight/day based on systemic effects and 111.25 mg/kg body weight/day based on dermal scores. The results for the tested substances have been read across to the other members of the lithium salts of monocarboxylic acids C14-C22 category. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92a32768-af75-4ac7-ba14-5c1f7ad6bef1/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_9f178dc9-ba4f-45b0-973b-44d814cdd071.html,,,,,, "Tallow, lithium salt",68608-50-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92a32768-af75-4ac7-ba14-5c1f7ad6bef1/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_9f178dc9-ba4f-45b0-973b-44d814cdd071.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,144 mg/kg bw/day,,rat "Tallow, lithium salt",68608-50-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92a32768-af75-4ac7-ba14-5c1f7ad6bef1/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_9f178dc9-ba4f-45b0-973b-44d814cdd071.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,089.75 mg/kg bw/day",,rat "Tallow, lithium salt",68608-50-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/92a32768-af75-4ac7-ba14-5c1f7ad6bef1/documents/7df1a9bb-7a15-4ce8-957a-0f4235181dfd_9f178dc9-ba4f-45b0-973b-44d814cdd071.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.86 mg/cm2,adverse effect observed,rat "Tallow, lithium salt",68608-50-4,"Oral acute toxicity studies in rats were conducted on lithium myristate, fatty acids C18-(unsaturated) lithium salts, lithium docosanoate, and fatty acids C16-18 (even numbered) saturated and C16-20 (even numbered) unsaturated lithium salts. All studies reported no mortality and LD50 values greater than 2000 mg/kg bodyweight. These data have been read across to the other substances in the lithium salts of monocarboxylic acids C14-C22 category. A dermal toxicity study in rats was conducted on fatty acids C18-(unsaturated) lithium salts. The study reported no mortality and LD50 values greater than 2000 mg/kg bodyweight. These data have been read across to the other substances in the lithium salts of monocarboxylic acids C14-C22 category. An estimate of the inhalation dust/mist toxicity by route-to-route extrapolation using conservative standard default values results in an ATE of 10.4 mg/L/4 hours minimum. This value is well above the cut values for classification for acute inhalation toxicity hazard. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92a32768-af75-4ac7-ba14-5c1f7ad6bef1/documents/754e9131-4245-46c3-8876-e6b64b352e18_9f178dc9-ba4f-45b0-973b-44d814cdd071.html,,,,,, "Tallow, lithium salt",68608-50-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92a32768-af75-4ac7-ba14-5c1f7ad6bef1/documents/754e9131-4245-46c3-8876-e6b64b352e18_9f178dc9-ba4f-45b0-973b-44d814cdd071.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Tallow, lithium salt",68608-50-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/92a32768-af75-4ac7-ba14-5c1f7ad6bef1/documents/754e9131-4245-46c3-8876-e6b64b352e18_9f178dc9-ba4f-45b0-973b-44d814cdd071.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Tantalum,7440-25-7," No data regarding the oral exposition is available for tantalum metal (target substance). Thus, available data from tantalum pentachloride and ditantalum pentoxide were used in a read-across approach. In a GLP guideline study according to OECD 422 with tantalum pentachloride, no adverse effects were observed after oral administration of the source substance tantalum pentachloride in male and female Wistar rats at the highest tested dose of 1000 mg/kg bw/day. Based on the results, the NOAEL can be considered to be 1000 mg/kg bw/day. In addition, in a GLP guideline study with the source substance ditantalum pentoxide according to OECD 408, only minimal effects on clinical chemistry parameters were observd, which were not considered toxicologically relevant. Therefore, the NOAEL was considered to be 1000 mg/kg bw/day, i.e. the highest dose tested. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da16d5e4-f80d-4be7-bf3e-bc31577475dc/documents/IUC5-26b0c0f9-4b56-467c-b7dc-569cd76e1eea_645086a7-d171-4743-8947-350c64bfb585.html,,,,,, Tantalum,7440-25-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da16d5e4-f80d-4be7-bf3e-bc31577475dc/documents/IUC5-26b0c0f9-4b56-467c-b7dc-569cd76e1eea_645086a7-d171-4743-8947-350c64bfb585.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tantalum,7440-25-7, The acute toxicity of tantalum was investigated in guideline studies conducted according to OECD 423 respectively 403 addressing the oral and inhalation toxicity of the test material. Tantalum was tested orally at 2000 mg/kg bw and via the inhalation route at 5.18 mg/L without showing any adverse effects. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da16d5e4-f80d-4be7-bf3e-bc31577475dc/documents/IUC5-039c533a-6b3d-4862-a8dc-15c34b7c95bd_645086a7-d171-4743-8947-350c64bfb585.html,,,,,, Tantalum,7440-25-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da16d5e4-f80d-4be7-bf3e-bc31577475dc/documents/IUC5-039c533a-6b3d-4862-a8dc-15c34b7c95bd_645086a7-d171-4743-8947-350c64bfb585.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tantalum,7440-25-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da16d5e4-f80d-4be7-bf3e-bc31577475dc/documents/IUC5-039c533a-6b3d-4862-a8dc-15c34b7c95bd_645086a7-d171-4743-8947-350c64bfb585.html,,inhalation,LC50,"5,180 mg/m3",no adverse effect observed, Tantalum carbide,12070-06-3,"A GLP guideline study according to OECD 422 was conducted. No adverse effects were observed after oral administration of the source substance tantalum pentachloride in male and female Wistar rats at the highest tested dose of 1000 mg/kg bw/day. Based on the results, the NOAEL can be considered to be 1000 mg/kg bw/day. Supporting data was obtained from a non-GLP, non-guideline subacute repeated inhalation toxicity study. The result of this study showed that the inhalation of tantalum pentoxide does not lead to specific changes of the lung tissues and no systemic toxicity was observed. Nevertheless, in some animals haemorrhagic infarcts caused by prolonged dust application were observed. The lesions were attributed to particle effects and are not considered substance specific. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3bbf49e-6363-4348-a7cd-0205aea0a9b2/documents/IUC5-d861bd5a-b233-4fff-9e98-777723498262_061fa67d-62ac-4c97-a70c-77cab87a2f17.html,,,,,, Tantalum carbide,12070-06-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3bbf49e-6363-4348-a7cd-0205aea0a9b2/documents/IUC5-d861bd5a-b233-4fff-9e98-777723498262_061fa67d-62ac-4c97-a70c-77cab87a2f17.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,150 mg/m3,,rat Tantalum carbide,12070-06-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3bbf49e-6363-4348-a7cd-0205aea0a9b2/documents/IUC5-d861bd5a-b233-4fff-9e98-777723498262_061fa67d-62ac-4c97-a70c-77cab87a2f17.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tantalum carbide,12070-06-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f3bbf49e-6363-4348-a7cd-0205aea0a9b2/documents/IUC5-d861bd5a-b233-4fff-9e98-777723498262_061fa67d-62ac-4c97-a70c-77cab87a2f17.html,Repeated dose toxicity – local effects,inhalation,NOAEC,150 mg/m3,no adverse effect observed,rat Tantalum carbide,12070-06-3,"In an acute oral toxicity according to OECD 423 no mortality was observed in rats at concentrations of 2000 mg tantalum/kg bw. In an acute inhalation toxicity study according to OECD 403 conducted with tantalum and tantalum pentoxide no mortality occurred in rats at the highest practicable concentrations (5.18 mg/L and 3.89 mg/L tantalum and tantalum pentoxide, respectively). Tantalum and tantalum pentoxide data are used in read-across approach in the assessment of the acute toxicity of tantalum carbide. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f3bbf49e-6363-4348-a7cd-0205aea0a9b2/documents/IUC5-4c50bf08-b5be-42a6-a093-0f670c1c25c1_061fa67d-62ac-4c97-a70c-77cab87a2f17.html,,,,,, Tantalum pentachloride,7721-01-9,"In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test no adverse effects were found after oral administration of the target substance tantalum pentachloride in male and female Wistar rats. Based on the results, the NOAEL is considered to be 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd977218-84aa-4117-b62b-622da51338ea/documents/IUC5-e65bc702-ca6c-4f05-9d0c-70c1f1a169bc_145fbd47-e7bc-45ba-a7c3-e8fd8b82d8e2.html,,,,,, Tantalum pentachloride,7721-01-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cd977218-84aa-4117-b62b-622da51338ea/documents/IUC5-e65bc702-ca6c-4f05-9d0c-70c1f1a169bc_145fbd47-e7bc-45ba-a7c3-e8fd8b82d8e2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tantalum pentachloride,7721-01-9,For tantalum pentachloride acute toxicity data is available for the oral route. Cochran et al. (1950) published a LD50 of 1900 mg/kg bw in rat for both sexes. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd977218-84aa-4117-b62b-622da51338ea/documents/IUC5-94359906-8d04-4554-b523-14f87235d193_145fbd47-e7bc-45ba-a7c3-e8fd8b82d8e2.html,,,,,, Tantalum pentachloride,7721-01-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd977218-84aa-4117-b62b-622da51338ea/documents/IUC5-94359906-8d04-4554-b523-14f87235d193_145fbd47-e7bc-45ba-a7c3-e8fd8b82d8e2.html,,oral,LD50,"1,900 mg/kg bw",adverse effect observed, "Tar, brown-coal, low-temp.",101316-84-1,"The test substance, Tar, brown-coal, low-temp., was tested for subchronic toxicity using the Method B.26 Sub-Chronic Oral Toxicity Test: Repeated Dose 90-day Oral Toxicity Study in Rodents, Council Regulation (EC) No. 440/2008, Published in O.J. L142, 2008. The values (NOAEL and LOAEL) were established mainly on the basis of changes in red blood cell component, biochemical parameters related to kidney function and histopathology and function of the liver. No other studies on repeated dose toxicity (dermal or inhalation) of the substance are available. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3dcdd1f1-5a75-4684-a998-4d036fc8f487/documents/IUC5-7e166dea-404e-42d0-9d2d-00100f31c4fc_cb6cff88-cd58-477b-a205-69dea46c2949.html,,,,,, "Tar, brown-coal, low-temp.",101316-84-1,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/3dcdd1f1-5a75-4684-a998-4d036fc8f487/documents/IUC5-7e166dea-404e-42d0-9d2d-00100f31c4fc_cb6cff88-cd58-477b-a205-69dea46c2949.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,50 mg/kg bw/day,,rat "Tar, brown-coal, low-temp.",101316-84-1,"The tests of Acute oral toxicity and Acute dermal toxicity were performed according to the following methods: Method B.1 tris: Acute Oral Toxicity - Acute Toxic Class Method, Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008Method B.3 Acute Toxicity (Dermal), Council Regulation (EC) No.440/2008, published in O.J. L 142, 2008Both: GLP studyThe inhalation study was not performed, the exposure is supposed to be insignificant. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3dcdd1f1-5a75-4684-a998-4d036fc8f487/documents/IUC5-ab865acc-dd6e-464d-8198-37b774f76511_cb6cff88-cd58-477b-a205-69dea46c2949.html,,,,,, "Tar, brown-coal, low-temp.",101316-84-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3dcdd1f1-5a75-4684-a998-4d036fc8f487/documents/IUC5-ab865acc-dd6e-464d-8198-37b774f76511_cb6cff88-cd58-477b-a205-69dea46c2949.html,,oral,LD50,"2,000 mg/kg bw",, "Tar, brown-coal, low-temp.",101316-84-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3dcdd1f1-5a75-4684-a998-4d036fc8f487/documents/IUC5-ab865acc-dd6e-464d-8198-37b774f76511_cb6cff88-cd58-477b-a205-69dea46c2949.html,,dermal,LD50,"2,000 mg/kg bw",, "Tar, wood",91722-33-7, The NOAEL was established on the basis of reduced weight gain in femal rats during a subchronic repeadted dose study. No observation of any specific mode of action was made. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34d0bc62-a4f1-4672-ae35-c811792b19b8/documents/IUC5-f19d26d2-154e-48dd-b161-85d41631223d_37ddbaa9-6566-4832-aa11-3b5580d3346d.html,,,,,, "Tar, wood",91722-33-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34d0bc62-a4f1-4672-ae35-c811792b19b8/documents/IUC5-f19d26d2-154e-48dd-b161-85d41631223d_37ddbaa9-6566-4832-aa11-3b5580d3346d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,129 mg/kg bw/day",,rat "Tar, wood",91722-33-7,"The acute oral toxicity of Tarwood was investigated in a study in rats that was performed in accordance with the requirements of the following guidelines and test methods:- OECD GUIDELINES FOR TESTING OF CHEMICALS 423 (17th December 2001)- Council Regulation (EC) No 440/2008 (30 May 2008),- Regulation (EC) No. 1272/2008 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34d0bc62-a4f1-4672-ae35-c811792b19b8/documents/IUC5-d2c75b28-4e3c-4d22-8c38-2599beda31ac_37ddbaa9-6566-4832-aa11-3b5580d3346d.html,,,,,, "Tar, wood",91722-33-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34d0bc62-a4f1-4672-ae35-c811792b19b8/documents/IUC5-d2c75b28-4e3c-4d22-8c38-2599beda31ac_37ddbaa9-6566-4832-aa11-3b5580d3346d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tar, wood",91722-33-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34d0bc62-a4f1-4672-ae35-c811792b19b8/documents/IUC5-d2c75b28-4e3c-4d22-8c38-2599beda31ac_37ddbaa9-6566-4832-aa11-3b5580d3346d.html,,inhalation,LC50,"1,600 mg/m3",no adverse effect observed, Teflubenzuron,83121-18-0,- mouse: LOAEL 2.1 mg/kg bw/d (oncogenicity study) - rat: NOAEL 4.8 mg/kg bw/d (combined chronic toxicity and carcinogenicity study) - dog: NOAEL 17.3 mg/kg bw/d (chronic toxicity study) - monkey: NOAEL 250 mg/kg bw/d (14 -22 day dose range-finding study) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bfd25f3-ed7d-49a1-b16f-b6756c87b7c3/documents/79b1ffd3-ee79-4682-8b9f-f5ffe8ded5b6_b8eef26d-5d4a-478b-bde8-e3c90315c26f.html,,,,,, Teflubenzuron,83121-18-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bfd25f3-ed7d-49a1-b16f-b6756c87b7c3/documents/79b1ffd3-ee79-4682-8b9f-f5ffe8ded5b6_b8eef26d-5d4a-478b-bde8-e3c90315c26f.html,Chronic toxicity – systemic effects,oral,LOAEL,2.1 mg/kg bw/day,,mouse Teflubenzuron,83121-18-0,Acute oral toxicity: LD50 >5000mg/kg bw Acute inhalative toxicity: LD50 >5038 mg/kg bw Acute dermal toxicity: LD50 >2000mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bfd25f3-ed7d-49a1-b16f-b6756c87b7c3/documents/12c4312d-19b9-4d45-96d5-c7e27cc6aa9b_b8eef26d-5d4a-478b-bde8-e3c90315c26f.html,,,,,, Teflubenzuron,83121-18-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bfd25f3-ed7d-49a1-b16f-b6756c87b7c3/documents/12c4312d-19b9-4d45-96d5-c7e27cc6aa9b_b8eef26d-5d4a-478b-bde8-e3c90315c26f.html,,oral,LD50,"> 5,000 mg/kg bw",no adverse effect observed, Teflubenzuron,83121-18-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bfd25f3-ed7d-49a1-b16f-b6756c87b7c3/documents/12c4312d-19b9-4d45-96d5-c7e27cc6aa9b_b8eef26d-5d4a-478b-bde8-e3c90315c26f.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Teflubenzuron,83121-18-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bfd25f3-ed7d-49a1-b16f-b6756c87b7c3/documents/12c4312d-19b9-4d45-96d5-c7e27cc6aa9b_b8eef26d-5d4a-478b-bde8-e3c90315c26f.html,,inhalation,LC50,"> 5,038 mg/m3",no adverse effect observed, Terephthalic acid,100-21-0,"Sub-chronic Repeated dose toxicity, oral: NOAEL = 125 mg/kg bw/day (90d study) Short-term Repeated dose toxicity, inhalation: NOAEC = 10 mg/m3 (28d study) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/383d89fd-b4fa-40f0-ba46-b36f2595ae6b/documents/IUC5-f91d5451-f2eb-49fb-90d2-871f1b5b889b_9d30c49b-2e89-4362-9680-747a5e9705ba.html,,,,,, Terephthalic acid,100-21-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/383d89fd-b4fa-40f0-ba46-b36f2595ae6b/documents/IUC5-f91d5451-f2eb-49fb-90d2-871f1b5b889b_9d30c49b-2e89-4362-9680-747a5e9705ba.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,10 mg/m3,,rat Terephthalic acid,100-21-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/383d89fd-b4fa-40f0-ba46-b36f2595ae6b/documents/IUC5-f91d5451-f2eb-49fb-90d2-871f1b5b889b_9d30c49b-2e89-4362-9680-747a5e9705ba.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Terephthalic acid,100-21-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/383d89fd-b4fa-40f0-ba46-b36f2595ae6b/documents/IUC5-f91d5451-f2eb-49fb-90d2-871f1b5b889b_9d30c49b-2e89-4362-9680-747a5e9705ba.html,Repeated dose toxicity – local effects,inhalation,NOAEC,10 mg/m3,adverse effect observed,rat Terephthalic acid,100-21-0,"Acute Oral toxicity : LD50 > 15380 mg/kg bw (comparable to OECD 401, pre-GLP) Acute Inhalation toxicity: LC50(2h) = 2020 mg/m3 (guideline-comparable study, supported by less reliable data) Acute Dermal toxicity: LD50 > 2000 mg/kg bw (Reliable, guideline-compliant study) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/383d89fd-b4fa-40f0-ba46-b36f2595ae6b/documents/IUC5-0325d90f-d7e6-4d1e-95e7-91f481a4dc9c_9d30c49b-2e89-4362-9680-747a5e9705ba.html,,,,,, Terephthalic acid,100-21-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/383d89fd-b4fa-40f0-ba46-b36f2595ae6b/documents/IUC5-0325d90f-d7e6-4d1e-95e7-91f481a4dc9c_9d30c49b-2e89-4362-9680-747a5e9705ba.html,,oral,LD50,"15,380 mg/kg bw",no adverse effect observed, Terephthalic acid,100-21-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/383d89fd-b4fa-40f0-ba46-b36f2595ae6b/documents/IUC5-0325d90f-d7e6-4d1e-95e7-91f481a4dc9c_9d30c49b-2e89-4362-9680-747a5e9705ba.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Terephthalic acid,100-21-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/383d89fd-b4fa-40f0-ba46-b36f2595ae6b/documents/IUC5-0325d90f-d7e6-4d1e-95e7-91f481a4dc9c_9d30c49b-2e89-4362-9680-747a5e9705ba.html,,inhalation,LC50,"2,020 mg/m3",no adverse effect observed, Terephthaloyl dichloride,100-20-9," 15-weeks, rat NOAEL = 1220 (males), 1456 (females) mg/kg/day (1.6% of diet) based on bladder calculi and subsequent hyperplasia [CAS# 100-21-0], Reliability = 2 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dc43555-a23f-4267-9bc9-cf92b24178ae/documents/IUC5-b7be2e33-e61a-4a71-9051-d1c312510bcf_7dee3589-f36f-4b7d-98ab-f50b6e7373dd.html,,,,,, Terephthaloyl dichloride,100-20-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4dc43555-a23f-4267-9bc9-cf92b24178ae/documents/IUC5-b7be2e33-e61a-4a71-9051-d1c312510bcf_7dee3589-f36f-4b7d-98ab-f50b6e7373dd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,220 mg/kg bw/day",,rat Terephthaloyl dichloride,100-20-9,"Oral ALD, rat = 5000 mg/kg, Reliability = 2Dermal LD50, rabbit > 2000 mg/kg [CAS# 100-21-0], Reliability = 2Inhalation, 4-hr LC50, rat = 700 mg/m3, Reliability = 2 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dc43555-a23f-4267-9bc9-cf92b24178ae/documents/IUC5-38caaa9a-ca96-4eb4-baea-49a7c1f8133b_7dee3589-f36f-4b7d-98ab-f50b6e7373dd.html,,,,,, Terephthaloyl dichloride,100-20-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dc43555-a23f-4267-9bc9-cf92b24178ae/documents/IUC5-38caaa9a-ca96-4eb4-baea-49a7c1f8133b_7dee3589-f36f-4b7d-98ab-f50b6e7373dd.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Terephthaloyl dichloride,100-20-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dc43555-a23f-4267-9bc9-cf92b24178ae/documents/IUC5-38caaa9a-ca96-4eb4-baea-49a7c1f8133b_7dee3589-f36f-4b7d-98ab-f50b6e7373dd.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Terephthaloyl dichloride,100-20-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4dc43555-a23f-4267-9bc9-cf92b24178ae/documents/IUC5-38caaa9a-ca96-4eb4-baea-49a7c1f8133b_7dee3589-f36f-4b7d-98ab-f50b6e7373dd.html,,inhalation,LC50,700 mg/m3,adverse effect observed, "Terpenes and terpenoids, turpentine-oil, α-pinene fraction, oligomers",70750-57-1,Organ weight effects but no toxicologically relevant histopathological alterations were recorded in male and female rats exposed to up to 400 ppm alpha pinene by inhalation for up to 14 weeks. Sub-chronic inhalation toxicity testing in mice revealed hyperplasia of the transitional epithelium of the urinary bladder with a NOAEL of 50 ppm in both sexes. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c14a38d-772f-4db6-8c9a-96ec6e63eda3/documents/IUC5-d7791ae9-2412-4a24-aa4f-1a9e7729f7eb_30be77dd-f80c-4772-8ef0-19c77d43c804.html,,,,,, "Terpenes and terpenoids, turpentine-oil, α-pinene fraction, oligomers",70750-57-1,Not adverse effects following oral and dermal exposure. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c14a38d-772f-4db6-8c9a-96ec6e63eda3/documents/IUC5-ff213a63-3020-42b0-83ab-a2b86a75640d_30be77dd-f80c-4772-8ef0-19c77d43c804.html,,,,,, "Terpenes and terpenoids, turpentine-oil, α-pinene fraction, oligomers",70750-57-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c14a38d-772f-4db6-8c9a-96ec6e63eda3/documents/IUC5-ff213a63-3020-42b0-83ab-a2b86a75640d_30be77dd-f80c-4772-8ef0-19c77d43c804.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Terpenes and terpenoids, turpentine-oil, α-pinene fraction, oligomers",70750-57-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c14a38d-772f-4db6-8c9a-96ec6e63eda3/documents/IUC5-ff213a63-3020-42b0-83ab-a2b86a75640d_30be77dd-f80c-4772-8ef0-19c77d43c804.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "tert-(dodecyl/tetradecyl)-ammonium bis(3-(4-((5-(1,1-dimethyl-propyl)-2-hydroxy-3-nitrophenyl)azo)-3-methyl-5-hydroxy-(1H)pyrazol-1-yl)benzenesulfonamidato)chromate",192662-33-2,"No adverse effects were observed after feeding rats for four weeks with a diet containing 12000 ppm (ca 1100 mg/kg bw) of the substance (OECD 407, GLP). ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/85ce7480-1ae0-4c2f-9ec7-0d1f669b2b0c/documents/IUC5-3d03f6b2-3652-4229-b666-91951809e66a_96658c22-a29e-4247-9b88-1b15a73dee2d.html,,,,,, "tert-(dodecyl/tetradecyl)-ammonium bis(3-(4-((5-(1,1-dimethyl-propyl)-2-hydroxy-3-nitrophenyl)azo)-3-methyl-5-hydroxy-(1H)pyrazol-1-yl)benzenesulfonamidato)chromate",192662-33-2,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/85ce7480-1ae0-4c2f-9ec7-0d1f669b2b0c/documents/IUC5-3d03f6b2-3652-4229-b666-91951809e66a_96658c22-a29e-4247-9b88-1b15a73dee2d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,075 mg/kg bw/day",,rat "tert-(dodecyl/tetradecyl)-ammonium bis(3-(4-((5-(1,1-dimethyl-propyl)-2-hydroxy-3-nitrophenyl)azo)-3-methyl-5-hydroxy-(1H)pyrazol-1-yl)benzenesulfonamidato)chromate",192662-33-2,"The substance did not cause mortality upon oral or dermal exposure of rats at the limit dose of 2000 mg/kg bw as tested in GLP compliant studies performed according to OECD testing guidelines 401 and 402, respectively (Ciba-Geigy 1992 a and b). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85ce7480-1ae0-4c2f-9ec7-0d1f669b2b0c/documents/IUC5-452a60bd-8ab6-4018-98de-6acc87fd6cbe_96658c22-a29e-4247-9b88-1b15a73dee2d.html,,,,,, tert-butyl 2-ethylperoxyhexanoate,3006-82-4,There are two repeated dose toxicity studies available (28-day and 90-day study) which were conducted according to GLP and the respective OECD/EU test guideline. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be1a40e2-7b8b-4a3a-814c-061fc6bb22e1/documents/c08c29ac-cc1f-41a9-bf0c-04fcc873c108_3cd3cda2-563f-4f43-b660-456314ace93b.html,,,,,, tert-butyl 2-ethylperoxyhexanoate,3006-82-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be1a40e2-7b8b-4a3a-814c-061fc6bb22e1/documents/c08c29ac-cc1f-41a9-bf0c-04fcc873c108_3cd3cda2-563f-4f43-b660-456314ace93b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat tert-butyl 2-ethylperoxyhexanoate,3006-82-4,In a study similar to OECD TG 401 the LD50 in Sprague-Dawley rats was >10000 mg/kg bw. In a study similar to OECD TG 403 the LC50 in rats was calculated to be 42.2 mg/L with 95% confidence limits of 30.8 and 58.0 mg/L. In a study similar to OECD TG 402 the LD50 for male and female rats was 16818 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be1a40e2-7b8b-4a3a-814c-061fc6bb22e1/documents/6bf74ed5-69b9-4892-9322-872928780ecc_3cd3cda2-563f-4f43-b660-456314ace93b.html,,,,,, tert-butyl 2-ethylperoxyhexanoate,3006-82-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be1a40e2-7b8b-4a3a-814c-061fc6bb22e1/documents/6bf74ed5-69b9-4892-9322-872928780ecc_3cd3cda2-563f-4f43-b660-456314ace93b.html,,oral,discriminating dose,"10,000 mg/kg bw",no adverse effect observed, tert-butyl 2-ethylperoxyhexanoate,3006-82-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be1a40e2-7b8b-4a3a-814c-061fc6bb22e1/documents/6bf74ed5-69b9-4892-9322-872928780ecc_3cd3cda2-563f-4f43-b660-456314ace93b.html,,dermal,LD50,"16,820 mg/kg bw",adverse effect observed, tert-butyl 2-ethylperoxyhexanoate,3006-82-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be1a40e2-7b8b-4a3a-814c-061fc6bb22e1/documents/6bf74ed5-69b9-4892-9322-872928780ecc_3cd3cda2-563f-4f43-b660-456314ace93b.html,,inhalation,LC50,"42,200 mg/m3",adverse effect observed, "tert-butyl 3,5,5-trimethylperoxyhexanoate",13122-18-4,"Tert-Butylperoxy-3,5,5-trimethylhexanoat was tested in a 90-day repeated dose toxicity study by oral application in rats according to EU method B.26 and OECD guideline 408. The test item was administered at 10, 40 and 160 mg/kg bw/day. A NOAEL of 160 mg/kg bw/day in males and female rats was determined. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): OECD 408/GLP ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4aab52bc-e4f2-4f44-937d-cd28de64eeee/documents/8d0c1f1a-848e-41b9-8d47-c9ac84a99f3d_265d04cb-16c5-4974-9b87-b4fd8be99213.html,,,,,, "tert-butyl 3,5,5-trimethylperoxyhexanoate",13122-18-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4aab52bc-e4f2-4f44-937d-cd28de64eeee/documents/8d0c1f1a-848e-41b9-8d47-c9ac84a99f3d_265d04cb-16c5-4974-9b87-b4fd8be99213.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,160 mg/kg bw/day,,rat "tert-butyl 3,5,5-trimethylperoxyhexanoate",13122-18-4,"Tert-Butylperoxy-3,5,5-trimethylhexanoat was tested for acute toxicity by oral, inhalation and dermal application in fixed dose studies in the rat. The studies revealed an LD50 (oral) value of 12905 mg/kg bw an LC50 value (4 h, inhalation) of greater than 0.8 mg/L (800 mg/m³) and an LD50 (dermal) of greater than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aab52bc-e4f2-4f44-937d-cd28de64eeee/documents/4ccf382e-dfad-422d-9493-9dd07c4d0ffc_265d04cb-16c5-4974-9b87-b4fd8be99213.html,,,,,, "tert-butyl 3,5,5-trimethylperoxyhexanoate",13122-18-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aab52bc-e4f2-4f44-937d-cd28de64eeee/documents/4ccf382e-dfad-422d-9493-9dd07c4d0ffc_265d04cb-16c5-4974-9b87-b4fd8be99213.html,,oral,LD50,"12,905 mg/kg bw",adverse effect observed, "tert-butyl 3,5,5-trimethylperoxyhexanoate",13122-18-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aab52bc-e4f2-4f44-937d-cd28de64eeee/documents/4ccf382e-dfad-422d-9493-9dd07c4d0ffc_265d04cb-16c5-4974-9b87-b4fd8be99213.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "tert-butyl 3,5,5-trimethylperoxyhexanoate",13122-18-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4aab52bc-e4f2-4f44-937d-cd28de64eeee/documents/4ccf382e-dfad-422d-9493-9dd07c4d0ffc_265d04cb-16c5-4974-9b87-b4fd8be99213.html,,inhalation,LC50,800 mg/m3,adverse effect observed, Tert-butyl 3-Cyano-4-oxo-pyrrolidine-1-carboxylate,175463-32-8,"OECD guideline for testing of chemicals, TG420 (2001) acute oral toxicity - fixed dose procedure300 < DL50 < 2000 mg/kg for rats ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cf4a40a-9189-4135-808c-50783a74cecf/documents/IUC5-61d327d4-3189-4cb4-93e3-15708ded2c4f_b060d416-61bb-42f8-b35a-bb93d296358b.html,,,,,, Tert-butyl 3-Cyano-4-oxo-pyrrolidine-1-carboxylate,175463-32-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cf4a40a-9189-4135-808c-50783a74cecf/documents/IUC5-61d327d4-3189-4cb4-93e3-15708ded2c4f_b060d416-61bb-42f8-b35a-bb93d296358b.html,,oral,LD50,300 mg/kg bw,, tert-butyl 3-oxobutanoate,1694-31-1," Acute oral Toxicity:  The acute oral toxicity dose (LD50) for tert-butyl 3-oxobutanoate (1694-31-1) was based on data available for the structurally similar read across chemicals. The LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, tert-butyl 3-oxobutanoate (1694-31-1) cannot be classified for acute oral toxicity.  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/561c57be-7c91-4cd9-950f-7a9bfae10407/documents/e2e7f58c-79c2-40a7-8813-3f53aac95043_9a542b05-4194-4b07-8046-a837957bafcb.html,,,,,, tert-butyl 3-oxobutanoate,1694-31-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/561c57be-7c91-4cd9-950f-7a9bfae10407/documents/e2e7f58c-79c2-40a7-8813-3f53aac95043_9a542b05-4194-4b07-8046-a837957bafcb.html,,oral,LD50,"3,980 mg/kg bw",no adverse effect observed, "tert-Butyl 4-({6-[7-cyclopentyl-6-(dimethylcarbamoyl)-7H-pyrrolo[2,3-d]pyrimidin-2-yl]amino}pyridin-3-yl)piperazine-1-carboxylate",1374639-78-7, The oral LD50 value of LEE011-A3 in Wistar rats was established to be within the range of 300-2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e4b5b27-5b1a-47b9-9c5f-7a4319e99958/documents/c9f2229b-5c44-4cc1-8910-1ab738e08e7c_e7418f80-8a3b-4eee-92f9-15652f32915a.html,,,,,, "tert-Butyl 4-({6-[7-cyclopentyl-6-(dimethylcarbamoyl)-7H-pyrrolo[2,3-d]pyrimidin-2-yl]amino}pyridin-3-yl)piperazine-1-carboxylate",1374639-78-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e4b5b27-5b1a-47b9-9c5f-7a4319e99958/documents/c9f2229b-5c44-4cc1-8910-1ab738e08e7c_e7418f80-8a3b-4eee-92f9-15652f32915a.html,,oral,LD50,500 mg/kg bw,adverse effect observed, "tert-butyl 5'-(3-(3,5-dichloro-4-fluorophenyl)-4,4,4-trifluorobut-2-enoyl)-3'H-spiro[azetidine-3,1'-isobenzofuran]-1-carboxylate",1398610-04-2,Oral: Read across from Sarolaner step 2 The oral LD50 value of test item in Wistar Han rats was established to exceed 2000 mg/kg body weight according to the OECD 423. Dermal: No data available Inhalation: No data available ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/426c348e-1e90-4873-8af1-b686018c75a9/documents/6d15d753-86e2-4d04-a5c3-e0c1ea756b1d_6e9d9c73-c016-4f9d-901b-511f5e1e84e2.html,,,,,, "tert-butyl 5'-(3-(3,5-dichloro-4-fluorophenyl)-4,4,4-trifluorobut-2-enoyl)-3'H-spiro[azetidine-3,1'-isobenzofuran]-1-carboxylate",1398610-04-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/426c348e-1e90-4873-8af1-b686018c75a9/documents/6d15d753-86e2-4d04-a5c3-e0c1ea756b1d_6e9d9c73-c016-4f9d-901b-511f5e1e84e2.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, tert-butyl acrylate,1663-39-4," NOAEC = 60 ppm (equivalent to 0.319 mg/L) (Wistar rat, vapour inhalation, OECD TG 413, 422) The inhalation of 180 ppm tert-butyl acrylate vapours (equivalent to 0.956 mg/L) by male and female Wistar rats in a combined sub-chronic toxicity study with a reproduction / developmental toxicity screening test caused slight irritation of the eyes and upper respiratory tract, retarded body weight development, mild impairment of renal function in the males, a reduced general health status and two deaths during gestation in the females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aeb728d0-85ac-418f-9122-0153c2318400/documents/IUC5-8ae007d5-d615-40a8-966c-6789a1b373fe_257b0895-7697-483c-96ca-7865c9459d11.html,,,,,, tert-butyl acrylate,1663-39-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aeb728d0-85ac-418f-9122-0153c2318400/documents/IUC5-8ae007d5-d615-40a8-966c-6789a1b373fe_257b0895-7697-483c-96ca-7865c9459d11.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,319 mg/m3,,rat tert-butyl acrylate,1663-39-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aeb728d0-85ac-418f-9122-0153c2318400/documents/IUC5-8ae007d5-d615-40a8-966c-6789a1b373fe_257b0895-7697-483c-96ca-7865c9459d11.html,Repeated dose toxicity – local effects,inhalation,NOAEC,319 mg/m3,adverse effect observed,rat tert-butyl acrylate,1663-39-4," Oral: LD50 = ca. 1047 mg/kg bw (rat, BASF test) Dermal: LD50: ca. 2000 mg/kg bw (rabbit, occlusive) Inhalation: LC50 = 7.01 mg/L (rat, 4h) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aeb728d0-85ac-418f-9122-0153c2318400/documents/IUC5-eb7a4692-a360-4247-849a-7a768f5c529f_257b0895-7697-483c-96ca-7865c9459d11.html,,,,,, tert-butyl acrylate,1663-39-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aeb728d0-85ac-418f-9122-0153c2318400/documents/IUC5-eb7a4692-a360-4247-849a-7a768f5c529f_257b0895-7697-483c-96ca-7865c9459d11.html,,oral,LD50,"1,047 mg/kg bw",adverse effect observed, tert-butyl acrylate,1663-39-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aeb728d0-85ac-418f-9122-0153c2318400/documents/IUC5-eb7a4692-a360-4247-849a-7a768f5c529f_257b0895-7697-483c-96ca-7865c9459d11.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, tert-butyl acrylate,1663-39-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aeb728d0-85ac-418f-9122-0153c2318400/documents/IUC5-eb7a4692-a360-4247-849a-7a768f5c529f_257b0895-7697-483c-96ca-7865c9459d11.html,,inhalation,LC50,"7,010 mg/m3",adverse effect observed, tert-butyl bromoacetate,5292-43-3, Oral LD50: between 300 - 500 mg/kg bw Dermal LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6fa8879-2cb6-4461-8270-a7f0c1a82a48/documents/398dfb19-570f-4950-9bcc-6d1d3d3b7608_ef46b832-865f-4eb8-a23f-477374bbae78.html,,,,,, tert-butyl bromoacetate,5292-43-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6fa8879-2cb6-4461-8270-a7f0c1a82a48/documents/398dfb19-570f-4950-9bcc-6d1d3d3b7608_ef46b832-865f-4eb8-a23f-477374bbae78.html,,oral,LD50,300 mg/kg bw,adverse effect observed, tert-butyl bromoacetate,5292-43-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a6fa8879-2cb6-4461-8270-a7f0c1a82a48/documents/398dfb19-570f-4950-9bcc-6d1d3d3b7608_ef46b832-865f-4eb8-a23f-477374bbae78.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, tert-butyl isocyanate,1609-86-5,no data ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/834c329f-6ad5-4c1e-a222-0518554541fc/documents/IUC5-394b606e-1283-4aa1-94b7-491fe392f777_3495a0c6-4696-4fee-a21b-a8dac0d2f53b.html,,,,,, tert-butyl isocyanate,1609-86-5,"In a valid oral toxicity study a LD50 = 185 mg/kg bw for rats (male) was found2 acute inhalation toxicity studies are available:In the key study according OECD 403 for male + female rats a LC50 = 1593 mg/m³ air (analytical vapour concentration) was found. In an inhalation-hazard test rats were placed in a 10 l glass chamber and were exposed whole body for 3 or 10 min to the vapour of tert-butylisocyanate and were observed for 14 d after the exposure to the test substance. 3 min. exposure: 5/5 males died within 4 minutes after start of exposure; 4/5 females died within 6-12 minutes after start of exposure, signs of irritation were found;  10 min.exposure: all rats died within 4 minutes after start of exposure, signs of irritation were found.No study was available for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/834c329f-6ad5-4c1e-a222-0518554541fc/documents/IUC5-2bc88e67-8f8d-41f0-90cd-cb0a8c435733_3495a0c6-4696-4fee-a21b-a8dac0d2f53b.html,,,,,, tert-butyl isocyanate,1609-86-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/834c329f-6ad5-4c1e-a222-0518554541fc/documents/IUC5-2bc88e67-8f8d-41f0-90cd-cb0a8c435733_3495a0c6-4696-4fee-a21b-a8dac0d2f53b.html,,oral,LD50,185 mg/kg bw,, tert-butyl isocyanate,1609-86-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/834c329f-6ad5-4c1e-a222-0518554541fc/documents/IUC5-2bc88e67-8f8d-41f0-90cd-cb0a8c435733_3495a0c6-4696-4fee-a21b-a8dac0d2f53b.html,,inhalation,LC50,"1,593 mg/m3",, Tert-butyl methyl2-oxopropylcarbamate,532410-39-2," ACD/Percepta model for acute oral toxicity on mouse and rat provides LD50predictions for mice by oral administration route,based on the GALAS methodology. Reliability of predictions is estimated in terms of reliability index (RI),which ranges from0 to 1 and takes into account the similarity of the target with the training set compounds and the consistency of experimental values for similar compounds. For tert-Butyl methyl(2-oxopropyl)carbamate, ACD/Percepta provided : - in mouse an LD50 prediction equal to 1800 mg/kg, and the prediction was assessed as moderate reliable being the reliability index equal to 0.67; in rat an LD50 prediction equal to 2800 mg/kg, and the prediction is assessed as moderate reliable being the reliability index equal to 0.70. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34770272-9ed6-4845-aeac-aabe86fc2986/documents/8743a8f2-0221-46f4-82e9-4781f93f07f8_93201462-1672-469a-8b21-9c65516d6b02.html,,,,,, tert-butyl peracetate,107-71-1," Data obtained from the Combined Repeated-Dose and Reproduction / Developmental Screening Study (OECD 422) in rats revealed an oral NOAEL of 50 mg/kg bw/day calculated as peroxide for parental effects. Therefore, the NOAEL is expected to be 100 mg/kg bw/day for the test material (50% act. ingr. in Shellsol T). A sub-acute inhalation study in rats indicates a NOAEC value of 280 mg/cubic meter for the active ingredient. The NOAEC is calculated to be 560 mg/cubic meter for the test material (50% tert-butyl peroxyacetate in Shellsol T). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): In accordance with column 2 of REACH Annex IX, the test repeated dose toxicity after dermal application (required in section 8.6) does not need to be conducted as repeated dose toxicity studies for oral as well as inhalation application are available. Thus, no test on repeated dose dermal toxicity has to be conducted and risk assessment is based on the oral and inhalation key studies. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): equivalent to OECD guideline; acceptable experimental procedure for assessment Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): equivalent to OECD guideline; acceptable experimental procedure for assessment Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): In accordance with column 2 of REACH Annex IX, the test repeated dose toxicity after dermal application (required in section 8.6) does not need to be conducted as repeated dose toxicity studies for oral as well as inhalation application are available. Thus, no test on repeated dose dermal toxicity has to be conducted and risk assessment is based on the oral and inhalation key studies. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): according to OECD guideline, GLP-conform ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bcabbafe-e4c0-4a07-b2ab-d3093c3ab935/documents/507b47cf-4737-47d1-92fa-740df3e0d970_8310318d-e5b4-4444-a428-80a043369582.html,,,,,, tert-butyl peracetate,107-71-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bcabbafe-e4c0-4a07-b2ab-d3093c3ab935/documents/507b47cf-4737-47d1-92fa-740df3e0d970_8310318d-e5b4-4444-a428-80a043369582.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,560 mg/m3,,rat tert-butyl peracetate,107-71-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bcabbafe-e4c0-4a07-b2ab-d3093c3ab935/documents/507b47cf-4737-47d1-92fa-740df3e0d970_8310318d-e5b4-4444-a428-80a043369582.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat tert-butyl peracetate,107-71-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bcabbafe-e4c0-4a07-b2ab-d3093c3ab935/documents/507b47cf-4737-47d1-92fa-740df3e0d970_8310318d-e5b4-4444-a428-80a043369582.html,Repeated dose toxicity – local effects,inhalation,NOAEC,560 mg/m3,no adverse effect observed,rat tert-butyl peracetate,107-71-1," Based on the test material containing 50% of the active ingredient the following values are expected to be 3843 mg/kg bw (combined male/female rats) for the acute oral LD50 value, 9.2 mg/L (as vapour and aerosol) for the acute inhalation LC50 value as wells as 7135.5 mg/kg bw (combined male/female rats) for the acute dermal LD50 value.  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): similar to OECD guideline Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The study was equivalent to OECD guidline 403. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): similar to OECD guideline ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcabbafe-e4c0-4a07-b2ab-d3093c3ab935/documents/a31f0a81-c360-4033-b0c6-8c478d4112b0_8310318d-e5b4-4444-a428-80a043369582.html,,,,,, tert-butyl peracetate,107-71-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcabbafe-e4c0-4a07-b2ab-d3093c3ab935/documents/a31f0a81-c360-4033-b0c6-8c478d4112b0_8310318d-e5b4-4444-a428-80a043369582.html,,oral,LD50,"3,843 mg/kg bw",no adverse effect observed, tert-butyl peracetate,107-71-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcabbafe-e4c0-4a07-b2ab-d3093c3ab935/documents/a31f0a81-c360-4033-b0c6-8c478d4112b0_8310318d-e5b4-4444-a428-80a043369582.html,,dermal,LD50,"7,135.5 mg/kg bw",no adverse effect observed, tert-butyl peracetate,107-71-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bcabbafe-e4c0-4a07-b2ab-d3093c3ab935/documents/a31f0a81-c360-4033-b0c6-8c478d4112b0_8310318d-e5b4-4444-a428-80a043369582.html,,inhalation,LC50,"9,200 mg/m3",adverse effect observed, tert-butyl peroxyisobutyrate,109-13-7, Based on the results obtained from testing the acute oral LD50 was determined to be greater than 2000 mg/kgbw. The 4 hour LC50 value determined in an acute inhalation toxicity study was considered to be greater than 2.53 mg/L and below 6.8 mg/L. No acute dermal toxicity study was conducted as no hazard after short-term exposure is expected based on experimental data of another 41 organic peroxides. This assumption is supported by a LD50 value > 2500 mg/kgbwdetermined in an acute dermal toxicity study with tert-butylperoxypivalate(read-across). It is therefore assumed that tert-butylperoxyisobuytratealso revealed a LD50 value > 2000 mg/kgbw after short-term exposure due to structure similarity. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7599dce-f5b6-4942-aab5-57c6d09e015e/documents/b1e4b2e9-2c5a-4812-afdb-23c1d6784f61_5693169a-3752-49ce-bbe6-ae3493b43512.html,,,,,, tert-butyl peroxyisobutyrate,109-13-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7599dce-f5b6-4942-aab5-57c6d09e015e/documents/b1e4b2e9-2c5a-4812-afdb-23c1d6784f61_5693169a-3752-49ce-bbe6-ae3493b43512.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, tert-butyl peroxyisobutyrate,109-13-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d7599dce-f5b6-4942-aab5-57c6d09e015e/documents/b1e4b2e9-2c5a-4812-afdb-23c1d6784f61_5693169a-3752-49ce-bbe6-ae3493b43512.html,,inhalation,discriminating conc.,"2,530 mg/m3",adverse effect observed, tert-butyl peroxyneodecanoate,26748-41-4," In a read-across approach tert.butylperoxy-3,5,5-trimethylhexanoat was tested in a 90-day repeated dose toxicity study by oral application in rats according to EU method B.26 and OECD guideline 408. The test item was administered at 10, 40 and 160 mg/kg bw/day. A NOAEL of 160 mg/kg bw/day in males and female rats was determined. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Guideline and GLP compliant study. Reliable with restrictions due to read-across approach. For read-across justification please refer to IUCLID section 13. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab1619bc-7623-45ae-b9f8-3fd1a96de16e/documents/0a60c3ee-4820-47ca-bced-22c9aa595710_b72ea3bb-4e28-4ac2-acb8-3db0bbc70d1a.html,,,,,, tert-butyl peroxyneodecanoate,26748-41-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab1619bc-7623-45ae-b9f8-3fd1a96de16e/documents/0a60c3ee-4820-47ca-bced-22c9aa595710_b72ea3bb-4e28-4ac2-acb8-3db0bbc70d1a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,160 mg/kg bw/day,,rat tert-butyl peroxyneodecanoate,26748-41-4," Tert-butylperoxyneodecanoatewas tested for acute toxicity by oral, inhalation and dermal routes. The studies revealed an LD50 (oral) value of 8082 mg/kgbw a LC50 value (4 h, inhalation) of greater than 37.5 mg/L and a LD50 (dermal) of greater than 6000 mg/kgbw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab1619bc-7623-45ae-b9f8-3fd1a96de16e/documents/f120a600-226c-41c0-833d-f83d347bda4f_b72ea3bb-4e28-4ac2-acb8-3db0bbc70d1a.html,,,,,, tert-butyl peroxyneodecanoate,26748-41-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab1619bc-7623-45ae-b9f8-3fd1a96de16e/documents/f120a600-226c-41c0-833d-f83d347bda4f_b72ea3bb-4e28-4ac2-acb8-3db0bbc70d1a.html,,oral,LD50,"8,082 mg/kg bw",no adverse effect observed, tert-butyl peroxyneodecanoate,26748-41-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab1619bc-7623-45ae-b9f8-3fd1a96de16e/documents/f120a600-226c-41c0-833d-f83d347bda4f_b72ea3bb-4e28-4ac2-acb8-3db0bbc70d1a.html,,dermal,discriminating dose,"6,000 mg/kg bw",no adverse effect observed, tert-butyl peroxyneodecanoate,26748-41-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab1619bc-7623-45ae-b9f8-3fd1a96de16e/documents/f120a600-226c-41c0-833d-f83d347bda4f_b72ea3bb-4e28-4ac2-acb8-3db0bbc70d1a.html,,inhalation,LC50,"37,500 mg/m3",no adverse effect observed, tert-butyl peroxypivalate,927-07-1,"  A study to according OECD 408/GLP was performed with the structural analogue tert-butyl 3,5,5-tris(methylperoxy)hexanoate (TBPIN, CAS 13122 -18 -4). The test item was administered by oral gavage at 10, 40 and 160 mg/kg bw/day to rats. No adverse effects were observed up to the high dose level. A NOAEL of 160 mg/kg bw/day in males and female rats was determined. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): OECD 408/ GLP (Read-Across) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcae1d59-bbf4-4e67-95d1-b45f552d4057/documents/add36420-f0d2-4bf9-8b1e-40e6ece588d2_8ad7c967-03b3-4d2f-a494-a18df3dacc53.html,,,,,, tert-butyl peroxypivalate,927-07-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fcae1d59-bbf4-4e67-95d1-b45f552d4057/documents/add36420-f0d2-4bf9-8b1e-40e6ece588d2_8ad7c967-03b3-4d2f-a494-a18df3dacc53.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,160 mg/kg bw/day,,rat tert-butyl peroxypivalate,927-07-1,"In an acute oral toxicits study with TBPPI in rats a combinded LD50 value of 4169 mg/kg bw was determined. The 4 hours LC50 was calculated to be 7.79 mg/L with 95 % confidence limits of 5.89 and 10.28 mg/L (exposure to mist). In an acute dermal toxicits study with TBPPI in rabbits a LD50 value of 2500 mg/kg bw was determined. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): sumilar to OECD 401/non-GLP Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): similar to OECD 403/non-GLP Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): similar to OECD 402/GLP ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcae1d59-bbf4-4e67-95d1-b45f552d4057/documents/6f473c09-da05-400b-abea-518c32ec4d90_8ad7c967-03b3-4d2f-a494-a18df3dacc53.html,,,,,, tert-butyl peroxypivalate,927-07-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcae1d59-bbf4-4e67-95d1-b45f552d4057/documents/6f473c09-da05-400b-abea-518c32ec4d90_8ad7c967-03b3-4d2f-a494-a18df3dacc53.html,,oral,LD50,"4,169 mg/kg bw",adverse effect observed, tert-butyl peroxypivalate,927-07-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcae1d59-bbf4-4e67-95d1-b45f552d4057/documents/6f473c09-da05-400b-abea-518c32ec4d90_8ad7c967-03b3-4d2f-a494-a18df3dacc53.html,,dermal,LD50,"2,500 mg/kg bw",adverse effect observed, tert-butyl peroxypivalate,927-07-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fcae1d59-bbf4-4e67-95d1-b45f552d4057/documents/6f473c09-da05-400b-abea-518c32ec4d90_8ad7c967-03b3-4d2f-a494-a18df3dacc53.html,,inhalation,LC50,"7,790 mg/m3",adverse effect observed, "tert-butyl α,α-dimethylbenzyl peroxide",3457-61-2,"OECD 408 study The oral toxicity of tert-butyl cumyl peroxide (CAS 3457-61-2) in rats following daily oral administration for 13 consecutive weeks and recovery from any treatment-related effect during a period of 6 weeks, were investigated in this study (Lombogardi, 2018). Three groups, each of 10 male and 10 female Sprague Dawley rats, received the test item by gavage at dosages of 50, 100 and 400mg/kg/day for 13 consecutive weeks. A fourth similarly constituted group received the vehicle alone (corn oil) and acted as a control. Five additional animals for each sexwere included in the high dose and control groups for recovery assessment. The following investigations were performed: daily clinical signs, weekly detailed clinical signs (removal from cage and open field observations), evaluation of sensory reactivity to stimuli and motor activity, body weight, food consumption, ophthalmoscopy, oestrus cycle, clinical pathology investigations (including bone marrow smears), terminal body weight, organ weights, macroscopic observations, histopathological examination and spermanalysis. One male and one female from the control group were found dead on Days 21 and 83 of treatment period, respectively. One male animal dosed at 100mg/kg/day was found dead on Day 43 while one female rat dosed at 400mg/kg/day, was found dead on Day 23 of the treatment period. No clinical signs were observed in the 2 control group animals prior to death. Matted fur, salivation and/or hunched posturewere seen in the males receiving 100mg/kg/day and in the females receiving 400mg/kg/day during the third week of treatment period. In addition, piloerection was seen in these 2 animals up to the day before death. Post mortem examination showed multiple, dark areas in the lungs with red colour in the cervical lymph nodes and thymus in the control male; red, fluid contents in the thoracic cavity and red colour in the lungs in the control female; pale/creamy contents in the thoracic cavity and adhesions between heart and all pulmonary lobes in the female dosed at 400mg/kg/day. Histopathological evaluation identified the factor contributory to the death of these unscheduled animals in a misdosing procedure. Macroscopically, the male dosed at 100mg/kg/day showed enlarged and swollen liver; the histopathological evaluation revealed minimal, multifocal centrilobular hepatocytic hypertrophy in the liver and mild bilateral nephropathy, associated with hyaline droplet accumulation (a2µ-globulin) in the renal tubules. The pathological picture did not clearly establish the cause of death. Salivation was observed in all male and female treated groups, and in one control female animal. This sign was evident starting fromWeek 1 in animals dosed at 400mg/kg/day, while it gradually appeared during the treatment period in those treated at 50 and 100mg/kg/day. Hunched posture and/or matted fur were also observed in male and female animals from all treated groups, with a dose-related severity and incidence. In addition, piloerection was seen in animals from all groups (including controls) with increasing severity and incidence, from Week 3 of the study up to the end of treatment period. These signs were no longer observed during recovery period. Skin fur staining and/or hairloss were also observed in a number of animals from all groups. A palpable mass was seen in a single female animal dosed at 100mg/kg/day starting from Day 90 of the treatment period. Weekly detailed clinical signs (removal from cage and open field measurements) No changes of toxicological significance were found at the weekly clinical examination during treatment and recovery periods, which included an evaluation of neurotoxicity. No differences between treated and control groups were evident at the functional tests and at the motor activity measurements at the end of treatment and recovery periods. Slight statistically significant decreases in body weight and body weight gain were observed in the males dosed at 400mg/kg/day when compared to controls during treatment period. Very slight reductions were also seen in the females dosed at 400mg/kg/day. These reductions gradually decreased during the recovery period. Slight but statistically significant decreases in food consumption were occasionally observed in the animals receiving 400mg/kg/day during the treatment period. These decreases were no longer observed during the recovery period. No significant findings were detected at the ophthalmoscopic examinations performed during the study. No treatment-related anomalies were noted in the oestrous cycle when compared to controls. A decrease of erythrocytes, haemoglobin and haematocrit was recorded in some females dosed at 400mg/kg/day. Changes were insufficient in magnitude to represent an adverse anaemia, even though they could represent an effect of the test item. No other changes of toxicological relevance were observed. The findings recorded at the Dosing Phase were no longer observed at the end of recovery. No changes of coagulation of toxicological significance were observed. Fluctuations of some biochemical parameters, were recorded in treated animals. Due to the slight severity and/or absence of dose-relation, theywere not considered to be of toxicological significance. Most of the findings recorded at the Dosing Phase were no longer observed at the end of recovery. High proteinuria, ketonuria and increased urobilinogen were observed in few males dosed at 400mg/kg/day. Ketonuria was also recorded in one male receiving 100mg/kg/day. No findings were recorded at the end of recovery, confirming reversibility. Two males and two females dosed at 400mg/kg/day showed a slight increase of the erythroid mature cells in bone marrow in week 13, leading to a decrease of theM/E ratio. Male no. A2196082 also showed slight decrease of segmented neutrophils. No other relevant changes in the number and/or morphology of cells were recorded. Due to the absence of peripheral erythrocytes changes, the above findings were considered of no toxicological relevance. Terminal body weights showed statistically significant decreases in animals dosed at 400mg/kg/day when compared to controls at the end of treatment period. Partial or complete recovery was observed at the end of recovery period. Increases in absolute and/or relative kidney and liver weights were observed in animals from all treated groups at the end of treatment. No significant differences were observed at the end of recovery in either sexes. The relative weight of the spleen was increased in the males receiving 400mg/kg/day, while the relative weight of the thyroid showed increases in the females dosed at 100 and 400mg/kg/day. Only a slight increase of the thyroid relative weight in the females was seen at the end of recovery. In addition, increases in the relative weight of epididymides and testes were seen in the high dose males at the end of treatment and recovery. Without significant clear correlation with histopathology, the increases of the relative weights of the spleen, thyroid, testes and epididymides were considered to be of no toxicological relevance. At final post mortem examination, a treatment-related change was noted in males receiving 400mg/kg/day (high dose), represented by an enlargement and/or swollen consistency and/or pale colour of the kidneys and liver. Enlarged and pale kidneys were again observed in 2 out of 5 recovery males dosed at 400mg/kg/day, as well as pale colour of the liver. Treatment-related changes were seen in the kidney of males receiving Tert-butyla,a-dimethylbenzyl peroxide at >= 50mg/kg/day and in the liver of males and females dosed at 400mg/kg/day. The renal findings observed were represented by an increase of hyalin droplets or a2µ-globulin, in the proximal tubule in the cortex or cortico-medullary junction, confirmed immunohistochemically by a minimal to moderate positivity with a dose-related trend. Nephropathy was also seen associated with an increased dose-dependent severity mainly at >=100mg/kg/day. Minimal, multifocal centrilobular hepatocellular hypertrophy was only observed in the liver of male and female rats dosed at 400mg/kg/day. Hepatocyte hypertrophy could be considered an adaptative change. After the recovery period, the treatment-related changes in the liver were seen reversible in males and females. However, two males still showed a minimal increase of a2u-globulin, in the proximal tubule in the cortex, although not confirmed immunohistochemically. Mild to marked nephropathy was only noted in 2 out of 4 males involved. The renal pathology could be considered still undergoing reversal at the end of the treatment-free recovery period. No differences were observed in spermmotility, morphology and concentration in treated males compared to controls at the end of treatment. Since no treatment-related effects were seen between control treated males no assessment was performed in males of the recovery group. In conclusion, signs of effects related to treatment with tert-butyl cumyl peroxide (CAS 3457-61-2) were observed with increasing incidence and severity in animals from all treated groups when administered by oral gavage for 13 consecutive weeks at the dosages of 50, 100 and 400mg/kg/day. Most of these effects (clinical signs, slight decreases in body weight and food consumption, slight changes in haematological, biochemical and urinalysis parameters, slight increases in liver and/or kidney weights), observed at >= 50mg/kg/day, were not considered to be adverse, due to the low magnitude and/or complete reversibility. These findings were associated to a minimal centrilobular hepatocellular hypertrophy in male and female animal at 400mg/kg/day and a nephropathy in the male animals dosed at >= 100mg/kg/day. The centrilobular hepatocellular hypertrophy in the liver is often due to induction of metabolic enzymes and as such it is a direct effect of the test item. It is well-established as an adaptive and non-adverse change in the absence (as in this study) of histologic or clinical pathology alterations indicative of liver degenerative changes. Among these changes, adverse test item related effects (nephropathy) were observed in the kidneys of male rats receiving >= 100mg/kg/day. The hyaline droplets in renal tubular epithelium were associated with a2µ-globulin accumulation as confirmed by immunohistochemistry. Because humans do not have a protein that behaves in a manner comparable to a2u-globulin, on a qualitative basis, there is not concordance for this particular key event between male rats and humans and therefore this mode of action is qualitatively not relevant to humans (Hard et al., 2013)(1). Therefore, it can be concluded that the high dose of 400mg/kg/day may be considered as the No Observed Adverse Effect Level (NOAEL) for this study, excluding the male rat-specific a2u-globulin nephropathy.   OECD 422 study The toxic effects on rats of both sexes after repeated dosing with Luperox 801 (97% tert-butyl cumyl peroxide (CAS 3457-61-2)) by oral route was evaluated in an OECD 422 study (Liberati, 2013). The test item, suspended in corn oil, was administered by oral gavage to 3 groups of 10 males and 10 females each as indicated below at the doses of 75, 150 and 600 mg/kg bw/d. A similar constituted control group (Group 1) received the vehicle alone during the treatment period.Males were treated for a total of 33 days including 2 weeks prior to pairing and continuously thereafter, up to the day before necropsy. Females were treated for 2 weeks before pairing, thereafter during pairing, post coitum and lactation periods until Day 3 post partum. The following investigations were performed in all groups: body weight, clinical signs (including neurotoxicity assessment, motor activity and sensory reaction to stimuli), food consumption, clinical pathology investigations (haematology, clinical chemistry and urinalysis), macroscopic observations, organ weights and histopathological examination. Tremors, piloerection and salivation were the most relevant clinical signs detected in high dose males and females during the whole treatment period, at the daily clinical examination performed at 0.5-1 hour after treatment. In addition ataxia was detected in 7 out 10 high dose females on Day 2 of the pre mating period. Although its transient appearance of one day, the sign could be considered related to treatment, whereas it was also seen in the preliminary study (Liberati, 2012, RTC Study No. 88780EXT) at the dosage of 1000 mg/kg/day. Salivation was also detected in mid-dose animals during the whole treatment period. One control female judged to be in extremis was killed on post coitum Day 18. Body weight and body weight gain of both sexes were significantly lower at statistical analysis in the high dose group of both sexes compared to controls throughout the study. Food consumption was reduced only in high dose females starting from post coitum Day 14. There were no effect on motor activity, sensory reaction to stimuli, and no neurotoxicity. There were no effect on haematological parameters and on clinical chemistry, and no effect on spermatogenic cycle. Terminal body weight was significantly lower at the statistical analysis in the high dose group of both sexes compared to controls. Statistically significant higher liver and kidneys weight was observed in high dose males and females compared to controls. In addition, a significant increase was also detected in the kidney weight of both sexes in the mid-dose group. At final sacrifice, treatment related changes were seen in the liver and kidneys. Statistically significant treatment-related findings were noted in the liver of the high dosed group of both sexes and in mid-dose male group, consisting of centrilobular hepatocytic hypertrophy associated with cytoplasmic eosinophilia. The change was of mild degree in the high dosed animals, and of minimal degree in the intermediate dose group. As the hepatocytic hypertrophy was not associated with other changes in the hepatocytes (i.e., degeneration and/or necrosis), this change was not considered as adverse, but rather as potentially adaptive. In the kidneys of the males treated with the intermediate and high dose, a dose-related increased incidence of minimal cortical basophilic tubules was noted. As organ weight data indicated a statistically significant increase of the relative kidney weight in these groups, as well as macroscopically cases of enlarged kidneys were seen only in the males treated with the high dose, it is suggested that the dose-related increased incidence of minimal cortical basophilic tubules is potentially related to treatment. On the basis of the results obtained in the study, the NOAEL for general toxicity is 150 mg/kg/day for males and females, based on clinical signs, reduced body weight and body weight gain at 600 mg/kg bw/day (compared to controls). Based on these results, the test substance tert-butyl cumyl peroxide (CAS 3457-60-2) does not have to be classified and has no obligatory labelling requirement for repeated dose toxicity according to the Globally Harmonized System of Classification and Labelling of Chemicals (GHS) of the United Nations (2017) (including all amendments) and Regulation (EC) No 1272/2008 on classification, labelling and packaging of items and mixtures (including all amendments). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/340a0de1-53de-4120-9717-03672f63cc47/documents/8a61f444-f2d4-419e-90e4-6cfd9c968c11_c9edebd7-1ee8-4892-9df3-f9685b1eea6c.html,,,,,, "tert-butyl α,α-dimethylbenzyl peroxide",3457-61-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/340a0de1-53de-4120-9717-03672f63cc47/documents/8a61f444-f2d4-419e-90e4-6cfd9c968c11_c9edebd7-1ee8-4892-9df3-f9685b1eea6c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat "tert-butyl α,α-dimethylbenzyl peroxide",3457-61-2,"Acute oral toxicity Trigonox T (90 -92% tert-butyl cumyl peroxide) was administered by oral route (gavage at 3, 3.6, 4.32, 5.18, 6.22 ml/kg bw) to groups of 10 White Albino rats (5 males, 5 females) (Spanjers and Til, 1977). Animals were then observed for 14 days.3/10 animals died at the lowest dose exposure. 4/10 animals died at 3.6 and at 4.32 ml/kg doses. 5/10 animals died at 5.18 ml/kg and 6/10 animals died at the highest dose. Within one hour after treatment the rats showed sluggishness, decreased activity and slight tremors. After 24 hours wet coats developed in most of the rats and an occasional rat exhibited diarrhoea. Deaths occurred between 8 and 53 hours after dosing. Thereafter, the survivors recovered gradually and looked quite healthy again at the end of the observation period. Macroscopic examination of the survivors revealed baldness of the urogenital region of several rats. At autopsy pale kidneys were seen in some of the males.Under these experimental conditions, the oral LD50 of the test item in rat is 5.18 ml/kg, equivalent to 4870 mg/kg.   Acute inhalation toxicity The acute inhalation toxicity of Trigonox T (90 -92 % w/w of tert-butyl cumyl peroxide) was studied by exposing rats for four hours to an atmosphere containing 140 ppm of the test material, which was the highest concentration attainable (Reuzel and Hendriksma). No mortality occurred. Eye irritatioin and a decreased respiration frequency were observed. The 4-hour LC0 of Trigonox T in rats appeared to be higher than 140 ppm (1.2 mg/L).   Acute dermal toxicity in rats Peroximon 801 (96.8% tert-butyl-cumyl peroxide) was applied to the skin of one group of ten Sprague-Dawley rats (five males and five females), in a well conducted acute dermal toxicity test (OECD 402, GLP) (Manciaux, 1999a). The application was performed with the undiluted test substance at the dose of 2000 mg/kg. The test site was then covered by a semi-occlusive dressing for 24 hours. Clinical signs, mortality and body weight gain were checked for a period of 14 days following the single application of the test substance. All animals were subjected to necropsy. The general behaviour of the animals was not affected by treatment with the test substance. A reduced weight gain or slight bodyweight loss were observed in two females during the observation period. The overall body weight gain of the ether animals was not affected by treatment with the test substance. No cutaneous reactions were observed. No death occurred at 2000 mg/kg. No apparent abnormalities were observed at necropsy. The dermal LD0 of Peroximon 801 was equal to or higher than 2000 mg/kg bw in rats.   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/340a0de1-53de-4120-9717-03672f63cc47/documents/27e7c274-af1f-48db-858b-42fcdc518a66_c9edebd7-1ee8-4892-9df3-f9685b1eea6c.html,,,,,, "tert-butyl α,α-dimethylbenzyl peroxide",3457-61-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/340a0de1-53de-4120-9717-03672f63cc47/documents/27e7c274-af1f-48db-858b-42fcdc518a66_c9edebd7-1ee8-4892-9df3-f9685b1eea6c.html,,oral,LD50,"4,870 mg/kg bw",no adverse effect observed, "tert-butyl α,α-dimethylbenzyl peroxide",3457-61-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/340a0de1-53de-4120-9717-03672f63cc47/documents/27e7c274-af1f-48db-858b-42fcdc518a66_c9edebd7-1ee8-4892-9df3-f9685b1eea6c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "tert-butyl α,α-dimethylbenzyl peroxide",3457-61-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/340a0de1-53de-4120-9717-03672f63cc47/documents/27e7c274-af1f-48db-858b-42fcdc518a66_c9edebd7-1ee8-4892-9df3-f9685b1eea6c.html,,inhalation,discriminating conc.,"1,200 mg/m3",no adverse effect observed, tert-butylamine,75-64-9,"13-week inhalation study in rats (equivalent or similar to OECD TG 413 and performed in accordance with GLP): NOAEC systemic = 0.5 mg/L air, NOAEC local = 0.2 mg/L air. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83846066-b9af-4f07-93a1-aa174b2efc0e/documents/aa49ea1e-a7ea-40f2-a9f5-4dc8e2b8f8a3_0e5a7085-e92b-4e2c-891a-fbfb6c40608c.html,,,,,, tert-butylamine,75-64-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83846066-b9af-4f07-93a1-aa174b2efc0e/documents/aa49ea1e-a7ea-40f2-a9f5-4dc8e2b8f8a3_0e5a7085-e92b-4e2c-891a-fbfb6c40608c.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.5 mg/L,,rat tert-butylamine,75-64-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/83846066-b9af-4f07-93a1-aa174b2efc0e/documents/aa49ea1e-a7ea-40f2-a9f5-4dc8e2b8f8a3_0e5a7085-e92b-4e2c-891a-fbfb6c40608c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.2 mg/L,adverse effect observed,rat tert-butylamine,75-64-9,Acute Toxicity: - oral: LD50: 464 mg/kg bw (rat); - inhalation: 3.8 mg/L air (4h) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83846066-b9af-4f07-93a1-aa174b2efc0e/documents/422bda05-e925-4d77-a17a-f7b4e4cbb020_0e5a7085-e92b-4e2c-891a-fbfb6c40608c.html,,,,,, tert-butylamine,75-64-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83846066-b9af-4f07-93a1-aa174b2efc0e/documents/422bda05-e925-4d77-a17a-f7b4e4cbb020_0e5a7085-e92b-4e2c-891a-fbfb6c40608c.html,,oral,LD50,464 mg/kg bw,adverse effect observed, tert-butylamine,75-64-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/83846066-b9af-4f07-93a1-aa174b2efc0e/documents/422bda05-e925-4d77-a17a-f7b4e4cbb020_0e5a7085-e92b-4e2c-891a-fbfb6c40608c.html,,inhalation,LC50,"3,800 mg/m3",adverse effect observed, tert-dodecanethiol,25103-58-6,"A 4 -week oral study in rats, a 4- and 13-week inhalation studies are available using rats, dogs and/or mice were available on t-dodecyl mercaptan. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): GLP study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): GLP study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The OECD 443 study is considered to be reliable with a klimisch score of 1. In this study, the animals were exposed longer than in the OECD 422 study (16-17 weeks instead of 4 weeks) so the NOAEL of the OECD 443 is more relevant for repeated toxicity endpoint and for DNEL derivations. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12e90d85-dcd4-457e-a1e8-06ad92b15e6a/documents/IUC5-86afa369-f787-4dfb-8847-b6f8cbd27ef0_c608d3bb-d0af-449a-b0b8-42ff1dd2f8ab.html,,,,,, tert-dodecanethiol,25103-58-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12e90d85-dcd4-457e-a1e8-06ad92b15e6a/documents/IUC5-86afa369-f787-4dfb-8847-b6f8cbd27ef0_c608d3bb-d0af-449a-b0b8-42ff1dd2f8ab.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat tert-dodecanethiol,25103-58-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12e90d85-dcd4-457e-a1e8-06ad92b15e6a/documents/IUC5-86afa369-f787-4dfb-8847-b6f8cbd27ef0_c608d3bb-d0af-449a-b0b8-42ff1dd2f8ab.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,207 mg/m3,,rat tert-dodecanethiol,25103-58-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/12e90d85-dcd4-457e-a1e8-06ad92b15e6a/documents/IUC5-86afa369-f787-4dfb-8847-b6f8cbd27ef0_c608d3bb-d0af-449a-b0b8-42ff1dd2f8ab.html,Repeated dose toxicity – local effects,inhalation,NOAEC,795 mg/m3,no adverse effect observed,rat tert-dodecanethiol,25103-58-6,"The potential acute toxicity of tert-dodecane thiol after oral exposure was evaluated in a study conducted in compliance with OECD Guideline No. 423 (CitoxLab, 2017). The oral LD0 of tert-dodecane thiol was higher than 2000 mg/kg in rats. No reliable data is available after single inhalation or dermal exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12e90d85-dcd4-457e-a1e8-06ad92b15e6a/documents/IUC5-40707b04-160f-4682-b599-e54f3abe5040_c608d3bb-d0af-449a-b0b8-42ff1dd2f8ab.html,,,,,, tert-dodecanethiol,25103-58-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/12e90d85-dcd4-457e-a1e8-06ad92b15e6a/documents/IUC5-40707b04-160f-4682-b599-e54f3abe5040_c608d3bb-d0af-449a-b0b8-42ff1dd2f8ab.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, tert-pentyl 2-ethylperoxyhexanoate,686-31-7," Risk assessment was assessed using the results of the 90-day study conducted on the read-across substance CAS# 3006-82-4. The DNELs calcuated using this study were the most conservative of studies available when considering the repeat dose study on the read-across CAS# 3006-82-4 and OECD 421 available on CAS# 686-31-7. CAS# 3006-82-4 Butylperoxy-2-ethylhexanoate at three dose levels over a prolonged period of time (90 days) followed by a 28-day recovery period in order to assess reversibility, persistence or delayed occurrence of potential toxicological effects. The test item was administered orally (by gavage) to Hsd.Brl.Han: Wistar rats (n=15 animals/sex in the control and high dose groups, n= 10 animals/sex in the low and middle dose groups) once a day at 0 (vehicle control), 450, 150 and 70 mg/kg bw/day doses Under the conditions of the present study tert. Butylperoxy-2-ethylhexanoate did not cause adverse effects in male or female Hsd.Brl.Han: Wistar rats after the consecutive 90-day oral (gavage) administration. Based on these observations the No Observed Adverse Effect Level (NOAEL) was determined as follows: 450 mg/kg bw/day for male and female animals. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf44cb72-c792-4da5-b85c-b53241448467/documents/IUC5-8e88eb51-e593-4d7a-b011-5ad1544262bc_47592be8-08f8-4833-be9a-3d7735463e8f.html,,,,,, tert-pentyl 2-ethylperoxyhexanoate,686-31-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cf44cb72-c792-4da5-b85c-b53241448467/documents/IUC5-8e88eb51-e593-4d7a-b011-5ad1544262bc_47592be8-08f8-4833-be9a-3d7735463e8f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat tert-pentyl 2-ethylperoxyhexanoate,686-31-7,"Acute oral toxicity: the oral LD0 of tert-amyl peroxyoctoate is more than 5000 mg/kg in Sprague Dawley rats (Reagan, 1981)Acute dermal toxicity: the dermal LD0 of tert-amyl peroxyoctoate is more than 2000 mg/kg in New-Zealand White rabbits (Reagan, 1981) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf44cb72-c792-4da5-b85c-b53241448467/documents/IUC5-097d59d4-0b45-4a8a-a245-3fa6a32a9fb0_47592be8-08f8-4833-be9a-3d7735463e8f.html,,,,,, tert-pentyl 2-ethylperoxyhexanoate,686-31-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf44cb72-c792-4da5-b85c-b53241448467/documents/IUC5-097d59d4-0b45-4a8a-a245-3fa6a32a9fb0_47592be8-08f8-4833-be9a-3d7735463e8f.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, tert-pentyl 2-ethylperoxyhexanoate,686-31-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cf44cb72-c792-4da5-b85c-b53241448467/documents/IUC5-097d59d4-0b45-4a8a-a245-3fa6a32a9fb0_47592be8-08f8-4833-be9a-3d7735463e8f.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, tert-pentyl hydroperoxide,3425-61-4,"Inhalation exposure to Trigonox TAHP-W85 in the form of a vapour to Wistar rats during a 28-day period at concentration levels of 0.025, 0.103 and 0.405 mg/L for six hours per day, 5 days/wk, was not associated with adverse effects. Slight sneezing was occasionally observed following exposure to 0.405 mg/L in both sexes and was considered related to the irritating properties of the test item. There were no findings noted in bodyweight, food consumption or clinical pathology of animals from exposed groups compared to the control group. No test item-related microscopic findings were noted in any of the examined organs including the respiratory tract and the associated lymph nodes at concentration levels of 0.025, 0.103 and 0.405 mg/L. The No-Observed Adverse Effect Concentration (NOAEC) for Trigonox TAHP-W85 was therefore considered to be at least 0.405 mg/L. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): GLP guideline study Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): GLP guideline study ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6027e5e1-0712-4bdb-8282-0e6603081c2b/documents/48c9c80e-ee88-4482-949f-64244e2d7666_cece0dc2-5f73-4677-b422-5f2f7c70e17e.html,,,,,, tert-pentyl hydroperoxide,3425-61-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6027e5e1-0712-4bdb-8282-0e6603081c2b/documents/48c9c80e-ee88-4482-949f-64244e2d7666_cece0dc2-5f73-4677-b422-5f2f7c70e17e.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,0.405 mg/L,,rat tert-pentyl hydroperoxide,3425-61-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6027e5e1-0712-4bdb-8282-0e6603081c2b/documents/48c9c80e-ee88-4482-949f-64244e2d7666_cece0dc2-5f73-4677-b422-5f2f7c70e17e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,0.337 mg/L,no adverse effect observed,rat tert-pentyl hydroperoxide,3425-61-4,"The oral LD50 of tert-amyl hydroperoxide is 500 mg/kg bw in Sprague Dawley rats (Doubs, 1981); generally between 450 and 864 mg/kg bw in rodents. The dermal LD50 is 446 mg/kg bw in rats (Doubs, 1995). The 4-hour LC50 is 2425 mg/m3 [IC 95: 2100 -2750 mg/m3] (TNO, 1981). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Klimisch 1 study, GLP compliant. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Klimisch 2 study, no data on GLP compliance. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Klimisch 1 study, GLP compliant. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6027e5e1-0712-4bdb-8282-0e6603081c2b/documents/91427e29-21d9-4584-ab05-a480657b93a1_cece0dc2-5f73-4677-b422-5f2f7c70e17e.html,,,,,, tert-pentyl hydroperoxide,3425-61-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6027e5e1-0712-4bdb-8282-0e6603081c2b/documents/91427e29-21d9-4584-ab05-a480657b93a1_cece0dc2-5f73-4677-b422-5f2f7c70e17e.html,,oral,LD50,500 mg/kg bw,adverse effect observed, tert-pentyl hydroperoxide,3425-61-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6027e5e1-0712-4bdb-8282-0e6603081c2b/documents/91427e29-21d9-4584-ab05-a480657b93a1_cece0dc2-5f73-4677-b422-5f2f7c70e17e.html,,dermal,LD50,446 mg/kg bw,adverse effect observed, tert-pentyl hydroperoxide,3425-61-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6027e5e1-0712-4bdb-8282-0e6603081c2b/documents/91427e29-21d9-4584-ab05-a480657b93a1_cece0dc2-5f73-4677-b422-5f2f7c70e17e.html,,inhalation,LC50,"2,425 mg/m3",adverse effect observed, tert-pentyl peroxypivalate,29240-17-3,"Studies are not available for the registered substance. An OECD 422 for a structural analogue is used. For justification see the read across jusitification document in IUCLID, section 13. For tert-butyl peroxypivalate an OECD 422 (combined repeated dose fertility/developmental screening) (50, 150, 310 mg/kg bw/ d) is available (Wistar rats; vehicle sunflower oil). The systemic NOAEL for this study is 150 mg/kg bw/d. Effects observed are: 310mg/kg bw/d salivation (m/f), reduced bodyweight gain (m) and during lactation period (f), reduced food consumption (m/f), increased kidney weights (m), pup mortality (probably related to material tox.), reduced litter weight/weight gain; 150mg/kg bw/d salivation (m/f), reduced food consumption (m/f). 50mg/kg bw/d: no effects observed. Effects on reproductive performance were not observed. The NOAEL for development is 150 mg/kg bw/day based on effects on mean litter weight, mean pup weight and increased extra uterine mortality at the highest dose level. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fca927f7-f1d9-4161-bca4-3ce5c93f89c4/documents/2d84c14a-4719-4f49-8adb-1ee4edbea50a_bef5706f-d99a-48e4-9272-32aa9784c7ad.html,,,,,, tert-pentyl peroxypivalate,29240-17-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fca927f7-f1d9-4161-bca4-3ce5c93f89c4/documents/2d84c14a-4719-4f49-8adb-1ee4edbea50a_bef5706f-d99a-48e4-9272-32aa9784c7ad.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat tert-pentyl peroxypivalate,29240-17-3,Two acute oral toxicity studies are available in which animals were dosed up to 10 g/kg bw. The lowest LD50 from these studies is 4270 mg/kg bw. An acute inhalation toxicity study in rats shows that exposure to Tert-Amyl peroxypivalate at a concentration of 9.5 g/m3 air during four hours did not result in mortality or in any other major sign of intoxication. The dermal LD50 is greater than 2000 mg/kg. Since one death is observed at 2000 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fca927f7-f1d9-4161-bca4-3ce5c93f89c4/documents/eed32873-8784-4de2-a392-e870558e685e_bef5706f-d99a-48e4-9272-32aa9784c7ad.html,,,,,, tert-pentyl peroxypivalate,29240-17-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fca927f7-f1d9-4161-bca4-3ce5c93f89c4/documents/eed32873-8784-4de2-a392-e870558e685e_bef5706f-d99a-48e4-9272-32aa9784c7ad.html,,oral,LD50,"4,270 mg/kg bw",adverse effect observed, tert-pentylbenzene,2049-95-8," The key study for this endpoint is a 28 days study in rat by oral administration (Reliability.1, GLP). - The NOEL is 300 mg/kg bw/day for females based on the high values of TP and albumin, significant prolongation of APTT, high Ca value, mild centrilobular hypertrophy of hepatocytes in the liver and increased liver weight observed at 1000 mg/kg bw/day (these effects are not adverse and reversible after 14 days of recovery). - The NOEL is 100 mg/kg bw/day for males based on the high values of TP, albumin and kidney weight at 300 mg/kg bw/day. In the 1000 mg/kg dose group, the male animals showed the low values of weight gain, rate of weight gain and Cl, high γ-GTP value and increased liver weight (these effects are not adverse and reversible after 14 days of recovery). - The NOAEL is 300 mg/kg bw/day for male and female rats. The histopathological effects on kidneys, which were found for males at 300 mg/kg bw/day, are considered not relevant for humans. The accumulation of protein (hyaline) droplets in the kidney can also explain the increased absolute kidney weight of the males (12 %). The biochemical findings showed a statistically significant increase of total protein (TP) (4,6 %) and albumin (5,1 %) for the male rats but this increase is not very high and was observed for male rats only. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3d70fc9-c275-44e1-99e8-cd5303b38460/documents/f970847f-171d-403d-ba3e-e096a91aea00_ee2b95f1-0bf5-497b-8651-69c9128e455c.html,,,,,, tert-pentylbenzene,2049-95-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c3d70fc9-c275-44e1-99e8-cd5303b38460/documents/f970847f-171d-403d-ba3e-e096a91aea00_ee2b95f1-0bf5-497b-8651-69c9128e455c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat tert-pentylbenzene,2049-95-8, - Acute toxicity by oral route: the oral LD50 value of tertiary-amylbenzene in Wistar rats was established to exceed 2000 mg/kg body weight. - Acute toxicity by inhalation route: no data available. - Acute toxicity by dermal route: no data available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3d70fc9-c275-44e1-99e8-cd5303b38460/documents/7563cb2f-885f-464b-8546-4c471b7eada1_ee2b95f1-0bf5-497b-8651-69c9128e455c.html,,,,,, tert-pentylbenzene,2049-95-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c3d70fc9-c275-44e1-99e8-cd5303b38460/documents/7563cb2f-885f-464b-8546-4c471b7eada1_ee2b95f1-0bf5-497b-8651-69c9128e455c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Tetra(isobutyl)thioperoxydicarbamic acid,3064-73-1," Subchronic NOAEL (oral, rat, male/female): 300 mg/kg bw/day (OECD 408/GLP) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/606e6911-fb36-4930-a171-d95269feef0c/documents/1a759ee2-e643-4182-ae32-0074c3b6816e_df752517-f734-4250-aeb7-cc2f4152e4c9.html,,,,,, Tetra(isobutyl)thioperoxydicarbamic acid,3064-73-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/606e6911-fb36-4930-a171-d95269feef0c/documents/1a759ee2-e643-4182-ae32-0074c3b6816e_df752517-f734-4250-aeb7-cc2f4152e4c9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Tetra(isobutyl)thioperoxydicarbamic acid,3064-73-1, Acute oral toxicity: LD50 (male/female): >2000 mg/kg bw (OECD 423/GLP) Acute inhalational toxicity: LD50 (male/female): > 5 mg/L (4 hrs; nose only; OECD 403/GLP) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/606e6911-fb36-4930-a171-d95269feef0c/documents/2d92842f-9d5f-4389-bb2e-1303adbe2fb1_df752517-f734-4250-aeb7-cc2f4152e4c9.html,,,,,, Tetra(isobutyl)thioperoxydicarbamic acid,3064-73-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/606e6911-fb36-4930-a171-d95269feef0c/documents/2d92842f-9d5f-4389-bb2e-1303adbe2fb1_df752517-f734-4250-aeb7-cc2f4152e4c9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetra(isobutyl)thioperoxydicarbamic acid,3064-73-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/606e6911-fb36-4930-a171-d95269feef0c/documents/2d92842f-9d5f-4389-bb2e-1303adbe2fb1_df752517-f734-4250-aeb7-cc2f4152e4c9.html,,inhalation,LC50,5 mg/m3,no adverse effect observed, tetraammine palladium (II) hydrogen carbonate,134620-00-1," In a GLP guideline study (EU Method B.7) rats were gavaged with tetraamminepalladium(II) hydrogen carbonate for 28 days. A NOAEL of 15 mg/kg bw/day is considered appropriate, based on microscopic changes in the spleen in high-dose (150 mg/kg bw/day) animals (Wragg et al., 1997).   In an OECD Test Guideline 421 reproductive/developmental toxicity screening study, to GLP, in rats with tetraamminepalladium(II) dichloride, the general systemic toxicity NOAEL for males was the lowest tested dose (4 mg/kg bw/day), on the basis of reduced growth at 20 and 100 mg/kg bw/day (Török-Bathó, 2015).   No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0a2839d-81f2-4d84-af3c-f388ad7f9540/documents/c322b122-76dd-4bd7-ae19-a93341f949a1_b6ebd3e5-122d-42b0-8de6-d86248b1ac6d.html,,,,,, tetraammine palladium (II) hydrogen carbonate,134620-00-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0a2839d-81f2-4d84-af3c-f388ad7f9540/documents/c322b122-76dd-4bd7-ae19-a93341f949a1_b6ebd3e5-122d-42b0-8de6-d86248b1ac6d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,4 mg/kg bw/day,,rat tetraammine palladium (II) hydrogen carbonate,134620-00-1," In an OECD guideline study, the acute oral LD50 of tetraamminepalladium(II) hydrogen carbonate in the female rat was reported to be 933 mg/kg bw (Allen, 1995a).   In an OECD guideline study, to GLP, the acute dermal LD50 of tetraamminepalladium(II) hydrogen carbonate was found to be greater than 2000 mg/kg bw in rats, as no deaths occurred at this limit dose (Allen, 1997a).   No relevant acute inhalation toxicity data were identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0a2839d-81f2-4d84-af3c-f388ad7f9540/documents/df8503a1-88d1-4079-a623-7a44e1049693_b6ebd3e5-122d-42b0-8de6-d86248b1ac6d.html,,,,,, tetraammine palladium (II) hydrogen carbonate,134620-00-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0a2839d-81f2-4d84-af3c-f388ad7f9540/documents/df8503a1-88d1-4079-a623-7a44e1049693_b6ebd3e5-122d-42b0-8de6-d86248b1ac6d.html,,oral,LD50,933 mg/kg bw,adverse effect observed, tetraammine platinum (II) hydrogen carbonate,123439-82-7," In a guideline study, to GLP, daily oral (gavage) administration of tetraammineplatinum(II) hydrogen carbonate to rats for 28 days had effects at doses of 150 and 300 mg/kg bw/day. With the exception of reduced absolute brain weights in high-dose males, these effects were not considered to be toxicologically significant. A NOAEL of 150 mg/kg bw/day was established (Wragg et al., 1997).   In an OECD Test Guideline 421 reproductive/developmental toxicity screening study, to GLP, in rats with tetraammineplatinum(II) dinitrate, the general systemic toxicity NOAEL for females was 250 mg/kg bw/day on the basis of reduced growth at the highest tested dose (1000 mg/kg bw/day). No adverse effects were observed in males at any dose (Hansen, 2015).   No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c054eb32-116e-4b91-bc59-d3a2635312f8/documents/c2306837-4ca4-4567-a57e-7f7fe7f5b398_e0494f99-e9b2-4eb7-8071-4dd023dc86ba.html,,,,,, tetraammine platinum (II) hydrogen carbonate,123439-82-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c054eb32-116e-4b91-bc59-d3a2635312f8/documents/c2306837-4ca4-4567-a57e-7f7fe7f5b398_e0494f99-e9b2-4eb7-8071-4dd023dc86ba.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat tetraammine platinum (II) hydrogen carbonate,123439-82-7," The acute oral LD50 value of tetraammineplatinum(II) hydrogen carbonate was determined to exceed 2150 mg/kg bw in 5 male and 5 female rats (Berthold, 1997a). In an earlier rat study, the acute oral LD50 value of tetraammineplatinum(II) hydrogen carbonate was determined to be >200 mg/kg bw (in the main study; 5/sex) but <2000 mg/kg bw (in the range-finder; 1 sex/dose). No evidence of systemic toxicity was observed at the limit dose of 200 mg/kg bw in the main study (Dreher, 1989).   In an OECD guideline study, to GLP, the acute dermal LD50 value (24-hour semi-occlusive application) for tetraammineplatinum(II) hydrogen carbonate was >2000 mg/kg bw in rats (Allen, 1997).   No relevant acute inhalation toxicity data were identified (or are required). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c054eb32-116e-4b91-bc59-d3a2635312f8/documents/95e2a543-0b4e-41bd-9482-4469939a99ad_e0494f99-e9b2-4eb7-8071-4dd023dc86ba.html,,,,,, tetraammine platinum (II) hydrogen carbonate,123439-82-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c054eb32-116e-4b91-bc59-d3a2635312f8/documents/95e2a543-0b4e-41bd-9482-4469939a99ad_e0494f99-e9b2-4eb7-8071-4dd023dc86ba.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, Tetraamminepalladium(2+) diacetate,61495-96-3," In an OECD Test Guideline 421 reproductive/developmental toxicity screening study, to GLP, in rats with tetraamminepalladium dichloride, the general systemic toxicity NOAEL for males was the lowest tested dose (4 mg/kg bw/day), on the basis of reduced growth at 20 and 100 mg/kg bw/day (Török-Bathó, 2015). The critical oral NOAEL for tetraamminepalladium dichloride (4 mg/kg bw/day) equates to NOAELs of 1.76 and 5.45 mg/kg bw/day for palladium and tetraamminepalladium diacetate, respectively (based on MWt ratios). In a GLP guideline study (EU Method B.7), rats were gavaged with tetraamminepalladium hydrogen carbonate for 28 days. A NOAEL of 15 mg/kg bw/day was obtained based on microscopic changes in the spleen in high-dose animals (150 mg/kg bw/day) (Wragg et al., 1997). No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7855d03a-87b0-43a3-a384-88087e77995d/documents/IUC5-28e7741b-813b-4bcc-a6cc-04891fb78fa9_d57b598c-8aff-438f-abb2-f4e3b136772d.html,,,,,, Tetraamminepalladium(2+) diacetate,61495-96-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7855d03a-87b0-43a3-a384-88087e77995d/documents/IUC5-28e7741b-813b-4bcc-a6cc-04891fb78fa9_d57b598c-8aff-438f-abb2-f4e3b136772d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,4 mg/kg bw/day,,rat Tetraamminepalladium(2+) diacetate,61495-96-3," In an OECD guideline study, the acute oral LD50 of tetraamminepalladium hydrogen carbonate in female rats was reported to be 933 mg/kg bw (Allen, 1995a). In an OECD guideline study, to GLP, the acute dermal LD50 of tetraamminepalladium hydrogen carbonate was found to be greater than 2000 mg/kg bw, as no deaths occurred at this limit dose (Allen, 1997a). No relevant acute inhalation toxicity data were identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7855d03a-87b0-43a3-a384-88087e77995d/documents/IUC5-5b70bcf2-94ba-4c28-8e1c-9aa403c49eed_d57b598c-8aff-438f-abb2-f4e3b136772d.html,,,,,, Tetraamminepalladium(2+) diacetate,61495-96-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7855d03a-87b0-43a3-a384-88087e77995d/documents/IUC5-5b70bcf2-94ba-4c28-8e1c-9aa403c49eed_d57b598c-8aff-438f-abb2-f4e3b136772d.html,,oral,LD50,933 mg/kg bw,adverse effect observed, Tetraamminepalladium(2+) dichloride,13815-17-3," In an OECD Test Guideline 421 reproductive/developmental toxicity screening study, to GLP, in rats with tetraamminepalladium dichloride, the general systemic toxicity NOAEL for males was the lowest tested dose (4 mg/kg bw/day), on the basis of reduced growth at 20 and 100 mg/kg bw/day (Török-Bathó, 2015). The critical oral NOAEL for tetraamminepalladium dichloride (4 mg/kg bw/day) equates to an NOAEL of 1.76 mg/kg bw/day for palladium (based on MWt ratio). In a GLP guideline study (EU Method B.7), rats were gavaged with tetraamminepalladium hydrogen carbonate for 28 days. A NOAEL of 15 mg/kg bw/day was obtained based on microscopic changes in the spleen in high-dose animals (150 mg/kg bw/day) (Wragg et al., 1997). No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b9f085a-9284-4924-83ee-eb1e2d98b93c/documents/IUC5-cc4c19e5-62e8-4866-9955-60c23616bd7b_76860dfe-698d-4477-b581-a8feaa105652.html,,,,,, Tetraamminepalladium(2+) dichloride,13815-17-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b9f085a-9284-4924-83ee-eb1e2d98b93c/documents/IUC5-cc4c19e5-62e8-4866-9955-60c23616bd7b_76860dfe-698d-4477-b581-a8feaa105652.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,4 mg/kg bw/day,,rat Tetraamminepalladium(2+) dichloride,13815-17-3," In an OECD guideline study, the acute oral LD50 of tetraamminepalladium hydrogen carbonate in the female rat was reported to be 933 mg/kg bw (Allen, 1995). In an OECD guideline study, to GLP, the acute dermal LD50 of tetraamminepalladium hydrogen carbonate was found to be greater than 2000 mg/kg bw, as no deaths occurred at this limit dose (Allen, 1997). No relevant acute inhalation toxicity data were identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b9f085a-9284-4924-83ee-eb1e2d98b93c/documents/IUC5-f63c0cfc-0f20-45fe-95d2-a215503ea51b_76860dfe-698d-4477-b581-a8feaa105652.html,,,,,, Tetraamminepalladium(2+) dichloride,13815-17-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b9f085a-9284-4924-83ee-eb1e2d98b93c/documents/IUC5-f63c0cfc-0f20-45fe-95d2-a215503ea51b_76860dfe-698d-4477-b581-a8feaa105652.html,,oral,LD50,933 mg/kg bw,adverse effect observed, Tetraamminepalladium(2+) dinitrate,13601-08-6,"No relevant acute toxicity data were identified for tetraamminepalladium (II) nitrate. As a health precautionary approach, read-across from the structurally-related compound tetraamminepalladium hydrogen carbonate was considered appropriate in order to inform the potential toxicity and classification for tetraamminepalladium (II) nitrate.In an OECD guideline study, the acute oral LD50 of tetraamminepalladium hydrogen carbonate in female rats was reported to be 933 mg/kg bw (Allen, 1995).Tetraamminepalladium hydrogen carbonate is closely related to tetraamminepalladium (II) nitrate and is considered a suitable surrogate for read-across for this endpoint. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f14483e8-6660-4812-879b-f3c03448391f/documents/IUC5-05c53b36-d99c-4c16-a40b-316b06262b0f_c3615cef-c547-4895-9473-f7a4eb06db44.html,,,,,, Tetraamminepalladium(2+) dinitrate,13601-08-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f14483e8-6660-4812-879b-f3c03448391f/documents/IUC5-05c53b36-d99c-4c16-a40b-316b06262b0f_c3615cef-c547-4895-9473-f7a4eb06db44.html,,oral,LD50,933 mg/kg bw,adverse effect observed, Tetraammineplatinum dichloride,13933-32-9,"The acute oral LD50 value of tetraammineplatinum dichloride was reported to exceed 15.1 g/kg bw in rats (Jones, 1977a).In rats, the acute dermal LD50 value (24-hour semi-occlusive application) for tetraammineplatinum hydrogen carbonate was >2000 mg/kg bw (Allen, 1977).No relevant acute inhalation toxicity data were identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cc04a08-81e6-46cc-845e-b78632fcde67/documents/IUC5-203f1e5e-c5ef-4f8a-ac51-7df6a9d95d49_d8d1a00a-a5f3-4a84-91b5-f701e917a87d.html,,,,,, Tetraammineplatinum dichloride,13933-32-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cc04a08-81e6-46cc-845e-b78632fcde67/documents/IUC5-203f1e5e-c5ef-4f8a-ac51-7df6a9d95d49_d8d1a00a-a5f3-4a84-91b5-f701e917a87d.html,,oral,LD50,"15,100 mg/kg bw",no adverse effect observed, Tetraammineplatinum dichloride,13933-32-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5cc04a08-81e6-46cc-845e-b78632fcde67/documents/IUC5-203f1e5e-c5ef-4f8a-ac51-7df6a9d95d49_d8d1a00a-a5f3-4a84-91b5-f701e917a87d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetraammineplatinum dinitrate,20634-12-2," In an OECD Test Guideline 421 reproductive/developmental toxicity screening study, to GLP, in rats with tetraammineplatinum dinitrate, the general systemic toxicity NOAEL for females was 250 mg/kg bw/day on the basis of reduced growth at the highest tested dose (1000 mg/kg bw/day). No adverse effects were observed in males at any dose (Hansen, 2015).   No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required.     ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/543cf69c-fa13-4f20-87d0-847054341343/documents/70de1025-6600-4901-85b3-262b33ec26f5_8ba62352-502e-4413-b0bb-755112b4e1da.html,,,,,, Tetraammineplatinum dinitrate,20634-12-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/543cf69c-fa13-4f20-87d0-847054341343/documents/70de1025-6600-4901-85b3-262b33ec26f5_8ba62352-502e-4413-b0bb-755112b4e1da.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Tetraammineplatinum dinitrate,20634-12-2," No relevant acute toxicity data were identified for tetraammineplatinum dinitrate.   In a reliable guideline GLP study, the acute oral LD50 value of tetraammineplatinum hydrogen carbonate was determined to exceed 2150 mg/kg bw in rats (5/sex/dose) (Berthold, 1997). In an earlier rat study, the acute oral LD50 value of tetraammineplatinum hydrogen carbonate was determined to be >200 mg/kg bw but <2000 mg/kg bw. No evidence of systemic toxicity was observed at the dose of 200 mg/kg bw in the main study (5/sex/dose) but both tested animals (1/sex) died in the range-finder at 2000 mg/kg bw/day (Dreher, 1989). The acute oral LD50 value of tetraammineplatinum dichloride was reported to exceed 15 g/kg bw in rats (Jones, 1977a).   In a guideline study, to GLP, the acute dermal LD50 value of tetraammineplatinum diacetate, following 24-hour occlusive application in rats, was reported to exceed 2000 mg/kg bw (Beerens-Heijnen, 2006). In rats, the acute dermal LD50 value (24-hour semi-occlusive application) for tetraammineplatinum hydrogen carbonate was >2000 mg/kg bw(Allen, 1997).   No relevant acute inhalation toxicity data were identified, or are required at this tonnage. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/543cf69c-fa13-4f20-87d0-847054341343/documents/51d3cb0f-9c31-4f85-b2fe-5ab52ec6dd85_8ba62352-502e-4413-b0bb-755112b4e1da.html,,,,,, Tetraamminezinc(2+) carbonate,38714-47-5, Oral: A study according OECD TG 423 was performed and the acute oral LD50 was calculated to be > 2000 mg/ kg bw in female Wistar rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63184b26-0f64-4020-87e2-d1cbe2274f5f/documents/453433d9-9e43-47f3-9ec0-d775f9c76f1b_040a9512-440e-4528-8128-efbf4d1165b5.html,,,,,, Tetraamminezinc(2+) carbonate,38714-47-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/63184b26-0f64-4020-87e2-d1cbe2274f5f/documents/453433d9-9e43-47f3-9ec0-d775f9c76f1b_040a9512-440e-4528-8128-efbf4d1165b5.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Tetraammonium decachloro-μ-oxodiruthenate(4-),85392-65-0," In an OECD Test Guideline 422 combined repeated dose and reproductive/developmental toxicity screening study in rats, involving the gavage administration of tetraammonium-decachloro-mu-oxodiruthenate for at least 34 days, no clinical signs of toxicity or any adverse pathological or histopathological effects were observed at up to 300 mg/kg bw/day (Hansen, 2017).   No repeated dose toxicity studies by the inhalation or dermal route were identified, or are required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/660d7ed8-f9fe-4a0a-96f5-4feafe82cd6e/documents/00a85d05-0025-4736-b485-811282c1a052_c2a04814-0ee5-4018-8c4a-5098c6793448.html,,,,,, Tetraammonium decachloro-μ-oxodiruthenate(4-),85392-65-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/660d7ed8-f9fe-4a0a-96f5-4feafe82cd6e/documents/00a85d05-0025-4736-b485-811282c1a052_c2a04814-0ee5-4018-8c4a-5098c6793448.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Tetraammonium decachloro-μ-oxodiruthenate(4-),85392-65-0," In an OECD guideline GLP study, the acute oral LD50 value for tetraammonium decachloro-mu-oxodiruthenate was calculated to be 3110 mg/kg bw following gavage administration in female rats (Haferkorn, 2016).   No relevant acute dermal or inhalation toxicity data were identified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/660d7ed8-f9fe-4a0a-96f5-4feafe82cd6e/documents/25ba6c4b-a6df-4a67-a8fc-bdb69e2cde87_c2a04814-0ee5-4018-8c4a-5098c6793448.html,,,,,, Tetraammonium decachloro-μ-oxodiruthenate(4-),85392-65-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/660d7ed8-f9fe-4a0a-96f5-4feafe82cd6e/documents/25ba6c4b-a6df-4a67-a8fc-bdb69e2cde87_c2a04814-0ee5-4018-8c4a-5098c6793448.html,,oral,LD50,"3,110 mg/kg bw",no adverse effect observed, Tetraammonium ethylenediaminetetraacetate,22473-78-5,"There are no repeated dose studies with tetraammonium EDTA available. However, under physiological conditions (pH 7-9) any EDTA salt as well as edetic acid will dissociate into the cations and the respective anionic species of edetic acid depending on the dissociation equilibria of edetic acid. Under the assumption of this equivalence it is likely that all EDTA salt chelate ions in vivo. Therefore repeated dose studies with other EDTA-salts, such as Na2EDTA and Na3EDTA, have been used as read across. (For read-across justification refer to section 13).A 90 day (Na2EDTA) as well as a 2 years (Na3EDTA) feeding study on rats provide reliable toxicological information for an overall NOAEL of about 500 mg/kg bw.A NOAEC value of 3 mg/m³ air was established in a subchronic toxicity study with Na2H2EDTA.It can also be ruled out that at this concentrations ammonium ions may cause any toxic effect, as ammonium ions are converted to urea in the liver or are utilized to form in amino acids and proteins. There is only a limited number on repeated dose studies with other ammonium salts available, however oral studies on rats with NH4Cl or ammonium sulfate report even higher NOAELs. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0346611-9e0a-4ea8-9ab9-09e06d1c34de/documents/IUC5-f5a22c51-574e-466f-8068-1eb425b39618_94e6226f-34eb-4877-84a9-9405fc0f3c6c.html,,,,,, Tetraammonium ethylenediaminetetraacetate,22473-78-5,"The acute oral toxicity data of Na4 EDTA have been used for a estimation of the acute oral toxicity of Tetraammonium EDTA since the pH and not only EDTA may influence the acute toxicity to a certian extend. The pH of Na4EDTA (pH = 10.5-12.5) is almost similar with the pH value of Tetraammonium EDTA ( pH = 9.0 - 9.5), so that a read-across is justified. (For read-across justification also refer to section 13)The oral LD50 value established for Na4EDTA is 1780 and 1913 mg/kg bw for females and males, respectively (BASF, 1983). Concerning the fact, that the test substance Tetraammonium EDTA is a 50 % dilution in water and the pH value is even more neutral it is likely that its LD 50 would exceed a value of 2000 mg/kg bw. This assumption is in line with the results of a range finder study with the test substance itself where a LD 50 value of > 3940 mg/kg bw is reported. The LOAEC established in an inhalation study with Na2EDTAwas considered to be 30 mg/m³ air.Furthermore it is highly unlikely that EDTA induced acute dermal toxicity as neither Ca or Na salts of EDTA are able to penetrate the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0346611-9e0a-4ea8-9ab9-09e06d1c34de/documents/IUC5-d39e0bbe-c041-4a58-a363-4c3447fdeb75_94e6226f-34eb-4877-84a9-9405fc0f3c6c.html,,,,,, Tetraammonium hexamolybdate,12411-64-2,"NOAEL for systemic toxicity, oral, from a sub-chronic study with sodium molybdate dihydrate in rats (Hoffman, 2011): 17 mg Mo/kg bw/day. Unbounded NOAEC for systemic toxicity, inhalation, from a sub-chronic study with molybdenum trioxide in rats and mice (NTP, 1997): 66.7 mg Mo/m³. Important: both values expressed based on element Mo (for read-across purposes), not on the respective test substance. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Important: NOAEL based on element Mo, not on a specific molybdenum substance! ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/99cfb32d-04fe-490d-ae53-51f376188c14/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_da2c5fd5-9305-4360-9a53-32713dcb4271.html,,,,,, Tetraammonium hexamolybdate,12411-64-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/99cfb32d-04fe-490d-ae53-51f376188c14/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_da2c5fd5-9305-4360-9a53-32713dcb4271.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,17 mg/kg bw/day,,rat Tetraammonium hexamolybdate,12411-64-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/99cfb32d-04fe-490d-ae53-51f376188c14/documents/IUC5-15d38f7d-35df-40b6-8790-c0ae5408cabe_da2c5fd5-9305-4360-9a53-32713dcb4271.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,66.7 mg/m3,,other:rats and mice Tetraammonium hexamolybdate,12411-64-2," To avoid unnecessary (animal) testing, a comprehensive grouping and read-across concept has been developed amongst several molybdenum containing substances. Acute oral, inhalation and dermal toxicity studies are available for several but not all substances in the category. The following LD50s are therefore either based on test data for the substance in this dossier, or based on read-across within the category: For ammonium octamolybdate: LD50 oral: > 2000 mg/kg  (estimated, based on category read-across) LD50 inhalation, 4h: > 5 g/m³ (estimated, based on category read-across) LD50 dermal: > 2000 mg/kg (estimated, based on category read-across) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/99cfb32d-04fe-490d-ae53-51f376188c14/documents/IUC5-2a1b1af7-f3e8-407c-9c87-b57a9b6fd4e5_da2c5fd5-9305-4360-9a53-32713dcb4271.html,,,,,, Tetrabismuth triorthosilicate,14708-87-3,"Repeated dose toxicity. Oral route. Read across approach. An OECD 408 Repeat dose toxicity oral 90-day study in rats was conducted with bismuth subnitrate. Groups of male and female rats were treated daily by oral gavage at dose levels of 0 (control), 40, 200 or 1000 mg/kg/day which were dose levels based on a previous 28-day study in rats. Overall, all three dose levels were well tolerated and it was considered that a dose level of 1000 mg/kg/day could be assigned the No Observed Adverse Effect Level (NOAEL). Based on read across from the analogue bismuth subnitrate, the target substance tetrabismuth triorthosilicate can be considered to have a NOAEL = 760.7 mg/kg bw/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): The study was conducted via intratracheal dosing of the test substance suspension, therefore, the dose levels administered do not exactly reflect the inhalation exposure and are quoted in terms of mg/kg body weight. Dosing was undertaken on one occasion per week for 13 weeks since the potential for bismuth accumulation in the lung was a potential hazard. Consequently, the study has been assigned a Klimisch 3 (unreliable) assessment but is considered useful supporting information. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The study was conducted via intratracheal dosing of the test substance suspension, therefore, the dose levels administered do not exactly reflect the inhalation exposure and are quoted in terms of mg/kg body weight. Dosing was undertaken on one occasion per week for 13 weeks since the potential for bismuth accumulation in the lung was a potential hazard. Consequently, the study has been assigned a Klimisch 3 (unreliable) assessment but is considered useful supporting information. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Regulatory toxicity study conducted to GLP ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1585377f-7df1-4610-bc06-f947f4d253d9/documents/fbfc230d-e28d-4846-a614-0c96a583f44f_95beeab7-d865-4828-b1d8-31e209ae3136.html,,,,,, Tetrabismuth triorthosilicate,14708-87-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1585377f-7df1-4610-bc06-f947f4d253d9/documents/fbfc230d-e28d-4846-a614-0c96a583f44f_95beeab7-d865-4828-b1d8-31e209ae3136.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,760.7 mg/kg bw/day,,rat Tetrabismuth triorthosilicate,14708-87-3," REACH Annex VII column 2 states that testing by the inhalation route is appropriate if exposure of humans via inhalation is likely. Forming insoluble particulate matter, the inhalation route was considered the most appropriate exposure pathway for bismuth silicate. A reliable (Klimisch 1), GLP compliant, OECD Guideline 436 study was conducted for the test item (Haferkorn 2016). CD/Crl(SD) rats (3 male; 3 female) were exposed to an aerosol dust of bismuth silicate at a gravimetrically determined concentration of 5.07±0.01 mg/L air for 4 hours by inhalation, via nose-only exposure. The dust particles had a Mass Median Aerodynamic Diameter (MMAD) of 1.617 µm and a Geometric Standard Deviation (GSD) of 2.14. Under the present test conditions, 4-hour inhalation exposure induced slight dyspnoea until 3 hours post exposure in all rats. No other clinical signs of toxicity, mortality or pathological changes at necropsy, were observed in the treated rats. Under the present test conditions, the LC50 value for rats following inhalation of bismuth silicate for 4 hours was determined as >5.07 mg/L air. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1585377f-7df1-4610-bc06-f947f4d253d9/documents/d95acfe4-456d-44e9-a61b-605b7afffd70_95beeab7-d865-4828-b1d8-31e209ae3136.html,,,,,, Tetrabismuth triorthosilicate,14708-87-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1585377f-7df1-4610-bc06-f947f4d253d9/documents/d95acfe4-456d-44e9-a61b-605b7afffd70_95beeab7-d865-4828-b1d8-31e209ae3136.html,,inhalation,LC50,5.07 mg/L,no adverse effect observed, Tetrabromophthalic anhydride,632-79-1,"TBPA: 28 D rabbit dermal; 21 D rat inhalationTCPA (tetrachlorophthalic anhydride): 13 Wk rat gavage, 13 WK mouse gavage ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54ebe278-551b-48bf-ba2a-42c7c70c32fc/documents/IUC5-e728f8bd-38d9-41a2-9c3f-0c70d3df4910_c1476de9-b17e-4ed0-ae70-1e8373b9120f.html,,,,,, Tetrabromophthalic anhydride,632-79-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54ebe278-551b-48bf-ba2a-42c7c70c32fc/documents/IUC5-e728f8bd-38d9-41a2-9c3f-0c70d3df4910_c1476de9-b17e-4ed0-ae70-1e8373b9120f.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,94 mg/kg bw/day,,rat Tetrabromophthalic anhydride,632-79-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54ebe278-551b-48bf-ba2a-42c7c70c32fc/documents/IUC5-e728f8bd-38d9-41a2-9c3f-0c70d3df4910_c1476de9-b17e-4ed0-ae70-1e8373b9120f.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,500 mg/kg bw/day,,rabbit Tetrabromophthalic anhydride,632-79-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54ebe278-551b-48bf-ba2a-42c7c70c32fc/documents/IUC5-e728f8bd-38d9-41a2-9c3f-0c70d3df4910_c1476de9-b17e-4ed0-ae70-1e8373b9120f.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"2,000 mg/m3",,rat Tetrabromophthalic anhydride,632-79-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): K2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): K2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): K2 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54ebe278-551b-48bf-ba2a-42c7c70c32fc/documents/IUC5-b7922c39-bbfd-487e-91d9-e7ee5ac3c1d2_c1476de9-b17e-4ed0-ae70-1e8373b9120f.html,,,,,, Tetrabromophthalic anhydride,632-79-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54ebe278-551b-48bf-ba2a-42c7c70c32fc/documents/IUC5-b7922c39-bbfd-487e-91d9-e7ee5ac3c1d2_c1476de9-b17e-4ed0-ae70-1e8373b9120f.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, Tetrabromophthalic anhydride,632-79-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54ebe278-551b-48bf-ba2a-42c7c70c32fc/documents/IUC5-b7922c39-bbfd-487e-91d9-e7ee5ac3c1d2_c1476de9-b17e-4ed0-ae70-1e8373b9120f.html,,dermal,LD50,"10,000 mg/kg bw",no adverse effect observed, Tetrabromophthalic anhydride,632-79-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54ebe278-551b-48bf-ba2a-42c7c70c32fc/documents/IUC5-b7922c39-bbfd-487e-91d9-e7ee5ac3c1d2_c1476de9-b17e-4ed0-ae70-1e8373b9120f.html,,inhalation,LC50,"2,000 mg/m3",no adverse effect observed, Tetrabutylammonium hydrogen sulphate,32503-27-8," Estimated LD50 was considered to be 1261 mg/kg bw when rat were treated with N,N,N-tributylbutan-1-aminium hydrogen sulfate orally for24 hours. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6b5b8a0-e8d6-472d-8328-c0b08b092d55/documents/1c8a532e-3f10-42c3-97d0-0f0fee542d58_70075ca6-4cb1-4296-847e-49f25b9caeeb.html,,,,,, Tetrabutylammonium hydrogen sulphate,32503-27-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6b5b8a0-e8d6-472d-8328-c0b08b092d55/documents/1c8a532e-3f10-42c3-97d0-0f0fee542d58_70075ca6-4cb1-4296-847e-49f25b9caeeb.html,,oral,LD50,"1,261 mg/kg bw",adverse effect observed, Tetrabutylammonium hydroxide,2052-49-5," Repeated dose toxcity: Oral Based on the available results and applying the weight of evidence approach, the NOAEL for the test chemical can be considered to lie between 40-180 mg/kg/day. Repeated dose toxicity: Inhalation A short term toxicity study does not need to be conducted because exposure of humans via inhalation route is highly unlikely based on the thorough and rigorous exposure assessment. The test chemical has very low vapor pressure of 2.61E-10 Pa which is equivalent to 1.96E-12 mm Hg at 25 ° C, so the potential for the generation of inhalable vapour is low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and therefore this end point was considered for waiver Repeated dose toxicity: Dermal A short term toxicity study does not need to be conducted because exposure of humans via inhalation route is highly unlikely based on the thorough and rigorous exposure assessment. In accordance with ANNEX VII Colum 2 of the REACH regulation, the study need not be conducted if the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5). The experimental pH of the test chemical is 14. Hence, based on the high pH of the test chemical, the repeated dermal toxicity study was considered for waiver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c692a116-e6b2-4035-8661-f227d475f489/documents/3e06c8c2-d31d-48fa-a868-350b631c2c62_b4ebdd51-7550-409e-8a18-fdd8b077af12.html,,,,,, Tetrabutylammonium hydroxide,2052-49-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c692a116-e6b2-4035-8661-f227d475f489/documents/3e06c8c2-d31d-48fa-a868-350b631c2c62_b4ebdd51-7550-409e-8a18-fdd8b077af12.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Tetrabutylammonium hydroxide,2052-49-5," Acute Toxicity: Oral Based on the available results and applying the weight of evidence approach, the acute oral median lethal dose for the test chemical can be considered to lie between 300-2000 mg/kg. Thus by considering the CLP criteria for acute toxicity rating for the chemicals, the test chemical can be classified under the category “Category 4”. Acute toxicity: inhalation The study doesnot need to be conducted due to the low vapor pressure of the chemical and its exposure as aerosols, dusts, mists or vapors of inhalable size during manufacture/use is highly unlikely. The test chemical has very low vapor pressure of 2.61E-10 Pa which is equivalent to 1.96E-12 mm Hg at 25 ° C, so the potential for the generation of inhalable vapour is low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur, and therefore this end point was considered for waiver Acute toxicity: dermal The study neednot be conducted as the substance is classified as corrosive to skin. In accordance with ANNEX VII Colum 2 of the REACH regulation, the study need not be conducted if the substance is a strong acid (pH<=2.0) or strong base (pH=> 11.5). The experimental pH of the test chemical was 14. Hence, based on the high pH of the test chemical, the acute dermal toxicity study was considered for waiver. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c692a116-e6b2-4035-8661-f227d475f489/documents/60731eee-c4ce-4fd9-b9bb-af4b863bb837_b4ebdd51-7550-409e-8a18-fdd8b077af12.html,,,,,, Tetrabutylammonium hydroxide,2052-49-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c692a116-e6b2-4035-8661-f227d475f489/documents/60731eee-c4ce-4fd9-b9bb-af4b863bb837_b4ebdd51-7550-409e-8a18-fdd8b077af12.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, Tetrabutylphosphonium bromide,3115-68-2," In a reliable oral repeated dose toxicity study with reproduction/developmental toxicity screening test according to OECD 422 guideline (July 2015) and performed in accordance with GLP principles, a NOAEL for systemic effects of 100 mg/kg bw/day was derived. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08547287-f28f-4ede-adfa-b3dc6e190395/documents/b9690390-0d92-44fc-98bd-c286eaa92ca2_bcd7754e-b3a3-4697-816e-113971c6644b.html,,,,,, Tetrabutylphosphonium bromide,3115-68-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/08547287-f28f-4ede-adfa-b3dc6e190395/documents/b9690390-0d92-44fc-98bd-c286eaa92ca2_bcd7754e-b3a3-4697-816e-113971c6644b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Tetrabutylphosphonium bromide,3115-68-2," In a reliable acute oral toxicity study performed according to OECD 423 and according to GLP principles, the LD50 cut-off value was determined to be 500 mg/kg bw and in a reliable acute dermal toxicity study performed similar to OECD 402 and according to GLP principles, the LD50 was determined to be >500 and <1000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08547287-f28f-4ede-adfa-b3dc6e190395/documents/b4e77940-ab12-4782-aa62-4c54624dc08d_bcd7754e-b3a3-4697-816e-113971c6644b.html,,,,,, Tetrabutylphosphonium bromide,3115-68-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08547287-f28f-4ede-adfa-b3dc6e190395/documents/b4e77940-ab12-4782-aa62-4c54624dc08d_bcd7754e-b3a3-4697-816e-113971c6644b.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Tetrabutylphosphonium bromide,3115-68-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/08547287-f28f-4ede-adfa-b3dc6e190395/documents/b4e77940-ab12-4782-aa62-4c54624dc08d_bcd7754e-b3a3-4697-816e-113971c6644b.html,,dermal,LD50,500 mg/kg bw,adverse effect observed, Tetrabutylphosphonium chloride,2304-30-5," In a reliable acute oral toxicity study performed according to OECD 423 and according to GLP principles on the analogue substance, the LD50 cut-off value was determined to be 500 mg/kg bw   In two acute inhalation toxicity tests performed accord to the US EPA OPPTS 870.1300, the LC50 was for 1h > 0.04 mg/L and for 4h < 0.05 mg/L   The LD50 for acute dermal exposure with the ethylene carbonate vehicle was 500-600 mg/kg. However, the LD50 by acute dermal exposure of undiluted compound was 225 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74da8b54-4471-4d34-bfc5-8db75eb13bd3/documents/c5e25c62-1a9d-478a-8697-06ee82e7ab0c_9bbadcfc-dbaf-4d5b-866c-2bba8e8909da.html,,,,,, Tetrabutylphosphonium chloride,2304-30-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74da8b54-4471-4d34-bfc5-8db75eb13bd3/documents/c5e25c62-1a9d-478a-8697-06ee82e7ab0c_9bbadcfc-dbaf-4d5b-866c-2bba8e8909da.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Tetrabutylphosphonium chloride,2304-30-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74da8b54-4471-4d34-bfc5-8db75eb13bd3/documents/c5e25c62-1a9d-478a-8697-06ee82e7ab0c_9bbadcfc-dbaf-4d5b-866c-2bba8e8909da.html,,dermal,LD50,225 mg/kg bw,adverse effect observed, Tetrabutylphosphonium chloride,2304-30-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/74da8b54-4471-4d34-bfc5-8db75eb13bd3/documents/c5e25c62-1a9d-478a-8697-06ee82e7ab0c_9bbadcfc-dbaf-4d5b-866c-2bba8e8909da.html,,inhalation,LC50,50 mg/m3,adverse effect observed, Tetrabutylthioperoxydicarbamic acid,1634-02-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9110a29d-5b53-48c1-afe3-3d130161f788/documents/bf968350-2c2e-428b-99b8-1e6f966b7ba9_1bbe6ff0-31ab-46d9-b489-d5ba34392f34.html,,oral,LD50,"2,350 mg/kg bw",no adverse effect observed, Tetrabutylurea,4559-86-8,"The NOAEL of 27 mg/cm2 was calculated from an applied dose of 110 mg/kg bw/d, which has been distributed over a surface area of approximately 4 cm2. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/619b0ea8-9356-4d6a-9836-92e3912e900a/documents/IUC5-83fe4c9d-1fa8-4d37-8fa3-348bf0c68bcc_66c43e74-2511-4cdb-a099-fc176673ce02.html,,,,,, Tetrabutylurea,4559-86-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/619b0ea8-9356-4d6a-9836-92e3912e900a/documents/IUC5-83fe4c9d-1fa8-4d37-8fa3-348bf0c68bcc_66c43e74-2511-4cdb-a099-fc176673ce02.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,110 mg/kg bw/day,,rat Tetrabutylurea,4559-86-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/619b0ea8-9356-4d6a-9836-92e3912e900a/documents/IUC5-83fe4c9d-1fa8-4d37-8fa3-348bf0c68bcc_66c43e74-2511-4cdb-a099-fc176673ce02.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat Tetrabutylurea,4559-86-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/619b0ea8-9356-4d6a-9836-92e3912e900a/documents/IUC5-83fe4c9d-1fa8-4d37-8fa3-348bf0c68bcc_66c43e74-2511-4cdb-a099-fc176673ce02.html,Repeated dose toxicity – local effects,dermal,NOAEL,27 mg/cm2,adverse effect observed,rat Tetrabutylurea,4559-86-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/619b0ea8-9356-4d6a-9836-92e3912e900a/documents/IUC5-a4ca075f-ec16-4ce1-b139-b244981e27f3_66c43e74-2511-4cdb-a099-fc176673ce02.html,,oral,LD50,"16,742 mg/kg bw",adverse effect observed, Tetrabutylurea,4559-86-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/619b0ea8-9356-4d6a-9836-92e3912e900a/documents/IUC5-a4ca075f-ec16-4ce1-b139-b244981e27f3_66c43e74-2511-4cdb-a099-fc176673ce02.html,,dermal,LD50,"7,500 mg/kg bw",, "Tetrachloro-1,2-difluoroethane",76-12-0,"A reliable secondary source is reported as reference, which discusses the available literature data.The results of several repeted dose toxicity studies are reported.Basing on the exisiting data, 1,1,2,2-tetrachloro-1,2-difluoroethane does not meet the classification criteria for hazard classes related to repeated dose exposure according to Regulation (EC) No. 1272/2008. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9abe8d89-5abf-40ff-913f-17d94aea76aa/documents/IUC5-8edf13f1-f911-4f89-a3e0-a92887e94f68_6b14035b-4f44-4fae-9305-8c58e2776ebe.html,,,,,, "Tetrachloro-1,2-difluoroethane",76-12-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9abe8d89-5abf-40ff-913f-17d94aea76aa/documents/IUC5-8edf13f1-f911-4f89-a3e0-a92887e94f68_6b14035b-4f44-4fae-9305-8c58e2776ebe.html,Short-term repeated dose toxicity – systemic effects,oral,,125 mg/kg bw/day,,rat "Tetrachloro-1,2-difluoroethane",76-12-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/9abe8d89-5abf-40ff-913f-17d94aea76aa/documents/IUC5-8edf13f1-f911-4f89-a3e0-a92887e94f68_6b14035b-4f44-4fae-9305-8c58e2776ebe.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,"4,167.69 mg/m3",,guinea pig "Tetrachloro-1,2-difluoroethane",76-12-0,"A reliable secondary source is reported as reference, which discusses the available literature data.Basing on existing data, no acute toxicity by oral route, dermal route and inhalation is expected for 1,1,2,2 -tetrachloro-1,2 -difluoroethane. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9abe8d89-5abf-40ff-913f-17d94aea76aa/documents/IUC5-d1c8d4fc-02ab-4a1a-8546-15971d4a3e6d_6b14035b-4f44-4fae-9305-8c58e2776ebe.html,,,,,, "Tetrachloro-1,2-difluoroethane",76-12-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9abe8d89-5abf-40ff-913f-17d94aea76aa/documents/IUC5-d1c8d4fc-02ab-4a1a-8546-15971d4a3e6d_6b14035b-4f44-4fae-9305-8c58e2776ebe.html,,oral,discriminating dose,"25,000 mg/kg bw",no adverse effect observed, "Tetrachloro-1,2-difluoroethane",76-12-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9abe8d89-5abf-40ff-913f-17d94aea76aa/documents/IUC5-d1c8d4fc-02ab-4a1a-8546-15971d4a3e6d_6b14035b-4f44-4fae-9305-8c58e2776ebe.html,,dermal,discriminating dose,"7,500 mg/kg bw",no adverse effect observed, "Tetrachloro-1,2-difluoroethane",76-12-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9abe8d89-5abf-40ff-913f-17d94aea76aa/documents/IUC5-d1c8d4fc-02ab-4a1a-8546-15971d4a3e6d_6b14035b-4f44-4fae-9305-8c58e2776ebe.html,,inhalation,discriminating conc.,"125,049 mg/m3",adverse effect observed, Tetrachloro-p-benzoquinone,118-75-2,"- oral:LD50 rat: 6951 mg/kg bw, reliability 2, LD50 cat: >500 mg/kg bw, reliability 2- inhalation:LC50 rat: 2.5 mg/L, reliability 4- dermal: >2000 mg/kg bw, reliability 4 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75182122-5ede-4b98-b696-87e628fc8868/documents/IUC5-bf5ecbd0-77d8-4a14-9e80-61379188c958_cbd5182a-0c47-4ae9-8461-c03e1d7a8f65.html,,,,,, Tetrachloro-p-benzoquinone,118-75-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75182122-5ede-4b98-b696-87e628fc8868/documents/IUC5-bf5ecbd0-77d8-4a14-9e80-61379188c958_cbd5182a-0c47-4ae9-8461-c03e1d7a8f65.html,,oral,LD50,"6,951 mg/kg bw",, Tetrachloro-μ-hydroxy(μ-methacrylato-O:O')dichromium,15096-41-0, The NOAEL for general toxicity was determined to be 200 mg/kg bw/d (reference 7.5.1 -1). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd317940-5015-4c4d-9224-8cd4c537d7b9/documents/26d1ac62-19fb-43aa-8f7a-40d909320f0a_d77edac0-0f12-491f-b1fa-f5c71769b9de.html,,,,,, Tetrachloro-μ-hydroxy(μ-methacrylato-O:O')dichromium,15096-41-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd317940-5015-4c4d-9224-8cd4c537d7b9/documents/26d1ac62-19fb-43aa-8f7a-40d909320f0a_d77edac0-0f12-491f-b1fa-f5c71769b9de.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Tetrachloro-μ-hydroxy(μ-methacrylato-O:O')dichromium,15096-41-0, In an acute oral toxicicty study an oral LD50 of > 2000 mg/kg bw was determined (UN GHS: no classification) (reference 7.2.1-1). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd317940-5015-4c4d-9224-8cd4c537d7b9/documents/df94a5e1-ecb6-436c-aae7-554c84ef3701_d77edac0-0f12-491f-b1fa-f5c71769b9de.html,,,,,, Tetrachloro-μ-hydroxy(μ-methacrylato-O:O')dichromium,15096-41-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd317940-5015-4c4d-9224-8cd4c537d7b9/documents/df94a5e1-ecb6-436c-aae7-554c84ef3701_d77edac0-0f12-491f-b1fa-f5c71769b9de.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Tetracopper hexahydroxide sulphate,1333-22-8," Acute toxicity: Oral A study was performed to assess the acute oral toxicity of the test material according to OECD 423. Animals treated with 2000 mg/kg were found dead during the day of dosing or one day after dosing. No deaths were noted in animals treated with 200 mg/kg. Signs of systemic toxicity noted in females were hunched posture, pilo-erection and diarrhoea. The acute median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl:CD® (SD) IGS BR) strain rat was estimated to be in the range of 300 - 500 mg/kg bodyweight.   Acute toxicity: Dermal A study was performed to assess the acute dermal toxicity of the test material according to OECD 423. There were no deaths on the study and no clinical observations or signs dermal irritation. The acute dermal median lethal dose (LD50) of the test material in the Sprague-Dawley CD (Crl: CD® (SD) IGS BR) strain rat was found to be greater than 2000 mg/kg bodyweight.   Acute toxicity: Inhalation Three groups of rats, consisting of five male and five female rats per group were used for the main study. Rats from groups I, II, and III were exposed to breathing zone concentration levels 3.038, 2.069 and 1.194 mg test item/L of air, respectively. Rats from all groups were exposed for 4 h and surviving rats were observed for a period of 14 days. Sign of toxicity lethargy was observed in rats exposed with the test item. Percent mortalities observed (both sexes combined) were 90, 30, and 10 at the breathing zone concentration levels 3.038, 2.069, and 1.194 mg/L air of test item, respectively which indicates dose dependent mortality. Group I: A decrease in the body weight, was observed in surviving male rat on days 1 and 3 which increased on days 7 and 14 when compared with day 0 body weight. Group II:A decrease in the mean body weight, was observed in surviving rats on days 1, 3 and 7 which increased on day 14 when compared with day 0 mean body weight in both the sexes. Group III: A decrease in the mean body weight, was observed on days 1 and 3 which increased on days 7 and 14 when compared with day 0 body weight in male rats. While, in case of female rats a decrease in the mean body weight, was observed on days 1, 3 and 7 which increased on day 14 when compared with day 0 mean body weight. External examination of the found dead and terminally sacrificed rats did not reveal any abnormality of pathological significance. Visceral examination of the found dead rats revealed liver: reddish discolouration (Rat N º 1, 3, 4 and 9) and lungs: multiple whitish foci (Rat N º 13, 17, 19 and 24) whereas other found dead and terminally sacrificed rats did not reveal any lesion of pathological significance. Lesions observed in the found dead rats could be correlated with the test item used in the present study. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e33cd3e-9606-44bf-8d39-567659106558/documents/6428f333-b10f-4e20-9ae1-9c4afb359fdb_dec2f940-a3f6-4ae0-9049-3df4bce3cf69.html,,,,,, Tetracopper hexahydroxide sulphate,1333-22-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e33cd3e-9606-44bf-8d39-567659106558/documents/6428f333-b10f-4e20-9ae1-9c4afb359fdb_dec2f940-a3f6-4ae0-9049-3df4bce3cf69.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Tetracopper hexahydroxide sulphate,1333-22-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e33cd3e-9606-44bf-8d39-567659106558/documents/6428f333-b10f-4e20-9ae1-9c4afb359fdb_dec2f940-a3f6-4ae0-9049-3df4bce3cf69.html,,inhalation,LC50,"2,091 mg/m3",adverse effect observed, Tetracosanol,506-51-4," In the key study, no adverse effects were seen after dietary administration of a reliable 13 week oral feeding study in rats using hexadecan-1-ol, resulting in a NOAEL value of >4400 mg/kg bw. (Scientific Assoc, 1966a; rel. 2) In addition read across from a reliable 28 day oral gavage study in rats using hexadecan-1-ol reported a NOAEL value of >1000 mg/kg bw (Henkel, 1985a; rel. 2). A four week reliable oral study in rats using octadecan-1-ol reported a NOAEL value of 1000 mg/kg bw, the highest dose tested (Henkel, 1986a; rel. 1). A reliable 26 week oral gavage study in rats using docosan-1-ol reported no adverse effects at the highest dose tested, 1000 mg/kg bw (Iglesias et al., 2002a). Further supporting data come from a 90 day feeding study in rats with of Alcohols, C14-15-branched and linear (Ito et al., 1978) which reported a NOAEL value of >3548 mg/kg bw/day. Read across data from a reliable 13 week dietary study in rats using hexan-1-ol reported a NOAEL of 1127 mg/kg (Scientific Associates Inc., 1966). No adverse effects were noted at any of the dose levels administered during the study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/118da69a-f1cb-4f0c-bd79-7660fedd5ac6/documents/de0e9ef4-d4ce-4eb6-bd4c-01e83884a9f0_4d291f23-2b2d-434b-8c28-6a376359165b.html,,,,,, Tetracosanol,506-51-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/118da69a-f1cb-4f0c-bd79-7660fedd5ac6/documents/de0e9ef4-d4ce-4eb6-bd4c-01e83884a9f0_4d291f23-2b2d-434b-8c28-6a376359165b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"4,400 mg/kg bw/day",,rat Tetracosanol,506-51-4," The key study for acute oral toxicity was read across from docosan-1-ol (CAS 661-19-8), which reports an LD50 value of >2000mg/kg in rat (Safepharm Laboratory, 1997; rel 1). The key study for acute dermal toxicity was read across from icosan-1-ol (CAS 629-96-9), with an LD50 value of 16800 mg/kg (Smyth 1969; rel 2). No testing was required via inhalatory route since high reliability studies are in place via the oral and dermal route. Furthermore, the LC50 is expected to be greater than substantially saturated vapour concentration based on weight of evidence across category. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/118da69a-f1cb-4f0c-bd79-7660fedd5ac6/documents/ea7f1605-2b1c-4566-b22d-d5ed3b96509f_4d291f23-2b2d-434b-8c28-6a376359165b.html,,,,,, Tetracosanol,506-51-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/118da69a-f1cb-4f0c-bd79-7660fedd5ac6/documents/ea7f1605-2b1c-4566-b22d-d5ed3b96509f_4d291f23-2b2d-434b-8c28-6a376359165b.html,,oral,LD50,"2,000 mg/kg bw",, Tetracosanol,506-51-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/118da69a-f1cb-4f0c-bd79-7660fedd5ac6/documents/ea7f1605-2b1c-4566-b22d-d5ed3b96509f_4d291f23-2b2d-434b-8c28-6a376359165b.html,,dermal,LD50,"16,800 mg/kg bw",, "Tetradecaaluminium tetrastrontium pentacosaoxide, dysprosium and europium doped",264145-26-8,Acute oral toxicity > 2000 mg / kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b82e411c-d605-4922-b67a-fadafbcc1ac7/documents/IUC5-2b7e486c-1d22-4fe5-b22b-f7eaedb41e3c_df72f81a-6013-4a56-ba43-31ea9daf332f.html,,,,,, "Tetradecaaluminium tetrastrontium pentacosaoxide, dysprosium and europium doped",264145-26-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b82e411c-d605-4922-b67a-fadafbcc1ac7/documents/IUC5-2b7e486c-1d22-4fe5-b22b-f7eaedb41e3c_df72f81a-6013-4a56-ba43-31ea9daf332f.html,,oral,discriminating dose,"2,000 mg/kg bw",, Tetradecamethylhexasiloxane,107-52-8," There are no repeated dose toxicity data on tetradecamethylhexasiloxane (L6), so good quality data for the related substances, dodecamethylpentasiloxane (L5, 161-53-9) and decamethyltetrasiloxane (L4, 141-62-8), have been used to assess the repeated dose toxicity of tetradecamethylhexasiloxane. In the key 28-day repeated dose oral toxicity study, conducted according to OECD Test Guideline 407 and in compliance with GLP (Dow Corning Corporation, 2010), no biologically significant, treatment-related effects were reported in rats given dodecamethylpentasiloxane (L5) by oral gavage at 25, 250 or 1000 mg/kg bw/day. A NOAEL for systemic toxicity of ≥1000 mg/kg bw/day was concluded.   Following a compliance check draft decision (CCH-D-2114546156-49-01/D) for dodecamethylpentasiloxane (L5), dated 15th March 2021, the registrants intend to perform a 90-day repeated dose toxicity study with dodecamethylpentasiloxane (L5) via the oral route after receipt of the final decision from ECHA. As an interim approach, the subchronic toxicity endpoint for tetradecamethylhexasiloxane (L6) is fulfilled by use of read-across of an existing 90-day inhalation study with the analogue substance, decamethyltetrasiloxane (L4; CAS 141-62-8). However, this read-across will be replaced by the 90-day repeated dose toxicity study with dodecamethylpentasiloxane (L5) via the oral route when the study is available. In a 90-day repeated dose inhalation toxicity study, conducted according to OECD Test Guideline 413 and in compliance with GLP (Dow Corning Corporation, 2010) inhalation of decamethyltetrasiloxane (L4) at concentrations of 70 and 400 ppm were well-tolerated and the concluded NOAEL for systemic toxicity in male and female rats was at least 400 ppm (equivalent to 5083 mg/m³). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7adfef64-e9dc-436b-a4d7-bc4cdb106833/documents/575b3567-43fe-4104-a337-587a4d2ab982_11c6c05e-d9db-40a3-81a6-b4bbad669337.html,,,,,, Tetradecamethylhexasiloxane,107-52-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7adfef64-e9dc-436b-a4d7-bc4cdb106833/documents/575b3567-43fe-4104-a337-587a4d2ab982_11c6c05e-d9db-40a3-81a6-b4bbad669337.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tetradecamethylhexasiloxane,107-52-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7adfef64-e9dc-436b-a4d7-bc4cdb106833/documents/575b3567-43fe-4104-a337-587a4d2ab982_11c6c05e-d9db-40a3-81a6-b4bbad669337.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"5,083 mg/m3",,rat Tetradecamethylhexasiloxane,107-52-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7adfef64-e9dc-436b-a4d7-bc4cdb106833/documents/575b3567-43fe-4104-a337-587a4d2ab982_11c6c05e-d9db-40a3-81a6-b4bbad669337.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"5,083 mg/m3",no adverse effect observed,rat Tetradecamethylhexasiloxane,107-52-8," The key study for acute oral toxicity is read across from the structurally analogous substance octamethyltrisiloxane (CAS 107-51-8). Based on the available information an LD50 value of >2000 mg/kg was determined. The study was conducted according to an appropriate OECD test protocol, and in compliance with GLP (Dow Corning Corporation, 2004a). The key study for acute dermal toxicity is read across from the structurally analogous substance dodecamethylpentasiloxane (CAS 141-63-6). Based on the available information an LD50 value of >2000 mg/kg was determined. The study was conducted according to an appropriate OECD test protocol, and in compliance with GLP (Dow Corning Corporation, 2009). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7adfef64-e9dc-436b-a4d7-bc4cdb106833/documents/ad338c92-fec3-4535-a4c2-edb9d487f989_11c6c05e-d9db-40a3-81a6-b4bbad669337.html,,,,,, Tetradecamethylhexasiloxane,107-52-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7adfef64-e9dc-436b-a4d7-bc4cdb106833/documents/ad338c92-fec3-4535-a4c2-edb9d487f989_11c6c05e-d9db-40a3-81a6-b4bbad669337.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetradecamethylhexasiloxane,107-52-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7adfef64-e9dc-436b-a4d7-bc4cdb106833/documents/ad338c92-fec3-4535-a4c2-edb9d487f989_11c6c05e-d9db-40a3-81a6-b4bbad669337.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetradecanedioic acid,821-38-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64a90bbf-672a-46da-9f33-c821def209bd/documents/IUC5-9b693f6c-631b-4589-864e-e15151874569_ccf7cfe0-d559-49d7-91ea-bcd27c8f95b2.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tetradecanedioic acid,821-38-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64a90bbf-672a-46da-9f33-c821def209bd/documents/IUC5-ebd666bd-9da9-4e96-ba45-2b330c73ec64_ccf7cfe0-d559-49d7-91ea-bcd27c8f95b2.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Tetradecanedioic acid,821-38-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64a90bbf-672a-46da-9f33-c821def209bd/documents/IUC5-ebd666bd-9da9-4e96-ba45-2b330c73ec64_ccf7cfe0-d559-49d7-91ea-bcd27c8f95b2.html,,dermal,LD50,"6,000 mg/kg bw",no adverse effect observed, Tetradecyl acrylate,21643-42-5," In a well-conducted OECD TG 422 combined repeated dose and reproductive/developmental toxicity screening test with the structural analogue 2-Propenoic acid, C12-14-alkyl esters (mixture of CAS no. 2156-97-0 and 21643-42-5) by oral gavage in rats no toxicity occurred up to the highest administered dose of 1000 mg/kg bw/day. The NOAEL was determined to 1000 mg/kg bw/day. Based on these results the NOAEL value of 2 -Propenoic acid, tetradecyl ester is also considered to be 1000 mg/kg bw/day. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c3f7188-228d-40a4-8882-a5bcdb251317/documents/7be628be-e847-417c-a70b-cc644273f778_a290bfd5-1bc3-4f16-b3bd-daef6f0df5ff.html,,,,,, Tetradecyl acrylate,21643-42-5,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/6c3f7188-228d-40a4-8882-a5bcdb251317/documents/7be628be-e847-417c-a70b-cc644273f778_a290bfd5-1bc3-4f16-b3bd-daef6f0df5ff.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tetradecyl acrylate,21643-42-5," Several read across substances were tested in two oral studies, in two acute inhalation studies and in one dermal study. The read across substances revealed an oral LD50 > 5570 mg/kg bw. The read across substances revealed an inhalation LC50 (8h) > 0.69 mg/L air. The LD50 (dermal, rat) was > 5000 mg/kg bw. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c3f7188-228d-40a4-8882-a5bcdb251317/documents/74164b23-4a5b-4449-8624-fedd75a38925_a290bfd5-1bc3-4f16-b3bd-daef6f0df5ff.html,,,,,, Tetradecyl acrylate,21643-42-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c3f7188-228d-40a4-8882-a5bcdb251317/documents/74164b23-4a5b-4449-8624-fedd75a38925_a290bfd5-1bc3-4f16-b3bd-daef6f0df5ff.html,,oral,discriminating dose,"5,570 mg/kg bw",no adverse effect observed, Tetradecyl acrylate,21643-42-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c3f7188-228d-40a4-8882-a5bcdb251317/documents/74164b23-4a5b-4449-8624-fedd75a38925_a290bfd5-1bc3-4f16-b3bd-daef6f0df5ff.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Tetradecyl acrylate,21643-42-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6c3f7188-228d-40a4-8882-a5bcdb251317/documents/74164b23-4a5b-4449-8624-fedd75a38925_a290bfd5-1bc3-4f16-b3bd-daef6f0df5ff.html,,inhalation,discriminating conc.,690 mg/m3,no adverse effect observed, Tetradecyl chloroformate,56677-60-2,oral: The oral LD50 of Tetradecyl chlorformate was determined to be greater than 5000 mg/kg bw in rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0006b9ea-8bd8-4235-86db-6cd5ad287cda/documents/IUC5-681faca4-9a3e-40e8-8d63-67184fcdca95_32be8f22-f280-46d4-be7a-2b29428701db.html,,,,,, Tetradecyl methacrylate,2549-53-3,"Subacute study; oral (gavage); rat (Sprague Dawley SD), m/f (OECD guideline 422, Klimisch score: 1,GLP), no toxicity occurred up to the highest administered dose of 1000 mg/kg/day with the structural analogue dodecyl methacrylate: NOAEL = 1000 mg/kg bw/d (CIT, 2007).With regard to the low repeated dose oral toxicity and the characteristics of skin penetration and metabolism in the skin, the repeated dose dermal toxicity can be considered as low. The inhalation route is not of relevance due to the very low vapour pressure of the substance. There is no study available for tetradecyl methacrylate but for structural analogue substances dodecyl methacrylate and 2-ethylhexyl methacrylate. In a well-conducted OECD combined repeated dose and reproductive/developmental toxicity screening test (OECD TG 422) by oral gavage in rats no toxicity occurred up to the highest administered dose of 1000 mg/kg/day. The NOAEL was determined to 1000 mg/kg/day. (CIT, 2007, relaible without restriction (Klimisch score: 1)) Supporting information: OECD guideline 408 90-day gavage study in Wistar rats with the C8 Ester 2-ethylhexyl methacrylate, including a recovery period of 28 days, signs of general systemic toxicity occurred in male as well as female rats at 360 mg/kg bw/day. NOAEL was 120 mg/kg bw/day in males and females. Relaible witout restriction (BASF, 2009, Klimisch score: 1, GLP) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4776d31-2f4c-48f5-a6e3-3575fd9d0e17/documents/f5b41be8-ee4b-44b4-8c79-9084b9a2e59c_f6d25d30-c5c9-4963-b1c4-01d58506b7eb.html,,,,,, Tetradecyl methacrylate,2549-53-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b4776d31-2f4c-48f5-a6e3-3575fd9d0e17/documents/f5b41be8-ee4b-44b4-8c79-9084b9a2e59c_f6d25d30-c5c9-4963-b1c4-01d58506b7eb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tetradecyl methacrylate,2549-53-3,"Acute oral toxicity: GLP Guideline study, LD50 <2000 mg/kg bw Inhalation is no relevant route of exposure and testing by inhalation is not appropriate. Exposure of humans via inhalation is unlikely taking into account the low vapour pressure and the low possibility of exposure to aerosols, particles or droplets of an inhalable size. Furthermore no reliable data are available on long-chain methacrylate esters (C12 – C22) for the inhalation route. However, data are available on the structural analogues substances: methyl-, ethyl- and n-butyl methacrylate. The respective LC50 values are in a range between 5000 and 11000 ppm indicating low inhalation toxicity. In a dermal acute toxicity study on isodecyl methacrylate (structurally related substance of tetradecyl methacrylate) with albino rabbits an LD50 > 3000 mg/kg was determined. Reliable study according to generally accepted scientific standards and decribed in sufficient detail. This experimentally observed result is supported by a dermal toxicity study with structural analogue dodecyl pentadecyl methacrylate where a LD50: > 5000 mg/kg, dermal, rabbit was observed (Rohm & Haas, 1975). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4776d31-2f4c-48f5-a6e3-3575fd9d0e17/documents/41f30764-6606-4b8e-876b-51d21ca80d95_f6d25d30-c5c9-4963-b1c4-01d58506b7eb.html,,,,,, Tetradecyl methacrylate,2549-53-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4776d31-2f4c-48f5-a6e3-3575fd9d0e17/documents/41f30764-6606-4b8e-876b-51d21ca80d95_f6d25d30-c5c9-4963-b1c4-01d58506b7eb.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetradecyl methacrylate,2549-53-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b4776d31-2f4c-48f5-a6e3-3575fd9d0e17/documents/41f30764-6606-4b8e-876b-51d21ca80d95_f6d25d30-c5c9-4963-b1c4-01d58506b7eb.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, Tetradecyl oleate,22393-85-7,NOAEL systemic= 300 mg/kg bw/day ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c84a6cea-4f78-4537-9107-c1c52a99308c/documents/IUC5-762c062b-aa79-4e8f-8552-26419220906b_bd90cf5b-e3fa-48bc-8ae9-49b5f3e0b3b8.html,,,,,, Tetradecyl oleate,22393-85-7,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/c84a6cea-4f78-4537-9107-c1c52a99308c/documents/IUC5-762c062b-aa79-4e8f-8552-26419220906b_bd90cf5b-e3fa-48bc-8ae9-49b5f3e0b3b8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Tetradecyl oleate,22393-85-7,All available acute oral toxicity studies within this category resulted in an acute oral LD50 > 2000 mg/kg bw. All available acute dermal toxicity studies within the category resulted in acute dermal LD50 > 2000 mg/kg bw. All available acute inhalation toxicity studies within the category resulted in acute inhalation LC50 > 5.0 mg/L air. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c84a6cea-4f78-4537-9107-c1c52a99308c/documents/IUC5-e1a1198c-9e4b-42fe-b4a1-8b4e8f9766f0_bd90cf5b-e3fa-48bc-8ae9-49b5f3e0b3b8.html,,,,,, Tetradecyloxirane,7320-37-8,The NOAEL for oral repeated dose toxicity was determined to be 750 mg/kg bw/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aeca513f-e2cc-4d61-bb79-5365081faf81/documents/IUC5-4e617f3c-3fa1-43bb-813b-612af18962a5_07d38f6d-b687-4465-9ee5-165cd7386fe7.html,,,,,, Tetradecyloxirane,7320-37-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aeca513f-e2cc-4d61-bb79-5365081faf81/documents/IUC5-4e617f3c-3fa1-43bb-813b-612af18962a5_07d38f6d-b687-4465-9ee5-165cd7386fe7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat Tetradecyloxirane,7320-37-8,The oral LD50 was determined to be >5000 mg/kg bw.The dermal LD50 was determined to be >2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aeca513f-e2cc-4d61-bb79-5365081faf81/documents/IUC5-3ea0226a-aac1-4612-96cc-de6eb2ac2309_07d38f6d-b687-4465-9ee5-165cd7386fe7.html,,,,,, Tetradecyloxirane,7320-37-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aeca513f-e2cc-4d61-bb79-5365081faf81/documents/IUC5-3ea0226a-aac1-4612-96cc-de6eb2ac2309_07d38f6d-b687-4465-9ee5-165cd7386fe7.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Tetradecyloxirane,7320-37-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aeca513f-e2cc-4d61-bb79-5365081faf81/documents/IUC5-3ea0226a-aac1-4612-96cc-de6eb2ac2309_07d38f6d-b687-4465-9ee5-165cd7386fe7.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Fatty acids, heptanoic, nonanoic and 2-ethylhexanoic, tetraesters with pentaerythritol",1547205-02-6,"Oral: OECD 408, rat, NOAEL ≥ 1000 mg/kg bw/dayInhalation: OECD 408, rat, NOAEC 0.56 mg/L (nominal concentration)Dermal: OECD 408, rat, NOAEL ≥ 2000 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c929917a-7b25-4d91-8545-aaba261e135f/documents/IUC5-7e3f36f4-f43c-4c8a-bc37-5edbaa2ea62b_29fbe2ba-1d7d-4ac7-8e0b-f983c9e788c9.html,,,,,, "Fatty acids, heptanoic, nonanoic and 2-ethylhexanoic, tetraesters with pentaerythritol",1547205-02-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c929917a-7b25-4d91-8545-aaba261e135f/documents/IUC5-7e3f36f4-f43c-4c8a-bc37-5edbaa2ea62b_29fbe2ba-1d7d-4ac7-8e0b-f983c9e788c9.html,Repeated dose toxicity – local effects,dermal,LOAEL,800 ,adverse effect observed,rat "Fatty acids, heptanoic, nonanoic and 2-ethylhexanoic, tetraesters with pentaerythritol",1547205-02-6,Oral (WoE): LD50 > 2000 mg/kg bw Inhalation (WoE): LC50 > 5.1 mg/LDermal (WoE): LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c929917a-7b25-4d91-8545-aaba261e135f/documents/IUC5-f1812b05-824a-47b0-a677-a044e2f3e2b9_29fbe2ba-1d7d-4ac7-8e0b-f983c9e788c9.html,,,,,, "Tetraethyl 2,2'-(1,4-phenylenedimethylidyne)bismalonate",6337-43-5,"Oral:Relevant NOAEL (equivalent to OECD 407, gavage, rat): 1000 mg/kg bw/dA 28 -day repeated oral dose toxicity study of the test item followed by a 14 -day recovery study was performed in groups of five male and five female Crl:CD (SD) rats at 5 weeks of age. The high dose was set at 1000 mg/kg/day, and altogether 3 doses including 150 and 25 mg/kg/day were employed. Recovery groups were also set for the 1000 mg/kg and vehicle control groups.No death occurred and no abnormalities were noted in all examinations.No abnormalities were noted in the recovery test.Based on these results, the NOEL and NOAEL of the test item in rats under the present study conditions were estimated to be 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1dbb813-6e57-4097-ae4a-abeea5c2ea31/documents/IUC5-9f6632f9-97e8-4f9d-ab2b-c3ed93b32d52_6ef49f4d-cc32-45f9-bdc8-91874115dcda.html,,,,,, "Tetraethyl 2,2'-(1,4-phenylenedimethylidyne)bismalonate",6337-43-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a1dbb813-6e57-4097-ae4a-abeea5c2ea31/documents/IUC5-9f6632f9-97e8-4f9d-ab2b-c3ed93b32d52_6ef49f4d-cc32-45f9-bdc8-91874115dcda.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Tetraethyl 2,2'-(1,4-phenylenedimethylidyne)bismalonate",6337-43-5,"Acute toxicity after single oral application was tested in male and female rats, which received 2,000 mg/kg bw. No animal died or showed clinical symptoms/macroscopic anomalies. The necropsy did not reveal any effect. The LD50 value for acute oral toxicity was considered to be greater than 2,000 mg/kg bw. Due to the findings described above (LD50 oral in rats greater than 2,000 mg/kg bw) the test item does not have to be classified as acute orally toxic.Five male and five female rats were treated with the test substance at 2,000 mg/kg by dermal application. The test item was diluted in vehicle (PEG 300) at a concentration of 0.5 g/mL and administered at a volume dosage of 4 mL/kg. The application period was 24 hours. No deaths occurred. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were observed at necropsy. The median lethal dose of the test substance after single dermal administration to rats of both sexes, observed over a period of 14 days is LD50 (rat): greater than 2,000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1dbb813-6e57-4097-ae4a-abeea5c2ea31/documents/IUC5-743f3629-120c-4e90-bb0c-a12e2a9461e6_6ef49f4d-cc32-45f9-bdc8-91874115dcda.html,,,,,, "Tetraethyl 2,2'-(1,4-phenylenedimethylidyne)bismalonate",6337-43-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1dbb813-6e57-4097-ae4a-abeea5c2ea31/documents/IUC5-743f3629-120c-4e90-bb0c-a12e2a9461e6_6ef49f4d-cc32-45f9-bdc8-91874115dcda.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetraethyl 2,2'-(1,4-phenylenedimethylidyne)bismalonate",6337-43-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a1dbb813-6e57-4097-ae4a-abeea5c2ea31/documents/IUC5-743f3629-120c-4e90-bb0c-a12e2a9461e6_6ef49f4d-cc32-45f9-bdc8-91874115dcda.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "tetraethyl N,N'-(methylenedicyclohexane-4,1-diyl)bis-DL-aspartate",136210-30-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): A short term oral toxicity study (28-days; Bomhard, Bayer AG, 1992b) with the read across substance revealed no toxicological effects. The derived NOAEL was 1000 mg/kg bw/day. In a two-generation reproductive toxicity study mild kidney effects (basophilic tubules and focal tubular dilation/hyaline casts) were seen in males only at a dose of 1000 mg/kg bw/day. The basophilic tubules and focal tubular dilation/hyaline casts are common spontaneous findings in male rats of this age but as a worst case assumption these findings were concluded to be adverse, since they correlated with statistically significantly elevated absolute and/or relative kidney weights, evident for F0 and F1 rats at 1000 mg/kg. Thus, 1000 mg/kg turned out to be a LOAEL and 200 mg/kg a NOAEL in the study based on such kidney responses. It is not expected that a 90-days repeated dose toxicity study according to OECD TG 408 would substantially change the assessment of the substance, therefore the available information on repeated dose toxicity meets the tonnage driven data requirement of REACH. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7eb68e8-6039-4c5f-8ab9-363fc6035f30/documents/IUC5-c786a954-5724-4645-b7ea-de55a067578c_dd690d7d-ee5b-4aa9-a68f-079de0419e84.html,,,,,, "tetraethyl N,N'-(methylenedicyclohexane-4,1-diyl)bis-DL-aspartate",136210-30-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7eb68e8-6039-4c5f-8ab9-363fc6035f30/documents/IUC5-c786a954-5724-4645-b7ea-de55a067578c_dd690d7d-ee5b-4aa9-a68f-079de0419e84.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,"1,000 mg/kg bw/day",,rat "tetraethyl N,N'-(methylenedicyclohexane-4,1-diyl)bis-DL-aspartate",136210-30-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7eb68e8-6039-4c5f-8ab9-363fc6035f30/documents/IUC5-ef658686-5e00-4f24-8d0e-c0d473a81841_dd690d7d-ee5b-4aa9-a68f-079de0419e84.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "tetraethyl N,N'-(methylenedicyclohexane-4,1-diyl)bis-DL-aspartate",136210-30-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7eb68e8-6039-4c5f-8ab9-363fc6035f30/documents/IUC5-ef658686-5e00-4f24-8d0e-c0d473a81841_dd690d7d-ee5b-4aa9-a68f-079de0419e84.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "tetraethyl N,N'-(methylenedicyclohexane-4,1-diyl)bis-DL-aspartate",136210-30-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7eb68e8-6039-4c5f-8ab9-363fc6035f30/documents/IUC5-ef658686-5e00-4f24-8d0e-c0d473a81841_dd690d7d-ee5b-4aa9-a68f-079de0419e84.html,,inhalation,discriminating conc.,"4,224 mg/m3",no adverse effect observed, Tetraethyl orthocarbonate,78-09-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c0c70eb-9b4b-4ec5-889d-0a3de8fea62d/documents/0c99acf8-45b4-472f-a6f4-1d2590b2ae81_aa49de5d-034f-4d3b-a042-eea1b075cf46.html,,oral,LD50,"7,060 mg/kg bw",no adverse effect observed, Tetraethyl orthocarbonate,78-09-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c0c70eb-9b4b-4ec5-889d-0a3de8fea62d/documents/0c99acf8-45b4-472f-a6f4-1d2590b2ae81_aa49de5d-034f-4d3b-a042-eea1b075cf46.html,,dermal,LD50,"180,000 mg/kg bw",no adverse effect observed, Tetraethyl orthocarbonate,78-09-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5c0c70eb-9b4b-4ec5-889d-0a3de8fea62d/documents/0c99acf8-45b4-472f-a6f4-1d2590b2ae81_aa49de5d-034f-4d3b-a042-eea1b075cf46.html,,inhalation,LC50,26.1 mg/m3,no adverse effect observed, Tetraethylammonium benzoate,16909-22-1," The test substance harmful if swallowed with an oral LD50 (rat) between 300 and 2000 mg/kg b.w. (LPT, 2016). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c9e9e31f-a78b-408a-a943-5a0db6fc2312/documents/3f7d7a87-7813-4f20-bfb6-318b99b265d9_c2d3e6d8-8cba-45a8-9159-a6637437882a.html,,,,,, Tetraethylammonium chloride,56-34-8," Acute oral toxicity LD50 was estimated to be 2630 mg/kg bw when rats were orally exposed with N, N, N-triethylethanaminium chloride (56-34-8) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29a66535-49e3-4fc9-b3cd-83cd47ca8a67/documents/eac860bb-d68c-467f-ab2a-59b059f30517_d4bd1720-3a3e-40cc-a9cc-365c3d4c5f01.html,,,,,, Tetraethylammonium chloride,56-34-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29a66535-49e3-4fc9-b3cd-83cd47ca8a67/documents/eac860bb-d68c-467f-ab2a-59b059f30517_d4bd1720-3a3e-40cc-a9cc-365c3d4c5f01.html,,oral,LD50,"2,630 mg/kg bw",adverse effect observed, Tetraethylammonium heptadecafluorooctanesulphonate,56773-42-3,"A 90 day oral feed study of PFOS in rats and several not assignable (secondary literature) subacute and subchronic gavage or capsule sudies in monkeys were conducted. Additional a 104-week dietary chronic toxicity and carcinogenicity study with perfluorooctane sulfonic acid potassium salt (PFOS) in rats is as secondary literature available. Based on the liver toxicity, the no-observed-adverse-effect level (NOAEL) for PFOS is considered to be 0.5 ppm (0.5  ppm corresponds with 0.017-0.057 mg/kg body weight/day ) in male rats and 2 ppm (2.0 ppm corresponds with 0.095-0.213 mg/kg bw/day) in female rats. In the rat subchronic study CD rats, 5/sex/group, were administered dietary levels of 0, 30, 100, 300, 1000 or 3000 ppm PFOS (FC-95) for 90 days. The dietary levels were equivalent to doses of 0, 2, 6, 18, 60 and 200 mg/kg/day. A NOAEL was not identified in this study.In the first ninety-day subacute rhesus monkey toxicity study doses of 0, 10, 30, 100 or 300 mg/kg/day PFOS were applied by gavage. all animals died. In the second ninety-day subacute rhesus monkey toxicity study doses of 0, 0.5, 1.5 or 4.5 mg/kg/day PFOS (FC-95) in distilled water by gavagewere administerd. A NOAEL was not found, the LOAEL 0.5 mg/kg/day. Additional, PFOS (potassium perfluoroctane sulfonate) was administered to cynomolgus monkeys by oral capsule at doses of 0 (6 monkeys per sex), 0.03 (4 monkeys per sex), 0.15 (6 monkeys per sex), or 0.75 mg/kg/day (6 monkeys per sex) for 26 weeks. The NOAEL = 0.15 mg/kg bw/d. PFOS is toxic to cynamolgous monkeys at 0.75 mg/kg/day causing death, alterations in total cholesterol, and effecting liver weight and causing hepatocellular hypertrophy and vacuolation in both treated males and females. In the 28 day capsule dose range finding study no NOAEL was determined.As secondary literature a 104-Week Dietary Chronic Toxicity and Carcinogenicity Study with Perfluorooctane Sulfonic Acid Potassium Salt (PFOS) in rats is available. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/197f61ca-0a2d-43f6-922b-3475566cfba0/documents/IUC5-73174782-7671-4018-8041-74c0fc023f7f_6ec330d7-8091-4d17-8f0a-c527eb3ef6e4.html,,,,,, Tetraethylammonium heptadecafluorooctanesulphonate,56773-42-3,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/197f61ca-0a2d-43f6-922b-3475566cfba0/documents/IUC5-73174782-7671-4018-8041-74c0fc023f7f_6ec330d7-8091-4d17-8f0a-c527eb3ef6e4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.15 mg/kg bw/day,,monkey Tetraethylammonium heptadecafluorooctanesulphonate,56773-42-3,"Several acute toxicity studies were performed with tetraethylammonium heptadecafluorooctanesulphonate .In the key study for acute oral toxicity a LD50 = 190 mg/kg bw (rat, male) was found. In another study in rats a LD50 = 632 mg/kg bw (female rats); LD50 > 200 mg/kg bw (male rats) was determined. In a not assignable study (secondary literature) in rats acute oral LD50 values and 95% confidence limits were calculated for male rats (233 [160-339] mg/kg), females (271 [200-369] mg/kg) and combined male and female rats (251 [199-318] mg/kg). Acute inhalative toxicity was tested with the test substance in male rats, mice, hamsters, rabbits. Rats and mic were exposed whole body for 1 hours at room temperature to a concentration of 1368 and 9337 mg/m³; hamster and rabbits were exposed whole body for 1 hours at room temperature to a concentration of 1375 and 9087 mg/m³ of the test substance in an 400 l inhalation chamber. Mortality and clinical signs were recorded during a post-expsoure period of 7 days. Rats and mic were exposed whole body for 4 hours at room temperature to a concentration of 1585, 1575 or 11612 mg/m³; hamster and rabbits were exposed whole body for 4 hours at room temperature to a concentration of 1730 or 10325 mg/m³ of the test substance in an 400 l inhalation chamber. Mortality and clinical signs were recorded during a post-expsoure period of 7 days. In both studies no mortality was observed. In a not assignable study (secondary literature) PFOS dust was administered whole body for 4 h in air to Sprague-Dawley rats, 5/sex/group, levels of 1.89 to 45.97 mg/l PFOS to eight test groups. An LC50 = 5.2 (4.4 – 6.4) mg/l was determined.a valid study for dermal toxicity determined a LD50 > 2000 mg/kg bw. At 2000 mg/kg bw one out of 10 animals died. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/197f61ca-0a2d-43f6-922b-3475566cfba0/documents/IUC5-58e11380-73f8-46d7-9e01-f6a9da5e2b98_6ec330d7-8091-4d17-8f0a-c527eb3ef6e4.html,,,,,, Tetraethylammonium heptadecafluorooctanesulphonate,56773-42-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/197f61ca-0a2d-43f6-922b-3475566cfba0/documents/IUC5-58e11380-73f8-46d7-9e01-f6a9da5e2b98_6ec330d7-8091-4d17-8f0a-c527eb3ef6e4.html,,oral,LD50,200 mg/kg bw,, Tetraethylammonium heptadecafluorooctanesulphonate,56773-42-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/197f61ca-0a2d-43f6-922b-3475566cfba0/documents/IUC5-58e11380-73f8-46d7-9e01-f6a9da5e2b98_6ec330d7-8091-4d17-8f0a-c527eb3ef6e4.html,,dermal,LD50,"2,000 mg/kg bw",, Tetraethylammonium heptadecafluorooctanesulphonate,56773-42-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/197f61ca-0a2d-43f6-922b-3475566cfba0/documents/IUC5-58e11380-73f8-46d7-9e01-f6a9da5e2b98_6ec330d7-8091-4d17-8f0a-c527eb3ef6e4.html,,inhalation,LC50,"1,000 mg/m3",, Tetraethylammonium hydroxide,77-98-5," In a 90-day oral repeated dose toxicity study with rats, conducted according to OECD/EC guidelines and GLP principles, the NOAEL (oral route) was found to be exceed 100 mg/kg bw/day, based on absence of adverse effects at the highest dose level tested. A repeated dose toxicity was conducted with substance analogue TMAH comparable to OECD guideline 410 (1981) and according to GLP. Due to significant effects on the skin a NOAEL for local effects was determined to be 5,5 mg/kg/day for males and 2.5 mg/kg/day for females. The NOAEL for systemic toxicity was found to be 10 mg/kg/day for both sexes. This result is read across to TEAH, the justification is attached in Section 13. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e92ad39a-dd70-467d-9b77-9a441c22e461/documents/IUC5-8f181317-396b-441e-89c1-2b690640f4d7_f3dac862-24e0-4fd8-a14b-9711e0232074.html,,,,,, Tetraethylammonium hydroxide,77-98-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e92ad39a-dd70-467d-9b77-9a441c22e461/documents/IUC5-8f181317-396b-441e-89c1-2b690640f4d7_f3dac862-24e0-4fd8-a14b-9711e0232074.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rat Tetraethylammonium hydroxide,77-98-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e92ad39a-dd70-467d-9b77-9a441c22e461/documents/IUC5-8f181317-396b-441e-89c1-2b690640f4d7_f3dac862-24e0-4fd8-a14b-9711e0232074.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Tetraethylammonium hydroxide,77-98-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e92ad39a-dd70-467d-9b77-9a441c22e461/documents/IUC5-8f181317-396b-441e-89c1-2b690640f4d7_f3dac862-24e0-4fd8-a14b-9711e0232074.html,Repeated dose toxicity – local effects,dermal,NOAEL,18.75 ,adverse effect observed, Tetraethylammonium hydroxide,77-98-5,"Oral toxicity: In an acute oral toxicity study with rats, performed according to OECD/EC test guidelines, an LD50 > 300 mg/ kg bw and <2000 mg/kg bw was determined for TEAH. This corresponds to an LD50 of >0.844 mL/kg bw and < 5.627mL/kg bw for TEAH 35% in water.Dermal toxicity: One reliable study (without restrictions) with TEAH 35% in water is available, which shows that the dermal LD50 > 2000 mg/kg bw. This is equivalent to an LD50 of >700 mg/kg bw for TEAH. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e92ad39a-dd70-467d-9b77-9a441c22e461/documents/IUC5-b114ab6b-6c4b-4ae3-900c-d2703e5c89c3_f3dac862-24e0-4fd8-a14b-9711e0232074.html,,,,,, Tetraethylammonium hydroxide,77-98-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e92ad39a-dd70-467d-9b77-9a441c22e461/documents/IUC5-b114ab6b-6c4b-4ae3-900c-d2703e5c89c3_f3dac862-24e0-4fd8-a14b-9711e0232074.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Tetraethylammonium hydroxide,77-98-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e92ad39a-dd70-467d-9b77-9a441c22e461/documents/IUC5-b114ab6b-6c4b-4ae3-900c-d2703e5c89c3_f3dac862-24e0-4fd8-a14b-9711e0232074.html,,dermal,LD50,700 mg/kg bw,adverse effect observed, Tetraethyllead,78-00-2," The key study and the key value for CSA for Oral toxicity was completed on rats. Several supporting studies at higher doses support the quoted LOAEL for Repeated Dose Oral Toxicity. A waiver has been submitted for repeated dose dermal toxicity testing Two repeat inhalation toxicity conducted by Davis on rats and beagles gave very similar conclusions with LOAEC levels of 12 mg/m3. LD100 values are also reported and differ for the two species, with a value of 22 mg/m3 quoted for rats and 12 mg/m3 for the dogs ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75620d32-ec82-4307-ab72-88f3bdbe2aae/documents/f6d00129-4370-441a-9639-7f1570d126ed_56de06b9-64ef-42ab-aa4a-74a13c1fb145.html,,,,,, Tetraethyllead,78-00-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75620d32-ec82-4307-ab72-88f3bdbe2aae/documents/f6d00129-4370-441a-9639-7f1570d126ed_56de06b9-64ef-42ab-aa4a-74a13c1fb145.html,Sub-chronic toxicity – systemic effects,oral,LOAEL,0.2 mg/kg bw/day,,rat Tetraethyllead,78-00-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/75620d32-ec82-4307-ab72-88f3bdbe2aae/documents/f6d00129-4370-441a-9639-7f1570d126ed_56de06b9-64ef-42ab-aa4a-74a13c1fb145.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,12 mg/m3,,dog Tetraethyllead,78-00-2,"The LD50 values for this material have been repeatedly tested orally, dermally and by inhalation. All study groups show simliar values for each exposure type, therefore there is much supporting evidence to back up the key value studies used to classify the substance as very toxic even though in many cases full details of test methods are not available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75620d32-ec82-4307-ab72-88f3bdbe2aae/documents/83af3cb9-6920-4deb-8f27-d1705ac4b64e_56de06b9-64ef-42ab-aa4a-74a13c1fb145.html,,,,,, Tetraethyllead,78-00-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75620d32-ec82-4307-ab72-88f3bdbe2aae/documents/83af3cb9-6920-4deb-8f27-d1705ac4b64e_56de06b9-64ef-42ab-aa4a-74a13c1fb145.html,,oral,LD50,14.18 mg/kg bw,adverse effect observed, Tetraethyllead,78-00-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75620d32-ec82-4307-ab72-88f3bdbe2aae/documents/83af3cb9-6920-4deb-8f27-d1705ac4b64e_56de06b9-64ef-42ab-aa4a-74a13c1fb145.html,,dermal,discriminating dose,547 mg/kg bw,adverse effect observed, Tetraethyllead,78-00-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75620d32-ec82-4307-ab72-88f3bdbe2aae/documents/83af3cb9-6920-4deb-8f27-d1705ac4b64e_56de06b9-64ef-42ab-aa4a-74a13c1fb145.html,,inhalation,LC50,850 mg/m3,adverse effect observed, Tetrafluoroboric acid,16872-11-0,"A NOAEL of 40 mg/kg bw/day for systemic effects was established in an oral reproduction/developmental toxicity screening test and a NOAEL of 74 mg/m3 for systemic effects was established in a 28-day inhalation study in rats exposed to KBF4, a structural analogue of HBF4. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0bfac62e-e449-4b9a-b650-44565af01439/documents/IUC5-c7252ff3-079c-42ab-9fd1-43c0d3968fa7_b9f5a1c7-2eca-4f8f-923b-ae875d06b598.html,,,,,, Tetrafluoroboric acid,16872-11-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0bfac62e-e449-4b9a-b650-44565af01439/documents/IUC5-c7252ff3-079c-42ab-9fd1-43c0d3968fa7_b9f5a1c7-2eca-4f8f-923b-ae875d06b598.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat Tetrafluoroboric acid,16872-11-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0bfac62e-e449-4b9a-b650-44565af01439/documents/IUC5-c7252ff3-079c-42ab-9fd1-43c0d3968fa7_b9f5a1c7-2eca-4f8f-923b-ae875d06b598.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,74 mg/m3,,rat Tetrafluoroboric acid,16872-11-0,"Acute oral, dermal or inhalation toxicity studies were not performed because the substance is a strong acid (pKa -4.9) and is classified as corrosive to the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0bfac62e-e449-4b9a-b650-44565af01439/documents/IUC5-6faaa122-3c31-4dd5-bd5a-fb167921bdb4_b9f5a1c7-2eca-4f8f-923b-ae875d06b598.html,,,,,, "Tetrahydro-2,5-dimethoxyfuran",696-59-3,"Oral route (rat, gavage, 48 -58 days): No Observed Adverse Effect Level (NOAEL) of 2,5-Dimethoxytetrahydrofuran is 250 mg/kg/day (OECD TG 422) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48e17da7-c0ab-4beb-8f74-567326d27dc5/documents/b80ff401-3865-42fd-ab65-4196463b46e0_1e233d41-9971-49d0-b6a9-0cda7dce66a3.html,,,,,, "Tetrahydro-2,5-dimethoxyfuran",696-59-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/48e17da7-c0ab-4beb-8f74-567326d27dc5/documents/b80ff401-3865-42fd-ab65-4196463b46e0_1e233d41-9971-49d0-b6a9-0cda7dce66a3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Tetrahydro-2,5-dimethoxyfuran",696-59-3,"LD50 dermal, rat > 2000 mg/kg LD0 oral gavage, rat: 900 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48e17da7-c0ab-4beb-8f74-567326d27dc5/documents/1e4e8302-4098-4390-afd0-cae2ab971967_1e233d41-9971-49d0-b6a9-0cda7dce66a3.html,,,,,, "Tetrahydro-2,5-dimethoxyfuran",696-59-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/48e17da7-c0ab-4beb-8f74-567326d27dc5/documents/1e4e8302-4098-4390-afd0-cae2ab971967_1e233d41-9971-49d0-b6a9-0cda7dce66a3.html,,oral,discriminating dose,900 mg/kg bw,adverse effect observed, Tetrahydro-2-methylfuran,96-47-9,"Repeat dose oral: A very limited published report of a three-month oral study in rats, conducted to GLP but with no stated guideline, found no toxicity at the highest tested dose of 26 mg/kg bw/day. In a robust, 90-day oral gavage study in rats, MeTHF was administered once daily at dose levels of 0 (water), 80, 250, 500 and 1000 mg/kg bw/day. A further group of rats (5/sex/group) which received the control and high dose group were retained for a further month free of administration of test article, for a 1 month recovery period. Following 90 d of treatment (or 1 month post dosing) animals were subjected to complete necropsy. Body weight, food consumption were measured at regular intervals. Clinical pathology evaluations (haematology, clinical chemistry and urinalysis) were performed with all surviving animals subjected to complete gross necropsy and full histopathology. Under the conditions of this study the NOAEL is deemed to be 1000 mg/kg bw/day for both males and females based on the absence of adverse effects at any dose level. The observed increased absolute and relative liver weights (at equal to and greater than 500 mg/kg bw/day), with associated histopathology (hepatocellular centrilobular hypertrophy at 1000 mg/kg bw/day) were considered to be not adverse. Repeat dose inhalation: The potential repeat dose toxicity of MeTHF following sub-chronic (90 day) repeat dose inhalation exposure to young male and female Han Wistar rats (10 animals/sex/group) was investigated. Following a range-finder assessment, MeTHF was administered via nose only inhalation at doses of 0, 2, 4.5, 10 mg/L, 6 hours/day, 5 (weeks 1 to 12) or 7 (week 13) days a week.       Under the conditions of this study the NOAEC is deemed to be >9.96 mg/L (deemed to be the maximum tolerated dose) in males and females based on no adverse effects observed. Clinical signs (abnormal gait, salivation and higher low beam activity scores) and a slight effect on body weight, food consumption and water consumption was seen for animals exposed to 9.96 mg/L. In addition, irregular oestrous cycles were seen in all treated groups and a shift in the regular cycle length, from 4 to 5 days, was observed for females exposed to 9.96 mg/L. All changes were considered non-adverse. There were no microscopic changes attributable to the test item.       Repeat dose dermal:   No study has been conducted. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a335ce87-3fa8-491c-a358-f850a9beb6a7/documents/5f303494-54af-4fc2-8a59-86d9c246cfd4_ff3ad7a4-3792-416a-9756-702a4ffee565.html,,,,,, Tetrahydro-2-methylfuran,96-47-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a335ce87-3fa8-491c-a358-f850a9beb6a7/documents/5f303494-54af-4fc2-8a59-86d9c246cfd4_ff3ad7a4-3792-416a-9756-702a4ffee565.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tetrahydro-2-methylfuran,96-47-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a335ce87-3fa8-491c-a358-f850a9beb6a7/documents/5f303494-54af-4fc2-8a59-86d9c246cfd4_ff3ad7a4-3792-416a-9756-702a4ffee565.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,> 9.96 mg/L,, Tetrahydro-2-methylfuran,96-47-9," The acute oral LD50 was estimated to be in the range of 300 - 2000 mg/kg bodyweight, as determined in a reliable study conducted according to current OECD guideline and in compliance with CLP (Harlan 2012). An acute inhalation LC50 of 1485 ppm (equivalent 5.2 mg/l) bw is reported in a reliable study conducted according to a protocol equivalent to current guideline, but not in compliance with GLP (Terrill, 1989). An acute dermal LD50 value of >2000 mg/kg bw is reported in a reliable study conducted according to current OECD guideline and in compliance with GLP (Harlan 2013). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a335ce87-3fa8-491c-a358-f850a9beb6a7/documents/4b14c2eb-d647-4ce0-8a0b-9ea265326379_ff3ad7a4-3792-416a-9756-702a4ffee565.html,,,,,, Tetrahydro-2-methylfuran,96-47-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a335ce87-3fa8-491c-a358-f850a9beb6a7/documents/4b14c2eb-d647-4ce0-8a0b-9ea265326379_ff3ad7a4-3792-416a-9756-702a4ffee565.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, Tetrahydro-2-methylfuran,96-47-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a335ce87-3fa8-491c-a358-f850a9beb6a7/documents/4b14c2eb-d647-4ce0-8a0b-9ea265326379_ff3ad7a4-3792-416a-9756-702a4ffee565.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Tetrahydro-2-methylfuran,96-47-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a335ce87-3fa8-491c-a358-f850a9beb6a7/documents/4b14c2eb-d647-4ce0-8a0b-9ea265326379_ff3ad7a4-3792-416a-9756-702a4ffee565.html,,inhalation,LC50,22 mg/L,, Tetrahydro-3-methylfuran,13423-15-9,"The subacute and subchronic repeated-dose inhalation toxicityof tetrahydro-3-methylfuran (3-methyl-THF) has been adequately characterized by read-across to a closely related substance, tetrahydrofuran (CAS# 109-99-9). Repeated-dose drinking water toxicity studies in rats indicate tetrahydrofuran is of low toxicity. The subacute and subchronic toxicity of tetrahydrofuran in rats and mice is generally moderate to low following repeated-dose inhalation exposures. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f00ae8bd-0458-48f1-99da-3309c2b449ff/documents/IUC5-a13bc331-487c-433f-b24f-b7d6938996da_df16038c-5361-4a6f-bdd9-0932b6362941.html,,,,,, Tetrahydro-3-methylfuran,13423-15-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f00ae8bd-0458-48f1-99da-3309c2b449ff/documents/IUC5-a13bc331-487c-433f-b24f-b7d6938996da_df16038c-5361-4a6f-bdd9-0932b6362941.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Tetrahydro-3-methylfuran,13423-15-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f00ae8bd-0458-48f1-99da-3309c2b449ff/documents/IUC5-a13bc331-487c-433f-b24f-b7d6938996da_df16038c-5361-4a6f-bdd9-0932b6362941.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"2,114 mg/m3",,mouse Tetrahydro-3-methylfuran,13423-15-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f00ae8bd-0458-48f1-99da-3309c2b449ff/documents/IUC5-a13bc331-487c-433f-b24f-b7d6938996da_df16038c-5361-4a6f-bdd9-0932b6362941.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"2,114 mg/m3",no adverse effect observed,mouse Tetrahydro-3-methylfuran,13423-15-9,"The oral Approximate Lethal Dose (ALD) is 5000 mg/kg, which is expected to equate to an LD50 between 3500-5000 mg/kg.The inhalation Approximate Lethal Concentration (ALC) is >6700 PPM.The dermal LD50 is >2000 mg/kg-bw based on read-across to the analog substance tetrahydrofuran. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f00ae8bd-0458-48f1-99da-3309c2b449ff/documents/IUC5-c9fac4b3-8b5f-4722-8290-2b81d986d9fc_df16038c-5361-4a6f-bdd9-0932b6362941.html,,,,,, Tetrahydro-4-methyl-2H-pyran,4717-96-8,"28-day and 90-day oral toxicity studies conducted in rats are available for the test substance MTHP. In the GLP, test guideline compliant 28-day repeat dose oral study, rats produced liver enlargement as the main toxicological effect. High dose males (500 mg/kg bw/day) also showed increased relative kidney weight, without any associated histopathology and reduced motor activity (without associated histopathology), with high dose group females showing a significant increase in water intake, with significantly reduced urine osmolality. These effects were all reversible following withdrawal of administration. Histopathological liver changes were in all cases associated with liver enlargement and liver enzyme induction (hypertrophy of centrilobular hepatocyte) In the GLP compliant 90-day repeat dose oral toxicity study according to OECD 408, no mortality and adverse effects on clinical signs, grip strength, motor activity, body weights, food consumption, ophthalmology, clinical pathology (urinalysis, hematology, coagulation, blood chemistry, and hormone analysis [T3, T4, and TSH]), organ weights, gross pathology, and histopathology were observed. The NOAEL is 250 mg/kg bw/day for both sexes under condition of this study. Based on the results of both studies it could be concluded that adversity related to the test substance exposure is observed only at high dose (500 mg/kg bw/day). Therefore, the NOAEL of 250 mg/kg bw/day could be used as key value for chemical safety assessment. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7f675d34-c8ec-4fba-9718-121de0ee29d6/documents/0cbe4ed1-fcf4-4bb7-8bff-b2aaaa84c640_2fac1dee-b123-4dc8-9518-c50bdf88da2e.html,,,,,, Tetrahydro-4-methyl-2H-pyran,4717-96-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7f675d34-c8ec-4fba-9718-121de0ee29d6/documents/0cbe4ed1-fcf4-4bb7-8bff-b2aaaa84c640_2fac1dee-b123-4dc8-9518-c50bdf88da2e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,120 mg/kg bw/day,,rat Tetrahydro-4-methyl-2H-pyran,4717-96-8,The acute toxicity studies were waived based on the skin corrositivy of Tetrahydro-4 -methyl-2H-pyran. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7f675d34-c8ec-4fba-9718-121de0ee29d6/documents/f9ab4678-30fd-43c7-b6fd-43c8fbc2dce7_2fac1dee-b123-4dc8-9518-c50bdf88da2e.html,,,,,, Tetrahydro-4-methylphthalic anhydride,34090-76-1,"Oral:A NOAEL of 100 mg/kg bw/day was determined in a combined repeated dose/reproduction toxicity study (OECD 422) in rats based on changes in clinical chemistry parameters, changes in organ weights and inflammation of the forestomach mucosa.Dermal and inhalation:In accordance with column 2 of REACH Annex IX, the test repeated dose toxicity after dermal exposure (required in section 8.6) does not need to be conducted because there is another repeated toxicity robust study available for the oral route. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1f03b045-d262-427a-9852-14bd671bf960/documents/IUC5-2049baa3-e0b7-43ae-8305-9d8378732891_67bc3cbf-6d6e-4992-a582-378d964a90cb.html,,,,,, Tetrahydro-4-methylphthalic anhydride,34090-76-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1f03b045-d262-427a-9852-14bd671bf960/documents/IUC5-2049baa3-e0b7-43ae-8305-9d8378732891_67bc3cbf-6d6e-4992-a582-378d964a90cb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Tetrahydro-4-methylphthalic anhydride,34090-76-1,"Oral:Oral LD50 values were >2000 mg/kg for rat. The major toxicity was squamous hyperplasia of the forestomach.Dermal:The acute dermal median lethal dose (LD50) of the test material, tetrahydromethylphthalic anhydride, in the Sprague-Dawley strain rat was found to be greater than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f03b045-d262-427a-9852-14bd671bf960/documents/IUC5-20eb873c-f10b-40eb-95f2-4379157d9148_67bc3cbf-6d6e-4992-a582-378d964a90cb.html,,,,,, Tetrahydro-4-methylphthalic anhydride,34090-76-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f03b045-d262-427a-9852-14bd671bf960/documents/IUC5-20eb873c-f10b-40eb-95f2-4379157d9148_67bc3cbf-6d6e-4992-a582-378d964a90cb.html,,oral,LD50,"2,000 mg/kg bw",, Tetrahydro-4-methylphthalic anhydride,34090-76-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f03b045-d262-427a-9852-14bd671bf960/documents/IUC5-20eb873c-f10b-40eb-95f2-4379157d9148_67bc3cbf-6d6e-4992-a582-378d964a90cb.html,,dermal,LD50,"2,000 mg/kg bw",, Tetrahydrofurfuryl acrylate,2399-48-6," No repeated toxicity study is available on the registered substance (THFA). However a combined repeated dose and reproduction / developmental screening in available on the analogue substance (THFMA) : in which the NOAEL for the systemic effects is higher than 300 mg/kg bw/d. And a 90 -day repeated toxicity study is available on a metabolite of THFA : THF alcohol, in which the NOAEL is of 35 and 84 mg/kg bw/day in male and female rats respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f3d6ba2-db39-459b-b859-974906be6099/documents/4c0d8af9-5de9-4e70-af28-cb26970ccc22_58c6f838-c013-4602-8a2f-ff4bbf5ed37c.html,,,,,, Tetrahydrofurfuryl acrylate,2399-48-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6f3d6ba2-db39-459b-b859-974906be6099/documents/4c0d8af9-5de9-4e70-af28-cb26970ccc22_58c6f838-c013-4602-8a2f-ff4bbf5ed37c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,35 mg/kg bw/day,,rat Tetrahydrofurfuryl acrylate,2399-48-6," An acute toxicity study by oral route is available on tetrahydrofurfuryl acrylate. The results showed a LD50 of 928 mg/kg in rats indicating that the test substance is harmful after a single administration by oral route. No acute toxicity study is available by dermal route and inhalation, because tetrahydrofurfuryl acrylate is a skin corrosive substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f3d6ba2-db39-459b-b859-974906be6099/documents/d728af1d-1232-4c7b-93ef-8fea51e5201b_58c6f838-c013-4602-8a2f-ff4bbf5ed37c.html,,,,,, Tetrahydrofurfuryl acrylate,2399-48-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6f3d6ba2-db39-459b-b859-974906be6099/documents/d728af1d-1232-4c7b-93ef-8fea51e5201b_58c6f838-c013-4602-8a2f-ff4bbf5ed37c.html,,oral,LD50,928 mg/kg bw,adverse effect observed, Tetrahydrophthalic anhydride,26266-63-7, The oral toxicity of tetrahydrophthalic Anhydride (THPA) over an exposure period of 4 consecutive weeks and recovery from any potential treatment-related effects over a period of 2 consecutive weeks has been investigated. Methods were in accordance with OECD/EU test guidelines. No clinical signs of toxicity were observed and no significant variations were observed in haematology and clinical chemistry parameters. The high dose of 600 mg/kg/day was considered to be the No Observed Adverse Effect Level (NOAEL) for systemic toxicity and the low dose of 100 mg/kg/day was considered to be the No Observed Adverse Effect Level (NOAEL) for local effects. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a7de4ee-af2e-4dc6-bc89-a9cd0e6ae73e/documents/a6a31879-952c-4e4a-9c4d-8600b9cbedfb_9ac26764-1167-4cd0-8987-d04ce43c3c2b.html,,,,,, Tetrahydrophthalic anhydride,26266-63-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8a7de4ee-af2e-4dc6-bc89-a9cd0e6ae73e/documents/a6a31879-952c-4e4a-9c4d-8600b9cbedfb_9ac26764-1167-4cd0-8987-d04ce43c3c2b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat Tetrahydrophthalic anhydride,26266-63-7, Acute toxicity: Oral - LD50: <2000 mg/kg Dermal - LD50: > 2000 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a7de4ee-af2e-4dc6-bc89-a9cd0e6ae73e/documents/e5f3cefa-910f-4984-8987-6998f0394f38_9ac26764-1167-4cd0-8987-d04ce43c3c2b.html,,,,,, Tetrahydrophthalic anhydride,26266-63-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8a7de4ee-af2e-4dc6-bc89-a9cd0e6ae73e/documents/e5f3cefa-910f-4984-8987-6998f0394f38_9ac26764-1167-4cd0-8987-d04ce43c3c2b.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, Tetrahydrothiophene,110-01-0,"Exposure of rats (6 hours/day, 5 days/week, 13 weeks) leads to a NOAEC for the clinical signs of irritation of 51 ppm (184 mg/m3) and a NOAEC for systemic effect higher than 1442 ppm (5201 mg/m3).   Oral route There is no repeated dose toxicity study by oral route on THT.   Dermal route There is no reliable repeated dose toxicity study by dermal route on THT.   Inhalation route Ten male and ten female Sprague-Dawley rats were whole-body exposed to analytical concentrations of 0, 51, 236 and 1442 ppm (184, 852 or 5201 mg/m3) tetrahydrothiophene (purity > 99%), six hours per day, five days per week for 13 weeks (Hardy, 1988). The study was performed according to the good laboratory practice and the OECD Test Guideline 413. The clinical symptoms of irritation (lacrimation, salivation, eyes closed) are a cluster of symptoms seen with increasing concentration. From 236 ppm, there was a more frequent occurrence of irritative symptoms (eyes closed). The significance of the symptoms of ""licking the inside mouth and ""shake his head"" is unclear and questionable. The animals of the 1442 ppm group and the males of 236 ppm group drank more water than the animals in the control group. Ophthalmological examinations were unremarkable. In females of the 236 and 1442 ppm groups, the hematological parameters showed small differences compared to the control animals, but these changes were considered as not toxicologically significant, excepted an increase of white blood cells and lymphocytes at 1442 ppm. There was also a slight, not toxicologically significant increase in pH urine in females at 1442 ppm. Macroscopic examination and the determination of organ weights provided no abnormal findings. A minimal increase in liver weights was observed in females exposed to 1442 ppm but this effect was not considered toxicologically relevant. Histopathological examinations was performed on the lungs of all animals and on some other tissues of the control and 1442 ppm group animals. This included tissues from the nasal cavity (rostral and caudal). No histopathological changes were observed in any of the tissues examined that were considered to be related to treatment with THT. Free blood in sinuses was observed in one male animal of the 1442 ppm group and sinusoidal free blood in one female of the control group. These changes were considered as random. The NOAEC for the clinical signs of local irritation was 51 ppm (184 mg/m3) and the NOAEC for systemic effect was higher than 1442 ppm (5201 mg/m3). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1bb1d540-5c27-42a4-a89d-d0f995663eda/documents/IUC5-b2bd120b-f26c-497c-aea8-b5c7dea64304_a117a7d3-4917-4840-b64a-ca02c3f887a4.html,,,,,, Tetrahydrothiophene,110-01-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1bb1d540-5c27-42a4-a89d-d0f995663eda/documents/IUC5-b2bd120b-f26c-497c-aea8-b5c7dea64304_a117a7d3-4917-4840-b64a-ca02c3f887a4.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"5,201 mg/m3",,rat Tetrahydrothiophene,110-01-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1bb1d540-5c27-42a4-a89d-d0f995663eda/documents/IUC5-b2bd120b-f26c-497c-aea8-b5c7dea64304_a117a7d3-4917-4840-b64a-ca02c3f887a4.html,Repeated dose toxicity – local effects,inhalation,NOAEC,184 mg/m3,adverse effect observed,rat Tetrahydrothiophene,110-01-0," The acute oral median lethal dosage (LD50) in rats was 1,850 mg/kg. Signs of reaction to treatment included tremors, ataxia, respiratory abnormalities, inappetence and body weight loss. Recovery was complete within a few days. The dermal LD0 in rabbits was in excess of 2,000 mg/kg. The acute inhalation median lethal concentration (LC50) in rats (4-hour exposure) was 6,270 ppm (22572 mg/m3). Signs included secretory increases, respiratory abnormalities and body weight losses.   Oral route In an acute oral toxicity study performed according to EPA guideline #OTS 798.1175 and GLP (Auletta, 1985), Tetrahydrothiophene was administered to male and female Sprague-Dawley rats at dose levels of 800, 1000, 1250, 1600, 2000, 3125 mg/kg. Most surviving males exhibited weight gains at Day 7, although several females in the 1000, 1250 and 1600 mg/kg groups showed slight weight losses. All surviving gained weight between Days 7 and 14; gains were generally comparable among groups. Pharmacological and toxicological signs seen in all groups during the 24 hours after dosing included ataxia, tremors, hypoactivity and/or prostration, oral discharge, various respiratory abnormalities. Postmortem examinations of animals which were found dead revealed a variety of changes, primarily in the lungs and gastrointestinal tract. The LD50’s were 2000 (1387-2613) mg/kg, 1750 (1268-2232) mg/kg and 1850 (1547-2153) mg/kg for male, female and combined sex rats, respectively.   Inhalation A series of groups consisting of five male and five female Sprague-Dawley rats was whole-body exposed to tetrahydrothiophene vapors for four hours at mean analytical levels in the range of 3090 to 6300 ppm (11142 to 22718 mg/m3). The study was performed according to EPA guideline #OPP 81-3 and GLP (Terrill, 1986). Signs attributable to treatment included death, increased incidences of secretory responses, respiratory distress, reduced activity, matted coat, prostration, poor condition, ano-genital area staining and loss of body weight. Overall, the time-to-onset and time-to-recovery of these signs appeared to be related to exposure concentration. The resultant median lethal concentration values were 6270 ppm (22572 mg/m3) for the combined sexes.   Sprague-Dawley derived rats (5/sex/group) were exposed by inhalation for six hours at analytical concentrations of 0 or 1011 ppm (3640 mg/m3) vapour of tetrahydrothiophene (Daly, 1986) and were observed for 7 days. Detailed physical examinations were conducted daily, post-exposure, on all animals. Body weight measurements were recorded pretest, the first, third and fifth days, and before necropsy. On Test Day 8, all survivors were sacrificed and complete gross postmortem examinations and histopathological evaluations of selected tissues were conducted on all animals. No treatment-related deaths occurred during the study. Increased secretory responses, respiratory distress and reduced activity were observed during both exposure and non-exposure periods. The relationship between incidence and exposure concentration was not sharply defined and it was concluded the findings might be more of a physiological response to the test substance, which is a mal-odorant, than a toxicological response. In the lungs, interstitial inflammation and concomitant alveolar emphysema, while of comparable incidence in the treated and control animals, tended to be somewhat more severe in the treated animals. Collapsed and/or atelectatic alveoli were observed somewhat more frequently in the lungs of the treated animals than in their comparable controls; the toxicological significance of this finding, if any, remains equivocal. Results for body weight determinations were considered unremarkable. From the clinical signs observed during exposure a LOAEC of 1011 ppm (3640 mg/m3) can be established for the local irritation of the respiratory tract.   Dermal In an acute dermal toxicity study performed according to EPA guideline #OTS 798.1100 and GLP (Auletta, 1985), tetrahydrothiophene was administered to male and female New-Zealand rabbits at the dose level of 2000 mg/kg. All animals survived throughout the study. Most animals exhibited severe dermal effects at the dose site (necrosis followed by eschar formation, fissuring and/or exfoliation of the eschar tissue) which persisted throughout the study. Most animals exhibited hyperpnea on the day of dosing. Other signs seen in one or two animals on the day of dosing included fine tremors, nasal discharge, dyspnea, arythmic respiration and red eyes. Gross postmortem observations confirmed the presence of dermal lesions discussed previously. Unusual observations included surface irregularities (wrinkling) of the spleen in five animals, discoloured kidneys (mottled tan) in three animals and fissures in the liver in two animals. The dermal LD0 of tetrahydrothiophene in rabbits is greater than 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bb1d540-5c27-42a4-a89d-d0f995663eda/documents/IUC5-acb362a7-efe4-44a3-bfc5-9d9b82cac749_a117a7d3-4917-4840-b64a-ca02c3f887a4.html,,,,,, Tetrahydrothiophene,110-01-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bb1d540-5c27-42a4-a89d-d0f995663eda/documents/IUC5-acb362a7-efe4-44a3-bfc5-9d9b82cac749_a117a7d3-4917-4840-b64a-ca02c3f887a4.html,,oral,LD50,"1,850 mg/kg bw",adverse effect observed, Tetrahydrothiophene,110-01-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bb1d540-5c27-42a4-a89d-d0f995663eda/documents/IUC5-acb362a7-efe4-44a3-bfc5-9d9b82cac749_a117a7d3-4917-4840-b64a-ca02c3f887a4.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Tetrahydrothiophene,110-01-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1bb1d540-5c27-42a4-a89d-d0f995663eda/documents/IUC5-acb362a7-efe4-44a3-bfc5-9d9b82cac749_a117a7d3-4917-4840-b64a-ca02c3f887a4.html,,inhalation,LC50,"22,572 mg/m3",adverse effect observed, "Tetrahydrothiophene 1,1-dioxide",126-33-0," In the 90-day repeated dose oral toxicity study with Sulfolane, conducted according to the appropriate OECD 408 Test Guideline and in compliane with GLP, the study report concluded the NOEL level for females and males to be 25 mg/L and 100 mg/L drinking water, respectively, equivalent to 2.9 and 8.8 mg/kg bw/day (Huntingdon Life Sciences, 2001). The overall NOAEL is 2.9 mg/kg bw/day based on reduced immunological parameters in felames. The subchronic oral (28-day gavage) NOAEL for sulfolane in rats is 200 mg/kg bw/day.  Kidney effects seen in male rats at this dose are considered to be indicative of alpha-2u-nephropathy, a male rat-specific effect that is not considered relevant to humans.  The subchronic inhalation (90-days) NOAEC for sulfolane in rats is 20 mg/m3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/256991cf-0a1f-42d7-b2b7-a00fa3f63d66/documents/IUC5-439a0a6b-f6ef-4168-b4c5-e599cfbcfa0f_ac0bee9e-432b-4bbb-b07f-612029d589b3.html,,,,,, "Tetrahydrothiophene 1,1-dioxide",126-33-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/256991cf-0a1f-42d7-b2b7-a00fa3f63d66/documents/IUC5-439a0a6b-f6ef-4168-b4c5-e599cfbcfa0f_ac0bee9e-432b-4bbb-b07f-612029d589b3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,2.9 mg/kg bw/day,,rat "Tetrahydrothiophene 1,1-dioxide",126-33-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/256991cf-0a1f-42d7-b2b7-a00fa3f63d66/documents/IUC5-439a0a6b-f6ef-4168-b4c5-e599cfbcfa0f_ac0bee9e-432b-4bbb-b07f-612029d589b3.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,20 mg/m3,,rat "Tetrahydrothiophene 1,1-dioxide",126-33-0," Acute oral LD50 (rat): 2068 mg/kg Acute dermal LD50 (rat): >2000mg/kg Acute inhalation LC50 (rat, 4-hr): >12,000 mg/m3 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/256991cf-0a1f-42d7-b2b7-a00fa3f63d66/documents/IUC5-ce710db5-1d01-4925-a4b2-cea0f339666f_ac0bee9e-432b-4bbb-b07f-612029d589b3.html,,,,,, "Tetrahydrothiophene 1,1-dioxide",126-33-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/256991cf-0a1f-42d7-b2b7-a00fa3f63d66/documents/IUC5-ce710db5-1d01-4925-a4b2-cea0f339666f_ac0bee9e-432b-4bbb-b07f-612029d589b3.html,,oral,LD50,"2,068 mg/kg bw",no adverse effect observed, "Tetrahydrothiophene 1,1-dioxide",126-33-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/256991cf-0a1f-42d7-b2b7-a00fa3f63d66/documents/IUC5-ce710db5-1d01-4925-a4b2-cea0f339666f_ac0bee9e-432b-4bbb-b07f-612029d589b3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetrahydrothiophene 1,1-dioxide",126-33-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/256991cf-0a1f-42d7-b2b7-a00fa3f63d66/documents/IUC5-ce710db5-1d01-4925-a4b2-cea0f339666f_ac0bee9e-432b-4bbb-b07f-612029d589b3.html,,inhalation,LC50,"12,000 mg/m3",no adverse effect observed, Tetrahydroxysilane,10193-36-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37a8cbad-9f95-4308-856c-a6628ff9aa6e/documents/089313ab-619a-42c4-83db-0fa6439a23af_91fb5cdb-383b-46a6-95f8-b39281c823a7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,227 mg/kg bw/day,,rat Tetrairon tris(pyrophosphate),10058-44-3,No studies are provided for the endpoint 'repeated dose toxicity'. The standard testing requirement for chemicals manufactured or imported into the EU in quantities of >100 have been adapted on the basis that there is sufficient data to permit a robust conclusion on possibility of specific target organ toxicity as a result of repeated exposure. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47ba06b2-46de-4edd-8f40-d7d78e0e2db2/documents/IUC5-05c9e43d-d69c-4418-bcd3-86aaee22a845_a9454232-0c29-4e4c-8b98-52e6bc5c962b.html,,,,,, Tetrairon tris(pyrophosphate),10058-44-3,"Key studies are available for acute oral and acute inhalation toxicity. These studies are performed under the conditions of GLP and to an appropriate OECD guideline. As such, these studies are considered to be adequate and reliable for use a key studies for the purpose of REACH Registration and classification and labelling in accordance with EU CLP. It is not considered necessary to provide acute dermal toxicity data on the basis of the physiochemical and toxicological properties of tetrairon tris(pyrophosphate). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47ba06b2-46de-4edd-8f40-d7d78e0e2db2/documents/IUC5-0eeafed7-aaf0-417a-bf6c-ad8386df0215_a9454232-0c29-4e4c-8b98-52e6bc5c962b.html,,,,,, Tetraisopropyl methylenebisphosphonate,1660-95-3,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): LD50 > 500 mg/kg Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): LD50 > 1000 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d3c17971-e12e-4442-b02b-13d1460243b1/documents/IUC5-d48d1c76-db67-4a29-bc06-94779da9b538_a81c09d1-1e8a-4f76-b18e-107b483e6fab.html,,,,,, "tetrakis(2,6-dimethylphenyl)-m-phenylene biphosphate",139189-30-3,"Oral administration of the test material, PX-200, to rats for a period of up to 28 consectutive days , by gavage, at dose levels of 50, 250 and 1000 mg/kg/day resulted in apparently treatment-related macroscopic changes amongst two males at a dose level of 1000 mg/kg./day. Females dosed at 1000 mg/kg/day and males dosed at 250 mg/kg/day showed no toxicologically significant changes in the parameters measured and, as such the ""No Observed Effect Level"" (NOEL) was considered to be 250 mg/kg/day for males and 1000 mg/kg/day for females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06821ce8-b567-4534-b963-4e573da52cae/documents/a2f2d435-1d6d-4cd4-9224-303afe99a941_0b666461-6afd-4003-a788-a26253a5bab8.html,,,,,, "tetrakis(2,6-dimethylphenyl)-m-phenylene biphosphate",139189-30-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/06821ce8-b567-4534-b963-4e573da52cae/documents/a2f2d435-1d6d-4cd4-9224-303afe99a941_0b666461-6afd-4003-a788-a26253a5bab8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "tetrakis(2,6-dimethylphenyl)-m-phenylene biphosphate",139189-30-3,The submission substance was found to be non-toxic by both the oral and dermal routes of exposure duing OECD Guideline studies. A study to determine the inhalation toxicity of the substance has not been conducted due to it being considered scientifically unjustified. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06821ce8-b567-4534-b963-4e573da52cae/documents/IUC5-d6955c17-c81e-4279-aa00-4551cdad0b79_0b666461-6afd-4003-a788-a26253a5bab8.html,,,,,, "tetrakis(2,6-dimethylphenyl)-m-phenylene biphosphate",139189-30-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/06821ce8-b567-4534-b963-4e573da52cae/documents/IUC5-d6955c17-c81e-4279-aa00-4551cdad0b79_0b666461-6afd-4003-a788-a26253a5bab8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetrakis(2-butoxyethyl) orthosilicate,18765-38-3," In a Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test, conducted according to OECD TG 422 and in compliance with GLP, the reported NOAEL for tetrakis(2-butoxyethoxy) silane was 25 mg/kg bw/day for females and 100 mg/kg bw/day for males based on histomorphological adverse effects observed in mid and high dose females and high dose males (Eurofins, 2016). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f4a19f1-26a6-4935-b94b-7f511a291db5/documents/860a2700-e904-42e9-ab8b-62970a20eba0_f5125267-17a3-4d5f-80cb-7a4059192c1a.html,,,,,, Tetrakis(2-butoxyethyl) orthosilicate,18765-38-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f4a19f1-26a6-4935-b94b-7f511a291db5/documents/860a2700-e904-42e9-ab8b-62970a20eba0_f5125267-17a3-4d5f-80cb-7a4059192c1a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Tetrakis(2-butoxyethyl) orthosilicate,18765-38-3, In key acute oral and dermal studies conducted according to appropriate guidelines and in compliance with GLP the LD50 was found to be > 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f4a19f1-26a6-4935-b94b-7f511a291db5/documents/d2c2b6bc-f056-4483-8f26-60ca95995910_f5125267-17a3-4d5f-80cb-7a4059192c1a.html,,,,,, Tetrakis(2-butoxyethyl) orthosilicate,18765-38-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f4a19f1-26a6-4935-b94b-7f511a291db5/documents/d2c2b6bc-f056-4483-8f26-60ca95995910_f5125267-17a3-4d5f-80cb-7a4059192c1a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetrakis(2-butoxyethyl) orthosilicate,18765-38-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f4a19f1-26a6-4935-b94b-7f511a291db5/documents/d2c2b6bc-f056-4483-8f26-60ca95995910_f5125267-17a3-4d5f-80cb-7a4059192c1a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetrakis(2-ethylbutyl) orthosilicate,78-13-7, Acute Toxicity - Oral LD50 >2000 mg/kg for rat (OECD TG 425). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/536545bd-4201-4399-adf5-907846f75fec/documents/77956140-8c9f-4237-959f-1dbd97927535_4cac3ea0-bbf7-4971-b3e9-69c077835035.html,,,,,, Tetrakis(2-ethylbutyl) orthosilicate,78-13-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/536545bd-4201-4399-adf5-907846f75fec/documents/77956140-8c9f-4237-959f-1dbd97927535_4cac3ea0-bbf7-4971-b3e9-69c077835035.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetrakis(2-ethylhexane-1,3-diolato)titanium",5575-43-9," Repeated toxicity testing was considered unnecessary since this substance undergoes immediate disintegration and there are sufficient data on cleavage product for the most relevant exposure route. The intrinsic properties of this substance after repeated administration are related to the main degradation product EHD. Here structurally similair alcohol, 2 -EH is used to assess hazards of repeated exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e97d673-0bca-430d-9cd9-24134e3fdcca/documents/6cdef6f1-368d-4a9c-90c4-d8d268ce2f0f_7a5ee241-cd20-457b-8950-054f1b4f45f4.html,,,,,, "Tetrakis(2-ethylhexane-1,3-diolato)titanium",5575-43-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e97d673-0bca-430d-9cd9-24134e3fdcca/documents/6cdef6f1-368d-4a9c-90c4-d8d268ce2f0f_7a5ee241-cd20-457b-8950-054f1b4f45f4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Tetrakis(2-ethylhexane-1,3-diolato)titanium",5575-43-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e97d673-0bca-430d-9cd9-24134e3fdcca/documents/6cdef6f1-368d-4a9c-90c4-d8d268ce2f0f_7a5ee241-cd20-457b-8950-054f1b4f45f4.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,638 mg/m3,,rat "Tetrakis(2-ethylhexane-1,3-diolato)titanium",5575-43-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1e97d673-0bca-430d-9cd9-24134e3fdcca/documents/6cdef6f1-368d-4a9c-90c4-d8d268ce2f0f_7a5ee241-cd20-457b-8950-054f1b4f45f4.html,Repeated dose toxicity – local effects,inhalation,NOAEC,638 mg/m3,no adverse effect observed,rat "Tetrakis(2-ethylhexane-1,3-diolato)titanium",5575-43-9," The acute oral toxicity study with Titanium(4+) tetrakis(2-ethyl-3-hydroxyhexan-1- olate), Tyzor OGT in Wistar rats was conducted to assess the toxicological profile of the test item. The prepared dose formulation mixed with corn oil and was administered as a single oral gavage to overnight fasted (16 to 18 hours) three female rats (G1-FTS) at the dose of 300 mg/kg body weight. There were no clinical signs or mortality. Hence, three additional female rats were tested at the same dose of 300 mg/kg body weight (G1-STS). There were no clinical signs or mortality, as per the scheme - Annex 2c of the guideline, the treatment was initiated with the next higher dose of 2000 mg/kg bodyweight (G2-FTS). There were no clinical signs or mortality. Hence three additional female rats were tested at the same dose of 2000 mg/kg body weight (G2-STS). There were no clinical signs or mortality, no further test was required as per the scheme - Annex 2c of the OECD 423 guideline, hence the dosing was stopped. The rats were observed for mortality and clinical signs for 14 days post treatment. Body weights were recorded prior to dosing on day 1 and again on days 8 and 15. Necropsy was performed for all the rats at termination. All survived rats gained weight during experimental period. There were no gross pathological changes at necropsy. Based on the results of the present study, The LD50 of the test item, Tyzor OGT is 5000 mg/kg or unclassified as per the GHS. The test item is classified “Category 5” or Unclassified as per Globally Harmonized Classification system of Annex 2c of the Guideline, OECD 423. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e97d673-0bca-430d-9cd9-24134e3fdcca/documents/e332bcab-adf3-432e-9156-a814022632c6_7a5ee241-cd20-457b-8950-054f1b4f45f4.html,,,,,, "Tetrakis(2-ethylhexane-1,3-diolato)titanium",5575-43-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1e97d673-0bca-430d-9cd9-24134e3fdcca/documents/e332bcab-adf3-432e-9156-a814022632c6_7a5ee241-cd20-457b-8950-054f1b4f45f4.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Tetrakis(2-ethylhexyl) benzene-1,2,4,5-tetracarboxylate",3126-80-5," Read-across - Repeated dose oxicity: oral, OECD Guideline 407, 28 -day sub-acute toxicity, oral in rats: NOEL 1,000 mg/kg/bw ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29efd36d-311d-474d-bbee-8da00402f61c/documents/e80bd1c6-6207-47b9-901b-b257e500f752_b17af50f-0918-4788-a647-a7af55f96e77.html,,,,,, "Tetrakis(2-ethylhexyl) benzene-1,2,4,5-tetracarboxylate",3126-80-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/29efd36d-311d-474d-bbee-8da00402f61c/documents/e80bd1c6-6207-47b9-901b-b257e500f752_b17af50f-0918-4788-a647-a7af55f96e77.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Tetrakis(2-ethylhexyl) benzene-1,2,4,5-tetracarboxylate",3126-80-5," Read-across, OECD Guideline 401, Acute Oral Toxicity to rat: LD50 > 2000 mg/kg bw Read-across, Federal Insecticide, Fungicide, and Rodecticide Act, Part 163, Title 40; Code of the Federal Regulations 40 CRF 163.81., Acute Dermal Toxicity to rabbit: LD50 > 2000 ml/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29efd36d-311d-474d-bbee-8da00402f61c/documents/4d4c335e-1756-41ed-a943-80d1cf403a24_b17af50f-0918-4788-a647-a7af55f96e77.html,,,,,, "Tetrakis(2-ethylhexyl) benzene-1,2,4,5-tetracarboxylate",3126-80-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29efd36d-311d-474d-bbee-8da00402f61c/documents/4d4c335e-1756-41ed-a943-80d1cf403a24_b17af50f-0918-4788-a647-a7af55f96e77.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetrakis(2-ethylhexyl) benzene-1,2,4,5-tetracarboxylate",3126-80-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/29efd36d-311d-474d-bbee-8da00402f61c/documents/4d4c335e-1756-41ed-a943-80d1cf403a24_b17af50f-0918-4788-a647-a7af55f96e77.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetrakis(hydroxymethyl)phosphonium chloride,124-64-1,"chronic gavage rat LOAEL = 3.75 mg/kg bw/day (liver)chronic gavage mouse LOAEL = 7.5 mg/kg bw/day (liver)subchronic gavage rat/mouse NOAEL = 3.75 mg/kg bw/day (liver)chronic dermal mouse NOAEL = 50 mg/kg bw/day (no systemic effects); NOAEC = 0.25 mg/cm2 (skin irrit)subchronic dermal rabbit LOAEL = 50 mg/kg bw/day (general bad cond.); LOAEC = 10 mg/cm2 (skin irrit)subchronic dermal rat LOAEL = 50 mg/kg bw/day (bw loss); LOAEC = 15 mg/cm2 (skin irrit)repeated dose inhalation: waivedTHPC is characterized by primary local toxicity (irritation or corrosion) depending on the concentration applied. The route of exposure is accountable for substance related effects. General systemic effects are considered to be caused by severe and/or repeated local adverse effects.Systemic toxicity:Ingestion of THPC in subchronic or chronic studies caused hepatocytic vacuolar degeneration in rats and mice and decreased survival in rats. The liver was the organ affected by oral exposure. Subchronic studies: NOEL = 3.75 mg/kg; Chronic studies LOEL = 3.75 mg/kg.Dermal exposure with THPC in mice caused body weight loss, paralysis of hindleggs and death at doses causing severe skin necrosis. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55b8b7ba-e929-49fc-8782-bb7b6329a62a/documents/IUC5-ae762541-1e53-4ac6-8edf-8e15cbe31f60_2f9f728a-9e7b-4828-80a9-b65041911c9f.html,,,,,, Tetrakis(hydroxymethyl)phosphonium chloride,124-64-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55b8b7ba-e929-49fc-8782-bb7b6329a62a/documents/IUC5-ae762541-1e53-4ac6-8edf-8e15cbe31f60_2f9f728a-9e7b-4828-80a9-b65041911c9f.html,Chronic toxicity – systemic effects,oral,LOAEL,3.75 mg/kg bw/day,,rat Tetrakis(hydroxymethyl)phosphonium chloride,124-64-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55b8b7ba-e929-49fc-8782-bb7b6329a62a/documents/IUC5-ae762541-1e53-4ac6-8edf-8e15cbe31f60_2f9f728a-9e7b-4828-80a9-b65041911c9f.html,Chronic toxicity – systemic effects,dermal,NOAEL,50 mg/kg bw/day,,mouse Tetrakis(hydroxymethyl)phosphonium chloride,124-64-1,rat oral LD50 = 161 mg/kg (NTP 1987)rat dermal LD50 > 1500 mg/kg bw (Ulsamer 1980)rabbit dermal LD50 = 281 mg/kg (Am.Cyanamid 1975/CPSC 2001)inhalation LC50 (test waived: corrosive + limited exposure) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55b8b7ba-e929-49fc-8782-bb7b6329a62a/documents/IUC5-9896be4d-a872-4d86-bc24-e28a41508aa4_2f9f728a-9e7b-4828-80a9-b65041911c9f.html,,,,,, Tetrakis(hydroxymethyl)phosphonium chloride,124-64-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55b8b7ba-e929-49fc-8782-bb7b6329a62a/documents/IUC5-9896be4d-a872-4d86-bc24-e28a41508aa4_2f9f728a-9e7b-4828-80a9-b65041911c9f.html,,oral,LD50,161 mg/kg bw,adverse effect observed, Tetrakis(hydroxymethyl)phosphonium chloride,124-64-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55b8b7ba-e929-49fc-8782-bb7b6329a62a/documents/IUC5-9896be4d-a872-4d86-bc24-e28a41508aa4_2f9f728a-9e7b-4828-80a9-b65041911c9f.html,,dermal,LD50,281 mg/kg bw,adverse effect observed, "Tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea",27104-30-9,"THPC-urea, like THPC is characterized by primary local toxicity (irritation or corrosion) depending on the concentration applied. The route of exposure is accountable for substance related effects. General systemic effects are considered to be secondary and maybe caused by repeated local adverse effects.Ingestion of THPC in subchronic or chronic studies caused hepatocytic vacuolar degeneration in rats and mice and decreased survival in rats. The liver was the organ affected by oral exposure. Subchronic studies: NOEL = 3.75 mg/kg-d; Chronic studies LOEL = 3.75 mg/kg-d.In pregnant rabbits, the subacute oral local NOAEL = 2 mg/kg bw /day (low dose) based on changes of gastrointestinal mucosal lining whereas the systemic NOAEL = 30 mg/kg bw/day (mid dose) based on body weight loss. (Factor 15)Repeated dermal exposure studies revealed primary local toxicity of THPC. - In mice, the chronic dermal local NOEL = 0.5 mg/cm2 in mice (corresponding to 100 mg/kg bw/day) based on minimal dermal irritation (no systemic effects).- in rats, the subacute dermal local LOAEL = 15 mg/cm2 based on severe skin necrosis (corresponding to a systemic LOAEL = 450 mg/kg bw/day based on body weight loss.- in rabbits, the subacute dermal local LOAEL = 9.4 mg/cm2 severe skin necrosis (corresponding to a systemic LOAEL = 50 mg/kg bw/day based on declined condition. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f00644ca-b765-4b36-9eaf-02867e7ac102/documents/IUC5-e33c24a6-680c-4000-a321-06cdcee760ae_eaa816ab-bdde-44c5-bd02-b269c5f570ed.html,,,,,, "Tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea",27104-30-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f00644ca-b765-4b36-9eaf-02867e7ac102/documents/IUC5-e33c24a6-680c-4000-a321-06cdcee760ae_eaa816ab-bdde-44c5-bd02-b269c5f570ed.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rabbit "Tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea",27104-30-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f00644ca-b765-4b36-9eaf-02867e7ac102/documents/IUC5-e33c24a6-680c-4000-a321-06cdcee760ae_eaa816ab-bdde-44c5-bd02-b269c5f570ed.html,Chronic toxicity – systemic effects,dermal,NOAEL,100 mg/kg bw/day,,mouse "Tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea",27104-30-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f00644ca-b765-4b36-9eaf-02867e7ac102/documents/IUC5-e33c24a6-680c-4000-a321-06cdcee760ae_eaa816ab-bdde-44c5-bd02-b269c5f570ed.html,Repeated dose toxicity – local effects,dermal,NOAEL,0.25 mg/cm2,adverse effect observed,mouse "Tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea",27104-30-9,oral LD50 (rat) = 962 mg/kg bw (technical product)dermal LD50 (rat) > 2000 mg/kg bw (technical product)inhalation LC50: waived (exposure considerations) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f00644ca-b765-4b36-9eaf-02867e7ac102/documents/IUC5-a81aef04-292a-4399-8214-3da7f25e138c_eaa816ab-bdde-44c5-bd02-b269c5f570ed.html,,,,,, "Tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea",27104-30-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f00644ca-b765-4b36-9eaf-02867e7ac102/documents/IUC5-a81aef04-292a-4399-8214-3da7f25e138c_eaa816ab-bdde-44c5-bd02-b269c5f570ed.html,,oral,discriminating dose,500 mg/kg bw,adverse effect observed, "Tetrakis(hydroxymethyl)phosphonium chloride, oligomeric reaction products with urea",27104-30-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f00644ca-b765-4b36-9eaf-02867e7ac102/documents/IUC5-a81aef04-292a-4399-8214-3da7f25e138c_eaa816ab-bdde-44c5-bd02-b269c5f570ed.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, Tetrakis(hydroxymethyl)phosphonium sulphate(2:1),55566-30-8," - By dermal repeated exposure, THPS was too irritating to allow the calculation of a NOAEL/ LOAEL for systemic effects ( OECD 410, Kr.2). - No data are available on repeated dose toxicity by inhalation, however THPS is not volatile, having very low vapour pressure, and is not supplied for use in aerosol-generating applications. - By oral route, THPS was studied in rats, mice and dogs in subacute, subchronic and chronic tests. The key studies for derivation of an oral NOAEL for repeated exposure are 90-day oral studies in the rat (Hill, 1990) and dog (Braun, 2006). Hepatocyte cytoplasmic vacuolation was noted in the portal area of the liver in both species with apoptosis in hepatocytes of the dog only. Raised levels of liver enzymes ALTand AST were also noted in rat studies. The NOAEL derived in both of these studies was 0.75 mg/kg bw/day expressed as main ingredient. (For more details please read CSR available in section 13). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37b68830-d778-4a5a-a3b1-def100b83888/documents/4f2dae61-3ac1-4a93-8013-8e3c03186973_f4f72471-fbf8-4dec-9f86-44ce2d910f8c.html,,,,,, Tetrakis(hydroxymethyl)phosphonium sulphate(2:1),55566-30-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/37b68830-d778-4a5a-a3b1-def100b83888/documents/4f2dae61-3ac1-4a93-8013-8e3c03186973_f4f72471-fbf8-4dec-9f86-44ce2d910f8c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,0.75 mg/kg bw/day,,other:rat and dog. Tetrakis(hydroxymethyl)phosphonium sulphate(2:1),55566-30-8," Three key studies of reliability 1 have been identified for the three routes of exposure, the conclusions are the following: - oral toxicity: LD50/rat = 431 mg/kg bw (expressed as main ingredient; THPS 100%) and LD50/rat = 575 mg/kg bw (expressed as active substance, 75% in water), (OECD 401, Kr.1) - dermal toxicity: LD50/rat > 1500 mg/kg bw (expressed as main ingredient; THPS 100%) and LD50/rat > 2000 mg/mk bw (expressed as active substance, 75% in water), (OECD 402, Kr.1). - inhalation toxicity: LC50/rat (aerosol) = 0.443 mg/L (expressed as main ingredient; THPS 100%) and LC50/rat (aerosol) = 0.591 mg/L(expressed as active substance, 75% in water),(OECD 403, Kr.1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37b68830-d778-4a5a-a3b1-def100b83888/documents/0cd7109b-efe3-4344-9437-228b4d8a4fca_f4f72471-fbf8-4dec-9f86-44ce2d910f8c.html,,,,,, Tetrakis(hydroxymethyl)phosphonium sulphate(2:1),55566-30-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37b68830-d778-4a5a-a3b1-def100b83888/documents/0cd7109b-efe3-4344-9437-228b4d8a4fca_f4f72471-fbf8-4dec-9f86-44ce2d910f8c.html,,oral,LD50,575 mg/kg bw,adverse effect observed, Tetrakis(hydroxymethyl)phosphonium sulphate(2:1),55566-30-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/37b68830-d778-4a5a-a3b1-def100b83888/documents/0cd7109b-efe3-4344-9437-228b4d8a4fca_f4f72471-fbf8-4dec-9f86-44ce2d910f8c.html,,inhalation,LC50,0.591 ,adverse effect observed, Tetrakis(phenylmethyl)thioperoxydi(carbothioamide),10591-85-2,No treatment-related adverse effect was observed in the oral 28-day and 90-day repeated toxicity studies performed with the registered substance at up to 1000 mg/kg/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe0e2b36-5378-4608-bb5d-162a60ab0944/documents/505ed471-a955-4adf-b7be-a225d2589c02_3d284c8c-a83a-4541-b256-937b40b2853b.html,,,,,, Tetrakis(phenylmethyl)thioperoxydi(carbothioamide),10591-85-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe0e2b36-5378-4608-bb5d-162a60ab0944/documents/505ed471-a955-4adf-b7be-a225d2589c02_3d284c8c-a83a-4541-b256-937b40b2853b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tetrakis(phenylmethyl)thioperoxydi(carbothioamide),10591-85-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe0e2b36-5378-4608-bb5d-162a60ab0944/documents/505ed471-a955-4adf-b7be-a225d2589c02_3d284c8c-a83a-4541-b256-937b40b2853b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tetrakis(phenylmethyl)thioperoxydi(carbothioamide),10591-85-2,The acute toxicity of the registered substance was evaluated after oral and inhalation exposure in rats. No mortality was observed in both studies. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe0e2b36-5378-4608-bb5d-162a60ab0944/documents/10963c3d-4112-4774-a4f8-368cd1418430_3d284c8c-a83a-4541-b256-937b40b2853b.html,,,,,, Tetrakis(phenylmethyl)thioperoxydi(carbothioamide),10591-85-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe0e2b36-5378-4608-bb5d-162a60ab0944/documents/10963c3d-4112-4774-a4f8-368cd1418430_3d284c8c-a83a-4541-b256-937b40b2853b.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Tetrakis(phenylmethyl)thioperoxydi(carbothioamide),10591-85-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe0e2b36-5378-4608-bb5d-162a60ab0944/documents/10963c3d-4112-4774-a4f8-368cd1418430_3d284c8c-a83a-4541-b256-937b40b2853b.html,,inhalation,discriminating conc.,"5,030 mg/m3",no adverse effect observed, Tetrakis(tritolyl phosphite )nickel,35884-66-3,There is no information available on repeated dose toxicity. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/382d4448-2e11-437a-8be1-53feae20f8c2/documents/IUC5-0ba1629c-1847-425d-9a71-59684447ea50_17eea667-069d-48a7-a8db-becc480292ec.html,,,,,, Tetrakis(tritolyl phosphite )nickel,35884-66-3,LD50 (oral): 300 - 2000 mg/kg bwLD50 (dermal): 508 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/382d4448-2e11-437a-8be1-53feae20f8c2/documents/IUC5-fe63051f-48bb-4bcd-9931-4e3828fed07f_17eea667-069d-48a7-a8db-becc480292ec.html,,,,,, Tetrakis(tritolyl phosphite )nickel,35884-66-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/382d4448-2e11-437a-8be1-53feae20f8c2/documents/IUC5-fe63051f-48bb-4bcd-9931-4e3828fed07f_17eea667-069d-48a7-a8db-becc480292ec.html,,oral,discriminating dose,300 mg/kg bw,, Tetrakis(tritolyl phosphite )nickel,35884-66-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/382d4448-2e11-437a-8be1-53feae20f8c2/documents/IUC5-fe63051f-48bb-4bcd-9931-4e3828fed07f_17eea667-069d-48a7-a8db-becc480292ec.html,,dermal,LD50,508 mg/kg bw,, "Tetrakis[[2,2',2''-nitrilotris[ethanolato]](1-)-N,O]zirconium",101033-44-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5229bc74-9f5a-444a-8b88-372cf632caa1/documents/73d19585-c06d-4e5e-a37f-60799cdcca7b_8b806ca2-7779-44a5-a625-3ffff476661a.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Tetrakis[[2,2',2''-nitrilotris[ethanolato]](1-)-N,O]zirconium",101033-44-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5229bc74-9f5a-444a-8b88-372cf632caa1/documents/73d19585-c06d-4e5e-a37f-60799cdcca7b_8b806ca2-7779-44a5-a625-3ffff476661a.html,Chronic toxicity – systemic effects,dermal,NOAEL,250 mg/kg bw/day,,rat "Tetrakis[[2,2',2''-nitrilotris[ethanolato]](1-)-N,O]zirconium",101033-44-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5229bc74-9f5a-444a-8b88-372cf632caa1/documents/972970d0-112d-4363-b631-5186cde003dc_8b806ca2-7779-44a5-a625-3ffff476661a.html,,oral,LD50,"4,190 mg/kg bw",no adverse effect observed, "Tetrakis[[2,2',2''-nitrilotris[ethanolato]](1-)-N,O]zirconium",101033-44-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5229bc74-9f5a-444a-8b88-372cf632caa1/documents/972970d0-112d-4363-b631-5186cde003dc_8b806ca2-7779-44a5-a625-3ffff476661a.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Tetralead trioxide sulphate,12202-17-4," Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eeef3b7c-f197-4094-b97d-4bbe993b93a7/documents/55240df1-e7fa-4fe8-8269-766f9e1416fc_91d84560-52fc-4585-8542-12735a3eb838.html,,,,,, Tetralead trioxide sulphate,12202-17-4, Inorganic lead compounds do not exhibit toxicity in acute toxicity tests with experimental animals. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eeef3b7c-f197-4094-b97d-4bbe993b93a7/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_91d84560-52fc-4585-8542-12735a3eb838.html,,,,,, Tetralead trioxide sulphate,12202-17-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eeef3b7c-f197-4094-b97d-4bbe993b93a7/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_91d84560-52fc-4585-8542-12735a3eb838.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetralead trioxide sulphate,12202-17-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eeef3b7c-f197-4094-b97d-4bbe993b93a7/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_91d84560-52fc-4585-8542-12735a3eb838.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetralead trioxide sulphate,12202-17-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eeef3b7c-f197-4094-b97d-4bbe993b93a7/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_91d84560-52fc-4585-8542-12735a3eb838.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Tetralithium 5,5'-[vinylenebis[(3-sulphonato-4,1-phenylene)azo]]bis[3-methylsalicylate]",53523-90-3,"A dietary concentration of 1000 ppm is a clear NOAEL for the rat. Only the presence of hyaline droplets in male kidneys prevents an adjusted dietary concentration of 2500 ppm (highest dose tested) being classified as being a NOAEL and, given the non-relevance of this finding to man, this dietary level may be regarded as a NOAEL when assessing the hazard of the Test Item to man. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): In this repeated dose (28-day) feed study a NOAEL was found at 2500 ppm for female rats (eq. to 213 mg/kg bw) and a LOAEL at this concentration for male rats (eq. to 212 mg/kg bw). However, the finding observed in males at the LOAEL was an effect often seen in male rats due to accumulation of alpha 2µ-globulin, a major urinary protein in rats, when it binds to test item and clearance is retarded. This effect is not relevant for humans, since the protein alpha 2µ-globulin does not exist in humans. Therefore, the human relevant NOAEL from the study is 212 mg/kg. It is important to note that 2500 ppm was the highest dietary concentration that was practical to test, as higher levels were precluded due to the decreased food consumption considered to reflect the palatability of the dietary formulations (documented in the 14-day range finder study NR32HS) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d830ee3b-fc45-4885-9efe-d5ca0df58fc8/documents/6739be3f-6134-4ebf-853d-1a6360362287_f3ee984c-a58b-4b07-b4ac-07dca3ff8515.html,,,,,, "Tetralithium 5,5'-[vinylenebis[(3-sulphonato-4,1-phenylene)azo]]bis[3-methylsalicylate]",53523-90-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d830ee3b-fc45-4885-9efe-d5ca0df58fc8/documents/6739be3f-6134-4ebf-853d-1a6360362287_f3ee984c-a58b-4b07-b4ac-07dca3ff8515.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,212 mg/kg bw/day,,other:highest dose tested; human-relevant NOAEL from subacute rat study (OECD TG 407) "Tetramethyl 2,2'-[1,4-phenylenebis[imino(1-acetyl-2-oxoethane-1,2-diyl)azo]]bisterephthalate",68516-73-4, oral: subacute (screening): NOAEL = 1000 mg/kg bw/day (OECD 422) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c2976a6-a99b-4125-beeb-47b2bf181d75/documents/e84a8836-237b-4a75-89c0-2a5ff0ec393d_c3ad7872-f119-4960-94dc-6c9ed41bd3a0.html,,,,,, "Tetramethyl 2,2'-[1,4-phenylenebis[imino(1-acetyl-2-oxoethane-1,2-diyl)azo]]bisterephthalate",68516-73-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c2976a6-a99b-4125-beeb-47b2bf181d75/documents/e84a8836-237b-4a75-89c0-2a5ff0ec393d_c3ad7872-f119-4960-94dc-6c9ed41bd3a0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Tetramethyl 2,2'-[1,4-phenylenebis[imino(1-acetyl-2-oxoethane-1,2-diyl)azo]]bisterephthalate",68516-73-4," Oral: LD50 > 2000 mg/kg bw/day, OECD 423 Inhalative (dust): LC50 (4h, rat) > 1.7 mg/L air (highest concentration possible), OECD 403; read-across with CAS 5580-57-4 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c2976a6-a99b-4125-beeb-47b2bf181d75/documents/a5702ecc-d9c4-4057-ad2e-5a566fae94bb_c3ad7872-f119-4960-94dc-6c9ed41bd3a0.html,,,,,, "Tetramethyl 2,2'-[1,4-phenylenebis[imino(1-acetyl-2-oxoethane-1,2-diyl)azo]]bisterephthalate",68516-73-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c2976a6-a99b-4125-beeb-47b2bf181d75/documents/a5702ecc-d9c4-4057-ad2e-5a566fae94bb_c3ad7872-f119-4960-94dc-6c9ed41bd3a0.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Tetramethyl 2,2'-[1,4-phenylenebis[imino(1-acetyl-2-oxoethane-1,2-diyl)azo]]bisterephthalate",68516-73-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c2976a6-a99b-4125-beeb-47b2bf181d75/documents/a5702ecc-d9c4-4057-ad2e-5a566fae94bb_c3ad7872-f119-4960-94dc-6c9ed41bd3a0.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Tetramethyl 2,2'-[1,4-phenylenebis[imino(1-acetyl-2-oxoethane-1,2-diyl)azo]]bisterephthalate",68516-73-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c2976a6-a99b-4125-beeb-47b2bf181d75/documents/a5702ecc-d9c4-4057-ad2e-5a566fae94bb_c3ad7872-f119-4960-94dc-6c9ed41bd3a0.html,,inhalation,discriminating conc.,"1,700 mg/m3",no adverse effect observed, Tetramethyl orthosilicate,681-84-5,"In a 28-day inhalation study comparable to OECD test guidelines and to GLP (Dow Corning Corporation, 1987) the NOAEC for local effects of tetramethoxysilane in Sprague-Dawley rats was determined to be 10 ppm when exposed by the inhalation route six hours per day, five days per week for four consecutive weeks. The test substance was found to have a steep dose response curve with no effects at 10 ppm, very minimal effects at 15 ppm, moderate to severe effects at 30 ppm and severe effects and lethality at 45 ppm. Exposure-related morphological changes were typical of the local effects of a corrosive agent, and were limited to moist surfaces of the eye (cornea), and respiratory tract (nasal tissues, pharynx, larynx, trachea, bronchi and bronchioles). As all observed significant toxicological effects appeared to be secondary to the local effects the systemic NOAEC is considered to be 45 ppm. However, the overall NOAEC for the study is 15 ppm, based on local effects on the respiratory tract, since the effects at this dose level were minimal. There are no oral repeated dose toxicity data on tetramethyl orthosilicate, so good quality data on the structurally-related substance, tetraethyl orthosilicate have been read-across.In an OECD 422 study conducted to GLP (SEHSC, 2005), the parental NOAEL for tetraethylorthosilicate in rats was 50 mg/kg bw/day for the females and 10 mg/kg bw/day for the males, based on adverse effects on the kidneys. Degenerative/necrotic nephropathy was observed among the treated animals at the doses of 50 or 100 mg/kg bw/day. There are no dermal data. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0332640d-6f9e-456d-b467-0e7dfc55fc07/documents/IUC5-418c0dde-262a-4a51-b0d5-6a4455a4b33d_75a1418d-28fd-4742-b42d-b07bddb008cc.html,,,,,, Tetramethyl orthosilicate,681-84-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0332640d-6f9e-456d-b467-0e7dfc55fc07/documents/IUC5-418c0dde-262a-4a51-b0d5-6a4455a4b33d_75a1418d-28fd-4742-b42d-b07bddb008cc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Tetramethyl orthosilicate,681-84-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0332640d-6f9e-456d-b467-0e7dfc55fc07/documents/IUC5-418c0dde-262a-4a51-b0d5-6a4455a4b33d_75a1418d-28fd-4742-b42d-b07bddb008cc.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,279 mg/m3,,rat Tetramethyl orthosilicate,681-84-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0332640d-6f9e-456d-b467-0e7dfc55fc07/documents/IUC5-418c0dde-262a-4a51-b0d5-6a4455a4b33d_75a1418d-28fd-4742-b42d-b07bddb008cc.html,Repeated dose toxicity – local effects,inhalation,NOAEC,93 mg/m3,adverse effect observed,rat Tetramethyl orthosilicate,681-84-5,"In an acute inhalation study conducted using a protocol similar to OECD 403 and to GLP (Dow Corning Corporation, 1982), the LC50 for tetramethyl orthosilicate in Sprague-Dawley rats was 63 ppm (equivalent to 392 mg/m3). The main clinical sign observed in the post-exposure period (14 days) was gasping and coughing. Animals at the two higher exposure concentrations experienced loss of body weight. No deaths occurred at 31 ppm, there were three deaths at 50 ppm, and nine deaths at 88 ppm. All deaths occurred in the first week after exposure. The main macroscopic abnormality was lung damage and this was present in all animals. The extent of the damage ranged from small discrete foci to areas covering entire lobes of the lungs.There are no oral data on tetramethyl orthosilicate, so good quality data on the structurally-related substance, tetraethyl orthosilicate have been read-across.The study reports an oral LD50 value of >2500 mg/kg which was determined in a reliable study conducted according to OECD guideline 423, and in compliance with GLP (Bayer AG, 2001). There were no clinical signs or test substance related deaths.There are no reliable dermal data available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0332640d-6f9e-456d-b467-0e7dfc55fc07/documents/IUC5-ade17d67-89a9-439c-ace2-94664a34714f_75a1418d-28fd-4742-b42d-b07bddb008cc.html,,,,,, Tetramethyl orthosilicate,681-84-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0332640d-6f9e-456d-b467-0e7dfc55fc07/documents/IUC5-ade17d67-89a9-439c-ace2-94664a34714f_75a1418d-28fd-4742-b42d-b07bddb008cc.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Tetramethyl orthosilicate,681-84-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0332640d-6f9e-456d-b467-0e7dfc55fc07/documents/IUC5-ade17d67-89a9-439c-ace2-94664a34714f_75a1418d-28fd-4742-b42d-b07bddb008cc.html,,inhalation,LC50,392 mg/m3,adverse effect observed, Tetramethylammonium hydrogen phthalate,79723-02-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Study performed according to EC/OECD guidelines and GLP principles. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed1b3c78-e072-406c-b373-e310a576abcb/documents/IUC5-3314f984-473e-4c06-a646-1fe6763c35b2_fe591f9e-ace2-475c-a873-1dad36b149f6.html,,,,,, Tetramethylammonium hydrogen phthalate,79723-02-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed1b3c78-e072-406c-b373-e310a576abcb/documents/IUC5-3314f984-473e-4c06-a646-1fe6763c35b2_fe591f9e-ace2-475c-a873-1dad36b149f6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat Tetramethylammonium hydrogen phthalate,79723-02-7,"Reliable acute studies for the oral and dermal route are available, performed according to EC/ OECD guidelines and GLP principles. The acute oral LD50 of TMAP in the rat was calculated to be 105 (88 - 126) mg/kg bw. No mortalities were observed in the dermal toxicity test at 2000 mg/kg bw. It is of note that TMAP is the same test substance as TMHP (tetramethylammonium hydrogen phthalate). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed1b3c78-e072-406c-b373-e310a576abcb/documents/IUC5-ce0fad72-482a-4be9-9614-72406e614231_fe591f9e-ace2-475c-a873-1dad36b149f6.html,,,,,, Tetramethylammonium hydrogen phthalate,79723-02-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed1b3c78-e072-406c-b373-e310a576abcb/documents/IUC5-ce0fad72-482a-4be9-9614-72406e614231_fe591f9e-ace2-475c-a873-1dad36b149f6.html,,oral,LD50,100 mg/kg bw,adverse effect observed, Tetramethylammonium hydrogen phthalate,79723-02-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed1b3c78-e072-406c-b373-e310a576abcb/documents/IUC5-ce0fad72-482a-4be9-9614-72406e614231_fe591f9e-ace2-475c-a873-1dad36b149f6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetramethylammonium hydroxide,75-59-2,"One oral repeated dose study is available: MHLW 2001, resulting in a NOAEL of 5 mg/kg bw/d.Two dermal repeated dose studies are available: IITRI2000, a NOAEL for local effects was determined to be 5.5 mg/kg/day for males and 2.5 mg/kg/day for females. The NOAEL for systemic toxicity was found to be 10 mg/kg/day for both sexes. IBM1999 (reliability 4): a systemic NOAEL of 2.5 mg/kg bw for females and 5.5 mg/kg bw for males was established for TMAH. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalSystemicEffects.EndpointConclusion.DataBaseQuality): One reliable study is available, conducted according to OECD guideline and GLP principles. A second study with reliability 4 presented no clear data on local effects and lacked exminations on organ weights and microscopy. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityDermalLocalEffects.EndpointConclusion.DataBaseQuality): One reliable study is available, conducted according to OECD guideline and GLP principles. A second study with reliability 4 presented no clear data on local effects and lacked exminations on organ weights and microscopy. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Study was performed according to OECD guidelines and GLP principles. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2faf3a9-1b7d-4bdb-84a1-122a2545c56a/documents/IUC5-b30da634-f5e7-4069-9af9-9741a229ca76_8f3453f8-9066-4ed2-a58a-86305e499506.html,,,,,, Tetramethylammonium hydroxide,75-59-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2faf3a9-1b7d-4bdb-84a1-122a2545c56a/documents/IUC5-b30da634-f5e7-4069-9af9-9741a229ca76_8f3453f8-9066-4ed2-a58a-86305e499506.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,5 mg/kg bw/day,,rat Tetramethylammonium hydroxide,75-59-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2faf3a9-1b7d-4bdb-84a1-122a2545c56a/documents/IUC5-b30da634-f5e7-4069-9af9-9741a229ca76_8f3453f8-9066-4ed2-a58a-86305e499506.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,10 mg/kg bw/day,,rat Tetramethylammonium hydroxide,75-59-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2faf3a9-1b7d-4bdb-84a1-122a2545c56a/documents/IUC5-b30da634-f5e7-4069-9af9-9741a229ca76_8f3453f8-9066-4ed2-a58a-86305e499506.html,Repeated dose toxicity – local effects,dermal,NOAEL,18.75 ,adverse effect observed, Tetramethylammonium hydroxide,75-59-2,"Oral toxicity: Four studies are available, resulting in the following LD50's for the pure substance, weight-of-evidence (studies with 25% solution):MB2005_1: 12.5 < LD50 < 125 mg/kg bwMB2005_2: LD50 = 43.5 mg/kg bwJSR2004: 12.5 < LD50 < 75 mg/kg bwSupporting study (studies with 2.5% solution):JSR2005: 7.5 < LD50 < 50 mg/kg bwDermal toxicity: Four studies are available, resulting in the following LD50's for the pure substance, weight-of-evidence (studies with 25% solution):MLI 2005: 12.5 < LD50 < 50 mg/kg bwAventis 2001: LD50 = 112 mg/kg bwJSR 2004: 50 < LD50 < 500 mg/kg bwSupporting study (studies with 2.5% solution):JSR 2005: 25 < LD50 < 50 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2faf3a9-1b7d-4bdb-84a1-122a2545c56a/documents/IUC5-6e051dd5-ad18-4985-b4a1-b8b499200bcb_8f3453f8-9066-4ed2-a58a-86305e499506.html,,,,,, Tetramethylammonium hydroxide,75-59-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2faf3a9-1b7d-4bdb-84a1-122a2545c56a/documents/IUC5-6e051dd5-ad18-4985-b4a1-b8b499200bcb_8f3453f8-9066-4ed2-a58a-86305e499506.html,,oral,LD50,12.5 mg/kg bw,adverse effect observed, Tetramethylammonium hydroxide,75-59-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2faf3a9-1b7d-4bdb-84a1-122a2545c56a/documents/IUC5-6e051dd5-ad18-4985-b4a1-b8b499200bcb_8f3453f8-9066-4ed2-a58a-86305e499506.html,,dermal,LD50,12.5 mg/kg bw,adverse effect observed, Tetramethylenediamine,110-60-1,"ORALMale and female rats were fed diets containing 0, 200, 2000 or 5000 ppm putrescine. Diets and tap-water were given ad libitum for a period of 5-6 weeks. Decreased body weights associated with diminished food intake were seen in the high dose group.The no-observed-adverse-effect level (NOAEL) of Diaminobutate was 2000 ppm (180 mg/kg body weight/day)In a 90 days study, male and female SD rats were fed with stanyl (tetramethyelediamine adipate salt) up to 3000 ppm. No rats died and clinical signs in treated rats were comparable to controls. Statistically- significant differences in organ weights were seen without associated gross or histological pathology and without dose response relationship. The authors set the NOAEL at the highest dose, which corresponds to 263 mg/kg bw/day male and female combined. Adjusting this value for the MW of tetramethylenediamine, the NOAEL of tetramethylenediamine is 107 mg/kg bw/day.INHALATIONIn an inhalation study Sprague-Dawley rats were exposed to 1,4-diaminobutane for 4 weeks at dose levels up to 270 mg/m3. The only treatment related effect observed was a low grade irritation primarily in the anterior nasal cavity of high and intermediate dose group animals only. In conclusion, in the absence of any in vivo treatment-related changes and the lack of any organ or tissue changes to suggest systemic toxicity or local irritation, the low dose level of 11 mg/m3 is considered to be the no effect level. This NOEL is supported by 2 inhalation studies (13 weeks) with hexamethylenedinamine study in Sprague-Dawley rats, reporting NOEL's of 12.8 mg/m3 and 10 mg/m3, and a subacute inhalation study (6 weeks) with ethylendiammine in Rats, with NOAEL of 148 mg/m3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8d8c479-e7af-45a3-b8ce-3cfa617ead2a/documents/4f55bfb6-1269-4f0f-8662-89572ba301c2_c3faed2b-57a5-4979-a4f4-9647c4972dd9.html,,,,,, Tetramethylenediamine,110-60-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8d8c479-e7af-45a3-b8ce-3cfa617ead2a/documents/4f55bfb6-1269-4f0f-8662-89572ba301c2_c3faed2b-57a5-4979-a4f4-9647c4972dd9.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,11 mg/m3,,rat Tetramethylenediamine,110-60-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8d8c479-e7af-45a3-b8ce-3cfa617ead2a/documents/4f55bfb6-1269-4f0f-8662-89572ba301c2_c3faed2b-57a5-4979-a4f4-9647c4972dd9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,107 mg/kg bw/day,,rat Tetramethylenediamine,110-60-1,"DAB: LD50 (oral) = 749 mg/kw bwDAB: LD50 (dermal) = 825 mg/kg bwDAB: LC50 (rat; inhalation) = 1,131 mg/l ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8d8c479-e7af-45a3-b8ce-3cfa617ead2a/documents/5bc16227-7109-406f-a1ae-bc0513b38baa_c3faed2b-57a5-4979-a4f4-9647c4972dd9.html,,,,,, Tetramethylenediamine,110-60-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8d8c479-e7af-45a3-b8ce-3cfa617ead2a/documents/5bc16227-7109-406f-a1ae-bc0513b38baa_c3faed2b-57a5-4979-a4f4-9647c4972dd9.html,,oral,LD50,749 mg/kg bw,, Tetramethylenediamine,110-60-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8d8c479-e7af-45a3-b8ce-3cfa617ead2a/documents/5bc16227-7109-406f-a1ae-bc0513b38baa_c3faed2b-57a5-4979-a4f4-9647c4972dd9.html,,dermal,LD50,825 mg/kg bw,, Tetramethylenediamine,110-60-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8d8c479-e7af-45a3-b8ce-3cfa617ead2a/documents/5bc16227-7109-406f-a1ae-bc0513b38baa_c3faed2b-57a5-4979-a4f4-9647c4972dd9.html,,inhalation,LC50,"1,131 mg/m3",, Tetramethylsilane,75-76-3," A combined repeat dose inhalation toxicity study and reproductive/developmental toxicity screening study was carried out for tetramethylsilane (CAS No. 75 -76 -3, EC No. 200-899 -1) according to OECD Test Guideline 422 and in compliance with GLP (Dow Corning Corporation, 2005, reliability score 1). There were no adverse effects on general systemic, reproductive or developmental endpoints at the highest dose tested, 5000 ppm (ca. 18,000 mg/m3). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e2a6dd5-679b-4dac-82bc-2ce4a692f7cf/documents/1301283f-8cbb-41ec-b824-199a0ccc6f9e_86f5cf9d-2340-43dd-9536-532719f7ab03.html,,,,,, Tetramethylsilane,75-76-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4e2a6dd5-679b-4dac-82bc-2ce4a692f7cf/documents/1301283f-8cbb-41ec-b824-199a0ccc6f9e_86f5cf9d-2340-43dd-9536-532719f7ab03.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"18,000 mg/m3",,rat Tetramethylsilane,75-76-3," In the key acute oral toxicity study for tetramethylsilane (CAS No. 75 -76 -3, EC No. 200-899 -1) conducted according to OECD 401 and in compliance with GLP, the LD50 for male and female rats was >2000 mg/kg (Hüls, 1998, reliability score 1). The following clinical symptoms were observed 30 minutes to six hours after treatment: abnormal gait, squatting position, sedation, paddling movements, piloerection, diarrhoea and diuresis. From day one until the end of the study (day 14) no other clinical signs were observed. No abnormalities were detected at necropsy. In the key acute inhalation study, conducted in accordance with OECD 403 and in compliance with GLP, the LC50 was determined to be >21.3 mg/l in male and female rats (TNO Nutrition and Food Research Institute, 1998, reliability score 1). There were no mortalities or clinical signs of toxicity. Findings at necropsy consisted of abnormalities in the lungs, intestines and testes. Abnormalities of the lungs consisted of petechiae and/or hyalin spots or areas on one or more lobes in most animals. Pale discolouration of the lungs was seen in one male animal. In the key acute dermal toxicity study, conducted according to OECD 402 and in compliance with GLP, the LD50 for male and female rats was determined to be >2000 mg/kg (Hüls, 1998, reliability score 1). There were no clinical signs, signs of local irritation or abnormalities at necropsy. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e2a6dd5-679b-4dac-82bc-2ce4a692f7cf/documents/8b07c1b5-bbcb-42b3-b3da-023777b9eeeb_86f5cf9d-2340-43dd-9536-532719f7ab03.html,,,,,, Tetramethylsilane,75-76-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e2a6dd5-679b-4dac-82bc-2ce4a692f7cf/documents/8b07c1b5-bbcb-42b3-b3da-023777b9eeeb_86f5cf9d-2340-43dd-9536-532719f7ab03.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Tetramethylsilane,75-76-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e2a6dd5-679b-4dac-82bc-2ce4a692f7cf/documents/8b07c1b5-bbcb-42b3-b3da-023777b9eeeb_86f5cf9d-2340-43dd-9536-532719f7ab03.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Tetramethylsilane,75-76-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4e2a6dd5-679b-4dac-82bc-2ce4a692f7cf/documents/8b07c1b5-bbcb-42b3-b3da-023777b9eeeb_86f5cf9d-2340-43dd-9536-532719f7ab03.html,,inhalation,LC50,"> 21,300 mg/m3",no adverse effect observed, "Tetra-n-butyl titanate, polymer with water",162303-51-7,"Repeated toxicity testing was considered unnecessary since the target substance undergoes immediate disintegration and there are sufficient data on cleavage product for the oral and inhalation exposure routes. The intrinsic properties of this substance after repeated administration are related to the most hazardous degradation product, n-butanol. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86c50473-a073-42e8-ae14-a7ad020c4f57/documents/d23e6a7b-4da3-4c9a-a67b-33ea67f0d03a_72d8610d-2fb0-4fa3-beee-034744a6d729.html,,,,,, "Tetra-n-butyl titanate, polymer with water",162303-51-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86c50473-a073-42e8-ae14-a7ad020c4f57/documents/d23e6a7b-4da3-4c9a-a67b-33ea67f0d03a_72d8610d-2fb0-4fa3-beee-034744a6d729.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "Tetra-n-butyl titanate, polymer with water",162303-51-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86c50473-a073-42e8-ae14-a7ad020c4f57/documents/d23e6a7b-4da3-4c9a-a67b-33ea67f0d03a_72d8610d-2fb0-4fa3-beee-034744a6d729.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,520 mg/m3",,rat "Tetra-n-butyl titanate, polymer with water",162303-51-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/86c50473-a073-42e8-ae14-a7ad020c4f57/documents/d23e6a7b-4da3-4c9a-a67b-33ea67f0d03a_72d8610d-2fb0-4fa3-beee-034744a6d729.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"1,520 mg/m3",no adverse effect observed,rat "Tetra-n-butyl titanate, polymer with water",162303-51-7,"Oral:There is reliable, guideline compliant study available for tetra-n-butyl titanate, polymer with water. The oral LD50 (rat; female) is greater than 2 000 mg/kg bwInhalation:There is no reliable data available for acute inhalation toxicity for the target substance.The LC50 (rat; male) for n-butanol, the degradation product, is > 20 100 mg/m3Dermal:There is no valid data available for acute oral toxicity for the target substance.The dermal LD50 (rat; male, female) for the n-butanol, the degradation product, is 5 300 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86c50473-a073-42e8-ae14-a7ad020c4f57/documents/bf57340c-78f5-4b34-8a76-f2fa2bf317fd_72d8610d-2fb0-4fa3-beee-034744a6d729.html,,,,,, "Tetra-n-butyl titanate, polymer with water",162303-51-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86c50473-a073-42e8-ae14-a7ad020c4f57/documents/bf57340c-78f5-4b34-8a76-f2fa2bf317fd_72d8610d-2fb0-4fa3-beee-034744a6d729.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetra-n-butyl titanate, polymer with water",162303-51-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86c50473-a073-42e8-ae14-a7ad020c4f57/documents/bf57340c-78f5-4b34-8a76-f2fa2bf317fd_72d8610d-2fb0-4fa3-beee-034744a6d729.html,,dermal,LD50,"5,300 mg/kg bw",no adverse effect observed, "Tetra-n-butyl titanate, polymer with water",162303-51-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/86c50473-a073-42e8-ae14-a7ad020c4f57/documents/bf57340c-78f5-4b34-8a76-f2fa2bf317fd_72d8610d-2fb0-4fa3-beee-034744a6d729.html,,inhalation,LC50,"20,100 mg/m3",no adverse effect observed, Tetraoctylammonium bromide,14866-33-2," Acute oral toxicity LD50 was estimated to be 2294.15mg/kg bw, when female wistar rats were exposed with Tetraoctylammonium Bromide (14866-33-2) orally. Acute dermal toxicity LD50 was estimated to be 4805.16mg/kg bw.When male and female New Zealand White rabbits were exposed with Tetraoctylammonium Bromide (14866-33-2) by dermal application. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c25f17be-166b-4b7c-9f05-e1ab272d3298/documents/680ff85a-bb48-4633-85ee-8271d5ed4abf_47110ffe-4160-46e6-9a50-2c29b31ef50e.html,,,,,, Tetraoctylammonium bromide,14866-33-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c25f17be-166b-4b7c-9f05-e1ab272d3298/documents/680ff85a-bb48-4633-85ee-8271d5ed4abf_47110ffe-4160-46e6-9a50-2c29b31ef50e.html,,oral,LD50,"2,294.15 mg/kg bw",no adverse effect observed, Tetraoctylammonium bromide,14866-33-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c25f17be-166b-4b7c-9f05-e1ab272d3298/documents/680ff85a-bb48-4633-85ee-8271d5ed4abf_47110ffe-4160-46e6-9a50-2c29b31ef50e.html,,dermal,LD50,"4,805.16 mg/kg bw",no adverse effect observed, Tetraoctyltin,3590-84-9,"A guideline 28-day subacute dietary study conducted in Wistar rats was identified as the key study.Based on the observed effects in the high-dose animals, decrease in thymus weight (male and female animals) and microscopic findings in the thymus (female animals), the No Observed Adverse Effect Level (NOAEL) for general toxicity is established at the mid-dose level (1500 mg/kg diet which is equivalent to 86-99 mg/kg body weight/day for the male animals and to 80-141 mg/kg body weight/day for the female animals. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8449963-6a44-4441-bd99-65e0d1111892/documents/IUC5-ece677ac-6889-4a1e-a396-bd8d9769cd41_2a680b18-e2d0-42f1-8495-df10ec728ea8.html,,,,,, Tetraoctyltin,3590-84-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8449963-6a44-4441-bd99-65e0d1111892/documents/IUC5-ece677ac-6889-4a1e-a396-bd8d9769cd41_2a680b18-e2d0-42f1-8495-df10ec728ea8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat Tetraoctyltin,3590-84-9,"The following information is available for the acute oral toxicity endpoint:Prinsen, (2003). Tetraoctylstannane [CAS # 3590-84-9]: acute oral toxicty study with rats, Testing laboratory: TNO Nutrition and Food research. Report no.: V 4410/18. Owner company: Organotin Environmental Programme (ORTEP) Association Stabilizer Task Force.Kopp, Gunzel, Richter (1973). Systemische Vertraglichkeitsprufung (DL50) nach einmaliger Verabreichung von ZK. 44.682 and Ratten. Testing laboratory: Schering AG. Report no.: Prot. Nr. 3532. Report date: 1973-04-19.Prinsen, (2003), is presented as the key information as the reliability rating for this study is 1, according to the criteria of Klimisch, 1997, and so is the most reliable study. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8449963-6a44-4441-bd99-65e0d1111892/documents/IUC5-a02cd21a-6b1e-4d07-a951-e1ab9dd39d11_2a680b18-e2d0-42f1-8495-df10ec728ea8.html,,,,,, Tetraoctyltin,3590-84-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8449963-6a44-4441-bd99-65e0d1111892/documents/IUC5-a02cd21a-6b1e-4d07-a951-e1ab9dd39d11_2a680b18-e2d0-42f1-8495-df10ec728ea8.html,,oral,LD50,"2,000 mg/kg bw",, Tetraphosphorus trisulphide,1314-85-8, LOAEL Tetraphosphorus trisulphide (repeated oral toxicity pregnant female rats treated for 10 days post coitum) = 50 mg/kg bw/day and estimated NOAEL (repeated oral toxicity 28 days rat)= 1 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/826337e9-f1d0-4918-949b-1341b494ca3c/documents/7991b4ac-a33a-40c8-adde-f20ffce5d1c4_7d295d18-1d0a-48ef-ab41-ea126d57c6db.html,,,,,, Tetraphosphorus trisulphide,1314-85-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/826337e9-f1d0-4918-949b-1341b494ca3c/documents/7991b4ac-a33a-40c8-adde-f20ffce5d1c4_7d295d18-1d0a-48ef-ab41-ea126d57c6db.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,1 mg/kg bw/day,,rat Tetraphosphorus trisulphide,1314-85-8, Extrapolated LD50 oral rat between 50 and 300 mg/kg bw/day. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/826337e9-f1d0-4918-949b-1341b494ca3c/documents/9d81bd11-2d12-474a-afc7-b96a8304bb15_7d295d18-1d0a-48ef-ab41-ea126d57c6db.html,,,,,, Tetrapotassium hexacyanoferrate,13943-58-3," In a long term (two year) repeated dose toxicity study with rats, supplemented with two interim studies (49-51 weeks and 80-82 weeks respectively), the NOAEL was determined to be ≥ 630 and ≥ 450 mg/kg bw/day for females and males, respectively, based on the absence of effects seen at the highest concentration of the read across substance sodium ferrocyanide (5000 ppm in the food). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ac79499-4567-4557-8f35-da2a1f33a77b/documents/065f43e5-a622-4d38-a830-faab8348721e_2f2ecbd8-b222-4b0f-8c12-9241274543a0.html,,,,,, Tetrapotassium hexacyanoferrate,13943-58-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6ac79499-4567-4557-8f35-da2a1f33a77b/documents/065f43e5-a622-4d38-a830-faab8348721e_2f2ecbd8-b222-4b0f-8c12-9241274543a0.html,Chronic toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat Tetrapotassium hexacyanoferrate,13943-58-3," Acute oral and dermal toxicity studies are available, performed similar to or according to OECD test guidelines respectively for the target's analogue sodium ferrocyanide. The LD50 values are > 2000 mg/kg bw for both studies. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ac79499-4567-4557-8f35-da2a1f33a77b/documents/0d1a8b28-c894-4eb3-9eb9-1294e1b62db7_2f2ecbd8-b222-4b0f-8c12-9241274543a0.html,,,,,, Tetrapotassium hexacyanoferrate,13943-58-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ac79499-4567-4557-8f35-da2a1f33a77b/documents/0d1a8b28-c894-4eb3-9eb9-1294e1b62db7_2f2ecbd8-b222-4b0f-8c12-9241274543a0.html,,oral,LD50,"5,110 mg/kg bw",no adverse effect observed, Tetrapotassium hexacyanoferrate,13943-58-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6ac79499-4567-4557-8f35-da2a1f33a77b/documents/0d1a8b28-c894-4eb3-9eb9-1294e1b62db7_2f2ecbd8-b222-4b0f-8c12-9241274543a0.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetrapropyl orthosilicate,682-01-9,"There are no repeated dose toxicity studies, therefore good quality data on the structurally-related substance, tetraethyl orthosilicate have been read-across for the oral and inhalation routes. In a good quality OECD 422 study (CIT, 2005) conducted to GLP, the parental NOAEL for tetraethylorthosilicate in rats was 50 mg/kg bw/day for the females and 10 mg/kg bw/day for the males, based on adverse effects on the kidneys (tubular nephropathy). In a repeated inhalation study which was similar to OECD 412 (no information on GLP status) the LOAEC for tetraethoxysilane was 50 ppm (426 mg/m3 based on a molecular weight of 208.33) in mice, based on haematological changes (lower haemoglobin, red blood cell count and haematocrit values in exposed mice than in non-exposed mice, but not there was no dose-response). Effects on the kidney (tubulo-interstitial nephritis) were observed at 100 ppm when exposure was over two or four weeks. There were also signs of irritation in the nasal mucosa. (Omae et al., 1995). There are no dermal data. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c54389f-332d-4aa7-b8a8-1ee53d7e9e87/documents/IUC5-d511dde9-76cf-42df-a7e5-e05e1105709e_b83e7f13-146e-4bcd-9aaa-c1e2843ebba0.html,,,,,, Tetrapropyl orthosilicate,682-01-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c54389f-332d-4aa7-b8a8-1ee53d7e9e87/documents/IUC5-d511dde9-76cf-42df-a7e5-e05e1105709e_b83e7f13-146e-4bcd-9aaa-c1e2843ebba0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Tetrapropyl orthosilicate,682-01-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c54389f-332d-4aa7-b8a8-1ee53d7e9e87/documents/IUC5-d511dde9-76cf-42df-a7e5-e05e1105709e_b83e7f13-146e-4bcd-9aaa-c1e2843ebba0.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,426 mg/m3,,mouse Tetrapropyl orthosilicate,682-01-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c54389f-332d-4aa7-b8a8-1ee53d7e9e87/documents/IUC5-d511dde9-76cf-42df-a7e5-e05e1105709e_b83e7f13-146e-4bcd-9aaa-c1e2843ebba0.html,Repeated dose toxicity – local effects,inhalation,LOAEC,426 mg/m3,adverse effect observed,mouse Tetrapropyl orthosilicate,682-01-9,"In an acute oral toxicity study conducted to OECD 423 and to GLP (LPT, 2002a) the oral LD50 value for tetrapropyl orthosilicate in CD rats was established to exceed 2000 mg/kg bw. There were no clinical signs of toxicity, affects on body weights or macroscopic findings. There are no acute inhalation data on tetrapropyl orthosilicate therefore good quality data have been read-across from the structurally-related tetraethyl orthosilicate. The LC50 value of 10.0 mg/l tetraethyl orthosilicate (aerosol) in male rats and >16.8 mg/l in female rats was determined in a reliable study (Hoechst AG, 1991) conducted according to an appropriate test protocol, and in compliance with GLP.There are no acute dermal data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c54389f-332d-4aa7-b8a8-1ee53d7e9e87/documents/IUC5-72e9f94c-ac93-4ba6-8eaa-9931cf8c3b8f_b83e7f13-146e-4bcd-9aaa-c1e2843ebba0.html,,,,,, Tetrapropyl orthosilicate,682-01-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c54389f-332d-4aa7-b8a8-1ee53d7e9e87/documents/IUC5-72e9f94c-ac93-4ba6-8eaa-9931cf8c3b8f_b83e7f13-146e-4bcd-9aaa-c1e2843ebba0.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetrapropyl orthosilicate,682-01-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c54389f-332d-4aa7-b8a8-1ee53d7e9e87/documents/IUC5-72e9f94c-ac93-4ba6-8eaa-9931cf8c3b8f_b83e7f13-146e-4bcd-9aaa-c1e2843ebba0.html,,inhalation,LC50,"10,000 mg/m3",no adverse effect observed, Tetrapropylammonium bromide,1941-30-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available oral toxicity test is conducted according to OECD 401. The study was conducted before GLP guidelines were in place. It is reliable without restrictions (score 1). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f374b6b2-2a4e-47f9-9746-ffb9d4152dc7/documents/IUC5-278ef17d-9cee-473f-8c7f-77736e6420df_235f104f-e166-4a97-aa1d-6d1390e56d99.html,,,,,, Tetrapropylammonium bromide,1941-30-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f374b6b2-2a4e-47f9-9746-ffb9d4152dc7/documents/IUC5-278ef17d-9cee-473f-8c7f-77736e6420df_235f104f-e166-4a97-aa1d-6d1390e56d99.html,,oral,LD50,"3,500 mg/kg bw",no adverse effect observed, "Tetrasodium [29H,31H-phthalocyaninetetrasulphonato(6-)-N29,N30,N31,N32]cuprate(4-)",27360-85-6,"ACUTE ORALLD50 > 2000 mg/kg bw (female rat); OECD 423, EU Method B.1. tris, EPA OPPTS 870.1100, EPA 712-C-98-190; Mátyás A. (2015) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8a8cf5d-1223-4b9b-a8c8-5fae1b81e6a2/documents/IUC5-fa4611b2-eea4-4d2b-afd4-ebc9ba0b5119_528ddaef-8bce-4b0b-b9f3-bf64bb10e789.html,,,,,, "Tetrasodium [29H,31H-phthalocyaninetetrasulphonato(6-)-N29,N30,N31,N32]cuprate(4-)",27360-85-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8a8cf5d-1223-4b9b-a8c8-5fae1b81e6a2/documents/IUC5-fa4611b2-eea4-4d2b-afd4-ebc9ba0b5119_528ddaef-8bce-4b0b-b9f3-bf64bb10e789.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetrasodium [3-[(3-chloro-2-hydroxy-5-sulphophenyl)azo]-5-[[4-chloro-6-(3-sulphoanilino)-1,3,5-triazin-2-yl]amino]-4-hydroxynaphthalene-2,7-disulphonato(6-)]cuprate(4-)",70880-03-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e93b285f-baf3-4471-aea4-d8746c3c7656/documents/a9b0fe0d-25ba-4888-b7a6-ac8efdc38db7_c7f7712a-b78f-4bda-9aaf-006d2eade869.html,,oral,LD50,"5,916 mg/kg bw",adverse effect observed, "Tetrasodium [3-[(3-chloro-2-hydroxy-5-sulphophenyl)azo]-5-[[4-chloro-6-(3-sulphoanilino)-1,3,5-triazin-2-yl]amino]-4-hydroxynaphthalene-2,7-disulphonato(6-)]cuprate(4-)",70880-03-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e93b285f-baf3-4471-aea4-d8746c3c7656/documents/a9b0fe0d-25ba-4888-b7a6-ac8efdc38db7_c7f7712a-b78f-4bda-9aaf-006d2eade869.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Tetrasodium [μ-[[3,3'-[(3,3'-dihydroxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicuprate(4-)",28407-37-6," Repeated dose toxicity: Oral 14 days repeated dose toxicity study was conducted to determine the toxic nature of C.I. Direct blue 218. The study was performed using male and female B6C3F1 mice and dosing the test chemical in feed at dose levels of0 , 1,000, 3000, 7000, 15000, or 30000 ppm (0, 200, 600, 1400, 3000 or 6000 mg/Kg/day). The animals were observed for clinical signs, body weight, changes in body weight and food consumption and were subjected to gross pathology and histopathology. No animals died during the study period.Blue discoloration of the feces was observed in all exposed groups of male and female mice. Male and female mice of the 30000 ppm (6000 mg/Kg/day) appeared emaciated and hyperactive during the last week of the study. Male and female mice exposed to 30,000 ppm (6000 mg/Kg/day) lost weight. The final mean body weights of other exposed groups were similar to those of the controls. Feed consumption by exposed groups was similar to that by controls, except for the last week of the study, when the apparent amount of feed consumed by the 15,000 and 30,000 ppm groups was greater than that consumed by the controls. This increased feed consumption was related to increased feed spillage in these exposure groups. In male mice that received 15,000 ppm (3000 mg/Kg/day), the absolute and relative liver weights were significantly greater than those of the controls, and in males exposed to 30,000 ppm (6000 mg/Kg/day) and females exposed to 15,000 and 30,000 ppm (3000 and 6000 mg/Kg/day) the relative liver weights were significantly greater than those of controls. In the 30,000 ppm groups (6000 mg/Kg/day), there were some significantly lower absolute organ weights which were attributed to the lower body weights. The relative heart weight of 30,000 ppm (6000 mg/Kg/day) females and the relative thymus weights of 30,000 ppm (6000 mg/Kg/day) males and females were significantly lower than those of the controls. At necropsy, the skin and gastrointestinal tracts of exposed male and female mice had blue discoloration. Based on the observations made, the No observed adverse effect level (NOAEL) for C.I. Direct blue 218 is considered to be 3000 mg/Kg/day for males and females B6C3F1 mice. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8f95b43-8d92-4614-9f04-d28c2a5f2bcc/documents/41752b03-966e-45b5-9c69-df7b35432a42_b428ef61-7fa6-4057-b06c-cf5923c0e0bf.html,,,,,, "Tetrasodium [μ-[[3,3'-[(3,3'-dihydroxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicuprate(4-)",28407-37-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e8f95b43-8d92-4614-9f04-d28c2a5f2bcc/documents/41752b03-966e-45b5-9c69-df7b35432a42_b428ef61-7fa6-4057-b06c-cf5923c0e0bf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"3,000 mg/kg bw/day",,mouse "Tetrasodium [μ-[[3,3'-[(3,3'-dihydroxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicuprate(4-)",28407-37-6," Acute Oral Toxicity:            In Acute oral toxicity ,LD50 value for target substance Copper,[tetrahydrogen-3,3'-[(3,3'-dihydroxy-4,4'-biphenylylene)bis(azo)]bis[5-amino-4-hydroxy-2,7-naphthalenedisulfonato](4-)]di-,tetrasodium salt (7CI) (28407-37-6) was considered to be 3290 mg/kg bw;<5000 mg/kg bw;4700 mg/kg bw and approximately 4000 mg/kg bw in rats. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Copper,[tetrahydrogen-3,3'-[(3,3'-dihydroxy-4,4'-biphenylylene)bis(azo)]bis[5-amino-4-hydroxy-2,7-naphthalenedisulfonato](4-)]di-,tetrasodium salt (7CI) (28407-37-6) cannot be classified for acute oral toxicity. Acute Inhalation Toxicity:           In Acute inhalation toxicity ,LC50 value for target substance Copper,[tetrahydrogen-3,3'-[(3,3'-dihydroxy-4,4'-biphenylylene)bis(azo)]bis[5-amino-4-hydroxy-2,7-naphthalenedisulfonato](4-)]di-,tetrasodium salt (7CI) (28407-37-6) was considered to be 11.71 mg/l and 182 mg/l in rats. All these studies concluded that the LC50 value is greater than 5 mg/L air. Thus, comparing this value with the criteria of CLP regulation, Copper,[tetrahydrogen-3,3'-[(3,3'-dihydroxy-4,4'-biphenylylene)bis(azo)]bis[5-amino-4-hydroxy-2,7-naphthalenedisulfonato](4-)]di-,tetrasodium salt (7CI) (28407-37-6) cannot be classified for acute inhalation toxicity. Acute Dermal Toxicity: In Acute dermal toxicity, LD50 value for target substance Copper,[tetrahydrogen-3,3'-[(3,3'-dihydroxy-4,4'-biphenylylene)bis(azo)]bis[5-amino-4-hydroxy-2,7-naphthalenedisulfonato](4-)]di-,tetrasodium salt (7CI) (28407-37-6) was considered to be >2000 mg/kg bw;>8000 mg/kg bw and >2000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Copper,[tetrahydrogen-3,3'-[(3,3'-dihydroxy-4,4'-biphenylylene)bis(azo)]bis[5-amino-4-hydroxy-2,7-naphthalenedisulfonato](4-)]di-,tetrasodium salt (7CI) (28407-37-6) cannot be classified for acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8f95b43-8d92-4614-9f04-d28c2a5f2bcc/documents/208fd061-2dac-490e-8462-7532402ec4da_b428ef61-7fa6-4057-b06c-cf5923c0e0bf.html,,,,,, "Tetrasodium [μ-[[3,3'-[(3,3'-dihydroxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicuprate(4-)",28407-37-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8f95b43-8d92-4614-9f04-d28c2a5f2bcc/documents/208fd061-2dac-490e-8462-7532402ec4da_b428ef61-7fa6-4057-b06c-cf5923c0e0bf.html,,oral,LD50,"3,290 mg/kg bw",no adverse effect observed, "Tetrasodium [μ-[[3,3'-[(3,3'-dihydroxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicuprate(4-)",28407-37-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8f95b43-8d92-4614-9f04-d28c2a5f2bcc/documents/208fd061-2dac-490e-8462-7532402ec4da_b428ef61-7fa6-4057-b06c-cf5923c0e0bf.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetrasodium [μ-[[3,3'-[(3,3'-dihydroxy[1,1'-biphenyl]-4,4'-diyl)bis(azo)]bis[5-amino-4-hydroxynaphthalene-2,7-disulphonato]](8-)]]dicuprate(4-)",28407-37-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e8f95b43-8d92-4614-9f04-d28c2a5f2bcc/documents/208fd061-2dac-490e-8462-7532402ec4da_b428ef61-7fa6-4057-b06c-cf5923c0e0bf.html,,inhalation,LC50,"11,710 mg/m3",no adverse effect observed, "Tetrasodium [μ-[[3,3'-[azoxybis[(2-hydroxy-p-phenylene)azo]]bis[4-hydroxy-6-(3-sulphoanilino)naphthalene-2-sulphonato]](8-)]]dicuprate(4-)",31765-95-4,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24b38437-4364-4ce6-ace4-e37d8724c342/documents/52644803-e50b-4fca-a803-0b51b41e0d85_f3c89944-ff72-4a71-8b06-27679e2b5506.html,,,,,, "Tetrasodium [μ-[[3,3'-[azoxybis[(2-hydroxy-p-phenylene)azo]]bis[4-hydroxy-6-(3-sulphoanilino)naphthalene-2-sulphonato]](8-)]]dicuprate(4-)",31765-95-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24b38437-4364-4ce6-ace4-e37d8724c342/documents/52644803-e50b-4fca-a803-0b51b41e0d85_f3c89944-ff72-4a71-8b06-27679e2b5506.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Tetrasodium [μ-[3-[[2-amino-5-hydroxy-6-[(2-hydroxy-5-nitro-3-sulphophenyl)azo]-7-sulpho-1-naphthyl]azo]-2-hydroxy-5-sulphobenzoato(8-)]]dichromate(4-),72252-58-5," The purpose of this repeated dose toxicity study was to evaluate the systemic toxicity profile of the test item in wistar rats when administered orally by gavage for 28 consecutive days and also to assess the reversibilityof any effects following 14days recovery period. This study was also intended to provide the information on major toxic effects, target organs and an estimation of a No Observed Adverse Effect Level (NOAEL). Salient findings: Clinical Signs, Mortalities and Ophthalmological Examination: No clinical signs or mortalities or ocular abnormalities were observed throughout the experimental period. Neurological Findings: No treatment-related neurological abnormalities /dysfunctions were observed at all the doses tested. Body Weights: The mean body weights were unaffected by the treatment in both the sexes at all the tested doses in both sexes.  Food Consumption: There were no significant differences observed in the food consumption at all the doses tested in both sexes throughout the experimental period.  Haematology, Coagulation, Clinical chemistry and Urine Parameters: No test item-related changes were observed in the haematological, coagulation, clinical chemistry and urine parameters.  Organ Weights: The terminal fasting body weights, organ weights and their ratios were not affected by test item administration. Gross and Histopathology: At 100 mg/kg/day, grossly, green colored intestinal content was observed in both sexes at the end of treatment period. Microscopically single incidence of pigmented macrophages in lungs was observed in male rats. At 300 mg/kg/day, gray discoloration of kidneys, green discoloration of mandibular lymph nodes and mesenteric lymph node and green colored intestinal content were observed in both sexes. Microscopically pigmented macrophages in lungs in females, pigment deposits in mandibular lymph nodes in both sexes and pigment deposits in mesenteric lymph nodes in males were observed. At 1000 mg/kg/day, grossly, gray/green discoloration of kidneys and liver lobes in both sexes, green discoloration of mandibular lymph nodes and mesenteric lymph node in both sexes, multifocal green discoloration of glandular mucosa of stomach in both sexes, gray discoloration of testes in males, focal green discoloration of lungs in females and green color intestinal content in both sexes were observed at the end of treatment period. These gross changes persisted in males and/or females except green colored intestinal content at the end of recovery period. Microscopically dark deposits in lamina propria of jejunum in both sexes, pigment macrophages in lungs in females, dark deposits in mandibular lymph nodes and mesenteric lymph nodes in both sexes were observed at the end of treatment period. Dark deposits in lamina propria of jejunum (males and females), pigment macrophages in lungs (males) and dark deposits in mandibular and mesenteric lymph nodes (males and females) were also observed at the end of recovery period. All the above gross and microscopic changes (without any inflammatory response) observed in different groups were attributed to the physical appearance of test item and considered as test item-related non-adverse changes. The No Observed Adverse Effect Level (NOAEL) is considered to be 1000 mg/kg/day following oral gavage administration for 28 consecutive days to wistar rats under the test conditions and doses employed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7cafda52-4a7c-49bf-b70d-ee1d1c667a86/documents/6fa0aeba-d133-46e4-ac7d-7709d96d9cd5_5b34be47-1139-4a87-a744-47a310df7436.html,,,,,, Tetrasodium [μ-[3-[[2-amino-5-hydroxy-6-[(2-hydroxy-5-nitro-3-sulphophenyl)azo]-7-sulpho-1-naphthyl]azo]-2-hydroxy-5-sulphobenzoato(8-)]]dichromate(4-),72252-58-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7cafda52-4a7c-49bf-b70d-ee1d1c667a86/documents/6fa0aeba-d133-46e4-ac7d-7709d96d9cd5_5b34be47-1139-4a87-a744-47a310df7436.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tetrasodium [μ-[3-[[2-amino-5-hydroxy-6-[(2-hydroxy-5-nitro-3-sulphophenyl)azo]-7-sulpho-1-naphthyl]azo]-2-hydroxy-5-sulphobenzoato(8-)]]dichromate(4-),72252-58-5, The acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2500 mg/kg body weight. The acute dermal LD50of the test item is more than 2000 mg/kg body weight in male and female Wistar rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cafda52-4a7c-49bf-b70d-ee1d1c667a86/documents/af931302-07c5-4339-9be8-34d5001978c9_5b34be47-1139-4a87-a744-47a310df7436.html,,,,,, Tetrasodium [μ-[3-[[2-amino-5-hydroxy-6-[(2-hydroxy-5-nitro-3-sulphophenyl)azo]-7-sulpho-1-naphthyl]azo]-2-hydroxy-5-sulphobenzoato(8-)]]dichromate(4-),72252-58-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cafda52-4a7c-49bf-b70d-ee1d1c667a86/documents/af931302-07c5-4339-9be8-34d5001978c9_5b34be47-1139-4a87-a744-47a310df7436.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, Tetrasodium [μ-[3-[[2-amino-5-hydroxy-6-[(2-hydroxy-5-nitro-3-sulphophenyl)azo]-7-sulpho-1-naphthyl]azo]-2-hydroxy-5-sulphobenzoato(8-)]]dichromate(4-),72252-58-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7cafda52-4a7c-49bf-b70d-ee1d1c667a86/documents/af931302-07c5-4339-9be8-34d5001978c9_5b34be47-1139-4a87-a744-47a310df7436.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "tetrasodium 2-(4-fluoro-6-(methyl-(2-(sulfatoethylsulfonyl)ethyl)amino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(4-methyl-2-sulfonatophenylazo)naphthalene-1,7-disulfonate",243858-01-7,"Based on the appearance of reversible dose-dependent, slight acute topical irritations in the submucosa of the stomach in intermediate and high dose animals, and absence of any systemic effects, the NOAEL for systemic effects, the NOAEL for local effects and the NOEL were determined to be 1000, 62.5 and 62.5 mg/kg bw/day, respectively. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): High quality study ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/228905cd-eb42-4ca5-813b-13280a4d9b88/documents/IUC5-ba6a6bd9-a357-4093-b95f-aed0b0272e82_1e930208-7414-4758-af25-cab722f36bfc.html,,,,,, "tetrasodium 2-(4-fluoro-6-(methyl-(2-(sulfatoethylsulfonyl)ethyl)amino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(4-methyl-2-sulfonatophenylazo)naphthalene-1,7-disulfonate",243858-01-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/228905cd-eb42-4ca5-813b-13280a4d9b88/documents/IUC5-ba6a6bd9-a357-4093-b95f-aed0b0272e82_1e930208-7414-4758-af25-cab722f36bfc.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "tetrasodium 2-(4-fluoro-6-(methyl-(2-(sulfatoethylsulfonyl)ethyl)amino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(4-methyl-2-sulfonatophenylazo)naphthalene-1,7-disulfonate",243858-01-7,"The test substance is considered to be of low acute (oral and dermal) toxicity with LD50 values >2,000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/228905cd-eb42-4ca5-813b-13280a4d9b88/documents/IUC5-f3bc7589-c7e8-45cf-848f-4a2edebb460e_1e930208-7414-4758-af25-cab722f36bfc.html,,,,,, "tetrasodium 2-(4-fluoro-6-(methyl-(2-(sulfatoethylsulfonyl)ethyl)amino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(4-methyl-2-sulfonatophenylazo)naphthalene-1,7-disulfonate",243858-01-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/228905cd-eb42-4ca5-813b-13280a4d9b88/documents/IUC5-f3bc7589-c7e8-45cf-848f-4a2edebb460e_1e930208-7414-4758-af25-cab722f36bfc.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, "tetrasodium 2-(4-fluoro-6-(methyl-(2-(sulfatoethylsulfonyl)ethyl)amino)-1,3,5-triazin-2-ylamino)-5-hydroxy-6-(4-methyl-2-sulfonatophenylazo)naphthalene-1,7-disulfonate",243858-01-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/228905cd-eb42-4ca5-813b-13280a4d9b88/documents/IUC5-f3bc7589-c7e8-45cf-848f-4a2edebb460e_1e930208-7414-4758-af25-cab722f36bfc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetrasodium 2,2'-[1,4-phenylenebis[carbonylimino[2-acetamido-4,1-phenylene]azo]]bis[5-[(4-sulphonatophenyl)azo]benzenesulphonate]",70210-30-9," Repeated dose toxicity: Oral: Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for Tetrasodium 2,2'-[1,4-phenylenebis [carbonylimino [2-acetamido-4,1-phenylene]azo]] bis[5-[(4-sulphonatophenyl)azo] benzenesulphonate]. The study assumed the use of male and female rats in a 28 days toxicity study. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Level (NOAEL) for Tetrasodium 2,2'-[1,4-phenylenebis [carbonylimino [2-acetamido-4,1-phenylene]azo]] bis[5-[(4- sulphonatophenyl)azo] benzenesulphonate] is predicted to be 568.900024414 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/75d88290-72eb-4249-8a4e-e108168cece1/documents/15aaa837-c228-4018-8f6e-d824a0aa2e4e_81880b4c-cbfb-4bf0-b45d-cdd67290b6bb.html,,,,,, "Tetrasodium 2,2'-[1,4-phenylenebis[carbonylimino[2-acetamido-4,1-phenylene]azo]]bis[5-[(4-sulphonatophenyl)azo]benzenesulphonate]",70210-30-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/75d88290-72eb-4249-8a4e-e108168cece1/documents/15aaa837-c228-4018-8f6e-d824a0aa2e4e_81880b4c-cbfb-4bf0-b45d-cdd67290b6bb.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,568.9 mg/kg bw/day,,rat "Tetrasodium 2,2'-[1,4-phenylenebis[carbonylimino[2-acetamido-4,1-phenylene]azo]]bis[5-[(4-sulphonatophenyl)azo]benzenesulphonate]",70210-30-9," Acute Oral Toxicity:  In Acute oral toxicity, LD50 value was predicted based on OECD QSAR toolbox for target substance tetrasodium 2-[(E)-2-{2-acetamido-4-[4-({3-acetamido-4-[(E)-2-{2-sulfonato-4-[(E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl} diazen-1-yl]phenyl}carbamoyl)benzamido]phenyl}diazen-1-yl]-5-[(E)-2-(4-sulfonatophenyl)diazen-1-yl]benzene-1-sulfonate (70210-30-9) was estimated to be 3842.59 mg/kg bw, and for different studies available on the structurally similar read across substance.LD50 value was considered to be greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, tetrasodium 2-[(E)-2-{2-acetamido-4-[4-({3-acetamido-4-[(E)-2-{2-sulfonato-4-[(E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl} diazen-1-yl]phenyl}carbamoyl)benzamido]phenyl}diazen-1-yl]-5-[(E)-2-(4-sulfonatophenyl)diazen-1-yl]benzene-1-sulfonate (70210-30-9)cannot be classified for acute oral toxicity.     Acute Dermal Toxicity: In Acute dermal toxicity, LD50 value was predicted based on OECD QSAR toolbox for target substance tetrasodium 2-[(E)-2-{2-acetamido-4-[4-({3-acetamido-4-[(E)-2-{2-sulfonato-4-[(E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl} diazen-1-yl]phenyl}carbamoyl)benzamido]phenyl}diazen-1-yl]-5-[(E)-2-(4-sulfonatophenyl)diazen-1-yl]benzene-1-sulfonate (70210-30-9) was estimated to be 11351.07 mg/kg bw, and for different studies available on structurally similar read across substance LD50 was considered to be >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, tetrasodium 2-[(E)-2-{2-acetamido-4-[4-({3-acetamido-4-[(E)-2-{2-sulfonato-4-[(E)-2-(4-sulfonatophenyl)diazen-1-yl]phenyl} diazen-1-yl]phenyl}carbamoyl)benzamido]phenyl}diazen-1-yl]-5-[(E)-2-(4-sulfonatophenyl)diazen-1-yl]benzene-1-sulfonate (70210-30-9) cannot be classified for acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75d88290-72eb-4249-8a4e-e108168cece1/documents/87dd109c-8c49-4403-a7ef-7e15edf09d8b_81880b4c-cbfb-4bf0-b45d-cdd67290b6bb.html,,,,,, "Tetrasodium 2,2'-[1,4-phenylenebis[carbonylimino[2-acetamido-4,1-phenylene]azo]]bis[5-[(4-sulphonatophenyl)azo]benzenesulphonate]",70210-30-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75d88290-72eb-4249-8a4e-e108168cece1/documents/87dd109c-8c49-4403-a7ef-7e15edf09d8b_81880b4c-cbfb-4bf0-b45d-cdd67290b6bb.html,,oral,LD50,"3,842.59 mg/kg bw",no adverse effect observed, "Tetrasodium 2,2'-[1,4-phenylenebis[carbonylimino[2-acetamido-4,1-phenylene]azo]]bis[5-[(4-sulphonatophenyl)azo]benzenesulphonate]",70210-30-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/75d88290-72eb-4249-8a4e-e108168cece1/documents/87dd109c-8c49-4403-a7ef-7e15edf09d8b_81880b4c-cbfb-4bf0-b45d-cdd67290b6bb.html,,dermal,LD50,"11,351.07 mg/kg bw",no adverse effect observed, "Tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate",70161-16-9," NOAEL was considered to be in the rang of 100-1300 mg/kg bw for tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate orally. Thus, comparing this value with the criteria of CLP regulation tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate (70161 -16 -9) is not likely to classify as repeated dose toxicant. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce96345c-9532-4f8b-9fe3-f06d7a7c5f6b/documents/c47d1be2-686f-4df6-be87-22022500eb19_825a3aea-b15c-49b0-9d79-78ff88ad9630.html,,,,,, "Tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate",70161-16-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ce96345c-9532-4f8b-9fe3-f06d7a7c5f6b/documents/c47d1be2-686f-4df6-be87-22022500eb19_825a3aea-b15c-49b0-9d79-78ff88ad9630.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,300 mg/kg bw/day",,mouse "Tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate",70161-16-9," Acute oral Toxicity:  The acute oral toxicity dose (LD50) for tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate (CAS No. 70161-16-9) was based on data available for the structurally similar read across chemicals. The LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate (CAS No. 70161-16-9) cannot be classified for acute oral toxicity.  Acute Inhalation Toxicity: Tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate (CAS No. 70161-16-9) has very low vapour pressure (7.71E-34 Pa), so the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore this end point was considered for waiver.  Acute dermal Toxicity:  The acute dermal toxicity dose (LD50) for tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate (CAS No. 70161-16-9)was based on data available for the structurally similar read across chemicals. The LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate (CAS No. 70161-16-9)cannot be classified for acute dermal toxicity.  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce96345c-9532-4f8b-9fe3-f06d7a7c5f6b/documents/382f516a-1c01-4629-834d-ae16c7fb2ea3_825a3aea-b15c-49b0-9d79-78ff88ad9630.html,,,,,, "Tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate",70161-16-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce96345c-9532-4f8b-9fe3-f06d7a7c5f6b/documents/382f516a-1c01-4629-834d-ae16c7fb2ea3_825a3aea-b15c-49b0-9d79-78ff88ad9630.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Tetrasodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonato-1-naphthyl]azo]-7-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate",70161-16-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ce96345c-9532-4f8b-9fe3-f06d7a7c5f6b/documents/382f516a-1c01-4629-834d-ae16c7fb2ea3_825a3aea-b15c-49b0-9d79-78ff88ad9630.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetrasodium 2-[[4-[[4-[[1-hydroxy-6-(phenylamino)-3-sulphonato-2-naphthyl]azo]-1-naphthyl]azo]-6-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate",2503-73-3, Acute Toxicity- Oral point Only one study is available. Klimish score 2. LD50=9.822 g/kg (for male) Acute Toxicity - Dermal point Only one study is available. Klimish score 2. LD50 > 5 g/kg/bw (for male) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67738ede-6ea8-4392-8efb-3b3593e5f22b/documents/835f5f05-e4c8-4e5e-9b8f-011a680ef50c_2b1cbc92-b16f-4208-b6e8-24b1d942a57d.html,,,,,, "Tetrasodium 2-[[4-[[4-[[1-hydroxy-6-(phenylamino)-3-sulphonato-2-naphthyl]azo]-1-naphthyl]azo]-6-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate",2503-73-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67738ede-6ea8-4392-8efb-3b3593e5f22b/documents/835f5f05-e4c8-4e5e-9b8f-011a680ef50c_2b1cbc92-b16f-4208-b6e8-24b1d942a57d.html,,oral,LD50,"9,822 mg/kg bw",adverse effect observed, "Tetrasodium 2-[[4-[[4-[[1-hydroxy-6-(phenylamino)-3-sulphonato-2-naphthyl]azo]-1-naphthyl]azo]-6-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate",2503-73-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67738ede-6ea8-4392-8efb-3b3593e5f22b/documents/835f5f05-e4c8-4e5e-9b8f-011a680ef50c_2b1cbc92-b16f-4208-b6e8-24b1d942a57d.html,,dermal,LD50,"5,000 mg/kg bw",adverse effect observed, "Tetrasodium 2-[[8-[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]benzoyl]amino]-1-hydroxy-3,6-disulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate",68238-92-6," Oral LD50 (rat, male/female) > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17926ea7-1a53-49df-aa9b-51aee68306ef/documents/7672230a-dd21-4793-8562-517a8ad5a52b_feafd2e6-1a86-4283-8d03-339e437d1d1c.html,,,,,, "Tetrasodium 2-[[8-[[3-[(5-chloro-2,6-difluoro-4-pyrimidinyl)amino]benzoyl]amino]-1-hydroxy-3,6-disulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate",68238-92-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/17926ea7-1a53-49df-aa9b-51aee68306ef/documents/7672230a-dd21-4793-8562-517a8ad5a52b_feafd2e6-1a86-4283-8d03-339e437d1d1c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetrasodium 3,3'-[[6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]bis[imino(2-methyl-4,1-phenylene)azo]]bisnaphthalene-1,5-disulphonate",50925-42-3,"Repeated dose toxicity: OECD TG 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test), GLP, Results: NOAEL: 1000 mg/kg/day for general toxicity.  ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80000f21-6154-4193-a161-c014cd4cc750/documents/62cf57b3-5450-408f-b606-1ced794cd40a_b57672ea-8b0f-4bd9-ba59-d9c980e2dea0.html,,,,,, "Tetrasodium 3,3'-[[6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]bis[imino(2-methyl-4,1-phenylene)azo]]bisnaphthalene-1,5-disulphonate",50925-42-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80000f21-6154-4193-a161-c014cd4cc750/documents/62cf57b3-5450-408f-b606-1ced794cd40a_b57672ea-8b0f-4bd9-ba59-d9c980e2dea0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Tetrasodium 3,3'-[[6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]bis[imino(2-methyl-4,1-phenylene)azo]]bisnaphthalene-1,5-disulphonate",50925-42-3,"Acute Oral Toxicity: OECD TG 401, GLP-conform, LD50 > 2000 mg/kg bw, rats, 5 animals/sex, 2000 mg/kg bw, oral gavage, 14 days observation period.  No acute inhalation or dermal toxicity studies are available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80000f21-6154-4193-a161-c014cd4cc750/documents/662897ff-1744-4f91-80a7-1e8bad4bde07_b57672ea-8b0f-4bd9-ba59-d9c980e2dea0.html,,,,,, "Tetrasodium 3,3'-[[6-[(2-hydroxyethyl)amino]-1,3,5-triazine-2,4-diyl]bis[imino(2-methyl-4,1-phenylene)azo]]bisnaphthalene-1,5-disulphonate",50925-42-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80000f21-6154-4193-a161-c014cd4cc750/documents/662897ff-1744-4f91-80a7-1e8bad4bde07_b57672ea-8b0f-4bd9-ba59-d9c980e2dea0.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Tetrasodium 3,3'-[carbonylbis[imino(2-methyl-4,1-phenylene)azo]]bisnaphthalene-1,5-disulphonate",3214-47-9,"Acute toxicity oral: - KS, Expert Judgment: not classified (LD50 > 2000 mg/kg); - WoE, Boruta 1984: the test substance should not be classified for acute oral toxicity; - WoE, BASF 1973: for the test substance presented, the acute oral LD50 in rats was established to be > 15000 mg/Kg; - WoE, QSAR dyes - prediction tool: The substance was predicted to be not classified for the acute oral toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f99d9f50-841b-4d32-82a7-6f0d940312ff/documents/dca59a21-e742-4bfd-b273-9790a59ffaeb_b837fbaa-a6ed-4fa7-b8e5-73d41ac71128.html,,,,,, "Tetrasodium 3,3'-[carbonylbis[imino(2-methyl-4,1-phenylene)azo]]bisnaphthalene-1,5-disulphonate",3214-47-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f99d9f50-841b-4d32-82a7-6f0d940312ff/documents/dca59a21-e742-4bfd-b273-9790a59ffaeb_b837fbaa-a6ed-4fa7-b8e5-73d41ac71128.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetrasodium 3,3'-[carbonylbis[imino(5-methoxy-2-methyl-4,1-phenylene)azo]]bis(naphthalene-1,5-disulphonate)",6420-33-3," Three groups of ten male and ten female rats received the substance at doses of 30, 100 or 200 mg/kg/day by oral gavage administration. The 200 mg/kg bw dose was lowered to 125 mg/kg bw after two weeks of treatment due to bodyweight loss in both sexes and mortality in females. Males were treated daily for two weeks before pairing, up to necropsy after a minimum of five consecutive weeks. Females were treated daily for two weeks before pairing, throughout pairing, gestation and until Day 13 of lactation. Females were allowed to litter, rear their offspring and were killed on Day 14 of lactation. The F1 generation received no direct administration of the test item; any exposure was in utero or via the milk. A similarly constituted control group received the vehicle, corn oil, at the same volume-dose as treated groups. During the study, clinical condition, detailed physical examination and arena observations, sensory reactivity observations, grip strength, motor activity, body weight, food consumption, hematology (peripheral blood), blood chemistry, thyroid hormone analysis (T4), estrous cycles, pre-coital interval, mating performance, fertility, gestation length, organ weight and macroscopic pathology and histopathology investigations were undertaken. Treatment at 200 mg/kg bw/day revealed reduced body weight development for animals of either sex, which was also seen in the males receiving the test item at 100 mg/kg bw/day and above. The mean overall body weight gain in these animals at the end of the dose administration period was approximately 58% and 33% (200/125 and 100 mg/kg bw/day males, respectively) lower than controls. There were no effects evident in males treated with 30 mg/kg bw/day. The food intake and food conversion efficiency showed similar trends to body weight development for high dose males: no such effects were detected for males at 30 or 100 mg/kg bw/day. However, for females this remained unaffected by treatment throughout the study in comparison to controls. There were no detrimental effects on behavioural/functional or sensory performance at any dose level. The microscopic examination revealed adverse kidney changes in animals of either sex at 200/125 mg/kg bw/day and males at 100 mg/kg bw/day.  These changes mainly consisted of damage to the tubules but urothelial hyperplasia was also present. Crystalline deposits were also apparent and these may be due to deposition of the test item or its metabolites during the excretion process. The changes in the kidneys correlate with the macroscopic findings, changes in electrolytes and blood urea and with the weight increase evident for 200/125 and 100 mg/kg bw/day males. Adverse changes in the liver for all treatment groups were also apparent in a dose-related manner. Whilst bile duct hyperplasia occurred only in animals administered with 100 mg/kg bw/day and above there was an increased cell turnover noted in males and females from all dose groups, which included degeneration/apoptosis and an increase in mitosis. Diffuse inflammatory cell infiltration was seen only in males administered with 100 mg/kg bw/day and above.  Centrilobular hypertrophy was also noted in a few 30 mg/kg bw/day males and females from 100 or 200/125 mg/kg bw/day dose groups.  Vacuolation was seen occasionally in males at 30 or 100 mg/kg bw/day.  The pathology in the liver correlates with the clinical chemistry changes and the increase in liver weight in males. There was a marginal increase in hematopoiesis seen in the spleen of the high dose males; this correlated with a weight increase and is likely to be linked to the hematology changes. Therefore, due to the adverse microscopic changes to the kidney and liver a NOAEL for systemic toxicity could not be established for either sex. The lowest dose level 30 mg/kg bw is considered to be a LOAEL. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b692a7f2-7977-497e-9ca2-182f7d3b2231/documents/462b2488-37f5-4c2d-a315-5965ad50a298_320d5dcc-c8d7-4295-b456-d1df48efb24f.html,,,,,, "Tetrasodium 3,3'-[carbonylbis[imino(5-methoxy-2-methyl-4,1-phenylene)azo]]bis(naphthalene-1,5-disulphonate)",6420-33-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b692a7f2-7977-497e-9ca2-182f7d3b2231/documents/462b2488-37f5-4c2d-a315-5965ad50a298_320d5dcc-c8d7-4295-b456-d1df48efb24f.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,30 mg/kg bw/day,,rat "Tetrasodium 3,3'-[carbonylbis[imino(5-methoxy-2-methyl-4,1-phenylene)azo]]bis(naphthalene-1,5-disulphonate)",6420-33-3," In an acute oral study, rats (5/sex) received the substance by oral gavage at 5000 mg/kg bw. No effects on mortality, bodyweight or macroscopy were found after the 14 day observation period. On day 1 of the test hunched posture, piloerection and diarrhea were observed. The LD50 is > 5000 mg/kg bw (Safepharm 1985). Based on the information in an abstract from 1974 the dermal LD50 is > 4000 mg/kg bw As the substance does not show toxicity in the acute oral toxicity study, further testing via the dermal route was waived. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b692a7f2-7977-497e-9ca2-182f7d3b2231/documents/428688ea-fdce-4b64-bc3e-d3751360c0a6_320d5dcc-c8d7-4295-b456-d1df48efb24f.html,,,,,, "Tetrasodium 3,3'-[carbonylbis[imino(5-methoxy-2-methyl-4,1-phenylene)azo]]bis(naphthalene-1,5-disulphonate)",6420-33-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b692a7f2-7977-497e-9ca2-182f7d3b2231/documents/428688ea-fdce-4b64-bc3e-d3751360c0a6_320d5dcc-c8d7-4295-b456-d1df48efb24f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetrasodium 3,3'-[carbonylbis[imino(5-methoxy-2-methyl-4,1-phenylene)azo]]bis(naphthalene-1,5-disulphonate)",6420-33-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b692a7f2-7977-497e-9ca2-182f7d3b2231/documents/428688ea-fdce-4b64-bc3e-d3751360c0a6_320d5dcc-c8d7-4295-b456-d1df48efb24f.html,,dermal,LD50,"4,000 mg/kg bw",no adverse effect observed, "Tetrasodium 3-[[4-[[4,6-bis-[(3-sulfonatoprop-1-yl)thio]-1,3,5-triazin-2-yl]amino]-2-methyl-5-methoxy-phenyl]azonaphthalene-1,5-disulfonate",187674-70-0,"4 week repeated dose oral toxicity: NOAEL 1350 mg/kg bw/day, OECD 407, EU Method B.7 and Japanese guidelines (Notification No. 700 of the Environmental Agency, No. 1039 of the Ministry of Health and Welfare and No. 1014 of Ministry of International Trade and Industry), Fabreguettes 1996 ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b5a5181-f461-4908-aa27-5430a22bd6a0/documents/IUC5-8a6547c1-8d04-49ad-ba4c-d581c59392ef_28e732b9-c487-409b-acdf-8288f5c2f878.html,,,,,, "Tetrasodium 3-[[4-[[4,6-bis-[(3-sulfonatoprop-1-yl)thio]-1,3,5-triazin-2-yl]amino]-2-methyl-5-methoxy-phenyl]azonaphthalene-1,5-disulfonate",187674-70-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/5b5a5181-f461-4908-aa27-5430a22bd6a0/documents/IUC5-8a6547c1-8d04-49ad-ba4c-d581c59392ef_28e732b9-c487-409b-acdf-8288f5c2f878.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,350 mg/kg bw/day",,rat "Tetrasodium 3-[[4-[[4,6-bis-[(3-sulfonatoprop-1-yl)thio]-1,3,5-triazin-2-yl]amino]-2-methyl-5-methoxy-phenyl]azonaphthalene-1,5-disulfonate",187674-70-0,"Oral Toxicity: LD50 > 2000 mg/kg bw, OECD 401, EU Method B1, Jouffrey 1995.Dermal Toxcicity: LD50 > 2000 mg/kg bw, OECD 402, EU Method B3, Jouffery 1996. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5b5a5181-f461-4908-aa27-5430a22bd6a0/documents/IUC5-965534a1-7f60-480c-a8d5-4b0d18ffa1dd_28e732b9-c487-409b-acdf-8288f5c2f878.html,,,,,, "Tetrasodium 3-[[5-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl]azo]-4-hydroxy-5-[(1-oxopropyl)amino]naphthalene-2,7-disulphonate",80019-42-7," Data available for the structurally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Tetrasodium 3-[[5-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl]azo]-4-hydroxy-5-[(1-oxopropyl)amino]naphthalene-2,7-disulphonate(80019-42-7).The studies are as mentioned below: 1.Acute oral toxicity study was done infemale Sprague Dawley rats using test chemical.Distilled water was used as vehicle.Initially, three female animals were treated at the dose level of 300 mg/kg body weight of the test item (Step - I). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality at 24 hours after the dosing. As no mortality was observed at 24 hours after the dosing, three female animals were added to the study and treated with the same dose of 300 mg/kg of the test item (Step - II). Administration of the test item at 300 mg/kg did not result in any signs of toxicity and mortality after the dosing. No mortality was observed at 300 mg/kg dose group, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - I). Administration of the test item at 2000 mg/kg resulted in diarrhoea (black colour stools) in all animals with onset at 2 hours and no mortality after the dosing. As no mortality were observed at 24 hours after the dosing, hence additional three female animals were treated with the higher dose of 2000 mg/kg of the test item (Step - II). Administration of the test item at 2000 mg/kg resulted in diarrhoea (black colour stools) in all animals with onset at 4 hours and no mortality after the dosing. All animals from 300 mg/kg and 2000 mg/kg dose groups survived through the study period of 14 days. Staining of the stool is attributed to the black colour of the test item. Gross pathological examination did not reveal any abnormalities in animals from 300 mg/kg and 2000 mg/kg dose groups.Hence,LD50 value was considered to be5000 mg/kg bw,when female Sprague Dawleyrats were treated with test chemical orally via gavage following 14 days of observation period according to OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method). 2.A simple acute oral toxicity experiment was conducted prior to DNA damage in pregnant female CD1 mice. Samples of test chemical, was from certified lots approved for food use in Japan and was purchased from Tokyo Kasei Organic Chemicals (Tokyo). CD-1 (ICR) mice were obtained from Charles River Japan, Inc. (Yokohama) at 7 weeks of age and used for the experiments after 1 week of acclimatization. They were fed with commercial pellets MF (Oriental Yeast Industries, Tokyo) and tap waterad libitumthroughout the acclimatization period and the experiment. The animal room was kept at 22 ± 2°C with a 12-h light-dark cycle; the humidity was 30–50%. For the pregnant mouse study, female mice were mated for a period of one to two days. The morning on which copulation plugs were observed was designated day 0 of gestation. On the morning of day 11, 4 mice were randomly assigned to each treatment group. Chemicals were dissolved in distilled water and administered by gavage at the limit dose of 2000 mg/kg (10 ml/kg). The same volume of distilled water was administered to the control mice at the same time. The limit dose, at which no deaths, morbidity, or distinctive clinical signs were observed, was determined by preliminary acute toxicity tests. The Limit dose at which no mortality, morbidity or toxic signs were observed in mice dosed with test chemical was determined to be greater than 2000 mg/kg bw. Thus, based on the above summarised studies,Tetrasodium 3-[[5-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl]azo]-4-hydroxy-5-[(1-oxopropyl)amino]naphthalene-2,7-disulphonate(80019-42-7) and it’s structurallysimilarread across substance, it can be concluded that LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,Tetrasodium 3-[[5-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl]azo]-4-hydroxy-5-[(1-oxopropyl)amino]naphthalene-2,7-disulphonate(80019-42-7)cannot be classified for acute oral toxicity.Hence, based on the data available for the structurally similar read across, test chemicalTetrasodium 3-[[5-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl]azo]-4-hydroxy-5-[(1-oxopropyl)amino]naphthalene-2,7-disulphonate(80019-42-7)is not likely to be toxic at the dose range of >2000-5000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a61a44e-46e2-45bd-8320-f2ebf050032a/documents/33576d3e-f289-4735-804a-13b5e7125035_c98312eb-05a6-4d8b-9bbd-479d4d36222d.html,,,,,, "Tetrasodium 3-[[5-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl]azo]-4-hydroxy-5-[(1-oxopropyl)amino]naphthalene-2,7-disulphonate",80019-42-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a61a44e-46e2-45bd-8320-f2ebf050032a/documents/33576d3e-f289-4735-804a-13b5e7125035_c98312eb-05a6-4d8b-9bbd-479d4d36222d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Tetrasodium 4,4'-bis[[4-[(2-hydroxyethyl)amino]-6-(m-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",16324-27-9, NOAEL in male rats ≥ 750 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9da8785-9eee-4046-8b69-d302deba3ffe/documents/9fefda56-fdbd-4660-8ca7-2ade808cc086_cf567d01-9f5c-4713-a5af-ca8014f8b6d3.html,,,,,, "Tetrasodium 4,4'-bis[[4-[(2-hydroxyethyl)amino]-6-(m-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",16324-27-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9da8785-9eee-4046-8b69-d302deba3ffe/documents/9fefda56-fdbd-4660-8ca7-2ade808cc086_cf567d01-9f5c-4713-a5af-ca8014f8b6d3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat "Tetrasodium 4,4'-bis[[4-[(2-hydroxyethyl)amino]-6-(m-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",16324-27-9, Rat oral LD50 > 10000 mg/kg bw Rat inhalation LC50 > 1895 mg/m3 Rat dermal LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9da8785-9eee-4046-8b69-d302deba3ffe/documents/6c3fffc5-ee6b-4309-89f6-b2902869694e_cf567d01-9f5c-4713-a5af-ca8014f8b6d3.html,,,,,, "Tetrasodium 4,4'-bis[[4-[(2-hydroxyethyl)amino]-6-(m-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",16324-27-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9da8785-9eee-4046-8b69-d302deba3ffe/documents/6c3fffc5-ee6b-4309-89f6-b2902869694e_cf567d01-9f5c-4713-a5af-ca8014f8b6d3.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Tetrasodium 4,4'-bis[[4-[(2-hydroxyethyl)amino]-6-(m-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",16324-27-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9da8785-9eee-4046-8b69-d302deba3ffe/documents/6c3fffc5-ee6b-4309-89f6-b2902869694e_cf567d01-9f5c-4713-a5af-ca8014f8b6d3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetrasodium 4,4'-bis[[4-[(2-hydroxyethyl)amino]-6-(m-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",16324-27-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9da8785-9eee-4046-8b69-d302deba3ffe/documents/6c3fffc5-ee6b-4309-89f6-b2902869694e_cf567d01-9f5c-4713-a5af-ca8014f8b6d3.html,,inhalation,LC50,"1,895 mg/m3",no adverse effect observed, "Tetrasodium 4,4'-bis[[4-[bis(2-hydroxyethyl)amino]-6-(4-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate]",16470-24-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b632037e-f4c4-4171-989e-4317bca07776/documents/e0287130-aac2-4a8f-8ded-1a31b090a718_d875b280-e661-4313-b24a-dbc564c04c63.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Tetrasodium 4,4'-bis[[4-[bis(2-hydroxyethyl)amino]-6-(4-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate]",16470-24-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b632037e-f4c4-4171-989e-4317bca07776/documents/IUC5-32ae1cb8-36bf-4f34-9047-2503ef2bfdcf_d875b280-e661-4313-b24a-dbc564c04c63.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Tetrasodium 4,4'-bis[[4-[bis(2-hydroxyethyl)amino]-6-(4-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate]",16470-24-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b632037e-f4c4-4171-989e-4317bca07776/documents/IUC5-32ae1cb8-36bf-4f34-9047-2503ef2bfdcf_d875b280-e661-4313-b24a-dbc564c04c63.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetrasodium 4,4'-bis[[4-[bis(2-hydroxyethyl)amino]-6-(4-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate]",16470-24-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b632037e-f4c4-4171-989e-4317bca07776/documents/IUC5-32ae1cb8-36bf-4f34-9047-2503ef2bfdcf_d875b280-e661-4313-b24a-dbc564c04c63.html,,inhalation,LC50,"1,895 mg/m3",no adverse effect observed, "Tetrasodium 4,4'-bis[[4-[bis(2-hydroxypropyl)amino]-6-[(4-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-stilbene-2,2'-disulphonate",67786-25-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3cd62be3-170c-448c-957d-1b4aa8389bb6/documents/02a7e7cb-866d-41eb-91ed-92d008c18f64_023b77b6-de4f-4ffd-bce9-4813faa48976.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Tetrasodium 4,4'-bis[[4-[bis(2-hydroxypropyl)amino]-6-[(4-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-stilbene-2,2'-disulphonate",67786-25-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cd62be3-170c-448c-957d-1b4aa8389bb6/documents/9dec20e6-f7b6-41ac-8628-9dd824c1d108_023b77b6-de4f-4ffd-bce9-4813faa48976.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Tetrasodium 4,4'-bis[[4-[bis(2-hydroxypropyl)amino]-6-[(4-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-stilbene-2,2'-disulphonate",67786-25-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cd62be3-170c-448c-957d-1b4aa8389bb6/documents/9dec20e6-f7b6-41ac-8628-9dd824c1d108_023b77b6-de4f-4ffd-bce9-4813faa48976.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetrasodium 4,4'-bis[[4-[bis(2-hydroxypropyl)amino]-6-[(4-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-stilbene-2,2'-disulphonate",67786-25-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3cd62be3-170c-448c-957d-1b4aa8389bb6/documents/9dec20e6-f7b6-41ac-8628-9dd824c1d108_023b77b6-de4f-4ffd-bce9-4813faa48976.html,,inhalation,LC50,"1,895 mg/m3",no adverse effect observed, "Tetrasodium 4,4'-bis[[4-morpholino-6-(p-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",28950-61-0," Acute Oral Toxicity: An acute oral toxicity study in female Wistar rat was carried out with FAT 66042/A according to OECD guideline 423 and EU method B.1. Two groups, each of three female HanRcc:WIST (SPF) rats, were treated with test item by oral gavage administration at a dosage of 2000 mg/kg body weight. The test item was diluted in vehicle (PEG 300) at a concentration of 0.2 g/ml and administered at a dosing volume of 10 ml/kg. The animals were examined daily during the acclimatization period and mortality, viability and clinical signs were recorded. All animals were examined for clinical signs within the first 30 minutes and approximately 1, 2, 3 and 5 hours after treatment on day 1 and once daily during test days 2-15. Mortality/viability was recorded at approximately 30 minutes, 1, 2, 3 and 5 hours after administration on test day 1 (with the clinical signs) and twice daily during days 2-15. Body weights were recorded on day 1 (prior to administration) and on days 8 and 15. All animals were necropsied and examined macroscopically. All animals survived until the end of the study period. Soft feces were recorded in one animal at the 3-hour observation. Otherwise, no clinical signs were observed during the course of the study. The body weight of the animals was within the range commonly recorded for this strain and age. No macroscopic findings were recorded at necropsy. The median lethal dose (LD50) of FAT 66042/A after single oral administration to female Wistar rats, observed over a period of 14 days is greater than 2000 mg/kg body weight. Acute Inhalation Toxicity: Currently no study to assess acute inhalation toxicity of Stilbene optical brightener is available.However, low vapour pressure owing to high melting point (>350 °C), the substance is considered to have low volatility. Synthesis of this chemical is performed in a closed process; the final product consists of non-dusty granules. Hence, the use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalation route will be unlikely to occur. Based on column 2, ‘Specific rules for adaptation from column 1’ of the table given in REACH Annex VII, the study on acute inhalation toxicity only needs to be conducted if an exposure via inhalation is to be expected, based on vapour pressure and/or the likelihood of an exposure to aerosols, particles or droplets. The chemical showed low toxicity potential in the available acute oral (LD50>2000 mg/kg bw) with no mortality or systemic toxicity, hence it does not need to be classified as STOT SE. Taking into consideration the above arguments, low toxicity potential is expected on acute exposure ofStilbene optical brightenervia inhalation route. Acute Dermal Toxicity: Currently no study to assess the acute dermal toxicity of Stilbene optical brightener is available. However, it has water solubility of 380 g/L and n-octanol/water partition coefficient (log P) of -3.392, indicating it being too hydrophilic to cross the lipid rich environment of thestratum corneum. Synthesis of this chemical is performed in a closed process without isolation of reaction products. Isolated products consist of either liquid formulations or dust free granules (non-dusty solid). In addition, the use of this substance will not result in aerosols, particles or droplets, so exposure to humans via the dermal route will be unlikely to occur.The chemical showed low toxicity potential in the available acute oral (LD50>2000 mg/kg bw), with no mortality or systemic toxicity, hence it does not need to be classified as STOT SE.Similarly, absence of local toxicity in eye and skin irritation studies as well as absence of systemic toxicity in sensitization studies, further supports the conclusion that low toxicity is expected for the chemical via the dermal route. Taking into consideration the above arguments, low toxicity potential is expected on acute exposure of Stilbene optical brightener via dermal route and hence acute toxicity testing by the dermal route was considered scientifically not necessary. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d5dbfe5-29f1-4fd9-a8eb-4a50a227c6f6/documents/fdf570d6-0033-4173-b77a-bcc0fd458e86_469d2989-5014-4c93-9a42-f4f110ae2c68.html,,,,,, "Tetrasodium 4,4'-bis[[4-morpholino-6-(p-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate",28950-61-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0d5dbfe5-29f1-4fd9-a8eb-4a50a227c6f6/documents/fdf570d6-0033-4173-b77a-bcc0fd458e86_469d2989-5014-4c93-9a42-f4f110ae2c68.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetrasodium 4-amino-5-hydroxy-6-[[2-methoxy-5-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate",93951-21-4,"No toxicological relevant adverse effect was seen in any of the short-term repeat dose studies with close structural analogues used for assessment. The NOAEL was therefore considered to be above 1000 mg/kg bw/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): High quality database. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd36c939-cb56-4cd8-9f31-cb82131242ef/documents/IUC5-18dc4889-3621-4377-a763-f535deba405a_7dae00c0-d20d-48ce-8605-fe3264c8a3db.html,,,,,, "Tetrasodium 4-amino-5-hydroxy-6-[[2-methoxy-5-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate",93951-21-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd36c939-cb56-4cd8-9f31-cb82131242ef/documents/IUC5-18dc4889-3621-4377-a763-f535deba405a_7dae00c0-d20d-48ce-8605-fe3264c8a3db.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Tetrasodium 4-amino-5-hydroxy-6-[[2-methoxy-5-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate",93951-21-4,The test substance is practically non-toxic. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd36c939-cb56-4cd8-9f31-cb82131242ef/documents/IUC5-d1aaf27c-0c8d-4ec3-ae63-9a6155ec2936_7dae00c0-d20d-48ce-8605-fe3264c8a3db.html,,,,,, "Tetrasodium 4-amino-5-hydroxy-6-[[2-methoxy-5-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate",93951-21-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd36c939-cb56-4cd8-9f31-cb82131242ef/documents/IUC5-d1aaf27c-0c8d-4ec3-ae63-9a6155ec2936_7dae00c0-d20d-48ce-8605-fe3264c8a3db.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Tetrasodium 4-amino-6-[[2,5-dimethoxy-4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-5-hydroxy-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate",84229-70-9,No adverse effects observed after repeated administration. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa784d08-bdcd-4d1f-843c-b1217d777934/documents/b7dbd237-e003-463e-9be6-b74ad4d89e40_dffee0ec-9794-4726-9555-db9fcf5e350c.html,,,,,, "Tetrasodium 4-amino-6-[[2,5-dimethoxy-4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-5-hydroxy-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate",84229-70-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa784d08-bdcd-4d1f-843c-b1217d777934/documents/b7dbd237-e003-463e-9be6-b74ad4d89e40_dffee0ec-9794-4726-9555-db9fcf5e350c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,">= 1,000 mg/kg bw/day",,rat "Tetrasodium 4-amino-6-[[2,5-dimethoxy-4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-5-hydroxy-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate",84229-70-9,The test substance is practically non-toxic. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa784d08-bdcd-4d1f-843c-b1217d777934/documents/f76b4761-be8b-41ad-ad59-d3ea5f2188b8_dffee0ec-9794-4726-9555-db9fcf5e350c.html,,,,,, "Tetrasodium 4-amino-6-[[2,5-dimethoxy-4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-5-hydroxy-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate",84229-70-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa784d08-bdcd-4d1f-843c-b1217d777934/documents/f76b4761-be8b-41ad-ad59-d3ea5f2188b8_dffee0ec-9794-4726-9555-db9fcf5e350c.html,,oral,LD0,"> 5,000 mg/kg bw",no adverse effect observed, "Tetrasodium 4-amino-6-[[2,5-dimethoxy-4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]-5-hydroxy-3-[[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]azo]naphthalene-2,7-disulphonate",84229-70-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa784d08-bdcd-4d1f-843c-b1217d777934/documents/f76b4761-be8b-41ad-ad59-d3ea5f2188b8_dffee0ec-9794-4726-9555-db9fcf5e350c.html,,dermal,LD0,"> 2,000 mg/kg bw",no adverse effect observed, "Tetrasodium 5-[[2,4-dihydroxy-5-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]phenyl]azo]-4-hydroxy-3-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]naphthalene-2,7-disulphonate",70210-34-3, No biologically significant signs of toxicity were observed. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c21e668-edff-4666-841b-7ec09225b7d6/documents/bf9b8c9d-671d-4408-9a58-65b1003a497f_7e2b4dbd-e8b9-48dd-b202-5e252543cc75.html,,,,,, "Tetrasodium 5-[[2,4-dihydroxy-5-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]phenyl]azo]-4-hydroxy-3-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]naphthalene-2,7-disulphonate",70210-34-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c21e668-edff-4666-841b-7ec09225b7d6/documents/bf9b8c9d-671d-4408-9a58-65b1003a497f_7e2b4dbd-e8b9-48dd-b202-5e252543cc75.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Tetrasodium 5-[[2,4-dihydroxy-5-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]phenyl]azo]-4-hydroxy-3-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]naphthalene-2,7-disulphonate",70210-34-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c21e668-edff-4666-841b-7ec09225b7d6/documents/IUC5-f2b06b36-7164-4007-a7e3-c6f94c1c80b0_7e2b4dbd-e8b9-48dd-b202-5e252543cc75.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetrasodium 5-[[2,4-dihydroxy-5-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]phenyl]azo]-4-hydroxy-3-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]naphthalene-2,7-disulphonate",70210-34-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c21e668-edff-4666-841b-7ec09225b7d6/documents/IUC5-f2b06b36-7164-4007-a7e3-c6f94c1c80b0_7e2b4dbd-e8b9-48dd-b202-5e252543cc75.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(2-methyl-4-sulphonatophenyl)azo]naphthalene-2-sulphonate]",28706-33-4, NOEL (30d) (male and female) ≥ 1000 mg/kg bw/day (nominal) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/282fe4e4-67f7-49f4-8c55-abf65f5a08bd/documents/dfb30cb8-8df8-45d1-9238-1d852ba6cac7_7a252a51-b4c4-40ea-8d44-0ddee9348199.html,,,,,, "Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(2-methyl-4-sulphonatophenyl)azo]naphthalene-2-sulphonate]",28706-33-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/282fe4e4-67f7-49f4-8c55-abf65f5a08bd/documents/dfb30cb8-8df8-45d1-9238-1d852ba6cac7_7a252a51-b4c4-40ea-8d44-0ddee9348199.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(2-methyl-4-sulphonatophenyl)azo]naphthalene-2-sulphonate]",28706-33-4, Not acutely harmful/toxic by oral route. Not expected to be acutely harmful/toxic by dermal route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/282fe4e4-67f7-49f4-8c55-abf65f5a08bd/documents/2e2497b8-0043-442c-ae61-29c376fabb65_7a252a51-b4c4-40ea-8d44-0ddee9348199.html,,,,,, "Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(2-methyl-4-sulphonatophenyl)azo]naphthalene-2-sulphonate]",28706-33-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/282fe4e4-67f7-49f4-8c55-abf65f5a08bd/documents/2e2497b8-0043-442c-ae61-29c376fabb65_7a252a51-b4c4-40ea-8d44-0ddee9348199.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(2-methyl-4-sulphonatophenyl)azo]naphthalene-2-sulphonate]",28706-33-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/282fe4e4-67f7-49f4-8c55-abf65f5a08bd/documents/2e2497b8-0043-442c-ae61-29c376fabb65_7a252a51-b4c4-40ea-8d44-0ddee9348199.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(6-sulphonato-2-naphthyl)azo]naphthalene-2-sulphonate]",28706-25-4,No adverse effects were observed in a subacute oral (gavage) toxicity study in rats with the read across substance Analogue substance 1 at 1000 mg/kg/day (highest dose tested). The study predated GLP and OECD guidelines. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/523a8395-150b-423a-a195-79018db4dac6/documents/IUC5-aef7e8bf-c4a2-4c36-93c2-2f69ed704d74_aaa3ffeb-0235-4958-98aa-70a679ee0073.html,,,,,, "Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(6-sulphonato-2-naphthyl)azo]naphthalene-2-sulphonate]",28706-25-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/523a8395-150b-423a-a195-79018db4dac6/documents/IUC5-aef7e8bf-c4a2-4c36-93c2-2f69ed704d74_aaa3ffeb-0235-4958-98aa-70a679ee0073.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(6-sulphonato-2-naphthyl)azo]naphthalene-2-sulphonate]",28706-25-4,Oral LD50  > 5000 mg/kg bw for rat (limit test; test material contained 89% active ingredient and 10% urea)Dermal LD50 > 5 mL/kg bw for rat (limit test) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/523a8395-150b-423a-a195-79018db4dac6/documents/IUC5-0fa3c02f-c8e1-4c17-aaf8-5077ea93373e_aaa3ffeb-0235-4958-98aa-70a679ee0073.html,,,,,, "Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(6-sulphonato-2-naphthyl)azo]naphthalene-2-sulphonate]",28706-25-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/523a8395-150b-423a-a195-79018db4dac6/documents/IUC5-0fa3c02f-c8e1-4c17-aaf8-5077ea93373e_aaa3ffeb-0235-4958-98aa-70a679ee0073.html,,oral,LD50,"5,000 mg/kg bw",, "Tetrasodium 7,7'-(carbonyldiimino)bis[4-hydroxy-3-[(6-sulphonato-2-naphthyl)azo]naphthalene-2-sulphonate]",28706-25-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/523a8395-150b-423a-a195-79018db4dac6/documents/IUC5-0fa3c02f-c8e1-4c17-aaf8-5077ea93373e_aaa3ffeb-0235-4958-98aa-70a679ee0073.html,,dermal,LD50,"5,000 mg/kg bw",, "Tetrasodium 7,7'-[[6-(morpholin-4-yl)-1,3,5-triazine-2,4-diyl]diimino]bis[4-hydroxy-3-[(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate]",2184-11-4," In the acute oral test, the test dose was 5 g/kg b.w.. Result showed that all treated rats survived till the end of the study and there was no significant gross lesions founded during the gross necropsy examination. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51b25523-3165-4afb-ad79-0ce2ba17cb95/documents/115d66ef-8454-4386-a885-e851941dabec_75b13f97-dac4-45e6-ba61-34e855630f72.html,,,,,, "Tetrasodium 7,7'-[[6-(morpholin-4-yl)-1,3,5-triazine-2,4-diyl]diimino]bis[4-hydroxy-3-[(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate]",2184-11-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/51b25523-3165-4afb-ad79-0ce2ba17cb95/documents/115d66ef-8454-4386-a885-e851941dabec_75b13f97-dac4-45e6-ba61-34e855630f72.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Tetrasodium 7-[[2-[(aminocarbonyl)amino]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]phenyl]azo]naphthalene-1,3,6-trisulphonate",80157-00-2, Acute Oral Toxicity LD50 = 11205 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c967a738-66d8-4f0c-8f11-fdce6be64bad/documents/b068b56f-3391-48a4-8b7f-a66fd4b9fb86_65770789-9fc7-4139-9b5a-262ba177063c.html,,,,,, "Tetrasodium 7-[[2-[(aminocarbonyl)amino]-4-[[4-chloro-6-[[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]phenyl]azo]naphthalene-1,3,6-trisulphonate",80157-00-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c967a738-66d8-4f0c-8f11-fdce6be64bad/documents/b068b56f-3391-48a4-8b7f-a66fd4b9fb86_65770789-9fc7-4139-9b5a-262ba177063c.html,,oral,LD50,"11,205 mg/kg bw",no adverse effect observed, "Tetrasodium 7-[[4-[[4,6-bis[(3-sulfonatopropyl)thio]-1,3,5-triazin-2-yl]amino]-3-methoxyphenyl]azo]naphthalene-1,3-disulfonate",214559-61-2,"Oral (28 days) NOAEL = 600 mg/kg bw/day, male/female rat, EU Method B.7, Lortie 2002 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c7a9671-5242-40c4-b4cf-6d592832057a/documents/IUC5-d19c140e-3e04-4c04-ba17-fc2392b5b08b_16d8cc75-3943-484f-8b5f-cced600c40cd.html,,,,,, "Tetrasodium 7-[[4-[[4,6-bis[(3-sulfonatopropyl)thio]-1,3,5-triazin-2-yl]amino]-3-methoxyphenyl]azo]naphthalene-1,3-disulfonate",214559-61-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9c7a9671-5242-40c4-b4cf-6d592832057a/documents/IUC5-d19c140e-3e04-4c04-ba17-fc2392b5b08b_16d8cc75-3943-484f-8b5f-cced600c40cd.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,600 mg/kg bw/day,,rat "Tetrasodium 7-[[4-[[4,6-bis[(3-sulfonatopropyl)thio]-1,3,5-triazin-2-yl]amino]-3-methoxyphenyl]azo]naphthalene-1,3-disulfonate",214559-61-2,"Oral: LD50 = > 2000 mg/kg bw, male/female rat, OECD 401, EU Method B.1, Manciaux 1998Dermal: LD50 = > 2000 mg/kg bw, male/female rat, OECD 402, EU Method B.3, Pelcot 2002 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9c7a9671-5242-40c4-b4cf-6d592832057a/documents/IUC5-222cc5d1-c247-4052-aa2c-3ca97a9ab7a5_16d8cc75-3943-484f-8b5f-cced600c40cd.html,,,,,, Tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate,70210-31-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliability 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Reliability 2 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/484e9ce1-1ba3-4550-83c3-35d4431cc74d/documents/424411d4-b5ce-44ff-8cd2-87ebbfb966e0_d34906de-610e-425f-9c0d-459057c3c3cd.html,,,,,, Tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate,70210-31-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/484e9ce1-1ba3-4550-83c3-35d4431cc74d/documents/424411d4-b5ce-44ff-8cd2-87ebbfb966e0_d34906de-610e-425f-9c0d-459057c3c3cd.html,,oral,discriminating dose,"9,607 mg/kg bw",adverse effect observed, Tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate,70210-31-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/484e9ce1-1ba3-4550-83c3-35d4431cc74d/documents/424411d4-b5ce-44ff-8cd2-87ebbfb966e0_d34906de-610e-425f-9c0d-459057c3c3cd.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Tetrasodium enneatitanium icosaoxide hydrate,117314-20-2,"Oral (gavage) combined repeated dose and reproduction/developmental screening study, subacute, daily dose levels of 100, 300 and 1000 mg/kg bw/day, Rat (Wistar strain): NOEL = 1000 mg/kg bw/day (actual dose received) (male/female) - (GLP, OECD Guideline 422) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6da4de6d-3840-4cd5-8d4e-fb0aa3ba7d3c/documents/IUC5-23e37cac-5286-4106-a7d7-fffa028cc9f2_f7dbc5b3-6e54-475e-b203-ee823ec16222.html,,,,,, Tetrasodium enneatitanium icosaoxide hydrate,117314-20-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6da4de6d-3840-4cd5-8d4e-fb0aa3ba7d3c/documents/IUC5-23e37cac-5286-4106-a7d7-fffa028cc9f2_f7dbc5b3-6e54-475e-b203-ee823ec16222.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tetrasodium enneatitanium icosaoxide hydrate,117314-20-2,"Acute toxicity: Acute (single dose, fixed dose method) Oral (gavage) Toxicity Study, Rat (Wistar strain) f - (GLP, OECD Guideline 420, EU Method B1 bis): LD50 >2000 mg/kg bw (actual dose received) (female). Acute (24-hour, fixed dose method) Dermal (semiocclusive) Toxicity Study (Limit Test), Rat (Wistar Strain) m/f - (GLP, OECD Guideline 402, EU method B3): LD50 >2000 mg/kg bw (actual dose received) (male/female) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6da4de6d-3840-4cd5-8d4e-fb0aa3ba7d3c/documents/IUC5-bc41e583-5ad4-4613-8ed8-65d02c6d194d_f7dbc5b3-6e54-475e-b203-ee823ec16222.html,,,,,, Tetrasodium enneatitanium icosaoxide hydrate,117314-20-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6da4de6d-3840-4cd5-8d4e-fb0aa3ba7d3c/documents/IUC5-bc41e583-5ad4-4613-8ed8-65d02c6d194d_f7dbc5b3-6e54-475e-b203-ee823ec16222.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetrasodium enneatitanium icosaoxide hydrate,117314-20-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6da4de6d-3840-4cd5-8d4e-fb0aa3ba7d3c/documents/IUC5-bc41e583-5ad4-4613-8ed8-65d02c6d194d_f7dbc5b3-6e54-475e-b203-ee823ec16222.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate",66669-53-2," A 3-months feeding study in rats with technical tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate (50, 200, 1000, 5000 ppm = male rats: 0, 4.17, 14.91, 84.11, 424.41 mg/kg bw/day, female rats: 0, 6.05, 12.51, 125.48, 632.65 mg/kg bw/day ) results in a NOAEL equal or higher than 5000 ppm (equivalent to about 424 mg/kg bw/day for male rats and 632 mg/kg bw/day for female rats). Conclusion for subchronic exposure: Low toxicity, no damage in oral doses up to 424 mg/kg/body weight/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/202d7c8e-e6ba-4dff-bf9d-b041da7826c7/documents/IUC5-b8ca99b6-9358-4947-b5bb-6159f82b712f_6a457633-99a5-4353-8915-73ca7a07e488.html,,,,,, "Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate",66669-53-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/202d7c8e-e6ba-4dff-bf9d-b041da7826c7/documents/IUC5-b8ca99b6-9358-4947-b5bb-6159f82b712f_6a457633-99a5-4353-8915-73ca7a07e488.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,424 mg/kg bw/day,,rat "Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate",66669-53-2," Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate was tested for acute oral (gavage) toxicity in 10 male rats by single applications that were well tolerated by all animals. The LD50 found was ca. 8300 mg/kg bw . This result is supported by an analogue study with tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate also in 10 rats. The LD50 (rat, oral) found was >1300 mg/kg based on active ingredient of a 32.6 % aqueous solution of tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate. Thus, tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate is not classified as acute toxic (oral route). Acute inhalation toxicity was determined for the test substance tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate. The LC50 (inhalation, rat) of tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate is >1979 mg/m³. A dose level of 1300 mg/kg of the test substance tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate (32.6 % aqueous solution) was examined for acute dermal toxicity resulting in a LD50 (dermal, rat) of > 1300 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/202d7c8e-e6ba-4dff-bf9d-b041da7826c7/documents/IUC5-50b9f72d-ceb1-4d3f-bbe2-06c3a1d3d88c_6a457633-99a5-4353-8915-73ca7a07e488.html,,,,,, "Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate",66669-53-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/202d7c8e-e6ba-4dff-bf9d-b041da7826c7/documents/IUC5-50b9f72d-ceb1-4d3f-bbe2-06c3a1d3d88c_6a457633-99a5-4353-8915-73ca7a07e488.html,,oral,LD50,"8,300 mg/kg bw",adverse effect observed, "Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate",66669-53-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/202d7c8e-e6ba-4dff-bf9d-b041da7826c7/documents/IUC5-50b9f72d-ceb1-4d3f-bbe2-06c3a1d3d88c_6a457633-99a5-4353-8915-73ca7a07e488.html,,dermal,discriminating dose,"1,300 mg/kg bw",no adverse effect observed, "Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate",66669-53-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/202d7c8e-e6ba-4dff-bf9d-b041da7826c7/documents/IUC5-50b9f72d-ceb1-4d3f-bbe2-06c3a1d3d88c_6a457633-99a5-4353-8915-73ca7a07e488.html,,inhalation,discriminating conc.,"1,979 mg/m3",no adverse effect observed, "Tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-3-methylazobenzene",124605-82-9,28 day oral repeated dose toxicity: NOAEL = 100 mg/kg bw ; OECD 407 Guideline Study ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d7ed691-552f-45d8-abde-0e2e3d3d0c2c/documents/IUC5-b65372a8-d766-4d7a-a5df-b8d1d90c8628_a93577b6-8d5a-44a6-93fb-864c19808145.html,,,,,, "Tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-3-methylazobenzene",124605-82-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3d7ed691-552f-45d8-abde-0e2e3d3d0c2c/documents/IUC5-b65372a8-d766-4d7a-a5df-b8d1d90c8628_a93577b6-8d5a-44a6-93fb-864c19808145.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-3-methylazobenzene",124605-82-9,"Acute oral toxicity: LD50 > 2000 mg/kg bw (rat); OECD Guideline Study, RCC 1990Acute dermal toxicity: LD50 > 2000 mg/kg bw (rat); OECD Guideline Study, RCC 1990 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d7ed691-552f-45d8-abde-0e2e3d3d0c2c/documents/IUC5-94e850ae-b523-45bf-9305-772a68d90483_a93577b6-8d5a-44a6-93fb-864c19808145.html,,,,,, "Tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-3-methylazobenzene",124605-82-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d7ed691-552f-45d8-abde-0e2e3d3d0c2c/documents/IUC5-94e850ae-b523-45bf-9305-772a68d90483_a93577b6-8d5a-44a6-93fb-864c19808145.html,,oral,LD50,"2,000 mg/kg bw",, "Tetra-sodium/lithium 4,4'-bis-(8-amino-3,6-disulfonato-1-naphthol-2-ylazo)-3-methylazobenzene",124605-82-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3d7ed691-552f-45d8-abde-0e2e3d3d0c2c/documents/IUC5-94e850ae-b523-45bf-9305-772a68d90483_a93577b6-8d5a-44a6-93fb-864c19808145.html,,dermal,LD50,"2,000 mg/kg bw",, Tetravinylsilane,1112-55-6," ""A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test"" was performed to assess the repeated-dose, reproductive and developmental toxicities of test item in accordance with OECD 422. the No-Observed-Adverse-Effect Level (NOAEL) for repeated-dose toxicity under the conditions tested was considered to be 30 mg/kg/day due to decreases in body weights and food consumption, an increase in relative weight of the liver and centrilobular hypertrophy of the hepatocytes in the 100 and 300 mg/kg groups. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef33edfb-8991-4bb9-8a8e-9ef188492fbb/documents/3f93909d-7b8e-4122-bc2a-593f44b334cd_650f8f2d-11a0-46c1-bdf7-4dc987584492.html,,,,,, Tetravinylsilane,1112-55-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ef33edfb-8991-4bb9-8a8e-9ef188492fbb/documents/3f93909d-7b8e-4122-bc2a-593f44b334cd_650f8f2d-11a0-46c1-bdf7-4dc987584492.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat Tetravinylsilane,1112-55-6,Oral:A GLP compliant study was conducted to determine acute oral toxicity of test item according to OECD 423. The LD50 cut off value of test item defined as 5000 mg/kg bw or unclassified since no mortalities or moribundities occurred at 2000 mg/kg bw.Inhalation:The acute inhalation toxicity of test after being snout only administrated to SD rats for 4 hours was assessed at the maximum attainable concentration of 2270 mg/m3 based on OECD 403. The acute inhalation LC50 in SD rats for test item was more than 2270 mg/m3 (2.27 mg/L).Dermal:The acute dermal toxicity of test item in Sprague Dawley rats was assessed based on OECD 402. The acute dermal LD50 in rats for test item was estimated to be more than 2000 mg/kg b.w.. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef33edfb-8991-4bb9-8a8e-9ef188492fbb/documents/ddffdab3-0a1f-40d5-8a63-b1ca91fba5ed_650f8f2d-11a0-46c1-bdf7-4dc987584492.html,,,,,, Tetravinylsilane,1112-55-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef33edfb-8991-4bb9-8a8e-9ef188492fbb/documents/ddffdab3-0a1f-40d5-8a63-b1ca91fba5ed_650f8f2d-11a0-46c1-bdf7-4dc987584492.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Tetravinylsilane,1112-55-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef33edfb-8991-4bb9-8a8e-9ef188492fbb/documents/ddffdab3-0a1f-40d5-8a63-b1ca91fba5ed_650f8f2d-11a0-46c1-bdf7-4dc987584492.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tetravinylsilane,1112-55-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ef33edfb-8991-4bb9-8a8e-9ef188492fbb/documents/ddffdab3-0a1f-40d5-8a63-b1ca91fba5ed_650f8f2d-11a0-46c1-bdf7-4dc987584492.html,,inhalation,LC50,"2,270 mg/m3",no adverse effect observed, Tetrazinc trioxide phosphite,64539-51-1," In a reliable acute toxicity study the substance was administered to female Wistar rats (5 animals/dose) by oral gavage at a dose level of 2000 mg/kg bw (single administration). There were no mortalities or signs of clinical toxicity, mean body weight gain was as expected and no abnormalities found at macroscopic post-mortem examination.The oral LD50 is >2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c2ac50e-05aa-410e-821d-d08ed667a524/documents/698b8196-64c5-4d25-afe0-d5c73b3c26be_15ed5c87-3686-4046-aa7f-3439763dcc7f.html,,,,,, Tetrazinc trioxide phosphite,64539-51-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c2ac50e-05aa-410e-821d-d08ed667a524/documents/698b8196-64c5-4d25-afe0-d5c73b3c26be_15ed5c87-3686-4046-aa7f-3439763dcc7f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Thermomycolin,52233-31-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available information comprises an adequate, reliable (Klimisch score 1) study from source substances with similar structure and intrinsic properties. Read-across is justified based on common functional group(s), common precursors/breakdown products and similarities in PC/ECO/TOX properties (refer to endpoint discussion for further details). Taken together, the information from these independent sources is consistent and provides sufficient weight of evidence for hazard assessment leading to an endpoint conclusion in accordance with Annex XI, 1.2, of Regulation (EC) No 1907/2006. Therefore, the available information as a whole is sufficient to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb9b9f84-ffee-4167-b264-2dc6232e2732/documents/24b2293b-77be-4384-8057-810ec7b08765_73a1ff4b-a456-4259-85b7-16f2c4c44357.html,,,,,, Thermomycolin,52233-31-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb9b9f84-ffee-4167-b264-2dc6232e2732/documents/24b2293b-77be-4384-8057-810ec7b08765_73a1ff4b-a456-4259-85b7-16f2c4c44357.html,,oral,LD50,"1,800 mg/kg bw",adverse effect observed, "Thiazolidine-2,4-dione",2295-31-0," LD50 was considered to be 3267.0 mg/kg bw when Sprague-Dawley male and female rats were orally exposed with 1,3-thiazolidine-2,4-dione(2295-31-0). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2f2a9fa-2f99-422c-9d42-8b27dc126e10/documents/0495810c-e828-4d34-bf20-0fbbe3f4fd1e_6e46af8b-a017-4b2e-a429-3a4469ced8a8.html,,,,,, "Thiazolidine-2,4-dione",2295-31-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2f2a9fa-2f99-422c-9d42-8b27dc126e10/documents/0495810c-e828-4d34-bf20-0fbbe3f4fd1e_6e46af8b-a017-4b2e-a429-3a4469ced8a8.html,,oral,LD50,"3,267 mg/kg bw",no adverse effect observed, Thioacetic acid,507-09-5,"The acute oral LD50 of THIOACETIC ACID was comprised between 200 and  350mg/kg, in female rats. Hypoactivity or sedation, piloerection,  dyspnea, lateral recumbency, tonic-clonic convulsions and hypersalivation  were the clinical signs observed prior to death. The dermal LD0 of THIOACETIC ACID is equal to or higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b10c2db-cc92-4271-abe4-c8ee3878aa8c/documents/IUC5-b1298917-66e4-4716-af04-e13562046f84_af9b4137-52a3-482b-a3d4-b7bd8a634898.html,,,,,, Thioacetic acid,507-09-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b10c2db-cc92-4271-abe4-c8ee3878aa8c/documents/IUC5-b1298917-66e4-4716-af04-e13562046f84_af9b4137-52a3-482b-a3d4-b7bd8a634898.html,,oral,discriminating dose,200 mg/kg bw,adverse effect observed, Thioacetic acid,507-09-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b10c2db-cc92-4271-abe4-c8ee3878aa8c/documents/IUC5-b1298917-66e4-4716-af04-e13562046f84_af9b4137-52a3-482b-a3d4-b7bd8a634898.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Thiocyanic acid, (1,3,8,10-tetrahydro-1,3,8,10-tetraoxoanthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-2,9-diyl)di-3,1-phenylene ester, reaction products with sodium sulfide (Na2(Sx))",68585-53-5, In an acute oral toxicity study according to OECD guideline 423 a LD50 of above 2000 mg/kg bw was determined. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6751b627-8ce5-4adc-a706-466c729afb69/documents/c1777310-ef3b-4392-a1c4-203371235c96_c2f425d7-8cba-4238-8ac0-7be403a8699d.html,,,,,, "Thiocyanic acid, (1,3,8,10-tetrahydro-1,3,8,10-tetraoxoanthra[2,1,9-def:6,5,10-d'e'f']diisoquinoline-2,9-diyl)di-3,1-phenylene ester, reaction products with sodium sulfide (Na2(Sx))",68585-53-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6751b627-8ce5-4adc-a706-466c729afb69/documents/c1777310-ef3b-4392-a1c4-203371235c96_c2f425d7-8cba-4238-8ac0-7be403a8699d.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Thiodiethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]",41484-35-9, In a 90-day feeding study in rats adaptive changes in liver weights and minimal hepatocyte hypertrophy were the only relevant effects reported. The NOAEL was considered to be 138 mg/kg bw/day for males and 140 mg/kg bw/day for fermales. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3763252f-4203-488a-a11f-cf26a98178c4/documents/IUC5-61fe159b-dde7-4543-8652-44a2a41723fa_80379b8e-8d1a-4c6d-863d-3c238fa81ed1.html,,,,,, "Thiodiethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]",41484-35-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3763252f-4203-488a-a11f-cf26a98178c4/documents/IUC5-61fe159b-dde7-4543-8652-44a2a41723fa_80379b8e-8d1a-4c6d-863d-3c238fa81ed1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,138 mg/kg bw/day,,rat "Thiodiethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]",41484-35-9," oral: LD50 > 5000 mg/kg bw (rat), OECD Guideline Study. dermal: LD50 > 2000 mg/kg bw (rat), OECD Guideline Study (Read Across to structurally related substance) inhalation: no reliable data available, study is however not required according to Annex VIII (8.5) of the Official Journal of the European Union since two other routes are provided. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3763252f-4203-488a-a11f-cf26a98178c4/documents/IUC5-b8d369da-df11-4158-9111-ecd2b354ed43_80379b8e-8d1a-4c6d-863d-3c238fa81ed1.html,,,,,, "Thiodiethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]",41484-35-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3763252f-4203-488a-a11f-cf26a98178c4/documents/IUC5-b8d369da-df11-4158-9111-ecd2b354ed43_80379b8e-8d1a-4c6d-863d-3c238fa81ed1.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Thiodiethylene bis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate]",41484-35-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3763252f-4203-488a-a11f-cf26a98178c4/documents/IUC5-b8d369da-df11-4158-9111-ecd2b354ed43_80379b8e-8d1a-4c6d-863d-3c238fa81ed1.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Thionyl dichloride,7719-09-7,"Based on available reviews and handbooks, an experimental hydrolysis study in the gas phase and a recent guideline hydrolysis study according to OECD TG 111 “Hydrolysis as a Function of pH” it can be concluded that thionyl dichloride undergoes violent decomposition in aqueous milieu and decomposes quantitatively to HCl (CAS n° 7647-01-0) and SO2 (CAS n° 7446-09-5) with half-lives between 1.4 minutes and 5.9 minutes in the gas phase and < 2 minutes in water. SOCl2 is classified as R14 (Reacts violently with water). Since SOCl2 reacts vigorously and completely with water within minutes with formation of HCl and SO2 these hydrolysis products are considered relevant for the potential toxicity of thionyl dichloride.As outlined in the endpoint summary of IUCLID chapter 7.5, repeated dose toxicity, comprehensive data are available in animals and humans to evaluate the repeated dose toxicity of both hydrolysis products (e.g. HCl: OECD SIDS assessment published in 2002, SO2 and HCl: German Federal Institute for Occupational Safety and Health (BauA), TRGS900). Potential systemic effects are not seen in studies with HCl and SO2. There are sufficient data on thionyl dichloride and the hydrolysis products, to conclude that thionyl dichloride and both hydrolysis products are considered to be corrosive; thionyl dichloride is labeled with R35 (causes severe burns). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7efb2fb-89a2-46b9-865e-b44fed788244/documents/IUC5-55c12033-33b9-494d-9df2-aa14ed899ddf_4f050488-b116-4d34-b408-283d71713251.html,,,,,, Thionyl dichloride,7719-09-7,"Oral: LD50 = 324 mg/kg bw for rats (male/female); Dermal: Waiving, no test performed, substance is classified as higly corrosive according to Directive 67/548/EEC, Annex I; Inhalation: LC50 = 2717 mg/m³ air for rats (male/female) after 4 h inhalation ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7efb2fb-89a2-46b9-865e-b44fed788244/documents/IUC5-26af5cd0-5f50-4c15-b0ee-f8cbbb6a70e3_4f050488-b116-4d34-b408-283d71713251.html,,,,,, Thionyl dichloride,7719-09-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7efb2fb-89a2-46b9-865e-b44fed788244/documents/IUC5-26af5cd0-5f50-4c15-b0ee-f8cbbb6a70e3_4f050488-b116-4d34-b408-283d71713251.html,,oral,LD50,324 mg/kg bw,adverse effect observed, Thionyl dichloride,7719-09-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7efb2fb-89a2-46b9-865e-b44fed788244/documents/IUC5-26af5cd0-5f50-4c15-b0ee-f8cbbb6a70e3_4f050488-b116-4d34-b408-283d71713251.html,,inhalation,LC50,"2,717 mg/m3",adverse effect observed, "Thiophene, tetrahydro-, 1,1-dioxide, 3-(C9-11-isoalkyloxy) derivs., C10-rich",398141-87-2," ORAL NOEL = 100 mg/kg bw/day, NOAEL = 100 mg/kg bw/day; study performed in line with OECD Guideline 407; Morse (2004). NOAEL = 175 mg/kg bw/day male and female; study performed in line with OECD 421; Knapp (2005). NOAEL relevant for human risk assessment is considered to be 500 mg/kg/day, the highest dosage level tested for both sexes of rats; study performed in line with OECD 408; Haas (2017). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2d61c0f-358f-43e3-aef6-eda3b6d8e246/documents/IUC5-96e77105-1334-44b2-84ff-c20ca1ff00c3_c049f0cb-ea6e-4e3a-958c-1760f59ff3c9.html,,,,,, "Thiophene, tetrahydro-, 1,1-dioxide, 3-(C9-11-isoalkyloxy) derivs., C10-rich",398141-87-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d2d61c0f-358f-43e3-aef6-eda3b6d8e246/documents/IUC5-96e77105-1334-44b2-84ff-c20ca1ff00c3_c049f0cb-ea6e-4e3a-958c-1760f59ff3c9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,175 mg/kg bw/day,,rat "Thiophene, tetrahydro-, 1,1-dioxide, 3-(C9-11-isoalkyloxy) derivs., C10-rich",398141-87-2,"ORALLD50 >10 mL/kg (> 10,267 mg/kg); study performed in line with US 16 CFR 1500.3 Federal Hazardous Substances Act; Gabriel (1975)DERMALLD50 >4000 <8000 mg/kg bw; study performed in line with US 16 CFR 1500.3 Federal Hazardous Substances Act; Harris (1975) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2d61c0f-358f-43e3-aef6-eda3b6d8e246/documents/IUC5-7b0b49cc-785c-4ed9-9d28-c41da87528b3_c049f0cb-ea6e-4e3a-958c-1760f59ff3c9.html,,,,,, Thiophosphoryl trichloride,3982-91-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The study from Colosi-Esca (1984) has methodological deficiencies and is insufficient reported. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66916aec-30d7-4952-854e-3e3a72845f24/documents/IUC5-f1453b4f-8048-42e0-aac1-9ec8f35f00de_412c6b65-3c51-495d-8809-43c2524ee1e3.html,,,,,, Thiophosphoryl trichloride,3982-91-0,"The LC50 (rat, 4h): 140 mg/m³The LD50 (rat, oral) 750 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66916aec-30d7-4952-854e-3e3a72845f24/documents/IUC5-784a01c8-d959-4ff4-87a5-9eeef9ef7ac9_412c6b65-3c51-495d-8809-43c2524ee1e3.html,,,,,, Thiophosphoryl trichloride,3982-91-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66916aec-30d7-4952-854e-3e3a72845f24/documents/IUC5-784a01c8-d959-4ff4-87a5-9eeef9ef7ac9_412c6b65-3c51-495d-8809-43c2524ee1e3.html,,oral,LD50,750 mg/kg bw,adverse effect observed, Thiophosphoryl trichloride,3982-91-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66916aec-30d7-4952-854e-3e3a72845f24/documents/IUC5-784a01c8-d959-4ff4-87a5-9eeef9ef7ac9_412c6b65-3c51-495d-8809-43c2524ee1e3.html,,inhalation,LC50,140 mg/m3,adverse effect observed, Thiosemicarbazide,79-19-6," Weight of evidence: Thiosemicarbazide by oral route to rats produced some changes in body weight and clinical signs of tested animals. The NOAEL was judged to be 2 mg/kg/day for males and females, NOEL of 0.4 mg/kg/day for males and NOEL of 2 mg/kg/bw for female in the tested concentration 0, 0.4, 2 and 10 mg/kg. For the tested concentration 0, 0.2,1 and 5 mg/kg, thiosemicarbazide produced  some changes in body and organ weight,thymus size and small clinical signs of tested animals. The NOAEL was judged to be 5 mg/kg/day for females,and 1mg/kg for males and the NOEL of 1 mg/kg/day for males and 5 mg/kg for females. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47bc2f48-c477-45e2-883d-81f546ca05c7/documents/ef789ec0-d66f-4026-9548-19974c5d1cf7_58821044-d3f8-4785-b7b1-4e355771e0d3.html,,,,,, Thiosemicarbazide,79-19-6," Weight of evidence: According the several handbooks and the well documented publications the test item has the following LD values: LD50 oral value of 9.2 mg/kg/ for rats (Enviromental data on Organic chemicals) and 13 mg/kg/bw for rats (Merck Index). The ALD of 94 mg/kg for deer mouse (Archives of Environmental Contamination and Toxicology) and LD100 of 20 mg/kg for mice (Sage Journal). The LD50 of 10 mg/kg/bw for dog, LD50 of 20 mg/kg/bw for cat and LD50 of 94 mg/kg/bw for mouse were evaluated according the handbook of Envirnmental data on organic chemicals. In the summary, the different LD50 values are between 9.2 - 20 mg/kg for species (rats,mouse, cat and dog). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47bc2f48-c477-45e2-883d-81f546ca05c7/documents/af52ba97-1a49-4a2e-a99a-19dd8beb158b_58821044-d3f8-4785-b7b1-4e355771e0d3.html,,,,,, Thiosemicarbazide,79-19-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47bc2f48-c477-45e2-883d-81f546ca05c7/documents/af52ba97-1a49-4a2e-a99a-19dd8beb158b_58821044-d3f8-4785-b7b1-4e355771e0d3.html,,oral,LD50,9.2 mg/kg bw,adverse effect observed, Thuj-4(10)-ene,3387-41-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/76e8dc87-003e-4007-bf2d-f4f110ccc124/documents/c1d227a8-39e1-433e-be67-37c1b976b536_dfe03bef-aace-4cd1-8b64-7348ba7e0959.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Tiapride,51012-32-9, The substance is predicted to have a LD50 of ca. 717 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/faa1e53a-3cd1-402f-ba95-0072610f35b1/documents/3ecb4032-690e-4a7a-8c60-c54070bd3b7b_75d36e6a-b142-4b04-b249-a4eb15acb33c.html,,,,,, Tiapride,51012-32-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/faa1e53a-3cd1-402f-ba95-0072610f35b1/documents/3ecb4032-690e-4a7a-8c60-c54070bd3b7b_75d36e6a-b142-4b04-b249-a4eb15acb33c.html,,oral,LD50,717 mg/kg bw,, Tin antimony grey cassiterite,68187-54-2, Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 423; GLP compliant) Acute inhalation toxicity: LC50 > 5.07 mg/L air (analytical) (OECD 436; GLP compliant) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ae8acf0-f570-4bbd-b2d1-a3198face492/documents/IUC5-794d98f8-7f8d-4685-b1a5-1b59f2a81e61_64399dcf-58e8-4ec8-bcd7-b1ff34acc901.html,,,,,, Tin bis(2-ethylhexanoate),301-10-0,"Subchronic repeated-dose (90 day) studies are available for the two hydrolysis products of tin bis(2 -ethylhexanoate), stannous chloride and ethylhexanoic acid. These studies reported a decrease in body weight gain at higher doses for both materials and mild effects on liver and kidney weights and liver histopathology for EHA only. The liver effects for EHA were considered to be adaptive in nature and not toxic effects. The NOAEL for stannous chloride was 175.7 mg/kg bw/day based on decreased body weight, which was only observed in males. In females no effects were observed up to the highest dose tested (669.5 mg/kg bw/day). The NOAEL for EHA was 303 mg/kg/day in males and 360 mg/kg bw/day in females based on growth retardation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60b51e6b-5a77-496c-8194-c63d0d321dc0/documents/IUC5-a9b5d6d4-46a8-46cc-97df-96c0ceb6d3c9_89d6c8f7-9cfd-47d4-a2b5-e394c50d1739.html,,,,,, Tin bis(2-ethylhexanoate),301-10-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/60b51e6b-5a77-496c-8194-c63d0d321dc0/documents/IUC5-a9b5d6d4-46a8-46cc-97df-96c0ceb6d3c9_89d6c8f7-9cfd-47d4-a2b5-e394c50d1739.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,175.7 mg/kg bw/day,,rat Tin bis(2-ethylhexanoate),301-10-0,Acute oral LD50: 5870 mg/kg bwAcute dermal LD50: >2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60b51e6b-5a77-496c-8194-c63d0d321dc0/documents/IUC5-f945ae08-f707-4fa9-a3c8-14056a36cc9e_89d6c8f7-9cfd-47d4-a2b5-e394c50d1739.html,,,,,, Tin bis(2-ethylhexanoate),301-10-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60b51e6b-5a77-496c-8194-c63d0d321dc0/documents/IUC5-f945ae08-f707-4fa9-a3c8-14056a36cc9e_89d6c8f7-9cfd-47d4-a2b5-e394c50d1739.html,,oral,LD50,"5,870 mg/kg bw",no adverse effect observed, Tin bis(2-ethylhexanoate),301-10-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/60b51e6b-5a77-496c-8194-c63d0d321dc0/documents/IUC5-f945ae08-f707-4fa9-a3c8-14056a36cc9e_89d6c8f7-9cfd-47d4-a2b5-e394c50d1739.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tin bis(tetrafluoroborate),13814-97-6,Tin(II) bis(methanesulfonate):Oral NOEL 50 mg/kg/day over 90 days.Potassium tetrafluoroborate: A NOAEL of 40 mg/kg bw/day was established in a reproduction/developmental toxicity screening test and a NOAEL of 74 mg/m3 was established in a 28-day inhalation study in rats for systemic effects. No local effects were observed at concentrations up to 225 mg/m3 in the 28-day inhalation study. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe2ed15b-ebbe-4da8-9e08-09338f842e1b/documents/IUC5-d1c9ec0d-bd6a-4f83-85ad-3c301a370ff3_0db7874e-218a-4850-ba7b-43b398fdef14.html,,,,,, Tin bis(tetrafluoroborate),13814-97-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fe2ed15b-ebbe-4da8-9e08-09338f842e1b/documents/IUC5-d1c9ec0d-bd6a-4f83-85ad-3c301a370ff3_0db7874e-218a-4850-ba7b-43b398fdef14.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,142 mg/kg bw/day,,rat Tin bis(tetrafluoroborate),13814-97-6,"Divers studies on acute oral toxicity performed either with tin bis(tetrafluoroborate) or with a structural analogue (i.e., tin(II) methanesulfonate, sodium tetrafluoroborate and tin dichloride) are available with LD50 values between 130 mg/kg bw. (Powers & Derelanko, 1985) and > 2000 m g/kg bw. (Chibanguza, 1986 and Anonymous, 1992). In a weight of evidence approach (see discussion below) it is discussed that the substance tin bis(tetrafluoroborate) should be labeled as harmful if swallowed (LD50 between 300 and 2000 mg/kg bw.).No study on acute inhalation toxicity are available. Since the substance is placed on the market as solution (50%) only and is not stable without the water additive, the vapour pressure of the aqueous solution is negligible and the exposure to aerosols, particles or droplets of an inhalable size is not foreseeable under the intended use, animal testing for this endpoint is not considered to be justified.A study for acute dermal toxicity performed with a structural analogue tin(II) bis(methanesulfonate) are available, resulting in a LD50 greater than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe2ed15b-ebbe-4da8-9e08-09338f842e1b/documents/IUC5-cd4918be-ee1f-400f-96c9-639678397f50_0db7874e-218a-4850-ba7b-43b398fdef14.html,,,,,, Tin bis(tetrafluoroborate),13814-97-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fe2ed15b-ebbe-4da8-9e08-09338f842e1b/documents/IUC5-cd4918be-ee1f-400f-96c9-639678397f50_0db7874e-218a-4850-ba7b-43b398fdef14.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Tin disulphide,1315-01-1,"In a dose escalation inhalation toxicity study with Tin disulfide, Wistar rats were exposed to a fixed target aerosol concentration of 5.0 mg/L for 1.5 hour, 3 hours and 6 hours for 3 days (phase 1). Based on the results, Wistar rats were exposed to 1.0 mg/L and 5 mg/L for 3 and 6 hours per day for a period of 5 days (Phase 2). In Phase 1 the MMAD was 2.90 micron (GSD: 1.95); in Phase 2 the MMAD ranged from 2.53-2.68 micron (GSD: 1.92-2.02).  Exposure to Tin disulphide did not cause any clinical signs or any treatment related effect in the body weight, necropsy, clinical pathology or histopathology. One female (1/3) died on day 2, without a clear cause of death, the relationship with chemical toxicity of the test item is equivocal. Lung weights appeared to be increased and residual test item (often in macrophages) was observed in the lungs and associated lymphatic system and in the upper airways. The MTC and the NOAEC are considered to be the High dose (5.0 mg/L) in this short term study.   In a 28-day dose range finding inhalation toxicity study with Tin disulfide, Wistar rats were exposed to the test atmosphere at target concentrations of 0.2, 1.0 and 5.0 mg/L.  The MMAD varied from 2.28 -2.8 µm  (GSD 1.92-2.10).  The absolute and relative (to body weights and brain weights) lung weights were significantly higher in test item exposed rats, with a dose dependent trend in both sexes. Decreased absolute and relative thymus weights were measured in High Dose males and decreased spleen weight (relative to BW) was observed in High Dose females. Test item-related yellow discolouration of all lobes of lungs and mediastinal lymph nodes was observed in all test item exposed animals. The enlargement of these organs was also observed. In the lavage fluid following bronchoalveolar lavage, the level of LDH showed statistically significant, dose dependent increase, total cell number also increased statistically significantly  In histopathology, test item-related changes were seen at all concentrations, the accumulation of the test item in the lungs, in the mediastinal lymph nodes and the degeneration of the olfactory epithelium in the rostral part of the nasal cavity was observed. As these changes might be expressed as more severe lung effects in the 90-day study (due to a longer study duration and a probably slow clearance), lower dose levels for the 90-day study are recommended based on the results of this DRF study.   In a key 90-day inhalation toxicity study in rats with Tin disulfide, 10 male and  10 female Wistar Hannover rats Crl:WI(Han) in each main group were treated by a 6 hour nose-only exposure to filtered air or three fixed aerosol concentrations (target concentrations of 0.02, 0.2 and 1.0 mg/L, as the Low, Mid and High Dose Concentration, respectively) for 5 days/week. The MMAD varied from 2.01-3.91 µm (GSD 2.01-2.05).  The main animals were sacrificed on the day following the last exposure on Day 91 (histopathology evaluation and BALF analysis were performed). Additionally, 5 females per group were treated and allowed to recover for 6 weeks and sacrificed on Day 132 (histopathology evaluation and BALF analysis were performed) and 15 males per group were treated and allowed to recover and sacrificed on Day 91, Day 132 (6-week recovery) and Day 174 (approximately 3-month recovery) for histopathology and/or lung burden evaluation. There were no significant changes outside the respiratory system. All the changes observed in the respiratory tract or associated lymph system were considered to be related to the presence of test item or normal physiological responses to the presence of dust. However, the High dose level involved a lung burden that was higher than the clearance systems could process, with little or no recovery of lung weights or of histological changes (although there was no evidence of any degeneration, inflammatory changes or progression after 13 weeks of recovery). In the Mid and Low dose groups, there was good evidence of progress towards a recovery. In conclusion, under the conditions of this study, the No Observed Effect Concentration (NOEC) for systemic effects was the High dose level of 1 mg/L. Local changes in the respiratory tract were seen in all groups treated with test item. Recovery was significant in the Low and Mid dose groups, hence the No Adverse Observed Effect Concentration (NOAEC, based on local effects) for the study was the Mid dose (0.2 mg/L).   A 90-day repeated dose oral gavage toxicity study in rats daily dosed with Tin sulfide at doses of 100, 300 and  1000 mg/kg bw per day resulted in a slight increase in food consumption, associated with slight increases in body weight and serum glucose concentrations in females dosed at 1000 mg/kg, as well as slight decreases in serum Na and Cl. Except for the above mentioned changes, Tin sulfide did not cause any other changes. Therefore Tin sulfide was considered safe and well tolerated up to the dose of 1000 mg/kg bw/day. The NOAEL was defined at 1000 mg/kg and the NOEL at 300 mg/kg.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): High (Klimisch 1) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32958baa-98f2-4f18-941f-9e384498f8b8/documents/8fe81985-0cb5-478e-92cb-c9eb60b32a94_e0f0b518-a6a0-4b04-b1c7-ae7ce2b92953.html,,,,,, Tin disulphide,1315-01-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32958baa-98f2-4f18-941f-9e384498f8b8/documents/8fe81985-0cb5-478e-92cb-c9eb60b32a94_e0f0b518-a6a0-4b04-b1c7-ae7ce2b92953.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tin disulphide,1315-01-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32958baa-98f2-4f18-941f-9e384498f8b8/documents/8fe81985-0cb5-478e-92cb-c9eb60b32a94_e0f0b518-a6a0-4b04-b1c7-ae7ce2b92953.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"1,000 mg/m3",,rat Tin disulphide,1315-01-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32958baa-98f2-4f18-941f-9e384498f8b8/documents/8fe81985-0cb5-478e-92cb-c9eb60b32a94_e0f0b518-a6a0-4b04-b1c7-ae7ce2b92953.html,Repeated dose toxicity – local effects,inhalation,NOAEC,200 mg/m3,adverse effect observed,rat Tin disulphide,1315-01-1,"Acute toxicity of Tin disulfide powder was tested in key studies according to standard methods for oral, inhalation and dermal toxicity in rats. Resulting LD50 values were > 2000 mg/kg bw for oral and dermal application and > 5 mg/L for inhalation (nose only) administration. Laboured respiration and respiratory rate increase were recorded in the inhalation study. Supporting studies based on read-across with Tin sulfide were available for oral, dermal and inhalation application, showing similar results. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): High (Klimisch 1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): High (Klimisch 1) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): High (Klimisch 1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32958baa-98f2-4f18-941f-9e384498f8b8/documents/920adb32-8672-4e7c-8d90-fa2c7adf721e_e0f0b518-a6a0-4b04-b1c7-ae7ce2b92953.html,,,,,, Tin disulphide,1315-01-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32958baa-98f2-4f18-941f-9e384498f8b8/documents/920adb32-8672-4e7c-8d90-fa2c7adf721e_e0f0b518-a6a0-4b04-b1c7-ae7ce2b92953.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tin disulphide,1315-01-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32958baa-98f2-4f18-941f-9e384498f8b8/documents/920adb32-8672-4e7c-8d90-fa2c7adf721e_e0f0b518-a6a0-4b04-b1c7-ae7ce2b92953.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tin disulphide,1315-01-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32958baa-98f2-4f18-941f-9e384498f8b8/documents/920adb32-8672-4e7c-8d90-fa2c7adf721e_e0f0b518-a6a0-4b04-b1c7-ae7ce2b92953.html,,inhalation,LC50,5.02 mg/m3,no adverse effect observed, Tin monoxide,21651-19-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e0eafbf-f0d8-4e1d-810a-47c2b1fdbff8/documents/IUC5-910fe2f3-2a81-4f04-a8f5-abe89840837d_85b9bfa8-6692-430d-94c8-9b8e647a91ec.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,9.19 ,, Tin monoxide,21651-19-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e0eafbf-f0d8-4e1d-810a-47c2b1fdbff8/documents/IUC5-910fe2f3-2a81-4f04-a8f5-abe89840837d_85b9bfa8-6692-430d-94c8-9b8e647a91ec.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,52.9 ,, Tin monoxide,21651-19-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6e0eafbf-f0d8-4e1d-810a-47c2b1fdbff8/documents/IUC5-910fe2f3-2a81-4f04-a8f5-abe89840837d_85b9bfa8-6692-430d-94c8-9b8e647a91ec.html,Repeated dose toxicity – local effects,inhalation,LOAEC,2.44 mg/m3,adverse effect observed,rat Tin monoxide,21651-19-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6e0eafbf-f0d8-4e1d-810a-47c2b1fdbff8/documents/IUC5-50e07ddc-e8be-406a-b025-6102d19cc00e_85b9bfa8-6692-430d-94c8-9b8e647a91ec.html,,oral,LD50,"1,392 mg/kg bw",adverse effect observed, "Tin(II,IV)-sulfide",12067-23-1, Oral exposure: Tin sulfide showed no effects considered as adverse in a subchronic toxicity study according to OECD guideline 409. The NOAEL was defined at 1000 mg/kg and the NOEL at 300 mg/kg. Based on this information it is considered that also ditin trisulfide reveals after oral application no subchronic toxic effects. The calculated NOAEL for ditin trisulfide is 1106 mg/kg bw/day.   ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/78ac4b48-3b18-4353-b3dc-dcb24d4f91dc/documents/750584b2-629a-4458-bebd-95728598b46c_49d74e24-f24b-442e-8a36-7dc46b52fd4e.html,,,,,, "Tin(II,IV)-sulfide",12067-23-1,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/78ac4b48-3b18-4353-b3dc-dcb24d4f91dc/documents/750584b2-629a-4458-bebd-95728598b46c_49d74e24-f24b-442e-8a36-7dc46b52fd4e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,106 mg/kg bw/day",,rat "Tin(II,IV)-sulfide",12067-23-1," Key GLP and guideline compliant studies on a structural analogous read-across substance tin sulfide and tin disulfide are availble for oral, inhalatoin and dermal toxicity testing. Alles studies showed values above limit dose, therefore ditin trisulfide shows no acute toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78ac4b48-3b18-4353-b3dc-dcb24d4f91dc/documents/cb33aba0-1527-48d4-8324-1120672a4afa_49d74e24-f24b-442e-8a36-7dc46b52fd4e.html,,,,,, Tin sulphate,7488-55-3," Repeated dose toxicity: via oral route OECD 408 conducted with the analogous substance Tin(II) chloride - Adverse effects on body weight and/or body weight gain in males, NOAEL considered 2500 ppm (equivalent to 175.7 mg/kg bw/day) for males and 6000 ppm for females (equivalent to 669.5 mg/kg bw/day) (Holalagoudar, 2021) Repeated dose toxicity: via inhalation route OECD 412 conducted with the analogous substance Tin(II) oxide - NOAEC was considered to be 9.19 μg/L (Walker, 2015) Repeated dose toxicity: via dermal route Due to the classification Skin Sens 1 intensive risk management measures are in place to avoid significant skin contact. Hence, a study via dermal route is not performed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6701abe5-453f-4a3b-ba80-f0fb9ab5e5b8/documents/IUC5-7965ebcf-74e3-4396-911f-8d1afaebc3e1_8f912889-513a-4651-8024-ae2599f2f462.html,,,,,, Tin sulphate,7488-55-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6701abe5-453f-4a3b-ba80-f0fb9ab5e5b8/documents/IUC5-7965ebcf-74e3-4396-911f-8d1afaebc3e1_8f912889-513a-4651-8024-ae2599f2f462.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,9.19 mg/m3,,rat Tin sulphate,7488-55-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6701abe5-453f-4a3b-ba80-f0fb9ab5e5b8/documents/IUC5-7965ebcf-74e3-4396-911f-8d1afaebc3e1_8f912889-513a-4651-8024-ae2599f2f462.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,175.7 mg/kg bw/day,,rat Tin sulphate,7488-55-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6701abe5-453f-4a3b-ba80-f0fb9ab5e5b8/documents/IUC5-7965ebcf-74e3-4396-911f-8d1afaebc3e1_8f912889-513a-4651-8024-ae2599f2f462.html,Repeated dose toxicity – local effects,inhalation,NOAEC,9.19 mg/m3,adverse effect observed,rat Tin sulphate,7488-55-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6701abe5-453f-4a3b-ba80-f0fb9ab5e5b8/documents/IUC5-1095fb13-5373-45f1-80e6-370b6b77be5b_8f912889-513a-4651-8024-ae2599f2f462.html,,oral,LD50,"2,207 mg/kg bw",, Tin sulphate,7488-55-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6701abe5-453f-4a3b-ba80-f0fb9ab5e5b8/documents/IUC5-1095fb13-5373-45f1-80e6-370b6b77be5b_8f912889-513a-4651-8024-ae2599f2f462.html,,inhalation,LC50,2 mg/L,adverse effect observed, Tin sulphide,1314-95-0,"Oral exposure: Tin sulfide showed no effects considered as adverse in a subchronic toxicity study according to OECD guideline 408. The NOAEL was defined at 1000 mg/kg and the NOEL at 300 mg/kg.Inhalation exposure: In accordance with column 2 of REACH Regulation EC (No) 1907/2006 Annex IX, the test repeated dose toxicity after inhalation (section 8.6) does not need to be conducted as a repeated dose toxicity study for oral application is available. Due to the identified uses an inhalative exposure is not expected. Therefore the test is not required (annex IX column 2, 8.6.2). Dermal exposure: In accordance with column 2 of REACH Regulation EC (No) 1907/2006 Annex IX, the test repeated dose toxicity after dermal application (section 8.6) does not need to be conducted a repeated dose toxicity study for oral application is available. In addition, the acute dermal study showed also no toxicity. Therefore no long-term dermal toxicity study is required (annex IX column 2, 8.6.2). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP and guideline compliant study on tin sulfide ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c57c33ab-9979-4444-8f49-0f0e2a8e5e9c/documents/de549524-84b4-4a51-a849-01dae80390c3_f38ad071-d4c6-4aed-a061-759cdee657ca.html,,,,,, Tin sulphide,1314-95-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c57c33ab-9979-4444-8f49-0f0e2a8e5e9c/documents/de549524-84b4-4a51-a849-01dae80390c3_f38ad071-d4c6-4aed-a061-759cdee657ca.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tin sulphide,1314-95-0,No toxicity has been seen in acute oral and dermal toxicity studies with tin sulfide. No death occurred in an acute inhalation toxicity study with tin sulfide but test item-related brown discoloration of the lungs and enlarged lung-associated lymph nodes and in some animals slight body weight loss during the first three days of the observation period was noted. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c57c33ab-9979-4444-8f49-0f0e2a8e5e9c/documents/23b90275-32ab-447d-b5ec-4679f24f2307_f38ad071-d4c6-4aed-a061-759cdee657ca.html,,,,,, Tin sulphide,1314-95-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c57c33ab-9979-4444-8f49-0f0e2a8e5e9c/documents/23b90275-32ab-447d-b5ec-4679f24f2307_f38ad071-d4c6-4aed-a061-759cdee657ca.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tin sulphide,1314-95-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c57c33ab-9979-4444-8f49-0f0e2a8e5e9c/documents/23b90275-32ab-447d-b5ec-4679f24f2307_f38ad071-d4c6-4aed-a061-759cdee657ca.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tin sulphide,1314-95-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c57c33ab-9979-4444-8f49-0f0e2a8e5e9c/documents/23b90275-32ab-447d-b5ec-4679f24f2307_f38ad071-d4c6-4aed-a061-759cdee657ca.html,,inhalation,LC50,"5,030 mg/m3",adverse effect observed, Tin Titanium Zinc kegginite B,923954-49-8," Repeated dose toxicity: - oral: NOAEL = 1000 mg/kg bw/d (OECD 407) In accordance with Annex IX, section 8.6.2, column 2, a subchronic toxicity study has been waived. For further information please refer to the respective study record. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/42225f21-6809-4fb5-83e3-33d10fb291cb/documents/81c14ca7-b769-4eb4-ab78-c4e5ff859eec_a4a62fea-467f-45c4-b826-d56063cc4fc5.html,,,,,, Tin Titanium Zinc kegginite B,923954-49-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/42225f21-6809-4fb5-83e3-33d10fb291cb/documents/81c14ca7-b769-4eb4-ab78-c4e5ff859eec_a4a62fea-467f-45c4-b826-d56063cc4fc5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tin Titanium Zinc kegginite B,923954-49-8,Acute toxicity:- oral: LD50 >5000 mg/kg bw (OECD 423)- inhalative: LC50 > 5.7 mg/L air (OECD 403) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42225f21-6809-4fb5-83e3-33d10fb291cb/documents/6ad1c3e5-b138-4858-a0ea-84984cab91e4_a4a62fea-467f-45c4-b826-d56063cc4fc5.html,,,,,, Tin Titanium Zinc kegginite B,923954-49-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42225f21-6809-4fb5-83e3-33d10fb291cb/documents/6ad1c3e5-b138-4858-a0ea-84984cab91e4_a4a62fea-467f-45c4-b826-d56063cc4fc5.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Tin Titanium Zinc kegginite B,923954-49-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/42225f21-6809-4fb5-83e3-33d10fb291cb/documents/6ad1c3e5-b138-4858-a0ea-84984cab91e4_a4a62fea-467f-45c4-b826-d56063cc4fc5.html,,inhalation,LC50,"5,700 mg/m3",no adverse effect observed, Zinc stannate,12036-37-2," Repeated dose toxicity: oralIn a study designed to comply with Method B7, Annex V of the EEC Commission Directive 84/449/EEC and follows the recommendations of the OECD Guidelines for Testing of Chemicals No. 407 ""Repeated Dose Oral Toxicity - Rodent 28-day or 14-day study"", oral administration of the test material, Zinc Hydroxystannate, at dose levels of up to 1233 mg/kg/day for twenty-eight consecutive days in the rat, produced no treatment-related changes in the parameters measured.1233 mg/kg/day was therefore considered to be the NOEL. Repeated dose toxicity: oralIn accordance with Section 8.6.2, Column 2 of REACH Annex IX, it is considered appropriate to omit the subchronic toxicity study (90-day) as the substance is unreactive, insoluble and there is no evidence of toxicity in a 28 day ""limit test"". Repeated dose toxicity: inhalationIn accordance with Section 8.6.2, Column 2 of REACH Annex IX, it is considered appropriate to omit the subchronic toxicity study (90-day) as the substance displayed no signs of toxicity in an acute toxicity test via the inhalation route at the highest achievable concentration and has been shown to be unreactive, insoluble and there is no evidence of toxicity in a 28 day ""limit test"" via the oral route which is considered to adequately address the short-term repeated dose toxicity endpoint. Repeated dose toxicity: dermalIn accordance with Section 8.6.2, Column 2 of REACH Annex IX it is considered appropriate to omit the subchronic toxicity study (90-day) via the dermal route as the substance has been shown to be unreactive and insoluble. The substance's physicochemical and toxicological properties do not suggest that there is potential for a significant rate of absorption through the skin and there is no evidence of toxicity in a 28 day ""limit test"" via the oral route. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d70069c-1c59-458a-b55c-d76df0e59c88/documents/IUC5-c8463994-e855-45f5-9b35-3972b374b241_b0569410-10bd-47c2-bc2e-7d55d75ee9bb.html,,,,,, Zinc stannate,12036-37-2," Acute Oral Toxicity The key study was conducted in accordance with GLP and the standardised guidelines OECD Guidelines for Testing of Chemicals (1981) No. 401 ""Acute Oral Toxicity"" referenced as method B1 in Annex V of EEC Commission Directive 84/449/EEC. The acute oral median lethal dose (LD50) of the test material, Zinc Hydroxystannate, in the Sprague-Dawley CFY strain rat was found to be greater than 5000 mg/kg bodyweight.   Acute Inhalation Toxicity  The key study was conducted in accordance with GLP and the standardised guidelines OECD Guidelines for Testing of Chemicals (1981) No. 403 ""Acute Inhalation Toxicity"" referenced as method B2 in Annex V of EEC Commission Directive 84/449/EEC. The acute inhalation LC50 of the test material, Zinc Hydroxystannate, in the Sprague-Dawley CFY rat was greater than 4.35 mg/litre.    Acute Dermal Toxicity  In accordance with Section 8.5.3, Column 2 of REACH Annex VIII it is considered appropriate to omit the acute toxicity testing by the dermal route as the physicochemical and toxicological properties of the substance do not suggest potential for a significant rate of absorption through the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d70069c-1c59-458a-b55c-d76df0e59c88/documents/2d005fac-19ce-41e3-b5c5-82b46682b9ce_b0569410-10bd-47c2-bc2e-7d55d75ee9bb.html,,,,,, Tin(2+) neodecanoate,49556-16-3,"There are reliable two 90 d oral toxicity studies performed with neodecanoic acid (CAS no. 26896-20-8) and tin dichloride (CAS no. 7772-99-8), the anionic and cationic part of the registration substance, avalaible: 1. Subchronic oral toxicity study according to OECD 408 performed with neodecanoic acid (CAS no 6896-20-8), anionic part NOAEL: 700 mg/kg bw/d 2. Subchronic oral toxicity study according to NTP protocol performed with tin dichloride (CAS no 67772-99-8), cationic part NOAEL: 121 mg/kg bw/d   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): reliable with restriction ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/362a1d26-86fd-479c-84c3-3140348ac66b/documents/bb9b1450-367c-4c5c-9b3c-dd28bb0e4b28_f94d648a-eb81-40bd-9d81-2c08cf6b4ab4.html,,,,,, Tin(2+) neodecanoate,49556-16-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/362a1d26-86fd-479c-84c3-3140348ac66b/documents/bb9b1450-367c-4c5c-9b3c-dd28bb0e4b28_f94d648a-eb81-40bd-9d81-2c08cf6b4ab4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,121 mg/kg bw/day,,rat Tin(2+) neodecanoate,49556-16-3,"The LD50 of the available acute oral and dermal toxicity studies performed with the registration substance and its structural analogue were derived at greater than 2000 mg/kg bw.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): reliable without restriction Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): reliable without restriction ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/362a1d26-86fd-479c-84c3-3140348ac66b/documents/143c0613-acce-44ea-9268-bd45bb5ae540_f94d648a-eb81-40bd-9d81-2c08cf6b4ab4.html,,,,,, Tin(2+) neodecanoate,49556-16-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/362a1d26-86fd-479c-84c3-3140348ac66b/documents/143c0613-acce-44ea-9268-bd45bb5ae540_f94d648a-eb81-40bd-9d81-2c08cf6b4ab4.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Tin(2+) neodecanoate,49556-16-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/362a1d26-86fd-479c-84c3-3140348ac66b/documents/143c0613-acce-44ea-9268-bd45bb5ae540_f94d648a-eb81-40bd-9d81-2c08cf6b4ab4.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Tin(II) oxalate,814-94-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d837edac-a39d-488b-9aa7-407bc98e55ba/documents/e0a37f48-3a48-4b4e-9268-c4924b53390a_3f6d7cd0-696f-4c91-ae56-60e1b5a0f51f.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,9.19 ,, Tin(II) oxalate,814-94-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d837edac-a39d-488b-9aa7-407bc98e55ba/documents/e0a37f48-3a48-4b4e-9268-c4924b53390a_3f6d7cd0-696f-4c91-ae56-60e1b5a0f51f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,52.9 ,, Tin(II) oxalate,814-94-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d837edac-a39d-488b-9aa7-407bc98e55ba/documents/e0a37f48-3a48-4b4e-9268-c4924b53390a_3f6d7cd0-696f-4c91-ae56-60e1b5a0f51f.html,Repeated dose toxicity – local effects,inhalation,LOAEC,2.44 mg/m3,adverse effect observed,rat Tin(II) oxalate,814-94-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d837edac-a39d-488b-9aa7-407bc98e55ba/documents/IUC5-651b58c0-1c4c-4e96-9182-37278b982983_3f6d7cd0-696f-4c91-ae56-60e1b5a0f51f.html,,oral,LD50,"3,620 mg/kg bw",adverse effect observed, Tin(II) oxalate,814-94-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d837edac-a39d-488b-9aa7-407bc98e55ba/documents/IUC5-651b58c0-1c4c-4e96-9182-37278b982983_3f6d7cd0-696f-4c91-ae56-60e1b5a0f51f.html,,dermal,LD50,"2,001 mg/kg bw",adverse effect observed, Tin(II) oxalate,814-94-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d837edac-a39d-488b-9aa7-407bc98e55ba/documents/IUC5-651b58c0-1c4c-4e96-9182-37278b982983_3f6d7cd0-696f-4c91-ae56-60e1b5a0f51f.html,,inhalation,LC50,"2,000 mg/m3",adverse effect observed, "dioctylbis(pentane-2,4-dionato-O,O')tin",54068-28-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ea3efee-68ca-41e3-9a2d-986504c24857/documents/IUC5-dd043a87-4a20-4da8-b22b-fdec21ad241f_f7ec6777-17da-4f26-bacf-a05007ebdcfd.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,2.5 mg/kg bw/day,,rat "dioctylbis(pentane-2,4-dionato-O,O')tin",54068-28-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9ea3efee-68ca-41e3-9a2d-986504c24857/documents/IUC5-dd043a87-4a20-4da8-b22b-fdec21ad241f_f7ec6777-17da-4f26-bacf-a05007ebdcfd.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,100 mg/m3,,rat "dioctylbis(pentane-2,4-dionato-O,O')tin",54068-28-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9ea3efee-68ca-41e3-9a2d-986504c24857/documents/IUC5-0ec9fb24-75e2-43ae-96d9-a689d857b551_f7ec6777-17da-4f26-bacf-a05007ebdcfd.html,,oral,LD50,"2,500 mg/kg bw",adverse effect observed, "Tin, melting residues",84696-55-9,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1344b378-e2ec-4ead-bc72-89edbaf069a0/documents/IUC5-c301241a-7197-4018-bdfc-6a8d26466c48_7d6a809a-cbd1-48e7-b46e-fd7449ac8511.html,,,,,, "Tin, melting residues",84696-55-9,The acute toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1344b378-e2ec-4ead-bc72-89edbaf069a0/documents/IUC5-ac1f8d69-c1e8-48bd-8653-2b0455c95e3c_7d6a809a-cbd1-48e7-b46e-fd7449ac8511.html,,,,,, Titanium,7440-32-6,"Titanium dioxide did not show adverse effects in a chronic oral repeated dose toxicity study in rats with a NOAEL of 3500mg/kg bw/day.Titanium dioxide is not absorbed to any relevant extent through human skin, thus no toxic effects can be expected via the dermal route of exposure.Titanium it not inhalable at any relevant extent, thus conduct of repeated dose toxicity studies via the inhalation route is considered dispensable. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b59e50cc-9297-40d1-b87f-3a8257491738/documents/IUC5-3be7a996-20e9-4e25-acd1-c528d37810ce_090b7536-3dc5-475a-b2f5-9621c79660ca.html,,,,,, Titanium,7440-32-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b59e50cc-9297-40d1-b87f-3a8257491738/documents/IUC5-3be7a996-20e9-4e25-acd1-c528d37810ce_090b7536-3dc5-475a-b2f5-9621c79660ca.html,Chronic toxicity – systemic effects,oral,NOAEL,"3,500 mg/kg bw/day",,rat Titanium,7440-32-6,"Acute toxicity, oral:LD50 > 5000mg/kg bwAcute toxicity, dermal:Conduct of an acute dermal toxicity study is unjustified as physicochemical properties and dermal absorption data of the substance do not suggest a significant rate of absorption through the skin (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006).Acute toxicity, inhalation:The conduct of an acute inhalation toxicity study is unjustified as inhalation of the substance is considered negligible, based on the outcome of the dustiness testing according to the modified Heubach method, as reported under section particle size distribution (granulometry). Based on the results of the MPPD model only about 0.01 % or less of inhaled material is predicted to be deposited in the pulmonary region (PU), whereas the material deposited in the tracheobronchial (TB) and the extrathoracic region (Head) may be assumed to be cleared to the GI tract (i.e., by mucociliary escalation and subsequent swallowing) (cf. Annex VIII section 8.5 Column 2 of regulation (EC) 1907/2006). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b59e50cc-9297-40d1-b87f-3a8257491738/documents/IUC5-efd4d541-8284-4554-8357-dbd3ec3cc7ab_090b7536-3dc5-475a-b2f5-9621c79660ca.html,,,,,, "Titanium 2,2',2''-nitrilotrisethanolate",15879-01-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3b0bd8f-2e45-435f-a3fd-a12dbf326c5d/documents/3e851a50-6683-4438-9e0c-078bb2923146_a3a9f64b-0da1-434f-96bb-a3d04a57f1db.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,500 mg/m3,,rat "Titanium 2,2',2''-nitrilotrisethanolate",15879-01-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3b0bd8f-2e45-435f-a3fd-a12dbf326c5d/documents/3e851a50-6683-4438-9e0c-078bb2923146_a3a9f64b-0da1-434f-96bb-a3d04a57f1db.html,Repeated dose toxicity – local effects,inhalation,LOAEC,200 mg/m3,adverse effect observed,rat "Titanium 2,2',2''-nitrilotrisethanolate",15879-01-3, Oral: LD50 (rat) > 3488 mg kg bw/day Inhalation: no data available Dermal: no data available ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3b0bd8f-2e45-435f-a3fd-a12dbf326c5d/documents/65f8816c-e4bc-4874-85d0-7321b795a7c4_a3a9f64b-0da1-434f-96bb-a3d04a57f1db.html,,,,,, "Titanium 2,2',2''-nitrilotrisethanolate",15879-01-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3b0bd8f-2e45-435f-a3fd-a12dbf326c5d/documents/65f8816c-e4bc-4874-85d0-7321b795a7c4_a3a9f64b-0da1-434f-96bb-a3d04a57f1db.html,,oral,LD50,"3,488 mg/kg bw",no adverse effect observed, Titanium carbide,12070-08-5," Bioelution data for TiC support read-across between TiO2 and TiC. Details are given in the read-across report attached to section 13. Titanium dioxide did not show adverse effects in a chronic oral repeated dose toxicity study in mice and rats, with a NOAEL of 50,000 ppm (equivalent to 6,500 mg/kg bw/day in mice and 3,500 mg/kg bw/day in rats). The results from the bioelution tests with TiC together with the practical insolubility of the test material in a transformation/dissolution test show that no to verly low bioavailability via the inhalation and dermal route can be expected. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/205aec61-58e3-4199-9bf1-bb4d610ef687/documents/IUC5-2b267ca0-331e-43fe-b775-d5992424b2a5_d9d01ced-5808-4948-92a2-0d468f5051e9.html,,,,,, Titanium carbide,12070-08-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/205aec61-58e3-4199-9bf1-bb4d610ef687/documents/IUC5-2b267ca0-331e-43fe-b775-d5992424b2a5_d9d01ced-5808-4948-92a2-0d468f5051e9.html,Chronic toxicity – systemic effects,oral,NOAEL,"3,500 mg/kg bw/day",,rat Titanium carbide,12070-08-5," The results from a bioelution assay demonstrated very low titanium release from titanium carbide in simulated gastric fluid. Therefore, very low bioavailability can be expected via the oral route. In a read-across study, titanium dioxide did not show adverse effects after chronic oral repeated dose exposure in mice and rats. In addition, the results from the bioelution tests with TiC together with the practical insolubility of the test material in a transformation/dissolution test lead to the conclusion that no to very low bioavailability can be expected via the inhalation and dermal route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/205aec61-58e3-4199-9bf1-bb4d610ef687/documents/IUC5-98097f44-b658-489a-be4a-c731e81bba66_d9d01ced-5808-4948-92a2-0d468f5051e9.html,,,,,, Titanium diboride,12045-63-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/239a30b0-616e-436f-accb-823930ba1a4f/documents/IUC5-aa4058a3-0f2c-4943-9922-ba5f01a4c528_6d02d631-7490-4962-a7df-b689d21fbe48.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Titanium diboride,12045-63-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/239a30b0-616e-436f-accb-823930ba1a4f/documents/IUC5-aa4058a3-0f2c-4943-9922-ba5f01a4c528_6d02d631-7490-4962-a7df-b689d21fbe48.html,,inhalation,LC50,> 5.05 mg/L,no adverse effect observed, Titanium oxide sulphate,13825-74-6,"According to column 2 in the table given in REACH Annex IX, studies on repeated dose toxicity need not to be conducted if a substance undergoes immediate disintegration and there are sufficient data on the cleavage products (both for systemic effects and effects at the site of uptake). This deems to be the case as target chemical titanium oxide sulphate hydrolyses easily when in contact with wet material at around the environmentally and physiologically relevant pH range. Repeated dose toxicity studies on the final hydrolysis product titanium dioxide reveal that the substance needs not to be classified for repeated dose toxicity. Concerning the other final hydrolysis product sulphuric acid, its corrosiveness is not of relevance in this case, as the acidic effect is not to be considered as a true toxic effect. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e4095665-b03f-432d-ae03-be03a2afa29a/documents/IUC5-549fa116-f256-425f-85b2-0ba35810844b_29dc58b5-830e-464d-9ee4-d5bddbb120d7.html,,,,,, Titanium oxide sulphate,13825-74-6,An acute oral toxicity study was being conducted producing a LD50 > 2000 mg/kg bw . The other acute toxicity studies were being waived as target chemical is known to be corrosive. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e4095665-b03f-432d-ae03-be03a2afa29a/documents/IUC5-ee23e83a-89ca-40dc-9e36-e4f02f063359_29dc58b5-830e-464d-9ee4-d5bddbb120d7.html,,,,,, Titanium tetrachloride,7550-45-0," Oral: No data available, oral exposure of the general public via the environment is not possible due to the fast hydrolysis of TiCl4 to TiO2 and HCl. Further, titanium tetrachloride is exclusively used in industrial settings with strict risk management measures in place. Dermal: No data available. Due to the corrosive properties of the substance, effective risk management measures are in place protecting also against long-term effects. Inhaltion: Two year inhalation study in rat (vapour): the Low Observed Effect Concentration (LOAEC) for local irritation of the airways was 0.1 mg/m³. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/384e106e-adb1-4130-8971-be49caeacbd8/documents/IUC5-4292b35f-712f-4815-808a-30395f54fac3_890f291a-dcd2-4b46-8627-177fa9997a84.html,,,,,, Titanium tetrachloride,7550-45-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/384e106e-adb1-4130-8971-be49caeacbd8/documents/IUC5-4292b35f-712f-4815-808a-30395f54fac3_890f291a-dcd2-4b46-8627-177fa9997a84.html,Repeated dose toxicity – local effects,inhalation,LOAEC,0.1 mg/m3,adverse effect observed,rat Titanium tetrachloride,7550-45-0, Oral toxicity: The study does not need to be conducted because the substance is classified as corrosive to the skin. Dermal toxicity: The study does not need to be conducted because the substance is classified as corrosive to the skin. Inhalation toxicity: A LC50 of 460 mg/m³ (4h exposure) was determined for the rat in a reliable study (KEY Acute toxicity: inhalation.7.2.2.001 Kelly 1980) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/384e106e-adb1-4130-8971-be49caeacbd8/documents/IUC5-850a1079-bb91-4064-a079-d7dee5981537_890f291a-dcd2-4b46-8627-177fa9997a84.html,,,,,, Titanium tetrachloride,7550-45-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/384e106e-adb1-4130-8971-be49caeacbd8/documents/IUC5-850a1079-bb91-4064-a079-d7dee5981537_890f291a-dcd2-4b46-8627-177fa9997a84.html,,inhalation,LC50,460 mg/m3,adverse effect observed, Titanium tetraisopropanolate,546-68-9,"Repeated toxicity testing is not necessary since this substance undergoes immediate disintegration and there are sufficient data on cleavage product. The intrinsic properties of this substance, after repeated administration, is related to the main degradation product; isopropyl alcohol (IPA). The most appropriate exposure route is inhalation. NOAEC of 5000 ppm for isopropyl alcohol is used as key information (Burleigh-Flayer, H. D. et al. 1994). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9cb2020-0f05-4386-99a3-e3219f7d94a9/documents/5a7dc273-a703-41e6-b0b7-027954ed8ec5_e647de48-045a-40fd-827d-7c58204b1a2d.html,,,,,, Titanium tetraisopropanolate,546-68-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9cb2020-0f05-4386-99a3-e3219f7d94a9/documents/5a7dc273-a703-41e6-b0b7-027954ed8ec5_e647de48-045a-40fd-827d-7c58204b1a2d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"12,300 mg/m3",,rat Titanium tetraisopropanolate,546-68-9,Oral:The oral LD50 (rat; male) 7 500 mg/kg bwInhalation:The inhalation LC50 (rat; male) 7 780 mg/m3Dermal:There is no valid data available for acute dermal toxicity. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9cb2020-0f05-4386-99a3-e3219f7d94a9/documents/a8ee3377-eae7-4b6b-b31c-5617c3b7c7ac_e647de48-045a-40fd-827d-7c58204b1a2d.html,,,,,, Titanium tetraisopropanolate,546-68-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9cb2020-0f05-4386-99a3-e3219f7d94a9/documents/a8ee3377-eae7-4b6b-b31c-5617c3b7c7ac_e647de48-045a-40fd-827d-7c58204b1a2d.html,,oral,LD50,"7,500 mg/kg bw",adverse effect observed, Titanium tetraisopropanolate,546-68-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9cb2020-0f05-4386-99a3-e3219f7d94a9/documents/a8ee3377-eae7-4b6b-b31c-5617c3b7c7ac_e647de48-045a-40fd-827d-7c58204b1a2d.html,,inhalation,LC50,"7,780 mg/m3",adverse effect observed, Titanium tetrakis(2-ethylhexanolate),1070-10-6,Repeated toxicity testing was considered unnecessary since this substance undergoes immediate disintegration and there are sufficient data on cleavage product for the most relevant exposure route. The intrinsic properties of this substance after repeated administration are related to the main degradation product 2-ethylhexanol. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/583a793a-7b9e-434b-aa15-8c365b237fb8/documents/885c5a91-49a2-43c5-b502-a4208012d5a7_ab79b38d-6a99-4d44-b182-618c1dde1421.html,,,,,, Titanium tetrakis(2-ethylhexanolate),1070-10-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/583a793a-7b9e-434b-aa15-8c365b237fb8/documents/885c5a91-49a2-43c5-b502-a4208012d5a7_ab79b38d-6a99-4d44-b182-618c1dde1421.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Titanium tetrakis(2-ethylhexanolate),1070-10-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/583a793a-7b9e-434b-aa15-8c365b237fb8/documents/885c5a91-49a2-43c5-b502-a4208012d5a7_ab79b38d-6a99-4d44-b182-618c1dde1421.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,638 mg/m3,,rat Titanium tetrakis(2-ethylhexanolate),1070-10-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/583a793a-7b9e-434b-aa15-8c365b237fb8/documents/885c5a91-49a2-43c5-b502-a4208012d5a7_ab79b38d-6a99-4d44-b182-618c1dde1421.html,Repeated dose toxicity – local effects,inhalation,NOAEC,638 mg/m3,no adverse effect observed,rat Titanium tetrakis(2-ethylhexanolate),1070-10-6,"Oral:The oral LD50 (rat; male) is 7500 mg/kg bwThe oral LD50 (rat; male) for 2-ethylhexanol, the degradation product, is 3 290 mg/kg bwInhalation:There is no valid data available for acute inhalation toxicity for the target substance.The LC50 (rat; male, female) for 2-ethylhexanol, the degradation product, is > 1.4 mg/l (vapor saturation concentration)Dermal:There is no valid data available for acute oral toxicity for the target substance.The oral LD50 (rat; male, female) for the 2-ethylhexanol, the degradation product, is > 3 000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/583a793a-7b9e-434b-aa15-8c365b237fb8/documents/d0343531-47f1-47c9-a84c-cdb76ac8fca3_ab79b38d-6a99-4d44-b182-618c1dde1421.html,,,,,, Titanium tetrakis(2-ethylhexanolate),1070-10-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/583a793a-7b9e-434b-aa15-8c365b237fb8/documents/d0343531-47f1-47c9-a84c-cdb76ac8fca3_ab79b38d-6a99-4d44-b182-618c1dde1421.html,,oral,LD50,"3,290 mg/kg bw",no adverse effect observed, Titanium tetrakis(2-ethylhexanolate),1070-10-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/583a793a-7b9e-434b-aa15-8c365b237fb8/documents/d0343531-47f1-47c9-a84c-cdb76ac8fca3_ab79b38d-6a99-4d44-b182-618c1dde1421.html,,dermal,LD50,"3,000 mg/kg bw",no adverse effect observed, Titanium tetrakis(dimethylammonium),3275-24-9," Titanium tetrakic(dimethylammonium) is an organometalic liquid with an pH > 11. The substance is classified as corrosive. Additionally, titanium tetrakic(dimethylammonium) can only be handled in air-free environments. It is a flammable liquid and extremely unstable (see also chapter 1.2 or 5.2.1 or 13). Within seconds, it reacts violently in contact with moisture or water. The decomposition products are dimethylamine and titanium oxide. Dimethylamine is a highly flammable gas, but well soluble in water, highly basic, and corrosive to skin and eyes. In an acute inhalation toxicity study with dimethylamine (Steinhagen et al.), severe corrosive and necrotic effects were observed on eyes, skin, and mucous nasal membranes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/091a34df-346e-40f8-bf82-a3352574c779/documents/e3e13daa-8054-443e-8b07-42ae251e07fc_5c482bd7-666f-4791-b9a1-f1de44788c58.html,,,,,, Titanium tetrapropanolate,3087-37-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32b47f5f-4353-4ba6-af51-00600c8f8a39/documents/803e5d7f-d41b-4466-8910-96687429a4b4_6f81dab7-8087-45c8-a35d-ec5e58d7d7de.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,230 mg/m3",,rat Titanium tetrapropanolate,3087-37-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/32b47f5f-4353-4ba6-af51-00600c8f8a39/documents/803e5d7f-d41b-4466-8910-96687429a4b4_6f81dab7-8087-45c8-a35d-ec5e58d7d7de.html,Chronic toxicity – systemic effects,oral,NOAEL,"3,000 mg/kg bw/day",,rat Titanium tetrapropanolate,3087-37-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32b47f5f-4353-4ba6-af51-00600c8f8a39/documents/876e4041-c45b-41b0-8cc9-5c45ebe3280d_6f81dab7-8087-45c8-a35d-ec5e58d7d7de.html,,oral,LD50,"6,500 mg/kg bw",no adverse effect observed, Titanium tetrapropanolate,3087-37-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32b47f5f-4353-4ba6-af51-00600c8f8a39/documents/876e4041-c45b-41b0-8cc9-5c45ebe3280d_6f81dab7-8087-45c8-a35d-ec5e58d7d7de.html,,dermal,LD50,"4,032 mg/kg bw",no adverse effect observed, Titanium tetrapropanolate,3087-37-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/32b47f5f-4353-4ba6-af51-00600c8f8a39/documents/876e4041-c45b-41b0-8cc9-5c45ebe3280d_6f81dab7-8087-45c8-a35d-ec5e58d7d7de.html,,inhalation,LC50,"47,000 mg/m3",no adverse effect observed, "Titanium, (S) - lactate polyethylene glycol triisopropanolamine ammonium complexes",1072830-14-8,The substance has not been tested.The Disciminating dose levels are based on a surrogate read-across substance. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9bc933e-ac19-40f1-a7e5-9720a7d340cb/documents/IUC5-3b74d275-5930-4062-9058-22d62135b4af_359599c6-973f-4bfb-9709-60fc3df9540b.html,,,,,, "Titanium, (S) - lactate polyethylene glycol triisopropanolamine ammonium complexes",1072830-14-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a9bc933e-ac19-40f1-a7e5-9720a7d340cb/documents/IUC5-3b74d275-5930-4062-9058-22d62135b4af_359599c6-973f-4bfb-9709-60fc3df9540b.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Titanium, diethylene glycol ethylene glycol triisopropanolamine complexes",68784-47-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d402cc6b-cb90-4c5a-b411-3c23700b9867/documents/ce2ad751-dd87-4c6e-a0b3-f06fe0ea9aea_5a00856c-1f1c-44fe-8ee0-cded07f8b439.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, "Titanium, diethylene glycol propylene glycol triethanolamine complexes",68784-48-5,The substance has not been tested.The Disciminating dose levels are based on a surrogate read-across substance. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39ebf778-a0cb-4f23-9692-d1d5f58f0598/documents/IUC5-8460a4b6-6f43-4b47-8414-fdea16c62b01_a60220a1-f7ec-4cfb-9b2e-5716f86a9f3d.html,,,,,, "Titanium, diethylene glycol propylene glycol triethanolamine complexes",68784-48-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39ebf778-a0cb-4f23-9692-d1d5f58f0598/documents/IUC5-8460a4b6-6f43-4b47-8414-fdea16c62b01_a60220a1-f7ec-4cfb-9b2e-5716f86a9f3d.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, titanyl (IV) diascrobate,122958-50-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd35a3e0-e7a1-4cba-8036-2ea239981521/documents/2514400f-630f-49a1-9880-53a314593767_10474ed3-02a5-4447-b5ff-936fe6280fc3.html,Repeated dose toxicity – local effects,inhalation,NOAEC,33.9 mg/m3,no adverse effect observed, titanyl (IV) diascrobate,122958-50-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd35a3e0-e7a1-4cba-8036-2ea239981521/documents/796d1b82-2a10-49ce-b4fc-b0627d8adac9_10474ed3-02a5-4447-b5ff-936fe6280fc3.html,,oral,LD50,"1,410 mg/kg bw",adverse effect observed, titanyl (IV) diascrobate,122958-50-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd35a3e0-e7a1-4cba-8036-2ea239981521/documents/796d1b82-2a10-49ce-b4fc-b0627d8adac9_10474ed3-02a5-4447-b5ff-936fe6280fc3.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, titanyl (IV) diascrobate,122958-50-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd35a3e0-e7a1-4cba-8036-2ea239981521/documents/796d1b82-2a10-49ce-b4fc-b0627d8adac9_10474ed3-02a5-4447-b5ff-936fe6280fc3.html,,inhalation,LC50,"2,140 mg/m3",adverse effect observed, Toluene-4-sulphonohydrazide,1576-35-8,"Two studies are available evaluating the repeated dose toxicity (oral) of Toluene-4-sulphonohydrazide (TSH).  The repeated oral toxicity of TSH was evaluated in a 14-day toxicity study (OECD 407, version 1981) in rodents. TSH was administered to the rats by gavage at doses of 0 (vehicle, corn oil), 0.5, 5, and 50 mg/kg bw/day. A NOAEL < 50 mg/kg bw/day was established based on decreased GOT levels in both male and female rats at dose-level 50 mg/kg bw/day. However, effects on organ weight were observed in female (decreased spleen weight 0.5 mg/kg bw/day) and male (increased kidney weight 50 mg/kg bw/day), but not underlying pathology was confirmed by histopathology.   The repeated oral toxicity of TSH was evaluated in a combined repeated dose toxicity study with reproduction/developmental toxicity screening (OECD 422), in rodents (Wistar Han rats). The dose levels used in this study were 0, 4, 10 and 25 mg/kg/day, based on the results of a preliminary dose range finding study. Formulation analyses confirmed that formulations of test item in propylene glycol were prepared accurately and homogenously. The following parameters and endpoints relating to repeated dose toxicity were evaluated in this study: mortality/moribundity, clinical signs, functional observations, body weight and food consumption, clinical pathology, measurement of thyroid hormone T4 (F0-males), gross necropsy findings, organ weights and histopathologic examinations (estrous cycle was also measured in the study but are not relevant for repeated dose toxicity). The following parental toxicity was observed:   - At 4 mg/kg/day, a non-adverse lower mean alanine and aspartate aminotransferase activity was recorded. - At 10 mg/kg/day, adverse axonal degeneration of the sciatic nerve was observed for a single female, reduced grip strength of the fore- and hindlegs, occasional lower body weight at the end of post-coitum and during lactation, and lower alanine and aspartate aminotransferase activity and higher inorganic phosphate concentration. - At 25 mg/kg/day, adverse axonal degeneration of the sciatic nerve and skeletal muscle degeneration with atrophy, clinical signs consisting primarily of abnormal gait and abnormal posture of the hind legs, lower grip strength, delayed static righting reflex, lower motor activity, lower body weights, macroscopic caudal emaciation, lower alanine and aspartate aminotransferase, lower creatinine and higher inorganic phosphate concentration.   Non adverse morphologic alterations consisted of hepatocellular hypertrophy with correlating higher weight, and higher heart and kidney weights (both without microscopic correlate). Watery clear contents were recorded in the thoracic cavity of one female each at 10 and 25 mg/kg/day, which was considered not adverse.  In conclusion, based on the results of this combined 28-day repeated dose toxicity study with the reproduction/developmental toxicity screening test, the following No Observed Adverse Effect Levels (NOAEL) for Toluene-4-sulphonohydrazide was established:   Parental oral NOAEL for systemic effects: 4 mg/kg/day.    The NOAEL was based on axonal degeneration of the sciatic nerve in one female at 10 mg/kg/day, reduced grip strength of the fore- and hindlegs and lower alanine and aspartate aminotransferase activity. At 25 mg/kg/day, axonal degeneration of the sciatic nerve occurred with skeletal muscle degeneration and atrophy, with associated findings consisting of macroscopic caudal emaciation, abnormal gait, abnormal posture of the hind legs, lower body weight, reduced grip strength of the fore- and hindlegs, delayed static righting reflex, lower mean motor activity, lower alanine and aspartate aminotransferase activity and higher creatinine concentration.     Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Klimisch score 1. The study was performed in accordance with the OCED guideline 422 and according to GLP standard. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1444b2d8-144b-4e80-a876-7a680a4ed8b3/documents/634f8567-2673-4c10-801d-438509226d3e_3e034cb7-9179-4cec-87ed-dc85e8130987.html,,,,,, Toluene-4-sulphonohydrazide,1576-35-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1444b2d8-144b-4e80-a876-7a680a4ed8b3/documents/634f8567-2673-4c10-801d-438509226d3e_3e034cb7-9179-4cec-87ed-dc85e8130987.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,4 mg/kg bw/day,,rat Toluene-4-sulphonohydrazide,1576-35-8,"Acute toxicity, oral:  A LD50 value in rats of 283 mg/kg for p-TSH (T) is indicated in the ChemIDplus database, however, no specific reference is indicated and thus the validity of this information cannot be assessed.   No data is available for Toluene-4-sulphonohydrazide (TSH). However, QSAR prediction data (accessed on the 14-02-2022) shows that oral LD50 in rats and mice is 320 mg/kg bw/day and 1300 mg/kg bw/day, respectively. The predictions had a moderate prediction quality i.e., 0.59 and 0.52 for rats and mice, respectively. Furthermore, in an OECD guideline 489 (in vivo mammalian alkaline comet assay), Wister rats were treated by oral gavage with Toluene-4-sulphonohydrazide, mortality was observed at a dose of 250 mg/kg bw/day in males. Based on this TSH should be classified as Acute tox 3 H301.   Acute toxicity, dermal:  No data available for p-TSH. No data and low concern of acute toxicity via dermal exposure.   Acute toxicity, inhalation: No reliable experimental data is available for TSH. The presumed breakdown product of Toluene-4-sulphonohydrazid, hydrazine (CAS No. 302-01-2) shows an LC50 of 570ppm (0.759 mg/L); and has a harmonized classification for Acute Tox. 3, H331 (toxic if inhaled). Based on this TSH should be classified as Acute Tox. 3, H331.   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Based on prediction data from the Danish (Q)SAR database (accessed on 14-02-2022) as well as an OECD guideline 489 study. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Based on acute toxicity data for hydrazine, a presumed breakdown product of the target substance. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): No concerns for acute toxicity via dermal exposure ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1444b2d8-144b-4e80-a876-7a680a4ed8b3/documents/8073a69b-2544-4b8d-986d-4a6478e5a6a3_3e034cb7-9179-4cec-87ed-dc85e8130987.html,,,,,, Toluene-4-sulphonohydrazide,1576-35-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1444b2d8-144b-4e80-a876-7a680a4ed8b3/documents/8073a69b-2544-4b8d-986d-4a6478e5a6a3_3e034cb7-9179-4cec-87ed-dc85e8130987.html,,oral,LD50,> 250 mg/kg bw,adverse effect observed, Toluene-4-sulphonohydrazide,1576-35-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1444b2d8-144b-4e80-a876-7a680a4ed8b3/documents/8073a69b-2544-4b8d-986d-4a6478e5a6a3_3e034cb7-9179-4cec-87ed-dc85e8130987.html,,inhalation,LC50,570 ,no adverse effect observed, Toluenesulphonamide,1333-07-9,"Multiple studies available, including lifelong, that are adequate for use for hazard evaluation. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85fbe3a8-cfb2-4c0f-8a75-53607485b77f/documents/IUC5-6f8817a5-680b-4a7a-9746-8eac8e04c9d6_33141c4d-78fa-43be-84ba-39de67e84c7c.html,,,,,, Toluenesulphonamide,1333-07-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/85fbe3a8-cfb2-4c0f-8a75-53607485b77f/documents/IUC5-6f8817a5-680b-4a7a-9746-8eac8e04c9d6_33141c4d-78fa-43be-84ba-39de67e84c7c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat Toluenesulphonamide,1333-07-9,"The results are in-line with other available information on both the substance itself as for its components p-TSA and o-TSA. Substance is of low acute oral toxicity, not requiring classification. Also no classification is required for skin or eye irritation. Information on absorption indicates that o/p-TSA is rapidly and completely absorbed by oral route, en only 20% by dermal route. Further acute testing by dermal route is therefore scientifically unjustified. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85fbe3a8-cfb2-4c0f-8a75-53607485b77f/documents/IUC5-4d372130-aaf2-45b3-aa07-1ab6b8ccc991_33141c4d-78fa-43be-84ba-39de67e84c7c.html,,,,,, Toluenesulphonamide,1333-07-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85fbe3a8-cfb2-4c0f-8a75-53607485b77f/documents/IUC5-4d372130-aaf2-45b3-aa07-1ab6b8ccc991_33141c4d-78fa-43be-84ba-39de67e84c7c.html,,oral,LD50,"2,400 mg/kg bw",adverse effect observed, Toluenesulphonamide,1333-07-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/85fbe3a8-cfb2-4c0f-8a75-53607485b77f/documents/IUC5-4d372130-aaf2-45b3-aa07-1ab6b8ccc991_33141c4d-78fa-43be-84ba-39de67e84c7c.html,,dermal,discriminating dose,"7,500 mg/kg bw",no adverse effect observed, Tosyl chloride,98-59-9,"Testing in OECD 422 for up to 51 days (in females) resulted to limited local effects in the stomach following treatment of a corrosive substance, which recovered during a 14-day recovery period at the lowest dose level of 150 mg/kgbw/day. No systemic toxicity was observed at this level. The hydrolysis product p-toluenesulphonic acid is the substance that will become systemically available.  A GLP guideline study with p-toluenesulphonic acid reported no adverse effects to male and female rats exposed orally for 28 days. The highest dose was 500 mg/kg bw/day. Evaluations from cross-reading involving longer duration studies of 90-days do not result to lower NOAELs. Based on this information it is justified to take 150 mg/kg bw as NOAEL for systemic toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62befed7-00ff-4527-b662-fc57fd71bfdb/documents/IUC5-d1f4632b-e8fb-4bd6-b3a5-57b0b7e10953_7da0e9c7-c1d7-435a-b43e-f85b1e80178a.html,,,,,, Tosyl chloride,98-59-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62befed7-00ff-4527-b662-fc57fd71bfdb/documents/IUC5-d1f4632b-e8fb-4bd6-b3a5-57b0b7e10953_7da0e9c7-c1d7-435a-b43e-f85b1e80178a.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,150 mg/kg bw/day,,rat Tosyl chloride,98-59-9,Tosyl chloride is of low acute toxicity. Acute oral LD50 was established at 4680 mg/kgbw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62befed7-00ff-4527-b662-fc57fd71bfdb/documents/IUC5-8c7563a9-2c8f-4dfe-86b7-c5a466aef724_7da0e9c7-c1d7-435a-b43e-f85b1e80178a.html,,,,,, Tosyl chloride,98-59-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62befed7-00ff-4527-b662-fc57fd71bfdb/documents/IUC5-8c7563a9-2c8f-4dfe-86b7-c5a466aef724_7da0e9c7-c1d7-435a-b43e-f85b1e80178a.html,,oral,LD50,"4,680 mg/kg bw",adverse effect observed, Tosyl chloride,98-59-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62befed7-00ff-4527-b662-fc57fd71bfdb/documents/IUC5-8c7563a9-2c8f-4dfe-86b7-c5a466aef724_7da0e9c7-c1d7-435a-b43e-f85b1e80178a.html,,dermal,discriminating dose,"5,010 mg/kg bw",adverse effect observed, Tramadol,27203-92-5," Repeat-dose toxicity studies with tramadol HCl were conducted in mice and rats administered by gavage and in dogs administered by gelatin capsule. One study in dogs compared the effects of an immediate-release formulation and extended-release tablets; the tablets were put in gelatin capsules for administration. The results of the repeat-dose toxicity studies demonstrated that treatment with tramadol HCl was well-tolerated at doses up to 150 mg/kg/day in mice (28 days), 25 mg/kg/day in rats (26 weeks), and 20 mg/kg/day in dogs (39 weeks). In general, clinical signs in mice were limited to lethargy, although high doses produced tonic seizures, and no treatment related clinical signs were observed in rats at the doses administered. No treatment related clinical signs were observed in dogs at doses up to 60 mg/kg/day for 4 weeks, but longer treatment (39 weeks) produced signs of neurotoxicity. A 13-week bridging study was conducted in dogs to compare the toxicity of the immediate-release formulation with that of extended-release tablets (200 or 300 mg/day). The only treatment-related finding was a decrease in body weight gains for dogs treated with the immediate-release formulation; this finding was not observed in dogs treated with the extended-release formulation. None of the toxicology studies demonstrated any treatment-related effects on hematology, clinical chemistry, or urinalysis parameters and there were no treatrnent refated macroscopic or microscopie findings or effects on organ weights. Source: FDA [Internet]. U.S. Food and Drug Administration. Available from: http://www.fda.gov/ ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/20056fc7-7277-4b3b-b330-c8cc293d4b2e/documents/677d1670-2426-4706-9d2b-da515228785e_61bf3ba3-be0c-41b6-8450-9cccb0e49e32.html,,,,,, Tramadol,27203-92-5," LD50, rat oral = 228 mg/kg LD50, mouse oral = 270 mg/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/20056fc7-7277-4b3b-b330-c8cc293d4b2e/documents/f5f860ca-eae7-438c-8053-a48f9dab006e_61bf3ba3-be0c-41b6-8450-9cccb0e49e32.html,,,,,, "trans-(5RS,6SR)-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol",79944-37-9,"study conducted according to OECD test guideline 407, result: NOAEL = 100 mg/kg bw/d Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): study according to OECD test guideline 407 and GLP, the quality is expected to be high ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa0acae3-2f11-4f30-bd65-9c6033c0515c/documents/3858fcf4-f092-4549-a4ad-a405e16085a3_211d5514-0db2-4867-af2c-34ff878627e7.html,,,,,, "trans-(5RS,6SR)-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol",79944-37-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa0acae3-2f11-4f30-bd65-9c6033c0515c/documents/3858fcf4-f092-4549-a4ad-a405e16085a3_211d5514-0db2-4867-af2c-34ff878627e7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "trans-(5RS,6SR)-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol",79944-37-9,"study conducted according to OECD test guideline 401, result: not classified (CLP); Category 5 (GHS) study conducted accoding to OECD test guideline 402, result: not classified acute toxicity study (i.p. application), result: LD50 2000 - 5000 mg/kg bw (in mice)   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): guideline study, the quality is expected to be high Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): guideline study, the quality is expected to be high ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa0acae3-2f11-4f30-bd65-9c6033c0515c/documents/65404578-24c8-468f-a337-c1204bd69992_211d5514-0db2-4867-af2c-34ff878627e7.html,,,,,, "trans-(5RS,6SR)-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol",79944-37-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa0acae3-2f11-4f30-bd65-9c6033c0515c/documents/65404578-24c8-468f-a337-c1204bd69992_211d5514-0db2-4867-af2c-34ff878627e7.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "trans-(5RS,6SR)-6-amino-2,2-dimethyl-1,3-dioxepan-5-ol",79944-37-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa0acae3-2f11-4f30-bd65-9c6033c0515c/documents/65404578-24c8-468f-a337-c1204bd69992_211d5514-0db2-4867-af2c-34ff878627e7.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "trans,trans-2,3',4',5'-Tetrafluor-4-(4'-propylbicyclohexyl-4 -yl)-biphenyl",188289-44-3, The LD50 value of the test item was determined to be greater than 2000 mg/kg bw in rats after oral administration. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fc0fa1b-d6a0-4595-9f3b-9ca505bc61cd/documents/549bb097-99a2-4d18-9785-e5cb1289660b_6493ac43-75a4-4ab4-834f-575bfcb0c821.html,,,,,, "trans,trans-2,3',4',5'-Tetrafluor-4-(4'-propylbicyclohexyl-4 -yl)-biphenyl",188289-44-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fc0fa1b-d6a0-4595-9f3b-9ca505bc61cd/documents/549bb097-99a2-4d18-9785-e5cb1289660b_6493ac43-75a4-4ab4-834f-575bfcb0c821.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "trans-1,4-bis(isocyanatomethyl)cyclohexane",98458-83-4," Based on the results of a dose range finding study it was concluded that a repeated dose study with the undiluted substance is not possible. Taking into account that it was impossible to develop an analytical method it was concluded that it is technically not feasible to dose animals to a stable form of the test item and to conduct a repeated dose study. The considerations are also included in the read across document, attached in Section 13. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1b69641-e2a9-42b2-86a1-be2dd766ffd1/documents/efa9cc68-5206-4dca-9467-6cacf54a58db_02ef266e-689b-409c-a4b5-2c059907e33a.html,,,,,, "trans-1,4-bis(isocyanatomethyl)cyclohexane",98458-83-4," In an acute oral toxicity test, the oral LD50 of 1,4-H6XDI was found to be > 300 mg/kg bw and < 2000 mg/kg bw. In an acute inhalation toxicity, conducted equivalent to OECD 403, the LD50 of 1,3-H6XDI was found to be > 0.147 mg/L and < 0.239 mg/L. An acute dermal toxicity study was performed with 1,3-H6XDI. Since no mortality occurred at 5000 mg/kg bw, the LD50 of 1,3-H6XDI is expected to exceed 5000 mg/kg bw. The results on acute inhalation and acute dermal toxicity are read across to 1,4-H6XDI. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1b69641-e2a9-42b2-86a1-be2dd766ffd1/documents/IUC5-c5564d31-a8df-41de-b974-bf1dc258389e_02ef266e-689b-409c-a4b5-2c059907e33a.html,,,,,, "trans-1,4-bis(isocyanatomethyl)cyclohexane",98458-83-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1b69641-e2a9-42b2-86a1-be2dd766ffd1/documents/IUC5-c5564d31-a8df-41de-b974-bf1dc258389e_02ef266e-689b-409c-a4b5-2c059907e33a.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "trans-1,4-bis(isocyanatomethyl)cyclohexane",98458-83-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1b69641-e2a9-42b2-86a1-be2dd766ffd1/documents/IUC5-c5564d31-a8df-41de-b974-bf1dc258389e_02ef266e-689b-409c-a4b5-2c059907e33a.html,,inhalation,LC50,147.1 mg/m3,adverse effect observed, trans-1-[4-(4-Propylcyclohexyl)-1-cyclohexen-1-yl]-4- (trifluoromethyl)-benzene,90278-32-3, GLP compliant OECD 423: LD50 (oral) > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40906bb7-8c96-46ff-aa72-3ff98931b93f/documents/2c009d73-d5d0-4b6c-a874-5caf7b1fb0b9_23238fda-4e40-4886-9ba1-85d623e8074e.html,,,,,, trans-1-[4-(4-Propylcyclohexyl)-1-cyclohexen-1-yl]-4- (trifluoromethyl)-benzene,90278-32-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/40906bb7-8c96-46ff-aa72-3ff98931b93f/documents/2c009d73-d5d0-4b6c-a874-5caf7b1fb0b9_23238fda-4e40-4886-9ba1-85d623e8074e.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, trans-1-butyl-4-[trans-4-[(E)-prop-1-enyl]cyclohexyl]cyclohexane,694510-10-6, The test material was investigated for acute oral toxicity using in vivo methods. The GLP compliant study was fully compliant with OECD TG 423. The follwing results have been obtained: Acute toxicity: oral: OECD 423: LD50 > 2000 mg/kg bw ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a7872ed-691a-4033-bd80-e4401bb7c97f/documents/c5804616-50ad-4c90-afb9-8403411f2353_ebcb7bb6-3e46-4453-ad20-df003d621d29.html,,,,,, trans-1-butyl-4-[trans-4-[(E)-prop-1-enyl]cyclohexyl]cyclohexane,694510-10-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5a7872ed-691a-4033-bd80-e4401bb7c97f/documents/c5804616-50ad-4c90-afb9-8403411f2353_ebcb7bb6-3e46-4453-ad20-df003d621d29.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Trans-2-[4'-[Difluor(3,4,5-trifluorphenoxy)methyl]-3',5'-difluor[1,1'-biphenyl]-4-yl]-5-propyl-tetrahydro-2H-pyran",700863-48-5," RA to OECD 407: NOAEL=1000 mg/kg bw/d, NOEL=100 mg/kg bw /d ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b8976a17-c081-4f03-adb8-bffcfc28ee6f/documents/33b5b7a4-23d2-43a2-a6b8-6aa84b26fa50_9ad6e02a-02f0-46e4-b354-67968c8ec796.html,,,,,, "Trans-2-[4'-[Difluor(3,4,5-trifluorphenoxy)methyl]-3',5'-difluor[1,1'-biphenyl]-4-yl]-5-propyl-tetrahydro-2H-pyran",700863-48-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b8976a17-c081-4f03-adb8-bffcfc28ee6f/documents/33b5b7a4-23d2-43a2-a6b8-6aa84b26fa50_9ad6e02a-02f0-46e4-b354-67968c8ec796.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Trans-2-[4'-[Difluor(3,4,5-trifluorphenoxy)methyl]-3',5'-difluor[1,1'-biphenyl]-4-yl]-5-propyl-tetrahydro-2H-pyran",700863-48-5," The acute toxicity of the test item was investigated in an acute and dermal toxicity study on rats. The test animals showed no clinical signs (and no mortality) up to the limit dose after oral or dermak administration. Hence, the LD50 is above 2000 mg/Kg bw. The subsequent evaluation on the necessity of a acute test via a second route was done in accordance with Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance, Version 6.0, July 2017, p 374f. Based on the absence of systemic effects after acute oral and dermal administration, a study on acute inhalation toxicity is not required. Furthermore, based on the lack of systemic toxicity after acute oral adminsitration, it is more than evident that an acute study on inhalation would not show any different outcome. Therefore, and due to animal welfare reasons a study on acute inhalation is not required. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8976a17-c081-4f03-adb8-bffcfc28ee6f/documents/0385c784-dce2-4ae4-8b77-2c4a48fbce5d_9ad6e02a-02f0-46e4-b354-67968c8ec796.html,,,,,, "Trans-2-[4'-[Difluor(3,4,5-trifluorphenoxy)methyl]-3',5'-difluor[1,1'-biphenyl]-4-yl]-5-propyl-tetrahydro-2H-pyran",700863-48-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8976a17-c081-4f03-adb8-bffcfc28ee6f/documents/0385c784-dce2-4ae4-8b77-2c4a48fbce5d_9ad6e02a-02f0-46e4-b354-67968c8ec796.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trans-2-[4'-[Difluor(3,4,5-trifluorphenoxy)methyl]-3',5'-difluor[1,1'-biphenyl]-4-yl]-5-propyl-tetrahydro-2H-pyran",700863-48-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8976a17-c081-4f03-adb8-bffcfc28ee6f/documents/0385c784-dce2-4ae4-8b77-2c4a48fbce5d_9ad6e02a-02f0-46e4-b354-67968c8ec796.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "1,3-Dioxane, 2-[4-[difluoro(3,4,5-trifluorophenoxy)methyl]-3,5- difluorophenyl]-5-(trans-4-propylcyclohexyl)-, trans-",798556-07-7, Acute oral LD50 > 2000 mg/kg bw (reference 7.2.1 -1) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/029a3c41-7f34-4e36-9294-a7eb82fe865e/documents/f14d313a-cdc1-402c-99fc-c9b39c0f9067_3fcab726-a3c8-446a-a6e0-3963a7d93770.html,,,,,, "1,3-Dioxane, 2-[4-[difluoro(3,4,5-trifluorophenoxy)methyl]-3,5- difluorophenyl]-5-(trans-4-propylcyclohexyl)-, trans-",798556-07-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/029a3c41-7f34-4e36-9294-a7eb82fe865e/documents/f14d313a-cdc1-402c-99fc-c9b39c0f9067_3fcab726-a3c8-446a-a6e0-3963a7d93770.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "trans-5-butyl-2-(3',3'',4'',5''-tetrafluoro-1,1':4',1''-terphenyl-4-yl)-1,3-dioxane",1182844-21-8, The LD50 value of the test item was determined to be greater than 2000 mg/kg bw after oral administration. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/333aac07-027c-4e99-955a-1f61952670c2/documents/3480da41-86cc-45b3-8c47-b664ff585ecb_b27c5966-cea3-49ec-9c22-a469c3bf86cb.html,,,,,, "trans-5-butyl-2-(3',3'',4'',5''-tetrafluoro-1,1':4',1''-terphenyl-4-yl)-1,3-dioxane",1182844-21-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/333aac07-027c-4e99-955a-1f61952670c2/documents/3480da41-86cc-45b3-8c47-b664ff585ecb_b27c5966-cea3-49ec-9c22-a469c3bf86cb.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, trans-crotonic acid,107-93-7,There is an OECD 422 study on repeated dose toxicity available.  Guideline study according to GLP ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ecf8af38-5f88-4c0b-993d-10ac50bf5af7/documents/2182a6e9-466a-488d-bfd1-8e54f6e7bc0b_0a58934f-b216-40a8-9e13-9a5ac2d36860.html,,,,,, trans-crotonic acid,107-93-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ecf8af38-5f88-4c0b-993d-10ac50bf5af7/documents/2182a6e9-466a-488d-bfd1-8e54f6e7bc0b_0a58934f-b216-40a8-9e13-9a5ac2d36860.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,55 mg/kg bw/day,,rat trans-crotonic acid,107-93-7,Oral: LD50: 2610 mg/kg bw for the rat Inhalation: no effect observedDermal: LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecf8af38-5f88-4c0b-993d-10ac50bf5af7/documents/69f626ab-40b4-4f1a-95eb-0e61d2c76862_0a58934f-b216-40a8-9e13-9a5ac2d36860.html,,,,,, trans-crotonic acid,107-93-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecf8af38-5f88-4c0b-993d-10ac50bf5af7/documents/69f626ab-40b4-4f1a-95eb-0e61d2c76862_0a58934f-b216-40a8-9e13-9a5ac2d36860.html,,oral,LD50,"2,610 mg/kg bw",adverse effect observed, trans-crotonic acid,107-93-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ecf8af38-5f88-4c0b-993d-10ac50bf5af7/documents/69f626ab-40b4-4f1a-95eb-0e61d2c76862_0a58934f-b216-40a8-9e13-9a5ac2d36860.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "trans-cyclohexane-1,2-dinitrilotetraacetic acid",13291-61-7," Two-year feeding studies in rats showed no significant deviations from normal physiological responses nor any evidence of interference with mineral metabolism at levels of calcium EDTA up to 250 mg per kilogram body weight. A subchronic toxicity study (13 weeks) on rats receiving 1.0%, 5.0 and 10.0% Na2H2EDTA showed that animals that received 5.0 or 10.0% EDTA consumed significantly less food than the controls and had lower average body weights.The mortality rate among the rats receiving 10.0% EDTA diet was 60%. A NOAEL of 1670 mg/kg bw /day for Na2H2EDTA was derived. A NOAEL >= 250 mg/kg bw /day was therefore assumed for the substance trans-cyclohexane-1,2-dinitrilotetraacetic acid (CAS 13291-61-7), structurally similar to the substances tested. Up to the dose tested, there was no adverse effect observed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c515e07-1803-46fc-953b-d846dc32abce/documents/01c50008-b57d-48ef-823b-70fa3dd854d6_40d14a47-f764-45a2-a412-6de99bfce085.html,,,,,, "trans-cyclohexane-1,2-dinitrilotetraacetic acid",13291-61-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c515e07-1803-46fc-953b-d846dc32abce/documents/01c50008-b57d-48ef-823b-70fa3dd854d6_40d14a47-f764-45a2-a412-6de99bfce085.html,Chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "trans-cyclohexane-1,2-dinitrilotetraacetic acid",13291-61-7, The acute toxicity of CDTA HHQ was investigated following a single oral administration (10mL/kg in 0.5% aqueous solution of carboxymethylcellulose) to the Sprague Dawley rat followed by a 14-day observation period. No mortality occurred and no signs of toxicity were observed in the 6 animals following dosing at 2000mg/kg.These results indicate that the test item CDTA HHQ did not induce toxic effects in the rat following oral administration of a single dose at a level of 2000mg/kg. The lack of mortality demonstrates the acute toxicity estimate (ATE) to be greater than 2000mg/kg body weight. In a repeated dose range finding study rats were exposed to aerosol of the test substance. 6 death occured in the high dose group. No deaths occured in the middle dose group (300 mg/m³). Taking into account that the exposure duration was significantly extended compared to an acute toxicity study it is reasonable that less than 50% of the animals of the highest dose group would die when exposed to the substance once for 4 hours. Thus the LC50 can be stated as: LC50 > 1000 mg/m³ (nominal) LC50 > 1103 mg/m³ (actual) This leads to the following classification according to CLP: acute oral toxicity: not classified acute dermal toxicity: not data available acute inhalative toxicity: classified as acute toxic category 4 (H332) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c515e07-1803-46fc-953b-d846dc32abce/documents/e2c06928-ee30-4da6-9249-67c56517cdd4_40d14a47-f764-45a2-a412-6de99bfce085.html,,,,,, "trans-cyclohexane-1,2-dinitrilotetraacetic acid",13291-61-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c515e07-1803-46fc-953b-d846dc32abce/documents/e2c06928-ee30-4da6-9249-67c56517cdd4_40d14a47-f764-45a2-a412-6de99bfce085.html,,inhalation,LC50,"1,103 mg/m3",adverse effect observed, "Trans-esterification product of castor oil and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol",68551-65-5, Nonspecific toxicity in rats in repeated dose toxicity study ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed3f7fed-4918-463c-b75e-50b1f93d6022/documents/56c4bf24-4760-4585-9f8f-071b99b6661e_06ff0066-3ea5-48ea-826f-8297fadffff5.html,,,,,, "Trans-esterification product of castor oil and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol",68551-65-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ed3f7fed-4918-463c-b75e-50b1f93d6022/documents/56c4bf24-4760-4585-9f8f-071b99b6661e_06ff0066-3ea5-48ea-826f-8297fadffff5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,630 mg/kg bw/day",,rat "Trans-esterification product of castor oil and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol",68551-65-5, Not acutely toxic ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed3f7fed-4918-463c-b75e-50b1f93d6022/documents/72c781c7-d7a7-46da-83e0-10ae0cec306f_06ff0066-3ea5-48ea-826f-8297fadffff5.html,,,,,, "Trans-esterification product of castor oil and 2-ethyl-2-(hydroxymethyl)propane-1,3-diol",68551-65-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ed3f7fed-4918-463c-b75e-50b1f93d6022/documents/72c781c7-d7a7-46da-83e0-10ae0cec306f_06ff0066-3ea5-48ea-826f-8297fadffff5.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Tri(isopropoxy)vinylsilane,18023-33-1," The key read-across study from tris(isopropenyloxy)(vinyl)silane (CAS 15332-99-7), conducted according to a protocol similar to OECD test guideline, but not in compliance with GLP, reported an LD50 value of > 18000 mg/kg bw (TNO, 1983). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97f17067-4c08-470a-89fc-071689a82069/documents/b50bdbbc-4052-4dae-b88e-6cf23c6f0554_213f43b2-04bc-4993-bf41-d4d233933713.html,,,,,, Tri(isopropoxy)vinylsilane,18023-33-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97f17067-4c08-470a-89fc-071689a82069/documents/b50bdbbc-4052-4dae-b88e-6cf23c6f0554_213f43b2-04bc-4993-bf41-d4d233933713.html,,oral,LD50,"18,000 mg/kg bw",no adverse effect observed, Triacetoxyethylsilane,17689-77-9,"In a seven-day range-finding study conducted to determine appropriate doses for administration in an OECD TG 422 study, a NOAEL could not be determined for triacetoxyethylsilane due to the corrosive effects of this substance on the oesophagus and stomach (DCC, 2004).The study was not conducted to a guideline or to GLP since it was a range-finder only. On the basis of this result and results of the skin corrosion studies, it is concluded that it is not feasible to conduct the OECD TG 422 study, which is in agreement with the decision of the US EPA. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47a88422-65f7-4cf3-8355-df1c4addb2f1/documents/IUC5-749e1dea-ed05-4072-9ac0-a8ddc9185904_b09bc6e5-c0e5-4d05-8413-20b84cc96b8e.html,,,,,, Triacetoxyethylsilane,17689-77-9,"In the key oral gavage study conducted to the now deleted OECD 401 and to GLP (Huntingdon Life Sciences, 2000) the LD50 for triacetoxyethylsilane was 1460 mg/kg bw in rats. Clinical signs and macroscopic findings appeared to be related to the corrosive properties of the test substance on the stomach. There are no dermal or inhalation studies available, and it is not scientifically feasible to conduct new tests as the test substance has corrosive properties. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47a88422-65f7-4cf3-8355-df1c4addb2f1/documents/IUC5-c049a781-2095-4579-a011-46a84cb52e7d_b09bc6e5-c0e5-4d05-8413-20b84cc96b8e.html,,,,,, Triacetoxyethylsilane,17689-77-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47a88422-65f7-4cf3-8355-df1c4addb2f1/documents/IUC5-c049a781-2095-4579-a011-46a84cb52e7d_b09bc6e5-c0e5-4d05-8413-20b84cc96b8e.html,,oral,LD50,"1,460 mg/kg bw",, Triacetoxyvinylsilane,4130-08-9," Weight of evidence: Based on experimental results obtained in repeated dose toxicity studies with supporting substances acetic acid and sodium acetate, read-across approach was applied and the NOAEL (28 days in rats) for triacetoxyvinylsilane was calculated to be greater than 3397.83 mg/kg bw/day (based on no effects observed at the highest dose). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9141d45b-a081-4e58-a282-c1b65418a612/documents/IUC5-7216e9eb-ec2d-4bac-a2aa-ba66f5ce1de2_a8194a26-12fa-4d37-957e-7ab3e6cfbf65.html,,,,,, Triacetoxyvinylsilane,4130-08-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9141d45b-a081-4e58-a282-c1b65418a612/documents/IUC5-7216e9eb-ec2d-4bac-a2aa-ba66f5ce1de2_a8194a26-12fa-4d37-957e-7ab3e6cfbf65.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"3,397.83 mg/kg bw/day",,rat Triacetoxyvinylsilane,4130-08-9," Acute toxicity (oral): Data waiving (study scientifically not necessary): In accordance with column 2 of REACH Annex VIII, the study does not to be conducted since the substance is classified as corrosive to the skin. Acute toxicity (inhalation): Data waiving (study scientifically not necessary): In accordance with column 2 of REACH Annex VIII, the study does not to be conducted since the substance is classified as corrosive to the skin. Acute toxicity (dermal): Data waiving (study scientifically not necessary ): In accordance with column 2 of REACH Annex VIII, the study does not to be conducted since the substance is classified as corrosive to the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9141d45b-a081-4e58-a282-c1b65418a612/documents/IUC5-71623206-92d9-477b-8715-69797cbe3654_a8194a26-12fa-4d37-957e-7ab3e6cfbf65.html,,,,,, Trialuminium bismuth hexaoxide,12284-76-3, An OECD 422 study (repeated dose and reproductive screen) is available on the substance providing information on the effects of repeated dosing with the test substance. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7b1d1d5-9b64-4f54-bbb4-03009da952bb/documents/a770bf74-566b-4892-b788-6fa588db1ef1_01695ec6-73a5-4283-9a7b-033759e3324d.html,,,,,, Trialuminium bismuth hexaoxide,12284-76-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7b1d1d5-9b64-4f54-bbb4-03009da952bb/documents/a770bf74-566b-4892-b788-6fa588db1ef1_01695ec6-73a5-4283-9a7b-033759e3324d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Trialuminium bismuth hexaoxide,12284-76-3, Two acute toxicity studies are available conducted by the oral and inhalation routes of administration and in accordance with appropriate OECD guidelines. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7b1d1d5-9b64-4f54-bbb4-03009da952bb/documents/8a82a507-1d4b-4eec-bd66-a4d13724ee13_01695ec6-73a5-4283-9a7b-033759e3324d.html,,,,,, Trialuminium bismuth hexaoxide,12284-76-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7b1d1d5-9b64-4f54-bbb4-03009da952bb/documents/8a82a507-1d4b-4eec-bd66-a4d13724ee13_01695ec6-73a5-4283-9a7b-033759e3324d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Trialuminium bismuth hexaoxide,12284-76-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7b1d1d5-9b64-4f54-bbb4-03009da952bb/documents/8a82a507-1d4b-4eec-bd66-a4d13724ee13_01695ec6-73a5-4283-9a7b-033759e3324d.html,,inhalation,LC50,"5,070 mg/m3",no adverse effect observed, Triammonium citrate,3458-72-8," There are no acute oral toxicity data available for Triammonium citrate. However, data for the constituents of Triammonium citrate, namely citric acid and ammonium (other ammonium salts, e.g. ammonium sulfate) are available. Citric acid: Published data, several studies conducted according to OECD 401, species used were rats, mice and rabbits, LD50 determined: mice 5400 mg/kg bw, rats either 3000 mg/kg bw or 12000 mg/kg bw, rabbits < 7000 mg/kg bw. Published data from database: Toxicological Data, compiled by the National Institute of Health (NIH), USA, selected and distributed by Technical Database Services (TDS), New York, 2009, rats applied citric acid via gavage, LD50 = 3000 mg/kg bw Published data (Weiss et al., 1923): Study not performed according to OECD Guidelines because study was conducted prior to implementation of OECD and GLP Guidelines. Study in rabbits LG50 not determined but estimated fatal dose = 7000 mg/kg bw. Ammonium sulfate: Published results from Yamanaka et al., 1990, study similar to acute toxic class method, conducted to rats, no mortality at the highest dose of 2000 mg/kg bw, LD50 > 2000 mg/kg bw. Results obtained from OECD SIDS report, method similar to acute toxic class method, doses applied: 2500, 3200, 4000, 5000, 6400 mg/kg bw applied by oral gavage to rats, LD50 = 4250 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6bb1b11-e0b9-481a-93d2-ea2380918bac/documents/3ab51e3e-33d1-4f67-8814-d71a15bc6598_d6c3daad-7368-494b-ac64-6fc9b0bd700b.html,,,,,, Triammonium citrate,3458-72-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b6bb1b11-e0b9-481a-93d2-ea2380918bac/documents/3ab51e3e-33d1-4f67-8814-d71a15bc6598_d6c3daad-7368-494b-ac64-6fc9b0bd700b.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Triammonium hydrogen ethylenediaminetetraacetate,15934-01-7,"There are no repeated dose studies with triammonium dihydrogen EDTA available. However, under physiological conditions (pH 7-9) any EDTA salt as well as edetic acid will dissociate into the cations and the respective anionic species of edetic acid depending on the dissociation equilibria of edetic acid. Under the assumption of this equivalence it is likely that all EDTA salt chelate ions in vivo. Therefore repeated dose studies with Na2EDTA and Na3EDTA have been used as read across. (For read-across justification refer to section 13).A 90 day (Na2EDTA) as well as a 2 years (Na3EDTA) feeding study on rats provide reliable toxicological information for an overall NOAEL of about 500 mg/kg bw.A NOAEC value of 3 mg/m³ air was established in a subchronic toxicity study with Na2H2EDTA. (For read-across justification refer to section 13)It can also be ruled out that at this concentrations ammonium ions may cause any toxic effect, as ammonium ions are converted to urea in the liver or are utilized to form in amino acids and proteins. There is only a limited number on repeated dose studies with other ammonium salts available, however oral studies on rats with NH4Cl or ammonium sulfate report even higher NOAELs. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bd241358-9c27-43df-824d-1903d05a761a/documents/IUC5-b38a7cd6-b657-4716-8dc3-cc9073f727c3_902ca360-179f-4870-9a91-95b1b7b0914a.html,,,,,, Triammonium hydrogen ethylenediaminetetraacetate,15934-01-7,"No studies on the acute toxicity of triammonium hydrogen ethylenediaminetetraacetate are available. Like the sodium salts of EDTA, ammonium salt of EDTA are likely to dissociate at physiological pH to the EDTA anion and the ammonium ion, therefore the acute oral toxicity data of EDTA free acid and its sodium salts have be used for a estimation of acute toxicity triammonium hydrogen EDTA. (For read-across justification also refer to section 13).The acute oral LD50 values were 2500 mg/kg bw (Na2EDTA) and 4500 mg/kg bw (EDTA free acid), respectively. The LOAEC established in an inhalation study with Na2EDTA was considered to be 30 mg/m³ air.Furthermore it is highly unlikely that EDTA induced acute dermal toxicity as neither Ca or Na salts of EDTA are able to penetrate the skin. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bd241358-9c27-43df-824d-1903d05a761a/documents/IUC5-d9281c73-9817-4422-9dd7-f8b24d28da18_902ca360-179f-4870-9a91-95b1b7b0914a.html,,,,,, Tribenzylamine,620-40-6,"The test item has no acute toxic potential under the conditions of the present study, and the LD50 value is higher than 2000 mg/kg after single oral administration in female rats (reference 7.2.1-1). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): A GLP and guideline conform study was conducted and is considered of sufficient quality. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a185f9e4-8dec-4666-80e4-2b69a9528734/documents/b1c5673f-9140-4736-8443-009725e0748c_c3d6993b-7784-46e1-bf84-137e70ddab6d.html,,,,,, Tribenzylamine,620-40-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a185f9e4-8dec-4666-80e4-2b69a9528734/documents/b1c5673f-9140-4736-8443-009725e0748c_c3d6993b-7784-46e1-bf84-137e70ddab6d.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Triboron trimethyl hexaoxide,102-24-9," TMBX is hydrolytically unstable and breaks down to form methanol and boric acid in the presence of water, these species can be expected to be found in the body fluids and tissues following absorption by any route of administration. Therefore, an assessment of repeat dose toxicity was conducted taking account of the hydrolysis breakdown products of TMBX. A number of sub-chronic and chronic studies on boric acid and disodium tetraborate decahydrate were carried out in rats, mice and dogs. Most support that boron can cause adverse haematological effects and that the main target organ of boron toxicity is the testis. The NOAEL for fertility effects is equivalent to 17.5 mg B/kg bw/day that corresponds to NOAEL of 100 mg Boric Acid/kg bw (Weir, 1966a, b). A reliable oral NOAEL for methanol toxicity following repeated exposure is not available. A LOAEL of 2340 mg/kg bw/day resulted from a study in monkeys where all the subjects died within 3 days of the initial dosing (Rao et al, 1977).A further oral repeat dose study in monkeys (Martin-Amat et al, 1977), which examined the ocular toxicity following an initial dose of 2000 mg/kg bw on day 1 followed by 500 mg/kg at varying intervals did not allow a NOAEL to be derived, despite producing ocular lesions over the course of the study. The most appropriate point of departure following repeated oral exposure is based on the NOAEL for Boric acid of 17.5 mg B/kg bw day, an equivalent NOAEL for TMBX of 93.73 mg/kg bw/day can be derived. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ef4b2ab-27fa-4c09-976d-63c6eb473418/documents/0295b5c7-b80d-43f6-899c-366b5db68bed_a641c75b-4ee2-4b5f-a5fc-f9f4fad480c9.html,,,,,, Triboron trimethyl hexaoxide,102-24-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ef4b2ab-27fa-4c09-976d-63c6eb473418/documents/0295b5c7-b80d-43f6-899c-366b5db68bed_a641c75b-4ee2-4b5f-a5fc-f9f4fad480c9.html,Chronic toxicity – systemic effects,oral,NOAEL,93.7 mg/kg bw/day,,rat Triboron trimethyl hexaoxide,102-24-9," TMBX is hydrolytically unstable and breaks down to form methanol and boric acid in the presence of water, these species can be expected to be found in the body fluids and tissues following absorption by any route of administration. Therefore, an assessment of acute toxicity potential was conducted taking account of the hydrolysis breakdown products of TMBX. Acute oral, dermal and inhalation studies have been performed with boric acid. Experimental data showed low acute toxicity to boric acid. The mean of the male and female values were obtained from the key study (oral route; Keller 1962). The LD50 is equivalent to 658.9 mg B/kg bw. LD50 values of >2000 mg/kg were recorded for both oral and dermal routes and > 2 mg/L for the acute inhalation study. The highest attainable inhalation concentration was 2.12 mg/L. Boric acid is of low acute toxicity. Although some of the acute oral studies were not of modern standards and were performed prior to the introduction of GLP, they are reproducible across a number of studies and species and of acceptable quality. For acute dermal and acute inhalation some studies do meet the modern GLP standard. In rats, LD50 values for methanol after single oral administration range from 1187 to 2769 mg/kg bw, depending on the concentration of the aqueous solution used (BASF 1975, concentrations 15 to 35%, not further specified). In Rhesus monkeys orally dosed with 6000 mg/kg bw, the retina and the optic papilla showed extended oedema, and the pupils were wide and non-responsive. Six of 8 animals exhibited cystic degeneration of the outer retinal granular layer, and in one animal there was evidence of significant demyelinisation of the optic nerve. Histological lesions were seen in the putamen and nucleus caudatus in 3 of 8 animals. All of these effects were most pronounced after early compensation of acidosis using bicarbonate application, because the monkeys generally did not survive those high doses of methanol but after early treatment with bicarbonate (Potts, 1955; Potts et al., 1955). There was no evidence of marked acidosis in 12 Rhesus monkeys (28 applications) after sublethal doses up to 6000 mg/kg bw. Specifically, there was no hyperventilation, no increase in urinary excretion of organic acids, or shift in serum bicarbonate. Blindness was seen in only one surviving monkey dosed with 9000 mg/kg bw; the effect was transient four days after exposure. The LD50 was between 7000 and 9000 mg/kg bw (Cooper and Felig, 1961). Dermal: Methanol is classified as acute toxic Cat.3 (H301,H311,H331) according to the EU Regulation 1272/2008. Therefore, animal testing regarding acute dermal toxicity is not necessary. In rabbits, a dermal LD50 of about 17,000 mg/kg bw was found. No further details were reported (Rowe and McCollister, 1981).   Human data: Due to misuse of methanol in the production of alcoholic beverages oral ingestion is the most frequent route of poisoning, death and blindness from methanol. However, there are also case reports from percutaneous absorption or vapor inhalation having elicited the methanol acute toxic syndrome. A blood level of 500 mg/L methanol in acutely poisoned patients is generally regarded as an indication for hemodialysis. This blood concentration can transiently be achieved in an adult person (70 kg) by ingestion of 0.4 mL methanol/kg bw (Kavet and Nauss, 1990). Generally in humans, transient central nervous system (CNS) effects appear at blood methanol levels of 200 mg/L and serious ocular symptoms appear above 500 mg/L ranging from mild photophobia, misty or blurred vison to markedly reduced visual acuity and total blindness (Kavet and Nauss, 1990; Dethlefs and Naraqi, 1978). Acute methanol intoxication evolves in a well-defined pattern. First, a mild depression of the CNS occurs which is followed by an asymptomatic latent period commonly lasting 12 to 14 hours. Clinical symptoms include headache, dizziness, nausea and vomiting, abdominal pain, and labored, periodic breathing and mag progress to coma and death from respiratory failure (Kavet and Nauss, 1990). The minimal acute methanol dose to humans that can result in death is considered to be 300 to 1000 mg/kg by ingestion. Fatalities have occurred in untreated patients with initial methanol blood levels in the range of 1500 to 2000 mg/L (IPCS/WHO, 1997). In general, coma, seizures and prolonged acidosis were poor prognostic signs (Naraqi et al., 1979). Such high and potentially lethal blood methanol levels are less likely to be achieved from inhalation exposure. Exposure to 0.26 mg/L methanol for 4 hours was without significant physiologic effects in human volunteers (Muttray et al., 2001).   In conclusion, there are two dominating acute effects from methanol: blindness and metabolic acidosis. For the latter, formate is considered to be the ultimate toxicant in acute methanol intoxication in humans. Acidosis and ophthalmologic changes are typical effects in primates. They do not occur in rodents or rabbits, which are able to remove formate more efficiently. In these animals, CNS depression, narcosis and death are the leading symptoms of intoxication. Although the mechanism for optic nerve damage from exposure to methanol has not been established, potential mechanisms and the possible role of formate are discussed in section 5.10.3. Although the lethal dose of methanol is high for most experimental animals (> 2000 mg/kg bw after single oral administration) these data are not employed for classification. The classification is only based upon the experiences in humans and classifies methanol as acutely toxic by oral, dermal and inhalative exposure and, furthermore, as capable of inducing serious irreversible effects upon single exposure by all of these routes. Upon hydrolysis TMBX yields 34.1 g of methanol and 65.9g of boric acid per 100g of the parent substance. The oral ATE for TMBX is calculated as 293 mg/kg based upon a converted ATE point estimate of 100 mg/kg bw for methanol (Acute oral category 3). Boric acid is disregarded as the derived LD50 value is above the oral limit does of 2000mg/kg bw.   The dermal ATE for TMBX is calculated as 879.8 mg/kg based upon a converted ATE point estimate of 300 mg/kg bw for methanol (Acute dermal category 3). Boric acid is disregarded as the derived LD50 value is above the oral limit does of 2000mg/kg bw. No inhalation toxicity is expected for TMBX based upon its vapour pressure and the low likelihood of generation of aerosol or droplets during its use. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ef4b2ab-27fa-4c09-976d-63c6eb473418/documents/30d5ac4e-3ff9-4143-800f-867b902ae84e_a641c75b-4ee2-4b5f-a5fc-f9f4fad480c9.html,,,,,, Triboron trimethyl hexaoxide,102-24-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ef4b2ab-27fa-4c09-976d-63c6eb473418/documents/30d5ac4e-3ff9-4143-800f-867b902ae84e_a641c75b-4ee2-4b5f-a5fc-f9f4fad480c9.html,,oral,LD50,293 mg/kg bw,adverse effect observed, Triboron trimethyl hexaoxide,102-24-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ef4b2ab-27fa-4c09-976d-63c6eb473418/documents/30d5ac4e-3ff9-4143-800f-867b902ae84e_a641c75b-4ee2-4b5f-a5fc-f9f4fad480c9.html,,dermal,LD50,879.8 mg/kg bw,adverse effect observed, Tributyl borate,688-74-4," Tributyl borate is rapidly hydrolyzed to Boric acid and n-Butanol in the presence of water or moisture in the air (18.3 sec at 21°C). Reliable endpoint data of the hydrolysis products n-Butanol and Boric acid are used, which is entirely appropriate to draw conclusions on the acute toxicity of Tributyl borate by the oral route: 1) Hydrolysis product n-Butanol LD50 in female rats: 2290 mg/kg bw. 2) Hydrolysis product Boric acid - LD50 in male rats: 3450 mg/kg bw (2950 - 4040 mg/kg bw); - LD50 in female rats 4080 mg/kg bw (3640 - 4560 mg/kg bw). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a7398a3-c4bc-4dc8-ace0-f4cfff367009/documents/231934a9-e849-47aa-a67f-c2c65df50833_cf718740-70ee-4ae0-aabb-27955a8e5966.html,,,,,, Tributylamine,102-82-9," Repeated dose toxicity of tributylamine has been investigated in a 90-day study in Wistar Han rats which received 0, 25, 75 and 225/150 mg/kg bw/day by gavage (dosage in the high dose females was reduced from day 50 onward due to mortality). Test item-related mortalities were present in one male and four females at 225 mg/kg/day, which were considered to be adverse. The substance was well tolerated up to 75 mg/kg bw/day in males and 150 mg/kg bw/day in females. Effects on liver weight and histopathology (centrilobular histopathology) in all dose groups, which were completly reversible in females and partially reversible in males during the recovery period, were considered to be adaptive but not adverse. No other toxicological relevant findings were recorded. Based on the adverse effect (early death) observed in animals treated at 225/150 mg/kg/day, the No Observed Adverse Effect Level (NOAEL) for tributylamine was established to be 75 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0f35a14-163d-4f7a-ba19-ebb57560df3a/documents/63f095e4-695c-473b-a0b7-1740b3ec710d_02e48479-b907-4410-baff-7e96c1e59616.html,,,,,, Tributylamine,102-82-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c0f35a14-163d-4f7a-ba19-ebb57560df3a/documents/63f095e4-695c-473b-a0b7-1740b3ec710d_02e48479-b907-4410-baff-7e96c1e59616.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat Tributylamine,102-82-9,"The LD50 for acute oral toxicity is 420 mg/kg bw (RL 2, rat). The acute dermal toxicity is reported with a LD50 of 195 mg/kg bw (RL 2, rabbit) as well as the toxicity via inhalation is characterised by a LC50 of 500 mg/m³ (RL 1, rat). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0f35a14-163d-4f7a-ba19-ebb57560df3a/documents/f4b48cfd-7690-4b17-8a0b-c95d85461b29_02e48479-b907-4410-baff-7e96c1e59616.html,,,,,, Tributylamine,102-82-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0f35a14-163d-4f7a-ba19-ebb57560df3a/documents/f4b48cfd-7690-4b17-8a0b-c95d85461b29_02e48479-b907-4410-baff-7e96c1e59616.html,,oral,LD50,420 mg/kg bw,adverse effect observed, Tributylamine,102-82-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0f35a14-163d-4f7a-ba19-ebb57560df3a/documents/f4b48cfd-7690-4b17-8a0b-c95d85461b29_02e48479-b907-4410-baff-7e96c1e59616.html,,dermal,LD50,195 mg/kg bw,adverse effect observed, Tributylamine,102-82-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c0f35a14-163d-4f7a-ba19-ebb57560df3a/documents/f4b48cfd-7690-4b17-8a0b-c95d85461b29_02e48479-b907-4410-baff-7e96c1e59616.html,,inhalation,LC50,500 mg/m3,adverse effect observed, Tributylethylammonium ethyl sulphate,68052-51-7,"In an oral 28-day repeated dose toxicity study with TBEAES performed in accordance with current OECD/EC test guidelines, the NOAEL in rats was determined to be >=1000 mg/kg bw/day based on the absence of adverse effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e96c44ac-df74-41f7-9768-21b08c362cd1/documents/a30e568e-71ca-4432-a44a-5f8fb78a0762_9d32d7e3-8df7-4a9d-bd36-903b3c570ff3.html,,,,,, Tributylethylammonium ethyl sulphate,68052-51-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e96c44ac-df74-41f7-9768-21b08c362cd1/documents/a30e568e-71ca-4432-a44a-5f8fb78a0762_9d32d7e3-8df7-4a9d-bd36-903b3c570ff3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tributylethylammonium ethyl sulphate,68052-51-7,"Acute oral and dermal studies with TBEAES performed in accordance with current OECD/EC test guidelines and GLP principles, showed LD50 values >2000 mg/kg bw for acute oral and dermal toxicity in rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e96c44ac-df74-41f7-9768-21b08c362cd1/documents/fdac7c0f-51b5-4473-9034-432c6a1da32f_9d32d7e3-8df7-4a9d-bd36-903b3c570ff3.html,,,,,, Tributylmethylammonium chloride,56375-79-2,"In two oral OECD 422 screening study with MTBAC in rats (Klimisch 1 study), the NOAEL was determined to be >=1000 mg/kg bw/day, based on no adverse effects seen at 1000 mg/kg bw/ day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e56319e0-2c9e-4862-b448-0df9680778db/documents/IUC5-b299fa7c-4909-4e87-abbf-2c4ad1f4c379_b8ee353e-26f1-4b97-aa3a-f36b9a20fcc9.html,,,,,, Tributylmethylammonium chloride,56375-79-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e56319e0-2c9e-4862-b448-0df9680778db/documents/IUC5-b299fa7c-4909-4e87-abbf-2c4ad1f4c379_b8ee353e-26f1-4b97-aa3a-f36b9a20fcc9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tributylmethylammonium chloride,56375-79-2,"Two acute oral and two acute dermal toxicity studies are available, all performed with MTBAC according to OECD/EC test guidelines and GLP principles. The acute oral LD50 is >2000 mg/kg/bw based on a weight of evindence and the acute dermal LD50 is >1000 <2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e56319e0-2c9e-4862-b448-0df9680778db/documents/IUC5-816c5453-9109-469b-8fc3-e10e9bcf1a29_b8ee353e-26f1-4b97-aa3a-f36b9a20fcc9.html,,,,,, Tributylmethylammonium chloride,56375-79-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e56319e0-2c9e-4862-b448-0df9680778db/documents/IUC5-816c5453-9109-469b-8fc3-e10e9bcf1a29_b8ee353e-26f1-4b97-aa3a-f36b9a20fcc9.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Tributylmethylammonium chloride,56375-79-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e56319e0-2c9e-4862-b448-0df9680778db/documents/IUC5-816c5453-9109-469b-8fc3-e10e9bcf1a29_b8ee353e-26f1-4b97-aa3a-f36b9a20fcc9.html,,dermal,LD50,"1,000 mg/kg bw",adverse effect observed, Tricarbonyl(methylcyclopentadienyl)manganese,12108-13-3,"The most relevant route of exposure to mmt is the inhalation route. A reliable subchronic study on mice, rats, and monkeys, performed similar to OECD 413, was determined to be the key study for this endpoint as it addresses the requirements for repeated-dose toxicity. From this study, it was determined that the NOAEC was 30 mg/m3 of mmt in air for the monkey based on a lack of toxicologically significant effects observed at this dose in the monkey. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9494d83b-1cf5-412b-8271-23feb5f70f9b/documents/3628f4f6-7e70-4547-ab31-d1bb73040d9b_ab85a7a7-2ea6-4010-a90e-51fc64011238.html,,,,,, Tricarbonyl(methylcyclopentadienyl)manganese,12108-13-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9494d83b-1cf5-412b-8271-23feb5f70f9b/documents/3628f4f6-7e70-4547-ab31-d1bb73040d9b_ab85a7a7-2ea6-4010-a90e-51fc64011238.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,30 mg/m3,,monkey Tricarbonyl(methylcyclopentadienyl)manganese,12108-13-3," For acute oral toxicity, the LD50 of 51.8 mg/kg bw/day) was used for purposes of classification and labeling of mmt as it was the lowest LD50 from a study of sufficient quality. For acute inhalation toxicity, the LC50 of 0.000076 mg/m3 was used for purposes of classification and labeling of mmt as it was the lowest LC50 from a study of sufficient quality. For acute dermal toxicity, the LD50 of 140 mg/kg was used for purposes of classification and labeling of mmt as it was the lowest LD50 from a study of sufficient quality. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9494d83b-1cf5-412b-8271-23feb5f70f9b/documents/5c3e126f-b68a-4f1b-b578-58934fd9bc4c_ab85a7a7-2ea6-4010-a90e-51fc64011238.html,,,,,, Tricarbonyl(methylcyclopentadienyl)manganese,12108-13-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9494d83b-1cf5-412b-8271-23feb5f70f9b/documents/5c3e126f-b68a-4f1b-b578-58934fd9bc4c_ab85a7a7-2ea6-4010-a90e-51fc64011238.html,,oral,LD50,51.8 mg/kg bw,adverse effect observed, Tricarbonyl(methylcyclopentadienyl)manganese,12108-13-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9494d83b-1cf5-412b-8271-23feb5f70f9b/documents/5c3e126f-b68a-4f1b-b578-58934fd9bc4c_ab85a7a7-2ea6-4010-a90e-51fc64011238.html,,dermal,LD50,140 mg/kg bw,adverse effect observed, Tricarbonyl(methylcyclopentadienyl)manganese,12108-13-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9494d83b-1cf5-412b-8271-23feb5f70f9b/documents/5c3e126f-b68a-4f1b-b578-58934fd9bc4c_ab85a7a7-2ea6-4010-a90e-51fc64011238.html,,inhalation,LC50,0 mg/m3,adverse effect observed, "Trichloro(2,4,4-trimethylpentyl)silane",18379-25-4,"No repeat-dose toxicity data are available for trichloro(2,4,4-trimethylpentylsilane), therefore good quality studies for the related substances triethoxy(2,4,4-trimethylpentylsilane) and (2,4,4-trimethylpentyl)silane have been read-across. A reliable 28-day oral (gavage) study conducted in male and female rats, with a 14-day recovery period, conducted according to OECD 407 and in compliance with GLP, is the key study for the read-across substance triethoxy(2,4,4-trimethylpentylsilane). This study identified an NOAEL value of 40 mg/kg bw/day, with bladder and liver effects, possibly but not clearly reversible, at the LOAEL of 200 mg/kg bw/day.The key inhalation study was a 28-day inhalation study with trimethoxy(2,4,4-trimethylpentyl)silane which was conducted according to OECD 412 and in compliance with GLP. Four groups of 10 males and 10 females rats were exposed to trimethoxy(2,4,4-trimethylpentyl)silane (CAS 34396-03-7) at concentrations of 0, 0.3, 1.5 and 3 mg/l for 28 days (6 hours/day, 5 days/week). After the exposure period five male and five female rats of each group were kept during a 14 d recovery before necropsy. Only some clinical signs have been observed shortly after exposure in the high and mid dose group. There were no treatment related effects on hematology, clinical chemistry, urinalysis, organ weights and gross pathology. There were signs of minimal intense alveolar irritation (isolated and small clusters of foam cells) in several high dose animals. Overall the NOAEL for this study was considered to be 3 mg/l. Based on gravimetrical and chemical verification of the exposure concentrations it can be concluded that animals were exposed to a mixture of aerosol/vapour and therefore systemic availability of the substance is expected, too. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c248d55-e872-4f21-8fbc-79de07469d84/documents/IUC5-f2e0428e-eafa-4497-92fd-d600987a1965_236f7f65-633e-4d7d-9820-cc7596b2d672.html,,,,,, "Trichloro(2,4,4-trimethylpentyl)silane",18379-25-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c248d55-e872-4f21-8fbc-79de07469d84/documents/IUC5-f2e0428e-eafa-4497-92fd-d600987a1965_236f7f65-633e-4d7d-9820-cc7596b2d672.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,200 mg/kg bw/day,,rat "Trichloro(2,4,4-trimethylpentyl)silane",18379-25-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c248d55-e872-4f21-8fbc-79de07469d84/documents/IUC5-f2e0428e-eafa-4497-92fd-d600987a1965_236f7f65-633e-4d7d-9820-cc7596b2d672.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"3,000 mg/m3",,rat "Trichloro(2,4,4-trimethylpentyl)silane",18379-25-4,"Only one acute toxicity study is available for trichloro (2,4,4-trimethypentyl)silane. In a reliable oral study, conducted in accordance with OECD 423 (acute toxic class method) the LD50 for rats was determined to be in the range 25-200 mg/kg when dosed in corn oil. Slight to moderate reduced motiltiy, ataxia and dyspnoea, slightly reduced muscle tone or adopting a lateral or abdominal postition were noted in all animals of the 2000 mg/kg bw group. There are no data for dermal and inhalation routes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c248d55-e872-4f21-8fbc-79de07469d84/documents/IUC5-c19186fe-ce3e-4f33-bb0a-30c116a450a3_236f7f65-633e-4d7d-9820-cc7596b2d672.html,,,,,, "Trichloro(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane",78560-45-9,"No repeated dose data are available for [2-(perfluorohexyl)ethyl]trichlorosilane (CAS 78560-45-9; EC 278-947-6). Consequently, the reliable oral screening study is read across from alkoxysilane analogue [2-(perfluorohexyl)ethyl]triethoxysilane (CAS 51851-37-7, EC 257-473-3).    In the oral screening study with [2-(perfluorohexyl)ethyl]trichlorosilane in the rat, conducted according to OECD Test Guideline 422 and in compliance with GLP, the reported NOAEL for general systemic toxicity including effects on the peripheral nervous system was 50 mg/kg bw/day (Eurofins, 2018, reliability 1).   In the key inhalation study with the HCl, conducted in a manner similar to OECD Test Guideline 413 and in compliance with GLP (Toxigenics Inc., 1984, reliability 2), the No Observed Adverse Effect Concentration (NOAEC) for systemic effects was determined to be 20 ppm gas (nominal) in rats and mice based lower body weight following exposure to 50 ppm gas (nominal). A NOAEC for local effects was not established since irritant/corrosive effects were observed at all concentrations tested. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b938da21-a82c-4233-946e-37c7c0784a31/documents/83b131eb-cb1b-4752-979f-f68f7a683c82_4700d377-b994-4223-a788-2ed4a55f8a02.html,,,,,, "Trichloro(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane",78560-45-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b938da21-a82c-4233-946e-37c7c0784a31/documents/83b131eb-cb1b-4752-979f-f68f7a683c82_4700d377-b994-4223-a788-2ed4a55f8a02.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Trichloro(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane",78560-45-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b938da21-a82c-4233-946e-37c7c0784a31/documents/83b131eb-cb1b-4752-979f-f68f7a683c82_4700d377-b994-4223-a788-2ed4a55f8a02.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,20 ,, "Trichloro(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane",78560-45-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b938da21-a82c-4233-946e-37c7c0784a31/documents/83b131eb-cb1b-4752-979f-f68f7a683c82_4700d377-b994-4223-a788-2ed4a55f8a02.html,Repeated dose toxicity – local effects,inhalation,NOAEC,< 10 ,adverse effect observed, "Trichloro(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane",78560-45-9,"There are no acute toxicity data for [2-(perfluorohexyl)ethyl]trichlorosilane (CAS 78560-45-9, EC 278-947-6).   In accordance with REACH Column 2 (Annexes VII and VIII), the acute toxicity tests (oral, inhalation, or dermal) do not need to be conducted since the substance is classified as corrosive to the skin.     ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b938da21-a82c-4233-946e-37c7c0784a31/documents/7c13aa23-5563-4f18-b398-5e67d64e6cee_4700d377-b994-4223-a788-2ed4a55f8a02.html,,,,,, Trichloro(3-chloropropyl)silane,2550-06-3,"No repeat-dose toxicity data are available for trichloro(3-chloropropyl)silane, therefore good quality data for the related substance trimethoxy(3-chloropropyl)silane have been read-across.Trimethoxy(3-chloropropyl)silane was tested in an inhalation OECD 422 study, whole-body in rats, up to and including the highest concentration of 100 ppm. In this study there were no signs of general toxicity. Therefore based on these results the NOAEC was established to be at least 100 ppm (867 mg/m3).In a 90-day inhalation study in rats, conducted in accordance with OECD 413, the NOEC for trimethoxy(3-chloropropyl)silane was determined to be 5 ppm (41 mg/m3) based on treatment-related histopathological effects observed in animals in 100 ppm treatment group. These were minimal/mild hyperplasia of the urinary bladder epithelium in both sexes (Dow Corning, 1993) and species specific changes in the kidneys. It is not known whether the urinary bladder was inflated by a fixative before microscopic examination; without inflation of the urinary bladder the relevance of the hyperplasia is questionable (Wanda M, 1991). There is no evidence for genotoxicity of CPTMO. Therefore, it is highly unlikely that the minimal /mild proliferative changes of the bladder are caused by a urinary bladder carcinogen. Based on the fact that the hyperplasia of the bladder was mild / minimal and associated with a minimal inflammation (cystitis) it can presumed that if the stimulus for the inflammation is removed the hyperplasia will resolve within a matter of weeks and the urinary bladder will return to a normal histological appearance (Wanda M, 1991). A minimal / mild reversible effect is not adverse. Therefore the NOAEC is considered to be greater than or equal to 100 ppm (867 mg/m3).The 90-day study was selected as the key study as it tested over the longest duration.Wanda M (1991). Handbook of Toxicologic Pathology, Edited by Wanda M. Haschek and Colin G. Rousseaux, Academic Press, INC., 1991 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b2fe5aa0-6c31-4cac-9126-6110cc9ad3e2/documents/IUC5-a7bdcc01-6961-4b30-aada-621b0038c3ca_7c85c6ba-2348-4c3b-aa88-61ac33c6f668.html,,,,,, Trichloro(3-chloropropyl)silane,2550-06-3,"The only available acute toxicity data is a Reliability 1 acute oral toxicity test in the rat, conducted in accordance with OECD 423 (Acute Toxic Class method) in male and female rats. The LD50 was determined to be in the range 200-2000 mg/kg bw. Clinical signs included reduced motility, ataxia, reduced muscle tone, and dyspnoea ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b2fe5aa0-6c31-4cac-9126-6110cc9ad3e2/documents/IUC5-7e0aba64-f055-4734-9694-4afd1cd23b10_7c85c6ba-2348-4c3b-aa88-61ac33c6f668.html,,,,,, Trichloro(ethyl)silane,115-21-9,"No adequate repeated dose toxicity data are available for trichloro(ethyl)silane, therefore data for the inhalation and oral routes have been read-across from the related substance, trimethoxy(methyl)silane, CAS 1185-55-3. Exposure to trimethoxy(methyl)silane (MTMS) was associated with organ weight and/or histomorphological changes in males (liver, thymus, thyroid, duodenum, jejunum, and red blood cell) and females (liver, thyroid, duodenum, jejunum, and adrenal gland) at dose levels at or above 250 mg/kg bw/day. A marked increase in prothrombin time was observed for males at 250 and 1000 mg/kg bw/day whereas females were unaffected. Exposure was also associated with increased blood platelet concentration for males and females at 1000 mg/kg bw/day. These data support a NOAEL for the toxicity phase of the study of 50 mg/kg bw/day.There is also a 90-day inhalation study on trimethoxy(methyl)silane. Based on the increased incidence of grossly observed urinary bladder calculi along with the kidney dilation at the 400 ppm exposure level, the No Observable Adverse Effect Level (NOAEL) for trimethoxy(methyl)silane vapor administered six hours per day, five days per week for a 90-day interval via whole-body inhalation exposure to male and female Sprague-Dawley rats, was 100 ppm (equivalent to 557.14 mg/m3).The key study (DCC, 2007) for repeated dose toxicity via the inhalation route, is a 90-day whole-body inhalation study, in which methyltrimethoxysilane was administered to rats six hours per day, five days per week. The NOAEC of 100 ppm (0.56 mg/l) was based on an increased incidence of grossly observed urinary bladder calculi along with kidney dilation at the 400 ppm exposure concentration. An oral OECD 422 screening test in rats is available for the substance methyltrimethoxysilane. The NOAEL for systemic effects was determined to be 50 mg/kg/day, based on findings in a number of organs including the liver and thymus gland. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/183f3be8-3bef-40f9-a909-d425f3a6e46b/documents/IUC5-5d81d305-7ab6-40a5-bf87-08f4cf197647_9413da28-035e-40cc-8171-9b4a1c6cc7f2.html,,,,,, Trichloro(ethyl)silane,115-21-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/183f3be8-3bef-40f9-a909-d425f3a6e46b/documents/IUC5-5d81d305-7ab6-40a5-bf87-08f4cf197647_9413da28-035e-40cc-8171-9b4a1c6cc7f2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,, Trichloro(ethyl)silane,115-21-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/183f3be8-3bef-40f9-a909-d425f3a6e46b/documents/IUC5-5d81d305-7ab6-40a5-bf87-08f4cf197647_9413da28-035e-40cc-8171-9b4a1c6cc7f2.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,560 mg/m3,, Trichloro(ethyl)silane,115-21-9,"The one-hour combined male/female LC50 (nominal concentrations) was determined to be 1257 ppm with 95% confidence limits of 1175-1320 ppm in rats (Dow Corning Corporation, 1997). There are no reliable data for the oral and dermal routes, and the corrosive nature of trichloro(ethyl)silane means that the acute oral toxicity study (required in Section 8.5.1) does not need to be conducted. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/183f3be8-3bef-40f9-a909-d425f3a6e46b/documents/IUC5-66acf680-9962-4a11-ac53-f65ee98a93b7_9413da28-035e-40cc-8171-9b4a1c6cc7f2.html,,,,,, Trichloro(ethyl)silane,115-21-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/183f3be8-3bef-40f9-a909-d425f3a6e46b/documents/IUC5-66acf680-9962-4a11-ac53-f65ee98a93b7_9413da28-035e-40cc-8171-9b4a1c6cc7f2.html,,inhalation,LC50,"4,200 mg/m3",, Trichloro(hexadecyl)silane,5894-60-0,"Repeated Dose 90-Day Oral Toxicity Study in Rodents (OECD 408), rat: NOAEL (systemic) >= 250 mg/kg bw/day NOAEL (local) = 40 mg/kg bw/day   Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): The study was well documented and meets generally accepted scientific principles, and conducted in compliance with GLP. The relevance of this data for hazard assessment of trichloro(hexadecyl)silane is discussed in the endpoint summary. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VIII - IX, 8.6, of Regulation (EC) No 1907/2006. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39d2c258-fb12-4ef1-b2f6-7082151ad742/documents/4bb70b76-025f-4eee-9dc4-6f5f21e063b0_2a743b7c-9a12-4b92-9050-fa05094fcab3.html,,,,,, Trichloro(hexadecyl)silane,5894-60-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39d2c258-fb12-4ef1-b2f6-7082151ad742/documents/4bb70b76-025f-4eee-9dc4-6f5f21e063b0_2a743b7c-9a12-4b92-9050-fa05094fcab3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Trichloro(hexadecyl)silane,5894-60-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/39d2c258-fb12-4ef1-b2f6-7082151ad742/documents/4bb70b76-025f-4eee-9dc4-6f5f21e063b0_2a743b7c-9a12-4b92-9050-fa05094fcab3.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 mg/m3,adverse effect observed,rat Trichloro(hexadecyl)silane,5894-60-0," Oral (OECD TG 423), rat: LD50 > 200 < 2000 mg/kg bw There are no acute toxicity data available by the dermal and inhalation route. However, in accordance with Column 2 of REACH Annexes VII and VIII, acute toxicity studies (required in Section 8.5) do not need to be conducted as the substance is classified as corrosive to skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/39d2c258-fb12-4ef1-b2f6-7082151ad742/documents/1fe2d9bd-8fc6-48d8-bde9-b6db4a9620b4_2a743b7c-9a12-4b92-9050-fa05094fcab3.html,,,,,, Trichloro(methyl)silane,75-79-6,"No data on the repeated dose toxicity of trichloro(methyl)silane are available, therefore data on methyltrimethoxysilane have been read-across. The basis for this read-across is that trichloro(methyl)silane and methyltrimethoxysilane are both rapidly hydrolysed to methylsilanetriol. Exposure to methyltrimethoxysilane (MTMS) was associated with organ weight and/or histomorphological changes in males (liver, thymus, thyroid, duodenum, jejunum, and red blood cell) and females (liver, thyroid, duodenum, jejunum, and adrenal gland) at dose levels at or above 250 mg/kg bw/day. A marked increase in prothrombin time was observed for males at 250 and 1000 mg/kg bw/day whereas females were unaffected. Exposure was also associated with increased blood platelet concentration for males and females at 1000 mg/kg bw/day. These data support a NOAEL for the toxicity phase of the study of 50 mg/kg bw/day. However, since trichloro(methyl)silane is corrosive, additional local effects can be expected for this substance. There is also a 90-day inhalation study on methyltrimethoxysilane that can be read-across to trichloro(methyl)silane. Based on the increased incidence of grossly observed urinary bladder calculi along with the kidney dilation at the 400 ppm exposure level, the No Observable Adverse Effect Level (NOAEL) for methyltrimethoxysilane vapor administered six hours per day, five days per week for a 90-day interval via whole-body inhalation exposure to male and female Sprague-Dawley rats, was 100 ppm (equivalent to 557.14 mg/m3) . However, since trichloro(methyl)silane is corrosive, additional local effects can be expected for this substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6e890f8-49e6-4048-a07a-d43a4851a8cf/documents/IUC5-605940dc-72f3-4158-b3f0-2109bcd2f6a1_d135b9db-5b94-4f6c-a516-12eddd6587e5.html,,,,,, Trichloro(methyl)silane,75-79-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6e890f8-49e6-4048-a07a-d43a4851a8cf/documents/IUC5-605940dc-72f3-4158-b3f0-2109bcd2f6a1_d135b9db-5b94-4f6c-a516-12eddd6587e5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,, Trichloro(methyl)silane,75-79-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c6e890f8-49e6-4048-a07a-d43a4851a8cf/documents/IUC5-605940dc-72f3-4158-b3f0-2109bcd2f6a1_d135b9db-5b94-4f6c-a516-12eddd6587e5.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,557.14 mg/m3,, Trichloro(methyl)silane,75-79-6,"The rat acute oral LD50 values were reported to be <0.25 ml/kg and <1 ml/kg for males and females, repectively in a key study for undiluted test material (BRRC 1981), equivalent to ca. <320 mg/kg bw in males. The key acute inhalation study (DCC 1997) reported a 1 hour LC50 value of 1365ppm (equivalent to 8.3 mg/l) and the acute dermal LD50 was 1804 mg/kg in males and 1076 mg/kg in females (BRRC 1981). The necropsy findings of the decedents identified distended and fluid filled stomachs and discoloured internal organs. All the key studies were well reported and conducted according to a test protocol that is comparable to the EU test method. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6e890f8-49e6-4048-a07a-d43a4851a8cf/documents/IUC5-26c6b54c-7676-443c-8ab9-30e15bcba8b9_d135b9db-5b94-4f6c-a516-12eddd6587e5.html,,,,,, Trichloro(methyl)silane,75-79-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6e890f8-49e6-4048-a07a-d43a4851a8cf/documents/IUC5-26c6b54c-7676-443c-8ab9-30e15bcba8b9_d135b9db-5b94-4f6c-a516-12eddd6587e5.html,,oral,LD50,320 mg/kg bw,, Trichloro(methyl)silane,75-79-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6e890f8-49e6-4048-a07a-d43a4851a8cf/documents/IUC5-26c6b54c-7676-443c-8ab9-30e15bcba8b9_d135b9db-5b94-4f6c-a516-12eddd6587e5.html,,dermal,LD50,"1,076 mg/kg bw",, Trichloro(methyl)silane,75-79-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c6e890f8-49e6-4048-a07a-d43a4851a8cf/documents/IUC5-26c6b54c-7676-443c-8ab9-30e15bcba8b9_d135b9db-5b94-4f6c-a516-12eddd6587e5.html,,inhalation,LC50,"8,345 mg/m3",, "Trichloro(N,N-dimethyloctylamine)boron",34762-90-8,    ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22646d30-9733-400c-9161-d02a2d9eca90/documents/IUC5-f3ddb1a9-8808-43a1-82cf-518ab98736e4_9ba7e194-95ed-4607-b222-19d4d5235323.html,,,,,, "Trichloro(N,N-dimethyloctylamine)boron",34762-90-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/22646d30-9733-400c-9161-d02a2d9eca90/documents/IUC5-f3ddb1a9-8808-43a1-82cf-518ab98736e4_9ba7e194-95ed-4607-b222-19d4d5235323.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Trichloro(N,N-dimethyloctylamine)boron",34762-90-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22646d30-9733-400c-9161-d02a2d9eca90/documents/IUC5-bed8294b-06b4-440c-ad32-49eb2d3a74a4_9ba7e194-95ed-4607-b222-19d4d5235323.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Trichloro(N,N-dimethyloctylamine)boron",34762-90-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/22646d30-9733-400c-9161-d02a2d9eca90/documents/IUC5-bed8294b-06b4-440c-ad32-49eb2d3a74a4_9ba7e194-95ed-4607-b222-19d4d5235323.html,,dermal,LD50,"2,500 mg/kg bw",no adverse effect observed, Trichloro(octadecyl)silane,112-04-9," No studies were available to assess the acute oral toxicity potential of dimethoxydimethylsilane (CAS: 1112-39-6), however, data are available for the structural analogue substances trimethoxymethylsilane (CAS: 1185-55-3) and triethoxymethylsilane (CAS: 2031-67-6), respectively. Oral: WoE approach CAS: 1185-55-3 and CAS: 2031-67-6: LD50 > 2000 mg/kg bw Inhalation: OECD TG 403: LC50 >4700 mg/m³ There are no data available for acute toxicity via the dermal route (data waiving according to Column 2 of REACH Annex VIII, Section 8.5.3). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77a693b7-6eab-4d89-99de-8df1cd536f04/documents/eb477789-f946-4618-80ca-4f316cb7f708_d40a3333-b6fb-4444-9fee-0874f8d559af.html,,,,,, Trichloro(octadecyl)silane,112-04-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77a693b7-6eab-4d89-99de-8df1cd536f04/documents/eb477789-f946-4618-80ca-4f316cb7f708_d40a3333-b6fb-4444-9fee-0874f8d559af.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Trichloro(octadecyl)silane,112-04-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/77a693b7-6eab-4d89-99de-8df1cd536f04/documents/eb477789-f946-4618-80ca-4f316cb7f708_d40a3333-b6fb-4444-9fee-0874f8d559af.html,,inhalation,discriminating conc.,"4,700 mg/m3",no adverse effect observed, Trichloro(phenyl)silane,98-13-5,"No repeat-dose toxicity data are available for trichloro(phenyl)silane, therefore good quality data for the related substance trimethoxy(phenyl)silane have been read-across.A well reported oral combined repeated dose/reproductive and developmental screening study (Harlan, 2009), conducted according to the current guideline and in accordance with GLP, did not identify an NOAEL for trimethoxy(phenyl)silane; effects to the urinary bladder were reported at the lowest tested dose of 100 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0f39bc7-6d66-4096-99b8-5de41126e3b6/documents/IUC5-36faad5f-deaf-484b-91fe-4f4649990f86_65dfae5e-d3fe-4a43-b49d-1faf97dacffa.html,,,,,, Trichloro(phenyl)silane,98-13-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a0f39bc7-6d66-4096-99b8-5de41126e3b6/documents/IUC5-36faad5f-deaf-484b-91fe-4f4649990f86_65dfae5e-d3fe-4a43-b49d-1faf97dacffa.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,, Trichloro(phenyl)silane,98-13-5,"No acute toxicity studies are available which meet current guideline requirements. However, further testing is not required as the substance is corrosive. Summary data which pre-dates GLP and OECD test guidlines report an oral LD50 of 2.4 g/kg in rats and a dermal LD50 of 0.9 ml/kg in rabbits (Mellon, 1951). Based on a relative density of 1.25, the LD50 (dermal) is 1125 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0f39bc7-6d66-4096-99b8-5de41126e3b6/documents/IUC5-87b3df1b-bbe1-483f-88e7-5896c89ce985_65dfae5e-d3fe-4a43-b49d-1faf97dacffa.html,,,,,, Trichloro(phenyl)silane,98-13-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0f39bc7-6d66-4096-99b8-5de41126e3b6/documents/IUC5-87b3df1b-bbe1-483f-88e7-5896c89ce985_65dfae5e-d3fe-4a43-b49d-1faf97dacffa.html,,oral,LD50,"2,400 mg/kg bw",, Trichloro(phenyl)silane,98-13-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a0f39bc7-6d66-4096-99b8-5de41126e3b6/documents/IUC5-87b3df1b-bbe1-483f-88e7-5896c89ce985_65dfae5e-d3fe-4a43-b49d-1faf97dacffa.html,,dermal,LD50,"1,125 mg/kg bw",, Trichloro(propyl)silane,141-57-1," There are no repeated dose oral, inhalation or dermal studies available for trichloro(propyl)silane. Data waivers are in place for oral and dermal repeated dose toxicity endpoints (see attachment to data waiver for repeated dose toxicity: oral). Trichloro(propyl)silane was tested in a 7-day dose range-finding study (non-GLP; Bioservice, 2018) in order to determine appropriate doses (to avoid corrosive effects) for administration in repeated dose toxicity tests. In this study a NOAEL could not be determined due to the corrosive effects of the test substance on the gastrointestinal and respiratory tracts. All animals administered the tests substance were sacrificed on study day 2 due to ethical reasons. The findings at pathology and histopathology showed signs of corrosion which was considered to be related to the hydrolysis product hydrochloric acid. A 14-day non-GLP dose range-finding study was conducted with trichloro(propyl)silane (CAS 141-57-1) based on guideline OECD 407 but modified to realise a staggered dose selection depending on substance related effects. Additional histopathology examinations were performed for precise NOAEL justification, but a NOAEL could not be determined. (Bioservice, 2019). In the study test item-related gross lesions were noted in the gastrointestinal organs at ≥ 175 mg/kg bw/day and these were evident during histopathological examination. At the microscopic examination, specific findings were found, starting at the dose of 50 mg/kg bw/day. These findings included inflammatory and degenerative lesions which consisted of erosions, inflammation, hyperplasia, ulceration, hyperkeratosis and mucosa atrophy. Since the local corrosive effects of chlorosilanes are significant, valid oral or inhalation studies according to the relevant guidelines are technically not feasible. It is also unlikely that any systemic effects would be observed at doses made sufficiently low to prevent the known corrosive effects and/or distress in the test species. Indeed, ECHA’s Executive Director made the following statement in his decision (No. ED/49/2015) for trichlorosilane “ECHA notes that the Contested Decision should not have provided the option of carrying out the PNDT study on the registered substance, which is corrosive and consequently can only be tested at very low concentrations. In a PNDT study, which normally requires high systematic availability of the tested substance, the very low concentrations would almost certainly lead to a negative result”.   To support this conclusion a 28-day inhalation study with another chlorosilane, dichloro(dimethyl)silane (CAS 75-78-5, WIL, 2014) is used to demonstrate that local effects are dominated by generation of the hydrolysis product, HCl, and that there are no adverse systemic effects.   In a well conducted 90-day gas inhalation study (Toxigenics, 1984) the systemic NOAEC for hydrogen chloride was 20 ppm based on decreased body weight following exposure to 50 ppm (6 hours/day, 5 days/week) in rats and mice. The main adverse findings related to irritant/corrosive effects on the nasal turbinates in mice, which was observed with a LOAEC of 10 ppm. A good quality 90-day repeated inhalation study for hydrogen chloride has been used to assess the local effects of trichloro(propyl)silane. In a 90-day repeated inhalation study with HCl, no serious adverse systemic effects were observed in rats and mice exposed up to 50 ppm (approximately 70 mg/m3) for 6 hours per day, 5 days per week. The only significant adverse finding relating to systemic toxicity was decreased body weight at the highest dose level. Local effects on the nasal turbinates of mice were observed at all dose levels tested (10, 20 and 50 ppm). Testing with HCl at higher test concentrations is neither ethically nor technically feasible since severe corrosive effects would lead to discomfort and distress in the test animals. The author of this CSR considers that the apparent systemic effects at 50 ppm in the study were most likely secondary to local corrosive effects at this dose level. Following uptake of HCl, hydrogen and chloride ions from will enter the body’s natural homeostatic processes and significant systemic effects are unlikely. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/474af9ae-dbf0-4f9e-941f-931de43ff943/documents/a56ea9b1-ba37-4f9d-9b51-fa4ca8380202_a4e45c1e-55ab-4f53-9dd3-c7558435c23f.html,,,,,, Trichloro(propyl)silane,141-57-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/474af9ae-dbf0-4f9e-941f-931de43ff943/documents/a56ea9b1-ba37-4f9d-9b51-fa4ca8380202_a4e45c1e-55ab-4f53-9dd3-c7558435c23f.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 mg/m3,adverse effect observed,rat Trichloro(propyl)silane,141-57-1," The key acute oral study was conducted according to OECD 423 (Acute Toxic Class method), giving an LD50 for male and female rats in the range > 200 - < 2000 mg/kg when dosed in corn oil (Laboratory of Pharmacology and Toxicology, 2002). Clinical signs observed included reduced motility, ataxia, reduced muscle tone, dyspnoea, lateral position and ptosis at the higher dose level. At the lower dose level no animals showed any signs of systemic toxicity. No abnormalities were found at macroscopic post mortem examination of the animals. The key acute inhalation study was conducted according to OECD 403, giving an LC50 of 1352 ppm  for one-hour, whole-body exposure (Dow Corning Corporation, 1997). Longer exposure times were not used due to the corrosivity of the test substance. Clinical signs and necropsy findings reflected the corrosive nature of the test substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/474af9ae-dbf0-4f9e-941f-931de43ff943/documents/ae2e173e-b15c-4520-9e2e-4f6551b83962_a4e45c1e-55ab-4f53-9dd3-c7558435c23f.html,,,,,, Trichloro(propyl)silane,141-57-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/474af9ae-dbf0-4f9e-941f-931de43ff943/documents/ae2e173e-b15c-4520-9e2e-4f6551b83962_a4e45c1e-55ab-4f53-9dd3-c7558435c23f.html,,oral,LD50,200 mg/kg bw,adverse effect observed, Trichloro(propyl)silane,141-57-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/474af9ae-dbf0-4f9e-941f-931de43ff943/documents/ae2e173e-b15c-4520-9e2e-4f6551b83962_a4e45c1e-55ab-4f53-9dd3-c7558435c23f.html,,inhalation,LC50,"5,000 mg/m3",adverse effect observed, Trichloro(vinyl)silane,75-94-5,"Repeated dose data are not available for trichloro(vinyl)silane (CAS 75-94-5, EC 200-917-8) or its rapidly formed silanol hydrolysis product vinylsilanetriol (CAS 143-48-6 / EC 864-795-3). Accordingly, the available data for its alkoxysilane analogues, trimethoxy(vinyl)silane (CAS 2768-02-7, EC 220-449-8) and triethoxy(vinyl)silane (CAS 78-08-0, EC 201-081-7), and its non-silanol hydrolysis product HCl (CAS 7647-01-0, CAS EC 231-595-7) are read across. For the oral route, the key data comprise the oral screening studies with the alkoxysilanes, with subchronic inhalation studies for HCl and trimethoxy(vinyl)silane also identified as key.    Oral route   In the key oral repeated dose study (combined repeated dose toxicity study with the reproduction / developmental toxicity screening test, conducted according to OECD Test Guideline 422 and in compliance with GLP (Hashima Laboratory, 2005, reliability 1), administration of alkoxysilane analogue trimethoxy(vinyl)silane (CAS 2768-02-7, EC 220-449-8) to rats at dose levels of 62.5, 250 or 1000 mg/kg bw/day lead to significant histopathological changes in the urinary bladder of males and females, which were not reversible at the end of the recovery period, in the higher dose groups of 250 and 1000 mg/kg bw/day. Administration of 62.5 mg/kg bw/day did not lead to organ damage including irreversible morphological effects permanently impairing the function of the organ/tissue (reversibility after recovery period). Also, no other effects such as necrosis or other cell death were reported, which could contribute to the degeneration of the metabolically functional tissue. The No Observed Adverse Effect Level (NOAEL) was therefore determined to be 62.5 mg/kg bw/day. The Lowest Observed Adverse Effect Level (LOAEL) was 250 mg/kg bw/day, based on the histopathological changes in the urinary bladder observed in all animals (males and females) at this dose level.   In the key oral screening study with alkoxysilane analogue triethoxy(vinyl)silane (CAS 78-08-0, 201-081-7), conducted according to OECD Test Guideline 422 and in compliance with GLP (BSL Bioservice Scientific Laboratories, 2022, reliability 1), Wistar rats were administered the test item daily via oral gavage at dose levels of 0, 62.5, 250 or 750 mg/kg bw/day (dried and de-acidified corn oil control / vehicle). Males were treated for 14-days pre-mating until a total of 29 days, with females treated for 14-days pre-mating up to Postnatal Day (PND) 12 in females. Based on multiple findings (lower body weight / body weight gain, lower food consumption, and adverse macro- / histopathology in the kidneys, urinary bladder, and ureters) from 250 mg/kg bw/day, the systemic NOAEL was identified as 62.5 mg/kg bw/day.   As a conservative approach for the oral CSA value for the registered substance (in the silanol hydrolysis product risk characterisation), the systemic NOAEL from the key extended one-generation reproductive toxicity study (EOGRTS) with alkoxysilane analogue trimethoxy(vinyl)silane (OECD Test Guideline 443 and GLP-compliant) is selected. As discussed in Section 5.9 Toxicity to reproduction and below, the NOAEL for systemic toxicity for the parental (P0 and P1 [F1 Cohort 1B]) animals was concluded to be 40 mg/kg bw/day based on adverse test item-related effects in the urinary system (kidney, bladder) at 100 and 300 mg/kg bw/day (BSL Bioservice Scientific Laboratories, 2021, reliability 1).   Inhalation route   In the key inhalation study with the HCl gas (CAS 7647-01-0, EC 231-595-7), conducted in a manner similar to OECD Test Guideline 413 and in compliance with GLP (Toxigenics Inc., 1984, reliability 2), the No Observed Adverse Effect Concentration (NOAEC) for systemic effects was determined to be 20 ppm (nominal) in rats and mice based on decreased body weight following exposure to 50 ppm HCl gas (nominal). A NOAEC for local effects was not established as irritant / corrosive effects were observed at all concentrations tested (i.e., from 10 ppm HCl gas).   In the key 14-week whole-body inhalation study (Bushy Run Research Center, 1990, reliability 1), conducted using a protocol similar to OECD Test Guideline 413 and in compliance with GLP, in which rats were exposed to nominal concentration of alkoxysilane analogue trimethoxy(vinyl)silane (CAS 2768-02-7, EC 220-449-8) at 10, 100 or 400 ppm, minimal to mild alterations in body weight, water consumption, urinalysis, organ weights, and bladder and kidney histopathology were observed at the highest concentration of 400 ppm. The clinical chemistry findings in males at 400 mg/kg bw/day (lower osmolarity and electrolyte concentrations, and decreased creatinine clearance) are consistent with the renal histopathology at this dose. At a concentration of 100 ppm there were some body weight gain reductions in females, but they were less than 10% and not always statistically significant, and there was no such finding in males; males had mild effects on urine osmolality and urine volume in week one only and there were no associated organ weight changes, macroscopic or microscopic findings. There were no findings at the end of the recovery period. Therefore, the findings at 100 ppm were concluded not to be adverse and the NOAEC in Fischer 344 rats was therefore 100 ppm (equivalent to 605 mg/m3 or 0.61 mg/l). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca4bc8d1-a842-48d2-9c73-4d632b9241c6/documents/e5ed2805-1fca-4086-ae19-5a3945da9ba6_0e1bb67f-7ca6-426c-bf82-e1d114d09702.html,,,,,, Trichloro(vinyl)silane,75-94-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca4bc8d1-a842-48d2-9c73-4d632b9241c6/documents/e5ed2805-1fca-4086-ae19-5a3945da9ba6_0e1bb67f-7ca6-426c-bf82-e1d114d09702.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,62.5 mg/kg bw/day,,rat Trichloro(vinyl)silane,75-94-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca4bc8d1-a842-48d2-9c73-4d632b9241c6/documents/e5ed2805-1fca-4086-ae19-5a3945da9ba6_0e1bb67f-7ca6-426c-bf82-e1d114d09702.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,100 ,, Trichloro(vinyl)silane,75-94-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca4bc8d1-a842-48d2-9c73-4d632b9241c6/documents/e5ed2805-1fca-4086-ae19-5a3945da9ba6_0e1bb67f-7ca6-426c-bf82-e1d114d09702.html,Repeated dose toxicity – local effects,inhalation,LOAEC,10 ,adverse effect observed, Trichloro(vinyl)silane,75-94-5,"In the key acute oral toxicity study with trichloro(vinyl)silane (CAS 75-94-5, EC 200-917-8) in the Wistar rat, conducted according to OECD Test Guideline 423 and in compliance with GLP (NOTOX, 2003, reliability 1), the oral LD50 was in the range of 200-2000 mg/kg bw.   In the key acute inhalation toxicity study with the registered substance in the Fischer 344 rat, conducted in a manner similar to OECD Test Guideline 403 and in compliance with GLP (Dow Corning Corporation, 2001, reliability 1), the 1-hour LC50 was 1611 ppm (nominal; approx. 10.6 mg/l). When this value is adjusted to reflect a 4-hour exposure, the estimated 4-hour LC50 is approx. 806 ppm or 5.3 mg/l.   In accordance with Column 2 of REACH Annex VIII (Section 8.5), the acute dermal toxicity test does not need to be conducted since trichloro(vinyl)silane is classified as corrosive to the skin. In addition, acute oral and inhalation data are available for the registered substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca4bc8d1-a842-48d2-9c73-4d632b9241c6/documents/524096db-e011-4fd8-a1be-bc908b7426a5_0e1bb67f-7ca6-426c-bf82-e1d114d09702.html,,,,,, Trichloro(vinyl)silane,75-94-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca4bc8d1-a842-48d2-9c73-4d632b9241c6/documents/524096db-e011-4fd8-a1be-bc908b7426a5_0e1bb67f-7ca6-426c-bf82-e1d114d09702.html,,oral,LD50,> 200 mg/kg bw,adverse effect observed, Trichloro(vinyl)silane,75-94-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca4bc8d1-a842-48d2-9c73-4d632b9241c6/documents/524096db-e011-4fd8-a1be-bc908b7426a5_0e1bb67f-7ca6-426c-bf82-e1d114d09702.html,,inhalation,LC50,5.3 mg/L,adverse effect observed, Trichloroacetaldehyde,75-87-6," Repeated dose toxicity: Oral A short-term toxicity study by the oral route does not need to be conducted because an appropriate inhalation study is available and inhalation is the most appropriate route of administration as based on the provided thorough and rigorous exposure assessment. Repeated dose toxicity: Inhalation The Low observed adverse effect concentration (LOAEC) for chloral is found to be 0.08 mg/L when exposed to male albino rats of Sprague Dawley strain for 14 days. Repeated dose toxicity: Dermal A short-term toxicity study does not need to be conducted because exposure of humans via dermal in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment. Also, the acute dermal toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Thus, it is expected that test chemical shall not exhibit 28 day repeated dose toxicity by the dermal route. In addition, there is no data available that suggests that test chemical shall exhibit repeated dose toxicity by the dermal route. Hence this end point was considered for waiver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0083221c-025b-4b45-8a8b-d927ff93190e/documents/9eccf0ae-c6f1-4a3b-8a6e-26cac80452d9_5b1cd2fe-b1df-4af8-9e78-27f364696323.html,,,,,, Trichloroacetaldehyde,75-87-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0083221c-025b-4b45-8a8b-d927ff93190e/documents/9eccf0ae-c6f1-4a3b-8a6e-26cac80452d9_5b1cd2fe-b1df-4af8-9e78-27f364696323.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,80 mg/m3,,rat Trichloroacetaldehyde,75-87-6," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats, mouse, rabbis and guinea pigs for the test chemical. The LD50 value is 850 mg/kg bw in rats. The study concluded that the LD50 value is between 300-2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value and range with the criteria of CLP regulation, the given test chemical can be classified in ‘Category 4’ for acute oral toxicity. Acute Inhalation Toxicity: The LC50 value is ≤0.5 mg/L, for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified in “Category 1” for acute inhalation toxicity. Acute Dermal toxicity: Acute dermal toxicity study was done in guinea pigs using test material.50% mortality observed at dose range 1510-15000 mg/kg, hence, LD50 was considered to be1510-15000 mg/kg body weight. When guinea pigs were treated with test chemical by dermal application. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0083221c-025b-4b45-8a8b-d927ff93190e/documents/0b5936f3-5865-4309-ab75-6cf8533532f2_5b1cd2fe-b1df-4af8-9e78-27f364696323.html,,,,,, Trichloroacetaldehyde,75-87-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0083221c-025b-4b45-8a8b-d927ff93190e/documents/0b5936f3-5865-4309-ab75-6cf8533532f2_5b1cd2fe-b1df-4af8-9e78-27f364696323.html,,oral,LD50,850 mg/kg bw,adverse effect observed, Trichloroacetaldehyde,75-87-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0083221c-025b-4b45-8a8b-d927ff93190e/documents/0b5936f3-5865-4309-ab75-6cf8533532f2_5b1cd2fe-b1df-4af8-9e78-27f364696323.html,,dermal,LD50,"1,510 mg/kg bw",no adverse effect observed, Trichloroacetaldehyde,75-87-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0083221c-025b-4b45-8a8b-d927ff93190e/documents/0b5936f3-5865-4309-ab75-6cf8533532f2_5b1cd2fe-b1df-4af8-9e78-27f364696323.html,,inhalation,LC50,0.44 mg/m3,adverse effect observed, Trichloroacetyl chloride,76-02-8," Acute oral toxicity:    The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is between 300 to 2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute oral toxicity 'category 4'.   Acute Inhalation Toxicity: The acute inhalation toxicity dose (LC50) was considered based on different studies conducted on rats for the test chemical. The LC50 value is <5 mg/l, for acute inhalation toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified for acute inhalation toxicity 'category 1'. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab7fab4e-f3c0-4689-9324-3d9fc1c544ed/documents/dc785aa1-635d-4714-8f24-5490fe74bee4_0f607ef9-5f66-4d3e-8a59-e2e83d073a4d.html,,,,,, Trichloroacetyl chloride,76-02-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab7fab4e-f3c0-4689-9324-3d9fc1c544ed/documents/dc785aa1-635d-4714-8f24-5490fe74bee4_0f607ef9-5f66-4d3e-8a59-e2e83d073a4d.html,,oral,LD50,600 mg/kg bw,no adverse effect observed, Trichloroacetyl chloride,76-02-8,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab7fab4e-f3c0-4689-9324-3d9fc1c544ed/documents/dc785aa1-635d-4714-8f24-5490fe74bee4_0f607ef9-5f66-4d3e-8a59-e2e83d073a4d.html,,inhalation,LC50,0.475 mg/m3,adverse effect observed, Trichloroisobutylsilane,18169-57-8,"No repeat-dose toxicity data are available for trichloroisobutylsilane, therefore good quality data have been read across from the related substance triethoxyisobutylsilane. The key repeated dose toxicity study was a 90-day nose-only inhalation study conducted in male and female rats, according to OECD 413. The study identified a NOAEC value of at least 2.54 mg/l (measured concentration), which was the highest dose tested. There were no significant treatment-related effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2c3f284-b33e-4152-8cd6-cdbdfb02fbe8/documents/IUC5-01f6350e-e640-4eb1-8f85-91752105e47d_e0c63b0b-1e2a-4954-ba4e-a2fd42aa03d7.html,,,,,, Trichloroisobutylsilane,18169-57-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2c3f284-b33e-4152-8cd6-cdbdfb02fbe8/documents/IUC5-01f6350e-e640-4eb1-8f85-91752105e47d_e0c63b0b-1e2a-4954-ba4e-a2fd42aa03d7.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"2,540 mg/m3",, Trichloroisobutylsilane,18169-57-8,"In the key oral toxicity study (Huls AG, 1993), the LD50 was determined to be 200 mg/kg and >200 mg/kg for male and female rats respectively. 4/4 animals died when dose at 2000 mg/kg. Necrospy findings were consistent with corrosive effects of the test substance. There are no data for the inhalation and dermal routes of exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2c3f284-b33e-4152-8cd6-cdbdfb02fbe8/documents/IUC5-bedef341-708b-46ed-a4e4-ac7ea80e23e5_e0c63b0b-1e2a-4954-ba4e-a2fd42aa03d7.html,,,,,, Trichloroisobutylsilane,18169-57-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2c3f284-b33e-4152-8cd6-cdbdfb02fbe8/documents/IUC5-bedef341-708b-46ed-a4e4-ac7ea80e23e5_e0c63b0b-1e2a-4954-ba4e-a2fd42aa03d7.html,,oral,LD50,200 mg/kg bw,, Trichloro-p-tolylsilane,701-35-9," There are no reliable acute toxicity data on the registered substance. However, in accordance with Column 2 of REACH Annexes VII and VIII, acute toxicity studies (required in Section 8.5) do not need to be conducted as the substance is classified as corrosive to skin. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3b64a6ad-6583-46f2-9f16-3601956033b4/documents/6fad1bae-d369-4c72-b3fa-1d2d3d321398_f2e55cf8-32d3-4e5d-afb7-1ab6236facad.html,,,,,, Trichlorosilane,10025-78-2," No data are available for the repeated dose oral toxicity of trichlorosilane therefore, good quality data for the precipitated hydrolysis product, synthetic amorphous silica (SAS) have been used to address the potential for systemic toxicity. In a repeat dose 90-day oral toxicity study (Kim et al., 2014) with Sprague-Dawley rats, two forms of synthetic amorphous silica (SAS and NM-202; differing in particle size and specific surface area) were administered (vehicle: water) by oral gavage for 90 consecutive days at a dose of 500, 1000 or 2000 mg/kg bw/day (10 animals/sex/group). The particles were described as either 20 or 100 nm in diameter. Extra animals were included in the control (received water only) and highest dose groups to allow for a two-week post-exposure recovery period. Observations were made according to OECD Test Guideline 408. For 20 and 100 nm silica samples the findings were sporadic and without a dose-response, so were concluded by the study authors to be not treatment-related. The NOAEL for both particle sizes was therefore concluded to be ≥2000 mg/kg bw/day. Since the local corrosive effects of chlorosilanes are significant, valid inhalation studies according to the relevant guidelines are technically not feasible. It is also unlikely that any systemic effects would be observed at doses made sufficiently low to prevent the known corrosive effects and/or distress in the test species. Indeed, ECHA’s Executive Director made the following statement in his decision (No. ED/49/2015) for trichlorosilane “ECHA notes that the Contested Decision should not have provided the option of carrying out the PNDT study on the registered substance, which is corrosive and consequently can only be tested at very low concentrations. In a PNDT study, which normally requires high systematic availability of the tested substance, the very low concentrations would almost certainly lead to a negative result”. To support this conclusion, a 28-day inhalation study with another chlorosilane, dichloro(dimethyl)silane (CAS 75-78-5, WIL, 2014) is used to demonstrate that local effects are dominated by generation of the hydrolysis product, HCl, and that there are no adverse systemic effects. For local effects, a good quality study on hydrogen chloride is available. In a 90-day repeated dose inhalation study in rats and mice (Toxigenics, 1984), 31 males and 21 females of each species/strain were exposed to test concentrations of 0, 10, 20 and 50 ppm hydrogen chloride gas (HCl). Treatment was whole-body exposure for six hours per day, 5 days per week. No serious adverse systemic effects were observed in rats and mice exposed up to 50 ppm (approximately 70 mg/m3) for 6 hours per day, 5 days per week. The only significant adverse finding relating to systemic toxicity was decreased body weight at the highest dose level. The No Observed Adverse Effect Concentration (NOAEC) for systemic effects was determined to be 20 ppm (approximately 30 mg/m3) based on decreased body weight following exposure to 50 ppm. Local effects on the nasal turbinates of mice were observed at all dose levels tested (10, 20 and 50 ppm). No NOAEC for local effects was established as irritant/corrosive effects were observed at all dose levels tested. Therefore, a LOAEC of 10 ppm was concluded. No suitable dermal data are available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5f2ad9e3-2983-429c-a362-1fc74419a51b/documents/06b77d68-e8a3-40ee-a4c1-d5b1b4bf0200_721ad2e6-e61c-4c52-8afb-8d8ff08fa895.html,,,,,, Trichlorosilane,10025-78-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5f2ad9e3-2983-429c-a362-1fc74419a51b/documents/06b77d68-e8a3-40ee-a4c1-d5b1b4bf0200_721ad2e6-e61c-4c52-8afb-8d8ff08fa895.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"2,000 mg/kg bw/day",,rat Trichlorosilane,10025-78-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5f2ad9e3-2983-429c-a362-1fc74419a51b/documents/06b77d68-e8a3-40ee-a4c1-d5b1b4bf0200_721ad2e6-e61c-4c52-8afb-8d8ff08fa895.html,Repeated dose toxicity – local effects,inhalation,LOAEC,15 mg/m3,adverse effect observed,rat Trichlorosilane,10025-78-2," In the key acute oral toxicity study for trichlorosilane, conducted according to a protocol similar to the now-deleted OECD Test Guideline 401 but pre-dating GLP, an LD50 value for male albino rats was concluded to be 1.03 (0.89 to 1.21) g/kg (equivalent to 1030 mg/kg bw/day) (Mellon Institute, 1948). No key acute inhalation or dermal toxicity studies are available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f2ad9e3-2983-429c-a362-1fc74419a51b/documents/139af195-ded9-4747-a9a5-0bd5bfc1820a_721ad2e6-e61c-4c52-8afb-8d8ff08fa895.html,,,,,, Trichlorosilane,10025-78-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5f2ad9e3-2983-429c-a362-1fc74419a51b/documents/139af195-ded9-4747-a9a5-0bd5bfc1820a_721ad2e6-e61c-4c52-8afb-8d8ff08fa895.html,,oral,LD50,"1,030 mg/kg bw",adverse effect observed, Trichromium dicarbide,12012-35-0,"Oral Repeated Dose Toxicity: No chronic repeated dose toxicity study with trichromium dicarbide is available. However, based on the information available and published in the context of the NTP program (Stout et al., 2010), two chronic repeated dose oral toxicity studies were conducted with chromium picolinate monohydrate using male and female F344/N rats and B6C3F1 mice. The substance was administered ad libitum to groups of 50 male and 50 female F344/N rats in feed at concentrations of 0, 2000, 10000 and 50000 ppm (actually ingested: males: approx. 0, 90, 460 and 2400 mg/kg bw/day; females: approx. 0, 100, 510 and 2630 mg/kg bw/day) for up to 105 weeks.   Average daily doses of Cr III, resulting from chromium picolinate monohydrate exposure in the present 3-month studies, ranged from approximately 1 to 500 mg/kg in rats and 2 to 1,500 mg/kg in mice. Average daily doses in the 2-year studies ranged from approximately 10 to 300 mg/kg in rats and 30 to 800 mg/kg in mice. These doses were up to five orders of magnitude higher than those consumed by humans ingesting typical doses of supplements. According to the authors, chromium picolinate monohydrate did not caused treatment-related effects on clinical signs, mortality, body weights, food consumption and histopathology (neoplastic/non-neoplastic).   No exposure-related lesions occurred in the 3-month studies on rats or mice. In the 2-year study no neoplasms or non- neoplastic lesions were attributed to exposure to chromium picolinate monohydrate.   This finding is supported by a sub-chronic oral repeated dose toxicity study with dichromium trioxide. Thereby, a second study (Ivankovic, 1975) for oral repeated dose toxicity was obtained from a study in which rats were fed chromium (III) oxide baked in bread for 90 days. No signs of toxicity were observed even at the highest dose (for males ca 1368 mg/kg/day and 1216 mg/kg/day for females).   Thereby, it was concluded using a read-across approach and considering the chromium measurement during the study, that chromium III does not present a health hazard to either sex.   Based on the findings from the 2 -year and 3-months studies, the NOEL (No-Observed-Effect-Level) of chromium picolinate monohydrate in male and female F344/N rats is considered to be > 50000 ppm (males and females : approx. equivalent to 300 mg Cr III/kg bw/) due to the absence of any relevant toxicological effects.   Based on the findings from the 2 -year and 3-months studies, the NOEL (No-Observed-Effect-Level) of chromium picolinate monohydrate in male and female B6C3F1 mice is considered to be > 50000 ppm (males and females: approx. equivalent to approx. 800 mg Cr III/kg bw/day) due to the absence of any relevant toxicological effects.   No adverse effects could be observed in none of these studies after the administration of chromium picolinate monohydrate and dichromium trioxide, respectively.   Inhalation Repeated Dose Toxicity: The LOAEC for inhalation was derived from a guideline subchronic inhalation study with chromium(III) oxide. At the lowest concentration slight inflammation was observed in the lungs.   Dermal Repeated Dose Toxicity: Due to the low bioavailability of chromium, the dermal route is not relevant for repeated dose toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea40d040-0192-4154-a390-3ae4d4fb5def/documents/e16f95e0-86d7-4c08-84df-e899b2eb334b_62215de2-df58-4a7a-9cac-f9fe4302e673.html,,,,,, Trichromium dicarbide,12012-35-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea40d040-0192-4154-a390-3ae4d4fb5def/documents/e16f95e0-86d7-4c08-84df-e899b2eb334b_62215de2-df58-4a7a-9cac-f9fe4302e673.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,368 mg/kg bw/day",, Trichromium dicarbide,12012-35-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ea40d040-0192-4154-a390-3ae4d4fb5def/documents/e16f95e0-86d7-4c08-84df-e899b2eb334b_62215de2-df58-4a7a-9cac-f9fe4302e673.html,Short-term repeated dose toxicity – systemic effects,inhalation,LOAEC,3 mg/m3,, Trichromium dicarbide,12012-35-0,"An acute oral toxicity test indicated an LD50 > 5000 mg/kg for chromium(III) oxide, corresponding to ca 3400 mg Cr/kg bw. LC50 for acute inhalation toxicity is >5.41 mg/L (5410 mg/m3) air (analytical). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea40d040-0192-4154-a390-3ae4d4fb5def/documents/bf5b1b1b-8804-4f25-815e-598bbdddd343_62215de2-df58-4a7a-9cac-f9fe4302e673.html,,,,,, Trichromium dicarbide,12012-35-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea40d040-0192-4154-a390-3ae4d4fb5def/documents/bf5b1b1b-8804-4f25-815e-598bbdddd343_62215de2-df58-4a7a-9cac-f9fe4302e673.html,,oral,LD50,"3,400 mg/kg bw",, Trichromium dicarbide,12012-35-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ea40d040-0192-4154-a390-3ae4d4fb5def/documents/bf5b1b1b-8804-4f25-815e-598bbdddd343_62215de2-df58-4a7a-9cac-f9fe4302e673.html,,inhalation,LC50,"5,410 mg/m3",, Tricobalt dicitrate,866-81-9,"No NOAECs were identified, neither for rats nor for mice.LOAEC (local, rat): 0.37 mg/m3 (Tricobalt dicitrate; recalculated value)LOAEC (local, mouse): 0.37 mg/m3 (Tricobalt dicitrate; recalculated value) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/10a308b6-8aca-4cb6-bff4-310bf40cf4ea/documents/IUC5-bb19cd60-737e-441d-bcfb-e9f1aceb385f_e994a073-bda8-4f70-9fc9-831d0b1d19f5.html,,,,,, Tricobalt dicitrate,866-81-9,Oral: LD50 (rat) = 503 mg/kg bw (Tricobalt dicitrate; recalculated value from cobalt(II)sulfate heptahydrate) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10a308b6-8aca-4cb6-bff4-310bf40cf4ea/documents/IUC5-633eb114-768b-44ba-8342-86e3030286be_e994a073-bda8-4f70-9fc9-831d0b1d19f5.html,,,,,, Tricobalt tetraoxide,1308-06-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): key study available ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d5d16da-4c1a-4cfc-ac0a-370f80020e96/documents/6eb78115-cb03-40de-9df4-fd88e23d68c0_5a8be34f-6c48-4036-a064-9aecd057f1c3.html,,,,,, Tricobalt tetraoxide,1308-06-1,"Acute oral toxicity:LD50(rat)> 5000 mg tricobalt tetraoxide/kg bwAcute dermal toxicity:Conduct of an acute dermal toxicity study for tricobalt tetraoxide is unjustified since dermal uptake is considered negligible.Acute inhalation toxicity:LC50 (male and female rats, 4 hours) > 5.06 mg/L air ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d5d16da-4c1a-4cfc-ac0a-370f80020e96/documents/IUC5-c317515b-d7f2-41c9-8065-639fd50921a0_5a8be34f-6c48-4036-a064-9aecd057f1c3.html,,,,,, "Tricyclo[3.3.1.13,7]decan-1-aminium, N,N,N-trimethyl-, hydroxide (1:1)",53075-09-5,"LD50, rat, oral > 300 < 2000 mg/kg bw (BASF SE, 2008) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/835eccc5-e9a9-4b50-bcdb-e894ebfff174/documents/IUC5-a2c73fc5-6a60-40b5-88f2-fc9f8958d4e4_8ed820d3-2913-44ef-97b4-a5e1c1f00dbc.html,,,,,, "Tricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene",1633-22-3," A 28-day repeated dose study by oral route in rats has been carried out in order to evaluate the toxicity of DPX-C after repeated exposure. Based on the findings of this study, it is concluded that the DPX-C (Di-Cloro-Di-p-Xililene) did not produce any toxicity or adverse effect at dose level 50 mg/kg b. wt./day when administered orally through gavage for 28 consecutive days, but it produces toxic effects at higher doses. Therefore, the No Observed Adverse Effect Level (NOAEL) of DPX-C (Di-Cloro-Di-p-Xililene) is 50 mg/kg b. wt./day. At higher doses effects on body weight and organ weights (kidney, liver, heart, brain, prostate, seminal vesicles, thyroid and parathyroid) were observed. Moreover, biochemical effects and effects on the produced urine were observed. There were histopathological lesions in kidneys and enlargement of liver associated with hypertrophy of hepatocyte (centriolobular and/or diffuse). In addition, follicular hypertrophy (thyroid) and hyaline droplets accumulation in cortical tubules in kidneys was observed. All dose groups showed minimal to mild severity of basophilic/ regenerating tubules in the cortex. However, some of the effects observed at the end of treatment were continued with reduced severity after recovery period. Other effects were almost completely recovered after ceasing the treatment. No studies by dermal and inhalation routes of exposure were performed, because exposure of humans via dermal / inhalation routes in production and or use is not likely as based on the provided thorough and rigorous exposure assessment . Therefore information by oral route was considered enough to sufficiently characterize the hazard of the substance. According to a read-across approach (see justification of the read-across approach between endpoints of DPX-C and Dibenzetano), data obtained for DPX-C applies also to Dibenzetano. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6bfb2c8-b78b-4aed-af17-cccba37f9c0f/documents/cceb20cb-b75e-455d-a279-4153eb0faa0c_6bcf77f6-ab13-4e88-9e37-2774081b11cf.html,,,,,, "Tricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene",1633-22-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6bfb2c8-b78b-4aed-af17-cccba37f9c0f/documents/cceb20cb-b75e-455d-a279-4153eb0faa0c_6bcf77f6-ab13-4e88-9e37-2774081b11cf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Tricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene",1633-22-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6bfb2c8-b78b-4aed-af17-cccba37f9c0f/documents/caf053a2-6f51-41f8-a07a-6f7bc3bbc084_6bcf77f6-ab13-4e88-9e37-2774081b11cf.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Tricyclo[8.2.2.24,7]hexadeca-1(12),4,6,10,13,15-hexaene",1633-22-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6bfb2c8-b78b-4aed-af17-cccba37f9c0f/documents/caf053a2-6f51-41f8-a07a-6f7bc3bbc084_6bcf77f6-ab13-4e88-9e37-2774081b11cf.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "Trideca-1,1,1,2,2,3,3,4,4,5,5,6,6-fluorohexane",355-37-3," Two key guideline (OECD 407, 421) studies that investigated the repeated dose toxicity potential of 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorohexane following oral exposure (gavage) in rats are available. The results are summarized below:   OECD 407 The oral repeated-dose toxicity NOEL for 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorohexane was considered to be 200 mg/Kg/day, based on increased liver weights observed in male rats exposed to the test material at 1000 mg/Kg/day for 28 days.   OECD 421 The oral repeated-dose toxicity NOAEL for 1,1,1,2,2,3,3,4,4,5,5,6,6-tridecafluorohexane was determined to be at least 1000 mg/Kg, based on lack of adverse treatment-related effects observed at the highest dose tested, and after a maximum of 64 days exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be98baf3-19cf-44f3-bf6a-4dce4a0286af/documents/bd6be3d0-5bb1-4a99-bb69-4bf1a8d846eb_87724e09-1e9b-4b13-9e55-0b5491c9f134.html,,,,,, "Trideca-1,1,1,2,2,3,3,4,4,5,5,6,6-fluorohexane",355-37-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/be98baf3-19cf-44f3-bf6a-4dce4a0286af/documents/bd6be3d0-5bb1-4a99-bb69-4bf1a8d846eb_87724e09-1e9b-4b13-9e55-0b5491c9f134.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Trideca-1,1,1,2,2,3,3,4,4,5,5,6,6-fluorohexane",355-37-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be98baf3-19cf-44f3-bf6a-4dce4a0286af/documents/0f439a1c-c7c6-4568-8c38-84d9293fdb83_87724e09-1e9b-4b13-9e55-0b5491c9f134.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Trideca-1,1,1,2,2,3,3,4,4,5,5,6,6-fluorohexane",355-37-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/be98baf3-19cf-44f3-bf6a-4dce4a0286af/documents/0f439a1c-c7c6-4568-8c38-84d9293fdb83_87724e09-1e9b-4b13-9e55-0b5491c9f134.html,,inhalation,LC50,145.3 mg/m3,no adverse effect observed, "Tridecanamine, N-tridecyl-, branched and linear",101012-97-9,"Repeated dose toxicity - oral: Key: LOAEL (general systemic toxicity) = 50 mg/kg bw/d based on general signs of systemic toxicity, including clinical chemistry and a variety of (histo-)pathological changes down to the low-dose, rat, OECD 422, GLP-compliant, 2023, K1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0515320b-0c4d-4d41-9c29-66afda92ea0e/documents/e06e9efb-0b93-42bc-bd4d-af2208d3091f_99738403-104d-41f1-ba22-f787e640fde8.html,,,,,, "Tridecanamine, N-tridecyl-, branched and linear",101012-97-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0515320b-0c4d-4d41-9c29-66afda92ea0e/documents/e06e9efb-0b93-42bc-bd4d-af2208d3091f_99738403-104d-41f1-ba22-f787e640fde8.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,50 mg/kg bw/day,,rat "Tridecanamine, N-tridecyl-, branched and linear",101012-97-9,"Acute toxicity: oral Key: LD50 = 2700 mg/kg bw, rat, similar to OECD 401, non-GLP, 1970, K2   Acute toxicity: inhalation Key: no LC50 value derived, no mortality observed, rat, similar to OECD 403 (inhalation-risk test), non-GLP, 1970, K2   Acute toxicity: dermal no data available ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0515320b-0c4d-4d41-9c29-66afda92ea0e/documents/IUC5-96f7867f-5edf-41cb-af00-755256769f78_99738403-104d-41f1-ba22-f787e640fde8.html,,,,,, "Tridecanamine, N-tridecyl-, branched and linear",101012-97-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0515320b-0c4d-4d41-9c29-66afda92ea0e/documents/IUC5-96f7867f-5edf-41cb-af00-755256769f78_99738403-104d-41f1-ba22-f787e640fde8.html,,oral,discriminating dose,"2,700 mg/kg bw",no adverse effect observed, Tridecanedioic acid,505-52-2,"Read across from dodecanedioic acid (CAS 693-23-2) - Subchronic NOAEL (rat): 1800 mg/kg bw/day (OECD 408, GLP) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11861b16-ee1d-4204-8772-0022dc7272a3/documents/IUC5-e789b435-de74-416d-807a-f171983bbeb8_423fdaf6-6768-48cb-8b2e-d9e6cdc23110.html,,,,,, Tridecanedioic acid,505-52-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/11861b16-ee1d-4204-8772-0022dc7272a3/documents/IUC5-e789b435-de74-416d-807a-f171983bbeb8_423fdaf6-6768-48cb-8b2e-d9e6cdc23110.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,800 mg/kg bw/day",,rat Tridecanedioic acid,505-52-2,Oral toxicity - LD50 (females): > 2000 mg/kg bw (OECD 423; GLP)Dermal toxicity - LD50 (males/females): > 2000 mg/kg bw (OECD 402; GLP) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11861b16-ee1d-4204-8772-0022dc7272a3/documents/IUC5-e07c693d-1589-4257-a0a8-dd7f116c9ee9_423fdaf6-6768-48cb-8b2e-d9e6cdc23110.html,,,,,, Tridecanedioic acid,505-52-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11861b16-ee1d-4204-8772-0022dc7272a3/documents/IUC5-e07c693d-1589-4257-a0a8-dd7f116c9ee9_423fdaf6-6768-48cb-8b2e-d9e6cdc23110.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tridecanedioic acid,505-52-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/11861b16-ee1d-4204-8772-0022dc7272a3/documents/IUC5-e07c693d-1589-4257-a0a8-dd7f116c9ee9_423fdaf6-6768-48cb-8b2e-d9e6cdc23110.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Triethoxy(2,4,4-trimethylpentyl)silane",35435-21-3," In the 90-day oral repeated dose toxicity study, conducted according to OECD Test Guideline 408 and in compliance with GLP, a systemic NOAEL of 150 mg/kg bw/day was concluded based on no treatment-related effects in any of the test animals (BSL Bioservice, 2015). There are no repeated dose inhalation toxicity data on triethoxy(2,4,4-trimethylpentyl)silane, so good quality data for the structural analogue trimethoxy(2,4,4-trimethylpentyl)silane (CAS 34396-03-7), have been used to assess the repeated dose inhalation toxicity of triethoxy(2,4,4-trimethylpentyl)silane. In the 28-day inhalation repeated dose toxicity study with triethoxy(2,4,4-trimethylpentyl)silane, conducted according to OECD Test Guideline 412 and in compliance with GLP, the NOAEL for systemic toxicity was concluded to be at least 3 mg/l (nominal) based no adverse systemic effects (Hoechst Pharma Forschung Toxikologie und Pathologie, 1986b). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b83fa88e-99e8-45dc-b55d-82d89587de57/documents/e79c5338-0350-4d83-acc5-c4a9fd60d9a4_1f4c9493-67eb-4035-a323-f23c8752e5e9.html,,,,,, "Triethoxy(2,4,4-trimethylpentyl)silane",35435-21-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b83fa88e-99e8-45dc-b55d-82d89587de57/documents/e79c5338-0350-4d83-acc5-c4a9fd60d9a4_1f4c9493-67eb-4035-a323-f23c8752e5e9.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"3,000 mg/m3",,rat "Triethoxy(2,4,4-trimethylpentyl)silane",35435-21-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b83fa88e-99e8-45dc-b55d-82d89587de57/documents/e79c5338-0350-4d83-acc5-c4a9fd60d9a4_1f4c9493-67eb-4035-a323-f23c8752e5e9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Triethoxy(2,4,4-trimethylpentyl)silane",35435-21-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b83fa88e-99e8-45dc-b55d-82d89587de57/documents/e79c5338-0350-4d83-acc5-c4a9fd60d9a4_1f4c9493-67eb-4035-a323-f23c8752e5e9.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"3,000 mg/m3",no adverse effect observed,rat "Triethoxy(2,4,4-trimethylpentyl)silane",35435-21-3," In the key acute oral toxicity study, conducted according to OECD Test Guideline 423 and in compliance with GLP, the LD50 for triethoxy(2,4,4-trimethylpentyl)silane was concluded to be > 2000 mg/kg bw. No deaths occurred up to the highest dose tested (Research and Consulting Company Ltd., 1998). In the key acute dermal toxicity study, conducted according to OECD Test Guideline 402 and in compliance with GLP, the LD50 for triethoxy(2,4,4-trimethylpentyl)silane was concluded to be > 2000 mg/kg bw (BSL Bioservice, 2001a). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b83fa88e-99e8-45dc-b55d-82d89587de57/documents/c12e1728-bb79-46bd-98b3-b796d22a6e21_1f4c9493-67eb-4035-a323-f23c8752e5e9.html,,,,,, "Triethoxy(2,4,4-trimethylpentyl)silane",35435-21-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b83fa88e-99e8-45dc-b55d-82d89587de57/documents/c12e1728-bb79-46bd-98b3-b796d22a6e21_1f4c9493-67eb-4035-a323-f23c8752e5e9.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Triethoxy(2,4,4-trimethylpentyl)silane",35435-21-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b83fa88e-99e8-45dc-b55d-82d89587de57/documents/c12e1728-bb79-46bd-98b3-b796d22a6e21_1f4c9493-67eb-4035-a323-f23c8752e5e9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Triethoxy(3-isocyanatopropyl)silane,24801-88-5,"There are no repeated dose toxicity data on triethoxy(3-isocyanatopropyl)silane (CAS 24801-88-5, EC 246-467-6) so data for the intermediate hydrolysis product, 3-aminopropyl(triethoxy)silane (CAS 919-30-2, EC 213-048-4), have been used for this endpoint.   The key 90-day oral repeated dose toxicity study in male and female rats with the intermediate hydrolysis product, 3-aminopropyl(triethoxy)silane (CAS 919-30-2), was conducted according to OECD Test Guideline 408 and in compliance with GLP. The study identified a NOAEL value of 200 mg/kg bw/day, with mortality, clinical findings and liver effects at the LOAEL of 600 mg/kg bw/day (WIL, 2001, reliability 1). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f40de06c-214d-4727-8b1d-47ace8167b43/documents/11b242b6-18b6-4917-925f-370904630593_cfacb598-7df9-438b-bdff-f9ce947b61c5.html,,,,,, Triethoxy(3-isocyanatopropyl)silane,24801-88-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f40de06c-214d-4727-8b1d-47ace8167b43/documents/11b242b6-18b6-4917-925f-370904630593_cfacb598-7df9-438b-bdff-f9ce947b61c5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Triethoxy(3-isocyanatopropyl)silane,24801-88-5,"In the key acute oral toxicity study, conducted according to OECD Test Guideline 423 and in compliance with GLP, an LD50 value in the range of 300 and 500 mg/kg bw was concluded for triethoxy(3-isocyanatopropyl)silane (CAS 24801-88-5, EC 246-467-6; Safepharm Laboratories, 2003, reliability 1).   In the key acute dermal toxicity study, which pre-dated GLP but was conducted according to a guideline similar to OECD Test Guideline 402, an LD50 value of 1261 mg/kg bw was concluded (Chem Hygiene Fellowship, 1973c, reliability 2).   An acute inhalation study (Chem Hygiene Fellowship, 1973b, reliability 4) with the registered substance is included because the effects seen are consistent with the severe local effects on the respiratory tract expected for this substance and support the proposed classification for acute inhalation toxicity.  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f40de06c-214d-4727-8b1d-47ace8167b43/documents/2dd22ac0-3cbd-4c90-8c54-7d448d8fe012_cfacb598-7df9-438b-bdff-f9ce947b61c5.html,,,,,, Triethoxy(3-isocyanatopropyl)silane,24801-88-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f40de06c-214d-4727-8b1d-47ace8167b43/documents/2dd22ac0-3cbd-4c90-8c54-7d448d8fe012_cfacb598-7df9-438b-bdff-f9ce947b61c5.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Triethoxy(3-isocyanatopropyl)silane,24801-88-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f40de06c-214d-4727-8b1d-47ace8167b43/documents/2dd22ac0-3cbd-4c90-8c54-7d448d8fe012_cfacb598-7df9-438b-bdff-f9ce947b61c5.html,,dermal,LD50,"1,261 mg/kg bw",adverse effect observed, Triethoxy(3-isocyanatopropyl)silane,24801-88-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f40de06c-214d-4727-8b1d-47ace8167b43/documents/2dd22ac0-3cbd-4c90-8c54-7d448d8fe012_cfacb598-7df9-438b-bdff-f9ce947b61c5.html,,inhalation,LC50,360 mg/m3,adverse effect observed, Triethoxy(3-thiocyanatopropyl)silane,34708-08-2,"In the key study conducted according to OECD Test Guideline 408 and in compliance with GLP (Charles River Laboratories, 2022, reliability score 1), Wistar Han rats were administered triethoxy(3-thiocyanatopropyl)silane (CAS No. 34708-08-2, EC No. 252-161-3) at 0, 30, 100, and 300 mg/kg bw/day via oral gavage (arachis oil vehicle) for 7 days/week over 13 weeks. The systemic NOAEL for triethoxy(3-thiocyanatopropyl)silane was 100 mg/kg bw/day, based on effects in males (decreased body weight, body weight gain, and food consumption) and females (increased renal organ weight and related histopathological alterations) at 300 mg/kg bw/day. For local effects in the non-glandular stomach, the NOAEL was 30 mg/kg bw/day.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da7b7a78-21eb-4903-9e44-f29f0dce13df/documents/03c4dfa4-c73b-4c32-82db-043e233d0a8b_34f82a32-6ef5-4c38-86dc-ae7a395167ce.html,,,,,, Triethoxy(3-thiocyanatopropyl)silane,34708-08-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da7b7a78-21eb-4903-9e44-f29f0dce13df/documents/03c4dfa4-c73b-4c32-82db-043e233d0a8b_34f82a32-6ef5-4c38-86dc-ae7a395167ce.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Triethoxy(3-thiocyanatopropyl)silane,34708-08-2,"The key study for acute oral toxicity of triethoxy(3-thiocyanatopropyl)silane (CAS No. 34708-08-2, EC No. 252-161-3) found the test substance harmful, when administered via oral gavage to rats, with an acute oral LD50s of 986 (male), 1650 (female) and 1423 mg/kg bw (males and females) calculated. The male / female LD50 is selected as the key value. The study was performed in accordance with OECD Test Guideline 401 but not in compliance with GLP (ASTA Pharma AG, 1987, reliability score 2).   The key study for acute dermal toxicity reports an LD50 value of >4000 mg/kg bw, which was determined in a study conducted according to OECD Test Guideline 402 and in compliance with GLP (Harlan Laboratories Ltd., 2011, reliability score 1).   In accordance with Column 2 of REACH Annex VIII, an acute toxicity study via the inhalation route (required in Section 8.5.2) does not need to be conducted as reliable data via the oral and dermal routes are available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da7b7a78-21eb-4903-9e44-f29f0dce13df/documents/8ad968a1-bfdd-4799-a484-01842e54c6fd_34f82a32-6ef5-4c38-86dc-ae7a395167ce.html,,,,,, Triethoxy(3-thiocyanatopropyl)silane,34708-08-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da7b7a78-21eb-4903-9e44-f29f0dce13df/documents/8ad968a1-bfdd-4799-a484-01842e54c6fd_34f82a32-6ef5-4c38-86dc-ae7a395167ce.html,,oral,LD50,"1,423 mg/kg bw",adverse effect observed, Triethoxy(3-thiocyanatopropyl)silane,34708-08-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da7b7a78-21eb-4903-9e44-f29f0dce13df/documents/8ad968a1-bfdd-4799-a484-01842e54c6fd_34f82a32-6ef5-4c38-86dc-ae7a395167ce.html,,dermal,LD50,"> 4,000 mg/kg bw",no adverse effect observed, Triethoxy(phenyl)silane,780-69-8, Oral (subacute): Repeated dose toxicity: OECD TG 422 in rats: NOAEL = 40 mg/kg bw/day. Inhalation (subacute): Repeated dose toxicity: OECD TG 412 in rats: NOAEC > 620 mg/m³. No systemic toxicity was observed after repeated exposure to concentrations up to 620 mg/m³. Dermal toxicity: no measured data are available ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a1a4fa9-7320-4b8c-99d1-25afec74432b/documents/89056fd7-b19d-4e06-a4d7-577c06efb7b6_9778ba24-0064-49e5-8d46-224eb31e1119.html,,,,,, Triethoxy(phenyl)silane,780-69-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a1a4fa9-7320-4b8c-99d1-25afec74432b/documents/89056fd7-b19d-4e06-a4d7-577c06efb7b6_9778ba24-0064-49e5-8d46-224eb31e1119.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat Triethoxy(phenyl)silane,780-69-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a1a4fa9-7320-4b8c-99d1-25afec74432b/documents/89056fd7-b19d-4e06-a4d7-577c06efb7b6_9778ba24-0064-49e5-8d46-224eb31e1119.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,620 mg/m3,,rat Triethoxy(phenyl)silane,780-69-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a1a4fa9-7320-4b8c-99d1-25afec74432b/documents/89056fd7-b19d-4e06-a4d7-577c06efb7b6_9778ba24-0064-49e5-8d46-224eb31e1119.html,Repeated dose toxicity – local effects,inhalation,NOAEC,620 mg/m3,no adverse effect observed,rat Triethoxy(phenyl)silane,780-69-8," Acute toxicity: Oral (similar to OECD 401, no GLP, RL2), rat: LD50=2.83 ml/kg bw (corresponding to 2802 mg/kg bw) (Carpenter et al., 1974) Dermal (similar to OECD 402, no GLP, RL2), rabbit: LD50=3.18 ml/kg bw (corresponding to 3014 mg/kg bw) Inhalation: There are no acute inhalation data. In accordance with Column 2 of REACH Annex VIII, the acute toxicity study via the inhalation route (required in Section 8.5.2) does not need to be conducted as reliable data via the oral and dermal routes are available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a1a4fa9-7320-4b8c-99d1-25afec74432b/documents/55ee57a8-957b-42bf-94a4-382af1cc8f49_9778ba24-0064-49e5-8d46-224eb31e1119.html,,,,,, Triethoxy(phenyl)silane,780-69-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a1a4fa9-7320-4b8c-99d1-25afec74432b/documents/55ee57a8-957b-42bf-94a4-382af1cc8f49_9778ba24-0064-49e5-8d46-224eb31e1119.html,,oral,LD50,"2,802 mg/kg bw",no adverse effect observed, Triethoxy(phenyl)silane,780-69-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a1a4fa9-7320-4b8c-99d1-25afec74432b/documents/55ee57a8-957b-42bf-94a4-382af1cc8f49_9778ba24-0064-49e5-8d46-224eb31e1119.html,,dermal,LD50,"3,014 mg/kg bw",no adverse effect observed, Triethoxyhexadecylsilane,16415-13-7, No data in order to evaluate repeated dose toxicity of the registered substance are available. A testing proposal for a 90 -day study according to OECD TG 408 is submitted for the structural analogue substance hexadecyl(trimethoxy)silane (16415-12-6). As soon these data is available they will be included in the dossier. In the mean time a qualitative risk assessment will be performed. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc1d2c7d-9591-4f20-9230-830ed52a0513/documents/a7dd7bd4-c655-4d82-ad8a-811ac2e0e1f8_d26aa9c1-de04-4898-8d5d-6b43cfc400c9.html,,,,,, Triethoxyhexadecylsilane,16415-13-7,"Oral (OECD 423, rat): LD50 >2000 mg/kg bw (RA from CAS 16415-12-6)Inhalation: No data availableDermal (OECD 402, rat): LD50 >2000 mg/kg bw ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc1d2c7d-9591-4f20-9230-830ed52a0513/documents/756d2557-c72e-4c7b-a69a-3719c38e4757_d26aa9c1-de04-4898-8d5d-6b43cfc400c9.html,,,,,, Triethoxyhexadecylsilane,16415-13-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc1d2c7d-9591-4f20-9230-830ed52a0513/documents/756d2557-c72e-4c7b-a69a-3719c38e4757_d26aa9c1-de04-4898-8d5d-6b43cfc400c9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Triethoxyhexadecylsilane,16415-13-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc1d2c7d-9591-4f20-9230-830ed52a0513/documents/756d2557-c72e-4c7b-a69a-3719c38e4757_d26aa9c1-de04-4898-8d5d-6b43cfc400c9.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Triethoxypropylsilane,2550-02-9," Inhalation (OECD TG 413), rat: NOAEC (males) ≥ 2500 mg/m³, NOEC (females) ≥ 2500 mg/m³ ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c02ef0b-279b-4b72-838d-192dd9819106/documents/504bc74b-05ff-49ed-8bb5-174de350b7e3_b94a43c2-7c72-4a99-bbc4-39948e62a7b3.html,,,,,, Triethoxypropylsilane,2550-02-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c02ef0b-279b-4b72-838d-192dd9819106/documents/504bc74b-05ff-49ed-8bb5-174de350b7e3_b94a43c2-7c72-4a99-bbc4-39948e62a7b3.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"2,500 mg/m3",,rat Triethoxypropylsilane,2550-02-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4c02ef0b-279b-4b72-838d-192dd9819106/documents/504bc74b-05ff-49ed-8bb5-174de350b7e3_b94a43c2-7c72-4a99-bbc4-39948e62a7b3.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"2,500 mg/m3",no adverse effect observed,rat Triethoxypropylsilane,2550-02-9," Oral (OECD TG 401), rat: LD50 > 5110 mg/kg bw. No measured acute inhalation data are available for the registered substance, triethoxypropylsilane, however reliable data are available for the structural analogue substance trimethoxypropylsilane (CAS 1067-25-0) Inhalation (OECD TG 403), rat: 4 h: LC50 > 22200 mg/m³. No measured data are available for the dermal route (data waiving according to Column 2 of REACH Annex VIII, Section 8.5.3). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c02ef0b-279b-4b72-838d-192dd9819106/documents/6d488f7c-fb4b-4610-bded-3ea0c436617b_b94a43c2-7c72-4a99-bbc4-39948e62a7b3.html,,,,,, Triethoxypropylsilane,2550-02-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c02ef0b-279b-4b72-838d-192dd9819106/documents/6d488f7c-fb4b-4610-bded-3ea0c436617b_b94a43c2-7c72-4a99-bbc4-39948e62a7b3.html,,oral,LD50,"> 5,110 mg/kg bw",no adverse effect observed, Triethoxypropylsilane,2550-02-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4c02ef0b-279b-4b72-838d-192dd9819106/documents/6d488f7c-fb4b-4610-bded-3ea0c436617b_b94a43c2-7c72-4a99-bbc4-39948e62a7b3.html,,inhalation,LC50,"> 22,200 mg/m3",no adverse effect observed, Triethoxysilane,998-30-1,"Oral (OECD TG 422, RA from CAS 1185-55-3), rat: NOAEL 60.5 mg/kg bwInhalation - systemic (similar to OECD TG 413, RA from CAS 2487-90-3), rat: NOAEC=3.35 mg/m³Inhalation - local (similar to OECD TG 412, RA from CAS 2487-90-3), rat: NOAEC=1.34 mg/m³Dermal: No data available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/112d1aa5-a5d3-480d-826c-3170b16c484d/documents/acb043c1-5ce6-4d8d-aedf-656541df328a_d3dc6eab-1dbd-411a-b4ec-6597c0880a55.html,,,,,, Triethoxysilane,998-30-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/112d1aa5-a5d3-480d-826c-3170b16c484d/documents/acb043c1-5ce6-4d8d-aedf-656541df328a_d3dc6eab-1dbd-411a-b4ec-6597c0880a55.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,60.5 mg/kg bw/day,,rat Triethoxysilane,998-30-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/112d1aa5-a5d3-480d-826c-3170b16c484d/documents/acb043c1-5ce6-4d8d-aedf-656541df328a_d3dc6eab-1dbd-411a-b4ec-6597c0880a55.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,3.35 mg/m3,,rat Triethoxysilane,998-30-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/112d1aa5-a5d3-480d-826c-3170b16c484d/documents/acb043c1-5ce6-4d8d-aedf-656541df328a_d3dc6eab-1dbd-411a-b4ec-6597c0880a55.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1.34 mg/m3,adverse effect observed,rat Triethoxysilane,998-30-1,"Oral (OECD TG 401), rat: LD50 > 1000 < 2000 mg/kg bw (female) and LD50>2000 mg/kg bw (male)Dermal (OECD TG 402), rabbit: LD50 > 2000 mg/kg bw (limit test)Inhalation (OECD 403) rat, 4 h exposure: LC50 > 500 < 1300 mg/m³ ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/112d1aa5-a5d3-480d-826c-3170b16c484d/documents/b2ce867f-d07d-4d96-9878-bcbe22761160_d3dc6eab-1dbd-411a-b4ec-6597c0880a55.html,,,,,, Triethoxysilane,998-30-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/112d1aa5-a5d3-480d-826c-3170b16c484d/documents/b2ce867f-d07d-4d96-9878-bcbe22761160_d3dc6eab-1dbd-411a-b4ec-6597c0880a55.html,,oral,discriminating dose,"1,000 mg/kg bw",adverse effect observed, Triethoxysilane,998-30-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/112d1aa5-a5d3-480d-826c-3170b16c484d/documents/b2ce867f-d07d-4d96-9878-bcbe22761160_d3dc6eab-1dbd-411a-b4ec-6597c0880a55.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Triethoxysilane,998-30-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/112d1aa5-a5d3-480d-826c-3170b16c484d/documents/b2ce867f-d07d-4d96-9878-bcbe22761160_d3dc6eab-1dbd-411a-b4ec-6597c0880a55.html,,inhalation,discriminating conc.,500 mg/m3,adverse effect observed, Triethyl borate,150-46-9," An initial limit dose of 2,000 mg/kg of body weight was administered to one healthy female rat by oral gavage. Due to the absence of mortality in this animal, four additional females were sequentially dosed at the same dose level. Since all animals survived, no additional animals were tested. Following administration, clinical signs noted for all animals included piloerection, facial staining, hypoactivity, andlor reduced fecal volume. However, all animals recovered by Day 2, and appeared active and healthy for the remainder of the 14-day observation period. No mortality was noted during the study period. Under the conditions of this study, the acute oral LD50 of Trirmethyl Borate is greater than 2000 mg/kg of body weight in female rats and Trimethyl Borate will not be classified in respect of its acute oral toxicity. Based on the supplied read-across justificatuion, this result is also relevant for Triethyl Borate. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbae8b52-c737-4efa-be03-adc4d735f29c/documents/f2ddff98-42e6-4952-ad09-396b6a8c7f14_0ac1bc3c-9095-4020-b090-048a04115717.html,,,,,, Triethyl borate,150-46-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbae8b52-c737-4efa-be03-adc4d735f29c/documents/f2ddff98-42e6-4952-ad09-396b6a8c7f14_0ac1bc3c-9095-4020-b090-048a04115717.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Triethyl phosphonoacetate,867-13-0,"Oral subacute toxicity study in rat (OECD 407): No adverse effects observed in the high dose (1000 mg/kg bw/d) of the 28 days study. Oral subchronic toxicity study in rat (OECD 408): No adverse effects observed in the high dose (1000 mg/kg bw/d) of the 90 days study. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The key study is GLP compliant and of high quality (Klimisch score = 1) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47df710d-e138-473d-a730-3a9ce724a3a3/documents/7d2cfe02-d2de-48da-9160-a1af69c84266_e8338fb8-f6ee-4753-9b31-84eab60c7d7d.html,,,,,, Triethyl phosphonoacetate,867-13-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47df710d-e138-473d-a730-3a9ce724a3a3/documents/7d2cfe02-d2de-48da-9160-a1af69c84266_e8338fb8-f6ee-4753-9b31-84eab60c7d7d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Triethyl phosphonoacetate,867-13-0,"Acute oral toxicity study (similar to OECD 401): LD50 rat > 2000 mg/kg bw, limit testAcute dermal toxicity study (similar to OECD 402): LD50 rabbit > 2000 mg/kg bw, limit testNo study on acute inhalation toxicity is required since the substance is a liquid with very low vapour pressure at ambient temperature. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47df710d-e138-473d-a730-3a9ce724a3a3/documents/a5a54f8d-32af-4cc4-93e6-500f8373cd43_e8338fb8-f6ee-4753-9b31-84eab60c7d7d.html,,,,,, Triethyl phosphonoacetate,867-13-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47df710d-e138-473d-a730-3a9ce724a3a3/documents/a5a54f8d-32af-4cc4-93e6-500f8373cd43_e8338fb8-f6ee-4753-9b31-84eab60c7d7d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Triethyl phosphonoacetate,867-13-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47df710d-e138-473d-a730-3a9ce724a3a3/documents/a5a54f8d-32af-4cc4-93e6-500f8373cd43_e8338fb8-f6ee-4753-9b31-84eab60c7d7d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Triethylammonium bromide,636-70-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c477c8d2-3646-4b03-8b17-33d5abf4bdd2/documents/IUC5-79afdc4e-e10a-4d3d-8bb7-0b2c8a3eaab7_88106923-5d7f-4266-98fc-3c072efe612d.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Triethylborane,97-94-9, Acute oral toxicity study (Rinehart) gave LD50 235 mg/kg Acute inhalation toxicity study (Kimmel) gave LC50 738 ppm No acute dermal toxicity study ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb627eab-fb23-47bc-9958-c21c4ea54fd0/documents/04abafaf-c689-4253-9547-33be9a5b5abc_43637333-7daf-4746-a41e-d5a7033a6464.html,,,,,, Triethylborane,97-94-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bb627eab-fb23-47bc-9958-c21c4ea54fd0/documents/04abafaf-c689-4253-9547-33be9a5b5abc_43637333-7daf-4746-a41e-d5a7033a6464.html,,oral,LD50,235 mg/kg bw,adverse effect observed, Triethylmethylammonium Tetrafluoroborate,69444-47-9, Acute oral toxicity: 300 mg/kg bw < LD50 < 2000 mg/kg bw (OECD 423; GLP; female rats) ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b118bdc8-8a6c-4a40-9ed8-ceb5d698b917/documents/e6cfdeec-a09d-42c3-afa3-abf9de2e3283_5abf5ab2-1b48-4acf-8570-98ebd7639d8a.html,,,,,, "1-(pyrimidin-5-ylmethyl)-3-[3-(trifluoromethyl)phenyl]pyrido[1,2-a]pyrimidin-1-ium-3-ide-2,4-dione",1263133-33-0, Rat studies: 28-Day rat feeding study LOAEL: 20000/10000 ppm (equivalent to 653 mg/kg bw/day) for males and 4000 ppm (equivalent to 317 mg/kg bw/day) for females; OECD 407; Reliability = 1 90-Day rat feeding study LOAEL: 6000 ppm (equivalent to 274 mg/kg bw/day and 316 mg/kg bw/day for males and females respectively); OECD 408; Reliability = 1 90-Day rat feeding study LOAEL: 6000 ppm (equivalent to 257 mg/kg bw/day and 278 mg/kg bw/day for males and females respectively); OECD 408; Reliability = 1 29-Day rat dermal study LOAEL: > 1000 mg/kg; OECD 410; Reliability = 1 Mouse studies: 28-Day mouse feeding study LOAEL: > 7000 ppm (equivalent to 1104 mg/kg bw/day and 1343mg/kg bw/day for males and females respectively); OECD 407; Reliability = 1 90-Day mouse feeding study LOAEL: > 7000 ppm (equivalent to 274 mg/kg bw/day and 316 mg/kg bw/day for males and females respectively); OECD 408; Reliability = 1 Dog studies: 28-Day dog feeding study LOAEL: 3000 ppm (equivalent to 49.52 mg/kg bw/day and 67.07 mg/kg bw/day for males and females respectively); no guideline; Reliability = 1 90-Day dog feeding study LOAEL: 1000 ppm (equivalent to 26.6 mg/kg bw/day and 26.87 mg/kg bw/day for males and females respectively); OECD 409; Reliability = 1 12-Month dog feeding study LOAEL: > 2000 ppm (equivalent to 53.18 mg/kg bw/day and 55.88 mg/kg bw/day for males and females respectively); OECD 452; Reliability = 1 ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc6bc762-1813-4373-9fb5-08c57120daaf/documents/6287bf9e-ecb6-4843-8f74-7eb8d0c55c74_8b721d6a-d486-425b-81fa-4369b0cd7033.html,,,,,, "1-(pyrimidin-5-ylmethyl)-3-[3-(trifluoromethyl)phenyl]pyrido[1,2-a]pyrimidin-1-ium-3-ide-2,4-dione",1263133-33-0," Oral LD50 (rat) > 5000 mg/kg; OECD 425; Reliability = 1 Oral LD50 (rat) > 5000 mg/kg; OECD 425; Reliability = 1 Oral LD50 (rat) > 5000 mg/kg (male); 4930 mg/kg (female); > 4930 mg/kg (combined); National Standard of the People’s Republic of China, GB15670; Reliability = 2 Dermal LD50 (rat) > 5000 mg/kg; OECD 402; Reliability = 1 Inhalation LC50 (rat) > 5.04 mg/L; OECD 403; Reliability = 1 ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc6bc762-1813-4373-9fb5-08c57120daaf/documents/5b132a71-adfb-4ad3-8c2b-3620bcb08783_8b721d6a-d486-425b-81fa-4369b0cd7033.html,,,,,, "1-(pyrimidin-5-ylmethyl)-3-[3-(trifluoromethyl)phenyl]pyrido[1,2-a]pyrimidin-1-ium-3-ide-2,4-dione",1263133-33-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc6bc762-1813-4373-9fb5-08c57120daaf/documents/5b132a71-adfb-4ad3-8c2b-3620bcb08783_8b721d6a-d486-425b-81fa-4369b0cd7033.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "1-(pyrimidin-5-ylmethyl)-3-[3-(trifluoromethyl)phenyl]pyrido[1,2-a]pyrimidin-1-ium-3-ide-2,4-dione",1263133-33-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc6bc762-1813-4373-9fb5-08c57120daaf/documents/5b132a71-adfb-4ad3-8c2b-3620bcb08783_8b721d6a-d486-425b-81fa-4369b0cd7033.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "1-(pyrimidin-5-ylmethyl)-3-[3-(trifluoromethyl)phenyl]pyrido[1,2-a]pyrimidin-1-ium-3-ide-2,4-dione",1263133-33-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc6bc762-1813-4373-9fb5-08c57120daaf/documents/5b132a71-adfb-4ad3-8c2b-3620bcb08783_8b721d6a-d486-425b-81fa-4369b0cd7033.html,,inhalation,LC50,5.04 mg/m3,no adverse effect observed, Trifluoro(isopropylamine)boron,3776-04-3," The LD50of the test item “BF3-isopropylamine-complex” is higher than 50 mg/kg body weight and lower than 300 mg/kg body weight after single oral administration to Wistar rats. Based on Annex 2d Test Procedure with a Starting Dose of 300 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item “BF3-isopropylamine-complex” is according to GHScriteria classified in Category 3 with a LD50cut off value 300 mg/kg body weight, after single oral administration to Wistar rats ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0830db3-a480-47d8-ba4b-dde59934ae2f/documents/9044c7e8-2543-4d8f-9c30-a0b2ecd1a2b4_5cd0f853-01c9-4c5a-8ce9-fd0a711c5176.html,,,,,, Trifluoro(isopropylamine)boron,3776-04-3,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0830db3-a480-47d8-ba4b-dde59934ae2f/documents/9044c7e8-2543-4d8f-9c30-a0b2ecd1a2b4_5cd0f853-01c9-4c5a-8ce9-fd0a711c5176.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Trifluoro(piperidine)boron,592-39-2," The LD50of the test item “BF3-piperidine-complex” is higher than 5 mg/kg body weight and lower than 50 mg/kg body weight after single oral administration to Wistar rats. Based on Annex 2d Test Procedure with a Starting Dose of 50 mg/kg body weight of OECD Guideline 423 it can be concluded that the test item “BF3-piperidine-complex” is according to GHScriteria classified in Category 2 with a LD50cut off value 25 mg/kg body weight, after single oral administration to Wistar rats ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3bcfcfe-5b30-44d3-8201-61292754290e/documents/e4f5d4af-d3a7-4d20-a924-cb9b2d467b01_654f3c56-d4ab-4a8a-9ce0-5a8c37baeb6b.html,,,,,, Trifluoro(piperidine)boron,592-39-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e3bcfcfe-5b30-44d3-8201-61292754290e/documents/e4f5d4af-d3a7-4d20-a924-cb9b2d467b01_654f3c56-d4ab-4a8a-9ce0-5a8c37baeb6b.html,,oral,LD50,25 mg/kg bw,adverse effect observed, Trifluoro(trifluoromethoxy)ethylene,1187-93-5,"- 90-day inhalation study in rats (OECD TG413, EC method B.29), NOAEC systemic effects: 1000 ppm (6790.26 mg/m3) - 28-day repeated dose toxicity study combined with reproductive/developmental screening, by inhalation in rats (OECD TG422), NOEC systemic effects, general toxicity: 300 ppm (2037 mg/m3) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Consistent results were obtained in two good quality repeated dose studies. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca1dd5d3-25da-47af-a5de-3fb743df8e9a/documents/IUC5-254201ba-dc86-4403-9640-1c60e9b20349_39526086-5894-4678-8475-00d1351cff9d.html,,,,,, Trifluoro(trifluoromethoxy)ethylene,1187-93-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ca1dd5d3-25da-47af-a5de-3fb743df8e9a/documents/IUC5-254201ba-dc86-4403-9640-1c60e9b20349_39526086-5894-4678-8475-00d1351cff9d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"6,790.26 mg/m3",,rat Trifluoro(trifluoromethoxy)ethylene,1187-93-5,"The substance is a gas, therefore acute toxicity studies by dermal and oral route are not feasible. The LC50 (4h, rat) value for acute toxicity by inhalation was found to be between 10000 and 15000 ppm. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca1dd5d3-25da-47af-a5de-3fb743df8e9a/documents/IUC5-2ca61684-5454-41c4-9ec1-831a92d7d5a7_39526086-5894-4678-8475-00d1351cff9d.html,,,,,, Trifluoro(trifluoromethoxy)ethylene,1187-93-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ca1dd5d3-25da-47af-a5de-3fb743df8e9a/documents/IUC5-2ca61684-5454-41c4-9ec1-831a92d7d5a7_39526086-5894-4678-8475-00d1351cff9d.html,,inhalation,LC50,"67,901.84 mg/m3",adverse effect observed, Trifluoro(trifluoromethyl)oxirane,428-59-1,"Inhalation: OECD 422; rats. NOEC = 50 ppm (340 mg/m3), based on brain, lung, and spleen weight and histopathological effects at ≥250 ppm. Reliability = 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d1633753-fd22-4b86-9096-8ee75cc9d88d/documents/IUC5-d3192384-2330-456d-85fe-6aec311aeed7_ed4c5be7-173d-4bff-bc54-6b0b52d6243d.html,,,,,, Trifluoro(trifluoromethyl)oxirane,428-59-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d1633753-fd22-4b86-9096-8ee75cc9d88d/documents/IUC5-d3192384-2330-456d-85fe-6aec311aeed7_ed4c5be7-173d-4bff-bc54-6b0b52d6243d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,340 mg/m3,,rat Trifluoro(trifluoromethyl)oxirane,428-59-1,"Oral: In accordance to REACH Annex XI Section 2; information requirement section 8.5.1, guideline testing for acute oral toxicity is technically not feasible because the test substance is a gas.Dermal: In accordance to REACH Annex XI Section 2; information requirement section 8.5.3, guideline testing for acute dermal toxicity is technically not feasible because the test substance is a gas.Inhalation: OECD 403. 4-hr LC50, rat. The LC50 was 2072 ppm (14069 mg/m3). Reliability =2. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1633753-fd22-4b86-9096-8ee75cc9d88d/documents/IUC5-531eb55e-92cc-4f13-a582-557858333a87_ed4c5be7-173d-4bff-bc54-6b0b52d6243d.html,,,,,, Trifluoro(trifluoromethyl)oxirane,428-59-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d1633753-fd22-4b86-9096-8ee75cc9d88d/documents/IUC5-531eb55e-92cc-4f13-a582-557858333a87_ed4c5be7-173d-4bff-bc54-6b0b52d6243d.html,,inhalation,LC50,"14,069 mg/m3",, Trifluoroacetyl chloride,354-32-5,"Trifluoroacetyl chloride (TFAC) is a gas that reacts very rapidly with water and/or air moisture to produce Trifluoroacetic acid (TFA) and HCl. TFAC will therefore not be systemically available and the available information for Trifluoroacetic acid will be considered appropriate to evaluate the effects after repeated exposure. Since TFA is a corrosive liquid, testing was performed by the oral route with the neutralized form of the test substance. A sub-chronic toxicity study by dietary adminstration with the neutral salt sodium trifluoroacetate was identified and is considered appropriate to fulfil this information requirement. A NOAEL of 8.4 and 10.1 mg TFA/kg bw per day in male and female rats, respectively, was established after 90-day oral exposure. The lowest NOAEL of 8.4 mg TFA/kg bw per day was taken forward for risk assessment and DNEL derivation. More information about the read-across justification is included in the Reporting format as attached to the respective IUCLID entry (section 13). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c99e565-004f-40a8-b84d-4f7105913cad/documents/a6c5618e-5316-4bb0-b6a0-9e1cbea4ff4c_dee635d9-23e4-446e-be0f-e46009e34912.html,,,,,, Trifluoroacetyl chloride,354-32-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1c99e565-004f-40a8-b84d-4f7105913cad/documents/a6c5618e-5316-4bb0-b6a0-9e1cbea4ff4c_dee635d9-23e4-446e-be0f-e46009e34912.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,8.4 mg/kg bw/day,,rat Trifluoroacetyl chloride,354-32-5,Acute oral toxicity: WaivingAcute dermal toxicity: WaivingAcute inhalation toxicity: The 4-hour LC50 of Trifluoroacetyl chloride was considered to be between 40 and 90 ppm.  ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c99e565-004f-40a8-b84d-4f7105913cad/documents/3a2059d1-16ad-4e44-b475-ab572d86c650_dee635d9-23e4-446e-be0f-e46009e34912.html,,,,,, Trifluoroacetyl chloride,354-32-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1c99e565-004f-40a8-b84d-4f7105913cad/documents/3a2059d1-16ad-4e44-b475-ab572d86c650_dee635d9-23e4-446e-be0f-e46009e34912.html,,inhalation,LC50,> 40 ,adverse effect observed, Trifluoromethane,75-46-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d8d2bbad-3156-4631-be89-61043c3dcbfe/documents/IUC5-c22c8961-ef17-44b4-9637-1db4caf8cd31_90ce4855-1948-459f-9f33-f6258cc57588.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"28,634 mg/m3",,rat Trifluoromethane,75-46-7,"In accordance to REACH Annex XI Section 2; information requirement section 8.5.1, guideline testing for acute oral toxicity and acute dermal toxicity is technically not feasible because the test substance is a gas.In a K2 acute inhalation study, the substance had very low acute inhalation toxicity with no deaths in rats exposed for four hours to 663000 ppm. Therefore, a 4-hour LC50 of > 663000 ppm in male rats was reported. Anesthetic effects occurred at 186000 ppm but in the absence of oxygen supplementation, anesthetic or CNS effects would be driven by oxygen deprivation, not direct substance effects. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8d2bbad-3156-4631-be89-61043c3dcbfe/documents/IUC5-aadc9c26-58bd-44d6-a0bb-879e0d3240e7_90ce4855-1948-459f-9f33-f6258cc57588.html,,,,,, Trifluoromethane,75-46-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d8d2bbad-3156-4631-be89-61043c3dcbfe/documents/IUC5-aadc9c26-58bd-44d6-a0bb-879e0d3240e7_90ce4855-1948-459f-9f33-f6258cc57588.html,,inhalation,LC50,"1,898,434 mg/m3",no adverse effect observed, Trifluoromethanesulphonic acid,1493-13-6," Based on the results from a repeated oral dose toxicity (28 days, OECD ), no classification is required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f84c138-1db3-4c3d-8811-6be5624a2a62/documents/IUC5-630ea4c8-cd15-46c4-899f-892ba48e8d5e_9b844833-d02c-4353-8c73-2beaffbbe9e5.html,,,,,, Trifluoromethanesulphonic acid,1493-13-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f84c138-1db3-4c3d-8811-6be5624a2a62/documents/IUC5-630ea4c8-cd15-46c4-899f-892ba48e8d5e_9b844833-d02c-4353-8c73-2beaffbbe9e5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Trifluoromethanesulphonic acid,1493-13-6," - Acute oral: LD50/rat (males): 1605.3 mg/kg bw (Key study, Klimisch reliability 2, similar to OECD 401). Therefore, trifluoromethanesulphonic acid is considered as harmful if swallowed (category 4, H302). - Acute dermal: inconclusive results due to severe ulceration at 2000 mg/kg bw (weight of evidence, Klimisch reliability 2, OECD 402 (screening test)). Therefore, a waiving based on the corrosivity of trifluoromethanesulphonic acid (category 1B, H314) was proposed. - Acute inhalation: a waiving based on the corrosivity of trifluoromethanesulphonic acid (category 1B, H314) was proposed ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f84c138-1db3-4c3d-8811-6be5624a2a62/documents/IUC5-c2c1d156-5f45-411f-9ef2-b581581f53fe_9b844833-d02c-4353-8c73-2beaffbbe9e5.html,,,,,, Trifluoromethanesulphonic acid,1493-13-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f84c138-1db3-4c3d-8811-6be5624a2a62/documents/IUC5-c2c1d156-5f45-411f-9ef2-b581581f53fe_9b844833-d02c-4353-8c73-2beaffbbe9e5.html,,oral,LD50,"1,605.3 mg/kg bw",adverse effect observed, Trifluoromethanesulphonic anhydride,358-23-6," Based on the results from a repeated oral dose toxicity (28 days, OECD ) performed on the analog trifluoromethansulfonic acid, no classification is required. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ea23565-ee9d-4251-a8eb-61acc4cc4195/documents/840cef7c-47dc-4d04-983c-bd7a95c89d3d_60c2d943-42ea-425d-9679-1e8a10dd4b0e.html,,,,,, Trifluoromethanesulphonic anhydride,358-23-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8ea23565-ee9d-4251-a8eb-61acc4cc4195/documents/840cef7c-47dc-4d04-983c-bd7a95c89d3d_60c2d943-42ea-425d-9679-1e8a10dd4b0e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Trifluoromethanesulphonic anhydride,358-23-6, The LD50 value of trifluoromethanesulfonic anhydride when administered orally to male SD rats was 1012 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ea23565-ee9d-4251-a8eb-61acc4cc4195/documents/7244b9f5-41e0-47dd-8608-5df93157caf2_60c2d943-42ea-425d-9679-1e8a10dd4b0e.html,,,,,, Trifluoromethanesulphonic anhydride,358-23-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8ea23565-ee9d-4251-a8eb-61acc4cc4195/documents/7244b9f5-41e0-47dd-8608-5df93157caf2_60c2d943-42ea-425d-9679-1e8a10dd4b0e.html,,oral,LD50,"1,012 mg/kg bw",adverse effect observed, Trihexyl phosphate,2528-39-4," Oral (OECD 422), rat: NOAEL systemic ≥ 400 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a27bffaa-81f9-444c-8f08-ca0a65338bae/documents/363e4e07-e075-4c20-a396-c2352668baa5_2668fb6d-b30a-4265-abc4-5cc9611a2959.html,,,,,, Trihexyl phosphate,2528-39-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a27bffaa-81f9-444c-8f08-ca0a65338bae/documents/363e4e07-e075-4c20-a396-c2352668baa5_2668fb6d-b30a-4265-abc4-5cc9611a2959.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,400 mg/kg bw/day,,rat Trihexyl phosphate,2528-39-4, Oral (OECD 423): LD50 > 2000 mg/kg bw (limit test) Dermal (OECD 402): LD50 > 2000 mg/kg bw (limit test) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a27bffaa-81f9-444c-8f08-ca0a65338bae/documents/ebbafd57-c848-450b-9b45-97e09f682109_2668fb6d-b30a-4265-abc4-5cc9611a2959.html,,,,,, Trihexylamine,102-86-3,"Acute toxicity - oral, rat, similar to OECD 401, non-GLP, LD50 = 1150 mg/kg bw, K1 Acute toxicity - dermal, rat, OECD 402, under GLP, discriminating dose = 2000 mg/kg bw, K1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96fe99d5-4ce6-438d-817a-ad0f651ae5ac/documents/17e859ff-3059-4cad-9ced-979e241a2bce_11ac9d6e-b5fc-4721-a108-0b2517fe920d.html,,,,,, Trihexylamine,102-86-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96fe99d5-4ce6-438d-817a-ad0f651ae5ac/documents/17e859ff-3059-4cad-9ced-979e241a2bce_11ac9d6e-b5fc-4721-a108-0b2517fe920d.html,,oral,LD50,"ca.1,150 mg/kg bw",adverse effect observed, Trihexylamine,102-86-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96fe99d5-4ce6-438d-817a-ad0f651ae5ac/documents/17e859ff-3059-4cad-9ced-979e241a2bce_11ac9d6e-b5fc-4721-a108-0b2517fe920d.html,,dermal,discriminating dose,"2,000 mg/kg bw",adverse effect observed, Trihydrogen trifluoro[phosphato(3-)-O]borate(3-),13669-76-6,All the studies conducted with BF3 (gas) or BF3 dihydrate cause signs of respiratory distress. This effect was already seen in the acute toxicity tests. Furthermore necrosis of the proximal tubuli were observed in some animals. This effect correlates with the increasing amount of fluoride in urine. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d85082d9-498d-401c-84e2-c2c7872a1e28/documents/IUC5-eb3a28a0-4baa-49ea-b0d8-1574dae40f4b_1dc0fa94-80ee-4a00-9915-236d9eb63a0f.html,,,,,, Trihydrogen trifluoro[phosphato(3-)-O]borate(3-),13669-76-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d85082d9-498d-401c-84e2-c2c7872a1e28/documents/IUC5-eb3a28a0-4baa-49ea-b0d8-1574dae40f4b_1dc0fa94-80ee-4a00-9915-236d9eb63a0f.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,6 mg/m3,,rat Trihydrogen trifluoro[phosphato(3-)-O]borate(3-),13669-76-6,"The LC50 (4 h) is 1210 mg/m3 in rats with boron trifluoride dihydrate (Rusch et al., 1986). Animals mainly exhibited typical clinical signs of respiratory distress. All respiratory effects were reversible. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d85082d9-498d-401c-84e2-c2c7872a1e28/documents/IUC5-f0c2e89e-ea66-4541-bb8e-0c5b009599ef_1dc0fa94-80ee-4a00-9915-236d9eb63a0f.html,,,,,, Trihydrogen trifluoro[phosphato(3-)-O]borate(3-),13669-76-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d85082d9-498d-401c-84e2-c2c7872a1e28/documents/IUC5-f0c2e89e-ea66-4541-bb8e-0c5b009599ef_1dc0fa94-80ee-4a00-9915-236d9eb63a0f.html,,oral,LD50,"2,600 mg/kg bw",adverse effect observed, Trihydrogen trifluoro[phosphato(3-)-O]borate(3-),13669-76-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d85082d9-498d-401c-84e2-c2c7872a1e28/documents/IUC5-f0c2e89e-ea66-4541-bb8e-0c5b009599ef_1dc0fa94-80ee-4a00-9915-236d9eb63a0f.html,,inhalation,LC50,"1,210 mg/m3",adverse effect observed, "Trihydrogen tris[P,P-dioctyl diphosphato(2-)-O'',O''''](propan-2-olato)titanate(3-), branched and linear",68585-78-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/02ebee49-bacb-4242-86cf-1b3a6fa0889c/documents/bdfef6a9-bdc4-4063-bca9-298d9689a901_96aefb9b-c1e3-4756-9d11-f51ac4910ba3.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,ca.400 mg/kg bw/day,,rat "Trihydrogen tris[P,P-dioctyl diphosphato(2-)-O'',O''''](propan-2-olato)titanate(3-), branched and linear",68585-78-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/02ebee49-bacb-4242-86cf-1b3a6fa0889c/documents/5dc0c692-4183-48cb-ab90-711f06ae1b65_96aefb9b-c1e3-4756-9d11-f51ac4910ba3.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Triiron bis(orthophosphate),14940-41-1, Triiron bis(orthophosphate) does not show adverse effects in oral repeated dose toxicity studies in animals. Extensive information on an absence of severe adverse effects in humans is available. Solely adverse gastro-intestinal effects are observed after acute ingestion of extremely high doses of (soluble) non-haem iron substances. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ee15f20-c955-4b8b-93f4-7c934999b498/documents/37338b51-93b4-411a-abaa-a4fb1ebeb903_91ed03c8-e9e8-41b0-aa19-2ad68d93df86.html,,,,,, Triiron bis(orthophosphate),14940-41-1, Acute oral toxicity: LD50 (female rats) > 2000 mg/kg bw (OECD 423; GLP) Acute inhalation toxicity: LC50 (male and female rats) > 2.76 mg/L (actual concentration; maximum attainable concentration) (OECD 436; GLP) Acute dermal toxicity: data waiving ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ee15f20-c955-4b8b-93f4-7c934999b498/documents/c8b0dc1c-c6a6-4b5b-80df-5fa0bfc8f2e3_91ed03c8-e9e8-41b0-aa19-2ad68d93df86.html,,,,,, Triisobutyl phosphate,126-71-6,"In a subchronic oral study (similar OECD 408, GLP, reliability 2) in rats a NOEL/NOAEL of 68.4 mg/kg bw in males and 84.3 mg/kg bw in females was observed. Effects observed at the next higher dose level were decreased foodconsumption, minor alterations of hematology parameters and clinical chemistry. However, the BAuA evaluated this study and concluded that the observed effects at the highest treatment level, 5000 mg/kg diet are not toxicological relevant. The BAuA therefore, decided that the dosis of 5000 mg/kg diet can be assumed to be a marginal LOEL which will only be slightly above the actual NOAEL. According to the BauA it can thus be assumed that for the estimation of an OEL, a NAEL of 2500 mg/kg diet, which corresponds to 170 mg/kg bw for male and 210 mg/kg bw for female rats, can be used. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e20291c-6d93-4cf7-a5d7-0199e0ab3161/documents/IUC5-e6572ffa-f979-4077-87db-a421e7d68c5e_2a37cf0a-3844-4c4e-9320-f8d828aabe8a.html,,,,,, Triisobutyl phosphate,126-71-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e20291c-6d93-4cf7-a5d7-0199e0ab3161/documents/IUC5-e6572ffa-f979-4077-87db-a421e7d68c5e_2a37cf0a-3844-4c4e-9320-f8d828aabe8a.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,68.4 mg/kg bw/day,,rat Triisobutyl phosphate,126-71-6,"oral: according to EPA guideline, GLP, reliability 1: LD50,rat > 5000 mg/kg bw inhalation: OECD 403, GLP, reliability 1: LC50, rat, aerosol > 5.14 mg/mL dermal: according to EPA guideline, GLP, reliability 1: LD50,rabbit > 5000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e20291c-6d93-4cf7-a5d7-0199e0ab3161/documents/IUC5-f1012382-01a1-49c0-8dc3-9644fd4c4030_2a37cf0a-3844-4c4e-9320-f8d828aabe8a.html,,,,,, Triisobutyl phosphate,126-71-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e20291c-6d93-4cf7-a5d7-0199e0ab3161/documents/IUC5-f1012382-01a1-49c0-8dc3-9644fd4c4030_2a37cf0a-3844-4c4e-9320-f8d828aabe8a.html,,oral,LD50,"> 5,000 mg/kg bw",adverse effect observed, Triisobutyl phosphate,126-71-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e20291c-6d93-4cf7-a5d7-0199e0ab3161/documents/IUC5-f1012382-01a1-49c0-8dc3-9644fd4c4030_2a37cf0a-3844-4c4e-9320-f8d828aabe8a.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Triisobutyl phosphate,126-71-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e20291c-6d93-4cf7-a5d7-0199e0ab3161/documents/IUC5-f1012382-01a1-49c0-8dc3-9644fd4c4030_2a37cf0a-3844-4c4e-9320-f8d828aabe8a.html,,inhalation,discriminating conc.,"5,140 mg/m3",no adverse effect observed, "Triisononanoic acid, triester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)propane-1,3-diol] tris(2-ethylhexanoate)",68443-84-5,"A 28 -day study (Jones, 2000) with the structural analogue Dipentaerythritol ester of nC5/iC9 acids is available, where no adverse effects were found revealing a NOAEL of 1000 mg/kg bw (highest dose tested). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c223d553-4365-4fc4-b2de-7dae8111c7ca/documents/IUC5-c49554fe-81e1-4e4f-8114-f68aaf01aa31_341d47e1-9907-4cd0-b51b-3a0e5be6c67c.html,,,,,, "Triisononanoic acid, triester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)propane-1,3-diol] tris(2-ethylhexanoate)",68443-84-5,"Acute oral toxicity:according to OECD 420, in compliance with GLP, RL2 (Baily, 1999): LD50>2000 mg/kg bwAcute inhalation toxicity:according to OECD 403, no GLP, RL2 (Parr-Dobrzanski, 1994): LC50>5.1 mg/L air.Acute dermal toxicity:according to OECD 402, in compliance with GLP, RL1 (Allan, 1999): LD50>2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c223d553-4365-4fc4-b2de-7dae8111c7ca/documents/IUC5-e0b540ce-c646-4322-96a2-f15ec213331b_341d47e1-9907-4cd0-b51b-3a0e5be6c67c.html,,,,,, "Triisononyl benzene-1,2,4-tricarboxylate",53894-23-8,28 -day sub-acute toxicity: NOAEL 1000 mg/kg/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/289b6ad4-e57e-4cda-be9a-5eccc8457246/documents/5942d5c6-bbaf-4b33-b362-878e8a1e625f_b3d83ffe-c5b3-44de-81c6-d720ce96f607.html,,,,,, "Triisononyl benzene-1,2,4-tricarboxylate",53894-23-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/289b6ad4-e57e-4cda-be9a-5eccc8457246/documents/5942d5c6-bbaf-4b33-b362-878e8a1e625f_b3d83ffe-c5b3-44de-81c6-d720ce96f607.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Triisononyl benzene-1,2,4-tricarboxylate",53894-23-8, Acute toxicity: Oral: LD50 > 2000 mg/kg bw Inhalation: LC50 > 5.0 mg/L Dermal: LD50 > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/289b6ad4-e57e-4cda-be9a-5eccc8457246/documents/1251750b-8574-46d2-b36e-c76da0dd329a_b3d83ffe-c5b3-44de-81c6-d720ce96f607.html,,,,,, "Triisononyl benzene-1,2,4-tricarboxylate",53894-23-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/289b6ad4-e57e-4cda-be9a-5eccc8457246/documents/1251750b-8574-46d2-b36e-c76da0dd329a_b3d83ffe-c5b3-44de-81c6-d720ce96f607.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Triisononyl benzene-1,2,4-tricarboxylate",53894-23-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/289b6ad4-e57e-4cda-be9a-5eccc8457246/documents/1251750b-8574-46d2-b36e-c76da0dd329a_b3d83ffe-c5b3-44de-81c6-d720ce96f607.html,,dermal,LD50,"3,160 mg/kg bw",no adverse effect observed, "Triisononyl benzene-1,2,4-tricarboxylate",53894-23-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/289b6ad4-e57e-4cda-be9a-5eccc8457246/documents/1251750b-8574-46d2-b36e-c76da0dd329a_b3d83ffe-c5b3-44de-81c6-d720ce96f607.html,,inhalation,discriminating conc.,"56,000 mg/m3",no adverse effect observed, "Triisooctyl 2,2',2''-[(octylstannylidyne)tris(thio)]triacetate",26401-86-5," Repeated Dose Toxicity: oral Available information on the registered substance is considered together as part of a weight of evidence approach. 28-day rat, Til et al 1973 Under the conditions of the study the 28-day repeated oral dose NOAEL, to the Wistar strain of rat, was determined to be 1500 ppm, the highest dose level tested. 90-day rat, Til et al 1973 Under the conditions of this study the no-observed effect level of the test material was determined to be lower than 300 ppm when dosed in the diet of rats for three months. 90-day rat, Til et al 1974 Under the conditions of this study the no observed effect level of the test material was 300 ppm when administered in the diet of rats for three months (equivalent to 15 mg/kg bw/ day). 90-day dog, Til et al 1973 The no-effect level of the test compound was 300 ppm in the diet of dogs for 13 weeks. 90-day rat, Drake (1974) Under the conditions of this study the test material caused a very slight dose related increase in adrenal weights (both absolute and relative) in male animals after treatment in the diet for 90 days at 100 and 500 ppm. This effect was entirely reversible. Read-across to structurally similar substance: Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) (CAS No 27107 -89 -7) A GLP guideline  study  was well conducted in accordance with test guideline EU B.26/OECD 408, and provided a clear NOAEL. The results of this study indicating that MOTE is relatively non toxic compared to related organotin compounds, provide sufficient basis for risk assessment. NOAEL: 1250 mg/kg diet (82 and 91 mg/kg body weight/day for males and females, respectively); Wistar rat; 90 days; OECD 408 and EU Method B.26. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/708a21d6-9f13-4ab4-8022-0395b330a1ad/documents/978083b2-222a-4aab-9a9e-4d4ae2033ef1_48a1c9e2-37d7-43fd-82d7-a34853900828.html,,,,,, "Triisooctyl 2,2',2''-[(octylstannylidyne)tris(thio)]triacetate",26401-86-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/708a21d6-9f13-4ab4-8022-0395b330a1ad/documents/978083b2-222a-4aab-9a9e-4d4ae2033ef1_48a1c9e2-37d7-43fd-82d7-a34853900828.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,82 mg/kg bw/day,,rat "Triisooctyl 2,2',2''-[(octylstannylidyne)tris(thio)]triacetate",26401-86-5," The information on acute oral toxicity was assessed in a weight of evidence approach. It was concluded the registered substance does not require classification with respect to acute toxicity via the oral and dermal routes of exposure. - Acute Oral Toxicity Auletta (1984) Under the conditions of this study the acute oral LD50 value to CDR Sprague Dawley rats was determined to be 1700 mg/kg. Bathe (1973) Under the conditions of the study the LD50 of the test material was determined to be 5000 mg/kg. Gunzel & Richter (1969) Under the conditions of this study, the oral LD50 value in male Wistar rats was established to exceed 4000 mg/kg body weight. Klimmer (1969) Under the conditions of the study the acute oral LD50 to male Wistar rats was 2.85 mL/kg (3078 mg/kg). Prinsen (2012) Read across to Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) (CAS No 27107-89-7) Under the conditions of this study, the oral LD50 value in female Sprague-Dawley rats was established to exceed 2000 mg/kg body weight. - Acute Dermal Toxicity Prinsen (2010) Read across to Octyltin tris(2-ethylhexylmercaptoacetate) (MOTE) (CAS No 27107-89-7) Based on the result obtained from the test (LD0 >2000 mg/kg bw) the test material does not meet the criteria for classification as set out in 67/548/EEC. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/708a21d6-9f13-4ab4-8022-0395b330a1ad/documents/2e74915a-f1a2-4b0e-8f4e-01a57afa0612_48a1c9e2-37d7-43fd-82d7-a34853900828.html,,,,,, "Triisooctyl 2,2',2''-[(octylstannylidyne)tris(thio)]triacetate",26401-86-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/708a21d6-9f13-4ab4-8022-0395b330a1ad/documents/2e74915a-f1a2-4b0e-8f4e-01a57afa0612_48a1c9e2-37d7-43fd-82d7-a34853900828.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Triisooctylamine,25549-16-0," Based on a weight of evidence evaluation of an OECD 422 compliant study and an 28 days repeated dose toxicity study, the NOAEL for oral repeated dose toxicity in rats was determined to be 10 mg/kg bw/d based on increased white blood cell count and thyroid hyperplasia findings in female and male animals, respectively. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66af88d3-88de-4021-9fec-0aeb77d1ac04/documents/a5b02d50-e5dc-45f7-afa6-cb3c6f021c1f_8d2bdfe8-7d1d-4f95-b848-232cb0109213.html,,,,,, Triisooctylamine,25549-16-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66af88d3-88de-4021-9fec-0aeb77d1ac04/documents/a5b02d50-e5dc-45f7-afa6-cb3c6f021c1f_8d2bdfe8-7d1d-4f95-b848-232cb0109213.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Triisooctylamine,25549-16-0,"LD50(oral) >300 and < 2000 mg/kg bw (Bioassay, 2015)LD50(dermal) > 2000 mg/kg bw (Bioassay, 2014) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66af88d3-88de-4021-9fec-0aeb77d1ac04/documents/IUC5-49be02ff-1c4c-4377-9bbe-b742ecd38acf_8d2bdfe8-7d1d-4f95-b848-232cb0109213.html,,,,,, Triisopropyl borate,5419-55-6,Key study: OECD 401: A LD50 value of 8126 mg/kg was determiend in male rats.  ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd2ce049-0a06-4594-b4bb-2f4091cfc62d/documents/8ee72473-1be7-4b7b-a812-a0d1b560b9ef_c436b712-b917-4bce-adc2-ceafd22386a8.html,,,,,, Triisopropyl borate,5419-55-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd2ce049-0a06-4594-b4bb-2f4091cfc62d/documents/8ee72473-1be7-4b7b-a812-a0d1b560b9ef_c436b712-b917-4bce-adc2-ceafd22386a8.html,,oral,LD50,"8,126 mg/kg bw",adverse effect observed, Triisotridecyl phosphite,77745-66-5, • 90 -Day repeated dose oral toxicity (OECD 408) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edbb0c67-41b8-4c01-b3f0-79ff4392f80a/documents/7537eab3-6092-4725-b543-6754c4c3edfc_d23b571a-3ff8-407b-b033-d3b1a4f64e07.html,,,,,, Triisotridecyl phosphite,77745-66-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/edbb0c67-41b8-4c01-b3f0-79ff4392f80a/documents/7537eab3-6092-4725-b543-6754c4c3edfc_d23b571a-3ff8-407b-b033-d3b1a4f64e07.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Triisotridecyl phosphite,77745-66-5,"There were no signs of acute toxicity via the oral, dermal or inhalation routes. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edbb0c67-41b8-4c01-b3f0-79ff4392f80a/documents/1d21f4ee-6b2b-423d-bf69-7d261be5c9f8_d23b571a-3ff8-407b-b033-d3b1a4f64e07.html,,,,,, Triisotridecyl phosphite,77745-66-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edbb0c67-41b8-4c01-b3f0-79ff4392f80a/documents/1d21f4ee-6b2b-423d-bf69-7d261be5c9f8_d23b571a-3ff8-407b-b033-d3b1a4f64e07.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Triisotridecyl phosphite,77745-66-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edbb0c67-41b8-4c01-b3f0-79ff4392f80a/documents/1d21f4ee-6b2b-423d-bf69-7d261be5c9f8_d23b571a-3ff8-407b-b033-d3b1a4f64e07.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Triisotridecyl phosphite,77745-66-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/edbb0c67-41b8-4c01-b3f0-79ff4392f80a/documents/1d21f4ee-6b2b-423d-bf69-7d261be5c9f8_d23b571a-3ff8-407b-b033-d3b1a4f64e07.html,,inhalation,LC50,"12,600 mg/m3",no adverse effect observed, Trilead bis(carbonate) dihydroxide,1319-46-6,"Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function including the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab8488ae-92d0-4f2e-b2b1-5387ce639a91/documents/IUC5-23a3723b-3f69-4678-a994-4707683fe2da_cbdd502d-31a0-4ec9-a492-80327753917c.html,,,,,, Trilead bis(carbonate) dihydroxide,1319-46-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab8488ae-92d0-4f2e-b2b1-5387ce639a91/documents/IUC5-23a3723b-3f69-4678-a994-4707683fe2da_cbdd502d-31a0-4ec9-a492-80327753917c.html,Chronic toxicity – systemic effects,oral,LOAEL,0.005 mg/kg bw/day,,rat Trilead bis(carbonate) dihydroxide,1319-46-6,Inorganic lead compounds do not exhit toxicity in acute toxicity tests with experimental animals. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab8488ae-92d0-4f2e-b2b1-5387ce639a91/documents/IUC5-c2945367-8b07-4814-a96e-3711da02b1d0_cbdd502d-31a0-4ec9-a492-80327753917c.html,,,,,, Trilead bis(carbonate) dihydroxide,1319-46-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab8488ae-92d0-4f2e-b2b1-5387ce639a91/documents/IUC5-c2945367-8b07-4814-a96e-3711da02b1d0_cbdd502d-31a0-4ec9-a492-80327753917c.html,,oral,LD50,"5,000 mg/kg bw",, Trilead bis(carbonate) dihydroxide,1319-46-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab8488ae-92d0-4f2e-b2b1-5387ce639a91/documents/IUC5-c2945367-8b07-4814-a96e-3711da02b1d0_cbdd502d-31a0-4ec9-a492-80327753917c.html,,dermal,LD50,"2,000 mg/kg bw",, Trilead bis(carbonate) dihydroxide,1319-46-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab8488ae-92d0-4f2e-b2b1-5387ce639a91/documents/IUC5-c2945367-8b07-4814-a96e-3711da02b1d0_cbdd502d-31a0-4ec9-a492-80327753917c.html,,inhalation,LC50,"5,050 mg/m3",, Trilead dioxide phosphonate,12141-20-7," Lead has been documented in observational human studies to produce toxicity in multiple organ systems and body function includine the haemotopoetic sytem, kidney function, reproductive function and the central nervous system. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/d54e4ecb-6520-4341-8f99-4ac512466512/documents/55240df1-e7fa-4fe8-8269-766f9e1416fc_ce0f7f57-a89c-4f3e-a065-097e958b37c6.html,,,,,, Trilead dioxide phosphonate,12141-20-7, Inorganic lead compounds do not exhibit toxicity in acute toxicity tests with experimental animals. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d54e4ecb-6520-4341-8f99-4ac512466512/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_ce0f7f57-a89c-4f3e-a065-097e958b37c6.html,,,,,, Trilead dioxide phosphonate,12141-20-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d54e4ecb-6520-4341-8f99-4ac512466512/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_ce0f7f57-a89c-4f3e-a065-097e958b37c6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Trilead dioxide phosphonate,12141-20-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d54e4ecb-6520-4341-8f99-4ac512466512/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_ce0f7f57-a89c-4f3e-a065-097e958b37c6.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Trilead dioxide phosphonate,12141-20-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d54e4ecb-6520-4341-8f99-4ac512466512/documents/63077110-7b4b-4aed-9638-6a65e28ac3a5_ce0f7f57-a89c-4f3e-a065-097e958b37c6.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, Trilithium hexafluoroaluminate,13821-20-0," The inhalation toxicity of Lithium Cryolite was studied in a sub-acute (28-day) inhalation toxicity study in Wistar rats performed in accordance with the OECD Testing Guideline No 412 and the GLP. Four groups of 5 male and 5 female rats were exposed nose-only to target concentrations of 0 (control), 1, 3 or 10 mg/m3 Lithium Cryolite for 6 hours/day, 5 days/week over a 28-day period, with a total of 20 exposure days. The animals were sacrificed on the day after the last exposure. To investigate the toxicity, data on clinical observations, body weight, food consumption, haematology and clinical chemistry were collected. At necropsy, the animals were examined for gross macroscopic abnormalities, organs were weighed and a selection of organs and tissues (including the complete respiratory tract with nasal passages) was examined microscopically. The concentration levels were selected on the basis of a 7-day range finding study (5 exposure days in total) in which groups of 3 male and 3 female rats were exposed to target concentrations of 0, 2, 10 or 50 mg/m3. In this range finding study, exposure at 50 mg/m3 induced epithelial degeneration in the nose, increased weight of the lungs, alveolitis, accumulation of alveolar macrophages and enlarged tracheobronchial lymph nodes. At 10 mg/m3, increased lung weights and epithelial degeneration in the nose were still observed, while no clear exposure-related effects were observed at 2 mg/m3. In the main study, the mean actual concentrations (± standard deviation) of Lithium Cryolite in the various test atmospheres – based on gravimetric analysis – were 1.01 (+/- 0.07), 3.34 (+/- 0.24) or 10.22 (+/- 0.38) mg/m3 for the low, mid and high concentration levels, respectively. The average particle size (Mass Median Aerodynamic Diameter; MMAD) was 1.06 µm (with a geometric standard deviation of 1.93), 1.39 µm (gsd of 1.97) and 1.47 µm (gsd of 1.91) for the low, mid and high concentration test atmospheres, respectively. There were no treatment-related clinical abnormalities and no changes in growth or food consumption in the main study. Haematology and clinical chemistry, conducted in all rats at necropsy, did not reveal any treatment-related changes. A decrease in plasma cholesterol concentration in females of the high concentration group was considered of doubtful, if any toxicological significance. The weight of the lungs showed a concentration-dependent increase, which reached the level of statistical significance at the mid and high concentration, and for relative lung weight in male animals also at the low concentration. The relative weight of the spleen was decreased in females of the mid and high concentration group. Other significant changes in organ weights were not found. Macroscopic examination at the end of the exposure period revealed no treatment-related gross lesions. Microscopic examination of the lungs revealed a concentration-dependent increase in the number of enlarged/activated alveolar macrophages in all exposed groups. In addition, perivascular mononuclear inflammation was observed in the lungs of one female of the low concentration, in three males and three females of the mid concentration, and in four males and one female of the high concentration group. In the treacheobronchial lymph nodes, accumulation of macrophage aggregates was noted at the high concentration level. Microscopic examination of the nose revealed ulceration and metaplasia of the olfactory epithelium in posterior part of the nasal cavity of animals of the mid and high concentration group. Exposure to Lithium Cryolite at concentrations of 3.34 mg/m3 or higher resulted in adverse changes in the nose, lungs and tracheobronchial lymph nodes. Changes observed upon exposure to the low concentration of 1.01 mg/m3 Lithium Cryolite –i.e. accumulation of alveolar macrophages and an associated increased relative lung weight in males – were considered to represent a non-adverse adaptive response to the exposure. Therefore, the No-Observed-Adverse-Effect-Level (NOAEL) of Lithium Cryolite in rats exposed for 6 hours/day, 5 days/week for a period of 28 days was considered to be 1.01 mg/m3. No data on repeated dose toxicity via oral and dermal routes is available. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64c7de32-53b6-4530-b336-abc98956584e/documents/IUC5-380ed866-686e-4f3b-80d0-90bc464527a1_9ab4a353-48bf-4093-a580-67096cd2a266.html,,,,,, Trilithium hexafluoroaluminate,13821-20-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64c7de32-53b6-4530-b336-abc98956584e/documents/IUC5-380ed866-686e-4f3b-80d0-90bc464527a1_9ab4a353-48bf-4093-a580-67096cd2a266.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1.01 mg/m3,adverse effect observed,rat Trilithium hexafluoroaluminate,13821-20-0," The acute oral toxicity of Lithium cryolite in the rat was investigated according to the Acute Toxic Class Method of the OECD Testing Guideline 423 and under GLP. Initially, Lithium cryolite was administered by oral gavage to three female Wistar rats at 2000 mg/kg body weight. In a stepwise procedure two additional groups of three females were dosed at 300 mg/kg body weight. All animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed on the day of death or after terminal sacrifice (Day 15). At 2000 mg/kg all three animals dosed were found dead on Days 2, 4 and 6 respectively. No further mortality occurred at 300 mg/kg. At 2000 mg/kg hunched posture, piloerection, ptosis and/or hypothermia were noted among the majority of animals between Days 1 and 6. At 300 mg/kg hunched posture and/or piloerection were noted among the animals on Days 1 and/or 2. The body weight gain shown by the animals over the study period was considered to be normal. Macroscopic post mortem examination of one animal found dead revealed abnormalities of the stomach (isolated, dark red focus/foci in the glandular mucosa) and caecum (isolated dark red focus/foci). Macroscopic post mortem examination of the other animals that died during the study and of the surviving animals at termination did not reveal any abnormalities. The oral LD50 value of Lithium cryolite in Wistar rats was established to be within the range of 300-2000 mg/kg body weight.   The acute inhalation toxicity of Lithium cryolite in the rat was investigated according to the OECD Testing Guideline 403 and under GLP. Lithium cryolite was administered as an aerosol by inhalation for 4 hours to one group of five male and five female Wistar rats at 1 mg/L. Based on the results, one group of five females was dosed at 0.5 mg/L. Animals were subjected to daily observations and determination of body weights on Days 1, 2, 4, 8 and 15 and at death. Macroscopic examination was performed on the day of death or after terminal sacrifice (Day 15). For the exposure to 1 mg/L, the time-weighted mean actual concentration was 1.1 ± 0.05 mg/L. For the exposure to 0.5 mg/L, the time-weighted mean actual concentration was 0.52 ± 0.01 mg/L. The concentration measurements distributed over time showed that the substance was sufficiently stable. The Mass Median Aerodynamic Diameter (MMAD) and geometric standard deviation (gsd) were determined twice. At 1 mg/L, the MMAD was 2.9 µm (gsd 2.0) and 2.6 µm (gsd 2.0). At 0.5 mg/L, the MMAD was 3.6 µm (gsd 1.9) and 3.2 µm (gsd 1.8). At 1 mg/L, two females were found dead on Days 3 and 4. Two males and three females were sacrificed for ethical reasons on days 4 and 5. At 0.5 mg/L, one female was sacrificed on day 5. No further mortality occurred. At 1 mg/L, slow breathing was noted among the animals during exposure. After exposure, lethargy, flat posture, hunched posture, slow breathing, laboured respiration, shallow respiration, piloerection, chromodacryorrhoea, ptosis and or hypothermia were noted among the animals. The surviving animals recovered from the symptoms between Days 7 and 9. At 0.5 mg/L, no clinical signs were seen during exposure. After exposure, abnormal posture, hunched posture, piloerection, dehydration, lean appearance and/or ptosis were seen among the animals. The surviving animals had recovered from the symptoms by Day 11. Body weight loss was noted among all surviving animals during the first week post-exposure. All animals regained weight during the second week. Macroscopic post mortem examination revealed abnormalities of the thymes (reduced in size) of one female (0.5 mg/L) sacrificed for ethical reasons during the study. No other findings were noted in any of the animals. Based on the above observations, the inhalatory LC50, 4h value of LITHIUM CRYOLITE in Wistar rats was established to be within the range of 0.5 – 1 mg/L.   The acute dermal toxicity of Lithium cryolite in the rat was investigated according to the OECD Testing Guideline 402 and under GLP. Lithium cryolite was administered to five Wistar rats of each sex by a single dermal application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). No mortality occurred. Chromodacryorrhoea was noted for all animals on Days 1 and 2. General erythema, erythema maculate, scales and/or scabs were noted among the female animals between Days 3 and 15. The mean body weight gain during the observation period was within the range expected for rats used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals. The dermal LD50 value of Lithium cryolite in Wistar rats was established to exceed 2000 mg/kg body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64c7de32-53b6-4530-b336-abc98956584e/documents/IUC5-ad2b075b-3c9c-419f-8f52-72713ee33740_9ab4a353-48bf-4093-a580-67096cd2a266.html,,,,,, Trilithium hexafluoroaluminate,13821-20-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64c7de32-53b6-4530-b336-abc98956584e/documents/IUC5-ad2b075b-3c9c-419f-8f52-72713ee33740_9ab4a353-48bf-4093-a580-67096cd2a266.html,,oral,LD50,500 mg/kg bw,adverse effect observed, Trilithium hexafluoroaluminate,13821-20-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64c7de32-53b6-4530-b336-abc98956584e/documents/IUC5-ad2b075b-3c9c-419f-8f52-72713ee33740_9ab4a353-48bf-4093-a580-67096cd2a266.html,,inhalation,LC50,500 mg/m3,adverse effect observed, Trilithium nitride,26134-62-3, Lithium nitride is regarded as corrosive to the skin. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f838ed9b-2a98-40b8-9c62-ca32401912d8/documents/30bb8c0b-f63a-4d75-a021-b33d25bda40a_3d96725a-f352-431b-a884-62b6173ac9e9.html,,,,,, Trilithium orthophosphate,10377-52-3, Based on human data a NOAEL for long-term oral toxicity of 6.67 mg lithium phosphate/kg bw/day was calculated. Performance of repeated dermal and inhalation toxicity studies were waived.   ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fd9eca6-b91d-4cb9-b8ed-0647f6ee82e8/documents/6f76a1a7-7ce8-416e-bbc8-780389074d31_78ce3211-7e35-4784-bfb2-5d67d150bdbb.html,,,,,, Trilithium orthophosphate,10377-52-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9fd9eca6-b91d-4cb9-b8ed-0647f6ee82e8/documents/6f76a1a7-7ce8-416e-bbc8-780389074d31_78ce3211-7e35-4784-bfb2-5d67d150bdbb.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,6.67 mg/kg bw/day,, Trilithium orthophosphate,10377-52-3," Acute oral toxicity: LD50 of 613 mg Li2SO4/kg bw/day Acute dermal toxicity: LD50 >3000 mg LiNO3/kg bw/day Acute inhalation toxicity: Testing for acute toxicity via the inhalation route was not applicable as data on acute oral and acute dermal toxicity were available. According to REACH Regulation No. 1907/2006, Annex VIII, 8.5 data for a maximum of two routes of exposure need to be provided. Furthermore, considering the high melting point (1205 °C) and the very low vapor pressure (4.88E-022 Pa) of lithium phosphate, exposure by inhalation is unlikely. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fd9eca6-b91d-4cb9-b8ed-0647f6ee82e8/documents/fbf06197-17ee-4b94-8c32-f446a22d4be3_78ce3211-7e35-4784-bfb2-5d67d150bdbb.html,,,,,, Trilithium orthophosphate,10377-52-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fd9eca6-b91d-4cb9-b8ed-0647f6ee82e8/documents/fbf06197-17ee-4b94-8c32-f446a22d4be3_78ce3211-7e35-4784-bfb2-5d67d150bdbb.html,,oral,LD50,613 mg/kg bw,adverse effect observed, Trilithium orthophosphate,10377-52-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fd9eca6-b91d-4cb9-b8ed-0647f6ee82e8/documents/fbf06197-17ee-4b94-8c32-f446a22d4be3_78ce3211-7e35-4784-bfb2-5d67d150bdbb.html,,dermal,discriminating dose,"3,000 mg/kg bw",no adverse effect observed, Trimagnesium dicitrate,3344-18-1,"Read across from a fairly limited reliable report of a non-standard oral feeding study using citric acid in the rat, conducted without GLP compliance, identified 5-day NOAEL values in the rat of 4000 mg/kg bw/day (which corresponds to 4680 mg tri magnesium dicitrate /kg (bw)/d*). (Hoffman, 1976; rel 2) In addition read across from a fairly limited reliable report of a non-standard 10 day feeding study using citric acid conducted without GLP compliance in mice and rats, identified 10-day NOAEL values in the mouse of 1000 and 4000 g/kg bw/day, (which corresponds to 1170 and 4680 mg tri magnesium dicitrate /kg (bw)/d*)respectively.* based on a conversion factor of 1.17 derived by: (Mass of one mole of salt)/(mass of citric acid produced when trimagnesium dicitrate dissociates) = 451.1 / (2 * 192.9) = 1.29. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9b2fd36a-cf2a-4512-b53d-0835f3d65b6a/documents/IUC5-b42eb95f-60e1-476b-9851-73fb161c16fa_655e5eea-ae38-4359-922d-4e4cbdfa8fe2.html,,,,,, Trimagnesium dicitrate,3344-18-1,"The key study for acute oral toxicity was read across from citric acid, which reports an LD50 value of 5400mg/kg (Roche, 1981; rel 2). [PLACEHOLDER FOR DERMAL TOX READ ACROSS]. Data for the acute toxicity inhalation endpoint was waived, since reliable data was available for the acute oral and dermal endpoints. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b2fd36a-cf2a-4512-b53d-0835f3d65b6a/documents/IUC5-6a05af5e-e5f3-4bd1-ba9b-8372311c9aa0_655e5eea-ae38-4359-922d-4e4cbdfa8fe2.html,,,,,, Trimagnesium dicitrate,3344-18-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9b2fd36a-cf2a-4512-b53d-0835f3d65b6a/documents/IUC5-6a05af5e-e5f3-4bd1-ba9b-8372311c9aa0_655e5eea-ae38-4359-922d-4e4cbdfa8fe2.html,,oral,LD50,"5,400 mg/kg bw",, Trimanganese tetraoxide,1317-35-7,"Mn3O4 has low oral toxicity when given to adult rats over a sub-acute period. Mn3O4 has been demonstrated to have low toxicity at low air concentrations (equivalent to 1 mg respirable Mn/m3) (Ulrich et al 1979). No dermal studies are available, but absorption of Mn3O4 through skin is not expected based on its very poor solubility in water. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/369ed6f5-e50c-4235-b26c-280b9679e8b5/documents/IUC5-1ff14493-c5ab-4f86-be65-742bde117f99_2d99e44c-0fe9-4a71-9f14-74b8b63109fe.html,,,,,, Trimanganese tetraoxide,1317-35-7,"ORALLD50 > 2000 mg/kg bw, OECD 420, EU Method B.1 bis, Pooles (2009)INHALATIONLC50 > 5.17 mg/L, OECD 403, EU Method B.2, Griffiths (2010) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/369ed6f5-e50c-4235-b26c-280b9679e8b5/documents/IUC5-67a4f3a3-805e-470f-b9f4-00101016d330_2d99e44c-0fe9-4a71-9f14-74b8b63109fe.html,,,,,, Trimanganese tetraoxide,1317-35-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/369ed6f5-e50c-4235-b26c-280b9679e8b5/documents/IUC5-67a4f3a3-805e-470f-b9f4-00101016d330_2d99e44c-0fe9-4a71-9f14-74b8b63109fe.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Trimanganese tetraoxide,1317-35-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/369ed6f5-e50c-4235-b26c-280b9679e8b5/documents/IUC5-67a4f3a3-805e-470f-b9f4-00101016d330_2d99e44c-0fe9-4a71-9f14-74b8b63109fe.html,,inhalation,LC50,5.17 mg/m3,no adverse effect observed, Trimebutine,39133-31-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): > 5000 mg/kg. (Literature) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/458e0733-0e7e-4a34-aebc-07c5693100b2/documents/2fd2125b-a612-4bcd-9104-0337214f602e_b3dfb6ff-ccf2-4175-869a-39ffb329a6e6.html,,,,,, "Trimethoxy(2,4,4-trimethylpentyl)silane",34396-03-7," Oral: OECD 422, rat: NOAEL (systemic) = 50 mg/kg bw/day OECD 408, rat: NOAEL (systemic) ≥150 mg/kg bw/day Inhalation: OECD 412, rat: NOAEC (systemic) = 2890 mg/m³ air ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f153cec8-41cb-49e2-b699-3a3eeac6e4b5/documents/627a1111-41e3-4a6d-9cea-63be8e2c9e0e_f4178916-8232-4536-92ab-9dd70868bb5a.html,,,,,, "Trimethoxy(2,4,4-trimethylpentyl)silane",34396-03-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f153cec8-41cb-49e2-b699-3a3eeac6e4b5/documents/627a1111-41e3-4a6d-9cea-63be8e2c9e0e_f4178916-8232-4536-92ab-9dd70868bb5a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Trimethoxy(2,4,4-trimethylpentyl)silane",34396-03-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f153cec8-41cb-49e2-b699-3a3eeac6e4b5/documents/627a1111-41e3-4a6d-9cea-63be8e2c9e0e_f4178916-8232-4536-92ab-9dd70868bb5a.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"2,890 mg/m3",,rat "Trimethoxy(2,4,4-trimethylpentyl)silane",34396-03-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f153cec8-41cb-49e2-b699-3a3eeac6e4b5/documents/627a1111-41e3-4a6d-9cea-63be8e2c9e0e_f4178916-8232-4536-92ab-9dd70868bb5a.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"2,890 mg/m3",no adverse effect observed,rat "Trimethoxy(2,4,4-trimethylpentyl)silane",34396-03-7,"Oral (OECD 423, GLP, RL1), rat: LD50 > 2000 mg/kg bw Inhalation (OECD 403, GLP, RL1), rat: LC50 > 11.2 mg/L (maximum attainable concentration)Dermal: No data available (data waiving according to Column 2 of REACH Annex VIII, Section 8.5.3) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f153cec8-41cb-49e2-b699-3a3eeac6e4b5/documents/f516f94f-0ecb-4a97-9881-5cde5caa93ac_f4178916-8232-4536-92ab-9dd70868bb5a.html,,,,,, "Trimethoxy(2,4,4-trimethylpentyl)silane",34396-03-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f153cec8-41cb-49e2-b699-3a3eeac6e4b5/documents/f516f94f-0ecb-4a97-9881-5cde5caa93ac_f4178916-8232-4536-92ab-9dd70868bb5a.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Trimethoxy(2,4,4-trimethylpentyl)silane",34396-03-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f153cec8-41cb-49e2-b699-3a3eeac6e4b5/documents/f516f94f-0ecb-4a97-9881-5cde5caa93ac_f4178916-8232-4536-92ab-9dd70868bb5a.html,,inhalation,LC50,> 11.2 mg/L,no adverse effect observed, Trimethoxy(2-methylpropyl)silane,18395-30-7,"There are no repeated dose toxicity data on trimethoxy(2-methylpropyl)silane or its hydrolysis product, (2-methylpropyl)silanetriol, so good quality data for the related substance triethoxyisobutylsilane (CAS 17980-47-1) have been used to assess the general systemic toxicity of trimethoxy(2-methylpropyl)silane. In a rat 28-day oral gavage study conducted using a protocol similar to OECD 407 and to GLP (Huntingdon Research Centre, 1988) the NOAEL for triethoxyisobutylsilane was at least 1000 mg/kg bw/day, as there were no adverse toxicological findings at this the only dose tested. In a repeated nose-only inhalation study, conducted to OECD 413 and to GLP (Safepharm Laboratories, Ltd., 1992a) the NOAEC for triethoxyisobutylsilane was at least 2.54 mg/l in rats. The key and supporting studies for triethoxyisobutylsilane show that this substance has a low potential to cause adverse health effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acc89a36-a4c4-411f-974a-e4b554500158/documents/IUC5-7af73c57-63d9-405e-9d10-7893d7566da8_f270ebed-d9a9-45f0-948c-a8974551b19d.html,,,,,, Trimethoxy(2-methylpropyl)silane,18395-30-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acc89a36-a4c4-411f-974a-e4b554500158/documents/IUC5-7af73c57-63d9-405e-9d10-7893d7566da8_f270ebed-d9a9-45f0-948c-a8974551b19d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Trimethoxy(2-methylpropyl)silane,18395-30-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acc89a36-a4c4-411f-974a-e4b554500158/documents/IUC5-7af73c57-63d9-405e-9d10-7893d7566da8_f270ebed-d9a9-45f0-948c-a8974551b19d.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,"2,540 mg/m3",,rat Trimethoxy(2-methylpropyl)silane,18395-30-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/acc89a36-a4c4-411f-974a-e4b554500158/documents/IUC5-7af73c57-63d9-405e-9d10-7893d7566da8_f270ebed-d9a9-45f0-948c-a8974551b19d.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"2,540 mg/m3",no adverse effect observed,rat Trimethoxy(2-methylpropyl)silane,18395-30-7,"In the key acute oral toxicity study (Hüls Prüfinstitut für Toxikologie, 1993a) conducted to OECD test guideline (now deleted 401) and GLP, the oral LD50 was greater than 2000 mg/kg bw in male and female rats. Within the first three hours after administration in males and the first six hours in females, there were signs of toxicity. Within three hours the signs were ruffled fur, crouching posture, mild sedation, ataxia, and swaying motion. By five to six hours there were no signs in 8/10 animals. Six hours after administration, one female had signs of severe toxicity (ruffled fur, medium to heavy sedation, ataxia, prone position, hypothermia, laboured breathing, closed eyes and chromodacryorrhea. While all other animals ate their food, after three hours this animal still refused to eat. After 24 hours there were no signs of toxicity in any of the animals. In the key acute inhalation study (that was comparable to OECD 403 and to GLP (DCC, 1984), the LC50 for Dow Corning X1-2204 (isobutyltrimethoxysilane) was greater than 1525 ppm (11 mg/l) (the only concentration tested) in Sprague-Dawley rats. The animals were lethargic and unresponsive during the exposure period. However, on removal from the chamber, the animals quickly recovered and did not show any stress or signs of toxicity during the 14-day observation period. There are no dermal data for the registration substance, but the skin irritation and skin sensitisation studies did not report any systemic effects. An acute dermal toxicity study is available for a related substance (triethoxy-(2-methylpropyl)silane) in which the LD50 was >2000 mg/kg bw (Huntingdon Research Centre, 1987b), confirming the low acute toxicity of the substance; the relevance of this substance is discussed further in Section 7.5. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acc89a36-a4c4-411f-974a-e4b554500158/documents/IUC5-9085d61e-25f3-446e-9bd0-c9a294594de1_f270ebed-d9a9-45f0-948c-a8974551b19d.html,,,,,, Trimethoxy(2-methylpropyl)silane,18395-30-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acc89a36-a4c4-411f-974a-e4b554500158/documents/IUC5-9085d61e-25f3-446e-9bd0-c9a294594de1_f270ebed-d9a9-45f0-948c-a8974551b19d.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Trimethoxy(2-methylpropyl)silane,18395-30-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/acc89a36-a4c4-411f-974a-e4b554500158/documents/IUC5-9085d61e-25f3-446e-9bd0-c9a294594de1_f270ebed-d9a9-45f0-948c-a8974551b19d.html,,inhalation,LC50,"11,000 mg/m3",no adverse effect observed, "Trimethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane",85857-16-5," Acute oral toxicity: no effects observed at 2000 mg/kg bw, the highest dose tested (equivalent to OECD 401, GLP). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a39c83f-bfb4-4fd1-af3a-3230dbdb1964/documents/6c3beeee-c51e-4185-bf56-8a67348601fd_0dea2bb9-a512-478f-a6da-b31268c66b0c.html,,,,,, "Trimethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane",85857-16-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a39c83f-bfb4-4fd1-af3a-3230dbdb1964/documents/6c3beeee-c51e-4185-bf56-8a67348601fd_0dea2bb9-a512-478f-a6da-b31268c66b0c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Trimethoxyoctadecylsilane,3069-42-9,"Oral (OECD 401), rat: LD50 > 5002 mg/kg bwInhalation: No data availableDermal (OECD 402), rabbit: LD50 > 2000 mg/kg bw ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc67e7e7-598a-4222-a68e-65a49a39b44f/documents/ef28c44c-0a1d-464f-b884-e70cbb307344_597bbcc2-74d1-4100-90b8-75fa385d8ab4.html,,,,,, Trimethoxyoctadecylsilane,3069-42-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc67e7e7-598a-4222-a68e-65a49a39b44f/documents/ef28c44c-0a1d-464f-b884-e70cbb307344_597bbcc2-74d1-4100-90b8-75fa385d8ab4.html,,oral,LD50,"5,002 mg/kg bw",no adverse effect observed, Trimethoxyoctadecylsilane,3069-42-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc67e7e7-598a-4222-a68e-65a49a39b44f/documents/ef28c44c-0a1d-464f-b884-e70cbb307344_597bbcc2-74d1-4100-90b8-75fa385d8ab4.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Trimethoxyphenylsilane,2996-92-1,"Sub-acute (oral) Repeated dose toxicity (OECD TG 422, rat): LOAEL = 100 mg/kg bw/day   Sub-acute (inhalation) Repeated dose toxicity (OECD TG 412, rat): NOAEC ≥ 620 mg/m³   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2322800b-4adc-4537-b0cf-a6dacfdc3461/documents/ecb3a4df-8588-433c-9877-7c5a1264e72c_666a5fb9-1d7f-4052-a1f9-8ee5f1d0aebe.html,,,,,, Trimethoxyphenylsilane,2996-92-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2322800b-4adc-4537-b0cf-a6dacfdc3461/documents/ecb3a4df-8588-433c-9877-7c5a1264e72c_666a5fb9-1d7f-4052-a1f9-8ee5f1d0aebe.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat Trimethoxyphenylsilane,2996-92-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2322800b-4adc-4537-b0cf-a6dacfdc3461/documents/ecb3a4df-8588-433c-9877-7c5a1264e72c_666a5fb9-1d7f-4052-a1f9-8ee5f1d0aebe.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,>= 620 mg/m3,,rat Trimethoxyphenylsilane,2996-92-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2322800b-4adc-4537-b0cf-a6dacfdc3461/documents/ecb3a4df-8588-433c-9877-7c5a1264e72c_666a5fb9-1d7f-4052-a1f9-8ee5f1d0aebe.html,Repeated dose toxicity – local effects,inhalation,NOAEC,>= 620 mg/m3,no adverse effect observed,rat Trimethoxyphenylsilane,2996-92-1,Oral (OECD TG 425): LD50 (rat) = 1049 mg/kg bw Dermal (similar to OECD TG 402): LD50 (rabbit) = 3014 mg/kg bw (RA from CAS 780-69-8) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2322800b-4adc-4537-b0cf-a6dacfdc3461/documents/72f32ce8-a536-4e9a-8aec-30c3901e2f47_666a5fb9-1d7f-4052-a1f9-8ee5f1d0aebe.html,,,,,, Trimethoxyphenylsilane,2996-92-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2322800b-4adc-4537-b0cf-a6dacfdc3461/documents/72f32ce8-a536-4e9a-8aec-30c3901e2f47_666a5fb9-1d7f-4052-a1f9-8ee5f1d0aebe.html,,oral,LD50,"1,049 mg/kg bw",adverse effect observed, Trimethoxyphenylsilane,2996-92-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2322800b-4adc-4537-b0cf-a6dacfdc3461/documents/72f32ce8-a536-4e9a-8aec-30c3901e2f47_666a5fb9-1d7f-4052-a1f9-8ee5f1d0aebe.html,,dermal,LD50,"3,014 mg/kg bw",no adverse effect observed, Trimethoxypropylsilane,1067-25-0,"In order to fulfil the standard information requirements, a GLP-compliant 90-day repeated dose toxicity study in rats via the inhalation route following OECD 413 is proposed according to Annex IX, Column 1, Section 8.6.2. In the interim, read-across to the structural analogue substance trimethoxy(methyl)silane (CAS 1185-55-3) has been used to assess the systemic toxicity of trimethoxy(propyl)silane. Studies on trimethoxy(methyl)silane (CAS 1185-55-3): Inhalation, subchronic (OECD 413 in rats): NOAEC = 560 mg/m³ (100 ppm) Oral, subacute (OECD 422 in rats): NOAEL = 50 mg/kg bw/day Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.6, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VIII-IX, 8.6, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The available information comprises an adequate and reliable study, and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.6, of Regulation (EC) No 1907/2006. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b40d444-6a61-4565-954a-aae7f2c8ca21/documents/3c1baf3b-4ca1-4630-ba9a-33e688437c57_39ed4266-ac3e-41c2-8e48-a17eb33f7eb3.html,,,,,, Trimethoxypropylsilane,1067-25-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b40d444-6a61-4565-954a-aae7f2c8ca21/documents/3c1baf3b-4ca1-4630-ba9a-33e688437c57_39ed4266-ac3e-41c2-8e48-a17eb33f7eb3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Trimethoxypropylsilane,1067-25-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8b40d444-6a61-4565-954a-aae7f2c8ca21/documents/3c1baf3b-4ca1-4630-ba9a-33e688437c57_39ed4266-ac3e-41c2-8e48-a17eb33f7eb3.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,560 mg/m3,,rat Trimethoxypropylsilane,1067-25-0,"Oral (OECD 401): Males LD50 > 5170 mg/kg bw (limit test); Females LD50 = 5170 mg/kg bw (estimated) Inhalation (OECD 403): LC50 > 22200 mg/m³ Dermal: There are no measured acute dermal toxicity data available (data waiving according to Column 2 of REACH Annex VIII, Section 8.5.3). Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The available key study is considered adequate and reliable (Klimisch score 2), and is thus sufficient to fulfil the standard information requirements set out in Annex VII, 8.5.1, of Regulation (EC) No 1907/2006. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The available key study is considered adequate and reliable (Klimisch score 1), and is thus sufficient to fulfil the standard information requirements set out in Annex VIII, 8.5.1, of Regulation (EC) No 1907/2006. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b40d444-6a61-4565-954a-aae7f2c8ca21/documents/9944afe5-4523-40e7-8b4f-f583a2fee476_39ed4266-ac3e-41c2-8e48-a17eb33f7eb3.html,,,,,, Trimethoxypropylsilane,1067-25-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b40d444-6a61-4565-954a-aae7f2c8ca21/documents/9944afe5-4523-40e7-8b4f-f583a2fee476_39ed4266-ac3e-41c2-8e48-a17eb33f7eb3.html,,oral,LD50,"5,170 mg/kg bw",adverse effect observed, Trimethoxypropylsilane,1067-25-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8b40d444-6a61-4565-954a-aae7f2c8ca21/documents/9944afe5-4523-40e7-8b4f-f583a2fee476_39ed4266-ac3e-41c2-8e48-a17eb33f7eb3.html,,inhalation,LC50,"> 22,200 mg/m3",adverse effect observed, Trimethoxysilane,2487-90-3," The key study (BRRC, 1995) for repeated dose toxicity via the inhalation route was similar to OECD Test Guideline 413 and in compliance with GLP, except that very low concentrations were used. There were no local nor systemic adverse effects up to the highest dose tested (0.5 ppm). In other similarly reliable studies the NOAECs were 0.5 and 0.2 ppm, with effects observed at 5 and 1 ppm, respectively. However, in those studies that tested above 0.5 ppm, it does appear that most of the effects are a consequence of the severe local effects on the respiratory tract and that no distinct systemic effects were observed. There are no reliable data available that investigate the potential for trimethoxysilane to cause systemic toxicity following repeated dermal or oral exposure. Further testing for these endpoints is not relevant for the current Annex requirements. Furthermore, reliable measured data are available for the ultimate hydrolysis product, silicic acid, which indicate no hazard for systemic toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96525686-9ac0-4040-9973-7672397e96fb/documents/cce35f45-bfc0-4386-9fc7-2785e42f9888_fe33d710-1f6b-4bc1-a3dd-dbea621c94c4.html,,,,,, Trimethoxysilane,2487-90-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96525686-9ac0-4040-9973-7672397e96fb/documents/cce35f45-bfc0-4386-9fc7-2785e42f9888_fe33d710-1f6b-4bc1-a3dd-dbea621c94c4.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,>= 0.51 ,, Trimethoxysilane,2487-90-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/96525686-9ac0-4040-9973-7672397e96fb/documents/cce35f45-bfc0-4386-9fc7-2785e42f9888_fe33d710-1f6b-4bc1-a3dd-dbea621c94c4.html,Repeated dose toxicity – local effects,inhalation,NOAEC,2.5 mg/m3,adverse effect observed,rat Trimethoxysilane,2487-90-3,"In a key acute inhalation study, which was conducted in a manner similar to OECD 403 and in compliance with GLP, Sprague Dawley rats were exposed to trimethoxysilane (CAS 2487-90-3, EC 219-637-2) with a resulting LC50 = 60 ppm (~300 mg/m3) (BRRC, 1988b, reliability 1).   In a key acute dermal study, conducted in a manner similar to OECD 402 though not in compliance with GLP, rabbits were exposed by occlusive application to trimethoxysilane. The dermal LD50 was 7.46 l/kg in male rabbits (~ 7087 mg/kg bw) and 6.73 ml/kg bw in female rabbits (~ 6393 mg/kg bw) (BRRC, 1988c, reliability 2).   A number of acute oral toxicity studies were available but a key study was not identified. It is not necessary to conduct further testing for this enspoint since the substance is classified as corrosive to skin.  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96525686-9ac0-4040-9973-7672397e96fb/documents/97208a07-72fa-4699-95a8-49c0ad12c0cb_fe33d710-1f6b-4bc1-a3dd-dbea621c94c4.html,,,,,, Trimethoxysilane,2487-90-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96525686-9ac0-4040-9973-7672397e96fb/documents/97208a07-72fa-4699-95a8-49c0ad12c0cb_fe33d710-1f6b-4bc1-a3dd-dbea621c94c4.html,,dermal,LD50,"6,393 mg/kg bw",no adverse effect observed, Trimethoxysilane,2487-90-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/96525686-9ac0-4040-9973-7672397e96fb/documents/97208a07-72fa-4699-95a8-49c0ad12c0cb_fe33d710-1f6b-4bc1-a3dd-dbea621c94c4.html,,inhalation,LC50,300 mg/m3,adverse effect observed, Trimethoxyvinylsilane,2768-02-7," In the key oral repeated dose study (combined repeated dose toxicity study with the reproduction / developmental toxicity screening test, conducted according to OECD Test Guideline 422 and in compliance with GLP (Hashima Laboratory, 2005)), administration of trimethoxy(vinyl)silane to rats at dose levels of 62.5, 250 or 1000 mg/kg bw/day lead to significant histopathological changes in the urinary bladder of males and females, which were not reversible at the end of the recovery period, in the higher dose groups of 250 and 1000 mg/kg bw/day. Administration of 62.5 mg/kg bw/day did not lead to organ damage including irreversible morphological effects permanently impairing the function of the organ/tissue (reversibility after recovery period). Also, no other effects such as necrosis or other cell death were reported, which could contribute to the degeneration of the metabolically functional tissue. The No Observed Adverse Effect Level (NOAEL) was therefore determined to be 62.5 mg/kg bw/day. The Lowest Observed Adverse Effect Level (LOAEL) was 250 mg/kg bw/day, based on the histopathological changes in the urinary bladder observed in all animals (males and females) at this dose level. For purposes of identifying the oral CSA value, the systemic NOAEL of 40 mg/kg bw/day from the extended one-generation reproductive toxicity study (EOGRTS, OECD Test Guideline 443) is selected. As discussed further in Section 5.9.3 Summary and discussion of reproductive toxicity, the NOAEL for systemic toxicity for the parental (P0 and P1 [F1 Cohort 1B]) animals in this study was concluded to be 40 mg/kg bw/day based on test substance-related effects in the urinary system (kidney, bladder) at 100 and 300 mg/kg bw/day (BSL Bioservice, 2021). In the key 14-week whole-body inhalation study (Bushy Run Research Center, 1990), conducted using a protocol similar to OECD Test Guideline 413 and in compliance with GLP, in which rats were exposed to nominal concentration of trimethoxy(vinyl)silane at 10, 100 or 400 ppm, minimal to mild alterations in body weight, water consumption, urinalysis, organ weights, and bladder and kidney histopathology were observed at the highest concentration of 400 ppm. The clinical chemistry findings in males at 400 mg/kg bw/day (lower osmolarity and electrolyte concentrations, and decreased creatinine clearance) are consistent with the renal histopathology at this dose. At a concentration of 100 ppm there were some body weight gain reductions in females, but they were less than 10% and not always statistically significant, and there were no such finding in males; males had mild effects on urine osmolality and urine volume in week one only and there were no associated organ weight changes, macroscopic or microscopic findings. There were no findings at the end of the recovery period. Therefore, the findings at 100 ppm were concluded not to be adverse and the NOAEC in Fischer 344 rats was therefore 100 ppm (equivalent to 605 mg/m3). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b910dcd5-91de-4161-84c4-fc2015e0cc13/documents/c8ee1c51-f0f3-4dc3-bdaf-6515b8ed7649_6e1f89f7-b83b-42a3-95e9-4f492d893391.html,,,,,, Trimethoxyvinylsilane,2768-02-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b910dcd5-91de-4161-84c4-fc2015e0cc13/documents/c8ee1c51-f0f3-4dc3-bdaf-6515b8ed7649_6e1f89f7-b83b-42a3-95e9-4f492d893391.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat Trimethoxyvinylsilane,2768-02-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b910dcd5-91de-4161-84c4-fc2015e0cc13/documents/c8ee1c51-f0f3-4dc3-bdaf-6515b8ed7649_6e1f89f7-b83b-42a3-95e9-4f492d893391.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,605 mg/m3,,rat Trimethoxyvinylsilane,2768-02-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b910dcd5-91de-4161-84c4-fc2015e0cc13/documents/c8ee1c51-f0f3-4dc3-bdaf-6515b8ed7649_6e1f89f7-b83b-42a3-95e9-4f492d893391.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"2,421 mg/m3",no adverse effect observed,rat Trimethoxyvinylsilane,2768-02-7," In the key acute oral toxicity study, conducted according to OECD Test Guideline 401 but not in compliance with GLP, the concluded LD50 values for male and female rats were 7.34 ml/kg and 7.46 ml/kg (equivalent to 6899 and 7012 mg/kg bw based on relative density of 0.94 g/cm3), respectively (Bushy Run Research Centre, 1984a). In the key acute inhalation toxicity study, conducted according to OECD Test Guideline 403 but not in compliance with GLP, an acute inhalation LC50 value of 2773 ppm (16.8 mg/L) was determined for rats (Bushy Run Research Centre, 1986). In the key acute dermal toxicity study, conducted according to a protocol similar to OECD Test Guideline 402 but not in compliance with GLP, LD50 (rabbit) values of 3.36 ml/kg bw for females and 4 ml/kg bw for males (equivalent to 3158 and 3760 mg/kg bw, respectively, based on relative density of 0.94 g/cm3) were determined (Bushy Run Research Centre, 1984b). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b910dcd5-91de-4161-84c4-fc2015e0cc13/documents/4e95cf16-7525-4821-8b2b-e5b732314203_6e1f89f7-b83b-42a3-95e9-4f492d893391.html,,,,,, Trimethoxyvinylsilane,2768-02-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b910dcd5-91de-4161-84c4-fc2015e0cc13/documents/4e95cf16-7525-4821-8b2b-e5b732314203_6e1f89f7-b83b-42a3-95e9-4f492d893391.html,,oral,LD50,"6,899 mg/kg bw",no adverse effect observed, Trimethoxyvinylsilane,2768-02-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b910dcd5-91de-4161-84c4-fc2015e0cc13/documents/4e95cf16-7525-4821-8b2b-e5b732314203_6e1f89f7-b83b-42a3-95e9-4f492d893391.html,,dermal,LD50,"3,158 mg/kg bw",no adverse effect observed, Trimethoxyvinylsilane,2768-02-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b910dcd5-91de-4161-84c4-fc2015e0cc13/documents/4e95cf16-7525-4821-8b2b-e5b732314203_6e1f89f7-b83b-42a3-95e9-4f492d893391.html,,inhalation,LC50,"16,800 mg/m3",adverse effect observed, "Trimethyl benzene-1,2,4-tricarboxylate",2459-10-1, 28 -day sub-acute toxicity: NOAEL 1000 mg/kg/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/587ece16-f069-481f-8cc6-9897736907bf/documents/90384208-c19c-4410-85e7-7dbf6467ed95_27935ec4-7022-44cc-ade8-1a8a3194c70f.html,,,,,, "Trimethyl benzene-1,2,4-tricarboxylate",2459-10-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/587ece16-f069-481f-8cc6-9897736907bf/documents/90384208-c19c-4410-85e7-7dbf6467ed95_27935ec4-7022-44cc-ade8-1a8a3194c70f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Trimethyl benzene-1,2,4-tricarboxylate",2459-10-1, Oral - LD50 = 12232 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/587ece16-f069-481f-8cc6-9897736907bf/documents/452d5cf9-044f-4f86-8b8b-3f8aeacdf87b_27935ec4-7022-44cc-ade8-1a8a3194c70f.html,,,,,, "Trimethyl benzene-1,2,4-tricarboxylate",2459-10-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/587ece16-f069-481f-8cc6-9897736907bf/documents/452d5cf9-044f-4f86-8b8b-3f8aeacdf87b_27935ec4-7022-44cc-ade8-1a8a3194c70f.html,,oral,LD50,"12,232 mg/kg bw",adverse effect observed, "Trimethyl benzene-1,2,4-tricarboxylate",2459-10-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/587ece16-f069-481f-8cc6-9897736907bf/documents/452d5cf9-044f-4f86-8b8b-3f8aeacdf87b_27935ec4-7022-44cc-ade8-1a8a3194c70f.html,,dermal,LD50,"2,460 mg/kg bw",, Trimethyl orthoacetate,1445-45-0," Trimethyl orthoacetate is rapidly hydrolysed to methanol (CAS no. 67 -56 -1) and methyl acetate, which further hydrolyses to acetic acid (CAS no. 64 -19 -7) as final reaction product in the presence of water or moisture at pH 4, 7 and 9 (< 2.4 h 50°C). Under neutral (pH 7) and acidic (pH 4) conditions, the half-life was < 1 h. Accordingly, reliable data of the hydrolysis products methanol and acetic acid are used to address the endpoint, which is entirely appropriate to draw conclusions on the repeated dose toxiciy of Trimethyl orthoacetate to mammals. For each hydrolysis product results on the repeated dose toxicity are presented for the most appropriate route of administration, based on respective physical chemical parameters. 1. Methanol - Repeated dose toxicity: chronic (12 months) study, inhalation (vapour), rat ( Fischer 344/DuCrj) m/f, 3 concentrations (0.013, 0.13 and 1.3 mg/L air, corresponding to 10, 100 and 1000 ppm) (OECD TG 453): NOAEC = 1.3 mg/L air, NOEC = 0.13 mg/L air (nominal, m/f) - Repeated dose toxicity: chronic (12 months) study, inhalation (vapour), mouse ( B6C3F1) m/f, 3 concentrations (0.013, 0.13 and 1.3 mg/L air, corresponding to 10, 100 and 1000 ppm) (OECD TG 453): NOAEC = 1.3 mg/L air, NOEC = 0.13 mg/L air (nominal, m/f) 2. Acetic Acid - Repeated dose toxicity: subacute (8 weeks) study, oral (feed), rat (spontaneously hypertensive rats) male (no guideline followed, non-GLP): NOAEL = 290 mg/kg bw/day (nominal, male) - Repeated dose toxicity: subchronic (6 months) study, oral (feed), pig (no guideline followed, non-GLP): NOAEL = 450 mg/kg bw/day (nominal) - Repeated dose toxicity: subacute (4 weeks) study, oral (feed), rat (Wistar, vitamin B-12 deficient) (no guideline followed, non-GLP): NOAEL =3.58% sodium acetate (1.58% acetate moiety) with or without vitamin B12, corresponding to a NOAEL of 2370 mg/kg bw/day for the acetate moiety (nominal, male) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3d9f940-05e7-4579-910d-f7c4c9befdb6/documents/4c1446e5-0dab-41dd-bbe2-6a8b48962c8f_b91e8297-eed8-479a-a038-7c06b2210c68.html,,,,,, Trimethyl orthoacetate,1445-45-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3d9f940-05e7-4579-910d-f7c4c9befdb6/documents/4c1446e5-0dab-41dd-bbe2-6a8b48962c8f_b91e8297-eed8-479a-a038-7c06b2210c68.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,290 mg/kg bw/day,,rat Trimethyl orthoacetate,1445-45-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3d9f940-05e7-4579-910d-f7c4c9befdb6/documents/4c1446e5-0dab-41dd-bbe2-6a8b48962c8f_b91e8297-eed8-479a-a038-7c06b2210c68.html,Chronic toxicity – systemic effects,inhalation,NOAEC,"1,300 mg/m3",,mouse Trimethyl orthoacetate,1445-45-0," Acute Toxicity oral: standard acute method (rigid stomach tube), rat (Wistar) m/f (OECD TG 401, GLP): LD50 > 2000 mg/kg b.w. (nominal) m/f Acute Toxicity dermal: standard acute method (semiocclusive coverage), rat (Wistar) m/f (OECD 402, GLP): LD50 > 2000 mg/kg b.w. (nominal) m/f ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3d9f940-05e7-4579-910d-f7c4c9befdb6/documents/f172e48e-77f3-43f4-80b7-80b2e84a034e_b91e8297-eed8-479a-a038-7c06b2210c68.html,,,,,, Trimethyl orthoacetate,1445-45-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3d9f940-05e7-4579-910d-f7c4c9befdb6/documents/f172e48e-77f3-43f4-80b7-80b2e84a034e_b91e8297-eed8-479a-a038-7c06b2210c68.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Trimethyl orthoacetate,1445-45-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3d9f940-05e7-4579-910d-f7c4c9befdb6/documents/f172e48e-77f3-43f4-80b7-80b2e84a034e_b91e8297-eed8-479a-a038-7c06b2210c68.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Trimethyl orthoformate,149-73-5,"Oral, ALD50, male rat 5000 mg/kg bw (DuPont Haskell, Waritz 1966) Inhalation, LC50 vapour, male rat 40 mg/L (DuPont Haskell, Kwon 1966) Dermal, ALD50, rabbit >3400 mg/kg bw (DuPont Haskell, Majkut 1966) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1bd9a3a-89ef-46dd-b5f6-a7bda8221cce/documents/0308bb8f-9883-4d20-8d28-373140388019_4f4265a1-06ce-4977-a81f-68f0c0dcfa50.html,,,,,, Trimethyl orthoformate,149-73-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1bd9a3a-89ef-46dd-b5f6-a7bda8221cce/documents/0308bb8f-9883-4d20-8d28-373140388019_4f4265a1-06ce-4977-a81f-68f0c0dcfa50.html,,oral,LD50,"5,000 mg/kg bw",, Trimethyl orthoformate,149-73-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1bd9a3a-89ef-46dd-b5f6-a7bda8221cce/documents/0308bb8f-9883-4d20-8d28-373140388019_4f4265a1-06ce-4977-a81f-68f0c0dcfa50.html,,dermal,LD50,"3,400 mg/kg bw",, Trimethyl orthoformate,149-73-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1bd9a3a-89ef-46dd-b5f6-a7bda8221cce/documents/0308bb8f-9883-4d20-8d28-373140388019_4f4265a1-06ce-4977-a81f-68f0c0dcfa50.html,,inhalation,LC50,"40,000 mg/m3",, "Trimethyl[2-(phosphonooxy)ethyl]ammonium chloride, calcium salt (1:1)",4826-71-5," The available data refer to the degradation products of calcium phosphorylcholine chloride (choline and inorganic phosphate): - Key study. Method similar to OECD 452. The lethal dose 0 (LD0) of Choline chloride is 500 mg/kg/day (1%) in rats, after 72-week oral administration. - Key study. Method similar to OECD 408 and according to ISO 10993. Beta-calcium pyrophosphate has a NOAEL higher than 30 mg/kg/day in rats, after 90-day oral administration. - Key study. OECD 408. Tetrasodium pyrophosphate was found to have a NOAEL of  500 mg/kg/day and the target organ appears to be the kidney in rats, after 90-day oral administration. - Supporting study: Phosphoric acid has a NOAEL>386 mg/kg/day in rats, after administration in diet for more than twelve months. Based on this information, it can be concluded that the substance phosphoryl choline chloride has a ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f7333b9-c729-42ce-bc07-8ed7d1f214a2/documents/1d023f33-e99f-45ae-a5a6-d54a6f3cc78c_2211355e-6056-4410-be5c-3ecc462a5bea.html,,,,,, "Trimethyl[2-(phosphonooxy)ethyl]ammonium chloride, calcium salt (1:1)",4826-71-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0f7333b9-c729-42ce-bc07-8ed7d1f214a2/documents/1d023f33-e99f-45ae-a5a6-d54a6f3cc78c_2211355e-6056-4410-be5c-3ecc462a5bea.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Trimethyl[2-(phosphonooxy)ethyl]ammonium chloride, calcium salt (1:1)",4826-71-5," Acute oral toxicity: Key study: OECD 423 and EU method B.1 tris. Klimish score 1. GLP study. The LD50 of the test item is higher than 2000 mg/kg body weight by oral route in the rat. The LD50 cut-off of the test item may be considered to be higher than 5000 mg/kg body weight by oral route in the rat. Acute dermal toxicity: Key study: OECD 402 and EU method B.3. Klimish score 1. GLP study. The dermal LD50 of the test item in rats is greater than 2000 mg/kg bw. Acute toxicity: inhalation. Data waiving (scientifically not necessary / other information available): In accordance with column 2 of REACH Annex VIII, the study does not need to be conducted because exposure of humans via inhalation is likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols or droplets of an inhalable size. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f7333b9-c729-42ce-bc07-8ed7d1f214a2/documents/93cf69a2-428f-4c30-ad40-7c521db4f229_2211355e-6056-4410-be5c-3ecc462a5bea.html,,,,,, "Trimethyl[2-(phosphonooxy)ethyl]ammonium chloride, calcium salt (1:1)",4826-71-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f7333b9-c729-42ce-bc07-8ed7d1f214a2/documents/93cf69a2-428f-4c30-ad40-7c521db4f229_2211355e-6056-4410-be5c-3ecc462a5bea.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Trimethyl[2-(phosphonooxy)ethyl]ammonium chloride, calcium salt (1:1)",4826-71-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0f7333b9-c729-42ce-bc07-8ed7d1f214a2/documents/93cf69a2-428f-4c30-ad40-7c521db4f229_2211355e-6056-4410-be5c-3ecc462a5bea.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Trimethylacetic anhydride,1538-75-6, LD50 (oral) > 300 -2000 mg/kg bw (Brockes 2016) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd691435-986d-45b7-bd22-bcbacbf7e0a5/documents/3f95e894-8591-4806-96b6-3b4a7cb37a8a_ac5415f4-74dc-4c62-ae19-400e24a9d29f.html,,,,,, Trimethylacetic anhydride,1538-75-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cd691435-986d-45b7-bd22-bcbacbf7e0a5/documents/3f95e894-8591-4806-96b6-3b4a7cb37a8a_ac5415f4-74dc-4c62-ae19-400e24a9d29f.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, Trimethylaluminium,75-24-1,"Trimethylaluminium is classified as Pyr. Liquid 1, Water React. Flam. Gas 1 and Skin Corr. 1B. Therefore, the substance ignites upon exposure to air, reacts violently with water and causes severe burns to the skin and eyes. Consequently, it is not technically feasible to conduct toxicological studies with this substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fbea3812-bae7-4d95-a725-0b9ae203b0a6/documents/IUC5-a2d50743-a870-40ad-aa6f-6c40d978c7a9_f563906b-09e3-4e2e-9268-4d8263a51610.html,,,,,, Trimethylaluminium,75-24-1,"Trimethylaluminium is classified as Pyr. Liquid 1, Water React. Flam. Gas 1 and Skin Corr. 1B. Therefore, the substance ignites upon exposure to air, reacts violently with water and causes severe burns to the skin and eyes. Consequently, it is not technically feasible to conduct toxicological studies with this substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fbea3812-bae7-4d95-a725-0b9ae203b0a6/documents/IUC5-4bd0594a-940b-437e-b1ba-4fc96b7462ce_f563906b-09e3-4e2e-9268-4d8263a51610.html,,,,,, Trimethylamine,75-50-3," Oral: 1) Takashima et al. (2003) Combined repeat dose and reproductive/developmental toxicity screening test of trimethylamine by oral administration in rats. Rats, subchronic, gavage, 0, 8, 40, 200 mg/kg/day. Death of two males and one female in 200 mg/kg bw/day group. NOAEL (general) = 40 mg/kg bw TMA 2) Data on the read across substance trimethylamine hydrochloride: Amoore et al. (1978) repeated dose toxicity of trimethylamine hydrochloride in male Sprague-Dawley rats (90-day study, 0.04. 0.08, 0.16, 0.31, and 0.62 % trimethylamine hydrochloride in diet (corresponding to 0, 20, 40, 79, 150 and 310 mg/kg bw of trimethylamine). NOAEL of 0.16% diet TMA-HCl (= 130 mg/kg bw/day TMA-HCl (rounded from 128) = 79 mg/kg bw TMA) was established. Inhalation: 1) Rotenberg and Mashbits (1967) On the toxic effect of low trimethylamine concentrations, rats chronic, inhalation of 5 hours per day for 7 month, concentrations of 0.025 and 0.075 mg/L. 2) E. I. du Pont de Nemours & Company (1983) Subacute inhalation toxicity of anhydrous trimethylamine, male rats, subacute, concentrations 25 and 75 mg/m³, nose-only inhalation, 6 hours per day, 5 days a week, concentrations were 74, 240, and 760 ppm 3) Kinney et.al. (1990) Inhalation Toxicology of Trimethylamine, male rats, subacute, nose-only inhalation, 6 hours per day, 5 days a week, concentrations were 75, 250, and 750 ppm. No classification and labelling (STOT-RE) is warranted. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98eb44c9-7b9c-40b1-82d1-812a7b8469e5/documents/7769132c-e42e-420e-a76c-151d7f671a4b_890d41e1-e3a4-4a1d-9f51-5074f53c5ac6.html,,,,,, Trimethylamine,75-50-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98eb44c9-7b9c-40b1-82d1-812a7b8469e5/documents/7769132c-e42e-420e-a76c-151d7f671a4b_890d41e1-e3a4-4a1d-9f51-5074f53c5ac6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,40 mg/kg bw/day,,rat Trimethylamine,75-50-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98eb44c9-7b9c-40b1-82d1-812a7b8469e5/documents/7769132c-e42e-420e-a76c-151d7f671a4b_890d41e1-e3a4-4a1d-9f51-5074f53c5ac6.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,25 mg/m3,,rat Trimethylamine,75-50-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/98eb44c9-7b9c-40b1-82d1-812a7b8469e5/documents/7769132c-e42e-420e-a76c-151d7f671a4b_890d41e1-e3a4-4a1d-9f51-5074f53c5ac6.html,Repeated dose toxicity – local effects,inhalation,LOAEC,25 mg/m3,adverse effect observed,rat Trimethylamine,75-50-3," Oral: BASF AG, 1979. Bericht ueber die Gewerbetoxikologische Grundpruefung. Report Nr. 77/361; rats, gavage, 215, 316, 464, 681 and 1000 mg/kg bw Nagata, Toxicity Testing Reports of Environmental Chemicals, v. 8 (1), p 41-43, Crj: CD(SD)IGS rats, gavage, 125, 200, 320, 512, 820 and 1310 mg/kg bw Huntingdon Research Centre plc, Acute oral toxicity to rats of trimethylamine hydrochloride salt 58 % solution, HC/CFY (Remote Sprague-Dawley) rats, gavage, 2.0 g/kg bw Inhalation: Kinney, L. A. ; Burgess, B. A. ; Chen, H. C. ; Kennedy, G. L., 1990: Inhalation Toxicology of Trimethylamine BASF AG, 1979. Bericht über die Bestimmung der akuten Inhalationstoxizitaet LC50 von Trimethylamin als Gas bei 4stuendiger Exposition an Sprague-Dawley-Ratten, Report Nr. 77/361a, rats, whole body, 6.23 mg/L (analytical: 5.91 mg/L). E. I. du Pont de Nemours & Company (1983). Subacute inhalation toxicity of anhydrous trimethylamine. Koch et al., 1980 BASF AG, 1979. Industrial Hygiene orienting investigation, Report Nr. 77/361; rats, inhalation vapour, 3 min, 545 mg/L International Research and Developmental Corporation, 1992, Acute inhalation toxicity evaluation on trimethylamine in rats, rats, whole body, 6 min exposure: 18,600 ppm, 10 min exposure: 18,100 ppm, 20 min exposure were conducted at concentrations of 11,200; 12,700; 12,700; 14,100; 16,200 and 18,200 ppm, 60 min exposure were conducted at concentrations of 6,150; 7,100; 7,680; 7,720 and 8,170 ppm Gagnaire., et al (1989). Nasal Irritation and Pulmonary Toxicity of Aliphatic Amines in Mice. JOURNAL OF APPLIED TOXICOLOGY, VOL. 9(5), 301-304 (1989), nose only, 15 min, no lethal effect at the highest test concentration (169 mg/m3). Dermal: BASF AG, 1979. Industrial hygiene orientating investigation, Report Nr. 77/361; rats, occlusive, 5000 , 2000 or 400 mg/kg bw. BASF AG, 1979. Report Nr. 77/361, rats occlusive, 2000, 5000 mg/kg bw, 24 h ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98eb44c9-7b9c-40b1-82d1-812a7b8469e5/documents/dcec9963-40fa-4baa-a2d1-0f904b54031e_890d41e1-e3a4-4a1d-9f51-5074f53c5ac6.html,,,,,, Trimethylamine,75-50-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98eb44c9-7b9c-40b1-82d1-812a7b8469e5/documents/dcec9963-40fa-4baa-a2d1-0f904b54031e_890d41e1-e3a4-4a1d-9f51-5074f53c5ac6.html,,oral,LD50,766 mg/kg bw,adverse effect observed, Trimethylamine,75-50-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98eb44c9-7b9c-40b1-82d1-812a7b8469e5/documents/dcec9963-40fa-4baa-a2d1-0f904b54031e_890d41e1-e3a4-4a1d-9f51-5074f53c5ac6.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, Trimethylamine,75-50-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98eb44c9-7b9c-40b1-82d1-812a7b8469e5/documents/dcec9963-40fa-4baa-a2d1-0f904b54031e_890d41e1-e3a4-4a1d-9f51-5074f53c5ac6.html,,inhalation,LC50,"8,600 mg/m3",adverse effect observed, "Trimethylamine, N-oxide",1184-78-7,"Administration of Trimethylamine N-oxide dihydrate by once daily oral gavage in rats was associated with effects on body weight and/or food consumption in females only at 150 and 300 mg/kg bw/day. Based on the results of this study, the female no-observed-adverse-effect level (NOAEL) was considered to be 150 mg/kg bw/day (due to the body weight loss observed at 300 mg/ kg bw/day) and the NOAEL for the males was considered to be 300 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/956071fe-fffc-4e18-89b0-ff2865953b73/documents/e2f39e97-3c24-40cf-851b-b68c488806df_d9fdd2f5-ade8-4673-84ab-f02433317f2e.html,,,,,, "Trimethylamine, N-oxide",1184-78-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/956071fe-fffc-4e18-89b0-ff2865953b73/documents/e2f39e97-3c24-40cf-851b-b68c488806df_d9fdd2f5-ade8-4673-84ab-f02433317f2e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Trimethylamine, N-oxide",1184-78-7,Acute Oral toxicity: LD50 = 973 mg/kg bw (based on read-across to TMA) Acute Dermal toxicity: LD50 approximately 973 mg/kg bw (based on acute oral findings)   ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/956071fe-fffc-4e18-89b0-ff2865953b73/documents/4c665e6a-a8bd-41ed-97f8-557e7fbc27ff_d9fdd2f5-ade8-4673-84ab-f02433317f2e.html,,,,,, "Trimethylamine, N-oxide",1184-78-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/956071fe-fffc-4e18-89b0-ff2865953b73/documents/4c665e6a-a8bd-41ed-97f8-557e7fbc27ff_d9fdd2f5-ade8-4673-84ab-f02433317f2e.html,,oral,LD50,973 mg/kg bw,adverse effect observed, "Trimethylamine, N-oxide",1184-78-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/956071fe-fffc-4e18-89b0-ff2865953b73/documents/4c665e6a-a8bd-41ed-97f8-557e7fbc27ff_d9fdd2f5-ade8-4673-84ab-f02433317f2e.html,,dermal,LD50,ca.973 mg/kg bw,adverse effect observed, Trimethylammonium chloride,593-81-7," Oral: Amoore et al. (1978) repeated dose toxicity of trimethylamine hydrochloride in male Sprague-Dawley rats (90-day study, 0.04. 0.08, 0.16, 0.31, and 0.62 % trimethylamine hydrochloride in diet (corresponding to 0, 20, 40, 79, 150 and 310 mg/kg bw of trimethylamine). NOAEL of 0.16% diet TMA-HCl (= 130 mg/kg bw/day TMA-HCl (rounded from 128) = 79 mg/kg bw TMA) was established. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0cc1326-cbf3-42c1-96ff-30e37bcc570c/documents/2511ad5a-f5be-4c8c-bdd0-7eae087f3e33_eeff1cfa-1f43-4993-af9a-03523e300c20.html,,,,,, Trimethylammonium chloride,593-81-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0cc1326-cbf3-42c1-96ff-30e37bcc570c/documents/2511ad5a-f5be-4c8c-bdd0-7eae087f3e33_eeff1cfa-1f43-4993-af9a-03523e300c20.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,130 mg/kg bw/day,,rat Trimethylammonium chloride,593-81-7," - Acute oral toxicity: rats (HC/CFY (Remote Sprague-Dawley), TMA HCl as 58 % solution, single oral dose of 2000 mg/kg bw, gavage; LD50 > 2000 mg/kg bw (Key study 1,1984). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0cc1326-cbf3-42c1-96ff-30e37bcc570c/documents/IUC5-6172b630-0311-42cc-83a6-8735b18bc470_eeff1cfa-1f43-4993-af9a-03523e300c20.html,,,,,, Trimethylammonium chloride,593-81-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0cc1326-cbf3-42c1-96ff-30e37bcc570c/documents/IUC5-6172b630-0311-42cc-83a6-8735b18bc470_eeff1cfa-1f43-4993-af9a-03523e300c20.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Trimethylenediamine,109-76-2,"Trimethylenediamine is structurally very similar to ethylenediamine (difference: chain length / one CH2-group) or ethylenediammonium dichloride (applied doses of ammonium and chloride of no toxicological relevance). Thus, repeated oral dose studies' results generated by these substances are justified for read across to assess the repeated doses toxicity of trimethylenediamine.Results:- Oral route: For repeated oral toxicity a NOAEL of 27.9 mg/kg bw /day trimethylenediamine could be derived by read across from a respective study with ethylenediammonium dichloride.- Inhalation: An available NOAEC for EDA (analytical) could be calculated to be 177.6 mg/m³ air trimethylenediamine.- Dermal route: There were no treatment-related macroscopic or histopathologic findings in a lifetime dermal carcinogenicity study with EDA at the highest possible concentration in mice. Thus, respective results are also expected for trimethylenediamine (read across). A NOAEL of 10.2 mg/kg bw /day trimethylenediamine was derived due to the maximum tolerated dose (for local effects). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d3da272-7d1f-4be1-85b3-245865b68106/documents/IUC5-de7a9e23-cd24-4762-b86e-6117acb3e2c9_22b115e4-c7d5-4e3d-8265-89ba266c0255.html,,,,,, Trimethylenediamine,109-76-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d3da272-7d1f-4be1-85b3-245865b68106/documents/IUC5-de7a9e23-cd24-4762-b86e-6117acb3e2c9_22b115e4-c7d5-4e3d-8265-89ba266c0255.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,177.6 mg/m3,,rat Trimethylenediamine,109-76-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d3da272-7d1f-4be1-85b3-245865b68106/documents/IUC5-de7a9e23-cd24-4762-b86e-6117acb3e2c9_22b115e4-c7d5-4e3d-8265-89ba266c0255.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,27.9 mg/kg bw/day,,rat Trimethylenediamine,109-76-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7d3da272-7d1f-4be1-85b3-245865b68106/documents/IUC5-de7a9e23-cd24-4762-b86e-6117acb3e2c9_22b115e4-c7d5-4e3d-8265-89ba266c0255.html,Chronic toxicity – systemic effects,dermal,NOAEL,10.2 mg/kg bw/day,,mouse Trimethylenediamine,109-76-2,Oral: The acute oral LD50 was determined to be 311 mg/kg bw in rats.Dermal: The acute dermal LD50 was determined to be 178 mg/kg bw in rabbits.Inhalation: No mortality was detected when rats were exposed to a saturated atmosphere of the test substance for 8 hours. The concentration of the test material in saturated atmosphere was calculated to be 14165 mg/m3. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d3da272-7d1f-4be1-85b3-245865b68106/documents/IUC5-23578946-1304-4ccf-8f34-98cc5d319072_22b115e4-c7d5-4e3d-8265-89ba266c0255.html,,,,,, Trimethylenediamine,109-76-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d3da272-7d1f-4be1-85b3-245865b68106/documents/IUC5-23578946-1304-4ccf-8f34-98cc5d319072_22b115e4-c7d5-4e3d-8265-89ba266c0255.html,,oral,LD50,311 mg/kg bw,adverse effect observed, Trimethylenediamine,109-76-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d3da272-7d1f-4be1-85b3-245865b68106/documents/IUC5-23578946-1304-4ccf-8f34-98cc5d319072_22b115e4-c7d5-4e3d-8265-89ba266c0255.html,,dermal,LD50,178 mg/kg bw,adverse effect observed, Trimethylenediamine,109-76-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d3da272-7d1f-4be1-85b3-245865b68106/documents/IUC5-23578946-1304-4ccf-8f34-98cc5d319072_22b115e4-c7d5-4e3d-8265-89ba266c0255.html,,inhalation,LC50,"14,165 mg/m3",no adverse effect observed, Trimethylgallium,1445-79-0, No toxicological data are available: TMG reacts heavily with water and produces gasses that ignite spontaneously and for this reason oral administration is not feasible and dermal testing either (leading to burns). TMG is extremely corrosive and destructive to tissues and can cause severe burns and irreversible eye damage ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7954fd2c-82b7-4aef-aabe-c8bf5f61d9d5/documents/b36db011-0db4-486a-be45-d091c9575076_58db0f30-0e30-4166-9a5e-62419d6cce9c.html,,,,,, Trimethylindium,3385-78-2, No toxicological data are available. TMI reacts heavily with water and ignites when in contact with air and for this reason teesting is not feasible: TMI is extremely corrosive and destructive to tissue and may cause irreversible eye damage. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e26b7855-8792-4888-b4b6-1aaf126c3e18/documents/1da91660-3b83-44c6-b825-db108c2e0139_e77b39d2-931f-4da6-af9d-dbb1bd17bb3b.html,,,,,, Trimethylsilane,993-07-7," In a repeat-dose inhalation administration study (Mitsubishi, 2001), whole body exposure of trimethylsilane to rats for 28 consecutive days did not result in any findings attributable to treatment. The No-Observed-Adverse-Effect-Concentration (NOAEC) was therefore considered to be 4730 mg/m3 (4.73 mg/L), the highest concentration tested. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24c6a2aa-d524-46bc-93d2-7cff0d41448a/documents/dbd10738-dcdc-4f13-9f45-e31724650824_5ff467a7-05cb-4f94-bd7f-f033ad6f2d6e.html,,,,,, Trimethylsilane,993-07-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24c6a2aa-d524-46bc-93d2-7cff0d41448a/documents/dbd10738-dcdc-4f13-9f45-e31724650824_5ff467a7-05cb-4f94-bd7f-f033ad6f2d6e.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"4,730 mg/m3",,rat Trimethylsilane,993-07-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/24c6a2aa-d524-46bc-93d2-7cff0d41448a/documents/dbd10738-dcdc-4f13-9f45-e31724650824_5ff467a7-05cb-4f94-bd7f-f033ad6f2d6e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,"4,730 mg/m3",no adverse effect observed,rat Trimethylsilane,993-07-7,"Acute inhalation whole body exposure LC50 was greater than 5400 mg/m3 (DCC, 2001). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24c6a2aa-d524-46bc-93d2-7cff0d41448a/documents/f5e6bac7-6546-4946-9dfb-614f8a7b435c_5ff467a7-05cb-4f94-bd7f-f033ad6f2d6e.html,,,,,, Trimethylsilane,993-07-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/24c6a2aa-d524-46bc-93d2-7cff0d41448a/documents/f5e6bac7-6546-4946-9dfb-614f8a7b435c_5ff467a7-05cb-4f94-bd7f-f033ad6f2d6e.html,,inhalation,LC50,"5,400 mg/m3",no adverse effect observed, Trimethylsulfonium bromide,3084-53-5,"The acute oral LD50 in rats for Trimethylsulfonium bromide was estimated to be between 50 and 300 mg/kg b.w., and the cut-off value of LD50 was estimated to be 200 mg/kg b.w.. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/151d0f63-51bf-4146-ab44-759c6a526ab3/documents/0faae2ee-ebc5-4cee-9ac5-b9e065c527dc_a56a57bd-b727-4090-a991-d110b88e68fd.html,,,,,, Trimethylsulfonium bromide,3084-53-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/151d0f63-51bf-4146-ab44-759c6a526ab3/documents/0faae2ee-ebc5-4cee-9ac5-b9e065c527dc_a56a57bd-b727-4090-a991-d110b88e68fd.html,,oral,LD50,> 50 mg/kg bw,adverse effect observed, Trinickel dicitrate,6018-92-4,Oral:NOAEL = 7.02 mg/kg bw Trinickel dicitrateLOAEL = 21.1 mg/kg bw Trinickel dicitrateInhalation:NOAEC = 0.159 mg/m3 Trinickel dicitrateLOAEC = 0.368 mg/m3 Trinickel dicitrate ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bdcd120b-f0e6-4bd8-8a51-e51d85e89c1b/documents/IUC5-31010f7c-5c9f-4aec-96c7-16f349aa57a6_51fbf977-e2ab-4dd1-b029-8cff6ce1f00d.html,,,,,, Trinickel dicitrate,6018-92-4,Oral:LD50 cut-off = 500 mg/kg bw nickel hydrogencitrateDermal:LD50 > 2000 mg/kg bw nickel hydrogencitrate ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bdcd120b-f0e6-4bd8-8a51-e51d85e89c1b/documents/IUC5-1ac529cf-5bff-4587-973d-33eee84b9042_51fbf977-e2ab-4dd1-b029-8cff6ce1f00d.html,,,,,, Trinickel disulphide,12035-72-2," Value used for CSA: NOAEL (oral, systemic, rat): 2.2 mg Ni/kg bw/dayas nickel sulphate hexahydrate (read-across: Heim et al 2007) LOAEC (inhalation, local, rat): 0.11 mg Ni/m3 = 0.15 mg Ni3S2/m3 (Dunnick et al, 1995) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3916f11-a5eb-4897-9ba4-d754242a89c5/documents/aa1bbc3e-47c4-486e-87df-bb8ffa58cb15_39143fb6-e287-4c9e-8f1e-7286ea86e017.html,,,,,, Trinickel disulphide,12035-72-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b3916f11-a5eb-4897-9ba4-d754242a89c5/documents/aa1bbc3e-47c4-486e-87df-bb8ffa58cb15_39143fb6-e287-4c9e-8f1e-7286ea86e017.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,0.15 mg/m3,,rat Trinickel disulphide,12035-72-2," Value used for CSA: NOAEL (oral, systemic, animal): >11,000 mg Ni3S2/kg bw/day (or >8,000 mg Ni/kg bw/day) (EPSL, 2008) NOAEC (inhalation, systemic, animal): 0.206 mg Ni3S2/L air (or ~126 mg Ni/m³ air) (EPSL, 2010) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3916f11-a5eb-4897-9ba4-d754242a89c5/documents/2fe841c9-8cde-4c04-b094-05ecfca0fbb3_39143fb6-e287-4c9e-8f1e-7286ea86e017.html,,,,,, Trinickel disulphide,12035-72-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b3916f11-a5eb-4897-9ba4-d754242a89c5/documents/2fe841c9-8cde-4c04-b094-05ecfca0fbb3_39143fb6-e287-4c9e-8f1e-7286ea86e017.html,,inhalation,LC50,"1,140 mg/m3",, "Trinonyl benzene-1,2,4-tricarboxylate",35415-27-1,"No repeated dose toxicity data for the submission substance is available. However adequate and reliable data for a structural anologue (i.e. C8TM, for read-across justification please see read-across report in section 13) are reported here. In this Combined Repeated Dose Toxicity Study with Reproduction/Developmental Toxicity Screening (OECD 422, GLP conform, subacute exposure duration) a NOAEL of 125 mg/kg bw/day was identified. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7c72bb5-7ea9-428f-9bbd-0295a638b584/documents/IUC5-8ee8e000-4c86-4af6-b233-17efdc09b88a_35c2a581-caad-4adc-a7f8-e3fa104fb1d4.html,,,,,, "Trinonyl benzene-1,2,4-tricarboxylate",35415-27-1,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7c72bb5-7ea9-428f-9bbd-0295a638b584/documents/IUC5-8ee8e000-4c86-4af6-b233-17efdc09b88a_35c2a581-caad-4adc-a7f8-e3fa104fb1d4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,134.6 mg/kg bw/day,,rat "Trinonyl benzene-1,2,4-tricarboxylate",35415-27-1,"No acute toxicity data for the submission substance is available. However adequate and reliable data for structural anologues (i.e. C8TM and C8C10TM, for read-across justification please see read-across report in section 13) are reported here. Oral LD50 values of > 2000 and > 3000 mg/kg bw in rats have been reported for C8TM and C8C10TM, respectively (key study and supporting study). A dermal LD50 value for rats in a reliable study using C8C10TM as test material was > 2000 mg/kg bw . No data on acute toxicity after inhalation exposure is available. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7c72bb5-7ea9-428f-9bbd-0295a638b584/documents/IUC5-316b078e-53a0-4840-9f70-4acc880d4059_35c2a581-caad-4adc-a7f8-e3fa104fb1d4.html,,,,,, "Trinonyl benzene-1,2,4-tricarboxylate",35415-27-1,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7c72bb5-7ea9-428f-9bbd-0295a638b584/documents/IUC5-316b078e-53a0-4840-9f70-4acc880d4059_35c2a581-caad-4adc-a7f8-e3fa104fb1d4.html,,oral,discriminating dose,"2,150 mg/kg bw",no adverse effect observed, "Trioctyl benzene-1,2,4-tricarboxylate",89-04-3,Sub-chronic toxicity: NOAEL - 800 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91e5814b-6972-4fca-b85f-f7a0b1242953/documents/IUC5-8ec58ef8-f8a5-43cf-b22b-6d2ef28fec50_dd9df56b-fc68-45d8-9b53-d4b36aa393e7.html,,,,,, "Trioctyl benzene-1,2,4-tricarboxylate",89-04-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/91e5814b-6972-4fca-b85f-f7a0b1242953/documents/IUC5-8ec58ef8-f8a5-43cf-b22b-6d2ef28fec50_dd9df56b-fc68-45d8-9b53-d4b36aa393e7.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,800 mg/kg bw/day,,rat "Trioctyl benzene-1,2,4-tricarboxylate",89-04-3,- Acute toxicity:Oral: LD50: >2000 mg/kg in the ratDermal: LD50: > 2000 mg/kg in the rat ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91e5814b-6972-4fca-b85f-f7a0b1242953/documents/IUC5-f1e827b0-5acb-4519-90c6-15e6378de512_dd9df56b-fc68-45d8-9b53-d4b36aa393e7.html,,,,,, "Trioctyl benzene-1,2,4-tricarboxylate",89-04-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91e5814b-6972-4fca-b85f-f7a0b1242953/documents/IUC5-f1e827b0-5acb-4519-90c6-15e6378de512_dd9df56b-fc68-45d8-9b53-d4b36aa393e7.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Trioctyl benzene-1,2,4-tricarboxylate",89-04-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/91e5814b-6972-4fca-b85f-f7a0b1242953/documents/IUC5-f1e827b0-5acb-4519-90c6-15e6378de512_dd9df56b-fc68-45d8-9b53-d4b36aa393e7.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Trioctylphosphine oxide,78-50-2,Oral: The LOAEL of the test substance was 100 mg/kg bw/day.Dermal: The LOAEL of the test substance for systemic as well as local effects was 500 mg/kg bw/day. This dose level is equivalent to 2.8 mg/cm2 for dermal effects. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1822d332-fcf8-411c-9352-047dd2b782d8/documents/IUC5-ab713378-c785-426f-a568-4dfc07e38c31_c58bf36d-3880-4b0f-91e6-c7acf1758d54.html,,,,,, Trioctylphosphine oxide,78-50-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1822d332-fcf8-411c-9352-047dd2b782d8/documents/IUC5-ab713378-c785-426f-a568-4dfc07e38c31_c58bf36d-3880-4b0f-91e6-c7acf1758d54.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,100 mg/kg bw/day,,rat Trioctylphosphine oxide,78-50-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1822d332-fcf8-411c-9352-047dd2b782d8/documents/IUC5-ab713378-c785-426f-a568-4dfc07e38c31_c58bf36d-3880-4b0f-91e6-c7acf1758d54.html,Short-term repeated dose toxicity – systemic effects,dermal,LOAEL,500 mg/kg bw/day,,rat Trioctylphosphine oxide,78-50-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1822d332-fcf8-411c-9352-047dd2b782d8/documents/IUC5-ab713378-c785-426f-a568-4dfc07e38c31_c58bf36d-3880-4b0f-91e6-c7acf1758d54.html,Repeated dose toxicity – local effects,dermal,LOAEL,2.8 mg/cm2,adverse effect observed,rat Trioctylphosphine oxide,78-50-2,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The information requirements for this tonnage band is sufficiently met with the available data. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The information requirements for this tonnage band is sufficiently met with the available data. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1822d332-fcf8-411c-9352-047dd2b782d8/documents/IUC5-c0cf35fd-11dd-4693-82c1-ea58589422ec_c58bf36d-3880-4b0f-91e6-c7acf1758d54.html,,,,,, Trioctylphosphine oxide,78-50-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1822d332-fcf8-411c-9352-047dd2b782d8/documents/IUC5-c0cf35fd-11dd-4693-82c1-ea58589422ec_c58bf36d-3880-4b0f-91e6-c7acf1758d54.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Trioctylphosphine oxide,78-50-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1822d332-fcf8-411c-9352-047dd2b782d8/documents/IUC5-c0cf35fd-11dd-4693-82c1-ea58589422ec_c58bf36d-3880-4b0f-91e6-c7acf1758d54.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Triphenyl phosphite,101-02-0,"Oral: NOAEL = 15 mg/kg bw/d (m/f); rat, according to OECD TG 422, GLP, K2 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a88788fd-bd5e-4495-a773-3eb8a8389092/documents/63cebae7-abf2-4451-a547-734c27cd2425_1b6fa0a8-8e56-479b-a3da-d5778cb3d046.html,,,,,, Triphenyl phosphite,101-02-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a88788fd-bd5e-4495-a773-3eb8a8389092/documents/63cebae7-abf2-4451-a547-734c27cd2425_1b6fa0a8-8e56-479b-a3da-d5778cb3d046.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat Triphenyl phosphite,101-02-0,"Acute oral toxicity: LD50 = 1590/1630 mg/kg bw (m/f); rat, similar to OECD TG 401, non-GLP, K2 Acute inhalation toxicity: LC50 > 6.7 mg/L air (m/f); 1 h exposure, rat, similar to OECD TG 403, non-GLP, K2 Acute dermal toxicity: LD50 > 5000 mg/kg bw (m/f); rat, non-guidline, non-GLP, K2 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a88788fd-bd5e-4495-a773-3eb8a8389092/documents/e4d153d6-e501-4cd5-9c4b-5ab19bf8040a_1b6fa0a8-8e56-479b-a3da-d5778cb3d046.html,,,,,, Triphenyl phosphite,101-02-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a88788fd-bd5e-4495-a773-3eb8a8389092/documents/e4d153d6-e501-4cd5-9c4b-5ab19bf8040a_1b6fa0a8-8e56-479b-a3da-d5778cb3d046.html,,oral,LD50,"1,590 mg/kg bw",adverse effect observed, Triphenyl phosphite,101-02-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a88788fd-bd5e-4495-a773-3eb8a8389092/documents/e4d153d6-e501-4cd5-9c4b-5ab19bf8040a_1b6fa0a8-8e56-479b-a3da-d5778cb3d046.html,,dermal,LD50,"> 5,000 mg/kg bw",adverse effect observed, Triphenyl phosphite,101-02-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a88788fd-bd5e-4495-a773-3eb8a8389092/documents/e4d153d6-e501-4cd5-9c4b-5ab19bf8040a_1b6fa0a8-8e56-479b-a3da-d5778cb3d046.html,,inhalation,LC50,> 6.7 mg/L,no adverse effect observed, Triphenylphosphine oxide,791-28-6," In a study comparable to OECD Guideline 401, the LD50 of the test item was determined to be 685 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7e6b9f1-5ae8-4b18-89dc-6c5d3bd35014/documents/6d19639c-d824-4105-b0e3-780e70c5529c_80c453ab-6f64-4fe1-b902-6c637c6e15eb.html,,,,,, Triphenylphosphine oxide,791-28-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7e6b9f1-5ae8-4b18-89dc-6c5d3bd35014/documents/6d19639c-d824-4105-b0e3-780e70c5529c_80c453ab-6f64-4fe1-b902-6c637c6e15eb.html,,oral,LD50,685 mg/kg bw,adverse effect observed, Tripiperazine dicitrate,144-29-6," Repeated dose toxicity: oral The No Observed Adverse Effect Level (NOAEL) was considered to be 100 mg/kg body weight/day when albino Wistar male and female rat exposed to Piperazine citrate. Based on the results, it can be concluded that the chemical piperazine citrate is not likely to cause repeated dose toxicity by the oral route of exposure as per CLP classification criteria. Repeated dose toxicity: Inhalation The use of the chemical tripiperazine dicitrate is mostly as an anti-helminthic. Thus, repeated exposure by the inhalation route is highly unlikely and hence this end point was considered for waiver and the chemical is not likely to exhibit repeated dose toxicity by the inhaltion route. Repeated dose toxicity: Dermal The use of the chemical tripiperazine dicitrate is mostly as an anti-helminthic. Thus, repeated exposure by the dermal route is highly unlikely and hence this end point was considered for waiver and the chemical is not likely to exhibit repeated dose toxicity by the dermal route. Based on the available data and the applicable waivers, it can be concluded that the chemical tripiperazine dicitrate is not likely to cause repeated dose toxicity by the oral, inhalation or dermal route of exposure. Thus, the chemical is not likely to be considered for classification. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f34133e8-14ef-47fa-98b6-14ff4c462447/documents/IUC5-4e6e725f-c328-46cd-8ec2-53c4e10ee4c2_22aa0068-b23c-49a8-9e9b-5d01799a6553.html,,,,,, Tripiperazine dicitrate,144-29-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f34133e8-14ef-47fa-98b6-14ff4c462447/documents/IUC5-4e6e725f-c328-46cd-8ec2-53c4e10ee4c2_22aa0068-b23c-49a8-9e9b-5d01799a6553.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat Tripiperazine dicitrate,144-29-6," Acute toxicity: oral LD50 was considered to be 11,200 (12,678-9,825) mg/kg when rats were exposed to Piperazine citrate orally. Thus based on this value and as per CLP classification criteria  the substance does not classify as an acute oral toxicant. Acute toxicity: inhalation LC50 was considered to be > 5 mg/m3 and EC was considered to be 5 mg/m3 when 42-year-old woman exposed to piperazine citrate. Thus, according to the CLP classification criteria the test material does not classify as acutely toxic by the inhaltion route. Acute toxicity: dermal The study need not be conducted because the substance is classified as corrosive to the skin ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f34133e8-14ef-47fa-98b6-14ff4c462447/documents/IUC5-410303ba-8550-4cc0-a9e6-0686b7a951ed_22aa0068-b23c-49a8-9e9b-5d01799a6553.html,,,,,, Tripiperazine dicitrate,144-29-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f34133e8-14ef-47fa-98b6-14ff4c462447/documents/IUC5-410303ba-8550-4cc0-a9e6-0686b7a951ed_22aa0068-b23c-49a8-9e9b-5d01799a6553.html,,oral,LD50,"11,200 mg/kg bw",no adverse effect observed, Tripiperazine dicitrate,144-29-6,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f34133e8-14ef-47fa-98b6-14ff4c462447/documents/IUC5-410303ba-8550-4cc0-a9e6-0686b7a951ed_22aa0068-b23c-49a8-9e9b-5d01799a6553.html,,inhalation,LC50,5 mg/m3,no adverse effect observed, "Tripotassium [5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-4-sulpho-1-naphthyl)azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)",94246-75-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Reliability 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd3ef7b7-1654-4e32-a774-bdb6bbfc0d3f/documents/c78cf897-fb60-4b96-be8d-d3578e2a752c_c1f6efdf-7974-4754-93d8-7a324b1a83b1.html,,,,,, "Tripotassium [5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-4-sulpho-1-naphthyl)azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)",94246-75-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fd3ef7b7-1654-4e32-a774-bdb6bbfc0d3f/documents/c78cf897-fb60-4b96-be8d-d3578e2a752c_c1f6efdf-7974-4754-93d8-7a324b1a83b1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Tripotassium [5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-4-sulpho-1-naphthyl)azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)",94246-75-0," Oral route: The value of LD50 of the test substance, Ostazinová námoř. modř H-5R (Reactive Blue 234), for male rats is 7459 mg/kg of body weight. Inhalation route: data waiving In accordance with column 2 of REACH Annex VIII, Acute toxicity by inhalation (required in section 8.5.2) does not need to be conducted. The acute toxicity by other route (by dermal route) is available. Dermal route: The tested substance Ostazinová námořnická modř H-5R (Reactive Blue 234) is not absorbed in toxic amount, therefore is not classified as acute toxic by dermal route as value LD50 > 5000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd3ef7b7-1654-4e32-a774-bdb6bbfc0d3f/documents/924f0c64-202d-4ae6-8913-f8e6acd72b1f_c1f6efdf-7974-4754-93d8-7a324b1a83b1.html,,,,,, "Tripotassium [5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-4-sulpho-1-naphthyl)azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)",94246-75-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd3ef7b7-1654-4e32-a774-bdb6bbfc0d3f/documents/924f0c64-202d-4ae6-8913-f8e6acd72b1f_c1f6efdf-7974-4754-93d8-7a324b1a83b1.html,,oral,LD50,"7,459 mg/kg bw",adverse effect observed, "Tripotassium [5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-4-sulpho-1-naphthyl)azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)",94246-75-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd3ef7b7-1654-4e32-a774-bdb6bbfc0d3f/documents/924f0c64-202d-4ae6-8913-f8e6acd72b1f_c1f6efdf-7974-4754-93d8-7a324b1a83b1.html,,dermal,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Tripotassium hexacyanocobaltate,13963-58-1," In a combined repeated dose toxicity study with the reproduction/developmental toxicity screening rats were exposed for 43 (males) and 63 (females) days with tripotassium hexacyanocobaltate. No adverse effect were observed up to the highest dose tested. Thus, the NOAEL for male and female animals is considered 1000 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93281331-0402-4181-b8c5-32f5d3ae9417/documents/61810dea-39ed-47bc-b95f-e7f8b64ddc1a_bdcf8bbb-4c65-4444-ba8c-39df2edc1b5e.html,,,,,, Tripotassium hexacyanocobaltate,13963-58-1, Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 423; GLP; female rats) Acute inhalation toxicity: LC50 > 2114 mg/m³ air (analytical) (OECD 436; GLP) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/93281331-0402-4181-b8c5-32f5d3ae9417/documents/79af812a-0625-487b-8216-a654511a8f05_bdcf8bbb-4c65-4444-ba8c-39df2edc1b5e.html,,,,,, Tripotassium hexacyanoferrate,13746-66-2," In a long term (two year) repeated dose toxicity study with rats, the NOAEL of sodium ferrocyanide was determined to be ≥ 630 and ≥ 450 mg/kg bw/day for females and males, respectively, based on the absence of effects seen at the highest concentration. This result is read across to potassium ferricyanide. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/109e5e3d-ab58-4123-b645-39b3ae633af0/documents/c54dd9ca-3d80-4a61-8e4a-24f201d7d542_f5848feb-301b-4662-ad5c-c71d560c05df.html,,,,,, Tripotassium hexacyanoferrate,13746-66-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/109e5e3d-ab58-4123-b645-39b3ae633af0/documents/c54dd9ca-3d80-4a61-8e4a-24f201d7d542_f5848feb-301b-4662-ad5c-c71d560c05df.html,Chronic toxicity – systemic effects,oral,NOAEL,450 mg/kg bw/day,,rat Tripotassium hexacyanoferrate,13746-66-2," An acute oral and an acute dermal toxicity study are available for substance analogue potassium ferrocyanide. Testing was performed similar to or according to the respective OECD test guidelines. Both the oral and the dermal LD50 values exceed 2000 mg/kg bw. These results are read across to potassium ferricyanide, the read across hypothesis is attached in IUCLID Section 13. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/109e5e3d-ab58-4123-b645-39b3ae633af0/documents/d65a2729-08d7-48ed-a499-2e129abc9c8b_f5848feb-301b-4662-ad5c-c71d560c05df.html,,,,,, Tripotassium hexacyanoferrate,13746-66-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/109e5e3d-ab58-4123-b645-39b3ae633af0/documents/d65a2729-08d7-48ed-a499-2e129abc9c8b_f5848feb-301b-4662-ad5c-c71d560c05df.html,,oral,LD50,"5,110 mg/kg bw",no adverse effect observed, Tripotassium hexacyanoferrate,13746-66-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/109e5e3d-ab58-4123-b645-39b3ae633af0/documents/d65a2729-08d7-48ed-a499-2e129abc9c8b_f5848feb-301b-4662-ad5c-c71d560c05df.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tripotassium propylsilanetriolate,93857-00-2," There are no repeated dose toxicity data on tripotassium propylsilanetriolate and testing is not technically feasible due to the corrosive nature of the test substance, so good quality data for the surrogate substance trimethoxy(methyl)silane (CAS 1185-55-3) have been used to assess the systemic toxicity of tripotassium propylsilanetriolate. The key studies for this endpoint are an oral OECD Guideline 422 (Combined Repeated Dose Toxicity Study with the Reproduction / Developmental Toxicity Screening Test) study and an inhalation OECD Guideline 413 (90-day sub chronic study with 28-day recovery period) study. The studies were conducted according to an appropriate OECD test guideline, and in compliance with GLP (reliability score 1). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba721d62-84a0-4266-bfb4-7ab2f270debd/documents/bc9056b1-ee26-43ae-b01f-5ff1fbb18a54_3bc98c1b-c443-4ef2-9113-85151cdbeb7f.html,,,,,, Tripotassium propylsilanetriolate,93857-00-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba721d62-84a0-4266-bfb4-7ab2f270debd/documents/bc9056b1-ee26-43ae-b01f-5ff1fbb18a54_3bc98c1b-c443-4ef2-9113-85151cdbeb7f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat Tripotassium propylsilanetriolate,93857-00-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba721d62-84a0-4266-bfb4-7ab2f270debd/documents/bc9056b1-ee26-43ae-b01f-5ff1fbb18a54_3bc98c1b-c443-4ef2-9113-85151cdbeb7f.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,557 mg/m3,,rat Tripotassium propylsilanetriolate,93857-00-2," No acute toxicity data are available for the registered substance and the substance is classified as corrosive to skin, therefore new testing is not scientifically necessary. Acute oral and inhalation tests on the structurally analogous substances trimethoxy(propyl)silane (CAS 1067-25-0) and trimethoxy(methyl)silane (CAS 1185 -55 -3) are included to support the read-across approach proposed to fill data gaps for higher tier endpoints. The key study for acute oral toxicity reports an LD50 value of >5000 mg/kg bw determined in a reliable study conducted according to OECD TG 401 (ASTA Pharma, 1988). The key study for acute inhalation toxicity, reports an LC50 value of >22200 mg/m³, determined in a reliable study conducted according to OECD TG 403 (TNO 1990).   ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba721d62-84a0-4266-bfb4-7ab2f270debd/documents/72e0ce11-0405-4059-a57f-8f2ff74245fd_3bc98c1b-c443-4ef2-9113-85151cdbeb7f.html,,,,,, Tripotassium propylsilanetriolate,93857-00-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba721d62-84a0-4266-bfb4-7ab2f270debd/documents/72e0ce11-0405-4059-a57f-8f2ff74245fd_3bc98c1b-c443-4ef2-9113-85151cdbeb7f.html,,oral,LD50,"5,170 mg/kg bw",no adverse effect observed, Tripotassium propylsilanetriolate,93857-00-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba721d62-84a0-4266-bfb4-7ab2f270debd/documents/72e0ce11-0405-4059-a57f-8f2ff74245fd_3bc98c1b-c443-4ef2-9113-85151cdbeb7f.html,,inhalation,LC50,"22,200 mg/m3",no adverse effect observed, Tripropylamine,102-69-2,Oral: study ongoing; rat; according to OECD 408/422; GLP; K1 Inhalation: no study available Dermal: no study available ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72dcf028-b4c4-4dc8-81cf-76aa9a10054f/documents/1cc5a685-6d15-4782-b9da-f1d2019a9a50_a8627b5a-d23f-4b71-b21c-0ae9ce1fd6c2.html,,,,,, Tripropylamine,102-69-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/72dcf028-b4c4-4dc8-81cf-76aa9a10054f/documents/1cc5a685-6d15-4782-b9da-f1d2019a9a50_a8627b5a-d23f-4b71-b21c-0ae9ce1fd6c2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat Tripropylamine,102-69-2,Oral: LD50 > 200 < 2000 mg/kg bw; rat; similar to OECD TG 401; non-GLP; K2 Inhalation: LC50(4h) = 1.125 mg/L; rat; non-guideline; pre-GLP; K2 Dermal: LD50 = 430 mg/kg bw; rabbit; non-guideline; pre-GLP; K2 ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72dcf028-b4c4-4dc8-81cf-76aa9a10054f/documents/4ad90762-d59f-4087-8391-a46d4ea362b0_a8627b5a-d23f-4b71-b21c-0ae9ce1fd6c2.html,,,,,, Tripropylamine,102-69-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72dcf028-b4c4-4dc8-81cf-76aa9a10054f/documents/4ad90762-d59f-4087-8391-a46d4ea362b0_a8627b5a-d23f-4b71-b21c-0ae9ce1fd6c2.html,,oral,LD50,200 mg/kg bw,adverse effect observed, Tripropylamine,102-69-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72dcf028-b4c4-4dc8-81cf-76aa9a10054f/documents/4ad90762-d59f-4087-8391-a46d4ea362b0_a8627b5a-d23f-4b71-b21c-0ae9ce1fd6c2.html,,dermal,LD50,430 mg/kg bw,adverse effect observed, Tripropylamine,102-69-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/72dcf028-b4c4-4dc8-81cf-76aa9a10054f/documents/4ad90762-d59f-4087-8391-a46d4ea362b0_a8627b5a-d23f-4b71-b21c-0ae9ce1fd6c2.html,,inhalation,LC50,1.125 mg/L,adverse effect observed, "Tris(2,4-ditert-butylphenyl) phosphite",31570-04-4," In a chronic dietary study in rats, the highest dose of 2000 ppm (ca 58 - 147 mg/kg bw) caused no indication of toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53c3c32c-9345-4479-9f11-785fc1dc71a9/documents/6eb34ed9-c9bd-47ef-b7fc-0594d473162c_b9209e1d-92e9-48c2-9a13-6458153efafc.html,,,,,, "Tris(2,4-ditert-butylphenyl) phosphite",31570-04-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/53c3c32c-9345-4479-9f11-785fc1dc71a9/documents/6eb34ed9-c9bd-47ef-b7fc-0594d473162c_b9209e1d-92e9-48c2-9a13-6458153efafc.html,Chronic toxicity – systemic effects,oral,NOAEL,58 mg/kg bw/day,,rat "Tris(2,4-ditert-butylphenyl) phosphite",31570-04-4," LD50 oral (rat, mouse, hamster): >6000 mg/kg bw (m+f) LD50 dermal (rat): >2000 mg/kg bw (m+f) LD50 intraperitoneal (rat): >2000 mg/kg bw (m+f) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53c3c32c-9345-4479-9f11-785fc1dc71a9/documents/e6394e35-a73f-43d4-b00a-c0158e101da6_b9209e1d-92e9-48c2-9a13-6458153efafc.html,,,,,, "Tris(2,4-ditert-butylphenyl) phosphite",31570-04-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53c3c32c-9345-4479-9f11-785fc1dc71a9/documents/e6394e35-a73f-43d4-b00a-c0158e101da6_b9209e1d-92e9-48c2-9a13-6458153efafc.html,,oral,LD50,"6,000 mg/kg bw",no adverse effect observed, "Tris(2,4-ditert-butylphenyl) phosphite",31570-04-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53c3c32c-9345-4479-9f11-785fc1dc71a9/documents/e6394e35-a73f-43d4-b00a-c0158e101da6_b9209e1d-92e9-48c2-9a13-6458153efafc.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tris(2-ethylhexyl) phosphate,78-42-2," Conclusion: The test item turned out to be of low toxicity after repeated applications to mice and rats. Slight, isolated and not consistent deviations were observed on hematology and blood chemistry (males only) in a sub-acute toxicity study in rats similar to OECD TG 407 (including a recovery group). These effects should not be regarded as toxicologically significant, due to the fact that they were only in some cases statistically significant (due to high variability of the respective parameter) and were observed just in one without confirmation by the other sex. Additionally, no effects on organs were observed [including hematopoietic organs (bone marrow, spleen, lymph node, thymus and heart)] in the same study as well as in sub chronic and comprehensive chronic studies in rats and mice at similar and higher doses. The only effects observed in sub-chronic and chronic studies were local inflammation in the gastric mucosa in mice (considered not to be relevant for systemic toxicity) and slight-moderate depression in body weight gain in rats and mice. Based on the sub-chronic and chronic studies in rats a NOAEL of 1000 mg/kg bw/day was selected as starting point for the repeated dose systemic toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54828081-2899-475a-8ef3-766ae9926879/documents/IUC5-dfc837f2-add7-4d17-a238-da374ccc5ce2_f85aef79-807f-4933-8eb1-2b6b6d1979f5.html,,,,,, Tris(2-ethylhexyl) phosphate,78-42-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/54828081-2899-475a-8ef3-766ae9926879/documents/IUC5-dfc837f2-add7-4d17-a238-da374ccc5ce2_f85aef79-807f-4933-8eb1-2b6b6d1979f5.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tris(2-ethylhexyl) phosphate,78-42-2," Conclusion: Overall the test substance was found to be of low acute toxicity in oral, inhalation and dermal experiments. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54828081-2899-475a-8ef3-766ae9926879/documents/IUC5-c9e775fd-e9c9-4d31-a44a-af7836abe3fe_f85aef79-807f-4933-8eb1-2b6b6d1979f5.html,,,,,, Tris(2-ethylhexyl) phosphate,78-42-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54828081-2899-475a-8ef3-766ae9926879/documents/IUC5-c9e775fd-e9c9-4d31-a44a-af7836abe3fe_f85aef79-807f-4933-8eb1-2b6b6d1979f5.html,,oral,LD50,">=9,290 mg/kg bw",no adverse effect observed, Tris(2-ethylhexyl) phosphate,78-42-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/54828081-2899-475a-8ef3-766ae9926879/documents/IUC5-c9e775fd-e9c9-4d31-a44a-af7836abe3fe_f85aef79-807f-4933-8eb1-2b6b6d1979f5.html,,inhalation,LC50,> 447 mg/m3,no adverse effect observed, Tris(2-hydroxyethyl)ammonium acetate,14806-72-5,This information is based on a study on a 28 day oral toxicity study using the read-across substance RA2. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62d47df7-7dca-4f4f-a617-919f1412fa66/documents/IUC5-5ccc3a99-b342-4061-ab8c-8cd3daceb01a_613cade5-ece6-4c44-af01-566d6a02c485.html,,,,,, Tris(2-hydroxyethyl)ammonium acetate,14806-72-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/62d47df7-7dca-4f4f-a617-919f1412fa66/documents/IUC5-5ccc3a99-b342-4061-ab8c-8cd3daceb01a_613cade5-ece6-4c44-af01-566d6a02c485.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tris(2-hydroxyethyl)ammonium acetate,14806-72-5,"This summary is based on the effect level of Read Across substance 1 (RA1) in the acute oral toxicity study, and Read Across substance 2 (RA2) in the acute dermal toxicity study. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62d47df7-7dca-4f4f-a617-919f1412fa66/documents/IUC5-630b0923-53b8-4e08-b443-8d8e7a635003_613cade5-ece6-4c44-af01-566d6a02c485.html,,,,,, Tris(2-hydroxyethyl)ammonium acetate,14806-72-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62d47df7-7dca-4f4f-a617-919f1412fa66/documents/IUC5-630b0923-53b8-4e08-b443-8d8e7a635003_613cade5-ece6-4c44-af01-566d6a02c485.html,,oral,LD50,"2,000 mg/kg bw",, Tris(2-hydroxyethyl)ammonium acetate,14806-72-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/62d47df7-7dca-4f4f-a617-919f1412fa66/documents/IUC5-630b0923-53b8-4e08-b443-8d8e7a635003_613cade5-ece6-4c44-af01-566d6a02c485.html,,dermal,LD50,"2,000 mg/kg bw",, Tris(2-hydroxyethyl)methylammonium methyl sulphate,29463-06-7,"OECD 408 (subchronic toxicity): NOEL of 406.4 and 495.5 mg/kg bw/d for male and female rats, respectively. (Colgate-Palmolive, 1991) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fb0890fc-63e3-4df4-947e-89b2ba6a31a5/documents/a28093ae-0984-47a1-a6d7-b28b5f8caa9b_0e3fb345-c78c-4202-a533-6f624eca149b.html,,,,,, Tris(2-hydroxyethyl)methylammonium methyl sulphate,29463-06-7,"LD50 oral > 6400 mg/kg bw, no mortality observed (BASF AG, 1971)LD50 dermal > 2000 mg/kg bw, no mortality observed (BASF SE, 2014) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb0890fc-63e3-4df4-947e-89b2ba6a31a5/documents/5901c547-114a-4865-bd7d-2c96963bc799_0e3fb345-c78c-4202-a533-6f624eca149b.html,,,,,, Tris(2-hydroxyethyl)methylammonium methyl sulphate,29463-06-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb0890fc-63e3-4df4-947e-89b2ba6a31a5/documents/5901c547-114a-4865-bd7d-2c96963bc799_0e3fb345-c78c-4202-a533-6f624eca149b.html,,oral,discriminating dose,"6,400 mg/kg bw",no adverse effect observed, Tris(2-hydroxyethyl)methylammonium methyl sulphate,29463-06-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fb0890fc-63e3-4df4-947e-89b2ba6a31a5/documents/5901c547-114a-4865-bd7d-2c96963bc799_0e3fb345-c78c-4202-a533-6f624eca149b.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Tris(ethyl acetoacetato-O1',O3)aluminium",15306-17-9," NOAEL Tris(ethyl acetoacetato-O1',O3)aluminium(repeated oral toxicity rat 28 days) = 798 mg/kg bw/day ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ed52f5c-d968-4681-8d70-fc39877260f7/documents/19429b2e-5de1-4c60-8717-333788052e63_196571f3-d6fb-4a83-9ac0-9108030df35e.html,,,,,, "Tris(ethyl acetoacetato-O1',O3)aluminium",15306-17-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3ed52f5c-d968-4681-8d70-fc39877260f7/documents/19429b2e-5de1-4c60-8717-333788052e63_196571f3-d6fb-4a83-9ac0-9108030df35e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,798 mg/kg bw/day,,rat "Tris(ethyl acetoacetato-O1',O3)aluminium",15306-17-9, LD50 oral rat > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3ed52f5c-d968-4681-8d70-fc39877260f7/documents/023ef665-1a4d-4f83-aa9c-e4240afd06d4_196571f3-d6fb-4a83-9ac0-9108030df35e.html,,,,,, Tris(isopropenyloxy)vinylsilane,15332-99-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/171a2e70-57a2-4916-8114-542df6fa8af5/documents/IUC5-4880882a-1c84-4463-a7f9-b525ad1693ec_d9d1bea4-edfe-46cf-bef0-0963f972c3da.html,,oral,LD50,"18,000 mg/kg bw",no adverse effect observed, Tris(isopropenyloxy)vinylsilane,15332-99-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/171a2e70-57a2-4916-8114-542df6fa8af5/documents/IUC5-4880882a-1c84-4463-a7f9-b525ad1693ec_d9d1bea4-edfe-46cf-bef0-0963f972c3da.html,,inhalation,LC50,"4,310 mg/m3",no adverse effect observed, Tris(methylphenyl) phosphite,25586-42-9,The LD50 (oral route) retained for classification is not equal to 300 mg/kg/day but higher than 300 mg/kg/day (between 300 and 2000 mg/kg/day. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/643b0346-0e32-439d-bd83-1ed99b8420f7/documents/IUC5-f8d3f8e9-a8bd-4975-b0fa-9479131f3a3c_48be4c3a-b30a-4c77-834c-fb33eefc9546.html,,,,,, Tris(methylphenyl) phosphite,25586-42-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/643b0346-0e32-439d-bd83-1ed99b8420f7/documents/IUC5-f8d3f8e9-a8bd-4975-b0fa-9479131f3a3c_48be4c3a-b30a-4c77-834c-fb33eefc9546.html,,oral,LD50,300 mg/kg bw,, "Tris(oxiranylmethyl) benzene-1,2,4-tricarboxylate",7237-83-4,"A 28-day repeated dose oral toxicity study in rats conducted according to OECD test guideline 407 demonstrated a NOAEL of 150 mg/kg body weight/day for systemic toxicity of tris(oxiranylmethyl)benzene-1,2,4-tricarboxylate. A repeated dose 90-day oral toxicity study is proposed by the lead registrant, subject to approval of the Test Plan by ECHA. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f51ee59-5e32-4327-9950-7e10748a2865/documents/IUC5-62b556e7-6058-477a-b3d2-2cde46bb0897_0d9ce87d-24bc-4f08-bf4b-a55cfd0b40f5.html,,,,,, "Tris(oxiranylmethyl) benzene-1,2,4-tricarboxylate",7237-83-4,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/8f51ee59-5e32-4327-9950-7e10748a2865/documents/IUC5-62b556e7-6058-477a-b3d2-2cde46bb0897_0d9ce87d-24bc-4f08-bf4b-a55cfd0b40f5.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "Tris(oxiranylmethyl) benzene-1,2,4-tricarboxylate",7237-83-4,"An acute oral toxicity study was performed in five male and five female animals. The animals were treated with tris(oxiranylmethyl)benzene-1,2,4-tricarboxylate at 2000 mg/kg. The oral LD50 in rats was found to be greater than 2000 mg/kg.An acute dermal toxicity study was performed in five male and five female animals. The animals were treated with tris(oxiranylmethyl)benzene-1,2,4-tricarboxylate at 2000 mg/kg. The dermal LD50 in rats was found to be greater than 2000 mg/kg. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f51ee59-5e32-4327-9950-7e10748a2865/documents/IUC5-08938170-8e90-4acf-93f1-d11a18c6c1a8_0d9ce87d-24bc-4f08-bf4b-a55cfd0b40f5.html,,,,,, "Tris(oxiranylmethyl) benzene-1,2,4-tricarboxylate",7237-83-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f51ee59-5e32-4327-9950-7e10748a2865/documents/IUC5-08938170-8e90-4acf-93f1-d11a18c6c1a8_0d9ce87d-24bc-4f08-bf4b-a55cfd0b40f5.html,,oral,LD50,"2,000 mg/kg bw",, "Tris(oxiranylmethyl) benzene-1,2,4-tricarboxylate",7237-83-4,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f51ee59-5e32-4327-9950-7e10748a2865/documents/IUC5-08938170-8e90-4acf-93f1-d11a18c6c1a8_0d9ce87d-24bc-4f08-bf4b-a55cfd0b40f5.html,,dermal,LD50,"2,000 mg/kg bw",, "tris(pentane-2,4-dionato)iron(III)",14024-18-1," Toxicité avec doses répétées par voie orale:   Compte-tenu de sa solubilité dans l’eau d’environ 2.0 g/L, la substance à enregistrer: acétylacétonate de fer (substance cible) se dissocie presque entièrement en espèces chargées en milieu aqueux (les deux substances sources): les anions organiques d’acétylacétone (aussi appelé 2,4-pentanedione) et les cations métalliques de fer trivalents (Fe3+). Le tractus gastro-intestinal des mammifères (rats, souris, lapins) peut être considéré comme un milieu aqueux (salives, suc digestifs etc.) et la méthode d’évaluation de la toxicité avec doses répétées par voie orale de la substance à enregistrer peut donc être basée sur une approche par références croisées (« Read across »), en considérant la toxicité avec doses répétées par voie orale de la partie organique et de la partie inorganique séparément dans un premier temps, et en conjonction par la suite pour l’évaluation finale.  Pour l’évaluation de la toxicité avec doses répétées par voie orale de la substance à enregistrer, la toxicité de sa partie organique (2,4-pentanedione) et de sa partie inorganique (fer trivalent : Fe3+) ont donc été prises en compte en considérant la substance à enregistrer comme un mélange composé de sa partie organique (2,4 pentanedione) et de sa partie inorganique (le fer). Etant donné que des données de toxicité aigüe par voie orale existent pour les 2 composants (2,4-pentanedione et fer) de ce mélange (acétylacétonate de fer) et en vertu du règlement (CE) numéro 1272/2008 du parlement européen et du conseil relatif à la classification, à l'étiquetage et à l'emballage des substances et des mélanges (CLP regulation), section3.1.3.6.1., une approche similaire à celle de la formule d’additivité peut donc être utilisée. L’estimation de la toxicité avec doses répétées par voie orale peut se faite de la même manière que pour la toxicité aigüe (ETA) du mélange (acétylacétonate de fer) est donc calculée à partir des valeurs d'ETA (ici remplacé par les DNSEO ou NOAEL) des composants à prendre en compte (2,4-pentanedione et fer), à l'aide de la formule suivante: 100/ATEmix= ∑nCi/ATEi dans laquelle: ATEmix= estimation de la toxicité aiguë du mélange Ci= concentration du composant i ( % m/m ou % v/v) i = composant individuel de 1 à n n = nombre de composants ETAi= estimation de la toxicité aiguë du composant i.   La concentration de chacun des 2 composants dans le mélange a été calculée sur la base de leur contribution en masse. Pour ce faire, les masses moléculaires (MM) de l’acétylacétone (100.12 g/mole), du fer (55.845 g/mole) et de l’acétylacétonate de fer (353.17 g/mole) ont été utilisées. Ainsi, compte-tenu de la structure moléculaire de l’acétylacétone (C5H8O2) et de celle de l’acétylacétonate de fer (Fe(C5H7O2)3), la concentration de chacun des 2 composants du mélange ont été calculée de la manière suivante : -         Concentration de l’acétylacétone dans le mélange : ((100.12 x 3)/353.17)*100 = 85.05% -         Concentration du fer dans le mélange : (55.845/353.17)*100 = 15.81%   Les données existantes sur la toxicité avec doses répétées par voie orale de l’acétylacétone (2,4-pentanedione) indiquent une DSENO (NOAEL) de 100 mg/kg de poids corporel/jour (OECD, 2001). En ce qui concerne les données de toxicité avec doses répétées par voie orale du fer trivalent (Fe3+), une seule étude fiable existe, les essais ayant été effectués avec des rats femelles et mâles ayant ingérés du chlorure ferrique hexahydraté (FeCl3). La DSENO (NOAEL) retenue pour l’évaluation est celle obtenue avec les mâles et elle est de 95 mg de Fer/kg de poids corporel/jour (Sato et al., 1992).. En appliquant la formule d’additivité décrite ci-dessus, cette approche par références croisées permet donc de calculer une dose sans effet nocif observé de 988 mg/kg de poids corporel/jour envers les rats pour l'acétylacétonate de fer. D'autre part, certains effets systémiques ont été mis en évidence après exposition par voie orale pour les 2 parties de la substance à enregistrer (effets sur le thymus, foie, poumons, reins, vessies et ganglions lymphatiques pour la 2,4-pentanedione et quelques effets hématologiques et d’ordre histopathologiques pour le Fer) mais ces effets ne sont pas apparus suffisamment avérés/sévères pour mener au classement de la substance à enregistrer: acétylacétonate de Fer. .   Toxicité avec doses répétées par inhalation: Compte-tenu de sa solubilité dans l’eau d’environ 2.0 g/L, la substance à enregistrer: acétylacétonate de fer (substance cible) se dissocie presque entièrement en espèces chargées (les deux substances sources): les anions organiques d’acétylacétone (aussi appelé 2,4-pentanedione) et les cations métalliques de fer trivalents (Fe3+). La méthode d’évaluation de la toxicité avec doses répétées par inhalation de la substance à enregistrer envers les poissons peut donc être basée sur une approche par références croisées (« Read across »), en considérant la toxicité avec doses répétées par inhalation de la partie organique et de la partie inorganique séparément dans un premier temps, et en conjonction par la suite pour l’évaluation finale.  Les données existantes sur la toxicité avec doses répétées par inhalation des deux parties de la substance à enregistrer indiquent une LOEAC de 2711 mg/m3 chez des lapins exposés à de la 2,4-pentanedione par inhalation pendant une période de 14 semaines (Dodd et al., 1986) et une LOEAC de 1668 mg/m3 chez des rats exposés à de la 2,4-pentanedione par inhalation pendant 9 jours (Dodd et al., 1986). En ce qui concerne le Fer, une LOEAC de 1.4 mg/m3 a été établie chez des rats exposés à du Chlorure ferrique (FeCl3) pendant une période de 2 mois (Johansson et al., 1992). La toxicité de la 2,4-pentanedione apparait donc négligeable comparée à celle du Fer et pour l’évaluation de la toxicité avec doses répétées par inhalation de la substance à enregistrer, seule la toxicité de sa partie inorganique (le Fer) est donc considérée. Les indicateurs toxicologiques (LOEAC) de la substance à enregistrer ont ensuite été recalculés en utilisant un facteur de conversion qui tient compte de la contribution en masse de la partie inorganique de la substance à enregistrer par rapport à sa masse totale. Le calcul de ce facteur de conversion se base sur la comparaison de la masse moléculaire (MM) de la 2,4-pentanedione et du Fer. L’acétylacétonate de fer (Fe(C5H7O2)3) a une MM de 353.17 g/mole et le Fer a une MM de 55.85 g/mole. Compte-tenu de la masse moléculaire des 2 substances, le facteur de conversion a été calculé de la manière suivante : 353.17/55.85 = 6.32. Il a donc ensuite été appliqué aux données toxicologiques existantes pour le Fer pour dériver les données toxicologiques de la substance à enregistrer. Cela permet donc de calculer une LOEAC de 8.85 mg/m3 en ce qui concerne la toxicité avec doses répétées par inhalation pour la substance à enregistrer. D'autre part, certains effets systémiques ont été mis en évidence après exposition par inhalation pour les 2 parties de la substance à enregistrer (irritation de la muqueuse nasale, changement dans l’hématologie, dans la chimie clinique et urinaire, effets sur certains organes comme le cerveau et le thymus pour la 2,4-pentanedione et effets d’ordre immunologique pour le Fer) mais ces effets ne sont pas apparus suffisamment avérés pour mener au classement de la substance à enregistrer: acétylacétonate de Fer.   Toxicité avec doses répétées par voie cutanée: Compte-tenu de sa solubilité dans l’eau d’environ 2.0 g/L, la substance à enregistrer: acétylacétonate de fer (substance cible) se dissocie presque entièrement en espèces chargées (les deux substances sources): les anions organiques d’acétylacétone (aussi appelé 2,4-pentanedione) et les cations métalliques de fer trivalents (Fe3+). La méthode d’évaluation de la toxicité avec doses répétées par voie cutanée de la substance à enregistrer envers les poissons peut donc être basée sur une approche par références croisées (« Read across »), en considérant la toxicité avec doses répétées par voie cutanée de la partie organique et de la partie inorganique séparément dans un premier temps, et en conjonction par la suite pour l’évaluation finale.  Les données existantes sur la toxicité avec doses répétées par voie cutanée des deux parties de la substance à enregistrer indiquent une NOEAL de 244 mg/kg de poids corporel/jour chez des lapins exposés par occlusion pendant 9 jours (Ballantyne 2001) alors qu’aucune données ne sont disponibles en ce qui concerne la toxicité avec doses répétées par voie cutanée pour le Fer. Pour l’évaluation de la toxicité avec doses répétées par voie cutanée de la substance à enregistrer, seule la toxicité de sa partie organique (2,4-pentanedione) a donc été prise en compte. Les indicateurs toxicologiques (NOEAL) de la substance à enregistrer ont ensuite été recalculés en utilisant un facteur de conversion qui tient compte de la contribution en masse de la partie organique de la substance à enregistrer par rapport à sa masse totale. Le calcul de ce facteur de conversion se base sur la comparaison de la masse moléculaire (MM) de la 2,4-pentanedione et de l’acétylacétonate de fer et prend en compte la structure moléculaire des 2 molécules. La 2,4-pentanedione (C5H8O2) a une MM de 100.12 g/mole et l’acétylacétonate de fer (Fe(C5H7O2)3) a une MM de 353.17 g/mole. Compte-tenu de la structure moléculaire des 2 substances, le facteur de conversion a été calculé de la manière suivante : 353.17/(100.12 x 3) = 1.18. Il a donc ensuite été appliqué aux données toxicologiques existantes pour la 2,4-pentanedione pour dériver les données écotoxicologiques de la substance à enregistrer. Ceci permet donc de calculer une NOEAL de 287 mg/kg de poids corporel/jour en ce qui concerne la toxicité avec doses répétées par voie cutanée de la substance à enregistrer : l’acétylacétonate de Fer. D'autre part, certains effets systémiques ont été mis en évidence après exposition par inhalation pour la partie organique de la substance à enregistrer (effets irritants, hémorragie, dégénération neuronale dans la région du cerveau, et effets/hémorragie dans la rate, le thymus et les ganglions lymphatiques) mais ces effets ne sont pas apparus suffisamment avérés pour mener au classement de la substance à enregistrer: acétylacétonate de Fer.     Références : Ballantyne B, Cawley TJ (2001) Toxicology update: 2,4-Pentanedione. Journal of Applied Toxicology 21, 165–171. Dodd DE, Garman RH, Pritts IM, Troup CM, Snellings WM, Ballantyne B (1986) 2,4- Pentanedione: 9-Day and 14-Week Vapor Inhalation Studies in Fischer-344 Rats. Fundamental and Applied Toxicology 7: 329-339. Johansson A, Curstedt T, Rasool O, Jarstrand C, Camner P (1992) Macrophage Reaction in Rabbit Lung following Inhalation of Iron Chloride. Environmental Research 58(1-2):66-79. OECD Organisation for Economic Co-operation and Development (2001). 2,4-Pentanedione. CAS N°: 123-54-6. SIDS Initial Assessment Report for SIAM 13 (Paris, France, in June) United Nations Environment Programme (UNEP) Publications, Nairobi, Kenya.82 p. Sato M, Furukawa F, Toyoda K, Mitsumori K, Nishikawa A, Takahashi M (1992) Lack of Carcinogenicity of Ferric Chloride in F344 Rats. Food and Chemical Toxicology 30(10):837-42. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ee6de76-ec68-4f86-a697-d7b961e8b34d/documents/dd5dda7a-7e11-429b-874f-8d50e2041895_40c7ddc5-997e-4b32-aea8-8bc39c98b316.html,,,,,, "tris(pentane-2,4-dionato)iron(III)",14024-18-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ee6de76-ec68-4f86-a697-d7b961e8b34d/documents/dd5dda7a-7e11-429b-874f-8d50e2041895_40c7ddc5-997e-4b32-aea8-8bc39c98b316.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,98 mg/kg bw/day,,rat "tris(pentane-2,4-dionato)iron(III)",14024-18-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ee6de76-ec68-4f86-a697-d7b961e8b34d/documents/dd5dda7a-7e11-429b-874f-8d50e2041895_40c7ddc5-997e-4b32-aea8-8bc39c98b316.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,287 mg/kg bw/day,,rabbit "tris(pentane-2,4-dionato)iron(III)",14024-18-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4ee6de76-ec68-4f86-a697-d7b961e8b34d/documents/dd5dda7a-7e11-429b-874f-8d50e2041895_40c7ddc5-997e-4b32-aea8-8bc39c98b316.html,Sub-chronic toxicity – systemic effects,inhalation,LOAEC,8.85 mg/m3,,rabbit "tris(pentane-2,4-dionato)iron(III)",14024-18-1," L’évaluation dela toxicité aiguë de la substance à enregistrer après administration par voie orale, cutanée et par inhalation montre que l’acétylacétonate de fer doit être considéré comme nocif en cas d'ingestion, de contact cutané ou d’inhalation. Conformément au règlement (CE) n° 1272/2008 et ses adaptations, la classification de l’acétylacétonate de fer est la suivante : Toxicité aigüe par voie orale : Catégorie 4 (Acute Tox. 4, H302). Toxicité aigüe par voie cutanée : Catégorie 4 (Acute Tox. 4, H312). Toxicité aigüe par inhalation: Catégorie 4 (Acute Tox. 4, H332). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ee6de76-ec68-4f86-a697-d7b961e8b34d/documents/523142ee-0d75-4007-8281-b4714f2b59c1_40c7ddc5-997e-4b32-aea8-8bc39c98b316.html,,,,,, "tris(pentane-2,4-dionato)iron(III)",14024-18-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ee6de76-ec68-4f86-a697-d7b961e8b34d/documents/523142ee-0d75-4007-8281-b4714f2b59c1_40c7ddc5-997e-4b32-aea8-8bc39c98b316.html,,oral,LD50,538 mg/kg bw,adverse effect observed, "tris(pentane-2,4-dionato)iron(III)",14024-18-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4ee6de76-ec68-4f86-a697-d7b961e8b34d/documents/523142ee-0d75-4007-8281-b4714f2b59c1_40c7ddc5-997e-4b32-aea8-8bc39c98b316.html,,dermal,LD50,"1,223 mg/kg bw",adverse effect observed, "Tris(pentane-2,4-dionato-O,O')cobalt",21679-46-9," L’évaluation dela toxicité aiguë de la substance à enregistrer après administration par voie orale, cutanée et par inhalation montre que l’acétylacétonate de Cobalt III doit être considéré comme nocif en cas d'ingestion et de contact cutané mais pas en cas d’inhalation. Conformément au règlement (CE) n° 1272/2008 et ses adaptations, la classification de l’acétylacétonate de Cobalt est la suivante : Toxicité aigüe par voie orale : Catégorie 4 (Acute Tox. 4, H302). Toxicité aigüe par voie cutanée : Catégorie 4 (Acute Tox. 4, H312) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1974b24f-b625-41f0-b246-10f1df5769e0/documents/2e6954d5-21f5-4aef-acf5-b127301f6825_1068bd07-2a34-4074-8384-65208908b001.html,,,,,, "Tris(pentane-2,4-dionato-O,O')cobalt",21679-46-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1974b24f-b625-41f0-b246-10f1df5769e0/documents/2e6954d5-21f5-4aef-acf5-b127301f6825_1068bd07-2a34-4074-8384-65208908b001.html,,oral,LD50,470 mg/kg bw,adverse effect observed, "Tris(pentane-2,4-dionato-O,O')cobalt",21679-46-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1974b24f-b625-41f0-b246-10f1df5769e0/documents/2e6954d5-21f5-4aef-acf5-b127301f6825_1068bd07-2a34-4074-8384-65208908b001.html,,dermal,LD50,"1,244 mg/kg bw",adverse effect observed, "Tris(pentane-2,4-dionato-O,O')vanadium",13476-99-8," The parent compound Vanadium-tris-acetylacetonate is rapidly hydrolysed to 2,4 -pentanedione (CAS no. 123 -54- 6) and Vanadyl acetylacetonate (CAS no. 3153 -26 -2) in the presence of water or moisture (> 80% hydrolysis after 1h at pH 1.2, 4, 7 and 9). Hence, the half life is < 1 h under neutral and acidic conditions. Accordingly, reliable data of the hydrolysis products 2,4-Pentadione (Cas no. 123-54-6) and Vanadyl acetylacetonate (3153-26-2) or comparable inorganic Vanadium compounds are used to address the endpoint, which is entirely appropriate to draw conclusions on the repeated dose toxiciy of Vanadium-tris-acetylacetonate to mammals. inhalation Acetylacetonate, rat, whole body, 6 h/day, 5 days/week, 14 weeks (OECD TG 413): NOEC = 420 mg/m3: LOEC 1277 mg/m3 V2O5 rat, whole body, 6 h/day, 5 days/week, 90 days (OECD TG 413, GLP): NOAEC = 1 mg/m3 - VAA NOAEC = 3.8 mg/m3 V2O5 rat, whole body, 6 h/day, 5 days/week, 104 weeks (OECD TG 413, GLP): LOAEC (alveolar neoplasms) = 0.5 mg/m3 - VAA LOAEC = 1.9 mg/m3 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d7a6c34-cddc-4474-bb69-ea91a2715780/documents/a06b051d-5142-4cc3-85c6-eb971c17e699_9c1c1c91-9871-4042-86ff-751b2e0bbf76.html,,,,,, "Tris(pentane-2,4-dionato-O,O')vanadium",13476-99-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d7a6c34-cddc-4474-bb69-ea91a2715780/documents/a06b051d-5142-4cc3-85c6-eb971c17e699_9c1c1c91-9871-4042-86ff-751b2e0bbf76.html,Chronic toxicity – systemic effects,inhalation,LOAEC,1.9 mg/m3,,rat "Tris(pentane-2,4-dionato-O,O')vanadium",13476-99-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2d7a6c34-cddc-4474-bb69-ea91a2715780/documents/a06b051d-5142-4cc3-85c6-eb971c17e699_9c1c1c91-9871-4042-86ff-751b2e0bbf76.html,Repeated dose toxicity – local effects,inhalation,LOAEC,1.9 mg/m3,adverse effect observed,rat "Tris(pentane-2,4-dionato-O,O')vanadium",13476-99-8," The parent compound Vanadium-tris-acetylacetonate is rapidly hydrolysed to 2,4 -pentanedione (CAS no. 123 -54- 6) and Vanadyl acetylacetonate (CAS no. 3153 -26 -2) in the presence of water or moisture (> 80% hydrolysis after 1h at pH 1.2, 4, 7 and 9). Hence, the half life is < 1 h under neutral and acidic conditions. Accordingly, reliable data of the hydrolysis products 2,4-Pentadione (Cas no. 123-54-6) and Vanadyl acetylacetonate (3153-26-2) or comparable inorganic Vanadium compounds are used to address the endpoint, which is entirely appropriate to draw conclusions on the acute toxicity of Vanadium-tris-acetylacetonate to mammals. oral V2O5 rat, single dose LD50 = 467 mg/kg bw (female), 470 mg/kg bw (male) - VAA LD50 = 1788 mg/kg bw (female), 1799.5 mg/kg bw (male) V2O3 rat, single dose LD50 = 5639 mg/kg bw (female), 8713 mg/kg bw (male) - VAA LD50 = 26216 mg/kg bw (female), 40507 mg/kg bw (male) NH4VO3 rat, single dose LD50 = 141 mg/kg bw (female), 218 mg/kg bw (male) - VAA LD50 = 424.2 mg/kg bw (female), 655.8 mg/kg bw (male) Acetylacetone rat, single dose LD50 = 578 mg/kg bw (female), 760 mg/kg bw (male) inhalation V2O5 rat, dust, 4 h, LC50 = 4.3 mg/L (female), 11.09 mg/L (male) - VAA LC50 = 16.5 mg/L (female), 42.5 mg/L (male) V2O3 rat, dust, 4 h, LC50 > 6.65 mg/L (female) - VAA LC50 > 30.9 mg/L (female) NH4VO3 rat, dust, 4 h, LC50 = 2.43 mg/L (female), 2.61 mg/L (male) - VAA LC50 = 7.3 mg/L (female), 7.9 mg/L (male) Acetylacetone rat, vapour, 4 h LC50 = 5.2 mg/L (female), 5.1 mg/L (male/female) dermal V2O5 rat, 24 h, LD50 > 2500 mg/kg bw - VAA LD50 > 9571.6 mg/kg bw V2O3 rat, 24 h, LD50 > 2500 mg/kg bw - VAA LD50 > 11622.7 mg/kg bw NH4VO3 rat, 24 h, LD50 > 2500 mg/kg bw - VAA LD50 > 7520 mg/kg bw Acetylacetone rabbit, 24 h LD50 = 793.8 mg/kg bw (female), 1381.8 mg/kg bw (male) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d7a6c34-cddc-4474-bb69-ea91a2715780/documents/1694750b-bb70-4b0b-a6a6-74ca412c1e69_9c1c1c91-9871-4042-86ff-751b2e0bbf76.html,,,,,, "Tris(pentane-2,4-dionato-O,O')vanadium",13476-99-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d7a6c34-cddc-4474-bb69-ea91a2715780/documents/1694750b-bb70-4b0b-a6a6-74ca412c1e69_9c1c1c91-9871-4042-86ff-751b2e0bbf76.html,,oral,LD50,424.2 mg/kg bw,adverse effect observed, "Tris(pentane-2,4-dionato-O,O')vanadium",13476-99-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d7a6c34-cddc-4474-bb69-ea91a2715780/documents/1694750b-bb70-4b0b-a6a6-74ca412c1e69_9c1c1c91-9871-4042-86ff-751b2e0bbf76.html,,dermal,LD50,793.8 mg/kg bw,adverse effect observed, "Tris(pentane-2,4-dionato-O,O')vanadium",13476-99-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2d7a6c34-cddc-4474-bb69-ea91a2715780/documents/1694750b-bb70-4b0b-a6a6-74ca412c1e69_9c1c1c91-9871-4042-86ff-751b2e0bbf76.html,,inhalation,LC50,"5,091 mg/m3",no adverse effect observed, Tris(p-isocyanatophenyl) thiophosphate,4151-51-3,The repeated dose toxicity of the test item was assessed in two in vivo studies: in a short-term repeated dose toxicity (inhalation) in rats (OECD TG 412) and in a sub-chronic oral toxicity study in rats (OECD TG 408). Based on the results of these studies no classification for repeated dose toxicity is warranted in accordance with CLP Regulation 1272/2008. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0feb669-1b6f-4e4e-90fa-0b9e17f51d98/documents/7561bfb8-b353-42cd-abce-cf8079c02890_6583b16b-29a2-43c6-a364-0a300746f30e.html,,,,,, Tris(p-isocyanatophenyl) thiophosphate,4151-51-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0feb669-1b6f-4e4e-90fa-0b9e17f51d98/documents/7561bfb8-b353-42cd-abce-cf8079c02890_6583b16b-29a2-43c6-a364-0a300746f30e.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,2.8 mg/m3,,rat Tris(p-isocyanatophenyl) thiophosphate,4151-51-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0feb669-1b6f-4e4e-90fa-0b9e17f51d98/documents/7561bfb8-b353-42cd-abce-cf8079c02890_6583b16b-29a2-43c6-a364-0a300746f30e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,80 mg/kg bw/day,,rat Tris(p-isocyanatophenyl) thiophosphate,4151-51-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e0feb669-1b6f-4e4e-90fa-0b9e17f51d98/documents/7561bfb8-b353-42cd-abce-cf8079c02890_6583b16b-29a2-43c6-a364-0a300746f30e.html,Repeated dose toxicity – local effects,inhalation,NOAEC,2.8 mg/m3,adverse effect observed,rat Tris(p-isocyanatophenyl) thiophosphate,4151-51-3,"In an acute oral toxicity study performed according to OECD TG 423 (acute toxic class method) in Wistar rats, the acute oral LD50 was >675 mg/kg bw. In an acute inhalation toxicity study (OECD TG 403) in Wistar rats, the acute inhalative LC50 in rats was determined to be 5721 mg/m³. No information is available on acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0feb669-1b6f-4e4e-90fa-0b9e17f51d98/documents/e10443e6-9bb6-48b4-b6d5-d6e672eaed97_6583b16b-29a2-43c6-a364-0a300746f30e.html,,,,,, Tris(p-isocyanatophenyl) thiophosphate,4151-51-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0feb669-1b6f-4e4e-90fa-0b9e17f51d98/documents/e10443e6-9bb6-48b4-b6d5-d6e672eaed97_6583b16b-29a2-43c6-a364-0a300746f30e.html,,oral,discriminating dose,> 675 mg/kg bw,no adverse effect observed, Tris(p-isocyanatophenyl) thiophosphate,4151-51-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e0feb669-1b6f-4e4e-90fa-0b9e17f51d98/documents/e10443e6-9bb6-48b4-b6d5-d6e672eaed97_6583b16b-29a2-43c6-a364-0a300746f30e.html,,inhalation,LC50,"5,721 mg/m3",adverse effect observed, Tris(triphenylphosphine)rhodium (I) chloride,14694-95-2,"The acute oral LD50 for chlorotris-(triphenylphosphine)-rhodium(I) was established to be above 5000 mg/kg bw in rats (Mayr, 1988a).No relevant acute dermal or inhalation toxicity data were identified, or are required at this tonnage. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f22333d-a27d-4274-b864-51e1ec3bb52c/documents/IUC5-99355860-826d-4f8d-a3e1-46df03f330a4_e0b65a61-4d32-4a8f-8eb4-b06583c14d78.html,,,,,, Tris(triphenylphosphine)rhodium (I) chloride,14694-95-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8f22333d-a27d-4274-b864-51e1ec3bb52c/documents/IUC5-99355860-826d-4f8d-a3e1-46df03f330a4_e0b65a61-4d32-4a8f-8eb4-b06583c14d78.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Tris[(2-hydroxyethyl)ammonium] citrate,21829-50-5,"The NOAEL of 614.6 mg/kg bw/day, based on the read-across with monoethanolamine, will be taken forward as a point of departure for DNEL derivation for tris[(2-hydroxyethyl)ammonium] citrate. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a85528c-03bf-4f4c-91f8-dedc3d666fb6/documents/IUC5-ca0d1b9d-06c6-4f11-82fb-18c38c8bffde_9780a89a-b999-4b47-8aa1-e2f406e118a1.html,,,,,, Tris[(2-hydroxyethyl)ammonium] citrate,21829-50-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0a85528c-03bf-4f4c-91f8-dedc3d666fb6/documents/IUC5-ca0d1b9d-06c6-4f11-82fb-18c38c8bffde_9780a89a-b999-4b47-8aa1-e2f406e118a1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,614.6 mg/kg bw/day,,rat Tris[(2-hydroxyethyl)ammonium] citrate,21829-50-5,"The calculated oral and dermal LD50 for tris[(2-hydroxyethyl)ammonium] citrate are > 2000 mg/kg bw, based on the read-across with monoethanolamine and citric acid. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a85528c-03bf-4f4c-91f8-dedc3d666fb6/documents/IUC5-578eae84-efda-4fa5-b8d1-6134ade85485_9780a89a-b999-4b47-8aa1-e2f406e118a1.html,,,,,, Tris[(2-hydroxyethyl)ammonium] citrate,21829-50-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a85528c-03bf-4f4c-91f8-dedc3d666fb6/documents/IUC5-578eae84-efda-4fa5-b8d1-6134ade85485_9780a89a-b999-4b47-8aa1-e2f406e118a1.html,,oral,LD50,"2,000 mg/kg bw",, Tris[(2-hydroxyethyl)ammonium] citrate,21829-50-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a85528c-03bf-4f4c-91f8-dedc3d666fb6/documents/IUC5-578eae84-efda-4fa5-b8d1-6134ade85485_9780a89a-b999-4b47-8aa1-e2f406e118a1.html,,dermal,LD50,"2,000 mg/kg bw",, Tris[2-[2-(2-methoxyethoxy)ethoxy]ethyl] orthoborate,30989-05-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Reliable with restrictions as TEGME (2-(2-(2-methoxyethoxy)ethoxy)ethanol, CAS 112-35-6) has been used as vehicle. TEGME itself has a subchronicrepeated dose oral NOAEL of 400 mg/kg bw in rats. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e64e862f-64a2-4e1e-881a-ec424cb3a159/documents/IUC5-7ac01ecd-97e2-42b4-a5b0-b00734f1fec4_90545b41-8da2-4ee5-9ed8-fcf077dc4c96.html,,,,,, Tris[2-[2-(2-methoxyethoxy)ethoxy]ethyl] orthoborate,30989-05-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e64e862f-64a2-4e1e-881a-ec424cb3a159/documents/IUC5-7ac01ecd-97e2-42b4-a5b0-b00734f1fec4_90545b41-8da2-4ee5-9ed8-fcf077dc4c96.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Tris[2-[2-(2-methoxyethoxy)ethoxy]ethyl] orthoborate,30989-05-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): For futher information, please refer to the Additional Information. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The existing inhalation study is of poor documentation quality and was not considered for an assessment. However, neither mortalities nor other adverse effects were observed. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): For futher information, please refer to the Additional Information. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e64e862f-64a2-4e1e-881a-ec424cb3a159/documents/IUC5-0142adf2-3711-403d-8dea-f59dc2ea811e_90545b41-8da2-4ee5-9ed8-fcf077dc4c96.html,,,,,, Tris[2-[2-(2-methoxyethoxy)ethoxy]ethyl] orthoborate,30989-05-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e64e862f-64a2-4e1e-881a-ec424cb3a159/documents/IUC5-0142adf2-3711-403d-8dea-f59dc2ea811e_90545b41-8da2-4ee5-9ed8-fcf077dc4c96.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Tris[2-[2-(2-methoxyethoxy)ethoxy]ethyl] orthoborate,30989-05-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e64e862f-64a2-4e1e-881a-ec424cb3a159/documents/IUC5-0142adf2-3711-403d-8dea-f59dc2ea811e_90545b41-8da2-4ee5-9ed8-fcf077dc4c96.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Tris[5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonato(2-)]dialuminium",68475-50-3,"5-amino-4-hydroxy-3-[(e)-phenyldiazenyl] naphthalene-2,7-disulfonic acid is non toxic by oral route ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90e42a9f-8b0f-4b28-8517-88a0e0cf4285/documents/IUC5-843a0e7f-782d-45f2-b5bf-96486ea11bde_9bb7649f-a270-451a-8034-1a851c6b6900.html,,,,,, "Tris[5-amino-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonato(2-)]dialuminium",68475-50-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90e42a9f-8b0f-4b28-8517-88a0e0cf4285/documents/IUC5-843a0e7f-782d-45f2-b5bf-96486ea11bde_9bb7649f-a270-451a-8034-1a851c6b6900.html,,oral,LD50,"9,816 mg/kg bw",no adverse effect observed, Tris[oxalate(2-)]dicerium,139-42-4,"Oral: NOEL = 150 mg/kg/day, 28 days rat male/female, OECD 422, CIT 2008. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1f0b0ec6-02aa-4615-a60b-b0ae0eddd7c4/documents/IUC5-b975fc8a-85fd-4022-891c-d803fdfeb535_b49417d1-2a09-4a70-bc6b-34920bcdace0.html,,,,,, Tris[oxalate(2-)]dicerium,139-42-4,ACUTE TOXICITY: ORALThe LD50 of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg bodyweight.ACUTE TOXICITY: DERMALThe LD50 of the test material in the Wistar strain rat was found to be greater than 2000 mg/kg bodyweight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f0b0ec6-02aa-4615-a60b-b0ae0eddd7c4/documents/IUC5-79aacd02-5a0a-4ef5-9e1f-a970ac6cdc8a_b49417d1-2a09-4a70-bc6b-34920bcdace0.html,,,,,, Tris[oxalato(2-)]digadolinium,867-64-1," Repeated dose toxicity - oral No studies on oral repeated dose toxicity are available for gadolinium oxalate. The endpoint is therefore covered using a study performed with the related substance gadolinium oxide. The key read across study (Papineau, 2017) was performed according to OECD guideline 422 and conform GLP requirements. In this study, gadolinium oxide was administered by oral gavage to male and female Sprague-Dawley rats, starting 2 weeks before mating, during mating and (for females) throughout gestation and until day 5 post-partum, at the dose levels of 110, 330 or 1200 (until day 17 of the study)/1008 (from day 18 of the study until end of exposure) mg/kg bw/day. In this study, the NOAEL for parental systemic toxicity was considered to be higher than or equal to 1008 mg/kg bw/day based on the absence of adverse findings related to the test item at the highest dose level. This is equivalent to a NOAEL higher than or equal to 1609 mg/kg bw/day when recalculated to gadolinium oxalate taking into account the gadolinium content of both substances. Based on these results, neither gadolinium oxide nor gadolinium oxalate need to be classified as STOT RE. The justification for read across is attached to IUCLID Section 13. Repeated dose toxicity - inhalation/dermal No key studies were identified for repeated dose toxicity after inhalation or dermal exposure to gadolinium oxalate. A key read across study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (Column 2, Annex VIII, Section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation or dermal route of exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3193da47-63fa-4049-8349-2291ee9267e9/documents/d2f092a7-e1e1-4265-81c1-17a50f21526b_938b0845-1a9a-466e-9638-30d52efdb331.html,,,,,, Tris[oxalato(2-)]digadolinium,867-64-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3193da47-63fa-4049-8349-2291ee9267e9/documents/d2f092a7-e1e1-4265-81c1-17a50f21526b_938b0845-1a9a-466e-9638-30d52efdb331.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,609 mg/kg bw/day",,rat Tris[oxalato(2-)]digadolinium,867-64-1," Acute oral toxicity The oral LD50 for rats was found to be > 2000 mg/kg bw in the key study, which was performed according to the acute toxic class method (OECD guideline 423) and conform GLP requirements (Mátyás, 2016). This study was considered reliable without restrictions (Klimisch 1). Acute toxicity via inhalation No key experimental data are available on the acute toxicity of gadolinium oxalate via inhalation, however, this route of exposure was considered not relevant for gadolinium oxalate because typically wet powders or dry powders with median particle size > 50 µm are manufactured. Acute dermal toxicity The acute oral LD50 is greater than 2000 mg/kg bw and no systemic effects or macroscopic abnormalities were observed in the study available for this endpoint. According to Annex VIII, column 2 of the REACH Regulation (revision May 2016), acute dermal toxicity can be waived if the substance under consideration is not classified as acute oral toxicant or as STOT SE, and no systemic effects have been observed in in vivo studies with dermal exposure. The latter criterion (in vivo skin sensitisation study, Tarcai, 2016) is also fulfilled. Therefore, it can be safely concluded that no adverse effects are expected upon acute dermal exposure to gadolinium oxalate. No acute dermal toxicity study should be performed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3193da47-63fa-4049-8349-2291ee9267e9/documents/6f2019b0-31ca-4a44-8fcf-2cd2cc42779e_938b0845-1a9a-466e-9638-30d52efdb331.html,,,,,, Tris[oxalato(2-)]dilutetium,3426-45-7," Acute oral toxicity The oral LD50 for rats was found to be > 2000 mg/kg bw in the key study, which was performed according to the acute toxic class method (OECD guideline 423) and in compliance with GLP requirements (Tarkai, 2017). This study was considered reliable without restrictions (Klimisch 1). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/300ec1ec-e887-40fd-967b-8bc7ae35cce6/documents/7f797b30-447a-4c5d-9e1e-b7d8e623f1ab_eaf3dcd3-b431-43af-9a77-62ff6500ace8.html,,,,,, Tris[oxalato(2-)]dilutetium,3426-45-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/300ec1ec-e887-40fd-967b-8bc7ae35cce6/documents/7f797b30-447a-4c5d-9e1e-b7d8e623f1ab_eaf3dcd3-b431-43af-9a77-62ff6500ace8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Trisilicon tetranitride,12033-89-5,A 28-day repeat dose oral toxicity study in rats resulted in a NOAEL of 1000 mg/kg/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f698f1f6-c18b-46fa-95fb-a3e1db72aaf7/documents/IUC5-c8c5d249-f4c1-4fb7-837f-fec7f7605829_febb1332-f18e-434d-a20f-9018d67d1d9e.html,,,,,, Trisilicon tetranitride,12033-89-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f698f1f6-c18b-46fa-95fb-a3e1db72aaf7/documents/IUC5-c8c5d249-f4c1-4fb7-837f-fec7f7605829_febb1332-f18e-434d-a20f-9018d67d1d9e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Trisilicon tetranitride,12033-89-5,LD50 for oral dose in rats is >2000 mg/mLLD50 for inhalation does in rates is >5.07 mg/LRequirement for dermal toxicity study is waived ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f698f1f6-c18b-46fa-95fb-a3e1db72aaf7/documents/IUC5-e752c98b-7c93-4b2d-8a3b-a1d0b965a168_febb1332-f18e-434d-a20f-9018d67d1d9e.html,,,,,, "Trisodium [2-[[α-[[2-hydroxy-5-sulpho-3-[(2,5,6-trichloro-4-pyrimidinyl)amino]phenyl]azo]benzyl]azo]-5-sulphobenzoato(5-)]cuprate(3-)",70161-20-5," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target substance Trisodium [2-[[alpha-[[2-hydroxy-5-sulpho-3-[(2,5,6-trichloro- 4-pyrimidinyl)amino]phenyl]azo]benzyl]azo]-5-sulphobenzoato(5-)]cupra (70161-20-5) was estimated to be 3193.56 mg/kg bw,and for different studies available on the structurally similar read across substance 5-[(4,6-dichloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-(phenylazo)naphthalene-2,7-disulphonic acid (6522-86-7) was considered to be 7460 mg/kg bw ; for 1-Amino-4-(2'-(4'',6''-dichloro-s-triazin-2-yl)amino)phenylamino)9,10-dihydro-9,10-dioxoanthracene-2,4'-disulphonic acid (13324-20-4) was considered to be 8980 mg/kg bw and for Aluminium, 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid complex (16521-38-3) was considered to be 5000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulationTrisodium [2-[[alpha-[[2-hydroxy-5-sulpho-3-[(2,5,6-trichloro- 4-pyrimidinyl)amino]phenyl]azo]benzyl]azo]-5-sulphobenzoato(5-)]cupra (70161-20-5) can be classified as category V of acute oral toxicity. Acute Dermal Toxicity: In Acute dermal toxicity, LD50 value was predicted based on OECD QSAR toolbox for target substanceTrisodium [2-[[alpha-[[2-hydroxy-5-sulpho-3-[(2,5,6-trichloro- 4-pyrimidinyl)amino]phenyl]azo]benzyl]azo]-5-sulphobenzoato(5-)]cupra (70161-20-5) was estimated to be 2277.52 mg/kg bw,and for differentstudies available on structurally similar read across substance Aluminium, 2-(1,3-dihydro-3-oxo-5-sulfo-2H-indol-2-ylidene)-2,3-dihydro-3-oxo-1H-indole-5-sulfonic acid complex (16521-38-3) was considered to be >2000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation,Trisodium [2-[[alpha-[[2-hydroxy-5-sulpho-3-[(2,5,6-trichloro- 4-pyrimidinyl)amino]phenyl]azo]benzyl]azo]-5-sulphobenzoato(5-)]cupra (70161-20-5) can be classified as category V of acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc5660df-b894-485a-94fc-33486093c3ee/documents/b9db060b-f309-4568-b438-d1ee13c20120_334dcb3b-ff06-4d95-83c6-7929110acc97.html,,,,,, "Trisodium [2-[[α-[[2-hydroxy-5-sulpho-3-[(2,5,6-trichloro-4-pyrimidinyl)amino]phenyl]azo]benzyl]azo]-5-sulphobenzoato(5-)]cuprate(3-)",70161-20-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc5660df-b894-485a-94fc-33486093c3ee/documents/b9db060b-f309-4568-b438-d1ee13c20120_334dcb3b-ff06-4d95-83c6-7929110acc97.html,,oral,LD50,"3,193.56 mg/kg bw",no adverse effect observed, "Trisodium [2-[[α-[[2-hydroxy-5-sulpho-3-[(2,5,6-trichloro-4-pyrimidinyl)amino]phenyl]azo]benzyl]azo]-5-sulphobenzoato(5-)]cuprate(3-)",70161-20-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dc5660df-b894-485a-94fc-33486093c3ee/documents/b9db060b-f309-4568-b438-d1ee13c20120_334dcb3b-ff06-4d95-83c6-7929110acc97.html,,dermal,LD50,"2,277.52 mg/kg bw",no adverse effect observed, "Trisodium [29H,31H-phthalocyaninetrisulphonato(5-)-N29,N30,N31,N32]cuprate(3-)",1330-39-8, The acute oral LD50 of FAT 20063 in rats was determined to be >10000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34e0f09c-40db-453f-a513-2876a5191552/documents/IUC5-1735a3ee-a72f-4a82-b8f4-5b8fd554a848_ef5aa372-272c-495f-bec6-dfa60af2eadf.html,,,,,, "Trisodium [29H,31H-phthalocyaninetrisulphonato(5-)-N29,N30,N31,N32]cuprate(3-)",1330-39-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34e0f09c-40db-453f-a513-2876a5191552/documents/IUC5-1735a3ee-a72f-4a82-b8f4-5b8fd554a848_ef5aa372-272c-495f-bec6-dfa60af2eadf.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Trisodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(3-)",69943-66-4,Oral LD50: 6620.9 mg/kg (6098.6 - 7187.9 mg/kg)Dermal LD50 > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd113ccc-4e5d-41a3-acaa-d6e21a185b6b/documents/IUC5-f5c6d137-7924-4c33-a8da-a386855c8fc5_aa704840-d14e-482a-879c-ddb895d180f2.html,,,,,, "Trisodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(3-)",69943-66-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd113ccc-4e5d-41a3-acaa-d6e21a185b6b/documents/IUC5-f5c6d137-7924-4c33-a8da-a386855c8fc5_aa704840-d14e-482a-879c-ddb895d180f2.html,,oral,LD50,"6,620.9 mg/kg bw",no adverse effect observed, "Trisodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)][2-hydroxy-3-[(2-hydroxy-1-naphthyl)azo]-5-nitrobenzenesulphonato(3-)]chromate(3-)",69943-66-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fd113ccc-4e5d-41a3-acaa-d6e21a185b6b/documents/IUC5-f5c6d137-7924-4c33-a8da-a386855c8fc5_aa704840-d14e-482a-879c-ddb895d180f2.html,,dermal,LD50,"5,000 mg/kg bw",adverse effect observed, "Trisodium [3-[[4-[[6-anilino-1-hydroxy-4-sulpho-2-naphthyl]azo]-5-hydroxy-o-tolyl]azo]naphthalene-1,5-disulphonato(5-)]cuprate(3-)",74664-50-9, NOAEL = 1000 mg/kg bw/day upon 28 days exposure. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/386b96af-ef83-4ec6-99fa-4292e309bc58/documents/5dd1d699-76aa-4e88-a85d-0e18f7f0dd63_ca16c3f7-067b-423c-86cb-d4453aedeb39.html,,,,,, "Trisodium [3-[[4-[[6-anilino-1-hydroxy-4-sulpho-2-naphthyl]azo]-5-hydroxy-o-tolyl]azo]naphthalene-1,5-disulphonato(5-)]cuprate(3-)",74664-50-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/386b96af-ef83-4ec6-99fa-4292e309bc58/documents/5dd1d699-76aa-4e88-a85d-0e18f7f0dd63_ca16c3f7-067b-423c-86cb-d4453aedeb39.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, "Trisodium [3-[[4-[[6-anilino-1-hydroxy-4-sulpho-2-naphthyl]azo]-5-hydroxy-o-tolyl]azo]naphthalene-1,5-disulphonato(5-)]cuprate(3-)",74664-50-9,LD50 (oral) = 4028 mg/kgLD50 (dermal) > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/386b96af-ef83-4ec6-99fa-4292e309bc58/documents/IUC5-43a0a73f-30c9-4ebb-8552-6720ce16dc53_ca16c3f7-067b-423c-86cb-d4453aedeb39.html,,,,,, "Trisodium [3-[[4-[[6-anilino-1-hydroxy-4-sulpho-2-naphthyl]azo]-5-hydroxy-o-tolyl]azo]naphthalene-1,5-disulphonato(5-)]cuprate(3-)",74664-50-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/386b96af-ef83-4ec6-99fa-4292e309bc58/documents/IUC5-43a0a73f-30c9-4ebb-8552-6720ce16dc53_ca16c3f7-067b-423c-86cb-d4453aedeb39.html,,oral,LD50,"4,028 mg/kg bw",no adverse effect observed, "Trisodium [3-[[4-[[6-anilino-1-hydroxy-4-sulpho-2-naphthyl]azo]-5-hydroxy-o-tolyl]azo]naphthalene-1,5-disulphonato(5-)]cuprate(3-)",74664-50-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/386b96af-ef83-4ec6-99fa-4292e309bc58/documents/IUC5-43a0a73f-30c9-4ebb-8552-6720ce16dc53_ca16c3f7-067b-423c-86cb-d4453aedeb39.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Trisodium [5-[[4-[(3-chloro-2-hydroxy-5-sulphophenyl)azo]-3-hydroxyphenyl]azoxy]-2-[2-(4-nitro-2-sulphophenyl)vinyl]benzenesulphonato(5-)]cuprate(3-),70304-38-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Reliability 2 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Reliability 2 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/162b2775-1596-41eb-91db-1a20eb16db35/documents/233321c1-31e0-43ed-9377-1d0fe02fbff3_d183968e-d32a-4582-9398-5b64bca1ac83.html,,,,,, Trisodium [5-[[4-[(3-chloro-2-hydroxy-5-sulphophenyl)azo]-3-hydroxyphenyl]azoxy]-2-[2-(4-nitro-2-sulphophenyl)vinyl]benzenesulphonato(5-)]cuprate(3-),70304-38-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/162b2775-1596-41eb-91db-1a20eb16db35/documents/233321c1-31e0-43ed-9377-1d0fe02fbff3_d183968e-d32a-4582-9398-5b64bca1ac83.html,,oral,discriminating dose,"6,491 mg/kg bw",adverse effect observed, Trisodium [5-[[4-[(3-chloro-2-hydroxy-5-sulphophenyl)azo]-3-hydroxyphenyl]azoxy]-2-[2-(4-nitro-2-sulphophenyl)vinyl]benzenesulphonato(5-)]cuprate(3-),70304-38-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/162b2775-1596-41eb-91db-1a20eb16db35/documents/233321c1-31e0-43ed-9377-1d0fe02fbff3_d183968e-d32a-4582-9398-5b64bca1ac83.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Trisodium [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]manganate(3-)",11065-74-0," In an extended oral OECD 422 study male animals were exposed for at least 13 weeks and females for almost 14 weeks. At the high dose level the following effects were observed: soft faeces (both sexes), decreased body weight gain (males), prolonged prothrombin time (males), increased haemoglobin concentration (males), decreased ALAT activity and chloride concentration (males) and decreased ALP activity and increased relative weights of kidneys and liver (both sexes). No toxicologically relevant changes were observed at the lower levels of 500 and 150 mg/kg bw. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a624323-6a74-47f0-98ca-53b9954ed4a5/documents/f5cafd41-218c-41b8-9b81-6b27d40c3065_4edefa59-d06c-40b1-b1a5-02d5fc9d6643.html,,,,,, "Trisodium [N,N-bis[2-[bis(carboxymethyl)amino]ethyl]glycinato(5-)]manganate(3-)",11065-74-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a624323-6a74-47f0-98ca-53b9954ed4a5/documents/f5cafd41-218c-41b8-9b81-6b27d40c3065_4edefa59-d06c-40b1-b1a5-02d5fc9d6643.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat "Trisodium [μ-[3-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-4,5-dihydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)",75284-35-4, The oral LD50 for Direct Blue 094 was found to be >7700 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82225c4f-6990-4e60-ba41-288292a6f973/documents/22623281-e68e-4acf-bf69-5da3c33c7a28_2c532d8c-5af2-4f7a-bbf1-b7fb12222932.html,,,,,, "Trisodium [μ-[3-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-4,5-dihydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)",75284-35-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/82225c4f-6990-4e60-ba41-288292a6f973/documents/22623281-e68e-4acf-bf69-5da3c33c7a28_2c532d8c-5af2-4f7a-bbf1-b7fb12222932.html,,oral,LD50,"7,700 mg/kg bw",no adverse effect observed, "Trisodium 1-amino-4-[[3-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",72927-99-2," The following information is available on the source substance: Administration of FAT 41001-H TE at dose levels of 100, 330 and 1000 mg/kg/day was well tolerated with no adverse effects on clinical condition, sensory reactivity, grip strength, motor activity, mating performance, fertility, gestation index, litter size, offspring survival or growth. At 330 and 1000 mg/kg/day, overall body weight gain was low for males during the treatment period. As food intake was unaffected in these animals a marginal impact on food conversion efficiency cannot be discounted. Between Day 6 and Day 19 of gestation, the mean food consumption of all groups of treated females was slightly higher than in Controls, and this continued during lactation at 330 or 1000 mg/kg/day. Findings observed at macroscopic examination of the F0 males and females treated at 330 or 1000 mg/kg/day were confined to blue or dark coloration (including some blue or dark colouration of the contents) in a variety of tissues; this was considered to be due to the coloured nature of the compound and was not representative of any pathological change. Treatment related microscopic changes were seen in the kidneys, lymph nodes, stomach and epididymides; none of these changes were considered to represent an adverse effect of treatment. Minimal to moderate epithelial vacuolation was observed in the kidney cortex of males and females given 330 or 1000 mg/kg/day with the severity greatest in females. Minimal to slight hyaline droplets were also recorded in the cortical tubular cells of males given 330 or 1000 mg/kg/day, but not in the females; hyaline droplet infiltration of the tubules may be observed in male rats exposed to a number of compounds. These changes observed in the kidney probably account for the increase in kidney weight in males and females treated with 1000 mg/kg/day observed at necropsy. In addition, on two occasions throughout the study, a marked increase in water consumption was observed amongst animals receiving 1000 mg/kg/day. Vacuolated histiocytes were observed within the sinuses of the mesenteric and left axillary lymph nodes. These changes observed in the lymph nodes are likely to represent storage of the test article in macrophages. In the stomach, foveolar hyperplasia was characterized by increased thickness of the epithelium of the foveolar region of the stomach. In the epididymis, minimal to slight epithelial vacuolation was recorded in the cauda region of males given 1000 mg/kg/day. The vacuolated cells are likely to be clear cells, which have taken up an endogenous or exogenous substance, possibly the test material or a metabolite. The clear cells in the controls were demonstrated by PAS, which strongly stained the lysosomal complexes; however not all vacuolated cells in the treated animals were PAS positive. There is no evidence of inflammation or degeneration and therefore this finding is not considered adverse at this severity. The mean absolute testes weights of males receiving 330 or 1000 mg/kg/day were significantly higher than Controls (attaining statistical significance at 1000 mg/kg/day); and mean absolute and adjusted adrenal weights of females were statistically significantly lower than Controls at all dose levels however, in the absence of any macroscopic or microscopic correlates, and no effect on the reproductive performance of the males, these findings were not considered to represent an adverse response to treatment with FAT 41001-H TE. The following inter-group differences were apparent in haematology/blood chemistry parameters: Mean cell haemoglobin concentration was high for males receiving FAT 41001-H TE at 100, 330 and 1000 mg/kg/day, when compared with Controls. Bile acid concentration was low amongst all treated groups of males and females (100, 330 and 1000 mg/kg/day) when compared with Controls. Cholesterol concentration was high in animals treated at 330 or 1000 mg/kg/day Compared with Controls. Creatinine was high in all female treated groups (100, 330 and 1000 mg/kg/day) when compared with Controls. Glucose concentration was low in males treated at 1000 mg/kg/day when compared with Controls. High calcium concentration was evident in all treated male groups when compared with the Control group. Since there was no effect of treatment on the survival, clinical condition or behavioural/reproductive performance of these animals, and no supporting macroscopic or microscopic changes were detected in the full list of tissues examined, these differences in haematology/blood chemistry parameters are considered not to reflect an adverse effect of treatment. It was therefore concluded that in the absence of any evidence for general systemic toxicity or effects on reproductive performance/offspring development that the no observed adverse effect level was 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c092ad1-dc08-4f81-92ed-0b4a3d6783d5/documents/58b5496e-df9a-4a86-914e-865c13100ee8_0317fce7-0234-4938-8bb1-78c53c273851.html,,,,,, "Trisodium 1-amino-4-[[3-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",72927-99-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7c092ad1-dc08-4f81-92ed-0b4a3d6783d5/documents/58b5496e-df9a-4a86-914e-865c13100ee8_0317fce7-0234-4938-8bb1-78c53c273851.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Trisodium 1-amino-4-[[3-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",72927-99-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7c092ad1-dc08-4f81-92ed-0b4a3d6783d5/documents/8e5bfa12-6b1c-43ba-9cdd-8d14a10b23b2_0317fce7-0234-4938-8bb1-78c53c273851.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",72214-18-7,"Based on the results obtained from a OECD guideline 422 study, performed in accordance to GLP, NOAEL (No Observed Adverse Effect Level) for males and females was established at 1000 mg/kg body weight/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b14f2b0e-e304-4c2a-b185-cb02bdf6fc72/documents/IUC5-a015cb37-f6aa-4bc7-874b-a61382e4fc0d_9b1ff1f1-f678-4fa7-a4a3-604223a0cdb3.html,,,,,, "Trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",72214-18-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b14f2b0e-e304-4c2a-b185-cb02bdf6fc72/documents/IUC5-a015cb37-f6aa-4bc7-874b-a61382e4fc0d_9b1ff1f1-f678-4fa7-a4a3-604223a0cdb3.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",72214-18-7,Based on the data of three studies it can be concluded that the test substance FAT 41001 is not toxic by oral route. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b14f2b0e-e304-4c2a-b185-cb02bdf6fc72/documents/IUC5-9bfe0cfc-c530-4876-8a0f-da3be16165a8_9b1ff1f1-f678-4fa7-a4a3-604223a0cdb3.html,,,,,, "Trisodium 1-amino-4-[[3-[[4-chloro-6-[(sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2,4,6-trimethyl-5-sulphonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-sulphonate",72214-18-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b14f2b0e-e304-4c2a-b185-cb02bdf6fc72/documents/IUC5-9bfe0cfc-c530-4876-8a0f-da3be16165a8_9b1ff1f1-f678-4fa7-a4a3-604223a0cdb3.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium 2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonate",20298-05-9," Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for trisodium 2-[(E)-2-(3-methyl-5-oxo-1-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl} -4,5-dihydro-1H- pyrazol-4-yl) diazen-1-yl] naphthalene-1,5-disulfonate. The study assumed the use of male and female Wistar rats in a sub-chronic toxicity study. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Level (NOAEL) for trisodium 2-[(E)-2-(3-methyl-5-oxo-1-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}-4,5-dihydro-1H-pyrazol-4-yl)diazen-1-yl] naphthalene-1,5-disulfonate is predicted to be 314.892852783 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/162b5203-251a-48b9-a710-20b520730bfa/documents/a8031b46-ce71-4a17-a34b-688e1d462e81_079d06cd-9801-46f7-9bca-3aea55e927c9.html,,,,,, "Trisodium 2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonate",20298-05-9,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/162b5203-251a-48b9-a710-20b520730bfa/documents/a8031b46-ce71-4a17-a34b-688e1d462e81_079d06cd-9801-46f7-9bca-3aea55e927c9.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,314.893 mg/kg bw/day,,rat "Trisodium 2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonate",20298-05-9," Acute Oral Toxicity:  In Acute oral toxicity ,LD50 value was predicted based on OECD QSAR toolbox for target substance trisodium 2-[(E)-2-(3-methyl-5-oxo-1-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}-4,5-dihydro-1H-pyrazol-4-yl)diazen-1-yl]naphthalene-1,5-disulfonate (20298-05-9) was estimated to be 3730.47 mg/kg bw,and for differentstudies available on the structurally similar read across substance Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate (CAS No. 2519-30-4) was considered to be 5000 mg/kg bw; for Tartrazine (1934-21-0) was considered to be >2000 mg/kg bw; for Disodium 6-hydroxy-5-[(4-sulphonatophenyl)azo]naphthalene-2-sulphonate(2783-94-0) was considered to be >10000 mg/kg bw and >6000 mg/kg bw.All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, trisodium 2-[(E)-2-(3-methyl-5-oxo-1-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}-4,5-dihydro-1H-pyrazol-4-yl)diazen-1-yl]naphthalene-1,5-disulfonate (20298-05-9) cannot be classified for acute oral toxicity. Acute Inhalation Toxicity:  Trisodium 2-[(E)-2-(3-methyl-5-oxo-1-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}-4,5-dihydro-1H-pyrazol-4-yl)diazen-1-yl]naphthalene-1,5-disulfonate (20298-05-9) has very low vapor pressure (7.62E-028 Pa.).So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver. Acute Dermal Toxicity: In Acute dermal toxicity, LD50 value was predicted based on OECD QSAR toolbox for target substance Trisodium 2-[(E)-2-(3-methyl-5-oxo-1-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}-4,5-dihydro-1H-pyrazol-4-yl)diazen-1-yl]naphthalene-1,5-disulfonate (20298-05-9) was estimated to be 6322.25 mg/kg bw,and for differentstudies available on structurally similar read across substance Tetra sodium 1-acetamido-2-hydroxy-3-(4-((4-sulphonatophenylazo)-7-sulphonato-1-naphthylazo))naphthalene-4,6-disulphonate (CAS No. 2519-30-4) was considered to be >2000 mg/kg bw and for disodium (5E)-5-[2-(2-methoxy-5-methyl-4-sulfonatophenyl)hydrazin-1-ylidene]-6-oxo-5,6-dihydronaphthalene-2-sulfonate (25956-17-6) was considered to be >10000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Trisodium 2-[(E)-2-(3-methyl-5-oxo-1-{4-[2-(sulfonatooxy)ethanesulfonyl]phenyl}-4,5-dihydro-1H-pyrazol-4-yl)diazen-1-yl]naphthalene-1,5-disulfonate (20298-05-9) cannot be classified for acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/162b5203-251a-48b9-a710-20b520730bfa/documents/ae6d6e31-5879-4498-bae5-e29c11360415_079d06cd-9801-46f7-9bca-3aea55e927c9.html,,,,,, "Trisodium 2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonate",20298-05-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/162b5203-251a-48b9-a710-20b520730bfa/documents/ae6d6e31-5879-4498-bae5-e29c11360415_079d06cd-9801-46f7-9bca-3aea55e927c9.html,,oral,LD50,"2,577.06 mg/kg bw",no adverse effect observed, "Trisodium 2-[[4,5-dihydro-3-methyl-5-oxo-1-[4-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]-1H-pyrazol-4-yl]azo]naphthalene-1,5-disulphonate",20298-05-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/162b5203-251a-48b9-a710-20b520730bfa/documents/ae6d6e31-5879-4498-bae5-e29c11360415_079d06cd-9801-46f7-9bca-3aea55e927c9.html,,dermal,LD50,"6,322.25 mg/kg bw",no adverse effect observed, "Trisodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonatonaphthyl]azo]-2,5-dimethylphenyl]azo]benzene-1,4-disulphonate",70210-13-8,The oral and dermal LD50 for Reactive Orange 35 was considered to be >2000 mg/kg bw in rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf68d19e-6995-4504-8cb6-ecabd428624f/documents/IUC5-8354a5be-4eb4-419b-bc3b-02625461e8aa_45d7f517-3cd9-4d50-baac-5d0a163456ce.html,,,,,, "Trisodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonatonaphthyl]azo]-2,5-dimethylphenyl]azo]benzene-1,4-disulphonate",70210-13-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf68d19e-6995-4504-8cb6-ecabd428624f/documents/IUC5-8354a5be-4eb4-419b-bc3b-02625461e8aa_45d7f517-3cd9-4d50-baac-5d0a163456ce.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonatonaphthyl]azo]-2,5-dimethylphenyl]azo]benzene-1,4-disulphonate",70210-13-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bf68d19e-6995-4504-8cb6-ecabd428624f/documents/IUC5-8354a5be-4eb4-419b-bc3b-02625461e8aa_45d7f517-3cd9-4d50-baac-5d0a163456ce.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium 2-[[6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)methylamino]-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate",70616-89-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16e8182b-2291-4aa4-ba9d-f2d65a6e8dbf/documents/c7865009-eb6e-41b9-a903-4e69d0772515_ab98fa1d-0a3c-4c98-bda4-93e9beca09c4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Trisodium 2-[[6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)methylamino]-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate",70616-89-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16e8182b-2291-4aa4-ba9d-f2d65a6e8dbf/documents/b7fa7133-9335-481e-a84a-6b7b4b824d7f_ab98fa1d-0a3c-4c98-bda4-93e9beca09c4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium 2-[[6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)methylamino]-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate",70616-89-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16e8182b-2291-4aa4-ba9d-f2d65a6e8dbf/documents/b7fa7133-9335-481e-a84a-6b7b4b824d7f_ab98fa1d-0a3c-4c98-bda4-93e9beca09c4.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Trisodium 2-[[6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)methylamino]-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-1,5-disulphonate",70616-89-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16e8182b-2291-4aa4-ba9d-f2d65a6e8dbf/documents/b7fa7133-9335-481e-a84a-6b7b4b824d7f_ab98fa1d-0a3c-4c98-bda4-93e9beca09c4.html,,inhalation,LC50,"5,000 mg/m3",no adverse effect observed, "Trisodium 3-[[4-[[6-(anilino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]-5-methoxy-o-tolyl]azo]naphthalene-1,5-disulphonate",6227-20-9," Three groups of ten male and ten female rats received the substance at doses of 5, 15 or 40 mg/kg/day by oral gavage administration. Males were treated daily for two weeks before pairing, up to necropsy after a minimum of five consecutive weeks. Females were treated daily for two weeks before pairing, throughout pairing, gestation and until Day 13 of lactation. Females were allowed to litter, rear their offspring and were killed on Day 14 of lactation. The F1 generation received no direct administration of the test item; any exposure was in utero or via the milk. A similarly constituted Control group received the vehicle, water, at the same volume-dose as treated groups. During the study, clinical condition, detailed physical examination and arena observations, sensory reactivity observations, grip strength, motor activity, body weight, food consumption, hematology (peripheral blood), blood chemistry, thyroid hormone analysis (T4), estrous cycles, pre-coital interval, mating performance, fertility, gestation length, organ weight and macroscopic pathology and histopathology investigations were undertaken. Two animals died prematurely; these deaths were considered incidental and not related to treatment. There were no treatment related adverse effects of treatment on clinical condition, sensory reactivity, grip strength, body weight gain, food intake, haematology, blood chemistry or organ weight measurements in males and females.  The assessment of motor activity scores indicated that males receiving 40 mg/kg/day were slightly less active than the control males. Estrous cyclicity was unaffected by the administration of the substance at all dose levels. Out of 10 females that mated in Group 4 (40 mg/kg/day), only five achieved pregnancy Hematological examination for males revealed, when compared with controls, slightly low hematocrit counts attaining statistical significance at 15 or 40 mg/kg/day. A slight increase in mean cell volume (attaining statistical significance) was observed in females treated at 40 mg/kg/day. In addition a decrease of the number of lymphocytes was seen in females at 40 mg/kg bw. Biochemical evaluation revealed no treatment-related findings. At the macroscopic examination of the adult animals no treatment related effects were observed. Pale areas in heart and kidneys could be related to mineralization as observed during histopathological examination. At the microscopic examination of the adult animals changes related to treatment with the substance were seen in males at 40 mg/kg bw. These findings included minimal to slight degeneration/atrophy in the testes in 4/9 males treated at 40 mg/kg/day. A minimal increase in luminal cell debris in the epididymides was seen in the majority of males treated at 40 mg/kg/day; this was also present in one animal given 15 mg/kg/day,but at this dose level the incidence and severity is within the historical control range (0 -20%). In three animals given 40 mg/kg/day, the luminal cell debris were associated with minimal to moderate interstitial inflammatory cell infiltrate.  Oral administration of the substance was well tolerated in the adult animals but was associated with changes in the testes and epididymides of males treated at 40 mg/kg/day. A reduction in fertility at 40 mg/kg/day was also evident with only 5 / 10 females pregnant, however, there was no correlation between the findings in the testes and those females which were found not pregnant; as such it remains unclear if the reduced fertility must be attributed to the males or the females treated with the substance. Apart from the reduction in fertility, there was no systemic toxicity detected in females treated with the substance. The no-observed-adverse-effect-level (NOAEL) for systemic toxicity was considered to be 15 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b737200-9b81-4c2f-a51b-465f24c18063/documents/c6c3a3b9-a447-4332-8049-f0265e2c29c3_9cc794ef-9e75-4cc6-8d29-b04d64c83aee.html,,,,,, "Trisodium 3-[[4-[[6-(anilino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]-5-methoxy-o-tolyl]azo]naphthalene-1,5-disulphonate",6227-20-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6b737200-9b81-4c2f-a51b-465f24c18063/documents/c6c3a3b9-a447-4332-8049-f0265e2c29c3_9cc794ef-9e75-4cc6-8d29-b04d64c83aee.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat "Trisodium 3-[[4-[[6-(anilino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]-5-methoxy-o-tolyl]azo]naphthalene-1,5-disulphonate",6227-20-9," In a fixed dose procedure female rats received a single dose of 2000 (1 female) and 300 mg/kg bw (5 females) by gavage. Rats were observed for 14 days thereafter. The female at 2000 mg/kg bw died within one day after dosing showing reduced body weight, purple staining of the urine and abnormally red lungs, dark liver, dark kidneys, dark purple coloured substance present in the stomach and purple colored staining of the small intestine. Females at 300 mg/kg did not show any effects on body weight, clinical signs and macroscopic investigations. The faeces of 4 of these females was purple stained. Based on these findings the oral LD50 of the substance is between 300 and 2000 mg/kg bw. In a test according to OECD 402 Wistar rats (5/sex) received 2000 mg/kg bw of the test substance on the skin during 24 hours. During the 14 day observation period no mortality and clinical signs were observed. Body weight was in normal ranges except for one female. Another female developed scabs. No abnormalities were found at necropsy. The LD50 of the substance is > 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b737200-9b81-4c2f-a51b-465f24c18063/documents/8c35dda0-c887-49fd-a29e-d3221af4170a_9cc794ef-9e75-4cc6-8d29-b04d64c83aee.html,,,,,, "Trisodium 3-[[4-[[6-(anilino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]-5-methoxy-o-tolyl]azo]naphthalene-1,5-disulphonate",6227-20-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b737200-9b81-4c2f-a51b-465f24c18063/documents/8c35dda0-c887-49fd-a29e-d3221af4170a_9cc794ef-9e75-4cc6-8d29-b04d64c83aee.html,,oral,LD50,300 mg/kg bw,adverse effect observed, "Trisodium 3-[[4-[[6-(anilino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]-5-methoxy-o-tolyl]azo]naphthalene-1,5-disulphonate",6227-20-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6b737200-9b81-4c2f-a51b-465f24c18063/documents/8c35dda0-c887-49fd-a29e-d3221af4170a_9cc794ef-9e75-4cc6-8d29-b04d64c83aee.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium 4-[[4-chloro-6-[(4-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-[[1-(2,5-dichloro-4-sulphonatophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]benzenesulphonate",50662-99-2," LD50 was estimated to be 2834 mg/kg bw when Wistar female rats were orally exposed with trisodium 2,5-dichloro-4-(4-{[5-({4-chloro-6-[(4-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)-2-sulfonatophenyl]diazenyl}-3-methyl-5-oxo-4,5-dihydro-1H-pyrazol-1-yl)benzenesulfonate. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d401869-6f8e-478c-a194-e2c03e711fee/documents/ab581859-e302-4826-accb-5c0d59bc51f0_c78c87ed-eccc-4f0b-8e91-b6ee83dd620c.html,,,,,, "Trisodium 4-[[4-chloro-6-[(4-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-[[1-(2,5-dichloro-4-sulphonatophenyl)-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-4-yl]azo]benzenesulphonate",50662-99-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4d401869-6f8e-478c-a194-e2c03e711fee/documents/ab581859-e302-4826-accb-5c0d59bc51f0_c78c87ed-eccc-4f0b-8e91-b6ee83dd620c.html,,oral,LD50,"2,834 mg/kg bw",no adverse effect observed, "Trisodium 4-amino-5-hydroxy-3-[[4-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]azo]-6-[(4-sulphonato-1-naphthyl)azo]naphthalene-2,7-disulphonate",79135-92-5," LD50 (oral, rat) > 5000 mg/kg b.w LD50 (dermal, rat) > 5000 mg/kg b.w ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0699674c-75fc-40f4-b04c-a14e00b5272d/documents/ecb373f8-ec62-4bd6-bebd-963021e5a395_4e707800-2005-4533-8a54-025fa360bcc0.html,,,,,, trisodium 4-hydroxy-6-(sulfonatomethylamino)-5-(2-(2-sulfatoethylsulfonyl)phenylazo)naphthalene-2-sulfonate,844491-96-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c98e1ca7-cd9c-4c53-97b5-508010cc3d05/documents/60d9bd51-b01d-46ec-944c-f6e470c7eee6_fdf038ad-d984-4150-964e-ca30bb4aaf6a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium 5-[[2,4-dihydroxy-5-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]phenyl]azo]-8-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]naphthalenesulphonate",72496-92-5, No biologically significant signs of toxicity were observed. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a695f595-df7f-4591-9ca4-bc87ce86a887/documents/d8818e6c-87b9-4925-a091-a9d05e37d201_04100184-1ceb-43b1-b494-51a54b76587a.html,,,,,, "Trisodium 5-[[2,4-dihydroxy-5-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]phenyl]azo]-8-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]naphthalenesulphonate",72496-92-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a695f595-df7f-4591-9ca4-bc87ce86a887/documents/d8818e6c-87b9-4925-a091-a9d05e37d201_04100184-1ceb-43b1-b494-51a54b76587a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Trisodium 5-[[2,4-dihydroxy-5-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]phenyl]azo]-8-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]naphthalenesulphonate",72496-92-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a695f595-df7f-4591-9ca4-bc87ce86a887/documents/4d5ebbe8-bbbe-4eec-bbe5-a5ef0d22f2d3_04100184-1ceb-43b1-b494-51a54b76587a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium 5-[[2,4-dihydroxy-5-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]phenyl]azo]-8-[[4-[(4-nitro-2-sulphonatophenyl)amino]phenyl]azo]naphthalenesulphonate",72496-92-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a695f595-df7f-4591-9ca4-bc87ce86a887/documents/4d5ebbe8-bbbe-4eec-bbe5-a5ef0d22f2d3_04100184-1ceb-43b1-b494-51a54b76587a.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(1-sulphonato-2-naphthyl)azo]naphthalene-2,7-disulphonate",84045-65-8, The no-observed-effect-level (NOEL) of FAT 40850/A TE could not be established. The no-observed-adverse-effect-level (NOAEL) was established at 300 mg/kg/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1fa16876-5c3e-4f5d-9bf2-f0a4add3deb9/documents/73b473ad-45bf-4b7e-ae3c-fc31320afe93_ea229962-6e0f-4fb8-be80-247dc0467802.html,,,,,, "Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(1-sulphonato-2-naphthyl)azo]naphthalene-2,7-disulphonate",84045-65-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1fa16876-5c3e-4f5d-9bf2-f0a4add3deb9/documents/73b473ad-45bf-4b7e-ae3c-fc31320afe93_ea229962-6e0f-4fb8-be80-247dc0467802.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(1-sulphonato-2-naphthyl)azo]naphthalene-2,7-disulphonate",84045-65-8, The acute oral and dermal LD50 of FAT 40147 is greater than 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fa16876-5c3e-4f5d-9bf2-f0a4add3deb9/documents/6a73a243-098c-49d5-8986-3da451ff9863_ea229962-6e0f-4fb8-be80-247dc0467802.html,,,,,, "Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(1-sulphonato-2-naphthyl)azo]naphthalene-2,7-disulphonate",84045-65-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fa16876-5c3e-4f5d-9bf2-f0a4add3deb9/documents/6a73a243-098c-49d5-8986-3da451ff9863_ea229962-6e0f-4fb8-be80-247dc0467802.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(1-sulphonato-2-naphthyl)azo]naphthalene-2,7-disulphonate",84045-65-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1fa16876-5c3e-4f5d-9bf2-f0a4add3deb9/documents/6a73a243-098c-49d5-8986-3da451ff9863_ea229962-6e0f-4fb8-be80-247dc0467802.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate",72829-25-5," Acute toxicity: oral Data on acute oral toxicity test was not available for the target substance (Reactive Red 024:1). To fill the data gaps, read across approach is adapted using similar substance Reactive Red 024. So, in a key study, an acute oral toxicity of FAT 40034 was evaluated in a limit test using Sprague-Dawley rats according to a methodology similar to OECD Guideline 401. 5 males and 5 females were administered a single dose of 5000 mg/kg bw orally. After administration of the compound, the animals were observed for 14 days. Deaths and clinical symptoms were recorded. At the end of the observation period, surviving animals were killed by exsanguination under ether anaesthesia and an autopsy performed. No clinical symptoms were recorded and no deaths occurred. At autopsy no changes caused by the administration of FAT 40034/A were seen. Based on the read across data generated from the acute oral toxicity of Reactive Red 024, the acute oral median lethal dose (LD50) of target substance (Reactive Red 024:1) is also considered to be greater than 5000 mg/kg bw. In a supporting study, an acute oral toxicity of FAT 40034 the acute oral LD50 was identified to 8600 mg/kg bw. Acute toxicity: inhalation Data on acute inhalation toxicity test was not available for the target substance (Reactive Red 024:1). To fill the data gaps, read across approach is adapted using similar substance Reactive Red 024. A study was performed to determine the inhalation toxicity of FAT 40034/B in Tif: RAIF (SPF) rats. 10 males and 10 females were exposed to the test concentration of 1552 mg/m³ for 4 h in a nose-only exposure system. The concentration and the particle size distribution of the dust in the vicinity of the animals was monitored at 1 h intervals throughout the dust exposure. The size distribution of the dust particles was measured with a Cascade Impactor with selectron filters of 25 mm diameter and with a pore size of 0.2 µm. During the 4-h exposure period and the subsequent 14 observation days, no toxic symptoms were observed. No substance related gross organ changes were recorded at the necropsy. No mortality was seen during the study. Based on the read across data generated from the acute inhalation toxicity of Reactive Red 024, the LC50 of target substance (Reactive Red 024:1) is also considered to >1500 mg/m³ air. Acute dermal toxicity: Currently no study to assess acute dermal toxicity of FAT 40034 is available. However, read across substance FAT 40850 (Reactive Red 286) was evaluated for the acute toxicity via dermal route. In this GLP-compliant dermal toxicity study, performed according to OECD Guideline 402, Wistar rats (5/sex) were administered FAT 40850 at the dose of 2000 mg/kg bw. Neither mortality nor clinical signs were observed during the observation period. In all animals, strong violet staining produced by the test substance was noted on the treated skin area from test day 2 up to test day 6 or 9. However, this staining prevented the assessment of possible erythema. When assessable, no local dermal signs were observed in all animals. Under the study conditions, based on this read-across data generated with FAT 40850/A, the acute dermal median lethal dose (LD50) of Reactive Red 024:1 is also considered to be greater than 2000 mg/kg. The molecular weight of FAT 40034 is 802.1 g/mol, which indicates substance is too large for dermal absorption. The high water solubility (434 g/L) and low partition coefficient (log Pow = -3.52) of FAT 40034, indicate the substance may be too hydrophilic to cross the lipid rich environment of the stratum corneum. Hence, the dermal uptake for the substance is expected to be low. Further, the absence of systemic toxicity or mortality in skin irritation as well as sensitization studies, further supports the conclusion that low acute toxicity is expected via dermal route. Taking above discussion and the results of acute dermal toxicity with source substance FAT 40850 into account, no hazard is expected in case of dermal exposure of FAT 40034, hence, further experiments to assess acute dermal toxicity are not taken into account. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b1fb8bd-263c-4cbe-86b3-f3071a44ee38/documents/e2ac0228-bb1f-473f-9399-0656680d3121_4c1933a8-0af4-47c7-8071-fb375354cc2e.html,,,,,, "Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate",72829-25-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b1fb8bd-263c-4cbe-86b3-f3071a44ee38/documents/e2ac0228-bb1f-473f-9399-0656680d3121_4c1933a8-0af4-47c7-8071-fb375354cc2e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate",72829-25-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b1fb8bd-263c-4cbe-86b3-f3071a44ee38/documents/e2ac0228-bb1f-473f-9399-0656680d3121_4c1933a8-0af4-47c7-8071-fb375354cc2e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate",72829-25-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2b1fb8bd-263c-4cbe-86b3-f3071a44ee38/documents/e2ac0228-bb1f-473f-9399-0656680d3121_4c1933a8-0af4-47c7-8071-fb375354cc2e.html,,inhalation,LC50,"1,500 mg/m3",no adverse effect observed, "Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate",73816-74-7," - Oral: NOAEL = 300 mg/kg bw/day for both sexes, based on data from a GLP compliant OECD 408 study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c1351ef-3432-4b26-bc4e-4f54d05b46bc/documents/d77c80f1-d5b6-44fd-bfdc-a804ca01bd3f_a0db1f46-eee7-4c4e-8449-bfc4c67cf2e3.html,,,,,, "Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate",73816-74-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3c1351ef-3432-4b26-bc4e-4f54d05b46bc/documents/d77c80f1-d5b6-44fd-bfdc-a804ca01bd3f_a0db1f46-eee7-4c4e-8449-bfc4c67cf2e3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat "Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate",73816-74-7," Acute Toxicity/Oral LD50=6,16 g/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c1351ef-3432-4b26-bc4e-4f54d05b46bc/documents/7c14aa62-4ddb-46c6-805d-7865fd3b3a76_a0db1f46-eee7-4c4e-8449-bfc4c67cf2e3.html,,,,,, "Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methyl-2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate",73816-74-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3c1351ef-3432-4b26-bc4e-4f54d05b46bc/documents/7c14aa62-4ddb-46c6-805d-7865fd3b3a76_a0db1f46-eee7-4c4e-8449-bfc4c67cf2e3.html,,oral,LD50,"6,160 mg/kg bw",no adverse effect observed, "Trisodium 5-[[4-chloro-6-(methylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate",70210-20-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dbd9300d-6ae8-4d15-ad8c-8c5a9650b443/documents/68cde271-1992-4a1f-860c-5acd569664c2_cceef9cc-c40f-4e2e-86b4-35dbfc5bb77c.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Trisodium 5-[[4-chloro-6-[(o-tolyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate",93941-05-0, Acute toxicity: via oral route The LD50 of Reactive Red 3 -1 was greater than 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7738bfd3-b90f-42cf-8f5a-12aaf9a21019/documents/9a3e94ab-a7d2-449f-81da-d4e6e2f8a55f_591c5e46-cbf6-480f-acc9-c418e1901007.html,,,,,, "Trisodium 5-[[4-chloro-6-[(o-tolyl)amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate",93941-05-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7738bfd3-b90f-42cf-8f5a-12aaf9a21019/documents/9a3e94ab-a7d2-449f-81da-d4e6e2f8a55f_591c5e46-cbf6-480f-acc9-c418e1901007.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium 5-[[5-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl]azo]-1-ethyl-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-3-methanesulphonate",84045-63-6," In a GLP compliant repeated dose oral toxicity study, performed according to OECD guideline 407, Wistar rats were treated with the source substance (0, 50, 200, and 1000 mg/kg bw) by repeated oral gavage, for a period of 28 days. The study was comprised of 4 groups, the groups comprised 5 animals per sex that were sacrificed after 28 days of treatment. Additional 5 rats per sex and group were used at 0 and 1000 mg/kg bw. These animals were treated for 28 days and then allowed a 14-day treatment-free recovery period after which they were sacrificed. The following results were obtained: - Mortality: No death occurred. - Clinical signs: Sedation was observed in two male rats of group 4 (1000 mg/kg bw) at day 8 of the treatment period. No other clinical signs were noted in the control or test article treated animals during treatment and recovery period. - Food consumption: No significant differences in food consumption were observed during treatment and/or recovery period between the animals of the control and test article treated groups. - Body weights: No significant differences in body weights were observed during treatment and/or recovery period between the animals of the control and test article treated groups. - Ophthamlnoscopic examinations: No treatment-related findings were noted at termination of treatment and/or recovery period. - Clinical laboratory investigations: The assessment of hematological, biochemical and urinalysis data indicated no changes of toxicolglcal significance at the end of the treatment, nor at the end of the treatment-free (recovery) period. However, a slightly higher incidence of proteinuria was noted for both sexes of animals in the 1000 mg/kg bw group after 4 weeks. This findings in the absence of morphological changes in the kidney, is considered to be a transient physiological proteinuria and not of toxicological relevance. Treatment-unrelated: All other differences in the results of the hematology, clinical biochemistry and urinalysis parameters were considered to be incidental and of normal biological variation. Based on other hematological data in the present study and on historical data, it can be concluded that there was no effect on Heinz body and methemoglobin formation after 4 weeks of treatment. - Organ weights: After the 4 week treatment period, the female rats of group 4 (1000 mg/kg bw) showed statistically significant increased liver weight and ratios when the results were compared with those findings of groups 1 (control), 2 (50 mg/kg bw) and 3 (200 mg/kg bw). After 6 weeks the ratios from testes of male rats of group 4 were statistically significant decreased when compared with the controls. These differences were considered to be incidental and of no toxicological relevance. - Macroscopic findings: Treatment-related yellowish discoloration of the gastro-intestinal mucosa was recorded in a number of rats of groups 3 and 4. Moreover, a few spontaneous gross lesions were encountered in both control and treated rats. These lesions were correlated with their histologic diagnoses. - Microscopic findings: A treatment-related minimal fine granular brownish pigmentation of proximal convoluted tubules was recorded in the kidneys of four males and five females of group 4 at the end of the administration period. Spurious pigmentation was still evident in the kidneys of five females at the end of the recovery period. Enhanced epithelial desquamation of the gastrointestinal mucosa was recorded in a few rats of group 4 which had been examined for macroscopic abnormalities. Moreover, a few spontaneous microscopic lesions were recorded at a random incidence in both control and treated rats. Effects were limited to the high dose group (1000 mg/kg bw) and included sedation in two male rats at day 8, increased liver weight and ratios in female rats, minimal pigmentation of proximal renal tubules and enhanced epithelial desquamation of the gastro-intestinal mucosa. Therefore, the NOAEL was determined to be 200 mg/kg/bw. The structurally related target substance will show similar behaviour and therefore it is anticipated that the NOAEL for systemic toxicity will be 200 mg/kg bw/d as well. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d5b8a08-85d5-414d-8486-16671c630fa2/documents/55616515-dd94-4a18-a1e3-3f0023080d26_4fa1d30a-ee58-4697-914a-38b01d0c718e.html,,,,,, "Trisodium 5-[[5-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl]azo]-1-ethyl-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-3-methanesulphonate",84045-63-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9d5b8a08-85d5-414d-8486-16671c630fa2/documents/55616515-dd94-4a18-a1e3-3f0023080d26_4fa1d30a-ee58-4697-914a-38b01d0c718e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "Trisodium 5-[[5-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl]azo]-1-ethyl-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-3-methanesulphonate",84045-63-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d5b8a08-85d5-414d-8486-16671c630fa2/documents/e6e2f884-10bf-4152-8bf2-f57b8887343f_4fa1d30a-ee58-4697-914a-38b01d0c718e.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium 5-[[5-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]amino]-2-sulphonatophenyl]azo]-1-ethyl-1,2-dihydro-6-hydroxy-4-methyl-2-oxopyridine-3-methanesulphonate",84045-63-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9d5b8a08-85d5-414d-8486-16671c630fa2/documents/e6e2f884-10bf-4152-8bf2-f57b8887343f_4fa1d30a-ee58-4697-914a-38b01d0c718e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Trisodium 5-[[5-methyl-4-[(4-nitro-2-sulphonatophenyl)azo]-2-(3-sulphonatopropoxy)phenyl]azo]salicylate,74186-17-7, There is one acute toxicity study available. After single oral administration no adverse effects were recorded at a dose of 2000 mg/kg bw in rats using the fixed dose method. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6250a146-cd0f-4373-855c-a14eb04eb979/documents/030222d5-d49a-4f8c-a248-c30a37e5e78e_5bbd634f-b71e-44ca-8086-1fce1a212458.html,,,,,, Trisodium 5-[[5-methyl-4-[(4-nitro-2-sulphonatophenyl)azo]-2-(3-sulphonatopropoxy)phenyl]azo]salicylate,74186-17-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6250a146-cd0f-4373-855c-a14eb04eb979/documents/030222d5-d49a-4f8c-a248-c30a37e5e78e_5bbd634f-b71e-44ca-8086-1fce1a212458.html,,oral,LD50,"2,500 mg/kg bw",no adverse effect observed, "Trisodium 7-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]methylamino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2-sulphonate",70210-21-8," Only one study of Acute Toxicity is available. This study meets National standarts method with acceptable restrictions. Klimish score 2. Acute Toxicity/Oral LD50=6,16 g/kg ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/492cfb08-b476-410d-8048-e29479f18c9a/documents/5d77a807-9be6-4f9b-8ceb-85b9f27fd205_8f43b33c-8b83-4034-a580-ed8f6f91271f.html,,,,,, "Trisodium 7-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]methylamino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2-sulphonate",70210-21-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/492cfb08-b476-410d-8048-e29479f18c9a/documents/5d77a807-9be6-4f9b-8ceb-85b9f27fd205_8f43b33c-8b83-4034-a580-ed8f6f91271f.html,,oral,LD50,"11,660 mg/kg bw",no adverse effect observed, "Trisodium 7-[[4-chloro-6-[ethyl[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate",83567-04-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e5890618-f63b-4ab9-9dd3-67acef9187bf/documents/01e9e20d-caf1-43aa-864e-3f788088cc00_595f67fd-6954-40b9-bef0-d49e97c62f43.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "Trisodium 7-[[4-chloro-6-[ethyl[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate",83567-04-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5890618-f63b-4ab9-9dd3-67acef9187bf/documents/8498c9c3-839d-4172-be1d-05f95f01cc52_595f67fd-6954-40b9-bef0-d49e97c62f43.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Trisodium 7-[[4-chloro-6-[ethyl[3-[[2-(sulphonatooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(4-methoxy-2-sulphonatophenyl)azo]naphthalene-2-sulphonate",83567-04-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e5890618-f63b-4ab9-9dd3-67acef9187bf/documents/8498c9c3-839d-4172-be1d-05f95f01cc52_595f67fd-6954-40b9-bef0-d49e97c62f43.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)",75234-41-2,"Groups of Sprague Dawley rats, comprising 5 animals of each sex, were treated at dose levels of 0 and 1000 mg/kg/day. All animals treated with 1000 mg/kg/day of the analogous substance, Brown HH 469, survived the 4 week study period. No treatment-related changes in clinical condition or behaviour occurred. Similar overall body weight gains were recorded in both test and control groups. Food consumption was similar in both groups. There were no changes in the haematological and clinical chemistry parameters measured. All organ weights and organ/body weight ratios were considered similar for treated and control animals. The gross and histological appearance of the skin site treated was similar to that of control animals. There was no evidence of any systemic toxicity in organs examined at necropsy or in tissues selected for histological evaluation.In conclusion, dermal application of the analogous substance at a dose level of 1000 mg/kg/day produced no evidence of systemic toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3e1b8b9-c56a-409d-a75c-17f907cb0592/documents/IUC5-3bd7f5d3-30a7-4175-ad54-489e69e501c7_77d1d54a-2f79-441f-b6b2-3c3ae5c38430.html,,,,,, "Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)",75234-41-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3e1b8b9-c56a-409d-a75c-17f907cb0592/documents/IUC5-3bd7f5d3-30a7-4175-ad54-489e69e501c7_77d1d54a-2f79-441f-b6b2-3c3ae5c38430.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)",75234-41-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3e1b8b9-c56a-409d-a75c-17f907cb0592/documents/IUC5-3bd7f5d3-30a7-4175-ad54-489e69e501c7_77d1d54a-2f79-441f-b6b2-3c3ae5c38430.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)",75234-41-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a3e1b8b9-c56a-409d-a75c-17f907cb0592/documents/IUC5-3bd7f5d3-30a7-4175-ad54-489e69e501c7_77d1d54a-2f79-441f-b6b2-3c3ae5c38430.html,Repeated dose toxicity – local effects,dermal,NOAEL,42 mg/cm2,no adverse effect observed,rat "Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)",75234-41-2,Oral gavage of 5000 mg/kg of the test material did not cause mortality in male and female rats. There were temporary clinical signs.The acute dermal median lethal dose (LD50) of the analogous substance in rats with intact skin was in excess of 2000 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3e1b8b9-c56a-409d-a75c-17f907cb0592/documents/IUC5-04113b33-872a-41b9-8877-284ccdad19c8_77d1d54a-2f79-441f-b6b2-3c3ae5c38430.html,,,,,, "Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)",75234-41-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3e1b8b9-c56a-409d-a75c-17f907cb0592/documents/IUC5-04113b33-872a-41b9-8877-284ccdad19c8_77d1d54a-2f79-441f-b6b2-3c3ae5c38430.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Trisodium bis[2-[[2,4-dihydroxy-3-[(2-methyl-4-sulphophenyl)azo]phenyl]azo]benzoato(3-)]chromate(3-)",75234-41-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3e1b8b9-c56a-409d-a75c-17f907cb0592/documents/IUC5-04113b33-872a-41b9-8877-284ccdad19c8_77d1d54a-2f79-441f-b6b2-3c3ae5c38430.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Trisodium bis[2-hydroxy-5-nitro-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonato(3-)]cobaltate(3-),85959-73-5," In the acute oral toxicity study, the LD50 was determined to be 1666 mg/kg bw for male/female. Based on the criteria in the Regulation CE n.1272/2008, the tested substance needs to be classified as Acute Tox. Cat. 4. No study available for dermal and inhalation toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fd4750e-793d-41b3-b04d-a440edc639a3/documents/0d214a2c-7cf9-4f48-886d-7e6e746f6b6c_4fc201e5-ef07-46ce-a5a1-b955d517c4a5.html,,,,,, Trisodium bis[2-hydroxy-5-nitro-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]benzenesulphonato(3-)]cobaltate(3-),85959-73-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9fd4750e-793d-41b3-b04d-a440edc639a3/documents/0d214a2c-7cf9-4f48-886d-7e6e746f6b6c_4fc201e5-ef07-46ce-a5a1-b955d517c4a5.html,,oral,LD50,"1,666 mg/kg bw",adverse effect observed, "Trisodium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]chromate(3-)",55809-98-8, LD50 > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10e4dafb-12c4-45ad-9d03-ae5d5556dea2/documents/IUC5-5879929b-c11f-42de-a9d1-1ff8685eb72a_91efd28c-2a94-49b8-b22b-a82911626ece.html,,,,,, "Trisodium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]chromate(3-)",55809-98-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/10e4dafb-12c4-45ad-9d03-ae5d5556dea2/documents/IUC5-5879929b-c11f-42de-a9d1-1ff8685eb72a_91efd28c-2a94-49b8-b22b-a82911626ece.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Trisodium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]cobaltate(3-)",84204-70-6, LD0 male/female (5 d): >= 1000 mg/Kg bw ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/db52b799-56ee-4734-bd19-273f518422ec/documents/e5fd5a1e-a07a-4db9-8931-cf564aa11ad2_79a4c9d8-1b0f-4921-ae8f-c55472f12ee1.html,,,,,, "Trisodium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]cobaltate(3-)",84204-70-6,Acute oral toxicity: LD50 male/female: 2717 mg/Kg bwAcute dermal toxicity: LD50 male/female: > 2000 mg/Kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db52b799-56ee-4734-bd19-273f518422ec/documents/IUC5-77997880-c155-41fe-b014-38edf7401152_79a4c9d8-1b0f-4921-ae8f-c55472f12ee1.html,,,,,, "Trisodium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]cobaltate(3-)",84204-70-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db52b799-56ee-4734-bd19-273f518422ec/documents/IUC5-77997880-c155-41fe-b014-38edf7401152_79a4c9d8-1b0f-4921-ae8f-c55472f12ee1.html,,oral,LD50,"2,717 mg/kg bw",no adverse effect observed, "Trisodium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulphonato(3-)]cobaltate(3-)",84204-70-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/db52b799-56ee-4734-bd19-273f518422ec/documents/IUC5-77997880-c155-41fe-b014-38edf7401152_79a4c9d8-1b0f-4921-ae8f-c55472f12ee1.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxy-5-nitrobenzenesulphonato(3-)]chromate(3-)",57674-14-3, Oral rat LD50: 7000 mg/kg bw Dermal rat LD50: 2500 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd21c571-44f8-42e0-865d-3fbf1e22ff05/documents/IUC5-b58634a6-d7df-47d7-bd05-6f1cfadb7aaf_2f8d0c33-2a6f-451f-8f27-0e732a125e83.html,,,,,, "Trisodium bis[3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxy-5-nitrobenzenesulphonato(3-)]chromate(3-)",57674-14-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd21c571-44f8-42e0-865d-3fbf1e22ff05/documents/IUC5-b58634a6-d7df-47d7-bd05-6f1cfadb7aaf_2f8d0c33-2a6f-451f-8f27-0e732a125e83.html,,oral,LD50,"7,000 mg/kg bw",no adverse effect observed, Trisodium bis[3-[[1-(anilinocarbonyl)-2-oxopropyl]azo]-5-chloro-2-hydroxybenzenesulphonato(3-)]cobaltate(3-),73324-01-3, LD50(oral) > 10000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05bd585d-d5d8-4c56-9b74-31b73c34bfdd/documents/bf3ece15-8e27-4a41-acf6-c43d8385b657_06976b6c-7c13-4d00-9580-a83d1410dc52.html,,,,,, Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-),57693-14-8," In a study according to OECD guideline 422, no adverse effects at all were observed in parental as well as in offspring animals. The NOAEL regarding systemic toxicity was 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfb9595a-f852-4d73-ab8a-7848ce5a54e2/documents/4a67288d-c7c3-4a08-868f-12a897e5d697_fbadb804-e340-4c8e-9629-4e65aa68033e.html,,,,,, Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-),57693-14-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bfb9595a-f852-4d73-ab8a-7848ce5a54e2/documents/4a67288d-c7c3-4a08-868f-12a897e5d697_fbadb804-e340-4c8e-9629-4e65aa68033e.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-),57693-14-8, After oral as well as dermal acute exposure the lethal doses were above 2000 mg/kg bw in all studies. Minor adverse effects occurred only after high oral doses. No inhalation toxicity study is available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfb9595a-f852-4d73-ab8a-7848ce5a54e2/documents/ce0c2f3b-76f8-468a-aebe-76a7a4307708_fbadb804-e340-4c8e-9629-4e65aa68033e.html,,,,,, Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-),57693-14-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfb9595a-f852-4d73-ab8a-7848ce5a54e2/documents/ce0c2f3b-76f8-468a-aebe-76a7a4307708_fbadb804-e340-4c8e-9629-4e65aa68033e.html,,oral,LD50,"2,000 mg/kg bw",adverse effect observed, Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(3-),57693-14-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bfb9595a-f852-4d73-ab8a-7848ce5a54e2/documents/ce0c2f3b-76f8-468a-aebe-76a7a4307708_fbadb804-e340-4c8e-9629-4e65aa68033e.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Trisodium bis[3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]naphthalene-1-sulphonato(3-)]chromate(3-),75214-58-3, LD50 (male and female) > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/78b6c36f-56b4-40c9-905f-0b740875d39b/documents/121af243-355a-40cd-8e77-54baa6978f15_572db179-483b-4dcc-9f5b-ff880544fa5b.html,,,,,, "Trisodium bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromate(3-)",61916-41-4,Oral LD50 rat > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53279078-b29f-4faf-9660-2da5b1e6eca1/documents/IUC5-466446f8-dd7a-444b-ac4c-92d00cbfdbc2_c0ac996d-c3c6-4132-970b-711fb8bbd33f.html,,,,,, "Trisodium bis[4-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-3-hydroxynaphthalene-1-sulphonato(3-)]chromate(3-)",61916-41-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/53279078-b29f-4faf-9660-2da5b1e6eca1/documents/IUC5-466446f8-dd7a-444b-ac4c-92d00cbfdbc2_c0ac996d-c3c6-4132-970b-711fb8bbd33f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium bis[4-[4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzene-1-sulphonato(3-)]cobaltate(3-)",79135-28-7, Oral LD50 > 5000 mg/kg bw Dermal LD50 > 5000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f1fa044-fd2b-47e3-bde2-6d093dee85ce/documents/462b7515-3e0a-4d6d-95b7-04f92f7102e1_0394c72c-20bd-473b-8ab4-1b1adcbf4509.html,,,,,, "Trisodium bis[4-[4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzene-1-sulphonato(3-)]cobaltate(3-)",79135-28-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f1fa044-fd2b-47e3-bde2-6d093dee85ce/documents/462b7515-3e0a-4d6d-95b7-04f92f7102e1_0394c72c-20bd-473b-8ab4-1b1adcbf4509.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Trisodium bis[4-[4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzene-1-sulphonato(3-)]cobaltate(3-)",79135-28-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3f1fa044-fd2b-47e3-bde2-6d093dee85ce/documents/462b7515-3e0a-4d6d-95b7-04f92f7102e1_0394c72c-20bd-473b-8ab4-1b1adcbf4509.html,,dermal,LD50,"5,000 mg/kg bw",no adverse effect observed, "Trisodium bis[4-[4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzene-1-sulphonato(3-)]ferrate(3-)",72479-30-2,"Acute administration by oral route, LD50= 16000 mg/kg b.wAcute administration by dermal route, LD0 > 5000 mg/kg b.w ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d2c23cda-2ca5-4474-8d01-24f8b8540a5d/documents/IUC5-d6114963-e5de-4df4-8d80-48b4d6315213_f7c1b362-7149-42f7-96f1-ee9e87dbd097.html,,,,,, "Trisodium dihydrogen -N,N-[bis[2-[bis(carboxylatomethyl)amino]ethyl]]glycinate",13078-36-9,"  Using a read-across extrapolation approach from a GLP, OECD 407 guideline study on the structural analogue DTPA pentasodiuum salt, the sub-acute NOAEL of DTPA trisodium salt in rats is predicted to be circa 75mg/kg bw/day or above (taking into account stoichiometric considerations). The two substances are structurally similar and have the same metal ion, chelating mode of action. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/578aec8d-a160-4121-a286-05e46f63df17/documents/f60565c4-4378-4f1a-a9df-1cb7134d8785_0643acd4-390d-4ffd-b42a-301defef712d.html,,,,,, "Trisodium dihydrogen -N,N-[bis[2-[bis(carboxylatomethyl)amino]ethyl]]glycinate",13078-36-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/578aec8d-a160-4121-a286-05e46f63df17/documents/f60565c4-4378-4f1a-a9df-1cb7134d8785_0643acd4-390d-4ffd-b42a-301defef712d.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat "Trisodium dihydrogen -N,N-[bis[2-[bis(carboxylatomethyl)amino]ethyl]]glycinate",13078-36-9," Using a read-across extrapolation approach from OECD 401 and 402 guideline limit studies on the structural analogue DTPA pentapotassium salt, DTPA trisodium salt is predicted to be of low acute oral and dermal toxicity with LD50 values in excess of 2,000 mg/kg.bw. The two substances are structurally similar and have the same metal ion, chelating mode of action. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/578aec8d-a160-4121-a286-05e46f63df17/documents/7d78a055-51e4-4393-8d20-32a4667f6352_0643acd4-390d-4ffd-b42a-301defef712d.html,,,,,, "Trisodium dihydrogen -N,N-[bis[2-[bis(carboxylatomethyl)amino]ethyl]]glycinate",13078-36-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/578aec8d-a160-4121-a286-05e46f63df17/documents/7d78a055-51e4-4393-8d20-32a4667f6352_0643acd4-390d-4ffd-b42a-301defef712d.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Trisodium dihydrogen -N,N-[bis[2-[bis(carboxylatomethyl)amino]ethyl]]glycinate",13078-36-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/578aec8d-a160-4121-a286-05e46f63df17/documents/7d78a055-51e4-4393-8d20-32a4667f6352_0643acd4-390d-4ffd-b42a-301defef712d.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-)",84057-71-6," Acute oral toxicity: Data available for the structurally and functionally similar read across chemicals has been reviewed to determine the acute oral toxicity of the test chemical Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS no.: 84057-71-6). The studies are as mentioned below: WoE 2: Acute oral toxicity study was conducted in rats using test material at the concentration of 7460 mg/kg bw. 50% mortality was observed at dose 7460 mg/kg bw. Hence, LD50 value was considered to be 7460 mg/kg bw, when rats were treated with test chemical via oral route. WoE 3: Acute oral toxicity study was conducted in rats using test material at the dose concentration of 8980 mg/kg bw. 50% mortality was observed at dose 8980 mg/kg bw. Hence, LD50 value was considered to be 8980 mg/kg bw, when rats were treated with test chemical via oral route. Thus, based on the above summarised studies, Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS no.: 84057-71-6) and it’s structurally and functionally similar read across substances, it can be concluded that LD50 value is >2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) (CAS no.: 84057-71-6) cannot be classified for acute oral toxicity. Hence, Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl] phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-) is not toxic for acute oral toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec481672-6493-44aa-9321-9c18c0f9019e/documents/ce0072b2-b876-4a72-b2bb-1eaaab55e044_c502cc82-9df1-4291-99a8-51f1718171ae.html,,,,,, "Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[3-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-)",84057-71-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec481672-6493-44aa-9321-9c18c0f9019e/documents/ce0072b2-b876-4a72-b2bb-1eaaab55e044_c502cc82-9df1-4291-99a8-51f1718171ae.html,,oral,LD50,"8,980 mg/kg bw",no adverse effect observed, "Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-)",86024-59-1,Oral LD50 (rat) (males/females) > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec923f69-6222-49db-98ef-4ff1dd9303e6/documents/IUC5-af9a1ddb-3db8-48fb-9bfa-fa26c8f738a7_6df2d7ac-8d20-41c9-8e25-26cd5353831c.html,,,,,, "Trisodium hydrogen [2-[[α-[[3-[[4-chloro-6-[ethyl[4-[[2-(sulphooxy)ethyl]sulphonyl]phenyl]amino]-1,3,5-triazin-2-yl]amino]-2-hydroxy-5-sulphophenyl]azo]benzyl]azo]-4-sulphobenzoato(6-)]cuprate(4-)",86024-59-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ec923f69-6222-49db-98ef-4ff1dd9303e6/documents/IUC5-af9a1ddb-3db8-48fb-9bfa-fa26c8f738a7_6df2d7ac-8d20-41c9-8e25-26cd5353831c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Trisodium hydrogen diphosphate,14691-80-6," One key study is available on an analogous substance (Seo D, 2011) for the sub-chronic toxicity endpoint. This study is considered to be a reliability 2 study as it has been conducted to the appropriate guideline (OECD 408) and under the conditions of GLP. On the basis of this study the NOAEL was determined to be 500 mg/kg bw/day. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9afef87-f0a4-4080-a091-33d63d74b553/documents/IUC5-40858c78-6ebe-4c2a-a2cc-02e693cf0b9b_1aeb81de-6c8d-4b1c-baa1-5f24bda0e2a4.html,,,,,, Trisodium hydrogen diphosphate,14691-80-6,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/e9afef87-f0a4-4080-a091-33d63d74b553/documents/IUC5-40858c78-6ebe-4c2a-a2cc-02e693cf0b9b_1aeb81de-6c8d-4b1c-baa1-5f24bda0e2a4.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Trisodium hydrogen diphosphate,14691-80-6," Acute oral toxicity: One key study is available. The study is performed in accordance with OECD TG 420 and under the conditions of GLP. No dose descriptor is assigned as the LD50 was determined to be in the range of > 300 < 2000 mg/kg bw. Acute inhalation toxicity: One key study is available. The study was performed on an analogous substance and in accordance an appropriate guideline and under the conditions of GLP. No dose descriptor is assigned as the LC50 was determined to be a greater than value. Acute dermal toxicity: One key study is available. The study was performed on an analogous substance and in accordance with OECD TG 402 and under the conditions of GLP. No dose descriptor is assigned as the LD50 was determined to be a greater than value (>2,000 mg/kg bw). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e9afef87-f0a4-4080-a091-33d63d74b553/documents/IUC5-4baa54e0-b952-473b-811d-c0d0b638aee5_1aeb81de-6c8d-4b1c-baa1-5f24bda0e2a4.html,,,,,, "Trisodium trihydrogen 5,5',5''-(1,3,5-triazine-2,4,6-triyltriimino)tris[5-sulphonatosalicylate]",79135-90-3, In an oral study in rats the acute LD50 was above 5000 mg/kg bw. No mortality occurred. No further studies available. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8517ad30-2c27-4ebb-97aa-ec8c8d06d70d/documents/a4a0f025-6043-402e-952b-882659351d2c_393fa8ad-6ef5-4c1d-8b00-f13d1d35cd57.html,,,,,, "Trisodium trihydrogen 5,5',5''-(1,3,5-triazine-2,4,6-triyltriimino)tris[5-sulphonatosalicylate]",79135-90-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8517ad30-2c27-4ebb-97aa-ec8c8d06d70d/documents/a4a0f025-6043-402e-952b-882659351d2c_393fa8ad-6ef5-4c1d-8b00-f13d1d35cd57.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Trizinc bis(hexacyanidocobaltate(III)) dodecahydrate,69207-66-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5663cd95-84c5-4481-b69b-e7808972cd72/documents/IUC5-e1ef7700-4d73-4c95-9d7f-5373ed947ddf_546fe85c-8558-4ff6-8fb6-948ef33ea6ee.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Trizinc bis(orthophosphate),7779-90-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/18044a99-8ac3-49d1-ae56-2cccdb6b67d5/documents/d3dbfe8d-29df-4047-bae7-35d291fdb315_511d7693-9c55-43c3-b1ae-f9811690bcf9.html,Repeated dose toxicity – local effects,inhalation,BMCL10,0.971 mg/m3,adverse effect observed,rat Trizinc bis(orthophosphate),7779-90-0,Acute oral toxicity: key study carried out according to OECD guideline no 401 indicating for trizinc bis(orthophosphate) LD50 > 5000 mg/kg bw   Acute inhalation toxicity: key study carried out according to OECD guideline no 403 indicating for zinc oxide LC50 > 5.7 mg/L/4hrs (read-across to trizinc bis(orthophosphate)   ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18044a99-8ac3-49d1-ae56-2cccdb6b67d5/documents/IUC5-352cbdc0-3e47-4b3b-b4cb-f994c783b43f_511d7693-9c55-43c3-b1ae-f9811690bcf9.html,,,,,, Trizinc bis(orthophosphate),7779-90-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18044a99-8ac3-49d1-ae56-2cccdb6b67d5/documents/IUC5-352cbdc0-3e47-4b3b-b4cb-f994c783b43f_511d7693-9c55-43c3-b1ae-f9811690bcf9.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Trizinc bis(orthophosphate),7779-90-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/18044a99-8ac3-49d1-ae56-2cccdb6b67d5/documents/IUC5-352cbdc0-3e47-4b3b-b4cb-f994c783b43f_511d7693-9c55-43c3-b1ae-f9811690bcf9.html,,inhalation,LC50,"5,700 mg/m3",no adverse effect observed, Troclosene sodium,2893-78-9," 28 day extended to 59 day study drinking water study (rat). Mortalities at mid and high dose levels. High: decreased urine volume and urine creatine in males, decreased absolute liver weight. Effects considered due to aversion to drinking water due to high chlorine concentration. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/184033d4-a128-4902-9608-142b299da991/documents/IUC5-a9133e7f-ebe2-4ce3-b19e-ab197a3df9be_718b46ab-7bc4-4f69-9faa-6acbeb91322d.html,,,,,, Troclosene sodium,2893-78-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/184033d4-a128-4902-9608-142b299da991/documents/IUC5-a9133e7f-ebe2-4ce3-b19e-ab197a3df9be_718b46ab-7bc4-4f69-9faa-6acbeb91322d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,115 mg/kg bw/day,,rat Troclosene sodium,2893-78-9," Acute toxicity studies are available for the oral, dermal and inhalation routes. Troclosene sodium is considered harmful via the oral route but not via the dermal or inhalation route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/184033d4-a128-4902-9608-142b299da991/documents/IUC5-e5cf13ee-7e7f-4cd0-9c55-84fc798c1bed_718b46ab-7bc4-4f69-9faa-6acbeb91322d.html,,,,,, Troclosene sodium,2893-78-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/184033d4-a128-4902-9608-142b299da991/documents/IUC5-e5cf13ee-7e7f-4cd0-9c55-84fc798c1bed_718b46ab-7bc4-4f69-9faa-6acbeb91322d.html,,oral,LD50,"1,671 mg/kg bw",adverse effect observed, Troclosene sodium,2893-78-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/184033d4-a128-4902-9608-142b299da991/documents/IUC5-e5cf13ee-7e7f-4cd0-9c55-84fc798c1bed_718b46ab-7bc4-4f69-9faa-6acbeb91322d.html,,inhalation,LC50,270 mg/m3,adverse effect observed, Tungsten,7440-33-7," Repeated Dose Toxicity - Oral Route: No oral repeated dose toxicity data of sufficient quality are available for tungsten metal (target substance). However, repeated oral dose toxicity data are available for sodium tungstate (source substance), which are used for read-across. Due to lower water solubility and lower toxicity for the target substance compared to the source substance, the resulting read-across from the source substance to the target substance is appropriate as a conservative estimate of potential toxicity for this endpoint. In addition, read-across is appropriate because the classification and labelling is more protective for the source substance than the target substance, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, lower for the source substance. For more details, refer to the read-across category approach included in the Category section of this IUCLID submission or Annex 3 in the CSR. The read-across study on sodium tungstate was sponsored conducted the United States Army Center for Health Promotion and Preventive Medicine and published by McCain et al (2015). The 90-day oral toxicity study was conducted in rats according to the procedure described in the Environmental Protection Agency (EPA) Health Effects Testing Guidelines (40 CFR, Part 798.2650) in compliance with Good Laboratory Practice. Briefly, this study of the subchronic toxicity of sodium tungstate dihydrate aqueous solution in male and female Sprague-Dawley rats was evaluated by daily oral gavage of 0, 10, 75, 125 or 200 mg/kg bw/d for 90 days. Measured parameters included food consumption, body weight measurements, hematology, clinical chemistry, and histopathological changes. There was a significant decrease in food consumption and body weight gain in males at 200 mg/kg bw/d from days 77 to 90; however, there was no effect in food consumption and body weights in females. There were no changes in the hematological and clinical parameters studied. Histopathological changes were seen in kidney of male and female and epididymis of male rats. The histopathological changes observed in the kidneys of male and female rats dosed at 125 or 200 mg/k/d consisting of mild to severe cortical tubule basophilia in 2 high-dose groups. Histological changes in epididymides included intraluminal hypospermia with cell debris in the 200 mg/kg bw/day dosed male rats. Histopathological changes were observed in the glandular stomach including inflammation and metaplasia in the high-dose groups (125 or 200 mg/kg bw/day) of both sexes of rats. Based on histopathology effects seen in the kidneys, the lowest observable adverse effect level was 125 mg/kg bw/d and the no observable adverse effect level was 75 mg/kg bw/d in both sexes of rats for oral subchronic toxicity. The USEPA’s Benchmark Dose Software (BMDS, Version 1.4.1) was used to model the data to derive a BMDL10. The lowest (most precautionary) BMDL10 from the renal toxicity endpoint in the 90-day oral toxicity study was 102 mg/kg bw/d. In addition to McCain et al (2015) rat oral 90-day repeated dose study, the US National Toxicology Program (NTP) has conducted two additional 90-day drinking water studies, one in Sprague-Dawley rats and a second one in B6C3F1 mice (10/sex/species/dose). The study design included doses of0, 125, 250, 500, 1000, or 2000 mg/L. The in-life study phase has been completed but no study report has yet been issued. Currently, available in the US NTP website are graphs and Tables are preliminary results, but no full report has been issued. Furthermore, at the 2012 Annual Meeting of the Society of Toxicology, a Scientific Poster was presented detailing preliminary results of the NTP study. Preliminary results confirm the results of the McCain gavage study, showing the kidney as the major target organ for tungstate (especially at high drinking water doses of 1,000 and 2,000 mg/L). The US NTP Study final reports of sodium tungstate could be available by 2022.   Repeated Dose Toxicity - Inhalation Route: No repeated dose inhalation toxicity data of sufficient quality are available for tungsten metal (target substance). However, repeated dose inhalation toxicity data are available for tungsten oxide (source substance). Due to higher water solubility and greater in vitro bioaccessibility in synthetic alveolar, lysosomal, and interstitial fluids simulating inhalation exposure for the source substance as compared to the target substance and lack of toxicity from acute toxicity studies for the target and source substances, toxicity data on the source substance is expected to represent a worse case, so read-across is appropriate between these substances. In addition, read-across is appropriate for this endpoint because the classification and labelling for human health toxicity endpoints is the same for the source and target substances, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, sufficiently similar or lower for the source substance. For more details, refer to the read-across category approach in the Category section of this IUCLID or Annex 3 in the CSR. A 28-day inhalation toxicity study conducted according to OECD 412 is available on tungsten oxide, which is considered the key repeated dose study. In this study, 5 rats/sex/dose were given tungsten oxide nose-only for 6 hours per day, 7 days/week, for 28 days (with a 14-day recovery period) at doses of 0 (control), 0.08, 0.325 and 0.65 mg/L air. The NOAEC was deemed to be > 0.65 mg/L air (650 mg/m3), as no significant effects were reported. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a39dfb1-3c25-4adb-a0f4-402c8f9c516d/documents/ea5d05bd-e597-4843-9a0e-0f1c2acc88b5_ccfc89c9-ec96-4c19-84a5-6aa6205eafa3.html,,,,,, Tungsten,7440-33-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a39dfb1-3c25-4adb-a0f4-402c8f9c516d/documents/ea5d05bd-e597-4843-9a0e-0f1c2acc88b5_ccfc89c9-ec96-4c19-84a5-6aa6205eafa3.html,Sub-chronic toxicity – systemic effects,oral,BMDL10,102 mg/kg bw/day,,rat Tungsten,7440-33-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6a39dfb1-3c25-4adb-a0f4-402c8f9c516d/documents/ea5d05bd-e597-4843-9a0e-0f1c2acc88b5_ccfc89c9-ec96-4c19-84a5-6aa6205eafa3.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,650 mg/m3,,rat Tungsten,7440-33-7," Acute toxicity studies of sufficient quality and tested in accordance with standard methodology showed that the acute oral LD50 was > 2000 mg/kg in rats, the acute dermal LD50 was >2000 mg/kg, and the acute inhalation LC50 was > 5.4 mg/L/4h for tungsten metal. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a39dfb1-3c25-4adb-a0f4-402c8f9c516d/documents/a2afb163-2d2c-4056-a448-85232a6387ba_ccfc89c9-ec96-4c19-84a5-6aa6205eafa3.html,,,,,, Tungsten,7440-33-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a39dfb1-3c25-4adb-a0f4-402c8f9c516d/documents/a2afb163-2d2c-4056-a448-85232a6387ba_ccfc89c9-ec96-4c19-84a5-6aa6205eafa3.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tungsten,7440-33-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a39dfb1-3c25-4adb-a0f4-402c8f9c516d/documents/a2afb163-2d2c-4056-a448-85232a6387ba_ccfc89c9-ec96-4c19-84a5-6aa6205eafa3.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tungsten,7440-33-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6a39dfb1-3c25-4adb-a0f4-402c8f9c516d/documents/a2afb163-2d2c-4056-a448-85232a6387ba_ccfc89c9-ec96-4c19-84a5-6aa6205eafa3.html,,inhalation,LC50,"5,400 mg/m3",no adverse effect observed, Tungsten carbide,12070-12-1,"Repeated Dose Toxicity - Oral Route: No oral repeated dose toxicity data of sufficient quality are available for tungsten carbide (target substance). However, repeated oral dose toxicity data are available for sodium tungstate (source substance), which are used for read-across. Due to lower water solubility and lower toxicity for the target substance compared to the source substance, the resulting read-across from the source substance to the target substance is appropriate as a conservative estimate of potential toxicity for this endpoint. In addition, read-across is appropriate because the classification and labelling is more protective for the source substance than the target substance, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, lower for the source substance. For more details, refer to the read-across category approach included in the Category section of this IUCLID submission on Annex 3 in the CSR. The read-across study on sodium tungstate was sponsored conducted the United States Army Center for Health Promotion and Preventive Medicine and published byMcCain et al (2015). The 90-day oral toxicity study was conducted in rats according to the procedure described in the Environmental Protection Agency (EPA) Health Effects Testing Guidelines (40 CFR, Part 798.2650) in compliance with Good Laboratory Practice. Briefly, this study of the subchronic toxicity of sodium tungstate dihydrate aqueous solution in male and female Sprague-Dawley rats was evaluated by daily oral gavage of 0, 10, 75, 125, or 200 mg/kg bw/d for 90 days. Measured parameters included food consumption, body weight measurements, hematology, clinical chemistry, and histopathological changes. There was a significant decrease in food consumption and body weight gain in males at 200 mg/kg bw/d from days 77 to 90; however, there was no effect in food consumption and body weights in females. There were no changes in the hematological and clinical parameters studied. Histopathological changes were seen in kidney of male and female and epididymis of male rats. The histopathological changes observed in the kidneys of male and female rats dosed at 125 or 200 mg/k/d consisting of mild to severe cortical tubule basophilia in 2 high-dose groups. Histological changes in epididymides included intraluminal hypospermia with cell debris in the 200 mg/kg bw/day dosed male rats. Histopathological changes were observed in the glandular stomach including inflammation and metaplasia in the high-dose groups (125 or 200 mg/kg bw/day) of both sexes of rats. Based on histopathology effects seen in the kidneys, the lowest observable adverse effect level was 125 mg/kg bw/d and the no observable adverse effect level was 75 mg/kg bw/d in both sexes of rats for oral subchronic toxicity. The US EPA’s Benchmark Dose Software (BMDS, Version 1.4.1) was used to model the data to derive a BMDL10. The lowest (most precautionary) BMDL10 from the renal toxicity endpoint in the 90-day oral toxicity study was 102 mg/kg bw/d. In addition to McCain et al (2015) rat oral 90-day repeated dose study, the US National Toxicology Program (NTP) has conducted two additional 90-day drinking water studies, one in Sprague-Dawley rats and a second one in B6C3F1 mice (10/sex/species/dose). The study design included doses of 0, 125, 250, 500, 1000, or 2000 mg/L.  There were no early deaths during the 3-month rat study. When compared to the vehicle control group, final mean body weights were lower for the 1,000 and 2,000 mg/L males and 2,000 mg/L females. Water consumption was lower for the 1,000 and 2,000 mg/L males and females. The urine xanthine/creatinine ratios were significantly increased in all male and female exposed groups. Serum insulin concentrations were significantly decreased in the 2,000 mg/L males relative to the vehicle control males. Significantly decreased absolute weights were observed in several organs but were considered secondary to body weights reductions. Exposure-related histological lesions were limited to the kidneys and included increased incidences of renal tubule regeneration in the 1,000 and 2,000 mg/L males and females; the increases in the 2,000 mg/L groups were significant relative to the vehicle control group. In the mice study, a decreased water consumption was observed in 1000 (11%) and 2000 mg/L (16%) male mice. During the 13-week phase of the study, there was no effect on survival, hematology, or organ weights in mice. Renal tubule regeneration was characterized by hyperplasia of tubular epithelial cells with cytoplasmic basophilia, nuclear crowding, karyomegaly, and occasional mitotic figures. Total tungsten concentrations were generally dose proportional in blood and urine. The micronucleus assay was negative in mice. The Comet assay was positive in the liver and ileum of male mice and negative in the blood and kidney of mice. The kidney appeared to be the only major target organ following exposure of mice to sodium tungstate dihydrate at water concentrations of 1000 and 2000 mg/L. Repeated Dose Toxicity - Inhalation Route: A 90-day repeat dose inhalation toxicity study was identified for tungsten carbide (WC) in which one dose of WC (15 mg/m3) was administered to rats and mice, whole body inhalation exposure, 5 days/week for 13 weeks. The LOEL was deemed to be 15 mg/m3in rats based on mild histopathological alterations in the lungs (focal reactions around the end airways) and chronic rhinitis, and in mice based on chronic rhinitis. However, because only one dose was evaluated, this dose did not result in any effects on which a DNEL would be derived or classification would be based, and using this dose would result in an inaccurate DNEL and classification, the 28-day inhalation toxicity study on tungsten oxide are used for read-across. No inhalation repeated dose toxicity data of sufficient quality are available for tungsten carbide however, data are available for tungsten oxide, which are used for read-across. No inhalation repated dose toxicity data of sufficient quality are available for tungsten carbide (target substance). However, inhalation repeated dose toxicity data are available for tungsten oxide (source substance), which are used for read-across. Due to lower water solubility and similar toxicity for the target substance compared to the source substance, the resulting read-across from the source substance to the target substance is appropriate. In addition, rea- across is appropriate because the classification and labelling is similar for the source substance than the target substance, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, lower for the source substance. For more details, refer to the read-across category approach in Annex 3 in the CSR. A 28-day inhalation toxicity study conducted according to OECD 412 is available on tungsten oxide (also known as tungsten blue oxide or TBO), which is considered the key repeated dose study. In this study, 5 rats/sex/dose were given TBO nose-only for 6 hours per day, 7 days/week, for 28 days (with a 14-day recovery period) at doses of 0 (control), 0.08, 0.325, and 0.65 mg/L air. The NOAEC was deemed to be > 0.65 mg/L air (650 mg/m3), as no significant effects were reported. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The reliability of this study for the substance tested is a K1, but in application of read-across to a different substance ECHA’s guidance specifies that the score can be a maximum of K2. Due to higher water solubility and greater in vitro bioaccessibility in synthetic alveolar, lysosomal, and interstitial fluids simulating inhalation exposure for the source substance, tungsten oxide (aka tungsten blue oxide, or TBO) as compared to the target substance (tungsten metal) and lack of toxicity from acute toxicity studies for the target and source substances, toxicity data on the target substance is expected to represent a worse case, so read-across is appropriate between these substances. In addition, read-across is appropriate for this endpoint because the classification and labelling for human health toxicity endpoints is the same for the source and target substances, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, sufficiently similar or more conservative for the target substance. For more details, refer to the attached description of the read-across category approach. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): The reliability of this study for the substance tested is a K1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b559928d-ea7c-4331-a8b4-5262011ccc1b/documents/2277a01a-32bf-4c89-b1fb-b8a9df762926_8adae31d-a2f8-445b-9210-1cc97e7dae01.html,,,,,, Tungsten carbide,12070-12-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b559928d-ea7c-4331-a8b4-5262011ccc1b/documents/2277a01a-32bf-4c89-b1fb-b8a9df762926_8adae31d-a2f8-445b-9210-1cc97e7dae01.html,Sub-chronic toxicity – systemic effects,oral,BMDL10,102 mg/kg bw/day,,rat Tungsten carbide,12070-12-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b559928d-ea7c-4331-a8b4-5262011ccc1b/documents/2277a01a-32bf-4c89-b1fb-b8a9df762926_8adae31d-a2f8-445b-9210-1cc97e7dae01.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,650 mg/m3,,rat Tungsten carbide,12070-12-1," Acute toxicity studies of sufficient quality and tested in accordance with standard methodology on tungsten carbide indicate a low potential for acute toxicity when administered through oral, inhalation, or dermal routes. No histopathological effects were reported, and the LD50s/LC50s and NOELs reported in each study were greater than the highest dose tested, > 2000 mg/kg bw, > 5.3 mg/L/4hrs, and > 2000 mg/kg bw for the oral, inhalation, and dermal routes of administration, respectively. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b559928d-ea7c-4331-a8b4-5262011ccc1b/documents/IUC5-d719a5d9-1f18-46e7-9132-78dc8c1f6f49_8adae31d-a2f8-445b-9210-1cc97e7dae01.html,,,,,, Tungsten carbide,12070-12-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b559928d-ea7c-4331-a8b4-5262011ccc1b/documents/IUC5-d719a5d9-1f18-46e7-9132-78dc8c1f6f49_8adae31d-a2f8-445b-9210-1cc97e7dae01.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tungsten carbide,12070-12-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b559928d-ea7c-4331-a8b4-5262011ccc1b/documents/IUC5-d719a5d9-1f18-46e7-9132-78dc8c1f6f49_8adae31d-a2f8-445b-9210-1cc97e7dae01.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tungsten carbide,12070-12-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b559928d-ea7c-4331-a8b4-5262011ccc1b/documents/IUC5-d719a5d9-1f18-46e7-9132-78dc8c1f6f49_8adae31d-a2f8-445b-9210-1cc97e7dae01.html,,inhalation,LC50,"5,300 mg/m3",no adverse effect observed, Tungsten dioxide,12036-22-5," Repeated Dose Toxicity - Oral Route: No oral repeated dose toxicity data of sufficient quality are available for tungsten dioxide (target substance). However, repeated oral dose toxicity data are available for sodium tungstate (source substance), which will be used for read-across. Due to lower water solubility and lower toxicity for the target substance compared to the source substance, the resulting read-across from the source substance to the target substance is appropriate as a conservative estimate of potential toxicity for this endpoint. In addition, read-across is appropriate because the classification and labelling is more protective for the source substance than the target substance, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, lower for the source substance. For more details, refer to the read-across category approach included in the Category section of this IUCLID submission and/or as an Annex in the CSR. The read-across study on sodium tungstate was sponsored conducted the United States Army Center for Health Promotion and Preventive Medicine and published byMcCain et al (2015). The 90-day oral toxicity study was conducted in rats according to the procedure described in the Environmental Protection Agency (EPA) Health Effects Testing Guidelines (40 CFR, Part 798.2650) in compliance with Good Laboratory Practice. Briefly, this study of the subchronic toxicity of sodium tungstate dihydrate aqueous solution in male and female Sprague-Dawley rats was evaluated by daily oral gavage of 0, 10, 75, 125, or 200 mg/kg bw/d for 90 days. Measured parameters included food consumption, body weight measurements, hematology, clinical chemistry, and histopathological changes. There was a significant decrease in food consumption and body weight gain in males at 200 mg/kg bw/d from days 77 to 90; however, there was no effect in food consumption and body weights in females. There were no changes in the hematological and clinical parameters studied. Histopathological changes were seen in kidney of male and female and epididymis of male rats. The histopathological changes observed in the kidneys of male and female rats dosed at 125 or 200 mg/k/d consisting of mild to severe cortical tubule basophilia in 2 high-dose groups. Histological changes in epididymides included intraluminal hypospermia with cell debris in the 200 mg/kg bw/day dosed male rats. Histopathological changes were observed in the glandular stomach including inflammation and metaplasia in the high-dose groups (125 or 200 mg/kg bw/day) of both sexes of rats. Based on histopathology effects seen in the kidneys, the lowest observable adverse effect level was 125 mg/kg bw/d and the no observable adverse effect level was 75 mg/kg bw/d in both sexes of rats for oral subchronic toxicity. The US EPA’s Benchmark Dose Software (BMDS, Version 1.4.1) was used to model the data to derive a BMDL10. The lowest (most precautionary) BMDL10 from the renal toxicity endpoint in the 90-day oral toxicity study was 102 mg/kg bw/d. In addition to McCain et al (2015) rat oral 90-day repeated dose study, the US National Toxicology Program (NTP) has conducted two additional 90-day drinking water studies on sodium tungstate, one in Sprague-Dawley rats and a second one in B6C3F1 mice (10/sex/species/dose). The study design included doses of 0, 125, 250, 500, 1000, or 2000 mg/L. The in-life study phase has been completed but no study report has yet been issued. Currently, available in the US NTP website are graphs and Tables are preliminary results, but no full report has been issued. Furthermore, at the 2012 Annual Meeting of the Society of Toxicology, a Scientific Poster was presented detailing preliminary results of the NTP study. Preliminary results confirm the results of the McCain gavage study, showing the kidney as the major target organ for tungstate (especially at high drinking water doses of 1,000 and 2,000 mg/L). The US NTP's Sodium Tungstate Dihydrate final study report may be avialble in 2022. Repeated Dose Toxicity - Inhalation Route: No inhalation repeated dose toxicity data of sufficient quality were available for tungsten dioxide; however, data were available for tungsten oxide, which will be used for reading-across. A 28-day inhalation toxicity study conducted according to OECD 412 is available on tungsten oxide (also known as tungsten blue oxide or TBO), which is considered the key repeated dose study. In this study, 5 rats/sex/dose were given TBO nose-only for 6 hours per day, 7 days/week, for 28 days (with a 14-day recovery period) at doses of 0 (control), 0.08, 0.325, and 0.65 mg/L air. The NOAEC was deemed to be > 0.65 mg/L air (650 mg/m3), as no significant effects were reported. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a0418f5-a107-4065-9ff6-e0e628fe808e/documents/1bf7264a-ab2a-4b4d-a0fa-25b9b30a917f_55c17777-212a-464b-b9c2-f7dc4761a4ca.html,,,,,, Tungsten dioxide,12036-22-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a0418f5-a107-4065-9ff6-e0e628fe808e/documents/1bf7264a-ab2a-4b4d-a0fa-25b9b30a917f_55c17777-212a-464b-b9c2-f7dc4761a4ca.html,Sub-chronic toxicity – systemic effects,oral,BMDL10,102 mg/kg bw/day,,rat Tungsten dioxide,12036-22-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/3a0418f5-a107-4065-9ff6-e0e628fe808e/documents/1bf7264a-ab2a-4b4d-a0fa-25b9b30a917f_55c17777-212a-464b-b9c2-f7dc4761a4ca.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,650 mg/m3,,rat Tungsten dioxide,12036-22-5," No acute toxicity data are available for tungsten dioxide. However, in an acute oral toxicity study conducted in rats and according to OECD 423, the LD50 was reported to be >2000 mg/kg for tungsten trioxide. Moreover, in an acute inhalation toxicity study conducted in rats and according to OECD 403, the LC50 was reported to be >5.36 mg/L for tungsten trioxide. These data are used for read-across to tungsten dioxide. An acute dermal toxicity study was available on sodium tungstate, which will be used for read-across. The acute dermal LD50 for sodium tungstate was determined to be > 2000 mg/kg. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a0418f5-a107-4065-9ff6-e0e628fe808e/documents/IUC5-414d2b24-b08e-4ea4-9d22-5393cb83e198_55c17777-212a-464b-b9c2-f7dc4761a4ca.html,,,,,, Tungsten dioxide,12036-22-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a0418f5-a107-4065-9ff6-e0e628fe808e/documents/IUC5-414d2b24-b08e-4ea4-9d22-5393cb83e198_55c17777-212a-464b-b9c2-f7dc4761a4ca.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Tungsten dioxide,12036-22-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a0418f5-a107-4065-9ff6-e0e628fe808e/documents/IUC5-414d2b24-b08e-4ea4-9d22-5393cb83e198_55c17777-212a-464b-b9c2-f7dc4761a4ca.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Tungsten dioxide,12036-22-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/3a0418f5-a107-4065-9ff6-e0e628fe808e/documents/IUC5-414d2b24-b08e-4ea4-9d22-5393cb83e198_55c17777-212a-464b-b9c2-f7dc4761a4ca.html,,inhalation,discriminating conc.,"5,360 mg/m3",no adverse effect observed, Tungsten disulphide,12138-09-9," Repeated Dose Toxicity - Oral Route: No oral repeated dose toxicity data of sufficient quality are available for tungsten disulphide (target substance). However, repeated oral dose toxicity data are available for sodium tungstate (source substance), which will be used for reading across. Due to lower water solubility and lower toxicity for the target substance compared to the source substance, the resulting read across from the source substance to the target substance is appropriate as a conservative estimate of potential toxicity for this endpoint. In addition, read across is appropriate because the classification and labelling is more protective for the source substance than the target substance, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, lower for the source substance. For more details, refer to the read-across category approach included in the Category section of this IUCLID submission and/or as an Annex in the CSR. The read across study on sodium tungstate was sponsored conducted the United States Army Center for Health Promotion and Preventive Medicine and published byMcCain et al. (2015). The 90-day oral toxicity study was conducted in rats according to the procedure described in the Environmental Protection Agency (EPA) Health Effects Testing Guidelines (40 CFR, Part 798.2650) in compliance with Good Laboratory Practice. Briefly, this study of the subchronic toxicity of sodium tungstate dihydrate aqueous solution in male and female Sprague-Dawley rats was evaluated by daily oral gavage of 0, 10, 75, 125, or 200 mg/kg bw/d for 90 days. Measured parameters included food consumption, body weight measurements, hematology, clinical chemistry, and histopathological changes. There was a significant decrease in food consumption and body weight gain in males at 200 mg/kg bw/d from days 77 to 90; however, there was no effect in food consumption and body weights in females. There were no changes in the hematological and clinical parameters studied. Histopathological changes were seen in kidney of male and female and epididymis of male rats. The histopathological changes observed in the kidneys of male and female rats dosed at 125 or 200 mg/k/d consisting of mild to severe cortical tubule basophilia in 2 high-dose groups. Histological changes in epididymides included intraluminal hypospermia with cell debris in the 200 mg/kg bw/day dosed male rats. Histopathological changes were observed in the glandular stomach including inflammation and metaplasia in the high-dose groups (125 or 200 mg/kg bw/day) of both sexes of rats. Based on histopathology effects seen in the kidneys, the lowest observable adverse effect level was 125 mg/kg bw/d and the no observable adverse effect level was 75 mg/kg bw/d in both sexes of rats for oral subchronic toxicity. The USEPA’s Benchmark Dose Software (BMDS, Version 1.4.1) was used to model the data to derive a BMDL10. The lowest (most precautionary) BMDL10 from the renal toxicity endpoint in the 90-day oral toxicity study was 102 mg/kg bw/d. In addition to McCain et al. (2015) rat oral 90-day repeated dose study, the US National Toxicology Program (NTP) has conducted two additional 90-day drinking water studies, one in Sprague-Dawley rats and a second one in B6C3F1 mice (10/sex/species/dose). The study design included doses of0, 125, 250, 500, 1000, or 2000 mg/L. The in-life study phase has been completed but no study report has yet been issued. Currently, available in the US NTP website are graphs and Tables are preliminary results, but no full report has been issued. Furthermore, at the 2012 Annual Meeting of the Society of Toxicology, a Scientific Poster was presented detailing preliminary results of the NTP study. Preliminary results confirm the results of the McCain gavage study, showing the kidney as the major target organ for tungstate (especially at high drinking water doses of 1,000 and 2,000 mg/L). In a personal communication, the U.S. NTP Study Coordinator, Dr. Mamta Behl estimated that final reports will be available in 2 to 3 years. Repeated Dose Toxicity - Inhalation Route: No repeat dose toxicity data of sufficient quality is available for tungsten disulphide (target substance). However, repeat dose inhalation toxicity data are available for tungsten oxide (source substance). Due to higher water solubility in in vitro bioaccessibility in synthetic lysosomal and interstitial fluids simulating inhalation exposure, for the target substance compared to the source substance, the resulting read across is appropriate as a conservative estimate of potential toxicity for this endpoint. In addition, read-across is appropriate for this endpoint because the classification and labelling is the same for the source and target substances, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, sufficiently similar. For more details, refer to the attached description of the read-across approach. A 28-day inhalation toxicity study conducted according to OECD 412 is available on tungsten oxide (source substance), which was used for reading across and is considered the key repeated dose study. In this study, 5 rats/sex/dose were given TBO nose-only for 6 hours per day, 7 days/week, for 28 days (with a 14-day recovery period) at doses of 0 (control), 0.08, 0.325, and 0.65 mg/L air. The NOAEC was deemed to be > 0.65 mg/L air (650 mg/m3), as no significant effects were reported. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c783c67-bcef-450b-8bc0-28641abe0f82/documents/2cd909dd-6731-492d-86e5-b0ee474a8b53_4d40603e-0613-436f-9956-bd90fb848f71.html,,,,,, Tungsten disulphide,12138-09-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c783c67-bcef-450b-8bc0-28641abe0f82/documents/2cd909dd-6731-492d-86e5-b0ee474a8b53_4d40603e-0613-436f-9956-bd90fb848f71.html,Sub-chronic toxicity – systemic effects,oral,BMDL10,102 mg/kg bw/day,,rat Tungsten disulphide,12138-09-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2c783c67-bcef-450b-8bc0-28641abe0f82/documents/2cd909dd-6731-492d-86e5-b0ee474a8b53_4d40603e-0613-436f-9956-bd90fb848f71.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,650 mg/m3,,rat Tungsten disulphide,12138-09-9," Acute Oral Toxicity: The study was carried out based on the guidelines described in: EC Commission Directive 96/54/EC, Part B.1 tris ""Acute Toxicity-Oral, Acute Toxic Class Method"" and OECD No.423, ""Acute Oral Toxicity-Acute Toxic Class Method"". Tungsten disulphide was administered by oral gavage to three Wistar rats of each sex at 2000 mg/kg body weight. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (day 15). No mortality occurred. The oral LD50 value of tungsten disulphide in Wistar rats was established to exceed 2000mg/kg body weight.   Acute Inhalation Toxicity: The acute inhalation toxicity of tungsten disulfide was studied by nose-only exposure of one group of five male and five female rats for a 4-hour period to a test atmosphere containing an aerosol of tungsten disulfide at the limit concentration of 5.25 ± 0.13 g/m3. The Mass Median Aerodynamic Diameter of the particles in the test atmosphere was measured once before and once during exposure and yielded 2.7 and 3.0 µm, respectively. The distribution of particle sizes had a geometric standard deviation of 1.9 in both instances. After exposure, the animals were kept for a 14-day observation period. Clinical signs during exposure consisted of a slightly decreased breathing rat in right animals as well as labored breathing in one animal. All animals felt cold after exposure and had a black discoloration on their heads. The overall body weight gain in males were within normal limits. Overall body weight gain in females was within normal limits during the first week of the observation period, and low during the second week of the observation period. No mortality occurred during exposure or during the 14 -day observation period. The 4-hour LC50 value of an aerosol of tungsten disulfide was larger than 5.25 g/m3 for both sexes.   Acute Dermal Toxicity:  No acute dermal toxicity data of sufficient quality is available for tungsten disulphide (target substance). However, acute dermal toxicity data are available for tungsten metal (source substance), which will be used for reading across. Similar water solubility and lower toxicity for the target substance compared to the source substance, the resulting read across from the source substance to the target substance is appropriate to estimate of potential toxicity for this endpoint. For more details, refer to the attached description of the read-across approach. An acute dermal toxicity study on tungsten metal (source substance) conducted according to OECD 402 reported no deaths and no evidence of a systemic response in any animal throughout the study following a single dermal application of the test substance to rats at a dose level of 2000 mg/kg-bw.  The acute lethal dose was determined to be greater than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c783c67-bcef-450b-8bc0-28641abe0f82/documents/6f9e31e1-d1e4-484f-97c0-1ea642907111_4d40603e-0613-436f-9956-bd90fb848f71.html,,,,,, Tungsten disulphide,12138-09-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c783c67-bcef-450b-8bc0-28641abe0f82/documents/6f9e31e1-d1e4-484f-97c0-1ea642907111_4d40603e-0613-436f-9956-bd90fb848f71.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tungsten disulphide,12138-09-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c783c67-bcef-450b-8bc0-28641abe0f82/documents/6f9e31e1-d1e4-484f-97c0-1ea642907111_4d40603e-0613-436f-9956-bd90fb848f71.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Tungsten disulphide,12138-09-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2c783c67-bcef-450b-8bc0-28641abe0f82/documents/6f9e31e1-d1e4-484f-97c0-1ea642907111_4d40603e-0613-436f-9956-bd90fb848f71.html,,inhalation,LC50,5.25 mg/m3,no adverse effect observed, Tungsten hexachloride,13283-01-7," There are no data on repeated dose toxicity available for Tungsten hexachloride. Thus, available data from a 90-day subchronic oral toxicity study in rats treated with 0, 10, 75, 125 and 200 mg/kg bw/day Sodium tungstate dihydrate (source substance) was used to assess in a read-across approach the specific organ toxicity of Tungsten hexachloride (target substance) There were considerable histopathological changes in the kidneys of male and female rats. Mild to severe regeneration of 18 renal cortical tubules was noted in 1/9 and 10/10 males and 1/10 and 8/10 females in the 125 and 200 mg/kg bw /day dosage groups, respectively. The LOAEL was considered to be 125 mg/kg bw/day based on kidney histopathological results and the NOAEL was considered to be 75 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b04dfe58-a772-496b-b730-262af1828e6d/documents/ad0d4579-25b5-4134-9866-c497c9012932_07935a1a-59fd-4503-a652-096f3a5fa5ff.html,,,,,, Tungsten hexachloride,13283-01-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b04dfe58-a772-496b-b730-262af1828e6d/documents/ad0d4579-25b5-4134-9866-c497c9012932_07935a1a-59fd-4503-a652-096f3a5fa5ff.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,75 mg/kg bw/day,,rat Tungsten hexachloride,13283-01-7," In accordance with REACH Regulation (EC) No 1907/2006, Annex VIII, column 2 of information requirement section 8.5, no acute toxicity testing need to be conducted since the test item is classified as corrosive to the skin (Cat. 1B/C). Supporting information is available from a report of the Agency for Toxic Substances and Disease Registry (ATSDR 2005). In this report, a publication is cited applying a 5 % solution of Tungsten hexachloride to the rabbit skin. All animals died in the mid and high dose group (200 and 1000 mg/kg b.w.) and none in the low dose group (100 mg/kg b.w.). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b04dfe58-a772-496b-b730-262af1828e6d/documents/cf39df78-4709-4be2-a991-1d848f986655_07935a1a-59fd-4503-a652-096f3a5fa5ff.html,,,,,, Tungsten hexafluoride,7783-82-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): Since WF6 is hydrolising rapidly to HF under ambient and physiological conditions, read across to studies on HF and NaF was done. It is turning out that the fluoride anion is inducing adverse effects, while the effect of the sodium kation or proton (Na+ or H+) is negigible. Tungsten oxides are not considered as dangerous/toxic. So, the read across data are the best possible approach to describe the properties of WF6 and its hydrolisation products. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eea7f535-b058-46f1-933b-5a1f9e19d8f7/documents/IUC5-ec7480e2-4322-4518-9444-f84f3c16bb56_40e0bcc5-650b-4daf-990f-fe614f12f530.html,,,,,, Tungsten hexafluoride,7783-82-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eea7f535-b058-46f1-933b-5a1f9e19d8f7/documents/IUC5-ec7480e2-4322-4518-9444-f84f3c16bb56_40e0bcc5-650b-4daf-990f-fe614f12f530.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,2.1 mg/m3,,rat Tungsten hexafluoride,7783-82-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): This studay supported by other inhalation exposure studies and therefore considered as valid. HF has been examined by several laboratories over the last decades and published/well accepted LC50 values are in a very narrow range. The most conservative LC50 value was chosen. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eea7f535-b058-46f1-933b-5a1f9e19d8f7/documents/IUC5-54b8b9ab-c982-4650-b8ae-afbca744cce9_40e0bcc5-650b-4daf-990f-fe614f12f530.html,,,,,, Tungsten hexafluoride,7783-82-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eea7f535-b058-46f1-933b-5a1f9e19d8f7/documents/IUC5-54b8b9ab-c982-4650-b8ae-afbca744cce9_40e0bcc5-650b-4daf-990f-fe614f12f530.html,,inhalation,LC50,"2,700 mg/m3",adverse effect observed, Tungsten oxide,39318-18-8," Repeated Dose Toxicity - Oral Route: No oral repeated dose toxicity data of sufficient quality are available for tungsten oxide (target substance). However, repeated oral dose toxicity data are available for sodium tungstate (source substance), which are used for read-across. Due to lower water solubility and lower toxicity for the target substance compared to the source substance, the resulting read-across from the source substance to the target substance is appropriate as a conservative estimate of potential toxicity for this endpoint. In addition, read-across is appropriate because the classification and labelling is more protective for the source substance than the target substance, the PBT/vPvB profile is the same, and the dose descriptors are, or are expected to be, lower for the source substance. For more details, refer to the read-across category approach description in the Category section of this IUCLID submission or Annex 3 of the CSR. The read-across study on sodium tungstate was sponsored conducted the United States Army Center for Health Promotion and Preventive Medicine and published by McCain et al (2015). The 90-day oral toxicity study was conducted in rats according to the procedure described in the Environmental Protection Agency (EPA) Health Effects Testing Guidelines (40 CFR, Part 798.2650) in compliance with Good Laboratory Practice. Briefly, this study of the subchronic toxicity of sodium tungstate dihydrate aqueous solution in male and female Sprague-Dawley rats was evaluated by daily oral gavage of 0, 10, 75, 125 or 200 mg/kg bw/d for 90 days. Measured parameters included food consumption, body weight measurements, hematology, clinical chemistry, and histopathological changes. There was a significant decrease in food consumption and body weight gain in males at 200 mg/kg bw/d from days 77 to 90; however, there was no effect in food consumption and body weights in females. There were no changes in the hematological and clinical parameters studied. Histopathological changes were seen in kidney of male and female and epididymis of male rats. The histopathological changes observed in the kidneys of male and female rats dosed at 125 or 200 mg/k/d consisting of mild to severe cortical tubule basophilia in 2 high-dose groups. Histological changes in epididymides included intraluminal hypospermia with cell debris in the 200 mg/kg bw/day dosed male rats. Histopathological changes were observed in the glandular stomach including inflammation and metaplasia in the high-dose groups (125 or 200 mg/kg bw/day) of both sexes of rats. Based on histopathology effects seen in the kidneys, the lowest observable adverse effect level was 125 mg/kg bw/d and the no observable adverse effect level was 75 mg/kg bw/d in both sexes of rats for oral subchronic toxicity. The USEPA’s Benchmark Dose Software (BMDS, Version 1.4.1) was used to model the data to derive a BMDL10. The lowest (most precautionary) BMDL10 from the renal toxicity endpoint in the 90-day oral toxicity study was 102 mg/kg bw/d. In addition to McCain et al (2015) rat oral 90-day repeated dose study, the US National Toxicology Program (NTP) has conducted two additional 90-day drinking water studies, one in Sprague-Dawley rats and a second one in B6C3F1 mice (10/sex/species/dose). The study design included doses of0, 125, 250, 500, 1000 or 2000 mg/L. The in-life study phase has been completed but no study report has yet been issued. Currently, available in the US NTP website are graphs and Tables are preliminary results, but no full report has been issued. Furthermore, at the 2012 Annual Meeting of the Society of Toxicology, a Scientific Poster was presented detailing preliminary results of the NTP study. Preliminary results confirm the results of the McCain gavage study, showing the kidney as the major target organ for tungstate (especially at high drinking water doses of 1,000 and 2,000 mg/L). The US NTP's final reports of sodium tungstate would be available by 2022.   Repeated Dose Toxicity - Inhalation Route: A 28-day inhalation toxicity study conducted according to OECD 412 is available on tungsten oxide, which is considered the key repeated dose study. In this study, 5 rats/sex/dose were given tungsten oxide nose-only for 6 hours per day, 7 days/week, for 28 days (with a 14-day recovery period) at doses of 0 (control), 0.08, 0.325, and 0.65 mg/L air. The NOAEC was deemed to be > 0.65 mg/L air (650 mg/m3), as no significant effects were reported. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8644fef7-9ab9-4011-8854-4e046e3ea169/documents/a04cfaa8-0736-4bfb-881b-38fbae3e8b5e_dbab2869-5bbd-4a9d-afdd-391fd58a8631.html,,,,,, Tungsten oxide,39318-18-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8644fef7-9ab9-4011-8854-4e046e3ea169/documents/a04cfaa8-0736-4bfb-881b-38fbae3e8b5e_dbab2869-5bbd-4a9d-afdd-391fd58a8631.html,Sub-chronic toxicity – systemic effects,oral,BMDL10,102 mg/kg bw/day,,rat Tungsten oxide,39318-18-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8644fef7-9ab9-4011-8854-4e046e3ea169/documents/a04cfaa8-0736-4bfb-881b-38fbae3e8b5e_dbab2869-5bbd-4a9d-afdd-391fd58a8631.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,650 mg/m3,,rat Tungsten oxide,39318-18-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8644fef7-9ab9-4011-8854-4e046e3ea169/documents/a04cfaa8-0736-4bfb-881b-38fbae3e8b5e_dbab2869-5bbd-4a9d-afdd-391fd58a8631.html,Repeated dose toxicity – local effects,inhalation,NOAEC,650 mg/m3,no adverse effect observed,rat Tungsten oxide,39318-18-8," In an acute oral toxicity study conducted on rats and according to OECD 423 the LD50 was reported to be >2000 mg/kg.  No acute inhalation toxicity data of sufficient quality are available for tungsten oxide.  However, acute inhalation toxicity data are available for tungsten trioxide, which are used for read-across. In the acute inhalation toxicity study conducted on rats and according to OECD 403 and EU Method B.2, the 4hr-LC50 was reported to be >5.36 mg/L for tungsten trioxide. No acute dermal toxicity data of sufficient quality are available for tungsten oxide.  However, acute dermal toxicity data are available for sodium tungstate, which are be used for read-across. In the acute dermal toxicity study conducted on rats and according to OECD 402 LD50  was reported to be >2000 mg/kg for sodium tungstate. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8644fef7-9ab9-4011-8854-4e046e3ea169/documents/IUC5-bc0e4348-1ad4-4347-84f9-c2d18aaa7e7e_dbab2869-5bbd-4a9d-afdd-391fd58a8631.html,,,,,, Tungsten oxide,39318-18-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8644fef7-9ab9-4011-8854-4e046e3ea169/documents/IUC5-bc0e4348-1ad4-4347-84f9-c2d18aaa7e7e_dbab2869-5bbd-4a9d-afdd-391fd58a8631.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Tungsten oxide,39318-18-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8644fef7-9ab9-4011-8854-4e046e3ea169/documents/IUC5-bc0e4348-1ad4-4347-84f9-c2d18aaa7e7e_dbab2869-5bbd-4a9d-afdd-391fd58a8631.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, Tungsten oxide,39318-18-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8644fef7-9ab9-4011-8854-4e046e3ea169/documents/IUC5-bc0e4348-1ad4-4347-84f9-c2d18aaa7e7e_dbab2869-5bbd-4a9d-afdd-391fd58a8631.html,,inhalation,LC50,"5,360 mg/m3",no adverse effect observed, tungsten zirconium oxide,39290-95-4," No data are available on the repeated dose toxicity of tungsten zirconium oxide. As the comparison of basic toxicological data (Annex VII endpoints) for tungsten zirconium (hydroxide) oxide and zirconium dioxide confirmed the validity of the read across assumption, i.e. that the addition of tungsten to the zirconium dioxide crystal lattice does not affect the unhazardous character of zirconium dioxide, higher toxicological endpoints such as the repeated dose toxicity endpoints were covered using the approach followed in the zirconium dioxide dossier. Repeated dose toxicity: oral Two studies were used in a weight of evidence approach to cover this endpoint: - Rossiello (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test via oral route in rats with the read across substance zirconium acetate according to OECD guideline 422 (GLP). A NOAEL of >=1000 mg/kg bw/day (expressed as zirconium acetate anhydrous) was derived. No adverse effects were reported in this study. - No effects were reported after oral administration to rats during 17 weeks of zirconium basic carbonate (hydrated form) in the form of a moist paste containing 20.9% zirconium dioxide equivalent. The total intake of zirconium dioxide during the test period was 0, 0.9, 9 and 103.5 g. The equivalent NOAEL for zirconium dioxide was >= 3150-7080 mg/kg bw/day (Harrison et al., 1951). Repeated dose toxicity: inhalation No effects were reported in the study of Spiegl et al. (1956) for any of the species studied (cat, dog, guinea pig, rabbit and rat) after inhalation of zirconium dioxide dust during 30 or 60 days. The 30-day NOAEC was >= 100.8 mg ZrO2/m3 and the 60-day NOAEC was >= 15.4 mg ZrO2/m3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/34f68bc2-e30f-4df1-b910-361fa3d71e35/documents/51b26270-62d2-4973-892d-733ac37d600e_6fdaeb90-c404-4a95-85b6-df427541d036.html,,,,,, tungsten zirconium oxide,39290-95-4," Acute oral toxicity In an acute oral toxicity study with female rats (Klimisch 1, Appl, 2018) following the acute toxic class method in accordance with OECD guideline 423, the LD50 of tungsten zirconium (hydroxide) oxide was determined to be greater than 2000 mg/kg bw for female animals, observed over a period of 14 days after dosing. No mortality was observed during the test. Acute toxicity inhalation In an acute inhalation toxicity study with rats, performed according to OECD guideline 436 using the read across substance zirconium dioxide (Klimisch 1, Smith, 2010), an LC50 greater than 4.3 mg/L (actual exposure; maximum technically achievable concentration) was derived. No mortality was observed during the test. Acute dermal toxicity A key study is available for the oral and inhalation route of exposure. According to the REACH Regulation, for substances other than gases, only one additional route of exposure should be tested other than the oral route of exposure for acute toxicity (Annex VIII, Section 8.5, Column 2). Therefore, it is not necessary to perform an acute dermal toxicity study. Moreover, since the substance does not meet the criteria for classification as STOT SE by oral route and no systemic effects have been observed in the in vivo studies with dermal application (i.e. the GPMT study on skin sensitisation, Tarcai, 2018), no study is needed and the substance can be concluded not to be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/34f68bc2-e30f-4df1-b910-361fa3d71e35/documents/f53e8183-738c-4e27-b88b-0bcc802b64c7_6fdaeb90-c404-4a95-85b6-df427541d036.html,,,,,, Undecanedioic acid,1852-04-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b51da4b-10d4-4fe9-b07c-ca7d19c8c230/documents/IUC5-ce595dbe-7e85-4a3c-80d5-748316159dff_6cf69a12-6ca9-4eaf-bc77-16b33d8a8f8e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Undecanedioic acid,1852-04-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b51da4b-10d4-4fe9-b07c-ca7d19c8c230/documents/IUC5-43ac12e3-625c-4169-a03f-402762907687_6cf69a12-6ca9-4eaf-bc77-16b33d8a8f8e.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Undecanedioic acid,1852-04-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b51da4b-10d4-4fe9-b07c-ca7d19c8c230/documents/IUC5-43ac12e3-625c-4169-a03f-402762907687_6cf69a12-6ca9-4eaf-bc77-16b33d8a8f8e.html,,dermal,LD50,"6,000 mg/kg bw",adverse effect observed, "Undecanol, branched and linear",128973-77-3,"There are no key data for undecan-1-ol branched and linear (CAS: 128973-77-3, EC: 603-309-4).   In the key study, no adverse effects were seen after dietary administration of Alcohols, C14-15 branched and linear for 90 days to rats (Ito et al., 1978, reliability 2) which reported a NOAEL value of >3548 mg/kg bw/day. A read across from a reliable 13 week dietary study in rats using hexan-1-ol reported a NOAEL of 1127 mg/kg (Scientific Associates Inc., 1966). No adverse effects were noted at any of the dose levels administered during the study.   In addition a 90 day repeated dose dermal study (Wil Research 1995, reliability 3) in rats where a multi-constituent solution containing circa 50% decan-1-ol and circa 45% octan-1-ol (semi-occluded conditions) reported no systemic effects at the highest dose tested. The study did however give rise to marked dermal irritative effect. It is however important to take in to account the different test protocol that was used, that is a 90 day repeated dose dermal study (6 hours/day for 5 days/week) compared to a standard 4 hour dermal irritation study and the different species (rats instead of rabbit) and test duration (90 days vs. 4 hours).   A combined repeated dose toxicity study with the reproduction/developmental toxicity screening test with the structural analogue Alcohols C9-11 branched and linear has been conducted according to OECD Test Guideline 422 and in compliance with GLP. A NOAEL of ≥1000 mg/kg bw/day (CRL, 2023o) was established based on no adverse effects observed in Han Wistar rats.   There is an ongoing 90-day repeated oral dose toxicity study conducted according to OECD Test Guideline 408 with this same analogue Alcohols, C9-11, branched and linear. The test is running late due to sample issues at the laboratory site (please see CRO statement for further details in the EPSR titled Repeated dose toxicity: oral_Ongoing 408 study with C911BL'). As soon as a report is made available, data will used as read-across to the registered substance Undecanol, branched and linear (CAS: 128973-77-3) and the dataset as well as the DNELs will be updated according to the results.    ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab920809-30f7-4b5b-a5d6-3fcd1eb3502f/documents/87815fd3-f0de-4e5e-aad3-65499d1b7250_0f93e965-0a52-4683-9fa7-edd9da097db1.html,,,,,, "Undecanol, branched and linear",128973-77-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab920809-30f7-4b5b-a5d6-3fcd1eb3502f/documents/87815fd3-f0de-4e5e-aad3-65499d1b7250_0f93e965-0a52-4683-9fa7-edd9da097db1.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Undecanol, branched and linear",128973-77-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab920809-30f7-4b5b-a5d6-3fcd1eb3502f/documents/87815fd3-f0de-4e5e-aad3-65499d1b7250_0f93e965-0a52-4683-9fa7-edd9da097db1.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,548 mg/kg bw/day",,rat "Undecanol, branched and linear",128973-77-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab920809-30f7-4b5b-a5d6-3fcd1eb3502f/documents/87815fd3-f0de-4e5e-aad3-65499d1b7250_0f93e965-0a52-4683-9fa7-edd9da097db1.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,"1,000 mg/kg bw/day",,rat "Undecanol, branched and linear",128973-77-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ab920809-30f7-4b5b-a5d6-3fcd1eb3502f/documents/87815fd3-f0de-4e5e-aad3-65499d1b7250_0f93e965-0a52-4683-9fa7-edd9da097db1.html,Repeated dose toxicity – local effects,dermal,NOAEL,2.8 mg/cm2,adverse effect observed,rat "Undecanol, branched and linear",128973-77-3,"The key acute oral toxicity study was conducted with undecan-1-ol branched and linear (CAS:128973-77-3, EC: 603-309-4) according to OECD test guidelines found an LD50 of >5000 mg/kg in Wistar rats, all rats survived the 14 day observation period after a single exposure (Biolab SGS, 1981). There are no reliable key information for acute inhalation or dermal toxicity on undecan-1-ol branched and linear (CAS 128973-77-3), therefore information has been read across from structurally similar substance undecan-1-ol (CAS: 1122-42-5). The key acute inhalation toxicity study was conducted prior to the establishment of OECD test guidelines and prior to the introduction of GLP, an LC50 of >700 mgm^3 air was found in Sprague Dawley rats over 6 hours (Younger labs, 1972). The key acute dermal toxicity study was conducted prior to the establishment of OECD test guidelines and prior to the introduction of GLP, an LD50 of >5010 mg/kg but less than <7940 mg/kg was found in New Zealand white rabbits (Younger Labs, 1972). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab920809-30f7-4b5b-a5d6-3fcd1eb3502f/documents/9dfc336a-e2a9-429a-82a3-4cd209e321f2_0f93e965-0a52-4683-9fa7-edd9da097db1.html,,,,,, "Undecanol, branched and linear",128973-77-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab920809-30f7-4b5b-a5d6-3fcd1eb3502f/documents/9dfc336a-e2a9-429a-82a3-4cd209e321f2_0f93e965-0a52-4683-9fa7-edd9da097db1.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Undecanol, branched and linear",128973-77-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab920809-30f7-4b5b-a5d6-3fcd1eb3502f/documents/9dfc336a-e2a9-429a-82a3-4cd209e321f2_0f93e965-0a52-4683-9fa7-edd9da097db1.html,,dermal,LD50,"5,010 mg/kg bw",no adverse effect observed, "Undecanol, branched and linear",128973-77-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ab920809-30f7-4b5b-a5d6-3fcd1eb3502f/documents/9dfc336a-e2a9-429a-82a3-4cd209e321f2_0f93e965-0a52-4683-9fa7-edd9da097db1.html,,inhalation,LC50,700 mg/m3,no adverse effect observed, Urea phosphate,4861-19-2,"Repeated toxicity studies have not been conducted with the target substance. The repeated dose toxicity was concluded based on data of analogues. The rationale to read across data is attached in Section 13.  It is of note that the DNELs are based on the recent EFSA re-evaluation of the ADI of phosphorus, which has been set as 40 mg P/kg bw/day.     ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/523406a2-9662-46cd-ae8d-17cade224480/documents/139fa51b-5b5f-4f22-9a57-7fb9be7f2bd2_2dbbcec8-0a0e-4208-8210-732412a779bf.html,,,,,, Urea phosphate,4861-19-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/523406a2-9662-46cd-ae8d-17cade224480/documents/139fa51b-5b5f-4f22-9a57-7fb9be7f2bd2_2dbbcec8-0a0e-4208-8210-732412a779bf.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Urea phosphate,4861-19-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/523406a2-9662-46cd-ae8d-17cade224480/documents/139fa51b-5b5f-4f22-9a57-7fb9be7f2bd2_2dbbcec8-0a0e-4208-8210-732412a779bf.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,>= 500 mg/kg bw/day,,rat Urea phosphate,4861-19-2,No data on acute toxicity are available for urea phosphate. Since urea phosphate is classified as corrosive to the skin further testing for acute toxicity is not required according to column 2 of Annex VII and VIII Section 8.5. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/523406a2-9662-46cd-ae8d-17cade224480/documents/IUC5-39eabcda-9859-40e5-8692-88de82865f95_2dbbcec8-0a0e-4208-8210-732412a779bf.html,,,,,, "3-[4-[[4-(dimethylcarbamoylamino)phenyl]methyl]phenyl]-1,1-dimethylurea",10097-09-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4bbc96ca-4aad-4207-9745-bc0fc9ae022b/documents/1b61f3b5-ee3d-48d5-a52b-31a7eac807bd_9206f399-6b4a-427c-b235-eb174f83f04a.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,150 mg/kg bw/day,,rat "3-[4-[[4-(dimethylcarbamoylamino)phenyl]methyl]phenyl]-1,1-dimethylurea",10097-09-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4bbc96ca-4aad-4207-9745-bc0fc9ae022b/documents/8f868c21-0bbe-4b92-ae82-a6952a4db589_9206f399-6b4a-427c-b235-eb174f83f04a.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "3-[4-[[4-(dimethylcarbamoylamino)phenyl]methyl]phenyl]-1,1-dimethylurea",10097-09-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4bbc96ca-4aad-4207-9745-bc0fc9ae022b/documents/8f868c21-0bbe-4b92-ae82-a6952a4db589_9206f399-6b4a-427c-b235-eb174f83f04a.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "trans-1,4-diureido-cyclohexane",68533-01-7," In an acute oral toxicity study according to the Acute Toxic Class method, clinical signs were observed in the in female rats receiving 2000 mg/kg bw (impaired general state and piloerection in all animals), but not in the second group receiving 300 mg/kg. No mortality occurred in any of the dose groups. There were no macroscopic pathological findings in all animals sacrificed at the end of the observation period. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14ba1b66-3974-4182-bcd4-96549ddb9c87/documents/9e08a308-55c2-4578-9ff4-d8c24a79e391_4f1d443d-6594-411f-bc2e-ea202b4c5051.html,,,,,, Oligomerisation reaction products of glyoxal and urea.,53037-34-6, Repeated dose toxicity (28 days): Test method OECD 422. GLP study. The NOAEL after at least 28 days of oral exposure to test item was determined to be 250 mg/kg bw/day in rats (basis for effect: minor changes in clinical chemistry and urinalysis parameters and the ulcers of the non-glandular mucosa of the stomach at 1000 mg/kg bw/day dose level) . Repeated dose toxicity (90-days): Test method OECD 408. GLP study. The NOAEL after a 90 days of oral exposure was determined to be 1000 mg/kg bw/day in rats (basis on no overt adverse effects that could be ascribed to the test item administration). ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc2fb988-05da-405f-82fc-e2d781e92bc9/documents/IUC5-1d82ae3f-51d1-4b9d-ac86-7a3108424beb_fb2cee67-9555-4ba6-9152-edd2c85b4138.html,,,,,, Oligomerisation reaction products of glyoxal and urea.,53037-34-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fc2fb988-05da-405f-82fc-e2d781e92bc9/documents/IUC5-1d82ae3f-51d1-4b9d-ac86-7a3108424beb_fb2cee67-9555-4ba6-9152-edd2c85b4138.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Oligomerisation reaction products of glyoxal and urea.,53037-34-6,Acute oral toxicity: Key study: The acute oral LD50 value of the test substance was >2000 mg/kg bw in female rats.Acute dermal toxicity: The acute dermal LD50 value of the test substance was >2000 mg/kg bw in male and female rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc2fb988-05da-405f-82fc-e2d781e92bc9/documents/IUC5-a4a3b23c-ca1d-4e98-a57d-9bc39d39af1c_fb2cee67-9555-4ba6-9152-edd2c85b4138.html,,,,,, Oligomerisation reaction products of glyoxal and urea.,53037-34-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc2fb988-05da-405f-82fc-e2d781e92bc9/documents/IUC5-a4a3b23c-ca1d-4e98-a57d-9bc39d39af1c_fb2cee67-9555-4ba6-9152-edd2c85b4138.html,,oral,LD50,"2,001 mg/kg bw",no adverse effect observed, Oligomerisation reaction products of glyoxal and urea.,53037-34-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fc2fb988-05da-405f-82fc-e2d781e92bc9/documents/IUC5-a4a3b23c-ca1d-4e98-a57d-9bc39d39af1c_fb2cee67-9555-4ba6-9152-edd2c85b4138.html,,dermal,LD50,"2,001 mg/kg bw",no adverse effect observed, "Urea, reaction products with formaldehyde, glyoxal and methanol",92908-36-6," DMDHEU (a surrogate of the submission substance) was subjected to test subchronic oral toxicity in male and female rats and mice. In this study a NOAEL of 3000 mg/kg bw/day was identified for rats (based on statistically significant reduction of male bw compared to controls). There were no adverse effects found in mice, the resulting NOAEL = 6000 mg/kg bw/day (i.e. highest dose tested). Moreover the sumission substance was subjected to a combined repeated dose toxicity study with reproduction/developmental toxicity screening test using male and female rats. Oral dosing for at least 28 days (males, females were treated up to approx. 7 weeks), didn't reveal any treatment-related findings on parental animals, thus resulting in a No Observed Adverse Effect Level (NOAEL) of 1000 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/712f3f64-8139-4cf6-a74e-f136edb6b2ed/documents/adfab854-5be1-413c-a808-9f49f3481742_9393d876-1076-41e3-b468-53b3f129392f.html,,,,,, "Urea, reaction products with formaldehyde, glyoxal and methanol",92908-36-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/712f3f64-8139-4cf6-a74e-f136edb6b2ed/documents/adfab854-5be1-413c-a808-9f49f3481742_9393d876-1076-41e3-b468-53b3f129392f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"3,000 mg/kg bw/day",,rat "Urea, reaction products with formaldehyde, glyoxal and methanol",92908-36-6, In two acute oral toxicity studies LD50 values >2000 mg/kg bw are reported. Two acute dermal toxicity studies in the rat also resulted in LD50 values >2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/712f3f64-8139-4cf6-a74e-f136edb6b2ed/documents/119a6055-53c8-4215-9ce3-dfdb93794f39_9393d876-1076-41e3-b468-53b3f129392f.html,,,,,, "Urea, reaction products with formaldehyde, glyoxal and methanol",92908-36-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/712f3f64-8139-4cf6-a74e-f136edb6b2ed/documents/119a6055-53c8-4215-9ce3-dfdb93794f39_9393d876-1076-41e3-b468-53b3f129392f.html,,oral,discriminating dose,"4,305 mg/kg bw",no adverse effect observed, "Urea, reaction products with formaldehyde, glyoxal and methanol",92908-36-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/712f3f64-8139-4cf6-a74e-f136edb6b2ed/documents/119a6055-53c8-4215-9ce3-dfdb93794f39_9393d876-1076-41e3-b468-53b3f129392f.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "Urea,N'-[3-[[[(dimethylamino)carbonyl]amino]methyl]-3,5,5-trimethylcyclohexyl]-N,N-dimethyl-",39992-90-0,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Basic study is according OECD, therefore quality is good Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): Basic study is according OECD, therefore quality is good ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d76784eb-24d9-4f44-813f-8b6d2bda4641/documents/751ed647-447c-4b85-a5e9-fb584497f63c_f7f3f714-13ec-43b6-b4f2-e2e396caffa5.html,,,,,, "Urea,N'-[3-[[[(dimethylamino)carbonyl]amino]methyl]-3,5,5-trimethylcyclohexyl]-N,N-dimethyl-",39992-90-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d76784eb-24d9-4f44-813f-8b6d2bda4641/documents/751ed647-447c-4b85-a5e9-fb584497f63c_f7f3f714-13ec-43b6-b4f2-e2e396caffa5.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Urea,N'-[3-[[[(dimethylamino)carbonyl]amino]methyl]-3,5,5-trimethylcyclohexyl]-N,N-dimethyl-",39992-90-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d76784eb-24d9-4f44-813f-8b6d2bda4641/documents/751ed647-447c-4b85-a5e9-fb584497f63c_f7f3f714-13ec-43b6-b4f2-e2e396caffa5.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Uridine, 2'-deoxy-5-ethyl-, 3',5'-bis(4-chlorobenzoate)",25137-84-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0c516230-313e-4174-a087-d5a4b3b702e9/documents/c2a811d2-3dd6-4d8d-a683-29153ab56293_eda1e7c8-e7bf-43da-8ac0-2bef3b2b461c.html,,dermal,LD50,"2,000 ",adverse effect observed, Uronium hydrogen sulphate,21351-39-3,"No information is available with Uronium hydrogen sulphate as an aduct of urea and sulphuric acid.As Uronium hydrogen sulphate readily degrades to urea and sulfuric acid and/or sulfate ions in the human body, the assessment of the repeated toxicity of urea sulphate is based on the data available on the degradation products:- Sulfates (as calcium salt): no severe toxicological effect was observed after oral administration of (calcium) sulfate. In a Combined Repeated Dose and Reproduction/Developmental Toxicity Screening Test in rats [OECD TG 422] with calcium sulphate dihydrate, the LOAEL and NOAEL were determined to be 300 mg/kg bw/day and 100 mg/kg bw/day for male rats, and the NOAEL for females was 1000 mg/kg bw/day.- Urea: 12-month carcinogenicity screening studies in the rat and mouse demonstrate that urea is of very low chronic toxicity by the oral route. Similarly, no evidence of local or systemic toxicity was seen in 4-week and 25-week dermal toxicity studies in the rat. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9bc8da08-7ab9-413a-90fb-8f1a40cc4a89/documents/IUC5-12abba27-fabf-47f2-9015-743b0e81625a_febe7245-02bf-4d75-bf76-a6968302c6e0.html,,,,,, Uronium hydrogen sulphate,21351-39-3,"Uronium hydrogen sulphate is not considered to be harmful by oral or dermal route:- Oral LD50 > 2000 mg/kg bw (rat)- Dermal LD50 > 2000 mg/kg bw (rat, no mortality observed)No data by inhalation is available. However there is a low potential for inhalation exposure. In addition, the substance has been demonstrated to be of low toxicity by dermal and oral routes of exposure. Dermal route is more appropriate as skin contact in production and/or use is likely. Testing for acute inhalation toxicity is therefore not justified on scientific grounds or based on exposure considerations. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9bc8da08-7ab9-413a-90fb-8f1a40cc4a89/documents/IUC5-d7454fef-f089-4431-8552-837963564aec_febe7245-02bf-4d75-bf76-a6968302c6e0.html,,,,,, Valeric anhydride,2082-59-9," Data from the corresponding acid has been used to satisfy the endpoint for the acid anhydride. The acute oral toxicity of the test item is very low with an LD50 value of 4600 mg/kg bw in male and female rats. The test item was administered as solution in olive oil ( 2150, 3160, 4640, 6810 mg/kg bw). Mortality and gross pathological findings were restricted to the animals treated with 4640 and 6810 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c47e49fc-f053-4f3a-89f3-afe1f3354e80/documents/15b0693b-3594-46d2-9709-e7e2400e9a69_b0ecccc0-4930-44ec-9022-80c490c6b716.html,,,,,, Valeric anhydride,2082-59-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c47e49fc-f053-4f3a-89f3-afe1f3354e80/documents/15b0693b-3594-46d2-9709-e7e2400e9a69_b0ecccc0-4930-44ec-9022-80c490c6b716.html,,oral,LD50,"4,600 mg/kg bw",no adverse effect observed, Valeryl chloride,638-29-9,The LC50 for valeryl chloride in rats is 2.07 mg/L. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7012cfe-06ba-43e4-8186-69eb86794977/documents/IUC5-02b23eed-1bc6-493e-9318-a73c5897cbcc_c5ca78c2-592e-4e5c-83e7-c889347c050f.html,,,,,, "Vanadate(1-), oxo[phosphato(3-)-κO]-, hydrogen, hydrate (2:2:1)",93280-40-1,Oral: Read-Across; NOAEL = 100 mg/kg bw; rat; 4 wk; according to OECD TG 407; GLP; K2 Inhalation: Read-Across; NOAEL = 1 mg/m³; rat; 90 d; guideline not specified; GLP; K1 Dermal: no study available ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b3708be-fbb5-49ae-ade0-1505e82b16c1/documents/bed85836-7546-464b-88ff-3dcf1faa4947_ffd85329-3a1f-4cab-b24d-26dec5735d46.html,,,,,, "Vanadate(1-), oxo[phosphato(3-)-κO]-, hydrogen, hydrate (2:2:1)",93280-40-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b3708be-fbb5-49ae-ade0-1505e82b16c1/documents/bed85836-7546-464b-88ff-3dcf1faa4947_ffd85329-3a1f-4cab-b24d-26dec5735d46.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Vanadate(1-), oxo[phosphato(3-)-κO]-, hydrogen, hydrate (2:2:1)",93280-40-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b3708be-fbb5-49ae-ade0-1505e82b16c1/documents/bed85836-7546-464b-88ff-3dcf1faa4947_ffd85329-3a1f-4cab-b24d-26dec5735d46.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,1 mg/m3,,rat "Vanadate(1-), oxo[phosphato(3-)-κO]-, hydrogen, hydrate (2:2:1)",93280-40-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1b3708be-fbb5-49ae-ade0-1505e82b16c1/documents/bed85836-7546-464b-88ff-3dcf1faa4947_ffd85329-3a1f-4cab-b24d-26dec5735d46.html,Repeated dose toxicity – local effects,inhalation,NOAEC,1 mg/m3,adverse effect observed,rat "Vanadate(1-), oxo[phosphato(3-)-κO]-, hydrogen, hydrate (2:2:1)",93280-40-1,Oral: LD50 > 50 < 300 mg/kg bw; rat; according to OECD TG 423; GLP; K1Inhalation: LC50 = 3.694 mg/L air; rat; according to OECD TG 403; GLP; K1Dermal: no study available ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b3708be-fbb5-49ae-ade0-1505e82b16c1/documents/9e656859-c793-4ce3-9255-602dd9949c83_ffd85329-3a1f-4cab-b24d-26dec5735d46.html,,,,,, "Vanadate(1-), oxo[phosphato(3-)-κO]-, hydrogen, hydrate (2:2:1)",93280-40-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b3708be-fbb5-49ae-ade0-1505e82b16c1/documents/9e656859-c793-4ce3-9255-602dd9949c83_ffd85329-3a1f-4cab-b24d-26dec5735d46.html,,oral,LD50,< 300 mg/kg bw,adverse effect observed, "Vanadate(1-), oxo[phosphato(3-)-κO]-, hydrogen, hydrate (2:2:1)",93280-40-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1b3708be-fbb5-49ae-ade0-1505e82b16c1/documents/9e656859-c793-4ce3-9255-602dd9949c83_ffd85329-3a1f-4cab-b24d-26dec5735d46.html,,inhalation,LC50,"3,694 mg/m3",adverse effect observed, Vanadium,7440-62-2," Oral: A study via the oral route is available for vanadium carbide nitride. The NOAEL results in a discriminating dose of ≥ 1000 mg/kg bw/d VCN, corresponding to a NOAEL of ≥ 780 mg/kg bw/d V based on vanadium-content conversion. Inhalation: In a 14-d repeated-dose inhalation toxicity study, Sprague-Dawley rats were exposed to micronised vanadium trioxide powder via nose-only inhalation. Test-substance related mortality or any clinical signs of systemic toxicity were not observed at any exposure level. Body weights/body weight gain and food consumption were significantly decreased only at the highest exposure (0.25 mg/L) in males and females. In summary, based on the local effects in the respiratory tract of the test animals at the high exposure level (0.25 mg/L), the NOAEC was 0.02 mg/L (20 mg V2O3/m3). All effects on BAL parameters, lung weights and lung histopathology seen at the lower exposure levels were considered as adaptive responses to divanadium trioxide exposure, rather than an indication of local toxicity. Information on repeated dose toxicity following inhalation exposure to V2O5 is available in a NTP study (k_NTP 2002) with exposure of male and female rats and mice to V2O5 over 16-days, 3-months and 2-years. Pulmonary reactivity to vanadium pentoxide was also investigated following subchronic inhalation exposure in a non-human primate animal model. However, local effects on the respiratory tract are not considered relevant for vanadium (see discussion below). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ae11d0d0-78d9-465f-b8fe-92a5e1c88118/documents/IUC5-96be1274-0d7d-44cc-a21a-d24fd48d4c43_5928507d-dbff-40ce-b071-607cb2406722.html,,,,,, Vanadium,7440-62-2," Vanadium metal is not acutely toxic via the oral, dermal, or inhalation route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae11d0d0-78d9-465f-b8fe-92a5e1c88118/documents/IUC5-b0a4ea63-ef61-4244-b985-edd2e43c3e10_5928507d-dbff-40ce-b071-607cb2406722.html,,,,,, Vanadium,7440-62-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae11d0d0-78d9-465f-b8fe-92a5e1c88118/documents/IUC5-b0a4ea63-ef61-4244-b985-edd2e43c3e10_5928507d-dbff-40ce-b071-607cb2406722.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Vanadium carbide,12070-10-9,"Oral route In an unpublished study report with vanadium carbide nitride, no relevant treatment-related effects were observed after 28-days oral exposure in rats up to the limit dose of 1000 mg/kg bw/day. Consequently, the substances of the poorly soluble vanadium substances read-across group are characterised by an absence of systemic toxicity when administered via oral route up to the limit dose. For details on the oral read across approach please refer to detailed discussion in the respective oral read-across document attached to section 13 of the technical dossier).     Inhalation route In a 14-d repeated-dose inhalation toxicity study, Sprague-Dawley rats were exposed to icronized vanadium trioxide powder via nose-only inhalation. Test-substance related mortality or any clinical signs of systemic toxicity were not observed at any exposure level. Body weights/body weight gain and food consumption were significantly decreased only at the highest exposure (0.25 mg/L) in males and females. In summary, based on the local effects in the respiratory tract of the test animals at the high exposure level (0.25 mg/L), the NOAEC was 0.02 mg/L (20 mg V2O3/m3). All effects on BAL parameters, lung weights and lung histopathology seen at the lower exposure levels were considered as adaptive responses to divanadium trioxide exposure, rather than an indication of local toxicity.   Information on repeated dose toxicity following inhalation exposure to V2O5 is available in a NTP study (k_NTP 2002) with exposure of male and female rats and mice to V2O5 over 16-days, 3-months and 2-years. Pulmonary reactivity to vanadium pentoxide was also investigated following subchronic inhalation exposure in a non-human primate animal model. However, local effects on the respiratory tract are not considered relevant for unreactive vanadium substances (please see discussion below and refer to detailed discussion in the respective inhalation read-across document attached to section 13 of the technical dossier). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b60acf26-d8b1-4742-9686-404343e6b1ce/documents/IUC5-48520230-d552-418c-bd13-ff199e0f6d5b_3312b0ad-860a-454a-a1ee-d86a69e65c4b.html,,,,,, Vanadium carbide,12070-10-9,"Acute oral toxicity: LD50 (rats, females) >5000 mg/kg bw (according to OECD 423 (2001); GLP compliant)   Acute inhalation toxicity: LC50 (rats, 4 hours) > 5.05 mg/L air (actual concentration)(according to OECD 436 (2009); GLP compliant)   Acute dermal toxicity: Annex VIII, point 8.5 of Regulation No 1907/2006 specifies that information on the acute toxicity of substances shall be provided according to the relevant exposure routes. According to point 8.5.3, column 2, testing by the dermal route is appropriate if (1) inhalation of the substance is unlikely, and (2) skin contact in production and/or use is likely, and (3) physicochemical and toxicological properties suggest potential for a significant rate of absorption through the skin. For vanadium carbide, inhalation may be anticipated. Therefore, provision (1) of point 8.5.3 is not fulfilled, but provision (2) is. However, following the HERAG guidance for metals and metal salts (see section 7.1.2 of the technical dossier, dermal absorption), a dermal absorption rate in the range of maximally 0.1-1.0 % can be anticipated. Dermal absorption in this order of magnitude is not considered to be “significant”. Therefore, provision (3) of point 8.5.3 is also not fulfilled. In conclusion, testing for acute toxicity of vanadium carbide via the dermal route is not required according the criteria laid down in Annex VIII, point 8. References:EBRC (2007) HERAG fact sheet - Assessment of occupational dermal exposure and dermal absorption for metals and inorganic metal compounds, EBRC Consulting GmbH, Hannover, Germany, August 2007, 49 pages. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b60acf26-d8b1-4742-9686-404343e6b1ce/documents/IUC5-df945016-e996-4b54-9cc7-6540c1e3738e_3312b0ad-860a-454a-a1ee-d86a69e65c4b.html,,,,,, Vanadium carbide nitride,12069-91-9," A study via the oral route is available for vanadium carbide nitride. The NOAEL results in a discriminating dose of ≥ 1000 mg/kg bw/d VCN, corresponding to a NOAEL of ≥ 780 mg/kg bw/d V based on vanadium-content conversion. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8facd48a-7273-4a70-87ad-c8f1c40fefea/documents/IUC5-1ac8afdd-6e08-44ca-9e52-a9118d735c0b_0ce5e793-e8a4-4ae1-8482-a100281a5f5f.html,,,,,, Vanadium carbide nitride,12069-91-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8facd48a-7273-4a70-87ad-c8f1c40fefea/documents/IUC5-1ac8afdd-6e08-44ca-9e52-a9118d735c0b_0ce5e793-e8a4-4ae1-8482-a100281a5f5f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Vanadium carbide nitride,12069-91-9,"Vanadium carbide nitride is not acutely toxic via the oral, dermal, or inhalation route. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8facd48a-7273-4a70-87ad-c8f1c40fefea/documents/IUC5-748e61e2-8f77-4882-b04b-f0d1a48f21e2_0ce5e793-e8a4-4ae1-8482-a100281a5f5f.html,,,,,, Vanadium carbide nitride,12069-91-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8facd48a-7273-4a70-87ad-c8f1c40fefea/documents/IUC5-748e61e2-8f77-4882-b04b-f0d1a48f21e2_0ce5e793-e8a4-4ae1-8482-a100281a5f5f.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Vanadium dioxide,12036-21-4,"A comprehensive literature search was recently conducted for the vanadium category substances, to source relevant information for the hazard and risk assessment. For the group of the soluble vanadium substances, a limited number of studies is available, and the different experimental approaches lead to a variety of endpoints measured. Of the limited effects noted following oral exposure with soluble vanadium substances, it appears most likely that effects on haematological parameters are the most consistently reported among a number of investigators (Mountain et al 1953, Zaporowska et al. 1993, Scibior et al 2006, Scibior, 2005, NTP, 2002, NTP, 2023). Altogether, haematological effects have been found with a variety of different vanadium compounds including sodium metavanadate, vanadium pentoxide, and ammonium metavanadate supporting the use of this endpoint for risk assessment purposes. Furthermore, epithelial hyperplasia in the small intestine of rats and mice were observed after the administration of sodium metavanadate and vanadyl sulfate (NTP, 2023). Therefore, this endpoint should also be considered for risk assessment purposes.   Further information: Divanadium pentaoxide has been excluded from the soluble vanadium substances read-across group due to its legal classification. Thus, studies conducted with divanadium pentaoxide are reported for information purposes only. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b55e0997-3239-4a96-a86a-2bbf72c05409/documents/IUC5-3f932784-2252-454a-8e3a-4184cc3cae7b_865e11dd-1f97-45b3-8bde-441cadf2545b.html,,,,,, Vanadium dioxide,12036-21-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b55e0997-3239-4a96-a86a-2bbf72c05409/documents/IUC5-3f932784-2252-454a-8e3a-4184cc3cae7b_865e11dd-1f97-45b3-8bde-441cadf2545b.html,Repeated dose toxicity – local effects,inhalation,,22 mg/m3,, Vanadium dioxide,12036-21-4,"Acute oral toxicity: 300 mg/kg bw < LD50 (rats, female) < 2000 mg/kg bw (cut-off value: 500 mg/kg bw)(OECD 423 (2001); GLP compliant) Acute inhalation toxicity: LC50 (rats, 4 hours) > 5.05 mg/L air (actual concentration)(according to OECD 436 (2009); GLP compliant) Acute dermal toxicity: LD50 (rats) > 2500 mg/kg bw (according to OECD 402 (1987); GLP compliant)(read-across from vanadium trioxide) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b55e0997-3239-4a96-a86a-2bbf72c05409/documents/IUC5-ab982095-2467-433a-9334-96b12998a203_865e11dd-1f97-45b3-8bde-441cadf2545b.html,,,,,, Vanadium dioxide,12036-21-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b55e0997-3239-4a96-a86a-2bbf72c05409/documents/IUC5-ab982095-2467-433a-9334-96b12998a203_865e11dd-1f97-45b3-8bde-441cadf2545b.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, Vanadium oxide sulphate,27774-13-6,"Description of key information - soluble vanadium substances group (oral) A comprehensive literature search was recently conducted for the vanadium category substances, to source relevant information for the hazard and risk assessment. For the group of the soluble vanadium substances, a limited number of studies is available, and the different experimental approaches lead to a variety of endpoints measured. Of the limited effects noted following oral exposure with soluble vanadium substances, it appears most likely that effects on haematological parameters are the most consistently reported among a number of investigators (Mountain et al 1953, Zaporowska et al. 1993, Scibior et al 2006, Scibior, 2005, NTP, 2002, NTP, 2023). Altogether, haematological effects have been found with a variety of different vanadium compounds including sodium metavanadate, vanadium pentoxide, and ammonium metavanadate supporting the use of this endpoint for risk assessment purposes. Furthermore, epithelial hyperplasia in the small intestine of rats and mice were observed after the administration of sodium metavanadate and vanadyl sulfate (NTP, 2023). Therefore, this endpoint should also be considered for risk assessment purposes. Information on repeated dose toxicity following inhalation exposure to divanadium pentaoxide is available in a NTP study (k_NTP 2002) with exposure of male and female rats and mice to V2O5 over 16-days, 3-months and 2-years. Pulmonary reactivity to divanadium pentaoxide was also investigated following subchronic inhalation exposure in a non-human primate animal model. Data of the repeated-dose toxicity via the dermal route are not available for any vanadium substance. Following the HERAG guidance for metals and metal salts (see section 7.1.2 of the technical dossier: dermal absorption), negligible percutaneous uptake based on minimal penetration, i.e. a dermal absorption rate in the range of maximally 0.1 - 1.0 %, can be anticipated. Dermal absorption in this order of magnitude is not considered to be “significant”. Thus, regarding repeated-dose toxicity of vanadium substances, the dermal exposure route is not expected to be the most relevant. However, vanadium oxide sulphate has a potential for skin irritation based on effects observed in the in vitro skin irritation test. EBRC (2007) HERAG fact sheet - Assessment of occupational dermal exposure and dermal absorption for metals and inorganic metal compounds, EBRC Consulting GmbH, Hannover, Germany, August 2007, 49 pages.   Further information: Divanadium pentaoxide has been excluded from the soluble vanadium substances read-across group due to its legal classification. Thus, studies conducted with divanadium pentaoxide are reported for information purposes only. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba478e67-39cf-49a2-85a9-4433c600e4e9/documents/IUC5-7fd3b89d-0b8e-4baa-b5ce-f610a6fa1503_c545d71d-0bf1-48ba-884a-046f7765f8df.html,,,,,, Vanadium oxide sulphate,27774-13-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ba478e67-39cf-49a2-85a9-4433c600e4e9/documents/IUC5-7fd3b89d-0b8e-4baa-b5ce-f610a6fa1503_c545d71d-0bf1-48ba-884a-046f7765f8df.html,Repeated dose toxicity – local effects,inhalation,LOAEC,0.9 mg/m3,adverse effect observed,rat Vanadium oxide sulphate,27774-13-6, No reliable information available. No further testing required because vanadium oxide sulphate pentahydrate is classified as corrosive to skin. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ba478e67-39cf-49a2-85a9-4433c600e4e9/documents/IUC5-0ca433d6-fa77-42cc-b25c-792835a94157_c545d71d-0bf1-48ba-884a-046f7765f8df.html,,,,,, Vanadium tetrachloride,7632-51-1," In accordance with REACH Annex XI, section 2, testing is technically not feasible as a consequence of the properties of the substance (hydrolytically unstable substance and quasi-instantaneously degraded in contact with moist skin or mucous membranes to form Vanadium dioxide and hydrogen chloride).   And there are sufficient data on the breakdown products (vanadium dioxide n°CAS: 12036-21-4 and hydrogen chloride n°CAS: 9004-54-0) which were already registered in the frame of REACH. These breakdown substances are exempted to Registration following Annex V (Entry I) for this register dossier. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a39142b4-a4fb-4712-b051-ad9a81429290/documents/a5a7160e-5b6d-405f-b04e-2bf602b09f84_f9b34a43-167f-4e06-8be1-4122ad7ac607.html,,,,,, Vanadium tetrachloride,7632-51-1," VCl4 is not a stable vanadium chloride. Its decomposition is driven by heat, dissolved Cl2 concentration, humidity or light, following the first equation: VCl4 + H2O => VOCl2 + 4 HCL The dissolution reaction in water (body humidity...) is exothermic, instantaneous (half-life of VCl4 < 1 hour – VCl4 can be considered as a hydrolytically unstable substance), gives white fumes of HCl and the pH of the solution is < 2. Due this physico-chemical property (HCl generation) and the weight of evidence (industrial practice), VCl4 is considered as corrosive and test for acute toxicity are not performed for animal welfare considerations. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a39142b4-a4fb-4712-b051-ad9a81429290/documents/82bec434-6125-438e-8fbb-62623ddace23_f9b34a43-167f-4e06-8be1-4122ad7ac607.html,,,,,, Vanadium trichloride,7718-98-1," VCl3 is very hygroscopic and gives, in contact of humidity : VCl3 + H2O => VOCl + 2 HCL VOCl + 1/2Cl2 => VOCl2 The dissolution reaction in water is instantaneous (half-life of VCl3 < 1 hour – VCl3 can be considered as a hydrolytically unstable substance), gives white fumes of HCl and the pH of the solution is < 2. Due this physico-chemical property (HCl generation) and the weight of evidence (industrial practice), VCl3 is considered as corrosive and test for acute toxicity are not performed for animal welfare considerations ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5d8b4f34-dca6-484c-8736-69b923435f3b/documents/a3702596-78a9-4c26-8e8e-37951288d80c_b3badca0-069b-4f2c-9385-85dd4c585b70.html,,,,,, Vanadium trichloride oxide,7727-18-6," In accordance with REACH Annex XI, section 2, testing is technically not feasible as a consequence of the properties of the substance (hydrolytically unstable substance and quasi-instantaneously degraded in contact with moist skin or mucuous membranes to form Vanadium pentoxide and hydrogen chloride). There are sufficient data on the cleavage products (Vanadium pentoxide and hydrogen chloride were already registered in the frame of REACH) and the breakdown substance are exempted to Registration following Annex V (Entry I). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0b0e7629-5207-4165-9863-8d86851f2aff/documents/IUC5-db8f7826-ce91-4917-91f9-bf4af0a2cbfe_55777469-b0f2-4e79-95e5-1545b5ccfad5.html,,,,,, Vanadium trichloride oxide,7727-18-6," With the physico-chemical property (HCl generation) and the weight of evidence (industrial practice), VOCl3 is considered as corrosive and test for acute toxicity are not performed for animal welfare considerations. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0b0e7629-5207-4165-9863-8d86851f2aff/documents/IUC5-09f8eb9c-f57d-4183-8293-ce0919090725_55777469-b0f2-4e79-95e5-1545b5ccfad5.html,,,,,, Vanadyl pyrophosphate,58834-75-6,The No Observed Effect Level (NOEL) was considered to be 200 mg/kg/day. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c21d569-3026-4123-bcdf-1a9b9a1ea33f/documents/IUC5-42819b44-18a0-4394-84dc-44f7b05a6dee_b546572d-764a-42d7-b914-d9a2d252f902.html,,,,,, Vanadyl pyrophosphate,58834-75-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8c21d569-3026-4123-bcdf-1a9b9a1ea33f/documents/IUC5-42819b44-18a0-4394-84dc-44f7b05a6dee_b546572d-764a-42d7-b914-d9a2d252f902.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat Vanadyl pyrophosphate,58834-75-6,Acute toxicity:Oral - LD50 = 2171 mg/kg body weightDermal - LD50 = >2000mg/kg body weightInhalation - LC50 = > 5.83 mg/L air ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c21d569-3026-4123-bcdf-1a9b9a1ea33f/documents/IUC5-7e1b5d8c-8dd2-4be6-a8c6-040e50082523_b546572d-764a-42d7-b914-d9a2d252f902.html,,,,,, Vanadyl pyrophosphate,58834-75-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c21d569-3026-4123-bcdf-1a9b9a1ea33f/documents/IUC5-7e1b5d8c-8dd2-4be6-a8c6-040e50082523_b546572d-764a-42d7-b914-d9a2d252f902.html,,oral,LD50,"2,171 mg/kg bw",, Vanadyl pyrophosphate,58834-75-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c21d569-3026-4123-bcdf-1a9b9a1ea33f/documents/IUC5-7e1b5d8c-8dd2-4be6-a8c6-040e50082523_b546572d-764a-42d7-b914-d9a2d252f902.html,,dermal,LD50,"2,000 mg/kg bw",, Vanadyl pyrophosphate,58834-75-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c21d569-3026-4123-bcdf-1a9b9a1ea33f/documents/IUC5-7e1b5d8c-8dd2-4be6-a8c6-040e50082523_b546572d-764a-42d7-b914-d9a2d252f902.html,,inhalation,LC50,5.83 mg/m3,, Vinyl 2-ethylhexanoate,94-04-2,"Male and female rats were administered vehicle control item or 250, 500, or1000 mg/kg/day VEHA via oral gavage once daily. Vinyl 2-ethylhexanoate-relatedobservations in animals administered 1000 mg/kg/day included: nonadverse increasedincidence of ataxia in the first week; nonadverse decreased body weight gain; adversereduction in activity at Week 12; pronounced alterations in clinical chemistry andhematology endpoints of minimally lower total white blood cell count, minimally lowerplatelet count, decreased total protein concentration, higher cholesterol, higher highdensitylipoprotein, and higher triglyceride; microscopic findings of centrilobularhepatocyte hypertrophy (males), decreased lymphocytes (females), tubulardegeneration/atrophy of testes and luminal cell debris of the epididymis (males) withcorrelated decreased organ weights; and a significant decrease in sperm motility (males).For these reasons 1000 mg/kg/day was considered adverse when administered for13 weeks. Vinyl 2-ethylhexanoate-related observations in animals administered500 mg/kg/day included: nonadverse reduction in activity at Week 12, alterations inclinical chemistry and hematology endpoints seen at 1000 mg/kg/day but at a lowermagnitude, centrilobular hepatocyte hypertrophy in males, tubular degeneration/atrophyof the testes and luminal cell debris of the epididymis with no correlating organ weightchanges. Due to the mild severity of findings and the lack of an impact on the health andwellbeing of animals administered 500 mg/kg/day, effects for this dose were considerednonadverse when administered for 13 weeks. Thus, the no observed adverse effect level(NOAEL) is 500 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00865745-3311-471d-89a5-275f131e149b/documents/IUC5-251a5a65-4955-4fda-9768-b70d049f2ed4_1c4a4587-408c-4b29-92b1-cdc85b8fed08.html,,,,,, Vinyl 2-ethylhexanoate,94-04-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00865745-3311-471d-89a5-275f131e149b/documents/IUC5-251a5a65-4955-4fda-9768-b70d049f2ed4_1c4a4587-408c-4b29-92b1-cdc85b8fed08.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,500 mg/m3,, Vinyl 2-ethylhexanoate,94-04-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/00865745-3311-471d-89a5-275f131e149b/documents/IUC5-251a5a65-4955-4fda-9768-b70d049f2ed4_1c4a4587-408c-4b29-92b1-cdc85b8fed08.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,500 mg/kg bw/day,,rat Vinyl 2-ethylhexanoate,94-04-2,"Vinyl 2-ethylhexanoate is practically not toxic by the oral, dermal and inhalation routes of exposure in laboratory animals. The acute rat oral LD50 was 4.76 - 8.30 grams/kg of body weight. The acute rat 4 hr inhalation LC50 was greater than that of substantially saturated vapor. The acute dermal LD50 was > 13.92 grams/kg of body weight. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00865745-3311-471d-89a5-275f131e149b/documents/IUC5-fe185aed-56bd-46e5-b7a2-99cbdfdc7679_1c4a4587-408c-4b29-92b1-cdc85b8fed08.html,,,,,, Vinyl 2-ethylhexanoate,94-04-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00865745-3311-471d-89a5-275f131e149b/documents/IUC5-fe185aed-56bd-46e5-b7a2-99cbdfdc7679_1c4a4587-408c-4b29-92b1-cdc85b8fed08.html,,oral,LD50,"4,760 mg/kg bw",, Vinyl 2-ethylhexanoate,94-04-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/00865745-3311-471d-89a5-275f131e149b/documents/IUC5-fe185aed-56bd-46e5-b7a2-99cbdfdc7679_1c4a4587-408c-4b29-92b1-cdc85b8fed08.html,,dermal,LD50,"13,920 mg/kg bw",, "Vinyl 4-(1,1-dimethylethyl)benzoate",15484-80-7,Acute Oral Toxicity: REACH_LD50 >300 -< 2000 mg/kg bw | rat (female) | OECD 420 | #key study# ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73919605-f281-4ac4-8f0d-4bce9b2ebfbd/documents/1e5201a4-fe3e-419b-be22-2d4534b9b849_d00f546c-4665-46ac-887f-f7ca241119ae.html,,,,,, "Vinyl 4-(1,1-dimethylethyl)benzoate",15484-80-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/73919605-f281-4ac4-8f0d-4bce9b2ebfbd/documents/1e5201a4-fe3e-419b-be22-2d4534b9b849_d00f546c-4665-46ac-887f-f7ca241119ae.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, Vinyl chloroacetate,2549-51-1," The toxicity of VCA following short-term repeated oral exposure was assessed based on the toxicokinetics behaviour of the substance and the available information on the repeated-dose toxicity of its degradation products acetaldehyde and chloroacetic acid. The short-term repeated dose toxicity of acetaldehyde by the oral route was investigated and allowed to derive a NOAEL of 125 mg/kg bw/d (equivalent to an ingestion of 341.25 mg/kg bw/d of VCA). The repeated dose toxicity of chloroacetic acid by the oral route was investigated and a NOAEL of 3.5 mg/kg bw/d (equivalent to an ingestion of 4.48 mg/kg bw/d mg/kg bw/d of VCA) from a chronic toxicity study was identified. This value is considered as conservative in order to assess the short-term (4 weeks) repeated dose toxicity of VCA.  It can be expected from these results that the short-term repeated-dose toxicity of VCA following an oral exposure will be driven by its degradation product chloroacetic acid as it was shown to be more hazardous than acetaldehyde following a repeated exposure. Therefore the NOAEL of 4.48 mg/kg bw/d derived from a chronic toxicity study shall be used for the short-term repeated-dose toxicity of VCA. This value is conservative and considered to cover the adverse effects induced by the two main degradation products of VCA. In accordance with Annex VIII of REACH, Column 2, testing by the inhalation and dermal routes is only appropriate if exposure of humans via these routes is likely. Vinyl Chloroacetate is not made available on the EU market as a monomer and is imported already polymerised. Therefore no exposure of humans via the dermal and inhalation routes is expected. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67e322eb-3896-464a-9970-d74d9b9eec96/documents/c5ac289d-cae3-410f-95c2-3e5b9e941543_e796b7fd-04f7-44bf-bdef-640585a26434.html,,,,,, Vinyl chloroacetate,2549-51-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/67e322eb-3896-464a-9970-d74d9b9eec96/documents/c5ac289d-cae3-410f-95c2-3e5b9e941543_e796b7fd-04f7-44bf-bdef-640585a26434.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,4.48 mg/kg bw/day,,rat Vinyl chloroacetate,2549-51-1," The acute toxicity: oral of the test substance was determined during a GLP study performed in accordance with the OECD Guideline for Testing of Chemicals 423. Three female Sprague-Dawley rats were treated at 2000 mg/kg bw. Following this treatment, three male and three female rats received 200 mg/kg bw. Clinical signs and body weight development were monitored for 14 days following the administration of the test substance. All animals were subjected to gross necropsy. All animals treated with 2000 mg/kg bw and one female treated with 200 mg/kg were found dead during the day of dosing. Common signs of systemic toxicity noted in animals treated with 2000 mg/kg bw were hunched posture, ataxia, loss of righting reflex, decreased respiratory rate, laboured respiration, coma and pallor of the extremities. Common signs of systemic toxicity noted in animals treated with 200 mg/kg bw were hunched posture and lethargy with incidents or isolated incidents of diarrhoea, ataxia, decreased respiratory rate, laboured respiration and noisy respiration. Surviving animals showed expected gains in bodyweight over the study period and recovered one day after dosing. The acute oral median lethal dose (LD50) of the test item in rats was concluded to be 200 mg/kg body weight. As the majority of LD50 range falls into Acute Tox. Oral, Category 4 and the mean LD50 value would lie between 300 and 500 mg/kg bw, classification into category 4 was deemed applicable in accordance with Table 3.1.1 of Regulation (EC) No.1272/2008. No exposure of humans to the registered substance via inhalation is expected. Therefore it is not appropriate to perform testing on the substance by the inhalation, in accordance with Annex VIII of REACH, Column 2. The acute toxicity: dermal of the test substance was determined during a GLP study performed in accordance with the OECD Guideline for Testing of Chemicals 402. Five male and five female Sprague-Dawley rats were exposed to 2000 mg/kg bw of the test substance for 24h. Clinical signs and body weight development were monitored for 14 days following the administration of the test substance. All animals were subjected to gross necropsy. No deaths were observed. Dermal exposure to the test substance did not induce observable adverse effects. The acute oral median lethal dose (LD50) of the test item in rats was concluded to be 2000 mg/kg body weight. The test item did not meet the criteria for classification according to Regulation (EC) No.1272/2008 on the Classification, Labelling and Packaging of Substances and Mixtures. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67e322eb-3896-464a-9970-d74d9b9eec96/documents/68984b02-4411-43b3-a460-4fc5a58db808_e796b7fd-04f7-44bf-bdef-640585a26434.html,,,,,, Vinyl chloroacetate,2549-51-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67e322eb-3896-464a-9970-d74d9b9eec96/documents/68984b02-4411-43b3-a460-4fc5a58db808_e796b7fd-04f7-44bf-bdef-640585a26434.html,,oral,LD50,200 mg/kg bw,adverse effect observed, Vinyl chloroacetate,2549-51-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/67e322eb-3896-464a-9970-d74d9b9eec96/documents/68984b02-4411-43b3-a460-4fc5a58db808_e796b7fd-04f7-44bf-bdef-640585a26434.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Vinyl ethylene carbonate,4427-96-7,"28-day repeated oral toxicity (OECD 407):According to the results, the no-observed-adverse-effect-level (NOAEL) for test item in the repeated dose 28-day oral toxicity study in SD rats under the condition of the study was considered to be as following:Male rats: 30 mg/kg body weight/day;Female rats: 30 mg/kg body weight/day.The lowest-observed-adverse-effect-level (LOAEL) for test item in the repeated dose 28-day oral toxicity study in SD rats under the condition of the study was considered to be as following:Male rats: 100 mg/kg body weight/day;Female rats: 100 mg/kg body weight/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ef9b2d4-1036-4243-a90d-1a7e66ff925a/documents/dbe0ca4f-4cc0-4831-a164-1625958be077_a9e24f4f-e78f-4de0-be6c-f1817a16b581.html,,,,,, Vinyl ethylene carbonate,4427-96-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0ef9b2d4-1036-4243-a90d-1a7e66ff925a/documents/dbe0ca4f-4cc0-4831-a164-1625958be077_a9e24f4f-e78f-4de0-be6c-f1817a16b581.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat Vinyl ethylene carbonate,4427-96-7,Acute oral toxicity:The acute oral LD50 cut off in rats for the test item was 300 mg/kg b.w..Acute dermal toxicity:The acute dermal LD50 in rats for VEC was estimated to be more than 2000 mg/kg b.w. in female SD rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ef9b2d4-1036-4243-a90d-1a7e66ff925a/documents/217ada8a-6ea8-4d52-97e3-f8dea8b7e30a_a9e24f4f-e78f-4de0-be6c-f1817a16b581.html,,,,,, Vinyl ethylene carbonate,4427-96-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ef9b2d4-1036-4243-a90d-1a7e66ff925a/documents/217ada8a-6ea8-4d52-97e3-f8dea8b7e30a_a9e24f4f-e78f-4de0-be6c-f1817a16b581.html,,oral,LD50,50 mg/kg bw,adverse effect observed, Vinyl ethylene carbonate,4427-96-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0ef9b2d4-1036-4243-a90d-1a7e66ff925a/documents/217ada8a-6ea8-4d52-97e3-f8dea8b7e30a_a9e24f4f-e78f-4de0-be6c-f1817a16b581.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Vinyl laurate,2146-71-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da5aba3b-4c90-48d9-9aa9-954be75b8e42/documents/IUC5-966b6900-831e-47c2-b44b-c6d1cd5f0a32_db6210ea-99db-4dcb-8b95-f9ea62aecce7.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",, Vinyl laurate,2146-71-6,No toxicity was observed bot after oral and dermal adminbistration of vinyl laurate up to the highest requested dose of 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da5aba3b-4c90-48d9-9aa9-954be75b8e42/documents/IUC5-c02f777c-2cf5-494c-8216-930c2ba9a038_db6210ea-99db-4dcb-8b95-f9ea62aecce7.html,,,,,, Vinyl laurate,2146-71-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da5aba3b-4c90-48d9-9aa9-954be75b8e42/documents/IUC5-c02f777c-2cf5-494c-8216-930c2ba9a038_db6210ea-99db-4dcb-8b95-f9ea62aecce7.html,,oral,LD50,"2,000 mg/kg bw",, Vinyl laurate,2146-71-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da5aba3b-4c90-48d9-9aa9-954be75b8e42/documents/IUC5-c02f777c-2cf5-494c-8216-930c2ba9a038_db6210ea-99db-4dcb-8b95-f9ea62aecce7.html,,dermal,LD50,"2,000 mg/kg bw",, Vinylcyclohexane,695-12-5," The target substance Vinylcyclohexane was tested in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test (OECD 422). An increase, statistically significant in males, in the liver absolute and relative organ mean weight was recorded in high dose animals of both sexes treated with 800 mg/kg bw/day. Gross macroscopically examination showed a swollen liver in one high dose male. No other relevant treatment-related macroscopic changes were observed. Histopathologically, at 800 mg/kg bw/day, treatment-related changes were seen in the liver of some males and females characterized by minimal periportal and/or midzonal hepatocytic vacuolation of micro and macrovesicular form (fatty change like). Based on the results, the NOAEL is considered to be 300 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cba74adb-e9a6-416e-9293-acfcf4f1c349/documents/343c4581-8e4a-4d1a-8735-142e6ba10c03_dd0b79bd-f983-4b1e-9b84-9ff41c5fe0d6.html,,,,,, Vinylcyclohexane,695-12-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cba74adb-e9a6-416e-9293-acfcf4f1c349/documents/343c4581-8e4a-4d1a-8735-142e6ba10c03_dd0b79bd-f983-4b1e-9b84-9ff41c5fe0d6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,300 mg/kg bw/day,,rat Vinylcyclohexane,695-12-5," According to REACH Annex VII/VIII column 2 it is not necessary to conduct acute toxicity studies because the target substance is classified as corrosive to the skin. Nevertheless, available data from the literature is presented. Based on the results from an acute oral toxicity study, the oral LD50 can be considered to be greater than 2000 mg/kg bw in rat and mouse and the LC50 for rats can be considered to be 20.5 mg/mL and 13.7 mg/L for mice. Due to limited information presented regarding methodology, the available data cannot be used for classification and should be considered only as supporting data. According to the ECHA Guidance on information requirements and chemical safety assessment Part E: Risk Characterisation (Version 3, May 2016), substances classified for Skin Corrosion Category 1B are allocated to the moderate hazard band. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cba74adb-e9a6-416e-9293-acfcf4f1c349/documents/20137a95-f531-4b66-8d02-6707325994f5_dd0b79bd-f983-4b1e-9b84-9ff41c5fe0d6.html,,,,,, Vinylene carbonate,872-36-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): good ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2504c72-cc2c-4e7d-bbcb-14aabe3e8fc0/documents/abba59a2-7774-49e4-9058-c2d9a44fd35f_e808ac56-5455-4f80-a3e7-a7d62fd20b28.html,,,,,, Vinylene carbonate,872-36-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c2504c72-cc2c-4e7d-bbcb-14aabe3e8fc0/documents/abba59a2-7774-49e4-9058-c2d9a44fd35f_e808ac56-5455-4f80-a3e7-a7d62fd20b28.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,15 mg/kg bw/day,,rat Vinylene carbonate,872-36-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): good Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): good Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): good ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2504c72-cc2c-4e7d-bbcb-14aabe3e8fc0/documents/d59a58be-8994-4949-8cc7-a64da08435f2_e808ac56-5455-4f80-a3e7-a7d62fd20b28.html,,,,,, Vinylene carbonate,872-36-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2504c72-cc2c-4e7d-bbcb-14aabe3e8fc0/documents/d59a58be-8994-4949-8cc7-a64da08435f2_e808ac56-5455-4f80-a3e7-a7d62fd20b28.html,,oral,discriminating dose,300 mg/kg bw,adverse effect observed, Vinylene carbonate,872-36-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c2504c72-cc2c-4e7d-bbcb-14aabe3e8fc0/documents/d59a58be-8994-4949-8cc7-a64da08435f2_e808ac56-5455-4f80-a3e7-a7d62fd20b28.html,,dermal,discriminating dose,200 mg/kg bw,adverse effect observed, Vinylphosphonic acid,1746-03-8," In the combined repeated dose toxicity study with the reproduction/developmental toxicity screening test according to OECD TG 422, required in Annex VIII, Section 8.6.1 of REACH regulation, the test item did not cause signs of systemic toxicity in parental male and female Han: WIST rats at 100, 300 or 1000 mg/kg bw/day doses administered by oral gavage, either. A NOAEL of 1000 mg/kg bw/day was determined. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66709549-0bf3-4c1c-8f71-251f76c920e9/documents/5401e1de-4482-4c70-a3a0-ae438e2bd83b_61f627e3-232b-47a3-9c48-4984014450c6.html,,,,,, Vinylphosphonic acid,1746-03-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/66709549-0bf3-4c1c-8f71-251f76c920e9/documents/5401e1de-4482-4c70-a3a0-ae438e2bd83b_61f627e3-232b-47a3-9c48-4984014450c6.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Vinylphosphonic acid,1746-03-8, The oral LD50 value was determined to be > 2000 mg/kg bw in rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66709549-0bf3-4c1c-8f71-251f76c920e9/documents/8480e274-cc59-49e7-9546-22bf82dc9165_61f627e3-232b-47a3-9c48-4984014450c6.html,,,,,, Vinylphosphonic acid,1746-03-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/66709549-0bf3-4c1c-8f71-251f76c920e9/documents/8480e274-cc59-49e7-9546-22bf82dc9165_61f627e3-232b-47a3-9c48-4984014450c6.html,,oral,LD50,"2,980 mg/kg bw",adverse effect observed, Vinyltoluene,25013-15-4,"Subchronic NOAEC (rat, male/female): 60 ppm (289.57 mg/m3 based on molecular weight of 118 g/mol). (Similar to OECD 413, GLP) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): The key study was the only study available. The study was assigned a Klimisch score of 2 (Similar to OECD 413/GLP). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationSystemicEffects.EndpointConclusion.DataBaseQuality): The key study was the only study available. The study was assigned a Klimisch score of 2 (similar to OECD 413/GLP). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a1948ba-0341-4e91-8081-c3471615e37a/documents/IUC5-aa99b335-00e2-4621-b21a-44e483495d0a_51943994-a774-4a25-9139-aefb9f358d3b.html,,,,,, Vinyltoluene,25013-15-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2a1948ba-0341-4e91-8081-c3471615e37a/documents/IUC5-aa99b335-00e2-4621-b21a-44e483495d0a_51943994-a774-4a25-9139-aefb9f358d3b.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,289.57 mg/m3,,rat Vinyltoluene,25013-15-4,"Acute oral toxicity: LD50 (rat) = 2321.58 mg/kg bw (QSAR; 3-methylstyrene, CAS no. 100-80-1) LD50 (male rat) = 4000 mg/kg bw (No guideline; Vinyl toluene, CAS No. 25013-15-4) LD50 (rat) = 2255 mg/kg bw (No guideline; 4-Methylstyrene, CAS No. 622-97-9)   Acute inhalation toxicity: LC50 (male/female) = >5.02 mg/L (OECD 403/GLP) Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The quality of the database is high as there is QSAR data and 2 in vivo studies available. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The quality of the database is high as a guideline/GLP study is available. (OECD 403/GLP) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a1948ba-0341-4e91-8081-c3471615e37a/documents/19ed8890-cd39-4b3d-a04b-d6ca95fac6b4_51943994-a774-4a25-9139-aefb9f358d3b.html,,,,,, Vinyltoluene,25013-15-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a1948ba-0341-4e91-8081-c3471615e37a/documents/19ed8890-cd39-4b3d-a04b-d6ca95fac6b4_51943994-a774-4a25-9139-aefb9f358d3b.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Vinyltoluene,25013-15-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2a1948ba-0341-4e91-8081-c3471615e37a/documents/19ed8890-cd39-4b3d-a04b-d6ca95fac6b4_51943994-a774-4a25-9139-aefb9f358d3b.html,,inhalation,LC50,> 5.02 ,no adverse effect observed, "Violanthrene-5,10-dione",116-71-2, No treatment-related effects indicating local or systemic toxicity were observed in male or female animals at any of the dose levels investigated. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/561ffb57-10e4-43c7-9baf-b42f61c35765/documents/0847a224-5735-44e9-8133-be9d905b2be1_0b7136fd-017a-435b-8e4a-64db3a491776.html,,,,,, "Violanthrene-5,10-dione",116-71-2, No deaths were observed up to oral dose levels of 10000 mg/kg bw and dermal dose levels of 2500 mg/kg bw in rats or at inhalational exposure at saturation concentration for 8 hours. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/561ffb57-10e4-43c7-9baf-b42f61c35765/documents/a1343ef4-038e-4442-bbfd-e823373a4587_0b7136fd-017a-435b-8e4a-64db3a491776.html,,,,,, "Waste solids, lead silver anode",94552-05-3,"MeClas was used to automatically calculate the classification of the UVCB. MeClas is based on a database containing the human and environmental classification for each component relevant for classification. According to MeClas, the substance is classified for STOT-RE Cat. 1 (oral) and is not classified for inhalation or dermal. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b7697385-efed-45a7-994d-c63241e2418b/documents/b0cbf76d-ab9f-4aa9-933e-aaec5f765fc8_3f200a2a-8b67-4708-97f7-b59c378fc254.html,,,,,, "Waste solids, lead silver anode",94552-05-3,"According to MeClas, this substance is classified as acute toxic - inhalation Cat. 4. This substance is not classified for acute oral toxicity nor for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b7697385-efed-45a7-994d-c63241e2418b/documents/1bf1e098-7149-4bb2-8f61-8a46a6fd4f54_3f200a2a-8b67-4708-97f7-b59c378fc254.html,,,,,, "Waste solids, precious metal refining",98072-70-9,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents.     ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/33880390-3795-4acc-b57e-ba6ab648c145/documents/cbe09437-1281-401b-b4ff-19ebf117b417_7cb28d67-8f46-45bb-862a-a397dcebdbdf.html,,,,,, "Waste solids, precious metal refining",98072-70-9,The acute toxicity is driven by the characteristics of the individual UVCB constituents. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/33880390-3795-4acc-b57e-ba6ab648c145/documents/7bf2e922-c4a8-405c-be8d-e3da47a2177a_7cb28d67-8f46-45bb-862a-a397dcebdbdf.html,,,,,, "Wastes, lead battery reprocessing",94551-99-2,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/47d9f7ce-5e46-48c4-9c4f-8b90c1dc93c2/documents/IUC5-9ee49489-73ef-47d9-b331-3b74119a56c3_ac74fa8c-39e9-4158-99b9-c45f52802b0e.html,,,,,, "Wastes, lead battery reprocessing",94551-99-2,The acute toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47d9f7ce-5e46-48c4-9c4f-8b90c1dc93c2/documents/IUC5-dafe67e5-27b5-46d0-931e-9fd836b7d7ff_ac74fa8c-39e9-4158-99b9-c45f52802b0e.html,,,,,, "Wastewater, cadmium sulfate electrolytic, acid",69012-21-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8caba77b-f99f-4f46-a97d-328a92de2c6c/documents/04b8e8de-c5d2-4439-b804-af8ad09b6684_ffa832ee-9288-46a0-8c0a-94cf7139ef94.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.013 mg/m3,,"hamster, Syrian" "Wastewater, cadmium sulfate electrolytic, acid",69012-21-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8caba77b-f99f-4f46-a97d-328a92de2c6c/documents/04b8e8de-c5d2-4439-b804-af8ad09b6684_ffa832ee-9288-46a0-8c0a-94cf7139ef94.html,Chronic toxicity – systemic effects,oral,NOAEL,0.12 mg/kg bw/day,,monkey "Wastewater, cadmium sulfate electrolytic, acid",69012-21-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8caba77b-f99f-4f46-a97d-328a92de2c6c/documents/1a91dd27-a69b-4275-ad75-c156da648ad3_ffa832ee-9288-46a0-8c0a-94cf7139ef94.html,,oral,LD50,"2,330 mg/kg bw",, "Wastewater, cadmium sulfate electrolytic, acid",69012-21-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8caba77b-f99f-4f46-a97d-328a92de2c6c/documents/1a91dd27-a69b-4275-ad75-c156da648ad3_ffa832ee-9288-46a0-8c0a-94cf7139ef94.html,,inhalation,LC50,56 mg/m3,, "Wastewater, zinc sulfate electrolytic, acid",69012-24-4,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c1184727-2665-4281-aa48-99571a9ab6c6/documents/72fb98c5-bb09-4931-9798-5c1e73240b02_02fddce3-2d2a-4c63-979d-4d699c7febad.html,,,,,, "Wastewater, zinc sulfate electrolytic, acid",69012-24-4,The acute toxicity is driven by the characteristics of the individual UVCB constituents (assessment entity approach). Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c1184727-2665-4281-aa48-99571a9ab6c6/documents/279a9f6a-318a-4d5e-bde7-e4e14d920d2f_02fddce3-2d2a-4c63-979d-4d699c7febad.html,,,,,, Xanthan lyase,113573-69-6,"Xanthan lyase was not tested for acute toxicity, but two closely-related enzymes, pectate lyase and pectin lyase, were tested for acute toxicity. The acute toxicity of pectate lyase and pectin lyase was tested by administration by gavage as a single oral dose to one group of five male and five female rats followed by an observation period of 14 days. No signs of toxicity were observed among the rats treated with a single oral dose of pectate lyase corresponding 2447 mg enzyme concentrate dry matter/kg bodyweight (equivalent to 1526 mg aep/kg bodyweight) or a single dose of pectin lyase corresponding to 2218 mg enzyme concentrate dry matter/kg bodyweight (equivalent to 1428 mg aep/kg bodyweight). Based on the similarity of the tested enzymes with xanthan lyase - all belonging to the same enzyme sub-subclass - it can be concluded that similar results are expected for xanthan lyase. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Toxicological data has been generated within the enzyme producing industry during the last 40 years. Substantial documentation on the safety of the production strains have been generated, and the enzyme test materials are thoroughly characterized. High quality studies for all relevant endpoints, in vivo studies as well as in vitro studies, show that industrial enzymes from well-known and well-characterized production strains have very similar safety profiles across the catalytic activities. Read-across can therefore be applied for the majority of toxicological endpoints. The database can thus be considered of high quality. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d39b4c81-d729-4060-8984-ba7518b8fda6/documents/32141d59-448d-4743-a123-a469672c078f_36f7c303-f6ea-4cdb-b4b1-df39026f8d4d.html,,,,,, "Xanthylium, 3,6-bis(diethylamino)-9-[2-(ethoxycarbonyl)phenyl]-, molybdatetungstatephosphate",1326-04-1,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Guideline study ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d78340a2-947f-4deb-8c71-813e2eeb30e5/documents/2b59ed94-509b-4d66-b9d6-dc52fa472804_25c376bc-9a9b-4b7f-a1dc-62c9f38b30c2.html,,,,,, "Xanthylium, 3,6-bis(diethylamino)-9-[2-(ethoxycarbonyl)phenyl]-, molybdatetungstatephosphate",1326-04-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/d78340a2-947f-4deb-8c71-813e2eeb30e5/documents/2b59ed94-509b-4d66-b9d6-dc52fa472804_25c376bc-9a9b-4b7f-a1dc-62c9f38b30c2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Xanthylium, 3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethyl-, molybdatetungstatephosphate",85959-61-1," In a key study, the subject material was tested by oral gavage in male and female rats following OECD guideline 422 and following accepted GLP standards. It was concluded that the No-Observed-Adverse-Effect-Level (NOAEL) for systemic toxicity was 125 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f84638ed-3e35-4fc5-9a1f-06ec862c5398/documents/cb5470f8-4aa0-47c1-b8a6-dc3b8ca647f8_af14e08a-44f0-45d2-be5c-633fc4c519f9.html,,,,,, "Xanthylium, 3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethyl-, molybdatetungstatephosphate",85959-61-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f84638ed-3e35-4fc5-9a1f-06ec862c5398/documents/cb5470f8-4aa0-47c1-b8a6-dc3b8ca647f8_af14e08a-44f0-45d2-be5c-633fc4c519f9.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "Xanthylium, 3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethyl-, molybdatetungstatephosphate",85959-61-1,"The acute oral median lethal dose (LD 50) of the test item in the female Wistar strain rat was estimated to be >2000 mg/kg body weight (Globally Harmonized Classification System- Category 5). Category 5 has not been adopted by the EU according to Regulation (EC) No. 1272/2008 on classification, labelling and packaging of substances and mixtures.   The acute dermal median lethal dose (LD50) of the test item in the Wistar strain rat was found to be greater than 2000 mg/kg body weight.  The test item is not classified in accordance with GHS. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f84638ed-3e35-4fc5-9a1f-06ec862c5398/documents/IUC5-0b0cee1e-ff30-4cc0-b021-19236df89d71_af14e08a-44f0-45d2-be5c-633fc4c519f9.html,,,,,, "Xanthylium, 3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethyl-, molybdatetungstatephosphate",85959-61-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f84638ed-3e35-4fc5-9a1f-06ec862c5398/documents/IUC5-0b0cee1e-ff30-4cc0-b021-19236df89d71_af14e08a-44f0-45d2-be5c-633fc4c519f9.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "Xanthylium, 3,6-bis(ethylamino)-9-[2-(methoxycarbonyl)phenyl]-2,7-dimethyl-, molybdatetungstatephosphate",85959-61-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f84638ed-3e35-4fc5-9a1f-06ec862c5398/documents/IUC5-0b0cee1e-ff30-4cc0-b021-19236df89d71_af14e08a-44f0-45d2-be5c-633fc4c519f9.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, "Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, 4-[(5-chloro-2-hydroxyphenyl)azo]-4,5-dihydro-3-methyl-1-phenyl-3H-pyrazol-3-one 4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-1-phenyl-3H-pyrazol-3-one 3-[[1-[[(2-ethylhexyl)amino]carbonyl]-2-oxopropyl]azo]-2-hydroxy-5-nitrobenzoate cobaltate complexes",71888-93-2, Oral administration of the test material to rats at the extreme dose of 15000 mg/kg bw resulted in only 1 death. Animals showed only transient adverse effects. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a63fa5a0-8d8a-4836-9a96-98ca3b6b8e55/documents/IUC5-1524dd16-124e-4141-91f6-74e58be48b5b_7eefa2e4-6f59-4899-81b2-f3fdfeeca7d7.html,,,,,, "Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, 4-[(5-chloro-2-hydroxyphenyl)azo]-4,5-dihydro-3-methyl-1-phenyl-3H-pyrazol-3-one 4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-1-phenyl-3H-pyrazol-3-one 3-[[1-[[(2-ethylhexyl)amino]carbonyl]-2-oxopropyl]azo]-2-hydroxy-5-nitrobenzoate cobaltate complexes",71888-93-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a63fa5a0-8d8a-4836-9a96-98ca3b6b8e55/documents/IUC5-1524dd16-124e-4141-91f6-74e58be48b5b_7eefa2e4-6f59-4899-81b2-f3fdfeeca7d7.html,,oral,LD50,"15,000 mg/kg bw",no adverse effect observed, "Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, molybdatesilicate",62973-79-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b57c60f3-585b-49c9-8f3a-46c5280152d0/documents/f808d4c6-2684-42c8-9e4d-9c0d9f9a6db5_0ebba479-7afd-41a1-9444-6a4c8d634054.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, molybdatetungstatephosphate",1326-03-0," Acute Oral Toxicity:  In Acute oral toxicity,LD50 value was predicted based on OECD QSAR toolbox for target substance C.I. Pigment Violet 1 (1326-03-0) was estimated to be 8236.78 mg/kg bw,and for differentstudies available on the structurally similar read across substance C.I. Acid Red 52 (3520-42-1) was considered to be 10300 mg/kg bw and on Benzoic acid, 2-[4-(diethylamino)-2-hydroxybenzoyl]-, hexyl ester (302776-68-7) was considered to be >2000 mg/kg bw. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, C.I. Pigment Violet 1 (1326-03-0) cannot be classified for acute oral toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9dd77c73-8642-4cc3-b0b1-6fdb897bf299/documents/ebccd2cc-1253-47d0-8eca-a0278da16573_2cd739a9-6a11-4da6-b2d4-5d4c919c1aed.html,,,,,, "Xanthylium, 9-(2-carboxyphenyl)-3,6-bis(diethylamino)-, molybdatetungstatephosphate",1326-03-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9dd77c73-8642-4cc3-b0b1-6fdb897bf299/documents/ebccd2cc-1253-47d0-8eca-a0278da16573_2cd739a9-6a11-4da6-b2d4-5d4c919c1aed.html,,oral,LD50,"8,236.78 mg/kg bw",no adverse effect observed, "Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatesilicate",63022-06-0," In the Lumière Pink S.M. 8135N: Combined Repeated Dose Toxicity Study with the Reproduction/Developmental Toxicity Screening Study in the Wistar Rat by Oral Gavage Administration it has been concluded that, despite the histopathological findings observed in kidneys at 100 mg/kg (tubular basophilia), considering that they were of minimal to slight severity, partly consistent with a compensatory reparation and taking into account that there is no clear evidence that there is an affectation at functional level given the absence of biochemical effects at this dose, NOAEL can be considered as the dose of 100 mg/kg/day within the confines of this study.      ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f7c305d3-00f8-413d-887e-6fd0ed14964c/documents/19995c9c-9084-4cbc-a95c-0df625c89f8c_28bfc1c8-9f7c-456b-b33c-dce708d5e699.html,,,,,, "Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatesilicate",63022-06-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f7c305d3-00f8-413d-887e-6fd0ed14964c/documents/19995c9c-9084-4cbc-a95c-0df625c89f8c_28bfc1c8-9f7c-456b-b33c-dce708d5e699.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,100 mg/kg bw/day,,rat "Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatesilicate",63022-06-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f7c305d3-00f8-413d-887e-6fd0ed14964c/documents/264ac347-be90-49d2-80ca-81e19c9efbc0_28bfc1c8-9f7c-456b-b33c-dce708d5e699.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatetungstatephosphate",12224-98-5," Repeated dose toxicity: Oral Based on the prediction done using the OECD QSAR toolbox version 3.3 with log kow as the primary descriptor and considering the five closest read across substances, repeated dose toxicity was predicted for Pigment Red 81. The study assumed the use of male and female F344 rats in a study for 104 weeks. Since no significant treatment related effects were observed at the mentioned dose level, hence the No Observed Adverse Effect Level (NOAEL) for Pigment Red 81 is predicted to be 370.608337402 mg/Kg bw/day. Based on this value it can be concluded that the substance is considered to not toxic as per the criteria mentioned in CLP regulation. Repeated dose toxicity: Inhalation The test substance Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdate tungstate phosphate has very low vapor pressure (4.19E-011 Pa). Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur and therefore repeated dose toxicity via the inhalation route was considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value for Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatetungstatephosphate (as provided in section 7.2.3) is >2000 mg/kg body weight. The substance was also found to be not irritating and not sensitizing to the skin. Based on these considerations, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16d191c3-89c2-4e39-84b3-16f4e33defcc/documents/6e490845-a2f8-4d1f-bbea-95756e21294e_095fb421-e5f5-49e3-a9b2-6e39e4eb8635.html,,,,,, "Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatetungstatephosphate",12224-98-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/16d191c3-89c2-4e39-84b3-16f4e33defcc/documents/6e490845-a2f8-4d1f-bbea-95756e21294e_095fb421-e5f5-49e3-a9b2-6e39e4eb8635.html,Chronic toxicity – systemic effects,oral,NOAEL,370.608 mg/kg bw/day,,rat "Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatetungstatephosphate",12224-98-5," Acute Oral Toxicity:  Acute oral toxicity dose was predicted based on OECD QSAR toolbox for target substance Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatetungstatephosphate (12224-98-5) was estimated to be 5268.33 mg/kg bw for rat,and for different studies available on the functionally similar read across substance disodium 2-(3-oxo-6-oxidoxanthen-9-yl)benzoate (518-47-8) was considered to be 4740 mg/kg bw for mouse and for 2-(3-diethylamino-6-diethylazaniumylidene-xanthen-9-yl)-5-sulfo-benzenesulfonate (3520-42-1) was considered to be 2200 mg/kg bw for mouse. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw.Thus, comparing this value with the criteria of CLP regulation, Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatetungstatephosphate (12224-98-5) can be classified as category V of acute oral toxicity. Acute Inhalation Toxicity:  The test substance Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdate tungstate phosphate(12224-98-5) has very low vapor pressure (4.19E-011 Pa). Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be unlikely to occur and therefore repeated dose toxicity via the inhalation route was considered for waiver. Acute Dermal Toxicity: Acute dermal toxicity dose was predicted based on OECD QSAR toolbox for target substance Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatetungstatephosphate (12224-98-5) was estimated to be 4575.52 mg/kg bw for rat ,and for different studies available on structurally similar read across substance6-Dibutylamino-2-(2'-4'-Dimethylanilino)-3-Methylfluoran (36431-22-8)was considered to be >2000 mg/kg bwfor rat and for the closely related read across substance1-[2-(benzoyloxy)propoxy]propan-2-yl benzoate (27138-31-4) was considered to be >2000 mg/kg bw for rat.All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-,molybdatetungstatephosphate (12224-98-5)can be classified as category V of acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16d191c3-89c2-4e39-84b3-16f4e33defcc/documents/790c582e-07d4-4766-afb6-d9bfad4f9a9e_095fb421-e5f5-49e3-a9b2-6e39e4eb8635.html,,,,,, "Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatetungstatephosphate",12224-98-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16d191c3-89c2-4e39-84b3-16f4e33defcc/documents/790c582e-07d4-4766-afb6-d9bfad4f9a9e_095fb421-e5f5-49e3-a9b2-6e39e4eb8635.html,,oral,LD50,"5,268.33 mg/kg bw",no adverse effect observed, "Xanthylium, 9-[2-(ethoxycarbonyl)phenyl]-3,6-bis(ethylamino)-2,7-dimethyl-, molybdatetungstatephosphate",12224-98-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/16d191c3-89c2-4e39-84b3-16f4e33defcc/documents/790c582e-07d4-4766-afb6-d9bfad4f9a9e_095fb421-e5f5-49e3-a9b2-6e39e4eb8635.html,,dermal,LD50,"4,575.52 mg/kg bw",no adverse effect observed, "Xylanase, endo-1,4-",9025-57-4," The repeated dose oral toxicity of xylanase has been tested. The repeated dose inhalation and dermal toxicity were waived based on exposure considerations and the properties of the substance. The repeated dose oral toxicity was a subchronic toxicity test conducted according to OECD guideline 408 and in compliance with GLP. The conclusion was that the No Observed Adverse Effect Level (NOAEL) in rats was the highest dose level tested - 1051 mg/kg bw/day (based on TOS (Total Organic Solids)). Based on repeated dose oral study and weight of evidence, xylanase does not exert any repeated dose oral, dermal or inhalation toxicity to workers or consumers. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c402bff0-1914-48fa-94df-fed0a7207625/documents/f050f72e-2c8e-4415-8b01-9cc0be1ec791_a7b399a5-8ed8-437c-ad30-13892351270b.html,,,,,, "Xylanase, endo-1,4-",9025-57-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c402bff0-1914-48fa-94df-fed0a7207625/documents/f050f72e-2c8e-4415-8b01-9cc0be1ec791_a7b399a5-8ed8-437c-ad30-13892351270b.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,051 mg/kg bw/day",,rat "Xylanase, endo-1,4-",9025-57-4," The acute oral and inhalation toxicity of xylanase has been tested. The acute oral toxicity test and the acute inhalation toxicity test were short-term toxicity tests conducted according to OECD guidelines, and in compliance with GLP. No acute dermal toxicity test was conducted. The conclusion of the performed studies was that xylanase is non-toxic by acute oral and inhalation exposure (GHS Toxicity category V and IV, respectively). Based on weight of evidence, xylanase does not exert any acute dermal toxicity under foreseeable realistic exposures for both workers and consumers. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c402bff0-1914-48fa-94df-fed0a7207625/documents/5f53c467-55ae-448f-ad13-f0e93b91629b_a7b399a5-8ed8-437c-ad30-13892351270b.html,,,,,, "Xylanase, endo-1,4-",9025-57-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c402bff0-1914-48fa-94df-fed0a7207625/documents/5f53c467-55ae-448f-ad13-f0e93b91629b_a7b399a5-8ed8-437c-ad30-13892351270b.html,,oral,LD50,"2,102 mg/kg bw",no adverse effect observed, "Xylanase, endo-1,4-",9025-57-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c402bff0-1914-48fa-94df-fed0a7207625/documents/5f53c467-55ae-448f-ad13-f0e93b91629b_a7b399a5-8ed8-437c-ad30-13892351270b.html,,inhalation,LC50,"4,950 mg/m3",no adverse effect observed, "bis[2-hydroxy-N,N-bis(2-hydroxyethyl)ethanaminium] 7-{[4-(4-{[2-(cyanoamino)-4-hydroxy-6-oxo-1,6-dihydropyrimidin-5-yl]diazenyl}benzamido)-3-methoxyphenyl]diazenyl}naphthalene-1,3-disulfonate",115811-45-5,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Experimental study result. Study is performed under GLP according to OECD 407. The reliability is 1. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2bea84bf-af9f-44e3-bb08-f275b76a6809/documents/IUC5-ce661734-d6c4-4667-aa19-b5e6e59fabdc_8e12c3f7-cb88-42ff-94cc-77b9a90ee4d2.html,,,,,, "bis[2-hydroxy-N,N-bis(2-hydroxyethyl)ethanaminium] 7-{[4-(4-{[2-(cyanoamino)-4-hydroxy-6-oxo-1,6-dihydropyrimidin-5-yl]diazenyl}benzamido)-3-methoxyphenyl]diazenyl}naphthalene-1,3-disulfonate",115811-45-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2bea84bf-af9f-44e3-bb08-f275b76a6809/documents/IUC5-ce661734-d6c4-4667-aa19-b5e6e59fabdc_8e12c3f7-cb88-42ff-94cc-77b9a90ee4d2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,200 mg/kg bw/day,,rat "bis[2-hydroxy-N,N-bis(2-hydroxyethyl)ethanaminium] 7-{[4-(4-{[2-(cyanoamino)-4-hydroxy-6-oxo-1,6-dihydropyrimidin-5-yl]diazenyl}benzamido)-3-methoxyphenyl]diazenyl}naphthalene-1,3-disulfonate",115811-45-5,The LD50 oral of substance registered is greater than 2000 mg/kg bw. The LD50 dermal was greater than 2000 mg/kg bw. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bea84bf-af9f-44e3-bb08-f275b76a6809/documents/IUC5-0a6b2bed-7daf-4e0d-9567-5bfd27a36b58_8e12c3f7-cb88-42ff-94cc-77b9a90ee4d2.html,,,,,, "bis[2-hydroxy-N,N-bis(2-hydroxyethyl)ethanaminium] 7-{[4-(4-{[2-(cyanoamino)-4-hydroxy-6-oxo-1,6-dihydropyrimidin-5-yl]diazenyl}benzamido)-3-methoxyphenyl]diazenyl}naphthalene-1,3-disulfonate",115811-45-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bea84bf-af9f-44e3-bb08-f275b76a6809/documents/IUC5-0a6b2bed-7daf-4e0d-9567-5bfd27a36b58_8e12c3f7-cb88-42ff-94cc-77b9a90ee4d2.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "bis[2-hydroxy-N,N-bis(2-hydroxyethyl)ethanaminium] 7-{[4-(4-{[2-(cyanoamino)-4-hydroxy-6-oxo-1,6-dihydropyrimidin-5-yl]diazenyl}benzamido)-3-methoxyphenyl]diazenyl}naphthalene-1,3-disulfonate",115811-45-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2bea84bf-af9f-44e3-bb08-f275b76a6809/documents/IUC5-0a6b2bed-7daf-4e0d-9567-5bfd27a36b58_8e12c3f7-cb88-42ff-94cc-77b9a90ee4d2.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Ytterbium (III) oxide,1314-37-0," Repeated dose toxicity - oral The key study (Papineau, 2018) was performed according to OECD guideline 422 and conform GLP requirements. In this study, ytterbium oxide was administered by oral gavage to male and female Sprague-Dawley rats, starting 2 weeks before mating, during mating and (for females) throughout gestation and until day 13 post-partum, at the dose levels of 110, 330 or 1000 mg/kg bw/day. In this study, the NOAEL for parental systemic toxicity was considered to be higher than or equal to 1000 mg/kg bw/day based on the absence of adverse findings related to the test item at the highest dose level. Based on these results, the test substance is not classified as STOT RE. Repeated dose toxicity - inhalation/dermal No key studies were identified for repeated dose toxicity after inhalation or dermal exposure. A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (Column 2, Annex VIII, Section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation or dermal route of exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cad4b269-83e3-4ee4-a55c-b57662d65aa0/documents/de6a4e8e-a031-4992-81fe-a49d0ba227d7_d2806dab-2354-442c-a55d-f37005025579.html,,,,,, Ytterbium (III) oxide,1314-37-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cad4b269-83e3-4ee4-a55c-b57662d65aa0/documents/de6a4e8e-a031-4992-81fe-a49d0ba227d7_d2806dab-2354-442c-a55d-f37005025579.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Ytterbium (III) oxide,1314-37-0," Acute oral toxicity One reliable acute toxicity study via the oral route of administration is available. After single dosing of 2000 mg/kg to rats, the LD50 was established as greater than 2000 mg/kg bw (Di Manno, 2014; Klimisch 1). Based on these results, the test substance is considered not classified as acute oral toxicant. Acute toxicity via inhalation In a reliable acute inhalation toxicity study performed according to OECD guideline 403, no deaths occurred in a group of animals exposed to the concentration of 1.31 mg/L (maximum achievable concentration) for 4 hours (Tóth, 2017; Klimisch 1). The 4-h LC50 was therefore considered to be greater than 1.31 mg/L and the substance is thus not classified as acute toxicant via inhalation. Acute dermal toxicity The acute oral LD50 is greater than 2000 mg/kg bw and no systemic effects or macroscopic abnormalities were observed in the reliable study available for this endpoint. According to Annex VIII, column 2 of the REACH Regulation (revision May 2016), acute dermal toxicity can be waived if the substance under consideration is not classified as acute oral toxicant or as STOT SE, and no systemic effects have been observed in in vivo studies with dermal exposure. The latter criterion (in vivo skin sensitisation study) is also fulfilled. Moreover, in addition to the oral route of exposure, for substances other than gases, the information mentioned under REACH section 8.5.2 to 8.5.3 shall be provided for at least one other exposure route (REACH Regulation, column 2 adaptation of Annex VIII). For ytterbium oxide, a key study is available for the inhalatory route of exposure. Therefore, an acute dermal toxicity study should not be performed. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cad4b269-83e3-4ee4-a55c-b57662d65aa0/documents/fb8921ac-3ef1-4b28-bc98-e2ad2548230c_d2806dab-2354-442c-a55d-f37005025579.html,,,,,, Ytterbium (III) oxide,1314-37-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cad4b269-83e3-4ee4-a55c-b57662d65aa0/documents/fb8921ac-3ef1-4b28-bc98-e2ad2548230c_d2806dab-2354-442c-a55d-f37005025579.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Ytterbium (III) oxide,1314-37-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cad4b269-83e3-4ee4-a55c-b57662d65aa0/documents/fb8921ac-3ef1-4b28-bc98-e2ad2548230c_d2806dab-2354-442c-a55d-f37005025579.html,,inhalation,LC50,"1,310 mg/m3",no adverse effect observed, Ytterbium trifluoride,13760-80-0, The oral LD50 value in Wistar rats was established to exceed 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e91675f9-e261-473f-a47c-4b5add947839/documents/8cae884f-a81c-4013-b4c6-58e0c7543b9c_473c6cad-74ce-47f0-bf28-c2bad2732643.html,,,,,, Ytterbium trifluoride,13760-80-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e91675f9-e261-473f-a47c-4b5add947839/documents/8cae884f-a81c-4013-b4c6-58e0c7543b9c_473c6cad-74ce-47f0-bf28-c2bad2732643.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Yttrium,7440-65-5," No repeated dose toxicity study is available with the test substance yttrium metal. Therefore, read across is performed using a study from the related substance yttrium oxide. The read across justification is attached to IUCLID Section 13. Repeated dose toxicity - oral: A combined repeated dose toxicity study with reproduction/developmental toxicity screening has been performed with the related substance according to OECD 422 test guideline using the oral exposure route on Wistar rats. Under the conditions of this study, no adverse systemic effects were observed and the No Observed Effect Level (NOEL) in males and females was considered to be 1000 mg/kg/day for yttrium oxide. The substance is considered not to be classified as STOT RE according to the CLP Regulation. The same is assumed for yttrium metal. Repeated dose toxicity - dermal: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Repeated dose toxicity - inhalation: A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5937f439-8eae-49c4-a201-54c38ece9524/documents/8a0942b3-6d93-4905-8114-a0421f61b62b_c8f3bd3d-23ff-4d25-a839-e0a2610037e4.html,,,,,, Yttrium,7440-65-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/5937f439-8eae-49c4-a201-54c38ece9524/documents/8a0942b3-6d93-4905-8114-a0421f61b62b_c8f3bd3d-23ff-4d25-a839-e0a2610037e4.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Yttrium,7440-65-5," Acute Oral Toxicity One reliable acute toxicity study via the oral route of administration is available. After single dosing of 2000 mg/kg to rats, the LD50 was established as greater than 2000 mg/kg bw (Weisz, 2017). Based on this result, the test substance is considered not classified as an acute oral toxicant. Acute toxicity via inhalation No acute toxicity study via the inhalation route of exposure was available. Based on Column 2, Annex VIII, section 8.5 adaptation in the REACH Regulation, no acute inhalation toxicity study is to be performed as a key study via the oral route and the dermal route of exposure is available. Acute dermal toxicity No acute toxicity study via the dermal route of exposure was available. The study does not need to be conducted as the substance does not meet the criteria for classification as acute toxicant or STOT SE by oral route and no systemic effects have been observed in in vivo studies with dermal exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5937f439-8eae-49c4-a201-54c38ece9524/documents/74bbc51a-db0c-4fbc-863e-8c5972d460e1_c8f3bd3d-23ff-4d25-a839-e0a2610037e4.html,,,,,, Yttrium,7440-65-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5937f439-8eae-49c4-a201-54c38ece9524/documents/74bbc51a-db0c-4fbc-863e-8c5972d460e1_c8f3bd3d-23ff-4d25-a839-e0a2610037e4.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Yttrium borate phosphate vanadate, europium-doped",68784-82-7,"In an acute oral toxicity study in female rats, conducted in accordance with OECD 423 (2001), EU Method B.1 tris (2008), EPA OPPTS 870.1100 (2002) and according to GLP principles, a LD50 oral of >2000 mg/kg was determined. In an acute inhalation study in 5 male and 5 female rats, conducted in accordance with OECD 403 (2009) and according to GLP principles, a 4h-LC50 of >5.09 mg/L was determined. In an acute dermal toxicity study in 5 male and 5 female rats, performed in accordance with OECD 402 (1987), EU Method B.3 ( 2008), EPA OPPTS 870.1200 (1998) and according to GLP principles, a LD50 of >2000 mg/kg bw was determined. No mortalities occurred in these studies. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d7724fc-d2e7-4556-a6d6-7212490520bf/documents/IUC5-8d7f72b4-c72c-449d-ab9c-49ce07fc682b_c7f41dac-45be-4f32-bf49-4570e1fcca7a.html,,,,,, "Yttrium borate phosphate vanadate, europium-doped",68784-82-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d7724fc-d2e7-4556-a6d6-7212490520bf/documents/IUC5-8d7f72b4-c72c-449d-ab9c-49ce07fc682b_c7f41dac-45be-4f32-bf49-4570e1fcca7a.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Yttrium borate phosphate vanadate, europium-doped",68784-82-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d7724fc-d2e7-4556-a6d6-7212490520bf/documents/IUC5-8d7f72b4-c72c-449d-ab9c-49ce07fc682b_c7f41dac-45be-4f32-bf49-4570e1fcca7a.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Yttrium borate phosphate vanadate, europium-doped",68784-82-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7d7724fc-d2e7-4556-a6d6-7212490520bf/documents/IUC5-8d7f72b4-c72c-449d-ab9c-49ce07fc682b_c7f41dac-45be-4f32-bf49-4570e1fcca7a.html,,inhalation,LC50,"5,090 mg/m3",no adverse effect observed, Yttrium chloride hexahydrate,10361-92-9," Repeated dose toxicity - oral No reliable information has been identified on the oral repeated dose toxicity of yttrium trichloride. Therefore, the endpoint was covered using the results of the key combined repeated dose toxicity and screening reproduction/developmental toxicity test performed with yttrium trinitrate, i.e. an yttrium compound with similar water solubility as yttrium trichloride. This study was performed according to OECD guideline 422 (Rossiello, 2017; Klimisch 1) and conform GLP requirements. In this study, male and female rats were exposed to 0, 250, 500 and 1000 mg/kg bw/day yttrium trinitrate via their diet, during 32-33 days (males) or 41-44 days (females). No treatment-related effects indicating systemic toxicity were observed in male or female animals at any of the dose levels investigated. Based on these results, the NOAEL was concluded to be higher than or equal to 1000 mg/kg bw/day for males and females. This result is considered relevant for yttrium trichloride as well. The read across justification document is attached to IUCLID Section 13. Repeated dose toxicity - inhalation/dermal No key studies were identified for repeated dose toxicity after inhalation or dermal exposure. A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation or dermal route of exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7322d9b6-8dea-4723-b411-3049e8b91ff1/documents/311c8c1e-e948-4269-949b-bf45e3723f51_8ab147bd-2128-4b7e-b1cb-c2ca41b77111.html,,,,,, Yttrium chloride hexahydrate,10361-92-9," Acute oral toxicity The key acute oral toxicity study (Oroszlány; Klimisch 1) concluded that the LD50 for male and female Wistar rats was equal to or higher than 2000 mg/kg body weight, based on an experiment performed according to the acute toxic class method (OECD guideline 423). Acute dermal toxicity Since no reliable data are available for yttrium trichloride, the endpoint is covered using the key acute dermal toxicity study performed with the read across substance yttrium trinitrate (Salvador, 2015; Klimisch 1). This study identified an LD50 value greater than 2000 mg yttrium trinitrate/kg body weight in male and female Sprague-Dawley rats, according to OECD guideline 402. This result is considered relevant for yttrium trichloride too. Acute inhalation toxicity Based on Column 2, Annex VIII, section 8.5 adaptation in the REACH regulation, no acute inhalation toxicity study is to be performed as a key study via the oral route and the dermal route of exposure is available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7322d9b6-8dea-4723-b411-3049e8b91ff1/documents/62f9a25a-7007-4c00-88e7-7e044f91dbf4_8ab147bd-2128-4b7e-b1cb-c2ca41b77111.html,,,,,, "Yttrium oxide (Y2O3), europium-doped",68585-82-0,"A combined repeated dose toxicity study with reproduction/ developmental toxicity screening has been conducted with yttrium oxide according to OECD 422 test guideline using the oral exposure route with wistar rats. No adverse effects were observed and the NOAEL in males and females was considered to be >= 1000 mg/kg/day. A publication fully describes a 30 days repeated inhalation study with yttrium oxide in beagle dogs. A systemic NOAEL of > 12.65 mg/m3 was established based on the absence of relevant changes in organ weights, macroscopic observations at necropsy and histopathology at the tested concentration (above 12.65 mg/m3). A local LOAEL of 12.65 mg/m3 is established based on the inflammatory response to dust overload in lungs and bronchial lymph nodes. These results are read across to the registered substance.No dermal repeated dose toxicity study is available as inhalation exposure is more likely due to the small particle size of the substance. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64038c02-9f7e-4588-9942-1e989c7c7212/documents/4649254a-6c57-4b35-a4ca-e047e3f351ab_8e01510d-3f82-4d33-a3bc-4a705272f183.html,,,,,, "Yttrium oxide (Y2O3), europium-doped",68585-82-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64038c02-9f7e-4588-9942-1e989c7c7212/documents/4649254a-6c57-4b35-a4ca-e047e3f351ab_8e01510d-3f82-4d33-a3bc-4a705272f183.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Yttrium oxide (Y2O3), europium-doped",68585-82-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/64038c02-9f7e-4588-9942-1e989c7c7212/documents/4649254a-6c57-4b35-a4ca-e047e3f351ab_8e01510d-3f82-4d33-a3bc-4a705272f183.html,Repeated dose toxicity – local effects,inhalation,LOAEC,12.65 mg/m3,adverse effect observed,dog "Yttrium oxide (Y2O3), europium-doped",68585-82-0," Several acute oral studies are available both with yttrium oxide itself as well as with europium oxide itself. As all studies indicated an LD50 >2000 mg/kg no further studies were performed. No acute dermal toxicity is available as the inhalation exposure is more likely due to the small particle size of the substance. An acute inhalation toxicity study with yttrium oxide is available showing an LD50 >5.09 mg/L. These results are read-across to yttrium oxide, europium doped. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64038c02-9f7e-4588-9942-1e989c7c7212/documents/4b1d81e0-b7fe-4b6d-b49e-d9a6cecee6d1_8e01510d-3f82-4d33-a3bc-4a705272f183.html,,,,,, "Yttrium oxide (Y2O3), europium-doped",68585-82-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64038c02-9f7e-4588-9942-1e989c7c7212/documents/4b1d81e0-b7fe-4b6d-b49e-d9a6cecee6d1_8e01510d-3f82-4d33-a3bc-4a705272f183.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, "Yttrium oxide (Y2O3), europium-doped",68585-82-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/64038c02-9f7e-4588-9942-1e989c7c7212/documents/4b1d81e0-b7fe-4b6d-b49e-d9a6cecee6d1_8e01510d-3f82-4d33-a3bc-4a705272f183.html,,inhalation,LC50,"5,090 mg/m3",no adverse effect observed, Yttrium trinitrate,10361-93-0," Repeated dose toxicity - oral A key combined repeated dose toxicity and screening reproduction/developmental toxicity test was performed according to OECD guideline 422 (Rossiello, 2017; Klimisch 1) and conform GLP requirements. In this study, male and female rats were exposed to 0, 250, 500 and 1000 mg/kg bw/day yttrium trinitrate via their diet, during 32-33 days (males) or 41-44 days (females). No treatment-related effects indicating systemic toxicity were observed in male or female animals at any of the dose levels investigated. Based on these results, the NOAEL was concluded to be higher than or equal to 1000 mg/kg bw/day for males and females. The substance is considered not classified as STOT RE according to the CLP Regulation. Repeated dose toxicity - inhalation/dermal No key studies were identified for repeated dose toxicity after inhalation or dermal exposure. A key study is available for the oral route of exposure. According to the REACH Regulation, only one route of exposure should be tested for repeated dose toxicity (column 2, annex VIII, section 8.6.1). Therefore, it is not necessary to perform a repeated dose toxicity study via the inhalation or dermal route of exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b233f3bb-89c2-4ee7-993a-6a2cb5367023/documents/IUC5-6f7cc998-ddb7-46cb-8885-60a76d25658c_b76b5cb0-29cb-48da-811c-25ec0aa6d002.html,,,,,, Yttrium trinitrate,10361-93-0," Acute oral toxicity The key acute oral toxicity study (Shapiro, 1991a; Klimisch 1) identified an LD50 value for male and female Sprague-Dawley rats of 1650 mg/kg body weight, based on an experiment performed according to a method equivalent or similar to OECD guideline 401. Acute dermal toxicity The key acute dermal toxicity study (Salvador, 2015a; Klimisch 1) identified an LD50 value greater than 2000 mg/kg in male and female Sprague-Dawley rats, according to OECD guideline 402. Acute inhalation toxicity Based on Column 2, Annex VIII, section 8.5 adaptation in the REACH regulation, no acute inhalation toxicity study is to be performed as a key study via the oral route and the dermal route of exposure is available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b233f3bb-89c2-4ee7-993a-6a2cb5367023/documents/IUC5-ab841bbf-ef08-49bf-9680-7676452aa930_b76b5cb0-29cb-48da-811c-25ec0aa6d002.html,,,,,, Yttrium trinitrate,10361-93-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b233f3bb-89c2-4ee7-993a-6a2cb5367023/documents/IUC5-ab841bbf-ef08-49bf-9680-7676452aa930_b76b5cb0-29cb-48da-811c-25ec0aa6d002.html,,oral,LD50,"1,650 mg/kg bw",adverse effect observed, Yttrium zirconium oxide,64417-98-7,"No data are available on repeated dose toxicity of yttrium zirconium oxide. According to the read across approach (see IUCLID Section 13), the addition of yttrium oxide to the zirconium dioxide crystal lattice is not expected to change its toxicological properties. Therefore, it is assumed that yttrium zirconium oxide has a similar toxicological profile as zirconium dioxide. Consequently, the substance is not expected to cause any adverse effects after repeated exposure. The following data on repeated dose toxicity are included in this dossier:Repeated dose toxicity: oralTwo studies were used in a weight of evidence approach to cover this endpoint (same read across approach as in the zirconium dioxide dossier).Rossiello (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test via oral route in rats with the read across substance zirconium acetate according to OECD guideline 422 (GLP). A NOAEL of >=1000 mg/kg bw/day (expressed as zirconium acetate anhydrous) was derived. No adverse effects were reported in this study.No effects were reported after oral administration to rats during 17 weeks of zirconium basic carbonate (hydrated form) in the form of a moist paste containing 20.9% zirconium dioxide equivalent. The total intake of zirconium dioxide during the test period was 0, 0.9, 9 and 103.5 g. The equivalent NOAEL for zirconium dioxide was >= 3150-7080 mg/kg bw/day (Harrison et al., 1951).Repeated dose toxicity: inhalationNo effects were reported in any of the species studied (cat, dog, guinea pig, rabbit and rat) after inhalation of zirconium dioxide dust (NOAEC >= 100.8 mg ZrO2/m3 air in the 30 day study and NOAEC >= 15.4 mg ZrO2/m3 air in the 60 day study). The 30 and 60 days studies are used in a weight of evidence approach (Spiegl et al., 1956).Repeated dose toxicity: dermalNo reliable data were available for repeated dose toxicity, dermal route of exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e99b2e5-324a-42bb-a0d9-d67d7e7a61fd/documents/IUC5-683d14df-0a0c-45cf-967d-63a8e04b30b0_6f924f66-b602-44c4-9b27-f805e07e066a.html,,,,,, Yttrium zirconium oxide,64417-98-7,"Acute toxicity: oralThree reliable studies have been performed according to OECD 401 with three different batches of yttrium doped zirconia (Chemical Evaluation and Research Institute, 2001). The LD50 value derived after oral exposure to yttrium doped zirconia in the three studies is 2000 mg/kg bw.Acute toxicity: inhalationThe LC50 was higher than 4.3 mg/L (maximal technically achievable mean concentration) in male and female Crl:CD(SD) albino rats via nose-only inhalation exposure (dust aerosol of zirconium dioxide). Acute toxicity: dermalNo reliable data were available for acute toxicity via the dermal route of exposure. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e99b2e5-324a-42bb-a0d9-d67d7e7a61fd/documents/IUC5-4c850430-8544-435c-ac28-4908339946d5_6f924f66-b602-44c4-9b27-f805e07e066a.html,,,,,, Yttrium(3+) acetate,23363-14-6, Oral Under the conditions of this study the acute oral median lethal dose (LD50) of the test material in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8a145c3-9b36-4d0f-ab4b-d0b3cb7d24e1/documents/96d3d584-62c5-4336-aa0c-dfd77725822b_0341a300-fea4-41ed-9a19-454b2c90b137.html,,,,,, Yttrium(3+) acetate,23363-14-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b8a145c3-9b36-4d0f-ab4b-d0b3cb7d24e1/documents/96d3d584-62c5-4336-aa0c-dfd77725822b_0341a300-fea4-41ed-9a19-454b2c90b137.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Zinc 3,5,5-trimethylhexanoate",84682-03-1," No repeated dose toxicity study with zinc bis(3,5,5-trimethylhexanoate) is available, thus the repeated dose toxicity will be addressed with existing data on the individual moieties zinc and 3,5,5-trimethylhexanoic acid. According to the RAAF, neodecanoic acid will be considered in place of 3,5,5-trimethylhexanoic acid. In relevant and reliable repeated dose toxicity studies as well as supporting studies for both moieties of zinc bis(3,5,5-trimethylhexanoate), there were no toxicological findings reported that would justify a classification. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/da0a7b29-9641-416d-ad2a-730c647e2f41/documents/5bf9fe92-f420-4158-950a-948d13191611_75221704-6c8b-46ed-b966-cc5fbf959014.html,,,,,, "Zinc 3,5,5-trimethylhexanoate",84682-03-1," No acute toxicity studies with zinc bis(3,5,5-trimethylhexanoate) are available, thus the acute toxicity will be addressed with existing data on the dissociation products zinc and 3,5,5-trimethylhexanoic acid. According to the read-across assessment framework (RAAF), neodecanoic acid will be considered in place of 3,5,5-trimethylhexanoic acid. Signs of acute oral or acute dermal toxicity are not expected for zinc bis(3,5,5-trimethylhexanoate), since the moiety zinc, has not shown signs of acute oral toxicity (LD50 > 2000mg/kg) and acute dermal toxicity is considered to be low in view of the poor absorption by this route. Neodecanoic acid, as representative of 3,5,5-trimethylhexanoic acid, has not shown signs of acute oral or acute dermal toxicity in experimental testing (LD50 > 2000mg/kg). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/da0a7b29-9641-416d-ad2a-730c647e2f41/documents/5310f261-21aa-49a2-95b8-aebab589d239_75221704-6c8b-46ed-b966-cc5fbf959014.html,,,,,, "Zinc 3,5-bis(α-methylbenzyl)salicylate",53770-52-8,"There was no evidence of specific target organ toxicity in the two, oral repeated dose toxicity studies. In the 90 day study, general systemic toxicity was observed, which was characterised by lower body weight, food consumption and adverse clinical signs at doses of 100 mg/kg bw/day and above (overall LOAEL). For the mixture, For a mixture containing 80% zinc 3,5-bis(α-methylbenzyl)salicylate, the overall NOAEL was 10 mg/kg bw/day following 90 day exposure therefore, for zinc 3,5-bis(α-methylbenzyl)salicylate, the overall NOAEL was 8 mg/kg bw/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af23968c-75a3-457c-9be0-3964b15cac4a/documents/IUC5-642de7ca-4f2d-4719-864c-7358a01597cf_5cb1a046-ab51-4ffc-ae66-0510d4fcbd09.html,,,,,, "Zinc 3,5-bis(α-methylbenzyl)salicylate",53770-52-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/af23968c-75a3-457c-9be0-3964b15cac4a/documents/IUC5-642de7ca-4f2d-4719-864c-7358a01597cf_5cb1a046-ab51-4ffc-ae66-0510d4fcbd09.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,8 mg/kg bw/day,,rat "Zinc 3,5-bis(α-methylbenzyl)salicylate",53770-52-8,The acute oral LD50 is  1462 mg/kg bw.The acute dermal LD50 is > 2000 mg/kg bw ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af23968c-75a3-457c-9be0-3964b15cac4a/documents/IUC5-2e582c68-0341-4929-9ddb-45506669d9e2_5cb1a046-ab51-4ffc-ae66-0510d4fcbd09.html,,,,,, "Zinc 3,5-bis(α-methylbenzyl)salicylate",53770-52-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af23968c-75a3-457c-9be0-3964b15cac4a/documents/IUC5-2e582c68-0341-4929-9ddb-45506669d9e2_5cb1a046-ab51-4ffc-ae66-0510d4fcbd09.html,,oral,LD50,"1,462 mg/kg bw",adverse effect observed, "Zinc 3,5-bis(α-methylbenzyl)salicylate",53770-52-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/af23968c-75a3-457c-9be0-3964b15cac4a/documents/IUC5-2e582c68-0341-4929-9ddb-45506669d9e2_5cb1a046-ab51-4ffc-ae66-0510d4fcbd09.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Zinc acrylate,14643-87-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): NOAEL (rat) = 234 mg/kg bw/day (male) and 243 mg/kg bw/day (female) (i.e. ca. 53.5 mg Zn/kg bw/day or 170 mg zinc diacrylate/kg bw/day) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03685c1e-48d3-4b6f-91d2-a5f1ef06e647/documents/944e5be7-60a1-4a0f-8e65-4ffadacac12d_950dfd42-950c-499f-87d8-a45edbb46166.html,,,,,, Zinc acrylate,14643-87-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/03685c1e-48d3-4b6f-91d2-a5f1ef06e647/documents/944e5be7-60a1-4a0f-8e65-4ffadacac12d_950dfd42-950c-499f-87d8-a45edbb46166.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,170 mg/kg bw/day,,rat Zinc acrylate,14643-87-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03685c1e-48d3-4b6f-91d2-a5f1ef06e647/documents/6e6390e5-ad43-4491-bca4-6885d312e9ce_950dfd42-950c-499f-87d8-a45edbb46166.html,,oral,LD50,"1,071 mg/kg bw",adverse effect observed, Zinc acrylate,14643-87-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/03685c1e-48d3-4b6f-91d2-a5f1ef06e647/documents/6e6390e5-ad43-4491-bca4-6885d312e9ce_950dfd42-950c-499f-87d8-a45edbb46166.html,,dermal,LD50,"2,313 mg/kg bw",no adverse effect observed, Zinc bis(benzenesulphinate),24308-84-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/93199a78-2030-40be-b88a-d628e84e19a5/documents/ab41603a-fd71-478b-8979-3ba0f00438de_4c4cba02-7f75-42ff-91a8-80d0d235fee4.html,Short-term repeated dose toxicity – systemic effects,oral,LOAEL,50 mg/kg bw/day,,rat Zinc bis(dibenzyldithiocarbamate),14726-36-4," - In a GLP complaint oral repeated dose toxicity study, performed according to OECD 408, the no-observed-adverse-effect level (NOAEL) is placed at the highest level tested (1000 mg/kg body weight/day) because no adverse effects were observed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6708dc7-a112-4d52-a0e7-7bb2da4d1684/documents/IUC5-f0bcf37c-1ada-4708-b7c4-c4248417dc06_1a29faf0-44cf-483a-9907-24eb84004487.html,,,,,, Zinc bis(dibenzyldithiocarbamate),14726-36-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/e6708dc7-a112-4d52-a0e7-7bb2da4d1684/documents/IUC5-f0bcf37c-1ada-4708-b7c4-c4248417dc06_1a29faf0-44cf-483a-9907-24eb84004487.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Zinc bis(dibenzyldithiocarbamate),14726-36-4," No data on acute toxicity of zinc bis(dibenzyldithiocarbamate) (ZBEC) were available for assessment. However, based on the data from the structural analogue zinc bis(dibutyldithiocarbamate) (ZDBC), the acute toxicity of zinc bis(dibenzyldithiocarbamate) via oral and dermal routes of exposure is considered to be low, with LD50 > 2000 mg/kg bw/day. No data on inhalation route of exposure are available; however, the performance of a study is not warranted in accordance with Column 2 of REACH Annex X, as the data on two other routes of exposure are available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6708dc7-a112-4d52-a0e7-7bb2da4d1684/documents/IUC5-9637deb2-effc-472f-890f-a8c68e6ad7dd_1a29faf0-44cf-483a-9907-24eb84004487.html,,,,,, Zinc bis(dibenzyldithiocarbamate),14726-36-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6708dc7-a112-4d52-a0e7-7bb2da4d1684/documents/IUC5-9637deb2-effc-472f-890f-a8c68e6ad7dd_1a29faf0-44cf-483a-9907-24eb84004487.html,,oral,LD50,"5,000 mg/kg bw",no adverse effect observed, Zinc bis(dibenzyldithiocarbamate),14726-36-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e6708dc7-a112-4d52-a0e7-7bb2da4d1684/documents/IUC5-9637deb2-effc-472f-890f-a8c68e6ad7dd_1a29faf0-44cf-483a-9907-24eb84004487.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Zinc bis(diethyldithiocarbamate),14324-55-1," The NOAEL for general, systemic toxicity of the test substance was 10 mg/kg bw/d for male and female based on a sub-chronic repeated dose study according to OECD 408. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/68ce6f95-4498-4739-8576-84576aaa74f1/documents/IUC5-7bb51102-137e-44a0-9bfc-20d0b698b092_fc9e24c3-fcea-4ac8-aebb-1c0bdff0b677.html,,,,,, Zinc bis(diethyldithiocarbamate),14324-55-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/68ce6f95-4498-4739-8576-84576aaa74f1/documents/IUC5-7bb51102-137e-44a0-9bfc-20d0b698b092_fc9e24c3-fcea-4ac8-aebb-1c0bdff0b677.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,10 mg/kg bw/day,,rat Zinc bis(diethyldithiocarbamate),14324-55-1," Acute oral toxicity of zinc bis(diethyldithiocarbamate) (ZDEC) has been investigated in several studies with rats, all predating GLP and OECD guidelines. The lowest obtained LD50 value was 1960 mg/kg bw in male rats. Acute dermal toxicity study with rabbits resulted in LD50 > 2000 mg/kg bw. No data on acute inhalation toxicity were available; however, as sufficient data are available on the other two routes of exposure, the study is not warranted in accordance with Column 2 of REACH Annex VIII. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68ce6f95-4498-4739-8576-84576aaa74f1/documents/IUC5-7cafe630-4d98-4ce5-95fd-5b2ff0bd7e9c_fc9e24c3-fcea-4ac8-aebb-1c0bdff0b677.html,,,,,, Zinc bis(diethyldithiocarbamate),14324-55-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68ce6f95-4498-4739-8576-84576aaa74f1/documents/IUC5-7cafe630-4d98-4ce5-95fd-5b2ff0bd7e9c_fc9e24c3-fcea-4ac8-aebb-1c0bdff0b677.html,,oral,LD50,"1,960 mg/kg bw",adverse effect observed, Zinc bis(diethyldithiocarbamate),14324-55-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/68ce6f95-4498-4739-8576-84576aaa74f1/documents/IUC5-7cafe630-4d98-4ce5-95fd-5b2ff0bd7e9c_fc9e24c3-fcea-4ac8-aebb-1c0bdff0b677.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Zinc bis(dihydrogen phosphate),13598-37-3,"Animal data Oral: The repeated dose toxicity of the zinc category substances has been examined in a number of sub-chronic oral repeated dose toxictiy studies. The NOAEL for systemic effects of the zinc category substances was determined to be 25 mg Zn/kg bw/day, derived in an oral 90-day study with nano zinc oxide in rats. Inhalation: The repeated dose inhalation toxicity of micro and nano-ZnO has been examined respectively in a subacute (28 days) and two subchronic (90 days) inhalation studies. The lowest NOAEC was determined to be 0.47 mg/m³ (target concentration: 0.5 mg/m³) for micro ZnO. For nano-ZnO the BMCL10 was determined to be 0.971 mg/m³. Dermal: No adverse effects were observed in a 90-day repeated dose toxicity study via the dermal route with nano-ZnO. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityInhalationLocalEffects.EndpointConclusion.DataBaseQuality): guideline studies available ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8df8ad6e-89ca-4ad7-b98d-96abf24eefa9/documents/d3dbfe8d-29df-4047-bae7-35d291fdb315_819d1bf6-e4f4-4af9-81f1-62c37c890160.html,,,,,, Zinc bis(dihydrogen phosphate),13598-37-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8df8ad6e-89ca-4ad7-b98d-96abf24eefa9/documents/d3dbfe8d-29df-4047-bae7-35d291fdb315_819d1bf6-e4f4-4af9-81f1-62c37c890160.html,Repeated dose toxicity – local effects,inhalation,BMCL10,0.971 mg/m3,adverse effect observed,rat Zinc bis(dihydrogen phosphate),13598-37-3,"Assessment of the acute oral toxicity of zinc bis(dihydrogen phosphate) was studied in Wistar CRL/WI rats according to OECD guideline no 423 (Acute toxic Class Method) .The LD50 value was established to be within the range of >300 to <2000 mg/kg bw. According to OECD 423 test guideline and based on the LD50 cut-off values, the LD50 value was considered to be 1000mg/kg bw. There are no specific data for zinc bis(dihydrogen phosphate) available on which to evaluate for acute inhalation and dermal toxicity. Read-across towards soluble zinc chloride and zinc sulphate, indicates that zinc bis(dihydrogen phosphate) is of very low acute inhalation and dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8df8ad6e-89ca-4ad7-b98d-96abf24eefa9/documents/IUC5-5c3bbcba-0207-4631-8921-789a859b1e82_819d1bf6-e4f4-4af9-81f1-62c37c890160.html,,,,,, Zinc bis(dihydrogen phosphate),13598-37-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8df8ad6e-89ca-4ad7-b98d-96abf24eefa9/documents/IUC5-5c3bbcba-0207-4631-8921-789a859b1e82_819d1bf6-e4f4-4af9-81f1-62c37c890160.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, Zinc bis(dihydrogen phosphate),13598-37-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8df8ad6e-89ca-4ad7-b98d-96abf24eefa9/documents/IUC5-5c3bbcba-0207-4631-8921-789a859b1e82_819d1bf6-e4f4-4af9-81f1-62c37c890160.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, Zinc bis(dipentyldithiocarbamate),15337-18-5," In a combined repeat dose toxicity study (OECD 422), oral administration of the test item to parental Sprague Dawley (Crl:CD(SD)) rats at dose levels of 28, 85 or 250 mg/kg/day for five weeks to males and for two weeks before pairing, throughout gestation and up to Day 14 of lactation in females was well-tolerated in the adult animals with no treatment related adverse effects observed. The no-observed-adverse-effect-level (NOAEL) for systemic toxicity and for reproductive/developmental toxicity of the test item was considered to be 250 mg/kg/day, the highest tolerable dose tested. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eea76b05-f2fc-45fa-a08f-e975231740f5/documents/ae8d6bfc-28bf-450c-992d-06c2efe3066e_ef2e2b7c-072f-4487-9106-dfd2761b6a6c.html,,,,,, Zinc bis(dipentyldithiocarbamate),15337-18-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/eea76b05-f2fc-45fa-a08f-e975231740f5/documents/ae8d6bfc-28bf-450c-992d-06c2efe3066e_ef2e2b7c-072f-4487-9106-dfd2761b6a6c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat Zinc bis(dipentyldithiocarbamate),15337-18-5," Under the conditions of the study, the acute oral median lethal dose (LD50) of the test item in the female Wistar strain rat was estimated to be greater than 2000 mg/kg body weight (Globally Harmonized Classification System: Unclassified). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eea76b05-f2fc-45fa-a08f-e975231740f5/documents/dba21b0b-5a9e-49e6-8c03-b9f16f710f5c_ef2e2b7c-072f-4487-9106-dfd2761b6a6c.html,,,,,, Zinc bis(dipentyldithiocarbamate),15337-18-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eea76b05-f2fc-45fa-a08f-e975231740f5/documents/dba21b0b-5a9e-49e6-8c03-b9f16f710f5c_ef2e2b7c-072f-4487-9106-dfd2761b6a6c.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Zinc bis(N-ethyl-N-phenyldithiocarbamate),14634-93-6," There is no reliable information available. In an subchronic/chronic study with insufficient reported methodology and results (original paper in Russian language, Yalkut, 1971) 10 rats each (no information of strain and sex) received zinc ethylphenyl dithiocarbamate by gavage 6 times weekly in doses of 500 mg/kg bw for 1.5 months, 100 or 10 mg/kg bw for 4 months and 1 mg/kg bw  for 10 months. After a subchronic oral administration of 500 mg/kg bw of zinc ethylphenyldithiocarbamate to rats for 1.5 months some cases of deaths occurred. A dosage of 100 mg/kg bw or 10 mg/kg bw changes in the haemogram, the prothrombin time, and the cytochrome oxidase were observed. Histopathological effects on the liver, lung and kidneys were detected. The oral administration of 1 mg/kg bw over 10 months revealed no effects. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/94be2b95-d6b2-4740-b6af-e8fdceb29dd1/documents/194770e3-42f7-4901-a4d6-029e05f7b881_aad80a25-28fc-4b47-873f-64a5f2d70943.html,,,,,, Zinc bis(N-ethyl-N-phenyldithiocarbamate),14634-93-6," In an acute oral toxicity study the test substance was given as a 40% (w/v) suspension in propylene glycol to a group of ten male and ten female rats in one single dose of 25 ml/kg body weight.  The rats were observed for signs of intoxication during a 14-day period. At the end of the observation period autopsies were carried out on the survivors. Four male and 1 female rats died. The LD50 is > 10000 mg/kg bw. No acute inhalation or dermal toxicity studies are available. According to Commission Regulation (EU) 2016/863 of May 2016, (point 8.5 of Annex VIII) for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. Based on the physicochemical data (vapour pressure of the substance is  of 1.0E-4 Pa at 50°C (measured), water solubility of  0.07 mg/l at 20 °C and the log Kow of 3.4 at 20 °C testing by dermal route seems appropriate. According to Commission Regulation (EU) 2016/863 of May 2016 acute toxicity testing by the dermal route (Annex VII, point 8.5.3., column 2) ‘does not need to be conducted if the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure’.  The registered substance conforms with the requirements given above. Therefore, it can be concluded for acute dermal toxicity that the available information is conclusive for non-classification. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94be2b95-d6b2-4740-b6af-e8fdceb29dd1/documents/177191fb-7b11-4c95-ade2-c32de3c9753a_aad80a25-28fc-4b47-873f-64a5f2d70943.html,,,,,, Zinc bis(N-ethyl-N-phenyldithiocarbamate),14634-93-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/94be2b95-d6b2-4740-b6af-e8fdceb29dd1/documents/177191fb-7b11-4c95-ade2-c32de3c9753a_aad80a25-28fc-4b47-873f-64a5f2d70943.html,,oral,LD50,"10,000 mg/kg bw",no adverse effect observed, "Zinc bis(O,O-diisooctyl) bis(dithiophosphate)",28629-66-5,"Repeat dose oral toxicity data is not available for EC 249-109-7, but an OECD 407 study is available for an analogous substance and suitable for read across. NOAEL was 125 mg/kg/day for systemic toxicity. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97e3cea2-3a96-4490-acde-826d1080a4a4/documents/IUC5-2a9333b8-e19e-4241-a5a3-eb8a90523c6e_67e01848-4868-4ba9-8818-5467f1a844d0.html,,,,,, "Zinc bis(O,O-diisooctyl) bis(dithiophosphate)",28629-66-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97e3cea2-3a96-4490-acde-826d1080a4a4/documents/IUC5-2a9333b8-e19e-4241-a5a3-eb8a90523c6e_67e01848-4868-4ba9-8818-5467f1a844d0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "Zinc bis(O,O-diisooctyl) bis(dithiophosphate)",28629-66-5,The test material is not acutely toxic. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97e3cea2-3a96-4490-acde-826d1080a4a4/documents/IUC5-ebc2158a-d579-453e-aa13-6b78142202c3_67e01848-4868-4ba9-8818-5467f1a844d0.html,,,,,, "Zinc bis(O,O-diisooctyl) bis(dithiophosphate)",28629-66-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97e3cea2-3a96-4490-acde-826d1080a4a4/documents/IUC5-ebc2158a-d579-453e-aa13-6b78142202c3_67e01848-4868-4ba9-8818-5467f1a844d0.html,,oral,LD50,"3,200 mg/kg bw",, "Zinc bis(O,O-diisooctyl) bis(dithiophosphate)",28629-66-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97e3cea2-3a96-4490-acde-826d1080a4a4/documents/IUC5-ebc2158a-d579-453e-aa13-6b78142202c3_67e01848-4868-4ba9-8818-5467f1a844d0.html,,dermal,LD50,"5,000 mg/kg bw",, Zinc bis[12-hydroxyoctadecanoate],35674-68-1,"The oral NOAEL of 0.83 mg Zn/kg bw/day (recalculated from the NOAEL of 50 mg Zn/day for a 60 kg human being), derived from a 10 week oral human volunteer study on zinc gluconate will be used as the starting point for deriving DNELs for worker and general population. NOAELs for zinc exposure via the dermal or inhalatory route can be estimated by taking into account the bioavailability of zinc via the different exposure routes (for details see section 5.1 of Appendix 1 of the CSR). By zinc content correction, these data are read-across to zinc bis[12-hydroxyoctadecanoate]. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/964252ab-3d13-4297-b3bb-9cc93279d259/documents/IUC5-84efbc90-6f08-4880-85c7-554818b8fa3c_9cbc1730-563e-44d4-9d90-5501b9104f27.html,,,,,, Zinc bis[12-hydroxyoctadecanoate],35674-68-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/964252ab-3d13-4297-b3bb-9cc93279d259/documents/IUC5-84efbc90-6f08-4880-85c7-554818b8fa3c_9cbc1730-563e-44d4-9d90-5501b9104f27.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,8.3 mg/kg bw/day,,"other:human data, NOEAL is derived from dietary supplement studies on zinc gluconate and recalculated to zinc bis[12-hydroxyoctadecanoate] based on zinc content" Zinc bis[12-hydroxyoctadecanoate],35674-68-1,"The slightly soluble and insoluble zinc compounds (i.e., zinc oxide, zinc hydroxide, zinc phosphate, zinc carbonate, zinc metal, zinc sulphide as well as zinc bis[12-hydroxyoctadecanoate]) are of low acute, dermal and inhalation toxicity not requiring a classification for acute toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/964252ab-3d13-4297-b3bb-9cc93279d259/documents/IUC5-f88773b6-98bf-4a4c-a2f0-40ca43fb9e73_9cbc1730-563e-44d4-9d90-5501b9104f27.html,,,,,, Zinc bis[12-hydroxyoctadecanoate],35674-68-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/964252ab-3d13-4297-b3bb-9cc93279d259/documents/IUC5-f88773b6-98bf-4a4c-a2f0-40ca43fb9e73_9cbc1730-563e-44d4-9d90-5501b9104f27.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Zinc bis[12-hydroxyoctadecanoate],35674-68-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/964252ab-3d13-4297-b3bb-9cc93279d259/documents/IUC5-f88773b6-98bf-4a4c-a2f0-40ca43fb9e73_9cbc1730-563e-44d4-9d90-5501b9104f27.html,,inhalation,discriminating conc.,"50,000 mg/m3",no adverse effect observed, Zinc bis[bis(tetrapropylenephenyl)] bis(hydrogen dithiophosphate),11059-65-7,"A GLP compliant repeat dose oral gavage study in rats according to OECD 408. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): K1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05d00b50-703a-4971-96a2-ce924d1efe5b/documents/27c229d4-7cf4-4492-b653-7928574077f5_b7462384-edfb-433f-b709-ff7159224af0.html,,,,,, Zinc bis[bis(tetrapropylenephenyl)] bis(hydrogen dithiophosphate),11059-65-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/05d00b50-703a-4971-96a2-ce924d1efe5b/documents/27c229d4-7cf4-4492-b653-7928574077f5_b7462384-edfb-433f-b709-ff7159224af0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,716 mg/kg bw/day,,rat Zinc bis[bis(tetrapropylenephenyl)] bis(hydrogen dithiophosphate),11059-65-7,The test material is not acutely toxic. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05d00b50-703a-4971-96a2-ce924d1efe5b/documents/b0e3c1a1-13ce-49d7-a9d0-74885e337d0d_b7462384-edfb-433f-b709-ff7159224af0.html,,,,,, Zinc bis[bis(tetrapropylenephenyl)] bis(hydrogen dithiophosphate),11059-65-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05d00b50-703a-4971-96a2-ce924d1efe5b/documents/b0e3c1a1-13ce-49d7-a9d0-74885e337d0d_b7462384-edfb-433f-b709-ff7159224af0.html,,oral,LD50,"10,000 mg/kg bw",, Zinc bis[bis(tetrapropylenephenyl)] bis(hydrogen dithiophosphate),11059-65-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/05d00b50-703a-4971-96a2-ce924d1efe5b/documents/b0e3c1a1-13ce-49d7-a9d0-74885e337d0d_b7462384-edfb-433f-b709-ff7159224af0.html,,dermal,LD50,"25,600 mg/kg bw",, Zinc bis[O-(2-ethylhexyl)] bis[O-(isobutyl)] bis(dithiophosphate),26566-95-0," A 28 day study was available for an analogue substance suitable for read across (EC#224-235-5):The oral administration of the test material to rats by gavage, at a maximum dose level of 500 mg/kg/day for 28 days, resulted in adverse, treatment-related changes at 500 and 250 mg/kg/day. There were no treatment-related changes detected in the parameters measured among animals of either sex treated with 125 mg/kg/d. The NOAEL for systemic toxicity was therefore considered to be 125 mg/kg/day. 90 day study: A test proposal has been submitted for a category of substances of which this substance is a member. Multiple category members will be tested in a comprehensive intelligent testing strategy. Therefore, the read across to this substance will be based on multiple substances. See section 13 for category justification and test proposal. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ae894279-13a7-4643-91d3-b75fe859daed/documents/IUC5-92211940-8119-4817-989a-d28857b708b0_2d344e6c-402e-4bf8-b418-a425f0d0435f.html,,,,,, Zinc bis[O-(2-ethylhexyl)] bis[O-(isobutyl)] bis(dithiophosphate),26566-95-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/ae894279-13a7-4643-91d3-b75fe859daed/documents/IUC5-92211940-8119-4817-989a-d28857b708b0_2d344e6c-402e-4bf8-b418-a425f0d0435f.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Zinc bis[O-(2-ethylhexyl)] bis[O-(isobutyl)] bis(dithiophosphate),26566-95-0,"Oral: An analogue substance suitable for read across does not show evidence of toxicity via the oral route of exposure in animals when tested in accordance with OECD Guideline 401. The oral LD50 is 3400 mg/kg in male rats. At doses below 2900 mg/kg, no toxicity was observed in male or female animals. Therefore, for calculation of the Acute Oral DNEL, the value 2900 mg/kg was selected.Dermal: This substance shows minimal evidence of toxicity via the dermal route of exposure in animals when tested in accordance with OECD Guideline 402. The dermal LD50 is greater than 5000 mg/kg in male rabbits. Therefore, for calculation of the Acute Dermal DNEL, the value 5000 mg/kg was selected.Inhalation: Substance has a very low volatility (< 0.1 Pa at 20oC) therefore testing is not necessary. Since no Inhalation data are available for this substance, the value used to calculate the Acute Oral DNEL is also used to calculate the Acute Inhalation DNEL. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae894279-13a7-4643-91d3-b75fe859daed/documents/IUC5-74a4dcdb-de89-4bb0-9230-22b3418deded_2d344e6c-402e-4bf8-b418-a425f0d0435f.html,,,,,, Zinc bis[O-(2-ethylhexyl)] bis[O-(isobutyl)] bis(dithiophosphate),26566-95-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae894279-13a7-4643-91d3-b75fe859daed/documents/IUC5-74a4dcdb-de89-4bb0-9230-22b3418deded_2d344e6c-402e-4bf8-b418-a425f0d0435f.html,,oral,LD50,"2,900 mg/kg bw",, Zinc bis[O-(2-ethylhexyl)] bis[O-(isobutyl)] bis(dithiophosphate),26566-95-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/ae894279-13a7-4643-91d3-b75fe859daed/documents/IUC5-74a4dcdb-de89-4bb0-9230-22b3418deded_2d344e6c-402e-4bf8-b418-a425f0d0435f.html,,dermal,LD50,"5,000 mg/kg bw",, Zinc bis[O-(6-methylheptyl)] bis[O-(sec-butyl)] bis(dithiophosphate),93819-94-4,"A subchronic repeat dose oral study is available on the substance which concludes a NOAEL of 6000ppm. A repeat dose dermal toxicity data is available which provides a LOAEL of 70mg/kg bw/day. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): 1 ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2011571c-6842-455a-81c6-c3f36ccb240f/documents/IUC5-2e65d0e7-8370-40c0-a09c-3981de1cc2b0_bdb70046-7ce4-499f-bfe1-6ecadc35dbee.html,,,,,, Zinc bis[O-(6-methylheptyl)] bis[O-(sec-butyl)] bis(dithiophosphate),93819-94-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2011571c-6842-455a-81c6-c3f36ccb240f/documents/IUC5-2e65d0e7-8370-40c0-a09c-3981de1cc2b0_bdb70046-7ce4-499f-bfe1-6ecadc35dbee.html,Short-term repeated dose toxicity – systemic effects,dermal,LOAEL,70 mg/kg bw/day,,rabbit Zinc bis[O-(6-methylheptyl)] bis[O-(sec-butyl)] bis(dithiophosphate),93819-94-4,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/2011571c-6842-455a-81c6-c3f36ccb240f/documents/IUC5-2e65d0e7-8370-40c0-a09c-3981de1cc2b0_bdb70046-7ce4-499f-bfe1-6ecadc35dbee.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,336.7 mg/kg bw/day,,rat Zinc bis[O-(6-methylheptyl)] bis[O-(sec-butyl)] bis(dithiophosphate),93819-94-4,"As per test results on the material itself, as well as read-across from structurally similar ZDDPs, the test material is not acutely toxic. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2011571c-6842-455a-81c6-c3f36ccb240f/documents/IUC5-e9de0b02-286e-4896-85a1-1562845c3c37_bdb70046-7ce4-499f-bfe1-6ecadc35dbee.html,,,,,, Zinc bis[O-(6-methylheptyl)] bis[O-(sec-butyl)] bis(dithiophosphate),93819-94-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2011571c-6842-455a-81c6-c3f36ccb240f/documents/IUC5-e9de0b02-286e-4896-85a1-1562845c3c37_bdb70046-7ce4-499f-bfe1-6ecadc35dbee.html,,oral,LD50,"2,600 mg/kg bw",, Zinc bis[O-(6-methylheptyl)] bis[O-(sec-butyl)] bis(dithiophosphate),93819-94-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2011571c-6842-455a-81c6-c3f36ccb240f/documents/IUC5-e9de0b02-286e-4896-85a1-1562845c3c37_bdb70046-7ce4-499f-bfe1-6ecadc35dbee.html,,dermal,LD50,"3,160 mg/kg bw",, Zinc bis[O-(6-methylheptyl)] bis[O-(sec-butyl)] bis(dithiophosphate),93819-94-4,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2011571c-6842-455a-81c6-c3f36ccb240f/documents/IUC5-e9de0b02-286e-4896-85a1-1562845c3c37_bdb70046-7ce4-499f-bfe1-6ecadc35dbee.html,,inhalation,LC50,"2,000 mg/m3",, "Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate)",4259-15-8,"28 day study:The oral administration of the test material to rats by gavage, at a maximum dose level of 500 mg/kg/day for 28 days, resulted in adverse, treatment-related changes at 500 and 250 mg/kg/day. There were no treatment-related changes detected in the parameters measured among animals of either sex treated with 125 mg/kg/d. The NOAEL for systemic toxicity was therefore considered to be 125 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4918a9ee-1335-4baf-a80c-038197012ec1/documents/IUC5-e750c68a-e35d-4c13-963d-771328c0aed1_17259765-a539-4d93-8a94-e117eea49ff0.html,,,,,, "Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate)",4259-15-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/4918a9ee-1335-4baf-a80c-038197012ec1/documents/IUC5-e750c68a-e35d-4c13-963d-771328c0aed1_17259765-a539-4d93-8a94-e117eea49ff0.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat "Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate)",4259-15-8,The test material is not acute toxic. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4918a9ee-1335-4baf-a80c-038197012ec1/documents/IUC5-4a73abab-5951-4235-9219-3934ca7957c9_17259765-a539-4d93-8a94-e117eea49ff0.html,,,,,, "Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate)",4259-15-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4918a9ee-1335-4baf-a80c-038197012ec1/documents/IUC5-4a73abab-5951-4235-9219-3934ca7957c9_17259765-a539-4d93-8a94-e117eea49ff0.html,,oral,LD50,"3,100 mg/kg bw",, "Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate)",4259-15-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/4918a9ee-1335-4baf-a80c-038197012ec1/documents/IUC5-4a73abab-5951-4235-9219-3934ca7957c9_17259765-a539-4d93-8a94-e117eea49ff0.html,,dermal,LD50,"5,000 mg/kg bw",, Zinc bromide,7699-45-8,"Non-human informationThe repeated dose toxicity of water soluble zinc sulphate and zinc monoglycerolate has been examined in a total of 3 subchronic oral feeding studies. Due to the different dosing regimens, the lowest NOAEL was determined to be 31.5 mg/kg bw/day of zinc monoglycerolate which equals a total zinc exposure of approximate 13 mg/kg bw/day. The zinc NOAEL derived from the feeding studies with zinc sulphate was determined to be 104 mg Zn/kg bw/day in mice and approximately 53.5 mg/kg bw/day in rats. At higher doses the most important effects in the rats were the development of hypocupremia, and significant changes in the pancreas (i.e., focal acinar degeneration and necrosis) and a decreased number of pigmented macrophages in spleen.No longer term inhalation studies allowing to derive a robust NOEL for the inhalatory exposure of the respective zinc compounds has been identified. In a short term 3-day inhalation study with guinea pigs, a concentration of 2.3 mg ultrafine ZnO/m3 (3 hours/day) resulted in changes in neutrophils and activities of lactate dehydrogenase and alkaline phosphatase in the pulmonary fluid. At higher concentrations increased protein concentration, neutrophils, and enzyme activities in lung lavage fluids were seen, together with significant centriacinar inflammation of the pulmonary tissue. Inhalatory doses of 2.7 mg ultrafine ZnO/m3 for 5 days 3hours/day did not alter the lung function parameters in guinea pigs, but at 5 and 7 mg ultrafine ZnO/m3 exposure according to a similar pattern, a gradual decrease in total lung capacity, vital capacity and reduction of the carbon monoxide diffusing capacity was seen in combination with inflammatory changes and edema. The relevance of the findings in studies with ultra-fine zinc oxide fumes is unclear with respect to commercial grade zinc oxide, as the latter is of much larger particle size and can have different toxicological characteristics. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55ab8fe5-c4ef-4289-97f2-9dd23d743054/documents/IUC5-31a3d9e2-be8c-476d-9e40-e91a1ac0946c_ea56bc5f-e92d-49c0-958e-5b6ee9a107e0.html,,,,,, Zinc bromide,7699-45-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55ab8fe5-c4ef-4289-97f2-9dd23d743054/documents/IUC5-31a3d9e2-be8c-476d-9e40-e91a1ac0946c_ea56bc5f-e92d-49c0-958e-5b6ee9a107e0.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,2.7 mg/m3,,guinea pig Zinc bromide,7699-45-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/55ab8fe5-c4ef-4289-97f2-9dd23d743054/documents/IUC5-31a3d9e2-be8c-476d-9e40-e91a1ac0946c_ea56bc5f-e92d-49c0-958e-5b6ee9a107e0.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,13.3 mg/kg bw/day,,rat Zinc bromide,7699-45-8,"Soluble zinc chloride is harmful following acute oral exposure (LD50 range 1,100 to 1,260 mg/kg bw) and is classified as harmful if swallowed (Xn; R22) according EC criteria (Council Directive 67/548/EEC). Zinc chloride has also demonstrated acute toxicity via the inhalation route (LC50 ≤ 1,975 mg/m3). However, since the exposure of the animals to the size of the particles is not truly representative of exposure to humans under normal conditions, it is difficult to assess whether or not, zinc chloride is acutely toxic since a four hour LC50 value could not be derived and a clear dose-response relationhip coud not be established. Airway irritation has been observed both in animals and in humans, zinc chloride has the potential to be a respiratory tract irritant. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55ab8fe5-c4ef-4289-97f2-9dd23d743054/documents/IUC5-14fb2fce-7d22-4bbc-90af-386d5ef3399f_ea56bc5f-e92d-49c0-958e-5b6ee9a107e0.html,,,,,, Zinc bromide,7699-45-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55ab8fe5-c4ef-4289-97f2-9dd23d743054/documents/IUC5-14fb2fce-7d22-4bbc-90af-386d5ef3399f_ea56bc5f-e92d-49c0-958e-5b6ee9a107e0.html,,oral,LD50,"1,100 mg/kg bw",, Zinc bromide,7699-45-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55ab8fe5-c4ef-4289-97f2-9dd23d743054/documents/IUC5-14fb2fce-7d22-4bbc-90af-386d5ef3399f_ea56bc5f-e92d-49c0-958e-5b6ee9a107e0.html,,dermal,LD50,"2,000 mg/kg bw",, Zinc bromide,7699-45-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/55ab8fe5-c4ef-4289-97f2-9dd23d743054/documents/IUC5-14fb2fce-7d22-4bbc-90af-386d5ef3399f_ea56bc5f-e92d-49c0-958e-5b6ee9a107e0.html,,inhalation,discriminating conc.,2 mg/m3,, Zinc cyanide,557-21-1," For that endpoint, one reliable study to assess the repeated dose toxicity on hydrogen cyanide on rats was available. Based on the similarity of chemical structures of zinc cyanide and hydrogen cyanide, the study results on hydrogen cyanide can be extrapolated to zinc cyanide. Hydrogen cyanide has a NOAEL of 100 ppm, which can be converted into a NOAEL of 10.8 mg/kg/day for the cyanide. When extrapolated to zinc cyanide, the NOAEL of zinc cyanide becomes 24.3 mg/kg/day. These calculations are supported by the Integrated Risk Information System (IRIS). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e0c5243-0f26-43fa-87fe-37451cf25593/documents/d15a87ed-e915-4160-86db-38fffd381552_4b00e2d0-fb55-4e6f-acb3-a0b497b1da7b.html,,,,,, Zinc cyanide,557-21-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/0e0c5243-0f26-43fa-87fe-37451cf25593/documents/d15a87ed-e915-4160-86db-38fffd381552_4b00e2d0-fb55-4e6f-acb3-a0b497b1da7b.html,Chronic toxicity – systemic effects,oral,NOAEL,24.3 mg/kg bw/day,,rat Zinc cyanide,557-21-1," For that endpoint, two reliable studies to assess the acute toxicity oral and dermal on the registered substance on rats was available. These studies were performed according to the OECD 423 guideline (acute toxicité oral) and OECD 402 guideline (acute toxicity dermal). Under the experimental conditions, the registered substance "" Zinc cyanide batch n°10185145"" has an LD50 above 300mg/L for oral acute toxicity and an LD50 above 100mg/kg for dermal acute toxicity. Therfore, GHS classification of the test substance, Zinc cyanide was classified to be ‘Category 4 (> 300 mg/kg bw ~ 2,000 mg/kg bw) for oral acut toxicity and was classified to be ‘Category 2 (50 < LD50≤ 200 mg/kg bw) for dermal acute toxicity. The validity criteria were successful and the studies were therefore regarded as acceptable for that endpoint. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e0c5243-0f26-43fa-87fe-37451cf25593/documents/75153844-5b22-4391-8824-ef591a0e3886_4b00e2d0-fb55-4e6f-acb3-a0b497b1da7b.html,,,,,, Zinc cyanide,557-21-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e0c5243-0f26-43fa-87fe-37451cf25593/documents/75153844-5b22-4391-8824-ef591a0e3886_4b00e2d0-fb55-4e6f-acb3-a0b497b1da7b.html,,oral,LD50,300 mg/kg bw,adverse effect observed, Zinc cyanide,557-21-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0e0c5243-0f26-43fa-87fe-37451cf25593/documents/75153844-5b22-4391-8824-ef591a0e3886_4b00e2d0-fb55-4e6f-acb3-a0b497b1da7b.html,,dermal,LD50,100 mg/kg bw,adverse effect observed, Zinc di(benzimidazol-2-yl) disulphide,3030-80-6," According to the acute toxic class method an LD50 between 50 and 300 mg/kg bw was determined (TOXI-COOP, 2017). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b05f4b8c-1ebd-4bd7-80b2-4c08e1d3d406/documents/dde86dad-907d-4f8f-a0ab-7a20e59f1edc_f98181cb-5b2c-4648-98b7-076dadbb39a9.html,,,,,, Zinc dibenzoate,553-72-0,"Oral: The studies available on the analogue sodium benzoate are feeding studies in rat and mice (one drinking water study in mice). Mice seem to be less susceptible to the effects of the analogue than rats. Effects are severe decrease of body weight with effects in the liver. The no effect level is 2% in the diet of rats. In the reports available different conversion methods are used to calculate the actual test substance intake. This may have been done by actual measurement of food intake, but is not clearly described in the publications. Therefore a calculation was done based on the factors as described in the WHO report (EHS Environmental Health Criteria 240). This leads to a NOAEL of 1000 mg/kg bw based on the 2% dietary level in rats.In a chronic toxicity/carcinogenicity study in rats (Sodemoto, 1979) no signs of toxicity were reported at 2% of the analogue in feed (stated to be equivalent to 1000 mg/kg bw).Dermal: A study is available with a NOAEL of the key study of > 2500 mg/kg bw/day (Marroquin, 1981).Inhalation: A study is available with a NOAEL of the key study of 250 mg/m3 (Benson, 1981). These findings were primarily attributed to the physico-chemical properties of these fine low-solubility particles. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80d16b44-72ea-40dc-b162-da809dc37c81/documents/IUC5-3250816c-c29c-4e07-acb8-219bbae3f423_09381c53-3f82-4d5e-842c-71f031c95e50.html,,,,,, Zinc dibenzoate,553-72-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80d16b44-72ea-40dc-b162-da809dc37c81/documents/IUC5-3250816c-c29c-4e07-acb8-219bbae3f423_09381c53-3f82-4d5e-842c-71f031c95e50.html,Short-term repeated dose toxicity – systemic effects,dermal,NOAEL,"2,500 mg/kg bw/day",,rabbit Zinc dibenzoate,553-72-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80d16b44-72ea-40dc-b162-da809dc37c81/documents/IUC5-3250816c-c29c-4e07-acb8-219bbae3f423_09381c53-3f82-4d5e-842c-71f031c95e50.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,250 mg/m3,,rat Zinc dibenzoate,553-72-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/80d16b44-72ea-40dc-b162-da809dc37c81/documents/IUC5-3250816c-c29c-4e07-acb8-219bbae3f423_09381c53-3f82-4d5e-842c-71f031c95e50.html,Chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat Zinc dibenzoate,553-72-0,"The slightly soluble and insoluble zinc compounds (i.e., zinc oxide, zinc hydroxide, zinc phosphate, zinc carbonate, zinc metal and zinc sulphide) are of low acute, dermal and inhalation toxicity not requiring a classification for acute toxicity according to the EC criteria. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80d16b44-72ea-40dc-b162-da809dc37c81/documents/IUC5-a0174763-58b6-4180-a731-86cf2a866fa2_09381c53-3f82-4d5e-842c-71f031c95e50.html,,,,,, Zinc dibenzoate,553-72-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80d16b44-72ea-40dc-b162-da809dc37c81/documents/IUC5-a0174763-58b6-4180-a731-86cf2a866fa2_09381c53-3f82-4d5e-842c-71f031c95e50.html,,oral,LD50,"2,000 mg/kg bw",, Zinc dibenzoate,553-72-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80d16b44-72ea-40dc-b162-da809dc37c81/documents/IUC5-a0174763-58b6-4180-a731-86cf2a866fa2_09381c53-3f82-4d5e-842c-71f031c95e50.html,,dermal,LD50,"2,000 mg/kg bw",, Zinc dibenzoate,553-72-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/80d16b44-72ea-40dc-b162-da809dc37c81/documents/IUC5-a0174763-58b6-4180-a731-86cf2a866fa2_09381c53-3f82-4d5e-842c-71f031c95e50.html,,inhalation,LC50,5.41 mg/m3,, Zinc didocosanoate,16529-65-0," No acute toxicity studies with zinc didocosanoate are available, thus the acute toxicity will be addressed with existing data on the dissociation products zinc and docosanoic acid. Signs of acute oral toxicity are not expected for zinc ditetradecanoate, since for the moieties zinc and tetradecanoate have not shown signs of acute oral toxicity (LD50 > 2000mg/kg). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1792d3c1-0f3b-480a-9d3b-229a55216429/documents/7bb5e59c-48e5-4815-bf29-a571eb707dfc_7c9ed2e6-776a-4737-983b-28dfd1d5b2ec.html,,,,,, Zinc dioctanoate,557-09-5," No acute toxicity studies with zinc dioctanoate are available, thus the acute toxicity will be addressed with existing data on the dissociation products zinc and octanoic acid. Signs of acute oral toxicity are not expected for zinc dioctanoate, since for the moieties zinc and octanoate have not shown signs of acute oral toxicity (LD50 > 2000mg/kg). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7ef791d0-a759-41e9-9e98-5b6523132ac0/documents/b2ae205f-9f63-4335-88af-e0ad2d7f6326_97a7d6dc-f5d5-4407-ae5e-661131654f3b.html,,,,,, Zinc dipropionate,557-28-8," No repeated dose toxicity study with zinc dipropionate is available, thus the repeated dose toxicity will be addressed with existing data on its two individual moieties zinc and propionate. The hazard assessment is based on the most toxic moiety, i.e. the zinc cation. Please refer to the section for the respective assessment entity for data on the moieties. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7e4dff1c-60d2-4639-b712-638fbe8188f8/documents/12ecd78a-0d06-4b7c-8b6f-7ae4dcfdef06_387ec558-65ee-48fd-9d3f-0e2d0d5f73c5.html,,,,,, Zinc dipropionate,557-28-8," No acute toxicity study with zinc dipropionate is available, thus the acute toxicity will be addressed with existing data on its two individual moieties zinc and propionate, respectively propionic acid. Based on in vivo acute toxicity data on the moieties, it can safely be assumed, that zinc dipropionate has no pronounced acute toxicity. Please refer to the section for the respective assessment entity for data on the moieties. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7e4dff1c-60d2-4639-b712-638fbe8188f8/documents/4529d5a4-7f60-495c-ac21-8b712cb9f237_387ec558-65ee-48fd-9d3f-0e2d0d5f73c5.html,,,,,, Zinc dodecyl hydrogen disulphate,22397-58-6,For all analogues of alkyl sulfates (AS) a NOAEL of 488 mg/kg bw/day for oral and dermal exposure was established. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfd4e4e3-6694-46c2-b890-23b44703d453/documents/571bfc84-731f-4aaa-a8fe-6e203bf3b9e9_a21146e3-e7d5-451a-867b-eb6d84f47f17.html,,,,,, Zinc dodecyl hydrogen disulphate,22397-58-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfd4e4e3-6694-46c2-b890-23b44703d453/documents/571bfc84-731f-4aaa-a8fe-6e203bf3b9e9_a21146e3-e7d5-451a-867b-eb6d84f47f17.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,488 mg/kg bw/day,,rat Zinc dodecyl hydrogen disulphate,22397-58-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cfd4e4e3-6694-46c2-b890-23b44703d453/documents/571bfc84-731f-4aaa-a8fe-6e203bf3b9e9_a21146e3-e7d5-451a-867b-eb6d84f47f17.html,Sub-chronic toxicity – systemic effects,dermal,NOAEL,400 mg/kg bw/day,,mouse Zinc dodecyl hydrogen disulphate,22397-58-6,"Oral LD50 (OECD guideline 401), rat = 1800 mg/kg bwDermal LD50 (OECD guideline 402), rabbit > 2000 mg/kg bw (limit test) Acute toxicity by inhalation was not tested according to REGULATION (EC) No 1907/2006, Annex VIII, Section 8.5, Column 2. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfd4e4e3-6694-46c2-b890-23b44703d453/documents/c1a50c31-7990-4af8-ae28-b6a9416bc9ac_a21146e3-e7d5-451a-867b-eb6d84f47f17.html,,,,,, Zinc dodecyl hydrogen disulphate,22397-58-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cfd4e4e3-6694-46c2-b890-23b44703d453/documents/c1a50c31-7990-4af8-ae28-b6a9416bc9ac_a21146e3-e7d5-451a-867b-eb6d84f47f17.html,,oral,LD50,"1,800 mg/kg bw",adverse effect observed, Zinc ferrite brown spinel,68187-51-9,"A subacute inhalation toxicity study for Fe3O4, Fe2O3 and FeOOH and a subchronic inhalation study for Fe3O4 as representative source substances for the iron oxide category members are available. Additionally, a short-term (5-day) inhalation study with two different grades of nanomaterials was conducted. Rats were exposed to 10 and 30 mg/m³ of smaller nano-sized Fe2O3 and 30 mg/m³ of larger nano-sized Fe2O3. Sub-chronic repeated dose toxicity studies with Fe3O4, Fe2O3 and FeOOH as representative source substances for the iron oxide category members are available. A NOAEL of greater than 1000 mg/kg bw/day is derived for all three substances, based on a complete absence of adverse effects. For repeated dose toxicity via the dermal route, no reliable studies are available for the iron oxide category. Details on the category justification are given in the read-across document attached in IUCLID section 13.2. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6283c2c2-6eea-41cd-8f83-439b8f8ede9b/documents/IUC5-6f0e7db5-f09d-4afb-a91e-833b5b78d762_6604c6ec-dc4e-4fc0-bfb5-8f842559eff3.html,,,,,, Zinc ferrite brown spinel,68187-51-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6283c2c2-6eea-41cd-8f83-439b8f8ede9b/documents/IUC5-6f0e7db5-f09d-4afb-a91e-833b5b78d762_6604c6ec-dc4e-4fc0-bfb5-8f842559eff3.html,Repeated dose toxicity – local effects,inhalation,NOAEC,4.7 mg/m3,adverse effect observed,rat Zinc ferrite brown spinel,68187-51-9,"In 3 valid oral acute toxicity studies rats were treated with 2000, 5000, or 10000 mg/kg bw zinc ferrite brown spinel. During an observation time of 14 days none of the animals died. In an acute inhalation toxicity study with Fe2O3 as a surrogate for the iron oxide group the discriminating dose was 5050 mg/m³. No study for acute dermal toxicity is available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6283c2c2-6eea-41cd-8f83-439b8f8ede9b/documents/IUC5-11286adf-315c-4119-8f0a-04af878030db_6604c6ec-dc4e-4fc0-bfb5-8f842559eff3.html,,,,,, Zinc ferrite brown spinel,68187-51-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6283c2c2-6eea-41cd-8f83-439b8f8ede9b/documents/IUC5-11286adf-315c-4119-8f0a-04af878030db_6604c6ec-dc4e-4fc0-bfb5-8f842559eff3.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Zinc ferrite brown spinel,68187-51-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6283c2c2-6eea-41cd-8f83-439b8f8ede9b/documents/IUC5-11286adf-315c-4119-8f0a-04af878030db_6604c6ec-dc4e-4fc0-bfb5-8f842559eff3.html,,inhalation,discriminating conc.,"5,050 mg/m3",no adverse effect observed, Zinc fluoride,7783-49-5," Repeated dose toxicity data are not available for zinc difluoride. However, studies conducted with soluble zinc and fluoride substances were included in the dossier. For information please refer to the endpoint discussion for zinc and fluoride. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/f8294755-4ee4-4bab-b216-84d10d9745a0/documents/7c90ac5e-b2e5-4615-a707-bfd5d71a89c5_0528b680-6717-46a0-88bf-3e6fffcceef6.html,,,,,, Zinc fluoride,7783-49-5," Reliable substance-specific information concerning the toxicity for zinc difluoride does not exist. Instead, toxicological information on soluble inorganic fluoride (e.g., sodium and potassium) substances and soluble inorganic zinc substances (i.e., zinc dichloride) were extrapolated to zinc(II) fluoride considering that the toxicological effects mainly based on the concentrations of the Zn2+ and F- ions. Based on the results of the acute toxicity tests it can safely be assumed that the fluoride is the driver for acute toxicity. Hence, LC/LD50 values were re-calculated to zinc difluoride and C&L were given based on these values. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8294755-4ee4-4bab-b216-84d10d9745a0/documents/6fe4d121-465e-40b8-88a3-3b45794eee22_0528b680-6717-46a0-88bf-3e6fffcceef6.html,,,,,, Zinc fluoride,7783-49-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8294755-4ee4-4bab-b216-84d10d9745a0/documents/6fe4d121-465e-40b8-88a3-3b45794eee22_0528b680-6717-46a0-88bf-3e6fffcceef6.html,,oral,LD50,137 mg/kg bw,adverse effect observed, Zinc fluoride,7783-49-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8294755-4ee4-4bab-b216-84d10d9745a0/documents/6fe4d121-465e-40b8-88a3-3b45794eee22_0528b680-6717-46a0-88bf-3e6fffcceef6.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, Zinc fluoride,7783-49-5,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f8294755-4ee4-4bab-b216-84d10d9745a0/documents/6fe4d121-465e-40b8-88a3-3b45794eee22_0528b680-6717-46a0-88bf-3e6fffcceef6.html,,inhalation,LC50,"2,462 mg/m3",adverse effect observed, zinc glycyniate,7214-08-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f2d63c90-7cf1-4956-a5e9-d50e4b72bb48/documents/9a331756-fbd6-4be0-971b-d6708eac4287_b103f2cc-5668-4252-879c-2ffda286ea6c.html,Repeated dose toxicity – local effects,inhalation,NOAEC,2.5 mg/m3,no adverse effect observed, zinc glycyniate,7214-08-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2d63c90-7cf1-4956-a5e9-d50e4b72bb48/documents/038aca39-b462-455b-a8ef-a1d8dae751d0_b103f2cc-5668-4252-879c-2ffda286ea6c.html,,oral,LD50,"1,500 mg/kg bw",adverse effect observed, zinc glycyniate,7214-08-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2d63c90-7cf1-4956-a5e9-d50e4b72bb48/documents/038aca39-b462-455b-a8ef-a1d8dae751d0_b103f2cc-5668-4252-879c-2ffda286ea6c.html,,dermal,LD50,"2,000 mg/kg bw",adverse effect observed, zinc glycyniate,7214-08-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f2d63c90-7cf1-4956-a5e9-d50e4b72bb48/documents/038aca39-b462-455b-a8ef-a1d8dae751d0_b103f2cc-5668-4252-879c-2ffda286ea6c.html,,inhalation,LC50,4.45 ,adverse effect observed, Zinc hexafluorosilicate,16871-71-9," Data on repeated dose toxicity does not need to be provided due to exposure consideration. However, the substance decomposes under physiological conditions and releases fluorid which is assessed here in order not to oversee any relevant toxicological effects. Oral uptake amount leads to symptoms of fluoride poisoning if taken in considerable quantity (Marx 2006; Greyer 1975). Zinc metal was assessed by the Netherlands, findings published in EU Risk Assessment Report - Zinc metal. Zinc is an essential element and is regulated in the body (Cleven 1992), thus, no toxicity is expected by repeated intake of small dosis. Hydrogen fluoride has been assessed by the Netherlands and the findings were published in the EU Risk Assessment Report - Hydrogen Fluoride. Although various data on animal studies, human studies and epidemiological data were assessed, the most reliable data were consider to be two inhalatory studies on rats. These were used to derive an NOAEL of 0.72 mg HF/m3. The NOAEL of 0.72 mg/m3 derived in inhalatory studies with hydrogen fluoride in rats in not used to derive a DNEL. HF is absorbed very quickly by the body irrespective of exposure route. If fluoride is taken orally it is absorbed from the gastrointestinal tract quickly depending on amount of acid in the stomach. Uptake is slowed down by food, especially if calcium rich due to formation of inert calcium fluoride. Zinc hexafluorosilicate will decompose if getting in contact with water, e.g. moisture and does not directly form HF but rather a mixture of zinc cation, hydrated silica and fluoride. HF formation depends on the pH of water or solution the zinc hexafluorosilicate reacts with. Therefore, HF will not always form when zinc hexafluorosilicate decomposes but the worst-case approach is taken. The stated threshold of 1.5 mg/m3 is the SCOEL for hydrogen fluoride, 8 -hour TWA. Report ""Recommendation from Scientific Committee on Occupational Exposure Limits for Fluorine, Hydrogen Fluoride and Inorganic Fluorides (not uranium hexafluoride)"" is attached to this dossier and can be downloaded at https://www.ser.nl/documents/72888.pdf The value is not corrected for stoichiometry as it would raise the threshold to 2.7 mg/m3. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c742a80b-b112-49a8-a92c-6a4f99c85034/documents/470ddd12-602b-4c11-81ba-efa7003f9ce4_ba3fa450-eb01-45ef-a5d2-1a98c2693ce5.html,,,,,, Zinc hexafluorosilicate,16871-71-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/c742a80b-b112-49a8-a92c-6a4f99c85034/documents/470ddd12-602b-4c11-81ba-efa7003f9ce4_ba3fa450-eb01-45ef-a5d2-1a98c2693ce5.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,0.72 mg/m3,,rat Zinc hexafluorosilicate,16871-71-9, No animal studies have been performed on zinc hexafluorosilicate due to the corrosivity of the substance. Human data on intoxication with zinc hexafluorosilicate is presented and displays typical symptoms of fluoride intoxication. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/c742a80b-b112-49a8-a92c-6a4f99c85034/documents/997a3e30-e9d2-4e67-8747-5c33e3ae7f71_ba3fa450-eb01-45ef-a5d2-1a98c2693ce5.html,,,,,, Zinc iron chromite brown spinel,68186-88-9,"In conclusion, since the dissolved Zn, Fe, Cr and Ni concentrations from this pigment (zinc iron chromite brown spinel) under simulated physiological conditions were below 5.8 µg/L, 6.03 µg/L, 62 µg/L and 43 µg/L respectively, even at the highest loading of 0.1g/L, referring to a solubility of 0.006%, 0,006%, 0,06 and 0,04 %, the pigment is considered biologically inert. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/bc5845ad-b383-4e69-9f42-e4327992e1a9/documents/IUC5-b47558e0-d6ef-48cb-88c0-54bb2f0a52d2_3eaf8647-f603-4766-9211-ae0181c93369.html,,,,,, Zinc iron chromite brown spinel,68186-88-9,Acute oral toxicity: LD50 > 2000 mg/kg bw (OECD 423 (1996); Non-GLP compliant)Acute inhalation toxicity: LC50 (rats; 4 hours) > 5.06 mg/L air (actual concentration) (OECD 436 (2009); GLP compliant) ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/bc5845ad-b383-4e69-9f42-e4327992e1a9/documents/IUC5-dce64420-b33f-4e2a-b620-13af3e7b76e4_3eaf8647-f603-4766-9211-ae0181c93369.html,,,,,, Zinc isodecyl phosphorodithioate,25103-54-2,The results from a repeat dose toxicity (oral) study are read across from an analogous substance. The NOAEL was 125 mg/kg/day for systemic toxicity. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1f959c28-8cd1-4be4-9127-9552c2fbc546/documents/897a55e9-003b-491b-8cc4-6e5d4f9cc962_96ec44a4-1fa6-451e-bba1-efa99725945c.html,,,,,, Zinc isodecyl phosphorodithioate,25103-54-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/1f959c28-8cd1-4be4-9127-9552c2fbc546/documents/897a55e9-003b-491b-8cc4-6e5d4f9cc962_96ec44a4-1fa6-451e-bba1-efa99725945c.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Zinc isodecyl phosphorodithioate,25103-54-2,"Based on test results for analogous substances,Zinc, bis(O,O-diisodecyl phosphorodithioato.kappa.s,.kappa.s’) is not considered to be acutely toxic. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f959c28-8cd1-4be4-9127-9552c2fbc546/documents/a96ef87f-3770-4474-9e0d-851c3617a035_96ec44a4-1fa6-451e-bba1-efa99725945c.html,,,,,, Zinc isodecyl phosphorodithioate,25103-54-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f959c28-8cd1-4be4-9127-9552c2fbc546/documents/a96ef87f-3770-4474-9e0d-851c3617a035_96ec44a4-1fa6-451e-bba1-efa99725945c.html,,oral,LD50,"3,100 mg/kg bw",, Zinc isodecyl phosphorodithioate,25103-54-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1f959c28-8cd1-4be4-9127-9552c2fbc546/documents/a96ef87f-3770-4474-9e0d-851c3617a035_96ec44a4-1fa6-451e-bba1-efa99725945c.html,,dermal,LD50,"5,000 mg/kg bw",, Zinc methacrylate,13189-00-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8bed4e1b-26a1-43aa-b2d0-e655cee2c0dc/documents/IUC5-5381eec6-162c-47f9-a249-38aaa1985a8c_2888c385-3ddd-44e7-8ea9-60744eb7c95e.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,53.5 mg/kg bw/day,,rat Zinc methacrylate,13189-00-9,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): GLP and OECD guideline-compliant study with Klimisch score 1 Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): GLP and OECD guideline-compliant study with Klimisch score 1 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bed4e1b-26a1-43aa-b2d0-e655cee2c0dc/documents/IUC5-ebd05361-b151-46d7-846a-a91c239693b7_2888c385-3ddd-44e7-8ea9-60744eb7c95e.html,,,,,, Zinc methacrylate,13189-00-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bed4e1b-26a1-43aa-b2d0-e655cee2c0dc/documents/IUC5-ebd05361-b151-46d7-846a-a91c239693b7_2888c385-3ddd-44e7-8ea9-60744eb7c95e.html,,oral,LD50,ca.500 mg/kg bw,adverse effect observed, Zinc methacrylate,13189-00-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8bed4e1b-26a1-43aa-b2d0-e655cee2c0dc/documents/IUC5-ebd05361-b151-46d7-846a-a91c239693b7_2888c385-3ddd-44e7-8ea9-60744eb7c95e.html,,inhalation,LC50,"ca.5,320 mg/m3",no adverse effect observed, Zinc m-toluate,68092-46-6," No repeated dose toxicity study with zinc m-toluate is available, thus the repeated dose toxicity will be addressed with existing data on the individual moieties zinc and m-toluate. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/cc700f6e-478d-4c2d-855c-7ac1e5b230a0/documents/f13ac515-0b13-4452-b8ad-bda7f1b0214d_5ade2b01-be61-4b07-8894-3c4aff374fc2.html,,,,,, Zinc m-toluate,68092-46-6," No acute toxicity study with zinc m-toluate is available, thus the acute toxicity will be addressed with existing data on the individual moieties barium and m-toluate. Signs of acute oral or acute dermal toxicity are not expected for zinc m-toluate, since for the moiety zinc, acute dermal toxicity is considered to be low in view of the poor absorption by this route and the moiety m-toluate has not shown signs of acute oral or acute dermal toxicity in experimental testing (LD50 > 2000mg/kg). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/cc700f6e-478d-4c2d-855c-7ac1e5b230a0/documents/d1d515a1-50b8-4568-b04b-56eaaaa3e7cd_5ade2b01-be61-4b07-8894-3c4aff374fc2.html,,,,,, "Zinc O,O,O',O'-tetrabutyl bis(phosphorodithioate)",6990-43-8,"Based on read-across from a structurally similar substance:Subacute: NOAEL portal-of-entry (rat, m/f) 40 mg/kg bw/daySubacute: NOAEL systemic toxicity (rat, m/f) 160 mg/kg bw/day (highest dose level) ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/aa21cf4f-f82a-42ee-8a74-b80309cd8a34/documents/IUC5-8a1f8b28-54c9-4741-a87c-d67c9c14450c_056dc680-118d-4bd0-af5b-c42786051848.html,,,,,, "Zinc O,O,O',O'-tetrabutyl bis(phosphorodithioate)",6990-43-8,"Based on substance specific data and/or read-across from a structurally similar substance:Oral: LD50 (rat, m/f) > 2000 mg/kg bwInhalation: LC50 (rat, m/f) > 2.3 mg/L air (based on read-across)Dermal: LD50 (rat/rabbit, m/f) > 2000 mg/kg bw (based on weight of evidence and read-across) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/aa21cf4f-f82a-42ee-8a74-b80309cd8a34/documents/IUC5-bb60905e-06c8-4764-8f35-0589f231f887_056dc680-118d-4bd0-af5b-c42786051848.html,,,,,, "Zinc O,O,O',O'-tetrakis(1,3-dimethylbutyl) bis(phosphorodithioate)",2215-35-2,"Repeat dose oral toxicity data is not available for EC 218-679-8-9, but an OECD 422 study is available for an analogous substance EC 270-608-0 and suitable for read across. In this study, the parental NOAEL for systemic toxicity also was determined to be 160 mg/kg/day. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b54677fe-5187-4f0b-aea8-fc2cbc617d5e/documents/IUC5-30e073e9-c514-40c5-929c-7198483d05af_0ee90ec4-86b3-42af-a1b3-330d11aeee37.html,,,,,, "Zinc O,O,O',O'-tetrakis(1,3-dimethylbutyl) bis(phosphorodithioate)",2215-35-2,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b54677fe-5187-4f0b-aea8-fc2cbc617d5e/documents/IUC5-30e073e9-c514-40c5-929c-7198483d05af_0ee90ec4-86b3-42af-a1b3-330d11aeee37.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,160 mg/kg bw/day,,rat "Zinc O,O,O',O'-tetrakis(1,3-dimethylbutyl) bis(phosphorodithioate)",2215-35-2,The test material is not acutely toxic. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b54677fe-5187-4f0b-aea8-fc2cbc617d5e/documents/IUC5-b4a5b48b-783c-48db-a1f2-2d5d2a53ed1b_0ee90ec4-86b3-42af-a1b3-330d11aeee37.html,,,,,, "Zinc O,O,O',O'-tetrakis(1,3-dimethylbutyl) bis(phosphorodithioate)",2215-35-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b54677fe-5187-4f0b-aea8-fc2cbc617d5e/documents/IUC5-b4a5b48b-783c-48db-a1f2-2d5d2a53ed1b_0ee90ec4-86b3-42af-a1b3-330d11aeee37.html,,oral,LD50,"2,230 mg/kg bw",, "Zinc O,O,O',O'-tetrakis(1,3-dimethylbutyl) bis(phosphorodithioate)",2215-35-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b54677fe-5187-4f0b-aea8-fc2cbc617d5e/documents/IUC5-b4a5b48b-783c-48db-a1f2-2d5d2a53ed1b_0ee90ec4-86b3-42af-a1b3-330d11aeee37.html,,dermal,LD50,"25,000 mg/kg bw",, "Zinc O,O,O',O'-tetrakis(1,3-dimethylbutyl) bis(phosphorodithioate)",2215-35-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b54677fe-5187-4f0b-aea8-fc2cbc617d5e/documents/IUC5-b4a5b48b-783c-48db-a1f2-2d5d2a53ed1b_0ee90ec4-86b3-42af-a1b3-330d11aeee37.html,,inhalation,LC50,0.002 mg/m3,, Zinc selenite,13597-46-1,"Based on a comparison between toxicity reference values of zinc compounds and selenium compounds, it can safely be assumed that the selenium/selenite moiety of zinc selenite is generally of higher toxicological relevance than the zinc cations. Comparing the DNELs for the zinc ion itself with the zinc levels that are associated with the DNELs for zinc selenite (based on selenite-data) indicated significantly higher values (in the range of factor 10 to 20) for the DNELs derived for the zinc ion itself. Therefore, the subsequent assessment of the toxicity of zinc selenite focuses on the selenium moiety.   Several reliable short-term repeated dose and sub-chronic studies are availble for the oral route:       Abdo (1994), NOAEL rat: 0.4 mg Se/kg bw/d (sub-chronic test with sodium selenite), NOAEL 0.4 mg Se/kg bw/d (sub-chronic test with sodium selenate)     Abdo (1994), NOAEL mouse: 0.9 mg Se/kg bw/d (sub-chronic test with sodium selenite), NOAEL 0.8 mg Se/kg bw/d (sub-chronic test with sodium selenate)     Bioulac (1992), NOAEL rat: 0.12 mg Se/kg bw/d (test with sodium selenite)     Johnson (2000), NOAEL mouse: 0.36 mg Se/kg bw/d (test with sodium selenite) Based on these data, a NOAEL for rats of 0.4 mg Se/ kg bw/day has been selected as the key value for repeated dose toxicity via the oral route for the different Se-compounds within the current category. No studies on repeated dose toxicity via inhalation or dermal route are available. Yang et al. (1989): NOAEL man: Se-intake of 850 µg Se/day per person; this figure is used as starting point for DNEL derivation.   It has to be emphasized, that the NOAEL according to Yang et al. (1989), which is used as starting point for DNEL derivation is based on human data. The existing studies on humans are considering a wealth of toxicological endpoints and overrule the available animal-based data by far. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7a89608d-5a7b-49b7-b125-69ac23c0f1be/documents/IUC5-ac07bb6c-ef44-4e71-9ab9-58c9cafd4bcb_b7ac1f82-7392-418f-a0a9-b8ba0ed295f0.html,,,,,, Zinc selenite,13597-46-1,"Zinc selenite: Acute oral toxicity: LD50 of 50-500 mg/kg dw (Prinsen, 1996c) Acute inhalation toxicity: LD50 of 1-5 mg/L air (Leuschner, 2010) Dermal toxicity: waived  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Literature data of good quality (Klimisch 2); effects between 200 and 500 mg/kg bw for males and between 50 and 200 mg/kg bw for females. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): Read-across from GLP study of hight quality (Klimisch 1) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a89608d-5a7b-49b7-b125-69ac23c0f1be/documents/e6d81eba-b453-41de-930a-0a8620cef3ae_b7ac1f82-7392-418f-a0a9-b8ba0ed295f0.html,,,,,, Zinc selenite,13597-46-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a89608d-5a7b-49b7-b125-69ac23c0f1be/documents/e6d81eba-b453-41de-930a-0a8620cef3ae_b7ac1f82-7392-418f-a0a9-b8ba0ed295f0.html,,oral,LD50,> 50 mg/kg bw,adverse effect observed, Zinc selenite,13597-46-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7a89608d-5a7b-49b7-b125-69ac23c0f1be/documents/e6d81eba-b453-41de-930a-0a8620cef3ae_b7ac1f82-7392-418f-a0a9-b8ba0ed295f0.html,,inhalation,LC50,> 1 mg/L,adverse effect observed, "Zinc sulfide (ZnS), copper chloride-doped",68611-70-1,"Oral: The repeated dose toxicity of zinc sulfide has been examined in a sub-chronic oral repeated dose toxictiy study in Wistar rats. There were no treatment related deaths, no relevant treatment related clinical findings and no changes to food intake and body weight development. The NOAEL for systemic effects of zinc sulfide is above the limits dose of 1000 mg/kg bw/day. Inhalation: The substance zinc sulfide is an inorganic zinc substance with very poor water solubility and in vitro bioaccessibility in various biological media. In addition, the substance shows a pronounced tendency to form aggregates once becoming airborne, which leads to a low tendency for deposition in the deeper lung. Further toxicological data shows a complete lack of local effects towards (mucous) membranes, hence a very low hazard potential of the inhalable particles is assumed. Consequently, inhalation is not considered a relevant route of human exposure for zinc sulfide. Further experimental testing to quantify the inhalation potential is currently ongoing and will be reported once available. Information on repeated dose inhalation toxicity of more soluble and reactive zinc category substances, such as zinc oxide and zinc sulfate, is provided as supporting data for information purposes only. Dermal: According to Annex VIII and IX, column 2, the repeated dose toxicity test (dermal route) does not need to be conducted, since the available physicochemical properties and toxicological properties suggest a low potential for dermal absorption. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/faa424ca-ecc1-46bf-a6e7-aa03902d513c/documents/de679741-0c14-41b5-a94c-0dce35e7c4a6_8e6d8dbf-5d82-4c7f-b935-7c342f31fe33.html,,,,,, "Zinc sulfide (ZnS), copper chloride-doped",68611-70-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/faa424ca-ecc1-46bf-a6e7-aa03902d513c/documents/de679741-0c14-41b5-a94c-0dce35e7c4a6_8e6d8dbf-5d82-4c7f-b935-7c342f31fe33.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "Zinc sulfide (ZnS), copper chloride-doped",68611-70-1,"In the study performed by RCC Ltd (2003), rats were treated with ZnS-Sachtolith HD-S by oral gavage administration at a dosage of 2000 mg/kg body weight. All animals survived until the end of the study period. No clinical signs were observed during the course of the study. The median lethal dose of ZnS-Sachtolith HD-S after single oral administration to rats of both sexes, observed over a period of 14 days is: LD50 (rat): greater than 2000 mg/kg body weight. In the acute nose-only inhalation study performed by Bruer et al (2023), the maximum achievable concentration of ZnS aerosols (0,85mg/L) was tested in 3 male and 3 female rats. There were no deaths and no treatment related adverse effects observed during the 4h exposure of during the 14day observation period. The LC0 is therefore 0,82mg/L and the LC50 value is considered higher than 820.44 mg/m3, which is the maximum technically achievable aerosol concentration Regarding acute dermal toxicity, no data are available on which to evaluate toxicity for slightly soluble or insoluble zinc compounds. However, acute dermal toxicity can be considered to be low in view of the poor absorption by this route.  ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/faa424ca-ecc1-46bf-a6e7-aa03902d513c/documents/a575c56a-a88b-41ea-9f53-6ff274d67983_8e6d8dbf-5d82-4c7f-b935-7c342f31fe33.html,,,,,, "Zinc sulfide (ZnS), copper chloride-doped",68611-70-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/faa424ca-ecc1-46bf-a6e7-aa03902d513c/documents/a575c56a-a88b-41ea-9f53-6ff274d67983_8e6d8dbf-5d82-4c7f-b935-7c342f31fe33.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "Zinc sulfide (ZnS), copper chloride-doped",68611-70-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/faa424ca-ecc1-46bf-a6e7-aa03902d513c/documents/a575c56a-a88b-41ea-9f53-6ff274d67983_8e6d8dbf-5d82-4c7f-b935-7c342f31fe33.html,,inhalation,LC50,> 0.82 mg/L,no adverse effect observed, Reaction products of zinc oxide and glycerol,87189-25-1," Repeated-dose oral toxicity was assessed in a valid GLP-compliant subchronic feeding toxicity study according to OECD guideline 408 (1995) using Sprague-Dawley rats (ESL FT930588, 1995). Animals of both sexes were fed with 0, 0.05, 0.2 and 1% of test substance in diet for 13 weeks, respectively. Due to severe toxicity animals of the high dose group were fed with 0.5 % test substance in diet beginning from day 58. All animals of this dose group had to be sacrificed due to humane reasons on day 64. The NOAEL was set at 0.05% of test substance in the diet (corresponding to 33.7 mg/kg bw/d) and the LOAEL was set at a dietary level of 0.2% (corresponding to 136.7 mg/kg bw/d). ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/493135ea-b7ab-40ae-92f6-ba1f7405dfc9/documents/IUC5-8af9fb37-4b23-4ac4-b782-22bcc7df2ac7_0ed372be-b2f1-49e6-bcaa-5cc8e7f35b2f.html,,,,,, Reaction products of zinc oxide and glycerol,87189-25-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/493135ea-b7ab-40ae-92f6-ba1f7405dfc9/documents/IUC5-8af9fb37-4b23-4ac4-b782-22bcc7df2ac7_0ed372be-b2f1-49e6-bcaa-5cc8e7f35b2f.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,33.7 mg/kg bw/day,,rat Reaction products of zinc oxide and glycerol,87189-25-1, Both the dermal and oral LD50 were found to be higher than the limit dose of 2000 mg/kg ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/493135ea-b7ab-40ae-92f6-ba1f7405dfc9/documents/IUC5-192c67cc-6e0a-4f0e-814e-55302d110f16_0ed372be-b2f1-49e6-bcaa-5cc8e7f35b2f.html,,,,,, Reaction products of zinc oxide and glycerol,87189-25-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/493135ea-b7ab-40ae-92f6-ba1f7405dfc9/documents/IUC5-192c67cc-6e0a-4f0e-814e-55302d110f16_0ed372be-b2f1-49e6-bcaa-5cc8e7f35b2f.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, Reaction products of zinc oxide and glycerol,87189-25-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/493135ea-b7ab-40ae-92f6-ba1f7405dfc9/documents/IUC5-192c67cc-6e0a-4f0e-814e-55302d110f16_0ed372be-b2f1-49e6-bcaa-5cc8e7f35b2f.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "Zinc, desilverizing skims",69029-60-3,Repeated dose toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f715d07d-4dee-4545-aa04-c362f21a99d7/documents/IUC5-d3f1a071-df46-4883-9684-4f4d8f0df10f_5a6a3a0e-2d46-4952-9fc1-60568de18312.html,,,,,, "Zinc, desilverizing skims",69029-60-3,The acute toxicity is driven by the characteristics of the individual UVCB constituents. Relevant information on the individual UVCB constituents is reported in Section 7 Summary. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f715d07d-4dee-4545-aa04-c362f21a99d7/documents/IUC5-dfe08439-ec1e-4987-ae42-5bf7d806cb38_5a6a3a0e-2d46-4952-9fc1-60568de18312.html,,,,,, "Zinc, O,O-mixed (iso-Bu), (iso-Pr), (pentyl) phosphorodithioate",101747-77-7,"oral repeated dose, short term: source substance Zinc bis(O,O-diisobutyl dithiophosphate) (CAS 68457 -79 -4): GLP, according to OECD Guideline 422, Klimisch 1, rat, oral (gavage), NOEL (portal-of-entry) = 40 mg/kg bw/day (localised injury to the nonglandular portion of the stomach), NOAEL (systemic effects) = 160 mg/kg bw source substance Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259 -15 -8): GLP, similar to OECD Guideline 407, Klimisch 1, rat, oral (gavage), NOEL (portal-of-entry) = 10 mg/kg bw/day, NOAEL = 125 mg/kg bw/day (systemic effects).   Based on the available data and based on the performed studies for CSA as key value the value at which no adverse effect was observed was choosen. This value is a bit higher than the NOEL. Unfortunately the provided data is different, because one study shows the NOEL and the other one shows the NOAEL, but nevertheless the results are in range, because the observed NOAEL of the one substance is higher than the NOEL of the other substance.   sub-chronic toxicity: oral This study was conducted to evaluate the potential toxicity of the substance in Wistar rats following daily administration through oral gavage for 90 consecutive days as per the OECD Guideline 408. The prepared dose formulations of the test item in the vehicle were administered orally, by gavage, at three graduated dose levels (G2 - low dose, G3 - mid-dose, and G4 - high dose) to male and female Wistar rats for 90 consecutive days. Rats in the concurrent vehicle control group (G1) received vehicle only. To assess reversibility, persistence, or delayed occurrence of toxic effects, an additional group (G6 – high dose recovery) were treated at the high dose level for 90 days and then observed further for a period of 28 days without any treatment. For comparison purposes, a vehicle control recovery group (G5) was also included and was given vehicle alone over the equivalent period (90 days) and observed further for 28 days. During the experimental period, all rats were observed for signs of toxicity, morbidity, and mortality. Body weight was recorded at weekly intervals. Body weight change and food consumption were calculated at weekly intervals. An ophthalmological examination was performed before treatment and sacrifices. Neurobehavioral observations were performed prior to treatment and at weekly intervals thereafter. Functional observational battery was performed during 12th week of the treatment period and last week of recovery period. Vaginal smear was examined on the day of necropsy in all surviving female rats. At the end of the treatment and recovery periods, clinical pathology evaluations were performed on all surviving rats. All surviving rats were sacrificed and subjected to gross pathological examination. The weight of selected organs was recorded for each rat. Microscopic examination of tissues and organs was performed in vehicle control (G1) and high dose (G4) groups.   Dose Formulation Analysis: The a.i. concentration and homogeneity results of dose formulation samples collected on days 1, 29, 57, and 85 were within the acceptable range of ±15% of nominal concentration and %CV < 10, respectively. Mortality and Morbidity: No mortality or morbidity was observed throughout the treatment and recovery periods in male and female rats of control and low dose groups. Mortality was observed at different interval in rats treated with mid i.e., 150 mg/kg b. wt./day [Male – 2/10; female – 1/10] and high dose i.e., 300 mg/kg b. wt./day [Male – 7/15; female – 2/15] groups. Mortality observed in treatment groups was associated with clinical sign like, gasping, weakness and salivation. Incidence of mortalities was stopped on reduction on doses i.e., 25, 50 and 100 mg/kg b. wt./day from day 37 of male rats and day 36 of female rats. Hence, it was considered as an effect of test item treatment. Clinical Observations: All rats were normal throughout the dosing period in control and low dose groups. Mild to moderate salivation was observed intermittently during treatment days 6 to 90 in male and female rats of mid and high dose treated groups. It is well known that salivation is often observed in gavage studies and may be a reaction to the taste or irritation of the test item rather than an indication of toxicity (Wook-Joon Yu et al, 2011). Therefore, it was considered that the transient salivation observed in this study was of doubtful or no toxicological significance. Apart from salivation, there was weakness (on days 35 to 37) and gasping (days 62 to 68) also observed in male and female rats of mid and high dose groups. These signs were associated with mortalities. Hence, they were considered as effect of test item treatment and adverse in nature. Ophthalmological Examination: Ophthalmological examination of all rats did not reveal any abnormalities. Neurobehavioural Observations: No treatment-related changes were observed in neurobehavioural observations performed in male and female rats from the treatment groups when compared to those respective vehicle control groups. Functional Observational Battery: No treatment-related changes were observed in functional observational battery parameters performed in male and female rats from treatment groups compared to those respective vehicle control groups. Body Weight and Body Weight Change: No treatment related changes were observed in the mean body weight and mean body weight change of male and female rats of low and mid dose groups compared to that of vehicle control groups. In high dose groups, significant reduction in body weight and body weight change were observed at different interval in male rats. Body weight gain reduction in male rats of high dose groups was consistent and more than 10% of control groups. It was supported with reduction in food consumption also. Hence, reduction in body weight was considered as an effect of test item and adverse in nature. Food Consumption: No treatment related changes were observed in the mean food consumption of female rats of treatment groups compared to that of vehicle control group. A significant decrease in food consumption was observed at different interval in male and female rats of low, mid and high dose groups when compared with those respective vehicle control groups. Reduction in food consumption of male rats treated with low and mid dose groups was inconsistent and marginal. Hence, it was considered as an effect of test item but not adverse in nature. Reduction of food consumption at high dose was observed in both sexes and was consistent. In addition, this reduction was observed in more that 10% of control groups and associated with reduction in body weight. Therefore, these changes were considered as effect of test item and adverse in nature. Hematology and Coagulation: No treatment-related change was observed in hematology and coagulation parameters of rats from treatment groups compared to the respective vehicle control groups. Clinical Chemistry: No treatment-related change was observed in clinical chemistry parameters of rats from treatment groups compared to the respective vehicle control groups. Hormone Analysis: No treatment-related change was observed in serum level of T3, T4 and TSH of rats from treatment groups compared to those respective vehicle control groups. Organ Weight: No treatment-related change was observed in absolute and relative weight of organs in male and female rats of treatment groups compared to those respective vehicle control groups. Macroscopic Examination: Macroscopic examination did not reveal any treatment related lesion in treatment groups. Microscopic Examination: Microscopic examination did not reveal any treatment related lesion in treatment groups. Conclusion: Initial doses i.e., 150 and 300 mg/kg b. wt./day had produced mortality in male and female rats during dosing days 15 to 36. Additionally, mortality was also noticed after the reduction of doses i.e., 100 mg/kg b. wt./day level (during days 38 to 60). These mortalities were associated with toxic signs like weakness and gasping. Also, the high dose i.e., 300/100 mg/kg b. wt./day was associated with significant reduction in body weight as well as food consumption. All these changes were considered as adverse effects of test item treatment. Terminal parameters like clinical pathology, organ weight and microscopic examination did not reveal any treatment related adverse changes at any of the dose level. The No Observed Adverse Effect Level (NOAEL) of the test material was hence concluded as 50 mg/kg b. wt./day under the conditions and procedures followed in this study. Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): Good due to high quality guideline studies ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/247c0ad4-cbe1-4b8b-a0ed-ba99ec174ccc/documents/e680b8f6-e79c-497f-a446-d0c9ea3d8e97_cd3c2e92-e828-4c91-a634-9a95a0fc305d.html,,,,,, "Zinc, O,O-mixed (iso-Bu), (iso-Pr), (pentyl) phosphorodithioate",101747-77-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/247c0ad4-cbe1-4b8b-a0ed-ba99ec174ccc/documents/e680b8f6-e79c-497f-a446-d0c9ea3d8e97_cd3c2e92-e828-4c91-a634-9a95a0fc305d.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,50 mg/kg bw/day,,rat "Zinc, O,O-mixed (iso-Bu), (iso-Pr), (pentyl) phosphorodithioate",101747-77-7," oral route: source substance Zinc bis(O,O-diisobutyl dithiophosphate) (CAS 68457 -79 -4): non GLP, similar to OECD Guideline 401, Klimisch 1, rat, oral (gavage), LD50 = 3600 mg/kg bw source substance Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259 -15 -8): non GLP, similar to OECD Guideline 401, Klimisch 2, rat, oral (gavage), LD50 = 3100 mg/kg bw source substance Phosphorodithioic acid, mixed O,O-bis(1,3 -dimethylbutyl and iso-Pr) esters, zinc salts (CAS 84605 -29 -8): non GLP, similar to OECD 401, Klimisch 1, rat, oral (gavage), LD50 = 3100 mg/kg bw inhalative route: source substance Phosphorodithioic acid, mixed O,O-bis(1,3 -dimethylbutyl and iso-Pr) esters, zinc salts (CAS 84605 -29 -8): non GLP, similar to OECD 403, Klimisch 2, rat, inhalation (vapour) - whole body, 4 h, LD50 > 2.3 mg/L air (nominal) dermal route: source substance Zinc bis(O,O-diisobutyl dithiophosphate) (CAS 68457 -79 -4): GLP, similar to OECD 402 - according to 16CFR1500.3, Klimisch 2, rabbit, dermal - occlusive, 25 h, LD50 > 20000 mg/kg bw source substance Phosphorodithioic acid, mixed O,O-bis(1,3 -dimethylbutyl and iso-Pr) esters, zinc salts (CAS 84605 -29 -8): GLP, similar to OECD 402, Klimisch 2, rat, dermal - semiocclusive, 25 h, LD50 > 2002 mg/kg bw source substance Zinc bis[O,O-bis(2-ethylhexyl)] bis(dithiophosphate) (CAS 4259 -15 -8): non GLP, similar to OECD 402, Klimisch 2, rabbit, dermal - occlusive, 24 h, LD50 > 5000 mg/kg bw Based on the available data and based on the performed studies for CSA as key value the lowest value of all category members was choosen. Differences in the values of each category-member are obvious, but this is in range with the category approach, where nevertheless the members of one category may have different values, because all results show, that no substance has to be classified according to CLP (Regulation (EC) No 1272/2008). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/247c0ad4-cbe1-4b8b-a0ed-ba99ec174ccc/documents/e44c3f34-9ef2-4ce7-9169-efa207984a1a_cd3c2e92-e828-4c91-a634-9a95a0fc305d.html,,,,,, "Zinc, O,O-mixed (iso-Bu), (iso-Pr), (pentyl) phosphorodithioate",101747-77-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/247c0ad4-cbe1-4b8b-a0ed-ba99ec174ccc/documents/e44c3f34-9ef2-4ce7-9169-efa207984a1a_cd3c2e92-e828-4c91-a634-9a95a0fc305d.html,,oral,LD50,"3,100 mg/kg bw",no adverse effect observed, "Zinc, O,O-mixed (iso-Bu), (iso-Pr), (pentyl) phosphorodithioate",101747-77-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/247c0ad4-cbe1-4b8b-a0ed-ba99ec174ccc/documents/e44c3f34-9ef2-4ce7-9169-efa207984a1a_cd3c2e92-e828-4c91-a634-9a95a0fc305d.html,,dermal,LD50,"2,002 mg/kg bw",no adverse effect observed, "Zinc, O,O-mixed (iso-Bu), (iso-Pr), (pentyl) phosphorodithioate",101747-77-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/247c0ad4-cbe1-4b8b-a0ed-ba99ec174ccc/documents/e44c3f34-9ef2-4ce7-9169-efa207984a1a_cd3c2e92-e828-4c91-a634-9a95a0fc305d.html,,inhalation,LC50,"2,300 mg/m3",no adverse effect observed, Zirconium acetate,7585-20-8,Repeated dose toxicity: oralRossiello (2013) performed a combined repeated dose toxicity study (scored K1) with reproduction/developmental toxicity screening test via oral route in rats according to OECD guideline 422. This study was performed in compliance with GLP guidelines. A NOAEL of >=1000 mg/kg bw/day was derived (expressed as zirconium acetate anhydrous). No adverse effects were reported in this study. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/90906ec5-dcec-4aff-b334-fdf398a0b856/documents/IUC5-f58b2eee-174c-4f5a-840b-6a0aa0822cee_b45be25d-8af1-452c-8477-1f1eb9cfad46.html,,,,,, Zirconium acetate,7585-20-8,"Acute toxicity: oralA K2 acute oral toxicity test was performed in male and female Sprague Dawley rats according to a guideline similar to OECD Guideline 401 (Cochran et al., 1950). The acute oral LD50 value in male/female Sprague-Dawley rats was 4100 mg/kg bw.Acute toxicity: inhalationNo study available for this endpoint. In addition, the substance is marketed/used in aqueous solution and thus inhalation exposure is unlikely.Acute toxicity: dermalA K1 acute dermal toxicity test was performed in male and female Sprague-Dawley rats following the OECD 402 Guideline (Longobardi, 2013a). The acute dermal LD50 value in male/female Sprague-Dawley rats is > 2000 mg/kg bw (limit test).Acute toxicity: other routesNo reliable studies were available for this endpoint. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90906ec5-dcec-4aff-b334-fdf398a0b856/documents/IUC5-1cf525cb-9049-49be-aaac-bdc22dbc1ceb_b45be25d-8af1-452c-8477-1f1eb9cfad46.html,,,,,, Zirconium acetate,7585-20-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/90906ec5-dcec-4aff-b334-fdf398a0b856/documents/IUC5-1cf525cb-9049-49be-aaac-bdc22dbc1ceb_b45be25d-8af1-452c-8477-1f1eb9cfad46.html,,oral,LD50,"4,100 mg/kg bw",adverse effect observed, Zirconium carbide,12070-14-3," No data is available for Zirconium carbide (target substance). Thus, to assess the acute oral toxicity potential of Zirconium carbide available data from Zirconium disilicide (source substance) was used in a read-across approach. In an acute oral toxicity study in rats conducted according to OECD test guideline 423, the source substance Zirconium disilicide (99.47% purity) showed no adverse effects at the limit dose of 2000 mg/kg bw. Hence, the LD50 value is considered to be greater than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/14529602-959e-45cf-ae69-812a1bc1fdb9/documents/ca8e77ea-91de-4204-9581-7cdec5f70f9d_35bf6cf4-2d50-434d-975b-15df6cea5bbc.html,,,,,, Zirconium di(acetate) oxide,5153-24-2,In rats the oral LD50 was 4100 mg/kg bw. ,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/98686732-5e0e-400b-a900-c2ee352eaf84/documents/IUC5-ae44c1df-2484-4dde-89cb-7dc5c34c6b9f_0ae65ded-9313-455a-ae87-c6adff1a430d.html,,,,,, Zirconium dihydride,7704-99-6,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Lab report (RTC, Italy - 15 February 2017) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c0c041d-df14-4106-bc33-292d0ab11ad8/documents/2dab20be-e1e0-4089-931a-c857e7e01d63_d6af0adf-dd21-4339-b103-557925cfba20.html,,,,,, Zirconium dihydride,7704-99-6,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8c0c041d-df14-4106-bc33-292d0ab11ad8/documents/2dab20be-e1e0-4089-931a-c857e7e01d63_d6af0adf-dd21-4339-b103-557925cfba20.html,,oral,discriminating dose,"5,000 mg/kg bw",no adverse effect observed, Zirconium dinitrate oxide,13826-66-9,Repeated dose toxicity: oralRossiello (2013) performed a combined repeated dose toxicity study (scored Klimisch 1) with reproduction/developmental toxicity screening test via oral route in rats according to OECD guideline 422. This study was performed in compliance with GLP guidelines. A NOAEL of >=1000 mg/kg bw/day was derived (expressed as zirconium acetate anhydrous). No adverse effects were reported in this study. Zirconium acetate is a water-soluble zirconium compound with similar behaviour as zirconium dinitrate oxide. Therefore the results of this study are considered relevant for zirconium dinitrate oxide too. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a4936ba1-fd2c-4b61-bd7d-8628eec53fa2/documents/13be8572-1b55-4586-af48-0fc8af334a45_802462a4-ea77-49d6-a72e-cd5acaac430c.html,,,,,, Zirconium dinitrate oxide,13826-66-9," Acute oral toxicity In an acute oral toxicity study in female CRL:(WI) SPF rats, following the acute toxic class method according to OECD guideline 423, the LD50 was observed to be between 300 and 2000 mg/kg bw in female CRL:(WI) rats (referring to anhydrous zirconium dinitrate oxide) (Matting, 2015a, scored Klimisch 1). According to the GHS and CLP criteria, zirconium dinitrate oxide can be classified as 'Category 4' for acute oral toxicity. Acute inhalation toxicity No reliable studies have been identified. Endpoint coverage is not required since the endpoints on acute oral toxicity as well as acute dermal toxicity are covered. Moreover, the inhalation route of exposure is less relevant as zirconium dinitrate oxide is manufactured and used as aqueous solutions. Acute dermal toxicity In an acute dermal toxicity study in CRL:(WI) SPF rats (5 males and 5 females), following the fixed dose procedure according to OECD guideline 402, the LD50 was observed to be above 2000 mg/kg bw (referring to hydrated zirconium oxynitrate) (Bioassay, 2018, scored Klimisch 1). No mortality was observed. As a result, the substance does not need to be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a4936ba1-fd2c-4b61-bd7d-8628eec53fa2/documents/1192531f-ced3-4239-aad7-c13eaac0121b_802462a4-ea77-49d6-a72e-cd5acaac430c.html,,,,,, Zirconium disilicide,12039-90-6," In an acute oral toxicity study in rats conducted according to OECD test guideline 423, the target substance Zirconium disilicide (99.47% purity) showed no adverse effects at the limit dose of 2000 mg/kg bw. Hence, the LD50 value is considered to be greater than 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/0a99a70d-cb36-4b17-a0e7-14bf51e478bf/documents/55d7a2b5-e58e-4121-af2a-736d72a3ef08_c6caafaa-cfaf-4ff5-814e-c00f36bccc57.html,,,,,, Zirconium oxide sulphate,62010-10-0,"Repeated dose toxicity - oral route:Two studies are used in a weight of evidence approach.In the first study, Rossiello (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test via oral route in rats with the read across substance zirconium acetate according to OECD guideline 422 (GLP). A NOAEL of >=1000 mg/kg bw/day was derived. No systemic dose-related adverse effects were reported in this study. This study was scored as Klimisch 2 study (reliable with restrictions) because it is included for read across purposes in this dossier.In the second study, no adverse effects were reported after oral administration of zirconium basic carbonate (hydrated form) to rats during 17 weeks. The NOAEL for the tested material was >= 15100 mg hydrated zirconium carbonate/kg bw/day (Harrisson et al., 1951).Repeated dose toxicity - dermal route:No data are available for repeated dose toxicity, dermal route of exposure.Repeated dose toxicity - inhalation route:No data are available for repeated dose toxicity, inhalation route of exposure. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7b8028d3-75d4-483a-bb9e-eacab7f02dde/documents/IUC5-e1968b8d-ecba-43f9-9661-eff8d0809082_0e352626-505d-488a-8244-16b3c0007345.html,,,,,, Zirconium oxide sulphate,62010-10-0,"Acute toxicity: oralAn acute oral toxicity test (Klimisch 2) was performed in male and female Sprague Dawley rats according to OECD Guideline 401 (Cuthbert and Jackson, 1992a).The Median Oral Lethal Dose (LD50) in rats was greater than 5000 mg/kg (test substance). Acute toxicity: inhalationNo study available for this endpoint.Acute toxicity: dermalAn acute dermal toxicity test (Klimisch 2 due to read across purposes) was performed in male and female Sprague-Dawley rats according to the OECD Guideline 402 with the read across substance zirconium acetate (Longobardi, 2013). The acute dermal LD50 value in male/female Sprague-Dawley rats was > 2000 mg/kg bw (limit test, based on anhydrous zirconium acetate). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7b8028d3-75d4-483a-bb9e-eacab7f02dde/documents/IUC5-67ed2232-18dc-4d47-b1da-c756b5d1373a_0e352626-505d-488a-8244-16b3c0007345.html,,,,,, Zirconium praseodymium yellow zircon,68187-15-5,"It is concluded that the pigment was well tolerated and that no signs of systemic toxicity whatsoever were observed in rats when administered at a dose of 1000 mg/kg bw/day for up to 28 days. Either no or only marginal increases in Pr plasma concentrations were observed, and only a minor fraction (<<0.001%) of the total administered dose of Pr was collected via urine, documenting the lack of bioavailability of this pigment. The no observed adverse effect level (NOAEL) in rats is 1000 mg/kg/day.   In this 90-day repeated dose toxicity by inhalation study, rats were exposed via nose-only inhalation towards aerosol concentrations of 0.6, 2.5 and 10 mg/m³ of zirconium praseodymium yellow zircon. An inflammatory response was observed especially in the mid- and high-dose group animals, which are a cause of the significantly impaired lung clearance ocurring at overload conditions. This is corroborated by significantly increase clearance half-times exceeding the physiological values for these dose groups. A test-item-specific toxicity was not observed. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/dd6a7590-2d4d-420d-bb7d-183c381da25e/documents/IUC5-16e8f977-3d11-44f3-8817-dc566d715563_8003e87b-4f76-45e7-8e12-7290c82e7c00.html,,,,,, Zirconium praseodymium yellow zircon,68187-15-5,"Acute oral lethal dose (LD 50): > 2200 mg/kg bw.Acute toxicity, inhalation: LC50 > 5.5 mg/l. (MMAD/GSD: 2.7 µm (GSD: 3.9)) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/dd6a7590-2d4d-420d-bb7d-183c381da25e/documents/IUC5-35e253d7-c2ee-4392-96ba-d1c463367013_8003e87b-4f76-45e7-8e12-7290c82e7c00.html,,,,,, Zirconium propionate,84057-80-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/1897808f-8ed4-4061-8799-a98e0b58265d/documents/IUC5-6ccd33c9-7f08-4a31-ace0-34a92598a473_7d6dc66d-f2b8-457c-a078-48ea5e99d008.html,,oral,LD50,"> 2,000 mg/kg bw",no adverse effect observed, Zirconium sulphate,14644-61-2,"Rossiello (2013) performed a combined repeated dose toxicity study with reproduction/developmental toxicity screening test via oral route in rats with the read across substance zirconium acetate (another 'water soluble' zirconium compound) according to OECD guideline 422 (GLP). A NOAEL of >=1000 mg/kg bw/day (expressed as zirconium acetate anhydrous) was derived. No adverse effects were reported in this study. This study was scored as K2 study (reliable with restrictions), because of read across purposes and was considered as the key study. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f9b6bdb2-6022-4bd3-bece-d90dbbb9e26b/documents/IUC5-4870c4ad-e3a9-4cec-b383-2545818d6908_0f4d986d-f156-4ba6-924b-aafebcaf4f41.html,,,,,, Zirconium sulphate,14644-61-2,"Acute toxicity: oralOne reliable study was available and defined an LD50 of 3500 mg/kg bw in rats for zirconium sulfate (Cochran et al., 1950).Acute toxicity: inhalationNo study needs to be conducted as the substance is classified as corrosive to the skin.Acute toxicity: dermalNo study needs to be conducted as the substance is classified as corrosive to the skin. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9b6bdb2-6022-4bd3-bece-d90dbbb9e26b/documents/IUC5-c29bfc12-1173-4884-a59d-11febdc6bcb7_0f4d986d-f156-4ba6-924b-aafebcaf4f41.html,,,,,, Zirconium sulphate,14644-61-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f9b6bdb2-6022-4bd3-bece-d90dbbb9e26b/documents/IUC5-c29bfc12-1173-4884-a59d-11febdc6bcb7_0f4d986d-f156-4ba6-924b-aafebcaf4f41.html,,oral,LD50,"3,500 mg/kg bw",no adverse effect observed, Zirconium tetrabutanolate,1071-76-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8521f1f4-8522-4c66-8494-d427603fa347/documents/555f58bf-894d-4b5b-9e3d-2e49c7bfa3e5_3a7d3b45-885f-43bb-9e1d-9e0a5dacefc8.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,125 mg/kg bw/day,,rat Zirconium tetrabutanolate,1071-76-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/8521f1f4-8522-4c66-8494-d427603fa347/documents/555f58bf-894d-4b5b-9e3d-2e49c7bfa3e5_3a7d3b45-885f-43bb-9e1d-9e0a5dacefc8.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,676 mg/m3,,rat Zirconium tetrabutanolate,1071-76-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8521f1f4-8522-4c66-8494-d427603fa347/documents/740bab47-72d8-4efd-8d17-d42c54407f3e_3a7d3b45-885f-43bb-9e1d-9e0a5dacefc8.html,,oral,LD50,"2,510 mg/kg bw",no adverse effect observed, Zirconium tetrabutanolate,1071-76-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8521f1f4-8522-4c66-8494-d427603fa347/documents/740bab47-72d8-4efd-8d17-d42c54407f3e_3a7d3b45-885f-43bb-9e1d-9e0a5dacefc8.html,,dermal,LD50,"4,200 mg/kg bw",no adverse effect observed, Zirconium tetrabutanolate,1071-76-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8521f1f4-8522-4c66-8494-d427603fa347/documents/740bab47-72d8-4efd-8d17-d42c54407f3e_3a7d3b45-885f-43bb-9e1d-9e0a5dacefc8.html,,inhalation,LC50,"6,531 mg/m3",no adverse effect observed, Zirconium tetrachloride,10026-11-6,No reliable studies were available however ZrCl4 may be inhaled and was classified as skin corrosive. Therefore ZrCl4 is considered as corrosive to the respiratory tract. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/8fb9cb3f-766b-4419-8afd-99733bc366ba/documents/IUC5-07bb0abf-9d53-45df-8205-1a57fdf46d08_f68398dd-526e-4536-8296-343e4bd7bcff.html,,,,,, Zirconium tetranitrate,13746-89-9,No NOAEL was identified in the available studies. ,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/19a15d24-0a2e-49f9-9a3b-62be98a957e2/documents/IUC5-23aa1116-c5ff-46fb-9c17-f66fd3dd8538_39393a8b-58ee-471e-9e53-7bc3d11d0ce2.html,,,,,, Zirconium tetranitrate,13746-89-9,"Oral LD50 = 4100 mg ZrO(CH3OO)2/kg bw, mortality was observed (Cochran, 1950)Inhalation concentration of Zr >2≤ 3 mg/L, no mortality was observed (Mogilevskaya, 1968) ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19a15d24-0a2e-49f9-9a3b-62be98a957e2/documents/IUC5-d950cb60-de67-454a-b0aa-94f4fe3ed303_39393a8b-58ee-471e-9e53-7bc3d11d0ce2.html,,,,,, Zirconium tetranitrate,13746-89-9,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/19a15d24-0a2e-49f9-9a3b-62be98a957e2/documents/IUC5-d950cb60-de67-454a-b0aa-94f4fe3ed303_39393a8b-58ee-471e-9e53-7bc3d11d0ce2.html,,oral,LD50,"4,100 mg/kg bw",no adverse effect observed, Zirconium tetrapropanolate,23519-77-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/999af58c-adb0-4591-a0c8-81cd41303782/documents/5397ae84-0851-4444-a09a-c63491e1d4e8_cf9fbece-2ed3-43ab-b4c6-18e2be6767b9.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,"1,230 mg/m3",,rat Zirconium tetrapropanolate,23519-77-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/999af58c-adb0-4591-a0c8-81cd41303782/documents/5397ae84-0851-4444-a09a-c63491e1d4e8_cf9fbece-2ed3-43ab-b4c6-18e2be6767b9.html,Chronic toxicity – systemic effects,oral,NOAEL,"3,000 mg/kg bw/day",,rat Zirconium tetrapropanolate,23519-77-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/999af58c-adb0-4591-a0c8-81cd41303782/documents/7cc0a18d-e32d-4ddd-8b41-276784950d91_cf9fbece-2ed3-43ab-b4c6-18e2be6767b9.html,,oral,LD50,"6,500 mg/kg bw",no adverse effect observed, Zirconium tetrapropanolate,23519-77-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/999af58c-adb0-4591-a0c8-81cd41303782/documents/7cc0a18d-e32d-4ddd-8b41-276784950d91_cf9fbece-2ed3-43ab-b4c6-18e2be6767b9.html,,dermal,LD50,"4,032 mg/kg bw",no adverse effect observed, Zirconium tetrapropanolate,23519-77-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/999af58c-adb0-4591-a0c8-81cd41303782/documents/7cc0a18d-e32d-4ddd-8b41-276784950d91_cf9fbece-2ed3-43ab-b4c6-18e2be6767b9.html,,inhalation,LC50,"47,000 mg/m3",no adverse effect observed, Zirconium vanadium blue zircon,68186-95-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.RepeatedDoseToxicity.KeyValueForChemicalSafetyAssessment.RepeatedDoseToxicityViaOralRouteSystemicEffects.EndpointConclusion.DataBaseQuality): GLP-study reliable without restrictions. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/376f507a-361b-4e8a-a51a-10b186667b90/documents/IUC5-b02beb5e-cfe9-48d3-bf02-639e1244d831_e41eaaa5-e6ed-4640-ab3e-add44bd0a358.html,,,,,, Zirconium vanadium blue zircon,68186-95-8,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The study fulfils the rquirements for acute oral toxicity under REACH (Regulation (EC) 1907/2006). Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The study fulfils the requirements for acute inhalation toxicity under REACH (Regulation (EC) 1907/2006). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/376f507a-361b-4e8a-a51a-10b186667b90/documents/IUC5-2890241c-89be-4c39-863b-7826818b28b3_e41eaaa5-e6ed-4640-ab3e-add44bd0a358.html,,,,,, "Zirconium, acetate lactate oxo ammonium complexes",68909-34-2," No repeated dose toxicity study with zirconium, acetate lactate oxo ammonium complexes is available, thus the repeated dose toxicity will be addressed with existing data on the individual moieties zirconium, acetate, lactate and ammonium. In relevant and reliable repeated dose toxicity studies as well as supporting studies for the moieties of zirconium, acetate lactate oxo ammonium complexes, there were no toxicological findings reported that would justify a classification. Moreover, acetate, lactate and ammonium are used in medical and food products, and thus increased toxicity is not expected. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f6a10d99-0c0f-431e-bec3-a67bbbc8cfc0/documents/9e484e62-cc33-40a6-88dc-b6f35ccb7119_c38a1506-93f2-4328-9f01-74e8b361da28.html,,,,,, "Zirconium, acetate lactate oxo ammonium complexes",68909-34-2," No acute toxicity studies with zirconium, acetate lactate oxo ammonium complexes are available, thus the acute toxicity will be addressed with existing data on the dissociation products zirconium, acetate, lactate and ammonium. Acute dermal toxicity of the substance zirconium, acetate lactate oxo ammonium complexes is not expected, since the individual moieties zirconium, acetate, lactate and ammonium have not shown overt toxicity upon dermal exposure in experimental animal testing and in exposure related information in humans (for e.g. use in cosmetics). All dermal LD50 values available were found to be greater than 2000 mg/kg bw. The assessment entities zirconium, lactate and acetate have not shown adverse effects in experimental animal testing (all LD50 >2000 mg/kg bw). Additionally, lactate and acetate are found in physiological processes and are used in food products. Ammonium chloride, as representative of ammonium, oral LD50 values of 1410 mg/kg bw and 1300 mg/kg bw were determined for rats and male mice, respectively. Further, ammonium chloride has a legal classification for acute oral toxicity category 4 (Regulation (EC) No.1272/2008; Index No.: 017-015-00-8). ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f6a10d99-0c0f-431e-bec3-a67bbbc8cfc0/documents/31e6ccb3-cae7-4f94-a1c3-ba097f4d37d7_c38a1506-93f2-4328-9f01-74e8b361da28.html,,,,,, Tetrakis(isobutyrato)zirconium,12567-73-6,Oral acute toxicity: key study: results from a study report leading to the conclusion that LD50 is > 2000 mg/kg body weight. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a3ba75d2-d74a-4264-b777-ff91e9cf0165/documents/IUC5-f0d81574-fa5b-496c-86d5-fd388406e7cc_5bc08111-5824-44f7-a88c-e3b24a428434.html,,,,,, "α-(2,4-dichlorophenyl)-1H-imidazole-1-ethanol",24155-42-8," Acute oral toxicity: Key study. Method according to OECD TG 420, GLP study. Based on the results, the oral LD50 was found to be > 2000 mg/kg bw. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a55a3115-74ea-4575-85a5-060e8bba6ee6/documents/2f071cbd-49ea-4fdf-bfd6-fa95593f4504_b1a3f4a0-837f-45f3-9c19-4cbe9dc578fd.html,,,,,, "α,α,α',α'-tetramethyl-m-xylene-α,α'-diol",1999-85-5," There is no valid repeat dose study on the registered substance.  An apparently well conducted GLP 28-day study oral gavage study in rats, on the analog substance CAS# 27138-01-8 is considered the key study.   ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/a7d57e24-384d-4191-aef2-72cd40a1e372/documents/IUC5-2dce2b57-8d8f-4878-ae53-15f05228e565_c0af9fb7-a7d0-415b-b431-5dded6ecd284.html,,,,,, "α,α,α',α'-tetramethyl-m-xylene-α,α'-diol",1999-85-5, An acute oral study in rats is available and is considered the key study but reliable with restrictions. The test article was not toxic at the approximate limit dose of 2150 mg/kg. An acute dermal LD50 study on the analog substance is considered the key study.  The analog substance was not toxic at the limit dose of 2000 mg/kg. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7d57e24-384d-4191-aef2-72cd40a1e372/documents/IUC5-e8c3906a-78e8-41dd-a5eb-c9c107caf85f_c0af9fb7-a7d0-415b-b431-5dded6ecd284.html,,,,,, "α,α,α',α'-tetramethyl-m-xylene-α,α'-diol",1999-85-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7d57e24-384d-4191-aef2-72cd40a1e372/documents/IUC5-e8c3906a-78e8-41dd-a5eb-c9c107caf85f_c0af9fb7-a7d0-415b-b431-5dded6ecd284.html,,oral,discriminating dose,"2,150 mg/kg bw",no adverse effect observed, "α,α,α',α'-tetramethyl-m-xylene-α,α'-diol",1999-85-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7d57e24-384d-4191-aef2-72cd40a1e372/documents/IUC5-e8c3906a-78e8-41dd-a5eb-c9c107caf85f_c0af9fb7-a7d0-415b-b431-5dded6ecd284.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "α,α,α',α'-tetramethylxylene-α,α-diol",27138-01-8," In a 90-day study by oral route in rats, the NOAEL (No Observed Adverse Effect Level) was established at 1000 mg/kg/day in females and males, excluding the adverse lesions seen in male kidneys (a2u-globulin protein nephropathy-related findings) which are specific to male rats and with no relevance for human risk assessment. OECD 408 study The potential toxicity of m/p-DIOL was evaluated following daily oral administration (gavage) to rats for 13 weeks (Papineau, 2017). On completion of the treatment period, designated animals were held for a 6-week treatment-free period in order to evaluate the reversibility of any findings. This GLP study was carried out according to OECD test guideline No. 408 (21 September 1998). One group of 15 male and 15 female Sprague-Dawley rats was treated daily by the oral route (gavage) with the test item at the dose-level of 1000 mg/kg/day (group 4) for 13 weeks. Two other groups were treated with the test item at dose-levels of 50 (group 2: 10 males and 10 females) or 250 (group 3: 11 males and 10 females) mg/kg/day. One control group of 15 males and 15 females received the vehicle only (corn oil) under the same experimental conditions, and acted as a control group (group 1). A constant dosage volume of 5 mL/kg/day was used. At the end of the treatment period, the animals were sacrificed, except for the first five surviving group 1 and 4 animals per sex, which were kept for a 6-week treatment-free period. The actual test item concentrations in the dose formulations prepared for use in Weeks 1, 4, 8 and 11 were determined using a High Performance Liquid Chromatography with UV detection analytical method. The animals were checked daily for mortality and clinical signs. Detailed clinical examinations were performed weekly and a Functional Observation Battery (FOB) was conducted in Week 12. Body weight was recorded pre-test, on the first day of treatment and then once a week. Food consumption was recorded weekly. Ophthalmological examinations were performed on all animals before the beginning of the study and on control and high-dose animals at the end of the treatment period (Week 13). Hematology, blood biochemistry and urinary investigations were performed at the end of the treatment period (Week 13). Blood biochemistry and urinalysis parameters were also determined at the end of treatment-free period (Week 19). Additional blood samples were collected in Weeks 13 and 19 for possible analysis of thyroid hormone levels. The estrous cycle was determined over 21 or 14 consecutive days for all females at the end of the treatment or treatment-free period, respectively. At the end of the treatment period, seminology investigations (count and motility) were performed on all males, and morphology was determined in control and high-dose males. On completion of the treatment or treatment-free period, the animals were sacrificed and a full macroscopic post-mortem examination was performed. Designated organs were weighed and selected tissues were preserved. A microscopic examination (including testicular staging) was performed on designated tissues from control and high-dose animals sacrificed at the end of the treatment period and from animals that were euthanized prematurely, on all macroscopic lesions from all low- and intermediate-dose animals (groups 2 and 3) sacrificed on completion of the treatment period and on kidney slides immunostained with an antibody for a2u-globulinprotein from all control and high-dose males sacrificed at the end of the treatment period. The liver from low- and intermediate-dose main animals and from recovery animals, adrenals and kidneys from low- and intermediate-dose main males and from recovery males, and ovaries, vagina and uterus from low- and intermediate-dose main females and from recovery females were also microscopically examined as changes were revealed in these organs at the end of the treatment period. Actual concentrations of the test item in the dose formulations administered to the animals during the study remained within an acceptable range (-13.3% to -4.1%) compared to the nominal concentrations. There were no test item-related unscheduled deaths in any group. At 1000 mg/kg/day, non-adverse sporadic clinical signs were noted in 8/15 females (i.e. staggering gait, hypoactivity, hypotonia, half-closed eyes, dyspnea, abdominal breathing, slight tremors, hyperactivity and/or piloerection) during the treatment period. Ptyalism was observed with a dose-related incidence at all dose-levels. This sign, commonly observed when a test item is administered by gavage, was considered not to be adverse. The FOB results were unaffected by the test item treatment. Lower body weight gain was recorded in males given 250 mg/kg/day over the first 3 weeks of treatment (-15 to -18% vs. control) and in males given 1000 mg/kg/day throughout the treatment period (-13% vs. controls), leading to a minimally lower body weight on completion of the treatment period at 1000 mg/kg/day (-9% vs. controls). Reversibility of these differences was noted at the end of the treatment-free period. Food consumption was not affected by the test item treatment. No ophthalmology findings were observed at the end of the treatment period. A slight increase in the length of diestrus was observed in females given 1000 mg/kg/day at the end of the treatment period (6.5 days vs.6.0 days in controls). Variations were no longer observed at the end of the treatment-free period. The epididymal sperm motility and morphology, and the spermatozoa count were unaffected by the test item treatment. At hematology investigations, no test item-related effects were observed at the end of the treatment period. At blood biochemistry investigations, higher cholesterol was noted in females from 250 mg/kg/day. At the dose-level of 1000 mg/kg/day, lower glucose and higher creatinine levels were also noted in females, and lower potassium and chloride levels and higher urea level were recorded in males. All these changes were considered to be of minor toxicological importance as they were of minimal magnitude and within the range of the Historical Control Data for most of them. At urinary investigations, lower pH values were noted in males from 250 mg/kg/day and in females at 1000 mg/kg/day. At the dose-level of 1000 mg/kg/day, higher volume was recorded in females and higher density was noted in males. All these changes were considered to be of minor toxicological importance as they were isolated and/or within the range of the Historical Control Data. Reversibility of these blood biochemistry and urinalysis differences was noted at the end of the treatment-free period. There was a treatment-related statistically significant increase in absolute or relative weight of the following organs at the end of the treatment period: adrenals (males and females receiving 1000 mg/kg/day, correlating with cortical vacuolation at microscopic examination in males), kidney (males receiving 250 mg/kg/day or above, correlating with hyaline droplets), liver (males receiving 250 mg/kg/day or above and females receiving 1000 mg/kg/day, correlating with hepatocyte hypertrophy). There were no organ weight changes related to administration of the test item at the end of the treatment-free period. There were no test item-related necropsy findings. Test item related microscopic observations at the end of the treatment period consisted of the following: liver centrilobular hepatocyte hypertrophy, single cell necrosis, and bile duct fibrosis (males and females receiving 250 mg/kg/day m/p DIOL or above), adrenal cortical vacuolation (males receiving 1000 mg/kg/day), kidney hyaline droplets, shown to be a2u-globulin protein, in cortical tubular epithelium, tubular basophilia, hyaline casts (males receiving 50 mg/kg/day or above), female reproductive tract findings (ovarian luteal cysts, decrease in incidence of dilated uterine lumen, and vaginal mucification, squamous metaplasia and epithelial vacuolation in females receiving 250 mg/kg/day or above). Complete reversibility from microscopic observations seen at main necropsy occurred in liver (hypertrophy, bile duct fibrosis), kidneys (hyaline casts), and female reproductive tract (all findings). Partial reversibility occurred in the liver (single cell necrosis), adrenals (cortical vacuolation), kidneys (hyaline droplets, tubular basophilia). m/p DIOL related microscopic observations at recovery necropsy that were not present at main necropsy occurred in kidneys (granular casts). No microscopic changes were adverse except kidneys findings in males but which were without significance to humans.  Consequently, the NOAEL (No Observed Adverse Effect Level) was established at 1000 mg/kg/day in females and males if we exclude the adverse lesions seen in male kidneys (a2u-globulin protein nephropathy-related findings) which are specific to male rats and with no relevance for human risk assessment. OECD 407 study In an OECD 407 study, GLP compliant (Betnz, 2012), four groups of five male and five female Sprague-Dawley rats received m/p-DIOL by daily oral administration for 28 days at dose-levels of 0, 100, 300 or 1000 mg/kg/day in corn oil. The animals were checked at least twice daily during the dosing period for mortality and morbidity and once daily for clinical signs. In addition, detailed clinical examinations were performed at least once weekly. Body weight was recorded once before the beginning of the treatment period, and then at least once a week during the study as food consumption. Towards the end of the dosing period, a Functional Observation Battery, motor activity measurement, hematology and blood biochemistry were performed on all animals. On completion of the treatment period, the animals were euthanized and submitted to a full macroscopic post-mortem examination. Designated organs were weighed and selected tissues were preserved. A microscopic examination was performed on selected tissues from control- and high-dose animals and on kidneys, liver and adrenals from the low- and intermediate-dose animals sacrificed at the end of the treatment period, as well as on all macroscopic lesions.  There were no unscheduled deaths during the study. Piloerection and staggering gait were observed at the very beginning of the treatment period in 4/10 animals treated at 1000 mg/kg/day and ptyalism was noted in all animals from this group. These clinical signs were considered to be test item-related but non adverse. Although the observation was not required in the study, water consumption was noticed to be higher towards the middle of the treatment period in a dose-related manner at 300 and 1000 mg/kg/day. There were no test item-related effects at FOB motor activity or on mean body weight and mean body weight changes. There were no toxicologically relevant effects on mean food consumption and mean hematology parameters. Slight non-adverse effects were noted in clinical chemistry at 1000 mg/kg/day and were considered as of minor toxicological relevance (cholesterol level, mean protein and albumin). Mean liver (from +28 to +34% from controls, p<0.01), kidney (up to +23% in males with p<0.01, +10% in females with p<0.05 for the mean relative weight) and adrenal (up to +16%) weights were higher in males and/or females given 1000 mg/kg/day. There were no test item-related macroscopic findings. Microscopic findings were seen in liver (non adverse hepatocellular hypertrophy in 5/5 males and 2/5 females at 1000 mg/kg/day), kidney (hyaline droplets in 4/5 and 5/5 males at 300 and 1000 mg/kg/day, respectively, together with an increase in tubular basophilia in 3/5 males at 1000 mg/kg/day considered as adverse, tubular dilation and infiltrate of mononuclear cells), and adrenals (non adverse increased vacuolation in 2/5 males at 1000 mg/kg/day). Under the experimental conditions of this study, the No Observed Adverse Effect Level (NOAEL) of m/p-DIOL was considered to be at 1000 mg/kg/day in males and females excluding the adverse lesions seen in male kidneys (a2u-globulin protein nephropathy-related findings) which are specific to male rats and with no relevance for human risk assessment. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d941200-b1fa-4595-8fbf-6d684987aa96/documents/IUC5-37077e72-e344-463c-94e3-496d41fa1f39_23784626-1876-4e41-8776-8e33a9876e2c.html,,,,,, "α,α,α',α'-tetramethylxylene-α,α-diol",27138-01-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/6d941200-b1fa-4595-8fbf-6d684987aa96/documents/IUC5-37077e72-e344-463c-94e3-496d41fa1f39_23784626-1876-4e41-8776-8e33a9876e2c.html,Sub-chronic toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "α,α,α',α'-tetramethylxylene-α,α-diol",27138-01-8," Acute oral toxicity For this endpoint, there is no data on the isomer mixture. The acute oral toxicity of the meta isomer was evaluated in Wistar rats according to OECD N°401 guideline, but not in compliance with GLP (Wang, 2012a). Groups of 5 male and 5 female Sprague Dawley rats were given a,a,a’,a’-tetramethyl-m-xylene-a,a’-diol in corn oil by oral exposure at doses of 464, 1000, 2150 and 4640 mg/kg for female and 1000, 2150, 4640 and 10000 mg/kg for male. Following treatment, rats were observed daily and weighted on days 3, 7 and 14. A gross necropsy examination was performed at the time of scheduled euthanasia (Day 14). The signs such as activity decreased, limb weakness, side position, dyspnea, issued open mouth breathing were observed in the higher dose groups (21500 and 10000 mg/kg) about 10 minutes after treatment. Death occurred within 4 hour after exposure (mortality was observed from 4640 mg/kg both in males and in females). The rats in the 4640 mg/kg dose group showed slighter signs and the number of deaths was less than the higher dose groups above. No toxic signs and death occurred in the 2150 and 1000 mg/kg dose groups. The survival animals recovered within 24 hours after exposure. At necropsy, pulmonary hemorrhage and congestion of the liver were observed in dead animals only. The LD50 was 4300  mg/kg for female rats and 5010 mg/kg for male rats, and around 4655 mg/kg for both males in females.   The oral LD50 of the meta and para isomers was evaluated using QSAR models. In the Danish QSAR database, the estimated LD50 was 3700 mg/kg for both isomers. Using the Toxicity Estimation Software Tool (T.E.S.T), LD50 3761 and 3326 mg/kg were estimated for the meta and para isomers, respectively. Globally, the acute oral LD0 of m/p-DIOL is estimated to be higher than 2000 mg/kg.   Acute dermal toxicity The acute dermal toxicity of m/p-DIOL was assessed in Sprague-Dawley rats, following the OECD 402 guideline and in compliance with GLP (Silvano, 2012). The test item was applied in its original form (pre-moistened) to the skin of five female then five male Sprague-Dawley rats at the dose-level of 2000 mg/kg. The application site was covered by a semi-occlusive dressing for 24 hours. Each animal was observed at least once a day for mortality and clinical signs for 15 days. From day 2, any local reactions at the treatment site were also noted. Body weight was recorded on day 1 and then on days 8 and 15. On completion of the observation period, the animals were sacrificed and then submitted for a macroscopic post-mortem examination. No tissues were preserved. No unscheduled deaths and no clinical signs indicative of systemic toxicity were observed in any animals. No cutaneous reactions were observed in any animals. When compared to historical control data, a lower body weight gain was noted in all females between day 1 and day 8. Their body weight gain returned to normal thereafter. Body weight of males was unaffected by the test item treatment. There were no macroscopic findings in any animals. In conclusion the dermal LD0 of m/p-DIOL is higher than 2000 mg/kg in rats. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d941200-b1fa-4595-8fbf-6d684987aa96/documents/IUC5-529a1ab8-6b60-40a9-bd08-d811681aebdb_23784626-1876-4e41-8776-8e33a9876e2c.html,,,,,, "α,α,α',α'-tetramethylxylene-α,α-diol",27138-01-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d941200-b1fa-4595-8fbf-6d684987aa96/documents/IUC5-529a1ab8-6b60-40a9-bd08-d811681aebdb_23784626-1876-4e41-8776-8e33a9876e2c.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "α,α,α',α'-tetramethylxylene-α,α-diol",27138-01-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6d941200-b1fa-4595-8fbf-6d684987aa96/documents/IUC5-529a1ab8-6b60-40a9-bd08-d811681aebdb_23784626-1876-4e41-8776-8e33a9876e2c.html,,dermal,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, "α,α,α-trifluoro-3-tolyl isocyanate",329-01-1,"A not assignable oral repeated dose study in mice cited from ECB IUCLID Dataset ID: 329-01-1, and repeated inhalation studies in rats and mice from a secondary source (only abstract available; original reference in Russian) are available. Additionally results froma secondary source on dermal toxicity (skin effects) are cited. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9158eace-52bc-485d-9a53-a22aa1d34deb/documents/IUC5-80ef8ed9-19e1-4511-bbcf-0078626af92e_b60e43f6-3f26-4a08-baa4-aefd74972283.html,,,,,, "α,α,α-trifluoro-3-tolyl isocyanate",329-01-1,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/9158eace-52bc-485d-9a53-a22aa1d34deb/documents/IUC5-80ef8ed9-19e1-4511-bbcf-0078626af92e_b60e43f6-3f26-4a08-baa4-aefd74972283.html,Short-term repeated dose toxicity – systemic effects,inhalation,NOAEC,1.3 mg/m3,, "α,α,α-trifluoro-3-tolyl isocyanate",329-01-1," A reliable acute oral toxicity study is available for evaluation. Several acute inhalation studies were conducted. For the most reliable study (Hoechst, 1992) a LC50 = 79 mg/m³ is stated based on an expert statement of Prof. Pauluhn. The LC50 = 79 mg/m³ is taken for risk assessment. The acute dermal toxicity study is not assignable (reliability 4) because only data from a secondary source are available. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9158eace-52bc-485d-9a53-a22aa1d34deb/documents/IUC5-0d157b51-a0c1-41b7-95e8-69b96fe55a58_b60e43f6-3f26-4a08-baa4-aefd74972283.html,,,,,, "α,α,α-trifluoro-3-tolyl isocyanate",329-01-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9158eace-52bc-485d-9a53-a22aa1d34deb/documents/IUC5-0d157b51-a0c1-41b7-95e8-69b96fe55a58_b60e43f6-3f26-4a08-baa4-aefd74972283.html,,oral,LD50,"6,604 mg/kg bw",adverse effect observed, "α,α,α-trifluoro-3-tolyl isocyanate",329-01-1,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/9158eace-52bc-485d-9a53-a22aa1d34deb/documents/IUC5-0d157b51-a0c1-41b7-95e8-69b96fe55a58_b60e43f6-3f26-4a08-baa4-aefd74972283.html,,inhalation,LC50,79 mg/m3,adverse effect observed, "α,α,α-trifluoro-m-toluidine",98-16-8,"Sanders (2011), OECD 420: Acute Oral tox. Category 4 Khalepo (1968), Acute oral toxicity rat: Inconclusive  Khalepo (1968), Acute Oral toxicity mouse: Inconclusive Khalepo (1968), Acute Oral toxicity rabbit: Inconclusive Khalepo (1968), Acute Inhalation toxicity rat: Inconclusive Khalepo (1968), Acute Inhalation toxicity mouse: Inconclusive Khalepo (1968), Acute dermal toxicity rabbit: Inconclusive  The in vivo acute toxicity studies conduced by Khalepo 1968 were not conclusive for classification therefore the classification of the test substance required the use of an additional in vivo study. The results from the in vivo OECD TG 420 were sufficient to classify the test item to be an acute tox oral Category 4 classification in accordance to the CLP Regulation (EC) No 1272/2008.  Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): The experimental study (Sanders, 2011) satisfies the information requirements under REACH. The three acute toxicity via the oral route studies published under Khalepo (1968) did not satisfy the information requirements under REACH. The studies were all scored as Klimisch 4 (not assignable) therefore no endpoint conclusion could be reached. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaInhalationRoute.EndpointConclusion.DBQuality): The two acute toxicity via inhalation route studies published under Khalepo (1968) did not satisfy the information requirements under REACH. The studies were all scored as Klimisch 4 (not assignable) therefore no endpoint conclusion could be reached. Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaDermalRoute.EndpointConclusion.DataBaseQuality): The acute dermal via dermal route study published under Khalepo (1968) did not satisfy the information requirements under REACH. The studies were all scored as Klimisch 4 (not assignable) therefore no endpoint conclusion could be reached. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6cae215c-e3f5-4c2a-b86e-7897aed04769/documents/9b18dd12-f592-437f-a4ea-2fb02a7fc528_cff329e5-942d-486a-b3ee-bc1a64ca0a81.html,,,,,, "α,α,α-trifluoro-m-toluidine",98-16-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/6cae215c-e3f5-4c2a-b86e-7897aed04769/documents/9b18dd12-f592-437f-a4ea-2fb02a7fc528_cff329e5-942d-486a-b3ee-bc1a64ca0a81.html,,oral,LD50,> 300 mg/kg bw,adverse effect observed, "α,α,α-trifluoro-o-toluoyl chloride",312-94-7,"Migrated Data from field(s) Field ""Quality of whole database"" (Path: ENDPOINT_SUMMARY.AcuteToxicity.KeyValueForChemicalSafetyAssessment.AcuteToxicityViaOralRoute.EndpointConclusion.DataBaseQuality): Limited methodological detail is provided; however the study is considered to be sufficiently reliable for the purposes of classification and labelling. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2dd7fa4c-4ca4-4b21-9eaa-5ee8196b4ecd/documents/IUC5-9a03fedf-c26b-4644-aa25-e2ebca6c6bb3_5b55a241-3b54-4393-9ee7-4f1ec9b80d80.html,,,,,, "α,α,α-trifluoro-o-toluoyl chloride",312-94-7,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/2dd7fa4c-4ca4-4b21-9eaa-5ee8196b4ecd/documents/IUC5-9a03fedf-c26b-4644-aa25-e2ebca6c6bb3_5b55a241-3b54-4393-9ee7-4f1ec9b80d80.html,,oral,LD50,"8,200 mg/kg bw",no adverse effect observed, "α,α,α-trifluorotoluene",98-08-8,"The repeated toxicity of trifluoromethylbenzene has been investigated in a combined repeated dose toxicity study with the reproduction/developmental toxicity screening test [OECD TG 422 (proposal)]. The substance was administered via gavage to male and female rats at 0, 20, 100 or 500 mg/kg bw/day. The duration of treatment in males was 49 days including a 14-day pre-mating period. Females were dosed for a 14-day pre-mating period, during mating and gestation periods, and until day 3 of lactation. One female died after delivery on day 23 of gestation in the 500 mg/kg bw/day group. No other treatment-related clinical signs of toxicity were observed. No effects were found on body weight and food consumption. Hematological and blood biochemical examination performed in males only revealed a decrease in glucose and increases in total protein, albumin, total cholesterol, phospholipid and calcium at 500 mg/kg bw/day. The absolute and/or relative liver weight was increased in males in the 100 mg/kg bw/day group and in both sexes in the 500 mg/kg bw/day group, and histopathological examination revealed centrilobular hypertrophy of hepatocytes at 100 mg/kg bw/day and more in both sexes. In males, increased absolute and relative kidney weights were also found in the 500 mg/kg bw/day group, and microscopic changes in the kidney (hyaline droplets, epithelial necrosis, dilatation and basophilic changes in the epithelium of proximal tubules) were observed at 100 mg/kg bw/day and higher. Based on the histopathological changes in the liver and kidneys, NOAEL for repeated dose oral toxicity was considered to be 20 mg/kg bw/day for both sexes. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fde0e53c-2a5e-4d67-95ba-33333709be4f/documents/bf19c633-f38d-471f-8e6e-3ec640ae2faa_3f8a261a-e557-440a-8833-97ca52a4a0d2.html,,,,,, "α,α,α-trifluorotoluene",98-08-8,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/fde0e53c-2a5e-4d67-95ba-33333709be4f/documents/bf19c633-f38d-471f-8e6e-3ec640ae2faa_3f8a261a-e557-440a-8833-97ca52a4a0d2.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,20 mg/kg bw/day,,rat "α,α,α-trifluorotoluene",98-08-8,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/fde0e53c-2a5e-4d67-95ba-33333709be4f/documents/2e998237-8f25-4b40-8be9-3df2f6b5acdb_3f8a261a-e557-440a-8833-97ca52a4a0d2.html,,dermal,LD50,"> 2,000 mg/kg bw",no adverse effect observed, "α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol",6786-83-0,"Repeated dose toxicity oral OECD 422 (GLP, Klimisch 1): NOAEL was considered to be 25 mg/kg bw/day (low dose) in both male and female rats. At 50 mg/kg bw/day (mid dose), dullness was observed in 3 male rats and in 1 female rat, and significant changes in the functional observatory battery (FOB) were observed in the male rats. At 75 mg/kg bw/day (top dose), all male and female animals showed dullness and significant changes in the FOB were observed in both genders. The dulless was found to be persistent during the dosing period, but reversible upon cessation of treatment based on the results from the recovery groups. The effects on the FOB were also considered to be reversible upon cessation of treatment as no significant changes in FOB were observed after recovery.   OECD 407 (GLP, Klimisch 2): LOAEL was considered to be 50 mg/kg bw/day in both male and female rats based on clinical signs of toxicity in both genders (vocalization on handling, dullness, hunched posture) and significant changes in the functional observatory battery in female rats (decreased locomotor activity). Animals treated at 150 mg/kg died on day 4, 5, 7, 8 or 11 of treatment whereas animals treated at 450 mg/kg died on day 3, 4 or 5 of treatment. A NOAEL value in the study could not be established.     Repeated Dose toxicity inhalation A short term toxicity study need not be conducted because of exposure of humans via inhalation in production and/or in use is not likely based on the thorough and rigorous exposure assessment. The vapor pressure of the test chemical was reported to be 2.01E-17 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore, this study is considered for waiver.    Repeated Dose toxicity dermal A short term toxicity study need not be conducted because of exposure of humans via dermal route n production and/or in use is not likely based on the thorough and rigorous exposure assessment.  The acute toxicity value for test chemical (as provided in section 7.2.3) is >2000 mg/kg body weight. Also, given the use of the chemical; repeated exposure by the dermal route is unlikely since the use of gloves is common practice in industries. Therefore, this study is considered for waiver ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/704d3de6-25e5-43fa-8faf-eb86a3c5d8b7/documents/176310c7-60ff-463e-82fe-91e32183d348_7bedaecb-9fef-47d3-90d3-979c8bc70725.html,,,,,, "α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol",6786-83-0,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/704d3de6-25e5-43fa-8faf-eb86a3c5d8b7/documents/176310c7-60ff-463e-82fe-91e32183d348_7bedaecb-9fef-47d3-90d3-979c8bc70725.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,25 mg/kg bw/day,,rat "α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol",6786-83-0,"Acute oral toxicity:    The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the given test chemical. The studies concluded that the LD50 value is >2000 mg/kg bw, for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute oral toxicity.   Acute Inhalation Toxicity:   The acute inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 2.01E-17 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study is considered for waiver.    Acute Dermal toxicity:   The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw, for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/704d3de6-25e5-43fa-8faf-eb86a3c5d8b7/documents/16bd9637-daf4-4a68-93a2-ef62a8ca9946_7bedaecb-9fef-47d3-90d3-979c8bc70725.html,,,,,, "α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol",6786-83-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/704d3de6-25e5-43fa-8faf-eb86a3c5d8b7/documents/16bd9637-daf4-4a68-93a2-ef62a8ca9946_7bedaecb-9fef-47d3-90d3-979c8bc70725.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, "α,α-bis[4-(dimethylamino)phenyl]-4-(phenylamino)naphthalene-1-methanol",6786-83-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/704d3de6-25e5-43fa-8faf-eb86a3c5d8b7/documents/16bd9637-daf4-4a68-93a2-ef62a8ca9946_7bedaecb-9fef-47d3-90d3-979c8bc70725.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "α,α-dimethylbenzyl hydroperoxide",80-15-9,The highest no adverse effect concentration in a 3-month toxicity study by inhalation was found to be 31 mg/m3 which is equivalent to 5 ppm vapor exposure. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7007930a-9668-4a91-960b-07fb62080910/documents/IUC5-08bf3eb6-296c-455e-9e80-adf9a70a1ed7_c535e204-cfed-4d2e-9641-417cb686f042.html,,,,,, "α,α-dimethylbenzyl hydroperoxide",80-15-9,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7007930a-9668-4a91-960b-07fb62080910/documents/IUC5-08bf3eb6-296c-455e-9e80-adf9a70a1ed7_c535e204-cfed-4d2e-9641-417cb686f042.html,Sub-chronic toxicity – systemic effects,inhalation,NOAEC,31 mg/m3,,rat "α,α-dimethylbenzyl hydroperoxide",80-15-9,Data from studies performed according to current guidelines are not available. Information from older studies has been assessed in a weight of evidence approach. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7007930a-9668-4a91-960b-07fb62080910/documents/IUC5-15a5927a-7f6c-4635-9a12-65cefc943b63_c535e204-cfed-4d2e-9641-417cb686f042.html,,,,,, "α,α-dimethylbenzyl hydroperoxide",80-15-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7007930a-9668-4a91-960b-07fb62080910/documents/IUC5-15a5927a-7f6c-4635-9a12-65cefc943b63_c535e204-cfed-4d2e-9641-417cb686f042.html,,oral,LD50,382 mg/kg bw,, "α,α-dimethylbenzyl hydroperoxide",80-15-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7007930a-9668-4a91-960b-07fb62080910/documents/IUC5-15a5927a-7f6c-4635-9a12-65cefc943b63_c535e204-cfed-4d2e-9641-417cb686f042.html,,dermal,LD50,134 mg/kg bw,, "α,α-dimethylbenzyl hydroperoxide",80-15-9,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7007930a-9668-4a91-960b-07fb62080910/documents/IUC5-15a5927a-7f6c-4635-9a12-65cefc943b63_c535e204-cfed-4d2e-9641-417cb686f042.html,,inhalation,LC50,"1,370 mg/m3",, "α,α'-propylenedinitrilodi-o-cresol",94-91-7,Based on the results of a OECD 422 study: NOAEL(systemic) > 250 mg/kg bw/day; NOAEL(local): > 75 mg/kg bw/day ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7780ac4d-96f1-4e64-8035-a2e3b7b6e7d2/documents/IUC5-421e7647-ee88-4185-be0f-3faeb369b5bd_f9a9dfb9-a04e-41dd-9d90-59af0d945e4b.html,,,,,, "α,α'-propylenedinitrilodi-o-cresol",94-91-7,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/7780ac4d-96f1-4e64-8035-a2e3b7b6e7d2/documents/IUC5-421e7647-ee88-4185-be0f-3faeb369b5bd_f9a9dfb9-a04e-41dd-9d90-59af0d945e4b.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,250 mg/kg bw/day,,rat "α,α'-propylenedinitrilodi-o-cresol",94-91-7,"LD50 (oral) ca. 1350 mg/kg bw (BASF AG, 1967)LD50 (dermal) > 2000 mg/kg bw (BASF SE, 2012) ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7780ac4d-96f1-4e64-8035-a2e3b7b6e7d2/documents/IUC5-605e19f6-3843-497a-8c93-0be88516a1f4_f9a9dfb9-a04e-41dd-9d90-59af0d945e4b.html,,,,,, "α,α'-propylenedinitrilodi-o-cresol",94-91-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7780ac4d-96f1-4e64-8035-a2e3b7b6e7d2/documents/IUC5-605e19f6-3843-497a-8c93-0be88516a1f4_f9a9dfb9-a04e-41dd-9d90-59af0d945e4b.html,,oral,LD50,"1,350 mg/kg bw",adverse effect observed, "α,α'-propylenedinitrilodi-o-cresol",94-91-7,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/7780ac4d-96f1-4e64-8035-a2e3b7b6e7d2/documents/IUC5-605e19f6-3843-497a-8c93-0be88516a1f4_f9a9dfb9-a04e-41dd-9d90-59af0d945e4b.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, "α-Bitter acids, hop, hydrogenated, isomerized",92113-15-0,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/23e25d19-6829-4d38-92f7-e9d335b90483/documents/53f905a7-3316-422f-9ab2-82c4cfd71c0d_7f771106-bb77-4b5e-bba3-900ac52e8cc2.html,,oral,LD50,"1,000 mg/kg bw",adverse effect observed, α-bromo-m-toluonitrile,28188-41-2," Acute Oral Toxicity:  Acute oral toxicity dose was predicted based on OECD QSAR toolbox for target substance α-bromo-m-toluonitrile (28188-41-2) was estimated to be 2439.03 mg/kg bw for rats,and for differentstudies available on target substance α-bromo-m-toluonitrile (28188-41-2) using the Danish (Q)SAR Database was estimated to be 2700 mg/kg bw for rats;for the structurally similar read across substance4-methylbenzonitrile (104-85-8)was considered to be 3800 mg/kg bw for rats and for the closely related read across substance 1-Bromobutane (109-65-9) was considered to be 2761 mg/kg bw for rats. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, α-bromo-m-toluonitrile (28188-41-2) can be classified as category V of acute oral toxicity. Acute Dermal Toxicity: Acute dermal toxicity dose was predicted based on OECD QSAR toolbox for target substance α-bromo-m-toluonitrile (28188-41-2) was estimated to be 2663.34 mg/kg bw for rabbits,and for differentstudies available on structurally similar read across substance 1,3-Benzenedicarbonitrile (626-17-5) was considered to be >2000 mg/kg bw for rabbits and for the closely related read across substance 2,2-dichloro-1,1,1-trifluoroethane (306-83-2) was considered to be >2000 mg/kg bw for rabbits. All these studies concluded that the LD50 value is greater than 2000 mg/kg bw. Thus, comparing this value with the criteria of CLP regulation, α-bromo-m-toluonitrile (28188-41-2) was can be classified as category V of acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1f858c0-48cd-4cb8-92ba-d80eb17e6bdd/documents/3111b3bf-3aae-469b-b56d-a6e3ff2b7135_13fd8dc0-a0e9-4ca8-8fcd-d7d95167e620.html,,,,,, α-bromo-m-toluonitrile,28188-41-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1f858c0-48cd-4cb8-92ba-d80eb17e6bdd/documents/3111b3bf-3aae-469b-b56d-a6e3ff2b7135_13fd8dc0-a0e9-4ca8-8fcd-d7d95167e620.html,,oral,LD50,"2,439.03 mg/kg bw",no adverse effect observed, α-bromo-m-toluonitrile,28188-41-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/e1f858c0-48cd-4cb8-92ba-d80eb17e6bdd/documents/3111b3bf-3aae-469b-b56d-a6e3ff2b7135_13fd8dc0-a0e9-4ca8-8fcd-d7d95167e620.html,,dermal,LD50,"2,663.34 mg/kg bw",no adverse effect observed, α-methylcyclohexanepropanol,10528-67-3, The acute oral LD50 was determined to be > 2000 mg/kg b.w. in rats. ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47d7c323-04b0-4de4-af63-3535253f33be/documents/IUC5-c236f128-5412-4202-bf1a-0da62ebb86b6_37fcb5dd-db65-42ec-8ccf-53de515a8d52.html,,,,,, α-methylcyclohexanepropanol,10528-67-3,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/47d7c323-04b0-4de4-af63-3535253f33be/documents/IUC5-c236f128-5412-4202-bf1a-0da62ebb86b6_37fcb5dd-db65-42ec-8ccf-53de515a8d52.html,,oral,discriminating dose,"2,000 mg/kg bw",no adverse effect observed, α-methylenebenzyl acetate,2206-94-2,"The key study for acute oral toxicity, which was conducted according to OECD TG 420 and in compliance with GLP, reports an LD50 value of >2000 mg/kg bw (Hameln, 2015). ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eecbb118-8d17-4209-a517-dc98f4d4213b/documents/IUC5-f4ef1657-a3ec-4d85-8e10-bc5996990e8d_774c9786-56c5-4ff8-a9fd-8d9bf047e4f2.html,,,,,, α-methylenebenzyl acetate,2206-94-2,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/eecbb118-8d17-4209-a517-dc98f4d4213b/documents/IUC5-f4ef1657-a3ec-4d85-8e10-bc5996990e8d_774c9786-56c5-4ff8-a9fd-8d9bf047e4f2.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, α-phenyl-1H-benzimidazole-2-methanol,50-97-5, NOAEL (systemic toxicity) = 750 mg/kg bw/d; OECD 422; S. Fulcher. (2019) ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0ddea89-5fba-4463-9c20-9fd242a98b4e/documents/1654bae3-4917-496d-a45c-94a1d74faea3_618bb299-795e-4afd-af07-90904f2649e8.html,,,,,, α-phenyl-1H-benzimidazole-2-methanol,50-97-5,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/f0ddea89-5fba-4463-9c20-9fd242a98b4e/documents/1654bae3-4917-496d-a45c-94a1d74faea3_618bb299-795e-4afd-af07-90904f2649e8.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,750 mg/kg bw/day,,rat α-phenyl-1H-benzimidazole-2-methanol,50-97-5," Acute Toxicity: Oral: LD50 = > 2,000 mg/kg bw; OECD 420; Blair Yasso., 2017 Acute Toxicity: Inhalation: Waiver Acute Toxicity: Dermal: LD50 = > 2,000 mg/kg bw; OECD 402; A Sanders., 2018 ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0ddea89-5fba-4463-9c20-9fd242a98b4e/documents/35a3cfdc-536c-47e4-8934-f0c87a712068_618bb299-795e-4afd-af07-90904f2649e8.html,,,,,, α-phenyl-1H-benzimidazole-2-methanol,50-97-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0ddea89-5fba-4463-9c20-9fd242a98b4e/documents/35a3cfdc-536c-47e4-8934-f0c87a712068_618bb299-795e-4afd-af07-90904f2649e8.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed, α-phenyl-1H-benzimidazole-2-methanol,50-97-5,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/f0ddea89-5fba-4463-9c20-9fd242a98b4e/documents/35a3cfdc-536c-47e4-8934-f0c87a712068_618bb299-795e-4afd-af07-90904f2649e8.html,,dermal,LD50,"2,000 mg/kg bw",no adverse effect observed, α-phenylpyridine-2-acetonitrile,5005-36-7,"ACD/Percepta model for acute oral toxicity on mouse and rat provides LD50 predictions by oral administration route, based on the GALAS methodology. Reliability of predictions is estimated in terms of reliability index (RI), which ranges from 0 to 1 and takes into account the similarity of the Phenyl(pyridin-2-yl)acetonitrile with the training set compounds and the consistency of experimental values for similar compounds. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/5507f4b9-e49c-46da-9a15-d859d918c7d1/documents/IUC5-3411f426-c269-4d7c-9ab5-e742cb21806d_4622e928-d644-4a22-8570-7782ede1cba0.html,,,,,, "β-Alanine, N-C8-18-alkyl derivs., monopotassium salts",90170-42-6,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/b96c874c-7cd4-4e88-89f0-7dbbe3c3182d/documents/IUC5-e96c2798-35e5-48cc-b964-f2ecbb3982f1_c9dcf0a4-7c32-4225-8d30-03f183a9df69.html,Short-term repeated dose toxicity – systemic effects,oral,,"1,000 mg/kg bw/day",,rat "β-Alanine, N-C8-18-alkyl derivs., monopotassium salts",90170-42-6,"Read across from sodium salt, sodium β-Alanine, N-C8-18-alkyl derivs. EC 305-318-6The oral LD50 study on Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6 has reliability rating 2 and the procedure used meets the requirements of the limit test for acute oral toxicity described by the OECD Guideline 401. The results of this GLP compliant study indicate that the test material has little toxic effect when administered as a single oral dose to the rat at a dose level of 5000 mg/kg bw. The test material used consists of 40% active ingredient and 60% water. As the oral LD50 of the product is > 5000 mg/kg bw, the LD50 of the active ingredient is considered to be > 2000 mg/kg bw. The dermal LD50 study (OECD Guideline 402) on Sodium N-(2-carboxyethyl)-N-(2-ethylhexyl)-β-alaninate, CAS No 94441-92-6 is performed according to GLP and has reliability rating 1. It is therefore considered acceptable for classification and labelling purposes. The LD50 of the active ingredient is considered to be > 2000 mg/kg bw, and it does not have to be classified and has no obligatory labelling requirement for acute dermal toxicity. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/b96c874c-7cd4-4e88-89f0-7dbbe3c3182d/documents/IUC5-cdd56d03-ae34-4894-b6b5-ab32b0275930_c9dcf0a4-7c32-4225-8d30-03f183a9df69.html,,,,,, β-bromostyrene,103-64-0," Repeated dose toxicity: Oral In a Subacute repeated dose oral toxicity study, Sprague Dawley [Crl:CD()SD] male and female rats treated with the test chemical orally by gavage in the concentration of 0 (corn oil), 30, 125 and 500 mg/kg/day for 28 days. Recovery group animals for a duration of 14 days were also included in the study other than the test group animals. The animals were observed for clinical signs, mortality, changes in body weight, food and water consumption, urinanalysis, hematology, clinical chemistry, neurobehavioral parameters were noted and the animals were sacrificed for gross and histo-pathology One female rat was found dead on Day 3 and Decreases in spontaneous movement during weeks 3 and 4 were observed in male and female rats. No clinical signs were observed in any animal during the recovery period. Significantly increased body weight was observed in female rat on days 17-24 during the dosing period and significant decrease in water consumption was observed in female rats during week 4 of the dosing period a 125 mg/kg/day dose group as compared to control. Significant decreased in food consumption at day 4 were observed in male and female rat in dosing period and in females at days 7 and 14 in recovery period at 500 mg/kg/day and significant increased in food consumption at days 7-21 were observed in female rats at 125 mg/kg/day as compared to control. Decreased mean corpuscular hemoglobin (MCH) during dosing and eosinophils in recovery period were observed in male rat and increased reticulocyte and decreased mean corpuscular hemoglobin concentration (MCHC) during dosing and increase monocytes at recovery period were observed in female rats and significant increased in total protein level in male and female rats, Ca, P and albumin level and decrease in aspartate aminotransferase, alanine aminotransferase, lactate dehydrogenase and creatinine in male rats and significant increased in total cholesterol, triglycerides, phospholipids and Cl level in female rats at the end of dosing. Significant increased in triglycerides level was observed in female rats after the recovery period at 500 mg/kg/day. Decreased activated partial thromboplastin time and increased fibrinogen level were observed in female rats andsignificant decrease in aspartate aminotransferase, lactate dehydrogenase level and significant increased in Ca level in male rats and significant increased in total cholesterol, phospholipids level in female rats observed at 125 mg/kg/day as compared to control. Significant increases in urine volume in male and female rats, decrease in urine osmolality and small round epithelial cells in sediments were observed in male rats during week 4 of dosing period at 500 mg/kg/day and significant increases in urine volume and significant decrease in urine osmolality were observed in male rats at 125 mg/lg/day as compared to control. No significant differences were seen in urine volume, osmolality and qualitative measurements for either sex compared with the control groups during week 2 of the recovery period. Significant decrease in landing foot splay and forelimb grip strength was observed in male rats during week 2 of the recovery period. However, it was determined to be incidental because this sign was not observed during week 4 of the dosing period at 500 mg/kg/day. Significant decrease in forelimb grip strength was observed in male rats during week 2 of recovery period. No significant change was observed in any male and female rats receiving the test substance during week 4 of the dosing period. Significant increase in hindlimb grip strength was observed in female rats during week 4 of the dosing period at 125 mg/kg/day as compared to control. However, this was not observed in the high dose group. Similarly, Significant increase in absolute and relative liver weight in male and female rats, significant increase in absolute and relative kidney weights and significant decrease in absolute testes weight in male rats and significant increase in relative kidney weights in female rats in dosing period and significant increase in relative liver and heart weight was observed in female rats at 500 mg/kg/day as compared to control at the end of recovery period. Significant increase in relative liver weight and decrease in brain weight were observed at 125 mg/kg/day in female rats at the end of the recovery period. In addition, excess fluids in the abdominal and thoracic cavities, an enlarged liver, and dark red foci in the glandular stomach and unilateral small thyroids observed in female rat and enlargement of liver was observed in male rats at the end of dosing period. Enlargement of liver was observed in male rats at the end of recovery period in 500 mg/lg/day. Dark red foci in lung in one male rat and dark red foci in the glandular stomach in one female rat were observed at end of the dosing period at 125 mg/kg/day dose group. Minimal to mild degree of eosinophilic bodies in tubular cells, Mild degeneration of renal tubular and minimal hyaline casts in kidneys, minimal to mild centrilobular hypertrophy of hepatocytes in liver and minimal hypertrophy of follicular cells in thyroids were observed in male rats and atrophy of Peyer’s patch in the ileum, dilation of the renal tubes with centrilobular necrosis and congestion in the liver, focal hemorrhage and accumulation of foamy cells in the lung, atrophy of the mesenteric and submandibular lymph nodes, an increase in hematopoiesis and atrophy of white pulp in the spleen, erosion in the glandular stomach, atrophy of the thymus, and a remnant of ultimobranchial bodies in the thyroid were observed in female rats at 500 mg/kg/day as compared to control. Minimal Tubular regeneration, mild to minimal Eosinophilic body in tubular cells interstitial mineralization Kidney and Hypertrophy of follicular cells in thyroid of male rat and Periportal vacuolation of hepatocytes in liver of female rat were observed at the recovery period. Minimal to mild degree of eosinophilic bodies in tubular cells in kidney was observed in male rat and minimal hypertrophy of follicular cells in thyroids was observed in female rats at 125 mg/kg/day as compared to control. Therefore, the No Observed Adverse Effect Level (NOAEL) was considered to be 30 mg/kg/day when Sprague Dawley [Crl:CD()SD] male and female rats were treated with the test chemical for 28 days. Repeated dose toxicity: Inhalation The repeated dose inhalation toxicity study need not be conducted because exposure to humans via inhalation route is not likely taking into account due to the low vapour pressure of the test chemical, which is reported to be 0.123 mm Hg. Thus, exposure to inhalable dust, mist and vapour of the chemical is highly unlikely. Therefore this study for repeated dose toxicity by inhalation route of exposure is considered for waiver. Repeated dose toxicity: Dermal The acute dermal toxicity value forβ- bromostyrene (CAS no 103-64-0)(as provided in section 7.2.3) is >2000 mg/kg body weight. Considering this, the end point for repeated dermal toxicity is considered as waiver. ",2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/25f8033b-edec-4ec0-80e8-a3bc284175da/documents/457802c0-da77-46bc-aad2-76f72ffa2caa_bc24f26a-96ae-4da7-90a2-f8b2a48086f3.html,,,,,, β-bromostyrene,103-64-0,,2025-01-28,Inactive,RepeatedDose,https://chem.echa.europa.eu/html-pages/25f8033b-edec-4ec0-80e8-a3bc284175da/documents/457802c0-da77-46bc-aad2-76f72ffa2caa_bc24f26a-96ae-4da7-90a2-f8b2a48086f3.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,30 mg/kg bw/day,,rat β-bromostyrene,103-64-0," Acute oral toxicity:  The acute oral toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The LD50 value is between 300-2000 mg/kg bw for acute oral toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical can be classified as “Category IV” for acute oral toxicity. Acute Inhalation Toxicity: Test chemicalhas very low vapour pressure (16.4 Pa= 0.1230101 mmhg),So the potential for the generation of inhalable vapours is very low. Also the normal conditions of use of this substance will not result in aerosols, particles or droplets of an inhalable size, so exposure to humans via the inhalatory route will be highly unlikely and therefore the acute inhalation toxicity end point was considered for waiver.   Acute Dermal toxicity: The acute dermal toxicity dose (LD50) was considered based on different studies conducted on rats for the test chemical. The studies concluded that LD50 value is >2000 mg/kg bw for acute dermal toxicity. Thus, comparing this value with the criteria of CLP regulation, the given test chemical cannot be classified for acute dermal toxicity. ",2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25f8033b-edec-4ec0-80e8-a3bc284175da/documents/0d73f5f3-d3b3-4382-aebb-7a853ca12559_bc24f26a-96ae-4da7-90a2-f8b2a48086f3.html,,,,,, β-bromostyrene,103-64-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25f8033b-edec-4ec0-80e8-a3bc284175da/documents/0d73f5f3-d3b3-4382-aebb-7a853ca12559_bc24f26a-96ae-4da7-90a2-f8b2a48086f3.html,,oral,LD50,"1,250 mg/kg bw",adverse effect observed, β-bromostyrene,103-64-0,,2025-01-28,Inactive,AcuteToxicity,https://chem.echa.europa.eu/html-pages/25f8033b-edec-4ec0-80e8-a3bc284175da/documents/0d73f5f3-d3b3-4382-aebb-7a853ca12559_bc24f26a-96ae-4da7-90a2-f8b2a48086f3.html,,dermal,LD50,"6,000 mg/kg bw",no adverse effect observed, γ-methylaziridine-1-propylamine,74993-03-6,"Two acute oral toxicity studies were conducted on C4 Amin. The result of the studies were:- The rat oral LD50 is greater than 200 mg/kg and less than 2,000 mg/kg when tested according to OECD 423.- The rat oral LD50 is 540 mg/kg when tested according to a protocol developed by Litchfield and Wilcoxon. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/a7c198a8-866d-438b-b360-2d6704f0eb2b/documents/IUC5-b0c332c2-0b96-4857-9a99-5ccd8d470232_eabdfa21-e0cc-4d83-aebe-3e99c18399b2.html,,,,,, "ε-Caprolactone, oligomeric reaction products with 2,2'-oxydiethanol",36890-68-3," An OECD 422 screening study is available with the submission substance ϵ-caprolactone, oligomeric reaction products with 2,2’-oxydiethanol. ",2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97279f85-8f13-47ae-bf04-05275395f0bd/documents/79d635f5-6f38-48a6-a030-5d241b98f776_25714802-69af-4e6a-bc40-ce9c372e7387.html,,,,,, "ε-Caprolactone, oligomeric reaction products with 2,2'-oxydiethanol",36890-68-3,,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/97279f85-8f13-47ae-bf04-05275395f0bd/documents/79d635f5-6f38-48a6-a030-5d241b98f776_25714802-69af-4e6a-bc40-ce9c372e7387.html,Short-term repeated dose toxicity – systemic effects,oral,NOAEL,"1,000 mg/kg bw/day",,rat "ε-Caprolactone, oligomeric reaction products with 2,2'-oxydiethanol",36890-68-3," An acute oral toxicity study in rats, conducted according to OECD Test Guideline 401, has been carried out using ε-Caprolactone, oligomeric reaction products with 2,2'-oxydiethanol. No data are available for acute dermal and inhalation toxicity. An acute dermal toxicity study is not required since the substance has been shown not to be acutely toxic by the oral route when dosed at the limit dose 2000 mg/kg bw. An acute inhalation toxicity study is not required due to the physicochemical properties of the substance. ",2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/97279f85-8f13-47ae-bf04-05275395f0bd/documents/c8a446e1-f210-4cc1-8e2c-0fc5d7fcf947_25714802-69af-4e6a-bc40-ce9c372e7387.html,,,,,, "ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol",37625-56-2,No data are available: a testing proposal for a 90-day rat study using oral dosing is proposed. ,2025-01-28,Active,RepeatedDose,https://chem.echa.europa.eu/html-pages/622a215b-8f8e-48e5-bdf0-eef2a1c9ca2e/documents/IUC5-b20ca793-6992-4f22-9db9-81856756e9bb_7cdf5533-159c-4ebd-926f-91acb863d9a6.html,,,,,, "ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol",37625-56-2, An acute oral toxicity study is available for CAPA 3050. A waiver is proposed for acute inhalation toxicity based on the availability of an acute oral toxicity study and the lack of potential exposure. A waiver is proposed for acute dermal toxicity based on the low acute oral toxicity of the substance (LD50 >2000 mg/kg bw). ,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/622a215b-8f8e-48e5-bdf0-eef2a1c9ca2e/documents/IUC5-27f3f61a-9fc3-451e-8af4-a53ad0891d55_7cdf5533-159c-4ebd-926f-91acb863d9a6.html,,,,,, "ε-Caprolactone, oligomeric reaction products with propylidynetrimethanol",37625-56-2,,2025-01-28,Active,AcuteToxicity,https://chem.echa.europa.eu/html-pages/622a215b-8f8e-48e5-bdf0-eef2a1c9ca2e/documents/IUC5-27f3f61a-9fc3-451e-8af4-a53ad0891d55_7cdf5533-159c-4ebd-926f-91acb863d9a6.html,,oral,LD50,"2,000 mg/kg bw",no adverse effect observed,